,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32343190,Age and pre quit-day attrition during smoking cessation treatment.,"The present study aimed to replicate the finding that younger age predicts higher pre quit-day attrition. Our second aim was to explain this relation by examining empirically and theoretically informed age-related risk factors for low smoking cessation treatment engagement. 136 participants ( M   age  = 44.2 years,  SD  = 11.3 years;  age  = 22-64 years) were randomized to 15-weeks of either 1) an exercise intervention ( n  = 72) or 2) a wellness education control condition ( n  = 64). First, a logistic regression analysis was employed to test whether younger adults were more likely than older adults to drop prior to quit date. Next, we assessed whether smoking related health concerns, social expectancies, and/or perceived severity of craving affected the strength of the relation between age and attrition, by adding these three variables to the logistic regression along with age. The logistic regression model indicated that younger age and treatment condition were significantly related to the odds of dropping from treatment prior to the scheduled quit date. Further, health concerns, social expectancies, and/or perceived severity of cravings did not account for the effect of age on pre quit-day attrition. These findings highlight the importance of identifying empirically and theoretically informed variables associated with the pre quit-day attrition problem of young smokers.",2020,The logistic regression model indicated that younger age and treatment condition were significantly related to the odds of dropping from treatment prior to the scheduled quit date.,"['136 participants ( M age \xa0=\xa044.2\xa0years,  SD\xa0 =\xa011.3\xa0years;  age\xa0 =\xa022-64\xa0years']",['exercise intervention ( n  =\xa072) or 2) a wellness education control condition'],"['health concerns, social expectancies, and/or perceived severity of cravings']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",136.0,0.0257536,The logistic regression model indicated that younger age and treatment condition were significantly related to the odds of dropping from treatment prior to the scheduled quit date.,"[{'ForeName': 'Haley E', 'Initials': 'HE', 'LastName': 'Conroy', 'Affiliation': 'Department of Psychology, University of Houston , Houston, TX, USA.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Jacquart', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, University of Texas at Austin , Austin, TX, USA.'}, {'ForeName': 'Scarlett O', 'Initials': 'SO', 'LastName': 'Baird', 'Affiliation': 'Veteran Affairs San Diego Healthcare System , San Diego, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University , Dallas, TX, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Davis', 'Affiliation': 'Big Health, Ltd , San Francisco, CA, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Powers', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, University of Texas at Austin , Austin, TX, USA.'}, {'ForeName': 'Georita M', 'Initials': 'GM', 'LastName': 'Frierson', 'Affiliation': ""School of Arts, Sciences, and Education, D'Youville College , Buffalo, NY, USA.""}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University , Providence, RI, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychology and Department of Psychological and Brain Sciences, Boston University , Boston, MA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston , Houston, TX, USA.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Department of Psychology, Institute for Mental Health Research, University of Texas at Austin , Austin, TX, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2020.1751262']
1,32340343,"Combined Black Rice Germ, Bran Supplement and Exercise Intervention Modulate Aging Biomarkers and Improve Physical Performance and Lower-Body Muscle Strength Parameters in Aging Population.","Aging is a time-dependent functional decline in muscle mass and strength, which is reflected in poor physical performances, hormonal imbalance, and development of chronic low-grade inflammation. This study aimed to assess the effectiveness of black rice germ, bran supplement, and exercise program either alone or in combination for 24 weeks on the aging biomarkers (C-reactive protein, Interleukin-6, Insulin-like growth factor-1, and CD4:CD8 T cell ratio) physical performance, muscle strength parameters (walking speed, sit-to-stand time, grip strength) among Thai aging population. A total of 120 healthy volunteers aged 65-74 years were assigned to the exercise group (EX), black rice germ, and bran supplement (BR) group or the combination of BR and EX group (BR + EX). Over the course of the 24-week intervention, compared with baseline data (T0), the combined BR + EX intervention significantly decreased the inflammatory biomarkers (C-reactive protein and interleukin-6 levels, both  p  < 0.05 vs. T0) and significantly increased the insulin-like growth factor-1 levels ( p  < 0.001 vs. T0). Significant improvement in physical performance and muscle strength were also observed in the combined BR + EX group (decrease in sit-to-stand time and gait speed over the 24-week intervention, both  p  < 0.05 vs. T0, and trend toward grip strength improvement at  p  = 0.088 vs. T0). Overall, our results indicated a synergistic effect towards the combined intervention with the sustainable improvement in physical performances, lower-body muscle strength, and the modulation of both inflammatory and endocrine biomarkers. This study could encourage older adults to change their lifestyles to improve healthy aging and longevity.",2020,"Significant improvement in physical performance and muscle strength were also observed in the combined BR + EX group (decrease in sit-to-stand time and gait speed over the 24-week intervention, both  p  < 0.05 vs. T0, and trend toward grip strength improvement at  p  = 0.088 vs. T0).","['Thai aging population', 'Aging Population', 'older adults', '120 healthy volunteers aged 65-74 years']","['exercise group (EX), black rice germ, and bran supplement (BR) group or the combination of BR and EX group (BR + EX', 'combined BR + EX', 'black rice germ, bran supplement, and exercise program either alone or in combination', 'Combined Black Rice Germ, Bran Supplement and Exercise Intervention', 'combined BR + EX intervention']","['aging biomarkers (C-reactive protein, Interleukin-6, Insulin-like growth factor-1, and CD4:CD8 T cell ratio) physical performance, muscle strength parameters (walking speed, sit-to-stand time, grip strength', 'sit-to-stand time and gait speed', 'insulin-like growth factor-1 levels', 'grip strength improvement', 'physical performance and muscle strength', 'physical performances, lower-body muscle strength, and the modulation of both inflammatory and endocrine biomarkers', 'inflammatory biomarkers (C-reactive protein and interleukin-6 levels']","[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C3257691', 'cui_str': 'Rice germ preparation'}, {'cui': 'C0353942', 'cui_str': 'Bran'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}]",120.0,0.0145485,"Significant improvement in physical performance and muscle strength were also observed in the combined BR + EX group (decrease in sit-to-stand time and gait speed over the 24-week intervention, both  p  < 0.05 vs. T0, and trend toward grip strength improvement at  p  = 0.088 vs. T0).","[{'ForeName': 'Mathuramat', 'Initials': 'M', 'LastName': 'Seesen', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Warathit', 'Initials': 'W', 'LastName': 'Semmarath', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Supachai', 'Initials': 'S', 'LastName': 'Yodkeeree', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Ratana', 'Initials': 'R', 'LastName': 'Sapbamrer', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Pisittawoot', 'Initials': 'P', 'LastName': 'Ayood', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Rungnapa', 'Initials': 'R', 'LastName': 'Malasao', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Krongporn', 'Initials': 'K', 'LastName': 'Ongprasert', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Jiraporn', 'Initials': 'J', 'LastName': 'Chittrakul', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Penprapa', 'Initials': 'P', 'LastName': 'Siviroj', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Pornngarm', 'Initials': 'P', 'LastName': 'Limtrakul Dejkriengkraikul', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17082931']
2,32341187,"Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorder.","OBJECTIVE


To assess the dose-response of daridorexant, a new dual orexin receptor antagonist, on wake after sleep onset (WASO).
METHODS


Elderly (≥65 years) participants (n = 58) with insomnia were randomly allocated (Latin square design) to receive 5 treatments (5, 10, 25, and 50 mg daridorexant and placebo) during 5 treatment periods, each consisting of 2 treatment nights followed by a 5- to 12-day washout period. Main efficacy endpoints were the absolute change from baseline in WASO (primary) and latency to persistent sleep (LPS; secondary) to days 1 and 2 (mean of 2 treatment nights assessed by polysomnography) in each period. Safety and tolerability were also assessed.
RESULTS


Of 58 participants included, 67% were female, and the median age was 69 years (range 65-85 years). WASO and LPS were dose-dependently reduced from baseline to days 1 and 2 after daridorexant administration (multiple comparison procedure modeling,  p  < 0.0001 and  p  = 0.004, respectively); reductions were statistically significant for doses ≥10 mg compared with placebo (WASO: -32.0, -45.1, -61.4 minutes; LPS: -44.9, -43.8, -45.4 minutes for 10, 25, and 50 mg, respectively,  p  ≤ 0.025). Treatment-emergent adverse events were similar for daridorexant and placebo; the most frequent were fatigue, nasopharyngitis, gait disturbance, and headache (≤7% in any group).
CONCLUSIONS


Daridorexant was well tolerated. Dose-dependent improvements in WASO and LPS were statistically significant (dose range 10-50 mg) in elderly people with insomnia disorder.
CLINICALTRIALSGOV IDENTIFIER


NCT02841709.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that, for elderly people with insomnia, daridorexant reduced WASO.",2020,"WASO and LPS were dose-dependently reduced from baseline to days 1 and 2 after daridorexant administration (multiple comparison procedure modeling,  ","['elderly people with insomnia, daridorexant reduced WASO', 'elderly people with insomnia disorder', 'elderly subjects with insomnia disorder', 'Of 58 participants included, 67% were female, and the median age was 69 years (range 65-85 years', 'Elderly (≥65 years) participants (n = 58) with insomnia']","['placebo', 'daridorexant', 'daridorexant and placebo', 'Daridorexant']","['Safety and tolerability', 'tolerated', 'WASO and LPS', 'absolute change from baseline in WASO (primary) and latency to persistent sleep (LPS; secondary) to days 1 and 2 (mean of 2 treatment nights assessed by polysomnography', 'fatigue, nasopharyngitis, gait disturbance, and headache']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0575081', 'cui_str': 'Abnormal gait'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",58.0,0.194625,"WASO and LPS were dose-dependently reduced from baseline to days 1 and 2 after daridorexant administration (multiple comparison procedure modeling,  ","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany. gzammit@clinilabs.com ydauvilliers@yahoo.fr.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany. gzammit@clinilabs.com ydauvilliers@yahoo.fr.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Pain', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany.'}, {'ForeName': 'Dalma', 'Initials': 'D', 'LastName': 'Sebök Kinter', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany.'}, {'ForeName': 'Yosef', 'Initials': 'Y', 'LastName': 'Mansour', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Kunz', 'Affiliation': 'From the Clinilabs Drug Development Corporation (G.Z.); Icahn School of Medicine at Mount Sinai (G.Z.), New York, NY; Unité du Sommeil (Y.D.), Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France; Idorsia Pharmaceuticals Ltd (S.P., D.S.K., Y.M.), Allschwil, Switzerland; and Intellux Berlin GmbH (D.K.), Germany.'}]",Neurology,['10.1212/WNL.0000000000009475']
3,32279099,"Comment on the article ""The antifibrinolytic and anti-inflammatory effects of a high initial-dose tranexamic acid in total knee arthroplasty: a randomized controlled trial"".",,2020,,['total knee arthroplasty'],['tranexamic acid'],[],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",[],,0.103612,,"[{'ForeName': 'Saubhik', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, 834009, India. drsaubhikk@hotmail.com.'}]",International orthopaedics,['10.1007/s00264-020-04554-5']
4,32348009,The effect of partial pulpotomy with iRoot BP Plus in traumatized immature permanent teeth: A randomized prospective controlled trial.,"BACKGROUND/AIM


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


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


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


iRoot BP Plus may be an effective capping material for partial pulpotomy.",2020,"There were no intergroup differences in the survival rate, survival time, root length and dentin wall thickness.","['Traumatised Immature Permanent Teeth', 'immature permanent teeth with complicated crown fracture or complicated crown-root fracture', '110 immature permanent teeth with complicated crown fracture or complicated crown-root fracture']","['calcium hydroxide (control group,n=49) as the pulp capping agent', 'iRoot BP', 'partial pulpotomy with iRoot BP Plus', 'Partial Pulpotomy with iRoot BP Plus', 'calcium hydroxide', 'bioceramic material iRoot BP']","['survival rate, survival time, root length and dentin wall thickness', 'calcific bridge']","[{'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936256', 'cui_str': 'Pulp Capping Agents'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C4043153', 'cui_str': 'iRoot BP Plus'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}]",11.0,0.0477762,"There were no intergroup differences in the survival rate, survival time, root length and dentin wall thickness.","[{'ForeName': 'YingTing', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'The Third Clinical Division of Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xia', 'Affiliation': 'Department of Pediatric Dentistry, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Pediatric Dentistry, The Center for Pediatric Dentistry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Guili', 'Initials': 'G', 'LastName': 'Dou', 'Affiliation': 'Department of Pediatric Dentistry, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'The Third Clinical Division of Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yong', 'Affiliation': 'Department of General Dentistry, Peking University School and Hospital of Stomatology, Beijing, China.'}]",Dental traumatology : official publication of International Association for Dental Traumatology,['10.1111/edt.12563']
5,32344105,The after-effect of noisy galvanic vestibular stimulation on postural control in young people: A randomized controlled trial.,"Noisy galvanic vestibular stimulation (nGVS) enhances the vestibular system. The center of pressure (COP) sway has been shown to decrease during nGVS, but the after-effect of nGVS remains unclear. The aim of this study is to elucidate the after-effect of nGVS on COP sway. We randomly assigned 26 participants to either control (sham stimulation) or nGVS groups. All participants were measured for COP sway while standing with open eyes at baseline, during stimulation, and after stimulation. In the nGVS group, sway path length, mediolateral mean velocity, and anteroposterior mean velocity decreased both during stimulation and after stimulation compared with baseline. Conversely, no significant difference in COP sway was detected in the control group. There was a correlation between the stimulation effect and the after-effect in the nGVS group, indicating that nGVS is effective for people with high baseline COP sway.",2020,"In the nGVS group, sway path length, mediolateral mean velocity, and anteroposterior mean velocity decreased both during stimulation and after stimulation compared with baseline.",['young people'],"['noisy galvanic vestibular stimulation', 'nGVS', 'control (sham stimulation) or nGVS', 'Noisy galvanic vestibular stimulation (nGVS']","['sway path length, mediolateral mean velocity, and anteroposterior mean velocity', 'COP sway', 'postural control']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",26.0,0.0573894,"In the nGVS group, sway path length, mediolateral mean velocity, and anteroposterior mean velocity decreased both during stimulation and after stimulation compared with baseline.","[{'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Inukai', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan. Electronic address: inukai@nuhw.ac.jp.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Otsuru', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Miyaguchi', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Hirotake', 'Initials': 'H', 'LastName': 'Yokota', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Onishi', 'Affiliation': 'Department of Physical Therapy, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan; Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, 1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135009']
6,32344455,Pregnane X Receptor Activator Rifampin Increases Blood Pressure and Stimulates Plasma Renin Activity.,"We conducted a clinical trial with 22 healthy volunteers to investigate the effects of pregnane X receptor (PXR) agonist rifampin on blood pressure (BP). The study was randomized, crossover, single-blind, and placebo-controlled. Rifampin 600 mg or placebo once daily was administered for a week and the 24-hour ambulatory BP was monitored at the end of each arm on the eighth day. Rifampin elevated the mean systolic and diastolic 24-hour BP (4.7 mmHg, P < 0.0001, and 3.0 mmHg, P < 0.001, respectively) as well as the mean heart rate (3.5 bpm, P = 0.038). The serum renin concentration and the plasma renin activity were increased. Although rifampin increased circulating 4β-hydroxycholesterol (4βHC) as expected, the plasma 4βHC concentration strongly negatively correlated with 24-hour BP, especially systolic, in both rifampin and placebo arms (rifampin systolic BP, r = -0.69, P < 0.001; placebo systolic BP, r = -0.70, P < 0.001). The 4βHC, an agonist for liver X receptor (LXR), induced renin expression modestly in LXR-α expressing Calu-6 cells but only at unphysiologically high 4βHC concentrations. In conclusion, rifampin stimulates renin activity and has a hypertensive effect. This finding should be considered when designing interaction studies involving rifampin or other PXR agonists. Furthermore, PXR may represent a putative therapeutic target for the treatment of hypertension.",2020,"Rifampin elevated the mean systolic and diastolic 24hr BP (4.7 mmHg, P < 0.0001, and 3.0 mmHg, P < 0.001, respectively) as well as the mean heart rate (3.5 bpm, P = 0.038).",['22 healthy volunteers'],"['Pregnane X receptor activator rifampin', 'Rifampin 600 mg or placebo', 'pregnane X receptor (PXR) agonist rifampin', 'rifampin', 'placebo']","['mean systolic and diastolic 24hr BP', 'blood pressure and stimulates plasma renin activity', 'blood pressure (BP', 'plasma 4βHC concentration', 'serum renin concentration and the plasma renin activity', 'circulating 4β-hydroxycholesterol (4βHC', 'mean heart rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0671771', 'cui_str': 'SXR Receptor'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C1104996', 'cui_str': 'Rifampin 600 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0020339', 'cui_str': 'Hydroxycholesterols'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",22.0,0.133873,"Rifampin elevated the mean systolic and diastolic 24hr BP (4.7 mmHg, P < 0.0001, and 3.0 mmHg, P < 0.001, respectively) as well as the mean heart rate (3.5 bpm, P = 0.038).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Hassani-Nezhad-Gashti', 'Affiliation': 'Research Unit of Biomedicine, Pharmacology and Toxicology, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Tuire', 'Initials': 'T', 'LastName': 'Salonurmi', 'Affiliation': 'Biocenter Oulu, Oulu, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hautajärvi', 'Affiliation': 'Admescope Ltd., Oulu, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Rysä', 'Affiliation': 'School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Hakkola', 'Affiliation': 'Research Unit of Biomedicine, Pharmacology and Toxicology, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Hukkanen', 'Affiliation': 'Biocenter Oulu, Oulu, Finland.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1871']
7,32344728,Impact of Active and Passive Hypoxia as Re-Warm-Up Activities on Rugby Players' Performance.,"The aim of this study was to analyse the effect of four types of re-warm-up (R-WU) activity, namely rest in normoxia (RN) at FiO 2  = 20.9%, rest in hypoxia (RH) at FiO 2  = 15%, activity (4 × 5 jumps/15 s) in normoxia (AN) and activity in hypoxia (AH) on physical performance. Ten elite male rugby players completed a 15-min warm-up followed by one of the 15-min randomized R-WU strategies. After R-WU, countermovement jump (CMJ), 20 m sprint and repeat sprint ability (RSA) tests were assessed. Compared to passive strategies (RN and RH), tympanic temperature was higher after active R-WU (AN and AH) ( p  = 0.016). Higher values of CMJ height ( p  = 0.037) and 20 m sprint ( p  = 0.02) were found in AH than in RN. In addition, mean RSA was lower ( p  = 0.008) in AH than in RN and RH. Blood lactate concentration was higher ( p  = 0.007) after RN and AN strategies than after AH. Muscle O 2  saturation ( p  = 0.021) and total Hb ( p  = 0.042) were higher after AH than after the other three conditions and after RN, respectively. Therefore, an active R-WU under hypoxia could be useful to elite rugby players, once it had attenuated the decline in tympanic temperature during a 15-min period after warm-up, improving jump, sprint and RSA performance.",2020,"Muscle O 2  saturation ( p  = 0.021) and total Hb ( p  = 0.042) were higher after AH than after the other three conditions and after RN, respectively.",['Ten elite male rugby players'],"['re-warm-up (R-WU) activity, namely rest in normoxia (RN', 'Active and Passive Hypoxia as Re-Warm-Up Activities']","['mean RSA', 'Muscle O 2  saturation', 'countermovement jump (CMJ), 20 m sprint and repeat sprint ability (RSA) tests', 'CMJ height', 'total Hb', 'normoxia (AN) and activity in hypoxia (AH) on physical performance', 'passive strategies (RN and RH), tympanic temperature', 'Blood lactate concentration']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",10.0,0.034329,"Muscle O 2  saturation ( p  = 0.021) and total Hb ( p  = 0.042) were higher after AH than after the other three conditions and after RN, respectively.","[{'ForeName': 'Domingo Jesús', 'Initials': 'DJ', 'LastName': 'Ramos-Campo', 'Affiliation': 'Faculty of Sports, UCAM, Catholic University San Antonio, 30107 Murcia, Spain.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Malta', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, 7000-645 Évora, Portugal.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Olcina', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Timón', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Raimundo', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, 7000-645 Évora, Portugal.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Tomas-Carus', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, 7000-645 Évora, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17082971']
8,32329069,Development and validation of a novel epigenetic signature for predicting prognosis in colon cancer.,"Epigenetic factors play a critical role in carcinogenesis by imparting a distinct feature to the chromatin architecture. The present study aimed to develop a novel epigenetic signature for evaluating the relapse-free survival of colon cancer patients. Public microarray datasets were acquired from the Gene Expression Omnibus databases: GSE39582, GSE17538, GSE33113, and GSE37892 set. Patients from GSE39582 set were randomized 1:1 into training and internal validation series. Patients were divided into high-risk and low-risk groups in training series based on a set of 11 epigenetic factors (p < .001). The good reproducibility for the prognostic value of the epigenetic signature was confirmed in the internal validation series (p < .001), external validation series (a combination of GSE17538 set, GSE33113 set, and GSE37892 set; p = .018), and entire series (p < .001). Furthermore, a nomogram, which integrated the epigenetic signature, pathological stage, and postoperative chemotherapy, was developed based on the GSE39582 set. The time-dependent receiver operating characteristic curve at 1 year demonstrated that the comprehensive signature presented superior prognostic value than the pathological stage. In conclusion, an epigenetic signature, which could be utilized to divide colon cancer patients into two groups with significantly different risk of relapse, was established. This biomarker would aid in identifying patients who require an intensive follow-up and aggressive therapeutic intervention.",2020,"The good reproducibility for the prognostic value of the epigenetic signature was confirmed in the internal validation series (p < .001), external validation series (a combination of GSE17538 set, GSE33113 set, and GSE37892 set; p = .018), and entire series (p < .001).","['patients who require an intensive follow-up and aggressive therapeutic intervention', 'Patients from GSE39582 set', 'colon cancer', 'colon cancer patients']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]",[],[],,0.0181248,"The good reproducibility for the prognostic value of the epigenetic signature was confirmed in the internal validation series (p < .001), external validation series (a combination of GSE17538 set, GSE33113 set, and GSE37892 set; p = .018), and entire series (p < .001).","[{'ForeName': 'Dakui', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zezhi', 'Initials': 'Z', 'LastName': 'Shan', 'Affiliation': 'Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Sanjun', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qingguo', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xinxiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Journal of cellular physiology,['10.1002/jcp.29715']
9,32344198,Ileo-colonic delivery of conjugated bile acids improves glucose homeostasis via colonic GLP-1-producing enteroendocrine cells in human obesity and diabetes.,"BACKGROUND


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


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


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


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


Research support and drug was provided by Satiogen Pharmaceuticals (San Diego, CA). AA, MC, and NFL report grants (AA- C-Sig P30DK84567, K23 DK114460; MC- NIH R01 DK67071; NFL- R01 DK057993) from the NIH. JR was supported by an Early Career Grant from Society for Endocrinology.",2020,"When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide.","['human obesity and diabetes', 'participants with obesity and diabetes', '307 participants by measuring during fasting and postprandial levels of FGF19, 7αC4 and serum BA; 3) In a']","['placebo, IC-CBAS', 'conjugated bile acids', 'ileo-colonic delivery of conjugated BAs (IC-CBAS', 'FGF19', 'placebo']","['glucose homeostasis', 'weight loss', 'faecal BA', 'obesity and diabetes', 'postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025922', 'cui_str': 'Mouse, Inbred CBA'}, {'cui': 'C0443599', 'cui_str': 'Conjugated bile acids'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",307.0,0.064704,"When compared to placebo, IC-CBAS significantly decreased postprandial glucose, fructosamine, fasting insulin, fasting LDL, and postprandial FGF19 and increased postprandial GLP-1 and C-peptide.","[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Calderon', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McRae', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Rievaj', 'Affiliation': 'University of Cambridge, UK; Current affiliation: Dosage Form Design & Development, AstraZeneca Granta Park, Cambridge CB21 6GH, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Inuk', 'Initials': 'I', 'LastName': 'Zandvakili', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Linker-Nord', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'Current affiliation: Dosage Form Design & Development, AstraZeneca Granta Park, Cambridge CB21 6GH, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reimann', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Gedulin', 'Affiliation': 'Satiogen Pharmaceuticals, San Diego, CA, United States.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Vella', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'LaRusso', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Gribble', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Acosta', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Division of Gastroenterology and Hepatology, Mayo Clinic, Charlton 8-142, 200 First St. S.W., Rochester, MN 55905, United States. Electronic address: acosta.andres@mayo.edu.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102759']
10,32344201,Continuous postoperative pericardial flushing method versus standard care for wound drainage after adult cardiac surgery: A randomized controlled trial.,"BACKGROUND


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


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


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


Our study results indicate that CPPF is a safe and effective method to improve chest tube patency and reduce blood loss after cardiac surgery. Larger trials are needed to draw final conclusions concerning the effectiveness of CPPF on clinically relevant outcomes.",2020,"Cardiac tamponade and reoperation for bleeding did not occur in the study group versus one and three in the control group, respectively.","['wound drainage after adult cardiac surgery', 'Between May 2013 and February 2016, 170 patients', 'Adults undergoing cardiac surgery for non-emergent valvular or congenital heart disease (CHD']","['CPPF', 'CPPF method or standard care', 'Continuous postoperative pericardial flushing method versus standard care', 'CPPF method (study group; n\u202f=\u202f80) or to standard care (control group; n\u202f=\u202f90']","['actual blood loss after 12-hour stay in the intensive care unit (ICU', 'Cardiac tamponade and reoperation for bleeding', 'pleural effusion', 'bleeding-related complications and clinical outcome after six months follow-up', 'blood loss']","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442031', 'cui_str': 'Pericardial'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0553700', 'cui_str': 'Actual blood loss'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0007177', 'cui_str': 'Cardiac tamponade'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",170.0,0.171937,"Cardiac tamponade and reoperation for bleeding did not occur in the study group versus one and three in the control group, respectively.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Diephuis', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. Electronic address: e.c.diephuis@amsterdamumc.nl.'}, {'ForeName': 'Corianne', 'Initials': 'C', 'LastName': 'de Borgie', 'Affiliation': 'Clinical Research Unit, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Tomšič', 'Affiliation': 'Department of Cardiothoracic Surgery, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Winkelman', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Wim Jan', 'Initials': 'WJ', 'LastName': 'van Boven', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Berto', 'Initials': 'B', 'LastName': 'Bouma', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Eberl', 'Affiliation': 'Department of Anesthesiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Juffermans', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Schultz', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Jose P', 'Initials': 'JP', 'LastName': 'Henriques', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Koolbergen', 'Affiliation': 'Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Location AMC, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands; Department of Cardiothoracic Surgery, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102744']
11,32351061,[Systemic enzyme therapy for treatment of women with chronic recurrent bacterial cystitis].,"INTRODUCTION


In most cases, treatment of infectious and inflammatory diseases, including lower urinary tract infections, includes antibacterial drugs. However, their efficiency decreases every year. The absence of new groups of antibiotics makes it necessary to develop alternative treatment schemes and methods for improving efficiency of existing drugs. Systemic enzyme therapy is one of the promising directions in the treatment of lower urinary tract infections, which was shown to be effective for treating a number of diseases.
AIM


to evaluate the results of complex treatment of women with chronic recurrent bacterial cystitis using a drug for systemic enzyme therapy.
MATERIALS AND METHODS


The examination and treatment of 60 women aged 19 to 45 years with an exacerbation of chronic recurrent bacterial cystitis, who were randomly divided into two groups of 30 patients, was performed. In the group 1, patients received standard antibiotic therapy. In the group 2, women additionally received Phlogenzym. An evaluation of the efficiency was carried out on the 1st, 7th and 14th day and included analysis of lower urinary tract symptoms, according to bladder diaries, assessment of pain intensity and laboratory tests (C-reactive protein [CRP], IL-6, IL-1, TNF. During long-term follow-up (6 months after completion of treatment), the relapse rate was evaluated in both groups.
RESULTS


At admission, all women had clinical and laboratory signs of cystitis. By the 14th day, there was normalization of evaluated parameters in both groups. However, in patients receiving systemic enzyme therapy a more rapid relief of the inflammatory process (a decrease in the frequency of urination, urgency, nocturia, severity of inflammatory changes in the blood and urine) by the 7th day of treatment was observed. During a further 6-month follow-up, relapses were detected in 9 (30%) and 4 (13.3%) patients in group 1 and 2, respectively.
CONCLUSION


The results of the study demonstrated the high efficiency of systemic enzyme therapy. Its use for complex treatment provides more rapid relief of lower urinary tract symptoms and pain, as well as reduces the number of relapses in women with chronic recurrent bacterial cystitis.",2020,"By the 14th day, there was normalization of evaluated parameters in both groups.","['60 women aged 19 to 45 years with an exacerbation of chronic recurrent bacterial cystitis', 'women with chronic recurrent bacterial cystitis using a drug for systemic enzyme therapy', 'women with chronic recurrent bacterial cystitis']","['systemic enzyme therapy', 'Systemic enzyme therapy', 'Phlogenzym', 'standard antibiotic therapy']","['frequency of urination, urgency, nocturia, severity of inflammatory changes in the blood and urine', 'clinical and laboratory signs of cystitis', 'rapid relief of the inflammatory process', 'bladder diaries, assessment of pain intensity and laboratory tests (C-reactive protein [CRP], IL-6, IL-1, TNF', 'relapse rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1959870', 'cui_str': 'Recurrent bacterial cystitis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2936197', 'cui_str': 'Enzymotherapy'}]","[{'cui': 'C2936197', 'cui_str': 'Enzymotherapy'}, {'cui': 'C0769132', 'cui_str': 'Phlogenzym'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",60.0,0.01888,"By the 14th day, there was normalization of evaluated parameters in both groups.","[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': ""Kuz'menko"", 'Affiliation': 'Department of Urology of FGBOU VO Voronezh State Medical University named after N.N. Burdenko, Voronezh, Russia.'}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': ""Kuz'menko"", 'Affiliation': 'Department of Urology of FGBOU VO Voronezh State Medical University named after N.N. Burdenko, Voronezh, Russia.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Gyaurgiev', 'Affiliation': 'Department of Urology of FGBOU VO Voronezh State Medical University named after N.N. Burdenko, Voronezh, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
12,32350320,Transcutaneous Electrical Nerve Stimulation Improves Stair Climbing Capacity in People with Knee Osteoarthritis.,"This study aimed to examine the effect of transcutaneous electrical nerve stimulation (TENS) on stair climbing capacity in individuals with pre-radiographic to mild knee osteoarthritis (OA). This is a secondary analysis of data from a single, participant-blinded, randomized controlled trial with a pre-post design. Participants with pre-radiographic to mild knee OA (mean age, 59.1 years; 72.9% women) were randomly assigned into two groups, a TENS (n = 30) and a sham-TENS groups (n = 29). TENS or sham-TENS treatments were applied to all participants by using the prototype TENS device with pre-specified parameters. The primary outcome measures included valid and reliable functional measures for stair climbing (stair-climb test [SCT]), visual analog scale for knee pain during the SCT, and quadriceps muscle strength. TENS improved SCT time by 0.41 s (95% confidence interval [CI]: 0.07, 0.75). The time reduction in the transition phase explains the TENS therapeutic effect. Post-hoc correlation analyses revealed a non-significant but positive relationship between the pain relief effect and improved 11-step SCT time in the TENS group but not in the sham-TENS group. These results indicate that the TENS intervention may be an option for reducing the burden of early-stage knee OA.",2020,"TENS improved SCT time by 0.41 s (95% confidence interval [CI]: 0.07, 0.75).","['People with Knee Osteoarthritis', 'individuals with pre-radiographic to mild knee osteoarthritis (OA', 'Participants with pre-radiographic to mild knee OA (mean age, 59.1 years; 72.9% women']","['TENS', 'Transcutaneous Electrical Nerve Stimulation', 'TENS intervention', 'TENS or sham-TENS', 'transcutaneous electrical nerve stimulation (TENS', 'sham-TENS']","['burden of early-stage knee OA', 'SCT time', 'valid and reliable functional measures for stair climbing (stair-climb test [SCT]), visual analog scale for knee pain during the SCT, and quadriceps muscle strength', 'pain relief effect and improved 11-step SCT time', 'stair climbing capacity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0796149', 'cui_str': 'Scott syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",,0.0636887,"TENS improved SCT time by 0.41 s (95% confidence interval [CI]: 0.07, 0.75).","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iijima', 'Affiliation': 'Department of System Design Engineering, Faculty of Science and Technology, Keio University, Yokohama, Japan. iijima.hirotaka.4m@yt.sd.keio.ac.jp.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Eguchi', 'Affiliation': 'School of Science for Open and Environmental Systems, Graduate School of Science and Technology, Keio University, Yokohama, Japan.'}, {'ForeName': 'Kanako', 'Initials': 'K', 'LastName': 'Shimoura', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Aoyama', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Department of System Design Engineering, Faculty of Science and Technology, Keio University, Yokohama, Japan.'}]",Scientific reports,['10.1038/s41598-020-64176-0']
13,32353544,Medication treatment for opioid use disorder in expectant mothers (MOMs): Design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations.,"Opioid use disorder (OUD) in pregnant women has increased significantly in recent years. Maintaining these women on sublingual (SL) buprenorphine (BUP) is an evidence-based practice but BUP-SL is associated with several disadvantages that an extended-release (XR) BUP formulation could eliminate. The National Drug Abuse Treatment Clinical Trials Network (CTN) is conducting an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial, Medication treatment for Opioid-dependent expectant Mothers (MOMs), to compare mother and infant outcomes of pregnant women with OUD treated with BUP-XR, relative to BUP-SL. A second aim is to determine the relative economic value of utilizing BUP-XR. Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization. Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in two sub-studies to evaluate the: 1) mechanisms by which BUP-XR may improve mother and infant outcomes; and 2) effects of prenatal exposure to BUP-XR versus BUP-SL on infant neurodevelopment. This paper describes the key design decisions for the main trial made during protocol development. This Investigational New Drug (IND) trial uniquely uses pragmatic features where feasible in order to maximize external validity, hence increasing the potential to inform clinical practice guidelines and address multiple knowledge gaps for treatment of this patient population.",2020,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","['expectant mothers (MOMs', 'Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30\u202fweeks, recruited from 12 sites', 'pregnant women with OUD treated with BUP-XR, relative to BUP-SL', 'pregnant women']","['sublingual (SL) buprenorphine (BUP', 'buprenorphine formulations', 'prenatal exposure to BUP-XR versus BUP-SL']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],300.0,0.0591114,"Approximately 300 pregnant women with an estimated gestational age (EGA) of 6-30 weeks, recruited from 12 sites, will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, EGA, and BUP-SL status (taking/not taking) at the time of randomization.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lofwall', 'Affiliation': 'Departments of Behavioral Science and Psychiatry, University of Kentucky College of Medicine, Center on Drug and Alcohol Research, 845 Angliana Avenue, Lexington, KY 40508, USA.'}, {'ForeName': 'Hendrée E', 'Initials': 'HE', 'LastName': 'Jones', 'Affiliation': 'UNC Horizons and Department of Obstetrics and Gynecology, University of North Carolina Chapel Hill, 410 North Greensboro St., Carrboro, NC 27510, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Davida M', 'Initials': 'DM', 'LastName': 'Schiff', 'Affiliation': 'Division of General Academic Pediatrics, MassGeneral Hospital for Children, 125 Nashua St Suite 860, Boston, MA 02114, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wexelblatt', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Merhar', 'Affiliation': ""Perinatal Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA; Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, 425 East 61st Street Suite 301, New York, NY 10065, USA.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': ""Department of Psychiatry, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA; Division of Alcohol, Drug and Addictions and the Division of Women's Mental Health, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA.""}, {'ForeName': 'Mishka', 'Initials': 'M', 'LastName': 'Terplan', 'Affiliation': 'Friends Research Institute,1040 Park Ave Suite 103, Baltimore, MD 21201, USA.'}, {'ForeName': 'Elisha M', 'Initials': 'EM', 'LastName': 'Wachman', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, 801 Albany Street, Boston, MA 02119, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Company, LLC, 401 N Washington Street, Suite 700, Rockville, MD 20850, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Medical University of South Carolina, 67 President St., MSC 861, Charleston, SC 29425, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Rosa', 'Affiliation': 'Center for the Clinical Trials Network, National Institute on Drug Abuse, 6001 Executive Blvd, Bethesda, MD 20892, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106014']
14,32350771,Coverage of Sex Acts by Event-Driven Pre-exposure Prophylaxis: A Sub-Study of the ANRS IPERGAY Trial.,"We assessed the coverage of sex acts by event-driven pre-exposure prophylaxis (ED-PrEP) over a 2-month period in 54 participants in the open label phase of the ANRS Ipergay trial. Participants received an electronic monitoring system device to record bottle openings. Self-questionnaires collected daily information on PrEP intake and sexual behavior. Intake was also estimated through returned pill counts. Full coverage of sex acts was defined as at least one pill taken both within 24 h before and within 48 h following sex. There was a strong correlation (r =  - 0.92) between the number of bottle openings and returned pill counts. During the study, 42 participants (78%) practiced ED-PrEP and 12 (22%) daily PrEP with bottle openings at least 5 days/week whatever their sexual activity. Out of the 154 reported receptive anal sex acts, 81% were condomless: among them, PrEP coverage was hight: 97% among those practicing daily PrEP and 82% among those using ED-PrEP.",2020,"Out of the 154 reported receptive anal sex acts, 81% were condomless: among them, PrEP coverage was hight: 97% among those practicing daily PrEP and 82% among those using ED-PrEP.","['42 participants (78%) practiced ED-PrEP and 12 (22%) daily', '54 participants in the open label phase of the ANRS Ipergay trial']","['PrEP', 'Event-Driven Pre-exposure Prophylaxis', 'electronic monitoring system device to record bottle openings']","['Full coverage of sex acts', 'PrEP intake and sexual behavior']","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",42.0,0.0389101,"Out of the 154 reported receptive anal sex acts, 81% were condomless: among them, PrEP coverage was hight: 97% among those practicing daily PrEP and 82% among those using ED-PrEP.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bauer', 'Affiliation': 'Inserm SC10, Villejuif, France. rebecca.bauer@inserm.fr.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Netzer', 'Affiliation': 'Inserm SC10, Villejuif, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Pintado', 'Affiliation': 'Hôpital Saint-Louis, Maladies infectieuses, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Capitant', 'Affiliation': 'Inserm SC10, Villejuif, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cua', 'Affiliation': ""Hôpital de l'Archet, Maladies infectieuses, Nice, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Etien', 'Affiliation': 'ANRS, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Fonsart', 'Affiliation': 'Biochimie Et Biologie Moléculaire, Hôpital Lariboisière, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pialoux', 'Affiliation': 'Hôpital Tenon, Maladies infectieuses, Paris, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Chidiac', 'Affiliation': 'Hôpital de la Croix Rousse, Lyon, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Etienne', 'Affiliation': 'Centre Hospitalier de Grasse, Grasse, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Doré', 'Affiliation': 'ANRS, Paris, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'Inserm SC10, Université Paris Sud, Université Paris Saclay, Villejuif, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Hôpital Saint-Louis, Maladies infectieuses, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-020-02890-6']
15,32290681,HIV-related stigma and quality of life in people living with HIV and depressive symptoms: indirect effects of positive coping and perceived stress.,"Despite a strong evidence on the negative association between HIV-related stigma and quality of life (QoL), few studies have examined the indirect effects of this relationship. This study aimed to examine the association between HIV-related stigma and QoL and the indirect effects of positive coping and perceived stress in people living with HIV and depressive symptoms (PLWHD). This study used baseline date from a randomized controlled trial. Structural equation model was used to examine the association between HIV-related stigma and QoL as well as the indirect effects of positive coping and perceived stress. Perceived and internalized stigma had negative direct ( β  = -0.14,  p  < 0.05) effect on QoL. Moreover, perceived and internalized stigma had indirect effects on QoL through decreased positive coping and increased perceived stress ( β  = -0.23,  p  < 0.001). Multilevel interventions to reduce perceived and internalized stigma and perceived stress as well as programs to enhance positive coping may improve QoL of PLWHD. Integrated interventions that both enhance positive coping and reduce perceived stress and stigma are potentially more effective in improving QoL than programs that focus on only one aspect of stigma reduction among PLWHD.",2020,"Perceived and internalized stigma had negative direct ( β  = -0.14,  p  < 0.05) effect on QoL. Moreover, perceived and internalized stigma had indirect effects on QoL through decreased positive coping and increased perceived stress ( β  = -0.23,  p  < 0.001).","['people living with HIV and depressive symptoms', 'people living with HIV and depressive symptoms (PLWHD']",[],['HIV-related stigma and quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0572221,"Perceived and internalized stigma had negative direct ( β  = -0.14,  p  < 0.05) effect on QoL. Moreover, perceived and internalized stigma had indirect effects on QoL through decreased positive coping and increased perceived stress ( β  = -0.23,  p  < 0.001).","[{'ForeName': 'Mengting', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Chengbo', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'South Carolina SmartState Center for Healthcare Quality, Arnold School of Public Health, University of South Carolina, Colombia, USA.'}, {'ForeName': 'Jiaying', 'Initials': 'J', 'LastName': 'Qiao', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhimeng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': ""Department of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Department of Infectious Disease, Guangzhou Eighth People's Hospital, Guangzhou, People's Republic of China.""}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Disease, Guangzhou Eighth People's Hospital, Guangzhou, People's Republic of China.""}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Infectious Disease, Guangzhou Eighth People's Hospital, Guangzhou, People's Republic of China.""}]",AIDS care,['10.1080/09540121.2020.1752890']
16,32350297,Markers of tissue damage and inflammation after robotic and abdominal hysterectomy in early endometrial cancer: a randomised controlled trial.,"The aim of this study was to analyse the dynamics of tissue damage and inflammatory response markers perioperatively and whether these differ between women operated with robotic and abdominal hysterectomy in treating early-stage endometrial cancer. At a Swedish university hospital fifty women with early-stage low-risk endometrial cancer were allocated to robotic or abdominal hysterectomy in a randomiszed controlled trial. Blood samples reflecting inflammatory responses (high sensitivity CRP, white blood cells (WBC), thrombocytes, IL-6, cortisol) and tissue damage (creatine kinase (CK), high-mobility group box 1 protein (HMGB1)) were collected one week preoperatively, just before surgery, postoperatively at two, 24 and 48 hours, and one and six weeks postoperatively. High sensitivity CRP (p = 0.03), WBC (p < 0.01), IL-6 (p = 0.03) and CK (p = 0.03) were significantly lower in the robotic group, but fast transitory. Cortisol returned to baseline two hours after robotic hysterectomy but remained elevated in the abdominal group comparable to the preoperative high levels for both groups just before surgery (p < 0.0001). Thrombocytes and HMGB1 were not affected by the mode of surgery. Postoperative inflammatory response and tissue damage were lower after robotic hysterectomy compared to abdominal hysterectomy. A significant remaining cortisol elevation two hours after surgery may reflect a higher stress response in the abdominal group.",2020,"(p = 0.03) and CK (p = 0.03) were significantly lower in the robotic group, but fast transitory.","['women operated with robotic and abdominal hysterectomy in treating early-stage endometrial cancer', 'early endometrial cancer', 'Swedish university hospital fifty women with early-stage low-risk endometrial cancer']","['robotic and abdominal hysterectomy', 'robotic or abdominal hysterectomy', 'robotic hysterectomy']","['High sensitivity CRP', 'Blood samples reflecting inflammatory responses (high sensitivity CRP, white blood cells (WBC), thrombocytes, IL-6, cortisol) and tissue damage (creatine kinase (CK), high-mobility group box 1 protein (HMGB1', 'Postoperative inflammatory response and tissue damage', 'WBC', 'Cortisol', 'IL-6', 'Thrombocytes and HMGB1', 'stress response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",50.0,0.135921,"(p = 0.03) and CK (p = 0.03) were significantly lower in the robotic group, but fast transitory.","[{'ForeName': 'Evelyn Serreyn', 'Initials': 'ES', 'LastName': 'Lundin', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden. Evelyn.Lundin@regionostergotland.se.'}, {'ForeName': 'Ninnie Borendal', 'Initials': 'NB', 'LastName': 'Wodlin', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Nilsson', 'Affiliation': 'Department of Anaesthesiology and Intensive Care in Linköping and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Elvar', 'Initials': 'E', 'LastName': 'Theodorsson', 'Affiliation': 'Department of Clinical Chemistry, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ernerudh', 'Affiliation': 'Department of Clinical Immunology and Transfusion Medicine, and Department of Biomedical and Clinical and Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Preben', 'Initials': 'P', 'LastName': 'Kjølhede', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}]",Scientific reports,['10.1038/s41598-020-64016-1']
17,32294257,Mechanisms and impacts of an incentive-based conservation program with evidence from a randomized control trial.,"Conservation science needs more high-quality impact evaluations, especially ones that explore mechanisms of success or failure. Randomized control trials (RCTs) provide particularly robust evidence of the effectiveness of interventions (although they have been criticized as reductionist and unable to provide insights into mechanisms), but there have been few such experiments investigating conservation at the landscape scale. We explored the impact of Watershared, an incentive-based conservation program in the Bolivian Andes, with one of the few RCTs of landscape-scale conservation in existence. There is strong interest in such incentive-based conservation approaches as some argue they can avoid negative social impacts sometimes associated with protected areas. We focused on social and environmental outcomes based on responses from a household survey in 129 communities randomly allocated to control or treatment (conducted both at the baseline in 2010 and repeated in 2015-2016). We controlled for incomplete program uptake by combining standard RCT analysis with matching methods and investigated mechanisms by exploring intermediate and ultimate outcomes according to the underlying theory of change. Previous analyses, focused on single biophysical outcomes, showed that over its first 5 years Watershared did not slow deforestation or improve water quality at the landscape scale. We found that Watershared influenced some outcomes measured using the survey, but the effects were complex, and some were unexpected. We thus demonstrated how RCTs can provide insights into the pathways of impact, as well as whether an intervention has impact. This paper, one of the first registered reports in conservation science, demonstrates how preregistration can help make complex research designs more transparent, avoid cherry picking, and reduce publication bias.",2020,We focused on social and environmental outcomes based on responses from a household survey in 129 communities randomly allocated to control or treatment (conducted both at the baseline in 2010 and repeated in 2015/16).,['129 communities randomly allocated to control or treatment (conducted both at the baseline in 2010 and repeated in 2015/16'],['incentive-based conservation program'],['water quality'],"[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0597680', 'cui_str': 'Water Quality'}]",,0.0477643,We focused on social and environmental outcomes based on responses from a household survey in 129 communities randomly allocated to control or treatment (conducted both at the baseline in 2010 and repeated in 2015/16).,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wiik', 'Affiliation': 'School of Natural Sciences, Deiniol Road, Bangor University, Bangor, LL57 2UW, U.K.'}, {'ForeName': 'Julia P G', 'Initials': 'JPG', 'LastName': 'Jones', 'Affiliation': 'School of Natural Sciences, Deiniol Road, Bangor University, Bangor, LL57 2UW, U.K.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Pynegar', 'Affiliation': 'School of Natural Sciences, Deiniol Road, Bangor University, Bangor, LL57 2UW, U.K.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bottazzi', 'Affiliation': 'School of Natural Sciences, Deiniol Road, Bangor University, Bangor, LL57 2UW, U.K.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Asquith', 'Affiliation': 'Sustainability Science Program, Harvard Kennedy School, Cambridge, MA, 02138, U.S.A.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gibbons', 'Affiliation': 'School of Natural Sciences, Deiniol Road, Bangor University, Bangor, LL57 2UW, U.K.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kontoleon', 'Affiliation': 'Department of Land Economy, University of Cambridge, 19 Silber Street, Cambridge, CB3 9EP, U.K.'}]",Conservation biology : the journal of the Society for Conservation Biology,['10.1111/cobi.13508']
18,32356413,Twelve-hour fasting compared with expedited oral intake in the initial inpatient management of hyperemesis gravidarum: a randomised trial.,"OBJECTIVE


To evaluate fasting for 12 hours compared with expedited oral feeding in hospitalised women with hyperemesis gravidarum (HG).
DESIGN


Randomised trial.
SETTING


University Hospital, Malaysia: April 2016-April 2017.
POPULATION


One hundred and sixty women hospitalised for HG.
METHOD


Women were randomised upon admission to fasting for 12 hours or expedited oral feeding. Standard HG care was instituted.
MAIN OUTCOME MEASURE


Primary outcome was satisfaction score with overall treatment at 24 hours (0-10 Visual Numerical Rating Scale VNRS), vomiting episodes within 24 hours and nausea VNRS score at enrolment, and at 8, 16 and 24 hours.
RESULTS


Satisfaction score, median (interquartile range) 8 (5-9) versus 8 (7-9) (P = 0.08) and 24-hour vomiting episodes were 1 (0-4) versus 1 (0-5) (P = 0.24) for 12-hour fasting versus expedited feeding, respectively. Repeated measures analysis of variance of nausea scores over 24 hours showed no difference (P = 0.11) between trial arms. Participants randomised to 12-hour fasting compared with expedited feeding were less likely to prefer their feeding regimen in future hospitalisation (41% versus 65%, P = 0.001), to recommend to a friend (65% versus 84%, P = 0.01; RR 0.8, 95% CI 0.6-0.9) and to adhere to protocol (85% versus 95%, P = 0.04; RR 0.9, 95% CI 0.8-1.0). Symptoms profile, ketonuria status at 24 hours and length of hospital stay were not different.
CONCLUSION


Advisory of 12-hour fasting compared with immediate oral feeding resulted in a non-significant difference in satisfaction score but adherence to protocol and fidelity to and recommendation of immediate oral feeding to a friend were lower. The 24-hour nausea scores and vomiting episodes were similar.
TWEETABLE ABSTRACT


Women hospitalised for hyperemesis gravidarum could feed as soon, as much and as often as can be tolerated compared with initial fasting.",2020,"Participants randomised to 12-hours fasting compared to expedited feeding were less likely to prefer their feeding regimen in future hospitalisation 41% vs 65% P=0.001, to recommend to a friend 65% vs 84% P=0.01 (RR 0.8 95% CI 0.6-0.9) and to adhere to protocol 85% vs 95% P=0.04 (RR 0.9 95% CI 0.8-1.0).","['hospitalised hyperemesis gravidarum (HG) DESIGN', '160 women hospitalised for hyperemesis gravidarum (HG) METHOD', 'University Hospital, Malaysia: April 2016-April']",[],"['24-hour vomiting episodes', 'nausea scores', 'satisfaction score', '24-hour nausea scores and vomiting episodes', 'satisfaction score with overall treatment at 24 hours (0-10 Visual Numerical Rating Scale VNRS), vomiting episodes within 24 hours and nausea VNRS score', 'Symptoms profile, ketonuria status at 24 hours and length of hospital stay']","[{'cui': 'C0020450', 'cui_str': 'Hyperemesis gravidarum'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]",[],"[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162275', 'cui_str': 'Ketonuria'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.218001,"Participants randomised to 12-hours fasting compared to expedited feeding were less likely to prefer their feeding regimen in future hospitalisation 41% vs 65% P=0.001, to recommend to a friend 65% vs 84% P=0.01 (RR 0.8 95% CI 0.6-0.9) and to adhere to protocol 85% vs 95% P=0.04 (RR 0.9 95% CI 0.8-1.0).","[{'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Abdussyukur', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'B K', 'Initials': 'BK', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Win', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S Z', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16290']
19,32367416,Impact of spectral body imaging in patients suspected for occult cancer: a prospective study of 503 patients.,"OBJECTIVES


To investigate the diagnostic impact and performance of spectral dual-layer detector CT in the detection and characterization of cancer compared to conventional CE-CT.
METHODS


In a national workup program for occult cancer, 503 patients (286 females and 217 males) were prospectively enrolled for a contrast-enhanced spectral CT scan. The readings were performed with and without spectral data available. A minimum of 3 months between interpretations was implemented to minimize recall bias. The sequence of reads for the individual patient was randomized. Readers were blinded for patient identifiers and clinical outcome. Two radiologists with 9 and 33 years of experience performed the readings in consensus. If disagreement, a third radiologist with 11 years of experience determined the outcome of the reading RESULTS: Significantly more cancer findings were identified on the spectral reading. In 73 cases of proven cancer, we found a sensitivity of 89% vs 77% and a specificity of 77% vs 83% on spectral CT compared to conventional CT. A slight increase in reading time in spectral images of 82 s was found (382 vs 300, p < 0.001). For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries. And adding the spectral information to the reading gave a decrease in follow-up examination for diagnostic certainty (0.25 vs 0.81 per reading, p < 0.001).
CONCLUSION


The use of contrast-enhanced spectral CT increases the confidence of the radiologists in correct characterization of various lesions and minimizes the need for supplementary examinations.
KEY POINTS


• Spectral CT is associated with a higher sensitivity, but a slightly lower specificity compared to conventional CT. • Spectral CT increases the confidence of the radiologists. • The need for supplementary examinations is decreased, with only a slight increase in reading times.",2020,"For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries.","['503 patients', '503 patients (286 females and 217 males', 'patients suspected for occult cancer']","['contrast-enhanced spectral CT', 'spectral dual-layer detector CT', 'spectral body imaging']","['diagnostic certainty', 'reading time in spectral images', 'reading times']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",503.0,0.0300193,"For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries.","[{'ForeName': 'Michael Brun', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Herlev and Gentofte, Gentofte Hospitalsvej 1, 2900, Hellerup, Denmark. Michael.brun.andersen@regionh.dk.'}, {'ForeName': 'Dyveke', 'Initials': 'D', 'LastName': 'Ebbesen', 'Affiliation': 'Department of Radiology, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, Aarhus, 8200, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Thygesen', 'Affiliation': 'Department of Clinical Engineering, Central Denmark Region, Nørrebrogade 44, Building 2A, Aarhus, 8000, Denmark.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kruis', 'Affiliation': 'Philips Medical Systems, Clinical Science, CT, Veenpluis 4-6, Best, 5684, The Netherlands.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Radiology, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, Aarhus, 8200, Denmark.'}]",European radiology,['10.1007/s00330-020-06878-7']
20,32358477,"Impact of the Fascia Iliaca Block on Pain, Opioid Consumption, and Ambulation for Patients With Hip Fractures: A Prospective, Randomized Study.","OBJECTIVES


To determine the effect of the fascia iliaca block (FIB) on patients undergoing surgery for hip fractures.
DESIGN


Prospective, randomized controlled trial.
SETTING


Level I trauma center.
PATIENTS/PARTICIPANTS


Patients (N = 97) undergoing surgery for hip fractures were prospectively randomized to receive either a perioperative FIB (FIB group) or no block (control group) from February 2018 to April 2019.
MAIN OUTCOME MEASURES


Visual analog scale (VAS) score, morphine milligram equivalents, and postoperative ambulatory distance.
RESULTS


Fifty-seven patients were randomized to the FIB group, and 40 patients were randomized to the control group. Eighteen patients crossed over from the FIB to the control group, and 12 patients crossed over from the control to the FIB group. In the intent-to-treat analysis, demographic data, mechanism of injury, radiographic fracture classification, and surgical procedure were similar between the 2 groups. The FIB group consumed fewer morphine milligram equivalents before surgery (13 vs. 17, P = 0.04), had a trend toward an improved visual analog scale score on postoperative day 2 (0 vs. 2 P = 0.06), and walked a farther distance on postoperative day 2 (25' vs. 2', P = 0.09). A greater proportion of the FIB group were discharged home (50.9% vs. 32.5%, P = 0.05). There were no differences in opioid-related, block-related, or medical complications between groups. In the as-treated and per-protocol analyses, there were no significant differences.
CONCLUSIONS


A single perioperative FIB for patients with hip fractures undergoing surgery may decrease opioid consumption and increase the likelihood that a patient is discharged home.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"The FIB group consumed fewer MMEs prior to surgery (13 versus 17, p = 0.04), had a trend toward improved VAS on postop day (POD) 2 (0 versus 2 p = 0.06), and walked a farther distance POD 2 (25' versus 2 ' p = 0.09).","['group) from February 2018 to April 2019', 'patients undergoing surgery for hip fractures', 'Patients (N = 97) undergoing surgery for hip fractures', 'patients with hip fractures undergoing surgery', 'patients with hip fractures']","['perioperative FIB (FIB group) or receive no block (control', 'fascia iliaca block', 'fascia iliaca block (FIB']","['MMEs prior to surgery', 'pain, opioid consumption, and ambulation', 'visual analog score (VAS), morphine milligram equivalents (MME), post-operative ambulatory distance', 'opioid consumption', 'opioid-related, block-related, or medical complications']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0066662', 'cui_str': '1,2,3,4,9,9-hexachloro-1,4,4a,5,8,8a-hexahydro-6- methyl-6,7-epoxy-1,4-methanonaphthalene'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",97.0,0.0662857,"The FIB group consumed fewer MMEs prior to surgery (13 versus 17, p = 0.04), had a trend toward improved VAS on postop day (POD) 2 (0 versus 2 p = 0.06), and walked a farther distance POD 2 (25' versus 2 ' p = 0.09).","[{'ForeName': 'Spencer S', 'Initials': 'SS', 'LastName': 'Schulte', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Fernandez', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Van Tienderen', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Reich', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Adler', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}, {'ForeName': 'Mai P', 'Initials': 'MP', 'LastName': 'Nguyen', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, Texas Tech University Health Sciences Center El Paso, El Paso, TX.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001795']
21,32357096,Diving into the Details: Constructing a Framework of Random Call Components.,"Random call is a randomized approach to select a student or group of students to share their thinking with the whole class. There are potential costs and benefits of random call in undergraduate courses, yet we lack insight about how this strategy is actually implemented and why instructors choose to use it. We interviewed 12 college biology instructors who use random call in courses with 50 or more students. Qualitative content analysis revealed why these instructors chose to use random call, the specific ways they implemented random call, and the reasoning behind their implementation. Instructors used random call to increase the diversity of voices heard in the classroom and to hold students accountable for working. Random call users showed concern about student anxiety and took specific steps to mitigate it. We break random call down into a series of components, identify the components that our participants considered most critical, and describe the reasoning underlying random call components. This work lays a foundation for future investigations of how specific random call components influence student outcomes, in what contexts, and for which students.",2020,"Qualitative content analysis revealed why these instructors chose to use random call, the specific ways they implemented random call, and the reasoning behind their implementation.",['12 college biology instructors who use random call in courses with 50 or more students'],[],[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0005532', 'cui_str': 'Biology'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],[],12.0,0.0228881,"Qualitative content analysis revealed why these instructors chose to use random call, the specific ways they implemented random call, and the reasoning behind their implementation.","[{'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Waugh', 'Affiliation': 'Department of Genetics, University of Georgia, Athens, GA 30602.'}, {'ForeName': 'Tessa C', 'Initials': 'TC', 'LastName': 'Andrews', 'Affiliation': 'Department of Genetics, University of Georgia, Athens, GA 30602.'}]",CBE life sciences education,['10.1187/cbe.19-07-0130']
22,32295726,An age-adjusted instruction video enhances the correct use of nasal corticosteroid sprays in children.,"INTRODUCTION AND OBJECTIVES


Allergic rhinitis is a common disorder. Intranasal corticosteroid sprays are used to control symptoms. However, incorrect use of these sprays can decrease efficacy and lead to side effects such as nose bleeding. We studied if watching an age-adjusted instruction video is effective to improve administration technique.
MATERIALS AND METHODS


We invited children who used intranasal corticosteroid sprays. We examined their administration technique before, directly after, and one month after showing them an age-adjusted instruction video. We compared their administration technique with the instructions in the patient information leaflet. We assessed whether the children performed the seventeen maneuvers mentioned in the patient information leaflet and the eight we considered essential.
RESULTS


Of the 99 eligible children, 23 (15 boys, median age nine years) participated. Before watching the instruction video none of them administered according to all maneuvers in the patient information leaflet or showed all essential maneuvers. One month after seeing the instruction video, three children demonstrated correct inhalation as per the patient information leaflet. Three performed the essential maneuvers. When a 75% threshold level for carrying out all 17 maneuvers was used, still none showed 75% of all or of the essential maneuvers before watching the video. Yet, after one month 12 children showed sufficient administration technique (52%, 95% confidence interval (CI) 31%-73%, p = 0.004). Nine showed all essential manoeuvres (47%, 95%CI 24%-71%, p = 0.004).
CONCLUSIONS


An age-adjusted instruction video is a useful and easy method to teach children to administer nasal intranasal corticosteroid sprays correctly.",2020,An age-adjusted instruction video is a useful and easy method to teach children to administer nasal intranasal corticosteroid sprays correctly.,"['children', '99 eligible children, 23 (15 boys, median age nine years) participated', 'We invited children who used']","['intranasal corticosteroid sprays', 'Intranasal corticosteroid sprays']",['sufficient administration technique'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",99.0,0.0599585,An age-adjusted instruction video is a useful and easy method to teach children to administer nasal intranasal corticosteroid sprays correctly.,"[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Ter Laak', 'Affiliation': 'Department of Pediatrics, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lucas', 'Affiliation': 'Department of Pediatrics, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Juliët', 'Initials': 'J', 'LastName': 'Oude Nijeweeme', 'Affiliation': 'Department of Pediatrics, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'van Ravenstein', 'Affiliation': 'Department of Pediatrics, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'de Jong', 'Affiliation': 'Department of Epidemiology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Rollema', 'Affiliation': 'Department of Pediatrics, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Tjalling', 'Initials': 'T', 'LastName': 'de Vries', 'Affiliation': 'Department of Pediatrics, Medical Centre Leeuwarden, Leeuwarden, The Netherlands. Electronic address: tjalling.de.vries@znb.nl.'}]",Allergologia et immunopathologia,['10.1016/j.aller.2019.11.006']
23,32355123,Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial.,"INTRODUCTION


Chronic hepatitis B (CHB) remains a major worldwide public health concern. Besifovir dipivoxil maleate (BSV) is a new promising treatment for CHB. However, long-term efficacy and safety have not yet been evaluated. Therefore, the goal of the study is to determine the antiviral efficacy and safety of BSV treatment over a 144-week duration (BSV-BSV) in comparison with those of a sequential treatment with tenofovir disoproxil fumarate (TDF) followed by a 96-week duration BSV administration (TDF-BSV).
METHODS


After 48 weeks of a double-blind comparison between BSV and TDF treatments, patients continued the open-label BSV study. We evaluated antiviral efficacy and drug safety up to 144 weeks for BSV-BSV and TDF-BSV groups. The primary endpoint was a virological response (hepatitis B virus DNA < 69 IU/mL).
RESULTS


Among the 197 patients enrolled, 170 and 158 patients entered the second-year and third-year open-label phase extensional study, respectively, whereas 153 patients completed the 144-week follow-up. The virological response rate over the 144-week period was 87.7% and 92.1% in BSV-BSV and TDF-BSV groups, respectively (P = 0.36). The rates of ALT normalization and HBeAg seroconversion were similar between the groups. No drug-resistant mutations to BSV were noted. Bone mineral density and renal function were well preserved in the BSV-BSV group and were significantly improved after switching therapy in TDF-BSV patients.
DISCUSSION


This extensional study of a phase 3 trial (NCT01937806) suggests that BSV treatment is efficacious and safe for long-term use in treatment-naïve and TDF-experienced patients with CHB.",2020,"Bone mineral density and renal function were well preserved in the BSV-BSV group and were significantly improved after switching therapy in TDF-BSV patients.
","['Chronic Hepatitis B', '197 patients enrolled, 170 and 158 patients entered the second-year and third-year open-label phase extensional study, respectively, whereas 153 patients completed the 144-week follow-up', 'TDF-BSV patients']","['Besifovir dipivoxil maleate (BSV', 'tenofovir disoproxil fumarate (TDF', 'BSV', 'Besifovir Dipivoxil Maleate 144-Week', 'BSV and TDF']","['rates of ALT normalization and HBeAg seroconversion', 'virological response (hepatitis B virus DNA', 'antiviral efficacy and drug safety', 'Bone mineral density and renal function', 'antiviral efficacy and safety', 'virological response rate']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4080032', 'cui_str': 'besifovir'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}]","[{'cui': 'C4080032', 'cui_str': 'besifovir'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",197.0,0.0320824,"Bone mineral density and renal function were well preserved in the BSV-BSV group and were significantly improved after switching therapy in TDF-BSV patients.
","[{'ForeName': 'Hyung Joon', 'Initials': 'HJ', 'LastName': 'Yim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul Metropolitan Government Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Mo', 'Initials': 'JM', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Catholic University Medical College St. Vincent, Suwon, Korea.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Soonchunhyang University, Seoul, Korea.'}, {'ForeName': 'Yong Oh', 'Initials': 'YO', 'LastName': 'Kweon', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Korea.'}, {'ForeName': 'Yong Kyun', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Gun Young', 'Initials': 'GY', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Kwangju Christian Hospital, Gwangju, Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Young Kul', 'Initials': 'YK', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Soon Ho', 'Initials': 'SH', 'LastName': 'Um', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Woo', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Paik Hospital, Inje University, Busan, Korea.'}, {'ForeName': 'Byung Seok', 'Initials': 'BS', 'LastName': 'Lee', 'Affiliation': 'Department of Gastroenterology and Hepatology, Chungnam National University School of Medicine, Daejeon, Korea.'}, {'ForeName': 'Ju Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gacheon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Hong Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Seung Kew', 'Initials': 'SK', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Moon Young', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'Kwan Sik', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Suk', 'Initials': 'YS', 'LastName': 'Lim', 'Affiliation': 'Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Wan Sik', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chonnam University Medical School, Gwangju, Korea.'}, {'ForeName': 'Kwang-Hyub', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000605']
24,32358638,Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve Attenuates the Acute Inflammatory Response After Lung Lobectomy.,"OBJECTIVES


Systemic inflammation is a potentially debilitating complication of thoracic surgeries with significant physical and economic morbidity. There is compelling evidence for the role of the central nervous system in regulating inflammatory processes through humoral mechanisms. Activation of the afferent vagus nerve by cytokines triggers anti-inflammatory responses. Peripheral electrical stimulation of the vagus nerve in vivo during lethal endotoxemia in rats inhibited tumor necrosis factor synthesis and prevented shock development. However, the vagal regulatory role of systemic inflammation after lung lobectomy is unknown.
METHODS


One hundred patients who underwent lobectomy via thoracotomy were recruited and equally randomized to treated group or controls. Intermittent stimulation of the auricular branch of vagus nerve in the triangular fossa was applied in the treated group using neurostimulator V (Ducest ® , Germany), starting 24 h preoperatively and continued till the 4th postoperative day (POD). Inflammatory interleukins (IL) were analyzed using ELISA preoperatively, on the 1st and 4th POD.
RESULTS


On the 1st POD, patients who underwent neurostimulation had reduced serum concentrations of CRP (p = 0.01), IL6 (p = 0.02) but elevated IL10 (p = 0.03) versus controls. On the 4th POD, serum concentrations of CRP, IL6 and IL10 were similar in both groups. Moreover, the treated group was associated with lower incidence of pneumonia (p = 0.04) and shorter hospitalization time (p = 0.04) versus controls.
CONCLUSIONS


Modulations in the brain stem caused by noninvasive transcutaneous stimulation of the vagus nerve after lung lobectomy attenuate the acute postsurgical inflammatory response by the regulation of IL6 and IL10, resulting in  reduced incidence of postoperative pneumonia and short hospitalization time.
CLINICAL TRIAL REGISTRY NUMBER


NCT03204968.",2020,"On the 1st POD, patients who underwent neurostimulation had reduced serum concentrations of CRP (p = 0.01), IL6 (p = 0.02) but elevated IL10 (p = 0.03) versus controls.",['One hundred patients who underwent'],['lobectomy via thoracotomy'],"['serum concentrations of CRP, IL6 and IL10', 'lower incidence of pneumonia', 'Inflammatory interleukins (IL', 'serum concentrations of CRP', 'shorter hospitalization time', 'Acute Inflammatory Response']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",100.0,0.0448228,"On the 1st POD, patients who underwent neurostimulation had reduced serum concentrations of CRP (p = 0.01), IL6 (p = 0.02) but elevated IL10 (p = 0.03) versus controls.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Salama', 'Affiliation': 'Department of Thoracic Surgery, North Clinic, Bruennerstrasse 68, 1210, Vienna, Austria.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Akan', 'Affiliation': 'Department of Thoracic Surgery, North Clinic, Bruennerstrasse 68, 1210, Vienna, Austria.'}, {'ForeName': 'Michael Rolf', 'Initials': 'MR', 'LastName': 'Mueller', 'Affiliation': 'Department of Thoracic Surgery, North Clinic, Bruennerstrasse 68, 1210, Vienna, Austria. michael.rolf.mueller@wienkav.at.'}]",World journal of surgery,['10.1007/s00268-020-05543-w']
25,32369102,Overlap Weighting: A Propensity Score Method That Mimics Attributes of a Randomized Clinical Trial.,,2020,,[],[],[],[],[],[],,0.167188,,"[{'ForeName': 'Laine E', 'Initials': 'LE', 'LastName': 'Thomas', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Pencina', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}]",JAMA,['10.1001/jama.2020.7819']
26,32359688,Back to the future-Are we ready for a randomized trial of surgical versus percutaneous revascularization in cardiogenic shock?,,2020,,[],['percutaneous revascularization'],[],[],"[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",[],,0.0411241,,"[{'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University, Durham, NC. Electronic address: jason.katz@duke.edu.'}]",American heart journal,['10.1016/j.ahj.2020.03.006']
27,32361698,"Effect of Sixteen Weeks Combined Training on FGF-23, Klotho, and Fetuin-A Levels in Patients on Maintenance Hemodialysis.","INTRODUCTION


Fibroblast growth factor 23 (FGF-23) and its cofactor alfa klotho, are one of the most important factors, directly and indirectly, involved in the process of calcification and atherosclerosis. This study aimed to evaluate the efficacy of a combination of regular exercise during dialysis on quality of life and markers including FGF-23, alfa klotho, and fetuin-A levels.
METHODS


Forty-five hemodialysis patients aged 61 ± 9.02 years and weight 69 ± 11.25 kg were randomly divided into two training, EX (n = 24) and control groups, CON (n = 21). The EX group patients participated in a 16-week combined aerobic and resistance exercise program during dialysis. Bone markers including, FGF-23, klotho, fetuin-A, were measured before and at the end of the study in both groups. Statistical analysis for comparing data change during study by SPSS software and the P value was set at .05.
RESULTS


In the control group in the secondary assessment, reduction in quality of life was observed (P < .05). Significant change in growth factor 23, CRP, and fetuin-A was not observed in exercise and control groups (P > .05), however significant rising of klotho was observed in treated patients (P < .05). Also, combined training reduced the amount of phosphorus, parathyroid hormone; significantly (P < .05).
CONCLUSION


This study showed that regular exercise during dialysis improves quality of life and physical functions. No significant change in FGF-23 and CRP were observed during the study. However significant rising of klotho and reduction of iPTH and phosphorous levels were observed in treated patients.",2020,"Also, combined training reduced the amount of phosphorus, parathyroid hormone; significantly (P < .05).
","['Forty-five hemodialysis patients aged 61 ± 9.02 years and weight 69 ± 11.25 kg', 'Patients on Maintenance Hemodialysis']","['regular exercise', 'combined aerobic and resistance exercise program during dialysis', 'regular exercise during dialysis', 'EX']","['quality of life', 'FGF-23, Klotho, and Fetuin-A Levels', 'amount of phosphorus, parathyroid hormone', 'FGF-23 and CRP', 'rising of klotho', 'iPTH and phosphorous levels', 'quality of life and markers including FGF-23, alfa klotho, and fetuin-A levels', 'quality of life and physical functions', 'growth factor 23, CRP, and fetuin-A']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517532', 'cui_str': '11.25'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}, {'cui': 'C0051477', 'cui_str': 'Alpha>2< hS glycoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0047008', 'cui_str': ""3,4-O-isopropylidene-3,3',4,5'-tetrahydroxystilbene""}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}]",45.0,0.013129,"Also, combined training reduced the amount of phosphorus, parathyroid hormone; significantly (P < .05).
","[{'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Fakhrpour', 'Affiliation': ''}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Hamid Tayebi Khosroshahi', 'Affiliation': 'Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. drtayebikh@yahoo.com.'}, {'ForeName': 'Khosro', 'Initials': 'K', 'LastName': 'Ebrahim', 'Affiliation': ''}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Ahmadizad', 'Affiliation': ''}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Abbasnejad', 'Affiliation': ''}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Mesgari Abbasi', 'Affiliation': ''}, {'ForeName': 'Allahverdi', 'Initials': 'A', 'LastName': 'Ghanbari', 'Affiliation': ''}, {'ForeName': 'Seyyed Fatemeh', 'Initials': 'SF', 'LastName': 'Yaghoobi', 'Affiliation': ''}]",Iranian journal of kidney diseases,[]
28,32366866,The Effects of Presleep Slow Breathing and Music Listening on Polysomnographic Sleep Measures - a pilot trial.,"Knowledge on efficient ways to reduce presleep arousal and, therefore, improve sleep, is scanty. We explored the effects of presleep slow breathing and music listening conditions on sleep quality and EEG power spectral density in young adults in a randomized, controlled trial with a crossover design. Participants' (N = 20, 50% females) sleep was measured on two consecutive nights with polysomnography (40 nights), the other night serving as the control condition. The intervention condition was either a 30-minute slow breathing exercise or music listening (music by Max Richter: Sleep). The intervention and control conditions were placed in a random order. We measured heart rate variability prior to, during and after the intervention condition, and found that both interventions increased immediate heart rate variability. Music listening resulted in decreased N2 sleep, increased frontal beta1 power spectral density, and a trend towards increased N3 sleep was detected. In the slow breathing condition higher central delta power during N3 was observed. While some indices pointed to improved sleep quality in both intervention groups, neither condition had robust effects on sleep quality. These explorative findings warrant further replication in different populations.",2020,"Music listening resulted in decreased N2 sleep, increased frontal beta1 power spectral density, and a trend towards increased N3 sleep was detected.","[""Participants' (N\u2009=\u200920, 50% females) sleep was measured on two consecutive nights with polysomnography (40 nights), the other night serving as the control condition"", 'young adults']","['presleep slow breathing and music listening conditions', 'slow breathing exercise or music listening (music by Max Richter: Sleep', 'Music listening', 'Presleep Slow Breathing and Music Listening']","['N3 sleep', 'immediate heart rate variability', 'N2 sleep, increased frontal beta1 power spectral density', 'heart rate variability', 'sleep quality', 'sleep quality and EEG power spectral density']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0231837', 'cui_str': 'Slow respiration'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C4704917', 'cui_str': 'NREM Stage 2'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",,0.0350024,"Music listening resulted in decreased N2 sleep, increased frontal beta1 power spectral density, and a trend towards increased N3 sleep was detected.","[{'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Kuula', 'Affiliation': 'SleepWell Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland. liisa.kuula-paavola@helsinki.fi.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Halonen', 'Affiliation': 'SleepWell Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Kajanto', 'Affiliation': 'SleepWell Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Lipsanen', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Makkonen', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Miina', 'Initials': 'M', 'LastName': 'Peltonen', 'Affiliation': 'Department of oral and maxillofacial diseases, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anu-Katriina', 'Initials': 'AK', 'LastName': 'Pesonen', 'Affiliation': 'SleepWell Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}]",Scientific reports,['10.1038/s41598-020-64218-7']
29,32361977,"Safety, Tolerability and Pharmacokinetics of Vidofludimus calcium (IMU-838) After Single and Multiple Ascending Oral Doses in Healthy Male Subjects.","BACKGROUND AND OBJECTIVE


Vidofludimus is a potent and selective inhibitor of human mitochondrial enzyme dihydroorotate dehydrogenase (DHODH). The clinical efficacy and safety profile of vidofludimus has been analyzed in patients suffering from rheumatoid arthritis and Crohn's disease and ulcerative colitis. In previous sudies, hematuria at higher doses occurred in close temporal relationship to vidofludimus administration and appeared to be dose related. The present report describes the results from two phase 1 studies conducted in healthy male subjects to investigate the safety, tolerability and pharmacokinetics after single and multiple ascending (SAD and MAD) oral doses of IMU-838 (vidofludimus calcium, tablets containing a specific polymorph). The effect of food on the pharmacokinetics of IMU-838 was also assessed in the SAD study.
METHODS


In the SAD study, 12 subjects received single doses of IMU-838 under fasting (10-40 mg) or fed (10 mg) condition in an open-label, partial parallel group design. In the MAD study, 52 subjects received multiple doses of IMU-838 (30-50 mg) in a double-blind, placebo-controlled, parallel group design.
RESULTS


IMU-838 showed dose-proportional pharmacokinetics after single and multiple oral dosing in both SAD and MAD studies. IMU-838 was well absorbed after single daily doses. Food did not impact the pharmacokinetics of IMU-838. The accumulation factor for multiple daily dosing was approximately 2. Steady-state concentrations were reached within about 6-8 days for 30-50 mg groups. The geometric mean plasma half-life of IMU-838 at steady state was approximately 30 h, which supports its use for once-daily dosing regimen. Single and multiple oral doses of IMU-838 were safe and well tolerated.
CONCLUSION


Overall, oral IMU-838 was generally well tolerated in SAD and MAD studies in healthy subjects over a wide dose range of 10-50 mg. IMU-838 was well absorbed after single daily doses. IMU-838 showed dose proportional pharmacokinetics after single and multiple oral dosing.",2020,Food did not impact the pharmacokinetics of IMU-838.,"['healthy subjects', 'healthy male subjects', ""patients suffering from rheumatoid arthritis and Crohn's disease and ulcerative colitis"", 'Healthy Male Subjects']","['IMU-838 under fasting (10-40\xa0mg) or fed (10\xa0mg) condition in an open-label, partial parallel group design', 'IMU-838 (vidofludimus calcium, tablets containing a specific polymorph', 'IMU-838', 'vidofludimus', 'Vidofludimus calcium (IMU-838', 'placebo']","['safe and well tolerated', 'Steady-state concentrations', 'safety, tolerability and pharmacokinetics', 'Safety, Tolerability and Pharmacokinetics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0270602', 'cui_str': 'Latah'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C2974101', 'cui_str': 'vidofludimus'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",52.0,0.0440893,Food did not impact the pharmacokinetics of IMU-838.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Muehler', 'Affiliation': 'Immunic AG, Am Klopferspitz 19, 82152, Planegg-Martinsried, Germany. andreas.muehler@imux.com.'}, {'ForeName': 'Hella', 'Initials': 'H', 'LastName': 'Kohlhof', 'Affiliation': 'Immunic AG, Am Klopferspitz 19, 82152, Planegg-Martinsried, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Groeppel', 'Affiliation': 'Immunic AG, Am Klopferspitz 19, 82152, Planegg-Martinsried, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vitt', 'Affiliation': 'Immunic AG, Am Klopferspitz 19, 82152, Planegg-Martinsried, Germany.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00623-7']
30,32366577,The Influence of Baseline Diastolic Blood Pressure on the Effects of Intensive Blood Pressure Lowering on Cardiovascular Outcomes and All-Cause Mortality in Type 2 Diabetes.,"OBJECTIVE


To examine whether low baseline diastolic blood pressure (DBP) modifies the effects of intensive systolic blood pressure (SBP) lowering on cardiovascular outcomes in type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS


The Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial (ACCORD BP), a two-by-two factorial randomized controlled trial, examined effects of SBP (<120 vs. <140 mmHg) and glycemic (HbA 1c  <6% vs. 7.0-7.9% [<42 vs. 53-63 mmol/mol]) control on cardiovascular events in T2DM ( N  = 4,731). We examined whether effects of SBP control on cardiovascular composite were modified by baseline DBP and glycemic control.
RESULTS


Intensive SBP lowering decreased the risk of the cardiovascular composite (hazard ratio [HR] 0.76 [95% CI 0.59-0.98]) in the standard glycemic arm but not in the intensive glycemic arm (HR 1.06 [95% CI 0.81-1.40]). Spline regression models relating the effects of the intervention on the cardiovascular composite across the range of baseline DBP did not show evidence of effect modification by low baseline DBP for the cardiovascular composite in the standard or intensive glycemic arms. The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction ( P  = 0.83).
CONCLUSIONS


In persons with T2DM, intensive SBP lowering decreased the risk of cardiovascular composite end point irrespective of baseline DBP in the setting of standard glycemic control. Hence, low baseline DBP should not be an impediment to intensive SBP lowering in patients with T2DM treated with guideline-recommended standard glycemic control.",2020,"The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction ( P  = 0.83).
","['Type 2 Diabetes', 'type 2 diabetes mellitus (T2DM']","['low baseline diastolic blood pressure (DBP', 'Intensive Blood Pressure Lowering', 'intensive SBP intervention', 'intensive systolic blood pressure (SBP) lowering', 'SBP control', 'SBP']","['cardiovascular events', 'risk of the cardiovascular composite (hazard ratio [HR', 'risk of cardiovascular composite', 'cardiovascular outcomes']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4274392', 'cui_str': 'Baseline diastolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0567952,"The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction ( P  = 0.83).
","[{'ForeName': 'Olesya L', 'Initials': 'OL', 'LastName': 'Ilkun', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Division of Biostatistics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Boucher', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Beddhu', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, UT srinivasan.beddhu@hsc.utah.edu.'}]",Diabetes care,['10.2337/dc19-2047']
31,32362377,Effective self-stretching of carpal ligament for the treatment of carpal tunnel syndrome: A double-blinded randomized controlled study.,"INTRODUCTION


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


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


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


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


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


The myofascial stretching of the carpal ligament showed statistically significant symptom improvement in persons with CTS. Larger comparative studies that include other modalities such as splinting should be performed to confirm the effectiveness of this treatment option.",2020,"Even though the ANOVA analyses were inconclusive about group differences, explorative post hoc analyses revealed significant improvements in numbness (P = .011, Cohen's d = .53), tingling (P = .007, Cohen's d = .60), pinch strength (P = .007, Cohen's d = -.58), and symptom severity scale (P = .007, Cohen's d = .69) for the treatment group only.
","['carpal tunnel syndrome', 'Seventeen participants in the sham treatment group and 19 participants in the carpal ligament stretching group completed the study', 'persons with CTS', 'Eighty-three participants diagnosed with median mononeuropathy across the wrist by nerve conduction study']","['self-myofascial stretching', 'carpal ligament', 'carpal ligament stretching', 'sham treatment or self-carpal ligament stretching', 'placebo']","['pinch strength', 'tingling', 'symptom severity scale', 'numbness', 'subjective complaints, strength, nerve conduction findings, and functional scores']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007285', 'cui_str': 'Bone structure of carpus'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751922', 'cui_str': 'Median neuropathy'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0007285', 'cui_str': 'Bone structure of carpus'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C1286635', 'cui_str': 'Nerve conduction - finding'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",83.0,0.0616565,"Even though the ANOVA analyses were inconclusive about group differences, explorative post hoc analyses revealed significant improvements in numbness (P = .011, Cohen's d = .53), tingling (P = .007, Cohen's d = .60), pinch strength (P = .007, Cohen's d = -.58), and symptom severity scale (P = .007, Cohen's d = .69) for the treatment group only.
","[{'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Shem', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Santa Clara Valley Medical Center, San Jose, CA, USA. Electronic address: kazuko.shem@hhs.sccgov.org.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Dirlikov', 'Affiliation': 'Rehabilitation Research Center, Santa Clara Valley Medical Center, San Jose, CA, USA.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.12.002']
32,32369630,In situ decompression vs conservative treatment for mild ulnar neuropathy at the elbow.,"INTRODUCTION


The best treatment strategy for mild ulnar neuropathy at the elbow (UNE) is not known, due to lack of trials comparing surgery vs conservative treatment.
METHODS


We recruited patients with clinical symptoms and signs of mild UNE and an electrophysiologically or sonographically confirmed diagnosis. Patients were randomly allocated to either in situ decompression or conservative treatment. The primary outcome was the proportion of patients with subjective symptom improvement at short-term (3 months) and long-term (6-12 months) follow-up.
RESULTS


One hundred seventeen patients were included: 56 and 61 patients were allocated to surgery and conservative treatment, respectively. A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% vs 50%; odds ratio, 5.6; P < .001), but no differences were observed at long-term follow-up.
DISCUSSION


In situ decompression for mild UNE may result in faster relief of symptoms when compared with conservative treatment, but at long-term follow-up no differences were observed.",2020,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up.
","['Patients with clinical symptoms and signs of mild UNE and an electrophysiologically or sonographically confirmed diagnosis were recruited', '117 patients were included: 56 and 61 patients']","['situ decompression or conservative treatment', 'situ decompression versus conservative treatment']","['relief of symptoms', 'proportion of patients with subjective symptom improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",117.0,0.0474031,"A larger proportion of surgically treated patients showed improvement at short-term follow-up (85% versus 50%, odds ratio 5.6, p <.001), but no differences were observed at long-term follow-up.
","[{'ForeName': 'Sander M', 'Initials': 'SM', 'LastName': 'Pompe', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Tobien', 'Initials': 'T', 'LastName': 'Schreuder', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Laurien L', 'Initials': 'LL', 'LastName': 'Teunissen', 'Affiliation': 'Department of Neurology, St. Antonius Ziekenhuis Nieuwegein, The Netherlands.'}, {'ForeName': 'Leo H', 'Initials': 'LH', 'LastName': 'Visser', 'Affiliation': 'Department of Neurology, Elisabeth TweeSteden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Beekman', 'Affiliation': 'Department of Neurology, Zuyderland Medisch Centrum, Sittard-Geleen, The Netherlands.'}]",Muscle & nerve,['10.1002/mus.26912']
33,32379066,"Outcomes of different minimally invasive techniques in lower calyceal stones of 1 to 2 centimeters: A prospective, randomized study.","OBJECTIVE


To compare efficiency, safety and full cost of lower retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) types for the treatment of lower calyceal stones between 1 and 2 cm in size.
METHODS


This was a prospective, randomized study. In all, 175 patients were randomly divided into five groups of 35 patients each: Group A was managed by RIRS, Group B by micro PNL, Group C by ultra-mini PNL, Group D by mini PNL, and Group E by standard PNL. Operating and fluoroscopy time, length of hospital stay, stone-free rates (SFR), complications, secondar y ureterolithotripsy and cost were compared between groups. RESULTS: A total of 168 patients were included in the final analysis. The SFR was 76%, 77%, 90.1%, 94.1% and 94%; median length of hospital stay 1, 1.5, 2, 2, and 3 days was for RIRS, micro, ultra-mini, mini, and standard PNL, respectively (p<0.001). The mean costs of the procedures per case were $1,250, $962,$695, $632, and $619, and the mean return to daily activities time was 3.9, 4.5, 6.5, 9.3, and 13.5 days for RIRS, micro, ultra-mini, mini,and standard PNL, respectively (p<0.001).
CONCLUSIONS


SFR of treatment of lower calyceal stone was higher in ultra-mini, mini and standard PNL than micro PNL and RIRS. Moreover, patients should be informed about the results of all different procedures ; with increasing of the invasiveness of treatment, cost of the procedure decrease; but the hospital stay and return to daily activity interval increase.",2020,"Operating and fluoroscopy time, length of hospital stay, stone-free rates (SFR), complications, secondar y ureterolithotripsy and cost were compared between groups. ","['lower calyceal stones of 1 to 2 centimeters', '175 patients were randomly divided into five groups of 35 patients each', 'lower calyceal stones between 1 and 2 cm in size', 'A total of 168 patients were included in the final analysis']","['lower retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL', 'Group A was managed by RIRS, Group B by micro PNL, Group C by ultra-mini PNL, Group D by mini PNL, and Group E by standard PNL', 'minimally invasive techniques']","['hospital stay and return to daily activity interval increase', 'efficiency, safety and full cost', 'median length of hospital stay', 'Operating and fluoroscopy time, length of hospital stay, stone-free rates (SFR), complications, secondar y ureterolithotripsy and cost', 'mean\xa0costs of the procedures per case', 'mean return to daily activities time', 'SFR']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0403714', 'cui_str': 'Calyceal renal calculus'}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",175.0,0.0239209,"Operating and fluoroscopy time, length of hospital stay, stone-free rates (SFR), complications, secondar y ureterolithotripsy and cost were compared between groups. ","[{'ForeName': 'Abdulmecit', 'Initials': 'A', 'LastName': 'Yavuz', 'Affiliation': 'Urology Department. Iskenderun Gelisim Private Hospital. Istanbul. Turkey.'}, {'ForeName': 'Muhammet Fatih', 'Initials': 'MF', 'LastName': 'Kilinc', 'Affiliation': 'Urology Department. Ankara Training and Research Hospital. Ankara. Turkey.'}, {'ForeName': 'Goksel', 'Initials': 'G', 'LastName': 'Bayar', 'Affiliation': 'Urology Department. Martyr Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital. Istanbul. Turkey.'}]",Archivos espanoles de urologia,[]
34,32371401,Limit of detection of troponin discharge strategy versus usual care: randomised controlled trial.,"INTRODUCTION


The clinical effectiveness of a 'rule-out' acute coronary syndrome (ACS) strategy for emergency department patients with chest pain, incorporating a single undetectable high-sensitivity cardiac troponin (hs-cTn) taken at presentation, together with a non-ischaemic ECG, remains unknown.
METHODS


A randomised controlled trial, across eight hospitals in the UK, aimed to establish the clinical effectiveness of an undetectable hs-cTn and ECG (limit of detection and ECG discharge (LoDED)) discharge strategy. Eligible adult patients presented with chest pain; the treating clinician intended to perform investigations to rule out an ACS; the initial ECG was non-ischaemic; and peak symptoms occurred <6 hours previously. Participants were randomised 1:1 to either the LoDED strategy or the usual rule-out strategy. The primary outcome was discharge from the hospital within 4 hours of arrival, without a major adverse cardiac event (MACE) within 30 days.
RESULTS


Between June 2018 and March 2019, 632 patients were randomised; 3 were later withdrawn. Of 629 patients (age 53.8 (SD 16.1) years, 41% women), 7% had a MACE within 30 days. For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98). No patient with an initial undetectable hs-cTn had a MACE within 30 days.
CONCLUSION


The LoDED strategy facilitates safe early discharge in >40% of patients with chest pain. Clinical effectiveness is variable when compared with existing rule-out strategies and influenced by wider system factors.
TRIAL REGISTRATION NUMBER


ISRCTN86184521.",2020,"For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98).","['patients with chest pain', 'Between June 2018 and March 2019', 'Eligible adult patients presented with chest pain', 'emergency department patients with chest pain, incorporating a single undetectable high-sensitivity cardiac troponin (hs-cTn) taken at presentation, together with a non-ischaemic ECG, remains unknown', '629 patients (age 53.8 (SD 16.1) years, 41% women), 7% had a MACE within 30 days', '632 patients were randomised; 3 were later withdrawn']","['MACE', 'LoDED strategy or the usual rule-out strategy', 'troponin discharge strategy']","['clinical effectiveness of an undetectable hs-cTn and ECG (limit of detection and ECG discharge (LoDED)) discharge strategy', 'discharge from the hospital within 4\u2009hours of arrival, without a major adverse cardiac event (MACE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2718050', 'cui_str': 'Limits of Detection'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C2718050', 'cui_str': 'Limits of Detection'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",632.0,0.276477,"For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98).","[{'ForeName': 'Edward Watts', 'Initials': 'EW', 'LastName': 'Carlton', 'Affiliation': 'Emergency Department, North Bristol NHS Trust, Bristol, UK eddcarlton@gmail.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ingram', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Research Design Service South West, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Glynn', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kandiyali', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Beasant', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Aziz', 'Affiliation': 'Cardiology, North Bristol NHS Trust, Westbury on Trym, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Beresford', 'Affiliation': 'Biochemistry, North Bristol NHS Trust, Westbury on Trym, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Kendall', 'Affiliation': 'Emergency Department, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Reuben', 'Affiliation': 'Emergency Department, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Smith', 'Affiliation': 'Emergency Department, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Chapman', 'Affiliation': 'Peninsula Clinical Trials Unit, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'Centre for Medical Statistics, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Jonathan Richard', 'Initials': 'JR', 'LastName': 'Benger', 'Affiliation': 'Academic Department of Emergency care, The University Hospitals NHS Foundation trust, Bristol, UK.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2020-316692']
35,32372118,Results after the application of tranexamic acid intravenous or intra-articular in the control of postsurgical bleeding after total hip arthroplasty: a randomized controlled trial.,"INTRODUCTION


A frequent complication after total hip arthroplasty is bleeding; to reduce it, intravenous or intra-articular tranexamic acid (TXA) is used. There is no evidence yet on which route of administration is better.
MATERIALS AND METHOD


This was a prospective, controlled, randomized study in 2 arms between February 2017 and February 2019. In group A, 15 mg/kg intravenous TXA was administered and in group B 2 g intra-articular TXA. Haemoglobin and haematocrit values were evaluated at 24-72 h, also volume of drained blood, volume of blood lost, transfusions and complications.
RESULTS


A total of 195 patients were included: 110 in group A and 85 group B. Haemoglobin dropped 3.10 ± 1.32 g/dl in 24 h and 3.63 ± 1.41 g/dl at 72 h in group A; the haematocrit dropped 8.38 ± 4.67% in 24 h and 15.40 ± 4.39% in 72 h. In group B, haemoglobin dropped 3.09 ± 1.40 g/dl in 24 h and 3.34 ± 1.23 g/dl in 72 h and haematocrit 9.75 ± 3.95% and 10.40 ± 3.72% in 24 and 72 h. No significant differences were found for haemoglobin values at 24 and 72 h and haematocrit at 24 h (p > 0.05); we did not obtain statistically significant differences in drainage, blood loss between groups or in the proportion of transfused. When stratifying the results by age, we obtained significant differences in the decrease in haemoglobin (p = 0.021) and haematocrit (p = 0.025) in patients > 65 years.
CONCLUSIONS


The different routes of administration of TXA in PTC have a similar effect in reducing post-operative bleeding without evidencing an increase in complications.
LEVEL OF EVIDENCE


I.",2020,"No significant differences were found for haemoglobin values at 24 and 72 h and haematocrit at 24 h (p > 0.05); we did not obtain statistically significant differences in drainage, blood loss between groups or in the proportion of transfused.","['2 arms between February 2017 and February 2019', 'postsurgical bleeding after total hip arthroplasty', 'A total of 195 patients were included']","['tranexamic acid intravenous', 'tranexamic acid (TXA', 'TXA']","['Haemoglobin and haematocrit values', 'drainage, blood loss', 'haematocrit', 'haemoglobin', 'haemoglobin values', 'volume of drained blood, volume of blood lost, transfusions and complications']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",195.0,0.0652245,"No significant differences were found for haemoglobin values at 24 and 72 h and haematocrit at 24 h (p > 0.05); we did not obtain statistically significant differences in drainage, blood loss between groups or in the proportion of transfused.","[{'ForeName': 'María Del Sol', 'Initials': 'MDS', 'LastName': 'Gómez-Aparicio', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Doctor Peset University Hospital, Avenida Gaspar Aguilar, 90, 46017, Valencia, Spain. solgomezaparicio@gmail.com.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gómez-Barbero', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Doctor Peset University Hospital, Avenida Gaspar Aguilar, 90, 46017, Valencia, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Blas-Dobón', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Doctor Peset University Hospital, Avenida Gaspar Aguilar, 90, 46017, Valencia, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Villar-Blanco', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Doctor Peset University Hospital, Avenida Gaspar Aguilar, 90, 46017, Valencia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Morales-Suárez-Varela', 'Affiliation': 'Unit of Preventive Medicine and Public Health, Department of Preventive Medicine and Public Health, University of Valencia, Valencia, Spain.'}, {'ForeName': 'José Luís', 'Initials': 'JL', 'LastName': 'Rodrigo-Pérez', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Doctor Peset University Hospital, Avenida Gaspar Aguilar, 90, 46017, Valencia, Spain.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02688-1']
36,32384147,Impact of arginine therapy on mitochondrial function in children with sickle cell disease during vaso-occlusive pain.,"Altered mitochondrial function occurs in sickle cell disease (SCD), due in part to low nitric oxide (NO) bioavailability. Arginine, the substrate for NO production, becomes acutely deficient in SCD patients with vaso-occlusive pain episodes (VOE). To determine if arginine improves mitochondrial function, 12 children with SCD-VOE (13.6 ± 3 years; 67% male; 75% hemoglobin-SS) were randomized to 1 of 3 arginine doses: (1) 100 mg/kg IV 3 times/day (TID); (2) loading dose (200 mg/kg) then 100 mg/kg TID; or (3) loading dose (200 mg/kg) followed by continuous infusion (300 mg/kg per day) until discharge. Platelet-rich plasma mitochondrial activity, protein expression, and protein-carbonyls were measured from emergency department (ED) presentation vs discharge. All VOE subjects at ED presentation had significantly decreased complex-V activity compared to a steady-state cohort. Notably, complex-V activity was increased at discharge in subjects from all 3 arginine-dosing schemes; greatest increase occurred with a loading dose (P < .001). Although complex-IV and citrate synthase activities were similar in VOE platelets vs steady state, enzyme activities were significantly increased in VOE subjects after arginine-loading dose treatment. Arginine also decreased protein-carbonyl levels across all treatment doses (P < .01), suggesting a decrease in oxidative stress. Arginine therapy increases mitochondrial activity and reduces oxidative stress in children with SCD/VOE. This trial was registered at www.clinicaltrials.gov as #NCT02536170.",2020,"Arginine therapy also decreased protein-carbonyl levels across all treatment doses (p<0.01), suggesting a decrease in oxidative stress.","['Children with Sickle Cell Disease during Vaso-occlusive Pain', 'sickle cell disease (SCD', 'children with SCD/VOE', 'SCD patients with vaso-occlusive-painful-events (VOE', '12 children with SCD hospitalized for VOE (age 13.6±3 years, 67% male, 75% HbSS']","['arginine therapy', 'Arginine therapy', 'arginine', 'Arginine Therapy']","['mitochondrial activity', 'oxidative stress', 'complex-V activity', 'protein-carbonyl levels', 'Platelet-rich-plasma mitochondrial activity, protein expression, and protein-carbonyls', 'Mitochondrial Function', 'VOE platelets vs. steady state, enzyme activities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0069436', 'cui_str': 'oligomycin sensitivity-conferring protein'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}]",12.0,0.0192241,"Arginine therapy also decreased protein-carbonyl levels across all treatment doses (p<0.01), suggesting a decrease in oxidative stress.","[{'ForeName': 'Claudia R', 'Initials': 'CR', 'LastName': 'Morris', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Lou Ann S', 'Initials': 'LAS', 'LastName': 'Brown', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reynolds', 'Affiliation': 'Department of Pharmacology & Chemical Biology, Vascular Medicine Institute, Center for Metabolism & Mitochondrial Medicine (C3M), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Carlton D', 'Initials': 'CD', 'LastName': 'Dampier', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Lane', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Watt', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Polly', 'Initials': 'P', 'LastName': 'Kumari', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Harris', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Shaminy', 'Initials': 'S', 'LastName': 'Manoranjithan', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Reshika D', 'Initials': 'RD', 'LastName': 'Mendis', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA; and.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Figueroa', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Sruti', 'Initials': 'S', 'LastName': 'Shiva', 'Affiliation': 'Department of Pharmacology & Chemical Biology, Vascular Medicine Institute, Center for Metabolism & Mitochondrial Medicine (C3M), University of Pittsburgh, Pittsburgh, PA.'}]",Blood,['10.1182/blood.2019003672']
37,32387214,"Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis-an open labelled, randomized controlled trial.","AIMS & OBJECTIVES


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


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


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


SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalization, and can be considered as a safe and feasible alternative, in elective and emergency settings.",2020,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","['Patients who fulfilled the inclusion criteria', 'department of surgery in a tertiary care centre between October 2016 and March 2018', '106 patients were randomised, 52 in SLIA and 54 in DLIA']","['single layered intestinal anastomosis', 'single layer intestinal anastomosis (SLIA', 'Double layer intestinal anastomosis (DLIA', 'SLIA and patients undergoing DLIA']","['anastomotic leak, other complications, mortality and LOH.\nCONCLUSION', 'mortality, morbidity, and length of hospitalisation (LOH', 'Baseline demographic and clinicopathological characteristics', 'anastomotic leak, morbidity, mortality, and the length of hospitalisation', 'anastomotic leak, morbidity, mortality and LOH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",106.0,0.173847,"SLIA was comparable to DLIA with respect to incidence of anastomotic leak, morbidity, mortality, and the length of hospitalisation, and can be considered as a safe and feasible alternative, in elective and emergency settings.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aniruthan', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Amuda Ravichandar', 'Initials': 'AR', 'LastName': 'Pranavi', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Gubbi Shamanna', 'Initials': 'GS', 'LastName': 'Sreenath', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: dr.sreenathgs@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.066']
38,31018210,Pleural Cryobiopsy versus Flexible Forceps Biopsy in Subjects with Undiagnosed Exudative Pleural Effusions Undergoing Semirigid Thoracoscopy: A Crossover Randomized Trial (COFFEE Trial).,"BACKGROUND


There is no randomized study comparing pleural cryobiopsy (CB) and flexible forceps biopsy (FFB) in subjects undergoing medical thoracoscopy for the diagnosis of pleural effusions.
OBJECTIVE


In this crossover study, we compared the diagnostic yield of CB versus FFB in subjects undergoing semirigid thoracoscopy.
METHODS


Subjects undergoing semirigid thoracoscopy for undiagnosed pleural effusions were subjected to both CB and FFB, with the order of performing the biopsy randomized in a 1:1 ratio. The primary outcome was the diagnostic yield obtained with CB versus FFB. The secondary outcomes included the biopsy size, depth, histologic interpretability, artefacts, the difficulty of performing biopsy on an operator-rated visual analog scale, the severity of bleeding observed at the time of the biopsy, and the duration of the procedure.
RESULTS


Of the 201 subjects screened, 50 (mean age 52.4 years; 18 women) were included. The diagnostic yield of CB (78.0%) was not different from FFB (76.0%, p = 1.00). CB yielded a larger specimen than FFB (median size 7.0 vs. 4.0 mm; p < 0.001), and a greater depth of specimens (up to the pleural fat or deeper, CB vs. FFB 65.2 vs. 40.8%; p = 0.02). The CB procedure was quicker than FFB (median duration 10 vs. 15 min; p < 0.001). There were no significant differences in the difficulty of performing the biopsy, the severity of bleeding, histologic interpretability, or artefacts in the specimens between the CB and FFB groups.
CONCLUSION


The diagnostic yield of pleural CB was comparable to FFB during semirigid thoracoscopy.",2019,The CB procedure was quicker than FFB (median duration 10 vs. 15 min; p < 0.001).,"['Subjects undergoing semirigid thoracoscopy for undiagnosed pleural effusions', 'Subjects with Undiagnosed Exudative Pleural Effusions', 'subjects undergoing medical thoracoscopy for the diagnosis of pleural effusions', 'subjects undergoing semirigid thoracoscopy', '201 subjects screened, 50 (mean age 52.4 years; 18 women']","['pleural cryobiopsy (CB) and flexible forceps biopsy (FFB', 'Semirigid Thoracoscopy', 'CB versus FFB', 'Forceps Biopsy', 'Pleural Cryobiopsy versus Flexible']","['biopsy size, depth, histologic interpretability, artefacts, the difficulty of performing biopsy on an operator-rated visual analog scale, the severity of bleeding observed at the time of the biopsy, and the duration of the procedure', 'diagnostic yield obtained with CB versus FFB', 'diagnostic yield of CB', 'difficulty of performing the biopsy, the severity of bleeding, histologic interpretability, or artefacts']","[{'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0032227', 'cui_str': 'Pleural Effusion'}, {'cui': 'C3887491', 'cui_str': 'Exudative pleural effusion (disorder)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1522720', 'cui_str': 'Pleural (qualifier value)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0085089', 'cui_str': 'Artifacts'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]",,0.0601711,The CB procedure was quicker than FFB (median duration 10 vs. 15 min; p < 0.001).,"[{'ForeName': 'Sahajal', 'Initials': 'S', 'LastName': 'Dhooria', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Amanjit', 'Initials': 'A', 'LastName': 'Bal', 'Affiliation': 'Department of Histopathology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Inderpaul Singh', 'Initials': 'IS', 'LastName': 'Sehgal', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Kuruswamy Thurai', 'Initials': 'KT', 'LastName': 'Prasad', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Valliappan', 'Initials': 'V', 'LastName': 'Muthu', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Ashutosh Nath', 'Initials': 'AN', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Ritesh', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India, agarwal.ritesh@outlook.in.'}]",Respiration; international review of thoracic diseases,['10.1159/000497212']
39,32332464,Body Mass Index as a Moderator of Treatment Response to Ketamine for Major Depressive Disorder.,"PURPOSE/BACKGROUND


Major depressive disorder (MDD) and obesity commonly co-occur. We sought to assess the impact of body mass index (BMI) on the acute antidepressant effects of ketamine in patients with treatment-resistant depression.
METHODS/PROCEDURES


Post hoc analyses were conducted from a multisite, randomized, double-blind, placebo-controlled trial designed to assess the rapid-onset effects of intravenous ketamine. Patients (n = 99) were randomized to a single dose administration of ketamine 0.1 mg/kg (n = 18), ketamine 0.2 mg/kg (n = 20), ketamine 0.5 mg/kg (n = 22), ketamine 1.0 mg/kg (n = 20), or active placebo, midazolam 0.045 mg/kg (n = 19). Patients were stratified for BMI. For patients randomized to ketamine (n = 80), BMI was assessed as a continuous variable and also categorically (obese, overweight, not obese/overweight [reference]). The primary outcome measure was the change on the 6-item Hamilton Depression Rating Scale 24 hours after treatment. Outcomes at day 3 were also assessed.
FINDINGS/RESULTS


The 6-item Hamilton Depression Rating Scale change scores at 24 hours were inversely associated with BMI (-0.28 ± 0.12, P = 0.02). With BMI operationalized categorically, both obese (-4.15 ± 1.41, P = 0.004) and overweight (-1.99 ± 1.14, P = 0.08) categories were inversely related to the 6-item Hamilton Depression Rating Scale change score at 24 hours, statistically significant for the obese category, as compared with the reference group. Similar but weaker findings were observed at 72 hours after infusion.
IMPLICATIONS/CONCLUSIONS


Higher BMI and obesity were associated with a more robust acute antidepressant response to ketamine. This may have clinical relevance for a great number of patients who have both MDD and obesity.
CLINICAL TRIAL REGISTRATION


NCT01920555.",2020,"The 6-item Hamilton Depression Rating Scale change scores at 24 hours were inversely associated with BMI (-0.28 ± 0.12, P = 0.02).","['Patients (n = 99', 'patients who have both MDD and obesity', 'patients with treatment-resistant depression']","['Ketamine', 'placebo', 'ketamine 1.0 mg/kg (n = 20), or active placebo, midazolam', 'ketamine']","['Higher BMI and obesity', '6-item Hamilton Depression Rating Scale change scores', '6-item Hamilton Depression Rating Scale change score', '6-item Hamilton Depression Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",99.0,0.34729,"The 6-item Hamilton Depression Rating Scale change scores at 24 hours were inversely associated with BMI (-0.28 ± 0.12, P = 0.02).","[{'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'From the Department of Psychiatry, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Hock', 'Affiliation': 'From the Department of Psychiatry, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'From the Department of Psychiatry, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'From the Department of Psychiatry, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'From the Department of Psychiatry, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Department of Psychiatry, Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Department of Psychiatry, Yale University, New Haven, CT.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Department of Psychiatry, NYU School of Medicine and Nathan Kline Institute, New York, NY.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'DeBattista', 'Affiliation': 'Department of Psychiatry, Stanford University School of Medicine, Palo Alto, CA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern, Dallas, TX.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'From the Department of Psychiatry, Massachusetts General Hospital, Boston, MA.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001209']
40,31659242,A randomized controlled trial to determining the effect of cinnamon on the plasma levels of soluble forms of vascular adhesion molecules in type 2 diabetes mellitus.,"Soluble forms of vascular adhesion molecules, ICAM-1 and VCAM-1, accelerate atherosclerosis pathogenesis. The present study was conducted to evaluate the effect of daily supplementation of 3 g cinnamon on the plasma levels of ICAM-1 and VCAM-1 among patients with type 2 diabetes. This randomized double-blind placebo-controlled trial was performed on 44 adult patients with type 2 diabetes aged 25-70 years. The patients were randomized to two groups of intervention (n = 22) and control (n = 22), differing by daily cinnamon supplementation or placebo (3 g) for 8 weeks. Plasma levels of ICAM-1 and VCAM-1 were measured at the beginning and end of the study. After 8 weeks, 39 subjects (n = 20 in the cinnamon and n = 19 in the placebo groups) completed the trial. There was a significant reduction in the mean levels of ICAM-1 and VCAM-1 within cinnamon and placebo groups (P < 0.001). But there was no significant difference in ICAM-1 (P = 0.75) and VCAM-1 (P = 0.72) between the groups at the end of the trial. According to the results, cinnamon supplementation has no beneficial effect on the reduction of ICAM-1 and VCAM-1 levels in patients with type 2 diabetes, which have a role in the development of atherogenesis.",2019,There was a significant reduction in the mean levels of ICAM-1 and VCAM-1 within cinnamon and placebo groups (P < 0.001).,"['39 subjects (n\u2009=\u200920 in the cinnamon and n\u2009=\u200919 in the', 'patients with type 2 diabetes', 'type 2 diabetes mellitus', '44 adult patients with type 2 diabetes aged 25-70 years']","['placebo', 'cinnamon supplementation or placebo', 'cinnamon', 'cinnamon supplementation']","['plasma levels of ICAM-1 and VCAM-1', 'ICAM-1 and VCAM-1 levels', 'mean levels of ICAM-1 and VCAM-1', 'VCAM-1', 'ICAM-1', 'Plasma levels of ICAM-1 and VCAM-1']","[{'cui': 'C1112857', 'cui_str': 'Cinnamon'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1112857', 'cui_str': 'Cinnamon'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",39.0,0.30102,There was a significant reduction in the mean levels of ICAM-1 and VCAM-1 within cinnamon and placebo groups (P < 0.001).,"[{'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mirmiran', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Davari', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Hashemi', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hedayati', 'Affiliation': 'Cellular & Molecular Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shamim', 'Initials': 'S', 'LastName': 'Sahranavard', 'Affiliation': 'Department of Traditional Pharmacy, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Bahreini', 'Affiliation': 'Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Rahele', 'Initials': 'R', 'LastName': 'Tavakoly', 'Affiliation': 'Department of Nutrition, School of Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Talaei', 'Affiliation': 'Department of Nutrition, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran. b.talaei@kmu.ac.ir.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0523-9']
41,31957666,Vitamin D suppresses proangiogenic factors in patients with ulcerative colitis: A randomized double blind placebo controlled clinical trial.,"BACKGROUND


Angiogenesis and inflammation are involved in the pathogenesis of ulcerative colitis (UC). This study aimed to assess the effect of vitamin D on serum levels of proangiogenic factors, visfatin and vascular endothelial growth factor (VEGF), in patients with UC.
MATERIALS AND METHODS


Ninety patients were randomized to receive either a single intramuscular injection of 300,000 IU vitamin D or normal saline. Visfatin, VEGF, and 25-hydroxyvitamin D [25(OH)D] concentrations were assessed before and 90 days after the intervention.
RESULTS


There were no significant differences in visfatin and VEGF levels between the two groups following supplementation. In patients with vitamin D insufficiency, visfatin increase was significantly lower in the intervention versus placebo group. There was an inverse correlation between serum 25(OH)D and visfatin in the subgroup with vitamin D insufficiency.
CONCLUSION


Vitamin D might be beneficial in decreasing proangiogenic factors such as visfatin in UC patients with low 25(OH)D levels.",2020,"There was an inverse correlation between serum 25(OH)D and visfatin in the subgroup with vitamin D insufficiency.
","['Ninety patients', 'patients with UC', 'patients with ulcerative colitis', 'UC patients with low 25(OH)D levels']","['Vitamin D', 'vitamin D', 'vitamin D or normal saline', 'placebo']","['serum levels of proangiogenic factors, visfatin and vascular endothelial growth factor (VEGF', 'visfatin and VEGF levels', 'Visfatin, VEGF, and 25-hydroxyvitamin D [25(OH)D] concentrations', 'serum 25(OH)D and visfatin', 'visfatin increase']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0068707', 'cui_str': 'Visfatin'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",90.0,0.652088,"There was an inverse correlation between serum 25(OH)D and visfatin in the subgroup with vitamin D insufficiency.
","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Emami', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amrollah', 'Initials': 'A', 'LastName': 'Sharifi', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology (GRCGH), Golestan University of Medical Sciences (GOUMS), Gorgan, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Derakhshanian', 'Affiliation': 'Department of Biochemistry and Nutrition, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran; Dietary Supplements and Probiotic Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran; Centre of Research Excellence in Translating Nutritional Science to Good Health, Royal Adelaide Hospital, University of Adelaide, Adelaide, Australia. Electronic address: hosseinzadeh.md.phd@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101086']
42,31675390,Bypassing the blues: Insomnia in the depressed post-CABG population.,"BACKGROUND


BACKGROUND: Recovery from coronary artery bypass graft (CABG) surgery often is complicated by depression and insomnia, resulting in poorer health-related quality of life and clinical outcomes. We explored the relationships among depression, insomnia, quality of life, and the impact of a collaborative care strategy on reducing insomnia in patients after CABG surgery.
METHODS


METHODS: Patients with a Patient Health Questionnaire score ≥10 were randomized to nurse-delivered collaborative care for depression (n = 150) or their physician’s usual care (n = 152). A convenience sample of patients without depression (n = 151) served as the control group. Using the Hamilton Depression Rating Scale sleep questions, we created an “insomnia index.”
RESULTS


RESULTS: At baseline, 63% of participants who were depressed vs 12% of those who were not depressed reported insomnia. Compared with usual care, fewer collaborative care participants reported insomnia at 8 months, and they tended to have a lower insomnia score (insomnia index change score −0.95 and −1.47, respectively; P = .05) with no time-by- randomization interaction, Cohen’s d = 0.22 (95% confidence interval, −0.001 to 0.43). Participants with baseline insomnia reported greater improvements in mental health–related quality of life (Medical Outcomes Survey 36-item Short Form Mental Component Summary score; −3.32, P = .02), but insomnia was not a significant moderator of the effect of collaborative care.
CONCLUSIONS


CONCLUSIONS: This is the first study to examine the long-term impact on insomnia among post-CABG patients treated for depression. Future collaborative care studies could consider including a therapeutic focus for insomnia.",2020,"Short Form Mental Component Summary score; -3.32, P = .02), but insomnia was not a significant moderator of the effect of collaborative care.
","['patients without depression (n = 151) served as the control group', 'Patients with a Patient Health Questionnaire score ≥10', 'patients after CABG surgery', 'insomnia among post-CABG patients treated for depression', 'Participants with baseline insomnia']","[""nurse-delivered collaborative care for depression (n = 150) or their physician's usual care"", 'coronary artery bypass graft (CABG) surgery']","['insomnia', 'Hamilton Depression Rating Scale sleep questions', 'mental health-related quality of life ', 'insomnia score (insomnia index change score', 'insomnia index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.126656,"Short Form Mental Component Summary score; -3.32, P = .02), but insomnia was not a significant moderator of the effect of collaborative care.
","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Waterman', 'Affiliation': ''}, {'ForeName': 'Bea Herbeck', 'Initials': 'BH', 'LastName': 'Belnap', 'Affiliation': ''}, {'ForeName': 'Marie Anne', 'Initials': 'MA', 'LastName': 'Gebara', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': ''}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Rollman', 'Affiliation': ''}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Western Psychiatric Institute and Clinic, Pittsburgh, PA, 15213 USA. E-MAIL: karpjf@upmc.edu'}]",Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists,[]
43,32062566,Alleviation of ADHD symptoms by non-invasive right prefrontal stimulation is correlated with EEG activity.,"Attention deficit hyperactivity disorder (ADHD) is a prevalent disorder with effective pharmacological treatment that benefits most patients. However, about one-third fail to benefit while others search non-pharmacological alternatives, and for those options are scarce. One alternative treatment option is to alter abnormal right prefrontal cortex (rPFC) activity, given that rPFC abnormality has been repeatedly implicated in ADHD neurophathology. Here, we evaluated whether targeting the rPFC with multiple sessions of repetitive transcranial magnetic stimulation (rTMS), which can modulate neuronal excitability, activity, and plasticity in a non-invasive manner, will affect clinical symptoms in adults suffering from ADHD. Concomitantly, we used EEG to characterize electrophysiological alterations induced by treatment and to search for correlation between baseline neuronal activity and clinical response. Forty-three drug free adults with ADHD were randomized to receive either Real, Active Control, or Sham treatment (13 females, age ranging 21-46; n = 15, 14, 14, respectively), and underwent three weeks of daily high-frequency (18 Hz) stimulation sessions. We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085). Furthermore, based on EEG recorded within the first treatment session we established a novel biomarker, composed of the Alpha and Low-gamma power, which highly correlated the magnitude of the clinical outcome (r = 0.92, p = 0.0001). Taken together, the results of this pilot study indicate safety and effectiveness of rTMS directed to the rPFC for treatment of adult ADHD patients. The biomarker is suggested to reflect the responsiveness of the cortex to this rTMS intervention. Following validation of the results in larger samples, this study may represent a step towards a non-pharmacological treatment for adults with ADHD using EEG-based selection of optimal candidates for treatment.",2020,We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085).,"['Forty-three drug free adults with ADHD', 'adults suffering from ADHD', 'adult ADHD patients']","['Real, Active Control, or Sham treatment', 'repetitive transcranial magnetic stimulation (rTMS', 'rTMS']",['symptoms'],"[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0294365,We found that Real treatment was safe and resulted in significant improvement of symptoms (η 2 p  = 0.34; Cohen's d (against Sham)  = 0.96; Cohen's d (against AC)  = 0.68; p = 0.00085).,"[{'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Alyagon', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hamutal', 'Initials': 'H', 'LastName': 'Shahar', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Aviad', 'Initials': 'A', 'LastName': 'Hadar', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Barnea-Ygael', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Lazarovits', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hadar', 'Initials': 'H', 'LastName': 'Shalev', 'Affiliation': 'Psychiatry Department, Soroka Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'Department of Life Sciences and the Zlotowski Centre for Neuroscience,\xa0Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: azangen@bgu.ac.il.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102206']
44,31989459,"Prevention of Pain During Screening for Retinopathy of Prematurity: A Randomized Control Trial Comparing Breast Milk, 10% Dextrose and Sterile Water.","OBJECTIVES


To compare the efficacy of orally administered 10% dextrose, breast milk and sterile water on pain prevention during screening examination for Retinopathy of prematurity (ROP) in preterm neonates as measured by Premature infant pain profile (PIPP).
METHODS


A three-limbed double-blinded randomized control trial was conducted in a Level 3 neonatal intensive care unit. Forty five preterm neonates undergoing ROP screening were included. Eligible babies were randomly assigned to one of the three groups that orally received either expressed breast milk (n = 14), 10% dextrose solution (n = 14) or sterile water (n = 17), one minute before eye examination. The outcome measure was PIPP score.
RESULTS


All 3 groups were similar in baseline characteristics. The mean PIPP scores were comparable (p = 0.18) in the three groups (11.8 ± 2.8 vs. 9.8 ± 3.3 vs. 10.2 ± 2.9). The behavioral and physiological variables were also similar across all three groups.
CONCLUSIONS


Expressed breast milk, 10% dextrose or sterile water administered orally before ROP screening in preterm neonates have similar analgesic effects and do not significantly alleviate pain during the procedure.",2020,The mean PIPP scores were comparable (p = 0.18) in the three groups (11.8 ± 2.8 vs. 9.8 ± 3.3 vs. 10.2 ± 2.9).,"['Forty five preterm neonates undergoing ROP screening were included', 'Retinopathy of Prematurity', 'Eligible babies', 'Level 3 neonatal intensive care unit']","['expressed breast milk (n\u2009=\u200914), 10% dextrose solution (n\u2009=\u200914) or sterile water', '10% dextrose, breast milk and sterile water on pain prevention', 'Dextrose and Sterile Water']","['mean PIPP scores', 'analgesic effects', 'PIPP score', 'alleviate pain', 'Retinopathy of prematurity (ROP']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0456949', 'cui_str': 'Level 3 (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0452739', 'cui_str': 'Expressed breast milk (substance)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}]",45.0,0.608043,The mean PIPP scores were comparable (p = 0.18) in the three groups (11.8 ± 2.8 vs. 9.8 ± 3.3 vs. 10.2 ± 2.9).,"[{'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Nayak', 'Affiliation': 'Department of Pediatrics, Melaka Manipal Medical College, Manipal Academy of Higher Education, Manipal, India. dr.ramyanayak@gmail.com.'}, {'ForeName': 'Kalale Nikhil', 'Initials': 'KN', 'LastName': 'Nagaraj', 'Affiliation': 'Department of Pediatrics, Motherhood Hospital, Sahakarnagar, Bangalore, India.'}, {'ForeName': 'Girish', 'Initials': 'G', 'LastName': 'Gururaj', 'Affiliation': 'Department of Neonatology, Apollo BGS Hospitals, Mysore, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03182-6']
45,32333208,Modified Antiretroviral Treatment Access Study (MARTAS): A Randomized Controlled Trial of the Efficacy of a Linkage-to-Care Intervention Among HIV-Positive Patients in Ukraine.,"Between October 2015 and March 2018, we conducted the Modified Antiretroviral Treatment Access Study (MARTAS), a nurse-delivered case management intervention to improve linkage-to-care for persons recently tested HIV positive. Adult participants from nine urban clinics in three regions of Ukraine were randomized to either MARTAS or standard of care (SOC) using individual, parallel, two-arm design. The main study outcome was linkage-to-care (defined as registration at an HIV clinic) within a 3-month period from enrollment in the study. Intention-to-treat analysis of MARTAS (n = 135) versus SOC (n = 139) showed intervention efficacy in linkage to HIV care (84.4% vs. 33.8%; adjusted RR 2.45; 95% CI 1.72, 3.47; p < 0.001). MARTAS is recommended for implementation in Ukraine and may be helpful in other countries with similar gaps in linkage-to-care. Clinicaltrials.gov registration number: NCT02338024.",2020,MARTAS is recommended for implementation in Ukraine and may be helpful in other countries with similar gaps in linkage-to-care.,"['Adult participants from nine urban clinics in three regions of Ukraine', 'HIV-Positive Patients in Ukraine']","['nurse-delivered case management intervention to improve linkage-to-care for persons recently tested HIV positive', 'MARTAS or standard of care (SOC', 'Linkage-to-Care Intervention']","['intervention efficacy', 'linkage-to-care (defined as registration at an HIV clinic']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",,0.271332,MARTAS is recommended for implementation in Ukraine and may be helpful in other countries with similar gaps in linkage-to-care.,"[{'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Neduzhko', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine. neduzhko@uiphp.org.ua.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Postnov', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine.'}, {'ForeName': 'Yuliia', 'Initials': 'Y', 'LastName': 'Sereda', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine.'}, {'ForeName': 'Roksolana', 'Initials': 'R', 'LastName': 'Kulchynska', 'Affiliation': 'Division of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Kiev, Ukraine.'}, {'ForeName': 'Trista', 'Initials': 'T', 'LastName': 'Bingham', 'Affiliation': 'Division of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Janet J', 'Initials': 'JJ', 'LastName': 'Myers', 'Affiliation': 'Prevention Research Center, University of California, San Francisco, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Flanigan', 'Affiliation': 'Alpert Medical School, Brown University, Providence, USA.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Kiriazova', 'Affiliation': 'Ukrainian Institute on Public Health Policy, 5 Mala Zhytomyrska str., Office 61A, Kiev, 01001, Ukraine.'}]",AIDS and behavior,['10.1007/s10461-020-02873-7']
46,32383736,An Avatar-Led Intervention Promotes Smoking Cessation in Young Adults: A Pilot Randomized Clinical Trial.,"BACKGROUND


Smoking remains a global concern, especially for young adults. There is a dearth of smoking cessation programs for this population, who seldom seek help or are motivated to quit.
PURPOSE


This pilot study assessed the effectiveness of a digital avatar-led Acceptance and Commitment Therapy (ACT) smoking cessation program (Flexiquit) for young adult smokers at all levels of motivation to quit.
METHODS


Smokers with no particular interest in quitting smoking (65.45% reported being in pre-contemplation or contemplation stages of change) were recruited from three universities (105 smoking ≥ 1 cigarette per day during the past 30 days, 68 females). Those who completed questionnaires online (N = 84; M = 22.44 years, SD = 2.61, range 18-28 years old) were randomized to either a six-session avatar-led intervention (Flexiquit; N = 49) or a wait-list control (N = 35). Primary outcomes included cessation status (7-day point prevalence) and number of cigarettes smoked per day; secondary outcomes were nicotine dependence, intention-to-quit smoking and self-efficacy, assessed at pre- and post-intervention, and only for Flexiquit at 6-month follow-up.
RESULTS


In intention-to-treat analysis more participants (OR = 3.10, 95% CI = 0.92-10.41) in the treatment group (28.57%) versus the control group (11.43%) reported quitting smoking; however, the difference was not statistically significant (p = .067). There were statistically significant decreases in average number of cigarettes, nicotine dependence and increases in self-efficacy, and intention-to-quit smoking compared to controls. Treatment gains in the Flexiquit group were maintained through the 6-month follow-up.
CONCLUSIONS


An avatar-led digitized smoking cessation intervention based on ACT could increase the odds of quitting smoking. Findings suggest that a digitized program designed to engage young adults in smoking cessation may result in quitting smoking and has a high applicability potential especially among the hard-to-reach population of young adults.
QUESTION


Can an avatar-led digitized Acceptance and Commitment Therapy (ACT) smoking cessation intervention result in quitting smoking and increasing intention to quit among young smokers at various levels of motivation to quit, compared to a wait-list control group?
FINDINGS


In this pilot randomized clinical trial that included 84 smokers, 28.57% in the treatment condition versus 11.43% in the wait-list control group were abstinent at post (intention-to-treat [ITT] analysis). An avatar-led digitized ACT smoking cessation intervention results in high quitting smoking rates and has a high applicability potential especially among the hard-to-reach population of young adult smokers.",2020,"In intention-to-treat analysis more participants (OR = 3.10, 95% CI = 0.92-10.41) in the treatment group (28.57%) versus the control group (11.43%) reported quitting smoking; however, the difference was not statistically significant (p = .067).","['young adults', 'M = 22.44 years, SD = 2.61, range 18-28 years old', 'Findings', 'Smokers with no particular interest in quitting smoking (65.45% reported being in pre-contemplation or contemplation stages of change) were recruited from three universities (105 smoking ≥ 1 cigarette per day during the past 30 days, 68 females', 'Young Adults', 'included 84 smokers, 28.57% in the treatment condition versus 11.43% in the wait-list control group were abstinent at post (intention-to-treat [ITT] analysis', 'young adult smokers at all levels of motivation to quit']","['Avatar-Led Intervention Promotes Smoking Cessation', 'six-session avatar-led intervention (Flexiquit; N = 49) or a wait-list control', 'avatar-led digitized ACT smoking cessation intervention', 'digital avatar-led Acceptance and Commitment Therapy (ACT) smoking cessation program (Flexiquit', 'avatar-led digitized Acceptance and Commitment Therapy (ACT) smoking cessation intervention']","['average number of cigarettes, nicotine dependence and increases in self-efficacy, and intention-to-quit smoking', 'odds of quitting smoking', 'cessation status (7-day point prevalence) and number of cigarettes smoked per day; secondary outcomes were nicotine dependence, intention-to-quit smoking and self-efficacy, assessed at pre- and post-intervention, and only for Flexiquit at 6-month follow-up', 'quitting smoking']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1277196', 'cui_str': 'Contemplation stage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.0636314,"In intention-to-treat analysis more participants (OR = 3.10, 95% CI = 0.92-10.41) in the treatment group (28.57%) versus the control group (11.43%) reported quitting smoking; however, the difference was not statistically significant (p = .067).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karekla', 'Affiliation': 'Department of Psychology, University of Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Stella Nicoleta', 'Initials': 'SN', 'LastName': 'Savvides', 'Affiliation': 'Department of Psychology, University of Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gloster', 'Affiliation': 'Faculty of Clinical Psychology and Intervention Science, University of Basel, Basel, Switzerland.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa013']
47,32385676,Using an HIV Self-test Kit to Test a Partner: Attitudes and Preferences Among High-Risk Populations.,"For those most at risk of contracting HIV, new strategies for preventing transmission and increasing testing are needed. As part of a multi-site, randomized, controlled trial, we explored attitudes and preferences among 272 HIV-negative men who have sex with men and HIV-negative transgender women using an HIV self-testing (HIVST) kit to test partners. Less than one quarter had previously self-tested with HIVST kits (21.7%) and few had partner-tested (4.8%). Most preferred gum swab (96%) over fingerprick tests (69%), but would prefer a blood test if it gave results for other sexually transmitted infections (STIs) (86%). Five percent reported difficulties performing the test, four percent with storage, and 26% with portability. Ninety-three percent reported likelihood of using HIVST to test partners in future, but only 3% were willing to pay the current price. Efforts to improve HIVST uptake should focus on incorporating testing for other STIs, reducing test kit size, and reducing cost.",2020,"Most preferred gum swab (96%) over fingerprick tests (69%), but would prefer a blood test if it gave results for other sexually transmitted infections (STIs) (86%).",['272 HIV-negative men who have sex with men and HIV-negative transgender women using an HIV self-testing (HIVST) kit to test partners'],[],[],"[{'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]",[],[],272.0,0.0162985,"Most preferred gum swab (96%) over fingerprick tests (69%), but would prefer a blood test if it gave results for other sexually transmitted infections (STIs) (86%).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Iribarren', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, USA. sjiribar@uw.edu.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Alan Z', 'Initials': 'AZ', 'LastName': 'Sheinfil', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tagliaferri Rael', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'Division of Gender, Sexuality and Health, HIV Center for Clinical and Behavioral Studies, NY State Psychiatric Institute and Columbia University, New York, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02885-3']
48,32396917,"Improving Cost-effectiveness and Access to Cognitive Behavior Therapy for Depression: Providing Remote-Ready, Computer-Assisted Psychotherapy in Times of Crisis and Beyond.","INTRODUCTION


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


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


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


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


A method of CCBT that blended internet-delivered modules and abbreviated therapeutic contact reduced the cost of treatment substantially without adversely affecting outcomes. Results suggest that use of this approach can more than double the access to CBT. Because clinician support in CCBT can be provided by telephone, videoconference, and/or email, this highly efficient form of treatment could be a major advance in remote treatment delivery.",2020,A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact).,"['154 drug-free major depressive disorder outpatients', 'Depression']","['cognitive behavior therapy (CCBT', 'Cognitive Behavior Therapy', 'therapist-supported method for CCBT', 'CCBT', 'standard cognitive behavior therapy (CBT', 'standard CBT']",['cost-effectiveness'],"[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0290312,A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact).,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA, thase@pennmedicine.upenn.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's College, London, United Kingdom.""}, {'ForeName': 'Marna S', 'Initials': 'MS', 'LastName': 'Barrett', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Tracy D', 'Initials': 'TD', 'LastName': 'Eells', 'Affiliation': 'Unversity of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Balasubramani', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Brown', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jesse H', 'Initials': 'JH', 'LastName': 'Wright', 'Affiliation': 'Unversity of Louisville, Louisville, Kentucky, USA.'}]",Psychotherapy and psychosomatics,['10.1159/000508143']
49,32335900,"The impact of respiratory protective equipment on difficult airway management: a randomised, crossover, simulation study.","The current international COVID-19 health crisis underlines the importance of adequate and suitable personal protective equipment for clinical staff during acute airway management. This study compares the impacts of standard air-purifying respirators and powered air-purifying respirators during simulated difficult airway scenarios. Twenty-five anaesthetists carried out four different standardised difficult intubation drills, either unprotected (control), or wearing a standard or a powered respirator. Treatment times and wearer comfort were determined and compared. In the wearer comfort evaluation form, operators rated mobility, noise, heat, vision and speech intelligibility. All anaesthetists accomplished the treatment objectives of all study arms without adverse events. Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™; 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope; 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope; and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard tracheal intubation by direct laryngoscopy, respectively. Videolaryngoscopy allowed the shortest intubation times regardless of the respiratory protective device used. Anaesthetists rated heat and vision significantly higher in the powered respirator group; however, noise levels were perceived to be significantly lower than in the standard respirator group. We conclude that standard and powered respirators do not significantly prolong simulated advanced intubation procedures.",2020,"Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™, 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope, 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope, and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard endotracheal intubation by direct laryngoscopy, respectively.",[],"['standard air purifying respirators and powered air purifying respirators', 'respiratory protective equipment', 'standardised difficult intubation drills, either unprotected (control), or wearing a standard, or a powered respirator', 'Videolaryngoscopy']","['Total mean (SD) intubation times', 'Anaesthetists rated heat and vision', 'operators rated mobility, noise, heat, vision, and speech intelligibility', 'Treatment times and wearer comfort', 'noise levels']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0549401', 'cui_str': 'Difficult intubation'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",25.0,0.0444717,"Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™, 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope, 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope, and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard endotracheal intubation by direct laryngoscopy, respectively.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schumacher', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Arlidge', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dudley', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sicinski', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}]",Anaesthesia,['10.1111/anae.15102']
50,31373782,Ventricular remodeling in ischemic heart failure stratifies responders to stem cell therapy.,"Response to stem cell therapy in heart failure is heterogeneous, warranting a better understanding of outcome predictors. This study assessed left ventricular volume, a surrogate of disease severity, on cell therapy benefit. Small to large infarctions were induced in murine hearts to model moderate, advanced, and end-stage ischemic cardiomyopathy. At 1 month postinfarction, cardiomyopathic cohorts with comparable left ventricular enlargement and dysfunction were randomized 1:1 to those that either received sham treatment or epicardial delivery of cardiopoietic stem cells (CP). Progressive dilation and pump failure consistently developed in sham. In comparison, CP treatment produced significant benefit at 1 month post-therapy, albeit with an efficacy impacted by cardiomyopathic stage. Advanced ischemic cardiomyopathy was the most responsive to CP-mediated salvage, exhibiting both structural and functional restitution, with proteome deconvolution substantiating that cell therapy reversed infarction-induced remodeling of functional pathways. Moderate cardiomyopathy was less responsive to CP therapy, improving contractility but without reversing preexistent heart enlargement. In end-stage disease, CP therapy showed the least benefit. This proof-of-concept study thus demonstrates an optimal window, or ""Goldilocks principle,"" of left ventricular enlargement for maximized stem cell-based cardiac repair. Disease severity grading, prior to cell therapy, should be considered to inform regenerative medicine interventions.",2020,"In end-stage disease, CP therapy showed least benefit.",[],"['CP', 'sham treatment or epicardial delivery of cardiopoietic (CP) stem cells']",['Progressive dilation and pump failure'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.0179931,"In end-stage disease, CP therapy showed least benefit.","[{'ForeName': 'Satsuki', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Cardiovascular Medicine, Center for Regenerative Medicine, Marriott Heart Disease Research Program, Van Cleve Cardiac Regenerative Medicine Program, Rochester, Minnesota.'}, {'ForeName': 'D Kent', 'Initials': 'DK', 'LastName': 'Arrell', 'Affiliation': 'Department of Cardiovascular Medicine, Center for Regenerative Medicine, Marriott Heart Disease Research Program, Van Cleve Cardiac Regenerative Medicine Program, Rochester, Minnesota.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Rosenow', 'Affiliation': 'Department of Cardiovascular Medicine, Center for Regenerative Medicine, Marriott Heart Disease Research Program, Van Cleve Cardiac Regenerative Medicine Program, Rochester, Minnesota.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Bartunek', 'Affiliation': 'Cardiovascular Center, OLV Hospital, Aalst, Belgium.'}, {'ForeName': 'Atta', 'Initials': 'A', 'LastName': 'Behfar', 'Affiliation': 'Department of Cardiovascular Medicine, Center for Regenerative Medicine, Marriott Heart Disease Research Program, Van Cleve Cardiac Regenerative Medicine Program, Rochester, Minnesota.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Terzic', 'Affiliation': 'Department of Cardiovascular Medicine, Center for Regenerative Medicine, Marriott Heart Disease Research Program, Van Cleve Cardiac Regenerative Medicine Program, Rochester, Minnesota.'}]",Stem cells translational medicine,['10.1002/sctm.19-0149']
51,30509553,"The iCook 4-H Study: Report on Physical Activity and Sedentary Time in Youth Participating in a Multicomponent Program Promoting Family Cooking, Eating, and Playing Together.","OBJECTIVE


To report physical activity and sedentary time outcomes of youth in iCook 4-H.
STUDY DESIGN AND SETTING


iCook 4-H was a 5-state, randomized, control-treatment, family-based childhood obesity prevention intervention promoting cooking, eating, and playing together.
PARTICIPANTS AND INTERVENTION


Youth aged 9-10 years and the main preparer of their meals participated in the 12-week program followed by monthly newsletters and biyearly booster sessions until 24 months.
MAIN OUTCOME MEASURE(S)


A total of 155 youth were fitted with an Actigraph GT3X+ accelerometer, which they wore for 7 days at baseline and 4, 12, and 24 months to measure mean daily minutes per hour of waking wear time for sedentary time (ST), light physical activity (PA) (LPA), moderate PA, vigorous PA, and moderate to vigorous PA. Self-reported PA was assessed using the Block Kids Physical Activity Screener and additional questions querying for the program goal of the frequency of family actively playing together. Linear mixed models were used to determine differences from baseline to 24 months. Significance was set at P ≤ .05.
RESULTS


There was a significant (P < .05) group × time interaction for LPA (adjusted interaction B estimate, 95% confidence interval; 0.18 [0.05, 0.30]) and ST (-0.15 [-0.26, -0.04]); ST increased and LPA decreased in the treatment group. There were no differences in other accelerometer-derived PA measures, self-report Block Kids Physical Activity Screener measures, or frequency of family actively playing together at any time point.
CONCLUSIONS AND IMPLICATIONS


iCook 4-H was a multicomponent program observing youth aged 9-10 years for 24 months that focused on enhancing cooking skills, mealtime behavior and conversation, and PA through daily family activities. Greater emphasis on developing PA skills, changing environmental factors, and increasing PA both in and after school may be needed.",2019,"There were no differences in other accelerometer-derived PA measures, self-report Block Kids Physical Activity Screener measures, or frequency of family actively playing together at any time point.
","['Youth aged 9-10 years and the main preparer of their meals participated in the 12-week', 'A total of 155 youth', 'Youth Participating in a Multicomponent Program Promoting Family Cooking, Eating, and Playing Together', 'youth in iCook 4-H']","['program followed by monthly newsletters and biyearly booster sessions until 24 months', 'control-treatment, family-based childhood obesity prevention intervention promoting cooking, eating, and playing together', 'iCook 4-H', 'Actigraph GT3X+ accelerometer']","['LPA', 'waking wear time for sedentary time (ST), light physical activity (PA) (LPA), moderate PA, vigorous PA, and moderate to vigorous PA', 'accelerometer-derived PA measures, self-report Block Kids Physical Activity Screener measures, or frequency of family actively playing together at any time point']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0032214', 'cui_str': 'Play'}]",155.0,0.0192546,"There were no differences in other accelerometer-derived PA measures, self-report Block Kids Physical Activity Screener measures, or frequency of family actively playing together at any time point.
","[{'ForeName': 'Kendra K', 'Initials': 'KK', 'LastName': 'Kattelmann', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Brookings, SD. Electronic address: kendra.kattelmann@sdstate.edu.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Meendering', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Brookings, SD.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Hofer', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Brookings, SD.'}, {'ForeName': 'Chase M', 'Initials': 'CM', 'LastName': 'Merfeld', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Brookings, SD.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Olfert', 'Affiliation': 'Division of Animal and Nutritional Sciences in Human Nutrition and Foods, West Virginia University, Morgantown, WV.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Hagedorn', 'Affiliation': 'Division of Animal and Nutritional Sciences in Human Nutrition and Foods, West Virginia University, Morgantown, WV.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Colby', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Franzen-Castle', 'Affiliation': 'Nutrition and Health Sciences Department, University of Nebraska-Lincoln, Lincoln, NE.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Moyer', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Mathews', 'Affiliation': 'School of Food and Agriculture, University of Maine, Orono, ME.'}, {'ForeName': 'Adrienne A', 'Initials': 'AA', 'LastName': 'White', 'Affiliation': 'School of Food and Agriculture, University of Maine, Orono, ME.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.09.002']
52,31939839,Anesthetic Management Using Multiple Closed-loop Systems and Delayed Neurocognitive Recovery: A Randomized Controlled Trial.,"BACKGROUND


Cognitive changes after anesthesia and surgery represent a significant public health concern. We tested the hypothesis that, in patients 60 yr or older scheduled for noncardiac surgery, automated management of anesthetic depth, cardiac blood flow, and protective lung ventilation using three independent controllers would outperform manual control of these variables. Additionally, as a result of the improved management, patients in the automated group would experience less postoperative neurocognitive impairment compared to patients having standard, manually adjusted anesthesia.
METHODS


In this single-center, patient-and-evaluator-blinded, two-arm, parallel, randomized controlled, superiority study, 90 patients having noncardiac surgery under general anesthesia were randomly assigned to one of two groups. In the control group, anesthesia management was performed manually while in the closed-loop group, the titration of anesthesia, analgesia, fluids, and ventilation was performed by three independent controllers. The primary outcome was a change in a cognition score (the 30-item Montreal Cognitive Assessment) from preoperative values to those measures 1 week postsurgery. Secondary outcomes included a battery of neurocognitive tests completed at both 1 week and 3 months postsurgery as well as 30-day postsurgical outcomes.
RESULTS


Forty-three controls and 44 closed-loop patients were assessed for the primary outcome. There was a difference in the cognition score compared to baseline in the control group versus the closed-loop group 1 week postsurgery (-1 [-2 to 0] vs. 0 [-1 to 1]; difference 1 [95% CI, 0 to 3], P = 0.033). Patients in the closed-loop group spent less time during surgery with a Bispectral Index less than 40, had less end-tidal hypocapnia, and had a lower fluid balance compared to the control group.
CONCLUSIONS


Automated anesthetic management using the combination of three controllers outperforms manual control and may have an impact on delayed neurocognitive recovery. However, given the study design, it is not possible to determine the relative contribution of each controller on the cognition score.",2020,There was a difference in the cognition score compared to baseline in the control group versus the closed-loop group 1 week postsurgery (-1 [-2 to 0] vs. 0,"['90 patients having noncardiac surgery under general anesthesia', 'patients 60 yr or older scheduled for noncardiac surgery, automated management of anesthetic depth, cardiac blood flow, and protective lung ventilation using three independent controllers would outperform manual control of these variables']",['Anesthetic Management Using Multiple Closed-loop Systems'],"['battery of neurocognitive tests', 'change in a cognition score (the 30-item Montreal Cognitive Assessment', 'postoperative neurocognitive impairment', 'cognition score', '30-day postsurgical outcomes', 'fluid balance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0554804', 'cui_str': 'Ventilation assistance'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3496286'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}]",90.0,0.136412,There was a difference in the cognition score compared to baseline in the control group versus the closed-loop group 1 week postsurgery (-1 [-2 to 0] vs. 0,"[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Joosten', 'Affiliation': 'From the Department of Anesthesiology (A.J., A.B., V.J., L.V.O, L.B.) Department of Clinical and Cognitive Neuropsychology (H.S.) Erasme Hospital, and Department of Anesthesiology, Brugmann Hospital (P.V.d.L.), Université Libre de Bruxelles, Brussels, Belgium Department of Anesthesiology and Intensive Care, University of Paris-Saclay, Bicetre Hospital, Le Kremlin-Bicêtre, Paris, France (A.J.) Department of Anesthesiology and Perioperative Care, University of California, Irvine, Irvine, California (J.R.) Department of Anesthesiology, University of California, San Diego, San Diego, California (B.A.) Department of Anesthesiology and Perioperative Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California (M.C., S.V.) Department of Anesthesiology, Foch Hospital, Suresnes, Paris, France (N.L.) Outcome Research Consortium, Cleveland Clinic, Cleveland, Ohio (N.L.).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rinehart', 'Affiliation': ''}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Bardaji', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van der Linden', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Jame', 'Affiliation': ''}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Obbergh', 'Affiliation': ''}, {'ForeName': 'Brenton', 'Initials': 'B', 'LastName': 'Alexander', 'Affiliation': ''}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Cannesson', 'Affiliation': ''}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Vacas', 'Affiliation': ''}, {'ForeName': 'Ngai', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Hichem', 'Initials': 'H', 'LastName': 'Slama', 'Affiliation': ''}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Barvais', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003014']
53,30926955,"Effects of liraglutide on appetite, food preoccupation, and food liking: results of a randomized controlled trial.","BACKGROUND


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


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


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


Consistent with short-term studies, IBT-liraglutide participants reported greater improvements in hunger, fullness, and food preoccupation than those assigned to IBT-alone. Differences in appetite persisted for 24 weeks but were not maintained at week 52, despite the relatively greater weight losses in the liraglutide-treated participants at the trial's end.",2020,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","['113 adults with obesity (76.1% female, 55.8% white, BMI\u2009=\u200938.8\u2009±\u20094.8\u2009kg/m 2 ) who participated in a 52-week trial']","['intensive behavioral therapy alone (IBT-alone), IBT with liraglutide 3.0\u2009mg/day (IBT-liraglutide), or IBT-liraglutide combined with a 12-week meal replacement diet (Multi-component', 'IBT-alone, IBT-liraglutide', 'IBT-alone and Multi-component', 'IBT-liraglutide', 'liraglutide']","['hunger, fullness, and food preoccupation', 'liking of meals relative', 'hunger, fullness after meals, liking of meals, and food preoccupation', 'fullness', 'weight losses', 'food preoccupation', 'appetite', 'visual analogue scales', 'appetite, food preoccupation, and food liking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation with ideas'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",113.0,0.0597185,"Multi-component participants reported reduced liking of meals relative to the IBT-alone and IBT-liraglutide groups through weeks 40 and 52, respectively.","[{'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Zayna M', 'Initials': 'ZM', 'LastName': 'Bakizada', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Psychiatry, Center for Weight and Eating Disorders, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0348-6']
54,31917608,Delaminated Rotator Cuff Tears Showed Lower Short-term Retear Rates After Arthroscopic Double-Layer Repair Versus Bursal Layer-Only Repair: A Randomized Controlled Trial.,"BACKGROUND


The rotator cuff is known to consist of 2 macroscopically visible layers that have different biomechanical properties. Sometimes the inferior layer may be neglected during rotator cuff repair. However, it is controversial whether double-layer (DL) repair is superior to single-layer (SL) repair in terms of retear rate and outcome.
PURPOSE


To investigate whether DL as compared with SL repair could decrease retear rates after arthroscopic reconstruction of posterosuperior rotator cuff tears.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


A total of 70 patients were 1:1 randomized to receive an arthroscopic DL reconstruction (study group: DL suture-bridge repair) or SL reconstruction (control group: SL suture-bridge repair) for posterosuperior tears of the rotator cuff between 2.0 and 3.5 cm of the footprint detachment. Exclusion criteria were subscapularis tendon rupture (Lafosse >1°), fatty muscular infiltration >2°, and nondelaminated tendons. Tendon integrity according to Sugaya, fatty degeneration, and muscular atrophy were evaluated by magnetic resonance tomography. Pre- and postoperative evaluations included the Constant score, range of motion, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, subjective shoulder value, and postoperative satisfaction with the procedure. Complications were monitored throughout the study.
RESULTS


Ninety percent of patients (n = 34, DL; n = 29, SL) were followed-up. There were no significant group differences regarding baseline characteristics and pre- and postoperative fatty degeneration of the supraspinatus and atrophy of the supraspinatus and infraspinatus. The rate of magnetic resonance-verified intact repairs (Sugaya grades 1 + 2) was significantly higher in the DL group (70.6%) than in the SL group (44.8%;  P  = .045). One patient in the control group with a retear underwent revision. All functional and subjective scores improved significantly pre- to postoperatively in both groups ( P  < .05). No significant group differences were detected regarding postoperative Constant score, forward flexion, external rotation, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, subjective shoulder value, and visual analog scale and between intact and retorn tendons. The majority of patients were very satisfied or satisfied with their arthroscopic procedure (DL, 94.1%; SL, 92.9%).
CONCLUSION


This randomized controlled trial showed significantly lower retear rates after DL repair as compared with SL repair in delaminated rotator cuff tears. Clinical short-term outcome was not different between the DL and SL repair groups.
REGISTRATION


NCT003362320 (ClinicalTrials.gov identifier).",2020,"No significant group differences were detected regarding postoperative Constant score, forward flexion, external rotation, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, subjective shoulder value, and visual analog scale and between intact and retorn tendons.","['delaminated rotator cuff tears', 'A total of 70 patients']","['posterosuperior tears of the rotator cuff between 2.0 and 3.5 cm of the footprint detachment', 'DL', 'Arthroscopic Double-Layer Repair Versus Bursal Layer-Only Repair', 'SL repair', 'arthroscopic DL reconstruction (study group: DL suture-bridge repair) or SL reconstruction (control group: SL suture-bridge repair']","['Tendon integrity according to Sugaya, fatty degeneration, and muscular atrophy', 'postoperative Constant score, forward flexion, external rotation, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, subjective shoulder value, and visual analog scale and between intact and retorn tendons', 'Constant score, range of motion, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, subjective shoulder value, and postoperative satisfaction with the procedure', 'retear rates', 'rate of magnetic resonance-verified intact repairs', 'All functional and subjective scores', 'baseline characteristics and pre- and postoperative fatty degeneration of the supraspinatus and atrophy of the supraspinatus and infraspinatus', 'Complications', 'Delaminated Rotator Cuff Tears Showed Lower Short-term Retear Rates']","[{'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0541879', 'cui_str': 'Detachment'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C0026846', 'cui_str': 'Atrophy, Muscle'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0584882', 'cui_str': 'Infraspinatus'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",70.0,0.312707,"No significant group differences were detected regarding postoperative Constant score, forward flexion, external rotation, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, subjective shoulder value, and visual analog scale and between intact and retorn tendons.","[{'ForeName': 'Philipp R', 'Initials': 'PR', 'LastName': 'Heuberer', 'Affiliation': 'Vienna Shoulder and Sports Clinic, Vienna, Austria.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Pauzenberger', 'Affiliation': 'Vienna Shoulder and Sports Clinic, Vienna, Austria.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Gruber', 'Affiliation': 'The Medical University Vienna, Austria.'}, {'ForeName': 'Roman C', 'Initials': 'RC', 'LastName': 'Ostermann', 'Affiliation': 'Vienna Shoulder and Sports Clinic, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hexel', 'Affiliation': 'Vienna Shoulder and Sports Clinic, Vienna, Austria.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Laky', 'Affiliation': 'Vienna Shoulder and Sports Clinic, Vienna, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Anderl', 'Affiliation': 'Vienna Shoulder and Sports Clinic, Vienna, Austria.'}]",The American journal of sports medicine,['10.1177/0363546519897033']
55,32374188,Effects of a highly controlled carbohydrate-reduced high-protein diet on markers of oxidatively generated nucleic acid modifications and inflammation in weight stable participants with type 2 diabetes; a randomized controlled trial.,"Carbohydrate-restricted diets are increasingly recognized as options for dietary management of type 2 diabetes mellitus (T2DM). We investigated the effects of a carbohydrate-reduced high-protein (CRHP) and a conventional diabetes (CD) diet on oxidative stress and inflammation in weight stable individuals with T2DM. We hypothesized that the CRHP diet would improve markers of oxidatively generated RNA and DNA modifications as well as inflammatory parameters. Thirty participants with T2DM were randomized to 6 weeks of CRHP or CD dietary treatment (30/50 energy percentage (E%) carbohydrate, 30/17E% protein, 40/33E% fat), followed by a cross-over to the opposite diet for a subsequent 6-week period. All meals were provided during the study and body weight was controlled. Diurnal urine samples were collected after 4 weeks on each diet and oxidatively generated RNA and DNA modifications were measured as 8-oxo-7,8-dihydroguanosine (8-oxoGuo) and 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG), respectively. Fasting concentrations of soluble urokinase plasminogen activator receptor, high-sensitivity C-reactive protein, tumor necrosis factor alpha and interleukin-6 were measured before and after 6 weeks of interventions. Compared with the CD diet, the CRHP diet increased 24-hour urinary excretion of 8-oxoGuo by 9.3% (38.6 ± 12.6 vs. 35.3 ± 11.0 nmol/24 h,  p =  .03), whereas 8-oxodG did not differ between diets (24.0 ± 9.5 vs. 24.8 ± 11.1 nmol/24 h,  p  = .17). Changes in plasma inflammatory parameters did not differ between CRHP and CD diets, all  p ≥  .2. The clinical implications of increased RNA oxidation following a CRHP diet as well as long-term effects of carbohydrate-restriction on markers of oxidatively generated nucleic acid modifications should be a field of future study.",2020,"Changes in plasma inflammatory parameters did not differ between CRHP and CD diets, all  p ≥  .2.","['Thirty participants with T2DM', 'weight stable participants with type 2 diabetes', 'weight stable individuals with T2DM']","['carbohydrate-reduced high-protein (CRHP', 'CRHP diet', 'Carbohydrate-restricted diets', 'conventional diabetes (CD) diet', 'CRHP or CD dietary treatment (30/50 energy percentage (E%) carbohydrate, 30/17E% protein, 40/33E% fat), followed by a cross-over to the opposite diet', 'highly controlled carbohydrate-reduced high-protein diet']","['Diurnal urine samples', 'Fasting concentrations of soluble urokinase plasminogen activator receptor, high-sensitivity C-reactive protein, tumor necrosis factor alpha and interleukin-6', 'plasma inflammatory parameters', '24-hour urinary excretion of 8-oxoGuo', '8-oxodG']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0424657', 'cui_str': 'Weight steady'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0071216', 'cui_str': 'Lymphocyte antigen CD87'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0050092', 'cui_str': '8-hydroxyguanosine'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}]",30.0,0.0199666,"Changes in plasma inflammatory parameters did not differ between CRHP and CD diets, all  p ≥  .2.","[{'ForeName': 'Mads Juul', 'Initials': 'MJ', 'LastName': 'Skytte', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Amirsalar', 'Initials': 'A', 'LastName': 'Samkani', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Meinert', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Frystyk', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Henrik Enghusen', 'Initials': 'HE', 'LastName': 'Poulsen', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Henriksen', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, and Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Clinical Research Centre and the Emergency Department, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Steen Bendix', 'Initials': 'SB', 'LastName': 'Haugaard', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Thure', 'Initials': 'T', 'LastName': 'Krarup', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Emil List', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}]",Scandinavian journal of clinical and laboratory investigation,['10.1080/00365513.2020.1759137']
56,32372046,The Influence of Listening to Music on Adults with Left-behind Experience Revealed by EEG-based Connectivity.,"The human brain has a close relationship with music. Music-induced structural and functional brain changes have been demonstrated in the healthy adult. In the present study, adults with left-behind experience (ALB) were divided into two groups. The experimental group (ALB-E) took part in the music therapy experiment with three stages, including before listening to music (pre-stage), initially listening to music (mid-stage) and after listening to music (post-stage). The control group (ALB-C) did not participate in music therapy. Scalp resting-state EEGs of ALB were recorded during the three stages. We found no significant frequency change in the ALB-C group. In the ALB-E group, only the theta power spectrum was significantly different at all stages. The topographical distributions of the theta power spectrum represented change in trends from the frontal regions to the occipital regions. The result of Granger causal analysis (GCA), based on theta frequency, showed a stronger information flow from the middle frontal gyrus to the middle temporal gyrus (MFG → MTG) in the left hemisphere at the pre-stage compared to the post-stage. Additionally, the experimental group showed a weaker information flow from inferior gyrus to superior temporal gyrus (IFG → STG) in the right hemisphere at post-test stage compared to the ALB-C group. Our results demonstrate that listening to music can play a positive role on improving negative feelings for individuals with left behind experience.",2020,"Additionally, the experimental group showed a weaker information flow from inferior gyrus to superior temporal gyrus (IFG → STG) in the right hemisphere at post-test stage compared to the ALB-C group.","['Adults with Left-behind Experience Revealed by EEG-based Connectivity', 'adults with left-behind experience (ALB', 'healthy adult']",['Listening to Music'],"['Scalp resting-state EEGs of ALB', 'negative feelings', 'weaker information flow from inferior gyrus to superior temporal gyrus (IFG\u2009→\u2009STG']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0152309', 'cui_str': 'Structure of superior temporal gyrus'}]",,0.025094,"Additionally, the experimental group showed a weaker information flow from inferior gyrus to superior temporal gyrus (IFG → STG) in the right hemisphere at post-test stage compared to the ALB-C group.","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Bio-information College, ChongQing University of Posts and Telecommunications, ChongQing, 400065, China. tiany20032003@163.com.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Bio-information College, ChongQing University of Posts and Telecommunications, ChongQing, 400065, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Bio-information College, ChongQing University of Posts and Telecommunications, ChongQing, 400065, China.'}, {'ForeName': 'Sifan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Sichuan Heguang Clinical Psychology Institute, ChengDu, 610074, China.'}]",Scientific reports,['10.1038/s41598-020-64381-x']
57,32382082,High-risk additional chromosomal abnormalities at low blast counts herald death by CML.,"Blast crisis is one of the remaining challenges in chronic myeloid leukemia (CML). Whether additional chromosomal abnormalities (ACAs) enable an earlier recognition of imminent blastic proliferation and a timelier change of treatment is unknown. One thousand five hundred and ten imatinib-treated patients with Philadelphia-chromosome-positive (Ph+) CML randomized in CML-study IV were analyzed for ACA/Ph+ and blast increase. By impact on survival, ACAs were grouped into high risk (+8, +Ph, i(17q), +17, +19, +21, 3q26.2, 11q23, -7/7q abnormalities; complex) and low risk (all other). The presence of high- and low-risk ACAs was linked to six cohorts with different blast levels (1%, 5%, 10%, 15%, 20%, and 30%) in a Cox model. One hundred and twenty-three patients displayed ACA/Ph+ (8.1%), 91 were high risk. At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA. No effect was observed at blast levels of 20-30%. Sixty-three patients with high-risk ACA (69%) died (n = 37) or were alive after progression or progression-related transplantation (n = 26). High-risk ACA at low blast counts identify end-phase CML earlier than current diagnostic systems. Mortality was lower with earlier treatment. Cytogenetic monitoring is indicated when signs of progression surface or response to therapy is unsatisfactory.",2020,"At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA.","['chronic myeloid leukemia (CML', 'Sixty-three patients with high-risk ACA (69%) died (n\u2009=\u200937) or were alive after progression or progression-related transplantation (n\u2009=\u200926', 'One thousand five hundred and ten imatinib-treated patients with Philadelphia-chromosome-positive (Ph+) CML randomized in CML-study IV']",[],"['Mortality', 'survival, ACAs']","[{'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0149561', 'cui_str': 'Structure of anterior cerebral artery'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C0450407', 'cui_str': 'ph+'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}]",63.0,0.0438058,"At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA.","[{'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': 'ELN Foundation, Weinheim, Germany. hehlmann.eln@gmail.com.'}, {'ForeName': 'Astghik', 'Initials': 'A', 'LastName': 'Voskanyan', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lauseker', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pfirrmann', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Kalmanti', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Rinaldetti', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kohlbrenner', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Haferlach', 'Affiliation': 'MLL, München, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Schlegelberger', 'Affiliation': 'Institut für Humangenetik, MHH, Hannover, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Fabarius', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Seifarth', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Spieß', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wuchter', 'Affiliation': 'Institut für Transfusionsmedizin und Immunologie, Medizinische Fakultät Mannheim, Universität Heidelberg und DRK-Blutspendedienst, Mannheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Medizinische Klinik 5, Universitätsklinikum, Erlangen, Germany.'}, {'ForeName': 'Hans-Jochem', 'Initials': 'HJ', 'LastName': 'Kolb', 'Affiliation': 'Medizinische Klinik III, Universitätsklinikum Großhadern, München, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neubauer', 'Affiliation': 'Klinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.'}, {'ForeName': 'Dieter K', 'Initials': 'DK', 'LastName': 'Hossfeld', 'Affiliation': '2. Medizinische Klinik, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nerl', 'Affiliation': 'Klinikum Schwabing, München, Germany.'}, {'ForeName': 'Alois', 'Initials': 'A', 'LastName': 'Gratwohl', 'Affiliation': 'Universitätsspital, Basel, Switzerland.'}, {'ForeName': 'Gabriela M', 'Initials': 'GM', 'LastName': 'Baerlocher', 'Affiliation': 'Inselspital, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Burchert', 'Affiliation': 'Klinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.'}, {'ForeName': 'Tim H', 'Initials': 'TH', 'LastName': 'Brümmendorf', 'Affiliation': 'Uniklinik RWTH, Aachen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': 'Klinik für Innere Medizin II, Universitätsklinikum, Jena, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Saußele', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baccarani', 'Affiliation': 'Department of Hematology-Oncology, Policlinico S.Orsola-Malpighi, University of Bologna, Bologna, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0826-9']
58,32385307,Randomized controlled trial of medium cut-off versus high-flux dialyzers on quality of life outcomes in maintenance hemodialysis patients.,"Medium cut-off (MCO) dialyzers help remove larger middle molecules associated with symptoms related to the accumulation of uremic retention solutes. We investigated the effect of an MCO dialyzer on the improvement of quality of life (QOL) in maintenance hemodialysis (HD) patients. Forty-nine HD patients with high-flux dialysis were randomly assigned to either an MCO (Theranova 400, Baxter) or a high-flux (FX CorDiax 80 or 60, Fresenius Medical Care) dialyzer and completed the study. QOL was assessed at baseline and after 12 weeks of treatment using the Kidney Disease Quality of Life Short Form-36, and pruritus was assessed using a questionnaire and visual analog scale. The reduction ratios of middle molecules were also evaluated. Laboratory markers, including serum albumin, did not differ between the two groups after 12 weeks. Removals of kappa and lambda free light chains were greater for MCO dialyzer than high-flux dialyzer. The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively). MCO dialyzers may improve patient-reported outcomes, particularly the physical components of QOL and uremic pruritus, in patients with high-flux dialyzers.",2020,"The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively).","['maintenance hemodialysis (HD) patients', 'maintenance hemodialysis patients', 'patients with high-flux dialyzers', 'Forty-nine HD patients with high-flux dialysis']","['Medium cut-off (MCO) dialyzers', 'MCO dialyzer', 'MCO (Theranova 400, Baxter) or a high-flux (FX CorDiax 80 or 60, Fresenius Medical Care) dialyzer', 'medium cut-off versus high-flux dialyzers', 'MCO dialyzers', 'MCO']","['reduction ratios of middle molecules', 'serum albumin', 'Removals of kappa and lambda free light chains', 'QOL', 'quality of life (QOL', 'questionnaire and visual analog scale', 'Kidney Disease Quality of Life Short Form-36, and pruritus', 'quality of life outcomes', 'frequency of scratching during sleep']","[{'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C1720314', 'cui_str': 'Lambda'}, {'cui': 'C0806492', 'cui_str': 'Free immunoglobulin light chain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]",49.0,0.0435656,"The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively).","[{'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yeongwoo', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Statistics, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Ju-Min', 'Initials': 'JM', 'LastName': 'Yook', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Soon-Youn', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Hee-Yeon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Sun-Hee', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Chan-Duck', 'Initials': 'CD', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yong-Lim', 'Initials': 'YL', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Jang-Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea. jh-cho@knu.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-64622-z']
59,32389606,Patient-Reported Receipt of Goal-Concordant Care Among Seriously Ill Outpatients-Prevalence and Associated Factors.,"CONTEXT


Goal-concordant care is an important indicator of high-quality care in serious illness.
OBJECTIVES


To estimate the prevalence of patient-reported receipt of goal-concordant care among seriously ill outpatients and identify factors associated with the absence of patient-reported goal concordance.
METHODS


Analysis of enrollment surveys from a multicenter cluster-randomized trial of outpatients with serious illness. Patients reported their prioritized health care goal and the focus of their current medical care; these items were matched to define receipt of goal-concordant care.
RESULTS


Of 405 patients with a prioritized health care goal, 58% reported receipt of goal-concordant care, 17% goal-discordant care, and 25% were uncertain of the focus of their care. Patient-reported receipt of goal concordance differed by patient goal. For patients who prioritized extending life, 86% reported goal-concordant care, 2% goal-discordant care, and 12% were uncertain of the focus of their care. For patients who prioritized relief of pain and discomfort, 51% reported goal-concordant care, 21% goal-discordant care, and 28% were uncertain of the focus of their care. Patients who prioritized a goal of relief of pain and discomfort were more likely to report goal-discordant care than patients who prioritized a goal of extending life (relative risk ratio 22.20; 95% CI 4.59, 107.38).
CONCLUSION


Seriously ill outpatients who prioritize a goal of relief of pain and discomfort are less likely to report receipt of goal-concordant care than patients who prioritize extending life. Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.",2020,Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.,"['patients who prioritize relief of pain and discomfort and promoting care aligned with that goal', 'Analysis of enrollment surveys from a multi-center cluster-randomized trial of outpatients with serious illness', '405 patients with a prioritized healthcare goal']",[],['pain and discomfort'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",405.0,0.0464339,Future interventions designed to improve receipt of goal-concordant care should focus on identifying patients who prioritize relief of pain and discomfort and promoting care aligned with that goal.,"[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Modes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA. Electronic address: modes@uw.edu.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Heckbert', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Engelberg', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Nielsen', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA; Department of Bioethics and Humanities, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Kross', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA; Cambia Palliative Care Center of Excellence, University of Washington, Seattle, Washington, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.04.026']
60,32333853,Evaluation of Venous Thromboembolism Recurrence Scores in an Unprovoked Pulmonary Embolism Population: A Post-hoc Analysis of the PADIS-PE trial.,"BACKGROUND


We aimed to validate the Men Continue and HERDOO2 (HERDOO2), D-dimer, age, sex, hormonal therapy (DASH), and updated Vienna recurrent venous thromboembolism prediction models in a population composed entirely of first unprovoked pulmonary embolism, and to analyze the impact of the addition of the pulmonary vascular obstruction index (PVOI) on score accuracy.
METHODS


Analyses were based on the double-blind, randomized PADIS-PE trial, which included 371 unprovoked pulmonary embolism patients initially treated for 6 months, successively randomized to receive an additional 18 months of warfarin or placebo, and subsequently followed-up for 2 years.
RESULTS


The HERDOO2, DASH, and updated Vienna scores displayed C-statistics of 0.61 (95% CI 0.54-0.68), 0.60 (95% CI 0.53-0.66), and 0.58 (95% CI 0.51-0.66), respectively. Only the HERDOO2 score identified low recurrence risk patients (<3%/year) after anticoagulation was stopped. When added to either of the prediction models, PVOI measured at pulmonary embolism diagnosis, after 6 months of anticoagulation, or both, improved scores' C-statistics between +0.06 and +0.11 points and consistently led to identifying at least 50% of patients who experienced recurrence but in whom the scores would have indicated against extended anticoagulation.
CONCLUSIONS


In patients with a first unprovoked pulmonary embolism, the HERDOO2 score is able to identify patients with a low recurrence risk after treatment discontinuation. Addition of PVOI improves accuracy of all scores.
CLINICAL TRIALS REGISTRATION


URL: http://www.controlled-trials.com. Unique identifier: NCT00740883.",2020,"The HERDOO2, DASH and Updated Vienna scores displayed c-statistics of 0.61 (95%CI 0.54-0.68), 0.60 (95%CI 0.53-0.66) and 0.58 (95%CI 0.51-0.66) respectively.",['371 unprovoked pulmonary embolism patients initially treated during 6 months'],"['PVOI', 'warfarin or placebo']",['Venous Thromboembolism Recurrence Scores'],"[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",371.0,0.625721,"The HERDOO2, DASH and Updated Vienna scores displayed c-statistics of 0.61 (95%CI 0.54-0.68), 0.60 (95%CI 0.53-0.66) and 0.58 (95%CI 0.51-0.66) respectively.","[{'ForeName': 'Leela', 'Initials': 'L', 'LastName': 'Raj', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Presles', 'Affiliation': 'Unité de Recherche Clinique, Innovation et Pharmacologie, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Le Mao', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Robin', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sanchez', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Université Paris Descartes, Université Sorbonne Paris Cité, France; Service de Pneumologie et de Soins intensifs, Hôpital Européen Georges Pompidou, AP-HP, Paris, France; INSERM UMR S 1140, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pernod', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Département de Médecine Vasculaire, Centre Hospitalo-Universitaire de Grenoble, Université de Grenoble 1, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bertoletti', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jego', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Interne, Centre Hospitalo-Universitaire de Rennes, Université de Rennes 1, France.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Lemarié', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Leven', 'Affiliation': 'Service de Cardiologie and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': ""Service d'Echo-doppler Vasculaire, and EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Planquette', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Université Paris Descartes, Université Sorbonne Paris Cité, France; Service de Pneumologie et de Soins intensifs, Hôpital Européen Georges Pompidou, AP-HP, Paris, France; INSERM UMR S 1140, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Le Roux', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Slaun', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Nonent', 'Affiliation': 'Service de Radiologie, and EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Girard', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Département Thoracique, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Lacut', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Solen', 'Initials': 'S', 'LastName': 'Mélac', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Guégan', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mismetti', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France.'}, {'ForeName': 'Silvy', 'Initials': 'S', 'LastName': 'Laporte', 'Affiliation': 'Unité de Recherche Clinique, Innovation et Pharmacologie, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Université Paris Descartes, Université Sorbonne Paris Cité, France; Service de Pneumologie et de Soins intensifs, Hôpital Européen Georges Pompidou, AP-HP, Paris, France; INSERM UMR S 1140, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leroyer', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tromeur', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France. Electronic address: francis.couturaud@chu-brest.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.03.040']
61,30650418,"Can Early Introduction of Palliative Care Limit Intensive Care, Emergency and Hospital Admissions in Patients with Severe Chronic Obstructive Pulmonary Disease? A Pilot Randomized Study.","BACKGROUND


Despite their poor prognosis, patients with severe chronic obstructive pulmonary disease (COPD) have little access to palliative care and tend to have a high rate of hospital and intensive care unit (ICU) admissions during their last year of life.
OBJECTIVES


To determine the feasibility of a home palliative care intervention during 1 year versus usual care, and the possible impact of this intervention on emergency, hospital and ICU admissions, survival, mood, and health-related quality of life (HRQL).
METHODS


Prospective controlled study of patients with severe COPD (GOLD stage III or IV) and long-term oxygen therapy and/or home noninvasive ventilation and/or one or more hospital admissions in the previous year for acute exacerbation, randomized to usual care versus usual care with add-on monthly intervention by palliative care specialists at home for 12 months.
RESULTS


Of 315 patients screened, 49 (15.5%) were randomized (26 to early palliative care; 23 to the control group); aged (mean ± SD) 71 ± 8 years; FEV1 was 37 ± 14% predicted; 88% with a COPD assessment test score > 10; 69% on long-term oxygen therapy or home noninvasive ventilation. The patients accepted the intervention and completed the assessment scales. After 1 year, there was no difference between groups in symptoms, HRQL and mood, and there was a nonsignificant trend for higher admission rates to hospital and emergency wards in the intervention group.
CONCLUSION


Although this pilot study was underpowered to formally exclude a benefit from palliative care in severe COPD, it raises several questions as to patient selection, reluctance to palliative care in this group, and modalities of future trials.",2019,"After 1 year, there was no difference between groups in symptoms, HRQL and mood, and there was a nonsignificant trend for higher admission rates to hospital and emergency wards in the intervention group.
","['patients with severe chronic obstructive pulmonary disease (COPD', 'Patients with Severe Chronic Obstructive Pulmonary Disease', 'patients with severe COPD (GOLD stage III or IV) and long-term oxygen therapy and/or home noninvasive ventilation and/or one or more hospital admissions in the previous year for acute exacerbation, randomized to', 'Of 315 patients screened, 49 (15.5%) were randomized (26 to early palliative care; 23 to the control group); aged (mean ± SD) 71 ± 8 years; FEV1 was 37 ± 14% predicted; 88% with a COPD assessment test score > 10; 69% on']","['home palliative care intervention', 'usual care versus usual care with add-on monthly intervention by palliative care specialists at home for 12 months', 'long-term oxygen therapy or home noninvasive ventilation']","['symptoms, HRQL and mood', 'emergency, hospital and ICU admissions, survival, mood, and health-related quality of life (HRQL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0418996', 'cui_str': 'Ltot - long-term oxygen therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0418996', 'cui_str': 'Ltot - long-term oxygen therapy'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0984953,"After 1 year, there was no difference between groups in symptoms, HRQL and mood, and there was a nonsignificant trend for higher admission rates to hospital and emergency wards in the intervention group.
","[{'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Janssens', 'Affiliation': 'Division of Pulmonary Diseases, Department of Medical Specialties, Geneva University Hospitals, Geneva, Switzerland, Jean-Paul.Janssens@hcuge.ch.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Weber', 'Affiliation': 'Department of Community Medicine, Primary Care, and Emergency, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'François R', 'Initials': 'FR', 'LastName': 'Herrmann', 'Affiliation': 'Division of Geriatrics, Department of Internal Medicine, Rehabilitation and Geriatrics, Geneva University Hospitals and University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Cantero', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Rehabilitation and Geriatrics, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Pessina', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Rehabilitation and Geriatrics, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Matis', 'Affiliation': 'Department of Palliative Care and Rehabilitation, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Roselyne', 'Initials': 'R', 'LastName': 'Merlet Viollet', 'Affiliation': 'Center for Clinical Research, Department of Anesthesiology, Pharmacology, and Intensive Care, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Ludivine', 'Initials': 'L', 'LastName': 'Boiche-Brouillard', 'Affiliation': 'Department of Palliative Care and Rehabilitation, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Jerôme', 'Initials': 'J', 'LastName': 'Stirnemann', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Rehabilitation and Geriatrics, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pautex', 'Affiliation': 'Department of Community Medicine, Primary Care, and Emergency, Geneva University Hospitals, Geneva, Switzerland.'}]",Respiration; international review of thoracic diseases,['10.1159/000495312']
62,31952851,Is It Time for a Randomized Controlled Trial of Hypothermia for Mild Hypoxic-Ischemic Encephalopathy?,,2020,,[],['Hypothermia'],[],[],"[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}]",[],,0.157476,,"[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI.'}, {'ForeName': 'Sara V', 'Initials': 'SV', 'LastName': 'Bates', 'Affiliation': 'Department of Pediatrics, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Seetha', 'Initials': 'S', 'LastName': 'Shankaran', 'Affiliation': 'Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI. Electronic address: sshankar@med.wayne.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.11.030']
63,31986459,Gluteus medius dysfunction in females with chronic ankle instability is consistent at different walking speeds.,"BACKGROUND


Patients with chronic ankle instability often present with altered gait mechanics compared to ankle sprain copers. There is increasing evidence to suggest proximal neuromuscular alterations contribute to the injury etiology, however little is known about how these changes manifest during gait. The purpose of this study was to investigate ipsilateral gluteus maximus and medius functional activity ratios throughout treadmill walking at three speeds (preferred, 120% preferred, and 1.35 m per second) in chronic ankle instability patients compared to copers.
METHODS


28 females (14 chronic ankle instability, 14 copers) walked at the three gait speeds in randomized order. Ground reaction forces and 10-s gluteal ultrasound clips were simultaneously recorded. Clips were reduced using ground reaction forces to extract 55 measurement frames. Normalized gluteal thickness measures were used to determine functional activity ratios. 2 × 3 analyses of variance were run to assess group and speed effects on gluteal outcomes throughout walking using statistical parametric mapping. Post-hoc t-tests, mean differences, and Cohen's d effect sizes were assessed for significant findings (P ≤ .05).
FINDINGS


The chronic ankle instability group had significantly decreased gluteus medius activity throughout the entire gait cycle when compared to the coper group, independent of gait speed (P < .001, mean differences: 0.10-0.18; d: 1.00-3.17). There were no significant group or speed main effects, nor an interaction for gluteus maximus activity.
INTERPRETATION


Gluteal dysfunction throughout walking was identified in chronic ankle instability. The coper group remained within healthy reference muscle activity ranges, suggesting that proximal muscle activation alterations are associated chronic ankle impairments.",2020,"There were no significant group or speed main effects, nor an interaction for gluteus maximus activity.
","['chronic ankle instability patients', '28 females (14 chronic ankle instability, 14 copers) walked at the three gait speeds in randomized order', 'females with chronic ankle instability']",[],"['functional activity ratios', 'ipsilateral gluteus maximus and medius functional activity ratios', 'gait speed', 'Normalized gluteal thickness measures', 'chronic ankle impairments', 'gluteus medius activity']","[{'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]",,0.026058,"There were no significant group or speed main effects, nor an interaction for gluteus maximus activity.
","[{'ForeName': 'Alexandra F', 'Initials': 'AF', 'LastName': 'DeJong', 'Affiliation': 'University of Virginia, Exercise and Sports Injury Lab, 210 Emmet Street South, Charlottesville, VA 22904-4407, USA. Electronic address: afd4au@virginia.edu.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Koldenhoven', 'Affiliation': 'Texas State University, Biomechanics/Sports Medicine Lab, 601 University Drive, San Marcos, TX 78666-4616, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Hart', 'Affiliation': 'University of Virginia, Exercise and Sports Injury Lab, 210 Emmet Street South, Charlottesville, VA 22904-4407, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hertel', 'Affiliation': 'University of Virginia, Exercise and Sports Injury Lab, 210 Emmet Street South, Charlottesville, VA 22904-4407, USA.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.01.013']
64,32192020,Impact of 12-Month Smartphone Breathing Meditation Program upon Systolic Blood Pressure among Non-Medicated Stage 1 Hypertensive Adults.,"(1) Background: Hypertension (HTN) affects ~50% of adults and is a major risk factor for stroke and cardiovascular disease. In 2017, the SPRINT trial outcomes led to lowering of HTN cutoffs by the American College of Cardiology (ACC) and American Heart Association (AHA). The Joint National Committee (JNC8) and National High BP Education Program recommend that lifestyle modifications be used as first-line HTN treatment. Chronic stress is a risk factor for HTN and cardiovascular disease. A recently completed 12 month randomized controlled trial (RCT) of a breathing meditation smart phone app (Tension Tamer, TT) involving JNC8 designated pre-HTN adults provided an opportunity to examine its impact upon individuals now classified as having stage 1 HTN. The TT app captures continuous real-time heart rate (HR) from a user's fingertip placed over a video camera lens during sessions. Users receive immediate feedback graphs after each session, showing their HR changes. They also receive motivational and social reinforcement SMS text messages the following day based upon levels of adherence. We conducted ancillary analyses of a 2-arm, 12-month, small-scale efficacy RCT among a subgroup of our total sample of participants, who are now classified as having stage 1 non-medicated systolic HTN. Primary outcome was change in resting systolic blood pressure (SBP). Secondary outcomes were change in resting diastolic blood pressure, adherence to the TT protocol, and perceived stress levels. (2) Methods: 30 adults (mean age: 45.0 years; 15 males; 16 White; 14 Black) with ACC/AHA 2017 defined systolic HTN (130-139 mmHg) on 3 consecutive sessions (mean SBP: 132.6 mmHg) were randomly assigned to TT or lifestyle education program delivered via smartphone (SPCTL). Each group received a twice-daily dosage schedule of TT or walking (month 1: 15 min; months 2 and 3: 10 min; months 4-12: 5 min). (3) Results: Mixed modeling results revealed a significant group x time effect for SBP (p<.01). The TT group showed greater SBP reductions at months 3 (-8.0 vs. -1.9), 6 (-10.0 vs. -0.7), and 12: (-11.6 vs. -0.4 mmHg; all  p -values <0.04). (4) Conclusion: The TT app was beneficial in reducing SBP levels among adults with stage 1 systolic HTN. The TT app may be a promising, scalable first-line tactic for stage 1 HTN. Preparations are underway for an efficacy RCT involving uncontrolled stage 1 HTN patients.",2020,"The TT group showed greater SBP reductions at months 3 (-8.0 vs. -1.9), 6","['2) Methods: 30 adults (mean age: 45.0 years; 15 males; 16 White; 14 Black) with ACC/AHA 2017 defined systolic HTN (130-139 mmHg) on 3 consecutive sessions (mean SBP: 132.6 mmHg', 'Non', 'a subgroup of our total sample of participants, who are now classified as having stage 1 non-medicated systolic HTN', 'adults with stage 1 systolic HTN', 'Medicated Stage 1 Hypertensive Adults']","['breathing meditation smart phone app (Tension Tamer, TT) involving JNC8 designated pre-HTN adults', 'Smartphone Breathing Meditation Program', 'TT or lifestyle education program delivered via smartphone (SPCTL']","['SBP levels', 'lowering of HTN cutoffs by the American College of Cardiology (ACC) and American Heart Association (AHA', 'resting systolic blood pressure (SBP', 'Systolic Blood Pressure', 'SBP reductions', 'resting diastolic blood pressure, adherence to the TT protocol, and perceived stress levels']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0150277'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",,0.0940947,"The TT group showed greater SBP reductions at months 3 (-8.0 vs. -1.9), 6","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chandler', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Sox', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Diaz', 'Affiliation': 'College of Medicine, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Kinsey', 'Initials': 'K', 'LastName': 'Kellam', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Neely', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Nemeth', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Treiber', 'Affiliation': 'College of Nursing, Medical University of South Carolina, Charleston, WV 29425, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17061955']
65,32306943,"Effectiveness of the Healthy Start-Départ Santé approach on physical activity, healthy eating and fundamental movement skills of preschoolers attending childcare centres: a randomized controlled trial.","BACKGROUND


Since young children spend approximately 30 h per week in early childcare centres (ECC), this setting is ideal to foster healthy behaviours. This study aimed to assess the effectiveness of the Healthy Start-Départ Santé (HSDS) randomized controlled trial in increasing physical activity (PA) levels and improving healthy eating and fundamental movement skills in preschoolers attending ECC.
METHODS


Sixty-one ECC were randomly selected and allocated to either the usual practice (n = 30; n = 433 children) or intervention group (n = 31; n = 464 children). The HSDS intervention group was provided a 3-h on-site training for childcare educators which aimed to increase their knowledge and self-efficacy in promoting healthy eating, PA and development of fundamental movement skills in preschoolers. PA was measured during childcare hours for five consecutive days using the Actical accelerometer. Preschoolers' fundamental movement skills were assessed using the standard TGMD-II protocol and POMP scores. Food intake was evaluated using digital photography-assisted weighted plate waste at lunch, over two consecutive days. All data were collected prior to the HSDS intervention and again 9 months later. Mixed-effect models were used to analyse the effectiveness of the HSDS intervention on all outcome measures.
RESULTS


Total number of children who provided valid data at baseline and endpoint for PA, food intake and fundamental movement skills were 259, 670 and 492, respectively. Children in the HSDS intervention group had, on average, a 3.33 greater point increase in their locomotor motor skills scores than children in the control group (β = 3.33, p = 0.009). No significant differences in effects were observed for object control, PA and food intake. However, results demonstrated a marginal increase in portions of fruits and vegetables served in the intervention group compared to control group (β = 0.06, p = 0.05).
CONCLUSION


Of the 12 outcome variables investigated in this study, 10 were not different between the study groups and two of them (locomotor skills and vegetables and fruits servings) showed a significant improvement. This suggests that HSDS is an effective intervention for the promotion of some healthy behaviours among preschoolers attending ECC.
TRIAL REGISTRATION


Clinical Trials NCT02375490. Registered on February 24, 2015; 77 retrospectively registered.",2020,"Children in the HSDS intervention group had, on average, a 3.33 greater point increase in their locomotor motor skills scores than children in the control group (β = 3.33, p = 0.009).","['preschoolers attending ECC', 'Sixty-one ECC', 'preschoolers attending childcare centres', 'Registered on February 24, 2015; 77 retrospectively registered']","['Healthy Start-Départ Santé approach', 'Healthy Start-Départ Santé (HSDS', 'HSDS', 'HSDS intervention', 'usual practice (n\u2009=\u200930; n\u2009=\u2009433 children) or intervention group']","['portions of fruits and vegetables', 'object control, PA and food intake', 'physical activity (PA) levels', 'PA, food intake and fundamental movement skills', 'healthy eating and fundamental movement skills', ""Preschoolers' fundamental movement skills"", 'PA', 'locomotor motor skills scores', 'physical activity, healthy eating and fundamental movement skills', 'standard TGMD-II protocol and POMP scores']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0071715', 'cui_str': 'POMP protocol'}]",61.0,0.0461706,"Children in the HSDS intervention group had, on average, a 3.33 greater point increase in their locomotor motor skills scores than children in the control group (β = 3.33, p = 0.009).","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Leis', 'Affiliation': 'Department of Community Health & Epidemiology, College of Medicine, University of Saskatchewan, Health Sciences E Wing, 104, Clinic Place, Saskatoon, SK, S7N 5E5, Canada. anne.leis@usask.ca.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ward', 'Affiliation': ""École des sciences des aliments, de nutrition et d'études familiales, Faculté des sciences de la santé et des services communautaires, Université de Moncton, Moncton, Canada.""}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Vatanparast', 'Affiliation': 'College of Pharmacy and Nutrition/School of Public Health, University of Saskatchewan, Saskatoon, Saskatchewan, S7N 0Z2, Canada.'}, {'ForeName': 'M Louise', 'Initials': 'ML', 'LastName': 'Humbert', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Amanda Froehlich', 'Initials': 'AF', 'LastName': 'Chow', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Nazeem', 'Initials': 'N', 'LastName': 'Muhajarine', 'Affiliation': 'Department of Community Health & Epidemiology, College of Medicine, University of Saskatchewan, Health Sciences E Wing, 104, Clinic Place, Saskatoon, SK, S7N 5E5, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Engler-Stringer', 'Affiliation': 'Department of Community Health & Epidemiology, College of Medicine, University of Saskatchewan, Health Sciences E Wing, 104, Clinic Place, Saskatoon, SK, S7N 5E5, Canada.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Bélanger', 'Affiliation': 'Department of family medicine, Université de Sherbrooke, 18 avenue Antonine-Maillet Moncton, Moncton, New Brunswick, E1A 3E9, Canada.'}]",BMC public health,['10.1186/s12889-020-08621-9']
66,31239236,Is There Still a Need for Repeated Systematic Biopsies in Patients with Previous Negative Biopsies in the Era of Magnetic Resonance Imaging-targeted Biopsies of the Prostate?,"BACKGROUND


The role of targeted prostate biopsies (TBs) in patients with cancer suspicious lesions on multiparametric magnetic resonance imaging (mpMRI) following negative systematic biopsies (SBs) is undebated. However, whether they should be combined with repeated SBs remains unclear.
OBJECTIVE


To evaluate the value of repeated SBs in addition to TBs in patients with a prior negative SB and a persistent suspicion of prostate cancer (PCa).
DESIGN, SETTING, AND PARTICIPANTS


A prospective study as part of a multicenter randomized controlled trial conducted between 2014 and 2017, including 665 men with a prior negative SB and a persistent suspicion of PCa (suspicious digital rectal examination and/or prostate-specific antigen >4.0ng/ml).
INTERVENTION


All patients underwent 3T mpMRI according to Prostate Imaging Reporting and Data System (PI-RADS) v2. Patients with PI-RADS ≥3 were randomized 1:1:1 for three TB techniques: MRI-TRUS fusion TB (FUS-TB), cognitive registration fusion TB (COG-TB), or in-bore MRI TB. FUS-TB and COG-TB were combined with repeated SBs.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Clinically significant prostate cancer (csPCa) was defined as Gleason ≥3+4. Differences in detection rates of csPCa, clinically insignificant PCa (cisPCa), and overall PCa between TBs (FUS-TB and COG-TB) and repeated SBs were compared using McNemar's test.
RESULTS AND LIMITATIONS


In the 152 patients who underwent both TB and SB, PCa was detected by TB in 47% and by SB in 32% (p<0.001, 95% confidence interval [CI]: 6.0-22%). TB detected significantly more csPCa than SB (32% vs 16%; p<0.001, 95% CI: 11-25%). Clinically significant PCa was missed by TB in 1.3% (2/152). Combining SB and TB resulted in detection rate differences of 6.0% for PCa, 5.0% for cisPCa, and 1.0% for csPCa compared with TB alone.
CONCLUSIONS


In case of a persistent suspicion of PCa following a negative SB, TB detected significantly more csPCa cases than SB. The additional value of SB was limited, and only 1.3% of csPCa would have been missed when SB had been omitted.
PATIENT SUMMARY


We evaluated the role of systematic biopsies and magnetic resonance imaging (MRI)-targeted biopsies for the diagnosis of prostate cancer in patients with prior negative systematic biopsies. MRI-targeted biopsies perform better in detecting prostate cancer in these patients. The value of repeated systematic biopsies is limited.",2020,"TB detected significantly more csPCa than SB (32% vs 16%; p<0.001, 95% CI: 11-25%).","['Patients with PI-RADS ≥3', '2014 and 2017, including 665 men with a prior negative SB and a persistent suspicion of PCa (suspicious digital rectal examination', 'patients with a prior negative SB and a persistent suspicion of prostate cancer (PCa', 'patients with prior negative systematic biopsies', 'Patients with Previous Negative Biopsies in the Era of Magnetic Resonance Imaging-targeted Biopsies of the Prostate', 'patients with cancer suspicious lesions']","['targeted prostate biopsies (TBs', 'multiparametric magnetic resonance imaging (mpMRI) following negative systematic biopsies (SBs', 'systematic biopsies and magnetic resonance imaging (MRI)-targeted biopsies']","['detection rate differences', 'detection rates of csPCa, clinically insignificant PCa (cisPCa), and overall PCa between TBs (FUS-TB and COG-TB) and repeated SBs', 'prostate cancer (csPCa']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517848', 'cui_str': '665'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C1384593', 'cui_str': 'Digital Rectal Examination'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0220922', 'cui_str': 'systematics'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",,0.273658,"TB detected significantly more csPCa than SB (32% vs 16%; p<0.001, 95% CI: 11-25%).","[{'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Exterkate', 'Affiliation': 'Department of Urology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands. Electronic address: l.exterkate@cwz.nl.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Wegelin', 'Affiliation': 'Department of Urology, St. Antonius Hospital, Nieuwegein/Utrecht, The Netherlands.'}, {'ForeName': 'Jelle O', 'Initials': 'JO', 'LastName': 'Barentsz', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc Nijmegen, The Netherlands.'}, {'ForeName': 'Marloes G', 'Initials': 'MG', 'LastName': 'van der Leest', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc Nijmegen, The Netherlands.'}, {'ForeName': 'J Alain', 'Initials': 'JA', 'LastName': 'Kummer', 'Affiliation': 'Department of Pathology, St. Antonius Hospital, Nieuwegein/Utrecht, The Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Vreuls', 'Affiliation': 'Department of Pathology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'de Bruin', 'Affiliation': 'Department of Pathology, St. Antonius Hospital, Nieuwegein/Utrecht, The Netherlands.'}, {'ForeName': 'J L H Ruud', 'Initials': 'JLHR', 'LastName': 'Bosch', 'Affiliation': 'Department of Oncologic Urology, UMC, Utrecht, The Netherlands.'}, {'ForeName': 'Harm H E', 'Initials': 'HHE', 'LastName': 'van Melick', 'Affiliation': 'Department of Urology, St. Antonius Hospital, Nieuwegein/Utrecht, The Netherlands.'}, {'ForeName': 'Diederik M', 'Initials': 'DM', 'LastName': 'Somford', 'Affiliation': 'Department of Urology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands.'}]",European urology oncology,['10.1016/j.euo.2019.06.005']
67,32219386,Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes.,"Importance


Additional treatments are needed for heart failure with reduced ejection fraction (HFrEF). Sodium-glucose cotransporter 2 (SGLT2) inhibitors may be an effective treatment for patients with HFrEF, even those without diabetes.
Objective


To evaluate the effects of dapagliflozin in patients with HFrEF with and without diabetes.
Design, Setting, and Participants


Exploratory analysis of a phase 3 randomized trial conducted at 410 sites in 20 countries. Patients with New York Heart Association classification II to IV with an ejection fraction less than or equal to 40% and elevated plasma N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019.
Interventions


Addition of once-daily 10 mg of dapagliflozin or placebo to recommended therapy.
Main Outcomes and Measures


The primary outcome was the composite of an episode of worsening heart failure or cardiovascular death. This outcome was analyzed by baseline diabetes status and, in patients without diabetes, by glycated hemoglobin level less than 5.7% vs greater than or equal to 5.7%.
Results


Among 4744 patients randomized (mean age, 66 years; 1109 [23%] women; 2605 [55%] without diabetes), 4742 completed the trial. Among participants without diabetes, the primary outcome occurred in 171 of 1298 (13.2%) in the dapagliflozin group and 231 of 1307 (17.7%) in the placebo group (hazard ratio, 0.73 [95% CI, 0.60-0.88]). In patients with diabetes, the primary outcome occurred in 215 of 1075 (20.0%) in the dapagliflozin group and 271 of 1064 (25.5%) in the placebo group (hazard ratio, 0.75 [95% CI, 0.63-0.90]) (P value for interaction = .80). Among patients without diabetes and a glycated hemoglobin level less than 5.7%, the primary outcome occurred in 53 of 438 patients (12.1%) in the dapagliflozin group and 71 of 419 (16.9%) in the placebo group (hazard ratio, 0.67 [95% CI, 0.47-0.96]). In patients with a glycated hemoglobin of at least 5.7%, the primary outcome occurred in 118 of 860 patients (13.7%) in the dapagliflozin group and 160 of 888 (18.0%) in the placebo group (hazard ratio, 0.74 [95% CI, 0.59-0.94]) (P value for interaction = .72). Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes. A kidney adverse event was reported in 4.8% of patients in the dapagliflozin group and 6.0% in the placebo group among patients without diabetes and in 8.5% of patients in the dapagliflozin group and 8.7% in the placebo group among patients with diabetes.
Conclusions and Relevance


In this exploratory analysis of a randomized trial of patients with HFrEF, dapagliflozin compared with placebo, when added to recommended therapy, significantly reduced the risk of worsening heart failure or cardiovascular death independently of diabetes status.
Trial Registration


ClinicalTrials.gov Identifier: NCT03036124.",2020,Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes.,"['than 5.7% vs greater than or equal to 5.7', 'Patients With Heart Failure', '4744 patients randomized (mean age, 66 years; 1109 [23%] women; 2605 [55%] without diabetes), 4742 completed the trial', 'patients with', 'Participants\n\n\nExploratory analysis of a phase 3 randomized trial conducted at 410 sites in 20 countries', 'patients with HFrEF with and without diabetes', 'patients with HFrEF, even those without diabetes', 'Patients with New York Heart Association classification II to IV with an ejection fraction less than or equal to 40% and elevated plasma N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019']","['HFrEF, dapagliflozin', 'Dapagliflozin', 'placebo', 'dapagliflozin or placebo', 'dapagliflozin', 'Sodium-glucose cotransporter 2 (SGLT2) inhibitors']","['glycated hemoglobin', 'adverse event', 'glycated hemoglobin level less', 'kidney adverse event', 'risk of worsening heart failure or cardiovascular death independently of diabetes status', 'composite of an episode of worsening heart failure or cardiovascular death', 'Volume depletion', 'glycated hemoglobin level', 'Worsening Heart Failure and Cardiovascular Death']","[{'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}]",4744.0,0.292236,Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes.,"[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Belohlávek', 'Affiliation': 'Second Department of Internal Medicine, Cardiovascular Medicine, General Teaching Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Medicine, Saarland University Hospital, Homburg/Saar, Germany.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'Division of Cardiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Medanta, Gurgaon, Haryana, India.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Diez', 'Affiliation': 'Division of Cardiology, Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Drozdz', 'Affiliation': 'Department Cardiology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': 'Fifth Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Disease, Department of Cardiology, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Howlett', 'Affiliation': 'Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Institute of Medicine, Department of Molecular and Clinical Medicine/Cardiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Department of Cardiology, Montreal Heart Institute, Montreal, Ontario, Canada.'}, {'ForeName': 'Pham Nguyen', 'Initials': 'PN', 'LastName': 'Vinh', 'Affiliation': 'Department of Internal Medicine, Tan Tao University, Tan Duc, Vietnam.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Gentofte University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""St Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Early Discovery and Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boulton', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}]",JAMA,['10.1001/jama.2020.1906']
68,32376984,"Different exercise training modalities produce similar endothelial function improvements in individuals with prehypertension or hypertension: a randomized clinical trial Exercise, endothelium and blood pressure.","Endothelial dysfunction is a characteristic of systemic arterial hypertension (SAH) and an early marker of atherosclerosis. Aerobic exercise training (AT) improves endothelial function. However, the effects of resistance training (RT) and combined training (CT) on endothelial function remain controversial in individuals with SAH. We determined the effects of AT, RT, and CT on endothelial function and systolic (SBP)/diastolic blood pressure (DBP) in individuals with prehypertension or hypertension. Forty-two participants (54 ± 11 y, resting SBP/DBP 137 ± 9/86 ± 6 mmHg) were randomly allocated into AT (n = 14, 40 min of cycling, 50-75% heart rate reserve), RT (n = 14, 6 resistance exercises, 4 × 12 repetitions, 60% maximum strength) and CT (n = 14, 2 × 12 repetitions of RT + 20 min of AT). All participants performed a 40-minute exercise session twice a week for 8 weeks. Endothelial function was evaluated by brachial artery flow-mediated dilation (FMD). Blood pressure was evaluated through ambulatory monitoring for 24 hours. After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT. All 3 exercise training modalities produced similar improvements in FMD: + 3.2% (95%CI 1.7, 4.6) (p < 0.001) in AT; + 4.0% (95%CI 2.1, 5.7) (p < 0.001) in RT; and +6.8% (95%CI 2.6, 11.1) (p = 0.006) in CT. In conclusion, different exercise training modalities were similarly effective in improving endothelial function but impacts on ambulatory blood pressure appear to be variable in individuals with prehypertension or hypertension.",2020,"After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT.","['Forty-two participants (54\u2009±\u200911\u2009y, resting SBP/DBP 137\u2009±\u20099/86\u2009±\u20096\u2009mmHg', 'individuals with SAH', 'individuals with prehypertension or hypertension']","['AT, RT, and CT', '40-minute exercise session', 'exercise training modalities', 'Aerobic exercise training (AT', 'resistance training (RT) and combined training (CT']","['endothelial function', 'Endothelial function', 'blood pressure', 'endothelial function and systolic (SBP)/diastolic blood pressure (DBP', 'ambulatory blood pressure', 'brachial artery flow-mediated dilation (FMD', 'FMD', 'Blood pressure', 'endothelial function improvements']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",,0.0337369,"After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT.","[{'ForeName': 'Marinei L', 'Initials': 'ML', 'LastName': 'Pedralli', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Marschner', 'Affiliation': 'Thyroid Section, Endocrine Division, Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Kollet', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Salvador G', 'Initials': 'SG', 'LastName': 'Neto', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Eibel', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Aging Research Laboratory, Department of Kinesiology & Health Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alexandre M', 'Initials': 'AM', 'LastName': 'Lehnen', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil. amlehnen@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-64365-x']
69,32379629,Effectiveness of Kinesio taping in the treatment of somatosensory tinnitus: A randomized controlled trial.,"BACKGROUND AND PURPOSE


The clinical effects of Kinesio taping (KT) for somatosensory tinnitus have not been confirmed. The purpose of this study is to investigate the efficacy of KT applied to the sternocleidomastoid, upper trapezius, and levator scapulae muscles for somatosensory tinnitus associated with neck complaints.
MATERIALS AND METHODS


Thirty-patients were randomly assigned to the KT group (n = 15) and the sham-taping (ST) group (n = 15). Tinnitus-severity was measured using a visual analog scale (tinnitus-VAS) as a primary outcome. Tinnitus Handicap Inventory (THI), cervical pain-VAS, and neck disability index (NDI) were used for the assessments of tinnitus handicap, neck pain, and disability.
RESULTS


Tinnitus-VAS, THI, cervical pain-VAS, and NDI improved significantly in the KT group after the intervention (all P ≤ 0.001). In the ST group, no significant differences in outcome measures were found in the fourth-week.
CONCLUSION


KT is more effective than sham-taping in improving somatosensory tinnitus associated with neck complaints.",2020,"RESULTS


Tinnitus-VAS, THI, cervical pain-VAS, and NDI improved significantly in the KT group after the intervention (all P ≤ 0.001).","['Thirty-patients', 'somatosensory tinnitus']","['Kinesio taping', 'sham-taping (ST', 'KT', 'Kinesio taping (KT']","['visual analog scale (tinnitus-VAS', 'Tinnitus-severity', 'Tinnitus Handicap Inventory (THI), cervical pain-VAS, and neck disability index (NDI', 'tinnitus handicap, neck pain, and disability', 'Tinnitus-VAS, THI, cervical pain-VAS, and NDI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",15.0,0.0890747,"RESULTS


Tinnitus-VAS, THI, cervical pain-VAS, and NDI improved significantly in the KT group after the intervention (all P ≤ 0.001).","[{'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Atan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Hitit University, Corum, Turkey. Electronic address: tubaatan@gmail.com.'}, {'ForeName': 'Doğan', 'Initials': 'D', 'LastName': 'Atan', 'Affiliation': 'Department of Otorhinolaryngology, Faculty of Medicine, Hitit University, Corum, Turkey.'}, {'ForeName': 'Sumru', 'Initials': 'S', 'LastName': 'Özel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Hitit University, Corum, Turkey.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101100']
70,32335058,Static and Dynamic Factors Associated With Extended Depth of Focus in Monofocal Intraocular Lenses.,"PURPOSE


To analyze factors affecting depth of focus (DOF) and near vision functionality in eyes implanted with aspheric monofocal intraocular lenses (IOLs).
METHODS


This prospective study included 111 eyes of 74 patients that underwent phacoemulsification with monofocal IOL implantation. Ninety-one normal eyes were randomized to receive aberration-free (n = 30) or negative-spherical aberration (SA) IOLs (n = 61). Twenty post-hyperopic femto-LASIK eyes received aberration-free IOLs. Corneal higher-order aberrations (SA, coma, trefoil, and corneal asphericity) for a 6 mm pupil were measured by Scheimpflug tomography. Ray-tracing metrics (visual Strehl optical transfer function [VSOTF], effective range of focus [EROF], sphere shift [SS], EROF-SS), pupil size measurements at far and near, and ocular and corneal SA were obtained using ray-tracing aberrometry. Distance-corrected near visual acuity (DCNVA) and subjective defocus curves up to ±4.0 diopters were evaluated.
RESULTS


Multivariable logistic regression found corneal profile and IOL type to be determinants of extended DOF with monofocal IOLs. The aberration-free IOL group showed significantly better DCNVA and higher total SA than the negative-SA group. Post-hyperopic LASIK eyes showed significantly better DCNVA; higher negative SA, coma, and Q value (P < .05), and smaller pupil size (P = .05) than normal eyes implanted with aberration-free IOLs.
CONCLUSION


Corneal profile and type of IOL implanted were the most important factors influencing near vision functionality with aspheric monofocal IOLs. Higher positive SA in the aberration-free group potentially led to better DCNVA than the negative-SA group in normal eyes. Hyperprolate corneas had better DOF curves and DCNVA than normal corneas. NOTE: Publication of this article is sponsored by the American Ophthalmological Society.",2020,The aberration-free IOL group showed significantly better DCNVA and higher total SA than the negative-SA group.,"['eyes implanted with aspheric monofocal intraocular lenses (IOLs', 'Ninety-one normal eyes', '111 eyes of 74 patients that underwent']","['aberration-free IOLs', 'negative-spherical aberration (SA) (ZCB00) IOLs', 'phacoemulsification with monofocal IOL implantation', 'aberration-free (MX60E']","['DOF curves and DCNVA', 'Corneal higher-order aberrations (SA, coma, trefoil and corneal asphericity for 6-mm pupil', 'DCNVA, higher negative SA, coma and Q value (p<.05), and smaller pupil size', 'Ray tracing metrics [visual strehl optical transfer function (VSOTF), effective range of focus (EROF), sphere shift (SS), EROF-SS], pupil size measurements at far and near, ocular and corneal SA', 'Distance-corrected near visual acuity (DCNVA) and subjective defocus curves']","[{'cui': 'C0581278', 'cui_str': 'Ophthalmological implant'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0950061', 'cui_str': 'Trefoil'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0086894', 'cui_str': 'Rajiformes'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",111.0,0.0231069,The aberration-free IOL group showed significantly better DCNVA and higher total SA than the negative-SA group.,"[{'ForeName': 'Karolinne Maia', 'Initials': 'KM', 'LastName': 'Rocha', 'Affiliation': 'Storm Eye Institute - Medical University of South Carolina, Charleston, South Carolina, USA. Electronic address: rochak@musc.edu.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Gouvea', 'Affiliation': 'Storm Eye Institute - Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'George Oral', 'Initials': 'GO', 'LastName': 'Waring', 'Affiliation': 'Waring Vision Institute, Mt. Pleasant, South Carolina, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Haddad', 'Affiliation': 'Storm Eye Institute - Medical University of South Carolina, Charleston, South Carolina, USA; Federal University of Sao Paulo - UNIFESP, São Paulo, Brazil.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.04.014']
71,32337679,"Sensory and motor responses after photobiomodulation associated with physiotherapy in patients with incomplete spinal cord injury: clinical, randomized trial.","Complete or incomplete spinal cord injury (SCI) results in permanent neurological deficits due to the interruption of nerve impulses, causing the loss of motor and sensory function, which leads to a reduction in quality of life. The focus of rehabilitation for such individuals is to improve quality of life and promote functional recovery. Photobiomodulation (PBM) has proved to be promising complementary treatment in cases of SCI. The aim of the present study was to investigate the effects of PBM combined with physiotherapy on sensory-motor responses below the level of the injury and quality of life in individuals with SCI. Thirty participants were randomized for allocation to the PBM group (active PBM + physiotherapy) or sham group (sham PBM + physiotherapy). Physiotherapy was administered three times a week. Sensitivity and motor skills were evaluated using the ASIA impairment scale. Quality of life was assessed using the WHOQOL-BREF questionnaire. The data were analyzed with the level of significance set to 5%. Improvements in sensitivity and an increase in the perception of muscle contraction were found in the active PBM group 30 days after treatment compared with the sham group. The results of the WHOQOL-BREF questionnaire revealed a significant difference in general quality of life favoring the active PBM group over the sham group after treatment. Physiotherapy combined with PBM leads to better sensory-motor recovery in patients with SCI as well as a better perception of health and quality of life. Trial registration identifier: NCT03031223.",2020,Improvements in sensitivity and an increase in the perception of muscle contraction were found in the active PBM group 30 days after treatment compared with the sham group.,"['patients with SCI', 'Thirty participants', 'individuals with SCI', 'patients with incomplete spinal cord injury']","['PBM combined with physiotherapy', 'PBM group (active PBM + physiotherapy) or sham group (sham PBM + physiotherapy', 'Photobiomodulation (PBM', 'Physiotherapy combined with PBM', 'physiotherapy']","['Sensory and motor responses', 'Quality of life', 'WHOQOL-BREF questionnaire', 'perception of health and quality of life', 'quality of life and promote functional recovery', 'sensory-motor responses', 'ASIA impairment scale', 'perception of muscle contraction', 'general quality of life', 'Sensitivity and motor skills']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",30.0,0.0764164,Improvements in sensitivity and an increase in the perception of muscle contraction were found in the active PBM group 30 days after treatment compared with the sham group.,"[{'ForeName': 'Fernanda Cordeiro', 'Initials': 'FC', 'LastName': 'da Silva', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Tamiris', 'Initials': 'T', 'LastName': 'Silva', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Andréa Oliver', 'Initials': 'AO', 'LastName': 'Gomes', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Paulo Roberto', 'Initials': 'PR', 'LastName': 'da Costa Palácio', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Andreo', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Marcela Leticia Leal', 'Initials': 'MLL', 'LastName': 'Gonçalves', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fátima Teixeira Silva', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Raquel Agnelli', 'Initials': 'RA', 'LastName': 'Mesquita-Ferrari', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Kristianne Porta Santos', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo, SP, Brazil. sandra_skb@gmail.com.'}]",Lasers in medical science,['10.1007/s10103-020-02968-6']
72,32305727,A polymorphism within the R-spondin 2 gene predicts outcome in metastatic colorectal cancer patients treated with FOLFIRI/bevacizumab: data from FIRE-3 and TRIBE trials.,"BACKGROUND


Through enhancement of the Wnt signalling pathway, R-spondins are oncogenic drivers in colorectal cancer. Experimental data suggest that the R-spondin/Wnt axis stimulates vascular endothelial growth factor (VEGF)-dependent angiogenesis. We therefore hypothesise that variations within R-spondin genes predict outcome in patients with metastatic colorectal cancer (mCRC) treated with upfront FOLFIRI and bevacizumab.
PATIENTS AND METHODS


773 patients with mCRC enrolled in the randomised phase III FIRE-3 and TRIBE trials and receiving either FOLFIRI/bevacizumab (training and validation cohorts) or FOLFIRI/cetuximab (control group) were involved in this study. The impact of six functional single-nucleotide polymorphisms (SNPs) within the R-spondin 1-3 genes on outcome was evaluated.
RESULTS


RAS and KRAS wild-type patients harbouring any G allele of the RSPO2 rs555008 SNP had a longer overall survival compared with those having a TT genotype in both the training (FIRE-3) and validation (TRIBE) cohorts (29.0 vs 23.6 months, P = 0.009 and 37.8 vs 19.4 months, P = 0.021 for RAS wild-type patients and 28.4 vs 22.3 months, P = 0.011 and 36.0 vs 23.3 months, P = 0.046 for KRAS wild-type patients). Conversely, any G allele carriers with KRAS and RAS mutant tumours exhibited a shorter progression-free survival compared with TT genotype carriers, whereas the results were clinically more evident for KRAS mutant patients in both the training and validation cohorts (8.1 vs 11.2 months, P = 0.023 and 8.7 vs 10.3 months, P = 0.009).
CONCLUSION


Genotyping of the RSPO2 rs555008 polymorphism may help to select patients who will derive the most benefit from FOLFIRI/bevacizumab dependent on (K)RAS mutational status.",2020,"Conversely, any G allele carriers with KRAS and RAS mutant tumours exhibited a shorter progression-free survival compared with TT genotype carriers, whereas the results were clinically more evident for KRAS mutant patients in both the training and validation cohorts (8.1 vs 11.2 months, P = 0.023 and 8.7 vs 10.3 months, P = 0.009).
","['patients with metastatic colorectal cancer (mCRC) treated with', '773 patients with mCRC enrolled in the randomised phase III FIRE-3 and TRIBE trials and receiving either', 'metastatic colorectal cancer patients treated with']","['FOLFIRI/bevacizumab', 'bevacizumab', 'upfront FOLFIRI and bevacizumab', 'six functional single-nucleotide polymorphisms (SNPs', 'FOLFIRI/bevacizumab (training and validation cohorts) or FOLFIRI/cetuximab (control group']","['overall survival', 'shorter progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0040881', 'cui_str': 'Tribes'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",773.0,0.0944452,"Conversely, any G allele carriers with KRAS and RAS mutant tumours exhibited a shorter progression-free survival compared with TT genotype carriers, whereas the results were clinically more evident for KRAS mutant patients in both the training and validation cohorts (8.1 vs 11.2 months, P = 0.023 and 8.7 vs 10.3 months, P = 0.009).
","[{'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Berger', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Medical Oncology, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address: martin.berger@insel.ch.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Medical Department, Division of Hematology, Oncology, and Tumor Immunology (Campus Charité Mitte), Charité Universitaetsmedizin Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Dongyun', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Mitsukuni', 'Initials': 'M', 'LastName': 'Suenaga', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Schirripa', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Hanna', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Soni', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Puccini', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Ryuma', 'Initials': 'R', 'LastName': 'Tokunaga', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Madiha', 'Initials': 'M', 'LastName': 'Naseem', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Battaglin', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'U.O. Oncologia Medica, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Oncologia Medica 1, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA; Department of Preventive Medicine, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.02.048']
73,31743933,Protocol of a Randomized Controlled Study of the PneumRx Endobronchial Coil System versus Standard-of-Care Medical Management in the Treatment of Subjects with Severe Emphysema (ELEVATE).,"BACKGROUND


The PneumRx endobronchial coil system for patients with severe emphysema has been shown to improve quality of life, exercise capacity, and pulmonary function in patients with emphysema. A post hoc analysis of the RENEW trial has identified patient characteristics and lobar selection methods associated with improved outcomes, which have to be confirmed prospectively.
METHODS


The ELEVATE trial is a prospective, multicenter, open label, randomized (2:1), controlled trial comparing outcomes in patients treated with endobronchial coils (treatment) to a medically managed control group (control). The trial aims to enroll 210 patients (140 in the treatment group and 70 in the control group) with severe emphysema. Control patients will be eligible to crossover to coil treatment after 6 months of follow-up. The co-primary effectiveness endpoints are percent change in forced expiratory volume in 1 s and quality of life measured by change in St. George's Respiratory Questionnaire from baseline to 6 months. Secondary objectives are determination of responder rates of clinical endpoints and mean change in other functional and physiologic endpoints. All patients will be followed for 24 months after initial treatment. Adverse events will be collected on an ongoing basis throughout the trial.
DISCUSSION


The primary objective of the ELEVATE trial is to prospectively confirm the safety and effectiveness profile of the coil system for the treatment of severe emphysema in consideration of the findings of previous randomized controlled trials. Secondary objectives are the determination of responder rates in all clinical endpoints and mean change in physiologic endpoints.",2019,The trial aims to enroll 210 patients (140 in the treatment group and 70 in the control group) with severe emphysema.,"['Subjects with Severe Emphysema (ELEVATE', 'patients treated with endobronchial coils (treatment) to a medically managed control group (control', 'patients with emphysema', 'patients with severe emphysema', 'enroll 210 patients (140 in the treatment group and 70 in the control group) with severe emphysema']","['coil system', 'PneumRx Endobronchial Coil System versus Standard-of-Care Medical Management']","['Adverse events', 'determination of responder rates of clinical endpoints and mean change in other functional and physiologic endpoints', ""forced expiratory volume in 1 s and quality of life measured by change in St. George's Respiratory Questionnaire""]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial (qualifier value)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1148554', 'cui_str': 'determination'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",210.0,0.121048,The trial aims to enroll 210 patients (140 in the treatment group and 70 in the control group) with severe emphysema.,"[{'ForeName': 'Felix J F', 'Initials': 'FJF', 'LastName': 'Herth', 'Affiliation': 'Thoraxklinik and Translational Lung Research Center (TLRC), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'Slebos', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Pallav L', 'Initials': 'PL', 'LastName': 'Shah', 'Affiliation': 'Royal Brompton Hospital and Chelsea and Westminster Hospital, London, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hetzel', 'Affiliation': 'Krankenhaus vom Roten Kreuz, Stuttgart, Germany.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Schmid-Bindert', 'Affiliation': 'PneumRx GmbH, a BTG International Group Company, Mannheim, Germany.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'LaPrad', 'Affiliation': 'PneumRx, Inc., a BTG International Group Company, Santa Clara, California, USA.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Deslée', 'Affiliation': 'University Hospital of Reims, INSERM U1250, Reims, France.'}, {'ForeName': 'Arschang', 'Initials': 'A', 'LastName': 'Valipour', 'Affiliation': 'Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Department of Respiratory and Critical Care Medicine, Krankenhaus Nord-Klinik Floridsdorf, Vienna, Austria, arschang.valipour@wienkav.at.'}]",Respiration; international review of thoracic diseases,['10.1159/000502100']
74,32172171,PSA and VIM DBS efficiency in essential tremor depends on distance to the dentatorubrothalamic tract.,"OBJECTIVE


To investigate the relation between deep brain stimulation (DBS) of the posterior-subthalamic-area (PSA) and the ventral-intermediate-nucleus (VIM) and the distance to the dentatorubrothalamic tract (DRTT) in essential tremor (ET).
METHODS


Tremor rating scale (TRS) hemi-scores were analyzed in 13 ET patients, stimulated in both the VIM and the PSA in a randomized, crossover trial. Distances of PSA and VIM contacts to population-based DRTTs were calculated. The relationships between distance to DRTT and stimulation amplitude, as well as DBS efficiency (TRS improvement per amplitude) were investigated.
RESULTS


PSA contacts were closer to the DRTT (p = 0.019) and led to a greater improvement in TRS hemi-scores (p = 0.005) than VIM contacts. Proximity to the DRTT was related to lower amplitudes (p < 0.001) and higher DBS efficiency (p = 0.017).
CONCLUSIONS


Differences in tremor outcome and stimulation parameters between contacts in the PSA and the VIM can be explained by their different distance to the DRTT.",2020,"RESULTS


PSA contacts were closer to the DRTT (p = 0.019) and led to a greater improvement in TRS hemi-scores (p = 0.005) than VIM contacts.",[],"['deep brain stimulation (DBS) of the posterior-subthalamic-area (PSA) and the ventral-intermediate-nucleus (VIM', 'VIM']","['PSA and VIM DBS efficiency', 'DBS efficiency', 'TRS hemi-scores', 'DBS efficiency (TRS improvement per amplitude', 'Tremor rating scale (TRS) hemi-scores']",[],"[{'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0222045'}]",13.0,0.0220309,"RESULTS


PSA contacts were closer to the DRTT (p = 0.019) and led to a greater improvement in TRS hemi-scores (p = 0.005) than VIM contacts.","[{'ForeName': 'Till A', 'Initials': 'TA', 'LastName': 'Dembek', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany. Electronic address: till.dembek@uk-koeln.de.'}, {'ForeName': 'Jan Niklas', 'Initials': 'JN', 'LastName': 'Petry-Schmelzer', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reker', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wirths', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'University of Cologne, Institute of Medical Statistics and Computational Biology, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Steffen', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Haidar S', 'Initials': 'HS', 'LastName': 'Dafsari', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}, {'ForeName': 'Mauritius', 'Initials': 'M', 'LastName': 'Hövels', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Gereon R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany; Cognitive Neuroscience, Institute of Neuroscience and Medicine (INM-3), Research Center Jülich, Jülich, Germany.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Visser-Vandewalle', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Stereotactic and Functional Neurosurgery, Germany.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Barbe', 'Affiliation': 'University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Neurology, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102235']
75,31473748,Dose Response to Transnasal Pulmonary Administration of Bronchodilator Aerosols via Nasal High-Flow Therapy in Adults with Stable Chronic Obstructive Pulmonary Disease and Asthma.,"BACKGROUND


There has been increasing interest in transnasal pulmonary aerosol administration, but the dose-response relationship has not been reported.
OBJECTIVES


To determine the accumulative bronchodilator dose at which patients with stable mild-to-moderate asthma and chronic obstructive pulmonary disease (COPD) achieve similar spirometry responses before and after bronchodilator tests using albuterol via a metered dose inhaler with a valved holding chamber (MDI + VHC).
METHOD


Adult patients who met ATS/ERS criteria for bronchodilator responses in pulmonary function laboratory were recruited and consented to participate. After a washout period, patients received escalating doubling dosages (0.5, 1, 2, and 4 mg) of albuterol in a total volume of 2 mL delivered by vibrating mesh nebulizer via a nasal cannula at 37°C with a flow rate of 15-20 L/min using a Venturi air entrainment device. Spirometry was measured at baseline and after each dose. Titration was stopped when an additional forced expiratory volume in 1 second (FEV1) improvement was <5%.
RESULTS


42 patients (16 males) with stable mild-to-moderate asthma (n = 29) and COPD (n = 13) were enrolled. FEV1 increment after a cumulative dose of 1.5 mg of albuterol via nasal cannula at 15-20 L/min was similar to 4 actuations of MDI + VHC (0.34 ± 0.18 vs. 0.34 ± 0.12 L, p = 0.878). Using ATS/ERS criteria of the bronchodilator test, 33.3% (14/42) and 69% (29/42) of patients responded to 0.5 and 1.5 mg of albuterol, respectively.
CONCLUSIONS


With a nasal cannula at 15-20 L/min, transnasal pulmonary delivery of 1.5 mg albuterol resulted in similar bronchodilator response as 4 actuations of MDI + VHC.",2019,"FEV1 increment after a cumulative dose of 1.5 mg of albuterol via nasal cannula at 15-20 L/min was similar to 4 actuations of MDI + VHC (0.34 ± 0.18 vs. 0.34 ± 0.12 L, p = 0.878).","['Adults with Stable Chronic Obstructive Pulmonary Disease and Asthma', '42 patients (16 males) with stable mild-to-moderate asthma (n = 29) and COPD (n = 13) were enrolled', 'patients with stable mild-to-moderate asthma and chronic obstructive pulmonary disease (COPD', 'Adult patients who met ATS/ERS criteria for bronchodilator responses in pulmonary function laboratory were recruited and consented to participate']","['Bronchodilator Aerosols via Nasal High-Flow Therapy', 'albuterol', 'albuterol via a metered dose inhaler with a valved holding chamber (MDI + VHC']",['FEV1'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C1553387', 'cui_str': 'Hold'}]",[],42.0,0.189401,"FEV1 increment after a cumulative dose of 1.5 mg of albuterol via nasal cannula at 15-20 L/min was similar to 4 actuations of MDI + VHC (0.34 ± 0.18 vs. 0.34 ± 0.12 L, p = 0.878).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Division of Respiratory Care, Department of Cardiopulmonary Sciences, Rush University Medical Center, Chicago, Illinois, USA, Jie_Li@rush.edu.'}, {'ForeName': 'Minghua', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': ""Division of Pulmonary Function Test Laboratory, Department of Respiratory Care, People's Hospital of the Xinjiang Autonomous Region, Urumqi, China.""}, {'ForeName': 'Maierbati', 'Initials': 'M', 'LastName': 'Hadeer', 'Affiliation': ""Division of Pulmonary Function Test Laboratory, Department of Respiratory Care, People's Hospital of the Xinjiang Autonomous Region, Urumqi, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, West China School of Medicine and West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Fink', 'Affiliation': 'Division of Respiratory Care, Department of Cardiopulmonary Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}]",Respiration; international review of thoracic diseases,['10.1159/000501564']
76,31485039,Posterior capsule opacification and Nd:YAG laser rates with two hydrophobic acrylic single-piece IOLs.,"OBJECTIVES


To evaluate the development of posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates following implantation of two hydrophobic acrylic IOLs.
METHODS


In a randomized, controlled trial, 80 patients with bilateral senile cataract were implanted with the hydrophobic acrylic single-piece intraocular Lenses (IOLs) EyeCee One in one eye and iMics1 in the other. Outcomes of 39 patients (78 eyes) were evaluated after 3 years. Automated Quantification of After-Cataract (AQUA; for PCO occurrence), visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface were analysed.
RESULTS


After a mean follow-up of 38 ± 1.95 months, Nd:YAG capsulotomy occurred at a rate of 15.4% and 46.2% in the EyeCee One and iMics1 groups, respectively (p < 0.01). Respective mean PCO scores measured by AQUA were 1.57 ± 1.63 and 2.45 ± 1.44 (p = 0.019). A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes. A gap between the posterior capsule and the posterior surface of the lens was observed in 76% of EyeCee One eyes and 35% of iMics1 eyes.
CONCLUSIONS


Study findings suggest that PCO and Nd:YAG capsulotomy rates are significantly lower in eyes implanted with the EyeCee One IOL compared to the iMics1 IOL. Optic sharpness and lens material seem to be the decisive factors, while the stepped edge beneath the haptic junction appeared to be ineffective.",2020,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"['80 patients with bilateral senile cataract', '39 patients (78 eyes) were evaluated after 3 years']","['hydrophobic acrylic single-piece intraocular Lenses (IOLs', 'hydrophobic acrylic single-piece IOLs', 'posterior capsule opacification (PCO) and Nd']","['PCO and Nd:YAG capsulotomy rates', 'Respective mean PCO scores', 'visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface', 'IOL optic', 'YAG capsulotomy rates', 'YAG capsulotomy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2025430', 'cui_str': 'Senile cataract of both eyes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",80.0,0.0689483,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Pieh', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. rupert.menapace@meduniwien.ac.at.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriechbaum', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]","Eye (London, England)",['10.1038/s41433-019-0569-x']
77,32300129,Mindfulness Meditation Activates Altruism.,"Clinical evidence suggests that mindfulness meditation reduces anxiety, depression, and stress, and improves emotion regulation due to modulation of activity in neural substrates linked to the regulation of emotions and social preferences. However, less was known about whether mindfulness meditation might alter pro-social behavior. Here we examined whether mindfulness meditation activates human altruism, a component of social cooperation. Using a simple donation game, which is a real-world version of the Dictator's Game, we randomly assigned 326 subjects to a mindfulness meditation online session or control and measured their willingness to donate a portion of their payment for participation as a charitable donation. Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics. We also found a larger treatment effect of meditation among those who did not go to college (p < 0.001) and those who were under 25 years of age (p < 0.001), with both subject groups contributing virtually nothing in the control condition. Our results imply high context modularity of human altruism and the development of intervention approaches including mindfulness meditation to increase social cooperation, especially among subjects with low baseline willingness to contribute.",2020,"Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics.",['326 subjects to a'],"['mindfulness meditation online session or control and measured their willingness to donate a portion of their payment for participation as a charitable donation', 'mindfulness meditation']","['anxiety, depression, and stress, and improves emotion regulation']","[{'cui': 'C5191353', 'cui_str': '326'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",326.0,0.0125002,"Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics.","[{'ForeName': 'Sage K', 'Initials': 'SK', 'LastName': 'Iwamoto', 'Affiliation': 'College of Letters & Sciences, UC Berkeley, Berkeley, CA, 94720, United States.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Mindful Awareness Research Center and Cousins Center for Psychoneuroimmunology, Jane and Terry Semel Institute for Neuroscience at UCLA, and Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, CA, 90095, United States.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Christakis', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nishi', 'Affiliation': 'Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA, 90095, United States. akihironishi@ucla.edu.'}]",Scientific reports,['10.1038/s41598-020-62652-1']
78,31784483,Genetic variability and potential effects on clinical trial outcomes: perspectives in Parkinson's disease.,"BACKGROUND


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


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


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


Our data support the hypothesis that within genetically unmatched clinical trials, genetic heterogeneity could confound true therapeutic effects as expected. Clinical trials should undergo pretrial genetic adjustment or, at the minimum, post-trial adjustment and analysis for failed trials.",2020,"Glucocerebrocidase (GBA) gene-only simulations see an average 18.86%, 95% CI 18.01 to 19.71 difference in GRS scores between trial arms (n=50).","[""5851 patients with Parkinson's disease of European ancestry data and two simulated virtual cohorts based on public data were used"", ""5851 patients with Parkinson's disease (mean (SD) age, 61.02"", '12.61) years; 2095 women (35.81%)) as well as simulated patients from virtually created cohorts were used in the study', ""Parkinson's disease""]",[],"['false negatives', 'genetic risk score (GRS) and allele frequency', 'individual risk SNPs', 'GRS scores', 'False-negative and false-positive rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0205558', 'cui_str': 'False negative (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017270', 'cui_str': 'Allele Frequency'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0205557', 'cui_str': 'False positive (qualifier value)'}]",2095.0,0.444393,"Glucocerebrocidase (GBA) gene-only simulations see an average 18.86%, 95% CI 18.01 to 19.71 difference in GRS scores between trial arms (n=50).","[{'ForeName': 'Hampton', 'Initials': 'H', 'LastName': 'Leonard', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Blauwendraat', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Krohn', 'Affiliation': 'Department of Human Genetics, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Faraz', 'Initials': 'F', 'LastName': 'Faghri', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iwaki', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Ferguson', 'Affiliation': 'Caserta Concepts LLC, New York City, New York, USA.'}, {'ForeName': 'Aaron G', 'Initials': 'AG', 'LastName': 'Day-Williams', 'Affiliation': 'Merck and Co, Boston, Massachusetts, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stone', 'Affiliation': 'Merck and Co, Boston, Massachusetts, USA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Singleton', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Mike A', 'Initials': 'MA', 'LastName': 'Nalls', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Bethesda, Maryland, USA ziv.gan-or@mcgill.ca mike@datatecnica.com.'}, {'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Gan-Or', 'Affiliation': 'Department of Human Genetics, McGill University, Montreal, Québec, Canada ziv.gan-or@mcgill.ca mike@datatecnica.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of medical genetics,['10.1136/jmedgenet-2019-106283']
79,32323192,Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation.,"Rivaroxaban exposure and patient characteristics may affect the rivaroxaban benefit-risk balance. This study aimed to quantify associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in patients with non-valvular atrial fibrillation (NVAF), using data from the phase 3 ROCKET AF trial (NCT00403767). In ROCKET AF, 14,264 patients with NVAF were randomized to rivaroxaban (20 mg once daily [OD], or 15 mg OD if creatinine clearance was 30-49 mL/min) or dose-adjusted warfarin (median follow-up: 707 days); rivaroxaban plasma concentration was measured in a subset of 161 patients. In this post hoc exposure-response analysis, a multivariate Cox model was used to correlate individual predicted rivaroxaban exposures and patient characteristics with time-to-event efficacy and safety outcomes in 7061 and 7111 patients, respectively. There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes. Creatinine clearance and history of stroke were significantly associated with efficacy outcomes. C trough  was significantly associated with the composite of major or non-major clinically relevant (NMCR) bleeding (hazard ratio [95th percentile vs. median]: 1.26 [95% confidence interval 1.13-1.40]) but not with major bleeding alone. The exposure-response relationship for major or NMCR bleeding was shallow with no clear threshold for an acceleration in risk. History of gastrointestinal bleeding had a greater influence on safety outcomes than C trough . These results support fixed rivaroxaban 15 mg and 20 mg OD dosages in NVAF. Therapeutic drug monitoring is unlikely to offer clinical benefits in this indication beyond evaluation of patient characteristics.",2020,There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes.,"['14,264 patients with NVAF', 'patients with non-valvular atrial fibrillation (NVAF', 'patients with non-valvular atrial fibrillation']","['rivaroxaban', 'Rivaroxaban']","['safety outcomes', 'rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes', 'composite of major or non-major clinically relevant (NMCR) bleeding', 'Creatinine clearance and history of stroke', 'rivaroxaban plasma concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",14264.0,0.0632288,There was no significant association between model-predicted rivaroxaban trough plasma concentration (C trough ) and efficacy outcomes.,"[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA. LZhang11@ITS.JNJ.com.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Nandy', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hermanowski-Vosatka', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'Thrombosis & Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.'}, {'ForeName': 'Manesh', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Peters', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02077-9']
80,32078929,The experiences of therapists providing cognitive behavioral therapy (CBT) for dissociative seizures in the CODES randomized controlled trial: A qualitative study.,"OBJECTIVES


Little is known about the experiences of therapists delivering psychotherapy for patients with dissociative seizures (DS), a complex disorder associated with a range of comorbid psychosocial and mental health difficulties. This study set out to explore therapists' experiences of delivering DS-specific, manualized cognitive behavioral therapy (CBT) to adults with DS within the context of a randomized control trial.
METHODS


Interviews were conducted with 12 therapists involved in the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial and were analyzed using thematic framework analysis (TFA).
RESULTS


Six main themes emerged, namely 1) aspects of the intervention that were favored, while others were not always considered applicable; 2) multiple and complex difficulties faced by patients; 3) working effectively within the protocol; 4) limitations of the protocol; 5) significance of formulation; and 6) quality of standardized medical care (SMC) and difficulties of diagnosis delivery. These addressed valued aspects of the intervention, complexities of the patient group, and experiences working within a structured treatment protocol. Family involvement and psychoeducation were highlighted as important components; the applicability of graded exposure techniques, however, was restricted by patients' apparent emotional avoidance. The structure provided by the treatment protocol was valued, but flexibility was important to individualize treatment in complex cases. A comprehensive formulation was fundamental to this. The initial diagnostic explanation provided by neurologists and psychiatrists was generally considered beneficial, with patients often perceived to enter therapy with a better understanding of their condition.
CONCLUSIONS


This study demonstrated that the DS-specific CBT intervention met with general approval from therapists who also highlighted some practical challenges. Because of the nature of the condition, the need for experience of working with complex patients should be considered when applying the intervention to individual cases. Setting the CBT intervention in the context of a structured care pathway involving neurology and psychiatry may facilitate the therapeutic process.",2020,"METHODS


Interviews were conducted with 12 therapists involved in the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial and were analyzed using thematic framework analysis (TFA).
","['for adults with Dissociative non-Epileptic Seizures (CODES) trial and were analyzed using thematic framework analysis (TFA', 'patients with dissociative seizures (DS', 'Interviews were conducted with 12 therapists involved in the', 'adults with DS within the context of a randomized control trial']","['therapists providing cognitive behavioral therapy (CBT', 'DS-specific, manualized cognitive behavioral therapy (CBT', 'CBT intervention', 'COgnitive behavioral therapy vs standardized medical care', 'DS-specific CBT intervention']",['6) quality of standardized medical care (SMC) and difficulties of diagnosis delivery'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3495874', 'cui_str': 'Nonepileptic Seizures'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0349245', 'cui_str': 'Sham seizures'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",,0.0380774,"METHODS


Interviews were conducted with 12 therapists involved in the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial and were analyzed using thematic framework analysis (TFA).
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wilkinson', 'Affiliation': 'Canterbury Christ Church University, Salomons Institute for Applied Psychology, Tunbridge Wells, UK; South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Elana', 'Initials': 'E', 'LastName': 'Day', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Purnell', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Izabela', 'Initials': 'I', 'LastName': 'Pilecka', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Perdue', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Edyta Monika', 'Initials': 'EM', 'LastName': 'Hunter', 'Affiliation': 'Canterbury Christ Church University, Salomons Institute for Applied Psychology, Tunbridge Wells, UK.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. Electronic address: laura.goldstein@kcl.ac.uk.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.106943']
81,32319673,"Neuronavigation-Guided rTMS for the Treatment of Depressive Patients With Suicidal Ideation: A Double-Blind, Randomized, Sham-Controlled Trial.","During the last decade, the problem of suicide has become more serious in individuals with depression. Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder (MDD). This study aims to investigate the efficacy of magnetic resonance imaging (MRI)-based neuronavigation-guided daily high-dose rTMS for rapidly improving suicidal ideation in treatment-naive patients with MDD. In the present 1-week double-blind study, 42 treatment-naive patients with MDD with suicidal ideation were randomly assigned to the treatment of escitalopram oxalate tablets (10 mg/d) in combination with either active (n = 21) or sham (n = 21) rTMS. The TMS coil was positioned over a specified target location (-44, 40, and 29) in left dorsolateral prefrontal cortex based on MRI data. The severity of suicidal ideation was measured by the Beck Scale for Suicide Ideation (BSI). The 24-item Hamilton Depression Rating Scale (HAMD-24) and Montgomery-Åsberg Depression Rating Scale (MADRS) were utilized to assess the severity of depression. The Wisconsin Card Sorting Test, Continuous Performance Test, and Stroop Color-Word Test were adopted to assess executive function. In contrast to the sham group, the active rTMS group showed a significantly greater BSI score reduction at the third day and the seventh day (P < 0.001). Moreover, the active rTMS group showed a significantly greater HAMD (P < 0.001) and MADRS (P < 0.001) score reduction at the seventh day in comparison to the sham group. The present findings suggested that the neuronavigation-guided high-dose rTMS may be a novel method to rapidly reduce suicidal ideation and mitigate depressive symptoms.",2020,"Moreover, the active rTMS group showed a significantly greater HAMD (p < 0.001) and MADRS (p < 0.001) score reduction at the seventh day in comparison with the sham group.","['major depressive disorder (MDD', '42 treatment-naive MDD patients with suicidal ideation', 'individuals with depression', 'depressive patients with suicidal ideation', 'treatment-naive MDD patients']","['Repetitive transcranial magnetic stimulation (rTMS', 'MRI-based neuronavigation-guided daily high-dose rTMS', 'escitalopram oxalate tablets (10 mg/d) in combination with either active (n = 21) or sham (n = 21) rTMS', 'Neuronavigation-guided rTMS']","['HAMD', 'suicidal ideation', 'severity of suicidal ideation', 'Wisconsin Card Sorting Test (WCST), Continuous Performance Test (CPT) and Stroop Color-Word Test (SCWT', '24-item Hamilton Depression Rating Scale (HAMD-24) and Montgomery-Asberg Depression Rating Scale (MADRS', 'Beck Scale for Suicide Ideation', 'BSI score reduction', 'MADRS', 'suicidal ideation and mitigate depressive symptom']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136207', 'cui_str': 'Frameless Stereotaxy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1170746', 'cui_str': 'Escitalopram oxalate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582675', 'cui_str': 'Stroop neuropsychological screening test'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582614', 'cui_str': 'Beck scale for suicide ideation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",42.0,0.0772028,"Moreover, the active rTMS group showed a significantly greater HAMD (p < 0.001) and MADRS (p < 0.001) score reduction at the seventh day in comparison with the sham group.","[{'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Pan', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'JianPing', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jinkai', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shangda', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wei', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Desheng', 'Initials': 'D', 'LastName': 'Shang', 'Affiliation': ""Department of Radiology, First Affiliated Hospital, College of Medicine, The Key Laboratory of Mental Disorder's Management of Zhejiang Province, Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Manli', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1858']
82,32370640,Propensity score-integrated composite likelihood approach for augmenting the control arm of a randomized controlled trial by incorporating real-world data.,"In this paper, a propensity score-integrated composite likelihood (PSCL) approach is developed for cases in which the control arm of a two-arm randomized controlled trial (RCT) (treated vs control) is augmented with patients from real-world data (RWD) containing both clinical outcomes and covariates at the patient-level. RWD patients who were treated with the same therapy as the control arm of the RCT are considered for the augmentation. The PSCL approach first estimates the propensity score for every patient as the probability of the patient being in the RCT rather than the RWD, and then stratifies all patients into strata based on the estimated propensity scores. Within each propensity score stratum, a composite likelihood function is specified and utilized to down-weight the information contributed by the RWD source. Estimates of the stratum-specific parameters are obtained by maximizing the composite likelihood function. These stratum-specific estimates are then combined to obtain an overall population-level estimate of the parameter of interest. The performance of the proposed approach is evaluated via a simulation study. A hypothetical two-arm RCT and a hypothetical RWD source are used to illustrate the implementation of the proposed approach.",2020,"In this paper, a propensity score-integrated composite likelihood (PSCL) approach is developed for cases in which the control arm of a two-arm randomized controlled trial (RCT) (treated vs control) is augmented with patients from real-world data (RWD) containing both clinical outcomes and covariates at the patient-level.",[],[],[],[],[],[],,0.0425411,"In this paper, a propensity score-integrated composite likelihood (PSCL) approach is developed for cases in which the control arm of a two-arm randomized controlled trial (RCT) (treated vs control) is augmented with patients from real-world data (RWD) containing both clinical outcomes and covariates at the patient-level.","[{'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Chenguang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Tiwari', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Yunling', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}, {'ForeName': 'Lilly Q', 'Initials': 'LQ', 'LastName': 'Yue', 'Affiliation': 'Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2020.1730877']
83,32379640,Mindfulness-based skills training group for parents of obsessive-compulsive disorder-affected children: A caregiver-focused intervention.,"BACKGROUND AND PURPOSE


Parents of children with obsessive-compulsive disorder (OCD) report significant emotional and socio-occupational impacts. There is, however, currently insufficient support for these parents. This study examined a mindfulness-based intervention for parents of OCD-affected children, investigating its feasibility and impact on parental ability to tolerate their child's OCD-related distress, in addition to exploring potential indirect effects.
MATERIALS AND METHODS


Parents of OCD-affected children (n = 39) completed an eight-week baseline observation period followed by eight, weekly manualized mindfulness-based intervention group sessions. Measures of parental tolerance of child distress, dispositional mindfulness, family accommodation, family functioning, and OCD symptom severity were collected.
RESULTS


In comparison to the baseline observation period, parental tolerance of child distress and dispositional mindfulness significantly improved following mindfulness training. No other temporal differences were observed. Parents reported high satisfaction.
CONCLUSION


Mindfulness-based skills training for parents of OCD-affected youth appears to be feasible and to significantly increase tolerance related to the child's distress.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03212703.",2020,"In comparison to the baseline observation period, parental tolerance of child distress and dispositional mindfulness significantly improved following mindfulness training.","['parents of OCD-affected children', 'Parents of OCD-affected children (n\xa0', 'Parents of children with obsessive-compulsive disorder (OCD', 'parents of obsessive-compulsive disorder-affected children']","['Mindfulness-based skills training', 'manualized mindfulness-based intervention group sessions']","['parental tolerance of child distress, dispositional mindfulness, family accommodation, family functioning, and OCD symptom severity', 'parental tolerance of child distress and dispositional mindfulness']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",39.0,0.0208641,"In comparison to the baseline observation period, parental tolerance of child distress and dispositional mindfulness significantly improved following mindfulness training.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Belschner', 'Affiliation': ""Psychiatry, Faculty of Medicine, University of British Columbia, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada; British Columbia Children's Hospital Research Institute, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada. Electronic address: lbelschn@sfu.ca.""}, {'ForeName': 'Sarah Yao', 'Initials': 'SY', 'LastName': 'Lin', 'Affiliation': ""Psychiatry, Faculty of Medicine, University of British Columbia, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada; British Columbia Children's Hospital Research Institute, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada. Electronic address: slin@bcchr.ca.""}, {'ForeName': 'Diana Franco', 'Initials': 'DF', 'LastName': 'Yamin', 'Affiliation': ""Psychiatry, Faculty of Medicine, University of British Columbia, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada; British Columbia Children's Hospital Research Institute, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada. Electronic address: dfrancoy@bcchr.ca.""}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Best', 'Affiliation': ""Psychiatry, Faculty of Medicine, University of British Columbia, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada; British Columbia Children's Hospital Research Institute, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada. Electronic address: john.best@bcchr.ca.""}, {'ForeName': 'Kourosh', 'Initials': 'K', 'LastName': 'Edalati', 'Affiliation': ""Psychiatry, Faculty of Medicine, University of British Columbia, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada; British Columbia Children's Hospital Research Institute, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada. Electronic address: Edalati.Kourosh@cw.bc.ca.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'McDermid', 'Affiliation': ""Psychiatry, Faculty of Medicine, University of British Columbia, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada; BC Children's Hospital Centre for Mindfulness, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada. Electronic address: Joanna.McDermid@cw.bc.ca.""}, {'ForeName': 'S Evelyn', 'Initials': 'SE', 'LastName': 'Stewart', 'Affiliation': ""Psychiatry, Faculty of Medicine, University of British Columbia, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada; British Columbia Children's Hospital Research Institute, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada; BC Children's Hospital Centre for Mindfulness, A3-121, 938 West 28th Avenue, Vancouver, BC, V5Z 4H4, Canada. Electronic address: evelyn.stewart@ubc.ca.""}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101098']
84,32337491,A Randomized Controlled Trial of Emotion Regulation Therapy for Psychologically Distressed Caregivers of Cancer Patients.,"Background


Previous cognitive behavioral therapies for informal caregivers (ICs) have produced negligible effects. The purpose of this study was to evaluate, in a randomized controlled trial, the efficacy of Emotion Regulation Therapy adapted for caregivers (ERT-C) on psychological and inflammatory outcomes in psychologically distressed ICs and the cancer patients cared for.
Methods


A total of 81 ICs with elevated psychological distress were randomly assigned to ERT-C or a waitlist condition and assessed pre-, mid-, and post-treatment. In 52 cases, the patient cared for by the IC was included. Patients did not receive ERT-C. Both the ERT-C and waitlist groups were followed 3 and 6 months post-treatment. Data were analyzed with multilevel models, and  P  values were two-sided.
Results


Compared with ICs in the waitlist condition, ICs in the ERT-C condition experienced medium to large statistically significant reductions in psychological distress (Hedge's  g  =   0.86, 95% confidence interval [CI] = 0.40 to 1.32,  P <  .001), worry ( g  =   0.96, 95% CI = 0.50 to 1.42,  P <  .001), and caregiver burden ( g  =   0.53, 95% CI = 0.10 to 1.99,  P  = .007) post-treatment. No statistically significant effects were found for rumination ( g  =   0.24, 95% CI = -0.20 to 0.68,  P  = .220). Results concerning caregiver burden were maintained through 6 months follow-up. Although the effects on psychological distress and worry diminished, their end-point effects remained medium to large. No statistically significant effects on systemic inflammation were detected (C-reactive protein:  g  = .17, 95% CI = -0.27 to 0.61,  P  = .570; interleukin-6:  g  = .35, 95% CI = -0.09 to 0.79,  P  = .205; tumor necrosis factor-alpha:  g  = .11, 95% CI = -0.33 to 0.55,  P  = .686). Patients whose ICs attended ERT-C experienced a large increase in quality of life post-treatment ( g  =   0.88, 95% CI = 0.18 to 1.58,  P  = .017).
Conclusions


To our knowledge, this is the first randomized controlled trial evaluating the efficacy of ERT-C for ICs. Given the previous disappointing effects of other cognitive behavioral therapies for this population, the present findings are very encouraging. Identifying ICs with elevated psychological distress and providing them with relevant psychotherapy appears an important element of comprehensive cancer care.",2020,"No statistically significant effects on systemic inflammation were detected (C-reactive protein:  g  = .17, 95% CI","['A total of 81 ICs with elevated psychological distress', 'informal caregivers (ICs', 'psychologically distressed ICs and the cancer patients cared for', 'Psychologically Distressed Caregivers of Cancer Patients']","['Emotion Regulation Therapy', 'ERT-C', 'ERT-C or a waitlist condition and assessed pre-, mid-, and post-treatment', 'Emotion Regulation Therapy adapted for caregivers (ERT-C']","['rumination', 'caregiver burden', 'systemic inflammation', 'quality of life post-treatment', 'psychological distress']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",81.0,0.194614,"No statistically significant effects on systemic inflammation were detected (C-reactive protein:  g  = .17, 95% CI","[{'ForeName': 'Mia S', 'Initials': 'MS', 'LastName': ""O'Toole"", 'Affiliation': 'Unit for Psychooncology and Health Psychology, Aarhus University and Aarhus University Hospital, Denmark.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Mennin', 'Affiliation': 'Department of Psychology, Teachers College, Columbia University, New York, NY.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Applebaum', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Rose', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fresco', 'Affiliation': 'Department of Psychological Sciences, Kent State University, Kent, OH.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zachariae', 'Affiliation': 'Unit for Psychooncology and Health Psychology, Aarhus University and Aarhus University Hospital, Denmark.'}]",JNCI cancer spectrum,['10.1093/jncics/pkz074']
85,31220851,Safety and Dose Study of Targeted Lung Denervation in Moderate/Severe COPD Patients.,"RATIONALE


Targeted lung denervation (TLD) is a novel bronchoscopic treatment for the disruption of parasympathetic innervation of the lungs.
OBJECTIVES


To assess safety, feasibility, and dosing of TLD in patients with moderate to severe COPD using a novel device design.
METHODS


Thirty patients with COPD (forced expiratory volume in 1 s 30-60%) were 1:1 randomized in a double-blinded fashion to receive TLD with either 29 or 32 W. Primary endpoint was the rate of TLD-associated adverse airway effects that required treatment through 3 months. Assessments of lung function, quality of life, dyspnea, and exercise capacity were performed at baseline and 1-year follow-up. An additional 16 patients were enrolled in an open-label confirmation phase study to confirm safety improvements after procedural enhancements following gastrointestinal adverse events during the randomized part of the trial.
RESULTS


Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group, p = 0.6. Five patients early in the randomized phase experienced serious gastric events. The study was stopped and procedural changes made that reduced both gastrointestinal and airway events in the subsequent phase of the randomized trial and follow-up confirmation study. Improvements in lung function and quality of life were observed compared to baseline values for both doses but were not statistically different.
CONCLUSIONS


The results demonstrate acceptable safety and feasibility of TLD in patients with COPD, with improvements in adverse event rates after procedural enhancements.",2019,"Improvements in lung function and quality of life were observed compared to baseline values for both doses but were not statistically different.
","['Thirty patients with COPD (forced expiratory volume in 1 s 30-60', 'patients with COPD', 'Moderate/Severe COPD Patients', 'patients with moderate to severe COPD using a novel device design', '16 patients']",['TLD'],"['device success without an in-hospital serious adverse event', 'rate of TLD-associated adverse airway effects requiring intervention', 'gastrointestinal and airway events', 'serious gastric events', 'rate of TLD-associated adverse airway effects', 'lung function and quality of life', 'adverse event rates', 'lung function, quality of life, dyspnea, and exercise capacity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0086137', 'cui_str': 'Device Design'}]",[],"[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1320715', 'cui_str': 'Airway event'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0034380'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",30.0,0.0961483,"Improvements in lung function and quality of life were observed compared to baseline values for both doses but were not statistically different.
","[{'ForeName': 'Arschang', 'Initials': 'A', 'LastName': 'Valipour', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto-Wagner-Spital, Vienna, Austria.'}, {'ForeName': 'Pallav L', 'Initials': 'PL', 'LastName': 'Shah', 'Affiliation': 'Royal Brompton and Harefield NHS Trust, Chelsea and Westminster Hospital, and Imperial College, London, United Kingdom.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pison', 'Affiliation': 'Service Hospitalier Universitaire Pneumologie Physiologie, Centre Hospitalier Universitaire Grenoble Alpes, InsermU1055, Université Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Ninane', 'Affiliation': 'CHU Saint-Pierre, Université libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Janssens', 'Affiliation': 'Department of Respiratory Diseases, KU Leuven, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Perez', 'Affiliation': 'CHU Lille, Center for Infection and Immunity of Lille, INSERM U1019, CNRS UMR 8204 Univ Lille Nord de France, Lille, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Kessler', 'Affiliation': 'Service de Pneumologie, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Gaetan', 'Initials': 'G', 'LastName': 'Deslee', 'Affiliation': 'CHU de Reims, Hôpital Maison Blanche, INSERM UMRS 1250, Service de Pneumologie, Reims, France.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Garner', 'Affiliation': 'Royal Brompton and Harefield NHS Trust, Chelsea and Westminster Hospital, and Imperial College, London, United Kingdom.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Abele', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto-Wagner-Spital, Vienna, Austria.'}, {'ForeName': 'Jorine E', 'Initials': 'JE', 'LastName': 'Hartman', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'Slebos', 'Affiliation': 'Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands, d.j.slebos@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiration; international review of thoracic diseases,['10.1159/000500463']
86,31923778,Effect of different exercise programs on non-specific chronic low back pain and disability in people who perform sedentary work.,"BACKGROUND


This study compared the short- and long-term effects of different exercise programs on lumbar muscle function, cross-sectional area of the multifidus muscle, functional disability and low back pain in people who perform sedentary work.
METHODS


A total of 70 volunteer women with sedentary occupations suffering from low back pain were randomized to either the lumbar stabilization exercise program group or the lumbar muscle strengthening exercise program group. All subjects entered the 20-week exercise programs. The measurement of the cross-sectional area of the multifidus muscle was executed by using an ultrasound system, isokinetic peak torque was measured applying an isokinetic dynamometer.
FINDINGS


The results indicated that the 20-week exercise programs reduced low back pain and functional disability. Positive effects for the cross-sectional area of the multifidus muscle, functional disability and low back pain lasted for 4 weeks after the application of lumbar muscle strengthening exercise program and for 12 weeks after the application of lumbar stabilization exercise program. The lumbar muscle strength increased and lasted for 8 weeks after both exercise programs.
INTERPRETATION


The 20-week lumbar stabilization exercise and muscle strengthening exercise programs were efficacious in decreasing LBP and functional disability in people performing sedentary work, however the lumbar stabilization exercise program was more effective, and this effect lasted for 12 weeks after completion of the program.",2020,"Positive effects for the cross-sectional area of the multifidus muscle, functional disability and low back pain lasted for 4 weeks after the application of lumbar muscle strengthening exercise program and for 12 weeks after the application of lumbar stabilization exercise program.","['70 volunteer women with sedentary occupations suffering from low back pain', 'people who perform sedentary work']","['lumbar muscle strengthening exercise program', 'exercise programs', 'lumbar stabilization exercise program group or the lumbar muscle strengthening exercise program group', 'lumbar stabilization exercise and muscle strengthening exercise programs', 'lumbar stabilization exercise program']","['lumbar muscle function, cross-sectional area of the multifidus muscle, functional disability and low back pain', 'lumbar muscle strength', 'low back pain and functional disability', 'LBP and functional disability']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043227', 'cui_str': 'Work'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0224319', 'cui_str': 'Multifidus'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",70.0,0.0360491,"Positive effects for the cross-sectional area of the multifidus muscle, functional disability and low back pain lasted for 4 weeks after the application of lumbar muscle strengthening exercise program and for 12 weeks after the application of lumbar stabilization exercise program.","[{'ForeName': 'Saule', 'Initials': 'S', 'LastName': 'Sipaviciene', 'Affiliation': 'Department of Applied Biology and Rehabilitation, Lithuanian Sports University, Lithuania. Electronic address: saule.sipaviciene@lsu.lt.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Kliziene', 'Affiliation': 'Department of Education Science, Kaunas University of Technology, Lithuania.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2019.12.028']
87,31954228,Impact of Tai Chi Yuttari-exercise on arteriosclerosis and physical function in older people.,"OBJECTIVES


This non-randomized controlled study investigated the impact of practicing Tai Chi Yuttari-exercise for 1 year on arteriosclerosis status and physical functioning of community-dwelling older people.
METHODS


Vascular and physical function were compared between 45 and 44 individuals who had and had not participated in Tai Chi Yuttari classes for 1 year, respectively. Participants deemed unsuitable for exercise by a physician, unable to walk unaided, with severely limited activities of daily living, with serious circulatory or respiratory disease, undergoing treatment for an acute or chronic motor organ disease, with seriously impaired motor function of the upper or lower limbs, with a history of myocardial infarction or cerebral stroke within the previous 6 months, and with previous serious infection were excluded.
RESULTS


The mean cardio-ankle vascular index improved significantly from 8.44 at baseline to 8.20 after 6 months in the intervention group; however, no significant difference was observed at 1 year. Conversely, compared with baseline, the functional reach, gait speed, and timed up-and-go test results improved significantly after 6 months in this group; these improvements were maintained after 1 year. No significant changes in arteriosclerosis or physical function were observed in the control group.
CONCLUSIONS


The practice of Tai Chi Yuttari-exercise is effective in maintaining and improving arteriosclerosis status and physical function in older people. However, it may be performed at least thrice a week for maintaining or improving arteriosclerosis status.",2020,"Conversely, compared with baseline, the functional reach, gait speed, and timed up-and-go test results improved significantly after 6 months in this group; these improvements were maintained after 1 year.","['Participants deemed unsuitable for exercise by a physician, unable to walk unaided, with severely limited activities of daily living, with serious circulatory or respiratory disease, undergoing treatment for an acute or chronic motor organ disease, with seriously impaired motor function of the upper or lower limbs, with a history of myocardial infarction or cerebral stroke within the previous 6 months, and with previous serious infection were excluded', 'older people', 'community-dwelling older people', 'Vascular and physical function were compared between 45 and 44 individuals who had and had not participated in Tai Chi Yuttari classes for 1\u2009year, respectively']","['Tai Chi Yuttari-exercise', 'practicing Tai Chi Yuttari-exercise']","['arteriosclerosis status', 'arteriosclerosis status and physical functioning', 'arteriosclerosis or physical function', 'arteriosclerosis status and physical function', 'functional reach, gait speed, and timed up-and-go test results', 'arteriosclerosis and physical function', 'mean cardio-ankle vascular index']","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0560046', 'cui_str': 'Unable to walk (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0035204', 'cui_str': 'Respiration Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1275835', 'cui_str': 'Past history of myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0003850', 'cui_str': 'Arteriosclerosis'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}]",,0.0458919,"Conversely, compared with baseline, the functional reach, gait speed, and timed up-and-go test results improved significantly after 6 months in this group; these improvements were maintained after 1 year.","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Mori', 'Affiliation': 'Department of Rehabilitation Sciences, Kansai University of Welfare Sciences, 3-11-1, Asahigaoka, Kashiwara City, Osaka, 582-0026, Japan.'}, {'ForeName': 'Takuo', 'Initials': 'T', 'LastName': 'Nomura', 'Affiliation': 'Department of Rehabilitation Sciences, Kansai University of Welfare Sciences, 3-11-1, Asahigaoka, Kashiwara City, Osaka, 582-0026, Japan. Electronic address: nomurata1017@yahoo.co.jp.'}, {'ForeName': 'Yoshiteru', 'Initials': 'Y', 'LastName': 'Akezaki', 'Affiliation': 'Department of Rehabilitation Sciences, Kansai University of Welfare Sciences, 3-11-1, Asahigaoka, Kashiwara City, Osaka, 582-0026, Japan.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Rehabilitation Sciences, Kansai University of Welfare Sciences, 3-11-1, Asahigaoka, Kashiwara City, Osaka, 582-0026, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Iwakura', 'Affiliation': 'Department of Rehabilitation Sciences, Kansai University of Welfare Sciences, 3-11-1, Asahigaoka, Kashiwara City, Osaka, 582-0026, Japan.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104011']
88,32131127,"A Randomized, Double-Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Patients with Visual Impairment due to Diabetic Macular Edema (KITE).","BACKGROUND


Brolucizumab is a single-chain variable antibody fragment (scVF) that specifically binds to VEGF-A. The results of two large phase III, multicentre, randomized clinical trials comparing intravitreal treatment with Brolucizumab and Aflibercept in neovascular age-related degeneration demonstrated its potency in the treatment of neovascular age-related macular degeneration (nAMD).
METHODS


The currently tested injected dose of 6 mg Brolucizumab results in a 11.2 - 13.3 times higher equivalent molar dose compared to Aflibercept 2 mg. Thus, it is conceivable that the effect of Brolucizumab in DME exceeds that of other currently used anti-VEGF agents with regards to effect durability; this was confirmed for nAMD in a phase I/II study.
RESULTS


Approved anti-VEGF drugs have shown unprecedented success compared to laser treatment with regards to restoration of visual acuity and improvement of diabetic retinopathy severity scores for up to 5 years. The visual gains were sustained after the loading phase and a reduced number of injections were required after the first year independent of the treatment strategy. Compared to pan-retinal laser photocoagulation, the time to progression of DRP was markedly extended and was proven by better preservation of the visual field, prevention of severe vision loss, hemorrhagic complications, and the need for intraocular surgery.
CONCLUSIONS


The ongoing prospective, randomized, phase III clinical studies in DME, KITE, and KESTREL aim to confirm the non-inferiority of Brolucizumab 6 mg compared to Aflibercept 2 mg on a functional and morphological level as well as durability effect over 2 years.",2020,The visual gains were sustained after the loading phase and a reduced number of injections were required after the first year independent of the treatment strategy.,"['Patients with Visual Impairment due to Diabetic Macular Edema (KITE', 'neovascular age-related macular degeneration (nAMD']","['pan-retinal laser photocoagulation', 'Brolucizumab versus Aflibercept', 'Brolucizumab and Aflibercept', 'Brolucizumab', 'Aflibercept']","['severe vision loss, hemorrhagic complications', 'diabetic retinopathy severity scores', 'Efficacy and Safety', 'visual gains']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0336865', 'cui_str': 'Kite, device (physical object)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0852815', 'cui_str': 'Laser photocoagulation to retina'}, {'cui': 'C4550124', 'cui_str': 'brolucizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]",,0.0738441,The visual gains were sustained after the loading phase and a reduced number of injections were required after the first year independent of the treatment strategy.,"[{'ForeName': 'Justus G', 'Initials': 'JG', 'LastName': 'Garweg', 'Affiliation': 'Clinic for Vitreoretinal Disease, Swiss Eye Institute, Bern, Switzerland.'}]",Klinische Monatsblatter fur Augenheilkunde,['10.1055/a-1101-9126']
89,31461720,The Cricothyroid versus Spray-As-You-Go Method for Topical Anesthesia during Flexible Bronchoscopy: The CRISP Randomized Clinical Trial.,"BACKGROUND


Comparative characteristics of the cricothyroid injection and spray-as-you-go methods for lidocaine administration during diagnostic flexible bronchoscopy are not clear.
OBJECTIVES


Co-primary outcomes were comparison of cough count from bronchoscope introduction until reaching carina and operator-rated overall procedure satisfaction on a Visual Analogue Scale (VAS) between groups. Secondary outcomes were cumulative lidocaine dose, procedure duration, assistant-rated cough, willingness to return for repeat procedure, and procedural complications between groups.
METHODS


Consecutive subjects were randomized (1:1) to either the cricothyroid or the spray-as-you-go method for topical anesthesia to the vocal cords and trachea. All received nasal 2% lidocaine gel and pharyngeal 10% lidocaine spray.
RESULTS


A total of 500 subjects were randomized, and 495 subjects were analyzed (248 cricothyroid and 247 spray-as-you-go). Cough count until reaching carina (median [range]) was significantly lower (cricothyroid, 1 [0-10], and spray-as-you-go, 4 [0-30], p < 0.0001) and operator-rated overall procedure satisfaction, VAS (mean ± standard deviation) (cricothyroid, 7.86 ± 1.39 and spray-as-you-go, 6.86 ± 1.59, p < 0.0001) significantly greater in the cricothyroid group. Patient willingness to return for repeat procedure was greater (87.1 vs. 70.5%, p < 0.001)) and cumulative lidocaine dose significantly lower (305.08 ± 13.40 vs. 322.18 ± 10.67 mg, p < 0.001) in the cricothyroid group. Minor complications occurred in 6 patients in the cricothyroid group and 9 patients in the spray-as-you-go group.
CONCLUSION


Cricothyroid lidocaine administration is associated with less cough and superior operator-rated procedure satisfaction during bronchoscopy at a lower cumulative lidocaine dose.",2019,"Patient willingness to return for repeat procedure was greater (87.1 vs. 70.5%, p < 0.001)) and cumulative lidocaine dose significantly lower (305.08 ± 13.40 vs. 322.18 ± 10.67 mg, p < 0.001) in the cricothyroid group.","['500 subjects were randomized, and 495 subjects were analyzed (248 cricothyroid and 247 spray-as-you-go', 'Consecutive subjects']","['lidocaine gel and pharyngeal 10% lidocaine spray', 'cricothyroid', 'Cricothyroid lidocaine', 'cricothyroid or the spray-as-you-go method for topical anesthesia to the vocal cords and trachea', 'lidocaine', 'cricothyroid injection and spray']","['Cough count until reaching carina (median [range', 'cough and superior operator-rated procedure satisfaction', 'cumulative lidocaine dose, procedure duration, assistant-rated cough, willingness to return for repeat procedure, and procedural complications between groups', 'Patient willingness to return for repeat procedure', 'Visual Analogue Scale (VAS', 'Minor complications']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4521772', 'cui_str': 'Spray'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0040578', 'cui_str': 'Trachea'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0225594', 'cui_str': 'Carina'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1141861', 'cui_str': 'Periprocedural complication'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",500.0,0.121758,"Patient willingness to return for repeat procedure was greater (87.1 vs. 70.5%, p < 0.001)) and cumulative lidocaine dose significantly lower (305.08 ± 13.40 vs. 322.18 ± 10.67 mg, p < 0.001) in the cricothyroid group.","[{'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Madan', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India, drkaranmadan@gmail.com.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Nishkarsh', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Onco-Anesthesia and Palliative Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Shiba Kalyan', 'Initials': 'SK', 'LastName': 'Biswal', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Pawan', 'Initials': 'P', 'LastName': 'Tiwari', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Hadda', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Guleria', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}]",Respiration; international review of thoracic diseases,['10.1159/000501563']
90,32146521,Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence.,"INTRODUCTION AND HYPOTHESIS


Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence.
METHODS


This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.
RESULTS


Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II.
CONCLUSIONS


Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.",2020,"Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse.","['women with advanced prolapse versus stage II prolapse', 'women with advanced prolapse (stage III-IV) and stress urinary incontinence', 'women with advanced vaginal prolapse', 'women with advanced pelvic organ prolapse and stress urinary incontinence', 'women with advanced prolapse', 'Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse']","['ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care', 'uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF', 'native tissue transvaginal apical approaches']","['Serious adverse events', 'individual success components', 'Surgical success, symptom severity, and overall serious adverse events', 'Prolapse symptom severity scores', 'individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0205990', 'cui_str': 'Vaginal Prolapse'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",374.0,0.18451,"Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse.","[{'ForeName': 'Isuzu', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA. imeyer@uabmc.edu.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Whitworth', 'Affiliation': 'RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Department of Reproductive Medicine, University of California-San Diego Health Systems, San Diego, CA, USA.'}, {'ForeName': 'Ariana L', 'Initials': 'AL', 'LastName': 'Smith', 'Affiliation': 'Department of Surgery, Division of Urology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Ackenbom', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Clifford Y', 'Initials': 'CY', 'LastName': 'Wai', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International urogynecology journal,['10.1007/s00192-020-04271-y']
91,32321478,Reducing expectations for antibiotics in primary care: a randomised experiment to test the response to fear-based messages about antimicrobial resistance.,"BACKGROUND


To reduce inappropriate antibiotic use, public health campaigns often provide fear-based information about antimicrobial resistance (AMR). Meta-analyses have found that fear-based campaigns in other contexts are likely to be ineffective unless respondents feel confident they can carry out the recommended behaviour ('self-efficacy'). This study aimed to test the likely impact of fear-based messages, with and without empowering self-efficacy elements, on patient consultations/antibiotic requests for influenza-like illnesses, using a randomised design.
METHODS


We hypothesised that fear-based messages containing empowering information about self-management without antibiotics would be more effective than fear alone, particularly in a pre-specified subgroup with low AMR awareness. Four thousand respondents from an online panel, representative of UK adults, were randomised to receive three different messages about antibiotic use and AMR, designed to induce fear about AMR to varying degrees. Two messages (one 'strong-fear', one 'mild-fear') also contained empowering information regarding influenza-like symptoms being easily self-managed without antibiotics. The main outcome measures were self-reported effect of information on likelihood of visiting a doctor and requesting antibiotics, for influenza-like illness, analysed separately according to whether or not the AMR information was 'very/somewhat new' to respondents, pre-specified based on a previous (non-randomised) survey.
RESULTS


The 'fear-only' message was 'very/somewhat new' to 285/1000 (28.5%) respondents, 'mild-fear-plus-empowerment' to 336/1500 (22.4%), and 'strong-fear-plus-empowerment' to 388/1500 (25.9%) (p = 0.002). Of those for whom the respective information was 'very/somewhat new', only those given the 'strong-fear-plus-empowerment' message said they would be less likely to request antibiotics if they visited a doctor for an influenza-like illness (p < 0.0001; 182/388 (46.9%) 'much less likely'/'less likely', versus 116/336 (34.5%) with 'mild-fear-plus-empowerment' versus 85/285 (29.8%) with 'fear-alone'). Those for whom the respective information was not 'very/somewhat new' said they would be less likely to request antibiotics for influenza-like illness (p < 0.0001) across all messages (interaction p < 0.0001 versus 'very/somewhat new' subgroup). The three messages had analogous self-reported effects on likelihood of visiting a doctor and in subgroups defined by believing antibiotics would 'definitely/probably' help an influenza-like illness. Results were reproduced in an independent randomised survey (additional 4000 adults).
CONCLUSIONS


Fear could be effective in public campaigns to reduce inappropriate antibiotic use, but should be combined with messages empowering patients to self-manage symptoms effectively without antibiotics.",2020,The three messages had analogous self-reported effects on likelihood of visiting a doctor and in subgroups defined by believing antibiotics would 'definitely/probably' help an influenza-like illness.,"['primary care', 'Four thousand respondents from an online panel, representative of UK adults']",[],"['self-reported effect of information on likelihood of visiting a doctor and requesting antibiotics, for influenza-like illness']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}]",4000.0,0.0931366,The three messages had analogous self-reported effects on likelihood of visiting a doctor and in subgroups defined by believing antibiotics would 'definitely/probably' help an influenza-like illness.,"[{'ForeName': 'Laurence S J', 'Initials': 'LSJ', 'LastName': 'Roope', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tonkin-Crine', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Herd', 'Affiliation': 'Centre for Behaviour Change, University College London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Centre for Behaviour Change, University College London, London, UK.'}, {'ForeName': 'Koen B', 'Initials': 'KB', 'LastName': 'Pouwels', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Castro-Sanchez', 'Affiliation': 'NIHR Health Protection Research Unit, Healthcare Associated Infection and Antimicrobial Resistance at Imperial College, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sallis', 'Affiliation': 'Public Health England, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hopkins', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Julie V', 'Initials': 'JV', 'LastName': 'Robotham', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Derrick W', 'Initials': 'DW', 'LastName': 'Crook', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Peters', 'Affiliation': 'Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'The National Institute for Health Research Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wordsworth', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK. sarah.wordsworth@ndph.ox.ac.uk.'}]",BMC medicine,['10.1186/s12916-020-01553-6']
92,31484659,"A Randomized, Placebo-Controlled, Double-Blind, Dose Escalation, Single Dose, and Steady-State Pharmacokinetic Study of 9cUAB30 in Healthy Volunteers.","9cUAB30 is a synthetic analogue of 9-cis retinoic acid with chemoprevention activity in cell lines and animal models. The purpose of this phase I placebo-controlled, double-blinded, dose escalation study of 9cUAB30 was to evaluate its safety, pharmacokinetics, and determine a dose for future phase II studies. Participants received a single dose of study drug (placebo or 9cUAB30) on day 1 followed by a 6-day drug-free period and then 28 days of continuous daily dosing starting on day 8. Fifty-three healthy volunteers were enrolled into five dose cohorts (20, 40, 80, 160, and 240 mg). Participants were randomized within each dose level to receive either 9cUAB30 ( n  = 8) or placebo ( n  = 2). 9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol. Treatment-emergent grade 3 hypertension occurred in 1 of 8 participants at the 20 mg dose level and in 2 of 8 at the 240 mg dose level, all considered unlikely related to study agent; no other grade 3 adverse events were observed. The AUC increased, as expected, between day 1 (single dose) and day 36 (steady state). Pharmacokinetics were linear in dose escalation through 160 mg. 9cUAB30 administered by daily oral dosing has a favorable safety and pharmacokinetic profile. On the basis of the observed safety profile and lack of linearity in pharmacokinetics at doses greater than 160 mg, the recommended phase II dose with the current formulation is 160 mg once daily.",2019,"9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol.","['Healthy Volunteers', 'Fifty-three healthy volunteers']","['placebo', 'Placebo', '9cUAB30', 'drug (placebo or 9cUAB30']","['grade 3 adverse events', 'serum triglycerides or cholesterol', 'grade 3 hypertension']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1311390', 'cui_str': '(9Z)-UAB30'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",53.0,0.180973,"9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol.","[{'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Kolesar', 'Affiliation': 'College of Pharmacy, University of Kentucky, Lexington, Kentucky. jill.kolesar@uky.edu hhb@medicine.wisc.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Andrews', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Green', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Tom C', 'Initials': 'TC', 'LastName': 'Havighurst', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Barbara W', 'Initials': 'BW', 'LastName': 'Wollmer', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Katina', 'Initials': 'K', 'LastName': 'DeShong', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Laux', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Krontiras', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'Muccio', 'Affiliation': 'Biochemistry and Molecular Genetics, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Clinton J', 'Initials': 'CJ', 'LastName': 'Grubbs', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Margaret G', 'Initials': 'MG', 'LastName': 'House', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Parnes', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Brandy M', 'Initials': 'BM', 'LastName': 'Heckman-Stoddard', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Bailey', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin. jill.kolesar@uky.edu hhb@medicine.wisc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0310']
93,32323190,Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the prevention of venous thromboembolism.,"Anticoagulant plasma concentrations and patient characteristics might affect the benefit-risk balance of therapy. The study objective was to assess the impact of model-predicted rivaroxaban exposure and patient characteristics on outcomes in patients receiving rivaroxaban for venous thromboembolism (VTE) prophylaxis (VTE-P) after hip/knee replacement surgery. Post hoc exposure-response analyses were conducted using data from the phase 3 RECORD1-4 studies, in which 12,729 patients were randomized to rivaroxaban 10 mg once daily or enoxaparin for ≤ 39 days. Multivariate regression approaches were used to correlate model-predicted individual rivaroxaban exposures and patient characteristics with outcomes. In the absence of measured rivaroxaban exposure, exposure estimates were predicted based on individual increases in prothrombin time (PT) and by making use of the known correlation between rivaroxaban plasma concentration and dynamics of PT. No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified. A significant association between exposure and a composite of major or non-major clinically relevant (NMCR) bleeding from day 4 after surgery was observed. The relationship was shallow, with an approximate predicted absolute increase in a composite of major or NMCR bleeding from 1.08 [95% confidence interval (CI) 0.76-1.54] to 2.18% (95% CI 1.51-3.17) at the 5th and 95th percentiles of trough plasma concentration, respectively. In conclusion, based on the underlying data and analysis, no reliable target window for exposure with improved benefit-risk could be identified within the investigated exposure range. Hence, monitoring rivaroxaban levels is unlikely to be beneficial in VTE-P.",2020,No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified.,"['12,729 patients', 'patients receiving rivaroxaban for venous thromboembolism (VTE) prophylaxis (VTE-P) after hip/knee replacement surgery']","['rivaroxaban', 'rivaroxaban 10\xa0mg once daily or enoxaparin']","['composite of major or NMCR bleeding', 'prothrombin time (PT', 'rivaroxaban exposure and total VTE or major bleeding', 'composite of major or non-major clinically relevant (NMCR) bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3162455', 'cui_str': 'rivaroxaban 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",12729.0,0.076615,No significant associations between rivaroxaban exposure and total VTE or major bleeding were identified.,"[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Reinecke', 'Affiliation': 'Bayer AB, Solna, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, 07981, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Peters', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'McMaster University, and the Thrombosis & Atherosclerosis Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Mueck', 'Affiliation': 'Clinical Pharmacokinetics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Garmann', 'Affiliation': 'Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, The University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Research & Development, Pharmaceuticals, 100 Bayer Boulevard, Whippany, NJ, 07981, USA. scott.berkowitz@bayer.com.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02078-8']
94,32304404,Stress Management Training Improves Overall Performance during Critical Simulated Situations: A Prospective Randomized Controlled Trial.,"BACKGROUND


High-fidelity simulation improves participant learning through immersive participation in a stressful situation. Stress management training might help participants to improve performance. The hypothesis of this work was that Tactics to Optimize the Potential, a stress management program, could improve resident performance during simulation.
METHODS


Residents participating in high-fidelity simulation were randomized into two parallel arms (Tactics to Optimize the Potential or control) and actively participated in one scenario. Only residents from the Tactics to Optimize the Potential group received specific training a few weeks before simulation and a 5-min reactivation just before beginning the scenario. The primary endpoint was the overall performance during simulation measured as a composite score (from 0 to 100) combining a specific clinical score with two nontechnical scores (the Ottawa Global Rating Scale and the Team Emergency Assessment Measure scores) rated for each resident by four blinded independent investigators. Secondary endpoints included stress level, as assessed by the Visual Analogue Scale during simulation.
RESULTS


Of the 134 residents randomized, 128 were included in the analysis. The overall performance (mean ± SD) was higher in the Tactics to Optimize the Potential group (59 ± 10) as compared with controls ([54 ± 10], difference, 5 [95% CI, 1 to 9]; P = 0.010; effect size, 0.50 [95% CI, 0.16 to 0.91]). After specific preparation, the median Visual Analogue Scale was 17% lower in the Tactics to Optimize the Potential group (52 [42 to 64]) than in the control group (63 [50 to 73]; difference, -10 [95% CI, -16 to -3]; P = 0.005; effect size, 0.44 [95% CI, 0.26 to 0.59].
CONCLUSIONS


Residents coping with simulated critical situations who have been trained with Tactics to Optimize the Potential showed better overall performance and a decrease in stress level during high-fidelity simulation. The benefits of this stress management training may be explored in actual clinical settings, where a 5-min Tactics to Optimize the Potential reactivation is feasible prior to delivering a specific intervention.",2020,"The overall performance (mean ± SD) was higher in the Tactics to Optimize the Potential group (59 ± 10) as compared with controls ([54 ± 10], difference, 5 [95% CI, 1 to 9]; P = 0.010; effect size, 0.50 [95% CI, 0.16 to 0.91]).","['Residents participating in high-fidelity simulation', '134 residents randomized', 'during Critical Simulated Situations']","['specific training', 'Stress management training', 'Stress Management Training', 'stress management training']","['median Visual Analogue Scale', 'overall performance (mean ± SD', 'stress level, as assessed by the Visual Analogue Scale during simulation', 'stress level', 'Overall Performance', 'overall performance during simulation measured as a composite score (from 0 to 100) combining a specific clinical score with two nontechnical scores (the Ottawa Global Rating Scale and the Team Emergency Assessment Measure scores) rated']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4517565', 'cui_str': '134'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]",134.0,0.0838857,"The overall performance (mean ± SD) was higher in the Tactics to Optimize the Potential group (59 ± 10) as compared with controls ([54 ± 10], difference, 5 [95% CI, 1 to 9]; P = 0.010; effect size, 0.50 [95% CI, 0.16 to 0.91]).","[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Sigwalt', 'Affiliation': 'From the Departments of Anesthesia and Intensive Care, Hospices Civils of Lyon, Lyon, France (F.S., G.P., D.C., J.-J.L., T.R., M.L.) Departments of Anesthesia and Intensive Care, Grenoble Alpes University Hospital, Grenoble, France (J.-N.E.) Institute of Biomedical Research, Armies\' Health Service, Bretigny sur Orge, France (D.C., M.T., F.C.) Desgenettes Hospital, Armies\' Health Service, Lyon, France (M.B.) Seventh Medical Center of the Armies of Lyon, 76th Medical Antenna of Varces, Varces, France (A.G.-L.) Claude Bernard Lyon 1 University, high fidelity medical simulation center (CLESS; Centre Lyonnais d\'Enseignement par Simulation en Santé), SAMSEI, Lyon, France (D.C., J.-J.L., T.R., M.L.) Health Data Department, Hospices Civils of Lyon, Lyon, France (A.D.) Claude Bernard Lyon 1 University, Health Services and Performance Research Lab (EA 7425 HESPER), Lyon, France (A.D., J.-J.L., M.L.) EA 7426 ""Pathophysiology of Injury-Induced Immunosuppression"" (Pi3), Claude Bernard Lyon 1 University-Biomérieux-Hospices Civils of Lyon, Lyon, France (T.R.) Val-de-Grâce School, Paris, France (M.T., F.C.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Petit', 'Affiliation': ''}, {'ForeName': 'Jean-Noel', 'Initials': 'JN', 'LastName': 'Evain', 'Affiliation': ''}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Claverie', 'Affiliation': ''}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Bui', 'Affiliation': ''}, {'ForeName': 'Angélique', 'Initials': 'A', 'LastName': 'Guinet-Lebreton', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Trousselard', 'Affiliation': ''}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Canini', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Chassard', 'Affiliation': ''}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Duclos', 'Affiliation': ''}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Lehot', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rimmelé', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lilot', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003287']
95,32304405,"Magnesium and Bladder Discomfort after Transurethral Resection of Bladder Tumor: A Randomized, Double-blind, Placebo-controlled Study.","BACKGROUND


Catheter-related bladder discomfort occurs because of involuntary contractions of the bladder smooth muscle after urinary catheterization. Magnesium is associated with smooth muscle relaxation. This study hypothesized that among patients having transurethral resection of bladder tumor, magnesium will reduce the incidence of postoperative moderate-to-severe catheter-related bladder discomfort.
METHODS


In this double-blind, randomized study, patients were randomly allocated to the magnesium group (n = 60) or the control group (n = 60). In magnesium group, a 50 mg/kg loading dose of intravenous magnesium sulfate was administered for 15 min, followed by an intravenous infusion of 15 mg · kg · h during the intraoperative period. Patients in the control group similarly received normal saline. The primary outcome was the incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively. None, mild, moderate, and severe catheter-related bladder discomfort at 1, 2, and 6 h postoperatively, patient satisfaction, and magnesium-related adverse effects were also assessed.
RESULTS


The incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively was significantly lower in the magnesium group than in the control group (13 [22%] vs. 46 [77%]; P < 0.001; relative risk = 0.283; 95% CI, 0.171 to 0.467; absolute risk reduction = 0.55; number needed to treat = 2); similar results were observed for catheter-related bladder discomfort above a moderate grade at 1 and 2 h postoperatively (5 [8%] vs. 17 [28%]; P = 0.005; relative risk = 0.294; 95% CI, 0.116 to 0.746; and 1 [2%] vs. 14 [23%]; P < 0.001; relative risk = 0.071; 95% CI, 0.010 to 0.526, respectively). Patient satisfaction on a scale from 1 to 7 was significantly higher in the magnesium group than in the control group (5.1 ± 0.8 vs. 3.5 ± 1.0; P < 0.001; 95% CI, 1.281 to 1.919). Magnesium-related adverse effects were not significantly different between groups.
CONCLUSIONS


Magnesium reduced the incidence of catheter-related bladder discomfort above a moderate grade and increased patient satisfaction among patients having transurethral resection of bladder tumor.",2020,"The incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively was significantly lower in the magnesium group than in the control group (13 [22%] vs. 46 [77%]; P < 0.001; relative risk = 0.283; 95% CI, 0.171 to 0.467; absolute risk reduction = 0.55; number needed to treat = 2); similar results were observed for catheter-related bladder discomfort above a moderate grade at 1 and 2 h postoperatively (5 [8%] vs. 17 [28%]; P = 0.005; relative risk = 0.294; 95% CI, 0.116 to 0.746; and 1 [2%] vs. 14 [23%]; P < 0.001; relative risk = 0.071; 95% CI, 0.010 to 0.526, respectively).","['after Transurethral Resection of Bladder Tumor', '120 patients recovering from transurethral resection of bladder tumor, intravenous', 'patients having transurethral resection of bladder tumor']","['magnesium', 'intravenous magnesium sulfate', 'normal saline', 'Magnesium', 'Placebo', 'Magnesium and Bladder Discomfort']","['patient satisfaction, and magnesium-related adverse effects', 'incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively', 'patient satisfaction', 'Magnesium-related adverse effects', 'bladder discomfort', 'Patient satisfaction', 'catheter-related bladder discomfort', 'mild, moderate, and severe catheter-related bladder discomfort', 'incidence of catheter-related bladder discomfort']","[{'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",120.0,0.63529,"The incidence of catheter-related bladder discomfort above a moderate grade at 0 h postoperatively was significantly lower in the magnesium group than in the control group (13 [22%] vs. 46 [77%]; P < 0.001; relative risk = 0.283; 95% CI, 0.171 to 0.467; absolute risk reduction = 0.55; number needed to treat = 2); similar results were observed for catheter-related bladder discomfort above a moderate grade at 1 and 2 h postoperatively (5 [8%] vs. 17 [28%]; P = 0.005; relative risk = 0.294; 95% CI, 0.116 to 0.746; and 1 [2%] vs. 14 [23%]; P < 0.001; relative risk = 0.071; 95% CI, 0.010 to 0.526, respectively).","[{'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (J.-Y.P.. D.-H.K., J.Y., J.-H.H., Y.-K.K.) the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (J.H.H.).'}, {'ForeName': 'Jun Hyuk', 'Initials': 'JH', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Doo-Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jihion', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Jai-Hyun', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': ''}, {'ForeName': 'Young-Kug', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003309']
96,32370760,The impact on selection of non-alcoholic vs alcoholic drink availability: an online experiment.,"BACKGROUND


Increasing the availability of healthier food increases its selection and consumption. However, there is an absence of evidence related to alcohol. This study aimed to estimate the impact of increasing the absolute and relative availability of non-alcoholic compared to alcoholic drinks on selection. We also assessed whether effects were modified by cognitive resource.
METHODS


UK adult weekly alcohol consumers (n = 808) were recruited to an online experiment with a hypothetical drink selection task. Participants were randomly assigned to one of eight conditions, in a 4 (availability) × 2 (cognitive resource) factorial design. The four availability conditions were: i. Reference 1 (two non-alcoholic, two alcoholic drinks); ii. Reference 2 (four non-alcoholic, four alcoholic drinks); iii. Increased non-alcoholic drinks (six non-alcoholic, two alcoholic drinks); iv. Increased alcoholic drinks (two non-alcoholic, six alcoholic drinks). The two cognitive resource conditions were: a. Low (high time pressure); b. High (low time pressure). Logistic regression was used to assess selection of a non-alcoholic drink.
RESULTS


49% of participants selected a non-alcoholic drink in the Increased non-alcoholic drinks condition, compared to 36% in Reference 1, 39% in Reference 2, and 26% in the Increased alcoholic drinks condition. Non-alcoholic drink selection was similar between Reference 1 and 2 when the total number of drinks increased (absolute availability) but the proportion of non-alcoholic compared to alcoholic drinks (relative availability) was unchanged (OR = 1.15, 95% CI 0.77, 1.73). In contrast, the odds of selecting a non-alcoholic drink were 71% higher when both absolute and relative availability of non-alcoholic compared to alcoholic drinks was increased from Reference 1 to the Increased non-alcoholic drinks condition (OR: 1.71, 95% CI 1.15, 2.54), and 48% higher when increased from Reference 2 to the Increased non-alcoholic drinks condition (OR: 1.48, 95% CI 0.99, 2.19). There was no evidence of an effect of cognitive resource.
CONCLUSIONS


Greater availability of non-alcoholic drinks, compared to alcoholic drinks, increased their online selection, an effect that may be larger when changing their relative availability, i.e., increasing the proportion of non-alcoholic drinks. Naturalistic studies are needed to determine the impact of availability interventions on reducing alcohol purchasing and consumption.",2020,"There was no evidence of an effect of cognitive resource.
","['Increased non-alcoholic drinks (six non-alcoholic, two alcoholic drinks', 'UK adult weekly alcohol consumers (n\u2009=\u2009808']","['alcoholic drinks', 'online experiment with a hypothetical drink selection task']","['Increased alcoholic drinks', 'alcoholic drink selection']","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]",808.0,0.115274,"There was no evidence of an effect of cognitive resource.
","[{'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, UK. anna.blackwell@bristol.ac.uk.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge, CB2 0SR, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School: Population Health Sciences, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Brocklebank', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, UK.'}, {'ForeName': 'Olivia M', 'Initials': 'OM', 'LastName': 'Maynard', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, UK.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Fletcher', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Forvie Site, Robinson Way, Cambridge, CB2 0SZ, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge, CB2 0SR, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, UK.'}]",BMC public health,['10.1186/s12889-020-08633-5']
97,32376640,Effect of yoga as add-on therapy in migraine (CONTAIN): A randomized clinical trial.,"OBJECTIVE


To evaluate the effectiveness of yoga as an adjuvant to conventional medical management on clinical outcomes in patients with migraine.
METHODS


CONTAIN was a prospective, randomized, open-label superiority trial with blinded endpoint assessment carried out at a single tertiary care academic hospital in New Delhi, India. Patients enrolled were aged 18-50 years with a diagnosis of episodic migraine and were randomized into medical and yoga groups (1:1). Randomization was computer-generated with a variable block size and concealed. A predesigned yoga intervention was given for 3 months. Outcomes were recorded by a blinded assessor. The primary endpoint was a decrease in headache frequency, headache intensity, and Headache Impact Test (HIT)-6 score. Secondary outcomes included change in Migraine Disability Assessment (MIDAS) score, pill count, and proportion of headache free patients.
RESULTS


Between April 2017 and August 2018, 160 patients with episodic migraine were randomly assigned to medical and yoga groups. A total of 114 patients completed the trial. Baseline measures were comparable except for a higher mean headache frequency in the yoga group. Compared to medical therapy, the yoga group showed a significant mean delta value reduction in headache frequency (delta difference 3.53 [95% confidence interval 2.52-4.54];  p  < 0.0001), headache intensity (1.31 [0.60-2.01];  p  = 0.0004), HIT score (8.0 [4.78-11.22];  p  < 0.0001), MIDAS score (7.85 [4.98-10.97];  p  < 0.0001), and pill count (2.28 [1.06-3.51];  p  < 0.0003).
CONCLUSION


Yoga as an add-on therapy in migraine is superior to medical therapy alone. It may be useful to integrate a cost-effective and safe intervention like yoga into the management of migraine.
CLINICALTRIALSGOV IDENTIFIER


CTRI/2017/03/008041.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that for patients with episodic migraine, yoga as adjuvant to medical therapy improves headache frequency, intensity, impact, and disability.",2020,"Compared to medical therapy, the yoga group showed a significant mean delta value reduction in headache frequency (delta difference 3.53 [95% confidence interval 2.52-4.54];  p  < 0.0001), headache intensity (1.31 [0.60-2.01];  p  = 0.0004), HIT score (8.0 [4.78-11.22];  p  < 0.0001), MIDAS score (7.85 [4.98-10.97];  p  < 0.0001), and pill count (2.28 [1.06-3.51];  p  < 0.0003).
","['migraine (CONTAIN', 'Between April 2017 and August 2018', '160 patients with episodic migraine', 'Patients enrolled were aged 18-50 years with a diagnosis of episodic migraine', 'patients with episodic migraine', 'patients with migraine', 'out at a single tertiary care academic hospital in New Delhi, India', '114 patients completed the trial']",['conventional medical management'],"['headache frequency, headache intensity, and Headache Impact Test (HIT)-6 score', 'change in Migraine Disability Assessment (MIDAS) score, pill count, and proportion of headache free patients', 'headache frequency', 'headache frequency, intensity, impact, and disability', 'MIDAS score', 'pill count', 'headache intensity', 'HIT score', 'mean headache frequency']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",160.0,0.114016,"Compared to medical therapy, the yoga group showed a significant mean delta value reduction in headache frequency (delta difference 3.53 [95% confidence interval 2.52-4.54];  p  < 0.0001), headache intensity (1.31 [0.60-2.01];  p  = 0.0004), HIT score (8.0 [4.78-11.22];  p  < 0.0001), MIDAS score (7.85 [4.98-10.97];  p  < 0.0001), and pill count (2.28 [1.06-3.51];  p  < 0.0003).
","[{'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Bhatia', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India. rohitbhatia71@yahoo.com.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Dhanlika', 'Initials': 'D', 'LastName': 'Dhanlika', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'Vishnubhatla', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Rajesh Kumar', 'Initials': 'RK', 'LastName': 'Singh', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Dash', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'Manjari', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}, {'ForeName': 'M V Padma', 'Initials': 'MVP', 'LastName': 'Srivastava', 'Affiliation': 'From the Department of Neurology (A.K., R.B.), Department of Cardiology (G.S.), Centre for Integrated Medicine and Research (CIMR) (D.D.), and Department of Biostatistics (S.V.), All India Institute of Medical Sciences (R.K.S., D.D., M.T., M.V.P.S.); and Cardio-thoracic Centre (G.S.), New Delhi, India.'}]",Neurology,['10.1212/WNL.0000000000009473']
98,32382043,"Pregnancy rates after slow-release insemination (SRI) and standard bolus intrauterine insemination (IUI) - A multicentre randomised, controlled trial.","This multicentre, randomised, controlled cross-over trial was designed to investigate the effect of intra-uterine slow-release insemination (SRI) on pregnancy rates in women with confirmed infertility or the need for semen donation who were eligible for standard bolus intra-uterine insemination (IUI). Data for a total of 182 women were analysed after randomisation to receive IUI (n = 96) or SRI (n = 86) first. The primary outcome was serological pregnancy defined by a positive beta human chorionic gonadotropin test, two weeks after insemination. Patients who did not conceive after the first cycle switched to the alternative technique for the second cycle: 44 women switched to IUI and 58 switched to SRI. In total, there were 284 treatment cycles (IUI: n = 140; SRI: n = 144). Pregnancy rates following SRI and IUI were 13.2% and 10.0%, respectively, which was not statistically significant (p = 0.202). A statistically significant difference in pregnancy rates for SRI versus IUI was detected in women aged under 35 years. In this subgroup, the pregnancy rate with SRI was 17% compared to 7% with IUI (relative risk 2.33; p = 0.032) across both cycles. These results support the hypothesis that the pregnancy rate might be improved with SRI compared to standard bolus IUI, especially in women aged under 35 years.",2020,"Pregnancy rates following SRI and IUI were 13.2% and 10.0%, respectively, which was not statistically significant (p = 0.202).","['Patients who did not conceive after the first cycle switched to the alternative technique for the second cycle: 44 women switched to IUI and 58 switched to SRI', 'women aged under 35 years', '182 women', 'women with confirmed infertility or the need for semen donation who were eligible for standard bolus intra-uterine insemination (IUI']","['slow-release insemination (SRI) and standard bolus intrauterine insemination (IUI) ', 'SRI', 'intra-uterine slow-release insemination (SRI']","['pregnancy rate with SRI', 'serological pregnancy defined by a positive beta human chorionic gonadotropin test', 'pregnancy rates', 'Pregnancy rates', 'Pregnancy rates following SRI and IUI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0106132', 'cui_str': 'Human chorionic gonadotropin, beta subunit'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}]",182.0,0.269693,"Pregnancy rates following SRI and IUI were 13.2% and 10.0%, respectively, which was not statistically significant (p = 0.202).","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Marschalek', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Egarter', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Vytiska-Binsdorfer', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Obruca', 'Affiliation': 'Kinderwunschzentrum Goldenes Kreuz, Lazarettgasse 16, 1090, Vienna, Austria.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Faculty of Health and Society, University of Northampton, Northampton, NN2 7AL, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Harris', 'Affiliation': 'Department of Gynaecology, Wrightington Hospital, Wigan, Lancashire, WN6 9EP, UK.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van Santen', 'Affiliation': 'Private Office and Spermbank, Kriegsstrasse 216, 76135, Karlsruhe, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Lesoine', 'Affiliation': 'A.R.T. Bogenhausen, Prinzregentenstraße 69, 81675, Munich, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Franz', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. mf@gyn-bogenhausen.de.'}]",Scientific reports,['10.1038/s41598-020-64164-4']
99,32384291,"Ketamine and Magnesium for Refractory Neuropathic Pain: A Randomized, Double-blind, Crossover Trial.","BACKGROUND


Ketamine is often used for the management of refractory chronic pain. There is, however, a paucity of trials exploring its analgesic effect several weeks after intravenous administration or in association with magnesium. The authors hypothesized that ketamine in neuropathic pain may provide pain relief and cognitive-emotional benefit versus placebo and that a combination with magnesium may have an additive effect for 5 weeks.
METHODS


A randomized, double-blind, crossover, placebo-controlled study (NCT02467517) included 20 patients with neuropathic pain. Each ketamine-naïve patient received one infusion every 35 days in a random order: ketamine (0.5 mg/kg)/placebo or ketamine (0.5 mg/kg)/magnesium sulfate (3g) or placebo/placebo.The primary endpoint was the area under the curve of daily pain intensity for a period of 35 days after infusion. Secondary endpoints included pain (at 7, 15, 21 and 28 days) and health-related, emotional, sleep, and quality of life questionnaires.
RESULTS


Daily pain intensity was not significantly different between the three groups (n = 20) over 35 days (mean area under the curve = 185 ± 100, 196 ± 92, and 187 ± 90 pain score-days for ketamine, ketamine/magnesium, and placebo, respectively, P = 0.296). The effect size of the main endpoint was -0.2 (95% CI [-0.6 to 0.3]; P = 0.425) for ketamine versus placebo, 0.2 (95% CI [-0.3 to 0.6]; P = 0.445) for placebo versus ketamine/magnesium and -0.4 (95% CI [-0.8 to 0.1]; P = 0.119) for ketamine versus ketamine/magnesium. There were no significant differences in emotional, sleep, and quality of life measures. During placebo, ketamine, and ketamine/magnesium infusions, 10%, 20%, and 35% of patients respectively reported at least one adverse event.
CONCLUSIONS


The results of this trial in neuropathic pain refuted the hypothesis that ketamine provided pain relief at 5 weeks and cognitive-emotional benefit versus placebo and that a combination with magnesium had any additional analgesic effect.",2020,"There were no significant differences in emotional, sleep, and quality of life measures.","['20 patients with neuropathic pain', 'Refractory Neuropathic Pain', '20 patients with chronic neuropathic painNo effect of either the']","['placebo, ketamine, and ketamine/magnesium', 'ketamine or ketamine + magnesium', 'ketamine (0.5 mg/kg)/placebo or ketamine (0.5 mg/kg)/magnesium sulfate (3g) or placebo/placebo', 'ketamine', 'Ketamine', 'Ketamine and Magnesium', 'ketamine, ketamine/magnesium', 'ketamine/magnesium', 'saline, ketamine, and ketamine + magnesium infusions', 'magnesium', 'placebo']","['pain (at 7, 15, 21 and 28 days) and health-related, emotional, sleep, and quality of life questionnaires', 'pain relief', 'area under the curve of daily pain intensity', 'emotional, sleep, and quality of life measures', 'Daily pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.768198,"There were no significant differences in emotional, sleep, and quality of life measures.","[{'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Pickering', 'Affiliation': 'From University Hospital Clermont-Ferrand, Inserm CIC 1405, Clinical Pharmacology Department, F-63000 Clermont-Ferrand, France (G.P., V.M., A.C., F.G.) Clermont Auvergne University, Inserm 1107, F-63000 Clermont-Ferrand, France (G.P.) University Hospital Clermont-Ferrand, Clinical Research and Innovation Department, F-63000 Clermont-Ferrand, France (B.P., C.L.) University Hospital of Clermont-Ferrand, Assessment and Treatment of Pain Center, F-63000 Clermont-Ferrand, France (F.M., A.B.-B., E.C., N.D.) University Hospital Clermont-Ferrand, Clinical Research/Temporary Authorization Department, F-63000 Clermont-Ferrand, France (L.B.).'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Morel', 'Affiliation': ''}, {'ForeName': 'Alexandrine', 'Initials': 'A', 'LastName': 'Corriger', 'Affiliation': ''}, {'ForeName': 'Fatiha', 'Initials': 'F', 'LastName': 'Giron', 'Affiliation': ''}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Marcaillou', 'Affiliation': ''}, {'ForeName': 'Assiya', 'Initials': 'A', 'LastName': 'Bidar-Beauvallot', 'Affiliation': ''}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Chandeze', 'Affiliation': ''}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': ''}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': ''}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Delage', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003345']
100,32387140,Religious Coping in Cancer: A Quantitative Analysis of Expressive Writing Samples From Patients With Renal Cell Carcinoma.,"CONTEXT


Past religiosity/spirituality (R/S) research has mainly relied on self-report instruments, which may result in self-presentation and defensive biases.
OBJECTIVES


To address these limitations, we reviewed the writing samples that were generated as part of an expressive writing (EW) trial, coded the samples for R/S content, and examined cross-sectional and prospective associations between R/S content and symptom and psychosocial outcomes.
METHODS


Participants diagnosed with renal cell carcinoma who were randomized to the EW arm completed a standard writing protocol. Before randomization, they completed validated measures of R/S, depressive symptoms, social support, fatigue, and sleep disturbances and one, four, and 10 months after completing the intervention. Writing samples were coded for positive and negative religious coping (RC), and personal (e.g., private prayer) and collective (e.g., church attendance) religious engagement (RE).
RESULTS


Of the 138 patients, 117 provided at least one writing sample, and 89% of participants made at least one R/S reference with 70% including at least one positive RC statement, and 45.3% revealed personal and 42.3% collective RE. Negative RC was rare (8%). Although positive RC and RE were significantly associated with the R/S Index (P < 0.01), negative RC was not. In prospective analyses, RE was associated with reduced cancer-related symptoms over time (P = 0.04), and negative RC was associated with increased psychological distress over time (P = 0.004).
CONCLUSION


Behavioral coding of EW samples supported the literature suggesting that positive RC is common among patients with cancer. Although negative RC may be relatively rare, it may be associated with psychological distress.",2020,"Although positive RC and RE were significantly associated with the R/S Index (P<.01), negative RC was not.","['Cancer', 'Participants diagnosed with renal cell carcinoma', 'cancer patients', 'patients with renal cell carcinoma']",['expressive writing arm completed a standard writing protocol'],"['psychological distress', 'R/S, depressive symptoms, social support, fatigue, and sleep disturbances', 'positive and negative religious coping (RC), and personal (e.g., private prayer) and collective (e.g., church attendance) religious engagement (RE']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0681189', 'cui_str': 'Religiosity'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0392356', 'cui_str': 'Prayer'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",138.0,0.0481885,"Although positive RC and RE were significantly associated with the R/S Index (P<.01), negative RC was not.","[{'ForeName': 'Santhosshi', 'Initials': 'S', 'LastName': 'Narayanan', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: snarayanan2@mdanderson.org.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Milbury', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.04.029']
101,32334845,"Efficacy and Safety of Proposed Bevacizumab Biosimilar BE1040V in Patients With Metastatic Colorectal Cancer: A Phase III, Randomized, Double-blind, Noninferiority Clinical Trial.","PURPOSE


The purpose of this study was to compare the efficacy and safety of a proposed bevacizumab biosimilar to those of the reference product in patients with metastatic colorectal cancer (mCRC).
METHODS


This Phase III, multicenter, randomized, double-blind (patient- and assessor-blind), active-controlled, 2-armed, parallel-group, noninferiority trial was conducted in patients with histologically verified colorectal cancer with evidence of at least 1 metastasis. Patients with mCRC were randomized 2:1 to receive 5 mg/kg IV of either study drug plus FOLFIRI-3 (with repeated irinotecan 100 mg/m 2  60-min infusion on day 3) or the reference drug plus FOLFIRI-3 every 2 weeks for 1 year. Progression-free survival (PFS) was the primary end point, and overall survival, objective response rate, and time to treatment failure as well as safety and immunogenicity were secondary end points. The population assessable for PFS was per protocol, and the intention-to-treat population was used for sensitivity analysis. Safety was assessed based on reports of adverse events, laboratory test results, and vital sign measurements.
FINDINGS


A total of 126 patients were enrolled; PFS values in the biosimilar and reference arms were 232 days (7.7 months) and 210 days (7 months), respectively (P = 0.47). The hazard ratio of the biosimilar arm versus the reference arm was 0.79 in the per-protocol population (90% CI, 0.46-1.35; P = 0.47). The upper limit for the 2-sided 90% CI was lower than the margin of 1.44, indicating that the biosimilar drug was noninferior to the reference drug. The hazard ratio for overall survival in the intent-to-treat population was 0.99 (95% CI, 0.55-1.80; P = 0.99). The difference between other efficacy end points among the groups was not statistically significant. No significant difference was observed in the comparison of the two arms for safety. The antidrug antibody was positive in 1 patient in each arm.
IMPLICATIONS


The proposed biosimilar BE1040V was noninferior to the reference product in terms of efficacy in the treatment of mCRC, and tolerability was comparable between the 2 drugs. ClinicalTrials.gov identifier: NCT03288987.",2020,"The proposed biosimilar BE1040V was noninferior to the reference product in terms of efficacy in the treatment of mCRC, and tolerability was comparable between the 2 drugs.","['126 patients were enrolled', 'Patients with mCRC', 'patients with metastatic colorectal cancer', 'patients with histologically verified colorectal cancer with evidence of at least 1 metastasis', 'patients with metastatic colorectal cancer (mCRC']","['bevacizumab biosimilar BE1040V', 'bevacizumab biosimilar']","['hazard ratio\xa0for overall survival', 'Progression-free survival (PFS', 'hazard ratio', 'efficacy and safety', 'adverse events, laboratory test results, and vital sign measurements', 'overall survival, objective response rate, and time to treatment failure as well as safety and immunogenicity', 'PFS values', 'Efficacy and safety']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",126.0,0.53901,"The proposed biosimilar BE1040V was noninferior to the reference product in terms of efficacy in the treatment of mCRC, and tolerability was comparable between the 2 drugs.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rezvani', 'Affiliation': 'Department of Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mohammadreza', 'Initials': 'SM', 'LastName': 'Mortazavizadeh', 'Affiliation': 'Department of Internal, Faculty of Medicine, Islamic Azad University, Yazd, Iran.'}, {'ForeName': 'Abolghasem', 'Initials': 'A', 'LastName': 'Allahyari', 'Affiliation': 'Division of Hematology and Medical Oncology, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Amirabbas', 'Initials': 'A', 'LastName': 'Nekuee', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Safa Najjar', 'Initials': 'SN', 'LastName': 'Najafi', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vahidfar', 'Affiliation': 'Yazd University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Ghadyani', 'Affiliation': 'Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khosravi', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Siroos', 'Initials': 'S', 'LastName': 'Qarib', 'Affiliation': 'Razi Hospital, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Esfandbod', 'Affiliation': 'Hematology-Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Rajaeinejad', 'Affiliation': 'AJA University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Rezvani', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hajiqolami', 'Affiliation': 'Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Payandeh', 'Affiliation': 'Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Shazad', 'Affiliation': 'Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Anjidani', 'Affiliation': 'Head of Medical Department, OrchidPharmed Company, Tehran, Iran.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Meskinimood', 'Affiliation': 'Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Alikhasi', 'Affiliation': 'Department of Radiology, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Moein', 'Initials': 'M', 'LastName': 'Karbalaeian', 'Affiliation': 'Division of General Medicine of Medical School of Shaheed Sadoughi Medical School of Yazd University, Yazd, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Salari', 'Affiliation': 'Department of Medical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: s.salari@sbmu.ac.ir.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.03.009']
102,32335056,Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses: 3-Year Results of a Randomized Trial.,"PURPOSE


To compare the incidence and intensity of posterior capsule opacification (PCO) and neodymium-yttrium-aluminum-garnet (Nd:YAG) capsulotomy rates between 2 similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs) that differ in the proprietary material characteristics and design features, over a period of 3 years.
DESIGN


Randomized, prospective, patient- and examiner-masked clinical trial with intraindividual comparison.
METHODS


Setting: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
PATIENT POPULATION


Eighty patients (160 eyes) had bilateral cataract surgery and received a Vivinex XY1 IOL in 1 eye and an AcrySof SN60WF IOL in the other eye.
OBSERVATION PROCEDURES


Follow-up examinations were performed 3 years after surgery. Digital retroillumination images were taken of each eye. The amount of PCO (score: 0-10) was assessed subjectively at the slit lamp and objectively using automated image analysis software (AQUA).
MAIN OUTCOME MEASURE


PCO score (scale, 0-10).
RESULTS


The mean objective PCO score of the Vivinex XY1 IOLs was 0.9 ± 0.8 compared to the PCO score of 1.4 ± 1.1 for the AcrySof SN60WF IOLs (P < .001). Three years postoperatively, 11.4% of patients had an Nd:YAG capsulotomy in the Vivinex XY1 eye and 18.6% had a capsulotomy in the AcrySof SN60WF eye (P = .23).
CONCLUSION


The new hydrophobic acrylic Vivinex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the AcrySof SN60WF IOL. The interaction of various factors such as hydrophobic material, smooth optic surface, and sharp posterior optic edge plays a key role in PCO development.",2020,The new hydrophobic acrylic Vininex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the Acrysof SN60WF IOL.,[' Eighty patients (160 eyes) had bilateral cataract surgery and received a'],"['posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates between two similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs', 'Vivinex XY1 IOL in one eye and an Acrysof SN60WF IOL in the other eye', 'hydrophobic acrylic intraocular lenses', 'neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy']","['PCO rates and lower YAG rates', 'mean objective PCO score', 'Posterior capsule opacification score (scale, 0-10']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}, {'cui': 'C0559530', 'cui_str': 'Open loop'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0598629', 'cui_str': 'Hydrophobicity'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.147149,The new hydrophobic acrylic Vininex XY1 IOL showed significantly lower PCO rates and lower YAG rates compared to the Acrysof SN60WF IOL.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Röggla', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. Electronic address: rupert.menapace@meduniwien.ac.at.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.04.011']
103,30904909,Management of Persistent Air Leaks Using Endobronchial Autologous Blood Patch and Spigot Occlusion: A Multicentre Randomized Controlled Trial in China.,"BACKGROUND


Optimal management of persistent air leaks (PALs) in patients with secondary spontaneous pneumothorax (SSP) remains controversial.
OBJECTIVE


To evaluate the efficacy and safety of endobronchial autologous blood plus thrombin patch (ABP) and bronchial occlusion using silicone spigots (BOS) in patients with SSP accompanied by alveolar-pleural fistula (APF) and PALs.
METHODS


This prospective multicentre randomized controlled trial compared chest tube-attached water-seal drainage (CTD), ABP, and BOS that were performed between February 2015 and June 2017 in one of six tertiary care hospitals in China. Patients diagnosed with APF experiencing PALs (despite 7 days of CTD) and inoperable patients were included. Outcome measures included success rate of pneumothorax resolution at the end of the observation period (further 14 days), duration of air leak stop, lung expansion, hospital stay, and complications.
RESULTS


In total, 150 subjects were analysed in three groups (CTD, ABP, BOS) of 50 each. At 14 days, 60, 82, and 84% of CTD, ABP, and BOS subjects, respectively, experienced full resolution of pneumothorax (p = 0.008). All duration outcome measures were significantly better in the ABP and BOS groups than in the CTD group (p < 0.016 for all). The incidence of adverse events, including chest pain, cough, and fever, was not significantly different. All subjects in the ABP and BOS groups experienced temporary haemoptysis. Spigot displacement occurred in 8% of BOS subjects.
CONCLUSION


ABP and BOS resulted in clinically meaningful outcomes, including higher success rate, duration of air leak stop, lung expansion, and hospital stay, with an acceptable safety profile.",2019,"ABP and BOS resulted in clinically meaningful outcomes, including higher success rate, duration of air leak stop, lung expansion, and hospital stay, with an acceptable safety profile.","['February 2015 and June 2017 in one of six tertiary care hospitals in China', '150 subjects were analysed in three groups (CTD, ABP, BOS) of 50 each', 'patients with SSP accompanied by alveolar-pleural fistula (APF) and PALs', 'patients with secondary spontaneous pneumothorax (SSP', 'Patients diagnosed with APF experiencing PALs (despite 7 days of CTD) and inoperable patients were included']","['CTD', 'chest tube-attached water-seal drainage (CTD), ABP, and BOS', 'Endobronchial Autologous Blood Patch and Spigot Occlusion', 'endobronchial autologous blood plus thrombin patch (ABP) and bronchial occlusion using silicone spigots (BOS']","['full resolution of pneumothorax', 'Spigot displacement', 'incidence of adverse events, including chest pain, cough, and fever', 'ABP and BOS', 'temporary haemoptysis', 'success rate of pneumothorax resolution at the end of the observation period (further 14 days), duration of air leak stop, lung expansion, hospital stay, and complications', 'higher success rate, duration of air leak stop, lung expansion, and hospital stay, with an acceptable safety profile']","[{'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1405128', 'cui_str': 'Pleural fistula'}, {'cui': 'C3161098', 'cui_str': 'Secondary spontaneous pneumothorax'}, {'cui': 'C3491832', 'cui_str': '(125I)APF'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0444471', 'cui_str': 'Endobronchial (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}]","[{'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0019079', 'cui_str': 'Hemoptysis'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",150.0,0.07809,"ABP and BOS resulted in clinically meaningful outcomes, including higher success rate, duration of air leak stop, lung expansion, and hospital stay, with an acceptable safety profile.","[{'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Zhang', 'Affiliation': ""Department of Respiration, Tangdu Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Yong-Hong', 'Initials': 'YH', 'LastName': 'Xie', 'Affiliation': ""Department of Respiration, Tangdu Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': ""Department of Respiration, Tangdu Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Wang-Ping', 'Initials': 'WP', 'LastName': 'Li', 'Affiliation': ""Department of Respiration, Tangdu Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Zeng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Fujian Medical University, Quanzhou, China.'}, {'ForeName': 'Shi-Yue', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Zhi-Guang', 'Initials': 'ZG', 'LastName': 'Liu', 'Affiliation': ""Department of Respiratory Medicine, Hunan Provincial People's Hospital, The First Affiliated Hospital of Hunan Normal University, Changsha, China.""}, {'ForeName': 'Hong-Wu', 'Initials': 'HW', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Meitan General Hospital, Beijing, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Department of Respiratory Medicine, Changhai Hospital, Navy Military Medical University, Shanghai, China.'}, {'ForeName': 'Fa-Guang', 'Initials': 'FG', 'LastName': 'Jin', 'Affiliation': ""Department of Respiration, Tangdu Hospital, Air Force Military Medical University, Xi'an, China, jinfag@fmmu.edu.cn.""}]",Respiration; international review of thoracic diseases,['10.1159/000495298']
104,31390641,Telemedicine Improves Continuous Positive Airway Pressure Adherence in Stroke Patients with Obstructive Sleep Apnea in a Randomized Trial.,"BACKGROUND


The prevalence of obstructive sleep apnea (OSA) is very high in stroke patients, whereas the acceptance of positive airway pressure (PAP) therapy is low. Although telemedicine offers new options to increase acceptance, effective concepts and patient groups are not yet known.
OBJECTIVE


The aim of this study was to investigate the effect of a telemedicine concept consisting of telemonitoring and support when usage time drops.
METHODS


PAP naive stroke patients with apnea-hypopnea index (AHI) >15 were randomized in a prospective parallel design comparing home therapy with standard care (SC) as opposed to telemedicine care (TC) over a period of 6 months. The TC group received a standardized phone call to offer help and advice if the average weekly usage of PAP fell below 4 h/night.
RESULTS


Eighty patients were included, 5 were lost to follow-up, 75 (20 females, age: 57.0 ± 9.9, body mass index: 30.9 ± 6.0 kg/m2, AHI: 39.4 ± 18.6) were evaluated. While inpatient usage was similar in both groups, a significant difference was identified after 6 months of receiving home therapy (TC: 4.4 ± 2.5 h, SC: 2.1 ± 2.2 h; p < 0.000063). On average, 4.7 ± 3.1 interventional phone calls were needed (173 calls in total, ranging from 0 to 10 calls per patient), primarily for the purpose of motivation (61.3%), mask problems (16.2%), nasopharyngeal complaints or humidification issues (11.2%), and technical questions (10.6%). Sleepiness (Epworth Sleepiness Scale [ESS]) differed significantly (TC: 3.7 + 3.2, SC: 6.1 + 4.1; p = 0.008), as well as systolic blood pressure, which was available in a subgroup of 55 patients (TC: 129.5 + 15.2 mm Hg, SC: 138.8 + 16.1 mm Hg; p = 0.034).
CONCLUSION


A concept of telemonitoring and short telephone calls from the sleep lab raised PAP therapy adherence significantly in a group of stroke patients with moderate to severe OSA.",2019,A concept of telemonitoring and short telephone calls from the sleep lab raised PAP therapy adherence significantly in a group of stroke patients with moderate to severe OSA.,"['Eighty patients were included, 5 were lost to follow-up, 75 (20 females, age: 57.0 ± 9.9, body mass index: 30.9 ± 6.0 kg/m2, AHI: 39.4 ± 18.6) were evaluated', 'PAP naive stroke patients with apnea-hypopnea index (AHI) >15', 'Stroke Patients with Obstructive Sleep Apnea', 'stroke patients with moderate to severe OSA']","['telemedicine', 'standardized phone call', 'telemonitoring and short telephone calls', 'Telemedicine', 'home therapy with standard care (SC) as opposed to telemedicine care (TC', 'telemedicine concept consisting of telemonitoring']","['systolic blood pressure', 'Sleepiness (Epworth Sleepiness Scale [ESS', 'nasopharyngeal complaints or humidification issues', 'Continuous Positive Airway Pressure Adherence']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]",80.0,0.0228253,A concept of telemonitoring and short telephone calls from the sleep lab raised PAP therapy adherence significantly in a group of stroke patients with moderate to severe OSA.,"[{'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Nilius', 'Affiliation': 'Evang. Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Maik', 'Initials': 'M', 'LastName': 'Schroeder', 'Affiliation': 'Evang. Kliniken Essen Mitte, Essen, Germany, m.schroeder@kem-med.com.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Domanski', 'Affiliation': 'Helios Klinik Hagen-Ambrock, Hagen, Germany.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Tietze', 'Affiliation': 'Helios Klinik Hagen-Ambrock, Hagen, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Schäfer', 'Affiliation': 'Helios Klinik Hagen-Ambrock, Hagen, Germany.'}, {'ForeName': 'Karl-Josef', 'Initials': 'KJ', 'LastName': 'Franke', 'Affiliation': 'MärkischeKliniken GmbH, Lüdenscheid, Germany.'}]",Respiration; international review of thoracic diseases,['10.1159/000501656']
105,32000046,Comparison of scapular kinematics and muscle strength between those with a positive and a negative Scapular Assistance Test.,"BACKGROUND


The Scapular Assistance Test was suggested to directly assess the influence of scapular motion on pain and indirectly measure the function of the scapular rotators. However, it is still not clear if individuals with a positive Scapular Assistance Test actually present changes in scapular motion and muscle strength. This study compared scapular kinematics and muscle strength between those with a positive Scapular Assistance Test and those with a negative Scapular Assistance Test.
METHODS


Fifty individuals with shoulder pain were randomly allocated to: positive (n = 25) or negative Scapular Assistance Test (n = 25) group. Scapular kinematics was measured during elevation and lowering of the arm. Strength of the serratus anterior and lower trapezius was also measured. Two-way analysis of variance was used to compare kinematics between groups. Unpaired Student's t-test and Mann-Whitney test were used to compare strength of serratus anterior and lower trapezius, respectively.
FINDINGS


There were no differences (P > 0.05) in scapular internal rotation and upward rotation between both groups. For scapular tilt, there was group main effect (P < 0.05) during elevation and lowering of the arm, whereas the positive Scapular Assistance Test group presented greater scapular anterior tilt. There was no difference (P > 0.05) in strength between groups.
INTERPRETATION


Individuals with a positive Scapular Assistance Test are more likely to present decreased scapular posterior tilt in those with shoulder pain. Strength of the scapular muscles seems to be same in those with a positive and a negative Scapular Assistance Test.",2020,There were no differences (P > 0.05) in scapular internal rotation and upward rotation between both groups.,['Fifty individuals with shoulder pain'],['negative Scapular Assistance Test'],"['scapular internal rotation and upward rotation', 'Scapular kinematics', 'scapular anterior tilt', 'scapular motion and muscle strength']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}, {'cui': 'C1282911', 'cui_str': 'Upward (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",50.0,0.0494324,There were no differences (P > 0.05) in scapular internal rotation and upward rotation between both groups.,"[{'ForeName': 'Larissa Pechincha', 'Initials': 'LP', 'LastName': 'Ribeiro', 'Affiliation': 'Laboratory of Analysis and Intervention of the Shoulder Complex, Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Rodrigo Py Gonçalves', 'Initials': 'RPG', 'LastName': 'Barreto', 'Affiliation': 'Laboratory of Analysis and Intervention of the Shoulder Complex, Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Natalia Duarte', 'Initials': 'ND', 'LastName': 'Pereira', 'Affiliation': 'Laboratory of Analysis and Intervention of the Shoulder Complex, Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, Brazil.'}, {'ForeName': 'Paula Rezende', 'Initials': 'PR', 'LastName': 'Camargo', 'Affiliation': 'Laboratory of Analysis and Intervention of the Shoulder Complex, Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, Brazil. Electronic address: prcamargo@ufscar.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2019.12.030']
106,31548595,Rate of change of circulating 25-hydroxyvitamin D following sublingual and capsular vitamin D preparations.,"BACKGROUND


Vitamin D is critical for skeletal health, and is increasingly associated with other pathologies encompassing gastrointestinal, immunological and psychological effects. A significant proportion of the population exhibits suboptimal levels of vitamin D, particularly in Northern latitudes in winter. Supplementation is advocated, but few data are available on achievable or typical rates of change. There has been considerable interest in the potential use of sublingual sprays for delivery of nutrient supplements, but data on efficacy remain sparse.
METHODS


A randomised, placebo-controlled, three-arm parallel design study was conducted in healthy volunteers (n = 75) to compare the rate of change of vitamin D status in response to vitamin D3 (3000 IU/day) supplementation in capsule and sublingual spray preparations over a 6-week period between January and April 2017. Blood 25(OH)D concentrations were measured after day 0, 3, 7, 14, 21 and 42 days of supplementation with 3000 IU per diem.
RESULTS


Baseline measurements show 25(OH)D deficiency (<30 nmol/l), insufficiency (31-46 nmol/l) and sufficiency (> 50 mmol/l) in 14.9, 44.6 and 40.5% of the participants, respectively. There was a significant elevation in blood concentrations of 25(OH)D in both of the treatment arms (capsule p = 0.003, spray p = 0.001) compared with control. The capsule and spray were equally efficacious. The rate of change ranged from 0.69 to 3.93 (capsule) and 0.64 to 3.34 (spray) nmol/L day with average change in blood 25(OH)D levels of 2 nmol/l/day. Rates followed a simple normal distribution in the study population (ks = 0.94 and 0.82 for capsule and spray, respectively). The data suggest that rates of change are higher in individuals with lower levels of 25(OH)D.
CONCLUSIONS


A sublingual vitamin D spray is an effective mode of delivery for supplementation in a healthy population. The data provide reference values and ranges for the rate of change of 25(OH)D for nutrikinetic analyses.",2019,"There was a significant elevation in blood concentrations of 25(OH)D in both of the treatment arms (capsule p = 0.003, spray p = 0.001) compared with control.","['individuals with lower levels of 25(OH)D', 'healthy volunteers (n\u2009=\u200975']","['placebo', 'sublingual and capsular vitamin D preparations', 'sublingual vitamin D spray', 'vitamin D3 (3000\u2009IU/day) supplementation in capsule and sublingual spray preparations']","['Rate of change of circulating 25-hydroxyvitamin D', 'rate of change of vitamin D status', 'blood concentrations of 25(OH)D', '25(OH)D deficiency', 'Blood 25(OH)D concentrations', 'blood 25(OH)D levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1273658', 'cui_str': 'Sublingual spray'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.205393,"There was a significant elevation in blood concentrations of 25(OH)D in both of the treatment arms (capsule p = 0.003, spray p = 0.001) compared with control.","[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Williams', 'Affiliation': 'Molecular Gastroenterology Research Group, Academic Unit of Surgical Oncology, Department of Oncology & Metabolism, University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Williams', 'Affiliation': 'Department of Oncology & Metabolism, University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK.'}, {'ForeName': 'Bernard M', 'Initials': 'BM', 'LastName': 'Corfe', 'Affiliation': 'Molecular Gastroenterology Research Group, Academic Unit of Surgical Oncology, Department of Oncology & Metabolism, University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK. b.m.corfe@sheffield.ac.uk.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0503-0']
107,30554211,The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration® Valve System in the Treatment of Severe Emphysema.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD) has become a leading cause of morbidity and mortality in China, with tobacco smoke, air pollution, and occupational biohazards being the major risk factors.
OBJECTIVES


The REACH trial is a multicenter, prospective, randomized controlled trial undertaken in China to assess the safety and effectiveness of the Spiration® Valve System (SVS) compared to standard medical care in COPD patients with severe emphysema.
METHODS


Patients with severe airflow obstruction, hyperinflation, and severe dyspnea with interlobar fissure integrity were evaluated for enrollment. A total of 107 subjects were randomized in a 2: 1 allocation ratio to either the treatment group (SVS valves and medical management) or the control group (medical management alone).
RESULTS


The 3-month primary endpoint showed statistically significant improvement in forced expiratory volume in 1 s in the treatment group compared to the control group (0.104 ± 0.18 vs. 0.003 ± 0.15 L, p = 0.001), with the difference being durable through 6 months. Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL). Exercise function and quality of life measures improved in the treatment group, but showed a deterioration in the control group. The serious adverse event (SAE) rate was 33% in the treatment group and 24.2% in the control group. The predominance of SAEs were acute exacerbations of COPD in both groups. There was 1 death in the control group and no deaths in the treatment group.
CONCLUSION


The SVS represents a novel approach for the treatment of severe emphysema with a clinically acceptable risk-benefit profile.",2019,Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL).,"['Chronic obstructive pulmonary disease (COPD', 'Severe Emphysema', 'Patients with severe airflow obstruction, hyperinflation, and severe dyspnea with interlobar fissure integrity were evaluated for enrollment', '107 subjects', 'COPD patients with severe emphysema']","['allocation ratio to either the treatment group (SVS valves and medical management) or the control group (medical management alone', 'Spiration® Valve System', 'Spiration® Valve System (SVS']","['lobe volume reduction', 'serious adverse event (SAE) rate', 'Exercise function and quality of life measures', 'safety and effectiveness', 'forced expiratory volume']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention (morphologic abnormality)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0332469', 'cui_str': 'Fissured (qualifier value)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",107.0,0.0542143,Statistically significant target lobe volume reduction was achieved at 3 months (mean change 684.4 ± 686.7 mL) and through 6 months (757.0 ± 665.3 mL).,"[{'ForeName': 'Shiyue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Guangfa', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Changhui', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Xinglin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Faguang', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': ""Tangdu Hospital, The Second Teaching Hospital of The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Huaping', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Shanghai Chest Hospital affiliated to Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'The Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Chengshui', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China.'}, {'ForeName': 'Liangan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""The General Hospital of the Chinese People's Liberation Army (301), Beijing, China.""}, {'ForeName': 'Chunxue', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Huahao', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'The Second Affiliated Hospital, ZheJiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Felix J F', 'Initials': 'FJF', 'LastName': 'Herth', 'Affiliation': 'Thoraxklinik and Translational Lung Research Center, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China, profnzmd@gmail.com.'}]",Respiration; international review of thoracic diseases,['10.1159/000494327']
108,32325162,Effects of an Individualized Comprehensive Rehabilitation Program on Impaired Postural Control in Women With Chronic Pelvic Pain: A Randomized Controlled Trial.,"OBJECTIVE


To assess the effectiveness of an individualized comprehensive rehabilitation program (ICPR) on impaired postural control, pain, self-perceived health status, and functionality in women with chronic pelvic pain.
DESIGN


Randomized controlled trial.
SETTING


Women with chronic pelvic pain were recruited from the Gynecology Department of the University Hospital San Cecilio in Granada, Spain.
PARTICIPANTS


Participants (N=38) who were randomly divided into 2 groups.
INTERVENTIONS


The intervention group received an 8-week ICRP, and the control group received a leaflet with ergonomic information.
MAIN OUTCOME MEASURES


The main outcomes included were postural control (Mini Balance Evaluation Systems [Mini BESTest] and timed Up and Go [TUG]), pain (Brief Pain Inventory), self-perceived health status (EuroQol 5 dimensions [EQ-5D]), and functionality (Oswestry Disability Index [ODI]).
RESULTS


Significant differences were found between groups in the Mini BESTest and TUG scores with large effect sizes. The Brief Pain Inventory, EQ-5D, and ODI also presented significant differences in the between-groups analysis, with better scores in the intervention group after treatment. In the follow-up analysis, significant differences were found between groups in the Mini BESTest (P<.001), the cognitive TUG subscale (P=.032), interference of pain (P<.001), anxiety and depression (P=.001), and visual analog scale EQ-5D (P=.026) subscales, as well as the ODI (P<.001).
CONCLUSIONS


Our results show significant improvements on postural control, pain, self-perceived health status, and functionality in women with chronic pelvic pain who received an 8-week ICRP.",2020,"Our results show significant improvements on postural control, pain, self-perceived health status and functionality in women with CPP that received an eight-week ICRP.","['Women with chronic pelvic pain were recruited from the Gynaecology Department of the ""Hospital San Cecilio"" in Granada', '38 participants were included in the study and randomly divided into two groups', 'women with CPP', 'women with chronic pelvic pain']","['Individualized Comprehensive Rehabilitation Program', 'eight-week ICRP and the control group received a leaflet with ergonomic information', 'Individualized Comprehensive Rehabilitation Program (ICPR']","['Mini BESTest and TUG scores', 'VAS EQ-5D', 'interference of pain (p<0.001), anxiety/depression', 'postural control (Mini Balance Evaluation Systems, Mini BESTest and Timed Up and Go Test, TUG), pain (Brief Pain Inventory, BPI), self-perceived health status (Euroqol-5dimensions, EQ-5D) and functionality (Oswestry Disability Index, ODI', 'postural control', 'BPI, EQ-5D and ODI', 'cognitive TUG subscale', 'postural control, pain, self-perceived health status and functionality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0587481', 'cui_str': 'Gynecology department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",38.0,0.0673424,"Our results show significant improvements on postural control, pain, self-perceived health status and functionality in women with CPP that received an eight-week ICRP.","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Rodríguez-Torres', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cabrera-Martos', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Prados-Román', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Granados-Santiago', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Valenza', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Granada, Granada, Spain. Electronic address: cvalenza@ugr.es.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.019']
109,30529387,Sorafenib with or without concurrent transarterial chemoembolization in patients with advanced hepatocellular carcinoma: The phase III STAH trial.,"BACKGROUND & AIMS


Sorafenib is first-line standard of care for patients with advanced hepatocellular carcinoma (HCC), yet it confers limited survival benefit. Therefore, we aimed to compare clinical outcomes of sorafenib combined with concurrent conventional transarterial chemoembolization (cTACE) vs. sorafenib alone in patients with advanced HCC.
METHODS


In this investigator-initiated, multicenter, phase III trial, patients were randomized to receive sorafenib alone (Arm S, n = 169) or in combination with cTACE on demand (Arm C, n = 170). Sorafenib was started within 3 days and cTACE within 7-21 days of randomization. The primary endpoint was overall survival (OS).
RESULTS


For Arms C and S, the median OS was 12.8 vs. 10.8 months (hazard ratio [HR] 0.91; 90% CI 0.69-1.21; p = 0.290); median time to progression, 5.3 vs. 3.5 months (HR 0.67; 90% CI 0.53-0.85; p = 0.003); median progression-free survival, 5.2 vs. 3.6 months (HR 0.73; 90% CI 0.59-0.91; p = 0.01); and tumor response rate, 60.6% vs. 47.3% (p = 0.005). For Arms C and S, serious (grade ≥3) adverse events occurred in 33.3% vs. 19.8% (p = 0.006) of patients and included increased alanine aminotransferase levels (20.3% vs. 3.6%), hyperbilirubinemia (11.8% vs. 3.0%), ascites (11.8% vs. 4.2%), thrombocytopenia (7.2% vs. 1.2%), anorexia (7.2% vs. 1.2%), and hand-foot skin reaction (10.5% vs. 11.4%). A post hoc subgroup analysis compared OS in Arm C patients (46.4%) receiving ≥2 cTACE sessions to Arm S patients (18.6 vs. 10.8 months; HR 0.58; 95% CI 0.40-0.82; p = 0.006).
CONCLUSION


Compared with sorafenib alone, sorafenib combined with cTACE did not improve OS in patients with advanced HCC. However, sorafenib combined with cTACE significantly improved time to progression, progression-free survival, and tumor response rate. Sorafenib alone remains the first-line standard of care for patients with advanced HCC.
LAY SUMMARY


For patients with advanced hepatocellular carcinoma requiring sorafenib therapy, co-administration with conventional transarterial chemoembolization did not improve overall survival compared to sorafenib alone. Therefore, sorafenib alone remains the first-line standard of care for patients with advanced hepatocellular carcinoma. Clinical Trial Number: NCT01829035.",2019,"However, sorafenib combined with cTACE significantly improved time to progression, progression-free survival, and tumor response rate.","['patients with advanced HCC', 'patients with advanced hepatocellular carcinoma (HCC', 'patients with advanced hepatocellular carcinoma requiring sorafenib therapy, co-administration with', 'patients with advanced hepatocellular carcinoma']","['conventional transarterial chemoembolization', 'sorafenib combined with concurrent conventional transarterial chemoembolization (cTACE) vs. sorafenib alone', 'Sorafenib', 'sorafenib', 'sorafenib alone (Arm S, n\u202f=\u202f169) or in combination with cTACE', 'Sorafenib with or without concurrent transarterial chemoembolization', 'sorafenib combined with cTACE']","['tumor response rate', 'hand-foot skin reaction', 'OS', 'ascites', 'median progression-free survival', 'median OS', 'overall survival (OS', 'anorexia', 'time to progression, progression-free survival, and tumor response rate', 'serious (grade ≥3) adverse events', 'alanine aminotransferase levels', 'hyperbilirubinemia', 'overall survival', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0020433', 'cui_str': 'Bilirubinemia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",,0.2063,"However, sorafenib combined with cTACE significantly improved time to progression, progression-free survival, and tumor response rate.","[{'ForeName': 'Joong-Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, Korea, South Korea. Electronic address: jwpark@ncc.re.kr.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, South Korea.'}, {'ForeName': 'Do Young', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Severance Hospital, South Korea.'}, {'ForeName': 'Si-Hyun', 'Initials': 'SH', 'LastName': 'Bae', 'Affiliation': ""The Catholic University of Korea, South Korea; Seoul St. Mary's Hospital, South Korea.""}, {'ForeName': 'Seung Woon', 'Initials': 'SW', 'LastName': 'Paik', 'Affiliation': 'Samsung Medical Center, South Korea.'}, {'ForeName': 'Youn-Jae', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Inje University Busan Paik Hospital, South Korea.'}, {'ForeName': 'Hwi Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'SNU Boramae Medical Center, South Korea.'}, {'ForeName': 'Han Chu', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center, University of Ulsan, South Korea.'}, {'ForeName': 'Sang Young', 'Initials': 'SY', 'LastName': 'Han', 'Affiliation': 'Dong-A University Hospital, South Korea.'}, {'ForeName': 'Jae Youn', 'Initials': 'JY', 'LastName': 'Cheong', 'Affiliation': 'Ajou University Hospital, South Korea.'}, {'ForeName': 'Oh Sang', 'Initials': 'OS', 'LastName': 'Kwon', 'Affiliation': 'Gachon University Gil Medical Center, South Korea.'}, {'ForeName': 'Jong Eun', 'Initials': 'JE', 'LastName': 'Yeon', 'Affiliation': 'Korea University Guro Hospital, South Korea.'}, {'ForeName': 'Bo Hyun', 'Initials': 'BH', 'LastName': 'Kim', 'Affiliation': 'National Cancer Center, Korea, South Korea.'}, {'ForeName': 'Jaeseok', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Keimyung University Dongsan Medical Center, South Korea.'}]",Journal of hepatology,['10.1016/j.jhep.2018.11.029']
110,31586170,Comment on: A trial of a mechanical device for the treatment of blepharospasm.,,2020,,[],['mechanical device'],[],[],"[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",[],,0.0269564,,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Go', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Anderson', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Bayan', 'Initials': 'B', 'LastName': 'Al Othman', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Lee', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA. aglee@houstonmethodist.org.'}]","Eye (London, England)",['10.1038/s41433-019-0621-x']
111,31217579,Management of primary pterygium with intra-lesional injection of 5 flurouracil and bevacizumab (Avastin).,"BACKGROUND


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


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


The injection of 5 fluorouracil and Avastin act synergistically to arrest progression and induce atrophy in primary pterygium. This is related to the effect of agents on fibroblasts, collagen, and vascular tissues. Such medical intervention is a safe and viable option in the management of primary pterygium though excision of residual tissue is still required in some cases. Longer follow up is needed to ascertain whether this will reduce the recurrence rate following excision.",2019,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","['primary pterygium', 'Fourteen eyes of 14 patients', 'primary pterygium with intra-lesional injection of 5', 'Sixteen eyes with primary pterygium']","['combined 5FU and Avastin injections', 'intralesional 5 fluorouracil and Avastin', 'primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF', 'fluorouracil and Avastin', 'flurouracil and bevacizumab (Avastin']","['Pterygium progression', 'vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I', 'redness', 'VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I', 'recurrence rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0243982', 'cui_str': 'Hyaluronan Receptors'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0193891,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples.
","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Ghoz', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Ross', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hogan', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK. harminder.dua@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-019-0493-0']
112,31999469,Reduction of Postoperative Hip Arthroscopy Pain With an Ultrasound-Guided Fascia Iliaca Block: A Prospective Randomized Controlled Trial.,"BACKGROUND


Ultrasound-guided fascia iliaca blocks have been used for pain control after hip arthroscopy. There is little evidence regarding their effectiveness in comparison with other pain control modalities in patients who have undergone hip arthroscopy.
PURPOSE


To compare the efficacy of ultrasound-guided fascia iliac block with intra-articular ropivacaine in controlling pain after hip arthroscopy.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


Between 2015 and 2017, patients (N = 95) undergoing hip arthroscopy were randomly assigned to 2 groups. The first group received an ultrasound-guided fascia iliaca block with 50 to 60 mL of 0.35% ropivacaine. The second group received an intra-articular injection of 20 mL of 0.5% ropivacaine at the completion of the surgical case. Primary outcomes were postoperative pain scores in the recovery room; at postanesthesia care unit (PACU) discharge; and at 2 weeks, 6 weeks, and 3 months. Secondary outcomes included intraoperative and PACU narcotic usage (converted to morphine equivalent use) as well as readmission rates, PACU recovery time, and postoperative nausea and vomiting.
RESULTS


Postoperative pain across all points did not significantly differ between the groups. Intraoperative and PACU narcotics did not differ significantly between the groups. Readmission rates, PACU recovery time, and postoperative nausea and vomiting did not significantly differ between the groups. There were no associated complications in either group.
CONCLUSION


Ultrasound-guided fascia iliaca block for hip arthroscopy had no clinical advantage when compared with onetime intra-articular ropivacaine injection.
REGISTRATION


NCT02365961 (ClinicalTrials.gov identifier).",2020,"Readmission rates, PACU recovery time, and postoperative nausea and vomiting did not significantly differ between the groups.","['Between 2015 and 2017, patients (N = 95) undergoing hip arthroscopy', 'patients who have undergone hip arthroscopy', 'pain control after hip arthroscopy']","['ultrasound-guided fascia iliac block with intra-articular ropivacaine', 'intra-articular injection of 20 mL of 0.5% ropivacaine', 'ultrasound-guided fascia iliaca block with 50 to 60 mL of 0.35% ropivacaine', 'Ultrasound-Guided Fascia Iliaca Block']","['intraoperative and PACU narcotic usage (converted to morphine equivalent use) as well as readmission rates, PACU recovery time, and postoperative nausea and vomiting', 'Readmission rates, PACU recovery time, and postoperative nausea and vomiting', 'Postoperative Hip Arthroscopy Pain', 'postoperative pain scores in the recovery room; at postanesthesia care unit (PACU) discharge', 'Postoperative pain', 'Intraoperative and PACU narcotics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517451', 'cui_str': 'Zero point three five'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care (regime/therapy)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",95.0,0.14735,"Readmission rates, PACU recovery time, and postoperative nausea and vomiting did not significantly differ between the groups.","[{'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Glomset', 'Affiliation': 'Steadman Hawkins Clinic of the Carolinas, Prisma Health-Upstate, Greenville, South Carolina, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Prisma Health-Upstate, Greenville, South Carolina, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Tokish', 'Affiliation': 'Mayo Clinic Arizona, Phoenix, Arizona, USA.'}, {'ForeName': 'Suzanne D', 'Initials': 'SD', 'LastName': 'Renfro', 'Affiliation': 'Prisma Health-Upstate, Greenville, South Carolina, USA.'}, {'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Seckel', 'Affiliation': 'Hawkins Foundation, Greenville, South Carolina, USA.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Adams', 'Affiliation': 'Hawkins Foundation, Greenville, South Carolina, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Folk', 'Affiliation': 'Steadman Hawkins Clinic of the Carolinas, Prisma Health-Upstate, Greenville, South Carolina, USA.'}]",The American journal of sports medicine,['10.1177/0363546519898205']
113,32053828,Global connectivity and local excitability changes underlie antidepressant effects of repetitive transcranial magnetic stimulation.,"Repetitive transcranial magnetic stimulation (rTMS) is a commonly- used treatment for major depressive disorder (MDD). However, our understanding of the mechanism by which TMS exerts its antidepressant effect is minimal. Furthermore, we lack brain signals that can be used to predict and track clinical outcome. Such signals would allow for treatment stratification and optimization. Here, we performed a randomized, sham-controlled clinical trial and measured electrophysiological, neuroimaging, and clinical changes before and after rTMS. Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays. To capture the rTMS-driven changes in connectivity and causal excitability, resting fMRI and TMS/EEG were performed before and after the treatment. Baseline causal connectivity differences between depressed patients and healthy controls were also evaluated with concurrent TMS/fMRI. We found that active, but not sham rTMS elicited (1) an increase in dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials. Global connectivity changes predicted clinical outcome, while both global connectivity and TMS/EEG changes tracked clinical outcome. In patients but not healthy participants, we observed a perturbed inhibitory effect of the dlPFC on the amygdala. Taken together, rTMS induced lasting connectivity and excitability changes from the site of stimulation, such that after active treatment, the dlPFC appeared better able to engage in top-down control of the amygdala. These measures of network functioning both predicted and tracked clinical outcome, potentially opening the door to treatment optimization.",2020,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"['Patients (N\u2009=\u200936', 'depressed patients and healthy controls', 'major depressive disorder (MDD']","['Repetitive transcranial magnetic stimulation (rTMS', 'active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC', 'TMS', 'repetitive transcranial magnetic stimulation', 'rTMS']","['connectivity and causal excitability, resting fMRI and TMS/EEG', 'global connectivity and TMS/EEG changes tracked clinical outcome', 'dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",36.0,0.0327488,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"[{'ForeName': 'Neir', 'Initials': 'N', 'LastName': 'Eshel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Keller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Mills-Finnerty', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Huemer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Psychiatry and Neurosciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carreon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Shpigel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McTeague', 'Affiliation': 'Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Maron-Katz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA. amitetkin@stanford.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0633-z']
114,32142484,Prevention of Severe Acute Pancreatitis With Cyclooxygenase-2 Inhibitors: A Randomized Controlled Clinical Trial.,"OBJECTIVES


Severe acute pancreatitis (SAP) is still a big challenge. Accumulated data showed that overexpression of cyclooxygenase-2 (COX-2) in acute pancreatitis and experimental pancreatitis could be attenuated with COX-2 inhibitors. This study was aimed to evaluate whether the occurrence of SAP could be prevented by selective COX-2 inhibitors.
METHODS


A total of 190 patients with predicted SAP were randomized into convention group or convention plus COX-2 inhibitors (C+COX-2-Is) group. Besides conventional treatment to all patients in 2 groups, parecoxib (40 mg/d intravenous injection for 3 days) and celecoxib (200 mg oral or tube feeding twice daily for 7 days) were sequentially administrated to the patients in the C+COX-2-Is group. The primary outcome was predefined as the occurrence of SAP. The serum levels of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) for all of the patients were measured.
RESULTS


The occurrence of SAP in the C+COX-2-Is group was decreased 47.08% compared with the convention group, 21.05% (20/95) vs 39.78% (37/93), P = 0.005. A reduction of late local complications was also shown in the C+COX-2-Is group, 18.95% (18/93) vs 34.41% (32/95), P = 0.016. The serum levels of IL-6 and TNF-α were significantly lower in the C+COX-2-Is group than those in the convention group, P < 0.05. Parecoxib relieved abdominal pain more rapidly and decreased the consumption of meperidine. An incremental reduction of cost for 1% decrease of SAP occurrence was RMB475.
DISCUSSION


Sequential administration of parecoxib and celecoxib in patients with predicted SAP obtained about half-reduction of SAP occurrence through decreasing serum levels of TNF-α and IL-6. This regimen presented good cost-effectiveness.",2020,"The serum levels of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) for all of the patients were measured.
","['Severe Acute Pancreatitis With Cyclooxygenase-2 Inhibitors', 'Severe acute pancreatitis (SAP', '190 patients with predicted SAP']","['Parecoxib', 'convention group or convention plus COX-2 inhibitors (C+COX-2-Is', 'parecoxib and celecoxib', 'celecoxib', 'parecoxib']","['late local complications', 'consumption of meperidine', 'serum levels of', 'SAP occurrence', 'abdominal pain', 'serum levels of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α', 'occurrence of SAP', 'IL-6 and TNF-α']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis (disorder)'}, {'cui': 'C1257954', 'cui_str': 'Cyclooxygenase 2 Inhibitors'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1257954', 'cui_str': 'Cyclooxygenase 2 Inhibitors'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]",190.0,0.060653,"The serum levels of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) for all of the patients were measured.
","[{'ForeName': 'Zhiyin', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Laboratory of Gastroenterology and Hepatology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': 'Laboratory of Gastroenterology and Hepatology, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Mingguang', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'West China School of Public Health, Sichuan University, Chengdu, China.'}, {'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Libin', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000529']
115,31559418,Impact of Multidomain Lifestyle Intervention on Frailty Through the Lens of Deficit Accumulation in Adults with Type 2 Diabetes Mellitus.,"BACKGROUND


Type 2 diabetes and obesity increase the accumulation of health deficits and may accelerate biological aging. Multidomain lifestyle interventions may mitigate against this.
METHODS


Within a large, randomized clinical trial of intensive lifestyle intervention including caloric restriction, increased physical activity, dietary counseling, and risk factor monitoring compared with diabetes support and education, we examined the accumulation of health deficits across 8 years. We used two complementary frailty indices (FIs) based on deficit accumulation, one modeled on work in the Systolic Blood Pressure Intervention Trial and the other including additional deficits related to obesity and type 2 diabetes mellitus. Differences between intervention groups and their consistency among subgroups were assessed with re-randomization tests.
RESULTS


Data from 4,859 adults (45-76 years at baseline, 59% female) were analyzed. Random assignment to intensive lifestyle intervention was associated with lower FI scores throughout follow-up as captured by areas under curves traced by longitudinal means (p ≤ .001), over which time mean (SE) differences between intervention groups averaged 5.8% (0.9%) and 5.4% (0.9%) for the two indices. At year 8, the percentage of participants classified as frail (FI > 0.21) was lower among intensive lifestyle intervention (39.8% and 54.5%) compared with diabetes support and education (42.7% and 60.9%) for both FIs (both p < .001). Intervention benefits were relatively greater for participants who were older, not obese, and without history of cardiovascular disease at baseline.
CONCLUSIONS


Eight years of multidomain lifestyle intervention create a buffer against the accumulation of age-related health deficits in overweight or obese adults with type 2 diabetes.ClinicalTrials.gov Identifier: NCT00017953.",2020,"Random assignment to intensive lifestyle intervention was associated with lower FI scores throughout follow-up as captured by areas under curves traced by longitudinal means (p ≤ .001), over which time mean (SE) differences between intervention groups averaged 5.8% (0.9%) and 5.4% (0.9%) for the two indices.","['participants who were older, not obese, and without history of cardiovascular disease at baseline', 'overweight or obese adults with type 2 diabetes', '4,859 adults (45-76 years at baseline, 59% female', 'Adults with Type 2 Diabetes Mellitus']","['multidomain lifestyle intervention', 'Multidomain lifestyle interventions', 'intensive lifestyle intervention including caloric restriction, increased physical activity, dietary counseling, and risk factor monitoring compared with diabetes support and education', 'Multidomain Lifestyle Intervention']","['intensive lifestyle intervention', 'lower FI scores']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0291176,"Random assignment to intensive lifestyle intervention was associated with lower FI scores throughout follow-up as captured by areas under curves traced by longitudinal means (p ≤ .001), over which time mean (SE) differences between intervention groups averaged 5.8% (0.9%) and 5.4% (0.9%) for the two indices.","[{'ForeName': 'Felicia R', 'Initials': 'FR', 'LastName': 'Simpson', 'Affiliation': 'Department of Mathematics, Winston-Salem State University, North Carolina.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Winston-Salem, North Carolina.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Nicklas', 'Affiliation': 'Department of Internal Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Kritchevsky', 'Affiliation': 'Department of Internal Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Bertoni', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ingram', 'Affiliation': 'Department of Mathematics, Winston-Salem State University, North Carolina.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ojeranti', 'Affiliation': 'Department of Mathematics, Winston-Salem State University, North Carolina.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Mathematics, Winston-Salem State University, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz197']
116,32187767,"""Take an HIV Test Kit Home"": A Pilot Randomized Controlled Trial Among HIV High-risk Urban ED Patients.",,2020,2-4  Developing methods to increase engagement for routine testing for them remains a top priority in the national HIV preventive strategy.,"['people who inject drugs, men who have sex with men (MSM), and heterosexuals at increased risk, should be screened for HIV at least once annually and sexually active MSM from testing every 3-6 months', 'HIV High-Risk Urban ED Patients']",[],[],"[{'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.214878,2-4  Developing methods to increase engagement for routine testing for them remains a top priority in the national HIV preventive strategy.,"[{'ForeName': 'Angie S', 'Initials': 'AS', 'LastName': 'Kim', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Anuj V', 'Initials': 'AV', 'LastName': 'Patel', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Gaydos', 'Affiliation': 'the, Department of Medicine, Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jett-Goheen', 'Affiliation': 'the, Department of Medicine, Division of Infectious Diseases, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Abrams', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'and the, Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Rothman', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'From the, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13968']
117,31367901,Epicardial Application of Hydrogel with Amiodarone for Prevention of Postoperative Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting.,"The objective of this study was to assess the safety and efficacy of local epicardial application of amiodarone-releasing hydrogel for prevention of postoperative atrial fibrillation (POAF) in patients after coronary artery bypass grafting. Patients were randomized into two groups: with the application of amiodarone-releasing hydrogel and the control group. It included 60 patients (47 males, 13 females) (mean age of 62 ± 8.5). POAF incidence differences were statistically significant between two groups: in the study group, the POAF incidence was 3.3%, while in the control group, the POAF incidence was 37% (p < 0.001). Statistically significant differences were revealed in the PQ interval duration. The risk of POAF incidence was calculated using the Cox regression model: the age and the application of amiodarone-releasing hydrogel application were statistically significant. Hospital length of stay in two groups was also different (р < 0.001). The age and the application of amiodarone-releasing hydrogel were statistically significant for POAF incidence.",2020,Hospital length of stay in two groups was also different (р < 0.001).,"['60 patients (47 males, 13 females) (mean age of 62\u2009±\u20098.5', 'Patients', 'After Coronary Artery Bypass Grafting', 'patients after coronary artery bypass grafting']","['amiodarone-releasing hydrogel', 'Hydrogel with Amiodarone', 'amiodarone-releasing hydrogel and the control group']","['Postoperative Atrial Fibrillation', 'PQ interval duration', 'POAF incidence differences', 'risk of POAF incidence', 'POAF incidence', 'Hospital length of stay', 'postoperative atrial fibrillation (POAF', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.019914,Hospital length of stay in two groups was also different (р < 0.001).,"[{'ForeName': 'O L', 'Initials': 'OL', 'LastName': 'Bockeria', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Kanametov', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Shvartz', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia. vashvarts@bakulev.ru.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Sokolskaya', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'D Sh', 'Initials': 'DS', 'LastName': 'Zhuginisov', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Sanakoev', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Bockeria', 'Affiliation': 'Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow, Russia.'}]",Journal of cardiovascular translational research,['10.1007/s12265-019-09905-1']
118,31975493,Anodal transcranial direct current stimulation and intermittent theta-burst stimulation improve deglutition and swallowing reproducibility in elderly patients with dysphagia.,"BACKGROUND


Dysphagia in the elderly, known as presbydysphagia, has become a relevant public health problem in several countries. Swallowing disorders may be a consequence of different neurological disorders (secondary presbydysphagia) or the expression of the aging process itself (primary presbydysphagia). We aimed to test the therapeutic potential of two different non-invasive brain stimulation (NIBS) techniques in subjects with primary or secondary presbydysphagia.
METHODS


A blinded randomized controlled trial with crossover design was carried out in 42 patients, randomly assigned to anodal transcranial direct current stimulation (tDCS) or intermittent theta-burst stimulation (TBS) group. Both tDCS and TBS were applied for 5 consecutive days over the right swallowing motor cortex. The swallowing function was assessed before and 1 and 3 months after the stimulation using the Dysphagia Outcome and Severity Scale (DOSS), scored based on clinical assessment and fiberoptic endoscopic evaluation of swallowing. An electrophysiological method was also applied to evaluate changes in the reproducibility of the swallowing behavior.
KEY RESULTS


Both real tDCS and TBS had beneficial effects on the swallowing function in patients with primary and secondary presbydysphagia. Anodal tDCS resulted in an improvement of 0.5 points in DOSS at 1-month follow-up (P = .014), whereas intermittent TBS induced an increase of 0.7 and 0.6 points at 1- and 3-month follow-up evaluations, respectively (P = .0001 and P = .005, respectively). Reproducibility of both the oral and pharyngeal phases of swallowing significantly increased at 1-month follow-up.
CONCLUSIONS AND INFERENCES


Our results suggest that non-invasive cortical stimulation may be useful for dysphagia recovery in elderly patients.",2020,"Reproducibility of both the oral and pharyngeal phases of swallowing significantly increased at 1-month follow-up.
","['elderly patients with dysphagia', 'subjects with primary or secondary presbydysphagia', 'patients with primary and secondary presbydysphagia', '42 patients', 'elderly patients']","['anodal transcranial direct current stimulation (tDCS) or intermittent theta-burst stimulation (TBS) group', 'invasive brain stimulation (NIBS) techniques', 'Anodal transcranial direct current stimulation and intermittent theta-burst stimulation', 'Anodal tDCS', 'TBS']","['DOSS', 'swallowing function', 'Reproducibility of both the oral and pharyngeal phases of swallowing', 'Dysphagia Outcome and Severity Scale (DOSS), scored based on clinical assessment and fiberoptic endoscopic evaluation of swallowing', 'deglutition and swallowing reproducibility', 'intermittent TBS']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C1692318', 'cui_str': 'Docusate'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C4707950', 'cui_str': 'Dysphagia Outcome and Severity Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]",42.0,0.0310444,"Reproducibility of both the oral and pharyngeal phases of swallowing significantly increased at 1-month follow-up.
","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Cosentino', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Tassorelli', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Prunetti', 'Affiliation': 'Clinical Neurophysiology Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Bertino', 'Affiliation': 'Department of Otolaryngology, University of Pavia, IRCCS Policlinico S. Matteo Foundation, Pavia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'De Icco', 'Affiliation': 'Neurorehabilitation Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Todisco', 'Affiliation': 'Clinical Neurophysiology Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Di Marco', 'Affiliation': 'Department of Biomedicine Neuroscience and Advanced Diagnostics, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Brighina', 'Affiliation': 'Department of Biomedicine Neuroscience and Advanced Diagnostics, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Schindler', 'Affiliation': 'Department of Clinical Sciences ""Luigi Sacco"", University of Milan, Milan, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'Section of Human Nutrition and Dietetics, Department of Public Health and Experimental and Forensic Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Fresia', 'Affiliation': 'Clinical Neurophysiology Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mainardi', 'Affiliation': 'Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Domenico A', 'Initials': 'DA', 'LastName': 'Restivo', 'Affiliation': 'Department of Neurology, Garibaldi Hospital, Catania, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Priori', 'Affiliation': ""Department of Neurological Sciences, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Sandrini', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Alfonsi', 'Affiliation': 'Clinical Neurophysiology Unit, IRCCS Mondino Foundation, Pavia, Italy.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13791']
119,31418329,"Transcendental meditation and hypothalamic-pituitary-adrenal axis functioning: a pilot, randomized controlled trial with young adults.","Transcendental meditation (TM) is effective in alleviating stress and anxiety and promoting well-being. While the underlying biological mechanisms of TM are not yet fully explored, the hypothalamic-pituitary-adrenal (HPA) axis represents an index providing important clues embodying the stress system cascade. In this pilot study, young adults were randomly assigned to TM training followed by 8 weeks of meditation practice or a wait-list control condition. TM was conducted over 8 weeks. Thirty-four young adult participants were randomized; 27 participants completed the HPA outcome assessments (41% male). To assess HPA axis functioning, salivary samples to assess cortisol awakening response (CAR) that were collected in the morning, both at baseline and at week-4. Salivary cortisol in the context of a social stressor using the Trier Social Stress Test (TSST) was collected at week-8. The results indicate that participants who were randomly assigned to TM had lower awakening salivary cortisol levels and a greater drop in CAR from baseline to week-4 than the control group. There were no significant differences in HPA axis functioning in the context of the TSST. Primary limitations of this randomized controlled trial were the small sample size, the use of a wait-list as opposed to an active control, and the limited scope of HPA axis assessments. The results of this pilot study provide tentative evidence that TM may impact biological stress system functioning and suggests that this may be a worthwhile avenue to continue to examine. It will also be useful to extend these findings to a broader array of meditative and mindful practices, particularly for those who are experiencing more distress.",2020,There were no significant differences in HPA axis functioning in the context of the TSST.,"['Young Adults', 'Thirty-four young adult participants were randomized; 27 participants completed the HPA outcome assessments (41% male', 'young adults']","['Transcendental Meditation (TM', 'TM', 'Transcendental Meditation and Hypothalamic-Pituitary-Adrenal Axis Functioning', 'TM training followed by eight weeks of meditation practice or a wait-list control condition']","['awakening salivary cortisol levels', 'Trier Social Stress Test (TSST', 'HPA axis functioning', 'HPA axis functioning, salivary samples to assess cortisol awakening response (CAR', 'CAR']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0085565', 'cui_str': 'Outcomes Assessment'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0150814', 'cui_str': 'Transcendental Meditation'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0150277'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}]",27.0,0.101923,There were no significant differences in HPA axis functioning in the context of the TSST.,"[{'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Klimes-Dougan', 'Affiliation': 'Department of Psychology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Li Shen', 'Initials': 'LS', 'LastName': 'Chong', 'Affiliation': 'Department of Psychology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Samikoglu', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Thai', 'Affiliation': 'Department of Psychology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Palistha', 'Initials': 'P', 'LastName': 'Amatya', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kathryn R', 'Initials': 'KR', 'LastName': 'Cullen', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2019.1656714']
120,32317591,Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019.,"OBJECTIVES


Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU. This study aimed to describe specific pathophysiological characteristics of acute respiratory distress syndrome from coronavirus disease 2019.
DESIGN


Prospective crossover physiologic study.
SETTING


ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019.
PATIENTS


Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019.
INTERVENTIONS


We performed a two-step positive end-expiratory pressure trial with change of 10 cm H2O in random order.
MEASUREMENTS AND MAIN RESULTS


At each positive end-expiratory pressure level, we assessed arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography. Potential for lung recruitment was assessed by the recently described recruitment to inflation ratio. In a subgroup of seven paralyzed patients, we also measured ventilation-perfusion mismatch at lower positive end-expiratory pressure by electrical impedance tomography. At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure. Oxygenation and ventilation inhomogeneity improved but arterial CO2 increased despite unchanged respiratory rate and tidal volume. The recruitment to inflation ratio presented median value higher than previously reported in acute respiratory distress syndrome patients but with large variability (median, 0.79 [0.53-1.08]; range, 0.16-1.40). The FIO2 needed to obtain viable oxygenation at lower positive end-expiratory pressure was significantly correlated with the recruitment to inflation ratio (r = 0.603; p = 0.05). The ventilation-perfusion mismatch was elevated (median, 34% [32-45%] of lung units) and, in six out of seven patients, ventilated nonperfused units represented a much larger proportion than perfused nonventilated ones.
CONCLUSIONS


In patients with acute respiratory distress syndrome from coronavirus disease 2019, potential for lung recruitment presents large variability, while elevated dead space fraction may be a specific pathophysiological trait. These findings may guide selection of personalized mechanical ventilation settings.",2020,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","['Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019', 'patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome from coronavirus disease 2019', 'ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019', 'Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019', 'Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU']",['Lung Recruitment and Ventilation-Perfusion Mismatch'],"['arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography', 'respiratory rate and tidal volume', 'ventilation-perfusion mismatch']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]",10.0,0.127794,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Basile', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Crotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tubiolo', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Tagliabue', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zanella', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Critical care medicine,['10.1097/CCM.0000000000004386']
121,32312223,Stroke Prevention With the PCSK9 (Proprotein Convertase Subtilisin-Kexin Type 9) Inhibitor Evolocumab Added to Statin in High-Risk Patients With Stable Atherosclerosis.,"Background and Purpose- The PCSK9 (proprotein convertase subtilisin-kexin type 9) monoclonal antibody evolocumab lowered LDL (low-density lipoprotein) cholesterol by 59% to 0.8 (0.5-1.2) mmol/L and significantly reduced major vascular events in the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk). Herein, we report the results of a prespecified analysis of cerebrovascular events in the overall trial population and in patients stratified by prior stroke. Methods- FOURIER was a randomized, double-blind trial comparing evolocumab versus placebo in patients with established atherosclerosis, additional risk factors, and LDL cholesterol levels ≥1.8 (or non-HDL [high-density lipoprotein] ≥2.6 mmol/L) on statin therapy. The median follow-up was 2.2 years. We analyzed the efficacy of evolocumab to reduce overall stroke and stroke subtypes, as well as the primary cardiovascular composite end point by subgroups according to a history of stroke. Results- Among the 27 564 patients, 469 (1.7%) experienced a total of 503 strokes of which 421 (84%) were ischemic. Prior ischemic stroke, diabetes mellitus, elevated CRP (C-reactive protein), history of heart failure, older age, nonwhite race, peripheral arterial disease, and renal insufficiency were independent predictors of stroke. Evolocumab significantly reduced all stroke (1.5% versus 1.9%; hazard ratio, 0.79 [95% CI, 0.66-0.95];  P =0.01) and ischemic stroke (1.2% versus 1.6%; hazard ratio, 0.75 [95% CI, 0.62-0.92];  P =0.005), with no difference in hemorrhagic stroke (0.21% versus 0.18%; hazard ratio, 1.16 [95% CI, 0.68-1.98];  P =0.59). These findings were consistent across subgroups, including among the 5337 patients (19%) with prior ischemic stroke in whom the hazard ratios (95% CIs) were 0.85 (0.72-1.00) for the cardiovascular composite, 0.90 (0.68-1.19) for all stroke, and 0.92 (0.68-1.25) for ischemic stroke ( P  interactions, 0.91, 0.22, and 0.09, respectively, compared with patients without a prior ischemic stroke). Conclusions- Inhibition of PCSK9 with evolocumab added to statin in patients with established atherosclerosis reduced ischemic stroke and cardiovascular events in the total population and in key subgroups, including those with prior ischemic stroke. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01764633.",2020,"Evolocumab significantly reduced all stroke (1.5% versus 1.9%; hazard ratio, 0.79 [95% CI, 0.66-0.95];  P =0.01) and ischemic stroke (1.2% versus 1.6%; hazard ratio, 0.75 [95% CI, 0.62-0.92];  P =0.005), with no difference in hemorrhagic stroke (0.21% versus 0.18%; hazard ratio, 1.16 [95% CI, 0.68-1.98];  P =0.59).","['27 564 patients, 469 (1.7%) experienced a total of 503 strokes of which 421 (84%) were ischemic', 'High-Risk Patients With Stable Atherosclerosis', 'patients stratified by prior stroke', 'patients with established atherosclerosis reduced', 'Subjects with Elevated Risk', 'patients with established atherosclerosis, additional risk factors, and LDL cholesterol levels ≥1.8 (or non-HDL [high-density lipoprotein] ≥2.6 mmol/L) on statin therapy']","['PCSK9 (Proprotein Convertase Subtilisin-Kexin Type 9', 'evolocumab', 'Methods', 'evolocumab versus placebo', ' and Purpose', 'PCSK9 with evolocumab added to statin', 'Inhibitor Evolocumab Added to Statin']","['hemorrhagic stroke', 'stroke', 'ischemic stroke', 'ischemic stroke and cardiovascular events', 'Prior ischemic stroke, diabetes mellitus, elevated CRP (C-reactive protein), history of heart failure, older age, nonwhite race, peripheral arterial disease, and renal insufficiency', 'major vascular events', 'LDL (low-density lipoprotein) cholesterol', 'Stroke Prevention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C1426592', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 gene'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertase'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'Kexin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}]",27564.0,0.379903,"Evolocumab significantly reduced all stroke (1.5% versus 1.9%; hazard ratio, 0.79 [95% CI, 0.66-0.95];  P =0.01) and ischemic stroke (1.2% versus 1.6%; hazard ratio, 0.75 [95% CI, 0.62-0.92];  P =0.005), with no difference in hemorrhagic stroke (0.21% versus 0.18%; hazard ratio, 1.16 [95% CI, 0.68-1.98];  P =0.59).","[{'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""From the TIMI (Thrombolysis in Myocardial Infarction) Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G., E.A.B., S.A.M., M.S.S.).""}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo Universitetssykehus HF, Endocrinology-Morbid Obesity and Preventive Medicine, Norway (T.R.P.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at UCLA, Los Angeles, CA (J.L.S.).'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, United Kingdom (P.S.S.).'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, Australia (A.C.K.).'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Bohula', 'Affiliation': ""From the TIMI (Thrombolysis in Myocardial Infarction) Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G., E.A.B., S.A.M., M.S.S.).""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""From the TIMI (Thrombolysis in Myocardial Infarction) Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G., E.A.B., S.A.M., M.S.S.).""}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Wasserman', 'Affiliation': 'Amgen, Inc, Global Development, Thousand Oaks, CA (S.M.W., N.H., H.W., A.L.P.).'}, {'ForeName': 'Narimon', 'Initials': 'N', 'LastName': 'Honarpour', 'Affiliation': 'Amgen, Inc, Global Development, Thousand Oaks, CA (S.M.W., N.H., H.W., A.L.P.).'}, {'ForeName': 'Huei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Amgen, Inc, Global Development, Thousand Oaks, CA (S.M.W., N.H., H.W., A.L.P.).'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Lira Pineda', 'Affiliation': 'Amgen, Inc, Global Development, Thousand Oaks, CA (S.M.W., N.H., H.W., A.L.P.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""From the TIMI (Thrombolysis in Myocardial Infarction) Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G., E.A.B., S.A.M., M.S.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.027759']
122,32320729,Randomized in situ trial on the efficacy of Carbopol in enhancing fluoride / stannous anti-erosive properties.,"OBJECTIVE


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


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


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


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


Under highly erosive and abrasive conditions, rinsing with solutions containing sodium fluoride plus stannous chloride, associated or not with the Carbopol polymer, is an effective approach to control enamel erosive wear.",2020,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"['Cylindrical bovine enamel specimens', 'enamel erosive wear']","['sodium fluoride plus stannous chloride', 'FS (500\u2009ppm F- +800\u2009ppm', 'sodium fluoride with stannous chloride (FS) solution', 'Carbopol', 'bioadhesive polymer (Carbopol 980', 'palatal appliance containing 4 specimens: two were submitted to an erosion model (2\u2009h of pellicle formation; immersion in 1% citric acid, pH 2.3, for 5\u2009min, 4x/day; 1\u2009h intervals of saliva exposure']",['enamel loss'],"[{'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0108434', 'cui_str': 'Carbopol'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1542809', 'cui_str': 'Carbopol 980'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}]",,0.0322465,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"[{'ForeName': 'Daniele Mara da Silva', 'Initials': 'DMDS', 'LastName': 'Ávila', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: daniele-mara@uol.com.br.'}, {'ForeName': 'Rayssa Ferreira', 'Initials': 'RF', 'LastName': 'Zanatta', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil; Department of Restorative Dentistry, Dental School, University of Taubaté, Taubaté, Brazil. Electronic address: zanatta.rayssa@gmail.com.'}, {'ForeName': 'Tais', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, São Paulo University-USP, São Paulo, Brazil. Electronic address: tais.sca@usp.br.'}, {'ForeName': 'Idalina Vieira', 'Initials': 'IV', 'LastName': 'Aoki', 'Affiliation': 'Department of Chemical Engineering, Polytechnic School, São Paulo University-USP, São Paulo, Brazil. Electronic address: idavaoki@usp.br.'}, {'ForeName': 'Carlos Rocha Gomes', 'Initials': 'CRG', 'LastName': 'Torres', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: carlos.rg.torres@unesp.br.'}, {'ForeName': 'Alessandra Bühler', 'Initials': 'AB', 'LastName': 'Borges', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: alessandra.buhler@unesp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103347']
123,31177885,Effects of prefrontal transcranial direct current stimulation on autonomic and neuroendocrine responses to psychosocial stress in healthy humans.,"Prolonged or repeated activation of the stress response can have negative psychological and physical consequences. The prefrontal cortex (PFC) is thought to exert an inhibitory influence on the activity of autonomic and neuroendocrine stress response systems. In this study, we further investigated this hypothesis by increasing PFC excitability using transcranial direct current stimulation (tDCS). Healthy male participants were randomized to receive either anodal (excitatory) tDCS ( n  = 15) or sham stimulation ( n  = 15) over the left dorsolateral prefrontal cortex (DLPFC) immediately before and during the exposure to a psychosocial stress test. Autonomic (heart rate (HR) and its variability) and neuroendocrine (salivary cortisol) parameters were assessed. One single session of excitatory tDCS over the left DLPFC (i) reduced HR and favored a larger vagal prevalence prior to stress exposure, (ii) moderated stress-induced HR acceleration and sympathetic activation/vagal withdrawal, but (iii) had no effect on stress-induced cortisol release. However, anodal tDCS over the left DLPFC prevented stress-induced changes in the cortisol awakening response. Finally, participants receiving excitatory tDCS reported a reduction in their levels of state anxiety upon completion of the psychosocial stress test. In conclusion, this study provides first insights into the efficacy of one single session of excitatory tDCS over the left DLPFC in attenuating autonomic and neuroendocrine effects of psychosocial stress exposure. These findings might be indicative of the important role of the left DLPFC, which is a cortical target for noninvasive brain stimulation treatment of depression, for successful coping with stressful stimuli.",2020,"Finally, participants receiving excitatory tDCS reported a reduction in their levels of state anxiety upon completion of the psychosocial stress test.","['healthy humans', 'Healthy male participants']","['anodal (excitatory) tDCS ( n \u2009=\u200915) or sham stimulation ( n \u2009=\u200915) over the left dorsolateral prefrontal cortex (DLPFC', 'prefrontal transcranial direct current stimulation', 'excitatory tDCS', 'transcranial direct current stimulation (tDCS']","['cortisol awakening response', 'autonomic and neuroendocrine responses', 'state anxiety', 'stress-induced cortisol release', 'PFC excitability', 'Autonomic (heart rate (HR) and its variability) and neuroendocrine (salivary cortisol) parameters']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0126739,"Finally, participants receiving excitatory tDCS reported a reduction in their levels of state anxiety upon completion of the psychosocial stress test.","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Carnevali', 'Affiliation': 'Department of Chemistry, Life Sciences and Environmental Sustainability, Stress Physiology Lab, University of Parma, Parma, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pattini', 'Affiliation': 'Centro per la Cura, la Diagnosi e lo Studio dei Disturbi della Comunicazione e della Socializzazione, Ausl Parma, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sgoifo', 'Affiliation': 'Department of Chemistry, Life Sciences and Environmental Sustainability, Stress Physiology Lab, University of Parma, Parma, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ottaviani', 'Affiliation': 'Department of Psychology, Sapienza University of Rome, Rome, Italy.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2019.1625884']
124,31364435,"Executive Control, Cytokine Reactivity to Social Stress, and Depressive Symptoms: Testing the Social Signal Transduction Theory of Depression.","Social Signal Transduction Theory of Depression hypothesizes that social stress upregulates inflammatory activity, which in turn contributes to depression for some individuals. However, the specific cognitive processes underlying social stress-induced increases in inflammatory activity remain unclear. We addressed this issue by examining two separate relations: (1) between executive control measured following a laboratory-based social stress induction and individuals' pro-inflammatory cytokine responses to the same stress induction and (2) between pro-inflammatory cytokine responses and participants' depressive symptom levels. Healthy young participants ( M age  = 18.58 years old) were randomly assigned to either a stress condition or control condition. Executive control, and the inflammatory cytokines interleukin-1β, interleukin-6, and tumor necrosis factor-α, were measured before and after the social stress induction or control task. Regression analyses (stress condition,  n  = 20; control condition,  n  = 16) demonstrated that in the stress condition only, greater increases in interleukin-6 were associated with more depressive symptoms. Additional analyses in the stress condition ( n  = 16) indicated that greater impairment in executive control following the social stress induction was related to greater social stress-induced increases in interleukin-6. These findings are consistent with Social Signal Transduction Theory of Depression and with the hypothesis that impairment in executive control during times of stress may be one process that contributes to stress-induced inflammatory activity, which may in turn increase risk for depression.Lay SummarySocial Signal Transduction Theory of Depression hypothesizes that social stress upregulates inflammatory activity, which in turn contributes to depression, and that cognitive processes play a role in structuring these effects. Consistent with this theory, greater social stress-induced increases in the inflammatory cytokine interleukin-6 were associated with more depressive symptoms. In addition, greater impairment in executive control following the social stress induction was related to greater social stress-induced increases in interleukin-6, highlighting potential links between social stress, cognition, inflammation, and depression.",2020,Additional analyses in the stress condition ( n  = 16) indicated that greater impairment in executive control following the social stress induction was related to greater social stress-induced increases in interleukin-6.,['Healthy young participants ( M age \u2009=\u200918.58 years old'],['stress condition or control condition'],"['social stress-induced increases in interleukin-6', 'depressive symptoms', 'inflammatory cytokine interleukin-6', 'Executive Control, Cytokine Reactivity to Social Stress, and Depressive Symptoms', 'interleukin-6', 'Executive control, and the inflammatory cytokines interleukin-1β, interleukin-6, and tumor necrosis factor-α', 'social stress, cognition, inflammation, and depression']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0150376,Additional analyses in the stress condition ( n  = 16) indicated that greater impairment in executive control following the social stress induction was related to greater social stress-induced increases in interleukin-6.,"[{'ForeName': 'Meghan E', 'Initials': 'ME', 'LastName': 'Quinn', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University.'}, {'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Stanton', 'Affiliation': 'Department of Psychology, Yale University.'}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Slavich', 'Affiliation': 'Cousins Center for Psychoneuroimmunology and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Joormann', 'Affiliation': 'Department of Psychology, Yale University.'}]","Stress (Amsterdam, Netherlands)",['10.1080/10253890.2019.1641079']
125,32105221,Can different etching protocols change the properties of a hybrid ceramic?,"The aim of this study was to evaluate the effects of different concentrations of hydrofluoric acid (HF) and etching times on the flexural strength, roughness, wettability, and type of failure of a hybrid ceramic (VITA ENAMIC). Blocks of the ceramic material were made according to the norms of International Organization for Standardization standard 6872:2015 and randomly divided into 7 groups (n = 13): control (no treatment); surface etching with 5% HF for 30 (HF5-30), 60 (HF5-60), or 90 (HF5-90) seconds; and surface etching with 10% HF for 30 (HF10-30), 60 (HF10-60), or 90 (HF10-90) seconds. The adhesive surface of 10 specimens in each group was cemented with dual-curing resin cement. The specimens were submitted to biaxial flexural tests and fractographic analysis. Surface analyses were carried out using 3 noncemented specimens from each group. The surface roughness was evaluated through optical profilometry and the surface wettability through goniometry (contact angle). The values obtained were analyzed by a Dunnett test followed by 2-way analysis of variance and Tukey test (α = 5%). The flexural test results indicated a statistically significant reduction in the resistance of the ceramic when conditioned with 10% acid (P < 0.01). Etching with HF, at any concentration used for any applied time, significantly modified the ceramic roughness of the experimental groups (P < 0.01). The wettability was also significantly altered in the HF5-90 group and in all HF10 groups (P < 0.01). The higher the concentration of the acid, the lower the wettability of the ceramic (P < 0.01). Based on these results, a 5% HF concentration is best indicated for the surface treatment of VITA ENAMIC.",2020,"The higher the concentration of the acid, the lower the wettability of the ceramic (P < 0.01).",[],"['control (no treatment); surface etching with 5% HF', 'hydrofluoric acid (HF']","['wettability', 'resistance of the ceramic', 'ceramic roughness', 'flexural strength, roughness, wettability, and type of failure of a hybrid ceramic (VITA ENAMIC']",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0020274', 'cui_str': 'Hydrofluoric Acid'}]","[{'cui': 'C0162598', 'cui_str': 'Hygroscopicity'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C4704755', 'cui_str': 'Flexural Properties'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C4508227', 'cui_str': 'VITA Enamic'}]",,0.0153937,"The higher the concentration of the acid, the lower the wettability of the ceramic (P < 0.01).","[{'ForeName': 'Jean Soares', 'Initials': 'JS', 'LastName': 'Miranda', 'Affiliation': ''}, {'ForeName': 'Jaiane Bandoli', 'Initials': 'JB', 'LastName': 'Monteiro', 'Affiliation': ''}, {'ForeName': 'Pollyanna Nogueira Ferreira', 'Initials': 'PNF', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Márcia Carneiro', 'Initials': 'MC', 'LastName': 'Valera', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bresciani', 'Affiliation': ''}, {'ForeName': 'Renata Marques', 'Initials': 'RM', 'LastName': 'Melo', 'Affiliation': ''}]",General dentistry,[]
126,32314120,Retention in HIV Care Among HIV-Seropositive Pregnant and Postpartum Women in Uganda: Results of a Randomized Controlled Trial.,"We tested an intervention that aimed to increase retention in antiretroviral therapy (ART) among HIV-positive pregnant and postpartum women, a population shown to be vulnerable to poor ART outcomes. 133 pregnant women initiating ART at 2 hospitals in Uganda used real time-enabled wireless pill monitors (WPM) for 1 month, and were then randomized to receive text message reminders (triggered by late dose-taking) and data-informed counseling through 3 months postpartum or standard care. We assessed ""full retention"" (proportion attending all monthly clinic visits and delivering at a study facility; ""visit retention"" (proportion of clinic visits attended); and ""postpartum retention"" (proportion retained at 3 months postpartum). Intention-to-treat and per protocol analyses found that retention was relatively low and similar between groups, with no significant differences. Retention declined significantly post-delivery. The intervention was unsuccessful in this population, which experiences suboptimal ART retention and is in urgent need of effective interventions.",2020,"We tested an intervention that aimed to increase retention in antiretroviral therapy (ART) among HIV-positive pregnant and postpartum women, a population shown to be vulnerable to poor ART outcomes.","['HIV-Seropositive Pregnant and Postpartum Women in Uganda', 'HIV Care', '133 pregnant women initiating ART at 2 hospitals in Uganda used real time-enabled wireless pill monitors (WPM) for 1\xa0month', 'HIV-positive pregnant and postpartum women']","['antiretroviral therapy (ART', 'text message reminders (triggered by late dose-taking) and data-informed counseling through 3\xa0months postpartum or standard care']",[],"[{'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],133.0,0.179961,"We tested an intervention that aimed to increase retention in antiretroviral therapy (ART) among HIV-positive pregnant and postpartum women, a population shown to be vulnerable to poor ART outcomes.","[{'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Sabin', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA. lsabin@bu.edu.'}, {'ForeName': 'Nafisa', 'Initials': 'N', 'LastName': 'Halim', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Davidson H', 'Initials': 'DH', 'LastName': 'Hamer', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Simmons', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Sivani', 'Initials': 'S', 'LastName': 'Jonnalagadda', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Larson Williams', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Chemusto', 'Affiliation': 'Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Allen L', 'Initials': 'AL', 'LastName': 'Gifford', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Bonawitz', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Aroda', 'Affiliation': 'Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'DeSilva', 'Affiliation': 'Westbrook College of Health Professions, University of New England, Portland, ME, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gasuza', 'Affiliation': 'Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mukasa', 'Affiliation': 'Mildmay Uganda, Kampala, Uganda.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Messersmith', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Crosstown Center, 3rd Floor, Boston, MA, 02118, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02875-5']
127,32314514,"Randomized clinical trial: Effects of Aloe barbadensis Mill. extract on symptoms, fecal microbiota and fecal metabolite profiles in patients with irritable bowel syndrome.","BACKGROUND


Aloe barbadensis Mill. (Aloe) with potential prebiotic effects has been suggested to reduce symptoms in patients with irritable bowel syndrome (IBS). We therefore aimed to determine the effects of an Aloe extract on symptoms of IBS, and evaluate whether effects may be mediated by fecal microbiota and metabolites in a randomized, double-blind, controlled trial.
METHODS


Patient with IBS diagnosed according to the ROME III criteria (all subtypes), received Aloe or control treatment (inulin) for 4 weeks. IBS Symptom Severity Score (IBS-SSS) was assessed, and fecal samples collected before and at end of treatment. Fecal microbiota composition and metabolomic profile were determined.
KEY RESULTS


In total, 160 IBS patients completed the study. The overall severity of IBS symptoms was reduced in both Aloe and control treatment groups (P < .001, both groups, comparing baseline vs end of treatment), without difference between groups (P = .62). The frequency of responders (IBS-SSS reduction ≥ 50) did not differ between Aloe treatment (n = 33, 39%) and control (n = 34, 45%) (P = .49). However, fecal microbiota and metabolite profiles differed between Aloe, but not control treatment responders and non-responders both before and after treatment.
CONCLUSION


In a mixed group of IBS patients, Aloe was not superior to control treatment, although it showed potential to reduce IBS symptom severity in subsets of IBS patients which could be predicted by fecal microbiota and metabolite profiles. ClinicalTrials.gov no: NCT01400048.",2020,"The overall severity of IBS symptoms was reduced in both Aloe and control treatment groups (P < .001, both groups, comparing baseline vs end of treatment), without difference between groups (P = .62).","['patients with irritable bowel syndrome (IBS', 'patients with irritable bowel syndrome', '160 IBS patients completed the study', 'Patient with IBS diagnosed according to the ROME III criteria (all subtypes), received']","['Aloe extract', 'Aloe barbadensis Mill', 'Aloe or control treatment (inulin']","['IBS Symptom Severity Score (IBS-SSS', 'Fecal microbiota composition and metabolomic profile', 'symptoms, fecal microbiota and fecal metabolite profiles', 'overall severity of IBS symptoms', 'IBS symptom severity', 'fecal microbiota and metabolite profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}]","[{'cui': 'C0304554', 'cui_str': 'Aloe Extract'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0002168', 'cui_str': 'Aloe'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",160.0,0.1365,"The overall severity of IBS symptoms was reduced in both Aloe and control treatment groups (P < .001, both groups, comparing baseline vs end of treatment), without difference between groups (P = .62).","[{'ForeName': 'Bani', 'Initials': 'B', 'LastName': 'Ahluwalia', 'Affiliation': 'Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Maria K', 'Initials': 'MK', 'LastName': 'Magnusson', 'Affiliation': 'Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Böhn', 'Affiliation': 'Calmino Group AB, Gothenburg, Sweden.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Störsrud', 'Affiliation': 'Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Larsson', 'Affiliation': 'Calmino Group AB, Gothenburg, Sweden.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Savolainen', 'Affiliation': 'Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Ross', 'Affiliation': 'Department of Biology and Biological Engineering, Chalmers University of Technology, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Simrén', 'Affiliation': 'Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Öhman', 'Affiliation': 'Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13860']
128,32314781,Dual-Outcome Intention-to-Treat Analyses in the Women's Health Initiative Randomized Controlled Hormone Therapy Trials.,"Dual-outcome intention-to-treat hazard rate analyses have potential to complement single-outcome analyses for the evaluation of treatments or exposures in relation to multivariate time-to-response outcomes. Here we consider pairs formed from important clinical outcomes to obtain further insight into influences of menopausal hormone therapy on chronic disease. As part of the Women's Health Initiative, randomized, placebo-controlled hormone therapy trials of conjugated equine estrogens (CEE) among posthysterectomy participants and of these same estrogens plus medroxyprogesterone acetate (MPA) among participants with an intact uterus were carried out at 40 US clinical centers (1993-2016). These data provide the context for analyses covering the trial intervention periods and a nearly 20-year (median) cumulative duration of follow-up. The rates of multiple outcome pairs were significantly influenced by hormone therapy, especially over cumulative follow-up, providing potential clinical and mechanistic insights. For example, among women randomized to either regimen, hazard ratios for pairs defined by fracture during intervention followed by death from any cause were reduced and hazard ratios for pairs defined by gallbladder disease followed by death were increased, though these findings may primarily reflect single-outcome associations. In comparison, hazard ratios for diabetes followed by death were reduced with CEE but not with CEE + MPA, and those for hypertension followed by death were increased with CEE + MPA but not with CEE.",2020,"In comparison, hazard ratios for diabetes followed by death were reduced with CEE but not with CEE+MPA, and for hypertension followed by death were increased with CEE+MPA but not with CEE.",['participants with uterus'],"['conjugated equine estrogens (CEE', 'estrogens plus medroxyprogesterone acetate (CEE+MPA', 'CEE+MPA', 'placebo']",['hazard ratios for diabetes followed by death'],"[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}]","[{'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.125359,"In comparison, hazard ratios for diabetes followed by death were reduced with CEE but not with CEE+MPA, and for hypertension followed by death were increased with CEE+MPA but not with CEE.","[{'ForeName': 'Ross L', 'Initials': 'RL', 'LastName': 'Prentice', 'Affiliation': ''}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Aragaki', 'Affiliation': ''}, {'ForeName': 'Rowan T', 'Initials': 'RT', 'LastName': 'Chlebowski', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Jacques E', 'Initials': 'JE', 'LastName': 'Rossouw', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Banack', 'Affiliation': ''}, {'ForeName': 'Aladdin H', 'Initials': 'AH', 'LastName': 'Shadyab', 'Affiliation': ''}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'Beverly M', 'Initials': 'BM', 'LastName': 'Snively', 'Affiliation': ''}, {'ForeName': 'Margery', 'Initials': 'M', 'LastName': 'Gass', 'Affiliation': ''}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ''}]",American journal of epidemiology,['10.1093/aje/kwaa033']
129,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND


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


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


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


Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3']
130,31160805,Efficacy and safety of periprostatic nerve block combined with perineal subcutaneous anaesthesia and intrarectal lidocaine gel in transrectal ultrasound guided transperineal prostate biopsy: A Prospective Randomised Controlled Trial.,"BACKGROUND


To determine the efficacy and safety of a periprostatic nerve block combined with perineum subcutaneous anaesthesia and intrarectal lidocaine gel for transrectal ultrasound-guided transperineal prostate biopsy (TPBx) through a prospective randomised controlled trial.
METHODS


In total, 216 patients from May 2018 to November 2018 were randomly assigned to the experimental group and the control group at a ratio of 1:1. The experimental group received a periprostatic nerve block combined with subcutaneous perineal anaesthesia and intrarectal lidocaine gel. The control group received total intravenous anaesthesia. A visual analogue scale (VAS) score (0-10) was used to evaluate pain at different stages. The operative time, duration of hospitalisation, intraoperative vital signs, perioperative complications and clinicopathological features were recorded.
RESULTS


The overall detection rate of prostate cancer was 40.74%, and the median Gleason score was 8 for all patients diagnosed with prostate cancer. No significant differences in terms of detection rates, Gleason scores and ISUP/WHO Grade Groups were found between the two groups (P > 0.05). The experimental group had no pain or just met the criteria for mild pain during the biopsy, which was significantly alleviated after the biopsy, and had a shorter operation time compared with that of the control group (P < 0.05). Compared with the control group, the experimental group had more stable haemodynamics and respiratory status and fewer surgical complications (P < 0.05).
CONCLUSIONS


In multiple aspects, a periprostatic nerve block combined with subcutaneous perineal anaesthesia and intrarectal lidocaine gel is a safer and more efficient approach to local anaesthesia for TPBx that can almost replace total intravenous anaesthesia and is worthwhile applying in the clinical setting.",2020,"No significant differences in terms of detection rates, Gleason scores and ISUP/WHO Grade Groups were found between the two groups (P > 0.05).","['216 patients from May 2018 to November 2018', 'transrectal ultrasound guided transperineal prostate biopsy']","['transrectal ultrasound-guided transperineal prostate biopsy (TPBx', 'periprostatic nerve block combined with perineum subcutaneous anaesthesia and intrarectal lidocaine gel', 'subcutaneous perineal anaesthesia and intrarectal lidocaine gel', 'total intravenous anaesthesia', 'periprostatic nerve block combined with perineal subcutaneous anaesthesia and intrarectal lidocaine gel', 'periprostatic nerve block combined with subcutaneous perineal anaesthesia and intrarectal lidocaine gel']","['no pain', 'stable haemodynamics and respiratory status and fewer surgical complications', 'detection rates, Gleason scores and ISUP/WHO Grade Groups', 'A visual analogue scale (VAS) score', 'median Gleason score', 'shorter operation time', 'operative time, duration of hospitalisation, intraoperative vital signs, perioperative complications and clinicopathological features', 'mild pain', 'Efficacy and safety', 'efficacy and safety', 'overall detection rate of prostate cancer']","[{'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205500', 'cui_str': 'Perineal approach (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205500', 'cui_str': 'Perineal approach (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}]","[{'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",216.0,0.0937897,"No significant differences in terms of detection rates, Gleason scores and ISUP/WHO Grade Groups were found between the two groups (P > 0.05).","[{'ForeName': 'Zhengtong', 'Initials': 'Z', 'LastName': 'Lv', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha City, Hunan Province, P.R. China.'}, {'ForeName': 'Huichuan', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha City, Hunan Province, P.R. China.'}, {'ForeName': 'Xiheng', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha City, Hunan Province, P.R. China.'}, {'ForeName': 'Changzhao', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha City, Hunan Province, P.R. China.'}, {'ForeName': 'Harripersaud', 'Initials': 'H', 'LastName': 'Chand', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha City, Hunan Province, P.R. China.'}, {'ForeName': 'Congyi', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha City, Hunan Province, P.R. China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Xiangya Hospital, Central South University, Changsha City, Hunan Province, P.R. China. yuanlixy@csu.edu.cn.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0155-0']
131,32306153,High dietary sodium augments vascular tone and attenuates low-flow mediated constriction in salt-resistant adults.,"INTRODUCTION


Low-flow mediated constriction (L-FMC) has emerged as a valuable and complementary measure of flow-mediated dilation (FMD) for assessing endothelial function non-invasively. High dietary sodium has been shown to impair FMD independent of changes in blood pressure (BP), but its effects on L-FMC are unknown.
PURPOSE


To test the hypothesis that high dietary sodium would attenuate brachial artery L-FMC in salt-resistant adults.
METHODS


Fifteen healthy, normotensive adults (29 ± 6 years) participated in a controlled feeding study. Following a run-in diet, participants completed a 7-day low sodium (LS; 20 mmol sodium/day) and 7-day high sodium (HS; 300 mmol sodium/day) diet in randomized order. On the last day of each diet, 24 h urine was collected and assessments of 24 h ambulatory BP and L-FMC were performed. Salt-resistance was defined as a change in 24 h ambulatory mean arterial pressure (MAP) between the LS and HS diets of ≤ 5 mmHg. Resting vascular tone and L-FMC were calculated from ultrasound-derived arterial diameters.
RESULTS


High dietary sodium increased serum sodium and urinary sodium excretion (p < 0.001 for both), but 24 h MAP was unchanged (p = 0.16) by design. High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008).
CONCLUSION


These findings in salt-resistant adults provide additional evidence that dietary sodium has adverse vascular effects independent of changes in BP.",2020,"High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008).
","['Fifteen healthy, normotensive adults (29\u2009±\u20096\xa0years', 'salt-resistant adults']","['Low-flow mediated constriction (L-FMC', '7-day low sodium (LS; 20\xa0mmol sodium/day) and 7-day high sodium (HS; 300\xa0mmol sodium/day) diet', 'High dietary sodium']","['vascular tone', 'Salt-resistance', 'blood pressure (BP', 'Resting vascular tone and L-FMC', 'ambulatory mean arterial pressure (MAP', 'serum sodium and urinary sodium excretion', 'brachial artery L-FMC']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037570', 'cui_str': 'Dietary Sodium'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009813', 'cui_str': 'Constriction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}]",15.0,0.0307452,"High dietary sodium augmented vascular tone (LS: 91 ± 23%, HS: 125 ± 56%, p = 0.01) and attenuated L-FMC (LS: - 0.58 ± 0.99%, HS: 0.17 ± 1.23%, p = 0.008).
","[{'ForeName': 'Ninette', 'Initials': 'N', 'LastName': 'Shenouda', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Ramick', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA. dge@udel.edu.'}]",European journal of applied physiology,['10.1007/s00421-020-04370-0']
132,31595716,"A prospective clinical trial of the second-look procedure for transoral surgery in patients with T1 and T2 laryngeal, oropharyngeal, and hypopharyngeal cancer.","BACKGROUND


Transoral surgery (TOS) has been widely applied for early T-stage head and neck cancer (HNC). The resection is performed with a minimum safety margin for function preservation under a limited surgical field; therefore, it is difficult to have a strong conviction about the complete resection. This study aims to evaluate the completeness of the initial TOS procedure; possibility of primary control by TOS alone; and predictive factors in patients with early T-stage laryngeal, oropharyngeal, and hypopharyngeal cancer.
METHODS


Patients were treated by TOS at the primary site with or without neck dissection. The patients were divided into two groups based on the pathological evaluation of their surgical specimens: the control (observation) group, in that the resection was considered complete and the intervention (second-look procedure) group, in that incomplete tumor resection was suspected. The predictive factors for the possibility and/or limitations of complete resection by TOS were then analyzed.
RESULTS


The study enrolled 26 and 25 patients in the control and intervention group, respectively. The success rate for single resection was 66% and the predictive factor was tumor depth obtained by enhanced computed tomography (CT) examination (odds ratio, 7.870, P = .0243). The success rate for definitive therapy by TOS alone was 83% and the predictive factor was poor differentiation observed on pathological examination (odds ratio, 6.800, P = .0248).
CONCLUSIONS


TOS has the potential for both definitive resection and function preservation with minimal invasiveness. Identification of the risk factors for TOS is advantageous for accurate treatment selection in patients with early T-stage HNC.",2019,Identification of the risk factors for TOS is advantageous for accurate treatment selection in patients with early T-stage HNC.,"['patients with early T-stage HNC', 'The study enrolled 26 and 25 patients in the control and intervention group, respectively', 'patients with T1 and T2 laryngeal, oropharyngeal, and hypopharyngeal cancer', 'patients with early T-stage laryngeal, oropharyngeal, and hypopharyngeal cancer', 'Patients were treated by TOS at the primary site with or without neck dissection', 'early T-stage head and neck cancer (HNC']","['Transoral surgery (TOS', 'transoral surgery']","['success rate', 'success rate for single resection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0153398', 'cui_str': 'Hypopharyngeal Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}, {'cui': 'C0398395', 'cui_str': 'Neck Dissection'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0442366', 'cui_str': 'Transoral approach (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]",,0.0180819,Identification of the risk factors for TOS is advantageous for accurate treatment selection in patients with early T-stage HNC.,"[{'ForeName': 'Goshi', 'Initials': 'G', 'LastName': 'Nishimura', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sano', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hatano', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Tanabe', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Morishita', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Oridate', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}]",Cancer medicine,['10.1002/cam4.2588']
133,32305259,Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial.,"BACKGROUND


Early pregnancy loss is a common event in the first trimester, occurring in 15%-20% of confirmed pregnancies. A common evidence-based medical regimen for early pregnancy loss uses misoprostol, a prostaglandin E1 analog, with a dosage of 800 μg, self-administered vaginally. The clinical utility of this regimen is limited by suboptimal effectiveness in patients with a closed cervical os, with 29% of patients experiencing early pregnancy loss requiring a second dose after 3 days and 16% of patients eventually requiring a uterine aspiration procedure.
OBJECTIVE


This study aimed to evaluate clinical predictors associated with treatment success in patients receiving medical management with mifepristone-misoprostol or misoprostol alone for early pregnancy loss.
STUDY DESIGN


We performed a planned secondary analysis of a randomized trial comparing mifepristone-misoprostol with misoprostol alone for management of early pregnancy loss. The published prediction model for treatment success of single-dose misoprostol administered vaginally included the following variables: active bleeding, type of early pregnancy loss (anembryonic pregnancy or embryonic and/or fetal demise), parity, gestational age, and treatment site; previous significant predictors were vaginal bleeding within the past 24 hours and parity of 0 or 1 vs >1. To determine if these characteristics predicted differential proportions of patients with treatment success or failure, we performed bivariate analyses; given the small proportion of treatment failures in the combined treatment arm, both arms were combined for analysis. Thereafter, we performed a logistic regression analysis to assess the effect of these predictors collectively in each of the 2 treatment groups separately as well as in the full cohort as a proxy for the combined treatment arm. Finally, by using receiver operating characteristic curves, we tested the ability of these predictors in association with misoprostol treatment success to discriminate between treatment success and treatment failure. To quantify the ability of the score to discriminate between treatment success and treatment failure in each treatment arm as well as in the entire cohort, we calculated the area under the curve. Using multivariable logistic regression, we then assessed our study population for other predictors of treatment success in both treatment groups, with and without mifepristone pretreatment.
RESULTS


Overall, 297 evaluable participants were included in the primary study, with 148 in the mifepristone-misoprostol combined treatment group and 149 in the misoprostol-alone treatment group. Among patients who had vaginal bleeding at the time of treatment, 15 of 17 (88%) in the mifepristone-misoprostol combined treatment group and 12 of 17 (71%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. Among patients with a parity of 0 or 1, 94 of 108 (87%) in the mifepristone-misoprostol treatment group and 66 of 95 (69%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. These clinical characteristics did not predict treatment success in the combined cohort alone (area under the curve=0.56; 95% confidence interval, 0.48-0.64). No other baseline clinical factors predicted treatment success in the misoprostol-alone treatment arm or mifepristone pretreatment arm. In the full cohort, the significant predictors of treatment success were pretreatment with mifepristone (adjusted odds ratio=2.51; 95% confidence interval, 1.43-4.43) and smoking (adjusted odds ratio=2.15; 95% confidence interval, 1.03-4.49).
CONCLUSION


No baseline clinical factors predicted treatment success in women receiving medical management with misoprostol for early pregnancy loss. Adding mifepristone to the medical management regimen of early pregnancy loss improved treatment success; thus, mifepristone treatment should be considered for management of early pregnancy loss regardless of baseline clinical factors.",2020,No other baseline clinical factors predicted treatment success in the misoprostol-alone or mifepristone pretreatment arms individually.,"['alone for early pregnancy loss (EPL', 'women with a closed cervical os, with 29% of women with EPL requiring a second dose after three days, and 16% eventually requiring a uterine aspiration procedure', 'women with a parity of 0 or 1, 94/108 (87%) in the', 'women undergoing medical management of EPL with', 'women receiving medical management with', '297 evaluable subjects in the primary study, including 148 in the', 'combined and 149 in the misoprostol-alone groups', 'women who had vaginal bleeding at the time of treatment, 15/17 (88%) in the']","['prostaglandin E1 analogue misoprostol', 'misoprostol-alone', 'misoprostol-alone or mifepristone', 'mifepristone and misoprostol', 'mifepristone', 'mifepristone-misoprostol or misoprostol', 'mifepristone-misoprostol', 'misoprostol']","['vaginal bleeding', 'pregnancy']","[{'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C1185785', 'cui_str': 'External os structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002335', 'cui_str': 'Alprostadil'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}]","[{'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",,0.312621,No other baseline clinical factors predicted treatment success in the misoprostol-alone or mifepristone pretreatment arms individually.,"[{'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Sonalkar', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA. Electronic address: sarita.sonalkar@pennmedicine.upenn.edu.'}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Koelper', 'Affiliation': ""Department of Obstetrics and Gynecology, Center for Research on Reproduction and Women's Health, Philadelphia, PA.""}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Atrio', 'Affiliation': 'Department of Obstetrics and Gynecology, Montefiore Hospital and Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Department of Biostatistics and Informatics, Center for Integrative Design and Analysis, Colorado School of Public Health, Denver, CO.'}, {'ForeName': 'Arden', 'Initials': 'A', 'LastName': 'McAllister', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, Hospital of the University of Pennsylvania, Philadelphia, PA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.04.006']
134,31462701,"The development and comparative effectiveness of a patient-centered prostate biopsy report: a prospective, randomized study.","PURPOSE


The prostate biopsy pathology report represents a critical document used for decision-making in patients diagnosed with prostate cancer, yet the content exceeds the health literacy of most patients. We sought to create and compare the effectiveness of a patient-centered prostate biopsy report compared with standard reports.
MATERIALS AND METHODS


Using a modified Delphi approach, prostate cancer experts identified critical components of a prostate biopsy report. Patient focus groups provided input for syntax and formatting of patient-centered pathology reports. Ninety-four patients with recent prostate biopsies were block randomized to the standard report with or without the patient-centered report. We evaluated patient activation, self-efficacy, provider communication skills, and prostate cancer knowledge.
RESULTS


Experts selected primary and secondary Gleason score and the number of positive scores as the most important elements of the report. Patients prioritized a narrative design, non-threatening language and information on risk classification. Initial assessments were completed by 87% (40/46) in the standard report group and 81% (39/48) in the patient-centered report group. There were no differences in patient activation, self-efficacy, or provider communication skills between groups. Patients who received the patient-centered report had significantly improved ability to recall their Gleason score (100% vs. 85%, p = 0.026) and number of positive cores (90% vs. 65%, p = 0.014). In total, 86% of patients who received the patient-centered report felt that it helped them better understand their results and should always be provided.
CONCLUSIONS


Patient-centered pathology reports are associated with significantly higher knowledge about a prostate cancer diagnosis. These important health information documents may improve patient-provider communication and help facilitate shared decision-making among patients diagnosed with prostate cancer.",2020,"There were no differences in patient activation, self-efficacy, or provider communication skills between groups.","['patients diagnosed with prostate cancer', 'Ninety-four patients with recent prostate biopsies']",['patient-centered prostate biopsy report'],"['patient activation, self-efficacy, or provider communication skills', 'ability to recall their Gleason score', 'number of positive cores', 'patient activation, self-efficacy, provider communication skills, and prostate cancer knowledge']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",94.0,0.0261744,"There were no differences in patient activation, self-efficacy, or provider communication skills between groups.","[{'ForeName': 'Jasmir G', 'Initials': 'JG', 'LastName': 'Nayak', 'Affiliation': 'Section of Urology, Department of Surgery, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Scalzo', 'Affiliation': 'Department of Urology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Chu', 'Affiliation': 'Department of Urology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Shiff', 'Affiliation': 'Section of Urology, Department of Surgery, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Kearns', 'Affiliation': 'Department of Urology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Geolani W', 'Initials': 'GW', 'LastName': 'Dy', 'Affiliation': 'Department of Urology, New York University, New York, NY, USA.'}, {'ForeName': 'Liam C', 'Initials': 'LC', 'LastName': 'Macleod', 'Affiliation': 'Department of Urology, University of Pittsburgh Medical Center, Hermitage, PA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Mossanen', 'Affiliation': ""Division of Urological Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Ellis', 'Affiliation': 'Department of Urology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Wright', 'Affiliation': 'Department of Urology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'True', 'Affiliation': 'Department of Pathology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Gore', 'Affiliation': 'Department of Urology, University of Washington, Seattle, WA, USA. jnayak@sbgh.mb.ca.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0169-7']
135,31631570,A new risk score for patients after first recurrence of stage 4 neuroblastoma aged ≥18 months at first diagnosis.,"BACKGROUND


The prognosis of patients with recurrences from stage 4 neuroblastoma is not uniformly dismal. The evaluation of new therapies therefore needs to consider the individual risks of the treated patients. This study aims to define clinically useful risk criteria.
PATIENTS AND METHODS


Inclusion criteria were: first recurrence of neuroblastoma stage 4 aged ≥18 months and enrollment in first line trials between 1997 and 2016. Patients were randomized into a training set (N = 310) and an independent validation set (N = 159). The primary endpoint was secondary event-free survival. The individual treatment elements the patients received during initial and recurrent disease were analyzed as binary and time-dependent variables. A five-step multiple time-dependent Cox regression analysis was performed on the training set to identify prognostic variables adjusted for the individual frontline treatment. The selected variables resulted in a prognostic index (PI) and were used to build a risk score system. The score was validated with the validation set.
RESULTS


Of the 469 patients, 372 were treated with curative intent and 97 with palliative intent. The PI included the variables number of recurrence organs (hazard ratio [HR] = 2.27), time to recurrence (HR = 2.03), liver metastasis at diagnosis (HR = 1.77), first recurrence at site of the primary tumor (HR = 1.55), and age (HR = 1.29). Three risk groups were built and confirmed in the validation set. The scoring system was likewise useful for the curatively or palliatively treated subgroups.
CONCLUSION


A new risk score system for patients with first recurrence of stage 4 neuroblastoma aged ≥18 months at diagnosis is proposed.",2019,"The scoring system was likewise useful for the curatively or palliatively treated subgroups.
","['469 patients, 372 were treated with curative intent and 97 with palliative intent', 'patients with first recurrence of stage 4 neuroblastoma aged ≥18\xa0months at diagnosis', 'patients with recurrences from stage 4 neuroblastoma', 'patients after first recurrence of stage 4 neuroblastoma aged ≥18\xa0months at first diagnosis', 'Inclusion criteria were: first recurrence of neuroblastoma stage 4 aged ≥18\xa0months and enrollment in first line trials between 1997 and 2016']",[],"['liver metastasis', 'secondary event-free survival', 'prognostic index (PI', 'time to recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}]",[],"[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",372.0,0.0545839,"The scoring system was likewise useful for the curatively or palliatively treated subgroups.
","[{'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Kreitz', 'Affiliation': 'Institute of Medical Statistics and Clinical Research, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ernst', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Statistics and Clinical Research, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Volland', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hero', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Berthold', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}]",Cancer medicine,['10.1002/cam4.2562']
136,32306033,Twitter promotion predicts citation rates of cardiovascular articles: a preliminary analysis from the ESC Journals Randomized Study.,"AIMS


The association between the dissemination of scientific articles on Twitter and online visibility (including Altmetric score) is still controversial and the impact on citation rates has never been addressed for cardiovascular medicine journals.
METHODS AND RESULTS


The ESC Journals Study randomized 696 papers published in the ESC Journals family (March 2018-May 2019) for promotion on Twitter or to a control arm (with no active tweeting from ESC channels) and aimed to assess if Twitter promotion was associated with an increase in citation rate (primary endpoint) and Altmetric score. This is a preliminary analysis of 536 articles (77% of total) published until December 2018 (therefore, papers published at least 6 months before collecting citation and Altmetrics data). In the analysis of the primary endpoint, Twitter promotion of articles was associated with a 1.43 (95% confidence interval 1.29-1.58) higher rate of citations, and this effect was independent of the type of article. Both Altmetric score and number of users tweeting were positively associated with the number of citations in both arms, with evidence of a stronger association (interaction) in the Twitter arm.
CONCLUSION


Therefore, a social media strategy of Twitter promotion for cardiovascular medicine papers seems to be associated with increased online visibility and higher number of citations. The final analysis will include 696 papers and 2-year scientific citation rate and is estimated to be concluded in March 2021.",2020,"In the analysis of the primary endpoint, Twitter promotion of articles was associated with a 1.43 (95% confidence interval 1.29-1.58) higher rate of citations, and this effect was independent of the type of article.","['696 papers published in the ESC Journals family (March 2018-May 2019) for promotion on Twitter or to a control arm (with no active tweeting from ESC channels', '536 articles (77% of total) published until December 2018 (therefore, papers published at least 6\u2009months before collecting citation and Altmetrics data']",[],"['Altmetric score and number of users tweeting', 'citation rates of cardiovascular articles', 'citation rate (primary endpoint) and Altmetric score']","[{'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",696.0,0.217756,"In the analysis of the primary endpoint, Twitter promotion of articles was associated with a 1.43 (95% confidence interval 1.29-1.58) higher rate of citations, and this effect was independent of the type of article.","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ladeiras-Lopes', 'Affiliation': 'Cardiology Department, Gaia/Espinho Hospital Centre and Cardiovascular Research Centre, Faculty of Medicine, University of Porto, Rua Conceicao Fernandes, 4434-502 Vila Nova de Gaia, Portugal.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Royal Papworth Hospital, Papworth Road, CB2 0AY Cambridge, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Vidal-Perez', 'Affiliation': 'Department of Cardiology, Complejo Hospitalario Universitario de A Coruña, CIBER-CV, University of A Coruña, Lugar Jubias de Arriba 84, 15006 A Coruña, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'European Heart House, Les Templiers 2035 route des colles, CS 80179 Biot, 06903 Sofia-Antipolis Cedex, France.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Lüscher', 'Affiliation': 'Royal Brompton and Harefield Hospitals and Imperial College, Sydney Street, SW3 6NP London, UK.'}]",European heart journal,['10.1093/eurheartj/ehaa211']
137,31946867,Assessing tDCS Placebo Effects on EEG and Cognitive Tasks.,"Divergent thinking (DT) using transcranial direct current stimulation (tDCS) has previously been documented with promising results. This paper examines the placebo effect of tDCS. The reaction from a placebo group was tapped using electroencephalogram (EEG). Their performance was measured as a creativity score and compared to a control group. The experiments included multiplication problems and two DT tasks: Alternative Uses Tasks (AUT) and Instances Task (IT). Neither of the groups were sham stimulated during AUT, but during IT the placebo group was sham stimulated. An automatic noise-detection algorithm was developed to remove the speech-induced EEG noise. Features of power, Welchs power spectral density (WPSD) and Welchs cross PSD (WCPSD)/frequency-band/channel were extracted and fed to the Support Vector Machine (SVM) classifiers. The χ 2 -test showed a significant difference (p<; 0.001) between the no stimulation and sham stimulation conditions when compared to the control group, confirming a placebo effect.",2019,"The χ 2 -test showed a significant difference (p<; 0.001) between the no stimulation and sham stimulation conditions when compared to the control group, confirming a placebo effect.",[],"['placebo', 'Divergent thinking (DT) using transcranial direct current stimulation (tDCS', 'DT tasks: Alternative Uses Tasks (AUT) and Instances Task (IT']","['Features of power, Welchs power spectral density (WPSD) and Welchs', 'EEG and Cognitive Tasks']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]",,0.102644,"The χ 2 -test showed a significant difference (p<; 0.001) between the no stimulation and sham stimulation conditions when compared to the control group, confirming a placebo effect.","[{'ForeName': 'Tine Holmback', 'Initials': 'TH', 'LastName': 'Petersen', 'Affiliation': ''}, {'ForeName': 'Sadasivan', 'Initials': 'S', 'LastName': 'Puthusserypady', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2019.8857549']
138,31944502,4-month moxifloxacin containing regimens in the treatment of patients with sputum-positive pulmonary tuberculosis in South India - a randomised clinical trial.,"BACKGROUND


Shortening tuberculosis (TB) treatment duration is a research priority. We tested the efficacy and safety of 3- and 4-month regimens containing moxifloxacin in a randomised clinical trial in pulmonary TB (PTB) patients in South India.
METHODS


New, sputum-positive, adult, HIV-negative, non-diabetic PTB patients were randomised to 3- or 4-month moxifloxacin regimens [moxifloxacin (M), isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E)] or to a control regimen (2H 3  R 3  Z 3  E 3  /4R 3  H 3  ) [C]. The 4 test regimens were 3R 7  H 7  Z 7  E 7  M 7  [M3], 2R 7  H 7  Z 7  E 7  M 7  /2R 7  H 7  M 7  [M4], 2R 7  H 7  Z 7  E 7  M 7  /2R 3  H 3  M 3  [M4-I] or 2R 7  H 7  Z 7  E 7  M 7  /2R 3  H 3  E 3  M 3  [M4-IE]. Treatment was directly observed. Clinical and bacteriological assessments were done monthly during treatment and for 24 months post-treatment. The primary end point was TB recurrence post-treatment.
RESULTS


Of 1371 patients, randomised, modified intention-to-treat (ITT) analysis was done in 1329 and per-protocol (PP) analysis in 1223 patients. Regimen M3 was terminated due to high TB recurrence rates. 'Favourable' response at end of treatment was 96-100% in the moxifloxacin regimens and 93% in the control  regimen. Among these, the TB recurrence occurred in 4.1% in the M4 regimen and in 4.5% in the control regimen and demonstrated equivalence within a 5% margin (95% CI -3.68, 4.55). Similar findings were observed in modified ITT analysis. The TB recurrence rates in the M4-I and M4-IE regimens did not show equivalence with the control regimen. Sixteen (1.4%) of 1087 patients in the moxifloxacin regimens required treatment modification.
CONCLUSION


The 4-month daily moxifloxacin regimen [M4] was found to be equivalent and as safe as the 6-month thrice-weekly control regimen.",2020,The TB recurrence rates in the M4-I and M4-IE regimens did not show equivalence with the control regimen.,"['1371 patients randomized, modified intention-to-treat (ITT) analysis was done in 1329 and per protocol (PP) analysis in 1223 patients', 'pulmonary TB (PTB) patients in South India', 'patients with sputum positive pulmonary tuberculosis in South India ', 'New, sputum-positive, adult, HIV-negative, non-diabetic PTB patients']","['moxifloxacin', 'moxifloxacin regimens [moxifloxacin (M), isoniazid (H), rifampicin (R), pyrazinamide (Z), ethambutol(E)] or to a control regimen (2H 3  R 3  Z 3  E 3  /4R', '2R 7  H 7  Z 7  E 7  M 7  /2R 3  H 3  M 3  [M4-I] or 2R 7  H 7  Z 7  E 7  M 7  /2R', 'moxifloxacin regimen [M4']","['TB recurrence post-treatment', 'efficacy and safety', 'TB recurrence rates. ', ""Favourable' response"", 'TB recurrence', 'TB recurrence rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0044222', 'cui_str': '1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine'}, {'cui': 'C1173706', 'cui_str': ""7-methoxy-6-(2'-methoxy-3'-hydroxy-3'-methyl butyl)""}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1371.0,0.0858817,The TB recurrence rates in the M4-I and M4-IE regimens did not show equivalence with the control regimen.,"[{'ForeName': 'Banurekha', 'Initials': 'B', 'LastName': 'Velayutham', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Mohideen Shaheed', 'Initials': 'MS', 'LastName': 'Jawahar', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Nair', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Pooranagangadevi', 'Initials': 'P', 'LastName': 'Navaneethapandian', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Chinnaiyan', 'Initials': 'C', 'LastName': 'Ponnuraja', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Kandasamy', 'Initials': 'K', 'LastName': 'Chandrasekaran', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Gomathi', 'Initials': 'G', 'LastName': 'Narayan Sivaramakrishnan', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Marimuthu', 'Initials': 'M', 'LastName': 'Makesh Kumar', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Paramasivam', 'Initials': 'P', 'LastName': 'Paul Kumaran', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Santhanakrishnan', 'Initials': 'S', 'LastName': 'Ramesh Kumar', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Dhanaraj', 'Initials': 'D', 'LastName': 'Baskaran', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bella Devaleenal', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Devarajulu Reddy', 'Initials': 'DR', 'LastName': 'Sirasanambati', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Vellore, India.'}, {'ForeName': 'Mahalingam', 'Initials': 'M', 'LastName': 'Vasantha', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Paramasivam', 'Initials': 'P', 'LastName': 'Palaniyandi', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Ramachandran', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Kadayam Ranganathan', 'Initials': 'KR', 'LastName': 'Uma Devi', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Elizabeth Hannah', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Gomathi', 'Initials': 'G', 'LastName': 'Sekar', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Ammayappan', 'Initials': 'A', 'LastName': 'Radhakrishnan', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Dharuman', 'Initials': 'D', 'LastName': 'Kalaiselvi', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Angamuthu', 'Initials': 'A', 'LastName': 'Dhanalakshmi', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Elangovan', 'Initials': 'E', 'LastName': 'Thiruvalluvan', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Murugesan', 'Initials': 'M', 'LastName': 'Raja Sakthivel', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Madurai, India.'}, {'ForeName': 'Ayyamperumal', 'Initials': 'A', 'LastName': 'Mahilmaran', 'Affiliation': 'Institute of Thoracic Medicine, Chennai, India.'}, {'ForeName': 'Rathinam', 'Initials': 'R', 'LastName': 'Sridhar', 'Affiliation': 'Government Hospital for Thoracic Medicine, Chennai, India.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Jayabal', 'Affiliation': 'Revised National TB Control Programme, Chennai, India.'}, {'ForeName': 'Prabhakaran', 'Initials': 'P', 'LastName': 'Rathinam', 'Affiliation': 'Government Rajaji Hospital, Madurai, India.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Angamuthu', 'Affiliation': 'Government Vellore Medical College Hospital, Vellore, India.'}, {'ForeName': 'Kumaresan', 'Initials': 'K', 'LastName': 'Soorappa Ponnusamy', 'Affiliation': 'Government Vellore Medical College Hospital, Vellore, India.'}, {'ForeName': 'Perumal', 'Initials': 'P', 'LastName': 'Venkatesan', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Natrajan', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Prasad Tripathy', 'Affiliation': 'ICMR- National Institute for Research in Tuberculosis, Chennai, India.'}, {'ForeName': 'Soumya', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'World Health Organization, Geneva, Switzerland.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13371']
139,31946903,Photoplethysmography Response to Laryngeal Mask Airway Insertion during Propofol-Remifentanil Anethesia.,"The present study was aimed to evaluate the abilities of photoplethysmography (PPG)-derived parameters, including sample entropy of PPG (SampEn), amplitude of PPG (PPGA), pulse beat interval (PBI) and diastolic interval (DI) extracted by nonlinear or linear methods, to monitor the balance between nociception and antinociception. 26 ASA I or II patients were randomized into one of the three groups to receive a remifentanil effect-compartment target controlled infusion (Ce remi ) of 1, 3 and 5 ng/ml and an effect-compartment target controlled propofol infusion (Ce prop ) to keep the state entropy (SE) at 50 (40~60). Laryngeal mask airway (LMA) insertion was applied as a noxious stimulus. The percentage of change in SampEn (△SampEn, AUC=0.896), PBI (△PBI, AUC=0.896) and DI (ΔDI, AUC=0.972), but not in PPGA (△PPGA, AUC=0.667), were statistically excellent in discriminating low Ce remi  (1 ng/ml) from higher Ce remi  (3 and 5 ng/ml). Additionally, the prediction probabilities (P k ) values of △SampEn, ΔPBI and ΔDI were high as well with 0.795, 0.754 and 0.813 for discriminating Ce remi . These results demonstrated that nonlinear and linear parameters of SampEn, PBI and DI had strong dependency on Ce remi  in response to LMA insertion and could provide nociceptive information during propofol-remifentanil anesthesia. This indicated that PPG-derived parameters were potential to develop the clinical assessment of nociception-antinociception balance under general anesthesia.",2019,"The percentage of change in SampEn (△SampEn, AUC=0.896), PBI (△PBI, AUC=0.896) and DI (ΔDI, AUC=0.972), but not in PPGA (△PPGA, AUC=0.667), were statistically excellent in discriminating low Ce remi  (1 ng/ml) from higher Ce remi  (3 and 5 ng/ml).",['26'],"['remifentanil effect-compartment target controlled infusion (Ce remi ) of 1, 3 and 5 ng/ml and an effect-compartment target controlled propofol infusion (Ce prop ) to keep the state entropy (SE', 'Propofol-Remifentanil Anethesia', 'Laryngeal mask airway (LMA) insertion']","['Photoplethysmography Response', 'prediction probabilities (P k ) values of △SampEn, ΔPBI and ΔDI', 'abilities of photoplethysmography (PPG)-derived parameters, including sample entropy of PPG (SampEn), amplitude of PPG (PPGA), pulse beat interval (PBI) and diastolic interval (DI', 'percentage of change in SampEn']",[],"[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0396618', 'cui_str': 'Laryngeal mask airway insertion (procedure)'}]","[{'cui': 'C0162599', 'cui_str': 'Light Reflection Rheography'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",26.0,0.0473909,"The percentage of change in SampEn (△SampEn, AUC=0.896), PBI (△PBI, AUC=0.896) and DI (ΔDI, AUC=0.972), but not in PPGA (△PPGA, AUC=0.667), were statistically excellent in discriminating low Ce remi  (1 ng/ml) from higher Ce remi  (3 and 5 ng/ml).","[{'ForeName': 'Wanlin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Xinzhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': ''}, {'ForeName': 'Cuicui', 'Initials': 'C', 'LastName': 'Jiao', 'Affiliation': ''}, {'ForeName': 'Shali', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2019.8857907']
140,31955480,Can combined online and face-to-face continuing medical education improve the clinical knowledge and skills of family doctors in Vietnam? A cluster randomised controlled trial.,"OBJECTIVES


To assess the effectiveness of a combined online and face-to-face continuing medical education (CME) programme, for improvement in clinical knowledge and skills of family doctors, in comparison with a control group; and to explore the self-reported satisfaction, competencies and confidence of those in the intervention group.
METHODS


We used a cluster randomised controlled trial, with pre- and post-testing, and a feedback survey at the end of the 18-month CME programme. The measurements consisted of a multiple-choice test, an objective structured clinical examination test and an anonymously self-administered questionnaire.
RESULTS


There were 58 family doctors from four provinces in the intervention group and 32 doctors from three provinces in control group, both in the Mekong Delta region in Vietnam. The mean age of participants was 47.8 years, and the female/male ratio was 1/2.9. After training, the intervention group had significantly higher scores on overall knowledge (mean difference = 1.4, 95% CI 1.0-1.86, P < 0.001; Cohen's d 1.36, Pearson's r 0.53), in four of the five education modules: peptic disorders, diabetes, hypertension and bone-muscle-joint diseases (Pearson's r 0.56, 0.56, 0.34 and 0.4, respectively), and in problem-solving skills (Pearson's r 0.27). Self-reports showed a positive learning attitude, strong interest and improved confidence and competency among doctors in the intervention group.
CONCLUSIONS


A combined online and face-to-face CME programme proved applicable and effective for improving the clinical knowledge and problem-solving skills of family doctors in Vietnam.",2020,"Self-reports showed a positive learning attitude, strong interest, and improved confidence and competency among doctors in the intervention group.
","['The mean age of participants was 47.8 years, and the female/male ratio was 1/2.9', '58 family doctors from 4 provinces in the intervention group and 32 doctors from 3 provinces in control group, both in the Mekong Delta region in Vietnam']",['combined online and face-to-face continuing medical education (CME) program'],"['overall knowledge', 'peptic disorders, diabetes, hypertension, and bone-muscle-joint diseases']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1704221', 'cui_str': 'Physicians, Family'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0013632', 'cui_str': 'Education, Medical, Continuing'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0443277', 'cui_str': 'Peptic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}]",,0.0643247,"Self-reports showed a positive learning attitude, strong interest, and improved confidence and competency among doctors in the intervention group.
","[{'ForeName': 'Thuy T N', 'Initials': 'TTN', 'LastName': 'Thai', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Can Tho University of Medicine and Pharmacy, Can Tho, Vietnam.'}, {'ForeName': 'Kien T', 'Initials': 'KT', 'LastName': 'Nguyen', 'Affiliation': 'Faculty of Medicine, Can Tho University of Medicine and Pharmacy, Can Tho, Vietnam.'}, {'ForeName': 'Tam T', 'Initials': 'TT', 'LastName': 'Pham', 'Affiliation': 'Faculty of Public Health, Can Tho University of Medicine and Pharmacy, Can Tho, Vietnam.'}, {'ForeName': 'Phuong M', 'Initials': 'PM', 'LastName': 'Nguyen', 'Affiliation': 'Faculty of Medicine, Can Tho University of Medicine and Pharmacy, Can Tho, Vietnam.'}, {'ForeName': 'Anselme', 'Initials': 'A', 'LastName': 'Derese', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13372']
141,32306213,Changes in Sexual Behaviors in Men Who Have Sex with Men: A Comparison Between the Double-Blind and Open-Label Extension Phases of the ANRS-IPERGAY Trial.,"Pre-Exposure Prophylaxis (PrEP) is changing the landscape of HIV prevention, and may bring changes in sexual behaviors. The double-blind phase (DBP) and open-label extension (OLE) study of the ANRS-IPERGAY trial allowed us to assess changes in sexual behavior of men who have sex with men (MSM) taking sexual activity-based (i.e., on-demand) PrEP. Generalized Estimating Equation (GEE) models found a significant decrease in the number of sexual partners (Coefficient [CI95%], p value; - 0.37[- 0.70 to - 0.04], p = 0.03) between the DBP and OLE as well as in the number of sexual relations (- 0.25 [- 0.49 to 0.00], 0.04). GEE estimates also showed that respondents' most recent sexual relation was less likely to have been with an unknown casual partner during the OLE than during the DBP (Odds Ratio [CI95%], p value: 0.75[0.62-0.92], 0.005). Furthermore, they showed an increase in the proportion of condomless anal sex in the OLE (1.32[1.04-1.67], 0.02), a decrease in the proportion of 'suboptimal PrEP adherence' over time (0.75[0.58-0.97], p = 0.03), a decrease in PrEP only use (0.73[0.55-0.96], 0.03) and in both PrEP and condom use over time (0.70[0.51-0.95], 0.02) and finally, a decrease in alcohol consumption between the DBP and OLE (0.74[0.61-0.90], 0.002). We observed both protective and risky behaviors in terms of HIV and STI risk after on-demand PrEP uptake in the OLE phase. Our findings are consistent with results from previous PrEP trials.",2020,We observed both protective and risky behaviors in terms of HIV and STI risk after on-demand PrEP uptake in the OLE phase.,"['Who Have Sex with Men', 'men who have sex with men (MSM) taking sexual activity-based (i.e., on-demand) PrEP', 'Men']","['double-blind phase (DBP) and open-label extension (OLE', 'Pre-Exposure Prophylaxis (PrEP']","['alcohol consumption', 'Sexual Behaviors', 'number of sexual relations', 'protective and risky behaviors', 'number of sexual partners', ""proportion of 'suboptimal PrEP adherence"", 'proportion of condomless anal sex']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0556463', 'cui_str': 'Number of sexual partners'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}]",,0.0486494,We observed both protective and risky behaviors in terms of HIV and STI risk after on-demand PrEP uptake in the OLE phase.,"[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Di Ciaccio', 'Affiliation': ""Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Marseille, France. marion.di-ciaccio@inserm.fr.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Sagaon-Teyssier', 'Affiliation': ""Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Marseille, France.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mimi', 'Affiliation': ""Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Marseille, France.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Suzan-Monti', 'Affiliation': ""Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Marseille, France.""}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Protiere', 'Affiliation': ""Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Marseille, France.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rojas Castro', 'Affiliation': ""Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Marseille, France.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'INSERM SC 10 US 19, Villejuif, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tremblay', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal- Hôtel Dieu, Montréal, Canada.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Chidiac', 'Affiliation': 'Département Des Maladies Infectieuses, Hôpital de la Croix Rousse, Centre Hospitalier et Universitaire de Lyon, Lyon, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Capitant', 'Affiliation': 'Département des maladies infectieuses, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Université de Paris Diderot Paris 7, INSERM U941, Paris, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Préau', 'Affiliation': ""Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Marseille, France.""}, {'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Département des maladies infectieuses, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Université de Paris Diderot Paris 7, INSERM U941, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Spire', 'Affiliation': ""Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de L'Information Médicale, Marseille, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AIDS and behavior,['10.1007/s10461-020-02864-8']
142,32306462,"Reduction in Migraine and Headache Frequency and Intensity With Combined Antioxidant Prophylaxis (N-acetylcysteine, Vitamin E, and Vitamin C): A Randomized Sham-Controlled Pilot Study.","OBJECTIVE


To investigate the preventive effects of a combined antioxidant drug (N-acetylcysteine, vitamin E, and vitamin C [NEC]) on migraine outcomes. Migraine is characterized by increased oxidative stress and neurogenic inflammation in the brain; therefore, antioxidants may have a migraine preventive effect.
DESIGN


Randomized, double-blind, sham-controlled pilot study.
SETTING


Australian community.
SUBJECTS


Adults reporting 2 to 8 migraines per month for at least a year.
METHODS


After a 1-month baseline period, 35 subjects completed 3 months of treatment with NEC (n = 19) or sham (n = 16) capsules. The primary outcome was the difference in mean number of headaches per month between baseline and final month of the trial for NEC and sham groups; secondary outcomes are listed below.
RESULTS


For NEC there was a significant decrease in mean number of headaches by 3.0 per month (P = 0.004) compared with 1.4 for sham (P = 0.073); there was no significant difference in these changes between the 2 groups (P = 0.052). Average monthly headache (P = 0.041) and migraine frequency (P = 0.018) were significantly less for NEC vs. sham. In NEC subjects, there was a significant decrease in average monthly migraine days (-3.1), moderate/severe headache days (-3.2), migraine duration, headache pain scores, and acute headache medication use.
CONCLUSIONS


This is the first randomized controlled trial to find that combined antioxidant therapy with NEC reduces headaches and migraines in adult migraineurs. Given the limitations of this pilot study, an adequately powered randomized controlled trial is planned to further investigate antioxidant prophylaxis in migraine.",2020,Average monthly headache (p = .041) and migraine frequency (p = .018) were significantly less for NEC versus sham.,"['Australian community', 'adult migraineurs', 'Adults reporting 2-8 migraines per month for at least a year']","['combined antioxidant drug known as NEC (N-acetylcysteine, Vitamin E and C', 'NEC', 'Combined Antioxidant Prophylaxis (N-acetylcysteine, Vitamin E and Vitamin C: NEC']","['migraine frequency', 'average monthly migraine days (-3.1), moderate/severe headache days (-3.2), migraine duration, headache pain scores and acute headache medication use', 'migraine outcomes', 'headaches and migraines', 'Average monthly headache', 'mean number of headaches']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0206695', 'cui_str': 'Neuroendocrine carcinoma'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",35.0,0.324419,Average monthly headache (p = .041) and migraine frequency (p = .018) were significantly less for NEC versus sham.,"[{'ForeName': 'Eric John', 'Initials': 'EJ', 'LastName': 'Visser', 'Affiliation': 'School of Medicine, University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Drummond', 'Affiliation': 'Murdoch University, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Julia L A', 'Initials': 'JLA', 'LastName': 'Lee-Visser', 'Affiliation': 'School of Medicine, University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12902']
143,31514201,The effect of methylphenidate on social cognition and oxytocin in children with attention deficit hyperactivity disorder.,"The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide which regulates social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Utilizing a double-blind placebo-controlled design, we compared the performance of 50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction. Children with ADHD displayed significantly poorer ToM performance; however, following MPH administration, their performance normalized and differences between children with ADHD and HC were no longer found. Salivary OT levels at baseline did not differ between children with ADHD and HCs. However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD. Administration of MPH attenuated this difference such that after parent-child interaction differences in OT levels between children with ADHD and HC were no longer found. In the ADHD group, OT levels decreased from administration of placebo to the parent-child interaction. However, the administration of MPH to children with ADHD was associated with an increase in OT levels after the parent-child interaction. We conclude that OT might play a role as a mediator of social deficits in children with ADHD and that the reactivity of the OT system to social interaction in children with ADHD might be impaired. Stimulants may improve ToM and social functions in children with ADHD via its impact on the OT system. PRS: OT and Social Cognition in Children with ADHD: Impact of MPH.",2020,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","['Children with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', '50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks', 'children with ADHD at baseline and following an interpersonal interaction', 'children with attention deficit hyperactivity disorder', 'children with ADHD']","['methylphenidate', 'HC', 'MPH', 'MPH/placebo', 'oxytocin (OT', 'placebo', 'methylphenidate (MPH']","['ToM and social functions', 'poorer ToM performance', 'Salivary OT levels', 'social cognition and oxytocin', 'ToM and salivary OT levels', 'OT levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",50.0,0.04804,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Levi-Shachar', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila Z', 'Initials': 'HZ', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Goldwin', 'Affiliation': 'Shalvata Mental Health Center, Hod-Hasharon, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'Department of Psychology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. hagaima@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0522-5']
144,31473065,Cluster Randomized Trial for Hypertension Control: Effect on Lifestyles and Body Weight.,"INTRODUCTION


Lifestyle modification, such as healthy diet habits, regular physical activity, and maintaining a normal body weight, must be prescribed to all hypertensive individuals. This study aims to test whether a multicomponent intervention is effective in improving lifestyle and body weight among low-income families.
STUDY DESIGN


Cluster randomized trial conducted between June 2013 and October 2016.
SETTING/PARTICIPANTS


A total of 1,954 uninsured adult patients were recruited in the study within 18 public primary healthcare centers of Argentina.
INTERVENTION


Components targeting the healthcare system, providers, and family groups were delivered by community health workers; tailored text messages were sent for 18 months.
MAIN OUTCOME MEASURES


Changes in the proportion of behavioral risk factors and body weight from baseline to end of follow-up. Data were analyzed in 2017.
RESULTS


Low fruit and vegetable consumption (fewer than 5 servings per day) decreased from 96.4% at baseline to 92.6% at 18 months in the intervention group, whereas in the control group it increased from 97.0% to 99.9% (p=0.0110). The proportion of low physical activity (<600 MET-minutes/week) decreased from 54.3% at baseline to 46.2% at 18 months in the intervention group and kept constant around 52% (p=0.0232) in the control group. The intervention had no effect on alcohol intake (p=0.7807), smoking (p=0.7607), addition of salt while cooking or at the table (p=0.7273), or body weight (p=0.4000).
CONCLUSIONS


The multicomponent intervention was effective for increasing fruit and vegetable intake and physical activity with no effect on alcohol consumption, smoking, addition of salt, or body weight among low-income families in Argentina.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT01834131.",2019,"The multicomponent intervention was effective for increasing fruit and vegetable intake and physical activity with no effect on alcohol consumption, smoking, addition of salt, or body weight among low-income families in Argentina.
","['Cluster randomized trial conducted between June 2013 and October 2016', 'A total of 1,954 uninsured adult patients were recruited in the study within 18 public primary healthcare centers of Argentina', 'low-income families in Argentina']","['Components targeting the healthcare system, providers, and family groups were delivered by community health workers; tailored text messages', 'multicomponent intervention']","['lifestyle and body weight', 'proportion of behavioral risk factors and body weight', 'proportion of low physical activity', 'alcohol intake (p=0.7807), smoking (p=0.7607), addition of salt while cooking or at the table (p=0.7273), or body weight (p=0.4000', 'alcohol consumption, smoking, addition of salt, or body weight', 'Low fruit and vegetable consumption']","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",18.0,0.0570637,"The multicomponent intervention was effective for increasing fruit and vegetable intake and physical activity with no effect on alcohol consumption, smoking, addition of salt, or body weight among low-income families in Argentina.
","[{'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Poggio', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina. Electronic address: rpoggio@iecs.org.ar.'}, {'ForeName': 'Santiago E', 'Initials': 'SE', 'LastName': 'Melendi', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Beratarrechea', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Luz', 'Initials': 'L', 'LastName': 'Gibbons', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Mills', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana; Tulane University Translational Science Institute, New Orleans, Louisiana.'}, {'ForeName': 'Chung-Shiuan', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana; Tulane University Translational Science Institute, New Orleans, Louisiana.'}, {'ForeName': 'Analía', 'Initials': 'A', 'LastName': 'Nejamis', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Gulayin', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Marilina', 'Initials': 'M', 'LastName': 'Santero', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana; Tulane University Translational Science Institute, New Orleans, Louisiana; Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Rubinstein', 'Affiliation': 'National Ministry of Health, Buenos Aires, Argentina.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana; Tulane University Translational Science Institute, New Orleans, Louisiana; Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Irazola', 'Affiliation': 'Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.05.011']
145,31486777,Magnetic seizure therapy (MST) for major depressive disorder.,"Electroconvulsive therapy (ECT) is effective for major depressive disorder (MDD) but its effects on memory limit its widespread use. Magnetic seizure therapy (MST) is a potential alternative to ECT that may not adversely affect memory. In the current trial, consecutive patients with MDD consented to receive MST applied over the prefrontal cortex according to an open-label protocol. Depressive symptoms and cognition were assessed prior to, during and at the end of treatment. Patients were treated two to three times per week with high-frequency MST (i.e., 100 Hz) (N = 24), medium frequency MST (i.e., 60 or 50 Hz) (N = 26), or low-frequency MST (i.e., 25 Hz MST) (N = 36) using 100% stimulator output. One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n = 17) or received a maximum of 24 sessions (n = 30). High-frequency (100 Hz) MST produced the highest remission rate (33.3%). Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance. Under open conditions, MST led to clinically meaningful reduction in depressive symptoms in patients with MDD and produced minimal cognitive impairment. Future studies should compare MST and ECT under double-blind randomized condition.",2020,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","['consecutive patients with MDD consented to receive', 'major depressive disorder', 'One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n\u2009=\u200917) or received a maximum of 24 sessions (n\u2009=\u200930']","['Magnetic seizure therapy (MST', 'Electroconvulsive therapy (ECT', 'MST']","['depressive symptoms', 'High-frequency', 'Depressive symptoms and cognition', 'minimal cognitive impairment', 'highest remission rate', 'brief visuospatial memory task performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1291708', 'cui_str': 'Minimal cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",140.0,0.0334955,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Neurocognitive Research Laboratory, Department of Psychiatry, University of Texas Southwestern Medical Center, and Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldbloom', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Toronto General Hospital, University Health Network, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Commercial Rd Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0515-4']
146,31977817,"A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures.","BACKGROUND


Romosozumab is a bone-forming antibody that increases bone formation and decreases bone resorption. We conducted a double-blinded, randomized, phase-2, dose-finding trial to evaluate the effect of romosozumab on the clinical outcomes of open reduction and internal fixation of intertrochanteric or femoral neck hip fractures.
METHODS


Patients (55 to 94 years old) were randomized 2:3:3:3 to receive 3 subcutaneous injections of romosozumab (70, 140, or 210 mg) or a placebo postoperatively on day 1 and weeks 2, 6, and 12. The primary end point was the difference in the mean timed ""Up & Go"" (TUG) score over weeks 6 to 20 for romosozumab versus placebo. Additional end points included the time to radiographic evidence of healing and the score on the Radiographic Union Scale for Hip (RUSH).
RESULTS


A total of 332 patients were randomized: 243 to receive romosozumab (70 mg, n = 60; 140 mg, n = 93; and 210 mg, n = 90) and 89 to receive a placebo. Although TUG scores improved during the study, they did not differ significantly between the romosozumab and placebo groups over weeks 6 to 20 (p = 0.198). The median time to radiographic evidence of healing was 16.4 to 16.9 weeks across treatment groups. The RUSH scores improved over time across treatment groups but did not differ significantly between the romosozumab and placebo groups. The overall safety and tolerability profile of romosozumab was comparable with that of the placebo.
CONCLUSIONS


Romosozumab did not improve the fracture-healing-related clinical and radiographic outcomes in the study population.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Although TUG scores improved during the study, they did not differ significantly between the romosozumab and placebo groups over weeks 6 to 20 (p = 0.198).","['332 patients were randomized: 243 to receive', 'Hip Fractures', 'Patients (55 to 94 years old']","['Placebo', 'placebo', 'romosozumab', 'Romosozumab']","['median time to radiographic evidence of healing', 'fracture-healing-related clinical and radiographic outcomes', 'RUSH scores', 'time to radiographic evidence of healing and the score on the Radiographic Union Scale for Hip (RUSH', 'overall safety and tolerability profile of romosozumab', 'mean timed ""Up & Go"" (TUG) score', 'bone formation and decreases bone resorption', 'TUG scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3661283'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0443052', 'cui_str': 'Rush (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3661283'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}]",332.0,0.343383,"Although TUG scores improved during the study, they did not differ significantly between the romosozumab and placebo groups over weeks 6 to 20 (p = 0.198).","[{'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': 'Department of Surgery, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Miclau', 'Affiliation': 'Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Theofilos', 'Initials': 'T', 'LastName': 'Karachalios', 'Affiliation': 'Orthopaedic Department UGHL, School of Health Sciences, University of Thessalia, Larissa, Greece.'}, {'ForeName': 'Lauren L', 'Initials': 'LL', 'LastName': 'Nowak', 'Affiliation': 'Department of Surgery, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Sancheti', 'Affiliation': 'Sancheti Institute of Orthopaedics and Rehabilitation, Pune, India.'}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Caminis', 'Affiliation': 'Sanofi Genzyme, Bridgewater, New Jersey.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Ricardo E', 'Initials': 'RE', 'LastName': 'Dent-Acosta', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Ogo', 'Initials': 'O', 'LastName': 'Egbuna', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Maddox', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00790']
147,31634898,A multipredictor model to predict the conversion of mild cognitive impairment to Alzheimer's disease by using a predictive nomogram.,"Predicting the probability of converting from mild cognitive impairment (MCI) to Alzheimer's disease (AD) is still a challenging task. This study aims at providing a personalized MCI-to-AD conversion estimation by using a multipredictor nomogram that integrates neuroimaging features, cerebrospinal fluid (CSF) biomarker, and clinical assessments. To do so, 290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI. All subjects were randomly divided into a primary and validation cohort. Radiomics signature (Rad-sig) was obtained based on 17 cerebral cortex features selected by using Least Absolute Shrinkage and Selection Operator (LASSO) algorithm. Clinical factors and amyloid-beta peptide (Aβ) concentration were selected by using Spearman correlation between the converted and not-converted patients. Then, a nomogram that combines image features, clinical factor, and Aβ concentration was constructed and validated. Furthermore, we explored the associations between various predictors from the macro- to the microperspective by assessing gene expression patterns. Our results showed that the multipredictor nomogram (C-index 0.978 and 0.956 in both cohorts, respectively) outperformed the nomogram using either Rad-sig or Aβ concentration as individual predictors. Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways. Our study may have a clinical impact as a powerful predictive tool for predicting the conversion probability of MCI and providing associations between cognitive impairment, structural changes, Aβ levels, and underlying biological patterns from the macro- to the microperspective.",2020,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[""290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI""]",[],"['neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways', 'Clinical factors and amyloid-beta peptide (Aβ) concentration']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0078939', 'cui_str': ""Alzheimer's ABP""}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0173736,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[{'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Liaojun', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Sciences and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China. huangly@mail.xidian.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0551-0']
148,31590179,Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial.,"Glutamate and opioid systems play important roles in alcohol drinking behaviors. We examined if combined treatment with the NMDA antagonist memantine and the opioid antagonist naltrexone, when compared with naltrexone alone, would have a greater influence on alcohol drinking behaviors. Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism, participated in a randomized, double-blind, crossover trial, including two 6-8 days treatment periods, separated by a 6-day washout, and 3 alcohol drinking paradigm (ADP) sessions. After the first baseline (BAS) ADP1 session, participants were randomized to receive either naltrexone (NTX; 50 mg/day) + placebo memantine, or NTX (50 mg/day) + memantine (MEM; 20 mg/day), during the first treatment period, following which they completed ADP2. After a 6-day washout, participants were crossed over to the treatment they did not receive during the first treatment period, following which they completed ADP3. During each ADP, participants received a priming drink of alcohol followed by 3 1-hour, self-administration periods during which they had ad-lib access to 12 drinks. Individually, both NTX and NTX + MEM, when compared to BAS ADP1, significantly reduced the number of drinks consumed (p's < 0.001) and craving (p's < 0.001). When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004). Specifically, when NTX + MEM followed NTX alone, NTX + MEM resulted in a further reduction in drinking (mean: -1.94; 95% CI: -2.6, -0.8, p = 0.0005). However, when NTX alone followed NTX + MEM, NTX alone did not lead to further reduction in drinking (mean: 0.59; 95% CI: -0.67, 1.43, p = 0.47). Similar patterns were observed for alcohol craving; specifically, a significant reduction in craving was observed when NTX + MEM followed NTX alone (p = 0.009), but craving reduction was maintained when NTX + MEM was followed by NTX alone. Neither treatment condition significantly influenced alcohol-induced stimulation or sedation. Memantine (at a dose of 20 mg/day) enhances the efficacy of naltrexone (50 mg/day) in reducing alcohol drinking and craving among FHP drinkers with beneficial effects that appear to carryover after discontinuation of memantine treatment.",2020,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","['Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism']","['Memantine', 'naltrexone', 'NTX\u2009+\u2009MEM vs. NTX', 'NMDA antagonist memantine', 'NTX', 'alcohol drinking paradigm (ADP) sessions', 'naltrexone (NTX; 50\u2009mg/day)\u2009+\u2009placebo memantine, or NTX (50\u2009mg/day)\u2009+\u2009memantine (MEM', 'opioid antagonist naltrexone', 'naltrexone and memantine', 'priming drink of alcohol']","['craving', 'alcohol craving', 'alcohol drinking behaviors', 'craving reduction', 'number of drinks consumed', 'alcohol drinking and craving', 'alcohol-induced stimulation or sedation']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0565662', 'cui_str': 'Finding relating to alcohol drinking behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",12.0,0.0285429,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA. suchitra.krishnan-sarin@yale.edu.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0536-z']
149,31427334,"SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial.","INTRODUCTION


In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM.
METHODS


The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle.
ETHICS AND DISSEMINATION


The study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NTR6134; Pre-results.",2019,The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile).,"['women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment', 'women who do not reach target glycaemic control with combined', 'Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation']","['metformin, glibenclamide and insulin', 'conventional insulin-based therapy for GDM', 'Monotherapy with metformin or glibenclamide (glyburide', 'glibenclamide, or randomised to treatment with insulin', 'OGLDs, starting with metformin', 'metformin and glibenclamide, glibenclamide']","['incidence of large-for-gestational-age infants (birth weight >90th percentile', 'clinical effectiveness, cost-effectiveness', 'maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0560523', 'cui_str': 'Does not reach (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0017628', 'cui_str': 'glibenclamide'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1848395', 'cui_str': 'Large for gestational age'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0564778', 'cui_str': 'Obstetric complication NOS'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}]",,0.222245,The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile).,"[{'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'de Wit', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Doortje', 'Initials': 'D', 'LastName': 'Rademaker', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Daphne N', 'Initials': 'DN', 'LastName': 'Voormolen', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Bettina M C', 'Initials': 'BMC', 'LastName': 'Akerboom', 'Affiliation': 'Department of Obstetrics and Gynaecology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Rosalie M', 'Initials': 'RM', 'LastName': 'Kiewiet-Kemper', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Maarten R', 'Initials': 'MR', 'LastName': 'Soeters', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marion A L', 'Initials': 'MAL', 'LastName': 'Verwij-Didden', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bernhoven Hospital, Uden, The Netherlands.'}, {'ForeName': 'Fahima', 'Initials': 'F', 'LastName': 'Assouiki', 'Affiliation': 'Department of Internal Medicine, Bernhoven Hospital, Uden, The Netherlands.'}, {'ForeName': 'Daniela H', 'Initials': 'DH', 'LastName': 'Schippers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Mechteld A R', 'Initials': 'MAR', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Internal Medicine, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Simone M I', 'Initials': 'SMI', 'LastName': 'Kuppens', 'Affiliation': 'Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Mirjam M', 'Initials': 'MM', 'LastName': 'Oosterwerff', 'Affiliation': 'Department of Internal Medicine, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Joost J', 'Initials': 'JJ', 'LastName': 'Zwart', 'Affiliation': 'Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Mattheus J M', 'Initials': 'MJM', 'LastName': 'Diekman', 'Affiliation': 'Department of Internal Medicine, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Tatjana E', 'Initials': 'TE', 'LastName': 'Vogelvang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Diakonessenhuis Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'P Rob J', 'Initials': 'PRJ', 'LastName': 'Gallas', 'Affiliation': 'Department of Internal Medicine, Diakonessenhuis Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Galjaard', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Visser', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Horree', 'Affiliation': 'Department of Obstetrics and Gynaecology, Flevoziekenhuis, Almere, The Netherlands.'}, {'ForeName': 'Tamira K', 'Initials': 'TK', 'LastName': 'Klooker', 'Affiliation': 'Department of Internal Medicine, Flevoziekenhuis, Almere, The Netherlands.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Laan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelderse Vallei Hospital, Ede, The Netherlands.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Heijligenberg', 'Affiliation': 'Department of Internal Medicine, Gelderse Vallei Hospital, Ede, The Netherlands.'}, {'ForeName': 'Anjoke J M', 'Initials': 'AJM', 'LastName': 'Huisjes', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelre Hospitals, Apeldoorn, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'van Bemmel', 'Affiliation': 'Department of Internal Medicine, Gelre Hospitals, Apeldoorn, The Netherlands.'}, {'ForeName': 'Claudia A', 'Initials': 'CA', 'LastName': 'van Meir', 'Affiliation': 'Department of Obstetrics and Gynaecology, Groene Hart Hospital, Gouda, The Netherlands.'}, {'ForeName': 'Annewieke W', 'Initials': 'AW', 'LastName': 'van den Beld', 'Affiliation': 'Department of Internal Medicine, Groene Hart Hospital, Gouda, The Netherlands.'}, {'ForeName': 'Wietske', 'Initials': 'W', 'LastName': 'Hermes', 'Affiliation': 'Department of Obstetrics and Gynaecology, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'Solrun', 'Initials': 'S', 'LastName': 'Vidarsdottir', 'Affiliation': 'Department of Internal Medicine, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'Anneke G', 'Initials': 'AG', 'LastName': 'Veldhuis-Vlug', 'Affiliation': 'Department of Internal Medicine, Medical Center Jan van Goyen, Amsterdam, The Netherlands.'}, {'ForeName': 'Remke C', 'Initials': 'RC', 'LastName': 'Dullemond', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'Henrique J', 'Initials': 'HJ', 'LastName': 'Jansen', 'Affiliation': ""Department of Internal Medicine, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Sueters', 'Affiliation': 'Department of Obstetrics and Gynaecology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Eelco J P', 'Initials': 'EJP', 'LastName': 'de Koning', 'Affiliation': 'Department of Medicine, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Judith O E H', 'Initials': 'JOEH', 'LastName': 'van Laar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Pleun', 'Initials': 'P', 'LastName': 'Wouters-van Poppel', 'Affiliation': 'Department of Internal Medicine, Máxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Marina E', 'Initials': 'ME', 'LastName': 'Sanson-van Praag', 'Affiliation': 'Department of Internal Medicine, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Eline S', 'Initials': 'ES', 'LastName': 'van den Akker', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Catherine B', 'Initials': 'CB', 'LastName': 'Brouwer', 'Affiliation': 'Department of Internal Medicine, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Brenda B', 'Initials': 'BB', 'LastName': 'Hermsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Bert Jan', 'Initials': 'BJ', 'LastName': 'Potter van Loon', 'Affiliation': 'Department of Internal Medicine, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Olivier W H', 'Initials': 'OWH', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Center Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Bastiaan E', 'Initials': 'BE', 'LastName': 'de Galan', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Center Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reinier de Graaf Hospital, Delft, The Netherlands.'}, {'ForeName': 'Johanna A M', 'Initials': 'JAM', 'LastName': 'Wijbenga', 'Affiliation': 'Department of Internal Medicine, Reinier de Graaf Hospital, Delft, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'de Boer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Arianne C', 'Initials': 'AC', 'LastName': 'van Bon', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Flip W', 'Initials': 'FW', 'LastName': 'van der Made', 'Affiliation': 'Department of Obstetrics and Gynaecology, Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Silvia A', 'Initials': 'SA', 'LastName': 'Eskes', 'Affiliation': 'Department of Internal Medicine, Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Zandstra', 'Affiliation': 'Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'van Houtum', 'Affiliation': 'Department of Internal Medicine, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'Babette A M', 'Initials': 'BAM', 'LastName': 'Braams-Lisman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Tergooi, Blaricum, The Netherlands.'}, {'ForeName': 'Catharina R G M', 'Initials': 'CRGM', 'LastName': 'Daemen-Gubbels', 'Affiliation': 'Department of Internal Medicine, Tergooi, Blaricum, The Netherlands.'}, {'ForeName': 'Maurice G A J', 'Initials': 'MGAJ', 'LastName': 'Wouters', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'IJzerman', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Nico A', 'Initials': 'NA', 'LastName': 'Mensing van Charante', 'Affiliation': 'Department of Obstetrics and Gynaecology, Dijklander Hospital, Hoorn, The Netherlands.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Zwertbroek', 'Affiliation': 'Department of Internal Medicine, Dijklander Hospital, Hoorn, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, VU University Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'Evers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Ben Willem', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Australia, Melbourne, The Netherlands.'}, {'ForeName': 'Harold W', 'Initials': 'HW', 'LastName': 'de Valk', 'Affiliation': 'Department of Internal Medicine and Endocrinology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Floris', 'Initials': 'F', 'LastName': 'Groenendaal', 'Affiliation': 'Department of Neonatology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Christiana A', 'Initials': 'CA', 'LastName': 'Naaktgeboren', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Painter', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'J Hans', 'Initials': 'JH', 'LastName': 'deVries', 'Affiliation': 'Department of Internal Medicine, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Franx', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Bas B', 'Initials': 'BB', 'LastName': 'van Rijn', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-029808']
150,31443102,Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants.,"BACKGROUND


Infant gut dysbiosis, often associated with low abundance of bifidobacteria, is linked to impaired immune development and inflammation-a risk factor for increased incidence of several childhood diseases. We investigated the impact of B. infantis EVC001 colonization on enteric inflammation in a subset of exclusively breastfed term infants from a larger clinical study.
METHODS


Stool samples (n = 120) were collected from infants randomly selected to receive either 1.8 × 10 10  CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal. The fecal microbiome was analyzed using 16S ribosomal RNA, proinflammatory cytokines using multiplexed immunoassay, and fecal calprotectin using ELISA at three time points: days 6 (Baseline), 40, and 60 postnatal.
RESULTS


Fecal calprotectin concentration negatively correlated with Bifidobacterium abundance (P < 0.0001; ρ = -0.72), and proinflammatory cytokines correlated with Clostridiaceae and Enterobacteriaceae, yet negatively correlated with Bifidobacteriaceae abundance. Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
CONCLUSION


Our findings indicate that gut dysbiosis (absence of B. infantis) is associated with increased intestinal inflammation. Early addition of EVC001 to diet represents a novel strategy to prevent enteric inflammation during a critical developmental phase.",2019,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","['exclusively breastfed infants', 'Stool samples (n\u2009=\u2009120']","['CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal']","['Proinflammatory cytokines', 'intestinal inflammation', 'fecal microbiome', 'Fecal calprotectin concentration', 'enteric inflammation', 'proinflammatory cytokines']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",1010.0,0.0603489,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Henrick', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA. bhenrick2@unl.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chew', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Casaburi', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Frese', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Morrison Microscopy Core Research Facility, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Smilowitz', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0533-2']
151,31141195,Population pharmacokinetics of abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes.,"AIMS


Describe the pharmacokinetics (PK) of the antiretroviral drugs abacavir and lamivudine in malnourished paediatric patients and relate to viral load outcomes after 12 and 48 weeks of treatment.
METHODS


Severely malnourished human immunodeficiency virus-infected children were randomized to early (within 14 days) or delayed (after nutritional recovery) initiation of antiretroviral treatment (ART) using World Health Organization weight-band dosages. Abacavir and lamivudine concentrations were measured as a secondary objective on day 1 and day 14 and patients were followed-up to week 48. Population PK of abacavir and lamivudine were described using NONMEM.
RESULTS


In total, 623 abacavir and 627 lamivudine concentrations were collected from 75 paediatric patients aged 0.1-10.8 (median 1.4) years. Abacavir PK was described by a 2-compartment model, patients randomized to early ART showed increased bioavailability of 31%. Apparent clearance (CL/F, L/h/7 kg) of abacavir increased from day 1 to day 14 from 3.33 (95% confidence interval 2.71-4.12) to 5.86 (95% confidence interval 4.78-7.3). A 1-compartment model described lamivudine PK, variability on CL/F was explained by maturation with age, with age at half-matured CL/F being 4 months. For both drugs allometrically scaled total body weight was related to CL/F and apparent volume of distribution. PK exposure did not correlate with virological outcomes or death at 12 or 48 weeks.
CONCLUSION


Increases in Abacavir's CL/F between day 1 to day 14, bioavailability and PK variability with early start of ART was found in this cohort of severely malnourished children; however, these changes did not influence virological outcomes. The study supports the use of weight-band dosage tables.",2019,"PK exposure did not correlate with virological outcomes or death at 12 or 48 weeks.
","['75 paediatric patients aged 0.1-10.8 (median 1.4) years', 'Severely malnourished human immunodeficiency virus-infected children', 'malnourished paediatric patients and relate to viral load outcomes after 12 and 48\xa0weeks of treatment', 'severely malnourished human immunodeficiency virus-infected children']","['lamivudine PK', 'abacavir and lamivudine', 'antiretroviral drugs abacavir and lamivudine', 'Abacavir PK', 'Abacavir and lamivudine', 'antiretroviral treatment (ART) using World Health Organization weight-band dosages']","['bioavailability and PK variability', 'total body weight', 'bioavailability', 'Apparent clearance (CL/F, L/h/7\xa0kg) of abacavir', 'virological outcomes or death']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",75.0,0.0908955,"PK exposure did not correlate with virological outcomes or death at 12 or 48 weeks.
","[{'ForeName': 'Moherndran', 'Initials': 'M', 'LastName': 'Archary', 'Affiliation': 'Department of Paediatrics and Children Health, King Edward VIII Hospital, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mcllleron', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Raziya', 'Initials': 'R', 'LastName': 'Bobat', 'Affiliation': 'Department of Paediatrics and Children Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'LaRussa', 'Affiliation': 'Department of Paediatrics, College of Physicians & Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Thobekile', 'Initials': 'T', 'LastName': 'Sibaya', 'Affiliation': 'Department of Paediatrics and Children Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Lubbe', 'Initials': 'L', 'LastName': 'Wiesner', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hennig', 'Affiliation': 'School of Pharmacy, The University of Queensland, Brisbane, QLD, Australia.'}]",British journal of clinical pharmacology,['10.1111/bcp.13998']
152,31077425,Therapeutic concentration achievement and allograft survival comparing usage of conventional tacrolimus doses and CYP3A5 genotype-guided doses in renal transplantation patients.,"AIMS


Although cytochromeP450(CYP)3A5 gene polymorphism affects personalized tacrolimus doses, there is no consensus as to whether CYP3A5 genotypes should be determined to adjust the doses. The aims were to compare the therapeutic ranges and clinical outcomes between the conventional and genotype-guided tacrolimus doses.
METHODS


This randomized controlled study compared 63 cases of the conventional tacrolimus dose group (0.1 mg/kg/day) with 62 cases of the genotype-guided doses group of 0.125, 0.1 and 0.08 mg/kg for CYP3A5*1/*1, *1/*3, and *3/*3 genotypes for the initial 3 days of kidney transplantation. After day 3, dose adjustment occurred in both groups to achieve therapeutic concentrations.
RESULTS


The genotype-guided group had an increased proportion of patients with tacrolimus concentrations in the therapeutic range at the steady state on day 3 (40.3 vs 23.8%, P = .048). A lower proportion of over-therapeutic concentration patients was noted in the genotype-guided group in the CYP3A5*3/*3 genotype (9.7 vs 27%, P = .013). Unexpectedly, more delayed graft functions (DGFs) were in the genotype-guided group (41.9 vs 22.2%, P = .018) especially in the CYP3A5*1/*1 participants who might have had an aggravated DGF by a longer ischaemic time and higher serum donor creatinine levels than in the control group. There were no significant differences of glomerular filtration rates or graft or patient survivals over a median 37-month follow-up period.
CONCLUSIONS


Determination of the CYP3A5 genotype improved therapeutic range achievement. CYP3A5*1/*1 patients who have high risks of DGF should be closely monitored because of an increased risk of DGF and reduced glomerular filtration rate with high tacrolimus doses.",2019,"There were no significant differences of glomerular filtration rates or graft or patient survivals over a median 37-month follow-up period.
","['renal transplantation patients', '63 cases of the']",['conventional tacrolimus'],"['delayed graft functions (DGFs', 'glomerular filtration rates or graft or patient survivals', 'Therapeutic concentration achievement and allograft survival', 'therapeutic range achievement', 'ischaemic time and higher serum donor creatinine levels', 'glomerular filtration rate', 'proportion of patients with tacrolimus concentrations', 'proportion of over-therapeutic concentration patients']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C1566590', 'cui_str': 'Delayed Graft Function'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]",,0.0421589,"There were no significant differences of glomerular filtration rates or graft or patient survivals over a median 37-month follow-up period.
","[{'ForeName': 'Sirirat', 'Initials': 'S', 'LastName': 'Anutrakulchai', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Cholatip', 'Initials': 'C', 'LastName': 'Pongskul', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kittrawee', 'Initials': 'K', 'LastName': 'Kritmetapak', 'Affiliation': 'Division of Nephrology, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Chulaporn', 'Initials': 'C', 'LastName': 'Limwattananon', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Thailand.'}, {'ForeName': 'Suda', 'Initials': 'S', 'LastName': 'Vannaprasaht', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}]",British journal of clinical pharmacology,['10.1111/bcp.13980']
153,31108564,The effect of providing prescribing recommendations on appropriate prescribing: A cluster-randomized controlled trial in older adults in a preoperative setting.,"AIMS


The Systematic Tool to Reduce Inappropriate Prescribing is a method to assess patient's medication and has been incorporated into a clinical decision support system: STRIP Assistant. Our aim was to evaluate the effect of recommendations generated using STRIP Assistant on appropriate prescribing and mortality in a preoperative setting.
METHODS


This cluster-randomized controlled trial was carried out at the preoperative geriatric outpatient clinic. Residents who performed a comprehensive geriatric assessment were randomized to the control group and intervention group in a 1:1 ratio. Visiting patients aged 70 years or older on 5 or more medications were included.
INTERVENTION


prescribing recommendations were generated by a physician using STRIP Assistant and given to the resident. Control group residents performed a medication review according to usual care.
PRIMARY OUTCOME


number of medication changes made because of potential prescribing omissions (PPOs), potentially inappropriate medications (PIMs), and suboptimal dosages according to the prescribing recommendations. Secondary outcome: 3-month postoperative mortality.
RESULTS


65 intervention and 59 control patients were included, attended by 34 residents. Significantly more medication changes because of PPOs and PIMs were made in the intervention group than in the control group (PPOs 26.2% vs 3.4%, odds ratio 0.04 [95% confidence interval 0.003-0.46] P < .05; PIMS 46.2% vs 15.3% odds ratio 0.14 [95% confidence interval 0.07-0.57] P < .005). There were no differences in dose adjustments or in postoperative mortality.
CONCLUSION


Prescribing recommendations generated with the help of STRIP Assistant improved appropriate prescribing in a preoperative geriatric outpatient clinic but did not affect postoperative mortality.",2019,"Significantly more medication changes because of PPOs and PIMs were made in the intervention group than in the control group (PPOs 26.2% vs 3.4%, odds ratio 0.04 [95% confidence interval 0.003-0.46] P < .05; PIMS 46.2% vs 15.3% odds ratio 0.14 [95% confidence interval 0.07-0.57] P < .005).","['older adults in a preoperative setting', 'Residents who performed a comprehensive geriatric assessment', 'preoperative geriatric outpatient clinic', '65 intervention and 59 control patients were included, attended by 34 residents', 'Visiting patients aged 70\xa0years or older on 5 or more medications were included']",['STRIP Assistant'],"['postoperative mortality', 'PPOs and PIMs', 'number of medication changes made because of potential prescribing omissions (PPOs), potentially inappropriate medications (PIMs), and suboptimal dosages according to the prescribing recommendations']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1321564', 'cui_str': 'Strip'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C4042848', 'cui_str': 'Potentially Inappropriate Medications'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]",,0.0735976,"Significantly more medication changes because of PPOs and PIMs were made in the intervention group than in the control group (PPOs 26.2% vs 3.4%, odds ratio 0.04 [95% confidence interval 0.003-0.46] P < .05; PIMS 46.2% vs 15.3% odds ratio 0.14 [95% confidence interval 0.07-0.57] P < .005).","[{'ForeName': 'Marijke Nynke', 'Initials': 'MN', 'LastName': 'Boersma', 'Affiliation': 'Department of Geriatrics and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), UMC Utrecht, The Netherlands.'}, {'ForeName': 'Corlina Johanna Alida', 'Initials': 'CJA', 'LastName': 'Huibers', 'Affiliation': 'Department of Geriatrics and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), UMC Utrecht, The Netherlands.'}, {'ForeName': 'Anna Clara', 'Initials': 'AC', 'LastName': 'Drenth-van Maanen', 'Affiliation': 'Department of Geriatrics and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), UMC Utrecht, The Netherlands.'}, {'ForeName': 'Mariëlle Henriëtte', 'Initials': 'MH', 'LastName': 'Emmelot-Vonk', 'Affiliation': 'Department of Geriatrics and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), UMC Utrecht, The Netherlands.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Wilting', 'Affiliation': 'Department of Clinical Pharmacy, UMC Utrecht, The Netherlands.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Knol', 'Affiliation': 'Department of Geriatrics and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), UMC Utrecht, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.13987']
154,32235688,The Daily Mile Is Able to Improve Cardiorespiratory Fitness When Practiced Three Times a Week.,"The Daily Mile is a promising initiative aimed at removing some of the barriers to physical activity in the school setting. This quasi-experimental study investigated the dose-effect of The Daily Mile on cardiorespiratory fitness, waist-to-height ratio, and body mass index (BMI) after a period of 3- and 6-months. A total of 279 students (mean age = 9 ± 1 years) participated in The Daily Mile while 269 students (mean age = 9 ± 1 years) did not (control group). A posteriori, the classes performing The Daily Mile on average two times per week were included in the 2_times subgroup, while those performing the activity on average three times per week in the 3_times subgroup. A significant difference was observed in favor of the experimental compared to the control group in the 6 Minute Run Test (F = 13.932,  p  = 0.008). Moreover, the improvement of the 6-minute run test was more pronounced for 3_times (effect size = 0.51) rather than for the 2_times subgroup (effect size = 0.29). No differences were observed in waist-to-height ratio and BMI scores. In conclusion, teachers are strongly recommended to implement The Daily Mile at least three times a week to see appreciable effects on cardiorespiratory fitness.",2020,"A significant difference was observed in favor of the experimental compared to the control group in the 6 Minute Run Test (F = 13.932,  p  = 0.008).",['279 students (mean age = 9 ± 1 years) participated in The Daily Mile while 269 students (mean age = 9 ± 1 years) did not (control group'],[],"['cardiorespiratory fitness, waist-to-height ratio, and body mass index (BMI', 'Cardiorespiratory Fitness', 'cardiorespiratory fitness', 'waist-to-height ratio and BMI scores']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0331865', 'cui_str': 'miles'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",279.0,0.0146046,"A significant difference was observed in favor of the experimental compared to the control group in the 6 Minute Run Test (F = 13.932,  p  = 0.008).","[{'ForeName': 'Paolo Riccardo', 'Initials': 'PR', 'LastName': 'Brustio', 'Affiliation': 'NeuroMuscular Function Research Group, School of Exercise and Sport Sciences, Department of Medical Sciences, University of Turin, 10143 Turin, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mulasso', 'Affiliation': 'NeuroMuscular Function Research Group, School of Exercise and Sport Sciences, Department of Medical Sciences, University of Turin, 10143 Turin, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Lupo', 'Affiliation': 'NeuroMuscular Function Research Group, School of Exercise and Sport Sciences, Department of Medical Sciences, University of Turin, 10143 Turin, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Massasso', 'Affiliation': ""Dipartimento di Prevenzione dell'ASL TO 4, 10072 Caselle Torinese, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Rainoldi', 'Affiliation': 'NeuroMuscular Function Research Group, School of Exercise and Sport Sciences, Department of Medical Sciences, University of Turin, 10143 Turin, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Boccia', 'Affiliation': 'NeuroMuscular Function Research Group, School of Exercise and Sport Sciences, Department of Medical Sciences, University of Turin, 10143 Turin, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17062095']
155,32235690,"Effect of Steamed Potato Bread Intake on Glucose, Lipids, and Urinary Na +  and K + : A Randomized Controlled Trial with Adolescents.","Although potatoes are highly nutritious, many epidemiological studies have connected their consumption with abnormal lipids, diabetes, and hypertension. Steamed potato bread has recently become one of China's staple foods. A randomized controlled trial was designed to evaluate the effect of steamed potato bread consumption on Chinese adolescents. Four classes from a high school were randomly selected and assigned to the intervention group (two classes) or control group (two classes). The steamed wheat bread (100% raw wheat flour) and potato bread (raw wheat flour to cooked potato flour ratio of 3:7) were provided to the control group and intervention group as staple food once a school day for 8 weeks, respectively. Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg,  p  = 0.010), insulin (-4.35 mIU/L,  p  < 0.001), total cholesterol (-0.13 mmol/L,  p  = 0.032), and high-density lipoproteins cholesterol (-0.07 mmol/L,  p  = 0.010). The urinary level of Na + /K +  did not differ between the groups. In conclusion, the intake of steamed potato bread for 8 weeks resulted in positive effects on the total cholesterol and insulin profiles but a negative effect on the systolic blood pressure and high-density lipoproteins cholesterol of adolescents.",2020,"Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg,  p  = 0.010), insulin (-4.35 mIU/L,  p  < 0.001), total cholesterol (-0.13 mmol/L,  p  = 0.032), and high-density lipoproteins cholesterol (-0.07 mmol/L,  p  = 0.010).","['Four classes from a high school', 'Adolescents', 'Chinese adolescents']","['Steamed Potato Bread Intake', 'steamed potato bread consumption']","['total cholesterol and insulin profiles', 'systolic blood pressure', 'total cholesterol', 'systolic blood pressure and high-density lipoproteins cholesterol of adolescents', 'urinary level of Na + /K ', 'Glucose, Lipids, and Urinary Na +  and K + ', 'high-density lipoproteins cholesterol']","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0038225', 'cui_str': 'Steam'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0556171', 'cui_str': 'Bread intake'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",,0.038516,"Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg,  p  = 0.010), insulin (-4.35 mIU/L,  p  < 0.001), total cholesterol (-0.13 mmol/L,  p  = 0.032), and high-density lipoproteins cholesterol (-0.07 mmol/L,  p  = 0.010).","[{'ForeName': 'Haiquan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing 100081, China.'}, {'ForeName': 'Yanzhi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing 100081, China.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing 100081, China.'}, {'ForeName': 'Yunqian', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing 100081, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing 100081, China.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing 100050, China.'}, {'ForeName': 'Junmao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing 100081, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17062096']
156,31112621,"Pharmacokinetics and safety of tobramycin nebulization with the I-neb and PARI-LC Plus in children with cystic fibrosis: A randomized, crossover study.","AIMS


We aimed to compare the pharmacokinetics (PK) and safety profile of tobramycin inhalation solution (TIS) using the I-neb device to the standard PARI-LC Plus nebulizer in children with cystic fibrosis.
METHODS


A randomized, open-label, crossover study was performed. In 2 separate study visits, blood samples from 22 children were collected following TIS nebulization with I-neb (75 mg) and PARI-LC Plus (300 mg). Study visits were separated by 1 month, in which 1 of the study nebulizers was used twice daily. Tobramycin PK for both nebulizers was established using measured tobramycin concentrations and Bayesian PK modelling software. Hearing and renal function tests were performed to test for aminoglycoside associated toxicity. In addition to standard estimated glomerular filtration rate values, biomarkers for tubular injury (KIM-1 and NAG) were measured. Patient and nebulizer satisfaction were assessed.
RESULTS


Inhalations were well tolerated and serum trough concentrations below the predefined toxic limit were reached with no significant differences in PK parameters between nebulizers. Results of audiometry and estimated glomerular filtration rate revealed no abnormalities. However, increased urinary NAG/creatinine ratios at visit 2 for both nebulizers suggest TIS-induced subclinical tubular kidney injury. Nebulization time was 50% shorter and patient satisfaction was significantly higher with the I-neb.
CONCLUSIONS


Nebulization of 75 mg TIS with the I-neb in children with cystic fibrosis resulted in comparable systemic exposure to 300 mg TIS with the PARI-LC Plus and was well tolerated and preferred over the PARI-LC Plus. Long-term safety of TIS nebulization should be monitored clinically, especially regarding the effects on tubular kidney injury.",2019,"RESULTS


Inhalations were well tolerated and serum trough concentrations below the predefined toxic limit were reached with no significant differences in PK parameters between nebulizers.",['children with cystic fibrosis'],"['standard PARI-LC Plus nebulizer', 'tobramycin inhalation solution (TIS', 'PARI-LC Plus', 'Tobramycin PK', 'tobramycin nebulization with the I-neb and PARI-LC', 'PARI-LC']","['Nebulization time', 'Hearing and renal function tests', 'glomerular filtration rate values, biomarkers for tubular injury (KIM-1 and NAG', 'urinary NAG/creatinine ratios', 'tolerated and preferred over the PARI-LC', 'tolerated and serum trough concentrations', 'patient satisfaction']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0027524', 'cui_str': 'Nebulizers'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C1154181', 'cui_str': 'Inhalation Solution'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022662', 'cui_str': 'Kidney Function Tests'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332208', 'cui_str': 'Tubular (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",22.0,0.0208693,"RESULTS


Inhalations were well tolerated and serum trough concentrations below the predefined toxic limit were reached with no significant differences in PK parameters between nebulizers.","[{'ForeName': 'Annelies J', 'Initials': 'AJ', 'LastName': 'van Velzen', 'Affiliation': 'Central Hospital Pharmacy, The Hague, The Netherlands.'}, {'ForeName': 'Joris W F', 'Initials': 'JWF', 'LastName': 'Uges', 'Affiliation': 'Central Hospital Pharmacy, The Hague, The Netherlands.'}, {'ForeName': 'Harry G M', 'Initials': 'HGM', 'LastName': 'Heijerman', 'Affiliation': 'Department of Pulmonology, Haga Teaching Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Bert G M', 'Initials': 'BGM', 'LastName': 'Arets', 'Affiliation': ""Department of Pediatric Pulmonology, University Medical Center Utrecht-Wilhelmina Children's hospital, Utrecht, The Netherlands.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Nuijsink', 'Affiliation': ""Department of Pediatric Pulmonology, Haga Teaching Hospital-Juliana Children's hospital, The Hague, The Netherlands.""}, {'ForeName': 'Els C', 'Initials': 'EC', 'LastName': 'van der Wiel-Kooij', 'Affiliation': ""Department of Pediatrics, div Respiratory Medicine and Allergology, Erasmus MC-Sophia Children's Hospital, University Medical Center, Rotterdam, The Netherlands.""}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'van Maarseveen', 'Affiliation': 'Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Gijsbert A', 'Initials': 'GA', 'LastName': 'van Zanten', 'Affiliation': 'Department of Otorhinolaryngology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Pullens', 'Affiliation': ""Department of Otorhinolaryngology, Erasmus MC-Sophia Children's Hospital, University Medical Center, Rotterdam, The Netherlands.""}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hettie M', 'Initials': 'HM', 'LastName': 'Janssens', 'Affiliation': ""Department of Pediatrics, div Respiratory Medicine and Allergology, Erasmus MC-Sophia Children's Hospital, University Medical Center, Rotterdam, The Netherlands.""}]",British journal of clinical pharmacology,['10.1111/bcp.13988']
157,32209984,"Surface-Specific Caries Preventive Effect of an Intervention Comprising Fissure Sealant, Povidone-Iodine and Fluoride Varnish in a Remote Indigenous Community in Australia.","This study evaluates the effect of a topical intervention comprising of fissure sealant, povidone-iodine, and fluoride varnish in preventing caries on occlusal, approximal, and smooth surfaces. This three-year clinical trial was conducted in a remote Indigenous community of Australia. All schoolchildren (age range: 4-17) were invited to participate; those with parental consents to receive three-annual epidemiological examinations and interventions constituted the experimental group, while those with consents for only the epidemiological examination formed a comparison group. The intervention group received an annual application of fissure sealant, povidone-iodine and fluoride varnish for two consecutive years along with the restoration of any cavitated lesions, while the comparison group did not receive any intervention except for the usual care that included emergency treatment and restorations. Incipient and advanced caries were recorded in the permanent dentition while data on confounding variables were collected through questionnaires. Caries increment and progression were the outcome variables. A total of 408 children participated in the baseline examination, 208 finished the study. After adjusting for confounders, the prevented fraction (PF) on occlusal surfaces for advanced caries in the experimental group was 76.1% (mean difference- -0.35, 95% CI: -0.67-0.04), while the PF for progression from incipient to advanced caries was 100%(mean difference- -0.30, 95% CI: -0.52-0.09). The mean number of smooth surfaces that progressed from incipient to advanced caries in the comparison group was more than twice that of the experimental group, the mean difference was -0.25 (95% CI: -0.46--0.03) with a PF of 61%. The intervention was only effective in preventing advanced caries on occlusal surfaces and in halting the progression of caries on occlusal and smooth surfaces but not on approximal caries.",2020,The intervention was only effective in preventing advanced caries on occlusal surfaces and in halting the progression of caries on occlusal and smooth surfaces but not on approximal caries.,"['All schoolchildren (age range: 4-17) were invited to participate; those with', 'remote Indigenous community of Australia', 'Remote Indigenous Community in Australia', '408 children participated in the baseline examination, 208 finished the study']","['comparison group did not receive any intervention except for the usual care that included emergency treatment and restorations', 'annual application of fissure sealant, povidone-iodine and fluoride varnish', 'parental consents to receive three-annual epidemiological examinations and interventions constituted the experimental group, while those with consents for only the epidemiological examination formed a comparison group', 'fissure sealant, povidone-iodine, and fluoride varnish', 'Fissure Sealant, Povidone-Iodine and Fluoride Varnish']","['prevented fraction (PF) on occlusal surfaces for advanced caries', 'mean number of smooth surfaces', 'caries on occlusal, approximal, and smooth surfaces', 'Incipient and advanced caries']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013969', 'cui_str': 'Therapy, Emergency'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0016168', 'cui_str': 'Fissure Sealants'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0600634', 'cui_str': 'Parental Consent'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]","[{'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205357', 'cui_str': 'Smooth (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0205256', 'cui_str': 'Incipient (qualifier value)'}]",408.0,0.0432207,The intervention was only effective in preventing advanced caries on occlusal surfaces and in halting the progression of caries on occlusal and smooth surfaces but not on approximal caries.,"[{'ForeName': 'Santosh K', 'Initials': 'SK', 'LastName': 'Tadakamadla', 'Affiliation': 'School of Dentistry and Oral Health, Griffith University, Gold Coast, Queensland, QLD 4215, Australia.'}, {'ForeName': 'Ratilal', 'Initials': 'R', 'LastName': 'Lalloo', 'Affiliation': 'School of Dentistry, The University of Queensland, Herston, Queensland, QLD 4072, Australia.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Kroon', 'Affiliation': 'School of Dentistry and Oral Health, Griffith University, Gold Coast, Queensland, QLD 4215, Australia.'}, {'ForeName': 'Newell W', 'Initials': 'NW', 'LastName': 'Johnson', 'Affiliation': 'School of Dentistry and Oral Health, Griffith University, Gold Coast, Queensland, QLD 4215, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17062114']
158,32304300,Celecoxib versus mefenamic acid in the treatment of primary dysmenorrhea.,Background The objective was to compare the effectiveness and tolerability of mefenamic acid and celecoxib in women with primary dysmenorrhea (PD) and to compare the quality of life of study participants pre- and post-treatment. Materials and methods This was a randomized crossover clinical trial conducted among sexually inactive female adults aged 18-25 years with PD. Participants were asked to rate their pain score and answer a validated quality of life questionnaire (EQ-5D-3L) before and after consumption of each medication in two menstrual cycles. The effectiveness of celecoxib and mefenamic acid in treating PD was compared with regard to reduction in pain score and the need for medical leave and rescue therapy. Drug tolerability was determined by comparing the occurrence of side effects of both drugs. Quality of life scores pre- and post-intervention were measured and compared. Results Mefenamic acid had a comparable effect to celecoxib in relieving symptoms of PD. Both drugs were equally tolerable and showed similar impacts on quality of life. Conclusions This study demonstrated that mefenamic acid and celecoxib had similar effectiveness in improving pain score and quality of life in women with PD.,2020,This study demonstrated that mefenamic acid and celecoxib had similar effectiveness in improving pain score and quality of life in women with PD.,"['primary dysmenorrhea', 'sexually inactive female adults aged 18-25 years with PD', 'women with PD', 'women with primary dysmenorrhea (PD']","['mefenamic acid', 'Celecoxib', 'Mefenamic acid', 'celecoxib and mefenamic acid', 'mefenamic acid and celecoxib', 'celecoxib']","['relieving symptoms of PD', 'Drug tolerability', 'pain score and quality of life', 'Quality of life scores pre- and post-intervention', 'effectiveness and tolerability', 'rate their pain score and answer a validated quality of life questionnaire (EQ-5D-3L', 'pain score', 'quality of life']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0025152', 'cui_str': 'mefenamic acid'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0912067,This study demonstrated that mefenamic acid and celecoxib had similar effectiveness in improving pain score and quality of life in women with PD.,"[{'ForeName': 'Nurul Iftida', 'Initials': 'NI', 'LastName': 'Basri', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.'}, {'ForeName': 'Nur Azurah', 'Initials': 'NA', 'LastName': 'Abd Ghani', 'Affiliation': 'Department of Obstetrics and Gynaecology, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Zaleha Abdullah', 'Initials': 'ZA', 'LastName': 'Mahdy', 'Affiliation': 'Department of Obstetrics and Gynaecology, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohd Rizal', 'Initials': 'MR', 'LastName': 'Abdul Manaf', 'Affiliation': 'Department of Community Health, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nor Azlin', 'Initials': 'NA', 'LastName': 'Mohamed Ismail', 'Affiliation': 'Department of Obstetrics and Gynaecology, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}]",Hormone molecular biology and clinical investigation,['10.1515/hmbci-2019-0069']
159,32301501,Response to Inhibition of Receptor-Interacting Protein Kinase 1 (RIPK1) in Active Plaque Psoriasis: A Randomized Placebo-Controlled Study.,"Receptor-interacting protein kinase 1 (RIPK1), a regulator of inflammation and cell death, is a potential therapeutic target in immune-mediated inflammatory diseases (IMIDs). The objective of this phase IIa multicenter, randomized, double-blind, placebo-controlled study was to evaluate safety, tolerability pharmacokinetics, pharmacodynamics, and preliminary efficacy of GSK2982772, a RIPK1 inhibitor, in plaque-type psoriasis. Psoriasis patients (N = 65) were randomized to 60 mg twice daily (b.i.d.) or three times daily (t.i.d.), or placebo for 84 days. Most adverse events (AEs) were mild with no severe drug-related AEs reported. Plaque Lesion Severity Sum improved with b.i.d. treatment compared with placebo; interpretation of t.i.d. treatment results was complicated by a high placebo response. Reductions in epidermal thickness and infiltration by CD3+ T cells in the epidermis and dermis were observed compared with placebo. Results support the rationale for additional studies on RIPK1 inhibition in IMIDs.",2020,Reductions in epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis were observed compared with placebo.,"['plaque-type psoriasis', 'Psoriasis patients (N=65', 'active plaque psoriasis']","['receptor-interacting protein kinase 1 (RIPK1', 'placebo']","['safety, tolerability pharmacokinetics, pharmacodynamics', 'epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis', 'Plaque Lesion Severity Sum', 'adverse events (AEs']","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}]","[{'cui': 'C0297981', 'cui_str': 'RIPK1 protein, human'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0241148', 'cui_str': 'Cutaneous plaque'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.614395,Reductions in epidermal thickness and infiltration by CD3+ T cells in epidermis and dermis were observed compared with placebo.,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berger', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'InnovaDerm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'The Rockefeller University, New York, New York, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Scott', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Tompson', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Simeoni', 'Affiliation': 'GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bertin', 'Affiliation': 'GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Peter Tak', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1852']
160,32300859,Scheduled intravenous acetaminophen versus nonsteroidal anti-inflammatory drugs (NSAIDs) for better short-term outcomes after esophagectomy for esophageal cancer.,"PURPOSE


To evaluate the effect of scheduled intravenous acetaminophen administration versus nonsteroidal anti-inflammatory drugs on postoperative pain and short-term outcomes after esophagectomy.
METHODS


The subjects of this study were 150 consecutive patients who underwent esophagectomy for esophageal cancer. Seventy-seven patients received scheduled intravenous acetaminophen and the other 73 received NSAIDs enterally for postoperative pain management. We compared the postoperative pain and short-term outcomes between the groups. Inverse probability of treatment weighting (IPTW) based on propensity scores was used to control for selection bias.
RESULTS


The visual analog scale (VAS) of postoperative pain was lower in the acetaminophen group than in the NSAIDs group, based on the mean values of chest VAS on postoperative days (PODs) 0, 4, 5, and 6 and the mean values of abdomen VAS on PODs 4, 5, and 6. The incidence of anastomotic leakage and postoperative delirium was lower in the acetaminophen group than in the NSAIDs group (anastomotic leakage, odds ratio (OR) 0.3, p = 0.01; postoperative delirium, OR 0.19, p < 0.01).
CONCLUSION


Scheduled intravenous acetaminophen administration is effective and feasible for the postoperative pain management of patients undergoing esophagectomy and may be associated with a lower incidence of anastomotic leakage and postoperative delirium.",2020,"The visual analog scale (VAS) of postoperative pain was lower in the acetaminophen group than in the NSAIDs group, based on the mean values of chest VAS on postoperative days (PODs) 0, 4, 5, and 6 and the mean values of abdomen VAS on PODs 4, 5, and 6.","['150 consecutive patients who underwent esophagectomy for esophageal cancer', 'Seventy-seven patients received scheduled', 'esophageal cancer', 'patients undergoing esophagectomy']","['acetaminophen', 'intravenous acetaminophen', 'nonsteroidal anti-inflammatory drugs (NSAIDs', 'NSAIDs enterally for postoperative pain management', 'nonsteroidal anti-inflammatory drugs']","['postoperative delirium', 'postoperative pain', 'incidence of anastomotic leakage and postoperative delirium', 'postoperative pain and short-term outcomes', 'visual analog scale (VAS) of postoperative pain']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",150.0,0.0354133,"The visual analog scale (VAS) of postoperative pain was lower in the acetaminophen group than in the NSAIDs group, based on the mean values of chest VAS on postoperative days (PODs) 0, 4, 5, and 6 and the mean values of abdomen VAS on PODs 4, 5, and 6.","[{'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Kawakami', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan. tabe@aichi-cc.jp.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Higaki', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hosoi', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Fukaya', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Komori', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nakatochi', 'Affiliation': 'Department of Nursing, Nagoya University Graduate School of Medicine, 1-1-20 Daiko-Minami, Higashi-ku, Nagoya, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nagino', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.'}]",Surgery today,['10.1007/s00595-020-02001-x']
161,30657249,Prehabilitation is feasible in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy and may minimize physical deterioration: results from the REx trial.,"AIM


Rectal cancer patients undergoing neoadjuvant chemoradiotherapy (NACRT) experience physical deterioration and reductions in their quality of life. This feasibility study assessed prehabilitation (a walking intervention) before, during and after NACRT to inform a definitive multi-centred randomized clinical trial (REx trial).
METHODS


Patients planned for NACRT followed by potentially curative surgery were approached (August 2014-March 2016) (www.isrctn.com; 62859294). Prior to NACRT, baseline physical and psycho-social data were recorded using validated tools. Participants were randomized to either the intervention group (exercise counselling session followed by a 13-17 week telephone-guided walking programme) or a control group (standard care). Follow-up testing was undertaken 1-2 weeks before surgery.
RESULTS


Of the 296 screened patients, 78 (26%) were eligible and 48 (61%) were recruited. N = 31 (65%) were men with a mean age of 65.9 years (range 33.7-82.6). Mean intervention duration was 14 weeks with 75% adherence. n = 40 (83%) completed follow-up testing. Both groups recorded reductions in daily walking but the reduction was less in the intervention group although not statistically significant. Participants reported high satisfaction and fidelity to trial procedures.
CONCLUSION


This study demonstrates that prehabilitation is feasible in rectal cancer patients undergoing NACRT. Good recruitment, adherence, retention and patient satisfaction rates support the development of a fully powered trial. The effects of the intervention on physical outcomes were promising.",2019,Both groups recorded reductions in daily walking but the reduction was less in the intervention group although not statistically significant.,"['N = 31 (65%) were men with a mean age of 65.9 years (range 33.7-82.6', 'patients with rectal cancer undergoing', 'Rectal cancer patients undergoing', 'rectal cancer patients undergoing NACRT', 'Patients planned for NACRT followed by potentially curative surgery were approached (August 2014-March 2016', '296 screened patients, 78 (26%) were eligible and 48 (61%) were recruited']","['intervention group (exercise counselling session followed by a 13-17 week telephone-guided walking programme) or a control group (standard care', 'neoadjuvant chemoradiotherapy', 'neoadjuvant chemoradiotherapy (NACRT']","['Good recruitment, adherence, retention and patient satisfaction rates', 'Mean intervention duration', 'daily walking']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.155272,Both groups recorded reductions in daily walking but the reduction was less in the intervention group although not statistically significant.,"[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Moug', 'Affiliation': 'Department of Surgery, Royal Alexandra Hospital, Paisley, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': 'Institute of Sport, Physical Education and Health Sciences, Moray House School of Education, Edinburgh, UK.'}, {'ForeName': 'S J E', 'Initials': 'SJE', 'LastName': 'Barry', 'Affiliation': 'Department of Mathematics and Statistics, Strathclyde University, Glasgow, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mackay', 'Affiliation': 'Department of Surgery, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'R J C', 'Initials': 'RJC', 'LastName': 'Steele', 'Affiliation': 'Head of Cancer Research Division, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Boachie', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Buchan', 'Affiliation': 'Department of Surgery (Patient Representative), Royal Alexandra Hospital, Paisley, UK.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Public Health Nutrition, Division of Cancer Research, Ninewells Medical School, Dundee, UK.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.14560']
162,32293514,Addressing identification bias in the design and analysis of cluster-randomized pragmatic trials: a case study.,"BACKGROUND


Pragmatic trials provide the opportunity to study the effectiveness of health interventions to improve care in real-world settings. However, use of open-cohort designs with patients becoming eligible after randomization and reliance on electronic health records (EHRs) to identify participants may lead to a form of selection bias referred to as identification bias. This bias can occur when individuals identified as a result of the treatment group assignment are included in analyses.
METHODS


To demonstrate the importance of identification bias and how it can be addressed, we consider a motivating case study, the PRimary care Opioid Use Disorders treatment (PROUD) Trial. PROUD is an ongoing pragmatic, cluster-randomized implementation trial in six health systems to evaluate a program for increasing medication treatment of opioid use disorders (OUDs). A main study objective is to evaluate whether the PROUD intervention decreases acute care utilization among patients with OUD (effectiveness aim). Identification bias is a particular concern, because OUD is underdiagnosed in the EHR at baseline, and because the intervention is expected to increase OUD diagnosis among current patients and attract new patients with OUD to the intervention site. We propose a framework for addressing this source of bias in the statistical design and analysis.
RESULTS


The statistical design sought to balance the competing goals of fully capturing intervention effects and mitigating identification bias, while maximizing power. For the primary analysis of the effectiveness aim, identification bias was avoided by defining the study sample using pre-randomization data (pre-trial modeling demonstrated that the optimal approach was to use individuals with a prior OUD diagnosis). To expand generalizability of study findings, secondary analyses were planned that also included patients newly diagnosed post-randomization, with analytic methods to account for identification bias.
CONCLUSION


As more studies seek to leverage existing data sources, such as EHRs, to make clinical trials more affordable and generalizable and to apply novel open-cohort study designs, the potential for identification bias is likely to become increasingly common. This case study highlights how this bias can be addressed in the statistical study design and analysis.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03407638. Registered on 23 January 2018.",2020,"To demonstrate the importance of identification bias and how it can be addressed, we consider a motivating case study, the PRimary care Opioid Use Disorders treatment (PROUD) Trial.",['patients with OUD (effectiveness aim'],"['health interventions', 'PROUD intervention']",['OUD diagnosis'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.080277,"To demonstrate the importance of identification bias and how it can be addressed, we consider a motivating case study, the PRimary care Opioid Use Disorders treatment (PROUD) Trial.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Bobb', 'Affiliation': 'Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA, 98101, USA. Jennifer.F.Bobb@kp.org.'}, {'ForeName': 'Hongxiang', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': 'Department of Biostatistics, University of Washington, 1705 NE Pacific St, Seattle, WA, 98195, USA.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Company, 401 N Washington St # 700, Rockville, MD, 20850, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McCormack', 'Affiliation': 'The Emmes Company, 401 N Washington St # 700, Rockville, MD, 20850, USA.'}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Bradley', 'Affiliation': 'Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA, 98101, USA.'}]",Trials,['10.1186/s13063-020-4148-z']
163,32301204,"Influence of curcumin on glycemic profile, inflammatory markers, and oxidative stress in HIV-infected individuals: A randomized controlled trial.","To evaluate the influence of curcumin supplementation on the glycemic profile, inflammatory markers, and oxidative stress in HIV-infected individuals under antiretroviral therapy. This double-blind, crossover, randomized clinical trial was composed of 20 subjects arranged initially into experimental group (n = 10) and placebo group (n = 10) groups, receiving 1,000 mg curcumin/day or microcrystalline cellulose/day, respectively, during a 30-day period and 12-day washout. Subsequently, the groups were switched to follow the crossover design. Fasting glucose and insulin, IL-10, tumor necrosis factor alpha, malonialdehyde, and reduced glutathione were measured. Food consumption was evaluated as a control variable. Descriptive statistics are presented as mean and standard deviation, and inferential analyses were performed from two-way analysis of variance and the magnitude of the effect. No significant improvements were observed in the glycemic, inflammatory, or oxidative stress profiles. Although the mean serum fasting glucose levels and the homeostatic model assessment index presented qualitative improvement in the CG, this result should be interpreted with caution since the observed variation may represent acceptable fluctuation, in addition to the small difference between the means, added to the large variation observed in the standard deviation. Supplementation with curcumin in HIV-infected individuals undergoing antiretroviral therapy and training did not improve the glycemic, inflammatory, or oxidative stress profiles.",2020,"Fasting glucose and insulin, IL-10, tumor necrosis factor alpha, malonialdehyde, and reduced glutathione were measured.","['20 subjects arranged initially into experimental group (n =\u200910) and', 'HIV-infected individuals under antiretroviral therapy', 'HIV-infected individuals undergoing', 'HIV-infected individuals']","['receiving 1,000\u2009mg curcumin/day or microcrystalline cellulose', 'placebo', 'curcumin supplementation', 'curcumin', 'antiretroviral therapy and training']","['Fasting glucose and insulin, IL-10, tumor necrosis factor alpha, malonialdehyde, and reduced glutathione', 'glycemic profile, inflammatory markers, and oxidative stress', 'Food consumption', 'mean serum fasting glucose levels', 'glycemic, inflammatory, or oxidative stress profiles']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0583334', 'cui_str': 'Serum fasting glucose measurement'}]",,0.057747,"Fasting glucose and insulin, IL-10, tumor necrosis factor alpha, malonialdehyde, and reduced glutathione were measured.","[{'ForeName': 'Tatiane A L', 'Initials': 'TAL', 'LastName': 'da Silva', 'Affiliation': 'Postgraduate Program in Health Science, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'de Medeiros', 'Affiliation': 'Department of Physical Education, University Center UNIFACEX, Natal, Brazil.'}, {'ForeName': 'Rafaela Catherine', 'Initials': 'RC', 'LastName': 'da Silva Cunha de Medeiros', 'Affiliation': 'Postgraduate Program in Health Science, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Radamés M V', 'Initials': 'RMV', 'LastName': 'Medeiros', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Luanda B F C', 'Initials': 'LBFC', 'LastName': 'de Souza', 'Affiliation': 'Postgraduate Program in Pharmaceutical Science, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'de Medeiros', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Ronaldo V T', 'Initials': 'RVT', 'LastName': 'Dos Santos', 'Affiliation': 'Bioscience Department, Federal University of Sao Paulo, UNIFESP, Santos, Brazil.'}, {'ForeName': 'Phelipe W', 'Initials': 'PW', 'LastName': 'de Alcântara Varela', 'Affiliation': 'Postgraduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Leite-Lais', 'Affiliation': 'Department of Nutrition, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Paulo M S', 'Initials': 'PMS', 'LastName': 'Dantas', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}]",Phytotherapy research : PTR,['10.1002/ptr.6683']
164,32303377,"Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial.","BACKGROUND


Current treatment of postdural puncture headache includes epidural blood patch (EBP), which is invasive and may result in rare but severe complications. Sphenopalatine ganglion block is suggested as a simple, minimally invasive treatment for postdural puncture headache. We aimed to investigate the analgesic effect of a transnasal sphenopalatine ganglion block with local anaesthetic vs saline.
METHODS


We conducted a blinded, randomised clinical trial including adults fulfilling the criteria for EBP. Participants received a sphenopalatine ganglion block bilaterally with 1 ml of either local anaesthetic (lidocaine 4% and ropivacaine 0.5%) or placebo (saline). Primary outcome was pain in upright position 30 min post-block, measured on a 0-100 mm VAS.
RESULTS


We randomised 40 patients with an upright median pain intensity of 74 and 84 mm in the local anaesthetic and placebo groups at baseline, respectively. At 30 min after sphenopalatine ganglion block, the median pain intensity in upright position was 26 mm in the local anaesthetic group vs 37 mm in the placebo group (estimated median difference: 5 mm; 95% confidence interval: -14 to 21; P=0.53). In the local anaesthetic group, 50% required an EBP compared with 45% in the placebo group (P=0.76).
CONCLUSIONS


Administration of a sphenopalatine ganglion block with local anaesthetic had no statistically significant effect on pain intensity after 30 min compared with placebo. However, pain was reduced and EBP was avoided in half the patients of both groups, which suggests a major effect not necessarily attributable to local anaesthetics.
CLINICAL TRIAL REGISTRATION


NCT03652714.",2020,"In the local anaesthetic group, 50% required an EBP compared with 45% in the placebo group (P=0.76).
","['adults fulfilling the criteria for EBP', '40 patients with an upright median pain intensity of 74 and 84 mm in the local anaesthetic and placebo groups at baseline, respectively', 'postdural puncture headache']","['Sphenopalatine ganglion block', 'placebo', 'transnasal sphenopalatine ganglion block with local anaesthetic vs saline', 'epidural blood patch (EBP', 'sphenopalatine ganglion block bilaterally with 1 ml of either local anaesthetic (lidocaine 4% and ropivacaine 0.5%) or placebo (saline']","['pain in upright position 30 min post-block, measured on a 0-100 mm VAS', 'median pain intensity in upright position', 'pain', 'EBP', 'pain intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0751188', 'cui_str': 'Post dural puncture headache'}]","[{'cui': 'C0394799', 'cui_str': 'Injection of anesthetic agent into sphenopalatine ganglion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0162649', 'cui_str': 'Epidural lumbar injection of blood patch'}]",40.0,0.790752,"In the local anaesthetic group, 50% required an EBP compared with 45% in the placebo group (P=0.76).
","[{'ForeName': 'Mads S', 'Initials': 'MS', 'LastName': 'Jespersen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Copenhagen Centre for Translational Research, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark. Electronic address: mads.seit.jespersen@regionh.dk.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Jaeger', 'Affiliation': 'Department of Anaesthesia, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Ægidius', 'Affiliation': 'Department of Neurology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Fabritius', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Duch', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rye', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Afshari', 'Affiliation': 'Department of Anaesthesia, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Copenhagen Centre for Translational Research, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.02.025']
165,32303413,Differences and Effects of Metabolic Fate of Individual Amino Acid Loss in High-Efficiency Hemodialysis and Hemodiafiltration.,"OBJECTIVE


The objective of the study was to quantify the loss and arterial blood concentration of the three main classes of amino acids (AAs)-nonessential amino acids (NEAAs), essential amino acids (EAAs), and branched-chain amino acids-as resulting from high-efficiency hemodialysis (HED) and hemodiafiltration (HDF). We moreover aimed to identify the different fates and metabolic effects manifested in patients undergoing hemodialysis and the consequences on body composition and influence of nutritional decline into protein energy wasting.
DESIGN AND METHODS


Identical dialysis monitors, membranes, and dialysate/infusate were used to ensure consistency. Ten patients were recruited and randomized to receive treatment with on-line modern HED and HDF. Arterial plasma concentrations of individual AAs were compared in healthy volunteers and patients undergoing hemodialysis, and AA levels outflowing from the dialyzer were evaluated. Baseline AA plasma levels of patients undergoing hemodialysis were compared with findings obtained 1 year later.
RESULTS


A severe loss of AA with HED/HDF was confirmed: a marked loss of total AAs (5 g/session) was detected, corresponding to more than 65% of all AAs. With regard to individual AAs, glutamine displayed a consistent increase (+150%), whereas all other AAs decreased after 12 months of HD/HDF. Only a few AAs, such as proline, cysteine, and histidine maintained normal levels. The most severe metabolic consequences may result from losses of EAAs such as valine, leucine, and histidine and from NEAAs including proline, cysteine, and glutamic acid eliciting the onset of hypercatabolism threatening muscle mass loss.
CONCLUSION


Dialysis losses, together with the effect of chronic uremia, resulted in a reduction of fundamental EAAs and NEAAs, which progressively led our patients after 12 months to a deterioration of lean mass toward sarcopenia. Therefore, the reintroduction of a correctly balanced AA supplementation in patients undergoing HD to prevent or halt decline of hypercatabolism into cachexia is recommended.",2020,"With regard to individual AAs, glutamine displayed a consistent increase (+150%), whereas all other AAs decreased after 12 months of HD/HDF.","['healthy volunteers and patients undergoing hemodialysis, and AA levels outflowing from the dialyzer were evaluated', 'patients undergoing hemodialysis', 'patients undergoing HD', 'High-Efficiency Hemodialysis and Hemodiafiltration']",[],"['marked loss of total AAs', 'Baseline AA plasma levels', 'Arterial plasma concentrations of individual AAs']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",10.0,0.0342849,"With regard to individual AAs, glutamine displayed a consistent increase (+150%), whereas all other AAs decreased after 12 months of HD/HDF.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Murtas', 'Affiliation': 'Territorial Department of Nephrology and Dialysis, ASSL Cagliari, Cagliari, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Aquilani', 'Affiliation': 'Department of Biology and Biotechnology, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Iadarola', 'Affiliation': 'Department of Biology and Biotechnology, University of Pavia, Pavia, Italy.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Deiana', 'Affiliation': 'Territorial Department of Nephrology and Dialysis, ASSL Cagliari, Cagliari, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Secci', 'Affiliation': 'Territorial Department of Nephrology and Dialysis, ASSL Cagliari, Cagliari, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cadeddu', 'Affiliation': 'Territorial Department of Nephrology and Dialysis, ASSL Cagliari, Cagliari, Italy.'}, {'ForeName': 'Piergiorgio', 'Initials': 'P', 'LastName': 'Bolasco', 'Affiliation': 'Treatment Study Group of Chronic Renal Disease of Italian Society of Nephrology, Cagliari, Italy. Electronic address: pg.bolasco@gmail.com.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2019.12.003']
166,31436896,Efficacy and safety of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate- or prolonged-release tacrolimus.,"BACKGROUND AND AIMS


This multicenter trial compared immediate-release tacrolimus (IR-T) vs prolonged-release tacrolimus (PR-T) in de novo kidney, liver, and heart transplant recipients aged <16 years. Each formulation had similar pharmacokinetic (PK) profiles. Follow-up efficacy and safety results are reported herein.
MATERIALS AND METHODS


Patients, randomized 1:1, received once-daily, PR-T or twice-daily, IR-T within 4 days of surgery. After a 4-week PK assessment, patients continued randomized treatment for 48 additional weeks. At Year 1, efficacy assessments included the number of clinical acute rejections, biopsy-confirmed acute rejection (BCAR) episodes (including severity), patient and graft survival, and efficacy failure (composite of death, graft loss, BCAR, or unknown outcome). Adverse events were assessed throughout.
RESULTS


The study included 44 children. At Year 1, mean ± standard deviation tacrolimus trough levels were 6.6 ± 2.2 and 5.4 ± 1.6 ng/mL, and there were 2 and 7 acute rejection episodes in the PR-T and IR-T groups, respectively. No cases of graft loss or death were reported during the study. The overall efficacy failure rate was 18.2% (PR-T n = 1; IR-T n = 7).
CONCLUSIONS


In pediatric de novo solid organ recipients, the low incidence of BCAR and low efficacy failure rate suggest that PR-T-based immunosuppression is effective and well tolerated to 1-year post-transplantation.",2019,No cases of graft loss or death were reported during the study.,"['Patients', 'de novo kidney-, liver-, and heart-transplant recipients aged <16\xa0years', '44 children', 'de novo pediatric transplant recipients']","['immediate- or prolonged-release tacrolimus', 'immediate-release tacrolimus (IR-T) versus prolonged-release tacrolimus (PR-T', 'tacrolimus']","['graft loss or death', 'number of clinical acute rejections, biopsy-confirmed acute rejection (BCAR) episodes (including severity), patient and graft survival, and efficacy failure (composite of death, graft loss, BCAR, or unknown outcome', 'overall efficacy failure rate', 'Adverse events', 'mean ± standard deviation tacrolimus trough levels', 'similar pharmacokinetic (PK) profiles', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C4544856', 'cui_str': 'Prolonged-release (release characteristic)'}]","[{'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",44.0,0.143325,No cases of graft loss or death were reported during the study.,"[{'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Vondrak', 'Affiliation': 'University Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Parisi', 'Affiliation': 'Ospedale Pediatrico Bambino Gesù, Rome, Italy.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Dhawan', 'Affiliation': ""King's College Hospital, London, UK.""}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Grenda', 'Affiliation': ""The Children's Memorial Health Institute, Warsaw, Poland.""}, {'ForeName': 'Nicholas J A', 'Initials': 'NJA', 'LastName': 'Webb', 'Affiliation': 'Manchester University Foundation Trust, Manchester, UK.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Marks', 'Affiliation': 'Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Debray', 'Affiliation': 'APHP-Hôpital Universitaire Necker, Paris, France.'}, {'ForeName': 'Richard C L', 'Initials': 'RCL', 'LastName': 'Holt', 'Affiliation': ""Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Lachaux', 'Affiliation': 'Université Lyon 1 et Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Kelly', 'Affiliation': ""Birmingham Women's & Children's Hospital, Birmingham, UK.""}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Kazeem', 'Affiliation': 'Astellas Pharma Europe Ltd, Chertsey, UK.'}, {'ForeName': 'Nasrullah', 'Initials': 'N', 'LastName': 'Undre', 'Affiliation': 'Astellas Pharma Europe Ltd, Chertsey, UK.'}]",Clinical transplantation,['10.1111/ctr.13698']
167,31568698,"Whey protein isolate supplementation improves body composition, muscle strength, and treatment tolerance in malnourished advanced cancer patients undergoing chemotherapy.","In recent years, whey proteins (WP) have attracted increasing attention in health and disease for their bioactive functions. The aim of this study was to evaluate the benefit of WP isolate (WPI) supplementation in addition to nutritional counseling in malnourished advanced cancer patients undergoing chemotherapy (CT). In a single-center, randomized, pragmatic, and parallel-group controlled trial (ClinicalTrials.gov: NCT02065726), 166 malnourished advanced cancer patients with mixed tumor entities candidate to or undergoing CT were randomly assigned to receive nutritional counseling with (N = 82) or without (N = 84) WPI supplementation (20 g/d) for 3 months. The primary endpoint was the change in phase angle (PhA). Secondary endpoints included changes in standardized PhA (SPA), fat-free mass index (FFMI), body weight, muscle strength, and CT toxicity (CTCAE 4.0 events). In patients with the primary endpoint assessed (modified intention-to-treat population), counseling plus WPI (N = 66) resulted in improved PhA compared to nutritional counseling alone (N = 69): mean difference, 0.48° (95% CI, 0.05 to 0.90) (P = .027). WPI supplementation also resulted in improved SPA (P = .021), FFMI (P = .041), body weight (P = .023), muscle strength (P < .001), and in a reduced risk of CT toxicity (risk difference, -9.8% [95% CI, -16.9 to -2.6]; P = .009), particularly of severe (grade ≥ 3) events (risk difference, -30.4% [95% CI, -44.4 to -16.5]; P = .001). In malnourished advanced cancer patients undergoing CT, receiving nutritional counseling, a 3-month supplementation with WPI resulted in improved body composition, muscle strength, body weight, and reduced CT toxicity. Further trials, aimed at verifying the efficacy of this nutritional intervention on mid- and long-term primary clinical endpoints in newly diagnosed specific cancer types, are warranted.",2019,"WPI supplementation also resulted in improved SPA (P = .021), FFMI (P = .041), body weight (P = .023), muscle strength (P < .001), and in a reduced risk of CT toxicity (risk difference, -9.8% [95% CI, -16.9 to -2.6]; P = .009), particularly of severe (grade ≥ ","['malnourished advanced cancer patients undergoing', 'malnourished advanced cancer patients undergoing chemotherapy (CT', '166 malnourished advanced cancer patients with mixed tumor entities candidate to or undergoing CT', 'malnourished advanced cancer patients undergoing chemotherapy', 'newly diagnosed specific cancer types']","['WP isolate (WPI) supplementation', 'nutritional counseling with (N\xa0=\xa082) or without (N\xa0=\xa084) WPI supplementation', 'nutritional intervention', 'CT, receiving nutritional counseling', 'Whey protein isolate supplementation']","['FFMI', 'change in phase angle (PhA', 'SPA', 'modified intention-to-treat population), counseling plus WPI', 'body composition, muscle strength, body weight, and reduced CT toxicity', 'body weight', 'body composition, muscle strength, and treatment tolerance', 'changes in standardized PhA (SPA), fat-free mass index (FFMI), body weight, muscle strength, and CT toxicity (CTCAE 4.0 events', 'muscle strength', 'risk of CT toxicity']","[{'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0026277', 'cui_str': 'Syringoma, Chondroid'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.127147,"WPI supplementation also resulted in improved SPA (P = .021), FFMI (P = .041), body weight (P = .023), muscle strength (P < .001), and in a reduced risk of CT toxicity (risk difference, -9.8% [95% CI, -16.9 to -2.6]; P = .009), particularly of severe (grade ≥ ","[{'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Cereda', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Turri', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Klersy', 'Affiliation': 'Biometry and Clinical Epidemiology Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cappello', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrari', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Andrea Riccardo', 'Initials': 'AR', 'LastName': 'Filippi', 'Affiliation': 'Radiation Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Brugnatelli', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Marilisa', 'Initials': 'M', 'LastName': 'Caraccia', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Chiellino', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Borioli', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Monaco', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Giulia Maria', 'Initials': 'GM', 'LastName': 'Stella', 'Affiliation': 'Unit of Respiratory System Diseases, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Arcaini', 'Affiliation': 'Division of Hematology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Benazzo', 'Affiliation': 'Department of Otolaryngology, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Grugnetti', 'Affiliation': 'Nursing Technical and Rehabilitation Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pedrazzoli', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Caccialanza', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}]",Cancer medicine,['10.1002/cam4.2517']
168,31442303,"Randomized trial of weight loss in primary breast cancer: Impact on body composition, circulating biomarkers and tumor characteristics.","Obesity adversely impacts overall and cancer-specific survival among breast cancer patients. Preclinical studies demonstrate negative energy balance inhibits cancer progression; however, feasibility and effects in patients are unknown. A two-arm, single-blinded, randomized controlled weight-loss trial was undertaken presurgery among 32 overweight/obese, Stage 0-II breast cancer patients. The attention control arm (AC) received basic nutritional counseling and upper-body progressive resistance training whereas the weight loss intervention (WLI) arm received identical guidance, plus counseling on caloric restriction and aerobic exercise to promote 0.68-0.92 kg/week weight loss. Anthropometrics, body composition, blood and survey data were collected at baseline and presurgery ∼30 days later. Tumor markers (e.g., Ki67) and gene expression were assessed on biopsy and surgical specimens; sera were analyzed for cytokines, growth and metabolic factors. Significant WLI vs. AC differences were seen in baseline-to-follow-up changes in weight (-3.62 vs. -0.52 kg), %body fat (-1.3 vs. 0%), moderate-to-vigorous physical activity (+224 vs. +115 min/week), caloric density (-0.3 vs. 0 kcal/g), serum leptin (-12.3 vs. -4.0 ng/dl) and upregulation of tumor PI3Kinase signaling and cell cycle-apoptosis related genes (CC-ARG; all p-values <0.05). Cytolytic CD56 dim  NK cell expression was positively associated with weight loss; CC-ARG increased with physical activity. Increased tumor (nuclear) TNFα and IL-1β, CX3CL1 and CXCL1 gene expression was observed in the WLI. Tumor Ki67 did not differ between arms. Feasibility benchmarks included 80% accrual, 100% retention, no adverse effects and excellent adherence. Short-term weight loss interventions are feasible; however, mixed effects on tumor biology suggest unclear benefit to presurgical caloric restriction, but possible benefits of physical activity.",2020,Cytolytic CD56 dim  NK cell expression was positively associated with weight loss; CC-ARG increased with physical activity.,"['breast cancer patients', '32 overweight/obese, stage 0-II', 'Primary Breast Cancer']","['basic nutritional counseling and upper-body progressive resistance training whereas the weight loss intervention (WLI) arm received identical guidance, plus counseling on caloric restriction and aerobic exercise']","['Obesity adversely impacts overall and cancer-specific survival', 'weight loss; CC-ARG', 'adverse effects, and excellent adherence', 'moderate-to-vigorous physical activity', 'CX3CL1, and CXCL1 gene expression', 'Tumor Ki67', 'caloric density', 'weight ', 'Increased tumor(nuclear) TNFα and IL-1β', 'Tumor markers (e.g., Ki67) and gene expression', 'Cytolytic CD56 dim  NK cell expression', 'serum leptin', 'body fat', 'Anthropometrics, body composition, blood, and survey data']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441763', 'cui_str': 'Stage 0 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005768'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.0244253,Cytolytic CD56 dim  NK cell expression was positively associated with weight loss; CC-ARG increased with physical activity.,"[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'Laura Q', 'Initials': 'LQ', 'LastName': 'Rogers', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Justin T', 'Initials': 'JT', 'LastName': 'Gibson', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'Shuko', 'Initials': 'S', 'LastName': 'Harada', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Frugé', 'Affiliation': 'Auburn University, Auburn, AL.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Oster', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Grizzle', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Lyse A', 'Initials': 'LA', 'LastName': 'Norian', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'Eddy S', 'Initials': 'ES', 'LastName': 'Yang', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Della Manna', 'Affiliation': 'Department of Radiation Oncology, UAB, Birmingham, AL.'}, {'ForeName': 'Lee W', 'Initials': 'LW', 'LastName': 'Jones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Azrad', 'Affiliation': 'Department of Human Nutrition, Tuscaloosa, AL.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Krontiras', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}]",International journal of cancer,['10.1002/ijc.32637']
169,31173645,"Effects of CYP3A inhibitors on the pharmacokinetics of quizartinib, a potent and selective FLT3 inhibitor, and its active metabolite.","AIMS


Quizartinib is an oral, highly potent and selective next-generation FMS-like tyrosine kinase 3 (FLT3) inhibitor under investigation in patients with FLT3-internal tandem duplication-mutated acute myeloid leukaemia. This drug-drug interaction study assessed the pharmacokinetics (PK) of quizartinib when coadministered with strong or moderate cytochrome P450 3A (CYP3A) inhibitors.
METHODS


In this parallel-group study, subjects were randomised to receive: (i) quizartinib + ketoconazole; (ii) quizartinib + fluconazole; or (iii) quizartinib alone. On Days 1-28, subjects received ketoconazole 200 mg or fluconazole 200 mg twice daily, and on Day 8, all subjects received a single 30-mg quizartinib dose. Blood samples were collected for PK analyses, steady-state PK parameters were simulated by superpositioning, and safety was assessed.
RESULTS


Ninety-three healthy subjects were randomised; 86 completed the study. When administered with ketoconazole, geometric mean ratios (90% confidence interval) for quizartinib maximum observed plasma concentration (C max  ) and area under the plasma concentration-time curve (AUC) from time 0 extrapolated to infinity were 117% (105%, 130%) and 194% (169%, 223%), respectively, vs quizartinib alone. Steady-state PK simulation demonstrated ~2-fold increase of both steady-state C max  and AUC from time 0 to the end of the dosing interval when quizartinib was administered with ketoconazole due to accumulation of quizartinib at steady state. When administered with fluconazole, geometric mean ratios (90% confidence interval) for quizartinib C max  and AUC from time 0 extrapolated to infinity were 111% (100%, 124%) and 120% (104%, 138%), respectively, vs quizartinib alone. Overall, 5.4% of subjects experienced quizartinib-related adverse events; no serious adverse events or deaths occurred.
CONCLUSIONS


These results suggest reducing the dose of quizartinib when coadministered with a strong CYP3A inhibitor, but not with a moderate or weak CYP3A inhibitor. This dose reduction was implemented in phase 3 evaluation of quizartinib.",2019,"Overall, 5.4% of subjects experienced quizartinib-related adverse events (AEs); no serious AEs or deaths occurred.
","['patients with FLT3-internal tandem duplication (ITD)-mutated acute myeloid leukaemia (AML', 'Ninety-three healthy subjects were randomised; 86 completed the study']","['ketoconazole', 'quizartinib+ketoconazole, (2) quizartinib+fluconazole, or (3) quizartinib alone', 'CYP3A inhibitors', 'ketoconazole 200 mg or fluconazole', 'fluconazole']","['quizartinib C max  and AUC inf', 'quizartinib-related adverse events (AEs); no serious AEs or deaths', 'geometric mean ratios']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication (finding)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C2980091', 'cui_str': 'AC220 compound'}, {'cui': 'C3850056', 'cui_str': 'CYP3A Inhibitors'}, {'cui': 'C0992485', 'cui_str': 'Ketoconazole 200 MG'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C2980091', 'cui_str': 'AC220 compound'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",93.0,0.0292452,"Overall, 5.4% of subjects experienced quizartinib-related adverse events (AEs); no serious AEs or deaths occurred.
","[{'ForeName': 'Jianke', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Daiichi Sankyo, Inc, San Diego, CA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kankam', 'Affiliation': 'Vince & Associates Clinical Research, Overland Park, KS, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Trone', 'Affiliation': 'Daiichi Sankyo, Inc, San Diego, CA, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Gammon', 'Affiliation': 'Daiichi Sankyo, Inc, San Diego, CA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14022']
170,31701485,Assessing the Long-Term Effectiveness of Cladribine vs. Placebo in the Relapsing-Remitting Multiple Sclerosis CLARITY Randomized Controlled Trial and CLARITY Extension Using Treatment Switching Adjustment Methods.,"OBJECTIVES


Treatment switching adjustment methods are often used to adjust for switching in oncology randomized controlled trials (RCTs). In this exploratory analysis, we apply these methods to adjust for treatment changes in the setting of an RCT followed by an extension study in relapsing-remitting multiple sclerosis.
METHODS


The CLARITY trial evaluated cladribine tablets versus placebo over 96 weeks. In the 96-week CLARITY Extension, patients who received placebo in CLARITY received cladribine tablets; patients who received cladribine tablets in CLARITY were re-randomized to placebo or cladribine tablets. End points were time to first qualifying relapse (FQR) and time to 3- and 6-month confirmed disability progression (3mCDP, 6mCDP). We aimed to compare the effectiveness of cladribine tablets with placebo over CLARITY and the extension. The rank-preserving structural failure time model (RPSFTM) and iterative parameter estimation (IPE) were used to estimate what would have happened if patients had received placebo in CLARITY and the extension versus patients that received cladribine tablets and switched to placebo. To gauge whether treatment effect waned after the 96 weeks of CLARITY, we compared hazard ratios (HRs) from the adjustment analysis with HRs from CLARITY.
RESULTS


The RPSFTM resulted in an HR of 0.48 [95% confidence interval (CI) 0.36-0.62] for FQR, 0.62 (95% CI 0.46-0.84) for 3mCDP and 0.62 (95% CI 0.44-0.88) for 6mCDP. IPE algorithm results were similar. CLARITY HRs were 0.44 (95% CI 0.34-0.58), 0.60 (95% CI 0.41-0.87) and 0.58 (95% CI 0.40-0.83) for FQR, 3mCDP and 6mCDP, respectively.
CONCLUSIONS


Treatment switching adjustment methods are applicable in non-oncology settings. Adjusted CLARITY plus CLARITY Extension HRs were similar to the CLARITY HRs, demonstrating significant treatment benefits associated with cladribine tablets versus placebo.
FUNDING


EMD Serono, Inc. (a business of Merck KGaA, Darmstadt, Germany).",2020,The rank-preserving structural failure time model (RPSFTM) and iterative parameter estimation (IPE) were used to estimate what would have happened if patients had received placebo in CLARITY and the extension versus patients that received cladribine tablets and switched to placebo.,[],"['placebo or cladribine tablets', 'Cladribine vs. Placebo', 'cladribine tablets', 'placebo', 'cladribine', 'cladribine tablets with placebo', 'cladribine tablets versus placebo']","['time to first qualifying relapse (FQR) and time to 3- and 6-month confirmed disability progression (3mCDP, 6mCDP']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.498083,The rank-preserving structural failure time model (RPSFTM) and iterative parameter estimation (IPE) were used to estimate what would have happened if patients had received placebo in CLARITY and the extension versus patients that received cladribine tablets and switched to placebo.,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bell Gorrod', 'Affiliation': 'School for Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK. helen.bellgorrod@sheffield.ac.uk.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Latimer', 'Affiliation': 'School for Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Damian', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hettle', 'Affiliation': 'PAREXEL International, London, UK.'}, {'ForeName': 'Gerard T', 'Initials': 'GT', 'LastName': 'Harty', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA.'}, {'ForeName': 'Schiffon L', 'Initials': 'SL', 'LastName': 'Wong', 'Affiliation': 'EMD Serono, Inc., Billerica, MA, USA.'}]",Advances in therapy,['10.1007/s12325-019-01140-z']
171,31758517,Influence of Direct Thrombin Inhibitor and Low Molecular Weight Heparin on Platelet Function in Patients with Coronary Artery Disease: A Prospective Interventional Trial.,"INTRODUCTION


The interaction between anticoagulants and platelet function is complex. Previous publications showed mixed results regarding the role of heparins in platelet aggregation. On the other hand, the direct thrombin inhibitor (DTI) dabigatran might enhance the risk of myocardial infarction in patients with atrial fibrillation, which could be related to increased platelet aggregability.
METHODS


This was a prospective, interventional study of patients with chronic coronary artery disease (CAD) taking low-dose aspirin. The objective of the current study was to compare the effects of dabigatran versus enoxaparin on platelet aggregability. Subjects initially were on orally administered dabigatran for 5 days followed by subcutaneously administered enoxaparin after a 30-day washout period. Platelet function was assessed at baseline and after each intervention by multiple electrode aggregometry (MEA-ASPI) (primary endpoint), serum thromboxane B2 (TXB2), VerifyNow Aspirin™, and coagulation tests (secondary endpoints).
RESULTS


Compared to baseline MEA-ASPI values, dabigatran increased platelet aggregation while enoxaparin decreased platelet aggregation (+ 5 U ± 24.1 vs - 6 U ± 22.2, respectively, p = 0.012). The TXB2 assay showed the same pattern (+ 2 pg/ml for dabigatran vs - 13 pg/ml for enoxaparin, p = 0.011). None of the additional tests showed significant differences between the groups. Individually, compared to baseline TXB2 results, enoxaparin significantly decreased platelet activation [33 (16.5-95) pg/mL vs 20 (10-52) pg/mL, respectively, p = 0.026], but no significant differences were observed with dabigatran.
CONCLUSIONS


DTI and anti-Xa drugs exert opposite effects on platelet function. A significant decrease in platelet activation through COX1 (also known as prostaglandin G/H synthase 1) was observed with enoxaparin, but no significant differences in platelet function were observed with dabigatran.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02389582.",2020,"Compared to baseline MEA-ASPI values, dabigatran increased platelet aggregation while enoxaparin decreased platelet aggregation (+ 5 U ± 24.1 vs - 6 U ± 22.2, respectively, p = 0.012).","['patients with atrial fibrillation', 'Patients with Coronary Artery Disease', 'patients with chronic coronary artery disease (CAD) taking low-dose']","['dabigatran versus enoxaparin', 'Direct Thrombin Inhibitor and Low Molecular Weight Heparin', 'enoxaparin', 'aspirin', 'direct thrombin inhibitor (DTI) dabigatran']","['Platelet function', 'platelet function', 'platelet aggregability', 'platelet activation', 'Platelet Function', 'serum thromboxane B2 (TXB2), VerifyNow Aspirin™, and coagulation tests (secondary endpoints', 'platelet activation through COX1', 'platelet aggregation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0003440', 'cui_str': 'Direct Thrombin Inhibitors'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040059', 'cui_str': 'Thromboxa-5,13-dien-1-oic acid, 9,11,15-trihydroxy-, (5Z,9alpha,13E,15S)-'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1504378', 'cui_str': 'Coagulation test'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}]",,0.0393859,"Compared to baseline MEA-ASPI values, dabigatran increased platelet aggregation while enoxaparin decreased platelet aggregation (+ 5 U ± 24.1 vs - 6 U ± 22.2, respectively, p = 0.012).","[{'ForeName': 'Flávia B B', 'Initials': 'FBB', 'LastName': 'Arantes', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fernando R', 'Initials': 'FR', 'LastName': 'Menezes', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Franci', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carlos J D G', 'Initials': 'CJDG', 'LastName': 'Barbosa', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Talia F', 'Initials': 'TF', 'LastName': 'Dalçoquio', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carlos A K', 'Initials': 'CAK', 'LastName': 'Nakashima', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciano M', 'Initials': 'LM', 'LastName': 'Baracioli', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Quintiliano S S', 'Initials': 'QSS', 'LastName': 'Nomelini', 'Affiliation': 'Federal University of Uberlândia, Uberlândia, Brazil.'}, {'ForeName': 'José A F', 'Initials': 'JAF', 'LastName': 'Ramires', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Kalil Filho', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil. corjnicolau@incor.usp.br.'}]",Advances in therapy,['10.1007/s12325-019-01153-8']
172,31215676,Reduced bioavailability of oral amoxicillin tablets compared to suspensions in Roux-en-Y gastric bypass bariatric subjects.,"AIMS


To evaluate the relative bioavailability of oral amoxicillin (AMX) tablets in comparison to AMX suspension in Roux-en-Y gastric bypass bariatric subjects.
METHODS


A randomized, double-blind, cross-over study was performed on the bioavailability of oral AMX tablets and suspension in Roux-en-Y gastric bypass subjects operated at least 3 months previously . Doses of 875 mg of the AMX tablet or 800 mg of the AMX suspension were given to all the subjects, allowing a washout of 7 days between the periods. Blood samples were collected at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6 and 8 hours after drug administration and the AMX levels were quantified by liquid chromatography coupled with triple quadrupole tandem mass spectrometry. The pharmacokinetic parameters were calculated by noncompartmental analysis, normalized to an 875 mg dose and the bioavailability of the AMX from the tablets was compared to that from the suspension formulation.
RESULTS


Twenty subjects aged 42.65 ± 7.21 years and with a body mass index of 29.88 ± 4.36 kg/m 2  were enrolled in the study. The maximum AMX plasma concentration of the tablets and the suspension (normalized to 875 mg) were 7.42 ± 2.99 mg/L and 8.73 ± 3.26 mg/L (90% confidence interval of 70.71-99.11), and the total area under the curve from time zero to infinity were 23.10 ± 7.41 mg.h/L and 27.59 ± 8.32 mg.h/L (90% confidence interval of 71.25-97.32), respectively.
CONCLUSION


The tablets presented a lower bioavailability than the suspension formulation and the total absorbed amount of AMX in these subjects was lower in comparison to the standard AMX absorption rates in nonbariatric subjects, regardless of the formulation.",2019,"The tablets presented a lower bioavailability than the suspension formulation and the total absorbed amount of AMX in these subjects was lower in comparison to the standard AMX absorption rates in non-bariatric subjects, regardless of the formulation.","['Roux-en-Y gastric bypass (RYGB) bariatric subjects', 'RYGB subjects at least 3 months previously operated was performed', 'RYGB bariatric subjects', 'Twenty subjects aged 42.65 ± 7.21 years old and with a body mass index (BMI) of 29.88 ± 4.36 kg/m 2  were enrolled in the study']","['AMX', 'AMX suspension', 'amoxicillin (AMX) tablets', 'amoxicillin tablets']","['AMX levels', 'bioavailability of the AMX', 'Blood samples', 'Reduced bioavailability', 'standard AMX absorption rates']","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]",20.0,0.0341686,"The tablets presented a lower bioavailability than the suspension formulation and the total absorbed amount of AMX in these subjects was lower in comparison to the standard AMX absorption rates in non-bariatric subjects, regardless of the formulation.","[{'ForeName': 'Maiara Camotti', 'Initials': 'MC', 'LastName': 'Montanha', 'Affiliation': 'Postgraduate Program in Biosciences and Physiopathology (PBF), Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Thiago Ferreira', 'Initials': 'TF', 'LastName': 'Dos Santos Magon', 'Affiliation': 'Postgraduate Program in Food Science (PPC), Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Conrado', 'Initials': 'C', 'LastName': 'de Souza Alcantara', 'Affiliation': 'Postgraduate Program in Biosciences and Physiopathology (PBF), Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Caroline Ferraz', 'Initials': 'CF', 'LastName': 'Simões', 'Affiliation': 'Postgraduate Program in Physical Education, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Sandra Regina Bin', 'Initials': 'SRB', 'LastName': 'Silva', 'Affiliation': 'Clinical Research Centre and Bioequivalence Studies, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Cristina Megumi', 'Initials': 'CM', 'LastName': 'Kuroda', 'Affiliation': 'Clinical Research Centre and Bioequivalence Studies, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Sérgio Seiji', 'Initials': 'SS', 'LastName': 'Yamada', 'Affiliation': 'Clinical Research Centre and Bioequivalence Studies, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Lucas Eduardo Savóia', 'Initials': 'LES', 'LastName': 'de Oliveira', 'Affiliation': 'Clinical Research Centre and Bioequivalence Studies, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Daoud', 'Initials': 'D', 'LastName': 'Nasser', 'Affiliation': 'Clinical Research Centre and Bioequivalence Studies, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Nelson Nardo', 'Initials': 'NN', 'LastName': 'Junior', 'Affiliation': 'Department of Physical Education, Centre for Multiprofessional Studies of Obesity (NEMO), Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Josmar', 'Initials': 'J', 'LastName': 'Mazucheli', 'Affiliation': 'Department of Statistics, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Diniz', 'Affiliation': 'Department of Pharmacy, Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}, {'ForeName': 'Paulo Jorge Pereira Alves', 'Initials': 'PJPA', 'LastName': 'Paixão', 'Affiliation': 'Department of Pharmacy, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Elza', 'Initials': 'E', 'LastName': 'Kimura', 'Affiliation': 'Postgraduate Program in Biosciences and Physiopathology (PBF), Universidade Estadual de Maringá, Maringá, Paraná, Brazil.'}]",British journal of clinical pharmacology,['10.1111/bcp.14023']
173,32112126,Slightly better pain relief but more frequently motor blockade with combined nerve block analgesia compared to continuous intraarticular analgesia after total knee arthroplasty.,"PURPOSE


Pain management after total knee arthroplasty (TKA) is still under debate. Continuous peripheral nerve blocks (PNB) can provide long pain relief but impair muscle function. Continuous intraarticular analgesia could result in longer pain relief than local infiltration analgesia without negative effects on muscle function. This study investigated the efficacy of pain control between PNB's and continuous intraarticular analgesia after TKA.
METHODS


A prospective randomized study on 140 patients undergoing TKA was performed. Patients received either a combination of continuous femoral nerve block, continuous sciatic nerve block and single-shot obturator nerve block (group R) or a local infiltration analgesia and a continuous intraarticular catheter with ropivacaine (group L). Primary outcome was pain measured on a numerical rating scale. Knee function, patient-reported outcome (PRO) and adverse events were assessed until 1 year after surgery.
RESULTS


Pain at rest was lower in group R on the day of surgery (mean NRS 3.0 vs. 4.2) and the morning of postoperative day 1 (mean NRS 3.4 vs. 4.4). Motor blockade longer than postoperative day 3 occurred more often in group R compared to group L (15.3% vs. 1.5%). Pain levels, PRO and satisfaction 3-month and 1-year after surgery were similar.
CONCLUSION


Continuous PNB's were slightly more effective in the first 24 h after surgery but were associated more often with motor blockade which should be avoided. It must be balanced if the small amount of better pain relief immediately after surgery justifies the risks associated with motor blockade following PNB's.
LEVEL OF EVIDENCE


I.",2020,Motor blockade longer than postoperative day 3 occurred more often in group R compared to group L (15.3% vs. 1.5%).,"['total knee arthroplasty (TKA', '140 patients undergoing']","['Continuous peripheral nerve blocks (PNB', 'combination of continuous femoral nerve block, continuous sciatic nerve block and single-shot obturator nerve block (group R) or a local infiltration analgesia and a continuous intraarticular catheter with ropivacaine', 'TKA']","['Pain at rest', 'Pain levels, PRO and satisfaction 3-month and 1-year', 'pain measured on a numerical rating scale', 'pain relief', 'longer pain relief', 'Knee function, patient-reported outcome (PRO) and adverse events']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia (procedure)'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0394741', 'cui_str': 'Local anesthetic obturator nerve block (procedure)'}, {'cui': 'C0441852', 'cui_str': 'Group R (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",140.0,0.130247,Motor blockade longer than postoperative day 3 occurred more often in group R compared to group L (15.3% vs. 1.5%).,"[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Lützner', 'Affiliation': 'Department for Orthopaedic and Trauma Surgery, University Medicine Carl Gustav Carus, Fetscherstr. 74, 01307, Dresden, Germany. joerg.luetzner@uniklinikum-dresden.de.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gehring', 'Affiliation': 'Department for Orthopaedic and Trauma Surgery, University Medicine Carl Gustav Carus, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Beyer', 'Affiliation': 'Department for Orthopaedic and Trauma Surgery, University Medicine Carl Gustav Carus, Fetscherstr. 74, 01307, Dresden, Germany.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05843-2']
174,31269890,"The Effect of Vitamin D3 Supplementation on Serum BDNF, Dopamine, and Serotonin in Children with Attention-Deficit/Hyperactivity Disorder.","BACKGROUND & OBJECTIVE


Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most common psychiatric disorders in childhood. The exact etiology of this disease is unknown, but it is believed to be related to the disorder of catecholaminergic and serotonergic systems. Also, serum vitamin D levels in patients with ADHD is lower. Several studies have also shown the effect of vitamin D on the synthesis pathways of dopamine, serotonin, and a number of neurotrophic factors. Therefore, this study aimed to investigate the effect of vitamin D3 supplementation on serum levels of Brain-Derived Neurotrophic Factor (BDNF), dopamine, and serotonin in school-aged children with ADHD.
METHODS


Eighty-six children with ADHD were divided into two groups, based on randomized permuted blocks. Patients received 2000 IU vitamin D/day or a placebo for 12 weeks. Serum levels of BDNF, dopamine, serotonin, and 25-hydroxyvitamin D [25(OH)D] were measured at baseline and at the end of the study.
RESULTS


Serum levels of 25(OH)D and dopamine significantly increased in the vitamin D group, compared to the placebo group (p < 0.05). However, serum BDNF and serotonin levels did not change significantly.
CONCLUSION


Vitamin D3 supplementation in children with ADHD can increase serum dopamine levels, but further studies are needed to determine the effects of vitamin D on neurotrophic factors and serotonin.",2019,"RESULTS


Serum levels of 25(OH)D and dopamine significantly increased in the vitamin D group, compared to the placebo group (p < 0.05).","['Children with Attention-Deficit/Hyperactivity Disorder', 'school-aged children with ADHD', 'Eighty-six children with ADHD', 'patients with ADHD', 'children with ADHD']","['vitamin D', 'placebo', 'Vitamin D3 Supplementation', 'Vitamin D3 supplementation', 'vitamin D3 supplementation', '2000 IU vitamin D/day or a placebo']","['Serum levels of BDNF, dopamine, serotonin and 25-hydroxyvitamin D [25(OH)D', 'serum levels of brain-derived neurotrophic factor (BDNF), dopamine and serotonin', 'serum BDNF and serotonin levels', 'serum vitamin D levels', 'Serum BDNF, Dopamine and Serotonin', 'Serum levels of 25(OH)D and dopamine']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}]",86.0,0.0867113,"RESULTS


Serum levels of 25(OH)D and dopamine significantly increased in the vitamin D group, compared to the placebo group (p < 0.05).","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Seyedi', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Gholami', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Samadi', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Djalali', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Effatpanah', 'Affiliation': 'Department of Geriatric Medicine, Ziaeian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Rezvan', 'Initials': 'R', 'LastName': 'Hashemi', 'Affiliation': 'Department of Geriatric Medicine, Ziaeian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Abdolahi', 'Affiliation': 'AmirAlam Hospital Complexes, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Chamari', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Niyaz Mohammadzadeh', 'Initials': 'NM', 'LastName': 'Honarvar', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}]",CNS & neurological disorders drug targets,['10.2174/1871527318666190703103709']
175,31240722,Effects of non-dispensing pharmacists integrated in general practice on medication-related hospitalisations.,"AIMS


To evaluate the effect of non-dispensing pharmacists (NDPs) integrated in general practice on medication-related hospitalisations, drug burden index and costs in patients at high risk of medication problems (being 65 years or older and using 5 or more chronic medications).
METHODS


This was a multicentre, nonrandomised, controlled intervention study with pre-post comparison (2013 vs June 2014 to May 2015) in 25 general practices in the Netherlands, comparing NDP-led care (intervention) with 2 current pharmaceutical care models (usual care and usual care plus). In the intervention group, 10 specially trained NDPs were employed in general practices to take integral responsibility for the pharmaceutical care. They provided a broad range of medication therapy management services both on patient level (e.g. clinical medication review) and practice level (e.g. quality improvement projects). In the control groups, pharmaceutical care was provided as usual by general practitioners and community pharmacists, or as usual plus, when pharmacists were additionally trained in performing medication reviews.
RESULTS


Overall, 822 medication-related hospitalisations were identified among 11 281 high-risk patients during the intervention period. After adjustment for clustering and potential confounders, the rate ratio of medication-related hospitalisations in the intervention group compared to usual care was 0.68 (95% confidence interval: 0.57-0.82) and 1.05 (95% confidence interval: 0.73-1.52) compared to usual care plus. No differences in drug burden index or costs were found.
CONCLUSIONS


In general practices with an integrated NDP, the rate of medication-related hospitalisations is lower compared to usual care. No differences with usual care plus were found.",2019,"In general practices with an integrated NDP, the rate of medication-related hospitalisations is lower compared to usual care.","['2013 versus June 2014 to May 2015) in 25 general practices in the Netherlands, comparing', 'patients at high risk of medication problems (being 65 years or older and using five or more chronic medications']","['NDP-led care (intervention) with two current pharmaceutical care models (usual care and usual care plus', 'non-dispensing pharmacists (NDPs', 'pre-post comparison']","['drug burden index or costs', 'rate ratio of medication-related hospitalisations']","[{'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1449618', 'cui_str': 'Pharmaceutical Care'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0285744', 'cui_str': 'NDPS'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",11281.0,0.0895108,"In general practices with an integrated NDP, the rate of medication-related hospitalisations is lower compared to usual care.","[{'ForeName': 'V M', 'Initials': 'VM', 'LastName': 'Sloeserwij', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'A C M', 'Initials': 'ACM', 'LastName': 'Hazen', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'D L M', 'Initials': 'DLM', 'LastName': 'Zwart', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Leendertse', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Poldervaart', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'de Bont', 'Affiliation': 'Erasmus School of Health Policy and Management, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'de Gier', 'Affiliation': 'Department of Pharmacotherapy, Epidemiology and Economics, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Bouvy', 'Affiliation': 'Department of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'de Wit', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14041']
176,31077432,Randomized study of individualized pharmacokinetically-guided dosing of paclitaxel compared with body-surface area dosing in Chinese patients with advanced non-small cell lung cancer.,"AIMS


This prospective, randomized study was initiated to assess the impact of pharmacokinetically (PK)-guided paclitaxel (PTX) dosing on toxicity and efficacy compared with body-surface area (BSA)-based dosing in Chinese non-small cell lung cancer patients.
METHODS


A total of 319 stage IIIB/IV non-small cell lung cancer patients receiving first-line chemotherapy were enrolled. Patients were randomized to receive 3-weekly carboplatin plus PTX at a starting dose of 175 mg/m 2  with subsequent PTX dosing based on either BSA or PK-guided dosing targeting time above a PTX plasma concentration of 0.05 μmol/L (PTX Tc > 0.05  ) between 26 and 31 hours. The primary safety endpoint was grade 4 haematological toxicity. The secondary endpoints were neuropathy, objective response rate, progression-free survival and overall survival.
RESULTS


In total, 275 (86%) patients completed ≥2 cycles of chemotherapy (140 in BSA arm and 135 in PK arm). In cycle 1, with the same PTX dose, average PTX Tc > 0.05  was 37 hours (range = 18-57 hours). Over cycles 2-4, patients in the PK arm had significantly lower average PTX doses and exposure compared with the BSA arm (128 vs 161 mg/m 2  , P < .0001 and 29 vs 35 hours, P < .0001). PK-guided dosing significantly reduced the cumulative incidence of grade 4 haematological toxicity (15% vs 24%, P = .004), grade 4 neutropenia (15% vs 23%, P = .009) and grade ≥ 2 neuropathy (8% vs 21%, P = .005). Objective response rate (32% vs 26%, P = .28) and overall survival (21.0 vs 24.0 months, P = .815) were similar in PK and BSA arms. Progression-free survival was slightly improved in PK arm (4.67 vs 4.17 months, P = .026).
CONCLUSION


PK-guided PTX dosing significantly reduced grade 4 haematological toxicities and grade ≥ 2 neuropathy without an adverse impact on clinical outcomes.",2019,"Progression-free survival was slightly improved in PK arm (4.67 vs 4.17 months, P = .026).
","['Chinese patients with advanced non-small cell lung cancer', 'Chinese non-small cell lung cancer patients', '319 stage IIIB/IV non-small cell lung cancer patients receiving first-line chemotherapy were enrolled']","['chemotherapy', 'carboplatin plus PTX', 'pharmacokinetically (PK)-guided paclitaxel (PTX', 'PK-guided PTX', 'individualized pharmacokinetically-guided dosing of paclitaxel', 'BSA', 'body-surface area (BSA)-based dosing']","['2 neuropathy', 'Progression-free survival', 'Objective response rate', 'grade 4 neutropenia', 'average PTX doses and exposure', 'neuropathy, objective response rate, progression-free survival and overall survival', 'grade 4 haematological toxicities and grade', 'cumulative incidence of grade 4 haematological toxicity', 'toxicity and efficacy', 'grade 4 haematological toxicity', 'overall survival']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",319.0,0.2541,"Progression-free survival was slightly improved in PK arm (4.67 vs 4.17 months, P = .026).
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huiwei', 'Initials': 'H', 'LastName': 'Qi', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Caicun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yunying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Saladax Biomedical, Inc., Bethlehem, PA, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Baburina', 'Affiliation': 'Saladax Biomedical, Inc., Bethlehem, PA, USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Courtney', 'Affiliation': 'Saladax Biomedical, Inc., Bethlehem, PA, USA.'}, {'ForeName': 'Salvatore J', 'Initials': 'SJ', 'LastName': 'Salamone', 'Affiliation': 'Saladax Biomedical, Inc., Bethlehem, PA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.13982']
177,31711300,Household Water Quality Testing and Information: Identifying Impacts on Health Outcomes and Sanitation- and Hygiene-Related Risk-Mitigating Behaviors.,"BACKGROUND


In 2014, a group of 512 households in multipurpose water systems and also relying on unimproved water, sanitation, and hygiene practices in the Greater Accra region of Ghana were randomly selected to participate in water quality self-testing and also receipt of information in the form of handouts on how to improve water quality.
OBJECTIVES AND RESEARCH DESIGN


Using a cluster-randomized controlled design, we study the health, sanitation, and hygiene behavior impacts of the household water quality testing and information experiment.
SUBJECTS


The study has three arms: (1) adult household members, (2) schoolgoing children, and (3) control group.
MEASURES


The study measures the effects on handwashing with soap, cleanliness of households, and prevalence of diarrhea and self-reported fever. We also address impacts on child health and nutrition outcomes, particularly diarrhea and anthropometric outcomes.
RESULTS


We show that there is high household willingness to participate in this intervention on water quality self-testing. About 7 months after households took part in the intervention, the study finds little impacts on health outcomes and on sanitation- and hygiene-related risk-mitigating behaviors, regardless of the intervention group, either schoolchildren or adult household members. Impacts (direction and extent) are rather homogeneous for most of the outcomes across treatment groups.
CONCLUSIONS


The study discusses the implications of the findings and also offers several explanations for the lack of transmission of impacts from the household water quality testing and information intervention on health outcomes and on sanitation and hygiene behaviors.",2019,"About 7 months after households took part in the intervention, the study finds little impacts on health outcomes and on sanitation- and hygiene-related risk-mitigating behaviors, regardless of the intervention group, either schoolchildren or adult household members.","['adult household members, (2) schoolgoing children, and (3) control group', '512 households in multipurpose water systems and also relying on unimproved water, sanitation, and hygiene practices in the Greater Accra region of Ghana']",[],"['child health and nutrition outcomes, particularly diarrhea and anthropometric outcomes', 'handwashing with soap, cleanliness of households, and prevalence of diarrhea and self-reported fever']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]",[],"[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}]",,0.0231326,"About 7 months after households took part in the intervention, the study finds little impacts on health outcomes and on sanitation- and hygiene-related risk-mitigating behaviors, regardless of the intervention group, either schoolchildren or adult household members.","[{'ForeName': 'Charles Yaw', 'Initials': 'CY', 'LastName': 'Okyere', 'Affiliation': 'Department of Agricultural Economics and Agribusiness, College of Basic and Applied Sciences, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Evita Hanie', 'Initials': 'EH', 'LastName': 'Pangaribowo', 'Affiliation': 'Faculty of Geography, Department of Environmental Geography, Gadjah Mada University, Yogyakarta, Indonesia.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Gerber', 'Affiliation': 'Center for Development Research (ZEF), University of Bonn, Germany.'}]",Evaluation review,['10.1177/0193841X19885204']
178,31218738,Appropriateness of prescription of oral anticoagulant therapy in acutely hospitalized older people with atrial fibrillation. Secondary analysis of the SIM-AF cluster randomized clinical trial.,"AIMS


To assess the appropriateness of oral anticoagulant (OAC) prescription and its associated factors in acutely hospitalized elderly patients.
METHODS


Data were obtained from the prospective phase of SIM-AF (SIMulation-based technologies to improve the appropriate use of oral anticoagulants in hospitalized elderly patients with Atrial Fibrillation) randomized controlled trial, aimed to test whether an educational intervention improved OAC prescription, compared to current clinical practice, in internal medicine wards. In this secondary analysis, appropriateness of OAC prescription was assessed at hospital admission and discharge.
RESULTS


For 246 patients, no significant differences were found between arms (odds ratio 1.38, 95% confidence interval [CI] 0.84-2.28) in terms of appropriateness of OAC prescription. Globally, 92 patients (37.4%, 95% CI = 31.6-43.6%) were inappropriately prescribed or not prescribed at hospital discharge. Among 51 patients inappropriately prescribed, 82% showed errors on dosage, being mainly under-dosed (n = 29, 56.9%), and among 41 inappropriately not prescribed, 98% were taking an antiplatelet drug. Factors independently associated with a lower probability of appropriateness at discharge were those related to a higher risk of bleeding (older age, higher levels of aspartate aminotransferase, history of falls, alcohol consumption) and antiplatelet prescription at admission. The prescription of OACs at admission was the strongest predictor of appropriateness at discharge (odds ratio = 7.43, 95% CI = 4.04-13.73).
CONCLUSIONS


A high proportion of hospitalized older patients with AF remains inappropriately prescribed or nonprescribed with OACs. The management of these patients at hospital admission is the strongest predictor of prescription appropriateness at discharge.",2019,"The prescription of OACs at admission was the strongest predictor of appropriateness at discharge (OR= 7.43, 95% CI= 4.04 - 13.73).
","['acutely hospitalized elderly patients', '51 patients inappropriately prescribed, 82% showed errors on dosage, being mainly under-dosed (N=29, 56.9%), and among 41 inappropriately not prescribed, 98% were taking an antiplatelet drug', '246 patients', 'hospitalized elderly patients with Atrial Fibrillation', 'hospitalized older patients with AF remains inappropriately prescribed or non prescribed with OACs', 'acutely hospitalized older people with atrial fibrillation']","['oral anticoagulant therapy', 'educational intervention improved OAC prescription', 'SIM-AF (SIM ulation-based technologies']","['aspartate aminotransferase, history of falls, alcohol consumption) and antiplatelet prescription at admission']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet Agents'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",246.0,0.12033,"The prescription of OACs at admission was the strongest predictor of appropriateness at discharge (OR= 7.43, 95% CI= 4.04 - 13.73).
","[{'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Antoniazzi', 'Affiliation': ""Scientific Direction, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Ardoino', 'Affiliation': 'Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Proietti', 'Affiliation': 'Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Monzani', 'Affiliation': ""Department of Internal Medicine, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Pier Mannuccio', 'Initials': 'PM', 'LastName': 'Mannucci', 'Affiliation': ""Scientific Direction, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Nobili', 'Affiliation': 'Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Franchi', 'Affiliation': 'Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of clinical pharmacology,['10.1111/bcp.14029']
179,31741283,Topical Low Dose Preservative-Free Hydrocortisone Reduces Signs and Symptoms in Patients with Chronic Dry Eye: A Randomized Clinical Trial.,"PURPOSE


Dry eye disease (DED) is a highly prevalent ocular condition with a significant burden on affected patients. Regardless of the underlying etiology, DED is associated with increased ocular surface inflammation. We investigated the safety and efficacy of a short-term treatment with topical low dose hydrocortisone in patients with chronic DED and ocular surface inflammation.
METHODS


A total of 60 patients (mean age 51 ± 14 years) with chronic DED and conjunctival hyperemia greater than grade 2 on the Efron scale were included. Patients were randomized to receive either preservative-free hydrocortisone 0.335% (Softacort, Laboratories Thea, France) for 12 days four times daily followed by 2 days twice daily instillation (intense treatment group) or 8 days three times daily followed by 3 days twice daily treatment (standard treatment group). Ocular redness was assessed at baseline, day 14, and day 28. Measurement of intraocular pressure (IOP) and clinical tests to assess signs and symptoms of DED were performed.
RESULTS


Conjunctival hyperemia and Ocular Surface Disease Index (OSDI) significantly decreased in both treatment groups (p < 0.001 each) after hydrocortisone treatment. A significant increase in tear film thickness was seen 4 weeks after treatment start (p = 0.03 and p = 0.04, respectively). IOP did not change in either of the two treatment groups (p = 0.45).
CONCLUSION


Treatment with low dose hydrocortisone 0.335% reduced ocular inflammation and decreased OSDI score. No change in IOP was observed in either of the two treatment schedules. Because of its good safety profile, low dose hydrocortisone may be an interesting alternative to standard corticosteroid treatment in DED.
FUNDING


Laboratories Thea.
TRIAL REGISTRATION


Clinicaltrials.gov registry: NCT03907865.",2020,"A significant increase in tear film thickness was seen 4 weeks after treatment start (p = 0.03 and p = 0.04, respectively).","['patients with chronic DED and ocular surface inflammation', 'Patients with Chronic Dry Eye', '60 patients (mean age 51\u2009±\u200914\xa0years) with chronic DED and conjunctival hyperemia greater than grade\xa02 on the Efron scale were included']","['Topical Low Dose Preservative-Free Hydrocortisone', 'topical low dose hydrocortisone', 'hydrocortisone', 'preservative-free hydrocortisone']","['Measurement of intraocular pressure (IOP', 'IOP', 'Conjunctival hyperemia and Ocular Surface Disease Index (OSDI', 'ocular inflammation and decreased OSDI score', 'tear film thickness', 'Ocular redness', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.185428,"A significant increase in tear film thickness was seen 4 weeks after treatment start (p = 0.03 and p = 0.04, respectively).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kallab', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Szegedi', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Hommer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Stegmann', 'Affiliation': 'Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Semira', 'Initials': 'S', 'LastName': 'Kaya', 'Affiliation': 'Department of Ophthalmology, Hietzing Hospital, Vienna, Austria.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Werkmeister', 'Affiliation': 'Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Schmidl', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Schmetterer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Garhöfer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria. gerhard.garhoefer@meduniwien.ac.at.'}]",Advances in therapy,['10.1007/s12325-019-01137-8']
180,31471309,Angiogenic Factor and Cytokine Analysis among Patients Treated with Adjuvant VEGFR TKIs in Resected Renal Cell Carcinoma.,"PURPOSE


The use of VEGFR TKIs for the adjuvant treatment of renal cell carcinoma (RCC) remains controversial. We investigated the effects of adjuvant VEGFR TKIs on circulating cytokines in the ECOG-ACRIN 2805 (ASSURE) trial.
EXPERIMENTAL DESIGN


Patients with resected high-risk RCC were randomized to sunitinib, sorafenib, or placebo. Plasma from 413 patients was analyzed from post-nephrectomy baseline, 4 weeks, and 6 weeks after treatment initiation. Mixed effects and Cox proportional hazards models were used to test for changes in circulating cytokines and associations between disease-free survival (DFS) and cytokine levels.
RESULTS


VEGF and PlGF increased after 4 weeks on sunitinib or sorafenib ( P  < 0.0001 for both) and returned to baseline at 6 weeks on sunitinib (corresponding to the break in the sunitinib schedule) but not sorafenib (which was administered continuously). sFLT-1 decreased after 4 weeks on sunitinib and 6 weeks on sorafenib ( P  < 0.0001). sVEGFR-2 decreased after both 4 and 6 weeks of treatment on sunitinib or sorafenib ( P  < 0.0001). Patients receiving placebo had no significant changes in cytokine levels. CXCL10 was elevated at 4 and 6 weeks on sunitinib and sorafenib but not on placebo. Higher baseline CXCL10 was associated with worse DFS (HR 1.41 per log increase in CXCL10, Bonferroni-adjusted  P  = 0.003). This remained significant after adjustment for T-stage, Fuhrman grade, and ECOG performance status.
CONCLUSIONS


Among patients treated with adjuvant VEGFR TKIs for RCC, drug-host interactions mediate changes in circulating cytokines. Elevated baseline CXCL10 was associated with worse DFS. Studies to understand functional consequences of these changes are under way.",2019,Results:  VEGF and PlGF increased after 4 weeks on sunitinib or sorafenib ( P  < 0.0001 for both) and returned to baseline at 6 weeks on sunitinib (corresponding to the break in the sunitinib schedule) but not sorafenib (which was administered continuously).,"['renal cell carcinoma', 'Patients Treated with Adjuvant VEGFR TKIs in Resected Renal Cell Carcinoma', 'Patients with resected high-risk RCC']","['sunitinib, sorafenib, or placebo', 'placebo', 'sunitinib or sorafenib', 'sunitinib and sorafenib', 'adjuvant VEGFR TKIs', 'sorafenib', 'VEGFR TKIs']","['cytokine levels', 'CXCL10', 'circulating cytokines and associations between disease-free survival (DFS) and cytokine levels', 'sFLT-1', 'VEGF and PlGF', 'Angiogenic Factor and Cytokine Analysis', 'sVEGFR-2']","[{'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C1313526', 'cui_str': 'S2FLT'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0002976', 'cui_str': 'Angiogenesis Factor'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",413.0,0.137724,Results:  VEGF and PlGF increased after 4 weeks on sunitinib or sorafenib ( P  < 0.0001 for both) and returned to baseline at 6 weeks on sunitinib (corresponding to the break in the sunitinib schedule) but not sorafenib (which was administered continuously).,"[{'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Maneka', 'Initials': 'M', 'LastName': 'Puligandla', 'Affiliation': 'Dana-Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, Massachusetts.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Manola', 'Affiliation': 'Dana-Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston, Massachusetts.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Bullock', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tamasauskas', 'Affiliation': ''}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'MedStar Georgetown University Hospital, Washington, District of Columbia.'}, {'ForeName': 'Naomi B', 'Initials': 'NB', 'LastName': 'Haas', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Flaherty', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Uzzo', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Janice P', 'Initials': 'JP', 'LastName': 'Dutcher', 'Affiliation': 'The Cancer Research Foundation, Bronx, New York.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Rupal S', 'Initials': 'RS', 'LastName': 'Bhatt', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts. rbhatt@bidmc.harvard.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0818']
181,32294394,"Effects of cultured dairy and nondairy products added to breakfast cereals on blood glucose control, satiation, satiety, and short-term food intake in young women.","Breakfast cereals are often consumed with dairy products or nondairy alternatives; however, the effect of the combination on blood glucose and food intake control is not well investigated. In a randomized, crossover study, 24 healthy women (age: 22.7 ± 2.5 years; body mass index: 22.1 ± 1.5 kg/m 2 ) consumed, to satiation, 1 of 3 treatments: Greek yogurt with granola (150 kcal, 9.2 g protein, 2.6 g fat, 2.0 g dietary fibre, and 21.5 g available carbohydrate/100 g); cultured coconut product with granola (146 kcal, 3.2 g protein, 3.2 g fat, 5.6 g dietary fibre, and 21.9 g available carbohydrate/100 g); or water control. The data were analyzed with repeated-measures ANOVA. The 2 h blood glucose iAUC was 52% lower after the dairy compared with nondairy treatment ( P  < 0.0001). While there were no differences in food intake between the caloric treatments consumed to satiation, protein intake was 3 times higher and fibre intake was 4 times lower after the dairy compared with nondairy treatment. Both caloric treatments resulted in similar suppression of ad libitum food intake at 2 h ( P  < 0.003) and subjective appetite over 2 h ( P  < 0.0001) compared with water. The cumulative food intake over 2 h was lower after water ( P  < 0.05). The 1.8-fold increase in postprandial insulin after dairy compared with nondairy treatment may explain the reduction in blood glucose without an increase in subsequent energy intake.  Novelty  Blood glucose in young females is lower after a breakfast with granola in a high-protein cultured dairy than when in a high-fibre nondairy cultured product. Subjective appetite over 2 h and food intake 2 h later was similarly lower after both breakfasts but cumulative intake was higher compared with breakfast skipping.",2020,• Subjective appetite over 2h and food intake 2h later was similarly lower after both breakfasts but cumulative intake was higher compared to breakfast skipping.,"['young females', 'young women', '24 healthy women (age: 22.7±2.5y; BMI:22.1±1.5kg/m2) consumed, to satiation, one of three treatments: Greek yogurt with granola (150kcal, 9.2g protein']","['cultured coconut product with granola (146kcal, 3.2g protein', 'water control', 'carbohydrate/100', 'cultured dairy and non-dairy products added to breakfast cereals']","['Blood glucose', 'blood glucose control, satiation, satiety, and short-term food intake', 'blood glucose and food intake control', '• Subjective appetite', 'blood glucose', 'Novelty bullets •', 'cumulative intake', 'subjective appetite', 'similar suppression of ad libitum food intake', 'cumulative food intake', 'blood glucose iAUC', 'postprandial insulin', 'fibre intake', 'food intake']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0452820', 'cui_str': 'Greek yogurt'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0086376', 'cui_str': 'G protein'}]","[{'cui': 'C0009210', 'cui_str': 'Cocos nucifera'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0336699', 'cui_str': 'Bullet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]",24.0,0.018672,• Subjective appetite over 2h and food intake 2h later was similarly lower after both breakfasts but cumulative intake was higher compared to breakfast skipping.,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Mather', 'Affiliation': 'Department of Applied Human Nutrition, Mount Saint Vincent University, Halifax, NS B3M 2J6, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Boachie', 'Affiliation': 'Department of Applied Human Nutrition, Mount Saint Vincent University, Halifax, NS B3M 2J6, Canada.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Anini', 'Affiliation': 'Departments of Obstetrics and Gynecology and Physiology and Biophysics, Dalhousie University, Halifax, NS B3H 4R2, Canada.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Panahi', 'Affiliation': 'Department of Kinesiology, Laval University, Quebec City, QC G1V 0A6, Canada.'}, {'ForeName': 'G Harvey', 'Initials': 'GH', 'LastName': 'Anderson', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, ON M5S 3E2, Canada.'}, {'ForeName': 'Bohdan L', 'Initials': 'BL', 'LastName': 'Luhovyy', 'Affiliation': 'Department of Applied Human Nutrition, Mount Saint Vincent University, Halifax, NS B3M 2J6, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0772']
182,32294881,"Health Outcomes of an Integrated Behaviour-Centred Water, Sanitation, Hygiene and Food Safety Intervention-A Randomised before and after Trial.","Diarrhoeal disease in children under five in low income settings has been associated with multiple environmental exposure pathways, including complementary foods. Conducted from February to December 2018 in rural Malawi, this before and after trial with a control used diarrhoeal disease as a primary outcome, to measure the impact of a food hygiene intervention (food hygiene + handwashing) relative to a food hygiene and water, sanitation and hygiene (WASH) intervention (food hygiene + handwashing + faeces management + water management). The 31-week intervention was delivered by community-based coordinators through community events ( n  = 2), cluster group meetings ( n  = 17) and household visits ( n  = 14). Diarrhoeal disease was self-reported and measured through an end line survey, and daily diaries completed by caregivers. Difference-in-differences results show a 13-percentage point reduction in self-reported diarrhoea compared to the control group. There were also significant increases in the presence of proxy measures in each of the treatment groups (e.g., the presence of soap). We conclude that food hygiene interventions (including hand washing with soap) can significantly reduce diarrhoeal disease prevalence in children under five years in a low-income setting. Therefore, the promotion of food hygiene practices using a behaviour-centred approach should be embedded in nutrition and WASH policies and programming.",2020,Difference-in-differences results show a 13-percentage point reduction in self-reported diarrhoea compared to the control group.,"['children under five in low income settings', 'children under five years in a low-income setting']","['food hygiene interventions (including hand washing with soap', 'food hygiene intervention (food hygiene + handwashing) relative to a food hygiene and water, sanitation and hygiene (WASH) intervention (food hygiene + handwashing + faeces management + water management', 'Integrated Behaviour-Centred Water, Sanitation, Hygiene and Food Safety']","['self-reported diarrhoea', 'Diarrhoeal disease', 'presence of proxy measures', 'diarrhoeal disease prevalence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1290807', 'cui_str': 'Diarrheal disorder'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.0252993,Difference-in-differences results show a 13-percentage point reduction in self-reported diarrhoea compared to the control group.,"[{'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Morse', 'Affiliation': 'Centre for Water, Environment, Sustainability and Public Health, Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow G1 1XJ, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tilley', 'Affiliation': 'Department of Environmental Health, University of Malawi (Polytechnic), Blantyre, Malawi.'}, {'ForeName': 'Kondwani', 'Initials': 'K', 'LastName': 'Chidziwisano', 'Affiliation': 'Centre for Water, Environment, Sustainability and Public Health, Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow G1 1XJ, UK.'}, {'ForeName': 'Rossanie', 'Initials': 'R', 'LastName': 'Malolo', 'Affiliation': 'Centre for Water, Sanitation, Health and Appropriate Technology Development (WASHTED), University of Malawi (Polytechnic), Blantyre, Malawi.'}, {'ForeName': 'Janelisa', 'Initials': 'J', 'LastName': 'Musaya', 'Affiliation': 'Department of Biochemical Sciences, College of Medicine, University of Malawi, Blantyre, Malawi.'}]",International journal of environmental research and public health,['10.3390/ijerph17082648']
183,32295131,"Effects of a Psychological Management Program on Subjective Happiness, Anger Control Ability, and Gratitude among Late Adolescent Males in Korea.","This study aimed to develop an emotion management program for late adolescent males, and investigate the effect of the program. This study is an experimental study using a pretest-posttest control group design. It was conducted from 14 May to 21 December, 2018 at a male high school in Korea. It analyzed 52 participants (26 in the experimental group and 26 in the control group.) Regarding subjective happiness, there was a significant difference between groups (t = 3.409,  p  = 0.001). In anger control ability and gratitude, there was no significant difference between groups (t = 0.332,  p  = 0.740/ z = 0.528,  p  = 0.599). This program for emotion management, which is based on the broaden-and-build theory, can improve subjective happiness, anger control ability, and gratitude, by reinforcing appreciation skills and anger awareness and self-expression in male high school students.",2020,"In anger control ability and gratitude, there was no significant difference between groups (t = 0.332,  p  = 0.740/","['14 May to 21 December, 2018 at a male high school in Korea', 'late adolescent males', '52 participants (26 in the experimental group and 26 in the control group', 'male high school students', 'Late Adolescent Males in Korea']","['emotion management program', 'Psychological Management Program']","['Subjective Happiness, Anger Control Ability, and Gratitude', 'subjective happiness']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0120727,"In anger control ability and gratitude, there was no significant difference between groups (t = 0.332,  p  = 0.740/","[{'ForeName': 'Ju Eun', 'Initials': 'JE', 'LastName': 'Hong', 'Affiliation': 'Department of Nursing, Dongyang University, Yeongju 36040, Korea.'}, {'ForeName': 'Miok', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, College of Nursing, Dankook University, Cheonan 31116, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17082683']
184,31712614,Study protocol of a double-blind randomised placebo-controlled trial on the effect of a multispecies probiotic on the incidence of antibiotic-associated diarrhoea in persons with spinal cord injury.,"STUDY DESIGN


Multi-centre, double-blind randomised placebo-controlled study.
OBJECTIVE


To investigate whether the use of a multispecies probiotic can prevent antibiotic-associated diarrhoea in people with spinal cord injury (SCI).
SETTING


Three Dutch SCI rehabilitation centres.
METHODS


Fifty-six people aged 18-75 years with SCI during inpatient rehabilitation, who require antibiotics, will be given probiotics or placebo randomly assigned (T0). After cessation of the antibiotics (T1), the participants will use probiotics/placebo for 3 more weeks (T2). Defaecation, assessed by the Bristol Stool Scale, and bowel management will be monitored daily until 2 weeks after cessation of probiotics/placebo intake (T3). Also, the degree of nausea and information on quality of life will be collected at T0, T1, T2 and T3.
MAIN OUTCOME MEASURES


The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
SECONDARY OUTCOME MEASURES


The time to reach effective bowel management, degree of nausea and quality of life.
REGISTRATION


The Dutch Trial Register- NTR 5831.",2020,"The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
","['persons with spinal cord injury', 'Fifty-six people aged 18-75 years with SCI during inpatient rehabilitation, who require antibiotics, will be given probiotics or placebo randomly assigned (T0', 'Three Dutch SCI rehabilitation centres', 'people with\xa0spinal cord injury (SCI']","['placebo', 'multispecies probiotic', 'probiotics/placebo']","['degree of nausea and information on quality of life', 'incidence of antibiotic-associated diarrhoea', 'Bristol Stool Scale, and bowel management', 'time to reach effective bowel management, degree of nausea and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0578159', 'cui_str': 'Antibiotic-associated diarrhea (disorder)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0222045'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",56.0,0.712196,"The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
","[{'ForeName': 'W X M', 'Initials': 'WXM', 'LastName': 'Faber', 'Affiliation': 'Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands. w.faber@heliomare.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nachtegaal', 'Affiliation': 'Department of Research & Development, Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Stolwijk-Swuste', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Achterberg-Warmer', 'Affiliation': 'Amsterdam Rehabilitation Research Center, Reade, the Netherlands.'}, {'ForeName': 'C J M', 'Initials': 'CJM', 'LastName': 'Koning', 'Affiliation': 'Winclove Probiotics B.V, Amsterdam, The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Besseling-van der Vaart', 'Affiliation': 'Winclove Probiotics B.V, Amsterdam, The Netherlands.'}, {'ForeName': 'C A M', 'Initials': 'CAM', 'LastName': 'van Bennekom', 'Affiliation': 'Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.'}]",Spinal cord,['10.1038/s41393-019-0369-y']
185,30259703,"Building strength, endurance, and mobility using an astaxanthin formulation with functional training in elderly.","BACKGROUND


Building both strength and endurance has been a challenge in exercise training in the elderly, but dietary supplements hold promise as agents for improving muscle adaptation. Here, we test a formulation of natural products (AX: astaxanthin, 12 mg and tocotrienol, 10 mg and zinc, 6 mg) with both anti-inflammatory and antioxidant properties in combination with exercise. We conducted a randomized, double-blind, placebo-controlled study of elderly subjects (65-82 years) on a daily oral dose with interval walking exercise on an incline treadmill.
METHODS


Forty-two subjects were fed AX or placebo for 4 months and trained 3 months (3×/week for 40-60 min) with increasing intervals of incline walking. Strength was measured as maximal voluntary force (MVC) in ankle dorsiflexion exercise, and tibialis anterior muscle size (cross-sectional area, CSA) was determined from magnetic resonance imaging.
RESULTS


Greater endurance (exercise time in incline walking, >50%) and distance in 6 min walk (>8%) accompanied training in both treatments. Increases in MVC by 14.4% (±6.2%, mean ± SEM, P < 0.02, paired t-test), CSA by 2.7% (±1.0%, P < 0.01), and specific force by 11.6% (MVC/CSA, ±6.0%, P = 0.05) were found with AX treatment, but no change was evident in these properties with placebo treatment (MVC, 2.9% ± 5.6%; CSA, 0.6% ± 1.2%; MVC/CSA, 2.4 ± 5.7%; P > 0.6 for all).
CONCLUSIONS


The AX formulation improved muscle strength and CSA in healthy elderly in addition to the elevation in endurance and walking distance found with exercise training alone. Thus, the AX formulation in combination with a functional training programme uniquely improved muscle strength, endurance, and mobility in the elderly.",2018,"Increases in MVC by 14.4% (±6.2%, mean ± SEM, P < 0.02, paired t-test), CSA by 2.7% (±1.0%, P ","['Forty-two subjects were fed', 'elderly', 'healthy elderly', 'elderly subjects (65-82\xa0years']","['daily oral dose with interval walking exercise on an incline treadmill', 'astaxanthin formulation with functional training', 'placebo', 'AX or placebo', 'natural products (AX: astaxanthin, 12\xa0mg and tocotrienol, 10\xa0mg and zinc, 6\xa0mg) with both anti-inflammatory and antioxidant properties in combination with exercise']","['Greater endurance (exercise time in incline walking, >50%) and distance in 6\xa0min walk', 'muscle strength, endurance, and mobility in the elderly', 'muscle strength and CSA', 'MVC', 'Building strength, endurance, and mobility', 'specific force', 'maximal voluntary force (MVC) in ankle dorsiflexion exercise, and tibialis anterior muscle size (cross-sectional area, CSA']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0052565', 'cui_str': 'astaxanthin'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1566558', 'cui_str': 'Natural Products'}, {'cui': 'C0949647', 'cui_str': 'Tocotrienols'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0439587', 'cui_str': 'Exercise time (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242690', 'cui_str': 'Anterior Tibial Muscle'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",42.0,0.0491361,"Increases in MVC by 14.4% (±6.2%, mean ± SEM, P < 0.02, paired t-test), CSA by 2.7% (±1.0%, P ","[{'ForeName': 'Sophia Z', 'Initials': 'SZ', 'LastName': 'Liu', 'Affiliation': 'Translational Center for Metabolic Imaging Department of Radiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Amir S', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Translational Center for Metabolic Imaging Department of Radiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Campbell', 'Affiliation': 'Translational Center for Metabolic Imaging Department of Radiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kilroy', 'Affiliation': 'Translational Center for Metabolic Imaging Department of Radiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Eric G', 'Initials': 'EG', 'LastName': 'Shankland', 'Affiliation': 'Translational Center for Metabolic Imaging Department of Radiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Baback', 'Initials': 'B', 'LastName': 'Roshanravan', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Marcinek', 'Affiliation': 'Translational Center for Metabolic Imaging Department of Radiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Conley', 'Affiliation': 'Translational Center for Metabolic Imaging Department of Radiology, University of Washington, Seattle, WA.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12318']
186,32244970,Analysis of the Components of a Cognitive-Behavioral Intervention for the prevention of Depression Administered via Conference Call to Nonprofessional Caregivers: A Randomized Controlled Trial.,"Effective and accessible interventions for indicated prevention of depression are necessary and lacking, especially for informal caregivers. Although telephone-based interventions could increase the accessibility for caregivers, randomized controlled trials are scarce, with no examination of prevention to date. Moreover, the efficacy of specific therapeutic components in preventive cognitive-behavioral programs is unknown. The main objective of this study was to evaluate the efficacy of a telephone-administered psychological preventive intervention in informal caregivers with high depressive symptoms. A total of 219 caregivers were randomized to a cognitive-behavioral conference call intervention (CBCC,  n  = 69), a behavioral-activation conference call intervention (BACC,  n  = 70), or a usual care control group (CG,  n  = 80). Both interventions consisted of five 90-minute group sessions. At the post-intervention, incidence of depression was lower in CBCC and BACC compared to CG (1.5% and 1.4% vs. 8.8%). Relative risk was 0.17 for the CBCC and 0.16 for the BACC, and the number-needed-to-treat was 14 in both groups. Depressive symptoms were significantly lower in BACC and BACC groups compared to CG ( d  = 1.16 and 1.29), with no significant differences between CBCC and BACC groups. The conference call intervention was effective in preventing depression and the behavioral-activation component (BACC) was comparable to the CBCC intervention.",2020,"Depressive symptoms were significantly lower in BACC and BACC groups compared to CG ( d  = 1.16 and 1.29), with no significant differences between CBCC and BACC groups.","['219 caregivers', 'informal caregivers with high depressive symptoms', 'Nonprofessional Caregivers']","['telephone-administered psychological preventive intervention', 'Cognitive-Behavioral Intervention', 'cognitive-behavioral conference call intervention (CBCC,  n  = 69), a behavioral-activation conference call intervention (BACC,  n  = 70), or a usual care control', 'telephone-based interventions']","['Depressive symptoms', 'incidence of depression', 'Relative risk', 'number-needed-to-treat', 'depression and the behavioral-activation component (BACC']","[{'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0615341', 'cui_str': 'cyclobutanecarbonylcarnitine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",219.0,0.043047,"Depressive symptoms were significantly lower in BACC and BACC groups compared to CG ( d  = 1.16 and 1.29), with no significant differences between CBCC and BACC groups.","[{'ForeName': 'Fernando L', 'Initials': 'FL', 'LastName': 'Vázquez', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15705 Santiago de Compostela, Spain.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'López', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15705 Santiago de Compostela, Spain.'}, {'ForeName': 'Ángela J', 'Initials': 'ÁJ', 'LastName': 'Torres', 'Affiliation': 'Department of Psychiatry, Radiology and Public Health, University of Santiago de Compostela, 15705 Santiago de Compostela, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Otero', 'Affiliation': 'Department of Psychology, University of A Coruña, 15001 A Coruña, Spain.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Blanco', 'Affiliation': 'Department of Evolutionary and Educational Psychology, University of Santiago de Compostela, 15705 Santiago de Compostela, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Díaz', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15705 Santiago de Compostela, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Páramo', 'Affiliation': 'Department of Psychiatry, Radiology and Public Health, University of Santiago de Compostela, 15705 Santiago de Compostela, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17062067']
187,32289294,Crossover to Photodynamic Therapy or Micropulse Laser After Failure of Primary Treatment of Chronic Central Serous Chorioretinopathy: The REPLACE Trial.,"PURPOSE


To assess whether chronic central serous chorioretinopathy (cCSC) patients without a complete resolution of subretinal fluid (SRF) after either half-dose photodynamic therapy (PDT) or high-density subthreshold micropulse laser (HSML) treatment may benefit from crossover treatment.
DESIGN


Multicenter prospective interventional case series.
METHODS


cCSC patients with persistent SRF at the final visit of the PLACE trial were included. Patients received crossover treatment with either half-dose PDT or HSML.
RESULTS


Thirty-two patients received PDT and 10 patients received HSML. At the first evaluation visit (6-8 weeks after treatment), 81% of patients in the PDT group had complete resolution of SRF, while none of the HSML-treated patients had complete resolution of SRF. At final visit (1 year after baseline), 78% (P = .030) and 67% (P = .109) of the patients, respectively, had a complete resolution of SRF. The mean retinal sensitivity in the PDT group increased from 21.7 dB (standard error [SE]: 0.9) to 23.4 dB (SE: 0.8) at evaluation visit 1 (P = .003), to 24.7dB (SE: 0.8) at final visit (P < .001), while there were no significant changes in the HSML group (23.7 dB [SE: 1.6] at baseline, 23.8 dB [SE: 1.4] at evaluation 1, and 23.3 dB [SE: 1.4] at final visit). The mean visual acuity and mean visual quality-of-life questionnaire score did not change significantly in both groups.
CONCLUSIONS


Crossover to half-dose PDT after previous unsuccessful HSML treatment for cCSC may lead to improved anatomic and functional endpoints, while crossover to HSML after half-dose PDT does not seem to significantly affect these endpoints.",2020,"The mean visual acuity and mean visual quality of life questionnaire score did not change significantly in both groups.
","['chronic central serous chorioretinopathy (cCSC) patients without a complete resolution of subretinal fluid (SRF) after either half-dose', 'chronic central serous chorioretinopathy', 'cCSC patients with persistent SRF at the final visit of the PLACE trial were included']","['photodynamic therapy (PDT) or high-density subthreshold micropulse laser (HSML', 'photodynamic therapy or micropulse laser', 'HSML']","['mean visual acuity and mean visual quality of life questionnaire score', 'mean retinal sensitivity', 'complete resolution of SRF']","[{'cui': 'C0730314', 'cui_str': 'Chronic central serous chorioretinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}]",,0.0548009,"The mean visual acuity and mean visual quality of life questionnaire score did not change significantly in both groups.
","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'van Rijssen', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Elon H C', 'Initials': 'EHC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Scholz', 'Affiliation': 'Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Myrte B', 'Initials': 'MB', 'LastName': 'Breukink', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Dijkman', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Petrus J H', 'Initials': 'PJH', 'LastName': 'Peters', 'Affiliation': 'Department of Ophthalmology, Bergman Clinics B.V., Velp, The Netherlands.'}, {'ForeName': 'Roula', 'Initials': 'R', 'LastName': 'Tsonaka', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'MacLaren', 'Affiliation': 'Oxford Eye Hospital, John Radcliffe Hospital, West Wing, Oxford, United Kingdom.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Downes', 'Affiliation': 'Oxford Eye Hospital, John Radcliffe Hospital, West Wing, Oxford, United Kingdom.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Fauser', 'Affiliation': 'Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany; F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Camiel J F', 'Initials': 'CJF', 'LastName': 'Boon', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands; Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: c.j.f.boon@lumc.nl.'}, {'ForeName': 'Carel B', 'Initials': 'CB', 'LastName': 'Hoyng', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.04.007']
188,32290136,Strength plus Endurance Training and Individualized Diet Reduce Fat Mass in Overweight Subjects: A Randomized Clinical Trial.,"Studies with overweight people are a priority in order to observe the effect of the timing of intervention on pre-obesity people. The aim was to compare different physical activity programs plus an individualized hypocaloric diet on body composition in overweight subjects. A randomized controlled clinical trial was carried out in overweight adults with no history of relevant illness. Primary outcome was total fat mass (TFM). Participants were allocated into four activity programs with equal intensity and volume of exercise for 22 weeks: strength training (S), endurance training (E), strength + endurance training (SE), and 'adhering to physical activity recommendations' (C). Participants followed a diet with 25% less energy (50%-55% carbohydrates, 30%-35% fat) measured by accelerometer. Variables were assessed at baseline and at the end of the intervention. Body composition was measured by dual-energy X-ray absorptiometry. One hundred nineteen from 205 subjects were randomized in the four exercise groups (S = 30/E = 30/SE = 30/C = 29) and 84 participants (36 men/48 women) ended the intervention (S = 19/E = 25/SE = 22/C = 18). At the end of the experiment, all groups except C increased their total physical activity (S = 1159 ± 1740; E = 1625 ± 1790; SE = 1699 ± 2516; C = 724 ± 1979 MET-min/week). Using an ANOVA-test, improvements were observed in body weight (S = -4.6 ± 4.5; E = -6.6 ± 4.6; SE = -8.5 ± 2.8; C = -6.1 ± 5.6 kg,  p  = 0.059) and TFM (S = -4.24 ± 2.02; E = -4.74 ± 2.96; SE = -6.74 ± 3.27; C = -3.94 ± 4.18%;  p  < 0.05). The main conclusion was that there were no adverse events. Strength and endurance training with a balanced, individualized hypocaloric diet was the most effective at reducing weight loss and fat mass in overweight subjects. Trial registration: NCT01116856.",2020,"Strength and endurance training with a balanced, individualized hypocaloric diet was the most effective at reducing weight loss and fat mass in overweight subjects.","['One hundred nineteen from 205 subjects', 'overweight adults with no history of relevant illness', 'Overweight Subjects', 'overweight subjects']","['Strength plus Endurance Training and Individualized Diet', 'physical activity programs plus an individualized hypocaloric diet', ""activity programs with equal intensity and volume of exercise for 22 weeks: strength training (S), endurance training (E), strength + endurance training (SE), and 'adhering to physical activity recommendations' (C"", 'Strength and endurance training with a balanced, individualized hypocaloric diet']","['total fat mass (TFM', 'body composition', 'total physical activity', 'weight loss and fat mass', 'Body composition', 'body weight']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",36.0,0.0451208,"Strength and endurance training with a balanced, individualized hypocaloric diet was the most effective at reducing weight loss and fat mass in overweight subjects.","[{'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Benito', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Bricia', 'Initials': 'B', 'LastName': 'López-Plaza', 'Affiliation': 'Department of Nutrition, Hospital La Paz Health Research Institute (IdiPAZ), La Paz University Hospital, 28046 Madrid, Spain.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bermejo', 'Affiliation': 'Department of Nutrition, Hospital La Paz Health Research Institute (IdiPAZ), La Paz University Hospital, 28046 Madrid, Spain.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Peinado', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Cupeiro', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Butragueño', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Rojo-Tirado', 'Affiliation': 'LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science-INEF, Universidad Politécnica de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'González-Lamuño', 'Affiliation': 'Laboratory of Pediatrics, Department of Medical and Surgery Sciences, Faculty of Medicine, University of Cantabria, Marqués de Valdecilla Biomedical Research Institute (IDIVAL), 39011 Santander, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Gómez-Candela', 'Affiliation': 'Department of Nutrition, Hospital La Paz Health Research Institute (IdiPAZ), La Paz University Hospital, 28046 Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of The Pronaf Study Group', 'Affiliation': ''}]",International journal of environmental research and public health,['10.3390/ijerph17072596']
189,32271146,Combined aerobic resistance exercise improves dialysis adequacy and quality of life in patients on maintenance hemodialysis
.,"OBJECTIVE


This study aims to compare the effect of pure aerobic exercise and combined aerobic resistance exercise on dialysis adequacy and quality of life in patients on maintenance hemodialysis.
MATERIALS AND METHODS


A total of 45 patients on maintenance hemodialysis were divided into three groups: pure aerobic exercise group, combined aerobic resistance exercise group, and control group. Patients in the control group were only given the usual treatment, which included dietary guidance, drug therapy, and hemodialysis. The other training groups underwent 12-week exercise intervention therapy on the basis of the usual treatment. Blood samples were collected before and after the hemodialysis, at the beginning and end of the intervention for these three groups. Then, the blood urea nitrogen (BUN) concentration was determined, the urea clearance index (Kt/v) and urea degradation rate (URR) were calculated, the dialysis adequacy was evaluated, and the short form-36 (SF-36) scale was used to evaluate the life quality.
RESULTS


Before intervention, there was no significant difference in general health condition (GH), Kt/v, URR, SF-36 total score, and the score of each dimension in the three groups. After the intervention therapy, the Kt/v, URR, GH, vitality (VT), and SF-36 total score markedly improved in the pure aerobic exercise group, while the Kt/v, URR, GH, VT, physical functioning (PF), and SF-36 total score significantly increased in the combined aerobic resistance exercise group. Furthermore, compared with the pure aerobic exercise group, the improvement effect of body function (PF score) was better in the combined aerobic resistance exercise group.
CONCLUSION


Both pure aerobic exercise and combined aerobic resistance exercise can significantly improve the dialysis adequacy and quality of life of maintenance hemodialysis patients. Compared with the pure aerobic exercise group, the effect of combined aerobic resistance exercise on PF was better.
.",2020,Both pure aerobic exercise and combined aerobic resistance exercise can significantly improve the dialysis adequacy and quality of life of maintenance hemodialysis patients.,"['patients on maintenance hemodialysis', '45 patients on maintenance hemodialysis', 'maintenance hemodialysis patients', 'patients on maintenance hemodialysis\u2029']","['combined aerobic resistance exercise', 'pure aerobic exercise and combined aerobic resistance exercise', 'pure aerobic exercise group, combined aerobic resistance exercise group, and control group', 'Combined aerobic resistance exercise', 'pure aerobic exercise', 'exercise intervention therapy']","['urea clearance index (Kt/v) and urea degradation rate (URR', 'short form-36 (SF-36) scale', 'body function (PF score', 'Blood samples', 'dialysis adequacy and quality of life', 'general health condition (GH), Kt/v, URR, SF-36 total score, and the score of each dimension', 'Kt/v, URR, GH, vitality (VT), and SF-36 total score', 'URR, GH, VT, physical functioning (PF), and SF-36 total score', 'blood urea nitrogen (BUN) concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1318428', 'cui_str': 'Urea clearance measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429662', 'cui_str': 'kt/V'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",45.0,0.022542,Both pure aerobic exercise and combined aerobic resistance exercise can significantly improve the dialysis adequacy and quality of life of maintenance hemodialysis patients.,"[{'ForeName': 'Jianrong', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Qige', 'Initials': 'Q', 'LastName': 'Qi', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Dongying', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': ''}]",Clinical nephrology,['10.5414/CN110033']
190,31699292,Comment on: Conbercept for Treatment of Neovascular Age-related Macular Degeneration: Results of the Randomized Phase 3 PHOENIX Study.,,2020,,['Neovascular Age-related Macular Degeneration'],['Conbercept'],[],"[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}]",[],,0.0206817,,"[{'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Grzybowski', 'Affiliation': 'Olsztyn, Poland; Poznan, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kanclerz', 'Affiliation': 'Gdańsk, Poland.'}]",American journal of ophthalmology,['10.1016/j.ajo.2019.07.026']
191,31703120,Effect of Vitamin D and Omega-3 Fatty Acid Supplementation on Kidney Function in Patients With Type 2 Diabetes: A Randomized Clinical Trial.,"Importance


Chronic kidney disease (CKD) is a common complication of type 2 diabetes that can lead to end-stage kidney disease and is associated with high cardiovascular risk. Few treatments are available to prevent CKD in type 2 diabetes.
Objective


To test whether supplementation with vitamin D3 or omega-3 fatty acids prevents development or progression of CKD in type 2 diabetes.
Design, Setting, and Participants


Randomized clinical trial with a 2 × 2 factorial design conducted among 1312 adults with type 2 diabetes recruited between November 2011 and March 2014 from all 50 US states as an ancillary study to the Vitamin D and Omega-3 Trial (VITAL), coordinated by a single center in Massachusetts. Follow-up was completed in December 2017.
Interventions


Participants were randomized to receive vitamin D3 (2000 IU/d) and omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid; 1 g/d) (n = 370), vitamin D3 and placebo (n = 333), placebo and omega-3 fatty acids (n = 289), or 2 placebos (n = 320) for 5 years.
Main Outcomes and Measures


The primary outcome was change in glomerular filtration rate estimated from serum creatinine and cystatin C (eGFR) from baseline to year 5.
Results


Among 1312 participants randomized (mean age, 67.6 years; 46% women; 31% of racial or ethnic minority), 934 (71%) completed the study. Baseline mean eGFR was 85.8 (SD, 22.1) mL/min/1.73 m2. Mean change in eGFR from baseline to year 5 was -12.3 (95% CI, -13.4 to -11.2) mL/min/1.73 m2 with vitamin D3 vs -13.1 (95% CI, -14.2 to -11.9) mL/min/1.73 m2 with placebo (difference, 0.9 [95% CI, -0.7 to 2.5] mL/min/1.73 m2). Mean change in eGFR was -12.2 (95% CI, -13.3 to -11.1) mL/min/1.73 m2 with omega-3 fatty acids vs -13.1 (95% CI, -14.2 to -12.0) mL/min/1.73 m2 with placebo (difference, 0.9 [95% CI, -0.7 to 2.6] mL/min/1.73 m2). There was no significant interaction between the 2 interventions. Kidney stones occurred among 58 participants (n = 32 receiving vitamin D3 and n = 26 receiving placebo) and gastrointestinal bleeding among 45 (n = 28 receiving omega-3 fatty acids and n = 17 receiving placebo).
Conclusions and Relevance


Among adults with type 2 diabetes, supplementation with vitamin D3 or omega-3 fatty acids, compared with placebo, resulted in no significant difference in change in eGFR at 5 years. The findings do not support the use of vitamin D or omega-3 fatty acid supplementation for preserving kidney function in patients with type 2 diabetes.
Trial Registration


ClinicalTrials.gov Identifier: NCT01684722.",2019,"Kidney stones occurred among 58 participants (n = 32 receiving vitamin D3 and n = 26 receiving placebo) and gastrointestinal bleeding among 45 (n = 28 receiving omega-3 fatty acids and n = 17 receiving placebo).
","['1312 participants randomized (mean age, 67.6 years; 46% women; 31% of racial or ethnic minority), 934 (71%) completed the study', 'adults with type 2 diabetes', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes', 'Importance\n\n\nChronic kidney disease (CKD', '1312 adults with type 2 diabetes recruited between November 2011 and March 2014 from all 50 US states as an ancillary study to the Vitamin D and Omega-3 Trial']","['Vitamin D and Omega-3 Fatty Acid Supplementation', 'omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid', 'vitamin D3 and placebo', 'omega-3 fatty acids and n\u2009=\u200917 receiving placebo', 'vitamin D3 or omega-3 fatty acids', ' mL', 'placebo', 'mL', 'vitamin D3', 'placebo and omega-3 fatty acids (n\u2009=\u2009289), or 2 placebos', 'omega-3 fatty acids', 'vitamin D or omega-3 fatty acid supplementation']","['Kidney stones', 'gastrointestinal bleeding', 'Mean change in eGFR', 'Baseline mean eGFR', 'Kidney Function', 'change in eGFR', 'glomerular filtration rate estimated from serum creatinine and cystatin C (eGFR', 'kidney function']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}]",1312.0,0.488501,"Kidney stones occurred among 58 participants (n = 32 receiving vitamin D3 and n = 26 receiving placebo) and gastrointestinal bleeding among 45 (n = 28 receiving omega-3 fatty acids and n = 17 receiving placebo).
","[{'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Leila R', 'Initials': 'LR', 'LastName': 'Zelnick', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ruzinski', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Friedenberg', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Duszlak', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Vadim Y', 'Initials': 'VY', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Hoofnagle', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Thadhani', 'Affiliation': 'Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Sesso', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA,['10.1001/jama.2019.17380']
192,32290072,"The Effect of Active Plus, a Computer-Tailored Physical Activity Intervention, on the Physical Activity of Older Adults with Chronic Illness(es)-A Cluster Randomized Controlled Trial.","eHealth interventions aimed at improving physical activity (PA) can reach large populations with few resources and demands on the population as opposed to centre-based interventions. Active Plus is a proven effective computer-tailored PA intervention for the older adult population focusing on PA in daily life. This manuscript describes the effects of the Active Plus intervention ( N  = 260) on PA of older adults with chronic illnesses (OACI), compared to a waiting list control group ( N  = 325). It was part of a larger randomized controlled trial (RCT) on the effects of the Active Plus intervention on cognitive functioning. OACI (≥65 years) with at least one chronic illness were allocated to one of the conditions. Intervention group participants received PA advice. Baseline and follow-up measurements were assessed after 6 and 12 months. Intervention effects on objectively measured light PA (LPA) and moderate-to-vigorous PA (MVPA) min/week were analysed with multilevel linear mixed-effects models adjusted for the clustered design. Intervention effects on self-reported MVPA min/week on common types of PA were analysed with two-part generalized linear mixed-effects models adjusted for the clustered design. The dropout rate was 19.1% after 6 months and 25.1% after 12 months. Analyses showed no effects on objectively measured PA. Active Plus increased the likelihood to perform self-reported cycling and gardening at six months and participants who cycled increased their MVPA min/week of cycling. Twelve months after baseline the intervention increased the likelihood to perform self-reported walking and participants who cycled at 12 months increased their MVPA min/week of cycling. Subgroup analyses showed that more vulnerable participants (higher degree of impairment, age or body mass index) benefitted more from the intervention on especially the lower intensity PA outcomes. In conclusion, Active Plus only increased PA behaviour to a limited extent in OACI 6 and 12 months after baseline measurements. The Active Plus intervention may yet be not effective enough by itself in OACI. A blended approach, where this eHealth intervention and face-to-face contact are combined, is advised to improve the effects of Active Plus on PA in this target group.",2020,Twelve months after baseline the intervention increased the likelihood to perform self-reported walking and participants who cycled at 12 months increased their MVPA min/week of cycling.,"['group ( N  = 325', '≥65 years) with at least one chronic illness', 'Older Adults with Chronic Illness(es)-A Cluster', 'older adults with chronic illnesses (OACI']","['PA advice', 'waiting list control', 'Active Plus, a Computer-Tailored Physical Activity Intervention', 'OACI', 'Active Plus intervention']","['objectively measured light PA (LPA) and moderate-to-vigorous PA (MVPA', 'cognitive functioning', 'PA behaviour', 'dropout rate']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0837253,Twelve months after baseline the intervention increased the likelihood to perform self-reported walking and participants who cycled at 12 months increased their MVPA min/week of cycling.,"[{'ForeName': 'Esmee', 'Initials': 'E', 'LastName': 'Volders', 'Affiliation': 'Faculty of Psychology, Open University of The Netherlands, 6419 AT Heerlen, The Netherlands.'}, {'ForeName': 'Catherine A W', 'Initials': 'CAW', 'LastName': 'Bolman', 'Affiliation': 'Faculty of Psychology, Open University of The Netherlands, 6419 AT Heerlen, The Netherlands.'}, {'ForeName': 'Renate H M', 'Initials': 'RHM', 'LastName': 'de Groot', 'Affiliation': 'Faculty of Educational Sciences, Open University of The Netherlands, 6419 AT Heerlen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verboon', 'Affiliation': 'Faculty of Psychology, Open University of The Netherlands, 6419 AT Heerlen, The Netherlands.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Lechner', 'Affiliation': 'Faculty of Psychology, Open University of The Netherlands, 6419 AT Heerlen, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17072590']
193,31679945,"Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study.","BACKGROUND


Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response.
METHODS


KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries. Participants were stratified by PD-L1 expression, p16 status, and performance status and randomly allocated (1:1:1) to pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy). Investigators and participants were aware of treatment assignment. Investigators, participants, and representatives of the sponsor were masked to the PD-L1 combined positive score (CPS) results; PD-L1 positivity was not required for study entry. The primary endpoints were overall survival (time from randomisation to death from any cause) and progression-free survival (time from randomisation to radiographically confirmed disease progression or death from any cause, whichever came first) in the intention-to-treat population (all participants randomly allocated to a treatment group). There were 14 primary hypotheses: superiority of pembrolizumab alone and of pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival and progression-free survival in the PD-L1 CPS of 20 or more, CPS of 1 or more, and total populations and non-inferiority (non-inferiority margin: 1·2) of pembrolizumab alone and pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival in the total population. The definitive findings for each hypothesis were obtained when statistical testing was completed for that hypothesis; this occurred at the second interim analysis for 11 hypotheses and at final analysis for three hypotheses. Safety was assessed in the as-treated population (all participants who received at least one dose of allocated treatment). This study is registered at ClinicalTrials.gov, number NCT02358031.
FINDINGS


Between April 20, 2015, and Jan 17, 2017, 882 participants were allocated to receive pembrolizumab alone (n=301), pembrolizumab with chemotherapy (n=281), or cetuximab with chemotherapy (n=300); of these, 754 (85%) had CPS of 1 or more and 381 (43%) had CPS of 20 or more. At the second interim analysis, pembrolizumab alone improved overall survival versus cetuximab with chemotherapy in the CPS of 20 or more population (median 14·9 months vs 10·7 months, hazard ratio [HR] 0·61 [95% CI 0·45-0·83], p=0·0007) and CPS of 1 or more population (12·3 vs 10·3, 0·78 [0·64-0·96], p=0·0086) and was non-inferior in the total population (11·6 vs 10·7, 0·85 [0·71-1·03]). Pembrolizumab with chemotherapy improved overall survival versus cetuximab with chemotherapy in the total population (13·0 months vs 10·7 months, HR 0·77 [95% CI 0·63-0·93], p=0·0034) at the second interim analysis and in the CPS of 20 or more population (14·7 vs 11·0, 0·60 [0·45-0·82], p=0·0004) and CPS of 1 or more population (13·6 vs 10·4, 0·65 [0·53-0·80], p<0·0001) at final analysis. Neither pembrolizumab alone nor pembrolizumab with chemotherapy improved progression-free survival at the second interim analysis. At final analysis, grade 3 or worse all-cause adverse events occurred in 164 (55%) of 300 treated participants in the pembrolizumab alone group, 235 (85%) of 276 in the pembrolizumab with chemotherapy group, and 239 (83%) of 287 in the cetuximab with chemotherapy group. Adverse events led to death in 25 (8%) participants in the pembrolizumab alone group, 32 (12%) in the pembrolizumab with chemotherapy group, and 28 (10%) in the cetuximab with chemotherapy group.
INTERPRETATION


Based on the observed efficacy and safety, pembrolizumab plus platinum and 5-fluorouracil is an appropriate first-line treatment for recurrent or metastatic HNSCC and pembrolizumab monotherapy is an appropriate first-line treatment for PD-L1-positive recurrent or metastatic HNSCC.
FUNDING


Merck Sharp & Dohme.",2019,Neither pembrolizumab alone nor pembrolizumab with chemotherapy improved progression-free survival at the second interim analysis.,"['recurrent or metastatic squamous cell carcinoma of the head and neck', 'head and neck squamous cell carcinoma (HNSCC', '0·65', '0·61', 'Between April 20, 2015, and Jan 17, 2017, 882 participants', 'participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries']","['pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy', 'Pembrolizumab with chemotherapy', 'pembrolizumab', 'pembrolizumab alone', 'Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy', 'pembrolizumab plus platinum and 5-fluorouracil', 'pembrolizumab with chemotherapy (n=281), or cetuximab with chemotherapy', 'pembrolizumab alone and pembrolizumab with chemotherapy versus cetuximab with chemotherapy', 'cetuximab with chemotherapy', 'pembrolizumab alone nor pembrolizumab with chemotherapy', 'pembrolizumab with chemotherapy versus cetuximab with chemotherapy']","['adverse events', 'Safety', 'progression-free survival', 'hazard ratio [HR', 'overall survival', 'overall survival (time from randomisation to death from any cause) and progression-free survival', 'overall survival and progression-free survival']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",882.0,0.211751,Neither pembrolizumab alone nor pembrolizumab with chemotherapy improved progression-free survival at the second interim analysis.,"[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, USA. Electronic address: barbara.burtness@yale.edu.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Harrington', 'Affiliation': 'The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust National Institute of Health Research Biomedical Research Centre, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Paracelsus Medical University, Salzburg Cancer Research Institute, Salzburg, Austria; Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Soulières', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'de Castro', 'Affiliation': 'Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Psyrri', 'Affiliation': 'National Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece.'}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Basté', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Neupane', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Bratland', 'Affiliation': 'Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Fuereder', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Brett G M', 'Initials': 'BGM', 'LastName': 'Hughes', 'Affiliation': ""Royal Brisbane and Women's Hospital and University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Mesía', 'Affiliation': 'Catalan Institute of Oncology, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Nuttapong', 'Initials': 'N', 'LastName': 'Ngamphaiboon', 'Affiliation': 'Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rordorf', 'Affiliation': 'University Hospital, Zurich, Switzerland.'}, {'ForeName': 'Wan Zamaniah', 'Initials': 'WZ', 'LastName': 'Wan Ishak', 'Affiliation': 'University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ruey-Long', 'Initials': 'RL', 'LastName': 'Hong', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'González Mendoza', 'Affiliation': 'Unidad de Investigación en Salud, Chihuahua, Mexico.'}, {'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Yayan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Burak', 'Initials': 'B', 'LastName': 'Gumuscu', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Cheng', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Jin', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Austrialia; University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)32591-7']
194,31931275,Plasma oxylipins and unesterified precursor fatty acids are altered by DHA supplementation in pregnancy: Can they help predict risk of preterm birth?,"Oxidized lipids derived from omega-6 (n-6) and omega-3 (n-3) polyunsaturated fatty acids, collectively known as oxylipins, are bioactive signaling molecules that play diverse roles in human health and disease. Supplementation with n-3 docosahexaenoic acid (DHA) during pregnancy has been reported to decrease the risk of preterm birth in singleton pregnancies, which may be due to effects of DHA supplementation on oxylipins or their precursor n-6 and n-3 fatty acids. There is only limited understanding of the levels and trajectory of changes in plasma oxylipins during pregnancy, effects of DHA supplementation on oxylipins and unesterified fatty acids, and whether and how oxylipins and their unesterified precursor fatty acids influence preterm birth. In the present study we used liquid chromatography-tandem mass spectrometry to profile oxylipins and their precursor fatty acids in the unesterified pool using plasma samples collected from a subset of pregnant Australian women who participated in the ORIP (Omega-3 fats to Reduce the Incidence of Prematurity) study. ORIP is a large randomized controlled trial testing whether daily supplementation with n-3 DHA can reduce the incidence of early preterm birth compared to control. Plasma was collected at study entry (≈pregnancy week 14) and again at ≈week 24, in a subgroup of 48 ORIP participants-12 cases with spontaneous preterm (<37 weeks) birth and 36 matched controls with spontaneous term (≥40 weeks) birth. In the combined preterm and term pregnancies, we observed that in the control group without DHA supplementation unesterified AA and AA-derived oxylipins 12-HETE, 15-HETE and TXB2 declined between weeks 14-24 of pregnancy. Compared to control, DHA supplementation increased unesterified DHA, EPA, and AA, DHA-derived 4-HDHA, 10-HDHA and 19,20-EpDPA, and AA-derived 12-HETE at 24 weeks. In exploratory analysis independent of DHA supplementation, participants with concentrations above the median for 5-lipoxygenase derivatives of AA (5-HETE, Odds Ratio (OR) 8.2; p = 0.014) or DHA (4-HDHA, OR 8.0; p = 0.015) at 14 weeks, or unesterified AA (OR 5.1; p = 0.038) at 24 weeks had higher risk of spontaneous preterm birth. The hypothesis that 5-lipoxygenase-derived oxylipins and unesterified AA could serve as mechanism-based biomarkers predicting spontaneous preterm birth should be evaluated in larger, adequately powered studies.",2020,"Compared to control, DHA supplementation increased unesterified DHA, EPA, and AA, DHA-derived 4-HDHA, 10-HDHA and 19,20-EpDPA, and AA-derived 12-HETE at 24 weeks.","['ORIP participants-12 cases with spontaneous preterm (<37 weeks) birth and 36 matched controls with spontaneous term (≥40 weeks) birth', 'singleton pregnancies', 'pregnant Australian women who participated in the']","['n-3 docosahexaenoic acid (DHA', 'liquid chromatography-tandem mass spectrometry to profile oxylipins and their precursor fatty acids', '5-lipoxygenase-derived oxylipins and unesterified AA', 'Oxidized lipids derived from omega-6 (n-6) and omega-3 (n-3) polyunsaturated fatty acids', 'ORIP (Omega-3 fats', 'n-3 DHA']","['risk of spontaneous preterm birth', 'unesterified DHA, EPA, and AA, DHA-derived 4-HDHA, 10-HDHA and 19,20-EpDPA, and AA-derived 12-HETE', 'incidence of early preterm birth']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0008565', 'cui_str': 'Liquid Chromatography'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0003693', 'cui_str': 'LTA4 Synthase'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0044800', 'cui_str': '12-HETE'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",,0.359722,"Compared to control, DHA supplementation increased unesterified DHA, EPA, and AA, DHA-derived 4-HDHA, 10-HDHA and 19,20-EpDPA, and AA-derived 12-HETE at 24 weeks.","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Ramsden', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging, National Institutes of Health, Baltimore, MD, USA; National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA; School of Agriculture, Food and Wine, University of Adelaide, Adelaide, SA, Australia. Electronic address: chris.ramsden@nih.gov.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'School of Medicine, University of Adelaide, Adelaide, SA, Australia; South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Zhi-Xin', 'Initials': 'ZX', 'LastName': 'Yuan', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Horowitz', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Zamora', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Lisa N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'South Australian Health and Medical Research Institute, Adelaide, SA, Australia; School of Public Health, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Best', 'Affiliation': 'School of Medicine, University of Adelaide, Adelaide, SA, Australia; South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Ameer Y', 'Initials': 'AY', 'LastName': 'Taha', 'Affiliation': 'Department of Food Science and Technology, College of Agriculture and Environmental Sciences, University of California, Davis, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'School of Agriculture, Food and Wine, University of Adelaide, Adelaide, SA, Australia; South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2019.102041']
195,31839529,"Intrathecal enzyme replacement for cognitive decline in mucopolysaccharidosis type I, a randomized, open-label, controlled pilot study.","Central nervous system manifestations of mucopolysaccharidosis type I (MPS I) such as cognitive impairment, hydrocephalus, and spinal cord compression are inadequately treated by intravenously-administered enzyme replacement therapy with laronidase (recombinant human alpha-L-iduronidase). While hematopoietic stem cell transplantation treats neurological symptoms, this therapy is not generally offered to attenuated MPS I patients. This study is a randomized, open-label, controlled pilot study of intrathecal laronidase in eight attenuated MPS I patients with cognitive impairment. Subjects ranged between 12 years and 50 years old with a median age of 18 years. All subjects had received intravenous laronidase prior to the study over a range of 4 to 10 years, with a mean of 7.75 years. Weekly intravenous laronidase was continued throughout the duration of the study. The randomization period was one year, during which control subjects attended all study visits and assessments, but did not receive any intrathecal laronidase. After the first year, all eight subjects received treatment for one additional year. There was no significant difference in neuropsychological assessment scores between control or treatment groups, either over the one-year randomized period or at 18 or 24 months. However, there was no significant decline in scores in the control group either. Adverse events included pain (injection site, back, groin), headache, neck spasm, and transient blurry vision. There were seven serious adverse events, one judged as possibly related (headache requiring hospitalization). There was no significant effect of intrathecal laronidase on cognitive impairment in older, attenuated MPS I patients over a two-year treatment period. A five-year open-label extension study is underway.",2020,"There was no significant effect of intrathecal laronidase on cognitive impairment in older, attenuated MPS","['All subjects had received intravenous laronidase prior to the study over a range of 4 to 10\xa0years, with a mean of 7.75\xa0years', 'mucopolysaccharidosis type I', 'Subjects ranged between 12\xa0years and 50\xa0years old with a median age of 18\xa0years', 'I patients with cognitive impairment']","['MPS', 'Intrathecal enzyme replacement']","['neuropsychological assessment scores', 'pain (injection site, back, groin), headache, neck spasm, and transient blurry vision', 'cognitive impairment']","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1302054', 'cui_str': 'Laronidase'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023786', 'cui_str': 'Mucopolysaccharidosis 1'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision (disorder)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",,0.0169159,"There was no significant effect of intrathecal laronidase on cognitive impairment in older, attenuated MPS","[{'ForeName': 'Agnes H', 'Initials': 'AH', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, Los Angeles Biomedical Institute at Harbor-UCLA, Torrance, CA, United States of America. Electronic address: ahchen@labiomed.org.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harmatz', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA, United States of America.""}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Nestrasil', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN, United States of America.'}, {'ForeName': 'Julie B', 'Initials': 'JB', 'LastName': 'Eisengart', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN, United States of America.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'King', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN, United States of America.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Rudser', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN, United States of America.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Kaizer', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado-Anschutz Medical Campus, Aurora, CO, United States of America.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Svatkova', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wakumoto', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN, United States of America.'}, {'ForeName': 'Steven Q', 'Initials': 'SQ', 'LastName': 'Le', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Madden', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA, United States of America.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Haoyue', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Lynda E', 'Initials': 'LE', 'LastName': 'Polgreen', 'Affiliation': 'Department of Pediatrics, Los Angeles Biomedical Institute at Harbor-UCLA, Torrance, CA, United States of America.'}, {'ForeName': 'Patricia I', 'Initials': 'PI', 'LastName': 'Dickson', 'Affiliation': 'Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, United States of America.'}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2019.11.007']
196,31289334,The effects of exercise session timing on weight loss and components of energy balance: midwest exercise trial 2.,"BACKGROUND/OBJECTIVES


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


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


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


Despite minimal differences in components of energy balance, Early-EX lost significantly more weight compared with Late-Ex. Although the mechanisms are unclear, the timing of exercise may be important for body weight regulation.",2020,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","['Overweight/obese (BMI 25.0-39.9\u2009kg/m 2 ), physically inactive, young adults (~51% female']","['exercise session', 'supervised exercise program (400 or 600\u2009kcal/session for 5 days/week) or served as non-exercise controls (CON', 'CON']","['Total daily energy expenditure (TDEE; doubly labeled water', 'time interaction', 'weight loss', 'Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer', 'change in TDEE, EI, and non-exercise energy expenditure', 'weight loss and components of energy balance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0725595,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","[{'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA. erik.willis@unc.edu.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Creasy', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Honas', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0409-x']
197,31027889,The effect of dry-weight reduction guided by lung ultrasound on ambulatory blood pressure in hemodialysis patients: a randomized controlled trial.,"Approximately 85% of hemodialysis patients are hypertensive, but less than 30% achieve adequate blood pressure (BP) control. Reduction of volume overload is fundamental for BP control, but clinical criteria to estimate dry-weight are inaccurate. In the present study we examined the effect of dry-weight reduction with a lung-ultrasound-guided strategy on ambulatory BP in 71 clinically euvolemic hemodialysis patients with hypertension. Patients were equally randomized into an active group, following a strategy for dry-weight reduction guided by pre-hemodialysis lung ultrasound, and a control group with standard-of-care treatment. All patients underwent 48-hour ambulatory BP monitoring (ABPM) at baseline and after eight weeks. Overall, more patients in the active than in the control group had dry weight reduction, 54.3% compared to 13.9%, respectively. The ultrasonographic-B line change during follow-up was significantly different (-5.3±12.5 in active versus +2.2±7.6 in control group), which corresponded to significant differences in dry weight changes between the groups. The magnitude of reductions in 48-hour systolic BP (-6.61±9.57 vs. -0.67±13.07) and diastolic BP (-3.85±6.34 vs. -0.55±8.28) was significantly greater in the active group. Similarly, intradialytic BP, 44-hour BP, and daytime or night-time systolic/diastolic BP during both days of the interdialytic interval were significantly reduced in the active group but remained unchanged in the control group. The percentage of patients experiencing one or more intradialytic hypotensive episodes was marginally lower in the active group (34.3% vs. 55.6%). Thus, a lung-ultrasound-guided strategy for dry-weight reduction can effectively and safely reduce ambulatory BP levels in hemodialysis patients. Clinical implementation of this simple technique can help increase BP control in this population.",2019,"Overall, more patients in the active than in the control group had dry weight reduction, 54.3% compared to 13.9%, respectively.","['71 clinically euvolemic hemodialysis patients with hypertension', 'hemodialysis patients']","['dry-weight reduction guided by lung ultrasound', 'dry-weight reduction with a lung-ultrasound-guided strategy', '48-hour ambulatory BP monitoring (ABPM', 'strategy for dry-weight reduction guided by pre-hemodialysis lung ultrasound, and a control group with standard-of-care treatment']","['ambulatory BP levels', 'dry weight changes', 'ambulatory blood pressure', 'adequate blood pressure (BP) control', 'percentage of patients experiencing one or more intradialytic hypotensive episodes', 'diastolic BP', 'intradialytic BP, 44-hour BP, and daytime or night-time systolic/diastolic BP during both days of the interdialytic interval', '48-hour systolic BP', 'ultrasonographic-B line change', 'BP control', 'dry weight reduction']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C2709005', 'cui_str': 'Dry body weight (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520541', 'cui_str': 'Hypotensive episode (disorder)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0170317,"Overall, more patients in the active than in the control group had dry weight reduction, 54.3% compared to 13.9%, respectively.","[{'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Loutradis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Pantelis A', 'Initials': 'PA', 'LastName': 'Sarafidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Greece. Electronic address: psarafidis11@yahoo.gr.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ekart', 'Affiliation': 'Department of Nephrology, University Clinical Centre Maribor, Maribor, Slovenia.'}, {'ForeName': 'Christodoulos', 'Initials': 'C', 'LastName': 'Papadopoulos', 'Affiliation': '3rd Department of Cardiology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Sachpekidis', 'Affiliation': 'Department of Cardiology, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Maria Eleni', 'Initials': 'ME', 'LastName': 'Alexandrou', 'Affiliation': 'Department of Nephrology, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'Department of Nephrology, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Giorgos', 'Initials': 'G', 'LastName': 'Efstratiadis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papagianni', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'London', 'Affiliation': 'Hospital and FCRIN INI-CRCTC, Manhes, France.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Zoccali', 'Affiliation': 'CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension, Reggio Calabria, Italy.'}]",Kidney international,['10.1016/j.kint.2019.02.018']
198,32284339,Neurofeedback-Linked Suppression of Cortical β Bursts Speeds Up Movement Initiation in Healthy Motor Control: A Double-Blind Sham-Controlled Study.,"Abnormally increased β bursts in cortical-basal ganglia-thalamic circuits are associated with rigidity and bradykinesia in patients with Parkinson's disease. Increased β bursts detected in the motor cortex have also been associated with longer reaction times (RTs) in healthy participants. Here we further hypothesize that suppressing β bursts through neurofeedback training can improve motor performance in healthy subjects. We conducted a double-blind sham-controlled study on 20 human volunteers (10 females) using a sequential neurofeedback-behavior task with the neurofeedback reflecting the occurrence of β bursts over sensorimotor cortex quantified in real time. The results show that neurofeedback training helps healthy participants learn to volitionally suppress β bursts in the sensorimotor cortex, with training being accompanied by reduced RT in subsequent cued movements. These changes were only significant in the real feedback group but not in the sham group, confirming the effect of neurofeedback training over simple motor imagery. In addition, RTs correlated with the rate and accumulated duration of β bursts in the contralateral motor cortex before the go-cue, but not with averaged β power. The reduced RTs induced by neurofeedback training positively correlated with reduced β bursts across all tested hemispheres. These results strengthen the link between the occurrence of β bursts in the sensorimotor cortex before the go-cue and slowed movement initiation in healthy motor control. The results also highlight the potential benefit of neurofeedback training in facilitating voluntary suppression of β bursts to speed up movement initiation. SIGNIFICANCE STATEMENT  This double-blind sham-controlled study suggested that neurofeedback training can facilitate volitional suppression of β bursts in sensorimotor cortex in healthy motor control better than sham feedback. The training was accompanied by reduced reaction time (RT) in subsequent cued movements, and the reduced RT positively correlated with the level of reduction in cortical β bursts before the go-cue, but not with average β power. These results provide further evidence of a causal link between sensorimotor β bursts and movement initiation and suggest that neurofeedback training could potentially be used to train participants to speed up movement initiation.",2020,"These changes were only significant in the real feedback group but not in the sham group, confirming the effect of neurofeedback training over simple motor imagery.","['healthy subjects', '20 human volunteers (10 females', 'healthy participants', ""patients with Parkinson's disease"", 'healthy motor control']","['neurofeedback training', 'sequential neurofeedback-behaviour task']","['reaction time', 'rigidity and bradykinesia', 'reduced reaction time in subsequent cued movements', 'reduced reaction times', 'motor performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",20.0,0.0558813,"These changes were only significant in the real feedback group but not in the sham group, confirming the effect of neurofeedback training over simple motor imagery.","[{'ForeName': 'Shenghong', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Everest-Phillips', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clouter', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'MRC Brain Network Dynamics Unit at the University of Oxford, United Kingdom Oxford OX1 3TH huiling.tan@ndcn.ox.ac.uk.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.0208-20.2020']
199,31292531,One-year postpartum anthropometric outcomes in mothers and children in the LIFE-Moms lifestyle intervention clinical trials.,"BACKGROUND/OBJECTIVES


Excess gestational weight gain (GWG) is a risk factor for maternal postpartum weight retention and excessive neonatal adiposity, especially in women with overweight or obesity. Whether lifestyle interventions to reduce excess GWG also reduce 12-month maternal postpartum weight retention and infant weight-for-length z score is unknown. Randomized controlled trials from the LIFE-Moms consortium investigated lifestyle interventions that began in pregnancy and tested whether there was benefit through 12 months on maternal postpartum weight retention (i.e., the difference in weight from early pregnancy to 12 months) and infant-weight-for-length z scores.
SUBJECTS/METHODS


In LIFE-Moms, women (N = 1150; 14.1 weeks gestation at enrollment) with overweight or obesity were randomized within each of seven trials to lifestyle intervention or standard care. Individual participant data were combined and analyzed using generalized linear mixed models with trial entered as a random effect. The 12-month assessment was completed by 83% (959/1150) of women and 84% (961/1150) of infants.
RESULTS


Compared with standard care, lifestyle intervention reduced postpartum weight retention (2.2 ± 7.0 vs. 0.7 ± 6.2 kg, respectively; difference of -1.6 kg (95% CI -2.5, -0.7; p = 0.0003); the intervention effect was mediated by reduction in excess GWG, which explained 22% of the effect on postpartum weight retention. Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care. There was no statistically significant treatment group effect on infant anthropometric outcomes at 12 months.
CONCLUSIONS


Compared with standard care, lifestyle interventions initiated in pregnancy and focused on healthy eating, increased physical activity, and other behavioral strategies resulted in significantly less weight retention but similar infant anthropometric outcomes at 12 months postpartum in a large, diverse US population of women with overweight and obesity.",2020,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","['women (N\u2009=\u20091150; 14.1 weeks gestation at enrollment) with overweight or obesity', 'mothers and children in the LIFE-Moms lifestyle intervention clinical trials', 'women with overweight or obesity']","['lifestyle intervention or standard care', 'LIFE-Moms consortium investigated lifestyle interventions']","['maternal postpartum weight retention and infant weight-for-length z score', 'infant anthropometric outcomes', 'weight retention', 'infant-weight-for-length z scores', 'postpartum weight retention', 'maternal postpartum weight retention']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",1150.0,0.182381,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology & Public Health, California Polytechnic State University, San Luis Obispo, CA, USA. sphelan@calpoly.edu.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Clifton', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Haire-Joshu', 'Affiliation': 'Center for Diabetes Translation Research, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Center for Clinical Research and Health Promotion, School of Dental Medicine, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Couch', 'Affiliation': 'Phoenix Indian Medical Center, Indian Health Service, Phoenix, AZ, USA.'}, {'ForeName': 'S Sonia', 'Initials': 'SS', 'LastName': 'Arteaga', 'Affiliation': 'The National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Drews', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan Public Health School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Josefson', 'Affiliation': 'Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Center for Human Nutrition, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'The Miriam Hospital and the Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-019-0410-4']
200,32285318,Random forest for prediction of contrast-induced nephropathy following coronary angiography.,"The majority of prediction models for contrast-induced nephropathy (CIN) have moderate performance. Therefore, we aimed to develop a better pre-procedural prediction tool for CIN following contemporary percutaneous coronary intervention (PCI) or coronary angiography (CAG). A total of 3469 patients undergoing PCI/CAG between January 2010 and December 2013 were randomly divided into a training (n = 2428, 70%) and validation data-sets (n = 1041, 30%). Random forest full models were developed using 40 pre-procedural variables, of which 13 variables were selected for a reduced CIN model. CIN developed in 78 (3.21%) and 37 of patients (3.54%) in the training and validation datasets, respectively. In the validation dataset, the full and reduced models demonstrated improved discrimination over classic Mehran, ACEF CIN risk scores (AUC 0.842 and 0.825 over 0.762 and 0.701, respectively, all P < 0.05) and common estimated glomerular filtration rate. Compared to that for the Mehran risk score model, the full and reduced models had significantly improved fit based on the net reclassification improvement (all P < 0.001) and integrated discrimination improvement (P = 0.001, 0.028, respectively). Using the above models, 2462 (66.7%), 661, and 346 patients were categorized into low (< 1%), moderate (1% to 7%), and high (> 7%) risk groups, respectively. Our pre-procedural CIN risk prediction algorithm (http://cincalc.com) demonstrated good discriminative ability and was well calibrated when validated. Two-thirds of the patients were at low CIN risk, probably needing less peri-procedural preventive strategy; however, the discriminative ability of CIN risk requires further external validation. TRIAL REGISTRATION: ClinicalTrials.gov NCT01400295.",2020,"In the validation dataset, the full and reduced models demonstrated improved discrimination over classic Mehran, ACEF CIN risk scores (AUC 0.842 and 0.825 over 0.762 and 0.701, respectively, all P < 0.05) and common estimated glomerular filtration rate.",['3469 patients undergoing PCI/CAG between January 2010 and December 2013'],['percutaneous coronary intervention (PCI) or coronary angiography (CAG'],"['discrimination over classic Mehran, ACEF CIN risk scores', 'CIN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",3469.0,0.0288732,"In the validation dataset, the full and reduced models demonstrated improved discrimination over classic Mehran, ACEF CIN risk scores (AUC 0.842 and 0.825 over 0.762 and 0.701, respectively, all P < 0.05) and common estimated glomerular filtration rate.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Shiqun', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiology&Dongguan Division of Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Dongguan TCM Hospital, Dongguan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xian', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Xuan', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tan', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jiyan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. chenjiyandr@126.com.""}, {'ForeName': 'Zhonghan', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': ""Department of Cardiology, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, South China University of Technology, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China. liuyongxueshu@139.com.""}]",The international journal of cardiovascular imaging,['10.1007/s10554-019-01730-6']
201,32169479,Short-term effects of stain-causing beverages on tooth bleaching: A randomized controlled clinical trial.,"OBJECTIVES


To evaluate the short-term effects of stain-causing beverages on the effectiveness of in-office tooth bleaching.
METHODS


Participants were recruited and randomly divided into 3 groups based on beverages used for rinsing during and after the bleaching procedure: group N (tap water, control group), group C (coffee), and group T (tea). Participants were instructed to rinse with the respective solutions for 30 s, 4 times daily for 4 weeks. All participants received two in-office bleaching treatment sessions with 40 % hydrogen peroxide (Opalescence BOOST PF 40 %, Ultradent); the sessions were separated by a 1-week interval. Tooth colour was assessed using a spectrophotometer (Easyshade, Vita ZahnFabrik) before the bleaching procedure (T0), immediately after the first session of bleaching (T1), immediately after the second session of bleaching (T2), as well as one week (T3) and three weeks after (T4) the end of bleaching. Tooth sensitivity (TS) was ranked using a numerical rating scale (NRS) and a visual analogue scale (VAS) at different time points.
RESULTS


No significant difference in the whiteness index (W), △E, △a* and △b* values among the 3 groups was observed at any time interval (P for all > 0.05). At T4, the △L* value in group C was significantly lower than that in groups T and N (P = 0.022 and P = 0.001, respectively), though no significant difference in △L* values was observed among the 3 groups at T1 (P = 0.402), T2 (P = 0.643) and T3 (P = 0.177). Additionally, no significant difference was found in the TS values among the 3 groups at any of the evaluation time points (P for all > 0.05).
CONCLUSIONS


Exposure to coffee or tea during the bleaching treatment period did not affect the effectiveness of the treatment. However, exposure to coffee after the bleaching treatment did affect the effectiveness of the treatment. Exposure to stain-causing beverages did not affect the bleaching-induced TS (ClinicalTrials.gov Identifier: NCT03933527).
CLINICAL SIGNIFICANCE


The consumption of coffee or tea during tooth bleaching may not interfere with the colour change produced by the treatment. However, clinicians should advise their patients to refrain from, at least to some extent, consuming coffee after the bleaching procedure to maintain the effectiveness of the treatment.",2020,"No significant difference in the whiteness index (W), △E,","['tooth bleaching', 'Participants']","['Opalescence BOOST', 'stain-causing beverages', 'hydrogen peroxide']","['numerical rating scale (NRS) and a visual analogue scale (VAS', 'TS values', 'Tooth sensitivity (TS', 'whiteness index (W), △E', '△L* values']","[{'cui': 'C0040431', 'cui_str': 'Tooth Whitening'}]","[{'cui': 'C0296695', 'cui_str': 'tooth-bleaching agent, Opalescence'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011432', 'cui_str': 'Tooth Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0249774,"No significant difference in the whiteness index (W), △E,","[{'ForeName': 'Ying-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Laboratory of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Laboratory of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, China.'}, {'ForeName': 'Deng-Wei', 'Initials': 'DW', 'LastName': 'Hong', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Laboratory of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, China.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Attin', 'Affiliation': 'Clinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Fujian Key Laboratory of Oral Diseases & Fujian Provincial Engineering Research Center of Oral Biomaterial & Stomatological Key Laboratory of Fujian College and University, School and Hospital of Stomatology, Fujian Medical University, China; Department of Applied Prosthodontics, Graduate School of Biomedical Sciences, Nagasaki University, Japan. Electronic address: haoyu-cn@hotmail.com.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103318']
202,32200009,"A randomized clinical trial investigating three vital tooth bleaching protocols and associated efficacy, effectiveness and participants' satisfaction.","OBJECTIVES


To compare tooth colour change and participant's satisfaction following: home (HB), in-office (IOB) and combined (CB) bleaching treatments.
METHODS


A group of 105 participants received HB, IOB and CB treatments. HB was performed using custom-made trays and 10 % carbamide peroxide for 14 days. IOB was performed using 37.5 % hydrogen peroxide applied in 3 cycles. CB bleaching treatment involved IOB followed by HB. Tooth colour change was assessed visually (VC-ΔVC) and using a digital spectrophotometry device (ES-ΔeVS). Participant's perception of oral health, smile and straightness and whiteness of teeth were evaluated using self-reported questionnaire. Parameters/responses were evaluated/collected prior bleaching and at recalls. Linear mixed models were used to estimate between- and within-group differences.
RESULTS


CB resulted in significantly higher shade difference at 15 days recall (ΔVC and ΔeVS, all p ≤ 0.046). At 6 months recall, CB group demonstrated higher ΔeVS compared to IOB (p = 0.018) but the difference was not significant between the same groups when using VC (p = 0.051). Significant colour improvement was observed among all groups at 6 months recall (all within-group p < 0.001) except older participants (≥40 years) who received HB (ΔeVS: within-group p = 0.060). Overall, self-perception of oral health and satisfaction with smile and whiteness of teeth were significantly improved in all groups (all within-group p ≤ 0.001). Satisfaction levels with straightness of teeth were significantly improved for CB and IOB overall and in younger (<40 years) participants (all within-group p ≤ 0.013).
CONCLUSION


CB treatment resulted in a pronounced colour improvement when compared to both techniques used individually. All bleaching protocols resulted in significant improvement of participants' perceived oral health and satisfaction with smile and whiteness of teeth.
CLINICAL SIGNIFICANCE


Accelerated whitening can be achieved using a combination of in-office and home bleaching. Patients who may accept gradual whitening of teeth can be treated effectively using a cost-effective protocol and less concentrated bleaching agents.",2020,"All bleaching protocols resulted in significant improvement of participants' perceived oral health and satisfaction with smile and whiteness of teeth.
",[],"['HB, IOB and CB treatments', 'CB bleaching', ' home (HB), in-office (IOB) and combined (CB) bleaching treatments', 'hydrogen peroxide']","['Satisfaction levels', 'IOB', ""Patient's perception of oral health, smile and straightness and whiteness of teeth"", 'Significant colour improvement', 'oral health and satisfaction with smile and whiteness of teeth', 'Overall, self-perception of oral health and satisfaction with smile and whiteness of teeth']",[],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0029162'}, {'cui': 'C0037363', 'cui_str': 'Smilings'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}]",105.0,0.0374345,"All bleaching protocols resulted in significant improvement of participants' perceived oral health and satisfaction with smile and whiteness of teeth.
","[{'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Kothari', 'Affiliation': 'University of Otago, Faculty of Dentistry, 310 Great King Street, Dunedin 9016, New Zealand.'}, {'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': ""Jum'ah"", 'Affiliation': 'Jordan University of Science and Technology, Faculty of Dentistry, Department of Conservative Dentistry, Irbid 22110, Jordan. Electronic address: aajuma@just.edu.jo.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Gray', 'Affiliation': 'University of Otago, Centre for Biostatistics, Division of Health Sciences, 310 Great King Street, Dunedin 9016, New Zealand.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'M Lyons', 'Affiliation': 'University of Otago, Faculty of Dentistry, 310 Great King Street, Dunedin 9016, New Zealand.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yap', 'Affiliation': 'University of Otago, Faculty of Dentistry, 310 Great King Street, Dunedin 9016, New Zealand.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Brunton', 'Affiliation': 'University of Otago, Faculty of Dentistry, 310 Great King Street, Dunedin 9016, New Zealand.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103322']
203,32201201,Proteins from whole mouth saliva mediate greater protection against severe erosive tooth wear than proteins from parotid saliva using an in vitro model.,"OBJECTIVES


to investigate how the composition of the acquired enamel pellicle (AEP) affected a laboratory model of erosive tooth wear (ETW) on human enamel by comparing whole mouth saliva (WMS) to parotid saliva (PS).
METHODS


60 enamel specimens were prepared from extracted human teeth and were randomly assigned to 4 experimental groups: WMS (n = 20), PS (n = 20), artificial saliva (AS, n = 10) and deionised water (DW, n = 10). Following incubation, a subset of WMS (n = 5) and PS (n = 5) groups were used to collect the AEP before the erosive challenge. The rest of the blocks, had their AEP collected after five cycles of acid, wash and saliva and were then assessed for mean step height changes using a non-contacting profilometer (n = 10 each). AEP samples were collected from the enamel specimens by rubbing with filter papers soaked in sodium dodecyl sulfate. Total protein in AEP was quantified using BCA assay, individual protein components of AEP were separated and analysed using SDS-PAGE and western blot for [mucin 5b, albumin, carbonic anhydrase VI (CA VI), statherin]. Specific antibody binding was quantified using purified protein standards of known concentration. Samples of AEP were also analysed by LC/MS/MS sequencing.
RESULTS


WMS group had significantly (p < 0.0001) less acid-induced erosion (step height [4.16 (0.9) μm]) than PS group [6.41 (0.3) μm]. The amount of total protein, mucin 5b and albumin were more dominant in WMS pellicles than PS (p < 0.0001) whereas CA VI and statherin were dominant in PS pellicles (p < 0.0001).
CONCLUSION


The composition of the acquired enamel pellicle influences the degree of protection from acid attack, possibly by altering the mechanism of protection. The in-vitro model used in this study was severe enough to cause tissue loss as opposed to just softening of the surface structure. AEP from WMS was more protective than that of PS, and its likely mechanisms of protection seem to be as a physical barrier rather than stabilising the crystal structure.
SIGNIFICANCE


The protective salivary proteins against in-vitro erosion models differ from in-vivo studies. Therfore, it can be recommended that in-vitro laboratory models of ETW need to be assessed carefully to represent the clinical environment more closely.",2020,"RESULTS


WMS group had significantly (p < 0.0001) less acid-induced erosion (step height [4.16 (0.9) μm]) than PS group [6.41 (0.3) μm].",['60 enamel specimens were prepared from extracted human teeth'],"['sodium dodecyl sulfate', 'WMS']","['CA VI and statherin', 'Total protein in AEP', 'amount of total protein, mucin5b and albumin']","[{'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C0037506', 'cui_str': 'sodium lauryl sulfate'}]","[{'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}]",,0.0347642,"RESULTS


WMS group had significantly (p < 0.0001) less acid-induced erosion (step height [4.16 (0.9) μm]) than PS group [6.41 (0.3) μm].","[{'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Mutahar', 'Affiliation': ""Salivary Research, Centre for Host-Microbe Interaction, King's College London Dental Institute, London Bridge SE1 9RT, United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': ""Centre for Oral Clinical and Translational Sciences, King's College London Dental Institute, London Bridge SE1 9RT, United Kingdom.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Carpenter', 'Affiliation': ""Salivary Research, Centre for Host-Microbe Interaction, King's College London Dental Institute, London Bridge SE1 9RT, United Kingdom. Electronic address: Guy.Carpenter@kcl.ac.uk.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Moazzez', 'Affiliation': ""Centre for Oral Clinical and Translational Sciences, King's College London Dental Institute, London Bridge SE1 9RT, United Kingdom.""}]",Journal of dentistry,['10.1016/j.jdent.2020.103319']
204,31229621,Health coaching to encourage obese adults to enroll in commercially-available weight management programs: The path to health study.,"Physicians are recommended to screen and refer obese patients to weight management programs (WMPs). There are often limited referral options for physicians, though commercially-available WMPs could be a potential solution. The purpose of this study (Path to Health) was to evaluate the efficacy of health coaching to promote enrollment in commercially-available WMPs through a two-arm, RCT with obese patients (n = 168) randomly assigned to intervention (n = 84) or control groups (n = 84). Intervention participants received phone health coaching to help them select and enroll in WMPs. We collected data on program enrollment, weight, self-reported physical activity (PA), and fruit and vegetable (FV) intake at baseline, 3- and 6-months. We used logistic regression to assess the intervention effect on enrollment in WMPs and longitudinal regression models to evaluate the effect on weight change, PA and FV intake. The average age was 54.7 years, 59% were female and 43% were Black and 49% were White. At 6 months, 39% of the intervention group (vs. 29% of control) had enrolled in WMPs. We found no longitudinal intervention effect on weight, PA and FV intake. We found that there was more weight loss for those who completed ≥4 calls as compared to those who completed <4 calls. We also found significant dose response relationships for PA and FV intake at 3 months. In this study, we found that phone health coaching was successful in increasing obese adults' enrollment in commercially-available WMPs and that there was a dose response relationship for weight and behavioral outcomes.",2019,We found that there was more weight loss for those who completed ≥4 calls as compared to those who completed <4 calls.,"['obese patients (n\u202f=\u202f168) randomly assigned to intervention (n\u202f=\u202f84) or control groups (n\u202f=\u202f84', 'The average age was 54.7\u202fyears, 59% were female and 43% were Black and 49% were White']","['Health coaching', 'health coaching', 'phone health coaching to help them select and enroll in WMPs', 'phone health coaching']","['weight loss', 'weight, PA and FV intake', 'WMPs', 'weight, self-reported physical activity (PA), and fruit and vegetable (FV) intake', 'weight change, PA and FV intake']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",168.0,0.0245321,We found that there was more weight loss for those who completed ≥4 calls as compared to those who completed <4 calls.,"[{'ForeName': 'Natalia I', 'Initials': 'NI', 'LastName': 'Heredia', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Health Disparities Research, 1400 Pressler St, Houston, TX 77030, United States. Electronic address: niheredia@mdanderson.org.'}, {'ForeName': 'MinJae', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'McGovern Medical School at The University of Texas Health Science Center at Houston, United States.'}, {'ForeName': 'Kevin O', 'Initials': 'KO', 'LastName': 'Hwang', 'Affiliation': 'McGovern Medical School at The University of Texas Health Science Center at Houston, United States.'}, {'ForeName': 'Belinda M', 'Initials': 'BM', 'LastName': 'Reininger', 'Affiliation': 'The University of Texas Health Science Center Houston, School of Public Health in Brownsville, United States.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Fernandez', 'Affiliation': 'The University of Texas Health Science Center at Houston, School of Public Health, United States.'}, {'ForeName': 'Lorna H', 'Initials': 'LH', 'LastName': 'McNeill', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Health Disparities Research, 1400 Pressler St, Houston, TX 77030, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.06.006']
205,32038035,Impact of a Novel Hypothermia Alert Device on Death of Low Birthweight Babies at Four Weeks: A Non-randomized Controlled Community-based Trial.,"OBJECTIVE


To study the effectiveness of a hypothermia monitoring device in reducing neonatal mortality and increasing Kangaroo Mother Care compliance.
DESIGN


Non-randomized controlled trial.
SETTING


3 government Sick Newborn Care Units and 7 Primary Health Centers in Udaipur and Dungarpur districts of Rajasthan for 4 months. The follow-up period was 4 weeks for each baby.
PARTICIPANTS


Total 386 neonates were included in the study. 250 (64.76%) new-borns in the study group (BEMPU bracelet) and 136 (35.23%) enrolled in the control group. Clinically stable babies discharged below 2500 grams, whose parents could be reached by phone, and who could visit the facility for 4 weekly follow-ups were eligible for participation. Infants with complications or those leaving against medical advice were not eligible.
INTERVENTION


The BEMPU Bracelet is a medical device that provides 4 weeks of continuous hypothermia monitoring for new-borns, and emits an audio-visual alarm when the temperature of the newborn is below 36.5°C.
OUTCOME


Neonatal mortality over the 4-week period.
RESULTS


Mortality data was obtained for 92% (229 babies) of the study group and 91% of the control group (124 babies) at the end of the 4-week period. The intervention group had a significantly lower mortality rate as compared to the control group (6% vs. 14%, P=0.013). Weight data from 51% of the study group (128 babies) and 32% of the control group (44 babies) did not show a significant difference in weight gain between the groups.
CONCLUSIONS


The observed effect on mortality and qualitative feedback on KMC compliance suggest the utility of the device in the community settings.",2020,"The intervention group had a significantly lower mortality rate as compared to the control group (6% vs. 14%, P=0.013).","['3 government Sick Newborn Care Units and 7 Primary Health Centers in Udaipur and Dungarpur districts of Rajasthan for 4 months', 'Death of Low Birthweight Babies at Four Weeks', 'Infants with complications or those leaving against medical advice were not eligible', 'Total 386 neonates were included in the study']","['Novel Hypothermia Alert Device', 'hypothermia monitoring device']","['Weight data', 'Neonatal mortality', 'mortality rate', 'weight gain', 'Mortality data', 'neonatal mortality and increasing Kangaroo Mother Care compliance']","[{'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0204792', 'cui_str': 'Newborn health care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2919670', 'cui_str': 'Left against medical advice (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",386.0,0.0301979,"The intervention group had a significantly lower mortality rate as compared to the control group (6% vs. 14%, P=0.013).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'BEMPU Health, Bengaluru, Karnataka, India. Correspondence to: Dr Mona Sharma, Head of Product Design and Customer Research, BEMPU Health, 3C Alsa Glenridge Apt, 32, Langford Rd, Shanti Nagar, Bengaluru, Karnataka 560 027, India. mona@bempu.com.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Morgan', 'Affiliation': 'BEMPU Health, Bengaluru, Karnataka, India.'}, {'ForeName': 'Murthy', 'Initials': 'M', 'LastName': 'Siddadiah', 'Affiliation': 'BEMPU Health, Bengaluru, Karnataka, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Songara', 'Affiliation': 'The Wadhwani Initiative for Sustainable Healthcare (WISH Foundation), Jaipur, Rajasthan, India.'}, {'ForeName': 'Rahul Dev', 'Initials': 'RD', 'LastName': 'Bhawsar', 'Affiliation': 'The Wadhwani Initiative for Sustainable Healthcare (WISH Foundation), Jaipur, Rajasthan, India.'}, {'ForeName': 'Ambey', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'The Wadhwani Initiative for Sustainable Healthcare (WISH Foundation), Jaipur, Rajasthan, India.'}]",Indian pediatrics,[]
206,31538907,Effect of Curcumin on Serum Cathepsin D in Patients with Metabolic Syndrome.,"BACKGROUND


Inflammation has been shown to accompany Metabolic Syndrome (MetS) and its features. Cathepsin D is one of a proinflammatory mediator. In the current study, we aimed to investigate the effect of curcumin supplementation on serum cathepsin D levels in patients with MetS.
METHODS


The current study was conducted on 18-65 years old individuals with MetS diagnosed according to the International Diabetes Federation guidelines. A total of 80 participants were randomly divided into treatment and control groups. The first group (n=40) was given 2 capsules containing 500 mg of phosphatidylcholine complex of curcumin, and the other group (n=40) was given two 500 mg placebo capsules for 6 weeks. Before (week 0) and after (week 6) the intervention, anthropometric indices and blood pressure were measured and blood samples were taken. Serum cathepsin D was measured using an ELISA kit.
RESULTS


There was no significant difference between treatment and control groups in terms of weight, body mass index, waist circumference and serum cathepsin D levels before and after the intervention. In addition, there was no significant difference between pre- and post-trial values of serum cathepsin D.
CONCLUSION


The present results do not suggest any effect of curcumin on cathepsin D levels in patients with MetS.",2020,"There were no significant differences between treatment and control groups in regard to weight, BMI, waist circumference and serum cathepsin D levels before and after the intervention.","['A total of 80 participants', '18-65 years old individuals with MetS according to the criteria of &quot;IDF&quot; guidelines', 'Patients with Metabolic Syndrome', 'patients with MetS']","['Curcumin', 'Cathepsin D', 'curcumin', '2 capsules containing 500mg of phosphatidylcholine complex of curcumin, and the other group (n=40) were given two 500mg capsules contain lactose as placebo']","['serum cathepsin D', 'Serum cathepsin D', 'weight, BMI, waist circumference and serum cathepsin D levels', 'anthropometric indices and blood pressure', 'cathepsin D level', 'Serum Cathepsin D']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0007427', 'cui_str': 'Cathepsin D (substance)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1959616', 'cui_str': 'Phosphatidyl Cholines'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007427', 'cui_str': 'Cathepsin D (substance)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",80.0,0.0224018,"There were no significant differences between treatment and control groups in regard to weight, BMI, waist circumference and serum cathepsin D levels before and after the intervention.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Shirmohammadi', 'Affiliation': 'School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghayour-Mobarhan', 'Affiliation': 'Metabolic Syndrome Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saberi-Karimian', 'Affiliation': 'Student Research Committee, Iranian UNESCO Center of Excellence for Human Nutrition, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Iranshahi', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Tavallaie', 'Affiliation': 'Metabolic Syndrome Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Emamian', 'Affiliation': 'Metabolic Syndrome Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Halal Research Center of IRI, FDA, Tehran, Iran.'}]",Cardiovascular & hematological disorders drug targets,['10.2174/1871529X19666190919110652']
207,32282342,Comparative Evaluation of Participation and Diagnostic Yield of Colonoscopy vs Fecal Immunochemical Test vs Risk-Adapted Screening in Colorectal Cancer Screening: Interim Analysis of a Multicenter Randomized Controlled Trial (TARGET-C).,"INTRODUCTION


In colorectal cancer screening, implementing risk-adapted screening might be more effective than traditional screening strategies. We aimed to compare the effectiveness of a risk-adapted screening strategy with colonoscopy and fecal immunochemical test (FIT) in colorectal cancer screening.
METHODS


A randomized controlled trial was conducted in 6 centers in China since May 2018. Nineteen thousand five hundred forty-six eligible participants aged 50-74 years were recruited and randomly allocated into 1 of the 3 screening groups in a 1:2:2 ratio: (i) one-time colonoscopy (n = 3,916), (ii) annual FIT (n = 7,854), and (iii) annual risk-adapted screening (n = 7,776). Based on the risk-stratification score, high-risk subjects were referred for colonoscopy and low-risk ones were referred for FIT. All subjects with positive FIT were referred for diagnostic colonoscopy. The detection rate of advanced neoplasm was the primary outcome. The study is registered with the China Clinical Trial Registry (www.chictr.org.cn Identifier: ChiCTR1800015506).
RESULTS


For baseline screening, the participation rates of the colonoscopy, FIT, and risk-adapted screening groups were 42.5% (1,665/3,916), 94.0% (7,386/7,854), and 85.2% (6,628/7,776), respectively. For the intention-to-screen analysis, the detection rates of advanced neoplasm were 2.40% (94/3,916), 1.13% (89/7,854), and 1.66% (129/7,776), with odds ratios (95% confidence intervals) of 2.16 (1.61-2.90; P < 0.001) for colonoscopy vs FIT, 1.45 (1.10-1.90; P < 0.001) for colonoscopy vs risk-adapted screening, and 1.49 (1.13-1.97; P < 0.001) for risk-adapted screening vs FIT, respectively. The numbers of subjects who required a colonoscopic examination to detect 1 advanced neoplasm were 18 in the colonoscopy group, 10 in the FIT group, and 11 in the risk-adapted screening group.
DISCUSSION


For baseline screening, the risk-adapted screening approach showed a high participation rate, and its diagnostic yield was superior to that of FIT at a similarly low load of colonoscopy.",2020,"DISCUSSION


For baseline screening, the risk-adapted screening approach showed a high participation rate, and its diagnostic yield was superior to that of FIT at a similarly low load of colonoscopy.","['Colorectal Cancer Screening', 'colorectal cancer screening', 'Nineteen thousand five hundred forty-six eligible participants aged 50-74 years', '6 centers in China since May 2018', 'All subjects with positive FIT were referred for diagnostic colonoscopy']","['risk-adapted screening strategy with colonoscopy and fecal immunochemical test (FIT', 'Colonoscopy vs Fecal Immunochemical Test vs Risk-Adapted Screening']","['detection rate of advanced neoplasm', 'detection rates of advanced neoplasm']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0400018', 'cui_str': 'Diagnostic endoscopic examination on colon'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",19546.0,0.122397,"DISCUSSION


For baseline screening, the risk-adapted screening approach showed a high participation rate, and its diagnostic yield was superior to that of FIT at a similarly low load of colonoscopy.","[{'ForeName': 'Hongda', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuangmei', 'Initials': 'S', 'LastName': 'Zou', 'Affiliation': 'Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lingbin', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Department of Cancer Prevention, Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences/Cancer Hospital of University of Chinese Academy of Sciences/Zhejiang Cancer Hospital.'}, {'ForeName': 'Xianzhen', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': 'Department of Cancer Prevention, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'Office of Cancer Prevention and Treatment, Xuzhou Cancer Hospital, Xuzhou, China.'}, {'ForeName': 'Donghua', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': 'Department of Cancer Prevention, Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Colorectal Surgery, Tumor Hospital of Yunnan Province/Third Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Cancer Prevention, Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences/Cancer Hospital of University of Chinese Academy of Sciences/Zhejiang Cancer Hospital.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer and Basic Medicine (ICBM), Chinese Academy of Sciences/Cancer Hospital of University of Chinese Academy of Sciences/Zhejiang Cancer Hospital.'}, {'ForeName': 'Weifang', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Proctology, Lanxi Red Cross Hospital, Jinhua, China.'}, {'ForeName': 'Haifan', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Cancer Prevention, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Yunxin', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Office of Cancer Prevention and Treatment, Xuzhou Cancer Hospital, Xuzhou, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Department of Cancer Prevention, Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Administrative Management Office of Yunan Cancer Center, Yunnan Cancer Hospital/The Third Affiliated Hospital of Kunming Medical University/Yunnan Cancer Center, Kunming, China.'}, {'ForeName': 'Rongbiao', 'Initials': 'R', 'LastName': 'Ying', 'Affiliation': 'Department of Surgical Oncology, Taizhou Cancer Hospital, Taizhou, China.'}, {'ForeName': 'Baoquan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Public Health, Lanxi Red Cross Hospital, Jinhua, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cancer Prevention, Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Xiaopeng', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of NCD Prevention and Heath Education, Hefei Center for Disease Control and Prevention, Hefei, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Cancer Prevention, Tumor Hospital of Yunnan Province/Third Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Colorectal Surgery, Tumor Hospital of Yunnan Province/Third Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Yuhan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lanwei', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Henan Office for Cancer Control and Research, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, and the Ministry of Education Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jiansong', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jufang', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Miao', 'Affiliation': 'Department of Epidemiology and Biostatistics, and the Ministry of Education Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Brenner', 'Affiliation': 'Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Dai', 'Affiliation': 'Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000624']
208,31238172,Embedding caregiver support in community-based services for older adults: A multi-site randomized trial to test the Adult Day Service Plus Program (ADS Plus).,"There are over five million people in the United States living with dementia. Most live at home and are cared for by family. These family caregivers often assume care responsibilities without education about the disease, skills training, or support, and in turn become at risk for depression, burden, and adverse health outcomes when compared to non-dementia caregivers. Despite over 200 caregiver interventions with proven benefits, many caregivers lack access to these programs. One approach to enhance access is to embed evidence-based caregiver support programs in existing community-based services for people with dementia such as adult day services (ADS). Here we describe the protocol for an embedded pragmatic trial designed to augment standard ADS known as ADS Plus. ADS Plus provides family caregivers with support via education, referrals, and problem-solving techniques over 12 months, and is delivered on-site by existing ADS staff. Embedding a program in ADS requires an understanding of outcomes and implementation processes in that specific context. Thus, we deploy a hybrid design involving a cluster randomized two-group trial to evaluate treatment effects on caregiver wellbeing, ADS utilization, as well as nursing home placement. We describe implementation practices in 30 to 50 geographically and racially/ethnically diverse participating sites. Clinical trial registration #: NCT02927821.",2019,Here we describe the protocol for an embedded pragmatic trial designed to augment standard ADS known as ADS,"['30 geographically and racially/ethnically diverse participating sites', 'people with dementia such as adult day services (ADS', 'older adults']","['standard ADS known as ADS', 'ADS']","['caregiver wellbeing, ADS utilization']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.147567,Here we describe the protocol for an embedded pragmatic trial designed to augment standard ADS known as ADS,"[{'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'Drexel University, 1601 Cherry Street, 10th Floor, Room 1092, Philadelphia, PA 19102, United States of America. Electronic address: Lng45@drexel.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Marx', 'Affiliation': 'Johns Hopkins School of Nursing, Center for Innovative Care in Aging, 901 N. Broadway, Room 214, Baltimore, MD 21205, United States of America. Electronic address: kmarx1@jhu.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Scerpella', 'Affiliation': 'Johns Hopkins School of Nursing, Center for Innovative Care in Aging, 901 North Broadway, 2nd Floor, Baltimore, MD 21205, United States of America. Electronic address: dscerpe1@jhu.edu.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Dabelko-Schoeny', 'Affiliation': 'College of Social Work, 207 Stillman Hall, 1947 College Rd N., Columbus, OH 43210, United States of America. Electronic address: dabelko-schoeny.1@csw.osu.edu.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Anderson', 'Affiliation': 'University of Montana, School of Social Work, 014 Jeannette Rankin Hall, 32 Campus Drive, Missoula, MT 59812-4392, United States of America. Electronic address: keith.anderson@mso.umt.edu.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Johns Hopkins School of Medicine, Center on Aging and Health, 2024 East Monument Street, Baltimore, MD 21205, United States of America. Electronic address: j.huang@jhu.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pizzi', 'Affiliation': 'University Ernest Mario School of Pharmacy, Center for Health Outcomes, Policy, and Economics, 160 Frelinghuysen Road - Suite 417, Piscataway, NJ 08854, United States of America. Electronic address: laura.pizzi@rutgers.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Jutkowitz', 'Affiliation': 'Brown University School of Public Health, Department of Health Services, Policy & Practice, BoxG-S121 (6), 121 S Main Street, Providence, RI 02912, United States of America. Electronic address: jutkowitz@brown.edu.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Johns Hopkins School of Medicine, Center on Aging and Health, 2024 East Monument Street, Baltimore, MD 21205, United States of America. Electronic address: droth@jhu.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Gaugler', 'Affiliation': 'University of Minnesota, School of Nursing, 308 SE Harvard St, Minneapolis, MN 55455, United States of America. Electronic address: gaug0015@umn.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.06.010']
209,31876200,Methotrexate pharmacokinetic is influenced by co-administration of cyclosporin in rheumatoid arthritis patients. Results from a randomized clinical trial.,"The aim was to investigate if the pharmacokinetics of methotrexate (MTX) are affected by the addition of cyclosporin (CsA). Forty patients diagnosed with early rheumatoid arthritis (RA) were included in this open prospective study: 20 patients were treated with a dose of 7.5 mg MTX and a dose of 2.5 mg/kg CsA, 20 patients were treated with a dose of 7.5 mg MTX and placebo. Baseline measurements of plasma MTX and erythrocyte MTX were made. Area under the plasma concentration versus time curve (AUC) and other pharmacokinetic variables were estimated by means of a population based software model. Clinical improvement of 20-50-70% according to the American College of Rheumatology (ACR) and adverse events were evaluated ongoing for 52 weeks. We found that mean peak plasma MTX concentration was significantly higher in the MTX + CsA combination treatment group ( p  = .003). No differences in AUC, erythrocyte MTX or other pharmacokinetic parameters were found between the two treatment groups. Estimated Glomerular Filtration Rate (eGFR) decreased significantly in the MTX + CsA treatment group ( p  < .001), but no serious adverse events occurred in either of the two groups. In conclusion, CsA added to methotrexate treatment in early RA significantly increased peak-plasma MTX concentration, but other pharmacokinetic parameters and measurements of MTX were unchanged.",2020,"Estimated Glomerular Filtration Rate (eGFR) decreased significantly in the MTX + CsA treatment group ( p  < .001), but no serious adverse events occurred in either of the two groups.","['rheumatoid arthritis patients', 'Forty patients diagnosed with early rheumatoid arthritis (RA']","['cyclosporin (CsA', 'MTX\u2009+\u2009CsA', 'cyclosporin', 'methotrexate (MTX', 'MTX and placebo', 'MTX', 'methotrexate']","['plasma concentration versus time curve (AUC) and other pharmacokinetic variables', 'AUC, erythrocyte MTX or other pharmacokinetic parameters', 'American College of Rheumatology (ACR) and adverse events', 'mean peak plasma MTX concentration', 'serious adverse events', 'peak-plasma MTX concentration', 'Estimated Glomerular Filtration Rate (eGFR']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C3811844'}]",40.0,0.0915584,"Estimated Glomerular Filtration Rate (eGFR) decreased significantly in the MTX + CsA treatment group ( p  < .001), but no serious adverse events occurred in either of the two groups.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Odderskov', 'Affiliation': 'Department of Clinical Biochemistry, Regional Hospital Randers, Randers, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Stengaard-Pedersen', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Torkell', 'Initials': 'T', 'LastName': 'Ellingsen', 'Affiliation': 'Rheumatology Research Unit, Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Nete', 'Initials': 'N', 'LastName': 'Hornung', 'Affiliation': 'Department of Clinical Biochemistry, Regional Hospital West Jutland, Holstebro, Denmark.'}]",Scandinavian journal of clinical and laboratory investigation,['10.1080/00365513.2019.1706190']
210,32252716,Impact of front-of-pack nutrition labels on consumer purchasing intentions: a randomized experiment in low- and middle-income Mexican adults.,"BACKGROUND


Front-of-pack (FOP) nutrition labeling is a cost-effective strategy to help consumers make informed and healthier food choices. We aimed to investigate the effect of the FOP labels used in the Latin American region on consumers' shopping intentions when prompted to make their choices with specific nutrients-to-limit in mind among low- and middle-income Mexican adults (> 18 y).
METHODS


In this experimental study of an online simulated shopping situation participants (n = 2194) were randomly assigned to one of three labeling conditions: Guideline Daily Amounts (GDA), Multiple Traffic Lights (MTL), or red Warning Labels (WL). Participants were required to view a video explaining how to correctly interpret the assigned label. Primary outcomes were the overall nutritional quality (estimated using the Nutrient Profiling Scoring Criterion [NPSC] and NPSC baseline score) and mean energy and nutrient content of purchases. Secondary outcomes included shopping time variables. We also evaluated the impact of the labels across food categories (ready-made foods, dairy beverages, non-dairy beverages, salty snacks, and breakfast cereals) and sociodemographic subgroups.
RESULTS


The MTL and the WL led to a better overall nutritional quality of the shopping cart compared to the GDA (p < 0.05). According to the NPSC score, the WL led to a better nutritional quality across breakfast cereals and salty snacks compared to the GDA (p < 0.05); a similar effect was observed for the MTL among non-dairy beverages (p < 0.05). The MTL and the WL required shorter shopping times compared to GDA (p < 0.05). Across all labeling conditions, the nutritional quality of the shopping cart tended to be lower among those with low income, education and nutrition knowledge levels.
CONCLUSION


WL and MTL may foster healthier food choices in a faster way among low- and middle-income groups in Mexico. To produce an equitable impact among consumers of all socioeconomic strata, efforts beyond simply the inclusion of a communication campaign on how to use and interpret FOP labels will be required.
TRIAL REGISTRATION


clinicaltrials.gov. NCT04308408 Retrospectively registered March 16, 2020.",2020,The MTL and the WL required shorter shopping times compared to GDA (p < 0.05).,"['low- and middle-income Mexican adults (>\u200918 y', 'low- and middle-income Mexican adults', 'participants (n\u2009=\u20092194']","['Guideline Daily Amounts (GDA), Multiple Traffic Lights (MTL), or red Warning Labels (WL', 'front-of-pack nutrition labels', 'FOP labels', 'online simulated shopping situation', 'WL and MTL']","['nutritional quality across breakfast cereals and salty snacks', 'overall nutritional quality', 'overall nutritional quality (estimated using the Nutrient Profiling Scoring Criterion [NPSC] and NPSC baseline score) and mean energy and nutrient content of purchases', 'consumer purchasing intentions']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0016037', 'cui_str': 'Progressive myositis ossificans'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}]","[{'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",2194.0,0.0708142,The MTL and the WL required shorter shopping times compared to GDA (p < 0.05).,"[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Jáuregui', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col. Santa María Ahuacatitlán, CP. 62100, Cuernavaca, Morelos, Mexico. alejandra.jauregui@insp.mx.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Vargas-Meza', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col. Santa María Ahuacatitlán, CP. 62100, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Nieto', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col. Santa María Ahuacatitlán, CP. 62100, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Contreras-Manzano', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col. Santa María Ahuacatitlán, CP. 62100, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Nelson Zacarías', 'Initials': 'NZ', 'LastName': 'Alejandro', 'Affiliation': 'School of Public Health, Mexican National Institute of Public Health, Av. Universidad 655 Col. Santa María Ahuacatitlán, CP. 62100, Cuernavaca, Mexico.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Tolentino-Mayo', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col. Santa María Ahuacatitlán, CP. 62100, Cuernavaca, Morelos, Mexico.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, USA.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, Mexican National Institute of Public Health, Av. Universidad 655 Col. Santa María Ahuacatitlán, CP. 62100, Cuernavaca, Morelos, Mexico.'}]",BMC public health,['10.1186/s12889-020-08549-0']
211,31266440,Safety and Efficacy of Universal Postoperative Decolonization for Kidney Transplant Recipients.,"OBJECTIVES


Infection is a common cause of morbidity and mortality after kidney transplant. Based on the well-documented successes of reducing infections with decolonization of patients in intensive care units, we began a universal immediate posttransplant decolonization program for all kidney transplant recipients. Herein, we report safety and efficacy of this decolonization program.
MATERIALS AND METHODS


We compared a consecutive cohort of kidney transplant recipients who underwent universal decolonization (intervention group) with a cohort of transplant patients from an era immediately prior to this practice (control group). Universal decolonization included daily chlorhexidine body wash and nasal mupirocin ointment.
RESULTS


Seventy-eight patients who underwent universal decolonization were compared with 43 patients in the control group. Ten microbiologically proven infections (8.3%) occurred in the 30 days after discharge: 7 (9%) in the intervention group and 3 (7%) in the control group. Forty-five transplant recipients (37.2%) were readmitted in the 30 days after discharge: 31 (39.7%) in the intervention group and 14 (32.6%) in the control group. No patients in the intervention group had adverse drug events from mupirocin and chlorhexidine use.
CONCLUSIONS


A universal decolonization protocol was successfully implemented and was well tolerated by all patients. Despite successful implementation, we did not observe any significant differences in infection rates between treated patients and historical controls.",2020,"No patients in the intervention group had adverse drug events from mupirocin and chlorhexidine use.
","['We compared a consecutive cohort of kidney transplant recipients who underwent universal decolonization (intervention group) with a cohort of transplant patients from an era immediately prior to this practice (control group', 'Kidney Transplant Recipients', 'kidney transplant', 'kidney transplant recipients']","['chlorhexidine', 'chlorhexidine body wash and nasal mupirocin ointment', 'Universal Postoperative Decolonization']","['infection rates', 'adverse drug events', 'Safety and Efficacy']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",78.0,0.041526,"No patients in the intervention group had adverse drug events from mupirocin and chlorhexidine use.
","[{'ForeName': 'Dong Heun', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'From the Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Malat', 'Affiliation': ''}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Boyle', 'Affiliation': ''}, {'ForeName': 'Sindhura', 'Initials': 'S', 'LastName': 'Talluri', 'Affiliation': ''}, {'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Bias', 'Affiliation': ''}, {'ForeName': 'Meera N', 'Initials': 'MN', 'LastName': 'Harhay', 'Affiliation': ''}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ranganna', 'Affiliation': ''}, {'ForeName': 'Alden', 'Initials': 'A', 'LastName': 'Doyle', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2018.0341']
212,31353275,Using Interactive Nutrition Modules to Increase Critical Thinking Skills in College Courses.,"OBJECTIVE


To understand how the addition of an evidence-based framework to an online nutrition module influences college students' critical thinking decision making (CT-DM).
DESIGN


Students were individually randomized into an intervention group or a control group. The nutrition modules focused on 2 topics related to different types of eating behavior. Students completed a CT-DM activity to generate a score.
PARTICIPANTS


College students, between 18 and 24 years old, recruited from introductory nutrition and agriculture science courses at 2 universities.
INTERVENTION


Intervention and control received 2 nutrition modules. The intervention added a CT-DM framework that framed the topic as a problem, incorporated activities, and provided scaffolding.
MAIN OUTCOME MEASURES


CT-DM was scored using a validated rubric to assess the use of critical thinking skills when making a food-related decision. Green eating and critical thinking disposition were measured.
ANALYSIS


Hierarchical linear regression and t tests were used to assess outcomes.
RESULTS


A total of 431 students participated (intervention = 203; control = 228). After controlling for university, the intervention group scored significantly higher on CT-DM (18.1 ± 7.6) compared with the control (15.4 ± 8.4); F (3,428) = 14.58, P < .001.
CONCLUSIONS AND IMPLICATIONS


The results show that an evidence-based framework using nutrition topics encourages CT-DM skills. Future higher-education nutrition interventions should use frameworks to enhance student learning.",2020,"After controlling for university, the intervention group scored significantly higher on CT-DM (18.1 ± 7.6) compared with the control (15.4 ± 8.4); F (3,428) = 14.58, P < .001.
","['Students', 'College students, between 18 and 24 years old, recruited from introductory nutrition and agriculture science courses at 2 universities', '431 students participated (intervention\u202f=\u202f203; control\u202f=\u202f228', 'College Courses']","['Interactive Nutrition Modules', 'Intervention and control received 2 nutrition modules']","['critical thinking skills', 'CT-DM activity', 'Green eating and critical thinking disposition', 'CT-DM']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}]",,0.0722239,"After controlling for university, the intervention group scored significantly higher on CT-DM (18.1 ± 7.6) compared with the control (15.4 ± 8.4); F (3,428) = 14.58, P < .001.
","[{'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'McNamara', 'Affiliation': 'School of Food and Agriculture, University of Maine, Orono, ME. Electronic address: jade.mcnamara@maine.edu.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sweetman', 'Affiliation': 'School of Education, University of Rhode Island, Kingston, RI.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Connors', 'Affiliation': 'College of Merchandizing, Hospitality and Tourism, University of Northern Texas, Denton, TX.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Lofgren', 'Affiliation': 'Department of Nutrition and Food Science, University of Rhode Island, Kingston, RI.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Greene', 'Affiliation': 'Department of Nutrition and Food Science, University of Rhode Island, Kingston, RI.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.06.007']
213,31897548,Safety and efficacy of matrix-associated autologous chondrocyte implantation with spheroid technology is independent of spheroid dose after 4 years.,"PURPOSE


The aim of this study was to investigate the effect of product dose in autologous chondrocyte implantation (ACI) for the treatment of full-thickness cartilage defects of the knee and to assess its influence on clinical and morphological mid-term outcome.
METHODS


Seventy-five patients were included in this single-blind, randomised, prospective, controlled clinical trial. Patients were assigned randomly to three different dose groups [low (3-7 spheroids/cm 2 ), medium (10-30 spheroids/cm 2 ), or high (40-70 spheroids/cm 2 )] and assessed using standardised clinical and morphological scoring systems (KOOS, IKDC, MOCART) for 4 years following the intervention.
RESULTS


The analysis population comprised 75 patients (22 women, 53 men) aged 34 ± 9 years. Defect sizes ranged from 2 to 10 cm 2  following intraoperative debridement. The assessment of the primary variable 'overall KOOS' showed a statistically significant improvement, compared with baseline, for each dose group, i.e., at baseline the mean 'overall KOOS' scores were 60.4 ± 13.6, 59.6 ± 15.4, and 51.1 ± 15.4 for the low-, medium-, and high-dose groups, respectively, and 57.0 ± 15.2 for 'all patients'. After 48 months those values improved to 80.0 ± 14.7, 84.0 ± 14.9, and 66.9 ± 21.5 in the respective dose groups and 77.1 ± 18.6 for 'all patients'. Pairwise comparisons of these dose groups did not reveal any statistically significant differences. Likewise, assessment of the subjective IKDC score revealed no statistically significant differences between the three dose groups up to the 48-month visit. However, between 12 and 48 months there was a low, but steady, improvement in the low-dose group and a substantial amelioration in the medium-dose group. The mean MOCART total scores 3 months after treatment were 59.8 ± 10.9, 64.5 ± 10.3, and 64.7 ± 9.4 for the low-, medium-, and high-dose groups, and 62.9 ± 10.3 for 'all patients'; 48 months after treatment these were 73.9 ± 13.1, 78.0 ± 12.4, and 74.3 ± 14.0 for the respective dose groups and 75.5 ± 13.1 for 'all patients'.
CONCLUSIONS


Results of this study confirm the efficacy and safety of the applied ""advanced therapy medicinal product""; no dose dependence was found either for the incidence or for the severity of any adverse reactions. All doses applied in the present study led to significant clinical improvement over time and can therefore be regarded as effective doses. The influence of product doses in the range investigated seems to be low and can be neglected. Thus, the authorised dose range of 10-70 spheroids/cm 2  confirmed by this clinical trial offers a broad therapeutic window for the surgeon applying the product, thereby reducing the risk of over- or underdosing.
LEVEL OF EVIDENCE


I.",2020,"Likewise, assessment of the subjective IKDC score revealed no statistically significant differences between the three dose groups up to the 48-month visit.","['75 patients (22 women, 53 men) aged 34\u2009±\u20099\xa0years', 'Seventy-five patients']","['autologous chondrocyte implantation (ACI', 'matrix-associated autologous chondrocyte implantation with spheroid technology']","['mean MOCART total scores', 'efficacy and safety', ""mean 'overall KOOS' scores"", 'subjective IKDC score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}]","[{'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0540404', 'cui_str': 'adenylyl cyclase type I'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",75.0,0.0344594,"Likewise, assessment of the subjective IKDC score revealed no statistically significant differences between the three dose groups up to the 48-month visit.","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Freiburg University Hospital, Munich, Germany. phniemeyer@gmail.com.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Laute', 'Affiliation': 'Joint and Spine Centre Berlin, Berlin, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Zinser', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, St. Vinzenz-Hospital Dinslaken, Dinslaken, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'John', 'Affiliation': 'Clinic for Traumatology and Orthopedic Surgery, DRK Hospital Westend Berlin, Berlin, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Becher', 'Affiliation': 'Department of Orthopedic Surgery, Medical University Annastift Hanover, Hanover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Diehl', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, Orthopedic Center Munich East, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kolombe', 'Affiliation': 'Traumatology and Reconstructive Surgery, DRK Hospital Luckenwalde, Luckenwalde, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Fay', 'Affiliation': 'Department of Traumatology and Arthroscopic Surgery, Lubinus Clinicum Kiel, Kiel, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Siebold', 'Affiliation': 'Center for Hip, Knee and Foot Surgery, ATOS Clinic Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Fickert', 'Affiliation': 'Sporthopaedicum Straubing, Straubing, Germany.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05786-8']
214,32282432,Subcutaneous Nitroglycerin for Radial Arterial Catheterization in Pediatric Patients: A Randomized Controlled Trial.,"BACKGROUND


Pediatric radial artery cannulation is challenging because of the small vessel size. Nitroglycerin is a potent vasodilator and facilitates radial artery cannulation by increasing the internal diameter and preventing the vasospasm in adult patients. The authors hypothesize that subcutaneous nitroglycerin injection will improve the success rate of pediatric radial artery cannulation.
METHODS


This double-blind, randomized, controlled, single-center study enrolled pediatric patients (n = 113, age less than 2 yr) requiring radial artery cannulation during general anesthesia. The participants were randomized into the nitroglycerin group (n = 57) or control group (n = 56). After inducing general anesthesia, nitroglycerin solution (5 μg/kg in 0.5 ml), or normal saline (0.5 ml) was subcutaneously injected above the chosen radial artery over 10 s with ultrasound guidance. Three minutes later, the ultrasound-guided radial artery cannulation was performed. Radial artery diameter was measured before and after the subcutaneous injection and after cannulation. The primary outcome was the first-attempt successful cannulation rate. The secondary outcomes included the diameter of the radial artery and the overall complication rate including hematoma and vasospasm.
RESULTS


A total of 113 children were included in the analysis. The nitroglycerin group had a higher first-attempt success rate than the control group (91.2% [52 of 57] vs. 66.1% [37 of 56]; P = 0.002; odds ratio, 5.3; 95% CI, 1.83 to 15.6; absolute risk reduction, -25.2%; 95% CI, -39.6 to -10.7%). Subcutaneous nitroglycerin injection increased the diameter of the radial artery greater than normal saline (25.0 ± 19.5% vs. 1.9 ± 13.1%; 95% CI of mean difference, 16.9 to 29.3%; P < 0.001). Overall complication rate was lower in the nitroglycerin group than in the control group (3.5% [2 of 57] vs. 31.2% [18 of 56]; P = 0.001; odds ratio, 0.077; 95% CI, 0.017 to 0.350; absolute risk reduction, 28.6%; 95% CI, 15.5 to 41.8%).
CONCLUSIONS


Subcutaneous nitroglycerin injection before radial artery cannulation improved the first-attempt success rate and reduced the overall complication rates in pediatric patients.",2020,"The nitroglycerin group had a higher first-attempt success rate than the control group (91.2% [52 of 57] vs. 66.1% [37 of 56]; P = 0.002; odds ratio, 5.3; 95% CI, 1.83 to 15.6; absolute risk reduction, -25.2%; 95% CI, -39.6 to -10.7%).","['Pediatric Patients', 'enrolled pediatric patients (n = 113, age less than 2 yr) requiring radial artery cannulation during general anesthesia', '113 children', 'pediatric patients', 'adult patients']","['Subcutaneous Nitroglycerin', 'nitroglycerin', 'Subcutaneous nitroglycerin', 'normal saline', 'Nitroglycerin', 'nitroglycerin injection', 'nitroglycerin solution']","['success rate of arterial cannulation', 'Radial artery diameter', 'diameter of the radial artery and the overall complication rate including hematoma and vasospasm', 'diameter of the radial artery', 'first-attempt successful cannulation rate', 'higher first-attempt success rate', 'Overall complication rate', 'overall complication rates']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C4307250', 'cui_str': 'Nitroglycerin Injection'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0205250', 'cui_str': 'High'}]",113.0,0.634855,"The nitroglycerin group had a higher first-attempt success rate than the control group (91.2% [52 of 57] vs. 66.1% [37 of 56]; P = 0.002; odds ratio, 5.3; 95% CI, 1.83 to 15.6; absolute risk reduction, -25.2%; 95% CI, -39.6 to -10.7%).","[{'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': ""From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea (Y.-E.J., S.-H.J., E.-H.K., J.-H.L.) the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea (H.-S.K., J.-T.K.) the Division of Pediatric Cardiovascular Anesthesia, Baylor College of Medicine, Texas Children's Hospital, Houston, Texas (E.B.M.).""}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Emad B', 'Initials': 'EB', 'LastName': 'Mossad', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003308']
215,32283078,Is There a Difference in Volumetric Change and Effectiveness Comparing Pedicled Buccal Fat Pad and Abdominal Fat When Used as Interpositional Arthroplasty in the Treatment of Temporomandibular Joint Ankylosis?,"PURPOSE


There is limited evidence in the literature about fat grafting in the management of temporomandibular joint ankylosis (TMJA). The purpose was to investigate which interpositional fat grafting technique is superior in the operative management of TMJA. The specific aim was to compare the volumetric change and maximal mouth opening (MIO) when pedicled buccal fat or abdominal fat is interposed in patients being treated for TMJA.
PATIENTS AND METHODS


A randomized controlled trial was conducted on TMJA patients divided into 2 groups: Pedicled buccal fat pad was used for interposition in group A, whereas abdominal fat was used in group B. At the end of 1 year, the volumetric change in fat was analyzed by comparing immediate postoperative and 1-year follow-up magnetic resonance imaging (MRI). MIO and re-ankylosis were recorded. Categorical variables were analyzed by the χ 2  test or Fisher exact test. Continuous variables were compared using the t test and Wilcoxon signed rank test. Linear regression analysis was performed.
RESULTS


A total of 36 patients (51 joints [15 bilateral and 21 unilateral]) were included, comprising 18 in group A and 18 in group B. The mean preoperative MIO measured 6.8 mm in group A and 4.2 mm in group B. The mean immediate postoperative MRI fat volume was 4.3 cm 3  in group A and 10.8 cm 3  in group B. One-year follow-up MRI showed a fat retention rate of 32.44% in group A and 58.17% in group B. The rate of volumetric shrinkage was 67.5% in group A and 41.9% in group B (P < .001). Analysis of variance showed a statistically significant difference between volumetric shrinkage and both treatment groups (P < .001). MIO improved to 30.6 mm in the pedicled buccal fat pad group (group A) and 41.9 mm in the abdominal fat group (group B) (P < .001). No re-ankylosis occurred in either group at 1-year follow-up.
CONCLUSIONS


Our study results suggest that the percentage of retention of interposed abdominal fat at 1 year is more than that of pedicled buccal fat pad. Volumetric shrinkage is greater with buccal fat pad, which is a paradox considering the pedicled blood supply. Abdominal fat is better than pedicled buccal fat pad when used for interposition in TMJA treatment.",2020,The rate of volumetric shrinkage was 67.5% in group A and 41.9% in group B (P < .001).,"['36 patients (51 joints [15 bilateral and 21 unilateral', 'patients being treated for TMJA', 'TMJA patients divided into 2 groups']",['Pedicled buccal fat pad was used for interposition'],"['fat retention rate', 'mean preoperative MIO', 'Volumetric Change and Effectiveness Comparing Pedicled Buccal Fat Pad and Abdominal Fat', 'MIO', 'percentage of retention of interposed abdominal fat', 'mean immediate postoperative MRI fat volume', 're-ankylosis', 'volumetric shrinkage', 'volumetric change and maximal mouth opening (MIO', 'Volumetric shrinkage', 'MIO and re-ankylosis', 'volumetric change in fat', 'rate of volumetric shrinkage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2931375', 'cui_str': 'Ankylosis of temporomandibular joint'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0226900', 'cui_str': 'Buccal fat pad'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0226900', 'cui_str': 'Buccal fat pad'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0003090', 'cui_str': 'Ankylosis'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",36.0,0.055982,The rate of volumetric shrinkage was 67.5% in group A and 41.9% in group B (P < .001).,"[{'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Roychoudhury', 'Affiliation': 'Professor and Head, Department of Oral & Maxillofacial Surgery, All India Institute of Medical Sciences, New Delhi, India. Electronic address: ajoyroy@hotmail.com.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'Ex-Junior Resident, Department of Oral & Maxillofacial surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ongkila', 'Initials': 'O', 'LastName': 'Bhutia', 'Affiliation': 'Professor, Department of Oral & Maxillofacial Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Seith Bhalla', 'Affiliation': 'Professor, Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Manchanda', 'Affiliation': 'Associate Professor, Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Professor and Head, Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.03.006']
216,31702883,A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus.,"BACKGROUND


Difelikefalin is a peripherally restricted and selective agonist of kappa opioid receptors that are considered to be important in modulating pruritus in conditions such as chronic kidney disease.
METHODS


In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks. The primary outcome was the percentage of patients with an improvement (decrease) of at least 3 points from baseline at week 12 in the weekly mean score on the 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS; scores range from 0 to 10, with higher scores indicating greater itch intensity). The secondary outcomes included the change from baseline in itch-related quality-of-life measures, the percentage of patients with an improvement of at least 4 points in the WI-NRS score at week 12, and safety.
RESULTS


A total of 378 patients underwent randomization. A total of 82 of 158 patients (51.9%) in the difelikefalin group had a decrease of at least 3 points in the WI-NRS score (primary outcome), as compared with 51 of 165 (30.9%) in the placebo group. The imputed percentage of patients with a decrease of at least 3 points in the WI-NRS score was 49.1% in the difelikefalin group, as compared with 27.9% in the placebo group (P<0.001). Difelikefalin also resulted in a significant improvement from baseline to week 12 in itch-related quality of life as measured by the 5-D itch scale and the Skindex-10 scale. The imputed percentage of patients with a decrease of at least 4 points in the WI-NRS score at week 12 was significantly greater in the difelikefalin group than in the placebo group (37.1% [observed data: 64 of 158 patients] vs. 17.9% [observed data: 35 of 165 patients], P<0.001). Diarrhea, dizziness, and vomiting were more common in the difelikefalin group than in the placebo group.
CONCLUSIONS


Patients treated with difelikefalin had a significant reduction in itch intensity and improved itch-related quality of life as compared with those who received placebo. (Funded by Cara Therapeutics; KALM-1 ClinicalTrials.gov number, NCT03422653.).",2020,"Diarrhea, dizziness, and vomiting were more common in the difelikefalin group than in the placebo group.
","['Hemodialysis Patients with Pruritus', 'patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either', '378 patients underwent randomization']","['placebo', 'intravenous difelikefalin', 'Difelikefalin', 'difelikefalin']","['Diarrhea, dizziness, and vomiting', 'itch-related quality of life', 'WI-NRS score', '24-hour Worst Itching Intensity Numerical Rating Scale', 'itch intensity and improved itch-related quality of life', 'change from baseline in itch-related quality-of-life measures, the percentage of patients with an improvement of at least 4 points in the WI-NRS score at week 12, and safety']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0222045'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",378.0,0.341431,"Diarrhea, dizziness, and vomiting were more common in the difelikefalin group than in the placebo group.
","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'From the Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (S.F.); North America Research Institute, San Dimas, CA (A.J.); and Cara Therapeutics, Stamford, CT (C.M., W.W., F.M.).'}, {'ForeName': 'Aamir', 'Initials': 'A', 'LastName': 'Jamal', 'Affiliation': 'From the Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (S.F.); North America Research Institute, San Dimas, CA (A.J.); and Cara Therapeutics, Stamford, CT (C.M., W.W., F.M.).'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Munera', 'Affiliation': 'From the Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (S.F.); North America Research Institute, San Dimas, CA (A.J.); and Cara Therapeutics, Stamford, CT (C.M., W.W., F.M.).'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Wen', 'Affiliation': 'From the Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (S.F.); North America Research Institute, San Dimas, CA (A.J.); and Cara Therapeutics, Stamford, CT (C.M., W.W., F.M.).'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Menzaghi', 'Affiliation': 'From the Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, Great Neck, NY (S.F.); North America Research Institute, San Dimas, CA (A.J.); and Cara Therapeutics, Stamford, CT (C.M., W.W., F.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1912770']
217,32078683,Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial.,"Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT03340493.",2020,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","['Adult patients (N\u2009=\u2009300) with ischemic stroke due to occlusion of the intracranial internal carotid, \\basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria', 'All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial', 'Patients With Large Vessel Occlusion Ischemic Stroke', 'Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019', '27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes', 'patients with large vessel occlusion ischemic stroke']","['Interventions\n\n\nOpen-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n\u2009=\u2009150) or 0.25 mg/kg']","['Cerebral Reperfusion', 'occluded vascular territory', 'cause deaths', 'symptomatic intracranial hemorrhage', 'cerebral reperfusion', '4 functional outcomes', 'reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy', 'level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",,0.594367,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","[{'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Yassi', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Dowling', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Bush', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scroop', 'Affiliation': 'Department of Radiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Simpson', 'Affiliation': 'Department of Neurology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brooks', 'Affiliation': 'Department of Radiology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Asadi', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Teddy Y', 'Initials': 'TY', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Darshan G', 'Initials': 'DG', 'LastName': 'Shah', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tissa', 'Initials': 'T', 'LastName': 'Wijeratne', 'Affiliation': 'Melbourne Medical School, Department of Medicine and Neurology, The University of Melbourne and Western Health, Sunshine Hospital, St Albans Victoria, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Fana', 'Initials': 'F', 'LastName': 'Alemseged', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bailey', 'Affiliation': 'Department of Neurology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rice', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'de Villiers', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Dewey', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Philip M C', 'Initials': 'PMC', 'LastName': 'Choi', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kendal', 'Initials': 'K', 'LastName': 'Redmond', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leggett', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Fink', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Collecutt', 'Affiliation': 'Department of Radiology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Medicine, Ballarat Base Hospital, Ballarat, Victoria, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Department of Neurology, Royal North Shore Hospital and Kolling Institute, University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Cordato', 'Affiliation': 'Department of Neurology, Liverpool Hospital, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Field', 'Affiliation': 'Department of Neurology, Lyell McEwin Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'School of Clinical Sciences, Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neurology, Gosford Hospital, Gosford, New South Wales, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Clissold', 'Affiliation': 'Department of Neurology, University Hospital Geelong, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Miteff', 'Affiliation': 'Department of Neurology, Priority Research Centre for Brain and Mental Health Research, John Hunter Hospital, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Clissold', 'Affiliation': 'Department of Medicine, Southwest Healthcare, Warrnambool, Victoria, Australia.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Cloud', 'Affiliation': 'Department of Neurology, Alfred Hospital, Prahran, Victoria, Australia.'}, {'ForeName': 'Leslie E', 'Initials': 'LE', 'LastName': 'Bolitho', 'Affiliation': 'Department of Medicine, Northeast Health, Wangaratta, Victoria, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bonavia', 'Affiliation': 'Department of Medicine, Albury Base Hospital, Albury, New South Wales, Australia.'}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Medicine, Goulburn Valley Health, Shepparton, Victoria, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine, Latrobe Regional Health, Traralgon, Victoria, Australia.'}, {'ForeName': 'Abul', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Department of Medicine, Campbelltown Hospital, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Fintan', 'Initials': 'F', 'LastName': ""O'Rourke"", 'Affiliation': 'Department of Aged Care and Rehabilitation, Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Department of Neurology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wong', 'Affiliation': ""Department of Neurology, Royal Brisbane and Women's Hospital and the University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Maridulu budyari gumal, The Sydney Partnership for Health Education Research & Enterprise (SPHERE), University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Bladin', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Desmond', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.1511']
218,32279619,Clinical and Imaging Determinants of Collateral Status in Patients With Acute Ischemic Stroke in MR CLEAN Trial and Registry.,"Background and Purpose- Collateral circulation status at baseline is associated with functional outcome after ischemic stroke and effect of endovascular treatment. We aimed to identify clinical and imaging determinants that are associated with collateral grade on baseline computed tomography angiography in patients with acute ischemic stroke due to an anterior circulation large vessel occlusion. Methods- Patients included in the MR CLEAN trial (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands; n=500) and MR CLEAN Registry (n=1488) were studied. Collateral status on baseline computed tomography angiography was scored from 0 (absent) to 3 (good). Multivariable ordinal logistic regression analyses were used to test the association of selected determinants with collateral status. Results- In total, 1988 patients were analyzed. Distribution of the collateral status was as follows: absent (7%, n=123), poor (32%, n=596), moderate (39%, n=735), and good (23%, n=422). Associations for a poor collateral status in a multivariable model existed for age (adjusted common odds ratio, 0.92 per 10 years [95% CI, 0.886-0.98]), male (adjusted common odds ratio, 0.64 [95% CI, 0.53-0.76]), blood glucose level (adjusted common odds ratio, 0.97 [95% CI, 0.95-1.00]), and occlusion of the intracranial segment of the internal carotid artery with occlusion of the terminus (adjusted common odds ratio 0.50 [95% CI, 0.41-0.61]). In contrast to previous studies, we did not find an association between cardiovascular risk factors and collateral status. Conclusions- Older age, male sex, high glucose levels, and intracranial internal carotid artery with occlusion of the terminus occlusions are associated with poor computed tomography angiography collateral grades in patients with acute ischemic stroke eligible for endovascular treatment.",2020,"Associations for a poor collateral status in a multivariable model existed for age (adjusted common odds ratio, 0.92 per 10 years [95% CI, 0.886-0.98]), male (adjusted common odds ratio, 0.64 [95% CI, 0.53-0.76]), blood glucose level (adjusted common odds ratio, 0.97 [95% CI, 0.95-1.00]), and occlusion of the intracranial segment of the internal carotid artery with occlusion of the terminus (adjusted common odds ratio 0.50 [95% CI, 0.41-0.61]).","['patients with acute ischemic stroke eligible for endovascular treatment', 'patients with acute ischemic stroke due to an anterior circulation large vessel occlusion', 'Patients With Acute Ischemic Stroke in MR CLEAN Trial and Registry', '1988 patients were analyzed']","[' and Purpose', 'Endovascular Treatment']","['blood glucose level', 'Collateral circulation status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0009348', 'cui_str': 'Collateral circulation'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",1988.0,0.0982939,"Associations for a poor collateral status in a multivariable model existed for age (adjusted common odds ratio, 0.92 per 10 years [95% CI, 0.886-0.98]), male (adjusted common odds ratio, 0.64 [95% CI, 0.53-0.76]), blood glucose level (adjusted common odds ratio, 0.97 [95% CI, 0.95-1.00]), and occlusion of the intracranial segment of the internal carotid artery with occlusion of the terminus (adjusted common odds ratio 0.50 [95% CI, 0.41-0.61]).","[{'ForeName': 'Eveline J A', 'Initials': 'EJA', 'LastName': 'Wiegers', 'Affiliation': 'From the Department of Public Health (E.J.A.W., E.V., H.F.L.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Maxim J H L', 'Initials': 'MJHL', 'LastName': 'Mulder', 'Affiliation': 'Department of Neurology (M.J.H.L.M., E.V., K.C.J.C., O.A.B., B.R., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Ivo G H', 'Initials': 'IGH', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Nuclear Medicine (I.G.H.J., B.J.E., H.A.M., M.E.S., C.B.L.M.M.), Amsterdam UMC, location AMC, the Netherlands.'}, {'ForeName': 'Esmee', 'Initials': 'E', 'LastName': 'Venema', 'Affiliation': 'From the Department of Public Health (E.J.A.W., E.V., H.F.L.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Kars C J', 'Initials': 'KCJ', 'LastName': 'Compagne', 'Affiliation': 'Department of Neurology (M.J.H.L.M., E.V., K.C.J.C., O.A.B., B.R., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Olvert A', 'Initials': 'OA', 'LastName': 'Berkhemer', 'Affiliation': 'Department of Neurology (M.J.H.L.M., E.V., K.C.J.C., O.A.B., B.R., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology and Nuclear Medicine (I.G.H.J., B.J.E., H.A.M., M.E.S., C.B.L.M.M.), Amsterdam UMC, location AMC, the Netherlands.'}, {'ForeName': 'Henk A', 'Initials': 'HA', 'LastName': 'Marquering', 'Affiliation': 'Department of Radiology and Nuclear Medicine (I.G.H.J., B.J.E., H.A.M., M.E.S., C.B.L.M.M.), Amsterdam UMC, location AMC, the Netherlands.'}, {'ForeName': 'Adriaan C G M', 'Initials': 'ACGM', 'LastName': 'van Es', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.J.H.L.M., K.C.J.C., O.A.B., A.C.G.M.v.E., B.R., A.v.d.L.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Marieke E', 'Initials': 'ME', 'LastName': 'Sprengers', 'Affiliation': 'Department of Radiology and Nuclear Medicine (I.G.H.J., B.J.E., H.A.M., M.E.S., C.B.L.M.M.), Amsterdam UMC, location AMC, the Netherlands.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'Cardiovascular Research Institute Maastricht, the Netherlands (O.A.B., W.H.v.Z., R.J.v.O.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'Cardiovascular Research Institute Maastricht, the Netherlands (O.A.B., W.H.v.Z., R.J.v.O.).'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'Department of Neurology, Academic Medical Center, Amsterdam, the Netherlands (Y.B.W.E.M.R.).'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine (I.G.H.J., B.J.E., H.A.M., M.E.S., C.B.L.M.M.), Amsterdam UMC, location AMC, the Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'Department of Neurology (M.J.H.L.M., E.V., K.C.J.C., O.A.B., B.R., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'From the Department of Public Health (E.J.A.W., E.V., H.F.L.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'Department of Neurology (M.J.H.L.M., E.V., K.C.J.C., O.A.B., B.R., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.J.H.L.M., K.C.J.C., O.A.B., A.C.G.M.v.E., B.R., A.v.d.L.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.027483']
219,32276987,First-line oxygen therapy with high-flow in bronchiolitis is not cost saving for the health service.,"BACKGROUND


Bronchiolitis is the most common reason for hospital admission in infants. High-flow oxygen therapy has emerged as a new treatment; however, the cost-effectiveness of using it as first-line therapy is unknown.
OBJECTIVE


To compare the cost of providing high-flow therapy as a first-line therapy compared with rescue therapy after failure of standard oxygen in the management of bronchiolitis.
METHODS


A within-trial economic evaluation from the health service perspective using data from a multicentre randomised controlled trial for hypoxic infants (≤12 months) admitted to hospital with bronchiolitis in Australia and New Zealand. Intervention costs, length of hospital and intensive care stay and associated costs were compared for infants who received first-line treatment with high-flow therapy (early high-flow, n=739) or for infants who received standard oxygen and optional rescue high-flow (rescue high-flow, n=733). Costs were applied using Australian costing sources and are reported in 2016-2017 AU$.
RESULTS


The incremental cost to avoid one treatment failure was AU$1778 (95% credible interval (CrI) 207 to 7096). Mean cost of bronchiolitis treatment including intervention costs and costs associated with length of stay was AU$420 (95% CrI -176 to 1002) higher per infant in the early high-flow group compared with the rescue high-flow group. There was an 8% (95% CrI 7.5 to 8.6) likelihood of the early high-flow oxygen therapy being cost saving.
CONCLUSIONS


The use of high-flow oxygen as initial therapy for respiratory failure in infants with bronchiolitis is unlikely to be cost saving to the health system, compared with standard oxygen therapy with rescue high-flow.",2020,"Intervention costs, length of hospital and intensive care stay and associated costs were compared for infants who received first-line treatment with high-flow therapy (early high-flow, n=739) or for infants who received standard oxygen and optional rescue high-flow (rescue high-flow, n=733).","['hospital admission in infants', 'hypoxic infants (≤12 months) admitted to hospital with bronchiolitis in Australia and New Zealand', 'infants with bronchiolitis']","['High-flow oxygen therapy', 'standard oxygen and optional rescue high-flow']","['Mean cost of bronchiolitis treatment including intervention costs and costs associated with length of stay', 'Intervention costs, length of hospital and intensive care stay and associated costs']","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.0885389,"Intervention costs, length of hospital and intensive care stay and associated costs were compared for infants who received first-line treatment with high-flow therapy (early high-flow, n=739) or for infants who received standard oxygen and optional rescue high-flow (rescue high-flow, n=733).","[{'ForeName': 'Vijay S', 'Initials': 'VS', 'LastName': 'Gc', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Franklin', 'Affiliation': 'Paediatric Critical Care Research Group, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Whitty', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Dalziel', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Luregn J', 'Initials': 'LJ', 'LastName': 'Schlapbach', 'Affiliation': 'Paediatric Critical Care Research Group, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Fraser', 'Affiliation': 'The University of Queensland Child Health Research Centre, School of Medicine, Brisbane, Queensland, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Neutze', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Oakley', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schibler', 'Affiliation': 'Paediatric Critical Care Research Group, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia a.schibler@uq.edu.au.'}]",Archives of disease in childhood,['10.1136/archdischild-2019-318427']
220,31590108,Randomized controlled trial of cryotherapy to prevent paclitaxel-induced peripheral neuropathy (RU221511I); an ACCRU trial.,"PURPOSE


This pilot trial aimed to assess if cooling hands and feet with crushed ice during receipt of paclitaxel helps prevent peripheral neuropathy.
METHODS


This prospective, randomized trial compared cryotherapy to standard care in patients initiating paclitaxel weekly x 12. For those on cryotherapy, hands and feet were cooled starting 15 min prior to and ending 15 min after each paclitaxel dose. EORTC QLQ-CIPN20 was completed at baseline, weekly x12, then monthly x6. Area under the curve (AUC) was calculated for subscale scores, adjusting for baseline, and compared between arms (Wilcoxon rank-sum test). Cross-study comparisons used data from 2 prior similarly-conducted neuropathy trials.
RESULTS


Forty-six patients were accrued. Three withdrew and one was ineligible. Of the remaining 42 (21 cryotherapy, 21 control), 39 (19 cryotherapy, 20 control) were analyzable for AUC. Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26). However, the control arm of the current trial experienced less neuropathy than did the placebo arms of two previous similar trials. When our cryotherapy arm was compared to the combined control arms from all three trials, the cryotherapy arm had less neuropathy (Wilcoxon Rank-Sum p = 0.01).
CONCLUSION


While there was no difference in CIPN20 scores identified between the 2 study arms in the current phase II trial, further investigation is needed given that the control arm experienced less neuropathy than was expected.",2019,"Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26).","['patients initiating paclitaxel weekly x 12', 'Forty-six patients were accrued']","['Cryotherapy', 'placebo', 'cryotherapy', 'paclitaxel']","['CIPN20 scores', 'Area under the curve (AUC', 'CIPN20 sensory scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}]",46.0,0.0622765,"Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26).","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Electronic address: Ruddy.kathryn@mayo.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Le-Rademacher', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Mario E', 'Initials': 'ME', 'LastName': 'Lacouture', 'Affiliation': 'Department of Dermatology, Memorial Sloan Kettering Cancer Center, 1275 York Ave., New York, NY, 10065, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Wilkinson', 'Affiliation': 'Inova Hematology Oncology, 8501 Arlington Blvd., Suite 340, Fairfax, VA, 22031, USA.'}, {'ForeName': 'Adedayo A', 'Initials': 'AA', 'LastName': 'Onitilo', 'Affiliation': 'Marshfield Clinic - Weston Center, 3501 Cranberry Blvd., Weston, WI, 54476, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Vander Woude', 'Affiliation': 'Cancer and Hematology Centers of Western Michigan, 145 Michigan St. NE, #3100, Grand Rapids, MI, 49503, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Grosse-Perdekamp', 'Affiliation': 'Carle Cancer Center, 509 W. University Ave., Urbana, IL, 61801, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Dockter', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Angelina D', 'Initials': 'AD', 'LastName': 'Tan', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Beutler', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2019.09.011']
221,31591483,Role of appetitive phenotype trajectory groups on child body weight during a family-based treatment for children with overweight or obesity.,"OBJECTIVE


Emerging evidence suggests that individual appetitive traits may usefully explain patterns of weight loss in behavioral weight loss treatments for children. The objective of this study was to identify trajectories of child appetitive traits and the impact on child weight changes over time.
METHODS


Secondary data analyses of a randomized noninferiority trial conducted between 2011 and 2015 evaluated children's appetitive traits and weight loss. Children with overweight and obesity (mean age = 10.4; mean BMI z = 2.0; 67% girls; 32% Hispanic) and their parent (mean age = 42.9; mean BMI = 31.9; 87% women; 31% Hispanic) participated in weight loss programs and completed assessments at baseline, 3, 6,12, and 24 months. Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories. Linear mixed-effects models were used to identify the impact of group trajectory on child BMIz change over time.
RESULTS


One hundred fifty children and their parent enrolled in the study. The three-group trajectory model was the most parsimonious and included a high satiety responsive group (HighSR; 47.4%), a high food responsive group (HighFR; 34.6%), and a high emotional eating group (HighEE; 18.0%). Children in all trajectories lost weight at approximately the same rate during treatment, however, only the HighSR group maintained their weight loss during follow-ups, while the HighFR and HighEE groups regained weight (adjusted p-value < 0.05).
CONCLUSIONS


Distinct trajectories of child appetitive traits were associated with differential weight loss maintenance. Identified high-risk subgroups may suggest opportunities for targeted intervention and maintenance programs.",2019,"Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories.","['children', 'children with overweight or obesity', 'Children with overweight and obesity (mean age\u2009', 'One hundred fifty children and their parent enrolled in the study', ""2011 and 2015 evaluated children's appetitive traits and weight loss""]",['appetitive phenotype trajectory'],"['child body weight', 'differential weight loss maintenance', 'child BMIz change over time', 'weight loss', 'child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",150.0,0.0200187,"Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories.","[{'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA. kboutelle@ucsd.edu.'}, {'ForeName': 'D Eastern', 'Initials': 'DE', 'LastName': 'Kang Sim', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manzano', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Kyung E', 'Initials': 'KE', 'LastName': 'Rhee', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, La Jolla, CA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0463-4']
222,32191071,Setting a goal could help you control: Comparing the effect of health goal versus general episodic future thinking on health behaviors among cigarette smokers and obese individuals.,"Episodic Future Thinking (EFT) reduces delay discounting (DD; preference for smaller, immediate rewards) and various maladaptive behaviors. Exploring potential personalization of EFT to optimize its ability to alter DD and demand for unhealthy reinforcers is important for the development of interventions targeting long-term improvement and maintenance of health. In this investigation, using 2 separate studies, we examined the effects of EFT with and without a health goal on rates of discounting, demand, and craving for cigarettes and fast food among cigarette smokers and obese individuals, respectively. Using data collected from Amazon Mechanical Turk (mTurk), Study 1 ( N  = 189) examined the effect of EFT on DD and measures of cigarette demand and craving in cigarette smokers who were randomly assigned to 1 of 3 conditions: EFT-health goal, EFT-general, or Episodic Recent Thinking (ERT)-general. Study 2 ( N  = 255), using a 2x2 factorial design, examined the effects of health goals and general EFT on DD and measures of fast food demand and craving in obese individuals who were randomly assigned to 1 of 4 conditions: EFT-health goal, EFT-general, ERT-health goal or ERT-general. Health goal EFT was not more effective than general EFT in reducing monetary discounting. However, the addition of a health goal to general EFT was significantly associated with higher effect on intensity and elasticity of demand for cigarettes and fast food compared to EFT without a health goal. These findings suggest that the amplification of future thinking through the inclusion of a health goal may promote healthy decisions and result in positive behavior changes. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,Health goal EFT was not more effective than general EFT in reducing monetary discounting.,"['obese individuals who were randomly assigned to 1 of 4 conditions: EFT-health goal, EFT-general, ERT-health goal or ERT-general', 'cigarette smokers who were randomly assigned to 1 of 3 conditions: EFT-health goal, EFT-general, or Episodic Recent Thinking (ERT)-general', 'cigarette smokers and obese individuals']","['EFT', 'Episodic Future Thinking (EFT', 'health goals and general EFT', 'health goal versus general episodic future thinking']","['intensity and elasticity of demand for cigarettes and fast food', 'rates of discounting, demand, and craving for cigarettes and fast food', 'health behaviors']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0013764'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0018687'}]",,0.0442723,Health goal EFT was not more effective than general EFT in reducing monetary discounting.,"[{'ForeName': 'Liqa N', 'Initials': 'LN', 'LastName': 'Athamneh', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Madison D', 'Initials': 'MD', 'LastName': 'Stein', 'Affiliation': 'Center for Transformative Research on Health Behaviors.'}, {'ForeName': 'Elysia H', 'Initials': 'EH', 'LastName': 'Lin', 'Affiliation': 'Center for Transformative Research on Health Behaviors.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Stein', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Mellis', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Kirstin M', 'Initials': 'KM', 'LastName': 'Gatchalian', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Addiction Recovery Research Center.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000351']
223,31655812,Design and Baseline Characteristics of the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease Trial.,"BACKGROUND


Among diabetics, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality, and progression of their underlying disease. Finerenone is a novel, non-steroidal, selective mineralocorticoid-receptor antagonist which has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD), while revealing only a low risk of hyperkalemia. However, the effect of finerenone on renal and CV outcomes has not been investigated in long-term trials yet.
METHODS


The Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease -(FIDELIO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important renal and CV outcomes in T2D patients with CKD. FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 5.5 years. FIDELIO-DKD randomized 5,734 patients with an estimated glomerular filtration rate (eGFR) ≥25-<75 mL/min/1.73 m2 and albuminuria (urinary albumin-to-creatinine ratio ≥30-≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death.
CONCLUSION


FIDELIO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of renal and CV events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen.",2019,"The study has at least 90% power to detect a 20% reduction in the risk of primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death.
","['T2D patients with CKD at high risk of renal and CV events', '47 countries with an expected duration of approximately 5.5 years', 'type 2 diabetes (T2D) patients with chronic kidney disease (CKD', '≥30-≤5,000', 'T2D patients with CKD', '5,734 patients with an estimated\xa0glomerular filtration rate (eGFR) ≥25-<75 mL']","['placebo', 'Finerenone', 'finerenone']","['composite of time to first occurrence of kidney failure', 'Kidney Failure and Disease Progression', 'renal death', 'renal and CV outcomes', 'albuminuria (urinary albumin-to-creatinine ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3811844'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4045511', 'cui_str': 'finerenone'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",5734.0,0.457001,"The study has at least 90% power to detect a 20% reduction in the risk of primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death.
","[{'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago Medicine, Chicago, Illinois, USA, gbakris@gmail.com.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Ruilope', 'Affiliation': 'Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Hospital Universitario 12 de Octubre, Madrid, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Nowack', 'Affiliation': 'Research and Development, Clinical Development Operations, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kolkhof', 'Affiliation': 'Research and Development, Preclinical Research Cardiovascular, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Ferreira', 'Affiliation': 'Research and Development, Clinical Operations, Bayer SA, São Paulo, Brazil.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schloemer', 'Affiliation': 'Research and Development, Statistics and Data Insights, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'Department of Cardiology, Attikon University Hospital, Athens, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000503713']
224,31987677,[Virtual simulation for learning cataract surgery].,"INTRODUCTION


The training in phacoemulsification cataract surgery in our context requires a long learning curve for a novice surgeon starting from the observation period to the realization of the different operating stages being supervised by a senior surgeon, all under stressful conditions. Topical or locoregional anesthesia limits the communication in the operating room between the novice surgeon and his mentor; thus, increasing the risk of having more operative complications. To reduce the teaching time of cataract surgery, our department has introduced virtual simulator trainings for phacoemulsification.
PURPOSE OF THE STUDY


To assess the impact of surgical simulator training on residents' performances.
MATERIAL AND METHODS


We conducted a prospective comparative study in our department in partnership with a private ophthalmology clinic where the simulator is installed. Twelve residents were included in this study, six of them were randomly selected to participate in the phacoemulsification surgical simulator training while the others never used the simulator. The training lasted 30 hours in total. No residents had previous training in phacoemulsification. The parameters studied were: the operating time, the achievement of a circular capsulorhexis of 5-6mm in diameter and well centered, the number of capsular breaks with or without an anterior vitrectomy and finally the accumulated dissipated energy (EDC). The cataract surgery was performed on an Alcon Centurion platform.
RESULTS


In the operating room, each resident operated 25 cataracts; we compared the two user groups including the simulator and non simulator user and we noticed a statistically significant difference (P<0.05) in terms of average operating time respectively 20 minutes and 37 minutes. Regarding the realization of capsulorhexis; 22 cases of rhexis wandering and 12 poorly centred rhexis on 150 operated cataracts were identified (22.7%) in the group of residents who received no simulator training versus 10 cases in the simulator user group (6.7%). The cumulative dissipated energy (EDC) was significantly lower in the simulator user group (8.1 versus 18.7). The same is true for the rate of posterior capsular rupture, which is higher in the non-user group of simulator 37 cases (24.6%) versus 10 cases (8%) in the second group.
DISCUSSION


Ophthalmic surgery has benefited from the introduction of endo-ocular surgical simulation tools through simulators of vitreoretinal surgery and phacoemulsification; whose main role is primarily pedagogical because a simulator allows young residents to acquire dexterity and autonomy over a shortened period of time in addition to minimizing the risk of complications.
CONCLUSION


Initial learning of phacoemulsification cataract surgery should be an integral part of the virtual simulator program before moving to the real conditions of the operating room as it allows for better operative performance with a minimal complication rate.",2020,The cumulative dissipated energy (EDC) was significantly lower in the simulator user group (8.1 versus 18.7).,"['our department in partnership with a private ophthalmology clinic', 'Twelve residents were included in this study, six of them were randomly selected to participate in the', ""residents' performances""]","['no simulator training', 'surgical simulator training', 'phacoemulsification surgical simulator training', 'phacoemulsification cataract surgery']","['cumulative dissipated energy (EDC', 'operating time, the achievement of a circular capsulorhexis of 5-6mm in diameter and well centered, the number of capsular breaks with or without an anterior vitrectomy and finally the accumulated dissipated energy (EDC']","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3838844', 'cui_str': 'Ophthalmology clinic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1282913', 'cui_str': 'Circular (qualifier value)'}, {'cui': 'C0525027', 'cui_str': 'Capsulorhexis'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0197786', 'cui_str': 'Anterior vitrectomy (procedure)'}]",12.0,0.018619,The cumulative dissipated energy (EDC) was significantly lower in the simulator user group (8.1 versus 18.7).,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Adnane', 'Affiliation': ""Service d'ophtalmologie adulte, hôpital du 20-Août-1953, faculté de médecine et de pharmacie, université Hassan II, CHU Ibn Rochd, Casablanca, Maroc.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chahbi', 'Affiliation': ""Clinique de l'œil de Casablanca, Maroc.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Elbelhadji', 'Affiliation': ""Service d'ophtalmologie adulte, hôpital du 20-Août-1953, faculté de médecine et de pharmacie, université Hassan II, CHU Ibn Rochd, Casablanca, Maroc.""}]",Journal francais d'ophtalmologie,['10.1016/j.jfo.2019.08.006']
225,30727012,Pericardial fluids or Cardiopulmonary Bypass-Is There a Major Culprit for Changes in Coagulation and Inflammation?,"BACKGROUND


From the results of a previous study, it remained to be investigated if a perioperative rise of few tested coagulation and inflammation markers is caused by conventional cardiopulmonary bypass (CPB) itself or rather by direct recirculation of pericardial fluids.
METHODS


Forty-eight patients operated on with conventional CPB for myocardial revascularization were randomized either for direct recirculation of pericardial suction fluids or for cell saving (CS).
RESULTS


Thrombin-antithrombin complexes showed lower values intraoperatively in the CS group ( p  < 0.0001), and D-dimers tended to remain lower at intensive care unit arrival ( p  = 0.095). Tests of inflammation markers were less meaningful.
CONCLUSION


Direct recirculation of pericardial fluids rather than conventional CPB itself causes major intraoperative changes of some coagulation markers. Pericardial blood loss with direct recirculation should be kept to a minimum to avoid unnecessary activation of coagulation. Inflammation markers need further investigations.",2020,"RESULTS


Thrombin-antithrombin complexes showed lower values intraoperatively in the CS group ( p  < 0.0001), and D-dimers tended to remain lower at intensive care unit arrival ( p  = 0.095).",['Forty-eight patients operated on with conventional CPB for myocardial revascularization'],"['Pericardial fluids or Cardiopulmonary Bypass', 'direct recirculation of pericardial suction fluids or for cell saving (CS', 'conventional CPB']",[],"[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0027056', 'cui_str': 'Myocardial Revascularization'}]","[{'cui': 'C0225973', 'cui_str': 'Pericardium Fluid'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0442031', 'cui_str': 'Pericardial (qualifier value)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]",[],48.0,0.028727,"RESULTS


Thrombin-antithrombin complexes showed lower values intraoperatively in the CS group ( p  < 0.0001), and D-dimers tended to remain lower at intensive care unit arrival ( p  = 0.095).","[{'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Gorki', 'Affiliation': 'Herz-, Thorax- und Gefäßchirurgie, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Herz-, Thorax- und Gefäßchirurgie, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kunert', 'Affiliation': 'Herz-, Thorax- und Gefäßchirurgie, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hoenicka', 'Affiliation': 'Herz-, Thorax- und Gefäßchirurgie, Universitätsklinik Ulm, Ulm, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Liebold', 'Affiliation': 'Herz-, Thorax- und Gefäßchirurgie, Universitätsklinik Ulm, Ulm, Germany.'}]",The Thoracic and cardiovascular surgeon,['10.1055/s-0039-1677836']
226,31278280,"Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults.","Nicotinamide riboside (NR) is a newly discovered nicotinamide adenine dinucleotide (NAD + ) precursor vitamin. A crystal form of NR chloride termed NIAGEN is generally recognized as safe (GRAS) for use in foods and the subject of two New Dietary Ingredient Notifications for use in dietary supplements. To evaluate the kinetics and dose-dependency of NR oral availability and safety in overweight, but otherwise healthy men and women, an 8-week randomized, double-blind, placebo-controlled clinical trial was conducted. Consumption of 100, 300 and 1000 mg NR dose-dependently and significantly increased whole blood NAD +  (i.e., 22%, 51% and 142%) and other NAD +  metabolites within 2 weeks. The increases were maintained throughout the remainder of the study. There were no reports of flushing and no significant differences in adverse events between the NR and placebo-treated groups or between groups at different NR doses. NR also did not elevate low density lipoprotein cholesterol or dysregulate 1-carbon metabolism. Together these data support the development of a tolerable upper intake limit for NR based on human data.",2019,There were no reports of flushing and no significant differences in adverse events between the NR and placebo-treated groups or between groups at different NR doses.,"['overweight, but otherwise healthy men and women', 'Healthy Overweight Adults']","['Placebo', 'NIAGEN (Nicotinamide Riboside Chloride', 'Nicotinamide riboside (NR', 'placebo']","['whole blood NAD ', 'low density lipoprotein cholesterol or dysregulate 1-carbon metabolism', 'adverse events']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068711', 'cui_str': 'pyridinium, 3-(aminocarbonyl)-1-beta-D-ribofuranosyl-'}, {'cui': 'C0008203', 'cui_str': 'Chlorides'}]","[{'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0621630', 'cui_str': 'NAD(S)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.38731,There were no reports of flushing and no significant differences in adverse events between the NR and placebo-treated groups or between groups at different NR doses.,"[{'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Conze', 'Affiliation': 'Chromadex Spherix Consulting, 11821 Parklawn Drive, Suite 310, Rockville, MD, 20852, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Brenner', 'Affiliation': 'Department of Biochemistry, University of Iowa, 4-403 BSB, Iowa City, IA, 52242, United States. charles-brenner@uiowa.edu.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Kruger', 'Affiliation': 'Chromadex Spherix Consulting, 11821 Parklawn Drive, Suite 310, Rockville, MD, 20852, United States. clairek@chromadex.com.'}]",Scientific reports,['10.1038/s41598-019-46120-z']
227,31665733,Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial.,"BACKGROUND


Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials.
PATIENTS AND METHODS


The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate ≥25 mL/min/1.73 m2 and albuminuria (urinary albumin-to-creatinine ratio ≥30 to ≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.
CONCLUSIONS


FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen.
TRIAL REGISTRATION


EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049.",2019,"FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate ≥25 mL","['people with diabetes', 'Diabetic Kidney Disease Trial', '7,437 patients with an estimated glomerular filtration rate ≥25 mL', 'type 2 diabetes (T2D) patients with chronic kidney disease (CKD', 'T2D patients with CKD', '47 countries with an expected duration of approximately 6 years', 'T2D patients with CKD at high risk of CV and renal events', 'Diabetic Kidney Disease']","['placebo', 'Finerenone', 'finerenone']","['composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure', 'efficacy and safety', 'Cardiovascular Mortality and Morbidity', 'CV Mortality and Morbidity']","[{'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3811844'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4045511', 'cui_str': 'finerenone'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.553545,"FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate ≥25 mL","[{'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Ruilope', 'Affiliation': 'Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain, ruilope@icloud.com.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiologsupply, and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'Department of Cardiology, Attikon University Hospital, Athens, Greece, and University of Cyprus, Medical School, Nicosia, Cyprus.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Nowack', 'Affiliation': 'Research and Development, Clinical Development Operations, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kolkhof', 'Affiliation': 'Research and Development, Preclinical Research Cardiovascular, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'Research and Development, Clinical Development, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mentenich', 'Affiliation': 'Research and Development, Statistics and Data Insights, Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000503712']
228,32144493,Spot urinary sodium in acute decompensation of advanced heart failure and dilutional hyponatremia: insights from DRAIN trial.,"BACKGROUND


Diuretic resistance portends a poor prognosis in acute heart failure, especially in advanced stages. Early identification of a poor response to diuretics may help to improve treatment and outcomes. Spot natriuresis (UNa + ) at 2 h from the start of intravenous furosemide has been proposed as an early indicator of diuretic response. Our paper aimed to determine the role of early natriuresis in patients hospitalized with advanced chronic heart failure (ACHF) and high risk of diuretic resistance.
METHODS AND RESULTS


We performed a sub-analysis of the DRAIN trial, a randomized clinical trial on 80 patients with acute decompensation of ACHF (NYHA IV, EF ≤ 30%) with low systolic blood pressure (≤ 110 mmHg) and dilutional hyponatremia (sodium ≤ 135 mMol/L) at admission. Patients were divided into two groups according to spot urinary sodium excretion (high: UNa +   > 50 or low: ≤ 50 mEq/L) at 2 h from furosemide administration. Twenty-eight patients (35%) showed a low natriuretic response. As compared to the other patients, this group showed lower daily urinary output (2275 ± 790 vs 3849 ± 2034 mL, p < 0.001), lower body weight reduction after 48 h (1.55 ± - 1.66 vs - 3.55 ± - 2.93 kg, p < 0.001), higher incidence of worsening renal function (32% vs 10%, p 0.02) and increasing rather than reducing NT-proBNP at 72 h (p 0.02).
CONCLUSIONS


In patients with ACHF and dilutional hyponatremia, low natriuresis after furosemide is an early marker of poor diuretic response and correlates with higher NT-proBNP and higher incidence of worsening renal function at 72 h.",2020,"As compared to the other patients, this group showed lower daily urinary output (2275 ± 790 vs 3849 ± 2034 mL, p < 0.001), lower body weight reduction after 48 h (1.55 ± - 1.66 vs - 3.55 ± - 2.93 kg, p < 0.001), higher incidence of worsening renal function (32% vs 10%, p 0.02) and increasing rather than reducing NT-proBNP at 72 h (p 0.02).
","['patients hospitalized with advanced chronic heart failure (ACHF) and high risk of diuretic resistance', 'acute decompensation of advanced heart failure and dilutional hyponatremia', '80 patients with acute decompensation of ACHF (NYHA IV, EF\u2009≤\u200930%) with low systolic blood pressure (≤\u2009110\xa0mmHg) and dilutional hyponatremia (sodium\u2009≤\u2009135 mMol/L) at admission']","['furosemide', 'Spot natriuresis (UNa + ', 'Spot urinary sodium', 'spot urinary sodium excretion (high: UNa + \u2009\u2009>\u200950 or low:\u2009≤\u200950\xa0mEq/L) at 2\xa0h from furosemide administration']","['lower body weight reduction', 'lower daily urinary output', 'worsening renal function', 'low natriuretic response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation (finding)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0585109', 'cui_str': 'Dilutional hyponatremia (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0027477', 'cui_str': 'Natriuresis'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439375', 'cui_str': 'mEq/L'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0232856', 'cui_str': 'Urinary output'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",80.0,0.0632814,"As compared to the other patients, this group showed lower daily urinary output (2275 ± 790 vs 3849 ± 2034 mL, p < 0.001), lower body weight reduction after 48 h (1.55 ± - 1.66 vs - 3.55 ± - 2.93 kg, p < 0.001), higher incidence of worsening renal function (32% vs 10%, p 0.02) and increasing rather than reducing NT-proBNP at 72 h (p 0.02).
","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Galluzzo', 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza University Hospital of Turin, Corso Bramante 88, 10126, Torino, Italy. alessandro.galluzzo@unito.it.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Frea', 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza University Hospital of Turin, Corso Bramante 88, 10126, Torino, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Boretto', 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza University Hospital of Turin, Corso Bramante 88, 10126, Torino, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Pidello', 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza University Hospital of Turin, Corso Bramante 88, 10126, Torino, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Volpe', 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza University Hospital of Turin, Corso Bramante 88, 10126, Torino, Italy.'}, {'ForeName': 'Federico Giovanni', 'Initials': 'FG', 'LastName': 'Canavosio', 'Affiliation': 'Division of Anestesiology, Città della Salute e della Scienza University Hospital of Turin, Corso Bramante 88, 10126, Torino, Italy.'}, {'ForeName': 'Pier Giorgio', 'Initials': 'PG', 'LastName': 'Golzio', 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza University Hospital of Turin, Corso Bramante 88, 10126, Torino, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Bergerone', 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza University Hospital of Turin, Corso Bramante 88, 10126, Torino, Italy.'}, {'ForeName': 'Gaetano Maria', 'Initials': 'GM', 'LastName': 'De Ferrari', 'Affiliation': 'Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza University Hospital of Turin, Corso Bramante 88, 10126, Torino, Italy.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01617-w']
229,31888732,"INtervention for Cognitive Reserve Enhancement in delaying the onset of Alzheimer's Symptomatic Expression (INCREASE), a randomized controlled trial: rationale, study design, and protocol.","BACKGROUND


The course of Alzheimer's disease (AD) includes a 10-20-year preclinical period with progressive accumulation of amyloid β (Aβ) plaques and neurofibrillary tangles in the absence of symptomatic cognitive or functional decline. The duration of this preclinical stage in part depends on the rate of pathologic progression, which is offset by compensatory mechanisms, referred to as cognitive reserve (CR). Comorbid medical conditions, psychosocial stressors, and inappropriate medication use may lower CR, hastening the onset of symptomatic AD. Here, we describe a randomized controlled trial (RCT) designed to test the efficacy of a medication therapy management (MTM) intervention to reduce inappropriate medication use, bolster cognitive reserve, and ultimately delay symptomatic AD.
METHODS/DESIGN


Our study aims to enroll 90 non-demented community-dwelling adults ≥ 65 years of age. Participants will undergo positron emission tomography (PET) scans, measuring Aβ levels using standardized uptake value ratios (SUVr). Participants will be randomly assigned to MTM intervention or control, stratified by Aβ levels, and followed for 12 months via in-person and telephone visits. Outcomes of interest include: (1) medication appropriateness (measured with the Medication Appropriateness Index (MAI)); (2) scores from Trail Making Test B (TMTB), Montreal Cognitive Assessment (MoCA), and California Verbal Learning Test (CVLT); (3) perceived health status (measured with the SF-36). We will also evaluate pre- to post-intervention change in: (1) use of inappropriate medications as measured by MAI; 2) CR Change Score (CRCS), defined as the difference in scopolamine-challenged vs unchallenged cognitive scores at baseline and follow-up. Baseline Aβ SUVr will be used to examine the relative impact of preclinical AD (pAD) pathology on CRCS, as well as the interplay of amyloid burden with inappropriate medication use.
DISCUSSION


This manuscript describes the protocol of INCREASE (""INtervention for Cognitive Reserve Enhancement in delaying the onset of Alzheimer's Symptomatic Expression""): a randomized controlled trial that investigates the impact of deprescribing inappropriate medications and optimizing medication regimens on potentially delaying the onset of symptomatic AD and AD-related dementias.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02849639. Registered on 29 July 2016.",2019,"Participants will be randomly assigned to MTM intervention or control, stratified by Aβ levels, and followed for 12 months via in-person and telephone visits.","['65\u2009years of age', ""Alzheimer's Symptomatic Expression"", 'enroll 90 non-demented community-dwelling adults ≥']","['MTM intervention or control, stratified by Aβ levels, and followed for 12\u2009months via in-person and telephone visits', 'medication therapy management (MTM) intervention', 'INtervention']","['CR Change Score (CRCS', 'positron emission tomography (PET) scans, measuring Aβ levels using standardized uptake value ratios (SUVr', 'Outcomes of interest include: (1) medication appropriateness (measured with the Medication Appropriateness Index (MAI)); (2) scores from Trail Making Test B (TMTB), Montreal Cognitive Assessment (MoCA), and California Verbal Learning Test (CVLT); (3) perceived health status (measured with the SF-36']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0441633'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3496286'}, {'cui': 'C0589055', 'cui_str': 'TOMAL'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",,0.205979,"Participants will be randomly assigned to MTM intervention or control, stratified by Aβ levels, and followed for 12 months via in-person and telephone visits.","[{'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Moga', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, Lexington, KY, USA. daniela.moga@uky.edu.'}, {'ForeName': 'Brooke F', 'Initials': 'BF', 'LastName': 'Beech', 'Affiliation': 'Sanders-Brown Center on Aging, Lexington, KY, USA.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Abner', 'Affiliation': 'Department of Epidemiology, College of Public Health, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Frederick A', 'Initials': 'FA', 'LastName': 'Schmitt', 'Affiliation': 'Sanders-Brown Center on Aging, Lexington, KY, USA.'}, {'ForeName': 'Riham H', 'Initials': 'RH', 'LastName': 'El Khouli', 'Affiliation': 'Department of Radiology, College of Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Ashley I', 'Initials': 'AI', 'LastName': 'Martinez', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Eckmann', 'Affiliation': 'PRO2RX LLC Pharmacy Consulting Services, Lexington, KY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Huffmyer', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Rosmy', 'Initials': 'R', 'LastName': 'George', 'Affiliation': 'Sanders-Brown Center on Aging, Lexington, KY, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Jicha', 'Affiliation': 'Sanders-Brown Center on Aging, Lexington, KY, USA.'}]",Trials,['10.1186/s13063-019-3993-0']
230,31946656,Evaluation of the impact of extrinsic rewards on user engagement in a health promotion context.,"Despite the many mHealth solutions available, it remains unclear what their success factors are. Specifically, there has been controversy on the effectiveness of extrinsic rewards. This study evaluates two design elements of an mHealth solution - i.e., social proof and tangible rewards - and their impact on user engagement. During a four-week campaign, a sample of 143 university staff members engaged in a health promotion campaign. Participants were randomly distributed over one of three treatment groups. It was found that the introduction of a sufficiently meaningful, unexpected, and customized extrinsic reward can engage participants significantly more in a health promotion context.",2019,"It was found that the introduction of a sufficiently meaningful, unexpected, and customized extrinsic reward can engage participants significantly more in a health promotion context.",['143 university staff members engaged in a health promotion campaign'],[],[],"[{'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]",[],[],,0.0176109,"It was found that the introduction of a sufficiently meaningful, unexpected, and customized extrinsic reward can engage participants significantly more in a health promotion context.","[{'ForeName': 'Raoul C Y', 'Initials': 'RCY', 'LastName': 'Nuijten', 'Affiliation': ''}, {'ForeName': 'Pieter M E', 'Initials': 'PME', 'LastName': 'Van Gorp', 'Affiliation': ''}, {'ForeName': 'Uzay', 'Initials': 'U', 'LastName': 'Kaymak', 'Affiliation': ''}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Simons', 'Affiliation': ''}, {'ForeName': 'Astrid D A M', 'Initials': 'ADAM', 'LastName': 'Kemperman', 'Affiliation': ''}, {'ForeName': 'Pauline E W', 'Initials': 'PEW', 'LastName': 'Van den Berg', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2019.8856296']
231,31987975,"Randomized, Placebo-Controlled Clinical Trial Combining Pentoxifylline-Tocopherol and Clodronate in the Treatment of Radiation-Induced Plexopathy.","PURPOSE


Radiation-induced (RI) plexopathy is a rare peripheral nerve injury after radiation therapy for cancer. No treatment has been shown to slow its progression. A pentoxifylline-vitamin E combination significantly reduced RI fibrosis, and its association with clodronate (PENTOCLO) allowed healing of osteoradionecrosis and reduction of neurologic symptoms in phase 2 trials.
METHODS AND MATERIALS


A placebo-controlled, double-blind trial conducted in adults with RI limb plexopathy without cancer recurrence, randomized in 2 arms to PENTOCLO (pentoxifylline 800 mg, tocopherol 1000 mg, clodronate 1600 mg 5 days per week) or triple placebo. The primary outcome measure after 18 months of treatment was the neurologic Subjective Objective Management Analytic (SOMA) score evaluating pain, paresthesia, and motor disability.
RESULTS


Between 2011 and 2015, 59 patients were included: 1 false inclusion (neoplastic plexopathy), 29 treated with placebo (group P), and 29 treated with the active drugs (group A); 46 patients presented an upper-limb and 12 a lower-limb plexopathy. The mean delay after irradiation was 26 ± 8 years, for patients with neurologic symptoms for 5 ± 5 years. The median global SOMA scores in the P and A groups, respectively, were 9 (range, 6-11) versus 9 (range, 8-11) at M 0  and 9 (range, 5-12) versus 10 (range, 6-11) at M 18  without any significant difference. Analysis of the secondary outcomes showed that SOMA score subdomains for pain and paresthesia were more affected in group A (not significant). The frequency of adverse events was similar in the 2 groups (81% of patients): slight expected vascular-gastrointestinal symptoms in A, but a large excess of RI complications (arterial stenosis).
CONCLUSIONS


This first randomized drug trial in RI plexopathy failed to show a beneficial effect. More studies are needed in patients with less advanced disease and fewer confounding comorbidities and with a more sensitive measure to detect a therapeutic effect.",2020,"The frequency of adverse events was similar in the 2 groups (81% of patients): a slight expected vascular- gastro-intestinal symptoms in A, but a large excess of RI complications (arterial stenosis).
","['group P) and 29 treated with the active drugs (group A); 46 patients presented an upper limb and 12 a lower limb plexopathy', 'adults with RI limb plexopathy without cancer recurrence', 'Between 2011 and 2015, 59 patients were included: 1 false inclusion (neoplastic plexopathy), 29 treated with']","['Placebo', 'Pentoxifylline-Tocopherol And Clodronate', 'Radiation-induced (RI) plexopathy', 'placebo', 'pentoxifylline 800 mg, tocopherol 1000 mg, clodronate 1600 mg 5 days/7) or triple placebo', 'clodronate', 'pentoxifylline-vitamin E combination', 'radiotherapy (RT']","['SOMA score subdomains for pain and paresthesia', 'RI fibrosis', 'median global SOMA scores', 'frequency of adverse events', 'vascular- gastro-intestinal symptoms', 'neurological Subjective Objective Management Analytic (SOMA) score evaluating pain, paresthesia, and motor disability']","[{'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0162357', 'cui_str': 'Clodronate'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0702216', 'cui_str': 'Soma'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",59.0,0.437193,"The frequency of adverse events was similar in the 2 groups (81% of patients): a slight expected vascular- gastro-intestinal symptoms in A, but a large excess of RI complications (arterial stenosis).
","[{'ForeName': 'Sylvie E', 'Initials': 'SE', 'LastName': 'Delanian', 'Affiliation': 'Groupe Hospitalier Universitaire, APHP site Saint-Louis-Université de Paris, Oncologie-Radiothérapie, Paris, France. Electronic address: sylvie.delanian@aphp.fr.'}, {'ForeName': 'Timothee', 'Initials': 'T', 'LastName': 'Lenglet', 'Affiliation': 'Groupe Hospitalier Universitaire, APHP site Pitié-Salpêtrière- Sorbonne Université, Electrophysiologie, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Maisonobe', 'Affiliation': 'Groupe Hospitalier Universitaire, APHP site Pitié-Salpêtrière- Sorbonne Université, Electrophysiologie, Paris, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Resche-Rigon', 'Affiliation': 'Groupe Hospitalier Universitaire, APHP site Saint-Louis-Université de Paris, Biostatistiques DBIM, Paris, France.'}, {'ForeName': 'Pierre-Francois', 'Initials': 'PF', 'LastName': 'Pradat', 'Affiliation': ""Groupe Hospitalier Universitaire, APHP site Pitié-Salpêtrière-Sorbonne Université, Neurologie and CNRS-INSERM, Laboratoire d'Imagerie Biomédicale, Paris, France.""}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.01.002']
232,32004582,Erectile Dysfunction and Absorbed Dose to Penile Base Structures in a Randomized Trial Comparing Ultrahypofractionated and Conventionally Fractionated Radiation Therapy for Prostate Cancer.,"PURPOSE


To study the relationships between absorbed dose to penile base structures and erectile dysfunction (ED) in patients treated with ultrahypofractionated (UHF) radiation therapy (RT) or conventionally fractionated (CF) RT for prostate cancer.
METHODS AND MATERIALS


This dose-response study comprises 673 patients (57%) of the 1180 per-protocol patients included in the HYPO-RT-PC trial (median follow-up 5, years), where patients were randomized to CF (39 × 2.0 Gy, 8 weeks) or UHF (7 × 6.1 Gy, 2.5 weeks). No androgen deprivation therapy was allowed. Only patients with erectile function sufficient for intercourse at baseline and complete RT data were included in this study. Erectile function was assessed by physician at regular follow-ups. The main endpoint was severe ED (ED s ). The penile bulb (PB) and crus were retrospectively delineated on the treatment planning computed tomography scans. Dose-volume descriptors were derived from EQD2 converted dose matrices (α/β = 3 Gy). Univariable and multivariable Cox proportional hazard regression and logistic regression were used to find predictors for ED S .
RESULTS


No significant difference in ED s  was found between CF and UHF. During the follow-up period, ED s  occurred in 27% of the patients in both treatment groups. Average (median) PB mean dose, D mean,  was 24.5 (20.2) in CF and 18.7 (13.1) Gy 3  in UHF. Age was the only significant predictor for ED s  in Cox analyses. All dose-volume variables contributed significantly in univariable logistic regression at 2-year follow-up. Age and near maximum dose (D 2% ) were significant predictors for ED s  in multivariable logistic regression analyses at both 1 and 2 years.
CONCLUSIONS


The frequency of ED S  was similar in the CF and UHF treatment groups. Age at radiation therapy was the strongest predictor for ED s , followed by dose to PB, and was most evident for younger patients. We propose D 2 %  <50 Gy 3  and D mean  <20 Gy 3  to the PB as the primary objectives to be applied in the treatment planning process.",2020,No significant difference in ED s  was found between CF and UHF.,"['Only patients with erectile function enough for intercourse at baseline and complete RT data', '673 patients (57%) of the 1180 per-protocol patients included in the', 'prostate cancer', 'patients treated with']","['ultra-hypofractionated and conventionally fractionated radiotherapy', 'XXXXXXXXXX', 'ultra-hypofractionated (UHF) radiotherapy (RT) or conventionally fractionated (CF) RT', 'CF']","['severe ED (ED s ', 'Erectile function', 'Erectile dysfunction', 'ED s', 'Average (median', 'frequency of ED S']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0336951,No significant difference in ED s  was found between CF and UHF.,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Rasmusson', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skane University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Oncology and Pathology, Lund University, Lund, Sweden. Electronic address: elisabeth.rasmusson@med.lu.se.'}, {'ForeName': 'Adalsteinn', 'Initials': 'A', 'LastName': 'Gunnlaugsson', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skane University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Oncology and Pathology, Lund University, Lund, Sweden.'}, {'ForeName': 'Elinore', 'Initials': 'E', 'LastName': 'Wieslander', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Höglund', 'Affiliation': 'Department of Laboratory Medicine, Faculty of Medicine, Clinical Pharmacology, Lund University, Lund, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Widmark', 'Affiliation': 'Department of Oncology, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Fransson', 'Affiliation': 'Department of Nursing, Umeå University Umeå, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kjellén', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skane University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Oncology and Pathology, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nilsson', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skane University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Radiation Physics, Lund University, Lund, Sweden.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.01.022']
233,32275771,The Effects of Weak and Strong CYP3A Induction by Rifampicin on the Pharmacokinetics of Five Progestins and Ethinylestradiol Compared to Midazolam.,"It is known that co-administration of CYP3A inducers may decrease the effectiveness of oral contraceptives containing progestins as mono-preparations or combined with ethinylestradiol. In a randomized clinical drug-drug interaction study, we investigated the effects of CYP3A induction on the pharmacokinetics of commonly used progestins and ethinylestradiol. Rifampicin was used to induce CYP3A. The progestins chosen as victim drugs were levonorgestrel, norethindrone, desogestrel, and dienogest as mono-products, and drospirenone combined with ethinylestradiol. Postmenopausal women (n = 12-14 per treatment group) received, in fixed sequence, a single dose of the victim drug plus midazolam without rifampicin, with rifampicin 10 mg/day (weak induction), and with rifampicin 600 mg/day (strong induction). The effects on progestin exposure were compared with the effects on midazolam exposure (as a benchmark). Unbound concentrations were evaluated for drugs binding to sex hormone binding globulin. Weak CYP3A induction, as confirmed by a mean decrease in midazolam exposure by 46%, resulted in minor changes in progestin exposure (mean decreases: 15-37%). Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%). Namely, the magnitude of the observed induction effects varied from weak to strong. Our data might provide an impetus to revisit the currently applied clinical recommendations for oral contraceptives, especially for levonorgestrel and norethindrone-containing products, and they might give an indication as to which progestin could be used, if requested, by women taking weak CYP3A inducers-although it is acknowledged that the exact exposure-response relationship for contraceptive efficacy is currently unclear for most progestins.",2020,"Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%).",['Postmenopausal women (n=12-14 per treatment group'],"['rifampicin', 'Rifampicin', 'levonorgestrel, norethindrone, desogestrel, and dienogest as mono-products and drospirenone combined with ethinylestradiol', 'CYP3A induction', 'ethinylestradiol', 'victim drug plus midazolam without rifampicin, with rifampicin 10 mg/d (weak induction), and with rifampicin 600 mg/d (strong induction', 'midazolam', 'CYP3A']",[],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0028356', 'cui_str': 'Norethindrone'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0442821', 'cui_str': 'Strong'}]",[],,0.0299347,"Strong CYP3A induction, in contrast, resulted in mean decreases by 57-90% (mean decrease in midazolam exposure: 86%).","[{'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Wiesinger', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Rottmann', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Nowotny', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Riecke', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Gashaw', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Margarete', 'Initials': 'M', 'LastName': 'Brudny-Klöppel', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fricke', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Höchel', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Friedrich', 'Affiliation': 'Bayer AG, Berlin, Germany.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1848']
234,32260466,"Effect of  Schisandra Chinensis  Extract Supplementation on Quadriceps Muscle Strength and Fatigue in Adult Women: A Randomized, Double-Blind, Placebo-Controlled Trial.","The fruit of  Schisandra chinensis  (SC) is a well-known traditional herb used for pharmacological purposes in Asian countries (e.g., Korea, China, and Japan). In animal studies, SC extract supplementation had beneficial effects on muscle strength and lactate level. However, the effect of SC extract supplementation on skeletal muscle strength and lactate at rest in humans remains unclear. The purpose of this study was to evaluate the effect of SC extract supplementation on quadriceps muscle strength (QMS) and lactate at rest in adult women. Forty five healthy post-menopausal middle-aged women (61.9 ± 8.4 years) were randomly divided into the SC ( n  = 24) or the placebo group ( n  = 21). The SC group consumed 1000 mg of SC extract per day, whereas the placebo group consumed 1000 mg of starch per day for 12 weeks. The difference in muscle mass, physical function, and biomarkers and the relative changes between baseline and 12 weeks were evaluated. We used two-factor repeated measures analysis of variance (ANOVA) to determine interaction (group × time) effects for variables. Statistical significance was accepted at  p  < 0.05. In ANOVA results, QMS ( p  = 0.001) and lactate level ( p  = 0.038) showed significant interactions. With paired t-tests, QMS was significantly increased ( p  < 0.001) and lactate level at rest was significantly decreased ( p  < 0.05) after 12 weeks in the SC group. However, no interactions were found between the other variables. Supplementation of SC extract may help to improve QMS as well as decrease lactate level at rest in adult women. We believe that SC extract is a health supplement that can support healthy life in this population.",2020,"In ANOVA results, QMS ( p  = 0.001) and lactate level ( p  = 0.038) showed significant interactions.","['Adult Women', 'adult women', 'Forty five healthy post-menopausal middle-aged women (61.9 ± 8.4 years']","['placebo', 'SC', 'SC extract supplementation', 'Schisandra Chinensis  Extract Supplementation', 'Placebo']","['muscle mass, physical function, and biomarkers and the relative changes', 'quadriceps muscle strength (QMS) and lactate at rest', 'lactate level at rest', 'skeletal muscle strength and lactate', 'Quadriceps Muscle Strength and Fatigue', 'lactate level', 'muscle strength and lactate level', 'QMS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0696946', 'cui_str': 'Wu wei zi'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0224440', 'cui_str': 'Structure of quadriceps femoris muscle'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.33307,"In ANOVA results, QMS ( p  = 0.001) and lactate level ( p  = 0.038) showed significant interactions.","[{'ForeName': 'Jinkee', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Sport Rehabilitation, Dong Ju College, Busan 49318, Korea.'}, {'ForeName': 'Seoungho', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Family Medicine, College of Medicine, Dong-A University, Busan 49201, Korea.'}, {'ForeName': 'Hyuntae', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Health Care and Science, Dong-A University, Busan 49315, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17072475']
235,31429023,HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study.,"PURPOSE


Currently available local anesthetics have not demonstrated sufficient analgesia beyond 12-24 h postoperatively. The purpose of the study was to assess the safety and efficacy of HTX-011 (bupivacaine and meloxicam in Biochronomer ®  polymer technology), a long-acting investigational anesthetic, in reducing both postoperative pain over 72 h and postoperative opioid use compared to bupivacaine hydrochloride (HCl).
METHODS


A phase 3, randomized, double-blind, active-controlled multi-center study (EPOCH 2; NCT03237481) in subjects undergoing unilateral open inguinal herniorrhaphy with mesh placement was performed. Subjects randomly received a single intraoperative dose of HTX-011, immediate-release bupivacaine HCl, or saline placebo prior to closure.
RESULTS


The study evaluated 418 subjects, and the primary and all key secondary efficacy endpoints were in favor of HTX-011. HTX-011 reduced mean pain intensity by 23% versus placebo (primary endpoint; p < 0.001) and by 21% versus bupivacaine HCl (p < 0.001) with significant reductions in the number of patients experiencing severe pain. Opioid consumption over 72 h was reduced by 38% versus placebo (p < 0.001) and 25% versus bupivacaine HCl (p = 0.024). Overall, 51% of HTX-011 subjects were opioid-free through 72 h (versus 22% for placebo [p < 0.001] and 40% for bupivacaine HCl [p = 0.049]). HTX-011 was generally well-tolerated with fewer opioid-related adverse events reported compared to the bupivacaine HCl and placebo and no evidence of local anesthetic systemic toxicity.
CONCLUSIONS


HTX-011 demonstrated significant improvement in postoperative pain control and a clinically meaningful reduction in opioid consumption when compared to the most widely used local anesthetic, bupivacaine HCl.",2019,reduced mean pain intensity by 23% versus placebo (primary endpoint; p < 0.001) and by 21% versus bupivacaine HCl (p < 0.001) with significant reductions in the number of patients experiencing severe pain.,"['herniorrhaphy', 'subjects undergoing']","['bupivacaine HCl and placebo', 'bupivacaine HCl', 'unilateral open inguinal herniorrhaphy with mesh placement', 'placebo', 'bupivacaine hydrochloride (HCl', 'HTX-011', 'HTX-011 (bupivacaine and meloxicam', 'single intraoperative dose of HTX-011, immediate-release bupivacaine HCl, or saline placebo']","['mean pain intensity', 'pain intensity and opioid consumption', 'Opioid consumption', 'opioid-free', 'postoperative pain control', 'safety and efficacy']","[{'cui': 'C0019328', 'cui_str': 'Hernia Repair'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0443985', 'cui_str': 'Flinders medical center-7 marker (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",418.0,0.391164,reduced mean pain intensity by 23% versus placebo (primary endpoint; p < 0.001) and by 21% versus bupivacaine HCl (p < 0.001) with significant reductions in the number of patients experiencing severe pain.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Viscusi', 'Affiliation': 'Sidney Kimmel Medical College of Thomas Jefferson University, 111 South 11th Street, Gibbon Building, Suite 8490, Philadelphia, PA, 19107, USA. Eugene.Viscusi@jefferson.edu.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Minkowitz', 'Affiliation': 'HD Research Corp, Houston, TX, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ramamoorthy', 'Affiliation': 'University of California at San Diego Health System, San Diego, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Heron Therapeutics, Inc., San Diego, CA, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Lotus Clinical Research, LLC, Pasadena, CA, USA.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-019-02023-6']
236,32278771,Randomized Trial of Monthly Versus As-Needed Intravitreal Ranibizumab for Radiation Retinopathy-Related Macular Edema: 1-Year Outcomes.,"PURPOSE


To assess efficacy of intravitreal ranibizumab injections and targeted panretinal photocoagulation (TRP) for radiation retinopathy-related macular edema.
DESIGN


Phase IIb, prospective, randomized clinical trial.
METHODS


Setting: Multicenter.
SUBJECTS


Forty eyes in 40 treatment-naïve patients with radiation-induced macular edema and a resulting decrease in visual acuity ranging between 20/25 and 20/400 (Snellen equivalent).
INTERVENTION


Patients either received intravitreal 0.5 mg ranibizumab monthly, monthly ranibizumab with TRP, or 3 monthly ranibizumab (loading doses) followed by as-needed (PRN) injections and TRP. After week 52, all subjects entered a treat-and-extend protocol for ranibizumab. MainOutcomeMeasures: Mean Early Treatment Diabetic Maculopathy Study (ETDRS) BCVA change from baseline.
RESULTS


Mean patient age was 57 years (range, 22-80 years), ETDRS BCVA was 56.7 letters (20/74 Snellen equivalent), and central macular thickness (CMT) was 423 μm (range, 183-826 μm). Thirty-seven patients completed the month 12 visit (92.5%), at which time the change in mean BCVA was +4.0 letters, -1.9 letters, and +0.9 letters in the monthly, monthly plus laser, and PRN plus laser cohorts, respectively. There was a significant difference in mean BCVA at 1 year among all 3 cohorts (P < .001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group. A total of 82.5% of the patients retained visual acuity of 20/200 or better, and 20.0% improved 10 or more ETDRS letters.
CONCLUSIONS


Ranibizumab may improve vision and anatomy in patients with radiation retinopathy-related macular edema and prevent vision loss through 48 weeks of therapy. Monthly injections were more effective than as-needed approach, and the addition of TRP yielded no therapeutic benefits.",2020,"There was a significant difference in mean BCVA at 1 year among all three cohorts (p<0.001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group.","['Mean patient age was 57 years (range, 22-80), ETDRS BCVA was 56.7 letters (20/74 Snellen-equivalent), and central macular thickness (CMT) was 423 um (range, 183-826', 'multi-center PATIENTS: 40 eyes in 40 treatment-naïve patients with radiation-induced macular edema and a resulting decrease in visual acuity ranging between 20/25 and 20/400 (Snellen-equivalent', 'patients with radiation retinopathy-related macular edema', 'Radiation Retinopathy-Related Macular Edema']","['intravitreal ranibizumab injections and targeted pan-retinal photocoagulation (TRP', 'intravitreal 0.5mg ranibizumab monthly, monthly ranibizumab with TRP, or 3 monthly ranibizumab (loading doses) followed by as-needed (PRN) injections and TRP', 'Ranibizumab', 'ranibizumab', 'Intravitreal Ranibizumab']","['mean BCVA', 'Mean ETDRS', 'visual acuity', 'vision and anatomy', 'BCVA change']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1690939', 'cui_str': '20/25'}, {'cui': 'C0442765', 'cui_str': '20/400'}, {'cui': 'C0339483', 'cui_str': 'Radiation retinopathy'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.124777,"There was a significant difference in mean BCVA at 1 year among all three cohorts (p<0.001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group.","[{'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Schefler', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, USA; Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas, USA. Electronic address: acsmd@houstonretina.com.'}, {'ForeName': 'Dwain', 'Initials': 'D', 'LastName': 'Fuller', 'Affiliation': 'Texas Retina Associates, Dallas, Texas, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Anand', 'Affiliation': 'Texas Retina Associates, Dallas, Texas, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Fuller', 'Affiliation': 'Texas Retina Associates, Dallas, Texas, USA.'}, {'ForeName': 'Chelsey', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Munoz', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, USA.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Kim', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, USA; McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.03.045']
237,32132141,Safety of Liraglutide in Type 2 Diabetes and Chronic Kidney Disease.,"BACKGROUND AND OBJECTIVES


The glucagon-like peptide-1 receptor agonist liraglutide demonstrated cardiovascular and kidney benefits in the LEADER trial, particularly in participants with CKD.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


This  post hoc  analysis evaluated the safety of liraglutide treatment in patients with CKD in LEADER. Overall, 9340 patients were randomized to liraglutide or placebo, both in addition to standard of care. Of those, 2158 patients had CKD versus 7182 without CKD (defined as eGFR <60 versus ≥60 ml/min per 1.73 m 2 , respectively); 966 patients had macroalbuminuria and 2456 had microalbuminuria (urine albumin-creatinine ratio >300 mg/g and ≥30 to ≤300 mg/g, respectively). At baseline, the mean eGFR in patients with CKD was 46±11 ml/min per 1.73 m 2  versus 91±22 ml/min per 1.73 m 2  in those without CKD. Time to first event within event groups was analyzed using Cox regression with treatment group, baseline eGFR group, or baseline albuminuria group as fixed factors.
RESULTS


Overall, serious adverse events were more frequently recorded in patients with CKD compared with those without CKD (59% versus 50%; interaction  P =0.11); however, they occurred to the same extent in those on liraglutide versus placebo. Similarly, no interaction of adverse events with randomized therapy was observed in patients with micro- or macro- versus normoalbuminuria (interaction  P =0.11). Risk of severe hypoglycemia was significantly reduced with liraglutide versus placebo in patients with CKD or with micro- or macroalbuminuria (hazard ratio, 0.63 [95% CI, 0.43 to 0.91] and 0.57 [95% CI, 0.40 to 0.82], respectively).
CONCLUSIONS


In LEADER, the use of liraglutide in those with CKD was safe, with no difference between patients with and without CKD.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


ClinicalTrials.gov; NCT01179048 (https://clinicaltrials.gov/ct2/show/NCT01179048).",2020,"Risk of severe hypoglycemia was significantly reduced with liraglutide versus placebo in patients with CKD or with micro- or macroalbuminuria (hazard ratio, 0.63","['patients with CKD in LEADER', '2158 patients had CKD versus 7182 without CKD (defined as eGFR <60 versus ≥60 ml/min per 1.73 m 2 , respectively); 966 patients had macroalbuminuria and 2456 had microalbuminuria', 'Type 2 Diabetes and Chronic Kidney Disease', 'patients with CKD or with micro- or macroalbuminuria (hazard ratio, 0.63', '9340 patients', 'participants with CKD']","['Liraglutide', 'liraglutide', 'liraglutide or placebo', 'placebo']","['Risk of severe hypoglycemia', 'mean eGFR', 'Overall, serious adverse events', 'adverse events', 'urine albumin-creatinine ratio ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4517468', 'cui_str': '0.63'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",9340.0,0.224318,"Risk of severe hypoglycemia was significantly reduced with liraglutide versus placebo in patients with CKD or with micro- or macroalbuminuria (hazard ratio, 0.63","[{'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center, Munich, Germany; prof.j.mann@gmail.com.'}, {'ForeName': 'Vivian A', 'Initials': 'VA', 'LastName': 'Fonseca', 'Affiliation': 'Tulane University Health Sciences Center, School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Poulter', 'Affiliation': 'School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel; and.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Bernt Johan', 'Initials': 'BJ', 'LastName': 'von Scholten', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel; and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.11881019']
238,31368861,"Effect of Steamed Onion (ONIRO) Consumption on Body Fat and Metabolic Profiles in Overweight Subjects: A 12-Week Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","Objective : The aim of the study is to investigate the effect of Jeju steamed onion (ONIRO) on body fat and metabolic profiles in overweight subjects. Methods:  This randomized, double-blind, placebo-controlled clinical intervention was conducted and completed at one clinical research site. The subjects ( n  = 70) were randomly divided into placebo or test group and were instructed to take before each meal either the placebo or ONIRO capsule for 12 weeks. Anthropometric as well as serum and metabolic parameters, including triglycerides, cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, leptin, adiponectin, C-peptide, and aspartate aminotransferase (AST) were measured at baseline and after 12 weeks. Body composition was also measured by dual-energy x-ray absorptiometry (DEXA) and computed tomography (CT). This trial is registered under the trial registration code clinicaltrials.gov: NCT03645382 (https://register.clinicaltrials.gov). Results:  Compared to the placebo, ONIRO supplementation for significantly reduced the percentage of body fat and fat mass as measured by DEXA ( p  = 0.028 and 0.022, respectively) with no significant effects on lean body mass. CT analyses at the L1 level showed a significant decrease in the areas of whole fat, visceral fat, and subcutaneous fat ( p  = 0.009,  p  = 0.039,  p  = 0.020, respectively), while CT scan of L4 resulted in a significant reduction of whole fat area and subcutaneous area ( p  = 0.006 and  p  = 0.012, respectively). The levels of triglycerides (TG) and C-peptide were significantly lower after 12 weeks of ONIRO treatment. Conclusions:  These findings suggest that ONIRO supplementation reduces total body fat, notably abdominal visceral fat, with positive changes of the clinically relevant metabolic parameters serum TG and C-peptide.",2020,"Compared to the placebo, ONIRO supplementation for significantly reduced the percentage of body fat and fat mass as measured by DEXA ( p  = 0.028 and 0.022, respectively) with no significant effects on lean body mass.","['overweight subjects', 'subjects ( n \u2009=\u200970', 'Overweight Subjects']","['placebo or ONIRO capsule', 'placebo, ONIRO supplementation', 'ONIRO supplementation', 'placebo', 'Jeju steamed onion (ONIRO', 'Steamed Onion (ONIRO) Consumption', 'Placebo']","['total body fat, notably abdominal visceral fat', 'whole fat area and subcutaneous area', 'lean body mass', 'levels of triglycerides (TG) and C-peptide', 'serum and metabolic parameters, including triglycerides, cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, leptin, adiponectin, C-peptide, and aspartate aminotransferase (AST', 'Body composition', 'body fat and metabolic profiles', 'areas of whole fat, visceral fat, and subcutaneous fat', 'Body Fat and Metabolic Profiles', 'percentage of body fat and fat mass']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0038225', 'cui_str': 'Steam'}, {'cui': 'C0029035', 'cui_str': 'Onions'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.376408,"Compared to the placebo, ONIRO supplementation for significantly reduced the percentage of body fat and fat mass as measured by DEXA ( p  = 0.028 and 0.022, respectively) with no significant effects on lean body mass.","[{'ForeName': 'Sarang', 'Initials': 'S', 'LastName': 'Jeong', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Jisuk', 'Initials': 'J', 'LastName': 'Chae', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Gahyun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Gurum', 'Initials': 'G', 'LastName': 'Shin', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Young-In', 'Initials': 'YI', 'LastName': 'Kwon', 'Affiliation': 'Department of Internal Medicine, Severance Hospital, Division of Endocrinology and Metabolism, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung-Bae', 'Initials': 'JB', 'LastName': 'Oh', 'Affiliation': 'Department of Food and Nutrition, Hannam University, Daejeon, Republic of Korea.'}, {'ForeName': 'Dong Yeob', 'Initials': 'DY', 'LastName': 'Shin', 'Affiliation': 'Institute of Functional Foods, KunpoongBio Co. Ltd, Jeju, Republic of Korea.'}, {'ForeName': 'Jong Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'National Leading Research Laboratory of Clinical Nutrigenetics/Nutrigenomics, Department of Food and Nutrition, College of Human Ecology, Yonsei University, Seoul, Korea.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1635052']
239,31388790,Telescopic dissection versus balloon dissection for laparoscopic totally extraperitoneal inguinal hernia repair (TEP): a registry-based randomized controlled trial.,"OBJECTIVE


Laparoscopic totally extraperitoneal inguinal hernia repair (TEP) can be performed using either telescopic (TD) or balloon dissection (BD). The use of a disposable balloon dissector increases the cost of TEP. However, it remains unclear whether BD saves enough time to justify its cost. We hypothesized that BD would consistently save 15 min in operative time. To test this hypothesis, we designed a registry-based randomized controlled trial (RB-RCT) embedded into the Americas Hernia Society Quality Collaborative.
METHODS


A single-blinded, parallel, RB-RCT was conducted. Adults with inguinal hernias presenting for elective repair were screened. Patients with unilateral hernias deemed fit to undergo TEP were eligible; those with bilateral hernias (BIH) or undergoing open repair were excluded. Individuals were randomized to TD or BD with a disposable device. TEP was performed with synthetic mesh and tacks. Subjects were blinded and followed up for 30 day. Main outcome was operative time.
RESULTS


207 patients were screened: 166 were excluded and 41 were randomized (21 BD, 20 TD). One patient (TD group) was excluded due to the incidental finding of BIH. 40 patients were analyzed (median age 56, median BMI 26 kg/m 2 , 98% males). Hernias were 72% indirect, 17% direct, 10% pantaloon, and 8% recurrent. Other than obesity (26.5% vs. 0, p = 0.018), there were no baseline differences between the groups. Median operative times were similar (TD 43 min, IQR 33-63; BD 46 min, IQR 35-90, p = 0.490). There were 2 seromas and 2 hematomas in the BD group, and none in the TD (p = 0.108).
CONCLUSIONS


BD does not consistently result in 15-min time saving during TEP. Use of a disposable balloon dissector can be deferred in the experienced hands.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03276871).",2019,"Median operative times were similar (TD 43 min, IQR 33-63; BD 46 min, IQR 35-90, p = 0.490).","['Patients with unilateral hernias deemed fit to undergo TEP were eligible; those with bilateral hernias (BIH) or undergoing open repair were excluded', 'Adults with inguinal hernias presenting for elective repair were screened', '207 patients were screened: 166 were excluded and 41 were randomized (21 BD, 20 TD', 'One patient (TD group) was excluded due to the incidental finding of BIH. 40 patients were analyzed (median age 56, median BMI 26\xa0kg/m 2 , 98% males']","['TEP', 'Laparoscopic totally extraperitoneal inguinal hernia repair (TEP', 'telescopic (TD) or balloon dissection (BD', 'disposable balloon dissector', 'laparoscopic totally extraperitoneal inguinal hernia repair (TEP', 'Telescopic dissection versus balloon dissection']","['operative time', 'Median operative times', 'cost of TEP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0145334', 'cui_str': 'Pyrazine, tetraethyl-'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0743997', 'cui_str': 'Incidental Findings'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0145334', 'cui_str': 'Pyrazine, tetraethyl-'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0180479', 'cui_str': 'Dissector (physical object)'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0145334', 'cui_str': 'Pyrazine, tetraethyl-'}]",207.0,0.367927,"Median operative times were similar (TD 43 min, IQR 33-63; BD 46 min, IQR 35-90, p = 0.490).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tastaldi', 'Affiliation': 'Department of General Surgery, Cleveland Clinic Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A100-133, Cleveland, OH, 44195, USA. tastall@ccf.org.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bencsath', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Hillcrest Hospital, The Cleveland Clinic Foundation, 6770 Mayfield Road, Mayfield Heights, OH, 44124, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Alaedeen', 'Affiliation': 'Department of General Surgery, Digestive Disease and Surgery Institute, Fairview Hospital, The Cleveland Clinic Foundation, 18101 Lorain Avenue, Cleveland, OH, 44111, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rosenblatt', 'Affiliation': 'Department of General Surgery, Cleveland Clinic Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A100-133, Cleveland, OH, 44195, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Alkhatib', 'Affiliation': 'Department of General Surgery, Cleveland Clinic Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A100-133, Cleveland, OH, 44195, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tu', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fafaj', 'Affiliation': 'Department of General Surgery, Cleveland Clinic Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A100-133, Cleveland, OH, 44195, USA.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Krpata', 'Affiliation': 'Department of General Surgery, Cleveland Clinic Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A100-133, Cleveland, OH, 44195, USA.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Prabhu', 'Affiliation': 'Department of General Surgery, Cleveland Clinic Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A100-133, Cleveland, OH, 44195, USA.'}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Petro', 'Affiliation': 'Department of General Surgery, Cleveland Clinic Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A100-133, Cleveland, OH, 44195, USA.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Rosen', 'Affiliation': 'Department of General Surgery, Cleveland Clinic Center for Abdominal Core Health, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A100-133, Cleveland, OH, 44195, USA.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-019-02001-y']
240,32272623,The Effect of Solution-Focused Group Counseling Intervention on College Students' Internet Addiction: A Pilot Study.,"This pilot study aimed to explore the effect of solution-focused group counseling intervention on Internet addiction among college students. Eighteen college students participated in this study, out of which nine subjects were assigned into the experimental group and the rest ( n  = 9) to a control group. The experimental group received group counseling for five weeks, while the control group did not receive any intervention. The revised version of the Chinese Internet Addiction Scale (CIAS-R) was used to capture pre-test and post-test excessive use in the two groups. The experimental group was also subjected to a follow-up test and self-reported Internet addiction scores six months after the end of group counseling. Results showed that after the five-week solution-focused group counseling, the scores of four dimensions of the CIAS-R in the experimental group had CIAS-R decreased, and the reduction trend of the total score of CIAS-R was similar across all subjects in this group. The treatment effect was larger than the placebo reduction in the control group in two dimensions: compulsive and withdrawal (Sym-C & Sym-W) and tolerance (Sym-T) symptoms. Qualitative research confirmed the conclusions from the quantitative data, showing that the experimental group reduced its Internet addiction symptoms. Overall, the findings suggested that solution-focused group counseling had positive intervention effects on Internet addiction.",2020,The treatment effect was larger than the placebo reduction in the control group in two dimensions: compulsive and withdrawal (Sym-C & Sym-W) and tolerance (Sym-T) symptoms.,"['Eighteen college students', ""College Students' Internet Addiction"", 'college students']","['solution-focused group counseling intervention', 'control group did not receive any intervention', 'Solution-Focused Group Counseling Intervention']","['Internet addiction', 'CIAS-R', 'Internet addiction symptoms', 'Chinese Internet Addiction Scale (CIAS-R', 'total score of CIAS-R']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0170509', 'cui_str': 'CyADIC protocol'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",18.0,0.0245584,The treatment effect was larger than the placebo reduction in the control group in two dimensions: compulsive and withdrawal (Sym-C & Sym-W) and tolerance (Sym-T) symptoms.,"[{'ForeName': 'Xinhe', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Psychology, Ministry of Education Key Laboratory of Cognition and Personality, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Xiaoxuan', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Faculty of Psychology, Ministry of Education Key Laboratory of Cognition and Personality, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Shuowei', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Faculty of Psychology, Ministry of Education Key Laboratory of Cognition and Personality, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Faculty of Psychology, Ministry of Education Key Laboratory of Cognition and Personality, Southwest University, Chongqing 400715, China.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Turel', 'Affiliation': 'Information Systems and Decision Sciences, California State University, Fullerton, CA 92831, USA.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Faculty of Psychology, Ministry of Education Key Laboratory of Cognition and Personality, Southwest University, Chongqing 400715, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17072519']
241,32192925,"Titanium-Prepared Platelet-Rich Fibrin Versus Connective Tissue Graft on Peri-Implant Soft Tissue Thickening and Keratinized Mucosa Width: A Randomized, Controlled Trial.","PURPOSE


The health of peri-implant tissues is associated with the peri-implant soft tissue thickness (STT) and keratinized tissue width (KTW). Resorptive changes in the crestal bone around implant sites will be affected by the STT. The present randomized prospective study compared the effectiveness of titanium-prepared platelet-rich fibrin (T-PRF) with that of connective tissue graft (CTG) on peri-implant STT, KMW, and crestal bone level.
PATIENTS AND METHODS


Through simultaneous augmentation of the soft tissue using T-PRF or CTG, 30 implants were placed in 30 patients. The implants were placed in thin, soft tissue areas and thickened simultaneously with a T-PRF membrane in the test group and a CTG in the control group. During surgery (T 0 ) and at 3 months postoperatively (T 1 ), the KTW and peri-implant STT were measured at 3 points: occlusal part of the alveolar crest (OAC), midbuccal mucosa level (MBML), and 1 mm above the mucogingival junction (MGJ1). The crestal bone changes were evaluated from a periapical radiograph at 3 months postoperatively.
RESULTS


The baseline STT and KTW measurements showed no significant differences between the 2 groups (P < .05). Comparison of the T 0  and T 1  measurements from the 2 groups showed a significant increase in KTW and STT (P < .001). Compared with the test group, the control group showed a highly significant increase in the peri-implant STT at the MBML, MGJ1, and KTW levels (P < .05). No significant difference was found between the 2 groups in terms of the OAC changes (P > .05). No crestal bone loss was observed in any of the dental implants.
CONCLUSIONS


Both groups experienced a greater increase in peri-implant STT at the OAC level, and T-PRF can be considered as an autogenous alternative to CTG. Also, peri-implant STT might prevent crestal bone resorption in the osseointegration period.",2020,"Both groups experienced a greater increase in peri-implant STT at the OAC level, and T-PRF can be considered as an autogenous alternative to CTG.","['Through simultaneous augmentation of the soft tissue using T-PRF or CTG, 30 implants were placed in 30 patients', 'Peri-Implant Soft Tissue Thickening and Keratinized Mucosa Width']","['Connective Tissue Graft', 'Titanium-Prepared Platelet-Rich Fibrin', 'connective tissue graft (CTG', 'titanium-prepared platelet-rich fibrin (T-PRF']","['peri-implant STT, KMW, and crestal bone level', 'peri-implant STT at the MBML, MGJ1, and KTW levels', 'OAC changes', 'KTW and STT', 'crestal bone resorption', 'baseline STT and KTW measurements', 'crestal bone loss', 'peri-implant STT', 'crestal bone changes']","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205400', 'cui_str': 'Thickened (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]","[{'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C4505052', 'cui_str': 'L-PRF'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",30.0,0.0285614,"Both groups experienced a greater increase in peri-implant STT at the OAC level, and T-PRF can be considered as an autogenous alternative to CTG.","[{'ForeName': 'Gülbahar', 'Initials': 'G', 'LastName': 'Ustaoğlu', 'Affiliation': 'Assistant Professor, Department of Periodontology, Faculty of Dentistry, Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Tuğçe', 'Initials': 'T', 'LastName': 'Paksoy', 'Affiliation': 'Assistant Professor, Department of Periodontology, Faculty of Dentistry, Beykent University, Istanbul, Turkey. Electronic address: tugcepaksoy@beykent.edu.tr.'}, {'ForeName': 'Kerem Çağlar', 'Initials': 'KÇ', 'LastName': 'Gümüş', 'Affiliation': 'Private Practice in Periodontology, Kocaeli, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.02.019']
242,31662162,"Acute Exercise, Psychological Stress Induction, and Episodic Memory.","Objective:  In this study, we evaluated whether exercise prior to memory encoding or during memory consolidation can influence episodic memory function after being exposed to a stressful environment.  Methods:  We conducted 3 between-group randomized controlled experiments among young adults. We assessed episodic memory (via logic memory task) at the beginning of the experiment and approximately 45 minutes later. Across the 3 experiments, we varied the temporal period (eg, before memory encoding or during consolidation) of the acute bout of exercise (15-minute moderate-intensity exercise) and psychological stress induction.  Results:  Across all 3 experiments there was a statistically significant main effect for time for memory function, but there were no time x group interaction effects.  Conclusion:  Memory declined across the 2 assessment periods, but for all 3 experiments, exercise was not associated with memory function after being exposed to a stressful stimulus.",2019,"Conclusion:  Memory declined across the 2 assessment periods, but for all 3 experiments, exercise was not associated with memory function after being exposed to a stressful stimulus.",['young adults'],['exercise prior to memory encoding or during memory consolidation'],"['episodic memory (via logic memory task', 'Acute Exercise, Psychological Stress Induction, and Episodic Memory', 'time for memory function']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0023963', 'cui_str': 'Logic'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0515074,"Conclusion:  Memory declined across the 2 assessment periods, but for all 3 experiments, exercise was not associated with memory function after being exposed to a stressful stimulus.","[{'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Loprinzi', 'Affiliation': 'Paul D. Loprinzi, University of Mississippi, Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, University of Mississippi, Shenzhen, China;, Email: pdloprin@olemiss.edu.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Koehler', 'Affiliation': 'Lauren Koehler, University of Mississippi, Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, University of Mississippi, Shenzhen, China.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Frith', 'Affiliation': 'Emily Frith, University of Mississippi, Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, University of Mississippi, Shenzhen, China.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Ponce', 'Affiliation': 'Pamela Ponce, University of Mississippi, Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, University of Mississippi, Shenzhen, China.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Delancey', 'Affiliation': 'Dylan Delancey, University of Mississippi, Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, University of Mississippi, Shenzhen, China.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Joyner', 'Affiliation': 'Chelsea Joyner, University of Mississippi, Exercise & Memory Laboratory, Department of Health, Exercise Science and Recreation Management, University of Mississippi, Shenzhen, China.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Ashpole', 'Affiliation': 'MS. Nicole Ashpole, University of Mississippi, Department of BioMolecular Sciences, School of Pharmacy, University of Mississippi, Shenzhen, China.'}, {'ForeName': 'Liye', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Liye Zou, Shenzhen University, College of Psychology and Sociology, Shenzhen, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Hong Li, Shenzhen University, College of Psychology and Sociology, Research Centre of Brain Function and Psychological Science, Shenzhen Institute of Neuroscience, Shenzhen, China;, Email: lihongszu@szu.edu.cn.'}]",American journal of health behavior,['10.5993/AJHB.43.6.1']
243,31669564,Toxicity and Biochemical Outcomes of Dose-Intensified Postoperative Radiation Therapy for Prostate Cancer: Results of a Randomized Phase III Trial.,"PURPOSE


Our purpose was to compare toxicity and biochemical control in postprostatectomy patients treated with conventional (66 Gy) or dose-intensified (72 Gy) radiation therapy.
METHODS AND MATERIALS


Patients who had stage pT3-4, positive surgical margins, or rising prostate-specific antigen ≥ 0.2 ng/mL after radical prostatectomy were randomly assigned to receive either 66 Gy in 33 fractions or 72 Gy in 36 fractions. A primary endpoint was to assess the difference in biochemical progression-free survival (bPFS) between these 2 cohorts, and secondary endpoints were to assess differences in genitourinary (GU), gastrointestinal (GI), and hematologic toxicities between these 2 cohorts. bPFS was estimated by the Kaplan-Meier method and toxicities were compared using the χ 2  test.
RESULTS


Between September 2011 and November 2016, 144 patients were enrolled: 71 patients to the 66 Gy cohort and 73 patients to the 72 Gy cohort. The median follow-up time was 48.5 months (range, 14-79 months). There was no difference in 4-year bPFS between the 66 Gy and 72 Gy cohorts (75.9% vs 82.6%; P = .299). However, in patients with a higher Gleason score (8-10), the 72 Gy cohort had statistically significant improvement in bPFS compared with the 66 Gy cohort (79.7% vs 55.7%; P = .049). Toxicity analysis showed no difference in ≥2 acute or late GI or GU toxicities between these 2 cohorts. A total of 48 patients were scored as urinary incontinence before radiation therapy, of which 39 (81.3%) reported incontinence recovery or stable at 1-year follow-up, and only 9 (18.8%) patients reported worsening. There was no difference between the 2 cohorts in urinary incontinence either at baseline or at 1-year follow-up.
CONCLUSIONS


Dose escalation (72 Gy) demonstrated no improvement in 4-year bPFS compared with the 66 Gy regimen. However, the dose escalation was not associated with greater acute or late GU or GI toxicities and did not increase urinary incontinence.",2020,"CONCLUSION


Dose escalation (72 Gy) demonstrated no improvement in 4-year bPFS compared with the 66 Gy regimen.","['Prostate Cancer', '144 patients were enrolled: 71 patients to the 66 Gy cohort and 73 patients to the 72 Gy cohort', 'Patients who had stage pT3-4, positive surgical margins, or rising PSA ≥ 0.2 ng/mL following radical prostatectomy', 'post-prostatectomy patients treated with', 'Between September 2011 and November 2016']","['Dose-Intensified Post-Operative Radiation Therapy', 'conventional (66 Gy) or dose-intensified (72 Gy) radiotherapy']","['toxicities', 'genitourinary (GU), gastrointestinal (GI), and hematologic (HT) toxicities', 'Toxicity and Biochemical Outcomes', 'biochemical progression-free survival (bPFS', 'urinary incontinence', 'acute or late GU or GI toxicities', 'incontinence recovery', 'urinary incontinence before RT', 'bPFS', '4-year bPFS', '≥2 acute or late GI or GU toxicities']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",144.0,0.0725116,"CONCLUSION


Dose escalation (72 Gy) demonstrated no improvement in 4-year bPFS compared with the 66 Gy regimen.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': ""Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing, People's Republic of China.""}, {'ForeName': 'Hong-Zhen', 'Initials': 'HZ', 'LastName': 'Li', 'Affiliation': ""Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing, People's Republic of China.""}, {'ForeName': 'Xian-Shu', 'Initials': 'XS', 'LastName': 'Gao', 'Affiliation': ""Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing, People's Republic of China. Electronic address: doctorgaoxs@126.com.""}, {'ForeName': 'Shang-Bin', 'Initials': 'SB', 'LastName': 'Qin', 'Affiliation': ""Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing, People's Republic of China.""}, {'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Li', 'Affiliation': ""Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing, People's Republic of China.""}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': ""Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing, People's Republic of China.""}, {'ForeName': 'Ming-Wei', 'Initials': 'MW', 'LastName': 'Ma', 'Affiliation': ""Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': ""Department of Radiation Oncology, Peking University First Hospital, Peking University, Beijing, People's Republic of China.""}, {'ForeName': 'Xue-Ying', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': ""Department of Medical Statistics, Peking University First Hospital, Peking University, Beijing, People's Republic of China.""}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Rush University Medical Center, Chicago, Illinois. Electronic address: dian_wang@rush.edu.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2019.09.047']
244,32268942,"Comparison of the Ultrathin Strut, Biodegradable Polymer Sirolimus-eluting Stent With a Durable Polymer Everolimus-eluting Stent in a Chinese Population: The Randomized BIOFLOW VI Trial.","PURPOSE


The BIOFLOW-VI (Biotronik-Safety and Clinical Performance of the Drug Eluting Orsiro Stent in the Treatment of Subjects With De Novo Coronary Artery Lesions-VI) study evaluates the angiographic efficacy, clinical safety, and effectiveness of the ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES) compared with a durable polymer everolimus-eluting stent (DP-EES). This randomized controlled clinical trial was designed to enable approval of new drug-eluting stents in China.
METHODS


A total of 440 eligible patients from 11 sites with up to 2 de novo native coronary artery lesions were randomly assigned to receive either BP-SES (n = 220) or DP-EES (n = 220) from July 2014 to September 2016 in this prospective, multicenter, noninferiority trial.
FINDINGS


The primary end point of 9-month in-stent late lumen loss (LLL) was 0.05 (0.02) mm in the BP-SES group versus 0.07 (0.02) mm in the DP-EES group, with a mean difference of -0.02 mm (95% CI, -0.06 to 0.03; P = 0.44; P noninferiority  < 0.0001). At 1 year, the target lesion failure rate (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) was similar between the 2 groups (BP-SES 2.3% vs DP-EES 1.4%; P = 0.50). No definite or probable stent thrombosis had occurred in any of the 2 treatment arms.
IMPLICATIONS


The randomized BIOFLOW-VI trial showed that BP-SES was noninferior to DP-EES with regard to the primary end point of 9-month in-stent LLL in a Chinese population. ClinicalTrials.gov Identifier: NCT02870985.",2020,"At 1 year, the target lesion failure rate (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) was similar between the 2 groups (BP-SES 2.3% vs DP-EES 1.4%; P = 0.50).","['440 eligible patients from 11 sites with up to 2 de novo native coronary artery lesions', 'Chinese Population', 'Subjects']","['Ultrathin Strut, Biodegradable Polymer Sirolimus-eluting Stent With a Durable Polymer Everolimus-eluting Stent', 'durable polymer everolimus-eluting stent (DP-EES', 'BP-SES', 'DP-EES', 'ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES']","['probable stent thrombosis', 'target lesion failure rate (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization', '9-month in-stent late lumen loss (LLL']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1261077', 'cui_str': 'Structure of lower lobe of left lung'}]",440.0,0.165546,"At 1 year, the target lesion failure rate (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) was similar between the 2 groups (BP-SES 2.3% vs DP-EES 1.4%; P = 0.50).","[{'ForeName': 'Chongjian', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Yuejin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China. Electronic address: yangyjfw@126.com.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Song', 'Affiliation': 'Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical therapeutics,['10.1016/j.clinthera.2020.02.014']
245,31474607,High-Flow Oxygen Therapy to Speed Weaning From Mechanical Ventilation: A Prospective Randomized Study.,"BACKGROUND


High-flow oxygen therapy has been widely adopted, but its use for weaning patients from mechanical ventilation has not been reported.
OBJECTIVE


To evaluate whether high-flow oxygen therapy improves the efficiency of weaning patients from mechanical ventilation.
METHODS


In a single-center, prospective study, patients receiving mechanical ventilation were randomly assigned to 1 of 3 groups (T-tube, pressure support ventilation, or high-flow oxygen) during 2-hour spontaneous breathing trials in a 14-day study. Participants were followed up until hospital discharge or death.
RESULTS


Of 268 patients included, 90 were assigned to the T-tube group, 96 to the pressure support ventilation group, and 82 to the high-flow oxygen group. The first-day 2-hour spontaneous breathing trial passing rates were higher in the pressure support ventilation and high-flow oxygen groups than in the T-tube group ( P  < .05). The time needed to pass the spontaneous breathing trial was less in the pressure support ventilation and high-flow oxygen groups than in the T-tube group ( P  < .05). The reintubation rate was lower and the successful weaning rate on the first day was higher in the high-flow oxygen group than in the T-tube and pressure support ventilation groups ( P  < .05). During the 14-day study period, the weaning time was less in the high-flow oxygen group than in the T-tube and pressure support ventilation groups ( P  < .05).
CONCLUSION


High-flow oxygen therapy can reduce the time needed to wean patients from mechanical ventilation by shortening the time needed to pass a spontaneous breathing trial and by decreasing the reintubation rate.",2019,The reintubation rate was lower and the successful weaning rate on the first day was higher in the high-flow oxygen group than in the T-tube and pressure support ventilation groups ( P  < .05).,"['patients receiving mechanical ventilation', '268 patients included', 'weaning patients from mechanical ventilation']","['pressure support ventilation group, and 82 to the high-flow oxygen group', '3 groups (T-tube, pressure support ventilation, or high-flow oxygen', 'High-Flow Oxygen Therapy to Speed', 'High-flow oxygen therapy', 'high-flow oxygen therapy', 'Weaning From Mechanical Ventilation']","['weaning time', 'time needed to pass the spontaneous breathing trial', 'reintubation rate', 'successful weaning rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}]","[{'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0175731', 'cui_str': 'T-tube, device (physical object)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",268.0,0.0301074,The reintubation rate was lower and the successful weaning rate on the first day was higher in the high-flow oxygen group than in the T-tube and pressure support ventilation groups ( P  < .05).,"[{'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Fen Liu, Zhenguo Zeng, Chengzhi Ding, and Ning Zhao are physicians, Rong Jiang is matron, and Kejian Qian is director, Department of Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yang Liu is docimaster in the Department of Bacteriology, Yong Li is a physician in the Department of Oncology, and Qin Liu is a physician in the Department of Respirology, First Affiliated Hospital of Nanchang University. Qiang Shao is a doctoral candidate at Nanchang University and a physician in the Department of Critical Care Medicine at First Affiliated Hospital of Nanchang University. Zhiyong Peng is director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Shao', 'Affiliation': 'Fen Liu, Zhenguo Zeng, Chengzhi Ding, and Ning Zhao are physicians, Rong Jiang is matron, and Kejian Qian is director, Department of Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yang Liu is docimaster in the Department of Bacteriology, Yong Li is a physician in the Department of Oncology, and Qin Liu is a physician in the Department of Respirology, First Affiliated Hospital of Nanchang University. Qiang Shao is a doctoral candidate at Nanchang University and a physician in the Department of Critical Care Medicine at First Affiliated Hospital of Nanchang University. Zhiyong Peng is director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Fen Liu, Zhenguo Zeng, Chengzhi Ding, and Ning Zhao are physicians, Rong Jiang is matron, and Kejian Qian is director, Department of Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yang Liu is docimaster in the Department of Bacteriology, Yong Li is a physician in the Department of Oncology, and Qin Liu is a physician in the Department of Respirology, First Affiliated Hospital of Nanchang University. Qiang Shao is a doctoral candidate at Nanchang University and a physician in the Department of Critical Care Medicine at First Affiliated Hospital of Nanchang University. Zhiyong Peng is director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhenguo', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': 'Fen Liu, Zhenguo Zeng, Chengzhi Ding, and Ning Zhao are physicians, Rong Jiang is matron, and Kejian Qian is director, Department of Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yang Liu is docimaster in the Department of Bacteriology, Yong Li is a physician in the Department of Oncology, and Qin Liu is a physician in the Department of Respirology, First Affiliated Hospital of Nanchang University. Qiang Shao is a doctoral candidate at Nanchang University and a physician in the Department of Critical Care Medicine at First Affiliated Hospital of Nanchang University. Zhiyong Peng is director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Fen Liu, Zhenguo Zeng, Chengzhi Ding, and Ning Zhao are physicians, Rong Jiang is matron, and Kejian Qian is director, Department of Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yang Liu is docimaster in the Department of Bacteriology, Yong Li is a physician in the Department of Oncology, and Qin Liu is a physician in the Department of Respirology, First Affiliated Hospital of Nanchang University. Qiang Shao is a doctoral candidate at Nanchang University and a physician in the Department of Critical Care Medicine at First Affiliated Hospital of Nanchang University. Zhiyong Peng is director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Fen Liu, Zhenguo Zeng, Chengzhi Ding, and Ning Zhao are physicians, Rong Jiang is matron, and Kejian Qian is director, Department of Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yang Liu is docimaster in the Department of Bacteriology, Yong Li is a physician in the Department of Oncology, and Qin Liu is a physician in the Department of Respirology, First Affiliated Hospital of Nanchang University. Qiang Shao is a doctoral candidate at Nanchang University and a physician in the Department of Critical Care Medicine at First Affiliated Hospital of Nanchang University. Zhiyong Peng is director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Fen Liu, Zhenguo Zeng, Chengzhi Ding, and Ning Zhao are physicians, Rong Jiang is matron, and Kejian Qian is director, Department of Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yang Liu is docimaster in the Department of Bacteriology, Yong Li is a physician in the Department of Oncology, and Qin Liu is a physician in the Department of Respirology, First Affiliated Hospital of Nanchang University. Qiang Shao is a doctoral candidate at Nanchang University and a physician in the Department of Critical Care Medicine at First Affiliated Hospital of Nanchang University. Zhiyong Peng is director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Fen Liu, Zhenguo Zeng, Chengzhi Ding, and Ning Zhao are physicians, Rong Jiang is matron, and Kejian Qian is director, Department of Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yang Liu is docimaster in the Department of Bacteriology, Yong Li is a physician in the Department of Oncology, and Qin Liu is a physician in the Department of Respirology, First Affiliated Hospital of Nanchang University. Qiang Shao is a doctoral candidate at Nanchang University and a physician in the Department of Critical Care Medicine at First Affiliated Hospital of Nanchang University. Zhiyong Peng is director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Fen Liu, Zhenguo Zeng, Chengzhi Ding, and Ning Zhao are physicians, Rong Jiang is matron, and Kejian Qian is director, Department of Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yang Liu is docimaster in the Department of Bacteriology, Yong Li is a physician in the Department of Oncology, and Qin Liu is a physician in the Department of Respirology, First Affiliated Hospital of Nanchang University. Qiang Shao is a doctoral candidate at Nanchang University and a physician in the Department of Critical Care Medicine at First Affiliated Hospital of Nanchang University. Zhiyong Peng is director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Fen Liu, Zhenguo Zeng, Chengzhi Ding, and Ning Zhao are physicians, Rong Jiang is matron, and Kejian Qian is director, Department of Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yang Liu is docimaster in the Department of Bacteriology, Yong Li is a physician in the Department of Oncology, and Qin Liu is a physician in the Department of Respirology, First Affiliated Hospital of Nanchang University. Qiang Shao is a doctoral candidate at Nanchang University and a physician in the Department of Critical Care Medicine at First Affiliated Hospital of Nanchang University. Zhiyong Peng is director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Kejian', 'Initials': 'K', 'LastName': 'Qian', 'Affiliation': 'Fen Liu, Zhenguo Zeng, Chengzhi Ding, and Ning Zhao are physicians, Rong Jiang is matron, and Kejian Qian is director, Department of Critical Care Medicine, First Affiliated Hospital of Nanchang University, Nanchang, China. Yang Liu is docimaster in the Department of Bacteriology, Yong Li is a physician in the Department of Oncology, and Qin Liu is a physician in the Department of Respirology, First Affiliated Hospital of Nanchang University. Qiang Shao is a doctoral candidate at Nanchang University and a physician in the Department of Critical Care Medicine at First Affiliated Hospital of Nanchang University. Zhiyong Peng is director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China. ndyfyicu@email.ncu.edu.cn.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2019130']
246,31494807,Pain during and after-hernioplasty in raquidian or locorregional anesthesia by locking peripheral nerves.,"PURPOSE


To analyze pain scores after surgery in a group of patients submitted to inguinal hernia repair under peripheral nerve block with local or spinal anesthesia.
METHODS


Fifty patients were divided into two groups (both with 25 patients each). In the first group the patients were submitted to herniorrhaphy under peripheral block and local anesthesia (LG) and in the other group the patients were submitted to the same procedure under spinal anesthesia (RG). The pain was assessed using the international visual analog pain scale at four different moments. The analysis cost of the procedure was performed using the hospital's average final cost, without including medical expenses.
RESULTS


The groups were homogeneous in relation to the epidemiological and clinical features. There was no significant difference between the pain in the intraoperative period and in the return visit for both groups (p = 0.17 and p = 0.18). In the immediate postoperative period, both groups reported no pain at all. In general, the RG reported a greater pain score (16% for RG and 12% for LG). Complications were more frequent in patients submitted to spinal anesthesia (40% versus 8%) (p = 0.008). The surgical time was higher in the LG (39.3 ± 9.2 min) versus (28.7 ± 7.5 min) (p = 0.01). The average final cost of the procedure was US$ 100.98 for the LG and US$ 166.19 for the RG (p = 0.00).
CONCLUSION


The inguinal hernioplastia under local anesthesia plus sedation is a safe method, with a low incidence of complications, great acceptance by patients and less expensive.",2019,Complications were more frequent in patients submitted to spinal anesthesia (40% versus 8%) (p = 0.008).,['Fifty patients were divided into two groups (both with 25 patients each'],"['herniorrhaphy under peripheral block and local anesthesia (LG', 'inguinal hernia repair under peripheral nerve block with local or spinal anesthesia', 'hernioplasty in raquidian or locorregional anesthesia', 'same procedure under spinal anesthesia (RG']","['pain scores', 'pain score', 'pain', 'surgical time', 'average final cost of the procedure', 'Complications', 'Pain', 'international visual analog pain scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia (procedure)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0042815', 'cui_str': 'Visual Analog Pain Scale'}]",50.0,0.0215801,Complications were more frequent in patients submitted to spinal anesthesia (40% versus 8%) (p = 0.008).,"[{'ForeName': 'P M F', 'Initials': 'PMF', 'LastName': 'de Souza', 'Affiliation': ', Belo Horizonte city, Brazil. psanchescarneiro@gmail.com.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Ferreira', 'Affiliation': 'Madre Teresa Hospital, Belo Horizonte, Brazil.'}, {'ForeName': 'L F S', 'Initials': 'LFS', 'LastName': 'Marinari', 'Affiliation': 'UFJF, Juiz de Fora, Brazil.'}, {'ForeName': 'J C M', 'Initials': 'JCM', 'LastName': 'Brandão', 'Affiliation': 'Harvard Medical School, Boston, USA.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Carneiro', 'Affiliation': 'UNMDP, Mar del Plata, Argentina.'}, {'ForeName': 'D P C', 'Initials': 'DPC', 'LastName': 'Garcia', 'Affiliation': 'FCMMG, Belo Horizonte, Brazil.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Petroianu', 'Affiliation': 'School of Medicine, UFMG, Belo Horizonte, Brazil.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Alberti', 'Affiliation': 'School of Medicine, UFMG, Belo Horizonte, Brazil.'}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-019-02039-y']
247,31662165,"Promoting Cooking, Nutrition, and Physical Activity in Afterschool Settings.","Objective:  In this study, we evaluated the afterschool PAWS (Peer-education About Weight Steadiness) Club program delivered by peer or adult educators to improve food choices, physical activity, and psychosocial variables related to healthy eating.  Methods:  We had 109 adolescents (53 in adult-led group; 56 in peer-led group) participate in a cluster randomized controlled intervention. The 12-session curriculum framed within Social Cognitive Theory (SCT) and Stages of Change addressed mediators of behavior change related to cooking skills, food intake, and physical activity. Anthropometric, dietary intake, physical activity, and SCT mediators were assessed at baseline, post-intervention, and 6-months post-intervention.  Results:  Adolescents in the peer-led group significantly improved whole grain intake at post-intervention (p = .017) and 6-months post-intervention (p = .014). Both peer-led and adult-led groups had significant reductions in caloric intake at 6-months post-intervention (p = .047). Only the adult-led group improved self-efficacy (SE) and social/family support (SS) for healthy eating at post-intervention [p = .019 (SE); p = .048 (SS)] and 6-months post-intervention [p = .036 (SE); p = .022 (SS)].  Conclusions:  The PAWS Club program promoted lower caloric intake by adolescents. Peer educators were effective at increasing whole grains in adolescents, and adult educators contributed to positive changes in SE and SS related to healthy eating.",2019,Both peer-led and adult-led groups had significant reductions in caloric intake at 6-months post-intervention (p = .047).,['109 adolescents (53 in adult-led group; 56 in peer-led group) participate in a cluster randomized controlled intervention'],"['Club program delivered by peer or adult educators to improve food choices, physical activity']","['Anthropometric, dietary intake, physical activity, and SCT mediators', 'caloric intake', 'self-efficacy (SE) and social/family support (SS) for healthy eating', 'whole grain intake', 'afterschool PAWS (Peer-education About Weight Steadiness']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0150232', 'cui_str': 'Family support (regime/therapy)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",109.0,0.0358016,Both peer-led and adult-led groups had significant reductions in caloric intake at 6-months post-intervention (p = .047).,"[{'ForeName': 'Henna', 'Initials': 'H', 'LastName': 'Muzaffar', 'Affiliation': 'Henna Muzaffar, Assistant Professor and EDOC Facilitator, School of Health Studies, College of Health and Human Sciences, Northern Illinois University, DeKalb, IL;, Email: hmuzaffar@niu.edu.'}, {'ForeName': 'Cassandra J', 'Initials': 'CJ', 'LastName': 'Nikolaus', 'Affiliation': 'Cassandra Nikolaus, Postdoctoral Research Associate, Institute of Research and Education to Advance Community Health, Seattle, WA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Ogolsky', 'Affiliation': 'Brian G. Ogolsky, Associate Professor and Director of Graduate Programs, Department of Human Development and Family Studies, University of Illinois at Urbana-Champaign, Urbana, IL.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'Amanda Lane, UF Health Shands Dialysis Center, Gainesville, FL.'}, {'ForeName': 'Carli', 'Initials': 'C', 'LastName': 'Liguori', 'Affiliation': 'Carli Liguori, Visiting Instructor, Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Nickols-Richardson', 'Affiliation': 'Sharon M. Nickols-Richardson, Associate Dean and Director of Extension and Outreach and Professor of Food Science and Human Nutrition, College of Agricultural, Consumer and Environmental Sciences, University of Illinois at Urbana-Champaign, Urbana, IL.'}]",American journal of health behavior,['10.5993/AJHB.43.6.4']
248,32253054,"Relative Bioavailability of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Administered With and Without a Spacer: Results of a Phase I, Randomized, Crossover Trial in Healthy Adults.","PURPOSE


The triple combination therapy budesonide/glycopyrrolate/formoterol fumarate in a metered dose inhaler (BGF MDI), formulated by using innovative co-suspension delivery technology, is a new inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β 2 -agonist fixed-dose combination for the maintenance treatment of COPD. For some patients, the use of an MDI may be optimized with a spacer. This Phase I study assessed the effect of a spacer on lung exposure, total systemic exposure, and safety of BGF MDI 320/36/9.6 μg in healthy subjects.
METHODS


This randomized, open-label, crossover study assessed the pharmacokinetic and safety profiles of BGF MDI in healthy adult subjects who received a single dose of BGF MDI 320/36/9.6 μg (administered as 2 inhalations with 160/18/4.8 μg per actuation) in 4 regimens: without spacer and no charcoal; with spacer and no charcoal; without spacer and with charcoal; and with spacer and with charcoal. Primary objectives were to assess total systemic exposure (without charcoal) and lung exposure (with charcoal) of budesonide, glycopyrronium, and formoterol administered as BGF MDI with and without a spacer. Safety was also assessed.
FINDINGS


In total, 56 subjects were randomized (mean age, 29.9 years; 60.7% male, 17.9% former smokers). For systemic exposure (without charcoal), the spacer/without spacer ratio, expressed as a percentage (intrasubject %CV) of C max  and AUC 0-tlast , respectively, was 152.0 (47.5) and 132.8 (43.6) for budesonide, 240.6 (80.2) and 154.7 (73.4) for glycopyrronium, and 165.6 (50.7) and 98.6 (53.8) for formoterol. For lung exposure (with charcoal), the spacer/without spacer ratio percentage (%CV) of C max  and AUC 0-tlast , respectively, was 183.6 (65.9) and 198.4 (71.5) for budesonide, 262.0 (91.8) and 373.9 (120.7) for glycopyrronium, and 222.9 (56.3) and 385.2 (147.0) for formoterol. Subjects who were judged to have suboptimal inhalation technique without a spacer (those in the lowest drug exposure quartile based on AUC 0-tlast ) had the greatest increase in both total systemic and lung exposure when a spacer was used versus no spacer. Subjects in the highest quartile had a minimal change in both total systemic and lung exposure when the spacer was used. Treatment-emergent adverse events (TEAEs) (all mild/moderate) reported by >1 subject per regimen were headache, cough, and dizziness. One subject withdrew because of TEAEs of headache and presyncope (neither considered treatment-related).
IMPLICATIONS


Drug delivery can be improved for subjects with suboptimal MDI inhalation technique when using a spacer device with BGF MDI triple therapy. ClinicalTrials.gov identifier: NCT03311373.",2020,Subjects in the highest quartile had a minimal change in both total systemic and lung exposure when the spacer was used.,"['healthy subjects', '56 subjects were randomized (mean age, 29.9 years', 'subjects with suboptimal MDI inhalation technique', 'Subjects who were judged to have suboptimal inhalation technique without a spacer (those in the lowest drug exposure quartile based on AUC 0-tlast ', 'healthy adult subjects who received a single dose of', 'Healthy Adults']","['budesonide', 'Budesonide/Glycopyrrolate/Formoterol Fumarate', 'BGF MDI 320/36/9.6\xa0μg (administered as 2 inhalations with 160/18/4.8\xa0μg per actuation) in 4 regimens: without spacer and no charcoal; with spacer and no charcoal; without spacer and with charcoal; and with spacer and with charcoal', 'BGF MDI triple therapy', 'budesonide/glycopyrrolate/formoterol fumarate', 'BGF MDI']","['lung exposure, total systemic exposure, and safety', 'total systemic exposure (without charcoal) and lung exposure (with charcoal) of budesonide, glycopyrronium, and formoterol administered as BGF MDI with and without a spacer', 'total systemic and lung exposure', 'Safety', 'headache, cough, and dizziness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0104281', 'cui_str': 'AS 2'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C4319628', 'cui_str': 'Actuation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",56.0,0.050227,Subjects in the highest quartile had a minimal change in both total systemic and lung exposure when the spacer was used.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, Durham, NC, USA. Electronic address: paul.dorinsky1@astrazeneca.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'DePetrillo', 'Affiliation': 'Pharmaron, Baltimore, MD, USA.'}, {'ForeName': 'Kiernan', 'Initials': 'K', 'LastName': 'DeAngelis', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'AstraZeneca, Durham, NC, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Darken', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gillen', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.02.012']
249,32265363,High-flow Nasal Oxygen Versus Standard Oxygen During Flexible Bronchoscopy in Lung Transplant Patients: A Randomized Controlled Trial.,"BACKGROUND


Diagnostic and interventional flexible bronchoscopy (FB) is increasingly utilized in complex and high-risk patients. Patients are often sedated for comfort and procedure facilitation and hypoxia is commonly observed in this setting. We hypothesized that high-flow nasal oxygen (HFNO) would reduce the incidence of patients experiencing oxygen desaturation.
METHODS


In this randomized controlled trial, postlung transplant patients booked for FB with transbronchial lung biopsy were assigned to either HFNO or low-flow nasal oxygen (LFNO). The patient and bronchoscopist were blinded to group allocation. The primary endpoint was the proportion of patients experiencing mild desaturation [peripheral oxygen saturation (SpO2)<94%]. Secondary endpoints included desaturation (SpO2<90%), the number of airway interventions required and procedure interruptions, the duration of oxygen desaturation and patient, bronchoscopist and anesthesiologist satisfaction scores.
RESULTS


The trial analyzed data from 76 patients (LFNO, n=39; HFNO, n=37). HFNO reduced the proportion of patients experiencing SpO2<94% (43.2% vs. 89.7%, P<0.001) and SpO2<90% (16.2% vs. 69.2%, P<0.001). The FB was interrupted 11 times in 9 patients in the LFNO group, whereas there were no interruptions in the HFNO group. There were no differences in patient and bronchoscopist satisfaction scores between groups, anesthesiologists had higher satisfaction scores when using HFNO (P<0.001).
CONCLUSION


Hypoxia occurred less commonly in postlung transplant patients receiving HFNO during FB. Further studies are warranted in other high-risk populations undergoing longer duration FB.",2020,"There were no differences in patient and bronchoscopist satisfaction scores between groups, anesthesiologists had higher satisfaction scores when using HFNO (P<0.001).
","['76 patients (LFNO, n=39; HFNO, n=37', 'postlung transplant patients booked for FB with transbronchial lung biopsy', 'Lung Transplant Patients']","['Flexible Bronchoscopy', 'high-flow nasal oxygen (HFNO', 'interventional flexible bronchoscopy (FB', 'HFNO', 'HFNO or low-flow nasal oxygen (LFNO', 'High-flow Nasal Oxygen Versus Standard Oxygen']","['satisfaction scores', 'proportion of patients experiencing mild desaturation [peripheral oxygen saturation', 'patient and bronchoscopist satisfaction scores', 'desaturation (SpO2<90%), the number of airway interventions required and procedure interruptions, the duration of oxygen desaturation and patient, bronchoscopist and anesthesiologist satisfaction scores', 'FB']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0863477', 'cui_str': 'Transbronchial lung biopsy'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]",76.0,0.219131,"There were no differences in patient and bronchoscopist satisfaction scores between groups, anesthesiologists had higher satisfaction scores when using HFNO (P<0.001).
","[{'ForeName': 'Erez', 'Initials': 'E', 'LastName': 'Ben-Menachem', 'Affiliation': 'Department of Anaesthesia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McKenzie', 'Affiliation': 'Department of Anaesthesia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': ""O'Sullivan"", 'Affiliation': 'Department of Anaesthesia.'}, {'ForeName': 'Adrian P', 'Initials': 'AP', 'LastName': 'Havryk', 'Affiliation': 'Faculty of Medicine, University of New South Wales, NSW, Australia.'}]",Journal of bronchology & interventional pulmonology,['10.1097/LBR.0000000000000670']
250,32265500,Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study.,"Early molecular response is associated with improved probability of deep molecular response and superior survival in patients with CML-CP. However, ~1 in 3 patients on first-line imatinib do not achieve this threshold. The phase 2b DASCERN trial (NCT01593254) assessed the outcome of early switch to dasatinib in patients with suboptimal response to first-line imatinib. Adult patients with CML-CP were randomized (2:1) to receive 100 mg dasatinib (n = 174) or continue imatinib at ≥400 mg (n = 86). The primary endpoint was the rate of major molecular response (MMR) at 12 months, which was 29% (dasatinib) and 13% (imatinib; P = 0.005). After ≥2 years of follow-up, 45 patients (52%) randomized to continue imatinib had crossed over to dasatinib. Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat). Adverse events were consistent with the established safety profiles of both drugs. The results of this first prospective study support early monitoring of patients treated with first-line imatinib, and suggest that switching to dasatinib in cases of suboptimal response may offer clinical benefit. Further follow-up is needed to assess the long-term clinical benefit of early switching.",2020,"Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat).","['patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy', 'patients with CML-CP', 'Adult patients with CML-CP', 'patients with suboptimal response to first-line imatinib']","['Dasatinib vs. imatinib', '100\u2009mg dasatinib (n\u2009=\u2009174) or continue imatinib']","['probability of deep molecular response and superior survival', '2-year cumulative MMR rate', 'Adverse events', 'rate of major molecular response (MMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0336482,"Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat).","[{'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta University, Augusta, GA, USA. jorge.cortes@augusta.edu.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Jianyu', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': ""Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Huanling', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': 'Universitätsklinikum Jena, Jena, Germany.'}, {'ForeName': 'Dong-Wook', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jerald', 'Initials': 'J', 'LastName': 'Radich', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Savona', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martin-Regueira', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Oumar', 'Initials': 'O', 'LastName': 'Sy', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Gurnani', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Saglio', 'Affiliation': 'University of Turin, Turin, Italy.'}]",Leukemia,['10.1038/s41375-020-0805-1']
251,32143828,Effect of a Schlemm's Canal Microstent on Early Postoperative Intraocular Pressure after Cataract Surgery: An Analysis of the HORIZON Randomized Controlled Trial.,"PURPOSE


To compare early postoperative intraocular pressure (IOP) in patients who underwent cataract surgery alone with those who underwent cataract surgery combined with implantation of a Hydrus Microstent (HMS) (Ivantis, Irvine, CA).
DESIGN


Subanalysis of data from the randomized controlled HORIZON trial, a multicenter trial including 26 US and 12 international sites.
PARTICIPANTS


Participants with mild/moderate primary open-angle glaucoma (POAG) and visually significant cataract with mean modified diurnal IOP between 22 and 34 mmHg after washout of IOP-lowering medications.
METHODS


A total of 556 subjects were randomized in a 2:1 ratio to undergo cataract surgery with placement of the HMS versus cataract surgery alone (no microstent [NMS]). All eyes were washed out of IOP-lowering medications before surgery and remained unmedicated until surgery. No IOP-lowering prophylaxis was used postoperatively. Comprehensive eye examination including measurement of intraocular pressure was conducted on postoperative day (POD) 1, week 1, and month 1.
MAIN OUTCOME MEASURES


Postoperative IOP >40 mmHg was analyzed as the primary outcome. Incidence of IOP increase >10 mmHg above baseline, unmedicated IOP, and mean IOP were analyzed as secondary outcomes.
RESULTS


A total of 369 eyes were randomized to the HMS group, and 187 eyes were randomized to cataract surgery alone. The HMS and NMS groups did not differ with respect to baseline demographic or ocular characteristics. On POD1, the incidence of IOP spike >40 mmHg was significantly higher at 14.4% in the NMS group compared with 1.4% in the HMS group (P < 0.001). The incidence of IOP increase ≥10 mmHg relative to baseline on POD1 was also significantly higher in the NMS group than in the HMS group (22.5% vs. 3.0%, P < 0.001). IOP in the NMS group was significantly higher than in the HMS group (27.6 vs. 17.0 mmHg, P < 0.001). In multivariable logistic regression analysis, higher baseline IOP predicted higher odds of POD1 IOP spike >40 mmHg, whereas the presence of HMS was associated with a lower likelihood of postoperative IOP spike.
CONCLUSIONS


The addition of an HMS at the time of cataract surgery lowered the risk of markedly elevated IOP in the early postoperative period in patients with glaucoma.",2020,"The incidence of IOP increase ≥10 mmHg relative to baseline on POD1 was also significantly higher in the NMS group than in the HMS group (22.5% vs. 3.0%, P < 0.001).","['patients who underwent cataract surgery alone with those who underwent', 'Participants with mild/moderate primary open-angle glaucoma (POAG) and visually significant cataract with mean modified diurnal IOP between 22 and 34 mmHg after washout of IOP-lowering medications', 'after Cataract Surgery', 'A total of 556 subjects', '26 US and 12 international sites', 'A total of 369 eyes were randomized to the HMS group, and 187 eyes', 'patients with glaucoma']","['cataract surgery alone (no microstent [NMS', 'cataract surgery with placement of the HMS', ""Schlemm's Canal Microstent"", 'NMS', 'HMS', 'cataract surgery alone', 'cataract surgery combined with implantation of a Hydrus Microstent (HMS) (Ivantis, Irvine, CA']","['Incidence of IOP increase >10 mmHg above baseline, unmedicated IOP, and mean IOP', 'early postoperative intraocular pressure (IOP', 'Early Postoperative Intraocular Pressure', 'IOP spike >40 mmHg', 'Postoperative IOP', 'incidence of IOP increase ≥10 mmHg relative to baseline on POD1', 'IOP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1306068', 'cui_str': 'Secondary Cataract'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}]","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0229108', 'cui_str': 'Structure of sinus venosus of sclera'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure (finding)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]",556.0,0.295207,"The incidence of IOP increase ≥10 mmHg relative to baseline on POD1 was also significantly higher in the NMS group than in the HMS group (22.5% vs. 3.0%, P < 0.001).","[{'ForeName': 'Nazlee', 'Initials': 'N', 'LastName': 'Zebardast', 'Affiliation': 'Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Chengjie', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Henry D', 'Initials': 'HD', 'LastName': 'Jampel', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland. Electronic address: hjampel@jhmi.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2020.01.025']
252,31505367,Blame-rebalance fMRI neurofeedback in major depressive disorder: A randomised proof-of-concept trial.,"Previously, using fMRI, we demonstrated lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions while patients with major depressive disorder (MDD) experience guilt. This neural signature was detected despite symptomatic remission which suggested a putative role in vulnerability. This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature. To this end, we developed a fMRI neurofeedback software (FRIEND), which measures ATL-SCC coupling and displays its levels in real time. Twenty-eight patients with remitted MDD were randomised to two groups, each receiving one session of fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories. They were instructed to feel the emotion whilst trying to increase the level of a thermometer-like display on a screen. Active intervention group: The thermometer levels increased with increasing levels of ATL-SCC correlations in the guilt condition. Control intervention group: The thermometer levels decreased when correlation levels deviated from the previous baseline level in the guilt condition, thus reinforcing stable correlations. Both groups also received feedback during the indignation condition reinforcing stable correlations. We confirmed our predictions that patients in the active intervention group were indeed able to increase levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem after training compared to before training and that this differed significantly from the control intervention group. These data provide proof-of-concept for a novel treatment target for MDD patients and are in keeping with the hypothesis that ATL-SCC connectivity plays a key role in self-worth. https://clinicaltrials.gov/ct2/show/results/NCT01920490.",2019,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"['patients with major depressive disorder (MDD) experience guilt', 'major depressive disorder', 'patients with MDD', 'Twenty-eight patients with remitted MDD']","['fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories', 'Control intervention']","['levels of ATL-SCC correlations', 'lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions', 'levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441997', 'cui_str': 'Right anterior (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",28.0,0.0826356,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Weingartner', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Basilio', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bado', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas (ICB), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Mattos', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'João R', 'Initials': 'JR', 'LastName': 'Sato', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Center for Mathematics, Computation, and Cognition, Universidade Federal do ABC, Santo André, Brazil.""}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'de Oliveira-Souza', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Gaffrée e Guinle University Hospital, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Fontenelle', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moll', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Scients Institute, Palo Alto, USA. Electronic address: jorge.moll@idor.org.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101992']
253,32265061,"A Phase I Study on the Pharmacokinetics and Pharmacodynamics of DJT1116PG, a Novel Selective Inhibitor of Sodium-glucose Cotransporter Type 2, in Healthy Individuals at Steady State.","PURPOSE


DJT1116PG, which selectively inhibits renal glucose reabsorption by inhibiting sodium-glucose cotransporter type 2, was developed as an insulin-independent treatment for type 2 diabetes mellitus. This Phase I trial evaluated the pharmacokinetic and pharmacodynamic properties of DJT1116PG at steady state in healthy Chinese individuals.
METHODS


This was a multiple ascending dose study of DJT1116PG (20, 50, and 100 mg once daily for 7 days) that included 36 healthy individuals.
FINDINGS


There were no serious adverse events or deaths in these studies, and no adverse event led to study discontinuation. Oral DJT1116PG was rapidly absorbed with a T max  of 0.75-1.5 h and a t ½  of 12-16.2 h. Systemic exposure (C max  and AUC) of DJT1116PG and its inactive metabolites (T1444, T1454, and T1830) increased in a dose-dependent manner. Urinary glucose excretion (UGE) plateaued at 50 mg of DJT1116PG in a previous single ascending dose study and on day 1 of this study. UGE plateaued at 20 mg of DJT1116PG on day 7 of this study. Serum glucose parameters were similar in individuals who received DJT1116PG or placebo.
IMPLICATIONS


DJT1116PG was well tolerated in healthy Chinese individuals. At steady state, UGE plateaued at 20 mg of DJT1116PG in these individuals. These findings will inform the selection of doses for further early-stage clinical trials of DJT1116PG. Chinese Drug Trial Identifier: CTR20160986.",2020,"Oral DJT1116PG was rapidly absorbed with a T max  of 0.75-1.5 h and a t ½  of 12-16.2 h. Systemic exposure (C max  and AUC) of DJT1116PG and its inactive metabolites (T1444, T1454, and T1830) increased in a dose-dependent manner.","['Healthy Individuals at Steady State', 'type 2 diabetes mellitus', 'healthy Chinese individuals', '36 healthy individuals']","['Oral DJT1116PG', 'DJT1116PG or placebo', 'DJT1116PG']","['Urinary glucose excretion (UGE', 'Serum glucose parameters']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",36.0,0.0531884,"Oral DJT1116PG was rapidly absorbed with a T max  of 0.75-1.5 h and a t ½  of 12-16.2 h. Systemic exposure (C max  and AUC) of DJT1116PG and its inactive metabolites (T1444, T1454, and T1830) increased in a dose-dependent manner.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Jingrui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China. Electronic address: wumin1987mary@126.com.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China. Electronic address: yanhuad2019@163.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.03.007']
254,31297739,One more option in heart failure: correction of mitral regurgitation with MitraClip ® .,"Degenerative mitral regurgitation in elderly patients and functional mitral regurgitation secondary to severe left ventricular dysfunction are not easy options for conventional surgery. Recently, a new percutaneous approach has been proposed with the MitraClip ® , based on the Alfieri edge-to-edge repair technique. The aim of the study is to report, compare and discuss the results of two multicenter randomized trials: MITRA.FR and COAPT in light of the current practice. In both trials patients with functional mitral regurgitation grade 3/4+ or 4/4+ were randomly assigned, in 1:1 ratio, to undergo percutaneous repair and optimal medical therapy or optimal medical therapy alone. Other baseline characteristics reflecting severity of mitral regurgitation and of left ventricular impairment were statistically different, such as the effective regurgitant orifice area (0.31 cm 2  in MITRA.FR vs 0.41 cm 2  in COAPT) and the indexed LVEDV (135 ± 37 ml/m 2  in MITRA.FR vs 101 ± 34 ml/m 2  in COAPT). A 24 months follow-up and a 12 months follow-up have been completed, respectively, in COAPT and MITRA.FR. Out of the 307 patients enrolled in the MITRA.FR, 152 were randomized to percutaneous treatment but only in 138 (95.8%) the MitraClip ®  was actually implanted. At the end of the follow-up a residual mitral regurgitation of at least grade 3+ has been observed in 17% of the patients. A composite of death from any cause or unplanned hospitalizations for heart failure at 12 months respectively occurred in 83 patients (54.6%) treated percutaneously and 78 patients (51.3%) treated with medical therapy only. A total of 614 patients have been enrolled in the COAPT and 293 underwent transcatheter treatment. A successful implantation of the MitraClip ®  was achieved in 287 patients (98.0%). Hospitalization for heart failure at 24 months occurred in 160 patients in the device group and in 283 in the control group, with an annualized ratio of 35.8% and 67.9%, respectively (p > 0.001). The conflicting results of the two trials may have many explanations, but probably the main cause is the most stringent inclusion criteria in COAPT. The effective reduction of mitral regurgitation and improvement in exercise capacity already observed in registries including more than 70,000 patients was confirmed in a randomized trial with improvement observed in hard end-points. This has already led to an extension of FDA approval to functional regurgitation and a more liberal use across the world.",2019,A composite of death from any cause or unplanned hospitalizations for heart failure at 12 months respectively occurred in 83 patients (54.6%) treated percutaneously and 78 patients (51.3%) treated with medical therapy only.,"['307 patients enrolled in the MITRA.FR, 152', '287 patients (98.0', 'trials patients with functional mitral regurgitation grade 3/4+ or 4/4', 'elderly patients and functional mitral regurgitation secondary to severe left ventricular dysfunction', '614 patients have been enrolled in the COAPT and 293 underwent transcatheter treatment']","['MITRA.FR and COAPT', 'MitraClip ® ', 'percutaneous repair and optimal medical therapy or optimal medical therapy alone', 'MitraClip ®  was actually implanted']","['heart failure', 'exercise capacity', 'residual mitral regurgitation', 'mitral regurgitation and of left ventricular impairment', 'Hospitalization for heart failure', 'Degenerative mitral regurgitation', 'effective regurgitant orifice area']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0242973', 'cui_str': 'Ventricular Dysfunction'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",614.0,0.0720015,A composite of death from any cause or unplanned hospitalizations for heart failure at 12 months respectively occurred in 83 patients (54.6%) treated percutaneously and 78 patients (51.3%) treated with medical therapy only.,"[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Bini', 'Affiliation': 'Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, University Hospital Careggi, Florence, Italy. tbini92@gmail.com.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Agostini', 'Affiliation': 'Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Miroslava', 'Initials': 'M', 'LastName': 'Stolcova', 'Affiliation': 'Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Meucci', 'Affiliation': 'Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Mario', 'Affiliation': 'Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, University Hospital Careggi, Florence, Italy.'}]",Internal and emergency medicine,['10.1007/s11739-019-02140-1']
255,31408838,APOE gene-dependent BOLD responses to a breath-hold across the adult lifespan.,"Age and apolipoprotein E (APOE) e4 genotype are two of the strongest known risk factors for sporadic Alzheimer's disease (AD). Neuroimaging has shown hemodynamic response changes with age, in asymptomatic carriers of the APOE e4 allele, and in AD. In this study, we aimed to characterize and differentiate age- and APOE gene-specific hemodynamic changes to breath-hold and visual stimulation. A further aim was to study whether these responses were modulated by 3-day intake of nitrate, a nitric oxide (NO) source. The study was designed as a randomized, double-blinded, placebo-controlled crossover study, and the study cohort comprised 41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70 years at enrollment. The participants underwent two scanning sessions, each preceded by ingestion of sodium nitrate or sodium chloride (control). During functional magnetic resonance imaging (fMRI) sessions, participants performed two concurrent tasks; a breath-hold task to probe cerebrovascular reactivity and a visual stimulation task to evoke functional hyperemia, respectively. We found that the blood oxygenation level dependent (BOLD) hemodynamic response to breath-hold was altered in APOE e4 carriers relative to non-carriers. Mid-aged (50-60 years of age) e4 carriers exhibited a significantly increased peak time relative to mid-aged e3 carriers, and peak time for younger (30-40 years of age) e4 carriers was significantly shorter than that of mid-aged e4 carriers. The response width was significantly increased for e4 carriers. The response peak magnitude significantly decreased with age. For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type. We found no effect of nitrate ingestion on BOLD responses evoked by the breath-hold and visual stimulation tasks. The APOE gene-dependent response to breath-hold may reflect NO-independent differences in vascular function.",2019,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.",['41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70\u202fyears at enrollment'],"['sodium nitrate or sodium chloride (control', 'placebo', 'functional magnetic resonance imaging (fMRI) sessions', 'nitrate ingestion']","['response peak magnitude', 'blood oxygenation level dependent (BOLD) hemodynamic response', 'peak time relative', 'response width', 'Age and apolipoprotein E (APOE']","[{'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0523511', 'cui_str': 'Apolipoproteins E measurement (procedure)'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}]",,0.218788,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rasmussen', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: pmr@cfin.au.dk.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Aamand', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christiansen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Torben E', 'Initials': 'TE', 'LastName': 'Lund', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101955']
256,31610409,Impact of circadian rhythmicity and sleep restriction on circulating endocannabinoid (eCB) N-arachidonoylethanolamine (anandamide).,"OBJECTIVE


The endocannabinoid (eCB) system is involved in diverse aspects of human physiology and behavior but little is known about the impact of circadian rhythmicity on the system. The two most studied endocannabinoids, AEA (ananamide) and 2-AG (2-arachidonoylglycerol), can be measured in peripheral blood however the functional relevance of peripheral eCB levels is not clear. Having previously detailed the 24-h profile of serum 2-AG, here we report the 24-h serum profile of AEA to determine if these two endocannabinoids vary in parallel across the biological day including a nocturnal 8.5-h sleep period. Further, we assessed and compared the effect of a physiological challenge, in the form of sleep restriction to 4.5-h, on these two profiles.
METHODS


In this randomized crossover study, we examined serum concentrations of AEA across a 24-h period in fourteen young adults. Congeners of AEA, the structural analogs oleoylethanolamide (OEA) and palmitoylethanolamide (PEA) were simultaneously assayed. Prior to 24-h blood sampling, each participant was exposed to two nights of normal (8.5 h) or restricted sleep (4.5 h). The two sleep conditions were separated by at least one month. In both sleep conditions, during the period of blood sampling, each individual ate the same high-carbohydrate meal at 0900, 1400, and 1900.
RESULTS


Mean 24-h concentrations of AEA were 0.697 ± 0.11 pmol/ml. A reproducible biphasic 24-h profile of AEA was observed with a first peak occurring during early sleep (0200) and a second peak in the mid-afternoon (1500) while a nadir was detected in the mid-morning (1000). The 24-h profiles for both OEA and PEA followed a similar pattern to that observed for AEA. AEA, OEA, and PEA levels were not affected by sleep restriction at any time of day, contrasting with the elevation of early afternoon levels previously observed for 2-AG.
CONCLUSIONS


The 24-h rhythm of AEA is markedly different from that of 2-AG, being of lesser amplitude and biphasic, rather than monophasic. These observations suggest distinct regulatory pathways of the two eCB and indicate that time of day needs to be carefully controlled in studies attempting to delineate their relative roles. Moreover, unlike 2-AG, AEA is not altered by sleep restriction, suggesting that physiological perturbations may affect AEA and 2-AG differently. Similar 24-h profiles were observed for OEA and PEA following normal and restricted sleep, further corroborating the validity of the wave-shape and lack of response to sleep loss observed for the AEA profile. Therapeutic approaches involving agonism or antagonism of peripheral eCB signaling will likely need to be tailored according to time of day.",2020,"AEA, OEA, and PEA levels were not affected by sleep restriction at any time of day, contrasting with the elevation of early afternoon levels previously observed for 2-AG.
",['fourteen young adults'],"['AEA', '2-AG (2-arachidonoylglycerol', 'circadian rhythmicity and sleep restriction on circulating endocannabinoid (eCB) N-arachidonoylethanolamine (anandamide']","['AEA, OEA, and PEA levels', 'Mean 24-h concentrations of AEA', 'OEA and PEA', '24-h rhythm of AEA']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0299477', 'cui_str': '5,8,11,14-Eicosatetraenoic acid, 2-hydroxy-1-(hydroxymethyl)ethyl ester, (5Z,8Z,11Z,14Z)-'}, {'cui': 'C0031084', 'cui_str': 'Rhythmicity'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoids'}, {'cui': 'C3180487', 'cui_str': 'N-arachidonoylethanolamine'}, {'cui': 'C0211726', 'cui_str': 'anandamide (20.4,n-6)'}]","[{'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0441317,"AEA, OEA, and PEA levels were not affected by sleep restriction at any time of day, contrasting with the elevation of early afternoon levels previously observed for 2-AG.
","[{'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Hanlon', 'Affiliation': 'University of Chicago, Department of Medicine, MC 1027, Section of Endocrinology, Diabetes, and Metabolism, 5841 S Maryland Ave, Chicago, IL 60637, United States. Electronic address: ehanlon@medicine.bsd.uchicago.edu.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.104471']
257,31630052,Intranasal oxytocin enhances EEG mu rhythm desynchronization during execution and observation of social action: An exploratory study.,"Intranasal administration of oxytocin (OT) has been found to facilitate prosocial behaviors, emotion recognition and cooperation between individuals. Recent electroencephalography (EEG) investigations have reported enhanced mu rhythm (alpha: 8-13 Hz; beta: 15-25 Hz) desynchronization during the observation of biological motion and stimuli probing social synchrony after the administration of intranasal OT. This hormone may therefore target a network of cortical circuits involved in higher cognitive functions, including the mirror neuron system (MNS). Here, in a double-blind, placebo-controlled, between-subjects exploratory study, we investigated whether intranasal OT modulates the cortical activity from sensorimotor areas during the observation and the execution of social and non-social grasping actions. Participants underwent EEG testing after receiving a single dose (24 IU) of either intranasal OT or placebo. Results revealed an enhancement of alpha - but not beta - desynchronization during observation and execution of social grasps, especially over central and parietal electrodes, in participants who received OT (OT group). No differences between the social and non-social condition were found in the control group (CTRL group). Moreover, we found a significant difference over the cortical central-parietal region between the OT and CTRL group only within the social condition. These results suggest a possible action of intranasal OT on sensorimotor circuits involved in social perception and action understanding, which might contribute to facilitate the prosocial effects typically reported by behavioral studies.",2020,"Intranasal administration of oxytocin (OT) has been found to facilitate prosocial behaviors, emotion recognition and cooperation between individuals.",[],"['oxytocin (OT', 'placebo', 'Intranasal oxytocin', 'intranasal OT', 'intranasal OT or placebo', 'OT and CTRL']","['cortical central-parietal region', 'social and non-social condition']",[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030560', 'cui_str': 'Parietal Cortex'}, {'cui': 'C0037403', 'cui_str': 'Social Conditions'}]",,0.0238602,"Intranasal administration of oxytocin (OT) has been found to facilitate prosocial behaviors, emotion recognition and cooperation between individuals.","[{'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Festante', 'Affiliation': 'Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, 56128, Pisa, Italy; Department of Medicine and Surgery, University of Parma, 43125, Parma, Italy.'}, {'ForeName': 'Pier Francesco', 'Initials': 'PF', 'LastName': 'Ferrari', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, 43125, Parma, Italy; Institut des Sciences Cognitives Marc Jeannerod, CNRS, Bron, Cedex 69675, France; Université Claude Bernard Lyon 1, Lyon, Cedex 69622, France.'}, {'ForeName': 'Samuel G', 'Initials': 'SG', 'LastName': 'Thorpe', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD 20740, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Buchanan', 'Affiliation': 'Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD 21228, USA.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD 20740, USA. Electronic address: fox@umd.edu.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.104467']
258,31670070,Evidence for decreased Neurologic Pain Signature activation following thoracic spinal manipulation in healthy volunteers and participants with neck pain.,"BACKGROUND CONTEXT


Spinal manipulation (SM) is a common treatment for neck and back pain, theorized to mechanically affect the spine leading to therapeutic mechanical changes. The link between specific mechanical effects and clinical improvement is not well supported. SM's therapeutic action may instead be partially mediated within the central nervous system.
PURPOSE


To introduce brain-based models of pain for spinal pain and manual therapy research, characterize the distributed central mechanisms of SM, and advance the preliminary validation of brain-based models as potential clinical biomarkers of pain.
STUDY DESIGN


Secondary analysis of two functional magnetic resonance imaging studies investigating the effect of thoracic SM on pain-related brain activity: A non-controlled, non-blinded study in healthy volunteers (Study 1, n = 10, 5 females, and mean age = 31.2 ± 10.0 years) and a randomized controlled study in participants with acute to subacute neck pain (Study 2, n = 24, 16 females, mean age = 38.0 ± 15.1 years).
METHODS


Functional magnetic resonance imaging was performed during noxious mechanical stimulation of the right index finger cuticle pre- and post-intervention. The effect of SM on pain-related activity was studied within brain regions defined by the Neurologic Pain Signature (NPS) that are predictive of physical pain.
RESULTS


In Study 1, evoked mechanical pain (p < 0.001) and NPS activation (p = 0.010) decreased following SM, and the changes in evoked pain and NPS activation were correlated (r RM 2  = 0.418, p = 0.016). Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019). In Study 2, neck pain (p = 0.046) and NPS (p = 0.033) activation decreased following verum but not sham SM. Associations between evoked pain, neck pain, and NPS activation, were not significant and less clear, possibly due to inadequate power, methodological limitations, or other confounding factors.
CONCLUSIONS


The findings provide preliminary evidence that SM may alter the processing of pain-related brain activity within specific pain-related brain regions and support the use of brain-based models as clinical biomarkers of pain.",2019,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","['healthy volunteers (Study 1, n\u202f=\u202f10, 5 females, and mean age\u202f=\u202f31.2\u202f±\u202f10.0 years', 'participants with acute to subacute neck pain (Study 2, n\u202f=\u202f24, 16 females, mean age\u202f=\u202f38.0\u202f±\u202f15.1 years', 'healthy volunteers and participants with neck pain']","['SM', 'thoracic SM', 'thoracic spinal manipulation']","['dACC activity', 'evoked mechanical pain', 'NPS activation', 'pain-related activity', 'Neurologic Pain Signature activation', 'evoked pain and NPS activation', 'NPS', 'SM, and evoked pain', 'neck pain', 'evoked pain, neck pain, and NPS activation', 'pain-related brain activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}]",,0.0871702,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2  = 0.477, p = 0.019).","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Weber Ii', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States. Electronic address: kenweber@stanford.edu.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Psychology and Neuroscience, Center for Neuroscience, Institute of Cognitive Science, University of Colorado Boulder, Boulder, CO, United States.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mackey', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Elliott', 'Affiliation': 'Northern Sydney Local Health District, The Kolling Research Institute and The Faculty of Health Sciences, The University of Sydney, St. Leonards, NSW, Australia.'}, {'ForeName': 'Wen-Ching', 'Initials': 'WC', 'LastName': 'Liu', 'Affiliation': 'Center for Collaborative Brain Research, Department of Radiology, OSF HealthCare Saint Francis Medical Center, Peoria, IL, United States.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Sparks', 'Affiliation': 'Center of Expertise, Rehabilitation and Occupational Health, OSF HealthCare, Peoria, IL, United States; School of Physical Therapy, South College, Knoxville, TN, United States.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102042']
259,31677411,Intranasal oxytocin enhances stress-protective effects of social support in women with negative childhood experiences during a virtual Trier Social Stress Test.,"Oxytocin is considered a biological mechanism underlying stress-protective effects of positive social interactions. It is assumed to underlie the women-specific tend-and-befriend response to stress, although few studies have tested this assertion with female samples. The aim of the present study was, therefore, to test whether oxytocin enhances stress-protective effects of social support during stress in women, taking into account the moderating role of childhood adversity. The sample consisted of 180 female undergraduate students who had reported on experiences of childhood abuse and how often their mother used love withdrawal as an insensitive disciplinary strategy. Women participated in a virtual version of the Trier Social Stress Test (TSST) and were randomly assigned to receive 24 IU oxytocin or a placebo and to receive support or no support from a female friend (sub-groups N = 45). Results showed that oxytocin reduced heart rate variability during the TSST in participants who received support, possibly indicating that oxytocin increases attention and stimulates a challenge motivational state in the presence of a friend. In addition, we found that, in the presence of a friend, oxytocin reduced state anxiety levels and cortisol levels after the TSST, but only in women with higher levels of adverse childhood experiences. Our findings may indicate that oxytocin is a neurobiological means to attain and benefit from social support under stressful circumstances, which may be particularly adaptive for women with a history of adversity. Thus, oxytocin may function as motivator for affiliative disposition during stress exposure in women with a history of childhood adversity. Results should be replicated in clinical samples.",2020,"Results showed that oxytocin reduced heart rate variability during the TSST in participants who received support, possibly indicating that oxytocin increases attention and stimulates a challenge motivational state in the presence of a friend.","['Women participated in a virtual version of the Trier Social Stress Test (TSST', 'women with a history of adversity', 'women with a history of childhood adversity', 'women with negative childhood experiences during a virtual Trier Social Stress Test', '180 female undergraduate students who had reported on experiences of childhood abuse and how often their mother used love withdrawal as an insensitive disciplinary strategy']","['24 IU oxytocin or a placebo and to receive support or no support from a female friend (sub-groups N\u202f=\u202f45', 'TSST', 'oxytocin', 'Intranasal oxytocin', 'Oxytocin']","['heart rate variability', 'challenge motivational state', 'state anxiety levels and cortisol levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",180.0,0.0662919,"Results showed that oxytocin reduced heart rate variability during the TSST in participants who received support, possibly indicating that oxytocin increases attention and stimulates a challenge motivational state in the presence of a friend.","[{'ForeName': 'M M E', 'Initials': 'MME', 'LastName': 'Riem', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, the Netherlands; Clinical Child and Family Studies, VU University Amsterdam, Amsterdam, the Netherlands. Electronic address: m.m.e.hendricx@uvt.nl.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Kunst', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, the Netherlands.'}, {'ForeName': 'M H J', 'Initials': 'MHJ', 'LastName': 'Bekker', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, the Netherlands; Department of Clinical Psychology, VU University Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fallon', 'Affiliation': 'Business School, University of Mannheim, Mannheim, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kupper', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, the Netherlands.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2019.104482']
260,31725115,Quadrivalent Influenza Vaccine Prevents Illness and Reduces Healthcare Utilization Across Diverse Geographic Regions During Five Influenza Seasons: A Randomized Clinical Trial.,"BACKGROUND


We evaluated an inactivated quadrivalent influenza vaccine (IIV4) in children 6-35 months of age in a phase III, observer-blind trial.
METHODS


The aim of this analysis was to estimate vaccine efficacy (VE) in preventing laboratory-confirmed influenza in each of 5 independent seasonal cohorts (2011-2014), as well as vaccine impact on healthcare utilization in 3 study regions (Europe/Mediterranean, Asia-Pacific and Central America). Healthy children were randomized 1:1 to IIV4 or control vaccines. VE was estimated against influenza confirmed by reverse transcription polymerase chain reaction on nasal swabs. Cultured isolates were characterized as antigenically matched/mismatched to vaccine strains.
RESULTS


The total vaccinated cohort included 12,018 children (N = 1777, 2526, 1564, 1501 and 4650 in cohorts 1-5, respectively). For reverse transcription polymerase chain reaction confirmed influenza of any severity (all strains combined), VE in cohorts 1-5 was 57.8%, 52.9%, 73.4%, 30.3% and 41.4%, respectively, with the lower limit of the 95% confidence interval >0 for all estimates. The proportion of vaccine match for all strains combined in each cohort was 0.9%, 79.3%, 72.5%, 24.1% and 28.6%, respectively. Antibiotic use associated with influenza illness was reduced with IIV4 by 71% in Europe, 36% in Asia Pacific and 59% in Central America.
CONCLUSIONS


IIV4 prevented influenza in children 6-35 months of age in each of 5 separate influenza seasons in diverse geographical regions. A possible interaction between VE, degree of vaccine match and socioeconomic status was observed. The IIV4 attenuated the severity of breakthrough influenza illness and reduced healthcare utilization, particularly antibiotic use.",2020,"Antibiotic use associated with influenza illness was reduced with IIV4 by 71% in Europe, 36% in Asia Pacific and 59% in Central America.
","['laboratory-confirmed influenza in each of 5 independent seasonal cohorts (2011-2014), as well as vaccine impact on healthcare utilization in 3 study regions (Europe/Mediterranean, Asia-Pacific and Central America', 'Healthy children', 'children 6-35 months of age in a phase III, observer-blind trial', '12,018 children (N = 1777, 2526, 1564, 1501 and 4650 in cohorts 1-5, respectively']","['IIV4 or control vaccines', 'inactivated quadrivalent influenza vaccine (IIV4']","['influenza illness', 'vaccine efficacy (VE', 'proportion of vaccine match', 'Healthcare Utilization']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0007674', 'cui_str': 'Central America'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.241299,"Antibiotic use associated with influenza illness was reduced with IIV4 by 71% in Europe, 36% in Asia Pacific and 59% in Central America.
","[{'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'Dbaibo', 'Affiliation': 'From the American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'Amanullah', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Claeys', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Izu', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Varsha K', 'Initials': 'VK', 'LastName': 'Jain', 'Affiliation': 'GSK, King of Prussia, Pennsylvania.'}, {'ForeName': 'Pope', 'Initials': 'P', 'LastName': 'Kosalaraksa', 'Affiliation': 'Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Rivera', 'Affiliation': 'National Autonomous University of Santo Domingo, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Soni', 'Affiliation': 'GSK, Bangalore, India.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Yanni', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Khalequ', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Acosta', 'Affiliation': 'Dr Castroviejo Primary Health Care Center, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ariza', 'Affiliation': 'Centro Médico Dominicano, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Arroba Basanta', 'Affiliation': 'Complutense University of Madrid, Spain.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bavdekar', 'Affiliation': 'KEM Hospital Research Centre, Pune, India.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Carmona', 'Affiliation': 'Instituto Hispalense de Pediatría, Sevilla, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Cousin', 'Affiliation': 'Tecnologia en Investigacion, San Pedro Sula, Honduras.'}, {'ForeName': 'Jasur', 'Initials': 'J', 'LastName': 'Danier', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': 'National Autonomous University of Honduras, Tegucigalpa, Honduras.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Diez-Domingo', 'Affiliation': 'FISABIO-Public Health, Valencia, Spain.'}, {'ForeName': 'Ener C', 'Initials': 'EC', 'LastName': 'Dinleyici', 'Affiliation': 'Eskisehir Osmangazi University, Eskisehir, Turkey.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Garcia-Sicilia', 'Affiliation': 'Hospital Infantil Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Grace D', 'Initials': 'GD', 'LastName': 'Gomez-Go', 'Affiliation': 'Mary Chiles General Hospital, Manila, Philippines.'}, {'ForeName': 'Maria L A', 'Initials': 'MLA', 'LastName': 'Gonzales', 'Affiliation': 'University of the Philippines, Philippine General Hospital, Manila, Philippines.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Hacimustafaoglu', 'Affiliation': 'Uludag University, Bursa, Turkey.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Hughes', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Jackowska', 'Affiliation': ''}, {'ForeName': 'Shashi', 'Initials': 'S', 'LastName': 'Kant', 'Affiliation': 'Centre for Community Medicine, All India institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Marilla', 'Initials': 'M', 'LastName': 'Lucero', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Mares Bermudez', 'Affiliation': 'Institut Pediàtric Marès-Riera, Blanes, Spain.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Martinón-Torres', 'Affiliation': 'Hospital Clínico Universitario de Santiago, Santiago, Spain.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Montellano', 'Affiliation': 'Mary Chiles General Hospital, Manila, Philippines.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Prymula', 'Affiliation': 'Charles University, Prague, School of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Center of Postgraduate Medical Education, Warsaw, PolandCenter for Excellence in Pediatric Infectious Diseases and Vaccines, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ruzkova', 'Affiliation': 'Medicentrum 6 s.r.o., Prague, Czech Republic.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Sadowska-Krawczenko', 'Affiliation': 'Nicolaus Copernicus University in Torun, Collegium Medicum, Bydgoszcz, Poland and University Hospital No 2, Bydgoszcz, Poland.'}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Szymanski', 'Affiliation': 'St. Hedwig of Silesia Hospital, Trzebnica, Poland.'}, {'ForeName': 'Angels', 'Initials': 'A', 'LastName': 'Ulied', 'Affiliation': 'EBA Centelles, Barcelona, Spain.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Woo', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schuind', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Innis', 'Affiliation': 'GSK, King of Prussia, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002504']
261,32248403,The assessment of dermatological emergencies in the emergency department via telemedicine is safe: a prospective pilot study.,"The aim of the study was to examine the feasibility and safety of telemedicine for dermatological emergency patients in the emergency department. This observational study was monocentric, open, prospective and two-arm randomized [control group (n = 50) and teledermatology group (n = 50)]. The control group was conventionally recruited directly by a dermatologist. In the teledermatology group patients, images of the skin lesions and clinical parameters were transferred to a tablet PC (personal computer) by an emergency physician and telemedically assessed by a dermatologist without patient contact. Subsequently, the dermatologist, who was previously telemedically contacted, then personally examined the patient in the emergency department. The treatment time between the control group and the teledermatology group was also recorded and compared. The agreement in suspected diagnosis between teledermatological evaluation and clinical evaluation of the same physician in the teledermatology group was 100%. The treatment time [mean (minutes) ± standard deviation] of the control group was 151 ± 71, that of the teledermatology group was 43 ± 38 (p < 0.001). The use of emergency telemedicine is safe and effective and provides a viable alternative for clinical care of emergency patients.",2020,"The treatment time [mean (minutes) ± standard deviation] of the control group was 151 ± 71, that of the teledermatology group was 43 ± 38 (p < 0.001).","['emergency patients', 'dermatological emergency patients in the emergency department']","['telemedicine', 'emergency telemedicine']","['treatment time [mean (minutes)\u2009±\u2009standard deviation', 'feasibility and safety']","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0172014,"The treatment time [mean (minutes) ± standard deviation] of the control group was 151 ± 71, that of the teledermatology group was 43 ± 38 (p < 0.001).","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Villa', 'Affiliation': 'Emergency Department, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Matz', 'Affiliation': 'Emergency Department, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany. omatz@ukaachen.de.'}, {'ForeName': 'Karmele', 'Initials': 'K', 'LastName': 'Olaciregui Dague', 'Affiliation': 'Department of Neurology, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kluwig', 'Affiliation': 'Department of Dermatology and Allergology, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Rossaint', 'Affiliation': 'Department of Anaesthesiology, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany.'}, {'ForeName': 'Jörg Christian', 'Initials': 'JC', 'LastName': 'Brokmann', 'Affiliation': 'Emergency Department, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany.'}]",Internal and emergency medicine,['10.1007/s11739-020-02323-1']
262,32248245,[Study protocol to improve the quality of delirium management in intensive care].,"BACKGROUND


Delirium in cardiac surgery patients is common and is associated with prolonged mechanical ventilation and hospital stay as well as higher mortality. Protocols may improve outcome. In our cardiac surgery intensive care unit (ICU), patients with delirium have not received standardized treatment so far.
HYPOTHESIS


In cardiac surgery ICU patients, standardized delirium management will lead after a 4‑week introduction, compared to nonstandardized treatment, to a reduction of delirium duration.
METHODS


Prospective before/after study to evaluate a quality improvement project for delirium management over 12 weeks including 140 patients.
INCLUSION CRITERIA


(a) ≥18 years, (b) consent for research with their data.
EXCLUSION CRITERIA


(a) palliative status, (b) present during both the before/after phase, (c) pregnancy, (d) included in a competitive study, or (e) delirium not assessable. The implementation includes the introduction of a protocol with interprofessional training, bedside-teaching, pocket cards, posters, and reminders. The primary outcome is the duration of delirium, assessed four times a day with validated instruments. Secondary outcome measures include delirium incidence, duration of mechanical ventilation, length of stay in ICU and hospital, mortality, nursing/therapeutic interventions, cumulative doses of delirium-related drugs, and complications of delirium for a follow-up of 28 days. Empirical data will be analyzed with descriptive and inferential statistics.
OBJECTIVES


The purpose of the study is a reduction of the duration and frequency of delirium in cardiac ICU patients and will provide evidence of the effect size of the introduction of a delirium management.",2020,"In cardiac surgery ICU patients, standardized delirium management will lead after a 4‑week introduction, compared to nonstandardized treatment, to a reduction of delirium duration.
","['patients with delirium have not received standardized treatment so far', 'cardiac surgery patients', 'delirium management over 12\xa0weeks including 140 patients', 'd)\xa0included in a\xa0competitive study, or (e)\xa0delirium not assessable', 'cardiac ICU patients']",[],"['duration of delirium, assessed four times a\xa0day with validated instruments', 'delirium incidence, duration of mechanical ventilation, length of stay in ICU and hospital, mortality, nursing/therapeutic interventions, cumulative doses of delirium-related drugs, and complications of delirium for a\xa0follow-up of 28\xa0days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0150186', 'cui_str': 'Delirium management'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.178758,"In cardiac surgery ICU patients, standardized delirium management will lead after a 4‑week introduction, compared to nonstandardized treatment, to a reduction of delirium duration.
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mohammad', 'Affiliation': 'Klinik für Herz und Gefäßchirurgie, Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nydahl', 'Affiliation': 'Pflegeforschung; Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein Campus Kiel, Brunswiker Str.\xa010, 24116, Kiel, Deutschland. peter.nydahl@uksh.de.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Borzikowsky', 'Affiliation': 'Institut für Medizinische Informatik und Statistik, Christian-Albrechts-Universität zu Kiel, Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Margraf', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Studt', 'Affiliation': 'Klinik für Integrative Psychiatrie ZIP gGmbH, Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Meyne', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kott', 'Affiliation': 'Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Deutschland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Panholzer', 'Affiliation': 'Klinik für Herz- und Gefäßchirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Deutschland.'}]","Medizinische Klinik, Intensivmedizin und Notfallmedizin",['10.1007/s00063-020-00676-1']
263,32247522,Effect of Ketamine Added to Ropivacaine in Nerve Block for Postoperative Pain Management in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Trial.,"PURPOSE


Nerve blocks are commonly used as a part of multimodal pain relief. It was previously shown that ketamine could enhance the analgesic effect of local anesthetics in nerve blocks. A literature review on adding ketamine to local anesthetics for ameliorating analgesia revealed inconsistencies in analgesic efficiency and safety. This prospective, randomized, double-blind trial was performed to evaluate the antinociceptive effect of mixing ketamine with local anesthetics in a combined femoral and sciatic nerve block (CFSNB) during anterior cruciate ligament (ACL) reconstruction.
METHODS


Seventy-six patients undergoing preoperative ultrasound-guided CFSNB in ACL reconstruction were enrolled. Patients were randomly assigned to 3 groups: Group RNK received perineural administration of 40-mg ketamine plus 0.375% ropivacaine in 40-mL volume; Group RIK received 40 mL of 0.375% ropivacaine, as well as IV ketamine 40 mg; and Group R received 40 mL of 0.375% ropivacaine. Pain scores were recorded. AUC was calculated based on the pain scores at different times. Duration of CFSNB, postoperative analgesic demand, time to first analgesic demand, and adverse events were also examined.
FINDINGS


Perineural ketamine decreased pain scores 20 and 24 h' postoperatively, as well as lowered AUC values (all, P = 0.001). Group RNK had a prolonged time to first analgesic request (P = 0.014), inhibited rebound pain (P = 0.001), and increased satisfactory score at 48 h' postsurgery (P = 0.001). Perineural ketamine prolonged the duration of sensory block (P = 0.001) with no effect on early mobilization. There were no significant differences between Group R and Group RIK in terms of postoperative pain scores, AUC of different time intervals (P = 0.832 or more), and time to first rescue analgesics (P = 0.585). Compared with the 2 other groups, IV ketamine had a higher incidence of hallucination after operations.
IMPLICATIONS


Perineural ketamine added to the ropivacaine-enhanced analgesic efficacy of CFSNB with less rebound pain compared with the IV ketamine and control groups. IV ketamine had no effect in potentiating analgesia when a conventional multimodal approach was used in the study. Chinese Clinical Trial Registry: ChiCTR1900023867.",2020,"There were no significant differences between Group R and Group RIK in terms of postoperative pain scores, AUC of different time intervals (P = 0.832 or more), and time to first rescue analgesics (P = 0.585).","['Seventy-six patients undergoing preoperative ultrasound-guided CFSNB in ACL reconstruction were enrolled', 'anterior cruciate ligament (ACL) reconstruction', 'Patients Undergoing Anterior Cruciate Ligament Reconstruction']","['Ropivacaine', 'ketamine', 'mixing ketamine with local anesthetics', 'perineural administration of 40-mg ketamine plus 0.375% ropivacaine in 40-mL volume; Group RIK received 40\xa0mL of 0.375% ropivacaine', 'ketamine 40\xa0mg; and Group R received 40\xa0mL of 0.375% ropivacaine', 'ropivacaine', 'CFSNB', 'Ketamine']","['inhibited rebound pain', 'Duration of CFSNB, postoperative analgesic demand, time to first analgesic demand, and adverse events', 'analgesic efficiency and safety', 'Pain scores', 'satisfactory score', 'postoperative pain scores, AUC of different time intervals', 'analgesic efficacy', 'Postoperative Pain Management', 'lowered AUC values', 'antinociceptive effect', 'prolonged time to first analgesic request', 'pain scores', 'time to first rescue analgesics', 'potentiating analgesia', 'duration of sensory block']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1518982', 'cui_str': 'Perineural route'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441852', 'cui_str': 'Group R'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",76.0,0.126864,"There were no significant differences between Group R and Group RIK in terms of postoperative pain scores, AUC of different time intervals (P = 0.832 or more), and time to first rescue analgesics (P = 0.585).","[{'ForeName': 'Tianqi', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, 1st Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, 1st Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Ximou', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, 2nd Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Shuying', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Anesthesiology, 2nd Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Wendong', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, 1st Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Jiehao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, 1st Affiliated Hospital, Wenzhou Medical University, Wenzhou, China. Electronic address: sun_jiehao@126.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.03.004']
264,32234665,Randomised phase II trial (SWOG S1310) of single agent MEK inhibitor trametinib Versus 5-fluorouracil or capecitabine in refractory advanced biliary cancer.,"BACKGROUND


The rationale for the evaluation of trametinib in advanced biliary cancer (BC) is based on the presence of mitogen-activated protein kinase alterations and on earlier promising results with MEK inhibitors in BC.
METHODS


Patients with histologically proven BC who progressed on gemcitabine/platinum were randomised to trametinib daily (arm 1) versus fluoropyrimidine therapy (infusional 5-fluorouracil or oral capecitabine, arm 2). The primary end-point was overall survival (OS). Secondary end-points included progression free survival (PFS) and response rate. A planned interim futility analysis of objective response was performed on the first 14 patients registered to the trametinib arm.
RESULTS


The study was stopped early based on the lack of measurable response in the trametinib arm. A total of 44 eligible patients were randomised (24 patients in arm 1 and 20 patients in arm 2). Median age was 62 years and the primary sites of tumour were cholangiocarcinoma (68%) and gallbladder (32%). The overall response rate was 8% (95% CI 0%-19%) in arm 1 versus 10% (95% CI 0%-23%) in arm 2 (p > .99) Median OS was 4.3 months for arm 1 and 6.6 months for arm 2. The median PFS was 1.4 months for arm 1 and 3.3 months for arm 2.
CONCLUSIONS


This is the first prospective randomised study of a targeted agent versus chemotherapy for the second-line treatment of BC. In this unselected population, the interim analysis result of unlikely benefit with trametinib resulted in early closure.",2020,The overall response rate was 8% (95% CI 0%-19%) in arm 1 versus 10% (95% CI 0%-23%) in arm 2 (p > .99),"['refractory advanced biliary cancer', '14 patients registered to the trametinib arm', 'advanced biliary cancer (BC', '44 eligible patients were randomised (24 patients in arm 1 and 20 patients in arm 2', 'Patients with histologically proven BC who progressed on', 'Median age was 62 years and the primary sites of tumour were cholangiocarcinoma (68%) and gallbladder (32']","['single agent MEK inhibitor trametinib Versus 5-fluorouracil or capecitabine', 'fluoropyrimidine therapy (infusional 5-fluorouracil or oral capecitabine, arm 2', 'chemotherapy', 'gemcitabine/platinum']","['overall survival (OS', 'overall response rate', 'median PFS', 'progression free survival (PFS) and response rate', 'Median OS']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C2347168', 'cui_str': 'Mitogen-activated protein kinase kinase inhibitor'}, {'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",44.0,0.105151,The overall response rate was 8% (95% CI 0%-19%) in arm 1 versus 10% (95% CI 0%-23%) in arm 2 (p > .99),"[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Kim', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA. Electronic address: Richard.Kim@moffitt.org.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'McDonough', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Tanios S', 'Initials': 'TS', 'LastName': 'Bekaii-Saab', 'Affiliation': 'Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Stein', 'Affiliation': 'Rutgers Cancer Institute, New Brunswick, NJ, USA.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Sahai', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'George P', 'Initials': 'GP', 'LastName': 'Keogh', 'Affiliation': 'Charleston Hematology Oncology Associates, Southeast COR NCORP, Charleston, SC, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'University of California Davis Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Ari D', 'Initials': 'AD', 'LastName': 'Baron', 'Affiliation': 'California Pacific Medical Center/Sutter Cancer Research Consortium, San Francisco, CA, USA.'}, {'ForeName': 'Abby B', 'Initials': 'AB', 'LastName': 'Siegel', 'Affiliation': 'Columbia University, Columbia MU-NCORP, New York, NY, USA.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Barzi', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Javle', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Hochster', 'Affiliation': 'Rutgers Cancer Institute, New Brunswick, NJ, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.01.026']
265,32248771,Thrombolysis With Alteplase at 0.6 mg/kg for Stroke With Unknown Time of Onset: A Randomized Controlled Trial.,"Background and Purpose- We assessed whether lower-dose alteplase at 0.6 mg/kg is efficacious and safe for acute fluid-attenuated inversion recovery-negative stroke with unknown time of onset. Methods- This was an investigator-initiated, multicenter, randomized, open-label, blinded-end point trial. Patients met the standard indication criteria for intravenous thrombolysis other than a time last-known-well >4.5 hours (eg, wake-up stroke). Patients were randomly assigned (1:1) to receive alteplase at 0.6 mg/kg or standard medical treatment if magnetic resonance imaging showed acute ischemic lesion on diffusion-weighted imaging and no marked corresponding hyperintensity on fluid-attenuated inversion recovery. The primary outcome was a favorable outcome (90-day modified Rankin Scale score of 0-1). Results- Following the early stop and positive results of the WAKE-UP trial (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke), this trial was prematurely terminated with 131 of the anticipated 300 patients (55 women; mean age, 74.4±12.2 years). Favorable outcome was comparable between the alteplase group (32/68, 47.1%) and the control group (28/58, 48.3%; relative risk [RR], 0.97 [95% CI, 0.68-1.41];  P =0.892). Symptomatic intracranial hemorrhage within 22 to 36 hours occurred in 1/71 and 0/60 (RR, infinity [95% CI, 0.06 to infinity];  P >0.999), respectively. Death at 90 days occurred in 2/71 and 2/60 (RR, 0.85 [95% CI, 0.06-12.58];  P >0.999), respectively. Conclusions- No difference in favorable outcome was seen between alteplase and control groups among patients with ischemic stroke with unknown time of onset. The safety of alteplase at 0.6 mg/kg was comparable to that of standard treatment. Early study termination precludes any definitive conclusions. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02002325.",2020,No difference in favorable outcome was seen between alteplase and control groups among patients with ischemic stroke with unknown time of onset.,"['300 patients (55 women; mean age, 74.4±12.2 years', 'Patients met the standard indication criteria for intravenous thrombolysis other than a time last-known-well >4.5 hours (eg, wake-up stroke', 'Onset']","['MRI-Based Thrombolysis', 'alteplase at 0.6 mg/kg or standard medical treatment if magnetic resonance imaging', 'Methods', 'Conclusions', ' and Purpose', 'Thrombolysis With Alteplase']","['Death', 'Symptomatic intracranial hemorrhage', 'favorable outcome (90-day modified Rankin Scale score of 0-1']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",300.0,0.306085,No difference in favorable outcome was seen between alteplase and control groups among patients with ischemic stroke with unknown time of onset.,"[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Koko', 'Initials': 'K', 'LastName': 'Asakura', 'Affiliation': 'Department of Data Science (K.A., T.H., M.F-D.), National Cerebral and Cardiovascular Center, Suita.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Aoki', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo (J.A., K. Kimura).'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Hamasaki', 'Affiliation': 'Department of Data Science (K.A., T.H., M.F-D.), National Cerebral and Cardiovascular Center, Suita.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Kanzawa', 'Affiliation': 'Department of Stroke Medicine, Institute of Brain and Blood Vessels, Mihara Memorial Hospital, Isesaki (T. Kanzawa).'}, {'ForeName': 'Rei', 'Initials': 'R', 'LastName': 'Kondo', 'Affiliation': 'Department of Neurosurgery, Yamagata City Hospital Saiseikan (R. Kondo).'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ohtaki', 'Affiliation': 'Department of Neurosurgery, Obihiro Kosei Hospital (M. Ohtaki).'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Itabashi', 'Affiliation': 'Department of Stroke Neurology, Kohnan Hospital, Sendai (R.I.).'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Neurosurgery, Nakamura Memorial Hospital, Sapporo (K. Kamiyama).'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Iwama', 'Affiliation': 'Department of Neurosurgery, Gifu University School of Medicine (T. Iwama).'}, {'ForeName': 'Taizen', 'Initials': 'T', 'LastName': 'Nakase', 'Affiliation': 'Department of Stroke Science, Research Institute for Brain and Blood Vessels, Akita (T.N.).'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yakushiji', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Saga University Faculty of Medicine (Y.Y.).'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Igarashi', 'Affiliation': 'Department of Neurology, Niigata City General Hospital (S.I.).'}, {'ForeName': 'Yoshinari', 'Initials': 'Y', 'LastName': 'Nagakane', 'Affiliation': 'Department of Neurology, Kyoto Second Red Cross Hospital (Y.N.).'}, {'ForeName': 'Shunya', 'Initials': 'S', 'LastName': 'Takizawa', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Tokai University School of Medicine, Isehara (S.T.).'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Department of Cerebrovascular Medicine and Neurology, Cerebrovascular Center, National Hospital Organization Kyushu Medical Center, Fukuoka (Y.O.).'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Doijiri', 'Affiliation': 'Department of Neurology, Iwate Prefectural Central Hospital, Morioka (R.D.).'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsujino', 'Affiliation': 'Department of Neurology and Strokology, Nagasaki University Graduate School of Biomedical Sciences (A.T.).'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Neurology, Toyota Memorial Hospital (Y.I.).'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ohnishi', 'Affiliation': 'Department of Neurosurgery, Ohnishi Neurological Center, Akashi (H.O.).'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Stroke Medicine, Kawasaki Medical School General Medical Center, Okayama (T. Inoue).'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takagi', 'Affiliation': 'Department of Neurosurgery, Tokushima University (Y.T.).'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Neurology, St. Marianna University School of Medicine, Kawasaki (Y.H.).'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Shiokawa', 'Affiliation': 'Department of Neurosurgery, Kyorin University School of Medicine, Mitaka (Y.S.).'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Sakai', 'Affiliation': 'Department of Neurosurgery, Kobe City Medical Center General Hospital (N.S.).'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Osaki', 'Affiliation': 'Department of Cerebrovascular Medicine, Stroke Center, Steel Memorial Yawata Hospital, Kitakyushu (M.O.).'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Uesaka', 'Affiliation': 'Department of Neurology, Toranomon Hospital, Tokyo (Y.U.).'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Neurosurgery, Hyogo College of Medicine, Nishinomiya (S. Yoshimura).'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Urabe', 'Affiliation': 'Department of Neurology, Juntendo University Urayasu Hospital (T. Urabe).'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Strokology, Stroke Center, St. Marianna University Toyoko Hospital, Kawasaki (T. Ueda).'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ihara', 'Affiliation': 'Department of Neurology (M. Ihara), National Cerebral and Cardiovascular Center, Suita.'}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka (T. Kitazono).'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Sasaki', 'Affiliation': 'Institute for Biomedical Sciences, Iwate Medical University, Yahaba (M.S.).'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Oita', 'Affiliation': 'Department of Pharmacy (A.O.), National Cerebral and Cardiovascular Center, Suita.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Fukuda-Doi', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Miwa', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo (J.A., K. Kimura).'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028127']
266,32251060,"Subcutaneous Tocilizumab in Monotherapy or in Combination With Nonbiologic Disease-Modifying Antirheumatic Drugs in Latin American Patients With Moderate to Severe Active Rheumatoid Arthritis: A Multicenter, Phase IIIb Study.","OBJECTIVE


To assess the efficacy and safety of subcutaneous tocilizumab (TCZ) in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in Latin American patients with rheumatoid arthritis (RA) and inadequate response to previous csDMARDs.
METHODS


ML28700 was a multicenter, open-label, single-arm trial. Previously treated RA patients who had not received treatment with TCZ or any biological agent (n = 284) and with a baseline Disease Activity Score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) of 3.2 or greater were assigned to receive subcutaneous TCZ (162 mg/wk) in association with csDMARD for 24 weeks. Patients who achieved remission (DAS28-ESR <2.6) at week 24 continued with TCZ as monotherapy until week 52; otherwise, they continued with their assigned treatment. The primary efficacy end point was remission rate (DAS28-ESR <2.6) at weeks 24 and 52. Secondary objectives included disease activity scores, safety, and quality of life.
RESULTS


At week 24, a total of 169 patients (59.5%; 95% confidence interval, 53.5%-65.3%) achieved remission, 91 patients (32.0%) had low disease activity, and 46 patients (8.4%) were not responders. Sustained remission at week 52 was achieved by 80.8% (n = 126) of patients who continued with TCZ monotherapy versus 44.6% (n = 37) of those on combination therapy. A total of 241 patients (84.9%; 95% confidence interval, 80.2%-88.8%) had at least 1 adverse event during follow-up. Adverse events led to drug modification in 32 patients (11.3%) or discontinuation in 21 patients (7.4%).
CONCLUSIONS


Subcutaneous TCZ is an efficacious therapy with long-lasting results and tolerable adverse events in Latin American patients with RA.Trial registration no.: NCT02011334 Tozura Study Program.",2020,Subcutaneous TCZ is an efficacious therapy with long-lasting results and tolerable adverse events in Latin American patients with RA.Trial registration no.:,"['Latin American patients with rheumatoid arthritis (RA', 'Patients who achieved remission (DAS28-ESR <2.6) at week 24 continued with', 'Latin American Patients With Moderate to Severe Active Rheumatoid Arthritis', 'Latin American patients with RA.Trial registration no']","['subcutaneous TCZ', 'TCZ or any biological agent', 'Monotherapy or in Combination With Nonbiologic Disease-Modifying Antirheumatic Drugs', 'conventional synthetic disease-modifying antirheumatic drugs (csDMARDs', 'TCZ monotherapy', 'Subcutaneous TCZ', 'subcutaneous tocilizumab (TCZ', 'Subcutaneous Tocilizumab', 'TCZ']","['remission rate', 'disease activity scores, safety, and quality of life', 'low disease activity', 'Sustained remission', 'erythrocyte sedimentation rate (DAS28-ESR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}]",284.0,0.0901257,Subcutaneous TCZ is an efficacious therapy with long-lasting results and tolerable adverse events in Latin American patients with RA.Trial registration no.:,"[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Mysler', 'Affiliation': 'From the Organización Medica de Investigación, Buenos Aires, Argentina.'}, {'ForeName': 'Mario H', 'Initials': 'MH', 'LastName': 'Cardiel', 'Affiliation': 'Centro de Investigación Clínica de Morelia, SC, Morelia, Michoacán, México.'}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Xavier', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'López', 'Affiliation': 'Roche Servicios S.A.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Ramos-Esquivel', 'Affiliation': 'Department of Pharmacology, School of Medicine, University of Costa Rica, San José, Costa Rica.'}]",Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases,['10.1097/RHU.0000000000001361']
267,32246662,Comparative efficacy of medical treatment versus surgical sphincterotomy in the treatment of chronic anal fissure.,"Background


Anal fissure which is defined as a longitudinal tear in anoderm below the dentate line is one of the most common benign diseases of anorectal area. Severe pain during the defecation and emotional stress that it causes may reduce people's quality of life.
Aims


In this randomized clinical trial, we aimed to compare the efficiency of the topical ointment with medical treatment and surgical lateral internal sphincterotomy.
Method


This is a randomized clinical trial of 550 patients who were treated for chronic anal fissure. Patients were randomly divided into 4 groups according to the treatment type they received.
Results


In a vast majority of the patients, the primary complaint was pain (92.3%) and bleeding during defecation (62%). Both pain relief and healing of the fissure, which are the components of response to treatment, had not been observed in 56 (37.3%) patients of topical nitroglycerin ointment group until the second month. Among the recalcitrant patients in both topical nitroglycerin (56) and topical diltiazem ointment (47) groups, 27 (48.2%), and 36 (76.5%) patients underwent surgery, respectively. The best response to treatment was also obtained in lateral internal sphincterotomy group.
Conclusion


LIS is still the gold standard for the treatment of chronic anal fissure when the physicians would like to avoid recurrence and obtain the best pain relief.",2020,"Both pain relief and healing of the fissure, which are the components of response to treatment, had not been observed in 56 (37.3%) patients of topical nitroglycerin ointment group until the second month.","['chronic anal fissure', '550 patients who were treated for chronic anal fissure']","['topical diltiazem ointment', 'topical ointment with medical treatment and surgical lateral internal sphincterotomy', 'medical treatment versus surgical sphincterotomy', 'topical nitroglycerin', 'nitroglycerin ointment']","['pain', 'Severe pain', 'bleeding during defecation', 'pain relief and healing of the fissure']","[{'cui': 'C0349071', 'cui_str': 'Chronic anal fissure'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0991554', 'cui_str': 'Cutaneous ointment'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0400249', 'cui_str': 'Lateral sphincterotomy'}, {'cui': 'C0177047', 'cui_str': 'Sphincterotomy (bladder)'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C1248486', 'cui_str': 'Nitroglycerin Topical Ointment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}]",550.0,0.0316533,"Both pain relief and healing of the fissure, which are the components of response to treatment, had not been observed in 56 (37.3%) patients of topical nitroglycerin ointment group until the second month.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Acar', 'Affiliation': 'Department of General Surgery, Atatürk Training and Research Hospital, İzmir Katip Çelebi University, Çigli, İzmir, Turkey.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Acar', 'Affiliation': 'Department of General Surgery, Atatürk Training and Research Hospital, İzmir Katip Çelebi University, Çigli, İzmir, Turkey.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Güngör', 'Affiliation': 'Department of General Surgery, Atatürk Training and Research Hospital, İzmir Katip Çelebi University, Çigli, İzmir, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kamer', 'Affiliation': 'Department of General Surgery, Atatürk Training and Research Hospital, İzmir Katip Çelebi University, Çigli, İzmir, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Genç', 'Affiliation': 'Department of General Surgery, Atatürk Training and Research Hospital, İzmir Katip Çelebi University, Çigli, İzmir, Turkey.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Atahan', 'Affiliation': 'Department of General Surgery, Atatürk Training and Research Hospital, İzmir Katip Çelebi University, Çigli, İzmir, Turkey.'}, {'ForeName': 'O N', 'Initials': 'ON', 'LastName': 'Dilek', 'Affiliation': 'Department of General Surgery, Atatürk Training and Research Hospital, İzmir Katip Çelebi University, Çigli, İzmir, Turkey.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hacıyanlı', 'Affiliation': 'Department of General Surgery, Atatürk Training and Research Hospital, İzmir Katip Çelebi University, Çigli, İzmir, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_383_19']
268,32244424,Effects of Double-Taped Kinesio Taping on Pain and Functional Performance due to Muscle Fatigue in Young Males: A Randomized Controlled Trial.,"Kinesio taping (KT) is widely applied for pain control and rehabilitation in clinical settings. Tape tension is a key factor in the taping method. However, limited evidence exists regarding the reinforced tension effects of KT on functional performance and pain in healthy individuals. This study aimed to investigate the immediate effects of double-taped Kinesio taping (DTKT) on functional performance and pain caused by muscle fatigue after exercise. A total of 44 healthy male students (mean age, 23.3 ± 2.2 years) were randomly assigned to the following three groups: DTKT, normal-tape Kinesio taping (NTKT), and placebo. The single-hopping (SH) distance, vertical jump height (VJH), and power (VJP) were assessed at baseline. The muscle fatigue protocol was then applied to induce muscle soreness. Outcome measures including subjective pain, SH distance, VJH and VJP were evaluated immediately after the muscle fatigue protocol, and KT was then applied; the measures were then again evaluated immediately and 24 h after KT application. No significant interactions between pain and functional performance were observed ( p  > 0.05), and there were no significant differences in SH, VJH, and VJP among the groups ( p  > 0.05). Notably, the DTKT had an immediate effect on the alleviation of pain caused by muscle fatigue. The present findings indicate that DTKT is not superior to NTKT or placebo in terms of pain relief and enhancing functional performance after tape application in healthy male students.",2020,"Outcome measures including subjective pain, SH distance, VJH and VJP were evaluated immediately after the muscle fatigue protocol, and KT was then applied; the measures were then again evaluated immediately and 24 h after KT application.","['44 healthy male students (mean age, 23.3 ± 2.2 years', 'healthy individuals', 'Young Males', 'healthy male students']","['placebo', 'Double-Taped Kinesio Taping', 'Kinesio taping (KT', 'normal-tape Kinesio taping (NTKT), and placebo', 'KT', 'double-taped Kinesio taping (DTKT']","['SH, VJH, and VJP', 'single-hopping (SH) distance, vertical jump height (VJH), and power (VJP', 'Pain and Functional Performance', 'alleviation of pain', 'pain and functional performance', 'functional performance and pain', 'pain relief and enhancing functional performance', 'subjective pain, SH distance, VJH and VJP']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",44.0,0.0629081,"Outcome measures including subjective pain, SH distance, VJH and VJP were evaluated immediately after the muscle fatigue protocol, and KT was then applied; the measures were then again evaluated immediately and 24 h after KT application.","[{'ForeName': 'Haneul', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Gachon University, Inchon 21936, Korea.'}, {'ForeName': 'Hyoungwon', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Therapy, Dankook University, Cheonan 31116, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17072364']
269,32224082,Orthognathic Surgery-Induced Fibrinolytic Shutdown Is Amplified by Tranexamic Acid.,"PURPOSE


Little is known of the systemic effects of oral and maxillofacial surgery on the hemostatic balance, including the biochemical effects of tranexamic acid (TXA), on fibrin clot lysis. The present study investigated the effects of orthognathic surgery on fibrin lysis, fibrin structure, and D-dimer and evaluated the effect of TXA on these fibrinolytic measures.
MATERIALS AND METHODS


The present double-blind, controlled, and randomized, placebo study included patients referred to the Department of Oral and Maxillofacial Surgery at the University Hospital of Southern Denmark-Esbjerg from August 2014 through September 2016. The patients were elective and had a diagnosis of maxillary or mandibular deficiency, either excessive or asymmetric. All patients underwent bimaxillary orthognathic surgery (OS) with or without maxillary segmentation or additional genioplasty. The patients were blindly randomized to treatment with TXA or placebo. The primary predictor variable was OS. The secondary predictor variable was an intravenous dose of 1 g of TXA or equivalent placebo preoperatively. Blood samples were collected before surgery and 5 hours after the initiation of surgery. The primary outcome variable was lysis of fibrin. The fibrin structure properties and D-dimer were secondary outcome measures. The Mann-Whitney U test was used for the within-group comparisons. The Wilcoxon signed rank test was used for the between-group comparisons.
RESULTS


The sample included 96 patients; 45 received placebo and 51 received TXA. Fibrin lysis decreased after OS (P < .001). The fibrinolytic shutdown decreased significantly more in the TXA group than in the placebo group (P < .001). OS altered the fibrin structure properties with comparable effects in the 2 groups. D-dimer increased postoperatively but significantly less so in the TXA group than in the control group (P < .001).
CONCLUSIONS


OS is associated with fibrinolytic shutdown and alters fibrin structure properties, driving the hemostatic balance in a prothrombotic direction. The fibrinolytic shutdown is significantly amplified by TXA.",2020,"D-dimer increased postoperatively but significantly less so in the TXA group than in the control group (P < .001).
","['patients were elective and had a diagnosis of maxillary or mandibular deficiency, either excessive or asymmetric', 'patients referred to the Department of Oral and Maxillofacial Surgery at the University Hospital of Southern Denmark-Esbjerg from August 2014 through September 2016', 'The sample included 96 patients; 45 had received']","['Tranexamic Acid', 'placebo', 'maxillofacial surgery', 'bimaxillary orthognathic surgery (OS) with or without maxillary segmentation or additional genioplasty', 'TXA', 'TXA or placebo', 'tranexamic acid (TXA', 'orthognathic surgery']","['Blood samples', 'Fibrin lysis', 'lysis of fibrin', 'OS', 'fibrinolytic shutdown', 'fibrin lysis, fibrin structure, and D-dimer']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0700381', 'cui_str': 'Segmentation (qualifier value)'}, {'cui': 'C0398907', 'cui_str': 'Chin Repositioning'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}]",96.0,0.195453,"D-dimer increased postoperatively but significantly less so in the TXA group than in the control group (P < .001).
","[{'ForeName': 'Johannes J', 'Initials': 'JJ', 'LastName': 'Sidelmann', 'Affiliation': 'Associate Professor, Unit for Thrombosis Research, Department of Regional Health Research, University of Southern Denmark; and Department of Clinical Biochemistry, University Hospital of Southern Denmark - Esbjerg, Esbjerg, Denmark. Electronic address: johannes.sidelmann@rsyd.dk.'}, {'ForeName': 'Jørgen B', 'Initials': 'JB', 'LastName': 'Gram', 'Affiliation': 'Professor, Unit for Thrombosis Research, Department of Regional Health Research, University of Southern Denmark; and Department of Clinical Biochemistry, University Hospital of Southern Denmark - Esbjerg, Esbjerg, Denmark.'}, {'ForeName': 'Anne C M', 'Initials': 'ACM', 'LastName': 'Godtfredsen', 'Affiliation': 'Research Fellow, Unit for Thrombosis Research, Department of Regional Health Research, University of Southern Denmark; and Department of Clinical Biochemistry, University Hospital of Southern Denmark - Esbjerg, Esbjerg, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Thorn', 'Affiliation': 'Head of Department, Department of Oral and Maxillofacial Surgery, University Hospital of Southern Denmark - Esbjerg, Esbjerg, Denmark.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Ingerslev', 'Affiliation': 'Senior Consultant, Department of Oral and Maxillofacial Surgery, University Hospital of Southern Denmark - Esbjerg, Esbjerg, Denmark.'}, {'ForeName': 'Else M', 'Initials': 'EM', 'LastName': 'Pinholt', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, University Hospital of Southern Denmark - Esbjerg; and Department of Regional Health Research, University of Southern Denmark, Esbjerg, Denmark.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.02.026']
270,31795041,Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder.,"Real-time functional magnetic resonance imaging (fMRI) neurofeedback training of amygdala hemodynamic activity directly targets a neurobiological mechanism, which contributes to emotion regulation problems in borderline personality disorder (BPD). However, it remains unknown which outcome measures can assess changes in emotion regulation and affective instability, associated with amygdala downregulation in a clinical trial. The current study directly addresses this question. Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback. Before and after the training, as well as at a six-weeks follow-up assessment, participants completed measures of emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI). Participants were able to downregulate their amygdala blood oxygen-dependent (BOLD) response with neurofeedback. There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training. Further explorative analyses suggest that patients indicated less affective instability, as seen by lower hour-to-hour variability in negative affect and inner tension in daily life. If replicated by an independent study, our results imply changes in emotion regulation and affective instability for several systems levels, including behavior and verbal report. Conclusions are limited due to the lack of a control group. A randomized controlled trial (RCT) will be needed to confirm effectiveness of the training.",2019,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"['patients with borderline personality disorder', 'borderline personality disorder (BPD', 'Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback']",[],"['emotion-modulated startle to negative pictures', 'emotion regulation and affective instability', 'amygdala blood oxygen-dependent (BOLD) response with neurofeedback', 'affective instability', 'emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI', 'emotion regulation', 'Zanarini rating scale for BPD (ZAN-BPD', 'BPD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0460109', 'cui_str': 'Verbal report'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",24.0,0.0423346,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zaehringer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany. Electronic address: jenny.zaehringer@zi-mannheim.de.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ende', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Santangelo', 'Affiliation': 'Chair of Applied Psychology/Mental Health Lab, Institute of Sport and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Kleindienst', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Ruf', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department for General Psychiatry, Center of Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany; Department of Psychology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bohus', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmahl', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Paret', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany; Sagol Brain Institute, Wohl Institute for Advanced Imaging, Tel-Aviv Sourasky Medical Center and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: christian.paret@zi-mannheim.de.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102032']
271,31820339,"A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera ® ) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL).","BACKGROUND


Biosimilars are highly similar to the licensed biologic (""reference product""), with no clinically meaningful differences in safety, purity, or potency between the two products.
OBJECTIVE


This comparative 52-week clinical study evaluated the efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-05280586 (Ruxience™ [a rituximab biosimilar]) versus rituximab reference product sourced from the EU (MabThera ® ; rituximab-EU).
PATIENTS AND METHODS


Subjects with CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL) and an Eastern Cooperative Oncology Group performance status 0-1 were randomized (1:1) to PF-05280586 or rituximab-EU (375 mg/m 2  intravenously [once weekly for 4 weeks at days 1, 8, 15, and 22]), stratified using the Follicular Lymphoma International Prognostic Index 2 classification. The primary endpoint was overall response rate (ORR) at week 26 (percentage of subjects achieving complete response [CR] or partial response [PR]). Therapeutic equivalence was concluded if the two-sided 95% confidence interval (CI) for the difference in ORR between groups was within the prespecified margin (± 16%). Secondary endpoints included progression-free survival (PFS), CR rate, safety, immunogenicity, PK, and PD.
RESULTS


A total of 394 subjects were randomized: PF-05280586 (n = 196) or rituximab-EU (n = 198). ORR at week 26 was 75.5% (PF-05280586) versus 70.7% (rituximab-EU), for a difference of 4.66%; 95% CI (- 4.16 to 13.47), which was entirely within the prespecified equivalence margin. Rates of CR were 29.3% (PF-05280586) versus 31.0% (rituximab-EU). Estimated 1-year PFS rates were 78.2% (95% CI 70.2-84.2) and 83.0% (95% CI 75.0-88.6) for PF-05280586 and rituximab-EU, respectively. Safety, immunogenicity, and mean serum concentrations were similar between groups.
CONCLUSIONS


The efficacy, safety, immunogenicity, PK, and PD of PF-05280586 and rituximab-EU were similar up to week 52 in subjects with previously untreated CD20-positive LTB-FL.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02213263 and EudraCT (2014-000132-41).",2020,"Estimated 1-year PFS rates were 78.2% (95% CI 70.2-84.2) and 83.0% (95% CI 75.0-88.6) for PF-05280586 and rituximab-EU, respectively.","['Subjects with CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL) and an Eastern Cooperative Oncology Group performance status 0-1', 'subjects with previously untreated CD20-positive LTB-FL', 'A total of 394 subjects', 'Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL']","['rituximab-EU', 'PF-05280586 or rituximab-EU', 'Rituximab Reference Product (MabThera ® ', 'rituximab reference product sourced from the EU (MabThera ® ; rituximab-EU', 'PF-05280586 (a Rituximab Biosimilar', 'PF-05280586']","['Therapeutic equivalence', 'Rates of CR', 'progression-free survival (PFS), CR rate, safety, immunogenicity, PK, and PD', 'efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD', 'overall response rate (ORR', 'Estimated 1-year PFS rates', 'complete response [CR] or partial response [PR', 'Safety, immunogenicity, and mean serum concentrations', 'ORR', 'efficacy, safety, immunogenicity, PK, and PD of PF-05280586 and rituximab-EU']","[{'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C1664181', 'cui_str': 'LTB protein, human'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1314901', 'cui_str': 'Mabthera'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",394.0,0.51071,"Estimated 1-year PFS rates were 78.2% (95% CI 70.2-84.2) and 83.0% (95% CI 75.0-88.6) for PF-05280586 and rituximab-EU, respectively.","[{'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': 'Willamette Valley Cancer Institute and Research Center, US Oncology, 520 Country Club Rd, Eugene, OR, 97401, USA.'}, {'ForeName': 'Anna Marina', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Università degli Studi di Perugia, S.C. Oncoematologia-A.O. Santa Maria, 05100, Terni, Italy.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Ishizawa', 'Affiliation': 'Department of Third Internal Medicine, Faculty of Medicine, Yamagata University, 2-2-2 Iida-Nishi, Yamagata, 990-9585, Japan.'}, {'ForeName': 'Tahira', 'Initials': 'T', 'LastName': 'Khan', 'Affiliation': 'Pfizer Inc, 445 Eastern Point Rd, Groton, 06340, CT, USA. Tahira.Khan@pfizer.com.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Robbins', 'Affiliation': 'Pfizer Inc, 445 Eastern Point Rd, Groton, 06340, CT, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Alcasid', 'Affiliation': 'Pfizer Inc, 500 Arcola Rd, Collegeville, 19426, PA, USA.'}, {'ForeName': 'Julie Ann', 'Initials': 'JA', 'LastName': 'Rosenberg', 'Affiliation': 'Pfizer Inc, 445 Eastern Point Rd, Groton, 06340, CT, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Aurer', 'Affiliation': 'University Hospital Centre Zagreb, Kišpatićeva ul. 12, 10000, Zagreb, Croatia.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-019-00398-7']
272,32052313,"Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity of DRL_RI Versus Reference Rituximab in Biologics-Naïve Patients with Moderate-to-Severe Rheumatoid Arthritis: A Double-Blind, Randomized, Three-Arm Study.","OBJECTIVES


The aims were to demonstrate pharmacokinetic (PK) similarity between DRL_RI, a proposed rituximab biosimilar, and two reference innovator products (Rituxan ®  [RTX-US] and MabThera ®  [RTX-EU]) and compare their pharmacodynamics (PD), efficacy, safety, and immunogenicity in rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX)-based therapy and no prior biologic administration.
METHODS


In this randomized, double-blind, parallel-group study, 276 patients with moderate-to-severe active RA were randomized to receive DRL_RI, RTX-US, or RTX-EU on days 1 and 15. The primary PK end points included area under the concentration-time curve from time 0 to 336 h after first infusion (AUC 0-14 days, first infusion ), AUC from day 1 through week 16 (AUC 0-∞, entire course ), and AUC from time 0 to time of last quantifiable concentration after the second dose (AUC 0-t, second infusion ). Secondary end points included other PK parameters, such as maximum concentration (C max ), time to C max  after each infusion, terminal half-life, systemic clearance, and volume of distribution after the second infusion; PD parameters and efficacy until week 24; safety and immunogenicity at week 24 and 52; and B cell recovery until week 52. AUC from time 0 to time of last quantifiable concentration after the first dose and over the entire course from day 1 through week 16 (AUC 0-t, entire course ) was analyzed as an exploratory end point.
RESULTS


The 91% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the primary end point of AUC 0-∞, entire course  were within the bioequivalence limits of 80-125% for all comparisons: DRL_RI versus RTX-US 100.37% (92.30-109.14), DRL_RI versus RTX-EU 93.58% (85.98-101.85), and RTX-US versus RTX-EU 93.24% (85.62-101.54). PD outcomes (peripheral blood B-cell depletion and mean change in Disease Activity Score [28 joints]-C-reactive protein), efficacy, safety, and immunogenicity were also comparable between DRL_RI and the reference products.
CONCLUSION


DRL_RI, a proposed biosimilar, demonstrated three-way PK similarity with RTX-EU and RTX-US, the reference innovator products, with comparable efficacy, PD, safety, and immunogenicity.
CLINICAL TRIALS REGISTRATION NUMBER


ClinicalTrials.gov identifier: NCT02296775.",2020,"The 91% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the primary end point of AUC 0-∞, entire course  were within the bioequivalence limits of 80-125% for all comparisons: DRL_RI versus RTX-US 100.37% (92.30-109.14), DRL_RI versus RTX-EU 93.58% (85.98-101.85), and RTX-US versus RTX-EU 93.24% (85.62-101.54).","['276 patients with moderate-to-severe active RA', 'rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX)-based therapy and no prior biologic administration', 'Biologics-Naïve Patients with Moderate-to-Severe Rheumatoid Arthritis']","['DRL_RI Versus Reference Rituximab', 'DRL_RI, RTX-US, or RTX-EU']","['mean change in Disease Activity Score [28\xa0joints]-C-reactive protein), efficacy, safety, and immunogenicity', 'Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity', 'PK parameters, such as maximum concentration (C max ), time to C max  after each infusion, terminal half-life, systemic clearance, and volume of distribution after the second infusion; PD parameters and efficacy until week 24; safety and immunogenicity', 'efficacy, PD, safety, and immunogenicity', 'PD outcomes (peripheral blood B-cell depletion and', 'geometric mean ratios (GMRs', 'pharmacodynamics (PD), efficacy, safety, and immunogenicity', 'area under the concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",276.0,0.255532,"The 91% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the primary end point of AUC 0-∞, entire course  were within the bioequivalence limits of 80-125% for all comparisons: DRL_RI versus RTX-US 100.37% (92.30-109.14), DRL_RI versus RTX-EU 93.58% (85.98-101.85), and RTX-US versus RTX-EU 93.24% (85.62-101.54).","[{'ForeName': 'Vikram Muralidhar', 'Initials': 'VM', 'LastName': 'Haridas', 'Affiliation': 'Sushruta Multispeciality Hospital, Hubballi, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Katta', 'Affiliation': 'Katta Hospital, S.R. Kalla Memorial General Hospital, Jaipur, India.'}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Nalawade', 'Affiliation': 'Inamdar Multispecialty Hospital, Pune, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Kharkar', 'Affiliation': 'Govt Medical College and Hospital, Medical Square, Nagpur, India.'}, {'ForeName': 'Vyacheslav', 'Initials': 'V', 'LastName': 'Zhdan', 'Affiliation': 'M.V.Sklifosovskyi Poltava Regional Hospital, Poltava, Ukraine.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Garmish', 'Affiliation': 'SI NSC M.D. Strazhesko Institute of Cardiology, NAMS of Ukraine, Kiev, Ukraine.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Lopez-Lazaro', 'Affiliation': ""Clinical Sciences, Dr. Reddy's Laboratories Ltd., Elisabethenanlage 11, 4051, Basel, Switzerland. llopezlazaro@drreddys.com.""}, {'ForeName': 'Sonica Sachdeva', 'Initials': 'SS', 'LastName': 'Batra', 'Affiliation': ""Medical Sciences, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad, 500090, India.""}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Kankanwadi', 'Affiliation': ""Development, Biologics, Dr. Reddy's Laboratories Ltd., Elisabethenanlage 11, 4051, Basel, Switzerland.""}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00406-1']
273,31795035,Stability of frontal alpha asymmetry in depressed patients during antidepressant treatment.,"INTRODUCTION


Frontal alpha asymmetry (FAA) is a proposed prognostic biomarker in major depressive disorder (MDD), conventionally acquired with electroencephalography (EEG). Although small studies attributed trait-like properties to FAA, a larger sample is needed to reliably asses this characteristic. Furthermore, to use FAA to predict treatment response, determining its stability, including the potential dependency on depressive state or medication, is essential.
METHODS


In the international Study to Predict Optimized Treatment in Depression (iSPOT-D), a multi-center, randomized, prospective open-label trial, 1008 MDD participants were randomized to treatment with escitalopram, sertraline or venlafaxine-extended release. Treatment response was established eight weeks after treatment initiation and resting state EEG was measured both at baseline and after eight weeks (n = 453).
RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity. After randomizing females to escitalopram or sertraline, for whom treatment response could be predicted in an earlier study, FAA after eight weeks resulted in equivalent response prediction as baseline FAA (one tailed p = .028).
CONCLUSION


We demonstrate that FAA is a stable trait, robust to time, state and pharmacological status. This confirms FAA stability. Furthermore, as prediction of treatment response is irrespective of moment of measurement and use of medication, FAA can be used as a state-invariant prognostic biomarker with promise to optimize MDD treatments.",2019,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","['1008 MDD participants', 'depressed patients during antidepressant treatment']","['escitalopram, sertraline or venlafaxine-extended release', 'FAA', 'Frontal alpha asymmetry (FAA', 'sertraline']","['resting state EEG', 'Stability of frontal alpha asymmetry']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]",1008.0,0.02721,"RESULTS


FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","[{'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'van der Vinne', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Synaeda Psycho Medisch Centrum, Leeuwarden, The Netherlands; Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands. Electronic address: n.van.der.vinne@synaeda.nl.'}, {'ForeName': 'Madelon A', 'Initials': 'MA', 'LastName': 'Vollebregt', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Michel J A M', 'Initials': 'MJAM', 'LastName': 'van Putten', 'Affiliation': 'Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands; Department of Clinical Neurophysiology and Neurology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102056']
274,30329163,5-aminolaevulinic acid nanoemulsion is more effective than methyl-5-aminolaevulinate in daylight photodynamic therapy for actinic keratosis: a nonsponsored randomized double-blind multicentre trial.,"BACKGROUND


Daylight photodynamic therapy (DL-PDT) with methyl-5-aminolaevulinate (MAL) is an effective treatment for mild and moderate actinic keratosis (AK).
OBJECTIVES


To assess the clinical efficacy, tolerability and cost-effectiveness of 5-aminolaevulinic acid nanoemulsion (BF-200 ALA) compared with MAL in DL-PDT for grade I-II AKs.
METHODS


This nonsponsored, prospective randomized double-blind multicentre trial included 69 patients with 767 grade I-II AKs located symmetrically on the face or scalp. A single DL-PDT was given in a randomized split-face design. The primary outcome was clearance of the AKs at 12 months as assessed by a blinded observer. The secondary outcomes were pain, treatment reactions, cosmetic outcome and the cost-effectiveness of the therapy.
RESULTS


In the per-patient (half-face) analysis, clearance was better for the BF-200 ALA sides than for those treated with MAL (P = 0·008). In total, BF-200 ALA cleared 299/375 AKs (79·7%) and MAL 288/392 (73·5%) (P = 0·041). The treatment was practically painless with both photosensitizers, the mean pain visual analogue scale being 1·51 for BF-200 ALA and 1·35 for MAL (P = 0·061). Twenty-six patients had a stronger skin reaction on the BF-200 ALA side, seven on the MAL side and 23 displayed no difference (P = 0·001). The cosmetic outcome was excellent or good in > 90% of cases with both photosensitizers (P = 1·000). The cost-effectiveness plane showed that the costs of DL-PDT were similar for both photosensitizers, but the effectiveness was slightly higher for BF-200 ALA.
CONCLUSIONS


Our results indicate that BF-200 ALA is more effective than MAL in DL-PDT for grade I-II AKs. BF-200 ALA provides slightly better value for money than MAL.",2019,"The treatment was practically painless with both photosensitizers, the mean pain visual analogue scale being 1·51 for BF-200 ALA and 1·35 for MAL (P = 0·061).","['mild and moderate actinic keratosis (AK', '69 patients with 767 grade', 'actinic keratosis']","['MAL', 'Daylight photodynamic therapy (DL-PDT) with methyl-5-aminolaevulinate (MAL', 'ALA', 'BF-200', '5-aminolaevulinic acid nanoemulsion', '5-aminolaevulinic acid nanoemulsion (BF-200 ALA', 'BF-200 ALA']","['clinical efficacy, tolerability and cost-effectiveness', 'pain, treatment reactions, cosmetic outcome and the cost-effectiveness of the therapy', 'stronger skin reaction', 'cost-effectiveness plane', 'mean pain visual analogue scale', 'clearance of the AKs', 'cosmetic outcome', 'costs of DL-PDT']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0600157', 'cui_str': 'Aminolevulinate'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C3490787', 'cui_str': 'BF-200 ALA'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0044588', 'cui_str': 'PDT'}]",69.0,0.310055,"The treatment was practically painless with both photosensitizers, the mean pain visual analogue scale being 1·51 for BF-200 ALA and 1·35 for MAL (P = 0·061).","[{'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Räsänen', 'Affiliation': 'Department of Dermatology, Joint Authority for Päijät-Häme Health and Wellbeing, Lahti, Finland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Neittaanmäki', 'Affiliation': 'Departments of Pathology and Dermatology, Institutes of Biomedicine and Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ylitalo', 'Affiliation': 'Department of Dermatology, Faculty of Medicine and Life Sciences, Tampere University Hospital and University of Tampere, Tampere, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hagman', 'Affiliation': 'Department of Dermatology, Vaasa Central Hospital, Vaasa, Finland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rissanen', 'Affiliation': 'Faculty of Social Sciences (Health Sciences), University of Tampere, Tampere, Finland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ylianttila', 'Affiliation': 'Radiation and Nuclear Safety Authority of Finland (STUK), Helsinki, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Salmivuori', 'Affiliation': 'Department of Dermatology, Joint Authority for Päijät-Häme Health and Wellbeing, Lahti, Finland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Snellman', 'Affiliation': 'Department of Dermatology, Faculty of Medicine and Life Sciences, Tampere University Hospital and University of Tampere, Tampere, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Grönroos', 'Affiliation': 'Department of Dermatology, Joint Authority for Päijät-Häme Health and Wellbeing, Lahti, Finland.'}]",The British journal of dermatology,['10.1111/bjd.17311']
275,32205642,"Optimal Timing of Feeding After Endoscopic Hemostasis in Patients With Peptic Ulcer Bleeding: A Randomized, Noninferiority Trial (CRIS KCT0001019).","OBJECTIVES


The optimal duration of fasting after endoscopic hemostasis in patients with peptic ulcer bleeding has not yet been determined. We investigated the appropriate timing of feeding after endoscopic hemostasis in patients with high-risk peptic ulcer bleeding.
METHODS


This study was a randomized, single center, noninferiority trial. Between February 2014 and March 2019, consecutive patients with peptic ulcer bleeding were randomized to resume feeding either 24 or 48 hours after successful endoscopic hemostasis. A total of 209 eligible patients were included in the intention-to-treat analysis and 200 in the per-protocol (PP) analysis. The primary outcome measure was recurrent bleeding within 7 days of hemostasis. Noninferiority testing was performed in the PP population, and the noninferiority margin was set at 10%. Secondary outcomes included 30-day rebleeding and mortality, transfusion requirements, and length of hospital stay.
RESULTS


Recurrent bleeding rates at 7 days were 7.9% in the 24-hour group and 4.0% in the 48-hour group in the PP analysis; tests for noninferiority did not reach statistical significance (difference: 3.9%, 95% confidence interval [CI]: -2.7 to 10.5, P value for noninferiority = 0.034). The recurrent bleeding rates within 30 days were 10.9% and 4.0% in the 24- and 48-hour groups (difference: 6.9%, 95% CI: -0.5 to 14.2), and the 30-day mortality rates were 5.9% and 14.1%, respectively (difference: -8.2%, 95% CI: -16.5 to 0.1) in the PP analysis. The transfusion requirement and the length of hospital stay were similar between the 2 groups.
DISCUSSION


Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding. Our results do not allow a recommendation of refeeding at 24 hours, rather than later refeeding in this population.",2020,Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding.,"['209 eligible patients were included in the intention-to-treat analysis and 200 in the per-protocol (PP) analysis', 'patients with peptic ulcer bleeding', 'Between February 2014 and March 2019, consecutive patients with peptic ulcer bleeding', 'patients with high-risk peptic ulcer bleeding', 'Patients With Peptic Ulcer Bleeding']",[],"['transfusion requirement and the length of hospital stay', 'Recurrent bleeding rates', '30-day mortality rates', '30-day rebleeding and mortality, transfusion requirements, and length of hospital stay', 'recurrent bleeding within 7 days of hemostasis', 'recurrent bleeding rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030920', 'cui_str': 'Gastroduodenal Ulcer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]",[],"[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",209.0,0.218447,Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding.,"[{'ForeName': 'Eun Jeong', 'Initials': 'EJ', 'LastName': 'Gong', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Sang Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Baek Gyu', 'Initials': 'BG', 'LastName': 'Jun', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Hyun Il', 'Initials': 'HI', 'LastName': 'Seo', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Jong Kyu', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Koon Hee', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Young Don', 'Initials': 'YD', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Gab Jin', 'Initials': 'GJ', 'LastName': 'Cheon', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Seo Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Korea.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000584']
276,31939063,"Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial.","OBJECTIVE


Our objective was to evaluate the long-term efficacy, safety, and immunogenicity of the infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX), in patients with rheumatoid arthritis (RA) who continued biosimilar treatment throughout 78 weeks or who switched from reference infliximab (Remicade ® ) sourced from the EU (IFX-EU) at week 30 or week 54 in the REFLECTIONS B537-02 study.
METHODS


In this phase III, double-blind, active-controlled study, patients with moderate-to-severe active RA were initially randomized to PF-SZ-IFX or IFX-EU, each with methotrexate (treatment period [TP] 1; N = 650). At week 30, patients receiving PF-SZ-IFX continued PF-SZ-IFX; patients receiving IFX-EU were re-randomized to continue IFX-EU or switch to PF-SZ-IFX (TP2; n = 566). From weeks 54 to 78, all patients received open-label treatment with PF-SZ-IFX (TP3; n = 505). Efficacy, safety, and immunogenicity data were analyzed during TP3.
RESULTS


Efficacy was sustained and comparable across groups at week 78, with American College of Rheumatology criteria for ≥ 20% clinical improvement response rates of 75.9% (biosimilar group), 77.8% (week 30 switch group), and 68.3% (week 54 switch group). The incidence of treatment-emergent adverse events was 28.9%, 29.4%, and 30.2%, respectively. The proportion of patients who were antidrug antibody (ADA) positive and neutralizing antibody positive (as a percentage of ADA-positive patients) was stable and comparable between groups.
CONCLUSIONS


Results to week 78 continue to support the efficacy, safety, and immunogenicity of PF-SZ-IFX in patients with moderate-to-severe active RA. There were no clinically meaningful differences between groups, independent of a single treatment transition from IFX-EU to PF-SZ-IFX at week 30 or week 54.
TRIAL REGISTRATION NUMBER


NCT02222493.",2020,"Efficacy was sustained and comparable across groups at week 78, with American College of Rheumatology criteria for ≥ 20% clinical improvement response rates of 75.9% (biosimilar group), 77.8% (week 30 switch group), and 68.3% (week 54 switch group).","['patients with moderate-to-severe active RA', 'patients with rheumatoid arthritis (RA) who continued biosimilar treatment throughout 78\xa0weeks or who switched from reference infliximab (Remicade ® ) sourced from the EU (IFX-EU) at week 30 or week 54 in the REFLECTIONS B537-02 study', 'Patients with Rheumatoid Arthritis']","['PF-SZ-IFX or IFX-EU, each with methotrexate', 'infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX', 'Infliximab (IFX', 'open-label treatment with PF-SZ-IFX (TP3']","['efficacy, safety, and immunogenicity', 'incidence of treatment-emergent adverse events', 'Efficacy', 'Efficacy, safety, and immunogenicity data', 'long-term efficacy, safety, and immunogenicity', 'antidrug antibody (ADA) positive and neutralizing antibody positive']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0723012', 'cui_str': 'Remicade'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0075032', 'cui_str': 'TP3'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C1609515', 'cui_str': 'Neutralising antibodies positive'}]",650.0,0.0748742,"Efficacy was sustained and comparable across groups at week 78, with American College of Rheumatology criteria for ≥ 20% clinical improvement response rates of 75.9% (biosimilar group), 77.8% (week 30 switch group), and 68.3% (week 54 switch group).","[{'ForeName': 'Stanley B', 'Initials': 'SB', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, TX, USA. arthdoc@aol.com.'}, {'ForeName': 'Sebastiao C', 'Initials': 'SC', 'LastName': 'Radominski', 'Affiliation': 'Universidade Federal do Paraná, Rua General Carneiro, 181-Alto Da Glória, Curitiba, PR, 80060-900, Brazil.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Toho University, 2-22-36, Ohashi Meguro-ku, Tokyo, 153-8515, Japan.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tee', 'Affiliation': 'Department of Medicine, Medical Center Manila, University of the Philippines, Manila, Philippines.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Cronenberger', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, La Jolla, CA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hackley', 'Affiliation': 'Pfizer R&D UK, Ltd, Sandwich, Kent, UK.'}, {'ForeName': 'Muhammad I', 'Initials': 'MI', 'LastName': 'Rehman', 'Affiliation': 'Pfizer Inc, Andover, MA, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'von Richter', 'Affiliation': 'Biopharmaceuticals, Hexal AG (a Sandoz company), Holzkirchen, Germany.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'Alten', 'Affiliation': 'Schlosspark-Klinik University Medicine, Heubnerweg 2, 14059, Berlin, Germany.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-019-00403-z']
277,31903654,An information-motivation-behavioural-based model and adherence to inhalation therapy and other health outcomes in patients with chronic obstructive pulmonary disease: A pilot randomized controlled trial.,"AIMS


To explore the feasibility and effects of the programme based on information-motivation-behavioural skills (IMB) model (IMB programme) on adherence to inhalation therapy and other health outcomes in chronic obstructive pulmonary disease (COPD) patients.
BACKGROUND


Poor adherence to inhalation therapy is common among COPD patients. The IMB model is supported by previous studies as useful in promoting adherence to health behaviours.
METHODS


This pilot randomized controlled trial randomized 35 COPD patients to receive either the IMB-based programme or usual care. The 4-week IMB programme consisted of a face-to-face and two telephone sessions to empower patients with skills and knowledge on using inhalation therapy and support their goal attainment for treatment compliance. Outcome evaluation including adherence to inhalation therapy, inhalation techniques, disease impact, and quality of life was conducted at baseline and at 6 weeks after randomization. Feasibility of the IMB programme was evaluated by a satisfaction survey and implementation experience.
RESULTS


Thirty patients completed the study, with an attrition rate of 14.3%. The intervention group (n = 15) had significant improvements in inhalation adherence, inhalation techniques, and quality of life than the control group over the evaluation period. Patient satisfaction survey results and observations on programme implementation suggested the feasibility of the IMB programme.
CONCLUSION


A IMB model is a feasible and potentially effective intervention for improving COPD patients' adherence to inhalation therapy.",2020,"The intervention group (n = 15) had significant improvements in inhalation adherence, inhalation techniques, and quality of life than the control group over the evaluation period.","['35 COPD patients', 'patients with chronic obstructive pulmonary disease', 'Thirty patients completed the study, with an attrition rate of 14.3', 'chronic obstructive pulmonary disease (COPD) patients', 'COPD patients']","['programme based on information-motivation-behavioural skills (IMB) model (IMB programme', 'IMB programme consisted of a face-to-face and two telephone sessions', 'IMB programme', 'IMB-based programme or usual care']","['inhalation adherence, inhalation techniques, and quality of life', 'adherence to inhalation therapy, inhalation techniques, disease impact, and quality of life']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0021459', 'cui_str': 'Inhalation Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",35.0,0.0474825,"The intervention group (n = 15) had significant improvements in inhalation adherence, inhalation techniques, and quality of life than the control group over the evaluation period.","[{'ForeName': 'Ka Wing', 'Initials': 'KW', 'LastName': 'To', 'Affiliation': 'Hong Kong Baptist Hospital, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Iris Fung-Kam', 'Initials': 'IF', 'LastName': 'Lee', 'Affiliation': 'Nethersole Institute of Continuing Holistic Health, School of Nursing, Faculty of Medicine, The University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'Nethersole Institute of Continuing Holistic Health, School of Nursing, Faculty of Medicine, The University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Yannes Tsz Yan', 'Initials': 'YTY', 'LastName': 'Cheung', 'Affiliation': 'Nethersole Institute of Continuing Holistic Health, School of Nursing, Faculty of Medicine, The University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Doris Sau-Fung', 'Initials': 'DS', 'LastName': 'Yu', 'Affiliation': 'Nethersole Institute of Continuing Holistic Health, School of Nursing, Faculty of Medicine, The University of Hong Kong, Shatin, Hong Kong.'}]",International journal of nursing practice,['10.1111/ijn.12799']
278,31985138,The effect of Health Belief Model-based health education programme on coping with premenstrual syndrome: a randomised controlled trial.,"AIM


The aim of this randomised controlled study was to determine the effect of Health Belief Model (HBM)-based health education programme in late adolescent period on coping with premenstrual syndrome (PMS).
METHODS


Thirty women both in the intervention and control groups were included. The HBM-based education programme was applied to cope with PMS. The intervention and control groups were followed up for three cycles in terms of PMS symptoms. The data were collected by a questionnaire and the Premenstrual Syndrome Scale.
RESULTS


There was a statistically significant difference between the pre-test mean scores and the first, second and third follow-up mean scores; and between the first follow-up mean score and the second and the third follow-up mean scores in the repeated measurements of the intervention group (p <.05). The mean scores of the intervention group were found to be significantly lower than the control group in the second and third follow-ups (p < .05).
CONCLUSION


In conclusion, HBM-based health education was effective for coping with PMS. It is recommended for dealing with PMS to use HBM-based education programmes, to motivate the students for life style changes, and to identify the obstacles and the benefits perceived about PMS.",2020,"There was a statistically significant difference between the pre-test mean scores and the first, second and third follow-up mean scores; and between the first follow-up mean score and the second and the third follow-up mean scores in the repeated measurements of the intervention group (p <.05).","['late adolescent period on coping with premenstrual syndrome (PMS', 'coping with premenstrual syndrome', 'Thirty women both in the intervention and control groups were included']","['Health Belief Model (HBM)-based health education programme', 'Health Belief Model-based health education programme']","['mean scores', 'Premenstrual Syndrome Scale']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018701'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0222045'}]",30.0,0.0265989,"There was a statistically significant difference between the pre-test mean scores and the first, second and third follow-up mean scores; and between the first follow-up mean score and the second and the third follow-up mean scores in the repeated measurements of the intervention group (p <.05).","[{'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Ayaz-Alkaya', 'Affiliation': 'Faculty of Health Sciences, Department of Nursing, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Şengül', 'Initials': 'Ş', 'LastName': 'Yaman-Sözbir', 'Affiliation': 'Faculty of Health Sciences, Department of Nursing, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Terzi', 'Affiliation': 'Fazıl Boyner Faculty of Health Sciences, Department of Nursing, Kastamonu University, Kastamonu, Turkey.'}]",International journal of nursing practice,['10.1111/ijn.12816']
279,30951589,Physical Activity Intentions and Behavior Mediate Treatment Response in an Acceptance-Based Weight Loss Intervention.,"BACKGROUND


Acceptance-based treatment (ABT) for weight loss has shown promise for improving outcomes relative to standard behavioral treatment (SBT). One way in which ABT may improve outcomes is through increasing physical activity (PA) intentions and behavior but little research has examined these as mediators of ABT on weight change.
PURPOSE


This study sought to examine ABT's effects on intentions for PA and several objectively measured PA variables during treatment and analyze PA intentions and behaviors as mediators of ABT's effect on weight loss.
METHODS


Participants (N = 189) with overweight/obesity randomized to 1 year of either ABT or SBT completed ecological momentary assessment of PA intentions, accelerometer-based PA assessment, and had weight measured at baseline, mid-treatment, and end of treatment.
RESULTS


ABT had a significantly higher increase than SBT in PA intention minutes at mid-treatment and end of treatment (p < 0.001), and both groups had nonlinear increases in moderate-to-vigorous physical activity (MVPA) that were not significantly different. Sequential mediation models found that ABT's effect on weight loss was partially mediated by higher PA intention minutes at mid-treatment leading to increased MVPA minutes per week. Increased MVPA minutes were obtained by participants increasing the number of days with MVPA bouts.
CONCLUSIONS


ABT's effect on weight loss throughout treatment resulted, in part, from participants increasing their intentions for PA. Controlling for group, higher PA intentions were associated with more PA obtained through more days with exercise.",2019,"RESULTS


ABT had a significantly higher increase than SBT in PA intention minutes at mid-treatment and end of treatment (p < 0.001), and both groups had nonlinear increases in moderate-to-vigorous physical activity (MVPA) that were not significantly different.","['Participants (N = 189) with overweight/obesity randomized to 1 year of either ABT or SBT completed ecological momentary assessment of PA intentions, accelerometer-based PA assessment, and had weight measured at baseline, mid-treatment, and end of treatment']",[],"['Increased MVPA minutes', 'weight loss', 'moderate-to-vigorous physical activity (MVPA', 'SBT in PA intention minutes']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]",[],"[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",189.0,0.0520204,"RESULTS


ABT had a significantly higher increase than SBT in PA intention minutes at mid-treatment and end of treatment (p < 0.001), and both groups had nonlinear increases in moderate-to-vigorous physical activity (MVPA) that were not significantly different.","[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Schumacher', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital/Brown Alpert Medical School, Providence, RI, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science (WELL Center), Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science (WELL Center), Drexel University, Philadelphia, PA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz011']
280,32244495,"Entrepreneurial, Economic, and Social Well-Being Outcomes from an RCT of a Youth Entrepreneurship Education Intervention among Native American Adolescents.","Background:  Entrepreneurship education has demonstrated positive impacts in low-resource contexts. However, there is limited evidence of such programs evaluated among Native American (NA) youth in a rural reservation.  Methods:  A 2:1 randomized controlled trial evaluated the impact of the Arrowhead Business Group (ABG) entrepreneurship education program on entrepreneurship knowledge, economic empowerment, and social well-being among 394 NA youth. An intent to treat analysis using mixed effects regression models examined within and between study group differences from baseline to 24 months. An interaction term measured change in the intervention relative to change in the control. ABG participants were purposively sampled to conduct focus groups and in-depth interviews.  Results:  Significant intervention vs. control group improvements were sustained at 12 months for entrepreneurship knowledge and economic confidence/security. Significant within-group improvements were sustained for ABG participants at 24 months for connectedness to parents, school, and awareness of connectedness. Qualitative data endorses positive impacts on social well-being among ABG participants.  Conclusion:  Observed effects on entrepreneurship knowledge, economic empowerment, and connectedness, supplemented by the experiences and changes as described by the youth themselves, demonstrates how a strength-based youth entrepreneurship intervention focused on developing assets and resources may be an innovative approach to dually address health and economic disparities endured in Native American communities.",2020,Results:  Significant intervention vs. control group improvements were sustained at 12 months for entrepreneurship knowledge and economic confidence/security.,"['Native American Adolescents', '394 NA youth', 'ABG participants', 'Native American (NA) youth in a rural reservation']",['Arrowhead Business Group (ABG) entrepreneurship education program'],['entrepreneurship knowledge and economic confidence/security'],"[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}]","[{'cui': 'C0453107', 'cui_str': 'Arrowhead'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085116', 'cui_str': 'Entrepreneurship'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0085116', 'cui_str': 'Entrepreneurship'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.034813,Results:  Significant intervention vs. control group improvements were sustained at 12 months for entrepreneurship knowledge and economic confidence/security.,"[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Tingey', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 415 N. Washington St., Baltimore, MD 21231, USA.'}, {'ForeName': 'Francene', 'Initials': 'F', 'LastName': 'Larzelere', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Novalene', 'Initials': 'N', 'LastName': 'Goklish', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Rosenstock', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 415 N. Washington St., Baltimore, MD 21231, USA.'}, {'ForeName': 'Larissa Jennings', 'Initials': 'LJ', 'LastName': 'Mayo-Wilson', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 415 N. Washington St., Baltimore, MD 21231, USA.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Pablo', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Goklish', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Grass', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Feather', 'Initials': 'F', 'LastName': 'Sprengeler', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ingalls', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 415 N. Washington St., Baltimore, MD 21231, USA.'}, {'ForeName': 'Mariddie', 'Initials': 'M', 'LastName': 'Craig', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 308 Kuper St., Whiteriver, AZ 85941, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Barlow', 'Affiliation': 'Department of International Health, Johns Hopkins Center for American Indian Health, 415 N. Washington St., Baltimore, MD 21231, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17072383']
281,32215562,An Outreach Rehabilitation Program for Nursing Home Residents After Hip Fracture May Be Cost-Saving.,"BACKGROUND


We compared the cost-effectiveness of 10 weeks of outreach rehabilitation (intervention) versus usual care (control) for ambulatory nursing home residents after hip fracture.
METHODS


Enrollment occurred February 2011 through June 2015 in a Canadian metropolitan region. Seventy-seven participants were allocated in a 2:1 ratio to receive a 10-week rehabilitation program (intervention) or usual care (control) (46 intervention; 31 control). Using a payer perspective, we performed main and sensitivity analyses. Health outcome was measured by quality-adjusted life years (QALYs), using the EQ5D, completed at study entry, 3-, 6-, and 12-months. We obtained patient-specific data for outpatient visits, physician claims, and inpatient readmissions; the trial provided rehabilitation utilization/cost data. We estimated incremental cost and incremental effectiveness.
RESULTS


Groups were similar at study entry; the mean age was 87.9 ± 6.6 years, 54 (71%) were female and 58 (75%) had severe cognitive impairment. EQ5D QALYs scores were nonsignificantly higher for intervention participants. Inpatient readmissions were two times higher among controls, with a cost difference of -$3,350/patient for intervention participants, offsetting the cost/intervention participant of $2,300 for the outreach rehabilitation. The adjusted incremental QALYs/patient difference was 0.024 favoring the intervention, with an incremental cost/patient of -$621 for intervention participants; these values were not statistically significant. A sensitivity analysis reinforced these findings, suggesting that the intervention was likely dominant.
CONCLUSION


A 10-week outreach rehabilitation intervention for nursing home residents who sustain a hip fracture may be cost-saving, through reduced postfracture hospital readmissions. These results support further work to evaluate postfracture rehabilitation for nursing home residents.",2020,"Inpatient re-admissions were two times higher among controls, with a cost difference of -$3350/patient for intervention participants, offsetting the cost/intervention participant of $2300 for the outreach rehabilitation.","['nursing home residents', 'Groups were similar at study entry; the mean age was 87.9±6.6 years, 54(71%) were female and 58(75%) had severe cognitive impairment', 'ambulatory nursing home residents after hip fracture', 'Nursing Home Residents after Hip Fracture', '77 participants', 'Enrollment occurred February 2011 through June 2015 in a Canadian metropolitan region']","['outreach rehabilitation (intervention) versus usual care (control', 'outreach rehabilitation intervention', '10-week rehabilitation program (intervention) or usual care (control']","['EQ5D QALYs scores', 'incremental cost and incremental effectiveness']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",77.0,0.0266942,"Inpatient re-admissions were two times higher among controls, with a cost difference of -$3350/patient for intervention participants, offsetting the cost/intervention participant of $2300 for the outreach rehabilitation.","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Beaupre', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Lier', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Magaziner', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'C Allyson', 'Initials': 'CA', 'LastName': 'Jones', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'D William C', 'Initials': 'DWC', 'LastName': 'Johnston', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Sumit R', 'Initials': 'SR', 'LastName': 'Majumdar', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, Canada.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa074']
282,32081787,Analysis of the Whole CDR3 T Cell Receptor Repertoire after Hematopoietic Stem Cell Transplantation in 2 Clinical Cohorts.,"A major cause of morbidity and mortality for patients who undergo hematologic stem cell transplantation (HSCT) is acute graft-versus-host disease (aGVHD), a mostly T cell-mediated disease. Examination of the T cell receptor (TCR) repertoire of HSCT recipients and the use of next-generation nucleotide sequencing have raised the question of whether features of TCR repertoire reconstitution might reproducibly associate with aGVHD. We hypothesized that the peripheral blood TCR repertoire of patients with steroid-nonresponsive aGVHD would be less diverse. We also hypothesized that patients with GVHD who shared HLA might also share common clones at the time of GVHD diagnosis, thereby potentially providing potential clinical indicators for treatment stratification. We further hypothesized that HSCT recipients with the same HLA mismatch might share a more similar TCR repertoire based on a potentially shared focus of alloreactive responses. We studied 2 separate patient cohorts and 2 separate platforms for measuring TCR repertoire. The first cohort of patients was from a multicenter Phase III randomized double-blinded clinical trial of patients who developed aGVHD (NCT01002742). The second cohort comprised samples from biobanks from 2 transplantation centers and the Center for International Blood and Marrow Transplant Research of patients who underwent mismatched HSCT. There were no statistically significant differences in the TCR diversity of steroid responders and nonresponders among patients with aGVHD on the day of diagnosis. Most clones in the repertoire were unique to each patient, but a small number of clones were found to be both exclusive to and shared among aGVHD nonresponders. We were also able to show a strong correlation between the presence of Vβ20 and Vβ29 and steroid responsiveness. Using the Bhattacharya coefficient, those patients who shared the same HLA mismatch were shown to be no more similar to one another than to those who had a completely different mismatch. Using 2 separate clinical cohorts and 2 separate platforms for analyzing the TCR repertoire, we have shown that the sampled human TCR repertoire is largely unique to each patient but contains glimmers of common clones of subsets of clones based on responsiveness to steroids in aGVHD on the day of diagnosis. These studies are informative for future strategies to assess for reproducible TCR responses in human alloreactivity and possible markers of GVHD responsiveness to therapy.",2020,There were no statistically significant differences in the TCR diversity of steroid responders and non-responders among patients with acute GVHD on the day of diagnosis.,"['patients with steroid non-responsive, acute GVHD', 'patients with GVHD', 'patients who undergo hematological stem cell transplantations (HSCT']",['HSCT'],"['TCR diversity of steroid responders', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]",[],"[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0473044,There were no statistically significant differences in the TCR diversity of steroid responders and non-responders among patients with acute GVHD on the day of diagnosis.,"[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Shah', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Tamaresis', 'Affiliation': 'Department of Biomedical Data Science, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Laura Jean', 'Initials': 'LJ', 'LastName': 'Kenyon', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Krish', 'Initials': 'K', 'LastName': 'Rangarajan', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Spellman', 'Affiliation': 'National Marrow Donor Program/C Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nikiforow', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Zehnder', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Everett H', 'Initials': 'EH', 'LastName': 'Meyer', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University School of Medicine, Stanford, California. Electronic address: evmeyer@stanford.edu.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.01.020']
283,31431654,Lack of social support as measured by the Family Resource Scale screening tool is associated with early adverse cognitive outcome in extremely low birth weight children.,"OBJECTIVE


Extremely low birth weight children are at high risk for cognitive impairment.
STUDY DESIGN


Cognitive outcome of extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed. Family resources and social support were assessed using a Family Resource Scale parent questionnaire. Regression analysis was used to determine independent demographic, medical, and family resource factors influencing longitudinal cognitive outcome.
RESULT


Higher Family Resource Scale scores at 18 months were associated with greater improvement in cognitive scores between 18 and 30 months. Cognitive outcome was most adversely affected in children whose families had the least resources and social support. The adverse effect of poor social support was independent of family income.
CONCLUSION


Poor interpersonal social support has an independent, adverse impact on cognitive outcomes of extremely low birth weight infants.",2019,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"['extremely low birth weight infants', 'extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed', 'extremely low birth weight children']",[],"['Cognitive outcome', 'Higher Family Resource Scale scores', 'cognitive scores']","[{'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0599714,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Fuller', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA. mfuller@sandiego.edu.'}, {'ForeName': 'Yvonne E', 'Initials': 'YE', 'LastName': 'Vaucher', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': 'Department of Pediatrics, Women, and Infants Hospital, Brown University, Providence, RI, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0462-2']
284,32240143,[Cerebral protection from ischaemia during carotid endarterectomy].,"The purpose of this study was to assess efficacy of cerebral protection during carotid endarterectomy by means of controlled systemic hypertension in patients presenting with various levels of retrograde pressure in the internal carotid artery. The study enrolled a total of 150 patients subjected to carotid endarterectomy. The operation was carried out under general anaesthesia with artificial pulmonary ventilation and was accompanied by haemodynamic monitoring with invasive control of arterial pressure, as well as primary and additional correction of central haemodynamics. Cerebral perfusion was assessed by measuring retrograde pressure in the internal carotid artery. The retrograde pressure index was calculated, according to which the patients were subdivided into three groups: those with values less than 30, with values from 30 to 39, and with values of 40 and more. Controlled systemic arterial hypertension was used as cerebral protection during the period of cross-clamping of the internal carotid artery, with phenylephrine and norepinephrine administered for this purpose. The parameters of central haemodynamics, time intervals of the operation, and the duration of internal carotid artery cross-clamping in the groups did not statistically differ (p>0.05). A statistically significant difference was revealed in the level of systolic arterial pressure necessary for cerebral protection (p<0.05). There were no cerebral circulation impairments, myocardial infarctions, nor lethal outcomes. A conclusion was drawn that individualized correction of central haemodynamics ensured a sufficient level of collateral compensation of the cerebral blood flow, thus making it possible to refuse from using intraluminal shunts.",2020,A statistically significant difference was revealed in the level of systolic arterial pressure necessary for cerebral protection (p<0.05).,"['patients presenting with various levels of retrograde pressure in the internal carotid artery', '150 patients subjected to carotid endarterectomy']","['phenylephrine and norepinephrine', 'carotid endarterectomy']","['central haemodynamics, time intervals of the operation, and the duration of internal carotid artery cross-clamping', 'level of systolic arterial pressure necessary for cerebral protection', 'Cerebral perfusion', 'retrograde pressure index', 'cerebral circulation impairments, myocardial infarctions, nor lethal outcomes', 'retrograde pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",150.0,0.0286165,A statistically significant difference was revealed in the level of systolic arterial pressure necessary for cerebral protection (p<0.05).,"[{'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Vachev', 'Affiliation': 'Department of Faculty Surgery, Samara State Medical University of the RF Ministry of Public Health, Samara, Russia.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Prozhoga', 'Affiliation': 'Department of Faculty Surgery, Samara State Medical University of the RF Ministry of Public Health, Samara, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Dmitriev', 'Affiliation': 'Department of Faculty Surgery, Samara State Medical University of the RF Ministry of Public Health, Samara, Russia.'}]",Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery,['10.33529/ANGIO2020109']
285,32240141,[Autoarterial remodeling of the common carotid artery bifurcation in treatment of stenotic lesions].,"Carotid endarterectomy is the main operation carried out for prevention of ischaemic stroke in haemodynamically significant stenoses of the bifurcation of the common carotid artery. Despite the literature data demonstrating some advantages of eversion carotid endarterectomy over the classical technique there arises a series of complicated, as yet unsolved problems. This concerns the control of the distal portion of an atherosclerotic plaque in prolonged lesions of the internal carotid artery, the absence of a temporary bypass graft, necessity of prosthetic repair of the internal carotid artery in detachment of the distal border of the plaque. We suggested a new technique of carotid endarterectomy making it possible to widen visual removal of atheromatous masses from the internal carotid artery, to improve the control of the distal portion of the plaque in a prolonged lesion of the internal carotid artery. We carried out a comparative assessment of efficacy and safety of the new method of carotid endarterectomy versus the classical variant in a randomized study. The proposed technique of carotid endarterectomy turned out to be compatible by safety and demonstrated similar results with the classical carotid endarterectomy by the number of ischaemic strokes, transitory ischaemic attacks, and myocardial infarctions in the early and remote postoperative periods. When comparing the groups by efficiency, the primary efficacy endpoint, including cases of restenosis >50% according to the findings of ultrasonographic examination of the brachiocephalic arteries, all cases of ischaemic events (acute impairments of cerebral circulation, transitory ischaemic attacks), as well as the presence of the clinical picture of cranial nerve paresis demonstrated a significant advantage of the new technique versus the comparison group at the expense of a lower incidence of restenoses in the area of the operation during the whole period of follow up. In the group of autoarterial remodelling, the composite endpoint of outcomes occurred in 6 patients (6.1%) and in the group with the classic carotid endarterectomy - in 19 (19.6%) patients, p=0.005.",2020,"The proposed technique of carotid endarterectomy turned out to be compatible by safety and demonstrated similar results with the classical carotid endarterectomy by the number of ischaemic strokes, transitory ischaemic attacks, and myocardial infarctions in the early and remote postoperative periods.",['stenotic lesions'],"['Carotid endarterectomy', 'carotid endarterectomy']","['efficacy and safety', 'ischaemic events (acute impairments of cerebral circulation, transitory ischaemic attacks), as well as the presence of the clinical picture of cranial nerve paresis', 'ischaemic strokes, transitory ischaemic attacks, and myocardial infarctions']","[{'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0151311', 'cui_str': 'Cranial nerve paralysis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",,0.035114,"The proposed technique of carotid endarterectomy turned out to be compatible by safety and demonstrated similar results with the classical carotid endarterectomy by the number of ischaemic strokes, transitory ischaemic attacks, and myocardial infarctions in the early and remote postoperative periods.","[{'ForeName': 'P V', 'Initials': 'PV', 'LastName': 'Ignatenko', 'Affiliation': 'National Medical Research Centre named after Academician E.N. Meshalkin under the RF Ministry of Public Health, Novosibirsk, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Gostev', 'Affiliation': 'National Medical Research Centre named after Academician E.N. Meshalkin under the RF Ministry of Public Health, Novosibirsk, Russia.'}, {'ForeName': 'Sh B', 'Initials': 'SB', 'LastName': 'Saaia', 'Affiliation': 'National Medical Research Centre named after Academician E.N. Meshalkin under the RF Ministry of Public Health, Novosibirsk, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Rabtsun', 'Affiliation': 'National Medical Research Centre named after Academician E.N. Meshalkin under the RF Ministry of Public Health, Novosibirsk, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Cheban', 'Affiliation': 'National Medical Research Centre named after Academician E.N. Meshalkin under the RF Ministry of Public Health, Novosibirsk, Russia.'}, {'ForeName': 'V B', 'Initials': 'VB', 'LastName': 'Starodubtsev', 'Affiliation': 'National Medical Research Centre named after Academician E.N. Meshalkin under the RF Ministry of Public Health, Novosibirsk, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Karpenko', 'Affiliation': 'National Medical Research Centre named after Academician E.N. Meshalkin under the RF Ministry of Public Health, Novosibirsk, Russia.'}]",Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery,['10.33529/ANGIO2020117']
286,31087093,"""My Surgical Success"": Effect of a Digital Behavioral Pain Medicine Intervention on Time to Opioid Cessation After Breast Cancer Surgery-A Pilot Randomized Controlled Clinical Trial.","OBJECTIVE


This study aims to assess the feasibility of digital perioperative behavioral pain medicine intervention in breast cancer surgery and evaluate its impact on pain catastrophizing, pain, and opioid cessation after surgery.
DESIGN AND SETTING


A randomized controlled clinical trial was conducted at Stanford University (Palo Alto, CA, USA) comparing a digital behavioral pain medicine intervention (""My Surgical Success"" [MSS]) with digital general health education (HE).
PARTICIPANTS


A convenience sample of 127 participants were randomized to treatment group. The analytic sample was 68 patients (N = 36 MSS, N = 32 HE).
MAIN OUTCOMES


The primary outcome was feasibility and acceptability of a digital behavioral pain medicine intervention (80% threshold for acceptability items). Secondary outcomes were pain catastrophizing, past seven-day average pain intensity, and time to opioid cessation after surgery for patients who initiated opioid use.
RESULTS


The attrition rate for MSS intervention (44%) was notably higher than for HE controls (18%), but it was lower than typical attrition rates for e-health interventions (60-80%). Despite greater attrition for MSS, feasibility was demonstrated for the 56% of MSS engagers, and the 80% threshold for acceptability was met. We observed a floor effect for baseline pain catastrophizing, and no significant group differences were found for postsurgical pain catastrophizing or pain intensity. MSS was associated with 86% increased odds of opioid cessation within the 12-week study period relative to HE controls (hazard ratio = 1.86, 95% confidence interval = 1.12-3.10, P = 0.016).
CONCLUSIONS


Fifty-six percent of patients assigned to MSS engaged with the online platform and reported high satisfaction. MSS was associated with significantly accelerated opioid cessation after surgery (five-day difference) with no difference in pain report relative to controls. Perioperative digital behavioral pain medicine may be a low-cost, accessible adjunct that could promote opioid cessation after breast cancer surgery.",2019,"We observed a floor effect for baseline pain catastrophizing, and no significant group differences were found for postsurgical pain catastrophizing or pain intensity.","['A convenience sample of 127 participants', '68 patients (N\u2009=\u200936 MSS, N\u2009=\u200932 HE']","['digital behavioral pain medicine intervention (""My Surgical Success"" [MSS]) with digital general health education (HE', 'Digital Behavioral Pain Medicine Intervention', 'digital perioperative behavioral pain medicine intervention']","['postsurgical pain catastrophizing or pain intensity', 'pain catastrophizing, pain, and opioid cessation', 'feasibility and acceptability of a digital behavioral pain medicine intervention', 'pain catastrophizing, past seven-day average pain intensity, and time to opioid cessation', 'opioid cessation', 'attrition rate', 'accelerated opioid cessation', 'Time to Opioid Cessation']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018701'}]","[{'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",127.0,0.231884,"We observed a floor effect for baseline pain catastrophizing, and no significant group differences were found for postsurgical pain catastrophizing or pain intensity.","[{'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Darnall', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Maisa S', 'Initials': 'MS', 'LastName': 'Ziadni', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Parthasarathy', 'Initials': 'P', 'LastName': 'Krishnamurthy', 'Affiliation': 'Department of Marketing and Entrepreneurship, CT Bauer College of Business, University of Houston, Houston, Texas.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Flood', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Heathcote', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Mackey', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Chloe Jean', 'Initials': 'CJ', 'LastName': 'Taub', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, Florida.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Wheeler', 'Affiliation': 'Department of Surgery, Stanford University School of Medicine, Palo Alto, California, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz094']
287,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8']
288,32035020,"Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive breast cancer (FAKTION): a multicentre, randomised, controlled, phase 2 trial.","BACKGROUND


Capivasertib (AZD5363) is a potent selective oral inhibitor of all three isoforms of the serine/threonine kinase AKT. The FAKTION trial investigated whether the addition of capivasertib to fulvestrant improved progression-free survival in patients with aromatase inhibitor-resistant advanced breast cancer.
METHODS


In this randomised, double-blind, placebo-controlled, phase 2 trial, postmenopausal women aged at least 18 years with an Eastern Cooperative Oncology Group performance status of 0-2 and oestrogen receptor-positive, HER2-negative, metastatic or locally advanced inoperable breast cancer who had relapsed or progressed on an aromatase inhibitor were recruited from 19 hospitals in the UK. Enrolled participants were randomly assigned (1:1) to receive intramuscular fulvestrant 500 mg (day 1) every 28 days (plus a loading dose on day 15 of cycle 1) with either capivasertib 400 mg or matching placebo, orally twice daily on an intermittent weekly schedule of 4 days on and 3 days off (starting on cycle 1 day 15) until disease progression, unacceptable toxicity, loss to follow-up, or withdrawal of consent. Treatment allocation was done using an interactive web-response system using a minimisation method (with a 20% random element) and the following minimisation factors: measurable or non-measurable disease, primary or secondary aromatase inhibitor resistance, PIK3CA status, and PTEN status. The primary endpoint was progression-free survival with a one-sided alpha of 0·20. Analyses were done by intention to treat. Recruitment is complete, and the trial is in follow-up. This trial is registered with ClinicalTrials.gov, number NCT01992952.
FINDINGS


Between March 16, 2015, and March 6, 2018, 183 patients were screened for eligibility, of whom 140 (76%) were eligible and were randomly assigned to receive fulvestrant plus capivasertib (n=69) or fulvestrant plus placebo (n=71). Median follow-up for progression-free survival was 4·9 months (IQR 1·6-11·6). At the time of primary analysis for progression-free survival (Jan 30, 2019), 112 progression-free survival events had occurred, 49 (71%) in 69 patients in the capivasertib group compared with 63 (89%) of 71 in the placebo group. Median progression-free survival was 10·3 months (95% CI 5·0-13·2) in the capivasertib group versus 4·8 months (3·1-7·7) in the placebo group, giving an unadjusted hazard ratio (HR) of 0·58 (95% CI 0·39-0·84) in favour of the capivasertib group (two-sided p=0·0044; one-sided log rank test p=0·0018). The most common grade 3-4 adverse events were hypertension (22 [32%] of 69 patients in the capivasertib group vs 17 [24%] of 71 in the placebo group), diarrhoea (ten [14%] vs three [4%]), rash (14 [20%] vs 0), infection (four [6%] vs two [3%]), and fatigue (one [1%] vs three [4%]). Serious adverse reactions occurred only in the capivasertib group, and were acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting (one). One death, due to atypical pulmonary infection, was assessed as possibly related to capivasertib treatment. One further death in the capivasertib group had an unknown cause; all remaining deaths in both groups (19 in the capivasertib group and 31 in the placebo group) were disease related.
INTERPRETATION


Progression-free survival was significantly longer in participants who received capivasertib than in those who received placebo. The combination of capivasertib and fulvestrant warrants further investigation in phase 3 trials.
FUNDING


AstraZeneca and Cancer Research UK.",2020,"Serious adverse reactions occurred only in the capivasertib group, and were acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting (one).","['Between March 16, 2015, and March 6, 2018, 183 patients were screened for eligibility, of whom 140 (76%) were eligible', 'postmenopausal women aged at least 18 years with an Eastern Cooperative Oncology Group performance status of 0-2 and oestrogen receptor-positive, HER2-negative, metastatic or locally advanced inoperable breast cancer who had relapsed or progressed on an aromatase inhibitor were recruited from 19 hospitals in the UK', 'patients with aromatase inhibitor-resistant advanced breast cancer']","['Fulvestrant plus capivasertib versus placebo', 'capivasertib to fulvestrant', 'capivasertib 400 mg or matching placebo', 'capivasertib and fulvestrant', 'fulvestrant plus capivasertib (n=69) or fulvestrant plus placebo', 'Capivasertib (AZD5363', 'placebo', 'intramuscular fulvestrant']","['diarrhoea', '112 progression-free survival events', 'Median progression-free survival', 'acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting', 'Progression-free survival', 'rash', 'Serious adverse reactions', 'fatigue', 'infection', 'progression-free survival', 'Median follow-up for progression-free survival']","[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3502775', 'cui_str': 'AZD5363'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0041657', 'cui_str': 'Unconscious State'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",183.0,0.690338,"Serious adverse reactions occurred only in the capivasertib group, and were acute kidney injury (two), diarrhoea (three), rash (two), hyperglycaemia (one), loss of consciousness (one), sepsis (one), and vomiting (one).","[{'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Jones', 'Affiliation': 'Department of Cancer and Genetics, Cardiff University, Cardiff, UK; Velindre Cancer Centre, Cardiff, UK. Electronic address: robert.hugh.jones@wales.nhs.uk.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Casbard', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Carucci', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Cox', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Butler', 'Affiliation': 'All Wales Laboratory Genetics Service, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Alchami', 'Affiliation': 'Department of Cellular Pathology, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Tracie-Ann', 'Initials': 'TA', 'LastName': 'Madden', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bale', 'Affiliation': 'Betsi Cadwaladr University Health Board, Bangor, UK.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Bezecny', 'Affiliation': 'Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Joffe', 'Affiliation': 'Calderdale & Huddersfield NHS Foundation Trust, Huddersfield, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Moon', 'Affiliation': 'University Hospitals of Morecambe Bay NHS Foundation Trust, Lancaster, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Twelves', 'Affiliation': 'University of Leeds and Leeds Teaching Hospitals Trust, Leeds, UK.'}, {'ForeName': 'Ramachandran', 'Initials': 'R', 'LastName': 'Venkitaraman', 'Affiliation': 'The Ipswich Hospital NHS Trust, Ipswich, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Waters', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Foxley', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Sacha J', 'Initials': 'SJ', 'LastName': 'Howell', 'Affiliation': 'Division of Cancer Sciences, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30817-4']
289,31823620,Atomoxetine Efficacy in Methamphetamine Dependence during Methadone Maintenance Therapy.,"BACKGROUND


Co-occurring methamphetamine (METH) use during methadone maintenance therapy (MMT) is a highly prevalent and progressive problem in Iran. There are no registered pharmacological treatments for treating METH use disorder. The present study investigates the potential efficacy of atomoxetine in the treatment of these patients.
METHODS


In a double-blind, controlled clinical trial, 86 METH-dependents on MMT randomly received either atomoxetine (40 mg/d) or placebo. We measured the craving scores with visual analog scale (VAS) on a weekly basis, and evaluated depression, anxiety and stress with the Depression Anxiety Stress Scales (DASS) on a monthly basis. Measurements were made in each weekly visit with urinary METH drug test.
RESULTS


Atomoxetine significantly reduced METH craving (P < 0.001). Negative METH urine test increased significantly in the drug group compared to the placebo group (P = 0.007). While initially the METH urine test was positive for all patients, 56% (25/45) in the atomoxetine group and 26% (11/41) in the placebo group had negative METH urine tests after 8 weeks. DASS were decreased in both groups with a greater reduction in the atomoxetine group [depression (P = 0.028), anxiety (P = 0.038), and stress (P = 0.031)]. Only mild side effects were observed.
CONCLUSION


This study confirms the safety and clinical tolerance of atomoxetine, and its appropriate efficacy in suppressing METH craving and possible potential effects on its treatment.",2019,Negative METH urine test increased significantly in the drug group compared to the placebo group (P = 0.007).,[],"['methamphetamine (METH', 'atomoxetine', 'placebo', 'Atomoxetine', 'methadone maintenance therapy (MMT']","['METH craving', 'Negative METH urine test', 'DASS', 'craving scores with visual analog scale (VAS) on a weekly basis, and evaluated depression, anxiety and stress with the Depression Anxiety Stress Scales (DASS', 'anxiety', 'mild side effects', 'negative METH urine tests']",[],"[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0046370', 'cui_str': '2-methylcyclopentadienyl manganese tricarbonyl'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",86.0,0.240317,Negative METH urine test increased significantly in the drug group compared to the placebo group (P = 0.007).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rabiey', 'Affiliation': 'Department of Addiction Studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Hassani-Abharian', 'Affiliation': 'Institute for Cognitive Science Studies (IRICSS), Brain and Cognition Clinic, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Farhad', 'Affiliation': 'Department of Addiction Studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Moravveji', 'Affiliation': 'Department of Community Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Goodarz', 'Initials': 'G', 'LastName': 'Akasheh', 'Affiliation': 'Department of Psychiatry, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Banafshe', 'Affiliation': 'Department of Pharmacology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}]",Archives of Iranian medicine,[]
290,31685489,Effect of Surgical Versus Medical Therapy on Diabetic Kidney Disease Over 5 Years in Severely Obese Adolescents With Type 2 Diabetes.,"OBJECTIVE


To compare diabetic kidney disease (DKD) rates over 5 years of follow-up in two cohorts of severely obese adolescents with type 2 diabetes (T2D) undergoing medical or surgical treatment for T2D.
RESEARCH DESIGN AND METHODS


A secondary analysis was performed of data collected from obese participants of similar age and racial distribution enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) studies. Teen-LABS participants underwent metabolic bariatric surgery (MBS). TODAY participants were randomized to metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy given for glycemic progression. Glycemic control, BMI, estimated glomerular filtration rate (eGFR), urinary albumin excretion (UAE), and prevalence of hyperfiltration (eGFR ≥135 mL/min/1.73 m 2 ) and elevated UAE (≥30 mg/g) were assessed annually.
RESULTS


Participants with T2D from Teen-LABS ( n  = 30, mean ± SD age, 16.9 ± 1.3 years; 70% female; 60% white; BMI 54.4 ± 9.5 kg/m 2 ) and TODAY ( n  = 63, age 15.3 ± 1.3 years; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ) were compared. During 5 years of follow-up, hyperfiltration decreased from 21% to 18% in Teen-LABS and increased from 7% to 48% in TODAY. Elevated UAE decreased from 27% to 5% in Teen-LABS and increased from 21% to 43% in TODAY. Adjusting for baseline age, sex, BMI, and HbA 1c , TODAY participants had a greater odds of hyperfiltration (odds ratio 15.7 [95% CI 2.6, 94.3]) and elevated UAE (27.3 [4.9, 149.9]) at 5 years of follow-up.
CONCLUSIONS


Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.",2020,"Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.","['Participants with T2D from Teen-LABS ( n  = 30, mean ± SD age, 16.9 ± 1.3 years; 70% female; 60% white; BMI 54.4 ± 9.5 kg/m 2 ) and TODAY ( n  = 63, age 15.3 ± 1.3 years; 56% female; 71% white; BMI 40.5 ± 4.9 kg/m 2 ', 'Diabetic Kidney Disease Over 5 Years in Severely Obese Adolescents With Type 2 Diabetes', 'severely obese adolescents with type 2 diabetes ', 'T2D) undergoing medical or surgical treatment for T2D', 'obese participants of similar age and racial distribution enrolled in the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) and the Treatment Options of Type 2 Diabetes in Adolescents and Youth (TODAY) studies']","['Surgical Versus Medical Therapy', 'metabolic bariatric surgery (MBS', 'metformin alone or in combination with rosiglitazone or intensive lifestyle intervention, with insulin therapy']","['Elevated UAE', 'Glycemic control, BMI, estimated glomerular filtration rate (eGFR), urinary albumin excretion (UAE), and prevalence of hyperfiltration (eGFR ≥135 mL/min/1.73 m 2 ) and elevated UAE', 'diabetic kidney disease (DKD) rates']","[{'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]",,0.0493397,"Compared with MBS, medical treatment of obese youth with T2D was associated with a higher odds of DKD over 5 years.","[{'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Bjornstad', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO petter.bjornstad@childrenscolorado.org.""}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Hughan', 'Affiliation': ""University of Pittsburgh and UPMC Children's Hospital Pittsburgh, Pittsburgh, PA.""}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Kelsey', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nehus', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mitsnefes', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""University of Cincinnati, Cincinnati Children's Medical Center, Cincinnati, OH.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Inge', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, CO.""}]",Diabetes care,['10.2337/dc19-0708']
291,32151803,"Efficacy and safety of eslicarbazepine acetate as adjunctive therapy for refractory focal-onset seizures in children: A double-blind, randomized, placebo-controlled, parallel-group, multicenter, phase-III clinical trial.","PURPOSE


This was a phase-III, randomized, double-blind, placebo-controlled study aimed to evaluate efficacy and tolerability of eslicarbazepine acetate (ESL) as adjunctive therapy in pediatric patients with refractory focal-onset seizures (FOS).
METHODS


Children (2-18 years old) with FOS, receiving 1-2 antiepileptic drugs, were randomized to ESL or placebo. Treatment was started at 10 mg/kg/day, up-titrated up to 20-30 mg/kg/day, and maintained for 12 weeks, followed by one-year open-label follow-up. Primary efficacy endpoints were relative reduction in standardized seizure frequency (SSF) and proportion of responders (≥50% SSF reduction) from baseline. Safety was evaluated by the incidence of treatment-emergent adverse events (TEAEs).
RESULTS


The intention-to-treat (ITT) set included 134 patients randomized to ESL and 129 to placebo; 89.6% and 91.5%, respectively, completed the trial. An unbalanced number of seizures at baseline were observed between groups. Least square (LS) mean relative change in SSF from baseline was higher in the ESL group (-18.1%) than in placebo (-8.6%). Proportion of responders between ESL and placebo groups was not statistically different. A post hoc analysis showed greater relative reduction in SSF in patients above 6 years old treated with ESL 20 or 30 mg/kg/day compared with placebo; this was significant in patients above 6 years old treated with ESL 30 mg/kg/day (LS mean difference: 31.9%; p = 0.0478). The observed safety profile in children was consistent with that established in adult studies.
CONCLUSIONS


Adjunctive ESL treatment was well-tolerated, but this trial failed to demonstrate that ESL was more effective than placebo in the predefined efficacy endpoints; factors that may have contributed to this outcome, affecting particularly the young age group, include etiological heterogeneity, difficulty in recognizing simple partial seizures, high seizure frequency with risk of imbalance, and underestimation of the efficacious dose range.",2020,A post hoc analysis showed greater relative reduction in SSF in patients above 6 years old treated with ESL 20 or 30 mg/kg/day compared with placebo; this was significant in patients above 6 years old treated with ESL 30 mg/kg/day (LS mean difference: 31.9%; p = 0.0478).,"['134 patients randomized to', 'Children (2-18\u202fyears old) with FOS, receiving 1-2 antiepileptic drugs', 'pediatric patients with refractory focal-onset seizures (FOS', 'refractory focal-onset seizures in children']","['eslicarbazepine acetate', 'eslicarbazepine acetate (ESL', 'placebo', 'ESL', 'ESL or placebo']","['efficacy and tolerability', 'incidence of treatment-emergent adverse events (TEAEs', 'Least square (LS) mean relative change in SSF', 'Efficacy and safety', 'standardized seizure frequency (SSF) and proportion of responders', 'relative reduction in SSF']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C2725262', 'cui_str': 'eslicarbazepine acetate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",134.0,0.707798,A post hoc analysis showed greater relative reduction in SSF in patients above 6 years old treated with ESL 20 or 30 mg/kg/day compared with placebo; this was significant in patients above 6 years old treated with ESL 30 mg/kg/day (LS mean difference: 31.9%; p = 0.0478).,"[{'ForeName': 'Fenella', 'Initials': 'F', 'LastName': 'Kirkham', 'Affiliation': 'University Hospital Southampton, Southampton, UK; Clinical and Experimental Sciences, University of Southampton, UK; Developmental Neurosciences, UCL Institute of Child Health, London, UK.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Auvin', 'Affiliation': 'Robert-Debré University Hospital, Paris, France.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Moreira', 'Affiliation': 'BIAL - Portela & Cª. S.A., S. Mamede do Coronado, Portugal.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gama', 'Affiliation': 'BIAL - Portela & Cª. S.A., S. Mamede do Coronado, Portugal.'}, {'ForeName': 'Amílcar C', 'Initials': 'AC', 'LastName': 'Falcão', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, University Coimbra, Coimbra, Portugal.'}, {'ForeName': 'José-Francisco', 'Initials': 'JF', 'LastName': 'Rocha', 'Affiliation': 'BIAL - Portela & Cª. S.A., S. Mamede do Coronado, Portugal.'}, {'ForeName': 'Patrício', 'Initials': 'P', 'LastName': 'Soares-da-Silva', 'Affiliation': 'BIAL - Portela & Cª. S.A., S. Mamede do Coronado, Portugal; Department of Biomedicine, Pharmacology and Therapeutics Unit, Faculty of Medicine, University Porto, Porto, Portugal; MedInUP - Center for Drug Discovery and Innovative Medicines, University Porto, Porto, Portugal. Electronic address: psoares.silva@bial.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.106962']
292,32164906,"Upfront FOLFOXIRI plus bevacizumab and reintroduction after progression versus mFOLFOX6 plus bevacizumab followed by FOLFIRI plus bevacizumab in the treatment of patients with metastatic colorectal cancer (TRIBE2): a multicentre, open-label, phase 3, randomised, controlled trial.","BACKGROUND


The triplet FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab showed improved outcomes for patients with metastatic colorectal cancer, compared with FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab. However, the actual benefit of the upfront exposure to the three cytotoxic drugs compared with a preplanned sequential strategy of doublets was not clear, and neither was the feasibility or efficacy of therapies after disease progression. We aimed to compare a preplanned strategy of upfront FOLFOXIRI followed by the reintroduction of the same regimen after disease progression versus a sequence of mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) and FOLFIRI doublets, in combination with bevacizumab.
METHODS


TRIBE2 was an open-label, phase 3, randomised study of patients aged 18-75 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 2, with unresectable, previously untreated metastatic colorectal cancer, recruited from 58 Italian oncology units. Patients were stratified according to centre, ECOG performance status, primary tumour location, and previous adjuvant chemotherapy. A randomisation system incorporating a minimisation algorithm was used to randomly assign patients (1:1) via a masked web-based allocation procedure to two different treatment strategies. In the control group, patients received first-line mFOLFOX6 (85 mg/m 2  of intravenous oxaliplatin concurrently with 200 mg/m 2  of leucovorin over 120 min; 400 mg/m 2  intravenous bolus of fluorouracil; 2400 mg/m 2  continuous infusion of fluorouracil for 48 h) plus bevacizumab (5 mg/kg intravenously over 30 min) followed by FOLFIRI (180 mg/m 2  of intravenous irinotecan over 120 min concurrently with 200 mg/m 2  of leucovorin; 400 mg/m 2  intravenous bolus of fluorouracil; 2400 mg/m 2  continuous infusion of fluorouracil for 48 h) plus bevacizumab after disease progression. In the experimental group, patients received FOLFOXIRI (165 mg/m 2  of intravenous irinotecan over 60 min; 85 mg/m 2  intravenous oxaliplatin concurrently with 200 mg/m 2  of leucovorin over 120 min; 3200 mg/m 2  continuous infusion of fluorouracil for 48 h) plus bevacizumab followed by the reintroduction of the same regimen after disease progression. Combination treatments were repeated every 14 days for up to eight cycles followed by fluorouracil and leucovorin (at the same dose administered at the last induction cycle) plus bevacizumab maintenance until disease progression, unacceptable adverse events, or consent withdrawal. Patients and investigators were not masked. The primary endpoint was progression-free survival 2, defined as the time from randomisation to disease progression on any treatment given after first disease progression, or death, analysed by intention to treat. Safety was assessed in patients who received at least one dose of their assigned treatment. Study recruitment is complete and follow-up is ongoing. This trial is registered with Clinicaltrials.gov, NCT02339116.
FINDINGS


Between Feb 26, 2015, and May 15, 2017, 679 patients were randomly assigned and received treatment (340 in the control group and 339 in the experimental group). At data cut-off (July 30, 2019) median follow-up was 35·9 months (IQR 30·1-41·4). Median progression-free survival 2 was 19·2 months (95% CI 17·3-21·4) in the experimental group and 16·4 months (15·1-17·5) in the control group (hazard ratio [HR] 0·74, 95% CI 0·63-0·88; p=0·0005). During the first-line treatment, the most frequent of all-cause grade 3-4 events were diarrhoea (57 [17%] vs 18 [5%]), neutropenia (168 [50%] vs 71 [21%]), and arterial hypertension (25 [7%] vs 35 [10%]) in the experimental group compared with the control group. Serious adverse events occurred in 84 (25%) patients in the experimental group and in 56 (17%) patients in the control group. Eight treatment-related deaths were reported in the experimental group (two intestinal occlusions, two intestinal perforations, two sepsis, one myocardial infarction, and one bleeding) and four in the control group (two occlusions, one perforation, and one pulmonary embolism). After first disease progression, no substantial differences in the incidence of grade 3 or 4 adverse events were reported between the control and experimental groups, with the exception of neurotoxicity, which was only reported in the experimental group (six [5%] of 132 patients). Serious adverse events after disease progression occurred in 20 (15%) patients in the experimental group and 25 (12%) in the control group. Three treatment-related deaths after first disease progression were reported in the experimental group (two intestinal occlusions and one sepsis) and four in the control group (one intestinal occlusion, one intestinal perforation, one cerebrovascular event, and one sepsis).
INTERPRETATION


Upfront FOLFOXIRI plus bevacizumab followed by the reintroduction of the same regimen after disease progression seems to be a preferable therapeutic strategy to sequential administration of chemotherapy doublets, in combination with bevacizumab, for patients with metastatic colorectal cancer selected according to the study criteria.
FUNDING


The GONO Cooperative Group, the ARCO Foundation, and F Hoffmann-La Roche.",2020,"After first disease progression, no substantial differences in the incidence of grade 3 or 4 adverse events were reported between the control and experimental groups, with the exception of neurotoxicity, which was only reported in the experimental group (six [5%] of 132 patients).","['patients aged 18-75 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 2, with unresectable, previously untreated metastatic colorectal cancer, recruited from 58 Italian oncology units', 'Between Feb 26, 2015, and May 15, 2017, 679 patients were randomly assigned and received treatment (340 in the control group and 339 in the experimental group', 'patients with metastatic colorectal cancer selected according to the study criteria', 'patients with metastatic colorectal cancer (TRIBE2', 'patients with metastatic colorectal cancer']","['first-line mFOLFOX6', 'FOLFOXIRI', 'intravenous irinotecan', 'fluorouracil and leucovorin', 'Upfront FOLFOXIRI plus bevacizumab', 'FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab', 'leucovorin', 'fluorouracil', 'FOLFIRI (180 mg/m 2  of intravenous irinotecan', 'mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin', 'fluorouracil; 2400 mg/m 2  continuous infusion of fluorouracil', 'bevacizumab', 'FOLFIRI plus bevacizumab', 'mFOLFOX6 plus bevacizumab', 'triplet FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab', 'oxaliplatin']","['Median progression-free survival', 'intestinal occlusion, one intestinal perforation, one cerebrovascular event, and one sepsis', 'intestinal perforations, two sepsis, one myocardial infarction, and one bleeding', 'diarrhoea', 'progression-free survival 2, defined as the time from randomisation to disease progression on any treatment given after first disease progression, or death, analysed by intention to treat', 'Serious adverse events', 'incidence of grade 3 or 4 adverse events', 'neutropenia', 'neurotoxicity', 'Safety', 'Serious adverse events after disease progression', 'arterial hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4553808', 'cui_str': 'Intestinal occlusion'}, {'cui': 'C0021845', 'cui_str': 'Intestinal Perforation'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0580351', 'cui_str': 'Treatment given'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",679.0,0.0771876,"After first disease progression, no substantial differences in the incidence of grade 3 or 4 adverse events were reported between the control and experimental groups, with the exception of neurotoxicity, which was only reported in the experimental group (six [5%] of 132 patients).","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rossini', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Loupakis', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy; Oncology and Hemato-oncology Department, Università degli Studi di Milano, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bordonaro', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione, Garibaldi Catania, Catania, Italy.'}, {'ForeName': 'Tiziana Pia', 'Initials': 'TP', 'LastName': 'Latiano', 'Affiliation': 'Oncology Unit, Foundation IRCCS, Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Tamburini', 'Affiliation': 'Oncology Unit, Ospedale degli Infermi, Rimini, Italy; Department of Oncology and Palliative Care, Cardinale G Panico, Tricase City Hospital, Tricase, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Santini', 'Affiliation': 'Department of Medical Oncology, University Campus Biomedico, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Passardi', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Marmorino', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Grande', 'Affiliation': 'Department of Medical Oncology, F Spaziani Hospital, Lazio, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Aprile', 'Affiliation': 'Department of Oncology, University and General Hospital, Udine, Italy; Department of Oncology, San Bortolo General Hospital, Vicenza, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Poliambulanza Foundation, Brescia, Italy.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Murgioni', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Granetto', 'Affiliation': 'Department of Oncology, S Croce and Carle Teaching Hospital, Cuneo, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Buonadonna', 'Affiliation': 'Department of Medical Oncology, IRCCS, Centro di Riferimento Oncologico National Cancer Institute, Aviano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Moretto', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cordio', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione, Garibaldi Catania, Catania, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Antonuzzo', 'Affiliation': 'Medical Oncology Unit, Careggi University Hospital, Florence, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Tomasello', 'Affiliation': 'Medical Oncology Unit, Azienda Socio-Sanitaria Territoriale of Cremona, Cremona Hospital, Cremona, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ronzoni', 'Affiliation': 'Department of Oncology, Hospital San Raffaele, IRCCS, Milan, Italy.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Di Donato', 'Affiliation': 'Department of Medical Oncology, General Hospital, Prato, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Carlomagno', 'Affiliation': 'Department of Clinical Medicine and Surgery, University Federico II, Napoli, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Clavarezza', 'Affiliation': 'Medical Oncology Unit, Ente Ospedaliero Ospedali Galliera, Genoa, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Ritorto', 'Affiliation': 'Struttura Semplice Dipartimentale, ColoRectal Cancer Unit, Department of Oncology, Azienda Ospedaliero-Universitaria, Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mambrini', 'Affiliation': 'Oncological Department, Azienda UnitàSanitaria Locale, Toscana Nord Ovest, Oncological Unit of Massa Carrara, Carrara, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Roselli', 'Affiliation': 'Department of Systems Medicine, Medical Oncology Unit, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Samanta', 'Initials': 'S', 'LastName': 'Cupini', 'Affiliation': 'Department of Oncology, Division of Medical Oncology, Azienda Toscana Nord Ovest, Livorno, Italy.'}, {'ForeName': 'Serafina', 'Initials': 'S', 'LastName': 'Mammoliti', 'Affiliation': 'Medical Oncology, IRCCS, Ospedale San Martino Istituto Scientifico Tumori, Genoa, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Fenocchio', 'Affiliation': ""Department of Medical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l'Oncologia, IRCCS, Candiolo, Italy.""}, {'ForeName': 'Enrichetta', 'Initials': 'E', 'LastName': 'Corgna', 'Affiliation': 'Unit of Medical Oncology, Ospedale Santa Maria della Misericordia, Perugia, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Medical Oncology Unit 1, Department of Clinical and Experimental Oncology, IRCCS, Padua, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Fontanini', 'Affiliation': 'Department of Surgical, Medical, Molecular Pathology and Critical Area, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Ugolini', 'Affiliation': 'Department of Laboratory, Pathology section, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Clinical Trials Coordinating Center, Toscano Cancer Institute, University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Oncology, University Hospital of Pisa, Pisa, Italy; Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy. Electronic address: alfredo.falcone@med.unipi.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30862-9']
293,31577036,Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial.,"Importance


High-flow nasal oxygen may prevent postextubation respiratory failure in the intensive care unit (ICU). The combination of high-flow nasal oxygen with noninvasive ventilation (NIV) may be an optimal strategy of ventilation to avoid reintubation.
Objective


To determine whether high-flow nasal oxygen with prophylactic NIV applied immediately after extubation could reduce the rate of reintubation, compared with high-flow nasal oxygen alone, in patients at high risk of extubation failure in the ICU.
Design, Setting, and Participants


Multicenter randomized clinical trial conducted from April 2017 to January 2018 among 641 patients at high risk of extubation failure (ie, older than 65 years or with an underlying cardiac or respiratory disease) at 30 ICUs in France; follow-up was until April 2018.
Interventions


Patients were randomly assigned to high-flow nasal oxygen alone (n = 306) or high-flow nasal oxygen alternating with NIV (n = 342) immediately after extubation.
Main Outcomes and Measures


The primary outcome was the proportion of patients reintubated at day 7; secondary outcomes included postextubation respiratory failure at day 7, reintubation rates up until ICU discharge, and ICU mortality.
Results


Among 648 patients who were randomized (mean [SD] age, 70 [10] years; 219 women [34%]), 641 patients completed the trial. The reintubation rate at day 7 was 11.8% (95% CI, 8.4%-15.2%) (40/339) with high-flow nasal oxygen and NIV and 18.2% (95% CI, 13.9%-22.6%) (55/302) with high-flow nasal oxygen alone (difference, -6.4% [95% CI, -12.0% to -0.9%]; P = .02). Among the 11 prespecified secondary outcomes, 6 showed no significant difference. The proportion of patients with postextubation respiratory failure at day 7 (21% vs 29%; difference, -8.7% [95% CI, -15.2% to -1.8%]; P = .01) and reintubation rates up until ICU discharge (12% vs 20%, difference -7.4% [95% CI, -13.2% to -1.8%]; P = .009) were significantly lower with high-flow nasal oxygen and NIV than with high-flow nasal oxygen alone. ICU mortality rates were not significantly different: 6% with high-flow nasal oxygen and NIV and 9% with high-flow nasal oxygen alone (difference, -2.4% [95% CI, -6.7% to 1.7%]; P = .25).
Conclusions and Relevance


In mechanically ventilated patients at high risk of extubation failure, the use of high-flow nasal oxygen with NIV immediately after extubation significantly decreased the risk of reintubation compared with high-flow nasal oxygen alone.
Trial Registration


ClinicalTrials.gov Identifier: NCT03121482.",2019,"ICU mortality rates were not significantly different: 6% with high-flow nasal oxygen and NIV and 9% with high-flow nasal oxygen alone (difference, -2.4% [95% CI, -6.7% to 1.7%]; P = .25).
","['648 patients who were randomized (mean [SD] age, 70 [10] years; 219 women [34%]), 641 patients completed the trial', 'Patients at High Risk of Extubation Failure', 'patients at high risk of extubation failure in the ICU', 'April 2017 to January 2018 among 641 patients at high risk of extubation failure (ie, older than 65 years or with an underlying cardiac or respiratory disease) at 30 ICUs in France; follow-up was until April 2018', 'mechanically ventilated patients at high risk of extubation failure']","['Postextubation High-Flow Nasal Oxygen', 'high-flow nasal oxygen with noninvasive ventilation (NIV', 'Noninvasive Ventilation', 'High-Flow Nasal Oxygen Alone', 'high-flow nasal oxygen alone (n\u2009=\u2009306) or high-flow nasal oxygen with NIV (n\u2009=\u2009342) immediately after extubation']","['reintubation rates up until ICU discharge', 'ICU mortality rates', 'postextubation respiratory failure', 'rate of reintubation', 'reintubation rate', 'proportion of patients with postextubation respiratory failure', 'proportion of patients reintubated at day 7; secondary outcomes included postextubation respiratory failure at day 7, reintubation rates up until ICU discharge, and ICU mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0035204', 'cui_str': 'Respiration Disorders'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",641.0,0.287349,"ICU mortality rates were not significantly different: 6% with high-flow nasal oxygen and NIV and 9% with high-flow nasal oxygen alone (difference, -2.4% [95% CI, -6.7% to 1.7%]; P = .25).
","[{'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Muller', 'Affiliation': ""Groupe Hospitalier Régional d'Orléans, Médecine Intensive Réanimation, Orléans, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gacouin', 'Affiliation': 'Centre Hospitalier Universitaire de Rennes, Hôpital Ponchaillou, Service des Maladies Infectieuses et Réanimation Médicale, Rennes, France.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Coudroy', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': 'Maxens', 'Initials': 'M', 'LastName': 'Decavèle', 'Affiliation': 'Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie, Médecine Intensive et Réanimation (Département R3S), AP-HP, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Sonneville', 'Affiliation': 'Hôpital Bichat-Claude Bernard, Médecine Intensive Réanimation, AP-HP, Université Paris Diderot, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Beloncle', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Département de Médecine Intensive Réanimation, Université d'Angers, Angers, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Girault', 'Affiliation': 'Centre Hospitalier Universitaire de Rouen, Hôpital Charles Nicolle, Département de Réanimation Médicale, Normandie Université, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), Rouen, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Dangers', 'Affiliation': 'Centre Hospitalier Universitaire Félix Guyon, Service de Réanimation Polyvalente, Saint Denis de la Réunion, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Réanimation Médicale, Clermont-Ferrand, France.'}, {'ForeName': 'Séverin', 'Initials': 'S', 'LastName': 'Cabasson', 'Affiliation': 'Centre Hospitalier de La Rochelle, Service de Réanimation, La Rochelle, France.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Rouzé', 'Affiliation': 'Centre Hospitalier Universitaire de Lille, Centre de Réanimation, Université de Lille, Lille, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Vivier', 'Affiliation': 'Hôpital Saint-Joseph Saint-Luc, Réanimation Polyvalente, Lyon, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Le Meur', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Médecine Intensive Réanimation, Nantes, France.'}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': 'Hôpital Louis Mourier, Réanimation Médico-Chirurgicale, AP-HP, INSERM, Université Paris Diderot, UMR IAME 1137, Sorbonne Paris Cité, Colombes, France.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Razazi', 'Affiliation': 'Hôpitaux universitaires Henri Mondor, Service de Réanimation Médicale DHU A-TVB, AP-HP, Créteil, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Barberet', 'Affiliation': 'Groupe Hospitalier Régional Mulhouse Sud Alsace, site Emile Muller, Service de Réanimation Médicale, Mulhouse, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lebert', 'Affiliation': 'Centre Hospitalier Départemental de Vendée, Service de Médecine Intensive Réanimation, La Roche Sur Yon, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': ""Centre Hospitalier Régional Universitaire de Tours, Médecine Intensive Réanimation, CIC 1415, Réseau CRICS-Trigger SEP, Centre d'étude des pathologies respiratoires, INSERM U1100, Université de Tours, Tours, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sabatier', 'Affiliation': 'Centre Hospitalier de Pau, Service de Réanimation, Pau, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': 'Centre Hospitalier Universitaire La Timone 2, Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Pradel', 'Affiliation': ""Centre Hospitalier Henri Mondor d'Aurillac, Service de Réanimation, Aurillac, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bailly', 'Affiliation': 'Centre Hospitalier Universitaire de Brest, Médecine Intensive Réanimation, Brest, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Terzi', 'Affiliation': 'Centre Hospitalier Universitaire Grenoble Alpes, Médecine Intensive Réanimation, INSERM, Université Grenoble-Alpes, U1042, HP2, Grenoble, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dellamonica', 'Affiliation': ""Centre Hospitalier Universitaire de Nice, Médecine Intensive Réanimation, Archet 1, Université Cote d'Azur, Nice, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lacave', 'Affiliation': 'Centre Hospitalier de Versailles, Service de Réanimation Médico-Chirurgicale, Le Chesnay, France.'}, {'ForeName': 'Pierre-Éric', 'Initials': 'PÉ', 'LastName': 'Danin', 'Affiliation': 'Centre Hospitalier Universitaire de Nice, Réanimation Médico-Chirurgicale Archet 2, INSERM U 1065, Nice, France.'}, {'ForeName': 'Hodanou', 'Initials': 'H', 'LastName': 'Nanadoumgar', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Réanimation Chirurgicale, Poitiers, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Gibelin', 'Affiliation': 'Hôpital Tenon, Réanimation et USC médico-chirurgicale, CARMAS, AP-HP, Faculté de médecine Sorbonne Université, Collegium Galilée, Paris, France.'}, {'ForeName': 'Lassane', 'Initials': 'L', 'LastName': 'Zanre', 'Affiliation': 'Centre Hospitalier Emile Roux, Service de Réanimation, Le Puy en Velay, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Deye', 'Affiliation': 'Hôpital Lariboisière, Réanimation Médicale et Toxicologique, AP-HP, INSERM UMR-S 942, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Demoule', 'Affiliation': 'Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie, Médecine Intensive et Réanimation (Département R3S), AP-HP, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Maamar', 'Affiliation': 'Centre Hospitalier Universitaire de Rennes, Hôpital Ponchaillou, Service des Maladies Infectieuses et Réanimation Médicale, Rennes, France.'}, {'ForeName': 'Mai-Anh', 'Initials': 'MA', 'LastName': 'Nay', 'Affiliation': ""Groupe Hospitalier Régional d'Orléans, Médecine Intensive Réanimation, Orléans, France.""}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Robert', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': ""INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.14901']
294,32171426,"Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study.","BACKGROUND


CLEOPATRA was a phase 3 study comparing the efficacy and safety of pertuzumab, trastuzumab, and docetaxel with placebo, trastuzumab, and docetaxel in patients with HER2-positive metastatic breast cancer. In the primary analysis and subsequent reports, progression-free and overall survival were significantly improved in the pertuzumab group compared with the placebo group. Here, we report the end-of-study analysis of CLEOPATRA.
METHODS


This was a double-blind, randomised, placebo-controlled, phase 3 trial that was done at 204 centres in 25 countries. Eligible patients were 18 years or older, had HER2-positive, metastatic breast cancer, had not received previous chemotherapy or biological treatment for their metastatic disease, and had an Eastern Cooperative Oncology Group performance status of 0 or 1. All study drugs were given intravenously, every 3 weeks. Patients were assigned to receive either pertuzumab or placebo at a loading dose of 840 mg, and 420 mg thereafter; plus trastuzumab at 8 mg/kg loading dose and 6 mg/kg thereafter; and docetaxel at 75 mg/m 2 , escalating to 100 mg/m 2  if tolerated. Pertuzumab or placebo and trastuzumab were given until disease progression; docetaxel was given for six cycles, or longer at the investigators' discretion. Randomisation (1:1) was done by use of an interactive voice-response system and was stratified by geographical region (Asia, Europe, North America, or South America) and previous treatment (previous adjuvant or neoadjuvant chemotherapy vs none). The primary endpoint was independent review facility-assessed progression-free survival, which has been reported previously. Since the confirmatory overall survival analysis had also occurred before this prespecified end-of-study analysis, analyses presented here are descriptive. Overall survival analyses were based on the intention-to-treat population with crossover patients analysed in the placebo group; analyses were not adjusted for crossover to the pertuzumab group and are likely to be conservative. Safety analyses were based on treatment received; crossover patients were counted in the placebo group up to the day before first pertuzumab dose. This trial is registered with ClinicalTrials.gov, number NCT00567190.
FINDINGS


Between Feb 12, 2008, and July 7, 2010, 1196 patients were assessed for eligibility, of whom 808 were enrolled and randomly assigned. 402 patients were assigned to receive docetaxel plus trastuzumab plus pertuzumab, and 406 patients were assigned to receive docetaxel plus trastuzumab plus placebo. Clinical cutoff for this analysis was Nov 23, 2018. Between July 2012 and clinical cutoff, 50 patients crossed from the placebo to the pertuzumab group. Median follow-up was 99·9 months in the pertuzumab group (IQR 92·9-106·4) and 98·7 months (90·9-105·7) in the placebo group. Median overall survival was 57·1 months (95% CI 50-72) in the pertuzumab group and 40·8 months (36-48) in the placebo group (hazard ratio 0·69, 95% CI 0·58-0·82); 8-year landmark overall survival rates were 37% (95% CI 31-42) in the pertuzumab group and 23% (19-28) in the placebo group. The most common grade 3-4 adverse event was neutropenia (200 [49%] of 408 patients in the pertuzumab group, 183 [46%] of 396 patients in the placebo group). Five (1%) of 408 patients in the pertuzumab group and six (2%) of 396 patients in the placebo group had treatment-related deaths. One new serious adverse event suggestive of congestive heart failure (pertuzumab group) and one new symptomatic left ventricular systolic dysfunction (post-crossover) occurred since the previous analysis.
INTERPRETATION


Our analysis shows that the previously observed improvements in overall survival with pertuzumab, trastuzumab, and docetaxel versus placebo, trastuzumab, and docetaxel were maintained after a median of more than 8 years of follow-up. The long-term safety and cardiac safety profiles of pertuzumab, trastuzumab, and docetaxel were maintained in the overall safety population and within crossover patients. HER2-targeted therapy has changed the natural history of HER2-positive metastatic breast cancer, with the dual blockade of pertuzumab and trastuzumab, with docetaxel, demonstrating an 8-year landmark overall survival rate of 37%.
FUNDING


F Hoffmann-La Roche and Genentech.",2020,"In the primary analysis and subsequent reports, progression-free and overall survival were significantly improved in the pertuzumab group compared with the placebo group.","['1196 patients were assessed for eligibility, of whom 808 were enrolled and randomly assigned', 'patients with HER2-positive metastatic breast cancer', 'HER2-positive metastatic breast cancer (CLEOPATRA', ' and 406 patients', 'Between Feb 12, 2008, and July 7, 2010', '204 centres in 25 countries', 'Eligible patients were 18 years or older, had HER2-positive, metastatic breast cancer, had not received previous chemotherapy or biological treatment for their metastatic disease, and had an Eastern Cooperative Oncology Group performance status of 0 or 1', '402 patients']","['pertuzumab, trastuzumab, and docetaxel versus placebo, trastuzumab, and docetaxel', 'trastuzumab', 'docetaxel plus trastuzumab\u2008plus\u2008placebo', 'docetaxel plus trastuzumab\u2008plus\u2008pertuzumab', 'HER2-targeted therapy', 'placebo', 'pertuzumab or placebo', 'docetaxel', 'pertuzumab, trastuzumab, and docetaxel', 'Pertuzumab or placebo and trastuzumab', 'pertuzumab, trastuzumab, and docetaxel with placebo, trastuzumab, and docetaxel', 'Pertuzumab, trastuzumab, and docetaxel']","['overall survival', 'treatment-related deaths', '8-year landmark overall survival rates', 'Overall survival analyses', 'Median overall survival', 'neutropenia', 'progression-free and overall survival', 'review facility-assessed progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0323987', 'cui_str': 'Cleopatra'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1531518', 'cui_str': 'Biological treatment'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1196.0,0.69218,"In the primary analysis and subsequent reports, progression-free and overall survival were significantly improved in the pertuzumab group compared with the placebo group.","[{'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'Georgetown University Medical Center, Washington DC, USA; Lombardi Comprehensive Cancer Center, Washington, DC, USA; MedStar Health, Washington, DC, USA. Electronic address: sandra.swain@georgetown.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Semiglazov', 'Affiliation': 'N N Petrov Research Institute of Oncology, St Petersburg, Russia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': '12 de Octubre University Hospital, Medical Oncology Department, Madrid, Spain.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, University Hospital, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Monturus', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clark', 'Affiliation': 'Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Knott', 'Affiliation': 'Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Restuccia', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Benyunes', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""IOB Institute of Oncology, Quirónsalud Group, Madrid and Barcelona, Spain; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30863-0']
295,32171429,"Imaging-based target volume reduction in chemoradiotherapy for locally advanced non-small-cell lung cancer (PET-Plan): a multicentre, open-label, randomised, controlled trial.","BACKGROUND


With increasingly precise radiotherapy and advanced medical imaging, the concept of radiotherapy target volume planning might be redefined with the aim of improving outcomes. We aimed to investigate whether target volume reduction is feasible and effective compared with conventional planning in the context of radical chemoradiotherapy for patients with locally advanced non-small-cell lung cancer.
METHODS


We did a multicentre, open-label, randomised, controlled trial (PET-Plan; ARO-2009-09) in 24 centres in Austria, Germany, and Switzerland. Previously untreated patients (aged older than 18 years) with inoperable locally advanced non-small-cell lung cancer suitable for chemoradiotherapy and an Eastern Cooperative Oncology Group performance status of less than 3 were included. Undergoing  18 F-fluorodeoxyglucose ( 18 F-FDG) PET and CT for treatment planning, patients were randomly assigned (1:1) using a random number generator and block sizes between four and six to target volume delineation informed by  18 F-FDG PET and CT plus elective nodal irradiation (conventional target group) or target volumes informed by PET alone ( 18 F-FDG PET-based target group). Randomisation was stratified by centre and Union for International Cancer Control stage. In both groups, dose-escalated radiotherapy (60-74 Gy, 2 Gy per fraction) was planned to the respective target volumes and applied with concurrent platinum-based chemotherapy. The primary endpoint was time to locoregional progression from randomisation with the objective to test non-inferiority of  18 F-FDG PET-based planning with a prespecified hazard ratio (HR) margin of 1·25. The per-protocol set was included in the primary analysis. The safety set included all patients receiving any study-specific treatment. Patients and study staff were not masked to treatment assignment. This study is registered with ClinicalTrials.gov, NCT00697333.
FINDINGS


From May 13, 2009, to Dec 5, 2016, 205 of 311 recruited patients were randomly assigned to the conventional target group (n=99) or the  18 F-FDG PET-based target group (n=106; the intention-to-treat set), and 172 patients were treated per protocol (84 patients in the conventional target group and 88 in the  18 F-FDG PET-based target group). At a median follow-up of 29 months (IQR 9-54), the risk of locoregional progression in the  18 F-FDG PET-based target group was non-inferior to, and in fact lower than, that in the conventional target group in the per-protocol set (14% [95% CI 5-21] vs 29% [17-38] at 1 year; HR 0·57 [95% CI 0·30-1·06]). The risk of locoregional progression in the  18 F-FDG PET-based target group was also non-inferior to that in the conventional target group in the intention-to-treat set (17% [95% CI 9-24] vs 30% [20-39] at 1 year; HR 0·64 [95% CI 0·37-1·10]). The most common acute grade 3 or worse toxicity was oesophagitis or dysphagia (16 [16%] of 99 patients in the conventional target group vs 17 [16%] of 105 patients in the  18 F-FDG PET-based target group); the most common late toxicities were lung-related (12 [12%] vs 11 [10%]). 20 deaths potentially related to study treatment were reported (seven vs 13).
INTERPRETATION


18 F-FDG PET-based planning could potentially improve local control and does not seem to increase toxicity in patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer. Imaging-based target volume reduction in this setting is, therefore, feasible, and could potentially be considered standard of care. The procedures established might also support imaging-based target volume reduction concepts for other tumours.
FUNDING


German Cancer Aid (Deutsche Krebshilfe).",2020,"INTERPRETATION


18 F-FDG PET-based planning could potentially improve local control and does not seem to increase toxicity in patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer.","['locally advanced non-small-cell lung cancer (PET-Plan', 'patients with locally advanced non-small-cell lung cancer', '24 centres in Austria, Germany, and Switzerland', 'From May 13, 2009, to Dec 5, 2016, 205 of 311 recruited patients', 'Previously untreated patients (aged older than 18 years) with inoperable locally advanced non-small-cell lung cancer suitable for chemoradiotherapy and an Eastern Cooperative Oncology Group performance status of less than 3 were included', 'patients receiving any study-specific treatment', 'patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer']","['conventional planning', 'Imaging-based target volume reduction in chemoradiotherapy', 'concurrent platinum-based chemotherapy', 'conventional target group (n=99) or the  18 F-FDG PET-based target group', 'radiotherapy', 'radical chemoradiotherapy', 'random number generator and block sizes between four and six to target volume delineation informed by  18 F-FDG PET and CT plus elective nodal irradiation (conventional target group) or target volumes informed by PET alone ( 18 F-FDG PET-based target group', 'Undergoing  18 F-fluorodeoxyglucose ( 18 F-FDG) PET and CT']","['toxicity was oesophagitis or dysphagia', 'time to locoregional progression from randomisation with the objective to test non-inferiority of  18 F-FDG PET-based planning with a prespecified hazard ratio (HR) margin of 1·25', 'risk of locoregional progression', 'toxicity', 'late toxicities']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",311.0,0.27767,"INTERPRETATION


18 F-FDG PET-based planning could potentially improve local control and does not seem to increase toxicity in patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer.","[{'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Nestle', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; German Cancer Consortium Partner Site Freiburg and German Cancer Research Center, Heidelberg, Germany; Department of Radiation Oncology, Kliniken Maria Hilf, Mönchengladbach, Germany. Electronic address: ursula.nestle@mariahilf.de.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Schimek-Jasch', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kremp', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaefer-Schuler', 'Affiliation': 'Department of Nuclear Medicine, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mix', 'Affiliation': 'Department of Nuclear Medicine, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Küsters', 'Affiliation': 'Department of Radiation Oncology, Kliniken Maria Hilf, Mönchengladbach, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tosch', 'Affiliation': 'Department of Nuclear Medicine, Helios University Hospital Wuppertal, Wuppertal, Germany; Department of Medicine, Faculty of Health, University of Witten/Herdecke, Witten, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hehr', 'Affiliation': 'Department of Radiation Oncology, Marienhospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Susanne Martina', 'Initials': 'SM', 'LastName': 'Eschmann', 'Affiliation': 'Department of Nuclear Medicine, Marienhospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Yves-Pierre', 'Initials': 'YP', 'LastName': 'Bultel', 'Affiliation': 'Department of Radiation Oncology, Klinikum Mutterhaus der Boromäerinnen, Trier, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hass', 'Affiliation': 'Department of Radiation Oncology, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Fleckenstein', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, Homburg/Saar, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Thieme', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany; Department of Radiation Oncology, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Stockinger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Dieckmann', 'Affiliation': 'Department of Radiotherapy, Medical University of Vienna, Vienna General Hospital, Vienna, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Miederer', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Holl', 'Affiliation': 'Department of Nuclear Medicine, Helios Kliniken Schwerin, Schwerin, Germany.'}, {'ForeName': 'H Christian', 'Initials': 'HC', 'LastName': 'Rischke', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; Department of Nuclear Medicine, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Gkika', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Adebahr', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; German Cancer Consortium Partner Site Freiburg and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Anca-Ligia', 'Initials': 'AL', 'LastName': 'Grosu', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany; German Cancer Consortium Partner Site Freiburg and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30013-9']
296,31668666,Comparison of intraosseous and submucosal dexamethasone injection in mandibular third molar surgery: a split-mouth randomized clinical trial.,"The objective of this study was to compare the effect of intraosseous dexamethasone injection and submucosal dexamethasone injection on postoperative sequelae after mandibular third molar surgery. This was a randomized, triple-blind, split-mouth clinical trial. Fifty-four mandibular third molars (27 patients) were subdivided according to the side (right and left); intraosseous injection of dexamethasone (4mg) was randomly assigned to one side and submucosal injection to the other. All surgeries were performed by one surgeon. Postoperative pain was evaluated by visual analogue scale score immediately after surgery and on postoperative days 1, 3, and 7. Postoperative swelling (determined using two linear measurements) and mouth opening (determined by measurement of the inter-incisal distance) were assessed on postoperative days 3 and 7. The number of analgesics consumed was recorded. No significant difference in pain or swelling was found between the two injection techniques. However, there was significant difference in trismus on postoperative day 3, with submucosal injection showing a better outcome (P<0.001). Both techniques of dexamethasone injection were effective in controlling pain and swelling after mandibular third molar surgery, but submucosal injection was superior for the control of trismus.",2020,No significant difference in pain or swelling was found between the two injection techniques.,"['after mandibular third molar surgery', 'mandibular third molar surgery', 'Fifty-four mandibular third molars (27 patients']","['intraosseous dexamethasone injection and submucosal dexamethasone injection', 'intraosseous and submucosal dexamethasone injection', 'dexamethasone injection', 'dexamethasone']","['visual analogue scale score', 'pain or swelling', 'trismus', 'Postoperative pain', 'Postoperative swelling', 'postoperative sequelae', 'number of analgesics', 'controlling pain and swelling']","[{'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4692162', 'cui_str': 'Dexamethasone Injection [Dexycu]'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}]",54.0,0.366993,No significant difference in pain or swelling was found between the two injection techniques.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kaewkumnert', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Phithaksinsuk', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Changpoo', 'Affiliation': 'Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Nochit', 'Affiliation': 'Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Muensaiyat', 'Affiliation': 'Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wilaipornsawai', 'Affiliation': 'Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Piriyaphokai', 'Affiliation': 'Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Powcharoen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Chiang Mai University, Chiang Mai, Thailand. Electronic address: warit.p@cmu.ac.th.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.10.006']
297,31922899,The Effect of Continuous Positive Airway Pressure on Vascular Function and Cardiac Structure in Diabetes and Sleep Apnea. A Randomized Controlled Trial.,"Rationale:  Although both type 2 diabetes mellitus (T2DM) and obstructive sleep apnea (OSA) are independently recognized as risk factors for cardiovascular disease, little is known about their interaction. Objectives:  We hypothesized that T2DM and OSA act synergistically to increase vascular risk, and that treatment of OSA would improve vascular reactivity in patients with T2DM plus OSA. Methods:  Cross-sectional study of 141 adults with T2DM, OSA, T2DM plus OSA, and control subjects, followed by a 3-month, parallel-arm, randomized, placebo-controlled trial comparing active and sham continuous positive airway pressure (CPAP) in 53 adults with T2DM plus OSA. Endothelium-dependent macro- and microvascular reactivity (flow-mediated dilation [FMD] of the brachial artery and acetylcholine-induced dilation of forearm microvasculature, respectively) and cardiovascular magnetic resonance to assess left- and right-ventricular mass/volume. Results:  Mean (±SD) FMD was 6.1 (±4.0)%, 7.3 (±3.6)%, 6.8 (±4.5)%, and 4.8 (±2.9)% in control subjects, T2DM only, OSA only, and T2DM plus OSA, respectively. We observed a significant T2DM × OSA interaction on FMD, such that the mean effect of OSA in those with T2DM was 3.1% (95% confidence interval [CI], 0.6 to 5.6) greater than the effect of OSA in those without T2DM. A total of 3 months of CPAP resulted in a mean absolute increase in FMD of 0.3% (95% CI, -1.9 to 2.5; primary endpoint), with a net improvement of 1.1% (95% CI, -1.4 to 3.6) among those with adherence of 4 h/night or greater. A significant T2DM × OSA interaction was found for both left ventricular (LV) and right ventricular end-diastolic volume, such that OSA was associated with a 22.4 ml (95% CI, 3.2 to 41.6) greater LV end-diastolic volume and 23.2 ml (95% CI, 2.6 to 43.8) greater right ventricular end-diastolic volume in those with T2DM compared with the impact of OSA in those without T2DM. We observed a net improvement in LV end-diastolic volume of 8.7 ml (95% CI, -7.0 to 24.4). Conclusions:  The combination of T2DM plus OSA is associated with macrovascular endothelial dysfunction beyond that observed with either disease alone. CPAP for 3 months did not significantly improve macrovascular endothelial function in the intent-to-treat analysis; however, cardiovascular magnetic resonance results suggest that there may be a beneficial effect of CPAP on LV diastolic volume.Clinical trial registered with www.clinicaltrials.gov (NCT01629862).",2020,"CPAP for 3-months did not significantly improve macro-vascular endothelial function in the intent-to-treat analysis; however, CMR results suggest that there may be a beneficial effect of CPAP on LV diastolic volume.","['141 adults with T2DM, OSA, T2DM+OSA, and controls', 'Diabetes and Sleep Apnea', '53 adults with T2DM+OSA', 'type 2 diabetes mellitus (T2DM) and obstructive sleep apnea (OSA']","['T2DM and OSA', 'placebo-controlled trial comparing active and sham continuous positive airway pressure (CPAP', 'T2DM+OSA', 'OSA', 'CPAP']","['RV end-diastolic volume', 'LV end-diastolic volume', 'Vascular Function and Cardiac Structure', 'LV diastolic volume', 'LV and RV end-diastolic volume, such that OSA', 'FMD', 'Endothelium-dependent macro- and micro-vascular reactivity (flow-mediated dilation (FMD', 'vascular reactivity', 'macro-vascular endothelial function']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0014257', 'cui_str': 'Endothelium'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0031843', 'cui_str': 'function'}]",141.0,0.155195,"CPAP for 3-months did not significantly improve macro-vascular endothelial function in the intent-to-treat analysis; however, CMR results suggest that there may be a beneficial effect of CPAP on LV diastolic volume.","[{'ForeName': 'Jessie P', 'Initials': 'JP', 'LastName': 'Bakker', 'Affiliation': ""Division of Sleep & Circadian Disorders, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Baltzis', 'Affiliation': 'The Rongxiang Xu MD Center for Regenerative Therapeutics.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Tecilazich', 'Affiliation': 'The Rongxiang Xu MD Center for Regenerative Therapeutics.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Warren J', 'Initials': 'WJ', 'LastName': 'Manning', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Tomas G', 'Initials': 'TG', 'LastName': 'Neilan', 'Affiliation': 'Division of Cardiology, Department of Medicine and the Cardiovascular Imaging Research Center, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wallace', 'Affiliation': 'Department of Psychiatry and Department of Biostatistics, and.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Hudson', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, University of California, San Diego, San Diego, California.'}, {'ForeName': 'Sanjay R', 'Initials': 'SR', 'LastName': 'Patel', 'Affiliation': 'Center for Sleep and Cardiovascular Outcomes Research, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Aristidis', 'Initials': 'A', 'LastName': 'Veves', 'Affiliation': 'The Rongxiang Xu MD Center for Regenerative Therapeutics.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201905-378OC']
298,32232608,Retinal Image Slip Must Pass the Threshold for Human Vestibulo-Ocular Reflex Adaptation.,"We sought to determine whether repeated vestibulo-ocular reflex (VOR) adaptation training to increase the VOR gain (eye/head velocity) had a lasting effect in normal subjects and whether there was a retinal image slip tolerance threshold for VOR adaptation. We used the unilateral incremental VOR adaptation technique and horizontal active (self-generated, predictable) head impulses as the vestibular stimulus. Both active and passive (imposed, unpredictable) head impulse VOR gains were measured before and after unilateral incremental VOR adaptation training. The adapting side was pseudo-randomized for left or right. We tested ten normal subjects over one block (10 sessions over 12 days) of VOR adaptation training and testing, immediately followed by a second block (5 sessions over 19 days) of testing only without training. Our findings show robust short-term VOR adaptation of ~ 10 % immediately after each 15-min training session, but that the daily pre-adaptation gain was most different on days 1 and 2, and for subsequent training days before saturating to ~ 5 % greater than the pre-adaptation gain on day 1. This increase was partially retained for 19 days after regular training stopped. The data suggest that stable vision in normal subjects is maintained when there is < 5 % deviation in VOR gain from the original baseline, which corresponds to < 9°/s retinal image slip. Below this threshold, there is poor adaptive drive to return the gain to its original baseline value.",2020,"Both active and passive (imposed, unpredictable) head impulse VOR gains were measured before and after unilateral incremental VOR adaptation training.",['normal subjects'],"['VOR adaptation training and testing, immediately followed by a second block (5 sessions over 19\xa0days) of testing only without training', 'unilateral incremental VOR adaptation technique and horizontal active (self-generated, predictable) head impulses as the vestibular stimulus', 'repeated vestibulo-ocular reflex (VOR) adaptation training']","['VOR gain (eye/head velocity', 'VOR gain']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0034944', 'cui_str': 'Reflexes, Vestibo-Ocular'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]","[{'cui': 'C0034944', 'cui_str': 'Reflexes, Vestibo-Ocular'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",10.0,0.022205,"Both active and passive (imposed, unpredictable) head impulse VOR gains were measured before and after unilateral incremental VOR adaptation training.","[{'ForeName': 'M Muntaseer', 'Initials': 'MM', 'LastName': 'Mahfuz', 'Affiliation': 'Balance and Vision Laboratory, Neuroscience Research Australia, Cnr Barker Street & Easy Street Randwick, Sydney, NSW, 2031, Australia.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Schubert', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Laboratory of Vestibular NeuroAdaptation, Johns Hopkins University, Baltimore, MD, 21205, USA.'}, {'ForeName': 'William V C', 'Initials': 'WVC', 'LastName': 'Figtree', 'Affiliation': 'Balance and Vision Laboratory, Neuroscience Research Australia, Cnr Barker Street & Easy Street Randwick, Sydney, NSW, 2031, Australia.'}, {'ForeName': 'Americo A', 'Initials': 'AA', 'LastName': 'Migliaccio', 'Affiliation': 'Balance and Vision Laboratory, Neuroscience Research Australia, Cnr Barker Street & Easy Street Randwick, Sydney, NSW, 2031, Australia. a.migliaccio@neura.edu.au.'}]",Journal of the Association for Research in Otolaryngology : JARO,['10.1007/s10162-020-00751-6']
299,32014119,"Systemic chemotherapy with or without cetuximab in patients with resectable colorectal liver metastasis (New EPOC): long-term results of a multicentre, randomised, controlled, phase 3 trial.","BACKGROUND


The interim analysis of the multicentre New EPOC trial in patients with resectable colorectal liver metastasis showed a significant reduction in progression-free survival in patients allocated to cetuximab plus chemotherapy compared with those given chemotherapy alone. The focus of the present analysis was to assess the effect on overall survival.
METHODS


New EPOC was a multicentre, open-label, randomised, controlled, phase 3 trial. Adult patients (aged ≥18 years) with KRAS wild-type (codons 12, 13, and 61) resectable or suboptimally resectable colorectal liver metastases and a WHO performance status of 0-2 were randomly assigned (1:1) to receive chemotherapy with or without cetuximab before and after liver resection. Randomisation was done centrally with minimisation factors of surgical centre, poor prognosis cancer, and previous adjuvant treatment with oxaliplatin. Chemotherapy consisted of oxaliplatin 85 mg/m 2  administered intravenously over 2 h, l-folinic acid (175 mg flat dose administered intravenously over 2 h) or d,l-folinic acid (350 mg flat dose administered intravenously over 2 h), and fluorouracil bolus 400 mg/m 2  administered intravenously over 5 min, followed by a 46 h infusion of fluorouracil 2400 mg/m 2  repeated every 2 weeks (regimen one), or oxaliplatin 130 mg/m 2  administered intravenously over 2 h and oral capecitabine 1000 mg/m 2  twice daily on days 1-14 repeated every 3 weeks (regimen two). Patients who had received adjuvant oxaliplatin could receive irinotecan 180 mg/m 2  intravenously over 30 min with fluorouracil instead of oxaliplatin (regimen three). Cetuximab was given intravenously, 500 mg/m 2  every 2 weeks with regimen one and three or a loading dose of 400 mg/m 2  followed by a weekly infusion of 250 mg/m 2  with regimen two. The primary endpoint of progression-free survival was published previously. Secondary endpoints were overall survival, preoperative response, pathological resection status, and safety. Trial recruitment was halted prematurely on the advice of the Trial Steering Committee on Nov 1, 2012. All analyses (except safety) were done on the intention-to-treat population. Safety analyses included all randomly assigned patients. This trial is registered with ISRCTN, number 22944367.
FINDINGS


Between Feb 26, 2007, and Oct 12, 2012, 257 eligible patients were randomly assigned to chemotherapy with cetuximab (n=129) or without cetuximab (n=128). This analysis was carried out 5 years after the last patient was recruited, as defined in the protocol, at a median follow-up of 66·7 months (IQR 58·0-77·5). Median progression-free survival was 22·2 months (95% CI 18·3-26·8) in the chemotherapy alone group and 15·5 months (13·8-19·0) in the chemotherapy plus cetuximab group (hazard ratio [HR] 1·17, 95% CI 0·87-1·56; p=0·304). Median overall survival was 81·0 months (59·6 to not reached) in the chemotherapy alone group and 55·4 months (43·5-71·5) in the chemotherapy plus cetuximab group (HR 1·45, 1·02-2·05; p=0·036). There was no significant difference in the secondary outcomes of preoperative response or pathological resection status between groups. Five deaths might have been treatment-related (one in the chemotherapy alone group and four in the chemotherapy plus cetuximab group). The most common grade 3-4 adverse events reported were: neutrophil count decreased (26 [19%] of 134 in the chemotherapy alone group vs 21 [15%] of 137 in the chemotherapy plus cetuximab group), diarrhoea (13 [10%] vs 14 [10%]), skin rash (one [1%] vs 22 [16%]), thromboembolic events (ten [7%] vs 11 [8%]), lethargy (ten [7%] vs nine [7%]), oral mucositis (three [2%] vs 14 [10%]), vomiting (seven [5%] vs seven [5%]), peripheral neuropathy (eight [6%] vs five [4%]), and pain (six [4%] vs six [4%]).
INTERPRETATION


Although the addition of cetuximab to chemotherapy improves the overall survival in some studies in patients with advanced, inoperable metastatic disease, its use in the perioperative setting in patients with operable disease confers a significant disadvantage in terms of overall survival. Cetuximab should not be used in this setting.
FUNDING


Cancer Research UK.",2020,"Median progression-free survival was 22·2 months (95% CI 18·3-26·8) in the chemotherapy alone group and 15·5 months (13·8-19·0) in the chemotherapy plus cetuximab group (hazard ratio [HR] 1·17, 95% CI 0·87-1·56; p=0·304).","['Between Feb 26, 2007, and Oct 12, 2012', 'Adult patients (aged ≥18 years) with KRAS wild-type (codons 12, 13, and 61) resectable or suboptimally resectable colorectal liver metastases and a WHO performance status of 0-2', 'patients with resectable colorectal liver metastasis (New EPOC', 'patients with advanced, inoperable metastatic disease', 'patients with resectable colorectal liver metastasis', '257 eligible patients']","['adjuvant oxaliplatin', 'Cetuximab', 'l-folinic acid', 'irinotecan 180 mg/m 2  intravenously over 30 min with fluorouracil instead of oxaliplatin', 'cetuximab to chemotherapy', 'oxaliplatin 130 mg/m 2  administered intravenously over 2 h and oral capecitabine', 'cetuximab plus chemotherapy', 'Systemic chemotherapy with or without cetuximab', 'fluorouracil', 'oxaliplatin 85 mg/m 2  administered intravenously over 2 h, l-folinic acid', 'chemotherapy with or without cetuximab', 'chemotherapy with cetuximab (n=129) or without cetuximab', 'oxaliplatin']","['diarrhoea', 'thromboembolic events', 'Median progression-free survival', 'peripheral neuropathy', 'lethargy', 'Median overall survival', 'vomiting', 'pain', 'neutrophil count', 'preoperative response or pathological resection status', 'progression-free survival', 'skin rash', 'overall survival', 'overall survival, preoperative response, pathological resection status, and safety', 'oral mucositis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0009221', 'cui_str': 'Codon'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}]",257.0,0.335991,"Median progression-free survival was 22·2 months (95% CI 18·3-26·8) in the chemotherapy alone group and 15·5 months (13·8-19·0) in the chemotherapy plus cetuximab group (hazard ratio [HR] 1·17, 95% CI 0·87-1·56; p=0·304).","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, University College London, London, UK. Electronic address: j.bridgewater@ucl.ac.uk.'}, {'ForeName': 'Siân A', 'Initials': 'SA', 'LastName': 'Pugh', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Maishman', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Zina', 'Initials': 'Z', 'LastName': 'Eminton', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Mellor', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Whitehead', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Stanton', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Radford', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Corkhill', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Gareth O', 'Initials': 'GO', 'LastName': 'Griffiths', 'Affiliation': 'Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Cancer Institute, Bristol, UK.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences/The Christie NHS Foundation Trust, University of Manchester, Manchester, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': 'Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Ajith K', 'Initials': 'AK', 'LastName': 'Siriwardena', 'Affiliation': 'Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Hornbuckle', 'Affiliation': 'Sheffield Teaching Hospital NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Myrddin', 'Initials': 'M', 'LastName': 'Rees', 'Affiliation': 'Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Iveson', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Hickish', 'Affiliation': 'Dorset Cancer Centre/Bournemouth University, Bournemouth, UK.'}, {'ForeName': 'O James', 'Initials': 'OJ', 'LastName': 'Garden', 'Affiliation': 'Clinical Surgery, University of Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Maughan', 'Affiliation': 'MRC Oxford Institute for Radiation Oncology, Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Primrose', 'Affiliation': 'Department of Surgery, University of Southampton, Southampton, UK. Electronic address: j.n.primrose@soton.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30798-3']
300,31728054,Randomized assessment of delayed intensification and two methods for parenteral methotrexate delivery in childhood B-ALL: Children's Oncology Group Studies P9904 and P9905.,"The delayed intensification (DI) enhanced outcome for patients with acute lymphoblastic leukemia (ALL) treated on BFM 76/79 and CCG 105 after a prednisone-based induction. Childrens Oncology Group protocols P9904/9905 evaluated DI via a post-induction randomization for eligible National Cancer Institute (NCI) standard (SR) and high-risk (HR) patients. A second randomization compared intravenous methotrexate (IV MTX) as a 24- (1 g/m 2 ) vs. 4-h (2 g/m 2 ) infusion. NCI SR patients received a dexamethasone-based three-drug and NCI HR/CNS 3 SR patients a prednisone-based four-drug induction. End induction MRD (minimal residual disease) was obtained but did not impact treatment. DI improved the 10-year continuous complete remission (CCR) rate; 75.5 ± 2.5% vs. 81.8 ± 2.2% p = 0.002, whereas MTX administration did not; 4-h 80.8 ± 1.9%; 24-h 81.4 ± 1.9% (p = 0.7780). Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209). MRD predicted outcome; 10-year CCR 87.7 ± 2.2 and 82.1 ± 2.5% when MRD was <0.01% with/without DI (p = 0.007) and 54.3 ± 8% and 44 ± 8% for patients with MRD ≥ 0.01% with/without DI (p = 0.11). DI improved CCR for patients with B-ALL with and without end induction MRD.",2020,Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209).,"['eligible National Cancer Institute (NCI) standard (SR) and high-risk (HR) patients', 'Childrens Oncology Group protocols', ""childhood B-ALL: Children's Oncology Group Studies P9904 and P9905"", 'patients with acute lymphoblastic leukemia (ALL) treated on']","['NCI SR', 'dexamethasone', 'MTX', 'BFM', 'intravenous methotrexate (IV MTX']","['Overall survival (OS', 'DI improved CCR', '10-year continuous complete remission']","[{'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.0328713,Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209).,"[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA. naomi.winick@utsouthwestern.edu.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Martin', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shuster', 'Affiliation': 'Department of Health Outcomes and Policy, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology and Oncology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Paul Bowman', 'Affiliation': 'Department of Pediatrics, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Larsen', 'Affiliation': ""Maine Children's Cancer Program, Scarborough, ME, USA.""}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Pullen', 'Affiliation': 'Department of Pediatrics, University of Mississippi, Jackson, MS, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Willman', 'Affiliation': 'Cancer Center and Departments of Internal Medicine and Pathology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and the Center for Childhood Cancer Research, Children's Hospital of Philadelphia, and the Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics and The Perlmutter Cancer Center, New York University Medical Center, New York, NY, USA.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Camitta', 'Affiliation': 'Department of Pediatrics, Midwest Center for Cancer and Blood Disorders, Medical College of Wisconsin, Milwaukee, WI, USA.'}]",Leukemia,['10.1038/s41375-019-0642-2']
301,31447237,"Real-Time Contrast-Enhanced-Guided Biopsy Compared with Conventional Ultrasound-Guided Biopsy in the Diagnosis of Hepatic Tumors on a Background of Advanced Chronic Liver Disease: A Prospective, Randomized, Clinical Trial.","We aimed to compare contrast-enhanced-guided liver biopsy (CEUSLB) and ultrasound-guided liver biopsy (USLB) in the diagnosis of focal liver lesions (FLLs) developed on a background of advanced chronic liver disease (ACLD). Between 2011 and 2019, patients diagnosed with liver tumors on a background of ACLD were evaluated for inclusion in the study. Patients were randomly assigned to the CEUSLB or USLB group. In total, 144 patients were randomly assigned to either CEUSLB (n = 79) or USLB (n = 65). Overall, in the CEUSLB group, the sensitivity was significantly better (94.74% vs. 74.6%, respectively; p = 0.001). Both the fragment length of the biopsy specimen and the single puncture success rate were statistically higher in the CEUSLB group (p = 0.022 and p = 0.0006, respectively). There was no difference in terms of major or minor complications (p = 0.682). CEUSLB is a feasible technique that increases the diagnostic sensitivity for liver tumors developed in ACLD.",2019,"Both the fragment length of the biopsy specimen and the single puncture success rate were statistically higher in the CEUSLB group (p = 0.022 and p = 0.0006, respectively).","['Between 2011 and 2019, patients diagnosed with liver tumors on a background of ACLD were evaluated for inclusion in the study', 'advanced chronic liver disease (ACLD', '144 patients']","['Real-Time Contrast-Enhanced-Guided Biopsy Compared with Conventional Ultrasound-Guided Biopsy', 'CEUSLB', 'contrast-enhanced-guided liver biopsy (CEUSLB) and ultrasound-guided liver biopsy (USLB', 'CEUSLB or USLB', 'USLB']","['major or minor complications', 'sensitivity', 'single puncture success rate', 'diagnostic sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023903', 'cui_str': 'Neoplasms, Hepatic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0860197', 'cui_str': 'Advanced chronic liver disease'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0456900', 'cui_str': 'Ultrasound guided biopsy (procedure)'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver (procedure)'}, {'cui': 'C0860886', 'cui_str': 'Ultrasound guided liver biopsy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",144.0,0.0766567,"Both the fragment length of the biopsy specimen and the single puncture success rate were statistically higher in the CEUSLB group (p = 0.022 and p = 0.0006, respectively).","[{'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Sparchez', 'Affiliation': '3rd Medical Department, Institute for Gastroenterology and Hepatology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Mocan', 'Affiliation': '3rd Medical Department, Institute for Gastroenterology and Hepatology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania. Electronic address: mocan_tudor@yahoo.com.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hagiu', 'Affiliation': '3rd Medical Department, Institute for Gastroenterology and Hepatology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Kacso', 'Affiliation': 'Department of Medical Oncology and Radiotherapy, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Toader', 'Initials': 'T', 'LastName': 'Zaharie', 'Affiliation': '3rd Pathology Department, Institute for Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Rusu', 'Affiliation': '3rd Pathology Department, Institute for Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Nadim', 'Initials': 'N', 'LastName': 'Al Hajjar', 'Affiliation': '3rd Surgical Department, Institute for Gastroenterology and Hepatology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Daniel Corneliu', 'Initials': 'DC', 'LastName': 'Leucuta', 'Affiliation': 'Medical Informatics and Biostatistics Department, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Sparchez', 'Affiliation': ""Iuliu Hatieganu University of Medicine and Pharmacy, 2nd Paediatric Clinic, Children's Hospital at Cluj-Napoca, Cluj-Napoca, Romania.""}]",Ultrasound in medicine & biology,['10.1016/j.ultrasmedbio.2019.07.678']
302,31174929,A pilot study of mindful body awareness training as an adjunct to office-based medication treatment of opioid use disorder.,"The purpose of this study was to pilot-test a mind-body intervention called Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to buprenorphine for individuals with opioid use disorder (OUD). MABT, a manualized 8 week protocol, teaches interoceptive awareness skills to promote self-care and emotion regulation. A small study was designed to assess MABT recruitment and retention feasibility, and intervention acceptability, among this population. Individuals were recruited from two office-based programs providing buprenorphine treatment within a large urban community medical center. Participants were randomized to receive either treatment as usual (TAU), or TAU plus MABT. Assessments administered at baseline and 10-week follow-up included validated self-report health questionnaires and a process measure, the Multidimensional Assessment of Interoceptive Awareness, to examine interoceptive awareness skills. An additional survey and exit interview for those in the MABT study arm were administered to assess intervention satisfaction. Results showed the ability to recruit and enroll 10 participants within two-weeks, and no loss to follow-up. The MABT study group showed an increase in interoceptive awareness skills from baseline to follow-up, whereas the control group did not. Responses to the satisfaction questionnaire and exit interview were positive, indicating skills learned, satisfaction with the interventionists, and overall perceived benefit of the intervention. In summary, study results demonstrated recruitment and retention feasibility, and high intervention acceptability. This pilot study suggests preliminary feasibility of successfully implementing a larger study of MABT as an adjunct to office-based medication treatment for opioid use disorder.",2020,Individuals were recruited from two office-based programs providing buprenorphine treatment within a large urban community medical center.,"['treatment within a large urban community medical center', 'individuals with opioid use disorder (OUD']","['mind-body intervention called Mindful Awareness in Body-oriented Therapy (MABT', 'buprenorphine', 'usual (TAU), or TAU plus MABT', 'mindful body awareness training', 'MABT']","['MABT recruitment and retention feasibility, and intervention acceptability', 'interoceptive awareness skills']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C1562642', 'cui_str': 'Community medical center'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",10.0,0.0286996,Individuals were recruited from two office-based programs providing buprenorphine treatment within a large urban community medical center.,"[{'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Price', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington, Box 357266, Seattle, WA 98195, USA. Electronic address: cynthiap@uw.edu.'}, {'ForeName': 'Joseph O', 'Initials': 'JO', 'LastName': 'Merrill', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Harborview Medical Center, 325 Ninth Ave, Seattle, WA 98195, USA.'}, {'ForeName': 'Rachelle L', 'Initials': 'RL', 'LastName': 'McCarty', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington, Box 357266, Seattle, WA 98195, USA.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Pike', 'Affiliation': 'Department of Psychosocial and Community Health Nursing, University of Washington, Box 357263, Seattle, WA 98185, USA.'}, {'ForeName': 'Judith I', 'Initials': 'JI', 'LastName': 'Tsui', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Harborview Medical Center, 325 Ninth Ave, Seattle, WA 98195, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.05.013']
303,32242241,Comment on Li et al.: Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study.,,2020,,['high tibial osteotomy'],[' Drainage relieves pain without increasing post-operative blood loss'],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",[],,0.0521105,,"[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'The Third Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China. helloyh2008@126.com.'}]",International orthopaedics,['10.1007/s00264-020-04555-4']
304,32242987,Effects of Palmaria palmata on lipid metabolism and glycemic control in participants with hypercholesterolemia in a randomized double-blind placebo-controlled trial.,"BACKGROUND


Red algae have been reported to improve lipid and glucose metabolism in rats. We investigated the effects of Palmaria palmata (P. palmata), a red alga from northern Japan, on lipid metabolism and glycemic control in participants with hypercholesterolemia.
METHODS


We conducted an 8-week, randomized, double-blind, placebo-controlled, and parallel-group comparison trial. The study enrolled Japanese participants with a serum low-density protein cholesterol (LDL-C) ≥120 mg/dL. The participants were randomly assigned to take either capsules containing P. palmata (2 g/day) or placebo capsules. The primary endpoint was the change in LDL-C from baseline to week 8 and the secondary endpoints were the changes in other lipid parameters and glycemic control.
RESULTS


Of the 104 participants completed the study protocol. There were no significant differences in change in LDL-C, body mass index, waist circumference, or glycemic control between the two groups. However, serum triglyceride showed significantly greater improvement in women in the P. palmata group (-9.0 [-25.0, +5.0]) vs. those in the placebo group (-1.0 [-11.0, +19.0]; p = .03).
CONCLUSIONS


The present study did not show that P. palmata had significant effect on serum LDL-C nor glycemic control, but hypertriglyceridemia could be ameliorated by administration of P. palmata in women.",2020,"There were no significant differences in change in LDL-C, body mass index, waist circumference, or glycemic control between the two groups.","['104 participants completed the study protocol', 'enrolled Japanese participants with a serum low-density protein cholesterol (LDL-C', 'participants with hypercholesterolemia', 'rats']","['placebo capsules', 'Palmaria palmata', 'Palmaria palmata (P. palmata', 'capsules containing P. palmata', 'placebo']","['serum triglyceride', 'LDL-C, body mass index, waist circumference, or glycemic control', 'lipid parameters and glycemic control', 'change in LDL-C', 'lipid and glucose metabolism', 'lipid metabolism and glycemic control', 'serum LDL-C nor glycemic control, but hypertriglyceridemia']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}]",104.0,0.633972,"There were no significant differences in change in LDL-C, body mass index, waist circumference, or glycemic control between the two groups.","[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Takase', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Minori', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'Department of Psychiatry, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Atsuhito', 'Initials': 'A', 'LastName': 'Toyomaki', 'Affiliation': 'Department of Psychiatry, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Kusumi', 'Affiliation': 'Department of Psychiatry, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Rikako', 'Initials': 'R', 'LastName': 'Kino', 'Affiliation': 'Regional Collaboration Department, Institute for the Promotion of Business-Regional Collaboration, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Konishi', 'Affiliation': 'Hokkaido Industrial Technology Center, Hakodate, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kiso', 'Affiliation': 'Regional Collaboration Department, Institute for the Promotion of Business-Regional Collaboration, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}]",Phytotherapy research : PTR,['10.1002/ptr.6680']
305,32243009,"Supplementation with Cynanchum wilfordii radix extract for 8 weeks lowers serum total cholesterol: A controlled, randomized, double-blind clinical trial.","This trial aimed to determine the effect of a standardized Cynanchum wilfordii Radix extract (CWE) on the lipid profiles of individuals with elevated total cholesterol (T-Chol) using a double-blind randomized placebo-controlled design. Ninety-six Korean individuals with elevated T-Chol level (200-240 mg/dL) were recruited and randomly allocated to groups that received VasH300 (300 mg CWE/day, n = 32), VasH600 (600 mg CWE/day, n = 32), or a placebo (n = 32) groups. Primary outcomes included T-Chol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, triglyceride, and safety (adverse events, biochemical parameters, and hematological parameters). Data were compared using a one-way analysis of variance followed by Duncan's post-hoc tests (among groups) and paired t tests (within groups). Values for T-Chol and LDL-cholesterol were significantly reduced in the VasH300 and groups (VasH300: 4.0 and 6.4%, respectively; VasH600; 3.8 and 5.8% respectively; both p < .05) compared with the placebo group and were not dose-dependent. VasH300 significantly improved the lipid profiles of individuals with elevated T-Chol without any serious side effects. Daily supplementation with VasH might be an alternative strategy with which to modify cholesterol-related parameters, especially in individuals with elevated T-Chol levels.",2020,"Values for T-Chol and LDL-cholesterol were significantly reduced in the VasH300 and groups (VasH300: 4.0 and 6.4%, respectively; VasH600; 3.8 and 5.8% respectively; both p < .05) compared with the placebo group and were not dose-dependent.","['individuals with elevated total cholesterol (T-Chol', 'Ninety-six Korean individuals with elevated T-Chol level (200-240\u2009mg/dL']","['placebo', 'VasH300', 'standardized Cynanchum wilfordii Radix extract (CWE', 'Cynanchum wilfordii radix extract']","['serum total cholesterol', 'Values for T-Chol and LDL-cholesterol', 'lipid profiles', 'T-Chol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, triglyceride, and safety (adverse events, biochemical parameters, and hematological parameters']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0331145', 'cui_str': 'Cynanchum'}, {'cui': 'C0242726', 'cui_str': 'Plant roots'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",96.0,0.58115,"Values for T-Chol and LDL-cholesterol were significantly reduced in the VasH300 and groups (VasH300: 4.0 and 6.4%, respectively; VasH600; 3.8 and 5.8% respectively; both p < .05) compared with the placebo group and were not dose-dependent.","[{'ForeName': 'Seon Mi', 'Initials': 'SM', 'LastName': 'Shin', 'Affiliation': 'Department of Korean Internal Medicine, College of Korean Medicinem, Semyung University, Jecheon, Republic of Korea.'}, {'ForeName': 'Young Mi', 'Initials': 'YM', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Research, Research Mentor Co. Ltd., Seoul, Republic of Korea.'}, {'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Kwon', 'Affiliation': 'Department of Oriental Medicine Biotechnology, College of Life Sciences, Kyung Hee University, Yongin, Republic of Korea.'}, {'ForeName': 'Sung Ryul', 'Initials': 'SR', 'LastName': 'Lee', 'Affiliation': 'Department of Convergence Biomedical Science, Cardiovascular and Metabolic Disease Cencer, College of Medicine, Inje University, Busan, Republic of Korea.'}, {'ForeName': 'Se Chan', 'Initials': 'SC', 'LastName': 'Kang', 'Affiliation': 'Department of Oriental Medicine Biotechnology, College of Life Sciences, Kyung Hee University, Yongin, Republic of Korea.'}]",Phytotherapy research : PTR,['10.1002/ptr.6682']
306,31879812,The antifibrinolytic and anti-inflammatory effects of a high initial-dose tranexamic acid in total knee arthroplasty: a randomized controlled trial.,"PURPOSE


The aim of this study was to evaluate the effects of a high initial-dose (60 mg/kg) intravenous tranexamic acid (IV-TXA) on fibrinolysis and inflammation after total knee arthroplasty (TKA).
METHODS


A total of 132 patients were categorized into two groups based on different TXA regimens: 20 mg/kg before incision (A) or 60 mg/kg before incision (B). All patients received five doses of 1 g TXA at three, six, 12, 18, and 24 hours after the first dose. The primary outcomes were peri-operative blood loss and transfusion rate. Other outcome measurements such as, haemoglobin level, fibrinolysis parameters [fibrin(-ogen) degradation products (FDP), D-dimer], inflammatory factors [C-reactive protein (CRP), interleukin-6 (IL-6)], visual analog scale (VAS) score, consumption of analgesic rescue, coagulation parameters [activated partial thromboplastin time (APTT), prothrombin time (PT), platelet count, thrombelastography (TEG), and anti-factor Xa activity (AFXa)] and complications, were also compared.
RESULTS


There was a favourable effect in reducing peri-operative blood loss and transfusion rate for patients in Group B, compared with patients in Group A. In addition, the levels of FDP, D-dimer, CRP, IL-6, and dynamic pain in Group B were significantly lower than those in Group A on post-operative days one, two and three. There were no statistically significant differences in postoperative coagulation parameters and complications between the two groups.
CONCLUSION


A high initial-dose (60 mg/kg) IV-TXA before surgery followed by five doses can further reduce blood loss, provide additional fibrinolysis and inflammation control, and ameliorate post-operative pain following TKA, without increasing the risk of treatment-related complications.",2020,"There was a favourable effect in reducing peri-operative blood loss and transfusion rate for patients in Group B, compared with patients in Group A.","['after total knee arthroplasty (TKA', 'total knee arthroplasty', '132 patients']","['high initial-dose (60\xa0mg/kg) intravenous tranexamic acid (IV-TXA', 'TXA regimens: 20\xa0mg/kg before incision (A) or 60\xa0mg/kg before incision (B', 'tranexamic acid']","['levels of FDP, D-dimer, CRP, IL-6, and dynamic pain', 'haemoglobin level, fibrinolysis parameters [fibrin(-ogen) degradation products (FDP), D-dimer], inflammatory factors [C-reactive protein (CRP), interleukin-6 (IL-6)], visual analog scale (VAS) score, consumption of analgesic rescue, coagulation parameters [activated partial thromboplastin time (APTT), prothrombin time (PT), platelet count, thrombelastography (TEG), and anti-factor Xa activity (AFXa)] and complications', 'blood loss', 'postoperative coagulation parameters and complications', 'peri-operative blood loss and transfusion rate', 'fibrinolysis and inflammation']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0294942', 'cui_str': '(18F)FDP'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0722236', 'cui_str': 'Ogen'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",132.0,0.1163,"There was a favourable effect in reducing peri-operative blood loss and transfusion rate for patients in Group B, compared with patients in Group A.","[{'ForeName': 'Yi-Ting', 'Initials': 'YT', 'LastName': 'Lei', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, No.1 Youyi Road, Yuzhong District, Chongqing, 400016, People's Republic of China.""}, {'ForeName': 'Jin-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Chongqing Medical University, No.1 Youyi Road, Yuzhong District, Chongqing, 400016, People's Republic of China. huangw511@163.com.""}, {'ForeName': 'Fu-Xing', 'Initials': 'FX', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopedics, West China Hospital, Sichuan University, 37# WainanGuoxue Road, Chengdu, 610041, People's Republic of China. peifux@126.com.""}]",International orthopaedics,['10.1007/s00264-019-04469-w']
307,30664661,Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.,"BACKGROUND/OBJECTIVES


Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo.
SUBJECTS/METHODS


Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively.
RESULTS


Baseline characteristics and comorbidities were comparable for placebo (n = 1515) and NB (n = 2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P < 0.001), anxiety (5.4 vs 3.3%, P = 0.029), and depression (1.8 vs 2.7%, P = 0.014); PAEs were more frequent during dose escalation and generally mild or moderate. Mean (SD) changes in IDS-SR total score from baseline to endpoint were small in both groups: 0.13 (5.83) for NB and -0.45 (5.65) for placebo. Retrospective AE categorization via C-CASA confirmed no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior.
CONCLUSIONS


This large pooled analysis of 5 clinical trials provides additional safety information about the NB PAE profile. Anxiety and sleep disorder-related PAEs were more frequent with NB versus placebo but were mostly mild to moderate and generally occurred early. Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",2019,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",['subjects with overweight or obesity'],"['naltrexone/bupropion combination therapy', 'bupropion 360\u2009mg (NB', 'placebo']","['Depression-related PAEs', 'depression', 'suicidal ideation or behavior', 'Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively', 'Psychiatric adverse events', 'Mean (SD) changes in IDS-SR total score', 'Anxiety and sleep disorder-related PAEs', 'anxiety', 'sleep disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002045'}, {'cui': 'C3494753', 'cui_str': 'Suicide evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]",,0.497082,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Boston University School of Medicine and Department of Medicine Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, and Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Annexon Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Lisette M', 'Initials': 'LM', 'LastName': 'Acevedo', 'Affiliation': 'Nalpropion Pharmaceuticals, Inc, La Jolla, CA, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA. frank.greenway@pbrc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0302-z']
308,32147182,"Ultralong administration of gonadotropin-releasing hormone agonists before in vitro fertilization improves fertilization rate but not clinical pregnancy rate in women with mild endometriosis: a prospective, randomized, controlled trial.","OBJECTIVE


To evaluate the effects of gonadotropin-releasing hormone agonists (GnRH-a) on fertility in women with mild endometriosis who are undergoing in vitro fertilization and embryo transfer (IVF-ET) procedures.
DESIGN


Prospective, randomized, controlled trial.
SETTING


Three tertiary university hospitals.
PATIENT(S)


Four hundred infertile women with mild endometriosis, documented with laparoscopy, undergoing IVF and 200 women with tubal factor infertility.
INTERVENTION(S)


Administration of GnRH-a for 3 months before an IVF attempt (group A, n = 200) or IVF without GnRH-a (group B, n = 200).
MAIN OUTCOME MEASURE(S)


Follicular fluid (FF) levels of tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), IL-6, IL-8, and IL-1 receptor antagonist; fertilization rate (FR), implantation rate (IR), quality of embryos, and clinical pregnancy rate (PR).
RESULT(S)


Women who received GnRH-a had a statistically significantly reduced concentration of FF cytokines compared with women who did not receive this regimen. Women in group B had a reduced FR (61.7; 95% CI, 59.20-64.20) compared with the women in group A (72.7; 95% CI, 70.50-74.90) and compared with the women with tubal factor infertility (74.7; 95% CI, 72.00-77.24). The embryo quality, IR, and clinical PR showed no statistically significant improvement in the women of group A compared with group B.
CONCLUSION(S)


Women who received GnRH-a for 3 months had a lower concentration of FF cytokines. These women had also a higher FR than the women who did not receive GnRH-a. However, the IR, embryo quality, and clinical PR showed no statistically significant difference when comparing the two groups. CLINICALTRIALS.
GOV ID


NCT01269125.",2020,"The embryo quality, IR, and clinical PR showed no statistically significant improvement in the women of group A compared with group B.
CONCLUSION(S)


Women who received GnRH-a for 3 months had a lower concentration of FF cytokines.","['Three tertiary university hospitals', 'women with mild endometriosis who are undergoing in\xa0vitro fertilization and embryo transfer (IVF-ET) procedures', 'Four hundred infertile women with mild endometriosis, documented with laparoscopy, undergoing IVF and 200 women with tubal factor infertility', 'women with mild endometriosis']","['gonadotropin-releasing hormone agonists (GnRH-a', 'IVF without GnRH-a', 'gonadotropin-releasing hormone agonists']","['embryo quality, IR, and clinical PR', 'fertilization rate', 'reduced FR', 'IR, embryo quality, and clinical PR', 'Follicular fluid (FF) levels of tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), IL-6, IL-8, and IL-1 receptor antagonist; fertilization rate (FR), implantation rate (IR), quality of embryos, and clinical pregnancy rate (PR', 'concentration of FF cytokines', 'tubal factor infertility']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0063710', 'cui_str': 'Receptors, IL-1'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}]",400.0,0.41086,"The embryo quality, IR, and clinical PR showed no statistically significant improvement in the women of group A compared with group B.
CONCLUSION(S)


Women who received GnRH-a for 3 months had a lower concentration of FF cytokines.","[{'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Kaponis', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Patras University, Patras, Greece. Electronic address: kaponisapostolos@hotmail.com.'}, {'ForeName': 'Grigoris', 'Initials': 'G', 'LastName': 'Chatzopoulos', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Ioannina University, Ioannina, Greece.'}, {'ForeName': 'Minas', 'Initials': 'M', 'LastName': 'Paschopoulos', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Ioannina University, Ioannina, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Georgiou', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Ioannina University, Ioannina, Greece.'}, {'ForeName': 'Vaggelis', 'Initials': 'V', 'LastName': 'Paraskevaidis', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Ioannina University, Ioannina, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Zikopoulos', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Ioannina University, Ioannina, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tsiveriotis', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Patras University, Patras, Greece.'}, {'ForeName': 'Fuminori', 'Initials': 'F', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Tottori University, Yonago, Japan.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Adonakis', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Patras University, Patras, Greece.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Tottori University, Yonago, Japan.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.12.018']
309,32219359,Effect of Apabetalone Added to Standard Therapy on Major Adverse Cardiovascular Events in Patients With Recent Acute Coronary Syndrome and Type 2 Diabetes: A Randomized Clinical Trial.,"Importance


Bromodomain and extraterminal proteins are epigenetic regulators of gene transcription. Apabetalone is a selective bromodomain and extraterminal protein inhibitor targeting bromodomain 2 and is hypothesized to have potentially favorable effects on pathways related to atherothrombosis. Pooled phase 2 data suggest favorable effects on clinical outcomes.
Objective


To test whether apabetalone significantly reduces major adverse cardiovascular events.
Design, Setting, and Participants


A randomized, double-blind, placebo-controlled trial, conducted at 190 sites in 13 countries. Patients with an acute coronary syndrome in the preceding 7 to 90 days, type 2 diabetes, and low high-density lipoprotein cholesterol levels were eligible for enrollment, which started November 11, 2015, and ended July 4, 2018, with end of follow-up on July 3, 2019.
Interventions


Patients were randomized (1:1) to receive apabetalone, 100 mg orally twice daily (n = 1215), or matching placebo (n = 1210) in addition to standard care.
Main Outcomes and Measures


The primary outcome was a composite of time to the first occurrence of cardiovascular death, nonfatal myocardial infarction, or stroke.
Results


Among 2425 patients who were randomized (mean age, 62 years; 618 women [25.6%]), 2320 (95.7%) had full ascertainment of the primary outcome. During a median follow-up of 26.5 months, 274 primary end points occurred: 125 (10.3%) in apabetalone-treated patients and 149 (12.4%) in placebo-treated patients (hazard ratio, 0.82 [95% CI, 0.65-1.04]; P = .11). More patients allocated to apabetalone than placebo discontinued study drug (114 [9.4%] vs 69 [5.7%]) for reasons including elevations of liver enzyme levels (35 [2.9%] vs 11 [0.9%]).
Conclusions and Relevance


Among patients with recent acute coronary syndrome, type 2 diabetes, and low high-density lipoprotein cholesterol levels, the selective bromodomain and extraterminal protein inhibitor apabetalone added to standard therapy did not significantly reduce the risk of major adverse cardiovascular events.
Trial Registration


ClinicalTrials.gov Identifier: NCT02586155.",2020,"More patients allocated to apabetalone than placebo discontinued study drug (114 [9.4%] vs 69 [5.7%]) for reasons including elevations of liver enzyme levels (35 [2.9%] vs 11 [0.9%]).
","['2425 patients who were randomized (mean age, 62 years; 618 women [25.6%]), 2320 (95.7%) had full ascertainment of the primary outcome', 'controlled trial, conducted at 190 sites in 13 countries', 'Patients', 'patients with recent acute coronary syndrome, type 2 diabetes', 'Patients with an acute coronary syndrome in the preceding 7 to 90 days, type 2 diabetes, and low high-density lipoprotein cholesterol levels were eligible for enrollment, which started November 11, 2015, and ended July 4, 2018, with end of follow-up on July 3, 2019']","['apabetalone, 100 mg orally twice daily (n\u2009=\u20091215), or matching placebo', 'Apabetalone Added to Standard Therapy', 'placebo']","['composite of time to the first occurrence of cardiovascular death, nonfatal myocardial infarction, or stroke', 'elevations of liver enzyme levels', 'Major Adverse Cardiovascular Events', 'major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1287351', 'cui_str': 'Finding of liver enzyme levels (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",2425.0,0.633565,"More patients allocated to apabetalone than placebo discontinued study drug (114 [9.4%] vs 69 [5.7%]) for reasons including elevations of liver enzyme levels (35 [2.9%] vs 11 [0.9%]).
","[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Buhr', 'Affiliation': 'Statistical Data Analysis Center, University of Wisconsin-Madison.'}, {'ForeName': 'Henry N', 'Initials': 'HN', 'LastName': 'Ginsberg', 'Affiliation': 'Irving Institute for Clinical and Translational Research, Columbia University, New York, New York.'}, {'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Johansson', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Kalantar-Zadeh', 'Affiliation': 'Division of Nephrology and Hypertension, University of California-Irvine.'}, {'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Kulikowski', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Toth', 'Affiliation': 'CGH Medical Center, Sterling, Illinois, and Cicarrone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wong', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sweeney', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.3308']
310,31174514,Promoting early autism detection and intervention in underserved communities: study protocol for a pragmatic trial using a stepped-wedge design.,"BACKGROUND


Despite the known benefits of early, specialized intervention for toddlers with Autism Spectrum Disorder (ASD), access to such intervention remains limited. This pragmatic trial examines a novel healthcare delivery model (Screen-Refer-Treat [SRT]), which capitalizes upon existing health care and early intervention (EI) infrastructure to increase community capacity for ASD detection and treatment before age 3, when it is likely to have the greatest impact. This model comprises three components: (1) universal use of Stage 1 ASD screening by primary care providers (PCPs) at 18-month well-child visits (i.e., Screen); (2) immediate referral of positive screens to a community-based EI program (i.e., Refer); and (3) provision of an inexpensive, evidence-based ASD-specialized treatment by EI providers, after verifying ASD risk with a Stage 2 screen (i.e., Treat). This paper describes our research design and the initial successes, challenges, and adaptations made during the early implementation phase.
METHOD/DESIGN


A stepped-wedge cluster RCT was used to implement the SRT model sequentially in four diverse Washington State counties (""clusters""). Counties are randomly assigned to the time of receipt of the SRT intervention, which comprises training workshops and technical assistance focused on the use of evidence-based ASD screening and intervention tools. Separate cohorts of families with toddlers (16-35 months old) with and without ASD concerns are recruited before and after the SRT intervention from participating PCP practices and EI programs. PCPs and EI providers complete measures on their screening, referral, and intervention practices before and after the SRT intervention. Each family cohort completes surveys about their well-being, parenting efficacy, health care satisfaction, and toddler's social-communicative behaviors.
CONCLUSION


This trial is the first of its kind to work simultaneously with two service delivery systems with the goal of improving early detection and treatment for ASD. Our approach was successful in attaining buy-in from PCPs and EI providers, building and maintaining partnerships with providers, and achieving high levels of retention and survey completion. Fostering provider engagement and problem-solving issues together as partners were integral to overcoming the main challenges. Numerous lessons have been learned thus far, which have applicability for implementation researchers in ASD and those in other fields.
TRIAL REGISTRATION


The registration number for this trial is NCT02409303 and it was posted on ClinicalTrials.gov on April 6, 2015.",2019,"PCPs and EI providers complete measures on their screening, referral, and intervention practices before and after the SRT intervention.","['four diverse Washington State counties (""clusters', 'Separate cohorts of families with toddlers (16-35\u2009months old) with and without ASD concerns are recruited before and after the SRT intervention from participating PCP practices and EI programs', 'toddlers with Autism Spectrum Disorder (ASD', 'underserved communities']","['SRT intervention, which comprises training workshops and technical assistance focused on the use of evidence-based ASD screening and intervention tools', 'Stage 1 ASD screening by primary care providers (PCPs) at 18-month well-child visits (i.e., Screen); (2) immediate referral of positive screens to a community-based EI program (i.e., Refer); and (3) provision of an inexpensive, evidence-based ASD-specialized treatment by EI providers', 'novel healthcare delivery model (Screen-Refer-Treat [SRT']",[],"[{'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C1444729', 'cui_str': 'Well child visit, 18 month'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011211', 'cui_str': 'Delivery of Healthcare'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]",[],,0.0753506,"PCPs and EI providers complete measures on their screening, referral, and intervention practices before and after the SRT intervention.","[{'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Ibañez', 'Affiliation': 'Department of Psychology, University of Washington, CHDD, Box 357920, Seattle, WA, 98195, USA. libanez1@uw.edu.'}, {'ForeName': 'Ann Vander', 'Initials': 'AV', 'LastName': 'Stoep', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Department of Epidemiology, University of Washington, Seattle, WA, 98195, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Myers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, 98195, USA.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Washington, Seattle, WA, 98195, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dorsey', 'Affiliation': 'Department of Psychology, University of Washington, CHDD, Box 357920, Seattle, WA, 98195, USA.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Steinman', 'Affiliation': 'Departments of Neurology, Psychiatry & Behavioral Sciences, and Pediatrics, University of Washington, Seattle, WA, 98195, USA.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Stone', 'Affiliation': 'Department of Psychology, University of Washington, CHDD, Box 357920, Seattle, WA, 98195, USA.'}]",BMC psychiatry,['10.1186/s12888-019-2150-3']
311,30668322,"Artemisia annua and Artemisia afra tea infusions vs. artesunate-amodiaquine (ASAQ) in treating Plasmodium falciparum malaria in a large scale, double blind, randomized clinical trial.","BACKGROUND AND OBJECTIVE


Prior small-scale clinical trials showed that Artemisia annua and Artemisia afra infusions, decoctions, capsules, or tablets were low cost, easy to use, and efficient in curing malaria infections. In a larger-scale trial in Kalima district, Democratic Republic of Congo, we aimed to show A. annua and/or A. afra infusions were superior or at least equivalent to artesunate-amodiaquine (ASAQ) against malaria.
METHODS


A double blind, randomized clinical trial with 957 malaria-infected patients had two treatment arms: 472 patients for ASAQ and 471 for Artemisia (248 A. annua, 223 A. afra) remained at end of the trial. ASAQ-treated patients were treated per manufacturer posology, and Artemisia-treated patients received 1 l/d of dry leaf/twig infusions for 7 d; both arms had 28 d follow-up. Parasitemia and gametocytes were measured microscopically with results statistically compared among arms for age and gender.
RESULTS


Artemisinin content of A. afra was negligible, but therapeutic responses of patients were similar to A. annua-treated patients; trophozoites cleared after 24  h, but took up to 14 d to clear in ASAQ-treated patients. D28 cure rates defined as absence of parasitemia were for pediatrics 82, 91, and 50% for A. afra, A. annua and ASAQ; while for adults cure rates were 91, 100, and 30%, respectively. Fever clearance took 48  h for ASAQ, but 24  h for Artemisia. From D14-28 no Artemisia-treated patients had microscopically detectable gametocytes, while 10 ASAQ-treated patients remained gametocyte carriers at D28. More females than males were gametocyte carriers in the ASAQ arm but were unaffected in the Artemisia arms. Hemoglobin remained constant at 11 g/dl for A. afra after D1, while for A. annua and ASAQ it decreased to 9-9.5  g/dl. Only 5.0% of Artemisia-treated patients reported adverse effects, vs. 42.8% for ASAQ.
CONCLUSION


A. annua and A. afra infusions are polytherapies with better outcomes than ASAQ against malaria. In contrast to ASAQ, both Artemisias appeared to break the cycle of malaria by eliminating gametocytes. This study merits further investigation for possible inclusion of Artemisia tea infusions as an alternative for fighting and eradicating malaria.",2019,"Only 5.0% of Artemisia-treated patients reported adverse effects, vs. 42.8% for ASAQ.
","['957 malaria-infected patients had two treatment arms: 472 patients for ASAQ and 471 for Artemisia (248 A. annua, 223 A. afra) remained at end of the trial']","['Artemisia annua and Artemisia afra tea infusions vs. artesunate-amodiaquine (ASAQ', 'artesunate-amodiaquine (ASAQ']","['adults cure rates', 'adverse effects', 'Parasitemia and gametocytes', 'Fever clearance', 'D28 cure rates defined as absence of parasitemia', 'Hemoglobin']","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0331308', 'cui_str': 'Sagebrush'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0686899', 'cui_str': 'Sweet Annie'}, {'cui': 'C0331308', 'cui_str': 'Sagebrush'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0686869', 'cui_str': 'Gametocyte'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",957.0,0.338683,"Only 5.0% of Artemisia-treated patients reported adverse effects, vs. 42.8% for ASAQ.
","[{'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Munyangi', 'Affiliation': 'Faculté de Médecine Université de Kolwezi-Lualaba, Congo DRC.'}, {'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Cornet-Vernet', 'Affiliation': ""Vice Présidente de La Maison de l'Artemisia(association Loi 1901), 20 rue Pierre Demours, 75017Paris, France. Electronic address: lcv@maison-artemisia.org.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Idumbo', 'Affiliation': 'Centre de Santé de Lubile, Maniema, Congo DRC.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Mathematics, Worcester Polytechnic Institute, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Lutgen', 'Affiliation': 'Association IFVB-BELHERB, Luxembourg.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Perronne', 'Affiliation': 'Faculté de Médecine de Paris IDF Ouest, France.'}, {'ForeName': 'Nadège', 'Initials': 'N', 'LastName': 'Ngombe', 'Affiliation': 'Faculté de Pharmacie, Université de Kinshasa, Congo DRC.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Bianga', 'Affiliation': 'Programme National Lutte Contre le Paludisme, Maniema, Congo DRC.'}, {'ForeName': 'Bavon', 'Initials': 'B', 'LastName': 'Mupenda', 'Affiliation': 'Ecole de Santé Publique Université de Kinshasa, Congo DRC.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lalukala', 'Affiliation': 'Ministère Provincial de Santé Publique Maniema, Congo DRC.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Mergeai', 'Affiliation': 'Université de Liège, Belgium.'}, {'ForeName': 'Dieudonné', 'Initials': 'D', 'LastName': 'Mumba', 'Affiliation': 'Faculté de Médecine Université de Kinshasa, Congo DRC.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Towler', 'Affiliation': 'Department of Biology and Biotechnology, Worcester Polytechnic Institute, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Weathers', 'Affiliation': 'Department of Biology and Biotechnology, Worcester Polytechnic Institute, USA.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2018.12.002']
312,31988481,Effectiveness and cost-effectiveness of The Daily Mile on childhood weight outcomes and wellbeing: a cluster randomised controlled trial.,"BACKGROUND


The Daily Mile is designed to increase physical activity levels with children running or walking around school grounds for 15-min daily. It has been adopted by schools worldwide and endorsed as a solution to tackle obesity, despite no robust evidence of its benefits. We conducted a cluster randomised controlled trial to determine its clinical and cost-effectiveness.
METHODS


Forty schools were randomly assigned (1:1) to either the Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented. The primary outcome was BMI z-score (BMIz) at 12 months follow-up from baseline, with planned subgroup analysis to examine differential effects. Primary economic analysis outcome was incremental cost per Quality-Adjusted-Life-Year (QALY) gained.
RESULTS


Using a constrained randomisation approach, balanced on school size, baseline BMIz and proportion of pupils eligible for free school meals, 20 schools were allocated to intervention (n = 1,153 participants) and 20 to control (n = 1,127); 3 schools withdrew (2 intervention, 1 control). At 12 months, BMIz data were available for 18 intervention schools (n = 850) and 19 control schools (n = 820 participants). Using intention-to-treat analysis the adjusted mean difference (MD) in BMIz (intervention - control) was -0.036 (95% CI: -0.085 to 0.013, p = 0.146). Pre-specified subgroup analysis showed a significant interaction with sex (p = 0.001) suggesting a moderate size benefit of The Daily Mile in girls (MD -0.097, 95% CI -0.156 to -0.037). This was consistent with the exploratory economic results that showed The Daily Mile to be highly cost-effective in girls (£2,492 per QALY), but not in boys, and overall to have a 76% chance of cost-effectiveness for the whole sample, at the commonly applied UK threshold of £20,000 per QALY.
CONCLUSIONS


Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.",2020,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","['pupils eligible for free school meals, 20 schools', 'Forty schools']","['Daily Mile', 'Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented']","['Effectiveness and cost-effectiveness', 'physical activity levels', 'childhood weight outcomes and wellbeing', 'BMI z-score (BMIz', 'BMIz', 'incremental cost per Quality-Adjusted-Life-Year (QALY) gained']","[{'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",40.0,0.246083,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Breheny', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Passmore', 'Affiliation': 'Services for Education, Birmingham, B7 4AX, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. p.adab@bham.ac.uk.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Lancashire', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. e.frew@bham.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-019-0511-0']
313,31282394,Effect of spinal decompression therapy and core stabilization exercises in management of lumbar disc prolapse: A single blind randomized controlled trial.,"BACKGROUND


Spinal decompression therapy (SDT) has recently been used as a conservative treatment for lumbar disc prolapse (LDP). The effectiveness of SDT when compared with other conservative techniques with a well-designed randomized controlled trials is lacking.
OBJECTIVE


To find the efficacy of SDT and core stabilization exercises (CSE) on pain and functional disability in individuals with chronic LDP, and to compare with CSE alone.
METHODS


This single blind randomized controlled trial included thirty-one participants with a mean age of 38.68 ± 8.79 having chronic LDP with or without radiating symptoms were included in the study. The study group received SDT with CSE and control group received CSE alone along with interferential therapy for both groups. Pain and disability were estimated by Numerical Rating Scale (NRS) and Modified Oswestry Questionnaire (mOQ).
RESULTS


The results demonstrated significant within-group improvements in all outcomes in both groups, the mean differences between pre to post intervention in SDT with CSE group were (NRS: 4.75, t= 12.81, p⩽ 0.001) and (mOQ: 45.13, t= 29.34, p⩽ 0.001), while in CSE group (NRS: 2.60, t= 13.67, p⩽ 0.001) and (mOQ: 27.67, t= 24.52, p⩽ 0.001).
CONCLUSIONS


A combination of SDT with CSE has proven to be more significant when compared with CSE alone to reduce pain and disability in subjects with chronic LDP.",2020,"The results demonstrated significant within-group improvements in all outcomes in both groups, the mean differences between pre to post intervention in SDT with CSE group were (NRS: 4.75, t= 12.81, p⩽ 0.001) and (mOQ: 45.13, t= 29.34, p⩽ 0.001), while in CSE group (NRS: 2.60, t= 13.67, p⩽ 0.001) and (mOQ: 27.67, t= 24.52, p⩽ 0.001).
","['individuals with chronic LDP, and to compare with CSE alone', 'subjects with chronic LDP', 'lumbar disc prolapse', 'lumbar disc prolapse (LDP', 'thirty-one participants with a mean age of 38.68 ± 8.79 having chronic LDP with or without radiating symptoms were included in the study']","['CSE', 'CSE alone', 'Spinal decompression therapy (SDT', 'SDT', 'spinal decompression therapy and core stabilization exercises', 'SDT with CSE', 'SDT and core stabilization exercises (CSE']","['Pain and disability', 'pain and functional disability', 'pain and disability', 'Numerical Rating Scale (NRS) and Modified Oswestry Questionnaire (mOQ']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0408670', 'cui_str': 'Decompression of spinal cord'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",31.0,0.109177,"The results demonstrated significant within-group improvements in all outcomes in both groups, the mean differences between pre to post intervention in SDT with CSE group were (NRS: 4.75, t= 12.81, p⩽ 0.001) and (mOQ: 45.13, t= 29.34, p⩽ 0.001), while in CSE group (NRS: 2.60, t= 13.67, p⩽ 0.001) and (mOQ: 27.67, t= 24.52, p⩽ 0.001).
","[{'ForeName': 'Riziq Allah Mustafa', 'Initials': 'RAM', 'LastName': 'Gaowgzeh', 'Affiliation': ''}, {'ForeName': 'Mohamed Faisal', 'Initials': 'MF', 'LastName': 'Chevidikunnan', 'Affiliation': ''}, {'ForeName': 'Ejlal Abdullah', 'Initials': 'EA', 'LastName': 'BinMulayh', 'Affiliation': ''}, {'ForeName': 'Fayaz', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-171099']
314,31282395,Are oropharyngeal exercises effective in Obstructive Sleep Apnea Syndrome?,"OBJECTIVE


This study has been conducted to examine the effects of posture, cervical region and oropharyngeal exercises in patients with Obstructive Sleep Apnea Syndrome (OSAS).
METHOD


Thirty patients with OSAS have been randomly divided into two groups. The first group received supervised exercise program including oropharyngeal, posture and cervical region exercises for 12 weeks. The patients in the control group have been informed about the posture but the exercise was not recommended. Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI), Short Form 36 (SF-36), International Physical Activity Questionnaire-Short Form (IPAQ-SF) and 6 Minute Walk Test (6MWT) have been used in the evaluation of individuals participating in the study. Evaluations have been made at the beginning of the treatment and at the end of the 12-week exercise program.
RESULTS


Statistically significant improvements have been observed in the exercise group in PSQI total value, ESS score, SF-36 General Health Subscale and 6MWT (p< 0.05). Statistical significance could not be reached for other parameters.
CONCLUSIONS


Sleep quality, general health, and functional capacity have been found to improve in OSAS patients with oropharyngeal exercises.",2020,"RESULTS


Statistically significant improvements have been observed in the exercise group in PSQI total value, ESS score, SF-36 General Health Subscale and 6MWT (p< 0.05).","['patients with Obstructive Sleep Apnea Syndrome (OSAS', 'Obstructive Sleep Apnea Syndrome', 'OSAS patients with oropharyngeal exercises', 'Thirty patients with OSAS']","['supervised exercise program including oropharyngeal, posture and cervical region exercises', 'posture, cervical region and oropharyngeal exercises']","['Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI), Short Form 36 (SF-36), International Physical Activity Questionnaire-Short Form (IPAQ-SF) and 6 Minute Walk Test (6MWT', 'PSQI total value, ESS score, SF-36 General Health Subscale and 6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",30.0,0.012395,"RESULTS


Statistically significant improvements have been observed in the exercise group in PSQI total value, ESS score, SF-36 General Health Subscale and 6MWT (p< 0.05).","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Atilgan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Medipol University, Turkey.'}, {'ForeName': 'Erdoğan', 'Initials': 'E', 'LastName': 'Kunter', 'Affiliation': 'Department of Chest Diseases, Faculty of Medicine, Istanbul Medipol University, Turkey.'}, {'ForeName': 'Z Candan', 'Initials': 'ZC', 'LastName': 'Algun', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Medipol University, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-171101']
315,31594200,Comparison of two different electrotherapy methods in low back pain treatment.,"OBJECTIVE


To investigate the efficacy of High Intensity Laser Therapy (HILT) and Transcutaneous Electrical Nerve Stimulation (TENS) in low back pain (LBP).
METHODS


Forty patients aged between 18 to 60 were included in this study. The patients were randomized into two groups as TENS (Group I) and HILT (Group II). The severity of pain was measured by Visual Analog Scale (VAS), and the range of motion (ROM) of the joint was measured by goniometer. The Oswestry Disability Questionnaire (ODQ) was used to assess the effect of LBP on daily living activities, and the Beck Depression Inventory (BDI) was used to assess depression. All patients were taken into physical therapy program for 5 days a week for a total of 20 sessions. Patients in Group I received ultrasound, hot pack and HILT, while the patients in Group II received ultrasound, hot pack and TENS.
RESULTS


In the comparison of post-treatment improvements, among all parameters only VAS score had a significant difference in favor of Group I.
CONCLUSIONS


The study demonstrated that HILT is more effective than TENS in terms of pain reduction and that HILT can be used as an alternative to TENS.",2020,"In the comparison of post-treatment improvements, among all parameters only VAS score had a significant difference in favor of Group I.
","['Forty patients aged between 18 to 60 were included in this study', 'low back pain (LBP', 'low back pain treatment']","['TENS', 'ultrasound, hot pack and TENS', 'HILT', 'High Intensity Laser Therapy (HILT) and Transcutaneous Electrical Nerve Stimulation (TENS', 'ultrasound, hot pack and HILT', 'LBP']","['Visual Analog Scale (VAS), and the range of motion (ROM) of the joint', 'Oswestry Disability Questionnaire (ODQ', 'daily living activities, and the Beck Depression Inventory (BDI', 'severity of pain', 'pain reduction', 'VAS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0444519', 'cui_str': 'Hot sensation quality (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",40.0,0.0277491,"In the comparison of post-treatment improvements, among all parameters only VAS score had a significant difference in favor of Group I.
","[{'ForeName': 'Dilanur Kutlu', 'Initials': 'DK', 'LastName': 'Ozkaraoglu', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Istanbul Medipol University Faculty of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Devrim', 'Initials': 'D', 'LastName': 'Tarakci', 'Affiliation': 'Department of Ergotherapy, Istanbul Medipol University Faculty of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Zeliha Candan', 'Initials': 'ZC', 'LastName': 'Algun', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Istanbul Medipol University Faculty of Health Sciences, Istanbul, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181199']
316,32222367,"A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis.","PURPOSE


To evaluate the efficacy and safety of a topical ophthalmic suspension combination of povidone-iodine 0.6% (PVP-I) and dexamethasone 0.1% (DEX) for infectious and inflammatory components of bacterial conjunctivitis.
DESIGN


Randomized, double-masked, multicenter, phase 3 clinical trial.
METHODS


Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis were randomized 3:1:3 to either PVP-I/DEX, PVP-I alone, or placebo. The primary endpoint was clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication, both at the day 5 visit. Adverse events (AEs) were documented at all visits.
RESULTS


Overall, 753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [n = 324]; PVP-I [n = 108]; placebo [n = 321]); mean and standard deviation (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%). In all treatment groups, mean treatment compliance was >98%. The modified ITT population for the efficacy analysis comprised 526 subjects. In the study eye at the day 5 visit, clinical resolution was achieved by 50.5% (111/220) subjects in the PVP-I/DEX group vs 42.8% (95/222) in the placebo group (P = .127), and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively (P = .500). Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108), and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity).
CONCLUSION


In this study, PVP-I/DEX did not demonstrate additional benefit in clinical efficacy compared with placebo in subjects with bacterial conjunctivitis.",2020,"Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108) and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively","['Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis', 'Acute Bacterial Conjunctivitis', 'subjects with bacterial conjunctivitis', '526 subjects', '753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [N = 324]; PVP-I [N = 108]; placebo [N = 321]); mean (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1']","['placebo', 'Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension', 'PVP-I/DEX, PVP-I 0.6% alone, or placebo', 'DEX', 'topical ophthalmic suspension combination of povidone-iodine (PVP-I; 0.6%) and dexamethasone (DEX']","['bacterial eradication', 'efficacy and safety', 'Adverse events (AEs', 'clinical resolution', 'mean treatment compliance', 'clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0009768', 'cui_str': 'Conjunctivitis, Mucopurulent'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517833', 'cui_str': '61.2 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0976129', 'cui_str': 'dexamethasone 0.1 % Ophthalmic Suspension'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0991532', 'cui_str': 'Ophthalmic Suspension'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319828', 'cui_str': 'Therapeutic Compliance'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",753.0,0.425662,"Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108) and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively","[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Ta', 'Affiliation': 'Stanford University School of Medicine, Byers Eye Institute at Stanford, Palo Alto, California, USA. Electronic address: cta@stanford.edu.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Raizman', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Gross', 'Affiliation': 'Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Sunir', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Pinnacle Research Institute, Fort Lauderdale, Florida, USA.'}, {'ForeName': 'Sushanta', 'Initials': 'S', 'LastName': 'Mallick', 'Affiliation': 'Shire, A Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Shire, A Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Segal', 'Affiliation': 'Private Practice, Delray Beach, Florida, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.03.018']
317,30866027,Effect of Treatment of Mild Gestational Diabetes on Long-Term Maternal Outcomes.,"OBJECTIVE


The main purpose of this article is to evaluate whether identification and treatment of women with mild gestational diabetes mellitus (GDM) during pregnancy affects subsequent maternal body mass index (BMI), anthropometry, metabolic syndrome, and risk of diabetes.
STUDY DESIGN


This is a follow-up study of women who participated in a randomized controlled treatment trial for mild GDM. Women were enrolled between 5 and 10 years after their index pregnancy. Participants underwent blood pressure, height, weight, and anthropometric measurements by trained nursing personnel using a standardized approach. A nurse-assisted questionnaire regarding screening and treatment of diabetes or hypercholesterolemia, diet, and physical activity was completed. Laboratory evaluation included fasting serum glucose, fasting insulin, oral glucose tolerance test, and a lipid panel. Subsequent diabetes, metabolic syndrome, obesity, and adiposity in those diagnosed with mild GDM and randomized to nutritional counseling and medical therapy (treated) were compared with those who underwent routine pregnancy management (untreated). Multivariable analyses were performed adjusting for race/ethnicity and years between randomization and follow-up visit.
RESULTS


Four-hundred fifty-seven women with mild GDM during the index pregnancy were included in this analysis (243 treated; 214 untreated) and evaluated at a median 7 years after their index pregnancy. Baseline and follow-up characteristics were similar between treatment groups. Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
CONCLUSION


Identification and treatment of women with mild GDM during pregnancy had no discernible impact on subsequent diabetes, metabolic syndrome, or obesity 7 years after delivery.",2020,"Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
","['women with mild gestational diabetes mellitus (GDM', 'Four-hundred fifty-seven women with mild GDM during the index pregnancy were included in this analysis (243 treated; 214 untreated) and evaluated at a median 7 years after their index pregnancy', 'Women were enrolled between 5 and 10 years after their index pregnancy', 'women who participated in a randomized controlled treatment trial for mild GDM']",['nutritional counseling and medical therapy (treated'],"['metabolic syndrome', 'homeostasis model assessment for insulin resistance', 'BMI', 'Frequency of diabetes', 'Subsequent diabetes, metabolic syndrome, obesity, and adiposity', 'maternal body mass index (BMI), anthropometry, metabolic syndrome, and risk of diabetes', 'fasting serum glucose, fasting insulin, oral glucose tolerance test, and a lipid panel']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel (procedure)'}]",457.0,0.0436331,"Frequency of diabetes (9.2 vs. 8.5%,  p  =0.80), metabolic syndrome (32.2 vs. 34.3%,  p  =0.63), as well as adjusted mean values of homeostasis model assessment for insulin resistance (2.5 vs. 2.3,  p  =0.11) and BMI (29.4 vs. 29.1 kg/m 2 ,  p  =0.67) were also not different.
","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': 'George Washington University Biostatistics Center, Washington, District of Columbia.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Landon', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Biggio', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'Department of Obstetrics and Gynecology, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.""}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'Van Dorsten', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0039-1681058']
318,32218251,Engagement with a Web-Based Health Promotion Intervention among Vocational School Students: A Secondary User and Usage Analysis.,"Engagement with web-based interventions is both generally low and typically declining. Visits and revisits remain a challenge. Based on log data of a web-based cluster randomized controlled trial conducted in vocational schools, the present secondary analysis aimed to identify influencing factors on initially logging in to a health promotion platform among young adults and to examine the engagement over the course of an eight-week intervention. Data of 336 students (62.2% female, age span 18-25) from two intervention arms (web-based intervention and web-based intervention with an additional initial face-to-face contact) was included. Binary logistic regression and log-data visualization were performed. An additional initial face-to-face contact (odds ratio (OR) = 2.971,  p  = 0.005), female sex (OR = 2.237,  p  = 0.046) and the health-related skill ""dealing with health information"" (OR = 2.179,  p  = 0.030) significantly increased the likelihood of initially logging in. Other variables showed no influence. 16.6% of all potential users logged in at least once, of which 57.4% revisited the platform. Most logins were tracked at the beginning of the intervention and repeated engagement was low. To increase the engagement with web-based interventions, health-related skills should be fostered. In addition, a strategy could be to interlink comparable interventions in vocational schools more regularly with everyday teaching through multi-component interventions.",2020,"An additional initial face-to-face contact (odds ratio (OR) = 2.971,  p  = 0.005), female sex (OR = 2.237,  p  = 0.046) and the health-related skill ""dealing with health information"" (OR = 2.179,  p  = 0.030) significantly increased the likelihood of initially logging in.","['young adults', 'Vocational School Students', '336 students (62.2% female, age span 18-25) from two intervention arms (web-based intervention and web-based intervention with an additional initial face-to-face contact) was included', 'vocational schools']",['Web-Based Health Promotion Intervention'],"['health-related skill ""dealing with health information']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",336.0,0.0433428,"An additional initial face-to-face contact (odds ratio (OR) = 2.971,  p  = 0.005), female sex (OR = 2.237,  p  = 0.046) and the health-related skill ""dealing with health information"" (OR = 2.179,  p  = 0.030) significantly increased the likelihood of initially logging in.","[{'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Stassen', 'Affiliation': 'Working Group Physical Activity-Related Prevention Research, Institute of Movement Therapy and Movement-oriented Prevention and Rehabilitation, German Sport University Cologne, D-50933 Cologne, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Grieben', 'Affiliation': 'Department 1: Movement-oriented Prevention and Rehabilitation Sciences, Institute of Movement Therapy and Movement-oriented Prevention and Rehabilitation, German Sport University Cologne, D-50933, Cologne, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Froböse', 'Affiliation': 'Department 1: Movement-oriented Prevention and Rehabilitation Sciences, Institute of Movement Therapy and Movement-oriented Prevention and Rehabilitation, German Sport University Cologne, D-50933, Cologne, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaller', 'Affiliation': 'Working Group Physical Activity-Related Prevention Research, Institute of Movement Therapy and Movement-oriented Prevention and Rehabilitation, German Sport University Cologne, D-50933 Cologne, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17072180']
319,30895579,Utilizing Video versus Direct Laryngoscopy to Intubate Simulated Newborns while Contained within the Incubator: A Randomized Crossover Study.,"OBJECTIVE


The use of video laryngoscopy for intubating neonates in ergonomically challenging settings has not been studied well. We aimed to assess the usefulness of video laryngoscopy for experienced neonatologists to intubate neonatal manikins in incubators via side hand ports or head window.
STUDY DESIGN


In this randomized crossover trial at three neonatal intensive care units in Japan, 27 neonatologists were randomized into two groups, namely, those intubating neonatal simulators using video laryngoscopy and then using direct laryngoscopy, or vice versa. The intubations were performed via hand ports or head window without opening top and side walls in incubators in two manikin positions (rotated 90° or unrotated). Glottis visualization (0-100%), success rate, intubation time, and ease of laryngoscopy (from 1 [very difficult] to 10 [very easy]) were compared between video laryngoscopy and direct laryngoscopy. Generalized linear models were used for the analyses.
RESULTS


This study assessed 108 intubations performed by 27 neonatologists. The use of video laryngoscopy improved the glottis visualization by 14% (95% confidence interval, 7.4-20%;  p  < 0.01) and easiness scores of laryngoscopy by 0.8 (0.2-1.4;  p  < 0.01), but did not reduce the intubation time.
CONCLUSION


Video laryngoscopy is useful for experienced neonatologists for intubating neonatal manikins in incubators without opening the top or side walls.",2020,"The use of video laryngoscopy improved the glottis visualization by 14% (95% confidence interval, 7.4-20%;  p  < 0.01) and easiness scores of laryngoscopy by 0.8 (0.2-1.4;  p  < 0.01), but did not reduce the intubation time.
","['108 intubations performed by 27 neonatologists', 'three neonatal intensive care units in Japan, 27 neonatologists']","['intubating neonatal simulators using video laryngoscopy and then using direct laryngoscopy, or vice versa', 'video laryngoscopy', 'intubations were performed via hand ports or head window without opening top and side walls in incubators in two manikin positions (rotated 90° or unrotated', 'Utilizing Video versus Direct Laryngoscopy', 'Video laryngoscopy']","['Glottis visualization', 'intubation time', 'success rate, intubation time, and ease of laryngoscopy', 'easiness scores of laryngoscopy', 'glottis visualization']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0334898', 'cui_str': 'Neonatologists'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0231458', 'cui_str': 'Rotated (qualifier value)'}]","[{'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",108.0,0.0560904,"The use of video laryngoscopy improved the glottis visualization by 14% (95% confidence interval, 7.4-20%;  p  < 0.01) and easiness scores of laryngoscopy by 0.8 (0.2-1.4;  p  < 0.01), but did not reduce the intubation time.
","[{'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Ozawa', 'Affiliation': 'Division of Neonatology, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Shigehiro', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Division of Neonatology, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Humiko', 'Initials': 'H', 'LastName': 'Miyahara', 'Affiliation': 'Division of Neonatology, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Hosoi', 'Affiliation': 'Department of Pediatrics, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mazumi', 'Initials': 'M', 'LastName': 'Miura', 'Affiliation': 'Division of Pediatrics and Perinatology, Tottori University Faculty of Medicine, Yonago, Japan.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Morisaki', 'Affiliation': 'Department of Social Medicine, Research Institute, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Division of Neonatology, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Isayama', 'Affiliation': 'Division of Neonatology, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}]",American journal of perinatology,['10.1055/s-0039-1683957']
320,31905348,Study of the beneficial role of exhaled nitric oxide in combination with GINA guidelines for titration of inhaled corticosteroids in children with asthma.,"BACKGROUND


The use of FE NO  in association with current guidelines in the treatment of asthma has not been studied thoroughly. This study aimed to evaluate the beneficial role of FE NO  in combination with GINA (Global Initiative for Asthma) guidelines for titration of inhaled corticosteroids (ICS) in asthmatic children.
METHODS


It was a prospective and descriptive study. Uncontrolled asthmatic children were randomized to two groups: group 1 (followed GINA guidelines) or group 2 (followed GINA guidelines + FE NO  modification for ICS titration). The two groups were followed-up for 12 months.
RESULTS


The mean age of the patients in the study was 10 ± 4 years for group 1 (n = 116) and 11 ± 5 years for group 2 (n = 108). There were 87.9% patients in group 1 and 82.4% in group 2 that had a familial allergic history. There were 58.6% of moderate asthma and 41.4% of severe asthma in group 1, versus 56.4% and 43.6% in group 2, respectively. The percentage of moderate and severe asthma was also significantly modified after 6th and 12th month versus at inclusion (43.1% and 35.3% versus 58.6%, P < 0.01 and P < 0.005; 23.2% and 12.9% versus 41.4%, P < 0.005 and P < 0.001, respectively). The total daily dose of ICS in group 2 at 12th months was significantly lower than that in group 1 (3515 ± 1175 versus 4785 ± 1235 mcg; P < 0.005). The daily cost of ICS treatment in group 2 was also lower than that of group 1 (18 ± 4 versus 27 ± 3 USD; P < 0.05).
CONCLUSION


The use of FE NO  in combination with GINA guidelines for ICS titration is useful in reducing the daily ICS dose and treatment cost.",2020,There was 87.9% patients in group 1 and 82.4% in group 2 had a familial allergic history.,"['asthmatic children', 'The mean age of study patients was 10±4 years for group 1 (n=116) and 11±5 years for group 2 (n=108', 'Uncontrolled asthmatic children', 'children with asthma']","['ICS', 'FENO in combination with GINA (Global Initiative', 'FENO', 'group 1 (followed GINA guidelines) or group 2 (followed GINA guidelines + FENO modification for ICS titration', 'inhaled corticosteroids (ICS']","['familial allergic history', 'daily cost of ICS treatment', 'severe asthma', 'percentage of moderate and severe asthma']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",,0.0282384,There was 87.9% patients in group 1 and 82.4% in group 2 had a familial allergic history.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dinh-Thi-Dieu', 'Affiliation': 'Hai Duong Medical Technical University. Hai Duong, Vietnam.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tang-Thi-Thao', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': ''}]",Journal of breath research,['10.1088/1752-7163/ab6809']
321,32220636,Impact of rapid microbial identification on clinical outcomes in bloodstream infection: the RAPIDO randomized trial.,"OBJECTIVES


Bloodstream infection has a high mortality rate. It is not clear whether laboratory-based rapid identification of the organisms involved would improve outcome.
METHODS


The RAPIDO trial was an open parallel-group multicentre randomized controlled trial. We tested all positive blood cultures from hospitalized adults by conventional methods of microbial identification and those from patients randomized (1:1) to rapid diagnosis in addition to matrix-assisted desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) performed directly on positive blood cultures. The only primary outcome was 28-day mortality. Clinical advice on patient management was provided to members of both groups by infection specialists.
RESULTS


First positive blood culture samples from 8628 patients were randomized, 4312 into rapid diagnosis and 4136 into conventional diagnosis. After prespecified postrandomization exclusions, 2740 in the rapid diagnosis arm and 2810 in the conventional arm were included in the mortality analysis. There was no significant difference in 28-day survival (81.5% 2233/2740 rapid vs. 82.3% 2313/2810 conventional; hazard ratio 1.05, 95% confidence interval 0.93-1.19, p 0.42). Microbial identification was quicker in the rapid diagnosis group (median (interquartile range) 38.5 (26.7-50.3) hours after blood sampling vs. 50.3 (47.1-72.9) hours after blood sampling, p < 0.01), but times to effective antimicrobial therapy were no shorter (respectively median (interquartile range) 24 (2-78) hours vs. 13 (2-69) hours). There were no significant differences in 7-day mortality or total antibiotic consumption; times to resolution of fever, discharge from hospital or de-escalation of broad-spectrum therapy or 28-day Clostridioides difficile incidence.
CONCLUSIONS


Rapid identification of bloodstream pathogens by MALDI-TOF MS in this trial did not reduce patient mortality despite delivering laboratory data to clinicians sooner.",2020,"Microbial identification was quicker in the rapid diagnosis group (median 38·5 vs 50·3 hours after blood sampling, IQR 26·7-50·3 vs 47·1-72·9, p<0·01) but times to effective antimicrobial therapy were no shorter (median 24 hours (IQR 2-78) vs 13 hours (IQR 2-69)).","['bloodstream infection', '8,628 patients were randomised, 4,312 into rapid diagnosis, 4,136 into conventional']",['rapid microbial identification'],"['28-day survival', '7-day mortality or total antibiotic consumption; times to resolution of fever, discharge from hospital or de-escalation of broad spectrum therapy; or 28-day Clostridioides difficile incidence', 'Microbial identification', '28-day mortality']","[{'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]",8628.0,0.527018,"Microbial identification was quicker in the rapid diagnosis group (median 38·5 vs 50·3 hours after blood sampling, IQR 26·7-50·3 vs 47·1-72·9, p<0·01) but times to effective antimicrobial therapy were no shorter (median 24 hours (IQR 2-78) vs 13 hours (IQR 2-69)).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'MacGowan', 'Affiliation': 'Department of Pathology Sciences, North Bristol NHS Trust, Southmead Hospital, Bristol, UK. Electronic address: alasdair.macgowan@nbt.nhs.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Grier', 'Affiliation': 'Department of Pathology Sciences, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stoddart', 'Affiliation': 'Department of Pathology Sciences, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Reynolds', 'Affiliation': 'Population Health Sciences, Bristol Medical School, Bristol, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Bristol Royal Infirmary, Clinical Support Unit, Bristol, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Pike', 'Affiliation': 'Bristol Royal Infirmary, Clinical Support Unit, Bristol, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Smartt', 'Affiliation': 'Bristol Royal Infirmary, Clinical Support Unit, Bristol, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wilcox', 'Affiliation': 'Department of Microbiology, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Wilson', 'Affiliation': 'Department of Clinical Microbiology, UCLH NHS Foundation Trust, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kelsey', 'Affiliation': 'Department of Medical Microbiology, Whittington Hospital, Whittington NHS Trust, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Steer', 'Affiliation': 'Department of Microbiology, Derriford Hospital, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'F K', 'Initials': 'FK', 'LastName': 'Gould', 'Affiliation': 'Department of Medical Microbiology, Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, England, UK.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Perry', 'Affiliation': 'Department of Medical Microbiology, Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, England, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Howe', 'Affiliation': 'Department of Microbiology, Public Health Wales, Cardiff University Hospital of Wales, Cardiff, Wales, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wootton', 'Affiliation': 'Department of Microbiology, Public Health Wales, Cardiff University Hospital of Wales, Cardiff, Wales, UK.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.01.030']
322,32217211,Quantifying lower limb inter-joint coordination and coordination variability after four-month wearing arch support foot orthoses in children with flexible flat feet.,"INTRODUCTION


Flat feet in children negatively affect lower limb alignment and cause adverse health-related problems. The long-term application of foot orthoses (FOs) may have the potential to improve lower limb coordination and its variability.
AIM


To evaluate the effects of long-term use of arch support FOs on inter-joint coordination and coordination variability in children with flexible flat feet.
METHODS


Thirty boys with flexible flat feet were randomly assigned to the experimental (EG) and control groups. The EG used medial arch support FOs during daily activities over a four-month period while the control group received a flat 2-mm-thick insole for the same time period. Lower-limb coordination and variability during the 3 sub-stance phases were quantified using a vector coding technique.
RESULTS


Frontal plane ankle-hip coordination in EG during mid-stance changed to an anti-phase pattern (156.9 ° ) in the post-test compared to an in-phase (221.1 ° ) in the pre-test of EG and post-test of CG (222.7). Frontal plane knee-hip coordination in EG during loading response (LR) changed to an anti-phase pattern (116 ° ) in the post-test compared to an in-phase (35.5 ° ) in the pre-test of EG and post-test of CG (35.3). Ankle inversion/eversion-knee internal/external rotation joint coupling angle in EG changed to an in-phase pattern (59 ° ) in the post-test compared to a proximal phase (89 ° ) in the pre-test. Coupling angle variability increased in the post-test of EG for sagittal plane ankle-hip during push-off, transverse plane ankle-hip during LR and mid-stance, and transverse plane knee-hip during LR and mid-stance compared to pre-test of EG and post-test of CG.
CONCLUSION


The long-term use of arch support FOs proved to be effective to alter lower limb coordination and coordination variability during walking in children with flexible flat feet. This new insight into coordinative function may be useful for improving corrective exercise strategies planned for children with flat feet.",2020,The long-term use of arch support FOs proved to be effective to alter lower limb coordination and coordination variability during walking in children with flexible flat feet.,"['Thirty boys with flexible flat feet', 'children with flexible flat feet', 'children with flat feet']","['Ankle inversion/eversion-knee internal/external rotation joint coupling angle', 'foot orthoses (FOs', 'CG']","['Coupling angle variability', 'limb coordination and coordination variability']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0016202', 'cui_str': 'Splayfoot'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0021945', 'cui_str': 'Inversion (morphologic abnormality)'}, {'cui': 'C0015211', 'cui_str': 'Eversion (morphologic abnormality)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0442222', 'cui_str': 'Internal/external rotation (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1283250', 'cui_str': 'Foot Orthotic Devices'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}]",30.0,0.0198977,The long-term use of arch support FOs proved to be effective to alter lower limb coordination and coordination variability during walking in children with flexible flat feet.,"[{'ForeName': 'AmirAli', 'Initials': 'A', 'LastName': 'Jafarnezhadgero', 'Affiliation': 'University of Mohaghegh Ardabili, Faculty of Educational Sciences and Psychology, Department of Physical Education and Sport Sciences, Ardabil, Iran.'}, {'ForeName': 'Seyed Hamed', 'Initials': 'SH', 'LastName': 'Mousavi', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine, Groningen, the Netherlands; University of Tehran, Faculty of Physical Education and Sport Sciences, Department of Health and Sport Medicine, Tehran, Iran. Electronic address: s.h.mousavi@umcg.nl.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Madadi-Shad', 'Affiliation': 'Bu-Ali Sina University, Department of Sport Biomechanics, Hamedan, Iran.'}, {'ForeName': 'Juha M', 'Initials': 'JM', 'LastName': 'Hijmans', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine, Groningen, the Netherlands.'}]",Human movement science,['10.1016/j.humov.2020.102593']
323,32132009,"Impact of a Telephonic Intervention to Improve Diabetes Control on Health Care Utilization and Cost for Adults in South Bronx, New York.","OBJECTIVE


Self-management education and support are essential for improved diabetes control. A 1-year randomized telephonic diabetes self-management intervention (Bronx A1C) among a predominantly Latino and African American population in New York City was found effective in improving blood glucose control. To further those findings, this current study assessed the intervention's impact in reducing health care utilization and costs over 4 years.
RESEARCH DESIGN AND METHODS


We measured inpatient ( n  = 816) health care utilization for Bronx A1C participants using an administrative data set containing all hospital discharges for New York State from 2006 to 2014. Multilevel mixed modeling was used to assess changes in health care utilization and costs between the telephonic diabetes intervention (Tele/Pr) arm and print-only (PrO) control arm.
RESULTS


During follow-up, excess relative reductions in all-cause hospitalizations for the Tele/Pr arm compared with PrO arm were statistically significant for odds of hospital use (odds ratio [OR] 0.89; 95% CI 0.82, 0.97;  P  < 0.01), number of hospital stays (rate ratio [RR] 0.90; 95% CI 0.81, 0.99;  P  = 0.04), and hospital costs (RR 0.90; 95% CI 0.84, 0.98;  P  = 0.01). Reductions in hospital use and costs were even stronger for diabetes-related hospitalizations. These outcomes were not significantly related to changes observed in hemoglobin A 1c  during individuals' participation in the 1-year intervention.
CONCLUSIONS


These results indicate that the impact of the Bronx A1C intervention was not just on short-term improvements in glycemic control but also on long-term health care utilization. This finding is important because it suggests the benefits of the intervention were long-lasting with the potential to not only reduce hospitalizations but also to lower hospital-associated costs.",2020,"These outcomes were not significantly related to changes observed in hemoglobin A 1c  during individuals' participation in the 1-year intervention.
","['predominantly Latino and African American population in New York City', 'Adults in South Bronx, New York', 'inpatient ( n  = 816) health care utilization for Bronx A1C participants using an administrative data set containing all hospital discharges for New York State from 2006 to 2014']","['Bronx A1C intervention', 'Telephonic Intervention', 'telephonic diabetes intervention (Tele/Pr) arm and print-only control (PrO) arm', 'telephonic diabetes self-management intervention (Bronx A1C']","['Health Care Utilization and Cost', 'hospital use and costs', 'number of hospital stays', 'blood glucose control', 'glycemic control', 'health care utilization and costs', 'hospital costs']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}]","[{'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}]",,0.0255034,"These outcomes were not significantly related to changes observed in hemoglobin A 1c  during individuals' participation in the 1-year intervention.
","[{'ForeName': 'Bahman P', 'Initials': 'BP', 'LastName': 'Tabaei', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY btabaei@health.nyc.gov.'}, {'ForeName': 'Renata E', 'Initials': 'RE', 'LastName': 'Howland', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gonzalez', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Chamany', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Walker', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Clyde B', 'Initials': 'CB', 'LastName': 'Schechter', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Winfred Y', 'Initials': 'WY', 'LastName': 'Wu', 'Affiliation': 'New York City Department of Health and Mental Hygiene, New York, NY.'}]",Diabetes care,['10.2337/dc19-0954']
324,31812510,"Effects of Belapectin, an Inhibitor of Galectin-3, in Patients With Nonalcoholic Steatohepatitis With Cirrhosis and Portal Hypertension.","BACKGROUND & AIMS


Increased levels of galectin 3 have been associated with nonalcoholic steatohepatitis (NASH) and contribute to toxin-induced liver fibrosis in mice. GR-MD-02 (belapectin) is an inhibitor of galectin 3 that reduces liver fibrosis and portal hypertension in rats and was safe and well tolerated in phase 1 studies. We performed a phase 2b, randomized trial of the safety and efficacy of GR-MD-02 in patients with NASH, cirrhosis, and portal hypertension.
METHODS


Patients with NASH, cirrhosis, and portal hypertension (hepatic venous pressure gradient [HVPG] ≥ 6 mm Hg) from 36 centers were randomly assigned, in a double-blind manner, to groups that received biweekly infusions of belapectin 2 mg/kg (n = 54), 8 mg/kg (n = 54), or placebo (n = 54) for 52 weeks. The primary endpoint was change in HVPG (Δ HVPG) at the end of the 52-week period compared with baseline. Secondary endpoints included changes in liver histology and development of liver-related outcomes.
RESULTS


We found no significant difference in ΔHVPG between the 2 mg/kg belapectin group and placebo group (-0.28 mm HG vs 0.10 mm HG, P = 1.0) or between the 8 mg/kg belapectin and placebo group (-0.25 mm HG vs 0.10 mm HG, P = 1.0). Belapectin had no significant effect on fibrosis or nonalcoholic fatty liver disease activity score, and liver-related outcomes did not differ significantly among groups. In an analysis of a subgroup of patients without esophageal varices at baseline (n = 81), 2 mg/kg belapectin was associated with a reduction in HVPG at 52 weeks compared with baseline (P = .02) and reduced development of new varices (P = .03). Belapectin (2 mg/kg) was well tolerated and produced no safety signals.
CONCLUSIONS


In a phase 2b study of 162 patients with NASH, cirrhosis, and portal hypertension, 1 year of biweekly infusion of belapectin was safe but not associated with significant reduction in HVPG or fibrosis compared with placebo. However, in a subgroup analysis of patients without esophageal varices, 2 mg/kg belapectin did reduce HVPG and development of varices. ClinicalTrials.gov number: NCT02462967.",2020,"We found no significant difference in ΔHVPG between the 2 mg/kg belapectin group and placebo group (-0.28 mm HG vs 0.10 mm HG, P = 1.0) or between the 8 mg/kg belapectin and placebo group (-0.25 mm HG vs 0.10 mm HG, P = 1.0).","['Patients With Nonalcoholic Steatohepatitis With Cirrhosis and Portal Hypertension', '6 mm Hg) from 36 centers', 'Patients with NASH, cirrhosis, and portal hypertension (hepatic venous pressure gradient', '162 patients with NASH, cirrhosis, and portal hypertension', 'patients with NASH, cirrhosis, and portal hypertension']","['HVPG', 'placebo', 'belapectin', 'Belapectin', 'GR-MD-02 (belapectin', 'GR-MD-02']","['liver fibrosis and portal hypertension', 'HVPG or fibrosis', 'ΔHVPG', 'esophageal varices', 'HVPG and development of varices', 'HVPG', 'fibrosis or nonalcoholic fatty liver disease activity score, and liver-related outcomes', 'changes in liver histology and development of liver-related outcomes', 'change in HVPG (-28', 'reduced development of new varices', 'tolerated and produced no safety signals']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4049263', 'cui_str': 'Hepatic venous pressure gradient'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0020541', 'cui_str': 'Portal Hypertension'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0014867', 'cui_str': 'Esophageal Varices'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",162.0,0.533553,"We found no significant difference in ΔHVPG between the 2 mg/kg belapectin group and placebo group (-0.28 mm HG vs 0.10 mm HG, P = 1.0) or between the 8 mg/kg belapectin and placebo group (-0.25 mm HG vs 0.10 mm HG, P = 1.0).","[{'ForeName': 'Naga', 'Initials': 'N', 'LastName': 'Chalasani', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana. Electronic address: nchalasa@iu.edu.'}, {'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Garcia-Tsao', 'Affiliation': 'Yale University, New Haven, Colorado.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Vuppalanchi', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Texas Liver Institute, San Antonio, Texas.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Rinella', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Noureddin', 'Affiliation': 'Cedar Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Maxmillan', 'Initials': 'M', 'LastName': 'Pyko', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Shiffman', 'Affiliation': 'Liver Institute of Virginia, Richmond and Newport News, Virginia.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Allgood', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Shlevin', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'Rex', 'Initials': 'R', 'LastName': 'Horton', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'Eliezer', 'Initials': 'E', 'LastName': 'Zomer', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Irish', 'Affiliation': 'East Carolina University, Greenville, South Carolina.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Goodman', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Pinnacle Research Institute, San Antonio, Texas.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Traber', 'Affiliation': 'Galectin Therapeutics Alpharetta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2019.11.296']
325,30705390,Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.,"BACKGROUND


The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years.
METHODS


Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years.
RESULTS


Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice.
CONCLUSIONS


A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m 2  reduces healthcare costs and improves health more than advising weight loss.",2019,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","['Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity', 'patients with a BMI of at least 30\u2009kg/m 2  reduces healthcare costs and improves health more than advising weight loss', '1882 consecutively attending primary care patients who were obese and participants']","['physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice']","['disease incidence, quality of life, and healthcare costs', 'cumulative incidence of weight-related disease', 'weight loss', 'health service costs']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1882.0,0.159942,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Retat', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pimpin', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Abbygail', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christian-Brown', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Ashby Road, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. paul.aveyard@phc.ox.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0295-7']
326,30538282,Prefronto-cerebellar neuromodulation affects appetite in obesity.,"Human neuroimaging studies have consistently reported changes in cerebellar function and integrity in association with obesity. To date, however, the nature of this link has not been studied directly. Emerging evidence suggests a role for the cerebellum in higher cognitive functions through reciprocal connections with the prefrontal cortex. The purpose of this exploratory study was to examine appetite changes associated with noninvasive prefronto-cerebellar neuromodulation in obesity. Totally, 12 subjects with class I obesity (mean body mass index 32.9 kg/m 2 ) underwent a randomized, single-blinded, sham-controlled, crossover study, during which they received transcranial direct current stimulation ((tDCS); active/sham) aimed at simultaneously enhancing the activity of the prefrontal cortex and decreasing the activity of the cerebellum. Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated. We found that active tDCS caused an increase in hunger and desire to eat following food-cue exposure. In line with these data, subjects also tended to make more errors during the working memory task. No changes in basic motor performance occurred. This study represents the first demonstration that prefronto-cerebellar neuromodulation can influence appetite in individuals with obesity. While preliminary, our findings support a potential role for prefronto-cerebellar pathways in the behavioral manifestations of obesity.",2019,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"['individuals with obesity', '12 subjects with class']","['transcranial direct current stimulation ((tDCS); active/sham', 'active tDCS', 'prefronto-cerebellar neuromodulation', 'Prefronto-cerebellar neuromodulation']","['basic motor performance', 'appetite (state and food-cue-triggered) and performance', 'hunger and desire to eat']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",12.0,0.0223505,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marron', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain. emunozmarr@uoc.edu.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': 'Endocrinology Department, Clínica Sagrada Familia. Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Pilar García', 'Initials': 'PG', 'LastName': 'Lorda', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Soterix Medical, New York City, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, City College of New York (CCNY), New York, NY, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. malonso@bidmc.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0278-8']
327,30568260,Personalized nutrition: pretreatment glucose metabolism determines individual long-term weight loss responsiveness in individuals with obesity on low-carbohydrate versus low-fat diet.,"BACKGROUND/OBJECTIVES


The interaction between fasting plasma glucose (FPG) and fasting insulin (FI) concentrations and diets with different carbohydrate content were studied as prognostic markers of weight loss as recent studies up to 6 months of duration have suggested the importance of these biomarkers.
SUBJECTS/METHODS


This was a retrospective analysis of a clinical trial where participants with obesity were randomized to an ad libitum low-carbohydrate diet or a low-fat diet with low energy content (1200-1800 kcal/day [≈ 5.0-7.5 MJ/d]; ≤ 30% calories from fat) for 24 months. Participants were categorized (pretreatment) as normoglycemic (FPG < 5.6 mmol/L) or prediabetic (FPG ≥ 5.6-6.9 mmol/L) and further stratified by median FI. Linear mixed models were used to examine outcomes by FPG and FI values.
RESULTS


After 2 years, participants with prediabetes and high FI lost 7.2  kg (95% CI 2.1;12.2, P = 0.005) more with the low-fat than low-carbohydrate diet, whereas those with prediabetes and low FI tended to lose 6.2  kg (95% CI -0.9;13.3, P = 0.088) more on the low-carbohydrate diet than low-fat diet [mean difference: 13.3 kg (95% CI 4.6;22.0, P = 0.003)]. No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
CONCLUSIONS


Fasting plasma glucose and insulin are strong predictors of the weight loss response to diets with different macronutrient composition and might be a useful approach for personalized weight management.",2019,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","['Participants were categorized (pretreatment) as normoglycemic (FPG\u2009<\u20095.6\u2009mmol/L) or prediabetic (FPG\u2009≥\u20095.6-6.9\u2009mmol/L) and further stratified by median FI', 'individuals with obesity on low-carbohydrate versus low-fat diet', 'participants with obesity']",['ad libitum low-carbohydrate diet or a low-fat diet with low energy content'],['fasting plasma glucose (FPG) and fasting insulin (FI) concentrations'],"[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0200382,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16).
","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yishai', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'Lorien E', 'Initials': 'LE', 'LastName': 'Urban', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'R Drew', 'Initials': 'RD', 'LastName': 'Sayer', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0298-4']
328,32221587,"Comparison of interleukin-6, C-reactive protein, and low-density lipoprotein cholesterol as biomarkers of residual risk in contemporary practice: secondary analyses from the Cardiovascular Inflammation Reduction Trial.","AIMS


In epidemiologic cohorts initiated >30 years ago, inflammatory biomarkers, such as interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP) were shown to independently predict future cardiovascular events with a magnitude of effect comparable to that of low-density lipoprotein cholesterol (LDLC). Whether aggressive contemporary therapy for atherosclerosis has altered these relationships is unknown yet has major implications for future drug development.
METHODS AND RESULTS


Interleukin-6, hsCRP, and LDLC were measured at baseline in up to 4168 North American patients enrolled in the contemporary Cardiovascular Inflammation Reduction Trial with prior myocardial infarction or multivessel coronary disease who additionally had diabetes or metabolic syndrome and were followed for a period of up to 5 years for incident major recurrent cardiovascular events and all-cause mortality. Three-quarters of the cohort were previously revascularized and the great majority was taking statins, angiotensin blocking agents, beta-blockers, and antithrombotic agents. Participants were randomly allocated to low-dose methotrexate 15 mg weekly or to placebo. Randomized use of methotrexate had no effect on event rates nor plasma levels of IL-6, hsCRP, or LDL over time. Yet, baseline levels of IL-6, hsCRP, and LDLC were all predictors of major recurrent cardiovascular events; adjusted hazard ratios [HR; 95% confidence interval (CI)] for the lowest to highest baseline quartiles of IL-6 were 1.0 (referent), 1.66 (1.18-2.35), 1.92 (1.36-2.70), and 2.11 (1.49-2.99; P < 0.0001), while adjusted HRs for increasing quartiles of hsCRP were 1.0 (referent), 1.28 (0.92-1.79), 1.73 (1.25-2.38), and 1.79 (1.28-2.50; P < 0.0001) and adjusted HRs for increasing quartiles of LDLC were 1.0 (referent), 1.12 (0.78-1.62), 1.25 (0.87-1.79), and 2.38 (1.72-3.30; P < 0.0001). Effect estimates were not statistically different in these analyses for comparisons between IL-6, hsCRP, or LDLC, although IL-6 was the strongest predictor of all-cause mortality. The highest absolute risks were observed among those with elevated levels of both cholesterol and inflammation [HR 6.4 (95% CI 2.9-14.1) for those in the top quartiles of baseline IL-6 and LDLC, HR 4.9 (95% CI 2.6-9.4) for those in the top quartiles of baseline hsCRP and LDLC, both P < 0.0001].
CONCLUSION


Despite aggressive contemporary secondary prevention efforts, the relationships between inflammation, cholesterol, and cardiovascular risk are largely unchanged from those described two decades ago. These data are consistent with the hypothesis that future treatments for atherosclerosis may require a combination of inflammation inhibition and additional cholesterol reduction.
CLINICAL TRIAL


ClinicalTrials.gov NCT01594333.",2020,"Randomized use of methotrexate had no effect on event rates nor plasma levels of IL-6, hsCRP, or LDL over time.",['4168 North American patients enrolled in the contemporary Cardiovascular Inflammation Reduction Trial with prior myocardial infarction or multivessel coronary disease who additionally had diabetes or metabolic syndrome and were followed for a period of up to 5\u2009years for incident major recurrent cardiovascular events and all-cause mortality'],"['methotrexate 15\u2009mg weekly or to placebo', 'methotrexate', 'interleukin-6, C-reactive protein, and low-density lipoprotein cholesterol']","['cholesterol and inflammation', 'baseline levels of IL-6, hsCRP, and LDLC', 'event rates nor plasma levels of IL-6, hsCRP, or LDL over time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]","[{'cui': 'C1127565', 'cui_str': 'Methotrexate 15 MG'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.315218,"Randomized use of methotrexate had no effect on event rates nor plasma levels of IL-6, hsCRP, or LDL over time.","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Division of Preventive Medicine, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Brigham and Women's Hospital, Boston, MA 02215, USA.""}, {'ForeName': 'Jean G', 'Initials': 'JG', 'LastName': 'MacFadyen', 'Affiliation': ""Division of Preventive Medicine, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Brigham and Women's Hospital, Boston, MA 02215, USA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Preventive Medicine, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Brigham and Women's Hospital, Boston, MA 02215, USA.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Bradwin', 'Affiliation': ""Department of Laboratory Medicine, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Hasan', 'Affiliation': 'National Heart Lung and Blood Institute, 9000 Rockville Pike, Bethesda, MD 20892, USA.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Rifai', 'Affiliation': ""Department of Laboratory Medicine, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA 02115, USA.""}]",European heart journal,['10.1093/eurheartj/ehaa160']
329,32201122,"A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis.","PURPOSE


In patients with unilateral intra-articular temporomandibular joint (TMJ) pain, the efficacy of steroid supplementation compared with placebo after TMJ arthrocentesis was examined in a randomized, double-blind, placebo-controlled clinical trial.
PATIENTS AND METHODS


Female patients unsuccessfully treated by usual therapy were recruited. After informed consent was obtained, 24 patients were randomly assigned to either the experimental group or placebo group. After local anesthesia, TMJ arthrocentesis, consisting of joint lavage using 100 mL of lactated Ringer solution, was performed by a single investigator. Depending on group assignment, triamcinolone acetonide (steroid) or lactated Ringer solution (placebo) was infused into the superior joint space. Patients, blinded to the procedure, were evaluated at baseline and 2, 6, and 12 weeks after arthrocentesis using a visual analog scale for primary outcome pain measures (pain intensity, pain unpleasantness, and chewing pain). A clinical examination using the Research Diagnostic Criteria for Temporomandibular Disorders was performed at each time point by a separate calibrated, blinded examiner. Data were analyzed using an intention-to-treat model.
RESULTS


Significant decreases in visual analog scale pain scores over time were found between baseline and the post-arthrocentesis time points for both groups. The steroid group had significantly less chewing pain at 6 and 12 weeks than the placebo group. Mean maximum mandibular openings without pain or with pain were significantly greater at all post-arthrocentesis time points than at baseline in the steroid group, whereas the placebo group had a larger mandibular opening at 6 weeks. At 12 weeks, significantly more patients in the steroid group (75%) had a nearly normal mandibular opening without pain (38 mm) compared with the placebo group (20%). In addition, the proportion of patients with a greater than 50% improvement in chewing pain in the steroid group (90%) was significantly higher than that in the placebo group (<40%).
CONCLUSIONS


The results of this randomized controlled trial support steroid supplementation after TMJ arthrocentesis to achieve longer-lasting pain management and increased pain-free mandibular mobility.",2020,"Mean maximum mandibular openings without pain or with pain were significantly greater at all post-arthrocentesis time points than at baseline in the steroid group, whereas the placebo group had a larger mandibular opening at 6 weeks.","['24 patients', 'Female patients unsuccessfully treated by usual therapy were recruited', 'patients with unilateral intra-articular temporomandibular joint (TMJ) pain']","['Steroid Supplementation', 'placebo', 'steroid supplementation', 'lactated Ringer solution', 'Placebo', 'triamcinolone acetonide (steroid) or lactated Ringer solution (placebo']","['chewing pain', 'normal mandibular opening without pain', 'Mean maximum mandibular openings without pain or with pain', 'visual analog scale for primary outcome pain measures (pain intensity, pain unpleasantness, and chewing pain', 'visual analog scale pain scores', 'pain-free mandibular mobility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}]","[{'cui': 'C0699816', 'cui_str': 'Does chew (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",24.0,0.673487,"Mean maximum mandibular openings without pain or with pain were significantly greater at all post-arthrocentesis time points than at baseline in the steroid group, whereas the placebo group had a larger mandibular opening at 6 weeks.","[{'ForeName': 'M Franklin', 'Initials': 'MF', 'LastName': 'Dolwick', 'Affiliation': 'Professor and Academy 100 Eminent Scholar, Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Florida, Gainesville, FL.'}, {'ForeName': 'Daili', 'Initials': 'D', 'LastName': 'Diaz', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Florida, Gainesville, FL.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Freburg-Hoffmeister', 'Affiliation': 'Clinical Assistant Professor, Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Florida, Gainesville, FL.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Widmer', 'Affiliation': 'Associate Professor and Parker E. Mahan Facial Pain Endowed Professor, Department of Orthodontics, College of Dentistry, University of Florida, Gainesville, FL. Electronic address: widmer@dental.ufl.edu.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.02.022']
330,32098484,"Examination of using alcohol to cope, depressive symptoms, and perceived social support in persons with HIV and Hepatitis C.","Depression is common among people living with HIV (PLWH) and some likely turn to alcohol to cope with this emotional distress. Using alcohol to cope is associated with increased alcohol use, persistent longitudinal alcohol use, and alcohol-related problems. This association is particularly concerning among PLWH who are co-infected with Hepatitis C (HCV) because alcohol adds to the damage already caused by HCV. Despite data showing the associated risks of using alcohol to cope, scant research has examined factors that might contribute to coping-based alcohol use in HIV-HCV patients, such as limited social support. Baseline data from a randomized trial of strategies to reduce alcohol use in co-infected HIV and HCV adult patients (n=110) were analyzed. Multiple linear regression models were used to estimate the association between using alcohol to cope, depression, and four aspects of social support, controlling for demographic variables. Results showed that using alcohol to cope was not significantly correlated with social support but was significantly correlated with depressive symptoms. In fact, depressive symptoms and severity of alcohol consumption accounted for nearly 45% of the variance related to coping-based alcohol use. These data highlight the central role of depression in the coping motives-alcohol use relationship among co-infected patients.",2020,Results showed that using alcohol to cope was not significantly correlated with social support but was significantly correlated with depressive symptoms.,"['co-infected HIV and HCV adult patients (n=110', 'people living with HIV (PLWH', 'persons with HIV and Hepatitis C']",[],"['depressive symptoms', 'depressive symptoms and severity of alcohol consumption']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",110.0,0.014857,Results showed that using alcohol to cope was not significantly correlated with social support but was significantly correlated with depressive symptoms.,"[{'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Moitra', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence RI, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Behavioral Medicine and Addictions Research Unit, Butler Hospital, Providence RI, USA.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Herman', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence RI, USA.'}, {'ForeName': 'Jumi', 'Initials': 'J', 'LastName': 'Hayaki', 'Affiliation': 'Department of Psychology, College of the Holy Cross, Worcester MA, USA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Pinkston', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence RI, USA.'}, {'ForeName': 'H Nina', 'Initials': 'HN', 'LastName': 'Kim', 'Affiliation': 'Department of Global Health, University of Washington, Seattle WA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Stein', 'Affiliation': 'Department of Health Law, Policy and Management, Boston University School of Public Health, Boston MA, USA.'}]",AIDS care,['10.1080/09540121.2020.1734177']
331,32213342,"Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial.","BACKGROUND


Intravenous daratumumab for treatment of patients with multiple myeloma involves a lengthy infusion that affects quality of life, and infusion-related reactions are common. Subcutaneous daratumumab is thought to be easier to administer and to cause fewer administration-related reactions. In this study (COLUMBA), we tested the non-inferiority of subcutaneous daratumumab to intravenous daratumumab.
METHODS


In this ongoing, multicentre (147 sites in 18 countries), open-label, non-inferiority, randomised, phase 3 trial, we recruited adult patients (age ≥18 years) if they had confirmed relapsed or refractory multiple myeloma according to International Myeloma Working Group criteria; received at least three previous lines of therapy, including a proteasome inhibitor and immunomodulatory drug, or were double refractory to both a proteasome inhibitor and immunomodulatory drug; and had an Eastern Cooperative Oncology Group performance status score of 2 or lower. Patients were randomly assigned (1:1) by a computer-generated randomisation schedule and balanced using randomly permuted blocks to receive daratumumab subcutaneously (subcutaneous group) or intravenously (intravenous group). Randomisation was stratified on the basis of baseline bodyweight (≤65 kg, 66-85 kg, >85 kg), previous therapy lines (≤four vs >four), and myeloma type (IgG vs non-IgG). Patients received 1800 mg of subcutaneous daratumumab co-formulated with 2000 U/mL recombinant human hyaluronidase PH20 or 16 mg/kg of intravenous daratumumab once weekly (cycles 1-2), every 2 weeks (cycles 3-6), and every 4 weeks thereafter (28-day cycles) until progressive disease or toxicity. The co-primary endpoints were overall response and maximum trough concentration (C trough ; cycle 3, day 1 pre-dose). The non-inferiority margin for overall response was defined using a 60% retention of the lower bound (20·8%) of the 95% CI of the SIRIUS trial. Efficacy analyses were done by intention-to-treat population. The pharmacokinetic-evaluable population included all patients who received all eight weekly daratumumab doses in cycles 1 and 2 and provided a pre-dose pharmacokinetics blood sample on day 1 of cycle 3. The safety population included all patients who received at least one daratumumab dose. This trial is registered with ClinicalTrials.gov, NCT03277105.
FINDINGS


Between Oct 31, 2017, and Dec 27, 2018, 655 patients were screened, of whom 522 were recruited and randomly assigned (subcutaneous group n=263; intravenous group n=259). Three patients in the subcutaneous group and one in the intravenous group did not receive treatment and were not evaluable for safety. At a median follow-up of 7·5 months (IQR 6·5-9·3), overall response and C trough  met the predefined non-inferiority criteria. An overall response was seen in 108 (41%) of 263 patients in the subcutaneous group and 96 (37%) of 259 in the intravenous group (relative risk 1·11, 95% CI 0·89-1·37). The geometric means ratio for C trough  was 107·93% (90% CI 95·74-121·67), and the maximum C trough  was 593 μg/mL (SD 306) in the subcutaneous group and 522 μg/mL (226) in the intravenous group. The most common grade 3 and 4 adverse events were anaemia (34 [13%] of 260 patients evaluable for safety in the subcutaneous group and 36 [14%] of 258 patients in the intravenous group), neutropenia (34 [13%] and 20 [8%]), and thrombocytopenia (36 [14%] and 35 [14%]). Pneumonia was the only serious adverse event in more than 2% of patients (seven [3%] in the subcutaneous group and 11 [4%] in the intravenous group). There was one death resulting from a treatment-related adverse event in the subcutaneous daratumumab group (febrile neutropenia) and four in the intravenous group (sepsis [n=2], hepatitis B reactivation [n=1], and Pneumocystis jirovecii pneumonia [n=1]).
INTERPRETATION


Subcutaneous daratumumab was non-inferior to intravenous daratumumab in terms of efficacy and pharmacokinetics and had an improved safety profile in patients with relapsed or refractory multiple myeloma. These data could contribute to the approval of the subcutaneous daratumumab formulation by regulatory bodies.
FUNDING


Janssen Research & Development.",2020,"There was one death resulting from a treatment-related adverse event in the subcutaneous daratumumab group (febrile neutropenia) and four in the intravenous group (sepsis [n=2], hepatitis B reactivation [n=1], and Pneumocystis jirovecii pneumonia [n=1]).
","['adult patients (age ≥18 years) if they had confirmed relapsed or refractory multiple myeloma according to International Myeloma Working Group criteria', 'patients with relapsed or refractory multiple myeloma', 'patients with relapsed or refractory multiple myeloma (COLUMBA', 'patients with multiple myeloma', 'Between Oct 31, 2017, and Dec 27, 2018, 655 patients were screened, of whom 522 were recruited and randomly assigned (subcutaneous group n=263; intravenous group n=259']","['recombinant human hyaluronidase PH20 or 16 mg/kg of intravenous daratumumab', 'subcutaneous daratumumab co-formulated with 2000', 'U/mL', 'proteasome inhibitor and immunomodulatory drug, or were double refractory to both a proteasome inhibitor and immunomodulatory drug; and had an Eastern Cooperative Oncology Group performance status score of 2 or lower', 'daratumumab subcutaneously (subcutaneous group) or intravenously (intravenous group', 'Subcutaneous versus intravenous daratumumab']","['Pneumonia', 'anaemia', 'geometric means ratio for C trough', 'thrombocytopenia', 'neutropenia', 'overall response', 'overall response and maximum trough concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0999231', 'cui_str': 'Genus Columba'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517804', 'cui_str': 'Five hundred and twenty-two'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1720035', 'cui_str': 'hyaluronidase, human recombinant'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C1443643', 'cui_str': 'Proteasome Endopeptidase Complex Inhibitors'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",655.0,0.267856,"There was one death resulting from a treatment-related adverse event in the subcutaneous daratumumab group (febrile neutropenia) and four in the intravenous group (sepsis [n=2], hepatitis B reactivation [n=1], and Pneumocystis jirovecii pneumonia [n=1]).
","[{'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Cancer Research Unit, University Hospital of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain; Institute of Cancer Molecular and Cellular Biology (USAL-CSIC), Centre for Cancer Research (IBMCC), Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain.'}, {'ForeName': 'Hareth', 'Initials': 'H', 'LastName': 'Nahi', 'Affiliation': 'Unit of Hematology, Department of Medicine, Karolinska University Hospital at Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Legiec', 'Affiliation': 'Department of Hemato-Oncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, School of Public Health in Bytom, Medical University of Silesia in Katowice, Katowice, Poland.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vorobyev', 'Affiliation': 'S P Botkin City Clinical Hospital, Moscow, Russia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Spicka', 'Affiliation': '1st Department of Medicine, Department of Hematology, First Faculty of Medicine, Charles University, Prague, Czech Republic; General University Hospital in Prague, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Clinica São Germano, São Paulo, Brazil.'}, {'ForeName': 'Sibirina', 'Initials': 'S', 'LastName': 'Korenkova', 'Affiliation': 'Kiev Bone Marrow Transplantation Center, Kiev, Ukraine.'}, {'ForeName': 'Nizar', 'Initials': 'N', 'LastName': 'Bahlis', 'Affiliation': 'Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Flogegard', 'Affiliation': 'Department of Internal Medicine, Falun General Hospital, Falun, Sweden.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bladé', 'Affiliation': ""Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'Department of Haemato-Oncology, Royal Marsden Hospital, London, UK; Division of Molecular Pathology, Institute of Cancer Research, London, UK.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Laubach', 'Affiliation': 'Department of Hematology and Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Magen', 'Affiliation': 'Department of Hematology Chaim Sheba Medical Center, Ramat-Gan, Sackler Faculty of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Diagnostic and Specialty Medicine Department, Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Hulin', 'Affiliation': 'Centre Hospitalier Universitaire Bordeaux, Pessac, France.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'De Stefano', 'Affiliation': 'Institute of Hematology, Università Cattolica del Sacro Cuore, Rome, Italy; Fondazione Policlinico Universitario Agostino Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Clemens', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Masterson', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Lantz', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': ""O'Rourke"", 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Dolly A', 'Initials': 'DA', 'LastName': 'Parasrampuria', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Zhilong', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA; Genmab US, Princeton, NJ, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Levine Cancer Institute-Atrium Health, Charlotte, NC, USA. Electronic address: saad.usmani@atriumhealth.org.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30070-3']
332,31619429,"Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study.","INTRODUCTION


Rates of chronic conditions, such as diabetes, cardiovascular disease and obesity are increasing in Canada and internationally. There are effective lifestyle interventions that are known to improve chronic conditions. However, there is often a gap in 'how to' make lifestyle changes. Mental health and other determinants of health play a role in the development and progression of chronic conditions. Changing habits takes time and requires the use of multiple techniques, including mental health and behavioural change strategies, based on a person's needs. A new, multidisciplinary, person-centred and evidence-based and practice-based programme has been created to address these needs. This proposal aims to evaluate the feasibility and implementation of this programme and to determine changes in participant-directed and clinical outcomes through a pilot study.
METHODS AND ANALYSIS


A pragmatic mixed methods design will be used to study multiple dimensions of the year-long healthy lifestyles programme. The pilot study includes a randomised controlled trial, with 30 participants randomised to either the programme or to a comparator arm, and qualitative components to determine the feasibility of the programme, including recruitment and retention, data missing rates and resources needed to run this programme. Changes in participant-directed and clinical outcomes will be measured. Descriptive statistics, t-tests and repeated measures analysis of variance (ANOVA) for within group comparisons and generalised estimating equations for between group analyses will be used. Qualitative interviews of programme staff and healthcare providers and family focus groups will be used to further enhance the findings and improve the programme.
ETHICS AND DISSEMINATION


Approval from the Hamilton Integrated Research Ethics Board (HiREB) has been obtained. Informed consent will be obtained prior to enrolling any participant into the study. Participant IDs will be used during data collection and entry. Peer-reviewed publications and presentations will target researchers, health professionals and stakeholders.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Identifier: NCT03258138.HiREB project number: 3793.",2019,"A new, multidisciplinary, person-centred and evidence-based and practice-based programme has been created to address these needs.",['30 participants'],['healthy lifestyles program'],[],[],"[{'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.133235,"A new, multidisciplinary, person-centred and evidence-based and practice-based programme has been created to address these needs.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Alvarez', 'Affiliation': 'Centre for Health Economics and Policy Analysis (CHEPA), McMaster University, Hamilton, Ontario, Canada alvare@mcmaster.ca.'}, {'ForeName': 'Majdi', 'Initials': 'M', 'LastName': 'Qutob', 'Affiliation': 'Innovation Science and Medicine (ISM), Burlington, Ontario, Canada.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Mbuagbaw', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lavis', 'Affiliation': 'Centre for Health Economics and Policy Analysis (CHEPA), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Lokker', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Walli-Attaei', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Samaan', 'Affiliation': 'Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Sutton', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Japteg', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Feeny', 'Affiliation': 'Centre for Health Economics and Policy Analysis (CHEPA), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fortuna', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-031298']
333,32213642,Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline.,"OBJECTIVE


To determine the effect of low-dose aspirin vs placebo on incident all-cause dementia, incident Alzheimer disease (AD), mild cognitive impairment (MCI), and cognitive decline in older individuals.
METHODS


Aspirin in Reducing Events in the Elderly (ASPREE) was a double-blind, placebo-controlled trial of low-dose aspirin. In the United States and Australia, community-dwelling individuals aged ≥70 years (US minorities ≥65 years) and free of cardiovascular disease, physical disability, and diagnosed dementia were enrolled. Participants were randomized 1:1-100 mg daily aspirin or placebo. The Modified Mini-Mental State Examination, Hopkins Verbal Learning Test-Revised, Symbol Digit Modalities Test, and Controlled Oral Word Association Test assessed cognition at baseline and over follow-up. Additional cognitive testing was performed in participants with suspected dementia (""trigger"") based on within-study assessments or clinical history. Dementia was adjudicated according to DSM-IV criteria. National Institute on Aging-Alzheimer's Association criteria were used for AD and MCI subclassification.
RESULTS


A total of 19,114 participants were followed over a median 4.7 years and 964 triggered further dementia assessments. There were 575 adjudicated dementia cases, and 41% were classified as clinically probable AD. There was no substantial difference in the risk of all dementia triggers (hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.91-1.17), probable AD (HR, 0.96; 95% CI, 0.74-1.24), or MCI (HR, 1.12; 95% CI, 0.92-1.37) between aspirin and placebo. Cognitive change over time was similar in the aspirin and placebo groups.
CONCLUSIONS


There was no evidence that aspirin was effective in reducing risk of dementia, MCI, or cognitive decline. Follow-up of these outcomes after initial exposure is ongoing.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for healthy older individuals, low-dose aspirin does not significantly reduce the incidence of dementia, probable AD, MCI, or cognitive decline.
CLINICALTRIALSGOV IDENTIFIER


NCT01038583.",2020,"There was no substantial difference in the risk of all dementia triggers (hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.91-1.17), probable AD (HR, 0.96; 95% CI, 0.74-1.24), or MCI (HR, 1.12; 95% CI, 0.92-1.37) between aspirin and placebo.","['incident all-cause dementia, incident Alzheimer disease (AD), mild cognitive impairment (MCI), and cognitive decline in older individuals', 'healthy older individuals', 'A total of 19,114 participants were followed over a median 4.7 years and 964 triggered further dementia assessments', 'United States and Australia, community-dwelling individuals aged ≥70 years (US minorities ≥65 years) and free of cardiovascular disease, physical disability, and diagnosed dementia were enrolled', 'participants with suspected dementia (""trigger"") based on within-study assessments or clinical history']","['aspirin', 'Aspirin', 'placebo', 'aspirin or placebo', 'aspirin vs placebo']","['risk of all dementia triggers', 'Modified Mini-Mental State Examination, Hopkins Verbal Learning Test-Revised, Symbol Digit Modalities Test, and Controlled Oral Word Association Test assessed cognition', 'dementia and cognitive decline', 'Cognitive change over time', 'incidence of dementia, probable AD, MCI, or cognitive decline', 'risk of dementia, MCI, or cognitive decline']","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451522', 'cui_str': 'Symbol Digit Modalities Test'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}]",19114.0,0.630076,"There was no substantial difference in the risk of all dementia triggers (hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.91-1.17), probable AD (HR, 0.96; 95% CI, 0.74-1.24), or MCI (HR, 1.12; 95% CI, 0.92-1.37) between aspirin and placebo.","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL. elsdon.storey@monash.edu joanne.ryan@monash.edu.""}, {'ForeName': 'Elsdon', 'Initials': 'E', 'LastName': 'Storey', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL. elsdon.storey@monash.edu joanne.ryan@monash.edu.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Trevor T J', 'Initials': 'TTJ', 'LastName': 'Chong', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Ward', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Trevaks', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000009277']
334,32214229,A randomized evaluation of vinorelbine versus gemcitabine chemotherapy mobilization of stem cells in myeloma patients.,,2020,,['myeloma patients'],"['gemcitabine chemotherapy mobilization', 'vinorelbine']",[],"[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]",[],,0.0452301,,"[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Jeker', 'Affiliation': 'Department of Medical Oncology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Farag', 'Affiliation': 'Department of Medical Oncology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Behrouz Mansouri', 'Initials': 'BM', 'LastName': 'Taleghani', 'Affiliation': 'Department of Hematology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Novak', 'Affiliation': 'Department of Medical Oncology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Beatrice U', 'Initials': 'BU', 'LastName': 'Mueller', 'Affiliation': 'Department of Clinical Research, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Qiyu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'SAKK Coordinating Centre, Bern, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Betticher', 'Affiliation': 'Department of Oncology, Kantonsspital, Fribourg, Switzerland.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Luethi', 'Affiliation': 'Department of Oncology, Regionalspital, Thun, Switzerland.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Farese', 'Affiliation': 'Department of Oncology, Kantonsspital, Solothurn, Switzerland.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Ruefer', 'Affiliation': 'Department of Hematology, Kantonsspital, Lucerne, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bacher', 'Affiliation': 'Department of Hematology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Department of Medical Oncology, Inselspital, University Hospital and University of Bern, Bern, Switzerland. thomas.pabst@insel.ch.'}]",Bone marrow transplantation,['10.1038/s41409-020-0875-8']
335,31714506,Effects of Expressing Writing on organizational variables in Palliative Care health Professionals: an explorative study.,"BACKGROUND AND AIM


Healthcare professionals working in palliative care are exposed to emotionally intense conditions. Scientific literature suggests Expressive Writing as a valid tool for the adjustment to traumatic events. For health workers, EW represents an important support to prevent Compassion Fatigue and Burnout. As literature showed that Compassion Satisfaction, Group Cohesion and the Organizational Commitment are protective factors able to counter the onset of Compassion Fatigue and Burnout, the aim of this study is evaluating the effect of Expressive Writing protocol in Palliative Care workers on Compassion Satisfaction, Group Cohesion and Organizational Commitment.
METHODS


A quasi-experimental quantitative 2x2 prospective study was conducted with two groups and two measurements. 66 professionals were included. Outcome variables were measured using: Organizational Commitment Questionnaire, Compassion Satisfaction Rating Scale, ICONAS Questionnaire, Questionnaire for the evaluation of EW sessions.
RESULTS


The parametric analysis through Student t test did not show statistical significance within the experimental group and between the experimental and control groups. One significant difference in the pre-intervention assessment of Normative Commitment t (gl 64) = -2.008 for p< 0.05, higher in the control group, disappeared in the post intervention evaluation. An improvement trend in all variables within and between groups was present, with a positive assessment of utility from the participants.
CONCLUSIONS


This intervention did not significantly impact outcome variables. It is however conceivable that by modifying the intervention methodology, it could prove effective. The positive evaluation by the operators, suggests to keep trying modelling a protocol tailored on Palliative Care professionals.",2019,The parametric analysis through Student t test did not show statistical significance within the experimental group and between the experimental and control groups.,"['66 professionals were included', 'Palliative Care health Professionals']","['Expressive Writing protocol', 'Expressing Writing']","['Organizational Commitment Questionnaire, Compassion Satisfaction Rating Scale, ICONAS Questionnaire, Questionnaire for the evaluation of EW sessions']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",66.0,0.0595422,The parametric analysis through Student t test did not show statistical significance within the experimental group and between the experimental and control groups.,"[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cosentino', 'Affiliation': 'University of Parma. chiara.cosentino1@unipr.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Corte', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fioresi', 'Affiliation': ''}, {'ForeName': 'Fiorella', 'Initials': 'F', 'LastName': 'Molina Ojeda', 'Affiliation': ''}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pastore', 'Affiliation': ''}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Severgnini', 'Affiliation': ''}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Spacci', 'Affiliation': ''}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Artioli', 'Affiliation': ''}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v90i11-S.8946']
336,31494365,Time to relapse after a single administration of intravenous ketamine augmentation in unipolar treatment-resistant depression.,"OBJECTIVE


To examine the rate and time to relapse for remitters and responders to ketamine in treatment-resistant depression (TRD).
METHODS


Subjects with TRD were randomized to a single infusion of one of several doses of intravenous ketamine, or midazolam. Using Kaplan-Meier survival function, the current report examines the rate and time to relapse, defined as MADRS ≥ 22, over a period of 30 days, in subjects who achieved remission (MADRS ≤ 10) or response (≥ 50% reduction in MADRS) on day three post-infusion of intravenous ketamine 0.1, 0.5, or 1.0 mg/kg.
RESULTS


Of the 60 randomized participants who received a single ketamine (0.1, 0.5, or 1.0 mg/kg) infusion, 19 (34%) met criteria for remission and 27 (48%) for response, on day 3 post-infusion. A numerical dose-response relationship was observed, with remitters/responders on ketamine 1.0 mg/kg having the lowest relapse rate, followed by ketamine 0.5 mg/kg and 0.1 mg/kg, respectively (% of remitters who relapsed by day 14: 38% with 1.0 mg/kg, 50% with 0.5 mg/kg, 100% with 0.1 mg/kg;% of responders who relapsed by day 14: 30% with 1.0 mg/kg, 50% with 0.5 mg/kg, 80% with 0.1 mg/kg).
LIMITATIONS


The sample size was small. No MADRS measurements at day one post-infusion. The study was not powered to assess differences in relapse prevention between different doses of ketamine.
CONCLUSION


Time to relapse after successful treatment with a single infusion of ketamine appears to follow a dose-response relationship, where higher dosage leads to increased time to relapse.",2020,"A numerical dose-response relationship was observed, with remitters/responders on ketamine 1.0 mg/kg having the lowest relapse rate, followed by ketamine 0.5 mg/kg and 0.1 mg/kg, respectively (% of remitters who relapsed by day 14: 38% with 1.0 mg/kg, 50% with 0.5 mg/kg, 100% with 0.1 mg/kg;% of responders who relapsed by day 14: 30% with 1.0 mg/kg, 50% with 0.5 mg/kg, 80% with 0.1 mg/kg).
","['Subjects with TRD', 'unipolar treatment-resistant depression']","['ketamine', 'ketamine, or midazolam', 'single ketamine']","['relapse prevention', 'rate and time to relapse']","[{'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",60.0,0.150738,"A numerical dose-response relationship was observed, with remitters/responders on ketamine 1.0 mg/kg having the lowest relapse rate, followed by ketamine 0.5 mg/kg and 0.1 mg/kg, respectively (% of remitters who relapsed by day 14: 38% with 1.0 mg/kg, 50% with 0.5 mg/kg, 100% with 0.1 mg/kg;% of responders who relapsed by day 14: 30% with 1.0 mg/kg, 50% with 0.5 mg/kg, 80% with 0.1 mg/kg).
","[{'ForeName': 'Naji C', 'Initials': 'NC', 'LastName': 'Salloum', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA; Clinical Trials Network and Institute, Massachusetts General Hospital, USA. Electronic address: nchaayasalloum@mgh.harvard.edu.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA; Clinical Trials Network and Institute, Massachusetts General Hospital, USA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Hock', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA; Clinical Trials Network and Institute, Massachusetts General Hospital, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA; Clinical Trials Network and Institute, Massachusetts General Hospital, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, Nathan Kline Institute, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'The University of Texas Southwestern Medical Center, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale School of Medicine, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine and Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, USA; Clinical Trials Network and Institute, Massachusetts General Hospital, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2019.09.017']
337,32086791,Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy: A Subgroup Analysis of Patients ≥ 65 Years of Age.,"BACKGROUND


Opioid-induced constipation (OIC), the most common side effect of opioid treatment, is under-recognized and undertreated in older patients. Naldemedine, an oral, peripherally acting μ-opioid receptor antagonist (PAMORA), is approved in Japan, the United States, and the European Union for treatment of OIC in adult patients.
OBJECTIVE


This integrated analysis of three phase 3 trials (COMPOSE-1, COMPOSE-2, and COMPOSE-3) evaluated the safety and efficacy of naldemedine for up to 12 weeks in a subgroup of patients aged ≥ 65 years.
METHODS


Patients aged 18-80 years with chronic non-cancer pain for ≥ 3 months (treated with opioids for ≥ 3 months in COMPOSE-1 and COMPOSE-2) and OIC received oral naldemedine 0.2 mg or placebo once daily. Safety assessments included overall incidence of treatment-emergent adverse events (TEAEs), TEAEs in the gastrointestinal disorders System Organ Class, and TEAEs of opioid withdrawal or possible opioid withdrawal. Efficacy was based on the proportion of responders in COMPOSE-1 and COMPOSE-2, defined as having ≥ 3 spontaneous bowel movements/week and a ≥ 1-spontaneous bowel movement/week increase from baseline for ≥ 9 of 12 weeks and ≥ 3 of the last 4 weeks.
RESULTS


A total of 14.8% (344/2328) of patients were aged ≥ 65 years in all studies. The incidence of TEAEs in naldemedine-treated patients aged ≥ 65 years (45.9%) was comparable to that in patients aged ≥ 65 years receiving placebo (51.6%) and in the overall naldemedine group (47.1%). The incidence of gastrointestinal disorders System Organ Class TEAEs in naldemedine-treated patients aged ≥ 65 years (20.2%) was also comparable to that in patients aged ≥ 65 years receiving placebo (16.1%) and in the overall naldemedine group (21.8%). The incidence of TEAEs of opioid withdrawal with naldemedine was 1.1% in patients aged ≥ 65 years and 1.0% overall, and the incidence of TEAEs of possible opioid withdrawal was 1.1% in patients aged ≥ 65 years and 1.7% overall. The proportion of responders was higher in naldemedine-treated patients versus placebo, both overall (50.1% vs 34.1%; p < 0.0001) and in those aged ≥ 65 years (51.8% vs 37.6%).
CONCLUSIONS


This integrated analysis confirmed that OIC treatment with naldemedine 0.2 mg was generally well tolerated and effective in patients aged ≥ 65 years with chronic non-cancer pain. Safety and efficacy results were consistent with the overall patient population. CLINICALTRIALS.
GOV REGISTRATION


NCT01965158, NCT01993940, NCT01965652.",2020,This integrated analysis confirmed that OIC treatment with naldemedine 0.2 mg was generally well tolerated and effective in patients aged ≥ ,"['older patients', 'A total of 14.8% (344/2328) of patients were aged\u2009≥', 'adult patients', 'Patients aged 18-80\xa0years with chronic non-cancer pain for\u2009≥', 'patients aged\u2009≥', '65\xa0years with chronic non-cancer pain', 'Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy', 'naldemedine-treated patients aged\u2009≥']","['placebo', 'naldemedine', 'oral naldemedine 0.2\xa0mg or placebo', 'Naldemedine']","['Safety and Efficacy', 'Efficacy', 'incidence of TEAEs of opioid withdrawal with naldemedine', 'proportion of responders', 'overall incidence of treatment-emergent adverse events (TEAEs), TEAEs in the gastrointestinal disorders System Organ Class, and TEAEs of opioid withdrawal or possible opioid withdrawal', 'tolerated and effective', 'safety and efficacy', 'Safety and efficacy', 'incidence of TEAEs of possible opioid withdrawal']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4325235', 'cui_str': 'naldemedine'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4325235', 'cui_str': 'naldemedine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4325237', 'cui_str': 'naldemedine 0.2 MG'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0029104', 'cui_str': 'Opioid withdrawal (disorder)'}, {'cui': 'C4325235', 'cui_str': 'naldemedine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",,0.205418,This integrated analysis confirmed that OIC treatment with naldemedine 0.2 mg was generally well tolerated and effective in patients aged ≥ ,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wild', 'Affiliation': 'Upstate Clinical Research Associates, 8201 Main Street, Suite 1, Williamsville, NY, 14221, USA. jwild@roadrunner.com.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Webster', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Tadaaki', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Shionogi Inc., Florham Park, NJ, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hale', 'Affiliation': 'Gold Coast Research LLC, Plantation, FL, USA.'}]",Drugs & aging,['10.1007/s40266-020-00753-2']
338,31050715,"Alleviating Social Pain: A Double-Blind, Randomized, Placebo-Controlled Trial of Forgiveness and Acetaminophen.","BACKGROUND


Research has suggested that physical pain (e.g., caused by injury) and social pain (e.g., caused by social rejection) are modulated by some of the same biological systems. Consequently, it is possible that acetaminophen, which is commonly used to alleviate physical pain through neurochemical pathways, may have social pain-relieving effects that interact with forgiveness, which reduces social pain through psychological pathways. To date, however, only a few studies have examined how experiences of social pain change over time, and none have examined how acetaminophen and forgiveness interact to influence these effects.
PURPOSE


We addressed these issues by investigating how acetaminophen administration and daily forgiveness are associated with experiences of social pain over 21 days. We hypothesized that acetaminophen-related reductions in social pain across the 21-day study period would be greatest on days following high levels of forgiveness.
METHOD


To test this hypothesis, we conducted a double-blind, randomized, placebo-controlled trial in which we randomly assigned 42 healthy young adults to an acetaminophen condition (1,000 mg of acetaminophen daily), placebo-control condition (400 mg of potassium daily), or empty-control (no pill) condition. We then assessed their levels of forgiveness and social pain for 20 consecutive days.
RESULTS


As hypothesized, acetaminophen reduced participants' social pain levels over time but only for those exhibiting high levels of forgiveness (i.e., 18.5% reduction in social pain over 20 days).
CONCLUSIONS


These data are the first to show that forgiveness and acetaminophen have interactive effects on experiences of social pain, which is one of the most common and impactful of all human experiences.",2019,"As hypothesized, acetaminophen reduced participants' social pain levels over time but only for those exhibiting high levels of forgiveness (i.e., 18.5% reduction in social pain over 20 days).
",['42 healthy young adults to an'],"['placebo', 'acetaminophen condition (1,000 mg of acetaminophen daily), placebo-control condition (400 mg of potassium daily), or empty-control (no pill) condition', 'Placebo', 'Acetaminophen', 'acetaminophen']","['Alleviating Social Pain', 'levels of forgiveness and social pain', 'social pain', 'social pain levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0871753', 'cui_str': 'Forgivenesses'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",42.0,0.289852,"As hypothesized, acetaminophen reduced participants' social pain levels over time but only for those exhibiting high levels of forgiveness (i.e., 18.5% reduction in social pain over 20 days).
","[{'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Slavich', 'Affiliation': 'Cousins Center for Psychoneuroimmunology and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Shields', 'Affiliation': 'Department of Psychology, University of California, Davis, CA, USA.'}, {'ForeName': 'Bailey D', 'Initials': 'BD', 'LastName': 'Deal', 'Affiliation': 'Department of Psychology, University of California, Davis, CA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Gregory', 'Affiliation': 'Department of Psychology, Luther College, Decorah, IA, USA.'}, {'ForeName': 'Loren L', 'Initials': 'LL', 'LastName': 'Toussaint', 'Affiliation': 'Department of Psychology, Luther College, Decorah, IA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz015']
339,32212342,Nucleus Hybrid S12: Multicenter Clinical Trial Results.,"OBJECTIVES/HYPOTHESIS


The use of a short 10-mm/10-electrode cochlear implant to preserve low-frequency residual hearing was investigated. This report describes the 12-month outcomes of this multicenter clinical trial.
STUDY DESIGN


Single-subject design.
METHODS


Twenty-eight subjects with low-frequency hearing at or better than 60 dB HL at 500 Hz and severe high-frequency hearing loss were implanted with a Nucleus Hybrid S12 implant in their poorer ear. Speech perception in quiet using Consonant-Nucleus-Consonant (CNC) words and sentences in noise using AzBio sentences was collected pre- and postoperatively at 3, 6, and 12 months. Subjective reporting using the Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire was also collected pre- and postoperatively.
RESULTS


Functional hearing preservation was accomplished in 96% of subjects. At 3 and 6 months, 86% of the 28 subjects had maintained functional hearing. By 12 months, 23 out of 27 subjects (85%) had maintained functional hearing (one subject with functional hearing at 6 months withdrew from the study prior to the 12-month visit). Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids. Furthermore, preoperative to 12 months postoperative subjective ratings showed significant improvements for the SSQ.
CONCLUSIONS


This study demonstrates that a high degree of hearing preservation enabling acoustic-electric hearing and improvement in speech understanding in quiet and in noise can be accomplished using a short-electrode 10-mm cochlear implant.
LEVEL OF EVIDENCE


2c Laryngoscope, 130:E548-E558, 2020.",2020,Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids.,"['Nucleus Hybrid S12', 'Twenty-eight subjects with low-frequency hearing at or better than 60\u2009dB HL at 500\u2009Hz and severe high-frequency hearing loss were implanted with a Nucleus Hybrid S12 implant in their poorer ear']",['hearing preservation enabling acoustic-electric hearing'],"['Subjective reporting using the Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire', 'Functional hearing preservation', 'Speech perception', 'Speech perception in quiet using Consonant-Nucleus-Consonant (CNC) words and sentences in noise using AzBio sentences', 'maintained functional hearing', 'everyday listening condition']","[{'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439498', 'cui_str': 'decibel hearing level'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018780', 'cui_str': 'Hearing Loss, High-Frequency'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}]","[{'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",28.0,0.0168716,Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids.,"[{'ForeName': 'Camille C', 'Initials': 'CC', 'LastName': 'Dunn', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Oleson', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Parkinson', 'Affiliation': 'Cochlear Americas, Centennial, Colorado, U.S.A.'}, {'ForeName': 'Marlan R', 'Initials': 'MR', 'LastName': 'Hansen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Gantz', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}]",The Laryngoscope,['10.1002/lary.28628']
340,32205547,Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial.,"BACKGROUND


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


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


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


Among intermediate-risk patients having orthopedic surgery with general anesthesia, fluid administration guided by the plethysmographic variability index did not shorten the duration of hospitalization or reduce complications.",2020,Plethysmographic-guided fluid management did not reduce the duration of hospitalization or complications in moderate-risk surgery patients.,"['Adult patients in sinus rhythm having elective orthopedic surgery (knee or hip arthroplasty) under general anesthesia were enrolled', '447 moderate-risk major arthroplasty patients to', 'intermediate-risk patients having orthopedic surgery with general anesthesia', '447 patients were randomized, and 438 were included in the analysis', 'moderate-risk surgery patients', 'five hospitals']","['Plethysmographic-guided fluid management', 'plethysmographic-guided versus routine fluid management', 'Individualized Fluid Management']","['theoretical postoperative hospital length of stay', 'postoperative arterial lactate measurements', 'duration of hospitalization or reduce complications', 'serious postoperative cardiac complications', 'postoperative hospital length of stay and morbidity', 'acute postoperative renal failure', 'duration of hospitalization or complications', 'mean hospital length of stay ± SD', 'postoperative hospital length of stay decided by surgeons blinded to the group allocation of the patient', 'Fitness for discharge and actual hospital durations', 'troponin Ic concentration', 'noninvasive plethysmographic variability index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0553741', 'cui_str': 'Hydration control'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0340276', 'cui_str': 'Postoperative cardiac complication (disorder)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2585625', 'cui_str': 'Acute postoperative renal failure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",447.0,0.161995,Plethysmographic-guided fluid management did not reduce the duration of hospitalization or complications in moderate-risk surgery patients.,"[{'ForeName': 'Marc-Olivier', 'Initials': 'MO', 'LastName': 'Fischer', 'Affiliation': 'From the Anesthesiology and Critical Care Medicine Department (M.-O.F., S.L., W.G., G.D., J.-L.H.) the INSERM COMETE 1075 Unit, Orthopedic Department, (C.H.) the Biostatistics Department (J.-J.P.), Normandy University, Caen University Hospital, Caen, France Anesthesiology and Critical Care Medicine Department, Lille University Hospital, Lille, France (B.T., M.H.) Anesthesiology and Intensive Care Medicine Department, Hospital of Catholic Institute of Lille, Saint Philibert Hospital, Lomme, France (C.-E.B., V.C.) Anesthesiology and Critical Care Medicine Department, Rouen University Hospital, Charles Nicolle Hospital, Rouen, France (V.C.) Anesthesiology and Critical Care Department, Amiens University Hospital, Amiens, France (D.T., E.L.) Research Unit on Simplified Care of Complex Surgical Patients, Jules Verne University of Picardy, Amiens, France (E.L.). Caen University Hospital, Caen, France Caen University Hospital, Caen, France Amiens Picardie University Hospital, Amiens, France Amiens Picardie University Hospital, Amiens, France Lille University Hospital, Lille, France Lille University Hospital, Lille, France Hospital of Catholic Institute of Lille, Lomme, France Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Hospital of Catholic Institute of Lille Clinical Research Department, Lille University Hospital Clinical Research Department, Lille University Hospital Clinical Research Department, Amiens Picardie University Hospital.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lemoine', 'Affiliation': ''}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Tavernier', 'Affiliation': ''}, {'ForeName': 'Chems-Eddine', 'Initials': 'CE', 'LastName': 'Bouchakour', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Colas', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Houard', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Greub', 'Affiliation': ''}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Daccache', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Hulet', 'Affiliation': ''}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Compère', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Taing', 'Affiliation': ''}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Lorne', 'Affiliation': ''}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': ''}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003260']
341,32208844,Impact of Treatment Delay on Outcome in the International Subarachnoid Aneurysm Trial.,"Background and Purpose- ISAT (International Subarachnoid Aneurysm Trial) demonstrated that 1 year after aneurysmal subarachnoid hemorrhage, coiling resulted in a significantly better clinical outcome than clipping. After 5 years, this difference did not reach statistical significance, but mortality was still higher in the clipping group. Here, we present additional analyses, reporting outcome after excluding pretreatment deaths. Methods- Outcome measures were death with or without dependency at 1 and 5 years after treatment, after exclusion of all pretreatment deaths. Treatment differences were assessed using relative risks (RRs). With sensitivity and exploratory analyses, the relation between treatment delay and outcome was analyzed. Results- After exclusion of pretreatment deaths, at 1-year follow-up coiling was favorable over clipping for death or dependency (RR, 0.77 [95% CI, 0.67-0.89]) but not for death alone (RR, 0.88 [95% CI, 0.66-1.19]). After 5 years, no significant differences were observed, neither for death or dependency (RR, 0.88 [95% CI, 0.77-1.02]) nor for death alone (RR, 0.82 [95% CI, 0.64-1.05]). Sensitivity analyses showed a similar picture. In good-grade patients, coiling remained favorable over clipping in the long-term. Time between randomization and treatment was significantly longer in the clipping arm (mean 1.7 versus 1.1 days;  P <0.0001), during which 17 patients died because of rebleeding versus 6 pretreatment deaths in the endovascular arm (RR, 2.81 [95% CI, 1.11-7.11]). Conclusions- These additional analyses support the conclusion of ISAT that at 1-year follow-up after aneurysmal subarachnoid hemorrhage coiling has a better outcome than clipping. After 5 years, with pretreatment mortality excluded, the difference between coiling and clipping is not significant. The high number of pretreatment deaths in the clipping group highlights the importance of urgent aneurysm treatment to prevent early rebleeding.",2020,"After 5 years, no significant differences were observed, neither for death or dependency (RR, 0.88",[],"['Conclusions', ' and Purpose- ISAT', 'Methods']","['mortality', 'relative risks (RRs', 'death or dependency', 'death with or without dependency']",[],"[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}]",,0.305041,"After 5 years, no significant differences were observed, neither for death or dependency (RR, 0.88","[{'ForeName': 'Carlina E', 'Initials': 'CE', 'LastName': 'van Donkelaar', 'Affiliation': 'From the Department of Neurosurgery (C.E.v.D., N.A.B., J.M.C.v.D.), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Nicolaas A', 'Initials': 'NA', 'LastName': 'Bakker', 'Affiliation': 'From the Department of Neurosurgery (C.E.v.D., N.A.B., J.M.C.v.D.), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Birks', 'Affiliation': 'Center for Statistics in Medicine, Oxford, United Kingdom (J.B.).'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford University Hospitals Foundation NHS Trust, United Kingdom (A.C., M.S., A.J.M.).'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sneade', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford University Hospitals Foundation NHS Trust, United Kingdom (A.C., M.S., A.J.M.).'}, {'ForeName': 'Richard S C', 'Initials': 'RSC', 'LastName': 'Kerr', 'Affiliation': 'Department of Neurosurgery, John Radcliffe Hospital, Oxford, United Kingdom (R.S.C.K.).'}, {'ForeName': 'Nic J G M', 'Initials': 'NJGM', 'LastName': 'Veeger', 'Affiliation': 'Department of Epidemiology (N.J.G.M.V.), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'J Marc C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'From the Department of Neurosurgery (C.E.v.D., N.A.B., J.M.C.v.D.), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Molyneux', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford University Hospitals Foundation NHS Trust, United Kingdom (A.C., M.S., A.J.M.).'}]",Stroke,['10.1161/STROKEAHA.120.028993']
342,30308286,Monitoring alcohol use in heavy drinking soup kitchen attendees.,"Rates of heavy alcohol use in soup kitchen attendees range from 30% to 38%, but these data are based entirely on self-reported drinking. Little is known about the intensity or frequency of drinking in this population. We assessed alcohol use transdermally every 30 min over a 3-week period among heavy drinkers who attended local soup kitchens. In addition to transdermal alcohol monitoring, participants were randomly assigned to daily breath alcohol monitoring with or without reinforcement for alcohol-negative breath samples (BrAC). Analyses assessed feasibility of transdermal monitoring and examined alcohol use based on BrAC, transdermal, and self-report data, as well as effect sizes for these metrics based on group assignment. Nineteen participants completed the 21-day monitoring period in full; three persons removed the anklet 3-16 days early due to hospitalization, impending hospitalization, or incarceration. Participants reported minimal impacts of the monitors, and severity ratings of side effects were mild. When using BrAC, transdermal, and self-report data, the percentage of non-drinking days was 93%, 58%, and 57%, and the longest duration of consecutive non-drinking days averaged 10.3, 7.2, and 5.7 days, respectively. About half of drinking days involved heavy drinking (5 + drinks). Self-report and transdermal drinking days correlated significantly, p < .001, but neither index was associated with BrAC. Group comparisons indicate small-to-moderate sized effects of reinforcement compared to no reinforcement for increasing the proportion of alcohol-negative breath samples and durations of consecutive non-drinking samples during the study when BrAC was the metric. Transdermal data and self-report data indicated a more complex pattern. Reinforcement participants drank more often but at lower quantities than monitoring (control) participants per both transdermal and self-report data. These data suggest that transdermal monitors are well tolerated and document substantial heavy drinking in this population. Soup kitchens users are in need of alcohol interventions, and soup kitchens may represent a novel opportunistic setting for intervention delivery for an important and growing health disparities population.",2019,"Self-report and transdermal drinking days correlated significantly, p < .001, but neither index was associated with BrAC.","['Heavy Drinking Soup Kitchen Attendees', 'Nineteen participants completed the 21-day monitoring period in full; three persons removed the anklet 3-16 days early due to hospitalization, impending hospitalization, or incarceration', 'heavy drinkers who attended local soup kitchens']",['daily breath alcohol monitoring with or without reinforcement for alcohol-negative breath samples (BrAC'],['heavy drinking'],"[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0453399', 'cui_str': 'Soup (substance)'}, {'cui': 'C0557653', 'cui_str': 'Kitchen (environment)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0179081', 'cui_str': 'Anklet'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0332190', 'cui_str': 'Impending (qualifier value)'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment (finding)'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0277982', 'cui_str': 'Smell of alcohol on breath (finding)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",19.0,0.0139378,"Self-report and transdermal drinking days correlated significantly, p < .001, but neither index was associated with BrAC.","[{'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Rash', 'Affiliation': 'UConn Health School of Medicine, Farmington, CT, United States. Electronic address: Carlarash@gmail.com.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Petry', 'Affiliation': 'UConn Health School of Medicine, Farmington, CT, United States.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Alessi', 'Affiliation': 'UConn Health School of Medicine, Farmington, CT, United States.'}, {'ForeName': 'Nancy P', 'Initials': 'NP', 'LastName': 'Barnett', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Providence, RI, United States.'}]","Alcohol (Fayetteville, N.Y.)",['10.1016/j.alcohol.2018.10.001']
343,31543516,"Calcium: magnesium intake ratio and colorectal carcinogenesis, results from the prostate, lung, colorectal, and ovarian cancer screening trial.","BACKGROUND


We aimed to evaluate the associations between calcium and various stages of colorectal carcinogenesis and whether these associations are modified by the calcium to magnesium (Ca:Mg) ratio.
METHODS


We tested our hypotheses in the prostate lung, colorectal and ovarian cancer screening trial.
RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05). This inverse trend was mainly in participants with Ca:Mg ratios between 1.7 and 2.5 (P- trend  = 0.05). No significant associations were observed for metachronous adenoma. Calcium intake was inversely associated with CRC (P- trend  = 0.03); the association was primarily present for distal CRC (P- trend  = 0.01). The inverse association between calcium and distal CRC was further modified by the Ca:Mg ratio (P- interaction  < 0.01); significant dose-response associations were found only in participants with a Ca:Mg ratio between 1.7 and 2.5 (P- trend  = 0.04). No associations for calcium were found in the Ca:Mg ratio above 2.5 or below 1.7.
CONCLUSION


Higher calcium intake may be related to reduced risks of incident advanced and/or synchronous adenoma and incident distal CRC among subjects with Ca:Mg intake ratios between 1.7 and 2.5.",2019,"RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05).","['subjects with Ca', 'participants with Ca']",['Calcium: magnesium'],"['Calcium intake', 'Mg intake ratios', 'metachronous adenoma']",[],"[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0489458', 'cui_str': 'Calcium intake (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",,0.0314611,"RESULTS


Calcium intake did not show a dose-response association with incident adenoma of any size/stage (P- trend  = 0.17), but followed an inverse trend when restricted to synchronous/advanced adenoma cases (P- trend  = 0.05).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Ayush', 'Initials': 'A', 'LastName': 'Giri', 'Affiliation': 'Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Xiangzhu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Shrubsole', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Yixing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Medicine, Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Xingyi', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Ness', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Seidner', 'Affiliation': 'Department of Medicine, Vanderbilt Center for Human Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Giovannucci', 'Affiliation': 'Departments of Nutrition and Epidemiology, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Todd L', 'Initials': 'TL', 'LastName': 'Edwards', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Division of Epidemiology, Vanderbilt Ingram Cancer Center, Department of Medicine, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. qi.dai@vanderbilt.edu.'}]",British journal of cancer,['10.1038/s41416-019-0579-2']
344,31036542,"Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial.","PURPOSE


In phase I/II studies, nelipepimut-S (NP-S) plus GM-CSF vaccine was well tolerated and effectively raised HER2-specific immunity in patients with breast cancer. Results from a prespecified interim analysis of a phase III trial assessing NP-S + GM-CSF are reported.
PATIENTS AND METHODS


This multicenter, randomized, double-blind phase III study enrolled females ≥18 years with T1-T3, HER2 low-expressing (IHC 1+/2+), node-positive breast cancer in the adjuvant setting. Patients received 1,000 μg NP-S + 250 μg GM-CSF or placebo + GM-CSF monthly for 6 months, then every 6 months through 36 months. The primary objective was disease-free survival (DFS). Protocol-specified imaging occurred annually. New abnormalities were categorized as recurrence events; biopsy confirmation was not mandated. The interim analysis was conducted as specified in the protocol after 73 DFS events.
RESULTS


A total of 758 patients (mean age 51.8 years) were randomized. Adverse events were similar between groups; most common were injection-associated: erythema (84.3%), induration (55.8%), and pruritus (54.9%). There was no significant between-arms difference in DFS events at interim analysis at median follow-up (16.8 months). In the NP-S arm, imaging detected 54.1% of recurrence events in asymptomatic patients versus 29.2% in the placebo arm ( P  = 0.069).
CONCLUSIONS


NP-S was well tolerated. There was no significant difference in DFS events between NP-S and placebo. Use of mandated annual scans and image-detected recurrence events hastened the interim analysis contributing to early trial termination.",2019,"Adverse events were similar between groups; most common were injection-associated: erythema (84.3%), induration (55.8%), and pruritus (54.9%).","['Breast Cancer Recurrence', 'enrolled females ≥18 years with T1-T3, HER2 low-expressing (IHC 1+/2+), node-positive breast cancer in the adjuvant setting', 'patients with breast cancer', '758 patients (mean age 51.8 years']","['Nelipepimut-S Vaccine', '1,000 μg NP-S + 250 μg GM-CSF or placebo + GM-CSF', 'nelipepimut-S (NP-S) plus GM-CSF vaccine', 'placebo']","['Adverse events', 'tolerated', 'erythema', 'recurrence events', 'disease-free survival (DFS', 'DFS events']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",758.0,0.378502,"Adverse events were similar between groups; most common were injection-associated: erythema (84.3%), induration (55.8%), and pruritus (54.9%).","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mittendorf', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts. emittendorf@bwh.harvard.edu.""}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Independent Statistical Contractor, San Ramon, California.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Melisko', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Price Hiller', 'Affiliation': 'Division of Medical Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Department of Oncology and Medical Radiology, Dnipropetrovsk State Medical Academy, Dnipropetrovsk, Ukraine.'}, {'ForeName': 'Adrian Murray', 'Initials': 'AM', 'LastName': 'Brunt', 'Affiliation': 'Cancer Centre, University Hospitals of North Midlands and Keele University, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Grybach', 'Initials': 'G', 'LastName': 'Sergii', 'Affiliation': 'Kyiv Regional Oncologic Dispensary, Kyiv, Ukraine.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Petrakova', 'Affiliation': 'Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Peoples', 'Affiliation': 'Cancer Insight, San Antonio, Texas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2867']
345,32192596,Androgenicity and fertility treatment in women with unexplained infertility.,"OBJECTIVE


To determine whether biochemical or clinical markers of androgenic activity predict live birth rate with ovarian stimulation in the unexplained infertility population.
DESIGN


Secondary analysis of the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial.
SETTING


Multicenter university-based clinical practices.
PATIENT(S)


Nine hundred couples with unexplained infertility were included. Women were 18-40 years old with regular menses, a normal uterine cavity, at least one patent fallopian tube, and a male partner with ≥5 million motile sperm. Women were randomized to receive gonadotropin, clomiphene, or letrozole with IUI for four or fewer four treatment cycles. Women were evaluated for biochemical (total testosterone, DHEAS, and free androgen index) and clinical markers of androgenic activity (sebum, acne, and hirsutism). Multivariable logistic regression models adjusting for treatment group, maternal age, and body mass index were performed.
INTERVENTION(S)


None.
MAIN OUTCOME MEASURE(S)


The primary outcome was live birth. Secondary outcomes included conception, clinical pregnancy, and pregnancy loss.
RESULT(S)


When comparing 900 women in the AMIGOS trial based on quartiles of serum TT, women were of younger age, higher body mass index, and higher waist circumference with increasing TT. Increasing quartiles of TT also showed increasing DHEAS and free androgen index values. Serum androgens were not associated with outcomes of live birth, conception, clinical pregnancy, or pregnancy loss. Clinical androgen markers were not associated with pregnancy outcomes.
CONCLUSION(S)


In a randomized cohort of women with unexplained infertility, biochemical and clinical measures of androgens did not predict live birth rate after ovarian stimulation treatment.
CLINICAL TRIAL REGISTRATION NUMBER


NCT 01044862.",2020,"In a randomized cohort of women with unexplained infertility, biochemical and clinical measures of androgens did not predict live birth rate after ovarian stimulation treatment.
","['women with unexplained infertility', '900 women in the AMIGOS trial based on quartiles of serum TT, women were of younger age, higher body mass index, and higher waist circumference with increasing TT', 'Women were 18-40 years old with regular menses, a normal uterine cavity, at least one patent fallopian tube, and a male partner with ≥5 million motile sperm', 'Multicenter university-based clinical practices', '\n\n\nNine hundred couples with unexplained infertility were included']","['gonadotropin, clomiphene, or letrozole', 'ovarian stimulation']","['biochemical (total testosterone, DHEAS, and free androgen index) and clinical markers of androgenic activity (sebum, acne, and hirsutism', 'conception, clinical pregnancy, and pregnancy loss', 'live birth rate', 'Serum androgens', 'live birth', 'DHEAS and free androgen index values', 'live birth, conception, clinical pregnancy, or pregnancy loss', 'Androgenicity and fertility treatment']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0227844', 'cui_str': 'Endometrial cavity structure'}, {'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C4301985', 'cui_str': 'Motile spermatozoa'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0008963', 'cui_str': 'Markers, Clinical'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",900.0,0.40248,"In a randomized cohort of women with unexplained infertility, biochemical and clinical measures of androgens did not predict live birth rate after ovarian stimulation treatment.
","[{'ForeName': 'Erica T', 'Initials': 'ET', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: erica.wang@cshs.org.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Alvero', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Casson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Christman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.'}, {'ForeName': 'Fangbai', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Randal D', 'Initials': 'RD', 'LastName': 'Robinson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Health San Antonio Long School of Medicine, San Antonio, Texas.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Usadi', 'Affiliation': 'Department of Obstetrics and Gynecology, Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Margareta D', 'Initials': 'MD', 'LastName': 'Pisarska', 'Affiliation': 'Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Nanette F', 'Initials': 'NF', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2019.10.034']
346,31655801,Percutaneous Coronary Intervention Does Not Lower Cardiovascular Outcomes in Patients with Chronic Kidney Disease.,"BACKGROUND


Chronic kidney disease (CKD) is associated with an increased risk of adverse cardiovascular outcomes, in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, most studies used bare-metal stents or first-generation drug-eluting stents, and less guideline-directed therapy to reduce cardiovascular risk was reported in CKD patients. This study investigates the impact of moderate-CKD on patients undergoing PCI in the current era.
METHODS


Patient level data were pooled from 2 multicenter randomized trials (BIONICS and NIREUS trials) with a near ""all-comers"" design, comparing PCI with ridaforolimus-eluting stents vs. zotarolimus-eluting stents in patients with CAD. Patients were classified according to the presence or absence of moderate-CKD, defined as creatinine clearance (CrCl) <60 mL/min. We compared baseline characteristics, angiographic findings, and clinical outcomes 1-year post-PCI.
RESULTS


236/2,201 (10.7%) patients had CKD, mean CrCl of 50.3 + 7.8 mL/min. These patients were generally older and more often with hypertension than non-CKD patients, but the use of guideline-directed therapy was similar between the groups. CKD was associated with an increased risk of cardiovascular death (hazard ratio [HR] 6.08; 95% CI 2.11-17.51; p < 0.001), but with a reduced occurrence of repeated revascularization, including ischemia-driven revascularization (HR 0.47; 95% CI 0.24-0.92; p < 0.05). The rate of repeated angiography per severe cardiovascular adverse event was significantly lower in the CKD than the non-CKD group (23/38 [61%] vs. 253/334 [76%], p < 0.05).
CONCLUSIONS


Moderate-CKD in patients with CAD was associated with higher rates of all-cause and cardiovascular mortality, yet with a lower risk of revascularization 1-year following PCI. Lack of guideline-directed medical therapy does not explain the adverse outcome of CKD patients.",2019,"CKD was associated with an increased risk of cardiovascular death (hazard ratio [HR] 6.08; 95% CI 2.11-17.51; p < 0.001), but with a reduced occurrence of repeated revascularization, including ischemia-driven revascularization (HR 0.47; 95% CI 0.24-0.92; p < 0.05).","['patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI', 'patients undergoing PCI in the current era', 'Patients with Chronic Kidney Disease', 'patients with CAD', 'Patient level data', 'Chronic kidney disease (CKD', 'CKD patients']","['Percutaneous Coronary Intervention', 'PCI with ridaforolimus-eluting stents vs. zotarolimus-eluting stents']","['rate of repeated angiography per severe cardiovascular adverse event', 'occurrence of repeated revascularization, including ischemia-driven revascularization', 'cardiovascular risk', 'Cardiovascular Outcomes', 'risk of cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C2713007', 'cui_str': 'ridaforolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1700035', 'cui_str': 'zotarilumus'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.105356,"CKD was associated with an increased risk of cardiovascular death (hazard ratio [HR] 6.08; 95% CI 2.11-17.51; p < 0.001), but with a reduced occurrence of repeated revascularization, including ischemia-driven revascularization (HR 0.47; 95% CI 0.24-0.92; p < 0.05).","[{'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Chernin', 'Affiliation': 'Department of Nephrology and Hypertension, Kaplan Medical Center, Hebrew University School of Medicine, Rehovot, Israel, chernin4@gmail.com.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Cardiovascular Research Foundation, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Ozgu', 'Initials': 'O', 'LastName': 'Ozan', 'Affiliation': 'Cardiovascular Research Foundation, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Cardiovascular Research Foundation, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Haberman', 'Affiliation': 'Department of Cardiology, Kaplan Medical Center, Hebrew University School of Medicine, Rehovot, Israel.'}, {'ForeName': 'Gidon', 'Initials': 'G', 'LastName': 'Perlman', 'Affiliation': 'Medinol Ltd, Tel-Aviv, Israel.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Cardiovascular Research Foundation, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jonas', 'Affiliation': 'Department of Cardiology, Kaplan Medical Center, Hebrew University School of Medicine, Rehovot, Israel.'}]",American journal of nephrology,['10.1159/000503916']
347,32207667,Predictors and moderators of response to brief interventions among adolescents with risky alcohol and marijuana use.,"Background:  Brief interventions have shown promise in reducing adolescent alcohol and marijuana use. This manuscript presents a secondary analysis of a randomized trial that compared a brief parent motivational intervention (Family Check Up; FCU) to brief psychoeducation (PE) condition and found no effect of treatment condition on either binge drinking or marijuana use days. The current analyses explored whether the response to treatment may have varied as a function of six empirically-based baseline moderators and predictors: biological sex, age, race/ethnicity, mental health problems, parent-adolescent communication, and peer deviance.  Methods:  Data from the parent trial randomizing 102 parents to either the FCU ( n  = 51) or PE ( n  = 51) interventions were re-analyzed across four time points (baseline, 3-, 6-, and 12-months). Moderators and predictors were tested via a series of hierarchical linear models.  Results:  Parent-adolescent communication and peer deviance emerged as significant predictors of adolescent treatment response. Specifically, low-levels of parent-adolescent communication or peer deviance were associated with worse treatment response (i.e., significant  increases  in binge drinking days and marijuana use days) in the PE condition, but not in the FCU condition. Non-Hispanic Whites and girls had worse treatment response, regardless of treatment condition.  Conclusions:  The FCU condition appeared to mitigate risks of poor parent-adolescent communication and affiliation with deviant peers better than the PE condition. Clinical recommendations for decision-making around assignment to brief interventions are discussed.",2020,"Hispanic Whites and girls had worse treatment response, regardless of treatment condition.  ","['102 parents to either the FCU ( n \u2009=\u200951) or PE ( n \u2009=\u200951) interventions', 'Hispanic Whites and girls', 'adolescents with risky alcohol and marijuana use']",['parent motivational intervention (Family Check Up; FCU'],['low-levels of parent-adolescent communication or peer deviance'],"[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4316909', 'cui_str': 'Marijuana Use'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",102.0,0.0201499,"Hispanic Whites and girls had worse treatment response, regardless of treatment condition.  ","[{'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Becker', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Marceau', 'Affiliation': 'Department of Human Development and Family Studies, Purdue University, West Lafayette, Indiana, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Helseth', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Hernandez', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Department of Psychiatry and Human Behavior, The Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}]",Substance abuse,['10.1080/08897077.2020.1742271']
348,32150855,The Effect of Ultraviolet B Irradiation Compared with Oral Vitamin D Supplementation on the Well-being of Nursing Home Residents with Dementia: A Randomized Controlled Trial.,"There are indications that ultraviolet B (UVB) exposure has beneficial effects on well-being through mechanisms other than vitamin D synthesis alone. We conducted a randomized controlled multicenter trial to compare the effects of UVB light and vitamin D supplementation (VD) in terms of the well-being of nursing home residents with dementia. Participants were randomly assigned to the intervention group (UVB group,  n  = 41; half-body UVB irradiation, twice weekly over 6 months, with 1 standard erythema dose (SED)) or to the control group (VD group,  n  = 37; 5600 International units (IU) cholecalciferol supplementation once a week). The main outcome was well-being, measured by the Cohen-Mansfield Agitation Inventory (CMAI) and the Cornell scale for depression in dementia at 0, 3, and 6 months. Secondary outcomes were QUALIDEM quality of life domains and biochemical parameters of bone homeostasis. Intention-to-treat analysis with linear mixed modeling showed no significant between-group differences on agitation ( p  = 0.431) or depressive symptoms ( p  = 0.982). At six months, the UVB group showed less restless/tense behavior compared to the VD group (mean difference of the mean change scores 2.2, 95% CI 0.8 to 3.6;  p  = 0.003 for group x time interaction) and lower serum 25(OH)D3 concentration (estimated mean difference - 21.9, 95% CI -32.6 to -11.2;  p  = 0.003 for group difference). The exposure of nursing home residents with dementia to UVB light showed no positive benefits in terms of wellbeing. UVB treatment may have a positive effect on the restless/tense behavior characteristic of advanced dementia but more research is needed to confirm this finding.",2020,Intention-to-treat analysis with linear mixed modeling showed no significant between-group differences on agitation ( p  = 0.431) or depressive symptoms ( p  = 0.982).,"['Nursing Home Residents with Dementia', 'nursing home residents with dementia']","['intervention group (UVB group,  n  = 41; half-body UVB irradiation, twice weekly over 6 months, with 1 standard erythema dose (SED)) or to the control group (VD group,  n  = 37; 5600 International units (IU) cholecalciferol supplementation', 'ultraviolet B (UVB', 'UVB light and vitamin D supplementation (VD', 'Oral Vitamin D Supplementation', 'Ultraviolet B Irradiation']","['serum 25(OH)D3 concentration', 'quality of life domains and biochemical parameters of bone homeostasis', 'well-being, measured by the Cohen-Mansfield Agitation Inventory (CMAI) and the Cornell scale for depression in dementia', 'restless/tense behavior', 'agitation', 'depressive symptoms']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517812', 'cui_str': '5600 (qualifier value)'}, {'cui': 'C0439453', 'cui_str': 'IU'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034380'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3887611', 'cui_str': 'Restlessness (finding)'}, {'cui': 'C0235108', 'cui_str': 'Feeling tense (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.184294,Intention-to-treat analysis with linear mixed modeling showed no significant between-group differences on agitation ( p  = 0.431) or depressive symptoms ( p  = 0.982).,"[{'ForeName': 'Bistra I', 'Initials': 'BI', 'LastName': 'Veleva', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Monique A A', 'Initials': 'MAA', 'LastName': 'Caljouw', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Jenny T', 'Initials': 'JT', 'LastName': 'van der Steen', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Bart J A', 'Initials': 'BJA', 'LastName': 'Mertens', 'Affiliation': 'Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Victor G M', 'Initials': 'VGM', 'LastName': 'Chel', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands.'}, {'ForeName': 'Mattijs E', 'Initials': 'ME', 'LastName': 'Numans', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17051684']
349,31898142,Capsule Commentary on Neto et al.: Effects of a Required Large-Group Mindfulness Meditation Course on First-Year Medical Students' Mental Health and Quality of Life: a Randomized Controlled Trial.,,2020,,"[""First-Year Medical Students' Mental Health and Quality of Life""]",['Required Large-Group Mindfulness Meditation Course'],[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034380'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",[],,0.0929093,,"[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Padrino', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, OH, USA. Susan.padrino@uhhospitals.org.'}]",Journal of general internal medicine,['10.1007/s11606-019-05382-z']
350,32209712,Clinical Efficacy of Vibrating Mesh and Jet Nebulizers With Different Interfaces in Pediatric Subjects With Asthma.,"BACKGROUND


Nebulizers are commonly used in emergency departments to deliver bronchodilators to children with asthma exacerbations. However, no clinical study comparing a vibrating mesh nebulizer with a jet nebulizer is available in this patient population. The purpose of this study was to compare the clinical efficacy of a vibrating mesh nebulizer to a jet nebulizer combined with a mouthpiece or mask in children with asthma exacerbations admitted to the emergency department.
METHODS


We conducted a single-blinded randomized clinical trial of 217 children (2-18 y old) with a moderate to severe asthma exacerbation in the emergency department. Assessment of severity was defined by our acute asthma score, adapted from the Pediatric Asthma Score. Subjects were randomized to receive bronchodilator treatment via vibrating mesh nebulizer ( n  = 108) or jet nebulizer ( n =  109) and were treated until they achieved a mild asthma score and were discharged or until a decision to admit was made. All subjects were treated per our acute asthma clinical pathway algorithm for the emergency department with modifications to allow for blinding, assessment of treatment, and data collection. Outcome variables included hospital admission rate, number of treatments, and time to mild asthma score.
RESULTS


There was a significant difference in baseline asthma score between subjects treated with the vibrating mesh nebulizer and those treated with the jet nebulizer ( P  = .042), but no other significant differences in demographics existed between groups. To adjust for effect of baseline asthma score, a multiple logistic regression model was used to model admission. The vibrating mesh nebulizer group had a lower probability of being admitted to the hospital ( P  = .062), and they required significantly fewer treatments ( P  < .001) and less time to reach a mild asthma score ( P  = .004) than those in the jet nebulizer group. In subjects with a mask interface, the vibrating mesh nebulizer significantly reduced the probability of admission ( P  = .032).
CONCLUSIONS


Subjects treated with a vibrating mesh nebulizer required significantly fewer treatments and less time to achieve a mild asthma score. In subjects with a mask interface, the vibrating mesh nebulizer significantly reduced the probability of admission compared to jet nebulizer. (ClinicalTrials.gov registration NCT02774941.).",2020,"The vibrating mesh nebulizer group had a lower probability of being admitted to the hospital ( P  = .062), and they required significantly fewer treatments ( P  < .001) and less time to reach a mild asthma score ( P  = .004) than those in the jet nebulizer group.","['217 children (2-18 y old) with a moderate to severe asthma exacerbation in the emergency department', 'children with asthma exacerbations admitted to the emergency department', 'Pediatric Subjects With Asthma', 'All subjects were treated per our acute asthma clinical pathway algorithm for the emergency department with modifications to allow for blinding, assessment of treatment, and data collection', 'children with asthma exacerbations']","['bronchodilator treatment via vibrating mesh nebulizer ( n  = 108) or jet nebulizer', 'vibrating mesh nebulizer to a jet nebulizer combined with a mouthpiece or mask', 'Vibrating Mesh and Jet Nebulizers']","['probability of being admitted to the hospital', 'time to achieve a mild asthma score', 'baseline asthma score', 'time to reach a mild asthma score', 'probability of admission', 'clinical efficacy', 'hospital admission rate, number of treatments, and time to mild asthma score']","[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0582415', 'cui_str': 'Acute asthma (disorder)'}, {'cui': 'C0282654', 'cui_str': 'Clinical Pathways'}, {'cui': 'C0002045'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0027524', 'cui_str': 'Nebulizers'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",217.0,0.0530595,"The vibrating mesh nebulizer group had a lower probability of being admitted to the hospital ( P  = .062), and they required significantly fewer treatments ( P  < .001) and less time to reach a mild asthma score ( P  = .004) than those in the jet nebulizer group.","[{'ForeName': 'Gerald B', 'Initials': 'GB', 'LastName': 'Moody', 'Affiliation': ""Department of Respiratory Care, Children's Health - Children's Medical Center, Dallas, Texas. gerald.moody@childrens.com.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Luckett', 'Affiliation': 'Department of Pediatrics, Division of Critical Care Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Shockley', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, UT Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': ""Research Administration, Children's Health - Children's Medical Center, Dallas, Texas.""}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Ari', 'Affiliation': 'Department of Respiratory Care, Texas State University, Round Rock, Texas.'}]",Respiratory care,['10.4187/respcare.07538']
351,30855691,A Positive Mood Induction for Reducing the Formation of Nocebo Effects from Side Effect Information.,"BACKGROUND


Providing treatment side effect information can increase the occurrence of side effects through nocebo effects. Nocebo effects from side effect information raise a dilemma for health care, as there is an ethical obligation to disclose potential unpleasant treatment information to patients.
PURPOSE


To test the hypothesis that a positive mood induction can block the development of nocebo effects that result from treatment side effect information.
METHODS


In a laboratory setting, healthy participants were assigned to one of four conditions in a between-subjects randomized factorial trial. First, participants took part in a mood induction procedure, with half receiving a positive mood induction and the other half a neutral mood induction. Next, participants were told they would experience transcranial direct current stimulation (tDCS). Prior to a sham tDCS task, half of the participants were informed that headache pain is a side effect of tDCS, whereas the other half were not given this information.
RESULTS


In the neutral mood condition, the provision of headache side effect information lead to a greater occurrence of headaches, more frequent headaches, and a higher maximum level of headache pain as compared to those given no side effect information. In the positive mood condition, a similar increase in headache pain did not manifest from the provision of side effect information.
CONCLUSIONS


This is the first experiment to find that a positive mood induction can block the formation of nocebo effects that arise from side effect information. Inducing positive moods may be an effective strategy for reducing nocebo effects in a variety of clinical settings.",2019,"In the neutral mood condition, the provision of headache side effect information lead to a greater occurrence of headaches, more frequent headaches, and a higher maximum level of headache pain as compared to those given no side effect information.",['healthy participants'],['experience transcranial direct current stimulation (tDCS'],['headache pain'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0506517,"In the neutral mood condition, the provision of headache side effect information lead to a greater occurrence of headaches, more frequent headaches, and a higher maximum level of headache pain as compared to those given no side effect information.","[{'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Geers', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Close', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Fawn C', 'Initials': 'FC', 'LastName': 'Caplandies', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vase', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus C, Denmark.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz005']
352,31452038,Effects of a Required Large-Group Mindfulness Meditation Course on First-Year Medical Students' Mental Health and Quality of Life: a Randomized Controlled Trial.,"BACKGROUND


Teaching mindfulness techniques has been used in the attempt to prevent mental health problems in medical students. Although it has already shown promising results when offered to volunteers, the use as a required strategy is still controversial.
OBJECTIVES


To verify the efficacy of teaching mindfulness techniques to large groups when made part of a required discipline at the beginning of medical training.
DESIGN


Randomized controlled trial PARTICIPANTS: First-year medical students at the Federal University of Juiz de Fora, Brazil METHOD: Students were randomized into two groups: an intervention group (receiving a 6-week mindfulness protocol) and a control group (given a 6-week course containing organizational aspects of the medical school).
MAIN MEASURES


Intervention and control groups were compared on the levels of quality of life (WHOQOL-Bref), stress, anxiety and depression (DASS 21) and the facets of mindfulness (FFMQ) at baseline and at the end of the intervention.
RESULTS


A total of 141 students were included in the study, 70 in the intervention group and 71 in the control group. No significant differences were found between the intervention and control groups in all mental health, quality of life, and FFMQ scores (Cohen's d = 0.01 to 0.14). Likewise, no significant gains in mental health measures, quality of life, and FFMQ were identified in the intervention group when compared with the control group (Cohen's d = 0.02 to 0.33).
CONCLUSIONS


The incorporation of a required mindfulness course for large groups in the curriculum during the first semester of medical training was not associated with an improvement on medical students' mental health and quality of life.
CLINICAL TRIALS REGISTRATION


NCT03132597.",2020,"No significant differences were found between the intervention and control groups in all mental health, quality of life, and FFMQ scores (Cohen's d = 0.01 to 0.14).","[' First-year medical students at the Federal University of Juiz de Fora', 'A total of 141 students were included in the study, 70 in the intervention group and 71 in the control group', 'medical students', ""First-Year Medical Students' Mental Health and Quality of Life""]","['Required Large-Group Mindfulness Meditation Course', 'intervention group (receiving a 6-week mindfulness protocol) and a control group (given a 6-week course containing organizational aspects of the medical school']","[""medical students' mental health and quality of life"", 'levels of quality of life (WHOQOL-Bref), stress, anxiety and depression (DASS 21) and the facets of mindfulness (FFMQ', 'mental health measures, quality of life, and FFMQ', 'mental health, quality of life, and FFMQ scores']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034380'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0036378', 'cui_str': 'Schools, Medical'}]","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034380'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0332992,"No significant differences were found between the intervention and control groups in all mental health, quality of life, and FFMQ scores (Cohen's d = 0.01 to 0.14).","[{'ForeName': 'Afonso', 'Initials': 'A', 'LastName': 'Damião Neto', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Alessandra Lamas Granero', 'Initials': 'ALG', 'LastName': 'Lucchetti', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Oscarina', 'Initials': 'O', 'LastName': 'da Silva Ezequiel', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Lucchetti', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil. g.lucchetti@yahoo.com.br.'}]",Journal of general internal medicine,['10.1007/s11606-019-05284-0']
353,32206903,"Efficacy and safety of generic exenatide injection in Chinese patients with type 2 diabetes: a multicenter, randomized, controlled, non-inferiority trial.","AIMS


This study aimed to compare the efficacy and safety of generic exenatide with branded exenatide Byetta ®  in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on monotherapy or combination therapy of metformin and insulin secretagogues.
METHODS


A multicenter, randomized, controlled, non-inferiority trial was performed. A total of 240 patients with T2DM and glycated hemoglobin (HbA1c) ≥ 7% (53 mmol/mol) to ≤ 9.0% (75 mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3 months were randomized into generic exenatide or branded exenatide groups with a 1:1 ratio for 16 weeks of treatment. The primary endpoint was the change in HbA1c levels from baseline at week 16, with a non-inferiority margin of - 0.35% (- 3.83 mmol/mol) (lower bound of one-sided 95% confidence interval (CI) > - 0.35% (- 3.83 mmol/mol)). Secondary endpoints included the proportion of participants achieving HbA1c < 7% (53 mmol/mol), the changes in fasting plasma glucose (FPG), 2-h postprandial glucose (2hPG) following a standard meal, 7-point self-monitoring blood glucose (SMBG) profiles, body weight change from baseline at week 16 and the change in HbA1c levels from baseline at week 8. Safety issues were also evaluated.
RESULTS


After 16 weeks of treatment, HbA1c levels decreased significantly from baseline in the two groups, with a reduction of - 1.10% ± 1.31% (- 12.0 mmol/mol ± 14.3 mmol/mol) in the generic exenatide group and - 1.08% ± 1.11% (- 11.8 mmol/mol ± 12.1 mmol/mol) in the branded exenatide group (both P < 0.001). The least-squares mean difference of HbA1c reduction between the two groups was - 0.03% (- 0.33 mmol/mol), with a lower one-sided 95% CI limit of - 0.27% (- 2.95 mmol/mol), which was higher than the prespecified non-inferiority margin of - 0.35% (- 3.83 mmol/mol). Moreover, there were no significant differences in the proportion of participants achieving HbA1c < 7% (53 mmol/mol) and the changes in FPG, 2hPG, 7-point SMBG profiles and body weight at week 16 and the change in HbA1c levels from baseline at week 8 (all P > 0.05) between the two groups. The incidence of adverse events, including the incidence of hypoglycemia (18.3% and 17.5%, respectively), was similar for the generic and branded exenatide groups (P > 0.05).
CONCLUSIONS


In patients with T2DM inadequately controlled on monotherapy or combination therapy of metformin and insulin secretagogues, add-on treatment with generic exenatide demonstrated non-inferiority to branded exenatide in terms of improvements in HbA1c after 16 weeks of treatment. Furthermore, the two drugs were also similar for other efficacy endpoints and safety profile. Trial registration Chinese Clinical Trial Registry: ChiCTR-IPR-15006558, Date registered May 27, 2015.",2020,"The incidence of adverse events, including the incidence of hypoglycemia (18.3% and 17.5%, respectively), was similar for the generic and branded exenatide groups (P > 0.05).
","['Chinese patients with type 2 diabetes mellitus (T2DM', '240 patients with T2DM and glycated hemoglobin (HbA1c)\u2009≥\u20097% (53\xa0mmol/mol) to\u2009≤\u20099.0% (75\xa0mmol/mol) on monotherapy or combination therapy of metformin and insulin secretagogues for at least 3\xa0months', 'Chinese patients with type 2 diabetes']","['metformin', 'generic exenatide with branded exenatide Byetta ®', 'generic exenatide injection', 'generic exenatide or branded exenatide']","['incidence of hypoglycemia', 'Efficacy and safety', 'efficacy endpoints and safety profile', 'efficacy and safety', 'proportion of participants achieving HbA1c\u2009<\u20097% (53\xa0mmol/mol), the changes in fasting plasma glucose (FPG), 2-h postprandial glucose (2hPG) following a standard meal, 7-point self-monitoring blood glucose (SMBG) profiles, body weight change', 'changes in FPG, 2hPG, 7-point SMBG profiles and body weight', 'HbA1c levels', 'HbA1c reduction', 'change in HbA1c levels', 'incidence of adverse events']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4704833', 'cui_str': 'Secretagogues'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1636686', 'cui_str': 'Byetta'}, {'cui': 'C4026823', 'cui_str': 'exenatide Injection [Bydureon]'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0444664', 'cui_str': 'Standard meal (finding)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",240.0,0.123472,"The incidence of adverse events, including the incidence of hypoglycemia (18.3% and 17.5%, respectively), was similar for the generic and branded exenatide groups (P > 0.05).
","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ""Department of Endocrinology, Beijing Hospital, Beijing, 100730, People's Republic of China.""}, {'ForeName': 'Quanmin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, PLA Rocket Force Characteristic Medical Center, Beijing, 100088, People's Republic of China.""}, {'ForeName': 'Liyong', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Endocrinology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China.""}, {'ForeName': 'Jinkui', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, The First Hospital of Shanxi Medical University, Taiyuan, 030001, People's Republic of China.""}, {'ForeName': 'Yongyi', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""Department of Endocrinology, People's Hospital of Hainan Province, Haikou, 570311, People's Republic of China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, People's Republic of China.""}, {'ForeName': 'Tianpei', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, People's Republic of China. tpho66@bjmu.edu.cn.""}]",Acta diabetologica,['10.1007/s00592-020-01510-y']
354,32402585,Body weight of individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention.,"BACKGROUND & AIMS


The effect of pasta consumption within a low-energy Mediterranean diet on body weight regulation has been scarcely explored. This paper investigates the effect of two Mediterranean diets, which differed for lower or higher pasta intake, on body weight change in individuals with obesity.
METHODS & RESULTS


Forty-nine volunteers finished a quasi-experimental 6-month two-parallel group dietary intervention. Participants were assigned to a low-energy high pasta (HP) or to a low-energy low Pasta (LP) group on the basis of their pasta intake (HP ≥ 5 or LP ≤ 3 times/week). Anthropometrics, blood pressure and heart rate were measured every month. Weight maintenance was checked at month 12. Body composition (bioelectrical impedance analysis, BIA), food intake (24-h recall plus a 7-day carbohydrate record) and the perceived quality of life (36-item short-form health survey, SF-36) were assessed at baseline, 3 and 6 months. Blood samples were collected at baseline and month 6 to assess glucose and lipid metabolism. After 6-month intervention, body weight reduction was -10 ± 8% and -7 ± 4% in HP and LP diet, respectively, and it remained similar at month 12. Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups. No differences were observed for blood pressure and heart rate between treatments and among times. HP diet significantly improved perception of quality of life for the physical component.
CONCLUSIONS


Independent of pasta consumption frequency, low-energy Mediterranean diets were successful in improving anthropometrics, physiological parameters and dietary habits after a 6-month weight-loss intervention. This trial was registered at clinicaltrials.gov as NCT03341650.",2020,"Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups.","['Forty-nine volunteers finished a quasi-experimental 6-month two-parallel group dietary intervention', 'individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention', 'individuals with obesity']","['low-energy high pasta (HP) or to a low-energy low Pasta (LP', 'HP diet', 'Mediterranean diets']","['perception of quality of life', 'Weight maintenance', 'blood pressure and heart rate', 'anthropometrics, physiological parameters and dietary habits', 'glucose and lipid metabolism', 'Blood samples', 'Body weight', 'anthropometric parameters, body composition, glucose and lipid metabolism', 'Anthropometrics, blood pressure and heart rate', 'Body composition (bioelectrical impedance analysis, BIA), food intake (24-h recall plus a 7-day carbohydrate record) and the perceived quality of life (36-item short-form health survey, SF-36', 'body weight reduction']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0162536', 'cui_str': 'Biolectric Impedance'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",49.0,0.0258637,"Both dietary interventions improved anthropometric parameters, body composition, glucose and lipid metabolism, but no significant differences were observed between treatment groups.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Rosi', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Tesan', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Annalaura', 'Initials': 'A', 'LastName': 'Cremonini', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Biasini', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Bicchieri', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cossu', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Brighenti', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': ""Dall'Aglio"", 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Scazzina', 'Affiliation': 'Department of Food & Drugs, University of Parma, Parma, Italy. Electronic address: francesca.scazzina@unipr.it.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.02.013']
355,32272022,Circulating MicroRNAs and Treatment Response in Childhood Asthma.,"Rationale:  Inhaled corticosteroids (ICS) are key treatments for controlling asthma and preventing asthma attacks. However, the responsiveness to ICS varies among individuals. MicroRNAs (miRNAs) have been lauded for their prognostic utility. Objectives:  We hypothesized that circulating miRNAs obtained at baseline/prerandomization in the Childhood Asthma Management Program (CAMP) could serve as biomarkers and biologic mediators of ICS clinical response over the 4-year clinical trial period. Methods:  We selected baseline serum samples from 462 CAMP subjects subsequently randomized to either ICS (budesonide) or placebo. Samples underwent small RNA sequencing, and read counts were normalized and filtered by depth and coverage. Linear regression was used to associate miRNAs with change in FEV 1 % (prebronchodilator FEV 1  as a percent predicted) over the 4-year treatment period in both main effects and interaction models. We validated the function of the top associated miRNAs by luciferase reporter assays of glucocorticoid-mediated transrepression and predicted response to ICS through logistic regression models. Measurements and Main Results:  We identified 7 miRNAs significantly associated with FEV 1 % change ( P  ≤ 0.05) and 15 miRNAs with significant interaction ( P  ≤ 0.05) to ICS versus placebo treatments. We selected three miRNAs for functional validation, of which hsa-miR-155-5p and hsa-miR-532-5p were significantly associated with changes in dexamethasone-induced transrepression of NF-κB. Combined, these two miRNAs were predictive of ICS response over the course of the clinical trial, with an area under the receiver operating characteristic curve of 0.86. Conclusions:  We identified two functional circulating miRNAs predictive of asthma ICS treatment response over time.",2020,We identified 7 miRNAs significantly associated with FEV1% change (p<=0.05) and 15 miRNAs with significant interaction (p<=0.05) to ICS versus placebo treatments.,"['Childhood Asthma', '462 CAMP subjects subsequently randomized to either']","['corticosteroids (ICS', 'placebo', 'ICS (budesonide) or placebo']",['ICS response'],"[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",462.0,0.187332,We identified 7 miRNAs significantly associated with FEV1% change (p<=0.05) and 15 miRNAs with significant interaction (p<=0.05) to ICS versus placebo treatments.,"[{'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Panganiban', 'Affiliation': 'Program in Molecular and Integrative Physiological Sciences, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; and.'}, {'ForeName': 'Alvin T', 'Initials': 'AT', 'LastName': 'Kho', 'Affiliation': ""Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'McGeachie', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Leanna', 'Initials': 'L', 'LastName': 'Farnam', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Chase', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Program in Molecular and Integrative Physiological Sciences, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; and.'}, {'ForeName': 'Kelan G', 'Initials': 'KG', 'LastName': 'Tantisira', 'Affiliation': 'Channing Division of Network Medicine and.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201907-1454OC']
356,32199926,A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair.,"BACKGROUND


Given the accelerating opioid crisis in the United States and evidence that patients use fewer opioid tablets than prescribed, surgeons may choose to decrease prescribed quantities. The effect this may have on patient satisfaction with pain control after hospital discharge is unknown.
OBJECTIVE


The primary objective of this study was to compare patient satisfaction with postoperative pain control between patients receiving a routine or reduced quantity opioid prescription after prolapse repair. Secondary objectives included a comparison of opioid-related side-effects, the number of opioid tablets used, and the number of excess tablets prescribed between these groups.
STUDY DESIGN


This was a single-center, unmasked, 2-arm, randomized controlled noninferiority trial of women who underwent a prolapse repair with a planned overnight hospitalization. Patients were assigned randomly to 1 of 2 study arms: routine (28 tablets of oxycodone 5 mg) or reduced (5 tablets) prescription of opioid tablets. Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay. Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of ≥30 on the Pain Catastrophizing Scale. In addition to their opioid prescription, all patients received multimodal pain medications at discharge. Patients were asked to complete 6 weeks of diaries to record pain and medication use. The primary outcome (patient satisfaction) was collected as part of a postoperative survey completed at patients' routine postoperative visit 6 weeks after surgery. The sample size for noninferiority was calculated at 59 patients per group for a total of 118 patients.
RESULTS


One hundred eighteen patients were assigned randomly; the primary outcome was available for 116. The majority of patients were white, postmenopausal, and nonsmokers; the mean age was 62±10.4 years. The most common surgery was a hysterectomy with native tissue repair (n=71; 60%). One hundred ten patients (93%) were satisfied with postoperative pain control. Statistical analysis constructed for noninferiority showed that the difference between the groups was <15% (93% vs 93%; P=.005). Subjects in the reduced arm reported requiring an additional opioid prescription more frequently than in the routine arm (15% vs 2%; P=.01). Patients in the routine arm used more opioid tablets than the reduced arm (median, 3 [interquartile range, 0-14] vs 1 [interquartile range, 0-3]), but overall opioid utilization was low. As such, patients in the routine arm had significantly more unused opioid tablets (median, 26 [interquartile range, 15-28] vs 4 [interquartile range, 2-5]).
CONCLUSION


Patient satisfaction with pain control was noninferior in patients who received a reduced quantity of opioid tablets after prolapse repair compared with those who received a routine prescription. A large quantity of excess opioid tablets was seen in both groups. Surgeons should consider prescribing 5-10 opioid tablets after prolapse repair surgery and consider applying these findings to postoperative prescribing after other gynecologic procedures.",2020,Patients in the routine arm used more opioid tablets than the reduced arm (median 3 [IQR 0-14] vs 1 [IQR 0-3]) but overall opioid utilization was low.,"['after Prolapse Repair', 'Patients were eligible if they were at least 18 years of age and undergoing a prolapse repair with an anticipated overnight hospital stay', 'Exclusion criteria included a history of chronic pain, preoperative opioid use, intolerance to study medication, or a score of 30 or greater on the Pain Catastrophizing Scale', 'women undergoing a prolapse repair with a planned overnight hospitalization', 'patients receiving a routine or reduced quantity opioid prescription after prolapse repair', '118 patients']","['hysterectomy with native tissue repair', 'Reduced Versus Routine Opioid Prescription', 'multimodal pain medications', 'routine (28 tablets of oxycodone 5mg) or reduced (5 tablets) prescription of opioid tablets']","['opioid tablets', 'requiring an additional opioid prescription', 'comparison of opioid-related side effects, number of opioid tablets used, and the number of excess tablets prescribed between these groups', 'patient satisfaction with postoperative pain control', 'unused opioid', 'postoperative pain control', 'overall opioid utilization']","[{'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042153', 'cui_str': 'use'}]",118.0,0.391597,Patients in the routine arm used more opioid tablets than the reduced arm (median 3 [IQR 0-14] vs 1 [IQR 0-3]) but overall opioid utilization was low.,"[{'ForeName': 'Emily R W', 'Initials': 'ERW', 'LastName': 'Davidson', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH. Electronic address: edavidson@mcw.edu.""}, {'ForeName': 'Marie Fidela R', 'Initials': 'MFR', 'LastName': 'Paraiso', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.""}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Walters', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Propst', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.""}, {'ForeName': 'Beri', 'Initials': 'B', 'LastName': 'Ridgeway', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Cecile A', 'Initials': 'CA', 'LastName': 'Ferrando', 'Affiliation': ""Center for Urogynecology & Pelvic Reconstructive Surgery, Obstetrics, Gynecology & Women's Health Institute, Cleveland Clinic, Cleveland, OH.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.03.017']
357,32200425,Effectiveness of the use of an algorithm in the diagnostic approach of joint pain patients by primary care physicians.,"There is a high percentage of error in the approach of patients with joint pain by primary care physicians. An algorithm can help improve this misdiagnosis problem. Our study seeks to determine the effectiveness of an algorithm when used by primary care physicians for the diagnosis of cases of joint pain patients. A randomized clinical experiment was carried out. Primary care physicians from five cities in Colombia developed a series of clinical cases, which were presented to them through a website on their personal cell phones. Half of the doctors developed the cases using the diagnostic algorithm, and the other half developed the cases without the use of the algorithm. Main measures were proportion of correct diagnosis, number, type of laboratory and diagnostic images requested for the diagnostic approach of clinical cases. Two hundred and twenty-four primary care physicians participated. The overall proportion of cases correctly diagnosed was 37.3% higher in the intervention group; we found a greater difference in cases of spondyloarthritis (60.8%), followed by systemic lupus erythematosus with joint involvement (32.2%), rheumatoid arthritis (30.3%) and osteoarthritis (25.9%). The average number of tests requested to develop clinical cases was lower in the intervention group than in the control group, both globally and for each of the four diseases, with statistically significant differences for each of the comparisons. The diagnostic algorithm proved to be an effective tool when used by primary care physicians; the proportion of correct diagnoses increased, and the number of tests requested in the development of the cases decreased.",2020,"The diagnostic algorithm proved to be an effective tool when used by primary care physicians; the proportion of correct diagnoses increased, and the number of tests requested in the development of the cases decreased.","['Primary care physicians from five cities in Colombia developed a series of clinical cases, which were presented to them through a website on their personal cell phones', 'Two hundred and twenty-four primary care physicians participated', 'joint pain patients by primary care physicians', 'patients with joint pain by primary care physicians', 'primary care physicians for the diagnosis of cases of joint pain patients']",[],"['average number of tests requested to develop clinical cases', 'systemic lupus erythematosus with joint involvement', 'rheumatoid arthritis', 'proportion of correct diagnosis, number, type of laboratory and diagnostic images requested for the diagnostic approach of clinical cases']","[{'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1136359', 'cui_str': 'Cell Phone'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1273874', 'cui_str': 'Test request'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0686900', 'cui_str': 'Request for (contextual qualifier) (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",,0.0216508,"The diagnostic algorithm proved to be an effective tool when used by primary care physicians; the proportion of correct diagnoses increased, and the number of tests requested in the development of the cases decreased.","[{'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Fernández-Ávila', 'Affiliation': 'PhD Program in Clinical Epidemiology, Department of Clinical Epidemiology and Biostatistics, School of Medicine, Pontificia Universidad Javeriana-Hospital Universitario San Ignacio, Bogotá, Colombia. daniel.fernandez@javeriana.edu.co.'}, {'ForeName': 'M X', 'Initials': 'MX', 'LastName': 'Rojas', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, School of Medicine, Pontificia Universidad Javeriana, Bogotá, Colombia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ramírez', 'Affiliation': 'Rheumatoid Arthritis Program, Sánitas EPS, Bogotá, Colombia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rodelo', 'Affiliation': 'Javesalud IPS, Bogotá, Colombia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Soriano', 'Affiliation': 'Rheumatology Section, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}]",Rheumatology international,['10.1007/s00296-020-04552-1']
358,32210365,Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial.,"BACKGROUND


The cancer vaccine Vx-001, which targets the universal tumour antigen TElomerase Reverse Transcriptase (TERT), can mount specific Vx-001/TERT 572  CD8 + cytotoxic T cells; this immune response is associated with improved overall survival (OS) in patients with advanced/metastatic non-small cell lung cancer (NSCLC).
METHODS


A randomised, double blind, phase 2b trial, in HLA-A*201-positive patients with metastatic, TERT-expressing NSCLC, who did not progress after first-line platinum-based chemotherapy were randomised to receive either Vx-001 or placebo. The primary endpoint of the trial was OS.
RESULTS


Two hundred and twenty-one patients were randomised and 190 (101 and 89 patients in the placebo and the Vx-001 arm, respectively) were analysed for efficacy. There was not treatment-related toxicity >grade 2. The study did not meet its primary endpoint (median OS 11.3 and 14.3 months for the placebo and the Vx-001, respectively; p = 0.86) whereas the median Time to Treatment Failure (TTF) was 3.5 and 3.6 months, respectively. Disease control for >6months was observed in 30 (33.7%) and 26 (25.7%) patients treated with Vx-001 and placebo, respectively. There was no documented objective CR or PR. Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
CONCLUSION


Vx-001 could induce specific CD8 +  immune response but failed to meet its primary endpoint. Subsequent studies have to be focused on the identification and treatment of subgroups of patients able to mount an effective immunological response to Vx-001.
CLINICAL TRIAL REGISTRATION


NCT01935154.",2020,"Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
","['patients with advanced/metastatic non-small cell lung cancer (NSCLC', 'patients with stage IV non-small cell lung cancer', 'Two hundred and twenty-one patients were randomised and 190 (101 and 89 patients in the', 'A*201-positive patients with metastatic, TERT-expressing NSCLC, who did not progress after first-line platinum-based chemotherapy']","['htert (vx-001) cancer vaccine', 'HLA', 'placebo', 'Vx-001 or placebo', 'chemotherapy maintenance immunotherapy']","['objective CR or PR', 'overall survival (OS', 'median Time to Treatment Failure (TTF', 'specific CD8 +  immune response', 'Long lasting TERT-specific immune response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1958472', 'cui_str': 'Vx001 cpd'}, {'cui': 'C0376659', 'cui_str': 'Vaccines, Tumor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",221.0,0.621622,"Long lasting TERT-specific immune response was observed in 29.2% of vaccinated patients who experienced a significantly longer OS compared to non-responders (21.3 and 13.4 months, respectively; p = 0.004).
","[{'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Gridelli', 'Affiliation': 'S.G. Moscati Hospital, Avellino, Italy. cgridelli@libero.it.'}, {'ForeName': 'Tudor', 'Initials': 'T', 'LastName': 'Ciuleanu', 'Affiliation': 'Institutui, Oncologic I. Chircuta, Cluz-Napoca, Romania.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': 'Fundacion Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Szczesna', 'Affiliation': 'Mazowieckie Centrum, Otwock, Poland.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Bover', 'Affiliation': 'Son Llatzer Hospital, Palma de Mallorca, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Hospital Regional Universitario Málaga, Instituto de Investigaciones Biomédicas (IBIMA), Málaga, Spain.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Kentepozidis', 'Affiliation': '251 General Airforce Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Zarogoulidis', 'Affiliation': 'Papanikolaou General Hospital, Exohi, Greece.'}, {'ForeName': 'Charalabos', 'Initials': 'C', 'LastName': 'Kalofonos', 'Affiliation': 'University Hospital of Patras, Rio, Greece.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kazarnowisz', 'Affiliation': 'Oddzial Onkologiiz Pododdziatem, Olsztyn, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Korozan', 'Affiliation': 'Hospicjum Dutkiewicza SAC, Gdansk, Poland.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'de Las Penas', 'Affiliation': 'Hospital Provincial de Castellon, Castellon, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creui Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Chella', 'Affiliation': 'A.O.U. di Pisa Hospital, Pisa, Italy.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Griesinger', 'Affiliation': 'Pius Hospital, Oldenburg, Germany.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Bournakis', 'Affiliation': 'University Hospital ""Aretaieion"", Athens, Greece.'}, {'ForeName': 'Parvis', 'Initials': 'P', 'LastName': 'Sadjadian', 'Affiliation': 'Johannes Wesling Klinikum, Minden, Germany.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Kotsakis', 'Affiliation': 'Dpt of Medical Oncology, University General Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Chinet', 'Affiliation': 'Hopital Ambroise Paré, Boulogne-Billancourt, France.'}, {'ForeName': 'Kostantinos N', 'Initials': 'KN', 'LastName': 'Syrigos', 'Affiliation': 'General Hospital of Thoracic Diseases \'\'Sotiria"", Athens, Greece.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Correale', 'Affiliation': 'University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gallou', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Jeanne- Menez', 'Initials': 'JM', 'LastName': 'Jamet', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Eleni- Kyriaki', 'Initials': 'EK', 'LastName': 'Vetsika', 'Affiliation': 'University General Hospital of Heraklion, Heraklion, Crete, Greece.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Kosmatopoulos', 'Affiliation': 'Vaxon-Biotech, Paris, France.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Georgoulias', 'Affiliation': 'University General Hospital of Heraklion, Heraklion, Crete, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of cancer,['10.1038/s41416-020-0785-y']
359,30239596,Aesthetic Treatment Positively Impacts Social Perception: Analysis of Subjects From the HARMONY Study.,"BACKGROUND


The impact of facial aesthetic treatments not only enhances physical appearance but also psychological well-being. Accordingly, patient-reported outcomes are increasingly utilized as an important measure of treatment success. Observer-reported outcomes are a relevant yet often overlooked measure of treatment benefit.
OBJECTIVES


The authors aimed to evaluate the impact of panfacial aesthetic treatment on the perception of an individual in a variety of social contexts.
METHODS


A total 2000 men and women (aged 18-65 years) participated in an online study designed to capture the blinded observer's social perception of pretreatment and posttreatment patients who received panfacial aesthetic treatment in the HARMONY study. Perceptions relevant to character traits, age, attractiveness, and social status were evaluated. Observers were divided into 2 groups. Single image respondents (n = 1500) viewed 6 single, randomized patient images (3 pretreatment, 3 posttreatment), and paired image respondents (n = 500) viewed 6 pretreatment and posttreatment image pairs.
RESULTS


Single image respondents reported significantly (P < 0.05) higher levels of agreement that posttreatment subjects appeared to possess more positive character traits (eg, healthy and approachable), were more socially adept, younger, more attractive, more successful at attracting others, and possessed a higher social status. Paired image respondents also reported a higher level of agreement for posttreatment images being aligned with positive character traits, representative of a younger and more attractive individual, and one with a higher social status.
CONCLUSIONS


The results suggest that the positive impact of minimally invasive panfacial treatment extends beyond enhancing physical appearance and highlights the importance of social perception and observer-reported outcomes in aesthetic medicine.",2019,"Results


Single Image Respondents reported significantly (P <0.05) higher levels of agreement that posttreatment subjects appeared to possess more positive character traits (eg, healthy and approachable), were more socially adept, younger, more attractive, more successful at attracting others, and possessed a higher social status.","['Subjects From the HARMONY Study', '2000 men and women (aged 18-65 years']",['panfacial aesthetic treatment'],[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0257234,"Results


Single Image Respondents reported significantly (P <0.05) higher levels of agreement that posttreatment subjects appeared to possess more positive character traits (eg, healthy and approachable), were more socially adept, younger, more attractive, more successful at attracting others, and possessed a higher social status.","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Dayan', 'Affiliation': 'Department of Otolaryngology, University of Illinois, Chicago, IL.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rivkin', 'Affiliation': 'David Geffen/UCLA School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Sykes', 'Affiliation': 'Facial Plastic and Reconstructive Surgery, UC Davis Medical Group, Sacramento, CA.'}, {'ForeName': 'Craig F', 'Initials': 'CF', 'LastName': 'Teller', 'Affiliation': ''}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Weinkle', 'Affiliation': 'Affiliate Clinical Professor of Dermatology, University of South Florida, Tampa, FL.'}, {'ForeName': 'Garrett T', 'Initials': 'GT', 'LastName': 'Shumate', 'Affiliation': ''}, {'ForeName': 'Conor J', 'Initials': 'CJ', 'LastName': 'Gallagher', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjy239']
360,31749028,"Impact of a Low-Intensity Resource Referral Intervention on Patients' Knowledge, Beliefs, and Use of Community Resources: Results from the CommunityRx Trial.","BACKGROUND


Connecting patients to community-based resources is now a cornerstone of modern healthcare that supports self-management of health. The mechanisms that link resource information to behavior change, however, remain poorly understood.
OBJECTIVE


To evaluate the impact of CommunityRx, an automated, low-intensity resource referral intervention, on patients' knowledge, beliefs, and use of community resources.
DESIGN


Real-world controlled clinical trial at an urban academic medical center in 2015-2016; participants were assigned by alternating week to receive the CommunityRx intervention or usual care. Surveys were administered at baseline, 1 week, 1 month, and 3 months.
PARTICIPANTS


Publicly insured adults, ages 45-74 years.
INTERVENTION


CommunityRx generated an automated, personalized list of resources, known as HealtheRx, near each participant's home using condition-specific, evidence-based algorithms. Algorithms used patient demographic and health characteristics documented in the electronic health record to identify relevant resources from a comprehensive, regularly updated database of health-related resources in the study area.
MAIN MEASURES


Using intent-to-treat analysis, we examined the impact of HealtheRx referrals on (1) knowledge of the most commonly referred resource types, including healthy eating classes, individual counseling, mortgage assistance, smoking cessation, stress management, and weight loss classes or groups, and (2) beliefs about having resources in the community to manage health.
KEY RESULTS


In a real-world controlled trial of 374 adults, intervention recipients improved knowledge (AOR = 2.15; 95% CI, 1.29-3.58) and beliefs (AOR = 1.68; 95% CI, 1.07-2.64) about common resources in the community to manage health, specifically gaining knowledge about smoking cessation (AOR = 2.76; 95% CI, 1.07-7.12) and weight loss resources (AOR = 2.26; 95% CI 1.05-4.84). Positive changes in both knowledge and beliefs about community resources were associated with higher resource use (P = 0.02).
CONCLUSIONS


In a middle-age and older population with high morbidity, a low-intensity health IT intervention to deliver resource referrals promoted behavior change by increasing knowledge and positive beliefs about community resources for self-management of health.
NIH TRIAL REGISTRY


NCT02435511.",2020,"Positive changes in both knowledge and beliefs about community resources were associated with higher resource use (P = 0.02).
","['urban academic medical center in 2015-2016; participants', 'Publicly insured adults, ages 45-74\xa0years', 'healthy eating classes, individual counseling, mortgage assistance, smoking cessation, stress management, and weight loss classes or groups, and (2)\xa0beliefs about having resources in the community to manage health', '374 adults']","['Low-Intensity Resource Referral Intervention', 'CommunityRx intervention or usual care']","['knowledge', 'weight loss resources']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",374.0,0.0757793,"Positive changes in both knowledge and beliefs about community resources were associated with higher resource use (P = 0.02).
","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Tung', 'Affiliation': 'Section of General Internal Medicine, University of Chicago, Chicago, IL, USA. eliztung@uchicago.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Abramsohn', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Boyd', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Makelarski', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Beiser', 'Affiliation': 'Section of Emergency Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Chiahung', 'Initials': 'C', 'LastName': 'Chou', 'Affiliation': 'Department of Health Outcomes Research and Policy, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Elbert S', 'Initials': 'ES', 'LastName': 'Huang', 'Affiliation': 'Section of General Internal Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ozik', 'Affiliation': 'Consortium for Advanced Science and Engineering, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Chaitanya', 'Initials': 'C', 'LastName': 'Kaligotla', 'Affiliation': 'Consortium for Advanced Science and Engineering, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Stacy Tessler', 'Initials': 'ST', 'LastName': 'Lindau', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05530-5']
361,32203207,Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial.,"BACKGROUND


Cardiotoxicity is the most significant adverse event associated with trastuzumab (T), the main component of HER2-positive breast cancer (BC) treatment. Less is known about the cardiotoxicity of dual HER2 blockade with T plus lapatinib (L), although this regimen is used in the metastatic setting.
METHODS


This is a sub-analysis of the ALTTO trial comparing adjuvant treatment options for patients with early HER2-positive BC. Patients randomised to either T or concomitant T + L were eligible. Cardiac events (CEs) rates were compared according to treatment arm.
RESULTS


With 6.9 years of median follow-up (FU) and 4190 patients, CE were observed in 363 (8.6%): 166 (7.9%) of patient in T + L arm vs. 197 (9.3%) in T arm (OR = 0.85 [95% CI, 0.68-1.05]). During anti-HER2 treatment 270 CE (6.4%) occurred while 93 (2.2%) were during FU (median time to onset = 6.6 months [IQR = 3.4-11.7]). While 265 CEs were asymptomatic (73%), 94 were symptomatic (26%) and four were cardiac deaths (1%). Recovery was observed in 301 cases (83.8%). Identified cardiac risk factors were: baseline LVEF < 55% (vs > 64%, OR 3.1 [95% CI 1.54-6.25]), diabetes mellitus (OR 1.85 [95% CI 1.25-2.75]), BMI > 30 kg/m 2  (vs < 25 mg/kg 2 , OR 2.21 [95% CI 1.40-3.49]), cumulative dose of doxorubicin ≥240 mg/m 2  (OR 1.36 [95% CI 1.01-1.82]) and of epirubicin≥ 480 mg/m 2  (OR 2.33 [95% CI 1.55-3.51]).
CONCLUSIONS


Dual HER2 blockade with T + L is a safe regimen from a cardiac perspective, but cardiac-focused history for proper patient selection is crucial.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Identifier: NCT00490139 (registration date: 22/06/2007); EudraCT Number: 2006-000562-36 (registration date: 04/05/2007); Sponsor Protocol Number: BIG2-06 /EGF106708/N063D.",2020,"Cardiac events (CEs) rates were compared according to treatment arm.
","['patients with early HER2-positive BC', 'patients with HER2-positive breast cancer treated in the']","['trastuzumab (T', 'adjuvant lapatinib', 'T or concomitant T\u2009+\u2009L', 'doxorubicin']","['diabetes mellitus', 'Cardiac events (CEs) rates', 'Recovery', 'cardiac deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}]",,0.264623,"Cardiac events (CEs) rates were compared according to treatment arm.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eiger', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Noam F', 'Initials': 'NF', 'LastName': 'Pondé', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Agbor-Tarh', 'Affiliation': 'Frontier Science, Kingussie, United Kingdom.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.""}, {'ForeName': 'Florentine S', 'Initials': 'FS', 'LastName': 'Hilbers', 'Affiliation': 'Breast International Group (BIG), Brussels, Belgium.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Werner', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Chumsri', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Amylou', 'Initials': 'A', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Gomez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Láng', 'Affiliation': 'Istenhegyi Géndiagnosztika Private Health Center, Oncology Clinic, Budapest, Hungary.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Rodeheffer', 'Affiliation': 'Cardiovascular Department, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ewer', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Suter', 'Affiliation': 'Department of Cardiology, lnselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': ""Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium. evandro.azambuja@bordet.be.""}]",British journal of cancer,['10.1038/s41416-020-0786-x']
362,32402553,"Visual Field Outcomes from the Multicenter, Randomized Controlled Laser in Glaucoma and Ocular Hypertension Trial (LiGHT).","PURPOSE


To compare visual field outcomes of ocular hypertensive and glaucoma patients treated first with medical therapy with those treated first with selective laser trabeculoplasty (SLT).
DESIGN


Secondary analysis of patients from the Laser in Glaucoma and Ocular Hypertension study, a multicenter randomized controlled trial.
PARTICIPANTS


Three hundred forty-four patients (588 eyes) treated first with medical therapy and 344 patients (590 eyes) treated first with SLT.
METHODS


Visual fields (VFs) were measured using standard automated perimetry and arranged in series (median length and duration, 9 VFs over 48 months). Hierarchical linear models were used to estimate pointwise VF progression rates, which were then averaged to produce a global progression estimate for each eye. Proportions of points and patients in each treatment group with fast (<-1 dB/year) or moderate (<-0.5 dB/year) progression were compared using log-binomial regression.
MAIN OUTCOME MEASURES


Pointwise and global progression rates of total deviation (TD) and pattern deviation (PD).
RESULTS


A greater proportion of eyes underwent moderate or fast TD progression in the medical therapy group compared with the SLT group (26.2% vs. 16.9%; risk ratio [RR], 1.55; 95% confidence interval [CI], 1.23-1.93; P < 0.001). A similar pattern was observed for pointwise rates (medical therapy, 26.1% vs. SLT, 19.0%; RR, 1.37; 95% CI, 1.33-1.42; P < 0.001). A greater proportion of pointwise PD rates were categorized as moderate or fast in the medical therapy group (medical therapy, 11.5% vs. SLT, 8.3%; RR, 1.39; 95% CI, 1.32-1.46; P < 0.001). No statistical difference was found in the proportion of eyes that underwent moderate or fast PD progression (medical therapy, 9.9% vs. SLT, 7.1%; RR, 1.39; 95% CI, 0.95, 2.03; P = 0.0928).
CONCLUSIONS


A slightly larger proportion of ocular hypertensive and glaucoma patients treated first with medical therapy underwent rapid VF progression compared with those treated first with SLT.",2020,"No statistical difference was found in the proportion of eyes that underwent moderate or fast PD progression (medical therapy, 9.9% vs. SLT, 7.1%; RR, 1.39; 95% CI, 0.95, 2.03; P = 0.0928).
","['patients from the Laser in Glaucoma and Ocular Hypertension study', 'Three hundred forty-four patients (588 eyes) treated first with medical therapy and 344 patients (590 eyes) treated first with', 'ocular hypertensive and glaucoma patients treated first with']","['medical therapy', 'SLT', 'selective laser trabeculoplasty (SLT']","['pointwise rates', 'fast TD progression', 'proportion of eyes that underwent moderate or fast PD progression', 'pointwise PD rates', 'Pointwise and global progression rates of total deviation (TD) and pattern deviation (PD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851409', 'cui_str': 'Glaucoma and ocular hypertension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C5191356', 'cui_str': '590'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}]","[{'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C1271447', 'cui_str': 'Selective laser trabeculoplasty'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0639216,"No statistical difference was found in the proportion of eyes that underwent moderate or fast PD progression (medical therapy, 9.9% vs. SLT, 7.1%; RR, 1.39; 95% CI, 0.95, 2.03; P = 0.0928).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Wright', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom; Health Data Research UK, London, United Kingdom.""}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Konstantakopoulou', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Institute of Ophthalmology, University College London, United Kingdom; Division of Optics and Optometry, University of West Attica, Athens, Greece.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Montesano', 'Affiliation': 'Optometry and Visual Science, School of Health Science, City, University of London, London, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Nathwani', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garway-Heath', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Institute of Ophthalmology, University College London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Crabb', 'Affiliation': 'Optometry and Visual Science, School of Health Science, City, University of London, London, United Kingdom. Electronic address: David.Crabb1@city.ac.uk.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Gazzard', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Institute of Ophthalmology, University College London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.029']
363,32402555,Spectral-Domain OCT Analysis of Risk Factors for Macular Atrophy Development in the HARBOR Study for Neovascular Age-Related Macular Degeneration.,"PURPOSE


To identify baseline risk factors for macular atrophy (MA) development in HARBOR via a longitudinal assessment of monthly spectral-domain (SD)-OCT scans. Previous analyses of MA in HARBOR examined data from color fundus photography (CFP) and fluorescein angiography (FA).
DESIGN


Retrospective, post hoc analysis of SD-OCT images from HARBOR (ClinicalTrials.gov identifier, NCT00891735), a phase 3, multicenter, prospective, randomized, double-blind, active treatment-controlled clinical trial.
PARTICIPANTS


Patients (N = 1097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) treated with intravitreal ranibizumab 0.5 mg monthly (n = 275), 0.5 mg pro re nata (PRN) after 3 loading doses (n = 275), 2.0 mg monthly (n = 274), or 2.0 mg PRN (n = 273).
METHODS


Evaluable SD-OCT macular cube scans from patients with 24 months of follow-up (N = 941) were examined monthly from baseline to month 24 by masked reading center-trained graders. Atrophy diagnosis criteria were consistent with those proposed by the Classification of Atrophy Meetings (CAM) group: hypertransmission of light into the choroid, loss of retinal pigment epithelium, and loss of outer retinal layers. Multivariable proportional hazards regression was performed for time to atrophy development.
MAIN OUTCOME MEASURES


Risk factors for MA as determined by time to MA development over 24 months of treatment.
RESULTS


Baseline risk factors for MA were confirmed from prior analyses that used CFP and FA data: absence of subretinal fluid, presence of intraretinal cysts, presence of Type 3 neovascularization, and presence of atrophy in the fellow eye. This analysis of SD-OCT data identified new baseline risk factors for MA: higher central drusen volume, lower choroidal thickness, presence of nascent atrophy, presence of reticular pseudodrusen, and increased central foveal thickness. Ranibizumab treatment regimen and dose level were not found to be risk factors for MA development.
CONCLUSIONS


In this analysis of a major nAMD trial using CAM atrophy criteria, new baseline risk factors for MA development were identified using an SD-OCT dataset. Risk factors for MA development identified by prior analyses were confirmed. Monthly treatment with ranibizumab 0.5 mg was not found to be a risk factor for MA development over 24 months.",2020,Monthly treatment with ranibizumab 0.5 mg was not found to be a risk factor for MA development over 24 months.,"['Evaluable SD-OCT macular cube scans from patients with 24 months of follow-up', 'Patients (N\xa0= 1097) with subfoveal choroidal neovascularization secondary to neovascular age-related macular degeneration (nAMD) treated with']","['Ranibizumab', 'intravitreal ranibizumab 0.5 mg monthly (n\xa0= 275), 0.5 mg pro re nata (PRN', 'ranibizumab']",['central foveal thickness'],"[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",1097.0,0.0829013,Monthly treatment with ranibizumab 0.5 mg was not found to be a risk factor for MA development over 24 months.,"[{'ForeName': 'SriniVas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California. Electronic address: ssadda@doheny.org.'}, {'ForeName': 'Nizar Saleh', 'Initials': 'NS', 'LastName': 'Abdelfattah', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': ""Doheny Eye Institute, Los Angeles, California; Department of Ophthalmology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Marion', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Morgenthien', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Shamika', 'Initials': 'S', 'LastName': 'Gune', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Balasubramanian', 'Affiliation': 'Doheny Eye Institute, Los Angeles, California.'}]",Ophthalmology,['10.1016/j.ophtha.2020.03.031']
364,32200759,Derivation and Application of a Tool to Estimate Benefits From Multiple Therapies That Reduce Recurrent Stroke Risk.,"Background and Purpose- Lowering blood pressure and cholesterol, antiplatelet/antithrombotic use, and smoking cessation reduce risk of recurrent stroke. However, gaps in risk factor control among stroke survivors warrant development and evaluation of alternative care delivery models that aim to simultaneously improve multiple risk factors. Randomized trials of care delivery models are rarely of sufficient duration or size to be powered for low-frequency outcomes such as observed recurrent stroke. This creates a need for tools to estimate how changes across multiple stroke risk factors reduce risk of recurrent stroke. Methods- We reviewed existing evidence of the efficacy of interventions addressing blood pressure reduction, cholesterol lowering, antiplatelet/antithrombotic use, and smoking cessation and extracted relative risks for each intervention. From this, we developed a tool to estimate reductions in recurrent stroke risk, using bootstrapping and simulation methods. We also calculated a modified Global Outcome Score representing the proportion of potential benefit (relative risk reduction) achieved if all 4 individual risk factors were optimally controlled. We applied the tool to estimate stroke risk reduction among 275 participants with complete 12-month follow-up data from a recently published randomized trial of a healthcare delivery model that targeted multiple stroke risk factors. Results- The recurrent stroke risk tool was feasible to apply, yielding an estimated reduction in the relative risk of ischemic stroke of 0.36 in both the experimental and usual care trial arms. Global Outcome Score results suggest that participants in both arms likely averted, on average, 45% of recurrent stroke events that could possibly have been prevented through maximal implementation of interventions for all 4 individual risk factors. Conclusions- A stroke risk reduction tool facilitates estimation of the combined impact on vascular risk of improvements in multiple stroke risk factors and provides a summary outcome for studies testing alternative care models to prevent recurrent stroke. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00861081.",2020,"Global Outcome Score results suggest that participants in both arms likely averted, on average, 45% of recurrent stroke events that could possibly have been prevented through maximal implementation of interventions for all 4 individual risk factors.",['275 participants with complete 12-month follow-up data from a recently published randomized trial of a healthcare delivery model that targeted multiple stroke risk factors'],"['Conclusions', ' and Purpose', 'Methods']","['Lowering blood pressure and cholesterol, antiplatelet/antithrombotic use, and smoking cessation reduce risk of recurrent stroke', 'Recurrent Stroke Risk']","[{'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0011211', 'cui_str': 'Delivery of Healthcare'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}]",275.0,0.076074,"Global Outcome Score results suggest that participants in both arms likely averted, on average, 45% of recurrent stroke events that could possibly have been prevented through maximal implementation of interventions for all 4 individual risk factors.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Richards', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Jackson', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Bryg', 'Affiliation': 'Olive View-UCLA Medical Center, Sylmar, CA (R.J.B., A.B.).'}, {'ForeName': 'Arleen', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Amytis', 'Initials': 'A', 'LastName': 'Towfighi', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA (A.T.).'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Sanossian', 'Affiliation': 'Keck School of Medicine of USC, Los Angeles, CA (N.S.).'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY (B.G.V.).'}]",Stroke,['10.1161/STROKEAHA.119.027160']
365,32197805,"Effectiveness of video-based rehabilitation program on pain, functionality, and quality of life in the treatment of rotator cuff tears: A randomized controlled trial.","BACKGROUND


Video-based rehabilitation programs, which are also used in the treatment of neurological disorders, could be a beneficial treatment option for patients who cannot receive treatment.
PURPOSE


To determine the efficacy of video-based rehabilitation program in the conservative treatment of partial rotator cuff tears in comparison to a physiotherapist-supervised rehabilitation program.
STUDY DESIGN


A randomized controlled clinical trial.
METHODS


Thirty-three voluntary patients with partial rotator cuff tear were randomized into two groups: video-based rehabilitation (VBR) group and physiotherapist-supervised rehabilitation (PSR) group, for a common 6 weeks rehabilitation program. After drop outs, thirty participants (mean ± SD age, 50.60 ± 8.54 years; 10 female) were finally completed the trial. Active shoulder range of motion, pain, functional status, and health-related quality of life of the patients were assessed before and after treatment. Also, treatment satisfaction level was assessed at the end of the treatment.
RESULTS


There was statistically significant improvement in terms of active shoulder range of motion values (mean differences at 95% confidence interval for abduction: 30.75-51.37 in the VBR group, 34.20-54.45 in the PSR group, P = .001 in both groups) and secondary outcome measures within both groups (P < .05). However, there were no statistically significant differences in terms of all outcome measures between groups (P > .05). The level of satisfaction from treatment in the PSR group was higher than that in the VBR group.
CONCLUSION


A video-based rehabilitation program is an effective option in terms of shoulder range of motion, pain, functionality, and quality of life and has a comparable success level with a PSR program in the conservative treatment of partial rotator cuff tears.",2020,"There was statistically significant improvement in terms of active shoulder range of motion values (mean differences at 95% confidence interval for abduction: 30.75-51.37 in the VBR group, 34.20-54.45 in the PSR group, P = .001 in both groups) and secondary outcome measures within both groups (P < .05).","['partial rotator cuff tears', 'thirty participants (mean ± SD age, 50.60 ± 8.54 years; 10 female', 'rotator cuff tears', 'partial rotator cuff tears in comparison to a physiotherapist-supervised rehabilitation program', 'Thirty-three voluntary patients with partial rotator cuff tear', 'patients who cannot receive treatment']","['video-based rehabilitation program', 'video-based rehabilitation (VBR) group and physiotherapist-supervised rehabilitation (PSR) group, for a common 6 weeks rehabilitation program']","['active shoulder range of motion values', 'treatment satisfaction level', 'Active shoulder range of motion, pain, functional status, and health-related quality of life', 'pain, functionality, and quality of life', 'level of satisfaction']","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0580276', 'cui_str': 'Informal patient (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0575545', 'cui_str': 'Joint movement: shoulder'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",33.0,0.0696901,"There was statistically significant improvement in terms of active shoulder range of motion values (mean differences at 95% confidence interval for abduction: 30.75-51.37 in the VBR group, 34.20-54.45 in the PSR group, P = .001 in both groups) and secondary outcome measures within both groups (P < .05).","[{'ForeName': 'Ezgi', 'Initials': 'E', 'LastName': 'Türkmen', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Istanbul University-Cerrahpasa, Institute of Graduate Education, Istanbul, Turkey. Electronic address: ezgi.turkmen.49@hotmail.com.'}, {'ForeName': 'Yıldız', 'Initials': 'Y', 'LastName': 'Analay Akbaba', 'Affiliation': 'Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Süleyman', 'Initials': 'S', 'LastName': 'Altun', 'Affiliation': 'Department of Orthopaedics and Traumatology, Bakırkoy Dr. Sadi Konuk Education and Research Hospital, Istanbul, Turkey.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.08.004']
366,32205226,Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma.,"BACKGROUND & AIMS


Patients with hepatocellular carcinoma (HCC) secondary to chronic liver disease often require invasive procedures but frequently have thrombocytopenia. Lusutrombopag is an agonist of the thrombopoietin receptor that activates platelet production.
METHODS


We performed an integrated analysis of data from 2 phase 3 trials (L-PLUS 1, Japan, October 2013 to May 2014, and L-PLUS 2, global, June 2015 to April 2017) that compared the efficacy and safety of lusutrombopag with placebo in patients with chronic liver disease, with and without HCC. Our analysis included patients with Eastern Cooperative Oncology Group grades of 0 or 1, Child-Pugh classes A or B, and a platelet count less than 50 × 10 9 /L who were scheduled to undergo invasive procedures in 9 to 14 days. Patients received lusutrombopag (3 mg) or placebo daily for 7 days or fewer before an invasive procedure. Imaging studies assessed treatment-emergent adverse events, including asymptomatic portal vein thrombosis. The primary end point was no requirement for platelet transfusion before the invasive procedure and rescue therapies for bleeding 7 days or fewer after the invasive procedure.
RESULTS


The per-protocol population included 270 patients (95 with HCC). A significantly higher proportion of patients with HCC who received lusutrombopag achieved the primary end point (68.0%) vs patients who received placebo (8.9%) (P < .0001); in patients without HCC, these proportions were 77.0% vs 21.6% (P < .0001). Lusutrombopag reduced the need for platelet transfusions, increased platelet counts for 3 weeks, and reduced the number of bleeding events in patients with and without HCC compared with placebo. Risk of thrombosis was similar to that of placebo.
CONCLUSIONS


Patients with and without HCC receiving lusutrombopag had a reduction in the number of platelet transfusions before invasive procedures compared with patients receiving placebo, with no increase in thrombosis or bleeding. L-PLUS 1: JapicCTI-132323; L-PLUS 2: ClinicalTrials.gov number no: NCT02389621.",2020,"The primary endpoint was no requirement for platelet transfusion before the invasive procedure or rescue therapies for bleeding 7 days or less after the invasive procedure.
","['patients with chronic liver disease, with and without HCC', '270 patients (95 with HCC', 'patients with ECOG grades of 0 or 1, Child', 'Patients with hepatocellular carcinoma (HCC', 'Patients With and Without Hepatocellular Carcinoma']","['placebo', 'lusutrombopag (3 mg) or placebo', 'Lusutrombopag', 'lusutrombopag to placebo']","['Risk of thrombosis', 'number of bleeding events', 'number of platelet transfusions', 'platelet counts', 'platelet transfusion', 'thrombosis or bleeding', 'asymptomatic portal vein thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4309207', 'cui_str': 'lusutrombopag'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis (disorder)'}]",,0.350149,"The primary endpoint was no requirement for platelet transfusion before the invasive procedure or rescue therapies for bleeding 7 days or less after the invasive procedure.
","[{'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Department of Metabolic Center, Texas Liver Institute, San Antonio, Texas. Electronic address: alkhouri@txliver.com.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Imawari', 'Affiliation': 'Institute for Gastrointestinal and Liver Disease, Shin-Yurigaoka General Hospital, Kawasaki, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Osaki', 'Affiliation': 'Meiwa Hospital, Nishinomiya, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Ochiai', 'Affiliation': 'Biostatistics Center, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kano', 'Affiliation': 'Global Project Management Department, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Bentley', 'Affiliation': 'Global Market Access, Shionogi, Inc, Florham Park, New Jersey.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Trevisani', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.032']
367,32402495,Non-suturing microvascular anastomosis in maxillofacial reconstruction- a comparative study.,"AIM


The aim of the study is to compare the advantages and disadvantages of non-suturing anastomotic methods over conventional microsuturing for microvascular venous anastomosis.
MATERIALS AND METHODS


All patients reporting to the institute for hard and soft tissue reconstruction (Primary/secondary) were enrolled in the study. Patients with systemic comorbidities, peripheral vascular diseases, or anatomical aberration of the indicated donor site were excluded from the study. The patients selected for the study were randomly allocated to five groups of different techniques of venous anastomosis, namely Group I (conventional microsuturing), II (fibrin sealant reinforced microsuturing), III (couplers), IV (staplers), V (Laser Assisted Vascular Anastomosis (LAVA)). Intraoperative anastomotic time, flap ischaemic time, patency and leakage were the parameters that were assessed for all five groups.
RESULTS


80 Patients were randomly allocated to five groups and each group comprised 16 patients. The mean ischaemic time and standard deviation of Group I and Group II were 256.19 ± 10.622 min and 255.19 ± 11.083 min, and for groups III, IV, and V were 193.38 ± 9.972 min, 139.06 ± 6.413 min, and 139.31 ± 6.364 min respectively (p < 0.001). Mean anastomotic time and standard deviation were 19.813 ± 1.5366 min in Group I and 20.281 ± 1.6514 min in Group II. The non-sutured anastomosis groups III, IV, and V showed a mean anastomotic time of 5.375 ± 0.9876 min, 4.175 ± 0.7664 min, and 3.856 ± 0.867 min respectively (p value < 0.001). In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030). In Groups I and II, 18.8% and 6.3 % of patients respectively had leakage, whereas all patients in Groups III, IV, V had no leakage from the anastomotic site (p value 0.119).
CONCLUSION


Based on the results of the study, non-suturing techniques should be preferred over microsuturing technique whenever appropriate for venous anastomosis.",2020,"In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030).","['Patients with systemic comorbidities, peripheral vascular diseases, or anatomical aberration of the indicated donor site were excluded from the study', 'All patients reporting to the institute for hard and soft tissue reconstruction (Primary/secondary) were enrolled in the study', '80 Patients']","['venous anastomosis, namely Group I (conventional microsuturing), II (fibrin sealant reinforced microsuturing), III (couplers), IV (staplers), V (Laser Assisted Vascular Anastomosis (LAVA']","['Mean anastomotic time and standard deviation', 'mean ischaemic time and standard deviation', 'mean anastomotic time', 'leakage', 'Intraoperative anastomotic time, flap ischaemic time, patency and leakage', 'delayed patency', 'immediate patency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0450432', 'cui_str': 'Venous anastomosis'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016004', 'cui_str': 'Autologous Fibrin Tissue Adhesive'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C3665740', 'cui_str': 'Vascular anastomosis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0677554', 'cui_str': 'Anastomosis - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",80.0,0.0156835,"In Groups I and II, 18.8% of patients had delayed patency and in Groups III, IV and V, immediate patency was observed in all subjects (p value 0.030).","[{'ForeName': 'Surya Kiran', 'Initials': 'SK', 'LastName': 'Mudigonda', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: mudigondasuryakiran@gmail.com.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Murugan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, 600077, India. Electronic address: drmsenthilmurugan@gmail.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Velavan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: drvelavan@gmail.com.'}, {'ForeName': 'Selvakumar', 'Initials': 'S', 'LastName': 'Thulasiraman', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: selvakumaromfs@gmail.com.'}, {'ForeName': 'V B', 'Initials': 'VB', 'LastName': 'Krishna Kumar Raja', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu, 600089, India. Electronic address: kksukanya@gmail.com.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.04.005']
368,32402496,Does platelet-rich fibrin increase stability of the maxilla following Le Fort I osteotomy? A single-blind clinical trial study.,"This single-blind clinical trial study aimed to assess the efficacy of platelet-rich fibrin (PRF) in increasing stability following Le Fort I osteotomy for maxillary advancement. Patients who underwent Le Fort I osteotomy for maxillary advancement were assigned randomly into two groups: in group 1 (the study group, n = 22) PRF was placed in the osteotomy sites following fixation, while no PRF was used in group 2 (the control group, n = 22). Lateral cephalograms obtained preoperatively (T0), immediately after surgery (T1), and 1 year after surgery (T2) were compared between the two groups, and the amount of relapse was determined. The amount of maxillary change (relapse) at the A point in relation to the x-axis was 0.45 ± 0.67 mm in group 1 and 1.86 ± 0.56 mm in group 2. There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001). The mean maxillary change (relapse) in relation to the y-axis was 0.77 ± 1.15 mm in group 1 and 2.25 ± 1.22 mm in group 2. Analysis of the data demonstrated a significant difference in mean relapse in relation to the y-axis between the two groups (p < 0.001). PRF may enhance the stability of the maxilla following Le Fort I osteotomy. Based on the results of this study the administration of PRF should be considered whenever possible.",2020,There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001).,"['I osteotomy for maxillary advancement', 'Patients who underwent Le Fort']","['PRF', 'platelet-rich fibrin (PRF', 'PRF was placed in the osteotomy sites following fixation, while no PRF']","['amount of maxillary change (relapse', 'mean relapse', 'mean maxillary change (relapse']","[{'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.034354,There was a significant difference in mean relapse in relation to the x-axis between the two groups 12 months after osteotomy (p < 0.001).,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Tabrizi', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mirmohammad Sadeghi', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Bakhshaei', 'Affiliation': 'Oral and Maxillofacial Surgery, Dental School, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Bakhshaei.pedram@gmail.com.'}, {'ForeName': 'Birkan Taha', 'Initials': 'BT', 'LastName': 'Ozkan', 'Affiliation': 'Oral and Maxillofacial Surgery, Toros University, Institute of Health Science, Toros, Turkey.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.04.007']
369,32402504,"Response to Letter Regarding ""A Randomized Controlled Trial on the Effects of Low-Dose Extracorporeal Shockwave Therapy in Patients With Knee Osteoarthritis"".",,2020,,['Patients With Knee Osteoarthritis'],['Low-Dose Extracorporeal Shockwave Therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]",[],,0.046562,,"[{'ForeName': 'Zongye', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bangzhong', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Deparment of Radiology, Huashan Hospital, Fudan University, Shanghai, China.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.03.008']
370,31977825,Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multicenter Randomized Controlled Trial.,"BACKGROUND


Almost one-third of patients with proximal humeral fractures are treated surgically, and the number is increasing. When surgical treatment is chosen, there is sparse evidence on the optimum method. The DelPhi (Delta prosthesis-PHILOS plate) trial is a clinical trial comparing 2 surgical treatments. Our hypothesis was that reverse total shoulder arthroplasty (TSA) yields better clinical results compared with open reduction and internal fixation (ORIF) using an angular stable plate.
METHODS


The DelPhi trial is a randomized controlled trial comparing reverse TSA with ORIF for displaced proximal humeral fractures (OTA/AO types 11-B2 and 11-C2) in elderly patients (65 to 85 years of age). The primary outcome measure was the Constant score at a 2-year follow-up. The secondary outcome measures included the Oxford Shoulder Score and radiographic evaluation. Results were reported as the mean difference with 95% confidence interval (CI). The intention-to-treat principle was applied for crossover patients.
RESULTS


There were 124 patients included in the study. At 2 years, the mean Constant score was 68.0 points (95% CI, 63.7 to 72.4 points) for the reverse TSA group compared with 54.6 points (95% CI, 48.5 to 60.7 points) for the ORIF group, resulting in a significant mean difference of 13.4 points (95% CI, 6.2 to 20.6 points; p < 0.001) in favor of reverse TSA. When stratified for fracture classification, the mean score was 69.3 points (95% CI, 63.9 to 74.7 points) for the reverse TSA group and 50.6 points (95% CI, 41.9 to 59.2 points) for the ORIF group for type-C2 fractures, which yielded a significant mean difference of 18.7 points (95% CI, 9.3 to 28.2 points; p < 0.001). In the type-B2 fracture group, the mean score was 66.2 points (95% CI, 58.6 to 73.8 points) for the reverse TSA group and 58.5 points (95% CI, 49.6 to 67.4 points) for the ORIF group, resulting in a nonsignificant mean difference of 7.6 points (95% CI, -3.8 to 19.1 points; p = 0.19).
CONCLUSIONS


At a 2-year follow-up, the data suggested an advantage of reverse TSA over ORIF in the treatment of displaced OTA/AO type-B2 and C2 proximal humeral fractures in elderly patients.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"At 2 years, the mean Constant score was 68.0 points (95% CI, 63.7 to 72.4 points) for the reverse TSA group compared with 54.6 points (95% CI, 48.5 to 60.7 points) for the ORIF group, resulting in a significant mean difference of 13.4 points (95% CI, 6.2 to 20.6 points; p < 0.001) in favor of reverse TSA.","['elderly patients (65 to 85 years of age', '124 patients included in the study', 'elderly patients', 'patients with proximal humeral fractures']","['Reverse Shoulder Arthroplasty Is Superior to Plate Fixation', 'TSA', 'TSA with ORIF']","['mean score', 'Constant score at a 2-year follow-up', 'Oxford Shoulder Score and radiographic evaluation', 'mean Constant score', 'internal fixation (ORIF', 'total shoulder arthroplasty ']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0037006', 'cui_str': 'Humeral Fractures, Proximal'}]","[{'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1872220', 'cui_str': '(125I)-TSA'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}]",124.0,0.228799,"At 2 years, the mean Constant score was 68.0 points (95% CI, 63.7 to 72.4 points) for the reverse TSA group compared with 54.6 points (95% CI, 48.5 to 60.7 points) for the ORIF group, resulting in a significant mean difference of 13.4 points (95% CI, 6.2 to 20.6 points; p < 0.001) in favor of reverse TSA.","[{'ForeName': 'Alexander Nilsskog', 'Initials': 'AN', 'LastName': 'Fraser', 'Affiliation': 'Division of Orthopaedic Surgery (A.N.F., T.M.W., J.E.M., and T.F.), and Division of Radiology and Nuclear Medicine, Department of Musculoskeletal Radiology (A.C.K.), Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bjørdal', 'Affiliation': 'Department of Orthopedic Surgery, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Tone Mehlum', 'Initials': 'TM', 'LastName': 'Wagle', 'Affiliation': 'Division of Orthopaedic Surgery (A.N.F., T.M.W., J.E.M., and T.F.), and Division of Radiology and Nuclear Medicine, Department of Musculoskeletal Radiology (A.C.K.), Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anna Cecilia', 'Initials': 'AC', 'LastName': 'Karlberg', 'Affiliation': 'Division of Orthopaedic Surgery (A.N.F., T.M.W., J.E.M., and T.F.), and Division of Radiology and Nuclear Medicine, Department of Musculoskeletal Radiology (A.C.K.), Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Odd Arve', 'Initials': 'OA', 'LastName': 'Lien', 'Affiliation': 'Department of Orthopedic Surgery, Vestre Viken Hospital Trust, Bærum Hospital, Bærum, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Eilertsen', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Mader', 'Affiliation': 'Division of Hand, Forearm and Elbow Traumatology, Department of Trauma, Hand and Reconstructive Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Apold', 'Affiliation': 'Department of Orthopedic Surgery, Telemark Hospital, Skien, Norway.'}, {'ForeName': 'Leif Børge', 'Initials': 'LB', 'LastName': 'Larsen', 'Affiliation': 'Department of Orthopedic Surgery, Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Madsen', 'Affiliation': 'Division of Orthopaedic Surgery (A.N.F., T.M.W., J.E.M., and T.F.), and Division of Radiology and Nuclear Medicine, Department of Musculoskeletal Radiology (A.C.K.), Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Fjalestad', 'Affiliation': 'Division of Orthopaedic Surgery (A.N.F., T.M.W., J.E.M., and T.F.), and Division of Radiology and Nuclear Medicine, Department of Musculoskeletal Radiology (A.C.K.), Oslo University Hospital, Oslo, Norway.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01071']
371,30950680,Comparative Study Between Topical Gatifloxacin 0.5% and Moxifloxacin 0.5% as a Prophylactic Measure Before Intraocular Surgery.,"Purpose:  To compare equal concentrations (0.5%) of moxifloxacin and gatifloxacin ophthalmic solutions with regard to conjunctival bacterial reduction as well as anterior chamber penetration.  Methods:  One hundred patients were divided into 2 groups. Group A received moxifloxacin 0.5% ophthalmic solution and group B received gatifloxacin 0.5% ophthalmic solution 4 times a day for 3 days before surgery and 5 times with 30 min intervals on the day of surgery. Two conjunctival swabs were obtained: one before instillation of antibiotic and the second 30 min after instillation of the last antibiotic drop. Specimens were sent for culture and susceptibility testing. At the time of surgery, 0.1 mL of aqueous fluid was aspired, and aqueous concentration of fluoroquinolones was identified using reverse-phase high-pressure liquid chromatography assay technique.  Results:  The most common flora isolated was coagulase-negative  Staphylococcus  (32.9%), followed by  Staphylococcus aureus  (24.8%) and  Corynebacterium diphtheria  (19.1%). Moxifloxacin aqueous concentration was higher compared with gatifloxacin [1.75 ± 0.98 standard deviation (SD) and 0.75 ± 0.22 SD, respectively]. This 2.3-fold difference in aqueous humor antibiotic concentrations was statistically significant ( P  ≤ 0.001). There was significant difference between the means of conjunctival colony-forming unit after antibiotic administration in both the study groups (2.17 ± 1.54 SD in group A and 1.56 ± 1.09 SD in group B).  Conclusions:  Moxifloxacin 0.5% was found to penetrate anterior chamber more than gatifloxacin 0.5%, enforcing its use for prophylaxis before intraocular surgeries. However, gatifloxacin 0.5% eye drops were able to reduce conjunctival bacterial load, more supporting its use before extraocular and refractive surgeries.",2019,This 2.3-fold difference in aqueous humor antibiotic concentrations was statistically significant ( P  ≤ 0.001).,['One hundred patients'],"['Topical Gatifloxacin', 'gatifloxacin 0.5% ophthalmic solution', 'Moxifloxacin', 'gatifloxacin', 'moxifloxacin and gatifloxacin ophthalmic solutions', 'moxifloxacin 0.5% ophthalmic solution']","['conjunctival colony-forming unit after antibiotic administration', 'Moxifloxacin aqueous concentration', 'conjunctival bacterial load', 'aqueous humor antibiotic concentrations']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0753645', 'cui_str': 'gatifloxacin'}, {'cui': 'C2917458', 'cui_str': 'gatifloxacin 0.5 % Ophthalmic Solution'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1321748', 'cui_str': 'gatifloxacin Ophthalmic Solution'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0029083', 'cui_str': 'Ophthalmic Solution'}]","[{'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0003662', 'cui_str': 'Intraocular Fluid'}]",100.0,0.0293178,This 2.3-fold difference in aqueous humor antibiotic concentrations was statistically significant ( P  ≤ 0.001).,"[{'ForeName': 'Asser Ahmed Ehsan', 'Initials': 'AAE', 'LastName': 'Abdel-Meguid', 'Affiliation': '1 Department of Ophthalmology, Fayoum University Faculty of Medicine, Fayoum, Egypt.'}, {'ForeName': 'Ahmed Fathy', 'Initials': 'AF', 'LastName': 'Gabr', 'Affiliation': '3 Department of Ophthalmology, Aswan University Faculty of Medicine, Aswan, Egypt.'}, {'ForeName': 'Mohamed Mostafa', 'Initials': 'MM', 'LastName': 'Said', 'Affiliation': '1 Department of Ophthalmology, Fayoum University Faculty of Medicine, Fayoum, Egypt.'}, {'ForeName': 'Mohamed Abd El Hamid', 'Initials': 'MAEH', 'LastName': 'Nassef', 'Affiliation': '1 Department of Ophthalmology, Fayoum University Faculty of Medicine, Fayoum, Egypt.'}, {'ForeName': 'Tarek Mohamed Ibrahim', 'Initials': 'TMI', 'LastName': 'Elmenofy', 'Affiliation': '1 Department of Ophthalmology, Fayoum University Faculty of Medicine, Fayoum, Egypt.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2018.0088']
372,32402681,A Randomized Phase II Study of Perioperative Chemotherapy Plus Bevacizumab Versus Postoperative Chemotherapy Plus Bevacizumab in Patients With Upfront Resectable Hepatic Colorectal Metastases.,"INTRODUCTION


Whether patients with resectable colorectal liver metastases (CRLM) gain a survival benefit from perioperative chemotherapy remains controversial. The benefit of including bevacizumab in chemotherapy also remains unclear.
MATERIAL AND METHODS


Seventy-six patients with CRLM were randomly assigned to either 6 cycles of FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin)/FOLFIRI (folinic acid, 5-fluorouracil, and irinotecan) with bevacizumab before and after surgery or 12 cycles after surgery. Progression-free survival (PFS) was estimated using the Kaplan-Meier method and compared by the log-rank test.
RESULTS


The median PFS of all patients was 37.4 months at 5.4 years follow-up, and the median overall survival (OS) was not reached. The PFS between the perioperative group and the postoperative group did not reveal a statistical difference (P = .280). The OS was significantly better in the perioperative group (hazard ratio [HR], 0.60; 95% confidence interval [CI],) 0.35-1.02; P = .049). In subgroup patients with carcinoembryonic antigens (CEA) ≥ 5 ng/mL or those with over 2 liver metastases, perioperative group had longer OS than postoperative group (CEA: HR, 0.49; 95% CI, 0.25-0.93; P = .030; number of liver metastases: HR, 0.55; 95% CI, 0.30-0.99; P = .049). The largest liver metastases size, disease-free interval, and sidedness did not affect PFS or OS. There was no difference between the 2 groups in postoperative complications with bevacizumab or adverse events during chemotherapy.
CONCLUSIONS


In patients with resectable CRLMs, perioperative chemotherapy had no effect on PFS, but improved OS. Patients with high CEA levels or over 2 liver metastases may benefit from perioperative chemotherapy.",2020,"The OS was significantly better in the perioperative group (hazard ratio [HR], 0.60; 95% confidence interval [CI],) 0.35-1.02; P = .049).","['Seventy-six patients with CRLM', 'patients with resectable colorectal liver metastases (CRLM', 'Patients', 'Patients with high CEA levels or over 2 liver metastases']","['Perioperative Chemotherapy Plus Bevacizumab Versus Postoperative Chemotherapy Plus Bevacizumab', 'bevacizumab', 'FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin)/FOLFIRI (folinic acid, 5-fluorouracil, and irinotecan) with bevacizumab']","['Progression-free survival (PFS', 'PFS, but improved OS', 'median overall survival (OS', 'postoperative complications', 'adverse events', 'median PFS']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",76.0,0.16738,"The OS was significantly better in the perioperative group (hazard ratio [HR], 0.60; 95% confidence interval [CI],) 0.35-1.02; P = .049).","[{'ForeName': 'You Jin', 'Initials': 'YJ', 'LastName': 'Chun', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seong-Geun', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Division of Hemato-Oncology, On Hospital, Cancer Center, Busan, South Korea.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Sang Hee', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, South Korea.'}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Baek', 'Affiliation': 'Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Young Suk', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Soojung', 'Initials': 'S', 'LastName': 'Hong', 'Affiliation': 'Division of Oncology-Hematology, Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, South Korea.'}, {'ForeName': 'Chong Woo', 'Initials': 'CW', 'LastName': 'Chu', 'Affiliation': 'Divison of Hepato-biliary Surgery, Vinmec International Hospital, Hanoi, Vietnam.'}, {'ForeName': 'Seung-Hoon', 'Initials': 'SH', 'LastName': 'Beom', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Minkyu', 'Initials': 'M', 'LastName': 'Jung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Joon', 'Initials': 'SJ', 'LastName': 'Shin', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joong Bae', 'Initials': 'JB', 'LastName': 'Ahn', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea. Electronic address: vvswm513@yuhs.ac.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2020.03.004']
373,32404132,Rehabilitation of older people with Parkinson's disease: an innovative protocol for RCT study to evaluate the potential of robotic-based technologies.,"BACKGROUND


Parkinson's disease is one of the most frequent causes of disability among the older adults. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease. Therefore, physiotherapy becomes an important intervention for the management of motor disorders. Originally, these rehabilitative approaches were based on empirical experiences, but several scientific evidences suggests that neuronal plasticity is exercise-dependent. In this context, robotic rehabilitation plays an important role because it allows to perform task-oriented exercises and to increase the number of repetitions and their intensity. This protocol study aims to evaluate the effectiveness of robotic-based intervention of the older adults with Parkinson's disease, designed to improve the gait and to reduce the risk of falling.
METHODS


This study is a single-blinded randomized controlled trial. The primary outcomes are: risk of falling, gait performance and fear of falling measured through Performance-Oriented Mobility Assessment (POMA), instrumental gait analysis and Short Falls Efficacy Scale - International (FES-I), respectively. One hundred ninety-five patients with PD will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation using Tymo system or Walker View in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. A 10-treatment session will be conducted, divided into 2 training sessions per week, for 5 weeks. The control group will perform traditional therapy sessions lasting 50 min. The technological intervention group will carry out 30 min of traditional therapy and 20 min of treatment with a robotic system.
DISCUSSION


The final goals of the present study are to propose a new approach in the PD rehabilitation, focused on the use of robotic device, and to check the results not only at the end of the treatment but also in the long term.
TRIAL REGISTRATION


NCT04087031, registration date September 12, 2019.",2020,Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease.,"['One hundred ninety-five patients with PD', ""older people with Parkinson's disease"", ""older adults with Parkinson's disease""]","['traditional rehabilitation program or a robotic rehabilitation using Tymo system or Walker View in addition to the traditional therapy', 'robotic-based intervention']","['risk of falling, gait performance and fear of falling measured through Performance-Oriented Mobility Assessment (POMA), instrumental gait analysis and Short Falls Efficacy Scale - International (FES-I), respectively']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C2919878', 'cui_str': 'Short falls efficacy scale - international'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}]",,0.0298868,Balance disorders are a symptom that involves the body axis and do not respond to dopaminergic therapy used in Parkinson's disease.,"[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bevilacqua', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy. r.bevilacqua@inrca.it.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Maranesi', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Di Rosa', 'Affiliation': 'Unit of Geriatric Pharmacoepidemiology, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Luzi', 'Affiliation': 'Medical Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Casoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rinaldi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Baldoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Lattanzio', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Di Donna', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pelliccioni', 'Affiliation': 'Neurology Unit, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Giovanni Renato', 'Initials': 'GR', 'LastName': 'Riccardi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}]",BMC neurology,['10.1186/s12883-020-01759-4']
374,32404133,Efficacy of a physical activity programme combining individualized aerobic exercise and coaching to improve physical fitness in neuromuscular diseases (I'M FINE): study protocol of a randomized controlled trial.,"BACKGROUND


In individuals with neuromuscular diseases (NMD), symptoms of muscle weakness, fatigue and pain may limit physical activity. Inactivity leads to reduced physical fitness, which further complicates daily life functioning. Due to inconclusive evidence regarding exercise in NMD, the optimal training approach and strategies to preserve an active lifestyle remain to be determined. The physical activity programme I'M FINE, consisting of individualized aerobic exercise to improve physical fitness and coaching to preserve an active lifestyle, was therefore developed. The primary objective of this study will be to evaluate the efficacy of the I'M FINE programme in terms of improved physical fitness in individuals with slowly progressive NMD, compared to usual care.
METHODS


A multicentre, assessor-blinded, two armed, randomized controlled trial will be conducted in a sample of 90 individuals with slowly progressive NMD. Participants motivated to improve their reduced physical fitness will be randomized (ratio 1:1) to the I'M FINE intervention or usual care. The I'M FINE intervention consists of a six-month physical activity programme, including individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle. Measurements will be performed at baseline, post-intervention, and at 12- and 18-months follow-up. The primary outcome is peak oxygen uptake (VO 2  peak) directly post intervention. Main secondary outcomes are physical capacity, muscle strength, self-efficacy, daily activity, quality of life and markers of metabolic syndrome. The primary analysis compares change in VO 2  peak post-intervention between the intervention and usual care group, with analysis of covariance.
DISCUSSION


The I'M FINE study will provide evidence regarding the efficacy of a physical activity intervention on the physical fitness and active lifestyle over the short- and long-term in individuals with slowly progressive NMD. These outcomes could potentially improve the (inter)national guidelines for efficacy of aerobic exercise programmes and provide insight in achieving a more active lifestyle in NMD.
TRIAL REGISTRATION


(5/11/2018): Netherlands Trial Register NTR7609 (retrospectively registered), https://www.trialregister.nl/trial/7344. However, the Ethics Review Committee of the Amsterdam Medical Center (AMC) approved the study protocol on 7/11/2017. No adjustments were made to the approved study protocol before the first participant enrolment and registration. Registration was done after the second participant enrolment and the information in the register corresponds one on one with the approved study protocol.",2020,"The I'M FINE intervention consists of a six-month physical activity programme, including individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle.","['individuals with slowly progressive NMD', 'individuals with neuromuscular diseases (NMD', ""neuromuscular diseases (I'M FINE"", '90 individuals with slowly progressive NMD']","['physical activity intervention', ""I'M FINE programme"", 'physical activity programme combining individualized aerobic exercise and coaching', 'aerobic exercise programmes', 'individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle', 'individualized aerobic exercise']","['physical fitness', 'peak oxygen uptake (VO 2  peak', 'physical capacity, muscle strength, self-efficacy, daily activity, quality of life and markers of metabolic syndrome']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0205232', 'cui_str': 'Fine'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",90.0,0.0860636,"The I'M FINE intervention consists of a six-month physical activity programme, including individualized home-based aerobic exercise to improve physical fitness (i.e. peak oxygen uptake), and motivational interviewing coaching (e.g. goal setting, self-management) to adopt and preserve an active lifestyle.","[{'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Oorschot', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. s.oorschot@amsterdamumc.nl.'}, {'ForeName': 'Merel A', 'Initials': 'MA', 'LastName': 'Brehm', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Annerieke C', 'Initials': 'AC', 'LastName': 'van Groenestijn', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Fieke S', 'Initials': 'FS', 'LastName': 'Koopman', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Camiel', 'Initials': 'C', 'LastName': 'Verhamme', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Eftimov', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith G M', 'Initials': 'JGM', 'LastName': 'Jelsma', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam UMC, VU University Medical Center, de Boelelaan 1118, Amsterdam, The Netherlands.'}, {'ForeName': 'Harald T', 'Initials': 'HT', 'LastName': 'Jorstad', 'Affiliation': 'Department of Cardiology, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Nollet', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Voorn', 'Affiliation': 'Department of Rehabilitation, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}]",BMC neurology,['10.1186/s12883-020-01725-0']
375,32205528,Placebo hypoalgesia: racial differences.,"No large-cohort studies that examine potential racial effects on placebo hypoalgesic effects exist. To fill this void, we studied placebo effects in healthy and chronic pain participants self-identified as either African American/black (AA/black) or white. We enrolled 372 study participants, 186 with a diagnosis of temporomandibular disorder (TMD) and 186 race-, sex-, and age-matched healthy participants to participate in a placebo experiment. Using a well-established paradigm of classical conditioning with verbal suggestions, each individual pain sensitivity was measured to calibrate the temperatures for high- and low-pain stimuli in the conditioning protocol. These 2 temperatures were then paired with a red and green screen, respectively, and participants were told that the analgesic intervention would activate during the green screens to reduce pain. Participants then rated the painfulness of each stimulus on a visual analog scale ranging from 0 to 100. Racial influences were tested on conditioning strength, reinforced expectations, and placebo hypoalgesia. We found that white participants reported greater conditioning effects, reinforced relief expectations, and placebo effects when compared with their AA/black counterparts. Racial effects on placebo were observed in TMD, although negligible, short-lasting, and mediated by conditioning strength. Secondary analyses on the effect of experimenter-participant race and sex concordance indicated that same experimenter-participant race induced greater placebo hypoalgesia in TMDs while different sex induced greater placebo hypoalgesia in healthy participants. This is the first and largest study to analyze racial effects on placebo hypoalgesia and has implications for both clinical research and treatment outcomes.",2020,Secondary analyses on the effect of experimenter-participant race and sex concordance indicated that same experimenter-participant race induced greater placebo hypoalgesia in TMDs while different sex induced greater placebo hypoalgesia in healthy participants.,"['healthy and chronic pain participants self-identified as either African-American/Black (AA/Black) or White', 'healthy participants', 'We enrolled 372 study participants, 186 with a diagnosis of temporomandibular disorder (TMD) and 186 race, sex, and age matched healthy participants to participate in a placebo experiment']","['Placebo', 'placebo']",['painfulness of each stimulus on a Visual Analog Scale'],"[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",372.0,0.230201,Secondary analyses on the effect of experimenter-participant race and sex concordance indicated that same experimenter-participant race induced greater placebo hypoalgesia in TMDs while different sex induced greater placebo hypoalgesia in healthy participants.,"[{'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Okusogu', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Titilola', 'Initials': 'T', 'LastName': 'Akintola', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Nathaniel R', 'Initials': 'NR', 'LastName': 'Haycock', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Greenspan', 'Affiliation': 'Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Department of Neural and Pain Sciences and Brotman Facial Pain Clinic, School of Dentistry, Baltimore, MD, United States.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Dorsey', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}]",Pain,['10.1097/j.pain.0000000000001876']
376,31548678,Brain regulation of emotional conflict predicts antidepressant treatment response for depression.,"The efficacy of antidepressant treatment for depression is controversial due to the only modest superiority demonstrated over placebo. However, neurobiological heterogeneity within depression may limit overall antidepressant efficacy. We sought to identify a neurobiological phenotype responsive to antidepressant treatment by testing pretreatment brain activation during response to, and regulation of, emotional conflict as a moderator of the clinical benefit of the antidepressant sertraline versus placebo. Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes. Treatment-predictive machine learning using brain metrics outperformed a model trained on clinical and demographic variables. Our findings demonstrate that antidepressant response is predicted by brain activity underlying a key self-regulatory emotional capacity. Leveraging brain-based measures in psychiatry will forge a path toward better treatment personalization, refined mechanistic insights and improved outcomes.",2019,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0530251,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0732-1']
377,31757776,Promoting psychological health in women with SCI: Development of an online self-esteem intervention.,"BACKGROUND


There are no known interventions addressing self-esteem in women following spinal cord injury (SCI).
OBJECTIVES


To test the feasibility of an online self-esteem intervention for women with disabilities, as modified for women with SCI.
METHOD


We conducted a randomized, controlled feasibility test of a self-esteem intervention (N = 21). Participants were randomly assigned to the intervention or control group that received intervention materials at the end of the study. Intervention participants met as avatars for 7 weekly real-time group sessions in Second Life (SL), a free online virtual world. Feasibility indicators were study engagement, acceptability of SL and the intervention, and improvements on measures of psychological health promoting behaviors, social support, self-efficacy, self-esteem, and depression.
RESULTS


Intervention participants (n = 10) were highly engaged, and most described the SL program as more enjoyable and more convenient than in-person programs. All rated the intervention as ""good"" (n = 4) or ""very good"" (n = 6), and all 10 rated themselves has having made positive life changes as a result of the program. Intervention participants experienced significantly greater change than controls on two measures of health-promoting behavior (Health Promoting Lifestyle Profile-II Spiritual Growth/Self-actualization; Interpersonal Relations). Examining change in the intervention group using regression analyses, we found medium-to-large effects of the intervention on these behaviors and measures of depression (CESD-10, PHQ-9). The intervention had small effects on remaining measures.
CONCLUSION


We found preliminary support for the feasibility of this modified self-esteem intervention offered in SL. Such programming may help circumvent barriers to community-based psychological services and may improve psychological health.",2020,Intervention participants experienced significantly greater change than controls on two measures of health-promoting behavior (Health Promoting Lifestyle Profile-II Spiritual Growth/Self-actualization; Interpersonal Relations).,"['women with disabilities, as modified for women with SCI', 'women following spinal cord injury (SCI', 'women with SCI']","['online self-esteem intervention', 'self-esteem intervention']","['health-promoting behavior (Health Promoting Lifestyle Profile-II Spiritual Growth/Self-actualization; Interpersonal Relations', 'behaviors and measures of depression (CESD-10, PHQ-9', 'psychological health promoting behaviors, social support, self-efficacy, self-esteem, and depression']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}]","[{'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0687002', 'cui_str': 'Spiritual growth (observable entity)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",,0.0352385,Intervention participants experienced significantly greater change than controls on two measures of health-promoting behavior (Health Promoting Lifestyle Profile-II Spiritual Growth/Self-actualization; Interpersonal Relations).,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Robinson-Whelen', 'Affiliation': 'Spinal Cord Injury and Disability Research Center, TIRR Memorial Hermann, Houston, TX, USA; Center for Research on Women with Disabilities, H. Ben Taub Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX, USA. Electronic address: susanrw@bcm.edu.'}, {'ForeName': 'Rosemary B', 'Initials': 'RB', 'LastName': 'Hughes', 'Affiliation': 'The Rural Institute for Inclusive Communities, University of Montana, Missoula, MT, USA; Department of Psychology, University of Montana, Missoula, MT, USA.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Taylor', 'Affiliation': 'Spinal Cord Injury and Disability Research Center, TIRR Memorial Hermann, Houston, TX, USA; McGovern Medical School at the University of Texas Health Science Center at Houston (UTHealth), USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Markley', 'Affiliation': 'Spinal Cord Injury and Disability Research Center, TIRR Memorial Hermann, Houston, TX, USA.'}, {'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Vega', 'Affiliation': 'Spinal Cord Injury and Disability Research Center, TIRR Memorial Hermann, Houston, TX, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Nosek', 'Affiliation': 'Department of Physiology and Biophysics, Case Western Reserve University, School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Nosek', 'Affiliation': 'Center for Research on Women with Disabilities, H. Ben Taub Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX, USA.'}]",Disability and health journal,['10.1016/j.dhjo.2019.100867']
378,32040875,"Atraumatic restorative treatments reduce the need for dental general anaesthesia: a non-inferiority randomized, controlled trial.","BACKGROUND


A dental general anaesthesia (DGA) is commonly undertaken for the management of dental caries in young children. A randomized-controlled trial was undertaken to test the feasibility of using the Atraumatic Restorative Treatment and Hall Technique approaches (ART/HT) to manage the dental treatment of children recommended for a DGA.
METHODS


Consenting children, recommended a DGA for caries management, at the Oral Health Centre of Western Australia were randomized. Test group children were treated using the ART/HT approach and the control group under a DGA. Children were examined after 12 months by two blinded, calibrated examiners. Analysis was on an intention to treat basis; between and within group comparisons were undertaken using appropriate paired and unpaired tests. Logistic regression was used to test restorative success, controlling for clustering of teeth.
RESULTS


Sixty-five children participated, (Test = 32; Control = 33). At study termination, 28 children (88%) in the ART/HT group and 20 children (61%) in the DGA group had been provided with care, P < 0.01. Crown restorations were protective of restorative failure in a multivariate logistic model (OR 0.05, P < 0.01).
CONCLUSION


Use of the ART/HT approach enabled timely dental treatment of young children recommended for a DGA, and should be among the treatment options considered.",2020,"Crown restorations were protective of restorative failure in a multivariate logistic model (OR 0.05, p<0.01).
","['Dental General Anaesthesia', 'children recommended for a DGA', 'young children', '28 children (88%) in the ART/HT group and 20 children (61%) in the DGA group had been provided with care, p<0.01', 'Consenting children, recommended a DGA for caries management, at the Oral Health Centre of Western Australia were randomised']","['ART/HT approach and the control group under a DGA', 'dental general anaesthesia (DGA', 'Atraumatic Restorative Treatment and Hall Technique approaches (ART/HT', 'ART/HT approach', 'Atraumatic Restorative Treatments']",[],"[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0029162'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2356088', 'cui_str': 'Halls'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]",[],65.0,0.148147,"Crown restorations were protective of restorative failure in a multivariate logistic model (OR 0.05, p<0.01).
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Arrow', 'Affiliation': 'Dental Health Services, Perth, Western Australia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Forrest', 'Affiliation': 'Dental Health Services, Perth, Western Australia.'}]",Australian dental journal,['10.1111/adj.12749']
379,31994303,Comparison of the effects of oral iron treatment every day and every other day in female patients with iron deficiency anaemia.,"BACKGROUND


It is known that daily divided doses and high doses of iron increase hepcidin and reduce iron absorption.
AIM


This study aimed to compare treatments of iron replacement every other day at low doses, once a day and twice a day in terms of their effectiveness and frequencies of side effects.
METHODS


For a month, Group I received 270 mg ferrous sulphate twice a day (total elemental iron dose: 160 mg/day), Group II received 270 mg ferrous sulphate once a day (total elemental iron dose: 80 mg/day), and Group III received 270 mg ferrous sulphate every other day (total elemental iron dose: 80 mg/every other day). Intragroup and intergroup statistical analyses were carried out.
RESULTS


Haemoglobin (Hb) increased significantly in all three groups (P = 0.00). The increase in Hb levels was similar among the groups (P = 0.09). Ferritin significantly increased in all three groups after the treatment (P = 0.00). The increase in ferritin in Group I was significantly higher than those in Groups II and III (P < 0.05). Gastrointestinal tract (GIS) side effects were also significantly higher in Group I in comparison to the others (P = 0.001).
CONCLUSIONS


A low-dosage of iron treatment every other day may be used in the place of providing iron once or twice every day with similar effectiveness and lower rates of GIS side effects.",2020,"GIS side effects were also significantly higher in Group I in comparison to the others (p: 0.001).
",['Female Patients with Iron Deficiency Anemia'],"['Oral Iron Treatment', 'ferrous sulfate']","['Hemoglobin (Hb', 'Ferritin', 'Hb levels', 'increase in ferritin', 'GIS side effects']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0205757,"GIS side effects were also significantly higher in Group I in comparison to the others (p: 0.001).
","[{'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Düzen Oflas', 'Affiliation': 'Faculty of Medicine, Department of Internal Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Demircioğlu', 'Affiliation': 'Faculty of Medicine, Department of Hematology, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Narin', 'Initials': 'N', 'LastName': 'Yıldırım Doğan', 'Affiliation': 'Department of Internal Medicine, Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Elife', 'Initials': 'E', 'LastName': 'Eker', 'Affiliation': 'Department of Internal Medicine, Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kutlucan', 'Affiliation': 'Department of Hematology, Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Doğan', 'Affiliation': 'Faculty of Medicine, Department of Hematology, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Aslan', 'Affiliation': 'Faculty of Medicine, Department of Internal Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Cengiz', 'Initials': 'C', 'LastName': 'Demir', 'Affiliation': 'Faculty of Medicine, Department of Hematology, Van Yüzüncü Yıl University, Van, Turkey.'}]",Internal medicine journal,['10.1111/imj.14766']
380,32199608,The Cost-effectiveness of Eltrombopag for the Treatment of Immune Thrombocytopenia in the United States.,"PURPOSE


Eltrombopag was evaluated as a second-line treatment for adult chronic immune thrombocytopenia (ITP) in the 2006 Phase III RAISE (Eltrombopag for Management of Chronic Immune Thrombocytopenia) randomized, placebo-controlled trial. More than 80% of patients reached satisfactory platelet counts within 2 weeks. However, the economic value of eltrombopag as a second-line treatment for ITP remains to be formally assessed. This study aimed to estimate the cost-effectiveness of treating ITP with a comparable thrombopoietin receptor agonist (eltrombopag vs romiplostim).
METHODS


A Markov model was implemented over a lifetime time horizon to estimate the benefits and costs of each treatment. The model featured 3 health states based on current guidelines: (1) on treatment; (2) treatment failure/discontinuation; and (3) mortality. In line with therapeutic goals in ITP, model patients could experience 3 events: no bleeding, mild/moderate bleeding, or severe bleeding. Data on eltrombopag use were obtained from an open-label extension of previous Phase II/III trials, including RAISE. Romiplostim data were obtained from Phase III trials and an extension study. Lifetime overall survival was extrapolated by using treatment-specific mortality rates derived from severe bleeding and natural mortality rates. The costs of drugs, routine care, bleeding episodes, adverse events, and mortality were represented in the model.
FINDINGS


Eltrombopag-treated patients gained 17.58 life years and 14.68 quality-adjusted life years, whereas romiplostim-treated patients gained 17.52 life years and 14.67 quality-adjusted life years. The total lifetime cost of eltrombopag treatment was estimated at $1.58 million versus $2.13 million for romiplostim. Sensitivity analyses supported base case findings. Deterministic sensitivity analysis predicted the greatest sensitivity to the rates of severe bleeding, discontinuation, and natural mortality. Probabilistic sensitivity analysis showed that eltrombopag would be an efficient use of resources at a $50,000 threshold in 52.8% of cases. In all probabilistic iterations, the total cost of eltrombopag treatment was lower than with romiplostim, primarily because of lower drug costs.
IMPLICATIONS


Clinical data were applied in an economic analysis, and eltrombopag exhibited economic dominance compared with romiplostim, driven largely by the reduced costs of primary therapy. This model was limited by a lack of specific patient-level data and robust data on the duration of secondary therapy, as well as by the fact that utilization values are likely conservative estimates for routine care use.",2020,"In all probabilistic iterations, the total cost of eltrombopag treatment was lower than with romiplostim, primarily because of lower drug costs.
",['adult chronic immune thrombocytopenia (ITP) in the 2006 Phase III'],"['thrombopoietin receptor agonist (eltrombopag vs romiplostim', 'RAISE (Eltrombopag', 'placebo', 'Eltrombopag', 'eltrombopag']","['Lifetime overall survival', 'satisfactory platelet counts', 'costs of drugs, routine care, bleeding episodes, adverse events, and mortality', 'total lifetime cost of eltrombopag treatment', 'severe bleeding, discontinuation, and natural mortality', 'bleeding, mild/moderate bleeding, or severe bleeding', 'Immune Thrombocytopenia', 'total cost of eltrombopag treatment', 'Cost-Effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0272286', 'cui_str': 'Thrombocytopenia due to immune destruction'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4522005', 'cui_str': 'Thrombopoietin receptor agonist'}, {'cui': 'C1831905', 'cui_str': 'eltrombopag'}, {'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1831905', 'cui_str': 'eltrombopag'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0272286', 'cui_str': 'Thrombocytopenia due to immune destruction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0419083,"In all probabilistic iterations, the total cost of eltrombopag treatment was lower than with romiplostim, primarily because of lower drug costs.
","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Tremblay', 'Affiliation': 'Purple Squirrel Economics, New York, NY, USA. Electronic address: gabrieltremblay@pshta.com.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Dolph', 'Affiliation': 'Purple Squirrel Economics, New York, NY, USA.'}, {'ForeName': 'Anuja Nidumolu', 'Initials': 'AN', 'LastName': 'Roy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NY, USA.'}, {'ForeName': 'Qayyim', 'Initials': 'Q', 'LastName': 'Said', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NY, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Forsythe', 'Affiliation': 'Purple Squirrel Economics, New York, NY, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.02.020']
381,32199708,"Efficacy of Furosemide, Oral Sodium Chloride, and Fluid Restriction for Treatment of Syndrome of Inappropriate Antidiuresis (SIAD): An Open-label Randomized Controlled Study (The EFFUSE-FLUID Trial).","RATIONALE & OBJECTIVE


First-line therapy for syndrome of inappropriate antidiuresis (SIAD) is fluid restriction. Additional treatment for patients who do not respond to fluid restriction are water restriction with furosemide or water restriction with furosemide and salt supplementation. However, the efficacy of these treatments has never been tested in a randomized controlled study. The objective of this study was to investigate whether, combined with fluid restriction, furosemide with or without sodium chloride (NaCl) supplementation was more effective than fluid restriction alone in the treatment of hyponatremia in SIAD.
STUDY DESIGN


Open-label randomized controlled study.
SETTING & PARTICIPANTS


Patients with serum sodium concentrations ([Na + ]) ≤ 130mmol/L due to SIAD.
INTERVENTION(S)


Random assignment to 1 of 3 groups: fluid restriction alone (FR), fluid restriction and furosemide (FR+FM), or fluid restriction, furosemide, and NaCl (FR+FM+NaCl). Strictness of fluid restriction (<1,000 or<500mL/d) was guided by the urine to serum electrolyte ratio. Furosemide dosage was 20 to 40mg/d. NaCl supplements were 3g/d. All treatments were continued for 28 days.
OUTCOMES


The primary outcome was change in [Na + ] at days 4, 7, 14, and 28 after randomization.
RESULTS


92 patients were recruited (FR, n=31; FR+FM, n=30; FR+FM+NaCl, n=31). Baseline [Na + ] was 125±4mmol/L, and there were no significant differences between groups. Mean [Na + ] on day 4 in all treatment groups was significantly increased from baseline by 5mmol/L (P<0.001); however, the change in [Na + ] was not significantly different across groups (P=0.7). There was no significant difference in percentage of patients or time to reach [Na + ] ≥ 130 or≥135mmol/L across the 3 groups. Acute kidney injury and hypokalemia (potassium≤3.0mmol/L) were more common in patients receiving furosemide.
LIMITATIONS


Open-label treatment.
CONCLUSIONS


In patients with SIAD, furosemide with NaCl supplement in combination with fluid restriction did not show benefits in correction of [Na + ] compared with treatment with fluid restriction alone. Incidences of acute kidney injury and hypokalemia were increased in patients receiving furosemide.
FUNDING


None.
TRIAL REGISTRATION


Registered at the Thai Clinical Trial Registry with study number TCTR20170629004.",2020,There was no significant difference in percentage of patients or time to reach [Na + ] ≥ 130 or≥135mmol/L across the 3 groups.,"['patients receiving furosemide', 'Syndrome of Inappropriate Antidiuresis (SIAD', 'Patients with serum sodium concentrations ([Na + ])\xa0≤ 130mmol/L due to SIAD', 'patients who do not respond to fluid restriction are water restriction with', '92 patients were recruited (FR, n=31']","['fluid restriction alone (FR), fluid restriction and furosemide (FR+FM), or fluid restriction, furosemide, and NaCl (FR+FM+NaCl', 'Furosemide, Oral Sodium Chloride, and Fluid Restriction', 'furosemide with NaCl supplement', 'Furosemide', 'combined with fluid restriction, furosemide with or without sodium chloride (NaCl) supplementation', 'furosemide or water restriction with furosemide and salt supplementation']","['Acute kidney injury and hypokalemia\xa0(potassium≤3.0mmol/L', 'acute kidney injury and hypokalemia', 'Mean', 'change in [Na + ', 'percentage of patients or\xa0time to reach [Na + ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0021141', 'cui_str': 'Syndrome of Inappropriate ADH (SIADH) Secretion'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0204700', 'cui_str': 'Fluid restriction (procedure)'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0204700', 'cui_str': 'Fluid restriction (procedure)'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0020621', 'cui_str': 'Hypopotassemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",92.0,0.18245,There was no significant difference in percentage of patients or time to reach [Na + ] ≥ 130 or≥135mmol/L across the 3 groups.,"[{'ForeName': 'Pajaree', 'Initials': 'P', 'LastName': 'Krisanapan', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Surachet', 'Initials': 'S', 'LastName': 'Vongsanim', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Pathomporn', 'Initials': 'P', 'LastName': 'Pin-On', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; Pharmacoepidemiology and Statistics Research Center, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Chidchanok', 'Initials': 'C', 'LastName': 'Ruengorn', 'Affiliation': 'Department of Pharmaceutical Care, Chiang Mai University, Chiang Mai, Thailand; Pharmacoepidemiology and Statistics Research Center, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kajohnsak', 'Initials': 'K', 'LastName': 'Noppakun', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Chiang Mai University, Chiang Mai, Thailand; Pharmacoepidemiology and Statistics Research Center, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand. Electronic address: kajohnsak.noppakun@cmu.ac.th.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.11.012']
382,31679951,Augmented reality-based dance intervention for individuals with Parkinson's disease: A pilot study.,"BACKGROUND


The effects of dance on improving the symptoms of individuals with Parkinson's disease (PD) is well documented. Augmented reality devices, such as Google Glass, may be used to implement dance interventions to improve mobility and balance.
OBJECTIVE


To evaluate the feasibility, safety, and acceptability of a mobile dance intervention and obtain preliminary efficacy estimates for assessment of the research protocol.
METHODS


Seven participants with PD were asked to use Google Glass preloaded with Moving Through Dance modules for three weeks. Changes in motor functions (balance, mobility) and non-motor functions (mood, quality of life) were evaluated before and after completion of the intervention.
RESULTS


Recruitment rate was 50%, retention rate was 100%, and adherence to usage was 95%. The intervention was safe and accepted by participants. Use of Moving Through Glass improved mobility with a cognitive load (F(1, 5) = 10.76; p < 0.05). However, there were no significant changes to the participants' balance scores, quality of life or mood.
CONCLUSIONS


The outcomes of this pilot study suggest that Moving Through Glass, as a mobile dance intervention, may be a safe way to increase physical activity through dance in individuals with PD. Its efficacy should be investigated in a properly powered randomized controlled trial.",2020,"Use of Moving Through Glass improved mobility with a cognitive load (F(1, 5) = 10.76; p < 0.05).","[""individuals with Parkinson's disease (PD"", 'individuals with PD', ""individuals with Parkinson's disease"", 'Seven participants with PD']","['mobile dance intervention', 'Augmented reality-based dance intervention']","['feasibility, safety, and acceptability', 'mobility with a cognitive load', ""participants' balance scores, quality of life or mood"", 'motor functions (balance, mobility) and non-motor functions (mood, quality of life', 'retention rate']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",7.0,0.0757771,"Use of Moving Through Glass improved mobility with a cognitive load (F(1, 5) = 10.76; p < 0.05).","[{'ForeName': 'Tumay', 'Initials': 'T', 'LastName': 'Tunur', 'Affiliation': 'Department of Kinesiology, California State University San Marcos, San Marcos, CA, USA. Electronic address: ttunur@csusm.edu.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'DeBlois', 'Affiliation': 'Department of Physical Therapy Education, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Yates-Horton', 'Affiliation': 'Department of Physical Therapy Education, SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Rickford', 'Affiliation': 'Department of Exercise Science, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Columna', 'Affiliation': 'Department of Kinesiology, University of Wisconsin at Madison, Madison, WI, USA.'}]",Disability and health journal,['10.1016/j.dhjo.2019.100848']
383,32093451,[Clinical Effect of Day Surgery in Patients with Lung Caner by Optimize Operating Process].,"BACKGROUND


The types and number of day surgery are increasing, what is the result of day surgery of selected patients with lung cancer? To explore the operation process and clinical effect of day surgery in patients with lung cancer by fusing the concept of enhanced recovery after surgery (ERAS) and minimally invasive surgical techniques.
METHODS


A prospective study was planned with the approval of our institutional review board. 153 lung cancer patients who underwent anatomic resection in a single medical group between June 2019 and Nov 2019 were randomized. 20 patients were applied day surgery and 28 patients by inpatient surgery and the average length of stay, average hospital cost , complications and adverse reactions were analysed.
RESULTS


The average hospital day in DSG group (1 d) was significantly shorter than in ISG group (7.7±2.8) d (P=0.000). The average hospital cost in DSG group (38,297.3±3,408.7)¥ was significantly lower than in ISG group (47,831.1±7,376.1)¥ (P=0.000). There was no significant difference in the incidence of postoperative complications between the daytime surgery group (5.0%) and the inpatient surgery group (3.6%) (P=0.812). The postoperation adverse reactions in DSG (10.0%) and ISG (17.9%) is no difference (P=0.72).
CONCLUSIONS


Our study showed that the same clinical effect achieved between DSG and ISG, and recover quickly lung cancer patients after day surgery.",2020,There was no significant difference in the incidence of postoperative complications between the daytime surgery group (5.0%) and the inpatient surgery group (3.6%) (P=0.812).,"['Patients with Lung Caner by Optimize Operating Process', '153 lung cancer patients who underwent anatomic resection in a single medical group between June 2019 and Nov 2019 were randomized', 'patients with lung cancer by fusing the concept of enhanced recovery after surgery (ERAS) and minimally invasive surgical techniques', '20 patients were applied day surgery and 28 patients by inpatient surgery and the']",['Day Surgery'],"['average length of stay, average hospital cost , complications and adverse reactions', 'postoperation adverse reactions', 'incidence of postoperative complications', 'average hospital cost']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0282046', 'cui_str': 'Surgery, Day'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0282046', 'cui_str': 'Surgery, Day'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",153.0,0.0270336,There was no significant difference in the incidence of postoperative complications between the daytime surgery group (5.0%) and the inpatient surgery group (3.6%) (P=0.812).,"[{'ForeName': 'Yingxian', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Daojun', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Che', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Lunxu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Hongsheng', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Day Surgery Center, West China Hospital, Sichuan University, Chengdu 610041, China.'}]",Zhongguo fei ai za zhi = Chinese journal of lung cancer,['10.3779/j.issn.1009-3419.2020.02.02']
384,32180150,Clinical Experience in Treatment of Alzheimer's Disease with Jiannao Yizhi Formula () and Routine Western Medicine.,"OBJECTIVE


To investigate the long-term therapeutic effects of the Chinese medicine Jiannao Yizhi Formula (, JYF) in the treatment of Alzheimer's disease (AD).
METHODS


Sixty mild-to-moderate AD participants were recruited and randomly allocated to the treatment (30 with JYF) and the control groups (30 with donepezil) for 6 months with the random numbers. The primary outcomes were scores of Alzheimer's Disease Rating Scale-Cognitive (ADAS-Cog) and Chinese Medicine Symptom Scale (CM-SS). The secondary outcomes were scores of Mini Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Activities of Daily Living (ADL). Safety assessments were conducted at baseline and the 6th month of treatment. Serum levels of acetylcholine (Ach), amyloid-β protein 42 (Aβ 42 ), and the microtubule-associated protein tau (Tau) were also determined by enzyme-liked immunosorbent assay.
RESULTS


Fifty-one participants were included in the final analyses (JYF n=27; donepezil n=24). Compared with baseline, both JYF and donepezil increased the MoCA and MMSE scores and decreased the ADAS-Cog and CM-SS scores (P<0.05 or P<0.01). Both drugs increased the serum levels of Ach and decreased the serum levels of Aβ 42  and Tau (all P<0.05). There was no significant difference in these variables between the two groups, which showed that JYF was not inferior to donepezil. No obviously significant changes were observed in the ADL. No severe adverse events were observed in both groups.
CONCLUSION


The effect and safety of JYF for the treatment of AD were not inferior to those of donepezil.",2020,Both drugs increased the serum levels of Ach and decreased the serum levels of Aβ 42  and Tau (all P<0.05).,"[""Alzheimer's Disease with Jiannao Yizhi Formula () and Routine Western Medicine"", ""Alzheimer's disease (AD"", 'Fifty-one participants were included in the final analyses (JYF n=27; donepezil n=24', 'Sixty mild-to-moderate AD participants']","['donepezil', 'JYF', 'Chinese medicine Jiannao Yizhi Formula (, JYF', 'JYF and donepezil']","['ADL', 'MoCA and MMSE scores', 'ADAS-Cog and CM-SS scores', 'severe adverse events', 'scores of Mini Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Activities of Daily Living (ADL', ""scores of Alzheimer's Disease Rating Scale-Cognitive (ADAS-Cog) and Chinese Medicine Symptom Scale (CM-SS"", 'Serum levels of acetylcholine (Ach), amyloid-β protein 42 (Aβ 42 ), and the microtubule-associated protein tau (Tau']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1869287', 'cui_str': 'yizhi'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C1869287', 'cui_str': 'yizhi'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3496286'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0222045'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0026046', 'cui_str': 'Microtubules'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]",51.0,0.0838283,Both drugs increased the serum levels of Ach and decreased the serum levels of Aβ 42  and Tau (all P<0.05).,"[{'ForeName': 'Hui-Chan', 'Initials': 'HC', 'LastName': 'Wang', 'Affiliation': 'Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Nan-Yang', 'Initials': 'NY', 'LastName': 'Liu', 'Affiliation': 'Department of Geratology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Geratology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Geratology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Wang', 'Affiliation': 'Department of Geratology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Geratology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Jian-Gang', 'Initials': 'JG', 'LastName': 'Liu', 'Affiliation': 'Department of Geratology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Pei', 'Affiliation': 'Department of Geratology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Geratology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. xyhplihao1965@126.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-019-2718-2']
385,32074953,Endurance Training vs. Circuit Resistance Training: Effects on Lipid Profile and Anthropometric/Body Composition Status in Healthy Young Adult Women.,"BACKGROUND


Endurance training (ET) and resistance training (RT) are known to be effective in improving anthropometric/body composition and lipid panel indicators, but there is an evident lack of studies on differential effects of these two forms of physical exercise (PE). This study aimed to evaluate the differential effects of 8-week ET and RT among young adult women.
METHODS


Participants were women ( n  = 57; age: 23 ± 3 years; initial body height: 165 ± 6 cm; body mass: 66.79 ± 7.23 kg; BMI: 24.37 ± 2.57 kg/m 2 ) divided into the ET group ( n  = 20), RT group ( n  = 19), and non-exercising control group ( n  = 18). All participants were tested for cardiovascular risk factors (CRF), including total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, glucose, and anthropometric/body composition (body mass, body mass index, skinfold measures, body fat %) at the beginning and at the end of the study. Over the 8 weeks, the ET group trained three times/week on a treadmill while the RT group participated in equal number of circuit weight training sessions. Both types of training were planned according to participants' pre-study fitness status.
RESULTS


A two-factor analysis of variance for repeated measurements (""group"" × ""measurement"") revealed significant main effects for ""measurement"" in CRF. The ""group x measurement"" interaction was significant for CRF. The post-hoc analysis indicated significant improvements in CRF for RT and ET. No significant differential effects between RT and ET were evidenced.
CONCLUSIONS


The results of this study evidence improvements of CRF in young adult women as a result of 8-week ET and RT. The lack of differential training-effects may be attributed to the fact that all participants underwent pre-study screening of their fitness status, which resulted in application of accurate training loads.",2020,"No significant differential effects between RT and ET were evidenced.
","['young adult women', 'Participants were women ( n  = 57; age: 23 ± 3 years; initial body height: 165 ± 6 cm; body mass: 66.79 ± 7.23 kg; BMI: 24.37 ± 2.57 kg/m 2 ) divided into the ET group ( n  = 20), RT group ( n  = 19), and non-exercising control group ( n  = 18', 'Healthy Young Adult Women']","['Endurance Training vs. Circuit Resistance Training', 'Endurance training (ET) and resistance training (RT']","['CRF', 'Lipid Profile and Anthropometric/Body Composition Status', 'cardiovascular risk factors (CRF), including total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, glucose, and anthropometric/body composition (body mass, body mass index, skinfold measures, body fat ']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0005890', 'cui_str': 'Body Height'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",,0.0197928,"No significant differential effects between RT and ET were evidenced.
","[{'ForeName': 'Gentiana', 'Initials': 'G', 'LastName': 'Beqa Ahmeti', 'Affiliation': 'Faculty of Physical Education and Sport, University of Prishtina, 10000 Prishtina, Kosovo.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Idrizovic', 'Affiliation': 'Faculty for Sport and Physical Education, University of Montenegro, 81400 Niksic, Montenegro.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Elezi', 'Affiliation': 'Faculty of Physical Education and Sport, University of Prishtina, 10000 Prishtina, Kosovo.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Zenic', 'Affiliation': 'Faculty of Kinesiology, University of Split, 21000 Split, Croatia.'}, {'ForeName': 'Ljerka', 'Initials': 'L', 'LastName': 'Ostojic', 'Affiliation': 'Faculty of Kinesiology, University of Split, 21000 Split, Croatia.'}]",International journal of environmental research and public health,['10.3390/ijerph17041222']
386,32130116,Dose-Response Effect of a Digital Health Intervention During Cardiac Rehabilitation: Subanalysis of Randomized Controlled Trial.,"BACKGROUND


Previous data have validated the benefit of digital health interventions (DHIs) on weight loss in patients following acute coronary syndrome entering cardiac rehabilitation (CR).
OBJECTIVE


The primary purpose of this study was to test the hypothesis that increased DHI use, as measured by individual log-ins, is associated with improved weight loss. Secondary analyses evaluated the association between log-ins and activity within the platform and exercise, dietary, and medication adherence.
METHODS


We obtained DHI data including active days, total log-ins, tasks completed, educational modules reviewed, medication adherence, and nonmonetary incentive points earned in patients undergoing standard CR following acute coronary syndrome. Linear regression followed by multivariable models were used to evaluate associations between DHI log-ins and weight loss or dietary adherence.
RESULTS


Participants (n=61) were 79% male (48/61) with mean age of 61.0 (SD 9.7) years. We found a significant positive association of total log-ins during CR with weight loss (r 2 =.10, P=.03). Educational modules viewed (r 2 =.11, P=.009) and tasks completed (r 2 =.10, P=.01) were positively significantly associated with weight loss, yet total log-ins were not significantly associated with differences in dietary adherence (r 2 =.05, P=.12) or improvements in minutes of exercise per week (r 2 =.03, P=.36).
CONCLUSIONS


These data extend our previous findings and demonstrate increased DHI log-ins portend improved weight loss in patients undergoing CR after acute coronary syndrome. DHI adherence can potentially be monitored and used as a tool to selectively encourage patients to adhere to secondary prevention lifestyle modifications.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT01883050); https://clinicaltrials.gov/ct2/show/NCT01883050.",2020,"Educational modules viewed (r 2 =.11, P=.009) and tasks completed (r 2 =.10, P=.01) were positively significantly associated with weight loss, yet total log-ins were not significantly associated with differences in dietary adherence (r 2 =.05, P=.12) or improvements in minutes of exercise per week (r 2 =.03, P=.36).
","['patients following acute coronary syndrome entering cardiac rehabilitation (CR', 'patients undergoing CR after acute coronary syndrome', 'Participants (n=61) were 79% male (48/61) with mean age of 61.0 (SD 9.7) years']","['digital health interventions (DHIs', 'Digital Health Intervention']","['weight loss', 'dietary adherence', 'association between log-ins and activity within the platform and exercise, dietary, and medication adherence', 'DHI log-ins and weight loss or dietary adherence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",79.0,0.149347,"Educational modules viewed (r 2 =.11, P=.009) and tasks completed (r 2 =.10, P=.01) were positively significantly associated with weight loss, yet total log-ins were not significantly associated with differences in dietary adherence (r 2 =.05, P=.12) or improvements in minutes of exercise per week (r 2 =.03, P=.36).
","[{'ForeName': 'R Jay', 'Initials': 'RJ', 'LastName': 'Widmer', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Senecal', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Allison', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lopez-Jimenez', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Lilach O', 'Initials': 'LO', 'LastName': 'Lerman', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Lerman', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States.'}]",Journal of medical Internet research,['10.2196/13055']
387,32044089,Embryo's Natural Motion (enMotion): a paired randomized controlled trial evaluating a dynamic embryo culture system.,"OBJECTIVE


To determine if a dynamic embryo culture system affects the reproductive potential of human embryos resulting from in vitro fertilization (IVF).
DESIGN


Paired randomized controlled trial (RCT).
SETTING


IVF center.
PATIENT(S)


IVF patients with normal ovarian reserve eligible for two-embryo transfer.
INTERVENTION


IVF care was routine until fertilization was confirmed. Two-pronuclear embryos (2PNs) were then randomized: One-half of each patient's 2PNs were cultured in dynamic culture and one-half in static culture. Preimplantation genetic testing for embryonic aneuploidy was used to control for aneuploidy and allow for DNA fingerprinting. The best euploid blastocyst from each culture system was selected and patients underwent a frozen two-embryo transfer. If a singleton gestation resulted, DNA-fingerprinting was used to determine which of the two blastocysts implanted. The dynamic platform used was the NSSB-300 (Nepagene).
MAIN OUTCOME MEASURE(S)


The primary outcome was the proportion of usable blastocysts obtained. The secondary outcome was sustained implantation rate (SIR).
RESULT(S)


One hundred participants completed oocyte retrieval and blastocyst vitrification for frozen-thawed embryo transfer; 609 dynamic 2PNs and 615 static 2PNs were followed; and 304 blastocysts developed in dynamic culture and 333 blastocysts developed in static culture. In the paired analysis, the rate of usable blastulation was similar between dynamic and static culture (58.3% vs. 57.1%). In addition, there was no difference in the rate of aneuploidy (20.0% vs. 33.3%) or SIR (67.1% vs. 63.1%) between groups.
CONCLUSION(S)


In this paired RCT, dynamic culture did not improve usable blastulation rate or SIR.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02467725.",2020,Preimplantation genetic testing for embryonic aneuploidy was used to control for aneuploidy and allow for DNA fingerprinting.,"['One hundred participants completed oocyte retrieval and blastocyst vitrification for frozen-thawed embryo transfer; 609 dynamic 2PNs and 615 static 2PNs were followed; and 304 blastocysts developed in dynamic culture and 333 blastocysts developed in static culture', '\n\n\nIVF patients with normal ovarian reserve eligible for two-embryo transfer', 'IVF center', 'human embryos resulting from in\xa0vitro fertilization (IVF']","[""Embryo's Natural Motion (enMotion""]","['proportion of usable blastocysts obtained', 'rate of usable blastulation', 'rate of aneuploidy', 'sustained implantation rate (SIR', 'usable blastulation rate or SIR']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0404268', 'cui_str': 'Oocyte Collection'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C2936610', 'cui_str': 'Glass-Liquid Transition'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}]","[{'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0002938', 'cui_str': 'Aneuploid'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}]",100.0,0.244667,Preimplantation genetic testing for embryonic aneuploidy was used to control for aneuploidy and allow for DNA fingerprinting.,"[{'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Juneau', 'Affiliation': 'Audubon Fertility, New Orleans, Louisiana.'}, {'ForeName': 'Ashley W', 'Initials': 'AW', 'LastName': 'Tiegs', 'Affiliation': 'Reproductive Medicine Associates of New Jersey, Basking Ridge, New Jersey.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Franasiak', 'Affiliation': 'Reproductive Medicine Associates of New Jersey, Basking Ridge, New Jersey; Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Linnea R', 'Initials': 'LR', 'LastName': 'Goodman', 'Affiliation': 'UNC Fertility, Raleigh, North Carolina. Electronic address: linnea.goodman@gmail.com.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Whitehead', 'Affiliation': 'Reproductive Medicine Associates of New Jersey, Basking Ridge, New Jersey.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Patounakis', 'Affiliation': 'Reproductive Medicine Associates of Florida, Lake Mary, Florida.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Scott', 'Affiliation': 'Reproductive Medicine Associates of New Jersey, Basking Ridge, New Jersey; Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.09.043']
388,32044750,Impact of a Knowledge Translation Intervention on Physical Activity and Mobility in Older Adults (the Move4Age Study): Randomized Controlled Trial.,"BACKGROUND


The McMaster Optimal Aging Portal (the Portal) was launched in 2014 as a knowledge translation (KT) tool to increase access to evidence-based health information.
OBJECTIVE


The purpose of this study was to understand if and how dissemination of mobility information through the Portal impacts physical activity (PA) in older adults.
METHODS


In this randomized controlled trial, participants (n=510) were assigned to a 12-week mobility-focused KT intervention or self-serve control group. The intervention included weekly email alerts and a study-specific social media hashtag linking to mobility-focused Portal materials. The control group was able to access the Portal on their own but did not receive targeted KT strategies. Participants completed questionnaires (including the Rapid Assessment of Physical Activity to quantify PA) at baseline, end of the study, and 3-month follow-up.
RESULTS


Participants were predominantly female (430/510, 84.3%), mean age 64.7 years, with no baseline differences between groups. Over half (277/510, 54.3%) of the participants were classified as ""active"" at baseline. There was no significant between-group difference in the PA category. Overall, both groups increased their PA with improvements maintained at 3-month follow-up (P<.001). In planned subgroup analyses, the KT intervention had a significant effect for those with poor or fair baseline self-rated health (P=.03).
CONCLUSIONS


No differences were found between those who received the targeted intervention and a control group with self-serve access to the Portal, except in subgroups with low self-rated health. Both groups did report increases in PA that were sustained beyond participation in a research study. Findings suggest that different KT strategies may be needed for different types of users, with more intense interventions being most impactful for certain groups (ie, those with lower self-rated health).
TRIAL REGISTRATION


ClinicalTrials.gov NCT02947230; https://clinicaltrials.gov/ct2/show/NCT02947230.",2020,"No differences were found between those who received the targeted intervention and a control group with self-serve access to the Portal, except in subgroups with low self-rated health.","['Participants were predominantly female (430/510, 84.3%), mean age 64.7 years', 'older adults', 'Older Adults (the Move4Age Study', 'participants (n=510']","['weekly email alerts and a study-specific social media hashtag linking to mobility-focused Portal materials', 'Knowledge Translation Intervention', 'KT intervention', 'mobility-focused KT intervention or self-serve control group']","['Physical Activity and Mobility', 'poor or fair baseline self-rated health']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C3494164', 'cui_str': 'Knowledge Translation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",510.0,0.0915012,"No differences were found between those who received the targeted intervention and a control group with self-serve access to the Portal, except in subgroups with low self-rated health.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Neil-Sztramko', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Smith-Turchyn', 'Affiliation': 'Faculty of Kinesiology & Physical Education, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Richardson', 'Affiliation': 'School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Dobbins', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, ON, Canada.'}]",Journal of medical Internet research,['10.2196/15125']
389,32092918,The Effects of Low-Energy Moderate-Carbohydrate (MCD) and Mixed (MixD) Diets on Serum Lipid Profiles and Body Composition in Middle-Aged Men: A Randomized Controlled Parallel-Group Clinical Trial.,"Carbohydrate-restricted diets have become very popular due to their numerous health benefits. The aim of this study was to determine the influence of 4 weeks of a well-planned, low-energy moderate-carbohydrate diet (MCD) and a low-energy mixed diet (MixD) on the lipoprotein profile, glucose and C-reactive protein concentrations, body mass, and body composition in middle-aged males. Sixty middle-aged males were randomly assigned to the following groups: hypocaloric MCD (32% carbohydrates, 28% proteins, and 40% fat), hypocaloric MixD (50% carbohydrates, 20% proteins, and 30% fat), and a conventional (control) diet (CD; 48% carbohydrates, 15% proteins, and 37% fat). The participants who were classified into the MCD and MixD groups consumed 20% fewer calories daily than the total daily energy expenditure (TDEE). Baseline and postintervention fasting triacylglycerol (TG), LDL (low-density lipoprotein) cholesterol (LDL-C), HDL (high-density lipoprotein) cholesterol (HDL-C), total cholesterol (tCh), glucose (Gl), and C-reactive protein were evaluated. Body mass (BM) and body composition changes, including body fat (BF), % body fat (PBF), and muscle mass (MM), were monitored. Compared with MixD and CD, MCD significantly changed the fasting serum concentrations of TG ( p  < 0.05), HDL-C ( p  < 0.05), LDL-C ( p  < 0.05), tCh ( p  < 0.05), and glucose ( p  < 0.01). Additionally, body fat content (kg and %) was significantly reduced ( p  < 0.05) after MCD compared with MixD and CD. After the MixD intervention, BM and MM decreased ( p  < 0.05) compared with baseline values. Compared with baseline, after the MixD, BM, MM, tCh, LDL-C, and TG changed significantly. The 4 week low-energy MCD intervention changed lipoproteins, glucose, and body fat to a greater extent than the low-energy MixD. A hypocaloric MCD may be suggested for middle-aged male subjects who want to lose weight by reducing body fat content without compromising muscle mass.",2020,"Compared with MixD and CD, MCD significantly changed the fasting serum concentrations of TG ( p  < 0.05), HDL-C ( p  < 0.05), LDL-C ( p  < 0.05), tCh ( p  < 0.05), and glucose ( p  < 0.01).","['middle-aged male subjects', 'Sixty middle-aged males', 'middle-aged males', 'Middle-Aged Men']","['hypocaloric MCD (32% carbohydrates, 28% proteins, and 40% fat), hypocaloric MixD (50% carbohydrates, 20% proteins, and 30% fat), and a conventional (control) diet', 'Low-Energy Moderate-Carbohydrate (MCD) and Mixed (MixD', 'well-planned, low-energy moderate-carbohydrate diet (MCD) and a low-energy mixed diet (MixD', 'hypocaloric MCD', 'Diets', 'Carbohydrate-restricted diets']","['Serum Lipid Profiles and Body Composition', 'lipoproteins, glucose, and body fat to a greater extent than the low-energy MixD', 'Baseline and postintervention fasting triacylglycerol (TG), LDL (low-density lipoprotein) cholesterol (LDL-C), HDL (high-density lipoprotein) cholesterol (HDL-C), total cholesterol (tCh), glucose (Gl), and C-reactive protein', 'body fat content', 'total daily energy expenditure (TDEE', 'LDL-C', 'fasting serum concentrations of TG', 'BM and MM', 'lipoprotein profile, glucose and C-reactive protein concentrations, body mass, and body composition', 'HDL-C', 'Body mass (BM) and body composition changes, including body fat (BF), % body fat (PBF), and muscle mass (MM']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1636149', 'cui_str': 'Mcd'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet (finding)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}]",60.0,0.0250488,"Compared with MixD and CD, MCD significantly changed the fasting serum concentrations of TG ( p  < 0.05), HDL-C ( p  < 0.05), LDL-C ( p  < 0.05), tCh ( p  < 0.05), and glucose ( p  < 0.01).","[{'ForeName': 'Małgorzata Magdalena', 'Initials': 'MM', 'LastName': 'Michalczyk', 'Affiliation': 'Institute of Sport Science, The Jerzy Kukuczka Academy of Physical Education, 40-065 Katowice, Mikolowska 72a, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Maszczyk', 'Affiliation': 'Institute of Sport Science, The Jerzy Kukuczka Academy of Physical Education, 40-065 Katowice, Mikolowska 72a, Poland.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Stastny', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University in Prague, 162 52 Prague, Czech Republic.'}]",International journal of environmental research and public health,['10.3390/ijerph17041332']
390,31414860,Opioids and social bonding: Effect of naltrexone on feelings of social connection and ventral striatum activity to close others.,"Close social bonds are critical to immediate and long-term well-being. However, the neurochemical mechanisms by which we remain connected to our closest loved ones are not well understood. Opioids have long been theorized to contribute to social bonding via their actions on the brain. But feelings of social connection toward one's own close others and direct comparisons of ventral striatum (VS) activity in response to close others and strangers, a neural correlate of social bonding, have not been explored. Therefore, the current clinical trial examined whether opioids causally affect neural and experiential signatures of social bonding. Eighty participants were administered naltrexone (n = 40), an opioid antagonist that blocks natural opioid processing, or placebo (n = 40) before completing a functional MRI scan where they viewed images of their close others and individuals they had not seen before (i.e., strangers). Feelings of social connection to the close others and physical symptoms commonly experienced when taking naltrexone were also collected. In support of hypotheses, naltrexone (vs. placebo) reduced feelings of social connection toward the close others (e.g., family, friends, romantic partners). Furthermore, naltrexone (vs. placebo) reduced left VS activity in response to images of the same close others, but did not alter left VS activity to strangers. Finally, the positive correlation between feelings of connection and VS activity to close others present in the placebo condition was erased by naltrexone. Effects remained after adjusting for physical symptoms. Together, results lend support to theories suggesting that opioids contribute to social bonding, especially with our closest loved ones. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"In support of hypotheses, naltrexone (vs. placebo) reduced feelings of social connection toward the close others (e.g., family, friends, romantic partners).",['Eighty participants were administered'],"['naltrexone (vs. placebo', 'opioid antagonist that blocks natural opioid processing, or placebo', 'naltrexone']","['feelings of social connection', 'feelings of connection and VS activity', 'left VS activity', 'feelings of social connection and ventral striatum activity']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",80.0,0.0291777,"In support of hypotheses, naltrexone (vs. placebo) reduced feelings of social connection toward the close others (e.g., family, friends, romantic partners).","[{'ForeName': 'Tristen K', 'Initials': 'TK', 'LastName': 'Inagaki', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Laura I', 'Initials': 'LI', 'LastName': 'Hazlett', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Andreescu', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine.'}]",Journal of experimental psychology. General,['10.1037/xge0000674']
391,32192592,Physical activity and incidence of subclinical and clinical pregnancy loss: a secondary analysis in the effects of aspirin in gestation and reproduction randomized trial.,"OBJECTIVE


To estimate the association between physical activity and risk of subclinical and clinical pregnancy loss among women with a history of pregnancy loss.
DESIGN


Prospective cohort study as a secondary analysis of the Effects of Aspirin in Gestation and Reproduction randomized controlled trial of preconception-initiated low-dose aspirin among women with one or two prior pregnancy losses.
SETTING


Four U.S. clinical centers, 2007-2011.
PATIENT(S)


Women with confirmed pregnancy (n = 785) as determined from hCG testing in longitudinally collected biospecimens.
MAIN OUTCOME MEASURE(S)


Subclinical loss of pregnancy detected only by hCG testing and clinically recognized loss.
RESULT(S)


Among 785 women (mean [SD] age, 28.7 [4.6] years) with an hCG-confirmed pregnancy, 188 (23.9%) experienced pregnancy loss. In multivariable models adjusted for confounders, compared with the first tertile of physical activity (median = 7.7 metabolic equivalent of task hours/week), there was a roughly twofold higher risk of subclinical loss in the second (risk ratio = 2.06; 95% confidence interval, 1.03-4.14) and third tertiles (risk ratio = 1.92; 95% confidence interval, 0.94-3.90), with median metabolic equivalent of task hours/week of 27.8 and 95.7, respectively. No relations were observed between physical activity and clinically recognized loss.
CONCLUSION(S)


Risk related to physical activity is different for pregnancy failure close to the time of implantation compared with that for later, clinical pregnancy loss. Higher physical activity levels were associated with an elevated risk of subclinical loss (i.e., pregnancies detected only by hCG, n = 55); however, no relationship was observed with clinically recognized loss. Further work is required to confirm these findings, assess generalizability to women without prior losses, and evaluate mechanisms.
ETHICAL APPROVAL


Each participating center's Institutional Review Board approved the study, and participants provided written informed consent. The trial was registered on ClinicalTrials.gov (NCT00467363), and a Data Safety and Monitoring Board provided oversight.",2020,"No relations were observed between physical activity and clinically recognized loss.
","['women with a history of pregnancy loss', '785 women (mean [SD] age, 28.7 [4.6] years) with an hCG-confirmed pregnancy, 188 (23.9%) experienced pregnancy loss', 'women with one or two prior pregnancy losses', '\n\n\nWomen with confirmed pregnancy (n = 785) as determined from hCG testing in longitudinally collected biospecimens', 'Four U.S. clinical centers, 2007-2011']","['preconception-initiated low-dose aspirin', 'aspirin', 'Aspirin']","['physical activity and clinically recognized loss', 'physical activity', 'Subclinical loss of pregnancy', 'elevated risk of subclinical loss', 'Higher physical activity levels', 'Physical activity and incidence of subclinical and clinical pregnancy loss', 'subclinical loss']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032967', 'cui_str': 'Pregnancy History'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}]",,0.212126,"No relations were observed between physical activity and clinically recognized loss.
","[{'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Russo', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Massachusetts Amherst, Amherst, Massachusetts.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Whitcomb', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Massachusetts Amherst, Amherst, Massachusetts. Electronic address: bwhitcom@umass.edu.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Freeman', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Massachusetts Amherst, Amherst, Massachusetts; Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Schliep', 'Affiliation': 'Department of Family and Preventive Medicine, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Jagteshwar', 'Initials': 'J', 'LastName': 'Grewal', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, Utah.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.10.027']
392,32130142,Online Self-Management Support for Family Caregivers Dealing With Behavior Changes in Relatives With Dementia (Part 2): Randomized Controlled Trial.,"BACKGROUND


Online contacts with a health professional have the potential to support family caregivers of people with dementia.
OBJECTIVE


The goal of the research was to study the effects of an online self-management support intervention in helping family caregivers deal with behavior changes of a relative with dementia. The intervention-involving among others personal email contacts with a dementia nurse-was compared with online interventions without these email contacts.
METHODS


A randomized controlled trial was conducted with 81 family caregivers of people with dementia who live at home. Participants were randomly assigned to a (1) major self-management support intervention consisting of personal email contacts with a specialist dementia nurse, online videos, and e-bulletins; (2) medium intervention consisting only of online videos and e-bulletins; or (3) minor intervention consisting of only the e-bulletins. The primary outcome was family caregivers' self-efficacy in dealing with behavior changes of the relative with dementia. Secondary outcomes were family caregivers' reports of behavior problems in the people with dementia and the quality of the relationship between the family caregiver and the person with dementia. Measurements were performed at the baseline and at 6 (T1) and 12 weeks (T2) after the baseline. A mixed-model analysis was conducted to compare the outcomes of the 3 intervention arms.
RESULTS


Family caregivers participating in the major intervention involving email contacts showed no statistically significant differences in self-efficacy after the intervention compared with the minor intervention involving only e-bulletins (difference -0.02, P=.99). In the adjusted analysis, the medium intervention (involving videos and e-bulletins) showed a negative trend over time (difference -4.21, P=.09) and at T1 (difference -4.71, P=.07) compared with the minor intervention involving only e-bulletins. No statistical differences were found between the intervention arms in terms of the reported behavior problems and the quality of the relationship between the family caregiver and the person with dementia.
CONCLUSIONS


The expectation that an online self-management support intervention involving email contacts would lead to positive effects and be more effective than online interventions without personal email contacts was not borne out. One explanation might be related to the fact that not all family caregivers who were assigned to that intervention actually made use of the opportunity for personal email contact. The online videos were also not always viewed. To obtain more definite conclusions, future research involving extra efforts to reach higher use rates is required.
TRIAL REGISTRATION


Netherlands Trial Registry NTR6237; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6237 (Archived by WebCite at http://www.webcitation.org/6v0S4fxTC).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/resprot.8365.",2020,"RESULTS


Family caregivers participating in the major intervention involving email contacts showed no statistically significant differences in self-efficacy after the intervention compared with the minor intervention involving only e-bulletins (difference -0.02, P=.99).","['Family Caregivers', '81 family caregivers of people with dementia who live at home', 'Relatives With Dementia (Part 2']","['online self-management support intervention', 'major self-management support intervention consisting of personal email contacts with a specialist dementia nurse, online videos, and e-bulletins; (2) medium intervention consisting only of online videos and e-bulletins; or (3) minor intervention consisting of only the e-bulletins']","[""family caregivers' self-efficacy in dealing with behavior changes of the relative with dementia"", 'self-efficacy', ""family caregivers' reports of behavior problems in the people with dementia and the quality of the relationship between the family caregiver and the person with dementia""]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]",81.0,0.115156,"RESULTS


Family caregivers participating in the major intervention involving email contacts showed no statistically significant differences in self-efficacy after the intervention compared with the minor intervention involving only e-bulletins (difference -0.02, P=.99).","[{'ForeName': 'Judith G', 'Initials': 'JG', 'LastName': 'Huis In Het Veld', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam University Medical Center, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Bernadette M', 'Initials': 'BM', 'LastName': 'Willemse', 'Affiliation': 'Netherlands Institute of Mental Health and Addiction, Trimbos Institute, Utrecht, Netherlands.'}, {'ForeName': 'Iris Fm', 'Initials': 'IF', 'LastName': 'van Asch', 'Affiliation': 'Netherlands Institute of Mental Health and Addiction, Trimbos Institute, Utrecht, Netherlands.'}, {'ForeName': 'Rob Bm', 'Initials': 'RB', 'LastName': 'Groot Zwaaftink', 'Affiliation': ""Dutch Alzheimer's Society, Amersfoort, Netherlands.""}, {'ForeName': 'Paul-Jeroen', 'Initials': 'PJ', 'LastName': 'Verkade', 'Affiliation': 'The Geriant Foundation, Region North of Amsterdam, Netherlands.'}, {'ForeName': 'Jos Wr', 'Initials': 'JW', 'LastName': 'Twisk', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Amsterdam University Medical Center, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Verkaik', 'Affiliation': 'Netherlands Institute for Health Services Research, Utrecht, Netherlands.'}, {'ForeName': 'Marco M', 'Initials': 'MM', 'LastName': 'Blom', 'Affiliation': ""Dutch Alzheimer's Society, Amersfoort, Netherlands.""}, {'ForeName': 'Berno', 'Initials': 'B', 'LastName': 'van Meijel', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Anneke L', 'Initials': 'AL', 'LastName': 'Francke', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam University Medical Center, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/13001']
393,32192739,Reply to Comment on: Conbercept for Treatment of Neovascular Age-Related Macular Degeneration: Results of the Randomized Phase 3 PHOENIX Study.,,2020,,['Neovascular Age-Related Macular Degeneration'],['Conbercept'],[],"[{'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}]",[],,0.0180722,,"[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Shanghai, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Shanghai, China.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Kaiser', 'Affiliation': 'Cleveland, Ohio.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Rosenfeld', 'Affiliation': 'Miami, Florida.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Boston, Massachusetts.'}]",American journal of ophthalmology,['10.1016/j.ajo.2019.12.007']
394,32053937,Older Adults' Perceptions of the Usefulness of Technologies for Engaging in Physical Activity: Using Focus Groups to Explore Physical Literacy.,"Insufficient physical activity (PA) levels observed among older adults remain extremely high and pose a danger to developing and maintaining their physical literacy (PL). Each person's level of PL partly depends on their physical and cognitive skills, confidence level, and degree of motivation to practice PA daily. New technologies, such as exergames and wearable fitness trackers, may enable older adults to increase their PL, stimulating uptake and ongoing PA participation.  Objective : This focus group study aims to describe older adults' perceptions of the use of technologies to engage in physical exercise programs.  Methods : Fifteen participants were randomly selected from a sample of 40 older adults who completed a randomized controlled trial that investigated the benefits of using technology in the context of group-based exercise programs. Separate post-intervention focus groups were performed with an exergaming group, a conventional physical training group, and a no training group (control). Data were mapped onto constructs from the four domains of PL: affective, physical, cognitive, and behavioral.  Results : Generally, participants expressed positive perceptions about the benefits of using technology to engage in PA. These positive feelings outweighed the costs and the lack of familiarization with technology. Common themes for the three groups emerged from the discussions and included familiarization with technology, using fitness tracker to monitor PA, previous exposure to technology, and interaction with peers, staff members, and relatives. In particular, participants from the exergaming group explored the ideas of training their cognitive skills while using the exergame accessories, exercising in an alternative way, competitive versus cooperative play, changes in sense of humor, skill transferability from game to real environment, progressions of the exercise intensities, and the potential use of exergames for rehabilitation.  Conclusions : Participants in this study reported positive perceptions about implementing technology into exercise. Emphasizing the benefits of using technology in group-based exercise programs may increase older adults' PL levels and their future technology adoption. The potential implementation of technology into conventional exercise programs should focus on older adults' lifelong values, biopsychosocial conditions, and the possibility of reducing age-related risk of injuries and chronic diseases.",2020,"Common themes for the three groups emerged from the discussions and included familiarization with technology, using fitness tracker to monitor PA, previous exposure to technology, and interaction with peers, staff members, and relatives.","[""older adults' perceptions"", 'older adults', ""Older Adults' Perceptions"", 'Fifteen participants were randomly selected from a sample of 40 older adults']","['conventional exercise programs', 'technology in the context of group-based exercise programs', 'conventional physical training group, and a no training group (control', 'physical exercise programs']","['Insufficient physical activity (PA) levels', ""older adults' PL levels""]","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",40.0,0.0258626,"Common themes for the three groups emerged from the discussions and included familiarization with technology, using fitness tracker to monitor PA, previous exposure to technology, and interaction with peers, staff members, and relatives.","[{'ForeName': 'Alexandre Monte', 'Initials': 'AM', 'LastName': 'Campelo', 'Affiliation': 'Sport Technology Research Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Katz', 'Affiliation': 'Sport Technology Research Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17041144']
395,31808131,"Medical Scribes, Provider and Patient Experience, and Patient Throughput: a Trial in an Academic General Internal Medicine Practice.","BACKGROUND


Medical scribes have been proposed as a solution to the problems of excessive documentation, work-life balance, and burnout facing general internists. However, their acceptability to patients and effects on provider experience have not been tested in a real-world model of effectiveness.
OBJECTIVE


To measure the effect of medical scribes on patient satisfaction, provider satisfaction, and provider productivity.
DESIGN


Quasi-experimental difference-in-differences longitudinal design.
PARTICIPANTS


Four attending physicians who worked with scribes, 9 control physicians who did not, and their patients in a large, hospital-affiliated academic general internal medicine practice.
MAIN MEASURES


Provider experience and patient experience using 5-point Likert scale surveys from the AMA Steps Forward Team Documentation Module, and visits and wRVUs per hour during 4 weeks before and 12 weeks after initiation of a practice model that included use of scribes and a shortened visit template.
KEY RESULTS


Participating providers worked a total of 664 clinic sessions and returned 547 (82%) surveys. Average provider experience scores did not differ between providers working with scribes and control providers working without (4.01 vs. 3.40 respectively; p time-by-group interaction = 0.26). Providers with scribes were more likely to agree that work for the encounter would be completed during the visit then controls (3.58 vs. 2.48 respectively; p interaction = 0.04). A total of 6202 visits occurred during the study period. Average patient experience scores did not differ between the experimental and control groups (4.73 vs. 4.75 respectively; p interaction = 0.90). Compared with the control providers, providers with scribes completed more visits per hour (2.29 vs. 1.91; p interaction < 0.001) and generated more wRVUs per hour (3.42 vs. 3.27; p interaction < 0.001).
CONCLUSIONS


In this test of a modified practice model, scribes supported greater patient throughput and improved provider perceptions of documentation burden with no decrement in high patient satisfaction.",2020,Average patient experience scores did not differ between the experimental and control groups (4.73 vs. 4.75 respectively; p interaction = 0.90).,"['Four attending physicians who worked with scribes, 9 control physicians who did not, and their patients in a large, hospital-affiliated academic general internal medicine practice', 'Participating providers worked a total of 664 clinic sessions and returned 547 (82%) surveys']",[],"['Average provider experience scores', 'Average patient experience scores', 'Provider experience and patient experience using 5-point Likert scale surveys from the AMA Steps Forward Team Documentation Module, and visits and wRVUs per hour', 'patient satisfaction, provider satisfaction, and provider productivity']","[{'cui': 'C1320929', 'cui_str': 'Attending physician'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0564385', 'cui_str': 'per hour'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.062576,Average patient experience scores did not differ between the experimental and control groups (4.73 vs. 4.75 respectively; p interaction = 0.90).,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Heckman', 'Affiliation': 'Division of General Internal Medicine and Primary Care, Beth Israel Deaconess Medical Center, East Campus, Shapiro Clinical Center, 330 Brookline Ave, Boston, MA, 02215, USA. jaheckma@bidmc.harvard.edu.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Division of General Internal Medicine and Primary Care, Beth Israel Deaconess Medical Center, East Campus, Shapiro Clinical Center, 330 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Christensen', 'Affiliation': 'Division of General Internal Medicine and Primary Care, Beth Israel Deaconess Medical Center, East Campus, Shapiro Clinical Center, 330 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Reynolds', 'Affiliation': 'Division of General Internal Medicine and Primary Care, Beth Israel Deaconess Medical Center, East Campus, Shapiro Clinical Center, 330 Brookline Ave, Boston, MA, 02215, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05352-5']
396,32492084,Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial.,"Importance


Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.
Objective


To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.
Design, Setting, and Participants


Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled.
Intervention


Convalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity.
Main Outcomes and Measures


Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours.
Results


Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.59 [95% CI, 0.22-1.59]; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.95]; P = .12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P < .001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care.
Conclusion and Relevance


Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference.
Trial Registration


Chinese Clinical Trial Registry: ChiCTR2000029757.",2020,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","['patients with COVID-19', 'patients with coronavirus disease 2019 (COVID-19', '60 [58.3%] male), 101 (98.1%) completed the trial', '103 of a planned 200 patients were enrolled', '103 patients who were randomized (median age, 70 years', 'Patients With Severe and Life-threatening COVID-19', '103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation', '7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020']","['Convalescent Plasma Therapy', 'convalescent plasma therapy', 'Intervention\n\n\nConvalescent plasma in addition to standard treatment (n\u2009=\u200952) vs standard treatment alone (control']","['Clinical improvement', 'time to clinical improvement', '28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR', '28-day mortality', 'adverse events', 'efficacy and adverse effects', 'time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale', 'negative conversion rate of viral PCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1299454', 'cui_str': 'Patient discharged alive'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",103.0,0.448056,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xunliang', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Beijing Hospital, National Respiratory quality control center, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Shangen', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Transfusion, General Hospital of Central Theater Command of PLA, Wuhan, China.'}, {'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Medical Molecular Biology, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & Peking Union, Beijing, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Caiying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Cuihua', 'Initials': 'C', 'LastName': 'Tao', 'Affiliation': 'Department of Blood Transfusion, Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Wuhan Blood Center, Wuhan, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Yongpei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Xiaoxiong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Xiong', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Wuhan Pulmonary Hospital, Wuhan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Man', 'Affiliation': 'Department of Respiratory Medicine, Wuhan Asia General Hospital, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Deng', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Chenyue', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Conghui', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shisheng', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Global Health and Infectious Diseases, Comprehensive AIDS Research Center, and Beijing Advanced Innovation Center for Structural Biology, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanyun', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Pathology, University of Miami, Miami, Florida.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}]",JAMA,['10.1001/jama.2020.10044']
397,32023608,Depressive Symptoms in Stroke Patients: Are There Sex Differences?,"BACKGROUND


We aimed to examine sex differences in symptom characteristics and pharmacological responses in post-stroke depressive (PSD) symptoms.
METHODS


This is a post hoc analysis of EMOTION (ClinicalTrials.gov, NCT01278498), a randomized, placebo-controlled, double-blind trial that examined the efficacy of escitalopram for 3 months on depression in patients with acute stroke. Depressive symptoms were evaluated using the 10-item Montgomery-Åsberg Depression Rating Scale (MADRS). Baseline characteristics, clinical variables, and treatment responses to escitalopram were compared between male and female patients. Treatment responses were defined as changes in MADRS (total score and its components) between baseline and 3 months and were compared between the escitalopram and placebo groups within each sex group. The least square mean was calculated to determine the independent effect of escitalopram, of which interaction was evaluated with patient sex.
RESULTS


Of the 478 patients (intention-to-treat population), 187 (39%) were female. Female patients were significantly older than male patients and demonstrated more severe depressive symptoms at baseline (male vs. female, MADRS score, mean [SD]: 9.7 ± 8.0 vs. 12.2 ± 8.4, p = 0.001), especially in apparent sadness, reported sadness, and reduced appetite items. These differences were significant after adjustment for age and the severity of neurologic deficits. The female escitalopram group showed a significant 3-month improvement in MADRS scores (placebo [n = 86] vs. escitalopram [n = 101], least square mean [95% CI] -2.7 [-4.1 to -1.2] vs. -5.0 [-6.4 to -3.6], p = 0.007), and this efficacy was prominent in apparent sadness, reported sadness, and pessimistic thoughts items. However, there was no significant effect of escitalopram on depressive symptoms in the male group. The treatment responses of escitalopram tended to be more pronounced in the female group, particularly in alleviating a subset of depressive symptoms such as apparent sadness (p for interaction = 0.009).
CONCLUSION


PSD may differ according to sex in its symptom characteristics and treatment responses to escitalopram, and tailored treatment strategies for PSD may therefore be needed.",2020,"Female patients were significantly older than male patients and demonstrated more severe depressive symptoms at baseline (male vs. female, MADRS score, mean [SD]: 9.7 ± 8.0 vs. 12.2 ± 8.4, p = 0.001), especially in apparent sadness, reported sadness, and reduced appetite items.","['Stroke Patients', '478 patients (intention-to-treat population), 187 (39%) were female', 'patients with acute stroke', 'post-stroke depressive (PSD) symptoms', 'male and female patients']","['placebo', 'escitalopram']","['MADRS scores', 'severe depressive symptoms', '10-item Montgomery-Åsberg Depression Rating Scale (MADRS', 'changes in MADRS (total score and its components', 'Depressive Symptoms', 'depressive symptoms', 'Depressive symptoms']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",478.0,0.428279,"Female patients were significantly older than male patients and demonstrated more severe depressive symptoms at baseline (male vs. female, MADRS score, mean [SD]: 9.7 ± 8.0 vs. 12.2 ± 8.4, p = 0.001), especially in apparent sadness, reported sadness, and reduced appetite items.","[{'ForeName': 'Eun-Jae', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jong S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, Republic of Korea, jongskim@amc.seoul.kr.'}, {'ForeName': 'Dae-Il', 'Initials': 'DI', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, Kyung Hee University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Hanyang University, Myongji Hospital, Goyang-si, Republic of Korea.'}, {'ForeName': 'Seong Hwan', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Neurology, Chosun University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Jae-Kwan', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': 'Department of Neurology, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Ji Hoe', 'Initials': 'JH', 'LastName': 'Heo', 'Affiliation': 'Department of Neurology, Yonsei University, Severance Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sung-Il', 'Initials': 'SI', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Keimyung University, Dongsan Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Byung-Chul', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Hallym University, Sacred Heart Hospital, Pyungchon, Republic of Korea.'}, {'ForeName': 'Dong-Eog', 'Initials': 'DE', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Dongguk University, Ilsan hospital, Goyang-si, Republic of Korea.'}, {'ForeName': 'Hahn Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seongheon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Kangwon National University College of Medicine, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Do-Young', 'Initials': 'DY', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Korea University, Ansan Hospital, Ansan-si, Republic of Korea.'}, {'ForeName': 'Jei', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Chungnam University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Woo-Keun', 'Initials': 'WK', 'LastName': 'Seo', 'Affiliation': 'Department of Neurology, Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Yeungnam University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Sang-Won', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Daegu Fatima Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Seong-Ho', 'Initials': 'SH', 'LastName': 'Koh', 'Affiliation': 'Department of Neurology, Hanyang University, Guri Hospital, Guri-si, Republic of Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Hyundai Hospital, Eumseong, Republic of Korea.'}, {'ForeName': 'Smi', 'Initials': 'S', 'LastName': 'Choi-Kwon', 'Affiliation': 'College of Nursing, The Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506116']
398,32014842,"Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial.","BACKGROUND


Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon.
OBJECTIVE


The Physical Activity Toward Health (PATHway) system was developed to provide a comprehensive, remotely monitored, home-based CR program for CVD patients. The PATHway-I study aimed to investigate its feasibility and clinical efficacy during phase III CR.
METHODS


Participants were randomized on a 1:1 basis to the PATHway (PW) intervention group or usual care (UC) control group in a single-blind, multicenter, randomized controlled pilot trial. Outcomes were assessed at completion of phase II CR and 6-month follow-up. The primary outcome was physical activity (PA; Actigraph GT9X link). Secondary outcomes included measures of physical fitness, modifiable cardiovascular risk factors, endothelial function, intima-media thickness of the common carotid artery, and quality of life. System usability and patients' experiences were evaluated only in PW. A mixed-model analysis of variance with Bonferroni adjustment was used to analyze between-group effects over time. Missing values were handled by means of an intention-to-treat analysis. Statistical significance was set at a 2-sided alpha level of .05. Data are reported as mean (SD).
RESULTS


A convenience sample of 120 CVD patients (mean 61.4 years, SD 13.5 years; 22 women) was included. The PATHway system was deployed in the homes of 60 participants. System use decreased over time and system usability was average with a score of 65.7 (SD 19.7; range 5-100). Moderate-to-vigorous intensity PA increased in PW (PW: 127 [SD 58] min to 141 [SD 69] min, UC: 146 [SD 66] min to 143 [SD 71] min; P interaction =.04; effect size of 0.42), while diastolic blood pressure (PW: 79 [SD 11] mmHg to 79 [SD 10] mmHg, UC: 78 [SD 9] mmHg to 83 [SD 10] mmHg; P interaction =.004; effect size of -0.49) and cardiovascular risk score (PW: 15.9% [SD 10.4%] to 15.5% [SD 10.5%], UC: 14.5 [SD 9.7%] to 15.7% [SD 10.9%]; P interaction =.004; effect size of -0.36) remained constant, but deteriorated in UC.
CONCLUSIONS


This pilot study demonstrated the feasibility and acceptability of a technology-enabled, remotely monitored, home-based CR program. Although clinical effectiveness was demonstrated, several challenges were identified that could influence the adoption of PATHway.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02717806; https://clinicaltrials.gov/ct2/show/NCT02717806.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1136/bmjopen-2017-016781.",2020,System use decreased over time and system usability was average with a score of 65.7 (SD 19.7; range 5-100).,"['Participants', 'homes of 60 participants', '120 CVD patients (mean 61.4 years, SD 13.5 years; 22 women) was included', 'CVD patients']","['Cardiac rehabilitation (CR', 'technology-enabled, remotely monitored, home-based CR program', 'PATHway (PW) intervention group or usual care (UC) control group', 'mmHg, UC', 'Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health']","['time and system usability', 'physical fitness, modifiable cardiovascular risk factors, endothelial function, intima-media thickness of the common carotid artery, and quality of life', 'Feasibility, Acceptability, and Clinical Effectiveness', 'Moderate-to-vigorous intensity PA', 'cardiovascular risk score', 'diastolic blood pressure', 'physical activity (PA; Actigraph GT9X link']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0162859', 'cui_str': 'Common carotid artery structure'}, {'cui': 'C0034380'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",120.0,0.15419,System use decreased over time and system usability was average with a score of 65.7 (SD 19.7; range 5-100).,"[{'ForeName': 'Jomme', 'Initials': 'J', 'LastName': 'Claes', 'Affiliation': 'Physiotherapy Department, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Cornelissen', 'Affiliation': 'Department of Rehabilitation Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'McDermott', 'Affiliation': 'Department of Health & Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Moyna', 'Affiliation': 'Department of Health & Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Pattyn', 'Affiliation': 'Department of Rehabilitation Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Cornelis', 'Affiliation': 'Department of Rehabilitation Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gallagher', 'Affiliation': 'Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'McCormack', 'Affiliation': 'Department of Health & Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Newton', 'Affiliation': 'Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Gillain', 'Affiliation': 'Physiotherapy Department, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Budts', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Kaatje', 'Initials': 'K', 'LastName': 'Goetschalckx', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Woods', 'Affiliation': 'Physical Activity for Health, Health Research Institute, Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Moran', 'Affiliation': 'Department of Health & Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Roselien', 'Initials': 'R', 'LastName': 'Buys', 'Affiliation': 'Department of Rehabilitation Sciences, University of Leuven, Leuven, Belgium.'}]",Journal of medical Internet research,['10.2196/14221']
399,32182362,Regional variations in adverse event reporting rates and ACR responses in placebo/standard-of-care arms of rheumatoid arthritis trials.,"OBJECTIVE


Clinical trials are increasingly globalized, and adverse event (AE) rates and treatment responses may differ by geographical region. This study assessed regional differences in AE reporting rates and ACR response rates (ACR20/50) in patients with RA who received placebo/standard-of-care treatment in clinical trials.
METHODS


Patients from the placebo arms of 7 RA trials in the TransCelerate Biopharma Inc database were grouped into 5 geographical regions (Asia, Latin America, Russian Federation and Eastern Europe [RFEE], USA, and Western Europe). Differences in demographics, AE reporting rates and ACR response were evaluated using descriptive statistics and omnibus tests for significance; pairwise comparisons were made between regions, with false discovery rate correction for multiple comparisons.
RESULTS


Among 970 patients included, week 12 AE rates were significantly lower in the RFEE than in Asia, Latin America and the USA (22% vs 51%, 49% and 53%, respectively; P < 0.05 after false discovery rate correction). Similar differences in AE rates across geographical regions were seen at week 52. Among 747 patients with ACR data, the lowest response rates were observed in the USA (ACR20, 22%) and RFEE (ACR50, 3%); the highest response rates were seen in Western Europe (ACR20, 43%) and Latin America (ACR50, 15%). Only the differences in ACR50 response between the RFEE and Latin America remained significant after false discovery rate correction.
CONCLUSION


These placebo/standard-of-care arm data revealed significant regional differences in AE reporting rates and ACR50 response rates. Regional distribution of patients should be considered when conducting RA clinical trials, particularly during recruitment.",2020,"Among 970 patients included, week 12 AE rates were significantly lower in the RFEE than in Asia, Latin America and the USA (22% vs 51%, 49% and 53%, respectively; P < 0.05 after false discovery rate correction).","['747 patients with ACR data', 'patients with RA who received placebo/standard-of-care treatment in clinical trials', 'Patients from the placebo arms of 7 RA trials in the TransCelerate Biopharma Inc database were grouped into 5 geographical regions (Asia, Latin America, Russian Federation and Eastern Europe', '970 patients']",['placebo'],"['ACR50 response', 'lowest response rates', 'highest response rates', 'demographics, AE reporting rates and ACR response', 'ACR response rates (ACR20/50']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0037045', 'cui_str': 'Russian S.F.S.R., Asian'}, {'cui': 'C0015177', 'cui_str': 'Europe, Eastern'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",747.0,0.393666,"Among 970 patients included, week 12 AE rates were significantly lower in the RFEE than in Asia, Latin America and the USA (22% vs 51%, 49% and 53%, respectively; P < 0.05 after false discovery rate correction).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Keebler', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Edmond', 'Initials': 'E', 'LastName': 'Teng', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chia', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Galanter', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Peake', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Tuckwell', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa043']
400,32182190,Benefits of yoga in the treatment of eating disorders: Results of a randomized controlled trial.,"Yoga has begun to be incorporated into the treatment of eating disorders despite limited empirical support for this practice. The purpose of this study was to investigate the efficacy of incorporating Yoga into the treatment of eating disorders. This preliminary randomized controlled trial investigated the benefits of participating in an eight-week Kripalu Yoga program for 53 women with symptoms of bulimia nervosa and binge eating disorder. Compared to waitlist controls, Yoga participants experienced decreases in binge eating frequency, emotional regulation difficulties and self-criticism, and increases in self-compassion. Yoga participants also experienced increases in state mindfulness skills across the eight weeks of the Yoga program. While these results are encouraging and suggest Yoga may have a valuable role to play in the treatment of eating disorders, it is important to stress their tentative nature. Further research, adopting a more rigorous design, is needed to address the limitations of the present study and expand on these findings.",2020,"Compared to waitlist controls, Yoga participants experienced decreases in binge eating frequency, emotional regulation difficulties and self-criticism, and increases in self-compassion.","['eating disorders', '53 women with symptoms of bulimia nervosa and binge eating disorder']",['eight-week Kripalu Yoga program'],"['state mindfulness skills', 'binge eating frequency, emotional regulation difficulties and self-criticism, and increases in self-compassion']","[{'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1510633', 'cui_str': 'Self-Criticism'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",53.0,0.02246,"Compared to waitlist controls, Yoga participants experienced decreases in binge eating frequency, emotional regulation difficulties and self-criticism, and increases in self-compassion.","[{'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Brennan', 'Affiliation': 'Department of Educational Psychology, University of Alberta , Edmonton, Canada.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Whelton', 'Affiliation': 'Department of Educational Psychology, University of Alberta , Edmonton, Canada.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Sharpe', 'Affiliation': 'Department of Psychology, University of Regina , Regina, Canada.'}]",Eating disorders,['10.1080/10640266.2020.1731921']
401,31764363,"The Effects of Perioperative Corticosteroids on Dysphagia Following Surgical Procedures Involving the Anterior Cervical Spine: A Prospective, Randomized, Controlled, Double-Blinded Clinical Trial.","BACKGROUND


Dysphagia is one of the most common complications of surgical procedures in the anterior cervical spine, and can persist up to 2 years postoperatively. Corticosteroids are relatively safe and inexpensive for treating various inflammatory conditions. Perioperative corticosteroid administration for anterior cervical spine procedures may effectively minimize postoperative dysphagia, potentially leading to better outcomes, decreased readmission rates, and improved patient satisfaction. The purpose of this study was to determine the efficacy of perioperative corticosteroids in decreasing the severity and duration of dysphagia following single-level and multilevel anterior cervical spine procedures.
METHODS


Seventy-four patients undergoing elective anterior cervical surgical procedures for degenerative conditions were recruited. Patients with prior cervical procedures; with a diagnosis of fracture, malignancy, or infection; or requiring combined anterior-posterior procedures were excluded. Patients were randomized to perioperative intravenous dexamethasone or saline solution. Doses were administered before incision and at 8 and 16 hours postoperatively. Investigators and patients were blinded to the treatment throughout the study. Dysphagia outcomes were assessed with use of the Bazaz dysphagia scale and the Dysphagia Short Questionnaire (DSQ) at 1 day, 2 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months postoperatively. Statistical analysis was performed comparing means and standard deviations; significance was set at p < 0.05. Clinical outcomes were measured with use of the Quality of Life-12 and Neck Disability Index.
RESULTS


Sixty-four patients were included in the analysis. There were 49 anterior cervical discectomies and fusions, 8 corpectomies, 1 hybrid procedure (corpectomy and adjacent discectomy), and 6 single-level arthroplasties. Patients who received corticosteroids had significantly better dysphagia scores on both the Bazaz scale and DSQ at most time points up to 6 months postoperatively (p < 0.05). On subgroup analysis, patients with multilevel (≥2-level) fusion benefited significantly from corticosteroids on both scales, whereas those with single-level procedures did not. There were no short-term wound complications or infections, and length of stay and fusion rates were comparable.
CONCLUSIONS


Perioperative administration of corticosteroids can reduce dysphagia symptoms following multilevel anterior cervical procedures. Benefit was noted immediately and up to 6 months postoperatively. There was no significant effect on short-term wound-healing, infection rates, length of stay, or fusion rates.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"There was no significant effect on short-term wound-healing, infection rates, length of stay, or fusion rates.
","['Dysphagia Following Surgical Procedures Involving the Anterior Cervical Spine', 'Seventy-four patients undergoing elective anterior cervical surgical procedures for degenerative conditions were recruited', 'multilevel anterior cervical procedures', 'Patients with prior cervical procedures; with a diagnosis of fracture, malignancy, or infection; or requiring combined anterior-posterior procedures were excluded', 'Sixty-four patients were included in the analysis']","['Perioperative Corticosteroids', 'corticosteroids', 'Corticosteroids', 'perioperative intravenous dexamethasone or saline solution', 'perioperative corticosteroids']","['Quality of Life-12 and Neck Disability Index', 'dysphagia scores', 'dysphagia symptoms', 'Dysphagia outcomes', 'Bazaz dysphagia scale and the Dysphagia Short Questionnaire (DSQ', 'Bazaz scale and DSQ', 'short-term wound-healing, infection rates, length of stay, or fusion rates', 'short-term wound complications or infections, and length of stay and fusion rates', 'readmission rates']","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0034380'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",49.0,0.0837887,"There was no significant effect on short-term wound-healing, infection rates, length of stay, or fusion rates.
","[{'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Daffner', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'France', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}, {'ForeName': 'Sanford E', 'Initials': 'SE', 'LastName': 'Emery', 'Affiliation': 'Department of Orthopaedic Surgery, West Virginia University, Morgantown, West Virginia.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00198']
402,32178856,Effectiveness of implementing link nurses and audits and feedback to improve nurses' compliance with standard precautions: A cluster randomized controlled trial.,"BACKGROUND


To prevent health care-associated infections, health organizations recommend that health care workers stringently observe standard precautions (SPs). Nevertheless, compliance with SPs is still suboptimal, emphasizing the need for improvement interventions.
METHODS


A cluster randomized controlled trial with a pretest-post-test design was conducted with 121 clinical nurses who worked in different wards of a university hospital. The intervention group (n = 61) had 3 infection control link nurses nominated and attended systematic audits and feedback. The control group (n = 60) received only the standard multimodal approach used in the hospital. Pre- and post-test assessment of SPs compliance was performed via the World Health Organization observational hand hygiene form and Compliance with Standard Precaution Scale Italian version.
RESULTS


At the post-test, nurses in the intervention group reported significantly increased compliance with hand hygiene, whereas no significant improvement was found in the control group. Nurses in both groups reported significantly increased Compliance with Standard Precaution Scale Italian version scores; however, a higher increase and practical significance was observed in the intervention group. Participants who improved their scores were also compared between groups, showing a significantly greater increase of individual scores in intervention group compared to the control group.
CONCLUSIONS


The findings of this study provide significant practical implications for hospitals seeking to improve compliance with SPs among nurses, showing the effectiveness of using infection control link nurses combined with systematic audits and feedback.",2020,"At the post-test, nurses in the intervention group reported significantly increased compliance with hand hygiene, whereas no significant improvement was found in the control group.",['121 clinical nurses who worked in different wards of a university hospital'],"['3 infection control link nurses nominated and attended systematic audits and feedback', 'standard precautions', 'implementing link nurses and audits and feedback']","['Compliance with Standard Precaution Scale Italian version scores', 'compliance with hand hygiene', 'individual scores']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0085557', 'cui_str': 'Infection Control'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1443867', 'cui_str': 'Standard precautions'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C1443867', 'cui_str': 'Standard precautions'}, {'cui': 'C0222045'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",,0.0429569,"At the post-test, nurses in the intervention group reported significantly increased compliance with hand hygiene, whereas no significant improvement was found in the control group.","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Donati', 'Affiliation': 'Department of Biomedicine and Prevention, Tor Vergata University of Rome, Rome, Italy. Electronic address: d.donati@unicampus.it.'}, {'ForeName': 'Ginevra Azzurra', 'Initials': 'GA', 'LastName': 'Miccoli', 'Affiliation': 'Infection Prevention and Control Team, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cianfrocca', 'Affiliation': 'Department of Biomedicine and Prevention, Tor Vergata University of Rome, Rome, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Di Stasio', 'Affiliation': 'Institute of Biochemistry and Clinical Biochemistry, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'De Marinis', 'Affiliation': 'Research Unit Nursing Science, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tartaglini', 'Affiliation': 'Research Unit Nursing Science, Campus Bio-Medico University of Rome, Rome, Italy.'}]",American journal of infection control,['10.1016/j.ajic.2020.01.017']
403,32178858,Psychomotor Recovery Following Remimazolam-induced Sedation and the Effectiveness of Flumazenil as an Antidote.,"PURPOSE


Remimazolam tosylate (HR-7056) is a novel ester-type benzodiazepine with ultrafast onset of effect. The compound is being developed for sedation induction and maintenance during anesthesia. It was approved for procedural anesthesia in December 2019 by the National Medical Products Administration of China. Previous studies have reported on remimazolam's effects on consciousness and cognition. Although the time to full psychomotor recovery after remimazolam-mediated sedation is critical for decisions regarding hospital discharge, relevant clinical evidence is still lacking. This study investigated the residual psychomotor effects of remimazolam and their recovery from sedating treatment in 2 simulated clinical settings: (1) single-dose administration for sedation initiation; and (2) constant rate infusion for sedation maintenance.
METHODS


A single-ascending-dose, parallel-group, midazolam-controlled study and a 2-way crossover study evaluating the reversal effect of flumazenil versus placebo after a 2-h constant rate infusion were conducted with HR-7056 in 87 Chinese healthy volunteers; the studies used a double-blind, randomized trial design. A battery of psychomotor tests was administered before dosing and several times postdose over 4-6 h. Pharmacokinetic, sedation, and safety assessments were performed throughout the studies.
FINDINGS


After bolus infusion, the Bispectral Index score decreased in a concentration-dependent manner with HR-7056, accompanied by a sharp drop of Modified Observer's Assessment of Alertness/Sedation score. The recovery of consciousness was much faster with HR-7056 than with midazolam. During the constant rate infusion, the Bispectral Index score was maintained between 40 and 60 with an average plasma remimazolam concentration of ~1000 ng/mL. Subjects' performance in saccadic and smooth pursuit eye movement, body sway, test of choice reaction time, and word recall was significantly impaired after single-dose midazolam and after constant rate infusion of remimazolam. The end-of-infusion injection of flumazenil shortened the median time to full alertness to 3.5 min and effectively reversed psychomotor and cardiovascular dysfunction.
IMPLICATIONS


The study results showed quicker psychomotor recovery from sedation in the remimazolam-treated group. The moderate and short-lasting residual effect of remimazolam after 2-h conscious sedation proposes a need for psychomotor assessment(s) before hospital discharge. ClinicalTrials.gov identifiers: NCT01970072 and NCT03444480.",2020,"ng/mL. Subjects' performance in saccadic and smooth pursuit eye movement, body sway, test of choice reaction time, and word recall was significantly impaired after single-dose midazolam and after constant rate infusion of remimazolam.","['December 2019 by the National Medical Products Administration of China', '87 Chinese healthy volunteers']","['HR-7056', 'midazolam', 'flumazenil versus placebo', 'Flumazenil', 'remimazolam', 'Remimazolam-Induced Sedation', 'flumazenil']","['saccadic and smooth pursuit eye movement, body sway, test of choice reaction time, and word recall', 'Bispectral Index score', ""Modified Observer's Assessment of Alertness/Sedation score"", 'median time to full alertness', 'Psychomotor Recovery', 'recovery of consciousness']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0016293', 'cui_str': 'Flumazenil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C0034158', 'cui_str': 'Pursuit, Smooth'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]",87.0,0.179989,"ng/mL. Subjects' performance in saccadic and smooth pursuit eye movement, body sway, test of choice reaction time, and word recall was significantly impaired after single-dose midazolam and after constant rate infusion of remimazolam.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China; Clinical Trial Center, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. Electronic address: connie_6096@126.com.'}, {'ForeName': 'Nuoer', 'Initials': 'N', 'LastName': 'Sang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Kaicheng', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China. Electronic address: connie_6096@126.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.02.006']
404,32163097,Comparison of Carboplatin Plus Pemetrexed Followed by Maintenance Pemetrexed With Docetaxel Monotherapy in Elderly Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer: A Phase 3 Randomized Clinical Trial.,"Importance


Few clinical trials have been specifically designed for elderly patients with advanced non-small cell lung cancer (NSCLC), and the anticipated increase in the number of such patients has prompted a search for new treatment options that provide a greater palliative benefit.
Objective


To determine whether treatment with carboplatin plus pemetrexed followed by pemetrexed maintenance is noninferior compared with docetaxel monotherapy with regard to overall survival (OS) for elderly patients with advanced nonsquamous NSCLC.
Design, Setting, and Participants


This open-label, multicenter, noninferiority phase 3 randomized clinical trial was conducted at 79 institutions in Japan. Cytotoxic chemotherapy-naive patients with advanced nonsquamous NSCLC, an Eastern Cooperative Oncology Group performance status of 0 or 1, and age of 75 years or older were enrolled between August 2013 and February 2017. Data were analyzed from November 2018 to February 2019.
Interventions


Patients were randomized to receive either docetaxel monotherapy (60 mg/m2) every 3 weeks or 4 cycles of carboplatin (area under the curve of 5) plus pemetrexed (500 mg/m2) administered every 3 weeks followed by maintenance therapy with the same dose of pemetrexed for 3 weeks.
Main Outcomes and Measures


The primary end point was OS analyzed on an intention-to-treat basis with a noninferiority margin of 1.154 for the upper limit of the 95% CI of the hazard ratio (HR) estimated with a stratified Cox regression model.
Results


Of the 433 enrolled patients, 250 (57.7%) were male, and the median (range) age was 78 (75-88) years. The median OS was 15.5 months (95% CI, 13.6-18.4) in the docetaxel group (n = 217) and 18.7 months (95% CI, 16.0-21.9) in the carboplatin-pemetrexed group (n = 216), with a stratified HR for OS of 0.850 (95% CI, 0.684-1.056; P for noninferiority = .003). Progression-free survival was also longer in the carboplatin-pemetrexed group (unstratified HR, 0.739; 95% CI, 0.609-0.896). Compared with those in the docetaxel group, those in the carboplatin-pemetrexed had lower rates of leukopenia (60 of 214 [28.0%] vs 147 of 214 [68.7%]) and neutropenia (99 of 214 [46.3%] vs 184 of 214 [86.0%]) of grade 3 or 4 and of febrile neutropenia (9 of 214 [4.2%] vs 38 of 214 [17.8%]) and higher rates of thrombocytopenia (55 of 214 [25.7%] vs 3 of 214 [1.4%]) and anemia (63 of 214 [29.4%] vs 4 of 214 [1.9%]) of grade 3 or 4. Dose reductions were less frequent with carboplatin-pemetrexed.
Conclusion and Relevance


Carboplatin-pemetrexed treatment followed by pemetrexed maintenance is a valid option for first-line treatment of elderly patients with advanced nonsquamous NSCLC.
Trial Registration


University Hospital Medical Information Network Clinical Trials Registry Identifier: UMIN000011460.",2020,"Progression-free survival was also longer in the carboplatin-pemetrexed group (unstratified HR, 0.739; 95% CI, 0.609-0.896).","['Elderly Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer', 'naive patients with advanced nonsquamous NSCLC, an Eastern Cooperative Oncology Group performance status of 0 or 1, and age of 75 years or older were enrolled between August 2013 and February 2017', '433 enrolled patients, 250 (57.7%) were male, and the median (range) age was 78 (75-88) years', 'Data were analyzed from November 2018 to February 2019', '79 institutions in Japan', 'elderly patients with advanced non-small cell lung cancer (NSCLC', 'elderly patients with advanced nonsquamous NSCLC']","['carboplatin-pemetrexed', 'docetaxel monotherapy', 'Carboplatin Plus Pemetrexed', 'carboplatin (area under the curve of 5) plus pemetrexed', 'Docetaxel Monotherapy', 'docetaxel', 'carboplatin plus pemetrexed', 'Pemetrexed', 'Cytotoxic chemotherapy']","['rates of thrombocytopenia', 'median OS', 'rates of leukopenia', 'overall survival (OS', 'febrile neutropenia', 'neutropenia', 'Progression-free survival', 'anemia']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",433.0,0.153118,"Progression-free survival was also longer in the carboplatin-pemetrexed group (unstratified HR, 0.739; 95% CI, 0.609-0.896).","[{'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nokihara', 'Affiliation': 'Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Nomura', 'Affiliation': 'Japan Clinical Oncology Group (JCOG) Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Niho', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan.'}, {'ForeName': 'Hidehito', 'Initials': 'H', 'LastName': 'Horinouchi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Azuma', 'Affiliation': 'Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Yoneshima', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Haruyasu', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Hosomi', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Atagi', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kinki-chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Ozaki', 'Affiliation': 'Division of Medical Oncology, Kishiwada City Hospital, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Horiike', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Kanagawa, Japan.""}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}]",JAMA oncology,['10.1001/jamaoncol.2019.6828']
405,30842540,Ultrafine particles and ozone perturb norepinephrine clearance rather than centrally generated sympathetic activity in humans.,"Cardiovascular risk rapidly increased following exposure to air pollution. Changes in human autonomic regulation have been implicated based on epidemiological associations between exposure estimates and indirect autonomic nervous system measurements. We conducted a mechanistic study to test the hypothesis that, in healthy older individuals, well-defined experimental exposure to ultrafine carbon particles (UFP) increases sympathetic nervous system activity and more so with added ozone (O 3 ). Eighteen participants (age >50 years, 6 women) were exposed to filtered air (Air), UFP, and UFP + O 3  combination for 3 hours during intermittent bicycle ergometer training in a randomized, crossover, double-blind fashion. Two hours following exposure, respiration, electrocardiogram, blood pressure, and muscle sympathetic nerve activity (MSNA) were recorded at supine rest, during deep breathing, and during a Valsalva manoeuvre. Catechols and inflammatory marker levels were measured in venous blood samples. Induced sputum was obtained 3.5 h after exposure. Combined exposure to UFP + O 3  but not UFP alone, caused a significant increase in sputum neutrophils and circulating leucocytes. Norepinephrine was modestly increased while the ratio between plasma dihydroxyphenylglycol (DHPG) and norepinephrine levels, a marker for norepinephrine clearance, was reduced with UFP + O 3 . Resting MSNA was not different (47 ± 12 with Air, 47 ± 14 with UFP, and 45 ± 14 bursts/min with UFP + O 3 ). Indices of parasympathetic heart rate control were unaffected by experimental air pollution. Our study suggests that combined exposure to modest UFP and O 3  levels increases peripheral norepinephrine availability through decreased clearance rather than changes in central autonomic activity. Pulmonary inflammatory response may have perturbed pulmonary endothelial norepinephrine clearance.",2019,"Combined exposure to UFP + O 3  but not UFP alone, caused a significant increase in sputum neutrophils and circulating leucocytes.","['healthy older individuals', 'humans', 'Eighteen participants (age >50 years, 6 women']","['filtered air (Air), UFP, and UFP\u2009+\u2009O 3  combination for 3\u2009hours during intermittent bicycle ergometer training', 'Norepinephrine', 'ultrafine carbon particles (UFP']","['Induced sputum', 'respiration, electrocardiogram, blood pressure, and muscle sympathetic nerve activity (MSNA', 'plasma dihydroxyphenylglycol (DHPG) and norepinephrine levels, a marker for norepinephrine clearance', 'sputum neutrophils and circulating leucocytes', 'Catechols and inflammatory marker levels', 'Cardiovascular risk']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0077801', 'cui_str': 'Ultrafine'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}]","[{'cui': 'C3179346', 'cui_str': 'Sputum, Induced'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0007413', 'cui_str': 'o-Dihydroxybenzenes'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.026781,"Combined exposure to UFP + O 3  but not UFP alone, caused a significant increase in sputum neutrophils and circulating leucocytes.","[{'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Heusser', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Tank', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Holz', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 30625, Hannover, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'May', 'Affiliation': 'MHH CRC Core Facility & Centre for Pharmacology and Toxicology, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brinkmann', 'Affiliation': 'Institute for Clinical Pharmacology, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Engeli', 'Affiliation': 'Institute for Clinical Pharmacology, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Diedrich', 'Affiliation': 'Department of Medicine, Division of Clinical Pharmacology, Autonomic Dysfunction Center, Vanderbilt University School of Medicine, Nashville, TN, 37232, USA.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Framke', 'Affiliation': 'Institute of Biostatistics, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institute of Biostatistics, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Großhennig', 'Affiliation': 'Institute of Biostatistics, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Jan Danser', 'Affiliation': 'Division of Vascular Medicine and Pharmacology, Department of Internal Medicine, Erasmus Medical Center, 3015 GE, Rotterdam, The Netherlands.'}, {'ForeName': 'Fred C G J', 'Initials': 'FCGJ', 'LastName': 'Sweep', 'Affiliation': 'Department of Laboratory Medicine, Radboud University Medical Centre, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schindler', 'Affiliation': 'MHH CRC Core Facility & Centre for Pharmacology and Toxicology, Hannover Medical School, 30625, Hannover, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schwarz', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 30625, Hannover, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Krug', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 30625, Hannover, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany. jens.jordan@dlr.de.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Hohlfeld', 'Affiliation': 'Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), 30625, Hannover, Germany.'}]",Scientific reports,['10.1038/s41598-019-40343-w']
406,30846834,Acute effects of active breaks during prolonged sitting on subcutaneous adipose tissue gene expression: an ancillary analysis of a randomised controlled trial.,"Active breaks in prolonged sitting has beneficial impacts on cardiometabolic risk biomarkers. The molecular mechanisms include regulation of skeletal muscle gene and protein expression controlling metabolic, inflammatory and cell development pathways. An active communication network exists between adipose and muscle tissue, but the effect of active breaks in prolonged sitting on adipose tissue have not been investigated. This study characterized the acute transcriptional events induced in adipose tissue by regular active breaks during prolonged sitting. We studied 8 overweight/obese adults participating in an acute randomized three-intervention crossover trial. Interventions were performed in the postprandial state and included: (i) prolonged uninterrupted sitting; or prolonged sitting interrupted with 2-minute bouts of (ii) light- or (iii) moderate-intensity treadmill walking every 20 minutes. Subcutaneous adipose tissue biopsies were obtained after each condition. Microarrays identified 36 differentially expressed genes between the three conditions (fold change ≥0.5 in either direction; p < 0.05). Pathway analysis indicated that breaking up of prolonged sitting led to differential regulation of adipose tissue metabolic networks and inflammatory pathways, increased insulin signaling, modulation of adipocyte cell cycle, and facilitated cross-talk between adipose tissue and other organs. This study provides preliminary insight into the adipose tissue regulatory systems that may contribute to the physiological effects of interrupting prolonged sitting.",2019,Microarrays identified 36 differentially expressed genes between the three conditions (fold change ≥0.5 in either direction; p < 0.05).,['8 overweight/obese adults participating in an acute randomized three-intervention crossover trial'],"['active breaks', 'i) prolonged uninterrupted sitting; or prolonged sitting interrupted with 2-minute bouts of (ii) light- or (iii) moderate-intensity treadmill walking every 20\u2009minutes']","['Subcutaneous adipose tissue biopsies', 'subcutaneous adipose tissue gene expression', 'cardiometabolic risk biomarkers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0585317', 'cui_str': 'Every twenty minutes (qualifier value)'}]","[{'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",8.0,0.0788603,Microarrays identified 36 differentially expressed genes between the three conditions (fold change ≥0.5 in either direction; p < 0.05).,"[{'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Grace', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Melissa F', 'Initials': 'MF', 'LastName': 'Formosa', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Kiymet', 'Initials': 'K', 'LastName': 'Bozaoglu', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Bergouignan', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes and Anschutz Health and Wellness Center, University of Colorado, School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Brozynska', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Carey', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Camilla Bertuzzo', 'Initials': 'CB', 'LastName': 'Veiga', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Parneet', 'Initials': 'P', 'LastName': 'Sethi', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Dillon', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bertovic', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Inouye', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Owen', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Bronwyn A', 'Initials': 'BA', 'LastName': 'Kingwell', 'Affiliation': 'Baker Heart & Diabetes Institute, Melbourne, Australia. Bronwyn.kingwell@baker.edu.au.'}]",Scientific reports,['10.1038/s41598-019-40490-0']
407,32118792,Extreme intrusive force affects the expression of c-Fos and matrix metallopeptidase 9 in human dental pulp tissues.,"This study aimed to investigate the expression of c-Fos and matrix metallopeptidase 9 (MMP-9) in dental pulp of patients receiving orthodontic treatment via wire appliance.Fifteen patients (30 teeth in total) were randomly assigned to five groups: t = 0, t = 1, t = 4, t = 8 and t = 12 (n = 6). The first maxillary premolars of patients in the t = 0 group were extracted without any orthodontic treatment. An intrusive force of 300 g was applied on first maxillary premolars in the other four groups via wire appliances. This force was maintained for 1 week for t = 1 group, 4 weeks for t = 4 group, 8 weeks for t = 8 group, or 12 weeks for t = 12 group, before the teeth were extracted.The expression of c-Fos and MMP-9 in the pulps of each group was analyzed by immunohistochemical staining and real-time PCR. The relationship in the protein expression between c-Fos and MMP-9 in the dental pulp was analyzed by Pearson correlation analysis.Intrusive force of 300 g increased the expression of both c-Fos and MMP-9 in the dental pulp. The protein expression of MMP-9 in the dental pulp was significantly correlated with the expression of c-Fos (P < .001).Extreme intrusive force upregulates c-Fos and MMP-9 expression in the dental pulp. Moreover, protein expression of c-Fos and MMP-9 is significantly correlated under intrusive force.",2020,The expression of c-Fos and MMP-9 in the pulps of each group was analyzed by immunohistochemical staining and real-time PCR.,"['Intrusive force of 300', 'Fifteen patients (30 teeth in total', 'dental pulp of patients receiving orthodontic treatment via wire appliance']",[],"['expression of both c-Fos and MMP-9', 'protein expression of c-Fos and MMP-9', 'expression of c-Fos and MMP-9', 'protein expression of MMP-9']","[{'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011399', 'cui_str': 'Dental Pulp'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005978', 'cui_str': 'Bone Wires'}, {'cui': 'C0243112'}]",[],"[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.0158383,The expression of c-Fos and MMP-9 in the pulps of each group was analyzed by immunohistochemical staining and real-time PCR.,"[{'ForeName': 'Guanghong', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': 'Department of Oral Geriatrics, Hospital of Stomatology, Jilin University, Jilin Provincial Key Laboratory of Tooth Development and Bone Remodeling.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Oral and Maxillofacial Surgery.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthodontics, Hospital of Stomatology, Jilin University.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Orthodontics, Hospital of Stomatology, Jilin University.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Department of Orthodontics, Hospital of Stomatology, Jilin University.'}]",Medicine,['10.1097/MD.0000000000019394']
408,32150072,"Respiratory muscle training in stroke patients with respiratory muscle weakness, dysphagia, and dysarthria - a prospective randomized trial.","OBJECTIVE


To examine the efficacy of combined inspiratory and expiratory respiratory muscle training (RMT) with respect to the swallowing function, pulmonary function, functional performance, and dysarthria in patients with stroke.
DESIGN


Prospective, randomized controlled trial.
SETTING


Tertiary hospital.
PARTICIPANTS


The trial included 21 subjects (12 men, 9 women) aged 35 to 80 years presenting with 6 months history of unilateral stroke, respiratory muscle weakness (≥70% predicted maximal inspiratory pressure (MIP) and/or ≤70% maximal expiratory pressure (MEP)), dysphagia, or dysarthria. These subjects were randomly assigned to the control (n = 10, rehabilitation) and experimental (n = 11, rehabilitation with RMT) groups.
INTERVENTION


Inspiratory RMT starting from 30% to 60% of MIP and expiratory RMT starting from 15% to 75% of MEP for 5 days/week for 6 weeks.
MAIN OUTCOME MEASURES


MIP, MEP, pulmonary function, peak cough flow, perception of dyspnea, Fatigue Assessment Scale, Modified Rankin Scale, Brunnstrom stage, Barthel index, Functional Oral Intake Scale (FOIS), and parameters of voice analysis.
RESULTS


Significant differences were observed between both groups in terms of MIP, forced vital capacity (FVC), and forced expiratory volume per second (FEV1) of the percentage predicted. Significant difference was found with respect to the change in fatigue, shimmer percent, amplitude perturbation quotient, and voice turbulence index (VTI) according to the acoustic analysis in the RMT group. The FEV1/FVC ratio was negatively correlated with jitter percent, relative average perturbation, pitch perturbation quotient, and VTI; the maximum mid-expiratory flow (MMEF) and MMEF% were also negatively correlated with VTI. Significant differences among participants of the same group were observed while comparing the Brunnstrom stage before and after training of the affected limbs and the Barthel scale and FOIS scores in both the groups.
CONCLUSIONS


Altogether, 6-week combined inspiratory and expiratory RMT is feasible as adjuvant therapy for stroke patients to improve fatigue level, respiratory muscle strength, lung volume, respiratory flow, and dysarthria.Clinical trial registration number (Clinical Trial Identifier): NCT03491111.",2020,"Significant difference was found with respect to the change in fatigue, shimmer percent, amplitude perturbation quotient, and voice turbulence index (VTI) according to the acoustic analysis in the RMT group.","['21 subjects (12 men, 9 women) aged 35 to 80 years presenting with 6 months history of unilateral stroke, respiratory muscle weakness (≥70% predicted maximal inspiratory pressure (MIP', 'Tertiary hospital', 'patients with stroke', 'stroke patients', 'stroke patients with respiratory muscle weakness, dysphagia, and dysarthria ']","['combined inspiratory and expiratory RMT', 'combined inspiratory and expiratory respiratory muscle training (RMT', 'Inspiratory RMT', 'Respiratory muscle training']","['swallowing function, pulmonary function, functional performance, and dysarthria', 'Barthel scale and FOIS scores', 'fatigue level, respiratory muscle strength, lung volume, respiratory flow, and dysarthria', 'maximal expiratory pressure (MEP)), dysphagia, or dysarthria', 'MIP, MEP, pulmonary function, peak cough flow, perception of dyspnea, Fatigue Assessment Scale, Modified Rankin Scale, Brunnstrom stage, Barthel index, Functional Oral Intake Scale (FOIS), and parameters of voice analysis', 'FEV1/FVC ratio', 'relative average perturbation, pitch perturbation quotient, and VTI; the maximum mid-expiratory flow (MMEF) and MMEF', 'MIP, forced vital capacity (FVC), and forced expiratory volume per second (FEV1', 'change in fatigue, shimmer percent, amplitude perturbation quotient, and voice turbulence index (VTI']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1836141', 'cui_str': 'Respiratory muscle weakness'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0013362', 'cui_str': 'Dysarthosis'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}]","[{'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C3853978'}, {'cui': 'C0013362', 'cui_str': 'Dysarthosis'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C4082175', 'cui_str': 'Maximal Expiratory Pressure'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0222045'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0234791', 'cui_str': 'Abnormal pitch (finding)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0231985', 'cui_str': 'Mean maximum expiratory flow, function (observable entity)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0565930', 'cui_str': '/s'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",21.0,0.0589224,"Significant difference was found with respect to the change in fatigue, shimmer percent, amplitude perturbation quotient, and voice turbulence index (VTI) according to the acoustic analysis in the RMT group.","[{'ForeName': 'Mei-Yun', 'Initials': 'MY', 'LastName': 'Liaw', 'Affiliation': 'Department of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Chia-Hao', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Chau-Peng', 'Initials': 'CP', 'LastName': 'Leong', 'Affiliation': 'Department of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Ching-Yi', 'Initials': 'CY', 'LastName': 'Liao', 'Affiliation': 'Department of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Lin-Yi', 'Initials': 'LY', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Cheng-Hsien', 'Initials': 'CH', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Meng-Chih', 'Initials': 'MC', 'LastName': 'Lin', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Department of Respiratory Therapy, Chang Gung Memorial Hospital Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}]",Medicine,['10.1097/MD.0000000000019337']
409,32150085,A randomized controlled trial for prevention of acute exacerbation of stable chronic obstructive pulmonary disease with acupoint application of traditional Chinese medicine: Study protocol clinical trial (SPIRIT Compliant).,"INTRODUCTION


Chronic obstructive pulmonary disease (COPD) is a major public health problem that severely affects the quality of life of patients and may even endanger their lives. Although modern medicine has achieved significant results in relieving the clinical manifestations of COPD, it is difficult to prevent its progression and acute exacerbation entirely. As one of the classic aspects of acupuncture and moxibustion therapy, acupoint application of traditional Chinese medicine (TCM) can improve the clinical efficacy of western medicine in treating COPD. To date, however,there is no high-quality clinical trial to assess the effectiveness of TCM acupoint application directly in preventing acute exacerbation of stable COPD.
METHODS


The study is a randomized, double-blind, placebo-controlled trial, in which 200 stable COPD patients will be randomly and equally divided into the experimental group or control group. Both groups will undergo standard Western medicine treatment; however, the patients in the experimental group will be also treated with TCM acupoint application, while the control group will be given placebo acupoint application. The duration of the treatment will be 1 month and a follow-up for 11 months. The primary outcome will be the number of acute exacerbation episodes of COPD, and the secondary outcomes will include the lung function, St George's Respiratory Questionnaire, COPD Assessment Test, and 6-Minute Walk Test. A safety assessment will also be performed during the trial.
DISCUSSION


The aim of this study is to evaluate the efficacy and safety of TCM acupoint application in preventing acute exacerbation of stable COPD. Our study will provide sound evidence to support the evidence-based medicine of TCM acupoint application as an additional measure in the prevention of acute exacerbation of stable COPD.
TRIAL REGISTRATION


ChiCTR1900026564, Registered 14 October, 2019.",2020,The aim of this study is to evaluate the efficacy and safety of TCM acupoint application in preventing acute exacerbation of stable COPD.,"['200 stable COPD patients', 'stable chronic obstructive pulmonary disease with', 'Chronic obstructive pulmonary disease (COPD']","['acupuncture and moxibustion therapy, acupoint application of traditional Chinese medicine (TCM', 'TCM acupoint application', 'placebo', 'placebo acupoint application', 'acupoint application of traditional Chinese medicine']","[""number of acute exacerbation episodes of COPD, and the secondary outcomes will include the lung function, St George's Respiratory Questionnaire, COPD Assessment Test, and 6-Minute Walk Test""]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxabustion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}]",200.0,0.15242,The aim of this study is to evaluate the efficacy and safety of TCM acupoint application in preventing acute exacerbation of stable COPD.,"[{'ForeName': 'Chuantao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Hongjing', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Wenfan', 'Initials': 'W', 'LastName': 'Gan', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Kunlan', 'Initials': 'K', 'LastName': 'Long', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, PR China.'}, {'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Qingsong', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Peiyang', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Critical Care Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, PR China.'}]",Medicine,['10.1097/MD.0000000000019396']
410,32150108,Effects of high-intensity interval and moderate-intensity continuous aerobic exercise on diabetic obese patients with nonalcoholic fatty liver disease: A comparative randomized controlled trial.,"BACKGROUND


Some studies assessed the effect of aerobic exercise on diabetic obese patients with hepatic disease, while very limited studies compared high-intensity interval (HII) versus moderate-intensity continuous (MIC) on diabetic obese patients with non-alcoholic fatty liver disease (NAFLD).
OBJECTIVES


This study was designed to assess the effects of HII versus MIC on intrahepatic triglycerides (IHTG) and visceral lipids in diabetic obese patients with NAFLD.
DESIGN


Randomized controlled trial.
METHODS


Forty-seven diabetic obese individuals with NAFLD were enrolled in this study. The individuals were randomly divided into 16 in HII group, 15 in MIC group, and 16 in the controls. HII group received HII exercise, MIC group received 8-week MIC exercise while the control group did not receive any exercise intervention. IHTG and visceral lipids were assessed pre- and post-intervention.
RESULTS


Baseline and clinical characteristics showed nonsignificant difference among the 3 groups (P > .05). Both HII and MIC groups showed a significant reduction in hepatic fat and visceral lipids (P < .05), while the controls showed nonsignificant difference (P > .05) after completing the study intervention. Postintervention analysis showed nonsignificant changes between the HII and MIC groups (P > .05).
CONCLUSIONS


Exercise training wither HII or MIC aerobic exercise reduces IHGT and visceral lipids in diabetic obese patients with NAFLD. No differences were observed between the effects of both exercise programs on diabetic obese patients with NAFLD.",2020,"Both HII and MIC groups showed a significant reduction in hepatic fat and visceral lipids (P < .05), while the controls showed nonsignificant difference (P > .05) after completing the study intervention.","['diabetic obese patients with nonalcoholic fatty liver disease', 'diabetic obese patients with NAFLD', 'Forty-seven diabetic obese individuals with NAFLD', 'diabetic obese patients with hepatic disease', 'diabetic obese patients with non-alcoholic fatty liver disease (NAFLD']","['exercise programs', 'Exercise training wither HII or MIC aerobic exercise', 'aerobic exercise', 'high-intensity interval and moderate-intensity continuous aerobic exercise', 'HII exercise, MIC group received 8-week MIC exercise while the control group did not receive any exercise intervention', 'HII versus MIC']","['hepatic fat and visceral lipids', 'IHGT and visceral lipids', 'intrahepatic triglycerides (IHTG) and visceral lipids', 'IHTG and visceral lipids']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",47.0,0.0811938,"Both HII and MIC groups showed a significant reduction in hepatic fat and visceral lipids (P < .05), while the controls showed nonsignificant difference (P > .05) after completing the study intervention.","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Sayed A', 'Initials': 'SA', 'LastName': 'Tantawy', 'Affiliation': 'Department of Physiotherapy, College of Medical and Health Sciences, Ahlia University, Manama, Kingdom of Bahrain.'}, {'ForeName': 'Dalia M', 'Initials': 'DM', 'LastName': 'Kamel', 'Affiliation': 'Department of Physiotherapy, College of Medical and Health Sciences, Ahlia University, Manama, Kingdom of Bahrain.'}, {'ForeName': 'Bader A', 'Initials': 'BA', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Tamer E', 'Initials': 'TE', 'LastName': 'Elnegamy', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Gaber S', 'Initials': 'GS', 'LastName': 'Soliman', 'Affiliation': 'Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Physical Therapy, Kasr Al-Aini Hospital, Cairo University, Giza, Egypt.'}]",Medicine,['10.1097/MD.0000000000019471']
411,31481560,"The dietary education trial in carbohydrate counting (DIET-CARB Study): study protocol for a randomised, parallel, open-label, intervention study comparing different approaches to dietary self-management in patients with type 1 diabetes.","INTRODUCTION


Clinical guidelines recommend that patients with type 1 diabetes (T1D) learn carbohydrate counting or similar methods to improve glycaemic control. Although systematic educating in carbohydrate counting is still not offered as standard-of-care for all patients on multiple daily injections (MDI) insulin therapy in outpatient diabetes clinics in Denmark. This may be due to the lack of evidence as to which educational methods are the most effective for training patients in carbohydrate counting. The objective of this study is to compare the effect of two different educational programmes in carbohydrate counting with the usual dietary care on glycaemic control in patients with T1D.
METHODS AND ANALYSIS


The study is designed as a randomised controlled trial with a parallel-group design. The total study duration is 12 months with data collection at baseline, 6 and 12 months. We plan to include 231 Danish adult patients with T1D. Participants will be randomised to one of three dietician-led interventions: (1) a programme in basic carbohydrate counting, (2) a programme in advanced carbohydrate counting including an automated bolus calculator or (3) usual dietary care. The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline to end of the intervention period (week 24) between and within each of the three study groups. Other outcome measures include changes in other parameters of plasma glucose variability (eg, time in range), body weight and composition, lipid profile, blood pressure, mathematical literacy skills, carbohydrate estimation accuracy, dietary intake, diet-related quality of life, perceived competencies in dietary management of diabetes and perceptions of an autonomy supportive dietician-led climate, physical activity and urinary biomarkers.
ETHICS AND DISSEMINATION


The protocol has been approved by the Ethics Committee of the Capital Region, Copenhagen, Denmark. Study findings will be disseminated widely through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03623113).",2019,The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline to end of the intervention period (week 24) between and within each of the three study groups.,"['patients with T1D', 'outpatient diabetes clinics in Denmark', '231 Danish adult patients with T1D. Participants', 'patients with type 1 diabetes', 'patients with type 1 diabetes (T1D']","['dietary self-management', 'dietician-led interventions: (1) a programme in basic carbohydrate counting, (2) a programme in advanced carbohydrate counting including an automated bolus calculator or (3) usual dietary care']","['plasma glucose variability (eg, time in range), body weight and composition, lipid profile, blood pressure, mathematical literacy skills, carbohydrate estimation accuracy, dietary intake, diet-related quality of life, perceived competencies in dietary management of diabetes and perceptions of an autonomy supportive dietician-led climate, physical activity and urinary biomarkers', 'glycated haemoglobin A1c or mean amplitude of glycaemic excursions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0034380'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.118753,The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline to end of the intervention period (week 24) between and within each of the three study groups.,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Ewers', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark bettina.ewers@regionh.dk.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Henrik Ullits', 'Initials': 'HU', 'LastName': 'Andersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Jens Meldgaard', 'Initials': 'JM', 'LastName': 'Bruun', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-029859']
412,31481568,'Optimising PharmacoTherapy In the multimorbid elderly in primary CAre' (OPTICA) to improve medication appropriateness: study protocol of a cluster randomised controlled trial.,"INTRODUCTION


Multimorbidity and polypharmacy are major risk factors for potentially inappropriate prescribing (eg, overprescribing and underprescribing), and systematic medication reviews are complex and time consuming. In this trial, the investigators aim to determine if a systematic software-based medication review improves medication appropriateness more than standard care in older, multimorbid patients with polypharmacy.
METHODS AND ANALYSIS


Optimising PharmacoTherapy In the multimorbid elderly in primary CAre is a cluster randomised controlled trial that will include outpatients from the Swiss primary care setting, aged ≥65 years with ≥three chronic medical conditions and concurrent use of ≥five chronic medications. Patients treated by the same general practitioner (GP) constitute a cluster, and clusters are randomised 1:1 to either a standard care sham intervention, in which the GP discusses with the patient if the medication list is complete, or a systematic medication review intervention based on the use of the 'Systematic Tool to Reduce Inappropriate Prescribing'-Assistant (STRIPA). STRIPA is a web-based clinical decision support system that helps customise medication reviews. It is based on the validated 'Screening Tool of Older Person's Prescriptions' (STOPP) and 'Screening Tool to Alert doctors to Right Treatment' (START) criteria to detect potentially inappropriate prescribing. The trial's follow-up period is 12 months. Outcomes will be assessed at baseline, 6 and 12 months. The primary endpoint is medication appropriateness, as measured jointly by the change in the Medication Appropriateness Index (MAI) and Assessment of Underutilisation (AOU). Secondary endpoints include the degree of polypharmacy, overprescribing and underprescribing, the number of falls and fractures, quality of life, the amount of formal and informal care received by patients, survival, patients' quality adjusted life years, patients' medical costs, cost-effectiveness of the intervention, percentage of recommendations accepted by GPs, percentage of recommendation rejected by GPs and patients' willingness to have medications deprescribed.
ETHICS AND DISSEMINATION


The ethics committee of the canton of Bern in Switzerland approved the trial protocol. The results of this trial will be published in a peer-reviewed journal.
MAIN FUNDING


Swiss National Science Foundation, National Research Programme (NRP 74) 'Smarter Healthcare'.
TRIAL REGISTRATION NUMBERS


Clinicaltrials.gov (NCT03724539), KOFAM (Swiss national portal) (SNCTP000003060), Universal Trial Number (U1111-1226-8013).",2019,"Secondary endpoints include the degree of polypharmacy, overprescribing and underprescribing, the number of falls and fractures, quality of life, the amount of formal and informal care received by patients, survival, patients' quality adjusted life years, patients' medical costs, cost-effectiveness of the intervention, percentage of recommendations accepted by GPs, percentage of recommendation rejected by GPs and patients' willingness to have medications deprescribed.
","['outpatients from the Swiss primary care setting, aged ≥65 years with ≥three chronic medical conditions and concurrent use of ≥five chronic medications', 'Patients treated by the same general practitioner (GP) constitute a cluster, and clusters', 'older, multimorbid patients with polypharmacy']","['STRIPA', 'PharmacoTherapy', 'standard care sham intervention']","[""degree of polypharmacy, overprescribing and underprescribing, the number of falls and fractures, quality of life, the amount of formal and informal care received by patients, survival, patients' quality adjusted life years, patients' medical costs, cost-effectiveness of the intervention, percentage of recommendations accepted by GPs, percentage of recommendation rejected by GPs and patients' willingness to have medications deprescribed"", 'medication appropriateness, as measured jointly by the change in the Medication Appropriateness Index (MAI) and Assessment of Underutilisation (AOU']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0575126', 'cui_str': 'Falls occurrence'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0034380'}, {'cui': 'C3494177', 'cui_str': 'Informal care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C4047373', 'cui_str': 'Recommendation accepted'}, {'cui': 'C4319517', 'cui_str': 'Order rejected (qualifier value)'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.0932171,"Secondary endpoints include the degree of polypharmacy, overprescribing and underprescribing, the number of falls and fractures, quality of life, the amount of formal and informal care received by patients, survival, patients' quality adjusted life years, patients' medical costs, cost-effectiveness of the intervention, percentage of recommendations accepted by GPs, percentage of recommendation rejected by GPs and patients' willingness to have medications deprescribed.
","[{'ForeName': 'Katharina Tabea', 'Initials': 'KT', 'LastName': 'Jungo', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Zsofia', 'Initials': 'Z', 'LastName': 'Rozsnyai', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Mantelli', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Floriani', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Axel Lennart', 'Initials': 'AL', 'LastName': 'Löwe', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Lindemann', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Schwab', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Meier', 'Affiliation': 'Institute of Primary Care, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Lamia', 'Initials': 'L', 'LastName': 'Elloumi', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Corlina Johanna Alida', 'Initials': 'CJA', 'LastName': 'Huibers', 'Affiliation': 'Department of Geriatric Medicine, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Bastiaan Theodoor Gerard Marie', 'Initials': 'BTGM', 'LastName': 'Sallevelt', 'Affiliation': 'Department of Clinical Pharmacy, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Michiel C', 'Initials': 'MC', 'LastName': 'Meulendijk', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Reeve', 'Affiliation': 'Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Medical Sciences, Division of Health Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Schneider', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Bhend', 'Affiliation': 'Hausarzt Praxis Städtli Aarburg, Aarburg, Switzerland.'}, {'ForeName': 'Pius M', 'Initials': 'PM', 'LastName': 'Bürki', 'Affiliation': 'Berufsverband der Haus- und Kinderärztinnen Schweiz, Bern, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Trelle', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spruit', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwenkglenks', 'Affiliation': 'Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Streit', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland sven.streit@biham.unibe.ch.'}]",BMJ open,['10.1136/bmjopen-2019-031080']
413,31481571,Efficacy and safety of 1C class antiarrhythmic agent (propafenone) for supraventricular arrhythmias in septic shock compared to amiodarone: protocol of a prospective randomised double-blind study.,"INTRODUCTION


Supraventricular arrhythmias contribute to haemodynamic compromise in septic shock. A retrospective study generated the hypothesis that propafenone could be more effective than amiodarone in achieving and maintaining sinus rhythm (SR). Certain echocardiographic parameters may predict a successful cardioversion and help in the decision on rhythm or rate control strategy.
METHODS AND ANALYSIS


The trial includes septic shock patients with new-onset arrhythmia, but without severe impairment of the left ventricular ejection fraction. After baseline echocardiography, the patient is randomised to receive a bolus and maintenance dose of either amiodarone or propafenone. The primary outcome is the proportion of patients that have achieved rhythm control at 24 hours after the start of the infusion. The secondary outcomes are the percentages of patients that needed rescue treatments (DC cardioversion or unblinding and crossover of the antiarrhythmics), the recurrence of arrhythmias, intensive care unit mortality, 28-day and 1-year mortality. In the posthoc analysis, we separately assess subgroups of patients with pulmonary hypertension and right ventricular dysfunction. In the exploratory part of the study, we assess whether the presence of a transmitral diastolic A wave and its higher velocity-time integral is predictive for the sustainability of mechanical SR and whether the indexed left atrial endsystolic volume is predictive of recurrent arrhythmia. Considering that the restoration of SR within 24 hours occurred in 74% of the amiodarone-treated patients and in 89% of the patients treated with propafenone, we plan to include 200 patients to have an 80% chance to demonstrate the superiority of propafenone at p=0.05.
ETHICS AND DISSEMINATION


The trial is recruiting patients according to its second protocol version approved by the University Hospital Ethical Board on the 6 October 2017 (No. 1691/16S-IV). The results will be disseminated through peer reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


NCT03029169.",2019,"Considering that the restoration of SR within 24 hours occurred in 74% of the amiodarone-treated patients and in 89% of the patients treated with propafenone, we plan to include 200 patients to have an 80% chance to demonstrate the superiority of propafenone at p=0.05.
","['septic shock', 'septic shock patients with new-onset arrhythmia, but without severe impairment of the left ventricular ejection fraction', 'patients with pulmonary hypertension and right ventricular dysfunction']","['1C class antiarrhythmic agent (propafenone', 'amiodarone', 'propafenone', 'amiodarone or propafenone']","['proportion of patients that have achieved rhythm control', 'achieving and maintaining sinus rhythm (SR', 'percentages of patients that needed rescue treatments (DC cardioversion or unblinding and crossover of the antiarrhythmics), the recurrence of arrhythmias, intensive care unit mortality, 28-day and 1-year mortality']","[{'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0242707', 'cui_str': 'Right Ventricular Dysfunction'}]","[{'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0003195', 'cui_str': 'Anti-Arrhythmics'}, {'cui': 'C0033429', 'cui_str': 'Propafenone'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",200.0,0.14396,"Considering that the restoration of SR within 24 hours occurred in 74% of the amiodarone-treated patients and in 89% of the patients treated with propafenone, we plan to include 200 patients to have an 80% chance to demonstrate the superiority of propafenone at p=0.05.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Balik', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU martin.balik@vfn.cz.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Waldauf', 'Affiliation': 'Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University and Kralovske Vinohrady University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Maly', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Matousek', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Brozek', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rulisek', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Porizka', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sachl', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Otahal', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Brestovansky', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Svobodova', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Flaksa', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Zdenek', 'Initials': 'Z', 'LastName': 'Stach', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Pazout', 'Affiliation': 'Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University and Kralovske Vinohrady University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Frantisek', 'Initials': 'F', 'LastName': 'Duska', 'Affiliation': 'Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University and Kralovske Vinohrady University Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Smid', 'Affiliation': '2nd Department of Medicine, 1st Medical Faculty, Charles University and General Univeristy Hospital in Prague, Prague, Czech Republic, EU.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stritesky', 'Affiliation': 'Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU.'}]",BMJ open,['10.1136/bmjopen-2019-031678']
414,31180297,Treating Posttransplant Anemia With Erythropoietin Improves Quality of Life but Does Not Affect Progression of Chronic Kidney Disease.,"OBJECTIVES


Posttransplant anemia affects 30% to 45% of kidney transplant recipients and is associated with increased morbidity. However, there is lack of evidence about safe hemoglobin levels after erythropoietin treatment. Studies are needed to better understand the potential benefits and risks, as well as to define safe target hemoglobin ranges in these patients.
MATERIALS AND METHODS


In this single-center exploratory, open-label randomized controlled trial, kidney trans-plant recipients with anemia 3 months posttransplant were either treated with epoetin beta to a hemoglobin target level of 11.5 to 13.5 g/dL (n = 28) or given no treatment (n = 27). Treatment effects on graft function and health quality of life were assessed.
RESULTS


After 2 years, hemoglobin concentrations were significantly higher in the epoetin beta treatment group than in the no treatment group (12.3 ± 0.18 vs 9.99 ± 0.22 g/dL; P < .0001). Estimated glomerular filtration rate, calculated by Modified Diet in Renal Disease 7, declined by 1.7 mL/min (interquartile range, -6 to 4.24) in the epoetin treatment group and by 4.16 mL/min (interquartile range, -12.42 to 2.78) in the no treatment group (P = .32). Rate of progression, determined by estimated glomerular filtration rate slope, was not significantly different between groups (-0.09 ± 0.1 vs -0.12 ± 0.15 mL/min for treated vs not treated; P = .78). Moreover, we observed no significant differences in proteinuria and blood pressure. Treated patients had greater improvements in the vitality and mental health domains of the Medical Outcomes Short Form Health Survey quality of life scores.
CONCLUSIONS


Treatment of anemia in kidney transplant recipients to a hemoglobin level of 11.5 to 13.5 g/dL with erythropoietin improves some quality of life scores. The treatment was safe and not associated with adverse outcomes. There were no changes in rate of decline of graft function.",2020,"Rate of progression, determined by estimated glomerular filtration rate slope, was not significantly different between groups (-0.09 ± 0.1 vs -0.12 ± 0.15 mL/min for treated vs not treated; P = .78).","['kidney trans-plant recipients with anemia', 'kidney transplant recipients']","['Erythropoietin', 'erythropoietin']","['graft function and health quality of life', 'vitality and mental health domains of the Medical Outcomes Short Form Health Survey quality of life scores', 'quality of life scores', 'Quality of Life', 'glomerular filtration rate slope', 'proteinuria and blood pressure', 'Estimated glomerular filtration rate', 'hemoglobin concentrations', 'morbidity', 'rate of decline of graft function', 'Rate of progression']","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}]","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3811844'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.0518795,"Rate of progression, determined by estimated glomerular filtration rate slope, was not significantly different between groups (-0.09 ± 0.1 vs -0.12 ± 0.15 mL/min for treated vs not treated; P = .78).","[{'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Pile', 'Affiliation': 'From the Translational Medicine and Therapeutics, William Harvey Research Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Raftery', 'Affiliation': ''}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Thuraisingham', 'Affiliation': ''}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Kirwan', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Harwood', 'Affiliation': ''}, {'ForeName': 'Muhammed M', 'Initials': 'MM', 'LastName': 'Yaqoob', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2018.0283']
415,31182258,"Effect of an intensive functional rehabilitation program on the recovery of activities of daily living after total knee arthroplasty: A multicenter, randomized, controlled trial.","BACKGROUND


Postoperative exercise is effective for improving activities of daily living (ADL) in patients undergoing total knee arthroplasty (TKA), and exercise has been included in standard care after surgery provided in Japan. However, it is unknown whether standard care has room to develop for improving ADL. The goal of this study was to investigate the effect of an intensive functional rehabilitation (IFR) program in addition to standard care on the recovery of ADL following surgery.
METHODS


A total of 104 inpatients with knee osteoarthritis undergoing TKA were randomly assigned to either the experimental or the control group. The experimental group (n = 57) were given standard care and participated in the IFR program immediately after surgery (e.g., stand up and sit down, strengthen the knee extensor muscle, climbing onto a platform, and walking laterally). The control group (n = 47) were given standard care only. Primary outcomes were the score of Functional Independence Measure (FIM) and the Barthel Index (BI) at 2 weeks postoperatively. Matching using the propensity score was performed to control the influence of the patient characteristic on the outcome.
RESULTS


As a result of matching, 42 patients were extracted. The averages (standard deviation) of the FIM motor score were 79.0 (10.8) for the experimental group and 80.5 (9.4) for the control group. The BI scores were 88.1 (13.3) for the experimental group and 91.0 (10.1) for the control group. The experimental and control groups did not show significant intergroup differences in either score.
CONCLUSIONS


Our study shows that as compared to standard care, IFR program for 2 weeks in addition to standard care after surgery did not significantly improve ADL in patients undergoing TKA.",2020,A total of 104 inpatients with knee osteoarthritis undergoing TKA were randomly assigned to either the experimental or the control group.,"['42 patients were extracted', 'patients undergoing total knee arthroplasty (TKA', '104 inpatients with knee osteoarthritis undergoing TKA', 'after total knee arthroplasty', 'patients undergoing TKA']","['intensive functional rehabilitation (IFR) program', 'standard care and participated in the IFR program immediately after surgery (e.g., stand up and sit down, strengthen the knee extensor muscle, climbing onto a platform, and walking laterally', 'intensive functional rehabilitation program']","['score of Functional Independence Measure (FIM) and the Barthel Index (BI', 'BI scores', 'recovery of activities of daily living', 'FIM motor score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0454532', 'cui_str': 'Functional rehabilitation (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0444796', 'cui_str': 'Standing up (observable entity)'}, {'cui': 'C0560831', 'cui_str': 'Does sit down (finding)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0561942', 'cui_str': 'Does climb (finding)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",104.0,0.0428473,A total of 104 inpatients with knee osteoarthritis undergoing TKA were randomly assigned to either the experimental or the control group.,"[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima, Japan; Department of Rehabilitation, Hiroshima International University, Hiroshima, Japan. Electronic address: ryotana@hiroshima-u.ac.jp.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Hayashizaki', 'Affiliation': 'Department of Rehabilitation, Chūgokurōsai Hospital, Hiroshima, Japan.'}, {'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Rehabilitation, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Rehabilitation, Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Umehara', 'Affiliation': 'Department of Rehabilitation, Saiseikai Kure Hospital, Hiroshima, Japan.'}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2019.04.009']
416,30291016,Findings From a Randomized Trial of Weight Gain Prevention Among Overweight Puerto Rican Young Adults.,"OBJECTIVE


Assess impact of multimodality weight gain prevention intervention.
METHODS


Randomized clinical trial among 39 overweight young Puerto Rico college students using 10 weekly peer-support sessions promoting dietary, physical activity, and other lifestyle changes enhanced by stress-reduction and mindfulness approaches. Body mass index (BMI) and self-reported behaviors were measured at baseline and at 10 weeks and 6 months after baseline.
RESULTS


At the completion of the intervention, BMIs in the experimental arm were 0.8 units lower than at baseline (z = -3.0; P = .008) and 1.2 lower at 6 months after baseline (z = -4.1; P < .001); BMIs in the control arm were 0.7 higher (z = 2.7; P = .02) at 10 weeks and 0.8 higher at 6 months (z = 3.1; P = .005). Group × time interaction confirmed that BMI differed significantly over time between arms (χ 2  = 26.9; degrees of freedom = 2; P < .001). Analysis of behavioral changes was mostly inconclusive although the experimental arm reported a considerable increase in walking at 10 weeks. Qualitative data suggested that yoga and mindfulness components were particularly useful for motivating participants to maintain healthier lifestyle patterns.
CONCLUSIONS


Body mass index in the experimental arm decreased at the end of intervention and was maintained at 6 months' follow-up.",2019,"At the completion of the intervention, BMIs in the experimental arm were 0.8 units lower than at baseline (z = -3.0; P = .008) and 1.2 lower at 6 months after baseline (z = -4.1; P < .001); BMIs in the control arm were 0.7 higher (z = 2.7; P = .02) at 10 weeks and 0.8 higher at 6 months (z = 3.1; P = .005).","['39 overweight young Puerto Rico college students using 10 weekly', 'Overweight Puerto Rican Young Adults']","['peer-support sessions promoting dietary, physical activity, and other lifestyle changes enhanced by stress-reduction and mindfulness approaches', 'multimodality weight gain prevention intervention', 'Weight Gain Prevention']","['Body mass index (BMI) and self-reported behaviors', 'BMI', 'BMIs']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0034043', 'cui_str': 'Puerto Ricans'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",39.0,0.0863953,"At the completion of the intervention, BMIs in the experimental arm were 0.8 units lower than at baseline (z = -3.0; P = .008) and 1.2 lower at 6 months after baseline (z = -4.1; P < .001); BMIs in the control arm were 0.7 higher (z = 2.7; P = .02) at 10 weeks and 0.8 higher at 6 months (z = 3.1; P = .005).","[{'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Halperin', 'Affiliation': 'Department of Health Behavior, School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC; Robert Stempel College of Public Health and Social Work, Florida International University, FL. Electronic address: dhalpe@gmail.com.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Laux', 'Affiliation': 'North Carolina Translational and Clinical Sciences Institute, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'LeFranc-García', 'Affiliation': 'Sciences and Technology Department, Inter-American University of Puerto Rico, Ponce Campus, Ponce, Puerto Rico.'}, {'ForeName': 'Coloma', 'Initials': 'C', 'LastName': 'Araujo', 'Affiliation': 'Del Sur Farms, Ponce, Puerto Rico.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Robert Stempel College of Public Health and Social Work, Florida International University, FL.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.07.014']
417,32180294,"Herbal formulation ""turmeric extract, black pepper, and ginger"" versus Naproxen for chronic knee osteoarthritis: A randomized, double-blind, controlled clinical trial.","Osteoarthritis is the most common articular disease that can lead to chronic pain and severe disability. Curcumin-an effective ingredient in turmeric with anti inflammatory property-plays an important role in protecting the joints against destructive factors. Gingerols and piperine, are the effective ingredients of ginger and black pepper, which may potentially enhance and sustain the effect of curcumin in this direction. To determine the effect of cosupplementation with turmeric extract, black pepper, and ginger on prostaglandin E 2  (PGE 2  ) in patients with chronic knee osteoarthritis, compared with Naproxen. Sixty patients with two different levels of knee osteoarthritis (Grade 2 and 3) were studied. Individuals were randomly assigned to receive daily turmeric extract, ginger, and black pepper together or Naproxen capsule for 4 weeks. PGE 2  was evaluated by ELISA method. 24-hr recall was also assessed. All of participants completed the study. PGE 2  decreased significantly in both groups (p < .001), but there was no significant differences between groups. The results of this study indicated that intake of the selected herbs twice a day for 4 weeks may improve the PGE 2  levels in patients with chronic knee osteoarthritis similar to Naproxen drug.",2020,"PGE 2  decreased significantly in both groups (p < .001), but there was no significant differences between groups.","['chronic knee osteoarthritis', 'Sixty patients with two different levels of knee osteoarthritis (Grade 2 and 3) were studied', 'patients with chronic knee osteoarthritis similar to Naproxen drug', 'patients with chronic knee osteoarthritis']","['Herbal formulation ""turmeric extract, black pepper, and ginger"" versus Naproxen', 'daily turmeric extract, ginger, and black pepper together or Naproxen capsule', 'Naproxen', 'cosupplementation with turmeric extract, black pepper, and ginger on prostaglandin E 2  (PGE 2  ']","['24-hr recall', 'PGE 2']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0162750', 'cui_str': 'Black Pepper'}, {'cui': 'C1879327', 'cui_str': 'Zingiber officinale'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0033559', 'cui_str': 'PGE'}, {'cui': 'C0763149', 'cui_str': 'PG(6)E'}]","[{'cui': 'C0763149', 'cui_str': 'PG(6)E'}]",60.0,0.254991,"PGE 2  decreased significantly in both groups (p < .001), but there was no significant differences between groups.","[{'ForeName': 'Motahar', 'Initials': 'M', 'LastName': 'Heidari-Beni', 'Affiliation': 'Department of Pediatrics, Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir R', 'Initials': 'AR', 'LastName': 'Moravejolahkami', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pegah', 'Initials': 'P', 'LastName': 'Gorgian', 'Affiliation': 'Food Security Research Center, Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Food Security Research Center, Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad J', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Nimah', 'Initials': 'N', 'LastName': 'Bahreini-Esfahani', 'Affiliation': 'Food Security Research Center, Department of Community Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6671']
418,31064641,Effect of the EX-PLISSIT model on sexual function and sexual quality of life among women after hysterectomy: a randomised controlled trial.,"Background After hysterectomy, most patients experience psychological problems and sexual dysfunction that can affect their sexual quality of life (QOL). This study determined the effects of counselling based on the Extended Permission-Limited Information-Specific Suggestion-Intensive Therapy (EX-PLISSIT) model on sexual function and sexual QOL after hysterectomy among women attending hospitals in Sari, northern Iran.
METHODS


A randomised controlled trial was conducted between 2016 and 2017. Of 354 women undergoing hysterectomy, 80 women without anxiety, stress or depression who showed signs of sexual dysfunction were selected and, using blocked randomisation, were assigned to the intervention and control groups. The intervention group received two 1-h counselling sessions each week based on the EX-PLISSIT model. The control group received no counselling. Mood and sexual function and quality of life were measured using established tools (i.e. Depression, Anxiety and Stress Scale, Female Sexual Function Index (FSFI), and the Sexual Quality of Life - Female (SQOL-F)). Eight weeks after completion of counselling, outcomes were compared between the intervention and control groups using independent t-tests and Chi-squared, Mann-Whitney U, Wilcoxon, and Fisher tests.
RESULTS


There were no significant differences between the two groups in terms of demographics and most other outcome variables. However, there were significant differences between the intervention and control groups in terms of sexual functioning (median (interquartile range (IQR) FSFI score 32.45 (28.47-33.52) vs 23.85 (20.52-26.45) respectively) and sexual quality of life (median (IQR) SQOL-F score 107.50 (91-108) vs 87 (62.75-96.25), respectively) at the 8-week follow-up (P < 0.001 for both).
CONCLUSION


Use of the EX-PLISSIT model is recommended to sexual health care professionals.",2019,There were no significant differences between the two groups in terms of demographics and most other outcome variables.,"['women attending hospitals in Sari, northern Iran', '2016 and 2017', '354 women undergoing hysterectomy, 80 women without anxiety, stress or depression who showed signs of sexual dysfunction', 'women after hysterectomy']","['EX-PLISSIT model', 'counselling based on the Extended Permission-Limited Information-Specific Suggestion-Intensive Therapy (EX-PLISSIT) model']","['established tools (i.e. Depression, Anxiety and Stress Scale, Female Sexual Function Index (FSFI), and the Sexual Quality of Life - Female (SQOL-F', 'sexual function and sexual QOL', 'Mood and sexual function and quality of life', 'sexual functioning (median (interquartile range (IQR) FSFI score', 'sexual function and sexual quality of life', 'sexual quality of life (median (IQR) SQOL-F score', 'sexual quality of life (QOL']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0443055', 'cui_str': 'Sari - microbial strain (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034380'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",354.0,0.0748199,There were no significant differences between the two groups in terms of demographics and most other outcome variables.,"[{'ForeName': 'Marieh', 'Initials': 'M', 'LastName': 'Mahmoodi Dangesaraki', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Raziyeh', 'Initials': 'R', 'LastName': 'Maasoumi', 'Affiliation': 'Department of Reproductive Health, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran; and Nursing and Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Hamzehgardeshi', 'Affiliation': 'Sexual and Reproductive Health Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Roghieh', 'Initials': 'R', 'LastName': 'Kharaghani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran; and Corresponding author. Email: r.kharaghani@zums.ac.ir.'}]",Sexual health,['10.1071/SH18107']
419,32170359,Coronary collaterals in patients with ST-elevation myocardial infarction presenting late after symptom onset.,"BACKGROUND


The role of coronary collaterals in ST-elevation myocardial infarction (STEMI) remains controversial. So far, studies examining the effect of collaterals on outcome mainly focused on patients presenting early after symptom onset. We sought to investigate the prognostic influence of coronary collateralization in patients presenting with prolonged ischemia late after symptom onset.
METHODS AND RESULTS


The study is a subanalysis of a randomized trial addressing thrombus aspiration in STEMI patients presenting between 12 and 48 h after symptom onset with a follow-up period of a minimum of 4 years. A total of 95 patients with a Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 or 1 prior to percutaneous coronary intervention (PCI) were included in the analysis. Of these, 62 patients (65%) had none or poor coronary collateralization according to the Rentrop classification (Rentrop grade 0 or 1) compared to 33 (35%) with well-developed collateralization (Rentrop grade 2 or 3). In comparison, patients with well-developed collateralization had a smaller area of microvascular obstruction (2.1 ± 3.8 vs. 4.5 ± 4.9% of left ventriclular mass (%LV), p = 0.03) and infarct size (27.9 ± 11.7 vs. 34.8 ± 17.2% LV, p = 0.047) on magnetic resonance imaging. Further, mortality at 4-years follow-up was lower (6% Rentrop grade 2 or 3 vs. 25% Rentrop grade 0 or 1, p = 0.02). Poor collateralization was an independent predictor of long-term mortality on multivariate Cox regression analyses in addition to cardiogenic shock and unsuccessful PCI during the index procedure.
CONCLUSION


Sufficient coronary collateralization has a positive impact on microvascular obstruction, infarct size and long-term mortality in STEMI patients presenting between 12 and 48 h after symptom onset.",2020,"Poor collateralization was an independent predictor of long-term mortality on multivariate Cox regression analyses in addition to cardiogenic shock and unsuccessful PCI during the index procedure.
","['95 patients with a Thrombolysis', 'patients presenting with prolonged ischemia late after symptom onset', 'STEMI patients presenting between 12 and 48\xa0h after symptom onset', 'patients with ST-elevation myocardial infarction presenting late after symptom onset', 'STEMI patients presenting between 12 and 48\xa0h after symptom onset with a follow-up period of a minimum of 4\xa0years', '62 patients (65%) had none or poor coronary collateralization according to the Rentrop classification (Rentrop grade 0 or 1) compared to 33 (35%) with well-developed collateralization (Rentrop grade 2 or 3']",['percutaneous coronary intervention (PCI'],"['microvascular obstruction, infarct size and long-term mortality', 'mortality', 'microvascular obstruction', 'infarct size']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",95.0,0.0669405,"Poor collateralization was an independent predictor of long-term mortality on multivariate Cox regression analyses in addition to cardiogenic shock and unsuccessful PCI during the index procedure.
","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Freund', 'Affiliation': 'Heart Center Leipzig, Department of Internal Medicine/Cardiology, University of Leipzig, Strümpellstr. 39, 04289, Leipzig, Germany. anne.freund@medizin.uni-leipzig.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stiermaier', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Schock', 'Affiliation': 'Heart Center Leipzig, Department of Internal Medicine/Cardiology, University of Leipzig, Strümpellstr. 39, 04289, Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lurz', 'Affiliation': 'Heart Center Leipzig, Department of Internal Medicine/Cardiology, University of Leipzig, Strümpellstr. 39, 04289, Leipzig, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig, Department of Internal Medicine/Cardiology, University of Leipzig, Strümpellstr. 39, 04289, Leipzig, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig, Department of Internal Medicine/Cardiology, University of Leipzig, Strümpellstr. 39, 04289, Leipzig, Germany.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01625-w']
420,32179023,Cost and reimbursement of providing routine vaccines in outpatient obstetrician/gynecologist settings.,"OBJECTIVE


To determine the costs and reimbursement associated with running a vaccine program in 5 obstetrics/gynecology practices in Colorado that had participated in a 3-year randomized, controlled trial focused on increasing vaccination in this setting.
MATERIALS AND METHODS


This was a secondary analysis on costs from 5 clinics participating in a cluster-randomized controlled trial that assessed the effectiveness of a multimodal intervention to improve vaccination rates in outpatient obstetrics/gynecology clinics in central Colorado. The intervention included designation of an immunization champion within the practice, purchasing recommended vaccines for the practice, guidance on storage and management, implementing practices for routine identification of eligible patients for vaccination using the medical record, implementation of standing orders for vaccination, and vaccine administration to patients. Data on costs were gathered from office invoices, claims data, surveys and in-person observations during the course of the trial. These data incorporated supply and personnel costs for administering vaccines to individual patients that were derived from a combination of time-motion studies of staff and provider clinical activity, and practice reports, as well as costs related to maintaining the vaccination program at the practice level, which were derived from practice reports and invoices. Cost data for personnel time during visits in which vaccination was assessed and/or discussed, but no vaccine was given to the patient were also included in the main analysis. Data on practice revenue were derived from practice reimbursement records. All costs were described in 2014 dollars. The primary analysis was the proportion of costs for the program that were reimbursed, aggregated over all years of the study and combining all vaccines and practices, separated by obstetrics vs gynecology patients.
RESULTS


Collectively the 5 clinics served >40,000 patient during the study period and served a population that was 16% Medicaid. Over the 3-year observation period, there were 6573 vaccination claims made collectively by the practices (4657 for obstetric patients, 1916 for gynecology patients). The most expensive component of the program was the material costs of the vaccines themselves, which ranged from a low of $9.67 for influenza vaccines, to a high of $141.40 for human papillomavirus vaccine. Staff costs for assessing and delivering vaccines during patient visits were minimal ($0.09-$1.24 per patient visit depending on the practice and whether an obstetrics or gynecology visit was being assessed) compared with staff costs for maintaining the program at a practice level (ie, assessing inventory, ordering and stocking vaccines; $0.89-$105.89 per vaccine dose given). When assessing all costs compared with all reimbursement, we found that vaccines for obstetrics patients were reimbursed at 159% of the costs over the study period, and for gynecology patients at 97% of the costs. Overall, the vaccination program was financially favorable across the practices, averaging 125% reimbursement of costs across the three study years.
CONCLUSION


Providing routine vaccines to patients in the ambulatory obstetrics/gynecology setting is generally not financially prohibitive for practices, and may even be financially beneficial, though there is variability between practices that can affect the overall reimbursement margin.",2020,"Overall, the vaccination program was financially favorable across the practices, averaging 125% reimbursement of costs across the three study years.
","['patients in the ambulatory obstetrics/gynecology setting', 'Outpatient Obstetrician/Gynecologist Settings', 'Collectively the 5 clinics served >40,000 patient during the study period and served a population that was 16% Medicaid', 'five obstetrics/gynecology (Ob/Gyn) practices in Colorado that had participated', 'outpatient Ob/Gyn clinics in central Colorado']","['running a vaccine program', 'multimodal intervention']","['Staff costs', 'proportion of costs', 'vaccination rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0334897', 'cui_str': 'Obstetrician (occupation)'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist (occupation)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.0585529,"Overall, the vaccination program was financially favorable across the practices, averaging 125% reimbursement of costs across the three study years.
","[{'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver; Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver. Electronic address: Amanda.dempsey@cuanschutz.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'School of Pharmacy, University of Colorado Denver.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brewer', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Sevick', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Pediatrics, University of Colorado Denver; Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.02.051']
421,32118753,Shi's Yi-Qi Bu-Shen Tong-Luo decoction combined with manipulation in the management of wrist stiffness after distal radius fracture: Study protocol clinical trial (SPIRIT Compliant).,"INTRODUCTION


Wrist stiffness is a common sequela of distal radial fractures. Manipulation is generally used and effective, but problems exist, such as intense pain, swelling during the process of manipulation and long treatment period. Therefore, a combinative therapeutic strategy is necessary to benefit rehabilitation after distal radius fracture. Shi's Yi-Qi Bu-Shen Tong-Luo decoction (BTD) combined with wrist manipulation has been used in the Shanghai Ninth People's Hospital Huangpu Branch in last few decades. BTD has potential therapeutic effects on rehabilitation after distal radius fracture, which should be evaluated by rigorous clinical trial.
METHODS/DESIGN


A randomized, double-blind, placebo-controlled clinical trial will be conducted to determine the efficiency of BTD in relief of wrist stiffness and pain and function rehabilitation. A total of 80 wrist stiffness patients with or without pain and edema will be enrolled, and treated with wrist manipulation plus BTD or placebo for 4 weeks. The primary outcome measure is the Cooney wrist score. The second outcome measures include pain numerical rating scale, patient rated wrist evaluation, 36-item short form health survey questionnaire, and side effects.
DISCUSSION


Although BTD has shown effects on rehabilitation after distal radius fracture in the Shanghai Ninth People's Hospital Huangpu Branch for decades, the universality of this efficacy needs evaluated. The results of this trial will provide a convincing evidence.
TRIAL REGISTRATION


ChiCTR2000029260, January 19, 2020.",2020,"Although BTD has shown effects on rehabilitation after distal radius fracture in the Shanghai Ninth People's Hospital Huangpu Branch for decades, the universality of this efficacy needs evaluated.","['wrist stiffness after distal radius fracture', '80 wrist stiffness patients with or without pain and edema']","['placebo', 'BTD', 'Qi Bu-Shen Tong-Luo decoction (BTD) combined with wrist manipulation', 'wrist manipulation plus BTD or placebo', 'Qi Bu-Shen Tong-Luo decoction combined with manipulation']","['pain numerical rating scale, patient rated wrist evaluation, 36-item short form health survey questionnaire, and side effects', 'Cooney wrist score', 'efficiency of BTD in relief of wrist stiffness and pain and function rehabilitation']","[{'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0183964', 'cui_str': 'Tong'}, {'cui': 'C0337841', 'cui_str': 'Luo (ethnic group)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1293270', 'cui_str': 'Wrist manipulation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]",80.0,0.216689,"Although BTD has shown effects on rehabilitation after distal radius fracture in the Shanghai Ninth People's Hospital Huangpu Branch for decades, the universality of this efficacy needs evaluated.","[{'ForeName': 'Hai-Yang', 'Initials': 'HY', 'LastName': 'Wu', 'Affiliation': ""Huangpu Branch, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University.""}, {'ForeName': 'Yi-Ru', 'Initials': 'YR', 'LastName': 'Wang', 'Affiliation': 'Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Gui', 'Affiliation': ""Huangpu Branch, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University.""}, {'ForeName': 'Guo-Wei', 'Initials': 'GW', 'LastName': 'Wen', 'Affiliation': ""Huangpu Branch, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University.""}, {'ForeName': 'Zhen-Yin', 'Initials': 'ZY', 'LastName': 'Tang', 'Affiliation': ""Huangpu Branch, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jun-Hao', 'Initials': 'JH', 'LastName': 'Wu', 'Affiliation': ""Huangpu Branch, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University.""}]",Medicine,['10.1097/MD.0000000000019308']
422,32118759,Randomized controlled trial for the efficacy of electroacupuncture in the treatment of urge urinary incontinence: A clinical study protocol.,"BACKGROUND


Despite that the urge urinary incontinence (UUI) is a nonfatal disease, it can lead to anxiety, embarrassment and depression to the patient. UUI is a common public health problem that can significantly affect the quality of life of the patient. Several conservative treatments have been recommended for the treatment of UUI; however, their efficiency remains unclear, leaving the disease without a real effective treatment. The clinical application of acupuncture to treat UUI is currently considered an effective approach despite the limited evidence that support its efficiency. The aim of this study is to assess the efficacy and safety of electroacupuncture therapy in the treatment of UUI.
METHODS AND ANALYSIS


A randomized, parallel, controlled study will be performed. Patients with UUI treated with electroacupuncture group (EA) will compare with the sham-treated sham EA (SA) patients. A total of 100 participants with UUI will be randomly allocated to either the EA or the SA group with a 1:1 ratio. The treatment of UUI patients will performed 3 times per week, for 8 weeks in 30-minute sessions. At the end of the treatment the patients will be followed-up until week 32. The primary outcomes include scores of incontinence questionnaire-short form, the average 24-hour urgency incontinence episodes, and the average 24-hour urge episodes responses from baseline until the 4th, 8th , 24th, and 32nd week. The secondary outcomes included the average 24-hour urine volume and the average 24-hour micturition frequency responses from baseline until the 8th and 32nd week, as well as the change in incontinence quality of life scores from baseline at the 8th and 32nd week. In addition, the degree of satisfaction of the participants undergoing acupuncture treatment will be measured at the 4th and 8th week. The participants' clinical acupuncture expectations were evaluated at baseline, and the questionnaire for urinary incontinence diagnosis was used to identify stress incontinence, mixed urinary incontinence, and urge incontinence at baseline.
DISCUSSION


This is a randomized, controlled, observer-blinded trial of electroacupuncture treatment for UUI. The results of this trial will provide more evidence on whether electroacupuncture is efficacious for treating UUI.",2020,A total of 100 participants with UUI will be randomly allocated to either the EA or the SA group with a 1:1 ratio.,"['Patients with UUI treated with', 'urge urinary incontinence', '100 participants with UUI']","['acupuncture', 'electroacupuncture', 'EA', 'electroacupuncture group (EA', 'electroacupuncture therapy', 'sham-treated sham EA (SA']","['average 24-hour urine volume and the average 24-hour micturition frequency responses', 'incontinence quality of life scores', 'efficacy and safety', 'scores of incontinence questionnaire-short form, the average 24-hour urgency incontinence episodes, and the average 24-hour urge episodes responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0150045', 'cui_str': 'Urinary Reflex Incontinence'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0729389', 'cui_str': '24 hour urine volume - finding'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination (finding)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",100.0,0.0786618,A total of 100 participants with UUI will be randomly allocated to either the EA or the SA group with a 1:1 ratio.,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine.'}, {'ForeName': 'Shuangjin', 'Initials': 'S', 'LastName': 'Qi', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine.'}, {'ForeName': 'Xianming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhi', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine.'}, {'ForeName': 'Miaoxian', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Mo', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000019315']
423,31446416,"Motivating Structured walking Activity in people with Intermittent Claudication (MOSAIC): protocol for a randomised controlled trial of a physiotherapist-led, behavioural change intervention versus usual care in adults with intermittent claudication.","INTRODUCTION


Walking exercise is a recommended but underused treatment for intermittent claudication caused by peripheral arterial disease (PAD). Addressing the factors that influence walking exercise may increase patient uptake of and adherence to recommended walking. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of a physiotherapist-led behavioural change intervention on walking ability in adults with intermittent claudication (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in comparison with usual care.
METHODS AND ANALYSIS


The MOSAIC trial is a two-arm, parallel-group, single-blind RCT. 192 adults will be recruited from six National Health Service Hospital Trusts. Inclusion criteria are: aged ≥50 years, PAD (Ankle Brachial Pressure Index ≤0.90, radiographic evidence or clinician report) and intermittent claudication (San Diego Claudication Questionnaire), being able and willing to participate and provide informed consent. The primary outcome is walking ability (6 min walking distance) at 3 months. Outcomes will be obtained at baseline, 3 and 6 months by an assessor blind to group allocation. Participants will be individually randomised (n=96/group, stratified by centre) to receive either MOSAIC or usual care by an independent randomisation service. Estimates of treatment effects will use an intention-to-treat framework implemented using multiple regression adjusted for baseline values and centre.
ETHICS AND DISSEMINATION


This trial has full ethical approval (London-Bloomsbury Research Ethics Committee (17/LO/0568)). It will be disseminated via patient forums, peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


ISRCTN14501418.",2019,"Participants will be individually randomised (n=96/group, stratified by centre) to receive either MOSAIC or usual care by an independent randomisation service.","['adults with intermittent claudication', 'Inclusion criteria are: aged ≥50 years, PAD (Ankle Brachial Pressure Index ≤0.90, radiographic evidence or clinician report) and intermittent claudication (San Diego Claudication Questionnaire), being able and willing to participate and provide informed consent', '192 adults will be recruited from six National Health Service Hospital Trusts', 'people with Intermittent Claudication (MOSAIC', 'adults with intermittent claudication (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC']","['Walking exercise', 'physiotherapist-led, behavioural change intervention versus usual care', 'physiotherapist-led behavioural change intervention', 'MOSAIC or usual care by an independent randomisation service']","['walking ability', 'walking ability (6\u2009min walking distance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1276055', 'cui_str': 'ABPI - Ankle brachial pressure index'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",192.0,0.415373,"Participants will be individually randomised (n=96/group, stratified by centre) to receive either MOSAIC or usual care by an independent randomisation service.","[{'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Bearne', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK lindsay.bearne@kcl.ac.uk.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Galea Holmes', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bieles', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Eddy', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Fisher', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Modarai', 'Affiliation': ""Academic Department of Vascular Surgery, King's College London, London, UK.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': ""Department of Vascular Surgery, Guy's and St Thomas NHS Foundation Trust, London, UK.""}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Peacock', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sackley', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK.""}, {'ForeName': 'Brittannia', 'Initials': 'B', 'LastName': 'Volkmer', 'Affiliation': ""Department of Population Health Sciences, King's College London, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Weinman', 'Affiliation': 'Institute of Pharmaceutical Sciences, Kings College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030002']
424,32065827,Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial.,"Importance


Intraoperative hypotension is associated with increased morbidity and mortality. A machine learning-derived early warning system to predict hypotension shortly before it occurs has been developed and validated.
Objective


To test whether the clinical application of the early warning system in combination with a hemodynamic diagnostic guidance and treatment protocol reduces intraoperative hypotension.
Design, Setting, and Participants


Preliminary unblinded randomized clinical trial performed in a tertiary center in Amsterdam, the Netherlands, among adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019. Hypotension was defined as a mean arterial pressure (MAP) below 65 mm Hg for at least 1 minute.
Interventions


Patients were randomly assigned to receive either the early warning system (n = 34) or standard care (n = 34), with a goal MAP of at least 65 mm Hg in both groups.
Main Outcomes and Measures


The primary outcome was time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury. This was calculated as the depth of hypotension below a MAP of 65 mm Hg (in millimeters of mercury) × time spent below a MAP of 65 mm Hg (in minutes) divided by total duration of operation (in minutes).
Results


Among 68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women). The median length of surgery was 256 minutes (IQR, 213-430 minutes). The median time-weighted average of hypotension was 0.10 mm Hg (IQR, 0.01-0.43 mm Hg) in the intervention group vs 0.44 mm Hg (IQR, 0.23-0.72 mm Hg) in the control group, for a median difference of 0.38 mm Hg (95% CI, 0.14-0.43 mm Hg; P = .001). The median time of hypotension per patient was 8.0 minutes (IQR, 1.33-26.00 minutes) in the intervention group vs 32.7 minutes (IQR, 11.5-59.7 minutes) in the control group, for a median difference of 16.7 minutes (95% CI, 7.7-31.0 minutes; P < .001). In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
Conclusions and Relevance


In this single-center preliminary study of patients undergoing elective noncardiac surgery, the use of a machine learning-derived early warning system compared with standard care resulted in less intraoperative hypotension. Further research with larger study populations in diverse settings is needed to understand the effect on additional patient outcomes and to fully assess safety and generalizability.
Trial Registration


ClinicalTrials.gov Identifier: NCT03376347.",2020,"In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
","['adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019', 'During Elective Noncardiac Surgery', '68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women', 'patients undergoing elective noncardiac surgery']","['early warning system (n\u2009=\u200934) or standard care', 'Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care', 'machine learning-derived early warning system compared with standard care']","['median time of hypotension', 'mean arterial pressure (MAP', 'intraoperative hypotension', 'time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury', 'median length of surgery', 'Hypotension', 'median time-weighted average of hypotension', '0 serious adverse events resulting in death', 'morbidity and mortality', 'Depth and Duration of Intraoperative Hypotension']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1270999', 'cui_str': 'Invasive blood pressure (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517362', 'cui_str': 'Hypotension during surgery (disorder)'}, {'cui': 'C1519795', 'cui_str': 'Unit of measure (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",68.0,0.308548,"In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
","[{'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Wijnberge', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart F', 'Initials': 'BF', 'LastName': 'Geerts', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'Hol', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Lemmers', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Marijn P', 'Initials': 'MP', 'LastName': 'Mulder', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berge', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Schenk', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Lotte E', 'Initials': 'LE', 'LastName': 'Terwindt', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Vlaar', 'Affiliation': 'Department of Intensive Care, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Denise P', 'Initials': 'DP', 'LastName': 'Veelo', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}]",JAMA,['10.1001/jama.2020.0592']
425,31538976,"Guided Imagery: Reducing Anxiety, Depression, and Selected Side Effects Associated With Chemotherapy.","BACKGROUND


Cancer treatment can be a great source of anxiety and depression for patients. Patients who experience anxiety and depression may be treated with a variety of nonpharmacologic treatments, such as guided imagery.
OBJECTIVES


The purpose of this article is to determine the effect of guided imagery on patients' anxiety, depression, and other selected side effects prompted by chemotherapy.
METHODS


This pre- and postintervention assessment randomly selected patients with various types of cancer who were undergoing chemotherapy to listen to a guided imagery audio file for 20 minutes per day for one week. Data collection included a demographic questionnaire, the Hospital Anxiety and Depression Scale, and the Symptom Distress Scale.
FINDINGS


A significant decrease in anxiety and depression was noted in the intervention group compared to the control group. No reduction in the mean score for anxiety and depression was observed postintervention for the control group. In addition, patients in the intervention group showed improvement in all side effect categories. Patients in the intervention group reported the greatest rate of improvement in the items of pain, insomnia, appetite, and nausea.",2019,"Patients in the intervention group reported the greatest rate of improvement in the items of pain, insomnia, appetite, and nausea.",['patients with various types of cancer who were undergoing'],"['Guided Imagery', 'chemotherapy to listen to a guided imagery audio file', 'Chemotherapy', 'guided imagery']","['Reducing Anxiety, Depression, and Selected Side Effects', 'demographic questionnaire, the Hospital Anxiety and Depression Scale, and the Symptom Distress Scale.\nFINDINGS', 'mean score for anxiety and depression', 'side effect categories', 'greatest rate of improvement in the items of pain, insomnia, appetite, and nausea', 'anxiety and depression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}]","[{'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.0233884,"Patients in the intervention group reported the greatest rate of improvement in the items of pain, insomnia, appetite, and nausea.","[{'ForeName': 'Mohammad J', 'Initials': 'MJ', 'LastName': 'Mahdizadeh', 'Affiliation': 'Kerman University of Medical Sciences.'}, {'ForeName': 'Batool', 'Initials': 'B', 'LastName': 'Tirgari', 'Affiliation': 'Kerman University of Medical Sciences.'}, {'ForeName': 'Om S R R', 'Initials': 'OSRR', 'LastName': 'Abadi', 'Affiliation': 'Kerman University of Medical Sciences.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Bahaadinbeigy', 'Affiliation': 'Kerman University of Medical Sciences.'}]",Clinical journal of oncology nursing,['10.1188/19.CJON.E87-E92']
426,32172681,Examining the effects of mindfulness-based yoga instruction on positive embodiment and affective responses.,"Empirical evidence provides support for the inclusion of yoga as part of eating disorder prevention efforts through its positive impact on positive embodiment and experience of positive core affect. However, there is a need to identify the specific instructional strategies that will more consistently support positive embodiment and positive affect. We examined the effect of teaching a single yoga class using mindfulness-based instruction compared to appearance-based and neutral instruction alternatives on embodiment (i.e., state body surveillance, state body appreciation, pleasure during yoga) and changes in affect from before to after class. Female participants ( N  = 62;  M   age  = 23.89,  SD  = 6.86) were randomly assigned to a yoga class that emphasized: being mindfully present in one's body, changing one's appearance, or just getting into yoga poses. ANOVAs revealed significantly higher body surveillance (η p   2  =.10) and lower forecasted pleasure (η p   2  =.21) in the appearance class compared to the other two classes. Participants in the mindfulness class experienced greater improvement in affect (η p   2  =.08) from before to after class and higher remembered pleasure during the yoga class (η p   2  =.19) compared to those in the appearance class. Emphasizing changes to appearance in yoga instruction may place participants at risk for less positive affect and less positive experiences of embodiment compared to mindfulness-based or even neutral yoga instruction.",2020,Participants in the mindfulness class experienced greater improvement in affect (η p 2  =.08) from before to after class and higher remembered pleasure during the yoga class (η p 2  =.19) compared to those in the appearance class.,"['Female participants ( N  =\xa062;  M age \xa0=\xa023.89,  SD \xa0=\xa06.86']","['mindfulness-based yoga instruction', ""yoga class that emphasized: being mindfully present in one's body, changing one's appearance, or just getting into yoga poses""]","['body surveillance', 'forecasted pleasure', 'positive embodiment and affective responses']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}]","[{'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",,0.0146212,Participants in the mindfulness class experienced greater improvement in affect (η p 2  =.08) from before to after class and higher remembered pleasure during the yoga class (η p 2  =.19) compared to those in the appearance class.,"[{'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Cox', 'Affiliation': 'Department of Kinesiology & Educational Psychology, Washington State University , Pullman, Washington, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ullrich-French', 'Affiliation': 'Department of Kinesiology & Educational Psychology, Washington State University , Pullman, Washington, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cook-Cottone', 'Affiliation': 'Counseling, School, and Educational Psychology, State University of New York at Buffalo , Buffalo, New York, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Tylka', 'Affiliation': 'Department of Psychology, The Ohio State University , Columbus, Ohio, USA.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Neumark-Sztainer', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota , Minneapolis, Minnesota, USA.'}]",Eating disorders,['10.1080/10640266.2020.1738909']
427,30580490,Effect of activated carbon nanoparticles on lymph node harvest in patients with colorectal cancer.,"AIM


The aim was to examine the effect of activated carbon nanoparticles (ACNs) on lymph node retrieval in colorectal cancer (CRC) patients.
METHODS


This prospective randomized study of 80 subjects was performed between March 2016 and December 2016. Eighty patients with CRC were randomly divided into two groups, the ACN group and a control group. The patients in the ACN group were subjected to 1 ml of ACN injection in the subserosa around the tumour before colectomy and D3 lymphadenectomy. The patients in the control group received the same procedure without the injection of ACNs. After surgery, lymph nodes were isolated, and the greatest dimensions were measured by the same pathologist.
RESULTS


The average number of lymph nodes harvested from each patient was markedly more in the ACN group (31.3 ± 8.1) than in the control group (21.9 ± 5.3; P < 0.001), and the average number of lymph nodes less than 5 mm in greatest dimension was significantly more in the ACN group (11.9 ± 4.9) than in the control group (4.1 ± 2.4; P < 0.001). The ACN group (15/40) had a higher rate of Stage III patients compared to the control group (6/39; P = 0.026). Besides, the greatest dimension of 32.8% metastatic lymph nodes was less than 5 mm.
CONCLUSION


There is significant upstaging following the use of ACNs, which could find more involved nodes. Therefore, ACNs can be used as a tracer to harvest more lymph nodes in CRC patients, with improvement in the accuracy of pathological staging.",2019,The ACN group (15/40) had a higher rate of Stage III patients compared to the control group (6/39; P = 0.026).,"['colorectal cancer (CRC) patients', 'patients with colorectal cancer', 'Eighty patients with CRC', '80 subjects was performed between March 2016 and December 2016']","['activated carbon nanoparticles', 'same procedure without the injection of ACNs', 'ACN', 'ACN injection in the subserosa around the tumour before colectomy and D3 lymphadenectomy', 'activated carbon nanoparticles (ACNs']",['average number of lymph nodes'],"[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0001275', 'cui_str': 'medicinal charcoal'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0249643', 'cui_str': 'ACN'}, {'cui': 'C0225334', 'cui_str': 'Subserosa (body structure)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0009274', 'cui_str': 'Large Bowel Resection'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}]",80.0,0.0182659,The ACN group (15/40) had a higher rate of Stage III patients compared to the control group (6/39; P = 0.026).,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Colorectal Cancer, Key Laboratory of Cancer Prevention and Therapy, and National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Pathology, Key Laboratory of Cancer Prevention and Therapy, and National Clinical Research Center of Cancer, Cancer Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Colorectal Cancer, Key Laboratory of Cancer Prevention and Therapy, and National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': 'Department of Colorectal Cancer, Key Laboratory of Cancer Prevention and Therapy, and National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.14538']
428,32172314,Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study.,"PURPOSE


Drainage is a common procedure in high tibial osteotomy (HTO), but the benefits of drainage during HTO remain poorly investigated. This study was designed to investigate the effect of drainage on blood loss and early functional recovery in HTO.
METHODS


Altogether, 80 patients undergoing HTO were analyzed from August 2018 to September 2019. Patients were randomized into two groups: group A (drainage, n = 40) and group B (no drainage, n = 40). There were no intergroup differences in baseline parameters between the two groups, and the same surgical techniques and haemostatic methods were used. The mean follow-up time was 3.2 months. Blood loss and early functional recovery of the knee were examined post-operatively in both groups.
RESULTS


The total post-operative blood loss was 253.34 ± 104.18 ml in group A and 222.51 ± 106.89 ml in group B. This difference was non-significant (p > 0.05). The post-operative haemoglobin and haematocrit differences between groups were also non-significant (p > 0.05). Post-operative visual analogue scale (VAS) pain scores and lower leg swelling were lower in group A than those in group B (p < 0.05), and the early range of motion of the knee joint was higher in group A than that in group B (p < 0.05). Group A had lower incidence rates of dressing seepage and incision complications than group B (p < 0.05). The differences in three month post-operative VAS and knee function scores were non-significant (p > 0.05).
CONCLUSION


Drainage in HTO does not increase patients' total blood loss, but it can promote early knee function recovery by reducing post-operative pain, lower leg swelling, and the incidence of incision complications.
TRIAL REGISTRATION


NCT-03954860.",2020,Group A had lower incidence rates of dressing seepage and incision complications than group B (p < 0.05).,"['high tibial osteotomy (HTO', 'high tibial osteotomy', '80 patients undergoing HTO were analyzed from August 2018 to September 2019']",[],"['operative VAS and knee function scores', 'Post-operative visual analogue scale (VAS) pain scores and lower leg swelling', 'early range of motion of the knee joint', 'total blood loss', 'blood loss and early functional recovery', 'incidence rates of dressing seepage and incision complications', 'Drainage relieves pain', 'total post-operative blood loss', 'Blood loss and early functional recovery of the knee']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C1140621', 'cui_str': 'Leg'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",80.0,0.0708681,Group A had lower incidence rates of dressing seepage and incision complications than group B (p < 0.05).,"[{'ForeName': 'Songlin', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, Laoling Hospital of traditional Chinese Medicine, Dezhou, Shandong, China.'}, {'ForeName': 'Christiaan', 'Initials': 'C', 'LastName': 'Watson', 'Affiliation': 'Shandong University Cheeloo College of Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Qunshan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Desu', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Peilai', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Qilu Hospital of Shandong University, Jinan, Shandong, China. 15634057227@163.com.'}]",International orthopaedics,['10.1007/s00264-020-04530-z']
429,32050695,Seven Weeks of Jump Training with Superimposed Whole-Body Electromyostimulation Does Not Affect the Physiological and Cellular Parameters of Endurance Performance in Amateur Soccer Players.,"Intramuscular density of monocarboxylate-transporter (MCT) could affect the ability to perform high amounts of fast and explosive actions during a soccer game. MCTs have been proven to be essential for lactate shuttling and pH regulation during exercise and can undergo notable adaptational changes depending on training. The aim of this study was to evaluate the occurrence and direction of potential effects of a 7-weeks training period of jumps with superimposed whole-body electromyostimulation on soccer relevant performance surrogates and MCT density in soccer players. For this purpose, 30 amateur soccer players were randomly assigned to three groups. One group performed dynamic whole-body strength training including 3 x 10 squat jumps with WB-EMS (EG,  n  = 10) twice a week in addition to their daily soccer training routine. A jump training group (TG,  n  = 10) performed the same training routine without EMS, whereas a control group (CG,  n  = 8) merely performed their daily soccer routine. 2 (Time: pre vs. post) x 3 (group: EG, TG, CG) repeated measures analyses of variance (rANOVA) revealed neither a significant time, group nor interaction effect for VO 2 peak, Total Time to Exhaustion and La max  as well as MCT-1 density. Due to a lack of task-specificity of the underlying training stimuli, we conclude that seven weeks of WB-EMS superimposed to jump exercise twice a week does not relevantly influence aerobic performance or MCT density.",2020,"x 3 (group: EG, TG, CG) repeated measures analyses of variance (rANOVA) revealed neither a significant time, group nor interaction effect for VO 2 peak, Total Time to Exhaustion and La max  as well as MCT-1 density.","['soccer players', '30 amateur soccer players', 'Amateur Soccer Players']","['Jump Training with Superimposed Whole-Body Electromyostimulation', '7-weeks training period of jumps with superimposed whole-body electromyostimulation', 'dynamic whole-body strength training including 3 x 10 squat jumps with WB-EMS (EG,  n  = 10) twice a week in addition to their daily soccer training routine', 'jump training group (TG,  n  = 10) performed the same training routine without EMS, whereas a control group (CG,  n  = 8) merely performed their daily soccer routine', 'monocarboxylate-transporter (MCT']","['aerobic performance or MCT density', 'interaction effect for VO 2 peak, Total Time to Exhaustion and La max  as well as MCT-1 density']","[{'cui': 'C0037393', 'cui_str': 'Soccers'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2316841', 'cui_str': 'Monocarboxylate'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}]","[{'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0171305,"x 3 (group: EG, TG, CG) repeated measures analyses of variance (rANOVA) revealed neither a significant time, group nor interaction effect for VO 2 peak, Total Time to Exhaustion and La max  as well as MCT-1 density.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Wirtz', 'Affiliation': 'Institute of Training Science and Sport Informatics, Department of Intervention Research in Exercise Training, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Filipovic', 'Affiliation': 'Institute of Cardiology and Sports Medicine, Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Gehlert', 'Affiliation': 'Institute of Cardiology and Sports Medicine, Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Markus de', 'Initials': 'M', 'LastName': 'Marées', 'Affiliation': 'Section of Sports Medicine and Sports Nutrition, Faculty of Sports Science, Ruhr University of Bochum, 44801 Bochum, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Schiffer', 'Affiliation': 'Outpatient Clinic for Sports Traumatology and Public Health Consultation, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Institute of Cardiology and Sports Medicine, Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Donath', 'Affiliation': 'Institute of Training Science and Sport Informatics, Department of Intervention Research in Exercise Training, German Sport University Cologne, 50933 Cologne, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17031123']
430,32053149,HSD3B1 Genotype and Clinical Outcomes in Metastatic Castration-Sensitive Prostate Cancer.,"Importance


The adrenal-restrictive HSD3B1(1245A) allele limits extragonadal dihydrotestosterone synthesis, whereas the adrenal-permissive HSD3B1(1245C) allele augments extragonadal dihydrotestosterone synthesis. Retrospective studies have suggested an association between the adrenal-permissive allele, the frequency of which is highest in white men, and early development of castration-resistant prostate cancer (CRPC).
Objective


To examine the association between the adrenal-permissive HSD3B1(1245C) allele and early development of CRPC using prospective data.
Design, Setting, and Participants


The E3805 Chemohormonal Therapy vs Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) was a large, multicenter, phase 3 trial of castration with or without docetaxel treatment in men with newly diagnosed metastatic prostate cancer. From July 28, 2006, through December 31, 2012, 790 patients underwent randomization, of whom 527 had available DNA samples. In this study, the HSD3B1 germline genotype was retrospectively determined in 475 white men treated in E3805 CHAARTED, and clinical outcomes were analyzed by genotype. Data analysis was performed from July 28, 2006, to October 17, 2018.
Interventions


Men were randomized to castration plus docetaxel, 75 mg/m2, every 3 weeks for 6 cycles or castration alone.
Main Outcomes and Measures


Two-year freedom from CRPC and 5-year overall survival, with results stratified by disease volume. Patients were combined across study arms according to genotype to assess the overall outcome associated with genotype. Secondary analyses by treatment arm evaluated whether the docetaxel outcome varied with genotype.
Results


Of 475 white men with DNA samples, 270 patients (56.8%) inherited the adrenal-permissive genotype (≥1 HSD3B1[1245C] allele). Mean (SD) age was 63 (8.7) years. Freedom from CRPC at 2 years was diminished in men with low-volume disease with the adrenal-permissive vs adrenal-restrictive genotype: 51.0% (95% CI, 40.9%-61.2%) vs 70.5% (95% CI, 60.0%-80.9%) (P = .01). Overall survival at 5 years was also worse in men with low-volume disease with the adrenal-permissive genotype: 57.5% (95% CI, 47.4%-67.7%) vs 70.8% (95% CI, 60.3%-81.3%) (P = .03). Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death. There was no association between genotype and outcomes in men with high-volume disease. There was no interaction between genotype and benefit from docetaxel.
Conclusions and Relevance


Inheritance of the adrenal-permissive HSD3B1 genotype is associated with earlier castration resistance and shorter overall survival in men with low-volume metastatic prostate cancer and may help identify men more likely to benefit from escalated androgen receptor axis inhibition beyond gonadal testosterone suppression.",2020,"Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death.","['Mean (SD) age was 63 (8.7) years', 'men with newly diagnosed metastatic prostate cancer', '475 white men with DNA samples, 270 patients (56.8%) inherited the adrenal-permissive genotype (≥1 HSD3B1[1245C] allele', 'From July 28, 2006, through December 31, 2012, 790 patients underwent randomization, of whom 527 had available DNA samples', 'men with high-volume disease', 'men with low-volume metastatic prostate cancer', 'Interventions\n\n\nMen', '475 white men treated in E3805 CHAARTED, and clinical outcomes were analyzed by genotype', 'Metastatic Castration-Sensitive Prostate Cancer']","['castration alone', 'castration with or without docetaxel treatment', 'castration plus docetaxel', 'E3805 Chemohormonal Therapy vs Androgen Ablation']","['Measures\n\n\nTwo-year freedom from CRPC and 5-year overall survival', 'Overall survival', 'Hazard ratios', 'docetaxel outcome varied with genotype', 'overall survival']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}]","[{'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]",475.0,0.105053,"Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death.","[{'ForeName': 'Jason W D', 'Initials': 'JWD', 'LastName': 'Hearn', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Almassi', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Reichard', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chandana A', 'Initials': 'CA', 'LastName': 'Reddy', 'Affiliation': 'Department of Radiation Oncology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Cancer Biostatistics Section, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hobbs', 'Affiliation': 'Cancer Biostatistics Section, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Jarrard', 'Affiliation': 'Department of Medical Oncology, University of Wisconsin Hospital and Clinics, Madison.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreicer', 'Affiliation': 'University of Virginia Cancer Center, Charlottesville.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Garcia', 'Affiliation': 'Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'Department of Medical Oncology, University of Kentucky, Lexington.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Sharifi', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}]",JAMA oncology,['10.1001/jamaoncol.2019.6496']
431,31855086,"HL301 versus Umckamin in the treatment of acute bronchitis: a phase III, randomized, controlled, double-blind, multicenter study.","Objective:  HL301 is a combination product of seven medicinal plants that has been proven effective in acute bronchitis by two phase II studies. In the present study, its efficacy and safety compared with those of Umckamin in the treatment of acute bronchitis were evaluated in phase III, randomized, controlled, double-blind, multicenter trial design. Methods:  A total of 246 acute bronchitis patients were randomized to receive either HL301 (600 mg/day) or Umckamin (333 mg/day) for seven days. The primary outcome was the difference in their baseline (visit 2) and end of treatment (visit 3) bronchitis severity score (BSS). Other efficacy variables included the change in each BSS component (cough, sputum, dyspnea, chest pain, and crackle), response rate, improvement rate, and satisfaction rate with treatment. Results:  A full analysis set and per protocol set analysis of both groups revealed that the difference of BSS between visit 2 and visit 3 in the HL301 and Umckamin group was not significantly different (4.58 ± 1.79 versus 4.29 ± 1.88,  p = .37  and 4.60 ± 1.81 versus 4.33 ± 1.88,  p = .42 , respectively). The change in five BSS components (cough, sputum, dyspnea, chest pain, and crackle) of the HL301 and Umckamin groups did not differ after treatment. HL301 or Umckamin treated participants showed an equal level of response, improvement, and satisfaction rates with treatment. Both the HL301 group and Umckamin group showed the same safety profile. Conclusions:  HL301 (600 mg/day) was as effective and safe as Umckamin (333 mg/day) in treating acute bronchitis.",2020,"HL301 or Umckamin treated participants showed an equal level of response, improvement, and satisfaction rates with treatment.","['246 acute bronchitis patients', 'acute bronchitis']","['HL301', 'Umckamin', 'HL301 versus umckamin']","['difference in their baseline (visit 2) and end of treatment (visit 3) bronchitis severity score (BSS', 'BSS component (cough, sputum, dyspnea, chest pain, and crackle), response rate, improvement rate, and satisfaction rate', 'equal level of response, improvement, and satisfaction rates', 'effective and safe as Umckamin', 'efficacy and safety', 'five BSS components (cough, sputum, dyspnea, chest pain, and crackle']","[{'cui': 'C0149514', 'cui_str': 'Acute tracheobronchitis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0034642', 'cui_str': 'Rales'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.397304,"HL301 or Umckamin treated participants showed an equal level of response, improvement, and satisfaction rates with treatment.","[{'ForeName': 'Won-Young', 'Initials': 'WY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Myung Jae', 'Initials': 'MJ', 'LastName': 'Park', 'Affiliation': 'Department of Pulmonology and Critical Care Medicine, Kyung Hee University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Chin Kook', 'Initials': 'CK', 'LastName': 'Rhee', 'Affiliation': ""Department of Internal Medicine, College of Medicine, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sang Yeub', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Korea University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Do Jin', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.'}, {'ForeName': 'Dong Gyu', 'Initials': 'DG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University Kangnam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Chang-Min', 'Initials': 'CM', 'LastName': 'Choi', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Deog Kyeom', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Yee Hyung', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.'}, {'ForeName': 'Ho Joo', 'Initials': 'HJ', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Hanyang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Yeol', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Republic of Korea.'}]",Current medical research and opinion,['10.1080/03007995.2019.1706044']
432,30837573,Hydrogen peroxide-based products alter inflammatory and tissue damage-related proteins in the gingival crevicular fluid of healthy volunteers: a randomized trial.,"Hydrogen peroxide (H 2 O 2 )-based products are effective in tooth whitening; however, their safety is controversial as they may harm patient tissues/cells. These effects are suggested to be concentration-dependent; nonetheless, to date, there are no reports on H 2 O 2 -mediated oxidative damage in the gingival tissue, and neither whether this can be detected in gingival crevicular fluid (GCF) samples. We hypothesize that H 2 O 2  whitening products may cause collateral oxidative tissue damage following in office application. Therefore, H 2 O 2  and nitric oxide (NO) levels were investigated in GCF samples obtained from patients undergoing dental bleaching with H 2 O 2  at different concentrations, in a randomized, double-blind, split-mouth clinical trial. A proteomic analysis of these samples was also performed. H 2 O 2 -based whitening products promoted inflammation which was detected in GCF samples and lasted for longer following 35% H 2 O 2  bleaching. This included time-dependent changes in NO levels and in the abundance of proteins associated with NO synthesis, oxidative stress, neutrophil regulation, nucleic acid damage, cell survival and/or tissue regeneration. Overall, H 2 O 2 -based products used in office promote inflammation irrespective of their concentration. As the inflammation caused by 35% H 2 O 2  is longer ,  patients may benefit better from using lower concentrations of this bleaching product, as they may result in less tissue damage.",2019,H 2 O 2 -based whitening products promoted inflammation which was detected in GCF samples and lasted for longer following 35% H 2 O 2  bleaching.,['healthy volunteers'],"['Hydrogen peroxide', 'Hydrogen peroxide-based products']","['nitric oxide (NO) levels', 'collateral oxidative tissue damage', 'NO synthesis, oxidative stress, neutrophil regulation, nucleic acid damage, cell survival and/or tissue regeneration']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1275670', 'cui_str': 'Collateral'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0028606', 'cui_str': 'Nucleic Acids'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0349676', 'cui_str': 'Regeneration - action (qualifier value)'}]",,0.329993,H 2 O 2 -based whitening products promoted inflammation which was detected in GCF samples and lasted for longer following 35% H 2 O 2  bleaching.,"[{'ForeName': 'Valderlane L P', 'Initials': 'VLP', 'LastName': 'Colares', 'Affiliation': 'Programa de Pós-graduação, Universidade Ceuma, São Luís, MA, Brazil.'}, {'ForeName': 'Suellen N L', 'Initials': 'SNL', 'LastName': 'Lima', 'Affiliation': 'Programa de Pós-graduação, Universidade Ceuma, São Luís, MA, Brazil.'}, {'ForeName': 'Nágila C F', 'Initials': 'NCF', 'LastName': 'Sousa', 'Affiliation': 'Programa de Pós-graduação, Universidade Ceuma, São Luís, MA, Brazil.'}, {'ForeName': 'Mizael C', 'Initials': 'MC', 'LastName': 'Araújo', 'Affiliation': 'Programa de Pós-graduação, Universidade Ceuma, São Luís, MA, Brazil.'}, {'ForeName': 'Domingos M S', 'Initials': 'DMS', 'LastName': 'Pereira', 'Affiliation': 'Programa de Pós-graduação, Universidade Ceuma, São Luís, MA, Brazil.'}, {'ForeName': 'Saulo J F', 'Initials': 'SJF', 'LastName': 'Mendes', 'Affiliation': 'Programa de Pós-graduação, Universidade Ceuma, São Luís, MA, Brazil.'}, {'ForeName': 'Simone A', 'Initials': 'SA', 'LastName': 'Teixeira', 'Affiliation': 'Departamento de Farmacologia, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Cristina de A', 'Initials': 'CA', 'LastName': 'Monteiro', 'Affiliation': 'Programa de Pós-graduação, Universidade Ceuma, São Luís, MA, Brazil.'}, {'ForeName': 'Matheus C', 'Initials': 'MC', 'LastName': 'Bandeca', 'Affiliation': 'Programa de Pós-graduação, Universidade Ceuma, São Luís, MA, Brazil.'}, {'ForeName': 'Walter L', 'Initials': 'WL', 'LastName': 'Siqueira', 'Affiliation': 'School of Dentistry and Department of Biochemistry, Schulich School of Medicine & Dentistry, The University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Eduardo B', 'Initials': 'EB', 'LastName': 'Moffa', 'Affiliation': 'Programa de Pós-graduação, Universidade Ceuma, São Luís, MA, Brazil.'}, {'ForeName': 'Marcelo N', 'Initials': 'MN', 'LastName': 'Muscará', 'Affiliation': 'Departamento de Farmacologia, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Fernandes', 'Affiliation': 'Programa de Pós-graduação, Universidade Ceuma, São Luís, MA, Brazil. elizabeth.soares@ceuma.br.'}]",Scientific reports,['10.1038/s41598-019-40006-w']
433,32169259,Investigation of the effect of sensorimotor exercises on proprioceptive perceptions among children with spastic hemiplegic cerebral palsy.,"STUDY DESIGN


This is a blinded randomized clinical trial.
INTRODUCTION


Sensorimotor exercises may be an effective, noninvasive treatment modality for treating patients with pediatric spastic hemiplegic cerebral palsy (CP).
PURPOSE OF THE STUDY


We aim to evaluate the effect of sensorimotor exercises on the proprioceptive capability among children with spastic hemiplegic CP.
METHODS


This randomized clinical trial was performed on children with spastic hemiplegic CP. Thirty children aged 8 to 12 years old, with spastic hemiplegic CP, were randomly selected and equally divided into experimental and control groups (N = 15 for each). A joint positioning test was used to measure the patients' baseline proprioceptive ability. The exercise program included sensory and motor exercises which lasted for 8 weeks (three 60-min sessions per week). The data were analyzed by using Welch and paired-sample t-test at the significance level of P < .05.
RESULTS


The results indicated that the proprioceptive capability of the upper limb could significantly improve (P = .001, effect size = 0.41, observed power = 0.99) by using simultaneous exercising of the sensorimotor complex. The mean increased from 8.53 ± 1.6 to 10.53 ± 1.19 in the experimental group, whereas it changed from 6.66 ± 3.44 to 6.73 ± 3.15 in the control group.
DISCUSSION


In consistent with other studies, the exercises used in the present study enhanced the proprioceptive capability but not sensory performance of the hands of children with hemiplegic. Synchronous sensory and motor training in children with hemiplegic CP may improve the function and organization of the somatosensory cortex and reduce sensory disturbances. Although parents were subjectively satisfied with the outcome of the exercises, such as independency and life style, however these recordings were not measured in this study.
CONCLUSION


Implementing simultaneous sensorimotor exercises can improve the proprioceptive capability of the hand. Therefore, these exercises can be used in the rehabilitation programs to meet the children's needs with hemiplegic CP.",2020,"The results indicated that the proprioceptive capability of the upper limb could significantly improve (P = .001, effect size = 0.41, observed power = 0.99) by using simultaneous exercising of the sensorimotor complex.","['children with spastic hemiplegic CP', 'children with spastic hemiplegic cerebral palsy', 'patients with pediatric spastic hemiplegic cerebral palsy (CP', 'Thirty children aged 8 to 12 years old, with spastic hemiplegic CP', 'children with hemiplegic CP', ""children's needs with hemiplegic CP""]","['Synchronous sensory and motor training', 'sensorimotor exercises', 'Sensorimotor exercises']","['proprioceptive capability', 'proprioceptive perceptions', 'proprioceptive capability of the upper limb']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",30.0,0.0236708,"The results indicated that the proprioceptive capability of the upper limb could significantly improve (P = .001, effect size = 0.41, observed power = 0.99) by using simultaneous exercising of the sensorimotor complex.","[{'ForeName': 'Akram Ahmadi', 'Initials': 'AA', 'LastName': 'Barati', 'Affiliation': 'Department of Physical Education and Sport Science, University of Tehran Alborz Campus, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rajabi', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Health and Sports Medicine, University of Tehran, Tehran, Iran. Electronic address: rrajabi@ut.ac.ir.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Shahrbanian', 'Affiliation': 'Department of Sports Medicine, University of Tehran, Tehran, Iran; Department of Sport Injuries & Corrective Exercise, Faculty of Physical Education and Sport Sciences, Bu-Ali Sina University, Hamedan, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Sedighi', 'Affiliation': 'Department of Neurology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.12.003']
434,31888702,Treatment of hospital-acquired pneumonia with multi-drug resistant organism by Buzhong Yiqi decoction based on Fuzheng Quxie classical prescription: study protocol for a randomized controlled trial.,"BACKGROUND


Drug resistance in China is becoming a more and more serious issue. Infection by drug-resistant bacteria has become a major disease that seriously threatens the health of Chinese people and affects national medical finance. Therefore, it is of great scientific and clinical significance to actively carry out research on the prevention and treatment of infections by multi-drug resistant organisms (MDRO). Previous studies by the authors suggested that patients with hospital-acquired pneumonia caused by MDRO mostly showed the pathological state of ""insufficient healthy Qi and internal accumulation of pathogenic Qi"" and ""acute deficiency syndrome"" mainly characterized by Qi deficiency. Buzhong Yiqi decoction is a famous classic prescription in traditional Chinese medicine (TCM) for treating internal damage fever. This study intends to provide an evidence-based rationale for Buzhong Yiqi decoction in treating MDRO hospital-acquired pneumonia by conducting a multi-center randomized controlled clinical study.
METHODS/DESIGN


This study is designed to be a multi-center randomized controlled study in which patients are assigned randomly into control (standard therapy) and trial (standard therapy plus Buzhong Yiqi decoction) groups. The patients will be selected from the emergency department and the ICU inpatient department of five study sites and will all be diagnosed with MDRO hospital-acquired pneumonia and meet the inclusion criteria. Forty patients are to be enrolled in each study site, resulting in a total of 200 patients in the study. The treatment course is 28 days.
DISCUSSION


In this study: (1) the theory of ""acute Qi deficiency"" in MDRO hospital-acquired pneumonia is put forward for the first time, and the basic theories of TCM are further improved; (2) a multi-center randomized controlled clinical study will be performed for the first time with Buzhong Yiqi decoction, the classic prescription for reinforcing healthy Qi and eliminating pathogenic Qi, providing a reliable evidence-based rationale for the treatment of MDRO pulmonary infection with TCM; (3) the clinical application and modern disease spectrum of Buzhong Yiqi decoction is expanded, and the scientific notion of ""treating different diseases with the same method"" is enriched further.
TRIAL REGISTRATION


China Clinical Trial Registry, ChiCTR1900022429. Registered on April 11, 2019. http://www.chictr.org.cn/listbycreater.aspx.",2019,Infection by drug-resistant bacteria has become a major disease that seriously threatens the health of Chinese people and affects national medical finance.,"['patients with hospital-acquired pneumonia', 'patients will be selected from the emergency department and the ICU inpatient department of five study sites and will all be diagnosed with MDRO hospital-acquired pneumonia and meet the inclusion criteria', 'Forty patients are to be enrolled in each study site, resulting in a total of 200 patients in the study']","['traditional Chinese medicine (TCM', 'Yiqi decoction', 'control (standard therapy) and trial (standard therapy plus Buzhong Yiqi decoction']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],200.0,0.0663201,Infection by drug-resistant bacteria has become a major disease that seriously threatens the health of Chinese people and affects national medical finance.,"[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Deng', 'Affiliation': 'LongHua Hospital Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Zhenyi', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'LongHua Hospital Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Liyang', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'LongHua Hospital Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Bu', 'Affiliation': 'LongHua Hospital Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Miaoqing', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': 'LongHua Hospital Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'LongHua Hospital Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Gen', 'Affiliation': 'LongHua Hospital Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'LongHua Hospital Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'LongHua Hospital Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China.'}, {'ForeName': 'Bangjiang', 'Initials': 'B', 'LastName': 'Fang', 'Affiliation': 'LongHua Hospital Shanghai University of Traditional Chinese Medicine, NO.725 Wanping South Road, Xuhui District, Shanghai, 200032, China. fangbji@163.com.'}]",Trials,['10.1186/s13063-019-3927-x']
435,30995895,Half Saline-Bicarbonate Solution as Intraoperative Fluid Replacement Therapy Leads to Less Acidosis and Better Early Renal Function During Deceased-Donor Transplant.,"OBJECTIVES


Normal saline is the most common crystalloid solution that is used in renal transplant surgery. In this study, our aim was to determine the effects of a combination of half saline and bicarbonate versus normal saline as a routine solution.
MATERIALS AND METHODS


For this double-blind random-ized clinical trial, we enrolled 100 adult patients undergoing kidney transplant. Patients were divided into 2 groups: those who received normal saline and those who received half saline and bicarbonate infusion as fluid replacement therapy during renal transplant. All patients received about 40 mL/kg of crystalloids during surgery. Serial creatinine con-centrations (primary outcomes) were compared between groups at 1, 2, 3, and 7 days after surgery. Urine output (secondary outcome) was compared between groups at recovery and at 6 and 24 hours after surgery. In addition, base excess, chloride, and sodium levels were measured before and 6 hours after surgery. Each liter of half saline-bircarbonate, which is relatively isoosmotic to human plasma, was composed of 70 mEq bicarbonate, 77 mEq chloride, and 147 mEq sodium.
RESULTS


Patients who received half saline-bicarbonate had significantly lower postoperative creatinine levels at all time points than patients who received normal saline (P = .019). Serum chloride and sodium levels (P = .001) were significantly higher and base excess (P = .007) was significantly lower in the normal saline group at 6 hours after transplant. At all time points, urine output levels were significantly higher in the half saline-bicarbonate group (P = .001).
CONCLUSIONS


The use of half saline-bicarbonate was associated with better early graft function compared with normal saline in the first 7 days after transplant.",2020,Serum chloride and sodium levels (P = .001) were significantly higher and base excess (P = .007) was significantly lower in the normal saline group at 6 hours after transplant.,['100 adult patients undergoing kidney transplant'],"['Half Saline-Bicarbonate Solution', 'normal saline and those who received half saline and bicarbonate infusion', 'combination of half saline and bicarbonate versus normal saline', 'bicarbonate', 'normal saline', 'bicarbonate, 77 mEq chloride, and 147 mEq sodium', 'saline-bicarbonate']","['postoperative creatinine levels', 'early graft function', 'Acidosis and Better Early Renal Function', 'Serum chloride and sodium levels', 'urine output levels', 'chloride, and sodium levels', 'Urine output']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0005367', 'cui_str': 'Hydrogen Carbonates'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439152', 'cui_str': 'milliequivalent'}, {'cui': 'C0008203', 'cui_str': 'Chlorides'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0036787', 'cui_str': 'Serum chloride'}, {'cui': 'C0428291', 'cui_str': 'Finding of sodium level (finding)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0008203', 'cui_str': 'Chlorides'}]",100.0,0.597038,Serum chloride and sodium levels (P = .001) were significantly higher and base excess (P = .007) was significantly lower in the normal saline group at 6 hours after transplant.,"[{'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Pourfakhr', 'Affiliation': 'From the Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohaddese', 'Initials': 'M', 'LastName': 'Shafiei', 'Affiliation': ''}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Etezadi', 'Affiliation': ''}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khajavi', 'Affiliation': ''}, {'ForeName': 'Reza Shariat', 'Initials': 'RS', 'LastName': 'Moharari', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2018.0328']
436,32171765,The Prognostic Value of Persistent Culture Positivity in Fungal Keratitis in the Mycotic Antimicrobial Localized Injection Trial.,"PURPOSE


To evaluate the utility of repeat cultures at days 3 and 7 after starting antifungal medications for predicting outcomes in fungal keratitis.
DESIGN


Prespecified secondary analysis of the randomized clinical Mycotic Antimicrobial Localized Injection trial.
METHODS


Patients presenting to Aravind Eye Hospital, Pondicherry, India, with fungal keratitis and visual acuity worse than 20/70 received topical natamycin and were randomized to either receive intrastromal injection of voriconazole or topical therapy alone. All subjects received corneal cultures at date of presentation, day 3, and day 7. Outcome measures included 3-week and 3-month visual acuity and scar size, corneal perforation, and/or the need for therapeutic penetrating keratoplasty (TPK). Visual acuity and scar size were analyzed with multiple linear regression controlling for baseline measures. Survival analysis was used to analyze the risk of corneal perforation and/or need for TPK.
RESULTS


Of the 70 study subjects with fungal keratitis, 25 of 69 (36%) remained culture positive at day 3, and 20 of 62 (32%) were culture positive at day 7. Culture positivity at day 3 conferred a hazard ratio of 2.8 for requiring TPK (P = .03) but was not a statistically significant predictor of perforation, scar size, or final visual acuity. Culture positivity at day 7 had a hazard ratio of 3.5 for requiring TPK (P = .003). Those with positive cultures at day 7 had on average 3 logMAR lines worse visual acuity at 3 months (95% confidence interval 0.9 to 5.2 logMAR lines, P = .006) and 1.1 mm larger scar size at 3 months after controlling for baseline measures (95% confidence interval 0.1 to 2.2 mm; P = .03).
CONCLUSIONS


While not as predictive as day 7 cultures, culture positivity at day 3 after starting treatment is a significant predictor of the need for TPK in patients with moderate-to-severe filamentous fungal keratitis. This has applications for risk stratification, and may facilitate earlier consideration of TPK in high-risk patients.",2020,"Culture positivity at day 3 conferred a hazard ratio of 2.8 for requiring TPK (p=0.03), but was not a statistically significant predictor of perforation, scar size, or final visual acuity.","['Pondicherry with fungal keratitis and visual acuity worse than 20/70 received', 'Patients presenting to Aravind Eye Hospital', 'patients with moderate to severe filamentous fungal keratitis']","['topical natamycin', 'voriconazole or topical therapy alone']","['Visual acuity and scar size', 'fungal keratitis', 'scar size', '3-week and 3-month visual acuity and scar size, corneal perforation and/or the need for therapeutic penetrating keratoplasty (TPK', 'average 3-LogMAR lines worse visual acuity', 'Culture positivity', 'perforation, scar size, or final visual acuity']","[{'cui': 'C1262117', 'cui_str': 'Mycotic keratitis'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0027444', 'cui_str': 'Natamycin'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1262117', 'cui_str': 'Mycotic keratitis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0339293', 'cui_str': 'Corneal Perforation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010042', 'cui_str': 'Grafting, Corneal'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}]",,0.481944,"Culture positivity at day 3 conferred a hazard ratio of 2.8 for requiring TPK (p=0.03), but was not a statistically significant predictor of perforation, scar size, or final visual acuity.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pickel', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Shivananda', 'Initials': 'S', 'LastName': 'Narayana', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Tiruvengada', 'Initials': 'T', 'LastName': 'Krishnan', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Ramakrishnan', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Puja Prativa', 'Initials': 'PP', 'LastName': 'Samantaray', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Redd', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA; UCSF Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rose-Nussbaumer', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA; The Permanente Medical Group, Redwood City, California, USA. Electronic address: jennifer.rose-nussbaumer@ucsf.edu.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.02.021']
437,31489509,Continuation of low-dose acetylsalicylic acid during perioperative period of laparoscopic inguinal hernia repair is safe: results of a prospective clinical trial.,"PURPOSE


Patients taking acetylsalicylic acid are common in surgical departments; in most cases, acetylsalicylic acid is discontinued 5-7 days before the operation to minimize the intra- and postoperative bleeding, but the perioperative management of patients under antithrombotic and anticoagulative treatments is controversial. This study aims to address whether the low-dose acetylsalicylic acid increases bleeding and occurrence of postoperative complications after laparoscopic inguinal hernia repair when it was only ceased on the operation day.
METHOD


From July 2017 to January 2019, 901 patients including 781 (86.7%) male and 120 (13.3%) female patients underwent laparoscopic inguinal hernia repair using trans-abdominal preperitoneal (TAPP) technique were recruited, among whom 152 (16.9%) had been taking low-dose (100 mg per day) acetylsalicylic acid which was continued during hospitalization except the operation day. The intra-operative bleeding volume, postoperative pain, overall occurrence of complications such as seroma, hematoma, scrotal edema, calf muscle venous thrombosis, and the time of resuming normal activities were compared with patients on whom these medications were not needed.
RESULTS


The age, BMI, hospital stay, ASA classification, morbidity of CHD and hypertension, FIB value, and the time of resuming normal activities of patients taking acetylsalicylic acid were higher (p < 0.05). There was no significant difference on mean operative time, intra-operative bleeding volume, and the occurrence postoperative complications among two groups.
CONCLUSION


For patients with inguinal hernias, laparoscopic TAPP repair is completely safe to be performed on those taking low-dose acetylsalicylic acid when it was only ceased on the operation day, with intravenous salvianolate given after the operation instead.",2019,"There was no significant difference on mean operative time, intra-operative bleeding volume, and the occurrence postoperative complications among two groups.
","['technique were recruited, among whom 152 (16.9%) had been taking low-dose (100\xa0mg per day', 'From July 2017 to January 2019, 901 patients including 781 (86.7%) male and 120 (13.3%) female patients underwent', 'patients with inguinal hernias']","['low-dose acetylsalicylic acid', 'laparoscopic inguinal hernia repair', 'laparoscopic inguinal hernia repair using trans-abdominal preperitoneal (TAPP', 'acetylsalicylic acid', 'laparoscopic TAPP repair']","['age, BMI, hospital stay, ASA classification, morbidity of CHD and hypertension, FIB value, and the time of resuming normal activities of patients taking acetylsalicylic acid', 'bleeding and occurrence of postoperative complications', 'intra-operative bleeding volume, postoperative pain, overall occurrence of complications such as seroma, hematoma, scrotal edema, calf muscle venous thrombosis, and the time of resuming normal activities', 'mean operative time, intra-operative bleeding volume, and the occurrence postoperative complications']","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach (qualifier value)'}, {'cui': 'C0163807', 'cui_str': 'tetra-4-amidinophenoxypropane'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0151609', 'cui_str': 'Edema of scrotum (disorder)'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0042487', 'cui_str': 'Phlebothrombosis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",901.0,0.038575,"There was no significant difference on mean operative time, intra-operative bleeding volume, and the occurrence postoperative complications among two groups.
","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': ""Department of General Surgery, Qilu Hospital, Shandong University, 107#, Wenhua Xi Road, Jinan, 250012, Shandong, People's Republic of China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, 100043, People's Republic of China.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ruze', 'Affiliation': ""Department of General Surgery, Qilu Hospital, Shandong University, 107#, Wenhua Xi Road, Jinan, 250012, Shandong, People's Republic of China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': ""Department of General Surgery, Qilu Hospital, Shandong University, 107#, Wenhua Xi Road, Jinan, 250012, Shandong, People's Republic of China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ""Department of General Surgery, Qilu Hospital, Shandong University, 107#, Wenhua Xi Road, Jinan, 250012, Shandong, People's Republic of China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': ""Department of General Surgery, Qilu Hospital, Shandong University, 107#, Wenhua Xi Road, Jinan, 250012, Shandong, People's Republic of China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, 100043, People's Republic of China.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Department of General Surgery, Qilu Hospital, Shandong University, 107#, Wenhua Xi Road, Jinan, 250012, Shandong, People's Republic of China. guangyongzhang@hotmail.com.""}]",Hernia : the journal of hernias and abdominal wall surgery,['10.1007/s10029-019-02040-5']
438,31756267,Improvement of exercise capacity following neonatal respiratory failure: A randomized controlled trial.,"Exercise capacity deteriorates in school-aged children born with major anatomical foregut anomalies and/or treated with extracorporeal membrane oxygenation. The aim of the present study was to evaluate whether exercise capacity can be improved in the short term and long term in children born with anatomical foregut anomalies and/or treated with extracorporeal membrane oxygenation. Therefore, we evaluated two different interventions in this single-blinded randomized controlled trial. Forty participants were randomly assigned to group A: standardized anaerobic high-intensity interval training plus online lifestyle coaching program, B: online lifestyle coaching program only, or C: standard of care. Inclusion criteria were as follows: score ≤-1 standard deviation (SD) on the Bruce protocol. Exercise capacity was assessed at baseline (T0), after 3 months (T1), and after 12 months (T2). Exercise capacity improved over time: mean (SD) standard deviation score (SDS) endurance time: T0 -1.91 (0.73); T1 -1.35 (0.94); T2 -1.20 (1.03): both P < .001. No significant differences in maximal endurance time were found at T1 (group A-C: estimated mean difference (SDS): 0.06 P = .802; group B-C: -0.17 P = .733) or T2 (group A-C: -0.13 P = .635; group B-C: -0.18 P = .587). Exercise capacity improved significantly over time, irrespective of the study arm. Not only residual morbidities may be responsible for reduced exercise capacity. Parental awareness of reduced exercise capacity rather than specific interventions may have contributed. Monitoring of exercise tolerance and providing counseling on lifestyle factors that improve physical activity should be part of routine care, and aftercare should be offered on an individual basis.",2020,No significant differences in maximal endurance time were found at T1 (group A-C: estimated mean difference (SDS):,"['children born with anatomical foregut anomalies and/or treated with', 'school-aged children born with major anatomical foregut anomalies and/or treated with', 'neonatal respiratory failure', 'Forty participants']","['standardized anaerobic high-intensity interval training plus online lifestyle coaching-program, B: online lifestyle coaching-program only, or C: standard of care', 'Exercise capacity deteriorates', 'extracorporeal membrane oxygenation']","['Exercise capacity', 'exercise capacity', 'Exercise capacity improved over time: mean (SD) SDS endurance time', 'maximal endurance time']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0231051', 'cui_str': 'Primitive foregut structure'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0521648', 'cui_str': 'Neonatal respiratory failure (disorder)'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}]",40.0,0.133127,No significant differences in maximal endurance time were found at T1 (group A-C: estimated mean difference (SDS):,"[{'ForeName': 'Leontien C C', 'Initials': 'LCC', 'LastName': 'Toussaint-Duyster', 'Affiliation': ""Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Monique H M', 'Initials': 'MHM', 'LastName': 'van der Cammen-van Zijp', 'Affiliation': ""Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Takken', 'Affiliation': ""Child Development and Exercise Center, Wilhelmina Children's Hospital University Medical Center, Utrecht, The Netherlands.""}, {'ForeName': 'Wouter J', 'Initials': 'WJ', 'LastName': 'Harmsen', 'Affiliation': ""Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Tibboel', 'Affiliation': ""Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Arno F J', 'Initials': 'AFJ', 'LastName': 'van Heijst', 'Affiliation': ""Department of Pediatrics, Radboud University Medical Center-Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'de Blaauw', 'Affiliation': ""Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Rene M H', 'Initials': 'RMH', 'LastName': 'Wijnen', 'Affiliation': ""Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'van Rosmalen', 'Affiliation': 'Department of Biostatistics, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'IJsselstijn', 'Affiliation': ""Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands.""}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13604']
439,32173802,Parecoxib in laparoscopic surgery for simple vesicular lithiasis.,"AIM


To evaluate the contribution of parecoxib to the protocol of multimodal analgesia for simple vesicular lithiasis by laparoscopy.
METHODS


A prospective, randomized, double-blind study was carried out at Habib Thameur Hospital (Tunis). We included 60 patients, ASA I or II, scheduled for cholecystectomy by laparoscopy. The patients were randomized to 2 groups. The parecoxib group (PG) receiving parecoxib 40 mg 30 minutes before the induction and the control group (CG) receiving physiological saline. Data were collected during hospitalization and a follow-up was done one year after the operation by a questionnaire.
RESULTS


The pain scores at rest and at cough were significantly lower in the PG than in the CG during the first postoperative day (p < 10-3). Ten percent of the patients of the CG and no patient of the GP required Morphine in the recovery room (p = 0,07). The requirement of Tramadol was significantly less frequent in the PG (70 % of the PG, 16,6 % of the CG and p < 10-3). A chronic pain was found in 37,5 % and 8 %, respectively, in the GC and GP (p = 0,013). This pain was intense in 2 GC patients requiring analgesics and a work stoppage.
CONCLUSIONS


The results of our study are in favor of the use of Parecoxib 40 mg 30 minutes before laparoscopic cholecystectomy for its effects on acute pain, opioid sparing and chronic pain.",2019,The pain scores at rest and at cough were significantly lower in the PG than in the CG during the first postoperative day (p < 10-3).,"['Habib Thameur Hospital (Tunis', '60 patients, ASA I or II, scheduled for cholecystectomy by laparoscopy']","['Parecoxib', 'laparoscopic cholecystectomy', 'Tramadol', 'parecoxib', 'Morphine', 'control group (CG) receiving physiological saline']","['acute pain, opioid sparing and chronic pain', 'chronic pain', 'pain scores at rest and at cough']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0445341', 'cui_str': 'Tunis (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}]","[{'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}]",2.0,0.0926246,The pain scores at rest and at cough were significantly lower in the PG than in the CG during the first postoperative day (p < 10-3).,"[{'ForeName': 'Faten', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': ''}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Jaoua', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mrabet', 'Affiliation': ''}, {'ForeName': 'Jihène', 'Initials': 'J', 'LastName': 'Bousselmi', 'Affiliation': ''}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Ben Fadhel', 'Affiliation': ''}]",La Tunisie medicale,[]
440,32173808,Postoperative analgesia after wound infiltration with Dexmedetomidine and Ropivacaine versus Ropivacaine alone for lumbar discectomies: a randomized-controlled trial.,"INTRODUCTION


Current LA may provide solid analgesic effect however, their analgesic advantages might be limited by their short life. Several reviews highlight the potential role of ?2-adrenergic receptors agonists like dexmedetomidine (DEX) for postoperative pain control.
AIM


Compare the analgesic efficacy of the sole LA: ropivacaine (R) with the combination of both: ropivacaine and DEX (RD) for wound infiltration (WI) in lumbar discectomies.
METHODS


Prospective, randomized, double-blind, controlled study in nature. Adult patients undergoing elective lumbar discectomies were randomly allocated into two groups: group (R) received 2mg/kg with ropivacaine: 4.75 mg/ml in WI, group RD received the same dose of ropivacaine as the first group adding 0.5 ug/kg of DEX. Visual analog scale (VAS) at 0, 2, 6, 12, 18, and 24 hours (h); time to first rescue analgesia, total post-operative opiate dose was assessed during the first 24 h postoperatively.
RESULTS


VAS values at all time intervals were significantly lower (p< 10-3) in the RD group as compared with the R group. The median time to first rescue analgesia was significantly shorter in the R group 8h [7-12] than RD group 21 h [18-24]. The median (interquartile range) opioid use was 3 [3-6] morphine mg equivalents in the R group and 0 [0-2] morphine mg equivalents in the RD group. The first time to mobilization was significantly shorter in RD group (22±03 h) than R group (27±06 h).",2019,The median time to first rescue analgesia was significantly shorter in the R group 8h,"['Adult patients undergoing elective lumbar discectomies', 'lumbar discectomies']","['ropivacaine and DEX (RD', 'ropivacaine as the first group adding 0.5 ug/kg of DEX', 'Ropivacaine', 'Dexmedetomidine and Ropivacaine', 'sole LA: ropivacaine (R', 'dexmedetomidine (DEX', 'morphine', 'ropivacaine']","['analgesic efficacy', '24 hours (h); time to first rescue analgesia, total post-operative opiate dose', 'first time to mobilization', 'VAS values', 'median time to first rescue analgesia', 'Visual analog scale (VAS', 'Postoperative analgesia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",,0.0657952,The median time to first rescue analgesia was significantly shorter in the R group 8h,"[{'ForeName': 'Mayssa', 'Initials': 'M', 'LastName': 'Daiki', 'Affiliation': ''}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Najar', 'Affiliation': ''}, {'ForeName': 'Rida', 'Initials': 'R', 'LastName': 'Chkili', 'Affiliation': ''}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Rafrafi', 'Affiliation': ''}, {'ForeName': 'Abdelkader', 'Initials': 'A', 'LastName': 'Ben Gabsia', 'Affiliation': ''}, {'ForeName': 'Iheb', 'Initials': 'I', 'LastName': 'Labbène', 'Affiliation': ''}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Ferjani', 'Affiliation': ''}]",La Tunisie medicale,[]
441,31991620,Gamified M-Health Attention Bias Modification Intervention for Individuals with Opioid Use Disorder: Protocol for a Pilot Randomised Study.,"Introduction : Globally, there is an epidemic of opioid use disorders. Locally, in Singapore, there is an increase in the number of individuals abusing opioids. The advances in experimental psychology have highlighted the need to modify unconscious, automatic biases. These automatic, unconscious biases result in individuals having preferential attention to substance-related cues in their natural environment, thus leading to a slip or relapse back into their underlying addictive disorders. Prior studies have demonstrated not only the presence of robust attentional biases amongst individuals with opioid use disorder, even when maintained on methadone; and the effectiveness of bias modification amongst these individuals. There remains limited evaluation of attention bias modification amongst a treatment-seeking cohort of Asian individuals. The objective of this pilot is to ensure that the methods of the planned definitive randomized trial could be conducted.  Methods and Analysis : A non-blinded pilot randomized trial will be conducted. A total of 30 participants will be randomized to receive either the conventional application or the newly designed co-designed application. In order to identify these 30 participants, 60 participants will be recruited and screened to determine if they have baseline biases. Participants will be recruited from the inpatient unit at the National Addictions Management Service (NAMS) Singapore. All participants who are enrolled into the trial will complete a baseline assessment task, and a bias modification assessment and modification task daily. They will have to complete a baseline demographic and clinical information questionnaire, as well as a cravings rating scale before and after the intervention daily. Perspectives-that of self-reported experiences-will be sought from the participants following their completion of three intervention tasks. Descriptive statistical analyses will be performed, and chi-square and ANOVA analyses will be performed. Qualitative analyses will be undertaken for the perspectives shared.  Ethics and Dissemination : Ethical approval has been obtained from the National Healthcare Group's Domain Specific Research Board (DSRB) (approval number that of 2019/00934). The findings arising from this study will be disseminated by means of conferences and publications.",2020,"Prior studies have demonstrated not only the presence of robust attentional biases amongst individuals with opioid use disorder, even when maintained on methadone; and the effectiveness of bias modification amongst these individuals.","['30 participants', '30 participants, 60 participants will be recruited and screened to determine if they have baseline biases', 'Individuals with Opioid Use Disorder', 'Participants will be recruited from the inpatient unit at the National Addictions Management Service (NAMS) Singapore']","['Gamified M-Health Attention Bias Modification Intervention', 'methadone', 'conventional application or the newly designed co-designed application']",[],"[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",[],30.0,0.127204,"Prior studies have demonstrated not only the presence of robust attentional biases amongst individuals with opioid use disorder, even when maintained on methadone; and the effectiveness of bias modification amongst these individuals.","[{'ForeName': 'Melvyn W B', 'Initials': 'MWB', 'LastName': 'Zhang', 'Affiliation': 'National Addiction Management Service, Institute of Mental Health, Singapore 539747, Singapore.'}, {'ForeName': 'Sandor', 'Initials': 'S', 'LastName': 'Heng', 'Affiliation': 'National Addiction Management Service, Institute of Mental Health, Singapore 539747, Singapore.'}, {'ForeName': 'Syidda B', 'Initials': 'SB', 'LastName': 'Amron', 'Affiliation': 'National Addiction Management Service, Institute of Mental Health, Singapore 539747, Singapore.'}, {'ForeName': 'Zaakira', 'Initials': 'Z', 'LastName': 'Mahreen', 'Affiliation': 'National Addiction Management Service, Institute of Mental Health, Singapore 539747, Singapore.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'National Addiction Management Service, Institute of Mental Health, Singapore 539747, Singapore.'}, {'ForeName': 'Daniel S S', 'Initials': 'DSS', 'LastName': 'Fung', 'Affiliation': 'Institute of Mental Health, Singapore 539747, Singapore.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Smith', 'Affiliation': 'Family Medicine and Primary Care, Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, Singapore 308232, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17030752']
442,32160301,Follow-up results of myositis patients treated with H. P. Acthar gel.,"OBJECTIVES


Idiopathic inflammatory myopathies (IIM) are a group of autoimmune diseases characterized by proximal muscle weakness. H. P. Acthar gel [repository corticotropin injection (RCI)] is a formulation of adrenocorticotropic hormone and has been approved by Food and Drug Administration for use in IIM; however, literature is limited. In this study, we report longitudinal follow-up of myositis patients treated with RCI.
METHODS


Patients with refractory IIM who were enrolled in the prospective, open-label RCI trial were included in this study. The post-trial follow-up period was 6 months with assessments every 2 months, which included myositis core set measures including extra-muscular global, muscle and patient global disease activities, HAQ, and manual muscle testing.
RESULTS


Two patients were lost to follow-up after finalization of the trial, and the remaining eight patients were enrolled in the follow-up study. One patient remained on RCI after the trial. In the follow-up period, four of eight patients had flare at on average 4.1 months after the RCI trial. Among the patients who flared, three required an increase in prednisone. One patient was restarted on RCI at 5.5 months, but had minimal improvement after 3 months. Four patients who remained stable continued to satisfy criteria for the definition of improvement through the 6-month follow-up. However, none showed any further improvement in the primary or secondary efficacy outcomes after the initial RCI trial.
CONCLUSION


To our knowledge, this is the first study reporting the follow-up results of patients treated with standard dose and duration of Acthar. We believe that our study will provide the basis for the development of future randomized RCI trials in IIM.",2020,"In the follow-up period, four of eight patients had flare at on average 4.1 months after the RCI trial.","['Two patients were lost to follow-up after finalization of the trial, and the remaining eight patients were enrolled in the follow-up study', 'myositis patients treated with RCI', 'Patients with refractory IIM who were enrolled in the prospective, open-label RCI trial were included in this study']","['H. P. Acthar gel [repository corticotropin injection (RCI', 'prednisone']","['extra-muscular global, muscle and patient global disease activities, HAQ, and manual muscle testing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0027121', 'cui_str': 'Inflammatory Myopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0718234', 'cui_str': 'Acthar'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}]",8.0,0.0221927,"In the follow-up period, four of eight patients had flare at on average 4.1 months after the RCI trial.","[{'ForeName': 'Didem', 'Initials': 'D', 'LastName': 'Saygin', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Chester V', 'Initials': 'CV', 'LastName': 'Oddis', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Marder', 'Affiliation': 'Division of Rheumatology, Northwell Health, Formerly North Shore-Long Island Jewish Medical Center, Queens, NY, USA.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Moghadam-Kia', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Preeya', 'Initials': 'P', 'LastName': 'Nandkumar', 'Affiliation': 'Division of Rheumatology, Northwell Health, Formerly North Shore-Long Island Jewish Medical Center, Queens, NY, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Neiman', 'Affiliation': ''}, {'ForeName': 'Sedin', 'Initials': 'S', 'LastName': 'Dzanko', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Koontz', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Aggarwal', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa076']
443,32162278,A stepwise titration protocol for oral appliance therapy in positional obstructive sleep apnea patients: proof of concept.,"PURPOSE


In patients with positional obstructive sleep apnea (POSA), oral appliance therapy (OAT) is among the first-line treatments. The aim of this study was to evaluate the effects of a new standardized stepwise titration protocol for OAT in a group of patients with POSA.
METHODS


This was an observational intervention trial. Patients who were previously randomized to the OAT intervention arm of a comparison study comprised the subjects for this study. These patients, who had mild to moderate POSA, were assessed after 3 and 12 months for treatment efficacy, objective adherence by temperature microsensor, and side effects. The titration of OAT was performed using a standardized stepwise titration protocol including advancement levels of 60%, 75%, and 90% of the maximum mandibular protrusion. The optimal advancement level per individual was based on a weighted compromise between efficacy and side effects.
RESULTS


In total, 36 patients were included and all completed the titration protocol after 3 months. At baseline, the OAT was set at 60% of the maximal mandibular protrusion position. At a 3-month evaluation, the advancement remained at 60% in 16 patients (44%) and reached 75% advancement in 20 patients (56%). Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months. The 12-month analysis showed consistent results and good OAT tolerance. Six patients (16.7%) terminated OAT and one patient (2.8%) was lost to follow-up.
CONCLUSIONS


This standardized stepwise titration protocol for OAT showed good efficacy, good OAT tolerance, and good objective adherence in patients with mild to moderate POSA. Therefore, the protocol is recommended in research projects to improve standardization of methods between studies and in clinical practice for its practical feasibility.",2020,"Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months.","['positional obstructive sleep apnea patients', '36 patients were included and all completed the titration protocol after 3 months', 'patients with POSA.\nMETHODS', 'patients with positional obstructive sleep apnea (POSA', 'patients with mild to moderate POSA']","['oral appliance therapy (OAT', 'OAT intervention']","['median objective adherence', 'Mean apnea-hypopnea index', 'good OAT tolerance']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",36.0,0.0493953,"Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months.","[{'ForeName': 'M H T', 'Initials': 'MHT', 'LastName': 'de Ruiter', 'Affiliation': 'Department of Oral and Maxillofacial Surgery of the Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. m.h.deruiter@amsterdamumc.nl.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Aarab', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'de Vries', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lobbezoo', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Lange', 'Affiliation': 'Department of Oral and Maxillofacial Surgery of the Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02045-w']
444,31946185,Error Augmentation Improves Visuomotor Adaptation during a Full-Body Balance Task.,"Visual amplification of kinematic errors has successfully been applied to improve performance for upper limb movements. In this study, we investigated whether visual error augmentation can promote faster adaptation during a full-body balance task. Healthy volunteers controlled a cursor by shifting their weight on the THERA-Trainer coro platform. Two experimental groups and one control group were asked to reach visual targets. For the two experimental groups, the cursor's deviation from the ideal straight line trajectory was augmented by a gain of 1.5 and 2, respectively, while the control group did not experience visual error amplification (gain of 1). Error augmentation with a gain of 1.5 enhanced the speed and the amount of motor adaptation, while the highest gain might have decreased the stability of adaptation. As visual feedback is commonly used in balance training, our preliminary data suggest that integrating visual error augmentation in postural exercises may facilitate balance control.",2019,"Error augmentation with a gain of 1.5 enhanced the speed and the amount of motor adaptation, while the highest gain might have decreased the stability of adaptation.",['Healthy volunteers controlled a cursor by shifting their weight on the THERA-Trainer coro platform'],['visual error augmentation'],['Visuomotor Adaptation'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]","[{'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}]",,0.0259138,"Error augmentation with a gain of 1.5 enhanced the speed and the amount of motor adaptation, while the highest gain might have decreased the stability of adaptation.","[{'ForeName': 'Jemina', 'Initials': 'J', 'LastName': 'Fasola', 'Affiliation': ''}, {'ForeName': 'Oliver A', 'Initials': 'OA', 'LastName': 'Kannape', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bouri', 'Affiliation': ''}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Bleuler', 'Affiliation': ''}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Blanke', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2019.8857523']
445,32162420,"Is there enough naloxone to deter the diversion? Effect of concurrent administration of intravenous naloxone on opioid agonist effects of intravenous buprenorphine: A randomised, double-blind, within-subject, crossover study among opioid-dependent subjects.","INTRODUCTION AND AIMS


We aimed to evaluate and compare the effect of different intravenous doses of naloxone on reinforcing effect of intravenous buprenorphine (2 mg) in patients stabilised on sublingual buprenorphine.
DESIGN AND METHODS


This is a double-blind, within-subject, randomised, crossover study. Opioid-dependent patients, with history of intravenous drug use, stabilised on buprenorphine maintenance treatment were included after informed consent (n = 14). We administered and assessed the reinforcing effects of six test conditions: buprenorphine and naloxone co-formulation (BNX) in 4:1, 2:1 and 1:1 dose ratio (i.e. buprenorphine 2 mg + naloxone 0.5, 1 and 2 mg, respectively), buprenorphine alone (2 mg), pheniramine maleate (45.5 mg) and saline at 24 hourly intervals.
RESULTS


No significant opioid withdrawals were precipitated during any test conditions. Compared to buprenorphine alone, 4:1 BNX had comparable euphoria, drug recognition, subjective opiate sensations and drug liking (P > 0.05); 2:1 BNX condition had significantly different subjective euphoria (P = 0.001), opioid recognition (P = 0.002), subjective opioid sensations at 60 min (P = 0.027) and drug liking (P < 0.001), while 1:1 BNX had significantly different objective euphoria (P = 0.002), opioid recognition (P = 0.030), subjective opioid sensations (P < 0.001) and drug liking (P < 0.001). No significant difference was noted on sedation scores between buprenorphine alone and all three combinations of BNX.
DISCUSSION AND CONCLUSIONS


The 4:1 BNX condition did not impact the reinforcing agonist effects of buprenorphine. None of the intravenous BNX combination ratios precipitated opioid withdrawals. Findings emphasise the need for exploring more abuse deterrent mechanisms.",2020,"No significant difference was noted on sedation scores between buprenorphine alone and all three combinations of BNX.
","['Opioid-dependent patients, with history of intravenous drug use, stabilised on buprenorphine maintenance treatment were included after informed consent (n =\u200914', 'patients stabilised on sublingual buprenorphine', 'opioid-dependent subjects']","['buprenorphine alone (2 mg), pheniramine maleate', 'buprenorphine', 'naloxone', 'buprenorphine and naloxone co-formulation (BNX', 'buprenorphine 2 mg\u2009+\u2009naloxone']","['sedation scores', 'opioid recognition', 'euphoria, drug recognition, subjective opiate sensations and drug liking', 'subjective opioid sensations', 'subjective euphoria', 'drug liking', 'objective euphoria']","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0887016', 'cui_str': 'Pheniramine Maleate'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C1171048', 'cui_str': 'Buprenorphine 2 MG'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.157362,"No significant difference was noted on sedation scores between buprenorphine alone and all three combinations of BNX.
","[{'ForeName': 'Naveen K', 'Initials': 'NK', 'LastName': 'Dhagudu', 'Affiliation': 'Department of Psychiatry, Viswabharathi Medical College, Kurnool, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Ambekar', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashwani K', 'Initials': 'AK', 'LastName': 'Mishra', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Raka', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and National Drug Dependence Treatment Center, National Drug Dependence Treatment Center, All India Institute of Medical Sciences, New Delhi, India.'}]",Drug and alcohol review,['10.1111/dar.13057']
446,31356896,Sensorimotor Connectivity after Motor Exercise with Neurofeedback in Post-Stroke Patients with Hemiplegia.,"Impaired finger motor function in post-stroke hemiplegia is a debilitating condition with no evidence-based or accessible treatments. Here, we evaluated the neurophysiological effectiveness of direct brain control of robotic exoskeleton that provides movement support contingent with brain activity. To elucidate the mechanisms underlying the neurofeedback intervention, we assessed resting-state functional connectivity with functional magnetic resonance imaging (rsfcMRI) between the ipsilesional sensory and motor cortices before and after a single 1-h intervention. Eighteen stroke patients were randomly assigned to crossover interventions in a double-blind and sham-controlled design. One patient dropped out midway through the study, and 17 patients were included in this analysis. Interventions involved motor imagery, robotic assistance, and neuromuscular electrical stimulation administered to a paretic finger. The neurofeedback intervention delivered stimulations contingent on desynchronized ipsilesional electroencephalographic (EEG) oscillations during imagined movement, and the control intervention delivered sensorimotor stimulations that were independent of EEG oscillations. There was a significant time × intervention interaction in rsfcMRI in the ipsilesional sensorimotor cortex. Post-hoc analysis showed a larger gain in increased functional connectivity during the neurofeedback intervention. Although the neurofeedback intervention delivered fewer total sensorimotor stimulations compared to the sham-control, rsfcMRI in the ipsilesional sensorimotor cortices was increased during the neurofeedback intervention compared to the sham-control. Higher coactivation of the sensory and motor cortices during neurofeedback intervention enhanced rsfcMRI in the ipsilesional sensorimotor cortices. This study showed neurophysiological evidence that EEG-contingent neurofeedback is a promising strategy to induce intrinsic ipsilesional sensorimotor reorganization, supporting the importance of integrating closed-loop sensorimotor processing at a neurophysiological level.",2019,Higher coactivation of the sensory and motor cortices during neurofeedback intervention enhanced rsfcMRI in the ipsilesional sensorimotor cortices.,"['Eighteen stroke patients', 'One patient dropped out midway through the study, and 17 patients were included in this analysis', 'Post-Stroke Patients with Hemiplegia']","['Motor Exercise with Neurofeedback', 'functional magnetic resonance imaging (rsfcMRI', 'motor imagery, robotic assistance, and neuromuscular electrical stimulation administered to a paretic finger']","['ipsilesional sensorimotor cortices', 'desynchronized ipsilesional electroencephalographic (EEG) oscillations', 'functional connectivity', 'total sensorimotor stimulations']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}]","[{'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",,0.0560577,Higher coactivation of the sensory and motor cortices during neurofeedback intervention enhanced rsfcMRI in the ipsilesional sensorimotor cortices.,"[{'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Tsuchimoto', 'Affiliation': 'School of Fundamental Science and Technology, Graduate School of Keio University, Kanagawa, 223-8522, Japan; Japan Society for the Promotion of Science, Tokyo, 102-0083, Japan.'}, {'ForeName': 'Keiichiro', 'Initials': 'K', 'LastName': 'Shindo', 'Affiliation': 'Department of Rehabilitation Medicine, Keio University School of Medicine, Tokyo, 160-8582, Japan; Shonan Keiiku Hospital, Kanagawa, 252-0816, Japan.'}, {'ForeName': 'Fujiko', 'Initials': 'F', 'LastName': 'Hotta', 'Affiliation': 'Department of Rehabilitation Medicine, Keio University School of Medicine, Tokyo, 160-8582, Japan; Tokyo Metropolitan Rehabilitation Hospital, Tokyo, 131-0034, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hanakawa', 'Affiliation': 'Integrative Brain Imaging Center, National Center of Neurology and Psychiatry, Tokyo, 187-8551, Japan; Japan Science and Technology Agency, Precursory Research for Embryonic Science and Technology, 332-0012, Saitama, Japan.'}, {'ForeName': 'Meigen', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Keio University School of Medicine, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Ushiba', 'Affiliation': 'Department of Biosciences and Informatics, Faculty of Science and Technology, Keio University, Kanagawa, 223-8522, Japan; Keio Institute of Pure and Applied Sciences, Faculty of Science and Technology Graduate School of Science and Technology, Keio University, Kanagawa, 223-8522, Japan. Electronic address: ushiba@bio.keio.ac.jp.'}]",Neuroscience,['10.1016/j.neuroscience.2019.07.037']
447,32156477,Feasibility and impact of the implementation of a clinical scale-based sedation-analgesia protocol in severe burn patients undergoing mechanical ventilation. A before-after bi-center study.,"BACKGROUND


Severe burn patients undergo prolonged administration of sedatives and analgesics for burn care. There are currently no guidelines for the dose adaptation of sedation-analgesia in severe burn patients.
METHODS


We performed a before-after 2-center study to demonstrate the feasibility and efficacy of a sedation-analgesia scale-based protocol in severely burned patients receiving ≥24h of invasive mechanical ventilation. Before the intervention, continuous infusion of hypnotic and morphine derivatives was continued. During the Intervention phase, general anesthesia was relayed from day 1 by RASS/BPS-titrated continuous infusion of hypnotic and morphine derivatives and with short half-life drugs adminstered for daily burn dressings. The primary outcome was the duration of invasive mechanical ventilation in the ICU.
RESULTS


Eighty-seven (46.2%) patients were included in the Control phase and 101 (53.7%) in the Intervention phase. The median burned cutaneous surface was 20% [11%-38%] and median ABSI was 7 [5-9]. The durations of hypnotic and opioid infusions were not statistically different between the 2 phases (8 days [2-24] vs. 6 days [2-17] (P=0.3) and 17 days [4-32] vs. 8 days [3-23] (P=0.06), respectively). The duration of mechanical ventilation was 14 days [3-29] in the Control phase and 7 days [2-24] in the Intervention phase (P=0.7). When taking into account the competition between mortality and weaning from mechanical ventilation, we found no significant difference between the 2 phases (Gray test, P=0.4). The time-series analysis showed no difference for the duration of mechanical ventilation in the Intervention phase (P=0.6). Eighteen (20.7%) patients died in the Control phase, and 18 (18%) in the Intervention phase (P=0.6).
CONCLUSION


Scale-based lightening of continuous sedation-analgesia with repeated short general anesthesia for dressing is feasible in severe burn patients but failed to demonstrate a decrease in the duration of invasive mechanical ventilation.",2020,The time-series analysis showed no difference for the duration of mechanical ventilation in the Intervention phase (P=0.6).,"['Eighty-seven (46.2', 'severe burn patients undergoing mechanical ventilation', 'severe burn patients', 'Severe burn patients undergo prolonged administration of sedatives and analgesics for burn care', 'severely burned patients receiving ≥24h of invasive mechanical ventilation']","['clinical scale-based sedation-analgesia protocol', 'sedation-analgesia scale-based protocol']","['duration of mechanical ventilation', 'durations of hypnotic and opioid infusions', 'duration of invasive mechanical ventilation', 'feasibility and efficacy', 'median burned cutaneous surface', 'median ABSI', 'duration of invasive mechanical ventilation in the ICU']","[{'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0344106', 'cui_str': 'Sedative therapy'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1276417', 'cui_str': 'Burn care'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0020591', 'cui_str': 'Hypnotics'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]",,0.0569331,The time-series analysis showed no difference for the duration of mechanical ventilation in the Intervention phase (P=0.6).,"[{'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Cinotti', 'Affiliation': 'Department of Anesthesia and Critical Care, Hôpital Guillaume et René Laennec, University Hospital of Nantes, Boulevard Jacques Monod, Saint-Herblain 44800, France. Electronic address: raphael.cinotti@chu-nantes.fr.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Besnard', 'Affiliation': 'Medical Intensive Care Unit, Hôpital Lapeyronie, Montpellier University and MontpellierTeaching Hospital, 191, Avenue du Doyen Gaston Giraud, MontpellierCedex 5, Montpellier, 34295, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Desmedt', 'Affiliation': 'Anesthesia and Critical Care, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France.'}, {'ForeName': 'Ronan Le', 'Initials': 'RL', 'LastName': 'Floch', 'Affiliation': 'Anesthesia and Critical Care, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Perrot', 'Affiliation': 'Department of Plastic and Burn Surgery, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Bekara', 'Affiliation': 'Department of Plastic and Burn Surgery, Montpellier University and Montpellier Teaching Hospital, Hôpital Lapeyronie 191, Avenue du Doyen Gaston Giraud, Montpellier Cedex 5, Montpellier 34295, France.'}, {'ForeName': 'Kada', 'Initials': 'K', 'LastName': 'Klouche', 'Affiliation': 'Medical Intensive Care Unit, Hôpital Lapeyronie, Montpellier University and MontpellierTeaching Hospital, 191, Avenue du Doyen Gaston Giraud, MontpellierCedex 5, Montpellier, 34295, France; INSERM U1046, CNRS UMR9214, Hôpital Lapeyronie 191, Avenue du Doyen Gaston Giraud, MontpellierCedex 5, Université deMontpellier, Montpellier 34295, France.'}, {'ForeName': 'Romaric', 'Initials': 'R', 'LastName': 'Larcher', 'Affiliation': 'Medical Intensive Care Unit, Hôpital Lapeyronie, Montpellier University and MontpellierTeaching Hospital, 191, Avenue du Doyen Gaston Giraud, MontpellierCedex 5, Montpellier, 34295, France.'}, {'ForeName': 'Pierre-Joachim', 'Initials': 'PJ', 'LastName': 'Mahé', 'Affiliation': 'Anesthesia and Critical Care, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Frasca', 'Affiliation': 'Department of Anesthesia and Critical Care, Centre Hospitalo-Universitaire, University Hospital of Poitiers, 2 rue de la Milétrie Poitiers 86021, France; INSERM SPHERE U1246 «MethodS for Patients-centered outcomes and HEalth REsearch», UFR des sciences pharmaceutiques, University of Nantes, University of Tours, 22 boulevard Benoni-Goullin, Nantes 44200, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': 'Anesthesia and Critical Care, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France; Laboratoire UPRES EA 3826 «Thérapeutiques cliniques et expérimentales des infections». University hospital of Nantes, 22 boulevard Benoni-Goullin, Nantes 44200, France.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Jung', 'Affiliation': 'Medical Intensive Care Unit, Hôpital Lapeyronie, Montpellier University and MontpellierTeaching Hospital, 191, Avenue du Doyen Gaston Giraud, MontpellierCedex 5, Montpellier, 34295, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roquilly', 'Affiliation': 'Anesthesia and Critical Care, University Hospital of Nantes, Hôtel Dieu, 1 place Alexis Ricordeau, Nantes 44093, France; Laboratoire UPRES EA 3826 «Thérapeutiques cliniques et expérimentales des infections». University hospital of Nantes, 22 boulevard Benoni-Goullin, Nantes 44200, France.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.02.009']
448,32157631,Cost-Effectiveness of Subsequent Whole-Brain Radiotherapy or Hippocampal-Avoidant Whole-Brain Radiotherapy Versus Stereotactic Radiosurgery or Surgery Alone for Treatment of Melanoma Brain Metastases.,"BACKGROUND


A randomized phase III trial comparing whole-brain radiotherapy (WBRT) to observation following definitive local treatment of intracranial melanoma metastases with neurosurgery and/or stereotactic surgery (SRS) is underway.
OBJECTIVE


We sought to assess the pre-trial cost-effectiveness of WBRT, hippocampal-avoidant WBRT (HA-WBRT), and observation (SRS or surgery alone) for this population to guide trial data collection efforts and reduce decision uncertainty.  METHODS: A time-dependent Markov model followed patients treated with neurosurgery or SRS who received subsequent WBRT, HA-WBRT or observation over a 5-year time horizon. Model inputs were sourced from published literature and results tested for robustness using probabilistic sensitivity analysis. Value of information (VOI) analysis was undertaken to guide data collection for the randomized trial.
RESULTS


Over 5 years, the WBRT strategy produced 1.74 QALYs (2.38 life-years) at a mean cost of $40,128 (costs in 2017 Australian dollars); HA-WBRT produced 1.88 QALYs (2.38 life-years) and cost $42,977; and SRS/surgery alone produced 1.65 QALYs (2.13 life-years) at a cost of $46,281. Probabilistic sensitivity analysis showed HA-WBRT was the preferred strategy in 77% of simulations. Cost-effectiveness results were most sensitive to utilities of the controlled-disease health state in the WBRT group, and costs of HA-WBRT. The EVPI for a randomized trial was estimated at $6,888 per person.
CONCLUSIONS


HA-WBRT may be cost-effective for the treatment of melanoma brain metastases. The results predicted in our model can be validated with prospective trial data when available.",2020,"Cost-effectiveness results were most sensitive to utilities of the controlled-disease health state in the WBRT group, and costs of HA-WBRT.","['intracranial melanoma metastases with', 'Melanoma Brain Metastases']","['neurosurgery and/or stereotactic surgery (SRS', 'WBRT, hippocampal-avoidant WBRT (HA-WBRT), and observation (SRS or surgery alone', 'Subsequent Whole-Brain Radiotherapy or Hippocampal-Avoidant Whole-Brain Radiotherapy Versus Stereotactic Radiosurgery or Surgery', 'whole-brain radiotherapy (WBRT']","['Cost-Effectiveness', 'costs of HA-WBRT']","[{'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}]","[{'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1735594', 'cui_str': 'Stereotactic surgery'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C3846112', 'cui_str': 'Radiosurgery, Stereotactic'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.098716,"Cost-effectiveness results were most sensitive to utilities of the controlled-disease health state in the WBRT group, and costs of HA-WBRT.","[{'ForeName': 'Anh Dam', 'Initials': 'AD', 'LastName': 'Tran', 'Affiliation': 'Health Economics, National Drug and Alcohol Research Centre, University of New South Wales, 22-32 King street, Sydney, NSW, 2031, Australia. anh.tran@unsw.edu.au.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Fogarty', 'Affiliation': ""St Vincent's Department of Radiotherapy, St Vincent's Hospital, Darlinghurst, NSW, 2010, Australia.""}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': 'Medical School, University of Western Australia, Crawley, WA, 6009, Australia.'}, {'ForeName': 'Vakaramoko', 'Initials': 'V', 'LastName': 'Diaby', 'Affiliation': 'Health Economics and Outcomes Research, Department of Pharmaceutical Outcomes and Policy (POP), College of Pharmacy, University of Florida, 1225 Center Drive, Gainesville, FL, 32610, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hong', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, North Sydney, NSW, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Watts', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, North Sydney, NSW, Australia.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Morton', 'Affiliation': 'Health Economics, National Drug and Alcohol Research Centre, University of New South Wales, 22-32 King street, Sydney, NSW, 2031, Australia.'}]",Applied health economics and health policy,['10.1007/s40258-020-00560-1']
449,31493549,Transcranial Direct Current Stimulation over the Left Dorsolateral Prefrontal Cortex Improves Inhibitory Control and Endurance Performance in Healthy Individuals.,"The dorsolateral prefrontal cortex (DLPFC) is a crucial brain region for inhibitory control, an executive function essential for behavioral self-regulation. Recently, inhibitory control has been shown to be important for endurance performance. Improvement in inhibitory control was found following transcranial direct current stimulation (tDCS) applied over the left DLPFC (L-DLPFC). This study examined the effect tDCS on both an inhibitory control and endurance performance in a group of healthy individuals. Twelve participants received either real tDCS (Real-tDCS) or placebo tDCS (Sham-tDCS) in randomized order. The anodal electrode was placed over the L-DLPFC while the cathodal electrode was placed above Fp2. Stimulation lasted 30min with current intensity set at 2mA. A Stroop test was administered to assess inhibitory control. Heart rate (HR), ratings of perceived exertion (RPE), and leg muscle pain (PAIN) were monitored during the cycling time to exhaustion (TTE) test, while blood lactate accumulation (∆B[La - ]) was measured at exhaustion. Stroop task performance was improved after Real-tDCS as demonstrated by a lower number of errors for incongruent stimuli (p=0.012). TTE was significantly longer following Real-tDCS compared to Sham-tDCS (p=0.029, 17±8 vs 15±8min), with significantly lower HR (p=0.002) and RPE (p<0.001), while no significant difference was found for PAIN (p>0.224). ∆B[La - ] was significantly higher at exhaustion in Real-tDCS (p=0.040). Our findings provide preliminary evidence that tDCS with the anodal electrode over the L-DLPFC can improve both inhibitory control and endurance cycling performance in healthy individuals.",2019,Stroop task performance was improved after Real-tDCS as demonstrated by a lower number of errors for incongruent stimuli (p = 0.012).,"['healthy individuals', 'Healthy Individuals', 'a group of healthy individuals']","['transcranial direct current stimulation (tDCS', 'Transcranial Direct Current Stimulation', 'real tDCS (Real-tDCS) or placebo tDCS (Sham-tDCS']","['Heart rate (HR), ratings of perceived exertion (RPE), and leg muscle pain (PAIN', 'Stroop task performance', 'RPE', 'PAIN', 'TTE test, while blood lactate accumulation (∆B[La - ', 'TTE']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}]",12.0,0.0500649,Stroop task performance was improved after Real-tDCS as demonstrated by a lower number of errors for incongruent stimuli (p = 0.012).,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Angius', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham Maritime, United Kingdom; Faculty of Health and Life Sciences, Sport, Exercise and Rehabilitation, Northumbria University, Newcastle-upon-Tyne, United Kingdom. Electronic address: luca.angius@northumbria.ac.uk.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Santarnecchi', 'Affiliation': 'Berenson-Allen Center for Non-Invasive Brain Stimulation, Division of Cognitive Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pascual-Leone', 'Affiliation': 'Berenson-Allen Center for Non-Invasive Brain Stimulation, Division of Cognitive Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Institut Universitari de Neurorehabilitacio Guttmann, Badalona, Barcelona, Spain.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Marcora', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham Maritime, United Kingdom; Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, Bologna, Italy.'}]",Neuroscience,['10.1016/j.neuroscience.2019.08.052']
450,31558454,Measuring open defecation in India using survey questions: evidence from a randomised survey experiment.,"OBJECTIVES


To investigate differences in reported open defecation between a question about latrine use or open defecation for every household member and a household-level question.
SETTING


Rural India is home to most of the world's open defecation. India's Demographic and Health Survey (DHS) 2015-2016 estimates that 54% of households in rural India defecate in the open. This measure is based on a question asking about the behaviour of all household members in one question. Yet, studies in rural India find substantial open defecation among individuals living in households with latrines, suggesting that household-level questions underestimate true open defecation.
PARTICIPANTS


In 2018, we randomly assigned latrine-owning households in rural parts of four Indian states to receive one of two survey modules measuring sanitation behaviour. 1215 households were asked about latrine use or open defecation individually for every household member. 1216 households were asked the household-level question used in India's DHS: what type of facility do members of the household usually use?
RESULTS


We compare reported open defecation between households asked the individual-level questions and those asked the household-level question. Using two methods for comparing open defecation by question type, the individual-level question found 20-21 (95% CI 16 to 25 for both estimates) percentage points more open defecation than the household-level question, among all households, and 28-29 (95% CI 22 to 35 for both estimates) percentage points more open defecation among households that received assistance to construct their latrines.
CONCLUSIONS


We provide the first evidence that individual-level questions find more open defecation than household-level questions. Because reducing open defecation in India is essential to meeting the Sustainable Development Goals, and exposure to open defecation has consequences for child mortality and development, it is essential to accurately monitor its progress.
TRIAL REGISTRATION NUMBER


Registry for International Development Impact Evaluations (5b55458ca54d1).",2019,"Using two methods for comparing open defecation by question type, the individual-level question found 20-21 (95% CI 16 to 25 for both estimates) percentage points more open defecation than the household-level question, among all households, and 28-29 (95% CI 22 to 35 for both estimates) percentage points more open defecation among households that received assistance to construct their latrines.
","['1216 households', '1215 households']","['latrine-owning households in rural parts of four Indian states to receive one of two survey modules measuring sanitation behaviour', 'latrine use or open defecation individually for every household member']",[],"[{'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0023124', 'cui_str': 'Latrines'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",[],2016.0,0.0486213,"Using two methods for comparing open defecation by question type, the individual-level question found 20-21 (95% CI 16 to 25 for both estimates) percentage points more open defecation than the household-level question, among all households, and 28-29 (95% CI 22 to 35 for both estimates) percentage points more open defecation among households that received assistance to construct their latrines.
","[{'ForeName': 'Sangita', 'Initials': 'S', 'LastName': 'Vyas', 'Affiliation': 'Economics and Population Research Center, University of Texas at Austin, Austin, Texas, USA sangita.vyas@utexas.edu.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Srivastav', 'Affiliation': 'r.i.c.e, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Mary', 'Affiliation': 'IFMR LEAD, Institute for Financial Management and Research, Chennai, India.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'International Initiative for Impact Evaluation, New Delhi, India.'}, {'ForeName': 'Sujatha', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'IFMR LEAD, Institute for Financial Management and Research, Chennai, India.'}, {'ForeName': 'Ajaykumar', 'Initials': 'A', 'LastName': 'Tannirkulam', 'Affiliation': 'IFMR LEAD, Institute for Financial Management and Research, Chennai, India.'}, {'ForeName': 'Radu', 'Initials': 'R', 'LastName': 'Ban', 'Affiliation': 'Evidence and Measurement, WSH Program, Bill and Melinda Gates Foundation, Seattle, Washington, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Spears', 'Affiliation': 'Economics and Population Research Center, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Coffey', 'Affiliation': 'r.i.c.e, India.'}]",BMJ open,['10.1136/bmjopen-2019-030152']
451,31888700,A counseling intervention to address HIV stigma at entry into antenatal care in Tanzania (Maisha): study protocol for a pilot randomized controlled trial.,"BACKGROUND


HIV-related stigma significantly impacts HIV care engagement, including in prevention of mother-to-child transmission of HIV (PMTCT) programs. Maisha is a stigma-based counseling intervention delivered during the first antenatal care (ANC) visit, complementing routine HIV counseling and testing. The goal of Maisha is to promote readiness to initiate and sustain treatment among those who are HIV-positive, and to reduce HIV stigmatizing attitudes among those who test negative.
METHODS


A pilot randomized control trial will assess the feasibility and acceptability of delivering Maisha in a clinical setting, and the potential efficacy of the intervention on HIV care engagement outcomes (for HIV-positive participants) and HIV stigma constructs (for all participants). A total of 1000 women and approximately 700 male partners will be recruited from two study clinics in the Moshi municipality of Tanzania. Participants will be enrolled at their first ANC visit, prior to HIV testing. It is estimated that 50 women (5%) will be identified as HIV-positive. Following consent and a baseline survey, participants will be randomly assigned to either the control (standard of care) or the Maisha intervention. The Maisha intervention includes a video and counseling session prior to HIV testing, and two additional counseling sessions if the participant tests positive for HIV or has an established HIV diagnosis. A subset of approximately 500 enrolled participants (all HIV-positive participants, and a random selection of HIV-negative participants who have elevated stigma attitude scores) will complete a follow-up assessment at 3 months. Measures will include health outcomes (care engagement, antiretroviral adherence, depression) and HIV stigma outcomes. Quality assurance data will be collected and the feasibility and acceptability of the intervention will be described. Statistical analysis will examine potential differences between conditions in health outcomes and stigma measures, stratified by HIV status.
DISCUSSION


ANC provides a unique and important entry point to address HIV stigma. Interventions are needed to improve retention in PMTCT care and to improve community attitudes toward people living with HIV. Results of the Maisha pilot trial will be used to generate parameter estimates and potential ranges of values to estimate power for a full cluster-randomized trial in PMTCT settings, with extended follow-up and enhanced adherence measurement using a biomarker.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03600142. Registered on 25 July 2018.",2019,"BACKGROUND


HIV-related stigma significantly impacts HIV care engagement, including in prevention of mother-to-child transmission of HIV (PMTCT) programs.","['1000 women and approximately 700 male partners will be recruited from two study clinics in the Moshi municipality of Tanzania', 'HIV-positive participants) and HIV stigma constructs (for all participants', 'A subset of approximately 500 enrolled participants (all HIV-positive participants, and a random selection of HIV-negative participants who have elevated stigma attitude scores) will complete a follow-up assessment at 3\u2009months', 'Participants will be enrolled at their first ANC visit, prior to HIV testing', 'people living with HIV']","['counseling intervention', 'control (standard of care) or the Maisha intervention']","['health outcomes (care engagement, antiretroviral adherence, depression) and HIV stigma outcomes']","[{'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0600182'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",1000.0,0.13369,"BACKGROUND


HIV-related stigma significantly impacts HIV care engagement, including in prevention of mother-to-child transmission of HIV (PMTCT) programs.","[{'ForeName': 'Melissa H', 'Initials': 'MH', 'LastName': 'Watt', 'Affiliation': 'Department of Population Health Sciences, University of Utah, 295 Chipeta Way, Williams Building, Room 1N410, Salt Lake City, UT, 84108, USA. melissa.watt@utah.edu.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Knippler', 'Affiliation': 'Duke Global Health Institute, Duke University, Box 90519, Durham, NC, 27701, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Minja', 'Affiliation': 'Kilimanjaro Clinical Research Institute, Moshi, Tanzania.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Kisigo', 'Affiliation': 'Duke Global Health Institute, Duke University, Box 90519, Durham, NC, 27701, USA.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Knettel', 'Affiliation': 'Duke Global Health Institute, Duke University, Box 90519, Durham, NC, 27701, USA.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Ngocho', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Renju', 'Affiliation': 'Department of Population Health, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Haika', 'Initials': 'H', 'LastName': 'Osaki', 'Affiliation': 'Kilimanjaro Clinical Research Institute, Moshi, Tanzania.'}, {'ForeName': 'Rimel', 'Initials': 'R', 'LastName': 'Mwamba', 'Affiliation': 'Duke Global Health Institute, Duke University, Box 90519, Durham, NC, 27701, USA.'}, {'ForeName': 'Jane J', 'Initials': 'JJ', 'LastName': 'Rogathi', 'Affiliation': 'Kilimanjaro Christian Medical Centre, School of Nursing, Moshi, Tanzania.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Clinical Research Institute, Moshi, Tanzania.'}]",Trials,['10.1186/s13063-019-3933-z']
452,31505955,Influence of Infant Cleft Dimensions on Velopharyngeal Function in 5-Year-Old Danish Children Born With Unilateral Cleft Lip and Palate.,"AIM


To examine the association of cleft severity at infancy and velopharyngeal competence in preschool children with unilateral cleft lip and palate operated with early or delayed hard palate repair.
DESIGN


Subgroup analysis within a multicenter randomized controlled trial of primary surgery (Scandcleft).
SETTING


Tertiary health care. One surgical center.
PATIENTS AND METHODS


One hundred twenty-five infants received cheilo-rhinoplasty and soft palate repair at age 3 to 4 months and were randomized to hard palate closure at age 12 or 36 months. Cleft size and cleft morphology were measured 3 dimensionally on digital models, obtained by laser surface scanning of preoperative plaster models (mean age: 1.8 months).
MAIN OUTCOME MEASUREMENTS


Velopharyngeal competence (VPC) and hypernasality assessed from a naming test (VPC-Sum) and connected speech (VPC-Rate). In both scales, higher scores indicated a more severe velopharyngeal insufficiency.
RESULTS


No difference between surgical groups was shown. A low positive correlation was found between posterior cleft width and VPC-Rate (Spearman = .23;  P  = .025). The role of the covariate ""cleft size at tuberosity level"" was confirmed in an ordinal logistic regression model (odds ratio [OR] = 1.17; 95% confidence interval [CI]:1.01-1.35). A low negative correlation was shown between anteroposterior palatal length and VPC-Sum (Spearman = -.27;  P  = .004) and confirmed by the pooled scores VPC-Pooled (OR = 0.82; 95% CI: 0.69-0.98) and VPC-Dichotomic (OR = 0.82; 95% CI: 0.68-0.99).
CONCLUSIONS


Posterior cleft dimensions can be a modest indicator for the prognosis of velopharyngeal function at age 5 years, when the soft palate is closed first, independently on the timing of hard palate repair. Antero-posterior palatal length seems to protect from velopharyngeal insufficiency and hypernasality. However, the association found was significant but low.",2020,"A low negative correlation was shown between anteroposterior palatal length and VPC-Sum (Spearman = -.27;  P  = .004) and confirmed by the pooled scores VPC-Pooled (OR = 0.82; 95% CI: 0.69-0.98) and VPC-Dichotomic (OR = 0.82; 95% CI: 0.68-0.99).
","['5-Year-Old Danish Children Born With Unilateral Cleft Lip and Palate', 'preschool children with unilateral cleft lip and palate operated with early or delayed hard palate repair', 'One hundred twenty-five infants received', 'Tertiary health care']","['Infant Cleft Dimensions', 'primary surgery (Scandcleft', 'cheilo-rhinoplasty and soft palate repair at age 3 to 4 months and were randomized to hard palate closure']","['Velopharyngeal Function', 'posterior cleft width and VPC-Rate', 'severe velopharyngeal insufficiency', 'Cleft size and cleft morphology', 'Velopharyngeal competence (VPC) and hypernasality assessed from a naming test (VPC-Sum) and connected speech (VPC-Rate', 'anteroposterior palatal length and VPC-Sum']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0392006'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0226901', 'cui_str': 'Hard Palate'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C1536072', 'cui_str': 'Soft palate repair'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0226901', 'cui_str': 'Hard Palate'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042454', 'cui_str': 'Velopharyngeal Incompetence'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0264614', 'cui_str': 'Hypernasality syndrome (disorder)'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",125.0,0.140521,"A low negative correlation was shown between anteroposterior palatal length and VPC-Sum (Spearman = -.27;  P  = .004) and confirmed by the pooled scores VPC-Pooled (OR = 0.82; 95% CI: 0.69-0.98) and VPC-Dichotomic (OR = 0.82; 95% CI: 0.68-0.99).
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Botticelli', 'Affiliation': 'Section of Orthodontics, Aarhus University, Denmark.'}, {'ForeName': 'Annelise', 'Initials': 'A', 'LastName': 'Küseler', 'Affiliation': 'Section of Orthodontics, Aarhus University, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Mølsted', 'Affiliation': 'Copenhagen Cleft Palate Center, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Helene Soegaard', 'Initials': 'HS', 'LastName': 'Andersen', 'Affiliation': 'Copenhagen Cleft Palate Center, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Boers', 'Affiliation': 'Copenhagen Cleft Palate Center, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Shoeps', 'Affiliation': 'Copenhagen Cleft Palate Center, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Berit Kildegaard', 'Initials': 'BK', 'LastName': 'Emborg', 'Affiliation': 'Cleft Lip and Palate Center, IKH, Region Midt, Aarhus, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Kisling-Møller', 'Affiliation': 'Cleft Lip and Palate Center, IKH, Region Midt, Aarhus, Denmark.'}, {'ForeName': 'Thomas Klit', 'Initials': 'TK', 'LastName': 'Pedersen', 'Affiliation': 'Section of Orthodontics, Aarhus University, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Department of Plastic Surgery and Burns Treatment, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Willadsen', 'Affiliation': 'Department of Nordic Studies and Linguistics, University of Copenhagen, Denmark.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665619874143']
453,31038996,Emulating a Novel Clinical Trial Using Existing Observational Data. Predicting Results of the PreVent Study.,"Rationale:  ""Target trial emulation"" has been proposed as an observational method to answer comparative effectiveness questions, but it has rarely been attempted concurrently with a randomized clinical trial (RCT). Objectives:  We tested the hypothesis that blinded analysts applying target trial emulation to existing observational data could predict the results of an RCT. Methods:  PreVent (Preventing Hypoxemia with Manual Ventilation during Endotracheal Intubation) was a multicenter RCT examining the effects of positive-pressure ventilation during tracheal intubation on oxygen saturation and severe hypoxemia. Analysts unaware of PreVent's results used patient-level data from three previous trials evaluating airway management interventions to emulate PreVent's eligibility criteria, randomization procedure, and statistical analysis. After PreVent's release, results of this blinded observational analysis were compared with those of the RCT. Difference-in-differences estimates for comparison of treatment effects between the observational analysis and the PreVent trial are reported on the absolute scale. Results:  Using observational data, we were able to emulate PreVent's randomization procedure to produce balanced groups for comparison. The lowest oxygen saturation during intubation was higher in the positive-pressure ventilation group than the no positive-pressure ventilation group in the observational analysis ( n  = 360; mean difference = 1.8%; 95% confidence interval [CI] = -1.0 to 4.6) and in the PreVent trial ( n  = 401; mean difference = 3.9%; 95% CI = 1.4 to 6.4), though the observational analysis could not exclude no difference. Difference-in-differences estimates comparing treatment effects showed reasonable agreement for lowest oxygen saturation between the observational analysis and the PreVent trial (mean difference = -2.1%; 95% CI = -5.9 to 1.7). Positive-pressure ventilation resulted in lower rates of severe hypoxemia in both the observational analysis (risk ratio = 0.60; 95% CI = 0.38 to 0.93) and in the PreVent trial (risk ratio = 0.48; 95% CI = 0.30 to 0.77). The absolute reduction in the incidence of severe hypoxemia with positive-pressure ventilation was similar in the observational analysis (9.4%) and the PreVent trial (12.0%), though the difference between these estimates had wide CIs (mean difference = 2.5%; 95% CI = -8.0 to 13.6%). Conclusions:  Applying target trial emulation methods to existing observational data for the evaluation of a novel intervention produced results similar to those of a randomized trial. These findings support the use of target trial emulation for comparative effectiveness research.",2019,"Positive pressure ventilation resulted in lower rates of severe hypoxemia in both the observational analysis (RR 0.60, 95% CI 0.38-0.93) and in the PreVent trial (RR 0.48, 95% CI 0.30-0.77).",[],['positive pressure ventilation'],"['severe hypoxemia', 'severe hypoxemia with positive pressure ventilation', 'oxygen saturation and severe hypoxemia', 'lowest oxygen saturation', 'Positive pressure ventilation', 'lowest oxygen saturation during intubation']",[],"[{'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range (finding)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",401.0,0.5047,"Positive pressure ventilation resulted in lower rates of severe hypoxemia in both the observational analysis (RR 0.60, 95% CI 0.38-0.93) and in the PreVent trial (RR 0.48, 95% CI 0.30-0.77).","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Admon', 'Affiliation': '1Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Donnelly', 'Affiliation': '2Institute for Healthcare Policy and Innovation.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': '5Division of Pulmonary, Allergy, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Janz', 'Affiliation': '6Section of Pulmonary/Critical Care & Allergy/Immunology, Louisiana State University School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Russell', 'Affiliation': '7Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Joffe', 'Affiliation': '8Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Vonderhaar', 'Affiliation': '9Department of Pulmonary and Critical Care Medicine, Ochsner Health System New Orleans, New Orleans, Louisiana.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Dischert', 'Affiliation': '9Department of Pulmonary and Critical Care Medicine, Ochsner Health System New Orleans, New Orleans, Louisiana.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Stempek', 'Affiliation': '11Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Dargin', 'Affiliation': '11Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': '5Division of Pulmonary, Allergy, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Iwashyna', 'Affiliation': '1Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': '5Division of Pulmonary, Allergy, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201903-241OC']
454,31463735,Comparing the Effectiveness of a Guide Booklet to Simulation-Based Training for Management of Acute Agitation.,"Simulation-based training may be an effective teaching modality for psychiatry residents; however, simulation-based training is an unstudied and underutilized aspect of psychiatry resident training. The objective of this study was to compare the teaching effectiveness of a simulation-based training to reading a resident on-call psychiatry guide booklet in improving the self-confidence and knowledge of residents that is necessary for managing acutely agitated patients. Pre-intervention self-confidence and knowledge were measured for all residents using a Likert scale questionnaire and a clinical vignette questionnaire, respectively. Residents (n = 23) were randomly assigned to either the simulation group (n = 12) or the guide booklet group (n = 11). Residents in the simulation group completed the simulation-based training, and residents in the guide booklet group were instructed to read the corresponding pages of the booklet regarding management of acute agitation. The comparative teaching effectiveness of the guide booklet and simulation-based training was measured with a post-intervention self-confidence questionnaire and a clinical vignette questionnaire. The study spanned approximately one academic year (July 2016- Sept 2017). Residents who participated in the simulation-based training showed significantly greater improvement in self-confidence (simulation median improvement = 1.458 vs. guide median improvement = 0.033, p = 0.002) and knowledge (simulation median improvement = 0.135 vs. guide median improvement = 0.021, p = 0.0124). Simulation-based training was more effective at improving residents' self-confidence and knowledge compared to the on-call psychiatry booklet for the management of acutely agitated patients. Though simulation is being used in other specialties, it is a very underutilized tool in the field of psychiatry. This finding underscores the potential for simulation-based training in residency programs to improve resident learning.",2019,Simulation-based training was more effective at improving residents' self-confidence and knowledge compared to the on-call psychiatry booklet for the management of acutely agitated patients.,"['Residents (n\xa0', 'acutely agitated patients', 'psychiatry residents']","['guide booklet and simulation-based training', 'guide booklet group', 'simulation-based training, and residents in the guide booklet group were instructed to read the corresponding pages of the booklet regarding management of acute agitation', 'simulation-based training to reading a resident on-call psychiatry guide booklet', 'Simulation-based training', 'Guide Booklet to Simulation-Based Training']",['self-confidence'],"[{'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",,0.0238117,Simulation-based training was more effective at improving residents' self-confidence and knowledge compared to the on-call psychiatry booklet for the management of acutely agitated patients.,"[{'ForeName': 'J Corey', 'Initials': 'JC', 'LastName': 'Williams', 'Affiliation': ""The Children's Hospital of Philadelphia, Department of Child & Adolescent Psychiatry and Behavioral Sciences, Philadelphia, PA, USA. williamj28@email.chop.edu.""}, {'ForeName': 'Lilanthi', 'Initials': 'L', 'LastName': 'Balasuriya', 'Affiliation': 'Department of Psychiatry, Yale-New Haven Hospital, New Haven, CT, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Alexander-Bloch', 'Affiliation': 'Department of Psychiatry, Yale-New Haven Hospital, New Haven, CT, USA.'}, {'ForeName': 'Zheala', 'Initials': 'Z', 'LastName': 'Qayyum', 'Affiliation': 'School of Medicine, Harvard University, Boston, MA, USA.'}]",The Psychiatric quarterly,['10.1007/s11126-019-09670-z']
455,31338790,Does Change over Time in Delusional Beliefs as Measured with PDI Predict Change over Time in Belief Flexibility Measured with MADS?,"Delusional beliefs and their behavioral consequences are predominant symptoms in patients with psychosis and play an important role in the treatment. Delusional beliefs are a multidimensional concept which can be divided into three components: distress, preoccupation and conviction of delusions. These can be measured using Peters delusions inventory (PDI-21). We question, whether changes in delusional beliefs over time during treatment measured with the PDI-21 can predict changes in belief flexibility measured with the Maudsley assessment of delusions schedule (MADS). We used a group of patients from a randomized controlled trial for a cognitive intervention for psychosis or psychotic symptoms. Aside standard treatment for psychosis, half of the patients took part in a group treatment ""Michael's game"". Patients were assessed at baseline (T1), at 3 months (T2), and at 9 months (T3). We measured delusional beliefs using PDI-21 and belief flexibility with the MADS. One hundred seventy-two patients were included in the analysis. We measured a main effect of PDI-21scores on belief flexibility measured with MADS. PDI-21 Conviction scores predicted outcomes for all measured MADS items. Increasing PDI Distress and Preoccupation scores were predictors for being more likely to dismiss beliefs and change conviction. Time itself was a predictor for changing conviction and being able to plan a behavioral experiment. Overall the changes in PDI scores predicted outcomes for belief flexibility measured with MADS items. The PDI-21 could be a simple and effective way to measure progress in treatment on delusional beliefs.",2019,Increasing PDI Distress and Preoccupation scores were predictors for being more likely to dismiss beliefs and change conviction.,"['One hundred seventy-two patients were included in the analysis', 'patients with psychosis', 'for psychosis or psychotic symptoms']",['cognitive intervention'],"['Delusional beliefs', 'Increasing PDI Distress and Preoccupation scores']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}]",[],"[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation with ideas'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",172.0,0.0396772,Increasing PDI Distress and Preoccupation scores were predictors for being more likely to dismiss beliefs and change conviction.,"[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Penzenstadler', 'Affiliation': 'Geneva University Hospitals, Ch, du Petit Bel-Air 2, 1225, Chêne-Bourg, Switzerland. Louise.E.Penzenstadler@hcuge.ch.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chatton', 'Affiliation': 'Geneva University Hospitals, Ch, du Petit Bel-Air 2, 1225, Chêne-Bourg, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Huguelet', 'Affiliation': 'Geneva University Hospitals, Ch, du Petit Bel-Air 2, 1225, Chêne-Bourg, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Lecardeur', 'Affiliation': 'UNICAEN, Imagerie et Strategies Therapeutiques de la schizophrenie (ISTS), Normandie University, EA4766, 14000, Caen, France.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bartolomei', 'Affiliation': 'Geneva University Hospitals, Ch, du Petit Bel-Air 2, 1225, Chêne-Bourg, Switzerland.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Brazo', 'Affiliation': 'UNICAEN, Imagerie et Strategies Therapeutiques de la schizophrenie (ISTS), Normandie University, EA4766, 14000, Caen, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Murys', 'Affiliation': 'Unité Mobile de Psychiatrie, Centre Hospitalier Princesse Grace, Monaco, Monaco.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Poupart', 'Affiliation': 'Laboratoire Clinique Psychopathologique et Interculturelle, Université de Toulouse, Toulouse, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Rouvière', 'Affiliation': 'CRESOP, Centre Hospitalier le Vinatier, Bron, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Saoud', 'Affiliation': 'PsyR2, INSERM U1028, CNRS UMR5292, PSYR2 Team, Lyon Neuroscience Research Center, Lyon, France Department of Consultation-Liaison Psychiatry, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Favrod', 'Affiliation': 'La Source, School of Nursing Sciences, HES-SO University of Applied Sciences and Arts of Western Switzerland, Lausanne, Switzerland.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Khazaal', 'Affiliation': 'Addiction Medicine, Department of Psychiatry, Lausanne University Hospitals, Lausanne, Switzerland.'}]",The Psychiatric quarterly,['10.1007/s11126-019-09659-8']
456,32150484,"Effects of  Aster glehni  Extract on Serum Uric Acid in Subjects with Mild Hyperuricemia: A Randomized, Placebo-Controlled Trial.","Aster glehni  extracts (AGE) reduced serum uric acid levels in hyperuricemia rats in several previous studies. However, its efficacy in human has not been yet explored. This study aimed at investigating the efficacy and safety of AGE on the anti-hyperuricemia effect in subjects with slightly high serum uric acid. A randomized, double-blinded, placebo-controlled clinical trial was conducted for 12 weeks. Eligible subjects were randomly assigned to either AGE (480 mg/day) or placebo. The primary endpoint was the change in serum uric acid concentrations from baseline to follow-up time points. The secondary endpoints were the change of serum xanthine oxidase activity, and the levels of C-reactive protein (CRP) and tumor necrosis factor alpha (TNF- α ) in the blood from baseline to follow-up time points. Safety was assessed by clinical laboratory parameters and adverse events reported by subjects. Six weeks of AGE supplementation significantly reduced serum uric acid level from baseline ( P  = .0468) but at the end of the intervention the participants did not show the beneficial effect of AGE supplementation. Also, the serum uric acid level in the AGE group was not significantly different at the follow-up time points, when compared with placebo. The mean changes of secondary endpoints from baseline to each time point did not show significant differences within and between the two groups. There were no adverse events reported by subjects or changes in safety parameters after intervention. In conclusion, AGE supplementation for 12 weeks did not show significant benefits for reducing serum uric acid concentrations in subjects with mild hyperuricemia.",2020,The mean changes of secondary endpoints from baseline to each time point did not show significant differences within and between the two groups.,"['subjects with slightly high serum uric acid', 'hyperuricemia rats', 'subjects with mild hyperuricemia', 'Eligible subjects', 'Subjects with Mild Hyperuricemia']","['Aster glehni  Extract', 'placebo', 'AGE', 'Aster glehni  extracts (AGE', 'Placebo']","['serum uric acid level', 'serum uric acid concentrations', 'Serum Uric Acid', 'change of serum xanthine oxidase activity, and the levels of C-reactive protein (CRP) and tumor necrosis factor alpha (TNF- α ', 'Safety', 'serum uric acid levels', 'change in serum uric acid concentrations']","[{'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]","[{'cui': 'C0331312', 'cui_str': 'Aster Plant'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0043317', 'cui_str': 'Hypoxanthine Dehydrogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.299161,The mean changes of secondary endpoints from baseline to each time point did not show significant differences within and between the two groups.,"[{'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Life Sciences, College of Life Sciences and Biotechnology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Hye', 'Initials': 'EH', 'LastName': 'Han', 'Affiliation': 'R&D Center, Koreaeundan Healthcare Co., Ansan-si, Republic of Korea.'}, {'ForeName': 'Sang Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'R&D Center, Koreaeundan Healthcare Co., Ansan-si, Republic of Korea.'}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Lim', 'Affiliation': 'R&D Center, Koreaeundan Co., Seongnam-si, Republic of Korea.'}, {'ForeName': 'Chang-O', 'Initials': 'CO', 'LastName': 'Kim', 'Affiliation': 'Clinical Research Center, Yangji Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seongman', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Division of Life Sciences, College of Life Sciences and Biotechnology, Korea University, Seoul, Republic of Korea.'}]",Journal of medicinal food,['10.1089/jmf.2019.4513']
457,31594555,The AMBER care bundle for hospital inpatients with uncertain recovery nearing the end of life: the ImproveCare feasibility cluster RCT.,"BACKGROUND


Patients admitted to hospital with a terminal illness and uncertain recovery often receive inconsistent care and do not have the opportunity to die in their preferred place of death. Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented. The AMBER (Assessment; Management; Best practice; Engagement; Recovery uncertain) care bundle was developed to remedy this. It has not been evaluated in a randomised trial, but a definitive trial would face many hurdles.
OBJECTIVE


To optimise the design of and determine the feasibility of a pragmatic, multicentre, cluster randomised controlled trial of the AMBER care bundle compared with best standard care.
DESIGN


A feasibility cluster randomised controlled trial including semistructured interviews with patients and relatives, focus groups with health-care professionals, non-participant observations of multidisciplinary team meetings, a standard care survey, heat maps and case note reviews. Retrospective data were collected from the family or close friends of deceased patients via a bereavement survey.
SETTING


Four general medical wards at district general hospitals in England.
PARTICIPANTS


There were 65 participants (control,  n  = 36; intervention,  n  = 29). There were 24 interviews, four focus groups, 15 non-participant meeting observations, six case note reviews and three heat maps, and 15 of out 23 bereavement, standard care surveys were completed.
INTERVENTION


The AMBER care bundle is implemented by a nurse facilitator. It includes the development and documentation of a medical plan, consideration of outcomes, resuscitation and escalation status and daily plan revisiting. The AMBER care bundle encourages staff, patients and families to talk openly about their preferences and priorities should the worst happen.
MAIN OUTCOME MEASURES


Two 'candidate' primary outcomes were selected to be evaluated for a future definitive trial: Integrated Palliative care Outcome Scale patient/family anxiety and communication subscale and ' howRwe '. The secondary outcome measures were Integrated Palliative care Outcome Scale symptoms, Australian-modified Karnofsky Performance Status scale, EuroQol-5 Dimensions, five-level version, Client Service Receipt Inventory, recruitment rate, intervention fidelity and intervention acceptability.
RESULTS


Data were collected for 65 patients. This trial was not powered to measure clinical effectiveness, but variance and changes observed in the Integrated Palliative care Outcome Scale subscale indicated that this measure would probably detect differences within a definitive trial. It was feasible to collect data on health, social and informal care service use and on quality of life at two time points. The AMBER care bundle was broadly acceptable to all stakeholders and was delivered as planned. The emphasis on 'clinical uncertainty' prompted health-care professional awareness of often-overlooked patients. Reviewing patients' AMBER care bundle status was integrated into routine practice. Refinements included simplifying the inclusion criteria and improving health-care professional communication training. Improvements to trial procedures included extending the time devoted to recruitment and simplifying consent procedures. There was also a recommendation to reduce data collected from patients and relatives to minimise burden.
LIMITATIONS


The recruitment rate was lower than anticipated. The inclusion criteria for the trial were difficult to interpret. Information sheets and consent procedures were too detailed and lengthy for the target population. Health-care professionals' enthusiasm and specialty were not considered while picking trial wards. Participant recruitment took place later during hospital admission and the majority of participants were lost to follow-up because they had been discharged. Those who participated may have different characteristics from those who did not.
CONCLUSIONS


This feasibility trial has demonstrated that an evaluation of the AMBER care bundle among an acutely unwell patient population, although technically possible, is not practical or feasible. The intervention requires optimisation.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN36040085. National Institute for Health Research (NIHR) Portfolio registration number 32682.
FUNDING


This project was funded by the NIHR Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 55. See the NIHR Journals Library website for further project information.",2019,"Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented.","['Four general medical wards at district general hospitals in England', '65 participants (control,  n \u2009=\u200936; intervention,  n \u2009=\u200929', 'acutely unwell patient population', 'National Institute for Health Research (NIHR', 'hospital inpatients with uncertain recovery nearing the end of life', '24 interviews, four focus groups, 15 non-participant meeting observations, six case note reviews and three heat maps, and 15 of out 23 bereavement, standard care surveys were completed', '65 patients', 'semistructured interviews with patients and relatives, focus groups with health-care professionals, non-participant observations of multidisciplinary team meetings, a standard care survey, heat maps and case note reviews', 'Patients admitted to hospital with a terminal illness']",[],"['Integrated Palliative care Outcome Scale symptoms, Australian-modified Karnofsky Performance Status scale, EuroQol-5 Dimensions, five-level version, Client Service Receipt Inventory, recruitment rate, intervention fidelity and intervention acceptability', 'recruitment rate', ""Palliative care Outcome Scale patient/family anxiety and communication subscale and ' howRwe ""]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0857256', 'cui_str': 'Unwell'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035168'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient (finding)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1879338', 'cui_str': 'Bereavement due to life event (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0558037', 'cui_str': 'Non-participant observation (regime/therapy)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0679247', 'cui_str': 'Terminal illness (finding)'}]",[],"[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",23.0,0.0682041,"Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Koffman', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yorganci', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Fliss', 'Initials': 'F', 'LastName': 'Murtagh', 'Affiliation': 'Wolfson Palliative Care Research Centre, University of Hull, Hull, UK.'}, {'ForeName': 'Deokhee', 'Initials': 'D', 'LastName': 'Yi', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barclay', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pickles', 'Affiliation': ""Clinical Trials Unit, King's College London, London, UK.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Higginson', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Halle', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'Patient and public representative.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Ewart', 'Affiliation': 'Patient and public representative.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': ""Cicely Saunders Institute, King's College London, London, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23550']
458,32056146,"Self-Monitoring and Management of Blood Pressure in Patients with Stroke or TIA: An Economic Evaluation of TEST-BP, A Randomised Controlled Trial.","BACKGROUND


Prevention of secondary stroke following initial ictus is an important focus of after-stroke care. Blood pressure (BP) is a key risk factor, so usual care following stroke or transient ischaemic attack includes regular BP checks and monitoring of anti-hypertensive medication. This is traditionally carried out in primary care, but the evidence supporting self-monitoring and self-guided management of BP in the general population with hypertension is growing.
OBJECTIVE


Our objective was to estimate the cost effectiveness of treatment as usual (TAU) versus (1) self-monitoring of BP (S-MON) and (2) self-monitoring and guided self-management of anti-hypertensive medication (S-MAN).
METHODS


This was a within-trial economic evaluation of a randomised controlled trial estimating the incremental cost per 1 mmHg BP reduction and per quality-adjusted life-year (QALY) gained over a 6-month time horizon from the perspective of the UK National Health Service (NHS).
RESULTS


Data were evaluable for 140 participants. Costs per patient were £473, £853 and £1035; mean reduction in systolic BP (SBP) was 3.6, 6.7 and 6.1 mmHg, and QALYs accrued were 0.427, 0.422 and 0.423 for TAU, S-MON and S-MAN, respectively. No statistically significant differences in incremental costs or outcomes were detected. On average, S-MAN was dominated or extended dominated. The incremental cost per 1 mmHg BP reduction from S-MON versus TAU was £137.
CONCLUSION


On average, S-MAN is an inefficient intervention. S-MON may be cost effective, depending on the willingness to pay for a 1 mmHg BP reduction, although it yielded fewer QALYs over the within-trial time horizon. Decision modelling is required to explore the longer-term costs and outcomes.",2020,"Costs per patient were £473, £853 and £1035; mean reduction in systolic BP (SBP) was 3.6, 6.7 and 6.1 mmHg, and QALYs accrued were 0.427, 0.422 and 0.423 for TAU, S-MON and S-MAN, respectively.","['Data were evaluable for 140 participants', 'Patients with Stroke or TIA']","['Self-Monitoring and Management of Blood Pressure', 'usual (TAU) versus (1) self-monitoring of BP (S-MON) and (2) self-monitoring and guided self-management of anti-hypertensive medication (S-MAN']","['incremental cost per 1\xa0mmHg BP reduction and per quality-adjusted life-year (QALY', 'Blood pressure (BP', 'systolic BP (SBP', 'incremental costs or outcomes']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",,0.107845,"Costs per patient were £473, £853 and £1035; mean reduction in systolic BP (SBP) was 3.6, 6.7 and 6.1 mmHg, and QALYs accrued were 0.427, 0.422 and 0.423 for TAU, S-MON and S-MAN, respectively.","[{'ForeName': 'Lois G', 'Initials': 'LG', 'LastName': 'Kim', 'Affiliation': 'Cambridge Centre for Health Services Research, Institute of Public Health, University of Cambridge School of Clinical Medicine, Forvie Site, Cambridge, UK.'}, {'ForeName': 'Edward C F', 'Initials': 'ECF', 'LastName': 'Wilson', 'Affiliation': 'Cambridge Centre for Health Services Research, Institute of Public Health, University of Cambridge School of Clinical Medicine, Forvie Site, Cambridge, UK. ed.wilson@uea.ac.uk.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Davison', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Clark', 'Affiliation': 'Medical Statistics Group, Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Phyo K', 'Initials': 'PK', 'LastName': 'Myint', 'Affiliation': 'Ageing Clinical and Experimental Research (ACER), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Potter', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.'}]",PharmacoEconomics - open,['10.1007/s41669-020-00196-w']
459,32118723,Effects of less invasive surfactant administration (LISA) via a gastric tube on the treatment of respiratory distress syndrome in premature infants aged 32 to 36 weeks.,"To explore the clinical effects of less invasive surfactant administration (LISA) via a gastric tube on the treatment of respiratory distress syndrome (RDS) in premature infants aged 32 to 36 weeks.A total of 97 premature infants with RDS admitted to the Children's Hospital of Shanxi from February 2017 to January 2018 were randomly divided into LISA (47 cases) and (intubation-surfactant-extubation,) INSURE groups (50 cases). In the LISA group, 6F gastric tubes were inserted into the trachea through direct laryngoscopy under nasal continuous positive airway pressure (NCPAP), and pulmonary surfactant (PS) was injected. In the INSURE group, PS was injected via tracheal intubation and NCPAP was performed after extubation. The incidence of technical-related adverse events and various complications in the two groups were observed.PS was successfully injected through gastric tube in the LISA group. There were no significant differences in reflux, asphyxia, bradycardia (<100 beats/min), apnea, FiO2, changes in PaO2 and PaCO2 at 1 hour post-treatment between the groups. During the course of administration, blood pressure and SpO2 in the LISA group were more stable, and significant differences between the 2 groups were observed. However, no significant differences in the complications and outcomes between the 2 groups occurred.The LISA technique can be used to treat premature infants with RDS aged 32 to 36 weeks with stronger spontaneous breathing ability. Further clinical studies are required to determine the optimal strategy of LISA administration and the most profitable patient population.",2020,"There were no significant differences in reflux, asphyxia, bradycardia (<100 beats/min), apnea, FiO2, changes in PaO2 and PaCO2 at 1 hour post-treatment between the groups.","[""97 premature infants with RDS admitted to the Children's Hospital of Shanxi from February 2017 to January 2018"", 'premature infants with RDS aged 32 to 36 weeks with stronger spontaneous breathing ability', 'premature infants aged 32 to 36 weeks']","['LISA', 'direct laryngoscopy under nasal continuous positive airway pressure (NCPAP), and pulmonary surfactant (PS', 'invasive surfactant administration (LISA) via a gastric tube', 'invasive surfactant administration (LISA']","['respiratory distress syndrome', 'respiratory distress syndrome (RDS', 'incidence of technical-related adverse events and various complications', 'blood pressure and SpO2', 'reflux, asphyxia, bradycardia (<100\u200abeats/min), apnea, FiO2, changes in PaO2 and PaCO2']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0518227', 'cui_str': 'Ease of respiration (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}, {'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0034085', 'cui_str': 'Pulmonary Surfactants'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}]","[{'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0004044', 'cui_str': 'Suffocation'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}]",97.0,0.014398,"There were no significant differences in reflux, asphyxia, bradycardia (<100 beats/min), apnea, FiO2, changes in PaO2 and PaCO2 at 1 hour post-treatment between the groups.","[{'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ""Neonatal Center, Beijing Children's Hospital, Capital Medical University, Beijing.""}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Hei', 'Affiliation': ""Neonatal Center, Beijing Children's Hospital, Capital Medical University, Beijing.""}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': ""Neonatal Internal Medicine, Children's Hospital of Shanxi, PR China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Neonatal Internal Medicine, Children's Hospital of Shanxi, PR China.""}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Neonatal Internal Medicine, Children's Hospital of Shanxi, PR China.""}, {'ForeName': 'Chenghu', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Neonatal Internal Medicine, Children's Hospital of Shanxi, PR China.""}]",Medicine,['10.1097/MD.0000000000019216']
460,31398376,"Change in self-efficacy, eating behaviors and food cravings during two years of calorie restriction in humans without obesity.","Calorie restriction (CR) enhances longevity in humans who are normal weight, overweight and obese. While dietary regimens can change self-efficacy, eating behaviors, and food cravings in individuals with obesity, the responses of these measures to prolonged CR in individuals who are exclusively not obese is unknown. The aim of this analysis was to test the effects of a two-year CR intervention on self-efficacy and eating attitudes and behaviors in humans without obesity by analyzing data from the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE 2) study. Participants (n = 218, BMI range = 21.3-29.0 kg/m 2 ) were randomized to a 25% CR group or an ad libitum (AL) group. Eating attitudes and behaviors and self-efficacy were assessed using validated questionnaires at baseline, month 12, and month 24. Dietary restraint and self-efficacy increased in the CR compared to the AL group (ES ≥ 0.32). Increased self-efficacy was negatively related to weight change (ρ < -0.24). In the CR group, males showed a reduction in cravings for carbohydrates and fats at month 24, whereas females did not. The CR group showed elevations in state hunger, which were transient, and disinhibited eating (ES ≥ 0.37). In individuals without obesity, dietary restraint and self-efficacy could be important in promoting long-term CR for individuals looking to use CR as a tool to improve longevity.",2019,Dietary restraint and self-efficacy increased in the CR compared to the AL group (ES ≥ 0.32).,"['humans who are normal weight, overweight and obese', 'Participants (n\u202f=\u202f218, BMI range\u202f=\u202f21.3-29.0\u202fkg/m 2 ', 'humans without obesity', 'individuals with obesity']","['two-year CR intervention', 'CR group or an ad libitum (AL', 'Calorie restriction (CR']","['Increased self-efficacy', 'Dietary restraint and self-efficacy', 'Eating attitudes and behaviors and self-efficacy', 'change self-efficacy, eating behaviors, and food cravings', 'weight change', 'self-efficacy and eating attitudes and behaviors', 'self-efficacy, eating behaviors and food cravings', 'cravings for carbohydrates and fats']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]",,0.0246942,Dietary restraint and self-efficacy increased in the CR compared to the AL group (ES ≥ 0.32).,"[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Dorling', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Manjushri', 'Initials': 'M', 'LastName': 'Bhapkar', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Jean Mayer, US Department of Agriculture, Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Racette', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Fearnbach', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Candice A', 'Initials': 'CA', 'LastName': 'Myers', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Tiffany M', 'Initials': 'TM', 'LastName': 'Stewart', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA. Electronic address: Corby.Martin@pbrc.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Appetite,['10.1016/j.appet.2019.104397']
461,31950979,"Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock: The VITAMINS Randomized Clinical Trial.","Importance


It is unclear whether vitamin C, hydrocortisone, and thiamine are more effective than hydrocortisone alone in expediting resolution of septic shock.
Objective


To determine whether the combination of vitamin C, hydrocortisone, and thiamine, compared with hydrocortisone alone, improves the duration of time alive and free of vasopressor administration in patients with septic shock.
Design, Setting, and Participants


Multicenter, open-label, randomized clinical trial conducted in 10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock. The first patient was enrolled on May 8, 2018, and the last on July 9, 2019. The final date of follow-up was October 6, 2019.
Interventions


Patients were randomized to the intervention group (n = 109), consisting of intravenous vitamin C (1.5 g every 6 hours), hydrocortisone (50 mg every 6 hours), and thiamine (200 mg every 12 hours), or to the control group (n = 107), consisting of intravenous hydrocortisone (50 mg every 6 hours) alone until shock resolution or up to 10 days.
Main Outcomes and Measures


The primary trial outcome was duration of time alive and free of vasopressor administration up to day 7. Ten secondary outcomes were prespecified, including 90-day mortality.
Results


Among 216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63%]). Time alive and vasopressor free up to day 7 was 122.1 hours (interquartile range [IQR], 76.3-145.4 hours) in the intervention group and 124.6 hours (IQR, 82.1-147.0 hours) in the control group; the median of all paired differences was -0.6 hours (95% CI, -8.3 to 7.2 hours; P = .83). Of 10 prespecified secondary outcomes, 9 showed no statistically significant difference. Ninety-day mortality was 30/105 (28.6%) in the intervention group and 25/102 (24.5%) in the control group (hazard ratio, 1.18; 95% CI, 0.69-2.00). No serious adverse events were reported.
Conclusions and Relevance


In patients with septic shock, treatment with intravenous vitamin C, hydrocortisone, and thiamine, compared with intravenous hydrocortisone alone, did not significantly improve the duration of time alive and free of vasopressor administration over 7 days. The finding suggests that treatment with intravenous vitamin C, hydrocortisone, and thiamine does not lead to a more rapid resolution of septic shock compared with intravenous hydrocortisone alone.
Trial Registration


ClinicalTrials.gov Identifier: NCT03333278.",2020,"No serious adverse events were reported.
","['Patients With Septic Shock', '216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63', '10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock', 'The first patient was enrolled on May 8, 2018, and the last on July 9, 2019', 'patients with septic shock']","['intravenous vitamin C, hydrocortisone, and thiamine', 'intravenous hydrocortisone', 'hydrocortisone alone', 'vitamin C, hydrocortisone, and thiamine', 'intravenous vitamin C', 'thiamine', 'hydrocortisone', 'Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone']","['Time alive and vasopressor free', 'Ninety-day mortality', 'duration of time alive and free of vasopressor administration up to day 7', 'serious adverse events', 'duration of time alive and free of vasopressor administration', 'Time Alive and Free of Vasopressor Support', '90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",216.0,0.416565,"No serious adverse events were reported.
","[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Luethi', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Frei', 'Affiliation': 'Department of Anaesthesia and Pain Medicine, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'French', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ludhmila A', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Oliveira', 'Affiliation': 'Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Udy', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Orford', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Edney', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Hunt', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Harriet L', 'Initials': 'HL', 'LastName': 'Judd', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thummaporn', 'Initials': 'T', 'LastName': 'Naorungroj', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Bates', 'Affiliation': 'Department of Intensive Care, Anaesthesia, Pain, and Perioperative Medicine, Footscray Hospital, Western Health, Footscray, Melbourne, Victoria, Australia.'}, {'ForeName': 'Forbes', 'Initials': 'F', 'LastName': 'McGain', 'Affiliation': 'Department of Intensive Care, Anaesthesia, Pain, and Perioperative Medicine, Footscray Hospital, Western Health, Footscray, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Hudson', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Wisam', 'Initials': 'W', 'LastName': 'Al-Bassam', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dhiraj Bhatia', 'Initials': 'DB', 'LastName': 'Dwivedi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Peppin', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'McCracken', 'Affiliation': 'Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Orosz', 'Affiliation': 'Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.22176']
462,32151236,Impact of initial flexor synergy pattern scores on improving upper extremity function in stroke patients treated with adjunct robotic rehabilitation: A randomized clinical trial.,"Background:  Robot-assisted rehabilitation is an appealing strategy for patients after stroke, as it generates repetitive movements in a consistent, precise, and automated manner.  Objective:  To identify patients who will benefit most from robotic rehabilitation for upper extremity (UE) hemiparesis.  Methods: We used data from our previous randomized clinical trial comparing 6 weeks of robotic therapy (ReoGeo system) plus standard therapy (n=30) with self-guided therapy plus standard therapy (n=26) for sub-acute phase rehabilitation in adults with mild to moderate UE hemiparesis. The outcome measures were three Fugl-Meyer (FMA) motor scores: total UE score, proximal UE score, and UE flexor synergy score. Based on pre-therapy UE flexor synergy scores, participants were categorized into mild (10-12 points), moderate (6-9 points), and severe (0-5 points) impairment classes.  Results:  In the robotic group, all outcome measures improved after therapy in patients with moderate or severe impairment. In the self-guided therapy, most outcomes did not improve, regardless of the impairment class. When changes from pre- to post-therapy were compared between robotic and self-guided groups, most outcomes were similar in all impairment classes. However, robotic therapy was associated with greater improvement in UE flexor synergy than self-guided therapy in patients with moderate impairment (2.3±1.3 vs. -0.1±2.8, P=0.027).  Conclusions:  Post-strokerobot-assisted rehabilitation, as an adjunct to standard rehabilitation therapy, improved UE function in patients with moderate or severe pre-therapy UE flexor synergy impairment. Adjunct robotic therapy produced greater improvement in UE flexor synergy motor function than adjunct self-guided rehabilitation in patients with moderate pre-therapy impairment.",2020,Adjunct robotic therapy produced greater improvement in UE flexor synergy motor function than adjunct self-guided rehabilitation in patients with moderate pre-therapy impairment.,"['adults with mild to moderate UE hemiparesis', 'patients who will benefit most from robotic rehabilitation for upper extremity (UE) hemiparesis', 'participants were categorized into mild (10-12 points), moderate (6-9 points), and severe (0-5 points) impairment classes', 'stroke patients treated with adjunct robotic rehabilitation', 'patients with moderate or severe impairment', 'patients\xa0with moderate pre-therapy impairment', 'patients\xa0with moderate or severe pre-therapy UE flexor synergy impairment']","['Adjunct robotic therapy', 'robotic therapy (ReoGeo system) plus standard therapy (n=30) with self-guided therapy plus standard therapy', 'Post-strokerobot-assisted rehabilitation', ': \xa0Robot-assisted rehabilitation', 'initial flexor synergy pattern scores']","['UE flexor synergy motor function', 'Fugl-Meyer (FMA) motor scores: total\xa0UE score, proximal UE score, and UE flexor synergy score', 'UE flexor synergy', 'UE function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1290903', 'cui_str': 'Impairment class'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",30.0,0.0933102,Adjunct robotic therapy produced greater improvement in UE flexor synergy motor function than adjunct self-guided rehabilitation in patients with moderate pre-therapy impairment.,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Takebayashi', 'Affiliation': 'School of Comprehensive Rehabilitation, College of Health and Human Science, Osaka Prefecture University , Osaka, Japan.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Occupational Therapy, School of Allied Health Science, Kitasato University , Kanagawa, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Science, Hyogo College of Medicine , Hyogo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hachisuka', 'Affiliation': 'Moji Medical Center , Fukuoka, Japan.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2020.1738660']
463,32147082,Effects of acupuncture treatment on motor function in patients with subacute hemorrhagic stroke: A randomized controlled study.,"OBJECTIVE


The aim of this study was to evaluate the additional effects of acupuncture treatment on motor function in patients with subacute hemorrhagic stroke.
DESIGN


One hundred and thirty-four patients with subacute hemorrhagic stroke were randomized to receive acupuncture treatment plus conventional treatment (treatment group) or conventional treatment only (control group). Acupuncture treatments were given in 24 sessions over 4 weeks, with 3-month follow-up period. Blinded evaluation was based on Fugl-Meyer Assessment, Barthel Index with an intention-to-treat analysis. For those patients who were able to walk, a three-dimensional gait analysis system was employed to objectively record spatiotemporal and kinematic parameters.
RESULTS


Compared with control group, the treatment group showed a significantly greater over-time improvement in total Fugl-Meyer, lower-limb Fugl-Meyer, but not in upper-limb Fugl-Meyer and Barthel Index. The spatiotemporal parameters of velocity, step length, cadence, step width all showed significant difference between the 2 groups. The velocity in treatment group decreased unexpectedly at day 14, then increased sharply and overcame control group at day 28. The treatment group also showed a significantly greater increase in peak circumduction, peak hip hiking, hip range of motion, knee range of motion and a tendency for the ankle range of motion.
CONCLUSIONS


Acupuncture may promote the motor function recovery of hemorrhagic stroke patients in subacute phase mainly by enhancing the lower limb ability. It probably diminishes the compensation strategies earlier to correct the abnormal gait pattern. Although this adjustment may result in a compromise in the improvement of gait velocity temporarily, patients would benefit from it in a long run.",2020,"The treatment group also showed a significantly greater increase in peak circumduction, peak hip hiking, hip range of motion, knee range of motion and a tendency for the ankle range of motion.
","['One hundred and thirty-four patients with subacute hemorrhagic stroke', 'patients with subacute hemorrhagic stroke', 'hemorrhagic stroke patients']","['acupuncture', 'Acupuncture', 'acupuncture treatment plus conventional treatment (treatment group) or conventional treatment only (control group', 'acupuncture treatment']","['peak circumduction, peak hip hiking, hip range of motion, knee range of motion and a tendency for the ankle range of motion', 'motor function', 'spatiotemporal parameters of velocity, step length, cadence, step width', 'time improvement in total Fugl-Meyer, lower-limb Fugl-Meyer, but not in upper-limb Fugl-Meyer and Barthel Index']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231464', 'cui_str': 'Circumduction, function (observable entity)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0576002', 'cui_str': 'Joint movement: hip'}, {'cui': 'C0576094', 'cui_str': 'Knee range of motion'}, {'cui': 'C0576183', 'cui_str': 'Joint movement: ankle'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}]",134.0,0.0459529,"The treatment group also showed a significantly greater increase in peak circumduction, peak hip hiking, hip range of motion, knee range of motion and a tendency for the ankle range of motion.
","[{'ForeName': 'Hai-Qiao', 'Initials': 'HQ', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, South Campus, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. Electronic address: haiqiaodr@163.com.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': ""Department of Neurology & Rehabilitation, Qingdao Women & Children's Hospital, Qingdao University, Qingdao, China.""}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Traditional Chinese Medicine, South Campus, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Chun-Ling', 'Initials': 'CL', 'LastName': 'Bao', 'Affiliation': 'Department of Acupuncture, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Min', 'Affiliation': 'Department of Traditional Chinese Medicine, South Campus, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Gui-Rong', 'Initials': 'GR', 'LastName': 'Dong', 'Affiliation': 'Department of Acupuncture, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zhi-Hua', 'Initials': 'ZH', 'LastName': 'Jiao', 'Affiliation': 'Department of Acupuncture, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2019.102296']
464,31471001,Efficacy of a Web-Based Intervention to Increase Uptake of Maternal Vaccines: An RCT.,"INTRODUCTION


Tetanus, diphtheria, and acellular pertussis (Tdap) and influenza vaccines are recommended for pregnant women in each pregnancy, yet uptake is suboptimal. This study tested the efficacy of an online vaccine resource in increasing uptake of Tdap and influenza vaccines among pregnant women.
STUDY DESIGN


RCT.
SETTING/PARTICIPANTS


This study was conducted among women in the third trimester of pregnancy in an integrated healthcare system in Colorado in September 2013-July 2016, with data analysis in 2017-2018.
INTERVENTION


Women were randomly assigned to 1 of 3 arms: website with vaccine information and interactive social media components, website with vaccine information only, or usual care. Participants in the website with vaccine information and interactive social media components and website with vaccine information only arms had access to the same base vaccine content. The website with vaccine information and interactive social media components also included a blog, discussion forum, and ""Ask a Question"" portal.
MAIN OUTCOME MEASURES


Tdap and influenza vaccination. These outcomes were analyzed separately.
RESULTS


For influenza (n=289), women in both the website with vaccine information and interactive social media components (OR=2.19, 95% CI=1.06, 4.53) and website with vaccine information only (OR=2.20, 95% CI=1.03, 4.69) arms had higher vaccine uptake than the usual care arm. The proportions of women receiving the influenza vaccine were 57%, 55%, and 36% in the website with vaccine information and interactive social media components, website with vaccine information only, and usual care arms, respectively. For Tdap (n=173), there were no significant differences in vaccine uptake between study arms. The proportions of women receiving Tdap were 71%, 69%, and 68% in the website with vaccine information and interactive social media components, website with vaccine information only, and usual care arms, respectively.
CONCLUSIONS


Web-based vaccination information sent to pregnant women can positively influence maternal influenza vaccine uptake. Because of potential scalability, the impact of robust vaccination information websites should be studied in other settings.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT01873040.",2019,"For Tdap (n=173), there were no significant differences in vaccine uptake between study arms.","['pregnant women', 'women in the third trimester of pregnancy in an integrated healthcare system in Colorado in September 2013-July 2016, with data analysis in 2017-2018', 'pregnant women in each pregnancy']","['Web-Based Intervention', 'diphtheria, and acellular pertussis (Tdap) and influenza vaccines', 'vaccine information and interactive social media components, website with vaccine information only, or usual care', 'online vaccine resource', 'influenza vaccine']","['Increase Uptake of Maternal Vaccines', 'maternal influenza vaccine uptake', 'vaccine uptake']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]",,0.110401,"For Tdap (n=173), there were no significant differences in vaccine uptake between study arms.","[{'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Pediatrics, University of Colorado, Aurora, Colorado. Electronic address: sean.oleary@ucdenver.edu.'}, {'ForeName': 'Komal J', 'Initials': 'KJ', 'LastName': 'Narwaney', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Wagner', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Kraus', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Glanz', 'Affiliation': 'Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado; Department of Epidemiology, Colorado School of Public Health, University of Colorado Denver, Aurora, Colorado.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.05.018']
465,32152811,"Inter-study repeatability of circumferential strain and diastolic strain rate by CMR tagging, feature tracking and tissue tracking in ST-segment elevation myocardial infarction.","Strain assessment allows accurate evaluation of myocardial function and mechanics in ST-segment elevation myocardial infarction (STEMI). Strain using cardiovascular magnetic resonance (CMR) has traditionally been assessed with tagging but limitations of this technique have led to more widespread use of alternative methods, which may be more robust. We compared the inter-study repeatability of circumferential global peak-systolic strain (Ecc) and peak-early diastolic strain rate (PEDSR) derived by tagging with values obtained using novel cine-based software: Feature Tracking (FT) (TomTec, Germany) and Tissue Tracking (TT) (Circle cvi 42 , Canada) in patients following STEMI. Twenty male patients (mean age 56 ± 10 years, mean infarct size 13.7 ± 7.1% of left ventricular mass) were randomised to undergo CMR 1-5 days post-STEMI at 1.5 T or 3.0 T, repeated after ten minutes at the same field strength. Ecc and PEDSR were assessed using tagging, FT and TT. Inter-study repeatability was evaluated using Bland-Altman analyses, coefficients of variation (CoV) and intra-class correlation coefficient (ICC). Ecc (%) was significantly lower with tagging than with FT or TT at 1.5 T (- 9.5 ± 3.3 vs. - 17.5 ± 3.8 vs. -15.5 ± 5.2, respectively, p < 0.001) and 3.0 T (- 13.1 ± 1.8 vs. - 19.4 ± 2.9 vs. - 17.3 ± 2.1, respectively, p = 0.001). This was similar for PEDSR (.s -1 ): 1.5 T (0.6 ± 0.2 vs. 1.5 ± 0.4 vs. 1.0 ± 0.4, for tagging, FT and TT respectively, p < 0.001) and 3.0 T (0.6 ± 0.2 vs. 1.5 ± 0.3 vs. 0.9 ± 0.3, respectively, p < 0.001). Inter-study repeatability for Ecc at 1.5 T was good for tagging and excellent for FT and TT: CoV 16.7%, 6.38%, and 8.65%, respectively. Repeatability for Ecc at 3.0 T was good for all three techniques: CoV 14.4%, 11.2%, and 13.0%, respectively. However, repeatability of PEDSR was generally lower than that for Ecc at 1.5 T (CoV 15.1%, 13.1%, and 34.0% for tagging, FT and TT, respectively) and 3.0 T (CoV 23.0%, 18.6%, and 26.2%, respectively). Following STEMI, Ecc and PEDSR are higher when measured with FT and TT than with tagging. Inter-study repeatability of Ecc is good for tagging, excellent for FT and TT at 1.5 T, and good for all three methods at 3.0 T. The repeatability of PEDSR is good to moderate at 1.5 T and moderate at 3.0 T. Cine-based methods to assess Ecc following STEMI may be preferable to tagging.",2020,Inter-study repeatability for Ecc at 1.5 T was good for tagging and excellent for FT and TT:,"['Twenty male patients (mean age 56\u2009±\u200910\xa0years, mean infarct size 13.7\u2009±\u20097.1% of left ventricular mass', 'ST-segment elevation myocardial infarction']","['cardiovascular magnetic resonance (CMR', 'tagging with values obtained using novel cine-based software: Feature Tracking (FT) (TomTec, Germany) and Tissue Tracking (TT', 'circumferential strain and diastolic strain rate by CMR tagging, feature tracking and tissue tracking', 'TT']","['circumferential global peak-systolic strain (Ecc) and peak-early diastolic strain rate (PEDSR', 'repeatability of PEDSR', 'coefficients of variation (CoV) and intra-class correlation coefficient (ICC', 'Ecc and PEDSR']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}]","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]",20.0,0.0337012,Inter-study repeatability for Ecc at 1.5 T was good for tagging and excellent for FT and TT:,"[{'ForeName': 'Sheraz A', 'Initials': 'SA', 'LastName': 'Nazir', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK. sn191@le.ac.uk.'}, {'ForeName': 'Abhishek M', 'Initials': 'AM', 'LastName': 'Shetye', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Jamal N', 'Initials': 'JN', 'LastName': 'Khan', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Anvesha', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Jayanth R', 'Initials': 'JR', 'LastName': 'Arnold', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Squire', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health for Research (NIHR) Leicester Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, LE3 9QF, UK.'}]",The international journal of cardiovascular imaging,['10.1007/s10554-020-01806-8']
466,32151503,Modified constraint-induced movement therapy during hospitalization in children with perinatal brachial plexus palsy: A randomized controlled trial.,"STUDY DESIGN


Prospective single-blind, randomized controlled study.
INTRODUCTION


Children with perinatal brachial plexus palsy (PBPP) have motion limitations in the affected upper extremity. Modified constraint-induced movement therapy (mCIMT) is one of the treatment options used for the improvement of the function of the affected limb.
PURPOSE OF THE STUDY


The purpose of this study was to compare the effect of mCIMT and conventional therapy in improving active range of motion (ROM) and functional use of the affected upper extremity in children with PBPP with injuries to upper and middle trunks in the hospital environment.
MATERIALS


26 patients received conventional rehabilitation program (control group) and 13 patients participated in a mCIMT program (study group). Children had a mean age 56.3 months (range 4-10 years). The mCIMT included 1 hour therapy sessions emphasizing the affected arm use for 14 consecutive days during hospitalization. Their normal arm was also constrained for 6 hour per day. All the patients were assessed at the baseline, one day, one month, and three months after completion of therapy using active ROM, active movement scale, hand dynamometer, box and blocks test.
RESULTS


The mCIMT group improved more than the control group in shoulder internal rotation, forearm supination, elbow flexion active ROMs, hand grip strength, and in upper extremity function.
CONCLUSION


mCIMT has a potential to promote functional gains for children with PBPP; this approach should be widely applied within routine clinical practice.",2020,"The mCIMT group improved more than the control group in shoulder internal rotation, forearm supination, elbow flexion active ROMs, hand grip strength, and in upper extremity function.
","['Children had a mean age 56.3 months (range 4-10 years', 'Children with perinatal brachial plexus palsy (PBPP', '26 patients received', 'children with PBPP with injuries to upper and middle trunks in the hospital environment', 'children with PBPP', 'children with perinatal brachial plexus palsy']","['conventional rehabilitation program (control group) and 13 patients participated in a mCIMT program', 'Modified constraint-induced movement therapy', 'mCIMT and conventional therapy', 'Modified constraint-induced movement therapy (mCIMT', 'mCIMT']","['active range of motion (ROM', 'shoulder internal rotation, forearm supination, elbow flexion active ROMs, hand grip strength, and in upper extremity function', 'active ROM, active movement scale, hand dynamometer, box and blocks test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006090', 'cui_str': 'Brachial Plexus'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0231481', 'cui_str': 'Active movement (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",26.0,0.0262725,"The mCIMT group improved more than the control group in shoulder internal rotation, forearm supination, elbow flexion active ROMs, hand grip strength, and in upper extremity function.
","[{'ForeName': 'Beyhan', 'Initials': 'B', 'LastName': 'Eren', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Marmaris State Hospital, Muğla, Turkey. Electronic address: beyhan89@yahoo.com.'}, {'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Karadağ Saygı', 'Affiliation': 'Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Tokgöz', 'Affiliation': 'Physical Medicine and Rehabilitation Department, School of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Akdeniz Leblebicier', 'Affiliation': 'Physical Medicine and Rehabilitation Department, School of Medicine, Dumlupınar University, Kütahya, Turkey.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.12.008']
467,31729976,"A randomized trial to evaluate a modified tracheal catheter with upper and lower balloons for anesthetic administration: effect on the cardiovascular, stress response, and comfort in patients undergoing laparoscopic cholecystectomy.","BACKGROUND


We aimed to evaluate a modified endotracheal tube containing upper and lower balloons for anesthetic administration among patients undergoing laparoscopic cholecystectomy.
METHODS


Ninety patients scheduled to undergo laparoscopic cholecystectomy were randomly allocated to 3 equal groups: group A (conventional tracheal intubation without endotracheal anesthesia); B (conventional tracheal intubation with endotracheal anesthesia); and C (tracheal intubation using a modified catheter under study). Blood pressure, heart rate, angiotensin II level, blood glucose level, airway pressure before anesthesia (T1) were measured immediately after intubation (T2), 5 min after intubation (T3), and immediately after extubation (T4). The post-extubation pain experienced was evaluated using the Wong-Baker Face Pain scale. Adverse reactions within 30 min after extubation were recorded.
RESULTS


Systolic blood pressure, diastolic blood pressure, angiotensin II, and blood sugar level in group C at T2, T3 and T4, and heart rate at T2 and T4 were significantly lower than those in group A (P < 0.05); systolic blood pressure and blood sugar at T4, and angiotensin II levels at T2, T3, and T4 were significantly lower than those in group B (P < 0.05). Patients in group C reported the lowest post-extubation pain (P < 0.05 vs. Group A), and the lowest incidence of adverse events such as nausea, vomiting, and sore throat than that in groups A and B (P < 0.05).
CONCLUSION


The modified endotracheal anesthesia tube under study is effective in reducing cardiovascular and tracheal stress response, and increasing patient comfort, without inducing an increase in airway resistance.
TRIAL REGISTRATION


The clinical trial was retrospectively registered at the Chinese Clinical Trial Registry with the Registration Number ChiCTR1900020832 at January 20th 2019.",2019,"Patients in group C reported the lowest post-extubation pain (P < 0.05 vs. Group A), and the lowest incidence of adverse events such as nausea, vomiting, and sore throat than that in groups A and B (P < 0.05).
","['patients undergoing laparoscopic cholecystectomy', 'Ninety patients scheduled to undergo']","['modified endotracheal tube containing upper and lower balloons', 'modified tracheal catheter with upper and lower balloons for anesthetic administration', '3 equal groups: group A (conventional tracheal intubation without endotracheal anesthesia); B (conventional tracheal intubation with endotracheal anesthesia); and C (tracheal intubation', 'laparoscopic cholecystectomy']","['Blood pressure, heart rate, angiotensin II level, blood glucose level, airway pressure before anesthesia (T1', 'Baker Face Pain scale', 'Systolic blood pressure, diastolic blood pressure, angiotensin II, and blood sugar level', 'cardiovascular, stress response, and comfort', 'cardiovascular and tracheal stress response', 'heart rate at T2 and T4', 'lowest post-extubation pain', 'Adverse reactions', 'systolic blood pressure and blood sugar at T4, and angiotensin II levels', 'nausea, vomiting, and sore throat']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0002919', 'cui_str': 'Anesthesia, Intratracheal'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood (procedure)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2945595', 'cui_str': 'Tracheal (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}]",90.0,0.0430495,"Patients in group C reported the lowest post-extubation pain (P < 0.05 vs. Group A), and the lowest incidence of adverse events such as nausea, vomiting, and sore throat than that in groups A and B (P < 0.05).
","[{'ForeName': 'Yuenong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""First Department of Anesthesiology, People's Hospital of Meizhou City, Meizhou, Guangdong Province, China.""}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': ""First Department of Anesthesiology, People's Hospital of Meizhou City, Meizhou, Guangdong Province, China. mz19700720@163.com.""}, {'ForeName': 'Guangwen', 'Initials': 'G', 'LastName': 'Xiao', 'Affiliation': 'Department of Laboratory Medicine, Jiaying University of Meizhou City, Meizhou, Guangdong Province, China.'}, {'ForeName': 'Weiqiang', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""First Department of Anesthesiology, People's Hospital of Meizhou City, Meizhou, Guangdong Province, China.""}, {'ForeName': 'Weixiong', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ""First Department of Anesthesiology, People's Hospital of Meizhou City, Meizhou, Guangdong Province, China.""}, {'ForeName': 'Jingdan', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': ""First Department of Anesthesiology, People's Hospital of Meizhou City, Meizhou, Guangdong Province, China.""}]",BMC anesthesiology,['10.1186/s12871-019-0883-7']
468,31718957,"Mirabegron Add-on Therapy to Tamsulosin for the Treatment of Overactive Bladder in Men with Lower Urinary Tract Symptoms: A Randomized, Placebo-controlled Study (MATCH).","BACKGROUND


Men with lower urinary tract symptoms (LUTS) treated with α-blockers (eg, tamsulosin) may experience overactive bladder (OAB) symptoms and receive add-on antimuscarinics. Mirabegron (a β3-adrenoreceptor agonist) is an alternative add-on therapy.
OBJECTIVE


To evaluate the efficacy of mirabegron versus placebo in men with OAB symptoms receiving tamsulosin for LUTS.
DESIGN, SETTING, AND PARTICIPANTS


Japanese and Korean men with OAB treated with tamsulosin for LUTS (January 2016-July 2017).
INTERVENTION


Single-blind, 4-wk screening: tamsulosin plus placebo orally once daily; double-blind, 12-wk treatment: patients randomized (n=568) to mirabegron 50mg or placebo, as add-on to tamsulosin.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Primary endpoint: baseline to end of treatment (EoT) change in the mean number of micturitions/24h, based on a 3-d voiding diary. Secondary endpoints: change in other diary variables and patient-reported outcomes from baseline to EoT. The primary endpoint was analyzed by analysis of covariance, including treatment group and region as fixed factors and baseline as a covariate.
RESULTS AND LIMITATIONS


Mirabegron add-on therapy was superior to placebo in improving the primary endpoint (adjusted mean difference [95% confidence interval] vs placebo -0.52 [-0.82 to -0.21]) and secondary endpoints, including mean volume voided/micturition (12.08 [6.33-17.84]), OAB symptom score (-0.65 [-1.04 to -0.26]), International Prostate Symptom Score total (-1.19 [-1.94 to -0.44]), storage (-0.78 [-1.13 to -0.43]), quality of life scores (-0.29 [-0.51 to -0.07]), OAB symptom bother (-4.52 [-6.91 to -2.13]), and total health-related quality of life (2.79 [1.13 to 4.44]). Differences, compared with placebo, in urgency, urgency urinary incontinence, and nocturia were not statistically significant. Mirabegron was well tolerated, with no major safety concerns. Limitations included a lack of antimuscarinic comparison.
CONCLUSIONS


The mirabegron add-on therapy to tamsulosin for 12 wk in men with LUTS and OAB symptoms demonstrated superior efficacy to placebo and was well tolerated.
PATIENT SUMMARY


We looked at the efficacy and safety of mirabegron compared with placebo in men being treated with tamsulosin but who still had overactive bladder symptoms. Mirabegron improved overactive bladder symptoms and patient-reported outcomes compared with placebo, and was well tolerated.",2020,Mirabegron add-on therapy was superior to placebo in improving the primary endpoint (adjusted mean difference [95% confidence interval] vs placebo -0.52,"['Japanese and Korean men with OAB treated with tamsulosin for LUTS (January 2016-July 2017', 'men being treated with tamsulosin but who still had overactive bladder symptoms', 'Men with lower urinary tract symptoms (LUTS) treated with', 'men with OAB symptoms receiving tamsulosin for LUTS', 'Men with Lower Urinary Tract Symptoms']","['Placebo', 'Mirabegron (a β3-adrenoreceptor agonist', 'Tamsulosin', 'placebo', 'α-blockers (eg, tamsulosin', 'mirabegron 50mg or placebo', 'mirabegron versus placebo', 'tamsulosin plus placebo', 'tamsulosin']","['International Prostate Symptom Score total', 'tolerated', 'OAB symptom score', 'urgency, urgency urinary incontinence, and nocturia', 'efficacy and safety', 'mean volume voided/micturition', 'baseline to end of treatment (EoT) change in the mean number of micturitions/24h, based on a 3-d voiding diary', 'quality of life scores', 'overactive bladder symptoms', 'total health-related quality of life', 'OAB symptom bother']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C3474335', 'cui_str': 'mirabegron 50 MG'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034380'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.490859,Mirabegron add-on therapy was superior to placebo in improving the primary endpoint (adjusted mean difference [95% confidence interval] vs placebo -0.52,"[{'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Kakizaki', 'Affiliation': 'Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Kyu-Sung', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamamoto', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Jar Jar', 'Initials': 'JJ', 'LastName': 'Jong', 'Affiliation': 'Astellas Pharma, Singapore.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Katou', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan. Electronic address: daisuke.katou@astellas.com.'}, {'ForeName': 'Budiwan', 'Initials': 'B', 'LastName': 'Sumarsono', 'Affiliation': 'Astellas Pharma, Singapore.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Uno', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Bioengineering and LUTD Research, Nihon University School of Engineering, Koriyama, Japan.'}]",European urology focus,['10.1016/j.euf.2019.10.019']
469,31837126,"Do comorbidities predict pain and function in knee osteoarthritis following an exercise intervention, and do they moderate the effect of exercise? Analyses of data from three randomized controlled trials.","BACKGROUND


Although exercise is a core treatment for people with knee osteoarthritis (OA), it is currently unknown whether those with additional comorbidities respond differently to exercise than those without. We explored whether comorbidities predict pain and function following an exercise intervention in people with knee OA, and whether they moderate response to: exercise versus no exercise; and enhanced exercise versus usual exercise-based care.
METHODS


We undertook analyses of existing data from three randomized controlled trials (RCTs): TOPIK (n = 217), APEX (n = 352) and Benefits of Effective Exercise for knee Pain (BEEP) (n = 514). All three RCTs included: adults with knee pain attributable to OA; physiotherapy-led exercise; data on six comorbidities (overweight/obesity, pain elsewhere, anxiety/depression, cardiac problems, diabetes mellitus and respiratory conditions); the outcomes of interest (six-month Western Ontario and McMaster Universities Arthritis Index knee pain and function). Adjusted mixed models were fitted where data was available; otherwise linear regression models were used.
RESULTS


Obesity compared with underweight/normal body mass index was significantly associated with knee pain following exercise, as was the presence compared with absence of anxiety/depression. The presence of cardiac problems was significantly associated with the effect of enhanced versus usual exercise-based care for knee function, indicating that enhanced exercise may be less effective for improving knee function in people with cardiac problems. Associations for all other potential prognostic factors and moderators were weak and not statistically significant.
CONCLUSIONS


Obesity and anxiety/depression predicted pain and function outcomes in people offered an exercise intervention, but only the presence of cardiac problems might moderate the effect of exercise for knee OA. Further confirmatory investigations are required.",2020,"The presence of cardiac problems was significantly associated with the effect of enhanced versus usual exercise-based care for knee function, indicating that enhanced exercise may be less effective for improving knee function in people with cardiac problems.","['people with knee OA', 'All three RCTs included: adults with knee pain attributable to OA; physiotherapy-led exercise; data on six comorbidities (overweight/obesity, pain elsewhere, anxiety/depression, cardiac problems, diabetes mellitus and respiratory conditions', 'people with cardiac problems', 'people with knee osteoarthritis (OA']","['exercise versus no exercise; and enhanced exercise versus usual exercise-based care', 'exercise intervention']",['knee pain'],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}]",514.0,0.0978034,"The presence of cardiac problems was significantly associated with the effect of enhanced versus usual exercise-based care for knee function, indicating that enhanced exercise may be less effective for improving knee function in people with cardiac problems.","[{'ForeName': 'Amardeep', 'Initials': 'A', 'LastName': 'Legha', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Keele, UK.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Burke', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Keele, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Keele, UK.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'van der Windt', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Keele, UK.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Quicke', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Keele, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Healey', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Keele, UK.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Runhaar', 'Affiliation': 'Department of General Practice, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Holden', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care & Health Sciences, Keele University, Keele, UK.'}]",Musculoskeletal care,['10.1002/msc.1425']
470,31745072,High-dose eicosapentaenoic acid (EPA) improves attention and vigilance in children and adolescents with attention deficit hyperactivity disorder (ADHD) and low endogenous EPA levels.,"No studies have examined the relationship between endogenous polyunsaturated fatty acids (PUFAs) levels and treatment response to PUFAs. We conducted a 12-week, double-blind, placebo-controlled trial comparing the effects of high-dose eicosapentaenoic acid (EPA, 1.2 g) and placebo on cognitive function (continuous performance test) in n = 92 youth (age 6-18-years-old) with Attention Deficit Hyperactivity Disorder (ADHD). Blood erythrocytes PUFAs were measured before and after treatment, to examine the effects of baseline endogenous EPA levels on treatment response and the effects of EPA treatment on PUFAs levels. Secondary measures included other ADHD symptoms, emotional symptoms, and levels of plasma high-sensitivity c-reactive protein (hs-CRP) and brain-derived neurotrophic factor (BDNF). Overall, EPA group improved more than placebo group on focused attention (variability, Effect size (ES) = 0.38, p = 0.041); moreover, within youth with the lowest baseline endogenous EPA levels, EPA group improved more than placebo group in another measure of focused attention (hit reaction time, HRT, ES = 0.89, p = 0.015) and in vigilance (HRT interstimulus interval changes, HRTISIC, ES = 0.83, p = 0.036). Interestingly, EPA group improved less than placebo group in impulsivity (commission errors), both overall and in youth with the highest baseline EPA levels, who also showed less improvement in other ADHD and emotional symptoms. EPA increased blood erythrocytes EPA by 1.6-fold but not DHA levels, and did not affect hs-CRP and BDNF plasma levels. In conclusion, EPA treatment improves cognitive symptoms in ADHD youth, especially if they have a low baseline endogenous EPA level, while youth with high EPA levels may be negatively affected by this treatment.",2019,"EPA increased blood erythrocytes EPA by 1.6-fold but not DHA levels, and did not affect hs-CRP and BDNF plasma levels.","['children and adolescents with attention deficit hyperactivity disorder (ADHD', 'n\u2009=\u200992 youth (age 6-18-years-old) with Attention Deficit Hyperactivity Disorder (ADHD']","['placebo', 'eicosapentaenoic acid (EPA', 'high-dose eicosapentaenoic acid (EPA, 1.2\u2009g) and placebo', 'EPA']","['blood erythrocytes EPA', 'endogenous polyunsaturated fatty acids (PUFAs) levels', 'ADHD and emotional symptoms', 'cognitive symptoms', 'Blood erythrocytes PUFAs', 'impulsivity (commission errors', 'hs-CRP and BDNF plasma levels', 'vigilance (HRT interstimulus interval changes', 'cognitive function (continuous performance test', 'PUFAs levels', 'ADHD symptoms, emotional symptoms, and levels of plasma high-sensitivity c-reactive protein (hs-CRP) and brain-derived neurotrophic factor (BDNF']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}]","[{'cui': 'C0005768'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",92.0,0.570182,"EPA increased blood erythrocytes EPA by 1.6-fold but not DHA levels, and did not affect hs-CRP and BDNF plasma levels.","[{'ForeName': 'Jane Pei-Chen', 'Initials': 'JP', 'LastName': 'Chang', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK.""}, {'ForeName': 'Kuan-Pin', 'Initials': 'KP', 'LastName': 'Su', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK. cobolsu@gmail.com.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Mondelli', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK.""}, {'ForeName': 'Senthil Kumaran', 'Initials': 'SK', 'LastName': 'Satyanarayanan', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hui-Ting', 'Initials': 'HT', 'LastName': 'Yang', 'Affiliation': 'College of Nutrition, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Chiang', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hui-Ting', 'Initials': 'HT', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Carmine M', 'Initials': 'CM', 'LastName': 'Pariante', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, WC2R 2LS, UK.""}]",Translational psychiatry,['10.1038/s41398-019-0633-0']
471,31704458,Accuracy of Patient Reported Stone Passage for Patients With Acute Renal Colic Treated in the Emergency Department.,"OBJECTIVE


To study patients who initially presented to the Emergency Department with acute renal colic to determine if patient-reported stone passage detects stone expulsion as accurately as follow-up computed tomography (CT) scan.
METHODS


This is a secondary analysis of a multi-center prospective trial of patients diagnosed by a CT scan with a symptomatic ureteral stone <9 mm in diameter. Patient-reported stone passage, defined as capture or visualization of the stone, was compared to CT scan-confirmed passage performed 29-36 days after initial presentation.
RESULTS


Four-hundred-three patients were randomized in the original study and 21 were excluded from this analysis because they were lost to follow-up or received ureteroscopic surgery. Of the 382 remaining evaluable patients, 237 (62.0%) underwent a follow-up CT scan. The mean (standard deviation) diameter of the symptomatic kidney stone was 3.8 mm (1.4). In those who reported stone passage, 93.8% (91/97) demonstrated passage of the symptomatic ureteral stone on follow-up CT. Of patients who did not report stone passage, 72.1% (101/140) demonstrated passage of their stone on follow-up CT.
CONCLUSIONS


For patients who report capture or visualization of a ureteral stone, a follow-up CT scan may not be needed to verify stone passage. For patients who do not capture their stone or visualize stone passage, imaging should be considered to confirm passage.",2020,"Of patients who did not report stone passage, 72.1% (101/140) demonstrated passage of their stone on follow-up CT.
","['patients with acute renal colic treated in the emergency department', 'patients diagnosed by a CT scan with a symptomatic ureteral stone <9mm in diameter', 'patients who initially presented to the Emergency Department with acute renal colic to determine if patient-reported stone passage detects stone expulsion as accurately as follow-up computed tomography (CT) scan', '403 patients were randomized in the original study and 21 were excluded from this analysis because they were lost to follow-up or received']",['ureteroscopic surgery'],"['passage of the symptomatic ureteral stone', 'mean (standard deviation) diameter of the symptomatic kidney stone', 'passage of their stone']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0401343', 'cui_str': 'Surgical Procedures, Ureteroscopic'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]",403.0,0.0284206,"Of patients who did not report stone passage, 72.1% (101/140) demonstrated passage of their stone on follow-up CT.
","[{'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Meltzer', 'Affiliation': 'Department of Emergency Medicine, George Washington University School of Medicine & Health Sciences, Washington, DC. Electronic address: ameltzer@mfa.gwu.edu.'}, {'ForeName': 'Pamela Katzen', 'Initials': 'PK', 'LastName': 'Burrows', 'Affiliation': 'The George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Kirkali', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Judd E', 'Initials': 'JE', 'LastName': 'Hollander', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kurz', 'Affiliation': 'Department of Emergency Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mufarrij', 'Affiliation': 'Department of Urology, George Washington University School of Medicine & Health Sciences, Washington, DC.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Wolfson', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'MacPherson', 'Affiliation': 'The George Washington University Biostatistics Center, Washington, DC.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hubosky', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Montano', 'Affiliation': 'Department of Emergency Medicine, George Washington University School of Medicine & Health Sciences, Washington, DC.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Jackman', 'Affiliation': 'Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}]",Urology,['10.1016/j.urology.2019.10.010']
472,31777008,Cost-Effectiveness of Sertraline in Primary Care According to Initial Severity and Duration of Depressive Symptoms: Findings from the PANDA RCT.,"BACKGROUND


Antidepressants are commonly prescribed for depression, but it is unclear whether treatment efficacy depends on severity and duration of symptoms and how prescribing might be targeted cost-effectively.
OBJECTIVES


We investigated the cost-effectiveness of the antidepressant sertraline compared with placebo in subgroups defined by severity and duration of depressive symptoms.
METHODS


We undertook a cost-effectiveness analysis from the perspective of the NHS and Personal and Social Services (PSS) in the UK alongside the PANDA (What are the indications for Prescribing ANtiDepressants that will leAd to a clinical benefit?) randomised controlled trial (RCT), which compared sertraline with placebo over a 12-week period. Quality of life data were collected at baseline and at 2, 6, and 12 weeks post-randomisation using EQ-5D-5L, from which we calculated quality-adjusted life years (QALYs). Costs (in 2017/18£) were collected using patient records and from resource use questionnaires administered at each follow-up interval. Differences in mean costs and mean QALYs and net monetary benefits were estimated. Our primary analysis used net monetary benefit regressions to identify any interaction between the cost-effectiveness of sertraline and subgroups defined by baseline symptom severity (0-11; 12-19; 20+ on the Clinical Interview Schedule-Revised) and, separately, duration of symptoms (greater or less than 2 years duration). A secondary analysis estimated the cost-effectiveness of sertraline versus placebo, irrespective of duration or severity.
RESULTS


There was no evidence of an association between the baseline severity of depressive symptoms and the cost-effectiveness of sertraline. Compared to patients with low symptom severity, the expected net benefits in patients with moderate symptoms were £24 (95% CI - £280 to £328; p value 0.876) and the expected net benefits in patients with high symptom severity were £37 (95% CI - £221 to £296; p value 0.776). Patients who had a longer history of depressive symptoms at baseline had lower expected net benefits from sertraline than those with a shorter history; however, the difference was uncertain (- £27 [95% CI - £258 to £204]; p value 0.817). In the secondary analysis, patients treated with sertraline had higher expected net benefits (£122 [95% CI £18 to £226]; p value 0.101) than those in the placebo group. Sertraline had a high probability (> 95%) of being cost-effective if the health system was willing to pay at least £20,000 per QALY gained.
CONCLUSIONS


We found insufficient evidence of a prespecified threshold based on severity or symptom duration that GPs could use to target prescribing to a subgroup of patients where sertraline is most cost-effective. Sertraline is probably a cost-effective treatment for depressive symptoms in UK primary care.
TRIAL REGISTRATION


Controlled Trials ISRCTN Registry, ISRCTN84544741.",2020,There was no evidence of an association between the baseline severity of depressive symptoms and the cost-effectiveness of sertraline.,['Primary Care'],"['Sertraline', 'sertraline with placebo', 'NHS and Personal and Social Services (PSS', 'placebo', 'sertraline versus placebo', 'sertraline', 'PANDA', 'antidepressant sertraline']","['Quality of life data', 'Cost-Effectiveness', 'net benefits', 'longer history of depressive symptoms', 'duration or severity', 'mean costs and mean QALYs and net monetary benefits', 'cost-effectiveness']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C2931429', 'cui_str': 'Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",,0.267615,There was no evidence of an association between the baseline severity of depressive symptoms and the cost-effectiveness of sertraline.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK. william.hollingworth@bristol.ac.uk.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fawsitt', 'Affiliation': 'Health Information and Quality Authority, City Gate, Mahon, Cork, Ireland.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': 'Dixon', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Duffy', 'Affiliation': 'Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, Kings' College London, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Thom', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Nicky J', 'Initials': 'NJ', 'LastName': 'Welton', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PharmacoEconomics - open,['10.1007/s41669-019-00188-5']
473,31397022,The impact of an epilepsy nurse competency framework on the costs of supporting adults with epilepsy and intellectual disability: findings from the EpAID study.,"BACKGROUND


The development of a nurse-led approach to managing epilepsy in adults with an intellectual disability (ID) offers the potential of improved outcomes and lower costs of care. We undertook a cluster randomised trial to assess the impact on costs and outcomes of the provision of ID nurses working to a designated epilepsy nurse competency framework. Here, we report the impact of the intervention on costs.
METHOD


Across the United Kingdom, eight sites randomly allocated to the intervention recruited 184 participants and nine sites allocated to treatment as usual recruited 128 participants. Cost and outcome data were collected mainly by telephone interview at baseline and after 6 months. Total costs at 6 months were compared from the perspective of health and social services and society, with adjustments for pre-specified participant and cluster characteristics at baseline including costs. Missing data were imputed using multiple imputation. Uncertainty was quantified by bootstrapping.
RESULTS


The intervention was associated with lower per participant costs from a health and social services perspective of -£357 (2014/2015 GBP) (95% confidence interval -£986, £294) and from a societal perspective of -£631 (95% confidence interval -£1473, £181). Results were not sensitive to the exclusion of accommodation costs.
CONCLUSIONS


Our findings suggest that the competency framework is unlikely to increase the cost of caring for people with epilepsy and ID and may reduce costs.",2019,"The intervention was associated with lower per participant costs from a health and social services perspective of -£357 (2014/2015 GBP) (95% confidence interval -£986, £294) and from a societal perspective of -£631 (95% confidence interval -£1473, £181).","['184 participants and nine sites allocated to treatment as usual recruited 128 participants', 'Across the United Kingdom', 'adults with epilepsy and intellectual disability', 'adults with an intellectual disability (ID']",['epilepsy nurse competency framework'],"['Total costs', 'costs']","[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}]","[{'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",184.0,0.0835545,"The intervention was associated with lower per participant costs from a health and social services perspective of -£357 (2014/2015 GBP) (95% confidence interval -£986, £294) and from a societal perspective of -£631 (95% confidence interval -£1473, £181).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pennington', 'Affiliation': ""Department of Health Services and Population Research, King's Health Economics, PO24, David Goldberg Centre, Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Ring', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Howlett', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Institute of Public Health, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Redley', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': ""King's Clinical Trials Unit, PO64 Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hook', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Platt', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': ""King's Clinical Trials Unit, PO64 Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pullen', 'Affiliation': 'Epilepsy Action, New Antsey House, Leeds, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mander', 'Affiliation': 'NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, Cambridge, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Donaldson', 'Affiliation': 'Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rowe', 'Affiliation': 'Finance and Contracts, NHS Wakefield Clinical Commissioning Group, Wakefield, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'MRC Biostatistics Unit, University of Cambridge, Institute of Public Health, Cambridge, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Irvine', 'Affiliation': 'School of Nursing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12679']
474,32147070,"The effectiveness of a traditional Persian medicine preparation in the treatment of chronic cough: A randomized, double-blinded, placebo-controlled clinical trial.","OBJECTIVES


The roots and rhizomes of licorice (Glycyrrhiza glabra L.) are used in traditional Persian medicine for the treatment of numerous diseases. A chronic cough is a non-specific reaction to irritation anywhere in the respiratory system. It usually lasts for more than eight weeks. The current study aimed to evaluate the effect of a modified traditional Persian medicine preparation, licorice pastille, in healing a chronic cough.
METHODS


Through a randomized, double-blinded, placebo-controlled clinical trial was performed in a respiratory disease clinic in Shiraz, Iran; between October 2016 and December 2017. Seventy participants with a chronic cough took part in the trial. The outcome measures were as the daily cough scores (the score being logged via patient symptoms, diary, and the visual analogue scale) and the quality of life measure of chronic cough according to the Leicester Cough Questionnaire.
RESULTS


At baseline, there were no significant differences in the demographic or clinical (cough score) characteristics between the two groups. There was complete adherence to protocol in both groups but, the drop-out rate was 4 patients in the placebo and 6 ones in the intervention groups. The results at the end of the trial (Week 2) and follow-up (Week 4) demonstrated the efficacy of the licorice pastille in terms of the cough severity score against the placebo group. This item showed a significant decrease in the intervention group (1.2 ± 0.93) comparing to the placebo one (1.8 ± 1.03) at follow-up time. No major side effects were reported during the study and follow-up time.
CONCLUSIONS


Licorice pastille could be a promising choice in the treatment of a chronic cough of unknown origin.",2020,This item showed a significant decrease in the intervention group (1.2 ± 0.93) comparing to the placebo one (1.8 ± 1.03) at follow-up time.,"['respiratory disease clinic in Shiraz, Iran; between October 2016 and December 2017', 'Seventy participants with a chronic cough took part in the trial', 'chronic cough']","['placebo', 'traditional Persian medicine preparation']","['demographic or clinical (cough score) characteristics', 'cough severity score', 'daily cough scores (the score being logged via patient symptoms, diary, and the visual analogue scale) and the quality of life measure of chronic cough according to the Leicester Cough Questionnaire']","[{'cui': 'C3839239', 'cui_str': 'Respiratory disease clinic'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",70.0,0.174141,This item showed a significant decrease in the intervention group (1.2 ± 0.93) comparing to the placebo one (1.8 ± 1.03) at follow-up time.,"[{'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Ghaemi', 'Affiliation': 'Department of Traditional Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Seyed Masoom', 'Initials': 'SM', 'LastName': 'Masoompour', 'Affiliation': 'Non-Communicable Diseases Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Suleiman', 'Initials': 'S', 'LastName': 'Afsharypuor', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mosaffa-Jahromi', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Pasalar', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: pasalar@sums.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: ahmadi_f@sums.ac.ir.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Niknahad', 'Affiliation': 'Department of Pharmacology and Toxicology, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102324']
475,32147071,Efficacy of a topical formulation of henna (Lawsonia inermis L.) in contact dermatitis in patients using prosthesis: A double-blind randomized placebo-controlled clinical trial.,"BACKGROUND


Contact dermatitis is a common complication in prosthetic limb users. There are no effective, available and cheap treatments for skin problems of these patients. In traditional Iranian medicine, henna (Lawsonia inermis L.) is a plant that has anti-inflammatory, antimicrobial and skin-enhancing properties, all of which are beneficial for people with artificial limbs. The aim of this study was to assess the efficacy of a topical henna preparation in management of contact dermatitis in patients using lower limb prosthetics.
METHODS


The current randomized, double-blind, placebo-controlled clinical trial was conducted on ninety-five participants with lower extremity amputation using limb prosthetics, aged 12-70 years who complained of contact dermatitis. They were randomly assigned to receive either two weeks of topical henna preparation every night as the intervention group, or topical placebo as the control group. Participants were instructed to spread henna preparation on the surfaces of the amputated limb that were in contact with the prosthesis. Severity of contact dermatitis symptoms was set as the primary outcome measure. Edema, papules and erythema were evaluated by a physician using standard color atlas. Secondary outcomes included symptoms such as burning, itching, pain, thickness and skin sweating evaluated by a self-administered questionnaire.
RESULTS


A significant improvement was observed in the symptoms of contact dermatitis including skin edema, itching, sweating, skin thinning and pain (p-value<0.05) in the henna group compared to the placebo group. Skin burning decreased more in the henna group compared to the placebo group, but this was not statistically significant (p-value = 0.052). Moreover, skin redness significantly increased in the henna group (p-value = 0.001).
CONCLUSION


Topical formulation of henna might be a complementary choice for improving contact dermatitis in patients using lower limb prosthetics.",2020,"A significant improvement was observed in the symptoms of contact dermatitis including skin edema, itching, sweating, skin thinning and pain (p-value<0.05) in the henna group compared to the placebo group.","['patients using lower limb prosthetics', 'prosthetic limb users', 'ninety-five participants with lower extremity amputation using limb prosthetics, aged 12-70 years who complained of contact dermatitis', 'contact dermatitis in patients using prosthesis', 'people with artificial limbs']","['topical henna preparation every night as the intervention group, or topical placebo', 'placebo', 'topical formulation of henna (Lawsonia inermis L', 'topical henna preparation']","['skin redness', 'Severity of contact dermatitis symptoms', 'symptoms of contact dermatitis including skin edema, itching, sweating, skin thinning and pain', 'Skin burning', 'symptoms such as burning, itching, pain, thickness and skin sweating evaluated by a self-administered questionnaire', 'Edema, papules and erythema']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011616', 'cui_str': 'Sensitivity, Contact'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0347948', 'cui_str': 'Extremities, Artificial'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1068389', 'cui_str': 'Lawsonia inermis'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011616', 'cui_str': 'Sensitivity, Contact'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521464', 'cui_str': 'Edematous skin (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0332563', 'cui_str': 'Papule (morphologic abnormality)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}]",95.0,0.274781,"A significant improvement was observed in the symptoms of contact dermatitis including skin edema, itching, sweating, skin thinning and pain (p-value<0.05) in the henna group compared to the placebo group.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Niazi', 'Affiliation': 'Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran; Department of Traditional Medicine, Faculty of Traditional Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Mehrabani', 'Affiliation': 'Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Namazi', 'Affiliation': 'Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Salmanpour', 'Affiliation': 'Center for Nanotechnology in Drug Delivery, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Pharmaceutics, Shiraz School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Heydari', 'Affiliation': 'Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrab Mohammad', 'Initials': 'MM', 'LastName': 'Karami', 'Affiliation': 'Department of Orthosis and Prosthesis, Red Crescent Rehabilitation Center, Shiraz, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Parvizi', 'Affiliation': 'Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Fatemi', 'Affiliation': 'Research Center of Tropical and Infectious Diseases, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mehrzad', 'Initials': 'M', 'LastName': 'Mehrbani', 'Affiliation': 'Neuroscience Research Center, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: m.mehrbani@kmu.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102316']
476,32147072,Vascular effects of combined enriched Korean Red ginseng (Panax Ginseng) and American ginseng (Panax Quinquefolius) administration in individuals with hypertension and type 2 diabetes: A randomized controlled trial.,"BACKGROUND


Type 2 diabetes is known to abrogate the vascular response. Combination of two commonly consumed ginseng species, American ginseng (AG) and a Korean Red ginseng (KRG), enriched with ginsensoide Rg3, was shown to concomitantly improve glucemic control and blood pressure. We evaluated the hypothesis that improvements in central hemodynamics, vascular function and stiffness markers are involved in observed benefits of co-administration.
METHODS


In this randomized, placebo controlled, two-center trial, patients with type 2 diabetes and hypertension were assigned to either 2.25 g ginsenoside Rg3-enriched KRG&AG co-administration or a control 3 times daily for 12-weeks, treated by standard of care. The effects on central hemodynamics, pulse wave velocity (PWV) and endothelial function over the 12-week administration were analyzed.
RESULTS


In intent-to-treat analysis of 80 individuals, a reduction in central systolic BP (-4.69 ± 2.24 mmHg, p = 0.04) was observed with co-administration of Rg3-KRG + AG relative to control at 12-weeks, which was characterized by a decrease in end-systolic pressure (-6.60 ± 2.5 mmHg, p = 0.01) and area under the systolic/diastolic BP curve (-132.80 ± 65.1, p = 0.04, 220.90 ± 91.1, p = 0.02, respectively). There was no significant change in reactive hyperemia index (0.09 ± 0.11, p = 0.44), PWV (-0.40 ± 0.28 %, p = 0.17), and other related pulse wave analysis components.
CONCLUSION


Co-administration of complementary ginseng species improved central systolic BP and components of pulse waveform without a direct effect on endothelial function, when added to background pharmacotherapy in individuals with diabetes. These data support potential utility of ginseng for modest blood pressure benefit to broaden its role in diabetes management.",2020,"Co-administration of complementary ginseng species improved central systolic BP and components of pulse waveform without a direct effect on endothelial function, when added to background pharmacotherapy in individuals with diabetes.","['patients with type 2 diabetes and hypertension', 'individuals with diabetes', 'individuals with hypertension and type 2 diabetes']","['placebo', 'ginseng species, American ginseng (AG) and a Korean Red ginseng (KRG', 'combined enriched Korean Red ginseng (Panax Ginseng) and American ginseng (Panax Quinquefolius', 'ginsenoside Rg3-enriched KRG&AG co-administration or a control 3 times daily for 12-weeks, treated by standard of care']","['central systolic BP and components of pulse waveform', 'central systolic BP', 'end-systolic pressure', 'central hemodynamics, vascular function and stiffness markers', 'PWV', 'reactive hyperemia index', 'central hemodynamics, pulse wave velocity (PWV) and endothelial function', 'glucemic control and blood pressure', 'area under the systolic/diastolic BP curve']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0949314', 'cui_str': 'Panax ginseng'}, {'cui': 'C0385181', 'cui_str': 'ginsenoside rg3, (s)-'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1262059', 'cui_str': 'Pulse waveform'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",80.0,0.380135,"Co-administration of complementary ginseng species improved central systolic BP and components of pulse waveform without a direct effect on endothelial function, when added to background pharmacotherapy in individuals with diabetes.","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jovanovski', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Toronto, Canada; Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': 'Lea-Duvnjak-Smircic', 'Affiliation': 'School of Medicine, University of Zagreb, University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Zagreb, Croatia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Komishon', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Toronto, Canada; Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Au-Yeung', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Toronto, Canada; Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Zurbau', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Toronto, Canada; Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Jenkins', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Toronto, Canada.""}, {'ForeName': 'Mi-Kyung', 'Initials': 'MK', 'LastName': 'Sung', 'Affiliation': ""Department of Food and Nutrition, Sookmyung Women's University, Yongsan-gu, Seoul, Republic of Korea.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Josse', 'Affiliation': ""Division of Endocrinology & Metabolism, St. Michael's Hospital, Toronto, Canada; Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vuksan', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Toronto, Canada; Li KaShing Knowledge Institute, St. Michael's Hospital, Toronto, Canada; Division of Endocrinology & Metabolism, St. Michael's Hospital, Toronto, Canada; Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Canada. Electronic address: v.vuksan@utoronto.ca.""}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102338']
477,32147075,Effects of curcuminoids on inflammatory status in patients with non-alcoholic fatty liver disease: A randomized controlled trial.,"BACKGROUND


Nonalcoholic fatty liver diseases (NAFLD) is a highly prevalent disease that is closely associated with several cardiometabolic complications. The potential anti-inflammatory role of curcuminoids that have already been reported to reduce hepatic steatosis, in patients with NAFLD was explored in this study.
METHODS


This double-blind, randomized placebo-controlled trial was conducted for a period of 8 weeks in patients with NAFLD. Subjects (n = 55) were randomly allocated to receive either curcuminoids or placebo. The curcuminoids group received one capsule containing 500 mg curcuminoids (plus 5 mg piperine to increase intestinal absorption) per day for 8 weeks and the control group received matched placebo capsules for the same period. Liver ultrasonography was performed to assess the severity of hepatic steatosis at baseline and the study end. Serum levels of cytokines including interleukin-1α, interleukin-1β, interleukin-2, interleukin-4, interleukin-6, interleukin-8, interleukin-10, tumor necrosis factor-α, monocyte chemoattractant protein-1, interferon γ, vascular endothelial growth factor and epidermal growth factor were measured before and after the intervention.
RESULTS


The two groups were comparable in demographic features at baseline. The results showed that supplementation with curcuminoids could decrease weight compared to the placebo group (p = 0.016) in patients with NAFLD. Curcuminoids supplementation improved the severity of NAFLD according to the ultrasound results (p = 0.002). Moreover, serum concentrations of TNF-α (p = 0.024), MCP-1 (p = 0.008) and EGF (p = 0.0001) were improved by curcuminoids in NAFLD patients.
CONCLUSIONS


The results of our study showed that curcumin supplementation can improve serum levels of inflammatory cytokines in subjects with NAFLD and this might be at least partly responsible for the anti-steatotic effects of curcuminoids.",2020,The results showed that supplementation with curcuminoids could decrease weight compared to the placebo group (p = 0.016) in patients with NAFLD.,"['patients with non-alcoholic fatty liver disease', 'subjects with NAFLD', 'Subjects (n\u202f=\u202f55', 'patients with NAFLD']","['curcumin supplementation', 'Liver ultrasonography', 'placebo capsules', 'curcuminoids or placebo', 'placebo', 'curcuminoids']","['Serum levels of cytokines including interleukin-1α, interleukin-1β, interleukin-2, interleukin-4, interleukin-6, interleukin-8, interleukin-10, tumor necrosis factor-α, monocyte chemoattractant protein-1, interferon γ, vascular endothelial growth factor and epidermal growth factor', 'serum levels of inflammatory cytokines', 'weight', 'inflammatory status', 'serum concentrations of TNF-α', 'severity of NAFLD', 'MCP-1', 'severity of hepatic steatosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}]",55.0,0.469692,The results showed that supplementation with curcuminoids could decrease weight compared to the placebo group (p = 0.016) in patients with NAFLD.,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saberi-Karimian', 'Affiliation': 'Student Research Committee, Iranian UNESCO Center of Excellence for Human Nutrition, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Keshvari', 'Affiliation': 'Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghayour-Mobarhan', 'Affiliation': 'Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Cardiovascular Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Salehizadeh', 'Affiliation': 'Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Rahmani', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Behnam', 'Affiliation': 'Pharmaceutics Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran; Herbal and Traditional Medicines Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Jamialahmadi', 'Affiliation': 'Halal Research Center of IRI, FDA, Tehran, Iran; Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Asgary', 'Affiliation': 'Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: sedighehasgary@gmail.com.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran; School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: amir_saheb2000@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102322']
478,32147046,"A randomized controlled study of dose-finding, efficacy, and safety of mulberry leaves on glycemic profiles in obese persons with borderline diabetes.","OBJECTIVES


Mulberry (Morus alba L.) leaves have been used in traditional medicine for treating hyperglycemia. However, there remains difficulties in the implementation of mulberry leaves in evidence-based practice. The aims of this study were to examine the optimal dose of 1-deoxynojirimycin (DNJ) in mulberry leaves and to determine the efficacy and safety of mulberry leaves in glycemic control in obese persons with borderline diabetes.
DESIGN


First, healthy adults were recruited into the dose-finding study and randomly allocated to ingest sucrose solution concurrently with mulberry leaf powder at weights equivalent to 0 (control), 6, 12, and 18 mg of DNJ. Postprandial glucose and undesirable effects were evaluated. Second, obese persons with borderline diabetes were randomly assigned into the mulberry-leaves treatment group (12 mg of mulberry DNJ three times daily) and the control group in the 12-week prospective study. Blood glucose and insulin as well as adverse effects were determined.
RESULTS


Twelve mg of mulberry DNJ was the minimum effective dose attenuating postprandial hyperglycemia. Mulberry leaves decreased fasting plasma glucose (FPG) by 3.86 ± 5.99 mg/dL (p = 0.002) and glycated hemoglobin (HbA1c) by 0.11 ± 0.22 % (p = 0.011) when compared with the baseline levels. Improvement in glucose tolerance was not observed. Furthermore, mulberry leaves tended to ameliorate insulin resistance (p = 0.057). Adverse events of mulberry leaves commonly found in this study were gastrointestinal symptoms including bloating, flatulence, and loose stools.
CONCLUSION


Mulberry leaves possessed favorable effects on glycemic profiles without serious side effects.",2020,Mulberry leaves decreased fasting plasma glucose (FPG) by 3.86 ± 5.99 mg/dL (p = 0.002) and glycated hemoglobin (HbA1c) by 0.11 ± 0.22 % (p = 0.011) when compared with the baseline levels.,"['obese persons with borderline diabetes', 'healthy adults']","['1-deoxynojirimycin (DNJ', 'mulberry leaves', 'ingest sucrose solution concurrently with mulberry leaf powder at weights equivalent to 0', 'mulberry', 'DNJ', 'mulberry-leaves treatment group (12 mg of mulberry DNJ']","['fasting plasma glucose (FPG', 'glycemic profiles', 'glucose tolerance', 'Blood glucose and insulin as well as adverse effects', 'Postprandial glucose and undesirable effects', 'insulin resistance', 'glycated hemoglobin (HbA1c', 'bloating, flatulence, and loose stools', 'postprandial hyperglycemia']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0089267', 'cui_str': '3,4,5-Piperidinetriol, 2-(hydroxymethyl)-, (2R-(2alpha,3beta,4alpha,5beta))-'}, {'cui': 'C0330540', 'cui_str': 'Mulberry'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0242724', 'cui_str': 'Plant Leaves'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C2129214', 'cui_str': 'Loose stool (finding)'}, {'cui': 'C1855520', 'cui_str': 'Hyperglycemia, Postprandial'}]",,0.019725,Mulberry leaves decreased fasting plasma glucose (FPG) by 3.86 ± 5.99 mg/dL (p = 0.002) and glycated hemoglobin (HbA1c) by 0.11 ± 0.22 % (p = 0.011) when compared with the baseline levels.,"[{'ForeName': 'Thanchanit', 'Initials': 'T', 'LastName': 'Thaipitakwong', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand; Bioactive Resources for Innovative Clinical Applications Research Unit, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ouppatham', 'Initials': 'O', 'LastName': 'Supasyndh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok, Thailand.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Rasmi', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine and Cellular and Molecular Research Center, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Pornanong', 'Initials': 'P', 'LastName': 'Aramwit', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand; Bioactive Resources for Innovative Clinical Applications Research Unit, Chulalongkorn University, Bangkok, Thailand. Electronic address: Pornanong.A@pharm.chula.ac.th.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2019.102292']
479,32147053,Evaluation of the efficacy of warm salt water foot-bath on patients with painful diabetic peripheral neuropathy: A randomized clinical trial.,"OBJECTIVES


Pain relief is one of the main goals of treatment in Diabetic peripheral neuropathy (DPN). Abzan(foot- bath) is one of the effective ways to relief various types of pain in Persian Medicine (PM).
DESIGN


This study is a randomized clinical trial (RCT) conducted on 60 patients of age range within 30 to 70 years, which were randomly divided into three groups. Group A (warm water bath):For one month each night before bedtime, they were asked to sit on a chair with trousers pulled up to about 5 cm above the ankles and both feet immersed in an electrical foot-bath that contained 5 liters of warm tolerable water (between 40 and 45 ° C) for 15 minutes without any massage. In Group B (salt water bath) was added and dissolved 250 grams of powdered mineral salt to their warm water. Other stages were similar to the group A. Group C (control) did not receive any interventions. Patients were evaluated prior to and following the intervention by the Douleur Neuropathique 4 questionnaire (DN4), The McGill Pain questionnaire and The World Health Organization Bref Quality of Life (WHOQOL-BREF) questionnaire.
RESULTS


Decrease in DN4 score level in the salt warm water group was significant while The McGill questionnaire showed a significant decrease of pain level the same group.
CONCLUSIONS


Application of a specific Abzan (salt water bath) may significantly decrease the pain of DPN patients.",2020,"RESULTS


Decrease in DN4 score level in the salt warm water group was significant while The McGill questionnaire showed a significant decrease of pain level the same group.
","['60 patients of age range within 30 to 70 years', 'Diabetic peripheral neuropathy (DPN', 'patients with painful diabetic peripheral neuropathy']","['warm salt water foot-bath', 'Abzan(foot- bath', 'specific Abzan (salt water bath']","['pain', 'DN4 score level', 'pain level', 'Douleur Neuropathique 4 questionnaire (DN4), The McGill Pain questionnaire and The World Health Organization Bref Quality of Life (WHOQOL-BREF) questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0337055', 'cui_str': 'Salt water (substance)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0150141'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0034380'}]",,0.0262018,"RESULTS


Decrease in DN4 score level in the salt warm water group was significant while The McGill questionnaire showed a significant decrease of pain level the same group.
","[{'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Vakilinia', 'Affiliation': 'Student Research Committee, Department of Iranian Traditional Medicine, School of Medicine, Qom University of Medical Sciences, Qom, Iran. Electronic address: vakilireza45@gmail.com.'}, {'ForeName': 'Mahdi Alizadeh', 'Initials': 'MA', 'LastName': 'Vaghasloo', 'Affiliation': 'Department of Traditional Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: m-alizadehv@sina.tums.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Aliasl', 'Affiliation': 'School of Medicine, Qom University of Medical Sciences, Qom, Iran. Electronic address: aliasl1392@gmail.com.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Mohammadbeigi', 'Affiliation': 'Neuroscience Research Center, Faculty of Health, Qom University of Medical Sciences, Qom, Iran. Electronic address: Beigi60@gmail.com.'}, {'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Bitarafan', 'Affiliation': 'School of Medicine, Qom University of Medical Sciences, Qom, Iran. Electronic address: bitarafanbita@yahoo.com.'}, {'ForeName': 'Genan', 'Initials': 'G', 'LastName': 'Etripoor', 'Affiliation': 'Kamkar Hospital, Qom University of Medical Sciences, Qom, Iran. Electronic address: jatripoor@gmail.com.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Asghari', 'Affiliation': 'Department of Iranian Traditional Medicine, School of Medicine, Qom University of Medical Sciences, Qom, Iran. Electronic address: Asghari@muq.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102325']
480,32147068,The effectiveness of familiar olfactory stimulation with lavender scent and glucose on the pain of blood sampling in term neonates: A randomized controlled clinical trial.,"OBJECTIVE


Neonates are exposed to multiple painful invasive procedures. Pain management in neonates is an ethical and important task for nurses. This study aimed to evaluate the effectiveness of familiar olfactory stimulation with lavender scent and glucose on the pain of blood sampling in term neonates.
DESIGN


A randomized, single blind clinical trial.
SETTING


Hashemi Nezhad Hospital (Mashhad, Iran).
INTERVENTION


Before and during blood sampling, one group was exposed to the scent of lavender (n = 40), the second group received 2 ml of edible glucose 30 % (n = 40), two minutes before the blood sampling, and the third group received no specific intervention (n = 40).
MAIN OUTCOME MEASURES


Simultaneously with needle insertion, the Douleur Aigue du Nouveau-ne (DAN) scale was used to calculate the pain score. The duration of crying (in seconds) was measured from start to end (silence).
RESULTS


The study participants' mean age was 5.49 ± 2.13 days; 60 % of them were girls, and 65.8 % had the gestational age of 38-39 weeks. The mean pain scores were 4.47 ± 1.81, 4.80 ± 1.92, and 5.97 ± 1.94 in the aromatherapy group, the glucose group, and the control group respectively (p < 0.001). No significant difference was recorded between the groups regarding the crying time (P = 0.12).
CONCLUSIONS


Our findings suggest that use of aromatherapy with lavender and edible glucose as easy and applicable nursing care can reduce the pain of blood sampling in term neonates and can be considered as effective interventions in neonate pain management, although more research is recommended.",2020,"The mean pain scores were 4.47 ± 1.81, 4.80 ± 1.92, and 5.97 ± 1.94 in the aromatherapy group, the glucose group, and the control group respectively (p < 0.001).","['term neonates', ""The study participants' mean age was 5.49 ± 2.13 days; 60 % of them were girls, and 65.8 % had the gestational age of 38-39 weeks"", 'Hashemi Nezhad Hospital (Mashhad, Iran']","['aromatherapy with lavender and edible glucose', 'no specific intervention', '2 ml of edible glucose', 'lavender scent and glucose']","['mean pain scores', 'duration of crying', 'Douleur Aigue du Nouveau-ne (DAN) scale', 'Pain management', 'pain score', 'pain of blood sampling', 'crying time']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0376547', 'cui_str': 'Therapy, Aroma'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2987717', 'cui_str': 'Aroma'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.044102,"The mean pain scores were 4.47 ± 1.81, 4.80 ± 1.92, and 5.97 ± 1.94 in the aromatherapy group, the glucose group, and the control group respectively (p < 0.001).","[{'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Razaghi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyedeh Zahra', 'Initials': 'SZ', 'LastName': 'Aemmi', 'Affiliation': 'Department of Nursing, Nursing and Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: aammiz1@mums.ac.ir.'}, {'ForeName': 'Akram Sadat', 'Initials': 'AS', 'LastName': 'Sadat Hoseini', 'Affiliation': 'Department of Pediatric Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Boskabadi', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Mohebbi', 'Affiliation': 'Hashemi Nezhad Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Monir', 'Initials': 'M', 'LastName': 'Ramezani', 'Affiliation': 'Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2019.102289']
481,32147069,Feasibility of implementing a virtual reality program as an adjuvant tool for peri-operative pain control; Results of a randomized controlled trial in minimally invasive foregut surgery.,"BACKGROUND


Post-operative pain control and narcotic over-utilization are challenging issues for surgeons in all fields. While virtual reality (VR) has been increasingly applied in various fields, its feasibility and efficacy in the peri-operative period has not been evaluated. The aim of this study was to examine the experience of an integrated VR protocol in the perioperative setting.
METHODS


Patients undergoing minimally invasive foregut surgery at a single institution were randomized to receive a series of VR meditation/mindfulness sessions (VR) or to standard care after surgery (non-VR). Post-operative pain levels, narcotic utilization and patient satisfaction were tracked.
RESULTS


Fifty-two patients were enrolled with 26 in each arm. Post-operative pain scores, total narcotic utilization, and overall satisfaction scores were not significantly different between the two groups. For patients in the VR arm, sessions were able to be incorporated into the perioperative routine with little disruption. Most (73.9 %) were able complete all six VR sessions and reported low pain, anxiety, and nausea scores while using the device. A high proportion responded that they would use VR again (76.2 %) or would like a VR program designed for pain (62.0 %). There were no complications from device usage.
CONCLUSION


VR is a safe and simple intervention that is associated with high patient satisfaction and is feasible to implement in the perioperative setting. While the current study is underpowered to detect difference in narcotic utilization, this device holds promise as an adjuvant tool in multimodal pain and anxiety control in the peri-operative period.",2020,"Post-operative pain scores, total narcotic utilization, and overall satisfaction scores were not significantly different between the two groups.","['Patients undergoing minimally invasive foregut surgery at a single institution', 'minimally invasive foregut surgery', 'peri-operative pain control', 'Fifty-two patients were enrolled with 26 in each arm']","['VR meditation/mindfulness sessions (VR) or to standard care after surgery (non-VR', 'virtual reality program', 'While virtual reality (VR']","['Post-operative pain scores, total narcotic utilization, and overall satisfaction scores', 'Post-operative pain levels, narcotic utilization and patient satisfaction', 'low pain, anxiety, and nausea scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0231051', 'cui_str': 'Primitive foregut structure'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0150277'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",52.0,0.034895,"Post-operative pain scores, total narcotic utilization, and overall satisfaction scores were not significantly different between the two groups.","[{'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Haisley', 'Affiliation': 'Center for Minimally Invasive Surgery, The Ohio State University Wexner Medical Center, Columbus, OH, United States; Foundation for Surgical Innovation and Education, Portland, OR, United States; Division of Gastrointestinal and Minimally Invasive Surgery, The Oregon Clinic, Portland, OR, United States.'}, {'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Straw', 'Affiliation': 'Foundation for Surgical Innovation and Education, Portland, OR, United States.'}, {'ForeName': 'Dolores T', 'Initials': 'DT', 'LastName': 'Müller', 'Affiliation': 'Foundation for Surgical Innovation and Education, Portland, OR, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Antiporda', 'Affiliation': 'Foundation for Surgical Innovation and Education, Portland, OR, United States; GI Surgical Specialists, Fort Meyers, FL, United States.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Zihni', 'Affiliation': 'Foundation for Surgical Innovation and Education, Portland, OR, United States; Denver Esopahgeal and Stomach Center, Denver, CO, United States.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Reavis', 'Affiliation': 'Foundation for Surgical Innovation and Education, Portland, OR, United States; Division of Gastrointestinal and Minimally Invasive Surgery, The Oregon Clinic, Portland, OR, United States.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Bradley', 'Affiliation': 'Foundation for Surgical Innovation and Education, Portland, OR, United States; Division of Gastrointestinal and Minimally Invasive Surgery, The Oregon Clinic, Portland, OR, United States.'}, {'ForeName': 'Christy M', 'Initials': 'CM', 'LastName': 'Dunst', 'Affiliation': 'Foundation for Surgical Innovation and Education, Portland, OR, United States; Division of Gastrointestinal and Minimally Invasive Surgery, The Oregon Clinic, Portland, OR, United States. Electronic address: cdunst@orclinic.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102356']
482,32147076,"Effect of green coffee extract supplementation on serum adiponectin concentration and lipid profile in patients with non-alcoholic fatty liver disease: A randomized, controlled trial.","OBJECTIVES


The current study evaluated the effects of green coffee extract (GCE) on serum lipid profile and adiponectin levels in patients with nonalcoholic fatty liver disease (NAFLD).
DESIGN


This randomized, double-blind, placebo-controlled clinical trial was conducted on NAFLD patients aged 20-60 years and body mass index (BMI) of 25-35 kg/m 2 .
SETTING


Patients were recruited from the Bahman poly-clinic (Neyshabur, Iran) between January and June 2016.
INTERVENTIONS


The study subjects were randomly assigned to receive a daily dose of 400 mg GCE (n = 24) or placebo (n = 24) for eight weeks.
MAIN OUTCOME MEASURES


Serum liver enzyme levels, lipid profile, adiponectin concentrations, and hepatic steatosis grade were measured for all patients at baseline and the end of the trial.
RESULTS


GCE supplementation significantly reduced BMI [mean difference (MD): -0.57 and 95 % confidence interval (CI): -0.84 to -0.29, P < 0.001] and increased serum high-density lipoprotein cholesterol (MD: 7.06, 95 % CI: 0.25-13.87, P < 0.05) compared to the control group. Serum total cholesterol decreased significantly within the GCE group (MD: -13.33, 95 % CI: -26.04 to -0.61, P < 0.05). Triglyceride levels reduced significantly in GCE group compared to the placebo group (MD: -37.91; 95 % CI: -72.03 to -3.80; P = 0.03). However, this reduction was not significant when was further adjusted for mean changes in BMI and daily energy intake (MD: -23.43; 95 % CI: -70.92 to 24.06; P = 0.32). Hepatic steatosis grade, liver enzymes, and adiponectin levels did not show significant differences between the two groups after the intervention.
CONCLUSIONS


GCE supplementation improved serum lipid profile and BMI in individuals with NAFLD. GCE may be useful in controlling NAFLD risk factors.",2020,"RESULTS


GCE supplementation significantly reduced BMI [mean difference (MD): -0.57 and 95 % confidence interval (CI):","['Patients were recruited from the Bahman poly-clinic (Neyshabur, Iran) between January and June 2016', 'individuals with NAFLD', 'patients with non-alcoholic fatty liver disease', 'NAFLD patients aged 20-60 years and body mass index (BMI) of 25-35\u202fkg/m 2 ', 'patients with nonalcoholic fatty liver disease (NAFLD']","['green coffee extract supplementation', 'green coffee extract (GCE', 'placebo', 'GCE supplementation', 'GCE']","['BMI and daily energy intake (MD', 'serum lipid profile and adiponectin levels', 'serum high-density lipoprotein cholesterol (MD', 'Hepatic steatosis grade, liver enzymes, and adiponectin levels', 'Triglyceride levels', 'serum lipid profile and BMI', 'BMI', 'Serum liver enzyme levels, lipid profile, adiponectin concentrations, and hepatic steatosis grade', 'Serum total cholesterol', 'serum adiponectin concentration and lipid profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C1287351', 'cui_str': 'Finding of liver enzyme levels (finding)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",,0.595235,"RESULTS


GCE supplementation significantly reduced BMI [mean difference (MD): -0.57 and 95 % confidence interval (CI):","[{'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Hosseinabadi', 'Affiliation': ""Students' Research Committee, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Rafraf', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: rafrafm@tbzmed.ac.ir.'}, {'ForeName': 'Somayyeh', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': 'Nutrition Research Center, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asghari-Jafarabadi', 'Affiliation': 'Department of Statistics and Epidemiology, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, Iran; Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Vojouhi', 'Affiliation': 'Internists, 22 Bahman Hospital, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2019.102290']
483,32147077,"Curcumin ameliorates health-related quality of life in patients with liver cirrhosis: A randomized, double-blind placebo-controlled trial.","OBJECTIVES


Current study aimed to find the effects of curcumin on quality of life (QoL) in liver cirrhotic patients.
DESIGN


In this randomized double-masked placebo-controlled trial, 70 cases with liver cirrhosis aged 20-70 years were randomly divided into two groups to receive 1000 mg/day curcumin (n = 35) or placebo (n = 35) for 12 weeks. The health-related QoL (HRQoL) was assessed by CLDQ, LDSI 2.0, and SF-36.
RESULTS


Fifty-eight patients (28 in curcumin and 30 in placebo groups) finished the research. Compared with baseline, overall scores as well as most of CLDQ domains (e.g. Fatigue, Emotional Function, Worry, Abdominal Symptoms, and Systemic Symptoms) and the Physical and Mental health (Total) scores and most of SF-36 domains (e.g. Physical Functioning, Bodily Pain, Vitality, Social Functioning, and Mental Health) increased considerably (P < 0.05) after curcumin administration. Furthermore, curcumin reduced most of LDSI 2.0 domains (e.g. Itch, Joint pain, Pain in the right upper abdomen, Sleeping during the day, Decreased appetite, Depression, Fear of complication, Jaundice, Hindrance in Financial Affairs, Change in use of time, Decreased sexual interest, and Decreased sexual activity) significantly (P < 0.05). Significant differences were noticed between two groups in CLDQ domains and overall scores, LDSI 2.0 domains and overall scores, SF-36 Physical and Mental health (total) scores and all its domains scores (P < 0.05), adjusting for baseline values and disease duration.
CONCLUSIONS


Curcumin improved QoL in liver cirrhotic patients according to CLDQ, LDSI 2.0, and SF-36 domains. Additional studies are warranted to consider curcumin as a safe, accessible, and low-cost complementary therapeutic option in cirrhosis.",2020,"Significant differences were noticed between two groups in CLDQ domains and overall scores, LDSI 2.0 domains and overall scores, SF-36 Physical and Mental health (total) scores and all its domains scores (P < 0.05), adjusting for baseline values and disease duration.
","['70 cases with liver cirrhosis aged 20-70 years', 'liver cirrhotic patients', 'patients with liver cirrhosis']","['curcumin', 'placebo', '1000\u202fmg/day curcumin']","['CLDQ domains and overall scores, LDSI 2.0 domains and overall scores, SF-36 Physical and Mental health (total) scores', 'Curcumin ameliorates health-related quality of life', 'LDSI 2.0 domains (e.g. Itch, Joint pain, Pain in the right upper abdomen, Sleeping during the day, Decreased appetite, Depression, Fear of complication, Jaundice, Hindrance in Financial Affairs, Change in use of time, Decreased sexual interest, and Decreased sexual activity', 'health-related QoL (HRQoL', 'quality of life (QoL', 'CLDQ domains (e.g. Fatigue, Emotional Function, Worry, Abdominal Symptoms, and Systemic Symptoms) and the Physical and Mental health (Total) scores and most of SF-36 domains (e.g. Physical Functioning, Bodily Pain, Vitality, Social Functioning, and Mental Health']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0230165', 'cui_str': 'Upper abdomen (surface region)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0022346', 'cui_str': 'Icterus'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0424400', 'cui_str': 'Erotic interest (observable entity)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",70.0,0.406915,"Significant differences were noticed between two groups in CLDQ domains and overall scores, LDSI 2.0 domains and overall scores, SF-36 Physical and Mental health (total) scores and all its domains scores (P < 0.05), adjusting for baseline values and disease duration.
","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Nouri-Vaskeh', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Afshan', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Malek Mahdavi', 'Affiliation': 'Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: aidamalek@gmail.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Alizadeh', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: alizadele@gmail.com.'}, {'ForeName': 'Xiude', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ""Department of Infectious Diseases, The First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an, 710061 China; Department of Inflammation and Immunity, Cleveland Clinic, Cleveland, 44195, USA.""}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Zarei', 'Affiliation': ""Departrment of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA; Center for Mitochondrial and Epigenomic Medicine, Children's Hospital of Philadelphia, Philadelphia, USA.""}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102351']
484,32147078,The effect of vitamin E supplementation on biomarkers of endothelial function and inflammation among hemodialysis patients: A double-blinded randomized clinical trial.,"OBJECTIVES


The present study was aimed to investigate the effect of alpha-tocopherol supplementation on biomarkers of endothelial function (Intercellular Adhesion Molecule 1 and Vascular Cell Adhesion Protein 1) and inflammatory markers (Interleukin 6 and high-sensitivity C-reactive protein) among the hemodialysis patients.
METHODS


To conduct this randomized, double-blinded, and placebo-controlled clinical trial, 49 hemodialysis patients, aged 20-60 years, were recruited and randomly divided into the intervention and control groups. The intervention group (n = 25) received 600 IU alpha-tocopherol soft gels (200 IU three times daily), while the controls (n = 24) consumed the identical placebo soft gels for 10 weeks. At the baseline and end of the study, 7 ml pre-dialysis blood samples were taken from all participants to measure their serum concentrations of ICAM-1, VCAM-1, IL-6, and hs-CRP.
RESULTS


Alpha-tocopherol supplementation reduced the serum levels of ICAM-1 and VCAM-1 significantly (-140.67 ± 57.25 ng/ml vs. -15.97 ± 79.19 ng/ml, P = 0.001 for ICAM-1 and --6.79 ± 4.76 ng/ml vs. 1.02 ± 3.22 ng/ml, P = 0.019 for VCAM-1). However, no significant difference was observed between the two groups regarding the serum levels of hs-CRP (-0.15 ± 0.19 mg/l vs. 0.02 ± 0.12 mg/l; P = 0.32) and IL-6 (-0.03 ± 0.1 pg/ml vs. - 0.06 ± 0.11 pg/ml; P = 0.65).
CONCLUSIONS


Our results showed that 10 weeks of supplementation with 600 IU alpha-tocopherol improved ICAM-1 and VCAM-1 levels, but did not have any effect on the serum concentration of IL-6 and hs-CRP in hemodialysis patients. Further studies are required to confirm these findings.",2020,"RESULTS


Alpha-tocopherol supplementation reduced the serum levels of ICAM-1 and VCAM-1 significantly","['49 hemodialysis patients, aged 20-60 years', 'hemodialysis patients']","['alpha-tocopherol supplementation', 'vitamin E supplementation', 'placebo', '600 IU alpha-tocopherol soft gels']","['IL-6', 'serum levels of hs-CRP', 'endothelial function (Intercellular Adhesion Molecule 1 and Vascular Cell Adhesion Protein 1) and inflammatory markers (Interleukin 6 and high-sensitivity C-reactive protein', 'serum concentration of IL-6 and hs-CRP', 'endothelial function and inflammation', 'serum levels of ICAM-1 and VCAM-1', 'ICAM-1 and VCAM-1 levels', 'serum concentrations of ICAM-1, VCAM-1, IL-6, and hs-CRP']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0969677', 'cui_str': 'd-alpha tocopherol'}, {'cui': 'C4524012', 'cui_str': 'Vitamin E supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}]",49.0,0.525699,"RESULTS


Alpha-tocopherol supplementation reduced the serum levels of ICAM-1 and VCAM-1 significantly","[{'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Pirhadi-Tavandashti', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Imani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: h-imani@sina.tums.ac.ir.'}, {'ForeName': 'Soraiya', 'Initials': 'S', 'LastName': 'Ebrahimpour-Koujan', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Samavat', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Monir Sadat', 'Initials': 'MS', 'LastName': 'Hakemi', 'Affiliation': 'Department of Nephrology, Dr. Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102357']
485,31693081,Association of Autofluorescence-Based Detection of the Parathyroid Glands During Total Thyroidectomy With Postoperative Hypocalcemia Risk: Results of the PARAFLUO Multicenter Randomized Clinical Trial.,"Importance


Because inadvertent damage of parathyroid glands can lead to postoperative hypocalcemia, their identification and preservation, which can be challenging, are pivotal during total thyroidectomy.
Objective


To determine if intraoperative imaging systems using near-infrared autofluorescence (NIRAF) light to identify parathyroid glands could improve parathyroid preservation and reduce postoperative hypocalcemia.
Design, Setting, and Participants


This randomized clinical trial was conducted from September 2016 to October 2018, with a 6-month follow-up at 3 referral hospitals in France. Adult patients who met eligibility criteria and underwent total thyroidectomy were randomized. The exclusion criteria were preexisting parathyroid diseases.
Interventions


Use of intraoperative NIRAF imaging system during total thyroidectomy.
Main Outcomes and Measures


The primary outcome was the rate of postoperative hypocalcemia (a corrected calcium <8.0 mg/dL [to convert to mmol/L, multiply by 0.25] at postoperative day 1 or 2). The main secondary outcomes were the rates of parathyroid gland autotransplantation and inadvertent parathyroid gland resection.
Results


A total of 245 of 529 eligible patients underwent randomization. Overall, 241 patients were analyzed for the primary outcome (mean [SD] age, 53.6 [13.6] years; 191 women [79.3%]): 121 who underwent NIRAF-assisted thyroidectomy and 120 who underwent conventional thyroidectomy (control group). The temporary postoperative hypocalcemia rate was 9.1% (11 of 121 patients) in the NIRAF group and 21.7% (26 of 120 patients) in the control group (between-group difference, 12.6% [95% CI, 5.0%-20.1%]; P = .007). There was no significant difference in permanent hypocalcemia rates (0% in the NIRAF group and 1.6% [2 of 120 patients] in the control group). Multivariate analyses accounting for center and surgeon heterogeneity and adjusting for confounders, found that use of NIRAF reduced the risk of hypocalcemia with an odds ratio of 0.35 (95% CI, 0.15-0.83; P = .02). Analysis of secondary outcomes showed that fewer patients experienced parathyroid autotransplantation in the NIRAF group than in the control group: respectively, 4 patients (3.3% [95% CI, 0.1%-6.6%) vs 16 patients (13.3% [95% CI, 7.3%-19.4%]; P = .009). The number of inadvertently resected parathyroid glands was significantly lower in the NIRAF group than in the control group: 3 patients (2.5% [95% CI, 0.0%-5.2%]) vs 14 patients (11.7% [95% CI, 5.9%-17.4%], respectively; P = .006).
Conclusions and Relevance


The use of NIRAF for the identification of the parathyroid glands may help improve the early postoperative hypocalcemia rate significantly and increase parathyroid preservation after total thyroidectomy.
Trial Registration


ClinicalTrials.gov Identifier: NCT02892253.",2020,"The number of inadvertently resected parathyroid glands was significantly lower in the NIRAF group than in the control group: 3 patients (2.5% [95% CI, 0.0%-5.2%]) vs 14 patients (11.7% [95% CI, 5.9%-17.4%], respectively; P = .006).
","['241 patients were analyzed for the primary outcome (mean [SD] age, 53.6 [13.6] years; 191 women [79.3%]): 121 who underwent NIRAF-assisted thyroidectomy and 120 who underwent conventional thyroidectomy (control group', 'A total of 245 of 529 eligible patients underwent randomization', 'September 2016 to October 2018, with a 6-month follow-up at 3 referral hospitals in France', 'During Total Thyroidectomy With Postoperative Hypocalcemia Risk', 'Adult patients who met eligibility criteria and underwent total thyroidectomy were randomized']","['intraoperative NIRAF imaging system', 'Parathyroid Glands', 'NIRAF']","['permanent hypocalcemia rates', 'number of inadvertently resected parathyroid glands', 'rate of postoperative hypocalcemia', 'temporary postoperative hypocalcemia rate', 'parathyroid autotransplantation', 'rates of parathyroid gland autotransplantation and inadvertent parathyroid gland resection', 'risk of hypocalcemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C4517806', 'cui_str': '529 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",529.0,0.20402,"The number of inadvertently resected parathyroid glands was significantly lower in the NIRAF group than in the control group: 3 patients (2.5% [95% CI, 0.0%-5.2%]) vs 14 patients (11.7% [95% CI, 5.9%-17.4%], respectively; P = .006).
","[{'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Benmiloud', 'Affiliation': 'Endocrine Surgery Unit, Hôpital Européen Marseille, Marseille, France.'}, {'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Godiris-Petit', 'Affiliation': 'General and Endocrine Surgery Unit, Groupement Hospitalier Universitaire Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Gras', 'Affiliation': 'Head and Neck Surgery Unit, Hôpital Saint-Joseph, Marseille, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Gillot', 'Affiliation': 'Head and Neck Surgery Unit, Hôpital Saint-Joseph, Marseille, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Turrin', 'Affiliation': 'General and Endocrine Surgery Unit, Hôpital Saint-Joseph, Marseille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Penaranda', 'Affiliation': 'Biostatistic, Alphabio, Marseille, France.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Noullet', 'Affiliation': 'General and Endocrine Surgery Unit, Groupement Hospitalier Universitaire Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Chéreau', 'Affiliation': 'General and Endocrine Surgery Unit, Groupement Hospitalier Universitaire Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gaudart', 'Affiliation': ""Aix Marseille Université, Assistance Publique-Hôpitaux de Marseille, Institut National de la Santé et de la Recherche Médicale, L'Institut de Recherche Pour le Développement, Sciences Économiques et Sociales de la Santé et Traitement de L'information Médicale, Hôpital Timone, BioSTIC, Biostatistics & Information and Communication Technology, Marseille, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Chiche', 'Affiliation': 'Internal Medicine Unit, Hôpital Européen Marseille, Marseille, France.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Rebaudet', 'Affiliation': 'Internal Medicine Unit, Hôpital Européen Marseille, Marseille, France.'}]",JAMA surgery,['10.1001/jamasurg.2019.4613']
486,31654784,Optimizing Whole Brain Radiation Therapy Dose and Fractionation: Results From a Prospective Phase 3 Trial (NCCTG N107C [Alliance]/CEC.3).,"PURPOSE


Whole brain radiation therapy (WBRT) remains a commonly used cancer treatment, although controversy exists regarding the optimal dose/fractionation to optimize intracranial tumor control and minimize resultant cognitive deficits.
METHODS AND MATERIALS


NCCTG N107C [Alliance]/CEC.3 randomized 194 patients with brain metastases to either stereotactic radiosurgery alone or WBRT after surgical resection. Among the 92 patients receiving WBRT, sites predetermined the dose/fractionation that would be used for all patients treated at that site (either 30 Gy in 10 fractions or 37.5 Gy in 15 fractions). Analyses were performed using Kaplan-Meier estimates, log rank tests, and Fisher's exact tests.
RESULTS


Among 92 patients treated with surgical resection and adjuvant WBRT, 49 were treated with 30 Gy in 10 fractions (53%), and 43 were treated with 37.5 Gy in 15 fractions (47%). Baseline characteristics, including cognitive testing, were well balanced between groups with the exception of primary tumor type (lung cancer histology was more frequent with protracted WBRT: 72% vs 45%, P = .01), and 93% of patients completed the full course of WBRT. A more protracted WBRT dose regimen (37.5 Gy in 15 fractions) did not significantly affect time to cognitive failure (hazard ratio [HR], 0.9; 95% confidence interval [CI], 0.6-1.39; P = .66), surgical bed control (HR, 0.52 [95% CI, 0.22-1.25], P = .14), intracranial tumor control (HR, 0.56 [95% CI, 0.28-1.12], P = .09), or overall survival (HR, 0.72 [95% CI, 0.45-1.16], P = .18). Although there was no reported radionecrosis, there is a statistically significant increase in the risk of at least 1 grade ≥3 adverse event with 37.5 Gy in 15 fractions versus 30 Gy in 10 fractions (54% vs 31%, respectively, P = .03).
CONCLUSIONS


This post hoc analysis does not demonstrate that protracted WBRT courses reduce the risk of cognitive deficit, improve tumor control in the hypoxic surgical cavity, or otherwise improve the therapeutic ratio. Adverse events were significantly higher with the lengthened course of WBRT. For patients with brain metastases where WBRT is recommended, shorter course hypofractionated regimens remain the current standard of care.",2020,"This post hoc analysis does not demonstrate that protracted WBRT courses reduce the risk of cognitive deficit, improve tumor control in the hypoxic surgical cavity, or otherwise improve the therapeutic ratio.","['after surgical resection', '92 patients treated with', 'XXXXX randomized 194 patients with brain metastases to either', 'patients with brain metastases', '92 patients receiving']","['Optimizing whole brain radiotherapy dose and fractionation', 'surgical resection and adjuvant WBRT', 'Whole brain radiotherapy (WBRT', 'WBRT', 'stereotactic radiosurgery alone or WBRT']","['Adverse events', 'OS', 'full course of WBRT', 'intracranial tumor control', 'surgical bed control', 'risk of at least one grade ≥3 adverse event', 'impact time to cognitive failure']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}]","[{'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3846112', 'cui_str': 'Radiosurgery, Stereotactic'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1527390', 'cui_str': 'Neoplasms, Intracranial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",194.0,0.0841696,"This post hoc analysis does not demonstrate that protracted WBRT courses reduce the risk of cognitive deficit, improve tumor control in the hypoxic surgical cavity, or otherwise improve the therapeutic ratio.","[{'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Trifiletti', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida. Electronic address: trifiletti.daniel@mayo.edu.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Weill Medical College of Cornell University, New York, New York.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Brown', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'S Keith', 'Initials': 'SK', 'LastName': 'Anderson', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Xiomara W', 'Initials': 'XW', 'LastName': 'Carrero', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jane H', 'Initials': 'JH', 'LastName': 'Cerhan', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Whitton', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Greenspoon', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ian F', 'Initials': 'IF', 'LastName': 'Parney', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Laack', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Ashman', 'Affiliation': 'Mayo Clinic, Phoenix/Scottsdale, Arizona.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Bahary', 'Affiliation': 'CHUM, Montreal, QC, Canada.'}, {'ForeName': 'Costas G', 'Initials': 'CG', 'LastName': 'Hadjipanayis', 'Affiliation': 'Mount Sinai Beth Israel, New York, New York.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Urbanic', 'Affiliation': 'University of California San Diego, Moores Cancer Center, La Jolla, California.'}, {'ForeName': 'Fred G', 'Initials': 'FG', 'LastName': 'Barker', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Elana', 'Initials': 'E', 'LastName': 'Farace', 'Affiliation': 'Penn State University College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Khuntia', 'Affiliation': 'Precision Cancer Specialists and Varian Medical Systems, Palo Alto, California.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Giannini', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Buckner', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roberge', 'Affiliation': 'CHUM, Montreal, QC, Canada.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2019.10.024']
487,32147032,"The effect of intramuscular megadose of vitamin D injections on E-selectin, CRP and biochemical parameters in vitamin D-deficient patients with type-2 diabetes mellitus: A randomized controlled trial.","BACKGROUND AND AIMS


Inflammatory processes has been shown to be associated with the development of type 2 diabetes mellitus (T2DM) in which vitamin D supplementation might exert beneficial outcomes. We examined the effects of vitamin D supplement on inflammatory and cell adhesion molecule in patients with T2DM.
METHODS


This study consisted of 50 patients with T2DM who had vitamin D deficiency. Participants were randomized into two groups of 25 in which the intervention group received two intramuscular injections of a 200000-IU vitamin D supplement, one at week 0 and another at week 4. The concentrations of fasting blood glucose (FBG), lipid profiles, liver enzymes, E-selectin, C-reactive protein (CRP), calcium, phosphorus, serum 25-hydroxyvitamin D [25(OH)D] and anthropometric indices were obtained before and after 8 weeks.
RESULTS


Vitamin D resulted in significant reductions in CRP(P = 0.01) and gamma glutamyl transferase (GGT) levels(P = 0.03) and significant increases in 25(OH)D concentrations(P = 0.01) in the intervention group compared with the control. Within-group comparisons showed that FBG decreased significantly in the intervention group(P = 0.04). No significant changes were observed regarding within- and between-group comparisons of the other markers.
CONCLUSION


Vitamin D had beneficial effects on the levels of CRP, serum 25(OH)D and GGT among vitamin D deficient patients with T2DM. (http://www.irct.ir: IRCT2017100336539N1).",2020,"RESULTS


Vitamin D resulted in significant reductions in CRP(P = 0.01) and gamma glutamyl transferase (GGT) levels(P = 0.03) and significant increases in 25(OH)D concentrations(P = 0.01) in the intervention group compared with the control.","['patients with T2DM', 'vitamin D-deficient patients with type-2 diabetes mellitus', '50 patients with T2DM who had vitamin D deficiency']","['Vitamin D', 'intramuscular injections of a 200000-IU vitamin D supplement', 'vitamin D supplement', 'vitamin D supplementation', 'vitamin D injections']","['concentrations of fasting blood glucose (FBG), lipid profiles, liver enzymes, E-selectin, C-reactive protein (CRP), calcium, phosphorus, serum', '25-hydroxyvitamin D [25(OH)D] and anthropometric indices', 'levels of CRP, serum 25(OH)D and GGT', 'inflammatory and cell adhesion molecule', 'CRP(P = 0.01) and gamma glutamyl transferase', 'FBG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C4517644', 'cui_str': '200000'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0115305', 'cui_str': 'LECAM-2'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0017040', 'cui_str': 'gammaglutamyltransferase'}]",50.0,0.107329,"RESULTS


Vitamin D resulted in significant reductions in CRP(P = 0.01) and gamma glutamyl transferase (GGT) levels(P = 0.03) and significant increases in 25(OH)D concentrations(P = 0.01) in the intervention group compared with the control.","[{'ForeName': 'Farhang', 'Initials': 'F', 'LastName': 'Mirzavandi', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: farhangfm1371@gmail.com.'}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Talenezhad', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: n.talenezhad@gmail.com.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Razmpoosh', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: e_razmpoosh@yahoo.com.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Nadjarzadeh', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: azadehnajarzadeh@gmail.com.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mozaffari-Khosravi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: Mozaffari.kh@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102346']
488,32147036,Hand heating lowers postprandial blood glucose concentrations: A double-blind randomized controlled crossover trial.,"OBJECTIVES


Examine effect of single hand heating with and without negative pressure on fasting blood glucose (FBG) and postprandial blood glucose (PBG).
DESIGN


Double-blind randomized controlled trial with crossover design.
SUBJECTS


FBG experiment: 17 healthy subjects (4 males). PBG experiment: 13 healthy subjects (1 males).
INTERVENTIONS


Devices included one providing heat only, one heat and negative pressure, and one acting as a sham. For the FBG experiment the devices were used for 30 min. For the PBG experiment the devices were used for one hour during an oral glucose tolerance test (OGTT).
OUTCOME MEASURES


Blood glucose measurements were used to determine change in FBG, peak PBG, area under the curve (AUC), and incremental AUC (iAUC).
RESULTS


Temperature: Change in tympanic temperature was ≤ 0.15 °C for all trials. FBG: There was no effect on FBG. PBG: Compared to the sham device the heat plus vacuum and heat only device lowered peak blood glucose by 16(31)mg/dL, p = 0.092 and 18(28)mg/dL, p = 0.039, respectively. AUC and iAUC: Compared to the sham device, the heat plus vacuum device and heat only device lowered the AUC by 5.1(15.0)%, p = 0.234 and 7.9(11.1)%, p = 0.024 respectively and iAUC by 17.2(43.4)%, p = 0.178 and 20.5(34.5)%, p = 0.054, respectively.
CONCLUSIONS


Heating a single hand lowers postprandial blood glucose in healthy subjects.",2020,"Compared to the sham device the heat plus vacuum and heat only device lowered peak blood glucose by 16(31)mg/dL, p = 0.092 and 18(28)mg/dL, p = 0.039, respectively.","['PBG experiment: 13 healthy subjects (1 males', 'healthy subjects', 'FBG experiment: 17 healthy subjects (4 males']","['PBG', 'Devices included one providing heat only, one heat and negative pressure, and one acting as a sham', 'single hand heating with and without negative pressure', 'Hand heating', 'FBG']","['tympanic temperature', 'postprandial blood glucose concentrations', 'AUC and iAUC', 'Blood glucose measurements', 'peak blood glucose', 'fasting blood glucose (FBG) and postprandial blood glucose (PBG', 'postprandial blood glucose', 'change in FBG, peak PBG, area under the curve (AUC), and incremental AUC (iAUC', 'FBG']","[{'cui': 'C0032704', 'cui_str': '1H-Pyrrole-3-propanoic acid, 5-(aminomethyl)-4-(carboxymethyl)-'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0032704', 'cui_str': '1H-Pyrrole-3-propanoic acid, 5-(aminomethyl)-4-(carboxymethyl)-'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0018851', 'cui_str': 'Heating'}]","[{'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0032704', 'cui_str': '1H-Pyrrole-3-propanoic acid, 5-(aminomethyl)-4-(carboxymethyl)-'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",17.0,0.0996745,"Compared to the sham device the heat plus vacuum and heat only device lowered peak blood glucose by 16(31)mg/dL, p = 0.092 and 18(28)mg/dL, p = 0.039, respectively.","[{'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, United States. Electronic address: Jmoore714@gmail.com.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Kressler', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, United States. Electronic address: Jkressler@sdsu.edu.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Buono', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, United States; Department of Biology, San Diego State University, San Diego, CA, 92182-7251, United States. Electronic address: Mbuono@sdsu.edu.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2019.102280']
489,32147037,Comparison of high-intensity laser therapy and combination of ultrasound treatment and transcutaneous nerve stimulation on cervical pain associated with cervical disc herniation: A randomized trial.,"The aim of the study was to compare the effect of high-intensity laser therapy (HILT) and a combination of transcutaneous nerve stimulation (TENS) and ultrasound (US) treatment on pain, range of motion (ROM) and functional activity on cervical pain associated with cervical disc herniation (CDH). A total of 40 patients (22 women and 18 men) affected by CDH were enrolled in this study. Patients were randomly divided into two groups. In group 1 (20 subjects), patients received 20 sessions of HILT plus exercise, while in group 2 (20 subjects), a combination of US, TENS and exercise were applied. The outcomes were cervical segment ROM, pain level measured by visual analogue scale (VAS), and functional activity measured by neck pain and disability scale (NPADS) before and after the therapy. The level of statistical significance was set as p < 0.05. There was no difference for cervical ROM, VAS and NPADS values between the groups at the baseline (p> 0.05). After the treatment, cervical ROM, VAS and NPADS values were significantly improved in both groups (p < 0.05). When the groups were compared in terms of post treatment VAS, NPADS and ROM values, no statistical significance was found between the two groups (p> 0.05). Both of therapeutic modalities demonstrated analgesic efficacy and improved the function in patients affected by CDH after 4 weeks of therapy (total 20 treatment sessions in 5 days a week). Both the HILT plus exercise program and the TENS / US plus exercise program were found to be effective in improving cervical range of motion and quality of life by reducing pain. These two treatment programs have similar effects in the treatment of cervical pain associated with CDH and can be used as an alternative to each other in clinical applications. However; It is clear that futher studies are needed to investigate the principles of application of HILT to painful areas or tissues (amount of area applied, dose applied, energy delivered, number of pulses, duration of session, frequency of sessions) and to exclude the effects of exercise treatment on the results of both treatment groups.",2020,"There was no difference for cervical ROM, VAS and NPADS values between the groups at the baseline (p> 0.05).","['cervical pain associated with cervical disc herniation (CDH', 'cervical pain associated with cervical disc herniation', '40 patients (22 women and 18 men) affected by CDH were enrolled in this study']","['high-intensity laser therapy and combination of ultrasound treatment and transcutaneous nerve stimulation', 'HILT plus exercise', 'high-intensity laser therapy (HILT) and a combination of transcutaneous nerve stimulation (TENS) and ultrasound (US']","['cervical range of motion and quality of life by reducing pain', 'analgesic efficacy', 'pain, range of motion (ROM) and functional activity', 'cervical segment ROM, pain level measured by visual analogue scale (VAS), and functional activity measured by neck pain and disability scale (NPADS', 'cervical ROM, VAS and NPADS values']","[{'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0410619', 'cui_str': 'Prolapsed cervical intervertebral disc (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0034380'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0222045'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",40.0,0.01524,"There was no difference for cervical ROM, VAS and NPADS values between the groups at the baseline (p> 0.05).","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': 'Istanbul University-Cerrahpasa, Institute of Graduate Studies, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey; Istanbul Medipol University, Health Sciences Institute, Physiotherapy and Rehabilitation Program, Istanbul, Turkey. Electronic address: fzt.mustafayilmaz@gmail.com.'}, {'ForeName': 'Devrim', 'Initials': 'D', 'LastName': 'Tarakci', 'Affiliation': 'Istanbul Medipol University, Faculty of Health Sciences, Department of Ergotherapy, Istanbul, Turkey. Electronic address: dtarakci@medipol.edu.tr.'}, {'ForeName': 'Ela', 'Initials': 'E', 'LastName': 'Tarakci', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Istanbul, Turkey. Electronic address: etarakci@istanbul.edu.tr.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2019.102295']
490,31648764,Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve-Guided Revascularization Strategy.,"OBJECTIVES


This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)- and fractional flow reserve (FFR)-guided revascularization strategies.
BACKGROUND


An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes.
METHODS


This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization.
RESULTS


Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919).
CONCLUSIONS


An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038).",2019,"An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women.","['601 women and 1,891 men']",['iFR- or FFR-guided strategy'],"['mean iFR value', '1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization', 'MACE rates', 'instantaneous wave-free ratio (iFR)- and fractional flow reserve', 'rate of revascularization', 'mean FFR value', 'revascularization rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}]",601.0,0.110612,"An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women.","[{'ForeName': 'Chee Hae', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, VHS Medical Center, Seoul, South Korea.'}, {'ForeName': 'Bon-Kwon', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University, Seoul, South Korea; Institute on Aging, Seoul National University, Seoul, South Korea. Electronic address: bkkoo@snu.ac.kr.'}, {'ForeName': 'Hakim-Moulay', 'Initials': 'HM', 'LastName': 'Dehbi', 'Affiliation': 'Cancer Research UK and University College London Cancer Trials Centre, University College London, London, United Kingdom.'}, {'ForeName': 'Joo Myung', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Department of Medicine, Inje University Ilsan Paik Hospital, Daehwa-dong, South Korea.'}, {'ForeName': 'Chang-Wook', 'Initials': 'CW', 'LastName': 'Nam', 'Affiliation': 'Department of Medicine, Keimyung University Dongsan Medical Center, Daegu, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan Hospital, Ulsan, South Korea.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cook', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Al-Lamee', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Sayan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Iqbal S', 'Initials': 'IS', 'LastName': 'Malik', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Sukhjinder S', 'Initials': 'SS', 'LastName': 'Nijjer', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Hernán', 'Initials': 'H', 'LastName': 'Mejía-Rentería', 'Affiliation': 'Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Alegria-Barrero', 'Affiliation': 'Hospital Universitario de Torrejón, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alghamdi', 'Affiliation': 'King Abdulaziz Medical City Cardiac Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Altman', 'Affiliation': 'Colorado Heart and Vascular, Lakewood, Colorado.'}, {'ForeName': 'Sérgio B', 'Initials': 'SB', 'LastName': 'Baptista', 'Affiliation': 'Hospital Prof. Doutor Fernando Fonseca, Amadora, Portugal.'}, {'ForeName': 'Ravinay', 'Initials': 'R', 'LastName': 'Bhindi', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Bojara', 'Affiliation': 'Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Pedro Canas', 'Initials': 'PC', 'LastName': 'Silva', 'Affiliation': 'Hospital Santa Maria, Lisbon, Portugal.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Mario', 'Affiliation': 'Royal Brompton Hospital, Imperial College London, London, United Kingdom; University of Florence, Florence, Italy.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Pauls Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Gerber', 'Affiliation': 'Conquest Hospital, St Leonards-on-Sea, United Kingdom.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Going', 'Affiliation': 'Sana Klinikum Lichtenberg, Lichtenberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Härle', 'Affiliation': 'Klinikum Oldenburg, European Medical School, Carl von Ossietzky University, Oldenburg, Germany.'}, {'ForeName': 'Farrel', 'Initials': 'F', 'LastName': 'Hellig', 'Affiliation': 'Sunninghill Hospital, Johannesburg, South Africa.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Indolfi', 'Affiliation': 'University Magna Graecia, Catanzaro, Italy.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Imelda Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Jeremias', 'Affiliation': 'Stony Brook University Medical Center, New York, New York.'}, {'ForeName': 'Rajesh K', 'Initials': 'RK', 'LastName': 'Kharbanda', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Khashaba', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Yuetsu', 'Initials': 'Y', 'LastName': 'Kikuta', 'Affiliation': 'Fukuyama Cardiovascular Hospital, Fukuyama, Japan.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krackhardt', 'Affiliation': 'Charite Campus Virchow Klinikum, Universitaetsmedizin, Berlin, Germany.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lehman', 'Affiliation': 'Flinders University, Adelaide, Australia.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Matsuo', 'Affiliation': 'Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Martijin', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Niccoli', 'Affiliation': 'Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'AMC Heart Center, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Flavo', 'Initials': 'F', 'LastName': 'Ribichini', 'Affiliation': 'University Hospital Verona, Verona, Italy.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Samady', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sapontis', 'Affiliation': 'MonashHeart, Monash University, Melbourne, Australia.'}, {'ForeName': 'Arnold H', 'Initials': 'AH', 'LastName': 'Seto', 'Affiliation': 'Veterans Affairs Long Beach Healthcare System, Long Beach, California.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Sezer', 'Affiliation': 'Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'Royal Devon and Exeter Hospital, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Jasvindar', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Takashima', 'Affiliation': 'Aichi Medical University Hospital, Aichi, Japan.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, United Kingdom.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kare', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, United Kingdom; Anglia Ruskin University, Chelmsford, United Kingdom.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Institut Coeur Poumon, Lille University Hospital, Lille, France; UMR INSERM 1011, Centre Hospitalier Universitaire de Lille et de Institut Pasteur de Lille, Université de Lille, Lille, France.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Vinhas', 'Affiliation': 'Hospital Garcia de Horta, Lisbon, Portugal.'}, {'ForeName': 'Christiaan J', 'Initials': 'CJ', 'LastName': 'Vrints', 'Affiliation': 'Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Walters', 'Affiliation': 'Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yokoi', 'Affiliation': 'Fukuoka Sannou Hospital, Fukuoka, Japan.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Samuels', 'Affiliation': 'Cedars-Sinai Heart Institute, Los Angeles, California.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Buller', 'Affiliation': 'St. Michaels Hospital, Toronto, Canada.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke University, Durham, Norh Carolina.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, United Kingdom.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.06.035']
491,31568714,"TMS as a pharmacodynamic indicator of cortical activity of a novel anti-epileptic drug, XEN1101.","OBJECTIVE


Transcranial magnetic stimulation (TMS) produces characteristic deflections in the EEG signal named TMS-evoked EEG potentials (TEPs), which can be used to assess drug effects on cortical excitability. TMS can also be used to determine the resting motor threshold (RMT) for eliciting a minimal muscle response, as a biomarker of corticospinal excitability. XEN1101 is a novel potassium channel opener undergoing clinical development for treatment of epilepsy. We used TEPs and RMT to measure the effects of XEN1101 in the human brain, to provide evidence that XEN1101 alters cortical excitability at doses that might be used in future clinical trials.
METHODS


TMS measurements were incorporated in this Phase I clinical trial to evaluate the extent to which XEN1101 modulates TMS parameters of cortical and corticospinal excitability. TEPs and RMT were collected before and at 2-, 4-, and 6-hours post drug intake in a double-blind, placebo-controlled, randomized, two-period crossover study of 20 healthy male volunteers.
RESULTS


Consistent with previous TMS investigations of antiepileptic drugs (AEDs) targeting ion channels, the amplitude of TEPs occurring at early (15-55 msec after TMS) and at late (150-250 msec after TMS) latencies were significantly suppressed from baseline by 20 mg of XEN1101. Furthermore, the RMT showed a significant time-dependent increase that correlated with the XEN1101 plasma concentration.
INTERPRETATION


Changes from baseline in TMS measures provided evidence that 20 mg of XEN1101 suppressed cortical and corticospinal excitability, consistent with the effects of other AEDs. These results support the implementation of TMS as a tool to inform early-stage clinical trials.",2019,"INTERPRETATION


Changes from baseline in TMS measures provided evidence that 20 mg of XEN1101 suppressed cortical and corticospinal excitability, consistent with the effects of other AEDs.",['20 healthy male volunteers'],"['TMS', 'placebo', 'Transcranial magnetic stimulation (TMS', 'XEN1101']","['latencies', 'XEN1101 plasma concentration', 'TEPs and RMT']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0145334', 'cui_str': 'Pyrazine, tetraethyl-'}]",20.0,0.121632,"INTERPRETATION


Changes from baseline in TMS measures provided evidence that 20 mg of XEN1101 suppressed cortical and corticospinal excitability, consistent with the effects of other AEDs.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Premoli', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Pierre G', 'Initials': 'PG', 'LastName': 'Rossini', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul Y', 'Initials': 'PY', 'LastName': 'Goldberg', 'Affiliation': 'Xenon Pharmaceuticals Inc., Burnaby, Canada.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Posadas', 'Affiliation': ""Clinical Research Facility, King's College Hospital, London, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': ""Clinical Research Facility, King's College Hospital, London, UK.""}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Yogo', 'Affiliation': ""Clinical Research Facility, King's College Hospital, London, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Pimstone', 'Affiliation': 'Xenon Pharmaceuticals Inc., Burnaby, Canada.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Abela', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Gregory N', 'Initials': 'GN', 'LastName': 'Beatch', 'Affiliation': 'Xenon Pharmaceuticals Inc., Burnaby, Canada.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Richardson', 'Affiliation': ""Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Annals of clinical and translational neurology,['10.1002/acn3.50896']
492,31254451,Racial Differences in Performance-Based Function and Potential Explanatory Factors Among Individuals With Knee Osteoarthritis.,"OBJECTIVE


In individuals with knee osteoarthritis (OA), self-reported physical function is poorer in African Americans than in whites, but whether this difference holds true for objective assessments is unclear. The purpose of this study was to examine racial differences in performance-based physical function as well as potential underlying factors contributing to these racial differences.
METHODS


Participants with knee OA from a randomized controlled trial completed the 2-minute step test (2MST), timed-up-and-go (TUG), and 30-second chair stand (30s-CST) at baseline. Race differences in performance-based function were assessed by logistic regression. Separate models were adjusted for sets of demographic, socioeconomic, psychological health, and physical health variables.
RESULTS


In individuals with knee OA (n = 322; 72% women, 22% African American, mean ± SD age 66 ± 11 years, mean ± SD body mass index 31 ± 8 kg/m 2  ), African Americans (versus whites) had greater unadjusted odds of poorer function (30s-CST odds ratio [OR] 2.79 [95% confidence interval (95% CI) 1.65-4.72], 2MST OR 2.37 [95% CI 1.40-4.03], and TUG OR 3.71 [95% CI 2.16-6.36]). Relationships were maintained when adjusted for demographic and psychological health covariates, but they were either partially attenuated or nonsignificant when adjusted for physical health and socioeconomic covariates.
CONCLUSION


African American adults with knee OA had poorer unadjusted performance-based function than whites. Physical health and socioeconomic characteristics diminished these differences, emphasizing the fact that these factors may be important to consider in mitigating racial disparities in function.",2020,"Relationships were maintained when adjusted for demographic and psychological health covariates, but they were either partially attenuated or non-significant when adjusted for physical health and socioeconomic covariates.
","['Participants with knee OA', 'persons with knee OA (n=322; women: 72%, Black: 22%, age=66±11 years, BMI=31±8 kg/m 2  ), Blacks (vs. Whites) had greater unadjusted odds of poorer function (30s-CST: OR [95% CI] = 2.79 [1.65-4.72', 'people with knee osteoarthritis (OA', 'individuals with knee osteoarthritis']","['2MST', '2-minute step tests (2MST), timed-up-and-go (TUG), and 30-second chair stands']",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]",[],322.0,0.120359,"Relationships were maintained when adjusted for demographic and psychological health covariates, but they were either partially attenuated or non-significant when adjusted for physical health and socioeconomic covariates.
","[{'ForeName': 'Portia P E', 'Initials': 'PPE', 'LastName': 'Flowers', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Schwartz', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Liubov', 'Initials': 'L', 'LastName': 'Arbeeva', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Yvonne M', 'Initials': 'YM', 'LastName': 'Golightly', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Comprehensive Physical Therapy Center, Chapel Hill, North Carolina.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cooke', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Jyotsna J', 'Initials': 'JJ', 'LastName': 'Gupta', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Leigh F', 'Initials': 'LF', 'LastName': 'Callahan', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Goode', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Corsi', 'Affiliation': 'Northeastern Ohio Medical University, Rootstown, Ohio.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Huffman', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Kelli D', 'Initials': 'KD', 'LastName': 'Allen', 'Affiliation': 'University of North Carolina at Chapel Hill and Durham VA Medical Center, Durham, North Carolina.'}]",Arthritis care & research,['10.1002/acr.24018']
493,30747501,"Etanercept and Methotrexate as Monotherapy or in Combination for Psoriatic Arthritis: Primary Results From a Randomized, Controlled Phase III Trial.","OBJECTIVE


To examine the efficacy of methotrexate monotherapy relative to etanercept monotherapy and the value of combining methotrexate and etanercept for the treatment of patients with psoriatic arthritis (PsA).
METHODS


In this double-blind study, 851 patients with PsA were randomized to 1 of 3 treatment arms, as follows: oral methotrexate (20 mg) plus subcutaneous placebo given weekly (n = 284), subcutaneous etanercept (50 mg) plus oral placebo given weekly (n = 284), or subcutaneous etanercept (50 mg) plus oral methotrexate (20 mg) given weekly (combination therapy; n = 283). The American College of Rheumatology 20% improvement (ACR20) response and Minimal Disease Activity (MDA) response at week 24 were the primary end point and key secondary end point, respectively. Other measures of inflammatory arthritis, radiographic progression, and nonarticular disease manifestations were also assessed.
RESULTS


Patients with PsA had a mean ± SD age of 48.4 ± 13.1 years, and the mean ± SD duration of PsA was 3.2 ± 6.3 years (median 0.6 years). ACR20 and MDA response rates at week 24 were significantly greater in patients who received etanercept monotherapy compared with those who received methotrexate monotherapy (ACR20, 60.9% versus 50.7% of patients [P = 0.029]; MDA, 35.9% versus 22.9% of patients [P = 0.005]), and both were significantly greater in the combination therapy group compared with the methotrexate monotherapy group at week 24 (ACR20, 65.0% versus 50.7% of patients [P = 0.005]; MDA, 35.7% versus 22.9% of patients [P = 0.005]). Other secondary outcomes (ACR50 and ACR70 response rates, proportions of patients achieving a Very Low Disease Activity score, and PsA disease activity scores) showed between-group differences that were consistent with the primary and key secondary end point results. Furthermore, patients in both etanercept treatment arms showed less radiographic progression at week 48 compared with patients who received methotrexate monotherapy. Outcomes were similar in the combination therapy and etanercept monotherapy groups, except for some skin end points. No new safety signals were seen.
CONCLUSION


Etanercept monotherapy and combination therapy with etanercept and methotrexate showed greater efficacy than methotrexate monotherapy in patients with PsA, according to the ACR and MDA response rates and extent of radiographic progression at follow-up. Overall, combining methotrexate and etanercept did not improve the efficacy of etanercept.",2019,"Etanercept monotherapy and combination therapy with etanercept and methotrexate showed greater efficacy than methotrexate monotherapy in patients with PsA, according to the ACR and MDA response rates and extent of radiographic progression at follow-up.","['851 patients with PsA', 'patients with psoriatic arthritis (PsA', 'Psoriatic Arthritis', 'Patients with PsA had a mean ± SD age of 48.4 ± 13.1 years, and the mean ± SD duration of PsA was 3.2 ± 6.3 years (median 0.6 years', 'patients with PsA']","['subcutaneous etanercept (50 mg) plus oral methotrexate', 'methotrexate monotherapy', 'oral methotrexate (20 mg) plus subcutaneous placebo', 'Etanercept and Methotrexate', 'methotrexate and etanercept', 'subcutaneous etanercept (50 mg) plus oral placebo', 'etanercept and methotrexate']","['secondary outcomes (ACR50 and ACR70 response rates, proportions of patients achieving a Very Low Disease Activity score, and PsA disease activity scores', 'ACR20 and MDA response rates', 'improvement (ACR20) response and Minimal Disease Activity (MDA) response', 'inflammatory arthritis, radiographic progression, and nonarticular disease manifestations', 'ACR and MDA response rates and extent of radiographic progression', 'radiographic progression', 'efficacy of etanercept']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}]",851.0,0.0891848,"Etanercept monotherapy and combination therapy with etanercept and methotrexate showed greater efficacy than methotrexate monotherapy in patients with PsA, according to the ACR and MDA response rates and extent of radiographic progression at follow-up.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health and the University of Washington, Seattle, Washington.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Collier', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Ritchlin', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Lyrica', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kricorian', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Chung', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.40851']
494,31033232,Effect of Group-Based Outpatient Physical Therapy on Function After Total Knee Replacement: Results From a Multicenter Randomized Controlled Trial.,"OBJECTIVE


To evaluate the long-term clinical effectiveness of a novel group-based outpatient physical therapy (PT) following total knee replacement (TKR).
METHODS


In this 2-center, unblinded, superiority, randomized controlled trial, 180 patients on a waiting list for primary TKR due to osteoarthritis were randomized to a 6 session group-based outpatient PT intervention and usual care (n = 89) or usual care alone (n = 91). The primary outcome was patient-reported functional ability measured by the Lower Extremity Functional Scale at 12 months postoperative. Secondary outcomes included knee symptoms, depression, anxiety, and satisfaction. Questionnaires were completed preoperatively and at 3, 6, and 12 months postoperatively.
RESULTS


The mean difference in function between groups was 4.47 (95% confidence interval [95% CI] 0.20, 8.75; P = 0.04) at 12 months postoperative, favoring the intervention. The mean difference in function between groups decreased over time, from 8.1 points at 3 months (95% CI 3.8, 12.4; P < 0.001) to 5.4 (95% CI 1.1, 9.8; P = 0.015) at 6 months postoperative. There were no clinically relevant differences in any secondary outcomes between groups, although patients in the intervention group were more likely to be satisfied with their PT. No serious adverse events related to the intervention were reported.
CONCLUSION


Supplementing usual care with this group-based outpatient PT intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimum clinically important difference of 9 points. However, patient satisfaction was higher in the intervention group, and there was some evidence of clinically relevant improvements in function at 3 months.",2020,"Supplementing usual care with this group-based outpatient physiotherapy intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimal clinically important different of 9 points.","['function after total knee replacement', '180 patients on a waiting list for primary TKR due to osteoarthritis']","['6 session group-based outpatient physiotherapy intervention and usual care (n=89) or usual care alone', 'novel group-based outpatient physiotherapy following total knee replacement (TKR', 'group-based outpatient physiotherapy']","['knee symptoms, depression, anxiety and satisfaction', 'patient satisfaction', 'patient-reported functional ability measured by the Lower Extremity Functional Scale']","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale (assessment scale)'}]",180.0,0.145058,"Supplementing usual care with this group-based outpatient physiotherapy intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimal clinically important different of 9 points.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lenguerrand', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Artz', 'Affiliation': 'University of West of England, Bristol, UK.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Marques', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sanderson', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': 'University of Bristol and Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Tarique', 'Initials': 'T', 'LastName': 'Parwez', 'Affiliation': 'Luton and Dunstable Hospital, Luton and Dunstable University Hospital NHS Foundation Trust, Luton, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Bertram', 'Affiliation': 'University of Bristol and Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Beswick', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Burston', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'University of Bristol and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Ashley W', 'Initials': 'AW', 'LastName': 'Blom', 'Affiliation': 'University of Bristol, Southmead Hospital, North Bristol NHS Trust, and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Wylde', 'Affiliation': 'University of Bristol and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}]",Arthritis care & research,['10.1002/acr.23909']
495,31811950,Genetic Variant Associated With Survival of Patients With Stage II-III Colon Cancer.,"BACKGROUND & AIMS


Many genetic variants have been associated with colorectal cancer risk, although few have been associated with survival times of patients. Identification of genetic variants associated with survival times might improve our understanding of disease progression and aid in outcome prediction. We performed a genome-wide association study to identify variants associated with colon cancer survival time.
METHODS


We performed a post hoc analysis of data from NCCTG N0147 (Alliance), a randomized phase 3 trial of patients with resected stage III colon cancer, and from NSABP C-08 (NRG), a phase 3 trial that compared therapy regimens for patients with resected stage II or III colon cancer. Genotype analyses were performed on DNA from blood samples from 4974 patients. We used Cox proportional hazards regression to evaluate the association of each single nucleotide polymorphism with times of overall survival and disease-free survival, adjusting for age at diagnosis, sex, treatment group, and principal components of genetic ancestry. We performed the analysis for studies N0147 and C-08 separately, and results were combined in a fixed-effects meta-analysis.
RESULTS


A locus on chromosome 7p15.2 was significantly associated with overall survival time (P ≤ 5x10 -08 ). The most significant variant at this locus, rs76766811 (P = 1.6x10 -08 ), is common among African Americans (minor allele frequency, approximately 18%) but rare in European Americans (minor allele frequency <0.1%). Within strata of self-reported ancestry, this variant was associated with times of overall survival and disease-free survival in only African Americans (hazard ratio for overall survival, 2.82; 95% CI, 1.88-4.23; P = 5.0x10 -07  and hazard ratio for disease-free survival, 2.27; 95% CI, 1.62-3.18; P = 1.8x10 -06 ).
CONCLUSIONS


In an analysis of data from 2 trials of patients with stage II or III colon cancer, we identified rs76766811 as a potential prognostic variant in African American patients. This finding should be confirmed in additional study populations. ClinicalTrials.gov Identifiers: NCT00096278 (NSABP C-08) and NCT00079274 (NCCTG N0147).",2019,A locus on chromosome 7p15.2 was significantly associated with overall survival time (P≤5x10 -08 ).,"['African American patients', '4974 patients', 'patients with resected stage III colon cancer, and from NSABP C-08 (NRG), a phase 3 trial that compared therapy regimens for patients with resected stage II or III colon cancer', 'patients with stage II or III colon cancer', 'Patients with Stage II-III Colon Cancer']",[],"['overall survival time', 'overall survival and disease-free survival', 'colon cancer survival time']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]",4974.0,0.294248,A locus on chromosome 7p15.2 was significantly associated with overall survival time (P≤5x10 -08 ).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Penney', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Banbury', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Bien', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Tabitha A', 'Initials': 'TA', 'LastName': 'Harrison', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Xinwei', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Amanda I', 'Initials': 'AI', 'LastName': 'Phipps', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Amit D', 'Initials': 'AD', 'LastName': 'Joshi', 'Affiliation': 'Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Carmen J', 'Initials': 'CJ', 'LastName': 'Allegra', 'Affiliation': 'University of Florida, Gainesville, Florida; NRG Oncology, Pittsburgh, Pennsylvania.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Atkins', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Colangelo', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'George', 'Affiliation': 'University of Florida, Gainesville, Florida; NRG Oncology, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; West Virginia University Cancer Institute, Morgantown, West Virginia.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Lucas', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Suresh G', 'Initials': 'SG', 'LastName': 'Nair', 'Affiliation': 'Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota; Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; Allegheny Health Network Cancer Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Yothers', 'Affiliation': 'NRG Oncology, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Peters', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Polly A', 'Initials': 'PA', 'LastName': 'Newcomb', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington; University of Washington, Seattle, Washington.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Clinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts. Electronic address: achan@mgh.harvard.edu.""}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.11.046']
496,32118713,Clinical effects of hemoperfusion combined with pulse high-volume hemofiltration on septic shock.,"Sepsis can cause septic shock, multiple organ dysfunction and even death. The combination of different blood purification would be the certain trend in the treatment of sepsis.This study was to evaluate the clinical effects of hemoperfusion (HP) combined with pulse high volume hemofiltration (PHVHF) on septic shock.Thirty cases were involved in this study and were randomly divided into two groups: HP and PHVHF group (n = 15) and CVVH (continuous veno-venous hemofiltration) group (n = 15). Acute physiology and chronic health evaluation (APACHE) II scores, sequential organ failure assessment (SOFA) scores as well as biochemical changes were measured before and after the treatment. The levels of IL-6, IL-10, and TNF-α in plasma were assessed by ELISA before and after treatment for 2 and 24 h. The norepinephrine doses were also analyzed. The 28-day mortalities in both groups were also compared.In both groups, body temperature (BT), respiratory rate (RR), white blood cells (WBC), C-reactive protein (CRP), Procalcitonin (PCT), lactic acid, serum creatinine, APACHE II scores and SOFA scores decreased after hemofiltration (P < .05). The HP&PHVHF group was superior to the CVVH group in CRP, APACHE II score (P < .01), and heart rate (HR), WBC, PCT, SOFA (P < .05). The doses of norepinephrine were also decreased after treatment (P < .01), with more reduction in the HP&PHVHF group (P < .05). After 24 h of treatment, the levels of IL-6, IL-10, and TNF-α decreased in both groups (P < .05), and the decrease was more significant in HP&PHVHF group (P < .05). In combined group, after 2 h of hemoperfison, there was a significant reduction in these inflammatory factors (P < .01). Combined therapy group's mortality was 26.7%, while CVVH group's was 40%.HP combined with PHVHF has a significant effect on septic shock and can be an important therapy for septic shock.",2020,"After 24 h of treatment, the levels of IL-6, IL-10, and TNF-α decreased in both groups (P < .05), and the decrease was more significant in HP&PHVHF group (P < .05).","['Thirty cases', 'septic shock']","['HP&PHVHF', 'CVVH', 'norepinephrine', 'hemoperfusion combined with pulse high-volume hemofiltration', 'hemoperfusion (HP) combined with pulse high volume hemofiltration (PHVHF', 'CVVH (continuous veno-venous hemofiltration', 'PHVHF', 'HP and PHVHF']","['inflammatory factors', 'body temperature (BT), respiratory rate (RR), white blood cells (WBC), C-reactive protein (CRP), Procalcitonin (PCT), lactic acid, serum creatinine, APACHE II scores and SOFA scores', 'heart rate (HR), WBC, PCT, SOFA', 'mortality', 'Acute physiology and chronic health evaluation (APACHE) II scores, sequential organ failure assessment (SOFA) scores', 'septic shock', 'levels of IL-6, IL-10, and TNF-α in plasma', 'levels of IL-6, IL-10, and TNF-α', '28-day mortalities', 'CRP, APACHE II score']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}]","[{'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0019063', 'cui_str': 'Hemosorption'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0019014', 'cui_str': 'Hemofiltration'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}]","[{'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0064582', 'cui_str': 'Lactic acid'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0243028', 'cui_str': 'APACHE II'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0377041,"After 24 h of treatment, the levels of IL-6, IL-10, and TNF-α decreased in both groups (P < .05), and the decrease was more significant in HP&PHVHF group (P < .05).","[{'ForeName': 'Laping', 'Initials': 'L', 'LastName': 'Chu', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Jiangnan University, Wuxi.'}, {'ForeName': 'Guangyao', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing.'}, {'ForeName': 'Yafen', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Jiangnan University, Wuxi.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': 'Department of Nephrology, Affiliated Hospital of Jiangnan University, Wuxi.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Department of Intensive Care Unit, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu Province, China.'}, {'ForeName': 'Minhong', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Department of Intensive Care Unit, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu Province, China.'}]",Medicine,['10.1097/MD.0000000000019058']
497,30440874,Combined Visual Feedback with Pelvic Assistance Force Improves Step Length during treadmill walking in Individuals with Post-Stroke Hemiparesis.,"Altered spatiotemporal gait characteristics are common impairments after stroke. Visual feedback has been used to improve spatiotemporal gait characteristics. In addition, pelvic assistance force applied in the mediolateral direction to the paretic side can improve walking pattern. Potentially, combined visual feedback and pelvic assistance force can have better rehabilitation outcomes on walking patterns. The purpose of this study was compare the effects of combined visual feedback with pelvic assistance force and visual feedback only during treadmill walking in individuals with post-stroke hemiparesis. Fifteen subjects with hemiparesis due to chronic (>6 months) stroke participated. A computer monitor placed in front of the treadmill was used to provide visual feedback on subjects' weight bearing on the paretic leg. A customized cabledriven robotic system was used to apply pelvic assistance force. The magnitude of pelvic assistance force was 9% of body weight. The session consisted of 5 sections: 1-min baseline, 7-min treadmill training (visual feedback only or combined visual feedback and pelvic assistance force), 1-min post-training (no visual feedback or pelvic assistance force), 1-min standing break, and 5-min treadmill training. The order of the visual feedback only and combined visual feedback and pelvic assistance force sessions was randomized across subjects. Spatiotemporal gait variables within the session, including stance time, single leg support time and step length, were computed. Combined visual feedback with pelvic assistance force resulted in a better improvement in step length of the paretic leg when compared to visual feedback only (p=0.03). Walking patterns after stroke could potentially be improved by applying visual feedback regrading paretic leg weight bearing and pelvic assistance force. Future study is needed to confirm the effectiveness of visual feedback for treadmill training after stroke.",2018,Combined visual feedback with pelvic assistance force resulted in a better improvement in step length of the paretic leg when compared to visual feedback only (p=0.03).,"['Fifteen subjects with hemiparesis due to chronic (>6 months) stroke participated', 'Individuals with Post-Stroke Hemiparesis', ""subjects' weight bearing on the paretic leg"", 'individuals with post-stroke hemiparesis']","['5 sections: 1-min baseline, 7-min treadmill training (visual feedback only or combined visual feedback and pelvic assistance force), 1-min post-training (no visual feedback or pelvic assistance force), 1-min standing break, and 5-min treadmill training', 'Combined Visual Feedback with Pelvic Assistance Force', 'combined visual feedback with pelvic assistance force and visual feedback']","['pelvic assistance force', 'stance time, single leg support time and step length', 'step length of the paretic leg']","[{'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}]",15.0,0.0283405,Combined visual feedback with pelvic assistance force resulted in a better improvement in step length of the paretic leg when compared to visual feedback only (p=0.03).,"[{'ForeName': 'Chao-Jung', 'Initials': 'CJ', 'LastName': 'Hsu', 'Affiliation': ''}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2018.8512811']
498,30209271,Parental interest in genomic sequencing of newborns: enrollment experience from the BabySeq Project.,"PURPOSE


Newborn genomic sequencing (nGS) has great potential to improve pediatric care. Parental interest and concerns about genomics are relatively unexplored. Understanding why parents decline research consent for nGS may reveal implementation barriers.
METHODS


We evaluated parental interest in a randomized trial of nGS in well-baby and intensive care unit nursery settings. Interested families attended an informational enrollment session (ES) with a genetic counselor prior to consenting. Reason(s) for declining participation and sociodemographic associations were analyzed.
RESULTS


Of 3860 eligible approached families, 10% attended ES, 67% of whom enrolled. Of 1760 families queried for decline reasons, 58% were uninterested in research. Among 499 families considering research, principal reasons for decline prior to ES included burdensome study logistics (48%), feeling overwhelmed postpartum (17%), and lack of interest/discomfort with genetic testing (17%). Decliners after ES more often cited concerns about privacy/insurability (41%) and uncertain/unfavorable results (23%).
CONCLUSION


Low interest in research and study logistics were major initial barriers to postpartum enrollment and are likely generic to many postpartum research efforts. Concerns over privacy and result implications were most commonly cited in decliners after ES. Understanding parental concerns around research nGS may inform future integration of nGS into newborn screening, predictive testing, and pediatric diagnostics.",2019,"Decliners after ES more often cited concerns about privacy/insurability (41%) and uncertain/unfavorable results (23%).
","['well-baby and intensive care unit nursery settings', 'Of 3860 eligible approached families, 10% attended ES, 67% of whom enrolled', '1760 families queried for decline reasons, 58% were uninterested in research', '499 families considering research, principal reasons for decline prior to ES included burdensome study logistics (48%), feeling overwhelmed postpartum (17%), and lack of interest/discomfort with genetic testing (17']","['nGS', 'Newborn genomic sequencing (nGS']",[],"[{'cui': 'C0458075', 'cui_str': 'Well baby (finding)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0035168'}, {'cui': 'C0401925', 'cui_str': 'Teaching principal (occupation)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0424091', 'cui_str': 'Loss of interest (finding)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0679560', 'cui_str': 'Genetic Testing'}]","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}]",[],3860.0,0.0448702,"Decliners after ES more often cited concerns about privacy/insurability (41%) and uncertain/unfavorable results (23%).
","[{'ForeName': 'Casie A', 'Initials': 'CA', 'LastName': 'Genetti', 'Affiliation': ""Division of Genetics and Genomics and The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Talia S', 'Initials': 'TS', 'LastName': 'Schwartz', 'Affiliation': ""Division of Genetics and Genomics and The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Jill O', 'Initials': 'JO', 'LastName': 'Robinson', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'VanNoy', 'Affiliation': ""Division of Genetics and Genomics and The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Devan', 'Initials': 'D', 'LastName': 'Petersen', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Pereira', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Fayer', 'Affiliation': ""Department of Medicine, Division of Genetics, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Hayley A', 'Initials': 'HA', 'LastName': 'Peoples', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Pankaj B', 'Initials': 'PB', 'LastName': 'Agrawal', 'Affiliation': ""Division of Genetics and Genomics and The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Wendi N', 'Initials': 'WN', 'LastName': 'Betting', 'Affiliation': ""Department of Medicine, Division of Genetics, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Holm', 'Affiliation': ""Division of Genetics and Genomics and The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'McGuire', 'Affiliation': 'Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Waisbren', 'Affiliation': ""Division of Genetics and Genomics and The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Yu', 'Affiliation': ""Division of Genetics and Genomics and The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Green', 'Affiliation': ""Department of Medicine, Division of Genetics, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Beggs', 'Affiliation': ""Division of Genetics and Genomics and The Manton Center for Orphan Disease Research, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Parad', 'Affiliation': ""Department of Medicine, Division of Genetics, Brigham and Women's Hospital, Boston, Massachusetts, USA. rparad@bwh.harvard.edu.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-018-0105-6']
499,32143995,Effects of six months of aerobic and resistance training on metabolic markers and bone mineral density in older men on androgen deprivation therapy for prostate cancer.,"BACKGROUND


Androgen deprivation therapy (ADT) for prostate cancer (PCa) is associated with metabolic perturbations and declines in bone mineral density (BMD). Exercise interventions provide multiple health benefits to older men on ADT; however, their effect on metabolic biomarkers and BMD remains unclear.
METHODS


A secondary analysis of a phase II randomized controlled trial was conducted to assess the effect of a six-month moderate-intensity aerobic and resistance exercise program on metabolic biomarkers and BMD in men on ADT. Participants were randomized to three different exercise delivery models: personal training; supervised group exercise; or home-based exercise. Analysis of metabolic biomarkers (lipid profile and glucose) was conducted at baseline, six and twelve months. BMD of the lumbar spine, femoral neck and hip were assessed at baseline and twelve months. Both within- and between-group analyses of change scores adjusted for baseline values were performed.
RESULTS


Forty-eight men (mean age 69.8y) were enrolled. Baseline values of metabolic biomarkers and BMD were comparable between groups and the three groups were combined for the primary analysis. At six months, no changes in metabolic biomarkers were found; however, at twelve months low-density lipoprotein (+0.28 mmol/L; 95%CI, 0.04 to 0.51) and total cholesterol (+0.31 mmol/L; 95%CI, 0.00 to 0.61) were significantly increased from baseline. No changes were found in BMD. In a secondary between-group analysis, no improvements were observed for any metabolic biomarker or BMD measurement.
CONCLUSIONS


Different exercise prescription parameters (modality and intensity) or combined diet/exercise interventions may be needed to foster favorable metabolic and skeletal adaptations during ADT.",2020,No changes were found in BMD.,"['older men on ADT', 'older men on androgen deprivation therapy for prostate cancer', 'men on ADT', 'Forty-eight men (mean age 69.8y) were enrolled', 'prostate cancer (PCa']","['exercise delivery models: personal training; supervised group exercise; or home-based exercise', 'Androgen deprivation therapy (ADT', 'six-month moderate-intensity aerobic and resistance exercise program', 'Exercise interventions', 'Different exercise prescription parameters (modality and intensity) or combined diet/exercise interventions', 'aerobic and resistance training']","['metabolic biomarkers (lipid profile and glucose', 'BMD of the lumbar spine, femoral neck and hip', 'BMD', 'metabolic biomarkers', 'Baseline values of metabolic biomarkers and BMD', 'total cholesterol', 'metabolic biomarkers and BMD', 'bone mineral density (BMD', 'metabolic biomarker or BMD measurement', 'metabolic markers and bone mineral density']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030625', 'cui_str': 'PCA'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1276393', 'cui_str': 'Group exercise (regime/therapy)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",48.0,0.07774,No changes were found in BMD.,"[{'ForeName': 'Efthymios', 'Initials': 'E', 'LastName': 'Papadopoulos', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2W6, Canada; Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada. Electronic address: efthymios.papadopoulos@mail.utoronto.ca.'}, {'ForeName': 'Daniel Santa', 'Initials': 'DS', 'LastName': 'Mina', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2W6, Canada; Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, AB T2N 1N4, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Durbano', 'Affiliation': 'Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ritvo', 'Affiliation': 'York University, Toronto, ON M3J 1P3, Canada.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Sabiston', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5S 2W6, Canada.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Krahn', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto ON M5S 1A1, Canada; Faculty of Medicine, University of Toronto, Toronto ON M5S 1A8, Canada; Toronto General Hospital Research Institute, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tomlinson', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto ON M5S 1A1, Canada; Faculty of Medicine, University of Toronto, Toronto ON M5S 1A8, Canada; Toronto General Hospital Research Institute, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': ""O'Neill"", 'Affiliation': 'Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Iqbal', 'Affiliation': 'Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Narhari', 'Initials': 'N', 'LastName': 'Timilshina', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto ON M5S 1A1, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Matthew', 'Affiliation': 'Cancer Clinical Research Unit, University Health Network, Toronto, ON M5G 2C1, Canada; Faculty of Medicine, University of Toronto, Toronto ON M5S 1A8, Canada.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': 'Warde', 'Affiliation': 'Cancer Clinical Research Unit, University Health Network, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Shabbir M H', 'Initials': 'SMH', 'LastName': 'Alibhai', 'Affiliation': 'Department of Supportive Care, University Health Network, Toronto, ON M5G 2C4, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto ON M5S 1A1, Canada; Faculty of Medicine, University of Toronto, Toronto ON M5S 1A8, Canada.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2020.02.013']
500,32144833,"The effect of resveratrol supplementation on serum levels of asymmetric de-methyl-arginine and paraoxonase 1 activity in patients with type 2 diabetes: A randomized, double-blind controlled trial.","The present study sought to investigate the effect of micronized resveratrol supplementation on serum levels of asymmetric de-methyl-arginine (ADMA) and paraoxonase-1 (PON1) activity in patients with type 2 diabetes (T2D). In this double-blinded randomized trial, 76 patients with T2D were recruited. Participants were randomly assigned to consume 1,000 mg resveratrol or placebo capsules (methylcellulose) per day, for 8 weeks. Serum levels of ADMA and PON1 enzyme activity were measured at the beginning and end of the intervention using the enzyme-linked immunosorbent assay method. In total, 71 participants completed the study. Our results showed that resveratrol significantly decreased serum levels of ADMA (-0.16 ± 0.11, p < .001) and improved PON1 enzyme activity (15.39 ± 13.99, p < .001) compared with placebo, after adjusting for confounding factors (age, sex, and baseline body mass index). Our findings suggest that 8-week resveratrol supplementation may produce beneficial effects on serum levels of ADMA and PON1 enzyme activity in patients with T2DM. However, further research is needed to confirm the veracity of these results.",2020,"Our results showed that resveratrol significantly decreased serum levels of ADMA (-0.16 ± 0.11, p < .001) and improved PON1 enzyme activity (15.39 ± 13.99, p < .001) compared with placebo, after adjusting for confounding factors (age, sex, and baseline body mass index).","['71 participants completed the study', 'patients with type 2 diabetes', '76 patients with T2D were recruited', 'patients with T2DM', 'patients with type 2 diabetes (T2D']","['consume 1,000\u2009mg resveratrol or placebo', 'micronized resveratrol supplementation', 'placebo', 'resveratrol supplementation']","['PON1 enzyme activity', 'Serum levels of ADMA and PON1 enzyme activity', 'serum levels of ADMA', 'serum levels of ADMA and PON1 enzyme activity', 'serum levels of asymmetric de-methyl-arginine (ADMA) and paraoxonase-1 (PON1) activity']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C1121571', 'cui_str': 'Paraoxonase 1'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",76.0,0.344008,"Our results showed that resveratrol significantly decreased serum levels of ADMA (-0.16 ± 0.11, p < .001) and improved PON1 enzyme activity (15.39 ± 13.99, p < .001) compared with placebo, after adjusting for confounding factors (age, sex, and baseline body mass index).","[{'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Tabatabaie', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Abdollahi', 'Affiliation': 'Department of Nutrition and Public Health, School of Public Health, North Khorasan University, Bojnurd, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Salehi-Abargouei', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Cain C T', 'Initials': 'CCT', 'LastName': 'Clark', 'Affiliation': 'Centre for Sport, Exercise, and Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Karimi-Nazari', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Fallahzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Research Center of Prevention and Epidemiology of Non-Communicable Disease, School of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Rahmanian', 'Affiliation': 'Yazd Diabetic Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mozaffari-Khosravi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6655']
501,30283029,"Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).","Numerous placebo-controlled studies have demonstrated the ability of ketamine, an NMDA receptor antagonist, to induce rapid (within hours), transient antidepressant effects when administered intravenously (IV) at subanesthetic doses (0.5 mg/kg over 40 min). However, the optimal antidepressant dose remains unknown. We aimed to compare to active placebo the rapid acting antidepressant properties of a broad range of subanesthetic doses of IV ketamine among outpatients with treatment-resistant depression (TRD). A range of IV ketamine doses were compared to active placebo in the treatment of adult TRD over a 3-day period following a single infusion over 40 min. This was an outpatient study conducted across six US academic sites. Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode. Following a washout period, 99 eligible subjects were randomly assigned to one of the five arms in a 1:1:1:1:1 fashion: a single intravenous dose of ketamine 0.1 mg/kg (n = 18), a single dose of ketamine 0.2 mg/kg (n = 20), a single dose of ketamine 0.5 mg/kg (n = 22), a single dose of ketamine 1.0 mg/kg (n = 20), and a single dose of midazolam 0.045 mg/kg (active placebo) (n = 19). The study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I) were performed at days 0, 1, 3 (endpoint), 5, 7, 14, and 30 to assess the safety and efficacy. The overall group × time interaction effect was significant for the primary outcome measure, the HAM-D-6. In post hoc pairwise comparisons controlling for multiple comparisons, standard dose (0.5 mg/kg) and high dose (1 mg/kg) of intravenous ketamine were superior to active placebo; a low dose (0.1 mg/kg) was significant only prior to adjustment (p = 0.02, p-adj = 0.14, d = -0.82 at day 1). Most of the interaction effect was due to differences at day 1, with no significant adjusted pairwise differences at day 3. This pattern generally held for secondary outcomes. The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses. Our results suggest that there is evidence for the efficacy of the 0.5 mg/kg and 1.0 mg/kg subanesthetic doses of IV ketamine and no clear or consistent evidence for clinically meaningful efficacy of lower doses of IV ketamine. Trial Registration: NCT01920555.",2020,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","['99 eligible subjects', 'Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode', 'treatment-resistant depression (TRD', 'outpatients with treatment-resistant depression (TRD']","['ketamine', 'IV ketamine', 'placebo', 'midazolam 0.045\u2009mg/kg (active placebo', 'ketamine 0.1\u2009mg/kg']","['safety and efficacy', 'HAM-D-6', 'dissociative symptoms and transient blood pressure elevations', 'study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517410', 'cui_str': 'Zero point zero four five'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",99.0,0.456136,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA. mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Lee C', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Wilkinson', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0256-5']
502,30413383,Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials.,"BACKGROUND


Individual patient data from two randomised trials comparing neoadjuvant chemotherapy with upfront debulking surgery in advanced tubo-ovarian cancer were analysed to examine long-term outcomes for patients and to identify any preferable therapeutic approaches for subgroup populations.
METHODS


We did a per-protocol pooled analysis of individual patient data from the European Organisation for Research and Treatment of Cancer (EORTC) 55971 trial (NCT00003636) and the Medical Research Council Chemotherapy Or Upfront Surgery (CHORUS) trial (ISRCTN74802813). In the EORTC trial, eligible women had biopsy-proven International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or IV invasive epithelial tubo-ovarian carcinoma. In the CHORUS trial, inclusion criteria were similar to those of the EORTC trial, and women with apparent FIGO stage IIIA and IIIB disease were also eligible. The main aim of the pooled analysis was to show non-inferiority in overall survival with neoadjuvant chemotherapy compared with upfront debulking surgery, using the reverse Kaplan-Meier method. Tests for heterogeneity were based on Cochran's Q heterogeneity statistic.
FINDINGS


Data for 1220 women were included in the pooled analysis, 670 from the EORTC trial and 550 from the CHORUS trial. 612 women were randomly allocated to receive upfront debulking surgery and 608 to receive neoadjuvant chemotherapy. Median follow-up was 7·6 years (IQR 6·0-9·6; EORTC, 9·2 years [IQR 7·3-10·4]; CHORUS, 5·9 years [IQR 4·3-7·4]). Median age was 63 years (IQR 56-71) and median size of the largest metastatic tumour at diagnosis was 8 cm (IQR 4·8-13·0). 55 (5%) women had FIGO stage II-IIIB disease, 831 (68%) had stage IIIC disease, and 230 (19%) had stage IV disease, with staging data missing for 104 (9%) women. In the entire population, no difference in median overall survival was noted between patients who underwent neoadjuvant chemotherapy and upfront debulking surgery (27·6 months [IQR 14·1-51·3] and 26·9 months [12·7-50·1], respectively; hazard ratio [HR] 0·97, 95% CI 0·86-1·09; p=0·586). Median overall survival for EORTC and CHORUS patients was significantly different at 30·2 months (IQR 15·7-53·7) and 23·6 months (10·5-46·9), respectively (HR 1·20, 95% CI 1·06-1·36; p=0·004), but was not heterogeneous (Cochran's Q, p=0·17). Women with stage IV disease had significantly better outcomes with neoadjuvant chemotherapy compared with upfront debulking surgery (median overall survival 24·3 months [IQR 14·1-47·6] and 21·2 months [10·0-36·4], respectively; HR 0·76, 95% CI 0·58-1·00; p=0·048; median progression-free survival 10·6 months [7·9-15·0] and 9·7 months [5·2-13·2], respectively; HR 0·77, 95% CI 0·59-1·00; p=0·049).
INTERPRETATION


Long-term follow-up data substantiate previous results showing that neoadjuvant chemotherapy and upfront debulking surgery result in similar overall survival in advanced tubo-ovarian cancer, with better survival in women with stage IV disease with neoadjuvant chemotherapy. This pooled analysis, with long-term follow-up, shows that neoadjuvant chemotherapy is a valuable treatment option for patients with stage IIIC-IV tubo-ovarian cancer, particularly in patients with a high tumour burden at presentation or poor performance status.
FUNDING


National Cancer Institute and Vlaamse Liga tegen kanker (Flemish League against Cancer).",2018,"In the entire population, no difference in median overall survival was noted between patients who underwent neoadjuvant chemotherapy and upfront debulking surgery (27·6 months [IQR 14·1-51·3] and 26·9 months [12·7-50·1], respectively; hazard ratio [HR] 0·97, 95% CI 0·86-1·09; p=0·586).","['women with stage IV disease with neoadjuvant chemotherapy', 'advanced tubo-ovarian cancers', 'advanced tubo-ovarian cancer', '612 women', 'patients with stage IIIC-IV tubo-ovarian cancer, particularly in patients with a high tumour burden at presentation or poor performance status', '1220 women were included in the pooled analysis, 670 from the EORTC trial and 550 from the CHORUS trial', 'Median age was 63 years (IQR 56-71) and median size of the largest metastatic tumour at diagnosis was 8 cm (IQR 4·8-13·0', 'eligible women had biopsy-proven International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or IV invasive epithelial tubo-ovarian carcinoma']","['neoadjuvant chemotherapy with upfront debulking surgery', 'Neoadjuvant chemotherapy versus debulking surgery', 'neoadjuvant chemotherapy', 'upfront debulking surgery and 608 to receive neoadjuvant chemotherapy', 'neoadjuvant chemotherapy and upfront debulking surgery', 'Medical Research Council Chemotherapy Or Upfront Surgery (CHORUS) trial ']","['FIGO stage II-IIIB disease', 'Cancer (EORTC', 'stage IIIC disease', 'median progression-free survival', 'stage IV disease', 'median overall survival', 'Median overall survival', 'overall survival']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0456917', 'cui_str': 'Tubo-ovarian (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517834', 'cui_str': '612 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1706406', 'cui_str': 'Interventional debulking surgery (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}]","[{'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",612.0,0.599919,"In the entire population, no difference in median overall survival was noted between patients who underwent neoadjuvant chemotherapy and upfront debulking surgery (27·6 months [IQR 14·1-51·3] and 26·9 months [12·7-50·1], respectively; hazard ratio [HR] 0·97, 95% CI 0·86-1·09; p=0·586).","[{'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'University Hospitals Leuven, Department of Obstetrics and Gynaecology, Leuven, Belgium. Electronic address: Ignace.vergote@uzleuven.be.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Gynecological Cancer Group, Brussels, Belgium.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nankivell', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Gunnar B', 'Initials': 'GB', 'LastName': 'Kristensen', 'Affiliation': 'Norwegian Radium Hospital and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'Institute of Clinical Trials and Methodology, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Ehlen', 'Affiliation': 'Department of Gynecologic Oncology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Gordon C', 'Initials': 'GC', 'LastName': 'Jayson', 'Affiliation': 'Department of Medical Oncology, Christie Hospital and University of Manchester, Manchester, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': 'Department of Gynecologic Oncology, Royal United Hospitals Bath, Bath, UK.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Swart', 'Affiliation': 'Norwich Clinical Trials Unit and Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Verheijen', 'Affiliation': 'Department of Gynecological Oncology, Vrije Universiteit Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'W Glenn', 'Initials': 'WG', 'LastName': 'McCluggage', 'Affiliation': ""Department of Pathology, Queen's University, Belfast Health and Social Care Trust, Belfast, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Perren', 'Affiliation': ""Institute of Cancer and Pathology, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Pierluigi Benedetti', 'Initials': 'PB', 'LastName': 'Panici', 'Affiliation': 'Department of Gynecology-Obstetrics, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Kenter', 'Affiliation': 'Department of Gynecological Oncology, Center Gynaecologic Oncology Amsterdam, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Casado', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario San Carlos, Madrid, Spain.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Mendiola', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Doce de Octubre, Madrid, Spain.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Stuart', 'Affiliation': 'Department of Gynecologic Oncology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Nick S', 'Initials': 'NS', 'LastName': 'Reed', 'Affiliation': 'Department of Clinical Oncology, Beatson Oncology Centre, Glasgow, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Kehoe', 'Affiliation': 'Department of Gynaecological Cancer, University of Birmingham, Birmingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30566-7']
503,30264293,"E6201, an intravenous MEK1 inhibitor, achieves an exceptional response in BRAF V600E-mutated metastatic malignant melanoma with brain metastases.","Malignant melanoma (MM) exhibits a high propensity for central nervous system dissemination with ~50% of metastatic MM patients developing brain metastases (BM). Targeted therapies and immune checkpoint inhibitors have improved overall survival for MM patients with BM. However, responses are usually of short duration and new agents that effectively penetrate the blood brain barrier (BBB) are needed. Here, we report a MM patient with BM who experienced an exceptional response to E6201, an ATP-competitive MEK1 inhibitor, on a Phase 1 study, with ongoing near-complete response and overall survival extending beyond 8 years. Whole exome and transcriptome sequencing revealed a high mutational burden tumor (22 mutations/Megabase) with homozygous BRAF V600E mutation. Correlative preclinical studies demonstrated broad activity for E6201 across BRAF V600E mutant melanoma cell lines and effective BBB penetration in vivo. Together, these results suggest that E6201 may represent a potential new treatment option for BRAF-mutant MM patients with BM.",2019,Correlative preclinical studies demonstrated broad activity for E6201 across BRAF V600E mutant melanoma cell lines and effective BBB penetration in vivo.,"['MM patients with BM', 'BRAF-mutant MM patients with BM']",[],"['blood brain barrier (BBB', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0005854', 'cui_str': 'Hemato-Encephalic Barrier'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.115159,Correlative preclinical studies demonstrated broad activity for E6201 across BRAF V600E mutant melanoma cell lines and effective BBB penetration in vivo.,"[{'ForeName': 'Hani M', 'Initials': 'HM', 'LastName': 'Babiker', 'Affiliation': 'Early Phase Clinical Trials Program, University of Arizona Cancer Center, 1515 N. Campbell Ave, Tucson, AZ, 85724, USA. hanibabiker@email.arizona.edu.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Byron', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'William P D', 'Initials': 'WPD', 'LastName': 'Hendricks', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Elmquist', 'Affiliation': 'Department of Pharmaceutics, University of Minnesota, 308 SE Harvard Street, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Gautham', 'Initials': 'G', 'LastName': 'Gampa', 'Affiliation': 'Department of Pharmaceutics, University of Minnesota, 308 SE Harvard Street, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vondrak', 'Affiliation': 'Early Phase Clinical Trials Program, University of Arizona Cancer Center, 1515 N. Campbell Ave, Tucson, AZ, 85724, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Aldrich', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Cuyugan', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Adkins', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'De Luca', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Tibes', 'Affiliation': 'Honor Health Research Institute, 10510 N. 92nd Street, #200, Scottsdale, AZ, 85258, USA.'}, {'ForeName': 'Mitesh J', 'Initials': 'MJ', 'LastName': 'Borad', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Marceau', 'Affiliation': 'Honor Health Research Institute, 10510 N. 92nd Street, #200, Scottsdale, AZ, 85258, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Myers', 'Affiliation': 'Spirita Oncology, LLC, 2450 Holcombe Blvd., Suite J, Houston, TX, 77021, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Paradiso', 'Affiliation': 'Spirita Oncology, LLC, 2450 Holcombe Blvd., Suite J, Houston, TX, 77021, USA.'}, {'ForeName': 'Winnie S', 'Initials': 'WS', 'LastName': 'Liang', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Korn', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Cridebring', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Von Hoff', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Carpten', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Craig', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Trent', 'Affiliation': 'Translational Genomics Research Institute, 445 N. Fifth Street, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Gordon', 'Affiliation': 'Honor Health Research Institute, 10510 N. 92nd Street, #200, Scottsdale, AZ, 85258, USA.'}]",Investigational new drugs,['10.1007/s10637-018-0668-8']
504,32144438,Tripping on nothing: placebo psychedelics and contextual factors.,"RATIONALE


Is it possible to have a psychedelic experience from a placebo alone? Most psychedelic studies find few effects in the placebo control group, yet these effects may have been obscured by the study design, setting, or analysis decisions.
OBJECTIVE


We examined individual variation in placebo effects in a naturalistic environment resembling a typical psychedelic party.
METHODS


Thirty-three students completed a single-arm study ostensibly examining how a psychedelic drug affects creativity. The 4-h study took place in a group setting with music, paintings, coloured lights, and visual projections. Participants consumed a placebo that we described as a drug resembling psilocybin, which is found in psychedelic mushrooms. To boost expectations, confederates subtly acted out the stated effects of the drug and participants were led to believe that there was no placebo control group. The participants later completed the 5-Dimensional Altered States of Consciousness Rating Scale, which measures changes in conscious experience.
RESULTS


There was considerable individual variation in the placebo effects; many participants reported no changes while others showed effects with magnitudes typically associated with moderate or high doses of psilocybin. In addition, the majority (61%) of participants verbally reported some effect of the drug. Several stated that they saw the paintings on the walls ""move"" or ""reshape"" themselves, others felt ""heavy… as if gravity [had] a stronger hold"", and one had a ""come down"" before another ""wave"" hit her.
CONCLUSION


Understanding how context and expectations promote psychedelic-like effects, even without the drug, will help researchers to isolate drug effects and clinicians to maximise their therapeutic potential.",2020,There was considerable individual variation in the placebo effects; many participants reported no changes while others showed effects with magnitudes typically associated with moderate or high doses of psilocybin.,['Thirty-three students'],['placebo'],['5-Dimensional Altered States of Consciousness Rating Scale'],"[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0150450', 'cui_str': 'Altered state of consciousness'}, {'cui': 'C0222045'}]",33.0,0.156322,There was considerable individual variation in the placebo effects; many participants reported no changes while others showed effects with magnitudes typically associated with moderate or high doses of psilocybin.,"[{'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'Department of Psychiatry, McGill University, 1033 Pine Avenue West, Montreal, QC, H3A 1A1, Canada. jay.olson@mail.mcgill.ca.'}, {'ForeName': 'Léah', 'Initials': 'L', 'LastName': 'Suissa-Rocheleau', 'Affiliation': 'Department of Psychology, McGill University, 2001 Avenue McGill College, Montreal, QC, H3A 1G1, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lifshitz', 'Affiliation': 'Department of Anthropology, Stanford University, Main Quad, Building 50, 450 Serra Mall, Stanford, CA, 94305, USA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Raz', 'Affiliation': 'Department of Psychiatry, McGill University, 1033 Pine Avenue West, Montreal, QC, H3A 1A1, Canada.'}, {'ForeName': 'Samuel P L', 'Initials': 'SPL', 'LastName': 'Veissière', 'Affiliation': 'Department of Psychiatry, McGill University, 1033 Pine Avenue West, Montreal, QC, H3A 1A1, Canada.'}]",Psychopharmacology,['10.1007/s00213-020-05464-5']
505,29514333,Buprenorphine Maintenance Subjects Are Hyperalgesic and Have No Antinociceptive Response to a Very High Morphine Dose.,"Objective


Acute pain management in opioid-dependent persons is complicated because of tolerance and opioid-induced hyperalgesia. Very high doses of morphine are ineffective in overcoming opioid-induced hyperalgesia and providing antinociception to methadone-maintained patients in an experimental setting. Whether the same occurs in buprenorphine-maintained subjects is unknown.
Design


Randomized double-blind placebo-controlled. Subjects were tested on two occasions, at least five days apart, once with intravenous morphine and once with intravenous saline. Subjects were tested at about the time of putative trough plasma buprenorphine concentrations.
Setting


Ambulatory.
Subjects


Twelve buprenorphine-maintained subjects: once daily sublingual dose (range = 2-22 mg); no dose change for 1.5-12 months. Ten healthy controls.
Methods


Intravenous morphine bolus and infusions administered over two hours to achieve two separate pseudo-steady-state plasma concentrations one hour apart. Pain tolerance was assessed by application of nociceptive stimuli (cold pressor [seconds] and electrical stimulation [volts]). Ten blood samples were collected for assay of plasma morphine, buprenorphine, and norbuprenorphine concentrations until three hours after the end of the last infusion; pain tolerance and respiration rate were measured to coincide with blood sampling times.
Results


Cold pressor responses (seconds): baseline: control 34 ± 6 vs buprenorphine 17 ± 2 (P = 0.009); morphine infusion-end: control 52 ± 11(P = 0.04), buprenorphine 17 ± 2 (P > 0.5); electrical stimulation responses (volts): baseline: control 65 ± 6 vs buprenorphine 53 ± 5 (P = 0.13); infusion-end: control 74 ± 5 (P = 0.007), buprenorphine 53 ± 5 (P > 0.98). Respiratory rate (breaths per minute): baseline: control 17 vs buprenorphine 14 (P = 0.03); infusion-end: control 15 (P = 0.09), buprenorphine 12 (P < 0.01). Infusion-end plasma morphine concentrations (ng/mL): control 23 ± 1, buprenorphine 136 ± 10.
Conclusions


Buprenorphine subjects, compared with controls, were hyperalgesic (cold pressor test), did not experience antinociception, despite high plasma morphine concentrations, and experienced respiratory depression. Clinical implications are discussed.",2019,"Respiratory rate (breaths per minute): baseline: control 17 vs buprenorphine 14 (P = 0.03); infusion-end: control 15 (P = 0.09), buprenorphine 12 (P < 0.01).",['Ten healthy controls'],"['placebo', 'buprenorphine-maintained subjects: once daily sublingual', 'Infusion-end plasma morphine concentrations (ng/mL): control 23\u2009±\u20091, buprenorphine 136\u2009±\u200910', 'morphine', 'buprenorphine', 'morphine and once with intravenous saline', 'Buprenorphine']","['nociceptive stimuli (cold pressor [seconds] and electrical stimulation [volts', 'plasma morphine concentrations, and experienced respiratory depression', 'plasma morphine, buprenorphine, and norbuprenorphine concentrations', 'Respiratory rate', 'pain tolerance and respiration rate', 'Pain tolerance', 'electrical stimulation responses']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0439502', 'cui_str': 'V - volt'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0068965', 'cui_str': 'norbuprenorphine'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}]",10.0,0.0788052,"Respiratory rate (breaths per minute): baseline: control 17 vs buprenorphine 14 (P = 0.03); infusion-end: control 15 (P = 0.09), buprenorphine 12 (P < 0.01).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Athanasos', 'Affiliation': 'Discipline of Psychiatry, Flinders University, Bedford Park, Australia.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Integrated Substance Abuse Programs, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bochner', 'Affiliation': 'Discipline of Pharmacology, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'White', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Somogyi', 'Affiliation': 'Discipline of Pharmacology, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, Australia.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny025']
506,29489078,Sluggish Cognitive Tempo as a Possible Predictor of Methylphenidate Response in Children With ADHD: A Randomized Controlled Trial.,"OBJECTIVE


To examine whether sluggish cognitive tempo (SCT) symptomatology moderates dose response to methylphenidate and whether the impact of SCT on medication response is distinct from attention-deficit/hyperactivity disorder (ADHD) subtype effects.
METHODS


Stimulant-naive children with ADHD predominantly inattentive type (ADHD-I; n = 126) or ADHD combined type (ADHD-C; n = 45) aged 7-11 years were recruited from the community from September 2006 to June 2013 to participate in a prospective, randomized, double-blind, 4-week crossover trial of long-acting methylphenidate. ADHD diagnosis and subtype were established according to DSM-IV criteria using a structured interview and teacher ADHD symptom ratings. SCT symptoms were assessed using a teacher-rated scale with 2 factors (Sluggish/Sleepy and Daydreamy). Primary outcomes included (1) categorization of children as methylphenidate responders, methylphenidate nonresponders, or placebo responders by 2 blinded physicians and (2) parent and teacher ratings of child behavior on the Vanderbilt ADHD Diagnostic Rating Scales while subjects were on treatment with placebo or 1 of 3 methylphenidate dosages (low, medium, high).
RESULTS


Increased SCT Sluggish/Sleepy factor scores were associated with being a methylphenidate nonresponder or placebo responder rather than a methylphenidate responder (P = .04). Sluggish/Sleepy factor scores were also linked to diminished methylphenidate dose response for parent- and teacher-rated inattention symptoms (Sluggish/Sleepy factor × dose P = .004). SCT Daydreamy symptoms and ADHD subtype (ADHD-I vs ADHD-C) were not associated with methylphenidate responder status and did not moderate methylphenidate dose response for inattention symptoms.
CONCLUSIONS


SCT Sluggish/Sleepy symptoms, but not SCT Daydreamy symptoms or ADHD subtype, predicted methylphenidate nonresponse. This novel finding, if replicated, may have important implications for assessing SCT as part of ADHD care.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01727414.",2018,Sluggish/Sleepy factor scores were associated with being a methylphenidate nonresponder or placebo responder rather than a methylphenidate responder (P = .04).,"['ADHD-I; n = 126) or ADHD combined type (ADHD-C; n = 45) aged 7-11 years were recruited from the community from September 2006 to June 2013 to participate', 'Children With ADHD', 'Stimulant-naive children with ADHD predominantly inattentive type']","['SCT', 'methylphenidate', 'placebo']","['1) categorization of children as methylphenidate responders, methylphenidate nonresponders, or placebo responders by 2 blinded physicians and (2) parent and teacher ratings of child behavior on the Vanderbilt ADHD Diagnostic Rating Scales', 'methylphenidate dose response for parent- and teacher-rated inattention symptoms', 'Sluggish/Sleepy factor scores', 'SCT symptoms', 'SCT Daydreamy symptoms and ADHD subtype']","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0222045'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0424101', 'cui_str': 'Inattention (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}]",45.0,0.404474,Sluggish/Sleepy factor scores were associated with being a methylphenidate nonresponder or placebo responder rather than a methylphenidate responder (P = .04).,"[{'ForeName': 'Tanya E', 'Initials': 'TE', 'LastName': 'Froehlich', 'Affiliation': ""Cincinnati Children's Hospital, 3333 Burnet Ave, MLC 4002, Cincinnati, OH 45229. tanya.froehlich@cchmc.org.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Becker', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Todd G', 'Initials': 'TG', 'LastName': 'Nick', 'Affiliation': 'Department of Pediatrics, University of Arkansas for Medical Sciences, College of Medicine, Little Rock, Arkansas, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Brinkman', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Stein', 'Affiliation': ""Departments of Psychiatry and Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, Washington, USA.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peugh', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jeffery N', 'Initials': 'JN', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.17m11553']
507,31962052,Virtual Reality Relaxation to Decrease Dental Anxiety: Immediate Effect Randomized Clinical Trial.,"INTRODUCTION


Dental anxiety is common and causes symptomatic use of oral health services.
OBJECTIVES


The aim was to study if a short-term virtual reality intervention reduced preoperative dental anxiety.
METHODS


A randomized controlled single-center trial was conducted with 2 parallel arms in a public oral health care unit: virtual reality relaxation (VRR) and treatment as usual (TAU). The VRR group received a 1- to 3.5-min 360° immersion video of a peaceful virtual landscape with audio features and sound supporting the experience. TAU groups remained seated for 3 min. Of the powered sample of 280 participants, 255 consented and had complete data. Total and secondary sex-specific mixed effects linear regression models were completed for posttest dental anxiety (Modified Dental Anxiety Scale [MDAS] total score) and its 2 factors (anticipatory and treatment-related dental anxiety) adjusted for baseline (pretest) MDAS total and factor scores and age, taking into account the effect of blocking.
RESULTS


Total and anticipatory dental anxiety decreased more in the VRR group than the TAU group (β = -0.75, P < .001, for MDAS total score; β = -0.43, P < .001, for anticipatory anxiety score) in patients of a primary dental care clinic. In women, dental anxiety decreased more in VRR than TAU for total MDAS score (β = -1.08, P < .001) and treatment-related dental anxiety (β = -0.597, P = .011). Anticipatory dental anxiety decreased more in VRR than TAU in both men (β = -0.217, P < .026) and women (β = -0.498, P < .001).
CONCLUSION


Short application of VRR is both feasible and effective to reduce preoperative dental anxiety in public dental care settings (ClinicalTrials.gov NCT03993080).
KNOWLEDGE TRANSFER STATEMENT


Dental anxiety, which is a common problem, can be reduced with short application of virtual reality relaxation applied preoperatively in the waiting room. Findings of this study indicate that it is a feasible and effective procedure to help patients with dental anxiety in normal public dental care settings.",2020,"Short application of VRR is both feasible and effective to reduce preoperative dental anxiety in public dental care settings (ClinicalTrials.gov NCT03993080).
","['280 participants, 255 consented and had complete data', 'patients with dental anxiety in normal public dental care settings']","['VRR', 'virtual reality intervention', 'Virtual Reality Relaxation', 'public oral health care unit: virtual reality relaxation (VRR) and treatment as usual (TAU']","['Total and anticipatory dental anxiety', 'dental anxiety', 'Anticipatory dental anxiety', 'MDAS total and factor scores', 'MDAS total score', 'anticipatory anxiety score', 'posttest dental anxiety (Modified Dental Anxiety Scale [MDAS] total score) and its 2 factors (anticipatory and treatment-related dental anxiety) adjusted for baseline (pretest', 'Dental Anxiety', 'total MDAS score']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0029162'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]",280.0,0.082385,"Short application of VRR is both feasible and effective to reduce preoperative dental anxiety in public dental care settings (ClinicalTrials.gov NCT03993080).
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lahti', 'Affiliation': 'Department of Community Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Suominen', 'Affiliation': 'Department of Community Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Dental Health Services Research Unit, School of Dentistry, University of Dundee, Dundee, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lähteenoja', 'Affiliation': 'Department of Community Dentistry, University of Turku, Turku, Finland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Humphris', 'Affiliation': 'Division of Populations and Behavioural Science, School of Medicine, University of St Andrews, St Andrews, UK.'}]",JDR clinical and translational research,['10.1177/2380084420901679']
508,31369674,"Efficacy and Safety of Acupuncture for Chronic Discogenic Sciatica, a Randomized Controlled Sham Acupuncture Trial.","OBJECTIVE


To evaluate the efficacy and safety of acupuncture for discogenic sciatica.
DESIGN


Single-center, parallel, randomized controlled sham acupuncture trial.
METHODS


Twelve sessions of acupuncture or sham acupuncture at the same traditional acupoints over four weeks. The primary outcome was change from baseline in weekly mean leg pain, measured by the visual analog scale (VAS) over the four-week treatment period. The secondary outcomes were determined by the change from baseline in mean VAS scores for leg pain, VAS scores for low back pain, Oswestry Disability Index (ODI) scores, and 36-Item Short Form Health Survey (SF-36) scores. Patients were followed for 28 weeks.
RESULTS


Forty-six patients were enrolled in this study between June 2017 and January 2018, of which 23 were in the acupuncture group and 23 were in the sham acupuncture group. The between-group difference in weekly mean leg pain measured by the VAS over the four-week treatment period was -7.28 mm (95% confidence interval = -13.76 to -0.80, P = 0.029), which is larger than the minimum clinically important difference of 5 mm. The between-group differences in mean VAS scores for low back pain, ODI scores, and SF-36 scores were not significant in the study period (P > 0.05 for all). The proportion of acupuncture-related adverse events was 4.3%, and all adverse events were mild and transient.
CONCLUSIONS


Twelve sessions of acupuncture showed short-term clinical benefits in relieving the symptoms of leg pain for patients with chronic discogenic sciatica compared with sham acupuncture. Acupuncture is safe in treating chronic discogenic sciatica. Further studies with larger sample sizes, a longer treatment period, and long-term follow-up should be conducted to verify these results.",2019,"The between-group differences in mean VAS scores for low back pain, ODI scores, and SF-36 scores were not significant in the study period (P > 0.05 for all).","['Chronic Discogenic Sciatica', 'Forty-six patients were enrolled in this study between June 2017 and January 2018, of which 23 were in the acupuncture group and 23 were in the sham acupuncture group', 'patients with chronic discogenic sciatica']","['acupuncture', 'acupuncture or sham acupuncture', 'sham acupuncture', 'Acupuncture']","['leg pain', 'weekly mean leg pain', 'proportion of acupuncture-related adverse events', 'mean VAS scores for low back pain, ODI scores, and SF-36 scores', 'efficacy and safety', 'mean VAS scores for leg pain, VAS scores for low back pain, Oswestry Disability Index (ODI) scores, and 36-Item Short Form Health Survey (SF-36) scores', 'change from baseline in weekly mean leg pain, measured by the visual analog scale (VAS', 'Efficacy and Safety']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0036396', 'cui_str': 'Sciatic Neuralgia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score (observable entity)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",46.0,0.255088,"The between-group differences in mean VAS scores for low back pain, ODI scores, and SF-36 scores were not significant in the study period (P > 0.05 for all).","[{'ForeName': 'Ziling', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Sixing', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz167']
509,31964579,"Effects of an educational intervention on heart failure knowledge, self-care behaviors, and health-related quality of life of patients with heart failure: Exploring the role of depression.","OBJECTIVES


To test effects of an educational intervention on patient-reported outcomes among rural heart failure (HF) patients and to examine whether effects differed between patients with and without depression.
METHODS


Patients (N = 614) were randomized to usual care (UC) or 1 of 2 intervention groups. Both intervention groups received face-to-face education, followed by either 2 phone calls (LITE) or biweekly calls until they demonstrated content competency (PLUS). Follow-up lasted 24 months. Statistical analyses included linear mixed models and subgroup analyses by depression status.
RESULTS


Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001). Improvement lasted 24 months only in the PLUS group. Compared to UC, both intervention groups exhibited better self-care at 3 months (LITE-UC, p < 0.001; PLUS-UC, p < 0.001) and 12 months (LITE-UC, p = 0.001; PLUS-UC, p = 0.002). There were no differences in health-related quality of life (HRQOL) among groups. In subgroup analyses, similar effects were found among non-depressed, but not among depressed patients.
CONCLUSION


The educational intervention improved HF knowledge and self-care, but not HRQOL. No intervention effects were observed in patients with depressive symptoms.
PRACTICE IMPLICATIONS


The simple educational intervention is promising to improve HF knowledge and self-care. Additional strategies are needed for depressed patients.",2020,"Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001).","['Patients (N\u202f=\u202f614', 'rural heart failure (HF) patients', 'patients with depressive symptoms', 'patients with and without depression', 'patients with heart failure']","['face-to-face education, followed by either 2 phone calls (LITE) or biweekly calls until they demonstrated content competency (PLUS', 'usual care (UC', 'educational intervention']","['HF knowledge', 'HF knowledge and self-care', 'health-related quality of life (HRQOL', 'heart failure knowledge, self-care behaviors, and health-related quality of life', 'self-care']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior (finding)'}]",614.0,0.0257365,"Both intervention groups showed improvement in HF knowledge at 3 months (LITE-UC, p = 0.003; PLUS-UC, p < 0.001).","[{'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Hwang', 'Affiliation': 'College of Nursing & Research Institute of Nursing Science, Seoul National University, Seoul, Republic of Korea. Electronic address: bhwang@snu.ac.kr.'}, {'ForeName': 'Michele M', 'Initials': 'MM', 'LastName': 'Pelter', 'Affiliation': 'School of Nursing, University of California, San Francisco, USA.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Moser', 'Affiliation': 'College of Nursing, University of Kentucky, Lexington, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Dracup', 'Affiliation': 'School of Nursing, University of California, San Francisco, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.01.007']
510,31965170,Sensitivity of the Nipple-Areola Complex in Reduction Mammaplasty Following Periareolar Dermis Section.,"BACKGROUND


Preservation of the periareolar dermis, after de-epithelization in reduction mammaplasty, may result in reduced nipple-areola complex (NAC) mobility. Consequently, distortion in shape and difficulty correcting the areola position can occur.
OBJECTIVES


The aim of this study was to evaluate NAC viability and sensitivity resulting from periareolar dermis section after de-epithelization in patients who underwent reduction mammaplasty surgery.
METHODS


This study was a randomized, controlled double-blind clinical trial. A total of 41 patients (82 breasts) were randomly allocated into 2 groups and underwent reduction mammaplasty-involving the superior pedicle-with a final inverted T-shaped scar. A sectioning of the periareolar dermis was performed on the breasts in the experimental group. Semmes-Weinstein monofilaments were used to evaluate NAC sensitivity at the preoperative evaluation, and 3, 6, and 52 weeks after surgery.
RESULTS


No cases of partial or total NAC necrosis were noted in either group. The comparison between the groups did not show significant differences regarding NAC sensitivity. However, a statistically significant difference was noted when sensitivity levels at the preoperative evaluation and 3 weeks after surgery were compared in the experimental group. A significant difference was noted when the scores of the sensitivity 3 weeks after surgery were compared between the control and the experiment groups. Nevertheless, after 1 year, no statistical differences were observed in the experimental group or between both groups.
CONCLUSIONS


The sectioning of the periareolar dermis does not affect the viability or the pressure sensitivity of the NAC.
LEVEL OF EVIDENCE: 4


",2020,A significant difference was noted when the scores of the sensitivity three weeks after surgery were compared between the control and the experiment groups.,"['patients who underwent reduction mammaplasty surgery', '41 patients (82 breasts']",['reduction mammaplasty - using the superior pedicle - with a final inverted T-shaped scar'],"['NAC sensitivity', 'partial or total NAC necrosis', 'sensitivity levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0191922', 'cui_str': 'Breast reduction'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]","[{'cui': 'C0191922', 'cui_str': 'Breast reduction'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0456605', 'cui_str': 'Pedicle (substance)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439636', 'cui_str': 'Inverted-T (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",41.0,0.0269908,A significant difference was noted when the scores of the sensitivity three weeks after surgery were compared between the control and the experiment groups.,"[{'ForeName': 'Jairo Zacchê', 'Initials': 'JZ', 'LastName': 'de Sá', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Antônio Carlos Côrte Real', 'Initials': 'ACCR', 'LastName': 'Braga', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Rafael Henrique Coutinho', 'Initials': 'RHC', 'LastName': 'Barreto', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Anderson da Silva', 'Initials': 'ADS', 'LastName': 'Ramos', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Amanda Estelita', 'Initials': 'AE', 'LastName': 'de Oliveira Rodrigues', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Santa-Cruz', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'José Lamartine de Andrade', 'Initials': 'JLA', 'LastName': 'Aguiar', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa011']
511,30649458,Opioid-Induced Reductions in Gait Variability in Healthy Volunteers and Individuals with Knee Osteoarthritis.,"OBJECTIVE


To investigate differences in gait variability induced by two different single-dose opioid formulations and an inert placebo in healthy volunteers and knee osteoarthritis patients.
DESIGN


Experimental, randomized, double-blinded, crossover study of inert placebo (calcium tablets), 50 mg of tapentadol, and 100 mg of tramadol.
SETTING


Laboratory setting.
SUBJECTS


Healthy volunteers and knee osteoarthritis patients.
METHODS


At three visits, separated by seven days, one tablet was administered per visit according to the randomization code. At each visit, a baseline measurement was done before tablet administration, after which hourly measurements were performed for six hours, yielding a total of seven measurements per visit. Gait variability was measured by three-dimensional gait analysis, recorded during six minutes of continuous treadmill walking at self-selected speed. One hundred seventy gait cycles were identified from detection of clear events of the knee joint angle trajectories. Gait variability was assessed as average standard deviations over a gait cycle of the sacrum displacements and accelerations; sagittal plane ankle, knee, and hip joint angles; step widths; and stride times.
RESULTS


Twenty-four opioid-naïve and neurologically intact participants (12 healthy volunteers and 12 knee osteoarthritis patients) were included and completed the experiment. Tapentadol reduced the variability of sacrum displacements and accelerations compared with placebo and tramadol. There were no differences between experimental conditions regarding the variability in lower-extremity joint angle variability, step widths, or stride times.
CONCLUSIONS


In opioid-naïve and neurologically intact individuals, tapentadol seems to reduce movement variability during treadmill walking, compared with placebo and tramadol. This can be interpreted as a loss of adaptability that might increase the risk of falling if the system is perturbed.",2019,"There were no differences between experimental conditions regarding the variability in lower-extremity joint angle variability, step widths, or stride times.
","['Results\n\n\nTwenty-four opioid-naïve and neurologically intact participants (12 healthy volunteers and 12 knee osteoarthritis patients', 'Healthy Volunteers and Individuals with Knee Osteoarthritis', 'healthy volunteers and knee osteoarthritis patients', 'Subjects\n\n\nHealthy volunteers and knee osteoarthritis patients', 'One hundred seventy gait cycles']","['tramadol', 'placebo', 'inert placebo (calcium tablets), 50\u2009mg of tapentadol, and 100\u2009mg of tramadol', 'Tapentadol', 'placebo and tramadol']","['lower-extremity joint angle variability, step widths, or stride times', 'Gait variability', 'Gait Variability', 'average standard deviations over a gait cycle of the sacrum displacements and accelerations; sagittal plane ankle, knee, and hip joint angles; step widths; and stride times', 'gait variability', 'variability of sacrum displacements and accelerations']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C2001271', 'cui_str': 'tapentadol'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0036037', 'cui_str': 'Sacrum'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0019558', 'cui_str': 'Acetabulofemoral Joint'}]",12.0,0.256567,"There were no differences between experimental conditions regarding the variability in lower-extremity joint angle variability, step widths, or stride times.
","[{'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Henriksen', 'Affiliation': 'The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Copenhagen, Denmark.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Alkjær', 'Affiliation': 'Department of Physical and Occupational Therapy, Copenhagen University Hospital Bispebjerg-Frederiksberg, Copenhagen, Denmark.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Raffalt', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Louse', 'Initials': 'L', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Bartholdy', 'Affiliation': 'The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Copenhagen, Denmark.'}, {'ForeName': 'Steen Honoré', 'Initials': 'SH', 'LastName': 'Hansen', 'Affiliation': 'Analytical Biosciences, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bliddal', 'Affiliation': 'The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Copenhagen, Denmark.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny286']
512,31984445,"A randomized, placebo-controlled laboratory study of the effects of D-cycloserine on sexual memory consolidation in women.","RATIONALE AND OBJECTIVE


The aim of this study was to investigate the possible facilitating effect of the partial NMDA receptor agonist D-cycloserine (DCS) on memory consolidation of conditioned sexual responses and to examine the capability of DCS to reduce context-specificity of learning.
METHODS


In a randomized placebo-controlled double-blind trial, 50 healthy females were exposed to a differential conditioning procedure. Two pictures of a male abdomen were used as conditional stimuli (CSs), of which one (the CS+) was followed by the unconditional stimulus (US), a genital vibrotactile stimulus. After the conditioning session on day 1, participants received either 125 mg of DCS or a placebo. The effects of DCS on affect, sexual arousal and US expectancy in response to the CS+ and CS- were examined 24 h after the conditioning procedure.
RESULTS


A main effect of DCS was found on affect at the first test trials (p = 0.04, η p 2  = 0.09), and a similar non-significant but trend level effect was found for sexual arousal (p = 0.06, η p 2  = 0.07), which appeared to persist over a longer time (p = 0.07, η p 2  = 0.08). Unexpectedly, ratings of positive affect and sexual arousal in response to both the CS+ and the CS- were higher in the DCS condition compared to the control condition, possibly indicating that DCS administration reduced stimulus specificity. Since the results did not show clear evidence for context learning, we were not able to test effects on context-specificity of learning.
CONCLUSION


Although largely inconclusive, the results provide tentative support for a facilitating effect of DCS on affect and sexual arousal in response to stimuli that were presented in a sexual conditioning procedure, however, no conclusions can be drawn about effects of DCS on sexual reward learning, since the design and results do not lend themselves to unambiguous interpretation.",2020,"A main effect of DCS was found on affect at the first test trials (p = 0.04, η p 2  = 0.09), and a similar non-significant but trend level effect was found for sexual arousal (p = 0.06, η p 2  = 0.07), which appeared to persist over a longer time (p = 0.07, η p 2  = 0.08).","['women', '50 healthy females']","['partial NMDA receptor agonist D-cycloserine (DCS', 'placebo', 'DCS', 'D-cycloserine', '125\xa0mg of DCS']","['ratings of positive affect and sexual arousal', 'sexual arousal', 'stimulus specificity', 'sexual memory consolidation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0233972', 'cui_str': 'Sexual excitation, function (observable entity)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}]",50.0,0.213387,"A main effect of DCS was found on affect at the first test trials (p = 0.04, η p 2  = 0.09), and a similar non-significant but trend level effect was found for sexual arousal (p = 0.06, η p 2  = 0.07), which appeared to persist over a longer time (p = 0.07, η p 2  = 0.08).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Both', 'Affiliation': 'Department of Psychosomatic Gynecology and Sexology, Leiden University Medical Center, Poortgebouw-Zuid, 4e etage, Rijnsburgerweg 10, 2333 AA, Leiden, The Netherlands. s.both@lumc.nl.'}, {'ForeName': 'R J B', 'Initials': 'RJB', 'LastName': 'Van Veen', 'Affiliation': 'Department of Psychosomatic Gynecology and Sexology, Leiden University Medical Center, Poortgebouw-Zuid, 4e etage, Rijnsburgerweg 10, 2333 AA, Leiden, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brom', 'Affiliation': 'Department of Psychosomatic Gynecology and Sexology, Leiden University Medical Center, Poortgebouw-Zuid, 4e etage, Rijnsburgerweg 10, 2333 AA, Leiden, The Netherlands.'}, {'ForeName': 'P T M', 'Initials': 'PTM', 'LastName': 'Weijenborg', 'Affiliation': 'Department of Psychosomatic Gynecology and Sexology, Leiden University Medical Center, Poortgebouw-Zuid, 4e etage, Rijnsburgerweg 10, 2333 AA, Leiden, The Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05457-4']
513,31983177,"Efficacy and Safety of Metronomic Chemotherapy Versus Palliative Hydroxyurea in Unfit Acute Myeloid Leukemia Patients: A Multicenter, Open-Label Randomized Controlled Trial.","BACKGROUND


Management of unfit AML patients is a therapeutic challenge. Most hematologists tend to avoid aggressive treatment leaving patients with a choice of best supportive care. We hypothesized that metronomic chemotherapy could be an alternative treatment for unfit AML patients.
METHODS


A multi-center randomized controlled trial was conducted in seven university-affiliated hospitals in Thailand. Unfit AML patients were recruited and followed up from December 2014 to December 2017. Patients were randomly assigned to receive either metronomic chemotherapy or palliative hydroxyurea. Overall survival rates were compared using Cox's proportional hazard survival analysis.
RESULTS


A total of 81 eligible patients were randomly allocated and included for ITT analysis. The OS rate was higher in group receiving metronomic chemotherapy than in group receiving palliative treatment at 6 and 12 months with borderline significance (6 months HR 0.60; 95%CI 0.36, 1.02; p-value 0.060; 12 months: HR 0.66; 95%CI 0.41, 1.08; p-value 0.097).
CONCLUSION


Metronomic chemotherapy could prolong survival time of unfit AML patients, especially in the first 12 months after diagnosis without increasing treatment-associated adverse events.",2020,"The OS rate was higher in group receiving metronomic chemotherapy than in group receiving palliative treatment at 6 and 12 months with borderline significance (6 months HR 0.60; 95%CI 0.36, 1.02; p-value 0.060; 12 months: HR 0.66; 95%CI 0.41, 1.08; p-value 0.097).
","['seven university-affiliated hospitals in Thailand', 'unfit AML patients', 'Unfit Acute Myeloid Leukemia Patients', 'Unfit AML patients were recruited and followed up from December 2014 to December 2017', 'A total of 81 eligible patients']","['metronomic chemotherapy or palliative hydroxyurea', 'Metronomic Chemotherapy Versus Palliative Hydroxyurea', 'metronomic chemotherapy', 'Metronomic chemotherapy']","['OS rate', 'survival time', 'Overall survival rates', 'Efficacy and Safety']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]","[{'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",81.0,0.201944,"The OS rate was higher in group receiving metronomic chemotherapy than in group receiving palliative treatment at 6 and 12 months with borderline significance (6 months HR 0.60; 95%CI 0.36, 1.02; p-value 0.060; 12 months: HR 0.66; 95%CI 0.41, 1.08; p-value 0.097).
","[{'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Pongudom', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Udon Thani Hospital, Udon Thani, Thailand.'}, {'ForeName': 'Phichayut', 'Initials': 'P', 'LastName': 'Phinyo', 'Affiliation': 'Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Yingyong', 'Initials': 'Y', 'LastName': 'Chinthammitr', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Kanyaporn', 'Initials': 'K', 'LastName': 'Charoenprasert', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Si Sa Ket Hospital, Si Sa Ket, Thailand.'}, {'ForeName': 'Harutaya', 'Initials': 'H', 'LastName': 'Kasyanan', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Buddhachinaraj, Hospital, Phitsanulok,Thailand.'}, {'ForeName': 'Klaijith', 'Initials': 'K', 'LastName': 'Wongyai', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Sawanpracharak Hospital, Nakhon Sawan,Thailand.'}, {'ForeName': 'Jittiporn', 'Initials': 'J', 'LastName': 'Purattanamal', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Maharaj Nakhon Si Thammarat Hospital, Nakhon Si Thammarat,Thailand.'}, {'ForeName': 'Naiyana', 'Initials': 'N', 'LastName': 'Panoi', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Chonburi Hospital, Chon Buri, Thailand.'}, {'ForeName': 'Anoree', 'Initials': 'A', 'LastName': 'Surawong', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Sanprasithiprasong Hospital, Ubon Ratchathani, Thailand.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.1.147']
514,31983186,The Effect of Prostate Cancer Educational Program on the level of Knowledge and Intention to Screen among Jordanian Men in Amman.,"PURPOSE


The purpose of this study was to examine the effect of prostate cancer educational program on the level of knowledge and intention to screen for prostate cancer among Jordanian men in Amman.
METHODS


A quasi-experimental, with nonequivalent control group design was used. 154 participants were randomly assigned to the intervention and control groups.  Level of Knowledge and intention to screen were measured at baseline and at 1 month after the application of the prostate cancer educational program. Independent sample t-test was used to analyze the data.
RESULTS


The results showed statistically significant change in the mean knowledge scores (8.7), p < 0.001 and the mean of intention to screen scores (3.71), p < 0.001, after 1 month from the application of the educational program in the experimental group compared to the control group.
CONCLUSION


Implementing prostate cancer educational programs help enhance knowledge and intention to screen among Jordanian men.",2020,"The results showed statistically significant change in the mean knowledge scores (8.7), p < 0.001 and the mean of intention to screen scores (3.71), p < 0.001, after 1 month from the application of the educational program in the experimental group compared to the control group.
","['prostate cancer among Jordanian men in Amman', 'Jordanian Men in Amman', '154 participants', 'Jordanian men']","['Prostate Cancer Educational Program', 'prostate cancer educational program']","['mean knowledge scores', 'Level of Knowledge and intention to screen', 'mean of intention to screen scores', 'level of Knowledge and Intention to Screen']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",154.0,0.0187826,"The results showed statistically significant change in the mean knowledge scores (8.7), p < 0.001 and the mean of intention to screen scores (3.71), p < 0.001, after 1 month from the application of the educational program in the experimental group compared to the control group.
","[{'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Saleh', 'Affiliation': 'Prince Sattam Bin Abdulaziz University, College of Applied Medical Sciences, Department of Nursing, Alkharj, Riyadh, Saudi Arabia.'}, {'ForeName': 'Elturabi Elsayed', 'Initials': 'EE', 'LastName': 'Ebrahim', 'Affiliation': 'Prince Sattam Bin Abdulaziz University, College of Applied Medical Sciences, Department of Nursing, Alkharj, Riyadh, Saudi Arabia.'}, {'ForeName': 'Eid Hamed', 'Initials': 'EH', 'LastName': 'Aldossary', 'Affiliation': 'Prince Sattam Bin Abdulaziz University, College of Applied Medical Sciences, Department of Nursing, Alkharj, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mariam Awad Mazyad', 'Initials': 'MAM', 'LastName': 'Almutairi', 'Affiliation': 'Prince Sattam Bin Abdulaziz University, College of Applied Medical Sciences, Department of Nursing, Alkharj, Riyadh, Saudi Arabia.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.1.211']
515,31980932,Tolvaptan can limit postoperative paroxysmal atrial fibrillation occurrence after open-heart surgery.,"PURPOSE


Tolvaptan administration in the early postoperative period after cardiac surgery rapidly treats fluid retention without affecting the renal function. Tolvaptan also has the benefit of not stimulating the renin-angiotensin and sympathetic nervous systems, which are risk factors for postoperative paroxysmal atrial fibrillation. In this study, we examined the hypothesis that tolvaptan administration reduces postoperative paroxysmal atrial fibrillation and worsening of the renal function incidence in patients who have undergone open-heart surgery.
METHODS


From our previous randomized study, we selected 166 open-heart surgery patients, divided them into 2 groups [tolvaptan group, 83 patients; control (non-tolvaptan) group, 83 patients], and compared the incidence of postoperative paroxysmal atrial fibrillation and worsening of the renal function in the postoperative period between the groups.
RESULTS


The incidence of worsening of the renal function was significantly lower in the tolvaptan group than in the control group (4.8% vs. 15.7%; P = 0.04). The incidence of postoperative paroxysmal atrial fibrillation within 14 days was also significantly lower in the tolvaptan group than in the control group (26.5% vs. 42.2%; P = 0.011).
CONCLUSION


Tolvaptan administration in the early postoperative period after open-heart surgery may reduce the incidence of postoperative paroxysmal atrial fibrillation and worsening of the renal function.",2020,The incidence of worsening of the renal function was significantly lower in the tolvaptan group than in the control group (4.8% vs. 15.7%; P = 0.04).,"['166 open-heart surgery patients, divided them into 2 groups [tolvaptan group, 83 patients', 'patients who have undergone open-heart surgery']","['control (non-tolvaptan', 'Tolvaptan', 'tolvaptan']","['postoperative paroxysmal atrial fibrillation and worsening of the renal function', 'incidence of postoperative paroxysmal atrial fibrillation', 'incidence of postoperative paroxysmal atrial fibrillation and worsening of the renal function', 'incidence of worsening of the renal function', 'postoperative paroxysmal atrial fibrillation and worsening of the renal function incidence']","[{'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",,0.0198718,The incidence of worsening of the renal function was significantly lower in the tolvaptan group than in the control group (4.8% vs. 15.7%; P = 0.04).,"[{'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiovascular Surgery, Tottori University Faculty of Medicine, Tottori University Hospital, 36-1 Nishi-cho, Yonago, 683-8504, Japan. ynobu@xf7.so-net.ne.jp.'}, {'ForeName': 'Yuichirou', 'Initials': 'Y', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Cardiovascular Surgery, Tottori University Faculty of Medicine, Tottori University Hospital, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Harada', 'Affiliation': 'Department of Cardiovascular Surgery, Tottori University Faculty of Medicine, Tottori University Hospital, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Onohara', 'Affiliation': 'Department of Cardiovascular Surgery, Tottori University Faculty of Medicine, Tottori University Hospital, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Otsuki', 'Affiliation': 'Department of Cardiovascular Surgery, Tottori University Faculty of Medicine, Tottori University Hospital, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Hiromu', 'Initials': 'H', 'LastName': 'Horie', 'Affiliation': 'Department of Cardiovascular Surgery, Tottori University Faculty of Medicine, Tottori University Hospital, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}, {'ForeName': 'Motonobu', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'Department of Cardiovascular Surgery, Tottori University Faculty of Medicine, Tottori University Hospital, 36-1 Nishi-cho, Yonago, 683-8504, Japan.'}]",Surgery today,['10.1007/s00595-020-01962-3']
516,32406655,Three-Dimensional Volumetric Changes After Socket Augmentation with Deproteinized Bovine Bone and Collagen Matrix.,"PURPOSE


Socket augmentation decreases the magnitude of alveolar ridge resorption, but the literature is limited in respect to quantifying soft tissue remodeling. The aim of this study was to determine the volumetric and linear dimensional changes at the buccal surface for both hard and soft tissues after socket augmentation treated with a xenogeneic collagen matrix in combination with bone grafting.
MATERIALS AND METHODS


Twenty-four individuals indicated for tooth extraction were enrolled in this investigation. Each participant was randomly assigned to one of two groups: (1) deproteinized bovine bone + collagen plug, or (2) deproteinized bovine bone + xenogeneic collagen matrix. A cone beam computed tomography scan was taken prior to extraction and at 6 months postextraction. Intraoral scanning images were taken at baseline, 3 months, and 6 months postextraction. Hard and soft tissue analyses were performed to compare linear ridge remodeling and volumetric changes by noncontact reverse-engineering software.
RESULTS


Both groups showed bone and soft tissue remodeling. For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups. For soft tissue remodeling, the collagen matrix group showed a reduced soft tissue loss compared with the collagen plug group. The volumetric analysis demonstrated that the mean buccal soft tissue volume loss for the collagen matrix group was 68.6 mm 3  compared with 87.6 mm 3  found in the collagen plug group (P = .009) over a 6-month period.
CONCLUSION


This clinical investigation provides early evidence of using the total tissue volume to compare soft and hard tissue remodeling after socket augmentation. The results of this study demonstrated that the use of a xenogeneic collagen matrix reduced the buccal soft tissue loss after tooth extraction, but additional studies are necessary to evaluate the clinical significance of soft tissue augmentation after tooth extraction.",2020,"For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups.",['Twenty-four individuals indicated for tooth extraction were enrolled in this investigation'],"['Deproteinized Bovine Bone and Collagen Matrix', 'xenogeneic collagen matrix', 'deproteinized bovine bone + collagen plug, or (2) deproteinized bovine bone + xenogeneic collagen matrix']","['mean buccal soft tissue volume loss', 'alveolar ridge resorption', 'soft tissue loss', 'bone and soft tissue remodeling', 'buccal soft tissue loss']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0182324', 'cui_str': 'Plug'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",24.0,0.0170066,"For hard tissue remodeling, there was no significant difference between the collagen plug and collagen matrix groups.","[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Morelli', 'Affiliation': ''}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Monaghan', 'Affiliation': ''}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Moss', 'Affiliation': ''}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Lopez', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Marchesan', 'Affiliation': ''}]",The International journal of oral & maxillofacial implants,['10.11607/jomi.7961']
517,31970564,Photobiomodulation as an adjunctive therapy for alveolar socket preservation: a preliminary study in humans.,"Bone remodeling results in loss of alveolar bone height and thickness. Photobiomodulation (PBM) based on photochemical stimulation by low-intensity lasers emerges as an adjunctive therapy for alveolar socket preservation. Our study aimed to evaluate the effects of PBM therapy on alveolar bone repair. Twenty healthy patients in need of bilateral extraction of lower molars were enrolled in this split-mouth randomized and blind clinical trial. The extraction sites were randomly selected to receive either the PBM therapy with a CW GaAIAs diode laser (808 nm; 0.028 mm 2 ; 0.1 W; 3.6 W/cm 2 ; 89 J/cm 2 ; 2.5 J/point) or no treatment (Control). Bone biopsies were harvested 45 days after the dental extraction and evaluated using micro-computerized tomography (μCT), morphometric, and histological analysis. Data were compared using the paired t test, and the level of significance was set at 5%. Bone surface (p = 0.029), bone surface/total volume (p = 0.028), trabecular number (p = 0.025), and connectivity density (p = 0.029) were higher at the PBM group compared with Control. The histological observations confirmed the μCT findings. PBM samples exhibited higher number of organized and connected bone trabeculae along with higher density of blood vessels than Control. Control samples displayed a dense and highly cellular connective tissue at the central area accompanied by the presence of immature bone trabeculae at the periphery. Our results indicated that the PBM therapy improved the newly bone trabeculae formation and their connectivity which increased bone surface, indicating the positive effect of the laser on alveolar human socket repair.",2020,Control samples displayed a dense and highly cellular connective tissue at the central area accompanied by the presence of immature bone trabeculae at the periphery.,"['Twenty healthy patients in need of bilateral extraction of lower molars', 'humans']","['PBM therapy', 'PBM therapy with a CW GaAIAs diode laser', 'Photobiomodulation', 'Photobiomodulation (PBM']","['connectivity density', 'Bone surface', 'alveolar bone height and thickness', 'alveolar bone repair', 'trabecular number', 'bone surface/total volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",20.0,0.0400744,Control samples displayed a dense and highly cellular connective tissue at the central area accompanied by the presence of immature bone trabeculae at the periphery.,"[{'ForeName': 'Kleber Arturo Vallejo', 'Initials': 'KAV', 'LastName': 'Rosero', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rui Manuel Freire', 'Initials': 'RMF', 'LastName': 'Sampaio', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Cristina Zindel', 'Initials': 'MCZ', 'LastName': 'Deboni', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Corrêa', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Márcia Martins', 'Initials': 'MM', 'LastName': 'Marques', 'Affiliation': 'School of Dentistry, Ibirapuera University, São Paulo, Brazil.'}, {'ForeName': 'Emanuela Prado', 'Initials': 'EP', 'LastName': 'Ferraz', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil. emanuelaferraz@usp.br.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'da Graça Naclério-Homem', 'Affiliation': 'School of Dentistry, University of São Paulo, São Paulo, Brazil.'}]",Lasers in medical science,['10.1007/s10103-020-02962-y']
518,31960896,VYC-25L Hyaluronic Acid Injectable Gel Is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face.,"BACKGROUND


Juvéderm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume.
OBJECTIVE


The aim of this study was to evaluate the safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment.
METHODS


This prospective, single-blind, controlled study enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°). Subjects were randomized (3:1) to Volux at study onset or 3 months later (control group), and could receive a single repeat treatment during months 18 to 24. Assessments included mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates (improved/much improved), improvements in 3 subject-reported FACE-Q scales, and safety.
RESULTS


Of 132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment. Mean changes (95% confidence interval) in glabella-subnasale-pogonion angle from baseline for treatment and control groups, respectively, were: 1.15° (0.75°, 1.56°) and 1.16° (0.57°, 1.75°) at month 18, and 3.14° (2.68°, 3.61°) and 2.72° (1.78°, 3.66°) 1 month after repeat treatment. Investigators rated 52.5%/60.0% of treated/control subjects at month 18 and 96.9%/100% after retreatment as GAIS responders; subject-reported rates were 62.0%/64.0% and 93.8%/100%. Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-Being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment. The safety profile was as expected.
CONCLUSIONS


Volux injectable gel is a safe, effective, and durable alternative to surgical treatments for increasing chin projection and jaw volume, and results in high patient satisfaction.
LEVEL OF EVIDENCE: 2


",2020,"Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment.","['132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment', 'enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°']",['VYC-25L Hyaluronic Acid Injectable Gel'],"['FACE-Q scales, and safety', 'Mean changes', 'Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-being', 'mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates']","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0222694', 'cui_str': 'Structure of glabella'}, {'cui': 'C2334731', 'cui_str': 'Cephalometric pogonion point'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}]",132.0,0.0218295,"Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ogilvie', 'Affiliation': ''}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Benouaiche', 'Affiliation': ''}, {'ForeName': 'Wolfgang G', 'Initials': 'WG', 'LastName': 'Philipp-Dormston', 'Affiliation': ''}, {'ForeName': 'Lakhdar', 'Initials': 'L', 'LastName': 'Belhaouari', 'Affiliation': ''}, {'ForeName': 'Frodo', 'Initials': 'F', 'LastName': 'Gaymans', 'Affiliation': ''}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Sattler', 'Affiliation': ''}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schumacher', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjaa013']
519,31950977,Effect of Stress Ulcer Prophylaxis With Proton Pump Inhibitors vs Histamine-2 Receptor Blockers on In-Hospital Mortality Among ICU Patients Receiving Invasive Mechanical Ventilation: The PEPTIC Randomized Clinical Trial.,"Importance


Proton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs) are often prescribed for patients as stress ulcer prophylaxis drugs in the intensive care unit (ICU). The comparative effect of these drugs on mortality is unknown.
Objective


To compare in-hospital mortality rates using PPIs vs H2RBs for stress ulcer prophylaxis.
Design, Setting, and Participants


Cluster crossover randomized clinical trial conducted at 50 ICUs in 5 countries between August 2016 and January 2019. Patients requiring invasive mechanical ventilation within 24 hours of ICU admission were followed up for 90 days at the hospital.
Interventions


Two stress ulcer prophylaxis strategies were compared (preferential use with PPIs vs preferential use with H2RBs). Each ICU used each strategy sequentially for 6 months in random order; 25 ICUs were randomized to the sequence with use of PPIs and then use of H2RBs and 25 ICUs were randomized to the sequence with use of H2RBs and then use of PPIs (13 436 patients randomized by site to PPIs and 13 392 randomized by site to H2RBs).
Main Outcomes and Measures


The primary outcome was all-cause mortality within 90 days during index hospitalization. Secondary outcomes were clinically important upper gastrointestinal bleeding, Clostridioides difficile infection, and ICU and hospital lengths of stay.
Results


Among 26 982 patients who were randomized, 154 opted out, and 26 828 were analyzed (mean [SD] age, 58 [17.0] years; 9691 [36.1%] were women). There were 26 771 patients (99.2%) included in the mortality analysis; 2459 of 13 415 patients (18.3%) in the PPI group died at the hospital by day 90 and 2333 of 13 356 patients (17.5%) in the H2RB group died at the hospital by day 90 (risk ratio, 1.05 [95% CI, 1.00 to 1.10]; absolute risk difference, 0.93 percentage points [95% CI, -0.01 to 1.88] percentage points; P = .054). An estimated 4.1% of patients randomized by ICU site to PPIs actually received H2RBs and an estimated 20.1% of patients randomized by ICU site to H2RBs actually received PPIs. Clinically important upper gastrointestinal bleeding occurred in 1.3% of the PPI group and 1.8% of the H2RB group (risk ratio, 0.73 [95% CI, 0.57 to 0.92]; absolute risk difference, -0.51 percentage points [95% CI, -0.90 to -0.12 percentage points]; P = .009). Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group. One adverse event (an allergic reaction) was reported in 1 patient in the PPI group.
Conclusions and Relevance


Among ICU patients requiring mechanical ventilation, a strategy of stress ulcer prophylaxis with use of proton pump inhibitors vs histamine-2 receptor blockers resulted in hospital mortality rates of 18.3% vs 17.5%, respectively, a difference that did not reach the significance threshold. However, study interpretation may be limited by crossover in the use of the assigned medication.
Trial Registration


anzctr.org.au Identifier: ACTRN12616000481471.",2020,Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group.,"['50 ICUs in 5 countries between August 2016 and January 2019', 'ICU patients requiring mechanical ventilation', 'Patients Receiving Invasive Mechanical Ventilation', 'Patients requiring invasive mechanical ventilation within 24 hours of ICU admission', 'patients as stress ulcer prophylaxis drugs in the intensive care unit (ICU', '17.0] years; 9691 [36.1%] were women', '26\u202f982 patients who were randomized, 154 opted out, and 26\u202f828 were analyzed (mean [SD] age, 58']","['ICU', 'Proton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs', 'PPIs vs H2RBs', 'Proton Pump Inhibitors vs Histamine-2 Receptor Blockers', 'anzctr.org.au Identifier']","['hospital mortality rates', 'cause mortality', 'Hospital Mortality', 'Clinically important upper gastrointestinal bleeding', 'clinically important upper gastrointestinal bleeding, Clostridioides difficile infection, and ICU and hospital lengths of stay', 'Rates of Clostridioides difficile infection and ICU and hospital lengths of stay']","[{'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C2741638', 'cui_str': 'Stress ulcer (disorder)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]","[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal hemorrhage (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.126156,Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': 'Department of Critical Care Medicine, University of Alberta Hospital, Edmonton, Canada.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Forbes', 'Affiliation': 'Biostatistics Unit, Monash University, Melbourne, Australia.'}, {'ForeName': 'Alistair D', 'Initials': 'AD', 'LastName': 'Nichol', 'Affiliation': 'Intensive Care Unit, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Wright', 'Affiliation': 'Intensive Care Unit, Freeman Hospital, Newcastle upon Tyne, England.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Brickell', 'Affiliation': ""University College Dublin-Clinical Research Centre, St Vincent's Hospital, Dublin, Ireland.""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gattas', 'Affiliation': 'Intensive Care Unit, Royal Prince Alfred Hospital, Camperdown, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Haren', 'Affiliation': 'Intensive Care Unit, Canberra Hospital, Canberra, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Leanlove', 'Initials': 'L', 'LastName': 'Navarra', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Opgenorth', 'Affiliation': 'Department of Critical Care Medicine, University of Alberta Hospital, Edmonton, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pilcher', 'Affiliation': 'Intensive Care Unit, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Saxena', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Steve A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': 'Intensive Care Unit, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}]",JAMA,['10.1001/jama.2019.22190']
520,31581295,Higher Caloric Exposure in Critically Ill Patients Transiently Accelerates Thyroid Hormone Activation.,"INTRODUCTION


The inflammatory response of critical illness is accompanied by nonthyroidal illness syndrome (NTIS). Feeding has been shown to attenuate this process, but this has not been explored prospectively over time in critically ill patients.
OBJECTIVE


To explore the impact of calorie exposure on NTIS over time in critically ill patients.
METHODS


Mechanically ventilated patients with systemic inflammatory response syndrome (SIRS) were randomized to receive either 100% or 40% of their estimated caloric needs (ECN). Thyroid hormones were measured daily for 7 days or until intensive care unit discharge or death. Mixed level regression modeling was used to explore the effect of randomization group on plasma triiodothyronine (T3), reverse triiodothyronine (rT3), thyroxine (T4), and thyroid stimulating hormone (TSH), as well as the T3/rT3 ratio.
RESULTS


Thirty-five participants (n=19 in 100% ECN; n=16 in 40% ECN) were recruited. Adjusting for group differences in baseline T3/rT3 ratio, the parameters defining the fitted curves (intercept, linear effect of study day, and quadratic effect of study day) differed by randomization group (P = 0.001, P = 0.01, and P = 0.02 respectively). Plots of the fitted curves revealed that participants in the 100% ECN group had a 54% higher T3/rT3 ratio on postintervention day 1 compared with the 40% ECN group, a difference which attenuated over time. This was driven by a 23% higher plasma T3 and 10% lower plasma rT3 levels on postintervention 1.
CONCLUSIONS


Higher caloric exposure in NTIS patients transiently attenuates the drop of the plasma T3/rT3 ratio, an effect that is minimized and finally lost over the following 3 days of continued higher caloric exposure.",2020,"This was driven by a 23% higher plasma T3 and 10% lower plasma rT3 levels on post-intervention 1.
","['critically ill patients', 'Mechanically ventilated systemic inflammatory response syndrome (SIRS) patients', 'Thirty-five participants (19 in 100% ECN, 16 in 40% ECN) were recruited']","['T3/rT3', 'calorie exposure on NTIS']","['plasma T3/rT3', 'thyroid hormone activation', 'Thyroid hormones', 'plasma rT3 levels']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0760481', 'cui_str': '(3beta,5alpha,17beta)-17-hydroxyestrane-3-carbonitrile'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C4522017', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",35.0,0.385733,"This was driven by a 23% higher plasma T3 and 10% lower plasma rT3 levels on post-intervention 1.
","[{'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'McKeever', 'Affiliation': 'University of Illinois at Chicago, Department of Kinesiology and Nutrition, Chicago, Illinois.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Peterson', 'Affiliation': 'Rush University Medical Center, Department of Clinical Nutrition, Chicago, Illinois.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Lateef', 'Affiliation': 'Rush University Medical Center, Department of Clinical Nutrition, Chicago, Illinois.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Freels', 'Affiliation': 'University of Illinois at Chicago, Department of Epidemiology and Biostatistics, Chicago, Illinois.'}, {'ForeName': 'Tatiana L', 'Initials': 'TL', 'LastName': 'Fonseca', 'Affiliation': 'University of Chicago Medical Center, Section of Adult and Pediatric Endocrinology, Diabetes and Metabolism, Chicago, Illinois.'}, {'ForeName': 'Barbara M L C', 'Initials': 'BMLC', 'LastName': 'Bocco', 'Affiliation': 'University of Chicago Medical Center, Section of Adult and Pediatric Endocrinology, Diabetes and Metabolism, Chicago, Illinois.'}, {'ForeName': 'Gustavo W', 'Initials': 'GW', 'LastName': 'Fernandes', 'Affiliation': 'University of Chicago Medical Center, Section of Adult and Pediatric Endocrinology, Diabetes and Metabolism, Chicago, Illinois.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Roehl', 'Affiliation': 'Rush University Medical Center, Department of Clinical Nutrition, Chicago, Illinois.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nowak', 'Affiliation': 'Rush University Medical Center, Department of Clinical Nutrition, Chicago, Illinois.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Mozer', 'Affiliation': 'Rush University Medical Center, Department of Clinical Nutrition, Chicago, Illinois.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Bianco', 'Affiliation': 'University of Chicago Medical Center, Section of Adult and Pediatric Endocrinology, Diabetes and Metabolism, Chicago, Illinois.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Braunschweig', 'Affiliation': 'University of Illinois at Chicago, Department of Kinesiology and Nutrition, Chicago, Illinois.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz077']
521,31931806,Associations of Perfluoroalkyl substances with blood lipids and Apolipoproteins in lipoprotein subspecies: the POUNDS-lost study.,"BACKGROUND


The associations of perfluoroalkyl substance (PFAS) exposure with blood lipids and lipoproteins are inconsistent, and existing studies did not account for metabolic heterogeneity of lipoprotein subspecies. This study aimed to examine the associations between plasma PFAS concentrations and lipoprotein and apolipoprotein subspecies.
METHODS


The study included 326 men and women from the 2-year Prevention of Obesity Using Novel Dietary Strategies (POUNDS) Lost randomized trial. Five PFASs, including perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorohexanesulfonic acid (PFHxS), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA), were measured in plasma at baseline. For lipoprotein and apolipoprotein subspecies, total plasma was fractionated first by apolipoprotein (apo) C-III content and then by density. Each subfraction was then measured for apoB, apoC-III, and apoE concentrations, as well as triglyceride and cholesterol contents, both at baseline and at 2 years.
RESULTS


For lipids and apolipoproteins in total plasma at baseline, elevated plasma PFAS concentrations were significantly associated with higher apoB and apoC-III concentrations, but not with total cholesterol or triglycerides. After multivariate adjustment of lifestyle factors, lipid-lowering medication use, and dietary intervention groups, PFAS concentrations were primarily associated with lipids or apolipoprotein concentrations in intermediate-to-low density lipoprotein (IDL + LDL) and high-density lipoprotein (HDL) that contain apoC-III. Comparing the highest and lowest tertiles of PFOA, the least-square means (SE) (mg/dl) were 4.16 (0.4) vs 3.47 (0.4) for apoB (P trend = 0.04), 2.03 (0.2) vs 1.66 (0.2) for apoC-III (P trend = 0.04), and 8.4 (0.8) vs 6.8 (0.8) for triglycerides (P trend = 0.03) in IDL + LDL fraction that contains apoC-III. For HDL that contains apoC-III, comparing the highest and lowest tertiles of PFOA, the least-square means (SE) (mg/dl) of apoC-III were 11.9 (0.7) vs 10.4 (0.7) (P trend = 0.01). In addition, elevated PFNA and PFDA concentrations were also significantly associated with higher concentrations of apoE in HDL that contains apoC-III (P trend< 0.01). Similar patterns of associations were demonstrated between baseline PFAS concentrations and lipoprotein subspecies measured at 2 years. Baseline PFAS levels were not associated with changes in lipoprotein subspecies during the intervention.
CONCLUSIONS


Our results suggest that plasma PFAS concentrations are primarily associated with blood lipids and apolipoproteins in subspecies of IDL, LDL, and HDL that contain apoC-III, which are associated with elevated cardiovascular risk in epidemiological studies. Future studies of PFAS-associated cardiovascular risk should focus on lipid subfractions.",2020,"Baseline PFAS levels were not associated with changes in lipoprotein subspecies during the intervention.
",['326 men and women from the 2-year Prevention of Obesity Using Novel Dietary Strategies (POUNDS'],['Perfluoroalkyl substances with blood lipids and Apolipoproteins'],"['lipids or apolipoprotein concentrations in intermediate-to-low density lipoprotein (IDL\u2009+\u2009LDL) and high-density lipoprotein (HDL', 'Baseline PFAS levels', 'elevated PFNA and PFDA concentrations', 'baseline PFAS concentrations and lipoprotein subspecies', 'perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorohexanesulfonic acid (PFHxS), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA', 'total cholesterol or triglycerides', 'For lipoprotein and apolipoprotein subspecies, total plasma was fractionated first by apolipoprotein (apo) C-III content', 'apoB, apoC-III, and apoE concentrations, as well as triglyceride and cholesterol contents', 'lipoprotein subspecies', 'total plasma at baseline, elevated plasma PFAS concentrations']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439219', 'cui_str': 'lb'}]","[{'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0523476', 'cui_str': 'Apolipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0172926', 'cui_str': 'perfluorooctanesulfonic acid'}, {'cui': 'C0070403', 'cui_str': 'perfluorooctanoic acid'}, {'cui': 'C1174119', 'cui_str': 'perfluorohexanesulfonic acid'}, {'cui': 'C3712911', 'cui_str': 'Nonanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluoro-'}, {'cui': 'C0070396', 'cui_str': 'perfluorodecanoic acid'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0052191', 'cui_str': 'Apolipoprotein CIII'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C4048315', 'cui_str': 'ApoC-III'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}]",326.0,0.0366429,"Baseline PFAS levels were not associated with changes in lipoprotein subspecies during the intervention.
","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, Ministry of Education Key Laboratory of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Biochemistry, Fukuoka University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 665 Huntington Ave, Boston, MA, 02115, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, LSU, Baton Rouge, LA, USA.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Epidemiology and Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, LSU, Baton Rouge, LA, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'DeJonge', 'Affiliation': 'Department of Nutrition and Food Studies, George Mason University, Fairfax, VA, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Coull', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grandjean', 'Affiliation': 'Institute of Public Health, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Furtado', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 665 Huntington Ave, Boston, MA, 02115, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, 665 Huntington Ave, Boston, MA, 02115, USA. qisun@hsph.harvard.edu.'}]",Environmental health : a global access science source,['10.1186/s12940-020-0561-8']
522,31947043,The Effects of Anti-gravity Treadmill Training on Gait Characteristics in Children with Cerebral Palsy.,"Cerebral palsy is a disorder that affects muscle tone, movement and motor skills. Most of the children with cerebral palsy (CP) are not able to walk or can walk in incorrect pattern and are dependent on assistive devices. Recently an antigravity treadmill has been found to be beneficial as a new therapeutic approach. Thus, we aimed to investigate the effects of antigravity treadmill training (AlterG) on gait characteristic in children with cerebral palsy. We provided a 45-minute training program, 3 times a week for 8 weeks for six CP children as our experimental group. Our control group was a group consisted of four CP children who took typical occupational therapy, accordingly. All subjects in both AlterG and control groups were evaluated at the gait lab before and after 8 weeks training. Gait patterns were characterized using spatiotemporal parameters and dynamic balance features. We also evaluated the popular clinical gait measures including walking speed and endurance, and mobility and balance.Our results demonstrated that spatiotemporal, dynamic balance and clinical features all improved more after 8 weeks AlterG training rather than control group ones. These findings suggest that AlterG training can be considered as an effective approach for improving walking ability and gait characteristics in children with cerebral palsy.",2019,"Our results demonstrated that spatiotemporal, dynamic balance and clinical features all improved more after 8 weeks AlterG training rather than control group ones.","['children with cerebral palsy', 'Children with Cerebral Palsy', 'children with cerebral palsy (CP']","['CP children who took typical occupational therapy', 'antigravity treadmill', 'antigravity treadmill training (AlterG', 'AlterG training', 'Anti-gravity Treadmill Training']","['walking ability and gait characteristics', 'walking speed and endurance, and mobility and balance', 'Gait Characteristics']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0126112,"Our results demonstrated that spatiotemporal, dynamic balance and clinical features all improved more after 8 weeks AlterG training rather than control group ones.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lotfian', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dadashi', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Rafieenazari', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shahroki', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rasteh', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Molavi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirbagheri', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2019.8856660']
523,31761417,Methadone versus morphine for postoperative pain in patients undergoing surgery for gynecological cancer: A randomized controlled clinical trial.,"STUDY OBJECTIVE


The aim of this study was to compare methadone and morphine for the management of postoperative.
DESIGN


Open, controlled study.
SETTING


Postoperative recovering area, ward.
PATIENTS


Sixty-four patients, ASA I-III, undergoing gynecological surgery for cancer.
INTERVENTIONS


Morphine or methadone 0.15 mg/kg given preoperatively. After operation an intravenous morphine or intravenous methadone infusion at doses of 12 mg/day was started.
MEASUREMENTS


Pain intensity and opioid consumption.
MAIN RESULTS


Methadone infusion provided a better analgesia in comparison with morphine infusion on the second day. Opioid consumption was significantly lower in the methadone group. No episodes of relevant desaturation or signs of respiratory depression were recorded.
CONCLUSION


A preoperative bolus of methadone, followed by a continuous infusion of low doses post-operatively, provided a better analgesia, without adding risk of adverse effects, in comparison with morphine.",2020,Opioid consumption was significantly lower in the methadone group.,"['Sixty-four patients, ASA I-III, undergoing gynecological surgery for cancer', 'Postoperative recovering area, ward', 'patients undergoing surgery for gynecological cancer']","['methadone', 'morphine', 'Methadone', 'Morphine or methadone 0.15', 'methadone and morphine']","['episodes of relevant desaturation or signs of respiratory depression', 'Pain intensity and opioid consumption', 'Opioid consumption']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}]","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0235063', 'cui_str': 'Respiratory Depression'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",64.0,0.210492,Opioid consumption was significantly lower in the methadone group.,"[{'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Mercadante', 'Affiliation': 'Anesthesia and Intensive Care Unit, Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy. Electronic address: terapiadeldolore@lamaddalenanet.it.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'David', 'Affiliation': 'Anesthesia and Intensive Care Unit, Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Villari', 'Affiliation': 'Anesthesia and Intensive Care Unit, Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy.'}, {'ForeName': 'Vincenza Manuela', 'Initials': 'VM', 'LastName': 'Spedale', 'Affiliation': 'Anesthesia and Intensive Care Unit, Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Casuccio', 'Affiliation': 'Department of Sciences for Health Promotion and Mother Child Care, University of Palermo, Italy.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.109627']
524,31668468,A randomized control trial comparing prophylactic dexmedetomidine versus clonidine on rates and duration of delirium in older adult patients undergoing coronary artery bypass grafting.,"STUDY OBJECTIVE


Postoperative delirium occurs in 20-50% of elderly patients undergoing cardiac surgery and increases morbidity and mortality. We investigated whether prophylactic dexmedetomidine could reduce delirium incidence in elderly patients after coronary artery bypass grafting (CABG), compared with clonidine.
DESIGN


Prospective observational trial.
SETTING


Academic university hospital.
PARTICIPANTS


Patients (60-70 years old) who underwent CABG and received either dexmedetomidine or clonidine infusion postoperatively.
INTERVENTIONS


Patients were randomly allocated to dexmedetomidine or clonidine groups. In the dexmedetomidine group, patients received an initial infusion of 0.7-1.2 μg/kg/h; sedation and analgesia were evaluated after 45-60 min. If the Richmond assessment sedation score (RASS) increased from +1 to +4, the infusion rate was increased by 0.1-0.2 μg/kg/h every 30 min, up to 1-1.4 μg/kg body-weight/h. Dexmedetomidine infusion was not discontinued pre-extubation; thereafter, infusion was reduced by 0.1 μg/kg/h until 0.2 μg/kg/h. The maximum infusion duration was 72 h. In the clonidine group, patients received an initial infusion of 0.5 μg/kg, followed by 1-2 μg/kg/h, if the RASS changed from +1 to +4. This was continued throughout mechanical ventilation.
MEASUREMENTS


Patients were followed up to 5 days post-surgery. Delirium incidence, extubation time, lengths of intensive care unit (ICU) and hospital stay, need for inotropic support or vasopressors, mean arterial blood pressure and heart rate, hospital mortality rate, total postoperative morphine dose, number of patients receiving haloperidol, and adverse events were recorded.
MAIN RESULTS


Two-hundred-and-eighty-six patients (dexmedetomidine, 144; clonidine, 142) were studied. Dexmedetomidine was associated with lower risk and duration of delirium, shorter mechanical ventilation duration and ICU stay, lower mortality rate, and lower morphine consumption than the clonidine group. Dexmedetomidine significantly decreased heart rates after ICU admission.
CONCLUSIONS


Postoperative infusion of dexmedetomidine provides a feasible option for postoperative control of delirium after CABG in adult patients.",2020,"Dexmedetomidine was associated with lower risk and duration of delirium, shorter mechanical ventilation duration and ICU stay, lower mortality rate, and lower morphine consumption than the clonidine group.","['Academic university hospital', 'Patients (60-70\u202fyears old) who underwent', 'older adult patients undergoing coronary artery bypass grafting', 'adult patients', 'Two-hundred-and-eighty-six patients (dexmedetomidine, 144', 'elderly patients after coronary artery bypass grafting (CABG', '20-50% of elderly patients undergoing']","['dexmedetomidine or clonidine infusion postoperatively', 'prophylactic dexmedetomidine', 'dexmedetomidine', 'Dexmedetomidine', 'cardiac surgery', 'CABG', 'dexmedetomidine or clonidine', 'clonidine']","['maximum infusion duration', 'rates and duration of delirium', 'lower risk and duration of delirium, shorter mechanical ventilation duration and ICU stay, lower mortality rate, and lower morphine consumption', 'delirium incidence', 'infusion rate', 'Delirium incidence, extubation time, lengths of intensive care unit (ICU) and hospital stay, need for inotropic support or vasopressors, mean arterial blood pressure and heart rate, hospital mortality rate, total postoperative morphine dose, number of patients receiving haloperidol, and adverse events', 'morbidity and mortality', 'sedation score (RASS', 'heart rates']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",286.0,0.285706,"Dexmedetomidine was associated with lower risk and duration of delirium, shorter mechanical ventilation duration and ICU stay, lower mortality rate, and lower morphine consumption than the clonidine group.","[{'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Shokri', 'Affiliation': 'Ain Shams University, Cairo, Egypt. Electronic address: Drhoda10@yahoo.com.'}, {'ForeName': 'Ihab', 'Initials': 'I', 'LastName': 'Ali', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.09.016']
525,31918685,"Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration - results from the randomized, phase IIIb OCTAVE study.","BACKGROUND


To evaluate the efficacy and safety of two individualized ranibizumab retreatment schemes in neovascular age-related macular degeneration.
METHODS


Patients (N = 671) were randomized (1:1) to receive three initial monthly ranibizumab 0.5 mg injections, then retreatment guided by either best-corrected visual acuity (BCVA) loss (Group I) or BCVA loss and/or signs of disease activity on optical coherence tomography (OCT; Group II). The study was terminated prematurely and the decision to discontinue the study was made by the sponsor. Efficacy analyses were performed on patients who completed 12 months of the originally planned 24-month study. Safety analyses are presented for all safety analyzable patients.
RESULTS


Of 671 randomized patients, 305 completed 12 months of the study. For the 12-month completers, baseline mean (standard deviation) BCVA and reading-center evaluated central subfield thickness (CSFT) were comparable [Group I: 60.9 (13.10) letters and 517.7(201.79) μm; Group II: 60.2 (12.21) letters and 515.3 (198.37) μm]. The change from baseline at Month 12 in BCVA was 6.7 (13.48) letters in Group I and 8.3 (13.53) letters in Group II and the change in CSFT was - 161.3 (163.48) μm and - 175.3 (170.45) μm, respectively. The mean number of ranibizumab injections was 8.2 in Group I and 8.4 in Group II.
CONCLUSION


Ranibizumab treatment resulted in visual and anatomic gains at 12 months for both retreatment strategies, with a trend in favor of OCT-guided vs BCVA loss guided retreatment. No new safety signals were seen.
TRIAL REGISTRATION


www.ClinicalTrials.gov (NCT01780935). Registered 31 January 2013.",2020,"CONCLUSION


Ranibizumab treatment resulted in visual and anatomic gains at 12 months for both retreatment strategies, with a trend in favor of OCT-guided vs BCVA loss guided retreatment.","['patients who completed 12\u2009months of the originally planned 24-month study', 'Patients (N\u2009=\u2009671', '671 randomized patients', 'neovascular age-related macular degeneration', 'patients with neovascular age-related macular degeneration ']","['Ranibizumab', 'Functional versus functional and anatomical criteria-guided ranibizumab treatment', 'ranibizumab 0.5\u2009mg injections, then retreatment guided by either best-corrected visual acuity (BCVA) loss (Group I) or BCVA loss and/or signs of disease activity on optical coherence tomography (OCT']","['baseline mean (standard deviation) BCVA and reading-center evaluated central subfield thickness (CSFT', 'mean number of ranibizumab injections', 'efficacy and safety', 'visual and anatomic gains']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4060225', 'cui_str': 'ranibizumab Injection [Lucentis]'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}]",671.0,0.0919142,"CONCLUSION


Ranibizumab treatment resulted in visual and anatomic gains at 12 months for both retreatment strategies, with a trend in favor of OCT-guided vs BCVA loss guided retreatment.","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Staurenghi', 'Affiliation': 'Department of Biomedical and Clinical Sciences ""Luigi Sacco"", Sacco Hospital, University of Milan, G. B. Grassi, 74, 20157, Milan, Italy. giovanni.staurenghi@unimi.it.'}, {'ForeName': 'Justus G', 'Initials': 'JG', 'LastName': 'Garweg', 'Affiliation': 'Berner Augenklinik am Lindenhofspital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bianca S', 'Initials': 'BS', 'LastName': 'Gerendas', 'Affiliation': 'Vienna Reading Center, Department of Ophthalmology and Optometry, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Macfadden', 'Affiliation': 'International Psychiatric Services, 1900 JFK Boulevard, #621, Philadelphia, PA, 19103, USA.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Gekkiev', 'Affiliation': 'Novartis Pharma AG, Postfach, 4002, Basel, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Margaron', 'Affiliation': 'Novartis Pharma AG, Postfach, 4002, Basel, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Dunger-Baldauf', 'Affiliation': 'Novartis Pharma AG, Postfach, 4002, Basel, Switzerland.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kolar', 'Affiliation': 'Slowak Medical University and University Hospital Bratislava, Antolska 11, 85107, Bratislava, Slovakia.'}]",BMC ophthalmology,['10.1186/s12886-019-1251-6']
526,31669049,"Comparison of clinical outcomes of acetaminophen IV vs PO in the peri-operative setting for laparoscopic inguinal hernia repair surgeries: A triple-blinded, randomized controlled trial.","BACKGROUND


Acetaminophen is available in a variety of modalities but there is conflicting evidence as to whether intravenous provides superior analgesia than oral formulations METHODS: A prospective, randomized, triple-blinded clinical trial was conducted in which 100 participants, scheduled for any laparoscopic unilateral hernia repair surgery in the ambulatory setting, were computer randomized to receive either 975 mg oral acetaminophen or 1000 mg of intravenous acetaminophen. The primary outcomes evaluated were post-anesthesia care unit (PACU) pain scores at arrival, 1 hour discharge, 6 hour post-op as well as total opioid use intraoperatively and in PACU. Secondary outcomes were PACU length of stay, patient reported total opioid use in the first 24 h, pain scores 24 hour post-op and patient satisfaction.
RESULTS


We found that no significant difference was appreciated between the oral and intravenous acetaminophen groups in any of the primary or secondary outcomes with the p-value of the pain score on arrival of 0.173, pain score at 1 h 0.544, pain score on discharge from PACU 0.586, pain score at 6 h 0.234, pain score at 24 h 0.133, total morphine milligram equivalents (MME) intraoperatively 0.096, total MME in PACU 0.960, time in PACU 0.15, home opioid MME 0.336, and overall patient satisfaction 0.067.
CONCLUSIONS


We concluded that in the ambulatory surgery population the efficacy of oral and intravenous acetaminophen is equivalent.",2020,"We found that no significant difference was appreciated between the oral and intravenous acetaminophen groups in any of the primary or secondary outcomes with the p-value of the pain score on arrival of 0.173, pain score at 1 h 0.544, pain score on discharge from PACU 0.586, pain score at 6 h 0.234, pain score at 24 h 0.133, total morphine milligram equivalents (MME) intraoperatively 0.096, total MME in PACU 0.960, time in PACU 0.15, home opioid MME 0.336, and overall patient satisfaction 0.067.
","['100 participants, scheduled for any laparoscopic unilateral hernia repair surgery in the ambulatory setting', 'laparoscopic inguinal hernia repair surgeries']","['975\u202fmg oral acetaminophen or 1000\u202fmg of intravenous acetaminophen', 'acetaminophen', 'Acetaminophen', 'acetaminophen IV vs PO']","['pain score on discharge from PACU 0.586, pain score', 'pain score', 'post-anesthesia care unit (PACU) pain scores at arrival, 1\u202fhour discharge, 6\u202fhour post-op as well as total opioid use intraoperatively and in PACU', 'PACU length of stay, patient reported total opioid use in the first 24\u202fh, pain scores 24\u202fhour post-op and patient satisfaction', 'pain score on arrival of 0.173, pain score']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0019328', 'cui_str': 'Hernia Repair'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}]","[{'cui': 'C4517911', 'cui_str': '975 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",100.0,0.36252,"We found that no significant difference was appreciated between the oral and intravenous acetaminophen groups in any of the primary or secondary outcomes with the p-value of the pain score on arrival of 0.173, pain score at 1 h 0.544, pain score on discharge from PACU 0.586, pain score at 6 h 0.234, pain score at 24 h 0.133, total morphine milligram equivalents (MME) intraoperatively 0.096, total MME in PACU 0.960, time in PACU 0.15, home opioid MME 0.336, and overall patient satisfaction 0.067.
","[{'ForeName': 'Alopi', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': ""Mount Sinai West and St. Luke's, Department of Anesthesiology, Perioperative and Pain Medicine, New York, NY, USA. Electronic address: Alopi.patel@mountsinai.org.""}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Pai B H', 'Affiliation': ""Mount Sinai West and St. Luke's, Department of Anesthesiology, Perioperative and Pain Medicine, New York, NY, USA.""}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Diskina', 'Affiliation': 'NYU Langone Hospital, Department of Anesthesiology, New York, NY, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Reardon', 'Affiliation': ""Mount Sinai West and St. Luke's, Department of Anesthesiology, Perioperative and Pain Medicine, New York, NY, USA. Electronic address: Brittany.reardon@mountsinai.org.""}, {'ForeName': 'Yan H', 'Initials': 'YH', 'LastName': 'Lai', 'Affiliation': ""Mount Sinai West and St. Luke's, Department of Anesthesiology, Perioperative and Pain Medicine, New York, NY, USA. Electronic address: Yan.lai@mountsinai.org.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.109628']
527,31669050,"Dexmedetomidine exerts a protective effect on ischemia-reperfusion injury after hepatectomy: A prospective, randomized, controlled study.","STUDY OBJECTIVE


Dexmedetomidine, a highly selective α 2 -receptor agonist, has been widely used for protection against ischemia-reperfusion (IR) injury. We hypothesized that dexmedetomidine might exert a protective effect on IR injury after hepatectomy.
DESIGN


A prospective, randomized, single-blind study was conducted in 58 patients undergoing hepatectomy who were randomly assigned to two study groups. The dexmedetomidine group (D group) received a loading dose of 0.5 μg/kg for 10 min, and maintained it with 0.5 μg/kg/h until resection of the liver lobes. The control group (C group), received 0.9% sodium chloride administered in the same volume and infusion rate as D group. Eleven patients had hepatic inflow occlusion in D group as did 14 patients in C group.
MEASUREMENTS


The primary outcome was the serum concentration of α-glutathione S-transferase (α-GST), which reflects hepatic ischemic injury. Secondary outcomes included laboratory variables reflecting inflammatory responses, liver and kidney function, and blood coagulation, as well as hemodynamic changes, recovery variables, and complications related to anesthesia and surgery.
RESULTS


The concentration of α-GST at 0.5 h after resection was significantly lower in the dexmedetomidine group than the control group (9.1 ± 3.4 ng/mL vs 15.8 ± 6.5 ng/mL; p < .01), and was also significantly lower in the dexmedetomidine group in subgroup analyses of patients with and without hepatic inflow occlusion. While the concentrations of α-GST at 0.5 h after resection in patients with or without occlusion in D group were comparable, in C group the α-GST concentration without occlusion was significantly higher than that with occlusion. There was an interaction between dexmedetomidine and no occlusion (p < .01), and its concentration in D group without occlusion was the lowest of all subgroups. In addition, there were significant differences in interleukin (IL)-6 and tumor necrosis (TNF)-α concentrations at 24 h after hepatectomy between the two groups, and mean arterial pressure, heart rate, and the bispectral index were also significantly lower in D group than in C group (p < .05). There were significant differences between the two groups in ALT and AST at 2 h and 24 h after the resection of the liver lobe. However, there were no significant differences in renal function, recovery variables, blood coagulation. No severe complications related surgeries and anesthesia were found in both groups.
CONCLUSION


Dexmedetomidine exerts a protective effect on ischemia-reperfusion injury after hepatectomy.",2020,"In addition, there were significant differences in interleukin (IL)-6 and tumor necrosis (TNF)-α concentrations at 24 h after hepatectomy between the two groups, and mean arterial pressure, heart rate, and the bispectral index were also significantly lower in D group than in C group (p < .05).","['ischemia-reperfusion injury after hepatectomy', '58 patients undergoing hepatectomy']","['dexmedetomidine', '0.9% sodium chloride', 'loading dose of 0.5\u202fμg/kg for 10\u202fmin, and maintained it with 0.5\u202fμg/kg/h until resection of the liver lobes', 'Dexmedetomidine']","['hepatic inflow occlusion', 'renal function, recovery variables, blood coagulation', 'mean arterial pressure, heart rate, and the bispectral index', 'laboratory variables reflecting inflammatory responses, liver and kidney function, and blood coagulation, as well as hemodynamic changes, recovery variables, and complications related to anesthesia and surgery', 'serum concentration of α-glutathione S-transferase (α-GST), which reflects hepatic ischemic injury', 'concentrations of α-GST', 'concentration of α-GST', 'interleukin (IL)-6 and tumor necrosis (TNF)-α concentrations', 'α-GST concentration without occlusion']","[{'cui': 'C0035126', 'cui_str': 'Ischemia-Reperfusion Injury'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1720302', 'cui_str': 'Until'}]","[{'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0005778', 'cui_str': 'Blood Clotting'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0017837', 'cui_str': 'Glutathione Organic Nitrate Ester Reductase'}, {'cui': 'C0069227', 'cui_str': 'O-(glucuronic acid 2-sulfate)-(1--3)-O-(2,5)-andydrotalitol 6-sulfate'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0333516', 'cui_str': 'Tumor necrosis (morphologic abnormality)'}]",58.0,0.0877935,"In addition, there were significant differences in interleukin (IL)-6 and tumor necrosis (TNF)-α concentrations at 24 h after hepatectomy between the two groups, and mean arterial pressure, heart rate, and the bispectral index were also significantly lower in D group than in C group (p < .05).","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China; Anesthesia and Operation Center, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Institute of Geriatrics, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Anesthesia and Operation Center, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jiangbei', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Anesthesia and Operation Center, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Mi', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China; Anesthesia and Operation Center, The First Medical Center, Chinese PLA General Hospital, Beijing, China. Electronic address: wwdd1962@aliyun.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.109631']
528,31928523,Hypnosis in Women with Breast Cancer: Its Effects on Cytokines.,"The aim of the present study was to evaluate the effects of hypnosis on the cytokine levels of women with breast cancer during chemotherapy. Patients with a recent breast cancer diagnosis were assigned to either a control group (n = 20) or to a hypnosis group (n = 20). The control group received standard medical care, while the hypnosis group received 24 sessions of hypnosis over 6 months as an adjuvant therapy to standard medical care. Three blood samples were obtained, one before the initiation of chemotherapy, the second a month after beginning treatment, and the third at the end of treatment. At the end of chemotherapy treatment, the control group showed significantly higher levels of tumor necrosis factor alpha (TNF-α) and granulocyte colony stimulation factor (G-CSF) compared to the hypnosis group. Stabilized G-CSF and TNF-α levels during chemotherapy in the hypnosis group could be considered as beneficial because high levels of these cytokines have been associated with increased levels of tumor growth and metastasis in cancer patients.",2020,"At the end of chemotherapy treatment, the control group showed significantly higher levels of tumor necrosis factor alpha (TNF-α) and granulocyte colony stimulation factor (G-CSF) compared to the hypnosis group.","['women with breast cancer during chemotherapy', 'cancer patients', 'Patients with a recent breast cancer diagnosis', 'Women with Breast Cancer']","['standard medical care, while the hypnosis group received 24 sessions of hypnosis over 6 months as an adjuvant therapy to standard medical care', 'hypnosis group', 'Hypnosis', 'hypnosis']","['levels of tumor necrosis factor alpha (TNF-α) and granulocyte colony stimulation factor (G-CSF', 'cytokine levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C3888013', 'cui_str': 'Hypnotism'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",,0.0191702,"At the end of chemotherapy treatment, the control group showed significantly higher levels of tumor necrosis factor alpha (TNF-α) and granulocyte colony stimulation factor (G-CSF) compared to the hypnosis group.","[{'ForeName': 'Arnoldo', 'Initials': 'A', 'LastName': 'Téllez', 'Affiliation': 'Center of Research and Development on Health Sciences, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mêxico.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rodríguez-Padilla', 'Affiliation': 'Universidad Autónoma de Nuevo León Facultad de Ciencias Biológicas, San Nicolas de los Garza, Mêxico.'}, {'ForeName': 'Dehisy Marisol', 'Initials': 'DM', 'LastName': 'Juárez-García', 'Affiliation': 'Universidad Autonoma de Nuevo Leon, Centro de Investigación y Desarrollo en Ciencias de la Salud, San Nicolas de los Garza, Mêxico.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Jaime-Bernal', 'Affiliation': 'Universidad Autonoma de Nuevo Leon, San Nicolas de los Garza, Mêxico.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sanchez-Jáuregui', 'Affiliation': 'Universidad Autonoma de Nuevo Leon, San Nicolas de los Garza, Mêxico.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Almaraz-Castruita', 'Affiliation': 'Universidad Autonoma de Nuevo Leon Centro de Investigacion y Desarrollo en Ciencias de la Salud, Monterrey, Mêxico.'}, {'ForeName': 'Herlinda', 'Initials': 'H', 'LastName': 'Vielma-Ramírez', 'Affiliation': 'Universidad Autonoma de Nuevo Leon Facultad de Ciencias Biologicas, San Nicolas de los Garza, Mêxico.'}]",The American journal of clinical hypnosis,['10.1080/00029157.2019.1611536']
529,31026738,Consumption of Brazil nuts with high selenium levels increased inflammation biomarkers in obese women: A randomized controlled trial.,"OBJECTIVE


Increased inflammatory response is an important factor in the pathophysiology of obesity. The mineral selenium (Se), of which one of the main food sources is the Brazil nut, has important antioxidant and anti-inflammatory functions through the action of selenoproteins. Thus, the evaluation of the influence of this micronutrient in this context is of great relevance. The aim of this study was to evaluate the effects of Brazil nut intake with high Se concentrations on inflammatory biomarkers and its relation to Se status in obese women.
METHODS


A randomized controlled clinical trial was carried out with 55 women recruited at Clinical Hospital in São Paulo, Brazil. Patients were randomly assigned to either the Brazil nut group (BN) or the control group (CO) and followed up for 2 mo. The BN group consumed 1 unit/d of Brazil nuts (∼ 1261 μg/Se); the CO group did not receive any intervention. At baseline and after 2 mo, analysis of biochemical parameters related to Se status, oxidative stress, and inflammatory biomarkers were performed.
RESULTS


At baseline, both groups did not present Se deficiency. In the BN group, a significant increase (P < 0.05) in all Se biomarkers and in gene expression of several proinflammatory parameters (interleukin-6, tumor necrosis factor-α, and Toll-like receptors 2 and 4) were observed after the intervention period. No changes were observed for the CO group.
CONCLUSION


Although there were no changes in plasma inflammatory biomarkers levels, a significant increase in gene expression may be an indication of a proinflammatory stimulus in obesity, induced by the consumption of Brazil nuts with high Se levels.",2019,"In the BN group, a significant increase (P < 0.05) in all Se biomarkers and in gene expression of several proinflammatory parameters (interleukin-6, tumor necrosis factor-α, and Toll-like receptors 2 and 4) were observed after the intervention period.","['55 women recruited at Clinical Hospital in São Paulo, Brazil', 'obese women']","['Brazil nut group (BN) or the control group (CO', 'Brazil nuts', 'Brazil nut intake', 'Brazil nuts with high selenium levels']","['plasma inflammatory biomarkers levels', 'Se status, oxidative stress, and inflammatory biomarkers', 'gene expression of several proinflammatory parameters (interleukin-6, tumor necrosis factor-α, and Toll-like receptors 2 and 4', 'inflammation biomarkers']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0440287', 'cui_str': 'Brazil nut (substance)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0754728', 'cui_str': 'Toll-Like Receptor 2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",55.0,0.0388039,"In the BN group, a significant increase (P < 0.05) in all Se biomarkers and in gene expression of several proinflammatory parameters (interleukin-6, tumor necrosis factor-α, and Toll-like receptors 2 and 4) were observed after the intervention period.","[{'ForeName': 'Graziela Biude Silva', 'Initials': 'GBS', 'LastName': 'Duarte', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Science, University of São Paulo, São Paulo, Brazil. Electronic address: Gbiude@usp.br.'}, {'ForeName': 'Bruna Zavarize', 'Initials': 'BZ', 'LastName': 'Reis', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Science, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Macedo', 'Initials': 'MM', 'LastName': 'Rogero', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, São Paulo, Brazil; Food Research Center (FoRC), CEPID-FAPESP, Research Innovation and Dissemination Centers São Paulo Research Foundation, São Paulo, Brazil.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Vargas-Mendez', 'Affiliation': 'Department of Biochemistry, School of Medicine, University of Costa Rica, Costa Rica.'}, {'ForeName': 'Fernando Barbosa', 'Initials': 'FB', 'LastName': 'Júnior', 'Affiliation': 'Department of Clinical, Toxicological and Bromatological Analysis, Faculty of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'Cercato', 'Affiliation': 'Division of Endocrinology and Metabolism, Clinical Hospital, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Silvia Maria Franciscato', 'Initials': 'SMF', 'LastName': 'Cozzolino', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Science, University of São Paulo, São Paulo, Brazil.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.02.009']
530,31784303,Effects of protective mechanical ventilation during general anesthesia in patients undergoing peripheral vascular surgery: A randomized controlled trial.,,2020,,['patients undergoing peripheral vascular surgery'],['protective mechanical ventilation'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C3714645', 'cui_str': 'Vascular surgery'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]",[],,0.486113,,"[{'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'Schmidt', 'Affiliation': 'Programa de Pós-graduação em Ciências Pneumológicas, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil; Serviço de Anestesia e Medicina Perioperatória e Centro de Pesquisa Experimental, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil; Departamento de Bioquímica, Instituto de Ciências Básicas da Saúde (ICBS), Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil; Serviço de Anestesia, Departamento de Cirurgia, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil; Serviço de Anestesia Cardiovascular, Hospital Nossa Senhora da Conceição, Porto Alegre, RS, Brazil. Electronic address: aschmidt@ufrgs.br.'}, {'ForeName': 'Alice J', 'Initials': 'AJ', 'LastName': 'Marques', 'Affiliation': 'Serviço de Anestesia e Medicina Perioperatória e Centro de Pesquisa Experimental, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Reinstein', 'Affiliation': 'Serviço de Anestesia e Medicina Perioperatória e Centro de Pesquisa Experimental, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Clovis T', 'Initials': 'CT', 'LastName': 'Bevilacqua Filho', 'Affiliation': 'Serviço de Anestesia e Medicina Perioperatória e Centro de Pesquisa Experimental, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Maria José C', 'Initials': 'MJC', 'LastName': 'Carmona', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'José Otávio C', 'Initials': 'JOC', 'LastName': 'Auler', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), São Paulo, SP, Brazil.'}, {'ForeName': 'Elaine A', 'Initials': 'EA', 'LastName': 'Felix', 'Affiliation': 'Serviço de Anestesia e Medicina Perioperatória e Centro de Pesquisa Experimental, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Cristiano F', 'Initials': 'CF', 'LastName': 'Andrade', 'Affiliation': 'Programa de Pós-graduação em Ciências Pneumológicas, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.109656']
531,31818636,Effects of remote ischemic preconditioning on regional cerebral oxygen saturation in patients in the beach chair position during shoulder surgery: A double-blind randomized controlled trial.,"STUDY OBJECTIVE


The beach chair position for shoulder surgery induces cerebral hypoperfusion. We evaluated the effects of remote ischemic preconditioning (RIPC) prior to surgery to ameliorate cerebral desaturation in a double-blind randomized fashion.
DESIGN


Blinded, prospective, randomized study.
SETTING


Operating room & postoperative recovery room, tertiary university hospital.
PATIENTS


Seventy patients scheduled for shoulder surgery were recruited. After excluding 7 patients according to the exclusion criteria, 63 patients were randomized into two groups (control and RIPC).
INTERVENTIONS


Remote ischemic preconditioning was applied by briefly inflating a tourniquet on the thigh three times just after inducing anesthesia in the RIPC group.
MEASUREMENTS


The changes in regional cerebral oxygen saturation, hemodynamic values, laboratory values, and serum levels of cytokines including interleukin (IL)-1β, IL-6, IL-10 and transforming growth factor-β were measured.
MAIN RESULTS


The remote ischemic preconditioning group had higher regional cerebral oxygen saturation just after establishment of the beach chair position (P = 0.002) and lower cerebral desaturation (P = 0.007) during operation than the control group. Hemodynamic and laboratory values did not differ between the groups. There were no significant intergroup differences in cytokine levels.
CONCLUSION


Remote ischemic preconditioning before surgery ameliorates cerebral desaturation in patients in the beach chair position during shoulder surgery. Trial Registry Number: KCT0001384 (http://cris.nih.go.kr).",2020,The remote ischemic preconditioning group had higher regional cerebral oxygen saturation just after establishment of the beach chair position (P = 0.002) and lower cerebral desaturation (P = 0.007) during operation than the control group.,"['Seventy patients scheduled for shoulder surgery were recruited', 'Operating room & postoperative recovery room, tertiary university hospital', 'patients in the beach chair position during shoulder surgery']","['remote ischemic preconditioning', 'remote ischemic preconditioning (RIPC']","['cerebral hypoperfusion', 'cytokine levels', 'regional cerebral oxygen saturation', 'Hemodynamic and laboratory values', 'lower cerebral desaturation', 'cerebral desaturation', 'regional cerebral oxygen saturation, hemodynamic values, laboratory values, and serum levels of cytokines including interleukin (IL)-1β, IL-6, IL-10 and transforming growth factor-β']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2316745', 'cui_str': 'Deckchair position'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C1695782', 'cui_str': 'Cerebral hypoperfusion'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation (observable entity)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0040691', 'cui_str': 'Animal growth regulators, transforming growth factors'}]",70.0,0.252868,The remote ischemic preconditioning group had higher regional cerebral oxygen saturation just after establishment of the beach chair position (P = 0.002) and lower cerebral desaturation (P = 0.007) during operation than the control group.,"[{'ForeName': 'Chung-Sik', 'Initials': 'CS', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Republic of Korea; Research Institute of Medical Science, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Mijung', 'Initials': 'M', 'LastName': 'Sa', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Jun', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Department of Infection and Immunology, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Piao', 'Affiliation': 'Department of Infection and Immunology, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Soo', 'Initials': 'KS', 'LastName': 'Oh', 'Affiliation': 'Department of Orthopedic Surgery, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seong-Hyop', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Republic of Korea; Department of Infection and Immunology, Konkuk University School of Medicine, Seoul, Republic of Korea; Research Institute of Medical Science, Konkuk University School of Medicine, Seoul, Republic of Korea. Electronic address: yshkim75@daum.net.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.109661']
532,31924258,Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial).,"OBJECTIVE


In a future full-scale randomised controlled trial, we plan to compare satisfaction with a standard website versus satisfaction with a participatory driven web-application. The participatory driven web-application may facilitate the delivery of targeted evidence-based advice and information to patients with low back pain in general practice (ClinicalTrials.gov Identifier: NCT03088774). This feasibility study is intended to inform a future randomised controlled trial. The aim is to report on the lessons learned from recruitment to report on reasons for loss to follow-up.
RESULTS


We recruited 12 women and 8 men from two general practices with each practice recruiting for 3 months. Full follow-up data was available in only three patients (15%). Based on the high loss to follow-up, we do not consider it feasible to conduct the full-scale confirmatory trial as planned. Modifying inclusion criteria to include only patients expressing an interest in using online health information or randomising patients directly at the general practice, supporting them in accessing the web-application, and letting patients respond with their immediate satisfaction may improve the speed of recruitment and follow-up rates. Furthermore, the participatory driven web-application can be included in a larger multi-faceted intervention, making the combined intervention seem more relevant to study participants.",2020,The participatory driven web-application may facilitate the delivery of targeted evidence-based advice and information to patients with low back pain in general practice (ClinicalTrials.gov Identifier: NCT03088774).,['12 women and 8 men from two general practices with each practice recruiting for 3\xa0months'],['standard website versus satisfaction with a participatory driven web-application'],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]",[],12.0,0.171896,The participatory driven web-application may facilitate the delivery of targeted evidence-based advice and information to patients with low back pain in general practice (ClinicalTrials.gov Identifier: NCT03088774).,"[{'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Riis', 'Affiliation': 'Center for General Practice at Aalborg University, Fyrkildevej 7, 1. Sal, 9220, Aalborg Ø, Denmark. ariis@dcm.aau.dk.'}, {'ForeName': 'Michael Skovdal', 'Initials': 'MS', 'LastName': 'Rathleff', 'Affiliation': 'Center for General Practice at Aalborg University, Fyrkildevej 7, 1. Sal, 9220, Aalborg Ø, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hartvigsen', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, Center for Muscle and Joint Health, University of Southern Denmark, Campusvej 55, 5230, Odense M, Denmark.'}, {'ForeName': 'Janus Laust', 'Initials': 'JL', 'LastName': 'Thomsen', 'Affiliation': 'Center for General Practice at Aalborg University, Fyrkildevej 7, 1. Sal, 9220, Aalborg Ø, Denmark.'}, {'ForeName': 'Tamana', 'Initials': 'T', 'LastName': 'Afzali', 'Affiliation': 'Center for General Practice at Aalborg University, Fyrkildevej 7, 1. Sal, 9220, Aalborg Ø, Denmark.'}, {'ForeName': 'Martin Bach', 'Initials': 'MB', 'LastName': 'Jensen', 'Affiliation': 'Center for General Practice at Aalborg University, Fyrkildevej 7, 1. Sal, 9220, Aalborg Ø, Denmark.'}]",BMC research notes,['10.1186/s13104-020-4894-8']
533,31927671,Effect of a balanced Korean diet on metabolic risk factors among overweight/obese Korean adults: a randomized controlled trial.,"PURPOSE


This study was to see the effects of a balanced Korean diet (BKD) on metabolic risk factors in overweight or obese Korean adults, comparing with those of a typical American diet (TAD) and a diet recommended by the 2010 Dietary Guidelines for Americans (2010DGA).
METHODS


The study was designed as a randomized crossover controlled trial, in which 61 overweight or obese volunteers were divided into six groups and each consumed the BKD, 2010DGA, and TAD in a random order for 4 weeks separated by 2-week washout intervals. Anthropometric indices, blood pressure, blood lipid content, fasting blood glucose, and blood insulin level were measured at the beginning and end of each diet period.
RESULTS


A total of 54 participants completed the trial. The BKD caused more significant reductions of body mass index (BMI) (p < 0.001), body fat percent (p < 0.001), blood total cholesterol (p < 0.001), and low-density lipoprotein (LDL) cholesterol (p = 0.007) compared with the 2010DGA or TAD (all p values for differences between diets < 0.05). All three diets significantly lowered blood triglyceride levels (p < 0.05). The BKD decreased high-density lipoprotein (HDL) cholesterol (p = 0.001) and increased fasting blood glucose (p = 0.018), whereas TAD and 2010DGA increased HDL cholesterol and did not affect blood glucose levels. Furthermore, the BKD significantly decreased the proportion of individuals with elevated total cholesterol (p < 0.001) and LDL cholesterol (p < 0.01), whereas the 2010DGA significantly reduced the number of obese individuals (p < 0.05), and the TAD decreased the number of participants with elevated triglyceride levels (p < 0.05), but increased that of those with elevated LDL cholesterol (p < 0.05).
CONCLUSIONS


The Korean diet based on dietary guidelines improved metabolic risk factors such as BMI, body fat percent, and blood lipid profiles in overweight or obese Korean adults. These results provide evidence to recommend the Korean diet for preventing various metabolic diseases.
CLINICAL TRIAL REGISTRATION


The trial was registered at the Clinical Research Information Service (CRIS) in Korea, the primary registry of the World Health Organization (WHO) international clinical trial registry platform, under number KCT0002437.",2020,"The BKD decreased high-density lipoprotein (HDL) cholesterol (p = 0.001) and increased fasting blood glucose (p = 0.018), whereas TAD and 2010DGA increased HDL cholesterol and did not affect blood glucose levels.","['overweight or obese Korean adults, comparing with those of a typical American diet (TAD) and a diet recommended by the 2010 Dietary Guidelines for Americans (2010DGA', 'overweight/obese Korean adults', '61 overweight or obese volunteers', '54 participants completed the trial', 'overweight or obese Korean adults']","['balanced Korean diet', 'balanced Korean diet (BKD']","['BKD decreased high-density lipoprotein (HDL) cholesterol', 'blood glucose levels', 'elevated triglyceride levels', 'low-density lipoprotein (LDL) cholesterol', 'number of obese individuals', 'blood triglyceride levels', 'metabolic risk factors such as BMI, body fat percent, and blood lipid profiles', 'Anthropometric indices, blood pressure, blood lipid content, fasting blood glucose, and blood insulin level', 'body mass index (BMI', 'fasting blood glucose', 'TAD and 2010DGA increased HDL cholesterol', 'metabolic risk factors', 'proportion of individuals with elevated total cholesterol', 'LDL cholesterol', 'elevated LDL cholesterol', 'body fat percent', 'blood total cholesterol']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3658297', 'cui_str': 'Nutrition Guidelines'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0853084', 'cui_str': 'Increased HDL'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",54.0,0.0632106,"The BKD decreased high-density lipoprotein (HDL) cholesterol (p = 0.001) and increased fasting blood glucose (p = 0.018), whereas TAD and 2010DGA increased HDL cholesterol and did not affect blood glucose levels.","[{'ForeName': 'Seong-Ah', 'Initials': 'SA', 'LastName': 'Kim', 'Affiliation': 'Institute of Health and Environment, Seoul National University, Seoul, 08826, Korea.'}, {'ForeName': 'Sangah', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'Department of Food and Nutrition, Chung-Ang University, Gyeonggi-do, 17546, Korea.'}, {'ForeName': 'Kyungho', 'Initials': 'K', 'LastName': 'Ha', 'Affiliation': 'Department of Public Health Science, Graduate School of Public Health, Seoul National University, Seoul, 08826, Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Hwang', 'Affiliation': 'Department of Agro-Food Resources, National Institute of Agricultural Sciences, Rural Development Administration, Wanju, Korea.'}, {'ForeName': 'Young-Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Agro-Food Resources, National Institute of Agricultural Sciences, Rural Development Administration, Wanju, Korea.'}, {'ForeName': 'Min-Sook', 'Initials': 'MS', 'LastName': 'Kang', 'Affiliation': 'Department of Agro-Food Resources, National Institute of Agricultural Sciences, Rural Development Administration, Wanju, Korea.'}, {'ForeName': 'Hyojee', 'Initials': 'H', 'LastName': 'Joung', 'Affiliation': 'Institute of Health and Environment, Seoul National University, Seoul, 08826, Korea. hjjoung@snu.ac.kr.'}]",European journal of nutrition,['10.1007/s00394-019-02141-y']
534,31925317,A randomised phase II trial of hydroxychloroquine and imatinib versus imatinib alone for patients with chronic myeloid leukaemia in major cytogenetic response with residual disease.,"In chronic-phase chronic myeloid leukaemia (CP-CML), residual BCR-ABL1+ leukaemia stem cells are responsible for disease persistence despite TKI. Based on in vitro data, CHOICES (CHlorOquine and Imatinib Combination to Eliminate Stem cells) was an international, randomised phase II trial designed to study the safety and efficacy of imatinib (IM) and hydroxychloroquine (HCQ) compared with IM alone in CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR. Sixty-two patients were randomly assigned to either arm. Treatment 'successes' was the primary end point, defined as ≥0.5 log reduction in 12-month qPCR level from trial entry. Selected secondary study end points were 24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels >2000 ng/ml. At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21). At 24 months, the 'success' rate was 20.8% higher with IM/HCQ (p = 0.059). No patients progressed. Seventeen serious adverse events, including four serious adverse reactions, were reported; diarrhoea occurred more frequently with combination. IM/HCQ is tolerable in CP-CML, with modest improvement in qPCR levels at 12 and 24 months, suggesting autophagy inhibition maybe of clinical value in CP-CML.",2020,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","['2000', 'CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR', 'patients with chronic myeloid leukaemia in major cytogenetic response with residual disease', 'Sixty-two patients']","['hydroxychloroquine and imatinib versus imatinib alone', 'IM/HCQ', 'imatinib (IM) and hydroxychloroquine (HCQ']","['MMR', 'diarrhoea', ""24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels"", 'qPCR levels', ""success' rate""]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",62.0,0.0257648,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Horne', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stobo', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mukhopadhyay', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Latif', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dixon-Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McMahon', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cony-Makhoul', 'Affiliation': 'Haematology department, CH Annecy-Genevois, Pringy, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Department of Haematology, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""Department of Haematology, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koschmieder', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'BrÜmmendorf', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Internal Medicine, University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gallipoli', 'Affiliation': 'Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Thomson', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Cong', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Clark', 'Affiliation': 'Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Milojkovic', 'Affiliation': 'Department of Haematology, Hammersmith Hospital, London, UK.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Helgason', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Foroni', 'Affiliation': 'Department of Haematology, Imperial College London, London, UK.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Nicolini', 'Affiliation': 'Hématologie Clinique and INSERM U1052, CRCL, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Holyoake', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Copland', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK. Mhairi.Copland@glasgow.ac.uk.""}]",Leukemia,['10.1038/s41375-019-0700-9']
535,31029046,Supplementation with Bifidobacterium longum Bar33 and Lactobacillus helveticus Bar13 mixture improves immunity in elderly humans (over 75 years) and aged mice.,"OBJECTIVE


Aging induces several physiologic and immune changes. The usefulness of probiotics in ameliorating age-related disorders remains largely unexplored. The aim of this study was to evaluate the effectiveness of a Bifidobacterium longum Bar33 and Lactobacillus helveticus Bar13 mixture in improving the physiologic status and immunity of older adults (over 75 years). Furthermore, the possible role of such mixture in ameliorating gut immunity in aged mice was investigated.
METHODS


A randomized, double-blind, placebo-controlled trial was conducted with 98 adults (84.6 ± 7.8 y), supplemented for 30 d with a biscuit containing a probiotic mixture of B. longum Bar33 and L. helveticus Bar13 (1:1), or no probiotics, as placebo. Blood was collected for analysis of biochemical parameters, lymphocyte subpopulations, natural killer activity, and cytokine release. Aged Balb/c mice received the same probiotic mixture or placebo daily for 28 d, then blood and intestinal lymphocyte subpopulations were analyzed.
RESULTS


The probiotic mixture ameliorated immune response in older adults by increasing naive, activated memory, regulatory T cells, B cells, and natural killer activity and decreasing memory T cells compared with placebo (P < 0.05). The biochemical parameters did not change after probiotic supplementation. In the gut of old mice, the two probiotics modulated cells crucial for gut immune homeostasis by increasing regulatory T (Treg and Tr1) and decreasing γδ T cells compared with control mice (P < 0.05). In addition, B cells increased in the gut and blood of probiotic-treated mice.
CONCLUSION


Results from the present study data indicated that B. longum Bar33 and L. helveticus Bar13 improve immune function at intestinal and peripheral sites in aging.",2019,"The probiotic mixture ameliorated immune response in older adults by increasing naive, activated memory, regulatory T cells, B cells, and natural killer activity and decreasing memory T cells compared with placebo (P < 0.05).","['older adults (over 75 years', '98 adults (84.6 ± 7.8 y), supplemented for 30 d with a', 'older adults', 'elderly humans (over 75 years) and aged mice']","['Bifidobacterium longum Bar33 and Lactobacillus helveticus Bar13 mixture', 'probiotic mixture or placebo', 'placebo', 'biscuit containing a probiotic mixture of B. longum Bar33 and L. helveticus Bar13 (1:1), or no probiotics, as placebo']","['immune response', 'γδ T cells', 'naive, activated memory, regulatory T cells, B cells, and natural killer activity and decreasing memory T cells', 'biochemical parameters, lymphocyte subpopulations, natural killer activity, and cytokine release']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026809', 'cui_str': 'Mice'}]","[{'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0317592', 'cui_str': 'Lactobacillus helveticus'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1564227', 'cui_str': 'Kelfizine'}]","[{'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",98.0,0.275889,"The probiotic mixture ameliorated immune response in older adults by increasing naive, activated memory, regulatory T cells, B cells, and natural killer activity and decreasing memory T cells compared with placebo (P < 0.05).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Finamore', 'Affiliation': 'CREA Research Centre for Food and Nutrition, Rome, Italy. Electronic address: Alberto.finamore@crea.gov.it.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Roselli', 'Affiliation': 'CREA Research Centre for Food and Nutrition, Rome, Italy.'}, {'ForeName': 'LorenzoMaria', 'Initials': 'L', 'LastName': 'Donini', 'Affiliation': 'Sapienza University, Department of Experimental Medicine, Rome, Italy.'}, {'ForeName': 'Dr Elisa', 'Initials': 'DE', 'LastName': 'Brasili', 'Affiliation': 'CREA Research Centre for Food and Nutrition, Rome, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Rami', 'Affiliation': 'CREA Research Centre for Food and Nutrition, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Carnevali', 'Affiliation': 'R&D Advanced Research Microbiology, Barilla G&R f.lli SpA, Parma, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Mistura', 'Affiliation': 'CREA Research Centre for Food and Nutrition, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Pinto', 'Affiliation': 'Sapienza University, Department of Experimental Medicine, Rome, Italy.'}, {'ForeName': 'AnnaMaria', 'Initials': 'A', 'LastName': 'Giusti', 'Affiliation': 'Sapienza University, Department of Experimental Medicine, Rome, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Mengheri', 'Affiliation': 'CREA Research Centre for Food and Nutrition, Rome, Italy.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.02.005']
536,31924365,Assessment of preoperative noninvasive ventilation before lung cancer surgery: The preOVNI randomized controlled study.,"OBJECTIVES


The preOVNI study was a randomized, controlled, open-label study that investigated whether preoperative noninvasive ventilation (NIV) could reduce postoperative complications after lung cancer surgery.
METHODS


Adult patients with planned lung cancer resection and with at least 1 cardiac or respiratory comorbidity were included and randomly assigned to preoperative NIV (at least 7 days and 4 h/day) or no NIV. The primary endpoint was the rate of postoperative protocol-defined complications.
RESULTS


Three hundred patients were included. In the NIV group, the median NIV duration was 8 days. No difference of postoperative complication rates was evidenced: 42.6% in NIV group and 44.8% in no-NIV group (P = .75). The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08). The type of surgery (open or minimally invasive) did not impact these results after multivariable analysis.
CONCLUSIONS


No benefit was evidenced for preoperative NIV before lung cancer surgery. Further studies should determine the optimal perioperative management to decrease the rate of postoperative complications.",2020,"The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08).","['before lung cancer surgery', 'Three hundred patients were included', 'Adult patients with planned lung cancer resection and with at least 1 cardiac or respiratory comorbidity', 'after lung cancer surgery']","['preoperative noninvasive ventilation', 'preoperative noninvasive ventilation (NIV']","['rate of postoperative protocol-defined complications', 'postoperative complication rates', 'postoperative complications', 'rate of pneumonia', 'median NIV duration']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",300.0,0.134838,"The rate of pneumonia was greater in no-NIV group compared with the NIV group, but statistical significance was not achieved (28.0 vs 37.7%, respectively; P = .08).","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Paleiron', 'Affiliation': 'Respiratory Disease Unit, HIA Sainte Anne, Toulon, France; Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France. Electronic address: nicolas.paleiron@intradef.gouv.fr.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Grassin', 'Affiliation': 'Respiratory Disease Unit, HIA Clermont Tonnerre, Brest, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lancelin', 'Affiliation': 'Thoracic Surgery Unit, Clinique du Grand Large, Brest, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tromeur', 'Affiliation': 'Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Margery', 'Affiliation': 'Respiratory Disease Unit, HIA Percy, Clamart, France.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Natale', 'Affiliation': 'Respiratory Disease Unit, HIA Sainte Anne, Toulon, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Département de médecine interne et pneumologie, GETBO EA3878 CIC INSERM 1412, CHU Cavale Blanche, Brest, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.09.193']
537,31925579,"Flurbiprofen axetil for postoperative analgesia in upper abdominal surgery: a randomized, parallel controlled, double-blind, multicenter clinical study.","PURPOSE


To investigate the efficacy and safety of flurbiprofen axetil in postoperative analgesia in upper abdominal surgery.
METHODS


This was a multicenter, randomized, positive drug parallel controlled double-blind clinical study. Patients undergoing upper abdominal surgery were randomly divided to receive flurbiprofen axetil or tramadol. The VAS pain scores at rest and on coughing (pulmonary function training) were assessed immediately before drug usage (T1) to evaluate the efficacy of postoperative analgesia. Repeat assessment of the VAS was performed after T1. The timing of the recovery of the gastrointestinal function and the preoperative and postoperative IL-6, cortisol, and blood glucose levels were recorded as secondary endpoints. Vital signs and the occurrence of adverse reactions were evaluated for the assessment of safety.
RESULTS


A total of 240 patients were enrolled in the current study; 119 used flurbiprofen axetil for postoperative analgesia. The VAS scores at rest and on coughing did not differ between the two groups to a statistically significant extent (P > 0.05). However, the reduction of the VAS score at rest in the flurbiprofen axetil group was greater than that in the tramadol group at 4-24 h after T1. The reduction of the VAS score on coughing at 8 h after T1 was greater in the flurbiprofen axetil group. The incidence of adverse reactions was significantly lower in the flurbiprofen axetil group, with only one adverse reaction recorded. In contrast, 18 adverse reactions were reported in the tramadol group.
CONCLUSION


Flurbiprofen axetil showed superior efficacy to tramadol in early postoperative analgesia after upper abdominal surgery. Flurbiprofen axetil was associated with a significantly lower incidence of adverse reactions in comparison to tramadol.",2020,Flurbiprofen axetil showed superior efficacy to tramadol in early postoperative analgesia after upper abdominal surgery.,"['Patients undergoing upper abdominal surgery', '240 patients were enrolled in the current study; 119 used', 'early postoperative analgesia after upper abdominal surgery', 'upper abdominal surgery']","['flurbiprofen axetil or tramadol', 'flurbiprofen axetil', 'tramadol', 'Flurbiprofen axetil']","['adverse reactions', 'VAS pain scores at rest and on coughing (pulmonary function training', 'efficacy and safety', 'VAS scores at rest and on coughing', 'VAS score', 'VAS score on coughing', 'Vital signs and the occurrence of adverse reactions', 'incidence of adverse reactions', 'preoperative and postoperative IL-6, cortisol, and blood glucose levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}]",240.0,0.0513386,Flurbiprofen axetil showed superior efficacy to tramadol in early postoperative analgesia after upper abdominal surgery.,"[{'ForeName': 'Run-Dong', 'Initials': 'RD', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Anhui No. 2 Provincial People's Hospital, Hefei, Anhui, People's Republic of China.""}, {'ForeName': 'Xu-Ren', 'Initials': 'XR', 'LastName': 'Sheng', 'Affiliation': ""Department of Liver Surgery, The First Affiliated Hospital of USTC, 17 Lujiang Road, Luyang, Hefei, Anhui, 230001, People's Republic of China.""}, {'ForeName': 'Wen-Xian', 'Initials': 'WX', 'LastName': 'Guan', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, People's Republic of China.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, People's Republic of China.""}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': ""Hepatological Surgery Department, Hunan Provincial People's Hospital, The First Hospital Affiliated with Hunan Normal University, Changsha, People's Republic of China.""}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': ""The Basic Surgical, Union Hospital Affiliated with Fujian Medical University, Fuzhou, People's Republic of China.""}, {'ForeName': 'He-Guang', 'Initials': 'HG', 'LastName': 'Huang', 'Affiliation': ""The Basic Surgical, Union Hospital Affiliated with Fujian Medical University, Fuzhou, People's Republic of China.""}, {'ForeName': '', 'Initials': '', 'LastName': 'Ning-Li', 'Affiliation': ""Intestinal Microenvironment Treatment Center, Tenth People's Hospital of Tongji University, Shanghai, People's Republic of China.""}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Jia', 'Affiliation': ""Department of Liver Surgery, The First Affiliated Hospital of USTC, 17 Lujiang Road, Luyang, Hefei, Anhui, 230001, People's Republic of China. jwd19680@sina.com.""}]",Surgery today,['10.1007/s00595-019-01951-1']
538,31918639,"Effects of a Growth Mindset of Personality on Emerging Adults' Defender Self-Efficacy, Moral Disengagement, and Perceived Peer Defending.","This study investigated the effects of a brief educational exercise aimed to promote a growth mindset of personality (the belief that personality traits are malleable) on outcomes linked to peer defending. Undergraduates ( N  = 60) were randomly assigned to complete a learning task designed to foster a growth mindset of personality or to a matching control task. They then read a vignette of a college student victimized by peers and completed paper-and-pencil measures of defender self-efficacy, moral disengagement, and perceived defender behavior, followed by a brief manipulation check. The experimental manipulation was successful, and participants who completed the growth mindset of personality intervention reported higher defender self-efficacy, lower moral disengagement, and higher perceived defending behavior. There was also a significant indirect effect of the experimental manipulation on perceived defending via self-efficacy, suggesting that a growth mindset of personality may influence peer defending through gains in defender self-efficacy. Implications are discussed for bullying prevention, with emphasis on programming for emerging adults at college.",2020,"There was also a significant indirect effect of the experimental manipulation on perceived defending via self-efficacy, suggesting that a growth mindset of personality may influence peer defending through gains in defender self-efficacy.",['Undergraduates ( N  = 60'],"['learning task designed to foster a growth mindset of personality or to a matching control task', 'educational exercise']",[],[],"[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],,0.0168131,"There was also a significant indirect effect of the experimental manipulation on perceived defending via self-efficacy, suggesting that a growth mindset of personality may influence peer defending through gains in defender self-efficacy.","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Derr', 'Affiliation': 'Arcadia University, Glenside, PA, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Morrow', 'Affiliation': 'Arcadia University, Glenside, PA, USA.'}]",Journal of interpersonal violence,['10.1177/0886260517713716']
539,31136052,Ten-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection.,"BACKGROUND & AIMS


Tenofovir disoproxil fumarate (TDF) is a first-line treatment for chronic hepatitis B (CHB). We aimed to describe the efficacy and safety profiles of TDF treatment for up to 10 years in a well-described cohort of CHB patients.
METHODS


Hepatitis B e antigen (HBeAg)-negative and HBeAg-positive patients from two randomised, double-blind trials (ClinicalTrials.gov: NCT00117676 and NCT00116805) completed 48 weeks of randomised treatment with TDF or adefovir dipivoxil. A subset of these patients was then eligible to receive open-label TDF treatment for up to 10 years. At Year 10, patients were assessed for virological suppression, alanine aminotransferase (ALT) normalisation, serological response, safety and tolerability.
RESULTS


Of 641 randomised and treated patients, 585 (91%) entered the open-label extension phase with 203 (32%) patients completing Year 10 of the study. At Year 10, 118/118 (100%) of HBeAg-negative patients and 78/80 (98%) of HBeAg-positive patients with available data achieved hepatitis B virus (HBV) DNA < 69 IU/mL, while 88/106 (83%) and 60/77 (78%) patients achieved ALT normalisation, respectively. Of the 23 patients with HBeAg status available at Year 10, 12 (52%) and six (27%) experienced HBeAg loss and seroconversion, respectively. No resistance to TDF was documented up to Year 10. In the period between Year 8 and Year 10, the safety profile of TDF was similar to previous reports, with few patients experiencing renal- or bone-related adverse events.
CONCLUSIONS


Over 10 years, TDF had a favourable safety profile, was well tolerated, and resulted in continued maintenance of virological suppression with no documented resistance.",2019,"Over 10 years, TDF had a favourable safety profile, was well tolerated, and resulted in continued maintenance of virological suppression with no documented resistance.","['chronic hepatitis B (CHB', 'up to 10\xa0years in a well-described cohort of CHB patients', 'Of 641', 'randomised and treated patients, 585 (91%) entered the open-label extension phase with 203 (32%) patients completing Year 10 of the study', 'chronic hepatitis B virus infection', 'Hepatitis B e antigen ']","['Tenofovir disoproxil fumarate (TDF', 'TDF or adefovir dipivoxil', 'TDF', 'tenofovir disoproxil fumarate treatment', 'open-label TDF']","['HBeAg loss and seroconversion', 'efficacy and safety profiles', 'virological suppression', 'virological suppression, alanine aminotransferase (ALT) normalisation, serological response, safety and tolerability', 'hepatitis B virus (HBV) DNA', 'safety profile of TDF']","[{'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0540694', 'cui_str': 'adefovir dipivoxil'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0205473', 'cui_str': 'Serologic (qualifier value)'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}]",23.0,0.106675,"Over 10 years, TDF had a favourable safety profile, was well tolerated, and resulted in continued maintenance of virological suppression with no documented resistance.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Marcellin', 'Affiliation': 'Viral Hepatitis Research Unit, Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wong', 'Affiliation': 'Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Sievert', 'Affiliation': 'Gastroenterology and Hepatology Unit, Monash Health and Monash University, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Buggisch', 'Affiliation': 'Liver Unit, IFI-Institute for Interdisciplinary Medicine, Asklepios Klinik St Georg, Hamburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Liver Unit, IFI-Institute for Interdisciplinary Medicine, Asklepios Klinik St Georg, Hamburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Flisiak', 'Affiliation': 'Department of Infectious Diseases and Hepatology, Medical University Bialystok, Bialystok, Poland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kaita', 'Affiliation': 'Viral Hepatitis Investigative Unit, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Zahari', 'Initials': 'Z', 'LastName': 'Krastev', 'Affiliation': 'Clinic of Gastroenterology, St Ivan Rilsky University Hospital, Medical University, Sofia, Bulgaria.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Liver Unit, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Cathcart', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Crans', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Marjoleine', 'Initials': 'M', 'LastName': 'Op den Brouw', 'Affiliation': 'Gilead Sciences Europe Ltd, Uxbridge, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Jump', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Flaherty', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buti', 'Affiliation': ""Liver Unit, Hospital Universitario Vall d'Hebron and CIBEREHD del Instituto Carlos III, Barcelona, Spain.""}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14155']
540,31783231,The Labour Progression Study (LaPS): Duration of labour following Zhang's guideline and the WHO partograph - A cluster randomised trial.,"OBJECTIVE


To investigate labour duration in different phases of labour when adhering to Zhang's guideline for labour progression compared with the WHO partograph.
DESIGN


A secondary analysis of a cluster randomised controlled trial.
SETTING


Fourteen Norwegian birth care units, each with more than 500 deliveries per year constituted the clusters.
PARTICIPANTS


A total of 7277 nulliparous women with singleton foetus in a cephalic presentation and spontaneous onset of labour at term were included.
INTERVENTION


Seven clusters were randomised to the intervention group that adhered to Zhang's guideline (n = 3972) and seven to the control group that adhered to the WHO partograph (n = 3305) for labour progression.
MEASUREMENTS


The duration of labour from the first registration of cervical dilatation (≥ 4 cm) to the delivery of the baby and the duration of the first and second stages of labour; the time-to-event analysis was used to compare the duration of labour between the two groups after adjusting for baseline covariates.
FINDINGS


The adjusted median duration of labour was 7.0 h in the Zhang group, compared with 6.2 h in the WHO group; the median difference was 0.84 h with 95% confidence interval [CI] (0.2-1.5). The adjusted median duration of the first stage was 5.6 h in the Zhang group compared with 4.9 h in the WHO group; the median difference was 0.66 h with 95% CI (0.1-1.2). The corresponding adjusted median duration of the second stage was 88 and 77 min; the median difference was 0.18 h with 95% CI (0.1-0.3).
KEY CONCLUSIONS


The women who adhered to Zhang's guideline had longer overall duration and duration of the first and second stages of labour than women who adhered to the WHO partograph.
IMPLICATIONS FOR PRACTICE


Understanding the variations in the duration of labour is of great importance, and the results offer useful insights into the different labour progression guidelines, which can inform clinical practice.",2020,The adjusted median duration of the first stage was 5.6 h in the Zhang group compared with 4.9 h in the WHO group; the median difference was 0.66 h with 95% CI (0.1-1.2).,"['Fourteen Norwegian birth care units, each with more than 500 deliveries per year constituted the clusters', 'A total of 7277 nulliparous women with singleton foetus in a cephalic presentation and spontaneous onset of labour at term were included']","[""intervention group that adhered to Zhang's guideline (n\xa0=\xa03972) and seven to the control group that adhered to the WHO partograph""]","['Labour Progression Study (LaPS', 'overall duration and duration of the first and second stages of labour', 'adjusted median duration of labour', 'adjusted median duration of the first stage', 'duration of labour']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2979973'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor (observable entity)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}]",500.0,0.114265,The adjusted median duration of the first stage was 5.6 h in the Zhang group compared with 4.9 h in the WHO group; the median difference was 0.66 h with 95% CI (0.1-1.2).,"[{'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Dalbye', 'Affiliation': 'Department of Obstetrics and Gynaecology, Østfold Hospital Trust, Grålum, Norway; Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway. Electronic address: rebecka.dalbye@so-hf.no.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Blix', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Kathrine Frey', 'Initials': 'KF', 'LastName': 'Frøslie', 'Affiliation': ""Norwegian National Advisory Unit on Women's Health, Oslo University Hospital, Oslo, Norway.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Torbjørn Moe', 'Initials': 'TM', 'LastName': 'Eggebø', 'Affiliation': 'National Centre for Fetal Medicine, Trondheim University Hospital (St Olavs Hospital), Trondheim, Norway; Department of Obstetrics and Gynaecology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Inge Christoffer', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Research Support Services, Clinical Trial Unit, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Rozsa', 'Affiliation': 'Department of Obstetrics and Gynaecology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital of North Norway, Norway; Department of Clinical Medicine, Faculty of Health Sciences, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Bernitz', 'Affiliation': 'Department of Obstetrics and Gynaecology, Østfold Hospital Trust, Grålum, Norway; Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway.'}]",Midwifery,['10.1016/j.midw.2019.102578']
541,31919583,Modest improvement in CVD risk markers in older adults following quinoa (Chenopodium quinoa Willd.) consumption: a randomized-controlled crossover study with a novel food product.,"PURPOSE


To investigate the effect of consuming quinoa biscuits on markers of CVD risk over 4 weeks in free-living older adults.
METHODS


A randomized-controlled, double-blind crossover trial was conducted in which consenting healthy adults aged 50-75 years (n = 40) consumed 15 g quinoa biscuits (60 g quinoa flour/100 g) or control iso-energetic biscuits (made using wheat flour) daily for 28 consecutive days (4 weeks), in addition to their normal diet. Following a 6-week washout, participants consumed the alternate biscuit for a final 4 weeks. Anthropometry and fasted blood samples were obtained before and after each intervention period.
RESULTS


At the beginning of the trial, mean ± SD total cholesterol concentrations were 6.02 ± 1.22 mmol/L (3.7-9.2 mmol/L); 33 participants (82.5%) had high cholesterol (> 5 mmol/L). No participants were lost to follow-up and there were no changes in habitual dietary intakes or levels of physical activity between each 4-week intervention period. Significantly greater decreases in total and LDL cholesterol concentrations (- 0.30 ± 0.58 and - 0.25 ± 0.38 mmol/L, respectively), TC: HDL ratio (- 0.11 ± 0.30), weight (- 0.61 ± 0.89 kg) and BMI (- 0.22 ± 0.34 kg/m 2 ) were apparent following consumption of the quinoa versus control biscuits (all P < 0.05). Changes in triglycerides, HDL cholesterol, or PUFA or CRP concentrations were not significant between treatment groups.
CONCLUSION


Consumption of novel quinoa biscuits produced small, but favorable changes in body weight, BMI, and circulating cholesterol concentrations, all of which may contribute to lowered CVD risk in older adults.",2020,No participants were lost to follow-up and there were no changes in habitual dietary intakes or levels of physical activity between each 4-week intervention period.,"['older adults following quinoa (Chenopodium quinoa Willd', 'consenting healthy adults aged 50-75\xa0years (n\u2009=\u200940', 'free-living older adults', 'older adults']","['consumed 15\xa0g quinoa biscuits (60\xa0g quinoa flour/100\xa0g) or control iso-energetic biscuits (made using wheat flour', 'consuming quinoa biscuits']","['BMI', 'TC: HDL ratio', 'weight', 'CVD risk markers', 'habitual dietary intakes or levels of physical activity', 'total and LDL cholesterol concentrations', 'mean\u2009±\u2009SD total cholesterol concentrations', 'CVD risk', 'triglycerides, HDL cholesterol, or PUFA or CRP concentrations', 'body weight, BMI, and circulating cholesterol concentrations']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1504609', 'cui_str': 'Quinoa'}, {'cui': 'C0453354', 'cui_str': 'Chenopodium quinoa'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1504609', 'cui_str': 'Quinoa'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour (substance)'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",33.0,0.0665714,No participants were lost to follow-up and there were no changes in habitual dietary intakes or levels of physical activity between each 4-week intervention period.,"[{'ForeName': 'L Kirsty', 'Initials': 'LK', 'LastName': 'Pourshahidi', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, BT52 1SA, UK.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Caballero', 'Affiliation': 'Regional Centre for Studies in Food and Health (CREAS), Avenida Universidad N°330, Valparaiso, Chile.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Osses', 'Affiliation': 'Regional Centre for Studies in Food and Health (CREAS), Avenida Universidad N°330, Valparaiso, Chile.'}, {'ForeName': 'Barry W', 'Initials': 'BW', 'LastName': 'Hyland', 'Affiliation': 'School of Biomedical Sciences, Ulster University, Coleraine, BT52 1SA, UK.'}, {'ForeName': 'Nigel G', 'Initials': 'NG', 'LastName': 'Ternan', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, BT52 1SA, UK.'}, {'ForeName': 'Chris I R', 'Initials': 'CIR', 'LastName': 'Gill', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, BT52 1SA, UK. c.gill@ulster.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-019-02169-0']
542,31900579,Time course of tolerance to adverse effects associated with the ingestion of a moderate dose of caffeine.,"PURPOSE


This study aimed to identify and describe the time course of tolerance to the most common caffeine-induced side effects.
METHODS


Eleven participants took part in a crossover, double-blind placebo-controlled experimental design. In one phase, participants ingested 3 mg/kg/day of caffeine for 20 days, while in another phase, they ingested a placebo. Resting heart rate and blood pressure were measured three times per week during each 20-day phase and a quantitative survey was used to categorise the magnitude of side effects.
RESULTS


In the pairwise comparison with the placebo, the ingestion of caffeine increased systolic (+ 7.8 ± 10.1%, P < 0.05) and diastolic blood pressure (+ 6.4 ± 12.9% P < 0.05) for the first 8 days of ingestion, but then this effect became attenuated for both outcomes (on day 20, - 1.1 ± 4.3% and + 0.9 ± 9.6%, respectively). The ingestion of caffeine did not affect heart rate at any time point. Caffeine increased the feelings of nervousness and vigour and the rating of gastrointestinal complaints, insomnia and diuresis at several time points in the treatment (P < 0.05) and they did not disappear after 20 days of ingestion.
CONCLUSIONS


The daily intake of 3 mg/kg of caffeine induced a meaningful elevation in arterial blood pressure that disappeared after 8 days. However, other caffeine-induced effects such as increased nervousness and vigour, irritability, insomnia and diuresis remained after 20 days of consecutive caffeine ingestion. Although there was clear tolerance to the effect of caffeine on blood pressure, the persistence of other side effects suggests the inconvenience of maintaining a chronic caffeine intake, at least at the dose of 3 mg/kg/day.",2020,"Caffeine increased the feelings of nervousness and vigour and the rating of gastrointestinal complaints, insomnia and diuresis at several time points in the treatment (P < 0.05) and they did not disappear after 20 days of ingestion.
","['Eleven participants took part in a crossover, double-blind']","['placebo', 'Caffeine', 'caffeine']","['feelings of nervousness and vigour and the rating of gastrointestinal complaints, insomnia and diuresis at several time points', 'heart rate', 'Resting heart rate and blood pressure', 'systolic', 'nervousness and vigour, irritability, insomnia and diuresis', 'arterial blood pressure', 'diastolic blood pressure', 'blood pressure']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",11.0,0.114515,"Caffeine increased the feelings of nervousness and vigour and the rating of gastrointestinal complaints, insomnia and diuresis at several time points in the treatment (P < 0.05) and they did not disappear after 20 days of ingestion.
","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruiz-Moreno', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Lara', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Salinero', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Brito de Souza', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ordovás', 'Affiliation': 'USDA ARS, Human Nutrition Research Center On Aging At Tufts University, Boston, MA, 02111, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, C/Camino del Molino, s/n, 28943, Fuenlabrada, Spain. juan.delcoso@urjc.es.'}]",European journal of nutrition,['10.1007/s00394-019-02167-2']
543,31539053,Energy Availability Is Associated With Luteinizing Hormone Pulse Frequency and Induction of Luteal Phase Defects.,"OBJECTIVE


Determine the interrelations between reductions in energy availability (EA), luteinizing hormone (LH) pulse frequency, and the induction of menstrual disturbances in previously sedentary, ovulatory women.
METHODS


Secondary analysis of a randomized controlled trial consisting of a 3-month controlled diet and supervised exercise program. EA was calculated daily by measured energy intake (kcal) and exercise energy expenditure (kcal) normalized to fat-free mass (kg) and averaged during baseline and each of 3 intervention menstrual cycles. Blood samples were obtained every 10 minutes for 24 hours in the early follicular phase before the intervention and after 3 months of diet and exercise (n = 14). LH pulse dynamics were assessed by Cluster. Linear mixed models determined whether EA predicts LH pulse frequency and LH pulse frequency predicts luteal phase defects (LPDs).
RESULTS


Subjects were 20 ± 1 years old, 165.1 ± 1.4 cm tall, and weighed 58.9 ± 1.5 kg. LH pulse frequency decreased from 0.82 ± 0.06 pulses/h to 0.63 ± 0.09 pulses/h (P = 0.048) as a result of the intervention which produced modest (-3.2 ± 0.6 kg) weight loss. EA, averaged across a menstrual cycle, predicted LH pulse frequency (P = 0.003) such that a single-unit decrease in EA was associated with a 0.017 pulses/h decrease in LH pulse frequency. LH pulse frequency in cycles with LPDs was 49% of that observed in cycles with no menstrual disturbances and for every 0.1-unit decrease in LH pulse frequency, the odds of having an LPD were 22× greater than having an optimal ovulatory cycle (P = 0.01).
CONCLUSIONS


Modest reductions in EA over a prolonged period are associated with decreased LH pulse frequency and the induction of menstrual disturbances.",2020,LH pulse frequency decreased from 0.82±0.06pulses,"['Subjects were 20±1yrs old 165.1±1.4cm tall and weighed 58.9±1.5kg', 'previously sedentary, ovulatory women']",['controlled diet and supervised exercise program'],"['energy intake (kcal) and exercise energy expenditure (kcal) normalized to fat-free mass (kg', 'EA predicts LH pulse frequency and LH pulse frequency predicts luteal phase defects (LPDs', 'energy availability (EA), LH pulse frequency, and the induction of menstrual disturbances', 'LH pulse dynamics', 'LH pulse frequency']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0404576', 'cui_str': 'Luteal phase defect (disorder)'}, {'cui': 'C0025345', 'cui_str': 'Menstruation Disorders'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",,0.0510295,LH pulse frequency decreased from 0.82±0.06pulses,"[{'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Koltun', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'De Souza', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Scheid', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}, {'ForeName': 'Nancy I', 'Initials': 'NI', 'LastName': 'Williams', 'Affiliation': ""Women's Health and Exercise Laboratory, Department of Kinesiology, The Pennsylvania State University, University Park, Pennsylvania.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz030']
544,31544290,Novel thulium fiber laser for endoscopic enucleation of the prostate: A prospective comparison with conventional transurethral resection of the prostate.,"OBJECTIVE


To compare the efficacy and safety of a novel thulium fiber laser for endoscopic enucleation of the prostate with monopolar transurethral resection of the prostate in patients with smaller glands (<80 cc).
METHODS


A total of 51 patients underwent thulium fiber laser enucleation of the prostate, and 52 patients underwent monopolar transurethral resection of the prostate. All patients were assessed preoperatively, and at 3, 6, and 12 months postoperatively (International Prostate Symptom Score, maximum urine flow rate, International Prostate Symptom Score-quality of life). Preoperative prostate volumes and prostate-specific antigen levels were comparable (P = 0.543 and P = 0.078, respectively). The complications were graded according to the Clavien classification.
RESULTS


Mean surgery time was longer in the thulium fiber laser enucleation of the prostate group (46.6 ± 10.2 vs 39.9 ± 8.6 min, P < 0.001), while catheterization and hospital stay were greater in the transurethral resection of the prostate group (P < 0.001). At 12 months, there were no differences in functional outcomes (International Prostate Symptom Score, maximum urine flow rate). Despite comparable prostate volumes at 12 months (P = 0.864), the prostate-specific antigen level in the thulium fiber laser enucleation of the prostate group (0.5 ± 0.5 ng/mL) was lower than in the transurethral resection of the prostate group (1.1 ± 1.0 ng/mL; P < 0.001). Hemoglobin and serum sodium decrease was lower in the thulium fiber laser enucleation of the prostate group (1.01 ± 0.4 g/dL and 1.1 ± 1.1 mmol/L) than in the transurethral resection of the prostate group (1.8 ± 0.8 g/dL and 4.1 ± 1.1 mmol/L; P < 0.001). Urinary incontinence rates at 12 months were comparable (P = 0.316).
CONCLUSIONS


Thulium fiber laser enucleation of the prostate with novel thulium fiber laser in patients with smaller prostate glands (<80 cc) is comparable to transurethral resection of the prostate in voiding parameters improvement and complication rates. At the same time, the technique allows for a more substantial prostate-specific antigen decrease, indicating more complete removal of adenoma.",2019,"< 0.001), while catheterization and hospital stay were greater in the transurethral resection of the prostate group (P < 0.001).","['patients with smaller glands (<80\xa0cc', '51 patients underwent', 'endoscopic enucleation of the prostate']","['Novel thulium fiber laser', 'conventional transurethral resection of the prostate', 'monopolar transurethral resection of the prostate', 'monopolar transurethral resection', 'novel thulium fiber laser', 'thulium fiber laser enucleation', 'Thulium fiber laser enucleation']","['functional outcomes (International Prostate Symptom Score, maximum urine flow rate', 'efficacy and safety', 'Urinary incontinence rates', 'Preoperative prostate volumes and prostate-specific antigen levels', 'catheterization and hospital stay', 'prostate-specific antigen level', 'Hemoglobin and serum sodium decrease', 'International Prostate Symptom Score, maximum urine flow rate, International Prostate Symptom Score-quality of life', 'Mean surgery time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}]","[{'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0042037'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4048754', 'cui_str': 'Serum sodium decreased'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0185111,"< 0.001), while catheterization and hospital stay were greater in the transurethral resection of the prostate group (P < 0.001).","[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Enikeev', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Netsch', 'Affiliation': 'Department of Urology, Asklepios Hospital Barmbek, Hamburg, Germany.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Rapoport', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Magomed', 'Initials': 'M', 'LastName': 'Gazimiev', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Laukhtina', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Olesya', 'Initials': 'O', 'LastName': 'Snurnitsyna', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Alekseeva', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'Department of Urology, Asklepios Hospital Barmbek, Hamburg, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Taratkin', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Glybochko', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14115']
545,31775084,The effect of structured empathy education on empathy competency of undergraduate nursing interns: A quasi-experimental study.,"BACKGROUND


Empathy is a crucial element in fostering a positive relationship between nurses and patients. Recent research indicates that the degree of empathy in nursing students declines as they gain education or experience. A number of teaching strategies have been used to improve nursing students' empathy competence levels. However, little is currently known about how empathy is best taught or enhanced in senior nursing students in China.
OBJECTIVES


To implement a structured empathy educational program as developed from the Delphi technique, as well as to evaluate its effects on empathy competence among undergraduate nursing interns.
DESIGN


This study is quasi-experimental, with two-group comparison.
PARTICIPANTS


Undergraduate nursing students in their fourth year (n = 118) were recruited from an affiliated teaching hospital in Wuhan, Central Part of China, between January 2018 and March 2018.
METHODS


A convenience sample of 118 undergraduate nursing interns were recruited from a teaching hospital in Wuhan and assigned to either the intervention or the control group according to their preference. Participants in the intervention group had received a 2-week, 12-hour structured empathy-related educational program (two sessions per week, 3 h per session), whereas the control group received no intervention. The Jefferson Scale of Empathy-Health Providers (JSE-HPs) was used to assess students' empathy levels before and after the intervention.
RESULTS


An independent samples t-test revealed that scores of empathy competence levels in the intervention group were significantly higher than those in the control group following the intervention. Three domains of empathy competence level were also significantly higher in the intervention group after the two weeks' training relative to the control group, namely: perspective taking, compassionate care, and standing in the patient's shoes.
CONCLUSIONS


This modified empathy educational program may prove beneficial in improving the empathy competence level of undergraduate nursing interns.",2020,"Three domains of empathy competence level were also significantly higher in the intervention group after the two weeks' training relative to the control group, namely: perspective taking, compassionate care, and standing in the patient's shoes.
","['Undergraduate nursing students in their fourth year (n\xa0=\xa0118) were recruited from an affiliated teaching hospital in Wuhan, Central Part of China, between January 2018 and March 2018', 'undergraduate nursing interns', '118 undergraduate nursing interns were recruited from a teaching hospital in Wuhan and assigned to either the intervention or the control group according to their preference', 'senior nursing students in China']","['structured empathy education', 'structured empathy educational program', '12-hour structured empathy-related educational program', 'control group received no intervention']","['scores of empathy competence levels', 'empathy competence level']","[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0239255,"Three domains of empathy competence level were also significantly higher in the intervention group after the two weeks' training relative to the control group, namely: perspective taking, compassionate care, and standing in the patient's shoes.
","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Faculty of Nursing, Wuhan University School of Health Sciences, Wuhan 430071, PR China.'}, {'ForeName': 'Ya-Li', 'Initials': 'YL', 'LastName': 'Zhu', 'Affiliation': 'Minda Hospital, Hubei Minzu University, Enshi 445000, PR China.'}, {'ForeName': 'Bi-Ying', 'Initials': 'BY', 'LastName': 'Xia', 'Affiliation': 'Faculty of Nursing, Wuhan University School of Health Sciences, Wuhan 430071, PR China.'}, {'ForeName': 'Ya-Wei', 'Initials': 'YW', 'LastName': 'Li', 'Affiliation': 'Faculty of Nursing, Wuhan University School of Health Sciences, Wuhan 430071, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Nursing, Wuhan University School of Health Sciences, Wuhan 430071, PR China. Electronic address: junz@whu.edu.cn.'}]",Nurse education today,['10.1016/j.nedt.2019.104296']
546,31898550,Exploring the decoy effect to guide tobacco treatment choice: a randomized experiment.,"OBJECTIVES


Guidelines recommend that smokers participate in four or more counseling sessions when trying to quit, but smokers rarely engage in multiple sessions. The ""decoy effect"" is a cognitive bias that can cause consumer preferences for a ""target"" product to change when presented with a similar but inferior product (a ""decoy""). This study tested the use of a decoy to guide smokers' selection of a target number of counseling sessions. During an online survey, adult tobacco users (N = 93) were randomized to one of two groups that determined the answer choices they saw in response to a question assessing their interest in multi-session cessation counseling. Group A choose between two sessions or a ""target"" of five sessions. Group B was given a third ""decoy"" option of seven sessions. Binary logistic regression was used to compare groups on the proportion of participants selecting the ""target.""
RESULTS


Among 90 participants with complete data, a decoy effect was not found. There was no significant difference between groups in the proportion of participants selecting the target of five sessions (47% in Group B vs. 53% in Group A; aOR = 0.76, 95%CI 0.48-1.19). Trial Registration This study was retrospectively registered at clinicaltrials.gov on December 13, 2019 (NCT04200157).",2020,"There was no significant difference between groups in the proportion of participants selecting the target of five sessions (47% in Group B vs. 53% in Group A; aOR = 0.76, 95%CI 0.48-1.19).","['adult tobacco users (N\u2009=\u200993', '90 participants with complete data']",[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3853727', 'cui_str': 'Tobacco user (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",[],[],90.0,0.0575242,"There was no significant difference between groups in the proportion of participants selecting the target of five sessions (47% in Group B vs. 53% in Group A; aOR = 0.76, 95%CI 0.48-1.19).","[{'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Rogers', 'Affiliation': 'Department of Population Health, New York University School of Medicine, 180 Madison Ave, New York, NY, 10016, USA. Erin.Rogers@nyulangone.org.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Vargas', 'Affiliation': 'Department of Population Health, New York University School of Medicine, 180 Madison Ave, New York, NY, 10016, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Voigt', 'Affiliation': 'Department of Population Health, New York University School of Medicine, 180 Madison Ave, New York, NY, 10016, USA.'}]",BMC research notes,['10.1186/s13104-019-4873-0']
547,31568796,Persistence of the clinical effect of grass allergen peptide immunotherapy after the second and third grass pollen seasons.,"BACKGROUND


Grass allergen peptides are in development for the treatment of grass pollen-induced allergic rhinoconjunctivitis. A previous randomized, placebo-controlled study demonstrated that grass allergen peptides significantly improved total rhinoconjunctivitis symptom scores (TRSSs) after posttreatment challenge (PTC) to rye grass in an environmental exposure unit after 1 intervening grass pollen season (GPS1).
OBJECTIVE


We sought to evaluate the efficacy/safety of 4 dosing regimens of grass allergen peptides after a second (GPS2) and third (GPS3) intervening GPS in the environmental exposure unit.
METHODS


Eligible subjects who were randomized in the parent study (GPS1) during the first year of recruitment were invited to participate in GPS2 and GPS3, which took place 1 and 2 years after treatment cessation, respectively. Participants were not treated further, and both participants and study personnel remained blinded. The primary efficacy end point was the change in mean TRSS (reported every 30 minutes) from GPS1 baseline to the follow-up PTC calculated across all time points over days 2 to 4 for GPS2 and across hours 1 to 3 over days 2 to 4 for GPS3. Secondary efficacy end points and safety were also assessed.
RESULTS


One hundred twenty-two and 85 participants were enrolled in GPS2 and GPS3, respectively. A numerically greater, but not statistically significant improvement from baseline in mean TRSS at PTC was observed in the group receiving one 6-nmol intradermal injection every 2 weeks for 14 weeks group compared with the placebo at GPS2 (-6.0 vs -3.6, P = .0535) and GPS3 (-6.2 vs -3.6, P = .1128). Similar findings were observed for the group receiving one 6-nmol intradermal injection every 2 weeks for 14 weeks at GPS3 (-6.4 vs -3.6, P = .0759). No adverse safety signals were detected.
CONCLUSION


Treatment with grass allergen peptides led to an improvement in allergic rhinoconjunctivitis symptoms after 3 intervening GPSs, corresponding to up to 2 years off treatment.",2020,"A previous randomized, placebo-controlled study demonstrated grass allergen peptides significantly improved total rhinoconjunctivitis symptom scores(TRSS) following post-treatment challenges(PTC) to rye grass in an Environmental Exposure Unit(EEU) after one intervening grass pollen season(GPS1).
","['Eligible individuals who were randomized in the parent study(GPS1) during the first year of recruitment were invited to participate in GPS2 and GPS3, which took place 1 and 2 years after treatment cessation respectively', '85 participants were enrolled in GPS2 and GPS3 respectively', 'grass pollen-induced allergic rhinoconjunctivitis(ARC']","['placebo', 'grass allergen peptide immunotherapy']","['total rhinoconjunctivitis symptom scores(TRSS', 'efficacy/safety', 'mean TRSS at PTC', 'adverse safety signals', 'ARC symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0440307', 'cui_str': 'Grass pollen (substance)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018210', 'cui_str': 'Grasses'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}]",85.0,0.334702,"A previous randomized, placebo-controlled study demonstrated grass allergen peptides significantly improved total rhinoconjunctivitis symptom scores(TRSS) following post-treatment challenges(PTC) to rye grass in an Environmental Exposure Unit(EEU) after one intervening grass pollen season(GPS1).
","[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Ellis', 'Affiliation': ""Departments of Medicine and Biomedical & Molecular Sciences, Queen's University, Kingston, Ontario, Canada; Allergy Research Unit, Kingston General Health Research Institute, Kingston, Ontario, Canada. Electronic address: ellisa@queensu.ca.""}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Frankish', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Armstrong', 'Affiliation': 'Adiga Life Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Steacy', 'Affiliation': 'Allergy Research Unit, Kingston General Health Research Institute, Kingston, Ontario, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Tenn', 'Affiliation': ""Departments of Medicine and Biomedical & Molecular Sciences, Queen's University, Kingston, Ontario, Canada; Allergy Research Unit, Kingston General Health Research Institute, Kingston, Ontario, Canada.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pawsey', 'Affiliation': 'Circassia, Oxford, United Kingdom.'}, {'ForeName': 'Roderick P', 'Initials': 'RP', 'LastName': 'Hafner', 'Affiliation': 'Circassia, Oxford, United Kingdom.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.09.010']
548,31906814,Functional Resistance Training Superiority Over Conventional Training in Metabolic Syndrome: A Randomized Clinical Trial.,"Metabolic syndrome (MetS) is a growing epidemic related with higher values of blood pressure (BP) and autonomic dysfunction. Scientific evidence has been indicating that functional resistance training (FRT) is superior over conventional (CRT) for muscle fatigue and pain, yet its effects on autonomic modulation (AM), BP and heart rate in MetS are unclear. We theorized that FRT can be superior to CRT in MetS patients because of larger muscle activation. This study compares FRT and CRT on AM, blood pressure, heart rate and muscle strength. Thirty-eight sex and age matched individuals (40 to 60 years) were randomized for FRT or CRT, with training intensity varying gradually from 30%-100% of one maximal repetition test (1MR), 3 times/week for 30 sessions. All outcomes were evaluated at baseline and post training. AM was assessed by heart rate variability (mean RR, RMSSD, SDNN, LF, HF, TINN, RRtri, SD1 and SD2). BP (mmHg) was obtained by cuff measures. Muscle strength was assessed by 1MR. An increase in cardiac parasympathetic activity was observed in individuals allocated to FRT in comparison to CRT group (RMSSD ∆40%; SD1 ∆39%; and HF  ms   2  ∆80%). Moreover, just FRT was capable of reducing BP post intervention (SBP from 129.21 ± 19.02 to 118.94 ± 14.14 mmHg,  p  < .009,/d/ = 0.49; DBP from 85.26 ± 11.48 to 77.76 ± 8.93 mmHg,  p  < .01,/d/ = 0.51). Both groups had a similar increase in muscle strength and no changes between HR. Progressive FRT was more beneficial to CRT regarding AM, increasing vagal activity, and reducing blood pressure in MetS individuals.",2020,An increase in cardiac parasympathetic activity was observed in individuals allocated to FRT in comparison to CRT group (RMSSD ∆40%; SD1 ∆39%; and HF  ms 2  ∆80%).,"['Metabolic Syndrome', 'Thirty-eight sex and age matched individuals (40 to 60\xa0years']","['FRT or CRT', 'FRT', 'functional resistance training (FRT) is superior over conventional (CRT', 'Functional Resistance Training Superiority over Conventional Training']","['AM, blood pressure, heart rate and muscle strength', 'cardiac parasympathetic activity', 'Muscle strength', 'muscle strength', 'vagal activity', 'blood pressure (BP) and autonomic dysfunction', 'autonomic modulation (AM), BP and heart rate', 'blood pressure', 'BP (mmHg', 'heart rate variability (mean RR, RMSSD, SDNN, LF, HF, TINN, RRtri, SD1 and SD2']","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1861380', 'cui_str': 'Syndactyly, Type I'}]",38.0,0.0184077,An increase in cardiac parasympathetic activity was observed in individuals allocated to FRT in comparison to CRT group (RMSSD ∆40%; SD1 ∆39%; and HF  ms 2  ∆80%).,"[{'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Turri-Silva', 'Affiliation': 'University of Brasilia.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Ricci-Vitor', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Cipriano', 'Affiliation': 'University of Brasilia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garner', 'Affiliation': 'Oxford Brookes University.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Netto', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Thaís', 'Initials': 'T', 'LastName': 'Giacon', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Diego Giulliano', 'Initials': 'DG', 'LastName': 'Destro Christofaro', 'Affiliation': 'São Paulo State University (UNESP).'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'Marques Vanderlei', 'Affiliation': 'Oxford Brookes University.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1679333']
549,31906881,Impacts of antenatal nursing interventions on mothers' breastfeeding self-efficacy: an experimental study.,"BACKGROUND


A considerable amount of research demonstrates how breastfeeding self-efficacy significantly influences breastfeeding outcomes. The aim of this study was to evaluate the role of nursing intervention on mother's breastfeeding self-efficacy.
METHODS


In this experimental investigation, 130 pregnant women who attended a primary health care centre were randomly assigned to the experimental (n = 65) or control (n = 65) groups. The experimental group received two 60-90 min group breastfeeding educational sessions based on the breastfeeding self-efficacy theory along with routine care. Mothers' knowledge, attitudes, prenatal and postnatal self-efficacy towards the breastfeeding were compared between both groups. The Iowa Infant Feeding Attitude Scale measured the attitudes. Prenatal Breastfeeding Self-Efficacy Scale measured the self-efficacy during pregnancy and Breastfeeding Self-Efficacy-Short Form measured the self-efficacy in postnatal period.
RESULTS


Breastfeeding self-efficacy during pregnancy and following two months of delivery in the experimental group was significantly higher. The experimental group had a higher level of knowledge and attitude in comparison with subjects in the control group. In addition, the mothers who breastfed exclusively had higher levels of postnatal self-efficacy in both experimental and control groups compared to formula feeding women (52.00 vs. 39.45 in the control and 57.69 vs. 36.00 in the experimental subjects; P < 0.001).
CONCLUSION


The present investigation suggests that antenatal breastfeeding education is an effective way to increase the level of breastfeeding self-efficacy, which increases exclusive breastfeeding practice.",2020,"In addition, the mothers who breastfed exclusively had higher levels of postnatal self-efficacy in both experimental and control groups compared to formula feeding women (52.00 vs. 39.45 in the control and 57.69 vs. 36.00 in the experimental subjects; P < 0.001).
","['130 pregnant women who attended a primary health care centre', 'mothers']","['antenatal nursing interventions', 'nursing intervention', '60-90\u2009min group breastfeeding educational sessions based on the breastfeeding self-efficacy theory along with routine care']","['Prenatal Breastfeeding Self-Efficacy Scale', 'levels of postnatal self-efficacy', 'breastfeeding self-efficacy', 'level of knowledge and attitude', ""Mothers' knowledge, attitudes, prenatal and postnatal self-efficacy"", 'Breastfeeding self-efficacy']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0222045'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",130.0,0.0201954,"In addition, the mothers who breastfed exclusively had higher levels of postnatal self-efficacy in both experimental and control groups compared to formula feeding women (52.00 vs. 39.45 in the control and 57.69 vs. 36.00 in the experimental subjects; P < 0.001).
","[{'ForeName': 'Safiya Sabri', 'Initials': 'SS', 'LastName': 'Piro', 'Affiliation': 'College of Nursing, University of Duhok, Duhok, Kurdistan Region, Iraq. ssp.khozi@gmail.com.'}, {'ForeName': 'Hamdia Mirkhan', 'Initials': 'HM', 'LastName': 'Ahmed', 'Affiliation': 'College of Nursing, Hawler Medical University, Erbil, Kurdistan Region, Iraq.'}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2701-0']
550,31893730,Individual predictors of response to biofeedback training for second-language production.,"While recent research suggests that visual biofeedback can facilitate speech production training in clinical populations and second language (L2) learners, individual learners' responsiveness to biofeedback is highly variable. This study investigated the hypothesis that the type of biofeedback provided, visual-acoustic versus ultrasound, could interact with individuals' acuity in auditory and somatosensory domains. Specifically, it was hypothesized that learners with lower acuity in a sensory domain would show greater learning in response to biofeedback targeting that domain. Production variability and phonological awareness were also investigated as predictors. Sixty female native speakers of English received 30 min of training, randomly assigned to feature visual-acoustic or ultrasound biofeedback, for each of two Mandarin vowels. On average, participants showed a moderate magnitude of improvement (decrease in Euclidean distance from a native-speaker target) across both vowels and biofeedback conditions. The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research. Specifically, high phonological awareness and low production variability post-training were associated with better outcomes, although these effects were mediated by vowel target. This line of research could have implications for personalized learning in both L2 pedagogy and clinical practice.",2019,"The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research.","[""individuals' acuity in auditory and somatosensory domains"", 'Sixty female native speakers of English received']","['visual biofeedback', '30\u2009min of training, randomly assigned to feature visual-acoustic or ultrasound biofeedback', 'visual-acoustic versus ultrasound', 'biofeedback training']","['Euclidean distance', 'Production variability and phonological awareness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",60.0,0.0456901,"The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research.","[{'ForeName': 'Joanne Jingwen', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Ayala', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Harel', 'Affiliation': 'Department of Applied Statistics, Social Science, and Humanities, New York University, 246 Greene Street, 3rd Floor, New York, New York 10003, USA.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Shiller', 'Affiliation': ""École d'orthophonie et d'audiologie, Université de Montréal, Case Postale 6128, Succursale Centre-ville, Montréal, Québec, H3C 3J7, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McAllister', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}]",The Journal of the Acoustical Society of America,['10.1121/1.5139423']
551,31888712,"Internet-based interpersonal psychotherapy for stress, anxiety, and depression in prenatal women: study protocol for a pilot randomized controlled trial.","BACKGROUND


Psychological distress, defined as depression, anxiety and perceived stress, during pregnancy is common, with 15-25% of women experiencing clinically significant levels of such distress. Despite the far-reaching impact of prenatal psychological distress on mothers and their children, and that women are receptive to screening, few providers routinely screen for prenatal psychological distress and less than one in five women will receive the mental health care that they require. There is a lack of certainty regarding the most effective treatments for prenatal psychological distress. No online interpersonal psychotherapy (IPT) trials have been conducted that focus on improving psychological distress in prenatal women. The purpose of this pilot randomized controlled trial is to evaluate the perspectives of pregnant women on the feasibility and acceptability of online IPT (e-IPT) delivered during pregnancy.
METHODS


A pilot randomized controlled trial design with repeated measures will evaluate the feasibility and acceptability of e-IPT for pregnant women compared to routine prenatal care. Qualitative interviews with 15-30 individuals in the intervention group will provide further data on the feasibility and acceptability of the intervention. Assessment of feasibility will include the ease of accessing and completing the intervention. Women will also be asked about what barriers there were to starting and completing the e-IPT. Assessment of acceptability will inquire about the perception of women regarding the intervention and its various features. A sample size of 160 consenting pregnant women aged 18 years and older will be enrolled and randomized into the experimental (e-IPT) or control (routine care) condition. The secondary outcome measures include: depression, anxiety and stress symptoms; self-efficacy; self-mastery; self-esteem; relationship quality (spouse, immediate family members); coping; and resilience. All participants will complete the aforementioned measures at baseline during pregnancy (T 1 ), 3 months postrandomization (T 2 ), at 8 months of pregnancy (T 3 ), and 3 months postpartum (T 4 ).
DISCUSSION


The results of this pilot randomized controlled trial will provide data on the feasibility and acceptability of the intervention and identify necessary adaptations. This study will allow for optimization of full trial processes and inform the evaluation strategy, including sample size calculations for the full randomized controlled trial.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01901796. Registered on 18 December 2014.",2019,Qualitative interviews with 15-30 individuals in the intervention group will provide further data on the feasibility and acceptability of the intervention.,"['pregnant women', 'pregnant women compared to routine prenatal care', 'prenatal women', '160 consenting pregnant women aged 18 years and older will be enrolled and randomized into the experimental (e-IPT) or control (routine care) condition']","['online interpersonal psychotherapy (IPT', 'online IPT (e-IPT', 'e-IPT', 'Internet-based interpersonal psychotherapy']","[' depression, anxiety and stress symptoms; self-efficacy; self-mastery; self-esteem; relationship quality (spouse, immediate family members); coping; and resilience', 'psychological distress', 'feasibility and acceptability']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C1273520', 'cui_str': 'Immediate family member'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",30.0,0.166398,Qualitative interviews with 15-30 individuals in the intervention group will provide further data on the feasibility and acceptability of the intervention.,"[{'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Bright', 'Affiliation': 'Faculty of Nursing, University of Calgary, 2500 University Dr. N.W, Calgary, AB, T2N 1N4, Canada. ksbright@ucalgary.ca.'}, {'ForeName': 'Muhammad Kashif', 'Initials': 'MK', 'LastName': 'Mughal', 'Affiliation': 'Faculty of Nursing, University of Calgary, 2500 University Dr. N.W, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Wajid', 'Affiliation': 'Faculty of Nursing, University of Calgary, 2500 University Dr. N.W, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lane-Smith', 'Affiliation': 'Faculty of Nursing, University of Calgary, 2500 University Dr. N.W, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Faculty of Nursing, University of Calgary, 2500 University Dr. N.W, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Roy', 'Affiliation': 'Faculty of Nursing, University of Calgary, 2500 University Dr. N.W, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Sander Veldhuyzen', 'Initials': 'SV', 'LastName': 'Van Zanten', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton, AB, T6G 2R7, Canada.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Mcneil', 'Affiliation': 'Faculty of Nursing, University of Calgary, 2500 University Dr. N.W, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Stuart', 'Affiliation': 'Faculty of Nursing, University of Calgary, 2500 University Dr. N.W, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Kingston', 'Affiliation': 'Faculty of Nursing, University of Calgary, 2500 University Dr. N.W, Calgary, AB, T2N 1N4, Canada.'}]",Trials,['10.1186/s13063-019-3897-z']
552,31888728,"Evaluating the therapeutic efficacy of the Chinese herbal medicine Yishen Tongbi decoction in patients with active rheumatoid arthritis: protocol for a randomized, controlled, noninferiority trial.","BACKGROUND


Rheumatoid arthritis (RA) is a common chronic autoimmune disease that seriously affects the quality of life of patients because of damage to joints. Presently, RA is mainly treated with disease-modifying antirheumatic drugs (DMARDs) or biological agents; however, they offer limited efficacy in some patients. Therefore, additional therapeutic strategies need to be developed. Yishen Tongbi decoction is a traditional Chinese medicine formulation widely used to treat RA in China. However, currently, there is insufficient evidence to recommend its use for the treatment of RA. Therefore, we aim to verify the efficacy of Yishen Tongbi decoction to treat RA by a noninferiority trial, and to provide a basis for its use with a full-scale clinical trial.
METHODS/DESIGN


One hundred eligible patients with RA will be randomized into two groups of 50 patients. One group will receive Yishen Tongbi decoction and placebo replacing methotrexate (MTX), while the other group will receive MTX and placebo replacing Yishen Tongbi decoction. Patient's whose visual analogue scale score for pain is greater than 40 mm will be administered nonsteroidal anti-inflammatory drugs (such as enteric-coated diclofenac sodium, 25 mg three times a day); administration of all medications will be recorded. The clinical indicators of patients and their disease activity will be assessed at baseline and at 4, 12 and 24 weeks after treatment initiation. The primary outcome of efficacy will be the proportion of patients who demonstrate a favourable response based on their Clinical Disease Activity Index score at 24 weeks after treatment. All adverse events will be reported.
DISCUSSION


Traditional Chinese medicine theory and modern western medicine research have identified the efficacy of Yishen Tongbi decoction to treat RA. Previous clinical observation and efficacy trials of Yishen Tongbi decoction in animal models for the treatment of RA has demonstrated significant effect. Because of the potential benefits of Yishen Tongbi decoction in the treatment of patients with RA, we designed this double-blind, prospective, randomized controlled trial; the results and conclusions of the trail will be published after the completion of the study.
TRIAL REGISTRATION


Chinese Clinical Trials Registry, ChiCTR1900024902. Registered on 3 August 2019.",2019,Previous clinical observation and efficacy trials of Yishen Tongbi decoction in animal models for the treatment of RA has demonstrated significant effect.,"['One hundred eligible patients with RA will be randomized into two groups of 50 patients', 'patients with active rheumatoid arthritis', 'patients with RA']","['Yishen Tongbi decoction and placebo replacing methotrexate (MTX', 'diclofenac sodium', 'MTX and placebo replacing Yishen Tongbi decoction', 'Yishen Tongbi decoction', 'Chinese herbal medicine Yishen Tongbi decoction']","['Clinical Disease Activity Index score', 'visual analogue scale score for pain']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C2003492', 'cui_str': 'yishen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",100.0,0.317424,Previous clinical observation and efficacy trials of Yishen Tongbi decoction in animal models for the treatment of RA has demonstrated significant effect.,"[{'ForeName': 'Lianyu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'The First Clinical Medical College of Guangzhou University of Chinese Medicine, 12 Airport Road, Baiyun District, Guangzhou, China.'}, {'ForeName': 'Meilin', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'The First Clinical Medical College of Guangzhou University of Chinese Medicine, 12 Airport Road, Baiyun District, Guangzhou, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'The First Clinical Medical College of Guangzhou University of Chinese Medicine, 12 Airport Road, Baiyun District, Guangzhou, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, 16 Airport Road, Baiyun District, Guangzhou, China.'}, {'ForeName': 'Mingying', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, 16 Airport Road, Baiyun District, Guangzhou, China.'}, {'ForeName': 'Guangxing', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, 16 Airport Road, Baiyun District, Guangzhou, China. cgx02@hotmail.com.'}]",Trials,['10.1186/s13063-019-4005-0']
553,31888751,Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS: a randomized controlled trial protocol.,"BACKGROUND


It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven.
METHODS/DESIGN


This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to < 50% or < 5 cm in size), along with clinical improvement. Secondary endpoints: long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences.
DISCUSSION


The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home.",2019,"The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON.
",['One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain'],"['plastic vs. self-expanding metal stents', 'LAMS', 'LAMS or plastic-stent group', 'endoscopic ultrasound-guided drainage', 'lumen-apposing metal stents (LAMS']","['long-term (4\u2009months) clinical success (total resolution or 5\u2009cm), procedure duration, level of difficulty, safety, and recurrences', 'short-term (4\u2009weeks) clinical success']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376443', 'cui_str': 'Ultrasonography, Endoscopic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0522497', 'cui_str': 'Transmural (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0441290', 'cui_str': 'Metal stent (physical object)'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376443', 'cui_str': 'Ultrasonography, Endoscopic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",114.0,0.185576,"The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON.
","[{'ForeName': 'Joan B', 'Initials': 'JB', 'LastName': 'Gornals', 'Affiliation': ""Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Feixa Llarga s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain. jgornals@bellvitgehospital.cat.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Perez-Miranda', 'Affiliation': 'Endoscopy Unit, Hospital Universitario Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Vazquez-Sequeiros', 'Affiliation': 'Endoscopy Unit, Gastroenterology and Hepatology Service, Hospital Ramon y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Vila', 'Affiliation': 'Endoscopy Unit, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Esteban', 'Affiliation': 'Endoscopy Unit, Department of Digestive Diseases, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Gonzalez-Huix', 'Affiliation': 'Endoscopy Unit, Hospital Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Guarner-Argente', 'Affiliation': 'Endoscopy Unit, Hospital Sant Pau i Santa Creu, Barcelona, Spain.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Sanchez-Yague', 'Affiliation': 'Endoscopy Unit, Hospital Costa del Sol, Marbella, Spain.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Teran', 'Affiliation': 'Department of Digestive Diseases, Hospital Universitario Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Bas-Cutrina', 'Affiliation': ""Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Feixa Llarga s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'De La Serna', 'Affiliation': 'Endoscopy Unit, Hospital Universitario Rio Hortega, Valladolid, Spain.'}, {'ForeName': 'Ana Garcia', 'Initials': 'AG', 'LastName': 'De Paredes', 'Affiliation': 'Endoscopy Unit, Gastroenterology and Hepatology Service, Hospital Ramon y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Ballester', 'Affiliation': 'Endoscopy Unit, Hospital Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Velasquez-Rodriguez', 'Affiliation': ""Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Feixa Llarga s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Salord', 'Affiliation': 'Hepato-Bilio-Pancreatic Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Tebe', 'Affiliation': ""Biostatistics Unit, Institute of Biomedical Research of Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Hereu', 'Affiliation': 'Clinical Research and Clinical Trial Unit (UICEC IDIBELL), Plataforma SCRen, Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Sebas', 'Initials': 'S', 'LastName': 'Videla', 'Affiliation': 'Clinical Research and Clinical Trial Unit (UICEC IDIBELL), Plataforma SCRen, Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Barcelona, Catalonia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3988-x']
554,31888752,Monitoring adverse social and medical events in public health trials: assessing predictors and interpretation against a proposed model of adverse event reporting.,"BACKGROUND


Although adverse event (AE) monitoring in trials focusses on medical events, social outcomes may be important in public or social care trials. We describe our approach to reporting and categorising medical and other AE reports, using a case study trial. We explore predictors of medical and social AEs, and develop a model for conceptualising safety monitoring.
METHODS


The Building Blocks randomised controlled trial of specialist home visiting recruited 1618 first-time mothers aged 19 years or under at 18 English sites. Event reports collected during follow-up were independently reviewed and categorised as either Medical (standard Good Clinical Practice definition), or Social (trial-specific definition). A retrospectively developed system was created to classify AEs. Univariate analyses explored the association between baseline participant and study characteristics and the subsequent reporting of events. Factors significantly associated at this stage were progressed to binary logistic regressions to assess independent predictors.
RESULTS


A classification system was derived for reported AEs that distinguished between Medical or Social AEs. One thousand, three hundred and fifteen event reports were obtained for mothers or their babies (1033 Medical, 257 Social). Allocation to the trial intervention arm was associated with increased likelihood of Medical rather than Social AE reporting. Poorer baseline psycho-social status predicted both Medical and Social events, and poorer psycho-social status better predicted Social rather than Medical events. Baseline predictors of Social AEs included being younger at recruitment (OR = 0.78 (CI = 0.67 to 0.90), p = 0.001), receiving benefits (OR = 1.60 (CI = 1.09 to 2.35), p = 0.016), and having a higher antisocial behaviour score (OR = 1.22 (CI = 1.09 to 1.36), p < 0.001). Baseline predictors of Medical AEs included having a limiting long-term illness (OR = 1.37 (CI = 1.01 to 1.88), p = 0.046), poorer mental health (OR = 1.03 (CI = 1.01 to 1.05), p = 0.004), and being in the intervention arm of the trial (OR = 1.34 (CI = 1.07 to 1.70), p = 0.012).
CONCLUSIONS


Continuity between baseline and subsequent adverse experiences was expected despite potentially beneficial intervention impact. We hypothesise that excess events reported for intervention-arm participants is likely attributable to surveillance bias. We interpreted our findings against a new model that explicates processes that may drive event occurrence, presentation and reporting. Focussing only upon Medical events may miss the well-being and social circumstances that are important for interpreting intervention safety and participant management.
TRIAL REGISTRATION


ISRCTN, ID: ISRCTN23019866. Registered on 20 April 2009.",2019,"Poorer baseline psycho-social status predicted both Medical and Social events, and poorer psycho-social status better predicted Social rather than Medical events.","['specialist home visiting recruited 1618 first-time mothers aged 19 years or under at 18 English sites', 'One thousand, three hundred and fifteen event reports were obtained for mothers or their babies (1033 Medical, 257 Social']",['ID'],"['antisocial behaviour score', 'Poorer baseline psycho-social status predicted both Medical and Social events, and poorer psycho-social status better predicted Social rather than Medical events', 'poorer mental health']","[{'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]",[],"[{'cui': 'C0233523', 'cui_str': 'Antisocial behavior (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0699806', 'cui_str': 'Social status'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",257.0,0.0687475,"Poorer baseline psycho-social status predicted both Medical and Social events, and poorer psycho-social status better predicted Social rather than Medical events.","[{'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Moody', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, UK. MoodyG@cardiff.ac.uk.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Addison', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Heath Park, Cardiff, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Wallace', 'Affiliation': 'PRIME (Wales Centre for Primary and Emergency Care Research), Heath Park, Cardiff, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, UK.'}]",Trials,['10.1186/s13063-019-3961-8']
555,31783267,Mobile community learning programme's effectiveness in case management for psychiatric nurses: A preliminary randomised controlled trial.,"BACKGROUND


The global health care system has applied case management (CM) as a care delivery service provided by nurses. Nurses require continuing education in CM to enhance their professional knowledge and competence. Mobile communities have been used to promote continuing education for medical professionals. However, limited studies have examined the effectiveness of such learning programmes in CM for psychiatric nurses.
OBJECTIVE


To evaluate the effectiveness of a mobile community learning (MCL) programme in CM for psychiatric nurses.
DESIGN


This study used an experimental two-group pre- and post-test design.
SETTINGS AND PARTICIPANTS


Psychiatric nurses employed in a psychiatric teaching hospital situated in northern Taiwan were recruited.
METHODS


Nurses were randomly allocated to the experimental or comparison group. The former participated in the learning intervention in CM. The CM knowledge index and a competence scale were used to determine outcomes. Pre-tests and 2-month post-tests were conducted. The MCL programme comprised five simulated learning modules, self-assessment questions, learning cases, learning resources and experience sharing. A two-way repeated-measures analysis of variance was performed to evaluate the effect of the intervention on target outcomes.
RESULTS


The questionnaires were completed by 48 participants. The two groups possessed high homogeneity with regard to characteristics and pre-test outcomes. Differences between the two groups regarding CM knowledge (F = 22.99, p < .01) and competence (F = 6.33, p = .015) were significant. The programme had a positive benefit on the learning experience in the experimental group; the mean satisfaction score for the programme reached 4.27 (range, 1-5).
CONCLUSIONS


MCL programmes for psychiatric nurses can effectively enhance CM knowledge and competence. However, these methods cannot completely replace the continuing education approach for achieving CM competence.",2020,"The programme had a positive benefit on the learning experience in the experimental group; the mean satisfaction score for the programme reached 4.27 (range, 1-5).
","['psychiatric nurses', 'Nurses', 'Psychiatric nurses employed in a psychiatric teaching hospital situated in northern Taiwan were recruited']","['Mobile community learning programme', 'mobile community learning (MCL) programme', 'learning intervention']","['CM knowledge index and a competence scale', 'CM knowledge', 'mean satisfaction score']","[{'cui': 'C1964024', 'cui_str': 'Mental health nurse (occupation)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",48.0,0.0549042,"The programme had a positive benefit on the learning experience in the experimental group; the mean satisfaction score for the programme reached 4.27 (range, 1-5).
","[{'ForeName': 'Wen-I', 'Initials': 'WI', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Sciences, 365, Ming Te Road., Beitou District, 11219 Taipei City, Taiwan, R.O.C. Electronic address: wenyi@ntunhs.edu.tw.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, Tri-Service General Hospital Beitou Branch, No. 60, Xinmin Road, Beitou District, 11243 Taipei City, Taiwan, R.O.C.'}, {'ForeName': 'Chang-Yen', 'Initials': 'CY', 'LastName': 'Liao', 'Affiliation': 'College of Nursing, National Taipei University of Nursing and Health Sciences, 365, Ming Te Road., Beitou District, 11219 Taipei City, Taiwan, R.O.C.'}, {'ForeName': 'Pei-Ru', 'Initials': 'PR', 'LastName': 'Chao', 'Affiliation': 'Department of Nursing, Tri-Service General Hospital Beitou Branch, Road., Beitou District, 11219 Taipei City, Taiwan, R.O.C.'}, {'ForeName': 'Kuo-Chung', 'Initials': 'KC', 'LastName': 'Chu', 'Affiliation': 'Department of Information Management, National Taipei University of Nursing and Health Sciences, 365, Ming Te Road., Beitou District, 11219 Taipei City, Taiwan, R.O.C.'}]",Nurse education today,['10.1016/j.nedt.2019.104259']
556,31898526,"Associations between intestinal parasitic infections, anaemia, and diarrhoea among school aged children, and the impact of hand-washing and nail clipping.","OBJECTIVE


In marginalized setting, under-nutrition and illnesses due to infectious agents create a vicious circle. In our previous study, we reported that easy-to-do hand hygiene interventions were effective in preventing intestinal parasite infections (IPIs) and reduce the rate of anaemia among school-aged children. The aim of this study was to assess the pattern of associations between IPIs, anaemia and diarrhoea among the school-aged children and to explore if the observed impact of hand-washing and nail clipping interventions in our findings was similar across children with different baseline demographic and disease characteristics. The study was based on the analysis of data that was collected during the randomized controlled trial and hence have used the same study participants and study area.
RESULTS


Children with IPIs had a much higher chance of also being anaemic (AOR 2.09, 95% CI 1.15-3.80), having diarrhoea (AOR 2.83, 95% CI 1.57-5.09), and vice versa. Anaemia and diarrhoea were very strongly related (AOR 9.62, 95% CI 5.18-17.85). Overall, hand-washing with soap at key times and weekly nail clipping were efficacious in preventing intestinal parasite re-infection among children despite the differences in baseline demographic characteristics.
TRIAL REGISTRATION


NCT01619254 (June 09/2012).",2020,"Anaemia and diarrhoea were very strongly related (AOR 9.62, 95% CI 5.18-17.85).","['school aged children', 'children with different baseline demographic and disease characteristics', 'school-aged children']",['nail clipping'],"['intestinal parasitic infections, anaemia, and diarrhoea', 'rate of anaemia', 'Anaemia and diarrhoea', 'having diarrhoea', 'IPIs, anaemia and diarrhoea']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0030499', 'cui_str': 'Parasitic Infections'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.107537,"Anaemia and diarrhoea were very strongly related (AOR 9.62, 95% CI 5.18-17.85).","[{'ForeName': 'Mahmud Abdulkader', 'Initials': 'MA', 'LastName': 'Mahmud', 'Affiliation': 'Medical Microbiology and Immunology Department, Biomedical Division, School of Medicine, Mekelle University, PO. Box: 1871, Mekelle, Ethiopia. muheab2008@yahoo.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Spigt', 'Affiliation': 'Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Afework Mulugeta', 'Initials': 'AM', 'LastName': 'Bezabih', 'Affiliation': 'School of Public Health, College of Health Sciences, Mekelle University, Mekelle, Ethiopia.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Dinant', 'Affiliation': 'Department of Family Medicine, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Roman Blanco', 'Initials': 'RB', 'LastName': 'Velasco', 'Affiliation': 'Department of Surgery, School of Medicine, Alcala University, Madrid, Spain.'}]",BMC research notes,['10.1186/s13104-019-4871-2']
557,31888699,"Transcranial direct current stimulation in management of pain, mood, functionality, and quality of life in patients undergoing hemodialysis: a study protocol for a double-blind controlled randomized trial.","BACKGROUND


Persistent pain can lead to incapacitation requiring long-term pharmacological treatment. Up to 82% of chronic kidney disease (CKD) patients undergoing hemodialysis (HD) have chronic pain and most do not respond to usual medication. Advances in non-pharmacological treatments are necessary to promote pain relief without side effects and to restore functionality. Transcranial direct current stimulation (tDCS) promises to be a novel, cost-efficient, non-pharmacological treatment for CKD patients with chronic pain. In this study, we hypothesize that tDCS could improve pain, depression, functionality, and quality of life in patients with CKD undergoing HD.
METHODS/DESIGN


We describe a single-center, parallel-design, double blind randomized, sham-controlled trial. Forty-five subjects with CKD undergoing HD will be randomized to a motor cortex (M1), a dorso lateral prefrontal cortex (DLPFC), or a sham group. A total of ten sessions will be administered to participants over 4 weeks using a monophasic continuous current with an intensity of 2 mA for 20 min. Participants will be evaluated at baseline, immediately after the tenth session, and at 1 week and 4 weeks of follow-up after the intervention. Pain, depression, functionality, and quality of life will be evaluated.
DISCUSSION


The results from this study will provide initial clinical evidence on the efficacy and safety of tDCS in patients with CKD undergoing HD.
TRIAL REGISTRATION


Brazilian Clinical Trials Registry/Registro Brasileiro de Ensaios Clínicos (ensaiosclinicos.gov.br), 1111-1216-0137. Registered on 20 June 2018.",2019,"In this study, we hypothesize that tDCS could improve pain, depression, functionality, and quality of life in patients with CKD undergoing HD.
","['patients with CKD undergoing HD', 'Forty-five subjects with CKD undergoing HD', 'patients undergoing hemodialysis', 'CKD patients with chronic pain', 'chronic kidney disease (CKD) patients undergoing hemodialysis (HD']","['Transcranial direct current stimulation', 'Transcranial direct current stimulation (tDCS', 'motor cortex (M1), a dorso lateral prefrontal cortex (DLPFC', 'tDCS']","['pain, mood, functionality, and quality of life', 'Pain, depression, functionality, and quality of life', 'pain, depression, functionality, and quality of life', 'efficacy and safety of tDCS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]",45.0,0.273252,"In this study, we hypothesize that tDCS could improve pain, depression, functionality, and quality of life in patients with CKD undergoing HD.
","[{'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Quintiliano', 'Affiliation': 'Department of Medicine, Federal University of Rio Grande do Norte, Rio Grande do Norte, 620 Nilo Peçanha St., Natal, RN, 59012-300, Brazil. artur_bezerra@hotmail.com.'}, {'ForeName': 'Tayanne', 'Initials': 'T', 'LastName': 'Oehmen', 'Affiliation': 'Instituto do Rim, Natal, Brazil.'}, {'ForeName': 'Gianna Mastroianni', 'Initials': 'GM', 'LastName': 'Kirsztajn', 'Affiliation': 'Department of Medicine (Nephrology), Federal University of Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Pegado', 'Affiliation': 'Graduate Program in Rehabilitation Science, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}]",Trials,['10.1186/s13063-019-3769-6']
558,31888708,Combining physical therapy and cognitive behavioral therapy techniques to improve balance confidence and community participation in people with unilateral transtibial amputation who use lower limb prostheses: a study protocol for a randomized sham-control clinical trial.,"BACKGROUND


Low balance confidence is a prevalent yet overlooked issue among people who use lower limb prostheses (LLP) that can diminish community integration and quality of life. There is a critical need to develop rehabilitation programs that specifically target balance confidence in people who use LLP. Previous research has shown that multicomponent interventions including cognitive-behavioral therapy (CBT) techniques and exercise are feasible and effective for improving balance confidence in older adults. Therefore, a cognitive behavioral-physical therapy (CBPT) intervention was developed to target balance confidence and increase community integration in people who use LLP.
METHODS/DESIGN


This randomized control trial will recruit 60 people who use LLP with low balance confidence. Participants will be randomized to the CBPT intervention condition or control condition.
DISCUSSION


The trial is designed to test the effects of the CBPT intervention on balance confidence and functional mobility in lower limb prosthesis users by examining self-reported and objective measures of community integration and quality of life. The trial will also examine the relationship between changes in balance confidence and changes in community integration following participation in CBPT intervention. Additionally, through participant feedback, researchers will identify opportunities to improve intervention efficacy.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03411148. Registration date: January 26, 2018.",2019,The trial will also examine the relationship between changes in balance confidence and changes in community integration following participation in CBPT intervention.,"['older adults', 'people with unilateral transtibial amputation who use lower limb prostheses', 'lower limb prosthesis users', '60 people who use LLP with low balance confidence', 'people who use LLP', 'people who use lower limb prostheses (LLP']","['cognitive behavioral-physical therapy (CBPT) intervention', 'CBPT intervention condition or control condition', 'physical therapy and cognitive behavioral therapy techniques', 'CBPT intervention']","['balance confidence and functional mobility', 'balance confidence and community participation', 'community integration and quality of life']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C1096093', 'cui_str': 'Prosthesis user'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0009476', 'cui_str': 'Community Participation'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0034380'}]",,0.083597,The trial will also examine the relationship between changes in balance confidence and changes in community integration following participation in CBPT intervention.,"[{'ForeName': 'McKenzie O', 'Initials': 'MO', 'LastName': 'Bourque', 'Affiliation': 'Department of Psychology, Rosalind Franklin University of Medicine and Science, 3333 Green Bay Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Schneider', 'Affiliation': 'Department of Psychology, Rosalind Franklin University of Medicine and Science, 3333 Green Bay Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Calamari', 'Affiliation': 'Department of Psychology, Rosalind Franklin University of Medicine and Science, 3333 Green Bay Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Reddin', 'Affiliation': 'Captain James A Lovell Federal Health Care Center, 2450 Buckley Rd, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Stachowiak', 'Affiliation': 'Captain James A Lovell Federal Health Care Center, 2450 Buckley Rd, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Major', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Northwestern University, Prosthetics and Orthotics Center, 680 North Lake Shore Drive, Chicago, IL, 60611, USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Duncan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Northwestern University, Prosthetics and Orthotics Center, 680 North Lake Shore Drive, Chicago, IL, 60611, USA.'}, {'ForeName': 'Ranjini', 'Initials': 'R', 'LastName': 'Muthukrishnan', 'Affiliation': 'Edward Hines, Jr. VA Hospital, 5000 5th Ave, Hines, IL, 60141, USA.'}, {'ForeName': 'Noah J', 'Initials': 'NJ', 'LastName': 'Rosenblatt', 'Affiliation': ""Dr. William M. Scholl College of Podiatric Medicines' Center for Lower Extremity Ambulatory Research (CLEAR), Rosalind Franklin University of Medicine and Science, 3333 Green Bay Road, North Chicago, IL, 60064, USA. noah.rosenblatt@rosalindfranklin.edu.""}]",Trials,['10.1186/s13063-019-3929-8']
559,31888713,Efficacy of Bimin decoction for patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial.,"BACKGROUND


Allergic rhinitis (AR) is a common allergic disease. It affects people worldwide and traditional Chinese medicine is becoming popular among AR patients because it has a definite clinical effect and there are few adverse reactions. Lung qi deficiency and cold syndrome (LQDCS) is a frequent type of AR, and the Chinese herbal medicine bimin decoction (BMD) is prescribed for it. This study compared the clinical efficacy of BMD for AR patients with LQDCS to the conventional medicine loratadine and fluticasone nasal spray.
METHODS


The study was an open-label non-inferiority randomized controlled trial. A total of 108 AR patients with LQDCS aged 19 to 60 were randomly allocated in a 1:1 ratio to the BMD group or the control group by the central computer system in Beijing Hospital of Traditional Chinese Medicine from January 2017 to April 2018. In total, 98 participants completed the study (BMD group n = 51 and control group n = 47). Patients in the BMD group received BMD while those in the control group received fluticasone nasal spray and loratadine tablets for 4 weeks. The primary outcome was the change in the Total Nasal Symptom Score (TNSS) between the baseline and the end of treatment. Changes in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), nasal resistance, and acoustic rhinometry parameters were secondary outcomes. All side effects due to the treatments were recorded.
RESULTS


After the 4-week treatment, the total TNSS was significantly reduced in both groups compared to the baseline (P <  0.05). No significant between-groups differences were observed for changes in TNSS scores [- 0.298 (95% confidence interval -0.640 to 0.140)], which was within the defined non-inferiority margin. RQLQ in both groups decreased significantly (P <  0.001) from baseline, though a more obvious reduction was observed for the BMD group (P <  0.001). There were no significant differences in nasal resistance, nasal volume, or nasal minimum cross-sectional area between groups after treatment (P > 0.05).
CONCLUSIONS


These findings indicate that BMD helps relieve the symptoms of perennial AR and improves rhinitis-related quality of life. Our study indicates that BMD is non-inferior to loratadine tablets and fluticasone nasal spray for AR patients with LQDCS.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR-INR-16010063. Registered on 2 December 2016.",2019,"There were no significant differences in nasal resistance, nasal volume, or nasal minimum cross-sectional area between groups after treatment (P > 0.05).
","['AR patients with LQDCS to the conventional medicine', 'patients with perennial allergic rhinitis', '98 participants completed the study (BMD group n\u2009=\u200951 and control group n\u2009=\u200947', 'Allergic rhinitis (AR', 'Lung qi deficiency and cold syndrome (LQDCS', '108 AR patients with LQDCS aged 19 to 60', 'AR patients with LQDCS']","['loratadine', 'Bimin decoction', 'BMD', 'BMD group or the control group by the central computer system', 'fluticasone nasal spray', 'loratadine and fluticasone nasal spray', 'fluticasone nasal spray and loratadine tablets']","['symptoms of perennial AR and improves rhinitis-related quality of life', 'BMD', 'obvious reduction', 'nasal resistance, nasal volume, or nasal minimum cross-sectional area', 'RQLQ', 'TNSS scores', 'Total Nasal Symptom Score (TNSS', 'total TNSS', 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), nasal resistance, and acoustic rhinometry parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0035457', 'cui_str': 'Rhinitis, Allergic, Nonseasonal'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0065180', 'cui_str': 'Loratadine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009612', 'cui_str': 'Computer Systems'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance (observable entity)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0430619', 'cui_str': 'Rhinometry, Acoustic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",98.0,0.104658,"There were no significant differences in nasal resistance, nasal volume, or nasal minimum cross-sectional area between groups after treatment (P > 0.05).
","[{'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Otolaryngology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23 Back Street of Art Museum, Beijing, 100010, People's Republic of China.""}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ""Department of Otolaryngology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23 Back Street of Art Museum, Beijing, 100010, People's Republic of China.""}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Gai', 'Affiliation': ""Department of Otolaryngology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23 Back Street of Art Museum, Beijing, 100010, People's Republic of China.""}, {'ForeName': 'Jinshuai', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': ""Department of Otolaryngology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23 Back Street of Art Museum, Beijing, 100010, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Otolaryngology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23 Back Street of Art Museum, Beijing, 100010, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ""Department of Otolaryngology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23 Back Street of Art Museum, Beijing, 100010, People's Republic of China.""}, {'ForeName': 'Shaoting', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': ""Department of Otolaryngology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23 Back Street of Art Museum, Beijing, 100010, People's Republic of China.""}, {'ForeName': 'Junge', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Otolaryngology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, No. 23 Back Street of Art Museum, Beijing, 100010, People's Republic of China. wjgent@163.com.""}]",Trials,['10.1186/s13063-019-3763-z']
560,31888764,Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial.,"BACKGROUND


Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants.
METHODS/DESIGN


SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants.
DISCUSSION


Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates.
TRIAL REGISTRATION


ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.",2019,"DISCUSSION


Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants.","['preterm infants', 'preterm neonates', 'extremely preterm infants', '1600 infants']","['Cerebral near-infrared spectroscopy monitoring', 'cerebral NIRS oximetry']","['Severe brain injury', 'composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans', 'Cerebral hypoxia', 'risk of death or survival']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0376519', 'cui_str': 'Spectrometry, Near-Infrared'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0013526', 'cui_str': 'Echoencephalography'}, {'cui': 'C1527348', 'cui_str': 'Cerebral Hypoxia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1600.0,0.271079,"DISCUSSION


Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants.","[{'ForeName': 'Mathias Lühr', 'Initials': 'ML', 'LastName': 'Hansen', 'Affiliation': 'Department of Neonatology, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. mathias.luhr.hansen@gmail.com.'}, {'ForeName': 'Adelina', 'Initials': 'A', 'LastName': 'Pellicer', 'Affiliation': 'Department of Neonatology, La Paz University Hospital, Paseo De La Castellana 261, 28046, Madrid, Spain.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Dempsey', 'Affiliation': 'Infant Centre and Department of Paediatrics and Child Health, University College Cork, College Road, Cork, Ireland.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mintzer', 'Affiliation': 'Division of Newborn Medicine, Hackensack Meridian Health - Mountainside Medical Center, 1 Bay Ave, Montclair, NJ, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hyttel-Sørensen', 'Affiliation': 'Department of Intensive Care, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Heuchan', 'Affiliation': 'Department of Neonatology, Royal Hospital for Children, 1345 Govan Rd, Glasgow, G51 4TF, UK.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Hagmann', 'Affiliation': ""Department of Neonatology, Children's University Hospital of Zürich, Steinweisstrasse 75, 8037, Zurich, Switzerland.""}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Ergenekon', 'Affiliation': 'Department of Neonatology, Gazi University Hospital, Emniyet Mahallesi, Gazeteci Yazar Muammer Yaşar Bostancı Sokak, 06560, Yenimahalle/Ankara, Turkey.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Dimitriou', 'Affiliation': 'NICU, Department of Pediatrics, University General Hospital of Patras, 265 04, Patras, Greece.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Pichler', 'Affiliation': 'Department of Pediatrics, Medical University of Graz, Auenbruggerplatz 30, Graz, Austria.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Naulaers', 'Affiliation': 'Department of Neonatology, University Hospital Leuven, Herestraat 49, Leuven, Belgium.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Cheng', 'Affiliation': ""Department of Neonatology, Children's Hospital of Fudan University, 399 Wanyuan Rd, Minhang Qu, Shanghai Shi, China.""}, {'ForeName': 'Hercilia', 'Initials': 'H', 'LastName': 'Guimarães', 'Affiliation': 'Department of Neonatology, Centro hospitalar Universitário de São João, Alameda Prof. Hernâni Monteiro, 4200-319, Porto, Portugal.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Tkaczyk', 'Affiliation': 'Department of Neonatology, University Hospital Motol, V Uvalu 84, 150 06, Prague 5, Czech Republic.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Kreutzer', 'Affiliation': ""Department of Neonatology, University Children's Hospital Tuebingen, Hoppe-Seyler-Straße 1, 72076, Tuebingen, Germany.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Fumagalli', 'Affiliation': ""Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Via della Commenda 12, IT- 20122, Milan, Italy.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Claris', 'Affiliation': 'Department of Neonatology, Hospices Civil De Lyon, 3 Quai des Célestins, 69002, Lyon, France.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Lemmers', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, Lundlaan 6, 3584 EA, Utrecht, Netherlands.""}, {'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Fredly', 'Affiliation': 'Department of Neonatology, Oslo University Hospital, Kirkeveien, 166 0450, Oslo, Norway.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Szczapa', 'Affiliation': 'Department of Neonatology, Poznan University of Medical Sciences, Polna 33, 60-535, Poznań, Poland.'}, {'ForeName': 'Topun', 'Initials': 'T', 'LastName': 'Austin', 'Affiliation': 'Neonatal Intensive Care Unit, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0SW, UK.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'Copenhagen Trial Unit, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Gorm', 'Initials': 'G', 'LastName': 'Greisen', 'Affiliation': 'Department of Neonatology, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-019-3955-6']
561,31888745,Testing effectiveness of the revised Cape Town modified early warning and SBAR systems: a pilot pragmatic parallel group randomised controlled trial.,"BACKGROUND


Nurses' recognition of clinical deterioration is crucial for patient survival. Evidence for the effectiveness of modified early warning scores (MEWS) is derived from large observation studies in developed countries.
METHODS


We tested the effectiveness of the paper-based Cape Town (CT) MEWS vital signs observation chart and situation-background-assessment-recommendation (SBAR) communication guide. Outcomes were: proportion of appropriate responses to deterioration, differences in recording of clinical parameters and serious adverse events (SAEs) in intervention and control trial arms. Public teaching hospitals for adult patients in Cape Town were randomised to implementation of the CT MEWS/SBAR guide or usual care (observation chart without track-and-trigger information) for 31 days on general medical and surgical wards. Nurses in intervention wards received training, as they had no prior knowledge of early warning systems. Identification and reporting of patient deterioration in intervention and control wards were compared. In the intervention arm, 24 day-shift and 23 night-shift nurses received training. Clinical records were reviewed retrospectively at trial end. Only records of patients who had given signed consent were reviewed.
RESULTS


We recruited two of six CT general hospitals. We consented 363 patients and analysed 292 (80.4%) patient records (n = 150, 51.4% intervention, n = 142, 48.6% control arm). Assistance was summoned for fewer patients with abnormal vital signs in the intervention arm (2/45, 4.4% versus (vs) 11/81, 13.6%, OR 0.29 (0.06-1.39)), particularly low systolic blood pressure. There was a significant difference in recording between trial arms for parameters listed on the MEWS chart but omitted from the standard observations chart: oxygen saturation, level of consciousness, pallor/cyanosis, pain, sweating, wound oozing, pedal pulses, glucose concentration, haemoglobin concentration, and ""looks unwell"". SBAR was used twice. There was no statistically significant difference in SAEs (5/150, 3.3% vs 3/143, 2.1% P = 0.72, OR 1.61 (0.38-6.86)).
CONCLUSIONS


The revised CT MEWS observations chart improved recording of certain parameters, but did not improve nurses' ability to identify early signs of clinical deterioration and to summon assistance. Recruitment of only two hospitals and exclusion of patients too ill to consent limits generalisation of results. Further work is needed on educational preparation for the CT MEWS/SBAR and its impact on nurses' reporting behaviour.
TRIAL REGISTRATION


Pan African Clinical Trials Registry, PACTR201406000838118. Registered on 2 June 2014, www.pactr.org.",2019,"The revised CT MEWS observations chart improved recording of certain parameters, but did not improve nurses' ability to identify early signs of clinical deterioration and to summon assistance.","['patients who had given signed consent were reviewed', '363 patients and analysed 292 (80.4%) patient records (n\xa0=\u2009150, 51.4% intervention, n\xa0', 'Public teaching hospitals for adult patients in Cape Town']","['revised Cape Town modified early warning and SBAR systems', 'CT MEWS/SBAR guide or usual care (observation chart without track-and-trigger information', 'paper-based Cape Town (CT) MEWS vital signs observation chart and situation-background-assessment-recommendation (SBAR) communication guide']","['low systolic blood pressure', 'oxygen saturation, level of consciousness, pallor/cyanosis, pain, sweating, wound oozing, pedal pulses, glucose concentration, haemoglobin concentration, and ""looks unwell', 'proportion of appropriate responses to deterioration, differences in recording of clinical parameters and serious adverse events (SAEs', 'SAEs', 'abnormal vital signs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}]","[{'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0518766'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0234425', 'cui_str': 'Level of consciousness (observable entity)'}, {'cui': 'C0030232', 'cui_str': 'Pallor'}, {'cui': 'C0010520', 'cui_str': 'Cyanosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C1706488', 'cui_str': 'Dorsalis pedis pulse'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0857256', 'cui_str': 'Unwell'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0277804', 'cui_str': 'Abnormal vital signs (finding)'}]",363.0,0.116758,"The revised CT MEWS observations chart improved recording of certain parameters, but did not improve nurses' ability to identify early signs of clinical deterioration and to summon assistance.","[{'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Kyriacos', 'Affiliation': 'Division of Nursing and Midwifery, Department of Health & Rehabilitation Sciences, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa. una.kyriacos@uct.ac.za.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Burger', 'Affiliation': 'Division of Nursing and Midwifery, Department of Health & Rehabilitation Sciences, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jordan', 'Affiliation': 'School of Human and Health Sciences, Swansea University, Swansea, Wales, UK.'}]",Trials,['10.1186/s13063-019-3916-0']
562,31888765,Using an incentive spirometer reduces pulmonary complications in patients with traumatic rib fractures: a randomized controlled trial.,"BACKGROUND


An incentive spirometer (IS) is a mechanical device that promotes lung expansion. It is commonly used to prevent postoperative lung atelectasis and decrease pulmonary complications after cardiac, lung, or abdominal surgery. This study explored its effect on lung function and pulmonary complication rates in patients with rib fractures.
METHODS


Between June 2014 and May 2017, 50 adult patients with traumatic rib fractures were prospectively investigated. Patients who were unconscious, had a history of chronic obstructive pulmonary disease or asthma, or an Injury Severity Score (ISS) ≥ 16 were excluded. Patients were randomly divided into a study group (n = 24), who underwent IS therapy, and a control group (n = 26). All patients received the same analgesic protocol. Chest X-rays and pulmonary function tests (PFTs) were performed on the 5th and 7th days after trauma.
RESULTS


The groups were considered demographically homogeneous. The mean age was 55.2 years and 68% were male. Mean pretreatment ISSs and mean number of ribs fractured were not significantly different (8.23 vs. 8.08 and 4 vs. 4, respectively). Of 50 patients, 28 (56%) developed pulmonary complications, which were more prevalent in the control group (80.7% vs. 29.2%; p = 0.001). Altogether, 25 patients had delayed hemothorax, which was more prevalent in the control group (69.2% vs. 29.2%; p = 0.005). Two patients in the control group developed atelectasis, one patient developed pneumothorax, and five patients required thoracostomy. PFT results showed decreased forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV 1 ) in the control group. Comparing pre- and posttreatment FVC and FEV 1 , the study group had significantly greater improvements (p < 0.001).
CONCLUSIONS


In conclusion, the use of an IS reduced pulmonary complications and improved PFT results in patients with rib fractures. The IS is a cost-effective device for patients with rib fractures and its use has clinical benefits without harmful effects.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04006587. Registered on 3 July 2019.",2019,PFT results showed decreased forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV 1 ) in the control group.,"['≥\u200916 were excluded', 'Patients who were unconscious, had a history of chronic obstructive pulmonary disease or asthma, or an Injury Severity Score (ISS', 'patients with traumatic rib fractures', 'Between June 2014 and May 2017, 50 adult patients with traumatic rib fractures', 'The mean age was 55.2\u2009years and 68% were male', 'patients with rib fractures']","['incentive spirometer', 'Chest X-rays and pulmonary function tests (PFTs', 'PFT']","['Mean pretreatment ISSs and mean number of ribs fractured', 'pulmonary complications', 'delayed hemothorax', 'thoracostomy', 'lung function and pulmonary complication rates', 'PFT results', 'forced vital capacity (FVC) and forced expiratory volume']","[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041654', 'cui_str': 'Unconscious'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0021504', 'cui_str': 'ISS Score'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0035522', 'cui_str': 'Rib Fractures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1961253', 'cui_str': 'Incentive spirometer'}, {'cui': 'C0039985', 'cui_str': 'Radiologic examination of chest'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035522', 'cui_str': 'Rib Fractures'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019123', 'cui_str': 'Hemothorax'}, {'cui': 'C0039990', 'cui_str': 'Thoracostomy'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",50.0,0.0984937,PFT results showed decreased forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV 1 ) in the control group.,"[{'ForeName': 'Shao-Kai', 'Initials': 'SK', 'LastName': 'Sum', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Chang Gung Memorial Hospital, 222 Mai-Chin Road, Keelung, 204, Taiwan, Republic of China.'}, {'ForeName': 'Ya-Chuan', 'Initials': 'YC', 'LastName': 'Peng', 'Affiliation': 'Department of Nursing, Chang Gung Memorial Hospital, Keelung, Taiwan.'}, {'ForeName': 'Shun-Ying', 'Initials': 'SY', 'LastName': 'Yin', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Chang Gung Memorial Hospital, 222 Mai-Chin Road, Keelung, 204, Taiwan, Republic of China.'}, {'ForeName': 'Pin-Fu', 'Initials': 'PF', 'LastName': 'Huang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Chang Gung Memorial Hospital, 222 Mai-Chin Road, Keelung, 204, Taiwan, Republic of China.'}, {'ForeName': 'Yao-Chang', 'Initials': 'YC', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Chang Gung Memorial Hospital, 222 Mai-Chin Road, Keelung, 204, Taiwan, Republic of China.'}, {'ForeName': 'Tzu-Ping', 'Initials': 'TP', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Chang Gung Memorial Hospital, 222 Mai-Chin Road, Keelung, 204, Taiwan, Republic of China.'}, {'ForeName': 'Heng-Hsin', 'Initials': 'HH', 'LastName': 'Tung', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Science, Taipei, Taiwan.'}, {'ForeName': 'Chi-Hsiao', 'Initials': 'CH', 'LastName': 'Yeh', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Chang Gung Memorial Hospital, 222 Mai-Chin Road, Keelung, 204, Taiwan, Republic of China. yehccl@cgmh.org.tw.'}]",Trials,['10.1186/s13063-019-3943-x']
563,31909160,Short-term clinical and serological follow-up with conventional and conformational anti-desmoglein antibodies in treatment-naïve and previously treated patients with pemphigus vulgaris after receiving rituximab.,"Background


Pemphigus vulgaris (PV) is a blistering, life-threatening autoimmune disease. Ethylenediaminetetraacetic acid (EDTA)-treated desmoglein (Dsg) enzyme-linked immunosorbent assay (ELISA) has recently been suggested to detect nonpathogenic antibodies. Rituximab (RTX) is now considered a first-line treatment for PV.
Objective


The primary and secondary aims were to evaluate anti-Dsg and EDTA-treated anti-Dsg ELISA and clinical response before and 3 months after RTX in treatment-naïve and previously treated patients, respectively. In addition, we compared the short-term efficacy of RTX between these groups.
Methods


Seventy-five patients with PV who received RTX (500 mg weekly for 4 weeks or 1000 mg 2 weeks apart) and prednisolone were followed for 3 months. Thirty-seven treatment-naïve newly diagnosed (group A) and 38 relapsed patients (group B) were included. Disease activity was scored with the Pemphigus Disease Area Index (PDAI). Clinical response was also assessed. Serum samples were collected at two points and examined for anti-Dsg1/3 and EDTA-treated anti-Dsg1/3. Conformational anti-Dsg values were calculated by subtracting EDTA-treated from conventional anti-Dsg values.
Results


The correlation of conventional and conformational anti-Dsg values was perfect (correlation coefficient > 0.98;  p  < .001) at every time point for both anti-Dsgs. There was no difference with regard to PDAI and anti-Dsg values between the two groups at baseline. The frequency of responders was significantly higher in group A (100%) than in group B (89%;  p  = .006). Three patients relapsed, and five patients had persistent disease activity in group B. After 3 months, conventional and conformational anti-Dsg values were significantly higher in group B compared with group A (anti-Dsg3:  p  = .017 and .021, respectively; anti-Dsg1:  p  = .014 and .016, respectively). Total and scalp PDAI were significantly lower in group A than in group B ( p  = .042 and .016, respectively).
Conclusion


EDTA-treated anti-Dsg ELISA had no added value. Using RTX as first-line treatment in patients with PV appears to be associated with better clinical response and immunologic profile than delayed treatment in the short term.",2019,Total and scalp PDAI were significantly lower in group A than in group B (,"['Thirty-seven treatment-naïve', 'patients with PV', 'newly diagnosed (group A) and 38 relapsed patients (group B) were included']","['Rituximab (RTX', 'RTX', 'Ethylenediaminetetraacetic acid (EDTA)-treated desmoglein (Dsg) enzyme-linked immunosorbent assay (ELISA', 'prednisolone', 'rituximab', 'conventional and conformational anti-desmoglein antibodies']","['conventional and conformational anti-Dsg values', 'Clinical response', 'PDAI and anti-Dsg values', 'evaluate anti-Dsg and EDTA-treated anti-Dsg ELISA and clinical response', 'Total and scalp PDAI', 'clinical response and immunologic profile', 'correlation of conventional and conformational anti-Dsg values', 'frequency of responders', 'Disease activity', 'persistent disease activity', 'Conformational anti-Dsg values']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0113216', 'cui_str': 'Desmogleins'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0529584', 'cui_str': 'isothiocyanatobenzyl-EDTA'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",75.0,0.036842,Total and scalp PDAI were significantly lower in group A than in group B (,"[{'ForeName': 'Hoorieh', 'Initials': 'H', 'LastName': 'Alaeen', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roja', 'Initials': 'R', 'LastName': 'Toosi', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Mahmoudi', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Balighi', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Tavakolpour', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Teimoupour', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Daneshpazhooh', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of women's dermatology,['10.1016/j.ijwd.2019.05.008']
564,31888762,The effect of co supplementation of omega-3 and vitamin D on cardio metabolic risk factors and psychological distress in reproductive-aged women with prediabetes and hypovitaminosis D: a study protocol for a randomized controlled trial.,"BACKGROUND


A prediabetic state is a risk factor for type 2 diabetes. There are no approved drugs to manage prediabetes. Among the supplements routinely used by individuals, vitamin D and omega-3 have been studied to reduce fasting blood sugar. However, their co-supplementation has not been studied in individuals with prediabetes. This randomized controlled trial is designed to determine the effects of these two supplements on fasting blood sugar, other cardio metabolic risk factors, and psychological distress in reproductive-aged women with prediabetes and hypovitaminosis D.
METHODS/DESIGN


This 2 × 2 factorial, triple-blind, randomized, placebo-controlled, clinical trial will be done on 168 women of reproductive age diagnosed with prediabetes and hypovitaminosis D. Participants will be randomly assigned equally to four groups: (1) 1000 mg omega-3 fatty acid twice a day + vitamin D placebo every two weeks; (2) omega-3 fatty acid placebo twice a day + 50,000 IU vitamin D every two weeks; (3) 1000 mg omega-3 fatty acid twice a day + 50,000 IU vitamin D every two weeks; (4) omega-3 fatty acid placebo twice a day + vitamin D placebo every two weeks for eight weeks. At the beginning, participants will provide a self-reported questionnaire on the sociodemographic characteristics. At baseline and post-intervention visits, physical activity, Depression Anxiety Stress Scale 21 and Pittsburgh Sleep Quality Index, and a three-day food record will be collected for each individual. Blood pressure, weight, height, and waist circumference will also be measured. At the beginning and at the end, a blood sample will be used for estimating serum glucose indices (fasting blood sugar and insulin, homeostasis model assessment-insulin resistance, homeostasis model assessment-beta cell function), lipids (triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol), and vitamin D status. Data analysis using Kolmogorov-Smirnov test, paired t-test, one-way analysis of variance, and repeated measures analysis of variance will be conducted through SPSS-24 software.
DISCUSSION


The primary aim of the present trial is to determine the effect of vitamin D and/or omega-3 on glycemic indices, lipid profiles, psychological distress, blood pressure, and anthropometric indices in prediabetic women with hypovitaminosis D. The results from this trial will provide evidence on the efficacy of these two supplements for preventing or delaying the onset of type 2 diabetes in high-risk individuals.
TRIAL REGISTRATION


Iran Clinical Trials Registry, IRCT20100130003226N17. Registered on 9 February 2019.",2019,"At baseline and post-intervention visits, physical activity, Depression Anxiety Stress Scale 21 and Pittsburgh Sleep Quality Index, and a three-day food record will be collected for each individual.","['individuals with prediabetes', 'reproductive-aged women with prediabetes and hypovitaminosis D', 'prediabetic women with hypovitaminosis D', '168 women of reproductive age diagnosed with prediabetes and hypovitaminosis']","['omega-3 and vitamin D', 'placebo', 'omega-3 fatty acid twice a day + vitamin D placebo', 'vitamin D and/or omega-3', 'omega-3 fatty acid twice a day +\u200950,000 IU vitamin D every two weeks; (4) omega-3 fatty acid placebo twice a day + vitamin D placebo', 'omega-3 fatty acid placebo']","['serum glucose indices (fasting blood sugar and insulin, homeostasis model assessment-insulin resistance, homeostasis model assessment-beta cell function), lipids (triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol), and vitamin D status', 'physical activity, Depression Anxiety Stress Scale 21 and Pittsburgh Sleep Quality Index', 'fasting blood sugar, other cardio metabolic risk factors, and psychological distress', 'cardio metabolic risk factors and psychological distress', 'Blood pressure, weight, height, and waist circumference', 'glycemic indices, lipid profiles, psychological distress, blood pressure, and anthropometric indices']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1510471', 'cui_str': 'Vitamin Deficiency'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}]","[{'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}]",168.0,0.641602,"At baseline and post-intervention visits, physical activity, Depression Anxiety Stress Scale 21 and Pittsburgh Sleep Quality Index, and a three-day food record will be collected for each individual.","[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Rajabi-Naeeni', 'Affiliation': 'Midwifery and Reproductive Health Research Center, Department of midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahrokh', 'Initials': 'M', 'LastName': 'Dolatian', 'Affiliation': 'Midwifery and Reproductive Health Research Center, Department of midwifery and Reproductive Health, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. mhdolatian@gmail.com.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Qorbani', 'Affiliation': 'Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Amir Abbas', 'Initials': 'AA', 'LastName': 'Vaezi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran.'}]",Trials,['10.1186/s13063-019-3948-5']
565,6388905,A double blind controlled trial to study the effects of vaginal prostaglandin pessaries on induction of labour and improvement in the favourability of the cervix.,"In a double blind trial of prostaglandin pessaries to induce labour, prostaglandins were successful in 47.5% of primiparous and 70.6% of multiparous patients. Of the 66% who did not go into labour this was successfully induced by artificial rupture of the membranes and oxytocin infusion in all but two cases irrespective of whether or not they received the active compound. This trial suggests that prostaglandin pessaries are a useful and very acceptable way of inducing labour and that although they make the cervix more ""favourable"" they do not significantly alter the outcome of labour. In the light of their high cost it is time that this method of induction and its timing was re-evaluated.",1984,Of the 66% who did not go into labour this was successfully induced by artificial rupture of the membranes and oxytocin infusion in all but two cases irrespective of whether or not they received the active compound.,['47.5% of primiparous and 70.6% of multiparous patients'],"['prostaglandin pessaries', 'vaginal prostaglandin pessaries']",['favourability of the cervix'],"[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0026751', 'cui_str': 'Multiparity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0031246', 'cui_str': 'Pessaries'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}]",,0.216072,Of the 66% who did not go into labour this was successfully induced by artificial rupture of the membranes and oxytocin infusion in all but two cases irrespective of whether or not they received the active compound.,"[{'ForeName': 'Y A', 'Initials': 'YA', 'LastName': 'Patel', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
566,31865534,"Influence of regular aspirin intake on PSA values, prostate cancer incidence and overall survival in a prospective screening trial (ERSPC Aarau).","OBJECTIVES


To analyze the influence of aspirin (ASA) intake on PSA values and prostate cancer (PCa) development in a prospective screening study cohort.
METHODS


4314 men from the Swiss section of the European Randomized Study of Screening for Prostate Cancer (ERSPC) were included. A transrectal prostate biopsy was performed in men with a PSA level ≥ 3 ng/ml. Mortality data were obtained through registry linkages. PCa incidence and grade, total PSA, free-to-total PSA and overall survival were compared between ASA users and non-users.
RESULTS


Median follow-up time was 9.6 years. In 789 men (18.3%) using aspirin [ASA +], the overall PCa incidence was significantly lower (6.8% vs. 9.6%, p = 0.015), but the multivariate Cox regression analysis showed no significant decrease in risk of PCa diagnosis (HR 0.84, p = 0.297). Total PSA values were significantly lower in ASA users for both baseline (1.6 vs. 1.8 ng/ml, p = 0.007) and follow-up visits (1.75 vs. 2.1 ng/ml, p < 0.001). Multivariate Cox regression analysis predicted significantly higher overall mortality risk among ASA users (HR 1.46, p = 0.009).
CONCLUSIONS


In our study population, PCa incidence was significantly reduced among patients on aspirin. While we did not observe a statistically significant PCa risk reduction during the follow-up period, we found lower PSA values among ASA users compared to non-users, with a more distinct difference after 4 years of ASA intake, suggesting a cumulative effect and a potential protective association between regular ASA intake and PCa development. As for clinical practice, lowering PSA cutoff values by 0.4 ng/ml could be considered in long-term ASA users to avoid a potential bias towards delayed PCa detection.",2020,"PCa incidence and grade, total PSA, free-to-total PSA and overall survival were compared between ASA users and non-users.
","['4314 men from the Swiss section of the European Randomized Study of Screening for Prostate Cancer (ERSPC) were included', 'men with a PSA level\u2009≥']","['regular aspirin intake', 'aspirin', 'transrectal prostate biopsy', 'aspirin (ASA) intake']","['PSA values and prostate cancer (PCa) development', 'PSA values', 'PCa incidence and grade, total PSA, free-to-total PSA and overall survival', 'Total PSA values', 'risk of PCa diagnosis', 'overall mortality risk', 'PCa incidence', 'Mortality data', 'PCa risk reduction', 'PSA values, prostate cancer incidence and overall survival', 'overall PCa incidence']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",789.0,0.289707,"PCa incidence and grade, total PSA, free-to-total PSA and overall survival were compared between ASA users and non-users.
","[{'ForeName': 'Lukas Werner', 'Initials': 'LW', 'LastName': 'Prause', 'Affiliation': 'Department of Urology, University Hospital Zurich, Zurich, Switzerland. lukas.prause@gmail.com.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Manka', 'Affiliation': 'Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany. l.manka@klinikum-braunschweig.de.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Millan', 'Affiliation': 'Department of Urology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Lang', 'Affiliation': 'Department of Urology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Wyler', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Grobholz', 'Affiliation': 'Institute of Pathology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hammerer-Lercher', 'Affiliation': 'Department of Laboratory Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Tullio', 'Initials': 'T', 'LastName': 'Sulser', 'Affiliation': 'Department of Urology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Recker', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kwiatkowski', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eberli', 'Affiliation': 'Department of Urology, University Hospital Zurich, Zurich, Switzerland.'}]",World journal of urology,['10.1007/s00345-019-03054-5']
567,31888723,Results and lessons learnt from a randomized controlled trial: prophylactic treatment of vestibular migraine with metoprolol (PROVEMIG).,"BACKGROUND


Vestibular migraine (VM) is the most frequent cause of recurrent spontaneous attacks of vertigo causally related to migraine. The objective of the Prophylactic treatment of vestibular migraine with metoprolol (PROVEMIG) trial was to demonstrate that metoprolol succinate is superior to placebo in the prevention of episodic vertigo- and migraine-related symptoms in patients with VM.
METHODS


This phase III, two-arm, parallel-group, double-blind, randomized placebo-controlled trial was designed to be conducted at tertiary referral centres at neurology and ear, nose and throat departments of eight German university hospitals. The planned sample size was a total of 266 patients to be allocated. Adults aged 18 years or above diagnosed with probable or definitive VM according to the Neuhauser criteria 2001 were randomly assigned 1:1 to 6 months blinded metoprolol (maintenance dosage of 95 mg daily) or placebo. The primary efficacy outcome was the self-reported number of vertiginous attacks per 30 days documented by means of a paper-based daily symptom diary. The pre-specified time period of primary interest was defined as months 4 to 6. Secondary outcomes included the patient-reported number of migraine days and vertigo days, the Dizziness Handicap Inventory, and clinical assessments. Adverse events were reported throughout the whole 9-month study period.
RESULTS


At the time of trial termination, no evidence for a difference in the incidence of vertiginous attacks between groups was detected. For the full analysis set, the incidence rate ratio was 0.983 (95% confidence interval (CI) 0.902-1.071) for metoprolol versus placebo. In both groups, there was a significant decline over time in the overall monthly vertigo attacks by a factor of 0.830 (95% CI 0.776-0.887). Results were consistent for all subjective and objective key measures of efficacy. The treatment was well tolerated with no unexpected safety findings.
CONCLUSIONS


After randomizing 130 patients PROVEMIG had to be discontinued because of poor participant accrual not related to the tolerability of the study medication or safety concerns; no treatment benefit of metoprolol over placebo could be established. Additional preparatory work is much needed in the development, psychometric evaluation and interpretation of clinically meaningful end points in trials on episodic syndromes like VM taking into consideration the complexity of this disease entity comprising two domains (vertigo- and headache-related disability).
TRIAL REGISTRATION


EudraCT, 2009-013701-34. Prospectively registered on 8 April 2011.",2019,"At the time of trial termination, no evidence for a difference in the incidence of vertiginous attacks between groups was detected.","['patients with VM', 'Adults aged 18\u2009years or above diagnosed with probable or definitive VM according to the Neuhauser criteria 2001', 'conducted at tertiary referral centres at neurology and ear, nose and throat departments of eight German university hospitals', '266 patients to be allocated']","['metoprolol over placebo', 'metoprolol (maintenance dosage of 95\u2009mg daily) or placebo', 'placebo', 'metoprolol', 'metoprolol succinate']","['incidence of vertiginous attacks', 'incidence rate ratio', 'overall monthly vertigo attacks', 'self-reported number of vertiginous attacks per 30\u2009days documented by means of a paper-based daily symptom diary', 'Adverse events', 'patient-reported number of migraine days and vertigo days, the Dizziness Handicap Inventory, and clinical assessments']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0587514', 'cui_str': 'Ear, nose and throat department (environment)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0724633', 'cui_str': 'metoprolol succinate'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",2001.0,0.565363,"At the time of trial termination, no evidence for a difference in the incidence of vertiginous attacks between groups was detected.","[{'ForeName': 'Otmar', 'Initials': 'O', 'LastName': 'Bayer', 'Affiliation': 'German Center for Vertigo and Balance Disorders (DSGZ), Ludwig Maximilians University, Campus Grosshadern, Munich, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Adrion', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig Maximilians University, Campus Grosshadern, Marchioninistr. 15, 81377, Munich, Germany. adrion@ibe.med.uni-muenchen.de.'}, {'ForeName': 'Amani', 'Initials': 'A', 'LastName': 'Al Tawil', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig Maximilians University, Campus Grosshadern, Marchioninistr. 15, 81377, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology (IBE), Ludwig Maximilians University, Campus Grosshadern, Marchioninistr. 15, 81377, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Strupp', 'Affiliation': 'German Center for Vertigo and Balance Disorders (DSGZ), Ludwig Maximilians University, Campus Grosshadern, Munich, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3903-5']
568,30951920,Sexual Function following Laparoscopic versus Transvaginal Closure of the Vaginal Vault after Laparoscopic Hysterectomy: Secondary Analysis of a Randomized Trial by the Italian Society of Gynecological Endoscopy Using a Validated Questionnaire.,"STUDY OBJECTIVE


The effect of the different types of vaginal cuff closures on posthysterectomy sexual function has not been investigated in depth. We evaluated if there is a difference between transvaginal versus a laparoscopic closure after total laparoscopic hysterectomy (TLH) on female sexual function, using a validated questionnaire.
DESIGN


Secondary analysis of a prospective randomized controlled trial.
SETTING


Three academic research centers.
PATIENTS


Women consenting to telephone interviews on their sexual life before and after undergoing TLH were included.
INTERVENTIONS


Patients were randomly assigned to a laparoscopic or transvaginal approach for vaginal cuff closure at the end of TLH for benign indications.
MEASUREMENTS AND MAIN RESULTS


A validated questionnaire (the Female Sexual Function Index [FSFI]) was used to explore sexuality before and after the operation. Of the 1408 patients enrolled in the primary study, 400 patients were asked to complete the questionnaire. Of them, 182 (41.4%) were eligible and accepted enrollment in the present analysis. No difference was found in terms of pre- and postoperative FSFI scores between groups. Patients with a low preoperative FSFI score (<26.55) had a significantly higher likelihood of having a postoperative sexual disorder (p <.001). Women who received bilateral adnexectomy before menopause and those with postoperative vaginal cuff hematoma had a significantly lower postoperative FSFI score (p = .001 and p = .04, respectively). After multivariable analysis, both variables maintained at least a tendency toward an association with a lower postoperative FSFI score (odds ratio, 2.696; 95% confidence interval, 1.010-7.194; p = 0.048 and p = 0.053; odds ratio, 13.2; 95% confidence interval, .966-180.5, respectively).
CONCLUSION


Transvaginal and laparoscopic cuff closures after TLH have similar sexual postoperative outcomes. A patient with sexual problems before TLH is more likely to have a low FSFI score postoperatively. Premenopausal patients undergoing bilateral ovariectomy and those with postoperative vaginal cuff hematoma have a worse postoperative sexual life. (Clinicaltrials.gov, protocol number NCT02453165, registration date May 25, 2015.).",2020,"Women who received bilateral adnexectomy before menopause and those with postoperative vaginal cuff hematoma had a significantly lower postoperative FSFI score (p = .001 and p = .04, respectively).","['Three academic research centers', '1408 patients enrolled in the primary study, 400 patients', 'Women consenting to telephone interviews on their sexual life before and after undergoing TLH were included', 'Premenopausal patients undergoing bilateral ovariectomy and those with postoperative vaginal cuff hematoma']","['vaginal cuff closures', 'Laparoscopic versus Transvaginal Closure of the Vaginal Vault after Laparoscopic Hysterectomy', 'laparoscopic or transvaginal approach', 'transvaginal versus a laparoscopic closure after total laparoscopic hysterectomy (TLH']","['low preoperative FSFI score', 'likelihood of having a postoperative sexual disorder', 'pre- and postoperative FSFI scores', 'postoperative FSFI score', 'postoperative sexual life', 'Sexual Function']","[{'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0278321', 'cui_str': 'Castration, Female'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}]","[{'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0549115', 'cui_str': 'Structure of vaginal vault'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}]",400.0,0.261765,"Women who received bilateral adnexectomy before menopause and those with postoperative vaginal cuff hematoma had a significantly lower postoperative FSFI score (p = .001 and p = .04, respectively).","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Uccella', 'Affiliation': 'Obstetrics and Gynecology Department (Drs. Uccella, Ferrari, and Zorzato), Ospedale degli Infermi, Biella, Italy; Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy. Electronic address: stefucc@libero.it.'}, {'ForeName': 'Vito Andrea', 'Initials': 'VA', 'LastName': 'Capozzi', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy; Obstetrics and Gynecology Department (Drs. Capozzi and Berretta), University of Parma, Parma, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': ""Ricco'"", 'Affiliation': ""Service for Health and Safety on the Workplaces (Dr. Ricco'), AUSL - I.R.C.C.S. di Reggio Emilia, Italy.""}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Perrone', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Zanello', 'Affiliation': ""Minimally Invasive Gynecological Surgery Unit (Drs. Zanello and Seracchioli), Sant'Orsola-Malpighi Hospital, Bologna, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'Obstetrics and Gynecology Department (Drs. Uccella, Ferrari, and Zorzato), Ospedale degli Infermi, Biella, Italy.'}, {'ForeName': 'Pier Carlo', 'Initials': 'PC', 'LastName': 'Zorzato', 'Affiliation': 'Obstetrics and Gynecology Department (Drs. Uccella, Ferrari, and Zorzato), Ospedale degli Infermi, Biella, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Seracchioli', 'Affiliation': ""Minimally Invasive Gynecological Surgery Unit (Drs. Zanello and Seracchioli), Sant'Orsola-Malpighi Hospital, Bologna, Italy.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Cromi', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Cromi, Serati, and Ghezzi), University of Insubria, Del Ponte Hospital, Varese, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Serati', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Cromi, Serati, and Ghezzi), University of Insubria, Del Ponte Hospital, Varese, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Ergasti', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fanfani', 'Affiliation': 'Department of Medicine and Aging Sciences (Dr. Fanfani), University ""Gabriele d\'Annunzio"" of Chieti-Pescara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Berretta', 'Affiliation': 'Obstetrics and Gynecology Department (Drs. Capozzi and Berretta), University of Parma, Parma, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Malzoni', 'Affiliation': 'Endoscopica Malzoni-Center for Advanced Endoscopic Gynecological Surgery (Dr. Malzoni), Avellino, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cianci', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Vizza', 'Affiliation': 'Department of Oncological Surgery, Gynecologic Oncologic Unit (Dr. Vizza), ""Regina Elena"" National Cancer Institute, IRCCS, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Guido', 'Affiliation': 'Division of Gynaecology, Department of Obstetrics and Gynaecology (Drs. Guido and Legge), ""F. Miulli"" General Hospital, Acquaviva delle Fonti, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Legge', 'Affiliation': 'Division of Gynaecology, Department of Obstetrics and Gynaecology (Drs. Guido and Legge), ""F. Miulli"" General Hospital, Acquaviva delle Fonti, Bari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Ciravolo', 'Affiliation': 'Department of Obstetrics and Gynecology (Dr. Ciravolo), Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Gueli Alletti', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ghezzi', 'Affiliation': 'Department of Obstetrics and Gynecology (Drs. Cromi, Serati, and Ghezzi), University of Insubria, Del Ponte Hospital, Varese, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Candiani', 'Affiliation': 'Gynecology Department (Dr. Candiani), IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Department of Woman and Child Health (Drs. Uccella, Capozzi, Perrone, Ergasti, Cianci, Alletti, and Scambia), Fondazione Policlinico Gemelli, IRCCS, Rome, Italy.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.03.018']
569,31888744,Effects of perioperative transcutaneous electrical acupoint stimulation on monocytic HLA-DR expression in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass: study protocol for a double-blind randomized controlled trial.,"BACKGROUND


Cardiac surgery involving cardiopulmonary bypass (CPB) is known to be associated with a transient postoperative immunosuppression. When severe and persistent, this immune dysfunction predisposes patients to infectious complications, which contributes to a prolonged stay in the intensive care unit (ICU), and even mortality. Effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture-related techniques, such as electroacupuncture and transcutaneous electrical acupoint stimulation (TEAS), are able to produce effective cardioprotection and immunomodulation in adult and pediatric patients undergoing cardiac surgery with CPB, which leads to enhanced recovery. However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post-cardiosurgical conditions is unknown. Thus, as a preliminary study, the main objective is to evaluate the effects of TEAS on the postoperative expression of monocytic human leukocyte antigen (-D related) (mHLA-DR), a standardized ""global"" biomarker of injury or sepsis-associated immunosuppression, in patients receiving on-pump coronary artery bypass grafting (CABG).
METHODS


This study is a single-center clinical trial. The 88 patients scheduled to receive CABG under CPB will be randomized into two groups: the group receiving TEAS, and the group receiving transcutaneous acupoint pseudo-electric stimulation (Sham TEAS). Expression of mHLA-DR serves as a primary endpoint, and other laboratory parameters (e.g., interleukin [IL]-6, IL-10) and clinical outcomes (e.g., postoperative infectious complications, ICU stay time, and mortality) as the secondary endpoints. In addition, immune indicators, such as high mobility group box 1 protein and regulatory T cells will also be measured.
DISCUSSION


The current study is a preliminary monocentric clinical trial with a non-clinical primary endpoint, expression of mHLA-DR, aiming at determining whether perioperative application of TEAS has a potential to reverse CABG-associated immunosuppression. Although the immediate clinical impact of this study is limited, its results would inform further large-sample clinical trials using relevant patient-centered clinical outcomes as primary endpoints.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02933996. Registered on 13 October 2016.",2019,"However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post-cardiosurgical conditions is unknown.","['adult and pediatric patients undergoing cardiac surgery with CPB', 'patients receiving on-pump coronary artery bypass grafting (CABG', '88 patients scheduled to receive CABG under CPB', 'patients undergoing coronary artery bypass grafting with cardiopulmonary bypass']","['electroacupuncture and transcutaneous electrical acupoint stimulation (TEAS', 'perioperative transcutaneous electrical acupoint stimulation', 'TEAS, and the group receiving transcutaneous acupoint pseudo-electric stimulation (Sham TEAS', 'Cardiac surgery involving cardiopulmonary bypass (CPB', 'TEAS']","['postoperative infectious complications, ICU stay time, and mortality', 'monocytic HLA-DR expression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.213003,"However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post-cardiosurgical conditions is unknown.","[{'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Anesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Wei', 'Affiliation': 'Guangdong Cardiovascular Institute & Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Anesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Deng-Wen', 'Initials': 'DW', 'LastName': 'Zhang', 'Affiliation': 'Guangdong Cardiovascular Institute & Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Anesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Anesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yong', 'Affiliation': 'Anesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Anesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Ya-Lan', 'Initials': 'YL', 'LastName': 'Zhou', 'Affiliation': 'Anesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Anesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Guo-Qiang', 'Initials': 'GQ', 'LastName': 'Fu', 'Affiliation': 'Anesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Guangdong Cardiovascular Institute & Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong Province, China. shengwang_gz@163.com.'}, {'ForeName': 'Jian-Gang', 'Initials': 'JG', 'LastName': 'Song', 'Affiliation': 'Anesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. songjg1993@126.com.'}]",Trials,['10.1186/s13063-019-3889-z']
570,31319786,Impact of a tobacco cessation intervention on adherence to tobacco use treatment guidelines among village health workers in Vietnam.,"Community health workers (in Vietnam referred to as village health workers) have the potential to play a key role in expanding access to evidence-based tobacco use treatment. We conducted a cluster randomized controlled trial in community health centers in Vietnam that compared the effect of provider advice and cessation assistance (i.e. brief counseling and patient education materials) (BC) vs. BC + three sessions of in-person counseling delivered by a village health worker (BC+R) on providers' and village health workers' adherence to tobacco use treatment guidelines. All village health workers and health care providers received training. This paper presents data on the effect of the intervention on village health workers' adherence to tobacco use treatment guidelines, including asking about tobacco use, advising smokers to quit, offering assistance and their attitude, norms, and self-efficacy related to tobacco use treatment. We examined changes in adherence to tobacco use treatment guidelines before and 12 months after the intervention among 89 village health workers working in the 13 community health centers enrolled in the BC+R study condition. Village health workers' adherence to tobacco use treatment guidelines increased significantly. Village health workers were more likely to ask about tobacco use (3.4% at baseline, 32.6% at 12 months), offer advice to quit (4.5% to 48.3%) and offer assistance (1.1% to 38.2%). Perceived barriers to treating tobacco use decreased significantly. Self-efficacy and attitudes towards treating tobacco use improved significantly. Increased adherence to tobacco use treatment guidelines was associated with positive attitudes towards their role in delivering tobacco use treatment and increasing awareness of the community health center smoke-free policy. The findings suggest that, with training and support systems, village health workers can extend their role to include smoking cessation services. This workforce could represent a sustainable resource for supporting smokers who wish to quit.",2020,Increased adherence to tobacco use treatment guidelines was associated with positive attitudes towards their role in delivering tobacco use treatment and increasing awareness of the community health center smoke-free policy.,"['village health workers', 'Village health workers', 'Community health workers (in Vietnam referred to as village health workers', 'All village health workers and health care providers', 'community health centers in Vietnam', 'village health workers in Vietnam', '89 village health workers working in the 13 community health centers enrolled in the BC+R study condition']","['tobacco cessation intervention', 'provider advice and cessation assistance (i.e. brief counseling and patient education materials) (BC) vs. BC + three sessions of in-person counseling delivered by a village health worker (BC+R']","['Self-efficacy and attitudes towards treating tobacco', 'advice to quit']","[{'cui': 'C0087157', 'cui_str': 'Village Health Workers'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0087157', 'cui_str': 'Village Health Workers'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}]",,0.0448543,Increased adherence to tobacco use treatment guidelines was associated with positive attitudes towards their role in delivering tobacco use treatment and increasing awareness of the community health center smoke-free policy.,"[{'ForeName': 'Nam', 'Initials': 'N', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Van', 'Initials': 'V', 'LastName': 'Truong', 'Affiliation': 'Institute of Social Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dang', 'Affiliation': 'Institute of Social Medical Studies, Hanoi, Vietnam.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Siman', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shelley', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York, NY, USA.'}]",Global health promotion,['10.1177/1757975919854032']
571,31337518,Adherence to lifestyle changes after coronary artery bypass graft: Outcome of preoperative peer education.,"OBJECTIVE


This study was done to investigate the effect of preoperative peer education on patients' adherence to medication and lifestyle changes after Coronary Artery Bypass Graft (CABG).
METHODS


In this randomized clinical trial, the peers of CABG patients conducted preoperative educational sessions at the ward in groups of 4-5 (n = 36) while the control group (n = 34) received routine education by a nurse. Adherence of both groups to medication and recommendations for lifestyle modification including physical activity, smoking, and diet was measured one and two months after discharge.
RESULTS


A multivariate analysis of co-variance showed the significant effect of peer education on adherence (F = 32.586, p < 0.001; η 2  = 0.671). Univariate ANCOVA revealed a significant difference in adherence to diet between the two groups (F = 62.316, p = 0 0.0001; η 2  = 0.482). Based on the repeated measures ANOVA, peer education significantly improved the CABG patients' adherence to diet (F = 55.373, p = 0.0001) and their total adherence (F = 9.911, p = 0.002) compared to the control group.
CONCLUSION


Preoperative peer education had a significant effect on improving CABG patients' adherence to lifestyle changes after hospital discharge.
PRACTICE IMPLICATION


Peer education can be used as an effective method to improve the CABG patients ' adherence to lifestyle changes.",2019,"A multivariate analysis of co-variance showed the significant effect of peer education on adherence (F = 32.586, p < 0.001; η 2  = 0.671).","['peers of CABG patients conducted preoperative educational sessions at the ward in groups of 4-5 (n\u202f=\u202f36) while the control group (n\u202f=\u202f34) received', ""patients' adherence to medication and lifestyle changes after Coronary Artery Bypass Graft (CABG""]","['preoperative peer education', 'routine education by a nurse']","['total adherence', ""CABG patients' adherence to diet"", 'adherence to diet']","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]",,0.0283664,"A multivariate analysis of co-variance showed the significant effect of peer education on adherence (F = 32.586, p < 0.001; η 2  = 0.671).","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Golaghaie', 'Affiliation': 'Department of Community Health Nursing, Arak University of Medical Sciences, Arak, Iran. Electronic address: golaghaei@arakmu.ac.ir.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Esmaeili-Kalantari', 'Affiliation': 'Student Research Committee, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mahmoodreza', 'Initials': 'M', 'LastName': 'Sarzaeem', 'Affiliation': 'Department of Cardiovascular Surgery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rafiei', 'Affiliation': 'Department of Biostatistics & Epidemiology, School of health, Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Patient education and counseling,['10.1016/j.pec.2019.07.019']
572,30487561,Wine and Health-New Evidence.,"Health benefits of moderate wine consumption have been studied during the past decades, first in observational studies and more recently, in experimental settings and randomized controlled studies. Suggested biological pathways include antioxidant, lipid regulating, and anti-inflammatory effects. Both the alcoholic and polyphenolic components of wine are believed to contribute to these beneficial effects. Although several of these studies demonstrated protective associations between moderate drinking and cardiovascular disease, atherosclerosis, hypertension, certain types of cancer, type 2 diabetes, neurological disorders, and the metabolic syndrome, no conclusive recommendations exist regarding moderate wine consumption. Yet, it is suggested that the physician and patient should discuss alcohol use. In the CASCADE (CArdiovaSCulAr Diabetes & Ethanol) trial, 224 abstainers with type 2 diabetes were randomized to consume red wine, white wine or mineral water for two years. Here, we summarize our previous findings, offer new evidence concerning the differential effects of wine consumption among men and women, and further suggest that initiating moderate alcohol consumption among well-controlled persons with type 2 diabetes is apparently safe, in regard to changes in heart rate variability and carotid plaque formation.",2019,"In the CASCADE (CArdiovaSCulAr Diabetes & Ethanol) trial, 224 abstainers with type 2 diabetes were randomized to consume red wine, white wine or mineral water for two years.","['men and women', '224 abstainers with type 2 diabetes']","['consume red wine, white wine or mineral water for two years']",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0349371', 'cui_str': 'Red wine (substance)'}, {'cui': 'C0349372', 'cui_str': 'White wine (substance)'}, {'cui': 'C0026157', 'cui_str': 'Mineral Waters'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],224.0,0.0261421,"In the CASCADE (CArdiovaSCulAr Diabetes & Ethanol) trial, 224 abstainers with type 2 diabetes were randomized to consume red wine, white wine or mineral water for two years.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Golan', 'Affiliation': 'Ben-Gurion University of the Negev, Beer Sheva, Israel. golanra@bgu.ac.il.'}, {'ForeName': 'Yftach', 'Initials': 'Y', 'LastName': 'Gepner', 'Affiliation': 'Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0309-5']
573,31319192,"Dexmedetomidine to facilitate non-invasive ventilation after blunt chest trauma: A randomised, double-blind, crossover, placebo-controlled pilot study.","BACKGROUND


Although non-invasive ventilation (NIV) is recommended in patients with chest trauma, this procedure may expose to discomfort and even failure due to agitation or excessive pain. We tested the impact of dexmedetomidine on the duration of the first session of NIV.
METHODS


This randomised, crossover study enrolled 19 patients with blunt chest trauma who needed NIV. During one cycle comprising two NIV sessions, patients received in a random order an intravenous infusion of dexmedetomidine (0.7mcg/kg/h) and placebo (saline solution) that was initiated 60min prior to NIV. Dexmedetomidine (or placebo) was titrated to maintain a Richmond Agitation Sedation Scale (RASS) score between 0 and -3. A 6-h washout period was observed between NIV sessions. The reproducibility of the drug-related effects was tested during a second cycle of two NIV sessions.
RESULTS


During the first cycle, dexmedetomidine prolonged the duration of NIV compared to placebo: 280min (118-450) (median, 25-75th quartiles) versus 120min (68-287) respectively, corresponding to a median increased duration of 96min (12-180) (P=0.03). Dexmedetomidine was associated with a lower score for RASS: -0.8 (-1.0;0.0) versus 0.0 (-0.5;0.0) (P<0.01), and reduced respiratory discomfort according to the 10cm visual similar scale: 0.6cm (0.0-3.0) versus 2.2cm (0.0-5.3) (P=0.05). Pain scores, morphine consumption, and blood gas measurements were comparable between groups. No difference in the duration of non-invasive ventilation was found during the second cycle.
CONCLUSIONS


In this pilot trial, dexmedetomidine could facilitate the acceptance of the first session of non-invasive ventilation for patients with chest trauma.",2019,"In this pilot trial, dexmedetomidine could facilitate the acceptance of the first session of non-invasive ventilation for patients with chest trauma.","['19 patients with blunt chest trauma who needed NIV', 'patients with chest trauma', 'blunt chest trauma']","['placebo (saline solution', 'placebo', 'Dexmedetomidine', 'dexmedetomidine', 'invasive ventilation (NIV', 'Dexmedetomidine (or placebo']","['duration of NIV', 'duration of non-invasive ventilation', 'respiratory discomfort', 'Richmond Agitation Sedation Scale (RASS) score', 'Pain scores, morphine consumption, and blood gas measurements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}]",19.0,0.20131,"In this pilot trial, dexmedetomidine could facilitate the acceptance of the first session of non-invasive ventilation for patients with chest trauma.","[{'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Deletombe', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Grenoble Alpes University Hospital, 38000 Grenoble, France.'}, {'ForeName': 'Thibaut', 'Initials': 'T', 'LastName': 'Trouve-Buisson', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Grenoble Alpes University Hospital, 38000 Grenoble, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Godon', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Grenoble Alpes University Hospital, 38000 Grenoble, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Falcon', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Grenoble Alpes University Hospital, 38000 Grenoble, France.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Giorgis-Allemand', 'Affiliation': 'INSERM, Clinical Research Centre 1406, 38000 Grenoble, France; Grenoble Alpes University, Clinical Research Centre 1406, 38000 Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bouzat', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Grenoble Alpes University Hospital, 38000 Grenoble, France; INSERM, U1216, 38000 Grenoble, France; Grenoble Alpes University, Grenoble Institut Neurosciences (GIN), 38000 Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'INSERM, Clinical Research Centre 1406, 38000 Grenoble, France; Grenoble Alpes University, Clinical Research Centre 1406, 38000 Grenoble, France; Grenoble Alpes University, CNRS, TIMC, IMAG UMR, 5525-ThEMAS, 38000 Grenoble, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Payen', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Grenoble Alpes University Hospital, 38000 Grenoble, France; INSERM, U1216, 38000 Grenoble, France; Grenoble Alpes University, Grenoble Institut Neurosciences (GIN), 38000 Grenoble, France. Electronic address: jfpayen@univ-grenoble-alpes.fr.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2019.06.012']
574,31336212,Comparison of latency and efficacy of twin mix and modified twin mix in impacted mandibular third molar surgery - A Preliminary Randomized Triple Blind Split Mouth Clinical Study.,"INTRODUCTION


Intra-space drug administration have recently gained popularity in the clinical practice posing several advantages over the conventional routes of drug administration. A preliminary prospective randomized triple blind clinical study was conducted to compare the latency and duration of anesthesia with twin mix (1.8ml 2% lignocaine with 1:200,000 epinephrine and 1ml/4mg dexamethasone) and modified twin mix (1.7ml of 4% articaine with 1:100,000 epinephrine and 1ml/4mg dexamethasone) to two conventional local anesthesia solutions along with co-relation of clinical effects in the postoperative phase in patients undergoing extraction of impacted mandibular third molars in terms of patients comfort post-surgery.
MATERIALS AND METHODS


The study was conducted among 20 patients with bilateral impacted mandibular third molars who were randomly allotted to two groups, Group A and B. Each patients in both the groups was allotted with study and control site. Among Group A, patients were further divided into Sub-group L (Control) and Sub-group TM (Twin Mix). Group B patients were divided as Sub-group A (Control) and sub-group MTM (Modified Twin Mix). Sub-group L patients received 1.8ml of 2% lignocaine with 1:200,000 adrenaline and sub-group TM received twin mix. Sub-group A received 1.7ml of 4% articaine with 1:100,000 adrenaline and sub-group MTM received modified twin mix solution. All the procedure was performed by a single operator with a gap of 1 month between the two interventions among both the groups. Various subjective and objective parameters were measured pre-operatively and postoperatively to assess the latency and efficacy of various anesthesia solutions used in this study for third molar removal.
RESULTS


Mean (±SD) VAS scores for sting on injection and pain were found to be less in TM and MTM sub-group with a score of 2.3 (±0.768) and 2.7 (±0.065) respectively. The anesthetic latency was significantly less in sub-group TM, with a mean (±SD) of 52.4 (±28.3) seconds. Sub-groups A and MTM had longer latency of anesthesia when compared with L and TM sub-groups. The duration of soft tissue anesthesia was maximum in sub-group MTM as compared to the other sub-groups. Patients from control sub-groups among both the groups had increased swelling, post-surgical pain and trismus postoperatively.
DISCUSSION


Intra-space administration of twin mix and modified twin mix is clinically efficacious in impacted mandibular third molars surgery with better clinical outcomes postoperatively. We observed one significant difference between TM and MTM that the latter solution provided a prolonged duration of anesthesia increasing the patient's comfort postoperatively after surgical removal of mandibular third molars.",2020,VAS scores for sting on injection and pain were found to be less in TM and MTM sub-group with a score of 2.3 (±0.768) and 2.7 (±0.065) respectively.,"['patients undergoing extraction of impacted mandibular third molars in terms of patients comfort post-surgery', '20 patients with bilateral impacted mandibular third molars']","['Sub-group A (Control) and sub-group MTM (Modified Twin Mix', 'articaine with 1:100,000 adrenaline and sub-group MTM received modified twin mix solution', 'twin mix and modified twin mix', 'anesthesia with twin mix (1.8ml 2% lignocaine with 1:200,000 epinephrine and 1ml/4mg dexamethasone) and modified twin mix (1.7ml of 4% articaine with 1:100,000 epinephrine and 1ml/4mg dexamethasone', 'lignocaine with 1:200,000 adrenaline and sub-group TM received twin mix']","['anesthetic latency', 'longer latency of anesthesia', 'VAS scores', 'swelling, post-surgical pain and trismus postoperatively', 'Mean (±SD', 'duration of soft tissue anesthesia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}]",,0.0542578,VAS scores for sting on injection and pain were found to be less in TM and MTM sub-group with a score of 2.3 (±0.768) and 2.7 (±0.065) respectively.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Beena', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, People's College of Dental Sciences and Research Center, People's University, H-3/2, B.D.A Colony, Nayapura, Lal Ghati, Airport Road, 462037 Bhanpur, Bhopal, MP, India.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bhargava', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, People's College of Dental Sciences and Research Center, People's University, H-3/2, B.D.A Colony, Nayapura, Lal Ghati, Airport Road, 462037 Bhanpur, Bhopal, MP, India. Electronic address: emaildarpan@gmail.com.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gurjar', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, People's College of Dental Sciences and Research Center, People's University, H-3/2, B.D.A Colony, Nayapura, Lal Ghati, Airport Road, 462037 Bhanpur, Bhopal, MP, India.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shrivastava', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, People's College of Dental Sciences and Research Center, People's University, H-3/2, B.D.A Colony, Nayapura, Lal Ghati, Airport Road, 462037 Bhanpur, Bhopal, MP, India.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Dalsingh', 'Affiliation': 'Head, Department of Oral and Maxillofacial Surgery, Lenora Institute of Dental Sciences, 533294 Rajahmundry, AP, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Koneru', 'Affiliation': 'Sibar Institute of Dental Sciences and Research Center, Department of Oral and Maxillofacial Surgery, 522509 Vijayawada, AP, India.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2019.07.011']
575,31330502,Effects of Suspension Versus Traditional Resistance Training on Explosive Strength in Elementary School-Aged Boys.,"PURPOSE


The aim of this study was to determine the effects of an 8-week program of resistance training (RT) or suspension training (ST) on explosive strength in prepubescent boys.
METHODS


Fifty-seven boys aged 10-11 years were assigned to 2 training groups, RT or ST or a control group (no training program). Boys trained twice weekly for 8 weeks.
RESULTS


A significant interaction was reported with a large (P < .001, ηp2=.463), medium (P < .001, ηp2=.395), and small effect sized (P ≤ .001, ηp2=.218) in the 1-kg ball throw, 3-kg ball throw, and time-at-20-m test, respectively. There was no significant interaction in the countermovement vertical jump or the standing long jump. Changes from preintervention to postintervention for the 1-kg ball throw were 5.94% and 5.82% for the ST and RT, respectively, and 8.82% and 8.14% in the 3-kg ball throw for the ST and RT, respectively. The improvement in the 20-m sprint was 1.19% for the ST and 2.33% for the RT.
CONCLUSION


Traditional RT and ST seem to be effective methods for improving explosive strength in prepubescent boys. ST could be considered as an alternative modality to optimize explosive strength training in school-based programs.",2019,There was no significant interaction in the countermovement vertical jump or the standing long jump.,"['prepubescent boys', 'Fifty-seven boys aged 10-11 years', 'Elementary School-Aged Boys']","['Suspension Versus Traditional Resistance Training', 'resistance training (RT) or suspension training (ST', 'RT or ST or a control group (no training program']","['Explosive Strength', 'countermovement vertical jump or the standing long jump', 'explosive strength', '20-m sprint']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1721090', 'cui_str': 'Explosives'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",,0.0167912,There was no significant interaction in the countermovement vertical jump or the standing long jump.,"[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Marta', 'Affiliation': 'Polytechnic Institute of Guarda.'}, {'ForeName': 'Ana R', 'Initials': 'AR', 'LastName': 'Alves', 'Affiliation': 'Polytechnic Institute of Beja.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Esteves', 'Affiliation': 'Polytechnic Institute of Guarda.'}, {'ForeName': 'Natalina', 'Initials': 'N', 'LastName': 'Casanova', 'Affiliation': 'Polytechnic Institute of Guarda.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Marinho', 'Affiliation': 'Research Centre in Sports Sciences, Health Sciences and Human Development.'}, {'ForeName': 'Henrique P', 'Initials': 'HP', 'LastName': 'Neiva', 'Affiliation': 'Research Centre in Sports Sciences, Health Sciences and Human Development.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Aguado-Jimenez', 'Affiliation': 'Public University of Navarre.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Alonso-Martínez', 'Affiliation': 'Public University of Navarre.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Public University of Navarre.'}, {'ForeName': 'Mário C', 'Initials': 'MC', 'LastName': 'Marques', 'Affiliation': 'Research Centre in Sports Sciences, Health Sciences and Human Development.'}]",Pediatric exercise science,['10.1123/pes.2018-0287']
576,31329961,A Brief Mindfulness Intervention for Medically Hospitalized Patients with Acute Pain: A Pilot Randomized Clinical Trial.,"OBJECTIVE


Mindfulness interventions may be beneficial for patients with chronic pain; however, the effects for acute pain are not understood. The purpose of this study was to pilot test a brief mindfulness intervention for acute pain and stress for patients in an inpatient medical setting.
DESIGN


Pilot randomized clinical trial.
SETTING


An inpatient Acute Care Surgery service at an urban hospital.
SUBJECTS


Sixty patients with acute pain were randomly selected and agreed to participate.
METHODS


Interested patients consented to the study and were randomized to the 10-minute intervention (i.e., mindfulness strategy) or comparison group (i.e., education on the Gate Control Theory of Pain). Participants completed pre- and post-assessment measures on pain severity and stress.
RESULTS


Preliminary results showed that within the intervention and comparison groups, participants experienced decreases in pain from pre- to post-intervention (P = 0.002 and 0.005, respectively). Within the intervention group, there was a significant decrease in stress from pre- to post-intervention (P = 0.001). There were no significant changes for stress within the comparison group (P = 0.32). There were no significant differences between the intervention and comparison groups for pain (P = 0.44) or stress (P = 0.07) at post-intervention, although Cohen's d effect sizes were small to medium for pain and stress, respectively.
CONCLUSIONS


A brief mindfulness intervention for medically hospitalized patients with acute pain may decrease pain and stress. Future research should examine this intervention with a fully powered, larger sample to examine efficacy.",2019,"There were no significant differences between the intervention and comparison groups for pain (P = 0.44) or stress (P = 0.07) at post-intervention, although Cohen's d effect sizes were small to medium for pain and stress, respectively.
","['An inpatient Acute Care Surgery service at an urban hospital', 'medically hospitalized patients with acute pain', 'Medically Hospitalized Patients with Acute Pain', 'acute pain and stress for patients in an inpatient medical setting', 'Interested patients consented to the study', 'patients with chronic pain', 'Sixty patients with acute pain were randomly selected and agreed to participate']","['mindfulness strategy) or comparison group (i.e., education on the Gate Control Theory of Pain', 'Mindfulness Intervention', 'mindfulness intervention']","['pain severity and stress', 'stress', 'pain and stress', 'pain']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",60.0,0.0489992,"There were no significant differences between the intervention and comparison groups for pain (P = 0.44) or stress (P = 0.07) at post-intervention, although Cohen's d effect sizes were small to medium for pain and stress, respectively.
","[{'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Miller-Matero', 'Affiliation': 'Behavioral Health Department.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Coleman', 'Affiliation': 'Behavioral Health Department.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Smith-Mason', 'Affiliation': 'Behavioral Health Department.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Moore', 'Affiliation': 'Behavioral Health Department.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Marszalek', 'Affiliation': 'Behavioral Health Department.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Ahmedani', 'Affiliation': 'Behavioral Health Department.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz082']
577,32491941,Effect of computer-assisted-learning and simulation clinics on dental students' cognitive and performance skills: panoramic image errors related to patient's head position.,"OBJECTIVES


To assess dental students' ability to recognize head positioning errors in panoramic (PAN) images after individual learning via computer-assisted-learning (CAL) and in a simulation clinic (SIM). Both cognitive skills and performance in patient examination were assessed.
METHODS AND MATERIALS


60 students (mean age 23.25 years) participated in lectures on the relation between PAN-image errors and patient's head position. Immediately after they took a test, based on which they were randomized to three groups: control (CON) group, CAL group, and SIM group (both CAL and training in a simulation clinic with a phantom). 4-5 weeks after intervention/no intervention, all students individually examined a patient with PAN-exposure. A blinded rater, not knowing group allocation, supervised patient exposure and assessed student's performance (correct/incorrect head position in three planes). 1-2 weeks after, the students scored positioning errors in 40 PAN-images. Differences in cognitive test scores between groups were evaluated by ANOVA and in patient examination by χ 2  tests, and within-group differences by sign-tests.
RESULTS


No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p  < 0.003). In all groups, several students positioned the patient incorrectly in the Frankfort horizontal plane. All students performed well in the sagittal plane. Students in SIM group positioned the patient more correctly in the coronal plane.
CONCLUSIONS


Training with CAL increased students' cognitive skills compared with a control group. Simulated patient exposure with a phantom increased to some extent their performance skills in examination of patients.",2020,"No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p  < 0.003).","[""dental students' cognitive and performance skills"", ""Sixty students (mean age 23.25 years) participated in lectures on the relation between PAN-image errors and patient's head position""]","['control (CON)group, CAL group, and SIM group (both CAL and training in a simulation clinic with a phantom', 'individual learning via computer-assisted-learning (CAL', 'computer-assisted-learning and simulation clinics', 'CON', 'Training with computer-assisted-learning']","[""students' cognitive skills"", 'cognitive test scores']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582540', 'cui_str': 'Head position finding'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0253438,"No statistically significant difference in cognitive test scores was seen between the SIM and CAL group, while the CON group scored lower ( p  < 0.003).","[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Wenzel', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Louise Hauge', 'Initials': 'LH', 'LastName': 'Matzen', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Spin-Neto', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schropp', 'Affiliation': 'Section for Oral Radiology, Department of Dentistry and Oral Health, Health Faculty, Aarhus University, Aarhus, Denmark.'}]",Dento maxillo facial radiology,['10.1259/dmfr.20200154']
578,31303261,Strengthened Hippocampal Circuits Underlie Enhanced Retrieval of Extinguished Fear Memories Following Mindfulness Training.,"BACKGROUND


The role of hippocampus in context-dependent recall of extinction is well recognized. However, little is known about how intervention-induced changes in hippocampal networks relate to improvements in extinction learning. In this study, we hypothesized that mindfulness training creates an optimal exposure condition by heightening attention and awareness of present moment sensory experience, leading to enhanced extinction learning, improved emotion regulation, and reduced anxiety symptoms.
METHODS


We tested this hypothesis in a randomized controlled longitudinal study design using a 2-day fear conditioning and extinction protocol. The mindfulness training group included 42 participants (28 women) and the control group included 25 participants (15 women).
RESULTS


We show that mindfulness training is associated with differential engagement of the right supramarginal gyrus as well as hippocampal-cortical reorganization. We also report enhanced hippocampal connectivity to the primary sensory cortex during retrieval of extinguished stimuli following mindfulness training.
CONCLUSIONS


These findings suggest hippocampal-dependent changes in contextual retrieval as one plausible neural mechanism through which mindfulness-based interventions enhance fear extinction and foster stress resilience.",2019,We show that mindfulness training is associated with differential engagement of the right supramarginal gyrus as well as hippocampal-cortical reorganization.,['group included 42 participants (28 women) and the control group included 25 participants (15 women'],"['2-day fear conditioning and extinction protocol', 'mindfulness training']","['enhanced extinction learning, improved emotion regulation, and reduced anxiety symptoms']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",42.0,0.0226357,We show that mindfulness training is associated with differential engagement of the right supramarginal gyrus as well as hippocampal-cortical reorganization.,"[{'ForeName': 'Gunes', 'Initials': 'G', 'LastName': 'Sevinc', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: gsevinc@mgh.harvard.edu.'}, {'ForeName': 'Britta K', 'Initials': 'BK', 'LastName': 'Hölzel', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Department of Neuroradiology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Gard', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Brunsch', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Javeria A', 'Initials': 'JA', 'LastName': 'Hashmi', 'Affiliation': 'Department of Anesthesia, Pain Management & Perioperative Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Vangel', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Orr', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Mohammed R', 'Initials': 'MR', 'LastName': 'Milad', 'Affiliation': 'Psychiatry Department, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Sara W', 'Initials': 'SW', 'LastName': 'Lazar', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.05.017']
579,31053468,Component Placement in Direct Lateral vs Minimally Invasive Anterior Approach in Total Hip Arthroplasty: Radiographic Outcomes From a Prospective Randomized Controlled Trial.,"BACKGROUND


End-stage coxarthrosis is increasingly common; however, limited evidence exists on the effect of direct lateral approach (DLA) and minimally invasive direct anterior approach (MIDA) on component placement in total hip arthroplasty (THA). We therefore conducted a prospective, randomized controlled trial to determine the component placement in DLA vs MIDA in THA.
METHODS


Between January 2012 and June 2013, 164 patients with clinically and radiologically confirmed coxarthrosis aged 20-80 years were randomized to either DLA or MIDA (active comparator). Excluded were patients with previous ipsilateral hip surgery, a body mass index >35 kg/m 2 , and/or mental disability. Primary clinical outcomes have been published elsewhere. Secondary outcomes included radiographic assessment of the acetabular component (cement-mantle thickness, inclination, and anteversion), femoral stem position (varus/valgus and THA index), offset restoration, and leg length discrepancy.
RESULTS


The mean cement-mantle was significantly thicker in zone 1 in the MIDA group (mean difference = 0.51 mm, 95% confidence interval [CI] 0.09-0.93, P = .018), and the mean degrees of inclination and anteversion were higher in the MIDA group (mean difference = 2.5°, 95% CI 0.3-4.6, P = .023 and mean difference = 3.6°, 95% CI 2.2-5.0, P < .0001, respectively). According to the defined reference range, cup inclination was more often adequate in the DLA group (67.9% (53/78) in the DLA group vs 52.4% (43/82) in the MIDA group, P = .045). There were no differences in frontal or lateral femoral stem position, global offset restoration, or leg length discrepancy.
CONCLUSION


In this population of Norwegian patients with coxarthrosis, radiographic assessment showed limited differences in component placement between MIDA and DLA. The findings suggest that component placement is similar in the 2 surgical approaches.",2019,"The mean cement-mantle was significantly thicker in zone 1 in the MIDA group (mean difference = 0.51 mm, 95% confidence interval [CI] 0.09-0.93, P = .018), and the mean degrees of inclination and anteversion were higher in the MIDA group (mean difference =","['Between January 2012 and June 2013, 164 patients with clinically and radiologically confirmed coxarthrosis aged 20-80 years', 'Total Hip Arthroplasty', 'total hip arthroplasty (THA', 'Excluded were patients with previous ipsilateral hip surgery, a body mass index >35 kg/m 2 , and/or mental disability']","['Component Placement in Direct Lateral vs Minimally Invasive Anterior Approach', 'DLA or MIDA (active comparator', 'direct lateral approach (DLA) and minimally invasive direct anterior approach (MIDA']","['radiographic assessment of the acetabular component (cement-mantle thickness, inclination, and anteversion), femoral stem position (varus/valgus and THA index), offset restoration, and leg length discrepancy', 'mean cement-mantle', 'mean degrees of inclination and anteversion', 'frontal or lateral femoral stem position, global offset restoration, or leg length discrepancy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0029410', 'cui_str': 'Coxarthrosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1306341', 'cui_str': 'Mental handicap (finding)'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach (qualifier value)'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0333053', 'cui_str': 'Anteversion (morphologic abnormality)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0443345', 'cui_str': 'Varus (qualifier value)'}, {'cui': 'C0443344', 'cui_str': 'Valgus (qualifier value)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0426952', 'cui_str': 'Leg length (observable entity)'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",164.0,0.164628,"The mean cement-mantle was significantly thicker in zone 1 in the MIDA group (mean difference = 0.51 mm, 95% confidence interval [CI] 0.09-0.93, P = .018), and the mean degrees of inclination and anteversion were higher in the MIDA group (mean difference =","[{'ForeName': 'Ole-Christian L', 'Initials': 'OL', 'LastName': 'Brun', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ulleval, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Helge N', 'Initials': 'HN', 'LastName': 'Sund', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ulleval, Oslo, Norway; Sorlandet Hospital HF, Arendal, Kristiansand, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nordsletten', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ulleval, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Röhrl', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital Ulleval, Oslo, Norway.'}, {'ForeName': 'Knut E', 'Initials': 'KE', 'LastName': 'Mjaaland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Sorlandet Hospital HF, Arendal, Kristiansand, Norway.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.04.003']
580,31323643,"Effects of Simulated Horseback Riding on Balance, Postural Sway, and Quality of Life in Older Adults With Parkinson's Disease.","The purpose of this study was to determine changes in balance, postural sway, and quality of life after 6 wk of simulated horseback riding in adults diagnosed with Parkinson's disease. Eight older adults completed two 60-min riding sessions weekly for 6 wk. Variables of balance, postural sway, and quality of life were measured 6 wks before and within 1 wk before and after the intervention. Berg Balance Scale scores decreased from baseline to preintervention (48.36 ± 5.97 vs. 45.86 ± 6.42, p = .050) and increased from preintervention to postintervention (45.86 ± 6.42 vs. 50.00 ± 4.38, p = .002). Cognitive impairment, a dimension of quality of life, improved from baseline to postintervention (37.5 ± 20.5 vs. 21.5 ± 14.4, p = .007). Six weeks of simulated horseback riding may improve balance and cognitive impairment in older adults with Parkinson's disease.",2019,"Berg Balance Scale scores decreased from baseline to preintervention (48.36 ± 5.97 vs. 45.86 ± 6.42, p = .050) and increased from preintervention to postintervention (45.86 ± 6.42 vs. 50.00 ± 4.38, p = .002).","[""older adults with Parkinson's disease"", ""adults diagnosed with Parkinson's disease"", ""Older Adults With Parkinson's Disease"", 'Eight older adults']","['Simulated Horseback Riding', 'simulated horseback riding']","['balance and cognitive impairment', 'Berg Balance Scale scores', 'Cognitive impairment, a dimension of quality of life', 'Balance, Postural Sway, and Quality of Life', 'Variables of balance, postural sway, and quality of life', 'balance, postural sway, and quality of life']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]",[],"[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",8.0,0.0392512,"Berg Balance Scale scores decreased from baseline to preintervention (48.36 ± 5.97 vs. 45.86 ± 6.42, p = .050) and increased from preintervention to postintervention (45.86 ± 6.42 vs. 50.00 ± 4.38, p = .002).","[{'ForeName': 'Leah S', 'Initials': 'LS', 'LastName': 'Goudy', 'Affiliation': ""Texas Woman's University.""}, {'ForeName': 'Brandon Rhett', 'Initials': 'BR', 'LastName': 'Rigby', 'Affiliation': ""Texas Woman's University.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Silliman-French', 'Affiliation': ""Texas Woman's University.""}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Becker', 'Affiliation': ""Texas Woman's University.""}]",Adapted physical activity quarterly : APAQ,['10.1123/apaq.2019-0008']
581,32125188,"Leptin levels are not affected by enalapril treatment after an uncomplicated myocardial infarction, but associate strongly with changes in fibrinolytic variables in men.","Leptin, an adipocyte-derived hormone, is involved in the regulation of body weight and is associated with obesity-related complications, notably cardiovascular disease (CVD). A putative link between obesity and CVD could be induction of plasminogen activator inhibitor-1 (PAI-1) synthesis by leptin. In this study, we hypothesized that the beneficial effect of the angiotensin-converting enzyme inhibitor (ACE i ) enalapril on PAI-1 levels is mediated by effects on leptin levels. The association between leptin and components of the fibrinolytic system was evaluated in a non-prespecified  post hoc  analysis of a placebo-controlled randomized, double-blind trial where the effect of the ACE i  enalapril on fibrinolysis was tested. A total of 46 men and 37 women were randomized to treatment with enalapril or placebo after (median 12 months) an uncomplicated myocardial infarction. At baseline, the participants were stable and had no signs of congestive heart failure. Leptin and fibrinolytic variables (mass concentrations of PAI-1, tissue plasminogen activator (tPA) and tPA-PAI complex) were measured at baseline, and after 10 days, 6 months and 12 months. Enalapril treatment did not change leptin levels, which increased significantly during 1 year of follow-up ( p  = .007). Changes in leptin levels were strongly associated with changes of tPA mass ( p  = .001), tPA-PAI complex ( p  = .003) and of PAI-1 ( p  = .006) in men, but not in women. Leptin levels are not influenced by treatment with an ACE i . In contrast, leptin associates strongly with changes in fibrinolytic variables notably with a sex difference, which could be of importance for obesity-related CVD.",2020,"Leptin and fibrinolytic variables (mass concentrations of PAI-1, tissue plasminogen activator (tPA) and tPA-PAI complex) were measured at baseline, and after 10 days, 6 months and 12 months.",['A total of 46 men and 37 women'],"['enalapril or placebo', 'enalapril', 'ACE i  enalapril', 'Enalapril', 'angiotensin-converting enzyme inhibitor (ACE i ) enalapril']","['change leptin levels', 'Leptin levels', 'tPA mass', 'tPA-PAI complex', 'Leptin and fibrinolytic variables (mass concentrations of PAI-1, tissue plasminogen activator (tPA) and tPA-PAI complex', 'leptin levels', 'congestive heart failure', 'fibrinolytic variables']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0522326', 'cui_str': 'tPA-PAI complex'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0560150', 'cui_str': 'Unit of mass concentration'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}]",46.0,0.21255,"Leptin and fibrinolytic variables (mass concentrations of PAI-1, tissue plasminogen activator (tPA) and tPA-PAI complex) were measured at baseline, and after 10 days, 6 months and 12 months.","[{'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Eriksson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Medicine, Umeå University, Umea, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Söderberg', 'Affiliation': 'Department of Public Health and Clinical Medicine, Medicine, Umeå University, Umea, Sweden.'}, {'ForeName': 'Torbjörn K', 'Initials': 'TK', 'LastName': 'Nilsson', 'Affiliation': 'Department of Medical Biosciences/Clinical Chemistry, Umeå University, Umea, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'Department of Statistics, USBE, Umeå University, Umea, Sweden.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Boman', 'Affiliation': 'Research Unit Skellefteå, Department of Public Health and Clinical Medicine, Umeå University, Umea, Sweden.'}, {'ForeName': 'Jan-Håkan', 'Initials': 'JH', 'LastName': 'Jansson', 'Affiliation': 'Research Unit Skellefteå, Department of Public Health and Clinical Medicine, Umeå University, Umea, Sweden.'}]",Scandinavian journal of clinical and laboratory investigation,['10.1080/00365513.2020.1731848']
582,32058361,Aerobic Exercise Performance During Load Carriage and Acute Altitude Exposure.,"Coffman, KE, Luippold, AJ, Salgado, RM, Heavens, KR, Caruso, EM, Fulco, CS, and Kenefick, RW. Aerobic exercise performance during load carriage and acute altitude exposure. J Strength Cond Res 34(4): 946-951, 2020-This study quantified the impact of combined load carriage and acute altitude exposure on 5-km running time-trial (TT) performance and self-selected pacing strategy. Furthermore, this study developed a velocity prediction tool (nomogram) for similar aerobic exercise tasks performed under various combinations of altitude and load stress. Nine volunteers (6M/3F, age: 24 ± 7 years, height: 171 ± 6 cm, body mass: 72 ± 7 kg, and V[Combining Dot Above]O2peak: 50.5 ± 5.2 ml·min·kg) completed a randomized, repeated-measures design protocol. Volunteers performed 3 familiarization (FAM) trials at sea level (SL; 250 m) with no-load carriage. Experimental testing included 3 self-paced, blinded 5-km running TT on a treadmill while carrying a 30% body mass external load at SL, moderate altitude (MA; 2000 m), and high altitude (HA; 3000 m). At SL, load carriage resulted in a 36% decrement in 5-km exercise performance in comparison with FAM trials (43 ± 7 vs. 32 ± 3 minutes; p < 0.001). Time required to complete the 5-km distance while carrying an external load was increased by 11% when performed at HA vs. SL (48 ± 7 vs. 43 ± 7 minutes; p = 0.001). TT pace was not different among experimental conditions (load carriage at SL, MA, and HA) until after 1 km of the running distance had been completed. Heart rate was not different among experimental conditions throughout the entire TT (170 ± 17 b·min). These data quantify the anticipated reduction in aerobic exercise performance under various combinations of acute altitude exposure and load carriage conditions. The self-paced running TT approach used presently allowed for development of an altitude-load nomogram for use in recreational, occupational, or military settings.",2020,"At SL, load carriage resulted in a 36% decrement in 5-km exercise performance in comparison with FAM trials (43 ± 7 vs. 32 ± 3 minutes; p < 0.001).","['Nine volunteers (6M/3F, age: 24 ± 7 years, height: 171 ± 6 cm, body mass: 72 ± 7 kg, and V[Combining']",['J Strength Cond Res XX(X'],"['Time required to complete the 5-km distance while carrying an external load', 'Coffman, KE, Luippold, AJ, Salgado, RM, Heavens, KR, Caruso, EM, Fulco, CS, and Kenefick, RW', 'Heart rate', 'Aerobic Exercise Performance', '5-km running time-trial (TT) performance and self-selected pacing strategy', 'aerobic exercise performance', '5-km exercise performance', 'Aerobic exercise performance']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",9.0,0.10286,"At SL, load carriage resulted in a 36% decrement in 5-km exercise performance in comparison with FAM trials (43 ± 7 vs. 32 ± 3 minutes; p < 0.001).","[{'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Coffman', 'Affiliation': 'Thermal and Mountain Medicine Division, U.S. Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Luippold', 'Affiliation': ''}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Salgado', 'Affiliation': ''}, {'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Heavens', 'Affiliation': ''}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Caruso', 'Affiliation': ''}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fulco', 'Affiliation': ''}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Kenefick', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003557']
583,31913252,"Effect of Acute Beetroot Juice Supplementation on Bench Press Power, Velocity, and Repetition Volume.","Williams, TD, Martin, MP, Mintz, JA, Rogers, RR, and Ballmann, CG. Effect of acute beetroot juice supplementation on bench press power, velocity, and repetition volume. J Strength Cond Res 34(4): 924-928, 2020-The purpose of this study was to examine the effects of acute beetroot juice (BRJ) supplementation on power, velocity, and repetitions to failure (RTF) during bench press exercise. Resistance-trained male subjects (n = 11) were recruited for this study. Using a double-blinded, counterbalanced, crossover study design, subjects were supplemented with either 70 ml of BRJ or placebo (PL; black currant juice) 2 hours before exercise. During each exercise trial, subjects began by completing 2 sets × 2 repetitions of bench press at 70% 1 repetition maximum (1RM) with maximum explosive intent. Barbell velocity and power were measured using a linear position transducer. Subjects then completed 3 sets × RTF at 70% 1RM separated by 2 minutes of rest between each set. Maximum mean power, velocity, and repetitions were analyzed. Mean velocity (p = 0.011; effect size [ES] = 0.54) and mean power (p = 0.015; ES = 0.51) were significantly higher with BRJ when compared with PL. Total RTF (p = 0.002; ES = 0.46) was higher during the BRJ condition vs. PL. Results indicate that acute BRJ supplementation positively impacts velocity, power, and total repetitions during free-weight bench press exercise.",2020,Total RTF (p = 0.002; ES = 0.46) was higher during the BRJ condition vs. PL.,['Resistance-trained male subjects (n = 11'],"['J Strength Cond Res XX(X', 'acute beetroot juice (BRJ) supplementation', 'BRJ or placebo', 'Acute Beetroot Juice Supplementation', 'acute beetroot juice supplementation']","['Total RTF', 'Mean velocity', 'impacts velocity, power, and total repetitions during free-weight bench press exercise', 'power, velocity, and repetitions to failure (RTF', 'Bench Press Power, Velocity, and Repetition Volume', 'bench press power, velocity, and repetition volume', 'Maximum mean power, velocity, and repetitions', 'Williams, TD, Martin, MP, Mintz, JA, Rogers, RR, and Ballmann, CG']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.169736,Total RTF (p = 0.002; ES = 0.46) was higher during the BRJ condition vs. PL.,"[{'ForeName': 'Tyler D', 'Initials': 'TD', 'LastName': 'Williams', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Jake A', 'Initials': 'JA', 'LastName': 'Mintz', 'Affiliation': ''}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Rogers', 'Affiliation': ''}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Ballmann', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003509']
584,31913254,Effect of Multi-Ingredient Preworkout Supplementation on Repeated Sprint Performance in Recreationally Active Men and Women.,"Gonzalez, AM, Pinzone, AG, Bram, J, Salisbury, JL, Lee, S, and Mangine, GT. Effect of multi-ingredient preworkout supplementation on repeated sprint performance in recreationally active men and women. J Strength Cond Res 34(4): 918-923, 2020-The purpose of this investigation was to examine the effects of acute supplementation of a multi-ingredient preworkout supplement (MIPS), containing a proprietary blend of ancient peat and apple extracts, creatine monohydrate, taurine, ribose, and magnesium, on sprint cycling performance. Seventeen recreationally active men and women (23.2 ± 5.9 years; 172.9 ± 14.3 cm; 82.4 ± 14.5 kg) underwent 2 testing sessions administered in a randomized, counterbalanced, double-blind fashion. Subjects were provided either MIPS or placebo (PL) one hour before performing a sprint cycling protocol, which consisted of ten 5-second ""all-out"" sprints interspersed by 55 seconds of unloaded pedaling. Average power (PAVG), peak power (PPK), average velocity (VAVG), and distance covered were recorded for each sprint. Separate linear mixed models revealed decrements (p < 0.05) compared to the first sprint in PAVG (75-229 W) and PPK (79-209 W) throughout all consecutive sprints after the initial sprint during PL. Likewise, diminished (p ≤ 0.029) VAVG (3.37-6.36 m·s) and distance covered (7.77-9.00 m) were noted after the third and fifth sprints, respectively, during PL. By contrast, during MIPS, only VAVG decreased (2.34-5.87 m·s, p ≤ 0.002) on consecutive sprints after the first sprint, whereas PAVG and PPK were maintained. In addition, a significant decrease (p = 0.045) in distance covered was only observed on the ninth sprint during MIPS. These data suggest that recreational athletes who consumed the MIPS formulation, one hour before a repeated sprinting session on a cycle ergometer, better maintained performance compared with PL.",2020,Separate linear mixed models revealed decrements (p < 0.05) compared to the first sprint in PAVG (75-229 W) and PPK (79-209 W) throughout all consecutive sprints after the initial sprint during PL.,"['Seventeen recreationally active men and women (23.2 ± 5.9 years; 172.9 ± 14.3 cm; 82.4 ± 14.5 kg', 'Recreationally Active Men and Women', 'recreationally active men and women']","['J Strength Cond Res XX(X', 'Multi-Ingredient Preworkout Supplementation', 'MIPS or placebo (PL) one hour before performing a sprint cycling protocol, which consisted of ten 5-second ""all-out"" sprints interspersed by 55 seconds of unloaded pedaling', 'multi-ingredient preworkout supplementation', 'multi-ingredient preworkout supplement (MIPS), containing a proprietary blend of ancient peat and apple extracts, creatine monohydrate, taurine, ribose, and magnesium']","['Average power (PAVG), peak power (PPK), average velocity (VAVG), and distance covered', 'VAVG', 'Repeated Sprint Performance', 'repeated sprint performance']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0030739', 'cui_str': 'Peat'}, {'cui': 'C3257517', 'cui_str': 'Apple extract'}, {'cui': 'C0873188', 'cui_str': 'Creatine Monohydrate'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0035549', 'cui_str': 'Ribose'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]",229.0,0.146449,Separate linear mixed models revealed decrements (p < 0.05) compared to the first sprint in PAVG (75-229 W) and PPK (79-209 W) throughout all consecutive sprints after the initial sprint during PL.,"[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Health Professions, Hofstra University, Hempstead, New York.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Pinzone', 'Affiliation': 'Department of Health Professions, Hofstra University, Hempstead, New York.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bram', 'Affiliation': 'Department of Health Professions, Hofstra University, Hempstead, New York.'}, {'ForeName': 'Jillian L', 'Initials': 'JL', 'LastName': 'Salisbury', 'Affiliation': 'Department of Health Professions, Hofstra University, Hempstead, New York.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Health Professions, Hofstra University, Hempstead, New York.'}, {'ForeName': 'Gerald T', 'Initials': 'GT', 'LastName': 'Mangine', 'Affiliation': 'Department of Exercise Science and Sport Management, Kennesaw State University, Kennesaw, Georgia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003480']
585,32028090,In-kind incentives and health worker performance: Experimental evidence from El Salvador.,"We experimentally evaluated the effects of in-kind team incentives on health worker performance in El Salvador, with 38 out of 75 community health teams randomly assigned to performance incentives over a 12-month period. All teams received monitoring, performance feedback and recognition for their achievements allowing us to isolate the effect of the incentive. While both treatment and control groups exhibit improvements in performance measures over time, the in-kind incentives generated significant improvements in community outreach, quality of care, timeliness of care, and utilization of maternal and child health services after 12 months. Gains were largest for teams at the bottom and top of the baseline performance distribution. We find no evidence of results being driven by changes in reporting or by shifting away effort from non-contracted outcomes. These results suggest that in-kind team incentives may be a viable alternative to monetary or individual incentives in certain contexts.",2020,"While both treatment and control groups exhibit improvements in performance measures over time, the in-kind incentives generated significant improvements in community outreach, quality of care, timeliness of care, and utilization of maternal and child health services after 12 months.","['El Salvador, with 38 out of 75 community health teams']",[],"['community outreach, quality of care, timeliness of care, and utilization of maternal and child health services', 'health worker performance']","[{'cui': 'C0013754', 'cui_str': 'El Salvador'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]",[],"[{'cui': 'C0282110', 'cui_str': 'Community Outreach'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008079', 'cui_str': 'Child Health Services'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",75.0,0.0663259,"While both treatment and control groups exhibit improvements in performance measures over time, the in-kind incentives generated significant improvements in community outreach, quality of care, timeliness of care, and utilization of maternal and child health services after 12 months.","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Bernal', 'Affiliation': 'Inter-American Development Bank, 1300 New York Avenue, NW, Washington, DC, 20577, United States. Electronic address: pbernallara@iadb.org.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Inter-American Development Bank, 1300 New York Avenue, NW, Washington, DC, 20577, United States. Electronic address: smartinez@iadb.org.'}]",Journal of health economics,['10.1016/j.jhealeco.2019.102267']
586,31996613,Real and Perceived Effects of Caffeine on Sprint Cycling in Experienced Cyclists.,"Anderson, DE, German, RE, Harrison, ME, Bourassa, KN, and Taylor, CE. Real and perceived effects of caffeine on sprint cycling in experienced cyclists. J Strength Cond Res 34(4): 929-933, 2020-Caffeine ingestion before an exercise bout may provide ergogenic effects on anaerobic performance, particularly in trained athletes. However, the degree of influence of caffeine may be coupled with the placebo effect. A double-blind, placebo-controlled, randomized design was used to determine the real and perceived effects of caffeine on anaerobic performance. Ten competitively trained cyclists (9 men and 1 woman) completed 3 trials of the Wingate Anaerobic Test (WAnT). Subjects were given coffee that they believed contained a high caffeine dose, a low caffeine dose, or a placebo 45 minutes before WAnT. Subjects were actually given 2 placebos (decaffeinated coffee) and one dose of caffeine (280 mg). Level of significance was p ≤ 0.05. No significant differences were found between trials for blood lactate concentration and heart rate. Seven of the subjects (70%) correctly identified the caffeine trial as the high caffeine trial. Time to peak power was significantly shorter for the trial in which subjects incorrectly guessed they had consumed caffeine when given the placebo compared with placebo trial (1.6 ± 0.1 vs. 2.3 ± 0.2 seconds). Power drop was significantly higher for the trial in which subjects incorrectly guessed they had consumed caffeine when given the placebo compared with placebo trial (524 ± 37 vs. 433 ± 35 W). There seems to be a placebo effect of caffeine on anaerobic performance. Improved performance may result from psychological advantages rather than physical advantages. Coaches may find it beneficial to use a placebo to improve anaerobic performance, especially if concerned about the side effects or cost of caffeine.",2020,Power drop was significantly higher for the trial in which subjects incorrectly guessed they had consumed caffeine when given the placebo compared with placebo trial (524 ± 37 vs. 433 ± 35 W).,"['Ten competitively trained cyclists (9 men and 1 woman) completed 3 trials of the Wingate Anaerobic Test (WAnT', 'experienced cyclists', 'Experienced Cyclists']","['placebos (decaffeinated coffee) and one dose of caffeine', 'caffeine', 'Caffeine', 'J Strength Cond Res XX(X', 'placebo']","['anaerobic performance', 'blood lactate concentration and heart rate', 'Time to peak power']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",10.0,0.436002,Power drop was significantly higher for the trial in which subjects incorrectly guessed they had consumed caffeine when given the placebo compared with placebo trial (524 ± 37 vs. 433 ± 35 W).,"[{'ForeName': 'Dawn E', 'Initials': 'DE', 'LastName': 'Anderson', 'Affiliation': 'Kinesiology Department, Taylor University, Upland, Indiana.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'German', 'Affiliation': ''}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Harrison', 'Affiliation': ''}, {'ForeName': 'Keely N', 'Initials': 'KN', 'LastName': 'Bourassa', 'Affiliation': ''}, {'ForeName': 'Cara E', 'Initials': 'CE', 'LastName': 'Taylor', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003537']
587,31841156,Exploring Patients' Experiences of Internet-Based Self-Management Support for Low Back Pain in Primary Care.,"OBJECTIVE


We explored patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance.
DESIGN


Exploratory descriptive qualitative study using thematic analysis, nested within a randomized feasibility trial.
METHODS


Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population). Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population). Data were analyzed thematically.
RESULTS


Analysis resulted in the development of six themes (subthemes in parentheses): Perceptions of SupportBack's design (Clarity and ease of use, Variety and range of information provided, Need for specificity and flexibility), Engaging with the SupportBack intervention, Promoting positive thought processes (Reassurance, Awareness of self-management), Managing behavior with SupportBack (Motivation and goal setting, Using activity as a pain management strategy, Preferences for walking or gentle back exercises), Feeling supported by telephone physiotherapists (Provision of reassurances and clarity, Physiotherapists are motivating), Severity and comorbidity as barriers (Preexisting condition or severity acting as a barrier, Less useful for mild low back pain).
CONCLUSIONS


The Internet intervention SupportBack appeared to feasibly support self-management of LBP. Reassurance and ongoing support to implement behavioral changes were central to reported benefits. The addition of physiotherapist telephone support further enhanced the patient experience and the potential utility of the intervention.",2020,The Internet intervention SupportBack appeared to feasibly support self-management of LBP.,"[""patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance"", 'Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population', 'Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population', 'for Low Back Pain in Primary Care']","['Internet-Based Self-Management Support', 'physiotherapist telephone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]",[],15.0,0.0816618,The Internet intervention SupportBack appeared to feasibly support self-management of LBP.,"[{'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Roberts', 'Affiliation': 'School of Health Sciences, University of Southampton & University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Stanford', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Yoganantham', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Hay', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz312']
588,31291164,"Effects of White Potatoes Consumed With Eggs on Satiety, Food Intake, and Glycemic Response in Children and Adolescents.","Objective:  Short-term studies in adults have shown that white potatoes increase satiety and suppress food intake (FI) compared with several other carbohydrate-containing foods; however, studies are limited in children. The objective was to compare the effects of white potatoes in mixed meals on satiety, FI, and glycemic response in 9-14-year-old children and adolescents. Methods:  Using a within-subject, repeated-measures design, 21 children completed five counter-balanced test sessions. After an overnight fast, children consumed one of four isocaloric treatment meals (450 kcal) of French fries, mashed potatoes, or white beans served with a fixed portion of egg omelet (30 g of protein), a control meal with cereal, milk, and bread, or continued to fast (i.e., meal skipping). Subjective appetite was measured using visual analogue scales. FI at an ad libitum pizza meal at 180 min and rest of day diet record were used to measure lunch FI and rest of day energy intake, respectively. Total daily energy intake was calculated by adding the energy intake from the treatment meal, the ad libitum pizza lunch, and rest of day food record. Capillary blood samples were collected to assess glycemic response over 180 min. Results:  Change from baseline subjective average appetite scores were lower after mashed potatoes compared with all other treatment conditions (p < 0.001), and higher after French fries compared with white beans (p = 0.04). Lunch FI (kcal) was significantly lower (p < 0.001) after French fries (1010±73) and mashed potatoes (1039±74) compared with the control meal (1257±92) and meal skipping (1235±74). Total daily energy intake (kcal) was lower after French fries compared with the control meal (2228±141 vs. 2624±137; p = 0.04). Change from baseline blood glucose was lower after white beans and French fries compared with mashed potatoes (p < 0.05) and the control meal (p < 0.001). Conclusion:  In conclusion, white potatoes with eggs increased satiety, decreased short-term FI, and resulted in similar energy intakes compared with meal skipping.",2020,Lunch FI (kcal) was significantly lower (p < 0.001) after French fries (1010±73) and mashed potatoes (1039±74) compared with the control meal (1257±92) and meal skipping (1235±74).,"['9-14-year-old children and adolescents', 'Children and Adolescents']","['isocaloric treatment meals (450 kcal) of French fries, mashed potatoes, or white beans served with a fixed portion of egg omelet (30 g of protein), a control meal with cereal, milk, and bread, or continued to fast (i.e., meal skipping', 'White Potatoes']","['baseline blood glucose', 'Subjective appetite', 'satiety, FI, and glycemic response', 'similar energy intakes', 'Satiety, Food Intake, and Glycemic Response', 'glycemic response', 'Lunch FI (kcal', 'baseline subjective average appetite scores', 'Total daily energy intake (kcal', 'Total daily energy intake']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C1510451', 'cui_str': 'Fries'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0446305', 'cui_str': 'White bean (substance)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0007757', 'cui_str': 'Cereal Grain'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",21.0,0.0795284,Lunch FI (kcal) was significantly lower (p < 0.001) after French fries (1010±73) and mashed potatoes (1039±74) compared with the control meal (1257±92) and meal skipping (1235±74).,"[{'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, Ontario, Canada.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Brett', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, Ontario, Canada.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Chang', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, Ontario, Canada.'}, {'ForeName': 'Julia O Totosy', 'Initials': 'JOT', 'LastName': 'de Zepetnek', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, Saskatchewan, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bellissimo', 'Affiliation': 'School of Nutrition, Ryerson University, Toronto, Ontario, Canada.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1620659']
589,31310989,Effects of a Combined Upper- and Lower-Limb Plyometric Training Program on High-Intensity Actions in Female U14 Handball Players.,"PURPOSE


To analyze the effects of a 9-week plyometric training program on the sprint times (5, 10, 20, and 30 m), change-of-direction speed (modified T test and modified Illinois test), jumping (squat jump, countermovement jump, countermovement jump with arms, and horizontal 5-jump test), upper-body strength (right and left handgrip, back extensor strength, and medicine ball throw), and balance (Y and stork balance tests) of female handball players.
METHODS


Athletes were randomly divided into experimental (n = 21; age = 13.5 [0.3] y) and control (n = 20; age = 13.3 [0.3] y) groups. Training exercises and matches were performed together, but the experimental group replaced a part of their normal regimen by biweekly upper- and lower-limb plyometric training.
RESULTS


Both groups improved performance, but to a greater extent in the experimental group compared with controls for 20- and 30-m sprint times (Δ% = 9.6, P < .05, d = 0.557 and Δ% = 20.9, P < .001, d = 1.07, respectively), change of direction (T test: P < .01, Δ% = 14.5, d = 0.993 and Illinois test: P < .01, Δ% = 7.9, d = 0.769), vertical and horizontal jumping (P < .05), all measures of upper-limb strength (P < .001), and left-leg stork balance (P < .001, Δ% = 49.9, d = 1.07).
CONCLUSIONS


A plyometric training program allows female junior handball players to improve important components of their physical performance.",2019,"Both groups improved performance, but to a greater extent in the experimental group compared with controls for 20- and 30-m sprint times (Δ% = 9.6, P < .05, d = 0.557 and Δ% = 20.9, P < .001, d = 1.07, respectively), change of direction (T test: P < .01, Δ% = 14.5, d = 0.993 and Illinois test: P < .01, Δ% = 7.9, d = 0.769), vertical and horizontal jumping (P < .05), all measures of upper-limb strength (P < .001), and left-leg stork balance (P < .001, Δ% = 49.9, d = 1.07).
","['Female U14 Handball Players', 'female junior handball players', 'Athletes were randomly divided into experimental (n = 21; age = 13.5 [0.3]\xa0y) and control (n = 20; age = 13.3 [0.3] y) groups']","['plyometric training program', 'experimental group replaced a part of their normal regimen by biweekly upper- and lower-limb plyometric training', 'Combined Upper- and Lower-Limb Plyometric Training Program']","['left-leg stork balance', 'change of direction', 'vertical and horizontal jumping', 'upper-limb strength', 'change-of-direction speed (modified T test and modified Illinois test), jumping (squat jump, countermovement jump, countermovement jump with arms, and horizontal 5-jump test), upper-body strength (right and left handgrip, back extensor strength, and medicine ball throw), and balance (Y and stork balance tests) of female handball players']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0325459', 'cui_str': 'Stork'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0560512', 'cui_str': 'Does throw (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0336936', 'cui_str': 'Handball'}]",,0.00907494,"Both groups improved performance, but to a greater extent in the experimental group compared with controls for 20- and 30-m sprint times (Δ% = 9.6, P < .05, d = 0.557 and Δ% = 20.9, P < .001, d = 1.07, respectively), change of direction (T test: P < .01, Δ% = 14.5, d = 0.993 and Illinois test: P < .01, Δ% = 7.9, d = 0.769), vertical and horizontal jumping (P < .05), all measures of upper-limb strength (P < .001), and left-leg stork balance (P < .001, Δ% = 49.9, d = 1.07).
","[{'ForeName': 'Mehrez', 'Initials': 'M', 'LastName': 'Hammami', 'Affiliation': 'University of ""La Manouba"".'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Universidad de Los Lagos.'}, {'ForeName': 'Nawel', 'Initials': 'N', 'LastName': 'Gaamouri', 'Affiliation': 'University of ""La Manouba"".'}, {'ForeName': 'Gaith', 'Initials': 'G', 'LastName': 'Aloui', 'Affiliation': 'University of ""La Manouba"".'}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Shephard', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Mohamed Souhaiel', 'Initials': 'MS', 'LastName': 'Chelly', 'Affiliation': 'University of ""La Manouba"".'}]",Pediatric exercise science,['10.1123/pes.2018-0278']
590,31305326,Effects of Conventional Milk Versus Milk Containing Only A2 β-Casein on Digestion in Chinese Children: A Randomized Study.,"OBJECTIVES


In this study, we hypothesized that replacing conventional milk, which contains A1 and A2 β-casein proteins, with milk that contains only A2 β-casein in the diet of dairy or milk-intolerant preschoolers (age 5 to 6 years) would result in reduced gastrointestinal symptoms associated with milk intolerance, and that this would correspond with cognitive improvements.
METHODS


This randomized, double-blind, crossover study aimed to compare the effects of 5 days' consumption of conventional milk versus milk containing only A2 β-casein on gastrointestinal symptoms, as assessed via visual analog scales, average stool frequency and consistency, and serum inflammatory and immune biomarkers in healthy preschoolers with mild-to-moderate milk intolerance. The study also aimed to compare changes in the cognitive behavior of preschoolers, based on Subtle Cognitive Impairment Test scores.
RESULTS


Subjects who consumed milk containing only A2 β-casein had significantly less severe gastrointestinal symptoms as measured by visual analog scales, reduced stool frequency, and improvements in stool consistency, compared with subjects consuming conventional milk. There were significant increases from baseline in serum interleukin-4, immunoglobulins G, E, and G1, and beta-casomorphin-7 coupled to lower glutathione levels, in subjects consuming conventional milk compared with milk containing only A2 β-casein. Subtle Cognitive Impairment Test analysis showed significant improvements in test accuracy after consumption of milk containing only A2 β-casein. There were no severe adverse events related to consumption of either milk product.
CONCLUSIONS


Replacing conventional milk with milk containing only A2 β-casein reduced gastrointestinal symptoms associated with milk intolerance in Chinese preschool children, with corresponding improvements in aspects of cognitive performance.",2019,"There were significant increases from baseline in serum interleukin-4, immunoglobulins G, E, and G1, and beta-casomorphin-7 coupled to lower glutathione levels, in subjects consuming conventional milk compared with milk containing only A2 β-casein.","['Chinese preschool children', 'Chinese Children', 'healthy preschoolers with mild-to-moderate milk intolerance']","['Conventional Milk Versus Milk Containing Only A2 β-Casein', 'replacing conventional milk, which contains A1 and A2 β-casein proteins, with milk that contains only A2 β-casein', 'conventional milk versus milk containing only A2 β-casein']","['gastrointestinal symptoms', 'serum interleukin-4, immunoglobulins G, E, and G1, and beta-casomorphin-7 coupled to lower glutathione levels', 'visual analog scales, reduced stool frequency, and improvements in stool consistency', 'gastrointestinal symptoms, as assessed via visual analog scales, average stool frequency and consistency, and serum inflammatory and immune biomarkers', 'severe gastrointestinal symptoms', 'cognitive performance']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0022951', 'cui_str': 'Milk Sugar Intolerance'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0202087', 'cui_str': 'Immunoglobulin G measurement (procedure)'}, {'cui': 'C0053401', 'cui_str': 'tyrosyl-prolyl-phenylalanyl-prolylglycyl-prolyl-isoleucine'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0535331,"There were significant increases from baseline in serum interleukin-4, immunoglobulins G, E, and G1, and beta-casomorphin-7 coupled to lower glutathione levels, in subjects consuming conventional milk compared with milk containing only A2 β-casein.","[{'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': ""Department of Children and Adolescents Health Care, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, MOE-Shanghai Key Lab for Children's Environmental Health, Shanghai.""}, {'ForeName': 'Zailing', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Pediatric Gastroenterology, Peking University Third Hospital, Beijing.'}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'S.P.R.I.M. China (Shanghai) Consulting Co., Ltd., Shanghai, China.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Yelland', 'Affiliation': 'School of Health Sciences, RMIT University, Bundoora.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002437']
591,31289017,Continuous intracoronary versus standard intravenous infusion of adenosine for fractional flow reserve assessment: the HYPEREMIC trial.,"AIMS


The aim of this study was to evaluate the accuracy of a continuous intracoronary (IC) adenosine infusion, administered through the novel HYPEREM™IC over-the-wire microcatheter, to measure fractional flow reserve (FFR).
METHODS AND RESULTS


The HYPEREMIC trial was a randomised, non-inferiority, crossover study in which patients with intermediate coronary lesions were enrolled for sequential pressure wire studies. FFR was measured using intravenous (IV) (140-180 mcg/kg/min) versus continuous non-weight-adjusted IC (360 mcg/min) adenosine. Patients were randomised and blinded to the order in which they received the adenosine, separated by a washout period. The primary endpoint was the mean hyperaemic FFR. Forty-one patients were enrolled at three UK sites between June and November 2016. The mean (standard deviation) FFR was 0.82 (±0.09) after IC versus 0.84 (±0.09) after IV adenosine. The difference of -0.02 (95% confidence interval [CI]: -0.03 to -0.01) confirmed the non-inferiority (margin <0.05) of IC to IV adenosine. Intracoronary adenosine was associated with a shorter mean time to maximal hyperaemia (difference -44 [95% CI: -59 to -29] seconds; p<0.0001). Chest discomfort was reported in 32/41 (78.0%) patients during IV adenosine versus 12/41 (29.3%) patients during IC adenosine.
CONCLUSIONS


Continuous IC adenosine was a reliable, faster and better tolerated method of achieving maximal hyperaemia compared to IV adenosine.",2020,"CONCLUSIONS


Continuous IC adenosine was a reliable, faster and better-tolerated method of achieving maximal hyperaemia compared to IV adenosine.","['Forty-one patients were enrolled at 3 UK sites between June and November 2016', 'patients with intermediate coronary lesions were enrolled for sequential pressure wire studies']","['continuous intracoronary (IC) adenosine infusion', 'Adenosine', 'Intracoronary adenosine', 'adenosine']","['mean hyperaemic FFR', 'fractional flow reserve (FFR', 'mean time to maximal hyperaemia', 'Chest discomfort', 'FFR', 'mean (standard deviation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0005978', 'cui_str': 'Bone Wires'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0235710', 'cui_str': 'Chest discomfort (finding)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",41.0,0.0844442,"CONCLUSIONS


Continuous IC adenosine was a reliable, faster and better-tolerated method of achieving maximal hyperaemia compared to IV adenosine.","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': 'Cardiology Department, Northwick Park Hospital, London North West Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Myat', 'Affiliation': ''}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Belder', 'Affiliation': ''}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Collison', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Cocks', 'Affiliation': ''}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ''}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Oldroyd', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-18-01067']
592,30251049,The use of hydrogel spacer in men undergoing high-dose prostate cancer radiotherapy: results of a prospective phase 2 clinical trial.,"PURPOSE


The purpose of this study was to determine whether the degree of prostate to rectal separation using a hydrogel spacer (HS) and its effect on decreasing rectal dose can be reproduced in the community setting.
METHODS


Thirty one patients with cT1-3aN0M0 prostate adenocarcinoma receiving radical radiotherapy to 78 Gy were recruited to the study. The primary endpoint was the proportion of patients achieving at least 25% reduction in volume of rectum receiving 70 Gy (rV70). Other endpoints included degree of prostate to rectum separation, HS insertion-related adverse events and the proportion of patients with grade 1 or worse acute or late gastrointestinal (GI) and genitourinary (GU) toxicity.
RESULTS


All patients had successful insertion of their HS with no peri-operative toxicity. The mean prostate-rectal separation achieved was 10.5 mm. Twenty nine (93.5%) patients achieved a reduction in rV70 of at least 25%. Acute grade 1 GI toxicity was reported in 3 patients. All symptoms had resolved by 3 months post RT. Late grade 1 GI toxicity was reported in one patient (3.2%) with bowel frequency occurring at 6 months and resolving by 12 months post RT. There was no grade 2 or 3 acute or late GI toxicity seen.
CONCLUSION


In conclusion, this study illustrates that the application and benefits of HS on reducing GI rectal dose endpoints and toxicities during prostate cancer RT can be reliably replicated in a community setting similar to centres participating in the randomised trial under high quality assurance trial monitoring.",2019,"There was no grade 2 or 3 acute or late GI toxicity seen.
","['men undergoing high-dose prostate cancer', 'Thirty one patients with cT1-3aN0M0 prostate adenocarcinoma receiving radical radiotherapy to 78\xa0Gy were recruited to the study']","['HS', 'hydrogel spacer', 'hydrogel spacer (HS', 'radiotherapy']","['degree of prostate to rectum separation, HS insertion-related adverse events and the proportion of patients with grade 1 or worse acute or late gastrointestinal (GI) and genitourinary (GU) toxicity', 'grade 2 or 3 acute or late GI toxicity seen', 'Late grade 1 GI toxicity', 'proportion of patients achieving at least 25% reduction in volume of rectum receiving 70\xa0Gy (rV70', 'Acute grade 1 GI toxicity', 'mean prostate-rectal separation', 'successful insertion of their HS with no peri-operative toxicity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0221874', 'cui_str': 'Spacer (physical object)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",31.0,0.099508,"There was no grade 2 or 3 acute or late GI toxicity seen.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chao', 'Affiliation': 'Genesis Cancer Care Victoria, 36 Mt Dandenong Road, Ringwood East, VIC, 3135, Australia. Michael.Chao@genesiscare.com.au.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Lim Joon', 'Affiliation': 'The Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Khoo', 'Affiliation': 'The Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Lawrentschuk', 'Affiliation': 'The Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Ho', 'Affiliation': 'Genesis Cancer Care Victoria, 36 Mt Dandenong Road, Ringwood East, VIC, 3135, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Spencer', 'Affiliation': 'Genesis Cancer Care Victoria, 36 Mt Dandenong Road, Ringwood East, VIC, 3135, Australia.'}, {'ForeName': 'Yee', 'Initials': 'Y', 'LastName': 'Chan', 'Affiliation': 'The Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'The Bays Hospital, Mornington, Australia.'}, {'ForeName': 'Trung', 'Initials': 'T', 'LastName': 'Pham', 'Affiliation': 'The Valley Private Hospital, Mulgrave, Australia.'}, {'ForeName': 'Shomik', 'Initials': 'S', 'LastName': 'Sengupta', 'Affiliation': 'The Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McMillan', 'Affiliation': 'Ringwood Private Hospital, Ringwood East, Australia.'}, {'ForeName': 'Madalena', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Ringwood Private Hospital, Ringwood East, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Koufogiannis', 'Affiliation': 'Ringwood Private Hospital, Ringwood East, Australia.'}, {'ForeName': 'Chee Wee', 'Initials': 'CW', 'LastName': 'Cham', 'Affiliation': 'The Bays Hospital, Mornington, Australia.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Foroudi', 'Affiliation': 'The Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Bolton', 'Affiliation': 'The Austin Hospital, Heidelberg, Australia.'}]",World journal of urology,['10.1007/s00345-018-2502-5']
593,31270101,Effects of Switching to a Heat-Not-Burn Tobacco Product on Biologically Relevant Biomarkers to Assess a Candidate Modified Risk Tobacco Product: A Randomized Trial.,"BACKGROUND


Cigarette smoking increases the risk of chronic diseases; heating instead of burning tobacco can lower these risks, contributing to tobacco harm reduction. This study (with 984 adult American smokers) examined whether favorable changes occur in 8 co-primary endpoints (HDL-C, WBC, FEV 1 %pred, COHb, Total NNAL, sICAM-1, 11-DTX-B2, 8-epi-PGF2α) indicative of biological and functional effects when cigarette smokers switch to the heat-not-burn Tobacco Heating System 2.2 (THS). Additionally, these biomarkers of exposure (BoExp) were quantified: MHBMA, 3-HPMA, Total NNN, CEMA, 3-OH-B[a]P, HMPMA, Total 1-OHP, NEQ, and CO exhaled.
METHODS


Participants were randomized to continued smoking of their preferred cigarette brand ( n  = 496) or to using THS (IQOS brand;  n  = 488) for 6 months. THS has a maximum heating temperature of 350°C, delivering 1.21 mg nicotine/stick and 3.94 mg glycerin/stick under the Health Canada Intense smoking regimen.
RESULTS


The main outcome was a favorable change 6 months after baseline, with statistically significant improvements in 5 of 8 biomarkers of effect (HDL-C, WBC, FEV 1 %pred, COHb, Total NNAL) when smokers switched to THS compared with those who continued to smoke cigarettes. Likewise, BoExp were markedly reduced.
CONCLUSIONS


All endpoints showed favorable changes in the same direction as with smoking cessation and improved biological effects were observed in smokers who predominantly used THS compared with continued cigarette smoking, with similar nicotine levels in both groups.
IMPACT


Improvements in 5 of 8 biomarkers of effect are supportive of the research hypothesis, suggestive of disease risk reduction potential for smokers switching to THS instead of continuing to smoke cigarettes.",2019,"All endpoints showed favorable changes in the same direction as with smoking cessation and improved biological effects were observed in smokers who predominantly used THS compared with continued cigarette smoking, with similar nicotine levels in both groups.
","['Participants were randomized to continued smoking of their preferred cigarette brand (n = 488) or to using', '984 adult American smokers']","['THS (IQOS brand', 'THS', 'Heat-Not-Burn Tobacco Product']",['biological effects'],"[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",984.0,0.0149522,"All endpoints showed favorable changes in the same direction as with smoking cessation and improved biological effects were observed in smokers who predominantly used THS compared with continued cigarette smoking, with similar nicotine levels in both groups.
","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lüdicke', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland. frank.luedicke@pmi.com.'}, {'ForeName': 'S Michael', 'Initials': 'SM', 'LastName': 'Ansari', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lama', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Blanc', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Bosilkovska', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Donelli', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Picavet', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Gizelle', 'Initials': 'G', 'LastName': 'Baker', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Haziza', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Peitsch', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Weitkunat', 'Affiliation': 'Philip Morris International R&D, Philip Morris Products S.A., Neuchâtel, Switzerland.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-18-0915']
594,31880167,Compassion-focused self-help for psychological distress associated with skin conditions: a randomized feasibility trial.,"Objective:  This study tested the feasibility of a self-help intervention based on Compassion-Focused Theory (CFT), and estimated treatment effects in a population of adults with skin conditions and associated psychological distress. Design:  A randomized-controlled design was used, with 176 participants being allocated to either CFT-based self-help or a waitlist control group, who received usual medical care. The two-week intervention was provided by email. Main Outcome Measures:  Treatment adherence and attrition rates were calculated, and effectiveness was estimated using measures of perceived stress, anxiety, depression, dermatology-specific quality of life and self-compassion. Results:  Eighty-seven participants completed the post-intervention questionnaires (51%), and practiced on a median of 9/14 days. Study completers demonstrated significant, moderate improvements on measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls. In intention-to-treat (ITT) analyses, these findings remained significant, however effect sizes reduced from moderate to small. Conclusions:  The findings indicate that CFT self-help shows promise in the treatment of psychological distress associated with skin conditions, however further testing of the intervention is not feasible without significant methodological changes, including the method of treatment delivery. Future studies should also include a follow-up period, as the duration of treatment effects could not be shown.",2020,"Study completers demonstrated significant, moderate improvements on measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls.","['population of adults with skin conditions and associated psychological distress', '176 participants being allocated to either']","['Compassion-focused self-help', 'CFT-based self-help or a waitlist control group, who received usual medical care', 'self-help intervention based on Compassion-Focused Theory (CFT']","['post-intervention questionnaires', 'adherence and attrition rates were calculated, and effectiveness was estimated using measures of perceived stress, anxiety, depression, dermatology-specific quality of life and self-compassion', 'measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1719933', 'cui_str': 'Skin condition'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",87.0,0.0307342,"Study completers demonstrated significant, moderate improvements on measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls.","[{'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Hudson', 'Affiliation': 'Department of Psychology, Clinical Psychology Unit, Western Bank, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Thompson', 'Affiliation': 'Department of Psychology, Clinical Psychology Unit, Western Bank, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Lisa-Marie', 'Initials': 'LM', 'LastName': 'Emerson', 'Affiliation': 'Department of Psychology, Clinical Psychology Unit, Western Bank, The University of Sheffield, Sheffield, UK.'}]",Psychology & health,['10.1080/08870446.2019.1707829']
595,31801872,"Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial.","OBJECTIVE


This trial compared the efficacy and safety of transarterial chemoembolisation (TACE) plus sorafenib with TACE alone using a newly established TACE-specific endpoint and pre-treatment of sorafenib before initial TACE.
DESIGN


Patients with unresectable hepatocellular carcinoma (HCC) were randomised to TACE plus sorafenib (n=80) or TACE alone (n=76). Patients in the combination group received sorafenib 400 mg once daily for 2-3 weeks before TACE, followed by 800 mg once daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP), defined as untreatable tumour progression, transient deterioration to Child-Pugh C or appearance of vascular invasion/extrahepatic spread. Co-primary endpoints were progression-free survival (PFS), which is not a conventional one but defined as TTUP, or time to any cause of death plus overall survival (OS). Multiplicity was adjusted by gatekeeping hierarchical testing.
RESULTS


Median PFS was significantly longer in the TACE plus sorafenib than in the TACE alone group (25.2 vs 13.5 months; p=0.006). OS was not analysed because only 73.6% of OS events were reached. Median TTUP (26.7 vs 20.6 months; p=0.02) was also significantly longer in the TACE plus sorafenib group. OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively. There were no unexpected toxicities.
CONCLUSION


TACE plus sorafenib significantly improved PFS over TACE alone in patients with unresectable HCC. Adverse events were consistent with those of previous TACE combination trials.
TRIAL REGISTRATION NUMBER


NCT01217034.",2020,"OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively.","['patients with unresectable HCC', 'patients with hepatocellular carcinoma', 'Patients with unresectable hepatocellular carcinoma (HCC']","['transarterial chemoembolisation (TACE) plus sorafenib', 'sorafenib 400\u2009mg once daily for 2-3 weeks before TACE, followed by 800\u2009mg once daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP', 'transarterial chemoembolisation (TACE) plus sorafenib with TACE', 'TACE', 'Median TTUP', 'TACE alone', 'TACE plus sorafenib']","['toxicities', 'TTUP, or time to any cause of death plus overall survival (OS', 'progression-free survival (PFS', 'efficacy and safety', 'Adverse events', 'PFS', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0529196', 'cui_str': 'ADAM-17 Protein'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0007465', 'cui_str': 'Cause of Death'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0496813,"OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively.","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan m-kudo@med.kindai.ac.jp.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Ueshima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Torimura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Nobukazu', 'Initials': 'N', 'LastName': 'Tanabe', 'Affiliation': 'Department of Gastroenterology, National Hospital Organisation Sendai Medical Center, Sendai, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Aikata', 'Affiliation': 'Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube-Yamaguchi, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Nojiri', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hino', 'Affiliation': 'Department of Hepatology and Pancreatology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Tsumura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Teiji', 'Initials': 'T', 'LastName': 'Kuzuya', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Isoda', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Kohichiroh', 'Initials': 'K', 'LastName': 'Yasui', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Aino', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Social Insurance Tagawa Hospital, Tagawa, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Ido', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kawabe', 'Affiliation': 'Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'Department of Hepato-Biliary-Pancreatic Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yokosuka', 'Affiliation': 'Department of Gastroenterology, School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kokudo', 'Affiliation': 'Department of Surgery, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiwamu', 'Initials': 'K', 'LastName': 'Okita', 'Affiliation': 'Deapartment of Medicine, Shunan Memorial Hospital, Kudamatsu, Yamaguchi, Japan.'}, {'ForeName': 'Philip James', 'Initials': 'PJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gut,['10.1136/gutjnl-2019-318934']
596,32409493,Exercise-Induced Increases in Insulin Sensitivity After Bariatric Surgery Are Mediated By Muscle Extracellular Matrix Remodeling.,"Exercise seems to enhance the beneficial effect of bariatric (Roux-en-Y gastric bypass [RYGB]) surgery on insulin resistance. We hypothesized that skeletal muscle extracellular matrix (ECM) remodeling may underlie these benefits. Women were randomized to either a combined aerobic and resistance exercise training program following RYGB (RYGB + ET) or standard of care (RYGB). Insulin sensitivity was assessed by oral glucose tolerance test. Muscle biopsy specimens were obtained at baseline and 3 and 9 months after surgery and subjected to comprehensive phenotyping, transcriptome profiling, molecular pathway identification, and validation in vitro. Exercise training improved insulin sensitivity beyond surgery alone (e.g., Matsuda index: RYGB 123% vs. RYGB + ET 325%;  P  ≤ 0.0001). ECM remodeling was reduced by surgery alone, with an additive benefit of surgery and exercise training (e.g., collagen I: RYGB -41% vs. RYGB + ET -76%;  P  ≤ 0.0001). Exercise and RYGB had an additive effect on enhancing insulin sensitivity, but surgery alone did not resolve insulin resistance and ECM remodeling. We identified candidates modulated by exercise training that may become therapeutic targets for treating insulin resistance, in particular, the transforming growth factor-β1/SMAD 2/3 pathway and its antagonist follistatin. Exercise-induced increases in insulin sensitivity after bariatric surgery are at least partially mediated by muscle ECM remodeling.",2020,"Exercise and RYGB had an additive effect on enhancing insulin sensitivity, but surgery alone did not resolve insulin resistance and ECM remodeling.",[],"['surgery and exercise training ( e.g.,  collagen', 'combined aerobic and resistance exercise training program following RYGB or standard of care (RYGB', 'I - RYGB', 'exercise training']","['enhancing insulin sensitivity', 'ECM remodeling', 'insulin resistance and ECM remodeling', 'Insulin Sensitivity', 'insulin sensitivity', 'Insulin sensitivity']",[],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015350', 'cui_str': 'Matrix, Extracellular'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.0522588,"Exercise and RYGB had an additive effect on enhancing insulin sensitivity, but surgery alone did not resolve insulin resistance and ECM remodeling.","[{'ForeName': 'Wagner S', 'Initials': 'WS', 'LastName': 'Dantas', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Laboratory of Assessment and Conditioning in Rheumatology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Igor H', 'Initials': 'IH', 'LastName': 'Murai', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Laboratory of Assessment and Conditioning in Rheumatology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Laboratory of Assessment and Conditioning in Rheumatology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gangarao', 'Initials': 'G', 'LastName': 'Davuluri', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Sujoy', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Genomics Core, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Newman', 'Affiliation': 'Genomics Core, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Shinjo', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Willian', 'Initials': 'W', 'LastName': 'das Neves', 'Affiliation': 'Clinical Oncology Service, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Merege-Filho', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Laboratory of Assessment and Conditioning in Rheumatology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Walcy R', 'Initials': 'WR', 'LastName': 'Teodoro', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vera L', 'Initials': 'VL', 'LastName': 'Capelozzi', 'Affiliation': 'Department of Pathology, School of Medicine, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Pereira', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fabiana B', 'Initials': 'FB', 'LastName': 'Benatti', 'Affiliation': 'School of Applied Sciences, Universidade Estadual de Campinas, São Paulo, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'de Sá-Pinto', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'de Cleva', 'Affiliation': 'Department of Digestive Division, School of Medicine, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Department of Digestive Division, School of Medicine, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Laboratory of Assessment and Conditioning in Rheumatology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil gualano@usp.br.'}]",Diabetes,['10.2337/db19-1180']
597,31801937,Effects of intranasal oxytocin administration on empathy and approach motivation in women with borderline personality disorder: a randomized controlled trial.,"Borderline personality disorder (BPD) is characterized by severe interpersonal dysfunction with problems in social cognition, empathy and social approach. Although the neuropeptide oxytocin is known to regulate complex social cognition and behavior in healthy individuals and clinical populations, there is still a lack of evidence for a potential beneficial effect of oxytocin administration on social cognition and social approach in BPD. Fifty-one women with BPD and 51 matched healthy controls were randomized to a double-blind, placebo-controlled, between-subject experimental trial. We administered a single dose of 24 IU oxytocin or placebo intranasally prior to a standardized task measuring affective and cognitive empathy and approach motivation. All participants were free of hormonal contraception and tested in the mid-luteal phase of their menstrual cycle. In the placebo condition, patients with BPD showed reduced cognitive and affective empathy, and less approach behavior motivation than healthy controls. Intranasal oxytocin significantly increased affective empathy and approach motivation in both BPD patients and healthy controls compared to placebo. More importantly, oxytocin administration led to similar scores between BPD and healthy controls. These findings provide the first evidence for a beneficial effect of oxytocin on deficits in affective empathy and approach motivation of BPD. Our results indicate a beneficial effect of a single dose of oxytocin on affective empathy and approach motivation in women with BPD adapting their level of social functioning to healthy controls. Future clinical trials will need to investigate the long-term effects and effectiveness of oxytocin as an add-on treatment for social impairments in BPD.",2019,"In the placebo condition, patients with BPD showed reduced cognitive and affective empathy, and less approach behavior motivation than healthy controls.","['women with BPD adapting their level of social functioning to healthy controls', 'Fifty-one women with BPD and 51 matched healthy controls', 'healthy individuals and clinical populations', 'Borderline personality disorder (BPD', 'women with borderline personality disorder', 'All participants were free of hormonal contraception and tested in the mid-luteal phase of their menstrual cycle']","['oxytocin', 'placebo', 'Intranasal oxytocin', 'neuropeptide oxytocin', 'intranasal oxytocin', 'oxytocin or placebo']","['reduced cognitive and affective empathy', 'approach behavior motivation', 'affective empathy and approach motivation', 'empathy and approach motivation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C4046027', 'cui_str': 'Approach Behavior'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",51.0,0.175967,"In the placebo condition, patients with BPD showed reduced cognitive and affective empathy, and less approach behavior motivation than healthy controls.","[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Domes', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany. domes@uni-trier.de.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ower', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'von Dawans', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Franny B', 'Initials': 'FB', 'LastName': 'Spengler', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Dziobek', 'Affiliation': 'Department of Psychology, Clinical Psychology of Social Interaction, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bohus', 'Affiliation': 'Institute of Psychosomatic and Psychiatric Psychotherapy, Central Institute of Mental Health, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Matthies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany. heinrichs@psychologie.uni-freiburg.de.'}]",Translational psychiatry,['10.1038/s41398-019-0658-4']
598,31804398,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE


To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA


Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS


Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS


126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS


No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2019,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'absorbable or nonabsorbable mesh repair']","['clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'chest pain, diarrhea, and bloat symptoms', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal (procedure)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
599,31259802,Improved Reduction of the Tibio-Fibular Syndesmosis with Tightrope compared to Screw Fixation: Results of a Randomized Controlled Study.,"OBJECTIVE


To compare the rate of malreduction following high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device.
DESIGN


Prospective randomized controlled multicenter trial SETTING:: Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment.
METHODS


Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either Tightrope (one knotless Tightrope, Group T) or screw fixation (two 3.5 mm cortical positional screws placed across 3 cortices, Group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the Tightrope device. Follow up was performed at 2 and 6 weeks, 3, 6 and 12 months.
MAIN OUTCOME MEASURE


Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI). The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only.
RESULTS


Overall, the rate of malreduction using screw fixation was 39 % compared with 15 % using Tightrope fixation (p = 0.028, Chi square). Analysis of CT results was performed using a 2 mm translation or 10 degree rotation threshold for malreduction, and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular). Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05). Group T syndesmoses also had greater diastasis compared to control limb (4.1 ± 1.3 vs 3.3 ± 1.4 mm, p<0.01) and less fibular medialization compared to Group S (1.04 ± 1.8 vs 0.3± 1.8 mm, p = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. FADI scores at each time interval were: 44 ± 22 (T) vs 45 ± 24 (S) (6 weeks), 76 ± 14 vs 73 ± 17 (3 months), 89 ± 10 vs 86 ± 13 (6 months), and 93 ± 9 vs 90 ± 14 (12 months) (all p > 0.2). The reoperation rate was higher in the screw group compared to Tightrope (30% vs 4%, p= 0.02) with the difference driven by the rate of implant removal.
CONCLUSION


Based upon our results the Tightrope device appears to compare favorably to two, 3.5 mm, 3- cortex screw fixation for syndesmosis injuries.",2019,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[' Eleven academic and community hospitals including level 1 and 2 trauma centers across CanadaPatients/Participants: One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability following malleolar bony fixation were followed for 12 months after treatment', 'syndesmosis injuries']","['Tightrope (one knotless Tightrope, Group T) or screw fixation', 'syndesmosis injury treated with open reduction and internal fixation, with either two screws or one knotless Tightrope device', 'Screw Fixation', '3- cortex screw fixation']","['rate of malreduction using screw fixation', 'Rate of malreduction based on bilateral ankle CT scan results at 3 months post fixation', 'greater anterior translation', 'fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, mid); medial compression; and rotation (fibular and articular', 'FADI scores', 'reoperation rate', 'adverse events, reoperation, and validated functional outcomes including the EQ5D, the Olerud-Molander Ankle Score (OM), the Foot and Ankle Disability Index (FADI), and the Work Productivity Activity Impairment Questionnaire (WPAI', 'rate of implant removal', 'fibular medialization']","[{'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0036679', 'cui_str': 'Separation (morphologic abnormality)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant (procedure)'}]",103.0,0.107881,"Patients in Group T had greater anterior translation (5.4 ± 1.8 mm) compared to the contralateral limb (4.3 ± 1.3 mm, p<0.01) or Group S (4.6 ± 1.5 mm, p = 0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Prism', 'Initials': 'P', 'LastName': 'Schneider', 'Affiliation': 'Foothills Medical Centre McCaig Tower, 3134 Hospital Drive NW, Calgary, Alberta CANADA T2N 5A1 Tel: (403) 944-4518 Fax: (403) 270-8004.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-324, London, Ontario CANADA N6A 4G5 Tel: 519-685-8086 Fax: 519-685-8019.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-414London, Ontario CANADA N6A 4G5 Tel: 519-685-8500 x 55362 Fax: 519-685-8059.'}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'London Health Sciences Centre, Victoria Hospital 800 Commissioners Rd E, E1-325, London, Ontario CANADA N6A 4G5 Tel: 519-685-8218 Fax: 519-685-8059 800 Commissioners Road East, Room E1-326 London, Ontario CANADA N6A 4G5 Tel: (519) 685-8086 Fax: (519) 685-8016 Email: david.sanders@lhsc.on.ca.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001559']
600,31778862,Effectiveness of empathy clinical education for children's nursing students: A quasi-experimental study.,"BACKGROUND


Empathy is a central competence for nursing students in delivering compassionate care. Empathy training might improve the communication skills in children's nursing students.
OBJECTIVES


To evaluate the effectiveness of the Knowledge, Simulation, and Sharing training programme on empathy skills among children's nursing students.
DESIGN


A controlled pre-post intervention study with a quasi-experimental design.
SETTING


Tertiary children's hospital in China.
PARTICIPANTS


Children's nursing students (n = 250) in clinical internship.
METHODS


A Knowledge, Simulation, and Sharing (KSS) module related to empathy learning was developed and tested during a 10-month period in 2017. Nursing students were divided into an experimental group (n = 125) and control group (n = 125). Both groups received the standard internship programme. The experimental group received the KSS training. Outcome measures were: Jefferson Scale of Empathy-Health Professions Student, Clinical Communication Competence Scale and Professional Identity Scale.
RESULTS


At the end of the internship the experimental groups had significantly higher empathy scores than the control group (114.57 versus 110.36; p = .016). The communication skills improved significantly in the experimental group after the training; experimental group mean 90.22 versus control group mean 87.41 (p = .042). The professional identity scores were significantly higher in the experimental group at the end of the internship compared to the control group (mean 116.43 versus 107.68; p < .001). Subgroup analysis revealed only significant differences on professional identity outcomes between experimental and control groups on diploma level (mean 115.78 versus 107.72; p < .001); and bachelor's level (mean 120.05 versus 108.00; p < .016).
CONCLUSION


The KSS training can enhance empathy and communication skills and the professional identity in children's nursing students. Further long-term effectiveness of the training needs to be tested, ideally with reported outcomes measures of children and parents.",2020,The professional identity scores were significantly higher in the experimental group at the end of the internship compared to the control group (mean 116.43 versus 107.68; p < .001).,"['children and parents', ""children's nursing students"", ""Children's nursing students (n\u202f=\u202f250) in clinical internship"", 'Nursing students', ""Tertiary children's hospital in China"", 'nursing students in delivering compassionate care']","['standard internship programme', 'empathy clinical education', 'Sharing training programme', 'Empathy training', 'KSS training']","['empathy skills', 'professional identity scores', 'empathy and communication skills', 'empathy scores', 'communication skills', 'professional identity outcomes', 'Jefferson Scale of Empathy-Health Professions Student, Clinical Communication Competence Scale and Professional Identity Scale', ""bachelor's level"", 'diploma level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0021793', 'cui_str': 'Internship'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021793', 'cui_str': 'Internship'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0222045'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0337600', 'cui_str': 'Bachelor (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0188034,The professional identity scores were significantly higher in the experimental group at the end of the internship compared to the control group (mean 116.43 versus 107.68; p < .001).,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': ""Nursing Department, Hunan Children's Hospital, Changsha, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Nursing Department, Hunan Children's Hospital, Changsha, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Nursing School, Hunan University of Chinese Medicine, Changsha, China.'}, {'ForeName': 'Dong-Ya', 'Initials': 'DY', 'LastName': 'Li', 'Affiliation': 'Nursing School, Hunan University of Chinese Medicine, Changsha, China.'}, {'ForeName': 'Bing-Ya', 'Initials': 'BY', 'LastName': 'Zheng', 'Affiliation': 'Imaging Faculty, Changsha Medical University, Changsha, China.'}, {'ForeName': 'Shi-Wen', 'Initials': 'SW', 'LastName': 'He', 'Affiliation': 'Nursing Department, Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Li-Hui', 'Initials': 'LH', 'LastName': 'Zhu', 'Affiliation': ""Nursing Department, Hunan Children's Hospital, Changsha, China. Electronic address: 877845375@qq.com.""}, {'ForeName': 'Jos M', 'Initials': 'JM', 'LastName': 'Latour', 'Affiliation': ""Nursing Department, Hunan Children's Hospital, Changsha, China; Faculty of Health and Human Sciences, School of Nursing and Midwifery, University of Plymouth, Plymouth, United Kingdom.""}]",Nurse education today,['10.1016/j.nedt.2019.104260']
601,31785569,To evaluate the effect of challenge-based learning on the approaches to learning of Chinese nursing students: A quasi-experimental study.,"Challenge-based learning (CBL) is a learner-centred, experimental learning strategy that aims to prepare students to manage unforeseeable and complex global issues in the 21st century. It cultivates an active and authentic learning environment that requires students' creative input, collaboration and community involvement. Studies in the past decade have shown that CBL strengthens soft skills essential for future society, such as critical thinking and creativity. However, its effect on students' metacognitive abilities is scarcely mentioned. This study - a quasi-experimental study with non-equivalent groups conducted in a self-financing tertiary institution in Hong Kong - aims to evaluate the effect of CBL on approaches to learning among nursing students. First-year students in the nursing programme who attended a nursing course using CBL were recruited for the intervention group and senior year-one students were included in the control group. Their approach to learning was measured by the Revised Two-Factor Study Process Questionnaire administered at the beginning and at the end of the semester. Analysis of Covariance (ANCOVA) was used to compare the mean difference in scores of deep and surface approaches between the groups. A total of 209 participants were recruited, with 130 in the intervention group and 79 in the control group. The response rates were 65.3% (130/199) and 78.2% (79/101) for the intervention and control groups, respectively. In the intervention group, the mean post-test deep approach score was significantly higher than the pre-test score (F = 5.2, p = 0.023), even though it had only a small effect. There was no statistically significant difference in baseline post-test mean surface scores (F = 2.4, p = 0.125). The results of this study indicate that CBL may facilitate deep learning in nursing students.",2020,"The response rates were 65.3% (130/199) and 78.2% (79/101) for the intervention and control groups, respectively.","['Chinese nursing students', 'nursing students', 'A total of 209 participants were recruited, with 130 in the intervention group and 79 in the control group', 'First-year students in the nursing programme who attended a nursing course using CBL were recruited for the intervention group and senior year-one students were included in the control group']","['challenge-based learning', 'Challenge-based learning (CBL', 'CBL']","['mean post-test deep approach score', 'response rates']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1265318', 'cui_str': 'Cytophaga-like bacteria (organism)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1265318', 'cui_str': 'Cytophaga-like bacteria (organism)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",209.0,0.026567,"The response rates were 65.3% (130/199) and 78.2% (79/101) for the intervention and control groups, respectively.","[{'ForeName': 'Anson C Y', 'Initials': 'ACY', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, Tung Wah College, 31 Wylie Road, Homantin, Kowloon, Hong Kong. Electronic address: ansontang@twc.edu.hk.'}, {'ForeName': 'Meyrick C M', 'Initials': 'MCM', 'LastName': 'Chow', 'Affiliation': 'School of Nursing, Tung Wah College, 31 Wylie Road, Homantin, Kowloon, Hong Kong. Electronic address: meyrickchow@twc.edu.hk.'}]",Nurse education today,['10.1016/j.nedt.2019.104293']
602,31233269,Effects of Message Framing on Patients' Perceptions and Willingness to Change to a Biosimilar in a Hypothetical Drug Switch.,"OBJECTIVE


Patients often hold negative perceptions toward biosimilars that can create barriers to their uptake. Physicians also report uncertainty in how best to explain biosimilars. The aim of this study was to measure the effect of differently framed explanations on patients' perceptions of and willingness to change to a biosimilar in a hypothetical drug switch.
METHODS


Ninety-six patients with rheumatic diseases taking an originator biologic were randomized to receive 1 of 4 biosimilar explanations: positive framing with and without an analogy, and negative framing with and without an analogy. Willingness to switch to a biosimilar, perceptions about biosimilars, and the effectiveness of the explanation were measured after the information delivery.
RESULTS


Positive framing led to more participants being willing to switch (67%) than negative framing (46%). Framing significantly predicted willingness to switch to a biosimilar, with participants in the positive framing group being 2.36 times more willing to switch (P = 0.041). The positive framing group also reported significantly greater perceived efficacy of biosimilars (P = 0.046) and thought the explanation was more convincing (P = 0.030). The analogy did not enhance willingness to switch or increase understanding (P > 0.05).
CONCLUSION


Positive framing can improve perceptions of and willingness to switch to a biosimilar in patients currently taking biologic treatments.",2020,"The positive framing group also reported significantly greater perceived efficacy of biosimilars (P = 0.046), and thought the explanation was more convincing (P = 0.030).",['Ninety-six patients with rheumatic diseases taking an originator biologic'],"['biosimilar explanations - positive framing with and without an analogy, and negative framing with and without an analogy']",['efficacy of biosimilars'],"[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}]",96.0,0.0527785,"The positive framing group also reported significantly greater perceived efficacy of biosimilars (P = 0.046), and thought the explanation was more convincing (P = 0.030).","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Gasteiger', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Annie S K', 'Initials': 'ASK', 'LastName': 'Jones', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kleinstäuber', 'Affiliation': 'University of Auckland, Auckland, and University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lobo', 'Affiliation': 'Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Horne', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': 'Auckland District Health Board and University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Petrie', 'Affiliation': 'University of Auckland, Auckland, New Zealand.'}]",Arthritis care & research,['10.1002/acr.24012']
603,31233281,Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate.,"OBJECTIVE


To evaluate the long-term efficacy and safety of maintaining baricitinib monotherapy in patients with active rheumatoid arthritis (RA) originally treated with baricitinib monotherapy or switched from methotrexate (MTX) or the combination of baricitinib plus MTX to baricitinib monotherapy.
METHODS


This is a post hoc analysis of patients from the RA-BEGIN study who entered a long-term extension, RA-BEYOND, and were assessed for up to 24 weeks. In RA-BEGIN, MTX-naive patients with early active RA were randomized to MTX monotherapy, baricitinib 4 mg monotherapy, or baricitinib 4 mg plus MTX. At week 52, all patients entering RA-BEYOND received baricitinib 4 mg monotherapy. MTX could be prescribed during RA-BEYOND at the investigator's discretion.
RESULTS


Patients in RA-BEYOND who were not rescued in RA-BEGIN (n = 423) were evaluated. Of these, 47% continued baricitinib monotherapy and 53% added MTX, with similar proportions from the 3 original arms. Patients with lower disease activity at the RA-BEYOND baseline generally continued to do well with baricitinib monotherapy as assessed by the Simplified Disease Activity Index, the Clinical Disease Activity Index, and the Health Assessment Questionnaire disability index scores. Patients prescribed MTX had higher disease activity at the RA-BEYOND baseline and had improved disease activity after the addition of MTX. Safety outcomes were similar across treatment groups.
CONCLUSION


Many patients responded well to continued baricitinib monotherapy or to switching to baricitinib monotherapy from MTX monotherapy or baricitinib plus MTX, showing sustained or improved disease control. The groups of patients who had less disease control on their original therapies showed sustained or improved disease control with the addition of MTX to baricitinib.",2020,"Safety outcomes were similar across treatment groups.
","['rheumatoid arthritis', 'naïve patients with early active RA', 'patients with active rheumatoid arthritis (RA']","['MTX monotherapy or baricitinib plus MTX', 'MTX monotherapy, baricitinib 4-mg monotherapy, or baricitinib 4-mg plus MTX', 'MTX', 'baricitinib plus MTX', 'baricitinib 4-mg monotherapy', 'baricitinib monotherapy or switched from methotrexate (MTX', 'baricitinib monotherapy', 'long-term baricitinib with and without methotrexate', 'methotrexate monotherapy or baricitinib plus methotrexate']","['Safety outcomes', 'sustained or improved disease control', 'Simplified Disease Activity Index, Clinical Disease Activity Index, and Health Assessment Questionnaire-Disability Index scores', 'Efficacy and safety', 'disease activity']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",423.0,0.0574468,"Safety outcomes were similar across treatment groups.
","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schiff', 'Affiliation': 'University of Colorado, Denver.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Schlichting', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Issa', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Ivaylo', 'Initials': 'I', 'LastName': 'Stoykov', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lisse', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Pindaro', 'Initials': 'P', 'LastName': 'Martinez-Osuna', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Rooney', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Cristiano A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'Centro Paulista de Investigação Clinica, São Paulo, Brazil.'}]",Arthritis care & research,['10.1002/acr.24007']
604,31230988,Baseline characteristics did not identify people with low back pain who respond best to a Movement System Impairment-Based classification treatment.,"STUDY DESIGN


Secondary analysis of data from a randomized controlled trial.
BACKGROUND


Treatment based on the Movement System Impairment-Based classification for chronic low back pain results in the same benefit when compared to other forms of exercise. It is possible that participant's characteristics measured at baseline can identify people with chronic low back pain who would respond best to a treatment based on the Movement System Impairment model.
OBJECTIVES


To assess if specific characteristics of people with chronic low back pain measured at baseline can modify the effects of a treatment based on the Movement System Impairment model on pain and disability.
METHODS


Four variables assessed at baseline that could potentially modify the treatment effects of the treatment based on the Movement System Impairment model were selected (age, educational status, physical activity status and STarT back tool classification). Separate univariate models were used to investigate a possible modifier treatment effect of baseline participant's characteristics on pain and disability after the treatment. Findings of interaction values above 1 point for the outcome mean pain intensity or above 3 points for disability (Roland Morris questionnaire) were considered clinically relevant.
RESULTS


Linear regression analyses for the outcomes of pain and disability did not show interaction values considered clinically relevant for age, educational status, physical activity status and STarT back tool classification.
CONCLUSION


Age, educational status, physical activity status and STarT back tool classification did not modify the effects of an 8-week treatment based on the Movement System Impairment model in patients with chronic low back pain. Registered at www.clinicaltrials.gov: NCT02221609 (https://clinicaltrials.gov/ct2/show/NCT02221609).",2020,"RESULTS


Linear regression analyses for the outcomes of pain and disability did not show interaction values considered clinically relevant for age, educational status, physical activity status and STarT back tool classification.
","['patients with chronic low back pain', 'people with chronic low back pain']",[],"['educational status, physical activity status and STarT back tool classification', 'pain and disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]",[],"[{'cui': 'C0013658', 'cui_str': 'Educational Achievement'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",,0.151896,"RESULTS


Linear regression analyses for the outcomes of pain and disability did not show interaction values considered clinically relevant for age, educational status, physical activity status and STarT back tool classification.
","[{'ForeName': 'Daniel Camara', 'Initials': 'DC', 'LastName': 'Azevedo', 'Affiliation': 'Programa de Mestrado e Doutorado em Fisioterapia, Universidade Cidade de São Paulo, São Paulo, SP, Brazil; Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: danielazevedo@pucminas.br.'}, {'ForeName': 'Paulo Henrique', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Henrique de Oliveira', 'Initials': 'HO', 'LastName': 'Santos', 'Affiliation': 'Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Daniel Ribeiro', 'Initials': 'DR', 'LastName': 'Oliveira', 'Affiliation': 'Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Joao Victor Leite de', 'Initials': 'JVL', 'LastName': 'Souza', 'Affiliation': 'Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Leonardo Oliveira Pena', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': 'Programa de Mestrado e Doutorado em Fisioterapia, Universidade Cidade de São Paulo, São Paulo, SP, Brazil; Musculoskeletal Division, The George Institute for Global Health, Sydney, NSW, Australia.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.05.006']
605,31520608,A factorial-design randomized controlled trial comparing misoprostol alone to Dilapan with misoprostol and comparing buccal to vaginal misoprostol for same-day cervical preparation prior to dilation & evacuation at 14 weeks 0 days-19 weeks 6 days gestation .,"OBJECTIVES


To compare procedure times following same-day cervical preparation using misoprostol 400 mcg alone or misoprostol 400 mcg plus hygroscopic dilators for dilation and evacuation (D&E) before 20 weeks gestation and to compare side effects of buccal and vaginal misoprostol administration.
STUDY DESIGN


We randomized women undergoing D&E at 14 weeks 0 days-19 weeks 6 days gestation to receive (1) hygroscopic dilators or not and (2) buccal or vaginal misoprostol using a 2 × 2 factorial design. We assessed two primary outcomes: (1) total procedure time, defined as time to insert hygroscopic dilators plus D&E time, and (2) side effects of misoprostol 4-6 h after initiation of cervical preparation using a 5-point Likert scale assessing nausea, emesis, diarrhea, chills and cramps.
RESULTS


We randomized 163 women and 161 completed the study. We completed all procedures in one day. Mean total procedure time was 14.0 and 10.8 min. with and without hygroscopic dilators (difference 3.2 minutes, 95% CI 1.7, 4.6). Mean D&E procedure time was 0.7 (95% CI -0.8, 2.1) min longer without hygroscopic dilators. Initial cervical dilation was 15.6 and 11.7 mm with and without hygroscopic dilators (difference 3.9 mm, 95% CI 3.1, 4.8). Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p = 0.04.
CONCLUSIONS


Hygroscopic dilators with misoprostol requires more time and increases cervical dilation without shortening D&E time when used for cervical preparation 4-6 h prior to D&E before 20 weeks. Women receiving vaginal misoprostol may have more chills compared to buccal misoprostol.
IMPLICATIONS


Adding hygroscopic dilators to misoprostol for same day D&E procedures at less than 20 weeks gestation increases total intervention time without reducing D&E time and is less favored by patients. Clinical judgment requires balancing relative effectiveness with patient preference. Further studies should evaluate the side effect profile of vaginal misoprostol.",2019,"Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p=.04.
","['women undergoing D&E at 14weeks 0days', '163 women and 161 completed the study', 'same-day cervical preparation prior to Dilation & Evacuation at 14weeks 0days to 19weeks 6days gestation']","['misoprostol 400 mcg alone or misoprostol 400 mcg plus hygroscopic dilators', 'buccal misoprostol', 'misoprostol', 'hygroscopic dilators or not and (2) buccal or vaginal misoprostol', 'vaginal misoprostol', 'Dilapan with misoprostol and comparing buccal to vaginal misoprostol']","['total intervention time', 'Initial cervical dilation', 'chills', 'Mean D&E procedure time', 'Mean total procedure time', 'total procedure time, defined as time to insert hygroscopic dilators plus D&E time, and (2) side effects of misoprostol 4-6h after initiation of cervical preparation using a 5-point Likert scale assessing nausea, emesis, diarrhea, chills and cramps']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0174425', 'cui_str': 'dilapan'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1446787', 'cui_str': 'Cramping'}]",163.0,0.384578,"Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p=.04.
","[{'ForeName': 'Jamilah M', 'Initials': 'JM', 'LastName': 'Shakir-Reese', 'Affiliation': 'MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010, USA. Electronic address: jmshakir@gmail.com.'}, {'ForeName': 'Peggy P', 'Initials': 'PP', 'LastName': 'Ye', 'Affiliation': 'MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010, USA.'}, {'ForeName': 'Jamila B', 'Initials': 'JB', 'LastName': 'Perritt', 'Affiliation': 'Planned Parenthood of Metropolitan Washington, DC, 1225 4th. St., NE, Washington, DC 20002, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Lotke', 'Affiliation': 'MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010, USA; Georgetown University School of Medicine, 4000 Reservoir Rd NW, 120 Building D, Washington, DC 20007, USA.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Reeves', 'Affiliation': 'MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010, USA; DuPont Clinic, 1120 19th St. NW, Suite 316, Washington, DC 20036, USA; Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St. Baltimore, MD 21205, USA.'}]",Contraception,['10.1016/j.contraception.2019.09.001']
606,31232166,'No one ever asked us': a feasibility study assessing the co-creation of a physical activity programme with adolescent girls.,"BACKGROUND


Globally, the poor activity level of adolescent girls is a public health concern. Little research has involved adolescents in the design of interventions. This study assessed the feasibility of involving girls in the co-creation of an activity programme.
METHODS


Thirty-one students (15-17 years old) were recruited from a post-primary school. The Behaviour Change Wheel guided intervention design, providing insights into participants' capability, opportunity and motivation for change. Step counts and self-reported physical activity levels were recorded pre- and post-intervention. Feasibility benchmarks assessed recruitment, data collection, acceptability and adherence.
RESULTS


Activity and educational sessions were delivered for six weeks during physical education class. Average attendance was 87% (benchmark = 80%). Eligibility was 61% (benchmark = 60%). There was a 100% retention rate (benchmark = 90%). All participants ( n  = 31) completed baseline measures and 71% ( n  = 22) completed post-measures. 54% ( n  = 17) of students completed pedometer measurements, with 32% ( n  = 10) having complete data. Average daily steps were 13,121 pre-intervention and 14,128 post-intervention ( p  > 0.05). Data collection was feasible, receiving a mean score > 4/5 (benchmark > 3.5/5).
CONCLUSIONS


The Behaviour Change Wheel can be used to co-create an activity programme with adolescent girls. Predetermined benchmarks, except for pedometer recordings, were reached or exceeded, providing evidence for the need of a randomised controlled trial to test effectiveness.",2020,"Average daily steps were 13,121 pre-intervention and 14,128 post-intervention ( p  > 0.05).","['adolescent girls', 'Thirty-one students (15-17 years old) were recruited from a post-primary school']",['physical activity programme'],"['Feasibility benchmarks assessed recruitment, data collection, acceptability and adherence', 'Average attendance', 'Step counts and self-reported physical activity levels', 'retention rate', 'Average daily steps']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.0464856,"Average daily steps were 13,121 pre-intervention and 14,128 post-intervention ( p  > 0.05).","[{'ForeName': 'Méabh', 'Initials': 'M', 'LastName': 'Corr', 'Affiliation': 'Department of Arts Education and Physical Education, Mary Immaculate College, Limerick, Ireland.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Murtagh', 'Affiliation': 'Department of Arts Education and Physical Education, Mary Immaculate College, Limerick, Ireland.'}]",Global health promotion,['10.1177/1757975919853784']
607,31027892,"An open-label, randomized trial indicates that everolimus with tacrolimus or cyclosporine is comparable to standard immunosuppression in de novo kidney transplant patients.","This is a randomized trial (ATHENA study) in de novo kidney transplant patients to compare everolimus versus mycophenolic acid (MPA) with similar tacrolimus exposure in both groups, or everolimus with concomitant tacrolimus or cyclosporine (CsA), in an unselected population. In this 12-month, multicenter, open-label study, de novo kidney transplant recipients were randomized to everolimus with tacrolimus (EVR/TAC), everolimus with CsA (EVR/CsA) or MPA with tacrolimus (MPA/TAC), with similar tacrolimus exposure in both groups. Non-inferiority of the primary end point (estimated glomerular filtration rate [eGFR] at month 12), assessed in the per-protocol population of 338 patients, was not shown for EVR/TAC or EVR/CsA versus MPA/TAC. In 123 patients with TAC levels within the protocol-specified range, eGFR outcomes were comparable between groups. The mean increase in eGFR during months 1 to 12 post-transplant, analyzed post hoc, was similar with EVR/TAC or EVR/CsA versus MPA/TAC. The incidence of treatment failure (biopsy proven acute rejection, graft loss or death) was not significant for EVR/TAC but significant for EVR/CsA versus MPA/TAC. Most biopsy-proven acute rejection events in this study were graded mild (BANFF IA). There were no differences in proteinuria between groups. Cytomegalovirus and BK virus infection were significantly more frequent with MPA/TAC. Thus, everolimus with TAC or CsA showed comparable efficacy to MPA/TAC in de novo kidney transplant patients. Non-inferiority of renal function, when pre-specified, was not shown, but the mean increase in eGFR from month 1 to 12 was comparable to MPA/TAC.",2019,"The incidence of treatment failure (biopsy proven acute rejection, graft loss or death) was not significant for EVR/TAC but significant for EVR/CsA versus MPA/TAC.","['de novo kidney transplant patients', 'novo kidney transplant recipients', '123 patients with TAC levels', 'de\xa0novo kidney transplant patients']","['MPA/TAC', 'everolimus with tacrolimus or cyclosporine', 'everolimus with tacrolimus (EVR/TAC), everolimus with CsA (EVR/CsA) or MPA with tacrolimus (MPA/TAC', 'everolimus versus mycophenolic acid (MPA) with similar tacrolimus exposure', 'everolimus with concomitant tacrolimus or cyclosporine (CsA']","['glomerular filtration rate [eGFR', 'mean increase in eGFR', 'proteinuria', 'incidence of treatment failure (biopsy proven acute rejection, graft loss or death', 'eGFR', 'Cytomegalovirus and BK virus infection', 'renal function']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0162643'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C1096691', 'cui_str': 'BK virus infection'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",123.0,0.0269397,"The incidence of treatment failure (biopsy proven acute rejection, graft loss or death) was not significant for EVR/TAC but significant for EVR/CsA versus MPA/TAC.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sommerer', 'Affiliation': 'Nephrology Unit, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Suwelack', 'Affiliation': 'Department of Internal Medicine D, Transplant Nephrology, University Hospital of Münster, Münster, Germany.'}, {'ForeName': 'Duska', 'Initials': 'D', 'LastName': 'Dragun', 'Affiliation': 'Department of Nephrology and Intensive Care Medicine, Charité Universtätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schenker', 'Affiliation': 'Department of Surgery, University Hospital Knappschaftskrankenhaus Bochum, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Hauser', 'Affiliation': 'Department of Nephrology, Goethe University Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Witzke', 'Affiliation': 'Department of Infectious Diseases, University Duisburg-Essen, Essen, Germany; Department of Nephrology, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hugo', 'Affiliation': 'University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Merville', 'Affiliation': 'Department of Nephrology-Transplantation-Dialysis-Apheresis, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Junge', 'Affiliation': 'Novartis Pharma GmbH, Nuernberg, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Thaiss', 'Affiliation': 'III. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Nashan', 'Affiliation': 'Department of Hepatobiliary Surgery and Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: bjoern.nashan@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2019.01.041']
608,32409982,"A Phase 1, Randomised, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers.","BACKGROUND


There is increasing interest in the use of purified cannabidiol (CBD) as a treatment for a wide range of conditions due to its reported anti-inflammatory, anxiolytic, antiemetic and anticonvulsant properties.
OBJECTIVE


The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single ascending dose of a new lipid-based oral formulation of CBD in healthy volunteers after a high-fat meal.
METHODS


A total of 24 eligible healthy volunteers (aged 18-48 years) were randomised to one of three sequential cohorts (each with six active  and two placebo subjects). Cohort 1 received 5 mg/kg CBD or placebo, cohort 2 received 10 mg/kg CBD or placebo (cohort 2), and cohort 3 received 20 mg/kg CBD or placebo. Data relating to adverse events, vital signs, clinical laboratory assessments, 12-lead ECGs, physical examinations and concomitant medications were collected to assess safety and tolerability. Blood samples were collected up to 8 days postdose and plasma was analysed by liquid chromatography and mass spectrometry to assess the pharmacokinetics of the CBD formulation.
RESULTS


CBD was well tolerated in the healthy volunteers (mean age: 24.0 years) treated with a single oral dose of CBD. There were no safety concerns with increasing the dose and the safety profiles of the CBD-treated and placebo-treated subjects were similar. The most frequently reported treatment emergent adverse events (TEAEs) were headache (17%) and diarrhoea (8%). There were no reported serious adverse events (SAEs) and no clinical laboratory findings, vital signs, ECGs or physical examination findings that were reported as TEAEs or were of clinical significance during the study. After a high-fat meal, CBD was detected in plasma samples at 15 min postdose; the median time to maximum plasma concentration (T max ) was 4 h across all three CBD dose cohorts. The CBD plasma exposure [maximum observed plasma concentration (C max ) and the area under the concentration-time curve (AUC)] increased in a dose-proportional manner and declined to levels approaching the lower level of quantification by day 8. The terminal elimination half-life was approximately 70 h, suggesting that 2-3 weeks are needed to fully eliminate CBD.
CONCLUSIONS


This new CBD formulation demonstrated a favourable safety and tolerability profile in healthy volunteers that was consistent with the profiles reported for other purified CBD products. No severe or serious AEs were observed in this study and there were no safety concerns.
TRIAL REGISTRATION


ACTRN12618001424291. Registered August 2018.",2020,There were no safety concerns with increasing the dose and the safety profiles of the CBD-treated and placebo-treated subjects were similar.,"['Fed Healthy Volunteers', 'healthy volunteers', 'healthy volunteers (mean age: 24.0\xa0years', '24 eligible healthy volunteers (aged 18-48\xa0years', 'healthy volunteers after a high-fat meal']","['new lipid-based oral formulation of CBD', 'Placebo', '10\xa0mg/kg CBD or placebo', '5\xa0mg/kg CBD or placebo', '20\xa0mg/kg CBD or placebo', 'purified cannabidiol (CBD', 'placebo']","['headache', 'Safety, Tolerability and Pharmacokinetics of Cannabidiol', 'safety profiles', 'adverse events, vital signs, clinical laboratory assessments, 12-lead ECGs, physical examinations and concomitant medications', 'tolerated', 'safety, tolerability and pharmacokinetics', 'median time to maximum plasma concentration (T max ', 'safety and tolerability', 'diarrhoea', 'severe or serious AEs', 'safety and tolerability profile', 'serious adverse events (SAEs) and no clinical laboratory findings, vital signs, ECGs or physical examination findings', 'CBD plasma exposure [maximum observed plasma concentration (C max ) and the area under the concentration-time curve (AUC']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",24.0,0.234806,There were no safety concerns with increasing the dose and the safety profiles of the CBD-treated and placebo-treated subjects were similar.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Perkins', 'Affiliation': 'Department of Health and Human Services, Office of Medicinal Cannabis, 50 Lonsdale St, Melbourne, VIC, 3000, Australia. daniel.perkins@dhhs.vic.gov.au.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Health and Human Services, Office of Medicinal Cannabis, 50 Lonsdale St, Melbourne, VIC, 3000, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ong', 'Affiliation': 'Department of Health and Human Services, Office of Medicinal Cannabis, 50 Lonsdale St, Melbourne, VIC, 3000, Australia.'}, {'ForeName': 'Tri-Hung', 'Initials': 'TH', 'LastName': 'Nguyen', 'Affiliation': 'Medicines Manufacturing Innovation Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cox', 'Affiliation': 'Neuroscience Trials Australia, Heidelberg, VIC, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Francis', 'Affiliation': 'Avance Clinical, Thebarton, SA, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Mcintosh', 'Affiliation': 'Medicines Manufacturing Innovation Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lilley', 'Affiliation': ""Royal Children's Hospital, Parkville, VIC, Australia.""}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00624-6']
609,31943605,Comparison of three-dimensional and 4K imaging systems in novice surgeons: a cross-over study.,"BACKGROUND


Laparoscopy has revolutionized the surgical field with the advent of minimally invasive techniques leading to smaller surgical wounds, enhanced recovery, early discharge from the hospital and early return to work. Since the initiation of three-dimensional (3D) systems, studies have failed to prove significant advantages over traditional two-dimensional systems which could be attributed to suboptimal image quality, poor illumination and high cost of earlier systems. Recent advances in stereoscopy have led to the introduction of high-definition (HD) systems with improvement in image quality in both two-dimensional and 3D systems. With HD and new 4K imaging system, the previous data are now obsolete.
METHODS


We devised a cross-over study using the Olympus 4K camera imaging system compared with the HD 3D systems using 40 novice surgeons with no prior surgical skills to perform standardized surgical tasks and the groups were crossed over to assess any difference in the learning curve with the imaging systems.
RESULTS


The data showed a statistically significant difference in errors performed with the 3D imaging system with reduction in errors for passing needle through a ring, knot tying, cutting circle and touching circles with a needle. The time taken to perform those tasks was comparable except in knot tying where there was significant reduction in the time taken to tie knots with a P-value of <0.001 in both groups.
CONCLUSION


The study showed no significant difference in the time to perform tasks. The precision of the tasks was significantly improved with the 3D systems.",2020,"The data showed a statistically significant difference in errors performed with the 3D imaging system with reduction in errors for passing needle through a ring, knot tying, cutting circle and touching circles with a needle.","['40 novice surgeons with no prior surgical skills', 'novice surgeons']",[],"['time to perform tasks', 'precision of the tasks']","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",40.0,0.0235963,"The data showed a statistically significant difference in errors performed with the 3D imaging system with reduction in errors for passing needle through a ring, knot tying, cutting circle and touching circles with a needle.","[{'ForeName': 'Abdullah Muhammad', 'Initials': 'AM', 'LastName': 'Rana', 'Affiliation': 'Department of Colorectal Surgery, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Abdul Ahad', 'Initials': 'AA', 'LastName': 'Rana', 'Affiliation': 'Department of Colorectal Surgery, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hewett', 'Affiliation': 'Department of Colorectal Surgery, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}]",ANZ journal of surgery,['10.1111/ans.15653']
610,30727881,"Metabolism of the Dual Orexin Receptor Antagonist ACT-541468, Based on Microtracer/ Accelerator Mass Spectrometry.","BACKGROUND


As part of an integrated and innovative approach to accelerate the clinical development of the dual receptor antagonist ACT-541468, 6 healthy subjects in one cohort in a first-in-humans (FIH) study received an oral dose of 50 mg non-labeled ACT-541468 together with a microtracer amount of 250 nCi of 14C-labeled ACT- 541468 to investigate its absorption, distribution, metabolism, and excretion (ADME).
METHODS


Using accelerator mass spectrometry (AMS), radiochromatograms were constructed for fractionated plasma, urine, and feces samples. Subsequently, the structures of the metabolites were elucidated using high performance liquid chromatography (HPLC) coupled with high resolution mass spectrometry.
RESULTS


In total 77 metabolites have been identified of which 30, 28, and 60 were present in plasma, urine, and feces, respectively. In plasma, the major metabolites were the mono-oxidized benzylic alcohol M3, the ACT-541468 aldehyde M1, formed by further oxidation of M3 in the benzylic position, and the doubly oxidized M10, formed by (1) benzylic oxidation of M3 (loss of one molecule of water and one molecule of ammonia) and (2) additional loss of water from the oxidized pyrrolidine ring of M5. Transformation of the pyrrolidine to a 6-membered ring was detected. Metabolites that accounted for more than 5% of total radioactivity in excreta were M2, which is also formed by oxidation at the benzylic position, M4, formed by demethylation of the methoxy-group, M7 and A6, both formed by oxidation of M4, and M10, the only major metabolite detected in urine.
CONCLUSION


In conclusion, ACT-541468 is extensively metabolized predominantly by oxidative transformations.",2019,"In plasma, the major metabolites were the mono-oxidized benzylic alcohol M3, the ACT-541468 aldehyde M1, formed by further oxidation of M3 in the benzylic position, and the doubly oxidized M10, formed by (1) benzylic oxidation of M3 (loss of one molecule of water and one molecule of ammonia) and (2) additional loss of water from the oxidized pyrrolidine ring of M5.",['6 healthy subjects in one cohort in a first-in-humans (FIH'],[],[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],[],77.0,0.0267743,"In plasma, the major metabolites were the mono-oxidized benzylic alcohol M3, the ACT-541468 aldehyde M1, formed by further oxidation of M3 in the benzylic position, and the doubly oxidized M10, formed by (1) benzylic oxidation of M3 (loss of one molecule of water and one molecule of ammonia) and (2) additional loss of water from the oxidized pyrrolidine ring of M5.","[{'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Muehlan', 'Affiliation': 'Idorsia Pharmaceuticals Ltd., Hegenheimermattweg 91, 4123 Allschwil, Switzerland.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Fischer', 'Affiliation': 'Labor fur Analytik und Metabolismusforschung Service GmbH, Kopernikusstrasse 25, 50126 Bergheim, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Zimmer', 'Affiliation': 'Zimmer Bioanalytics & More, St. Alban Ring 282, 4052 Basel, Switzerland.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Aissaoui', 'Affiliation': 'Idorsia Pharmaceuticals Ltd., Hegenheimermattweg 91, 4123 Allschwil, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Grimont', 'Affiliation': 'Idorsia Pharmaceuticals Ltd., Hegenheimermattweg 91, 4123 Allschwil, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Boss', 'Affiliation': 'Idorsia Pharmaceuticals Ltd., Hegenheimermattweg 91, 4123 Allschwil, Switzerland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Croft', 'Affiliation': 'Xceleron, a Pharmaron Company, 20340 Seneca Meadows Parkway, Germantown, MD 20876, United States.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'van Gerven', 'Affiliation': 'Centre for Human Drug Research, Zernikedreef 8, 2333 CL Leiden, Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Krähenbühl', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Clinical Research, University Hospital of Basel, 4031 Basel, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Idorsia Pharmaceuticals Ltd., Hegenheimermattweg 91, 4123 Allschwil, Switzerland.'}]",Current drug metabolism,['10.2174/1389200220666190206141814']
611,32410404,"Human Recombinant Apyrase Therapy Protects Against Myocardial Ischemia/Reperfusion Injury and Preserves Left Ventricular Systolic Function in Rats, as Evaluated by 7T Cardiovascular Magnetic Resonance Imaging.","OBJECTIVE


The occurrence of intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO) in myocardial infarction (MI), known as severe ischemia/reperfusion injury (IRI), has been associated with adverse remodeling. APT102, a soluble human recombinant ecto-nucleoside triphosphate diphosphohydrolase-1, can hydrolyze extracellular nucleotides to attenuate their prothrombotic and proinflammatory effects. The purpose of this study was to temporally evaluate the therapeutic effect of APT102 on IRI in rats and to elucidate the evolution of IRI in the acute stage using cardiovascular magnetic resonance imaging (CMRI).
MATERIALS AND METHODS


Fifty-four rats with MI, induced by ligation of the origin of the left anterior descending coronary artery for 60 minutes, were randomly divided into the APT102 (n = 27) or control (n = 27) group. Intravenous infusion of APT102 (0.3 mg/kg) or placebo was administered 15 minutes before reperfusion, and then 24 hours, 48 hours, 72 hours, and on day 4 after reperfusion. CMRI was performed at 24 hours, 48 hours, 72 hours, and on day 5 post-reperfusion using a 7T system and the hearts were collected for histopathological examination. Cardiac function was quantified using cine imaging and IMH/edema using T2 mapping, and infarct/MVO using late gadolinium enhancement.
RESULTS


The extent of infarction ( p  < 0.001), edema ( p  < 0.001), IMH ( p  = 0.013), and MVO ( p  = 0.049) was less severe in the APT102 group than in the control group. IMH size at 48 hours was significantly greater than that at 24 hours, 72 hours, and 5 days after reperfusion (all  p  < 0.001). The left ventricular ejection fraction (LVEF) was significantly greater in the APT102 group than in the control group ( p  = 0.006). There was a negative correlation between LVEF and IMH ( r  = -0.294,  p  = 0.010) and a positive correlation between IMH and MVO ( r  = 0.392,  p  < 0.001).
CONCLUSION


APT102 can significantly alleviate damage to the ischemic myocardium and microvasculature. IMH size peaked at 48 hours post reperfusion and IMH is a downstream consequence of MVO. IMH may be a potential therapeutic target to prevent adverse remodeling in MI.",2020,"IMH size at 48 hours was significantly greater than that at 24 hours, 72 hours, and 5 days after reperfusion (all  p  < 0.001).","['Fifty-four rats with MI, induced by ligation of the origin of the left anterior descending coronary artery for 60 minutes']","['IMH', 'APT102', 'Human Recombinant Apyrase Therapy', 'placebo']","['intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO', 'Cardiac function', 'LVEF and IMH', 'edema', 'IMH', 'Left Ventricular Systolic Function', 'MVO', 'left ventricular ejection fraction (LVEF', 'IMH size']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0003652', 'cui_str': 'Apyrase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",54.0,0.0676234,"IMH size at 48 hours was significantly greater than that at 24 hours, 72 hours, and 5 days after reperfusion (all  p  < 0.001).","[{'ForeName': 'Ziqian', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, The First Affiliated Hospital of Kunming Medical College, Kunming, China.'}, {'ForeName': 'Ruzhi', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ridong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'APT Therapeutics Inc., St Louis, MO, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Fabao', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, Chengdu, China. gaofabao@wchscu.cn.'}]",Korean journal of radiology,['10.3348/kjr.2019.0853']
612,31207146,"Implementation study reporting diagnostic accuracy, outcomes and costs in a multicentre randomised controlled trial of non-expert lung ultrasound to detect pulmonary oedema.","BACKGROUND


Lung ultrasound experts claim that 'B line' artefacts herald pulmonary oedema, but links between early recognition and improved outcome are unconfirmed, particularly for non-expert clinicians.
OBJECTIVE


Assess individual and system impacts of early, non-expert lung ultrasound (LUS) in breathless older patients.
METHODS


Prospective single-blinded randomised controlled trial of point of care LUS by non-expert clinicians, augmenting ED assessment of patients over 60 years, presenting with dyspnoea. After brief training, clinicians at three hospitals used computer-generated block randomisation envelopes to allocate a convenience sample of consenting presenters to conventional or LUS-augmented management. ED provisional diagnosis was compared to a post-discharge chart audit diagnosis, blinded to ultrasound findings. Secondary outcomes were the length of stay in ED and hospital, costs and discharge destinations.
RESULTS


From three sites, 224 controls were compared with 218 interventions. LUS improved diagnostic accuracy, with a small effect size in favour of LUS (risk difference: 6.5%, 95% CI 0.9-12) and a number needed to scan of 16 (95% CI 8-107). With LUS, ED and hospital stay increased non-significantly, while discharge destination trends improved. No harm ensued.
CONCLUSIONS


Non-expert LUS augmenting dyspnoea workup may improve diagnostic accuracy, but did not significantly alter costs or outcomes in the ED or the hospital.
TRIAL REGISTRATION


Australia and New Zealand Clinical Trials Registry (ACTRN12613001023741).",2020,"LUS improved diagnostic accuracy, with a small effect size in favour of LUS (risk difference: 6.5%, 95% CI 0.9-12) and a number needed to scan of 16 (95% CI 8-107).","['breathless older patients', 'patients over 60\u2009years, presenting with dyspnoea']","['care LUS', 'non-expert lung ultrasound', 'non-expert lung ultrasound (LUS']","['diagnostic accuracy', 'length of stay in ED and hospital, costs and discharge destinations', 'LUS, ED and hospital stay']","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",224.0,0.196508,"LUS improved diagnostic accuracy, with a small effect size in favour of LUS (risk difference: 6.5%, 95% CI 0.9-12) and a number needed to scan of 16 (95% CI 8-107).","[{'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'Department of Emergency Medicine, Ipswich General Hospital, Ipswich, Queensland, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Brierley', 'Affiliation': 'Department of Emergency Medicine, Ipswich General Hospital, Ipswich, Queensland, Australia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Kinnear', 'Affiliation': 'Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Isoardi', 'Affiliation': 'Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Livesay', 'Affiliation': 'Department of Emergency Medicine, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Stieler', 'Affiliation': 'Department of Radiology, Ipswich General Hospital, Ipswich, Queensland, Australia.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Mitchell', 'Affiliation': 'Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}]",Emergency medicine Australasia : EMA,['10.1111/1742-6723.13333']
613,31780640,Imaginal retraining decreases craving for high-calorie food in overweight and obese women: A randomized controlled trial.,"Overweight and obesity are epidemic conditions. Obesity is associated with somatic and psychological sequelae, including serious life-shortening disorders (e.g., diabetes). This study aimed to evaluate the efficacy of a newly developed imaginal variant of approach bias modification (i.e., imaginal retraining) for the reduction of craving for high-calorie food. In a randomized controlled trial, 384 women with a body mass index above 25 were allocated to a wait-list control group or to two variants of imaginal retraining (ratio: 1; 0.5; 0.5). The two intervention groups were sent a manual on imaginal retraining. One group was explicitly encouraged and instructed to use electronic reminders (R ER ); the standard retraining group (R S ) was not encouraged to use electronic reminders. Assessments were 6 weeks apart and were carried out online. Craving for high-calorie food represented the primary outcome (based on the Visual Analog Scale, VAS). Secondary outcomes included the Food Cravings Questionnaire (FCQ-T-R). The study was registered as DRKS00017220. Women in the R ER  group utilized the retraining technique more often than those in the R S  condition, and utilization frequency in turn was associated with improvement on craving and eating behavior scales. Both intention-to-treat and per-protocol analyses showed a favorable effect of the R ER  group, which achieved significance on the primary outcome, as well as on several other outcomes relative to controls at a small to medium effect size. For those participants who measured their weight before and after the assessment using a scale, weight loss in the R ER  group was significantly greater compared to the control group. Both retraining groups (R ER : 39.4%; R S : 31.1%) reduced their subjective amount of eating relative to controls (24.2%). Approximately two-thirds of the sample (68.3%) performed the exercises at least once during the study period. The present results show that, when used regularly, imaginal retraining may reduce craving for high-calorie food in overweight and obese women. Of note, there was also evidence suggestive of weight reduction, although no diet or lifestyle change was recommended in the manual. Because a large subgroup neither read the manual nor performed the exercises, we recommend that future imaginal retraining be conveyed via short video clips.",2019,"Women in the R ER  group utilized the retraining technique more often than those in the R S  condition, and utilization frequency in turn was associated with improvement on craving and eating behavior scales.","['384 women with a body mass index above 25', 'overweight and obese women']","['Imaginal retraining', 'wait-list control group or to two variants of imaginal retraining', 'electronic reminders (R ER ); the standard retraining group (R S ) was not encouraged to use electronic reminders', 'manual on imaginal retraining']","['subjective amount of eating relative', 'craving and eating behavior scales', 'Food Cravings Questionnaire (FCQ-T-R', 'weight loss', 'Visual Analog Scale, VAS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0222045'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",384.0,0.0639822,"Women in the R ER  group utilized the retraining technique more often than those in the R S  condition, and utilization frequency in turn was associated with improvement on craving and eating behavior scales.","[{'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. moritz@uke.uni-hamburg.de.'}, {'ForeName': 'Anja S', 'Initials': 'AS', 'LastName': 'Göritz', 'Affiliation': 'Department of Occupational and Consumer Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Schmotz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Weierstall-Pust', 'Affiliation': 'MSH Medical School Hamburg, University of Applied Sciences and Medical University, Hamburg, Germany.'}, {'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Gehlenborg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gallinat', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Translational psychiatry,['10.1038/s41398-019-0655-7']
614,31759243,"Use of a flipped classroom in ophthalmology courses for nursing, dental and medical students: A quasi-experimental study using a mixed-methods approach.","BACKGROUND


Traditional teaching is associated with dilemmas, such as low motivation to learn and passive learning. In contrast, use of a flipped classroom with the proper learning design has the potential to promote accelerated learning, bolster transmission of competencies (i.e., critical thinking, communication and problem-solving skills) and improve teamwork capacity, all of which are of great significance in professional healthcare practice, including nursing, dentistry and medicine.
OBJECTIVE


The aim of the study was to examine the effects of using a flipped classroom in ophthalmology courses for undergraduate nursing students, dental students and higher vocational medical students.
DESIGN


A quasi-experimental design was used with an intervention (n = 100) and a comparison group (n = 100), pre-/post-testing measures and a mixed-methods approach.
SETTING


A university in China.
PARTICIPANTS


A total of 200 students were included.
METHODS


Students' self-rated learning ability was measured before and after the courses, and skill exams were performed after the courses. In addition, interviews were conducted with the clinical medical students concerning their experiences of the flipped classroom.
RESULTS


Students' self-rated learning ability improved significantly more in the intervention than in the comparison group, for the total scale and the three factors 'learning goals', 'self-efficacy and social learning' and 'problem-solving'. Skill exam scores were statistically significantly better in the intervention than in the comparison group. On the whole, the clinical medicine students felt the flipped classroom had a positive impact and improved their learning ability as well as knowledge in ophthalmology.
CONCLUSIONS


Use of a flipped classroom for nursing, dental and clinical medical students in ophthalmology courses shows promising results in the form of students' skill exam scores and self-rated learning ability.",2020,"RESULTS


Students' self-rated learning ability improved significantly more in the intervention than in the comparison group, for the total scale and the three factors 'learning goals', 'self-efficacy and social learning' and 'problem-solving'.","['ophthalmology courses for nursing, dental and medical students', 'A university in China', 'Students', 'A total of 200 students were included', 'undergraduate nursing students, dental students and higher vocational medical students']","['flipped classroom', 'pre-/post-testing measures and a mixed-methods approach']","['self-rated learning ability', ""total scale and the three factors 'learning goals', 'self-efficacy and social learning' and 'problem-solving"", 'learning ability', 'Skill exam scores']","[{'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0038493', 'cui_str': 'Students, Dental'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0540654', 'cui_str': 'FLICE-Inhibitory Protein'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0233832', 'cui_str': 'Learning ability (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679082', 'cui_str': 'Social Learning'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.020873,"RESULTS


Students' self-rated learning ability improved significantly more in the intervention than in the comparison group, for the total scale and the three factors 'learning goals', 'self-efficacy and social learning' and 'problem-solving'.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Clinical Medicine Department, Medicine and Health College, Lishui University, Lishui, China. Electronic address: lsxyzhuli@lsu.edu.cn.'}, {'ForeName': 'Zhengmei', 'Initials': 'Z', 'LastName': 'Lian', 'Affiliation': 'Nursing Department, Medicine and Health College, Lishui University, Lishui, China.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Engström', 'Affiliation': 'Nursing Department, Medicine and Health College, Lishui University, Lishui, China; Faculty of Health and Occupational Studies, University of Gävle, Gävle, Sweden; Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden. Electronic address: Maria.Engstrom@hig.se.'}]",Nurse education today,['10.1016/j.nedt.2019.104262']
615,30824296,A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer.,"BACKGROUND


The European Randomized study of Screening for Prostate Cancer (ERSPC) has previously demonstrated that prostate-specific antigen (PSA) screening decreases prostate cancer (PCa) mortality.
OBJECTIVE


To determine whether PSA screening decreases PCa mortality for up to 16yr and to assess results following adjustment for nonparticipation and the number of screening rounds attended.
DESIGN, SETTING, AND PARTICIPANTS


This multicentre population-based randomised screening trial was conducted in eight European countries. Report includes 182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcome was PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended.
RESULTS AND LIMITATIONS


The rate ratio of PCa mortality was 0.80 (95% confidence interval [CI] 0.72-0.89, p<0.001) at 16yr. The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr. The number of men needed to be invited for screening to prevent one PCa death was 570 at 16yr compared with 742 at 13yr. The number needed to diagnose was reduced to 18 from 26 at 13yr. Men with PCa detected during the first round had a higher prevalence of PSA >20ng/ml (9.9% compared with 4.1% in the second round, p<0.001) and higher PCa mortality (hazard ratio=1.86, p<0.001) than those detected subsequently.
CONCLUSIONS


Findings corroborate earlier results that PSA screening significantly reduces PCa mortality, showing larger absolute benefit with longer follow-up and a reduction in excess incidence. Repeated screening may be important to reduce PCa mortality on a population level.
PATIENT SUMMARY


In this report, we looked at the outcomes from prostate cancer in a large European population. We found that repeated screening reduces the risk of dying from prostate cancer.",2019,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"['eight European countries', '182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry']",['PSA screening'],"['PCa mortality', 'rate ratio of PCa mortality', 'absolute PCa mortality', 'risk of dying from prostate cancer', 'PCa death', 'PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended', 'number needed to diagnose']","[{'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",,0.339695,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden. Electronic address: jonas.hugosson@gu.se.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'University of Tampere, Faculty of Medicine and Life Sciences, Tampere, Finland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zappa', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Nelen', 'Affiliation': 'Provinciaal Instituut voor Hygiëne, Antwerp, Belgium.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kwiatkowski', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland; Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Lujan', 'Affiliation': 'Urology Department, Hospital Infanta Cristina, Parla, Madrid, Spain.'}, {'ForeName': 'Sigrid V', 'Initials': 'SV', 'LastName': 'Carlsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden; Departments of Surgery (Urology Service) and Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Kirsi M', 'Initials': 'KM', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lilja', 'Affiliation': 'Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Department of Translational Medicine, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Denis', 'Affiliation': 'Europa Uomo, Oncology Centre Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Recker', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Donella', 'Initials': 'D', 'LastName': 'Puliti', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Arnauld', 'Initials': 'A', 'LastName': 'Villers', 'Affiliation': 'Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rebillard', 'Affiliation': 'Urology Department, Clinique Beau Soleil, Montpellier, France.'}, {'ForeName': 'Tuomas P', 'Initials': 'TP', 'LastName': 'Kilpeläinen', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ulf H', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Rebecka Arnsrud', 'Initials': 'RA', 'LastName': 'Godtman', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Stinesen Kollberg', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventative Medicine, Queen Mary University of London, Charterhouse Square, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Huber', 'Affiliation': 'Department of Laboratory Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Theodorus', 'Initials': 'T', 'LastName': 'van der Kwast', 'Affiliation': 'Laboratory Medicine Program, University Health Network, Toronto, Canada.'}, {'ForeName': 'Eveline A', 'Initials': 'EA', 'LastName': 'Heijnsdijk', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bangma', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'De Koning', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Fritz H', 'Initials': 'FH', 'LastName': 'Schröder', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Prostate Cancer Research Center, Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.02.009']
616,31222812,Happiness or hopelessness in late life: A cluster RCT of the 3L-Mind-Training programme among the institutionalized older people.,"AIM


To explore the effectiveness of a new mental health promotion activities programme by including the criterion variables of happiness and depressive mood.
DESIGN


A single-blinded, clustered, randomized and controlled trial.
METHOD


A list consisting of the names of elderly residents was provided by the senior social worker at a geriatric institution. The participants recruited for the study were living on one of four different floors that had separate and non-interfering spaces and having comparable disabilities. The researchers randomly assigned residents on two floors as members of the intervention group; the other residents were considered the control group. The intervention groups attended 6 weeks of the 3L-Mind-Training programme, whereas the control group only engaged in regular health promotion activities. The mini version of the Chinese Happiness Inventory was adapted to measure happiness. The Geriatric Depression Scale short-form was used to measure depression in older people. A generalized estimating equation was used to analyse the short-term and durative effects.
FINDINGS


The 126 residents included in the study were 65-97 years old, and 90% of the residents relied on wheelchairs. The intervention activities give significant immediate and durative effects both on subjective well-being enhancement and depressive mood relief. When evaluating the overall intervention activity, 93.8% of the aged residents indicated that this programme was helpful and allowed them to view life events positively.
CONCLUSION AND IMPACT


A well-planned mind-training programme could help elderly people reform their viewpoint and create a more fun and happy experience of ageing.
TRIAL REGISTRATION


Data were obtained from the project, initiated in 2014, which was funded by the Ministry of Science and Technology in Taiwan and was approved by the Institutional Review Board in Chung Shan Medical University (No. CS15009). The trial registration number of the study was No. ChiCTR1900021811.",2020,The intervention activities provided significant immediate and durative effects both on subjective well-being enhancement and depressive mood relief.,"['older people', 'institutionalized older people', 'older residents was provided by the senior social worker at a geriatric institution', '126 residents ranged in age from 65-97 years old and 90% of the residents relied on wheelchairs']","['3L-Mind-Training program, whereas the control group only engaged in regular health promotion activities', '3L-Mind-Training programme', 'new mental health promotion activities program']","['Happiness or hopelessness in late life', 'depressive mood relief']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043143', 'cui_str': 'Wheel Chairs'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]",,0.0347688,The intervention activities provided significant immediate and durative effects both on subjective well-being enhancement and depressive mood relief.,"[{'ForeName': 'Yi-Chen', 'Initials': 'YC', 'LastName': 'Chiang', 'Affiliation': 'State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, PR China.'}, {'ForeName': 'Chun-Yang', 'Initials': 'CY', 'LastName': 'Lee', 'Affiliation': 'School of International Business, Xiamen University Tan Kah Kee College, Zhangzhou, China.'}, {'ForeName': 'Shao-Chieh', 'Initials': 'SC', 'LastName': 'Hsueh', 'Affiliation': 'Institute of Economics, School of Economics, Wang Yanan Institute for Studies in Economics, Xiamen University, Xiamen, China.'}]",Journal of advanced nursing,['10.1111/jan.14104']
617,31212041,A randomized education trial of spaced versus massed instruction to improve acquisition and retention of paediatric resuscitation skills in emergency medical service (EMS) providers.,"AIM


Resuscitation courses are typically taught in a massed format despite existing evidence suggesting skill decay as soon as 3 months after training. Our study explored the impact of spaced versus massed instruction on acquisition and long-term retention of provider paediatric resuscitation skills.
METHODS


Providers were randomized to receive a paediatric resuscitation course in either a spaced (four weekly sessions) or massed format (two sequential days). Infant and adult chest compressions [CC], bag mask ventilation [BMV], and intraosseous insertion [IO] performance was measured using global rating scales.
RESULTS


Forty-eight participants completed the study protocol. Skill performance improved from baseline in both groups immediately following training. 3-months post-training the infant and adult CC scores remained significantly improved from baseline testing in both the massed and spaced groups; however, the infant BMV and IO scores remained significantly improved from baseline testing in the spaced: BMV (pre, 1.8 ± 0.7 vs post-3-months, 2.2 ± 7; P = 0.005) IO (pre, 2.5 ± 1 vs post-3-months, 3.1 ± 0.5; P = 0.04) but not in the massed groups: BMV (pre, 1.6 ± 0.5 vs post-3-months, 1.8 ± 0.5; P = 0.98) IO (pre, 2.6 ± 1.1 vs post-3-months, 2.7 ± 0.2; P = 0.98).
CONCLUSION


3-month retention of CC skills are similar regardless of training format; however, retention of other resuscitation skills may be better when taught in a spaced format.",2019,"3-months post-training the infant and adult CC scores remained significantly improved from baseline testing in both the massed and spaced groups; however, the infant BMV and IO scores remained significantly improved from baseline testing in the spaced: BMV (pre, 1.8 ± 0.7 vs post-3-months, 2.2 ± 7; P = 0.005) IO (pre, 2.5 ± 1 vs post-3-months, 3.1 ± 0.5; P = 0.04) but not in the massed groups: BMV (pre, 1.6 ± 0.5 vs post-3-months, 1.8 ± 0.5; P = 0.98) IO (pre, 2.6 ± 1.1 vs post-3-months, 2.7 ± 0.2; P = 0.98).
","['Providers', 'Forty-eight participants completed the study protocol', 'emergency medical service (EMS) providers']","['spaced versus massed instruction', 'bag mask ventilation [BMV']","['Skill performance', 'infant and adult CC scores', 'intraosseous insertion [IO] performance', 'global rating scales', 'infant BMV and IO scores']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services (qualifier value)'}]","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}]",48.0,0.0669281,"3-months post-training the infant and adult CC scores remained significantly improved from baseline testing in both the massed and spaced groups; however, the infant BMV and IO scores remained significantly improved from baseline testing in the spaced: BMV (pre, 1.8 ± 0.7 vs post-3-months, 2.2 ± 7; P = 0.005) IO (pre, 2.5 ± 1 vs post-3-months, 3.1 ± 0.5; P = 0.04) but not in the massed groups: BMV (pre, 1.6 ± 0.5 vs post-3-months, 1.8 ± 0.5; P = 0.98) IO (pre, 2.6 ± 1.1 vs post-3-months, 2.7 ± 0.2; P = 0.98).
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Patocka', 'Affiliation': 'Department of Emergency Medicine, Cumming School of Medicine, University of Calgary, Foothills Medical Centre, C-231 1403-29 St NW, Calgary, AB, T2N 2T9, Canada. Electronic address: Catherine.patocka@ucalgary.ca.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Cheng', 'Affiliation': ""Departments of Pediatrics and Emergency Medicine, Cumming School of Medicine, University of Calgary, Alberta Children's Hospital Research Institute, Alberta Children's Hospital, Room C4-200, 2888 Shaganappi Trail NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sibbald', 'Affiliation': 'McMaster University, 237 Barton St West, Hamilton, ON, L8L 2X2, Canada. Electronic address: sibbald@mcmaster.ca.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Duff', 'Affiliation': 'University of Alberta Faculty of Medicine and Dentistry, Division of Pediatric Critical Care (PICU), 4-524 Edmonton Health Clinic Academy, 11405-87th Avenue, Edmonton, AB, T6G1C9, Canada. Electronic address: jduff@ualberta.ca.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Lai', 'Affiliation': 'Department of Emergency Medicine, Cumming School of Medicine, University of Calgary, Foothills Medical Centre, C-231 1403-29 St NW, Calgary, AB, T2N 2T9, Canada. Electronic address: allai@ualberta.ca.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lee-Nobbee', 'Affiliation': 'Department of Emergency Medicine, Cumming School of Medicine, University of Calgary, Foothills Medical Centre, C-231 1403-29 St NW, Calgary, AB, T2N 2T9, Canada. Electronic address: patricia.lee1@ucalgary.ca.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Levin', 'Affiliation': ""Department of Paediatrics, Children's Hospital, 800 Commissioners Road East, Rm B1-437, London, ON, N6A 5W9, Canada. Electronic address: hmlevin@uwo.ca.""}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Varshney', 'Affiliation': ""University of Ottawa, Department of Pediatrics, Children's Hospital of Eastern Ontario, 401 Smyth Rd, Ottawa, ON, K1H 8L1, Canada. Electronic address: tvarshney@cheo.on.ca.""}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Department of Emergency Medicine, Cumming School of Medicine, University of Calgary, Foothills Medical Centre, C-231 1403-29 St NW, Calgary, AB, T2N 2T9, Canada. Electronic address: bryan.weber@ucalgary.ca.'}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Bhanji', 'Affiliation': ""McGill University, Department of Pediatric Critical Care and Emergency Medicine, Department of Pediatrics, Montreal Children's Hospital, 1001 Decarie Boulevard, Montreal, QC, H4A 3J1, Canada.""}]",Resuscitation,['10.1016/j.resuscitation.2019.06.010']
618,31218397,Dual-memory retrieval efficiency after practice: effects of strategy manipulations.,"The study investigated practice effects, instruction manipulations, and the associated cognitive architecture of dual-memory retrieval from a single cue. In two experiments, we tested predictions about the presence of learned parallelism in dual-memory retrieval within the framework of the set-cue bottleneck model. Both experiments included three experimental laboratory sessions and involved computerized assessments of dual-memory retrieval performance with strategy instruction manipulations. In Experiment 1, subjects were assigned to three distinct dual-task practice instruction groups: (1) a neutral instruction group without a specific direction on how to solve the task (i.e., neutral instruction), (2) an instruction to synchronize the responses (i.e., synchronize instruction), and (3) an instruction to use a sequential response style (i.e., immediate instruction). Results indicate that strategy instructions are able to effectively influence dual retrieval during practice. Mainly, the instruction to synchronize responses led to the presence of learned retrieval parallelism. Experiment 2 provided an assessment of the cognitive processing architecture of dual-memory retrieval. The results provide support for the presence of a structural bottleneck that cannot be eliminated by extensive practice and instruction manipulations. Further results are discussed with respect to the set-cue bottleneck model.",2020,"The study investigated practice effects, instruction manipulations, and the associated cognitive architecture of dual-memory retrieval from a single cue.",[],"['neutral instruction group without a specific direction on how to solve the task (i.e., neutral instruction), (2) an instruction to synchronize the responses (i.e., synchronize instruction), and (3) an instruction to use a sequential response style (i.e., immediate instruction']",[],[],"[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]",[],3.0,0.0126528,"The study investigated practice effects, instruction manipulations, and the associated cognitive architecture of dual-memory retrieval from a single cue.","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Heidemann', 'Affiliation': 'Medical School Hamburg, Hamburg, Germany. Franziska.Heidemann@ruhr-uni-bochum.de.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Rickard', 'Affiliation': 'University of California, San Diego, USA.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Schubert', 'Affiliation': 'Martin-Luther University Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Strobach', 'Affiliation': 'Medical School Hamburg, Hamburg, Germany.'}]",Psychological research,['10.1007/s00426-019-01217-y']
619,31221502,"Multiple-dose clinical pharmacology of ACT-541468, a novel dual orexin receptor antagonist, following repeated-dose morning and evening administration.","ACT-541468 is a dual orexin receptor antagonist with sleep-promoting effects in humans. Following entry-into-humans, its pharmacokinetics (PK) including dose-proportionality and accumulation, pharmacodynamics (PD), safety, and tolerability following multiple-ascending oral dose (MAD) administration in the morning, and next-day residual effects after repeated evening administration were investigated in a double-blind, placebo-controlled, randomized study. 31 healthy male and female subjects in 3 dose-groups (10, 25, and 75 mg) received study drug in the morning for 5 days (MAD part), and 20 healthy subjects received 25 mg in the evening for 1 week (evening part). PK, PD (saccadic peak velocity (SPV), adaptive tracking, body sway, Bond and Lader visual analogue scales (VAS), Karolinska Sleepiness Scale (KSS), VAS Bowdle for assessment of psychedelic effects), Digit Symbol Substitution Test (DSST), and Simple Reaction Time Test (SRTT), safety, and tolerability were assessed. ACT-541468 was absorbed with a median t max  of 1.0-2.0 h across the 3 dose groups. The geometric mean elimination half-life (t ½ ) on Day 5 was between 5.6 and 8.5 h, and the exposure (area under the curve (AUC)) showed dose proportionality. No accumulation and no influence of sex on the multiple-dose PK parameters of ACT-541468 was observed. No effects were observed at 10 mg. Administration of 25 and 75 mg during the day showed clear dose-dependent effects on the PD parameters, while next-day effects were absent after evening administration of 25 mg. The drug was safe and well tolerated. In conclusion, multiple-dose PK/PD of ACT-541468 were compatible with a drug designated to treat insomnia.",2019,"The geometric mean elimination half-life (t ½ ) on Day 5 was between 5.6 and 8.5 h, and the exposure (area under the curve (AUC)) showed dose proportionality.","['31 healthy male and female subjects in 3 dose-groups (10, 25, and 75\u202fmg) received study drug in the morning for 5 days (MAD part), and 20 healthy subjects']",[],"['safe and well tolerated', 'PD parameters', 'pharmacokinetics (PK) including dose-proportionality and accumulation, pharmacodynamics (PD), safety, and tolerability', 'PK, PD (saccadic peak velocity (SPV), adaptive tracking, body sway, Bond and Lader visual analogue scales (VAS), Karolinska Sleepiness Scale (KSS), VAS Bowdle for assessment of psychedelic effects), Digit Symbol Substitution Test (DSST), and Simple Reaction Time Test (SRTT), safety, and tolerability']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018533', 'cui_str': 'Psychedelic Agents'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",31.0,0.0809589,"The geometric mean elimination half-life (t ½ ) on Day 5 was between 5.6 and 8.5 h, and the exposure (area under the curve (AUC)) showed dose proportionality.","[{'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Muehlan', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123 Allschwil, Switzerland. Electronic address: clemens.muehlan@idorsia.com.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': 'Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, the Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Zuiker', 'Affiliation': 'Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, the Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'van Gerven', 'Affiliation': 'Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, the Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123 Allschwil, Switzerland.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.05.009']
620,31221565,"Pain Control after Intravitreal Injection Using Topical Nepafenac 0.3% or Pressure Patching: A Randomized, Placebo-Controlled Trial.","PURPOSE


Pain after an intravitreal injection (IVI) can last up to 7 days and negatively impacts the patient's experience, potentially reducing treatment compliance. We prospectively evaluated topical nepafenac 0.3% suspension and patching for the reduction of pain after IVI.
DESIGN


Randomized controlled trial.
PARTICIPANTS


Sixty patients receiving an IVI of bevacizumab, aflibercept, or triamcinolone acetonide in 1 eye.
METHODS


Participants were randomized equally to receive either a single drop of nepafenac 0.3%, a pressure patch for 2 hours, or a single drop of preservative-free artificial tears (control group). A single-blinded placebo-controlled design was used to mask the topical treatment used. Pain was assessed using the Numeric Pain Rating Scale that ranged from 0 to 10 (horizontal pain scale). Because pain scores were not normally distributed, statistical analysis was performed using a nonparametric randomization-based analysis of covariance.
MAIN OUTCOME MEASURE


Pain scores.
RESULTS


Fifty-six and 53 patients of the 60 patients enrolled completed the 6- and 24-hour follow-ups, respectively. Numeric Pain Rating Scale scores at 6 and 24 hours after IVI were lower in the nepafenac group (0.8±0.3 and 0.1±0.1, respectively; n = 18) and the patching group (1.3±0.4 and 0.4±0.2, respectively; n = 19) compared with the control group (2.5±0.6 and 0.9±0.4, respectively; n = 19). After controlling for age, gender, number of prior injections, and physician administering the injection, patients in the nepafenac group reported significantly lower pain scores than those in the control group at 6 hours (1.3±0.6 less; P = 0.047) and 24 hours (0.7±0.3 less; P = 0.047). Although the patching group reported lower pain scores than the control group, this was not statistically significant (6 hours, P = 0.24; 24 hours, P = 0.29).
CONCLUSIONS


Nepafenac 0.3% was effective as a single drop in reducing pain at 6 and 24 hours after IVI compared with placebo. Limited patching was associated with lower pain scores than placebo, but the difference was not statistically significant. Additional studies are needed to determine the most effective method to maximize the patient's experience after an IVI without sacrificing outcomes.",2019,"Numeric Pain Rating Scale scores at 6 and 24 hours after IVI were lower in the nepafenac group (0.8±0.3 and 0.1±0.1, respectively; n = 18) and the patching group (1.3±0.4 and 0.4±0.2, respectively; n = 19) compared with the control group (2.5±0.6 and 0.9±0.4, respectively; n = 19).","['Fifty-six and 53 patients of the 60 patients enrolled completed the 6- and 24-hour follow-ups, respectively', 'Participants', 'Sixty patients receiving an IVI of', 'in 1 eye']","['bevacizumab, aflibercept, or triamcinolone acetonide', 'placebo', 'Topical Nepafenac 0.3% or Pressure Patching', 'Placebo', 'nepafenac 0.3%, a pressure patch for 2 hours, or a single drop of preservative-free artificial tears (control group', 'intravitreal injection (IVI', 'topical nepafenac 0.3% suspension and patching']","['pain', 'lower pain scores', 'Numeric Pain Rating Scale scores', 'Pain', 'Pain Control', 'Numeric Pain Rating Scale', 'Pain scores', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}]",60.0,0.227601,"Numeric Pain Rating Scale scores at 6 and 24 hours after IVI were lower in the nepafenac group (0.8±0.3 and 0.1±0.1, respectively; n = 18) and the patching group (1.3±0.4 and 0.4±0.2, respectively; n = 19) compared with the control group (2.5±0.6 and 0.9±0.4, respectively; n = 19).","[{'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Kaplan', 'Affiliation': 'Retina Service, Department of Ophthalmology, New York Eye & Ear Infirmary of Mount Sinai, New York, New York.'}, {'ForeName': 'Owen J', 'Initials': 'OJ', 'LastName': 'Drinkwater', 'Affiliation': 'Retina Service, Department of Ophthalmology, New York Eye & Ear Infirmary of Mount Sinai, New York, New York; Weill-Cornell Medical College, New York, New York.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Lee', 'Affiliation': 'Retina Service, Department of Ophthalmology, New York Eye & Ear Infirmary of Mount Sinai, New York, New York.'}, {'ForeName': 'Ross B', 'Initials': 'RB', 'LastName': 'Chod', 'Affiliation': 'Retina Service, Department of Ophthalmology, New York Eye & Ear Infirmary of Mount Sinai, New York, New York.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Barash', 'Affiliation': 'Retina Service, Department of Ophthalmology, New York Eye & Ear Infirmary of Mount Sinai, New York, New York.'}, {'ForeName': 'Jerome V', 'Initials': 'JV', 'LastName': 'Giovinazzo', 'Affiliation': 'Retina Service, Department of Ophthalmology, New York Eye & Ear Infirmary of Mount Sinai, New York, New York.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gologorsky', 'Affiliation': 'Retina Service, Department of Ophthalmology, New York Eye & Ear Infirmary of Mount Sinai, New York, New York.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Jansen', 'Affiliation': 'Retina Service, Department of Ophthalmology, New York Eye & Ear Infirmary of Mount Sinai, New York, New York.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Rosen', 'Affiliation': 'Retina Service, Department of Ophthalmology, New York Eye & Ear Infirmary of Mount Sinai, New York, New York.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Gentile', 'Affiliation': 'Retina Service, Department of Ophthalmology, New York Eye & Ear Infirmary of Mount Sinai, New York, New York; Department of Ophthalmology, NYU Winthrop Hospital, Mineola, New York. Electronic address: rgentilenyee@gmail.com.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.04.022']
621,31212058,Role of human prefrontal cortex in the modulation of conditioned eyeblink responses.,"Classical conditioning of the eyeblink reflex (EBC) is a simple form of associative motor learning. EBC is heavily dependent on cerebellar function, but experimental studies also suggest that the prefrontal cortex (PFC) orchestrates a neuronal network which interacts with the cerebellum to mediate the conditioned eyeblink responses (CR). To further investigate the role of PFC for EBC in humans, we aimed in this study at assessing whether acquisition of CR can be modulated by focal repetitive transcranial magnetic stimulation (rTMS) given as theta burst stimulation (TBS) over the dorsolateral PFC (DLPFC). A standard delay conditioning paradigm with a 540 ms tone as conditioned stimulus (CS) coterminating with a 100 ms air puff as unconditioned stimulus (US) was used in a total of 60 healthy subjects (35 female, 25 male, mean age 28.4 ± 2.4 years). One hundred paired CS-US trials and 30 extinction CS alone trials were given. TBS was applied over the DLPFC ipsilaterally to the US during the acquisition phase. Subjects were randomly assigned to three groups (n = 20) using excitatory intermittent TBS (iTBS), inhibitory continuous TBS (cTBS) or sham stimulation. CR acquisition was significantly enhanced by iTBS (mean total CR incidence 63.1 ± 6.5%) and significantly reduced by cTBS (13 ± 2%) compared to sham stimulation (25.1 ± 6.7%). We provide thus physiological evidence that the acquisition of this type of associative learning is critically modulated by PFC activity in humans.",2019,CR acquisition was significantly enhanced by iTBS (mean total CR incidence 63.1 ± 6.5%) and significantly reduced by cTBS (13 ± 2%) compared to sham stimulation (25.1 ± 6.7%).,"['60 healthy subjects (35 female, 25 male, mean age 28.4\u2009±\u20092.4 years']","['TBS', '540\u2009ms tone as conditioned stimulus (CS) coterminating with a 100\u2009ms air puff as unconditioned stimulus (US', 'Classical conditioning of the eyeblink reflex (EBC', 'excitatory intermittent TBS (iTBS), inhibitory continuous TBS (cTBS) or sham stimulation']",['CR acquisition'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C0234403', 'cui_str': 'Unconditioned stimulus, function (observable entity)'}, {'cui': 'C0009649', 'cui_str': 'Conditioning, Classical'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",[],60.0,0.0280106,CR acquisition was significantly enhanced by iTBS (mean total CR incidence 63.1 ± 6.5%) and significantly reduced by cTBS (13 ± 2%) compared to sham stimulation (25.1 ± 6.7%).,"[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Nardone', 'Affiliation': 'Department of Neurology, Franz Tappeiner Hospital, Merano, Italy; Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria; Karl Landsteiner Institut für Neurorehabilitation und Raumfahrtneurologie, Salzburg, Austria. Electronic address: raffaele.nardone@asbmeran-o.it.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Langthaler', 'Affiliation': 'Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria; Department of Mathematics, Paris Lodron University of Salzburg, Austria.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Höller', 'Affiliation': 'Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Golaszewski', 'Affiliation': 'Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria; Karl Landsteiner Institut für Neurorehabilitation und Raumfahrtneurologie, Salzburg, Austria.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Versace', 'Affiliation': 'Department of Neurorehabilitation, Hospital of Vipiteno, Vipiteno, Italy; Research Unit for Neurorehabilitation South Tyrol, Bolzano, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Sebastianelli', 'Affiliation': 'Department of Neurorehabilitation, Hospital of Vipiteno, Vipiteno, Italy; Research Unit for Neurorehabilitation South Tyrol, Bolzano, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Brigo', 'Affiliation': 'Department of Neurology, Franz Tappeiner Hospital, Merano, Italy; Department of Neuroscience, Biomedicine and Movement Science, University of Verona, Italy.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Saltuari', 'Affiliation': 'Department of Neurorehabilitation, Hospital of Vipiteno, Vipiteno, Italy; Research Unit for Neurorehabilitation South Tyrol, Bolzano, Italy; Department of Neurology, Hochzirl Hospital, Zirl, Austria.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Trinka', 'Affiliation': 'Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University, Salzburg, Austria; Centre for Cognitive Neurosciences Salzburg, Salzburg, Austria; University for Medical Informatics and Health Technology, UMIT, Hall in Tirol, Austria.'}]",Behavioural brain research,['10.1016/j.bbr.2019.112027']
622,31481504,A Phase I Study of the Combination of Rituximab and Ipilimumab in Patients with Relapsed/Refractory B-Cell Lymphoma.,"PURPOSE


Based on the potential for ipilimumab (I) to augment T-cell activation, we hypothesize that ipilimumab would augment the efficacy of rituximab (R) in patients with relapsed/refractory (R/R) CD20 + non-Hodgkin's lymphoma (NHL). This phase I study aimed to identify a recommended phase 2 dose, document toxicities, and preliminarily assess efficacy and potential predictive biomarkers.
PATIENTS AND METHODS


Thirty-three patients with R/R CD20 + B-cell lymphoma received R at 375 mg/m 2 weekly for 4 weeks and I at 3 mg/kg on day 1 and every 3 weeks for four doses. Responding patients went on to maintenance with each agent given every 12 weeks. To facilitate correlative analysis, the expansion phase randomized patients to simultaneous R+I versus R with I delayed 2 weeks.
RESULTS


Toxicity was manageable; no dose-limiting toxicity was observed at the doses studied. When considering the entire cohort, efficacy was modest, with an objective response rate (ORR) of 24% and median progression-free survival (PFS) of 2.6 months. However, in follicular lymphoma patients, the ORR was 58% with a median PFS of 5.6 months. The randomized comparison of R with R+I demonstrated that R+I resulted in more effective B-cell depletion (BCD). Both B-cell depletion and the ratio of CD45RA - regulatory T cell (Treg) to Treg were associated with response at all time points.
CONCLUSIONS


The combination of R+I has manageable toxicity and encouraging efficacy in R/R follicular lymphoma. The ratio of CD45RA - Tregs to total Tregs, and peripheral BCD should be studied further as potential predictors of response.",2019,"Both B cell depletion and the ratio of CD45RA- Treg to Treg were associated with response at all time points.
","['Thirty-three patients with R/R CD20+ B-cell lymphoma received R at 375mg/m 2  weekly for 4 weeks and', 'patients with relapsed/refractory (R/R) CD20+ NHL', 'Patients with Relapsed/Refractory B-Cell Lymphoma']",['Rituximab and Ipilimumab'],"['median progression-free survival (PFS', 'objective response rate (ORR', 'ORR', 'effective B cell depletion (BCD', 'limiting toxicity']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079731', 'cui_str': 'B-Cell Lymphomas'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0333668', 'cui_str': 'Depletion (morphologic abnormality)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",33.0,0.0214727,"Both B cell depletion and the ratio of CD45RA- Treg to Treg were associated with response at all time points.
","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Tuscano', 'Affiliation': 'UC Davis Comprehensive Cancer Center, Sacramento, California. jtuscano@ucdavis.edu.'}, {'ForeName': 'Emanual', 'Initials': 'E', 'LastName': 'Maverakis', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Groshen', 'Affiliation': 'Biostatistics Core, University of Southern California/Norris Cancer Center, Los Angeles, California.'}, {'ForeName': 'Denice', 'Initials': 'D', 'LastName': 'Tsao-Wei', 'Affiliation': 'Biostatistics Core, University of Southern California/Norris Cancer Center, Los Angeles, California.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Luxardi', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Merleev', 'Affiliation': 'Department of Dermatology, UC Davis, Sacramento, California.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Beaven', 'Affiliation': 'University of North Carolina Comprehensive Cancer Center, Chapel Hill, North Carolina.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'DiPersio', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Popplewell', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, Duarte, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kirschbaum', 'Affiliation': 'Taiho Oncology, Princeton, New Jersey.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Schroeder', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Newman', 'Affiliation': 'Division of Molecular Pharmacology, Department of Medical Oncology, City of Hope, Duarte, California, USA.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0438']
623,31622732,A Randomized-Controlled Phase 2 Study of the MET Antibody Emibetuzumab in Combination with Erlotinib as First-Line Treatment for EGFR Mutation-Positive NSCLC Patients.,"INTRODUCTION


The hepatocyte growth factor receptor mesenchymal-epithelial transition (MET) is reported to be a negative prognostic marker in EGFR-mutant NSCLC and involved in resistance to EGFR inhibitors. Emibetuzumab, a humanized immunoglobulin G4 monoclonal bivalent MET antibody, blocks ligand-dependent and ligand-independent hepatocyte growth factor/MET signaling. This phase 2 study compared erlotinib with and without emibetuzumab in first-line treatment of EGFR-mutant metastatic NSCLC.
METHODS


Patients with stage IV EGFR-mutant NSCLC and disease control after an 8-week lead-in with erlotinib (150 mg daily) were randomized to continue taking erlotinib with or without emibetuzumab (750 mg every 2 weeks). The primary end point was progression-free survival (PFS). Additional end points included overall survival, overall response rate, safety, pharmacokinetics, and exploratory analysis of MET expression.
RESULTS


No significant difference in median PFS was observed in the intent-to-treat population (9.3 months with emibetuzumab + erlotinib versus 9.5 months with erlotinib monotherapy [hazard ratio (HR) = 0.89, 90% confidence interval (CI): 0.64-1.23]). The median overall survival was 34.3 months with emibetuzumab plus erlotinib versus 25.4 months with erlotinib (HR = 0.74, 90% CI: 0.49-1.11). Emibetuzumab plus erlotinib was well tolerated, with peripheral edema and mucositis as the only adverse events occurring 10% or more frequently relative to erlotinib. Exploratory post hoc analysis showed an improvement of 15.3 months in median PFS for the 24 patients with the highest MET expression (MET expression level of 3+ in ≥90% of tumor cells) (20.7 with emibetuzumab + erlotinib versus 5.4 months with erlotinib [HR = 0.39, 90% CI: 0.17-0.91]).
CONCLUSIONS


No statistically significant difference in PFS was noted in the intent-to-treat population. Exploratory analysis confirmed that high MET expression is a negative prognostic marker for patients treated with erlotinib, indicating that emibetuzumab plus erlotinib may provide clinically meaningful benefit.",2020,Median OS was 34.3 months for emibetuzumab+erlotinib and 25.4 months for erlotinib (HR = 0.74; 90% CI: 0.49-1.11).,"['EGFR-mutation Positive NSCLC Patients', 'Patients with Stage IV EGFR-mutant NSCLC and disease control following an 8-week lead-in with', '24 patients with highest MET expression (MET 3+ in ≥90% of tumor cells']","['erlotinib (150 mg QD', 'erlotinib±emibetuzumab', 'continue erlotinib with or without emibetuzumab', 'Emibetuzumab', 'Emibetuzumab+erlotinib']","['tolerated with peripheral edema and mucositis', 'overall survival (OS), overall response rate, safety, pharmacokinetics, and exploratory analysis of MET expression', 'median PFS', 'progression-free survival (PFS', 'PFS', 'Median OS']","[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}]","[{'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0298044,Median OS was 34.3 months for emibetuzumab+erlotinib and 25.4 months for erlotinib (HR = 0.74; 90% CI: 0.49-1.11).,"[{'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Scagliotti', 'Affiliation': 'Department of Oncology, Università degli Studi di Torino, Orbassano, Italy. Electronic address: giorgio.scagliotti@unito.it.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'CHU Grenoble-Alpes, Oncologie Thoracique, Grenoble, France.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kollmeier', 'Affiliation': 'Lungenklinik Heckeshorn, Helios Klinikum Emil von Behring, Berlin, Germany.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Favaretto', 'Affiliation': 'Medical Oncology, Azienda ULSS 2 Marca Trevigiana, Treviso, Italy.'}, {'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Cho', 'Affiliation': 'Gachon University Gil Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Grosch', 'Affiliation': 'Thoraxklinik Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kimmich', 'Affiliation': 'Klinik Schillerhöhe, Gerlingen, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girard', 'Affiliation': 'Institute of Thorax Curie Montsouris, Curie Institute, Paris, France.'}, {'ForeName': 'Chun-Ming', 'Initials': 'CM', 'LastName': 'Tsai', 'Affiliation': 'Taipei Veterans General Hospital, Taipei, Republic of China.'}, {'ForeName': 'Te-Chun', 'Initials': 'TC', 'LastName': 'Hsia', 'Affiliation': 'China Medical University, Taichung, Republic of China.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Brighenti', 'Affiliation': 'Oncology Department, Cremona Hospital Institutes, Cremona, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schumann', 'Affiliation': 'Hospital association Kempten-Oberallgäu, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Xuejing Aimee', 'Initials': 'XA', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Sameera R', 'Initials': 'SR', 'LastName': 'Wijayawardana', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Gruver', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Wallin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Mansouri', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Wacheck', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Gee-Chen', 'Initials': 'GC', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Republic of School of Medicine, National Yang-Ming University, Taipei, Republic of China.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.10.003']
624,31629805,Treatment of atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream.,"BACKGROUND


Atopic dermatitis (AD) is a highly pruritic chronic inflammatory skin disorder. Ruxolitinib, a selective inhibitor of Janus kinase 1 and Janus kinase 2, potently suppresses cytokine signaling involved in AD pathogenesis.
OBJECTIVE


We sought to evaluate the efficacy and safety of ruxolitinib (RUX) cream in adults with AD.
METHODS


In this phase 2 study (NCT03011892), 307 adult patients with AD, an Investigator's Global Assessment score of 2 or 3 (mild or moderate), and 3% to 20% affected body surface area were equally randomized for 8 weeks of double-blind treatment to RUX (1.5% twice daily [BID], 1.5% once daily [QD], 0.5% QD, 0.15% QD), vehicle, or triamcinolone cream (0.1% BID for 4 weeks, then vehicle for 4 weeks). Subsequently, patients could apply 1.5% RUX BID for 4 additional weeks of open-label treatment. The primary end point was the comparison between 1.5% RUX cream BID and vehicle in mean percentage change from baseline in Eczema Area and Severity Index at week 4.
RESULTS


All RUX regimens demonstrated therapeutic benefit at week 4; 1.5% BID provided the greatest improvement in Eczema Area and Severity Index (71.6% vs 15.5%; P < .0001) and Investigator's Global Assessment responses (38.0% vs 7.7%; P < .001) versus vehicle. Rapid reductions in the itch numerical rating scale score occurred within 36 hours (1.5% BID vs vehicle, ‒1.8 vs ‒0.2; P < .0001) and were sustained through 12 weeks. Patients who transitioned to 1.5% RUX BID improved in all measures. RUX was not associated with clinically significant application-site reactions.
CONCLUSIONS


RUX cream provided rapid and sustained improvements in AD symptoms and was well tolerated.",2020,"Ruxolitinib, a selective inhibitor of Janus kinase (JAK)-1 and JAK2, potently suppresses cytokine signaling involved in AD pathogenesis.
","['adults with AD', ""307 adult patients with AD, an Investigator's Global Assessment (IGA) score of 2 or 3 (mild or moderate), and 3%‒20% affected body surface area""]","['RUX', 'triamcinolone cream', 'RUX cream', 'ruxolitinib cream', 'Ruxolitinib Cream (JAK1/JAK2 Inhibitor', 'ruxolitinib (RUX) cream', 'Triamcinolone Cream']","['IGA responses', 'tolerated', 'Eczema Area and Severity Index (EASI', 'efficacy and safety', 'therapeutic benefit', 'itch numerical rating scale score', 'AD symptoms', 'EASI', 'atopic dermatitis (AD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]",307.0,0.118593,"Ruxolitinib, a selective inhibitor of Janus kinase (JAK)-1 and JAK2, potently suppresses cytokine signaling involved in AD pathogenesis.
","[{'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Washington University School of Medicine, St Louis, Mo. Electronic address: briankim@wustl.edu.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Howell', 'Affiliation': 'Incyte Corporation, Wilmington, Del.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Incyte Corporation, Wilmington, Del.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Nasir', 'Affiliation': 'Wake Research Associates LLC, Raleigh, NC.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kuligowski', 'Affiliation': 'Incyte Corporation, Wilmington, Del.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.08.042']
625,31768618,"The Effects of Different Exercise Trainings on Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit in Healthy Subjects.","Suprahyoid muscle activation and tongue pressure force play a critical role for swallowing function. In addition, dysphagia limit is one of most important factors indicating swallowing efficiency. The purpose of this study was to compare the effects of 8-week training sessions of three different exercises including chin tuck against resistance (CTAR), Shaker exercises and chin tuck exercise with theraband on suprahyoid muscle activity, anterior tongue pressure and dysphagia limit in healthy subjects. Thirty-six healthy volunteers aged between 18 and 40 years who scored below 3 points from Turkish version of Eating Assessment Tool (T-EAT-10) were included in the study, and all participants were divided into three groups randomly. Maximal suprahyoid muscle activations and dysphagia limit of participants were assessed by superficial electromyography. CTAR and chin tuck exercise with theraband increased the maximum suprahyoid muscle activation (p 1  = 0.004, p 2  = 0.018), whereas Shaker exercise did not increase maximal suprahyoid muscle activation (p = 0.507) after exercise training. CTAR and chin tuck exercise with theraband increased tongue pressure (p 1  = 0.045, p 2  = 0.041), while Shaker exercise did not increase anterior tongue pressure (p = 0.248). There was no statistically significant difference in dysphagia limits in three groups between before and after exercise training (p > 0.05). As a result, although CTAR seems to be the most effective exercise in most parameters, chin tuck exercise with theraband can also be used as an alternative to CTAR to improve suprahyoid muscle activity and tongue pressure.",2020,"CTAR and chin tuck exercise with theraband increased tongue pressure (p 1  = 0.045, p 2  = 0.041), while Shaker exercise did not increase anterior tongue pressure (p = 0.248).","['Healthy Subjects', 'healthy subjects', 'Thirty-six healthy volunteers aged between 18 and 40\xa0years who scored below 3 points from Turkish version of Eating Assessment Tool (T-EAT-10']","['Different Exercise Trainings', 'exercises including chin tuck against resistance (CTAR), Shaker exercises and chin tuck exercise with theraband']","['Suprahyoid Muscle Activation, Tongue Pressure Force and Dysphagia Limit', 'maximal suprahyoid muscle activation', 'Maximal suprahyoid muscle activations and dysphagia limit', 'suprahyoid muscle activity, anterior tongue pressure and dysphagia limit', 'tongue pressure', 'anterior tongue pressure', 'dysphagia limits', 'maximum suprahyoid muscle activation', 'CTAR and chin tuck exercise']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}]","[{'cui': 'C1744679', 'cui_str': 'Structure of suprahyoid muscle'}, {'cui': 'C0040408', 'cui_str': 'Tongue'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0226945', 'cui_str': 'Structure of body of tongue'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",36.0,0.0123338,"CTAR and chin tuck exercise with theraband increased tongue pressure (p 1  = 0.045, p 2  = 0.041), while Shaker exercise did not increase anterior tongue pressure (p = 0.248).","[{'ForeName': 'Hasan Erkan', 'Initials': 'HE', 'LastName': 'Kılınç', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Lokman Hekim University, Sogutozu, Ankara, 06510, Turkey. erkankilinc86@hotmail.com.'}, {'ForeName': 'Selen Serel', 'Initials': 'SS', 'LastName': 'Arslan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Numan', 'Initials': 'N', 'LastName': 'Demir', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Karaduman', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey.'}]",Dysphagia,['10.1007/s00455-019-10079-w']
626,32410463,Empagliflozin in Heart Failure: Diuretic and Cardiorenal Effects.,"BACKGROUND


Sodium-glucose cotransporter-2 inhibitors improve heart failure-related outcomes. The mechanisms underlying these benefits are not well understood, but diuretic properties may contribute. Traditional diuretics such as furosemide induce substantial neurohormonal activation, contributing to the limited improvement in intravascular volume often seen with these agents. However, the proximal tubular site of action of the sodium-glucose cotransporter-2 inhibitors may help circumvent these limitations.
METHODS


Twenty patients with type 2 diabetes mellitus and chronic, stable heart failure completed a randomized, placebo-controlled crossover study of empagliflozin 10 mg daily versus placebo. Patients underwent an intensive 6-hour biospecimen collection and cardiorenal phenotyping at baseline and again after 14 days of study drug. After a 2-week washout, patients crossed over to the alternate therapy with the above protocol repeated.
RESULTS


Oral empagliflozin was rapidly absorbed as evidenced by a 27-fold increase in urinary glucose excretion by 3 hours ( P <0.0001). Fractional excretion of sodium increased significantly with empagliflozin monotherapy versus placebo (fractional excretion of sodium, 1.2±0.7% versus 0.7±0.4%;  P =0.001), and there was a synergistic effect in combination with bumetanide (fractional excretion of sodium, 5.8±2.5% versus 3.9±1.9%;  P =0.001). At 14 days, the natriuretic effect of empagliflozin persisted, resulting in a reduction in blood volume (-208 mL [interquartile range, -536 to 153 mL] versus -14 mL [interquartile range, -282 to 335 mL];  P =0.035) and plasma volume (-138 mL, interquartile range, -379 to 154±453 mL;  P =0.04). This natriuresis was not, however, associated with evidence of neurohormonal activation because the change in norepinephrine was superior ( P =0.02) and all other neurohormones were similar ( P <0.34) during the empagliflozin versus placebo period. Furthermore, there was no evidence of potassium wasting ( P =0.20) or renal dysfunction ( P >0.11 for all biomarkers), whereas both serum magnesium ( P <0.001) and uric acid levels ( P =0.008) improved.
CONCLUSIONS


Empagliflozin causes significant natriuresis, particularly when combined with loop diuretics, resulting in an improvement in blood volume. However, off-target electrolyte wasting, renal dysfunction, and neurohormonal activation were not observed. This favorable diuretic profile may offer significant advantage in the management of volume status in patients with heart failure and may represent a mechanism contributing to the superior long-term heart failure outcomes observed with these agents. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03027960.",2020,"Fractional excretion of sodium (FENa) increased significantly with empagliflozin monotherapy vs. placebo (FENa 1.2 ± 0.7% vs. 0.7 ± 0.4% p=0.001) and there was a synergistic effect in combination with bumetanide (FENa 5.8 ± 2.5% vs. 3.9 ± 1.9%, p=0.001).","['HF patients', '20 patients with type-2 diabetes and chronic, stable HF completed a randomized', 'Heart Failure']","['bumetanide', 'empagliflozin', 'empagliflozin monotherapy vs. placebo', ""Sodium-glucose cotransporter-2 inhibitors (SGLT-2i's"", 'intensive 6-hour biospecimen collection and cardio-renal phenotyping', 'Empagliflozin', 'Oral empagliflozin', 'empagliflozin vs. placebo', 'empagliflozin 10mg daily vs. placebo', 'placebo']","['plasma volume', 'urinary glucose excretion', 'serum magnesium (p<0.001) and uric acid levels', 'synergistic effect', 'Fractional excretion of sodium (FENa', 'blood volume', 'renal dysfunction', 'renal dysfunction, and neurohormonal activation', 'natriuretic effect', 'potassium wasting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0006376', 'cui_str': 'Bumetanide'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0428601', 'cui_str': 'Measurement of fractional excretion of sodium'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C3179308', 'cui_str': 'Natriuretic Effects'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]",20.0,0.14824,"Fractional excretion of sodium (FENa) increased significantly with empagliflozin monotherapy vs. placebo (FENa 1.2 ± 0.7% vs. 0.7 ± 0.4% p=0.001) and there was a synergistic effect in combination with bumetanide (FENa 5.8 ± 2.5% vs. 3.9 ± 1.9%, p=0.001).","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Veena S', 'Initials': 'VS', 'LastName': 'Rao', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ivey-Miranda', 'Affiliation': 'Hospital de Cardiologia, Instituto Mexicano del Seguro Social, Mexico City, Mexico (J.I.-M.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fleming', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mahoney', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Maulion', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Suda', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, New York (N.S.).'}, {'ForeName': 'Krishmita', 'Initials': 'K', 'LastName': 'Siwakoti', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolism, University of Alabama at Birmingham (K.S.).'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jacoby', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Riello', 'Affiliation': 'Division of Pharmacy (R.R.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Bellumkonda', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Cox', 'Affiliation': 'Department of Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville, TN (Z.C.).'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN (S.C.).'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Yale School of Nursing, West Haven, CT (S.J.).'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Turner', 'Affiliation': 'Department of Internal Medicine, Section of Cardiovascular Medicine (M.G., V.S.R., J.F., D.M., C.M., T.A., D.J., L.B., J.M.T.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'F Perry', 'Initials': 'FP', 'LastName': 'Wilson', 'Affiliation': 'Clinical and Translational Research Accelerator (F.P.W.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson (J.B.).'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology (S.E.I.), Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Testani', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.045691']
627,31179505,Impact of force magnitude on effectiveness in cervical headgear therapy: a cephalometric analysis.,"AIM


The main aim of this study was to study the impact of different force magnitudes on effectiveness in cervical headgear (CHG) therapy.
MATERIALS AND METHODS


Forty patients were treated with CHG with light (L; 300 g) or heavy (H; 500 g) force in this controlled clinical trial. Patients were asked to wear CHG for 10 hours/day for 10 months. The inner bow of the CHG was expanded (3-4 mm) and the long outer bow bent (10-20 degree) upward in relation to the inner bow. Adherence to instructions and force magnitude in CHG use was monitored by electronic module (Smartgear, Swissorthodontics, Switzerland). Lateral cephalograms were taken before (T1) and after (T2) the treatment and studied with modified Pancherz analysis using a Planmeca Romexis Ceph module (Planmeca, Finland).
RESULTS


In both groups, skeletal and dental effects were seen. The only statistically significant difference in cephalometric analysis was the inclination of upper incisors at T1 (P = 0.010) and at T2 (P = 0.011). In both groups, a reduction in Sella-Nasion- point A (SNA) angle was found: L group T1 82.7degree (SD ± 3.6degree), T2 82.0degree (SD ± 3.5 degree) and H group T1 82.6 degree (SD ± 4.7 degree), T2 81.5 degree (SD ± 4.5 degree), but no statistically significant difference between the groups. Children in the L group used CHG statistically significantly more than those in the H group (10.0 ± 1.5 hour, and 8.3 ± 2.1 hour, respectively, P = 0.002).
CONCLUSION


Children with lower force CHG seem to adhere better to instructions for CHG use. After 10 months of use, no statistically significant differences were found in dental or skeletal outcome. However, in the H group, the outcome was achieved with less daily hours of use.",2019,"Children in the L group used CHG statistically significantly more than those in the H group (10.0 ± 1.5 hour, and 8.3 ± 2.1 hour, respectively, P = 0.002).
","['Children with lower force', 'Forty patients were treated with']",['CHG with light (L; 300 g) or heavy'],"['Sella-Nasion- point A (SNA) angle', 'cephalometric analysis', 'dental or skeletal outcome', 'skeletal and dental effects', 'CHG']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1527601', 'cui_str': '(alphaMe)Chg'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}]","[{'cui': 'C0934420', 'cui_str': 'Nasion'}, {'cui': 'C2924612', 'cui_str': 'Cephalometric point A'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0407698', 'cui_str': 'Orthodontic cephalogram (procedure)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1527601', 'cui_str': '(alphaMe)Chg'}]",40.0,0.0479585,"Children in the L group used CHG statistically significantly more than those in the H group (10.0 ± 1.5 hour, and 8.3 ± 2.1 hour, respectively, P = 0.002).
","[{'ForeName': 'Tuula H', 'Initials': 'TH', 'LastName': 'Talvitie', 'Affiliation': 'Oral and Maxillofacial Unit, Tampere University Hospital, Turku, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Helminen', 'Affiliation': 'Research, Development and Innovation Centre, Tampere University Hospital, Turku, Finland.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Karsila', 'Affiliation': 'Turku Municipal Health Care Services, Dental Teaching Unit, Turku, Finland.'}, {'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Varho', 'Affiliation': 'Turku Municipal Health Care Services, Dental Teaching Unit, Turku, Finland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Signorelli', 'Affiliation': 'Clinic for Orthodontics and Pediatric Dentistry, Center for Dental Medicine, University of Zurich, Switzerland.'}, {'ForeName': 'Pertti', 'Initials': 'P', 'LastName': 'Pirttiniemi', 'Affiliation': 'Department of Oral Development and Orthodontics, Research Unit of Oral Health Sciences.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Peltomäki', 'Affiliation': 'Oral and Maxillofacial Unit, Tampere University Hospital, Turku, Finland.'}]",European journal of orthodontics,['10.1093/ejo/cjz022']
628,31575021,Baseline Serum Vitamin A and D Levels Determine Benefit of Oral Vitamin A&D Supplements to Humoral Immune Responses Following Pediatric Influenza Vaccination.,"Maximizing vaccine efficacy is critical, but previous research has failed to provide a one-size-fits-all solution. Although vitamin A and vitamin D supplementation studies have been designed to improve vaccine efficacy, experimental results have been inconclusive. Information is urgently needed to explain study discrepancies and to provide guidance for the future use of vitamin supplements at the time of vaccination. We conducted a randomized, blinded, placebo-controlled study of influenza virus vaccination and vitamin supplementation among 2 to 8 (inclusive) year old children over three seasons, including 2015-2016 ( n  = 9), 2016-2017 ( n  = 44), and 2017-2018 ( n  = 26). Baseline measurements of vitamins A and D were obtained from all participants. Measurements were of serum retinol, retinol-binding protein (RBP, a surrogate for retinol), and 25-hydroxyvitamin D (25(OH)D). Participants were stratified into two groups based on high and low incoming levels of RBP. Children received two doses of the seasonal influenza virus vaccine on days 0 and 28, either with an oral vitamin supplement (termed A&D; 20,000 IU retinyl palmitate and 2000 IU cholecalciferol) or a matched placebo. Hemagglutination inhibition (HAI) antibody responses were evaluated toward all four components of the influenza virus vaccines on days 0, 28, and 56. Our primary data were from season 2016-2017, as enrollment was highest in this season and all children exhibited homogeneous and negative HAI responses toward the Phuket vaccine at study entry. Responses among children who entered the study with insufficient or deficient levels of RBP and 25(OH)D benefited from the A&D supplement ( p  < 0.001 for the day 28 Phuket response), whereas responses among children with replete levels of RBP and 25(OH)D at baseline were unaffected or weakened ( p  = 0.02 for the day 28 Phuket response). High baseline RBP levels associated with high HAI titers, particularly for children in the placebo group (baseline RBP correlated positively with Phuket HAI titers on day 28,  r  = 0.6,  p  = 0.003). In contrast, high baseline 25(OH)D levels associated with weak HAI titers, particularly for children in the A&D group (baseline 25(OH)D correlated negatively with Phuket HAI titers on day 28,  r  = -0.5,  p  = 0.02). Overall, our study demonstrates that vitamin A&D supplementation can improve immune responses to vaccines when children are vitamin A and D-insufficient at baseline. Results provide guidance for the appropriate use of vitamins A and D in future clinical vaccine studies.",2019,"High baseline RBP levels associated with high HAI titers, particularly for children in the placebo group (baseline RBP correlated positively with Phuket HAI titers on day 28,  r  = 0.6,  p  = 0.003).","['2 to 8 (inclusive) year old children over three seasons, including 2015-2016 ( n  = 9), 2016-2017 ( n  = 44), and 2017-2018 ( n  = 26', 'Pediatric Influenza Vaccination']","['Oral Vitamin A&D Supplements', 'vitamin A and vitamin D supplementation', 'oral vitamin supplement (termed A&D; 20,000 IU retinyl palmitate and 2000 IU cholecalciferol', 'seasonal influenza virus vaccine', 'placebo', 'influenza virus vaccination and vitamin supplementation', 'vitamin A&D supplementation']","['vaccine efficacy', 'serum retinol, retinol-binding protein (RBP, a surrogate for retinol), and 25-hydroxyvitamin D (25(OH)D', 'High baseline RBP levels', 'Hemagglutination inhibition (HAI) antibody responses', 'HAI titers', 'Phuket HAI titers', 'negative HAI responses']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0681579', 'cui_str': 'Vitamin supplement'}, {'cui': 'C0073115', 'cui_str': 'retinyl palmitate'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4316910', 'cui_str': 'Influenzavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1533658', 'cui_str': 'Vitamin supplement therapy'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C1446172', 'cui_str': 'Retinol binding protein measurement (procedure)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",,0.313418,"High baseline RBP levels associated with high HAI titers, particularly for children in the placebo group (baseline RBP correlated positively with Phuket HAI titers on day 28,  r  = 0.6,  p  = 0.003).","[{'ForeName': 'Nehali', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. nehali.patel@stjude.org.""}, {'ForeName': 'Rhiannon R', 'Initials': 'RR', 'LastName': 'Penkert', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. rhiannon.penkert@stjude.org.""}, {'ForeName': 'Bart G', 'Initials': 'BG', 'LastName': 'Jones', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. bart.jones@stjude.org.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Sealy', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. bob.sealy@stjude.org.""}, {'ForeName': 'Sherri L', 'Initials': 'SL', 'LastName': 'Surman', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. sherri.surman@stjude.org.""}, {'ForeName': 'Yilun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. yilun.sun@stjude.org.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. li.tang@stjude.org.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'DeBeauchamp', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. jennifer.deBeauchamp@stjude.org.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. ashley.webb@stjude.org.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Richardson', 'Affiliation': ""Department of Pharmaceuticals, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. julie.richardson@stjude.org.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Heine', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. ryan.heine@stjude.org.""}, {'ForeName': 'Ronald H', 'Initials': 'RH', 'LastName': 'Dallas', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. ronald.dallas@stjude.org.""}, {'ForeName': 'A Catharine', 'Initials': 'AC', 'LastName': 'Ross', 'Affiliation': 'Department of Nutritional Sciences, Pennsylvania State University, University Park, PA 16802, USA. acr6@psu.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Webby', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. richard.webby@stjude.org.""}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Hurwitz', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. julia.hurwitz@stjude.org.""}]",Viruses,['10.3390/v11100907']
629,31180299,Conversion From Cyclosporine to Once-Daily Tacrolimus on 50:1 mg Basis: A Short-Term Pilot Study.,"OBJECTIVES


In addition to graft dysfunction, renal transplant recipients on cyclosporine may be switched to tacrolimus to reduce its drug-related secondary clinical effects and undesirable cosmetic side effects. However, the dose level of once-daily tacrolimus for these patients has yet to be established. The objective of this prospective study was to confirm the safety of converting stable renal transplant recipients on cyclosporine to once-daily tacrolimus at a 50:1 mg ratio.
MATERIALS AND METHODS


Our study enrolled 17 patients receiving cyclosporine who were observed for 3 months. Graft biopsies did not reveal any acute rejection, and the conversion ratio to once-daily tacrolimus was 50:1 mg. Dose adjustments were made to achieve a target tacrolimus trough concentration of 3 to 5 ng/mL at 2 weeks, and graft biopsies were taken after the 3-month observation period.
RESULTS


Dose adjustment was required in 7 recipients (41.2%) within 3 months of conversion. None of the recipients had acute cellular rejection or C4d deposition, and the mean estimated glomerular filtration rate of 38.7 ± 11.0 mL/min/1.73 m2 at baseline was significantly improved to 42.0 ± 10.0 mL/min/1.73 m2 at month 3.
CONCLUSIONS


Although recipients of renal transplant can be forced to discontinue cyclosporine administration due to undesirable adverse effects, our study showed that a once-daily dose of tacrolimus may be safe when administered at a conversion ratio of 50:1.",2020,"Graft biopsies did not reveal any acute rejection, and the conversion ratio to once-daily tacrolimus was 50:1 mg.",['17 patients receiving'],"['cyclosporine', 'Tacrolimus', 'tacrolimus', 'cyclosporine to once-daily tacrolimus', 'Cyclosporine']","['acute cellular rejection or C4d deposition', 'glomerular filtration rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0877453', 'cui_str': 'Acute cellular rejection'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",17.0,0.135204,"Graft biopsies did not reveal any acute rejection, and the conversion ratio to once-daily tacrolimus was 50:1 mg.","[{'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'From the Department of Urology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Uchida', 'Affiliation': ''}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Kosoku', 'Affiliation': ''}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Iwai', 'Affiliation': ''}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Kabei', 'Affiliation': ''}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Nishide', 'Affiliation': ''}, {'ForeName': 'Toshihide', 'Initials': 'T', 'LastName': 'Naganuma', 'Affiliation': ''}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Kumada', 'Affiliation': ''}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Takemoto', 'Affiliation': ''}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Nakatani', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2018.0337']
630,31180763,Long-term functional outcomes after cardiac rehabilitation in older patients. Data from the Cardiac Rehabilitation in Advanced aGE: EXercise TRaining and Active follow-up (CR-AGE EXTRA) randomised study.,"AIM


Cardiac rehabilitation promotes functional recovery after cardiac events. Our study aimed at evaluating whether, compared to usual care, a home-based exercise programme with monthly reinforcement sessions adds long-term functional benefits to those obtained with cardiac rehabilitation in the elderly.
METHODS


After a 4-week outpatient cardiac rehabilitation, 160 of 197 patients aged 75 years and older screened for eligibility with different indications for cardiac rehabilitation, were randomly assigned to a control (C) or an active treatment (T) group. During a 12-month follow-up, C patients received usual care, while T patients were prescribed a standardised set of home-based exercises with centre-based monthly reinforcements for the first 6 months. The main (peak oxygen consumption) and three secondary outcome measures (distance walked in 6 minutes, inferior limbs peak 90° Torque strength, health-related quality of life) were assessed at baseline, at random assignment and at 6 and 12-month follow-ups with the cardiopulmonary exercise test, 6-minute walking test, isokinetic dynamometer and the Short Form-36 questionnaire, respectively.
RESULTS


Both C and T groups obtained a significant and similar improvement from baseline to the end of the 4-week cardiac rehabilitation programme in the three functional outcome measures. However, at univariable and age and gender-adjusted analysis of variance for repeated measures, changes from random assignment to 6 or 12-month follow-up in any outcome measure were similar in the C and T groups.
CONCLUSION


Results from this randomised study suggest that a home-based exercise programme with monthly reinforcements does not add any long-term functional benefit beyond those offered by a conventional, 4-week outpatient cardiac rehabilitation programme.
TRIAL REGISTRATION


ClinicalTrial.gov Identifier: NCT00641134.",2019,Both C and T groups obtained a significant and similar improvement from baseline to the end of the 4-week cardiac rehabilitation programme in the three functional outcome measures.,"['Advanced aGE', '197 patients aged 75 years and older screened for eligibility with different indications for cardiac rehabilitation', 'older patients']","['Cardiac rehabilitation', 'EXercise TRaining and Active follow-up', 'usual care, while T patients were prescribed a standardised set of home-based exercises with centre-based monthly reinforcements for the first 6 months', 'control (C) or an active treatment (T) group']","['cardiopulmonary exercise test, 6-minute walking test, isokinetic dynamometer and the Short Form-36 questionnaire, respectively', 'main (peak oxygen consumption) and three secondary outcome measures (distance walked in 6 minutes, inferior limbs peak 90° Torque strength, health-related quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",197.0,0.0662752,Both C and T groups obtained a significant and similar improvement from baseline to the end of the 4-week cardiac rehabilitation programme in the three functional outcome measures.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Pratesi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Baldasseroni', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Costanza', 'Initials': 'C', 'LastName': 'Burgisser', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Orso', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Barucci', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Maria Vittoria', 'Initials': 'MV', 'LastName': 'Silverii', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Venturini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ungar', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Marchionni', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fattirolli', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Italy.'}]",European journal of preventive cardiology,['10.1177/2047487319854141']
631,25570401,User-driven control increases cortical activity during treadmill walking: an EEG study.,"Treadmills provide a safe and efficient method for gait rehabilitation but treadmill based training paradigms have not been shown to create superior results when compared with traditional physical therapy methods such as overground training. One explanation for this may be that walking at a constant, fixed speed requires little mental engagement from the user, which has been postulated as a key factor in the success of motor learning. To increase mental engagement, we developed a user-driven treadmill control scheme. In this paper we use electroencephalography (EEG) to compare cortical activity during user-driven (active) walking with activity on a normal (passive) treadmill in nine healthy subjects. We used independent component analysis (ICA) to isolate brain activity from artifactual components. We fit equivalent dipole sources to each brain component and clustered these across subjects. Our analysis revealed that relative to the passive treadmill, active walking resulted in statistically significant decreases in spectral power, i.e. desynchronization, in the anterior cingulate, sensorimotor cortices, and posterior parietal lobe of the cortex. These results indicate that user-driven treadmills more fully engage the motor cortex and therefore could facilitate better training outcomes than a traditional treadmill.",2014,"Our analysis revealed that relative to the passive treadmill, active walking resulted in statistically significant decreases in spectral power, i.e. desynchronization, in the anterior cingulate, sensorimotor cortices, and posterior parietal lobe of the cortex.",['nine healthy subjects'],"['electroencephalography (EEG', 'cortical activity during user-driven (active) walking with activity on a normal (passive) treadmill']","['cortical activity', 'spectral power, i.e. desynchronization, in the anterior cingulate, sensorimotor cortices, and posterior parietal lobe of the cortex']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0030560', 'cui_str': 'Parietal Cortex'}]",9.0,0.0264216,"Our analysis revealed that relative to the passive treadmill, active walking resulted in statistically significant decreases in spectral power, i.e. desynchronization, in the anterior cingulate, sensorimotor cortices, and posterior parietal lobe of the cortex.","[{'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Bulea', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Jonghyun Kim', 'Affiliation': ''}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Damiano', 'Affiliation': ''}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Stanley', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Hyung-Soon Park', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2014.6944033']
632,31156083,Sixteen-week versus standard eight-week prednisolone therapy for childhood nephrotic syndrome: the PREDNOS RCT.,"BACKGROUND


The optimal corticosteroid regimen for treating the presenting episode of steroid-sensitive nephrotic syndrome (SSNS) remains uncertain. Most UK centres use an 8-week regimen, despite previous systematic reviews indicating that longer regimens reduce the risk of relapse and frequently relapsing nephrotic syndrome (FRNS).
OBJECTIVES


The primary objective was to determine whether or not an extended 16-week course of prednisolone increases the time to first relapse. The secondary objectives were to compare the relapse rate, FRNS and steroid-dependent nephrotic syndrome (SDNS) rates, requirement for alternative immunosuppressive agents and corticosteroid-related adverse events (AEs), including adverse behaviour and costs.
DESIGN


Randomised double-blind parallel-group placebo-controlled trial, including a cost-effectiveness analysis.
SETTING


One hundred and twenty-five UK paediatric departments.
PARTICIPANTS


Two hundred and thirty-seven children presenting with a first episode of SSNS. Participants aged between 1 and 15 years were randomised (1 : 1) according to a minimisation algorithm to ensure balance of ethnicity (South Asian, white or other) and age (≤ 5 or ≥ 6 years).
INTERVENTIONS


The control group ( n  = 118) received standard course (SC) prednisolone therapy: 60 mg/m 2 /day of prednisolone in weeks 1-4, 40 mg/m 2  of prednisolone on alternate days in weeks 5-8 and matching placebo on alternate days in weeks 9-18 (total 2240 mg/m 2 ). The intervention group ( n  = 119) received extended course (EC) prednisolone therapy: 60 mg/m 2 /day of prednisolone in weeks 1-4; started at 60 mg/m 2  of prednisolone on alternate days in weeks 5-16, tapering by 10 mg/m 2  every 2 weeks (total 3150 mg/m 2 ).
MAIN OUTCOME MEASURES


The primary outcome measure was time to first relapse [Albustix ®  (Siemens Healthcare Limited, Frimley, UK)-positive proteinuria +++ or greater for 3 consecutive days or the presence of generalised oedema plus +++ proteinuria]. The secondary outcome measures were relapse rate, incidence of FRNS and SDNS, other immunosuppressive therapy use, rates of serious adverse events (SAEs) and AEs and the incidence of behavioural change [using Achenbach Child Behaviour Checklist (ACBC)]. A comprehensive cost-effectiveness analysis was performed. The analysis was by intention to treat. Participants were followed for a minimum of 24 months.
RESULTS


There was no significant difference in time to first relapse between the SC and EC groups (hazard ratio 0.87, 95% confidence interval 0.65 to 1.17; log-rank  p  = 0.3). There were also no differences in the incidence of FRNS (SC 50% vs. EC 53%;  p  = 0.7), SDNS (44% vs. 42%;  p  = 0.8) or requirement for other immunosuppressive therapy (56% vs. 54%;  p  = 0.8). The total prednisolone dose received following completion of study medication was 5475 mg vs. 6674 mg ( p  = 0.07). SAE rates were not significantly different (25% vs. 17%;  p  = 0.1) and neither were AEs, except poor behaviour (yes/no), which was less frequent with EC treatment. There were no differences in ACBC scores. EC therapy was associated with a mean increase in generic health benefit [0.0162 additional quality-adjusted life-years (QALYs)] and cost savings (£4369 vs. £2696).
LIMITATIONS


Study drug formulation may have prevented some younger children who were unable to swallow whole or crushed tablets from participating.
CONCLUSIONS


This trial has not shown any clinical benefit for EC prednisolone therapy in UK children. The cost-effectiveness analysis suggested that EC therapy may be cheaper, with the possibility of a small QALY benefit.
FUTURE WORK


Studies investigating EC versus SC therapy in younger children and further cost-effectiveness analyses are warranted.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN16645249 and EudraCT 2010-022489-29.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 26. See the NIHR Journals Library website for further project information.",2019,"SAE rates were not significantly different (25% vs. 17%;  p  = 0.1) and neither were AEs, except poor behaviour (yes/no), which was less frequent with EC treatment.","['Participants aged between 1 and 15 years', 'younger children', 'mg vs. 6674', 'UK children', 'childhood nephrotic syndrome', 'Two hundred and thirty-seven children presenting with a first episode of SSNS', 'One hundred and twenty-five UK paediatric departments', 'younger children who were unable to swallow whole or crushed tablets from participating']","['placebo', 'EC therapy', 'standard course (SC) prednisolone therapy: 60\u2009mg/m 2 /day of prednisolone', 'extended course (EC) prednisolone therapy: 60\u2009mg/m 2 /day of prednisolone', 'minimisation algorithm to ensure balance of ethnicity (South Asian, white or other) and age (≤\u20095 or ≥\u20096 years', 'prednisolone therapy', 'prednisolone', 'EC prednisolone therapy']","['relapse rate, incidence of FRNS and SDNS, other immunosuppressive therapy use, rates of serious adverse events (SAEs) and AEs and the incidence of behavioural change [using Achenbach Child Behaviour Checklist (ACBC', 'ACBC scores', 'SDNS', 'incidence of FRNS', 'generic health benefit', 'time to first relapse', 'SAE rates', 'cost savings', 'time to first relapse [Albustix ®  (Siemens Healthcare Limited, Frimley, UK)-positive proteinuria +++ or greater for 3 consecutive days or the presence of generalised oedema plus +++ proteinuria', 'relapse rate, FRNS and steroid-dependent nephrotic syndrome (SDNS) rates, requirement for alternative immunosuppressive agents and corticosteroid-related adverse events (AEs), including adverse behaviour and costs']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3874381', 'cui_str': 'Childhood nephrotic syndrome (disorder)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department (environment)'}, {'cui': 'C4048182', 'cui_str': 'Unable to swallow (finding)'}, {'cui': 'C0185060', 'cui_str': 'Crushing - action (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0002045'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021079', 'cui_str': 'Antirejection Therapy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C2724205', 'cui_str': '+++'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0151603', 'cui_str': 'Anasarca'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome (disorder)'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressants'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",237.0,0.513398,"SAE rates were not significantly different (25% vs. 17%;  p  = 0.1) and neither were AEs, except poor behaviour (yes/no), which was less frequent with EC treatment.","[{'ForeName': 'Nicholas Ja', 'Initials': 'NJ', 'LastName': 'Webb', 'Affiliation': ""Department of Paediatric Nephrology, University of Manchester, Manchester Academic Health Science Centre, Royal Manchester Children's Hospital, Manchester, UK.""}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Woolley', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tosin', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Brettell', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Emma N', 'Initials': 'EN', 'LastName': 'Barsoum', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Trompeter', 'Affiliation': 'Centre for Nephrology, University College London, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Cummins', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Ives', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23260']
633,32410200,Effect of Photobiomodulation on Ecchymosis after Rhinoplasty: A Randomized Single-Blind Controlled Trial.,"BACKGROUND


This study was conducted to compare the effect of photobiomodulation therapy (low-level laser therapy) on ecchymosis after rhinoplasty.
SUBJECTS AND METHODS


Sixty rhinoplasty candidates were randomly divided into two groups. Photobiomodulation, including red light (660 nm), infrared light (840 nm), and infrared laser, was used in the first group on the first postoperative day, and its effect on periorbital ecchymosis was evaluated.
RESULTS


The findings showed that low-power laser reduced ecchymosis significantly (p = 0.005 * ).
CONCLUSION


Photobiomodulation may be effectively used for reducing ecchymosis after rhinoplasty.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . RCT registration number is IRCT20080820001056N3.",2020,"The findings showed that low-power laser reduced ecchymosis significantly (p = 0.005 * ).
",['Sixty rhinoplasty candidates'],"['Photobiomodulation, including red light (660\xa0nm), infrared light (840\xa0nm), and infrared laser', 'photobiomodulation therapy (low-level laser therapy', 'Photobiomodulation']","['Ecchymosis', 'periorbital ecchymosis', 'ecchymosis']","[{'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C2053461', 'cui_str': 'Periorbital ecchymosis'}]",,0.0712924,"The findings showed that low-power laser reduced ecchymosis significantly (p = 0.005 * ).
","[{'ForeName': 'Somaye', 'Initials': 'S', 'LastName': 'Karimi', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sadeghi', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Amali', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Saedi', 'Affiliation': 'Otolaryngology Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Bagherkhan Street, Chamran Highway, Tehran, 141973141, Iran. saedi@tums.ac.ir.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01760-9']
634,31512330,Creatine supplementation improves performance above critical power but does not influence the magnitude of neuromuscular fatigue at task failure.,"NEW FINDINGS


What is the central question of this study? Does the magnitude of neuromuscular fatigue depend on the amount of work done (W') at task failure when cycling above critical power (CP)? What is the main finding and its importance? Creatine supplementation increases W' and enhances supra-CP performance, but induces similar magnitudes of neuromuscular fatigue at task failure compared to placebo. Increased W' does not lead to higher levels of neuromuscular fatigue. This supports the notion of a critical level of neuromuscular fatigue at task failure and challenges a direct causative link between W' depletion and neuromuscular fatigue.
ABSTRACT


The present study examined the effect of creatine supplementation on neuromuscular fatigue and exercise tolerance when cycling above critical power (CP). Eleven males performed an incremental cycling test with four to five constant-load trials to task failure (TTF) to obtain asymptote (CP) and curvature constant (W') of the power-duration relationship, followed by three constant-load supra-CP trials: (1) one TTF following placebo supplementation (PLA); (2) one TTF following creatine supplementation (CRE); and (3) one trial of equal duration to PLA following creatine supplementation (ISO). Neuromuscular assessment of the right knee extensors was performed pre- and post-exercise to measure maximal voluntary contraction (MVC), twitch forces evoked by single (Q pot  ) and paired high- (PS100) and low- (PS10) frequency stimulations and voluntary activation. Creatine supplementation increased TTF in CRE vs. PLA by ∼11% (P = 0.017) and work done above CP by ∼10% (P = 0.015), with no difference (P > 0.05) in reductions in MVC (-24 ± 8% vs. -20 ± 9%), Q pot  (-39 ± 13% vs. -32 ± 14%), PS10 (-42 ± 14% vs. -36 ± 13%), PS100 (-25 ± 10% vs. -18 ± 12%) and voluntary activation (-7 ± 8% vs. -5 ± 7%). No significant difference was found between ISO and either PLA or CRE (P > 0.05). These findings suggest similar levels of neuromuscular fatigue can be found following supra-CP cycling despite increases in performance time and amount of work done above CP, supporting the notion of a critical level of neuromuscular fatigue and challenging a direct causative link between W' depletion and neuromuscular fatigue.",2019,"Creatine supplementation increases W' and enhances supra-CP performance, but induces similar magnitudes of neuromuscular fatigue at task failure compared to placebo.",['Eleven males'],"['PLA following creatine supplementation (ISO', 'creatine supplementation', 'PS100', ""incremental cycling test with four to five constant-load trials to task failure (TTF) to obtain asymptote (CP) and curvature constant (W') of the power-duration relationship, followed by three constant-load supra-CP trials: (1) one TTF following placebo supplementation (PLA); (2) one TTF following creatine supplementation (CRE"", 'placebo', 'Creatine supplementation']","['TTF', ""W' and enhances supra-CP performance"", 'maximal voluntary contraction (MVC), twitch forces evoked by single (Q pot  ) and paired high- (PS100) and low- (PS10) frequency stimulations and voluntary activation', 'neuromuscular fatigue', 'ISO and either PLA or CRE', 'voluntary activation', 'neuromuscular fatigue and exercise tolerance']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch (finding)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue, function (observable entity)'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}]",,0.0659042,"Creatine supplementation increases W' and enhances supra-CP performance, but induces similar magnitudes of neuromuscular fatigue at task failure compared to placebo.","[{'ForeName': 'Lisa U', 'Initials': 'LU', 'LastName': 'Schäfer', 'Affiliation': 'Fatigue and Exercise Laboratory, School of Sport and Service Management, University of Brighton, Eastbourne, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hayes', 'Affiliation': 'Fatigue and Exercise Laboratory, School of Sport and Service Management, University of Brighton, Eastbourne, UK.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Dekerle', 'Affiliation': 'Fatigue and Exercise Laboratory, School of Sport and Service Management, University of Brighton, Eastbourne, UK.'}]",Experimental physiology,['10.1113/EP087886']
635,31150780,Instrumental Control Enhances Placebo Analgesia.,"Placebo analgesia is a robust phenomenon readily observed in both experimental and clinical settings. While researchers have begun to unpack its psychobiological mechanisms, important questions remain regarding how we can capitalize on the placebo effect to improve clinical pain outcomes. The current study tested whether providing individuals with instrumental control-that is, control over if and when they administer a treatment-is capable of enhancing placebo analgesia. Using an established electrocutaneous pain design, 87 healthy volunteers either received placebo conditioning with instrumental control over treatment administration, standard passive placebo conditioning without any control over treatment administration, or were allocated to natural history control group with no conditioning and were later tested at equivalent shock intensity with and without placebo applied. Both placebo groups demonstrated initial placebo analgesia. Importantly, however, those provided with instrumental control demonstrated significantly larger and longer lasting placebo analgesia as well as reduced anticipatory autonomic arousal than those receiving standard passive placebo conditioning. This suggests that providing instrumental control over treatment administration can facilitate placebo analgesia by enhancing its magnitude and durability. As such, providing instrumental control over treatment administration may be a cheap and ethical method of using the placebo effect to improve clinical pain outcomes. PERSPECTIVE: Placebo research typically involves passive designs where individuals have no control over treatment administration. We present novel data demonstrating that providing control over treatment administration substantially enhances both the magnitude and duration of placebo analgesia. As such, where possible, providing control may improve clinical pain outcomes via the placebo effect.",2019,"Importantly, however, those provided with instrumental control demonstrated significantly larger and longer lasting placebo analgesia as well as reduced anticipatory autonomic arousal than those receiving standard passive placebo conditioning.",['87 healthy volunteers either received'],"['Placebo', 'Placebo analgesia', 'placebo', 'placebo conditioning with instrumental control over treatment administration, standard passive placebo conditioning without any control over treatment administration, or were allocated to natural history control group with no conditioning and were later tested at equivalent shock intensity with and without placebo']","['anticipatory autonomic arousal', 'clinical pain outcomes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",87.0,0.271806,"Importantly, however, those provided with instrumental control demonstrated significantly larger and longer lasting placebo analgesia as well as reduced anticipatory autonomic arousal than those receiving standard passive placebo conditioning.","[{'ForeName': 'Biya', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Geers', 'Affiliation': 'School of Psychology, University of Toledo, Toledo, Ohio.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Barnes', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Colagiuri', 'Affiliation': 'School of Psychology, University of Sydney, Sydney, Australia. Electronic address: ben.colagiuri@sydney.edu.au.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.05.013']
636,31130005,A Pilot Study of a Sleep Intervention Delivered through Group Prenatal Care to Overweight and Obese Women.,"OBJECTIVES


We sought to investigate the feasibility of a behavioral sleep intervention for insomnia, delivered through group prenatal care and the relationship of this intervention to improvements in insomnia symptoms and sleep quality.
PARTICIPANTS


Women receiving prenatal care and reporting a pre-pregnancy BMI of ≥25 kg/m 2  and sleep duration of <6.5 h per night.
METHODS


Participants were randomized to group prenatal care or group prenatal care with a behavioral sleep intervention, adapted from cognitive behavioral therapy for insomnia (CBT-I) online program Go! to Sleep®. In the second trimester (T1), late third trimester (T2) and 6-8 weeks postpartum (T3) study assessments were completed including the  Insomnia Severity Index, Pittsburgh Sleep Quality Index , fasting glucose and insulin and weight and height. Data were analyzed using independent samples t-tests, chi-square tests, correlations, and two-way repeated measures ANOVA where appropriate. P < .05 was set as the level of significance.
RESULTS


From May 2014 to April 2015, 311 women were evaluated for inclusion and 53 women were randomized to participate (27 intervention; 26 control), 15% were lost to follow up. The intervention group had lower third trimester and postpartum levels of moderate to severe insomnia (T2 50.0% vs 85.0% (p = .018) and T3 13.6% vs 52.4% (p-.008)) and mean insomnia severity scores (T2 (14.7 (±6.6) vs 19.3 (± 6.0) p = .02) and T3 (9.7 (±5.4) vs 15.1(±7.2) p = .01)) when compared to the control group.
CONCLUSION


A randomized controlled trial of a behavioral sleep intervention for insomnia delivered through group prenatal care led to improvements in insomnia symptoms.",2020,The intervention group had lower third trimester and postpartum levels of moderate to severe insomnia (T2 50.0% vs 85.0% (p = .018) and T3 13.6% vs 52.4% (p-.008)) and mean insomnia severity scores (T2 (14.7 (±6.6) vs 19.3 (± 6.0) p = .02) and T3 (9.7 (±5.4) vs 15.1(±7.2),"['Women receiving prenatal care and reporting a pre-pregnancy BMI of ≥25 kg/m 2  and sleep duration of <6.5 h per night', 'Participants ', 'to Overweight and Obese Women', 'From May 2014 to April 2015, 311 women were evaluated for inclusion and 53 women']","['prenatal care or group prenatal care with a behavioral sleep intervention, adapted from cognitive behavioral therapy for insomnia (CBT-I) online program Go! to Sleep®', 'behavioral sleep intervention', 'Sleep Intervention Delivered through Group Prenatal Care']","['lower third trimester and postpartum levels of moderate to severe insomnia', 'mean insomnia severity scores', 'Insomnia Severity Index, Pittsburgh Sleep Quality Index , fasting glucose and insulin and weight and height', 'insomnia symptoms and sleep quality', 'insomnia symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0032982', 'cui_str': 'Pregnancy Trimesters'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",311.0,0.0605809,The intervention group had lower third trimester and postpartum levels of moderate to severe insomnia (T2 50.0% vs 85.0% (p = .018) and T3 13.6% vs 52.4% (p-.008)) and mean insomnia severity scores (T2 (14.7 (±6.6) vs 19.3 (± 6.0) p = .02) and T3 (9.7 (±5.4) vs 15.1(±7.2),"[{'ForeName': 'Mary Ashley', 'Initials': 'MA', 'LastName': 'Cain', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Brumley', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of midwifery, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}, {'ForeName': 'Adetola', 'Initials': 'A', 'LastName': 'Louis-Jacques', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Drerup', 'Affiliation': 'Department of sleep disorders, Cleveland Clinic Sleep Disorders Center , Cleveland, OH.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Stern', 'Affiliation': 'Department of Child and Family Studies, University of South Florida , Tampa.'}, {'ForeName': 'Judette M', 'Initials': 'JM', 'LastName': 'Louis', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of South Florida Morsani College of Medicine , Tampa, Florida, USA.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1613995']
637,31145885,"Timing of postpartum etonogestrel-releasing implant insertion and bleeding patterns, weight change, 12-month continuation and satisfaction rates: a randomized controlled trial.","OBJECTIVES


To evaluate whether timing of etonogestrel (ENG) implant insertion during the postpartum period affects maternal bleeding patterns, body mass index (BMI) and 12-month satisfaction and continuation rates.
STUDY DESIGN


This is a secondary analysis of an open, randomized, controlled trial. Postpartum women were block-randomized to early (up to 48 h postpartum) or delayed (6 weeks postpartum) insertion of an ENG implant. Bleeding patterns and BMI were evaluated every 90 days for 12 months. At 12 months, we measured implant continuation rates and used Likert and face scales to measure users' satisfaction. The level of significance was 0.4% (adjusted by Bonferroni test for multiplicity).
RESULTS


We enrolled 100 postpartum women; we randomized 50 to early and 50 to delayed postpartum ENG implant insertion. Bleeding patterns were similar between groups. Amenorrhea rates were high in both groups during the follow-up (52%-56% and 46%-62% in the early and delayed insertion group, respectively). Prolonged bleeding episodes were unusual in both groups during the follow-up (0-2%). Maternal BMI was similar between groups and decreased over time. Twelve-month continuation rates were similar between groups (early insertion: 98% vs. delayed insertion: 100%, p=.99). Most participants were either very satisfied or satisfied with the ENG implant in both groups (p=.9).
CONCLUSION


Women who underwent immediate postpartum insertion of the ENG implant have similar bleeding patterns, BMI changes, and 12-month satisfaction and continuation rates compared to those who underwent delayed insertion.
IMPLICATIONS


Our results from a secondary analysis of a clinical trial support that satisfaction, continuation and bleeding patterns do not differ when women received contraceptive implants immediately postpartum or at 6 weeks. However, the emphasis on infant growth in the trial and easy access to delayed placement may have influenced results.",2019,"Twelve-month continuation rates were similar between groups (early insertion: 98% vs. delayed insertion: 100%, p=.99).",['We enrolled 100 postpartum women'],"['delayed postpartum ENG implant insertion', 'postpartum etonogestrel-releasing implant insertion', 'etonogestrel (ENG) implant insertion']","[""implant continuation rates and used Likert and face scales to measure users' satisfaction"", 'bleeding patterns, weight change, 12-month continuation and satisfaction rates', 'Amenorrhea rates', 'Maternal BMI', 'satisfaction, continuation and bleeding patterns', 'bleeding patterns, BMI changes, and 12-month satisfaction and continuation rates', 'Prolonged bleeding episodes', 'maternal bleeding patterns, body mass index (BMI) and 12-month satisfaction and continuation rates', 'Bleeding patterns and BMI', 'Bleeding patterns']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0047683', 'cui_str': 'Etonogestrel'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0222045'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",100.0,0.239124,"Twelve-month continuation rates were similar between groups (early insertion: 98% vs. delayed insertion: 100%, p=.99).","[{'ForeName': 'Carolina Sales', 'Initials': 'CS', 'LastName': 'Vieira', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil. Electronic address: carol.sales@uol.com.br.'}, {'ForeName': 'Mariane Nunes', 'Initials': 'MN', 'LastName': 'de Nadai', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Lilian Sheila', 'Initials': 'LS', 'LastName': 'de Melo Pereira do Carmo', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Giordana Campos', 'Initials': 'GC', 'LastName': 'Braga', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Bruna Fregonesi', 'Initials': 'BF', 'LastName': 'Infante', 'Affiliation': ""Women' s Health Reference Center of Ribeirão Preto. Avenida Wanderley Taffo, 330 Quintino Facci II, CEP: 14070-000, Ribeirão Preto, SP, Brazil.""}, {'ForeName': 'Bianca M', 'Initials': 'BM', 'LastName': 'Stifani', 'Affiliation': ""Department of Obstetrics, Gynecology and Women's Health of Albert Einstein College of Medicine / Montefiore Medical Center, 1300 Morris Park Avenue, Bronx, NY, 10461, USA.""}, {'ForeName': 'Rui Alberto', 'Initials': 'RA', 'LastName': 'Ferriani', 'Affiliation': 'Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Silvana Maria', 'Initials': 'SM', 'LastName': 'Quintana', 'Affiliation': ""Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil. Avenida Bandeirantes, 3900 Campus Universitário Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil; Women' s Health Reference Center of Ribeirão Preto. Avenida Wanderley Taffo, 330 Quintino Facci II, CEP: 14070-000, Ribeirão Preto, SP, Brazil.""}]",Contraception,['10.1016/j.contraception.2019.05.007']
638,32410198,The Role of Skin Thickness in the Choice of a Rhinoplasty Technique for Thin-Skinned Patients: Analysis of Long-Term Results and Patient Satisfaction.,"INTRODUCTION


This randomized controlled study aimed to analyse the long-term results of thin-skinned patients who underwent rhinoplasty.
MATERIALS AND METHODS


All the included study patients had the following characteristics: underwent primary rhinoplasty for functional and/or cosmetic problems, were thin-skinned, had been followed for almost 2 years, underwent both standard pre- and post-operative photography, had a good understanding of the Italian language, and had signed a consent form for inclusion in the study. The patients were randomly divided into 4 groups as follows: group 1, camouflage of the dorsum by diced cartilage; group 2, camouflage of the dorsum with lipofilling; group 3, camouflage of the dorsum by a temporal fascia graft; and group 4 (control group), without camouflage of the dorsum. Patients answered the Italian version of the FACE-Q rhinoplasty module. The Obagi skin pinch test was used to measure nasal skin thickness. We compared pre- and post-operative patient satisfaction with the appearance of their nose between the 4 patient groups by the Chi-squared test for unpaired data. Two plastic surgeons reviewed all the post-operative photographs of the study patients and rated the photographs on a scale of 1 to 5.
RESULTS


A total of 101 patients who underwent primary rhinoplasty between January 2016 and March 2018 in our department of plastic surgery and satisfied the inclusion criteria were enrolled in this study. The mean patient age was 38.5 years. The mean follow-up time was 2.5 years. The differences between the preoperative and post-operative FACE-Q values for group 1 were significant (P < 0.01), whereas the differences between the preoperative and post-operative FACE-Q values for the other groups were not significant. The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01). Groups 2 and 4 underwent more secondary procedures than groups 1 and 3 (P < 0.01). The 2 reviewers determined that patient groups 1 and 3 obtained more satisfactory outcomes than groups 1 and 4 (P < 0.01).
CONCLUSIONS


This was the first randomized study to demonstrate that diced cartilage grafts used for thin-skinned patients was the best approach for obtaining a satisfactory long-term outcome and durable natural appearance.
LEVEL OF EVIDENCE I


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01).,"['All the included study patients had the following characteristics: underwent primary rhinoplasty for functional and/or cosmetic problems, were thin-skinned, had been followed for almost 2\xa0years, underwent both standard pre- and post-operative photography, had a good understanding of the Italian language, and had signed a consent form for inclusion in the study', '101 patients who underwent primary rhinoplasty between January 2016 and March 2018 in our department of plastic surgery and satisfied the inclusion criteria were enrolled in this study', 'thin-skinned patients who underwent rhinoplasty', 'mean patient age was 38.5\xa0years']","['diced cartilage grafts', 'camouflage of the dorsum by diced cartilage; group 2, camouflage of the dorsum with lipofilling; group 3, camouflage of the dorsum by a temporal fascia graft; and group 4 (control group), without camouflage of the dorsum']","['preoperative and post-operative FACE-Q values', 'satisfactory outcomes', 'Skin Thickness', 'nasal skin thickness']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0038911', 'cui_str': 'Plastic surgery - specialty'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1271247', 'cui_str': 'Grafting of cartilage'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0225213', 'cui_str': 'Temporal fascia structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]",101.0,0.030166,The results for group 1 patients remained stable over the long-term follow-up compared with the results for other groups (P < 0.01).,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Barone', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy. maurosabbarone@gmail.com.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Cogliandro', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Salzillo', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ciarrocchi', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Panasiti', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Coppola', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Russo', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Tenna', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Persichetti', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01763-6']
639,31165191,Continued Beneficial Effects of Burosumab in Adults with X-Linked Hypophosphatemia: Results from a 24-Week Treatment Continuation Period After a 24-Week Double-Blind Placebo-Controlled Period.,"Burosumab, a fully human monoclonal antibody to FGF23, is the only approved treatment for X-linked hypophosphatemia (XLH), a rare genetic disorder characterized by renal phosphate wasting and substantial cumulative musculoskeletal morbidity. During an initial 24-week randomized, controlled trial, 134 adults with XLH received burosumab 1 mg/kg (n = 68) or placebo (n = 66) every 4 weeks. After 24 weeks, all subjects received open-label burosumab until week 48. This report describes the efficacy and safety of burosumab during the open-label treatment period. From weeks 24-48, serum phosphorus concentrations remained normal in 83.8% of participants who received burosumab throughout and were normalized in 89.4% who received burosumab after placebo. By week 48, 63.1% of baseline fractures/pseudofractures healed fully with burosumab, compared with 35.2% with burosumab after placebo. In both groups, burosumab was associated with clinically significant and sustained improvement from baseline to week 48 in scores for patient-reported outcomes of stiffness, pain, physical function, and total distance walked in 6 min. Rates of adverse events were similar for burosumab and placebo. There were no fatal adverse events or treatment-related serious adverse events. Nephrocalcinosis scores did not change from baseline by more than one grade at either week 24 or 48. These data demonstrate that in participants with XLH, continued treatment with burosumab is well tolerated and leads to sustained correction of serum phosphorus levels, continued healing of fractures and pseudofractures, and sustained improvement in key musculoskeletal impairments.",2019,"In both groups, burosumab was associated with clinically significant and sustained improvement from baseline to week 48 in scores for patient-reported outcomes of stiffness, pain, physical function, and total distance walked in 6 min.","['participants with XLH', 'Adults with X-Linked Hypophosphatemia', '134 adults with XLH received burosumab 1\xa0mg/kg (n\u2009=\u200968) or']","['Placebo', 'placebo']","['Rates of adverse events', 'stiffness, pain, physical function, and total distance walked in 6\xa0min', 'efficacy and safety', 'Nephrocalcinosis scores', 'serum phosphorus concentrations', 'fatal adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3540852', 'cui_str': 'Hypophosphatemia, X-Linked'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4301607', 'cui_str': 'burosumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027709', 'cui_str': 'Nephrocalcinosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",134.0,0.122848,"In both groups, burosumab was associated with clinically significant and sustained improvement from baseline to week 48 in scores for patient-reported outcomes of stiffness, pain, physical function, and total distance walked in 6 min.","[{'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Portale', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA. aportale@ucsf.edu.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Carpenter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Brandi', 'Affiliation': 'Azienda Ospedaliero Universitaria Careggi - CTO, Florence, Italy.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Briot', 'Affiliation': 'CHU Paris Centre, Paris, France.'}, {'ForeName': 'Hae Ii', 'Initials': 'HI', 'LastName': 'Cheong', 'Affiliation': ""Seoul National University Children's Hospital, Seoul, Korea.""}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Cohen-Solal', 'Affiliation': 'Hôpital Lariboisière, Paris, France.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Crowley', 'Affiliation': ""St Vincent's University Hospital Elm Park, Dublin, Ireland.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Jan De Beur', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Eastell', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Imanishi', 'Affiliation': 'Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Imel', 'Affiliation': 'Indiana University Department of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ing', 'Affiliation': 'The Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Ito', 'Affiliation': 'The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Javaid', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kamenicky', 'Affiliation': 'CHU de Bicêtre, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Keen', 'Affiliation': 'Royal National Orthopaedic Hospital, Stanmore, UK.'}, {'ForeName': 'Takuo', 'Initials': 'T', 'LastName': 'Kubota', 'Affiliation': 'Osaka University Hospital, Osaka, Japan.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Lachmann', 'Affiliation': 'University College of London Hospital, London, UK.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Perwad', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Pisit', 'Initials': 'P', 'LastName': 'Pitukcheewanont', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Ralston', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Takeuchi', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Okayama Saiseikai General Hospital, Okayama, Japan.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Weber', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Han-Wook', 'Initials': 'HW', 'LastName': 'Yoo', 'Affiliation': 'Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Theodore-Oklota', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Mealiffe', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'San Martin', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Insogna', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}]",Calcified tissue international,['10.1007/s00223-019-00568-3']
640,31747677,Adiponectin Gene Variant rs266729 Interacts with Different Macronutrient Distribution of Two Different Hypocaloric Diets.,"BACKGROUND


The role of ADIPOQ gene variants in weight loss after different dietary fat amounts remains unclear.
OBJECTIVE


Our aim was to analyze the effects of ADIPOQ gene polymorphism rs266729 on metabolic changes after two different amounts of dietary fat in two hypocaloric diets.
DESIGN


A population of 283 obese patients was recruited in a randomized clinical trial with two diets: Diet HF (high-fat diet: 38% carbohydrates, 24% proteins, and 38% fats) versus Diet LF (low-fat diet: 53% carbohydrates, 20% proteins, and 27% fats). Before and after 3 months, an anthropometric evaluation, an assessment of nutritional intake, and a biochemical analysis were carried out. The variant of the ADIPOQgene was assessed by real-time PCR.
RESULTS


Weight loss was similar with both diets in both genotypes (CC vs. CG+GG). After dietary intervention with Diet HF, only subjects with CC genotype showed a significant improvement in insulin levels (-3.3 ± 0.6 vs. -1.8 ± 0.9 mU/L; p = 0.03) and the homeostasis model assessment for insulin resistance (HOMA-IR) (-1.3 ± 0.1 vs. -0.8 ± 0.2 units; p = 0.02). After Diet LF, subjects with CC genotype showed a significant improvement in total cholesterol levels (CC vs. CG+GG) (-15.3 ± 1.4 vs. -6.4 ± 1.3 mg/dL; p = 0.01), LDL cholesterol (-14.6 ± 1.8 vs. -6.4 ± 1.3 mg/dL; p = 0.01), insulin levels (-4.6 ± 1.0 vs. -1.6 ± 0.5 mU/L; p = 0.01), and HOMA-IR (-1.6 ± 0.1 vs. -1.0 ± 0.2 units; p = 0.02). Only subjects with CC genotype showed a significant increase of adiponectin levels after both diets (CC vs. CG+GG): Diet HF (10.6 ± 2.0 vs. 1.8 ± 1.0 ng/dL; p = 0.01) and Diet LF (16.1 ± 2.8 vs. 1.3 ± 1.0 ng/dL: p = 0.03).
CONCLUSION


CC genotype of ADIPOQgene variantrs266729 was associated with a better metabolic response after both diets. Additionally, Diet LF produced a significant improvement in lipid profile in noncarriers of allele G.",2020,Only subjects with CC genotype showed a significant increase of adiponectin levels after both diets (CC vs. CG+GG): Diet HF (10.6 ± 2.0 vs. 1.8 ± 1.0 ng/dL; p = 0.01) and Diet LF (16.1 ± 2.8 vs. 1.3,['283 obese patients'],"['Diet LF', 'diets: Diet HF (high-fat diet: 38% carbohydrates, 24% proteins, and 38% fats) versus Diet LF']","['lipid profile', 'insulin levels', 'homeostasis model assessment for insulin resistance (HOMA-IR', 'metabolic response', 'total cholesterol levels', 'adiponectin levels', 'Weight loss', 'LDL cholesterol']","[{'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0521974', 'cui_str': 'Diet, High-Fat'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",283.0,0.0224633,Only subjects with CC genotype showed a significant increase of adiponectin levels after both diets (CC vs. CG+GG): Diet HF (10.6 ± 2.0 vs. 1.8 ± 1.0 ng/dL; p = 0.01) and Diet LF (16.1 ± 2.8 vs. 1.3,"[{'ForeName': 'Daniel Antonio', 'Initials': 'DA', 'LastName': 'de Luis', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain, dadluis@yahoo.es.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Aller', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Department of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}]",Lifestyle genomics,['10.1159/000503863']
641,31169661,"Correlates of Gut Function in Children Hospitalized for Severe Acute Malnutrition, a Cross-sectional Study in Uganda.","OBJECTIVE


Children with severe acute malnutrition (SAM) may have impaired intestinal function, which can result in malabsorption, diarrhoea, and poor growth. This study evaluated the gut function of children with SAM using fecal and blood biomarkers and assessed their correlates.
METHODS


A cross-sectional study, nested in a randomized trial (www.isrctn.com, ISRCTN 16454889), was conducted at Mulago hospital, Uganda among subgroups of 400 children with complicated SAM and 30 community controls. Gut function was evaluated by 5 biomarkers: plasma citrulline, fecal myeloperoxidase and fecal neopterin, bacterially derived 16S rRNA gene and internal transcribed Spacer region (ITS) specific for Candida spp. in blood.
RESULTS


Compared with controls, children with SAM had lower median plasma citrulline (5.14 vs 27.4 μmol/L, P < 0.001), higher median fecal myeloperoxidase (18083 vs 7482 ng/mL, P = 0.001), and fecal neopterin (541 vs 210 nmol/L, P < 0.001). A higher blood concentration of 16S rRNA gene copy numbers was observed among children with SAM (95 vs 28 copies/μl, P = 0.05), whereas there was no difference in the blood concentration of Candida-specific ITS fragment.Among those with SAM, plasma citrulline was lower in children with edema, diarrhoea, dermatosis, and plasma C-reactive protein (CRP) >10 mg/L. Fecal neopterin was positively correlated with symptoms of fever and cough whereas it was negatively correlated with mid-upper arm circumference (MUAC), weight-for-height z score (WHZ), edema, and dermatosis.
CONCLUSIONS


Children with complicated SAM seem to have impaired gut function characterized by reduced enterocyte mass, intestinal inflammation, and increased bacterial translocation.",2019,"Among those with SAM, plasma citrulline was lower in children with oedema, diarrhoea, dermatosis, and plasma C-reactive protein (CRP) >10 mg/l.","['A cross-sectional study, nested in a randomized trial (http://www.isrctn.com, ISRCTN 16454889), was conducted at Mulago hospital, Uganda among subgroups of 400 children with complicated SAM and 30 community controls', 'children with SAM using fecal and blood biomarkers and assessed their correlates', 'Children with severe acute malnutrition (SAM', 'children hospitalized for severe acute malnutrition, a cross-sectional study in Uganda']",[],"['plasma citrulline', 'fecal neopterin', 'higher median fecal myeloperoxidase', 'Gut function', 'blood concentration of Candida specific ITS fragment', 'blood concentration of 16S rRNA gene copy numbers', 'Fecal neopterin', 'five biomarkers: plasma citrulline, fecal myeloperoxidase and fecal neopterin, bacterially derived 16S rRNA gene and internal transcribed Spacer region (ITS) specific for Candida in blood', 'median plasma citrulline', 'symptoms of fever and cough']","[{'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}]",[],"[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0068527', 'cui_str': '2-Amino-6-(1,2,3-trihydroxypropyl)-4(3H)-pteridinone'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0006836', 'cui_str': 'Monilia'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0035899', 'cui_str': 'Ribosomal RNA Genes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0221874', 'cui_str': 'Spacer (physical object)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}]",400.0,0.0530718,"Among those with SAM, plasma citrulline was lower in children with oedema, diarrhoea, dermatosis, and plasma C-reactive protein (CRP) >10 mg/l.","[{'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Lanyero', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Benedikte', 'Initials': 'B', 'LastName': 'Grenov', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Nicolette N', 'Initials': 'NN', 'LastName': 'Barungi', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Hanifa', 'Initials': 'H', 'LastName': 'Namusoke', 'Affiliation': 'Mwanamugimu Nutrition Unit, Department of Paediatrics, Mulago National Referral Hospital, Kampala, Uganda.'}, {'ForeName': 'Kim F', 'Initials': 'KF', 'LastName': 'Michaelsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Ezekiel', 'Initials': 'E', 'LastName': 'Mupere', 'Affiliation': 'Department of Paediatrics and Child Health, Makerere University College of Health Sciences, P.O. Box 7072, Kampala, Uganda.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mølgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Department of Veterinary and Animal Science.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Frøkiær', 'Affiliation': 'Department of Veterinary and Animal Science.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wiese', 'Affiliation': 'Department of Food Science, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Musemma K', 'Initials': 'MK', 'LastName': 'Muhammed', 'Affiliation': 'Department of Food Science, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Pesu', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Nielsen', 'Affiliation': 'Department of Food Science, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Friis', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Maren Jh', 'Initials': 'MJ', 'LastName': 'Rytter', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Frederiksberg C, Denmark.'}, {'ForeName': 'Vibeke B', 'Initials': 'VB', 'LastName': 'Christensen', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen Ø, Denmark.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002381']
642,31029045,"Randomized study of the effects of cocoa-rich chocolate on the ventricle-arterial coupling and vascular function of young, healthy adults.","OBJECTIVES


The aim of this study was to evaluate and explore the benefits of long-term dark chocolate intake in young, healthy adults by measuring cardiovascular function.
METHODS


A randomized study was conducted with 30 healthy participants ages 18 to 27 y. Half of the participants ingested a 20-g dose of lower cocoa chocolate (LCC; ∼55%; 12.6 ± 1.4 mg equivalent of epicatechin/g) and the others ingested a daily dose of 20 g of higher cocoa chocolate (HCC; ∼90%; 18.2 ± 2.6 mg equivalent of epicatechin/g). A baseline evaluation was performed before the participants started ingesting the assigned chocolate for a 30-d period, after which a final evaluation was performed. Each evaluation included heart ultrasonography, carotid-femoral pulse wave velocity (PWV) and carotid pulse wave analysis, flow-mediated slowing (FMS), and an analysis of the ventricular-arterial coupling (VAC), which reflects the matching between the aorta and the left ventricle (ratio of arterial elastance to left ventricle elastance).
RESULTS


The baseline evaluation presented similar values within normal range in both groups. The positive vascular effects were overall more distinct in the group eating the HCC. No structural modifications on the heart were found after the intervention, notwithstanding cardiac function was improved on certain functional parameters in the HCC group only. A statistically significant improvement was depicted over the brachial and central systolic and pulse pressures in the HCC group, and a trend for improvement in the reflected waves component (Aix) and the FMS was also observed in the HCC, but not in the LCC group. VAC parameters were similar at baseline between groups, but showed a significant improvement in the HCC group after intervention, increasing from 0.674 to 0.719 (P = 0.004), so that the post-intervention VAC was significantly higher in the HCC group than in the LCC group (P < 0.05). In addition, significant variation was observed in both groups regarding arterial and left ventricle elastances, stroke work, and potential energy, with greater mean differences identified in the HCC group.
CONCLUSION


This study demonstrated that regular consumption of HCC has beneficial effects on the cardiovascular system in young, healthy adults, improving vascular function by reducing central brachial artery pressures and promoting vascular relaxation, and thus enhancing the matching of the arterial system with the left ventricle.",2019,"No structural modifications on the heart were found after the intervention, notwithstanding cardiac function was improved on certain functional parameters in the HCC group only.","['30 healthy participants ages 18 to 27 y. Half of the participants ingested a 20-g dose of lower cocoa chocolate (LCC; ∼55%; 12.6\xa0± 1.4 mg equivalent of epicatechin/g) and the others ingested a daily dose of 20 g of higher cocoa chocolate (HCC; ∼90%; 18.2\xa0± 2.6 mg equivalent of epicatechin/g', 'young, healthy adults', 'young, healthy adults by measuring cardiovascular function']","['LCC', 'HCC', 'long-term dark chocolate intake', 'cocoa-rich chocolate']","['VAC parameters', 'arterial and left ventricle elastances, stroke work, and potential energy', 'reflected waves component (Aix) and the FMS', 'heart ultrasonography, carotid-femoral pulse wave velocity (PWV) and carotid pulse wave analysis, flow-mediated slowing (FMS), and an analysis of the ventricular-arterial coupling (VAC', 'positive vascular effects', 'brachial and central systolic and pulse pressures', 'certain functional parameters']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C0008299', 'cui_str': 'Chocolate'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0014485', 'cui_str': '(2R,3R)-2-(3,4-Dihydroxyphenyl)-3,5,7-chromanetriol'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3853217', 'cui_str': 'Dark chocolate (substance)'}, {'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0008299', 'cui_str': 'Chocolate'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0018827', 'cui_str': 'Heart Ventricle'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1096529', 'cui_str': 'Carotid pulse'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",30.0,0.0502471,"No structural modifications on the heart were found after the intervention, notwithstanding cardiac function was improved on certain functional parameters in the HCC group only.","[{'ForeName': 'Telmo', 'Initials': 'T', 'LastName': 'Pereira', 'Affiliation': 'Polytechnic Institute of Coimbra, Coimbra Health School, LabinSaude, Portugal. Electronic address: telmo@estescoimbra.pt.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Bergqvist', 'Affiliation': 'University of Gothenburgh, Salgrenska Academy, Sweden.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Vieira', 'Affiliation': 'Polytechnic Institute of Coimbra, Coimbra Health School, LabinSaude, Portugal.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Grüner Sveälv', 'Affiliation': 'University of Gothenburgh, Salgrenska Academy, Sweden.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Castanheira', 'Affiliation': 'Polytechnic Institute of Coimbra, Coimbra Health School, LabinSaude, Portugal.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Conde', 'Affiliation': 'Polytechnic Institute of Coimbra, Coimbra Health School, LabinSaude, Portugal; University of Gothenburgh, Salgrenska Academy, Sweden.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.02.017']
643,30191395,A new checklist method enhances treatment compliance and response of behavioural therapy for primary monosymptomatic nocturnal enuresis: a prospective randomised controlled trial.,"PURPOSE


The aim of the study was to demonstrate the benefits of a newly-established written checklist of behavioural instructions for monosymptomatic nocturnal enuresis.
METHODS


From a total of 96 parents with children who complain of bedwetting three or more nights per week for at least 14 days, 79 were randomly divided into three groups. Group I (n = 27) were instructed to apply only behavioural therapy as a written guideline, Group II (n = 26) were instructed to apply behavioural therapy with a written checklist for parents to fully complete and Group III (n = 26) received desmopressin treatment plus verbal behavioural therapy. All participants were analysed in respect of compliance and the response rate to treatment over a time period of 8 weeks.
RESULTS


A total of 63 participants completed the study period. The participants in all three groups were similar in terms of the age of the child and the parents, number of siblings, and the educational and economic status of the parents (p > 0.05). High rates of treatment compliance were determined for the participants with the checklist compared to those with written guideline. No statistically significant difference was determined between Group II and III in respect of compliance rates (p = 0.12). The treatment response rates of the participants in Group I were significantly lower compared to those of Group II and III (p = 0.001) with no statistical difference determined between Groups II and III (p = 0.15).
CONCLUSION


The success rate of behavioural therapy for MNE can be increased with the newly-designed method of a written checklist form of behavioural instructions.",2019,No statistically significant difference was determined between Group II and III in respect of compliance rates (p = 0.12).,"['63 participants completed the study period', '96 parents with children who complain of bedwetting three or more nights per week for at least 14\xa0days, 79', 'primary monosymptomatic nocturnal enuresis', 'monosymptomatic nocturnal enuresis']","['instructed to apply only behavioural therapy as a written guideline, Group II (n\u2009=\u200926) were instructed to apply behavioural therapy with a written checklist for parents to fully complete and Group III', 'desmopressin treatment plus verbal behavioural therapy', 'behavioural therapy', 'newly-established written checklist of behavioural instructions']","['High rates of treatment compliance', 'compliance rates']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0270327', 'cui_str': 'Nighttime Urinary Incontinence'}]","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4319828', 'cui_str': 'Therapeutic Compliance'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",96.0,0.016859,No statistically significant difference was determined between Group II and III in respect of compliance rates (p = 0.12).,"[{'ForeName': 'Ahmet Metin', 'Initials': 'AM', 'LastName': 'Hascicek', 'Affiliation': 'Department of Urology, Medical Science University, Ankara Training and Research Hospital, 06340, Ankara, Turkey.'}, {'ForeName': 'Muhammet Fatih', 'Initials': 'MF', 'LastName': 'Kilinc', 'Affiliation': 'Department of Urology, Medical Science University, Ankara Training and Research Hospital, 06340, Ankara, Turkey. mdfatihkilinc@yahoo.com.'}, {'ForeName': 'Yildiray', 'Initials': 'Y', 'LastName': 'Yildiz', 'Affiliation': 'Department of Urology, Medical Science University, Ankara Training and Research Hospital, 06340, Ankara, Turkey.'}, {'ForeName': 'Cem Nedim', 'Initials': 'CN', 'LastName': 'Yuceturk', 'Affiliation': 'Department of Urology, Medical Science University, Ankara Training and Research Hospital, 06340, Ankara, Turkey.'}, {'ForeName': 'Omer Gokhan', 'Initials': 'OG', 'LastName': 'Doluoglu', 'Affiliation': 'Department of Urology, Medical Science University, Ankara Training and Research Hospital, 06340, Ankara, Turkey.'}]",World journal of urology,['10.1007/s00345-018-2478-1']
644,31124887,Dexamethasone Reduces Postoperative Nausea in Pediatric Upper Endoscopy With Deep Sedation: A Randomized Controlled Trial.,"OBJECTIVES


We aimed to evaluate the effect of a single dose of preoperative dexamethasone on postoperative nausea and vomiting (PONV), a frequent complication and a major cause of delayed recovery in pediatric upper gastrointestinal endoscopy (UGIE) under sedation.
METHODS


In this double-blind randomized controlled study, 98 children aged 2 to 14, with American Society of Anesthesiologists status I to II, and undergoing elective UGIE with deep sedation were included and randomly assigned to 2 groups. Preoperatively, after anesthesia induction with sodium thiopental and maintenance with sevoflurane, patients in the intervention (n = 49) and control (n = 49) groups, respectively received 0.1 mg/kg i.v. dexamethasone and 2 cm i.v. 0.9% saline. Postoperatively, PONV incidence was measured as the primary outcome.
RESULTS


PONV incidence was significantly less in dexamethasone group (8.2%) compared to the control group (26.5%) (difference = 18.3%, 95% confidence interval: 3.4%-33%, P = 0.016). For secondary outcomes, between-group differences were not statistically significant: incidence of bronchospasm or laryngospasm (both 4.1%, P = 1); emergence delirium assessed with Pediatric Anesthesia Emergence Delirium scale (5.9 ± 3.4 vs 5.7 ± 3.2, P = 0.751); Modified Aldrete score at 0 minutes (9.4 ± 0.8 vs 9.3 ± 0.9, P = 0.909) and at 5 minutes (9.5 ± 0.7 vs 9.4 ± 0.9, P = 0.527); and recovery time (21.1 ± 6.6 vs 23.4 ± 8.6 minutes, P = 0.130).
CONCLUSIONS


A single preoperative dose of i.v. dexamethasone reduces PONV in children undergoing elective UGIE with deep sedation, but has no significant effect on the patient recovery time or the incidence of postoperative bronchospasm or laryngospasm and emergence delirium.",2019,"dexamethasone reduces PONV in children undergoing elective UGIE with deep sedation, but has no significant effect on the patient recovery time or the incidence of postoperative bronchospasm or laryngospasm and emergence delirium.","['pediatric upper gastrointestinal endoscopy (UGIE) under sedation', 'children undergoing elective UGIE with deep sedation', 'Pediatric Upper Endoscopy with Deep Sedation', '98 children aged 2-14, with ASA status I-II, and undergoing elective UGIE with deep sedation']","['pre-operative dexamethasone', 'Dexamethasone', 'sodium thiopental and maintenance with sevoflurane', 'dexamethasone']","['bronchospasm or laryngospasm', 'Emergence delirium assessed with PAED scale', 'Postoperative Nausea', 'postoperative nausea and vomiting (PONV', 'PONV incidence', 'recovery time', 'Modified Aldrete score']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0222045'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3164884', 'cui_str': 'Modified Aldrete score (assessment scale)'}]",98.0,0.649725,"dexamethasone reduces PONV in children undergoing elective UGIE with deep sedation, but has no significant effect on the patient recovery time or the incidence of postoperative bronchospasm or laryngospasm and emergence delirium.","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Moheimani', 'Affiliation': ""Students' Scientific Research Center, School of Medicine.""}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002398']
645,31488353,1-Year Outcomes of Delayed Versus Immediate Intervention in Patients With Transient ST-Segment Elevation Myocardial Infarction.,"OBJECTIVES


The aim of the present study was to determine the effect of a delayed versus an immediate invasive approach on final infarct size and clinical outcome up to 1 year.
BACKGROUND


Up to 24% of patients with acute coronary syndromes present with ST-segment elevation myocardial infarction (STEMI) but show complete resolution of ST-segment elevation and symptoms before revascularization. Current guidelines do not clearly state whether these patients with transient STEMI should be treated with a STEMI-like or non-ST-segment elevation acute coronary syndrome-like intervention strategy.
METHODS


In this multicenter trial, 142 patients with transient STEMI were randomized 1:1 to either delayed or immediate coronary intervention. Cardiac magnetic resonance imaging was performed at 4 days and at 4-month follow-up to assess infarct size and myocardial function. Clinical follow-up was performed at 4 and 12 months.
RESULTS


In the delayed (22.7 h) and the immediate (0.4 h) invasive groups, final infarct size as a percentage of the left ventricle was very small (0.4% [interquartile range: 0.0% to 2.5%] vs. 0.4% [interquartile range: 0.0% to 3.5%]; p = 0.79), and left ventricular function was good (mean ejection fraction 59.3 ± 6.5% vs. 59.9 ± 5.4%; p = 0.63). In addition, the overall occurrence of major adverse cardiac events, consisting of death, recurrent infarction, and target lesion revascularization, up to 1 year was low and not different between both groups (5.7% vs. 4.4%, respectively; p = 1.00).
CONCLUSIONS


At follow-up, patients with transient STEMI have limited infarction and well-preserved myocardial function in general, and delayed or immediate revascularization has no effect on functional outcome and clinical events up to 1 year.",2019,"In addition, the overall occurrence of major adverse cardiac events, consisting of death, recurrent infarction, and target lesion revascularization, up to 1 year was low and not different between both groups (5.7% vs. 4.4%, respectively; p = 1.00).
","['patients with acute coronary syndromes present with ST-segment elevation myocardial infarction (STEMI', 'Patients With Transient ST-Segment Elevation Myocardial Infarction', '142 patients with transient STEMI']","['delayed or immediate coronary intervention', 'Cardiac magnetic resonance imaging', 'Delayed Versus Immediate Intervention']","['infarct size and myocardial function', 'overall occurrence of major adverse cardiac events, consisting of death, recurrent infarction, and target lesion revascularization', 'left ventricular function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}]",142.0,0.0882585,"In addition, the overall occurrence of major adverse cardiac events, consisting of death, recurrent infarction, and target lesion revascularization, up to 1 year was low and not different between both groups (5.7% vs. 4.4%, respectively; p = 1.00).
","[{'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Everaars', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Koen M J', 'Initials': 'KMJ', 'LastName': 'Marques', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Maarten A H', 'Initials': 'MAH', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Yolande', 'Initials': 'Y', 'LastName': 'Appelman', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels J W', 'Initials': 'NJW', 'LastName': 'Verouden', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelis P', 'Initials': 'CP', 'LastName': 'Allaart', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Stijn L', 'Initials': 'SL', 'LastName': 'Brinckman', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Blaricum, the Netherlands.'}, {'ForeName': 'Colette E', 'Initials': 'CE', 'LastName': 'Saraber', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Blaricum, the Netherlands.'}, {'ForeName': 'Koos J', 'Initials': 'KJ', 'LastName': 'Plomp', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Blaricum, the Netherlands.'}, {'ForeName': 'Jorik R', 'Initials': 'JR', 'LastName': 'Timmer', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Schaap', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Arno P', 'Initials': 'AP', 'LastName': 'van der Weerdt', 'Affiliation': 'Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: niels.vanroyen@radboudumc.nl.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.07.018']
646,31026713,Increasing substance use disorder counselors' self-efficacy and skills in talking to patients about sex and HIV risk: A randomized training trial.,"BACKGROUND


People with substance use disorder (SUD) experience increased risk for HIV, Hepatitis C, and sexually transmitted illnesses via risky sex. This high-risk population would benefit from sexual risk reduction interventions integrated into SUD treatment. However, many SUD counselors report lack of skill or confidence in addressing sexual risk with patients.
METHODS


This study was part of a larger nested 2 × 2 factorial repeated measures design, which compared two levels of counselor training (Basic-2 h versus Enhanced-10 h plus ongoing coaching). We determined whether counselors receiving Enhanced training addressing their motivation, confidence and skills (a) increased knowledge about sexual issues; (b) increased self-efficacy to discuss sex with patients; and (c) improved skills in discussing sex as part of SUD treatment, compared with those receiving shorter information-based training. Counselors providing individual therapy at two opioid treatment programs (OTP) and two psychosocial outpatient programs in the United States were eligible. Randomization occurred after Basic training. Measures included self-report (self-efficacy and knowledge) and blinded coding of standardized patient interviews (skill).
RESULTS


Counselors receiving Enhanced training (n = 28) showed significant improvements compared to their Basic training counterparts (n = 32) in self-efficacy, use of reflections, and use of decision-making and communication strategies with standardized patients. These improvements were maintained from post-training to 3-month follow-up. No adverse effects of study participation were reported.
CONCLUSIONS


Results suggest that counselors can improve their knowledge, self-efficacy and skill related to sexual risk conversations with patients based on modest skills-based training.",2019,"We determined whether counselors receiving Enhanced training addressing their motivation, confidence and skills (a) increased knowledge about sexual issues; (b) increased self-efficacy to discuss sex with patients; and (c) improved skills in discussing sex as part of SUD treatment, compared with those receiving shorter information-based training.","['Counselors providing individual therapy at two opioid treatment programs (OTP) and two psychosocial outpatient programs in the United States were eligible', 'People with substance use disorder (SUD) experience increased risk for HIV, Hepatitis C, and sexually transmitted illnesses via risky sex', 'patients about sex and HIV risk']",['counselor training (Basic-2\u2009h versus Enhanced-10\u2009h plus ongoing coaching'],"['self-report (self-efficacy and knowledge) and blinded coding of standardized patient interviews (skill', 'knowledge, self-efficacy and skill related to sexual risk conversations', 'self-efficacy, use of reflections, and use of decision-making and communication strategies', 'knowledge about sexual issues; (b) increased self-efficacy']","[{'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0180655,"We determined whether counselors receiving Enhanced training addressing their motivation, confidence and skills (a) increased knowledge about sexual issues; (b) increased self-efficacy to discuss sex with patients; and (c) improved skills in discussing sex as part of SUD treatment, compared with those receiving shorter information-based training.","[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Hatch-Maillette', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA; Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, 1959 NE Pacific St., Seattle, WA, 98105, USA. Electronic address: hatchm@uw.edu.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Harwick', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Baer', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA; VA Puget Sound Healthcare System-Seattle Division, 1660 S. Columbian Way, Seattle, WA, 98108, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Wells', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA; Emeritus, University of Washington School of Social Work, 4101 15th Ave NE, Seattle, WA, 98105, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Masters', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA.'}, {'ForeName': 'Audra', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychology, University of Washington, 119A Guthrie Hall Box 351525, Seattle, WA, 98195, USA.'}, {'ForeName': 'Kasie', 'Initials': 'K', 'LastName': 'Cloud', 'Affiliation': 'CODA, Inc., 1027 E. Burnside St., Portland, OR, 97214, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Peavy', 'Affiliation': 'Evergreen Treatment Services, 1700 Airport Way South, Seattle, WA, 98134, USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wiest', 'Affiliation': 'CODA, Inc., 1027 E. Burnside St., Portland, OR, 97214, USA.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Dillon', 'Affiliation': 'CODA, Inc., 1027 E. Burnside St., Portland, OR, 97214, USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Beadnell', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, 1107 NE 45th St., Suite 120, Seattle, WA, 98105, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.02.023']
647,31748427,Changeover Trial of Febuxostat and Topiroxostat for Hyperuricemia with Cardiovascular Disease: Sub-Analysis for Chronic Kidney Disease (TROFEO CKD Trial).,"BACKGROUND


The TROFEO trial demonstrated that febuxostat causes greater and more rapid reduction of serum uric acid (s-UA) than topiroxostat. We compared these drugs in patients with chronic kidney disease (CKD) by sub-analysis of the TROFEO trial.
METHODS


This sub-analysis targeted patients with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m 2 . The primary endpoint was the s-UA level. Secondary endpoints included creatinine, eGFR, urinary albumin, cystatin-C, oxidized low-density lipoprotein (Ox-LDL), eicosapentaenoic acid/arachidonic acid ratio, lipid biomarkers, high-sensitivity C-reactive protein, and B-type natriuretic peptide (BNP).
RESULTS


There was no significant difference of s-UA between the two groups either before or after treatment. However, s-UA did not exceed 6.0 mg/dL in febuxostat group during the study period, but it exceeded this level in seven patients from topiroxostat group, with the number being significantly higher in topiroxostat group. Serum creatinine (s-Cr) and eGFR were significantly better after 6 months of febuxostat treatment compared with topiroxostat Cystatin-C was significantly lower after 6 months of febuxostat treatment compared with topiroxostat. The Ox-LDL was significantly lower after 3 and 6 months of febuxostat treatment compared with topiroxostat.
CONCLUSION


Febuxostat had stronger renoprotective and antioxidant effects than topiroxostat in patients with hyperuricemia and CKD.",2020,"The Ox-LDL was significantly lower after 3 and 6 months of febuxostat treatment compared with topiroxostat.
","['patients with an estimated glomerular filtration rate (eGFR) ≤60', 'Hyperuricemia with Cardiovascular Disease', 'patients with hyperuricemia and CKD', 'patients with chronic kidney disease (CKD) by sub-analysis of the TROFEO trial']","['febuxostat', 'Febuxostat', 'Febuxostat and Topiroxostat']","['s-UA', 'renoprotective and antioxidant effects', 'Serum creatinine (s-Cr) and eGFR', 'Ox-LDL', 'creatinine, eGFR, urinary albumin, cystatin-C, oxidized low-density lipoprotein (Ox-LDL), eicosapentaenoic acid/arachidonic acid ratio, lipid biomarkers, high-sensitivity C-reactive protein, and B-type natriuretic peptide (BNP', 's-UA level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3811844'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C4049065', 'cui_str': 'topiroxostat'}]","[{'cui': 'C3179302', 'cui_str': 'Anti-Oxidant Effects'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.121033,"The Ox-LDL was significantly lower after 3 and 6 months of febuxostat treatment compared with topiroxostat.
","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sezai', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Unosawa', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Taoka', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Osaka', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisakuni', 'Initials': 'H', 'LastName': 'Sekino', 'Affiliation': 'Department of Cardiovascular Surgery, Sekino Hospital, Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}]",Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia,['10.5761/atcs.oa.19-00162']
648,31145222,Effect of a Dynamic Exercise Program in Combination With Mediterranean Diet on Quality of Life in Women With Rheumatoid Arthritis.,"OBJECTIVE


To assess the effect of a dynamic exercise program (DEP) in combination with a Mediterranean diet (MD) on health-related quality of life in women with rheumatoid arthritis (RA).
METHOD


A randomized clinical trial including 144 women with RA diagnosis was performed. Patients were randomized into 4 groups: (1) MD + DEP (n = 36), (2) DEP (n = 37), (3) MD (n = 40), and (4) control (n = 31). All patients received conventional disease-modifying antirheumatic drugs. Health-related quality of life was assessed with 36-item Short Form Health Survey v2 (0-100 score) and disability with Health Assessment Questionnaire Disability Index at enrollment and after 24 weeks. Between-groups comparisons of the change in the quality of life scores from baseline to follow-up were performed using analysis of covariance in which baseline-to-follow-up was the dependent variable, and the intervention group was the independent variable.
RESULTS


All patients had low disease activity at the time of enrollment, with a mean 28-joint Disease Activity Score of less than 3.2. Patients who were included in the MD + DEP and DEP groups showed 15 points of increase in health-related quality of life global punctuation versus 3.5 in the MD group and -4.6 in the control group (p = 0.01). Also the scores in the physical component after 24 weeks of intervention in the MD + DEP group improved (15.5), in the DEP group (12) and MD group as well (5.1), whereas the control group showed a decrease of the score (-1.7) (p = 0.03 between groups).
CONCLUSIONS


The combination of MD + DEP could improve the quality of life in RA patients with low disease activity receiving conventional disease-modifying antirheumatic drugs.",2020,"Also the scores in the physical component after 24 weeks of intervention in the MD + DEP group improved (15.5), in the DEP group (12) and MD group as well (5.1), whereas the control group showed a decrease of the score (-1.7) (p = 0.03 between groups).
","['144 women with RA diagnosis was performed', 'RA patients with low disease activity receiving conventional disease-modifying antirheumatic drugs', 'women with rheumatoid arthritis (RA', 'Women With Rheumatoid Arthritis']","['Mediterranean Diet', 'conventional disease-modifying antirheumatic drugs', 'MD + DEP', 'dynamic exercise program (DEP', 'Dynamic Exercise Program', 'Mediterranean diet (MD', 'DEP']","['quality of life scores', 'Quality of Life', 'low disease activity', 'health-related quality of life global punctuation', 'Health-related quality of life', 'disability with Health Assessment Questionnaire Disability Index', 'quality of life', 'health-related quality of life', 'mean 28-joint Disease Activity Score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}]",144.0,0.104662,"Also the scores in the physical component after 24 weeks of intervention in the MD + DEP group improved (15.5), in the DEP group (12) and MD group as well (5.1), whereas the control group showed a decrease of the score (-1.7) (p = 0.03 between groups).
","[{'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'García-Morales', 'Affiliation': 'From the Physioteraphy Service.'}, {'ForeName': 'Mariel', 'Initials': 'M', 'LastName': 'Lozada-Mellado', 'Affiliation': 'Departments of Clinical Nutrition.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hinojosa-Azaola', 'Affiliation': 'Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Llorente', 'Affiliation': 'Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Ogata-Medel', 'Affiliation': 'Departments of Clinical Nutrition.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Pineda-Juárez', 'Affiliation': 'Research Coordination, Centro Médico Nacional 20 de Noviembre, Ciudad de México, México.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Alcocer-Varela', 'Affiliation': 'Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Cervantes-Gaytán', 'Affiliation': 'From the Physioteraphy Service.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Castillo-Martínez', 'Affiliation': 'Departments of Clinical Nutrition.'}]",Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases,['10.1097/RHU.0000000000001064']
649,31753895,"Efficacy of  Bifidobacterium longum, B. infantis and Lactobacillus acidophilus  probiotics to prevent gut dysbiosis in preterm infants of 28+0-32+6 weeks of gestation: a randomised, placebo-controlled, double-blind, multicentre trial: the PRIMAL Clinical Study protocol.","INTRODUCTION


The healthy 'eubiosis' microbiome in infancy is regarded as the microbiome derived from term, vaginally delivered, antibiotic free, breastfed infants at 4-6 months. Dysbiosis is regarded as a deviation from a healthy state with reduced microbial diversity and deficient capacity to control drug-resistant organisms. Preterm infants are highly sensitive to early gut dysbiosis. Latter has been associated with sepsis and necrotising enterocolitis, but may also contribute to long-term health problems. Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
METHODS AND ANALYSIS


A randomised, double blind, placebo-controlled study has been designed to assess the safety and efficacy of the probiotic mix of  Bifidobacterium longum  and  infantis  and  Lactobacillus acidophilus  in the prevention of gut dysbiosis in preterm infants between 28+0 and 32+6 weeks of gestation. The study is conducted in 18 German neonatal intensive care units. Between April 2018 and March 2020, 654 preterm infants of 28+0-32+6 weeks of gestation will be randomised in the first 48 hours of life to 28 days of once daily treatment with either probiotics or placebo. The efficacy endpoint is the prevention of gut dysbiosis at day 30 of life. A compound definition of gut dysbosis is used: (1) colonisation with multidrug-resistant organisms or gram-negative bacteria with high epidemic potential or (2) a significant deviation of the gut microbiota composition as compared with healthy term infants. Dysbiosis is determined by (1) conventional microbiological culture and (2) phylogenetic microbiome analysis by high-throughput 16S rRNA and metagenome sequencing. Persistence of dysbiosis will be assessed at 12-month follow-up visits. Side effects and adverse events related to the intervention will be recorded. Key secondary endpoint(s) are putative consequences of dysbiosis. A subgroup of infants will be thoroughly phenotyped for immune parameters using chipcytometry.
ETHICS AND DISSEMINATION


Ethics approval was obtained in all participating sites. Results of the trial will be published in peer-review journals, at scientific meetings, on the website (www.primal-study.de) and via social media of parent organisations.
TRIAL REGISTRATION NUMBER


DRKS00013197; Pre-results.",2019,"Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
","['Preterm infants', 'preterm infants between 28+0\u2009and 32+6 weeks of gestation', 'preterm infants of 28+0-32+6 weeks of gestation', 'Between April 2018 and March 2020, 654 preterm infants of 28+0-32+6 weeks of gestation', '18 German neonatal intensive care units', 'healthy term infants']","['placebo', 'Bifidobacterium longum, B. infantis and Lactobacillus acidophilus  probiotics', 'probiotics or placebo']","['safety and efficacy', 'Side effects and adverse events']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",654.0,0.386743,"Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.
","[{'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Marißen', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haiß', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Department of Paediatrics, University Medical Centre, Mainz, Germany.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Van Rossum', 'Affiliation': 'Structural and Computational Biology Unit, European Molecular Biology Laboratory, Heidelberg, Germany.'}, {'ForeName': 'Lisa Marie', 'Initials': 'LM', 'LastName': 'Bünte', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Frommhold', 'Affiliation': ""Children's Hospital Memmingen, Memmingen, Germany.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gille', 'Affiliation': 'Department of Neonatology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Sybelle', 'Initials': 'S', 'LastName': 'Goedicke-Fritz', 'Affiliation': 'Department of General Paediatrics and Neonatology, Saarland University, Homburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Göpel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Hudalla', 'Affiliation': 'Department of Neonatology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pagel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Pirr', 'Affiliation': 'Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Siller', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Dorothee', 'Initials': 'D', 'LastName': 'Viemann', 'Affiliation': 'Department of Paediatric Pneumology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Vens', 'Affiliation': 'Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Inke', 'Initials': 'I', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Herting', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zemlin', 'Affiliation': 'Department of General Paediatrics and Neonatology, Saarland University, Homburg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Gehring', 'Affiliation': 'Department of Paediatrics, University Medical Centre, Mainz, Germany.'}, {'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Bork', 'Affiliation': 'Structural and Computational Biology Unit, European Molecular Biology Laboratory, Heidelberg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Henneke', 'Affiliation': 'Insitute for Immunodeficiency (CCI) and Centre for Paediatrics and Adolescent Medicine, Medical Centre and Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Härtel', 'Affiliation': 'Department of Paediatrics, University of Lübeck, Lübeck, Germany christoph.haertel@uksh.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-032617']
650,31133501,"Variations in Irisin, Bone Mineral Density, Bone Mineral Content, and Body Composition After Laparoscopic Bariatric Procedures in Obese Adults.","INTRODUCTION


This study was aimed to assess irisin levels in obesity (OB) and T2DM individuals and investigate the dynamic changes of irisin, bone mineral density (BMD), bone mineral content, and body composition in 19 OB patients after laparoscopic bariatric procedures, and also to evaluate the correlation of irisin, with BMD and body composition.
METHODS


Forty-five OB, 20 T2DM, and 20 healthy adults had been recruited. Levels of irisin were measured in all subjects. Metabolic characteristics were obtained from OB and T2DM patients. Nineteen patients were randomly assigned to be received Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) procedure and to be completed 6-month follow-up. Irisin, BMD, bone mineral content, and body composition were measured at each visit.
RESULTS


Significantly higher circulating irisin levels were measured in the OB group compared with T2DM and control groups. FINS, C-P, HOMA-IR, FBCI, HBCI, ALT, AST, and UA levels of OB were significantly higher than those of T2DM patients. While FBG and HbA1c of the OB were significantly lower than T2DM group. There were significant differences among circulating irisin, BMD, and body composition after laparoscopic bariatric surgery. Levels of irisin were decreased after operations including both LRYGB and LSG surgery compared with preoperation. At each time point (1, 3, and 6 months) of postoperation, there was no significant difference in percentage of total weight loss between LSG and LRYGB group. The positive correlation of irisin levels with total BMD, muscle, and fat masses were found during 6-month follow-up after surgery.
CONCLUSIONS


The levels of irisin were higher in OB patients. There were positive correlations of irisin levels with total BMD, muscle, and fat masses during 6-month follow-up after surgery. Irisin may be involved in the occurrence and development of obese and it is related to BMD and body composition. Both LRYGB and LSG operations could decrease the circulating levels of irisin.",2020,"FINS, C-P, HOMA-IR, FBCI, HBCI, ALT, AST, and UA levels of OB were significantly higher than those of T2DM patients.","['19 OB patients after laparoscopic bariatric procedures', 'Forty-five OB, 20 T2DM, and 20 healthy adults had been recruited', 'Nineteen patients', 'Obese Adults']","['Roux-en-Y gastric bypass (LRYGB) or laparoscopic', 'sleeve gastrectomy (LSG) procedure', 'T2DM']","['irisin levels with total BMD, muscle, and fat masses', 'Irisin, BMD, bone mineral content, and body composition', 'levels of irisin', 'FBG and HbA1c of the OB', 'Metabolic characteristics', 'Variations in Irisin, Bone Mineral Density, Bone Mineral Content, and Body Composition', 'FINS, C-P, HOMA-IR, FBCI, HBCI, ALT, AST, and UA levels of OB', 'irisin levels', 'irisin, bone mineral density (BMD), bone mineral content, and body composition', 'total weight loss', 'circulating levels of irisin', 'circulating irisin levels', 'Levels of irisin', 'circulating irisin, BMD, and body composition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",19.0,0.0220558,"FINS, C-P, HOMA-IR, FBCI, HBCI, ALT, AST, and UA levels of OB were significantly higher than those of T2DM patients.","[{'ForeName': 'Chunting', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Science and Education Office, The First Affiliated Hospital, Jinan University, Guangzhou, China.'}, {'ForeName': 'Zejian', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Medical Centre of Stomatology, The First Affiliated Hospital, Jinan University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, The First Affiliated Hospital, Jinan University, Guangzhou, China.'}, {'ForeName': 'Lie', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital, Jinan University, Guangzhou, China.'}, {'ForeName': 'Cunchuan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital, Jinan University, Guangzhou, China. Electronic address: twcc@jnu.edu.cn.'}, {'ForeName': 'Qiping', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital, Jinan University, Guangzhou, China. Electronic address: qiping.shi@qq.com.'}]",Journal of clinical densitometry : the official journal of the International Society for Clinical Densitometry,['10.1016/j.jocd.2019.05.002']
651,31132509,Sessions of Prolonged Continuous Theta Burst Stimulation or High-frequency 10 Hz Stimulation to Left Dorsolateral Prefrontal Cortex for 3 Days Decreased Pain Sensitivity by Modulation of the Efficacy of Conditioned Pain Modulation.,"The 10 Hz repetitive transcranial magnetic stimulation (10 Hz-rTMS) to the left dorsolateral prefrontal cortex produces analgesia, probably by activating the pain modulation system. A newer rTMS paradigm, called theta burst stimulation (TBS), has been developed. Unlike 10 Hz-rTMS, prolonged continuous TBS (pcTBS) mimics endogenous theta rhythms, which can improve induction of synaptic long-term potentiation. Therefore, this study investigated whether pcTBS to the left dorsolateral prefrontal cortex reduced pain sensitivity more efficiently compared with 10 Hz-rTMS, the analgesic effects lasted beyond the stimulation period, and the reduced pain sensitivity was associated with increased efficacy of conditioned pain modulation (CPM) and/or intracortical excitability. Sixteen subjects participated in a randomized cross-over study with pcTBS and 10 Hz-rTMS. Pain thresholds to heat (HPT), cold, pressure (PPT), intracortical excitability assessment, and CPM with mechanical and heat supra-pain threshold test stimuli and the cold pressor test as conditioning were collected before (Baseline), 3 (Day3) and 4 days (Day4) after 3-day session of rTMS. HPTs and PPTs increased with 10 Hz-rTMS and pcTBS at Day3 and Day4 compared with Baseline (P = .007). Based on pooled data from pcTBS and 10 Hz-rTMS, the increased PPTs correlated with increased efficacy of CPM at Day3 (P = .008), while no correlations were found at Day4 or with the intracortical excitability. PERSPECTIVE: Preliminary results of this comparative study did not show stronger pain sensitivity reduction by pcTBS compared with 10 Hz-rTMS to the L-DPFC. Both protocols maintained increased pain thresholds up to 24-hours after the last session, which were partially associated with modulation of CPM efficacy but not with the intracortical excitability changes.",2019,"Pain thresholds to heat (HPT), cold (CPT), pressure (PPT), intra-cortical excitability assessment, and CPM with mechanical and heat supra-pain threshold test stimuli and the cold pressor test as conditioning were collected before (Baseline), 3 (Day3) and 4 days (Day4) after 3-day session of rTMS.",['Sixteen subjects participated in a randomized cross-over study with'],"['10Hz-rTMS', 'pcTBS and 10Hz-rTMS', 'Unlike 10Hz-rTMS, prolonged continuous TBS (pcTBS', '10Hz repetitive transcranial magnetic stimulation (10Hz-rTMS']","['pain sensitivity reduction', 'pain sensitivity', 'pain thresholds', 'HPTs and PPTs', 'Pain thresholds to heat (HPT), cold (CPT), pressure (PPT), intra-cortical excitability assessment, and CPM with mechanical and heat supra-pain threshold test stimuli and the cold pressor test as conditioning', 'CPM efficacy', 'efficacy of conditioned pain modulation (CPM) and/or intra-cortical excitability']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0392412', 'cui_str': 'cpm'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",16.0,0.0302644,"Pain thresholds to heat (HPT), cold (CPT), pressure (PPT), intra-cortical excitability assessment, and CPM with mechanical and heat supra-pain threshold test stimuli and the cold pressor test as conditioning were collected before (Baseline), 3 (Day3) and 4 days (Day4) after 3-day session of rTMS.","[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'De Martino', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Ana Mércia', 'Initials': 'AM', 'LastName': 'Fernandes', 'Affiliation': 'Pain Center, LIM-62, Department of Neurology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Galhardoni', 'Affiliation': 'Pain Center, LIM-62, Department of Neurology, University of São Paulo, São Paulo, Brazil; Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neuroscience (LIM27) and National Institute of Biomarkers in Neuropsychiatry (INBioN), Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil; School of Medicine, University of City of São Paulo (UNICID), São Paulo, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'De Oliveira Souza', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, Hospital das Clinicas of the University of São Paulo School of Medicine, São Paulo, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ciampi De Andrade', 'Affiliation': 'Pain Center, LIM-62, Department of Neurology, University of São Paulo, São Paulo, Brazil; Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neuroscience (LIM27) and National Institute of Biomarkers in Neuropsychiatry (INBioN), Department and Institute of Psychiatry, University of São Paulo School of Medicine, São Paulo, Brazil; Pain Center, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark. Electronic address: tgn@hst.aau.dk.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.05.010']
652,31548244,Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial.,"OBJECTIVE


In type 2 diabetes, insulin resistance and progressive β-cell failure require treatment with high insulin doses, leading to weight gain. Our aim was to study whether a three-meal diet (3Mdiet) with a carbohydrate-rich breakfast may upregulate clock gene expression and, as a result, allow dose reduction of insulin, leading to weight loss and better glycemic control compared with an isocaloric six-meal diet (6Mdiet).
RESEARCH DESIGN AND METHODS


Twenty-eight volunteers with diabetes (BMI 32.4 ± 5.2 kg/m 2  and HbA 1c  8.1 ± 1.1% [64.5 ± 11.9 mmol/mol]) were randomly assigned to 3Mdiet or 6Mdiet. Body weight, glycemic control, continuous glucose monitoring (CGM), appetite, and clock gene expression were assessed at baseline, after 2 weeks, and after 12 weeks.
RESULTS


3Mdiet, but not 6Mdiet, led to a significant weight loss (-5.4 ± 0.9 kg) ( P  < 0.01) and decreased HbA 1c  (-12 mmol/mol [-1.2%]) ( P  < 0.0001) after 12 weeks. Fasting glucose and daily and nocturnal glucose levels were significantly lower on the 3Mdiet. CGM showed a significant decrease in the time spent in hyperglycemia only on the 3Mdiet. Total daily insulin dose was significantly reduced by 26 ± 7 units only on the 3Mdiet. There was a significant decrease in the hunger and cravings only in the 3Mdiet group. Clock genes exhibited oscillation, increased expression, and higher amplitude on the 3Mdiet compared with the 6Mdiet.
CONCLUSIONS


A 3Mdiet, in contrast to an isocaloric 6Mdiet, leads to weight loss and significant reduction in HbA 1c , appetite, and overall glycemia, with a decrease in daily insulin. Upregulation of clock genes seen in this diet intervention could contribute to the improved glucose metabolism.",2019,Fasting glucose and daily and nocturnal glucose levels were significantly lower on the 3Mdiet.,"['Twenty-eight volunteers with diabetes (BMI 32.4 ± 5.2 kg/m 2  and HbA 1c  8.1 ± 1.1% [64.5 ± 11.9 mmol/mol', 'Patients With Type']","['3Mdiet or 6Mdiet', 'isocaloric six-meal diet (6Mdiet', 'meal diet (3Mdiet) with a carbohydrate-rich breakfast', 'CGM']","['time spent in hyperglycemia', 'weight loss, significant reduction in HbA 1c , appetite, and overall glycemia', 'Body weight, glycemic control, continuous glucose monitoring (CGM), appetite, and clock gene expression', 'glucose metabolism', 'Fasting glucose and daily and nocturnal glucose levels', 'Total daily insulin dose', 'hunger and cravings', 'weight loss', 'daily insulin', 'Glycated Hemoglobin and Daily Insulin Dose']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",28.0,0.0205284,Fasting glucose and daily and nocturnal glucose levels were significantly lower on the 3Mdiet.,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Jakubowicz', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel daniela.jak@gmail.com.'}, {'ForeName': 'Zohar', 'Initials': 'Z', 'LastName': 'Landau', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Tsameret', 'Affiliation': 'Institute of Biochemistry, Food Science and Nutrition, The Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Rehovot, Israel.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Wainstein', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Department of Internal Medicine, Hadassah Hebrew University Hospital, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Ahren', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Chapnik', 'Affiliation': 'Institute of Biochemistry, Food Science and Nutrition, The Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Rehovot, Israel.'}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Barnea', 'Affiliation': 'Department of Molecular Genetics, Faculty of Biochemistry, Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Ganz', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Menaged', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Mor', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Yosefa', 'Initials': 'Y', 'LastName': 'Bar-Dayan', 'Affiliation': 'Diabetes Unit, Wolfson Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Holon, Israel.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Froy', 'Affiliation': 'Institute of Biochemistry, Food Science and Nutrition, The Robert H. Smith Faculty of Agriculture, Food and Environment, The Hebrew University of Jerusalem, Rehovot, Israel oren.froy@mail.huji.ac.il.'}]",Diabetes care,['10.2337/dc19-1142']
653,30893230,Postoperative Mobilization After Superior Rotator Cuff Repair: Sling Versus No Sling: A Randomized Prospective Study.,"BACKGROUND


Patients are commonly advised to wear a sling for 4 to 6 weeks after rotator cuff repair despite negative effects of early immobilization and benefits of motion rehabilitation. The aim of this study was to compare clinical and radiographic outcomes up to 6 months following rotator cuff repair with and without postoperative sling immobilization.
METHODS


We randomized 80 patients scheduled for arthroscopic repair of a small or medium superior rotator cuff tear into sling and no-sling groups (40 patients each). Passive mobilization was performed in both groups during the first 4 postoperative weeks, and this was followed by progressive active mobilization. Patients were evaluated clinically at 10 days and 1.5, 3, and 6 months and using ultrasound at 6 months. Univariable and multivariable analyses were performed to determine if postoperative scores were associated with sex, age at surgery, immobilization, arm dominance, a biceps procedure, resection of the distal part of the clavicle, or preoperative scores.
RESULTS


The sling and no-sling groups had similar preoperative patient characteristics, function, and adjuvant procedures. At 10 days, there was no difference in pain between the 2 groups (mean pain score [and standard deviation], 5.2 ± 2.3 versus 5.2 ± 1.9, p = 0.996). In comparison with the sling group, the no-sling group showed greater mean external rotation (23.5° ± 15.6° versus 15.3° ± 14.6°, p = 0.017) and active elevation (110.9° ± 31.9° versus 97.0° ± 25.0°, p = 0.038) at 1.5 months as well as better mean active elevation (139.0° ± 24.7° versus 125.8° ± 24.4°, p = 0.015) and internal rotation (T12 or above in 50% versus 28%, p = 0.011) at 3 months. Ultrasound evaluation revealed no significant differences at 6 months in tendon thickness anteriorly (p = 0.472) or posteriorly (p = 0.639), bursitis (p = 1.000), echogenicity (p = 0.422), or repair integrity (p = 0.902). Multivariable analyses confirmed that the mean American Shoulder and Elbow Surgeons (ASES) score increased with patient age (beta, 0.60; p = 0.009), the Single Assessment Numeric Evaluation (SANE) decreased with sling immobilization (beta, -6.33; p = 0.014), and pain increased with sling immobilization (beta, 0.77; p = 0.022).
CONCLUSIONS


No immobilization after rotator cuff repair is associated with better early mobility and functional scores in comparison with sling immobilization. Postoperative immobilization with a sling may therefore not be required for patients treated for a small or medium tendon tear.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"Ultrasound evaluation revealed no significant differences at 6 months in tendon thickness anteriorly (p = 0.472) or posteriorly (p = 0.639), bursitis (p = 1.000), echogenicity (p = 0.422), or repair integrity (p = 0.902).","['80 patients scheduled for', 'groups (40 patients each']","['rotator cuff repair with and without postoperative sling immobilization', 'Superior Rotator Cuff Repair', 'Sling', 'arthroscopic repair of a small or medium superior rotator cuff tear into sling and no-sling']","['Single Assessment Numeric Evaluation (SANE', 'pain', 'mean active elevation', 'mean external rotation', 'bursitis', 'active elevation', 'echogenicity', 'early mobility and functional scores', 'mean American Shoulder and Elbow Surgeons (ASES) score', 'tendon thickness anteriorly', 'repair integrity', 'internal rotation', 'Postoperative Mobilization', 'Passive mobilization']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0006444', 'cui_str': 'Bursitis'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}]",80.0,0.105807,"Ultrasound evaluation revealed no significant differences at 6 months in tendon thickness anteriorly (p = 0.472) or posteriorly (p = 0.639), bursitis (p = 1.000), echogenicity (p = 0.422), or repair integrity (p = 0.902).","[{'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Tirefort', 'Affiliation': 'Division of Orthopaedics and Trauma Service, University Hospitals of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Adrien J', 'Initials': 'AJ', 'LastName': 'Schwitzguebel', 'Affiliation': 'Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Meyrin, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Collin', 'Affiliation': 'Centre Hospitalier Prive[Combining Acute Accent] Saint-Gre[Combining Acute Accent]goire (Vivalto Sante[Combining Acute Accent]), Saint-Gre[Combining Acute Accent]goire, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Nowak', 'Affiliation': 'Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Meyrin, Switzerland.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Plomb-Holmes', 'Affiliation': 'Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Meyrin, Switzerland.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lädermann', 'Affiliation': 'Division of Orthopaedics and Trauma Service, University Hospitals of Geneva, Geneva, Switzerland.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.18.00773']
654,31140402,Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT.,"BACKGROUND


Venous ulceration is a common and costly health-care issue worldwide, with poor healing rates greatly affecting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence, but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence; however, the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear.
OBJECTIVES


To determine the clinical effectiveness and cost-effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration.
DESIGN


A pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial with a health economic evaluation.
SETTING


Secondary care vascular centres in England.
PARTICIPANTS


Patients aged ≥ 18 years with a venous leg ulcer of between 6 weeks' and 6 months' duration and an ankle-brachial pressure index of ≥ 0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux.
INTERVENTIONS


Participants were randomised 1 : 1 to either early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed).
MAIN OUTCOME MEASURES


The primary outcome measure was time from randomisation to ulcer healing, confirmed by blinded assessment. Secondary outcomes included 24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs). All analyses were performed on an intention-to-treat basis.
RESULTS


A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation). Baseline characteristics were similar between the two groups. Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68;  p  = 0.001]. Median time to ulcer healing was 56 (95% CI 49 to 66) days in the early ablation group and 82 (95% CI 69 to 92) days in the deferred ablation group. The ulcer healing rate at 24 weeks was 85.6% in the early ablation group, compared with 76.3% in the deferred ablation group. Median ulcer-free time was 306 [interquartile range (IQR) 240-328] days in the early ablation group and 278 (IQR 175-324) days in the deferred endovenous ablation group ( p  = 0.002). The most common complications of superficial endovenous ablation were pain and deep-vein thrombosis. Differences in repeated measures of Aberdeen Varicose Vein Questionnaire scores ( p  < 0.001), EuroQol-5 Dimensions index values ( p  = 0.03) and Short Form questionnaire-36 items body pain ( p  = 0.05) over the follow-up period were observed, in favour of early ablation. The mean difference in total costs between the early ablation and deferred ablation groups was £163 [standard error (SE) £318;  p  = 0.607]; however, there was a substantial and statistically significant gain in QALY over 1 year [mean difference between groups 0.041 (SE 0.017) QALYs;  p  = 0.017]. The incremental cost-effectiveness ratio of early ablation at 1 year was £3976 per QALY, with a high probability (89%) of being more cost-effective than deferred ablation at conventional UK decision-making thresholds (currently £20,000 per QALY). Sensitivity analyses using alternative statistical models give qualitatively similar results.
LIMITATIONS


Only 7% of screened patients were recruited, treatment regimens varied significantly and technical success was assessed only in the early ablation group.
CONCLUSIONS


Early endovenous ablation of superficial venous reflux, in addition to compression therapy and wound dressings, reduces the time to healing of venous leg ulcers, increases ulcer-free time and is highly likely to be cost-effective.
FUTURE WORK


Longer-term follow-up is ongoing and will determine if early ablation will affect recurrence rates in the medium and long term.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN02335796.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 24. See the NIHR Journals Library website for further project information.",2019,"Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68;  p  = 0.001].","['Secondary care vascular centres in England', 'A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation', ""Patients aged ≥\u200918 years with a venous leg ulcer of between 6 weeks' and 6 months' duration and an ankle-brachial pressure index of ≥\u20090.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux"", 'patients with venous ulceration']","['compression therapy with deferred endovenous ablation', 'compression therapy with early endovenous ablation of superficial venous reflux', 'Compression bandaging', 'early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed', 'endovenous ablation of superficial venous reflux']","['Aberdeen Varicose Vein Questionnaire scores', 'ulcer healing rate', 'EuroQol-5 Dimensions index values', 'pain and deep-vein thrombosis', 'Median time to ulcer healing', 'total costs', '24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs', 'technical success', 'Time to ulcer healing', 'time from randomisation to ulcer healing', 'clinical effectiveness and cost-effectiveness', 'healing rates', 'questionnaire-36 items body pain', 'QALY', 'time to healing of venous leg ulcers', 'recurrence rates', 'incremental cost-effectiveness ratio of early ablation', 'Median ulcer-free time']","[{'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C2242647', 'cui_str': 'Endovenous ablation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1276055', 'cui_str': 'ABPI - Ankle brachial pressure index'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C0042344', 'cui_str': 'Venous Stasis Ulcers'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2242647', 'cui_str': 'Endovenous ablation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C1533146', 'cui_str': 'Compression bandaging'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}]","[{'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0023223', 'cui_str': 'Leg Ulcer'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",450.0,0.0803441,"Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68;  p  = 0.001].","[{'ForeName': 'Manjit S', 'Initials': 'MS', 'LastName': 'Gohel', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Heatley', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Xinxue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bulbulia', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Cullum', 'Affiliation': 'School of Health Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Epstein', 'Affiliation': 'Department of Applied Economics, University of Granada, Granada, Spain.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Nyamekye', 'Affiliation': 'Worcestershire Acute Hospitals NHS Trust, Worcester, UK.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Poskitt', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renton', 'Affiliation': 'North West London Hospitals NHS Trust, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Alun H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23240']
655,31586218,Nipple-Areola Complex Ischemia or Necrosis in Freestyle Perforator Flap Reduction Mammoplasty Operations.,"BACKGROUND


Necrosis of the nipple-areolar complex (NAC) is one of the most devastating complications of reduction mammoplasty. A variable, asymmetrical pattern of blood supply from the main sources was found in the same individual. To solve this problem, we present a method to be sure that the blood supply to the NAC is contained within the designed pedicle during reduction mammoplasty. This is done using the colored duplex scan and handheld Doppler to perform freestyle perforator flap reduction mammoplasty.
METHODS


This is a prospective randomized study that has been performed on 105 patients in the period between January 2014 and 2019 at the Plastic and Reconstructive Surgery Department, Tanta University Hospitals. Freestyle perforator flaps were performed for all cases after perforator detection using handheld Doppler and confirmed by colored duplex scan.
RESULTS


The procedure was performed as freestyle on medial perforators in 35 (33.3%) cases, on lateral perforators in 20 (19%) cases, on combined medial and lateral perforators, as a bipedicle in 30 (28.7%) cases, on upper pole perforators in 12 (11.4%) cases, and on lower pole perforators in 8 (7.6%) cases.
CONCLUSIONS


The use of handheld Doppler and the confirmation by duplex scan are mandatory to decrease the incidence of NAC necrosis or ischemia.
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine Ratings, please refer to Table of Contents or online Instructions to Authors www.springer.com/00266.",2019,"The procedure was performed as freestyle on medial perforators in 35 (33.3%) cases, on lateral perforators in 20 (19%) cases, on combined medial and lateral perforators, as a bipedicle in 30 (28.7%) cases, on upper pole perforators in 12 (11.4%) cases, and on lower pole perforators in 8 (7.6%) cases.
","['105 patients in the period between January 2014 and 2019 at the Plastic and Reconstructive Surgery Department, Tanta University Hospitals']","['handheld Doppler and the confirmation by duplex scan', 'IV']",[],"[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0444916', 'cui_str': 'Duplex (qualifier value)'}, {'cui': 'C0441633'}]",[],,0.0248469,"The procedure was performed as freestyle on medial perforators in 35 (33.3%) cases, on lateral perforators in 20 (19%) cases, on combined medial and lateral perforators, as a bipedicle in 30 (28.7%) cases, on upper pole perforators in 12 (11.4%) cases, and on lower pole perforators in 8 (7.6%) cases.
","[{'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Elmelegy', 'Affiliation': 'Department of Plastic Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt. naderelmelegy@gmail.com.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Shokr', 'Affiliation': 'Department of Plastic Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mamdouh', 'Initials': 'M', 'LastName': 'Osama', 'Affiliation': 'Department of Plastic Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01511-5']
656,30995176,"Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia.","PURPOSE


A randomized, double-blind, phase III study of idelalisib (IDELA) plus rituximab versus placebo plus rituximab in patients with relapsed chronic lymphocytic leukemia (CLL) was terminated early because of superior efficacy of the IDELA-plus-rituximab (IDELA/R) arm. Patients in either arm could then enroll in an extension study to receive IDELA monotherapy. Here, we report the long-term efficacy and safety data for IDELA-treated patients across the primary and extension studies.
PATIENTS AND METHODS


Patients were randomly assigned to receive rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo/R; n = 110). Key end points were progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety.
RESULTS


The long-term efficacy and safety of treatment with IDELA was assessed in 110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study. The IDELA/R-to-IDELA group had a median PFS of 20.3 months (95% CI, 17.3 to 26.3 months) after a median follow-up time of 18 months (range, 0.3 to 67.6 months). The ORR was 85.5% (94 of 110 patients; n = 1 complete response). The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively. Prolonged exposure to IDELA increased the incidence of all-grade, grade 2, and grade 3 or greater diarrhea (46.4%, 17.3%, and 16.4%, respectively), all-grade and grade 3 or greater colitis (10.9% and 8.2%, respectively) and all-grade and grade 3 or greater pneumonitis (10.0% and 6.4%, respectively) but did not increase the incidence of elevated hepatic aminotransferases.
CONCLUSION


IDELA improved PFS and OS compared with rituximab alone in patients with relapsed CLL. Long-term IDELA was effective and had an expected safety profile. No new IDELA-related adverse events were identified with longer exposure.",2019,"The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively.","['patients with relapsed chronic lymphocytic leukemia (CLL', 'Patients With Relapsed Chronic Lymphocytic Leukemia', 'Patients', '110 patients who received at least one dose of IDELA in the primary study, 75 of whom enrolled in the extension study', 'patients with relapsed CLL']","['IDELA', 'Rituximab With or Without Idelalisib', 'IDELA monotherapy', 'placebo plus rituximab', 'IDELA-plus-rituximab (IDELA/R', 'idelalisib (IDELA) plus rituximab', 'rituximab', 'rituximab in combination with either IDELA 150 mg twice daily (IDELA/R; n = 110) or placebo (placebo']","['PFS and OS', 'grade and grade 3 or greater colitis', 'pneumonitis', 'progression-free survival (PFS), overall response rate (ORR), overall survival (OS), and safety', 'diarrhea', 'median OS', 'ORR', 'median PFS', 'incidence of elevated hepatic aminotransferases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C3714636', 'cui_str': 'Pulmonary Inflammation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}]",110.0,0.412396,"The median OS was 40.6 months (95% CI, 28.5 to 57.3 months) and 34.6 months (95% CI, 16.0 months to not reached) for patients randomly assigned to the IDELA/R and placebo/R groups, respectively.","[{'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': '1 Willamette Valley Cancer Institute and Research Center, US Oncology Research, Springfield, OR.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': '2 Stanford School of Medicine, Stanford, CA.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': '3 Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': '4 Georgetown University Hospital, Washington DC.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pagel', 'Affiliation': '5 Swedish Cancer Institute, Seattle, WA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""6 St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': '7 Zucher School of Medicine at Hofstra/Northwell, New Hyde Park, NY.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Zelenetz', 'Affiliation': '8 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': '9 University of California, San Diego, Moores Cancer Center, La Jolla, CA.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': '10 Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': '11 Università Vita-Salute San Raffaele and Istituto Di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Eradat', 'Affiliation': '12 David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ervin', 'Affiliation': '13 Venice Regional Bayfront Health, Venice, FL.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lamanna', 'Affiliation': '14 Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Coiffier', 'Affiliation': '15 Centre Hospitalier Lyon-Sud, Pierre Benite, France.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Pettitt', 'Affiliation': '16 University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': '17 Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': '18 Ulm University, Ulm, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cramer', 'Affiliation': '19 University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': '20 Gilead Sciences, Foster City, CA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': '20 Gilead Sciences, Foster City, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': '19 University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': '21 University of California, Irvine, Orange, CA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': '18 Ulm University, Ulm, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01460']
657,31139911,"The Importance of Multiple, Different Rhinoplasty Consultations in Patient Selection.","OBJECTIVE


We aimed to investigate the relationship between the number of visits to different physicians and postoperative satisfaction in patients undergoing primary septorhinoplasty by using the ROE survey.
METHODS


Patients for whom we performed septorhinoplasty in the last 3 years were examined. Patients who visited 3 different physicians (including us) before the surgery were allocated to group 1. Patients who visited ≥ 4 physicians comprised group 2. We randomized 50 patients in each group. Rhinoplasty outcome evaluation (ROE) was performed twice for the preoperative evaluation and to determine the satisfaction in postoperative 6th month.
RESULTS


Preoperative and postoperative ROE values were significantly lower in group 2 (p < 0.001). ROE values after surgery were 82% in group 1 and 68.92% in group 2.
CONCLUSION


We think that it is more appropriate for patients who visit many surgeons to be evaluated more carefully and to be psychologically examined.
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2019,"RESULTS


Preoperative and postoperative ROE values were significantly lower in group 2 (p < 0.001).","['Patients who visited\u2009≥\u20094 physicians comprised group 2', 'Patients for whom we performed septorhinoplasty in the last 3\xa0years were examined', 'Patients who visited 3 different physicians (including us) before the surgery', 'patients undergoing primary septorhinoplasty by using the ROE survey']",['IV'],"['Preoperative and postoperative ROE values', 'ROE values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0189054', 'cui_str': 'Rhinoseptoplasty (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",50.0,0.0785768,"RESULTS


Preoperative and postoperative ROE values were significantly lower in group 2 (p < 0.001).","[{'ForeName': 'Zeynel Abidin', 'Initials': 'ZA', 'LastName': 'Erkan', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Çukurova State Hospital, Seyhan, Adana, Turkey.'}, {'ForeName': 'Sanem Okşan', 'Initials': 'SO', 'LastName': 'Erkan', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Adana City Education and Research Hospital, Health Science University, Yuregir, Adana, Turkey. zeynelabidinerkan@mynet.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01403-8']
658,31707732,Acute lower leg hot water immersion protects macrovascular dilator function following ischaemia-reperfusion injury in humans.,"NEW FINDINGS


• What is the central question of this study? What is the effect of lower leg hot water immersion on vascular ischaemia-reperfusion injury induced in the arm of young healthy humans? • What is the main finding and its importance? Lower leg hot water immersion successfully protects against vascular ischaemia-reperfusion injury in humans. This raises the possibility that targeted heating of the lower legs may be an alternative therapeutic approach to whole-body heating that is equally efficacious at protecting against vascular ischaemia-reperfusion injury.
ABSTRACT


Reperfusion that follows a period of ischaemia paradoxically reduces vasodilator function in humans and contributes to the tissue damage associated with an ischaemic event. Acute whole-body hot water immersion protects against vascular ischaemia-reperfusion (I-R) injury in young healthy humans. However, the effect of acute lower leg heating on I-R injury is unclear. Therefore, the purpose of this study was to test the hypothesis that, compared with thermoneutral control immersion, acute lower leg hot water immersion would prevent the decrease in macro- and microvascular dilator functions following I-R injury in young healthy humans. Ten young healthy subjects (5 female) immersed their lower legs into a circulated water bath for 60 min under two randomized conditions: (1) thermoneutral control immersion (∼33°C) and (2) hot water immersion (∼42°C). Macrovascular (brachial artery flow-mediated dilatation) and microvascular (forearm reactive hyperaemia) dilator functions were assessed using Doppler ultrasound at three time points: (1) pre-immersion, (2) 60 min post-immersion, and (3) post-I/R (20 min of arm ischaemia followed by 20 min of reperfusion). Ischaemia-reperfusion injury reduced macrovascular dilator function following control immersion (pre-immersion 6.0 ± 2.1% vs. post-I/R 3.6 ± 2.1%; P < 0.05), but was well-maintained with prior hot water immersion (pre-immersion 5.8 ± 2.1% vs. post-I/R 5.3 ± 2.1%; P = 0.8). Microvascular dilator function did not differ between conditions or across time. Taken together, acute lower leg hot water immersion prevents the decrease in macrovascular dilator function that occurs following I-R injury in young healthy humans.",2020,Macrovascular (brachial artery flow-mediated dilatation) and microvascular (forearm reactive hyperaemia) dilator functions were assessed using Doppler ultrasound at three time points: 1) pre-immersion; 2) 60 min post-immersion; 3) post-I/R (20 min of arm ischaemia followed by 20 min of reperfusion).,"['Ten young healthy subjects (5 female', 'young healthy humans', 'Ischaemia-Reperfusion Injury in Humans']","['Leg Hot Water Immersion', 'thermoneutral control immersion (∼33°C); 2) hot water immersion (∼42°C', 'lower leg hot water immersion']","['Macrovascular (brachial artery flow-mediated dilatation) and microvascular (forearm reactive hyperaemia) dilator functions', 'macro- and microvascular dilator functions', 'Microvascular dilator function', 'macrovascular dilator function']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-Reperfusion Injury'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0337023', 'cui_str': 'Hot water (substance)'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140621', 'cui_str': 'Leg'}]","[{'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",10.0,0.0252533,Macrovascular (brachial artery flow-mediated dilatation) and microvascular (forearm reactive hyperaemia) dilator functions were assessed using Doppler ultrasound at three time points: 1) pre-immersion; 2) 60 min post-immersion; 3) post-I/R (20 min of arm ischaemia followed by 20 min of reperfusion).,"[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Engelland', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Holden W', 'Initials': 'HW', 'LastName': 'Hemingway', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Olivia G', 'Initials': 'OG', 'LastName': 'Tomasco', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Albert H', 'Initials': 'AH', 'LastName': 'Olivencia-Yurvati', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Romero', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, TX, USA.'}]",Experimental physiology,['10.1113/EP088154']
659,31698920,Acceptability of electronic nicotine delivery systems (ENDS) among HIV positive smokers.,"Electronic nicotine delivery systems (ENDS) have the potential to help smokers living with HIV/AIDS (PLWHA) to reduce harms from tobacco use. However, little is known about ENDS use among PLWHA. This study's aim was to evaluate the acceptability of two types of ENDS among PLWHA not planning to quit smoking. The study utilized a cross-over design where participants used two ENDS in a random order as smoking substitutes during two use periods separated by 7 days. Exhaled carbon monoxide (CO) was analyzed and participants reported daily cigarette and ENDS use and completed ratings on ENDS acceptability. Participants ( n  = 17) were a mean age of 49.1 years (SD = 8.8), were 53% white, and 59% male. All participants had controlled HIV disease status. Participants smoked a mean of 16.9 (SD = 7.9) CPD at baseline. Overall, CPD significantly decreased during both ENDS use periods ( p  < .01) but there were no differences in reduction between the different devices. CO decreased from baseline to follow-up only during the button-activated ENDS use period ( p  = .03), but there were no differences between ENDS devices. There were no significant differences in ratings of acceptability between ENDS devices. These results suggest that ENDS could be a harm reduction tool for smokers with HIV.",2020,"CO decreased from baseline to follow-up only during the button-activated ENDS use period ( p  = .03), but there were no differences between ENDS devices.","['Participants ( n \u2009=\u200917) were a mean age of 49.1 years (SD\u2009=\u20098.8), were 53% white, and 59% male', 'smokers living with HIV/AIDS (PLWHA', 'smokers with HIV', 'All participants had controlled HIV disease status', 'HIV positive smokers']","['Electronic nicotine delivery systems (ENDS', 'ENDS', 'electronic nicotine delivery systems (ENDS', 'ENDS among PLWHA']","['ratings of acceptability', 'Overall, CPD', 'Exhaled carbon monoxide (CO', 'CO']","[{'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",,0.0432344,"CO decreased from baseline to follow-up only during the button-activated ENDS use period ( p  = .03), but there were no differences between ENDS devices.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Yingst', 'Affiliation': 'Department of Public Health Sciences, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foulds', 'Affiliation': 'Department of Public Health Sciences, Penn State University College of Medicine, Hershey, PA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zurlo', 'Affiliation': 'Department of Medicine, Penn State University College of Medicine, Hershey, PA USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Steinberg', 'Affiliation': 'Division of General Internal Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Department of Psychology, Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Du', 'Affiliation': 'Department of Public Health Sciences, Penn State University College of Medicine, Hershey, PA, USA.'}]",AIDS care,['10.1080/09540121.2019.1687835']
660,31109784,High-intensity interval exercise lowers postprandial glucose concentrations more in obese adults than lean adults.,"AIMS


To compare postprandial glucose responses to high-intensity interval exercise (HIE) between obese and lean individuals.
METHODS


Thirty healthy young adult males (15 obese, 15 lean) ate a standardised meal, then performed HIE (4 × 30-s Wingate cycling/4-min rest) or a no-exercise control trial (CON). Blood glucose was measured preprandially and up to 150 min postprandially.
RESULTS


Compared to CON, HIE reduced postprandial glucose concentrations at 120-150 min in obese (p < 0.001) and lean men (p < 0.05), with greater reductions in obese than lean subjects at 120 (-27.0% vs. -8.3%), 135 (-31.9% vs. -15.7%), and 150 min (-21.8% vs. -10.6%). The total glucose area under the curve (AUC) for the testing period was lower with HIE than CON among obese men (p < 0.05), but not lean men (p > 0.05). We found moderate correlations between body mass and postprandial glucose changes (r = 0.39-0.44, p < 0.05), and between glucose AUC and body mass and fat free mass (r = 0.39-0.48, p < 0.05).
CONCLUSIONS


Our findings suggest that HIE may act as a time-efficient lifestyle intervention strategy for improving obesity-related diabetes risk factors, and might play a role in primary diabetes prevention for the healthy but sedentary population.",2019,"Compared to CON, HIE reduced postprandial glucose concentrations at 120-150 min in obese (p < 0.001) and lean men (p < 0.05), with greater reductions in obese than lean subjects at 120 (-27.0% vs. -8.3%), 135 (-31.9% vs. -15.7%), and 150 min (-21.8% vs. -10.6%).","['Thirty healthy young adult males (15 obese, 15 lean) ate a', 'obese adults than lean adults', 'healthy but sedentary population', 'obese and lean individuals']","['standardised meal, then performed HIE (4\u2009×\u200930-s Wingate cycling/4-min rest) or a no-exercise control trial (CON', 'High-intensity interval exercise', 'high-intensity interval exercise (HIE']","['body mass and postprandial glucose changes', 'total glucose area under the curve (AUC', 'Blood glucose', 'postprandial glucose responses', 'glucose AUC and body mass and fat free mass', 'postprandial glucose concentrations']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}]",30.0,0.0367929,"Compared to CON, HIE reduced postprandial glucose concentrations at 120-150 min in obese (p < 0.001) and lean men (p < 0.05), with greater reductions in obese than lean subjects at 120 (-27.0% vs. -8.3%), 135 (-31.9% vs. -15.7%), and 150 min (-21.8% vs. -10.6%).","[{'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Kong', 'Affiliation': 'Faculty of Education, University of Macau, Macao, China. Electronic address: zwkong@umac.mo.'}, {'ForeName': 'Qingde', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'School of Physical Education and Sports, Macao Polytechnic Institute, Macao, China. Electronic address: qdshi@ipm.edu.mo.'}, {'ForeName': 'Shengyan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Faculty of Education, University of Macau, Macao, China; Institute of Physical Education, Huzhou University, Huzhou, Zhejiang Province, China. Electronic address: sysun@zjhu.edu.cn.'}, {'ForeName': 'Tomas K', 'Initials': 'TK', 'LastName': 'Tong', 'Affiliation': 'Dr. Stephen Hui Research Centre for Physical Recreation and Wellness, Department of Physical Education, Hong Kong Baptist University, Hong Kong, China. Electronic address: tongkk@hkbu.edu.hk.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'College of Physical Education, Hebei Normal University, Shijiazhuang, Hebei Province, China. Electronic address: hbnuzhanghaifeng@sina.com.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'School of Physical Education and Sports, Macao Polytechnic Institute, Macao, China. Electronic address: jnie@ipm.edu.mo.'}]",Primary care diabetes,['10.1016/j.pcd.2019.04.003']
661,31912285,EQ-5D-5L questionnaire as suitable assessment of quality of life after epiduroscopy : Multicenter randomized double-blind pilot study.,"BACKGROUND


Epiduroscopy is a well-established diagnostic and to certain level therapeutic tool in complex situations, where conventional methods such as magnetic resonance imaging (MRI) lack power or resolution to detect pathological changes. Such a situation is primarily failed back surgery syndrome (FBSS) but also radicular pain without surgery. The aim of this study was to determine the effectiveness of epiduroscopic treatment in patients with FBSS.
METHODS


A total of 79 patients with FBSS were randomized into 2 groups. The first group underwent epiduroscopy and received mechanical lysis of adhesions only, the second group received also medication into the epidural space (methylprednisolone and hyaluronidase). Patients were subsequently followed for 12 months, with evaluation also after 6 months post-epiduroscopy. Patients were checked in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression as defined in the 5‑dimensional EQ-5D-5L questionnaire and to asses suitability of this questionnaire in chronic pain states. Data were collected using EQ-5D-5L questionnaire and also quality of life (QoL) questionnaire.
RESULTS


In the terms of ability to walk (dimension mobility) and also ability to do housework, study or leisure activities (dimension usual activity) patients improved in both groups after 6 and 12 months after epiduroscopy. In pain dimension there was improvement mainly after 6 months which correlated also with self-care dimension and quality of life self-assessment. Results in anxiety/depression dimension were mixed.
CONCLUSION


Epiduroscopy appears to be a beneficial procedure for both patient groups, especially after 6 months, with some benefit remaining after 12 months. The EQ-5D-5L questionnaire seems to be a suitable and comprehensive way to assess patient health in chronic pain states.",2020,"Patients were checked in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression as defined in the 5‑dimensional EQ-5D-5L questionnaire and to asses suitability of this questionnaire in chronic pain states.","['patients with FBSS', '79\xa0patients with FBSS']","['EQ-5D-5L questionnaire', 'mechanical lysis of adhesions only, the second group received also medication into the epidural space (methylprednisolone and hyaluronidase', 'epiduroscopic', 'epiduroscopy']","['mobility, self-care, usual activities, pain/discomfort and anxiety/depression', 'quality of life', 'EQ-5D-5L questionnaire and also quality of life (QoL) questionnaire', 'self-care dimension and quality of life self-assessment', 'anxiety/depression dimension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963763', 'cui_str': 'Failed Back Surgery Syndrome'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0012826', 'cui_str': 'Lysis of adhesions (procedure)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0228134', 'cui_str': 'Epidural Space'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C0877073', 'cui_str': 'Epiduroscopy'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}]",,0.0531958,"Patients were checked in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression as defined in the 5‑dimensional EQ-5D-5L questionnaire and to asses suitability of this questionnaire in chronic pain states.","[{'ForeName': 'Róbert', 'Initials': 'R', 'LastName': 'Rapčan', 'Affiliation': 'Europainclinics, Kominárska 21/5, 831 04, Bratislava, Slovakia.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Kočan', 'Affiliation': 'Clinic of Anaesthesiology and Intensive Care Medicine, East Slovak Institute of Cardiovascular Disease, Ondavská\xa08, 040 11, Košice, Slovakia.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Witkovsky', 'Affiliation': 'Institute of Measurement Science, Slovak Academy of Sciences, Dúbravská cesta\xa09, 841 04, Bratislava, Slovakia.'}, {'ForeName': 'Juraj', 'Initials': 'J', 'LastName': 'Mláka', 'Affiliation': 'Poliklinika Terasa, Europainclinics, Toryská\xa01, 040 11, Košice, Slovakia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Griger', 'Affiliation': 'Europainclinics, Kominárska 21/5, 831 04, Bratislava, Slovakia.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Burianek', 'Affiliation': 'Europainclinics, Starochodovská\xa01750, 149 00, Prague 4, Czech Republic.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rapčanová', 'Affiliation': 'Europainclinics, Starochodovská\xa01750, 149 00, Prague 4, Czech Republic.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Hammond', 'Affiliation': 'Kent Institute of Medicine and Surgery, Newnham Court Way, ME14 5FT, Bearsted, Kent, UK.'}, {'ForeName': 'Ľubomír', 'Initials': 'Ľ', 'LastName': 'Poliak', 'Affiliation': 'Europainclinics, Kominárska 21/5, 831 04, Bratislava, Slovakia.'}, {'ForeName': 'Róbert', 'Initials': 'R', 'LastName': 'Tirpák', 'Affiliation': 'Department of Cardiac Surgery, East Slovak Institute of Cardiovascular Disease, Ondavská\xa08, 040 11, Košice, Slovakia.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Šimonová', 'Affiliation': '1st Clinic of Anaesthesiology and Intensive Care Medicine, Louis Pasteur University Hospital, SNP\xa01, 040 11, Košice, Slovakia.'}, {'ForeName': 'František', 'Initials': 'F', 'LastName': 'Sabol', 'Affiliation': 'Department of Cardiac Surgery, East Slovak Institute of Cardiovascular Disease, Ondavská\xa08, 040 11, Košice, Slovakia.'}, {'ForeName': 'Janka', 'Initials': 'J', 'LastName': 'Vašková', 'Affiliation': 'Department of Medical and Clinical Biochemistry, Faculty of Medicine, Pavol Jozef Šafárik University, Trieda SNP\xa01, 040 66, Košice, Slovakia. janka.vaskova@upjs.sk.'}]",Wiener klinische Wochenschrift,['10.1007/s00508-019-01590-z']
662,31107793,"Impact of Behavioral Feeding Intervention on Child Emotional and Behavioral Functioning, Parenting Stress, and Parent-Child Attachment.","OBJECTIVES


Behavioral intervention is the only treatment for pediatric feeding problems with well documented empirical support. However, parents may be hesitant to pursue behavioral intervention because of concerns about possible negative side effects on child behavioral health and the parent-child relationship. This study investigated associations between behavioral feeding treatment and parenting stress, internalizing and externalizing behavior problems in young children, and parent-child attachment quality.
METHODS


Participants included 16 mother-child dyads seeking treatment from a behavioral feeding clinic at a large Midwestern university medical center. Children were between the ages of 30 and 45 months (adjusted) at baseline. Caregivers completed the Child Behavior Checklist for ages 1.5 to 5 (CBCL/1.5-5), the Parenting Stress Index, 3rd Edition Short Form (PSI/SF), and mother-child dyads participated in the Strange Situation procedure at baseline and again after 6 months. The treatment group (n = 12) began outpatient behavioral feeding intervention following the baseline evaluation, whereas the control group (n = 12) remained on the clinic waitlist until after the 6-month follow-up.
RESULTS


The treatment group demonstrated decreases in internalizing and externalizing child behavior problems and parenting stress compared with the control group. No significant differences were demonstrated in parent-child attachment quality within or between groups.
CONCLUSIONS


Behavioral feeding intervention had positive effects on perceptions of child emotional and behavioral functioning and maternal parenting stress. Intervention also did not impact the quality of the mother-child attachment relationship. Further research with a larger sample size and additional observational measures of behavior is needed to support the replicability and generalizability of these results.",2019,The treatment group demonstrated decreases in internalizing and externalizing child behavior problems and parenting stress compared to the control group.,"['young children, and parent-child attachment quality', 'pediatric feeding problems with well-documented empirical support', 'Participants included 16 mother-child dyads seeking treatment from a behavioral feeding clinic at a large Midwestern university medical center']","['Behavioral intervention', 'outpatient behavioral feeding intervention', 'Behavioral feeding intervention', 'Behavioral Feeding Intervention']","['Child Emotional and Behavioral Functioning, Parenting Stress, and Parent-Child Attachment', 'quality of the mother-child attachment relationship', 'perceptions of child emotional and behavioral functioning and maternal parenting stress', 'parent-child attachment quality', 'internalizing and externalizing child behavior problems and parenting stress', 'parenting stress, internalizing and externalizing behavior problems', 'Child Behavior Checklist']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",,0.0203195,The treatment group demonstrated decreases in internalizing and externalizing child behavior problems and parenting stress compared to the control group.,"[{'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Knight', 'Affiliation': 'Division of Pediatric Psychology, Department of Pediatrics, Michigan Medicine, Ann Arbor.'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Albright', 'Affiliation': 'Methods Consultants, Ypsilanti, MI.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Huth-Bocks', 'Affiliation': 'Division of Developmental and Behavioral Pediatrics and Psychology, Department of Pediatrics, University Hospitals Cleveland Medical Center, Cleveland, OH.'}, {'ForeName': 'Natalie K', 'Initials': 'NK', 'LastName': 'Morris', 'Affiliation': 'Division of Pediatric Psychology, Department of Pediatrics, Michigan Medicine, Ann Arbor.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Mills', 'Affiliation': 'Division of Pediatric Psychology, Department of Pediatrics, Michigan Medicine, Ann Arbor.'}, {'ForeName': 'Kaylin', 'Initials': 'K', 'LastName': 'Klok', 'Affiliation': 'Division of Pediatric Psychology, Department of Pediatrics, Michigan Medicine, Ann Arbor.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Kallabat', 'Affiliation': 'Division of Pediatric Psychology, Department of Pediatrics, Michigan Medicine, Ann Arbor.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Drayton', 'Affiliation': 'Division of Pediatric Psychology, Department of Pediatrics, Michigan Medicine, Ann Arbor.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002382']
663,31748505,Effects of cannabidivarin (CBDV) on brain excitation and inhibition systems in adults with and without Autism Spectrum Disorder (ASD): a single dose trial during magnetic resonance spectroscopy.,"Autism spectrum disorder (ASD) is a high cost neurodevelopmental condition; and there are currently no effective pharmacological treatments for its core symptoms. This has led some families and researchers to trial alternative remedies - including the non-intoxicating Cannabis sativa-derived compound cannabidivarin (CBDV). However, how CBDV affects the human brain is unknown. Previous (pre)clinical evidence suggests that CBDV may modulate brain excitatory-inhibitory systems, which are implicated in ASD. Hence, our main aim was to test, for the first time, if CBDV shifts glutamate and/or GABA metabolites - markers of the brain's primary excitatory and inhibitory system - in both the 'typical' and autistic brain. Our subsidiary aim was to determine whether, within ASD, brain responsivity to CBDV challenge is related to baseline biological phenotype. We tested this using a repeated-measures, double-blind, randomized-order, cross-over design. We used magnetic resonance spectroscopy (MRS) to compare glutamate (Glx = glutamate + glutamine) and GABA + (GABA + macromolecules) levels following placebo (baseline) and 600 mg CBDV in 34 healthy men with (n = 17) and without (n = 17) ASD. Data acquisition from regions previously reliably linked to ASD (dorsomedial prefrontal cortex, DMPFC; left basal ganglia, BG) commenced 2 h (peak plasma levels) after placebo/CBDV administration. Where CBDV significantly shifted metabolite levels, we examined the relationship of this change with baseline metabolite levels. Test sessions were at least 13 days apart to ensure CBDV wash-out. CBDV significantly increased Glx in the BG of both groups. However, this impact was not uniform across individuals. In the ASD group, and not in the typically developing controls, the 'shift' in Glx correlated negatively with baseline Glx concentration. In contrast, CBDV had no significant impact on Glx in the DMPFC, or on GABA+ in either voxel in either group. Our findings suggest that, as measured by MRS, CBDV modulates the glutamate-GABA system in the BG but not in frontal regions. Moreover, there is individual variation in response depending on baseline biochemistry. Future studies should examine the effect of CBDV on behaviour and if the response to an acute dose of CBDV could predict a potential clinical treatment response in ASD.",2019,"In contrast, CBDV had no significant impact on Glx in the DMPFC, or on GABA+ in either voxel in either group.","['34 healthy men with (n\u2009=\u200917) and without (n\u2009=\u200917) ASD', 'adults with and without Autism Spectrum Disorder (ASD', 'Autism spectrum disorder (ASD']","['placebo (baseline) and 600\u2009mg CBDV', 'cannabidivarin (CBDV', 'magnetic resonance spectroscopy (MRS) to compare glutamate (Glx\u2009=\u2009glutamate\u2009+\u2009glutamine) and GABA\u2009+\u2009(GABA', 'magnetic resonance spectroscopy']",['brain excitation and inhibition systems'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3657549', 'cui_str': 'CBDV compound'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",34.0,0.290473,"In contrast, CBDV had no significant impact on Glx in the DMPFC, or on GABA+ in either voxel in either group.","[{'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'Pretzsch', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Voinescu', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lythgoe', 'Affiliation': ""Department of Neuroimaging Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Horder', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Maria Andreina', 'Initials': 'MA', 'LastName': 'Mendez', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wichers', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ajram', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Glynis', 'Initials': 'G', 'LastName': 'Ivin', 'Affiliation': 'South London and Maudsley NHS Foundation Trust Pharmacy, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heasman', 'Affiliation': 'South London and Maudsley NHS Foundation Trust Pharmacy, London, UK.'}, {'ForeName': 'Richard A E', 'Initials': 'RAE', 'LastName': 'Edden', 'Affiliation': 'Russel H Morgan Department of Radiology and Radiological Science, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': ""Department of Neuroimaging Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Declan G M', 'Initials': 'DGM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Gráinne M', 'Initials': 'GM', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. grainne.mcalonan@kcl.ac.uk.""}]",Translational psychiatry,['10.1038/s41398-019-0654-8']
664,31884429,Propofol versus Fentanyl for Sedation in Pediatric Bronchoscopy: A Randomized Controlled Trial.,"OBJECTIVE


To compare propofol and fentanyl to induce conscious sedation in children undergoing flexible bronchoscopy.
STUDY DESIGN


Randomized controlled trial.
SETTING


Pediatric Pulmonology division at a tertiary care center in Delhi, India.
PARTICIPANTS


Children aged 3-15 years who underwent flexible bronchoscopy.
INTERVENTION


Children received either intravenous propofol 1 mg/kg administered as a slow bolus over 1 minute followed by 2 mg/kg/hour infusion, or intravenous Fentanyl 2 µg/kg administered as a slow bolus over one minute.
OUTCOMES


Primary outcome was time to achieve conscious sedation (Ramsay score 3). Secondary outcomes were need for adjuvant midazolam, physician satisfaction, level of cough, recovery features, and side-effects in the groups.
RESULTS


53 children (propofol 27, fentanyl 26) were enrolled in the study. The mean (SD) time taken to achieve Ramsay score 03 was lower in propofol than fentanyl [15.7 (4.4) s vs 206 (55) s, P<0.001]. Propofol arm had significantly higher physician satisfaction, less requirement of adjuvant midazolam, less coughing and faster regain of full consciousness. There was no difference in drug side-effects between the groups.
CONCLUSIONS


Propofol has a shorter sedation induction time, less coughing during procedure, less recovery time, and better physician satisfaction compared to fentanyl for flexible bronchoscopy in children.",2019,"Propofol arm had significantly higher physician satisfaction, less requirement of adjuvant midazolam, less coughing and faster regain of full consciousness.","['children undergoing flexible bronchoscopy', 'Pediatric Pulmonology division at a tertiary care center in Delhi, India', '53 children (propofol 27, fentanyl 26) were enrolled in the study', 'Children aged 3-15 years who underwent flexible bronchoscopy', 'Pediatric Bronchoscopy']","['Fentanyl', 'Propofol', 'intravenous propofol', 'propofol and fentanyl']","['recovery time, and better physician satisfaction', 'mean (SD) time taken to achieve Ramsay score 03', 'need for adjuvant midazolam, physician satisfaction, level of cough, recovery features, and side-effects', 'physician satisfaction, less requirement of adjuvant midazolam, less coughing and faster regain of full consciousness', 'time to achieve conscious sedation (Ramsay score 3', 'drug side-effects']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C1635023', 'cui_str': 'Pediatric pulmonology'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}]",53.0,0.1479,"Propofol arm had significantly higher physician satisfaction, less requirement of adjuvant midazolam, less coughing and faster regain of full consciousness.","[{'ForeName': 'P K G', 'Initials': 'PKG', 'LastName': 'Gunathilaka', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kana Ram', 'Initials': 'KR', 'LastName': 'Jat', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jhuma', 'Initials': 'J', 'LastName': 'Sankar', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Kabra', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India. Correspondence to: Prof SK Kabra, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110 029, India, skkabra@hotmail.com.'}]",Indian pediatrics,[]
665,30981150,"Tibialis posterior muscle pain effects on hip, knee and ankle gait mechanics.","BACKGROUND


Tibialis posterior (TP) dysfunction is a common painful complication in patients with rheumatoid arthritis (RA), which can lead to the collapse of the medial longitudinal arch. Different theories have been developed to explain the causality of tibialis posterior dysfunction. In all these theories, pain is a central factor, and yet, it is uncertain to what extent pain causes the observed biomechanical alterations in the patients. The aim of this study was to investigate the effect of experimental tibialis posterior muscle pain on gait mechanics in healthy subjects.
METHODS


Twelve healthy subjects were recruited for this randomized crossover study. Experimental pain was induced by ultrasound-guided injection of 1 mL hypertonic saline into the upper part of the right tibialis posterior muscle with the use of isotonic saline as non-pain-inducing control. Subsequently, kinematic data during three self-paced over ground walking for each condition were collected. Ground reaction forces and external moments were measured from force plates installed in the floor. Painful areas were evaluated using body charts and pain intensity scoring via a verbal numerical rating scale.
FINDINGS


Decreased hip internal rotation was observed during the pain condition at the end of the stance phase. There were no changes in gait velocity and duration of stand phase between the pain and no pain conditions. Reduced external joint moment was found for external knee rotation and for external hip rotation.
INTERPRETATION


The study has demonstrated that induced pain in the TP muscle evokes kinematic alteration in the hip and the knee joints, but not in the ankle, which suggest an underlying early stage joint compensatory mechanism. These findings suggest the need to include those joints in current physical evaluations of tibialis posterior dysfunction.",2019,There were no changes in gait velocity and duration of stand phase between the pain and no pain conditions.,"['Twelve healthy subjects', 'patients with rheumatoid arthritis (RA', 'healthy subjects']","['experimental tibialis posterior muscle pain', 'isotonic saline']","['hip internal rotation', 'Tibialis posterior muscle pain effects on hip, knee and ankle gait mechanics', 'gait velocity and duration of stand phase between the pain and no pain conditions', 'body charts and pain intensity scoring via a verbal numerical rating scale', 'gait mechanics', 'Reduced external joint moment']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0224463', 'cui_str': 'Tibialis posterior muscle structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231459', 'cui_str': 'Medial rotation - action (qualifier value)'}, {'cui': 'C0224463', 'cui_str': 'Tibialis posterior muscle structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}]",12.0,0.0428635,There were no changes in gait velocity and duration of stand phase between the pain and no pain conditions.,"[{'ForeName': 'Morten Bilde', 'Initials': 'MB', 'LastName': 'Simonsen', 'Affiliation': 'Center for Sensory-Motoric Interaction (SMI®), Department of Health Science and Technology, Aalborg University, Fredrik Bajers Vej 7, DK-9220 Aalborg East, Denmark; Centre for Clinical Research, North Denmark Regional Hospital, Bispensgade 37, DK-9800 Hjoerring, Denmark.'}, {'ForeName': 'Aysun', 'Initials': 'A', 'LastName': 'Yurtsever', 'Affiliation': 'Centre for Clinical Research, North Denmark Regional Hospital, Bispensgade 37, DK-9800 Hjoerring, Denmark; Department of Rheumatology, Hjørring Hospital, Bispensgade 37, DK-9800 Hjørrring, Denmark.'}, {'ForeName': 'Ketill', 'Initials': 'K', 'LastName': 'Næsborg-Andersen', 'Affiliation': 'Centre for Clinical Research, North Denmark Regional Hospital, Bispensgade 37, DK-9800 Hjoerring, Denmark.'}, {'ForeName': 'Peter Derek Christian', 'Initials': 'PDC', 'LastName': 'Leutscher', 'Affiliation': 'Centre for Clinical Research, North Denmark Regional Hospital, Bispensgade 37, DK-9800 Hjoerring, Denmark; Department of Clinical Medicine, Aalborg University, Søndre Skovvej 15, DK-9000, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hørslev-Petersen', 'Affiliation': 'King Christian 10th Hospital for Rheumatic Diseases, University of Southern Denmark, Toldbodgade 3, DK-6300 Gråsten, Denmark.'}, {'ForeName': 'Michael Skipper', 'Initials': 'MS', 'LastName': 'Andersen', 'Affiliation': 'Department of Materials and Production, Aalborg University, Fibigerstraede 16, DK-9220 Aalborg East, Denmark.'}, {'ForeName': 'Rogerio Pessoto', 'Initials': 'RP', 'LastName': 'Hirata', 'Affiliation': 'Center for Sensory-Motoric Interaction (SMI®), Department of Health Science and Technology, Aalborg University, Fredrik Bajers Vej 7, DK-9220 Aalborg East, Denmark. Electronic address: rirata@hst.aau.dk.'}]",Human movement science,['10.1016/j.humov.2019.04.002']
666,29705935,Project SHINE: effects of a randomized family-based health promotion program on the physical activity of African American parents.,"This study examined the effects of a family-based health promotion intervention on the moderate-to-vigorous physical activity (MVPA), light physical activity, sedentary behavior, and fruit and vegetable intake of African American parents. Eighty-nine African American parents (41.5 ± 8.5 years; 92% females; 74% obese; 64% < $40 K income) and adolescents (12.5 ± 1.4 years; 61% girls; 48% obese) were randomized to a 6-week behavioral skills plus positive parenting and peer monitoring intervention grounded in social cognitive, self-determination, and family systems theories or a general health comparison program. Parents wore accelerometers for 7 days and completed three 24-h dietary recalls at baseline and post-intervention. Multilevel regression models (controlling for baseline variables) demonstrated a significantly greater increase in parent MVPA for those in the intervention versus comparison condition (b = 9.44, SE = 4.26, p < 0.05). There were no other significant effects. Family-based approaches that include African American parents and youth may increase parent MVPA and hold promise for preventing chronic diseases.",2018,"Multilevel regression models (controlling for baseline variables) demonstrated a significantly greater increase in parent MVPA for those in the intervention versus comparison condition (b = 9.44, SE = 4.26, p < 0.05).","['African American parents and youth', 'African American parents', 'Eighty-nine African American parents (41.5\u2009±\u20098.5\xa0years; 92% females; 74% obese; 64%\u2009<\u2009$40\xa0K income) and adolescents (12.5\u2009±\u20091.4\xa0years; 61% girls; 48% obese']","['behavioral skills plus positive parenting and peer monitoring intervention grounded in social cognitive, self-determination, and family systems theories or a general health comparison program', 'randomized family-based health promotion program', 'family-based health promotion intervention']","['moderate-to-vigorous physical activity (MVPA), light physical activity, sedentary behavior, and fruit and vegetable intake', 'parent MVPA']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0303276', 'cui_str': 'K-40 radioisotope'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0039154', 'cui_str': 'Systems Theory'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",89.0,0.0135485,"Multilevel regression models (controlling for baseline variables) demonstrated a significantly greater increase in parent MVPA for those in the intervention versus comparison condition (b = 9.44, SE = 4.26, p < 0.05).","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'St George', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Suite 1009, Miami, FL, 33136, USA. s.stgeorge@med.miami.edu.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'M Lee', 'Initials': 'ML', 'LastName': 'Van Horn', 'Affiliation': 'Department of Individual, Family, and Community Education, College of Education, University of New Mexico, Albuquerque, NM, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-018-9926-7']
667,31014938,"Effect of tele-rehabilitation on glucose control, exercise capacity, physical fitness, muscle strength and psychosocial status in patients with type 2 diabetes: A double blind randomized controlled trial.","AIM


To determine the effect of a tele-rehabilitation (TR) program on glucose control, exercise capacity, physical fitness, muscle strength and psychosocial status in patients with type 2 diabetes mellitus (DM).
METHOD


Fifty type 2 DM participants were enrolled in the study and divided randomly into two groups; TR (n = 25, mean age: 52.82 ± 11.86) or control (n = 25, mean age: 53.04 ± 10.45) group. Participants in the TR group performed breathing and callisthenic exercises, three times a week, for 6 weeks, at home by internet based video conferences. Outcome measures including, HbA1c level, 6 min walk testing, physical fitness and muscle strength dynamometer measurement, Beck Depression Inventory were performed before and after the 6 weeks.
RESULTS


HbA1c (p = 0.00), 6 min walking distance (p = 0.00), physical fitness subparameters; sit-up (p = 0.00), sit-and-reach (p = 0.04), back scratch (p = 0.00), lateral flexion right (p = 0.04), left (p = 0.00) and time up go tests (p = 0.00), muscles strength (p = 0.00); deltoideus-anterior, middle, quadriceps femoris and gluteus maximus, and depression levels (p = 0.00) changed significantly (p = 0.00) in TR groups. There were no significant improvements in control group (p > 0.05).
CONCLUSION


Our findings suggest that TR interventions found to be safe and effective, and may be an alternative treatment model for type 2 DM management. In addition to these health benefits, patients and rehabilitation team may save time, labor and treatment costs by using TR.",2019,"left (p = 0.00) and time up go tests (p = 0.00), muscles strength (p = 0.00); deltoideus-anterior, middle, quadriceps femoris and gluteus maximus, and depression levels (p = 0.00) changed significantly (p = 0.00) in TR groups.","['Fifty type 2 DM participants', 'mean age: 52.82\u2009±\u200911.86) or control (n\u2009=\u200925, mean age: 53.04\u2009±\u200910.45) group', 'patients with type 2 diabetes mellitus (DM', 'patients with type 2 diabetes']","['TR interventions', 'tele-rehabilitation', 'tele-rehabilitation (TR) program']","['deltoideus-anterior, middle, quadriceps femoris and gluteus maximus, and depression levels', 'lateral flexion right', '6\u2009min walking distance', 'muscles strength', 'HbA1c level, 6\u2009min walk testing, physical fitness and muscle strength dynamometer measurement, Beck Depression Inventory', 'glucose control, exercise capacity, physical fitness, muscle strength and psychosocial status', 'back scratch', 'save time, labor and treatment costs', 'sit-and-reach']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion, function (observable entity)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1721018', 'cui_str': 'Muscle Strength Dynamometer'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0337459', 'cui_str': 'Psychosocial status (social concept)'}, {'cui': 'C1384489', 'cui_str': 'Scratch marks (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",50.0,0.013801,"left (p = 0.00) and time up go tests (p = 0.00), muscles strength (p = 0.00); deltoideus-anterior, middle, quadriceps femoris and gluteus maximus, and depression levels (p = 0.00) changed significantly (p = 0.00) in TR groups.","[{'ForeName': 'Neslihan', 'Initials': 'N', 'LastName': 'Duruturk', 'Affiliation': 'Baskent University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Ankara, Turkey. Electronic address: nalkan@baskent.edu.tr.'}, {'ForeName': 'Manolya Acar', 'Initials': 'MA', 'LastName': 'Özköslü', 'Affiliation': 'Baskent University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Ankara, Turkey.'}]",Primary care diabetes,['10.1016/j.pcd.2019.03.007']
668,31728681,"Prebiotic supplementation modulates advanced glycation end-products (AGEs), soluble receptor for AGEs (sRAGE), and cardiometabolic risk factors through improving metabolic endotoxemia: a randomized-controlled clinical trial.","PURPOSE


The oxidative stress plays a key role in the initiation, propagation, and development of the complications of type 2 diabetes mellitus (T2DM). This trial aimed to evaluate the effects of resistant dextrin as a prebiotic on the cardiometabolic risk factors and the status of oxidative stress in patients with T2DM.
METHODS


Sixty-five female subjects with T2DM were assigned to either the intervention (n = 33) or control (n = 32) groups receiving 10 g/day of resistant dextrin or placebo, respectively, for 8 weeks. Fasting blood samples were collected at baseline and post-intervention to determine the serum levels of glycemic indices, lipid profile, atherogenic indices, and soluble receptor for AGEs (sRAGE), carboxymethyl lysine (CML), pentosidine, malondialdehyde (MDA), 8-iso-prostaglandin F2α (8-iso-PGF2α), total antioxidant capacity (TAC), antioxidant enzymes activity, and uric acid. Data were analyzed using SPSS software 17. Paired, unpaired Student's t tests, and analysis of covariance were used to compare the quantitative variables.
RESULTS


Resistant dextrin caused a significant decrease in FPG (- 17.43 mg/dl, 9.80%), TG (- 40.25 mg/dl, 23.01%), TC/HDL (- 0.80, 21.87%), LDL-c/HDL-c (- 0.80, 17.85%), Atherogenic index (- 0.40, 15.80%), LPS (- 6.5 EU/ml, 23.40%) and hs-CRP (- 8.02 ng/ml, 54.00%), MDA (- 1.21 nmol/mL, 25.58%), CML (- 93.40 ng/ml, 26.30%), 8-iso-PGF2α (- 4.65 pg/ml, 15.00%), and a significant increase in TAC (0.33 mmol/L, 36.25%) and s-RAGE (2.10 ng/ml, 28.90%) in the intervention group compared with the control group. No significant changes were observed in glycosylated hemoglobin, total cholesterol, LDL-c, HDL-c, superoxide dismutase, glutathione peroxidase and catalase, pentosidine, and uric acid in the intervention group compared with the control group.
CONCLUSIONS


Supplementation with resistant dextrin may improve the advanced glycation end-products, sRAGE, and cardiometabolic risk factors in women with type 2 diabetes mellitus.",2020,"No significant changes were observed in glycosylated hemoglobin, total cholesterol, LDL-c, HDL-c, superoxide dismutase, glutathione peroxidase and catalase, pentosidine, and uric acid in the intervention group compared with the control group.
","['women with type 2 diabetes mellitus', 'Sixty-five female subjects with T2DM', 'patients with T2DM']","['control (n\u2009=\u200932) groups receiving 10\xa0g/day of resistant dextrin or placebo', 'Prebiotic supplementation', 'resistant dextrin']","['glycosylated hemoglobin, total cholesterol, LDL-c, HDL-c, superoxide dismutase, glutathione peroxidase and catalase, pentosidine, and uric acid', 'TAC', 'Fasting blood samples', 'FPG', 'Atherogenic index', '8-iso-PGF2α', 'TC/HDL', 'serum levels of glycemic indices, lipid profile, atherogenic indices, and soluble receptor for AGEs (sRAGE), carboxymethyl lysine (CML), pentosidine, malondialdehyde (MDA), 8-iso-prostaglandin F2α (8-iso-PGF2α), total antioxidant capacity (TAC), antioxidant enzymes activity, and uric acid', 'MDA', 'advanced glycation end-products, sRAGE, and cardiometabolic risk factors']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0054527', 'cui_str': 'caloreen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0070317', 'cui_str': 'pentosidine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4508788', 'cui_str': 'carboxymethyl-lysine'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation Endproducts'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",65.0,0.124877,"No significant changes were observed in glycosylated hemoglobin, total cholesterol, LDL-c, HDL-c, superoxide dismutase, glutathione peroxidase and catalase, pentosidine, and uric acid in the intervention group compared with the control group.
","[{'ForeName': 'Mahdieh Abbasalizad', 'Initials': 'MA', 'LastName': 'Farhangi', 'Affiliation': 'Drug Applied Research Center, Nutrition Research Center, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Dehghan', 'Affiliation': 'Nutrition Research Center, Immunology Research Center, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, 5166614711, Iran. dehghan.nut@gmail.com.'}, {'ForeName': 'Nazli', 'Initials': 'N', 'LastName': 'Namazi', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",European journal of nutrition,['10.1007/s00394-019-02140-z']
669,31029515,Safety and immunogenicity of non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine.,"Non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) are frequent pathogens in acute exacerbations of COPD. We assessed the safety, reactogenicity and immunogenicity of different investigational vaccine formulations containing surface proteins of NTHi (PD and PE-PilA) and Mcat (UspA2) in adults with smoking history ≥10 pack-years, to immunologically represent the COPD population. Participants received two doses 60 days apart in a randomised, observer-blind, placebo-controlled study (NCT02547974). In step 1, 30 healthy adults aged 18-40 years were randomised (1:1) to receive a non-adjuvanted formulation (10-10-PLAIN) or placebo. In step 2, 90 smokers/ex-smokers aged 50-70 years randomly (1:1:1) received an AS01-adjuvanted formulation containing either 10 µg of each antigen (10-10-AS01) or 10 µg of each NTHi antigen and 3.3 µg of Mcat antigen (10-3-AS01), or placebo. Incidences of solicited local adverse events (AEs) tended to be highest in the AS01-adjuvanted vaccine groups. Most solicited AEs had mild/moderate intensity. No vaccine-related serious AEs were reported. The 10-3-AS01 formulation induced the best humoral immune response against the NTHi antigens. Responses against the Mcat antigen were similar across groups, with waning immunogenicity after 30 days post-dose 2. The investigational NTHi-Mcat vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in older adults with a smoking history.",2019,The investigational NTHi-Mcat vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in older adults with a smoking history.,"['older adults with a smoking history', '30 healthy adults aged 18-40\u202fyears', '90 smokers/ex-smokers aged 50-70\u202fyears randomly (1:1:1) received an', 'adults with smoking history ≥10 pack-years']","['placebo', 'AS01-adjuvanted formulation containing either 10\u202fµg of each antigen (10-10-AS01) or 10\u202fµg of each NTHi antigen and 3.3\u202fµg of Mcat antigen (10-3-AS01), or placebo', 'non-adjuvanted formulation (10-10-PLAIN) or placebo', 'non-typeable Haemophilus influenzae-Moraxella catarrhalis vaccine', 'NTHi (PD and PE-PilA) and Mcat (UspA2']","['Safety and immunogenicity', 'acceptable safety and reactogenicity profile and good immunogenicity', 'humoral immune response', 'safety, reactogenicity and immunogenicity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4555205', 'cui_str': 'Ex-Smokers'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0018483', 'cui_str': 'Haemophilus influenzae'}, {'cui': 'C0026536', 'cui_str': 'Moraxella'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0323968', 'cui_str': 'Pila'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1155229'}]",30.0,0.293994,The investigational NTHi-Mcat vaccine had an acceptable safety and reactogenicity profile and good immunogenicity in older adults with a smoking history.,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'Centre for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Leroux-Roels', 'Affiliation': 'Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Vandermeulen', 'Affiliation': 'Leuven University Vaccinology Centre, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Ryck', 'Affiliation': 'GSK Vaccines, Siena, Italy.'}, {'ForeName': 'Annaelisa', 'Initials': 'A', 'LastName': 'Tasciotti', 'Affiliation': 'GSK Vaccines, Siena, Italy.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Dozot', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Moraschini', 'Affiliation': 'GSK Vaccines, Siena, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Testa', 'Affiliation': 'GSK Vaccines, Siena, Italy. Electronic address: marco.x.testa@gsk.com.'}, {'ForeName': 'Ashwani Kumar', 'Initials': 'AK', 'LastName': 'Arora', 'Affiliation': 'GSK Vaccines, Siena, Italy.'}]",Vaccine,['10.1016/j.vaccine.2019.04.041']
670,31029516,Comparison of the immunogenicity of Dukoral® oral cholera vaccine between renal transplant recipients on either a calcineurin inhibitor or mycophenolate - A controlled trial.,"BACKGROUND


The evidence for recommendations regarding vaccination in solid organ transplant recipients is sparse. There is little data comparing vaccine responses between groups on different immunosuppressive drugs. This study was conducted to evaluate the antibody response to Dukoral® oral cholera vaccine in renal transplant recipients (RTR).
METHODS


In a single-center non-randomized controlled clinical trial, healthy volunteers (n = 21) and renal transplant recipients (n = 30) were vaccinated with the oral whole cell/recombinant B subunit cholera vaccine Dukoral® (Valneva Inc., Vienna, Austria). The RTR were stratified according to their maintenance immunosuppressive therapy: either prednisone and a calcineurin inhibitor (cyclosporine A or tacrolimus; P/CNI group; n = 15) or prednisone and mycophenolate (P/MMF group; n = 15). All volunteers ingested Dukoral® at baseline and at day 14. Serum samples were drawn at day 0 and day 21. The primary outcome was seroconversion, defined as either a 3-fold IgA serum titer increase in anti-cholera toxin B antibodies and/or a 4-fold rise in the serum vibriocidal titer.
RESULTS


Follow-up was complete. Seroconversion after vaccination was 57% (standard error, SE 9%) in RTR and 81% (SE 9%) in healthy controls (Relative Risk, RR 0.70; 95% CI 0.48-1.02). When stratified according to maintenance immunosuppression, the seroconversion rate was 67% (SE 12%) in the P/CNI group (RR compared with controls 0.82; 95% CI 0.55-1.25) and 47% (SE 13%) in the P/MMF group (RR compared with controls 0.58; 95% CI 0.32-1.03).
CONCLUSION


Adverse events were mild to moderate and transient. The response to Dukoral was weaker and the seroconversion rate was lower in renal transplant recipients than in healthy controls. In particular, those using mycophenolate had a poor response. Nevertheless, more than half of the transplant recipients seroconverted. Therefore oral vaccines should not be discarded as a potential tool for protection of solid organ transplant recipients. This trial is registered in clinicaltrials.gov under NCT01109914.",2019,The response to Dukoral was weaker and the seroconversion rate was lower in renal transplant recipients than in healthy controls.,"['renal transplant recipients on either a', 'renal transplant recipients (RTR', 'healthy volunteers (n\u202f=\u202f21) and renal transplant recipients (n\u202f=\u202f30']","['Dukoral® oral cholera vaccine', 'mycophenolate', 'calcineurin inhibitor or mycophenolate', 'oral whole cell/recombinant B subunit cholera vaccine Dukoral® (Valneva Inc., Vienna, Austria', 'prednisone and a calcineurin inhibitor (cyclosporine A or tacrolimus; P/CNI group; n\u202f=\u202f15) or prednisone and mycophenolate']","['antibody response', 'Adverse events', 'seroconversion rate', 'seroconversion, defined as either a 3-fold IgA serum titer increase in anti-cholera toxin B antibodies', 'serum vibriocidal titer']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3713288', 'cui_str': 'Dukoral'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0008356', 'cui_str': 'Choleragen'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",30.0,0.121818,The response to Dukoral was weaker and the seroconversion rate was lower in renal transplant recipients than in healthy controls.,"[{'ForeName': 'Emile F F', 'Initials': 'EFF', 'LastName': 'Jonker', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marjolein A C', 'Initials': 'MAC', 'LastName': 'Uijlings', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Leonardus G', 'Initials': 'LG', 'LastName': 'Visser', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Soonawala', 'Affiliation': 'Department of Nephrology, Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine, Haga Teaching Hospital, The Hague, the Netherlands. Electronic address: d.soonawala@lumc.nl.'}]",Vaccine,['10.1016/j.vaccine.2019.04.010']
671,31729622,"Effects of a multispecies synbiotic on glucose metabolism, lipid marker, gut microbiome composition, gut permeability, and quality of life in diabesity: a randomized, double-blind, placebo-controlled pilot study.","PURPOSE


Diabesity, the combination of obesity and type 2 diabetes, is an ever-growing global health burden. Diabesity-associated dysbiosis of the intestinal microbiome has gained attention as a potential driver of disease and, therefore, a possible therapeutic target by means of pro- or prebiotic supplementation. This study tested the effects of a multispecies synbiotic (i.e. a combination of probiotics and prebiotics) on glucose metabolism, gut microbiota, gut permeability, neutrophil function and quality of life in treatment-experienced diabesity patients.
METHODS


A randomized, double-blind, placebo-controlled pilot study with 26 diabesity patients was conducted in which patients received a daily dose of a multispecies probiotic and a prebiotic (or a placebo) for 6 months.
RESULTS


There were no changes in glucose metabolism or mixed meal tolerance test responses throughout the study. The analysis of secondary outcomes revealed beneficial effects on hip circumference [- 1 (95% CI - 4; 3) vs +3 (- 1; 8) cm, synbiotics vs. placebo, respectively, p = 0.04], serum zonulin [- 0.04 (- 0.2; 0.1) vs +0.3 (- 0.05; 0.6) ng/ml, p = 0.004)] and the physical role item of the SF36 quality of life assessment [+ 5.4 (- 1.7; 12.5) vs - 5.0 (- 10.1; 0.2) points, p = 0.02] after 3 months of intervention, and lipoprotein (a) [- 2.1 (- 5.7; 1.6) vs +3.4 (- 0.9; 7.9) mg/dl, p = 0.02] after 6 months. There were no significant differences in alpha or beta diversity of the microbiome between groups or time points.
CONCLUSIONS


Glucose metabolism as the primary outcome was unchanged during the intervention with a multispecies synbiotic in patients with diabesity. Nevertheless, synbiotics improved some symptoms and biomarkers of type 2 diabetes and aspects of quality of life suggesting a potential role as adjuvant tool in the management of diabesity.",2020,There were no changes in glucose metabolism or mixed meal tolerance test responses throughout the study.,"['treatment-experienced diabesity patients', 'patients with diabesity', '26 diabesity patients']","['placebo', 'multispecies synbiotic', 'multispecies probiotic and a prebiotic (or a placebo', 'multispecies synbiotic (i.e. a combination of probiotics and prebiotics']","['beneficial effects on hip circumference', 'physical role item of the SF36 quality of life assessment', 'glucose metabolism, gut microbiota, gut permeability, neutrophil function and quality of life', 'serum zonulin', 'glucose metabolism or mixed meal tolerance test responses', 'alpha or beta diversity', 'glucose metabolism, lipid marker, gut microbiome composition, gut permeability, and quality of life in diabesity']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0914216', 'cui_str': 'prehaptoglobin 2'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.44428,There were no changes in glucose metabolism or mixed meal tolerance test responses throughout the study.,"[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Horvath', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria. angela.horvath@medunigraz.at.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'Division of Transplantation Surgery, Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Feldbacher', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Tripolt', 'Affiliation': 'Division of Endocrinology and Diabetology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rainer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Blesl', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Trieb', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Marsche', 'Affiliation': 'Division of Pharmacology, Otto Loewi Research Center, Medical University of Graz, Universitätsplatz 4, 8010, Graz, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sourij', 'Affiliation': 'Center for Biomarker Research in Medicine (CBmed), Stiftingtalstrasse 5, 8010, Graz, Austria.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Stadlbauer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.'}]",European journal of nutrition,['10.1007/s00394-019-02135-w']
672,31074576,Efficacy of Computer-Based Telephone Counseling on Long-Term Adherence to Strength Training in Elderly Patients With Knee Osteoarthritis: A Randomized Trial.,"OBJECTIVE


To determine whether the Boston Overcoming Osteoarthritis through Strength Training Telephone-Linked Communication (BOOST-TLC) program, a novel telephone-based, motivational, strength-training exercise-adherence counseling intervention, improved adherence to a strength-training exercise program over 2 years.
METHODS


Participants were recruited for this 2-year, single-blind, parallel-arm randomized controlled trial from knee osteoarthritis patient registries, community newspapers, and online websites in Massachusetts. Eligibility criteria included age 50 years or older, painful knee osteoarthritis, and ability to use a telephone. Exclusion criteria included medical conditions precluding exercise, inflammatory arthritis, current regular strength training, planned knee replacement surgery, dementia, inability to follow exercise instructions, and inability to use the TLC system. After participating in a group exercise class, participants were randomized to receiving motivational telephone calls through the BOOST-TLC program for 24 months or the control. Both control and intervention participants received a monthly automated phone message reminder to continue the program. Exercise adherence was ascertained by a single self-report item scored 0-10, where 10 represented complete adherence. Outcomes were evaluated at 6, 12, 18, and 24 months.
RESULTS


A total of 104 subjects were randomized, and 89 subjects (44 control, 45 TLC) completed the 24-month follow-up. There was no significant difference in adherence at 24 months between groups (mean for control group 4.01 [95% confidence interval (95% CI) 3.03, 4.99], mean for TLC subjects 3.63 [95% CI 2.70, 4.56]; P = 0.57).
CONCLUSION


In those with knee osteoarthritis who had participated in an exercise program, frequent motivational telephone reminders did not increase adherence to strength-training exercise.",2020,"There was no significant difference in adherence at 24-months between groups (4.01 (3.03, 4.99) in controls, 3.63 (2.70, 4.56) in TLC subjects, p=0.57).
","['104 subjects were randomized and 89 subjects (44 control, 45 TLC) completed the 24-month follow-up', 'Eligibility criteria included age 50 or older, painful knee osteoarthritis and ability to use a telephone', 'Participants were recruited from knee osteoarthritis patient registries, community newspapers, and online websites', 'Elders with Knee Osteoarthritis']","['telephone-based motivational strength training exercise adherence counseling intervention', 'Strength Training', 'Computer-based Telephone Counseling', 'exercise program, frequent motivational telephone reminders', 'motivational telephone calls through the BOOST-TLC program', 'Boston Overcoming Osteoarthritis through Strength Training Telephone-Linked Communication (BOOST-TLC) program']","['adherence to strength training exercise', 'adherence', 'Exercise adherence']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",104.0,0.0351411,"There was no significant difference in adherence at 24-months between groups (4.01 (3.03, 4.99) in controls, 3.63 (2.70, 4.56) in TLC subjects, p=0.57).
","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'LaValley', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Ledingham', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'Julie J', 'Initials': 'JJ', 'LastName': 'Keysor', 'Affiliation': 'MGH Institute of Health Professions, Boston, Massachusetts.'}]",Arthritis care & research,['10.1002/acr.23921']
673,31033396,Taking Repeated Exposure into Account: An Experimental Study of Direct-To-Consumer Prescription Drug Television Ad Effects.,"Introduction : Little is known about how repeated exposure to direct-to-consumer prescription drug promotion can impact consumers' retention and perceptions of drug information. The study described here tested the effects of varied ad exposure frequency on these outcomes.  Methods : In an in-person experiment, participants with seasonal allergies ( n  = 616) were randomized to view a mock prescription drug television ad either once, twice, or four times within 1 h of television programming, embedded with six commercial breaks. Respondents then answered a 20-min survey administered via computer.  Results : Those who viewed the ad more frequently were better able to recall both risk ( X 2  = 20.93,  p  < .001) and benefit information ( X 2  = 9.34,  p  = .009) and to recognize risk ( F (2,597) = 11.89,  p  = .001) and benefit information ( F (2,597) = 3.17,  p  = .043) than those who viewed the ad one time. Ad exposure frequency was not associated with perceptions about the magnitude or likelihood of risks or benefits. In general, risk information seemed to require more repetitions than benefit information to be accurately remembered. The recall was mediated by elaborate processing.  Discussion : Effects on memory were small; retention of both risks and benefits remained low overall even after four exposures.",2019,"Those who viewed the ad more frequently were better able to recall both risk (X 2  = 20.93, p < .001) and benefit information (X 2  = 9.34, p = .009) and to recognize risk (F(2,597) =",['participants with seasonal allergies (n = 616'],[],[],"[{'cui': 'C0018621', 'cui_str': 'Rhinitis, Allergic, Seasonal'}]",[],[],616.0,0.0425935,"Those who viewed the ad more frequently were better able to recall both risk (X 2  = 20.93, p < .001) and benefit information (X 2  = 9.34, p = .009) and to recognize risk (F(2,597) =","[{'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Betts', 'Affiliation': 'a U.S. Food and Drug Administration, Office of Prescription Drug Promotion , Silver Spring , MD , USA.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': 'a U.S. Food and Drug Administration, Office of Prescription Drug Promotion , Silver Spring , MD , USA.'}, {'ForeName': 'Bridget J', 'Initials': 'BJ', 'LastName': 'Kelly', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Parvanta', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Southwell', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mack', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Tzeng', 'Affiliation': 'b Center for Communication Science, RTI International , Research Triangle Park , NC , USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cameron', 'Affiliation': 'c Psychological Sciences, School of Social Sciences, Humanities, and Arts, University of California, Merced , Merced , CA , USA.'}]",Journal of health communication,['10.1080/10810730.2019.1609139']
674,31058771,A Randomized Trial of Maternal Docosahexaenoic Acid Supplementation to Reduce Inflammation in Extremely Preterm Infants.,"Maternal supplementation with 1000 mg/day docosahexaenoic acid (DHA) provides third trimester DHA accretion levels in breast milk for the preterm infant. We hypothesized that DHA supplementation to mothers providing breastmilk for extremely preterm infants would result in decreased inflammatory markers, in the infant. Mother/infant dyads (n = 27) were enrolled at birth and mothers were assigned to receive 200 or 1000 mg/day of DHA. Milk and plasma samples were analyzed for fatty acids and inflammatory markers. Decreases in inflammation were observed in both maternal and infant plasma and correlated with red blood cell (RBC) DHA levels. The fact that maternal DHA supplementation decreases infant markers of inflammation implies that DHA, delivered through breastmilk, has the potential to decrease inflammation in the infant.",2019,"We hypothesized that DHA supplementation to mothers providing breastmilk for extremely preterm infants would decrease inflammatory markers, in the infant.","['Extremely Preterm Infants', 'Mother/infant dyads (n\u200a=\u200a27) were enrolled at birth and mothers']","['DHA supplementation', 'Maternal Docosahexaenoic Acid Supplementation', 'Maternal supplementation with 1000\u200amg/day docosahexaenoic acid (DHA']","['red blood cell (RBC) DHA levels', 'inflammation']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0556102', 'cui_str': 'DHA - Docosahexaenoic acid supplementation'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.273033,"We hypothesized that DHA supplementation to mothers providing breastmilk for extremely preterm infants would decrease inflammatory markers, in the infant.","[{'ForeName': 'Christina J', 'Initials': 'CJ', 'LastName': 'Valentine', 'Affiliation': 'The University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Dingess', 'Affiliation': 'Biomolecular Mass Spectrometry and Proteomics, Bijvoet Center for Biomolecular Research and Utrecht Institute for Pharmaceutical Sciences, University of Utrecht, The Netherlands.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Kleiman', 'Affiliation': ""Cincinnati Children's Hospital, Center for Infectious Diseases, Cincinnati.""}, {'ForeName': 'Ardythe L', 'Initials': 'AL', 'LastName': 'Morrow', 'Affiliation': 'The University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Lynette K', 'Initials': 'LK', 'LastName': 'Rogers', 'Affiliation': ""The Research Institute at Nationwide Children's Hospital, Columbus, OH.""}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002375']
675,31058779,Group Treatment of Fecal Incontinence: A Description of an Interdisciplinary Intervention.,"INTRODUCTION


Approximately 5% of children in the United States have chronic fecal incontinence. Unfortunately, standard medical management of fecal incontinence fails in 20% to 60% of cases. A combined medical-behavioral model is often recommended in these cases. The purpose of this pilot study was to describe an interdisciplinary group-based treatment for fecal incontinence in school-aged children, and to present a description of changes in treatment adherence rates that affect clinical effectiveness.
METHOD


Poop group employed a developmentally appropriate model of care in which caregivers and children participated in separate but simultaneously held therapy groups. This interdisciplinary 6-week protocol is designed to increase appropriate stooling, decrease soiling events, and increase medication adherence pre- to post-treatment. Group sessions focus on the GI system, medication, toilet sitting posture, hydration, fiber, and behavior contracts. In addition, participant families consult with an Advanced Nurse Practitioner privately at each session discussing symptoms and making medication modifications as needed.
RESULTS


Nineteen families completed the 6-week protocol. Appropriate stool frequency was improved (P ≤ 0.01), and soiling was reduced (P ≤ 0.00). Medication adherence was also improved (P ≤ 0.04). Treatment results were maintained at 1-month follow-up.
DISCUSSION


A developmentally targeted intervention and interdisciplinary focus of treatment likely account for treatment successes.
CONCLUSION


Poop group may be an effective interdisciplinary treatment option for families of children who fail traditional outpatient treatment.",2019,"Appropriate stool frequency was improved (p ≤ 0.01), and soiling was reduced (p ≤ .00).","['Nineteen families completed the 6-week protocol', 'families of children who fail traditional outpatient treatment', 'school-aged children']","['interdisciplinary group-based treatment', 'GI system, (2) medication, (3) toilet sitting posture, (4) hydration, (5) fiber, and (6) behavior contracts']","['Medication adherence', 'soiling', 'chronic fecal incontinence', 'Fecal Incontinence', 'Appropriate stool frequency', 'soiling events', 'fecal incontinence']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1140607', 'cui_str': 'Toilets'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0349450', 'cui_str': 'Soiling (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",19.0,0.019165,"Appropriate stool frequency was improved (p ≤ 0.01), and soiling was reduced (p ≤ .00).","[{'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Gonring', 'Affiliation': 'Marquette University.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Dolan', 'Affiliation': 'Marquette University.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Kapke', 'Affiliation': 'Marquette University.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Begotka', 'Affiliation': ""Children's Hospital of Wisconsin.""}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Sood', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Silverman', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002372']
676,31075459,Design of the PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) Trial.,"For patients with abdominal aortic aneurysm (AAA), randomized trials have found endovascular AAA repair (EVAR) is associated with lower perioperative morbidity and mortality than open surgical repair (OSR). However, OSR has fewer long-term aneurysm-related complications, such as endoleak or late rupture. Patients treated with EVAR and OSR have similar survival rates within two years after surgery, and OSR does not require intensive surveillance. Few have examined if patient preferences are aligned with the type of treatment they receive for their AAA. Although many assume that patients may universally prefer the less-invasive nature of EVAR, our preliminary work suggests that patients who value the lower risk of late complications may prefer OSR. In this study, called The PReferences for Open Versus Endovascular Repair of Abdominal Aortic Aneurysm (PROVE-AAA) trial, we describe a cluster-randomized trial to test if a decision aid can better align patients' preferences and their treatment type for AAA. Patients enrolled in the study are candidates for either endovascular or open repair and are followed up at VA hospitals by vascular surgery teams who regularly perform both types of repair. In Aim 1, we will determine patients' preferences for endovascular or open repair and identify domains associated with each repair type. In Aim 2, we will assess alignment between patients' preferences and the repair type elected and then compare the impact of a decision aid on this alignment between the intervention and control groups. This study will help us to accomplish two goals. First, we will better understand the factors that affect patient preference when choosing between EVAR and OSR. Second, we will better understand if a decision aid can help patients be more likely to receive the treatment strategy they prefer for their AAA. Study enrollment began on June 1, 2017. Between June 1, 2017 and November 1, 2018, we have enrolled 178 of a total goal of 240 veterans from 20 VA medical centers and their vascular surgery teams across the country. We anticipate completing enrollment in PROVE-AAA in June 2019, and study analyses will be performed thereafter.",2020,"Patients treated with EVAR and OSR have similar survival rates within two years following surgery, and OSR does not require intensive surveillance.","['Patients enrolled in the study are candidates for either endovascular or open repair, and are followed at VA hospitals by vascular surgery teams who regularly perform both types of repair', 'Between June 1, 2017 and November 1, 2018, we have enrolled 178 of a total goal of 240 Veterans from 20 VA Medical Centers and their vascular surgery teams across the country', 'patients with abdominal aortic aneurysm', ""patients' preferences for endovascular or open repair and identify domains associated with each repair type""]","['endovascular AAA repair (EVAR', 'EVAR and OSR']",['survival rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3714645', 'cui_str': 'Vascular surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0449521', 'cui_str': 'Type of repair (attribute)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0162871', 'cui_str': 'Aortic Aneurysm, Abdominal'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.15694,"Patients treated with EVAR and OSR have similar survival rates within two years following surgery, and OSR does not require intensive surveillance.","[{'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Columbo', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Spangler', 'Affiliation': 'Department of Vascular Surgery, Birmingham VA Medical Center, Birmingham, AL.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Newhall', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Brooke', 'Affiliation': 'Department of Vascular Surgery, George E. Wahlen Department of Veterans Affairs Medical Center, Salt Lake City, UT.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Dosluoglu', 'Affiliation': 'Department of Vascular Surgery, Buffalo VA Medical Center, Buffalo, NY.'}, {'ForeName': 'Eugene S', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Department of Vascular Surgery, Sacramento VA Medical Center, Mather, CA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Raffetto', 'Affiliation': 'Department of Vascular Surgery, West Roxbury VA Medical Center, West Roxbury, MA.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Henke', 'Affiliation': 'Department of Vascular Surgery, VA Ann Arbor Healthcare System, Ann Arbor, MI.'}, {'ForeName': 'Gale S', 'Initials': 'GS', 'LastName': 'Tang', 'Affiliation': 'Department of Vascular Surgery, VA Puget Sound Health Care System, Seattle, WA.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Mureebe', 'Affiliation': 'Department of Vascular Surgery, Durham VA Health Care System, Durham, NC.'}, {'ForeName': 'Panagoitis', 'Initials': 'P', 'LastName': 'Kougias', 'Affiliation': 'Department of Vascular Surgery, Michael E. DeBakey VA Medical Center, Houston, TX.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Johanning', 'Affiliation': 'Department of Vascular Surgery, Omaha VA Medical Center-VA Nebraska-Western Iowa HCS, Omaha, NE.'}, {'ForeName': 'Shipra', 'Initials': 'S', 'LastName': 'Arya', 'Affiliation': 'Department of Vascular Surgery, Atlanta VA Medical Center, Decatur, GA.'}, {'ForeName': 'Salvatore T', 'Initials': 'ST', 'LastName': 'Scali', 'Affiliation': 'Department of Vascular Surgery, Malcom Randall VA Medical Center, Gainesville, FL.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Stone', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Bjoern D', 'Initials': 'BD', 'LastName': 'Suckow', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Orion', 'Affiliation': 'Department of Vascular Surgery, West Haven VA Medical Center, West Haven, CT.'}, {'ForeName': 'Vivienne', 'Initials': 'V', 'LastName': 'Halpern', 'Affiliation': 'Department of Vascular Surgery, Phoenix VA Health Care System, Phoenix, AZ.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Vascular Surgery, West Los Angeles Medical Center, Los Angeles, CA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Inhat', 'Affiliation': 'Department of Vascular Surgery, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nelson', 'Affiliation': ""Department of Vascular Surgery, James A. Haley Veterans' Hospital, Tampa, FL.""}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Tzeng', 'Affiliation': 'Department of Vascular Surgery, VA Pittsburg Healthcare System, Pittsburg, PA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Vascular Surgery, Southern Arizona VA Health Care System, Tucson, AZ.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Barry', 'Affiliation': 'Massachusetts General Hospital Center for Shared Decision Making, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Sirovich', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT.'}, {'ForeName': 'Philip P', 'Initials': 'PP', 'LastName': 'Goodney', 'Affiliation': 'Department of Surgery and VA Outcomes Group, White River Junction VA Medical Center, White River Junction, VT. Electronic address: Philip.goodney@hitchcock.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of vascular surgery,['10.1016/j.avsg.2019.02.034']
677,31068015,"Effects of an adjunctive, chronotype-based light therapy in hospitalized patients with severe burnout symptoms - a pilot study.","Light therapy is a well-established treatment option for seasonal affective disorders and is effective in reducing sleep problems and daytime fatigue. Symptoms of severe burnout include feelings of exhaustion and impaired sleep and mood. Thus, light therapy seems promising for burnout treatment. So far, light therapy effects in burnout were investigated in outpatient settings only, with inconclusive results. The present study targeted light therapy effects in an inpatient setting. Participants with severe burnout were recruited in two psychosomatic clinics and randomly assigned to a control group with multimodal psychiatric treatment or an add-on light treatment group. Participants in the latter group were additionally exposed to morning bright light (illuminance: 4246 lux, irradiance: 1802.81 µW.cm -2 ) for 3 weeks, 30 minutes a day, timed to their chronotypes. Light effects on burnout symptoms, depression, well-being, daytime sleepiness, sleep quality, and attentional performance were measured twice (pre-/postintervention design). Adjunctive chronotype-based bright light therapy was well tolerated and improved burnout symptoms and well-being without additional effect on severity of depression. Furthermore, reduced daytime sleepiness, improved nighttime sleep quality, a sleep phase advance of 25 minutes, shortened sleep latency, less sleep disturbances and increased sleep duration were observed in the light treatment group. No group differences were found in attentional performance. Chronotype-based bright light therapy seems to be effective in improving burnout symptoms and sleep problems in patients with severe burnout symptoms. Further studies with larger sample sizes and objective measures of sleep are necessary to confirm these preliminary results before practical recommendations can be made.",2019,Adjunctive chronotype-based bright light therapy was well tolerated and improved burnout symptoms and well-being without additional effect on severity of depression.,"['patients with severe burnout symptoms', 'Participants with severe burnout were recruited in two psychosomatic clinics', 'hospitalized patients with severe burnout symptoms - a pilot study']","['Light therapy', 'Adjunctive chronotype-based bright light therapy', 'adjunctive, chronotype-based light therapy', 'control group with multimodal psychiatric treatment or an add-on light treatment group', 'Chronotype-based bright light therapy']","['attentional performance', 'reduced daytime sleepiness, improved nighttime sleep quality, a sleep phase advance of 25\xa0minutes, shortened sleep latency, less sleep disturbances and increased sleep duration', 'burnout symptoms, depression, well-being, daytime sleepiness, sleep quality, and attentional performance', 'Symptoms of severe burnout include feelings of exhaustion and impaired sleep and mood']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0230842,Adjunctive chronotype-based bright light therapy was well tolerated and improved burnout symptoms and well-being without additional effect on severity of depression.,"[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Canazei', 'Affiliation': 'a Research Department , Bartenbach GmbH , Aldrans , Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bassa', 'Affiliation': 'b Department of Psychology , Karl-Franzens-Universitat Graz.'}, {'ForeName': 'Paulino', 'Initials': 'P', 'LastName': 'Jimenez', 'Affiliation': 'b Department of Psychology , Karl-Franzens-Universitat Graz.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Papousek', 'Affiliation': 'b Department of Psychology , Karl-Franzens-Universitat Graz.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fink', 'Affiliation': 'b Department of Psychology , Karl-Franzens-Universitat Graz.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Weiss', 'Affiliation': 'c Department of Psychology , University of Graz , Graz , Austria.'}]",Chronobiology international,['10.1080/07420528.2019.1604539']
678,31711513,Autologous adipose-derived stromal cell treatment for patients with refractory angina (MyStromalCell Trial): 3-years follow-up results.,"BACKGROUND


Stem cell therapy is investigated as a treatment option for patients with ischemic heart disease. In this study, long-term safety and efficacy of autologous intra-myocardial injections of adipose-derived stromal cells (ASCs) was studied in patients with refractory angina.
METHODS


Sixty patients with coronary artery stenosis and preserved left ventricular ejection fraction were 2:1 randomised to intramyocardial injections of ASCs or saline and followed for 3 years.
RESULTS


For patients in the ASC group, the bicycle exercise time and the exercise performance in watt were un-changed (383 ± 30 s to 370 ± 44 s, P = 0.052 and 81 ± 6 to 78 ± 10, P = 0.123, respectively), but the performance in METs was reduced significantly (4.2 ± 0.3 to 4.0 ± 0.4, P = 0.027) during the follow-up period. However, in the same period, there was in the placebo group a significant decline in bicycle exercise time (437 ± 53 s to 383 ± 58 s, P = 0.001), the exercise performance measured in watt (87 ± 12 W to 80 ± 12 W, P = 0.019) and in METs (4.5 ± 0.4 to 4.1 ± 0.4, P = 0.002). Moreover, angina measured as CCS class was significantly reduced in the ASC group but not in the placebo group (2.5 ± 0.9 to 1.8 ± 1.2, P = 0.002 and 2.5 ± 0.8 to 2.1 ± 1.3, P = 0.186, respectively). However, no significant change was observed between the two groups.
CONCLUSIONS


Patients receiving ASCs had improved cardiac symptoms and unchanged exercise capacity, in opposition to deterioration in the placebo group. Trial registration ClinicalTrials.gov Identifier: NCT01449032. Registered 7 October 2011-Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/NCT01449032?term=jens+kastrup&rank=7.",2019,"For patients in the ASC group, the bicycle exercise time and the exercise performance in watt were un-changed (383 ± 30 s to 370 ± 44 s, P = 0.052 and 81 ± 6 to 78 ± 10, P = 0.123, respectively), but the performance in METs was reduced significantly (4.2 ± 0.3 to 4.0 ± 0.4, P = 0.027) during the follow-up period.","['patients with refractory angina', 'Sixty patients with coronary artery stenosis and preserved left ventricular ejection fraction', 'patients with ischemic heart disease', 'patients with refractory angina (MyStromalCell Trial']","['placebo', 'Autologous adipose-derived stromal cell treatment', 'intramyocardial injections of ASCs or saline', 'autologous intra-myocardial injections of adipose-derived stromal cells (ASCs']","['CCS class', 'performance in METs', 'cardiac symptoms and unchanged exercise capacity', 'bicycle exercise time and the exercise performance', 'exercise performance', 'bicycle exercise time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0741032', 'cui_str': 'Refractory angina'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]","[{'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0439587', 'cui_str': 'Exercise time (qualifier value)'}]",60.0,0.177572,"For patients in the ASC group, the bicycle exercise time and the exercise performance in watt were un-changed (383 ± 30 s to 370 ± 44 s, P = 0.052 and 81 ± 6 to 78 ± 10, P = 0.123, respectively), but the performance in METs was reduced significantly (4.2 ± 0.3 to 4.0 ± 0.4, P = 0.027) during the follow-up period.","[{'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Qayyum', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Inge Lehmanns Vej 7, 2100, Copenhagen, Denmark. abbas.ali.qayyum@regionh.dk.'}, {'ForeName': 'Anders Bruun', 'Initials': 'AB', 'LastName': 'Mathiasen', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Inge Lehmanns Vej 7, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Inge Lehmanns Vej 7, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiology, Gentofte University of Copenhagen, Kildegårdsvej 28, 2900, Hellerup, Denmark.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Haack-Sørensen', 'Affiliation': 'Cardiology Stem Cell Centre 9302, Rigshospitalet University of Copenhagen, Henrik Harpestrengsvej 4C, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ekblond', 'Affiliation': 'Cardiology Stem Cell Centre 9302, Rigshospitalet University of Copenhagen, Henrik Harpestrengsvej 4C, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Inge Lehmanns Vej 7, 2100, Copenhagen, Denmark.'}]",Journal of translational medicine,['10.1186/s12967-019-2110-1']
679,31732851,"A single dose of purple grape juice improves physical performance and antioxidant activity in runners: a randomized, crossover, double-blind, placebo study.","PURPOSE


To investigate the effects of a single dose of juice on physical performance, oxidative stress, inflammation and muscle damage in runners.
METHODS


Fourteen recreational male runners (39 ± 9 years, VO 2peak  = 55.9 ± 6.5 ml/kg/min) performed two running tests to exhaustion at 80% of VO 2max  after ingesting grape juice or a placebo drink (10 ml/kg/day) randomly. Blood samples were taken before and 2 h after supplementation and immediately after running to analyze total antioxidant capacity (TAC), malondialdehyde (MDA), alpha-1 acid glycoprotein (A1GPA), high-sensitivity C-reactive protein (hs-CRP), creatine kinase (CK) and lactate dehydrogenase (LDH).
RESULTS


The participants ran for an average of 59.2 ± 27.8 min until exhaustion in the placebo group and for 68.4 ± 29.7 min until exhaustion in the grape juice intake group, which was a significantly longer time (p = 0.008). This improvement in physical performance was accompanied by a 43.6% increase in TAC (p = 0.000) at the post-exercise timepoint compared to the level at baseline. MDA, A1GPA, hs-CRP, CK, and LDH did not exhibit changes. In contrast, no significant change in any variable was observed after consuming the placebo drink.
CONCLUSION


The single-dose intake of purple grape juice demonstrated an ergogenic effect in recreational runners by increasing run time to exhaustion and increasing antioxidant activity.",2020,This improvement in physical performance was accompanied by a 43.6% increase in TAC (p = 0.000) at the post-exercise timepoint compared to the level at baseline.,"['runners', 'Fourteen recreational male runners (39\u2009±\u20099\xa0years, VO 2peak \u2009=\u200955.9\u2009±\u20096.5\xa0ml/kg/min) performed two', 'recreational runners']","['purple grape juice', 'placebo', 'running tests to exhaustion at 80% of VO 2max  after ingesting grape juice or a placebo drink', 'juice']","['TAC', 'total antioxidant capacity (TAC), malondialdehyde (MDA), alpha-1 acid glycoprotein (A1GPA), high-sensitivity C-reactive protein (hs-CRP), creatine kinase (CK) and lactate dehydrogenase (LDH', 'physical performance, oxidative stress, inflammation and muscle damage', 'MDA, A1GPA, hs-CRP, CK, and LDH', 'physical performance', 'physical performance and antioxidant activity']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0439542', 'cui_str': 'Purple color'}, {'cui': 'C0452455', 'cui_str': 'Grape juice (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}]","[{'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0029297', 'cui_str': 'alpha 1-Acid Glycoprotein'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}, {'cui': 'C2607857'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.473247,This improvement in physical performance was accompanied by a 43.6% increase in TAC (p = 0.000) at the post-exercise timepoint compared to the level at baseline.,"[{'ForeName': 'Lydiane', 'Initials': 'L', 'LastName': 'de Lima Tavares Toscano', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Alexandre Sérgio', 'Initials': 'AS', 'LastName': 'Silva', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil. alexandresergiosilva@yahoo.com.br.'}, {'ForeName': 'Ana Carla Lima', 'Initials': 'ACL', 'LastName': 'de França', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Bruno Rafael Virgínio', 'Initials': 'BRV', 'LastName': 'de Sousa', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Eder Jackson Bezerra', 'Initials': 'EJB', 'LastName': 'de Almeida Filho', 'Affiliation': 'Laboratório de Estudos do Treinamento Físico Aplicado ao Desempenho e a Saúde, Departamento de Educação Física, Universidade Federal da Paraíba (UFPB), Centro de Ciências da Saúde, Campus I, Cidade Universitária, João Pessoa, Paraíba, CEP 58059-900, Brazil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'da Silveira Costa', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil.'}, {'ForeName': 'Aline Telles Biasoto', 'Initials': 'ATB', 'LastName': 'Marques', 'Affiliation': 'Empresa Brasileira de Pesquisa Agropecuária, Embrapa Semiárido, Petrolina, Pernambuco, Brazil.'}, {'ForeName': 'Darcilene Fiuza', 'Initials': 'DF', 'LastName': 'da Silva', 'Affiliation': 'Faculdade de Farmácia, Universidade Federal da Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Klécia', 'Initials': 'K', 'LastName': 'de Farias Sena', 'Affiliation': 'Laboratório de Estudos do Treinamento Físico Aplicado ao Desempenho e a Saúde, Departamento de Educação Física, Universidade Federal da Paraíba (UFPB), Centro de Ciências da Saúde, Campus I, Cidade Universitária, João Pessoa, Paraíba, CEP 58059-900, Brazil.'}, {'ForeName': 'Gilberto Santos', 'Initials': 'GS', 'LastName': 'Cerqueira', 'Affiliation': 'Departamento de Morfologia, Universidade Federal do Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'da Conceição Rodrigues Gonçalves', 'Affiliation': 'Programa de Pós-graduação em Ciências da Nutrição, Universidade Federal da Paraíba (UFPB), João Pessoa, Paraíba, Brazil.'}]",European journal of nutrition,['10.1007/s00394-019-02139-6']
680,31033228,"Low-Load Resistance Training With Blood-Flow Restriction in Relation to Muscle Function, Mass, and Functionality in Women With Rheumatoid Arthritis.","OBJECTIVE


To evaluate the effects of a low-load resistance training program associated with partial blood-flow restriction in patients with rheumatoid arthritis (RA).
METHODS


Forty-eight women with RA were randomized into 1 of 3 groups: high-load resistance training (HL-RT; 70% 1 repetition maximum [1RM]), low-load resistance training (30% 1RM) with partial blood-flow restriction training (BFRT), and a control group. Patients completed a 12-week supervised training program and were assessed for lower-extremity 1RM, quadriceps cross-sectional area (CSA), physical function (timed-stands test [TST], timed-up-and-go test [TUG], and Health Assessment Questionnaire [HAQ]), and quality of life (Short Form 36 health survey [SF-36]) at baseline and after the intervention.
RESULTS


BFRT and HL-RT were similarly effective in increasing maximum dynamic strength in both leg press (22.8% and 24.2%, respectively; P < 0.0001 for all) and knee extension (19.7% and 23.8%, respectively; P < 0.0001 for all). Quadriceps CSA was also significantly increased in both BFRT and HL-RT (9.5% and 10.8%, respectively; P < 0.0001 for all). Comparable improvements in TST (11.2% and 14.7%; P < 0.0001 for all) and TUG (-6.8% [P < 0.0053] and -8.7% [P < 0.0001]) were also observed in BFRT and HL-RT, respectively. Improvements in both groups were significantly greater than those of the control group (P < 0.05 for all). SF-36 role physical and bodily pain and HAQ scores were improved only in BFRT (45.7%, 22.5%, and -55.9%, respectively; P < 0.05 for all). HL-RT resulted in 1 case of withdrawal and several cases of exercise-induced pain, which did not occur in BFRT.
CONCLUSION


BFRT was effective in improving muscle strength, mass, function, and health-related quality of life in patients with RA, emerging as a viable therapeutic modality in RA management.",2020,"SF-36 role physical, bodily pain and HAQ scores were improved only in BFRT (+45.7%, +22.5% and -55.9%, respectively; all p<0.05).","['Forty-eight women with RA', 'patients with rheumatoid arthritis (RA', 'women with rheumatoid arthritis']","['low-load resistance training program', 'high-load resistance training (HL-RT: 70% one repetition maximum [1RM]); low-load resistance training (30% 1RM) with partial blood flow restriction (BFRT) and control group', 'supervised training program', 'Low-load resistance training with blood flow restriction', 'BFRT']","['knee extension', 'SF-36 role physical, bodily pain and HAQ scores', 'Quadriceps CSA', 'muscle strength, mass, function and health-related quality of life', 'partial blood flow restriction', 'maximal dynamic strength', 'TUG', 'lower-limb 1RM, quadriceps cross-sectional area (CSA), physical function (timed-stands test [TST], timed-up-and-go test [TUG], Health Assessment Questionnaire [HAQ]) and quality of life (Short Form Health Survey [SF-36', 'TST']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",48.0,0.0203149,"SF-36 role physical, bodily pain and HAQ scores were improved only in BFRT (+45.7%, +22.5% and -55.9%, respectively; all p<0.05).","[{'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Ferraz', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ceci O', 'Initials': 'CO', 'LastName': 'Kurimori', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lissiane K', 'Initials': 'LK', 'LastName': 'Guedes', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fernanda R', 'Initials': 'FR', 'LastName': 'Lima', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'de Sá-Pinto', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Universidade de São Paulo, São Paulo, Brazil.'}]",Arthritis care & research,['10.1002/acr.23911']
681,31037994,"Influence of rabeprazole and famotidine on pharmacodynamic profile of dual antiplatelet therapy in clopidogrel-sensitive patients: The randomized, prospective, PROTECT trial.","Although acid suppressants are needed to attenuate gastrointestinal bleeding (GIB) after percutaneous coronary intervention (PCI), pharmacodynamic interaction between clopidogrel and proton pump inhibitor (PPI) can increase the risk of high platelet reactivity (HPR). We sought to evaluate serial changes of platelet measures and influence of rabeprazole on platelet measures. After 600-mg clopidogrel loading for elective PCI, clopidogrel-sensitive patients were recruited and randomly assigned to add rabeprazole of daily 20 mg (n = 40) or famotidine of daily 40 mg (n = 40). Platelet measures were performed with light transmittance aggregometry and VASP-P assay. Primary endpoint was 5 μM ADP-induced platelet aggregation (PA) at 30-day follow-up. HPR was defined as 5 μM ADP-induced PA > 46%. Baseline platelet measures did not differ significantly between the groups. The 30-day level of 5 μM ADP-induced PA was similar between the famotidine vs. rabeprazole group (30.0 ± 16.4% vs. 30.2 ± 13.9%,  P = .956). In addition, other platelet measures were comparable between the groups. At 30-day follow-up, the incidence of HPR was similar between the famotidine and rabeprazole groups (20.5% vs. 15.4%;  P = .555). In conclusion, adjunctive use of rabeprazole showed the similar antiplatelet effect even in clopidogrel-sensitive patients compared with adjunctive famotidine, which may support the similar effect of rabeprazole and famotidine on the antiplatelet effect of dual antiplatelet therapy with clopidogrel plus aspirin.",2020,"At 30-day follow-up, the incidence of HPR was similar between the famotidine and rabeprazole groups (20.5% vs. 15.4%; P= .555).","['clopidogrel-sensitive patients', 'After 600-mg clopidogrel loading for elective PCI, clopidogrel-sensitive patients']","['clopidogrel plus aspirin', 'rabeprazole', 'clopidogrel and proton pump inhibitor (PPI', 'rabeprazole and famotidine', 'famotidine', 'famotidine vs. rabeprazole']","['5 μM ADP-induced platelet aggregation (PA', 'HPR', 'incidence of HPR', 'Baseline platelet measures', '30-day level of 5 μM ADP-induced PA']","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0015620', 'cui_str': 'Famotidine'}]","[{'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0280222,"At 30-day follow-up, the incidence of HPR was similar between the famotidine and rabeprazole groups (20.5% vs. 15.4%; P= .555).","[{'ForeName': 'Jong-Hwa', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital, Changwon, South Korea.'}, {'ForeName': 'Yongwhi', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital, Changwon, South Korea.'}, {'ForeName': 'Jae Seok', 'Initials': 'JS', 'LastName': 'Bae', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital, Changwon, South Korea.'}, {'ForeName': 'Jeong Yoon', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital, Changwon, South Korea.'}, {'ForeName': 'Kye-Hwan', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Min Gyu', 'Initials': 'MG', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Jin-Sin', 'Initials': 'JS', 'LastName': 'Koh', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Jeong Rang', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Seok-Jae', 'Initials': 'SJ', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Choong Hwan', 'Initials': 'CH', 'LastName': 'Kwak', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital, Changwon, South Korea.'}, {'ForeName': 'Jin-Yong', 'Initials': 'JY', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, South Korea.'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine and Cardiovascular Center, Gyeongsang National University Changwon Hospital, Changwon, South Korea.'}]",Platelets,['10.1080/09537104.2019.1609667']
682,31676259,Hydration status affects thirst and salt preference but not energy intake or postprandial ghrelin in healthy adults: A randomised crossover trial.,"BACKGROUND


Few studies have investigated the effect of hydration status on appetite for food in healthy adults. Prior work suggests hydration status does not alter appetite or energy intake, with mixed findings regarding appetite hormone secretion. However, an extensive investigation into both the psychological and physiological appetitive responses to hydration status has never been conducted.
OBJECTIVE


To investigate the effect of hydration status on multiple facets of appetite.
DESIGN


After 3 days pre-trial standardization, a range of appetite tasks were conducted when hypohydrated (HYPO) and euhydrated (EUHY) in 16 healthy participants (8 men). Hydration status was manipulated via dehydration in a heat tent for 60 min and subsequent fluid restriction (HYPO) or replacement (EUHY). The next day, a food reward computer task was completed followed by an ad libitum pasta meal. Pre- and post-prandial visual analogue scales assessing hunger, fullness, and flavour desires (sweet, salty, savoury and fatty) were additionally completed. Blood samples were taken the previous day before the hydration interventions in a euhydrated state, and in the fasted and post-prandial state during HYPO and EUHY.
RESULTS


HYPO induced -1.9 ± 1.2% body mass change, compared to -0.2 ± 0.6% , with accompanying changes in markers of hypohydration which were not seen during EUHY. A higher desire for foods was associated with a higher water content but the association was weaker in EUHY compared to HYPO, (β= -0.33 mm/g of food water content, p < 0.001) in the food reward task. Visual analogue scales showed similar hunger and fullness between interventions, but during HYPO there was consistently higher thirst (average range in difference 27-32 mm across all time points) and lower fasted desire for salt (-23, 95% CI -10, -35 mm). Ad libitum energy intake (HYPO 1953 ± 742 kJ, EUHY 2027 ± 926 kJ; p = 0.542) and post-prandial ghrelin concentrations (HYPO 180 ± 65 pg mL -1 , EUHY 188 ± 71 pg mL -1 ; p = 0.736) were similar by hydration status.
CONCLUSIONS


An acute manipulation to hydration status altered desire for salt and foods of differing water contents, but did not influence energy intake at an ad libitum pasta meal. Further research should investigate whether these appetites would alter food choice.",2019,"An acute manipulation to hydration status altered desire for salt and foods of differing water contents, but did not influence energy intake at an ad libitum pasta meal.","['healthy adults', '16 healthy participants (8 men']",[],"['Pre- and post-prandial visual analogue scales', 'assessing hunger, fullness, and flavour desires (sweet, salty, savoury and fatty', 'hunger and fullness']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}]",16.0,0.0648299,"An acute manipulation to hydration status altered desire for salt and foods of differing water contents, but did not influence energy intake at an ad libitum pasta meal.","[{'ForeName': 'Harriet A', 'Initials': 'HA', 'LastName': 'Carroll', 'Affiliation': 'Department for Health, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom; Rowett Institute, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Ashgrove Road West, Aberdeen, AB25 3BQ, United Kingdom. Electronic address: hc12591@my.bristol.ac.uk.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom. Electronic address: iain.templeman@gmail.com.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan; Institute for Research Excellence in Learning Science, National Taiwan Normal University, Taipei, Taiwan. Electronic address: yc.chen@ntnu.edu.tw.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Edinburgh', 'Affiliation': 'Department for Health, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom. Electronic address: r.m.edinburgh@bath.ac.uk.'}, {'ForeName': 'Elaine K', 'Initials': 'EK', 'LastName': 'Burch', 'Affiliation': 'Department for Health, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'Jake T', 'Initials': 'JT', 'LastName': 'Jewitt', 'Affiliation': 'Department for Health, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'Georgie', 'Initials': 'G', 'LastName': 'Povey', 'Affiliation': 'Department for Health, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Robinson', 'Affiliation': 'Department for Health, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Dooley', 'Affiliation': 'Department for Health, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': 'Automatic Control and Systems Engineering, University of Sheffield, S1 4DT, United Kingdom. Electronic address: c.m.buckley@sheffield.ac.uk.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'School of Psychological Science, University of Bristol, 12a, Priory Road, Bristol, BS8 1TU, United Kingdom. Electronic address: peter.rogers@bristol.ac.uk.'}, {'ForeName': 'Widet', 'Initials': 'W', 'LastName': 'Gallo', 'Affiliation': 'Department of Clinical Sciences, Lund University, Lund, Box 117, 221 00, Sweden. Electronic address: widet.gallo@med.lu.se.'}, {'ForeName': 'Olle', 'Initials': 'O', 'LastName': 'Melander', 'Affiliation': 'Department of Clinical Sciences, Lund University, Lund, Box 117, 221 00, Sweden. Electronic address: olle.melander@med.lu.se.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom. Electronic address: d.thompson@bath.ac.uk.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Epinal Way, Loughborough, Leicestershire, LE11 3TU, United Kingdom. Electronic address: l.james@lboro.ac.uk.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'School for Policy Studies, University of Bristol, 8 Priory Road, Bristol, BS8 1TZ, United Kingdom. Electronic address: laura.johnson@bristol.ac.uk.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Claverton Down, Bath, BA2 7AY, United Kingdom. Electronic address: j.betts@bath.ac.uk.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112725']
683,30794143,Increasing Mobility via In-hospital Ambulation Protocol Delivered by Mobility Technicians: A Pilot Randomized Controlled Trial.,"BACKGROUND


Ambulating medical inpatients may improve outcomes, but this practice is often overlooked by nurses who have competing clinical duties.
OBJECTIVE


This study aimed to assess the feasibility and effectiveness of dedicated mobility technician-assisted ambulation in older inpatients.
DESIGN


This study was a single-blind randomized controlled trial.
SETTING


Patients aged ≥60 years and admitted as medical inpatients to a tertiary care center were recruited.
INTERVENTION


Patients were randomized into two groups to participate in the ambulation protocol administered by a dedicated mobility technician. Usual care patients were not seen by the mobility technician but were not otherwise restricted in their opportunity to ambulate.
MEASUREMENTS


Primary outcomes were length of stay and discharge disposition. Secondary outcomes included change in mobility measured by six-clicks score, daily steps measured by Fitbit, and 30-day readmission.
RESULTS


Control (n = 52) and intervention (n = 50) groups were not significantly different at baseline. Of patients randomized to the intervention group, 74% participated at least once. Although the intervention did not affect the primary outcomes, the intervention group took nearly 50% more steps than the control group (P = .04). In the per protocol analysis, the six-clicks score significantly increased (P = .04). Patients achieving ≥400 steps were more likely to go home (71% vs 46%, P = .01).
CONCLUSIONS


Attempted ambulation three times daily overseen by a dedicated mobility technician was feasible and increased the number of steps taken. A threshold of 400 steps was predictive of home discharge. Further studies are needed to establish the appropriate step goal and the effect of assisted ambulation on hospital outcomes.",2019,"Patients achieving ≥400 steps were more likely to go home (71% vs 46%, P = .01).
","['Control (n = 52) and intervention (n = 50', 'Ambulating medical inpatients', 'Patients aged ≥60 years and admitted as medical inpatients to a tertiary care center were recruited', 'older inpatients']","['dedicated mobility technician-assisted ambulation', 'ambulation protocol administered by a dedicated mobility technician']","['number of steps taken', 'six-clicks score', 'feasibility and effectiveness', 'length of stay and discharge disposition', 'change in mobility measured by six-clicks score, daily steps measured by Fitbit, and 30-day readmission']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}]",,0.128599,"Patients achieving ≥400 steps were more likely to go home (71% vs 46%, P = .01).
","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Hamilton', 'Affiliation': 'Department of Hospital Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Medicine Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Stilphen', 'Affiliation': 'Rehabilitation and Sports Therapy, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schramm', 'Affiliation': 'Center for Value-Based Care Research, Medicine Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Frost', 'Affiliation': 'Physical Medicine and Rehabilitation, Cleveland Clinic, Cleve-land, Ohio.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Fox', 'Affiliation': 'Center for Value-Based Care Research, Medicine Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Rothberg', 'Affiliation': 'Center for Value-Based Care Research, Medicine Institute, Cleveland Clinic, Cleveland, Ohio.'}]",Journal of hospital medicine,['10.12788/jhm.3153']
684,30612854,"A randomized, double-blind, placebo-controlled trial of lamotrigine for prescription corticosteroid effects on the human hippocampus.","In animals, stress and corticosteroid excess are associated with decreases in memory performance and hippocampal volume that may be prevented with agents that decrease glutamate release. Humans also demonstrate changes in memory and hippocampus with corticosteroids. In this report the effects of glutamate-release inhibitor lamotrigine on hippocampal structure and memory were examined in people receiving medically needed prescription corticosteroid therapy. A total of 54 outpatient adults (n = 28 women) receiving chronic (≥ 6 months) oral corticosteroid therapy were randomized to lamotrigine or placebo for 48 weeks. Declarative memory was assessed using the Rey Auditory Verbal Learning Test (RAVLT); structural magnetic resonance imaging (MRI) as well as single-voxel proton MR spectroscopy ( 1 HMRS) focused on hippocampus were obtained at baseline and week 48. Utilizing a mixed-model approach, structural and biochemical data were examined by separate ANOVAs, and memory was assessed with a multi-level longitudinal model. RAVLT total scores demonstrated significantly better declarative memory performance with lamotrigine than placebo (p = 0.047). Hippocampal subfield volumes were not significantly different between the treatment groups. In summary, lamotrigine was associated with less decline in declarative memory performance than placebo in corticosteroid-treated patients. Findings suggest that, in humans as well as in animal models, glutamate release inhibitors may attenuate some of the effects on the human memory associated with corticosteroids.",2019,RAVLT total scores demonstrated significantly better declarative memory performance with lamotrigine than placebo (p = 0.047).,"['people receiving medically needed prescription corticosteroid therapy', '54 outpatient adults (n\u202f=\u202f28 women) receiving chronic (≥\u202f6 months) oral', 'human hippocampus']","['placebo', 'corticosteroid therapy', 'lamotrigine', 'glutamate-release inhibitor lamotrigine', 'lamotrigine or placebo']","['Hippocampal subfield volumes', 'Rey Auditory Verbal Learning Test (RAVLT); structural magnetic resonance imaging (MRI', 'Declarative memory', 'hippocampal structure and memory', 'declarative memory performance', 'memory performance and hippocampal volume']","[{'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}]",54.0,0.322321,RAVLT total scores demonstrated significantly better declarative memory performance with lamotrigine than placebo (p = 0.047).,"[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States. Electronic address: Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Nasreen', 'Initials': 'N', 'LastName': 'Sayed', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Department of the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California, Irvine, United States.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California, Irvine, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California, Irvine, United States.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Sunderajan', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'McEwen', 'Affiliation': 'The Harold and Margaret Milliken Hatch Laboratory of Neuroendocrinology, Rockefeller University, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas 75390-8849, TX, United States.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2018.12.012']
685,31029989,"Thoracolumbar interfascial plane block provides effective perioperative pain relief for patients undergoing lumbar spinal surgery; a prospective, randomized and double blinded trial.","STUDY OBJECTIVE


Background: Although bilateral ultrasound-guided thoracolumbar interfascial plane (TLIP) block provides effective analgesia to the lumbar spinal region, a few previous studies for the TLIP block have only been reported up to the present. We aimed to study whether the TLIP block in combination with general anesthesia would provide more effective pain relief compared to general anesthesia alone.
DESIGN


Prospective randomized controlled trial.
SETTING


Operation and recovery room, hospital ward.
PATIENTS


Seventy-two patients undergoing primary lumbar laminoplasty of less than three levels between May 2016 and April 2017.
INTERVENTIONS


Seventy-two patients undergoing primary lumbar laminoplasty of less than three levels were randomly allocated to receive either the TLIP block combined with general anesthesia (T group, n = 35) or general anesthesia alone (C group, n = 34).
MEASUREMENT


The primary outcome measured the cumulative amount of fentanyl delivered to the patients through PCA within 48 h after the end of surgery. Secondary outcomes measured the number of delivered and requested PCA doses and VAS pain scores at the surgical site obtained at rest as well as with movement at specific time points within 48 h after the surgery.
MAIN RESULTS


During the first 48 h after surgery, the cumulative amount of delivered fentanyl (mean [standard deviation]) (μg) was lower in the T group (198.3 [103.1]) (μg) than in the C group (452.9 [175.4]) (μg) (P < 0.001). The number of delivered and requested PCA doses and the VAS pain scores was also lower in the T group than in the C group at all time points (all data were less than P < 0.05).
CONCLUSIONS


Bilateral TLIP block combined with general anesthesia provides more effective perioperative pain relief than that provided by general anesthesia alone in patients who undergo lumbar spinal surgery.",2019,"The number of delivered and requested PCA doses and the VAS pain scores was also lower in the T group than in the C group at all time points (all data were less than P < 0.05).
","['Seventy-two patients undergoing primary lumbar laminoplasty of less than three levels', 'patients undergoing lumbar spinal surgery', 'patients who undergo lumbar spinal surgery', 'Seventy-two patients undergoing primary lumbar laminoplasty of less than three levels between May 2016 and April 2017', 'Operation and recovery room, hospital ward']","['Thoracolumbar interfascial plane block', 'bilateral ultrasound-guided thoracolumbar interfascial plane (TLIP) block', 'TLIP block combined with general anesthesia (T group, n\u202f=\u202f35) or general anesthesia alone (C group, n\u202f=\u202f34']","['cumulative amount of delivered fentanyl', 'cumulative amount of fentanyl delivered to the patients through PCA', 'number of delivered and requested PCA doses and the VAS pain scores', 'effective pain relief', 'number of delivered and requested PCA doses and VAS pain scores at the surgical site obtained at rest as well as with movement at specific time points', 'effective perioperative pain relief']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1535956', 'cui_str': 'Laminoplasty'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}]","[{'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",72.0,0.128418,"The number of delivered and requested PCA doses and the VAS pain scores was also lower in the T group than in the C group at all time points (all data were less than P < 0.05).
","[{'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Ueshima', 'Affiliation': 'Department of Anesthesiology, Showa University Hospital, Tokyo, Japan. Electronic address: ueshimhi@med.showa-u.ac.jp.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Hara', 'Affiliation': 'Department of Anesthesiology, Showa University Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Otake', 'Affiliation': 'Department of Anesthesiology, Showa University Hospital, Tokyo, Japan.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.04.026']
686,31030165,"Pinitol consumption improves liver health status by reducing oxidative stress and fatty acid accumulation in subjects with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial.","Non-alcoholic fatty liver disease (NAFLD) is the most prevalent cause of chronic hepatic injury in the world. One of the most important therapeutic strategies for this disease is modulating oxidative stress. This study hypothesized that supplementation of pinitol might exert hepatic protective effects, by modulating oxidative stress in subjects with NAFLD. A randomized, double-blind controlled trial was conducted in 90 subjects with ultrasonography-proven NAFLD, who were randomly assigned to the placebo, low-dose (300 mg/d), or high-dose (500 mg/d) of pinitol for 12 weeks. The outcome measures were liver fat content, liver enzymes, fasting and postprandial lipids, and oxidative stress levels. To understand the underlying mechanism, plasma metabolomic analysis based on a gas chromatography/time-of-flight mass spectrometry and urinary pinitol analysis were also performed. The pinitol group showed significantly lower levels in liver fat content, plasma liver enzymes, fasting/postprandial urinary malondialdehyde levels, and postprandial triglycerides concentrations, but significantly higher in glutathione peroxidase level compared with the placebo group. The metabolomic analysis identified 27 differential metabolites involved in glycine/serine/threonine metabolism, alanine/aspartate/glutamate metabolism, D-glutamine/D-glutamate metabolism, and fatty acid synthesis, implicating the role of pinitol in glutathione-related lipid and energy metabolism. These results suggest that pinitol may exert modulatory effects upon energy and metabolic pathways by reducing oxidative stress and fatty acid accumulation, which can lead to hepatoprotective benefits in NAFLD subjects.",2019,"The pinitol group showed significantly lower levels in liver fat content, plasma liver enzymes, fasting/postprandial urinary malondialdehyde levels, and postprandial triglycerides concentrations, but significantly higher in glutathione peroxidase level compared with the placebo group.","['subjects with non-alcoholic fatty liver disease', '90 subjects with ultrasonography-proven NAFLD', 'subjects with NAFLD']","['Pinitol consumption', 'placebo']","['liver fat content, plasma liver enzymes, fasting/postprandial urinary malondialdehyde levels, and postprandial triglycerides concentrations', 'liver fat content, liver enzymes, fasting and postprandial lipids, and oxidative stress levels', 'oxidative stress and fatty acid accumulation', 'glutathione peroxidase level', 'liver health status']","[{'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}]","[{'cui': 'C0071094', 'cui_str': 'pinitol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",90.0,0.441752,"The pinitol group showed significantly lower levels in liver fat content, plasma liver enzymes, fasting/postprandial urinary malondialdehyde levels, and postprandial triglycerides concentrations, but significantly higher in glutathione peroxidase level compared with the placebo group.","[{'ForeName': 'Eunok', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Republic of Korea.'}, {'ForeName': 'Yeni', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Republic of Korea.'}, {'ForeName': 'Sung Won', 'Initials': 'SW', 'LastName': 'Kwon', 'Affiliation': 'CHA Bundang Medical Center, CHA University, Seongnam, Gyeonggi-do, 13496, Republic of Korea. Electronic address: wizard95@cha.ac.kr.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul 03760, Republic of Korea. Electronic address: orank@ewha.ac.kr.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2019.03.006']
687,31369675,Comparison of effects of cervical headgear treatment on skeletal facial changes when the treatment time is altered: a randomized controlled trial.,"BACKGROUND


There is a lack of evidence based on longitudinal information in the field of Class II malocclusion management with cervical headgear (CH), especially in a randomized setting.
OBJECTIVES


The main objective of this study was to evaluate skeletal facial changes, particularly in vertical dimensions, after Kloehn-type CH treatment in children when the timing of treatment is altered.
TRIAL DESIGN


Prospective, parallel-group, randomized controlled trial.
METHODS


Screened children with Class II malocclusion were randomized in 1:1 ratio to two groups of equal size by sealed-envelope randomization: the early group (EG), where active CH treatment was started at the age of 7.8 years, and the late group (LG), where CH treatment was started at the age of 9.5 years. The active treatment was continued until normal Class I occlusion on first molars was achieved. Cephalograms were taken at three different time points. Changes in cephalometric measurements were compared between groups and genders. Blinding was applicable for outcome evaluation.
RESULTS


Of 67 randomized children, 56 completed the study. Upper face height increased during the CH treatment phase, as the parameter N-ANS increased significantly during the active treatments of EG (P < 0.05) and LG (P < 0.05). Also, the parameter NSL-PL increased significantly during the treatment of EG (P < 0.01) and during the treatment of LG (P < 0.01). The Gonial angle decreased significantly in the early CH treatment group compared to the later treatment group (T0-T2: P < 0.01). CH improved the antero-posterior jaw relationship. No harms were encountered.
CONCLUSIONS


Although the upper face height increased, the mandible showed anterior rotation after CH treatment. The Gonial angle was significantly decreased in the EG compared to the LG. There were gender-specific differences in both sagittal and vertical dimensions when examining interrelations in dimensional changes. The differences found between the early and later treatment groups were not clinically important when the cephalometric results are considered.
CLINICAL REGISTRATION


ClinicalTrials.gov (NCT02010346).",2019,"Also, the parameter NSL-PL increased significantly during the treatment of EG (P < 0.01) and during the treatment of LG (P < 0.01).","['Class II malocclusion management with cervical headgear (CH', 'Screened children with Class II malocclusion', '67 randomized children']","['Kloehn-type CH', 'cervical headgear treatment', 'equal size by sealed-envelope randomization: the early group (EG), where active CH treatment']","['Upper face height', 'Gonial angle', 'skeletal facial changes', 'Changes in cephalometric measurements', 'parameter NSL-PL']","[{'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle Class II, Division 1'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C2963529', 'cui_str': 'Gonial angle (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",67.0,0.0332818,"Also, the parameter NSL-PL increased significantly during the treatment of EG (P < 0.01) and during the treatment of LG (P < 0.01).","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Julku', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Pirilä-Parkkinen', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}, {'ForeName': 'Mimmi', 'Initials': 'M', 'LastName': 'Tolvanen', 'Affiliation': 'Department of Community Dentistry, Institute of Dentistry, University of Turku, Finland.'}, {'ForeName': 'Pertti', 'Initials': 'P', 'LastName': 'Pirttiniemi', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}]",European journal of orthodontics,['10.1093/ejo/cjz053']
688,31436494,Evaluating the Acceptability and Feasibility of Providing Egg or Cereal Breakfast during a Family-Based Treatment for Children with Overweight/Obesity: The Families and Breakfast Pilot Trial.,"Background:  Family-based behavioral treatment (FBT) is the most successful weight-loss treatment for children with overweight and obesity, however, long-term success is only achieved by a third of children over time. The use of foods that induce satiety, such as eggs, could improve adherence to calorically restricted diets in children and improve outcomes. This study explored the consumption of eggs (FBT+egg) or cereal (FBT+cereal) for breakfast as part of an FBT program, when breakfast foods were provided to families.  Methods:  Fifty 8-12-year-old children with overweight and obesity and their parents were randomized to a 4-month FBT+egg or FBT+cereal treatment program. Families were provided the ingredients for their assigned breakfast at each treatment session, and instructed to consume the breakfast a minimum of 5 days per week. Families attended assessments at baseline, post-treatment, and 4-months post-treatment.  Results:  Results showed that both treatments were well liked, FBT attendance was similar, and there was high compliance with consumption of the specified breakfast. Children experienced moderate weight loss at post-treatment [-0.11 standardized BMI (BMIz)] through 4-month follow-up (-0.09 BMIz), with no statistically significant differences (mean difference -0.05 BMIz, 95% confidence interval -0.19 to 0.09) observed between egg and cereal conditions across any anthropometric or appetitive measures.  Conclusions:  The use of eggs for breakfast in children enrolled in FBT was well tolerated, and future studies should include larger samples and longer follow-up periods to assess the potential differential effects of prescribed breakfasts on children's weight and eating behaviors.",2019,"The use of foods that induce satiety, such as eggs, could improve adherence to calorically restricted diets in children and improve outcomes.","['children enrolled in', 'children with overweight and obesity', 'Fifty 8-12-year-old children with overweight and obesity and their parents', 'Children with Overweight/Obesity']","[':  Family-based behavioral treatment (FBT', 'FBT', 'Providing Egg or Cereal Breakfast', 'FBT+egg or FBT+cereal treatment program']","['moderate weight loss', 'well liked, FBT attendance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0007757', 'cui_str': 'Cereal Grain'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0596794,"The use of foods that induce satiety, such as eggs, could improve adherence to calorically restricted diets in children and improve outcomes.","[{'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Manzano', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Kyung E', 'Initials': 'KE', 'LastName': 'Rhee', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA.'}]",Childhood obesity (Print),['10.1089/chi.2018.0331']
689,31724083,"Açai pulp supplementation as a nutritional strategy to prevent oxidative damage, improve oxidative status, and modulate blood lactate of male cyclists.","PURPOSE


Açai pulp is a source of phytochemicals and has been associated with antioxidant, anti-inflammatory, and antigenotoxic effects. This study aimed to assess the effects of açai pulp consumption on oxidative, inflammatory, and aerobic capacity markers of cyclist athletes.
RESEARCH METHODS AND PROCEDURES


A crossover, randomized, placebo-controlled, single-blind study was developed with ten male cyclists (33.5 ± 4.7 years old, body mass index of 23.9 ± 1.38 kg/m 2 , and training load around 1875 ± 238 AU/week). The athletes consumed 400 g/day of pasteurized açai pulp (AP) or placebo (PL) for 15 days, with a 30-day wash-out period between trials. Lipid peroxidation, serum antioxidant capacity, DNA damage in peripheral blood (Comet assay), IL-6 and TNF-alpha, blood lactate concentration during effort, anaerobic threshold intensity (ATi), maximum workload reached (W max ), rating of perceived exertion threshold (RPET), and heart rate threshold (HRT) were evaluated before and after each intervention. Data were analyzed using a linear regression model with mixed effects (p ≤ 0.05).
RESULTS


Increased serum antioxidant capacity (p = 0.006) and decreased lipid peroxidation (p = 0.01) were observed in subjects after intervention with AP. Blood lactate levels during effort significantly decreased (by 29%, p = 0.025) and ATi increased (p = 0.006) after AP. No significant effect on DNA damage was attributed to AP consumption.
CONCLUSION


We found notable effects of AP intervention on antioxidant status in athletes. Both the reduction in blood lactate concentration and increase in ATi during the effort suggest an overall improvement in the aerobic capacity of the cyclists, confirming that AP consumption may influence variables associated with performance in endurance athletes.",2020,"Lipid peroxidation, serum antioxidant capacity, DNA damage in peripheral blood (Comet assay), IL-6 and TNF-alpha, blood lactate concentration during effort, anaerobic threshold intensity (ATi), maximum workload reached (W max ), rating of perceived exertion threshold (RPET), and heart rate threshold (HRT) were evaluated before and after each intervention.","['endurance athletes', 'cyclist athletes', 'ten male cyclists (33.5\u2009±\u20094.7\xa0years old, body mass index of 23.9\u2009±\u20091.38\xa0kg/m 2 , and training load around 1875\u2009±\u2009238 AU/week', 'male cyclists', 'athletes']","['placebo', 'açai pulp consumption', 'Açai pulp supplementation', 'AP intervention', 'pasteurized açai pulp (AP) or placebo (PL']","['antioxidant status', 'DNA damage', 'blood lactate concentration', 'Lipid peroxidation, serum antioxidant capacity, DNA damage in peripheral blood (Comet assay), IL-6 and TNF-alpha, blood lactate concentration during effort, anaerobic threshold intensity (ATi), maximum workload reached (W max ), rating of perceived exertion threshold (RPET), and heart rate threshold (HRT', 'Blood lactate levels', 'oxidative, inflammatory, and aerobic capacity markers', 'lipid peroxidation', 'serum antioxidant capacity']","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4517620', 'cui_str': '1875'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0012860', 'cui_str': 'DNA Injury'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0751980', 'cui_str': 'Gel Electrophoresis, Single-Cell'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.120809,"Lipid peroxidation, serum antioxidant capacity, DNA damage in peripheral blood (Comet assay), IL-6 and TNF-alpha, blood lactate concentration during effort, anaerobic threshold intensity (ATi), maximum workload reached (W max ), rating of perceived exertion threshold (RPET), and heart rate threshold (HRT) were evaluated before and after each intervention.","[{'ForeName': 'Sara Ivone Barros Morhy', 'Initials': 'SIBM', 'LastName': 'Terrazas', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, FCF UNESP, Rodovia Araraquara Jaú, km 01\xa0s/n, Araraquara, São Paulo, 14800-903, Brazil.'}, {'ForeName': 'Bryan Steve Martinez', 'Initials': 'BSM', 'LastName': 'Galan', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, FCF UNESP, Rodovia Araraquara Jaú, km 01\xa0s/n, Araraquara, São Paulo, 14800-903, Brazil.'}, {'ForeName': 'Flávia Giolo', 'Initials': 'FG', 'LastName': 'De Carvalho', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, EEFERP/USP, Avenida do Café s/n, Ribeirão Preto, São Paulo, 14040-903, Brazil.'}, {'ForeName': 'Vinicius Paula', 'Initials': 'VP', 'LastName': 'Venancio', 'Affiliation': 'School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, FCFRP/USP, Avenida do Café s/n, Ribeirão Preto, São Paulo, 14040-903, Brazil.'}, {'ForeName': 'Lusânia Maria Greggi', 'Initials': 'LMG', 'LastName': 'Antunes', 'Affiliation': 'School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, FCFRP/USP, Avenida do Café s/n, Ribeirão Preto, São Paulo, 14040-903, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Papoti', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, EEFERP/USP, Avenida do Café s/n, Ribeirão Preto, São Paulo, 14040-903, Brazil.'}, {'ForeName': 'Maricely Janette Uria', 'Initials': 'MJU', 'LastName': 'Toro', 'Affiliation': 'Center of Natural Sciences and Technology, State University of Pará, UEPA, Travessa Dr. Enéas Pinheiro, no 2626, Belém, Pará, 66095-015, Brazil.'}, {'ForeName': 'Iuri Ferreira', 'Initials': 'IF', 'LastName': 'da Costa', 'Affiliation': 'Center of Natural Sciences and Technology, State University of Pará, UEPA, Travessa Dr. Enéas Pinheiro, no 2626, Belém, Pará, 66095-015, Brazil.'}, {'ForeName': 'Ellen Cristini', 'Initials': 'EC', 'LastName': 'de Freitas', 'Affiliation': 'Department of Food and Nutrition. School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, FCF UNESP, Rodovia Araraquara Jaú, km 01\xa0s/n, Araraquara, São Paulo, 14800-903, Brazil. ellenfreitas@usp.br.'}]",European journal of nutrition,['10.1007/s00394-019-02138-7']
690,31539423,The effectiveness of repeating a social norm feedback intervention to high prescribers of antibiotics in general practice: a national regression discontinuity design.,"OBJECTIVES


Unnecessary antibiotic prescribing contributes to antimicrobial resistance. A randomized controlled trial in 2014-15 showed that a letter from England's Chief Medical Officer (CMO) to high-prescribing GPs, giving feedback about their prescribing relative to the norm, decreased antibiotic prescribing. The CMO sent further feedback letters in succeeding years. We evaluated the effectiveness of the repeated feedback intervention.
METHODS


Publicly available databases were used to identify GP practices whose antibiotic prescribing was in the top 20% nationally (the intervention group). In April 2017, GPs in every practice in the intervention group (n=1439) were sent a letter from the CMO. The letter stated that, 'the great majority of practices in England prescribe fewer antibiotics per head than yours'. Practices in the control group received no communication (n=5986). We used a regression discontinuity design to evaluate the intervention because assignment to the intervention condition was exogenous, depending on a 'rating variable'. The outcome measure was the average rate of antibiotic items dispensed from April 2017 to September 2017.
RESULTS


The GP practices who received the letter changed their prescribing rates by -3.69% (95% CI=-2.29 to -5.10; P<0.001), representing an estimated 124 952 fewer antibiotic items dispensed. The effect is robust to different specifications of the model.
CONCLUSIONS


Social norm feedback from a high-profile messenger continues to be effective when repeated. It can substantially reduce antibiotic prescribing at low cost and on a national scale. Therefore, it is a worthwhile addition to antimicrobial stewardship programmes.",2019,"The GP practices who received the letter changed their prescribing rates by -3.69% (95% CI=-2.29 to -5.10; P<0.001), representing an estimated 124 952 fewer antibiotic items dispensed.","['high prescribers of antibiotics in general practice', ""2014-15 showed that a letter from England's Chief Medical Officer (CMO) to high-prescribing GPs, giving feedback about their prescribing relative to the norm, decreased antibiotic prescribing""]",['social norm feedback intervention'],"['average rate of antibiotic items', 'prescribing rates']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0557516', 'cui_str': 'Medical officer (occupation)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]","[{'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}]",,0.0266698,"The GP practices who received the letter changed their prescribing rates by -3.69% (95% CI=-2.29 to -5.10; P<0.001), representing an estimated 124 952 fewer antibiotic items dispensed.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ratajczak', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gold', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hailstone', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England Behavioural Insights, Wellington House, 133-155 Waterloo Road, London, SE1 8UG, UK.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz392']
691,30962121,The effect of muscle fatigue on wrist joint position sense in healthy adults.,"STUDY DESIGN


Pretest and posttest experimental study.
INTRODUCTION


The effect of muscle fatigue on wrist joint position sense (JPS) has yet to be determined.
PURPOSE OF THE STUDY


The primary aim was to determine whether muscle fatigue affects wrist JPS in healthy adults. The secondary aims were to compare the effect of muscle fatigue on younger and older adults JPS and determine the association between JPS rate of change and total muscle fatigue (TMF) rates postexercise.
METHODS


Forty male and female healthy adults were assigned into younger (18-40 years) and older (41-65 years) groups. Preexercise and postexercise testing consisted of active wrist JPS, handgrip, and wrist extensor strength assessments. Muscle fatigue was induced via a calibrated gripper and wrist extension dumbbell exercises. Dependent variables were the JPS rate of change (ie, preexercise and postexercise), TMF rate (ie, grip and wrist extension average strength decline), and Borg Rating of Perceived Exertion scale scores.
RESULTS


Postexercise wrist JPS test scores were significantly higher than preexercise. Exercises induced statistically significant TMF rates and Borg Rating of Perceived Exertion scores among all participants. No statistically significant age-group differences on JPS rate of change, and TMF rate was found. A statistically significant mild correlation (r = 0.425) existed between JPS rate of change and TMF rates.
DISCUSSION


Postexercise fatigue significantly impairs wrist JPS in both younger and older adults. On average, an 18% muscle strength decline led to 215% wrist JPS deficit.
CONCLUSIONS


Significant wrist proprioception deficits persist for ≤5 min following exertional exercises, regardless of age level.",2020,Exercises induced statistically significant TMF rates and Borg Rating of Perceived Exertion scores among all participants.,"['younger and older adults', 'healthy adults', 'Forty male and female healthy adults were assigned into younger (18-40 years) and older (41-65 years) groups']","['wrist joint position sense (JPS', 'Preexercise and postexercise testing consisted of active wrist JPS, handgrip, and wrist extensor strength assessments']","['Muscle fatigue', 'TMF rates and Borg Rating of Perceived Exertion scores', 'Postexercise wrist JPS test scores', 'JPS rate of change and TMF rates', 'wrist joint position sense', 'JPS rate of change, and TMF rate', 'JPS rate of change (ie, preexercise and postexercise), TMF rate (ie, grip and wrist extension average strength decline), and Borg Rating of Perceived Exertion scale scores']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1322271', 'cui_str': 'Wrist joint structure (body structure)'}, {'cui': 'C0234219', 'cui_str': 'Position Sense'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0242979', 'cui_str': 'Muscular Fatigue'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1322271', 'cui_str': 'Wrist joint structure (body structure)'}, {'cui': 'C0234219', 'cui_str': 'Position Sense'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0222045'}]",40.0,0.0706804,Exercises induced statistically significant TMF rates and Borg Rating of Perceived Exertion scores among all participants.,"[{'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Karagiannopoulos', 'Affiliation': 'DeSales University, Doctor of Physical Therapy Program, Center Valley, PA, USA. Electronic address: karagiannopoulosc@gmail.com.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'DeSales University, Doctor of Physical Therapy Program, Center Valley, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kahan', 'Affiliation': 'DeSales University, Doctor of Physical Therapy Program, Center Valley, PA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Lawler', 'Affiliation': 'DeSales University, Doctor of Physical Therapy Program, Center Valley, PA, USA.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.03.004']
692,31853609,Randomized Trial of Deep Vein Thrombosis Chemoprophylaxis with Bemiparin and Enoxaparin in Patients with Moderate to High Thrombogenic Risk Undergoing Plastic and Reconstructive Surgery Procedures.,"BACKGROUND


Deep vein thrombosis (DVT) is a common complication during postoperative convalescence characterized by hypercoagulability, vascular endothelium damage and blood stasis. It increases noticeably in peri/postoperative phases of surgery procedures. Pulmonary embolism secondary to iliofemoral DVT is a frequent cause of death.
METHODS


Adult patients scheduled for plastic and reconstructive surgery (PRSx) with moderate to high thrombogenic risk were selected. We evaluated the efficacy and safety of bemiparin compared to enoxaparin as chemoprophylaxis for DVT. Following balanced general anesthesia techniques, patients were randomly assigned for subcutaneous enoxaparin 40 IU (Group-E) or bemiparin 3500 IU (Group-B) q24h starting 6 h after procedure conclusion for at least 10 days. All patients were evaluated for DVT through Doppler ultrasound mapping of the lower limbs.
RESULTS


Seventy-eight patients were evaluated, mostly women (83%), physical status ASA II (59%), ASA III (10%); Caprini's thrombogenic risk score 3-4 (moderate) 58%, 5-6 (high) 29%, > 6 (too high) 13%; demographics, clinical variables and scores were similar between groups. Median drainage time in breast surgery was 4 days in both groups (p = 0.238). In the case of abdominal surgery, median was 14 days in Group-E versus 13 days in Group-B (p = 0.059). No DVT was detected in either group.
CONCLUSIONS


DVT was prevented with bemiparin, without significant bleeding increase nor adverse events; moreover, the cost of bemiparin is lower than enoxaparin. Bemiparin can be considered as alternative drug for DVT chemoprophylaxis in PRSx procedures.
LEVEL OF EVIDENCE III


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2020,Median drainage time in breast surgery was 4 days in both groups (p = 0.238).,"['Adult patients scheduled for plastic and reconstructive surgery (PRSx) with moderate to high thrombogenic risk were selected', 'Patients with Moderate to High Thrombogenic Risk Undergoing Plastic and Reconstructive Surgery Procedures']","['enoxaparin', 'bemiparin', 'Deep Vein Thrombosis Chemoprophylaxis with Bemiparin and Enoxaparin', 'subcutaneous enoxaparin 40\xa0IU (Group-E) or bemiparin 3500\xa0IU']","['Median drainage time', ""Caprini's thrombogenic risk score"", 'efficacy and safety', 'physical status ASA', 'DVT', 'adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0916062', 'cui_str': 'bemiparin'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0441839', 'cui_str': 'Group E (qualifier value)'}, {'cui': 'C4517736', 'cui_str': '3500'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",78.0,0.068905,Median drainage time in breast surgery was 4 days in both groups (p = 0.238).,"[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Revilla-Peñaloza', 'Affiliation': 'Anesthesiology Service, American British Cowdray Santa Fe Medical Center, No. 154 Carlos Graef Fernandez Av., Santa Fe, Del. Cuajimalpa, 053333, Mexico City, Mexico.'}, {'ForeName': 'Paul Jay', 'Initials': 'PJ', 'LastName': 'Olsoff-Pagovich', 'Affiliation': 'Plastic and Reconstructive Surgery, ABC Santa Fe Medical Center, No. 154 Carlos Graef Fernandez Av., Santa Fe, Cuajimalpa, 053333, Mexico City, Mexico.'}, {'ForeName': 'Jose Ramon', 'Initials': 'JR', 'LastName': 'Ochoa-Gomez', 'Affiliation': 'Plastic and Reconstructive Surgery, ABC Santa Fe Medical Center, No. 154 Carlos Graef Fernandez Av., Santa Fe, Cuajimalpa, 053333, Mexico City, Mexico.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Castaneda-Gaxiola', 'Affiliation': 'Angiology and Vascular Surgery, ABC Santa Fe Medical Center, No. 154 Carlos Graef Fernandez Av., Santa Fe, Cuajimalpa, 053333, Mexico City, Mexico.'}, {'ForeName': 'Ángel Iván', 'Initials': 'ÁI', 'LastName': 'Rubio-Gayosso', 'Affiliation': 'Sección de Estudios de posgrado, Escuela Superior de Medicina, Instituto Politécnico Nacional, Plan de San Luis y Díaz Mirón, CP 11340, Mexico City, Mexico.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Ceballos', 'Affiliation': 'Sección de Estudios de posgrado, Escuela Superior de Medicina, Instituto Politécnico Nacional, Plan de San Luis y Díaz Mirón, CP 11340, Mexico City, Mexico.'}, {'ForeName': 'Juan Arcadio', 'Initials': 'JA', 'LastName': 'Molina-Guarneros', 'Affiliation': 'Pharmacology Department, Faculty of Medicine, National Autonomous University of Mexico, Av. Universidad No. 3000, Colonia Ciudad Universitaria, CP 04510, Alcaldía Coyoacan, Mexico City, Mexico. jamg@unam.mx.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01573-5']
693,28560305,"Hydrocortisone 1% cream and sertaconazole 2% cream to treat facial seborrheic dermatitis: A double-blind, randomized clinical trial.","BACKGROUND


Seborrheic dermatitis (SD) is a chronic dermatitis with periods of remission and relapse that requires long-term treatment.
OBJECTIVE


We compared the efficacy and safety of treatment with sertaconazole with standard corticosteroid medications in adults with facial SD.
METHODS


In this double-blind, randomized controlled trial, 60 patients with a diagnosis of SD were enrolled. Patients were instructed to apply either sertaconazole 2% cream (30 patients) or hydrocortisone 1% cream (30 patients) twice daily to the affected area of the face. The severity of facial SD was assessed at 0, 2, and 4 weeks of treatment. Secondary efficacy measures included patient assessment of seborrhea, adverse events, and improvement percentage (IP).
RESULTS


SD lesions cleared significantly ( p  < .05) and similarly in both treatment groups ( p  > .05). Both treatments resulted in significant improvement of SD lesions and the rate of adverse events was similar in both groups. The IP was higher for treatment with hydrocortisone in Week 2 and similar in both groups at the end of the study.
LIMITATIONS


Limitations include the small number of patients who were recruited for this study and the lack of evaluation of time to relapse.
CONCLUSION


Treatment with topical sertaconazole may be regarded as a substitute for topical corticosteroid medications due to the fewer adverse events and similar efficacy.",2017,"RESULTS


SD lesions cleared significantly ( p  < .05) and similarly in both treatment groups ( p  > .05).","['60 patients with a diagnosis of SD were enrolled', 'adults with facial SD', 'facial seborrheic dermatitis']","['sertaconazole 2% cream', 'hydrocortisone 1% cream', 'sertaconazole with standard corticosteroid medications', 'hydrocortisone', 'Hydrocortisone 1% cream and sertaconazole 2% cream']","['patient assessment of seborrhea, adverse events, and improvement percentage (IP', 'rate of adverse events', 'SD lesions', 'efficacy and safety', 'severity of facial SD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1275433', 'cui_str': 'Facial seborrheic eczema'}]","[{'cui': 'C0074391', 'cui_str': 'sertaconazole'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036508', 'cui_str': 'Seborrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",60.0,0.400234,"RESULTS


SD lesions cleared significantly ( p  < .05) and similarly in both treatment groups ( p  > .05).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Balighi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S Z', 'Initials': 'SZ', 'LastName': 'Ghodsi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Daneshpazhooh', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ghale-Baghi', 'Affiliation': 'Research Center and Department of Head and Neck Surgery, Hazrat-e-Rasool Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nasimi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Azizpour', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of women's dermatology,['10.1016/j.ijwd.2016.11.008']
694,31718423,A causal modelling framework for reference-based imputation and tipping point analysis in clinical trials with quantitative outcome.,"We consider estimation in a randomised placebo-controlled or standard-of-care-controlled drug trial with quantitative outcome, where participants who discontinue an investigational treatment are not followed up thereafter, and the estimand follows a treatment policy strategy for handling treatment discontinuation. Our approach is also useful in situations where participants take rescue medication or a subsequent line of therapy and the estimand follows a hypothetical strategy to estimate the effect of initially randomised treatment in the absence of rescue or other active treatment. Carpenter et al proposed reference-based imputation methods which use a reference arm to inform the distribution of post-discontinuation outcomes and hence to inform an imputation model. However, the reference-based imputation methods were not formally justified. We present a causal model which makes an explicit assumption in a potential outcomes framework about the maintained causal effect of treatment after discontinuation. We use mathematical argument and a simulation study to show that the ""jump to reference"", ""copy reference"" and ""copy increments in reference"" reference-based imputation methods, with the control arm as the reference arm, are special cases of the causal model with specific assumptions about the causal treatment effect. We also show that the causal model provides a flexible and transparent framework for a tipping point sensitivity analysis in which we vary the assumptions made about the causal effect of discontinued treatment. We illustrate the approach with data from two longitudinal clinical trials.",2020,"We use mathematical argument and a simulation study to show that the ""jump to reference"", ""copy reference"" and ""copy increments in reference"" reference-based imputation methods, with the control arm as the reference arm, are special cases of the causal model with specific assumptions about the causal treatment effect.","['participants who discontinue an investigational treatment are not followed up thereafter, and the estimand follows a treatment policy strategy for handling treatment discontinuation']",['placebo'],[],"[{'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0949266', 'cui_str': 'Investigational Treatments'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0018578', 'cui_str': 'Handling'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.07831,"We use mathematical argument and a simulation study to show that the ""jump to reference"", ""copy reference"" and ""copy increments in reference"" reference-based imputation methods, with the control arm as the reference arm, are special cases of the causal model with specific assumptions about the causal treatment effect.","[{'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'White', 'Affiliation': 'MRC Biostatistics Unit, Cambridge, UK.'}, {'ForeName': 'Royes', 'Initials': 'R', 'LastName': 'Joseph', 'Affiliation': 'MRC Biostatistics Unit, Cambridge, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Best', 'Affiliation': 'R&D Biostatistics, GlaxoSmithKline, Uxbridge, UK.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2019.1684308']
695,31554878,Concomitant screening of coronary artery disease and lung cancer with a new ultrafast-low-dose Computed Tomography protocol: A pilot randomised trial.,"We performed a pilot randomised study to assess the feasibility and radiation exposure of a new computed tomography (CT) protocol that allows screening of both coronary artery disease (CAD) and lung cancer. Current or former heavy smokers at high lung cancer risk with indication to cardiac CT for suspected or known CAD were randomised to undergo concomitant CT evaluation of either cardiac or thoracic area or cardiac CT only. Out of 129 subjects deemed eligible for the study, 110 agreed to participate and were randomised to simultaneous cardiac and lung CT (Gr.A; n = 55) or cardiac CT only (Gr.B; n = 55). The feasibility (i.e. adequate visualization of coronary artery segments) was noninferior with simultaneous cardiac and lung CT compared with the standard cardiac CT (870 of 889 segments [97%] in Gr.A vs 878/890 segments [99%] in Gr.B; mean difference 2.0% [90% confidence interval: -0.3% to 4.1%]). The safety (i.e. effective radiation dose) of the concomitant cardiac and lung CT protocol was noninferior to the standard cardiac CT (1.5 [95% confidence intervals: 1.2-1.7] vs. 1.4 [95% confidence intervals: 1.1-1.6] mSv; mean difference 0.1 mSv [90% confidence interval: -0.2 to 0.3 mSv]). In the two groups, a total of 25 significant (>70%) coronary stenoses were found at cardiac CT (9/55 cases of Gr.A vs 11/55 cases of Gr.B). Pulmonary nodules >2 mm were detected in 7 of the 55 Gr.A subjects. This pilot randomised study shows that concomitant CAD and lung cancer screening by means of a new CT protocol is both feasible and safe, thus allowing a comprehensive evaluation of both cardiac and thoracic regions during one CT scanning only. (ClinicalTrials.gov Identifier: NCT03727958).",2019,The safety (i.e. effective radiation dose) of the concomitant cardiac and lung CT protocol was noninferior to the standard cardiac CT (1.5 [95% confidence intervals: 1.2-1.7] vs. 1.4 [95% confidence intervals: 1.1-1.6] mSv; mean difference 0.1 mSv,"['129 subjects deemed eligible for the study, 110 agreed to participate and were randomised to simultaneous cardiac and lung CT (Gr', 'heavy smokers at high lung cancer risk with indication to cardiac CT for suspected or known CAD', 'coronary artery disease (CAD) and lung cancer']","['new ultrafast-low-dose Computed Tomography protocol', 'cardiac CT', 'standard cardiac CT', 'new computed tomography (CT) protocol', 'new CT protocol']",[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0412618', 'cui_str': 'Cardiac CT'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0412618', 'cui_str': 'Cardiac CT'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0056574', 'cui_str': 'CT protocol'}]",[],889.0,0.0646978,The safety (i.e. effective radiation dose) of the concomitant cardiac and lung CT protocol was noninferior to the standard cardiac CT (1.5 [95% confidence intervals: 1.2-1.7] vs. 1.4 [95% confidence intervals: 1.1-1.6] mSv; mean difference 0.1 mSv,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Gaudio', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tanzilli', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Mariachiara', 'Initials': 'M', 'LastName': 'Mei', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moretti', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Barillà', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Varveri', 'Affiliation': 'Villa Mafalda Clinical Institute, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Paravati', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Tanzilli', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ciccaglioni', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Strano', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Pellegrini', 'Affiliation': 'Villa Mafalda Clinical Institute, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Barillari', 'Affiliation': 'Villa Mafalda Clinical Institute, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pelliccia', 'Affiliation': 'Department of Cardiovascular Sciences, Sapienza University, Rome, Italy. f.pelliccia@mclink.it.'}]",Scientific reports,['10.1038/s41598-019-50407-6']
696,31005431,Comparison of Anterior-Stabilized and Posterior-Stabilized Total Knee Arthroplasty in the Same Patients: A Prospective Randomized Study.,"BACKGROUND


A highly conforming, anterior-stabilized (AS) insert is designed to provide anteroposterior (AP) stability of the posterior-stabilized (PS) insert without a post. The purpose of this study was to compare the static and dynamic stability and function of AS and PS total knee arthroplasty (TKA) in the same patients.
METHODS


A prospective, randomized controlled trial was performed in 45 patients scheduled to undergo same-day bilateral TKA. One knee was randomly assigned to receive an AS TKA, and the other knee was scheduled for a PS TKA from the same knee system. At 2 years postoperatively, the static AP stability was compared using anterior and posterior drawer stress radiographs at 90° knee flexion. Dynamic AP stability was evaluated using one-leg standing lateral fluoroscopic images throughout the range of motion. Knee function was compared using the Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index score.
RESULTS


At 2 years postoperatively, there was a significant difference in knee AP laxity at 90° of flexion between the two groups (7.6 ± 3.9 mm in the AS group vs 2.2 ± 2.3 in the PS group, P < .001). However, there were no differences in dynamic AP stability under one-leg standing fluoroscopic lateral images at 30°, 60°, and 90° knee flexion (P = .732, P = .764, and P = .679, respectively). The Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index scores were not significantly different between the two groups (P = .641 and P = .582, respectively).
CONCLUSION


Despite the fact that the AS TKA group showed significantly more static posterior displacement than the PS TKA group at 90° of knee flexion, both the AS and PS TKA groups showed similar dynamic stability under weight-bearing conditions and knee function at 2 years postoperatively.",2019,"The Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index scores were not significantly different between the two groups (P = .641 and P = .582, respectively).
","['Same Patients', 'same patients', '45 patients scheduled to undergo same-day bilateral TKA']","['Anterior-Stabilized and Posterior-Stabilized Total Knee Arthroplasty', 'AS TKA', 'PS TKA']","['Knee function', 'Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index score', 'dynamic stability under weight-bearing conditions and knee function', 'knee AP laxity', 'dynamic AP stability under one-leg standing fluoroscopic lateral images', 'static posterior displacement', 'Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index scores', 'static and dynamic stability and function of AS and PS total knee arthroplasty (TKA', 'static AP stability', 'Dynamic AP stability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0333044', 'cui_str': 'Posterior displacement (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]",45.0,0.0336349,"The Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index scores were not significantly different between the two groups (P = .641 and P = .582, respectively).
","[{'ForeName': 'Sung W', 'Initials': 'SW', 'LastName': 'Jang', 'Affiliation': 'Department of Orthopaedic Surgery, Chakhan Madi Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Man S', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'In J', 'Initials': 'IJ', 'LastName': 'Koh', 'Affiliation': ""Department of Orthopaedic Surgery, St. Paul's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Sueen', 'Initials': 'S', 'LastName': 'Sohn', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Chulkyu', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'In', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",The Journal of arthroplasty,['10.1016/j.arth.2019.03.062']
697,31718998,Detection of optical coherence tomography-defined thin-cap fibroatheroma in the coronary artery using deep learning.,"AIMS


The aim of this study was to develop a deep learning model for classifying frames with versus without optical coherence tomography (OCT)-derived thin-cap fibroatheroma (TCFA).
METHODS AND RESULTS


A total of 602 coronary lesions from 602 angina patients were randomised into training and test sets in a 4:1 ratio. A DenseNet model was developed to classify OCT frames with or without OCT-derived TCFA. Gradient-weighted class activation mapping was used to visualise the area of attention. In the training sample (35,678 frames of 480 lesions), the model with fivefold cross-validation had an overall accuracy of 91.6±1.7%, sensitivity of 88.7±3.4%, and specificity of 91.8±2.0% (averaged AUC=0.96±0.01) in predicting the presence of TCFA. In the test samples (9,722 frames of 122 lesions), the overall accuracy at the frame level was 92.8% within the lesion (AUC=0.96) and 91.3% in the entire OCT pullback. The correlation between the %TCFA burden per vessel predicted by the model compared with that identified by experts was significant (r=0.87, p<0.001). The region of attention was localised at the site of the thin cap in 93.4% of TCFA-containing frames. Total computational time per pullback was 2.1±0.3 seconds.
CONCLUSIONS


A deep learning algorithm can accurately detect an OCT-TCFA with high reproducibility. The time-saving computerised process may assist clinicians to recognise high-risk lesions easily and to make decisions in the catheterisation laboratory.",2020,"In the test samples (9,722 frames of 122 lesions), the overall accuracy at the frame level was 92.8% within the lesion (AUC=0.96) and 91.3% in the entire OCT pullback.",['Total 602 coronary lesions from 602 angina patients'],"['Optical Coherence Tomography-Defined Thin-Cap Fibroatheroma', 'optical coherence tomography (OCT)-derived thin-cap fibroatheroma (TCFA']","['Total computational time per a pullback', 'overall accuracy at the frame level']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C2936351', 'cui_str': 'Fibroatheromatous Plaques'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",602.0,0.0357016,"In the test samples (9,722 frames of 122 lesions), the overall accuracy at the frame level was 92.8% within the lesion (AUC=0.96) and 91.3% in the entire OCT pullback.","[{'ForeName': 'Hyun-Seok', 'Initials': 'HS', 'LastName': 'Min', 'Affiliation': 'Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Ji Hyeong', 'Initials': 'JH', 'LastName': 'Yoo', 'Affiliation': ''}, {'ForeName': 'Soo-Jin', 'Initials': 'SJ', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'June-Goo', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Hyungjoo', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Seung-Whan', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Young-Hak', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Cheol Whan', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Seong-Wook', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00487']
698,31016503,"Growth Trajectories of Peer Norms, Self-efficacy and Condom Use Behavior Among Sexually Active Chinese Men Who Have Sex with Men: Latent Class Analysis and Growth Mixture Modeling.","Data from a randomized controlled trial in 2015 were used to estimate the growth trajectories of peer norms, self-efficacy, and condom use behavior, and to identify associated sociodemographic and behavioral factors among a sample of 804 Chinese men who have sex with men (MSM). Latent class analysis and growth mixture modeling were conducted using Mplus. Two growth trajectories were estimated for each outcome variable with good model fit. The growth trajectories of peer norms were related to age (β = - 0.066, p < 0.05). The growth trajectories of self-efficacy were related to age (β = 0.057, p < 0.01) and using a condom during first sexual encounter with another man (β = 0.777, p < 0.001). The growth trajectories of condom use behavior were related to income (β = 0.366, p < 0.01) and having casual male partners (β = - 1.016, p < 0.001). Predictors for the growth factors within each latent class were also estimated. For subsets of MSM who are older, richer, used a condom during their first sexual encounter with another man, and do not have a casual male partner, condom videos may not have sufficient efficacy and other interventions may be necessary.",2020,"The growth trajectories of condom use behavior were related to income (β = 0.366, p < 0.01) and having casual male partners (β = - 1.016, p < 0.001).","['Sexually Active Chinese Men', '804 Chinese men who have sex with men (MSM', 'Who Have Sex with Men']",[],"['growth trajectories of peer norms', 'growth trajectories of condom use behavior', 'growth trajectories of self-efficacy', 'Growth Trajectories of Peer Norms, Self-efficacy and Condom Use Behavior']","[{'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",[],"[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",804.0,0.0225849,"The growth trajectories of condom use behavior were related to income (β = 0.366, p < 0.01) and having casual male partners (β = - 1.016, p < 0.001).","[{'ForeName': 'Haochu', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shandong University, 44 West Wenhua Road, Jinan, 250012, Shandong, China. haochuli@yahoo.com.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'UNC Project-China, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shandong University, 44 West Wenhua Road, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Department of Educational and Psychological Studies, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Gifty', 'Initials': 'G', 'LastName': 'Marley', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dianmin', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Shandong Provincial Center for Disease Control and Prevention, Jinan, China.'}, {'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Liao', 'Affiliation': 'Shandong Provincial Center for Disease Control and Prevention, Jinan, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'UNC Project-China, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Baofa', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shandong University, 44 West Wenhua Road, Jinan, 250012, Shandong, China.'}]",AIDS and behavior,['10.1007/s10461-019-02515-7']
699,31009433,Changes in Bench Press Velocity and Power After 8 Weeks of High-Load Cluster- or Traditional-Set Structures.,"Davies, TB, Halaki, M, Orr, R, Helms, ER, and Hackett, DA. Changes in bench press velocity and power after 8 weeks of high-load cluster- or traditional-set structures. J Strength Cond Res 34(10): 2734-2742, 2020-This study investigated the effects of high-load cluster- vs. traditional-set structures using the bench press on velocity and power. Twenty-one resistance-trained individuals (male = 12, female = 9) performed a 3-week familiarization block followed by randomization into 1 of 2 upper- and lower-body split training routines performed for 8 weeks. The bench press was the only exercise manipulated with subjects using either cluster-set (CLUS, n = 11) or traditional-set (TRAD, n = 10) structures during training sessions. Subjects performed 4 sets of 5 repetitions at 85% 1 repetition maximum (1RM) with CLUS having a 30-second inter-repetition, and 3-minute interset rest while TRAD had a 5-minute interset rest. A load-velocity profile of relative loads derived from a 1RM test was used to assess velocity and power (absolute and relative to body mass) on the bench press. Significant improvements over time were found across various loads ranging from 45 to 75% 1RM for absolute and relative peak power (p = 0.006-0.041), and mean power (p = 0.001-0.032). Significant decreases over time were found at 55% 1RM and 65% 1RM for peak velocity (p = 0.027 and p = 0.012, respectively) and mean velocity (p = 0.047 and p = 0.022, respectively). There were no significant group or group by time interactions found for all outcomes. Within the context of high-load resistance training, set structure seems to be of less importance for changes in bench press velocity and power provided there is an intention to lift with maximal concentric velocity.",2020,"Significant improvements over time were found across various loads ranging from 45 to 75% 1RM for absolute and relative peak power (p = 0.006-0.041), and mean power (p = 0.001-0.032).","['Twenty-one resistance-trained individuals (male = 12, female = 9']",['J Strength Cond Res XX(X'],"['Davies, TB, Halaki, M, Orr, R, Helms, ER, and Hackett, DA', 'mean velocity', 'peak velocity', 'velocity and power (absolute and relative to body mass']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.020896,"Significant improvements over time were found across various loads ranging from 45 to 75% 1RM for absolute and relative peak power (p = 0.006-0.041), and mean power (p = 0.001-0.032).","[{'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Davies', 'Affiliation': 'Discipline of Exercise and Sports Science, Faculty of Health Science, University of Sydney, Lidcombe, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Halaki', 'Affiliation': 'Discipline of Exercise and Sports Science, Faculty of Health Science, University of Sydney, Lidcombe, New South Wales, Australia.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Orr', 'Affiliation': 'Discipline of Exercise and Sports Science, Faculty of Health Science, University of Sydney, Lidcombe, New South Wales, Australia.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Helms', 'Affiliation': 'School of Sport and Recreation, Sport Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Hackett', 'Affiliation': 'Discipline of Exercise and Sports Science, Faculty of Health Science, University of Sydney, Lidcombe, New South Wales, Australia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003166']
700,30253043,Relationship between three commonly used non-invasive fibrosis biomarkers and improvement in fibrosis stage in patients with non-alcoholic steatohepatitis.,"BACKGROUND & AIMS


Non-invasive biomarkers are needed for monitoring changes in liver histology in patients with non-alcoholic steatohepatitis (NASH). Obeticholic acid (OCA) was shown to improve fibrosis in patients with NASH in the FLINT trial; a post hoc analysis of these data was performed to determine the relationship between 3 non-invasive fibrosis markers and liver fibrosis improvement.
METHODS


In the Phase 2b FLINT trial, patients were randomised (1:1) to receive 25 mg OCA or placebo once daily for 72 weeks. Aspartate aminotransferase:platelet ratio index (APRI), fibrosis-4 (FIB-4) index and non-alcoholic fatty liver disease fibrosis score (NFS) were evaluated in serum at baseline and weeks 24, 48, 72 and 96. Liver biopsies were obtained at baseline and 72 weeks.
RESULTS


In patients with fibrosis improvement at week 24, scores were reduced by a median of 34% for APRI, 10% for FIB-4 and 4% for NFS. Reductions in APRI (P = 0.015) and FIB-4 (P = 0.036), but not NFS (P = 0.201) at week 24, significantly correlated with ≥1-stage improvement in histologic fibrosis at week 72. Reductions in APRI at week 72 were significantly correlated with fibrosis improvement at week 72 (P = 0.012). Patients receiving OCA had significant reductions in all markers compared with patients receiving placebo at week 72 [APRI and FIB-4 (P < 0.0001); NFS (P < 0.05)].
CONCLUSIONS


Readily available non-invasive markers may predict improvement in liver fibrosis in patients with NASH. Upon external confirmation and further refinement in larger populations, these markers may serve as surrogate endpoints in NASH clinical trials.",2019,"Patients receiving OCA had significant reductions in all markers compared with patients receiving placebo at week 72 [APRI and FIB-4 (P < 0.0001); NFS (P < 0.05)].
","['patients with non-alcoholic steatohepatitis (NASH', 'patients with NASH', 'patients with non-alcoholic steatohepatitis']","['OCA or placebo', 'Obeticholic acid (OCA', 'placebo', 'OCA']","['Liver biopsies', 'histologic fibrosis', 'FIB-4', 'fibrosis stage', 'fibrosis improvement', 'Reductions in APRI', 'liver fibrosis', 'Aspartate aminotransferase:platelet ratio index (APRI), fibrosis-4 (FIB-4) index and non-alcoholic fatty liver disease fibrosis score (NFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1143018', 'cui_str': 'obeticholic acid'}]","[{'cui': 'C0193388', 'cui_str': 'Biopsy of liver (procedure)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.337244,"Patients receiving OCA had significant reductions in all markers compared with patients receiving placebo at week 72 [APRI and FIB-4 (P < 0.0001); NFS (P < 0.05)].
","[{'ForeName': 'Naga', 'Initials': 'N', 'LastName': 'Chalasani', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Manal F', 'Initials': 'MF', 'LastName': 'Abdelmalek', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Organ Transplant Center, Swedish Medical Center, Seattle, Washington.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Dasarathy', 'Affiliation': 'Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Neuschwander-Tetri', 'Affiliation': 'Department of Internal Medicine, Saint Louis University, Saint Louis, Missouri.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Terrault', 'Affiliation': 'Departments of Medicine and Surgery, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Ferguson', 'Affiliation': 'Intercept Pharmaceuticals, Inc, San Diego, California.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Shringarpure', 'Affiliation': 'Intercept Pharmaceuticals, Inc, San Diego, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shapiro', 'Affiliation': 'Intercept Pharmaceuticals, Inc, San Diego, California.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.13974']
701,30980514,Efficacy and Safety of Intravenous Golimumab Through One Year in Patients With Active Psoriatic Arthritis.,"OBJECTIVE


The present study was undertaken to evaluate the safety and efficacy of intravenous (IV) golimumab in patients with active psoriatic arthritis (PsA) through 1 year.
METHODS


GO-VIBRANT was a phase III, randomized, placebo-controlled trial of 480 adults with active PsA. Patients were randomized to receive IV placebo (n = 239) or golimumab 2 mg/kg (n = 241) at weeks 0, 4, and every 8 weeks, with placebo crossover to golimumab at weeks 24, 28, and every 8 weeks thereafter. Efficacy through week 52 was assessed using the American College of Rheumatology (ACR) ≥20%, 50%, or 70% improvement criteria (ACR20/50/70), and the Psoriasis Area and Severity Index ≥75% improvement criteria (PASI75). Radiographic progression was measured using the PsA-modified Sharp/van der Heijde score (SHS). Adverse events (AEs) were monitored through week 60.
RESULTS


The primary and major secondary end points through week 24 were achieved. At week 52, 76.8% of patients in the golimumab group and 77.0% in the placebo-crossover group achieved an ACR20 response, 58.1% and 53.6%, respectively, achieved an ACR50 response, and 38.6% and 33.9%, respectively, achieved an ACR70 response. Among patients with ≥3% body surface area affected, 71.9% in the golimumab group and 60.6% in the placebo-crossover group achieved a PASI75 response at week 52. Mean change from baseline in total SHS at week 52 was -0.5 in the golimumab group and 0.8 in the placebo-crossover group. Through week 60, 50.9% of all golimumab-treated patients had ≥1 AE, and 5.2% had ≥1 serious AE. There were no opportunistic infections, 2 malignancies, and 1 death in patients treated with golimumab.
CONCLUSION


Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study. No new safety signals for IV golimumab were identified.",2020,"CONCLUSION


Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study.","['Patients with Active Psoriatic Arthritis', 'patients with active psoriatic arthritis (PsA) through 1 year', '480 adults with active PsA. Patients', 'patients with PsA']","['intravenous golimumab', 'Intravenous Golimumab', 'placebo', 'intravenous placebo', 'placebo crossover to golimumab', 'golimumab']","['ACR70 response', 'Psoriasis Area and Severity Index (PASI75); radiographic progression', 'ACR criteria (ACR20/50/70), Health Assessment Questionnaire-Disability Index (HAQ-DI', 'ACR50 response', 'PASI75 response', 'total vdH-S score', 'Efficacy and Safety', 'Adverse events (AEs', 'joint and skin disease', 'ACR20 response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0037274', 'cui_str': 'Dermatoses'}]",480.0,0.512219,"CONCLUSION


Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study.","[{'ForeName': 'M Elaine', 'Initials': 'ME', 'LastName': 'Husni', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California San Diego, La Jolla.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Murphy', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Rekalov', 'Affiliation': 'Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Harrison', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Jocelyn H', 'Initials': 'JH', 'LastName': 'Leu', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania, and University of Pennsylvania, Philadelphia.'}]",Arthritis care & research,['10.1002/acr.23905']
702,30449712,Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial.,"BACKGROUND


Post-traumatic stress disorder (PTSD) is a complex and difficult-to-treat disorder, affecting 10-20% of military veterans. Previous research has raised the question of whether a non-trauma-focused treatment can be as effective as trauma exposure therapy in reducing PTSD symptoms. This study aimed to compare the non-trauma-focused practice of Transcendental Meditation (TM) with prolonged exposure therapy (PE) in a non-inferiority clinical trial, and to compare both therapies with a control of PTSD health education (HE).
METHODS


We did a randomised controlled trial at the Department of Veterans Affairs San Diego Healthcare System in CA, USA. We included 203 veterans with a current diagnosis of PTSD resulting from active military service randomly assigned to a TM or PE group, or an active control group of HE, using stratified block randomisation. Each treatment provided 12 sessions over 12 weeks, with daily home practice. TM and HE were mainly given in a group setting and PE was given individually. The primary outcome was change in PTSD symptom severity over 3 months, assessed by the Clinician-Administered PTSD Scale (CAPS). Analysis was by intention to treat. We hypothesised that TM would show non-inferiority to PE in improvement of CAPS score (Δ=10), with TM and PE superior to PTSD HE. This study is registered with ClinicalTrials.gov, number NCT01865123.
FINDINGS


Between June 10, 2013, and Oct 7, 2016, 203 veterans were randomly assigned to an intervention group (68 to the TM group, 68 to the PE group, and 67 to the PTSD HE group). TM was significantly non-inferior to PE on change in CAPS score from baseline to 3-month post-test (difference between groups in mean change -5·9, 95% CI -14·3 to 2·4, p=0·0002). In standard superiority comparisons, significant reductions in CAPS scores were found for TM versus PTSD HE (-14·6 95% CI, -23·3 to -5·9, p=0·0009), and PE versus PTSD HE (-8·7 95% CI, -17·0 to -0·32, p=0·041). 61% of those receiving TM, 42% of those receiving PE, and 32% of those receiving HE showed clinically significant improvements on the CAPS score.
INTERPRETATION


A non-trauma-focused-therapy, TM, might be a viable option for decreasing the severity of PTSD symptoms in veterans and represents an efficacious alternative for veterans who prefer not to receive or who do not respond to traditional exposure-based treatments of PTSD.
FUNDING


Department of Defense, US Army Medical Research.",2018,"TM was significantly non-inferior to PE on change in CAPS score from baseline to 3-month post-test (difference between groups in mean change -5·9,","['203 veterans with a current diagnosis of PTSD resulting from active military service randomly assigned to a', 'Between June 10, 2013, and Oct 7, 2016, 203 veterans', 'Department of Veterans Affairs San Diego Healthcare System in CA, USA', 'veterans with post-traumatic stress disorder', 'veterans who prefer not to receive or who do not respond to traditional exposure-based treatments of PTSD']","['TM', 'TM or PE group, or an active control group of HE', 'Transcendental Meditation (TM) with prolonged exposure therapy (PE', 'trauma-focused meditation versus exposure therapy']","['change in PTSD symptom severity', 'Clinician-Administered PTSD Scale (CAPS', 'CAPS score', 'TM', 'CAPS scores']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3714797', 'cui_str': 'Military service'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150814', 'cui_str': 'Transcendental Meditation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0150277'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0222045'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",203.0,0.170181,"TM was significantly non-inferior to PE on change in CAPS score from baseline to 3-month post-test (difference between groups in mean change -5·9,","[{'ForeName': 'Sanford', 'Initials': 'S', 'LastName': 'Nidich', 'Affiliation': 'Center for Social and Emotional Health, and Center for Natural Medicine and Prevention, Maharishi University of Management Research Institute, Fairfield, IA, USA. Electronic address: snidich@mum.edu.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mills', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA; Department of Family Medicine and Public Health, and Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Rainforth', 'Affiliation': 'Center for Social and Emotional Health, and Center for Natural Medicine and Prevention, Maharishi University of Management Research Institute, Fairfield, IA, USA.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Heppner', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA; Department of Family Medicine and Public Health, and Department of Psychiatry, University of California, San Diego, CA, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schneider', 'Affiliation': 'Center for Social and Emotional Health, and Center for Natural Medicine and Prevention, Maharishi University of Management Research Institute, Fairfield, IA, USA.'}, {'ForeName': 'Norman E', 'Initials': 'NE', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical School, Washington DC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Salerno', 'Affiliation': 'Center for Social and Emotional Health, and Center for Natural Medicine and Prevention, Maharishi University of Management Research Institute, Fairfield, IA, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Gaylord-King', 'Affiliation': 'Center for Social and Emotional Health, and Center for Natural Medicine and Prevention, Maharishi University of Management Research Institute, Fairfield, IA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rutledge', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA; Department of Family Medicine and Public Health, and Department of Psychiatry, University of California, San Diego, CA, USA.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(18)30384-5']
703,30737048,Impact of school-based nutrition and physical activity intervention on body mass index eight years after cessation of randomized controlled trial (AVall study).,"BACKGROUND & AIMS


The prevalence of obesity and overweight among children is increasing, representing a new and pressing societal problem. Excess weight in childhood is an independent risk factor for adult obesity. Although school-based interventions are generally considered effective in the short term, few studies analyze their longterm impact. The aim of study was to assess if the effect of the intervention on body mass Index (BMI) immediately after the intervention remained eight years later (AVall Study).
METHODS


In 2006-2008, an intervention for primary school children promoted healthy eating habits and physical activity in the school setting using the Investigation, Vision, Action and Change (IVAC) educational methodology, which involves children as active participants in healthy change. At baseline, parents reported their weight, height and educational level by questionnaire. Children's weight and height were measured in situ in 2006, 2008, 2010, 2012 and 2016, and levels of physical activity were assessed by questionnaire. Multilevel mixed effects linear regression was used to assess changes in BMI over time.
RESULTS


Increases in BMI from 2006 to 2016 were 0.68 kg/m 2  (95% CI, 0.02, 1.34; P = 0.045) higher in the control group than in the intervention group. The prevalence of obesity and overweight combined in 2006 and 2016 was 22.2% and 27.9%, respectively, in the control group and 25.6% and 21.2% respectively, in the intervention group. Changes in BMI in the intervention group were maintained from 2006 on: at the end of the intervention in 2008, -0.4 kg/m 2  (P = 0.001); in 2010, -0.23 g/m 2  (P = 0.012); in 2012, -0.63 kg/m 2  (P < 0.001) and in 2016, -0.27 kg/m 2  (P = 0.025). The child's BMI increased by 0.52 kg/m 2  (P = 0.046) if the father was obese, by 1.26 kg/m 2  (p = 0.011) if the mother was obese, and by 2.37 kg/m 2  (P < 0.001) if both parents were obese. Parental education levels were not associated with childhood obesity.
CONCLUSIONS


A school-based healthy eating habits and physical activity intervention using IVAC methodology contributed to lower increases in BMI among children in primary school. Although parental BMI also influenced children's BMI, the intervention was effective.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01156805.",2019,"The child's BMI increased by 0.52 kg/m 2  (P = 0.046) if the father was obese, by 1.26 kg/m 2  (p = 0.011) if the mother was obese, and by 2.37 kg/m 2  (P ",[],['school-based nutrition and physical activity intervention'],"['body mass Index (BMI', 'BMI', 'Changes in BMI', ""Children's weight and height"", ""child's BMI"", 'Parental education levels', 'healthy eating habits and physical activity', 'weight, height and educational level by questionnaire', 'prevalence of obesity and overweight combined']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",,0.0537335,"The child's BMI increased by 0.52 kg/m 2  (P = 0.046) if the father was obese, by 1.26 kg/m 2  (p = 0.011) if the mother was obese, and by 2.37 kg/m 2  (P ","[{'ForeName': 'Ma Assumpta', 'Initials': 'MA', 'LastName': 'Recasens', 'Affiliation': 'Internal Medicine Department, Granollers General Hospital, Granollers, Spain; Medicine Department, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Catalonia, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Xicola-Coromina', 'Affiliation': 'Primary Care, ABS Montornès-Montmeló, Catalan Institute of Health, Spain; Unitat de Suport a la Recerca Metropolitana Nord, IDIAP Jordi Gol, Sabadell, Spain.'}, {'ForeName': 'Josep-Maria', 'Initials': 'JM', 'LastName': 'Manresa', 'Affiliation': 'Unitat de Suport a la Recerca Metropolitana Nord, IDIAP Jordi Gol, Sabadell, Spain; Departament de Infermeria, Universitat Autònoma de Barcelona, Bellaterra, Spain.'}, {'ForeName': 'Pierre Antoine', 'Initials': 'PA', 'LastName': 'Ullmo', 'Affiliation': 'Tyme Education, Brussels, Belgium.'}, {'ForeName': 'Bjarne Bruun', 'Initials': 'BB', 'LastName': 'Jensen', 'Affiliation': 'Health Promotion Research, Steno Diabetes Centre, Gentofte, Denmark.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Franco', 'Affiliation': 'Public Health Department, Granollers City Council, Granollers, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Suarez', 'Affiliation': 'Internal Medicine Department, Granollers General Hospital, Granollers, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nadal', 'Affiliation': 'Public Health Department, Granollers City Council, Granollers, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vila', 'Affiliation': 'Internal Medicine Department, Granollers General Hospital, Granollers, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Recasens', 'Affiliation': 'Primary Health Subdivision (PHS) Granollers-Mollet, Catalan Institute of Health, Spain.'}, {'ForeName': 'M José', 'Initials': 'MJ', 'LastName': 'Pérez', 'Affiliation': 'Primary Health Subdivision (PHS) Granollers-Mollet, Catalan Institute of Health, Spain.'}, {'ForeName': 'Conxa', 'Initials': 'C', 'LastName': 'Castell', 'Affiliation': 'Public Health Agency, Department of Health, Generalitat de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Esteve', 'Initials': 'E', 'LastName': 'Llargués', 'Affiliation': 'Internal Medicine Department, Granollers General Hospital, Granollers, Spain; Medicine Department, Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, Catalonia, Spain. Electronic address: ellargues@fhag.es.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.12.029']
704,30919704,Validation of Strasbourg environmental exposure chamber (EEC) ALYATEC ®  in mite allergic subjects with asthma.,"Objective:  Environmental Exposure Chamber (EEC) should have standardized and controlled allergenic and non-allergenic exposures to perform reproducible clinical studies. The aim was to demonstrate that mite exposure in the Alyatec ®  EEC could induce early (EAR) and/or late asthmatic reactions (LAR) in at least 60% of subjects allergic to mite. Methods:  The EEC has a volume of 147-m 3  with 20 seats. The nebulized particle number, airborne Der p1, endotoxins, and volatile organic compound (VOC) concentrations were measured. Twenty-four asthmatics allergic to mite were randomly exposed to 15, 25, and 46 ng/m 3  Der p1. Specificity was assessed in not mite-sensitized asthmatics. Results:  No significant endotoxin or VOC contamination was measured. The mean inter-assay CVs were 12.5% for the airborne particle number and 28.7% for airborne Der p1 concentrations. For the three Der p1 concentrations, at least 88% of the subjects developed EAR and/or LAR, and at least 46% developed a dual response. No reaction occurred with placebo or in the control group. No severe bronchial reaction occurred. Conclusions:  The Alyatec ®  EEC demonstrated a tight control of allergenic and non-allergenic exposures. The EEC was clinically validated, with airborne Der p1 levels close to levels found in natural settings.",2020,"The nebulized particle number, airborne Der p1, endotoxins, and volatile organic compound (VOC) concentrations were measured.","['mite allergic subjects with asthma', 'Twenty-four asthmatics allergic to mite']","['Strasbourg environmental exposure chamber (EEC', 'placebo', 'Environmental Exposure Chamber (EEC']","['Specificity', 'mean inter-assay CVs', 'severe bronchial reaction', 'endotoxin or VOC contamination', 'EAR and/or LAR', 'airborne Der p1, endotoxins, and volatile organic compound (VOC) concentrations']","[{'cui': 'C0026231', 'cui_str': 'Mites'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C0014412', 'cui_str': 'Environmental Exposure'}, {'cui': 'C0600216', 'cui_str': 'Common Market'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C2350439', 'cui_str': 'Volatile Organic Compounds'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",24.0,0.0230995,"The nebulized particle number, airborne Der p1, endotoxins, and volatile organic compound (VOC) concentrations were measured.","[{'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Khayath', 'Affiliation': 'Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Doyen', 'Affiliation': 'Clinics of Immuno-Allergology, CHU Brugmann, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Gherasim', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Radu', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Choual', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Beck', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Jacob', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schoettel', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Vecellio', 'Affiliation': 'François-Rabelais University, Tours Cedex, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Domis', 'Affiliation': 'Biocluster des Haras, ALYATEC®, Strasbourg, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'de Blay', 'Affiliation': 'Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2018.1563902']
705,31757206,Doxapram alleviates low SpO 2  induced by the combination of propofol and fentanyl during painless gastrointestinal endoscopy.,"BACKGROUND


Painless gastrointestinal endoscopy under intravenous propofol anesthesia is widely applied in the clinical scenario. Despite the good sedation and elimination of anxiety that propofol provides, low SpO 2  may also result. Doxapram is a respiratory stimulant with a short half-life. The primary aim of this study was to investigate the effects of doxapram on alleviating low SpO 2  induced by the combination of propofol and fentanyl during painless gastrointestinal endoscopy.
METHODS


In this prospective study, patients scheduled for painless gastrointestinal endoscopy were randomly assigned to group D or S with 55 patients per group. Initially, both groups received a combination of propofol and fentanyl. Patients in group D received 50 mg doxapram after propofol injection, while patients in group S received an equal volume of saline. Vital signs of the patients, propofol dose, examination duration, and incidences of low SpO 2  were recorded.
RESULTS


There were no statistical differences in propofol consumption and examination duration between the two groups. Twenty-six patients in group S experienced low SpO 2  versus 10 in group D (P = 0.001). Nineteen patients in group S underwent oxygenation with a face mask in contrast to 8 in group D (P = 0.015). Eighteen patients in group S were treated with jaw lifting compared to 5 in group D (P = 0.002). Four patients in group S underwent assisted respiration compared to 2 in group D (without statistical difference). The average oxygen saturation in group S was significantly lower than that in group D at 1, 2 and 3 min after propofol injection (P < 0.001, P = 0.001 and P = 0.020, respectively). There were no statistical differences in oxygen saturation at other time points. There were no statistical differences in MAP and HR (except for the time point of 1 min after the induction) between the two groups.
CONCLUSIONS


Low dose of doxapram can effectively alleviate low SpO 2  in painless gastrointestinal endoscopy with intravenous propofol, without affecting propofol consumption, examination duration, MAP, or HR.
TRAIL REGISTRATION


The study was approved by the Institutional Ethics Committee of Clinical and New Technology of Wuxi People's Hospital on 20th July, 2018 (KYLLH2018029) and registered in the Chinese Clinical Trial Register on 16th August, 2018 (ChiCTR1800017832).",2019,"The average oxygen saturation in group S was significantly lower than that in group D at 1, 2 and 3 min after propofol injection (P < 0.001, P = 0.001 and P = 0.020, respectively).",['patients scheduled for painless gastrointestinal endoscopy'],"['50\u2009mg doxapram after propofol injection', 'equal volume of saline', 'propofol and fentanyl', 'doxapram', 'propofol anesthesia', 'Doxapram']","['propofol consumption, examination duration, MAP, or HR', 'MAP and HR', 'propofol consumption and examination duration', 'average oxygen saturation', 'oxygen saturation']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0234226', 'cui_str': 'Painless (qualifier value)'}, {'cui': 'C0079278', 'cui_str': 'Endoscopy, Gastrointestinal'}]","[{'cui': 'C0013084', 'cui_str': 'Doxapram'}, {'cui': 'C4282969', 'cui_str': 'Propofol Injection [Diprivan]'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",,0.0245606,"The average oxygen saturation in group S was significantly lower than that in group D at 1, 2 and 3 min after propofol injection (P < 0.001, P = 0.001 and P = 0.020, respectively).","[{'ForeName': 'Zhengfeng', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital Affiliated to Nanjing Medical University, 299 Qingyang Road, Wuxi, 214023, Jiangsu, China.""}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Xin', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital Affiliated to Nanjing Medical University, 299 Qingyang Road, Wuxi, 214023, Jiangsu, China. tomytomytomy123@sohu.com.""}, {'ForeName': 'Haoxing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital Affiliated to Nanjing Medical University, 299 Qingyang Road, Wuxi, 214023, Jiangsu, China.""}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital Affiliated to Nanjing Medical University, 299 Qingyang Road, Wuxi, 214023, Jiangsu, China.""}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital Affiliated to Nanjing Medical University, 299 Qingyang Road, Wuxi, 214023, Jiangsu, China.""}, {'ForeName': 'Shunmei', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital Affiliated to Nanjing Medical University, 299 Qingyang Road, Wuxi, 214023, Jiangsu, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital Affiliated to Nanjing Medical University, 299 Qingyang Road, Wuxi, 214023, Jiangsu, China.""}, {'ForeName': 'Yiling', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital Affiliated to Nanjing Medical University, 299 Qingyang Road, Wuxi, 214023, Jiangsu, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital Affiliated to Nanjing Medical University, 299 Qingyang Road, Wuxi, 214023, Jiangsu, China.""}]",BMC anesthesiology,['10.1186/s12871-019-0860-1']
706,31009528,Six Month Abstinence Heterogeneity in the Best Quit Study.,"BACKGROUND


Understanding the characteristics of smokers who are successful in quitting may help to increase smoking cessation rates.
PURPOSE


To examine heterogeneity in cessation outcome at 6 months following smoking cessation behavioral counseling with or without weight management counseling.
METHODS


2,540 smokers were recruited from a large quitline provider and then randomized to receive proactive smoking cessation behavioral counseling without or with two versions of weight management counseling. A Classification and Regression Tree (CART) analysis was conducted to identify the individual pretreatment and treatment characteristics of groups of smokers with different quitting success (as measured by point prevalence of self-reported smoking of any amount at 6 months).
RESULTS


CART analysis identified 10 subgroups ranging from 25.5% to 70.2% abstinent. The splits in the CART tree involved: the total number of counseling and control calls received, whether a smoking cessation pharmacotherapy was used, and baseline measures of cigarettes per day, confidence in quitting, expectation that the study would help the participant quit smoking, the motivation to quit, exercise minutes per week, anxiety, and lack of interest or pleasure in doing things. Costs per quitter ranged from a low of $US270 to a high of $US630. Specific treatment recommendations are made for each group.
CONCLUSIONS


These results indicate the presence of a substantial variation in abstinence following treatment, and that the total extent of contact via counseling calls of any type and baseline characteristics, rather than assigned treatment, were most important to subgroup membership and abstinence. Tailored treatments to subgroups who are at high risk for smoking following a quit attempt could increase successful smoking cessation.",2019,Costs per quitter ranged from a low of $US270 to a high of $US630.,"['2,540 smokers were recruited from a large quitline provider']","['smoking cessation behavioral counseling with or without weight management counseling', 'proactive smoking cessation behavioral counseling without or with two versions of weight management counseling']",['successful smoking cessation'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",2540.0,0.0261545,Costs per quitter ranged from a low of $US270 to a high of $US630.,"[{'ForeName': 'Harold S', 'Initials': 'HS', 'LastName': 'Javitz', 'Affiliation': 'Education Division, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Terry M', 'Initials': 'TM', 'LastName': 'Bush', 'Affiliation': 'Optum Center for Wellbeing Research, Optum, Seattle, WA USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Lovejoy', 'Affiliation': 'Optum Center for Wellbeing Research, Arivale, Inc and Institute for Systems Biology, Seattle, WA, USA.'}, {'ForeName': 'Alula J', 'Initials': 'AJ', 'LastName': 'Torres', 'Affiliation': 'Optum Center for Wellbeing Research, Optum, Seattle, WA USA.'}, {'ForeName': 'Tallie', 'Initials': 'T', 'LastName': 'Wetzel', 'Affiliation': 'Education Division, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Ken P', 'Initials': 'KP', 'LastName': 'Wassum', 'Affiliation': 'Optum Center for Wellbeing Research, Optum, Seattle, WA USA.'}, {'ForeName': 'Marcia M', 'Initials': 'MM', 'LastName': 'Tan', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Alshurafa', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz014']
707,30898339,Plasma copeptin levels predict disease progression and tolvaptan efficacy in autosomal dominant polycystic kidney disease.,"In the TEMPO 3:4 Trial, treatment with tolvaptan, a vasopressin V2 receptor antagonist, slowed the increase in total kidney volume and decline in estimated glomerular filtration rate (eGFR) in autosomal dominant polycystic kidney disease (ADPKD). We investigated whether plasma copeptin levels, a marker of plasma vasopressin, are associated with disease progression, and whether pre-treatment copeptin and treatment-induced change in copeptin are associated with tolvaptan treatment efficacy. This post hoc analysis included 1,280 TEMPO 3:4 participants (aged 18-50 years, estimated creatinine clearance ≥60 ml/min and total kidney volume ≥750 mL) who had plasma samples available at baseline for measurement of copeptin using an automated immunofluorescence assay. In placebo-treated subjects, baseline copeptin predicted kidney growth and eGFR decline over 3 years. These associations were independent of sex, age, and baseline eGFR, but were no longer statistically significant after additional adjustment for baseline total kidney volume. In tolvaptan-treated subjects, copeptin increased from baseline to week 3 (6.3 pmol/L versus 21.9 pmol/L, respectively). In tolvaptan-treated subjects with higher baseline copeptin levels, a larger treatment effect was noted with respect to kidney growth rate and eGFR decline. Tolvaptan-treated subjects with a larger percentage increase in copeptin from baseline to week 3 had a better disease outcome, with less kidney growth and eGFR decline after three years. Copeptin holds promise as a biomarker to predict outcome and tolvaptan treatment efficacy in ADPKD.",2019,"Tolvaptan-treated subjects with a larger percentage increase in copeptin from baseline to week 3 had a better disease outcome, with less kidney growth and eGFR decline after three years.","['autosomal dominant polycystic kidney disease', '1,280 TEMPO 3:4 participants (aged 18-50 years, estimated creatinine clearance\xa0≥60 ml/min and total kidney volume\xa0≥750 mL) who had plasma samples available at baseline for measurement of copeptin using an automated immunofluorescence assay']","['tolvaptan', 'placebo']","['kidney growth rate and eGFR decline', 'kidney growth and eGFR decline', 'plasma copeptin levels', 'copeptin', 'total kidney volume and decline in estimated glomerular filtration rate (eGFR']","[{'cui': 'C0085413', 'cui_str': 'ADPKD'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0056279', 'cui_str': 'C-terminal provasopressin'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0079603', 'cui_str': 'Immunofluorescence'}]","[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0056279', 'cui_str': 'C-terminal provasopressin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C3811844'}]",,0.0346573,"Tolvaptan-treated subjects with a larger percentage increase in copeptin from baseline to week 3 had a better disease outcome, with less kidney growth and eGFR decline after three years.","[{'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands. Electronic address: r.t.gansevoort@umcg.nl.'}, {'ForeName': 'Maatje D A', 'Initials': 'MDA', 'LastName': 'van Gastel', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Arlene B', 'Initials': 'AB', 'LastName': 'Chapman', 'Affiliation': 'Section of Nephrology, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Jaime D', 'Initials': 'JD', 'LastName': 'Blais', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Frank S', 'Initials': 'FS', 'LastName': 'Czerwiec', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Higashihara', 'Affiliation': 'Department of ADPKD Research, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Perrone', 'Affiliation': 'Department of Medicine, Division of Nephrology, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Stade', 'Affiliation': 'BRAHMS GmbH, Hennigsdorf, Germany.'}, {'ForeName': 'Vicente E', 'Initials': 'VE', 'LastName': 'Torres', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Devuyst', 'Affiliation': 'Institute of Physiology, University of Zurich, Zurich, Switzerland; and Division of Nephrology, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2018.11.044']
708,31239180,"Improving empowerment, motivation, and medical adherence in patients with poorly controlled type 2 diabetes: A randomized controlled trial of a patient-centered intervention.","OBJECTIVE


To test whether an intervention consisting of four patient-centered consultations improves glycemic control and self-management skills in patients with poorly regulated type 2 diabetes (T2DM), compared to a control group receiving usual care.
METHODS


Unblinded parallel randomized controlled trial including 97 adults diagnosed with T2DM ≥ 1 year and hemoglobin A1c (HbA1c) levels ≥ 8.0% (64 mmol/mol). Consultations incorporated tools supporting self-reflection, learning processes, and goal setting. Primary outcome was HbA1c. Secondary outcomes were autonomy support, motivation, self-management skills, and well-being.
RESULTS


Average HbA1c decreased slightly in both groups. Autonomy support and frequency of healthy eating were significantly higher in the intervention group. Most participants in the intervention group chose to set goals related to diet and physical exercise. Implementation of the intervention was inconsistent.
CONCLUSION


Despite increased autonomy support and individual goal-setting, the intervention was not superior to usual care in terms of glycemic control. More research is needed on how individual preferences and goals can be supported in practice to achieve sustainable behavior changes.
PRACTICE IMPLICATIONS


The intervention promoted participant engagement and supported exploration of participants' challenges and preferences. Further exploration of more flexible use of tools adapted to individual contexts is recommended.",2019,Autonomy support and frequency of healthy eating were significantly higher in the intervention group.,"['2 diabetes', '97 adults diagnosed with T2DM\u202f≥\u202f1\u202fyear and hemoglobin A1c (HbA1c) levels ≥ 8.0% (64\u202fmmol/mol', 'patients with poorly controlled type', 'patients with poorly regulated type 2 diabetes (T2DM']","['diet and physical exercise', 'control group receiving usual care']","['autonomy support, motivation, self-management skills, and well-being', 'autonomy support and individual goal-setting', 'Improving empowerment, motivation, and medical adherence', 'Autonomy support and frequency of healthy eating', 'glycemic control and self-management skills']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205169', 'cui_str': 'Bad (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",97.0,0.0547254,Autonomy support and frequency of healthy eating were significantly higher in the intervention group.,"[{'ForeName': 'Annemarie R', 'Initials': 'AR', 'LastName': 'Varming', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, DK-2820, Gentofte, Denmark. Electronic address: annemarie.varming@regionh.dk.'}, {'ForeName': 'Lone Banke', 'Initials': 'LB', 'LastName': 'Rasmussen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, DK-2820, Gentofte, Denmark. Electronic address: Lone.banke.rasmussen@regionh.dk.'}, {'ForeName': 'Gitte Reventlov', 'Initials': 'GR', 'LastName': 'Husted', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, DK-2820, Gentofte, Denmark. Electronic address: grh@pharmakon.dk.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Olesen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, DK-2820, Gentofte, Denmark. Electronic address: kasper.olesen@regionh.dk.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Grønnegaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, DK-2820, Gentofte, Denmark. Electronic address: cecilia.groennegaard.nielsen@regionh.dk.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Willaing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Niels Steensens Vej 6, DK-2820, Gentofte, Denmark. Electronic address: ingrid.willaing.tapager@regionh.dk.'}]",Patient education and counseling,['10.1016/j.pec.2019.06.014']
709,30927644,Antioxidant vitamin supplementation prevents oxidative stress but does not enhance performance in young football athletes.,"OBJECTIVES


The aim of this study was to verify the effects of supplementation with antioxidants (vitamins C and E) on oxidative stress, delayed-onset muscle soreness (DOMS), and performance in football players during a recovery period after an exercise-induced oxidative stress protocol.
METHODS


Twenty-one football athletes were randomly assigned to two groups: placebo and antioxidant-supplemented. Supplementation was performed in a double-blind, controlled manner using vitamin C (500 mg/d) and E (400 UI/d) for 15 d. After 7 d of supplementation, athletes were submitted to an exercise-induced oxidative stress protocol consisting of plyometric jumping and strength resistance sets to exhaustion. Blood samples, performance tests, and DOMS were determined before and 24, 48, and 72 h after exercise.
RESULTS


Antioxidant supplementation was continued during the recuperation week and for a total of 15 d. Antioxidant supplementation caused a significant increase in plasma vitamins C and E. The antioxidant supplementation could inhibit oxidative stress characterized by elevated lipid peroxidation markers malondialdehyde and total lipid peroxidation as well as reduced ratio of glutathione to oxidized glutathione promoted by exercise. Antioxidant supplementation, however, did not significantly reduce the plasma creatine kinesis concentration or DOMS during the recovery days. Likewise, supplementation with vitamin C and E did not improve lower body power, agility, or anaerobic power, nor did it provide any indication of faster muscle recovery.
CONCLUSION


Antioxidant supplementation does not attenuate elevated markers of muscle damage or muscle soreness promoted by acute exercise and do not exert any ergogenic effect on football performance of young athletes, although it reduced oxidative stress.",2019,The antioxidant supplementation could inhibit oxidative stress characterized by elevated lipid peroxidation markers malondialdehyde and total lipid peroxidation as well as reduced ratio of glutathione to oxidized glutathione promoted by exercise.,"['young football athletes', 'Twenty-one football athletes']","['vitamin C', 'Likewise, supplementation with vitamin C and E', 'supplementation with antioxidants (vitamins C and E', 'antioxidant supplementation', 'exercise-induced oxidative stress protocol consisting of plyometric jumping and strength resistance sets to exhaustion', 'Antioxidant supplementation', 'Antioxidant vitamin supplementation', 'placebo and antioxidant-supplemented']","['oxidative stress', 'plasma vitamins C and E', 'Blood samples, performance tests, and DOMS', 'lower body power, agility, or anaerobic power', 'oxidative stress, delayed-onset muscle soreness (DOMS), and performance in football players', 'plasma creatine kinesis concentration or DOMS', 'lipid peroxidation markers malondialdehyde and total lipid peroxidation']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C1533658', 'cui_str': 'Vitamin supplement therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0022699', 'cui_str': 'Kinesis'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023775', 'cui_str': 'Lipid Peroxidation'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",21.0,0.433882,The antioxidant supplementation could inhibit oxidative stress characterized by elevated lipid peroxidation markers malondialdehyde and total lipid peroxidation as well as reduced ratio of glutathione to oxidized glutathione promoted by exercise.,"[{'ForeName': 'Donizete C X', 'Initials': 'DCX', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Physical Education, Faculty of Physical Education and Sport, State University of Londrina, Londrina, PR, Brazil.'}, {'ForeName': 'Flavia Troncon', 'Initials': 'FT', 'LastName': 'Rosa', 'Affiliation': 'Department of Physical Education, Faculty of Physical Education and Sport, State University of Londrina, Londrina, PR, Brazil; Nutrition, Filadelfia University Center, Londrina, PR, Brazil.'}, {'ForeName': 'Lívia', 'Initials': 'L', 'LastName': 'Simões-Ambrósio', 'Affiliation': 'Nutrition and Metabolism, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil.'}, {'ForeName': 'Alceu Afonso', 'Initials': 'AA', 'LastName': 'Jordao', 'Affiliation': 'Nutrition and Metabolism, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Deminice', 'Affiliation': 'Department of Physical Education, Faculty of Physical Education and Sport, State University of Londrina, Londrina, PR, Brazil. Electronic address: rdeminice@uel.br.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.01.007']
710,30922152,Effects of Exercise Interventions on Habitual Physical Activity and Sedentary Behavior in Adolescents With Cerebral Palsy.,"PURPOSE


Exercise interventions have been shown to increase motor capacities in adolescents with cerebral palsy; however, how they affect habitual physical activity (HPA) and sedentary behavior is unclear. The main objective was to correlate changes in HPA with changes in mobility capacity following exercise interventions.
METHODS


A total of 54 participants (aged 12-20 y) with bilateral spastic cerebral palsy at Gross Motor Function Classification System (GMFCS) levels II and III received 4 months of group progressive resistance training or treadmill training. Mobility measurements and HPA (averaged over 96 h) were made before and after interventions.
RESULTS


Averaged baseline mobility and HPA measures and improvements in each after both interventions were positively correlated in all participants. Percentage of sedentary/awake time decreased 2%, with significant increases in HPA measures of step count (16%), walk time (14%), and upright time (9%). Mobility measures and HPA changes were quite similar between Gross Motor Function Classification System levels, but improvement in HPA after group progressive resistance training was greater than after treadmill training (12% vs 4%) and correlated with mobility improvement.
CONCLUSIONS


Mobility capacity improved after these interventions and was clearly associated with improved HPA. The group progressive resistance training intervention seems preferable to improve HPA, perhaps related to greater social interaction and motivation provided by group training.",2019,"Mobility measures and HPA changes were quite similar between Gross Motor Function Classification System levels, but improvement in HPA after group progressive resistance training was greater than after treadmill training (12% vs 4%) and correlated with mobility improvement.  ","['Adolescents With Cerebral Palsy', '54 participants (aged 12-20\xa0y) with bilateral spastic cerebral palsy at Gross Motor Function Classification System (GMFCS) levels II and III received 4 months of group', 'adolescents with cerebral palsy']","['Exercise Interventions', 'Exercise interventions', 'progressive resistance training intervention', 'progressive resistance training or treadmill training']","['HPA after group progressive resistance training', 'walk time', 'HPA measures of step count', 'Mobility capacity', 'upright time', 'Mobility measurements and HPA', 'motor capacities', 'mobility improvement', 'Habitual Physical Activity and Sedentary Behavior', 'Percentage of sedentary/awake time', 'Mobility measures and HPA changes', 'HPA']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3838784', 'cui_str': 'Bilateral spastic cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441926', 'cui_str': 'Level II (tumor staging)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",54.0,0.0127144,"Mobility measures and HPA changes were quite similar between Gross Motor Function Classification System levels, but improvement in HPA after group progressive resistance training was greater than after treadmill training (12% vs 4%) and correlated with mobility improvement.  ","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bar-Haim', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Aviram', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Shkedy Rabani', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Amro', 'Affiliation': 'Al-Quds University.'}, {'ForeName': 'Ibtisam', 'Initials': 'I', 'LastName': 'Nammourah', 'Affiliation': 'Cambridge Medical & Rehabilitation Center.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Al-Jarrah', 'Affiliation': 'Jordan University of Science and Technology.'}, {'ForeName': 'Yoav', 'Initials': 'Y', 'LastName': 'Raanan', 'Affiliation': 'Ben-Gurion University of the Negev.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Loeppky', 'Affiliation': 'VA Medical Center.'}, {'ForeName': 'Netta', 'Initials': 'N', 'LastName': 'Harries', 'Affiliation': 'Assaf Harofeh Medical Center.'}]",Pediatric exercise science,['10.1123/pes.2018-0254']
711,30642738,"Effect of oral citrulline supplementation on whole body protein metabolism in adult patients with short bowel syndrome: A pilot, randomized, double-blind, cross-over study.","BACKGROUND & AIMS


As citrulline is produced by small intestine, plasma citrulline concentration is decreased and may become essential in patients with short bowel syndrome (SBS). In a rat model of SBS, citrulline supplementation enhanced muscle protein synthesis. The aim of the study was to determine whether citrulline impacts whole body protein metabolism in patients with SBS.
METHODS


Nine adults with non-malignant SBS (residual small bowel 90 ± 48 cm; mean ± SD) who were in near-normal nutritional status without any artificial nutrition, were recruited long after surgery. They received 7-day oral supplementation with citrulline (0.18 g/kg/day), or an iso-nitrogenous placebo in a randomized, double-blind, cross-over design with a 13-day wash-out between regimens, and an intravenous 5-h infusion of L-[1- 13 C]-leucine in the postabsorptive state to assess protein metabolism after each regimen.
RESULTS


Plasma citrulline concentration rose 17-fold (25 ± 9 vs. 384 ± 95 μmol/L) and plasma arginine 3-fold after oral citrulline supplementation (both p < 4 × 10 -6 ). Supplementation did not alter leucine appearance rate (97 ± 5 vs. 97 ± 5 μmol kg -1 .h -1 ; p = 0.88), leucine oxidation (14 ± 1 vs. 12 ± 1 μmol kg -1 .h -1 ; p = 0.22), or non-oxidative leucine disposal (NOLD), an index of whole-body protein synthesis (83 ± 4 vs. 85 ± 5 μmol kg -1 .h -1 ; p = 0.36), nor insulin or IGF-1 plasma concentrations. In each of the 3 patients with baseline citrulline<20 μmol/L, citrulline supplementation increased NOLD. Among the 7 patients with plasma citrulline <30 μmol/L, the effect of supplementation on NOLD correlated inversely (r 2  = 0.81) with baseline plasma citrulline concentration.
CONCLUSION


1) Oral citrulline supplementation enhances citrulline and arginine bioavailability in SBS patients. 2) Oral citrulline supplementation does not have any anabolic effect on whole body protein metabolism in patients with SBS in good nutritional status, in the late phase of intestinal adaptation, and with near-normal baseline citrulline homeostasis. 3) Whether oral citrulline would impact whole body protein anabolism in severely malnourished SBS patients in the early adaptive period, and with baseline plasma citrulline below 20 μmol/L, warrants further study. Registered under ClinicalTrials.gov Identifier no. NCT01386034.",2019,Supplementation did not alter leucine appearance rate (97 ± 5 vs. 97 ± ,"['Nine adults with non-malignant SBS (residual small bowel 90\xa0±', 'SBS patients', '83\xa0±\xa04 vs. 85\xa0±', 'severely malnourished SBS patients in the early adaptive period, and with baseline plasma citrulline below 20\xa0μmol/L, warrants further study', '48\xa0cm; mean\xa0±\xa0SD) who were in near-normal nutritional status without any artificial nutrition, were recruited long after surgery', 'patients with SBS', 'adult patients with short bowel syndrome', 'patients with short bowel syndrome (SBS', 'patients with SBS in good nutritional status']","['citrulline supplementation', 'placebo', 'oral citrulline', 'Oral citrulline supplementation', 'leucine oxidation (14\xa0±', 'SBS, citrulline supplementation', '7-day oral supplementation with citrulline', 'oral citrulline supplementation']","['leucine appearance rate', 'nor insulin or IGF-1 plasma concentrations', 'citrulline and arginine bioavailability', 'Plasma citrulline concentration', 'NOLD', 'plasma arginine', 'whole body protein metabolism', 'non-oxidative leucine disposal (NOLD), an index of whole-body protein synthesis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0036992', 'cui_str': 'Short Bowel Syndrome'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]","[{'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",9.0,0.253249,Supplementation did not alter leucine appearance rate (97 ± 5 vs. 97 ± ,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Jirka', 'Affiliation': 'Nutrition Support Team, Division of Gastroenterology, IMAD, University Hospital, Nantes, France; INRA UMR 1280 PHAN, University of Nantes, IMAD, CRNH-Ouest, France.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Layec', 'Affiliation': 'Nutrition Department, Clinique St-Yves, Rennes, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Picot', 'Affiliation': 'Nutrition Department, Clinique St-Yves, Rennes, France.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bernon-Ferreira', 'Affiliation': 'INRA UMR 1280 PHAN, University of Nantes, IMAD, CRNH-Ouest, France.'}, {'ForeName': 'Nadège', 'Initials': 'N', 'LastName': 'Grasset', 'Affiliation': 'INRA UMR 1280 PHAN, University of Nantes, IMAD, CRNH-Ouest, France; Department of Dietetics, University Hospital, Nantes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Flet', 'Affiliation': 'Pharmacy Department, University Hospital, Nantes, France.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Thibault', 'Affiliation': 'INSERM, INRA, Univ Rennes, Nutrition Metabolism and Cancer, NuMeCan, Nutrition Unit, CHU Rennes, Rennes, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Darmaun', 'Affiliation': 'Nutrition Support Team, Division of Gastroenterology, IMAD, University Hospital, Nantes, France; INRA UMR 1280 PHAN, University of Nantes, IMAD, CRNH-Ouest, France. Electronic address: ddarmaun@chu-nantes.fr.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.12.030']
712,30946860,Restoring emotional stability: Cortisol effects on the neural network of cognitive emotion regulation.,"Effective emotion regulation in stressful contexts is a key feature of mental health. Acute stress, however, impairs prefrontal top-down control, probably leading to a decline of emotion regulatory capacities. By contrast, the delayed cortisol increase in response to a stressor or after a pharmacological manipulation has been linked to mood-protecting effects and emotion regulation success. In this functional magnetic resonance imaging study, healthy men and women received either 30 mg cortisol or placebo 90 min before they were exposed to an emotion regulation paradigm involving neutral and negative pictures. As expected, behavioural and brain imaging data indicated successful induction and downregulation of negative emotions via cognitive reappraisal and distraction. Cortisol enhanced regulatory activity in the ventrolateral prefrontal cortex when participants used distraction and reduced emotion-related activation in the amygdala when regulating emotions via cognitive reappraisal. Together, these findings provide first evidence for a delayed glucocorticoid-induced facilitation of cognitive emotion regulation processes that might be beneficial for restoring emotional stability in the aftermath of stressful events.",2019,Cortisol enhanced regulatory activity in the ventrolateral prefrontal cortex when participants used distraction and reduced emotion-related activation in the amygdala when regulating emotions via cognitive reappraisal.,['healthy men and women'],['30\u2009mg cortisol or placebo'],['Cortisol enhanced regulatory activity'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0313214,Cortisol enhanced regulatory activity in the ventrolateral prefrontal cortex when participants used distraction and reduced emotion-related activation in the amygdala when regulating emotions via cognitive reappraisal.,"[{'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Jentsch', 'Affiliation': 'Institute of Cognitive Neuroscience, Department of Cognitive Psychology, Ruhr University Bochum, Germany. Electronic address: valerie.kinner@rub.de.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Merz', 'Affiliation': 'Institute of Cognitive Neuroscience, Department of Cognitive Psychology, Ruhr University Bochum, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Institute of Cognitive Neuroscience, Department of Cognitive Psychology, Ruhr University Bochum, Germany.'}]",Behavioural brain research,['10.1016/j.bbr.2019.03.049']
713,30908365,"Effects of Different Weekly Sets-Equated Resistance Training Frequencies on Muscular Strength, Muscle Mass, and Body Fat in Older Women.","Pina, FLC, Nunes, JP, Schoenfeld, BJ, Nascimento, MA, Gerage, AM, Januário, RSB, Carneiro, NH, Cyrino, ES, and Oliveira, AR. Effects of different weekly sets-equated resistance training frequencies on muscular strength, muscle mass and body fat in older women. J Strength Cond Res 34(10): 2990-2995, 2020-The aim of this study was to analyze the effects of different resistance training (RT) frequencies (2 vs. 3 times per week) with an equivalent number of weekly sets performed between conditions on muscular strength and body composition in older women. Forty-seven older women (65 ± 4 years) were divided into 2 groups that performed a 12-week RT program either 2 (G2x and 3 sets) or 3 (G3x and 2 sets) times per week. The groups were evaluated before and after study on measures of body composition through dual-energy x-ray absorptiometry, and muscular strength through one repetition maximum (1RM) testing. Lean soft tissue was significantly increased in both groups (G2x = +1.7%, G3x = +1.7%), while only G3x reduced body fat after the intervention period (G2x = -0.7%, G3x = -2.9%). Similarly, significant increases were noted between conditions for 1RM scores in bench press (G2x = +11.8%, G3x = +11.9%) and knee extension (G2x = +17.4%, G3x = +10.8%). The results indicate that performing 2 or 3 RT sessions per week promotes similar improvements in muscular outcomes, while training more frequently may reduce body fat after 12 weeks of weekly sets-equated RT in untrained older women.",2020,"Lean soft tissue was significantly increased in both groups (G2x = +1.7%, G3x = +1.7%), while only G3x reduced body fat after the intervention period (G2x = -0.7%, G3x = -2.9%).","['untrained older women', 'older women', 'Forty-seven older women (65 ± 4 years', 'Older Women']","['J Strength Cond Res XX(X', 'Different Weekly Sets-Equated Resistance Training Frequencies', 'resistance training (RT) frequencies']","['muscular outcomes', 'body composition through dual-energy x-ray absorptiometry, and muscular strength through one repetition maximum (1RM) testing', 'Lean soft tissue', 'knee extension', 'Pina, FLC, Nunes, JP, Schoenfeld, BJ, Nascimento, MA, Gerage, AM, Januário, RSB, Carneiro, NH, Cyrino, ES, and Oliveira, AR', 'muscular strength, muscle mass and body fat', '1RM scores', 'Muscular Strength, Muscle Mass, and Body Fat']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0445567', 'cui_str': 'Pina (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",47.0,0.0114104,"Lean soft tissue was significantly increased in both groups (G2x = +1.7%, G3x = +1.7%), while only G3x reduced body fat after the intervention period (G2x = -0.7%, G3x = -2.9%).","[{'ForeName': 'Fábio L C', 'Initials': 'FLC', 'LastName': 'Pina', 'Affiliation': 'Center for Research in Health Sciences, University of Northern Paraná, Londrina, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Health Sciences, Lehman College, Bronx, New York.'}, {'ForeName': 'Matheus A', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Aline M', 'Initials': 'AM', 'LastName': 'Gerage', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Renata S B', 'Initials': 'RSB', 'LastName': 'Januário', 'Affiliation': 'Center for Research in Health Sciences, University of Northern Paraná, Londrina, Brazil.'}, {'ForeName': 'Nelson H', 'Initials': 'NH', 'LastName': 'Carneiro', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Arli R', 'Initials': 'AR', 'LastName': 'Oliveira', 'Affiliation': 'Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003130']
714,30528951,Common polymorphism in the cannabinoid receptor gene type 2 (CB2R) rs3123554 are associated with metabolic changes after two different hypocaloric diets with different dietary fatty profiles.,"BACKGROUND


The role of CB2R gene variants on weight loss after a dietary intervention has been investigated in few studies.
OBJECTIVE


We evaluate the effect of this genetic variant (rs3123554) of CB2R gene on cardiovascular risk factors and weight loss secondary to high monounsaturated fat vs a high polyunsaturated fat hypocaloric diets.
DESIGN


A Caucasian population of 362 obese patients was enrolled. Patients were randomly allocated during 3 months to one of two diets (Diet P high polyunsaturated (PUFAs) fat hypocaloric diet vs, Diet M high monounsaturated (MUFAs) fat hypocaloric diet).
RESULTS


In both genotype groups (GG vs GA+AA), body weight, body mass index (BMI), fat mass, waist circumference and systolic blood pressure decreased after diet P and M. Body weight, BMI, fat mass and waist circumference were higher in A allele carriers than non A allele carriers. The improvement of these parameters was higher in non A allele carriers than A allele carriers. In non A allele carriers with both diets, the decrease of total cholesterol, LDL-cholesterol, insulin and HOMA-IR was higher than A allele carriers after both diets. After diet P, triglyceride levels decrease in non A allele carriers.
CONCLUSION


Our data suggest that carriers of the minor allele of rs3123554 variant of CB2R gene lose less body weight during to different hypocaloric diets with different fatty acid. Moreover, non A-allele carriers showed a better response of LDL-cholesterol, HOMA-IR and insulin levels than A-carriers with both hypocaloric diets.",2019,"Moreover, non A-allele carriers showed a better response of LDL-cholesterol, HOMA-IR and insulin levels than A-carriers with both hypocaloric diets.",['A Caucasian population of 362 obese patients was enrolled'],"['genetic variant (rs3123554) of CB2R gene', 'diets (Diet P high polyunsaturated (PUFAs) fat hypocaloric diet vs, Diet M high monounsaturated (MUFAs) fat hypocaloric diet']","['weight loss', 'total cholesterol, LDL-cholesterol, insulin and HOMA-IR', 'LDL-cholesterol, HOMA-IR and insulin levels', 'body weight, body mass index (BMI), fat mass, waist circumference and systolic blood pressure', 'triglyceride levels decrease', 'body weight']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2362518', 'cui_str': 'Polyunsaturated fat (substance)'}, {'cui': 'C2362517', 'cui_str': 'Monounsaturated fat (substance)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",362.0,0.0264826,"Moreover, non A-allele carriers showed a better response of LDL-cholesterol, HOMA-IR and insulin levels than A-carriers with both hypocaloric diets.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aller', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Dpt of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Dpt of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Dpt of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'de Luis', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, Medicine School and Dpt of Endocrinology and Investigation, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain. Electronic address: dadluis@yahoo.es.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.11.013']
715,26151998,Effect of skin contact between mother and child in pain relief of full-term newborns during heel blood collection.,"OBJECTIVES


The aim was to investigate the effect of skin contact between mother and child in pain relief of full-term newborns during heel blood collection.
MATERIALS AND METHODS


The authors randomly divided 40 full-term newborns into two groups. In the experimental group, the newborn received kangaroo care from the mother before, during, and after the 20-minute heel blood collection. In the control group, the heel blood collection was performed under conventional conditions. The authors compared the two groups' heart rate, oxygen saturation, facial expressions of pain, and duration of crying.
RESULTS


The two groups had no statistically significant difference in terms of gender, birth weight, mode of delivery, and gestational age (p > 0.05). In the seven time periods during the puncture after ten seconds from the beginning and ten seconds after the end, the neonatal heart rates of the two groups changed and statistically significant differences were observed in the duration of heel blood collection, interaction and group factors, as well as in oxygen saturation (p < 0.01).
CONCLUSIONS


During heel blood collection, skin contact between the mother and child can relieve pain, reduce changes in heart rate, improve neonatal heel blood oxygen saturation, and enhance the emotional communication between the mother and child.",2015,"The two groups had no statistically significant difference in terms of gender, birth weight, mode of delivery, and gestational age (p > 0.05).",['mother and child in pain relief of full-term newborns during heel blood collection'],[],"['gender, birth weight, mode of delivery, and gestational age', 'heel blood collection', 'duration of heel blood collection, interaction and group factors, as well as in oxygen saturation', 'heart rate, improve neonatal heel blood oxygen saturation, and enhance the emotional communication', 'heart rate, oxygen saturation, facial expressions of pain, and duration of crying', 'neonatal heart rates']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0005768'}, {'cui': 'C0600644', 'cui_str': 'Collection'}]",[],"[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0005768'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen (observable entity)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}]",40.0,0.0196751,"The two groups had no statistically significant difference in terms of gender, birth weight, mode of delivery, and gestational age (p > 0.05).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
716,26152000,Time-limited hydrotubation combined with clomiphene citrate treatment for unexplained infertility.,"PURPOSE


To evaluate time-limited hydrotubation combined with clomiphene citrate as treatment for unexplained infertility.
MATERIALS AND METHODS


In this unblinded, randomized controlled trial of patients who had unexplained infertility, 40 patients were treated with time-limited hydrotubation (saline, 20 ml; flushed within 20 to 30 seconds) and clomphene citrate (total, 70 cycles) and 40 patients were treated with clomiphene citrate alone (total, 74 cycles). All women underwent an ovulation induction protocol with clomiphene citrate (100 mg/d orally for five days, from day 3 to day 7 of the cycle). Hydrotubation was performed after detection of the dominant follicle.
RESULTS


There were 15 pregnancies in the 80 patients (19%) (total, 144 stimulated cycles; 10% pregnancies per cycle). The frequency of clinical pregnancy per cycle was significantly greater in patients who were treated with hydrotubation and clomiphene citrate (nine pregnancies per cycle [13%]) than those treated with clomiphene citrate alone (two pregnancies per cycle [3%]; odds ratio, 5.3; 95% confidence interval, 1.1 to 25.5; p ≤ 0.05). The frequency of pregnancy per patient (total, clinical, or chemical) was similar for the two treatment groups. The frequency of live birth or abortion per cycle or patient was similar between the two treatment groups.
CONCLUSION


Time-limited hydrotubation and clomiphene citrate may increase the frequency of clinical pregnancy per cycle in women who have unexplained infertility.",2015,"The frequency of clinical pregnancy per cycle was significantly greater in patients who were treated with hydrotubation and clomiphene citrate (nine pregnancies per cycle [13%]) than those treated with clomiphene citrate alone (two pregnancies per cycle [3%]; odds ratio, 5.3; 95% confidence interval, 1.1 to 25.5; p ≤ 0.05).","['women who have unexplained infertility', 'unexplained infertility', 'patients who had unexplained infertility, 40 patients were treated with']","['clomiphene citrate', 'clomiphene citrate alone', 'time-limited hydrotubation (saline, 20 ml; flushed within 20 to 30 seconds) and clomphene citrate']","['frequency of live birth or abortion per cycle or patient', 'frequency of pregnancy per patient (total, clinical, or chemical', 'frequency of clinical pregnancy per cycle']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4285761', 'cui_str': 'Hydrotubation'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0376259', 'cui_str': 'Citrate'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0220806', 'cui_str': 'Chemical (substance)'}]",40.0,0.133704,"The frequency of clinical pregnancy per cycle was significantly greater in patients who were treated with hydrotubation and clomiphene citrate (nine pregnancies per cycle [13%]) than those treated with clomiphene citrate alone (two pregnancies per cycle [3%]; odds ratio, 5.3; 95% confidence interval, 1.1 to 25.5; p ≤ 0.05).","[{'ForeName': 'O E', 'Initials': 'OE', 'LastName': 'Yapca', 'Affiliation': ''}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Delibas', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Karaca', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kumtepe', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kadanali', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
717,31926340,"Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis.","BACKGROUND & AIMS


New oral therapeutic agents are needed for patients with ulcerative colitis (UC) who are unresponsive or intolerant to conventional therapy.
METHODS


We performed a double-blind, phase 2 trial of adults with active UC for 3 months or more who were naïve to biologic therapy or had been failed by, could not tolerate, or had contraindications to conventional therapies. The study was performed at 61 sites in 14 countries (screening from January 2015 through May 2017). Patients were randomly assigned to groups given apremilast 30 mg (n = 57), apremilast 40 mg (n = 55), or placebo (n = 58) twice daily for 12 weeks; patients were then randomly assigned to groups that received apremilast, 30 or 40 mg twice daily, for an additional 40 weeks. Endoscopies were performed and biopsies were collected during the screening phase, at week 12, and at week 52. Blood and fecal samples were also collected and analyzed throughout the study. The primary endpoint was clinical remission at week 12, defined as a total Mayo score of 2 or less, with no individual subscore above 1.
RESULTS


Clinical remission was achieved at week 12 by 31.6% of patients in the 30 mg apremilast group and 12.1% of patients in the placebo group (P = .01). However, only 21.8% of patients in the 40 mg apremilast group achieved clinical remission at week 12 (P = .27 compared with placebo). Differences in clinical remission between the 30 mg and 40 mg apremilast groups were associated with differences in endoscopic improvement. Both apremilast groups had similar improvements from baseline in Mayo score components (stool frequency score, rectal bleeding score, physician's global assessment). The 30 mg and 40 mg apremilast groups had greater median percent reductions in C-reactive protein (measured by a high-sensitivity blood test) and fecal calprotectin through week 12 than the placebo group. At week 52, clinical remission was achieved by 40.4% of patients initially assigned to the apremilast 30 mg group and 32.7% of patients initially assigned to the apremilast 40 mg group. The most frequent apremilast-associated adverse events were headache and nausea.
CONCLUSIONS


Although the primary endpoint of clinical remission was not met in this phase 2 trial, a greater proportion of patients with active UC who received apremilast (30 mg or 40 mg) had improvements in clinical and endoscopic features, and markers of inflammation, at 12 weeks. Clinical remission was maintained to week 52 in up to 40% of patients who continued apremilast until that time point. ClinicalTrials.gov no: NCT02289417.",2020,Clinical remission was maintained to week 52 in up to 40% of patients who continued apremilast until that time point.,"['61 sites in 14 countries (screening from January 2015 through May 2017', 'adults with active UC for 3 months or more who were naïve to biologic therapy or had been failed by, could not tolerate, or had contraindications to conventional therapies', 'patients with ulcerative colitis (UC) who are unresponsive or intolerant to conventional therapy', 'Patients With Active Ulcerative Colitis']",['placebo'],"['clinical and endoscopic features, and markers of inflammation', 'total Mayo score of 2 or less, with no individual subscore above 1', 'clinical remission', 'Clinical remission', 'median percent reductions in C-reactive protein', 'fecal calprotectin', ""Mayo score components (stool frequency score, rectal bleeding score, physician's global assessment"", 'Blood and fecal samples', 'headache and nausea', 'endoscopic improvement']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0005527', 'cui_str': 'Biologic Therapy'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0005768'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.208769,Clinical remission was maintained to week 52 in up to 40% of patients who continued apremilast until that time point.,"[{'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Humanitas Clinical and Research Center - IRCCS, Milan, Italy; Humanitas University, Department of Biomedical Sciences, Milan, Italy. Electronic address: silvio.danese@humanitasresearch.it.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Neurath', 'Affiliation': 'Department of Internal Medicine, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kopoń', 'Affiliation': 'Department of Gastroenterology, Toruńskie Centrum Gastrologiczne Gastromed, Toruń, Poland.'}, {'ForeName': 'Salam F', 'Initials': 'SF', 'LastName': 'Zakko', 'Affiliation': 'Connecticut Clinical Research Institute, Bristol Hospital, Bristol, Connecticut.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Simmons', 'Affiliation': 'West Gastroenterology Medical Group, Los Angeles, California.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Clinical Research Institute of Michigan, Digestive Health Center of Michigan, Chesterfield, Michigan.'}, {'ForeName': 'Corey A', 'Initials': 'CA', 'LastName': 'Siegel', 'Affiliation': 'Department of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Inflammatory Bowel Disease Clinic, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Xiaojiang', 'Initials': 'X', 'LastName': 'Zhan', 'Affiliation': 'Clinical Research, Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Usiskin', 'Affiliation': 'Clinical Research, Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Denesh', 'Initials': 'D', 'LastName': 'Chitkara', 'Affiliation': 'Clinical Research, Celgene Corporation, Summit, New Jersey.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.12.032']
718,30900194,Effects of Dog Assisted Therapy for Adults with Autism Spectrum Disorder: An Exploratory Randomized Controlled Trial.,"Effective treatments of highly prevalent stress-related outcomes such as depression and anxiety are understudied in adults with autism spectrum disorder (ASD). A randomized controlled trial with baseline, post-intervention, and 10-week follow-up, that explores the effects of animal assisted therapy (AAT) was conducted. In total, 53 adults with ASD with normal to high intelligence were randomized in an intervention (N = 27) versus waiting list control group (N = 26). The remarkable adherence to the therapy program by study participants and the program's clinically relevant effects indicate that AAT with dogs can be used to reduce perceived stress and symptoms of agoraphobia, and to improve social awareness and communication in adults with ASD with normal to high intelligence.",2020,"The remarkable adherence to the therapy program by study participants and the program's clinically relevant effects indicate that AAT with dogs can be used to reduce perceived stress and symptoms of agoraphobia, and to improve social awareness and communication in adults with ASD with normal to high intelligence.","['Spectrum Disorder', '53 adults with ASD with normal to high intelligence', 'Adults with Autism', 'adults with autism spectrum disorder (ASD', 'adults with ASD with normal to high intelligence']","['waiting list control', 'animal assisted therapy (AAT', 'Dog Assisted Therapy']",[],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150133', 'cui_str': 'Animal Facilitated Therapy'}, {'cui': 'C0012984', 'cui_str': 'Canis familiaris'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],53.0,0.0770418,"The remarkable adherence to the therapy program by study participants and the program's clinically relevant effects indicate that AAT with dogs can be used to reduce perceived stress and symptoms of agoraphobia, and to improve social awareness and communication in adults with ASD with normal to high intelligence.","[{'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Wijker', 'Affiliation': 'GGZ Oost Brabant, P.O. Box 3, 5427 ZG, Boekel, The Netherlands. carolien.wijker@ou.nl.'}, {'ForeName': 'Ruslan', 'Initials': 'R', 'LastName': 'Leontjevas', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Open University of the Netherlands, Heerlen, The Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Spek', 'Affiliation': 'Autism Center of Expertise, Eemnes, The Netherlands.'}, {'ForeName': 'Marie-Jose', 'Initials': 'MJ', 'LastName': 'Enders-Slegers', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Open University of the Netherlands, Heerlen, The Netherlands.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03971-9']
719,26152008,"Novasure impedance control system versus microwave endometrial ablation for the treatment of dysfunctional uterine bleeding: a double-blind, randomized controlled trial.","PURPOSE OF INVESTIGATION


To compare the efficacy and safety of two different second-generation ablation devices, Novasure impedance control system and microwave endometrial ablation (MEA), in cases of abnormal uterine bleeding (AUB).
MATERIALS AND METHODS


This is a randomized controlled trial that took place in a single Gynecological Department of a University Hospital. Sixty-six women with dysfunctional uterine bleeding (DUB), unresponsive to medical treatment, were included in the trial. The ratio of women allocated to bipolar radio-frequency ablation or MEA was 1:1. Follow-up assessments were carried out at three and 12 months post-ablation. The present main outcome measure was amenorrhea rates 12-months post-treatment.
RESULTS


The rate of amenorrhea at 12-months post-ablation was significantly higher in women treated by Novasure (25/33; 75.8%) as compared to those treated by MEA (8/33; 24.2%) (rate difference: +51.5%, 95% CI: +27.8 to +67.7).
CONCLUSION


In women with DUB, endometrial ablation with Novasure bipolar radiofrequency impedance-controlled system is associated with increased rates of amenorrhea at 12-months post-treatment as compared to the MEA method.",2015,"In women with DUB, endometrial ablation with Novasure bipolar radiofrequency impedance-controlled system is associated with increased rates of amenorrhea at 12-months post-treatment as compared to the MEA method.","['single Gynecological Department of a University Hospital', 'cases of abnormal uterine bleeding (AUB', 'Sixty-six women with dysfunctional uterine bleeding (DUB), unresponsive to medical treatment, were included in the trial', 'dysfunctional uterine bleeding']","['Novasure impedance control system versus microwave endometrial ablation', 'bipolar radio-frequency ablation or MEA', 'second-generation ablation devices, Novasure impedance control system and microwave endometrial ablation (MEA']","['rates of amenorrhea', 'amenorrhea rates 12-months post-treatment', 'rate of amenorrhea at 12-months post-ablation', 'efficacy and safety']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding (disorder)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025874', 'cui_str': 'Dysfunctional Uterine Bleeding'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0026051', 'cui_str': 'Microwaves'}, {'cui': 'C0341803', 'cui_str': 'Endometrial Ablation'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",66.0,0.17099,"In women with DUB, endometrial ablation with Novasure bipolar radiofrequency impedance-controlled system is associated with increased rates of amenorrhea at 12-months post-treatment as compared to the MEA method.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Athanatos', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pados', 'Affiliation': ''}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Venetis', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stamatopoulos', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rousso', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tsolakidis', 'Affiliation': ''}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Stamatopoulos', 'Affiliation': ''}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Tarlatzis', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
720,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE


For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS


In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS


A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION


To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
721,30829142,Counselor turnover in substance use disorder treatment research: Observations from one multisite trial.,"Background:  Counselor workforce turnover is a critical area of concern for substance use disorder (SUD) treatment providers and researchers. To facilitate the adoption and implementation of innovative treatments, attention must be paid to how SUD treatment workforce issues affect the implementation of clinical effectiveness research. Multiple variables have been shown to relate to turnover, yet reasons that are specific to conducting research have not been systematically assessed.  Methods:  In a randomized clinical trial testing a sexual risk reduction counselor training intervention, 69 counselors at 4 outpatient SUD treatment sites (2 opioid treatment programs [OTPs], 2 psychosocial) were enrolled and randomized to 1 of 2 training conditions (Standard vs. Enhanced). Study counselor and agency turnover rates were calculated. Agency context and policies that impacted research participation were examined.  Results:  Study turnover rates for enrolled counselors were substantial, ranging from 33% to 74% over approximately a 2-year active study period. Study counselor turnover was significantly greater at outpatient psychosocial programs versus OTPs. Counselor turnover did not differ due to demographic or training condition assignment. Leaving agency employment was the most typical reason for study counselor turnover.  Conclusions:  This secondary analysis used data from a multisite study with frontline counselors to provide a qualitative description of challenges faced when conducting effectiveness research in SUD treatment settings. That counselors may be both subjects and deliverers of the interventions studied in clinical trials, with implications for differential impact on study implementation, is highlighted. We offer suggestions for researchers seeking to implement effectiveness research in SUD clinical service settings.",2019,Study counselor turnover was significantly greater at outpatient psychosocial programs versus OTPs.,"['69 counselors at 4 outpatient SUD treatment sites (2 opioid treatment programs [OTPs], 2 psychosocial']",['sexual risk reduction counselor training intervention'],"['Counselor turnover', 'agency turnover rates', 'Study counselor turnover']","[{'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0337950', 'cui_str': 'Site of care'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",,0.0389812,Study counselor turnover was significantly greater at outpatient psychosocial programs versus OTPs.,"[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Hatch-Maillette', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Harwick', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Baer', 'Affiliation': 'Department of Psychology, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Masters', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'Kasie', 'Initials': 'K', 'LastName': 'Cloud', 'Affiliation': 'CODA Inc. , Portland , Oregon , USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Peavy', 'Affiliation': 'Evergreen Treatment Services , Seattle , Washington , USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wiest', 'Affiliation': 'CODA Inc. , Portland , Oregon , USA.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Beadnell', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Wells', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington , Seattle , Washington , USA.'}]",Substance abuse,['10.1080/08897077.2019.1572051']
722,30850310,Examining the Effects of an Adolescent Pregnancy Prevention Program by Risk Profiles: A More Nuanced Approach to Program Evaluation.,"PURPOSE


The objective of the study was to examine whether latent class analysis (LCA) could (1) identify distinct subgroups of youth characterized by multiple risk and protective factors for early sexual initiation and (2) allow for a more nuanced assessment of the effects of a middle school program to prevent teen pregnancy/HIV/sexually transmitted infection.
METHODS


LCA was applied to data from the baseline (seventh grade) sample of 1,693 sexually inexperienced students participating in a randomized controlled trial of It's Your Game…Keep It Real in Harris County, Texas. Multilevel analysis was applied within subgroups defined by the latent classes to assess for potential differential program effects.
RESULTS


LCA identified 3 distinct profiles of youth: family disruption, other language household, and frequent religious attendance. Multilevel analyses found differential effects of the program across these profiles with a significant and substantial reduction (30%) in initiation of vaginal sex by ninth grade for students in the family disruption profile only.
CONCLUSIONS


Application of LCA may hold promise for conducting more nuanced evaluations and refinements of behavior change interventions for youth.",2019,"Multilevel analyses found differential effects of the program across these profiles with a significant and substantial reduction (30%) in initiation of vaginal sex by ninth grade for students in the family disruption profile only.
","[""1,693 sexually inexperienced students participating in a randomized controlled trial of It's Your Game""]","['Adolescent Pregnancy Prevention Program', 'LCA', 'latent class analysis (LCA']",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0032968', 'cui_str': 'Pregnancy, Adolescent'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4704739', 'cui_str': 'Latent Variable Modeling'}]",[],1693.0,0.0322458,"Multilevel analyses found differential effects of the program across these profiles with a significant and substantial reduction (30%) in initiation of vaginal sex by ninth grade for students in the family disruption profile only.
","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Vasilenko', 'Affiliation': 'Syracuse University, Department of Human Development and Family Science, Syracuse, New York. Electronic address: savasile@syr.edu.'}, {'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Glassman', 'Affiliation': 'ETR Associates, Scotts Valley, California.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Kugler', 'Affiliation': 'Pennsylvania State University, Department of Biobehavioral Health and the Methodology Center, University Park, Pennsylvania.'}, {'ForeName': 'Melissa F', 'Initials': 'MF', 'LastName': 'Peskin', 'Affiliation': 'University of Texas Health Science Center, School of Public Health, Houston, Texas.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Shegog', 'Affiliation': 'University of Texas Health Science Center, School of Public Health, Houston, Texas.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Markham', 'Affiliation': 'University of Texas Health Science Center, School of Public Health, Houston, Texas.'}, {'ForeName': 'Susan Tortolero', 'Initials': 'ST', 'LastName': 'Emery', 'Affiliation': 'University of Texas Health Science Center, School of Public Health, Houston, Texas.'}, {'ForeName': 'Karin K', 'Initials': 'KK', 'LastName': 'Coyle', 'Affiliation': 'ETR Associates, Scotts Valley, California.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2018.12.003']
723,30849931,Acute Effects of Interrupting Prolonged Sitting With Intermittent Physical Activity on Blood Pressure in Preadolescent Children.,"PURPOSE


To compare the acute effects of intermittent physical activity (PA) across 4 different intensities on blood pressure.
METHODS


Thirty children (12 males and 18 females; aged 7-11 y; 33% overweight/obese; 53% nonwhite) completed 4 experimental conditions in random order: 8 hours sitting interrupted with 20, 2-minute low-, moderate-, high-intensity PA breaks, or sedentary screen-time breaks. PA intensity corresponded with 25%, 50%, and 75% of heart rate reserve. Blood pressure was measured during each condition in the morning (0800 h), noon (1200 h), and afternoon (1600 h).
RESULTS


There were no significant differences across conditions for systolic blood pressure (SBP; all Ps > .05). There was a significant effect of time with SBP decreasing throughout the day for all conditions (average morning SBP: 106 [1] mm Hg, average noon SBP: 101 [2] mm Hg, average afternoon SBP: 103 [1] mm Hg; P = .01). There were no significant effects of condition or time on diastolic blood pressure (all Ps > .05).
CONCLUSION


While sedentary behavior is known to be associated with hypertension in both adults and children, a single bout of prolonged sitting may be insufficient to produce hypertensive effects in otherwise healthy children. Future research should examine the appropriate dose of intermittent PA to accrue hypotensive responses in preadolescent children.",2019,There were no significant differences across conditions for systolic blood pressure (SBP; all Ps > .05).,"['preadolescent children', 'aged 7-11\xa0y; 33% overweight/obese; 53% nonwhite) completed 4 experimental conditions in random order: 8', 'Thirty children (12 males and 18 females', 'Preadolescent Children']","['intermittent physical activity (PA', 'hours sitting interrupted with 20, 2-minute low-, moderate-, high-intensity PA breaks, or sedentary screen-time breaks', 'Prolonged Sitting With Intermittent Physical Activity']","['PA intensity', 'time with SBP', 'Blood Pressure', 'condition or time on diastolic blood pressure', 'systolic blood pressure', 'Blood pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",30.0,0.0442614,There were no significant differences across conditions for systolic blood pressure (SBP; all Ps > .05).,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Weston', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nagy', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Tiwaloluwa A', 'Initials': 'TA', 'LastName': 'Ajibewa', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Block', 'Affiliation': 'University of Michigan.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Hasson', 'Affiliation': 'University of Michigan.'}]",Pediatric exercise science,['10.1123/pes.2018-0224']
724,30851861,The iCook 4-H Study: An Intervention and Dissemination Test of a Youth/Adult Out-of-School Program.,"OBJECTIVE


To describe outcomes from intervention and dissemination of iCook 4-H.
DESIGN


Five-state, community-based participatory research and a randomized, controlled trial followed by a 5-state, nonrandomized dissemination test of the iCook 4-H curriculum with control and treatment groups.
SETTING


Community and university sites.
PARTICIPANTS


Youths aged 9-10 years and their adult food preparer; 228 dyads in the intervention and 74 dyads in dissemination.
INTERVENTION(S)


Theoretical frameworks were Social Cognitive Theory and the experiential 4-H learning model. Six 2-hour, biweekly sessions on cooking, eating, and playing together followed by monthly newsletters and boosters until 24 months, expanded to 8 sessions for dissemination.
MAIN OUTCOME MEASURE(S)


Youth body mass index (BMI) z-scores, measured height and weight, and youth/adult program outcome evaluations surveys.
ANALYSIS


Linear mixed models, group, time, and group × time interaction for BMI z-score and program outcomes changes. Significance levels = P ≤ .05; interaction term significance = P ≤ .10.
RESULTS


In intervention, treatment BMI z-scores increased compared with controls based on significant interaction (P = .04). For odds of being overweight or obese at 24 months, there was no significant interaction (P = .18). In dissemination, based on significant interaction, treatment youths increased cooking skills (P = .03) and treatment adults increased cooking together (P = .08) and eating together (P = .08) compared with controls.
CONCLUSIONS AND IMPLICATIONS


iCook 4-H program outcomes were positive for mealtime activities of cooking and eating together. The program can be successfully implemented by community educators. The increase in BMI z-scores needs further evaluation for youths in cooking programs.",2019,"In dissemination, based on significant interaction, treatment youths increased cooking skills (P = .03) and treatment adults increased cooking together (P = .08) and eating together (P = .08) compared with controls.
","['Youth/Adult Out-of-School Program', 'Community and university sites', 'Youths aged 9-10 years and their adult food preparer; 228 dyads in the intervention and 74 dyads in dissemination']",[],"['BMI) z-scores, measured height and weight, and youth/adult program outcome evaluations surveys', 'Youth body mass index', 'mealtime activities of cooking and eating together', 'cooking skills', 'BMI z-scores', 'treatment BMI z-scores']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0283478,"In dissemination, based on significant interaction, treatment youths increased cooking skills (P = .03) and treatment adults increased cooking together (P = .08) and eating together (P = .08) compared with controls.
","[{'ForeName': 'Adrienne A', 'Initials': 'AA', 'LastName': 'White', 'Affiliation': 'School of Food and Agriculture, University of Maine, Orono, ME. Electronic address: awhite@maine.edu.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Colby', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Franzen-Castle', 'Affiliation': 'Nutrition and Health Sciences Department, University of Nebraska-Lincoln, Lincoln, NE.'}, {'ForeName': 'Kendra K', 'Initials': 'KK', 'LastName': 'Kattelmann', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Brookings, SD.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Olfert', 'Affiliation': 'Davis College of Agriculture, Natural Resources, and Design, Division of Animal and Nutritional Sciences, West Virginia University, Morgantown, WV.'}, {'ForeName': 'Tara A', 'Initials': 'TA', 'LastName': 'Gould', 'Affiliation': 'School of Food and Agriculture, University of Maine, Orono, ME.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Hagedorn', 'Affiliation': 'Davis College of Agriculture, Natural Resources, and Design, Division of Animal and Nutritional Sciences, West Virginia University, Morgantown, WV.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Mathews', 'Affiliation': 'School of Food and Agriculture, University of Maine, Orono, ME.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Moyer', 'Affiliation': 'School of Public Health and Health Sciences, Department of Biostatistics and Epidemiology, University of Massachusetts, Amherst, MA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Department of Health and Nutritional Sciences, South Dakota State University, Extension, Brookings, SD.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Yerxa', 'Affiliation': 'University of Maine Cooperative Extension, Orono, ME.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2018.11.012']
725,30052894,Real-world vs. randomized trial outcomes in similar populations of rivaroxaban-treated patients with non-valvular atrial fibrillation in ROCKET AF and XANTUS.,"AIMS


Based on Phase III data, non-vitamin K antagonist oral anticoagulants are recommended for stroke prevention in patients with atrial fibrillation. To determine whether trial outcomes translate into similar event rates in unselected patients, this analysis compared outcomes from the real-world XANTUS study with those from the Phase III ROCKET AF study.
METHODS AND RESULTS


Individual patient data from 4020 XANTUS patients were re-weighted to match the proportion of selected baseline characteristics in 7061 rivaroxaban-treated patients from ROCKET AF, using the matching-adjusted indirect comparison (MAIC) method. For the primary analysis, CHADS2 scores and gender were selected as relevant variables. Adjusted annualized incidence rates for XANTUS were calculated and compared with incidence rates from ROCKET AF-the ratio of these rates ('MAIC ratio') was used as a relative effect estimate. Rates of major bleeding [3.10%/year vs. 3.60%/year; MAIC ratio 0.86; 95% confidence interval (CI) 0.67-1.12] and stroke/non-central nervous system systemic embolism (1.54%/year vs. 1.70%/year; MAIC ratio 0.91; 95% CI 0.62-1.32) were similar between XANTUS and ROCKET AF. The rate of all-cause death was higher in XANTUS (3.22%/year vs. 1.87%/year; MAIC ratio 1.72; 95% CI 1.31-2.27), but the rates of vascular death were similar (1.83%/year vs. 1.53%/year; MAIC ratio 1.19; 95% CI 0.84-1.70). Sensitivity analyses weighted by different baseline characteristics supported these results.
CONCLUSION


The low rates of major bleeding and stroke in XANTUS were consistent with results from ROCKET AF. All-cause death, but not vascular death, was higher in XANTUS, as expected in an unselected real-world population.",2019,Rates of major bleeding [3.10%/year vs. 3.60%/year; MAIC ratio 0.86; 95% confidence interval (CI) 0.67-1.12] and stroke/non-central nervous system systemic embolism (1.54%/year vs. 1.70%/year; MAIC ratio 0.91; 95% CI 0.62-1.32) were similar between XANTUS and ROCKET AF.,"['treated patients with non-valvular atrial fibrillation in ROCKET AF and XANTUS', 'patients with atrial fibrillation', 'Individual patient data from 4020 XANTUS patients were re-weighted to match the proportion of selected baseline characteristics in 7061', 'unselected patients']","['rivaroxaban-treated patients from ROCKET AF', 'rivaroxaban', 'vitamin K antagonist oral anticoagulants']","['vascular death', 'low rates of major bleeding and stroke', 'Rates of major bleeding', 'stroke/non-central nervous system systemic embolism', 'rate of all-cause death', 'rates of vascular death']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",,0.439182,Rates of major bleeding [3.10%/year vs. 3.60%/year; MAIC ratio 0.86; 95% confidence interval (CI) 0.67-1.12] and stroke/non-central nervous system systemic embolism (1.54%/year vs. 1.70%/year; MAIC ratio 0.91; 95% CI 0.62-1.32) were similar between XANTUS and ROCKET AF.,"[{'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""Cardiovascular and Cell Sciences Research Institute, St George's, University of London, London, UK.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology and Stroke Centre, Paris-Diderot-Sorbonne University, Paris, France.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Haas', 'Affiliation': 'Formerly Institute for Experimental Oncology and Therapy Research, Technical University of Munich, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Hess', 'Affiliation': 'Medical Affairs, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Paulus', 'Initials': 'P', 'LastName': 'Kirchhof', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, UHB and Sandwell and West Birmingham Hospitals NHS Trusts, Birmingham, UK.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lambelet', 'Affiliation': 'Chrestos Concept GmbH & Co. KG, Essen, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Bach', 'Affiliation': 'Medical Affairs, Bayer AG, Berlin, Germany.'}, {'ForeName': 'Alexander G G', 'Initials': 'AGG', 'LastName': 'Turpie', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euy160']
726,30793786,Optimising the two-stage randomised trial design when some participants are indifferent in their treatment preferences.,"Outcomes in a clinical trial can be affected by any underlying preferences that its participants have for the treatments under comparison and by whether they actually receive their preferred treatment. These effects cannot be evaluated in standard trial designs but are estimable in the alternative two-stage randomised trial design, in which some patients can choose their treatment, while the rest are randomly assigned. We have previously shown that, when all two-stage trial participants have a preferred treatment, the preference effects can be evaluated, in addition to the usual direct effect of treatment. We also determined criteria by which to optimise how many participants should be given a choice of treatment vs being randomised. More recently, we extended our methodology to allow for participants who are unable or unwilling to express a treatment preference if they are assigned to the choice group. In this paper, we show how to optimise the two-stage design when some participants are undecided about their treatment. We demonstrate that the undecided group should be regarded as distinct in the analysis, to obtain valid estimates of the preference effects. We derive the optimal proportion of participants who should be offered a choice of treatment, which in many cases will be close to 50%. More generally, the optima depend on the preference rates for treatments and the proportion of undecided participants, and the parameters of primary interest. We discuss some advantages and disadvantages of the two-stage trial design in this situation and describe a practical example.",2019,"We derive the optimal proportion of participants who should be offered a choice of treatment, which in many cases will be close to 50%.",['participants who are unable or unwilling to express a treatment preference if they are assigned to the choice group'],[],[],"[{'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0558080', 'cui_str': 'Unwilling (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],[],,0.104798,"We derive the optimal proportion of participants who should be offered a choice of treatment, which in many cases will be close to 50%.","[{'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Walter', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Turner', 'Affiliation': 'Biostatistics Unit, Division of Health Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Macaskill', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}]",Statistics in medicine,['10.1002/sim.8119']
727,30825083,Brief Report: Effectiveness of an Accelerated Version of the PEERS® Social Skills Intervention for Adolescents.,"Evidence supporting the effectiveness of the PEERS® social skills intervention for adolescents with autism spectrum disorder is relatively strong. Less is known about whether the duration of the program impacts participant outcomes. The current study compared outcomes of participants randomly assigned to participate in an accelerated version of PEERS that met twice weekly for 7 weeks (n = 11) or the traditional PEERS program that met once weekly for 14 weeks (n = 10). The accelerated PEERS group demonstrated improvements consistent with previous research on the program, and treatment response did not differ significantly between the accelerated PEERS and traditional PEERS groups. Together, findings provide preliminary evidence that PEERS is effective when administered as a 7-week program.",2020,"The accelerated PEERS group demonstrated improvements consistent with previous research on the program, and treatment response did not differ significantly between the accelerated PEERS and traditional PEERS groups.","['adolescents with autism spectrum disorder', 'Adolescents']","['PEERS® social skills intervention', 'PEERS® Social Skills Intervention', 'traditional PEERS program']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.0361825,"The accelerated PEERS group demonstrated improvements consistent with previous research on the program, and treatment response did not differ significantly between the accelerated PEERS and traditional PEERS groups.","[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Matthews', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA. nmatthews@autismcenter.org.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Laflin', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Beatriz C', 'Initials': 'BC', 'LastName': 'Orr', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Warriner', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'DeCarlo', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Smith', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, 85006, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03939-9']
728,31629767,Is weight status associated with peripheral levels of oxytocin? A pilot study in healthy women.,"The neuropeptide oxytocin is best known for its role during parturition and the milk-let down reflex. Recent evidence identifies a role for oxytocin in eating behaviour. After oxytocin administration, caloric intake is reduced with stronger inhibitory effects in individuals with obesity. Whether the experience of visual food cues affects secretion or circulating levels of oxytocin is unknown. This pilot study had three aims: 1) to measure fasting appetite hormones with a focus on plasma oxytocin concentrations; 2) determine whether healthy vs. hyperpalatable visual food cues differentially altered plasma oxytocin; and 3) assess whether appetite hormone responses to healthy vs. hyperpalatable food images depended on weight or food addiction status. Eighteen healthy women of varying weight status, with/without self-reported food addiction were recruited. Study participants completed a set of standardised questionnaires, including Yale Food Addiction Scale, and attended a one-off experimental session. Blood was collected before and after viewing two sets of food images (healthy and hyperpalatable foods). Participants were randomly allocated in a crossover design to view either healthy images or hyperpalatable foods first. A positive correlation between BMI and plasma oxytocin was found (r 2  = 0.32, p = 0.021) at baseline. Oxytocin levels were higher, and cholecystokinin levels lower, in food addicted (n = 6) vs. non-food addicted females (p = 0.015 and p<0.001, respectively). There were no significant changes (p>0.05) in plasma oxytocin levels in response to either healthy or hyperpalatable food images. Given that endogenous oxytocin administration tends to suppress eating behaviour; these data indicate that oxytocin receptor desensitization or oxytocin resistance may be important factors in the pathogenesis of obesity and food addiction. However, further studies in larger samples are needed to determine if peripheral oxytocin is responsive to visual food cues.",2019,"Oxytocin levels were higher, and cholecystokinin levels lower, in food addicted (n=6) vs. non-food addicted females (p=0.015 and p<0.001, respectively).","['individuals with obesity', 'healthy women', 'Eighteen healthy women of varying weight status, with/without self-reported food addiction were recruited']","['healthy vs. hyperpalatable visual food cues differentially altered plasma oxytocin', 'healthy images or hyperpalatable foods first', 'endogenous oxytocin', 'oxytocin', 'neuropeptide oxytocin']","['BMI and plasma oxytocin', 'cholecystokinin levels', 'plasma oxytocin levels', 'Yale Food Addiction Scale', 'Oxytocin levels', 'weight or food addiction status']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0008328', 'cui_str': 'pancreozymin (cholecystokinin)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0222045'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",18.0,0.0702076,"Oxytocin levels were higher, and cholecystokinin levels lower, in food addicted (n=6) vs. non-food addicted females (p=0.015 and p<0.001, respectively).","[{'ForeName': 'Janelle A', 'Initials': 'JA', 'LastName': 'Skinner', 'Affiliation': 'Nutrition and Dietetics, School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Callaghan NSW 2308, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Manohar L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Christopher V', 'Initials': 'CV', 'LastName': 'Dayas', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, Faculty of Health and Medicine, University of Newcastle, Callaghan NSW 2308, Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'Nutrition and Dietetics, School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Callaghan NSW 2308, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan NSW 2308, Australia. Electronic address: tracy.burrows@newcastle.edu.au.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112684']
729,30721572,Randomized trial comparing effects of weight loss by liraglutide with lifestyle modification in non-alcoholic fatty liver disease.,"BACKGROUND & AIMS


We compared the effects of weight loss induced with the glucagon-like peptide-1 agonist liraglutide, with that of lifestyle modification, followed by weight maintenance after discontinuing intervention, in obese adults with non-alcoholic fatty liver disease (NAFLD).
METHODS


Thirty obese (mean age 40.7 ± 9.1 years, BMI 33.2 ± 3.6 kg/m 2  , 90% male) adults with NAFLD defined as liver fat fraction (LFF) > 5% on magnetic resonance imaging without other causes of hepatic steatosis were randomized to a supervised programme of energy restriction plus moderate-intensity exercise to induce ≥ 5% weight loss (DE group, n = 15), or liraglutide 3 mg daily (LI group, n = 15) for 26 weeks, followed by 26 weeks with only advice to prevent weight regain.
RESULTS


Diet and exercise and LI groups had significant (P < 0.01) and similar reductions in weight (-3.5 ± 3.3 vs -3.0 ± 2.2 kg), LFF (-8.1 ± 13.2 vs -7.0 ± 7.1%), serum alanine aminotransferase (-39 ± 35 vs -26 ± 33 U/L) and caspase-cleaved cytokeratin-18 (cCK-18) (-206 ± 252 vs -130 ± 158 U/L) at 26 weeks. At 52 weeks, the LI group significantly (P < 0.05) regained weight (1.8 ± 2.1 kg), LFF (4.0 ± 5.3%) and cCK-18 (72 ± 126 U/L), whereas these were unchanged in the DE group.
CONCLUSIONS


Liraglutide was effective for decreasing weight, hepatic steatosis and hepatocellular apoptosis in obese adults with NAFLD, but benefits were not sustained after discontinuation, in contrast with lifestyle modification. Continuing the exercise learned in the structured programme contributed to the maintenance of liver fat reduction.",2019,"At 52 weeks, the LI group significantly (P < 0.05) regained weight (1.8 ± 2.1 kg), LFF (4.0 ± 5.3%) and cCK-18 (72 ± 126 U/L), whereas these were unchanged in the DE group.
","['Thirty obese (mean age 40.7\xa0±', 'without other causes of hepatic steatosis', 'non-alcoholic fatty liver disease', 'obese adults with non-alcoholic fatty liver disease (NAFLD', 'obese adults with NAFLD']","['supervised programme of energy restriction plus moderate-intensity exercise to induce ≥ 5% weight loss (DE group, n\xa0=\xa015), or liraglutide 3\xa0mg daily (LI', 'glucagon-like peptide-1 agonist liraglutide', 'magnetic resonance imaging', 'Liraglutide', 'liraglutide']","['weight, hepatic steatosis and hepatocellular apoptosis', 'serum alanine aminotransferase', 'liver fat fraction (LFF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2711227', 'cui_str': 'Liver Steatosis'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]",,0.129569,"At 52 weeks, the LI group significantly (P < 0.05) regained weight (1.8 ± 2.1 kg), LFF (4.0 ± 5.3%) and cCK-18 (72 ± 126 U/L), whereas these were unchanged in the DE group.
","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Khoo', 'Affiliation': 'Department of Endocrinology, Changi General Hospital, Singapore.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Hsiang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Ranu', 'Initials': 'R', 'LastName': 'Taneja', 'Affiliation': 'Department of Diagnostic Radiology, Changi General Hospital, Singapore.'}, {'ForeName': 'Seok-Hwee', 'Initials': 'SH', 'LastName': 'Koo', 'Affiliation': 'Clinical Trials and Research Unit, Changi General Hospital, Singapore.'}, {'ForeName': 'Gaik-Hong', 'Initials': 'GH', 'LastName': 'Soon', 'Affiliation': 'Clinical Trials and Research Unit, Changi General Hospital, Singapore.'}, {'ForeName': 'Carmen J', 'Initials': 'CJ', 'LastName': 'Kam', 'Affiliation': 'Clinical Trials and Research Unit, Changi General Hospital, Singapore.'}, {'ForeName': 'Ngai-Moh', 'Initials': 'NM', 'LastName': 'Law', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Tiing-Leong', 'Initials': 'TL', 'LastName': 'Ang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14065']
730,31690537,Education with a multimedia web platform improves knowledge and HbA1c of Mexican patients with type 2 diabetes. Open clinical trial.,"INTRODUCTION


The patient with diabetes mellitus type requires to receive education about the disease aimed at improving knowledge and skills for their control. The objective of this study is to evaluate the efficacy of nutritional therapy and education through a multimedia site on the level of knowledge and metabolic control in patients with type 2 diabetes.
PATIENTS AND METHODS


Open-label clinical trial of 12 months of follow-up in 161 patients with type 2 diabetes. A total of 101 patients were assigned to the intervention group with nutrition therapy (TN) + Nutriluv (multimedia site in diabetes), 80 patients to the TN control group. The glycosylated hemoglobin (HbA1c), glucose, cholesterol, triglycerides, LDL and HDL cholesterol were measured at the beginning and end. Weight, waist circumference, percentage of fat, systolic blood pressure and diastolic blood pressure were recorded. The level of knowledge was measured with the Diabetes Knowledge Questionnaire (DKQ24).
RESULTS


The knowledge in diabetes improved in the group with TN+Nutriluv compared with the TN group (P<0.05). HbA1c, HDL, diastolic blood pressure and waist circumference, improved in the group with TN+Nutriluv (P<0.05). In the group with TN, cholesterol HDL, diastolic blood pressure, waist circumference and the fat percentage was increased (P<0.05). They had a higher risk of having an HbA1c>7% who had more years of diagnosis of diabetes.
CONCLUSIONS


The use of a multimedia site with education in diabetes, improves knowledge, HbA1c, and other indicators of cardiovascular risk in diabetes type 2 patients.",2020,"HbA1c, HDL, diastolic blood pressure and waist circumference, improved in the group with TN+Nutriluv (P<0.05).","['Mexican patients with type 2 diabetes', 'diabetes type 2 patients', 'Open-label clinical trial of 12 months of follow-up in 161 patients with type 2 diabetes', '101 patients', 'patients with type 2 diabetes']","['nutritional therapy and education through a multimedia site', 'intervention group with nutrition therapy (TN) + Nutriluv (multimedia site in diabetes', 'multimedia web platform']","['Diabetes Knowledge Questionnaire (DKQ24', 'glycosylated hemoglobin (HbA1c), glucose, cholesterol, triglycerides, LDL and HDL cholesterol', 'cholesterol HDL, diastolic blood pressure, waist circumference and the fat percentage', 'Weight, waist circumference, percentage of fat, systolic blood pressure and diastolic blood pressure', 'HbA1c, HDL, diastolic blood pressure and waist circumference', 'level of knowledge', 'knowledge in diabetes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1320657', 'cui_str': 'Diabetes type'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2937349', 'cui_str': 'Nutrition Therapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",161.0,0.0287842,"HbA1c, HDL, diastolic blood pressure and waist circumference, improved in the group with TN+Nutriluv (P<0.05).","[{'ForeName': 'Thalia', 'Initials': 'T', 'LastName': 'Reséndiz Lara', 'Affiliation': 'Unidad de Medicina Familiar No 28, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Abril Violeta', 'Initials': 'AV', 'LastName': 'Muñoz Torres', 'Affiliation': 'Departamento de Salud Pública, Facultad de Medicina, Universidad Nacional Autónoma de México, Ciudad de México, México.'}, {'ForeName': 'Grecia', 'Initials': 'G', 'LastName': 'Mendoza Salmerón', 'Affiliation': 'Nutrición, Universidad Iberoamericana Sede Santa Fe, Ciudad de México, México.'}, {'ForeName': 'Diego Damián', 'Initials': 'DD', 'LastName': 'Zendejas Vela', 'Affiliation': 'Nutrición, Universidad Iberoamericana Sede Santa Fe, Ciudad de México, México.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Medina Bravo', 'Affiliation': 'Departamento de Endocrinología, Hospital Infantil de México Federico Gómez, Secretarıa de Salud, Ciudad de México, México.'}, {'ForeName': 'Ivonne', 'Initials': 'I', 'LastName': 'Roy García', 'Affiliation': 'División de Desarrollo de la Investigación, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.'}, {'ForeName': 'Lubia', 'Initials': 'L', 'LastName': 'Velázquez López', 'Affiliation': 'Unidad de Investigación en Epidemiología Clínica, Hospital Carlos Mac Gregor Sánchez Navarro, Instituto Mexicano del Seguro Social, Ciudad de México, México. Electronic address: lubia2002@yahoo.com.mx.'}]","Endocrinologia, diabetes y nutricion",['10.1016/j.endinu.2019.07.011']
731,31888766,"Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial.","BACKGROUND


Micronutrient deficiencies including selenium (Se) are widespread in Malawi and potentially underlie a substantial disease burden, particularly among poorer and marginalised populations. Concentrations of Se in staple cereal crops can be increased through application of Se fertilisers - a process known as agronomic biofortification (agro-biofortification) - and this may contribute to alleviating deficiencies. The Addressing Hidden Hunger with Agronomy (AHHA) trial aims to establish the efficacy of this approach for improving Se status in rural Malawi.
METHODS


A double-blind, randomised, controlled trial will be conducted in a rural community in Kasungu District, Central Region, Malawi. The hypothesis is that consumption of maize flour agro-biofortified with Se will increase serum Se concentration. We will recruit 180 women of reproductive age (WRA) (20-45 years) and 180 school-age children (SAC) (5-10 years) randomly assigned in a 1:1 ratio to receive either maize flour enriched through agro-biofortification with Se or a control flour not enriched with Se. Households will receive flour (330 g per capita per day) for 12 weeks. The primary outcome is Se concentration in serum (μg/L). Serum will be extracted from venous blood samples drawn at baseline (prior to flour distribution) and end-line. Selenium concentration will be measured by using inductively coupled plasma mass spectrometry.
DISCUSSION


Findings will be communicated to policy stakeholders and participating communities and reported in peer-reviewed journals.
TRIAL REGISTRATION


The Addressing Hidden Hunger with Agronomy (Malawi) trial is registered (5 th  March 2019; ISCRTN85899451).",2019,Concentrations of Se in staple cereal crops can be increased through application of Se fertilisers - a process known as agronomic biofortification (agro-biofortification) - and this may contribute to alleviating deficiencies.,"['rural community in Kasungu District, Central Region, Malawi', '180 women of reproductive age (WRA) (20-45\u2009years) and 180 school-age children (SAC) (5-10\u2009years', 'rural Malawi', 'Hidden Hunger with Agronomy (Malawi) trial']",['maize flour enriched through agro-biofortification with Se or a control flour not enriched with Se'],"['Selenium concentration', 'Se concentration in serum (μg/L']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0454907', 'cui_str': 'Central region (geographic location)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1719994', 'cui_str': 'Animal hide'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}]","[{'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C4277687', 'cui_str': 'Biofortification'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",180.0,0.509135,Concentrations of Se in staple cereal crops can be increased through application of Se fertilisers - a process known as agronomic biofortification (agro-biofortification) - and this may contribute to alleviating deficiencies.,"[{'ForeName': 'Edward J M', 'Initials': 'EJM', 'LastName': 'Joy', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. edward.joy@lshtm.ac.uk.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Kalimbira', 'Affiliation': 'Lilongwe University of Agriculture and Natural Resources, PO BOX 219, Bunda College, Lilongwe, Malawi.'}, {'ForeName': 'Dawd', 'Initials': 'D', 'LastName': 'Gashu', 'Affiliation': 'Center for Food Science and Nutrition, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Elaine L', 'Initials': 'EL', 'LastName': 'Ferguson', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Sturgess', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Dangour', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Banda', 'Affiliation': 'Lilongwe University of Agriculture and Natural Resources, PO BOX 219, Bunda College, Lilongwe, Malawi.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Chiutsi-Phiri', 'Affiliation': 'Lilongwe University of Agriculture and Natural Resources, PO BOX 143, Natural Resources College, Lilongwe, Malawi.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Bailey', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Loughborough, LE12 5RD, UK.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Langley-Evans', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Loughborough, LE12 5RD, UK.'}, {'ForeName': 'R Murray', 'Initials': 'RM', 'LastName': 'Lark', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Loughborough, LE12 5RD, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Millar', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Loughborough, LE12 5RD, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Loughborough, LE12 5RD, UK.'}, {'ForeName': 'Limbanazo', 'Initials': 'L', 'LastName': 'Matandika', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mfutso-Bengo', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Phuka', 'Affiliation': 'School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Felix P', 'Initials': 'FP', 'LastName': 'Phiri', 'Affiliation': 'Lilongwe University of Agriculture and Natural Resources, PO BOX 219, Bunda College, Lilongwe, Malawi.'}, {'ForeName': 'Jellita', 'Initials': 'J', 'LastName': 'Gondwe', 'Affiliation': 'Public Health Institute of Malawi, Community Health Sciences Unit, National Nutrition Reference Lab, Lilongwe, Malawi.'}, {'ForeName': 'E Louise', 'Initials': 'EL', 'LastName': 'Ander', 'Affiliation': 'Inorganic Geochemistry, Centre for Environmental Geochemistry, British Geological Survey, Nottingham, NG12 5GG, UK.'}, {'ForeName': 'Nicola M', 'Initials': 'NM', 'LastName': 'Lowe', 'Affiliation': 'UCLan Research Centre for Global Development, University of Central Lancashire, Preston, PR1 2HE, UK.'}, {'ForeName': 'Patson C', 'Initials': 'PC', 'LastName': 'Nalivata', 'Affiliation': 'Lilongwe University of Agriculture and Natural Resources, PO BOX 219, Bunda College, Lilongwe, Malawi.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Broadley', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Loughborough, LE12 5RD, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}]",Trials,['10.1186/s13063-019-3894-2']
732,31566810,Effectiveness of an Avatar application for teaching heart attack recognition and response: A pragmatic randomized control trial.,"AIMS


To evaluate the effectiveness of an Avatar application for educating people with acute coronary syndrome (heart attack).
BACKGROUND


A lack of understanding of Acute Coronary Syndrome symptoms and appropriate responses often contribute to delay in seeking medical treatment.
DESIGN


A single-centre, non-blinded, pragmatic randomized controlled trial.
METHODS


Seventy Acute Coronary Syndrome patients were randomly assigned to the intervention (Avatar application) or usual care groups. Participants were followed up at 0, 1, and 6 months. Tobit Growth Curve Model was used to analyse the primary outcome-symptom knowledge; and the secondary outcomes-attitudes and beliefs. Heart attack action plan implementation and health care utilisation were analysed using Chi-square and Mann-Whitney U test.
RESULTS


Of the 70 participants, 63% were male and the mean age of the participants was 64.7 (SD 11.7) years. Sixty-six (94.2%) participants completed follow-up. Between group differences on acute coronary syndrome (ACS) Response Index scores were statistically significant at 1-month and 6-month follow-ups (p < .01). The intervention group had a significant improvement in symptom knowledge, attitudes, and beliefs over the 6-month period (p < .001, p = .009, p < .001 respectively); and no significant improvement in the usual care group participants (p = .152, p = .068, p = .228). For healthcare use, at follow-up, there was a significant difference in ambulance use, between the intervention group and the usual care group (33.33% vs. 18.18%, p = .008; cardiac: 88.89% vs. 42.86%; p = .049); 85.14% of participants reported that the application helped them to feel more confident in recognizing and responding to symptoms in the future.
CONCLUSION


The education app was effective in improving individuals' ACS knowledge, attitudes, and beliefs. A large multi-centre trial with a longer follow-up to evaluate the intervention's effectiveness on clinical outcomes will be our next step in evaluation.
IMPACT


The content of AVATARS (Nurse Cora) app can be translated into different languages and evaluated for patients from different health settings and linguistic backgrounds.
TRIAL REGISTRATION


This study has been registered with Australian New Zealand Clinical Trials Registry (ANZCTR). The trial registration number is ACTRN12616000803493.",2020,Between group differences on ACS Response Index scores were statistically significant at one-month and six-month follow-ups (p<0.01).,"['educating people with acute coronary syndrome (heart attack', 'Coronary Syndrome patients', 'Of the 70 participants, 63% were male and the mean age of the participants was 64.7 (SD 11.7) years', 'Seventy Acute']","['Avatar application', 'intervention (Avatar application) or usual care groups']","['ACS Response Index scores', 'Symptom Knowledge, Attitudes and Beliefs', ""individuals' ACS knowledge, attitudes and beliefs""]","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",70.0,0.113596,Between group differences on ACS Response Index scores were statistically significant at one-month and six-month follow-ups (p<0.01).,"[{'ForeName': 'Jintana', 'Initials': 'J', 'LastName': 'Tongpeth', 'Affiliation': 'Prachomklao College of Nursing, Praboromrajchanok Institute Ministry of Public Health, Muang, Phetchaburi, Thailand.'}, {'ForeName': 'Huiyun', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'College of Nursing & Health Sciences, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Barry', 'Affiliation': 'College of Nursing & Health Sciences, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Robyn A', 'Initials': 'RA', 'LastName': 'Clark', 'Affiliation': 'College of Nursing & Health Sciences, Flinders University, Adelaide, SA, Australia.'}]",Journal of advanced nursing,['10.1111/jan.14210']
733,21095702,Band-phase-randomized surrogate data reveal high-frequency chaos in heart rate variability.,"We propose a new band-phase-randomized surrogate data method to evaluate the chaotic dynamics in the high (HF) and low frequency (LF) bands of heart rate variability (HRV) in healthy subjects. The chaotic strength of normal HRV as assessed by a noise titration assay completely vanished when its power spectrum was phase-randomized over the entire frequency band or the HF band alone, but not the LF band alone. This finding confirms recent evidence that chaotic dynamics in normal HRV is ascribable mainly to the HF component, or respiratory sinus arrhythmia.",2010,"The chaotic strength of normal HRV as assessed by a noise titration assay completely vanished when its power spectrum was phase-randomized over the entire frequency band or the HF band alone, but not the LF band alone.",['healthy subjects'],[],[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],[],,0.0372025,"The chaotic strength of normal HRV as assessed by a noise titration assay completely vanished when its power spectrum was phase-randomized over the entire frequency band or the HF band alone, but not the LF band alone.","[{'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Harvard-MIT Division of Health Sciences and Technology, Massachusetts Institute of Technology, Cambridge, MA 02139, USA.'}, {'ForeName': 'Guang-Hong', 'Initials': 'GH', 'LastName': 'Ding', 'Affiliation': ''}, {'ForeName': 'Guo-Qiang', 'Initials': 'GQ', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Chi-Sang', 'Initials': 'CS', 'LastName': 'Poon', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2010.5626061']
734,21077522,Evaluation of the feasibility of a new method for performing chorion villus sampling.,"OBJECTIVE


This study aimed to evaluate the usefulness and safety of a new method for taking a placental biopsy.
METHODS


The procedures were performed using the traditional single needle technique (group 1) or the new method (group 2). In group 2, the piston was fixed in a simple metallic clip and the negative pressure was maintained in a continuous manner which was controlled with a three-way stopcock.
RESULTS


Multiple uterine insertion was necessary in 14 cases (32.6%) in group 1 and five (11.9%) in group 2 (p < 0.05). The amount of chorionic tissue obtained was significantly higher in group 2 (19.1 +/- 15.0 mg vs. 33.9 +/- 17.4 mg p < 0.05). The abortion rates did not differ in either group.
CONCLUSION


While using this technique, the operator is capable of performing the procedure without any assistance and of applying constant negative pressure only in the placenta. The advantageous outcomes are probably related to the size as well as the incessant fashion of the vacuum force.",2010,"The abortion rates did not differ in either group.
",[],[],"['amount of chorionic tissue obtained', 'abortion rates']",[],[],"[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}]",,0.0195268,"The abortion rates did not differ in either group.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Buyukkurt', 'Affiliation': 'Departament of Obstetrics & Gynecology, University of Cukurova School of Medicine, Adana, Turkey. selimbuyukkurt@gmail.com'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Seydaoglu', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Demir', 'Affiliation': ''}, {'ForeName': 'F T', 'Initials': 'FT', 'LastName': 'Ozgunen', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Evruke', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Guzel', 'Affiliation': ''}, {'ForeName': 'U K', 'Initials': 'UK', 'LastName': 'Gulec', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Kadayifci', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
735,30776522,Adverse Events in Oral Immunotherapy for the Desensitization of Cow's Milk Allergy in Children: A Randomized Controlled Trial.,"BACKGROUND


This study focuses on the side effects of cow's milk oral immunotherapy (CM-OIT) using consensus definitions of food-induced anaphylaxis.
OBJECTIVE


To evaluate the risk of allergic reactions (ARs) and to identify risk factors associated with higher risk of anaphylactic ARs (AARs) during CM-OIT in children.
METHODS


Clinical charts of children receiving CM-OIT were carefully reviewed. ARs were defined as single-organ ARs, and AARs were defined as involvement of 2 organ systems and/or hypotension in response to CM protein. Descriptive statistics were used to represent demographics, occurrence, reaction characteristics, and comorbidities. Poisson analysis was performed to evaluate risk factors associated with AARs.
RESULTS


Among 41 children undergoing CM-OIT, 11 discontinued the treatment (N = 26.8%). The mean age at challenge was 12.1 years (standard deviation [SD], 3.6) and half were male (56.1%). The mean number of AARs per patient was 6.0 (SD, 3.5) versus a mean of 17.4 (SD, 11.9) non-AARs per patient. Among withdrawals from OIT, the mean number of AARs per patient was 8.3 versus 5.1 in nonwithdrawals. AARs were more frequent in children with higher specific IgE (sIgE) for α-lactalbumine and casein at baseline (1.11 [95% confidence interval (CI): 1.01, 1.22] and 1.01 [1.0, 1.03], respectively). Children with resolved eczema and higher sIgE for β-lactoglobuline at baseline (0.13 [95% CI: 0.04, 0.46] and 0.96 [95% CI: 0.94, 0.99], respectively) were less likely to develop AARs.
CONCLUSIONS


Although the majority of ARs during OIT are nonanaphylactic, AARs occur frequently. Children with higher sIgE for α-lactalbumine and casein at baseline seem to be at higher risk for AARs during OIT.",2019,"AARs were more frequent in children with higher specific IgE (sIgE) for α-lactalbumine and casein at baseline (1.11 [95% confidence interval (CI): 1.01, 1.22] and 1.01 [1.0, 1.03], respectively).","[""Cow's Milk Allergy in Children"", 'children', 'Clinical charts of children receiving CM-OIT were carefully reviewed', 'The mean age at challenge was 12.1 years (standard deviation [SD], 3.6) and half were male (56.1', 'Children with resolved eczema and higher sIgE for β-lactoglobuline at baseline (0.13', '41 children undergoing CM-OIT, 11 discontinued the treatment (N\xa0= 26.8']","['Oral Immunotherapy', ""cow's milk oral immunotherapy (CM-OIT""]","['risk of allergic reactions (ARs', 'mean number of AARs']","[{'cui': 'C0266815', 'cui_str': ""Cow's milk protein sensitivity (disorder)""}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3714811', 'cui_str': 'Resolved (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4517428', 'cui_str': '0.13 (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk (substance)""}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",41.0,0.183694,"AARs were more frequent in children with higher specific IgE (sIgE) for α-lactalbumine and casein at baseline (1.11 [95% confidence interval (CI): 1.01, 1.22] and 1.01 [1.0, 1.03], respectively).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'De Schryver', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, McGill University, Montreal, QC, Canada. Electronic address: sarah.deschryver@yahoo.com.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Mazer', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Clarke', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Yvan', 'Initials': 'Y', 'LastName': 'St Pierre', 'Affiliation': 'Division of Clinical Epidemiology, Department of Medicine, McGill University Health Center, Montreal, QC, Canada.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Lejtenyi', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Langlois', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Torabi', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Wei W', 'Initials': 'WW', 'LastName': 'Zhao', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Edmond S', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Baerg', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Ben-Shoshan', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, McGill University, Montreal, QC, Canada.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.02.007']
736,30130627,"Effects of Alfuzosin, an α 1 -Adrenergic Antagonist, on Anal Pressures and Bowel Habits in Women With and Without Defecatory Disorders.","BACKGROUND & AIMS


Some patients with defecatory disorders (DD) have high anal pressures that may impede rectal evacuation. Alpha-1 adrenoreceptors mediate as much as 50% of anal resting pressure in humans. We performed a randomized, placebo-controlled study of the effects of alfuzosin, an alpha1-adrenergic receptor antagonist, on anal pressures alone in healthy women and also on bowel symptoms in women with DD.
METHODS


In a double-blind study performed from March 2013 through March 2017, anal pressures were evaluated before and after 36 women with DD (constipation for at least 1 year) and 36 healthy women (controls) were randomly assigned (1:1) to groups given oral alfuzosin (2.5 mg immediate release) or placebo. Thereafter, patients were randomly assigned (1:1) to groups given oral alfuzosin (10 mg extended release) or placebo each day for 2 weeks. Participants kept daily diaries of bowel symptoms for 2 weeks before (baseline) and during administration of the test articles (treatment). Weekly questionnaires recorded the overall severity of constipation symptoms, bloating, abdominal pain, nausea, and vomiting; overall satisfaction with treatment of constipation was evaluated at weeks 2 and 4. The primary endpoint was the change in the number of spontaneous (SBMs) and complete SBMs (CSBMs) between the treatment and baseline periods. We evaluated relationships between stool form, passage, and complete evacuation.
RESULTS


Alfuzosin reduced anal resting pressure by 32 ± 3 mm Hg versus 16 ± 3 mm Hg for placebo (P = .0001) and anal pressure during evacuation by 26 ± 3 mm Hg versus 16 ± 3 mm Hg for placebo, (P = .03). However, alfuzosin did not significantly increase the rectoanal gradient, SBMs or CSBMs compared with placebo. Both formulations of alfuzosin were well tolerated. Hard stools and the ease of passage during defecation accounted for 72% and 76% of the variance in the satisfaction after defecation, respectively, during baseline and treatment periods.
CONCLUSIONS


In a randomized trial, alfuzosin reduced anal pressure at rest and during simulated evacuation in healthy and constipated women, compared with placebo, but did not improve bowel symptoms in constipated women. This could be because the drug does not improve stool form or dyssynergia, which also contribute to DD. ClinicalTrials.gov number, NCT 01834729.",2019,"RESULTS


Alfuzosin reduced anal resting pressure by 32 ± 3 mm Hg versus 16 ± 3 mm Hg for placebo (P = .0001) and anal pressure during evacuation by 26 ± 3 mm Hg versus 16 ± 3 mm Hg for placebo, (P = .03).","['patients with defecatory disorders (DD', 'healthy and constipated women', 'Women', 'healthy women and also on bowel symptoms in women with DD', '36 women with DD (constipation for at least 1 year) and 36 healthy women (controls']","['alfuzosin', 'oral alfuzosin', 'Alfuzosin', 'placebo']","['rectoanal gradient, SBMs or CSBMs', 'overall severity of constipation symptoms, bloating, abdominal pain, nausea, and vomiting; overall satisfaction with treatment of constipation', 'tolerated', 'change in the number of spontaneous (SBMs) and complete SBMs (CSBMs', 'Anal Pressures and Bowel Habits', 'bowel symptoms', 'anal pressure', 'Hard stools and the ease of passage during defecation', 'anal resting pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0051150', 'cui_str': 'alfuzosin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0278016', 'cui_str': 'Hard stool (finding)'}]",,0.75681,"RESULTS


Alfuzosin reduced anal resting pressure by 32 ± 3 mm Hg versus 16 ± 3 mm Hg for placebo (P = .0001) and anal pressure during evacuation by 26 ± 3 mm Hg versus 16 ± 3 mm Hg for placebo, (P = .03).","[{'ForeName': 'Subhankar', 'Initials': 'S', 'LastName': 'Chakraborty', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Feuerhak', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anjani', 'Initials': 'A', 'LastName': 'Muthyala', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harmsen', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kent R', 'Initials': 'KR', 'LastName': 'Bailey', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Adil E', 'Initials': 'AE', 'LastName': 'Bharucha', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address: bharucha.adil@mayo.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.08.036']
737,31560945,"Transcranial direct current stimulation (tDCS) for post-traumatic stress disorder (PTSD): A randomized, double-blinded, controlled trial.","Currently, there is not definitive information regarding the efficacy of transcranial direct current stimulation (tDCS) for Post-traumatic stress disorder (PTSD). This study aimed to examine the efficacy of tDCS for PTSD and its sub-symptoms. In a double-blind, controlled randomized clinical trial, 40 participants with PTSD were randomly assigned to receive either 10 tDCS sessions delivered at 2 mA to the right (cathode) and left (anode) dorsolateral prefrontal cortex (DLPFC) or 10 sham tDCS sessions to the same area. A blinded rater assessed PTSD, depressive, and anxiety symptoms before treatment, following it, and after a 1-month follow-up period. According to the results: i) PTSD patients demonstrated a significant reduction in PTSD symptoms, hyper-arousal and negative alterations in cognition and mood sub-symptoms as well as depressive and anxiety symptoms in the active stimulation compared to the sham stimulation at post-treatment and follow-up; ii) active stimulation when compared to sham stimulation revealed greater reductions in re-experiencing sub-symptoms from baseline to post-test. However, follow-up differences did not reach significance; iii) With respect to avoidance sub-symptoms, there were no significant differences between the active and sham stimulation at post-test and follow-up. This study supported the efficacy of 10 sessions of bilateral DLPFC tCDS delivered at 2 mA for the treatment of PTSD symptoms. Taken together, these findings suggest that although tDCS can reduce PTSD symptoms, researchers should consider the different types of PTSD and use strategies to ensure sufficient power to detect a potential effect of tDCS on various types of PTSD.",2019,"With respect to avoidance sub-symptoms, there were no significant differences between the active and sham stimulation at post-test and follow-up.","['post-traumatic stress disorder (PTSD', '40 participants with PTSD']","['tDCS', 'bilateral DLPFC tCDS', 'Transcranial direct current stimulation (tDCS', 'transcranial direct current stimulation (tDCS', '10 tDCS sessions delivered at 2\u2009mA to the right (cathode) and left (anode) dorsolateral prefrontal cortex (DLPFC) or 10 sham tDCS sessions']","['PTSD symptoms, hyper-arousal and negative alterations in cognition and mood sub-symptoms as well as depressive and anxiety symptoms', 'PTSD, depressive, and anxiety symptoms']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0546911', 'cui_str': 'To the right (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",40.0,0.136097,"With respect to avoidance sub-symptoms, there were no significant differences between the active and sham stimulation at post-test and follow-up.","[{'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Ahmadizadeh', 'Affiliation': 'Behavioral Science Research Center, Life Style Institute, Baqiyatallah University of Medical Science, Tehran, Iran. Electronic address: mjahmadizadeh@yahoo.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Behavioral Science Research Center, Life Style Institute, Baqiyatallah University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, The Epworth Clinic, Camberwell, Victoria, Australia, 3124 and Monash University Central Clinical School, Commercial Rd, Melbourne, Victoria, Australia.'}]",Brain research bulletin,['10.1016/j.brainresbull.2019.09.011']
738,31694576,"Induction techniques that reduce redistribution hypothermia: a prospective, randomized, controlled, single blind effectiveness study.","BACKGROUND


While much effort has been devoted to correcting intraoperative hypothermia, less attention has been directed to preventing redistribution hypothermia. In this study, we compared three different anesthetic induction techniques to standard IV propofol inductions (control) in their effect on reducing redistribution hypothermia.
METHODS


Elective, afebrile patients, age 18 to 55 years, were randomly assigned to one of four groups (n = 50 each). Group ""INH/100"" was induced with 8% sevoflurane in 100% oxygen, Group ""INH/50"" with 8% sevoflurane in 50% oxygen and 50% nitrous oxide, Group ""PROP"" with 2.2 mg/kg propofol, and Group ""Phnl/PROP"" with 2.2 mg/kg propofol immediately preceded by 160 mcg phenylephrine. Patients were maintained with sevoflurane in 50% nitrous oxide and 50% oxygen in addition to opioid narcotic. Forced air warming was used. Core temperatures were recorded every 15 min after induction for 1 h.
RESULTS


Compared to control group PROP, the mean temperatures in groups INH/100, INH/50, and Phnl/PROP were higher 15, 30, 45 and 60 min after induction (p < 0.001 for all comparisons), averaging between 0.39 °C and 0.54 °C higher. In group PROP, 60% of patients had at least one temperature below 36.0 °C in the first hour whereas only 16% did in each of groups INH/100, INH/50, and Phnl/PROP (p < 0.0001 in each group compared to PROP).
CONCLUSIONS


In this effectiveness trial, inhalation inductions with sevoflurane or with prophylactic phenylephrine bolus prior to propofol induction reduced the magnitude of redistribution hypothermia by an average of 0.4 to 0.5 °C in patients aged 18 to 55 years.
TRIAL REGISTRATION


Retrospectively registered on clinical-trials.gov as NCT02331108 , November 20, 2014.",2019,"Core temperatures were recorded every 15 min after induction for 1 h.
RESULTS


Compared to control group PROP, the mean temperatures in groups INH/100, INH/50, and Phnl/PROP were higher 15, 30, 45 and 60 min after induction (p < 0.001 for all comparisons), averaging between 0.39 °C and 0.54 °C higher.","['Elective, afebrile patients, age 18 to 55\u2009years', 'patients aged 18 to 55\u2009years']","['nitrous oxide and 50% oxygen in addition to opioid narcotic', 'phenylephrine', 'prophylactic phenylephrine', 'sevoflurane', 'standard IV propofol inductions (control', 'sevoflurane in 50% oxygen and 50% nitrous oxide, Group ""PROP"" with 2.2\u2009mg/kg propofol, and Group ""Phnl/PROP"" with 2.2\u2009mg/kg propofol']","['redistribution hypothermia', 'Core temperatures']","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0277797', 'cui_str': 'Apyrexial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0332620', 'cui_str': 'Redistribution (finding)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",,0.0624361,"Core temperatures were recorded every 15 min after induction for 1 h.
RESULTS


Compared to control group PROP, the mean temperatures in groups INH/100, INH/50, and Phnl/PROP were higher 15, 30, 45 and 60 min after induction (p < 0.001 for all comparisons), averaging between 0.39 °C and 0.54 °C higher.","[{'ForeName': 'Jonathan V', 'Initials': 'JV', 'LastName': 'Roth', 'Affiliation': 'Department of Anesthesiology, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA, USA. jvroth1@aol.com.'}, {'ForeName': 'Leonard E', 'Initials': 'LE', 'LastName': 'Braitman', 'Affiliation': 'Office for Research and Technology Development, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA, USA.'}, {'ForeName': 'Lacy H', 'Initials': 'LH', 'LastName': 'Hunt', 'Affiliation': 'Office for Research and Technology Development, Albert Einstein Medical Center, 5501 Old York Road, Philadelphia, PA, USA.'}]",BMC anesthesiology,['10.1186/s12871-019-0866-8']
739,30720503,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","MINI: Question: Is the Fundamentals of Robotic Surgery (FRS) proficiency-based progression curriculum effective for teaching basic robotic surgery skills?
FINDINGS


In an international multi-institutional, multispecialty, blinded, randomized control trial, implementation of the FRS skills curriculum using various simulation platforms led to improved performance of surgical trainees on a transfer test compared with controls.Meaning: The FRS is an effective simulation-based course for training to proficiency on basic robotic surgery skills before surgeons apply those skills clinically.
OBJECTIVE


To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA


There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS


Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS


All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS


We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2019,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['FRS) Skills Curriculum', 'Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', '12 international American College of Surgeons (ACS']","['MINI', 'Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula', 'FRS', 'dV-Trainer']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010478', 'cui_str': 'Curriculum'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.168174,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
740,31900620,The impact of the caregiver-oncologist relationship on caregiver experiences of end-of-life care and bereavement outcomes.,"PURPOSE


The quality of the relationship between oncologists and cancer patients has been associated with caregiver bereavement outcomes, but no studies have examined whether the perceived quality of the relationship between cancer caregivers and oncologists is associated with caregiver experiences of end-of-life care or psychological adjustment after the patient's death.
METHODS


We conducted secondary analyses of data collected in the Values and Options in Cancer Care (VOICE) study, a randomized controlled trial of an intervention that improved communication between oncologists and patients/caregivers (n = 204 dyads). At study entry, we assessed caregivers' experiences with the oncologist using four items from the Human Connection Scale. Following patients' deaths, we assessed bereaved caregivers' experiences with end-of-life cancer care (Quality of Death; Peace, Equanimity, and Acceptance in the Cancer Experience [PEACE]; Caregiver Evaluation of the Quality of End-of-Life Care [CEQUEL]; and modified Decision Regret scales) and psychological adjustment (Prolonged Grief Disorder-13 and Purpose in Life scales). We conducted multivariable regressions examining prospective associations between caregiver experiences with the oncologist at study entry and outcome variables.
RESULTS


Data were collected from 105 caregivers of patients who died during the course of the study. Positive experience with the oncologist was prospectively associated with better experiences of end-of-life care, as reflected in better quality of death (estimate = 0.33, SE = 0.14, p = 0.02), PEACE (estimate = 0.11, SE = 0.05, p = 0.04), and decisional regret (estimate = - 0.16, SE = 0.06, p = 0.01). Caregivers' experience with the oncologist was not significantly associated with indicators of psychological adjustment.
CONCLUSION


Caregivers' early experiences with oncologists may affect their experiences of the patient's end-of-life care.",2020,"Caregivers' experience with the oncologist was not significantly associated with indicators of psychological adjustment.
","['oncologists and patients/caregivers (n = 204 dyads', '105 caregivers of patients who died during the course of the study']",[],"['decisional regret', 'quality of death', ""bereaved caregivers' experiences with end-of-life cancer care (Quality of Death; Peace, Equanimity, and Acceptance in the Cancer Experience [PEACE]; Caregiver Evaluation of the Quality of End-of-Life Care [CEQUEL]; and modified Decision Regret scales) and psychological adjustment (Prolonged Grief Disorder-13 and Purpose in Life scales""]","[{'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0039548', 'cui_str': 'End of Life Care'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0557904', 'cui_str': 'Psychological Adjustment'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder (finding)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]",204.0,0.11253,"Caregivers' experience with the oncologist was not significantly associated with indicators of psychological adjustment.
","[{'ForeName': 'Amy W', 'Initials': 'AW', 'LastName': 'An', 'Affiliation': 'Department of Medicine, Division of Palliative Care, University of Rochester Medical Center, 601 Elmwood Ave, Box 687, Rochester, NY, 14642, USA. amy_an@urmc.rochester.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ladwig', 'Affiliation': 'Department of Medicine, Division of Palliative Care, University of Rochester Medical Center, 601 Elmwood Ave, Box 687, Rochester, NY, 14642, USA.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Department of Medicine, Division of Palliative Care, University of Rochester Medical Center, 601 Elmwood Ave, Box 687, Rochester, NY, 14642, USA.'}, {'ForeName': 'Holly G', 'Initials': 'HG', 'LastName': 'Prigerson', 'Affiliation': 'Department of Medicine, Division of Geriatrics and Palliative Medicine, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, Piscataway, New Jersey, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05185-2']
741,30664277,Preservation of Denonvilliers' fascia for nerve-sparing laparoscopic total mesorectal excision: A neuro-histological study.,"Urogenital complications due to pelvic autonomic nerve damage frequently occur following rectal surgery. We investigated whether total mesorectal excision (TME) with preservation of the Denonvilliers' fascia (DVF) can effectively prevent the removal of pelvic autonomic nerves through microscopy. Twenty consecutive male patients with mid-low rectal cancer who received TME with preservation or resection of the Denonvilliers' fascia (P and R groups, respectively) were included. Serial transverse sections from surgical specimens were studied histologically. Nerve fibers at the surfaces of the mesorectum were counted. Clinical correlation between the amount of nerve fibers removed and post-operative sexual function was analyzed. Nerve fibers closely localized to the DVF in the R group displaying rich erectile activity (positive anti-nNOS immunostaining). At the anterior surface of the mesorectum, the mean numbers of nNOS-positive nerve fibers per specimen in the P group were significantly lower than the R group (3.0 ± 1.8 vs. 5.0 ± 2.3, P < 0.05). Compared to the R group, patients in the P group had higher IIEF scores and better erectile function at 3 and 6 months post-operatively. The DVF is a key risk zone for pelvic denervation during laparoscopic TME. Preservation of the DVF can prevent the removal of autonomic nerves and protect post-operative erectile function. Clin. Anat. 32:439-445, 2019. © 2019 Wiley Periodicals, Inc.",2019,Nerve fibers closely localized to the DVF in the R group displaying rich erectile activity (positive anti-nNOS immunostaining).,"[""Twenty consecutive male patients with mid-low rectal cancer who received TME with preservation or resection of the Denonvilliers' fascia (P and R groups, respectively) were included"", '2019']","[""Denonvilliers' fascia for nerve-sparing laparoscopic total mesorectal excision"", 'DVF', ""total mesorectal excision (TME) with preservation of the Denonvilliers' fascia (DVF"", 'rectal surgery']","['mean numbers of nNOS-positive nerve fibers per specimen', 'IIEF scores', 'erectile function']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027749', 'cui_str': 'Nerve Fibers'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",20.0,0.0351597,Nerve fibers closely localized to the DVF in the R group displaying rich erectile activity (positive anti-nNOS immunostaining).,"[{'ForeName': 'Jianpei', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Pinjie', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Liang', 'Affiliation': 'Department of Pathology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zongheng', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastrointestinal Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Department of Gastrointestinal Surgery, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}]","Clinical anatomy (New York, N.Y.)",['10.1002/ca.23336']
742,31690089,Moderators of the effect of guided online self-help for people with HIV and depressive symptoms.,"The goal of the study was to investigate moderators of intervention effect of a guided Internet-based self-help cognitive behavioral intervention for people with HIV and depressive symptoms. This study was part of a randomized controlled trial where the intervention was found to be effective in reducing depressive symptoms, compared to an attention-only control group. Demographic characteristics (e.g., age), HIV characteristics (e.g., duration of HIV), and psychological characteristics (e.g., coping self-efficacy) were investigated as potential moderators of intervention effect. In 2015, 188 people with HIV and depressive symptoms were included in the study: 97 were randomized to the intervention group and 91 to the control group. Two moderators of intervention effect were found: coping self-efficacy and baseline depression severity. Participants with low coping self-efficacy and baseline depression severity improved more in the intervention group than in the control group, and participants with high coping self-efficacy and baseline depression severity improved in both groups. The results indicate that the intervention may be provided to all people with HIV and depressive symptoms. It may be especially important for people with HIV and low coping self-efficacy to start with the intervention since they show less improvement in the control group with only attention.  Trial registration:  Nederlands Trialregister NTR5407, September 11, 2015.",2020,"Participants with low coping self-efficacy and baseline depression severity improved more in the intervention group than in the control group, and participants with high coping self-efficacy and baseline depression severity improved in both groups.","['188 people with HIV and depressive symptoms were included in the study: 97', 'people with HIV and depressive symptoms']","['guided Internet-based self-help cognitive behavioral intervention', 'guided online self-help']","['low coping self-efficacy and baseline depression severity', 'depressive symptoms', 'Demographic characteristics (e.g., age), HIV characteristics (e.g., duration of HIV), and psychological characteristics (e.g., coping self-efficacy', 'high coping self-efficacy and baseline depression severity', 'coping self-efficacy and baseline depression severity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",97.0,0.0692081,"Participants with low coping self-efficacy and baseline depression severity improved more in the intervention group than in the control group, and participants with high coping self-efficacy and baseline depression severity improved in both groups.","[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'van Luenen', 'Affiliation': 'Institute of Psychology, Section of Clinical Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Kraaij', 'Affiliation': 'Institute of Psychology, Section of Clinical Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Spinhoven', 'Affiliation': 'Institute of Psychology, Section of Clinical Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Dusseldorp', 'Affiliation': 'Institute of Psychology, Section of Methodology and Statistics, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Garnefski', 'Affiliation': 'Institute of Psychology, Section of Clinical Psychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, Netherlands.'}]",AIDS care,['10.1080/09540121.2019.1679703']
743,31629764,Perceptual responses to continuous versus intermittent blood flow restriction exercise: A randomized controlled trial.,"We investigated the perceptual responses to resistance exercise (RE) with continuous and intermittent blood flow restriction (BFR). Fourteen males randomly completed the following exercise conditions: low-load RE with continuous BFR (cBFR), low-load RE with intermittent BFR (iBFR), low-load RE without BFR (LI), and traditional high-load RE (HI). Participants completed 4 sets of 30-15-15-15 repetitions of bilateral leg press and knee extension exercises during the low-load conditions, at 20% of one-repetition maximum (1-RM), a 1.5‑sec metronome-controlled pace, with a 1-min rest interval between sets; HI consisted of 4 sets of 10 repetitions of the same exercises, at 70% 1-RM, with the same pace and rest interval. Ratings of perceived exertion (RPE) and discomfort were assessed using psychometric scales before exercise and after each set. RPE displayed no significant differences (p > 0.05) between the BFR conditions for either exercise. Additionally, both BFR conditions elicited significantly (p < 0.05) greater RPE than LI and significantly (p <0.05) lower RPE than HI during both exercises. Rating of discomfort displayed no significant differences between BFR conditions during the first two sets of leg press; however, cBFR evoked greater discomfort compared to iBFR during the last two sets. There were no significant (p > 0.05) differences observed between conditions during the knee extension exercise. Rating of discomfort was similar between the BFR and HI conditions and each were significantly greater than LI during both exercises. Therefore, cBFR and iBFR seem to produce similar perceptual responses, which are greater than LI and lower than HI, but similar in regards to discomfort.",2019,"Additionally, both BFR conditions elicited significantly (p<0.05) greater RPE than LI and significantly (p<0.05) lower RPE than HI during both exercises.",['Fourteen males randomly completed the following'],"['resistance exercise (RE) with continuous and intermittent blood flow restriction (BFR', 'exercise conditions: low-load RE with continuous BFR (cBFR), low-load RE with intermittent BFR (iBFR), low-load RE without BFR (LI), and traditional high-load RE (HI', 'bilateral leg press and knee extension exercises']","['Rating of discomfort', 'Ratings of perceived exertion (RPE) and discomfort', 'BFR conditions']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.0359438,"Additionally, both BFR conditions elicited significantly (p<0.05) greater RPE than LI and significantly (p<0.05) lower RPE than HI during both exercises.","[{'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, OK, USA. Electronic address: eduardofreitas@ou.edu.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, OK, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, OK, USA.'}, {'ForeName': 'Rodrigo R', 'Initials': 'RR', 'LastName': 'Aniceto', 'Affiliation': 'Department of Physical Education, Kinanthropometry and Human Performance Laboratory, Federal University of Paraíba, João Pessoa, PB, Brazil.'}, {'ForeName': 'Julio G C', 'Initials': 'JGC', 'LastName': 'Silva', 'Affiliation': 'Study and Research Group in Biomechanics and Psychophysiology of Exercise, Federal Institute of Education, Science and Technology of Rio Grande do Norte, Currais Novos, RN, Brazil.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, OK, USA.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112717']
744,30502505,Lusutrombopag Reduces Need for Platelet Transfusion in Patients With Thrombocytopenia Undergoing Invasive Procedures.,"BACKGROUND & AIMS


Platelet transfusion is used to prevent hemorrhagic events in patients with thrombocytopenia undergoing invasive procedures, but there are many disadvantages. We evaluated the efficacy and safety of lusutrombopag in patients with chronic liver disease and thrombocytopenia undergoing invasive procedures.
METHODS


We performed a double-blind, parallel-group, phase 3 study of 96 patients with chronic liver disease and thrombocytopenia (platelet counts below 50,000/μL) undergoing invasive procedures from October 2013 to May 2014 at 81 centers in Japan. Patients were randomly assigned (1:1) to groups given once-daily lusutrombopag (3 mg) or placebo for up to 7 days. The primary efficacy endpoint was the proportion of patients not requiring platelet transfusion before the invasive procedure. The protocol-defined response (platelet count 50,000/μL or more with an increase of 20,000/μL or more from baseline) and the time course of the change in platelet count were also evaluated. Adverse events were recorded.
RESULTS


The proportions of patients who did not require preoperative platelet transfusion were 79.2% (38/48) in the lusutrombopag group and 12.5% (6/48) in the placebo group (P < .0001). A response was observed in 77.1% (37/48) of patients in the lusutrombopag group and 6.3% (3/48) of patients in the placebo group (P < .0001). In the lusutrombopag group without platelet transfusion, the median platelet count was 50,000/μL or more after 5 days; the mean time to reach the maximum platelet count was 13.4 days; and the number of days (adjusted mean) during which the platelet count was 50,000/μL or more was 21.09 days. Adverse drug reactions were reported in 8.3% of patients in the lusutrombopag group and 2.1% of patients in the placebo group. Two patients (1 per group) had a thrombotic event, but neither were associated with an excessive increase in platelet count (200,000/μL or more).
CONCLUSION


In a placebo-controlled trial, lusutrombopag was effective in achieving and maintaining the target platelet count in patients with chronic liver disease and thrombocytopenia undergoing invasive procedures. No significant safety concerns were raised. Japanese clinical trial registration no: JapicCTI-132323.",2019,A response was observed in 77.1% (37/48) of patients in the lusutrombopag group and 6.3% (3/48) of patients in the placebo group (P < .0001).,"['96 patients with chronic liver disease and thrombocytopenia (platelet counts below 50,000/μL) undergoing invasive procedures from October 2013 to May 2014 at 81 centers in Japan', 'patients with thrombocytopenia undergoing invasive procedures', 'patients with chronic liver disease and thrombocytopenia undergoing invasive procedures', 'Patients With Thrombocytopenia Undergoing Invasive Procedures']","['lusutrombopag', 'Lusutrombopag', 'placebo']","['Adverse drug reactions', 'Adverse events', 'median platelet count', 'thrombotic event', 'mean time to reach the maximum platelet count', 'efficacy and safety', 'platelet count', 'proportion of patients not requiring platelet transfusion', 'preoperative platelet transfusion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C4309207', 'cui_str': 'lusutrombopag'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",96.0,0.195116,A response was observed in 77.1% (37/48) of patients in the lusutrombopag group and 6.3% (3/48) of patients in the placebo group (P < .0001).,"[{'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Hidaka', 'Affiliation': 'Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Sagamihara, Japan. Electronic address: hisashi7@kitasato-u.ac.jp.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kurosaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Japanese Red Cross Society Musashino Hospital, Musashino, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Internal Medicine, Hyogo College of Medicine Hospital, Nishinomiya, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan.'}, {'ForeName': 'Seigo', 'Initials': 'S', 'LastName': 'Abiru', 'Affiliation': 'Department of Hepatology, National Hospital Organization Nagasaki Medical Center, Omura, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Igura', 'Affiliation': 'Department of Gastroenterology, Ikeda Municipal Hospital, Ikeda, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Saiseikai Niigata Daini Hospital, Niigata, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Seike', 'Affiliation': 'Department of Gastroenterology, Oita University Hospital, Yufu, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Katsube', 'Affiliation': 'Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Ochiai', 'Affiliation': 'Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuhara', 'Affiliation': 'Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kano', 'Affiliation': 'Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Tsutae', 'Initials': 'T', 'LastName': 'Nagata', 'Affiliation': 'Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Katsuaki', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Mineo', 'Initials': 'M', 'LastName': 'Kurokawa', 'Affiliation': 'Department of Hematology and Oncology, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Internal Medicine, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Osaki', 'Affiliation': 'Japanese Red Cross Society Osaka Hospital, Osaka, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Japanese Red Cross Society Musashino Hospital, Musashino, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Imawari', 'Affiliation': 'Institute for Gastrointestinal and Liver Diseases, Shin-yurigaoka General Hospital, Kawasaki, Japan.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.11.047']
745,30441289,An Automatic Cycling Performance Classifier System Based on the Crank Arm Force Measurement Data.,"This paper describes the development of an automatic cycling performance measurement system with a Fuzzy Logic Controller (FLC), using Mamdani Inference method, to classify the performance of the cyclist. From data of the average power, its standard deviation and the effective force bilateral asymmetry index, a score that represents the cyclist performance is determined. Data are acquired using an experimental crank arm load cell force platform developed with built-in strain gages and conditioning circuit that measure the force that is applied to the bicycle pedal during cycling with a linearity error under 0.6%. A randomized block experiment design was performed with 15 cyclists of 29±5 years with a body mass of 73±9kg and a height of 1.78±0.07m. The average power reached by the subjects was 137.63±59.6W; the mean bilateral asymmetry index, considering all trials, was 67.01±6.23%. The volunteers cycling performance scores were then determined using the developed FLC; the mean score was 25.4% ± 16.9%. ANOVA showed that the subject causes significant variation on the performance score.",2018,"The average power reached by the subjects was 137.63±59.6W; the mean bilateral asymmetry index, considering all trials, was 67.01±6.23%.",['15 cyclists of 29±5 years with a body mass of 73±9kg and a height of 1.78±0.07m'],['Fuzzy Logic Controller (FLC'],"['volunteers cycling performance scores', 'performance score', 'average power']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0162586', 'cui_str': 'Fuzzy Logic'}]","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0308227,"The average power reached by the subjects was 137.63±59.6W; the mean bilateral asymmetry index, considering all trials, was 67.01±6.23%.","[{'ForeName': 'Andre Vieira', 'Initials': 'AV', 'LastName': 'Pigatto', 'Affiliation': ''}, {'ForeName': 'Raphael Ruschel Dos', 'Initials': 'RRD', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Balbinot', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2018.8513403']
746,32407947,"Intralymphatic immunotherapy for mountain cedar pollinosis: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Allergen immunotherapy can provide long-term benefits, including symptomatic relief and reduced disease progression, but it requires a lengthy regimen that presents barriers to patient adherence. Thus, there is a need for improved approaches to immunotherapy. Recently, several clinical trials have reported successful results from intralymphatic immunotherapy.
OBJECTIVE


To evaluate the efficacy, safety, and tolerability of intralymphatic immunotherapy for allergies caused by mountain cedar pollen in a proof-of-concept study.
METHODS


A total of 21 patients with allergic rhinoconjunctivitis because of mountain cedar pollen were randomized to receive 3 monthly intralymphatic injections of allergenic extract or placebo before the 2018-2019 mountain cedar pollen season. Safety was monitored during treatment to the end of the pollen season using structured and spontaneous reports. Clinical efficacy information was collected using a daily electronic diary of symptoms and allergy medication. Allergen-specific serum immunoglobulin E was assessed before treatment and at the end of the study.
RESULTS


There were no serious adverse events or systemic reactions in either group. A total of 4 patients experienced mild injection-site reactions. Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (P < .001), and the active treatment group had lower average total combined scores on 20 of 27 days during the peak pollen season (P < .05). There was no significant difference among groups in changes to mean mountain cedar-specific serum immunoglobulin E levels.
CONCLUSION


In this proof-of-concept trial, intralymphatic immunotherapy was well tolerated and improved the symptoms and medication use associated with allergic rhinoconjunctivitis caused by mountain cedar pollen.
TRIAL REGISTRATION


This study was registered at ClinicalTrials.gov under the registration number NCT03682965 before the enrollment of the first subject.",2020,Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (p < 0.001) and the active treatment group had lower average total combined scores on 20 of 27 days during peak pollen season (p < 0.05).,"['mountain cedar pollinosis', 'prior to the 2018-2019 mountain cedar pollen season', 'Twenty-one patients with allergic rhinoconjunctivitis due to mountain cedar pollen']","['allergenic extract or placebo', 'intralymphatic immunotherapy', 'Intralymphatic immunotherapy', 'placebo']","['Safety', 'allergy symptoms and medication use relative', 'serious adverse events or systemic reactions', 'efficacy, safety and tolerability', 'mild injection-site reactions', 'mean mountain cedar-specific serum IgE levels', 'average total combined scores']","[{'cui': 'C0330154', 'cui_str': 'Juniperus mexicana'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0440386', 'cui_str': 'Mountain cedar pollen'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0440016', 'cui_str': 'Allergenic extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1512956', 'cui_str': 'Intralymphatic route'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0330154', 'cui_str': 'Juniperus mexicana'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",21.0,0.239599,Patients receiving intralymphatic immunotherapy experienced a significant improvement in allergy symptoms and medication use relative to patients receiving placebo (p < 0.001) and the active treatment group had lower average total combined scores on 20 of 27 days during peak pollen season (p < 0.05).,"[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Thompson', 'Affiliation': 'Aspire Allergy & Sinus, Austin, Texas.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Silvers', 'Affiliation': 'Aspire Allergy & Sinus, Austin, Texas.'}, {'ForeName': 'Mark Adam', 'Initials': 'MA', 'LastName': 'Shapiro', 'Affiliation': 'Pharma Initiatives Consulting, Chapel Hill, North Carolina. Electronic address: mshapiro@pharmainitiatives.com.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.04.030']
747,32407901,A novel extended prophylactic antibiotic regimen in preterm pre-labor rupture of membranes: A randomized trial.,"OBJECTIVES


Prophylactic antibiotic use in preterm pre-labor rupture of membranes (PPROM) is associated with a significant reduction in intra-amniotic infection and improved neonatal outcome. However, data is insufficient to determine the optimal antibiotic regimen. Considering the rise in Escherichia coli and Klebsiella pneumonia early-onset sepsis rate and the emergence of ampicillin resistance, our aim is to compare the efficiency of two antibiotic regimens in prolonging pregnancy and reducing infectious morbidity.
DESIGN


This multicenter randomized unblinded controlled prospective trial compared two antibiotic prophylactic protocols in PPROM: ampicillin + roxithromycin vs. cefuroxime + roxithromycin in 84 women with PPROM, from 12/2015-12/2019.
RESULTS


The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days). Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation, were similar between the groups. K. pneumonia cultures were significantly more frequent in the ampicillin + roxithromycin group. None of the cultures were group B Streptococcus positive.
CONCLUSIONS


To prolong latency period and reduce gram-negative early-onset sepsis, cefuroxime + roxithromycin is recommended as the first-line protocol in PPROM.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02819570.",2020,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"['preterm pre-labor rupture of membranes', 'PPROM', '84 women with PPROM, from 12/2015-12/2019', 'preterm pre-labor rupture of membranes (PPROM']","['ampicillin\u2009+\u2009roxithromycin vs cefuroxime\u2009+\u2009roxithromycin', 'ampicillin\u2009+\u2009roxithromycin', 'cefuroxime\u2009+\u2009roxithromycin', 'prophylactic antibiotic regimen']","['K. pneumonia cultures', 'median latency period', 'Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0035891', 'cui_str': 'Roxithromycin'}, {'cui': 'C0007562', 'cui_str': 'Cefuroxime'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023103', 'cui_str': 'Latency Period (Psychology)'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0235839', 'cui_str': 'Fever of the newborn'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",84.0,0.100097,The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days).,"[{'ForeName': 'Maya Frank', 'Initials': 'MF', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel. Electronic address: homesickid@yahoo.com.'}, {'ForeName': 'Inshirah', 'Initials': 'I', 'LastName': 'Sgayer', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Miron', 'Affiliation': 'Department of Pediatrics A, Emek Medical Center, Afula, Israel; Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Krencel', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}, {'ForeName': 'Vered Fleisher', 'Initials': 'VF', 'LastName': 'Sheffer', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Neonatal Intensive Care Unit, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Suraya Saied', 'Initials': 'SS', 'LastName': 'Idriss', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Israel; Technion - Israel Institute of Technology, Israel.'}, {'ForeName': 'Rami N', 'Initials': 'RN', 'LastName': 'Sammour', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, Israel; Technion - Israel Institute of Technology, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peleg', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Department of Obstetrics and Gynecology, Ziv Medical Center, Safed, Israel.'}, {'ForeName': 'Inbar Ben', 'Initials': 'IB', 'LastName': 'Shachar', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Department of Obstetrics and Gynecology, Ziv Medical Center, Safed, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Rechnitzer', 'Affiliation': 'Azrieli Faculty of Medicine, Bar Ilan University, Israel; Clinical Microbiology Laboratory, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bornstein', 'Affiliation': 'Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel; Azrieli Faculty of Medicine, Bar Ilan University, Israel.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.005']
748,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
749,31655883,A randomized controlled trial: comparing extracorporeal shock wave therapy versus local corticosteroid injection for the treatment of carpal tunnel syndrome.,"PURPOSE


Extracorporeal shock wave therapy (ESWT) has been reported as a new therapy for carpal tunnel syndrome (CTS). However, few studies have compared ESWT with the local corticosteroid injection (LCI).
METHODS


In this study, a randomized controlled trial comparing 30 patients with ESWT and 25 patients treated with LCI was conducted. The clinical outcomes were obtained with tests including the visual analog scale (VAS) for pain and paresthesia, the Boston Carpal Tunnel Questionnaire (BQ), and a nerve conduction study, before the study started and at three, nine, and 12 weeks after the start of the treatment.
RESULTS


Significantly greater improvement in the VAS and BQ scores was noted for the ESWT group than for the LCI group (P < 0.05). For the nerve conduction study, there was a significant improvement in the median nerve sensory nerve action potential distal latency at the nine and 12-week follow-ups for the ESWT group.
CONCLUSIONS


ESWT is a useful noninvasive short-term treatment for mild to moderate carpal tunnel syndrome and elicits a better recovery than LCI does, but more research is needed to test the clinical outcomes of ESWT.",2020,Significantly greater improvement in the VAS and BQ scores was noted for the ESWT group than for the LCI group (P < 0.05).,"['30 patients with ESWT and 25 patients treated with', 'carpal tunnel syndrome (CTS', 'carpal tunnel syndrome']","['ESWT', 'LCI', 'extracorporeal shock wave therapy versus local corticosteroid injection', 'Extracorporeal shock wave therapy (ESWT']","['visual analog scale (VAS) for pain and paresthesia, the Boston Carpal Tunnel Questionnaire (BQ), and a nerve conduction study', 'median nerve sensory nerve action potential distal latency', 'VAS and BQ scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}]","[{'cui': 'C0231990', 'cui_str': 'Lung clearance index (observable entity)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study (procedure)'}, {'cui': 'C0025058', 'cui_str': 'Median Nerve'}, {'cui': 'C0522219', 'cui_str': 'Sensory potential, function (observable entity)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0329762,Significantly greater improvement in the VAS and BQ scores was noted for the ESWT group than for the LCI group (P < 0.05).,"[{'ForeName': 'Dingli', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Ningbo University Medical School, Ningbo, 315000, China.'}, {'ForeName': 'Weihu', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Ningbo No.6 Hospital, Ningbo, 31500, China.'}, {'ForeName': 'Weiyu', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Ningbo No.6 Hospital, Ningbo, 31500, China.'}, {'ForeName': 'Xundong', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Ningbo No.6 Hospital, Ningbo, 31500, China.'}, {'ForeName': 'Fangqian', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Ningbo No.6 Hospital, Ningbo, 31500, China.'}, {'ForeName': 'Chengli', 'Initials': 'C', 'LastName': 'Mao', 'Affiliation': 'Ningbo No.6 Hospital, Ningbo, 31500, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Ningbo No.6 Hospital, Ningbo, 31500, China.'}, {'ForeName': 'Lingyan', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Ningbo No.6 Hospital, Ningbo, 31500, China.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Luo', 'Affiliation': 'Ningbo No.6 Hospital, Ningbo, 31500, China.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Ningbo No.6 Hospital, Ningbo, 31500, China.'}, {'ForeName': 'Zhenqi', 'Initials': 'Z', 'LastName': 'Lou', 'Affiliation': 'Ningbo No.6 Hospital, Ningbo, 31500, China.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Gan', 'Affiliation': 'Ningbo City Medical Treatment Center Lihuili Hospital, Ningbo, 315000, China. gankaifeng@163.com.'}]",International orthopaedics,['10.1007/s00264-019-04432-9']
750,30497085,Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design.,"INTRODUCTION


Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance.
MATERIALS AND METHODS


PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years.
DISCUSSION


PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years.",2020,"INTRODUCTION


Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches.","['patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years', 'Aortic Valve Replacement', 'patients undergoing SAVR in the presence of severe aortic stenosis']","['standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting', 'Sutureless versus Stented Bioprostheses', 'AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement', 'Perceval (LivaNova, London, UK) sutureless bioprosthesis']","['safety and efficacy', 'number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005557', 'cui_str': 'Bioprosthesis'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0005557', 'cui_str': 'Bioprosthesis'}, {'cui': 'C0449217', 'cui_str': 'aVR (body structure)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.0453639,"INTRODUCTION


Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lorusso', 'Affiliation': 'Department of Cardio-Thoracic Surgery, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC\u2009+\u2009), Maastricht, The Netherlands.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Folliguet', 'Affiliation': 'Chirurgie Cardiaque & Transplantation, Assistance Publique, Hôpital, Henri Mondor, Université Paris 12 UPEC, France.'}, {'ForeName': 'Malakh', 'Initials': 'M', 'LastName': 'Shrestha', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Meuris', 'Affiliation': 'Cardiac Surgery Department, Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Thoraxcenter, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roselli', 'Affiliation': 'Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Klersy', 'Affiliation': 'Fondazione IRCCS Policlinico San Matteo, Pavia, Lombardia, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Nozza', 'Affiliation': 'LivaNova Plc, London, United Kingdom.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Verhees', 'Affiliation': 'LivaNova Plc, London, United Kingdom.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Larracas', 'Affiliation': 'LivaNova Plc, London, United Kingdom.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Goisis', 'Affiliation': 'LivaNova Plc, London, United Kingdom.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Fischlein', 'Affiliation': 'Department of Cardiac Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany.'}]",The Thoracic and cardiovascular surgeon,['10.1055/s-0038-1675847']
751,30407039,Competing indirect effects in a comparative psychotherapy trial for generalized anxiety disorder.,"In a randomized trial for generalized anxiety disorder, cognitive-behavioral therapy (CBT) and CBT integrated with motivational interviewing (MI) promoted comparable worry reduction at posttreatment, whereas MI-CBT outperformed CBT over 12-month follow-up (Westra, Constantino, & Antony, 2016). Secondary analyses revealed competing mediators of the long-term treatment effect: MI-CBT related to lower patient resistance to the treatment, which promoted lower follow-up worry, whereas CBT related to greater increases in patient friendly submissiveness (FS), or compliance, which also promoted lower follow-up worry (that suppressed an even greater long-term advantage of MI-CBT). In this study, we tested these competing, though theoretically consistent, variables as mediators of the nonsignificant treatment effect on posttreatment worry, as there could also be treatment-specific means to arriving to these comparable ends. Eighty-five patients received 15 sessions of MI-CBT or CBT. Therapists rated patient FS through treatment, observers rated resistance at midtreatment, and patients rated worry at posttreatment. Bootstrap analyses indicated that MI-CBT patients exhibited less resistance, which promoted lower posttreatment worry, whereas CBT patients had greater increases in FS, which also promoted lower worry. CBT and MI-CBT achieved comparable posttreatment outcomes through separate indirect paths that each conferred an advantage for one treatment over the other (and had canceled out a direct treatment effect immediately after therapy). The composite trial findings have significance for understanding different pathways to personal change in both the short- and long terms, and for the importance of testing indirect effects both when direct treatment effects do and do not emerge. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Secondary analyses revealed competing mediators of the long-term treatment effect: MI-CBT related to lower patient resistance to the treatment, which promoted lower follow-up worry, whereas CBT related to greater increases in patient friendly submissiveness (FS), or compliance, which also promoted lower follow-up worry (that suppressed an even greater long-term advantage of MI-CBT).",['generalized anxiety disorder'],"['MI-CBT or CBT', 'cognitive-behavioral therapy (CBT) and CBT integrated with motivational interviewing (MI']","['FS', 'patient friendly submissiveness (FS), or compliance, which also promoted lower follow-up worry', 'competing mediators of the long-term treatment effect: MI-CBT']","[{'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.016436,"Secondary analyses revealed competing mediators of the long-term treatment effect: MI-CBT related to lower patient resistance to the treatment, which promoted lower follow-up worry, whereas CBT related to greater increases in patient friendly submissiveness (FS), or compliance, which also promoted lower follow-up worry (that suppressed an even greater long-term advantage of MI-CBT).","[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Coyne', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts Amherst.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts Amherst.'}, {'ForeName': 'Henny A', 'Initials': 'HA', 'LastName': 'Westra', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'Department of Psychology, Ryerson University.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000163']
752,22328869,Influences of Family Environment and Meditation Efficacy on Hemodynamic Function among African American Adolescents.,"This study examined the impact of breathing awareness meditation (BAM) compared to health education (HE) and lifeskills training (LS) upon resting systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) within the context of potential moderating factors of family environment and expectancy of benefit. 186 African American adolescents (mean age: 15.1±0.7 yrs) were randomly assigned by school to three-month BAM, LS, or HE interventions. Laboratory resting blood pressure (BP), Family Relations Index (FRI) and expectancy of benefit evaluations were conducted at pre- and post-intervention. Higher expectancy of benefit from any of the three interventions resulted in greater reductions in SBP. A two-way interaction indicated that BAM group subjects who came from positive family environments exhibited greater decreases in SBP. A two-way interaction indicated that BAM and LS subjects who came from positive family environments exhibited greater DBP decreases. A two-way interaction indicated that BAM subjects who came from positive family environments exhibited a greater HR decrease (all p<.05). Expectancy of intervention benefits beneficially impacted success of behavioral interventions aimed at reducing SBP. Positive family environments in combination with either BAM or LS appear to have a beneficial impact upon hemodynamic function in AA adolescents.",2010,A two-way interaction indicated that BAM subjects who came from positive family environments exhibited a greater HR decrease (all p<.05).,"['186 African American adolescents (mean age: 15.1±0.7 yrs', 'AA adolescents', 'African American Adolescents']","['BAM', 'health education (HE) and lifeskills training (LS', 'BAM or LS', 'breathing awareness meditation (BAM', 'Family Environment and Meditation Efficacy']","['Hemodynamic Function', 'Laboratory resting blood pressure (BP), Family Relations Index (FRI) and expectancy of benefit evaluations', 'SBP', 'resting systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0018701'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0150277'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0015608', 'cui_str': 'Family Relationship'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",186.0,0.0245265,A two-way interaction indicated that BAM subjects who came from positive family environments exhibited a greater HR decrease (all p<.05).,"[{'ForeName': 'Vernon A', 'Initials': 'VA', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Gregoski', 'Affiliation': ''}, {'ForeName': 'Martha S', 'Initials': 'MS', 'LastName': 'Tingen', 'Affiliation': ''}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Treiber', 'Affiliation': ''}]",Journal of complementary & integrative medicine,['10.2202/1553-3840.1326']
753,30487565,Sleep and meal timing influence food intake and its hormonal regulation in healthy adults with overweight/obesity.,"BACKGROUND


Studies associate sleeping and eating late in the day with poor dietary quality and higher obesity risk but differences in sleep duration confound this association. We aimed to determine whether sleep and meal timing, independent of sleep duration, influenced food intake in healthy adults.
METHODS


This was a controlled, 2 × 2 inpatient crossover study with normal (0000-0800 h) or late (0330-1130 h) sleep and normal (1, 5, 11, and 12.5 h after awakening) or late (4.5, 8.5, 14.5, and 16 h after awakening) meals. Food intake was controlled while blood samples were obtained for determination of appetite-regulating hormones on days 3-4. Self-selected food intake was assessed on day 5. Data were analyzed using linear mixed model analysis with sleep, meal, and sleep x meal interaction as dependent variables.
RESULTS


Five participants completed all phases (mean age 25.1 ± [SD] 3.9 y, body mass index 29.2 ± 2.7 kg/m 2 ). There was a significant sleep x meal interaction on energy intake (P = 0.035) and trends on fat and sodium intakes (P < 0.10). Overnight ghrelin concentrations were higher under normal sleep and meal conditions relative to late (P < 0.005) but lower when both were combined (P < 0.001). Overnight leptin concentrations were higher under normal meal conditions (P = 0.012). There was a significant sleep x meal interaction on ghrelin (P = 0.032) and glucagon-like peptide 1 (P = 0.041) concentrations, but not leptin (P = 0.83), in response to a test meal.
CONCLUSIONS


Our results suggest that alignment of sleep and meals may influence food choice and energy balance. Additional research is necessary to expand and confirm our findings.",2019,"There was a significant sleep x meal interaction on ghrelin (P = 0.032) and glucagon-like peptide 1 (P = 0.041) concentrations, but not leptin (P = 0.83), in response to a test meal.
","['healthy adults with overweight/obesity', 'Five participants completed all phases (mean age 25.1\u2009±\u2009[SD] 3.9\u2009y, body mass index 29.2\u2009±\u20092.7\u2009kg/m 2 ', '2\u2009×\u20092 inpatient crossover study with normal (0000-0800\u2009h) or late (0330-1130\u2009h) sleep and normal (1, 5, 11, and 12.5\u2009h after awakening) or late (4.5, 8.5, 14.5, and 16\u2009h after awakening) meals', 'healthy adults']",['Sleep and meal timing influence food intake'],"['Overnight leptin concentrations', 'sleep x meal interaction on ghrelin', 'fat and sodium intakes', 'sleep x meal interaction on energy intake', 'Overnight ghrelin concentrations']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",5.0,0.0477511,"There was a significant sleep x meal interaction on ghrelin (P = 0.032) and glucagon-like peptide 1 (P = 0.041) concentrations, but not leptin (P = 0.83), in response to a test meal.
","[{'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'St-Onge', 'Affiliation': 'New York Obesity Nutrition Research Center, Department of Medicine, Columbia University Medical Center, New York, NY, USA. ms2554@cumc.columbia.edu.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Pizinger', 'Affiliation': 'New York Obesity Nutrition Research Center, Department of Medicine, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Kovtun', 'Affiliation': 'New York Obesity Nutrition Research Center, Department of Medicine, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'RoyChoudhury', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy and Research, Weill Cornell Medicine, Cornell University, New York, NY, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0312-x']
754,30396772,"An iso-osmolar oral supplement increases natriuresis and does not increase stomal output in patients with an ileostomy: A randomised, double-blinded, active comparator, crossover intervention study.","BACKGROUND


Patients with an ileostomy often experience fluid and electrolyte depletion because of gastrointestinal loss. This study aimed to compare how an iso-osmolar and a hyperosmolar oral supplement affect ileostomy output, urine production, and natriuresis as proxy measurements of water-electrolyte balance.
METHODS


In a randomised, double-blinded, active comparator, crossover intervention study, we included eight adult ileostomy patients who were independent of parenteral support. We investigated how an iso-osmolar (279 mOsm/kg) and a hyperosmolar (681 mOsm/kg) oral supplement affected ileostomy output mass, urine volume, and natriuresis. In addition to their habitual diet, each participant ingested 800 mL/day of either the iso-osmolar or hyperosmolar supplement in each of two study periods. Each period started with 24-hour baseline measurements, and the supplements were ingested during the following 48 h. All measurements were repeated in the last 24 h.
RESULTS


No statistically significant changes in ileostomy output were detected following the intake of either oral supplement (median (range) 67 (-728 to 290) g/day, p = 0.25) despite increased fluid intake. Compared with the hyperosmolar supplement, the iso-osmolar supplement induced a statistically significant increase in urine volume (470 (0-780) mL/day, p = 0.02) and natriuresis (36 (0-66) mmol/day, p = 0.02).
CONCLUSION


Intake of the two oral supplements did not affect ileostomy output during this short intervention. Natriuresis increased following intake of the iso-osmolar supplement compared to that after ingesting the hyperosmolar supplement, indicating that patients with an ileostomy may benefit from increasing their ingestion of iso-osmolar fluids. ClinicalTrials.gov identifier:NCT03348709.",2019,"No statistically significant changes in ileostomy output were detected following the intake of either oral supplement (median (range) 67 (-728 to 290) g/day, p = 0.25) despite increased fluid intake.","['patients with an ileostomy', 'eight adult ileostomy patients who were independent of parenteral support']",[],"['ileostomy output', 'fluid intake', 'urine volume', 'Natriuresis', 'natriuresis', 'ileostomy output mass, urine volume, and natriuresis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020883', 'cui_str': 'Ileostomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332291', 'cui_str': 'Independent of (attribute)'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],"[{'cui': 'C0020883', 'cui_str': 'Ileostomy'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake (observable entity)'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0027477', 'cui_str': 'Natriuresis'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",8.0,0.477136,"No statistically significant changes in ileostomy output were detected following the intake of either oral supplement (median (range) 67 (-728 to 290) g/day, p = 0.25) despite increased fluid intake.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rud', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, DK-8200, Denmark; Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-1958, Denmark. Electronic address: charru@rm.dk.'}, {'ForeName': 'Anne Kathrine Nissen', 'Initials': 'AKN', 'LastName': 'Pedersen', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, DK-8200, Denmark; Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-1958, Denmark; Department of Biomedicine, Aarhus University, DK-8000, Denmark. Electronic address: ankpe1@rm.dk.'}, {'ForeName': 'Trine Levring', 'Initials': 'TL', 'LastName': 'Wilkens', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, DK-8200, Denmark; Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-1958, Denmark. Electronic address: tlevrings@gmail.com.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Borre', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, DK-8200, Denmark. Electronic address: mette.borre@aarhus.rm.dk.'}, {'ForeName': 'Jens Rikardt', 'Initials': 'JR', 'LastName': 'Andersen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-1958, Denmark. Electronic address: jra@nexs.ku.dk.'}, {'ForeName': 'Hanne B', 'Initials': 'HB', 'LastName': 'Moeller', 'Affiliation': 'Department of Biomedicine, Aarhus University, DK-8000, Denmark. Electronic address: hbmo@biomed.au.dk.'}, {'ForeName': 'Jens Frederik', 'Initials': 'JF', 'LastName': 'Dahlerup', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, DK-8200, Denmark. Electronic address: jensdahl@rm.dk.'}, {'ForeName': 'Christian Lodberg', 'Initials': 'CL', 'LastName': 'Hvas', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, DK-8200, Denmark. Electronic address: chrishva@rm.dk.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.10.014']
755,30500926,Mortality and morbidity following exercise-based renal rehabilitation in patients with chronic kidney disease: the effect of programme completion and change in exercise capacity.,"BACKGROUND


Twelve weeks of renal rehabilitation (RR) have been shown to improve exercise capacity in patients with chronic kidney disease (CKD); however, survival following RR has not been examined.
METHODS


This study included a retrospective longitudinal analysis of clinical service outcomes. Programme completion and improvement in exercise capacity, characterised as change in incremental shuttle walk test (ISWT), were analysed with Kaplan-Meier survival analyses to predict risk of a combined event including death, cerebrovascular accident, myocardial infarction and hospitalisation for heart failure in a cohort of patients with CKD. Time to combined event was examined with Kaplan-Meier plots and log rank test between 'completers' (attended >50% planned sessions) and 'non-completers'. In completers, time to combined event was examined between 'improvers' (≥50 m increase ISWT) and 'non-improvers' (<50 m increase). Differences in time to combined event were investigated with Cox proportional hazards models (adjusted for baseline kidney function, body mass index, diabetes, age, gender, ethnicity, baseline ISWT and smoking status).
RESULTS


In all, 757 patients (male 54%) (242 haemodialysis patients, 221 kidney transplant recipients, 43 peritoneal dialysis patients, 251 non-dialysis CKD patients) were referred for RR between 2005 and 2017. There were 193 events (136 deaths) during the follow-up period (median 34 months). A total of 43% of referrals were classified as 'completers', and time to event was significantly greater when compared with 'non-completers' (P = 0.009). Responding to RR was associated with improved event-free survival time (P = 0.02) with Kaplan-Meier analyses and log rank test. On multivariate analysis, completing RR contributed significantly to the minimal explanatory model relating clinical variables to the combined event (overall χ2 = 38.0, P < 0.001). 'Non-completers' of RR had a 1.6-fold [hazard ratio = 1.6; 95% confidence interval (CI) 1.00-2.58] greater risk of a combined event (P = 0.048). Change in ISWT of >50 m contributed significantly to the minimal explanatory model relating clinical variables to mortality and morbidity (overall χ2 = 54.0, P < 0.001). 'Improvers' had a 40% (hazard ratio = 0.6; 95% CI 0.36-0.98) independent lower risk of a combined event (P = 0.041).
CONCLUSIONS


There is an association between completion of an RR programme, and also RR success, and a lower risk of a combined event in this observational study. RR interventions to improve exercise capacity in patients with CKD may reduce risk of morbidity and mortality, and a pragmatic randomised controlled intervention trial is warranted.",2019,Responding to RR was associated with improved event-free survival time (P = 0.02) with Kaplan-Meier analyses and log rank test.,"['patients with chronic kidney disease (CKD', 'patients with CKD', '757 patients (male 54%) (242 haemodialysis patients, 221 kidney transplant recipients, 43 peritoneal dialysis patients, 251 non-dialysis CKD patients) were referred for RR between 2005 and 2017', 'patients with chronic kidney disease']","['exercise-based renal rehabilitation', 'renal rehabilitation (RR', 'RR interventions']","['time to event', 'death, cerebrovascular accident, myocardial infarction and hospitalisation for heart failure', 'exercise capacity, characterised as change in incremental shuttle walk test (ISWT', 'event-free survival time', 'risk of morbidity and mortality', 'exercise capacity', 'Mortality and morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.135302,Responding to RR was associated with improved event-free survival time (P = 0.02) with Kaplan-Meier analyses and log rank test.,"[{'ForeName': 'Sharlene A', 'Initials': 'SA', 'LastName': 'Greenwood', 'Affiliation': ""Department of Therapies, King's College Hospital, London, UK.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Castle', 'Affiliation': ""Department of Therapies, King's College Hospital, London, UK.""}, {'ForeName': 'Herolin', 'Initials': 'H', 'LastName': 'Lindup', 'Affiliation': ""Department of Therapies, King's College Hospital, London, UK.""}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Mayes', 'Affiliation': ""Department of Therapies, King's College Hospital, London, UK.""}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Waite', 'Affiliation': ""Department of Therapies, King's College Hospital, London, UK.""}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Grant', 'Affiliation': ""Department of Therapies, King's College Hospital, London, UK.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Mangahis', 'Affiliation': ""Department of Therapies, King's College Hospital, London, UK.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Crabb', 'Affiliation': ""Department of Therapies, King's College Hospital, London, UK.""}, {'ForeName': 'Kamer', 'Initials': 'K', 'LastName': 'Shevket', 'Affiliation': ""Department of Therapies, King's College Hospital, London, UK.""}, {'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Macdougall', 'Affiliation': ""Department of Therapies, King's College Hospital, London, UK.""}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'MacLaughlin', 'Affiliation': ""Renal Sciences, Department of Transplantation, Immunology and Mucosal Biology, King's College London University, London, UK.""}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfy351']
756,30423130,"Does low-frequency vibration have an effect on aligner treatment? A single-centre, randomized controlled trial.","BACKGROUND


Low-frequency vibrations have been proposed as a means of accelerating tooth movement and reducing orthodontic treatment times.
OBJECTIVE


To determine any differences in the accuracy of dental movement in patients treated with a low-frequency vibration aligner protocol and/or by reducing the aligner replacement interval with respect to a conventional protocol.
DESIGN


This trial was designed as a single-centre, randomized controlled clinical trial.
METHODS


Participants: Patients (aged 27.1 ± 9.0 years) who required orthodontic treatment with aligners. Randomization: Patients were randomly allocated to three arms as determined by a computer-randomization scheme. Group A were assigned a conventional protocol (aligners replaced every 14 days); group B also used a low-frequency vibration device for 20 minutes per day; group C followed the same vibration protocol but replaced their aligners every 7 days. Blinding: The operator who performed the set-up and the one who analysed the data were blinded to the group of the patients. Outcome: Pre- and post-treatment digital models were analysed using VAM software to identify the accuracy/imprecision of dental movements. One-way analysis of variance (P < 0.05) and the Bonferroni post hoc test were used to identify any statistically significant differences between the three arms in terms of the accuracy of tooth movement versus the prescription.
RESULTS


Numbers analysed: A total of 45 patients (15 for group) were analysed (i.e. 2286 dental movements). Outcome: No statistically significant differences emerged between groups A and C in the upper arch, or among groups A, B, and C in the lower. Group B displayed significantly greater accuracy with respect to group A in upper incisor rotation (P = 0.016), and to group C in vestibulolingual (P = 0.007) and mesiodistal tipping (P = 0.029) of the upper canines, and vestibulolingual tipping of the upper molars (P = 0.0001). Harms: No adverse events or side-effects were registered.
CONCLUSIONS


Considering all tooth and movement types of the 45 participants, the mean total imprecision was 2.1 ± 0.9 degrees, with respect to a mean prescription of 5.7 ± 2.2 degrees. There was no difference in accuracy between replacing the aligners accompanied by low-frequency vibration every 7 days and replacing them every 14 days without vibration. Moreover, low-frequency vibration seemed to improve the accuracy of a conventional protocol in terms of upper incisor rotation.
TRIAL REGISTRATION


The German Clinical Trials Register (DRK00015613).",2019,"Group B displayed significantly greater accuracy with respect to group A in upper incisor rotation (P = 0.016), and to group C in vestibulolingual (P = 0.007) and mesiodistal tipping (P = 0.029) of the upper canines, and vestibulolingual tipping of the upper molars (P = 0.0001).","['45 patients (15 for group) were analysed (i.e. 2286 dental movements', 'patients treated with a low-frequency vibration aligner protocol and/or by reducing the aligner replacement interval with respect to a conventional protocol', 'Methods\n\n\nParticipants: Patients (aged 27.1 ± 9.0 years) who required orthodontic treatment with aligners']","['Accelerating aligner treatment using low-frequency vibration', 'conventional protocol (aligners replaced every 14 days); group B also used a low-frequency vibration device for 20 minutes per day; group C followed the same vibration protocol']","['mesiodistal tipping', 'accuracy', 'upper incisor rotation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3873181', 'cui_str': 'Every fourteen days'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",45.0,0.115544,"Group B displayed significantly greater accuracy with respect to group A in upper incisor rotation (P = 0.016), and to group C in vestibulolingual (P = 0.007) and mesiodistal tipping (P = 0.029) of the upper canines, and vestibulolingual tipping of the upper molars (P = 0.0001).","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Lombardo', 'Affiliation': 'Postgraduate School of Orthodontics, University of Ferrara, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Arreghini', 'Affiliation': 'Postgraduate School of Orthodontics, University of Ferrara, Italy.'}, {'ForeName': 'Luis T', 'Initials': 'LT', 'LastName': 'Huanca Ghislanzoni', 'Affiliation': 'Department of Biomedical Sciences and Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Siciliani', 'Affiliation': 'Postgraduate School of Orthodontics, University of Ferrara, Italy.'}]",European journal of orthodontics,['10.1093/ejo/cjy076']
757,30091976,Diabetes prevalence in rural Indigenous Guatemala: A geographic-randomized cross-sectional analysis of risk.,"BACKGROUND


Developing countries and Indigenous populations are disproportionately affected by global trends in diabetes (T2DM), but inconsistent data are available to corroborate this pattern in Guatemala and indigenous communities in Central America. Historic estimates of T2DM, using a variety of sampling techniques and diagnostic methods, in Guatemala include a T2DM prevalence of: 4·2% (1970) and 8·4% (2003). Objectives of this geographically randomized, cross-sectional analysis of risk include: (1) use HbA1c to determine prevalence of T2DM and prediabetes in rural Indigenous community of Atitlán (2) identify risk factors for T2DM including age, BMI and gender.
METHODS


A spatially random sampling method was used to identify 400 subjects. Prevalence was compared using the confidence interval method, and logistic regression and linear regression were used to assess association between diabetes and risk factors.
FINDINGS


The overall prevalence of T2DM using HbA1c was 13·81% and prediabetes was also 13·81% in Atitlán, representing a tripling in diabetes from historic estimates and a large population with pre-diabetes. The probability of diabetes increased dramatically with increasing age, however no significant overall relationship existed with gender or BMI.
CONCLUSIONS


Diabetes is a larger epidemic than previously expected and appears to be related to ageing rather than BMI. Our proposed explanations for these findings include: possible Indigenous unique genetic susceptibility to T2DM, shortcomings in BMI as a metric for adiposity in assessing risk, changes in lifestyle and diet, and an overall aging population. The conclusion of this study suggest that (1) T2DM in rural regions of Guatemala may be of epidemic proportion. With pre-diabetes, more than 25% of the population will be diabetic in the very near future; (2) Age is a significant risk factor in the Indigenous population but BMI is not. This suggests that in some populations diabetes may be a disease of ageing.",2018,"The overall prevalence of T2DM using HbA1c was 13·81% and prediabetes was also 13·81% in Atitlán, representing a tripling in diabetes from historic estimates and a large population with pre-diabetes.","['rural Indigenous community of Atitlán (2) identify risk factors for T2DM including age, BMI and gender', 'Diabetes prevalence in rural Indigenous Guatemala', 'Guatemala include a T2DM prevalence of: 4·2% (1970) and 8·4% (2003', '400 subjects']",[],['probability of diabetes'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0395142,"The overall prevalence of T2DM using HbA1c was 13·81% and prediabetes was also 13·81% in Atitlán, representing a tripling in diabetes from historic estimates and a large population with pre-diabetes.","[{'ForeName': 'Kent D W', 'Initials': 'KDW', 'LastName': 'Bream', 'Affiliation': 'Department of Family Medicine and Community Health, Raymond and Ruth Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Breyre', 'Affiliation': 'Center for Global Health, Raymond and Ruth Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Garcia', 'Affiliation': 'Harnwell College House, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Calgua', 'Affiliation': 'Harnwell College House, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Chuc', 'Affiliation': ""Hospitalito Atitlán, Canton Ch'utch'aj, Santiago Atitlán, Sololá, Guatemala.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'Center of Excellence for Diversity in Health Education and Research, Raymond and Ruth Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0200434']
758,30649257,Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances: a randomized controlled trial in adults.,"OBJECTIVE


The aim of this study was to investigate the effects of piezocision (surgical protocol with sutures) in orthodontic treatment using CAD/CAM (computer-aided design and computer-aided manufacturing) customized orthodontic appliances.
DESIGN


The study is designed as a parallel group, randomized controlled trial (RCT).
SETTING


University Hospital.
ETHICAL APPROVAL


The study was approved by the ethic committee of the University Hospital Liege, Belgium.
SUBJECTS AND METHODS


This RCT was conducted on 24 adult patients requiring orthodontic treatment to release mild overcrowding. Patients were all treated with a customized appliance and randomly assigned by means of sealed envelopes containing group codes to either a test group treated with piezocision or a control group without any further treatment. A blinded orthodontist validated appliance removal or further adjustments based on the model study.
OUTCOME MEASURES


The overall treatment time and the time between archwire changes were recorded. Moreover, clinical and radiological features such as tooth resorption, gingival recessions, and the presence of scars were evaluated.
RESULTS


A total of 24 patients (12 control and 12 test) completed the study. The overall treatment time was significantly shorter in the test group than the control group. Likewise, the time difference between all arch changes was significantly lower when piezocision was performed, except for the first arch at the mandible and the last arches at both maxillae. During the fine-tuning phase, no significant difference was found between the two groups. All periodontal and radiographic parameters remained stable from the start to the end of treatment in both the groups. However, minor scars were found in 66 per cent cases.
LIMITATIONS


This trial was a single-centre trial.
CONCLUSIONS


Piezocision seems to be an effective method to accelerate orthodontic treatment in cases of mild overcrowding. However, the effect was only observed during the alignment phase and a greater efficiency was found in the maxilla. The technique may be contraindicated in patients with a high smile line since the risk of slight scarring exists.
REGISTRATION


ClinicalTrails.gov (Identifier: NCT03406130).",2019,The overall treatment time was significantly shorter in the test group than the control group.,"['24 adult patients requiring orthodontic treatment to release mild overcrowding', '24 patients (12 control and 12 test) completed the study', 'adults']","['Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances', 'piezocision (surgical protocol with sutures', 'sealed envelopes containing group codes to either a test group treated with piezocision or a control group without any further treatment', 'CAD/CAM']","['overall treatment time', 'overall treatment time and the time between archwire changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029331', 'cui_str': 'Orthodontic Appliances'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",24.0,0.0393089,The overall treatment time was significantly shorter in the test group than the control group.,"[{'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Charavet', 'Affiliation': 'Department of Orthodontics and DentoFacial Orthopedics, University Hospital of Liège, Belgium.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Lecloux', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Belgium.'}, {'ForeName': 'Nastasia', 'Initials': 'N', 'LastName': 'Jackers', 'Affiliation': 'Department of Orthodontics and DentoFacial Orthopedics, University Hospital of Liège, Belgium.'}, {'ForeName': 'Adelin', 'Initials': 'A', 'LastName': 'Albert', 'Affiliation': 'Department of Biostatistics and Medico-Economic Information, University Hospital of Liège, Belgium.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Lambert', 'Affiliation': 'Dental Biomaterials Research Unit, Faculty of Medicine, University of Liège, Belgium.'}]",European journal of orthodontics,['10.1093/ejo/cjy082']
759,31642087,Educating health professionals for cultural competence in emergency situations: A study protocol for a randomized controlled trial.,"AIMS


The current study is aimed at developing a culturally informed education program to increase cultural competence in emergencies among healthcare students and to examine its effectiveness using a randomized controlled trial.
DESIGN


This is a mixed-methods study, which comprises two phases: (a) Development of educational intervention to increase cultural competence, based on a review of published scientific literature and primary data collection from qualitative semi-structured interviews with key informants; (b) Implementation and assessment of the intervention effectiveness in increasing cultural competence in health students, using a randomized controlled trial.
METHODS


The qualitative phase will include semi-structured interviews with 10 key informants. Data will be analysed using Interpretative Phenomenological Analysis. The assessment of intervention efficacy will be examined by a randomized controlled trial. This phase will include a total of 200 undergraduate health profession students who will be randomized (1:1 ratio) to intervention or non-intervention group. Both study groups will complete pre- and postintervention questionnaires assessing three principles of cultural competence: attitudes, knowledge, and skills. The study is supported by 2-year funding, beginning in September 2018.
DISCUSSION


Although the importance of culturally sensitive health services has long been recognized, there is a lack of cultural competence training in the medical education system, especially in the context of emergencies. Incorporating cultural competence education into the curricula offers an appealing strategy to enhance systematic understanding of cultural diversity at the early stages of professional training.
IMPACT


The development of cultural competence training and curricula focusing on situations that may arise during emergencies may play a significant role in minimizing cultural dissonance, improve patient-provider communication, and produce better clinical outcomes.",2020,"Incorporating cultural competence education into the curricula offers an appealing strategy to enhance systematic understanding of cultural diversity at the early stages of professional training.
","['emergencies among health care students', 'emergency situations', '200 undergraduate health profession students', 'health students']","['intervention or non-intervention group', 'educational intervention', 'culturally-informed education program']",[],"[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]",[],,0.0820931,"Incorporating cultural competence education into the curricula offers an appealing strategy to enhance systematic understanding of cultural diversity at the early stages of professional training.
","[{'ForeName': 'Ortal', 'Initials': 'O', 'LastName': 'Slobodin', 'Affiliation': 'Department of Education, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Neta', 'Initials': 'N', 'LastName': 'Clempert', 'Affiliation': 'Department of Middle East Studies, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Yosef', 'Initials': 'Y', 'LastName': 'Kula', 'Affiliation': ""Masters' program in Emergency Medicine, School of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.""}, {'ForeName': 'Odeya', 'Initials': 'O', 'LastName': 'Cohen', 'Affiliation': ""Masters' program in Emergency Medicine, School of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.""}]",Journal of advanced nursing,['10.1111/jan.14245']
760,31468607,The effect of aquatic exercises on the physical and functional fitness of adults with Down syndrome: A non-randomised controlled trial.,"BACKGROUND


The importance of exercise for individuals with Down syndrome (DS) has been well documented. The use of aquatic exercises may be an attractive alternative to land-based exercises for individuals with musculoskeletal conditions such as low muscle tone and excess adiposity as found in adults with DS. As a result, the purpose of the current study was to study the effect of an aquatic training intervention on the functional fitness for adults with DS.
METHODS


Participants were recruited from two intellectually disabled care centres in the Western Cape of South Africa. Twenty-three adults with DS (13 men and 10 women) (31.4 ± 7.4 years) were allocated to an aquatic training group or a control group. The exercise group performed 35 min of aquatic training, three times a week for 6 weeks, with an increase duration of 45 min after 3 weeks. Outcome measures assessed were aerobic capacity, muscular strength, functional ability and balance.
RESULTS


The aerobic capacity and functional ability of the participants in the aquatic group improved significantly than in the control group with strong to medium effect sizes. Two out of the three strength parameters also improved significantly than in the control group.
CONCLUSIONS


The functional fitness of adults with DS improved with an aquatic intervention but was insufficient to improve balance and upper body strength. The improvement of various parameters associated with functional fitness is important in this population who age prematurely, suffer from the early onset of age-related conditions, are vulnerable to falls and susceptible to chronic conditions.",2019,The aerobic capacity and functional ability of the participants in the aquatic group improved significantly than in the control group with strong to medium effect sizes.,"['Twenty-three adults with DS (13 men and 10 women) (31.4\xa0±\xa07.4\xa0years', 'adults with DS', 'adults with Down syndrome', 'individuals with Down syndrome (DS', 'Participants were recruited from two intellectually disabled care centres in the Western Cape of South Africa']","['exercise group performed 35\xa0min of aquatic training', 'aquatic exercises', 'aquatic training intervention', 'aquatic intervention', 'aquatic training group or a control group']","['balance and upper body strength', 'aerobic capacity, muscular strength, functional ability and balance', 'aerobic capacity and functional ability', 'functional fitness']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",23.0,0.0313231,The aerobic capacity and functional ability of the participants in the aquatic group improved significantly than in the control group with strong to medium effect sizes.,"[{'ForeName': 'Pieter-Henk', 'Initials': 'PH', 'LastName': 'Boer', 'Affiliation': 'Department of Human Movement Science, Faculty of Education, Cape Peninsula University of Technology, Wellington, South Africa.'}, {'ForeName': 'Zelda', 'Initials': 'Z', 'LastName': 'de Beer', 'Affiliation': 'Department of Human Movement Science, Faculty of Education, Cape Peninsula University of Technology, Wellington, South Africa.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12687']
761,30642737,"Probiotic and selenium co-supplementation, and the effects on clinical, metabolic and genetic status in Alzheimer's disease: A randomized, double-blind, controlled trial.","BACKGROUND AND AIMS


Combined probiotic and selenium supplementation may improve Alzheimer's disease (AD) by correcting metabolic abnormalities, and attenuating inflammation and oxidative stress. This study aimed to determine the effects of probiotic and selenium co-supplementation on cognitive function and metabolic status among patients with AD.
METHODS


This randomized, double-blind, controlled clinical trial was conducted among 79 patients with AD. Patients were randomly assigned to receive either selenium (200 μg/day) plus probiotic containing Lactobacillus acidophilus, Bifidobacterium bifidum, and Bifidobacterium longum (2 × 10 9  CFU/day each) (n = 27), selenium (200 μg/day) (n = 26) or placebo (n = 26) for 12 weeks.
RESULTS


Selenium supplementation, compared with the placebo, significantly reduced serum high sensitivity C-reactive protein (hs-CRP) (P < 0.001), insulin (P = 0.001), homeostasis model of assessment-insulin resistance (HOMA-IR) (P = 0.002), LDL-cholesterol (P = 0.04) and total-/HDL-cholesterol ratio (P = 0.004), and significantly increased total glutathione (GSH) (P = 0.001) and the quantitative insulin sensitivity check index (QUICKI) (P = 0.01). Compared with only selenium and placebo, probiotic and selenium co-supplementation resulted in a significant increase in mini-mental state examination score (+1.5 ± 1.3 vs. +0.5 ± 1.2 and -0.2 ± 1.1, respectively, P < 0.001). Probiotic plus selenium intake resulted in a significant reduction in hs-CRP (-1.6 ± 1.4 vs. -0.8 ± 1.0 and +0.1 ± 0.5 mg/L, respectively, P < 0.001), and a significant increase in total antioxidant capacity (+89.4 ± 129.6 vs. +20.0 ± 62.5 and -0.7 ± 27.2 mmol/L, respectively, P = 0.001) and GSH (+122.8 ± 136.5 vs. +102.2 ± 135.2 and +1.5 ± 53.2 μmol/L, respectively, P = 0.001) compared with only selenium and placebo. In addition, subjects who received probiotic plus selenium supplements had significantly lower insulin levels (-2.1 ± 2.5 vs. -1.0 ± 1.3 and +0.7 ± 2.0 μIU/mL, respectively, P < 0.001), HOMA-IR (-0.5 ± 0.6 vs. -0.2 ± 0.3 and +0.1 ± 0.4, respectively, P < 0.001), and higher QUICKI (+0.01 ± 0.01 vs. +0.005 ± 0.007 and -0.002 ± 0.01, respectively, P < 0.006) compared with only selenium and placebo. Additionally, probiotic and selenium co-supplementation resulted in a significant reduction in serum triglycerides (-17.9 ± 26.1 vs. -3.5 ± 33.9 and +0.3 ± 9.3 mg/dL, respectively, P = 0.02), VLDL- (-3.6 ± 5.2 vs. -0.7 ± 6.8 and +0.05 ± 1.8 mg/dL, respectively, P = 0.02), LDL- (-8.8 ± 17.8 vs. -8.1 ± 19.2 and +2.7 ± 19.0 mg/dL, respectively, P = 0.04) and total-/HDL-cholesterol (-0.3 ± 0.7 vs. -0.4 ± 0.9 and +0.3 ± 0.6, respectively, P = 0.005) compared with only selenium and placebo.
CONCLUSIONS


Overall, we found that probiotic and selenium co-supplementation for 12 weeks to patients with AD improved cognitive function and some metabolic profiles. This study was registered in the Iranian website (www.irct.ir) for registration of clinical trials (http://www.irct.ir: IRCT20170612034497N5).",2019,"Compared with only selenium and placebo, probiotic and selenium co-supplementation resulted in a significant increase in mini-mental state examination score (+1.5 ± 1.3 vs. +0.5 ± 1.2 and -0.2 ± 1.1, respectively, P < 0.001).","['79 patients with AD', ""Alzheimer's disease"", 'patients with AD']","['selenium and placebo', 'placebo', 'probiotic and selenium supplementation', 'Probiotic plus selenium', 'Probiotic and selenium co-supplementation', 'probiotic plus selenium supplements', 'selenium (200\xa0μg/day) plus probiotic containing Lactobacillus acidophilus, Bifidobacterium bifidum, and Bifidobacterium longum (2\xa0×', 'selenium and placebo, probiotic and selenium co-supplementation', 'probiotic and selenium co-supplementation']","['insulin levels', 'cognitive function and some metabolic profiles', 'quantitative insulin sensitivity check index (QUICKI', 'hs-CRP', 'homeostasis model of assessment-insulin resistance (HOMA-IR', 'LDL-cholesterol', 'serum triglycerides', 'cognitive function and metabolic status', 'total-/HDL-cholesterol ratio', 'total antioxidant capacity', 'VLDL', 'serum high sensitivity C-reactive protein (hs-CRP', 'total-/HDL-cholesterol', 'mini-mental state examination score', 'total glutathione (GSH', 'HOMA-IR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0521939', 'cui_str': 'Selenium supplement'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}]",79.0,0.516881,"Compared with only selenium and placebo, probiotic and selenium co-supplementation resulted in a significant increase in mini-mental state examination score (+1.5 ± 1.3 vs. +0.5 ± 1.2 and -0.2 ± 1.1, respectively, P < 0.001).","[{'ForeName': 'Omid Reza', 'Initials': 'OR', 'LastName': 'Tamtaji', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Heidari-Soureshjani', 'Affiliation': 'Student Research Committee, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Mirhosseini', 'Affiliation': 'School of Public Health, University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Kouchaki', 'Affiliation': 'Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran; Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'Faculty Member of Science Department, Science Faculty, Islamic Azad University, Tehran Central Branch, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_r@yahoo.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.11.034']
762,27132409,"Safety, efficacy, and tolerability of differential treatment to prevent and treat vaginal dryness and vulvovaginitis in diabetic women.","BACKGROUND


Problems affecting the vaginal tract in diabetic women are very often neglected. The efficacy and safety of three gynecological treatments in diabetic women have been assessed.
MATERIALS AND METHODS


A single-blind randomized progressive trial on 48 diabetic women affected by vaginal dryness, dyspareunia, and recurrent Candida infections was carried out. The ICIQ Vaginal Symptoms (ICIQ-VS) questionnaire was administered.
RESULTS


The analysis of the parameters of ICIQ-VS questionnaire among the three groups showed significant difference only for ""dragging pain"" (p = 0.0 19) and ""soreness"" (p = 0.028). In all groups and for all parameters of the questionnaire, improvement of symptoms was observed. In particular, in Group 1 for all symptoms a highly significant difference was observed, to support the already known benefits of the products and of the proposed combination. Significant improvement was also observed in Group 2.
CONCLUSIONS


The proposed treatment with DermoXEN® Ultracalming Special for diabetics and DermoXEN® Vitexyl vaginal gel exert effective moisturizing and soothing action. Indeed, the aforementioned products have been proven effective for the main gynecological problems of diabetic women.",2016,"The analysis of the parameters of ICIQ-VS questionnaire among the three groups showed significant difference only for ""dragging pain"" (p = 0.0 19) and ""soreness"" (p = 0.028).","['48 diabetic women affected by vaginal dryness, dyspareunia, and recurrent Candida infections', 'diabetic women']",[],"['ICIQ-VS questionnaire', 'Safety, efficacy, and tolerability', 'ICIQ Vaginal Symptoms (ICIQ-VS) questionnaire', 'soreness', 'efficacy and safety', 'dragging pain']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0006840', 'cui_str': 'Moniliasis'}]",[],"[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",48.0,0.0431841,"The analysis of the parameters of ICIQ-VS questionnaire among the three groups showed significant difference only for ""dragging pain"" (p = 0.0 19) and ""soreness"" (p = 0.028).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Carati', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zizza', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guido', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Donno', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Stefanizzi', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Serra', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Romano', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ouedraogo', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Megha', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tinelli', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
763,30626198,"Unveiling an 'invisible population': health, substance use, sexual behavior, culture, and discrimination among urban American Indian/Alaska Native adolescents in California.","OBJECTIVES


There are limited public health data on urban American Indian/Alaska Native (AI/AN) populations, particularly adolescents. The current study attempted to address gaps by providing descriptive information on experiences of urban AI/AN adolescents across northern, central, and southern California.
DESIGN


We describe demographics and several behavioral health and cultural domains, including: alcohol and other drug (AOD) use, risky sexual behavior, mental and physical health, discrimination experiences, involvement in traditional practices, and cultural pride and belonging. We recruited 185 urban AI/AN adolescents across northern, central, and southern California from 2014 to 2017 who completed a baseline survey as part of a randomized controlled intervention trial.
RESULTS


Average age was 15.6 years; 51% female; 59% of adolescents that indicated AI/AN descent also endorsed another race or ethnicity. Rates of AOD use in this urban AI/AN sample were similar to rates for Monitoring the Future. About one-third of adolescents reported ever having sexual intercourse, with 15% reporting using alcohol or drugs before sex. Most reported good mental and physical health. Most urban AI/AN adolescents participated in traditional practices, such as attending Pow Wows and learning their tribal history. Adolescents also reported discrimination experiences, including being a victim of racial slurs and discrimination by law enforcement.
CONCLUSIONS


This study describes a select sample of California urban AI/AN adolescents across several behavioral health and cultural domains. Although these adolescents reported numerous discrimination experiences and other stressors, findings suggest that this sample of urban AI/AN teens may be particularly resilient with regard to behavioral health.",2019,"Most urban AI/AN adolescents participated in traditional practices, such as attending Pow Wows and learning their tribal history.","['Average age was 15.6 years; 51% female; 59% of adolescents that indicated AI/AN descent also endorsed another race or ethnicity', '185 urban AI/AN adolescents across northern, central, and southern California from 2014 to 2017 who completed a baseline survey as part of a randomized controlled intervention trial', 'urban American Indian/Alaska Native (AI/AN) populations, particularly adolescents', 'urban American Indian/Alaska Native adolescents in California', 'California urban AI/AN adolescents across several behavioral health and cultural domains', 'experiences of urban AI/AN adolescents across northern, central, and southern California']",[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",[],[],,0.0416615,"Most urban AI/AN adolescents participated in traditional practices, such as attending Pow Wows and learning their tribal history.","[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': ""D'Amico"", 'Affiliation': 'a RAND Corporation , Santa Monica , CA , USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Dickerson', 'Affiliation': 'b UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine , Los Angeles , CA , USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'a RAND Corporation , Santa Monica , CA , USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Klein', 'Affiliation': 'a RAND Corporation , Santa Monica , CA , USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Agniel', 'Affiliation': 'a RAND Corporation , Santa Monica , CA , USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'c Sacred Path Indigenous Wellness Center , Los Angeles , CA , USA.'}]",Ethnicity & health,['10.1080/13557858.2018.1562054']
764,31593697,Oxytocin amplifies the influence of good intentions on social judgments.,"Studies have shown that the evolutionarily conserved neuropeptide oxytocin (OT) promotes various prosocial behaviors, yet there are few studies of the effect of OT on social judgments, especially on judgments when the actor's intention and the final outcome are incongruent. In a double-blind, placebo-controlled experiment, participants were asked to play the role of the recipient in a dictator game and to make social judgments about the dictator after intranasal OT administration. To isolate the outcome and the intention of the dictator's allocation, we developed a novel social judgment task in which recipients were told that 50% of the dictators' proposals would be reversed. The results showed that the effect of OT on social judgment was modulated by intention: OT increased goodness ratings only towards dictators with hyperfair intention. Our findings support the affiliative-motivation theory which states that OT enhances the affiliative motivation and recognition of positive-valence social stimuli.",2020,The results showed that the effect of OT on social judgment was modulated by intention: OT increased goodness ratings only towards dictators with hyperfair intention.,[],"['placebo', 'OT', 'neuropeptide oxytocin (OT', 'Oxytocin']","['social judgments', 'goodness ratings', 'affiliative motivation and recognition of positive-valence social stimuli']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.0469941,The results showed that the effect of OT on social judgment was modulated by intention: OT increased goodness ratings only towards dictators with hyperfair intention.,"[{'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'School of Psychology, Center for Studies of Psychological Application and Key Laboratory of Mental Health and Cognitive Science of Guangdong Province, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Chengyan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'School of Psychology, Center for Studies of Psychological Application and Key Laboratory of Mental Health and Cognitive Science of Guangdong Province, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Rongjun', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, National University of Singapore, Singapore. Electronic address: psyyr@nus.edu.sg.'}]",Hormones and behavior,['10.1016/j.yhbeh.2019.104589']
765,32409002,A novel EML4-ALK BIRC6-ALK double fusion variant in lung adenocarcinoma confers sensitivity to alectinib.,,2020,,[],"['BIRC6-ALK', 'EML4-ALK']",[],[],"[{'cui': 'C0910612', 'cui_str': 'BIRC6 protein, human'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}]",[],,0.0427387,,"[{'ForeName': 'Jiang-Ming', 'Initials': 'JM', 'LastName': 'Zhong', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Gui-Feng', 'Initials': 'GF', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'De-Yu', 'Initials': 'DY', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, PR China. Electronic address: liuzhenhua6909@163.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.04.030']
766,31238710,A supervised exercise intervention fails to improve depressive symptoms and quality of life among sedentary older adults with HIV infection.,"Older people living with HIV (PLWH) experience multimorbidity that can negatively impact quality of life (QoL). Exercise can improve physical function, but effects on QoL are not well understood. 32 PLWH and 37 controls aged 50-75 completed 12-weeks of moderate-intensity exercise, then were randomized to moderate or high-intensity for 12 additional weeks. Depressive symptoms (CES-D scores) were significantly greater and QOL (SF-36 mental and physical summary scores) significantly lower among PLWH at baseline (all  p  < 0.05). PLWH had significantly greater worsening in CES-D scores compared to controls (3.4 [0.7, 6.0];  p  = 0.01) between 13and 24 weeks. Mental QoL changed minimally, with no significant difference in changes by serostatus between weeks 0 and 12 or weeks 13 and 24 ( p  ≤ 0.22). Changes in physical function summary scores were similar by serostatus between 0 and 12 weeks (1.5 [-1.6, 4.6],  p  = 0.35), but declined significantly more among PLWH between 13 and 24 weeks (-4.1 [-7.2,-1],  p  = 0.01). Exercise intensity had no significant effect on changes in CES-D or SF-36 summary scores; high-intensity exercise was associated with greater improvements in vitality/fatigue (4.1 [0.8, 7.3],  p  = 0.02), compared to moderate-intensity. Exercise initiation failed to improve depressive symptoms or QoL among PLWH. Additional interventions may be needed to maximize these patient-reported outcomes among older PLWH initiating an exercise program.",2020,"Exercise intensity had no significant effect on changes in CES-D or SF-36 summary scores; high-intensity exercise was associated with greater improvements in vitality/fatigue (4.1 [0.8, 7.3],  p  = 0.02), compared to moderate-intensity.","['sedentary older adults with HIV infection', '32 PLWH and 37 controls aged 50-75 completed 12-weeks of moderate-intensity exercise', 'Older people living with HIV (PLWH) experience multimorbidity']","['PLWH', 'supervised exercise intervention']","['physical function', 'depressive symptoms and quality of life', 'physical function summary scores', 'Depressive symptoms (CES-D scores', 'depressive symptoms or QoL among PLWH', 'vitality/fatigue', 'CES-D or SF-36 summary scores; high-intensity exercise', 'QOL (SF-36 mental and physical summary scores', 'CES-D scores']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0312202,"Exercise intensity had no significant effect on changes in CES-D or SF-36 summary scores; high-intensity exercise was associated with greater improvements in vitality/fatigue (4.1 [0.8, 7.3],  p  = 0.02), compared to moderate-intensity.","[{'ForeName': 'DeLayna', 'Initials': 'D', 'LastName': 'Goulding', 'Affiliation': 'Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'Wilson', 'Affiliation': 'Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'MaWhinney', 'Affiliation': 'Colorado School of Public Health, Aurora, CO, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Jankowski', 'Affiliation': 'University of Colorado School of Nursing, Aurora, CO, USA.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Erlandson', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO, USA.'}]",AIDS care,['10.1080/09540121.2019.1634788']
767,30440846,Therapeutic Effects of repetitive Transcranial Magnetic Stimulation on Corticospinal Tract Activities and Neuromuscular Properties in Children with Cerebral Palsy.,"The objective of this research was to study the therapeutic effects of repetitive transcranial magnetic stimulation (rTMS) on corticospinal tract (CST) activities, reflex hyper-excitability, muscle stiffness, and the clinical status of children with spastic hemiplegic cerebral palsy (CP). Three children participated in this study. The treatment lasted for 6 weeks. Two of the patients, the experimental group, received rTMS therapy 4 days a week during the first 3 weeks, and then received typical occupational therapy (OT) after each rTMS session during the second 3 weeks. One patient, the control group, received the same treatment except that a sham coil was used. Each rTMS session lasted for 20 minutes and each OT session lasted for 45 minutes. We evaluated CST activities by transcranial magnetic stimulation (TMS), reflex hyperexcitability by H-reflex response, and muscle stiffness by sonoelastography images. The tests were taken before and after the treatment. Major TMS parameters (i.e., motor evoked potential (MEP) latency, MEP p-p amplitude, cortical silent period (cSP), and intensity of pulse) for experimental patients were improved in comparison with the control patient. H response latency and max H response on max M-wave (H/M) were improved for the experimental group compared to the control group. Two parameters of texture analysis of the sonoelastography images (i.e., entropy and contrast) were improved for the experimental group. Clinical evaluations such as 10 meter walk test (10MWT), timed up and go (TUG), and 6 minute walk test (6MWT) were performed before and after the course of treatment and were improved for the experimental group compared to the control group. These results indicated that rTMS therapy can improve CST activities, reflexes, muscle stiffness, and walking capacity of spastic hemiplegic CP. Therefore, it can be considered as an effective therapeutic tool for enhancing neuromuscular abnormalities resulting from CP.",2018,H response latency and max H response on max M-wave (H/M) were improved for the experimental group compared to the control group.,"['children with spastic hemiplegic cerebral palsy (CP', 'Children with Cerebral Palsy']","['typical occupational therapy (OT', 'repetitive transcranial magnetic stimulation (rTMS', 'rTMS therapy', 'repetitive Transcranial Magnetic Stimulation']","['CST activities, reflexes, muscle stiffness, and walking capacity of spastic hemiplegic CP', 'CST activities by transcranial magnetic stimulation (TMS), reflex hyperexcitability by H-reflex response, and muscle stiffness', 'Major TMS parameters (i.e., motor evoked potential (MEP) latency, MEP p-p amplitude, cortical silent period (cSP), and intensity of pulse', 'corticospinal tract (CST) activities, reflex hyper-excitability, muscle stiffness', '10 meter walk test (10MWT), timed up and go (TUG), and 6 minute walk test (6MWT', 'H response latency and max H response on max M-wave (H/M', 'Corticospinal Tract Activities and Neuromuscular Properties']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy (disorder)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0856984', 'cui_str': 'Hyperexcitability'}, {'cui': 'C0018447', 'cui_str': 'H-Reflex'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0936236', 'cui_str': 'Corticospinal Tracts'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",3.0,0.0115968,H response latency and max H response on max M-wave (H/M) were improved for the experimental group compared to the control group.,"[{'ForeName': 'Shokoofeh', 'Initials': 'S', 'LastName': 'Parvin', 'Affiliation': ''}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Shahrokhi', 'Affiliation': ''}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Tafakhori', 'Affiliation': ''}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Irani', 'Affiliation': ''}, {'ForeName': 'Mehrnaz', 'Initials': 'M', 'LastName': 'Rasteh', 'Affiliation': ''}, {'ForeName': 'Mehdi M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2018.8512805']
768,31668693,Anticholinergic burden of long-term medication is an independent risk factor for the development of postoperative delirium: A clinical trial.,"BACKGROUND


Postoperative delirium (POD) is a common complication after surgery.
OBJECTIVE


We sought to determine the association between preoperative anticholinergic load calculated using the anticholinergic drug scale (ADS) and POD in cancer patients over 65 years of age.
DESIGN


A retrospective sub-investigation of a randomised controlled interventional trial.
SETTING


Two tertiary university hospitals.
PATIENTS


Overall, patients aged 65 years and older scheduled for surgical treatment of gastrointestinary, genitourinary or gynaecological cancers.
MAIN OUTCOME MEASURES


The primary outcome was the interaction between anticholinergic drug scale and occurrence of postoperative delirium. Patient clinical parameters and ADS scores were assessed preoperatively. POD screening was conducted for a total of 7 days following surgery using validated measures. Independent associations between ADS and POD were assessed using multivariate logistical regression analyses.
RESULTS


A total of 651 patients (mean age, 71.8 years; 68.5% males) were included. Of those, 66 patients (10.1%) developed POD. The ADS score was independently associated with the occurrence of POD (higher ADS per point OR 1.496; 95% CI 1.09-2.05; p = 0.01). Additionally, age (per year OR 1.06; CI 95% CI 1.01-1.11; p = 0.03) and ASA state (OR 2.16; 95% CI 1.22-3.83; p = 0.01), as well as stay on ICU (yes vs. no OR 2.8; 95% CI 1.57-4.998; p < 0.01), were independently associated with POD.
CONCLUSIONS


ADS assessment according to chronic medication use is a cost-effective, non-invasive method of identifying elderly cancer patients at risk for POD.
TRIAL REGISTRY


www.clinicaltrials.gov. Identifier NCT01278537. Ethics: IRB of Charité University-Medicine Berlin, Germany; EA2/241/08.",2020,The ADS score was independently associated with the occurrence of POD (higher ADS per point OR 1.496; 95% CI 1.09-2.05; p = 0.01).,"['651 patients (mean age, 71.8\u202fyears; 68.5% males) were included', 'patients aged 65\u202fyears and older scheduled for surgical treatment of gastrointestinary, genitourinary or gynaecological cancers', 'cancer patients over 65\u202fyears of age', 'elderly cancer patients at risk for POD', 'Two tertiary university hospitals']",['anticholinergic drug scale (ADS) and POD'],"['occurrence of POD', 'stay on ICU', 'POD', 'interaction between anticholinergic drug scale and occurrence of postoperative delirium', 'ASA state', 'ADS score', 'ADS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0222045'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0222045'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",651.0,0.251531,The ADS score was independently associated with the occurrence of POD (higher ADS per point OR 1.496; 95% CI 1.09-2.05; p = 0.01).,"[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Mueller', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Claudia D', 'Initials': 'CD', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Germany. Electronic address: claudia.spies@charite.de.'}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Eckardt', 'Affiliation': 'Charité Research Group on Geriatrics, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Weiss', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pohrt', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Institute of Biometry and Clinical Epidemiology, Charitéplatz 1, 10117 Berlin, Germany.'}, {'ForeName': 'Klaus-Dieter', 'Initials': 'KD', 'LastName': 'Wernecke', 'Affiliation': 'Charité - Universitätsmedizin Berlin and SOSTANA GmbH, Berlin, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin, Germany; Department of Anesthesiology and Intensive Care Medicine, Klinikum Barnim GmbH, Werner Forßmann Krankenhaus, Eberswalde, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.109632']
769,30590573,Pain relief after orthodontic archwire installation-a comparison between intervention with paracetamol and chewing gum: a randomized controlled trial.,"BACKGROUND


Pain and discomfort are main concerns at the commencement of orthodontic treatment. It may have negative impact on compliance or even discourage patients from being treated. Orthodontic pain can be alleviated by paracetamol or use of chewing gum. However, studies comparing their effectiveness are scarce.
OBJECTIVES


To compare the effectiveness of paracetamol versus chewing gum for pain alleviation and to investigate the frequency of bracket loss during the first day of fixed orthodontic treatment.
TRAIL DESIGN


Prospective randomized multicentre clinical trial.
METHODS


Sixty patients (28 boys and 32 girls), between 12 and 18 years of age were randomly allocated either to take paracetamol (31 patients) or to use chewing gum (29 patients). After one arch bonding and insertion of the initial archwire, the patients rated the sensation of pain on a visual analogue scale with the jaw at rest and when biting after 6 hours (T1), at bedtime (T2), and the next morning (T3). Paracetamol (1000 mg) was taken 1 hour and chewing gum was used 10 minutes prior to pain rating at T2 and T3. A simple method of randomization was used in this study, and blinding of subjects and the operators to the type of intervention was not possible because of the nature of the treatments.
RESULTS


There was no detectable difference in pain sensation between the groups at T1. At T2 and T3 the chewing gum group displayed higher mean values than the paracetamol group but when adjusting for age, gender, and mode of pain registration, there was no significant difference between the groups. There was no bracket loss in the chewing gum group, whereas two patients in the paracetamol group lost two brackets.
CONCLUSIONS


The effect of chewing gum and paracetamol for initial orthodontic pain relief seems equivalent. Short term use of chewing gum is not a risk factor for bracket loss.
TRIAL REGISTRATION


This study was not registered.",2019,"At T2 and T3 the chewing gum group displayed higher mean values than the paracetamol group but when adjusting for age, gender, and mode of pain registration, there was no significant difference between the groups.","['Methods\n\n\nSixty patients (28 boys and 32 girls), between 12 and 18 years of age']","['paracetamol (31 patients) or to use chewing gum', 'paracetamol and chewing gum', 'Paracetamol', 'paracetamol', 'chewing gum and paracetamol', 'chewing gum']","['frequency of bracket loss', 'Pain relief', 'bracket loss', 'Orthodontic pain', 'sensation of pain on a visual analogue scale', 'pain sensation', 'mean values']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4321298', 'cui_str': 'Chewing gum'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0433819,"At T2 and T3 the chewing gum group displayed higher mean values than the paracetamol group but when adjusting for age, gender, and mode of pain registration, there was no significant difference between the groups.","[{'ForeName': 'Abdulrahman K', 'Initials': 'AK', 'LastName': 'Alshammari', 'Affiliation': 'Department of Orthodontics, College of Dentistry, University of Hail, Saudi Arabia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Huggare', 'Affiliation': 'Division of Orthodontics, Department of Dental Medicine, Karolinska Institutet, Stockholm, Sweden.'}]",European journal of orthodontics,['10.1093/ejo/cjy081']
770,31599746,Cold Snare Polypectomy in Patients Taking Dual Antiplatelet Therapy: A Randomized Trial of Discontinuation of Thienopyridines.,"INTRODUCTION


Cold snare polypectomy (CSP) is a safe and effective method for removing polyps ≤10 mm. The aim of this study was to compare the risk of clinically significant bleeding and thromboembolic events after CSP between stopping and continuing thienopyridines in patients taking dual antiplatelet therapy (DAPT).
METHODS


The study was a single-center, noninferiority, and randomized controlled study involving patients who received colonoscopy from October 2015 to October 2016. Patients receiving DAPT with polyps ≤10 mm were randomly assigned to either the DAPT group (patients continued DAPT) or the aspirin group (patients discontinued thienopyridines for 1 week). Primary outcome was clinically significant bleeding. Secondary outcomes included intraprocedural bleeding, nonsignificant hematochezia, and occurrence of thromboembolic events.
RESULTS


Forty-two patients with 104 eligible polyps were allocated to the DAPT group, and 45 patients with 101 eligible polyps were allocated to the aspirin group. Patient demographic characteristics including size, location, shape, and pathology of the removed polyps were similar in the 2 groups. Intraprocedural bleeding and nonsignificant hematochezia rates were also similar between the 2 groups (4.8% vs 2.2%, P = 0.608; 19.0% vs 8.9%, P = 0.170). No thromboembolic event occurred in either group. Only 1 patient (2.4%) in the DAPT group showed clinically significant bleeding. No significant bleeding was found in the aspirin group.
DISCUSSION


Clinically significant bleeding rate after CSP for polyps ≤10 mm in patients continuing to take DAPT was 2.4%. Therefore, CSP is a safe method for removing small polyps even in patients taking DAPT (ClincialTrials.gov number, NCT02865824).",2019,Clinically significant bleeding rate after CSP for polyps ≤10 mm in patients continuing to take DAPT was 2.4%.,"['Patients', 'Patients receiving DAPT with polyps ≤10 mm', 'patients who received colonoscopy from October 2015 to October 2016', '45 patients with 101 eligible polyps', 'Forty-two patients with 104 eligible polyps', 'patients taking dual antiplatelet therapy (DAPT']","['Taking Dual Antiplatelet Therapy', 'Thienopyridines', 'Cold Snare Polypectomy', 'Cold snare polypectomy (CSP', 'aspirin', 'DAPT group (patients continued DAPT', 'DAPT', 'CSP']","['size, location, shape, and pathology of the removed polyps', 'clinically significant bleeding', 'Intraprocedural bleeding and nonsignificant hematochezia rates', 'bleeding rate', 'thromboembolic event', 'intraprocedural bleeding, nonsignificant hematochezia, and occurrence of thromboembolic events', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1120149', 'cui_str': 'thienopyridine'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",42.0,0.0588917,Clinically significant bleeding rate after CSP for polyps ≤10 mm in patients continuing to take DAPT was 2.4%.,"[{'ForeName': 'Dae', 'Initials': 'D', 'LastName': 'Won', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Joon Sung', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Jeong-Seon', 'Initials': 'JS', 'LastName': 'Ji', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Byung-Wook', 'Initials': 'BW', 'LastName': 'Kim', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}, {'ForeName': 'Hwang', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': ""Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.""}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000091']
771,30440907,Effectiveness of the RAPAEL Smart Board for Upper Limb Therapy in Stroke Survivors: A Pilot Controlled Trial.,"We aim to assess the effectiveness of using the RAPAEL Smart Board as an assistive tool for therapists in clinical rehabilitation therapy settings and to investigate if it can be used to improve the motor recovery rate of stroke survivors. The RAPAEL Smart Board is a therapy tool where therapists actively engage patients, giving necessary verbal and physical interventions as in traditional treatment sessions. We conducted a randomized controlled study with 17 stroke survivors. An experimental group received therapy using the RAPAEL Smart Board for 30 minutes a day, 5 days per week, for 4 weeks in addition to their traditional treatments (i.e., 30 minutes of functional arm movement therapy). A control group received two 30-minute sessions of traditional treatment 5 days per week, for 4 weeks. The upper-extremity function was measured using the Wolf Motor Function Test before and after the 4-week interventions. Our results demonstrate that using the RAPAEL Smart Board, in combination with traditional treatment, significantly improves motor recovery when compared to traditional treatments alone.",2018,We aim to assess the effectiveness of using the RAPAEL Smart Board as an assistive tool for therapists in clinical rehabilitation therapy settings and to investigate if it can be used to improve the motor recovery rate of stroke survivors.,"['Stroke Survivors', '17 stroke survivors']",['RAPAEL Smart Board for Upper Limb Therapy'],"['motor recovery', 'upper-extremity function']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0210781,We aim to assess the effectiveness of using the RAPAEL Smart Board as an assistive tool for therapists in clinical rehabilitation therapy settings and to investigate if it can be used to improve the motor recovery rate of stroke survivors.,"[{'ForeName': 'Joonwoo', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hee-Tae', 'Initials': 'HT', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Daneault', 'Affiliation': ''}, {'ForeName': 'Sungji', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Taekyeong', 'Initials': 'T', 'LastName': 'Ryu', 'Affiliation': ''}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sunghoon Ivan', 'Initials': 'SI', 'LastName': 'Lee', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2018.8512813']
772,30440913,The Effects of Low Frequency Repetitive Transcranial Magnetic Stimulation on White Matter Structural Connectivity in Children with Cerebral Palsy.,"Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment technique for recovery of movement disorders by altering cortical plasticity. In this research, we studied the effects of low-frequency rTMS on white matter (WM) structural connectivity and clinical parameters in children with cerebral palsy (CP).,Four spastic hemiplegic CP children were randomly divided into experimental and control groups. In the experimental group, at first, 1Hz rTMS treatment was performed 4 days/week for 3 weeks on two hemiplegia patients over a contralesional primary motor cortex (M1). Then, 1Hz rTMS treatment was performed 4 days/week for 3 weeks followed by a 30min occupational therapy (OT). In the control group, two CP children received sham rTMS for 3 weeks and then sham rTMS combined with OT for 3 weeks in the same schedule as the experimental group. Evaluations performed using diffusion tensor imaging (DTI), and clinical measurements of gait performance before and after the treatment. Graph theoretical analysis was used to characterize topological changes of structural connectivity. Our findings demonstrate the 1Hz rTMS is effective in improving motor activity in spastic hemiplegic CP children, and is more effective when combined with OT.",2018,"Our findings demonstrate the 1Hz rTMS is effective in improving motor activity in spastic hemiplegic CP children, and is more effective when combined with OT.","['children with cerebral palsy (CP).,Four spastic hemiplegic CP children', 'Children with Cerebral Palsy', 'spastic hemiplegic CP children']","['1Hz rTMS', 'Low Frequency Repetitive Transcranial Magnetic Stimulation', 'diffusion tensor imaging (DTI', 'low-frequency rTMS', 'rTMS combined with OT', 'Repetitive transcranial magnetic stimulation (rTMS', 'sham rTMS']",['motor activity'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0026606', 'cui_str': 'Motor Activity'}]",,0.0141495,"Our findings demonstrate the 1Hz rTMS is effective in improving motor activity in spastic hemiplegic CP children, and is more effective when combined with OT.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Marzbani', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shahrokhi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Irani', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mehdinezhad', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kohanpour', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2018.8512866']
773,30601990,Dental arch effects after early and later timed cervical headgear treatment-a randomized controlled trial.,"BACKGROUND


Cervical headgear (CH) is a commonly used orthodontic appliance and its dentoalveolar changes are known. However, the effects related to gender and timing have gained less attention.
OBJECTIVES


To examine dimensions of dental arches among children with Class II occlusion without posterior mandibular rotation according to timing of Kloehn-type CH treatment.
TRIAL DESIGN


Prospective, randomized, parallel-group controlled trial.
METHODS


Sixty-seven seven-year-old children with a Class II occlusion were included in the study. The children were randomized into two equal-size groups in 1:1 ratio by sealed-envelope randomization. The early group (EG, n = 33) was treated between T0 and T1 (26 months), right after eruption of the first maxillary molars. The late group (LG, n = 34) was treated between T1 and T2 (24 months). The children were treated with CH until normal Class I occlusion on first molars was achieved. Impressions for dental casts were taken from all participants at T0, T1, and T2. Blinding was applicable for outcome assessors. Changes in dental cast measurements were compared between the groups and genders using t-test, Mann-Whitney U-test, and repeated measures analysis of variance.
RESULTS


Of the children, 56 completed the study. The maxillary arch length and the transversal changes between the upper canines and upper first molars were significantly increased in EG at T0-T1 (P < 0.001). At T2, the transversal dimension between the upper first molars was larger (P < 0.05), and in the lower arch the mandibular arch length (P < 0.05) and the transversal dimension between the lower first molars (P < 0.01) were increased in EG males compared to LG males. No harms were encountered.
CONCLUSIONS


The male gender benefits most from early timing of the CH treatment, showing larger dimensions at the end of the follow-up. The results clearly indicated a wider and longer upper dental arch and spontaneous expansion of the lower dental arch after treatment.
CLINICAL REGISTRATION


NCT02010346.",2019,"At T2, the transversal dimension between the upper first molars was larger (P < 0.05), and in the lower arch the mandibular arch length (P < 0.05) and the transversal dimension between the lower first molars (P < 0.01) were increased in EG males compared to LG males.","['children', 'children with Class II occlusion without posterior mandibular rotation according to timing of Kloehn-type CH treatment', 'Methods\n\n\nSixty-seven seven-year-old children with a Class II occlusion were included in the study']","['\n\n\nCervical headgear (CH', 'T0-T1', 'CH']","['wider and longer upper dental arch and spontaneous expansion', 'mandibular arch length', 'dental cast measurements', 'maxillary arch length and the transversal changes', 'transversal dimension']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0011325', 'cui_str': 'Dental Arch'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0231063', 'cui_str': 'First branchial arch structure'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}]",,0.0535027,"At T2, the transversal dimension between the upper first molars was larger (P < 0.05), and in the lower arch the mandibular arch length (P < 0.05) and the transversal dimension between the lower first molars (P < 0.01) were increased in EG males compared to LG males.","[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Julku', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Hannula', 'Affiliation': 'Department of Oral Development and Orthodontics, Research Unit of Oral Health Sciences, University of Oulu, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Pirilä-Parkkinen', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}, {'ForeName': 'Mimmi', 'Initials': 'M', 'LastName': 'Tolvanen', 'Affiliation': 'Department of Community Dentistry, Institute of Dentistry, University of Turku, Finland.'}, {'ForeName': 'Pertti', 'Initials': 'P', 'LastName': 'Pirttiniemi', 'Affiliation': 'Oral and Maxillofacial Department, Oulu University Hospital, Finland.'}]",European journal of orthodontics,['10.1093/ejo/cjy083']
774,31811686,Young children are more likely to cheat after overhearing that a classmate is smart.,"Research on moral socialization has largely focused on the role of direct communication and has almost completely ignored a potentially rich source of social influence: evaluative comments that children overhear. We examined for the first time whether overheard comments can shape children's moral behavior. Three- and 5-year-old children (N = 200) participated in a guessing game in which they were instructed not to cheat by peeking. We randomly assigned children to a condition in which they overheard an experimenter tell another adult that a classmate who was no longer present is smart, or to a control condition in which the overheard conversation consisted of non-social information. We found that 5-year-olds, but not 3-year-olds, cheated significantly more often if they overheard the classmate praised for being smart. These findings show that the effects of ability praise can spread far beyond the intended recipient to influence the behavior of children who are mere observers, and they suggest that overheard evaluative comments can be an important force in shaping moral development.",2020,"We found that 5-year-olds, but not 3-year-olds, cheated significantly more often if they overheard the classmate praised for being smart.","['Three- and 5-year-old children (N\xa0=\xa0200) participated in a guessing game in which they were instructed not to cheat by peeking', 'Young children']","['condition in which they overheard an experimenter tell another adult that a classmate who was no longer present is smart, or to a control condition in which the overheard conversation consisted of non-social information']",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",[],,0.0291003,"We found that 5-year-olds, but not 3-year-olds, cheated significantly more often if they overheard the classmate praised for being smart.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, PR China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, PR China.'}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, PR China.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Compton', 'Affiliation': 'Institute of Psychological Sciences, Hangzhou Normal University, Hangzhou, PR China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Dr Eric Jackman Institute of Child Study, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Gail D', 'Initials': 'GD', 'LastName': 'Heyman', 'Affiliation': 'Department of Psychology, University of California San Diego, La Jolla, CA, USA.'}]",Developmental science,['10.1111/desc.12930']
775,30414864,"Effect of NGM282, an FGF19 analogue, in primary sclerosing cholangitis: A multicenter, randomized, double-blind, placebo-controlled phase II trial.","BACKGROUND & AIMS


Primary sclerosing cholangitis (PSC) is an inflammatory, cholestatic and progressively fibrotic liver disease devoid of effective medical intervention. NGM282, an engineered, non-tumorigenic FGF19 analogue, potently regulates CYP7A1-mediated bile acid homeostasis. We assessed the activity and safety of NGM282 in patients with PSC.
METHODS


In this double-blind, placebo-controlled phase II trial, 62 patients who had PSC confirmed by cholangiography or biopsy and an elevated alkaline phosphatase (ALP) >1.5 × the upper limit of normal were randomly assigned 1:1:1 to receive NGM282 1 mg, 3 mg or placebo once daily for 12 weeks. The primary outcome was the change in ALP from baseline to week 12. Secondary and exploratory outcomes included changes in serum biomarkers of bile acid metabolism and fibrosis. Efficacy analysis was by intention-to-treat.
RESULTS


At 12 weeks, there were no significant differences in the mean change from baseline in ALP between the NGM282 and placebo groups, and therefore, the primary endpoint was not met. However, NGM282 significantly reduced levels of 7alpha-hydroxy-4-cholesten-3-one (a marker of hepatic CYP7A1 activity, LS mean differences -6.2 ng/ml (95% CI -10.7 to -1.7; p = 0.008) and -9.4 ng/ml (-14.0 to -4.9; p <0.001) in the NGM282 1 mg and 3 mg groups, respectively, compared with placebo) and bile acids. Importantly, fibrosis biomarkers that predict transplant-free survival, including Enhanced Liver Fibrosis score and Pro-C3, were significantly improved following NGM282 treatment. Most adverse events were mild to moderate in severity, with gastrointestinal symptoms more frequent in the NGM282 treatment groups.
CONCLUSIONS


In patients with PSC, NGM282 potently inhibited bile acid synthesis and decreased fibrosis markers, without significantly affecting ALP levels.
LAY SUMMARY


We present for the first time, the clinical and laboratory effects of a first-in-class, engineered analogue of the endocrine hormone FGF19 in patients with primary sclerosing cholangitis (PSC). By incorporating non-invasive markers of fibrosis, beyond standard liver injury markers, we show that NGM282 impacted on fibrosis turnover and hepatic inflammation without changing alkaline phosphatase. Our findings demonstrate the complexities of using highly potent rational agents in PSC, and furthermore challenge the dogma about what the appropriate endpoints should be for trials in PSC.",2019,"At 12 weeks, there were no significant differences in the mean change from baseline in ALP between the NGM282 and placebo groups, and therefore, the primary endpoint was not met.","['patients with primary sclerosing cholangitis (PSC', 'primary sclerosing cholangitis', 'patients with PSC', '62 patients who had PSC confirmed by cholangiography or biopsy and an elevated alkaline phosphatase (ALP) >1.5\u202f×\u202fthe upper limit of normal']","['NGM282', 'endocrine hormone FGF19', 'placebo', 'NGM282 1\u202fmg, 3\u202fmg or placebo']","['Enhanced Liver Fibrosis score and Pro-C3', 'changes in serum biomarkers of bile acid metabolism and fibrosis', 'activity and safety of NGM282', 'levels of 7alpha-hydroxy-4-cholesten-3-one', 'bile acid synthesis and decreased fibrosis markers', 'change in ALP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis (disorder)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0008307', 'cui_str': 'Cholangiography'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0239946', 'cui_str': 'Fibrosis, Liver'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0071997', 'cui_str': 'C3 Precursor'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0049730', 'cui_str': '7alpha-hydroxy-4-cholesten-3-one'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",62.0,0.508749,"At 12 weeks, there were no significant differences in the mean change from baseline in ALP between the NGM282 and placebo groups, and therefore, the primary endpoint was not met.","[{'ForeName': 'Gideon M', 'Initials': 'GM', 'LastName': 'Hirschfield', 'Affiliation': 'National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, United Kingdom; University Hospitals Birmingham, Birmingham, United Kingdom; Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, United Kingdom; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Canada. Electronic address: gideon.hirschfield@uhn.ca.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chazouillères', 'Affiliation': 'Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Hepatology and Gastroenterology Department, Saint-Antoine University Hospital, Assistance Publique-Hopitaux de Paris, and INSERM UMR S938, Sorbonne University, Paris, France.'}, {'ForeName': 'Joost P', 'Initials': 'JP', 'LastName': 'Drenth', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud UMC, Nijmegen, the Netherlands.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Thorburn', 'Affiliation': 'Sheila Sherlock Liver Centre and UCL Institute of Liver and Digestive Health, Royal Free Hospital, London, United Kingdom.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Landis', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Washington, Seattle, United States.'}, {'ForeName': 'Marlyn J', 'Initials': 'MJ', 'LastName': 'Mayo', 'Affiliation': 'University Texas Southwestern Medical Center, Dallas, United States.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Muir', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Duke University, Durham, United States.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Trotter', 'Affiliation': 'Texas Digestive Disease Consultants, Clinical Research, Southlake, United States.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Leeming', 'Affiliation': 'Nordic Bioscience, Herlev, Denmark.'}, {'ForeName': 'Morten A', 'Initials': 'MA', 'LastName': 'Karsdal', 'Affiliation': 'Nordic Bioscience, Herlev, Denmark.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Jaros', 'Affiliation': 'Summit Analytical, Denver, United States.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ling', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, United States.'}, {'ForeName': 'Kathline H', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, United States.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Rossi', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, United States.'}, {'ForeName': 'Ransi M', 'Initials': 'RM', 'LastName': 'Somaratne', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, United States.'}, {'ForeName': 'Alex M', 'Initials': 'AM', 'LastName': 'DePaoli', 'Affiliation': 'NGM Biopharmaceuticals, South San Francisco, United States.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Beuers', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}]",Journal of hepatology,['10.1016/j.jhep.2018.10.035']
776,29949284,Responsiveness of the Endometriosis Health Profile-30 questionnaire in a Swedish sample: an observational study.,"OBJECTIVE


The objective was to evaluate the responsiveness of the Endometriosis Health Profile-30 (EHP-30) questionnaire in a Swedish sample.
MATERIALS AND METHODS


Forty-two patients with endometriosis were included in a prospective observational study.
MAIN OUTCOME MEASURES


The changes on the EHP-30 questionnaire after pertubation treatment were compared with the patients' self-estimated change in pain intensity. The responsiveness to change was evaluated with effect sizes and significance of change (paired t-test). The changes in scores between those who improved / not improved were compared with independent t-test.
RESULTS


The changes in the scores were significant for all dimensions on the core questionnaire (p = 0.04-0.0002) for improved patients in contrast to the patients in the stable group where there were no significant changes in any dimension (p = 0.16-0.63). The effect sizes were large (> 0.8) on all core scales except for self-image (0.51) for the improved patients and small on all scales in the non-improved (stable) group (- 0.17-0.35). There were significant differences between the improved and the stable group considering change in most of the core EHP-30 scores.
CONCLUSIONS


The EHP-30 is responsive to improvement on all core scales and is acceptable, understandable, and applicable in this Swedish sample.",2017,"There were significant differences between the improved and the stable group considering change in most of the core EHP-30 scores.
","['Endometriosis Health Profile-30 questionnaire in a Swedish sample', 'Forty-two patients with endometriosis']",[],"['Endometriosis Health Profile-30 (EHP-30) questionnaire', 'EHP-30 questionnaire', 'pain intensity']","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",42.0,0.0380305,"There were significant differences between the improved and the stable group considering change in most of the core EHP-30 scores.
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wickstrom', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Spira', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Edelstam', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
777,31350938,"The beneficial effect of traditional Japanese herbal (Kampo) medicine, Hochu-ekki-to (Bu-Zhong-Yi-Qi-Tang), for patients with chronic wounds refractory to conventional therapies: A prospective, randomized trial.","Hochu-ekki-to (HET) is a traditional Japanese herbal (Kampo) medicine for the treatment of severe weakness, loss of appetite, and indigestion in elderly patients and for the prevention of opportunistic infections. The impact of HET on patients with chronic wounds refractory to conventional therapies was investigated in a prospective, randomized trial, including 18 patients divided into medication (7.5 g oral HET per day, n = 9) and control (n = 9) groups. Wound healing during the 12-week study period was scored based on depth, exudate, size, inflammation/infection, granulation tissue, necrotic tissue, and pocket size. At 12 weeks, wound healing progressed in all nine patients in the medication group, whereas wound healing progressed in only three patients in the control group (significant difference, p < 0.01; relative risk: 3.00). In the medication group, the total score decreased significantly at 8 weeks and later. To the best of our knowledge, this study was the first to show that HET promoted the healing of chronic wounds resistant to conventional treatments. HET may be a choice as an adjunctive therapy for chronic wounds, particularly for patients with malnutrition. This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000031620).",2019,"At 12 weeks, wound healing progressed in all nine patients in the medication group, whereas wound healing progressed in only three patients in the control group (significant difference, p < 0.01; relative risk: 3.00).","['patients with chronic wounds refractory to conventional therapies', '18 patients divided into medication (7.5\u2009g oral HET per day, n = 9) and control (n = 9) groups', 'patients with malnutrition']","['Japanese herbal (Kampo) medicine', 'traditional Japanese herbal (Kampo) medicine, Hochu-ekki-to (Bu-Zhong-Yi-Qi-Tang', 'HET', 'Hochu-ekki-to (HET']","['total score', 'depth, exudate, size, inflammation/infection, granulation tissue, necrotic tissue, and pocket size', 'Wound healing', 'wound healing progressed']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}]","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2240391', 'cui_str': 'Herbal medicine (product)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0911380', 'cui_str': 'hochu-ekki-to'}, {'cui': 'C0911379', 'cui_str': 'herbal drug HET'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0015388', 'cui_str': 'Exudate'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0018180', 'cui_str': 'Granulation Tissue'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]",,0.0255516,"At 12 weeks, wound healing progressed in all nine patients in the medication group, whereas wound healing progressed in only three patients in the control group (significant difference, p < 0.01; relative risk: 3.00).","[{'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Akita', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Namiki', 'Affiliation': 'Department of Japanese-Oriental (Kampo) Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Naoaki', 'Initials': 'N', 'LastName': 'Rikihisa', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Chiba Rosai Hospital, Chiba, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Tokumoto', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Chiba Cancer Center Hospital, Chiba, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Tezuka', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Kubota', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Motone', 'Initials': 'M', 'LastName': 'Kuriyama', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Michimi', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Japanese-Oriental (Kampo) Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Mitsukawa', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12753']
778,24111262,Differential entropy feature for EEG-based vigilance estimation.,"This paper proposes a novel feature called differential entropy for EEG-based vigilance estimation. By mathematical derivation, we find an interesting relationship between the proposed differential entropy and the existing logarithm energy spectrum. We present a physical interpretation of the logarithm energy spectrum which is widely used in EEG signal analysis. To evaluate the performance of the proposed differential entropy feature for vigilance estimation, we compare it with four existing features on an EEG data set of twenty-three subjects. All of the features are projected to the same dimension by principal component analysis algorithm. Experiment results show that differential entropy is the most accurate and stable EEG feature to reflect the vigilance changes.",2013,Experiment results show that differential entropy is the most accurate and stable EEG feature to reflect the vigilance changes.,[],[],[],[],[],[],,0.0266549,Experiment results show that differential entropy is the most accurate and stable EEG feature to reflect the vigilance changes.,"[{'ForeName': 'Li-Chen', 'Initials': 'LC', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Jiao', 'Affiliation': ''}, {'ForeName': 'Bao-Liang', 'Initials': 'BL', 'LastName': 'Lu', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2013.6611075']
779,30222511,Transoceanic Telementoring of Tube Thoracostomy Insertion: A Randomized Controlled Trial of Telementored Versus Unmentored Insertion of Tube Thoracostomy by Military Medical Technicians.,"Background:   Tension pneumothorax is a frequent cause of potentially preventable death. Tube thoracostomy (TT) can obviate death but is invasive and fraught with complications even in experienced hands. We assessed the utility of a remote international virtual network (RIVN) of specialized mentors to remotely guide military medical technicians (medics) using wireless informatics.   Methods:   Medics were randomized to insert TT in training mannequins (TraumaMan; Abacus ALS, Meadowbrook, Australia) supervised by RIVN or not. The RIVN consisted of trauma surgeons in Canada and Australia and a senior medic in Ohio. Medics wore a helmet-mounted wireless camera with laser pointer to confirm anatomy and two-way voice communication using commercial software (Skype ® ). Performance was measured through objective task completion (pass/fail) regarding safety during the procedure, proper location, and secure anchoring of the tube, in addition to remote mentor opinion and subjective debrief.   Results:   Fourteen medics attempted TT, seven mentored and seven not. The RIVN was functional and surgeons on either side of the globe had real-time communication with the mentees. TT placement was considered safe, successful, and secure in 100% of mentored ( n  = 7) procedures, although two (29%) received corrective remote guidance. All (100%) of the unmentored attempted and adequately secured the TT and were safe. However, only 71% ( n  = 5) completed the task successfully ( p  = 0.46). Participating medics subjectively felt remote telementoring (RTM) increased self-confidence (strong agreement mean 5/5 ± 0); confidence to perform field TT (agreement (4/5 ± 1); and decreased anxiety (strong agreement 5/5 ± 1). Subjectively, the remote mentors felt in 100% of the mentored procedures that ""yes"" they were able to assist the medics (1.86 ± 0.38), and in 71% ( n  = 5) felt ""yes"" they made TT safer (2.29 ± 0.49).   Conclusions:   RTM descriptively increased the success of TT placement and allowed for real-time troubleshooting from thousands of kilometers with a redundant capability. RTM was subjectively associated with high levels of satisfaction and self-reported self-confidence. Continued controlled and critical evaluation and refinement of telemedical techniques should continue. Trial Registration: ID ISRCTN/77929274.",2019,Participating medics subjectively felt remote telementoring (RTM) increased self-confidence (strong agreement mean 5/5 ± 0); confidence to perform field TT (agreement (4/5 ± 1); and decreased anxiety (strong agreement 5/5 ± 1).,"['trauma surgeons in Canada and Australia and a senior medic in Ohio', 'Medics', 'by Military Medical Technicians']","['TT placement', 'RTM', 'Telementored Versus Unmentored Insertion of Tube Thoracostomy', 'remote international virtual network (RIVN', 'Transoceanic Telementoring of Tube Thoracostomy Insertion', 'TT in training mannequins (TraumaMan; Abacus ALS, Meadowbrook, Australia) supervised by RIVN or not', 'Tube thoracostomy (TT']","['self-confidence', 'anxiety', 'success of TT placement']","[{'cui': 'C0586908', 'cui_str': 'Trauma surgeon (occupation)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0554178', 'cui_str': 'Medical technician (occupation)'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0189476', 'cui_str': 'Tube thoracostomy'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C3878323', 'cui_str': 'Abacus'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",,0.0865309,Participating medics subjectively felt remote telementoring (RTM) increased self-confidence (strong agreement mean 5/5 ± 0); confidence to perform field TT (agreement (4/5 ± 1); and decreased anxiety (strong agreement 5/5 ± 1).,"[{'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Kirkpatrick', 'Affiliation': '1Regional Trauma Services, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'McKee', 'Affiliation': '1Regional Trauma Services, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Netzer', 'Affiliation': '3Israeli Defence Force Medical Corp, Haifa, Israel.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'McBeth', 'Affiliation': '1Regional Trauma Services, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': ""D'Amours"", 'Affiliation': '4Liverpool Hospital, Liverpool, Australia.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Kock', 'Affiliation': '2Canadian Forces Medical Services, Ottawa, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Dobron', 'Affiliation': '3Israeli Defence Force Medical Corp, Haifa, Israel.'}, {'ForeName': 'Chad G', 'Initials': 'CG', 'LastName': 'Ball', 'Affiliation': '1Regional Trauma Services, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Elon', 'Initials': 'E', 'LastName': 'Glassberg', 'Affiliation': '3Israeli Defence Force Medical Corp, Haifa, Israel.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0138']
780,30100375,"Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial.","BACKGROUND


Cutaneous T-cell lymphomas are rare non-Hodgkin lymphomas with substantial morbidity and mortality in advanced disease stages. We compared the efficacy of mogamulizumab, a novel monoclonal antibody directed against C-C chemokine receptor 4, with vorinostat in patients with previously treated cutaneous T-cell lymphoma.
METHODS


In this open-label, international, phase 3, randomised controlled trial, we recruited patients with relapsed or refractory mycosis fungoides or Sézary syndrome at 61 medical centres in the USA, Denmark, France, Italy, Germany, the Netherlands, Spain, Switzerland, the UK, Japan, and Australia. Eligible patients were aged at least 18 years (in Japan, ≥20 years), had failed (for progression or toxicity as assessed by the principal investigator) at least one previous systemic therapy, and had an Eastern Cooperative Oncology Group performance score of 1 or less and adequate haematological, hepatic, and renal function. Patients were randomly assigned (1:1) using an interactive voice web response system to mogamulizumab (1·0 mg/kg intravenously on a weekly basis for the first 28-day cycle, then on days 1 and 15 of subsequent cycles) or vorinostat (400 mg daily). Stratification was by cutaneous T-cell lymphoma subtype (mycosis fungoides vs Sézary syndrome) and disease stage (IB-II vs III-IV). Since this study was open label, patients and investigators were not masked to treatment assignment. The primary endpoint was progression-free survival by investigator assessment in the intention-to-treat population. Patients who received one or more doses of study drug were included in the safety analyses. This study is ongoing, and enrolment is complete. This trial was registered with ClinicalTrials.gov, number NCT01728805.
FINDINGS


Between Dec 12, 2012, and Jan 29, 2016, 372 eligible patients were randomly assigned to receive mogamulizumab (n=186) or vorinostat (n=186), comprising the intention-to-treat population. Two patients randomly assigned to mogamulizumab withdrew consent before receiving study treatment; thus, 370 patients were included in the safety population. Mogamulizumab therapy resulted in superior investigator-assessed progression-free survival compared with vorinostat therapy (median 7·7 months [95% CI 5·7-10·3] in the mogamulizumab group vs 3·1 months [2·9-4·1] in the vorinostat group; hazard ratio 0·53, 95% CI 0·41-0·69; stratified log-rank p<0·0001). Grade 3-4 adverse events of any cause were reported in 75 (41%) of 184 patients in the mogamulizumab group and 76 (41%) of 186 patients in the vorinostat group. The most common serious adverse events of any cause were pyrexia in eight (4%) patients and cellulitis in five (3%) patients in the mogamulizumab group; and cellulitis in six (3%) patients, pulmonary embolism in six (3%) patients, and sepsis in five (3%) patients in the vorinostat group. Two (67%) of three on-treatment deaths with mogamulizumab (due to sepsis and polymyositis) and three (33%) of nine on-treatment deaths with vorinostat (two due to pulmonary embolism and one due to bronchopneumonia) were considered treatment-related.
INTERPRETATION


Mogamulizumab significantly prolonged progression-free survival compared with vorinostat, and could provide a new, effective treatment for patients with mycosis fungoides and, importantly, for Sézary syndrome, a subtype that represents a major therapeutic challenge in cutaneous T-cell lymphoma.
FUNDING


Kyowa Kirin.",2018,"Mogamulizumab therapy resulted in superior investigator-assessed progression-free survival compared with vorinostat therapy (median 7·7 months [95% CI 5·7-10·3] in the mogamulizumab group vs 3·1 months [2·9-4·1] in the vorinostat group; hazard ratio 0·53, 95% CI 0·41-0·69; stratified log-rank p<0·0001).","['patients with relapsed or refractory mycosis fungoides or Sézary syndrome at 61 medical centres in the USA, Denmark, France, Italy, Germany, the Netherlands, Spain, Switzerland, the UK, Japan, and Australia', 'Eligible patients were aged at least 18 years (in Japan, ≥20 years), had failed (for progression or toxicity as assessed by the principal investigator) at least one previous systemic therapy, and had an Eastern Cooperative Oncology Group performance score of 1 or less and adequate haematological, hepatic, and renal function', 'Patients who received one or more doses of study drug were included in the safety analyses', 'Between Dec 12, 2012, and Jan 29, 2016, 372 eligible patients', '370 patients were included in the safety population', 'patients with mycosis fungoides', 'patients with previously treated cutaneous T-cell lymphoma']","['vorinostat', 'interactive voice web response system to mogamulizumab', 'Mogamulizumab therapy', 'mogamulizumab', 'Mogamulizumab versus vorinostat']","['superior investigator-assessed progression-free survival', 'pulmonary embolism', 'progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026948', 'cui_str': 'Mycosis Fungoides'}, {'cui': 'C0036920', 'cui_str': ""Sezary's Lymphoma""}, {'cui': 'C0763273', 'cui_str': 'AT61 cpd'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1521895', 'cui_str': 'Principal investigator (occupation)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0079773', 'cui_str': 'Lymphoma, T-Cell, Cutaneous'}]","[{'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C2987603', 'cui_str': 'mogamulizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}]",370.0,0.186534,"Mogamulizumab therapy resulted in superior investigator-assessed progression-free survival compared with vorinostat therapy (median 7·7 months [95% CI 5·7-10·3] in the mogamulizumab group vs 3·1 months [2·9-4·1] in the vorinostat group; hazard ratio 0·53, 95% CI 0·41-0·69; stratified log-rank p<0·0001).","[{'ForeName': 'Youn H', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Stanford University, Stanford, CA, USA. Electronic address: younkim@stanford.edu.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Bagot', 'Affiliation': 'Hôpital Saint Louis, APHP, Inserm U976, Université Paris 7, Paris, France.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Pinter-Brown', 'Affiliation': 'University of California Irvine, Irvine, CA, USA.'}, {'ForeName': 'Alain H', 'Initials': 'AH', 'LastName': 'Rook', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Porcu', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Horwitz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Whittaker', 'Affiliation': ""Guy's and St Thomas' Hospital, London, UK.""}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Tokura', 'Affiliation': 'Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Vermeer', 'Affiliation': 'Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology ""Seràgnoli"", University of Bologna, Bologna, Italy.'}, {'ForeName': 'Lubomir', 'Initials': 'L', 'LastName': 'Sokol', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': ""Guy's and St Thomas' Hospital, London, UK.""}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Pablo L', 'Initials': 'PL', 'LastName': 'Ortiz-Romero', 'Affiliation': 'Department of Dermatology, Institute i+12, Hospital 12 de Octubre Medical School, University Complutense, Madrid, Spain.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Eradat', 'Affiliation': 'UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Scarisbrick', 'Affiliation': 'University Hospital Birmingham, Birmingham, UK.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Tsianakas', 'Affiliation': 'University Hospital MÜnster, MÜnster, Germany.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Elmets', 'Affiliation': 'University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon, Claude Bernard Lyon 1 University, Lyon, France.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Fisher', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Halwani', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Poligone', 'Affiliation': 'Rochester Skin Lymphoma Center, Fairport, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Greer', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Fierro', 'Affiliation': 'University of Turin, Turin, Italy.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Khot', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Moskowitz', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Musiek', 'Affiliation': 'Washington University, St Louis, MO, USA.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Shustov', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pro', 'Affiliation': 'Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Larisa J', 'Initials': 'LJ', 'LastName': 'Geskin', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dwyer', 'Affiliation': 'Kyowa Kirin Pharmaceutical Development, Princeton, NJ, USA.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Moriya', 'Affiliation': 'Kyowa Kirin Pharmaceutical Development, Princeton, NJ, USA.'}, {'ForeName': 'Mollie', 'Initials': 'M', 'LastName': 'Leoni', 'Affiliation': 'Kyowa Kirin Pharmaceutical Development, Princeton, NJ, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Humphrey', 'Affiliation': 'Kyowa Kirin Pharmaceutical Development, Princeton, NJ, USA.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Hudgens', 'Affiliation': 'Clinical Outcome Solutions, Tucson, AZ, USA.'}, {'ForeName': 'Dmitri O', 'Initials': 'DO', 'LastName': 'Grebennik', 'Affiliation': 'Kyowa Kirin Pharmaceutical Development, Princeton, NJ, USA.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Duvic', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30379-6']
781,30100379,"Sorafenib plus topotecan versus placebo plus topotecan for platinum-resistant ovarian cancer (TRIAS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


Antiangiogenic therapy has known activity in ovarian cancer. The investigator-initiated randomised phase 2 TRIAS trial assessed the multi-kinase inhibitor sorafenib combined with topotecan and continued as maintenance therapy for platinum-resistant or platinum-refractory ovarian cancer.
METHODS


We did a multicentre, double-blind, placebo-controlled, randomised, phase 2 trial at 20 sites in Germany. Patients (≥18 years) with platinum-resistant ovarian cancer previously treated with two or fewer chemotherapy lines for recurrent disease were stratified (first vs later relapse) in block sizes of four and randomly assigned (1:1) using a web-generated response system to topotecan (1·25 mg/m 2  on days 1-5) plus either oral sorafenib 400 mg or placebo twice daily on days 6-15, repeated every 21 days for six cycles, followed by daily maintenance sorafenib or placebo for up to 1 year in patients without progression. Investigators and patients were masked to allocation of sorafenib or placebo; topotecan treatment was open label. The primary endpoint was investigator-assessed progression-free survival, analysed in all patients who received at least one dose of study drug. This completed trial is registered with ClinicalTrials.gov, number NCT01047891.
FINDINGS


Between Jan 18, 2010, and Sept 19, 2013, 185 patients were enrolled, 174 of whom were randomly assigned: 85 to sorafenib and 89 to placebo. Two patients in the sorafenib group had serious adverse events before treatment and were excluded from analyses. 83 patients in the sorafenib group and 89 in the placebo group started treatment. Progression-free survival was significantly improved with sorafenib versus placebo (hazard ratio 0·60, 95% CI 0·43-0·83; p=0·0018). Median progression-free survival was 6·7 months (95% CI 5·8-7·6) with sorafenib versus 4·4 months (3·7-5·0) with placebo. The most common grade 3-4 adverse events were leucopenia (57 [69%] of 83 patients in the sorafenib group vs 47 [53%] of 89 in the placebo group), neutropenia (46 [55%] vs 48 [54%]), and thrombocytopenia (23 [28%] vs 20 [22%]). Serious adverse events occurred in 49 (59%) of 83 sorafenib-treated patients and 45 (51%) of 89 placebo-treated patients. Of these, events were fatal in four patients (5%) in the sorafenib group (dyspnoea and poor general condition, septic shock, ascites and dyspnoea, and sigma perforation) and seven (8%) in the placebo group (pulmonary embolism in two patients, disease progression in two patients, and one case each of sepsis with fever, pleural effusion, and tumour cachexia). Sorafenib was associated with increased incidences of grade 3 hand-foot skin reaction (three [13%] vs 0 patients) and grade 2 alopecia (24 [29%] vs 12 [13%]).
INTERPRETATION


Sorafenib, when given orally in combination with topotecan and continued as maintenance therapy, showed a statistically and clinically significant improvement in progression-free survival in women with platinum-resistant ovarian cancer. These encouraging results support the crucial role of antiangiogenesis as the treatment backbone in combination with chemotherapy, making this approach attractive for further assessment with other targeted strategies.
FUNDING


Bayer, Amgen, and GlaxoSmithKline.",2018,"Progression-free survival was significantly improved with sorafenib versus placebo (hazard ratio 0·60, 95% CI 0·43-0·83; p=0·0018).","['Patients (≥18 years) with platinum-resistant ovarian cancer previously treated with two or fewer chemotherapy lines for recurrent disease were stratified (first vs later relapse) in block sizes of four and randomly assigned (1:1) using a', '83 patients in the sorafenib group and 89 in the', 'platinum-resistant ovarian cancer (TRIAS', 'Between Jan 18, 2010, and Sept 19, 2013, 185 patients were enrolled, 174 of whom were randomly assigned: 85 to', 'ovarian cancer', '20 sites in Germany', 'women with platinum-resistant ovarian cancer']","['Sorafenib plus topotecan', 'sorafenib or placebo; topotecan', 'placebo', 'Sorafenib', 'sorafenib combined with topotecan', 'sorafenib', 'placebo plus topotecan', 'web-generated response system to topotecan (1·25 mg/m 2  on days 1-5) plus either oral sorafenib 400 mg or placebo', 'Antiangiogenic therapy', 'sorafenib or placebo']","['disease progression', 'Progression-free survival', 'serious adverse events', 'progression-free survival', 'neutropenia', 'grade 2 alopecia', 'incidences of grade 3 hand-foot skin reaction', 'leucopenia', 'investigator-assessed progression-free survival', 'dyspnoea and poor general condition, septic shock, ascites and dyspnoea, and sigma perforation', 'Median progression-free survival', 'Serious adverse events', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease (disorder)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}]","[{'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",185.0,0.773061,"Progression-free survival was significantly improved with sorafenib versus placebo (hazard ratio 0·60, 95% CI 0·43-0·83; p=0·0018).","[{'ForeName': 'Radoslav', 'Initials': 'R', 'LastName': 'Chekerov', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany; Berlin Institute of Health, Department of Gynecology with Center for Oncological Surgery, Berlin, Germany. Electronic address: radoslav.chekerov@charite.de.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': 'Gynecologic Oncology Center at Jerusalem Hospital, Hamburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital, Ludwig-Maximilians-University, Munich, Germany; Department of Gynecology, University Medical Center Hamburg Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Balat', 'Affiliation': 'Department of Gynecology and Obstetrics, University of Frankfurt am Main, Frankfurt am Main, Germany; Department of Gynecology and Gynecologic Oncology, HSK Dr Horst-Schmidt-Kliniken, Wiesbaden, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'De Gregorio', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Fridrich', 'Affiliation': 'Department of Gynecology and Cancer Center, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Markmann', 'Affiliation': 'Frauenarztpraxis, Rostock, Germany; Department of Gynecology and Obstetrics, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'Potenberg', 'Affiliation': 'Department of Hematology, Waldkrankenhaus Spandau, Berlin, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Lorenz', 'Affiliation': 'Gynecologic Oncology, Gemeinschaftspraxis, Braunschweig, Germany.'}, {'ForeName': 'Guelten', 'Initials': 'G', 'LastName': 'Oskay-Oezcelik', 'Affiliation': 'Praxisklinik Krebsheilkunde, Berlin, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'Department of Obstetrics and Gynecology, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Krabisch', 'Affiliation': 'Gynecologic Oncology, Klinikum Chemnitz, Chemnitz, Germany.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Lueck', 'Affiliation': 'Gynecologic Oncology, Gyn-Onko Hannover, Hannover, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Richter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany; Berlin Institute of Health, Department of Gynecology with Center for Oncological Surgery, Berlin, Germany.'}, {'ForeName': 'Elena Ioana', 'Initials': 'EI', 'LastName': 'Braicu', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany; Berlin Institute of Health, Department of Gynecology with Center for Oncological Surgery, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany; Berlin Institute of Health, Department of Gynecology with Center for Oncological Surgery, Berlin, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30372-3']
782,30074327,Effects of adding different doses of clonidine to intrathecal bupivacaine for spinal anesthesia in cesarean section.,"PURPOSE


This study investigated the effects of three different doses of clonidine in combination with intrathecal hyperbaric bupivacaine on the quality of the blockade and maternal-fetal repercussions in parturients undergoing elective cesarean section. Materials an Methods: Following ethics committee approval, ASA I and II patients of age group 20-35 years, scheduled for cesarean section, were chosen for this study. Patients were randomly distributed into three equal groups of 35 patients in each using a computer-generated sequence of numbers. The patients received hyperbaric bupivacaine (two ml) with 15 gg of clonidine (BC15 group) or 30 jig of clonidine (BC30 group) or 60 μg of clonidine (BC60 group). Hemodynamic parameters, onset, peak and duration of sensory and motor block, sedation scores, Apgar scores, side effects, and duration of postoperative analgesia were compared.
RESULTS


All groups were comparable with respect to demographic profile, onset, peak and duration of sensory and motor block, and overall hemodynamic stability. The authors observed dose-dependent variability in duration of analgesia and sedation. Duration of analgesia was significantly higher in BC60 group as compared to the other two groups (577.13 ± 120.30 vs. 422.06 ± 112.47 and 376.21 ± 87.21 minutes, respectively). Sedation was also more in BC 60 group.
CONCLUSION


Intrathecal addition of 15 and 30 μg clonidine are better options when sedation is not desirable; on the contrary, addition of 60 pg provides excellent quality of spinal analgesia when some amount of sedation is acceptable or required without any deleterious effects on the mother and baby.",2016,"All groups were comparable with respect to demographic profile, onset, peak and duration of sensory and motor block, and overall hemodynamic stability.","['parturients undergoing elective cesarean section', 'spinal anesthesia in cesarean section']","['clonidine (BC15 group) or 30 jig of clonidine (BC30 group) or 60 μg of clonidine (BC60 group', 'hyperbaric bupivacaine', 'clonidine', 'intrathecal hyperbaric bupivacaine', 'clonidine to intrathecal bupivacaine']","['Sedation', 'demographic profile, onset, peak and duration of sensory and motor block, and overall hemodynamic stability', 'duration of analgesia and sedation', 'Hemodynamic parameters, onset, peak and duration of sensory and motor block, sedation scores, Apgar scores, side effects, and duration of postoperative analgesia', 'quality of the blockade and maternal-fetal repercussions', 'Duration of analgesia']","[{'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",,0.0604701,"All groups were comparable with respect to demographic profile, onset, peak and duration of sensory and motor block, and overall hemodynamic stability.","[{'ForeName': 'Zhi-Gao', 'Initials': 'ZG', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Qian', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
783,29694685,"Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density: A Randomized, Double-Blind, Phase 2, Parallel Group Study.","Over 12 months, romosozumab increased bone formation and decreased bone resorption, resulting in increased bone mineral density (BMD) in postmenopausal women with low BMD (NCT00896532). Herein, we report the study extension evaluating 24 months of treatment with romosozumab, discontinuation of romosozumab, alendronate followed by romosozumab, and romosozumab followed by denosumab. Postmenopausal women aged 55 to 85 years with a lumbar spine (LS), total hip (TH), or femoral neck T-score ≤-2.0 and ≥-3.5 were enrolled and randomly assigned to placebo, one of five romosozumab regimens (70 mg, 140 mg, 210 mg monthly [QM]; 140 mg Q3M; 210 mg Q3M) for 24 months, or open-label alendronate for 12 months followed by romosozumab 140 mg QM for 12 months. Eligible participants were then rerandomized 1:1 within original treatment groups to placebo or denosumab 60 mg Q6M for an additional 12 months. Percentage change from baseline in BMD and bone turnover markers (BTMs) at months 24 and 36 and safety were evaluated. Of 364 participants initially randomized to romosozumab, placebo, or alendronate, 315 completed 24 months of treatment and 248 completed the extension. Romosozumab markedly increased LS and TH BMD through month 24, with largest gains observed with romosozumab 210 mg QM (LS = 15.1%; TH = 5.4%). Women receiving romosozumab who transitioned to denosumab continued to accrue BMD, whereas BMD returned toward pretreatment levels with placebo. With romosozumab 210 mg QM, bone formation marker P1NP initially increased after treatment initiation and gradually decreased to below baseline by month 12, remaining below baseline through month 24; bone resorption marker β-CTX rapidly decreased after treatment, remaining below baseline through month 24. Transition to denosumab further decreased both BTMs, whereas after transition to placebo, P1NP returned to baseline and β-CTX increased above baseline. Adverse events were balanced between treatment groups through month 36. These data suggest that treatment effects of romosozumab are reversible upon discontinuation and further augmented by denosumab. © 2018 The Authors Journal of Bone and Mineral Research published by Wiley Periodicals, Inc.",2018,"Over 12 months, romosozumab increased bone formation and decreased bone resorption, resulting in increased bone mineral density (BMD) in postmenopausal women with low BMD (NCT00896532).","['postmenopausal women with low BMD (NCT00896532', 'Postmenopausal women aged 55 to 85 years with a lumbar spine (LS), total hip (TH), or femoral neck T-score ≤-2.0 and ≥-3.5', '364 participants initially randomized to', 'Eligible participants', 'Postmenopausal Women With Low Bone Mineral Density']","['placebo', 'romosozumab', 'open-label alendronate', 'romosozumab 140\u2009mg QM', 'romosozumab regimens (70\u2009mg, 140\u2009mg, 210\u2009mg monthly [QM', 'placebo or denosumab 60\u2009mg Q6M', 'Romosozumab', 'Denosumab or Placebo', 'romosozumab, placebo, or alendronate', 'romosozumab, discontinuation of romosozumab, alendronate followed by romosozumab, and romosozumab followed by denosumab']","['LS and TH BMD', 'Adverse events', 'BMD', 'bone formation marker P1NP', 'bone resorption marker β-CTX', 'BMD and bone turnover markers (BTMs', 'bone formation and decreased bone resorption', 'bone mineral density (BMD']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3661283'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",364.0,0.246241,"Over 12 months, romosozumab increased bone formation and decreased bone resorption, resulting in increased bone mineral density (BMD) in postmenopausal women with low BMD (NCT00896532).","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, Portland, OR, USA.'}, {'ForeName': 'Jacques P', 'Initials': 'JP', 'LastName': 'Brown', 'Affiliation': 'Laval University and CHU de Québec Research Centre, Quebec City, QC, Canada.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Diez-Perez', 'Affiliation': 'Medicine Hospital del Mar/IMIM, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Heinrich', 'Initials': 'H', 'LastName': 'Resch', 'Affiliation': 'St Vincent Hospital, Vienna, Austria.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Caminis', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Meisner', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bolognese', 'Affiliation': 'Bethesda Health Research Center, Bethesda, MD, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Goemaere', 'Affiliation': 'Ghent University Hospital, Gent, Belgium.'}, {'ForeName': 'Henry G', 'Initials': 'HG', 'LastName': 'Bone', 'Affiliation': 'Michigan Bone and Mineral Clinic, Detroit, MI, USA.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Zanchetta', 'Affiliation': 'Instituto de Investigaciones Metabólicas, Buenos Aires, Argentina.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Maddox', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bray', 'Affiliation': 'Amgen Ltd., Cambridge, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3452']
784,30012273,Smartphone-based screening for visual impairment in Kenyan school children: a cluster randomised controlled trial.,"BACKGROUND


Childhood visual impairment is a major public health concern that requires effective screening and early intervention. We investigated the effectiveness of Peek school eye health, a smartphone-based sight test and referral system (comprising Peek Acuity test, sight simulation referral cards, and short message service [SMS] reminders), versus standard care (Snellen's Tumbling-E card and written referral).
METHODS


We initially compared the performance of both the Snellen Tumbling-E card and the Peek Acuity test to a standard backlit EDTRS LogMAR visual acuity test chart. We did a cluster randomised controlled trial to compare the Peek school eye health system with standard school screening care, delivered by school teachers. Schools in Trans Nzoia County, Kenya, were eligible if they did not have an active screening programme already in place. Schools were randomly allocated (1:1) to either the Peek school eye health screening and referral programmes (Peek group) or the standard care screening and referral programme (standard group). In both groups, teachers tested vision of children in years 1-8. Pupils with visual impairment (defined as vision less than 6/12 in either eye) were referred to hospital for treatment. Referred children from the standard group received a written hospital referral letter. Participants and their teachers in the Peek group were shown their simulated sight on a smartphone and given a printout of this simulation with the same hospital details as the standard referral letter to present to their parent or guardian. They also received regular SMS reminders to attend the hospital. The primary outcome was the proportion of referred children who reported to hospital within 8 weeks of referral. Primary analysis was by intention to treat, with the intervention effect estimated using odds ratios. This trial is registered with Pan African Clinical Trial Registry, number PACTR201503001049236.
FINDINGS


Sensitivity was similar for the Peek test and the standard test (77% [95% CI 64·8-86·5] vs 75% [63·1-85·2]). Specificity was lower for the Peek test than the standard test (91% [95% CI 89·3-92·1] vs 97·4% [96·6-98·1]). Trial recruitment occurred between March 2, 2015, and March 13, 2015. Of the 295 eligible public primary schools in Trans Nzoia County, 50 schools were randomly selected and assigned to either the Peek group (n=25) or the standard group (n=25). 10 579 children were assessed for visual impairment in the Peek group and 10 284 children in the standard group. Visual impairment was identified in 531 (5%) of 10 579 children in the Peek group and 366 (4%) of 10 284 children in the standard care group. The proportion of pupils identified as having visual impairment who attended their hospital referral was significantly higher in the Peek group (285 [54%] of 531) than in the standard group (82 [22%] of 366; odds ratio 7·35 [95% CI 3·49-15·47]; p<0·0001).
INTERPRETATION


The Peek school eye health system increased adherence to hospital referral for visual impairment assessment compared with the standard approach among school children. This indicates the potential of this technology package to improve uptake of services and provide real-time visibility of health service delivery to help target resources.
FUNDING


Seeing is Believing, Operation Eyesight Universal, Queen Elizabeth Diamond Jubilee Trust, and Wellcome Trust.",2018,Specificity was lower for the Peek test than the standard test (91% [95% CI 89·3-92·1] vs 97·4% [96·6-98·1]).,"['10\u2008579 children', 'Schools in Trans Nzoia County, Kenya, were eligible if they did not have an active screening programme already in place', 'Kenyan school children', '295 eligible public primary schools in Trans Nzoia County, 50 schools', 'Pupils with visual impairment (defined as vision less than 6/12 in either eye) were referred to hospital for treatment', 'school children']","[""Peek school eye health, a smartphone-based sight test and referral system (comprising Peek Acuity test, sight simulation referral cards, and short message service [SMS] reminders), versus standard care (Snellen's Tumbling-E card and written referral"", 'Peek school eye health system with standard school screening care, delivered by school teachers', 'Smartphone-based screening', 'Peek school eye health screening and referral programmes (Peek group) or the standard care screening and referral programme (standard group', 'written hospital referral letter']","['Specificity', 'proportion of pupils identified as having visual impairment who attended their hospital referral', 'Visual impairment', 'visual impairment', 'proportion of referred children who reported to hospital within 8 weeks of referral']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0337839', 'cui_str': 'Kenyans (ethnic group)'}, {'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0442752', 'cui_str': '6/12'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0019982', 'cui_str': 'Hospital Referral'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3178909'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0036374', 'cui_str': 'School Teachers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019982', 'cui_str': 'Hospital Referral'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019982', 'cui_str': 'Hospital Referral'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]",10579.0,0.153117,Specificity was lower for the Peek test than the standard test (91% [95% CI 89·3-92·1] vs 97·4% [96·6-98·1]).,"[{'ForeName': 'Hillary K', 'Initials': 'HK', 'LastName': 'Rono', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK; Kitale County and Referral Hospital, Kitale, Kenya. Electronic address: hillary.rono@lshtm.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bastawrous', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK; The Peek Vision Foundation, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Wanjala', 'Affiliation': 'Kitale County and Referral Hospital, Kitale, Kenya.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Di Tanna', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'International Centre for Eye Health, Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK; Cornea and External Eye Department, Moorfields Eye Hospital NHS Trust, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30244-4']
785,30012268,Exposure to improved nutrition from conception to age 2 years and adult cardiometabolic disease risk: a modelling study.,"BACKGROUND


Low-income and middle-income countries with populations that are chronically undernourished in early life are undergoing a nutrition transition and are experiencing an epidemic of cardiometabolic disease. These dual burdens are thought to be causally related; therefore, the extent to which improvements in early-life nutrition can offset adult-onset disease is important. The aim of this study was to examine whether improvement of protein-energy nutrition from conception to age 2 years can attenuate the risk of cardiometabolic disease.
METHODS


We followed up a cohort of 2392 individuals born between Jan 1, 1962, and Feb 28, 1977, in four villages in Guatemala who had participated in a cluster-randomised protein-energy nutritional supplementation (Atole) trial. Of 1661 participants available for follow-up from Feb 26, 2015, to April 29, 2017, we studied 684 women and 455 men. We assessed cardiometabolic disease risk at ages 37-54 years using anthropometry, fasting and post-challenge glucose, fasting lipid concentrations, and blood pressure. We used generalised linear and logistic regression modelling to estimate the effect of Atole from conception to age 2 years (the first 1000 days) on cardiometabolic disease risk.
FINDINGS


Exposure to Atole from conception to age 2 years was associated with increased fatness (body-mass index [1·29 kg/m 2 , 95% CI 0·08 to 2·50], body fat [1·73%, 0·20 to 3·26], and obesity [odds ratio 1·94, 1·11 to 3·40]), diastolic blood pressure (1·59 mm Hg, -0·74 to 3·92), and blood lipids (total cholesterol [10·10 mg/dL, 0·80 to 19·40] and non-HDL cholesterol [10·41 mg/dL, 1·51 to 19·31]), reduced post-challenge glucose (-5·84 mg/dL, -12·51 to 0·83), and reduced odds of diabetes (odds ratio 0·46, 0·21 to 0·97). We found stratum heterogeneity by sex in pooled models for non-HDL cholesterol (4·34 mg/dL, 95% CI -6·86 to 15·55 for women vs 19·84 mg/dL, 5·86 to 33·82 for men) and post-challenge glucose (-0·19 mg/dL, -8·63 to 8·24 for women vs -13·10 mg/dL, -23·64 to -2·56 for men). p values for interaction of sex and exposure to Atole from conception to age 2 years were 0·09 and 0·04, respectively.
INTERPRETATION


Improved protein-energy nutrition from conception to the 2nd birthday reduced the odds of diabetes at ages 37-54 years; however, this protein-energy supplementation also increased the risk of obesity and several obesity-related conditions. Our findings suggest a mixed ability of protein-energy nutritional supplementation in early life to prevent adult cardiometabolic disease incidence in the context of high childhood stunting and high adult overweight and obesity.
FUNDING


National Institutes of Health.",2018,"reduced post-challenge glucose (-5·84 mg/dL, -12·51 to 0·83), and reduced odds of diabetes (odds ratio 0·46, 0·21 to 0·97).","['at ages 37-54 years using anthropometry, fasting and post-challenge glucose, fasting lipid concentrations, and blood pressure', '2392 individuals born between Jan 1, 1962, and Feb 28, 1977, in four villages in Guatemala who had participated in a cluster-randomised protein-energy nutritional supplementation (Atole) trial', '1661 participants available for follow-up from Feb 26, 2015, to April 29, 2017, we studied 684 women and 455 men']","['non-HDL cholesterol [10·41 mg/dL, 1·51 to 19·31', 'protein-energy nutritional supplementation']","['blood lipids (total cholesterol', 'diastolic blood pressure', 'cardiometabolic disease risk']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}]","[{'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",684.0,0.0303925,"reduced post-challenge glucose (-5·84 mg/dL, -12·51 to 0·83), and reduced odds of diabetes (odds ratio 0·46, 0·21 to 0·97).","[{'ForeName': 'Nicole D', 'Initials': 'ND', 'LastName': 'Ford', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jere R', 'Initials': 'JR', 'LastName': 'Behrman', 'Affiliation': 'Departments of Economics and Sociology, School of Arts and Sciences, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Hoddinott', 'Affiliation': 'Division of Nutritional Sciences and Charles H Dyson School of Applied Economics and Management, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Maluccio', 'Affiliation': 'Department of Economics, Middlebury College, Middlebury, VT, USA.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramirez-Zea', 'Affiliation': 'Institute of Nutrition of Central America and Panama Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, GA, USA. Electronic address: aryeh.stein@emory.edu.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30231-6']
786,29944242,"Effects of estradiol injection on outcome of in-vitro fertilization: a randomized, double-blind, placebo controlled trial.","PURPOSE


To evaluate the effects of estradiol (E2) supplementation on pregnancy outcome in patients with unexplained infertility undergoing in vitro fertilization (IVF).
MATERIALS AND METHODS


A total of 100 women with unexplained infertility and candidates for IVF, were included in this study and were randomly assigned to receive E2 supplementation or placebo during the luteal phase. The E2 serum levels in the hCG administration day and third and seventh day after ovum retrieval were measured in control group. The rate of pregnancy was also quantified and compared between the two study groups.
RESULTS


There was no significant difference between two study groups regarding baseline characteristics. E2 level decreased significantly in third (1765.34 ± 680.09; p < 0.001) and seventh (1459.66 ± 593.80; p < 0.001) days after ovum retrieval (2411.16 ± 713.52). The authors found that the serum level of E2 was significantly lower in those who received E2 supplementation at day 3 (p < 0.001) and 7 (p<0.001). However the pregnancy rate was not significantly different between two study groups (p = 0.849). In the same way, there was no significant difference between two study groups regarding the number of retrieved oocytes (p = 0.563) and number of MII oocytes (p = 0.103).
CONCLUSIONS


E2 supplementation during the luteal phase in patients with unexplained infertility undergoing IVF, is associated with decreased serum levels of E2 after hCG injection. However the fertility outcome was not affected by E2 supplementation.",2016,E2 level decreased significantly in third (1765.34 ± 680.09; p < 0.001) and seventh (1459.66 ± 593.80; p < 0.001) days after ovum retrieval (2411.16 ± 713.52).,"['patients with unexplained infertility undergoing IVF', '100 women with unexplained infertility and candidates for IVF', 'patients with unexplained infertility undergoing in vitro fertilization (IVF']","['placebo', 'estradiol injection', 'E2 supplementation or placebo', 'E2 supplementation', 'estradiol (E2) supplementation']","['pregnancy outcome', 'pregnancy rate', 'E2 level', 'number of retrieved oocytes', 'number of MII oocytes', 'E2 serum levels', 'outcome of in-vitro fertilization', 'fertility outcome', 'rate of pregnancy', 'serum level of E2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",100.0,0.550027,E2 level decreased significantly in third (1765.34 ± 680.09; p < 0.001) and seventh (1459.66 ± 593.80; p < 0.001) days after ovum retrieval (2411.16 ± 713.52).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Samsami', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zarei', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shahrivar', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
787,30340895,"Plasma citrulline concentration, a marker for intestinal functionality, reflects exercise intensity in healthy young men.","BACKGROUND & AIMS


Plasma citrulline concentration is considered to be a marker for enterocyte metabolic mass and to reflect its reduction as may occur during intestinal dysfunction. Strenuous exercise can act as a stressor to induce small intestinal injury. Our previous studies suggest that this comprises the intestinal ability to produce citrulline from a glutamine-rich protein bolus. In this study we investigated the effects of different exercise intensities and hydration state on citrulline and iFABP levels following a post-exercise glutamine bolus in healthy young men.
METHODS


Fifteen healthy young men (20-35 yrs, VO 2  max 56.9 ± 3.9 ml kg -1  min -1 ) performed in a randomly assigned cross-over design, a rest (protocol 1) and four cycle ergometer protocols. The volunteers cycled submaximal at different percentages of their individual pre-assessed maximum workload (Wmax): 70% Wmax in hydrated (protocol 2) and dehydrated state (protocol 3), 50% Wmax (protocol 4) and intermittent 85/55% Wmax in blocks of 2 min (protocol 5). Immediately after 1 h exercise or rest, subjects were given a glutamine bolus with added alanine as an iso-caloric internal standard (7.5 g of each amino acid). Blood samples were collected before, during and after rest or exercise, up to 24 h post onset of the experiment. Amino acids and urea were analysed as metabolic markers, creatine phosphokinase and iFABP as markers of muscle and intestinal damage, respectively. Data were analysed using a multilevel mixed linear statistical model. p values were corrected for multiple testing.
RESULTS


Citrulline levels already increased before glutamine supplementation during normal hydrated exercise, while this was not observed in the dehydrated and rest protocols. The low intensity exercise protocol (50% Wmax) showed the highest increase in citrulline levels both during exercise (43.83 μmol/L ± 2.63 (p < 0.001)) and after glutamine consumption (50.54 μmol/L ± 2.62) compared to the rest protocol (28.97 μmol/L ± 1.503 and 41.65 μmol/L ± 1.96, respectively, p < 0.05). However, following strenuous exercise at 70% Wmax in the dehydrated state, citrulline levels did not increase during exercise and less after the glutamine consumption when compared to the resting condition and hydrated protocols. In line with this, serum iFABP levels were the highest with the strenuous dehydrated protocol (1443.72 μmol/L ± 249.9, p < 0.001), followed by the high intensity exercise at 70% Wmax in the hydrated condition.
CONCLUSIONS


Exercise induces an increase in plasma citrulline, irrespective of a glutamine bolus. The extent to which this occurs is dependent on exercise intensity and the hydration state of the subjects. The same holds true for both the post-exercise increase in citrulline levels following glutamine supplementation and serum iFABP levels. These data indicate that citrulline release during exercise and after an oral glutamine bolus might be dependent on the intestinal health state and therefore on intestinal functionality. Glutamine is known to play a major role in intestinal physiology and the maintenance of gut health and barrier function. Together, this suggests that in clinical practice, a glutamine bolus to increase citrulline levels after exercise might be preferable compared to supplementing citrulline itself. To our knowledge this is the first time that exercise workload-related effects on plasma citrulline are reported in relation to intestinal damage.",2019,"The low intensity exercise protocol (50% Wmax) showed the highest increase in citrulline levels both during exercise (43.83 μmol/L ± 2.63 (p < 0.001)) and after glutamine consumption (50.54 μmol/L ± 2.62) compared to the rest protocol (28.97 μmol/L ± 1.503 and 41.65 μmol/L ± 1.96, respectively, p < 0.05).","['Fifteen healthy young men (20-35\xa0yrs, VO 2  max 56.9\xa0±', 'healthy young men']","['exercise intensities and hydration state', 'individual pre-assessed maximum workload (Wmax): 70% Wmax in hydrated (protocol 2) and dehydrated state (protocol 3), 50% Wmax (protocol 4) and intermittent 85/55% Wmax in blocks of 2\xa0min (protocol 5', 'glutamine bolus with added alanine as an iso-caloric internal standard', 'Strenuous exercise', 'Glutamine', 'exercise glutamine bolus']","['plasma citrulline', 'citrulline levels', 'citrulline and iFABP levels', 'serum iFABP levels', 'Citrulline levels', 'Plasma citrulline concentration']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",15.0,0.0531232,"The low intensity exercise protocol (50% Wmax) showed the highest increase in citrulline levels both during exercise (43.83 μmol/L ± 2.63 (p < 0.001)) and after glutamine consumption (50.54 μmol/L ± 2.62) compared to the rest protocol (28.97 μmol/L ± 1.503 and 41.65 μmol/L ± 1.96, respectively, p < 0.05).","[{'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Kartaram', 'Affiliation': 'Research Group Innovative Testing in Life Sciences and Chemistry, University of Applied Sciences Utrecht, The Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mensink', 'Affiliation': 'Division Human Nutrition, Wageningen University & Research, Wageningen, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Teunis', 'Affiliation': 'Research Group Innovative Testing in Life Sciences and Chemistry, University of Applied Sciences Utrecht, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Schoen', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Zeist, The Netherlands.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'Witte', 'Affiliation': 'Nutricia Research, Utrecht, The Netherlands.'}, {'ForeName': 'Lonneke', 'Initials': 'L', 'LastName': 'Janssen Duijghuijsen', 'Affiliation': 'Division Human Nutrition, Wageningen University & Research, Wageningen, The Netherlands.'}, {'ForeName': 'Martie', 'Initials': 'M', 'LastName': 'Verschuren', 'Affiliation': 'Research Group Analysis Techniques in the Life Sciences, Avans University of Applied Sciences, Breda, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mohrmann', 'Affiliation': 'SHL-group, Etten-Leur, The Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': ""M'Rabet"", 'Affiliation': 'Research Group Innovative Testing in Life Sciences and Chemistry, University of Applied Sciences Utrecht, The Netherlands.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Knipping', 'Affiliation': 'Nutricia Research, Utrecht, The Netherlands.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Wittink', 'Affiliation': 'Research Group Lifestyle and Health, University of Applied Sciences Utrecht, The Netherlands.'}, {'ForeName': 'Ardy', 'Initials': 'A', 'LastName': 'van Helvoort', 'Affiliation': 'Nutricia Research, Utrecht, The Netherlands; School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Garssen', 'Affiliation': 'Department of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands; Nutricia Research, Utrecht, The Netherlands.'}, {'ForeName': 'Renger', 'Initials': 'R', 'LastName': 'Witkamp', 'Affiliation': 'Division Human Nutrition, Wageningen University & Research, Wageningen, The Netherlands.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Pieters', 'Affiliation': 'Research Group Innovative Testing in Life Sciences and Chemistry, University of Applied Sciences Utrecht, The Netherlands; Institute for Risk Assessment Sciences, Immunotoxicology (IRAS), Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Klaske', 'Initials': 'K', 'LastName': 'van Norren', 'Affiliation': 'Division Human Nutrition, Wageningen University & Research, Wageningen, The Netherlands. Electronic address: klaske.vannorren@wur.nl.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.09.029']
788,30273288,Resistance Training Improves a Cellular Health Parameter in Obese Older Women: A Randomized Controlled Trial.,"Ribeiro, AS, Schoenfeld, BJ, dos Santos, L, Nunes, JP, Tomeleri, CM, Cunha, PM, Sardinha, LB, and Cyrino, ES. Resistance training improves a cellular health parameter in obese older women: a randomized controlled trial. J Strength Cond Res 34(10): 2996-3002, 2020-Phase angle (PhA) is a viable indicator of cellular health, with higher values reflecting better cellularity, cell membrane integrity, and cell function. Adaptive responses to resistance training (RT) on PhA may be important in obese older people. The main purpose of the present study was to investigate the effects of 8 weeks of RT on PhA in obese older women. Thirty-three obese older women (68.1 ± 5.7 years, 71.6 ± 10.1 kg, 154.5 ± 6.7 cm, 30.0 ± 4.1 kg·m, and 45.0 ± 6.0% body fat) were randomly allocated into 1 of 2 groups: a training group that performed the RT program (TG, n = 18) or a nonexercise control group (CG, n = 15). The whole-body RT consisted of an 8-week RT program involving 8 exercises performed for 3 sets of 8-12 repetitions 3 times a week. Anthropometric, body fat and fat-free mass, PhA, total body water (TBW), intracellular water (ICW), and extracellular water compartments were performed at before and after training. After the intervention period, the TG presented greater increases (p < 0.05) than CG for fat-free mass (TG = +1.3% and CG = -0.3%), TBW (TG = +2.0% and CG = -1.7%), ICW (TG = +3.1% and CG = -1.9%), and PhA (TG = +3.4% and CG = -1.4%), and lower values for percentage of body fat (TG = -1.3% and CG = +0.9%) and bioimpedance resistance (TG = -4.6% and CG = +2.3%). Our results suggest that 8 weeks of RT improves PhA-a cellular health parameter-in obese older women.",2020,"After the intervention period, the TG presented greater increases (p < 0.05) than CG for fat-free mass (TG = +1.3% and CG = -0.3%), TBW (TG = +2.0% and CG = -1.7%), ICW (TG = +3.1% and CG = -1.9%), and PhA (TG = +3.4% and CG = -1.4%), and lower values for percentage of body fat (TG = -1.3% and CG = +0.9%) and bioimpedance resistance (TG = -4.6% and CG = +2.3%).","['obese older women', 'obese older people', 'Obese Older Women', 'Thirty-three obese older women (68.1 ± 5.7 years, 71.6 ± 10.1 kg, 154.5 ± 6.7 cm, 30.0 ± 4.1 kg·m, and 45.0 ± 6.0% body fat']","['RT', 'training group that performed the RT program (TG, n = 18) or a nonexercise control', 'J Strength Cond Res XX(X', 'resistance training (RT', 'Resistance training', 'Resistance Training']","['ICW', 'Anthropometric, body fat and fat-free mass, PhA, total body water (TBW), intracellular water (ICW), and extracellular water compartments', 'Ribeiro, AS, Schoenfeld, BJ, dos Santos, L, Nunes, JP, Tomeleri, CM, Cunha, PM, Sardinha, LB, and Cyrino, ES', 'bioimpedance resistance', 'percentage of body fat']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}]",33.0,0.0228394,"After the intervention period, the TG presented greater increases (p < 0.05) than CG for fat-free mass (TG = +1.3% and CG = -0.3%), TBW (TG = +2.0% and CG = -1.7%), ICW (TG = +3.1% and CG = -1.9%), and PhA (TG = +3.4% and CG = -1.4%), and lower values for percentage of body fat (TG = -1.3% and CG = +0.9%) and bioimpedance resistance (TG = -4.6% and CG = +2.3%).","[{'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Ribeiro', 'Affiliation': 'Center for Research in Health Sciences, University of Northern Parana, Londrina, Brazil.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Exercise Science Department, CUNY Lehman College, Bronx, New York, NY.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Dos Santos', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Cunha', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Luis B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition, and Exercise Laboratory, Londrina State University, Londrina, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002773']
789,30273290,Effects of Lower-Body Muscular Fatigue on Vertical Jump and Balance Performance.,"Cooper, CN, Dabbs, NC, Davis, J, and Sauls, NM. Effects of lower-body muscular fatigue on vertical jump and balance performance. J Strength Cond Res 34(10): 2903-2910, 2020-Lower-body fatigue can lead to a decline in vertical jump (VJ) and balance performance due to decreased motor control and coordination. The purpose is to determine the effects of lower-body fatigue on VJ and balance performance. Twenty-four recreationally trained individuals participated in a single 1-hour familiarization and testing session. Participants were familiarized with balance, countermovement vertical jump (CMVJ), and static vertical jump (SVJ) using the Vertec. Three trials of static and dynamic balance tests were completed. Three trials of a SVJ and CMVJ were completed in a randomized order pre/post fatigue protocol. Three trials of double-leg and single-leg tests were performed. Dependent t tests analyzed differences between pre/post fatigue protocol for jumping and balance measures. There was a significant (p < 0.001) difference between pre/post measures for SVJ-H (height), CMVJ-H, and CMVJ peak power (PP). Results showed an interaction (p < 0.05) for group by time for CMVJ-H, CMVJ-peak force (PF), SVJ-PF, and SVJ-PP. There were no main effects (p > 0.05) for time or group for SVJ-rate of velocity development and SVJ-impact force (IF). There were no interactions, time effects, and group effects for balance variables (p > 0.05). Bosco protocol decreased VJ height and PF in SVJ, and VJ height and PF, IF, peak velocity, and PP for CMVJ potentially due to decreased muscle control, coordination, and force-generating capacity after fatigue. Practitioners should consider fatiguing effects on individuals performing jumping motions but it seems that fatigue has no effect on balance.",2020,There were no main effects (p > 0.05) for time or group for SVJ-rate of velocity development and SVJ-impact force (IF).,[' 000-000'],"['J Strength Cond Res XX(X', 'Lower-Body Muscular Fatigue', 'SVJ and CMVJ']","['vertical jump and balance performance', 'vertical jump (VJ) and balance performance', 'SVJ-rate of velocity development and SVJ-impact force (IF', 'time for CMVJ-H, CMVJ-peak force (PF), SVJ-PF, and SVJ-PP', 'VJ and balance performance', 'Vertical Jump and Balance Performance', 'SVJ-H (height), CMVJ-H, and CMVJ peak power (PP', 'VJ height and PF in SVJ, and VJ height and PF, IF, peak velocity, and PP for CMVJ potentially due to decreased muscle control, coordination, and force-generating capacity after fatigue', 'familiarized with balance, countermovement vertical jump (CMVJ), and static vertical jump (SVJ']",[],"[{'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0242979', 'cui_str': 'Muscular Fatigue'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}]",24.0,0.0267323,There were no main effects (p > 0.05) for time or group for SVJ-rate of velocity development and SVJ-impact force (IF).,"[{'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Cooper', 'Affiliation': 'Department of Kinesiology, Biomechanics and Sport Performance Laboratory, California State University, San Bernardino, San Bernardino, California.'}, {'ForeName': 'Nicole C', 'Initials': 'NC', 'LastName': 'Dabbs', 'Affiliation': ''}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Sauls', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002882']
790,30078935,Cantharidin is Superior to Trichloroacetic Acid for the Treatment of Non-mucosal Genital Warts: A Pilot Randomized Controlled Trial.,"Condyloma Acuminatum is a sexually transmitted viral disease caused by the human papilloma virus (HPV). It is the most common viral sexually transmitted disease. In this randomized controlled trial, cantharidin was found to be more effective and better tolerated than trichloroacetic acid for the treatment of these lesions. Patients treated with cantharidin healed with less scarring than those treated with TCA (P<0.034), had less pain during treatment (P<0.01), and required fewer treatments to eradicate warts (P<0.01) when compared to Trichloroacetic acid.",2018,"Patients treated with cantharidin healed with less scarring than those treated with TCA (P<0.034), had less pain during treatment (P<0.01), and required fewer treatments to eradicate warts (P<0.01) when compared to Trichloroacetic acid.",['Non-mucosal Genital Warts'],"['TCA', 'Trichloroacetic Acid', 'trichloroacetic acid', 'cantharidin']","['cantharidin healed with less scarring', 'pain']","[{'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}]","[{'cui': 'C0040900', 'cui_str': 'Trichloroacetic Acid'}, {'cui': 'C0006886', 'cui_str': 'Cantharidin'}]","[{'cui': 'C0006886', 'cui_str': 'Cantharidin'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0610352,"Patients treated with cantharidin healed with less scarring than those treated with TCA (P<0.034), had less pain during treatment (P<0.01), and required fewer treatments to eradicate warts (P<0.01) when compared to Trichloroacetic acid.","[{'ForeName': 'Maurice A', 'Initials': 'MA', 'LastName': 'Recanati', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit Medical Center.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Kramer', 'Affiliation': ""Department of Obstetrics and Gynecology, St. Vincent's Catholic Medical Centers, New York, NY.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Maggio', 'Affiliation': ""Department of Obstetrics and Gynecology, St. Vincent's Catholic Medical Centers, New York, NY.""}, {'ForeName': 'Conrad R', 'Initials': 'CR', 'LastName': 'Chao', 'Affiliation': 'Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.'}]",Clinical and experimental obstetrics & gynecology,['10.12891/ceog4112.2018']
791,30024481,"Acute Effects of Battle Rope Exercise on Performance, Blood Lactate Levels, Perceived Exertion, and Muscle Soreness in Collegiate Basketball Players.","Chen, WH, Yang, WW, Lee, YH, Wu, HJ, Huang, CF, and Liu, C. Acute effects of battle rope exercise on performance, blood lactate levels, perceived exertion, and muscle soreness in collegiate basketball players. J Strength Cond Res 34(10): 2857-2866, 2020-This study investigated the acute effects of battle rope (BR) exercise on basketball players' performance, blood lactate levels, rating of perceived exertion (RPE), and perceived muscle soreness. Fifteen well-trained Division-I male basketball players underwent the same test procedure at baseline, before BR exercise (30 minutes of rest after the baseline test), and after BR exercise. The 30-minute experimental protocol comprised 6 BR exercises at a work-to-rest ratio of 1:2 (20-second exercise and 40-second rest). Shooting accuracy, basketball chest pass speed, countermovement jump (CMJ) height, blood lactate levels, RPE (Borg Category-Ratio-10 scale), and perceived muscle soreness (visual analog scale, 0-100 mm) were measured in each test. The results indicated no change for any variables between baseline and before BR exercise. After BR exercise, performance decrements (p < 0.05) were recorded in shooting accuracy (16.9%) and basketball chest pass speed (9.1%), but no significant changes were observed for CMJ height. Battle rope exercise caused increases in blood lactate levels (13.6 mmol·L), RPE (9.9), and perceived muscle soreness (upper-limb: 63-67 mm; trunk: 43-68 mm; and lower-limb: 45-52 mm). In conclusion, BR exercise is physically demanding on the upper body, resulting in decreased performance in shooting accuracy and basketball chest pass speed. Battle rope exercise may not be beneficial before a practice or game because it triggers acute exercise-induced performance decrements and fatigue. However, BR exercise may be suitable for basketball training sessions in which the objective is to strengthen technical skills under fatiguing conditions.",2020,"Shooting accuracy, basketball chest pass speed, countermovement jump (CMJ) height, blood lactate levels, RPE (Borg Category-Ratio-10 scale), and perceived muscle soreness (visual analog scale, 0-100 mm) were measured in each test.","['Fifteen well-trained Division-I male basketball players', 'Collegiate Basketball Players']","['Battle rope exercise', 'J Strength Cond Res XX(X', 'battle rope (BR) exercise', 'Battle Rope Exercise', 'BR exercise']","[""basketball players' performance, blood lactate levels, rating of perceived exertion (RPE), and perceived muscle soreness"", 'Performance, Blood Lactate Levels, Perceived Exertion, and Muscle Soreness', 'performance, blood lactate levels, perceived exertion, and muscle soreness', 'muscle soreness', 'basketball chest pass speed', 'Shooting accuracy, basketball chest pass speed, countermovement jump (CMJ) height, blood lactate levels, RPE (Borg Category-Ratio-10 scale), and perceived muscle soreness (visual analog scale, 0-100 mm', 'shooting accuracy', 'CMJ height', 'blood lactate levels']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1444774', 'cui_str': 'Shooting'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]",,0.0376038,"Shooting accuracy, basketball chest pass speed, countermovement jump (CMJ) height, blood lactate levels, RPE (Borg Category-Ratio-10 scale), and perceived muscle soreness (visual analog scale, 0-100 mm) were measured in each test.","[{'ForeName': 'Wei-Han', 'Initials': 'WH', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Sports Equipment Technology, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Wen-Wen', 'Initials': 'WW', 'LastName': 'Yang', 'Affiliation': 'Graduate Institute of Sports Equipment Technology, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hua', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Ball Sports, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Huey-June', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Department of Combat Sports and Chinese Martial Arts, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Fu', 'Initials': 'CF', 'LastName': 'Huang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Chiang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Graduate Institute of Sports Equipment Technology, University of Taipei, Taipei, Taiwan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002661']
792,31647503,"Efficacy, Safety, and Tolerability of Pertuzumab, Trastuzumab, and Docetaxel for Patients With Early or Locally Advanced ERBB2-Positive Breast Cancer in Asia: The PEONY Phase 3 Randomized Clinical Trial.","Importance


Prospective assessment of treatments known to benefit patients in global clinical trials in specific racial groups is essential.
Objective


To compare the efficacy, safety, and tolerability of adding pertuzumab to trastuzumab and docetaxel vs placebo, trastuzumab, and docetaxel in Asian patients with ERBB2-positive early or locally advanced breast cancer.
Design, Setting, and Participants


This multicenter, double-blind, placebo-controlled phase 3 trial enrolled 329 women with ERBB2-positive early (T2-3, N0-1, M0) or locally advanced breast cancer (T2-3, N2 or N3, M0; T4, any N, M0) and primary tumor larger than 2 cm from March 14, 2016, to March 13, 2017. Analysis of the primary end point was performed on an intention-to-treat basis.
Interventions


Before surgery, patients received 4 cycles of intravenous pertuzumab (840-mg loading dose and 420-mg maintenance doses), trastuzumab (8-mg/kg loading dose and 6-mg/kg maintenance doses), and docetaxel (75 mg/m2) or intravenous placebo, trastuzumab, and docetaxel every 3 weeks. After surgery, patients received 3 cycles of intravenous fluorouracil, epirubicin, and cyclophosphamide followed by 13 cycles of the same intravenous anti-ERBB2 therapy (pertuzumab and trastuzumab or placebo and trastuzumab) for up to 1 year.
Main Outcomes and Measures


The primary end point was independent review committee-assessed total pathologic complete response rate. The 2-sided Cochran-Mantel-Haenszel test, stratified by disease category and hormone receptor status, was used to compare rates between treatment groups.
Results


In total, 329 female patients were randomized (pertuzumab, 219; and placebo, 110; mean [SD] age, 48.8 [9.5] years). In the intention-to-treat population, total pathologic complete response rates were 39.3% (86 of 219) in the pertuzumab group and 21.8% (24 of 110) in the placebo group (difference, 17.5% [95% CI, 6.9%-28.0%]; P = .001). Of the most common grade 3 or higher adverse events, there was a higher incidence of neutropenia in the pertuzumab group (83 of 218 [38.1%] vs 36 of 110 [32.7%]). Serious adverse events were reported in 10.1% of patients (22 of 218) in the pertuzumab group and 8.2% of patients (9 of 110) in the placebo group.
Conclusions and Relevance


Treatment with pertuzumab, trastuzumab, and docetaxel resulted in a statistically significant improvement in the total pathologic complete response rate vs placebo, trastuzumab, and docetaxel for the neoadjuvant treatment of ERBB2-positive early or locally advanced breast cancer in Asian patients. Safety data were in line with the known pertuzumab safety profile and generally comparable between treatment groups. The PEONY trial adds to the totality of data showing the benefit of the pertuzumab regimen.
Trial Registration


ClinicalTrials.gov identifier: NCT02586025.",2020,"Of the most common grade 3 or higher adverse events, there was a higher incidence of neutropenia in the pertuzumab group (83 of 218 [38.1%] vs 36 of 110 [32.7%]).","['Asian patients', 'Patients With Early or Locally Advanced ERBB2-Positive Breast Cancer in Asia', ' 110; mean [SD] age, 48.8 [9.5] years', 'Asian patients with ERBB2-positive early or locally advanced breast cancer', '329 women with ERBB2-positive early (T2-3, N0-1, M0) or locally advanced breast cancer (T2-3, N2 or N3, M0; T4, any N, M0) and primary tumor larger than 2 cm from March 14, 2016, to March 13, 2017', '329 female patients']","['trastuzumab (8-mg/kg loading dose and 6-mg/kg maintenance doses), and docetaxel', 'Pertuzumab, Trastuzumab, and Docetaxel', 'ERBB2 therapy (pertuzumab and trastuzumab or placebo and trastuzumab', 'intravenous fluorouracil, epirubicin, and cyclophosphamide', 'intravenous pertuzumab', 'placebo', 'placebo, trastuzumab, and docetaxel', 'pertuzumab to trastuzumab and docetaxel vs placebo, trastuzumab, and docetaxel', 'pertuzumab, trastuzumab, and docetaxel']","['efficacy, safety, and tolerability', 'total pathologic complete response rate', 'total pathologic complete response rates', 'neutropenia', 'Efficacy, Safety, and Tolerability', 'Serious adverse events', 'review committee-assessed total pathologic complete response rate']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}]",329.0,0.274601,"Of the most common grade 3 or higher adverse events, there was a higher incidence of neutropenia in the pertuzumab group (83 of 218 [38.1%] vs 36 of 110 [32.7%]).","[{'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Pang', 'Affiliation': 'Breast Surgery, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Hongjian', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Breast Surgery, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Medicine-Oncology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Medicine-Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Shude', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Breast Disease, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Liao', 'Affiliation': 'Department of Breast Disease, Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Breast Disease Center, Shandong Cancer Hospital, Jinan, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Breast Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Yuan-Ching', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Department of General Surgery, Mackay Memorial Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Hweichung', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, China Medical University Hospital, Taichung City, Taiwan.'}, {'ForeName': 'Seok Yun', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Jae Hong', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'Division of Oncology/Hematology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kunwei', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': 'Breast Disease Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Suphawat', 'Initials': 'S', 'LastName': 'Laohawiriyakamol', 'Affiliation': 'Department of Surgery, Songklanagarind Hospital, Songkhla, Thailand.'}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""Medicine-Oncology, The Affiliated Hospital of Military Medical Sciences (The 307th Hospital of Chinese People's Liberation Army), Beijing, China.""}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Biometrics, Roche Product Development, Shanghai, China.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Althaus', 'Affiliation': 'Product Development Oncology, Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Yixiang', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Roche Product Development, Shanghai, China.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Eng-Wong', 'Affiliation': 'Product Development Oncology, Genentech, Inc, South San Francisco, California.'}]",JAMA oncology,['10.1001/jamaoncol.2019.3692']
793,30470646,Low-dose Desmopressin Orally Disintegrating Tablet: Suggested Clinically Meaningful Benefit in Patients with Nocturia Due to Nocturnal Polyuria.,"BACKGROUND


Clinical benefit has not been evaluated much in patients with nocturia.
OBJECTIVE


To assess the clinical benefit of desmopressin orally disintegrating tablet (ODT) in women (25μg) and men (50μg) with nocturia due to nocturnal polyuria (NP).
DESIGN, SETTING, AND PATIENTS


Patients with NP from two randomised, placebo-controlled trials in men (CS41) and women (CS40) with two or more nocturnal voids per night were included.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Change from baseline in nocturnal voids, 33% and 50% responder status (average reduction of ≤33% and ≤50%, respectively, in the mean number of nocturnal voids vs baseline), and percentage of nights with at most one void or no voids (ie, complete response) during 3-mo treatment period were assessed for clinical benefit. Two-sided test (5% significance level) was used for all endpoints.
RESULTS AND LIMITATIONS


Demographics and baseline characteristics of patients in CS41 (N=230) and CS40 (N=232) were similar. A greater reduction in the mean number of nocturnal voids was seen with desmopressin ODT in men (treatment difference [TD]: -0.37 voids) compared with women (TD: -0.29 voids). For 33% and 50% responder status, TD with ODT versus placebo were 21% and 12%, respectively, in men, and 12% and 17%, respectively, in women. For the number of nights with at most one void, TDs were 11% and 13% (p<0.009 for both) for men and women, respectively. For complete response, TD was significant in men (TD: 9%, p<0.001). Limitations inherent in this analysis were evident as the data for cotreatments (baseline) and quality of life were not collected.
CONCLUSIONS


A stronger treatment effect with desmopressin ODT versus placebo and the magnitude of differences are indicative of clinical benefit in patients with NP.
PATIENT SUMMARY


We looked at the clinical benefit of desmopressin ODT in patients with nocturnal polyuria. We conclude that clinical benefit was observed with desmopressin ODT in these patients.",2020,A greater reduction in the mean number of nocturnal voids was seen with desmopressin ODT in men (treatment difference [TD]: -0.37 voids) compared with women (TD: -0.29 voids).,"['Patients with NP from two randomised, placebo-controlled trials in men (CS41) and women (CS40) with two or more nocturnal voids per night were included', 'Patients with Nocturia Due to Nocturnal Polyuria', 'patients with NP', 'patients with nocturia', 'patients with nocturnal polyuria', 'women (25μg) and men (50μg) with nocturia due to nocturnal polyuria (NP']","['placebo', 'Desmopressin Orally Disintegrating Tablet', 'desmopressin orally disintegrating tablet (ODT', 'desmopressin ODT', 'desmopressin ODT versus placebo']","['mean number of nocturnal voids', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0848232', 'cui_str': 'Nocturnal polyuria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0034380'}]",232.0,0.0983808,A greater reduction in the mean number of nocturnal voids was seen with desmopressin ODT in men (treatment difference [TD]: -0.37 voids) compared with women (TD: -0.29 voids).,"[{'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Weiss', 'Affiliation': 'Department of Urology, SUNY Downstate Medical School, Brooklyn, New York, USA.'}, {'ForeName': 'Egbert A', 'Initials': 'EA', 'LastName': 'van der Meulen', 'Affiliation': 'Ferring Pharmaceuticals, Copenhagen S, Denmark.'}, {'ForeName': 'Kristian Vinter', 'Initials': 'KV', 'LastName': 'Juul', 'Affiliation': 'Ferring Pharmaceuticals, Copenhagen S, Denmark. Electronic address: Kristian.Juul@ferring.com.'}]",European urology focus,['10.1016/j.euf.2018.11.001']
794,30321319,Comparing retainers constructed on conventional stone models and on 3D printed models: a randomized crossover clinical study.,"OBJECTIVES


The aim of this study was to compare vacuum-formed thermoplastic retainers (VFRs) constructed on stone models (VFR-CV) and those constructed on three-dimensional (3D) printed models (VFR-3D) based on patients' perspective and post-treatment stability.
STUDY DESIGN


The research was designed as a crossover, randomized control trial.
MATERIALS AND METHODS


Subjects comprised patients receiving fixed appliances at a teaching institution and indicated for VFRs. Post-treatment stone models were scanned with a structured-light scanner. A fused deposition modelling machine was used to construct acrylonitrile-butadiene-styrene (ABS)-based replicas from the 3D scanned images. VFRs were fabricated on the original stone and printed models. Analysis comprised independent t-tests and repeated measures analysis of variance.
RANDOMIZATION


Subjects were allocated to two groups using Latin squares methods and simple randomization. A week after debond, subjects received either VFR-CV first (group A) or VFR-3D first (group B) for 3 months, then the interventions were crossed over for another 3 months.
BLINDING


In this single-blinded study, subjects were assigned a blinding code for data entry; data were analysed by a third party.
OUTCOME MEASURES


The primary outcome measured was oral health-related quality of life (OHRQoL) based on Oral Health Impact Profile-14 (OHIP-14). Secondary outcome was post-treatment stability measured using Little's Irregularity Index (LII).
RESULTS


A total of 30 subjects (15 in each group) were recruited but 3 dropped out. Analysis included 13 subjects from group A and 14 subjects from group B. Group A showed an increase in LII (P < 0.05) after wearing VFR-CV and VFR-3D, whereas group B had no significant increase in LII after wearing both VFRs. Both groups reported significant improvement in OHRQoL after the first intervention but no significant differences after the second intervention. LII changes and OHIP-14 scores at T2 and T3 between groups, and overall between the retainers were not significantly different. No harm was reported during the study.
CONCLUSION


VFRs made on ABS-based 3D printed models showed no differences in terms of patients' OHRQoL and stability compared with conventionally made retainers.
REGISTRATION


NCT02866617 (ClinicalTrials.gov).",2019,"Conclusion


VFRs made on ABS-based 3D printed models showed no differences in terms of patients' OHRQoL and stability compared with conventionally made retainers.
",['30 subjects (15 in each group) were recruited but 3 dropped out'],"['vacuum-formed thermoplastic retainers (VFRs', 'VFR-CV first (group A) or VFR-3D first']","[""post-treatment stability measured using Little's Irregularity Index (LII"", 'LII changes and OHIP-14 scores', 'oral health-related quality of life (OHRQoL) based on Oral Health Impact Profile-14 (OHIP-14', 'OHRQoL', 'LII']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4551580', 'cui_str': 'Retainer (attribute)'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0029162'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",30.0,0.104057,"Conclusion


VFRs made on ABS-based 3D printed models showed no differences in terms of patients' OHRQoL and stability compared with conventionally made retainers.
","[{'ForeName': 'Norhidayah', 'Initials': 'N', 'LastName': 'Mohd Tahir', 'Affiliation': 'Department of Paediatric Dentistry and Orthodontics, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Wan Nurazreena', 'Initials': 'WN', 'LastName': 'Wan Hassan', 'Affiliation': 'Department of Paediatric Dentistry and Orthodontics, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Roslan', 'Initials': 'R', 'LastName': 'Saub', 'Affiliation': 'Department of Community Oral Health and Clinical Prevention, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia.'}]",European journal of orthodontics,['10.1093/ejo/cjy063']
795,29949271,Two-step shoulder delivery method reduces the incidence of shoulder dystocia.,"OBJECTIVE


io compare two-step method ot shoulder delivery with one-step for the maternal and neonatal outcomes.
MATERIALS AND METHODS


This was a randomized controlled clinical trial. Women scheduled for vaginal delivery without severe complications were enrolled and randomly arranged into two groups. Women in study group were delivered by two-step method for shoulder delivery, that is to wait for at least one contraction after head delivery, and naturally delivery of shoulder. Women in controlled group were delivered by one-step method, that is after the head was delivered, gentle press of head was applied to facility shoulder delivery. Maternal and neonatal outcomes as Apgar score, rate of shoulder dystocia, and postpartum bleeding were recorded. Interval of head to shoulder was timed in second.
RESULTS


The study group had lower rate of shoulder dystocia than that in control group (X²= 4.27,p =0.03), no increasing of asphyxia, and postpartum bleeding. The average interval of head to shoulder in study group was longer than that in control group. There was no difference in interval between shoulder dystocia vs. normal birth group, neither was there a difference in interval between asphyxia babies and normal babies group. By two-step method, the mean value of head to shoulder interval was 59.025 seconds, 95% CI (20.000-150.000 seconds), mean+2xSD = 148.927 seconds. In one-step group, mean was 44.172 seconds, 95% CI= (10.000~105.000 seconds), mean +2xSD = 94.812 seconds.
CONCLUSION


Two-step method of shoulder delivery had a lower rate of shoulder dystocia than one-step method, no increasing of neonatal asphyxia and postpartum bleeding. The longer interval of head to shoulder did not relate to shoulder dystocia and asphyxia. The normal value of head to shoulder interval might be longer than 60 seconds.",2017,"Two-step method of shoulder delivery had a lower rate of shoulder dystocia than one-step method, no increasing of neonatal asphyxia and postpartum bleeding.",['Women scheduled for vaginal delivery without severe complications'],[],"['Maternal and neonatal outcomes as Apgar score, rate of shoulder dystocia, and postpartum bleeding', 'average interval of head to shoulder', 'rate of shoulder dystocia', 'longer interval of head to shoulder', 'incidence of shoulder dystocia', 'mean value of head to shoulder interval', 'neonatal asphyxia and postpartum bleeding', 'asphyxia, and postpartum bleeding']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0269825', 'cui_str': 'Shoulder girdle dystocia (disorder)'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia Neonatorum'}, {'cui': 'C0004044', 'cui_str': 'Suffocation'}]",,0.0716406,"Two-step method of shoulder delivery had a lower rate of shoulder dystocia than one-step method, no increasing of neonatal asphyxia and postpartum bleeding.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
796,29949273,Pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline solution as a distention medium - a prospective randomized study.,"OBJECTIVE


To assess the efficacy of warm normal saline distention solution versus a standard, room-temperature normal saline as distention medium for pain relief during outpatient hysteroscopy.
MATERIALS AND METHODS


A prospective randomized case-placebo controlled study was conducted in tertiary care centre - Central Clinical Hospital of Ministry of Interior and Administration. Study group consisted of 100 women referred for outpatient hysteroscopy between January 2015 and July 2015. Every patient, who was referred for an office hysteroscopy, was offered to participate in the study to receive a sterile, 0.9% normal saline warmed up to 36⁰C as distention medium. Control group were women receiving sterile, room temperature of 25⁰C, 0.9% normal saline solution as a distention medium. No pre-medication nor analgesia were used. A visual analogue scale (VAS) was used for one-dimensional pain assessment. Women were asked to mark a VAS score before, during, and five and 15 minutes following the procedure.
RESULTS


Median VAS scores during and directly after the anaesthesia-free hysteroscopy were no different between two groups. (p = 0.554 and p = 0.121, respectively). There were also no differences in the procedure time between groups (p = 0.845).
CONCLUSIONS


Warm normal saline distention solution does not reduce the pain during and at the end of the outpatient hysteroscopy. The effect does not depend on the age of women, menopausal status, parity or type of outpatient hysteroscopy (operative or diagnostic).",2017,"There were also no differences in the procedure time between groups (p = 0.845).
","['tertiary care centre - Central Clinical Hospital of Ministry of Interior and Administration', '100 women referred for outpatient hysteroscopy between January 2015 and July 2015']","['placebo', 'outpatient hysteroscopy using room temperature versus warm normal saline solution', 'Warm normal saline distention solution', 'warm normal saline distention solution', 'sterile, room temperature of 25⁰C, 0.9% normal saline solution']","['procedure time', 'pain', 'Pain assessment', 'A visual analogue scale (VAS', 'Median VAS scores', 'pain relief']","[{'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",100.0,0.137514,"There were also no differences in the procedure time between groups (p = 0.845).
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Issat', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Beta', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Nowicka', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Durczynski', 'Affiliation': ''}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Jakimiuk', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
797,30440816,Impact of nurse-assisted patient turning at different sleep stages on the quality of subsequent sleep .,"BACKGROUND


Nursing care performed during sleep, including nurse-assisted patient turning, is one of the factors that deteriorates sleep quality but is necessary for pressure ulcer prevention. Thus, it is important to determine when nurseassisted patient turning has the least impact on sleep quality.
AIM


The aim of this study was to clarify the impact of nurseassisted patient turning at different sleep stages and to determine the optimal timing of this aspect during sleep.
METHODS


The experiment, which consisted of healthy men in their 20s and 30s, was performed over four successive nights per subject. The first night was dedicated to environment adaptation, and the 2nd to the 4th nights were randomly assigned for shallow sleep intervention, deep sleep intervention, and non-intervention. On the intervention day, nurse-assisted patient turning was conducted twice. Overnight sleep conditions were measured by polysomnography (PSG). The PSG waveform transmitted to a tablet was analyzed in real time to determine the stage of sleep. The patient was turned when he entered the planned stage of sleep.
RESULTS


The study analyzed fourteen (14) subjects. Shallow sleep time, deep sleep time, and sleep resumption time after nurse-assisted patient turning were compared among the three groups of non-intervention day, shallow sleep intervention day and deep sleep intervention day. There was no significant difference in the shallow and deep sleep time among the three groups. However, sleep resumption time after nurse-assisted patient turning was significantly shorter on the deep sleep intervention day than on the shallow sleep intervention day (p = textbf 0.033).
CONCLUSIONS


This study has novelty in examining the impact of nurse-assisted patient turning performed at different sleep stages on subsequent sleep using objective indicators. The study suggested that a deep sleep state is the optimal timing of nurseassisted patient turning due to the short time to sleep resumption.",2018,There was no significant difference in the shallow and deep sleep time among the three groups.,['fourteen (14) subjects'],"['nurse-assisted patient turning at different sleep stages', 'shallow sleep intervention, deep sleep intervention, and non-intervention']","['Overnight sleep conditions', 'shallow and deep sleep time', 'quality of subsequent sleep ', 'Shallow sleep time, deep sleep time, and sleep resumption time', 'sleep resumption time']","[{'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",14.0,0.0166196,There was no significant difference in the shallow and deep sleep time among the three groups.,"[{'ForeName': 'Hisayoshi', 'Initials': 'H', 'LastName': 'Sugawara', 'Affiliation': ''}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Amemiya', 'Affiliation': ''}, {'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Kase', 'Affiliation': ''}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Masujima', 'Affiliation': ''}, {'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Sakai', 'Affiliation': ''}, {'ForeName': 'Yuji L', 'Initials': 'YL', 'LastName': 'Tanaka', 'Affiliation': ''}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Komiyama', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2018.8512679']
798,31558739,"Rice bran supplementation modulates growth, microbiota and metabolome in weaning infants: a clinical trial in Nicaragua and Mali.","Rice bran supplementation provides nutrients, prebiotics and phytochemicals that enhance gut immunity, reduce enteric pathogens and diarrhea, and warrants attention for improvement of environmental enteric dysfunction (EED) in children. EED is a subclinical condition associated with stunting due to impaired nutrient absorption. This study investigated the effects of rice bran supplementation on weight for age and length for age z-scores (WAZ, LAZ), EED stool biomarkers, as well as microbiota and metabolome signatures in weaning infants from 6 to 12 months old that reside in Nicaragua and Mali. Healthy infants were randomized to a control (no intervention) or a rice bran group that received daily supplementation with increasing doses at each month (1-5 g/day). Stool microbiota were characterized using 16S rDNA amplicon sequencing. Stool metabolomes were analyzed using ultra-high-performance liquid-chromatography tandem mass-spectrometry. Statistical comparisons were completed at 6, 8, and 12 months of age. Daily consumption of rice bran was safe and feasible to support changes in LAZ from 6-8 and 8-12 months of age in Nicaragua and Mali infants when compared to control. WAZ was significantly improved only for Mali infants at 8 and 12 months. Mali and Nicaraguan infants showed major differences in the overall gut microbiota and metabolome composition and structure at baseline, and thus each country cohort demonstrated distinct microbial and metabolite profile responses to rice bran supplementation when compared to control. Rice bran is a practical dietary intervention strategy that merits development in rice-growing regions that have a high prevalence of growth stunting due to malnutrition and diarrheal diseases. Rice is grown as a staple food, and the bran is used as animal feed or wasted in many low- and middle-income countries where EED and stunting is prevalent.",2019,Daily consumption of rice bran was safe and feasible to support changes in LAZ from 6-8 and 8-12 months of age in Nicaragua and Mali infants when compared to control.,"['weaning infants', 'children', 'Healthy infants', 'weaning infants from 6 to 12 months old that reside in Nicaragua and Mali']","['Rice bran supplementation', 'control (no intervention) or a rice bran group that received daily supplementation', 'Rice bran', 'rice bran', 'rice bran supplementation']","['overall gut microbiota and metabolome composition and structure', 'growth, microbiota and metabolome', 'weight for age and length for age z-scores (WAZ, LAZ), EED stool biomarkers', 'Stool metabolomes', 'WAZ', 'safe and feasible to support changes in LAZ']","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028002', 'cui_str': 'Nicaragua'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}]","[{'cui': 'C3810876', 'cui_str': 'Rice bran'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0249178,Daily consumption of rice bran was safe and feasible to support changes in LAZ from 6-8 and 8-12 months of age in Nicaragua and Mali infants when compared to control.,"[{'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Zambrana', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Starin', 'Initials': 'S', 'LastName': 'McKeen', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Hend', 'Initials': 'H', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Zarei', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Erica C', 'Initials': 'EC', 'LastName': 'Borresen', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Lassina', 'Initials': 'L', 'LastName': 'Doumbia', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Boré', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Alima', 'Initials': 'A', 'LastName': 'Cissoko', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Seydou', 'Initials': 'S', 'LastName': 'Douyon', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Koné', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Center of Infectious Diseases, Department of Microbiology and Parasitology, Faculty of Medical Sciences, National Autonomous University of Nicaragua, León (UNAN-León), León, Nicaragua.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Perez', 'Affiliation': 'Center of Infectious Diseases, Department of Microbiology and Parasitology, Faculty of Medical Sciences, National Autonomous University of Nicaragua, León (UNAN-León), León, Nicaragua.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hess', 'Affiliation': 'Department of Statistics, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Abdo', 'Affiliation': 'Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO, 80521, USA.'}, {'ForeName': 'Lansana', 'Initials': 'L', 'LastName': 'Sangaré', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Ababacar', 'Initials': 'A', 'LastName': 'Maiga', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Becker-Dreps', 'Affiliation': 'Departments of Family Medicine and Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599-7595, USA.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Biomedical Sciences and Pathobiology, Virginia-Maryland College of Veterinary Medicine, Virginia Polytechnic Institute and State University, Blacksburg, VA, 24061, USA.'}, {'ForeName': 'Ousmane', 'Initials': 'O', 'LastName': 'Koita', 'Affiliation': 'Laboratoire de Biologie Moléculaire Appliquée, Campus de Badalabougou, Université des Sciences, des Techniques et des Technologies de Bamako, BP: 1805, Bamako, Mali. okoita@icermali.org.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Vilchez', 'Affiliation': 'Center of Infectious Diseases, Department of Microbiology and Parasitology, Faculty of Medical Sciences, National Autonomous University of Nicaragua, León (UNAN-León), León, Nicaragua. samuelvilchez@gmail.com.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Ryan', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, 80523, USA. E.P.Ryan@colostate.edu.'}]",Scientific reports,['10.1038/s41598-019-50344-4']
799,29893222,"Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study.","BACKGROUND


Guselkumab, a human monoclonal antibody that binds to the p19 subunit of interleukin 23, has been approved for the treatment of moderate-to-severe psoriasis. Psoriatic arthritis is a common comorbidity of psoriasis with an umet need for novel treatments. We assessed the efficacy and safety of guselkumab in patients with active psoriatic arthritis.
METHODS


We did a randomised, double-blind, placebo-controlled, phase 2a trial at 34 rheumatology and dermatology practices in Canada, Germany, Poland, Romania, Russia, Spain, and the USA. Eligible participants were aged 18 years or older with active psoriatic arthritis and plaque psoriasis affecting at least 3% of their body surface area, with three or more of 66 tender joints and three or more of 68 swollen joints, who had an inadequate response or intolerance to standard treatments. We randomly assigned patients (2:1) via a central interactive web-response system using computer-generated permuted blocks with a block size of six, stratified by previous anti-tumour necrosis factor-α use, to receive subcutaneous guselkumab 100 mg or placebo at week 0, week 4, and every 8 weeks thereafter for 24 weeks. Patients, investigators, and site staff were masked to treatment assignment until final database lock at week 56. At week 16, patients with less than 5% improvement in swollen and tender joint counts were eligible for early escape to ustekinumab. At week 24, the remaining placebo-treated patients crossed over to receive guselkumab 100 mg at weeks 24, 28, 36, and 44 and guselkumab-treated patients received a placebo injection at week 24, followed by guselkumab injections at weeks 28, 36, and 44. The primary endpoint was the proportion of patients with at least 20% improvement at week 24 in signs and symptoms of psoriatic arthritis according to American College of Rheumatology criteria (ACR20) in the modified intention-to-treat population (ie, all randomly assigned patients who received at least one dose of study treatment). Safety analyses included patients according to the study drug received. This study is registered with ClinicalTrials.gov, number NCT02319759.
FINDINGS


Between March 27, 2015, and Jan 17, 2017, we randomly assigned 149 patients to treatment: 100 to guselkumab and 49 to placebo. 17 (35%) of 49 patients in the placebo group and ten (10%) of 100 patients in the guselkumab group were eligible for early escape to ustekinumab at week 16. 29 (59%) of 49 patients in the placebo group crossed over and received guselkumab at week 24. Three (6%) of 49 patients in the placebo group, one (3%) of 29 patients who crossed over from placebo to guselkumab, and six (6%) of 100 patients in the guselkumab group discontinued study treatment before week 44. 58 (58%) of 100 patients in the guselkumab group and nine (18%) of 49 patients in the placebo group achieved an ACR20 response at week 24 (percentage difference 39·7% [95% CI 25·3-54·1]; p<0·0001). Between week 0 and week 24, 36 (36%) of 100 guselkumab-treated patients and 16 (33%) of 49 placebo-treated patients had at least one adverse event. The most frequent adverse event was infection in both groups (16 [16%] of 100 patients in the guselkumab group vs ten [20%] of 49 patients in the placebo group). The prevalence of adverse events between week 0 and week 56 in guselkumab-treated patients (51 [40%] of 129) indicated no disproportional increase with longer guselkumab exposure. No deaths occurred.
INTERPRETATION


Guselkumab, a novel anti-interleukin 23p19 antibody, significantly improved signs and symptoms of active psoriatic arthritis and was well tolerated during 44 weeks of treatment. The results of this study support further development of guselkumab as a novel and comprehensive treatment in psoriatic arthritis.
FUNDING


Janssen Research & Development.",2018,The most frequent adverse event was infection in both groups (16 [16%] of 100 patients in the guselkumab group vs ten [20%] of 49 patients in the placebo group).,"['34 rheumatology and dermatology practices in Canada, Germany, Poland, Romania, Russia, Spain, and the USA', 'Between March 27, 2015, and Jan 17, 2017, we randomly assigned 149 patients to treatment: 100 to guselkumab and 49 to', 'patients with active psoriatic arthritis', 'Eligible participants were aged 18 years or older with active psoriatic arthritis and plaque psoriasis affecting at least 3% of their body surface area, with three or more of 66 tender joints and three or more of 68 swollen joints, who had an inadequate response or intolerance to standard treatments', '58']","['guselkumab', 'placebo-treated patients crossed over to receive guselkumab', 'placebo', 'placebo injection', 'central interactive web-response system using computer-generated permuted blocks with a block size of six, stratified by previous anti-tumour necrosis factor-α use, to receive subcutaneous guselkumab 100 mg or placebo']","['prevalence of adverse events', 'swollen and tender joint counts', 'Efficacy and safety', 'proportion of patients with at least 20% improvement at week 24 in signs and symptoms of psoriatic arthritis', 'efficacy and safety', 'ACR20 response']","[{'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}]",149.0,0.553257,The most frequent adverse event was infection in both groups (16 [16%] of 100 patients in the guselkumab group vs ten [20%] of 49 patients in the placebo group).,"[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, USA. Electronic address: deodhara@ohsu.edu.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, New York Medical College at Metropolitan Hospital, New York, NY, USA.'}, {'ForeName': 'Wolf-Henning', 'Initials': 'WH', 'LastName': 'Boehncke', 'Affiliation': 'Division of Dermatology and Venereology, Geneva University Hospital, Geneva, Switzerland; Department of Pathology and Immunology, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': 'Clinical Biostatistics, Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'Yuhua', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Clinical Biostatistics, Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': 'Clinical Pharmacology, Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Barchuk', 'Affiliation': 'Immunology Clinical Development, Eli Lilly and Company, San Diego, CA, USA.'}, {'ForeName': 'Xie L', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Immunology, Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Immunology, Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)30952-8']
800,31642088,A nurse-led lifestyle intervention using mobile application versus booklet for adults with metabolic syndrome-Protocol for a randomized controlled trial.,"AIMS


To compare the effect of a lifestyle intervention programme using mobile application versus booklet for adults with metabolic syndrome (MetS) living in the community.
DESIGN


A multisite randomized controlled trial with three parallel arms, namely metabolic syndrome app group, booklet group, and control group.
METHODS


The research study has been supported by the Health and Medical Research fund in Hong Kong in 2019. The protocol was approved by the study university and the selected community centres. Three hundred and sixty subjects will be recruited from community centres and randomized into either one arm. Inclusion criteria are those adult with MetS, able to use a smart phone. All participants received a 30-min health educational session. App group participants will receive a mobile application while booklet group participants will receive a specific booklet of MetS care and the control group receive a placebo booklet only. The primary outcomes comprises of body weight. The secondary outcomes include total physical exercise, cardiometablolic risk factors, cardiovascular endurance, self-efficacy for exercise, and stress level. Data will be collected at baseline, weeks 4, 12, and 24. SPSS and generalized estimating equations model will be employed for data analysis.
DISCUSSION


Metabolic syndrome is a common health problem associated with the heightened risk of cardiovascular disease and the risks are potentially amenable to lifestyle intervention. The results will compare the relative effectiveness of a lifestyle intervention using an app versus a booklet on physical and psychological outcomes for adults with MetS.
IMPACT


What problem will the study address? The results will inform the healthcare professional and nurses about the effective way for health promotion, to enhance patient's lifestyle modification and exercise sustainability that will be beneficial to the clients' health.",2020,"The secondary outcomes include total physical exercise, cardiometablolic risk factors, cardiovascular endurance, self-efficacy for exercise and stress level.","['adults with metabolic syndrome', 'adults with metabolic syndrome living in the community', 'Three hundred and sixty subjects will be recruited from community centers and randomized into either one arm']","['mobile application while Booklet Group participants will receive a specific booklet of metabolic syndrome care and the control group receive a placebo booklet only', 'lifestyle intervention programme using mobile application versus booklet', '30-min health educational session', 'booklet group and control group', 'life- style intervention']","['total physical exercise, cardiometablolic risk factors, cardiovascular endurance, self-efficacy for exercise and stress level', 'body weight']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",360.0,0.102776,"The secondary outcomes include total physical exercise, cardiometablolic risk factors, cardiovascular endurance, self-efficacy for exercise and stress level.","[{'ForeName': 'Eliza Mi-Ling', 'Initials': 'EM', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, SAR, China.'}, {'ForeName': 'Doris Y P', 'Initials': 'DYP', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, SAR, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Angela Y M', 'Initials': 'AYM', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, SAR, China.'}]",Journal of advanced nursing,['10.1111/jan.14241']
801,31542737,Decision support intervention (Plan Well Guide) for patients and their substitute decision-makers to improve engagement in advance care planning: protocol for a randomised trial.,"OBJECTIVE


The purpose of this randomised trial is to evaluate the efficacy of a decision support intervention for serious illness decisions (the Plan Well Guide decision aid; www.PlanWellguide.com) in increasing the engagement of substitute decision-makers (SDMs) in the patient's advance care planning process (ie, 'ACP engagement'), specifically the SDM's confidence and readiness for the role in the future.
METHODS AND ANALYSIS


This study is a parallel group randomised controlled trial. We aim to enrol 90 participant dyads: patients aged 65 years and older attending outpatient healthcare settings and with indicators they would be at high risk of needing future medical decisions and their SDM. The intervention is the Plan Well Guide decision aid, administered to the patient by a facilitator, with the SDM present. The primary endpoint is change after 3 months in the SDM's ACP engagement using a validated measure of behavioural change (SDM's knowledge, contemplation, self-efficacy and readiness) to enact the role. The secondary endpoints are (1) ACP engagement of the patient measured by a validated survey; (2) change in SDM decisional conflict regarding involvement in future decision-making and (3) postintervention patient decisional conflict regarding preference for life-sustaining treatments. Primary and secondary continuous outcomes will be analysed using the linear regression. The mean difference and 95% CIs will be reported.
ETHICS AND DISSEMINATION


Approval was received August 2017 (2017-3714-GRA) from the Hamilton Integrated Research Ethics Board. We plan to disseminate trial results in peer-reviewed journals, at national and international conferences, and via our web-based knowledge translation platforms.
TRIAL REGISTRATION NUMBER


NCT03239639; Pre-results.",2019,"The primary endpoint is change after 3 months in the SDM's ACP engagement using a validated measure of behavioural change (SDM's knowledge, contemplation, self-efficacy and readiness) to enact the role.","['enrol 90 participant dyads: patients aged 65 years and older attending outpatient healthcare settings and with indicators they would be at high risk of needing future medical decisions and their SDM', 'Approval was received August 2017 (2017-3714-GRA) from the Hamilton Integrated Research Ethics Board']","['decision support intervention', 'Decision support intervention (Plan Well Guide']","[""behavioural change (SDM's knowledge, contemplation, self-efficacy and readiness) to enact the role"", 'ACP engagement of the patient measured by a validated survey; (2) change in SDM decisional conflict regarding involvement in future decision-making and (3) postintervention patient decisional conflict regarding preference for life-sustaining treatments']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0730261', 'cui_str': 'Attends outpatients'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0035168'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",90.0,0.165627,"The primary endpoint is change after 3 months in the SDM's ACP engagement using a validated measure of behavioural change (SDM's knowledge, contemplation, self-efficacy and readiness) to enact the role.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Howard', 'Affiliation': 'Family Medicine, McMaster University, Hamilton, Ontario, Canada mhoward@mcmaster.ca.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Slaven', 'Affiliation': 'Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Bernard', 'Affiliation': 'Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sayem', 'Initials': 'S', 'LastName': 'Borhan', 'Affiliation': 'Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Elston', 'Affiliation': 'Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Arora', 'Affiliation': 'Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'Department of Family Medicine, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada.'}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Critical Care, Queen's University, Kingston, Ontario, Canada.""}]",BMJ open,['10.1136/bmjopen-2018-027897']
802,29872682,"Cryotherapy plus oral zinc sulfate versus cryotherapy plus placebo to treat common warts: A double blind, randomized, placebo-controlled trial.","Background


Cutaneous warts are caused by a small group of specific types of human papillomaviruses. Cryotherapy is a highly effective treatment for patients with viral warts; however, it is a painful method and usually requires several treatment sessions. Zinc is a trace element with many proven effects on the immune system.
Objective


Our aim was to assess the efficacy and safety of oral zinc sulfate in the treatment and recurrence rate of common warts.
Methods


Eighty-three patients with common warts participated in this double-blind, randomized, placebo-controlled trial. In both groups, three sessions of liquid nitrogen cryotherapy were performed for up to 2 months with 3-week intervals. The treatment group (n = 45) received oral zinc sulfate capsules in a dose of 10 mg/kg per day up to 600 mg day. The control group (n = 38) was provided with placebo of similar appearance. Treatment continued for 2 months and the follow-up period lasted up to 6 months.
Results


Warts completely resolved in 26 patients in the treatment group (68.4%) and 23 patients in the placebo group (63.9%;  p  = .68). Three patients (7.9%) in the treatment group and six patients (16.6%) in the placebo group has a recurrence of the warts ( p  = .19).
Conclusion


According to our study, the addition of zinc to cryotherapy was not beneficial in the treatment of patients with common warts nor did it prevent recurrences.",2018,"Results


Warts completely resolved in 26 patients in the treatment group (68.4%) and 23 patients in the placebo group (63.9%;  p  = .68).","['patients with viral warts', 'Methods\n\n\nEighty-three patients with common warts', 'treat common warts']","['oral zinc sulfate capsules', 'liquid nitrogen cryotherapy', 'Cryotherapy', 'placebo', 'placebo of similar appearance', 'oral zinc sulfate', 'Cryotherapy plus oral zinc sulfate versus cryotherapy plus placebo']",['efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043037', 'cui_str': 'Verruca vulgaris (disorder)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0260055', 'cui_str': 'Liquid nitrogen (substance)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",83.0,0.403036,"Results


Warts completely resolved in 26 patients in the treatment group (68.4%) and 23 patients in the placebo group (63.9%;  p  = .68).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S Z', 'Initials': 'SZ', 'LastName': 'Ghodsi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tavakolpour', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Daneshpazhooh', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of women's dermatology,['10.1016/j.ijwd.2017.09.004']
803,31639195,Postoperative Venous Thromboembolism Prophylaxis Utilizing Enoxaparin Does Not Increase Bleeding Complications After Abdominal Body Contouring Surgery.,"BACKGROUND


Venous thromboembolism (VTE) chemoprophylaxis warrants an individualized, risk-stratified approach, and constitutes a relatively controversial topic in plastic surgery.
OBJECTIVES


The aim of this study was to determine the safety of a 7-day postoperative enoxaparin regimen for VTE prophylaxis compared with a single preoperative dose of heparin in abdominal body contouring surgery.
METHODS


This single-institution pre-post study investigated the safety of a 7-day enoxaparin postoperative regimen in abdominal body contouring procedures performed by a single surgeon from 2007 to 2018. Four procedures were included: traditional panniculectomy, abdominoplasty, fleur-de-lis panniculectomy, and body contouring liposuction. Group I patients received a single dose of 5000 U subcutaneous heparin in the preoperative period, and no postoperative chemical prophylaxis was administered. Group II patients received 40 mg subcutaneous enoxaparin in the immediate preoperative period, then once daily for 7 days postoperatively.
RESULTS


A total of 195 patients were included in the study, 66 in Group I and 129 in Group II. The groups demonstrated statistically similar VTE risk profiles, based on the 2005 Caprini risk-assessment model. There were no statistically significant differences in the 2 primary outcomes: postoperative bleeding and VTE events. Group I patients had higher reoperation rates (22.7% vs 10.1%, P = 0.029), which was secondary to higher rates of revision procedures.
CONCLUSIONS


A 7-day postoperative course of once-daily enoxaparin for VTE risk reduction in abdominal body contouring surgery does not significantly increase the risk of bleeding. Implementation of this regimen for postdischarge chemoprophylaxis, when indicated following individualized risk stratification, is appropriate.
LEVEL OF EVIDENCE: 4


",2020,"Group I patients had higher reoperation rates (22.7 percent versus 10.1 percent, p = 0.029), which was secondary to higher rates of revision procedures.
","['abdominal body contouring procedures performed by a single surgeon from 2007 to 2018', 'A total of 195 patients were included in the study, 66 in Group I and 129 in Group II', 'Four procedures were included: traditional panniculectomy, abdominoplasty, fleur-de-lis panniculectomy, and body contouring liposuction']","['heparin', 'Enoxaparin', 'enoxaparin', '40 mg subcutaneous enoxaparin']","['reoperation rates', 'risk of bleeding', 'postoperative bleeding and VTE events', 'VTE risk profiles', 'Bleeding Complications']","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C2713286', 'cui_str': 'Panniculectomy'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C0038640', 'cui_str': 'Aspiration Lipectomy'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",195.0,0.111892,"Group I patients had higher reoperation rates (22.7 percent versus 10.1 percent, p = 0.029), which was secondary to higher rates of revision procedures.
","[{'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Vasilakis', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Gabriel M', 'Initials': 'GM', 'LastName': 'Klein', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trostler', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Muntazim', 'Initials': 'M', 'LastName': 'Mukit', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Jocellie E', 'Initials': 'JE', 'LastName': 'Marquez', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Dagum', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Pannucci', 'Affiliation': 'Division of Plastic Surgery, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Sami U', 'Initials': 'SU', 'LastName': 'Khan', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}]",Aesthetic surgery journal,['10.1093/asj/sjz274']
804,29773516,Lymphoedema management to prevent acute dermatolymphangioadenitis in podoconiosis in northern Ethiopia (GoLBeT): a pragmatic randomised controlled trial.,"BACKGROUND


Podoconiosis (also known as endemic, non-filarial elephantiasis) affects about 4 million subsistence farmers in tropical Africa. Poor awareness of the condition and inadequate evidence for the efficacy of treatment mean that no government in an endemic country yet offers lymphoedema management for patients with podoconiosis. Among patients with filarial lymphoedema, trials suggest that limb care is effective in reducing the most disabling sequelae: episodes of acute dermatolymphangioadenitis. We aimed to test the hypothesis that a simple, inexpensive lymphoedema management package would reduce the incidence of acute dermatolymphangioadenitis in adult patients with podoconiosis in northern Ethiopia.
METHODS


We did a pragmatic randomised controlled trial at health posts and health centres in 18 sub-districts of Aneded woreda (district) in Amhara, northern Ethiopia. Participants were adults aged 18 years and older, had a diagnosis of at least stage 2 podoconiosis (persistent lymphoedema) and a negative antigen test for filariasis, and intended to remain within Aneded woreda for the duration of the trial. Patients were randomly assigned (1:1) to either receive a package containing instructions for foot hygiene, skin care, bandaging, exercises, and use of socks and shoes, with support by lay Community Podoconiosis Agents at monthly meetings (intervention group) or to receive no intervention (control group). Participants were aware of their group assignment, but researchers doing all analyses were masked to treatment group. The primary outcome was incidence of acute dermatolymphangioadenitis episodes in the total period of observation of each participant, measured by use of validated patient self-reported pictorial diaries. This trial was registered with the International Standard Randomised Controlled Trials Number Register, number ISRCTN67805210.
FINDINGS


Between Dec 1, 2014, and June 30, 2015, 1339 patients were screened, and 696 patients were enrolled and randomly allocated to treatment groups. We allocated 350 patients to the intervention group and 346 patients to the control group. 321 (92%) patients from the intervention group and 329 (95%) patients from the control group provided follow-up results at 12 months. During the 12 months of follow-up, 16 550 new episodes of acute dermatolymphangioadenitis occurred during 765·2 person-years. The incidence of acute dermatolymphangioadenitis was 19·4 episodes per person-year (95% CI 18·9-19·9) in the intervention group and 23·9 episodes per person-year (23·4-24·4) in the control group. The ratio of incidence rate in the intervention group to that of the control group was 0·81 (0·74 to 0·89; p<0·0001), with a rate difference of -4·5 (-5·1 to -3·8) episodes per person-year. No serious adverse events related to the intervention were reported.
INTERPRETATION


A simple, inexpensive package of lymphoedema self-care is effective in reducing the frequency and duration of acute dermatolymphangioadenitis. We recommend its implementation by the governments of endemic countries.
FUNDING


Joint Global Health Trials scheme (from the Wellcome Trust, the UK Medical Research Council, and UK Aid).",2018,The ratio of incidence rate in the intervention group to that of the control group was 0·81,"['Between Dec 1, 2014, and June 30, 2015', 'Participants were adults aged 18 years and older, had a diagnosis of at least stage 2 podoconiosis (persistent lymphoedema) and a negative antigen test for filariasis, and intended to remain within Aneded woreda for the duration of the trial', 'adult patients with podoconiosis in northern Ethiopia', 'patients with filarial lymphoedema', 'acute dermatolymphangioadenitis in podoconiosis in northern Ethiopia (GoLBeT', '350 patients to the intervention group and 346 patients to the control group', 'patients with podoconiosis', '1339 patients were screened, and 696 patients', 'health posts and health centres in 18 sub-districts of Aneded woreda (district) in Amhara, northern Ethiopia']","['package containing instructions for foot hygiene, skin care, bandaging, exercises, and use of socks and shoes, with support by lay Community Podoconiosis Agents at monthly meetings (intervention group) or to receive no intervention (control group']","['incidence of acute dermatolymphangioadenitis episodes in the total period of observation of each participant, measured by use of validated patient self-reported pictorial diaries', 'acute dermatolymphangioadenitis', 'ratio of incidence rate', 'rate difference of -4·5 (-5·1 to -3·8) episodes per person-year', 'incidence of acute dermatolymphangioadenitis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1280469', 'cui_str': 'Lymphostatic Verrucosis'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0729856', 'cui_str': 'Antigen test (procedure)'}, {'cui': 'C0016085', 'cui_str': 'Filarioidea Infections'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}]","[{'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0445269', 'cui_str': 'Socks (physical object)'}, {'cui': 'C0185506', 'cui_str': 'Shoeing'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1280469', 'cui_str': 'Lymphostatic Verrucosis'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1339.0,0.193259,The ratio of incidence rate in the intervention group to that of the control group was 0·81,"[{'ForeName': 'Henok', 'Initials': 'H', 'LastName': 'Negussie', 'Affiliation': 'Wellcome Trust Centre for Global Health Research, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Meseret', 'Initials': 'M', 'LastName': 'Molla', 'Affiliation': 'Centre for Environmental and Developmental Studies, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Ngari', 'Affiliation': 'KEMRI Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Berkley', 'Affiliation': 'KEMRI Wellcome Trust Research Programme, Kilifi, Kenya; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kivaya', 'Affiliation': 'KEMRI Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Njuguna', 'Affiliation': 'KEMRI Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Fegan', 'Affiliation': 'KEMRI Wellcome Trust Research Programme, Kilifi, Kenya; Swansea University Medical School, Swansea, UK.'}, {'ForeName': 'Abreham', 'Initials': 'A', 'LastName': 'Tamiru', 'Affiliation': 'International Orthodox Christian Charities, Debre Markos, Ethiopia.'}, {'ForeName': 'Abebe', 'Initials': 'A', 'LastName': 'Kelemework', 'Affiliation': 'International Orthodox Christian Charities, Debre Markos, Ethiopia.'}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Lang', 'Affiliation': 'KEMRI Wellcome Trust Research Programme, Kilifi, Kenya; Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Newport', 'Affiliation': 'Wellcome Trust Centre for Global Health Research, Brighton and Sussex Medical School, Brighton, UK.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'McKay', 'Affiliation': 'Department of Economics, University of Sussex, Brighton, UK.'}, {'ForeName': 'Fikre', 'Initials': 'F', 'LastName': 'Enquoselassie', 'Affiliation': 'School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Davey', 'Affiliation': 'Wellcome Trust Centre for Global Health Research, Brighton and Sussex Medical School, Brighton, UK; School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia. Electronic address: g.davey@bsms.ac.uk.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30124-4']
805,29734556,Cervical cytology ASCUS patients with HPV detection and clinical value.,"OBJECTIVE


Patients whose cervical cytological exams produced a result of atypical squamous cells of undetermined significance (ASCUS) were asked to undergo human papillomavirus (HPV DNA) genotyping detection to assess the role of HPV infection in ASCUS.
MATERIALS AND METHODS


This study included 1,219 patients with ASCUS that were randomly divided into two groups. The first group contained 618 patients. These participants underwent colposcopy with cervical biopsy. The remaining 601 underwent colposcopy and biopsy with HPV DNA detection.
RESULTS


Out of the 56,000 patients with ASCUS who underwent ThinPrep cytology test (TCT) de- tection in the authors' hospitals' gynecological outpatient clinics, 1,604 were diagnosed with ASCUS (2.86%). Among the 1,219 patients with ASCUS, the rate of detection of cervical intraepithelial neoplasia (CIN) and cancerization was 22.89% (279/1,219). Among the 601 patients who underwent HPV testing, 182 were positive for high-risk HPV (30.28%). Among HPV-positive samples, the most common high-risk types were HPV16, and HPV58. The most common low-risk types were HPV6 and HPV 11. The rate of detection among high- risk patients who were positive for HPV and cervical carcinoma with intraepithelial neoplasia was 70.88% (129/182). The rate of detection for HPV-negative patients with cervical cancer with intraepithelial neoplasia was 11.55% (47/407). The rate of detection of high-risk HPV was higher than among patients who had not undergone HPV detection and among patients who were negative for HPV (p < 0.05).
CONCLUSION


The results of cervical cytological examination showed that the manner of progression from inflammation to cancer could differ considerably. HPV DNA examination is an effective means of categorizing and managing ASCUS.",2016,"The rate of detection of high-risk HPV was higher than among patients who had not undergone HPV detection and among patients who were negative for HPV (p < 0.05).
","['1,219 patients with ASCUS', '56,000 patients with ASCUS who underwent', '601 patients who underwent HPV testing, 182 were positive for high-risk HPV (30.28', 'Cervical cytology ASCUS patients with HPV detection and clinical value', 'high- risk patients who were positive for HPV and cervical carcinoma with intraepithelial neoplasia was 70.88% (129/182', ""tection in the authors' hospitals' gynecological outpatient clinics, 1,604 were diagnosed with ASCUS (2.86""]","['ThinPrep cytology test (TCT', 'colposcopy with cervical biopsy', 'de']","['rate of detection of cervical intraepithelial neoplasia (CIN) and cancerization', 'rate of detection', 'rate of detection of high-risk HPV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521184', 'cui_str': 'ASCUS'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0856201', 'cui_str': 'Cervical cytology'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix (disorder)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C4517640', 'cui_str': '2.86 (qualifier value)'}]","[{'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0677634', 'cui_str': 'Reptilase Time'}, {'cui': 'C0009417', 'cui_str': 'Colposcopy'}, {'cui': 'C0195314', 'cui_str': 'Cervical biopsy (procedure)'}]","[{'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]",1219.0,0.0511441,"The rate of detection of high-risk HPV was higher than among patients who had not undergone HPV detection and among patients who were negative for HPV (p < 0.05).
","[{'ForeName': 'J X', 'Initials': 'JX', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Yao', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Xiang', 'Affiliation': ''}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Zhan', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Mei', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
806,29746027,Assessment of β-hydroxydeoxyguanosine levels in patients with preeclampsia: a prospective study.,"PURPOSE OF INVESTIGATION


To determine the levels of 8-hydroxydeoxyguanosine (8-OHdG) in preeclampsia (PE) using (enzyme-linked immunosorbent assay (ELISA) method.
MATERIALS AND METHODS


Twenty-two pregnant women with severe PE, 18 pregnant women with mild PE, and 40 healthy pregnant women, all between 25 and 41 weeks of gestation, were enrolled in this prospective controlled study. 8-OHdG levels in maternal serum were measured using ELISA method.
RESULTS


The authors observed no statistically significant difference in 8-OHdG levels between the mild-severe PE and control groups (p = 0.208).
CONCLUSION


The present results do not support the concept that 8-OHdG has a role in the etiopathogenesis of PE.",2017,"To determine the levels of 8-hydroxydeoxyguanosine (8-OHdG) in preeclampsia (PE) using (enzyme-linked immunosorbent assay (ELISA) method.
","['patients with preeclampsia', 'Twenty-two pregnant women with severe PE, 18 pregnant women with mild PE, and 40 healthy pregnant women, all between 25 and 41 weeks of gestation']",[],"['8-OHdG levels', '8-OHdG levels in maternal serum', 'levels of 8-hydroxydeoxyguanosine (8-OHdG) in preeclampsia (PE', 'β-hydroxydeoxyguanosine levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0050078', 'cui_str': ""2'-deoxy-8-oxo-7,8-dihydroguanosine""}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}]",22.0,0.0788414,"To determine the levels of 8-hydroxydeoxyguanosine (8-OHdG) in preeclampsia (PE) using (enzyme-linked immunosorbent assay (ELISA) method.
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Akinci', 'Affiliation': ''}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Özcan', 'Affiliation': ''}, {'ForeName': 'Ö', 'Initials': 'Ö', 'LastName': 'Balat', 'Affiliation': ''}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Uğur', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Öztürk', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Taysi', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sucu', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
807,29734547,The comparison of EMG-biofeedback and extracorporeal magnetic innervation treatments in women with urinary incontinence.,"PURPOSE


This study aimed to compare the effectiveness of EMG-biofeedback (EMG-BF), extracorporeal magnetic innervation (ExMI), and pelvic floor muscle training (PFMT) treatments on women with stress urinary incontinence (SUI). Materials and Meth- ods: The study included 67 women with SUI. Pelvic floor muscles (PFMs) were evaluated with electromyography and the quality of life (QoL) with Incontinence Quality of Life (I-QoL) questionnaire; afterwards, the subjects were divided into three groups; EMG-BF group (n=23), ExMI group (n=20), and PFMT group (n=24). EMG-BF group and ExMI group were given training in urogynecologi- cal physiotherapy clinic. PFMT group were given eight-week home exercises. Each group was assessed before training and after eight weeks.
RESULTS


All three groups showed a significant improvement in EMG activity values and average QoL scores. The greatest im- provement was observed in the EMG-BF training group for QoL scores.
CONCLUSIONS


This study demonstrated that all of the three methods performed with the purpose of increasing PFM strength were effective. The increase in PFM strength reduces incontinence associated symptoms and thus improves Qol.",2016,All three groups showed a significant improvement in EMG activity values and average QoL scores.,"['women with stress urinary incontinence (SUI', 'women with urinary incontinence', '67 women with SUI']","['EMG-biofeedback and extracorporeal magnetic innervation treatments', 'urogynecologi- cal physiotherapy clinic', 'EMG-BF training', 'EMG-biofeedback (EMG-BF), extracorporeal magnetic innervation (ExMI), and pelvic floor muscle training (PFMT', 'PFMT']","['EMG activity values and average QoL scores', 'quality of life (QoL) with Incontinence Quality of Life (I-QoL) questionnaire', 'greatest im- provement']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1619351', 'cui_str': 'nerve supply'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",67.0,0.0139182,All three groups showed a significant improvement in EMG activity values and average QoL scores.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Özengin', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bakar', 'Affiliation': ''}, {'ForeName': 'Ö', 'Initials': 'Ö', 'LastName': 'Cinar Özdemir', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Duran', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
808,29734548,Effect of a low glycemic diet in patients with polycystic ovary syndrome and anovulation - a randomized controlled trial.,"OBJECTIVE


To determine whether a low glycemic index diet is better than a normal glycemic index diet in producing ovulatory cycles in women with polycystic ovary syndrome (PCOS) and anovulation.
MATERIALS AND METHODS


A randomized controlled clinical trial involving 37 women with PCOS and anovulation. The authors randomly assigned low glycemic index diets (n = 19) and normal glycemic index (n = 18) diets, and analyzed the number of ovulatory cycles for three months.
RESULTS


In patients who consumed a low glycemic index diet, 24.6% (14/57) of the cycles were ovulatory. In those who consumed a normal glycemic index diet, only 7.4% (4/54) of the cycles were ovulatory (p = 0.014).
CONCLUSIONS


The difference observed in the number of ovulatory cycles could be related to a decrease in the serum levels of circulating androgens, secondary to an improvement in insulin resistance.",2016,"In those who consumed a normal glycemic index diet, only 7.4% (4/54) of the cycles were ovulatory (p = 0.014).
","['37 women with PCOS and anovulation', 'women with polycystic ovary syndrome (PCOS) and anovulation', 'patients with polycystic ovary syndrome and anovulation ', 'patients who consumed a low glycemic index diet, 24.6% (14/57) of the cycles were ovulatory']","['normal glycemic index diet', 'normal glycemic index', 'low glycemic diet', 'low glycemic index diet', 'low glycemic index diets']","['insulin resistance', 'number of ovulatory cycles']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003128', 'cui_str': 'Anovulation'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}]",37.0,0.221163,"In those who consumed a normal glycemic index diet, only 7.4% (4/54) of the cycles were ovulatory (p = 0.014).
","[{'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Sordia-Hernández', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ancer Rodríguez', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Saldivar Rodriguez', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Trejo Guzman', 'Affiliation': ''}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Servín Zenteno', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Guerrero González', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ibarra Patiño', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
809,30441140,Correction of Toe-Walking Gait in Children with Spastic Cerebral Palsy by using Electrical Stimulation Therapy.,"Toe-walking is a very common gait abnormality seen in children with Cerebral Palsy (CP). The present study aims to improvise the toe-walking gait by applying Electrical Stimulation (ES) therapy of the Tricep Surae (TS) muscles. The study was carried out on sixteen children with spastic CP with unilateral toe-walking gait problem, divided into the intervention group that received both ES therapy along with conventional physiotherapy treatment and the control group that received only conventional physiotherapy treatment. Both groups were treated for 60 (30 + 30) minutes per day, for 5 days a week, up to 12 weeks. The gait data were analyzed for spatiotemporal and parameters influencing the walking capacity. The results showed that those children who received the intervention had a significant increase in gait speed by 17.67 % (p = 0.019) and decrease in stride length by 10.25 % (p = 0.037), resulting in improvement of body balance. There was a significant percentage increase in initial contact (heel strike) of 85.71 % (p = 0.000) and flat foot position (loading response) of 49.2 % (p = 0.005), confirming reduction in toe-walking. There was also an increase in the swing power by 39.8 % (p = 0.028) and ground impact by 19.5 % (p = 0.003) suggesting a change in foot contact pattern. The results indicate that ES therapy on TS muscle along with conventional physiotherapy may correct the toe-walking gait in children with spastic hemiplegic CP.",2018,"There was a significant percentage increase in initial contact (heel strike) of 85.71 % (p = 0.000) and flat foot position (loading response) of 49.2 % (p = 0.005), confirming reduction in toe-walking.","['children with Cerebral Palsy (CP', 'sixteen children with spastic CP with unilateral toe-walking gait problem', 'children with spastic hemiplegic CP', 'Children with Spastic Cerebral Palsy']","['conventional physiotherapy', 'ES therapy', 'toe-walking gait by applying Electrical Stimulation (ES) therapy of the Tricep Surae (TS) muscles', 'ES therapy along with conventional physiotherapy treatment and the control group that received only conventional physiotherapy treatment', 'Electrical Stimulation Therapy']","['flat foot position (loading response', 'initial contact (heel strike', 'gait speed', 'stride length', 'body balance', 'toe-walking gait', 'swing power']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0040357', 'cui_str': 'Toes'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0575081', 'cui_str': 'Gait difficulty'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0427144', 'cui_str': 'Toe-walking gait (finding)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C0224458', 'cui_str': 'Triceps surae muscle structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016202', 'cui_str': 'Splayfoot'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0038452', 'cui_str': 'Strikes'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0427144', 'cui_str': 'Toe-walking gait (finding)'}]",16.0,0.0180284,"There was a significant percentage increase in initial contact (heel strike) of 85.71 % (p = 0.000) and flat foot position (loading response) of 49.2 % (p = 0.005), confirming reduction in toe-walking.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mukhopadhyay', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mahadevappa', 'Affiliation': ''}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Lenka', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Biswas', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2018.8513043']
810,29891524,Early Versus Delayed Initiation of Salvage Androgen Deprivation Therapy and Risk of Prostate Cancer-Specific Mortality.,"Background:  This study sought to ascertain whether there is an association between prostate cancer (PC)-specific mortality (PCSM) and timing of salvage androgen deprivation therapy (ADT) among men with short versus long prostate-specific antigen doubling times (PSA-DTs).  Methods:  The study cohort was selected from 206 men with localized unfavorable-risk PC randomized to radiation therapy (RT) or RT plus 6 months of ADT between 1995 and 2001. A total of 54 men who received salvage ADT for PSA failure after a median follow-up of 18.72 years following randomization defined the study cohort. The Fine-Gray competing risks regression model was used to analyze whether the timing of salvage ADT was associated with an increased risk of PCSM after adjusting for age, comorbidity, known PC prognostic factors, and previously identified interactions.  Results:  After a median follow-up of 5.68 years (interquartile range, 3.05-9.56) following salvage ADT, 49 of the 54 men (91%) died, of which 27 from PC (54% of deaths). Increasing PSA-DT as a continuous covariate (per month increase) was associated with a decreasing risk of PCSM (adjusted hazard ratio [HR], 0.33; 95% CI, 0.13-0.82;  P =.02). Among men with a long PSA-DT (≥6 months), initiating salvage ADT later (PSA level >12 ng/mL, upper quartile) versus earlier was associated with an increased risk of PCSM (adjusted HR, 8.84; 95% CI, 1.99-39.27;  P =.004), whereas for those with a short PSA-DT (<6 months; adjusted HR, 1.16; 95% CI, 0.38-3.54;  P =.79) this was not true.  Conclusions:  Early initiation of salvage ADT for post-RT PSA failure in men with a PSA-DT of ≥6 months may reduce the risk of PCSM.",2018,"Increasing PSA-DT as a continuous covariate (per month increase) was associated with a decreasing risk of PCSM (adjusted hazard ratio [HR], 0.33; 95% CI, 0.13-0.82;  P =.02).","['men with a long PSA-DT (≥6 months), initiating salvage ADT later (PSA level', '54 men who received salvage ADT for PSA failure after a median follow-up of 18.72 years following randomization defined the study cohort', 'men with short versus long prostate-specific antigen doubling times (PSA-DTs', 'men with a PSA-DT of ≥6 months', '206 men with localized unfavorable-risk PC randomized to radiation therapy (RT) or RT plus 6 months of ADT between 1995 and 2001']","['Salvage Androgen Deprivation Therapy', 'salvage androgen deprivation therapy (ADT']",['risk of PCSM'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}]",54.0,0.0930591,"Increasing PSA-DT as a continuous covariate (per month increase) was associated with a decreasing risk of PCSM (adjusted hazard ratio [HR], 0.33; 95% CI, 0.13-0.82;  P =.02).","[{'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Mahal', 'Affiliation': ''}, {'ForeName': 'Ming-Hui', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Renshaw', 'Affiliation': ''}, {'ForeName': 'Marian J', 'Initials': 'MJ', 'LastName': 'Loffredo', 'Affiliation': ''}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Kantoff', 'Affiliation': ''}, {'ForeName': 'Anthony V', 'Initials': 'AV', 'LastName': ""D'Amico"", 'Affiliation': ''}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2018.7010']
811,31356878,Tropomyosin-related kinase A (TrkA) inhibition for the treatment of painful knee osteoarthritis: results from a randomized controlled phase 2a trial.,"OBJECTIVE


To investigate the TrkA inhibitor, ASP7962, for treatment of painful knee osteoarthritis.
DESIGN


Phase 2a, double-blind, placebo- and naproxen-controlled, double-dummy, parallel-group study. Adults with knee osteoarthritis were randomized (2:2:1) to ASP7962 (100 mg), placebo, or naproxen (500 mg) twice daily (BID) for 4 weeks. Primary endpoint: change from baseline to Week 4 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale score. Secondary endpoints: change from baseline to Weeks 1, 2, and End of Treatment (EoT) in WOMAC pain subscale score; change from baseline to Weeks 1, 2, 4, and EoT in WOMAC physical function and stiffness subscales, walking pain and WOMAC total scores; and change from baseline in daily average pain score.
RESULTS


215 participants were randomized (ASP7962 100 mg BID, n = 85; placebo, n = 87; naproxen 500 mg BID, n = 43). No significant difference was observed between ASP7962 and placebo in change from baseline to Week 4 in WOMAC pain subscale score (-0.14; 90% 2-sided CI: -0.62, 0.34; P = 0.316); a significant difference was observed between naproxen and placebo (-0.67; 80% 2-sided CI: -1.12, -0.23; P = 0.027). No differences were observed between ASP7962 and placebo in change from baseline in any WOMAC subscale score; statistically significant changes were observed between naproxen and placebo (P ≤ 0.01, all time points for all WOMAC endpoints). ASP7962 was safe and well-tolerated.
CONCLUSIONS


Four-week treatment with ASP7962 (100 mg BID) did not improve pain or physical function in individuals with painful knee osteoarthritis. ClinicalTrials.gov, NCT02611466; EudraCT Number, 2014-004996-22.",2019,"No significant difference was observed between ASP7962 and placebo in change from baseline to Week 4 in WOMAC pain subscale score (-0.14; 90% 2-sided CI: -0.62, 0.34; P = 0.316); a significant difference was observed between naproxen and placebo (-0.67; 80% 2-sided CI: -1.12, -0.23; P = 0.027).","['215 participants were', 'individuals with painful knee osteoarthritis', 'painful knee osteoarthritis', 'Adults with knee osteoarthritis']","['ASP7962', 'naproxen', 'placebo, or naproxen', 'placebo', 'TrkA inhibitor, ASP7962', 'randomized (ASP7962 100\xa0mg BID, n\xa0=\xa085; placebo, n\xa0=\xa087; naproxen', 'placebo- and naproxen', 'Tropomyosin-related kinase A (TrkA) inhibition', 'ASP7962 and placebo']","['baseline to Week 4 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale score', 'safe and well-tolerated', 'baseline to Weeks 1, 2, and End of Treatment (EoT) in WOMAC pain subscale score; change from baseline to Weeks 1, 2, 4, and EoT in WOMAC physical function and stiffness subscales, walking pain and WOMAC total scores; and change from baseline in daily average pain score', 'WOMAC subscale score', 'WOMAC pain subscale score', 'pain or physical function']","[{'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C0041197', 'cui_str': 'Tropomyosin'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",215.0,0.460245,"No significant difference was observed between ASP7962 and placebo in change from baseline to Week 4 in WOMAC pain subscale score (-0.14; 90% 2-sided CI: -0.62, 0.34; P = 0.316); a significant difference was observed between naproxen and placebo (-0.67; 80% 2-sided CI: -1.12, -0.23; P = 0.027).","[{'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Watt', 'Affiliation': 'Centre for Osteoarthritis Pathogenesis Versus Arthritis, Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Roosevelt Drive Headington, Oxford, UK. Electronic address: fiona.watt@kennedy.ox.ac.uk.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Blauwet', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, IL, USA. Electronic address: MaryBeth.Blauwet@Astellas.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fakhoury', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, IL, USA. Electronic address: Al.Fakhoury@astellas.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jacobs', 'Affiliation': 'Formerly with Astellas Pharma Global Development, Leiden, the Netherlands. Electronic address: helenejacobs@hotmail.com.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Smulders', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, IL, USA. Electronic address: Ronald.Smulders@astellas.com.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Lane', 'Affiliation': 'Center for Musculoskeletal Health, University of California at Davis Medical Center, Sacramento, CA, USA. Electronic address: nelane@ucdavis.edu.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2019.05.029']
812,29653629,"Oral doxycycline for the prevention of postoperative trachomatous trichiasis in Ethiopia: a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Trachomatous trichiasis is treated surgically to prevent sight loss. Unfavourable surgical outcomes remain a major challenge. We investigated the hypothesis that doxycycline might reduce the risk of postoperative trichiasis following surgery in patients with trachomatous trichiasis through anti-matrix metalloproteinase and anti-inflammatory activity.
METHODS


In this randomised, double-blind, placebo-controlled trial, adults (aged >18 years) with upper lid trachomatous trichiasis in association with tarsal conjunctive scarring were recruited through community-based screening and surgical outreach campaigns in Ethiopia. Individuals who had previously had eyelid surgery were excluded. Participants were randomly assigned (1:1), with random block sizes of four or six, to receive oral doxycycline (100 mg once a day) or placebo for 28 days immediately after trichiasis surgery. Randomisation was stratified by surgeon. Patients, investigators, surgeons, and all other study team members were masked to study group allocation and treatment. Participants were examined at 10 days, and 1, 6, and 12 months after surgery. The primary outcome was the cumulative proportion of individuals who developed postoperative trichiasis by 12 months. Primary analyses were done in all participants who attended at least one of the four follow-up assessments. Safety analyses were done in all participants who attended either the 10 day or 1 month follow-up assessments. This trial is registered with the Pan African Clinical Trials Registry, number PACTR201512001370307.
FINDINGS


Between Dec 21, 2015, and April 6, 2016, 1000 patients with trichiasis were enrolled and randomly assigned to treatment (499 patients to doxycycline, 501 patients to placebo). All but one participant attended at least one follow-up assessment. Thus, 999 participants were assessed for the primary outcome: 498 in the doxycycline group and 501 in the placebo group. By month 12, 58 (12%) of 498 patients in the doxycycline group and 62 (12%) of 501 patients in the placebo group had developed postoperative trichiasis (adjusted odds ratio 0·91, 95% CI 0·61 to 1·34, p=0·63), with a risk difference of -0·5% (-4·5% to 3·5%). Significantly more patients in the doxycycline group had an adverse event than in the placebo group (18 [4%] of 498 vs six [1%] of 501; odds ratio 3·09, 95% CI 1·21-7·84; p=0·02). The most frequent adverse events in the doxycycline group were gastritis symptoms (n=9), constipation (n=4), and diarrhoea (n=4).
INTERPRETATION


Doxycycline did not reduce the risk of postoperative trichiasis and is therefore not indicated for the improvement of outcomes following trachomatous trichiasis surgery. Surgical programmes should continue to make efforts to strengthen surgical training and supervision to improve outcomes.
FUNDING


The Wellcome Trust.",2018,"Significantly more patients in the doxycycline group had an adverse event than in the placebo group (18 [4%] of 498 vs six [1%] of 501; odds ratio 3·09, 95% CI 1·21-7·84; p=0·02).","['Ethiopia', '1000 patients with trichiasis', 'Individuals who had previously had eyelid surgery were excluded', '999 participants were assessed for the primary outcome: 498 in the doxycycline group and 501 in the placebo group', 'adults (aged >18 years) with upper lid trachomatous trichiasis in association with tarsal conjunctive scarring were recruited through community-based screening and surgical outreach campaigns in Ethiopia']","['placebo', 'Doxycycline', 'oral doxycycline', 'doxycycline', 'Oral doxycycline']","['adverse event', 'gastritis symptoms', 'postoperative trichiasis', 'cumulative proportion of individuals who developed postoperative trichiasis']","[{'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221259', 'cui_str': 'Trichiasis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017152', 'cui_str': 'Gastritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0221259', 'cui_str': 'Trichiasis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",1000.0,0.763934,"Significantly more patients in the doxycycline group had an adverse event than in the placebo group (18 [4%] of 498 vs six [1%] of 501; odds ratio 3·09, 95% CI 1·21-7·84; p=0·02).","[{'ForeName': 'Esmael', 'Initials': 'E', 'LastName': 'Habtamu', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene & Tropical Medicine, London, UK. Electronic address: esmael.ali@lshtm.ac.uk.'}, {'ForeName': 'Tariku', 'Initials': 'T', 'LastName': 'Wondie', 'Affiliation': 'The Carter Center, Addis Ababa, Ethiopia.'}, {'ForeName': 'Sintayehu', 'Initials': 'S', 'LastName': 'Aweke', 'Affiliation': 'The Carter Center, Addis Ababa, Ethiopia.'}, {'ForeName': 'Zerihun', 'Initials': 'Z', 'LastName': 'Tadesse', 'Affiliation': 'The Carter Center, Addis Ababa, Ethiopia.'}, {'ForeName': 'Mulat', 'Initials': 'M', 'LastName': 'Zerihun', 'Affiliation': 'The Carter Center, Addis Ababa, Ethiopia.'}, {'ForeName': 'Bizuayehu', 'Initials': 'B', 'LastName': 'Gashaw', 'Affiliation': 'Amhara Regional Health Bureau, Bahirdar, Ethiopia.'}, {'ForeName': 'Chrissy H', 'Initials': 'CH', 'LastName': 'Roberts', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Amir Bedri', 'Initials': 'AB', 'LastName': 'Kello', 'Affiliation': 'Light for the World, Addis Ababa, Ethiopia.'}, {'ForeName': 'David C W', 'Initials': 'DCW', 'LastName': 'Mabey', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Rajak', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'E Kelly', 'Initials': 'EK', 'LastName': 'Callahan', 'Affiliation': 'The Carter Center, Atlanta, GA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Macleod', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Burton', 'Affiliation': 'International Centre for Eye Health, London School of Hygiene & Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(18)30111-6']
813,31377075,"Randomized, single-blind, active-controlled phase I clinical trial to evaluate the immunogenicity and safety of GC3114 (high-dose, quadrivalent influenza vaccine) in healthy adults.","Influenza is a major medically attended respiratory illness. The impact of influenza on morbidity and mortality is particularly high in the elderly. Immunosenescence attenuates the immune response of influenza vaccine in the elderly. High-dose influenza vaccine contains 60 μg of hemagglutinin per strain, four times more compared with standard-dose (SD) influenza vaccine. This study is a phase I clinical trial investigating the immunogenicity and safety of the GC3114, high-dose, quadrivalent inactivated influenza vaccine (HD-QIV) in healthy adults aged 19-64 years during the 2017-2018 season. Seroprotection rates of HD-QIV were 100.0% for A/H1N1, 96.67% for A/H3N2, 83.33% for B/Yamagata, and 96.67% for B/Victoria. Seroconversion rate for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 86.67%, 90.0%, 53.33%, and 53.33%, respectively, in the HD-QIV group. The post-/pre-vaccination geometric mean titer ratio (GMTR) was 15.28 for A/H1N1, 8.19 for A/H3N2, 3.56 for B/Yamagata, and 3.03 for B/Victoria in the HD-QIV group. Seroconversion rate and post-/pre-vaccination GMTR for A/H3N2 were significantly higher in the HD-QIV group than in the SD-QIV group (control). No serious adverse events were reported. In conclusion, GC3114 was safe, well-tolerated, and immunogenic in healthy adults. Clinical Trials Identifier: NCT03357263.",2019,Seroconversion rate and post-/pre-vaccination GMTR for A/H3N2 were significantly higher in the HD-QIV group than in the SD-QIV group (control).,"['healthy adults', 'healthy adults aged 19-64\u202fyears during the 2017-2018 season']","['GC3114', 'GC3114 (high-dose, quadrivalent influenza vaccine', 'GC3114, high-dose, quadrivalent inactivated influenza vaccine (HD-QIV', 'Immunosenescence']","['Seroprotection rates of HD-QIV', 'post-/pre-vaccination geometric mean titer ratio (GMTR', 'Seroconversion rate', 'morbidity and mortality', 'serious adverse events', 'Seroconversion rate and post-/pre-vaccination GMTR']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0596761', 'cui_str': 'Immunosenescence'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2018.0,0.0590526,Seroconversion rate and post-/pre-vaccination GMTR for A/H3N2 were significantly higher in the HD-QIV group than in the SD-QIV group (control).,"[{'ForeName': 'Ji Yun', 'Initials': 'JY', 'LastName': 'Noh', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ye Seul', 'Initials': 'YS', 'LastName': 'Jang', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Saem Na', 'Initials': 'SN', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Min Joo', 'Initials': 'MJ', 'LastName': 'Choi', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Gu', 'Initials': 'JG', 'LastName': 'Yoon', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Du Hyeon', 'Initials': 'DH', 'LastName': 'Yu', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joon Young', 'Initials': 'JY', 'LastName': 'Song', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Jin', 'Initials': 'HJ', 'LastName': 'Cheong', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Woo Joo', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea; Asia Pacific Influenza Institute, Korea University College of Medicine, Seoul, Republic of Korea. Electronic address: wjkim@korea.ac.kr.'}]",Vaccine,['10.1016/j.vaccine.2019.07.076']
814,29714858,Delayed umbilical cord clamping in cesarean section reduces postpartum bleeding and the rate of severe asphyxia.,"PURPOSE OF INVESTIGATION


To explore the effect of delayed umbilical cord clamping in cesarean section on outcomes of mothers and newborns.
MATERIALS AND METHODS


A total of 338 pregnant women under cesarean section were randomly divided into two groups: study group with delayed umbilical cord clamping after pulsation loss, and control group with early clamping within 60 seconds after birth.
RESULTS


There were no significant differences in hemoglobin and hematocrit in newborn cord blood, the highest bilirubin after birth, Apgar scores at one and five minutes after birth, and in the occurrence of neonatal hyperbilirubinemia or application of phototherapy. There were significant differences in placental residual blood, the amount of postpartum bleeding, hemoglobin and hematocrit in newborn heel blood, and the rate of neonatal resuscitation after ten minutes in both groups.
CONCLUSION


Umbilical cord clamping should be employed after pulsation loss to avoid adverse effect of early clamping.",2017,"There were significant differences in placental residual blood, the amount of postpartum bleeding, hemoglobin and hematocrit in newborn heel blood, and the rate of neonatal resuscitation after ten minutes in both groups.
","['338 pregnant women under cesarean section', 'mothers and newborns']","['delayed umbilical cord clamping after pulsation loss, and control group with early clamping within 60 seconds after birth', 'delayed umbilical cord clamping', 'Delayed umbilical cord clamping in cesarean section']","['placental residual blood, the amount of postpartum bleeding, hemoglobin and hematocrit in newborn heel blood, and the rate of neonatal resuscitation', 'postpartum bleeding and the rate of severe asphyxia', 'hemoglobin and hematocrit in newborn cord blood, the highest bilirubin after birth, Apgar scores']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0405737', 'cui_str': 'Umbilical cord clamping (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004044', 'cui_str': 'Suffocation'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}]",338.0,0.0349838,"There were significant differences in placental residual blood, the amount of postpartum bleeding, hemoglobin and hematocrit in newborn heel blood, and the rate of neonatal resuscitation after ten minutes in both groups.
","[{'ForeName': 'Meiling', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Xianglan', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Shan', 'Affiliation': ''}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
815,29714864,Long-term results of tension-free vaginal tape and pubovaginal sling in the treatment of stress urinary incontinence in female patients.,"OBJECTIVES


To report the long-term outcome of tension-free vaginal tape (TVT) and pubovaginal sling (PVS) in the treatment of stress urinary incontinence (SUI) in female patients.
MATERIALS AND METHODS


The long-term objective and subjective results of female patients who were previously randomized in a single blind study to two arms, TVT or PVS, between 2000 and 2004, were evaluated. The patients were asked if they were satisfied with the results of the procedure and if they would recommend it to a friend or relative. The assessment included a physical examination and cough-induced stress test. Satisfaction levels were assessed by Likert-type scale. Cure was described as absence of urine leakage in any circumstances, while improvement was characterized as subjective improvement of SUI without complete resolution.
RESULTS


One hundred women with SUI underwent surgery at the present medical center between 2000 and 2004. A total of 52 patients were followed clinically for objective and subjective assessment. Seventeen were interviewed only by telephone. The objective cure rate was 81.5% and 84%, where as subjective cure rate was 70.3% and 71.9%, for TVT versus PVS, respectively (p > 0.05). After an average follow-up of 10.5 years, there was no difference in clinical outcome, satisfaction scores, and postoperative complications between the two groups.
CONCLUSION


Both TVT and PVS are safe and effective treatments for SUI in fe- male patients, with acceptable success rate in long term follow-up.",2017,"After an average follow-up of 10.5 years, there was no difference in clinical outcome, satisfaction scores, and postoperative complications between the two groups.
","['stress urinary incontinence (SUI) in female patients', 'One hundred women with SUI underwent surgery at the present medical center between 2000 and 2004', 'female patients', 'female patients who were previously randomized in a single blind study to two arms, TVT or PVS, between 2000 and 2004, were evaluated']","['tension-free vaginal tape (TVT) and pubovaginal sling (PVS', 'TVT and PVS', 'tension-free vaginal tape and pubovaginal sling']","['objective cure rate', 'physical examination and cough-induced stress test', 'stress urinary incontinence', 'subjective cure rate', 'Satisfaction levels', 'clinical outcome, satisfaction scores, and postoperative complications']","[{'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1721083', 'cui_str': 'Tension-Free Vaginal Tape'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",52.0,0.0330216,"After an average follow-up of 10.5 years, there was no difference in clinical outcome, satisfaction scores, and postoperative complications between the two groups.
","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sharifiaghdas', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mirzaei', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Daneshpajooh', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Narouie', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
816,29446069,Accelerated Development of the Dual Orexin Receptor Antagonist ACT-541468: Integration of a Microtracer in a First-in-Human Study.,"The orexin system regulates sleep and arousal and is targeted by ACT-541468, a new dual orexin receptor antagonist (DORA). Healthy male subjects received a single oral dose of 5-200 mg to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), mass balance, metabolism, and absolute bioavailability utilizing a  14  C-labeled, orally and intravenously (i.v.) administered microtracer. The drug was safe and well tolerated; the PK profile was characterized by quick absorption and elimination, with median time to reach maximum concentration (t max  ) of 0.8-2.8 h and geometric mean terminal half-life (t 1/2  ) of 5.9-8.8 h. Clear dose-related effects on the central nervous system were observed at ≥25 mg, indicating a suitable PK-PD profile for a sleep-promoting drug, allowing for rapid onset and duration of action limited to the intended use. This comprehensive first-in-human study created a wealth of data, while saving resources in drug development.",2018,"The orexin system regulates sleep and arousal and is targeted by ACT-541468, a new dual orexin receptor antagonist (DORA).",['Healthy male subjects'],['Dual Orexin Receptor Antagonist'],"['safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), mass balance, metabolism, and absolute bioavailability', 'safe and well tolerated']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}]",,0.035041,"The orexin system regulates sleep and arousal and is targeted by ACT-541468, a new dual orexin receptor antagonist (DORA).","[{'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Muehlan', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Jules', 'Initials': 'J', 'LastName': 'Heuberger', 'Affiliation': 'Centre for Human Drug Research (CHDR), Leiden, The Netherlands.'}, {'ForeName': 'Pierre-Eric', 'Initials': 'PE', 'LastName': 'Juif', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Croft', 'Affiliation': 'Xceleron (a Pharmaron Company), Germantown, Maryland, USA.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'van Gerven', 'Affiliation': 'Centre for Human Drug Research (CHDR), Leiden, The Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1046']
817,29714870,Maintenance of the parturient in the left lateral position after spinal anesthesia with plain levobupivacaine for cesarean section reduces hypotension: a randomized study.,"PURPOSE OF INVESTIGATION


Hypotension during spinal anesthesia is a main concern in cesarean delivery. The authors hypothesized that keeping parturients in a prolonged left lateral position before turning them to a supine position with left lateral tilt would reduce the incidence of hypotension without jeopardizing the quality of anesthesia.
MATERIALS AND METHODS


Randomized comparative unblinded prospective study. This randomized comparative prospective study was conducted at Gaziantep University Hospital between June and December 2011. Sixty parturients undergoing cesarean section were included. Patients were randomized to two groups: turning to the supine position with left lateral tilt immediately or 15 minutes after subarachnoid injection of 2.5 ml 0.5% plain levobupivacaine in the left lateral position. Loss of pinprick sensation to T6 was accepted as adequate for cesarean section, and surgery proceeded. Characteristics of anesthesia; incidences of hypotension, bradycardia, and other adverse events, and ephedrine use were assessed.
RESULTS


Compared with the supine group, parturients kept in a lateral position for 15 minutes showed marked reductions in the incidence of hypotension (33.3% vs. 83.3%, p < 0.001) and adverse events related to hypotension, such as nausea and vomiting (16.7% vs. 57.3%, p <0.001). In addition, ephedrine consumption per hypotension case was significantly reduced in the lateral group (5.4 ± 4.7 vs. 8.9 ± 5.8 mg; p < 0.00 1).
CONCLUSIONS


Keeping parturients in the lateral position for 15 minutes before turning them to the supine position for cesarean section can provide reliable spinal anesthesia with a lower incidence and severity of hypotension and nausea/vomiting.",2017,"Compared with the supine group, parturients kept in a lateral position for 15 minutes showed marked reductions in the incidence of hypotension (33.3% vs. 83.3%, p < 0.001) and adverse events related to hypotension, such as nausea and vomiting (16.7% vs. 57.3%, p <0.001).","['Gaziantep University Hospital between June and December 2011', 'Sixty parturients undergoing cesarean section were included']","['plain levobupivacaine', 'supine position with left lateral tilt immediately or 15 minutes after subarachnoid injection of 2.5 ml 0.5% plain levobupivacaine']","['nausea and vomiting', 'hypotension', 'Loss of pinprick sensation', 'hypotension and nausea/vomiting', 'ephedrine consumption per hypotension case', 'hypotension, bradycardia, and other adverse events, and ephedrine use', 'incidence of hypotension']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0038846', 'cui_str': 'Dorsal Position'}, {'cui': 'C1532124', 'cui_str': 'Left lateral tilt'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",60.0,0.0388801,"Compared with the supine group, parturients kept in a lateral position for 15 minutes showed marked reductions in the incidence of hypotension (33.3% vs. 83.3%, p < 0.001) and adverse events related to hypotension, such as nausea and vomiting (16.7% vs. 57.3%, p <0.001).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sahin', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cesur', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sahin', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kilic', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sen', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
818,31630990,"Immunogenicity of chimeric haemagglutinin-based, universal influenza virus vaccine candidates: interim results of a randomised, placebo-controlled, phase 1 clinical trial.","BACKGROUND


Influenza viruses cause substantial annual morbidity and mortality globally. Current vaccines protect against influenza only when well matched to the circulating strains. However, antigenic drift can cause considerable mismatches between vaccine and circulating strains, substantially reducing vaccine effectiveness. Moreover, current seasonal vaccines are ineffective against pandemic influenza, and production of a vaccine matched to a newly emerging virus strain takes months. Therefore, there is an unmet medical need for a broadly protective influenza virus vaccine. We aimed to test the ability of chimeric H1 haemagglutinin-based universal influenza virus vaccine candidates to induce broadly cross-reactive antibodies targeting the stalk domain of group 1 haemagglutinin-expressing influenza viruses.
METHODS


We did a randomised, observer-blinded, phase 1 study in healthy adults in two centres in the USA. Participants were randomly assigned to one of three prime-boost, chimeric haemagglutinin-based vaccine regimens or one of two placebo groups. The vaccine regimens included a chimeric H8/1, intranasal, live-attenuated vaccine on day 1 followed by a non-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine on day 85; the same regimen but with the inactivated vaccine being adjuvanted with AS03; and an AS03-adjuvanted, chimeric H8/1, intramuscular, inactivated vaccine followed by an AS03-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine. In this planned interim analysis, the primary endpoints of reactogenicity and safety were assessed by blinded study group. We also assessed anti-H1 haemagglutinin stalk, anti-H2, anti-H9, and anti-H18 IgG antibody titres and plasmablast and memory B-cell responses in peripheral blood. This trial is registered with ClinicalTrials.gov, number NCT03300050.
FINDINGS


Between Oct 10, 2017, and Nov 27, 2017, 65 participants were enrolled and randomly assigned. The adjuvanted inactivated vaccine, but not the live-attenuated vaccine, induced a substantial serum IgG antibody response after the prime immunisation, with a seven times increase in anti-H1 stalk antibody titres on day 29. After boost immunisation, all vaccine regimens induced detectable anti-H1 stalk antibody (2·2-5·6 times induction over baseline), cross-reactive serum IgG antibody, and peripheral blood plasmablast responses. An unsolicited adverse event was reported for 29 (48%) of 61 participants. Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo. Solicited systemic adverse events were reported in 14 (56%) of 25 after prime immunisation with intramuscular study product or placebo, in 22 (61%) of 36 after immunisation with intranasal study product or placebo, and in 21 (38%) of 56 after booster doses of study product or placebo. Disaggregated safety data were not available at the time of this interim analysis.
INTERPRETATION


The tested chimeric haemagglutinin-based, universal influenza virus vaccine regimens elicited cross-reactive serum IgG antibodies that targeted the conserved haemagglutinin stalk domain. This is the first proof-of-principle study to show that high anti-stalk titres can be induced by a rationally designed vaccine in humans and opens up avenues for further development of universal influenza virus vaccines. On the basis of the blinded study group, the vaccine regimens were tolerable and no safety concerns were observed.
FUNDING


Bill & Melinda Gates Foundation.",2020,"Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo.","['healthy adults in two centres in the USA', 'peripheral blood', 'Between Oct 10, 2017, and Nov 27, 2017, 65 participants were enrolled and randomly assigned']","['placebo', 'chimeric haemagglutinin-based vaccine regimens or one of two placebo', 'chimeric H8/1, intranasal, live-attenuated vaccine', 'inactivated vaccine being adjuvanted with AS03; and an AS03-adjuvanted, chimeric H8/1, intramuscular, inactivated vaccine followed by an AS03-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine']","['Solicited systemic adverse events', 'detectable anti-H1 stalk antibody (2·2-5·6 times induction over baseline), cross-reactive serum IgG antibody, and peripheral blood plasmablast responses', 'tolerable and no safety concerns', 'anti-H1 stalk antibody titres', 'reactogenicity and safety', 'anti-H1 haemagglutinin stalk, anti-H2, anti-H9, and anti-H18 IgG antibody titres and plasmablast and memory B-cell responses', 'vaccine effectiveness', 'Solicited local adverse events', 'substantial serum IgG antibody response']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0935572', 'cui_str': 'Stalkings'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0229657', 'cui_str': 'Plasmablast (cell)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",65.0,0.338098,"Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Guptill', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Naficy', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Raffael', 'Initials': 'R', 'LastName': 'Nachbagauer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Berlanda-Scorza', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Feser', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Wilson', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA; The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Solórzano', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Van der Wielen', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Walter', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA; Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Randy A', 'Initials': 'RA', 'LastName': 'Albrecht', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Buschle', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Yao-Qing', 'Initials': 'YQ', 'LastName': 'Chen', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Claeys', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dickey', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Haley L', 'Initials': 'HL', 'LastName': 'Dugan', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Ermler', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gast', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Jenna J', 'Initials': 'JJ', 'LastName': 'Guthmiller', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Hai', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Microbiology and Plant Pathology, Institute for Integrative Genome Biology, University of California, Riverside, CA, USA.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Henry', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Linda Yu-Ling', 'Initials': 'LY', 'LastName': 'Lan', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Anna-Karin E', 'Initials': 'AE', 'LastName': 'Palm', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dustin G', 'Initials': 'DG', 'LastName': 'Shaw', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Stamper', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Weina', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Sutton', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Micah E', 'Initials': 'ME', 'LastName': 'Tepora', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rahnuma', 'Initials': 'R', 'LastName': 'Wahid', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Wenzel', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Teddy John', 'Initials': 'TJ', 'LastName': 'Wohlbold', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Innis', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'García-Sastre', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Palese', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krammer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: florian.krammer@mssm.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30393-7']
819,29171829,Effect of patient decision aid was influenced by presurgical evaluation among patients with osteoarthritis of the knee.,"BACKGROUND


Decision aids help patients make total joint arthroplasty decisions, but presurgical evaluation might influence the effects of a decision aid. We compared the effects of a decision aid among patients considering total knee arthroplasty at 2 surgical screening clinics with different evaluation processes.
METHODS


We performed a subgroup analysis of a randomized controlled trial. Patients were recruited from 2 surgical screening clinics: an academic clinic providing 20-minute physician consultations and a community clinic providing 45-minute physiotherapist/nurse consultations with education. We compared the effects of decision quality, decisional conflict and surgery rate using Cochran-Mantel-Haenszel χ 2  tests and the Breslow-Day test.
RESULTS


We evaluated 242 patients: 123 from the academic clinic (61 who used the decision aid and 62 controls) and 119 from the community clinic (59 who used the decision aid and 60 controls). Results suggested a between-site difference in the effect of the decision aid on the patients' decision quality ( p  = 0.09): at the academic site, patients who used the decision were more likely to make better-quality decisions than controls (54% v. 35%,  p  = 0.044), but not at the community site (47% v. 51%,  p  = 0.71). Fewer patients who used decision aids at the academic site than at the community site experienced decisional conflict ( p  = 0.007) (33% v. 52%,  p  = 0.05 at the academic site and 40% v. 24%,  p  = 0.08 at the community site). The effect of the decision aid on surgery rates did not differ between sites ( p  = 0.65).
CONCLUSION


The decision aid had a greater effect at the academic site than at the community site, which provided longer consultations with more verbal education. Hence, decision aids might be of greater value when more extensive total knee arthroplasty presurgical assessment and counselling are either impractical or unavailable.",2018,"Fewer patients who used decision aids at the academic site than at the community site experienced decisional conflict ( p  = 0.007) (33% v. 52%,  p  = 0.05 at the academic site and 40% v. 24%,  p  = 0.08 at the community site).","['patients with osteoarthritis of the knee', 'patients considering total knee arthroplasty at 2 surgical screening clinics with different evaluation processes', '242 patients: 123 from the academic clinic (61 who used the decision aid and 62 controls) and 119 from the community clinic (59 who used the decision aid and 60 controls', 'Patients were recruited from 2 surgical screening clinics: an academic clinic providing 20-minute physician consultations and a community clinic providing 45-minute physiotherapist/nurse consultations with education']",[],"['decisional conflict', 'decision quality, decisional conflict and surgery rate', 'quality decisions', 'surgery rates', ""patients' decision quality""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0587907', 'cui_str': 'Community clinic (environment)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],"[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",242.0,0.0494246,"Fewer patients who used decision aids at the academic site than at the community site experienced decisional conflict ( p  = 0.007) (33% v. 52%,  p  = 0.05 at the academic site and 40% v. 24%,  p  = 0.08 at the community site).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Boland', 'Affiliation': 'From the University of Ottawa, Ottawa, Ont. (Boland, Tugwell, Stacey); the Patient Decision Aid Research Group, Ottawa Hospital Research Institute, Ottawa, Ont. (Boland, Dervin, Trenaman, Stacey); the Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ont. (Taljaard); the School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ont. (Taljaard); the Ottawa Hospital Research Institute, Ottawa, Ont. (Dervin, Tugwell); the University of British Columbia, Vancouver, BC (Trenaman); and the School of Public Health, University of Montréal, Montréal, Que. (Pomey).'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'From the University of Ottawa, Ottawa, Ont. (Boland, Tugwell, Stacey); the Patient Decision Aid Research Group, Ottawa Hospital Research Institute, Ottawa, Ont. (Boland, Dervin, Trenaman, Stacey); the Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ont. (Taljaard); the School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ont. (Taljaard); the Ottawa Hospital Research Institute, Ottawa, Ont. (Dervin, Tugwell); the University of British Columbia, Vancouver, BC (Trenaman); and the School of Public Health, University of Montréal, Montréal, Que. (Pomey).'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Dervin', 'Affiliation': 'From the University of Ottawa, Ottawa, Ont. (Boland, Tugwell, Stacey); the Patient Decision Aid Research Group, Ottawa Hospital Research Institute, Ottawa, Ont. (Boland, Dervin, Trenaman, Stacey); the Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ont. (Taljaard); the School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ont. (Taljaard); the Ottawa Hospital Research Institute, Ottawa, Ont. (Dervin, Tugwell); the University of British Columbia, Vancouver, BC (Trenaman); and the School of Public Health, University of Montréal, Montréal, Que. (Pomey).'}, {'ForeName': 'Logan', 'Initials': 'L', 'LastName': 'Trenaman', 'Affiliation': 'From the University of Ottawa, Ottawa, Ont. (Boland, Tugwell, Stacey); the Patient Decision Aid Research Group, Ottawa Hospital Research Institute, Ottawa, Ont. (Boland, Dervin, Trenaman, Stacey); the Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ont. (Taljaard); the School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ont. (Taljaard); the Ottawa Hospital Research Institute, Ottawa, Ont. (Dervin, Tugwell); the University of British Columbia, Vancouver, BC (Trenaman); and the School of Public Health, University of Montréal, Montréal, Que. (Pomey).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tugwell', 'Affiliation': 'From the University of Ottawa, Ottawa, Ont. (Boland, Tugwell, Stacey); the Patient Decision Aid Research Group, Ottawa Hospital Research Institute, Ottawa, Ont. (Boland, Dervin, Trenaman, Stacey); the Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ont. (Taljaard); the School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ont. (Taljaard); the Ottawa Hospital Research Institute, Ottawa, Ont. (Dervin, Tugwell); the University of British Columbia, Vancouver, BC (Trenaman); and the School of Public Health, University of Montréal, Montréal, Que. (Pomey).'}, {'ForeName': 'Marie-Pascale', 'Initials': 'MP', 'LastName': 'Pomey', 'Affiliation': 'From the University of Ottawa, Ottawa, Ont. (Boland, Tugwell, Stacey); the Patient Decision Aid Research Group, Ottawa Hospital Research Institute, Ottawa, Ont. (Boland, Dervin, Trenaman, Stacey); the Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ont. (Taljaard); the School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ont. (Taljaard); the Ottawa Hospital Research Institute, Ottawa, Ont. (Dervin, Tugwell); the University of British Columbia, Vancouver, BC (Trenaman); and the School of Public Health, University of Montréal, Montréal, Que. (Pomey).'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Stacey', 'Affiliation': 'From the University of Ottawa, Ottawa, Ont. (Boland, Tugwell, Stacey); the Patient Decision Aid Research Group, Ottawa Hospital Research Institute, Ottawa, Ont. (Boland, Dervin, Trenaman, Stacey); the Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ont. (Taljaard); the School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ont. (Taljaard); the Ottawa Hospital Research Institute, Ottawa, Ont. (Dervin, Tugwell); the University of British Columbia, Vancouver, BC (Trenaman); and the School of Public Health, University of Montréal, Montréal, Que. (Pomey).'}]",Canadian journal of surgery. Journal canadien de chirurgie,['10.1503/cjs.003316']
820,29477307,"Evaluation of vaccine derived poliovirus type 2 outbreak response options: A randomized controlled trial, Karachi, Pakistan.","BACKGROUND


Outbreaks of circulating vaccine derived polioviruses type 2 (cVDPV2) remain a risk to poliovirus eradication in an era without live poliovirus vaccine containing type 2 in routine immunization. We evaluated existing outbreak response strategies recommended by the World Health Organization (WHO) for control of cVDPV2 outbreaks.
METHODS


Seronegative children for poliovirus type 2 (PV2) at 22 weeks of life were assigned to one of four study groups and received respectively (1) one dose of trivalent oral poliovirus vaccine (tOPV); (2) monovalent OPV 2 (mOPV2); (3) tOPV together with a dose of inactivated poliovirus vaccine (IPV); or (4) mOPV2 with monovalent high-potency IPV type 2. Stool and blood samples were collected and assessed for presence of PV2 (stool) and anti-polio antibodies (sera).
RESULTS


We analyzed data from 265 children seronegative for PV2. Seroconversion to PV2 was achieved in 48, 76, 98 and 100% in Groups 1-4 respectively. mOPV2 was more immunogenic than tOPV alone (p < 0.001); and OPV in combination with IPV was more immunogenic than OPV alone (p < 0.001). There were 33%, 67%, 20% and 43% PV2 excretors in Groups 1-4 respectively. mOPV2 resulted in more prevalent shedding of PV2 than when tOPV was used (p < 0.001); and tOPV together with IPV resulted in lower excretion of PV2 than tOPV alone (p = 0.046).
CONCLUSION


mOPV2 was a more potent vaccine than tOPV. Adding IPV to OPV improved immunological response; adding IPV also seemed to have shortened the duration of PV2 shedding. mIPV2 did not provide measurable improvement of immune response when compared to conventional IPV. WHO recommendation to use mOPV2 as a vaccine of first choice in cVDPV2 outbreak response was supported by our findings. Clinical Trial registry number: NCT02189811.",2018,"mOPV2 resulted in more prevalent shedding of PV2 than when tOPV was used (p < 0.001); and tOPV together with IPV resulted in lower excretion of PV2 than tOPV alone (p = 0.046).
","['265 children seronegative for PV2', 'Seronegative children for poliovirus type 2 (PV2) at 22\u202fweeks of life']","['trivalent oral poliovirus vaccine (tOPV', 'inactivated poliovirus vaccine (IPV); or (4) mOPV2 with monovalent high-potency IPV type 2']","['prevalent shedding of PV2', 'lower excretion of PV2', 'Seroconversion to PV2', 'immune response', 'presence of PV2 (stool) and anti-polio antibodies (sera', 'Stool and blood samples']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C4521691', 'cui_str': 'US Military enlisted E2'}, {'cui': 'C0206433', 'cui_str': 'Human poliovirus 2'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}, {'cui': 'C0718003', 'cui_str': 'Poliovirus Vaccine, Inactivated'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C4521691', 'cui_str': 'US Military enlisted E2'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",265.0,0.0711563,"mOPV2 resulted in more prevalent shedding of PV2 than when tOPV was used (p < 0.001); and tOPV together with IPV resulted in lower excretion of PV2 than tOPV alone (p = 0.046).
","[{'ForeName': 'Ali Faisal', 'Initials': 'AF', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan. Electronic address: ali.saleem@aku.edu.'}, {'ForeName': 'Mohammad Tahir', 'Initials': 'MT', 'LastName': 'Yousafzai', 'Affiliation': 'Aga Khan University, Karachi, Pakistan. Electronic address: tahir.yousafzai@aku.edu.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Mach', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Farheen', 'Initials': 'F', 'LastName': 'Quadri', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Weldon', 'Affiliation': 'Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'M Steven', 'Initials': 'MS', 'LastName': 'Oberste', 'Affiliation': 'Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, USA.'}, {'ForeName': 'Syed S', 'Initials': 'SS', 'LastName': 'Zaidi', 'Affiliation': 'National Institute of Health, Islamabad, Pakistan.'}, {'ForeName': 'Muhammad M', 'Initials': 'MM', 'LastName': 'Alam', 'Affiliation': 'National Institute of Health, Islamabad, Pakistan.'}, {'ForeName': 'Roland W', 'Initials': 'RW', 'LastName': 'Sutter', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Anita K M', 'Initials': 'AKM', 'LastName': 'Zaidi', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}]",Vaccine,['10.1016/j.vaccine.2018.02.051']
821,31862174,Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial.,"INTRODUCTION


The effect of intensive blood pressure control upon erectile function in men with hypertension, but without diabetes, is largely unknown.
AIM


To examine the effects of intensive systolic blood pressure (SBP) lowering on erectile function in a multiethnic clinical trial of men with hypertension.
METHODS


We performed subgroup analyses from the Systolic Blood Pressure Intervention Trial ([SPRINT]; ClinicalTrials.gov: NCT120602, in a sample of 1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk. Participants were randomly assigned to an intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg).
MAIN OUTCOME MEASURE


The main outcome measure was change in erectile function from baseline, using the 5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21) after a median follow-up of 3 years.
RESULTS


At baseline, roughly two-thirds (66.1%) of the sample had self-reported ED. At 48 months after randomization, we determined that the effects of more intensive blood pressure lowering were significantly moderated by race-ethnicity (p for interaction = 0.0016), prompting separate analyses stratified by race-ethnicity. In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041). In non-Hispanic blacks, participants in the intensive group reported slightly worse change in the IIEF-5 score than those in the standard group (mean difference = -1.17; 95% CI = -1.92, -0.41; P = 0.0025). However, in non-Hispanic whites and non-Hispanic blacks, further adjustment for the baseline IIEF-5 score resulted in nonsignificant differences (P > 0.05) according to the treatment group. In Hispanic/other participants, there were no significant differences in change in the IIEF-5 score between the two treatment groups (P = 0.40). In a subgroup of 280 participants who did not report ED at baseline, the incidence of ED did not differ in the two treatment groups (P = 0.53) and was without interaction by race-ethnicity.
CLINICAL IMPLICATIONS


The effect of intensive treatment of blood pressure on erectile function was very small overall and likely not of great clinical magnitude.
STRENGTH & LIMITATIONS


Although this study included a validated measure of erectile function, testosterone, other androgen, and estrogen levels were not assessed.
CONCLUSION


In a sample of male patients at high risk for cardiovascular events but without diabetes, targeting a SBP of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in statistically significant effects on erectile function that differed in accordance with race-ethnicity, although the clinical importance of the differences may be of small magnitude. Foy CG, Newman JC, Russell GB, et al. Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial. J Sex Med 2020;17:238-248.",2020,"In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041).","['men with hypertension, but without diabetes', 'men with hypertension', '1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk', 'Hypertensive Men']","['Intensive vs Standard Blood Pressure Treatment', 'intensive blood pressure control', 'intensive systolic blood pressure (SBP) lowering', 'intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg']","['erectile function', 'erectile function, testosterone, other androgen, and estrogen levels', '5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21', 'change in erectile function', 'incidence of ED', 'intensive blood pressure lowering', 'IIEF-5 score', 'cardiovascular events']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",1255.0,0.183276,"In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041).","[{'ForeName': 'Capri G', 'Initials': 'CG', 'LastName': 'Foy', 'Affiliation': 'Division of Public Health Sciences, Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address: cfoy@wakehealth.edu.'}, {'ForeName': 'Jill C', 'Initials': 'JC', 'LastName': 'Newman', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistic and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Greg B', 'Initials': 'GB', 'LastName': 'Russell', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistic and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford VA Hospital, Bedford, MA, and Boston University School of Medicine and Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': ""Michael E. DeBakey Veterans' Administration Medical Center, Houston, TX, USA.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Burgner', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Thaddeus Y', 'Initials': 'TY', 'LastName': 'Carson', 'Affiliation': 'Division of Internal Medicine, Department of Medicine, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Doumas', 'Affiliation': 'Second Propedeutic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Robin Y', 'Initials': 'RY', 'LastName': 'Hughes', 'Affiliation': 'University Hospitals Case Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kostis', 'Affiliation': 'Robert Wood Johnson Medical School, Rutgers University, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ, USA.'}, {'ForeName': 'Peter van', 'Initials': 'PV', 'LastName': 'Buren', 'Affiliation': ""Department of Internal Medicine, Dallas Veterans' Administration Medical Center and University of Texas Southwestern Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Wadley', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.11.256']
822,31601539,"Update from TASCI, a Nationwide, Randomized, Sham-controlled, Double-blind Clinical Trial on Transcutaneous Tibial Nerve Stimulation in Patients with Acute Spinal Cord Injury to Prevent Neurogenic Detrusor Overactivity.","Transcutaneous tibial nerve stimulation has the potential to revolutionize the management of lower urinary tract dysfunction in patients with acute spinal cord injury. TASCI is a nationwide randomized, sham-controlled, double-blind clinical trial for which the preparatory phase has been successfully completed.",2020,Transcutaneous tibial nerve stimulation has the potential to revolutionize the management of lower urinary tract dysfunction in patients with acute spinal cord injury.,"['patients with acute spinal cord injury', 'Patients with Acute Spinal Cord Injury to Prevent Neurogenic Detrusor Overactivity']","['Transcutaneous Tibial Nerve Stimulation', 'Transcutaneous tibial nerve stimulation', 'TASCI']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1536696', 'cui_str': 'Overactivity'}]","[{'cui': 'C0040186', 'cui_str': 'Tibial Nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",[],,0.372834,Transcutaneous tibial nerve stimulation has the potential to revolutionize the management of lower urinary tract dysfunction in patients with acute spinal cord injury.,"[{'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'van der Lely', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Stalder', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Collene E', 'Initials': 'CE', 'LastName': 'Anderson', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland; Department of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland; Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Birkhäuser', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Bachmann', 'Affiliation': 'Medignition Inc. Research Consultants, Zürich, Switzerland.'}, {'ForeName': 'Martin W G', 'Initials': 'MWG', 'LastName': 'Brinkhof', 'Affiliation': 'Department of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland; Swiss Paraplegic Research, Nottwil, Switzerland.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Curt', 'Affiliation': 'Neurology, Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Jordan', 'Affiliation': 'Clinique Romande de Réadaptation, Sion, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Leitner', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Möhr', 'Affiliation': 'Neuro-Urology, REHAB Basel, Basel, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Pannek', 'Affiliation': 'Neuro-Urology, Swiss Paraplegic Center, Nottwil, Switzerland; Department of Urology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schubert', 'Affiliation': 'Neurology, Spinal Cord Injury Center, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland. Electronic address: tkessler@gmx.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology focus,['10.1016/j.euf.2019.09.019']
823,29316336,Enhancing interactions during daily routines: A randomized controlled trial of a web-based tutorial for parents of young children with ASD.,"Children with Autism Spectrum Disorder (ASD) often experience difficulty participating in everyday home routines, such as bed time or bath time. This randomized controlled trial examined the efficacy of an interactive, web-based parenting tutorial for improving children's engagement in daily routines (i.e., proximal outcomes) as well improving children's social communication and parenting efficacy and stress (i.e., broad outcomes). Parents of children with ASD between 18 and 60 months were randomly assigned to the Tutorial group (n = 52) or the Control group (n = 52). All parents completed questionnaires at baseline (T1), 1 month after T1 (T2; post-tutorial completion), and 2 months after T1 (T3). Relative to the Control group, parents in the Tutorial group reported significantly higher use of evidence-based instructional strategies and higher levels of child engagement during routines at T2 and T3. In addition, parents in the Tutorial group reported significantly lower parenting stress and higher parenting efficacy at T3, as well as higher ratings of child social communication at T2 and T3, compared to the Control group. Parents reported being highly satisfied with both the clinical content and technical aspects of the tutorial. These improvements in both proximal and broad parent-child outcomes suggest that this tutorial may be a promising and accessible way for empowering some parents and improving parent-child interactions. Autism Res 2018, 11: 667-678. © 2018 International Society for Autism Research, Wiley Periodicals, Inc.
LAY SUMMARY


This web-based tutorial helped parents of children with ASD use proven strategies to improve their child's participation in daily routines at home. Parents who used the tutorial reported less parenting stress, felt better about their parenting skills, and reported better child social interactions compared to parents who did not use the tutorial. This tutorial may be especially helpful for families who have limited access to services, as it can be completed at home.",2018,"Parents who used the tutorial reported less parenting stress, felt better about their parenting skills, and reported better child social interactions compared to parents who did not use the tutorial.","['Children with Autism Spectrum Disorder (ASD', 'parents of young children with ASD', 'Parents of children with ASD between 18 and 60 months', 'Autism Res 2018, 11: 667-678']","['interactive, web-based parenting tutorial']","['child social interactions', 'higher ratings of child social communication', 'parenting stress, felt better about their parenting skills', 'parenting stress and higher parenting efficacy', ""children's social communication and parenting efficacy and stress""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}]",,0.0716009,"Parents who used the tutorial reported less parenting stress, felt better about their parenting skills, and reported better child social interactions compared to parents who did not use the tutorial.","[{'ForeName': 'Lisa V', 'Initials': 'LV', 'LastName': 'Ibañez', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kobak', 'Affiliation': 'Center for Psychological Consultation, Madison, Wisconsin.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Swanson', 'Affiliation': 'Vanderbilt Kennedy Center Treatment and Research Institute for Autism Spectrum Disorders, (TRIAD), Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wallace', 'Affiliation': 'Vanderbilt Kennedy Center Treatment and Research Institute for Autism Spectrum Disorders, (TRIAD), Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Warren', 'Affiliation': 'Vanderbilt Kennedy Center Treatment and Research Institute for Autism Spectrum Disorders, (TRIAD), Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Stone', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington.'}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.1919']
824,31615381,Particle Flow Profiles From the Airways Measured by PExA Differ in Lung Transplant Recipients Who Develop Primary Graft Dysfunction.,"OBJECTIVES


Primary graft dysfunction is a severe form of acute lung injury and a major cause of early morbidity and mortality encountered after lung transplant.We used a customized PExA 2.0 instrument (PExA, Gothenburg, Sweden) to measure particle flow in exhaled air during mechanical ventilation in the intensive care unit. Our objective was to discover whether patients who developed primary graft dysfunction had different particle flow patterns from the airways. We used volume-controlled ventilation and pressure-controlled ventilation to see whether changes in particle patterns could be observed in both mechanical ventilation settings.
MATERIALS AND METHODS


First, we investigated whether it was safe to use a customized PExA 2.0 in conjunction with mechanical ventilation. Next, 12 lung transplant patients were randomized to either daily volumecontrolled ventilation or pressure-controlled ventilation as the first mode of treatment until extubation.
RESULTS


In our study group, 6 patients did not develop primary graft dysfunction and 6 developed primary graft dysfunction. Patients with primary graft dysfunction underwent mechanical ventilation significantly longer; they also showed a stepwise increase in particle count from day 0 until extubation. We observed no adverse events related to the PExA 2.0 device.
CONCLUSIONS


This study suggests that the PExA 2.0 device is safe to use in conjunction with mechanical ventilation in the intensive care unit. Lung transplant patients who developed primary graft dysfunction showed a different particle profile from the airways before clinical signs of primary graft dysfunction developed. Online assessment of ventilation impact before presentation of tissue changes may allow realtime detection of primary graft dysfunction, thus preventing or reducing its effects.",2019,Patients with primary graft dysfunction underwent mechanical ventilation significantly longer; they also showed a stepwise increase in particle count from day 0 until extubation.,"['Lung transplant patients who developed primary graft dysfunction', 'Patients with primary graft dysfunction underwent', 'Lung Transplant Recipients Who Develop Primary Graft Dysfunction', '12 lung transplant patients']","['daily volumecontrolled ventilation or pressure-controlled ventilation', 'customized PExA 2.0 instrument (PExA, Gothenburg, Sweden) to measure particle flow in exhaled air during mechanical ventilation', 'mechanical ventilation', 'customized PExA 2.0 in conjunction with mechanical ventilation', 'volume-controlled ventilation and pressure-controlled ventilation']","['particle count', 'primary graft dysfunction']","[{'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948031', 'cui_str': 'Primary Graft Dysfunction'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation (procedure)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0225387', 'cui_str': 'Exhaled air (substance)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1320708', 'cui_str': 'Volume controlled ventilation'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0948031', 'cui_str': 'Primary Graft Dysfunction'}]",,0.0389188,Patients with primary graft dysfunction underwent mechanical ventilation significantly longer; they also showed a stepwise increase in particle count from day 0 until extubation.,"[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Broberg', 'Affiliation': 'From the Department of Cardiothoracic Anaesthesia and Intensive Care, Skane University Hospital, Lund University, Sweden.'}, {'ForeName': 'Snejana', 'Initials': 'S', 'LastName': 'Hyllén', 'Affiliation': ''}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Algotsson', 'Affiliation': ''}, {'ForeName': 'Darcy E', 'Initials': 'DE', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lindstedt', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2019.0187']
825,31608424,"Comparing the effects of anticipatory postural adjustments focused training and balance training on postural preparation, balance confidence and quality of life in elderly with history of a fall.","BACKGROUND


Impairment of postural adjustments in elderly is associated with decreased functional mobility, balance confidence and quality of life.
AIMS


We studied the effects of anticipatory postural adjustments focused training on postural preparation, balance confidence and quality of life of the elderly.
METHODS


It was a single-blind randomized controlled trial. The sample included 60 males with history of falling (at least once in the past 6 months). They were matched and randomly assigned into three groups: perturbation, balance, and no training. The electrical activity of the muscles was measured by electromyography. The Activities-specific Balance Confidence (ABC) scale and the SF-36 questionnaire were used to assess balance confidence and quality of life, respectively. Repeated-measures ANOVA was used for data analysis (significant level 0.05).
RESULTS


The type of training had significant interaction effect on muscle latency (F (2, 46)  ≥ 71.06, P ≤ 0.001, η 2  ≥ 0.75). Compared to the other two groups, perturbation training group showed significantly more improvement in ABC scale (F (2, 46)  = 14.94, P ≤ 0.000, η 2  ≥ 0.39). It also significantly showed more improvement than no training group in all areas of SF-36 questionnaire, except for mental health (F (2, 46)  ≥ 6.56, P ≤ 0.03, η 2  ≥ 0.22).
CONCLUSIONS


Our findings support the use of perturbation training, as it reduced the probability of falling (by decreasing muscle latency and increasing posture preparation), improved the balance confidence for daily activities, and improved the quality of life.",2020,"It also significantly showed more improvement than no training group in all areas of SF-36 questionnaire, except for mental health (F (2, 46)  ≥ ","['elderly with history of a fall', '60 males with history of falling (at least once in the past 6\xa0months']","['anticipatory postural adjustments focused training', 'anticipatory postural adjustments focused training and balance training']","['Activities-specific Balance Confidence (ABC) scale and the SF-36 questionnaire', 'balance confidence and quality of life', 'quality of life', 'electrical activity of the muscles', 'functional mobility, balance confidence and quality of life', 'balance confidence for daily activities', 'SF-36 questionnaire, except for mental health (F (2, 46) \u2009≥', 'postural preparation, balance confidence and quality of life of the elderly', 'postural preparation, balance confidence and quality of life', 'ABC scale', 'muscle latency']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C2733457', 'cui_str': 'ABC (activities-specific balance confidence) scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0034380'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0222045'}]",60.0,0.0254731,"It also significantly showed more improvement than no training group in all areas of SF-36 questionnaire, except for mental health (F (2, 46)  ≥ ","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Arghavani', 'Affiliation': 'Corrective Exercise and Sport Injuries, Faculty of Exercise Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Zolaktaf', 'Affiliation': 'Corrective Exercise and Sport Injuries, Faculty of Exercise Sciences, University of Isfahan, Isfahan, Iran. v.zolaktaf@spr.ui.ac.ir.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Lenjannejadian', 'Affiliation': 'Sport Biomechanics, Faculty of Exercise Sciences, University of Isfahan, Isfahan, Iran.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01358-5']
826,31628043,Health-related Quality of Life in the Phase III LUME-Colon 1 Study: Comparison and Interpretation of Results From EORTC QLQ-C30 Analyses.,"INTRODUCTION


We used European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) data from the LUME-Colon 1 study to illustrate different methods of statistical analysis for health-related quality of life (HRQoL), and compared the results.
PATIENTS AND METHODS


Patients were randomized 1:1 to receive nintedanib 200 mg twice daily plus best supportive care (n = 386) or matched placebo plus best supportive care (n = 382). Five methods (mean treatment difference averaged over time, using a mixed-effects growth curve model; mixed-effects models for repeated measurements (MMRM); time-to-deterioration (TTD); status change; and responder analysis) were used to analyze EORTC QLQ-C30 global health status (GHS)/QoL and scores from functional scales.
RESULTS


Overall, GHS/QoL and physical functioning deteriorated over time. Mean treatment difference slightly favored nintedanib over placebo for physical functioning (adjusted mean, 2.66; 95% confidence interval [CI], 0.97-4.34) and social functioning (adjusted mean, 2.62; 95% CI, 0.66-4.47). GHS/QoL was numerically better with nintedanib versus placebo (adjusted mean, 1.61; 95% CI, -0.004 to 3.27). MMRM analysis had similar results, with better physical functioning in the nintedanib group at all timepoints. There was no significant delay in GHS/QoL deterioration (10%) and physical functioning (16%) with nintedanib versus placebo (TTD analysis). Status change analysis showed a higher proportion of patients with markedly improved GHS/QoL and physical functioning in the nintedanib versus placebo groups. Responder analysis showed a similar, less pronounced pattern.
CONCLUSION


Analyses of EORTC QLQ-C30 data showed that HRQoL was not impaired by treatment with nintedanib versus placebo. Analysis and interpretation of HRQoL endpoints should consider symptom type and severity and course of disease.",2019,Analyses of EORTC QLQ-C30 data showed that HRQoL was not impaired by treatment with nintedanib versus placebo.,['Patients'],"['placebo', 'nintedanib 200 mg twice daily plus best supportive care (n\xa0= 386) or matched placebo plus best supportive care']","['Overall, GHS/QoL and physical functioning', 'GHS/QoL', 'physical functioning', 'social functioning', 'Health-related Quality of Life', 'EORTC QLQ-C30 global health status (GHS)/QoL and scores from functional scales', 'GHS/QoL and physical functioning', 'GHS/QoL deterioration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0222045'}]",386.0,0.226032,Analyses of EORTC QLQ-C30 data showed that HRQoL was not impaired by treatment with nintedanib versus placebo.,"[{'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, USC Norris Comprehensive Cancer Center, Los Angeles, CA. Electronic address: lenz@usc.edu.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Argiles', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Phase 1 Trial Unit and Medical Oncology Unit 1, Istituto Oncologico Veneto IRCCS, Padova, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Oncology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'Limón', 'Affiliation': 'Medical Oncology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Medical Oncology 1, Ospedale Policlinico San Martino IRCCS, Genova, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hastedt', 'Affiliation': 'TA CNS Retinopathies Emerging Areas, Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Peil', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Voss', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Ingolf', 'Initials': 'I', 'LastName': 'Griebsch', 'Affiliation': 'TA Oncology, Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Digestive Oncology, University Hospitals Leuven and KULeuven, Leuven, Belgium.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2019.08.005']
827,29243519,Changes in behavioral outcomes among children affected by HIV: Results of a randomized controlled trial in China.,"This study assessed the effects of a multilevel intervention on HIV-affected children's negative behaviors. A total of 536 children aged 6-18 years from 475 HIV-affected families in Anhui, China, participated in the randomized controlled trial. A significant overall intervention effect on reducing negative behaviors was observed at 18-month follow-up, and the effect remained at 24-month follow-up. The intervention showed greater effects for children aged 13-18 years than those aged 6-12 years. Study findings suggest that a multilevel intervention approach could be beneficial for reducing negative behavior in HIV-affected children. Age-specific programs should be considered to maximize the intervention effects.",2019,"A significant overall intervention effect on reducing negative behaviors was observed at 18-month follow-up, and the effect remained at 24-month follow-up.","[""HIV-affected children's negative behaviors"", 'HIV-affected children', '536 children aged 6-18\u2009years from 475 HIV-affected families in Anhui, China', 'children affected by HIV', 'children aged 13-18\u2009years than those aged 6-12\u2009years']",['multilevel intervention'],"['negative behavior', 'negative behaviors', 'behavioral outcomes']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",536.0,0.134172,"A significant overall intervention effect on reducing negative behaviors was observed at 18-month follow-up, and the effect remained at 24-month follow-up.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': '1 University of California, Los Angeles (UCLA), USA.'}, {'ForeName': 'Li-Jung', 'Initials': 'LJ', 'LastName': 'Liang', 'Affiliation': '1 University of California, Los Angeles (UCLA), USA.'}, {'ForeName': 'Chunqing', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': '1 University of California, Los Angeles (UCLA), USA.'}, {'ForeName': 'Chiao-Wen', 'Initials': 'CW', 'LastName': 'Lan', 'Affiliation': '1 University of California, Los Angeles (UCLA), USA.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': '2 Anhui Provincial Center for Woman and Child Health, China.'}, {'ForeName': 'Yongkang', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': '3 Anhui Provincial Center for Disease Control and Prevention, China.'}]",Journal of health psychology,['10.1177/1359105317746479']
828,31611624,Long-term results of all-trans retinoic acid and arsenic trioxide in non-high-risk acute promyelocytic leukemia: update of the APL0406 Italian-German randomized trial.,,2020,,['non-high-risk acute promyelocytic leukemia'],['trans retinoic acid and arsenic trioxide'],[],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}]","[{'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0052416', 'cui_str': 'arsenic trioxide'}]",[],,0.0553994,,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cicconi', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Platzbecker', 'Affiliation': 'Universitätsklinikum Leipzig, Leipzig, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Avvisati', 'Affiliation': 'Ematologia e Trapianto di cellule staminali, Università Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Paoloni', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Universitätsklinikum Carl Gustav Carus der Technischen Universität, Dresden, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Vignetti', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Fazi', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Felicetto', 'Initials': 'F', 'LastName': 'Ferrara', 'Affiliation': 'Dipartimento di Ematologia e Trapianto di Cellule Staminali, Ospedale Cardarelli, Napoli, Italy.'}, {'ForeName': 'Mariadomenica', 'Initials': 'M', 'LastName': 'Divona', 'Affiliation': 'Laboratorio di Oncoematologia, Policlinico Tor Vergata, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Albano', 'Affiliation': 'Dipartimento di Ematologia, Università di Bari, Bari, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Efficace', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sborgia', 'Affiliation': 'U.O. di Ematologia Clinica, Pescara, Italy.'}, {'ForeName': 'Eros', 'Initials': 'E', 'LastName': 'Di Bona', 'Affiliation': 'Dipartimento di Terapie cellulari ed Ematologia, Unità Operativa di Ematologia, Ospedale S. Bortolo, Vicenza, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Breccia', 'Affiliation': 'Dipartimento di Biotecnologie Cellulari ed Ematologia, Università La Sapienza, Rome, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Borlenghi', 'Affiliation': 'Dipartimento di Ematologia, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cairoli', 'Affiliation': 'Grande Ospedale Metropolitano Niguarda, SC Ematologia, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Melillo', 'Affiliation': 'Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'La Nasa', 'Affiliation': 'Centro Trapianti Midollo Osseo, Ospedale R. Binaghi, Università di Cagliari, Cagliari, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiedler', 'Affiliation': 'University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'Department of Oncology, Hematology, Immuno-Oncology and Rheumatology, University Hospital Bonn, CIO Bonn, Bonn, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'Helmut R', 'Initials': 'HR', 'LastName': 'Salih', 'Affiliation': 'University Hospital Tubingen, Tubingen, Germany.'}, {'ForeName': 'Ombretta', 'Initials': 'O', 'LastName': 'Annibali', 'Affiliation': 'Ematologia e Trapianto di cellule staminali, Università Campus Bio-Medico, Rome, Italy.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Wattad', 'Affiliation': 'Kliniken Essen Süd, Essen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lubbert', 'Affiliation': 'University Medical Center, Freiburg, Germany.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Brandts', 'Affiliation': 'Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hanel', 'Affiliation': 'Klinikum Chemnitz gGmbH, Chemnitz, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rollig', 'Affiliation': 'Universitätsklinikum Carl Gustav Carus der Technischen Universität, Dresden, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Asklepios Klinik St Georg Hamburg, Hamburg, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': 'Klinik für Innere Medizin I, Westpfalz-Klinikum, Kaiserslautern, Germany.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Frairia', 'Affiliation': 'Città della Salute e della Scienza, Hematology, Torino, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Fozza', 'Affiliation': 'University of Sassari, Sassari, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': ""Maria D'Arco"", 'Affiliation': 'U.O. Medicina Interna e Onco-Ematologica P.O. Umberto I, Nocera Inferiore, Nocera Inferiore, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Di Renzo', 'Affiliation': 'Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Cortelezzi', 'Affiliation': ""Foundation Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico and University of Milan, Milan, Italy.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fabbiano', 'Affiliation': 'Divisione di Ematologia e Unità di Trapianti di Midollo Osseo, Ospedale Riuniti Villa Sofia-Cervello, Palermo, Italy.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Dohner', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Dohner', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Mandelli', 'Affiliation': 'GIMEMA Data Center, Rome, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Voso', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy. voso@med.uniroma2.it.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': 'Universitätsklinikum Carl Gustav Carus der Technischen Universität, Dresden, Germany.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'NCT Trial Center, National Center for Tumor Diseases Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Lo-Coco', 'Affiliation': 'Department of Biomedicine and Prevention, University Tor Vergata, Rome, Italy.'}]",Leukemia,['10.1038/s41375-019-0589-3']
829,31606860,Comparing the influence of exercise intensity on brain-derived neurotrophic factor serum levels in people with Parkinson's disease: a pilot study.,"INTRODUCTION


Endogenous brain-derived neurotrophic factor (BDNF) is thought to be protective against the neurodegeneration seen in Parkinson's disease (PD), and is thought to increase during exercise. This has been proposed as a possible mechanism by which exercise improves outcomes for people with PD. We conducted a pilot study to investigate the role of exercise intensity on BDNF levels in people with PD.
METHODS


Participants of early- to mid-stage disease were recruited from a single PD service in north-east England, UK into two separate studies of exercise in PD, one involving moderate-intensity continuous training (MICT) and one involving high-intensity interval training (HIIT), both had control groups. In both the interventions, participants exercise three times per week for 12 weeks. Blood samples were taken for BDNF analysis at the start and end of the first session and the start and end of the final session, with corresponding samples taken in controls.
RESULTS


Data were available for 27 participants (13 intervention, 14 control) in the MICT intervention and 17 (9 intervention, 8 control) in the HIIT intervention. BDNF level did not rise significantly from the start to end of individual sessions. Across the 12 week period, they rose significantly in the HIIT intervention group, but not in controls or the MICT intervention group.
CONCLUSIONS


High-intensity interval training appears to have a greater impact on BDNF than MICT. Future work should directly compare exercise modalities and investigate the impact of BDNF levels on disease progression and quality of life.",2020,"Across the 12 week period, they rose significantly in the HIIT intervention group, but not in controls or the MICT intervention group.
","['Participants of early- to mid-stage disease were recruited from a single PD service in north-east England, UK into two separate studies of', ""people with Parkinson's disease"", 'people with PD', '27 participants (13 intervention, 14 control) in the MICT intervention and 17 (9 intervention, 8 control) in the HIIT intervention']","['exercise in PD, one involving moderate-intensity continuous training (MICT) and one involving high-intensity interval training (HIIT), both had control groups', 'exercise intensity on brain-derived neurotrophic factor serum levels', 'HIIT intervention', 'MICT intervention', 'High-intensity interval training']","['BDNF level', 'BDNF levels']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",27.0,0.031136,"Across the 12 week period, they rose significantly in the HIIT intervention group, but not in controls or the MICT intervention group.
","[{'ForeName': 'Ailish', 'Initials': 'A', 'LastName': ""O'Callaghan"", 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital, Rake Lane, North Shields, Tyne and Wear, NE29 8NH, UK.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Harvey', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital, Rake Lane, North Shields, Tyne and Wear, NE29 8NH, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Houghton', 'Affiliation': 'Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Gray', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital, Rake Lane, North Shields, Tyne and Wear, NE29 8NH, UK. wagray70@gmail.com.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Weston', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Lloyd L', 'Initials': 'LL', 'LastName': 'Oates', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital, Rake Lane, North Shields, Tyne and Wear, NE29 8NH, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Romano', 'Affiliation': 'Medical School, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Walker', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital, Rake Lane, North Shields, Tyne and Wear, NE29 8NH, UK.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01353-w']
830,29362795,Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial.,"Importance


Effective and efficient treatment is needed for posttraumatic stress disorder (PTSD) in active duty military personnel.
Objective


To examine the effects of massed prolonged exposure therapy (massed therapy), spaced prolonged exposure therapy (spaced therapy), present-centered therapy (PCT), and a minimal-contact control (MCC) on PTSD severity.
Design, Setting, and Participants


Randomized clinical trial conducted at Fort Hood, Texas, from January 2011 through July 2016 and enrolling 370 military personnel with PTSD who had returned from Iraq, Afghanistan, or both. Final follow-up was July 11, 2016.
Interventions


Prolonged exposure therapy, cognitive behavioral therapy involving exposure to trauma memories/reminders, administered as massed therapy (n = 110; 10 sessions over 2 weeks) or spaced therapy (n = 109; 10 sessions over 8 weeks); PCT, a non-trauma-focused therapy involving identifying/discussing daily stressors (n = 107; 10 sessions over 8 weeks); or MCC, telephone calls from therapists (n = 40; once weekly for 4 weeks).
Main Outcomes and Measures


Outcomes were assessed before and after treatment and at 2-week, 12-week, and 6-month follow-up. Primary outcome was interviewer-assessed PTSD symptom severity, measured by the PTSD Symptom Scale-Interview (PSS-I; range, 0-51; higher scores indicate greater PTSD severity; MCID, 3.18), used to assess efficacy of massed therapy at 2 weeks posttreatment vs MCC at week 4; noninferiority of massed therapy vs spaced therapy at 2 weeks and 12 weeks posttreatment (noninferiority margin, 50% [2.3 points on PSS-I, with 1-sided α = .05]); and efficacy of spaced therapy vs PCT at posttreatment.
Results


Among 370 randomized participants, data were analyzed for 366 (mean age, 32.7 [SD, 7.3] years; 44 women [12.0%]; mean baseline PSS-I score, 25.49 [6.36]), and 216 (59.0%) completed the study. At 2 weeks posttreatment, mean PSS-I score was 17.62 (mean decrease from baseline, 7.13) for massed therapy and 21.41 (mean decrease, 3.43) for MCC (difference in decrease, 3.70 [95% CI,0.72 to 6.68]; P = .02). At 2 weeks posttreatment, mean PSS-I score was 18.03 for spaced therapy (decrease, 7.29; difference in means vs massed therapy, 0.79 [1-sided 95% CI, -∞ to 2.29; P = .049 for noninferiority]) and at 12 weeks posttreatment was 18.88 for massed therapy (decrease, 6.32) and 18.34 for spaced therapy (decrease, 6.97; difference, 0.55 [1-sided 95% CI, -∞ to 2.05; P = .03 for noninferiority]). At posttreatment, PSS-I scores for PCT were 18.65 (decrease, 7.31; difference in decrease vs spaced therapy, 0.10 [95% CI, -2.48 to 2.27]; P = .93).
Conclusions and Relevance


Among active duty military personnel with PTSD, massed therapy (10 sessions over 2 weeks) reduced PTSD symptom severity more than MCC at 2-week follow-up and was noninferior to spaced therapy (10 sessions over 8 weeks), and there was no significant difference between spaced therapy and PCT. The reductions in PTSD symptom severity with all treatments were relatively modest, suggesting that further research is needed to determine the clinical importance of these findings.
Trial Registration


clinicaltrials.gov Identifier: NCT01049516.",2018,"At posttreatment, PSS-I scores for PCT were 18.65 (decrease, 7.31; difference in decrease vs spaced therapy, 0.10 [95% CI, -2.48 to 2.27];","['Fort Hood, Texas, from January 2011 through July 2016 and enrolling 370 military personnel with PTSD who had returned from Iraq, Afghanistan, or both', '366 (mean age, 32.7 [SD, 7.3] years; 44 women [12.0%]; mean baseline PSS-I score, 25.49 [6.36]), and 216 (59.0%) completed the study', '370 randomized participants', 'in Military Personnel']","['Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy', 'Interventions\n\n\nProlonged exposure therapy, cognitive behavioral therapy involving exposure to trauma memories/reminders, administered as massed therapy (n\u2009=\u2009110; 10 sessions over 2 weeks) or spaced therapy', 'massed prolonged exposure therapy (massed therapy), spaced prolonged exposure therapy (spaced therapy), present-centered therapy (PCT), and a minimal-contact control (MCC', 'PCT, a non-trauma-focused therapy involving identifying/discussing daily stressors (n\u2009=\u2009107; 10 sessions over 8 weeks); or MCC, telephone calls from therapists (n\u2009=\u200940; once weekly for 4 weeks']","['PTSD symptom severity', 'PTSD Symptom Severity', 'PSS-I scores for PCT', 'efficacy of massed therapy', 'interviewer-assessed PTSD symptom severity, measured by the PTSD Symptom Scale-Interview', 'mean PSS-I score']","[{'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",370.0,0.0918616,"At posttreatment, PSS-I scores for PCT were 18.65 (decrease, 7.31; difference in decrease vs spaced therapy, 0.10 [95% CI, -2.48 to 2.27];","[{'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, Texas.'}, {'ForeName': 'Elna', 'Initials': 'E', 'LastName': 'Yadin', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Yarvis', 'Affiliation': 'Headquarters, Carl R. Darnall Army Medical Center, Fort Hood, Texas.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Elisa V', 'Initials': 'EV', 'LastName': 'Borah', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Fina', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Hall-Clark', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Lichner', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiological Research and Information Center, VA Boston Healthcare System, Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Texas Health Science Center at San Antonio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2017.21242']
831,31613706,A Pilot and Feasibility Study of Oatmeal Consumption in Children to Assess Markers of Bowel Function.,"Inadequate dietary fiber intake contributes to irregular bowel movements and may contribute to difficulty with defecation in children. Whole grain foods, such as oatmeal, may improve stool consistency and stool frequency in children; however, no studies have examined its effects. The purpose of this study was to investigate if 2 weeks of oatmeal consumption in children (ages 7-12 years) increases stool frequency, improves stool consistency, and gastrointestinal (GI) symptoms. In this single-arm intervention study, children who reported ≤5 bowel movements per week during screening, consumed two servings of instant oatmeal daily for 2 weeks. The primary outcome was stool frequency and secondary outcomes included stool consistency and GI symptoms. Participants recorded bowel movements daily, food intake, and GI symptoms during baseline and 2 intervention weeks. Photos of the children's stool were taken at three timepoints during the study to assess stool consistency. In total, 33 children (15 female and 18 male) completed the study. Linear mixed models were used to detect change between baseline and the intervention weeks and accounted for repeated measures within subjects. No statistical differences in stool frequency or consistency were observed between the intervention weeks vs. baseline; however, dietary fiber intake significantly increased during the 2 weeks of oatmeal consumption ( P  = .008). The addition of oatmeal to children's diets is an effective way to increase fiber consumption and may reduce some GI symptoms such as gas, straining, and feeling of incomplete evacuation. Trial identification number: NCT02868515.",2020,"No statistical differences in stool frequency or consistency were observed between the intervention weeks vs. baseline; however, dietary fiber intake significantly increased during the 2 weeks of oatmeal consumption ( P  = .008).","['Children to Assess Markers of Bowel Function', 'children', '33 children (15 female and 18 male) completed the study', 'children (ages 7-12 years']",['Oatmeal Consumption'],"['stool consistency and stool frequency', 'stool frequency, improves stool consistency, and gastrointestinal (GI) symptoms', 'stool frequency or consistency', 'stool consistency and GI symptoms', 'dietary fiber intake', 'bowel movements daily, food intake, and GI symptoms', 'stool frequency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0452680', 'cui_str': 'Oatmeal (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake (observable entity)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",33.0,0.133884,"No statistical differences in stool frequency or consistency were observed between the intervention weeks vs. baseline; however, dietary fiber intake significantly increased during the 2 weeks of oatmeal consumption ( P  = .008).","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Paruzynski', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St. Paul, Minnesota, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korczak', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St. Paul, Minnesota, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Clinical and Translational Science Institute, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Slavin', 'Affiliation': 'Department of Food Science and Nutrition, University of Minnesota, St. Paul, Minnesota, USA.'}]",Journal of medicinal food,['10.1089/jmf.2019.0158']
832,31064779,FDA Approval Summary: Glasdegib for Newly Diagnosed Acute Myeloid Leukemia.,"On November 21, 2018, the FDA approved glasdegib (Daurismo; Pfizer), a small-molecule Hedgehog inhibitor, in combination with low-dose cytarabine (LDAC) for treatment of newly diagnosed acute myeloid leukemia (AML) in adults ≥ 75 years or with comorbidities that preclude use of intensive induction chemotherapy. Evidence of clinical benefit came from Study BRIGHT AML 1003, a randomized trial comparing glasdegib+LDAC with LDAC alone for treatment of newly diagnosed AML in 115 patients either ≥ 75 years old or ≥ 55 years old with preexisting comorbidities. Efficacy was established by improved overall survival (OS) with the combination compared with LDAC alone (HR, 0.46; 95% confidence interval, 0.30-0.71; one-sided stratified log-rank  P  = 0.0002). Median OS was 8.3 months with the combination and 4.3 months with LDAC alone. Common adverse reactions included cytopenias, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash. The label includes a boxed warning for embryo-fetal toxicity and a warning for QT interval prolongation. There is a limitation of use for patients with moderate-to-severe hepatic and severe renal impairment; trials studying glasdegib in these patient populations are required as a condition of this approval. See related commentary by Fathi, p. 6015 .",2019,"Efficacy was established by improved overall survival (OS) with the combination compared with LDAC alone (HR, 0.46; 95% confidence interval, 0.30-0.71; one-sided stratified log-rank  P  = 0.0002).","['patients with moderate-to-severe hepatic and severe renal impairment', '115 patients either ≥ 75 years old or ≥ 55 years old with preexisting comorbidities', 'newly diagnosed acute myeloid leukemia (AML) in adults ≥ 75 years or with comorbidities that preclude use of intensive induction chemotherapy', 'Newly Diagnosed Acute Myeloid Leukemia']","['cytarabine (LDAC', 'glasdegib+LDAC with LDAC', 'LDAC']","['cytopenias, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash', 'Median OS', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.081904,"Efficacy was established by improved overall survival (OS) with the combination compared with LDAC alone (HR, 0.46; 95% confidence interval, 0.30-0.71; one-sided stratified log-rank  P  = 0.0002).","[{'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Norsworthy', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Kelly.Norsworthy@fda.hhs.gov.'}, {'ForeName': 'Kunthel', 'Initials': 'K', 'LastName': 'By', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Subramaniam', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Luning', 'Initials': 'L', 'LastName': 'Zhuang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Del Valle', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Przepiorka', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Yuan-Li', 'Initials': 'YL', 'LastName': 'Shen', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Sheth', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Leong', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Ann T', 'Initials': 'AT', 'LastName': 'Farrell', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0365']
833,29139311,Baseline sleep quality is a significant predictor of quit-day smoking self-efficacy among low-income treatment-seeking smokers.,"Compared to non-smokers, smokers have an increased risk for poor sleep quality, which could undermine confidence to quit. This study examined whether baseline sleep quality was associated with quit-day smoking self-efficacy among smokers enrolled in a smoking cessation trial. Treatment-seeking low-income smokers were randomized to either a low-intensity physical activity integrated with standard smoking cessation intervention or standard care cessation only. Poor sleep quality was significantly associated with lower quit-day (week 4) smoking self-efficacy ( β  = -0.61; standard error = 8.1;  p  = .03). Over half the samples (53%) reported poor sleep quality, thus addressing baseline sleep quality is an important consideration in smoking cessation programs.",2019,Treatment-seeking low-income smokers were randomized to either a low-intensity physical activity integrated with standard smoking cessation intervention or standard care cessation only.,"['Treatment-seeking low-income smokers', 'smokers enrolled in a smoking cessation trial']",['low-intensity physical activity integrated with standard smoking cessation intervention or standard care cessation only'],"['baseline sleep quality', 'Baseline sleep quality', 'quit-day smoking self-efficacy', 'poor sleep quality', 'Poor sleep quality']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}]",,0.00906873,Treatment-seeking low-income smokers were randomized to either a low-intensity physical activity integrated with standard smoking cessation intervention or standard care cessation only.,"[{'ForeName': 'Uma S', 'Initials': 'US', 'LastName': 'Nair', 'Affiliation': '1 Department of Health Promotion Sciences, The University of Arizona, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Haynes', 'Affiliation': '1 Department of Health Promotion Sciences, The University of Arizona, USA.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': '2 College of Public Health, Temple University, USA.'}]",Journal of health psychology,['10.1177/1359105317740619']
834,29060358,Pressure ulcer risk detection from complexity of activity.,"Activity levels in nursing home residents were measured with accelerometers over one week as part of a multicenter randomized controlled trial, and complexity of the resulting activity patterns were characterized. Among 813 study participants on whom activity data had been collected, 16 participants developed pressure ulcers by the end of the study. The fractal dimension D 0  of the activity series was lower (p=0.039) in residents who developed pressure ulcers than in controls matched on the basis of race, randomization group, score on the Braden scale, and diagnoses of cardiovascular disease and dementia. Hurst exponents indicated that the scaling of the power spectrum was close to 1/f in pressure ulcer cases. At timescales exceeding 30 minutes, approximate entropy tended to be higher in the controls than in the pressure ulcer cases. The fractal structure of the activity time series and its information content offer the ability to predict higher risk of development of pressure ulcers in nursing home residents.",2017,"The fractal dimension D 0  of the activity series was lower (p=0.039) in residents who developed pressure ulcers than in controls matched on the basis of race, randomization group, score on the Braden scale, and diagnoses of cardiovascular disease and dementia.","['813 study participants on whom activity data had been collected, 16 participants developed pressure ulcers by the end of the study', 'nursing home residents']",[],"['Activity levels', 'pressure ulcers', 'fractal dimension D 0  of the activity series']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]",[],"[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C0206163', 'cui_str': 'Fractals'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}]",813.0,0.0149156,"The fractal dimension D 0  of the activity series was lower (p=0.039) in residents who developed pressure ulcers than in controls matched on the basis of race, randomization group, score on the Braden scale, and diagnoses of cardiovascular disease and dementia.","[{'ForeName': 'Nikhil S', 'Initials': 'NS', 'LastName': 'Padhye', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bergstrom', 'Affiliation': ''}, {'ForeName': 'Mary Pat', 'Initials': 'MP', 'LastName': 'Rapp', 'Affiliation': ''}, {'ForeName': 'LuAnn', 'Initials': 'L', 'LastName': 'Etcher', 'Affiliation': ''}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Redeker', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2017.8037316']
835,29060413,Influence of light finger touch on postural stability during upright stance with cold-induced plantar hypoesthesia.,"The present study investigated the influence of light finger touch on postural stability during an upright stance with or without cold-induced plantar hypoesthesia. Participants were 21 healthy right-handed men (20-33 years), randomly assigned to a normal temperature group (NML-group; n = 11) or cold-induced plantar hypoesthesia group (COLD-group; n = 10). Participants performed two standing tasks with their eyes closed: 1) stand upright with the feet comfortably apart (normal standing); and 2) with the feet together in a side-by-side stance (Romberg standing). The order of the tasks was randomized across participants. After a rest period, they were asked to perform each standing task and let their right index finger lightly touch the fixed surface. Before the each task, participants in the COLD group were conducted a plantar intermediate hypothermic exposure. Postural sway was decreased by providing additional haptic sensory input through the light touching regardless of standing task difficulty with a normal plantar temperature. Although postural sway under plantar hypoesthesia is decreased by light touching, the effect was greater during the difficult posture task. These results suggest that, when the sensory information from the plantar surface is decreased, additional haptic input from the hand or finger might provide supplementary information about the relative changes in one's own body orientation. Therefore, sensory information provided by touching became relatively more important to maintaining postural control during the relatively difficult postural task performed under the reduced plantar sensitivity condition.",2017,Postural sway was decreased by providing additional haptic sensory input through the light touching regardless of standing task difficulty with a normal plantar temperature.,"['Participants were 21 healthy right-handed men (20-33 years', 'upright stance with cold-induced plantar hypoesthesia']","['normal temperature group (NML-group; n = 11) or cold-induced plantar hypoesthesia group (COLD-group; n = 10', 'standing tasks with their eyes closed: 1) stand upright with the feet comfortably apart (normal standing); and 2) with the feet together in a side-by-side stance (Romberg standing', 'light finger touch', 'upright stance with or without cold-induced plantar hypoesthesia']","['Postural sway', 'postural sway under plantar hypoesthesia', 'postural stability']","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}]",21.0,0.0214706,Postural sway was decreased by providing additional haptic sensory input through the light touching regardless of standing task difficulty with a normal plantar temperature.,"[{'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Oshita', 'Affiliation': ''}, {'ForeName': 'Sumio', 'Initials': 'S', 'LastName': 'Yano', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2017.8037371']
836,29060739,Feasibility of using the RAPAEL Smart Glove in upper limb physical therapy for patients after stroke: A randomized controlled trial.,We aim to assess the feasibility of using the RAPAEL Smart Glove as an assistive tool for therapists in clinical rehabilitation therapy settings and to investigate if it can be used to improve the motor recovery rate of stroke survivors. Our randomized controlled study involved 13 post-stroke inpatients. An experimental treatment consisted of one 30-minute game-assisted therapy and one 30-minute conventional therapy per day while the control treatment consisted of two 30-minute conventional therapies. Each therapy block consisted of 15 days over a period of 3 weeks. The measured outcomes were the scores on the Wolf Motor Function Test and the active range of motion for the forearm and the wrist. The mean Wolf Motor Function Test score for the group that received game therapies as well as conventional therapies was significantly higher than that for the group who received only conventional therapies. The results suggest that the motor recovery rate of the clinical rehabilitation therapies can be improved when wearable sensors and therapeutic games are used by therapists in their routine therapy practice.,2017,The mean Wolf Motor Function Test score for the group that received game therapies as well as conventional therapies was significantly higher than that for the group who received only conventional therapies.,"['patients after stroke', '13 post-stroke inpatients']",['RAPAEL Smart Glove'],"['Wolf Motor Function Test and the active range of motion for the forearm and the wrist', 'mean Wolf Motor Function Test score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C0206069', 'cui_str': 'Glove'}]","[{'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",13.0,0.0411523,The mean Wolf Motor Function Test score for the group that received game therapies as well as conventional therapies was significantly higher than that for the group who received only conventional therapies.,"[{'ForeName': '', 'Initials': '', 'LastName': 'Hee-Tae Jung', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Hwan Kim', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Jugyeong Jeong', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Bomin Jeon', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Taekeong Ryu', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Yangsoo Kim', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2017.8037698']
837,29060810,Self-regulation of primary motor cortex activity with motor imagery induces functional connectivity modulation: A real-time fMRI neurofeedback study.,"Recent developments in data acquisition of functional magnetic resonance imaging (fMRI) have led to rapid preprocessing and analysis of brain activity in a quasireal-time basis, what so called real-time fMRI neurofeedback (rtfMRI-NFB). This information is fed back to subjects allowing them to gain a voluntary control over their own region-specific brain activity. Forty-one healthy participants were randomized into an experimental (NFB) group, who received a feedback directly proportional to their brain activity from the primary motor cortex (M1), and a control (CTRL) group who received a sham feedback. The M1 ROI was functionally localized during motor execution and imagery tasks. A resting-state functional run was performed before and after the neurofeedback training to investigate the default mode network (DMN) modulation after training. The NFB group revealed increased DMN functional connectivity after training to the cortical and subcortical sensory/motor areas (M1/S1 and caudate nucleus, respectively), which may be associated with sensorimotor processing of learning in the resting state. These results show that motor imagery training through rtfMRI-NFB could modulate the DMN functional connectivity to motor-related areas, suggesting that this modulation potentially subserved the establishment of motor learning in the NFB group.",2017,"These results show that motor imagery training through rtfMRI-NFB could modulate the DMN functional connectivity to motor-related areas, suggesting that this modulation potentially subserved the establishment of motor learning in the NFB group.",['Forty-one healthy participants'],"['functional magnetic resonance imaging (fMRI', 'NFB', 'feedback directly proportional to their brain activity from the primary motor cortex (M1), and a control (CTRL) group who received a sham feedback']",['DMN functional connectivity'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",41.0,0.0295576,"These results show that motor imagery training through rtfMRI-NFB could modulate the DMN functional connectivity to motor-related areas, suggesting that this modulation potentially subserved the establishment of motor learning in the NFB group.","[{'ForeName': 'Meena M', 'Initials': 'MM', 'LastName': 'Makary', 'Affiliation': ''}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Seulgi', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Kyungmo Park', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2017.8037769']
838,29060853,The challenge of magnetic vagal nerve stimulation for myocardial infarction -preliminary clinical trial.,"Numerous studies have shown in animal models that vagal nerve stimulation (VNS) strikingly reduces infarct size of acute myocardial infarction (AMI) and prevents heart failure. However, the lack of techniques to noninvasively stimulate the vagal nerve hinders VNS from clinical applications. Transcranial magnetic stimulation is noninvasive and capable of stimulating central neurons in patients. In this study, we examined whether the magnetic stimulation could noninvasively activate the cervical vagal nerve in healthy human. Sixteen healthy males and 4 females were enrolled in this study. We used Magstim Rapid2 with a 70-mm double coil in the right neck. We randomly assigned the subjects to 5 Hz or 20 Hz stimulation. We defined the maximum intensity of stimulation (MAX) which is the intensity just below the threshold of adverse effects. We defined HALF as a half of MAX. Protocols comprised 2 sets of MAX and 2 sets of HALF. Each stimulation continued for 3 minutes. We monitored heart rate (HR) and assessed the bradycardic response as an index of successful VNS. Nineteen subjects completed all protocols. They had no problematic adverse events during and/or after magnetic VNS. The magnetic VNS induced transient bradycardic responses in some subjects, whereas failed to induce sustained bradycardia in pooled data in any settings. Arterial pressure did not change either. Successful magnetic stimulation requires technical improvements including narrowing the magnetic focus and optimization of stimulation site. These improvements may enable us to apply magnetic VNS in the management of AMI.",2017,"The magnetic VNS induced transient bradycardic responses in some subjects, whereas failed to induce sustained bradycardia in pooled data in any settings.","['Sixteen healthy males and 4 females', 'Nineteen subjects completed all protocols', 'healthy human', 'patients']","['Transcranial magnetic stimulation', 'magnetic vagal nerve stimulation', 'magnetic stimulation']","['transient bradycardic responses', 'Arterial pressure', 'heart rate (HR', 'maximum intensity of stimulation (MAX', 'infarct size of acute myocardial infarction (AMI) and prevents heart failure', 'bradycardic response']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",16.0,0.0471484,"The magnetic VNS induced transient bradycardic responses in some subjects, whereas failed to induce sustained bradycardia in pooled data in any settings.","[{'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Nishikawa', 'Affiliation': ''}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Saku', 'Affiliation': ''}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Todaka', 'Affiliation': ''}, {'ForeName': 'Yukimitsu', 'Initials': 'Y', 'LastName': 'Kuwabara', 'Affiliation': ''}, {'ForeName': 'Shinobu', 'Initials': 'S', 'LastName': 'Arai', 'Affiliation': ''}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Kishi', 'Affiliation': ''}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Ide', 'Affiliation': ''}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsutsui', 'Affiliation': ''}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sunagawa', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2017.8037812']
839,31524123,The effects of supplementing maternal and infant diets with lipid-based nutrient supplements on physical activity and sedentary behaviour at preschool age in Ghana.,"Evidence on whether nutritional supplementation affects physical activity (PA) during early childhood is limited. We examined the long-term effects of lipid-based nutrient supplements (LNS) on total PA, moderate-to-vigorous PA (MVPA) and sedentary behaviour (SB) of children at 4-6 years using an accelerometer for 1 week. Their mothers were enrolled in the International Lipid-based Nutrient Supplement-DYAD randomised controlled trial in Ghana, assigned to daily LNS or multiple micronutrients (MMN) during pregnancy through 6 months postpartum or Fe and folic acid (IFA) during pregnancy and placebo for 6 months postpartum. From 6 to 18 months, children in the LNS group received LNS; the other two groups received no supplements. Analysis was done with intention to treat comparing two groups: LNS v. non-LNS (MMN+ IFA). Of the sub-sample of 375 children fitted with accelerometers, 353 provided sufficient data. Median vector magnitude (VM) count was 1374 (interquartile range (IQR) 309), and percentages of time in MVPA and SB were 4·8 (IQR 2) and 31 (IQR 8) %, respectively. The LNS group (n 129) had lower VM (difference in mean -73 (95 % CI -20, -126), P = 0·007) and spent more time in SB (LNS v. non-LNS: 32·3 v. 30·5 %, P = 0·020) than the non-LNS group (n 224) but did not differ in MVPA (4·4 v. 4·7 %, P = 0·198). Contrary to expectations, provision of LNS in early life slightly reduced the total PA and increased the time in SB but did not affect time in MVPA. Given reduced social-emotional difficulties in the LNS group previously reported, including hyperactivity, one possible explanation is less restless movement in the LNS group.",2019,The LNS group (n 129) had lower VM (difference in mean -73,"['children at 4-6\xa0years using an accelerometer for 1\xa0week', '375 children fitted with accelerometers, 353 provided sufficient data', 'at preschool age in Ghana']","['LNS', 'LNS v. non-LNS (MMN+ IFA', 'lipid-based nutrient supplements (LNS', 'nutritional supplementation', 'supplementing maternal and infant diets with lipid-based nutrient supplements', 'LNS or multiple micronutrients (MMN) during pregnancy through 6 months postpartum or Fe and folic acid (IFA) during pregnancy and placebo']","['total PA, moderate-to-vigorous PA (MVPA) and sedentary behaviour (SB', 'physical activity and sedentary behaviour', 'percentages of time in MVPA and SB', 'social-emotional difficulties', 'physical activity (PA', 'spent more time in SB', 'Median vector magnitude (VM) count', 'time in SB', 'lower VM', 'total PA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]","[{'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0311143', 'cui_str': 'Infant diet'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",375.0,0.148214,The LNS group (n 129) had lower VM (difference in mean -73,"[{'ForeName': 'Maku E', 'Initials': 'ME', 'LastName': 'Ocansey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pulakka', 'Affiliation': 'Department of Public Health, University of Turku and Turku University Hospital, 20014 Turku, Finland.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Adu-Afarwuah', 'Affiliation': 'Department of Nutrition and Food Science, University of Ghana, Legon 20520, Ghana.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Young', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Sika M', 'Initials': 'SM', 'LastName': 'Kumordzie', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Okronipa', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Brietta M', 'Initials': 'BM', 'LastName': 'Oaks', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Program in International and Community Nutrition, Department of Nutrition, University of California, Davis, CA 95616, USA.'}]",The British journal of nutrition,['10.1017/S0007114519001636']
840,31599995,Effectiveness of a multicomponent intervention to reduce social isolation and loneliness in community-dwelling elders: A randomized clinical trial. Study protocol.,"AIMS


This study aims to evaluate the effectiveness of a multicomponent intervention in non-institutionalized older people. This effectiveness will be assessed in terms of reducing social isolation and loneliness and improving Health-Related Quality of Life.
BACKGROUND


The concern for social isolation and loneliness in non-institutionalized older adults has increased in recent decades. In addition, their relationship with numerous negative health outcomes is amply demonstrated.
DESIGN


A mixed-method design including a cluster randomized controlled clinical trial and an exploratory qualitative study with focus groups was used.
METHOD


Each study group consists of 57 subjects. The experimental group will be subjected to a multicomponent intervention comprising six domiciliary face-to-face sessions and five telephone calls that will be interspersed. Interventions will be conducted by healthcare professionals and volunteers. The control group will not be subjected to any systematized intervention. We are going to consider social isolation, loneliness, and Quality of Life as the primary outcomes. However, the factors that influence both primary outcomes and the feasibility of the intervention in clinical practice will also be assessed.
DISCUSSION


Despite the negative influence of social isolation and loneliness on clinical outcomes is widely evidenced, few early detection programs are available, especially interventions at the community setting. This study will examine the effectiveness of the intervention in the Spanish community setting. At the same time, this study will identify the feasibility of this intervention in Primary Care clinical practice.
IMPACT


Substantial evidence indicates the detrimental health impact of social isolation and loneliness, particularly on mental wellness. Knowing that mental disorders are associated with high economic cost, this project would have strong clinical implication to inform nursing practice on managing social isolation and loneliness. The findings may also inform primary health policy setting in Spain and the wider European countries.",2020,The control group will not be subjected to any systematized intervention.,"['non-institutionalized older people', 'non-institutionalized older adults', '57 subjects', 'community-dwelling elders']",['multicomponent intervention'],"['social isolation and loneliness', 'social isolation and loneliness and improving Health-Related Quality of Life']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]",[],"[{'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0023974', 'cui_str': 'Loneliness'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",57.0,0.0446677,The control group will not be subjected to any systematized intervention.,"[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Hernández-Ascanio', 'Affiliation': 'CIBER de Fragilidad y Envejecimiento Saludable (CIBERFES), Madrid, Spain.'}, {'ForeName': 'Luis Ángel', 'Initials': 'LÁ', 'LastName': 'Pérula-de Torres', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba, Hospital Universitario Reina Sofía, Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Roldán-Villalobos', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba, Hospital Universitario Reina Sofía, Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Pérula-de Torres', 'Affiliation': 'Instituto Maimónides de Investigación Biomédica de Córdoba, Hospital Universitario Reina Sofía, Universidad de Córdoba, Córdoba, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rich-Ruiz', 'Affiliation': 'CIBER de Fragilidad y Envejecimiento Saludable (CIBERFES), Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of advanced nursing,['10.1111/jan.14230']
841,31847536,Improved clinical outcomes among persons with HIV who quit smoking.,"Quitting smoking among people living with HIV/AIDS (PLWHA) is a priority. However, PLWHA and clinicians working with PLWHA are reluctant to use tobacco use treatments out of concern that smoking cessation can diminish anti-retroviral therapy (ART) adherence and quality of life (QoL) and increase psychiatric symptoms. This secondary analysis from a placebo-controlled varenicline trial for tobacco dependence among PLWHA ( N  = 179) examined if smoking cessation at the end of treatment (EOT) was associated with changes in ART adherence, QoL, anxiety and depression symptoms, and varenicline side effects. ART adherence was not affected by smoking cessation ( p  > 0.05), remaining ≥98% for all participants. Across 8 QoL subscales, 7 remained unchanged over time across smokers and abstainers; side effects were not associated with cessation. Controlling for baseline smoking rate, adherence to varenicline/placebo and counseling, and treatment arm, participants who had quit smoking at EOT reported a significant reduction in depression ( β  = -1.657, 95% CI: -2.893, -0.422,  p  = .009) and anxiety ( β  = -1.434, 95% CI: -2.812, -0.56,  p  = .041) and increased life satisfaction ( β  = 0.88, 95% CI: 0.21, 3.275,  p  = .027). When PLWHA quit smoking they may not experience adverse clinical outcomes including ART non-adherence and may experience beneficial psychological effects, supporting the use of FDA-approved smoking cessation treatments among PLWHA.",2020,"ART adherence was not affected by smoking cessation ( p  > 0.05), remaining ≥98% for all participants.","['persons with HIV who quit smoking', 'people living with HIV/AIDS (PLWHA']","['placebo-controlled varenicline', 'varenicline/placebo']","['anti-retroviral therapy (ART) adherence and quality of life (QoL) and increase psychiatric symptoms', 'life satisfaction', 'Quitting smoking', 'anxiety', 'ART adherence, QoL, anxiety and depression symptoms, and varenicline side effects', 'depression', 'ART adherence']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034380'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",8.0,0.131834,"ART adherence was not affected by smoking cessation ( p  > 0.05), remaining ≥98% for all participants.","[{'ForeName': 'Su Fen', 'Initials': 'SF', 'LastName': 'Lubitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'Pulmonary, Allergy, & Critical Care Division, University of Pennsylvania Presbyterian Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Division of Infectious Diseases, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}]",AIDS care,['10.1080/09540121.2019.1703891']
842,28268330,Effect of self-monitoring clusters on weight and hemoglobin A1c.,"We investigated whether participants with higher adherence to smartphone or paper-based self-monitoring of diet, physical activity, blood glucose, and body weight have a beneficial impact on their body weight and hemoglobin A1c measures over a 3-month period. Data were combined from two intervention studies that recruited overweight or obese participants with type 2 diabetes. Three clusters of adherence to self-monitoring were identified. Participants in a cluster with high adherence to self-monitoring of diet and moderate adherence to glucose self-monitoring were found to have the biggest reductions in weight and hemoglobin A1c, as compared to clusters with either high or low adherence to self-monitoring of all four factors.",2016,"We investigated whether participants with higher adherence to smartphone or paper-based self-monitoring of diet, physical activity, blood glucose, and body weight have a beneficial impact on their body weight and hemoglobin A1c measures over a 3-month period.","['participants with higher adherence to smartphone or paper-based self-monitoring of diet', 'recruited overweight or obese participants with type 2 diabetes']",['self-monitoring clusters'],['weight and hemoglobin A1c'],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",,0.0107979,"We investigated whether participants with higher adherence to smartphone or paper-based self-monitoring of diet, physical activity, blood glucose, and body weight have a beneficial impact on their body weight and hemoglobin A1c measures over a 3-month period.","[{'ForeName': 'Nikhil S', 'Initials': 'NS', 'LastName': 'Padhye', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Jing Wang', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2016.7590693']
843,28268619,An audiovisual BCI system for assisting clinical communication assessment in patients with disorders of consciousness: a case study.,"The JFK Coma Recovery Scale-Revised (JFK CRS-R), a behavioral scale, is often used for clinical assessments of patients with disorders of consciousness (DOC), such as patients in a vegetative state. However, there has been a high rate of clinical misdiagnosis with the JFK CRS-R because patients with severe brain injures cannot provide sufficient behavioral responses. It is particularly difficult to evaluate the communication function in DOC patients using the JFK CRS-R because a higher level of behavioral responses is needed for communication assessments than for many other assessments, such as an auditory startle assessment. Brain-computer interfaces (BCIs), which provide control and communication by detecting changes in brain signals, can be used to evaluate patients with DOC without the need of behavioral expressions. In this paper, we proposed an audiovisual BCI system to supplement the JFK CRS-R in assessing the communication ability of patients with DOC. In the graphic user interface of the BCI system, two word buttons (""Yes"" and ""No"" in Chinese) were randomly displayed in the left and right sides and flashed in an alternating manner. When a word button flashed, its corresponding spoken word was broadcast from an ipsilateral headphone. The use of semantically congruent audiovisual stimuli improves the detection performance of the BCI system. Similar to the JFK CRS-R, several situation-orientation questions were presented one by one to patients with DOC. For each question, the patient was required to provide his/her answer by selectively focusing on an audiovisual stimulus (audiovisual ""Yes"" or ""No""). As a case study, we applied our BCI system in a patient with DOC who was clinically diagnosed as being in a minimally conscious state (MCS). According to the JFK CRS-R assessment, this patient was unable to communicate consistently. However, he achieved a high accuracy of 86.5% in our BCI experiment. This result indicates his reliable communication ability and demonstrates the effectiveness of our system.",2016,"The JFK Coma Recovery Scale-Revised (JFK CRS-R), a behavioral scale, is often used for clinical assessments of patients with disorders of consciousness (DOC), such as patients in a vegetative state.","['patient with DOC who was clinically diagnosed as being in a minimally conscious state (MCS', 'patients with disorders of consciousness', 'patients with disorders of consciousness (DOC', 'patients with DOC']","['Brain-computer interfaces (BCIs', 'audiovisual BCI system', 'semantically congruent audiovisual stimuli']",['JFK Coma Recovery Scale-Revised (JFK CRS-R'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011710', 'cui_str': 'desoxycortone'}, {'cui': 'C0751699', 'cui_str': 'Minimally Conscious State'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]","[{'cui': 'C3494288', 'cui_str': 'Brain-Computer Interfaces'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439853', 'cui_str': 'Congruent (qualifier value)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]","[{'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0222045'}]",,0.0171264,"The JFK Coma Recovery Scale-Revised (JFK CRS-R), a behavioral scale, is often used for clinical assessments of patients with disorders of consciousness (DOC), such as patients in a vegetative state.","[{'ForeName': '', 'Initials': '', 'LastName': 'Fei Wang', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Yanbin He', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Jun Qu', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Qiuyou Xie', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Qing Lin', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Xiaoxiao Ni', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Yan Chen', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Ronghao Yu', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Chin-Teng Lin', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Yuanqing Li', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2016.7591003']
844,28268675,Effects of prefrontal anodal transcranial direct current stimulation on working-memory and reaction time.,"Transcranial direct current stimulation (tDCS) has proven to be a useful tool in the scientific research community, particularly for clinical investigation purposes. Neuroimaging studies indicate that there is a connection between the prefrontal cortex (PFC) and working memory (WM), as well as between the primary motor cortex and reaction time (RT). Thus, our goal was to evaluate the effect of anodal stimulation of the PFC, with respect to WM and RT. We tested 20 healthy subjects randomized into two groups - half received active stimulation and the other half sham stimulation. Participants underwent two stimulation sessions of 10 minutes each, separated by a 10-minute interval for rest. The task was performed during the stimulation periods, and consisted in the display of a list of words for the subject to read and memorize. Afterwards, a new list was shown and the subject was asked to to press a key when a repeated word appeared. A current of 1 mA was delivered via a foc.us gamer headset. After both stimulations, the participants answered an Adverse Effects Questionnaire. Statistical tests were performed to compare the accuracy, error rate, and reaction time values for active vs. sham and first vs. second stimulations. The results obtained led us to infer that there were no significant improvements in the performance of the active group in comparison with the sham group, in terms of WM and overall RT values. However, RT data analysis indicated that active simulation subjects showed significantly lower values when compared to the sham group, only for the first stimulation period. Due to emerging technological advances, the videogame industry has started to invest in the commercialization of products that promise to enhance neural functions and, thus, improve gamers' performance. The results obtained provide evidence of the importance of testing such commercial devices. The scientific community should have an active role in the validation of these claims.",2016,"The results obtained led us to infer that there were no significant improvements in the performance of the active group in comparison with the sham group, in terms of WM and overall RT values.",['20 healthy subjects randomized into two groups - half received'],"['active stimulation and the other half sham stimulation', 'Transcranial direct current stimulation (tDCS', 'prefrontal anodal transcranial direct current stimulation']","['Adverse Effects Questionnaire', 'WM and overall RT values', 'prefrontal cortex (PFC) and working memory (WM', 'working-memory and reaction time', 'accuracy, error rate, and reaction time values']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",20.0,0.0583737,"The results obtained led us to infer that there were no significant improvements in the performance of the active group in comparison with the sham group, in terms of WM and overall RT values.","[{'ForeName': 'Ines S', 'Initials': 'IS', 'LastName': 'Verissimo', 'Affiliation': ''}, {'ForeName': 'Isabel M', 'Initials': 'IM', 'LastName': 'Barradas', 'Affiliation': ''}, {'ForeName': 'Tiago T', 'Initials': 'TT', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'Pedro C', 'Initials': 'PC', 'LastName': 'Miranda', 'Affiliation': ''}, {'ForeName': 'Hugo A', 'Initials': 'HA', 'LastName': 'Ferreira', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2016.7591065']
845,28992261,Randomized Trial of 2 Versus 1 Dose of Measles Vaccine: Effect on Hospital Admission of Children After 9 Months of Age.,"Background


Two doses of measles vaccine (MV) might reduce the nonmeasles mortality rate more than 1 dose of MV does. The effect of 2 versus 1 dose on morbidity has not been examined. Within a randomized trial of the effect of 2 doses versus 1 dose of MV on mortality in Guinea-Bissau, we investigated the effect on hospital admissions.
Methods


Children were randomly assigned 1:2 to receive MV at 4.5 and 9 months of age or the currently recommended dose at 9 months. We compared hospital admission rates among children between 9 and 18 months of age in a Cox regression model with age as the underlying time scale. Half of the children had received neonatal vitamin A supplementation (NVAS) in another trial. The beneficial effect of MV at 4.5 and 9 months on mortality was limited to children who had not received NVAS; therefore, we investigated the interaction of MV with NVAS on admission rates.
Results


Among 5626 children (2 doses of MV, 1960 children; 1 dose of MV, 3666), we identified 311 hospital admissions of children between 9 and 18 months of age. Overall, compared to 1 dose of MV, 2 doses reduced the risk of hospital admission for children who had not received NVAS (hazard ratio [HR], 0.66 [95% confidence interval (CI), 0.47-0.93]), but we found no effect among NVAS recipients (HR, 1.16 [95% CI, 0.82-1.63]) (P = .02 for interaction).
Conclusions


The benefit of 2 doses of MV was limited to children who had not received NVAS. NVAS is not generally recommended; hence, an early 2-dose measles vaccination policy might reduce hospital admissions more than the current policy of providing the first MV at 9 months of age.
Trial registration


ClinicalTrials.gov identifier NCT00168558.",2018,"Overall, compared to 1 dose of MV, 2 doses reduced the risk of hospital admission for children who had not received NVAS (hazard ratio [HR], 0.66 [95% confidence interval (CI), 0.47-0.93]), but we found no effect among NVAS recipients (HR, 1.16","['5626 children (2 doses of MV, 1960 children; 1 dose of MV, 3666), we identified 311 hospital admissions of children between 9 and 18 months of age', 'Methods\n\n\nChildren', 'Hospital Admission of Children After 9 Months of Age']","['neonatal vitamin A supplementation (NVAS', 'NVAS', 'measles vaccine (MV', 'Measles Vaccine', 'MV']","['mortality', 'nonmeasles mortality rate', 'risk of hospital admission', 'hospital admission rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",5626.0,0.430291,"Overall, compared to 1 dose of MV, 2 doses reduced the risk of hospital admission for children who had not received NVAS (hazard ratio [HR], 0.66 [95% confidence interval (CI), 0.47-0.93]), but we found no effect among NVAS recipients (HR, 1.16","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Brønd', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Cesario L', 'Initials': 'CL', 'LastName': 'Martins', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Byberg', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Christine S', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Research Center for Vitamins and Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Hilton', 'Initials': 'H', 'LastName': 'Whittle', 'Affiliation': 'London School of Hygiene and Tropical Medicine, United Kingdom.'}, {'ForeName': 'May-Lill', 'Initials': 'ML', 'LastName': 'Garly', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Aaby', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}, {'ForeName': 'Ane B', 'Initials': 'AB', 'LastName': 'Fisker', 'Affiliation': 'Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.'}]",Journal of the Pediatric Infectious Diseases Society,['10.1093/jpids/pix042']
846,32412145,Mind and body: Psychophysiological profiles of instructional and motivational self-talk.,"Self-talk is a psychological skill that benefits motor performance by controlling and organizing performers' thoughts. While the behavioral effects of self-talk are clear, research on the mechanisms underpinning the effects of different modes of self-talk is sparse. To address this issue, we propose and test a psychophysiological model of the effects of self-talk on motor performance. Forty golf novices practiced a golf putting task while using either instructional or motivational self-talk preceding each putt. We measured performance (radial error), technique (club kinematics and muscle activity), cardiac activity (heart-rate and event-related heart-rate change), as well as electroencephalographic alpha power and connectivity in a randomized (group: instructional self-talk, motivational self-talk) experimental design. Instructional self-talk promoted superior technique and was associated with greater parietal alpha power and weaker connectivity between frontal and parietal electrodes and all other scalp sites, possibly indicative of increased top-down control of action. These findings provide initial evidence for an information-processing mechanism underlying the benefits of instructional self-talk. They also cast doubt on the validity of left-frontotemporal connectivity as a measure of verbal-analytic processing during motor tasks. Motivational self-talk led to increased heart-rate and reduced event-related heart rate variability, suggesting an effort-based mechanism to explain the benefits of motivational self-talk. Our study represents the most complete multi-measure investigation of self-talk to date. We hope that our psychophysiological model of self-talk will encourage researchers to move beyond the exclusive reliance on behavioral and self-report measures to discover the mechanisms underlying the benefits of self-talk for performance.",2020,"Instructional self-talk promoted superior technique and was associated with greater parietal alpha power and weaker connectivity between frontal and parietal electrodes and all other scalp sites, possibly indicative of increased top-down control of action.",[],['Mind and body'],"['instructional self-talk, motivational self-talk) experimental design', 'heart-rate', 'performance (radial error), technique (club kinematics and muscle activity), cardiac activity (heart-rate and event-related heart-rate change), as well as electroencephalographic alpha power and connectivity']",[],"[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443168', 'cui_str': 'Cardiac activity'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",,0.0162807,"Instructional self-talk promoted superior technique and was associated with greater parietal alpha power and weaker connectivity between frontal and parietal electrodes and all other scalp sites, possibly indicative of increased top-down control of action.","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bellomo', 'Affiliation': 'Bangor University, Bangor, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cooke', 'Affiliation': 'Bangor University, Bangor, United Kingdom.'}, {'ForeName': 'Germano', 'Initials': 'G', 'LastName': 'Gallicchio', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ring', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hardy', 'Affiliation': 'Bangor University, Bangor, United Kingdom.'}]",Psychophysiology,['10.1111/psyp.13586']
847,31808594,Ivermectin for causal malaria prophylaxis: a randomised controlled human infection trial.,"OBJECTIVE


Ivermectin is safe and widely used for treating helminth infections. It also kills arthropods feeding on treated subjects, including malaria vectors. Thus, ivermectin mass drug administration as an additional tool for malaria control is being evaluated by WHO. As in vitro data, animal experiments and epidemiological observations suggest that ivermectin has a direct effect on the liver stages of the malaria parasite, this study was designed to assess the prophylactic effect of ivermectin on Plasmodium falciparum controlled human malaria infection.
METHODS


A total of 4 volunteers were randomised to placebo, and 8 volunteers were randomised to receive ivermectin 0.4 mg/kg, orally, once 2 h before being experimentally infected intravenously with 3200 P. falciparum sporozoites. The primary endpoint was time to parasitaemia detected by positive thick blood smear; RT-qPCR was performed in parallel.
RESULTS


All but one volunteer became thick blood smear positive between day 11 and day 12 after infection, and there was no significant effect of ivermectin on parasitaemia.
CONCLUSION


Ivermectin - at the dose used - has no clinically relevant activity against the pre-erythrocytic stages of P. falciparum.",2020,"CONCLUSION


Ivermectin - at the dose used - has no clinically relevant activity against the pre-erythrocytic stages of P. falciparum.",['A total of 4 volunteers'],"['placebo', 'ivermectin', 'Ivermectin']","['parasitaemia', 'time to parasitaemia detected by positive thick blood smear; RT-qPCR', 'thick blood smear positive']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1280412', 'cui_str': 'Thick (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}]",,0.120553,"CONCLUSION


Ivermectin - at the dose used - has no clinically relevant activity against the pre-erythrocytic stages of P. falciparum.","[{'ForeName': 'Wolfram G', 'Initials': 'WG', 'LastName': 'Metzger', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Theurer', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Pfleiderer', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Zsofia', 'Initials': 'Z', 'LastName': 'Molnar', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Ditte', 'Initials': 'D', 'LastName': 'Maihöfer-Braatting', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Alfred L', 'Initials': 'AL', 'LastName': 'Bissinger', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Zita', 'Initials': 'Z', 'LastName': 'Sulyok', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Köhler', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Egger-Adam', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Lalremruata', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Lee Sim', 'Affiliation': 'Sanaria Inc., Rockville, MD, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc., Rockville, MD, USA.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Rabinovich', 'Affiliation': 'Instituto de Salud Global, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Chaccour', 'Affiliation': 'Instituto de Salud Global, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Alonso', 'Affiliation': 'Instituto de Salud Global, Barcelona, Spain.'}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Mordmüller', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kremsner', 'Affiliation': 'Institute for Tropical Medicine, German Center for Infection Research, Tübingen, Germany.'}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13357']
848,31590702,Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT.,"BACKGROUND


Sepsis is a leading cause of direct and indirect maternal death in both the UK and globally. All forms of operative delivery are associated with an increased risk of sepsis, and the National Institute for Health and Care Excellence's guidance recommends the use of prophylactic antibiotics at all caesarean deliveries, based on substantial randomised controlled trial evidence of clinical effectiveness. A Cochrane review, updated in 2017 (Liabsuetrakul T, Choobun T, Peeyananjarassri K, Islam QM. Antibiotic prophylaxis for operative vaginal delivery.  Cochrane Database Syst Rev  2017; 8 :CD004455), identified only one small previous trial of prophylactic antibiotics following operative vaginal birth (forceps or ventouse/vacuum extraction) and, given the small study size and extreme result, suggested that further robust evidence is needed.
OBJECTIVES


To investigate whether or not a single dose of prophylactic antibiotic following operative vaginal birth is clinically effective for preventing confirmed or presumed maternal infection, and to investigate the associated impact on health-care costs.
DESIGN


A multicentre, randomised, blinded, placebo-controlled trial.
SETTING


Twenty-seven maternity units in the UK.
PARTICIPANTS


Women who had an operative vaginal birth at ≥ 36 weeks' gestation, who were not known to be allergic to penicillin or constituents of co-amoxiclav and who had no indication for ongoing antibiotics.
INTERVENTIONS


A single dose of intravenous co-amoxiclav (1 g of amoxicillin/200 mg of clavulanic acid) or placebo (sterile saline) allocated through sealed, sequentially numbered, indistinguishable packs.
MAIN OUTCOME MEASURES


Primary outcome - confirmed or suspected infection within 6 weeks of giving birth. Secondary outcomes - severe sepsis, perineal wound infection, perineal pain, use of pain relief, hospital bed stay, hospital/general practitioner visits, need for additional perineal care, dyspareunia, ability to sit comfortably to feed the baby, maternal general health, breastfeeding, wound breakdown, occurrence of anaphylaxis and health-care costs.
RESULTS


Between March 2016 and June 2018, 3427 women were randomised: 1719 to the antibiotic arm and 1708 to the placebo arm. Seven women withdrew, leaving 1715 women in the antibiotic arm and 1705 in the placebo arm for analysis. Primary outcome data were available for 3225 out of 3420 women (94.3%). Women randomised to the antibiotic arm were significantly less likely to have confirmed or suspected infection within 6 weeks of giving birth (180/1619, 11%) than women randomised to the placebo arm (306/1606, 19%) (relative risk 0.58, 95% confidence interval 0.49 to 0.69). Three serious adverse events were reported: one in the placebo arm and two in the antibiotic arm (one was thought to be causally related to the intervention).
LIMITATIONS


The follow-up rate achieved for most secondary outcomes was 76%.
CONCLUSIONS


This trial has shown clear evidence of benefit of a single intravenous dose of prophylactic co-amoxiclav after operative vaginal birth. These results may lead to reconsideration of official policy/guidance. Further analysis of the mechanism of action of this single dose of antibiotic is needed to investigate whether earlier, pre-delivery or repeated administration could be more effective. Until these analyses are completed, there is no indication for administration of more than a single dose of prophylactic antibiotic, or for pre-delivery administration.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN11166984.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 54. See the National Institute for Health Research Journals Library website for further project information.",2019,"Women randomised to the antibiotic arm were significantly less likely to have confirmed or suspected infection within 6 weeks of giving birth (180/1619, 11%) than women randomised to the placebo arm (306/1606, 19%) (relative risk 0.58, 95% confidence interval 0.49 to 0.69).","['Between March 2016 and June 2018', '3427 women were randomised: 1719 to the antibiotic arm and 1708 to the', ""Women who had an operative vaginal birth at ≥\u200936 weeks' gestation, who were not known to be allergic to penicillin or constituents of co-amoxiclav and who had no indication for ongoing antibiotics"", 'Seven women withdrew, leaving 1715 women in the antibiotic arm and 1705 in the', 'Twenty-seven maternity units in the UK']","['Antibiotic prophylaxis', 'prophylactic antibiotic', 'Intravenous co-amoxiclav', 'placebo', 'prophylactic antibiotics', 'operative vaginal birth (forceps or ventouse/vacuum extraction', 'intravenous co-amoxiclav (1\u2009g of amoxicillin/200\u2009mg of clavulanic acid) or placebo (sterile saline']","['suspected infection within 6 weeks of giving birth', 'serious adverse events', 'severe sepsis, perineal wound infection, perineal pain, use of pain relief, hospital bed stay, hospital/general practitioner visits, need for additional perineal care, dyspareunia, ability to sit comfortably to feed the baby, maternal general health, breastfeeding, wound breakdown, occurrence of anaphylaxis and health-care costs']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0030842', 'cui_str': 'Antibiotics, Penicillin'}, {'cui': 'C0729650', 'cui_str': 'Constituents (substance)'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin / Clavulanate'}, {'cui': 'C0521090', 'cui_str': 'No indication of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin / Clavulanate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0042225', 'cui_str': 'Delivery, Vacuum Extraction'}, {'cui': 'C0055860', 'cui_str': 'Clavulanic Acid'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0240717', 'cui_str': 'Perineal pain (finding)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0336603', 'cui_str': 'Hospital bed'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0150301', 'cui_str': 'Perineal care (regime/therapy)'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0560879', 'cui_str': 'Ability to sit (observable entity)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038940', 'cui_str': 'Surgical Wound Dehiscence'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",3420.0,0.615428,"Women randomised to the antibiotic arm were significantly less likely to have confirmed or suspected infection within 6 weeks of giving birth (180/1619, 11%) than women randomised to the placebo arm (306/1606, 19%) (relative risk 0.58, 95% confidence interval 0.49 to 0.69).","[{'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Knight', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Chiocchia', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Partlett', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Rivero-Arias', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Xinyang', 'Initials': 'X', 'LastName': 'Hua', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Bowler', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gray', 'Affiliation': ""Department of Microbiology, Birmingham Women's & Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hinshaw', 'Affiliation': 'Department of Obstetrics and Gynaecology, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Aethele', 'Initials': 'A', 'LastName': 'Khunda', 'Affiliation': ""Department of Women's Health, James Cook University Hospital, Middlesbrough, UK.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Moore', 'Affiliation': ""Department of Microbiology, Birmingham Women's & Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mottram', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Owino', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dharmintra', 'Initials': 'D', 'LastName': 'Pasupathy', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, King's Health Partners, London, UK.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Abdul H', 'Initials': 'AH', 'LastName': 'Sultan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Croydon University Hospital, Croydon, UK.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Thakar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Croydon University Hospital, Croydon, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Tuffnell', 'Affiliation': ""Department of Women's Health, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23540']
849,28277699,Harnessing the placebo effect: Exploring the influence of physician characteristics on placebo response.,"OBJECTIVE


Research on placebo/nocebo effects suggests that expectations can influence treatment outcomes, but placebo/nocebo effects are not always evident. This research demonstrates that a provider's social behavior moderates the effect of expectations on physiological outcomes.
METHODS


After inducing an allergic reaction in participants through a histamine skin prick test, a health care provider administered a cream with no active ingredients and set either positive expectations (cream will reduce reaction) or negative expectations (cream will increase reaction). The provider demonstrated either high or low warmth, or either high or low competence.
RESULTS


The impact of expectations on allergic response was enhanced when the provider acted both warmer and more competent and negated when the provider acted colder and less competent.
CONCLUSION


This study suggests that placebo effects should be construed not as a nuisance variable with mysterious impact but instead as a psychological phenomenon that can be understood and harnessed to improve treatment outcomes. (PsycINFO Database Record",2017,"The impact of expectations on allergic response was enhanced when the provider acted both warmer and more competent and negated when the provider acted colder and less competent.
","['participants through a histamine skin prick test, a health care provider administered a']","['cream with no active ingredients and set either positive expectations (cream will reduce reaction) or negative expectations (cream', 'placebo']",['allergic response'],"[{'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.287479,"The impact of expectations on allergic response was enhanced when the provider acted both warmer and more competent and negated when the provider acted colder and less competent.
","[{'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Howe', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'J Parker', 'Initials': 'JP', 'LastName': 'Goyer', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Alia J', 'Initials': 'AJ', 'LastName': 'Crum', 'Affiliation': 'Department of Psychology, Stanford University.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000499']
850,28291393,Early Positron Emission Tomography Response-Adapted Treatment in Stage I and II Hodgkin Lymphoma: Final Results of the Randomized EORTC/LYSA/FIL H10 Trial.,"Purpose Patients who receive combined modality treatment for stage I and II Hodgkin lymphoma (HL) have an excellent outcome. Early response evaluation with positron emission tomography (PET) scan may improve selection of patients who need reduced or more intensive treatments. Methods We performed a randomized trial to evaluate treatment adaptation on the basis of early PET (ePET) after two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in previously untreated-according to European Organisation for Research and Treatment of Cancer criteria favorable (F) and unfavorable (U)-stage I and II HL. The standard arm consisted of ABVD followed by involved-node radiotherapy (INRT), regardless of ePET result. In the experimental arm, ePET-negative patients received ABVD only (noninferiority design), whereas ePET-positive patients switched to two cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) and INRT (superiority design). Primary end point was progression-free survival (PFS). Results Of 1,950 randomly assigned patients, 1,925 received an ePET-361 patients (18.8%) were positive. In ePET-positive patients, 5-year PFS improved from 77.4% for standard ABVD + INRT to 90.6% for intensification to BEACOPPesc + INRT (hazard ratio [HR], 0.42; 95% CI, 0.23 to 0.74; P = .002). In ePET-negative patients, 5-year PFS rates in the F group were 99.0% versus 87.1% (HR, 15.8; 95% CI, 3.8 to 66.1) in favor of ABVD + INRT; the U group, 92.1% versus 89.6% (HR, 1.45; 95% CI, 0.8 to 2.5) in favor of ABVD + INRT. For both F and U groups, noninferiority of ABVD only compared with combined modality treatment could not be demonstrated. Conclusion In stage I and II HL, PET response after two cycles of ABVD allows for early treatment adaptation. When ePET is positive after two cycles of ABVD, switching to BEACOPPesc + INRT significantly improved 5-year PFS. In ePET-negative patients, noninferiority of ABVD only could not be demonstrated: risk of relapse is increased when INRT is omitted, especially in patients in the F group.",2017,"In ePET-negative patients, 5-year PFS rates in the F group were 99.0% versus 87.1% (HR, 15.8; 95% CI, 3.8 to 66.1) in favor of ABVD + INRT; the U group, 92.1% versus 89.6% (HR, 1.45; 95% CI, 0.8 to 2.5) in favor of ABVD + INRT.","['Purpose Patients who receive combined modality treatment for stage I and II Hodgkin lymphoma (HL', 'patients who need reduced or more intensive treatments', 'previously untreated-according to European Organisation for Research and Treatment of Cancer criteria favorable (F) and unfavorable (U)-stage I and II HL', 'Stage', '1,950 randomly assigned patients', 'I and II Hodgkin Lymphoma']","['BEACOPPesc + INRT', 'positron emission tomography (PET) scan', 'INRT', 'ABVD followed by involved-node radiotherapy (INRT', 'doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD', 'bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) and INRT']","['5-year PFS rates', 'progression-free survival (PFS', 'risk of relapse', '5-year PFS']","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0441633'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0033223', 'cui_str': 'Procarbazine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",1950.0,0.208169,"In ePET-negative patients, 5-year PFS rates in the F group were 99.0% versus 87.1% (HR, 15.8; 95% CI, 3.8 to 66.1) in favor of ABVD + INRT; the U group, 92.1% versus 89.6% (HR, 1.45; 95% CI, 0.8 to 2.5) in favor of ABVD + INRT.","[{'ForeName': 'Marc P E', 'Initials': 'MPE', 'LastName': 'André', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Théodore', 'Initials': 'T', 'LastName': 'Girinsky', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Federico', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Oumédaly', 'Initials': 'O', 'LastName': 'Reman', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fortpied', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Gotti', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Brice', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van der Maazen', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Re', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Edeline', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Fermé', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Gustaaf', 'Initials': 'G', 'LastName': 'van Imhoff', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Merli', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Réda', 'Initials': 'R', 'LastName': 'Bouabdallah', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sebban', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Specht', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Aspasia', 'Initials': 'A', 'LastName': 'Stamatoullas', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Delarue', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Fiaccadori', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bellei', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Tiana', 'Initials': 'T', 'LastName': 'Raveloarivahy', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Annibale', 'Initials': 'A', 'LastName': 'Versari', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hutchings', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Meignan', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Raemaekers', 'Affiliation': ""Marc P.E. André, Université Catholique de Louvain, Yvoir; Catherine Fortpied, Valeria Fiaccadori, and Tiana Raveloarivahy, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Théodore Girinsky and Christophe Fermé, Institut Gustave Roussy, Villejuif; Oumédaly Reman, Institut d'Hématologie de Basse Normandie, Centre Hospitalier Universitaire, Caen; Pauline Brice, Assistance Publique des Hopitaux de Paris Hôpital Saint-Louis; Richard Delarue, Assistance Publique des Hopitaux de Paris Hôpital Universitaire Necker-Enfants Maladies, Paris; Olivier Casasnovas, Centre Hospitalier Universitaire le Bocage and Institut National de la Santé et de la Recherche Médicale, Dijon; Véronique Edeline, Hôpital René Hugenin-Institut Curie, Saint Cloud; Réda Bouabdallah, Institut Paoli Calmette, Marseille; Catherine Sebban, Hematology Centre Léon Bérard, Lyon; Aspasia Stamatoullas, Centre Henri Becquerel, Rouen; Michel Meignan, Henri Mondor University Hospitals, Créteil, France; Massimo Federico and Monica Bellei, University of Modena and Reggio Emilia, Modena; Manuel Gotti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia; Alessandro Re, Spedali Civili Hospital, Brescia; Francesco Merli and Annibale Versari, Arcispedale Santa Maria Nuova Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy; Richard van der Maazen and John Raemaekers, Radboud University Medical Center, Nijmegen; Gustaaf van Imhoff, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands; and Lena Specht and Martin Hutchings, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2016.68.6394']
851,28324932,An ICT and mobile health integrated approach to optimize patients' education on hypertension and its management by physicians: The Patients Optimal Strategy of Treatment(POST) pilot study.,"INTRODUCTION


Uncontrolled hypertension is largely attributed to unsatisfactory doctor's engagement in its optimal management and to poor patients' compliance to therapeutic interventions. ICT and mobile Health solutions might improve these conditions, being widely available and providing highly effective communication strategies.
OBJECTIVE


To evaluate whether ICT and mobile Health tools are able to improve hypertension control by improving doctors' engagement and by increasing patients' education and involvement, and their compliance to lifestyle modification and prescribed drug therapy.
METHODS


In a pilot study, we have included 690 treated hypertensive patients with uncontrolled office blood pressure (BP), consecutively recruited by 9 general practitioners over 3 months. Patients were alternatively assigned to routine management based on repeated office visits or to an integrated ICT-based Patients Optimal Strategy for Treatment (POST) system including Home BP monitoring teletransmission, a dedicated web-based platform for patients' management by physicians (Misuriamo platform), and a smartphone mobile application (Eurohypertension APP, E-APP), over a follow-up of 6 months. BP values, demographic and clinical data were collected at baseline and at all follow-up visits (at least two). BP control and cardiovascular risk level have been evaluated at the beginning and at the end of the study.
RESULTS


89 patients did not complete the follow-up, thus data analysis was carried out in 601 of them (303 patients in the POST group and 298 in the control group). Office BP control (<;149/90 mmHg) was 40.0% in control group, and 72.3% in POST group at 6 month follow-up. At the same time Home BP control (<;135/85 mmHg average of 6 days) in POST group was 87.5%.
CONCLUSION


this pilot study suggests that ICT based tools might be effective in improving hypertension management, implementing positive patients' involvement with better adherence to treatment prescriptions and providing the physicians with dynamic control of patients' home BP measurements, resulting in lesser clinical inertia.",2016,"To evaluate whether ICT and mobile Health tools are able to improve hypertension control by improving doctors' engagement and by increasing patients' education and involvement, and their compliance to lifestyle modification and prescribed drug therapy.
","['690 treated hypertensive patients with uncontrolled office blood pressure (BP), consecutively recruited by 9 general practitioners over 3 months', ""patients' education on hypertension and its management by physicians""]","[""routine management based on repeated office visits or to an integrated ICT-based Patients Optimal Strategy for Treatment (POST) system including Home BP monitoring teletransmission, a dedicated web-based platform for patients' management by physicians (Misuriamo platform), and a smartphone mobile application (Eurohypertension APP, E-APP"", 'ICT', 'ICT and mobile Health solutions']","['BP control and cardiovascular risk level', 'BP values, demographic and clinical data']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",690.0,0.0241666,"To evaluate whether ICT and mobile Health tools are able to improve hypertension control by improving doctors' engagement and by increasing patients' education and involvement, and their compliance to lifestyle modification and prescribed drug therapy.
","[{'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Albini', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Xiaoqiu Liu', 'Affiliation': ''}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Torlasco', 'Affiliation': ''}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Soranna', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Faini', 'Affiliation': ''}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ciminaghi', 'Affiliation': ''}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Celsi', 'Affiliation': ''}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Benedetti', 'Affiliation': ''}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Zambon', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'di Rienzo', 'Affiliation': ''}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Parati', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2016.7590753']
852,28325013,Mirror therapy combined with functional electrical stimulation for rehabilitation of stroke survivors' ankle dorsiflexion.,"This study investigates the effect of combining both mirror therapy with Electrical Stimulation (ES) on improvement of the function of lower extremity compared to conventional therapy. 18 stroke survivors (sub acute stage) were recruited, 9 of them were randomly assigned to receive conventional treatment and another 9 started the mirror therapy combined with ES treatment. Duration of each session in both interventions was 50 minutes, done 4 times per week over two weeks. After 2 weeks, subjects took one week rest before switching they type of treatment; those started with conventional therapy continued with mirror therapy combined with ES, and vice versa. The duration of this phase was 2 weeks with same schedule as the 1st one. Ankle dorsi-flexion range of motion, lower extremity sensory-motor function, and walking duration were measured at baseline, after 1st 2 weeks, and immediately after the last two weeks, and 4 weeks after end of training (retention test). Repeated Measures ANCOVA was done to compare outcome measures scores in both groups and between all testing days, and paired T-test was used measure the difference between groups. Significant increase in all outcome measures was found after the (MT+ES) training, which is higher than conventional therapy training (p<;0.0001). In conclusion, the results suggest that combination of mirror therapy and ES is more effective than conventional therapy in improving lower limb motor function after stroke.",2016,"Significant increase in all outcome measures was found after the (MT+ES) training, which is higher than conventional therapy training (p<;0.0001).","[""stroke survivors' ankle dorsiflexion"", '18 stroke survivors (sub acute stage']","['mirror therapy with Electrical Stimulation (ES', 'Mirror therapy combined with functional electrical stimulation', 'conventional treatment and another 9 started the mirror therapy combined with ES treatment', 'conventional therapy continued with mirror therapy combined with ES, and vice versa']","['Ankle dorsi-flexion range of motion, lower extremity sensory-motor function, and walking duration']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0313873,"Significant increase in all outcome measures was found after the (MT+ES) training, which is higher than conventional therapy training (p<;0.0001).","[{'ForeName': 'Ghadir', 'Initials': 'G', 'LastName': 'Salhab', 'Affiliation': ''}, {'ForeName': 'Ahmad Rifaii', 'Initials': 'AR', 'LastName': 'Sarraj', 'Affiliation': ''}, {'ForeName': 'Soha', 'Initials': 'S', 'LastName': 'Saleh', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2016.7591776']
853,28269510,Network effects and pathways in Deep brain stimulation in Parkinson's disease.,"Deep brain stimulation of subthalamic nucleus (STN-DBS) became a standard therapeutic option in Parkinson's disease (PD), even though the underlying modulated network of STN-DBS is still poorly described. Probabilistic tractography and connectivity analysis as derived from diffusion tensor imaging (DTI) were performed together with modelling of implanted electrode positions and linked postoperative clinical outcome. Fifteen patients with idiopathic PD without dementia were selected for DBS treatment. After pre-processing, probabilistic tractography was run from cortical and subcortical seeds of the hypothesized network to targets represented by the positions of the active DBS contacts. The performed analysis showed that the projections of the stimulation site to supplementary motor area (SMA) and primary motor cortex (M1) are mainly involved in the network effects of STN-DBS. An involvement of the ""hyperdirected pathway"" and a clear delimitation of the cortico-spinal tract were demonstrated. This study shows the effects of STN-DBS in PD distinctly rely on the network connections of the stimulated region to M1 and SMA, motor and premotor regions.",2016,"An involvement of the ""hyperdirected pathway"" and a clear delimitation of the cortico-spinal tract were demonstrated.","[""Parkinson's disease"", 'Fifteen patients with idiopathic PD without dementia were selected for DBS treatment', ""Parkinson's disease (PD""]","['STN-DBS', 'Deep brain stimulation of subthalamic nucleus (STN-DBS']",[],"[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0152355', 'cui_str': 'Nucleus Subthalamicus'}]",[],15.0,0.0347222,"An involvement of the ""hyperdirected pathway"" and a clear delimitation of the cortico-spinal tract were demonstrated.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Koirala', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Fleischer', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Granert', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Deuschl', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Muthuraman', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Groppa', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2016.7591980']
854,31851001,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND


There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS


Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS


A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 1.83 (95% confidence interval: 1.145-2.201)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS


This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2019,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['simple appendicitis (SA) in children', '304 patients were randomized', 'One hundred twenty-two patients received', 'Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution']","['Laparoscopic Appendicectomy', 'placebo or antibiotics (Abx', 'placebo', 'laparoscopic appendicectomy']","['intra-abdominal abscess', 'WI rates', 'postoperative length of stay in a hospital', 'incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation']","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0243001', 'cui_str': 'Abscess, Intra-Abdominal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",243.0,0.816238,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
855,32412195,[Locoregional anesthesia in endoscopic surgery of intracerebral hypertensive hemangiomas].,"Introduction


Currently, minimally invasive methods of surgical treatment of hypertensive intracerebral hematomas (ICHs) are actively used. However, anesthetic management of these surgeries are unclear. Moreover, advisability of locoregional anesthesia (LRA) for endoscopic aspiration of hypertensive ICHs has not been studied.
Objective


To analyze application of regional anesthesia in minimally invasive surgery of hypertensive intracerebral hematomas.
Material and methods


Patients were divided into 2 groups. Group 1 included 45 patients who underwent surgery under total intravenous anesthesia with mechanical ventilation (TIVA + mechanical ventilation), group 2 (n=43) - surgery under LRA. The incidence of pneumonia and postoperative outcomes in accordance with the GOS grading system were analyzed depending on the method of anesthesia.
Results


Pneumonia was 3 times more common in the first group (33%) that required prolonged ventilation and tracheostomy. Thus, there were 9 tracheostomies (20%) in the first group. In the second group, one patient required mechanical ventilation on the second postoperative day due to severe chronic obstructive pulmonary disease followed by deterioration of respiratory failure. Tracheostomy was also performed in this case. According to analysis of GOS outcomes, the LRA group was characterized by 4 times lower mortality and 1.5 times greater number of patients with good recovery and moderate disabilities compared with the first group.
Conclusions


LRA is a feasible and effective method for the anesthetic management of minimally invasive surgery in patients with hypertensive ICHs. This approach ensures decrease of mortality rate, increase of good neurological outcomes and reduce pulmonary infectious complications.",2020,"According to analysis of GOS outcomes, the LRA group was characterized by 4 times lower mortality and 1.5 times greater number of patients with good recovery and moderate disabilities compared with the first group.
","['45 patients who underwent', 'minimally invasive surgery of hypertensive intracerebral hematomas', 'intracerebral hypertensive hemangiomas', 'hypertensive intracerebral hematomas (ICHs', 'patients with hypertensive ICHs']","['Locoregional anesthesia', 'regional anesthesia', 'mechanical ventilation', 'surgery under total intravenous anesthesia with mechanical ventilation (TIVA + mechanical ventilation), group 2 (n=43) - surgery under LRA']","['severe chronic obstructive pulmonary disease followed by deterioration of respiratory failure', 'pulmonary infectious complications', 'mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0021870', 'cui_str': 'Intracerebral hematoma'}, {'cui': 'C0442111', 'cui_str': 'Intracerebral'}, {'cui': 'C0018916', 'cui_str': 'Hemangioma'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",45.0,0.0176614,"According to analysis of GOS outcomes, the LRA group was characterized by 4 times lower mortality and 1.5 times greater number of patients with good recovery and moderate disabilities compared with the first group.
","[{'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Tsilina', 'Affiliation': 'City Clinical Emergency Hospital No. 1, Omsk, Russia.'}, {'ForeName': 'Ya A', 'Initials': 'YA', 'LastName': 'Shesterikov', 'Affiliation': 'City Clinical Emergency Hospital No. 1, Omsk, Russia.'}, {'ForeName': 'V G', 'Initials': 'VG', 'LastName': 'Dashyan', 'Affiliation': 'A.I. Evdokimov Moscow State Medical and Dental University, Moscow, Russia.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Petrikov', 'Affiliation': 'A.I. Evdokimov Moscow State Medical and Dental University, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Govorova', 'Affiliation': 'Omsk State Medical University, Omsk, Russia.'}]",Zhurnal voprosy neirokhirurgii imeni N. N. Burdenko,['10.17116/neiro20208402165']
856,28491999,Treatment of lateral canthal rhytides with a medium depth chemical peel with or without pretreatment with onabotulinum toxin type A: a randomized control trial.,"BACKGROUND


Combination therapies used to treat the photoaged skin have become more popular as studies demonstrate greater efficacy and improved clinical outcomes compared to single treatment modalities.
OBJECTIVES


To evaluate the safety and effectiveness of treating the lateral canthal rhytide complex with a Jessner's and 35% TCA peel with and without pretreatment with BTX-A.
METHODS


Twenty-six subjects with Fitzpatrick skin types I -III were randomized to receive treatment of their lateral canthal rhytide complex with a Jessner's and 35% TCA peel with or without pretreatment with BTX-A. A single blinded dermatologist assigned a lateral canthal wrinkle score of subjects' at baseline and week 8-10.
RESULTS


Comparison between the two treatment groups demonstrated that the group receiving combination treatment had significantly greater improvement in wrinkle reduction as compared to the group only receiving the chemical peel (P =0.002). In addition, there was no significant association between skin type and treatment groups (P = 0.11).
CONCLUSIONS


These findings suggest that treating the lateral canthal rhytide complex with a combination of BTX-A followed by Jessner's and 35% TCA peel is more effective than chemical peel alone. These results are independent of skin type and demonstrate an additional treatment strategy for lateral canthal rhytides.",2016,"RESULTS


Comparison between the two treatment groups demonstrated that the group receiving combination treatment had significantly greater improvement in wrinkle reduction as compared to the group only receiving the chemical peel (P =0.002).",['Twenty-six subjects with Fitzpatrick skin types'],"['lateral canthal rhytides with a medium depth chemical peel with or without pretreatment with onabotulinum toxin type A', ""lateral canthal rhytide complex with a Jessner's and 35% TCA peel with or without pretreatment with BTX-A. A single blinded dermatologist assigned a lateral canthal wrinkle score of subjects' at baseline and week 8-10"", ""lateral canthal rhytide complex with a Jessner's and 35% TCA peel with and without pretreatment with BTX""]","['safety and effectiveness', 'wrinkle reduction']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C2729169', 'cui_str': 'Wrinkled structure (morphologic abnormality)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0411412', 'cui_str': 'Chemical peeling of skin lesion (procedure)'}, {'cui': 'C0445349', 'cui_str': 'Toxin typing (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",26.0,0.0431913,"RESULTS


Comparison between the two treatment groups demonstrated that the group receiving combination treatment had significantly greater improvement in wrinkle reduction as compared to the group only receiving the chemical peel (P =0.002).","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Tung', 'Affiliation': 'Loyola Medical Center, Mawood, Illinois.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Mahoney', 'Affiliation': 'Loyola Medical Center, Mawood, Illinois.'}, {'ForeName': 'Karlee', 'Initials': 'K', 'LastName': 'Novice', 'Affiliation': 'Loyola Medical Center, Mawood, Illinois.'}, {'ForeName': 'Loebat', 'Initials': 'L', 'LastName': 'Kamalpour', 'Affiliation': 'Loyola Medical Center, Mawood, Illinois.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Dubina', 'Affiliation': 'Loyola Medical Center, Mawood, Illinois.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hancock', 'Affiliation': 'Loyola Medical Center, Mawood, Illinois.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Krol', 'Affiliation': 'Loyola Medical Center, Mawood, Illinois.'}]",International journal of women's dermatology,['10.1016/j.ijwd.2015.12.006']
857,30803411,Treatment of Toxic Multinodular Goiter: Comparison of Radioiodine and Long-Term Methimazole Treatment.,"Background:  This study aimed to compare the effectiveness and safety of long-term methimazole (MMI) and radioiodine (RAI) in the treatment of toxic multinodular goiter (TMNG).  Methods:  In this randomized, parallel-group trial, 130 consecutive and untreated patients with TMNG, aged <60 years, were enrolled and randomized to either long-term MMI or RAI treatment. Both groups of patients were followed for 60-100 months, with median durations of 72 and 84 months in the MMI and RAI groups, respectively.  Results:  In the MMI and RAI groups, 12 and 11 patients, respectively, were excluded because of side effects, choosing other modes of treatment and not returning for follow-up; 53 and 54 patients, respectively, completed the study for 60-100 months. In the MMI group, two patients (3.8%) experienced subclinical hypothyroidism, and 51 (96.2%) remained euthyroid until the end of study. The dosage of MMI to maintain euthyroidism was 6.3 ± 2.0, 4.5 ± 0.9, and 4.1 ± 1.0 mg daily during the first, third, and fifth years of continuous MMI treatment. One patient had elevated liver enzymes, and three developed skin reactions during the first three months, but no adverse effects from MMI occurred from 4 to 100 months of therapy. In the RAI group, 22 (41%) became hypothyroid, 12 (22%) had persistence or recurrence of hyperthyroidism, and 20 (37%) became euthyroid after 16.7 ± 2.7 mCi  131 I.  Conclusion:  Long-term, low-dose MMI treatment for 60-100 months is a safe and effective method for treatment of TMNG, and is not inferior to RAI treatment.",2019,"One patient had elevated liver enzymes, and three developed skin reactions during the first three months, but no adverse effects from MMI occurred from 4 to 100 months of therapy.","['130 consecutive and untreated patients with TMNG, aged <60 years', 'Toxic Multinodular Goiter', 'toxic multinodular goiter (TMNG']","['long-term MMI or RAI treatment', 'Radioiodine', 'long-term methimazole (MMI) and radioiodine (RAI']","['skin reactions', 'subclinical hypothyroidism', 'persistence or recurrence of hyperthyroidism', 'elevated liver enzymes']","[{'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0154143', 'cui_str': 'Toxic multinodular goiter (disorder)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025644', 'cui_str': 'thiamazole'}]","[{'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2609423', 'cui_str': 'Hyperthyroidism (SMQ)'}, {'cui': 'C0235996', 'cui_str': 'Hepatic enzyme increased'}]",130.0,0.0474589,"One patient had elevated liver enzymes, and three developed skin reactions during the first three months, but no adverse effects from MMI occurred from 4 to 100 months of therapy.","[{'ForeName': 'Fereidoun', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': '1 Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Miralireza', 'Initials': 'M', 'LastName': 'Takyar', 'Affiliation': '1 Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Madreseh', 'Affiliation': '1 Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atieh', 'Initials': 'A', 'LastName': 'Amouzegar', 'Affiliation': '1 Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2018.0397']
858,28269449,Implantable gastric electric stimulator with automatic daily activity compliance reporting.,"In order for any obesity therapy to be successful real behavior change by the individual is required. We present an implantable obesity therapy that combines gastric electrical stimulation for satiety with onboard sensors that provide self-monitoring for the patient and compliance reporting to the clinician. An algorithm for processing data from the onboard three axis accelerometer for use in physical activity monitoring was developed and validated. Four obese patients participated in a study where self-reported sleep and exercise was compared with the events detected by the implanted system, and two commercially available, wearable activity monitors.",2016,We present an implantable obesity therapy that combines gastric electrical stimulation for satiety with onboard sensors that provide self-monitoring for the patient and compliance reporting to the clinician.,['Four obese patients'],[],[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],4.0,0.0146529,We present an implantable obesity therapy that combines gastric electrical stimulation for satiety with onboard sensors that provide self-monitoring for the patient and compliance reporting to the clinician.,"[{'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Takami', 'Affiliation': ''}, {'ForeName': 'Javier J', 'Initials': 'JJ', 'LastName': 'Sanchez', 'Affiliation': ''}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Province', 'Affiliation': ''}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Torres', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2016.7591912']
859,28269582,Progressive abduction loading therapy targeting flexion synergy to regain reaching function in chronic stroke: Preliminary results from an RCT.,"Reaching function is impaired following stroke due to abnormal coupling of shoulder abduction and elbow flexion. This phenomenon is commonly referred to as flexion synergy, loss of independent joint control, or impaired joint individuation. We have been successful in treating individuals with chronic stroke with moderate to severe motor impairments through the employment of targeted rehabilitation robotics and identified progressive abduction loading as a key element to the rehabilitation of reaching. Here we expand upon the investigation of progressive abduction loading therapy by testing two variants of the exercise in a larger sample and including a 3-month follow-up. Furthermore, we attempt to glean additional insights into the mechanisms underlying improvements by not only assessing reaching distance as a function of abduction loading but, for the first time, assessing peak reaching velocity, a combined measure of dynamic elbow and shoulder strength. Thirty-one participants with severe stroke were randomized to two intervention variants. Preliminary analysis has been performed and results are presented for blinded combined-group data. Following the intervention, there was a significant improvement in both reaching distance and peak reaching velocity. Mechanisms for improvement are briefly discussed.",2016,"Following the intervention, there was a significant improvement in both reaching distance and peak reaching velocity.","['Thirty-one participants with severe stroke', 'individuals with chronic stroke with moderate to severe motor impairments', 'chronic stroke']",['Progressive abduction loading therapy targeting flexion synergy'],['reaching distance and peak reaching velocity'],"[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]",31.0,0.026861,"Following the intervention, there was a significant improvement in both reaching distance and peak reaching velocity.","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Ellis', 'Affiliation': ''}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Carmona', 'Affiliation': ''}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Drogos', 'Affiliation': ''}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Traxel', 'Affiliation': ''}, {'ForeName': 'Julius P A', 'Initials': 'JP', 'LastName': 'Dewald', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2016.7592055']
860,28060675,Communicating breast cancer risk information to young adult women: A pilot study.,"OBJECTIVE


To examine the effectiveness of a health promotion flyer to increase awareness of breast cancer risk and physical activity as a risk reduction strategy in young adult women.
METHODS


Young adult women (N = 123) viewed one of five health promotion flyers online and then completed measures of perceived breast cancer risk (PR) and perceived informativeness (PI) and a qualitative thought-listing activity.
RESULTS


Differences were observed in PI such that the control and low risk/low information messages were significantly less informative than the others. Qualitative analyses revealed two general themes: message content and flyer design. Additional analyses of the flyer design comments revealed four sub-themes: negative thoughts about the image, positive thoughts about the image, misunderstanding breast cancer risk information, and social comparison. Exploratory analyses controlling for message type indicated that image appraisal predicted PI such that those who commented on the image found the flyer to be less informative.
DISCUSSION


Results suggest that the flyer was informative but did not impact young women's breast cancer risk perceptions. Additionally, the image may have distracted young women from the intended message. Evaluating the acceptability of images used in health promotion materials is recommended before testing the effectiveness of the intervention.",2017,"Exploratory analyses controlling for message type indicated that image appraisal predicted PI such that those who commented on the image found the flyer to be less informative.
","['Young adult women (N = 123', 'young adult women']","['health promotion flyer', 'five health promotion flyers online and then completed measures of perceived breast cancer risk (PR) and perceived informativeness (PI) and a qualitative thought-listing activity']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",[],123.0,0.0112689,"Exploratory analyses controlling for message type indicated that image appraisal predicted PI such that those who commented on the image found the flyer to be less informative.
","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Bernat', 'Affiliation': 'a School of Nursing , Indiana University Purdue University Indianapolis , Indianapolis , IN , USA.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Hullmann', 'Affiliation': 'a School of Nursing , Indiana University Purdue University Indianapolis , Indianapolis , IN , USA.'}, {'ForeName': 'Glenn G', 'Initials': 'GG', 'LastName': 'Sparks', 'Affiliation': 'b Brian Lamb School of Communication , Purdue University , West Lafayette , IN , USA.'}]",Journal of psychosocial oncology,['10.1080/07347332.2016.1277821']
861,32000093,Acceptance and commitment therapy to reduce eating disorder symptoms and body image problems in patients with residual eating disorder symptoms: A randomized controlled trial.,"Body image problems are central aspects of eating disorders (ED), and risk factors both for the development of and relapse into an ED. Acceptance and commitment therapy (ACT) aims at helping patients accept uncomfortable internal experiences while committing to behaviors in accordance with life values. The aim of the present study was to compare the effectiveness of a group intervention, consisting of 12 sessions, based on ACT to treatment as usual (TAU) for patients with residual ED symptoms and body image problems. The study was a randomized controlled superiority trial. Patients with residual ED symptoms and body image problems were recruited from a specialized ED clinic in Sweden. The final sample consisted of 99 women, randomized to ACT or TAU. At the two-year follow-up, patients who received ACT showed a significant greater reduction in ED symptoms and body image problems and received less specialized ED care than patients in TAU. In conclusion, ACT was superior in reducing ED symptoms and body image problems.",2020,"At the two-year follow-up, patients who received ACT showed a significant greater reduction in ED symptoms and body image problems and received less specialized ED care than patients in TAU.","['patients with residual eating disorder symptoms', 'Patients with residual ED symptoms and body image problems were recruited from a specialized ED clinic in Sweden', 'patients with residual ED symptoms and body image problems']","['ACT', 'Acceptance and commitment therapy (ACT', 'Acceptance and commitment therapy', 'ACT or TAU']","['eating disorder symptoms and body image problems', 'ED symptoms and body image problems']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",99.0,0.139721,"At the two-year follow-up, patients who received ACT showed a significant greater reduction in ED symptoms and body image problems and received less specialized ED care than patients in TAU.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fogelkvist', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, SE 701 82 Örebro, Sweden. Electronic address: maria.fogelkvist@regionorebrolan.se.'}, {'ForeName': 'Sanna Aila', 'Initials': 'SA', 'LastName': 'Gustafsson', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, SE 701 82 Örebro, Sweden. Electronic address: sanna.aila-gustafsson@regionorebrolan.se.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kjellin', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, SE 701 82 Örebro, Sweden. Electronic address: lars.kjellin@regionorebrolan.se.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parling', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, The Centre for Psychotherapy, Education & Research, Liljeholmstorget 7, SE-117 63 Stockholm, Sweden. Electronic address: thomas.parling@ki.se.'}]",Body image,['10.1016/j.bodyim.2020.01.002']
862,32492153,VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population.,"CONTEXT


It is unclear whether vitamin D supplementation reduces risk of falls, and results from randomized controlled trials (RCTs) are conflicting.
OBJECTIVE


The objective of this work is to determine whether 2000 IU/day of supplemental vitamin D3 decreases fall risk.
DESIGN


VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT including 25 871 adults, randomly assigned November 2011 to March 2014 and treated for 5.3 years (median).
SETTING


This is a nationwide study.
PARTICIPANTS


Men 50 years or older and women 55 years or older (mean age, 67.1 years) without cancer or cardiovascular disease at baseline participated in this study.
INTERVENTIONS


Interventions included vitamin D3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (1 g/day) or respective placebos in a 2 × 2 factorial design.
MAIN OUTCOME MEASURES


Main outcome measures include 2 or more falls and falls resulting in a doctor or hospital visit.
RESULTS


Baseline serum total 25-hydroxyvitamin D (25[OH]D) level was 77 nmol/L; characteristics were well-balanced between groups. Numbers of participants with 2 or more falls were similar between active and placebo groups (9.8% vs 9.4%). Over 5 years, there were no differences in the proportion having 2 or more falls (odds ratio [OR] = 0.97; 95% CI, 0.90-1.05, P = .50), falls resulting in a doctor visit (OR = 1.03; 95% CI, 0.94-1.13, P = .46), or resulting in a hospital visit (OR = 1.04; 95% CI, 0.90-1.19, P = .61) between groups. Results did not differ between those with baseline 25(OH)D less than 50 vs 50 nmol/L or greater or other cut points.
CONCLUSION


Daily supplemental vitamin D3 vs placebo did not decrease fall risk in generally healthy adults not selected for vitamin D insufficiency. This large RCT does not indicate that supplemental vitamin D should be used for primary prevention of falls in the US population.",2020,Results did not differ between those with baseline 25(OH)D,"['Men ≥50 and women ≥55 years (mean age 67.1 years) without cancer or cardiovascular disease at baseline', 'Nationwide study', '25,871 adults, randomized November 2011-March 2014 and treated for 5.3 years (median', 'generally healthy adults']","['vitamin D3 vs. placebo', 'supplemental vitamin D3', 'VITamin D and OmegA-3 TriaL (VITAL', 'placebo-controlled RCT', 'VITamin D and OmegA-3 TriaL', 'Vitamin D3 (cholecalciferol; 2,000 IU/day', 'Vitamin D Supplements', 'and/or omega-3 fatty acids (1 g/day) or respective placebos', 'vitamin D supplementation', 'placebo']","['proportion having ≥2 falls', 'falls resulting in a doctor visit', 'Risk of Falls', 'Baseline serum total 25-hydroxyvitamin D [25(OH)D] level', 'fall risk', 'falls, falls resulting in a doctor or hospital visit']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",25871.0,0.702356,Results did not differ between those with baseline 25(OH)D,"[{'ForeName': 'Meryl S', 'Initials': 'MS', 'LastName': 'LeBoff', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Elle M', 'Initials': 'EM', 'LastName': 'Murata', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Cawthon', 'Affiliation': 'California Pacific Medical Center, Research Institute, University of California, San Francisco, California.'}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': 'Chou', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Massachusetts.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kotler', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa311']
863,28027625,Early Conversion From Calcineurin Inhibitor- to Everolimus-Based Therapy Following Kidney Transplantation: Results of the Randomized ELEVATE Trial.,"In a 24-month, multicenter, open-label, randomized trial, 715 de novo kidney transplant recipients were randomized at 10-14 weeks to convert to everolimus (n = 359) or remain on standard calcineurin inhibitor (CNI) therapy (n = 356; 231 tacrolimus; 125 cyclosporine), all with mycophenolic acid and steroids. The primary endpoint, change in estimated glomerular filtration rate (eGFR) from randomization to month 12, was similar for everolimus versus CNI: mean (standard error) 0.3(1.5) mL/min/1.73 2  versus -1.5(1.5) mL/min/1.73 2  (p = 0.116). Biopsy-proven acute rejection (BPAR) at month 12 was more frequent under everolimus versus CNI overall (9.7% vs. 4.8%, p = 0.014) and versus tacrolimus-treated patients (2.6%, p < 0.001) but similar to cyclosporine-treated patients (8.8%, p = 0.755). Reporting on de novo donor-specific antibodies (DSA) was limited but suggested more frequent anti-HLA Class I DSA under everolimus. Change in left ventricular mass index was similar. Discontinuation due to adverse events was more frequent with everolimus (23.6%) versus CNI (8.4%). In conclusion, conversion to everolimus at 10-14 weeks posttransplant was associated with renal function similar to that with standard therapy overall. Rates of BPAR were low in all groups, but lower with tacrolimus than everolimus.",2017,"Biopsy-proven acute rejection (BPAR) at month 12 was more frequent under everolimus versus CNI overall (9.7% vs. 4.8%, p = 0.014) and versus tacrolimus-treated patients (2.6%, p < 0.001) but similar to cyclosporine-treated patients (8.8%, p = 0.755).",['715 de novo kidney transplant recipients'],"['cyclosporine', 'mycophenolic acid and steroids', ' mL/min/1.73 2  versus -1.5(1.5', 'Calcineurin', 'Kidney Transplantation', 'Inhibitor- to Everolimus-Based Therapy', 'everolimus (n = 359) or remain on standard calcineurin inhibitor (CNI) therapy (n = 356; 231 tacrolimus; 125 cyclosporine']","['adverse events', 'estimated glomerular filtration rate (eGFR', 'Biopsy-proven acute rejection (BPAR', 'renal function', 'Rates of BPAR']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0054450', 'cui_str': 'Protein Phosphatase-2B'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3811844'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",715.0,0.0639808,"Biopsy-proven acute rejection (BPAR) at month 12 was more frequent under everolimus versus CNI overall (9.7% vs. 4.8%, p = 0.014) and versus tacrolimus-treated patients (2.6%, p < 0.001) but similar to cyclosporine-treated patients (8.8%, p = 0.755).","[{'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'de Fijter', 'Affiliation': 'Department of Nephrology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Holdaas', 'Affiliation': 'Section of Nephrology, Department of Transplant Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Øyen', 'Affiliation': 'Section of Transplant Surgery, Department of Transplant Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'J-S', 'Initials': 'JS', 'LastName': 'Sanders', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sundar', 'Affiliation': 'Department of Nephrology, Columbia Asia Hospitals, Malleshwaram West, Bangalore, India.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Bemelman', 'Affiliation': 'Department of Nephrology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sommerer', 'Affiliation': 'Department of Nephrology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pascual', 'Affiliation': 'Department of Nephrology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Avihingsanon', 'Affiliation': 'Faculty of Medicine, Chulalongkorn University and Excellent Center of Organ Transplantation, King Chulalongkorn Memorial Hospital, Patumwan, Bangkok, Thailand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pongskul', 'Affiliation': 'Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Oppenheimer', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Toselli', 'Affiliation': 'Kidney, Liver and Pancreas Transplant Unit, CRAI Norte, Ministry of Health, Buenos Aires, Argentina.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Russ', 'Affiliation': 'University of Adelaide and Central and Northern Adelaide Renal and Transplant Service, Royal Adelaide Hospital, North Terrace, Adelaide, Australia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Biometrics and Statistical Science, Novartis Pharmaceuticals, East Hanover, NJ.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Research and Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kochuparampil', 'Affiliation': 'Research and Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Cruzado', 'Affiliation': ""Department of Nephrology, University Hospital of Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van der Giet', 'Affiliation': 'Department of Nephrology, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.14186']
864,32412960,Omega-3 fatty acid therapy for cardiovascular disease: justified or not?,"PURPOSE OF REVIEW


To discuss the current evidence regarding the relationship between omega-3 fatty acid intake and atherosclerotic cardiovascular disease (ASCVD) risk.
RECENT FINDINGS


Combined results from randomized controlled trials using low-dosage (≤1.8 g/day of ethyl esters) eicosapentaenoic acid (EPA) or EPA + docosahexaenoic acid (DHA) suggest a small benefit for reducing coronary heart disease risk. The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality. Several national organizations have recommended IPE for ASCVD risk reduction in populations aligning with REDUCE-IT; the Food and Drug Administration has approved IPE for ASCVD risk reduction. However, the Outcomes Study to Assess Statin Residual Risk Reduction with Epanova (EPA + DHA carboxylic acids) in High Cardiovascular Risk Patients with Hypertriglyceridemia was recently stopped for futility.
SUMMARY


At present, the best available evidence for a role of omega-3 fatty acids in ASCVD risk reduction is for 4 g/day of IPE, as an adjunct to statin therapy, for patients with ASCVD or diabetes mellitus and elevated triglycerides.",2020,"The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality.","['High Cardiovascular Risk Patients with Hypertriglyceridemia', 'patients with ASCVD or diabetes mellitus and elevated triglycerides']","['ethyl esters) eicosapentaenoic acid (EPA) or EPA + docosahexaenoic acid (DHA', 'Epanova (EPA + DHA carboxylic acids', 'omega-3 fatty acids', 'Omega-3 fatty acid therapy']","['Reduction of Cardiovascular Events', 'cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4026303', 'cui_str': 'Epanova'}, {'cui': 'C0007066', 'cui_str': 'Carboxylic acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}]",,0.0504947,"The Reduction of Cardiovascular Events with EPA-Intervention Trial (REDUCE-IT) that administered 4 g/day icosapent ethyl (IPE) to individuals on statin at high or very high ASCVD risk with elevated triglycerides demonstrated a 25% relative risk reduction in the composite primary endpoint (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization and unstable angina) for IPE vs. placebo, and a lower hazard for all prespecified individual endpoints other than total mortality.","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, Boca Raton, Florida.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, Boca Raton, Florida.'}]",Current opinion in cardiology,['10.1097/HCO.0000000000000741']
865,31568890,The efficacy of maxillary and mandibular nerve blockade using electrical nerve stimulation for guidance.,"BACKGROUND


In oral and maxillofacial surgical procedures, sometimes conventional loco-regional anesthesia techniques could be insufficient in daily clinical practice. The aim of this study was to evaluate the efficacy of analgesia using electrical nerve stimulation (ENS) for maxillary or mandibular nerve blockade, in comparison with conventional loco-regional anesthesia techniques.
METHODS


The study comprised 52 patients who were attending the department for advanced surgery of the upper and lower jaw. Patients were randomly divided into 2 groups: ENS and Local group. The predictor variable was the anesthesia technique (ENS and Local groups). The outcome variables were patient assessed pain levels (VAS scores) and total anesthetic dose.
RESULTS


Both the administered anesthetic dose and patient-assessed pain levels were significantly lower in the ENS group than in the Local group, despite there being no difference in age, sex or any hemodynamic parameters between the groups.
CONCLUSIONS


Maxillary and mandibular nerve blockade is more efficient with ENS guidance, with lower amounts of anesthetic required, compared to conventional loco-regional anesthesia.",2020,"Both the administered anesthetic dose and patient-assessed pain levels were significantly lower in the ENS group than in the Local group, despite there being no difference in age, sex or any hemodynamic parameters between the groups.
",['52 patients who were attending the department for advanced surgery of the upper and lower jaw'],"['analgesia using electrical nerve stimulation (ENS', 'Maxillary and Mandibular Nerve Blockade Using Electrical Nerve Stimulation', 'ENS and Local group']","['pain levels', 'pain levels (VAS scores) and total anesthetic dose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0460026', 'cui_str': 'Mandibular region'}]","[{'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0024695', 'cui_str': 'Mandibular Nerve'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",52.0,0.0331612,"Both the administered anesthetic dose and patient-assessed pain levels were significantly lower in the ENS group than in the Local group, despite there being no difference in age, sex or any hemodynamic parameters between the groups.
","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Bayramoğlu', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ataturk University, Erzurum, Turkey. Electronic address: zeynep0569@hotmail.com.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Yavuz', 'Affiliation': 'Private Practice, Oral and Maxillofacial Surgery, Bursa, Turkey. Electronic address: mselimyavuz@gmail.com.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2019.09.007']
866,31320597,A Randomized Double-Blind Placebo-Controlled Phase II Trial of Dendritic Cell Vaccine ICT-107 in Newly Diagnosed Patients with Glioblastoma.,"PURPOSE


To evaluate the results of the randomized, double-blind, placebo-controlled phase II clinical trial of ICT-107 in patients with newly diagnosed glioblastoma.
PATIENTS AND METHODS


We conducted a double-blinded randomized phase II trial of ICT-107 in newly diagnosed patients with glioblastoma (GBM) and tested efficacy, safety, quality of life (QoL), and immune response. HLA-A1 +  and/or -A2 + -resected patients with residual tumor ≤1 cm 3  received radiotherapy and concurrent temozolomide. Following completion of radiotherapy, 124 patients, randomized 2:1, received ICT-107 [autologous dendritic cells (DC) pulsed with six synthetic peptide epitopes targeting GBM tumor/stem cell-associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL13Rα2] or matching control (unpulsed DC). Patients received induction ICT-107 or control weekly × 4 followed by 12 months of adjuvant temozolomide. Maintenance vaccinations occurred at 1, 3, and 6 months and every 6 months thereafter.
RESULTS


ICT-107 was well tolerated, with no difference in adverse events between the treatment and control groups. The primary endpoint, median overall survival (OS), favored ICT-107 by 2.0 months in the intent-to-treat (ITT) population but was not statistically significant. Progression-free survival (PFS) in the ITT population was significantly increased in the ICT-107 cohort by 2.2 months ( P  = 0.011). The frequency of HLA-A2 primary tumor antigen expression was higher than that for HLA-A1 patients, and HLA-A2 patients had higher immune response (via Elispot). HLA-A2 patients achieved a meaningful therapeutic benefit with ICT-107, in both the MGMT methylated and unmethylated prespecified subgroups, whereas only HLA-A1 methylated patients had an OS benefit.
CONCLUSIONS


PFS was significantly improved in ICT-107-treated patients with maintenance of QoL. Patients in the HLA-A2 subgroup showed increased ICT-107 activity clinically and immunologically.",2019,"The primary endpoint, median overall survival (OS), favored ICT-107 by 2.0 months in the intent-to-treat (ITT) population but was not statistically significant.","['Newly Diagnosed Patients with Glioblastoma', 'newly diagnosed patients with glioblastoma (GBM', 'patients with residual tumor ≤1 cm 3  received']","['HLA-A1 +  and/or -A2 + -resected', 'induction ICT-107 or control weekly × 4 followed by 12 months of adjuvant temozolomide', 'ICT-107 [autologous dendritic cells (DC) pulsed with six synthetic peptide epitopes targeting GBM tumor/stem cell-associated antigens MAGE-1, HER-2, AIM-2, TRP-2, gp100, and IL13Rα2] or matching control (unpulsed DC', 'ICT-107', 'Placebo', 'Dendritic Cell Vaccine ICT-107', 'radiotherapy and concurrent temozolomide']","['Maintenance vaccinations', 'frequency of HLA-A2 primary tumor antigen expression', 'median overall survival (OS), favored ICT-107', 'PFS', 'adverse events', 'ICT-107 activity', 'Progression-free survival (PFS', 'efficacy, safety, quality of life (QoL), and immune response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumor'}]","[{'cui': 'C0019731', 'cui_str': 'HLA-A1'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0003316', 'cui_str': 'Antigenic Determinants'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0019733', 'cui_str': 'HLA-A2'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0041361', 'cui_str': 'Tumor Antigens'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034380'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",124.0,0.427401,"The primary endpoint, median overall survival (OS), favored ICT-107 by 2.0 months in the intent-to-treat (ITT) population but was not statistically significant.","[{'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Center For Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts. pwen@partners.org.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': 'Center For Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Terri S', 'Initials': 'TS', 'LastName': 'Armstrong', 'Affiliation': 'Neuro-Oncology Branch, NCI, Bethesda, Maryland.'}, {'ForeName': 'Surasak', 'Initials': 'S', 'LastName': 'Phuphanich', 'Affiliation': 'Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Aiken', 'Affiliation': 'Rutgers-Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Landolfi', 'Affiliation': 'New Jersey Neuroscience Institute, Edison, New Jersey.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Curry', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jay-Jiguang', 'Initials': 'JJ', 'LastName': 'Zhu', 'Affiliation': 'University of Texas Health Sciences Center at Houston (UTHealth), Houston, Texas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Glantz', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Peereboom', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Markert', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'LaRocca', 'Affiliation': 'Norton Cancer Institute, Louisville, Kentucky.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': ""O'Rourke"", 'Affiliation': 'Raymond and Ruth Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Fink', 'Affiliation': 'Baylor Scott and White Neuro-Oncology Associates, Dallas, Texas.'}, {'ForeName': 'Lyndon', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gruber', 'Affiliation': 'New York University, New York, New York.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Lesser', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Pan', 'Affiliation': 'University of Texas, Southwest Medical Center, Dallas, Texas.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Kesari', 'Affiliation': 'John Wayne Cancer Institute and Pacific Neuroscience Institute, Santa Monica, California.'}, {'ForeName': 'Alona', 'Initials': 'A', 'LastName': 'Muzikansky', 'Affiliation': 'Alona Muzikansky, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Clemencia', 'Initials': 'C', 'LastName': 'Pinilla', 'Affiliation': 'Torrey Pines Institute for Molecular Studies, Port St. Lucie, Florida.'}, {'ForeName': 'Radleigh G', 'Initials': 'RG', 'LastName': 'Santos', 'Affiliation': 'Torrey Pines Institute for Molecular Studies, Port St. Lucie, Florida.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Yu', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0261']
867,31807943,Does helping mothers in multigenerational ADHD also help children in the long run? 2-year follow-up from baseline of the AIMAC randomized controlled multicentre trial.,"ADHD often affects multiple generations in a family. Previous studies suggested that children with ADHD benefit less from therapy if parents are also affected, since ADHD symptoms interfere with treatment implementation. This two-group randomised controlled trial examined whether targeting maternal ADHD boosts the efficacy of parent-child training (PCT) for the child's ADHD. Here, we report follow-up results 2 years from baseline. Mothers of 144 mother-child dyads (ADHD according to DSM-IV) were examined for eligibility (T1) and randomised to 12 weeks of intensive multimodal treatment comprising pharmacotherapy and DBT-based cognitive behavioural group psychotherapy (TG, n = 77) or clinical management comprising non-specific counselling (CG, n = 67) for Step 1 (concluded by T2). Subsequently, all dyads participated in 12 weekly PCT sessions for Step 2 (concluded by T3). In Step 3, participants received maintenance treatments for 6 months (concluded by T4). At 24 months after baseline (T5), we performed follow-up assessments. The primary endpoint was child ADHD/ODD score (observer blind rating). Outcomes at T5 were evaluated using ANCOVA. Assessments from 101 children and 95 mothers were available at T5. Adjusted means (m) of ADHD/ODD symptoms (range 0-26) in children did not differ between TG and CG (mean difference = 1.0; 95% CI 1.2-3.1). The maternal advantage of TG over CG on the CAARS-O:L ADHD index (range 0-36) disappeared at T5 (mean difference = 0.2; 95% CI - 2.3 to 2.6). Sensitivity analyses controlling for medication and significant predictors of follow-up participation showed unchanged outcomes. Within-group outcomes remained improved from baseline. At the 24-month follow-up, TG and CG converged. The superiority of intensive treatment regarding maternal symptoms disappeared. In general, cross-generational treatment seems to be effective in the long term. (BMBF grant 01GV0605; registration ISRCTN73911400).",2020,Adjusted means (m) of ADHD/ODD symptoms (range 0-26) in children did not differ between TG and CG (mean difference = 1.0; 95% CI 1.2-3.1).,"['101 children and 95 mothers', 'Mothers of 144 mother-child dyads (ADHD according to DSM-IV']","['parent-child training (PCT', 'intensive multimodal treatment comprising pharmacotherapy and DBT-based cognitive behavioural group psychotherapy (TG, n\u2009=\u200977) or clinical management comprising non-specific counselling (CG, n\u2009=\u200967) for Step 1 (concluded by T2']","['Adjusted means (m) of ADHD/ODD symptoms', 'child ADHD/ODD score (observer blind rating']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C0009429', 'cui_str': 'Multimodal Treatment'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033971', 'cui_str': 'Group Psychotherapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1301776', 'cui_str': 'Step 1'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]",144.0,0.156423,Adjusted means (m) of ADHD/ODD symptoms (range 0-26) in children did not differ between TG and CG (mean difference = 1.0; 95% CI 1.2-3.1).,"[{'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Geissler', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany. Geissler_J@ukw.de.'}, {'ForeName': 'Timo D', 'Initials': 'TD', 'LastName': 'Vloet', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Strom', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Jaite', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Graf', 'Affiliation': 'Institute of Medical Biometry and Statistics, Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Kappel', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Warnke', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jacob', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Medius Clinic, Kirchheim, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hennighausen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Haack-Dees', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Schneider-Momm', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Matthies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rösler', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Faculty of Medicine, Saarland University, Homburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Retz', 'Affiliation': 'Institute for Forensic Psychology and Psychiatry, Faculty of Medicine, Saarland University, Homburg, Germany.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Hänig', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Faculty of Medicine, Saarland University Hospital, Homburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'von Gontard', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Faculty of Medicine, Saarland University Hospital, Homburg, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Sobanski', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Alm', 'Affiliation': 'Clinic for Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hohmann', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Luise', 'Initials': 'L', 'LastName': 'Poustka', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Centre Göttingen, Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Colla', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Universitätsmedizin Rostock, Rostock, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gentschow', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Freitag', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Häge', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Holtmann', 'Affiliation': 'Hospital for Child and Adolescent Psychiatry, LWL University Hospital Hamm of the Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': 'Clinic for Child and Adolescent Psychiatry and Psychotherapy, Central Institute for Mental Health Mannheim, Mannheim, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jans', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01451-0']
868,32492354,Rationale and Design of ORCHID: A Randomized Placebo-controlled Clinical Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19.,"The ORCHID (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with coronavirus disease (COVID-19). This document provides the rationale and background for the trial and highlights key design features. We discuss five novel challenges to the design and conduct of a large, multicenter, randomized trial during a pandemic, including  1 ) widespread, off-label use of the study drug before the availability of safety and efficacy data;  2 ) the need to adapt traditional procedures for documentation of informed consent during an infectious pandemic;  3 ) developing a flexible and robust Bayesian analysis incorporating significant uncertainty about the disease, outcomes, and treatment;  4 ) obtaining indistinguishable drug and placebo without delaying enrollment; and  5 ) rapidly obtaining administrative and regulatory approvals. Our goals in describing how the ORCHID trial progressed from study conception to enrollment of the first patient in 15 days are to inform the development of other high-quality, multicenter trials targeting COVID-19. We describe lessons learned to improve the efficiency of future clinical trials, particularly in the setting of pandemics. The ORCHID trial will provide high-quality, clinically relevant data on the safety and efficacy of hydroxychloroquine for the treatment of COVID-19 among hospitalized adults.Clinical trial registered with www.clinicaltrials.gov (NCT04332991).",2020,"The Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with COVID-19.","['patients with symptomatic Disease (ORCHID) trial', 'hospitalized adults', 'adults hospitalized with COVID-19', 'Adults Hospitalized with COVID-19']","['Placebo', 'ORCHID', 'hydroxychloroquine', 'Hydroxychloroquine', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.277733,"The Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with COVID-19.","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, and.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Aggarwal', 'Affiliation': 'Division of Lung Diseases, National Heart, Lung and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Brower', 'Affiliation': 'Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Steven Y', 'Initials': 'SY', 'LastName': 'Chang', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eppensteiner', 'Affiliation': 'Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Filbin', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gibbs', 'Affiliation': 'Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'Department of Emergency Medicine and.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Gong', 'Affiliation': 'Division of Epidemiology and Population Health, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, New York City, New York.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Harrell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Hayden', 'Affiliation': 'Department of Medicine, and.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Harborview Medical Center, and.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University School of Medicine, Portland, Oregon.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Leither', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center and University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Cathryn F', 'Initials': 'CF', 'LastName': 'Oldmixon', 'Affiliation': 'Department of Medicine, and.'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lora A', 'Initials': 'LA', 'LastName': 'Reineck', 'Affiliation': 'Division of Lung Diseases, National Heart, Lung and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Ringwood', 'Affiliation': 'Department of Medicine, and.'}, {'ForeName': 'Bryce R H', 'Initials': 'BRH', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, University of Washington, Seattle, Washington.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Medicine, and.'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Shapiro', 'Affiliation': 'Department of Emergency Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Steingrub', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield, Massachusetts.'}, {'ForeName': 'Donna K', 'Initials': 'DK', 'LastName': 'Torr', 'Affiliation': 'Department of Pharmacy Services, Vanderbilt University Medical Center, Nashville, Tennessee; and.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weissman', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Brown', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center and University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, and.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202005-478SD']
869,31566573,Outcomes of rotational atherectomy versus modified balloon angioplasty in severely calcified coronary lesions based on target lesion location: a post hoc analysis of the PREPARE-CALC randomised trial.,,2020,,['severely calcified coronary lesions'],['rotational atherectomy versus modified balloon angioplasty prior to drug-eluting stent implantation'],[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0162655', 'cui_str': 'Rotational Atherectomy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",[],,0.0860408,,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Rheude', 'Affiliation': 'Deutsches Herzzentrum, Munich, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Toelg', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Byrne', 'Affiliation': ''}, {'ForeName': 'Abdelhakim', 'Initials': 'A', 'LastName': 'Allali', 'Affiliation': ''}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wiebe', 'Affiliation': ''}, {'ForeName': 'Dmitriy S', 'Initials': 'DS', 'LastName': 'Sulimov', 'Affiliation': ''}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Voll', 'Affiliation': ''}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': ''}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': ''}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00488']
870,32416432,Effects of an exercise intervention for patients with advanced inoperable lung cancer undergoing chemotherapy: A randomized clinical trial.,"OBJECTIVE


Exercise can improve treatment-related side effects, quality of life, and function in patients with various types of cancer; however, more evidence is needed for patients with advanced inoperable lung cancer.
MATERIAL AND METHODS


We randomized 218 patients with advanced inoperable lung cancer to a 12-week supervised, structured exercise training program (aerobic, strength, and relaxation training) twice weekly versus usual care. Primary outcome was change in maximal oxygen uptake (VO 2  peak). Secondary outcomes were muscle strength, functional capacity, forced expiratory volume in 1 s, health-related quality of life, anxiety, and depression.
RESULTS


There was no significant difference between the intervention and control groups in VO 2  peak. There was a significant improvement in muscle strength. There was also a significant difference between the two for social well-being (Functional Assessment of Cancer Therapy-Lung, FACT-L), anxiety, and depression.
CONCLUSION


There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care. There was a significant difference between the groups for social well-being. The primary outcome did not show a significant improvement in VO 2  peak. Based on our results, future patients with advanced inoperable lung cancer should be considered for supervised exercise during the course of their disease.",2020,There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care.,"['patients with various types of cancer', 'patients with advanced inoperable lung cancer', '218 patients with advanced inoperable lung cancer', 'patients with advanced inoperable lung cancer undergoing']","['chemotherapy', 'exercise intervention', 'structured exercise training program (aerobic, strength, and relaxation training) twice weekly versus usual care']","['muscle strength outcomes', 'social well-being (Functional Assessment of Cancer Therapy-Lung, FACT-L), anxiety, and depression', 'VO 2  peak', 'level of anxiety and depression', 'maximal oxygen uptake (VO 2  peak', 'muscle strength', 'muscle strength, functional capacity, forced expiratory volume in 1\u2009s, health-related quality of life, anxiety, and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C4517647', 'cui_str': '218'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",218.0,0.0758603,There was a significant reduction in the level of anxiety and depression and a significant increase in all muscle strength outcomes in the intervention group compared to patients randomized to usual care.,"[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark. Electronic address: morten.quist@regionh.dk.'}, {'ForeName': 'Seppo W', 'Initials': 'SW', 'LastName': 'Langer', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark.'}, {'ForeName': 'Lærke', 'Initials': 'L', 'LastName': 'Winther', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark.'}, {'ForeName': 'Jørgen H', 'Initials': 'JH', 'LastName': 'Laursen', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Karl B', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rørth', 'Affiliation': 'Department of Oncology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Adamsen', 'Affiliation': 'University Hospitals Centre for Health Research Department, Rigshospitalet, University of Copenhagen, 9701 Denmark; Department of Public Health, University of Copenhagen, Denmark.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.003']
871,27328484,A prospective comparison of outcome following cryopreservation using vitrification vs. a modified slow-freeze protocol of 2 pronuclear (2PN) and day 3 multi-cell embryos.,"PURPOSE


To compare the efficacy of vitrification of 2 pronuclear and day 3 cleavage stage embryo vs. a modified slow freeze protocol that historically has achieved good survival and pregnancy rates at these stages.
MATERIALS AND METHODS


Embryos were randomly assigned by day to freezing at the 2 proncular stage or day 3 cleavage stage embryos by either vitrification or a modified slow freeze protocol. Comparisons were made for survival rate, cleaveage rate, and pregnancy rate.
RESULTS


The results were comparable with a slight edge to vitrification. Only the implantation rates of day 3 cleavage staged embryos (75% vs. 30.4%) showed a significant difference.
CONCLUSIONS


Vitrification seems to be equally or possibly slightly superior to freezing embryos at the 2 pronuclear or day 3 cleavage stage vs. a modified slow freeze protocol that had been previously found to be superior to the slow freeze method of LaSalle-Testart.",2016,"Only the implantation rates of day 3 cleavage staged embryos (75% vs. 30.4%) showed a significant difference.
",['Embryos were randomly assigned by day to freezing at the 2 proncular stage or day 3 cleavage stage embryos by either'],"['cryopreservation using vitrification vs. a modified slow-freeze protocol of 2 pronuclear (2PN) and day 3 multi-cell embryos', 'vitrification or a modified slow freeze protocol']","['implantation rates of day 3 cleavage staged embryos', 'good survival and pregnancy rates', 'survival rate, cleaveage rate, and pregnancy rate']","[{'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0010405', 'cui_str': 'Cryofixation'}, {'cui': 'C2936610', 'cui_str': 'Glass-Liquid Transition'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0414601,"Only the implantation rates of day 3 cleavage staged embryos (75% vs. 30.4%) showed a significant difference.
","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Summers', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Check', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Choe', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
872,27416930,Postpartum depressive symptoms and maternal sensitivity: an exploration of possible social media-based measures.,"This study examined the relationship between self-reported depressive symptoms, directly observed maternal sensitivity, and the content and themes of pictures posted on a mobile application. Data on 20 participants were analyzed. Results suggested that mothers' scoring as more intrusive on the maternal sensitivity scale tended to post a higher proportion of photos of themselves interacting with their babies. An association between higher levels of maternal depressive symptoms and a lower proportion of posts of baby smiling photos was also suggested.",2017,Results suggested that mothers' scoring as more intrusive on the maternal sensitivity scale tended to post a higher proportion of photos of themselves interacting with their babies.,['20 participants were analyzed'],[],"['maternal sensitivity scale', 'Postpartum depressive symptoms and maternal sensitivity', 'maternal depressive symptoms']",[],[],"[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",20.0,0.0257842,Results suggested that mothers' scoring as more intrusive on the maternal sensitivity scale tended to post a higher proportion of photos of themselves interacting with their babies.,"[{'ForeName': 'Ana Luísa B T', 'Initials': 'ALBT', 'LastName': 'Dáu', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Callinan', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Mayes', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Megan V', 'Initials': 'MV', 'LastName': 'Smith', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, CT, USA. megan.smith@yale.edu.'}]",Archives of women's mental health,['10.1007/s00737-016-0650-4']
873,27328486,"Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study.","PURPOSE OF INVESTIGATION


To compare the effects of desogestrel (DSG) 150 mcg/ethinyl estradiol (EE) 20 mcg for 21 days followed by either seven days of EE ten mcg (21/7-active) or no treatment (DSG/EE+no Tx) on hemostatic markers.
MATERIALS AND METHODS


This was a randomized, multicenter, open-label study that enrolled healthy premenopausal women. Non-inferiority of 21/7-active to DSG/EE+no Tx was determined if the upper limit of the two-sided 95% CI of the mean treatment difference in prothrombin fragment 1+2 (F1+2) over 24 weeks between groups was < 130 pmol/L.
RESULTS


246 subjects (n = 125, 21/7-active; n = 121, DSG/EE+no Tx) comprised the primary analysis. Mean F1+2 levels increased in both 21/7-active and DSG/EE+no Tx regimens (least square [LS] mean changes +45 pmol/L and +56.8 pmol/L, respectively). LS mean treatment difference was -11.8 pmol/L (95% CI: -54.8, 31.2).
CONCLUSION


The effect of adding EE ten mcg to the seven-day hormone-free interval of DSG/EE on F1+2 levels was non-inferior to traditional DSG/EE.",2016,"Mean F1+2 levels increased in both 21/7-active and DSG/EE+no Tx regimens (least square [LS] mean changes +45 pmol/L and +56.8 pmol/L, respectively).",['enrolled healthy premenopausal women'],"['desogestrel-containing combined oral contraceptive regimens', 'desogestrel (DSG) 150 mcg/ethinyl estradiol (EE', 'EE ten mcg (21/7-active) or no treatment (DSG/EE+no Tx']","['Hemostatic effects', 'Mean F1+2 levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0009906', 'cui_str': 'Contraceptive Agents, Female, Combined'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",246.0,0.0693399,"Mean F1+2 levels increased in both 21/7-active and DSG/EE+no Tx regimens (least square [LS] mean changes +45 pmol/L and +56.8 pmol/L, respectively).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ricciotti', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hsieh', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Howard', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Weiss', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
874,27328489,Effect of mifepristone in the different treatments of endometriosis.,"OBJECTIVE


To observe the effect of small-dose mifepristone conservative treatment and laparoscopic combined with mifepristone in the treatment of endometriosis.
MATERIALS AND METHODS


Sixty-five endometriosis cases were given small-dose mifepristone conservative treatment and were assessed for the effect of this treatment; 92 cases were randomly divided into control group (taking gestrinone) and observation group (mifepristone), FSH, P, PRL and E2 levels were compared before and after treatment, and pregnancy investigation and each sex hormone level monitoring were followed-up at one year after drug withdrawal.
RESULTS


Using mifepristone, FSH, P, E2, and LH levels all significantly changed six months after treatment and recovered 12 months after drug withdrawal; when comparing the pelvic symptoms, endometrial thickness showed that mifepristone was significantly effective (p < 0.01), and the pregnancy rate was 27.69%. Comparing the two groups, none of the total effective rate, pregnancy rate one year of follow-up, and recurrence rates were significantly different; hormone levels in the both groups were significantly decreased or increased (p < 0.05) after treatment. The two groups had no significant difference (p > 0.05), but 12 months after drug withdrawal, in the control group (not in the observation group), LH level was still significantly different (p < 0.05) compared pre-treatment.
CONCLUSIONS


In the conservative treatment, mifepristone can safely improve the hormone levels, reduce the thickness of the endometrium, alleviate symptoms. With laparoscopic minimally invasive combined drug therapy, mifepristone has a significant effect, with a more followed-up pregnancy rate, less recurrence, and no drug accumulation side-effects, hence it is worthy of clinical application.",2016,"Comparing the two groups, none of the total effective rate, pregnancy rate one year of follow-up, and recurrence rates were significantly different; hormone levels in the both groups were significantly decreased or increased (p < 0.05) after treatment.","['endometriosis', 'Sixty-five endometriosis cases']","['mifepristone conservative treatment and laparoscopic combined with mifepristone', 'mifepristone conservative treatment', 'control group (taking gestrinone) and observation group (mifepristone), FSH, P, PRL and E2 levels', 'mifepristone']","['FSH, P, E2, and LH levels', 'LH level', 'total effective rate, pregnancy rate one year of follow-up, and recurrence rates', 'pelvic symptoms, endometrial thickness', 'hormone levels', 'pregnancy rate', 'hormone levels, reduce the thickness of the endometrium, alleviate symptoms']","[{'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0017507', 'cui_str': 'Gestrinone'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}]",92.0,0.0504408,"Comparing the two groups, none of the total effective rate, pregnancy rate one year of follow-up, and recurrence rates were significantly different; hormone levels in the both groups were significantly decreased or increased (p < 0.05) after treatment.","[{'ForeName': 'Y X', 'Initials': 'YX', 'LastName': 'Zhang', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
875,31865423,n-3 PUFA and caloric restriction diet alters lipidomic profiles in obese men with metabolic syndrome: a preliminary open study.,"PURPOSE


For people with metabolic syndrome (MetS), altering the macronutrient composition of their diets might ameliorate metabolic abnormalities. The common method of clinical assessment only measures total lipid concentrations but ignores the individual species that contribute to these total concentrations. Thus, to predict the amelioration of MetS following caloric restriction (CR) and the intake of fish oil, we used lipidomics to investigate changes in plasma lipids and identify potential lipid metabolites.
METHODS


Lipidomics was performed using ultra-high-performance liquid chromatography-tandem mass spectrometry on plasma samples from a clinical trial conducted over 12 weeks. Subjects were randomized into two groups: CR (n = 12) and CR with fish oil (CRF, n = 9). Anthropometric and clinical parameters were measured and correlated with plasma lipidomics data.
RESULTS


Compared with baseline, significant differences were observed in body weight, waist circumference, blood pressure and interleukin-6 in both groups, but triglyceride (TG) levels significantly decreased in only the CRF group (all p < 0.05). A total of 138 lipid species were identified. Levels of species containing long-chain polyunsaturated fatty acids were significantly elevated-greater than twofold-following fish oil intake, these included TG (60:9) and phosphatidylcholine (p40:6) (all q < 0.05). TG (60:9) tended to correlate negatively with body weight, body mass index, blood pressure, and HbA1c following fish oil intake.
CONCLUSION


CR and fish oil can ameliorate MetS features, including anthropometric parameters, blood pressure, and blood lipid concentrations. The levels of particular lipid species such as TG-containing docosapentaenoic acid were elevated post-intervention and negatively associated with MetS features. TG (60:9) may be proposed as a lipid metabolite to predict amelioration in MetS following the intake of CR and fish oil.",2020,"Levels of species containing long-chain polyunsaturated fatty acids were significantly elevated-greater than twofold-following fish oil intake, these included TG (60:9) and phosphatidylcholine (p40:6) (all q < 0.05).","['obese men with metabolic syndrome', 'people with metabolic syndrome (MetS']","['ultra-high-performance liquid chromatography-tandem mass spectrometry', 'CR and fish oil', 'n-3 PUFA and caloric restriction diet', 'CR with fish oil (CRF', 'CRF']","['levels of particular lipid species such as TG-containing docosapentaenoic acid', 'body weight, waist circumference, blood pressure and interleukin-6', 'Levels of species containing long-chain polyunsaturated fatty acids', 'body weight, body mass index, blood pressure, and HbA1c following fish oil intake', 'anthropometric parameters, blood pressure, and blood lipid concentrations', 'triglyceride (TG) levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0008562', 'cui_str': 'Chromatography, High Speed Liquid'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid (C22:5 N3)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005768'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}]",,0.0532259,"Levels of species containing long-chain polyunsaturated fatty acids were significantly elevated-greater than twofold-following fish oil intake, these included TG (60:9) and phosphatidylcholine (p40:6) (all q < 0.05).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shabrina', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, 250 Wu-Xing Street, Taipei, 110, Taiwan.'}, {'ForeName': 'T-H', 'Initials': 'TH', 'LastName': 'Tung', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, 250 Wu-Xing Street, Taipei, 110, Taiwan.'}, {'ForeName': 'N T K', 'Initials': 'NTK', 'LastName': 'Nguyen', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, 250 Wu-Xing Street, Taipei, 110, Taiwan.'}, {'ForeName': 'H-C', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, 250 Wu-Xing Street, Taipei, 110, Taiwan.'}, {'ForeName': 'H-T', 'Initials': 'HT', 'LastName': 'Wu', 'Affiliation': 'Graduate Institute of Metabolism and Obesity Sciences, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Metabolism and Obesity Sciences, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'S-Y', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'School of Nutrition and Health Sciences, Taipei Medical University, 250 Wu-Xing Street, Taipei, 110, Taiwan. sihuang@tmu.edu.tw.'}]",European journal of nutrition,['10.1007/s00394-019-02149-4']
876,32026447,Relationship of White Matter Lesions with Intracerebral Hemorrhage Expansion and Functional Outcome: MISTIE II and CLEAR III.,"BACKGROUND/OBJECTIVE


Intracerebral hemorrhage (ICH) patients commonly have concomitant white matter lesions (WML) which may be associated with poor outcome. We studied if WML affects hematoma expansion (HE) and post-stroke functional outcome in a post hoc analysis of patients from randomized controlled trials.
METHODS


In ICH patients from the clinical trials MISTIE II and CLEAR III, WML grade on diagnostic computed tomography (dCT) scan (dCT, < 24 h after ictus) was assessed using the van Swieten scale (vSS, range 0-4). The primary outcome for HE was > 33% or > 6 mL ICH volume increase from dCT to the last pre-randomization CT (< 72 h of dCT). Secondary HE outcomes were: absolute ICH expansion, > 10.4 mL total clot volume increase, and a subgroup analysis including patients with dCT < 6 h after ictus using the primary HE definition of > 33% or > 6 mL ICH volume increase. Poor functional outcome was assessed at 180 days and defined as modified Rankin Scale (mRS) ≥ 4, with ordinal mRS as a secondary endpoint.
RESULTS


Of 635 patients, 55% had WML grade 1-4 at dCT (median 2.2 h from ictus) and 13% had subsequent HE. WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location. WML increased the odds for having poor functional outcome (mRS ≥ 4) in univariate analyses (vSS 4; OR 4.16; 95% CI 2.54-6.83; P < 0.001) which persisted in multivariable analyses after adjustment for HE and other outcome risk factors.
CONCLUSIONS


Concomitant WML does not increase the odds for HE in patients with ICH but increases the odds for poor functional outcome.
CLINICAL TRIAL REGISTRATION


http://www.clinicaltrials.gov trial-identifiers: NCT00224770 and NCT00784134.",2020,"WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location.",['patients with dCT'],['WML'],"['absolute ICH expansion, ', 'ICH volume, intraventricular hemorrhage volume, warfarin/INR\u2009>\u20091.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location', 'Poor functional outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",635.0,0.141451,"WML at dCT did not increase the odds for primary or secondary HE endpoints (P ≥ 0.05) after adjustment for ICH volume, intraventricular hemorrhage volume, warfarin/INR > 1.5, ictus to dCT time in hours, age, diabetes mellitus, and thalamic ICH location.","[{'ForeName': 'Björn M', 'Initials': 'BM', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ullman', 'Affiliation': ""Division of Neurology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA. nlullman@gmail.com.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Muschelli', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Norrving', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dlugash', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Avadhani', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Awad', 'Affiliation': 'Department of Neurosurgery, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zuccarello', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Ziai', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Lindgren', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurocritical care,['10.1007/s12028-020-00916-4']
877,27132416,Efficiency of GnRH analogues in treating large functional ovarian cysts.,"AIM


The aim of this study was to determine the potential therapeutic benefit of a single administration of a GnRH analogue in pre- menopausal women presenting large functional ovarian cysts (FOCs) (diameter > five cm).
MATERIALS AND METHODS


Fifty-one patients (median age 37.4 years) diagnosed with ovarian cysts, presumed benign based on transvaginal and/or transabdominal ultrasound, were divided in three study groups. Patients of group A received no medication whereas patients of groups B and C were treated with a single administration of a GnRH analogue and combined oral contraceptives, respectively. Patients were re-examined after a three-month period. Three of the 51 patients were lost in follow-up or stopped the treatment.
RESULTS


Complete resolution of the ovarian cysts was observed in eight (50%), 14 (70%), and eight (67%) patients of groups A, B, and C, respectively. No side effects were observed in either of the three groups. The positive therapeutic effect in group B did not reach statistical significance compared with the two other groups (p > 0.05).
CONCLUSION


Anew option of treating large FOCS through a single-dose of a GnRH analogue is proposed and should be carefully considered. Further research is needed in order to evaluate GnRH analogues as an alternative treatment.",2016,"The positive therapeutic effect in group B did not reach statistical significance compared with the two other groups (p > 0.05).
","['pre- menopausal women presenting large functional ovarian cysts (FOCs) (diameter > five cm', 'Fifty-one patients (median age 37.4 years) diagnosed with ovarian cysts, presumed benign based on transvaginal and/or transabdominal ultrasound']","['GnRH analogue and combined oral contraceptives', 'GnRH analogue', 'GnRH analogues']","['positive therapeutic effect', 'Complete resolution of the ovarian cysts', 'side effects']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1142385', 'cui_str': 'Functional ovarian cyst'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517741', 'cui_str': '37.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029927', 'cui_str': 'Ovarian Cysts'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0009906', 'cui_str': 'Contraceptive Agents, Female, Combined'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1527144'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0029927', 'cui_str': 'Ovarian Cysts'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",51.0,0.034654,"The positive therapeutic effect in group B did not reach statistical significance compared with the two other groups (p > 0.05).
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zervoudis', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Iatrakis', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tomara', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bothou', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Peitsidis', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mastorakos', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
878,32419349,Prophylactic Foley catheter insertion into defunctioning ileostomy to reduce obstruction after colorectal surgery: pilot randomized controlled trial.,"BACKGROUND


Defunctioning ileostomies provide faecal diversion in major colorectal surgery. This reduces the consequences of an anastomotic leak. However, the formation of an ileostomy carries risks including obstruction at the level of the fascia. Post-operative oedema at the level of the fascia may contribute to obstruction. We hypothesize that the prophylactic insertion of a Foley catheter into the afferent limb of a defunctioning loop ileostomy may help decompress and improve time to low-residue diet (LRD). The objective of the study was to assess the feasibility of a Foley catheter, prophylactically inserted into the afferent limb of a defunctioning loop ileostomy, after major colorectal surgery.
METHODS


The study was a prospective pilot-randomized controlled trial. Ethical approval was obtained from Northern B Health and Disability Ethics Committee 15/NTB/91 ANZCTR Trial ID: ACTRN12615000691549.
RESULTS


Forty-nine patients undergoing major elective colorectal surgery with a defunctioning ileostomy, between the years of 2015 and 2018 at North Shore Hospital, Auckland, New Zealand were included in this study. Patients were randomly allocated to either the Foley catheter (n = 26) or non-Foley catheter (n = 23) group. The median time taken to tolerate LRD the primary outcome, was 2 days in the Foley group versus 2 days in the non-Foley group (P = 0.05). There were no differences in the secondary outcome measures such as time to stoma output, length of stay or complications.
CONCLUSION


This trial failed to show a statistical difference in time taken to tolerate a LRD residue in the Foley catheter group. There was no difference in length of stay, time to flatus or stoma output.",2020,This trial failed to show a statistical difference in time taken to tolerate a LRD residue in the Foley catheter group.,"['major colorectal surgery', 'Forty-nine patients undergoing major elective colorectal surgery with a defunctioning ileostomy, between the years of 2015 and 2018 at North Shore Hospital, Auckland, New Zealand were included in this study']","['Foley catheter, prophylactically inserted into the afferent limb of a defunctioning loop ileostomy', 'Prophylactic Foley catheter insertion into defunctioning ileostomy', 'Foley catheter (n =\u200926) or non-Foley catheter']","['time to stoma output, length of stay or complications', 'median time taken to tolerate LRD', 'length of stay, time to flatus or stoma output']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0023985', 'cui_str': 'Creation of continent ileostomy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0425404', 'cui_str': 'Low residue diet'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",49.0,0.195566,This trial failed to show a statistical difference in time taken to tolerate a LRD residue in the Foley catheter group.,"[{'ForeName': 'Suheelan', 'Initials': 'S', 'LastName': 'Kulasegaran', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Nisbet', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Vasey', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Bacil', 'Initials': 'B', 'LastName': 'Otutaha', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': 'Planning, Funding and Outcomes, Waitemata and Auckland District Health Boards, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jarvis', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Mike H', 'Initials': 'MH', 'LastName': 'Moir', 'Affiliation': 'Department of Surgery, North Shore Hospital, Waitemata District Health Board, Auckland, New Zealand.'}]",ANZ journal of surgery,['10.1111/ans.15714']
879,31545681,"Effect of Transdermal Testosterone and Oral Progesterone on Drug-Induced QT Interval Lengthening in Older Men: A Randomized, Double-Blind, Placebo-Controlled Crossover-Design Study.",,2019,,['Older Men'],"['Placebo', 'Transdermal Testosterone and Oral Progesterone']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]",[],,0.332368,,"[{'ForeName': 'Elena Tomaselli', 'Initials': 'ET', 'LastName': 'Muensterman', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jaynes', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Sowinski', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Overholser', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (C.S.).'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Kovacs', 'Affiliation': 'Krannert Institute of Cardiology (R.J.K.), School of Medicine, Indiana University, Indianapolis.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Tisdale', 'Affiliation': 'College of Pharmacy, Purdue University, Indianapolis, IN (E.T.M., H.A.J., K.M.S., B.R.O., J.E.T.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041395']
880,27132415,Effects of piroxicam administration on pregnancy outcome in intrauterine insemination (IUI) cycles: a randomized clinical trial.,"BACKGROUND


Uterus contractibility is considered a powerful prognostic factor in predicting the embryo transfer outcome. Moreover, uterine contractions are known to be stimulated by prostaglandins which are produced by cyclooxygenase from arachidonic acid. As such, suppressing the inflammatory response and contractions using anti-inflammatory and relaxant agents is expected to result in increased success rate of embryo transfer and artificial insemination.
OBJECTIVE


To investigate the effect of piroxicam administration on the success rate in intrauterine insemination (IU) cycles in patients presenting with unexplained infertility.
MATERIALS AND METHODS


This randomized, placebo-controlled clinical trial included 260 women with unexplained infertility undergoing IUI cycles. Patients were randomly assigned to receive either piroxicam ten mg/day on days 4-6 after IUI or placebo (control group). The main outcome measures were number of IUI cycles, pregnancy, abortion, and multiple pregnancy rates.
RESULTS


The pregnancy rate was found to be 25 (19.2%) and 16 (12.3%) in piroxicam and control groups, respectively (p = 0.039). Five patients (3.8%) in piroxicam group experienced twin pregnancy whereas only three patients (2.3%) in control group had twin pregnancy (p = 0.361). The pregnancy rate per cycle was also significantly higher in those who received piroxicam as compared to controls (11.16 vs. 6.66; p = 0.021).
CONCLUSION


Administration of piroxicam after IUI is associated with decreased number of cycles, as well as increased pregnancy rate and pregnancy rate per cycle in IUI cycles. However, piroxicam did not have any effect on abortion, multiple pregnancy, and ongoing pregnancy rates.",2016,"However, piroxicam did not have any effect on abortion, multiple pregnancy, and ongoing pregnancy rates.","['260 women with unexplained infertility undergoing IUI cycles', 'patients presenting with unexplained infertility', 'intrauterine insemination (IUI) cycles']","['piroxicam', 'placebo']","['number of IUI cycles, pregnancy, abortion, and multiple pregnancy rates', 'pregnancy rate per cycle', 'pregnancy rate and pregnancy rate', 'pregnancy outcome', 'abortion, multiple pregnancy, and ongoing pregnancy rates', 'twin pregnancy', 'pregnancy rate']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}]","[{'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0152150', 'cui_str': 'Pregnancy, Twin'}]",260.0,0.358285,"However, piroxicam did not have any effect on abortion, multiple pregnancy, and ongoing pregnancy rates.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zarei', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mahboubi', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Parsanezhad', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Alborzi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Younesi', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Madadi', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
881,26753485,The safety and acceptability of intravenous fentanyl versus intramuscular pethidine for pain relief during labour.,"OBJECTIVES


This trial aimed to ascertain the relative efficacy, adverse effects, and acceptability of fentanyl versus pethidine for pain relief during labour.
MATERIALS AND METHODS


Parturients (n=80) in the active phase who requested analgesia were randomly assigned to receive either intravenous fentanyl (n=40) or intramuscular pethidine (n=40). Pain scores hourly, maternal and fetal adverse effects, neonatal outcome, and maternal acceptability were assessed.
RESULTS


Pain scores decreased in both groups, the decrease varying from mild to moderate, average pain scores remaining above 3.5 in both groups. Pain scores returned towards baseline over time; three hours after the initiation of treatment in the fentanyl group. Pethidine was associated with more maternal nausea and vomiting (p < 0.05) while fentanyl was associated with more neonates with low Apgar scores at one minute and more need for neonatal resuscitation and naloxone administration when compared to pethidine (p < 0.05). Both drugs were acceptable for pain relief during labour.
CONCLUSION


Fentanyl is comparable to pethidine for pain relief during labour regarding efficacy and acceptability, but with more neonates with low Apgar scores at one minute and higher need for neonatal resuscitation and naloxone administration. Further larger trials are needed to confirm its safety.",2015,Pethidine was associated with more maternal nausea and vomiting (p < 0.05) while fentanyl was associated with more neonates with low Apgar scores at one minute and more need for neonatal resuscitation and naloxone administration when compared to pethidine (p < 0.05).,"['Parturients (n=80) in the active phase who requested analgesia', 'pain relief during labour']","['Fentanyl', 'Pethidine', 'pethidine', 'intramuscular pethidine', 'intravenous fentanyl', 'fentanyl']","['average pain scores', 'safety and acceptability', 'pain relief', 'Pain scores hourly, maternal and fetal adverse effects, neonatal outcome, and maternal acceptability', 'Pain scores', 'maternal nausea and vomiting']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}]",,0.170381,Pethidine was associated with more maternal nausea and vomiting (p < 0.05) while fentanyl was associated with more neonates with low Apgar scores at one minute and more need for neonatal resuscitation and naloxone administration when compared to pethidine (p < 0.05).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rezk', 'Affiliation': ''}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'El-Shamy', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Massod', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dawood', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Habeeb', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
882,26748736,A tool to predict suicidal ideation and behavior in bipolar disorder: The Concise Health Risk Tracking Self-Report.,"BACKGROUND


Few brief, self-report measures exist that can reliably predict adverse suicidality outcomes in patients with BD. This study utilized the Concise Health Risk Tracking Self-Report (CHRT) to assess suicidality in patients with BD and examined its psychometric performance, clinical correlates, and prospective value in predicting adverse events related to suicidality.
METHODS


The CHRT was administered at baseline and follow-up to 482 adult patients in Bipolar CHOICE, a 6-month randomized comparative effectiveness trial. The Columbia Suicide Severity Rating Scale (CSSRS) was used at baseline to assess lifetime history of suicide attempts and related behaviors. Clinician-rated measures of mood (Bipolar Inventory of Symptoms Scale) and bipolar symptoms (Clinical Global Impressions-Bipolar Version) were conducted at baseline and follow-up.
RESULTS


The CHRT showed excellent internal consistency and construct validity and was highly correlated with clinician ratings of depression, anxiety, and overall functioning at baseline and throughout the study. Baseline CHRT scores significantly predicted risk of subsequent suicidality-related Serious Adverse Events (sSAEs), after controlling for mood and comorbidity. Specifically, the hazard of a sSAE increased by 76% for every 10-point increase in baseline CHRT score. Past history of suicide attempts and related behaviors, as assessed by the CSSRS, did not predict subsequent sSAEs.
LIMITATIONS


The CSSRS was used to assess static risk factors in terms of past suicidal behaviors and may have been a more powerful predictor over longer-term follow-up.
CONCLUSIONS


The CHRT offers a quick and robust self-report tool for assessing suicidal risk and has important implications for future research and clinical practice.",2016,The CHRT offers a quick and robust self-report tool for assessing suicidal risk and has important implications for future research and clinical practice.,"['patients with BD', 'bipolar disorder', '482 adult patients in Bipolar CHOICE']","['Concise Health Risk Tracking Self-Report (CHRT', 'CHRT']","['hazard of a sSAE', 'suicidal ideation and behavior', 'Columbia Suicide Severity Rating Scale (CSSRS', 'clinician ratings of depression, anxiety, and overall functioning', 'Clinician-rated measures of mood (Bipolar Inventory of Symptoms Scale) and bipolar symptoms (Clinical Global Impressions-Bipolar Version', 'baseline CHRT score', 'adverse suicidality outcomes', 'excellent internal consistency and construct validity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",482.0,0.0328868,The CHRT offers a quick and robust self-report tool for assessing suicidal risk and has important implications for future research and clinical practice.,"[{'ForeName': 'Noreen A', 'Initials': 'NA', 'LastName': 'Reilly-Harrington', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: nharrington11@mgh.harvard.edu.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Kamali', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Dustin J', 'Initials': 'DJ', 'LastName': 'Rabideau', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Leah W', 'Initials': 'LW', 'LastName': 'Shesler', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, OH, USA; Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bowden', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Terence A', 'Initials': 'TA', 'LastName': 'Ketter', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': ""Bipolar Disorders Research Center, University Hospital's Case Medical Center, Case Western Reserve University, Cleveland, OH, USA.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Bobo', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry, University of New Mexico, Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kocsis', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Gold', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Finkelstein', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Kinrys', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2015.12.036']
883,26753490,Interleukin-6 and C-reactive protein levels in the amniotic fluid as indicators of preterm delivery in Turkish women.,"OBJECTIVE


The aim of this study was to determine the value of amniotic fluid interleukin-6 (IL-6) and C-reactive protein (CRP) levels in the prediction of preterm delivery in singleton pregnancies without any known risk factors for preterm delivery in Turkish women.
MATERIALS AND METHODS


Patients in the present perinatology department who underwent mid-trimester genetic amniocentesis due to evidence of increased risk of aneuploidy in their prenatal serum screening tests were included in the study. A sample of amniotic fluid from each patient was assessed for IL-6 and CRP. Concentrations of IL-6 and CRP in the amniotic fluid of preterm delivery and term delivery groups were compared.
RESULTS


Of 151 singleton pregnancies, 142 participants were included in the study. The participants were assigned to either the preterm or term delivery group based on pregnancy outcome. IL-6 levels in the amniotic fluid were significantly higher in the preterm delivery group, and there was a statistically significant negative correlation between IL-6 concentrations in the amniotic fluid and gestational age at delivery (correlation coefficient (CC): -18.5%, p < 0.05). A negative correlation was also detected between CRP levels in the amniotic fluid and gestational age at delivery, but the correlation was not statistically significant (p = 0.068).
CONCLUSION


Measuring IL-6 in the amniotic fluid can identify women at risk of preterm delivery. Because it is not acceptable to perform amniocentesis for this screening, it is more convenient for patients in whom genetic amniocentesis is performed.",2015,"IL-6 levels in the amniotic fluid were significantly higher in the preterm delivery group, and there was a statistically significant negative correlation between IL-6 concentrations in the amniotic fluid and gestational age at delivery (correlation coefficient (CC): -18.5%, p < 0.05).","['Turkish women', 'singleton pregnancies without any known risk factors for preterm delivery in Turkish women', 'Patients in the present perinatology department who underwent mid-trimester genetic amniocentesis due to evidence of increased risk of aneuploidy in their prenatal serum screening tests were included in the study', '151 singleton pregnancies', '142 participants were included in the study']",[],"['amniotic fluid interleukin-6 (IL-6) and C-reactive protein (CRP) levels', 'IL-6 concentrations', 'IL-6 levels', 'Interleukin-6 and C-reactive protein levels', 'IL-6 and CRP', 'Concentrations of IL-6 and CRP', 'CRP levels']","[{'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0031063', 'cui_str': 'Perinatology'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0032982', 'cui_str': 'Pregnancy Trimesters'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0002627', 'cui_str': 'Amniocentesis'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0002938', 'cui_str': 'Aneuploid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0002638', 'cui_str': 'Amniotic Fluid'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",142.0,0.253833,"IL-6 levels in the amniotic fluid were significantly higher in the preterm delivery group, and there was a statistically significant negative correlation between IL-6 concentrations in the amniotic fluid and gestational age at delivery (correlation coefficient (CC): -18.5%, p < 0.05).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Öz', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Polat', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Özgü', 'Affiliation': ''}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Seçkin', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Taşin', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Danişman', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
884,31547752,"Agitation, Oxidative Stress, and Cytokines in Alzheimer Disease: Biomarker Analyses From a Clinical Trial With Nabilone for Agitation.","The endocannabinoid system has been a target of interest for agitation in Alzheimer disease (AD) because of potential behavioral effects and its potential impact on mechanisms implicated in AD such as oxidative stress (OS) and neuroinflammation. We explored whether serum markers of OS and neuroinflammation were associated with response to the cannabinoid nabilone in agitated patients with AD (N = 38). All participants were enrolled in a 14-week, double-blind, cross-over trial comparing nabilone to placebo (6 weeks each) with a 1-week washout between phases. Samples were collected at the start and end of each phase. The cross-sectional relationship agitation (Cohen Mansfield Agitation Inventory) and OS and inflammatory markers were investigated to select markers of interest. Significant markers were then explored for their relationship with response. The OS marker, 4-hydroxynonenal (4-HNE;  F 1, 35  = 6.41,  P  = .016), and the proinflammatory cytokine, tumor necrosis factor-α (TNF-α;  F 1, 29  = 3.97,  P  = .06), were associated with agitation severity, and TNF-α remained significantly associated ( F 2, 25  = 3.69,  P  = .04) after adjustment for cognition. In the placebo phase, lower baseline 4-HNE was associated with decreases in agitation severity only (b = 0.01,  P  = .01), while lower baseline TNF-α was associated with decreases in agitation severity in the nabilone phase only (b = 1.14,  P  = .045). Changes in 4-HNE were not associated with changes in agitation severity in either phase. In the nabilone phase, lower baseline TNF-α was associated with decreases in agitation severity (b = 1.14,  P  = .045), and decreases in TNF-α were associated with decreases in agitation severity (b = 1.12,  P  = .006). These findings suggest that OS and neuroinflammation may be associated with agitation severity, while nabilone may have anti-inflammatory effects.",2020,"In the placebo phase, lower baseline 4-HNE was associated with decreases in agitation severity only (b = 0.01,  P  = .01), while lower baseline TNF-α was associated with decreases in agitation severity in the nabilone phase only (b = 1.14,  P  = .045).","['Alzheimer Disease', 'agitated patients with AD (N = 38']",['placebo'],"['TNF-α', 'agitation severity', 'Agitation, Oxidative Stress, and Cytokines', 'agitation severity, and TNF-α', 'serum markers of OS and neuroinflammation', 'proinflammatory cytokine, tumor necrosis factor-α']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}]",,0.190073,"In the placebo phase, lower baseline 4-HNE was associated with decreases in agitation severity only (b = 0.01,  P  = .01), while lower baseline TNF-α was associated with decreases in agitation severity in the nabilone phase only (b = 1.14,  P  = .045).","[{'ForeName': 'Myuri', 'Initials': 'M', 'LastName': 'Ruthirakuhan', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Andreazza', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicolaas Paul L G', 'Initials': 'NPLG', 'LastName': 'Verhoeff', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Black', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Lanctôt', 'Affiliation': 'Hurvitz Brain Sciences Research Program, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988719874118']
885,26524798,Effect of taking a one time injection of one mg leuprolide acetate three days after embryo transfer on pregnancy outcome and level of first beta human chorionic gonadotropin (beta-hCG) level.,"PURPOSE


To determine if the injection of a gonadotropin releasing hormone agonist (GnRHa) three days after embryo transfer will improve pregnancy and implantation rates.
MATERIALS AND METHODS


One mg s.c. of leuprolide acetate was randomly given based on patient decision three days after embryo transfer to some patients undergoing in vitro fertilization-embryo transfer (IVF-ET).
RESULTS


For women aged ≤ 43 the clinical pregnancy rate for those not taking the GnRHa was 39.5% (68/122) vs. 54.5% (42/77) for those taking leuprolide acetate (Chi-square, p = 0.0275). The respective implantation rates were 22.6% vs. 30.2% (p = 0.0495). There was no difference in first serum beta human chorionic gonadotropin (beta-hCG) levels according to whether leuprolide was used or not.
CONCLUSIONS


Leuprolide acetate similar to other GnRH agonists can improve implantation rates following IVF-ET when injected once in mid-luteal phase. The beneficial effect may be on GnRH receptors in the endometrium rather than the embryo (which had been hypothesized to direct increased placental production of hCG).",2015,The respective implantation rates were 22.6% vs. 30.2% (p = 0.0495).,['patients undergoing in vitro fertilization-embryo transfer (IVF-ET'],"['Leuprolide acetate', 'leuprolide', 'leuprolide acetate', 'gonadotropin releasing hormone agonist (GnRHa']","['clinical pregnancy rate', 'pregnancy outcome and level of first beta human chorionic gonadotropin (beta-hCG) level', 'respective implantation rates', 'implantation rates', 'first serum beta human chorionic gonadotropin (beta-hCG) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]","[{'cui': 'C0700596', 'cui_str': 'Leuprolide Acetate'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0106132', 'cui_str': 'Chorionic Gonadotropin, beta Polypeptide, Human'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0500629,The respective implantation rates were 22.6% vs. 30.2% (p = 0.0495).,"[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Check', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Choe', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Summers-Chase', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
886,26524801,Assessment of follicular and serum VEGF and IGF-1 in ICSI patients: hMG vs rFSH.,"PURPOSE


To investigate the effect of recombinant follicular stimulating hormone (r-FSH) and human menopausal gonadotropin (hMG) on follicular microenvironment via assessment of follicular and serum vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) levels in intracytoplasmic sperm injection (ICSI) cycles.
MATERIALS AND METHODS


Designed as a prospective cohort study. Twenty-five patients underwent controlled ovarian hyperstimulation (COH) with r-FSH and 20 patients underwent with hMG.
RESULTS


Both groups were comparable regarding the women's mean age and body mass index (BMI). The amount of VEGF (pg/ml) in serum and follicular fluid in the group I and II were comparable (275 ± 135.3 vs 330.7 ± 190.0; p > 0.05 and 2,081.1 ± 1095.1 vs 1,971.1 ± 975.6; p > 0.05, respectively). The amount of IGF-1 (ng/ml) in serum and follicular fluid in the group I and II were also comparable (225.3 ± 69.3 vs 204.1 ± 56.3, p > 0.05 and 176.1 ± 67.2 vs 185.8 ± 48.7, p > 0.05, respectively). Pregnancy rates were also comparable between groups.
CONCLUSIONS


The hMG and r-FSH in COH produced comparable follicular microenvironment regarding follicular VEGF and IGF-l.",2015,"I and II were comparable (275 ± 135.3 vs 330.7 ± 190.0; p > 0.05 and 2,081.1 ± 1095.1 vs 1,971.1 ± 975.6; p > 0.05, respectively).","['ICSI patients', 'Twenty-five patients underwent controlled ovarian hyperstimulation (COH) with r-FSH and 20 patients underwent with hMG']","['recombinant follicular stimulating hormone (r-FSH) and human menopausal gonadotropin (hMG', 'COH']","['Pregnancy rates', 'Assessment of follicular and serum VEGF and IGF-1', 'follicular microenvironment via assessment of follicular and serum vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) levels']","[{'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C3160882', 'cui_str': 'Controlled ovarian hyperstimulation'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}]","[{'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",25.0,0.0695942,"I and II were comparable (275 ± 135.3 vs 330.7 ± 190.0; p > 0.05 and 2,081.1 ± 1095.1 vs 1,971.1 ± 975.6; p > 0.05, respectively).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bilge', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ozdemirci', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Esinler', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Karahanoglu', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Esinler', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Aksu', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
887,26524818,Ultrasound-guided intrauterine insemination versus blind intrauterine insemination: a randomized controlled trial.,"PURPOSE


This study was performed to determine the effects of ultrasound (US) guidance during intrauterine insemination (IUI) on pregnancy rate.
MATERIALS AND METHODS


This study is a prospective randomized controlled trial which was performed in Women's Health Research and Education Hospital, Infertility Unit. The study enrolled 130 couples who were scheduled to undergo IUI. The couples were randomized according to a computer-generated list into two groups; 1) the ultrasound-guided IUI group included 64 couples (n = 64) treated for 99 cycles 2) blind IUI group included 66 couples (n = 66) treated for 104 cycles. All women underwent controlled ovarian stimulation before IUI. The study's main measurements were pregnancy rate per cycle; pregnancy rate per woman.
RESULTS


The pregnancy rates were similar in both the ultrasound-guided (USG) (16.2%, 16/99) and non-ultrasound-guided (NUSG)(12.5%, 13/104) groups (p = 0.386).
CONCLUSIONS


The present results suggest a routine ultrasound guidance during IUI is not essential as it does not increase pregnancy rates but it can be used in such cases to overwhelm some sort of difficulties.",2015,The present results suggest a routine ultrasound guidance during IUI is not essential as it does not increase pregnancy rates but it can be used in such cases to overwhelm some sort of difficulties.,"['group included 64 couples (n = 64) treated for 99 cycles 2) blind IUI group included 66 couples (n = 66) treated for 104 cycles', ""Women's Health Research and Education Hospital, Infertility Unit"", '130 couples who were scheduled to undergo IUI']","['ultrasound-guided IUI', 'ultrasound (US) guidance', 'Ultrasound-guided intrauterine insemination versus blind intrauterine insemination']","['pregnancy rates', 'pregnancy rate per cycle; pregnancy rate per woman']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0035168'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",130.0,0.0542683,The present results suggest a routine ultrasound guidance during IUI is not essential as it does not increase pregnancy rates but it can be used in such cases to overwhelm some sort of difficulties.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Polat', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ekiz', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Yildirim', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Sahin', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ulker', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Alkis', 'Affiliation': ''}, {'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Tekirdag', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
888,26321750,Counselees' Expressed Level of Understanding of the Risk Estimate and Surveillance Recommendation are Not Associated with Breast Cancer Surveillance Adherence.,"We studied counselees' expressed understanding of the risk estimate and surveillance recommendation in the final consultation for breast cancer genetic counseling in relation with their risk perception, worry and cancer surveillance adherence 1 year post-counseling. Consecutive counselees were included from 2008 to 2010. Counselees with an indication for diagnostic DNA-testing for themselves or a breast cancer affected relative were requested to complete online questionnaires before and after counseling and one year after counseling (N = 152-124). Self-reported surveillance was compared to surveillance recommendations. Consultations were videotaped. Counselees' reactions to the risks and recommendations were coded. Statements about the risk perception and surveillance intentions of breast cancer unaffected counselees were transcribed. Associations with outcomes were explored. Almost all breast cancer unaffected counselees (>90 %) reacted to their risk estimate with an utterance indicating understanding and this reaction was not significantly associated with their post-visit risk perception alignment. Over one-third (38.6 %) overestimated their risk post-counseling. Few counselees (5.8 %) expressed surveillance intentions. One year after counseling, about three-quarters (74.0 %) of the breast cancer unaffected counselees had adhered to the surveillance recommendation. Almost one-quarter (23.3 %) had performed more mammograms/MRI scans than recommended, which was associated with prior mammography uptake (n = 47; X (2)  = 5.2; p = .02). Counselees' post-counseling overestimation of their risk, high levels of worry and high surveillance uptake were not reflected in their reactions to the counselor's information during the final visit.",2016,"Counselees' post-counseling overestimation of their risk, high levels of worry and high surveillance uptake were not reflected in their reactions to the counselor's information during the final visit.",['Consecutive counselees were included from 2008 to 2010'],[],[],"[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],[],,0.0155105,"Counselees' post-counseling overestimation of their risk, high levels of worry and high surveillance uptake were not reflected in their reactions to the counselor's information during the final visit.","[{'ForeName': 'Akke', 'Initials': 'A', 'LastName': 'Albada', 'Affiliation': 'Department of Medical Genetics, University Medical Centre Utrecht, Utrecht, The Netherlands. a.albada@umcutrecht.nl.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'van Dulmen', 'Affiliation': 'NIVEL (Netherlands Institute for Health Services Research, Utrecht, The Netherlands.'}, {'ForeName': 'Henrietta', 'Initials': 'H', 'LastName': 'Dijkstra', 'Affiliation': 'NIVEL (Netherlands Institute for Health Services Research, Utrecht, The Netherlands.'}, {'ForeName': 'Ivette', 'Initials': 'I', 'LastName': 'Wieffer', 'Affiliation': 'Department of Medical Genetics, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Arjen', 'Initials': 'A', 'LastName': 'Witkamp', 'Affiliation': 'Department of Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Margreet G E M', 'Initials': 'MG', 'LastName': 'Ausems', 'Affiliation': 'Department of Medical Genetics, University Medical Centre Utrecht, Utrecht, The Netherlands.'}]",Journal of genetic counseling,['10.1007/s10897-015-9869-x']
889,26738148,Evaluation of the Audio Bracelet for Blind Interaction for improving mobility and spatial cognition in early blind children - A pilot study.,"This study was designed to assess the effectiveness of the Audio Bracelet for Blind Interaction (ABBI) system for improving mobility and spatial cognition in visually impaired children. The bracelet is worn on the wrist and the key feature is to provide an audio feedback about body movements to help visually impaired children to build a sense of space. Nine early blind children took part at this study. The study lasted 12 weeks. Once per week each child participated in a 45-minutes ABBI rehabilitation with trained professionals. He also had to use it one hour per day at home alone or with one relative. The mobility and spatial cognition abilities were measured before and after a 12-weeks rehabilitation program with three different tests. Results showed that the use of the Audio Bracelet for Blind Interaction allowed the early blind children to significantly improve their mobility and spatial abilities. Although an extended study including a larger number of participants is needed to confirm these data, the present results are encouraging. They do suggest that ABBI could be used for rehabilitate the sense of space in visually impaired children.",2015,Results showed that the use of the Audio Bracelet for Blind Interaction allowed the early blind children to significantly improve their mobility and spatial abilities.,['visually impaired children'],[],"['mobility and spatial cognition abilities', 'mobility and spatial abilities', 'mobility and spatial cognition']","[{'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0679024', 'cui_str': 'Spatial Ability'}]",,0.0245766,Results showed that the use of the Audio Bracelet for Blind Interaction allowed the early blind children to significantly improve their mobility and spatial abilities.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Finocchietti', 'Affiliation': ''}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Cappagli', 'Affiliation': ''}, {'ForeName': 'Lope', 'Initials': 'L', 'LastName': 'Ben Porquis', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Baud-Bovy', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cocchi', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gori', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2015.7320248']
890,32419688,Dietary intake and processes of behaviour change in a nutrition education intervention for pregnant women in rural Malawi: a cluster-randomised controlled trial.,"OBJECTIVE


To examine if increased intake of locally available nutrient-dense foods among pregnant women improved the quality of their dietary intake and if use of the Theory of Planned Behaviour could explain changes in their dietary behaviour.
DESIGN


We used data from a randomised controlled trial where the intervention group received nutrition education and dietary counselling. We promoted the use of recipes that utilised powders to enhance dietary diversity. We examined how the intervention achieved changes in dietary intakes and used mixed effects logistic regression models with random effects at village level to explore changes over time of the outcomes, adjusted for selected explanatory variables.
SETTING


The study was conducted in twenty villages in rural Malawi.
PARTICIPANTS


Data from 257 pregnant women who were enrolled during late first trimester and followed until birth.
RESULTS


The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods. A third of the women in the intervention group attained optimal DDS, whereas about 50 % attained optimal SFG. The theorised behaviour mediators (i.e. nutrition attitudes, nutrition behaviour control and subjective norm) that had improved were also significantly associated with high DDS.
CONCLUSIONS


Improved dietary intakes were achieved through promoting the use of locally available nutrient-dense foods. Attainment of high DDS was a consequence of the women's belief in the effectiveness of the proposed nutrition recommendations. We identified critical personal and environmental constraints related to dietary intakes during pregnancy in a low-resource setting.",2020,"The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods.","['twenty villages in rural Malawi', 'Data from 257 pregnant women who were enrolled during late first trimester and followed until birth', 'pregnant women in rural Malawi', 'pregnant women']","['nutrition education and dietary counselling', 'nutrition education intervention']","['Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods', 'optimal DDS']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}]",257.0,0.0758828,"The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods.","[{'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Ziyenda Katenga-Kaunda', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}, {'ForeName': 'Per Ole', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Holmboe-Ottesen', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Fjeld', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ibrahimu', 'Initials': 'I', 'LastName': 'Mdala', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Penjani Rhoda', 'Initials': 'PR', 'LastName': 'Kamudoni', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}]",Public health nutrition,['10.1017/S1368980020000294']
891,30721109,Identifying change-dropout patterns during an Internet-based intervention for depression by applying the Muthen-Roy model.,"To date, only few studies have attempted to investigate non-ignorable dropout during Internet-based interventions by applying an NMAR model, which includes missing data indicators in its equations. Here, the Muthen-Roy model was used to investigate change and dropout patterns in a sample of patients with mild-to-moderate depression symptoms ( N  = 483) who were randomized to a 12-week Internet-based intervention (deprexis, identifier: NCT01636752). Participants completed the PHQ-9 biweekly during the treatment. We identified four change-dropout patterns: Participants showing high impairment, improvement and low dropout probability (C3,  N  = 134) had the highest rate of reliable change at 6- and 12-month follow-up. A further pattern was characterized by high impairment, deterioration and high dropout probability (C2,  N  = 32), another by low impairment, improvement and high dropout probability (C1,  N  = 198). The last pattern was characterized by high impairment, no change and low dropout probability (C4,  N  = 119). In addition to deterioration, also rapid improvement may lead to dropout as a result of a perceived ""good enough"" dosage of treatment. This knowledge may strengthen sensitivity for the mechanisms of dropout and help to consider its meaning in efforts to optimize treatment selection.",2020,"The last pattern was characterized by high impairment, no change and low dropout probability (C4, N = 119).",['patients with mild-to-moderate depression symptoms (N =\xa0483'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],483.0,0.0213193,"The last pattern was characterized by high impairment, no change and low dropout probability (C4, N = 119).","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Arndt', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Trier, Trier, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Lutz', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Trier, Trier, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Rubel', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Trier, Trier, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'GAIA AG, Hamburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Späth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Fuhr', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Eberhard Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Rose', 'Affiliation': 'Department of Psychosomatic Medicine, University Medical Center, Berlin, Germany.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Hohagen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Cognitive behaviour therapy,['10.1080/16506073.2018.1556331']
892,27132405,The effect of clomiphene citrate vs. letrozole on post-coital tests.,"PURPOSE


To determine if letrozole is less likely to create a hostile cervical mucus than clomiphene citrate.
MATERIALS AND METHODS


Post-coital testing compared at time of peak follicular maturation in women attaining mature follicles in first or second cycle of these two drugs. The study was randomized. Intercourse occurred at least 8-16 hours before.
RESULTS


Poor post-coital tests were found in twice the frequency in letrozole cycles than clomiphene citrate cycles.
CONCLUSIONS


Despite its shorter half-life, letrozole seems to be as least as likely, if not more, to adversely affect cervical mucus.",2016,"RESULTS


Poor post-coital tests were found in twice the frequency in letrozole cycles than clomiphene citrate cycles.
",['women attaining mature follicles in first or second cycle of these two drugs'],"['clomiphene citrate vs. letrozole', 'letrozole']",['Intercourse'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}]",,0.0188623,"RESULTS


Poor post-coital tests were found in twice the frequency in letrozole cycles than clomiphene citrate cycles.
","[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Check', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Liss', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vaniver', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
893,31550352,Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial.,"BACKGROUND


The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection.
OBJECTIVES


The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance.
METHODS


This was a Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL with 6-month follow-up.
RESULTS


Significantly greater least squares mean changes from baseline were associated with ASI treatment (N = 125) vs placebo (N = 59) for satisfaction with facial appearance at all visits until day 148 (5 months; P < 0.0001-0.0037), psychological well-being at all visits (P < 0.0001-0.0279), and aging appearance at all visits except day 148 (P < 0.0001-0.0409). Significant differences (ASI vs placebo) were observed at all visits for individual items: ""how rested your face looks"" (P < 0.0001-0.0415), ""I feel okay about myself"" (P = 0.0011-0.0399), and ""I feel attractive"" (P < 0.0001-0.0102). Maximal least squares mean (standard error) changes in aging appearance score were -1.4 (0.3; ASI) and -0.3 (0.4; placebo). Investigators' live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r = -0.41 and r = -0.36 [both P < 0.0001], respectively).
CONCLUSIONS


Significant improvements in patient satisfaction with aging, facial appearance, and, importantly, psychological well-being were demonstrated with ASI employing FACE-Q scales up to 5 to 6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice.
LEVEL OF EVIDENCE: 1


",2020,"At all visits there were significant differences (ASI vs placebo) for individual items: 'how rested your face looks' (p<0.0001-0.0415), 'I feel okay about myself' (p=0.0011-0.0399), and 'I feel attractive' (p<0.0001-0.0102).","['ASI 50 units in adults with moderate-to-severe GL, with 6-month follow-up']","['placebo', 'abobotulinumtoxinA (ASI, liquid-formulation']","['satisfaction with facial appearance', 'Patient Satisfaction', 'Maximal LS mean (standard error) changes in aging appearance score', 'patient satisfaction with aging and facial appearance', 'rested your face looks', 'FACE-Q facial appearance and psychological scales']","[{'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282631', 'cui_str': 'Facies'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0222045'}]",,0.167176,"At all visits there were significant differences (ASI vs placebo) for individual items: 'how rested your face looks' (p<0.0001-0.0415), 'I feel okay about myself' (p=0.0011-0.0399), and 'I feel attractive' (p<0.0001-0.0102).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ascher', 'Affiliation': 'Iena Plastic Surgery Clinic, Paris, France.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Rzany', 'Affiliation': 'Rzany and Hund, Berlin, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Kestemont', 'Affiliation': 'Mediti Centre, Antibes-Juan Les Pins, France.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Hilton', 'Affiliation': 'Dr. Hilton & Partner, Düsseldorf, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Heckmann', 'Affiliation': 'Starnberg Skin Centre, Starnberg, Germany.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Bodokh', 'Affiliation': 'Dermatology Department, Cannes Hospital, Cannes, France.'}, {'ForeName': 'Ernst Magnus', 'Initials': 'EM', 'LastName': 'Noah', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Red Cross Hospital, Kassel, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Boineau', 'Affiliation': 'Clinique Chirurgicale Bel-Air, Bordeaux, France.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kerscher', 'Affiliation': 'Division of Cosmetic Science, Department of Chemistry, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Volteau', 'Affiliation': 'Neurology Development, Ipsen Innovation, Les Ulis, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Le Berre', 'Affiliation': 'Neurology Development, Ipsen Innovation, Les Ulis, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Neurology Development, Ipsen Innovation, Les Ulis, Paris, France.'}]",Aesthetic surgery journal,['10.1093/asj/sjz248']
894,32100719,Collagen Therapy in Lumbar Spondylosis - a Pilot Study. Does the Route of Administration Matter?,"BACKGROUND


To compare the effectiveness of three techniques of collagen injection in the treatment of low back pain (LBP) in lumbar spondylosis.
MATERIAL AND METHODS


In this randomized prospective study, 30 patients with lumbar spondylosis were assigned to 3 groups: subcutaneous (Group A, n = 10), periradicular (Group B, n = 10) and epidural (Group C, n = 10). Collagen injections were administered once a week (4 injections in total). Assessment involved a visual pain scale (VAS) (0-10), Oswestry scale (0-50), Laitinen scale (0-16) and One Leg Stance Test (OLST) - time to onset of pain in the support limb. Patients were assessed at the start of treatment (W0), on completion of treatment (W1) and 1 month after completion of treatment (W2).
RESULTS


Improvement was seen with all three techniques of collagen administration. The minimal clinically important difference (MID) of 3 points on the VAS scale was noted in 44% of patients in Group A, 40% of patients in Group B and 60% of Group C. The MID for the Oswestry scale, determined at 10 points, was achieved in 56%, 50% and 20% of patients, respectively, while the MID for the Laitinen scale, determined at 4 points, was achieved in 56%, 30% and 40% of patients, respectively. All treated patients achieved the reference value of 30 seconds for OLST only in Group A.
CONCLUSION


Subcutaneous administration of collagen is not inferior in terms of effectiveness to periradicular and epidural injections in the treatment of LBP in lumbar spondylosis.",2019,Subcutaneous administration of collagen is not inferior in terms of effectiveness to periradicular and epidural injections in the treatment of LBP in lumbar spondylosis.,"['30 patients with lumbar spondylosis', 'lumbar spondylosis', 'low back pain (LBP) in lumbar spondylosis']","['collagen injection', 'OLST', 'Collagen injections', 'Collagen Therapy']","['VAS scale', 'visual pain scale (VAS) (0-10), Oswestry scale (0-50), Laitinen scale (0-16) and One Leg Stance Test (OLST) - time to onset of pain in the support limb']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149983', 'cui_str': 'Lumbar spondylosis (disorder)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0222045'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0429928', 'cui_str': 'Test time (observable entity)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]",30.0,0.0448414,Subcutaneous administration of collagen is not inferior in terms of effectiveness to periradicular and epidural injections in the treatment of LBP in lumbar spondylosis.,"[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Godek', 'Affiliation': 'Sutherland Medical Center, Warszawa, Polska / Sutherland Medical Center, Warsaw, Poland.'}]","Ortopedia, traumatologia, rehabilitacja",['10.5604/01.3001.0013.7400']
895,26737301,Comparing consumption oxygen during and after squat exercise in Smith Machine and whole-body vibration.,"Currently the physical exercise in whole body vibration platforms has become popular among people that frequenting gym and physiotherapy clinics. The objective of this study was to compare the oxygen consumption in the squat exercise performed at Smith Machine and squat performed on the vibration platform following the protocols usually referenced in both types of exercise (with load of 70% in the Smith Machine and unloaded on the vibration platform). The sample consisted of eight male subjects, with a mean age of 22.75 ± 2.05 years, an average body mass 74.50 ± 9.50kg, a stature of 1.79 ± 0.63m and estimated body fat percentage of 5.01 ± 0.94%. The volunteers performed two exercise sessions, one in the Smith Machine (AGSM) and the other on the vibration platform (AGPP). Each session consisted in 5 sets of 10 repetitions each, with a cadence of 40 beat.min(-1). The load used in the exercise AGSM performance was 70% of 1RM and in the AGPP was used a vibration frequency of 50 Hz, during 60 seconds in high amplitude. The order of the sections was randomized, with seven days apart. The AGPP session presented VO2 absolute = 0.95 ± 0.21L/min, VO2 relative = 12.86 ± 2.43ml/kg/min, and HR = 93.69 ± 10.55 beats/min; and the AGSM session presented VO2 absolute = 1.33 ± 0.29 L/min, VO2 relative = 17.91 ± 2.70 ml/kg/min, and HR = 120.69 ± 14.21 beats/min. The VO2 and HR values of the AGSM session were significantly higher than that found in AGPP session.",2015,"The AGPP session presented VO2 absolute = 0.95 ± 0.21L/min, VO2 relative = 12.86 ± 2.43ml/kg/min, and HR = 93.69 ± 10.55 beats/min; and the AGSM session presented VO2 absolute = 1.33 ± 0.29 L/min, VO2 relative = 17.91 ± 2.70 ml/kg/min, and HR = 120.69 ± 14.21 beats/min.","['eight male subjects, with a mean age of 22.75 ± 2.05 years, an average body mass 74.50 ± 9.50kg, a stature of 1.79 ± 0.63m and estimated body fat percentage of 5.01 ± 0.94']","['physical exercise', 'exercise sessions, one in the Smith Machine (AGSM) and the other on the vibration platform (AGPP', 'consumption oxygen during and after squat exercise in Smith Machine and whole-body vibration']","['oxygen consumption', 'VO2 and HR values of the AGSM session']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517468', 'cui_str': '0.63'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C4517487', 'cui_str': '0.94 (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}]","[{'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",8.0,0.0235591,"The AGPP session presented VO2 absolute = 0.95 ± 0.21L/min, VO2 relative = 12.86 ± 2.43ml/kg/min, and HR = 93.69 ± 10.55 beats/min; and the AGSM session presented VO2 absolute = 1.33 ± 0.29 L/min, VO2 relative = 17.91 ± 2.70 ml/kg/min, and HR = 120.69 ± 14.21 beats/min.","[{'ForeName': 'Ana C G', 'Initials': 'AC', 'LastName': 'Justo', 'Affiliation': ''}, {'ForeName': 'Francisco J F', 'Initials': 'FJ', 'LastName': 'Saavedra', 'Affiliation': ''}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Vilaca-Alves', 'Affiliation': ''}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Rosa', 'Affiliation': ''}, {'ForeName': 'Eduardo B', 'Initials': 'EB', 'LastName': 'Neves', 'Affiliation': ''}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Reis', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2015.7319401']
896,26737337,Comparison between the therapeutic effects of robotic-assisted locomotor training and an anti-spastic medication on spasticity.,"We studied the effects of robotic-assisted locomotor (LOKOMAT) training or an anti-spastic medication (tizanidine) on neuromuscular abnormality associated with spasticity in persons with incomplete Spinal Cord Injury (SCI). Subjects were randomly divided to three groups: Lok, Tiz, and Cont. LOKOMAT training was performed 3 days/week for 4 weeks, with up to 45 minutes of training per session. Tizanidine (2mg) was administered (4\day), for 4 weeks. Subjects in Cont group received no intervention. The participants were evaluated before and after 4 weeks of training, and the effects of training on the intrinsic (muscular) and reflexive components of the neuromuscular properties were quantified over the ankle range-of-motion. A parallel-cascade system identification technique was used to determine the reflex and intrinsic stiffness of the ankle joint as a function of ankle position at each time point. The intercept and slope of the stiffness vs. joint angle curve were then calculated and tracked over the four-week period. The number of subjects that achieved the minimally important difference (MID) for the intercepts and slopes, and levels of changes were compared. Both Lokomat and tizanidine resulted in significant reduction in both intercept and slope of reflex and intrinsic stiffness. However, a higher proportion of subjects in Lok group achieved the MID for the reflex (>90%) and intrinsic (65-78%) parameters compared with Tiz group (up to 63% and 25% for reflex and intrinsic parameters, respectively). The levels of reduction were also higher in the Lok than the Tiz group. No one in the Cont group achieved the MID. Our findings demonstrate that LOKOMAT training can be more efficient in modifying neuromuscular abnormalities associated with spasticity than tizanidine.",2015,Both Lokomat and tizanidine resulted in significant reduction in both intercept and slope of reflex and intrinsic stiffness.,['persons with incomplete Spinal Cord Injury (SCI'],"['robotic-assisted locomotor (LOKOMAT) training or an anti-spastic medication (tizanidine', 'LOKOMAT training', 'robotic-assisted locomotor training', 'Tizanidine', 'tizanidine']","['MID', 'levels of reduction', 'reflex and intrinsic stiffness']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury (disorder)'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training (regime/therapy)'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0146011', 'cui_str': 'tizanidine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",,0.0129366,Both Lokomat and tizanidine resulted in significant reduction in both intercept and slope of reflex and intrinsic stiffness.,"[{'ForeName': 'Mehdi M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2015.7319437']
897,26736632,Effects of acute electromagnetic fields exposure on the interhemispheric homotopic functional connectivity during resting state.,"In this paper, we aimed to investigate the possible effects of acute radiofrequency electromagnetic fields (EMF) on the interhemispheric homotopic functional connectivity with resting state functional magnetic resonance imaging (fMRI) technique. We designed a controllable LTE-related EMF exposure environment at 2.573 GHz and performed the 30 min real/sham exposure experiments on human brain under the safety limits. The resting state fMRI signals were collected before and after EMF exposure. Then voxel-mirrored homotopic connectivity method was utilized to evaluate the acute effects of LTE EMF exposure on the homotopic functional connectivity between two human hemispheres. Based on our previous research, we further demonstrated that the 30 min short-term LTE EMF exposure would modulate the interhemispheric homotopic functional connectivity in resting state around the medial frontal gyrus and the paracentral lobule during the real exposure.",2015,Then voxel-mirrored homotopic connectivity method was utilized to evaluate the acute effects of LTE EMF exposure on the homotopic functional connectivity between two human hemispheres.,[],"['resting state functional magnetic resonance imaging (fMRI) technique', 'acute radiofrequency electromagnetic fields (EMF']","['resting state fMRI signals', 'interhemispheric homotopic functional connectivity']",[],"[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0275081,Then voxel-mirrored homotopic connectivity method was utilized to evaluate the acute effects of LTE EMF exposure on the homotopic functional connectivity between two human hemispheres.,"[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Shao', 'Affiliation': ''}, {'ForeName': 'Zhiye', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Tongning', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2015.7318732']
898,26736728,Brain network properties in depressed patients receiving seizure therapy: A graph theoretical analysis of peri-treatment resting EEG.,"Electroconvulsive therapy (ECT), the most efficacious antidepressant therapy for treatment-resistant depression, has been reported to alter functional brain network architecture by down-regulating connectivity in frontotemporal circuitry. Magnetic seizure therapy (MST), which induces therapeutic seizures with high dose repetitive transcranial magnetic stimulation, has been introduced to improve the seizure therapy risk/benefit ratio. Unfortunately, there is limited understanding of seizure therapy's underlying mechanisms of action. In this study, we apply graph theory-based connectivity analysis to peri-treatment, resting-state, topographical electroencephalography (EEG) in patients with depression receiving seizure therapy. Functional connectivity was assessed using the de-biased weighted phase lag index, a measure of EEG phase synchronization. Brain network structure was quantified using graph theory metrics, including betweenness centrality, clustering coefficient, network density, and characteristic path length. We found a significant reduction in the phase synchronization and aberration of the small-world architecture in the beta frequency band, which could be related to acute clinical and cognitive effects of seizure therapy.",2015,"We found a significant reduction in the phase synchronization and aberration of the small-world architecture in the beta frequency band, which could be related to acute clinical and cognitive effects of seizure therapy.","['depressed patients receiving seizure therapy', 'patients with depression receiving seizure therapy']","['graph theory-based connectivity analysis to peri-treatment, resting-state, topographical electroencephalography (EEG', 'Electroconvulsive therapy (ECT', 'Magnetic seizure therapy (MST']","['Functional connectivity', 'Brain network properties']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",,0.0223965,"We found a significant reduction in the phase synchronization and aberration of the small-world architecture in the beta frequency band, which could be related to acute clinical and cognitive effects of seizure therapy.","[{'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClinctock', 'Affiliation': ''}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2015.7318828']
899,26737823,The effect of lymph drainage on the myoelectric manifestation of vastus lateralis fatigue: Preliminary results.,"Variations in surface electromyograms (EMGs) collected from the vastus lateralis muscle during isometric fatiguing contractions were investigated pre-post lymphatic drainage (intervention group, N=3) and pre-post rest (control group, N=3). The slope of conduction velocity and of EMG amplitude and spectral descriptors was computed from the start to the failure time; the instant after which subjects could not endure contractions. When compared to subjects in the control group, those in the intervention group endured longer. Similarly, muscle fatigue affected to a lesser extent EMGs following lymphatic drainage than following rest. These preliminary results suggest the lymphatic drainage may potentially delay muscle fatigue.",2015,"When compared to subjects in the control group, those in the intervention group endured longer.",['vastus lateralis fatigue'],['lymph drainage'],['slope of conduction velocity and of EMG amplitude and spectral descriptors'],"[{'cui': 'C0015672', 'cui_str': 'Fatigue'}]","[{'cui': 'C0024202', 'cui_str': 'Lymph'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}]","[{'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber, function (observable entity)'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0282354', 'cui_str': 'Descriptors'}]",,0.0186367,"When compared to subjects in the control group, those in the intervention group endured longer.","[{'ForeName': 'Taian M', 'Initials': 'TM', 'LastName': 'Vieira', 'Affiliation': ''}, {'ForeName': 'Nathalli G', 'Initials': 'NG', 'LastName': 'Readi', 'Affiliation': ''}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Schwarcke', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Botter', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2015.7319923']
900,26738059,Pattern of active and inactive sequences of diabetes self-monitoring in mobile phone and paper diary users.,"In a pilot randomized controlled trial involving overweight or obese participants with type 2 diabetes, we find that smartphone users have sharply higher adherence to self-monitoring of diet, physical activity, blood glucose, and body weight, as compared to paper diary users. By characterizing the pattern of adherence with the probability of continuation of active and inactive sequences of self-monitoring, we find that smartphone users have longer active sequences of self-monitoring of all four behaviors that were being monitored. Smartphone users are also quicker to resume self-monitoring of diet and physical activity after a lapse in self-monitoring, whereas paper diary users have shorter inactive sequences for monitoring blood glucose and body weight. The findings are informative for data collection methodology in this burgeoning area of research.",2015,"Smartphone users are also quicker to resume self-monitoring of diet and physical activity after a lapse in self-monitoring, whereas paper diary users have shorter inactive sequences for monitoring blood glucose and body weight.","['overweight or obese participants with type 2 diabetes', 'mobile phone and paper diary users']",[],"['adherence to self-monitoring of diet, physical activity, blood glucose, and body weight']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",[],"[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",4.0,0.0248952,"Smartphone users are also quicker to resume self-monitoring of diet and physical activity after a lapse in self-monitoring, whereas paper diary users have shorter inactive sequences for monitoring blood glucose and body weight.","[{'ForeName': 'Nikhil S', 'Initials': 'NS', 'LastName': 'Padhye', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Jing Wang', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2015.7320159']
901,26524815,Comprehensive effect assessment of medical nutrition guidance during pregnancy towards the health of mothers and children.,"OBJECTIVE


This study evaluates the effects of medical nutrition guidance provided to pregnant women to reduce pregnancy complications and occurrence of low birth-weight children and macrosomia. This guideline aims to provide the basis for improving birth delivery outcomes.
MATERIALS AND METHODS


A randomized controlled method was used. A total of 261 parturient women who enrolled in regular pregnancy testing were sampled and selected. The subjects were randomly divided into experimental group (EG, n = 124) and control group (CG, n = 132). The differences in maternal health, pregnancy outcomes, and newborn health between the two groups were compared.
RESULTS


Hypertensive disorders in pregnancy and gestational diabetes risks in EG were significantly lower than those in CG (p < 0.05). The cesarean section rate decreased (EG 36.29%, CG 51.50%), and the vaginal delivery rate increased (EG 63.71%, CG 51.50%). The incidence of macrosomia in EG was significantly lower than that in CG (p < 0.05).
CONCLUSION


Medical nutrition guidance during pregnancy improves the perinatal outcomes of mothers and children.",2015,"The cesarean section rate decreased (EG 36.29%, CG 51.50%), and the vaginal delivery rate increased (EG 63.71%, CG 51.50%).","['pregnant women', '261 parturient women who enrolled in regular pregnancy testing were sampled and selected', 'mothers and children']","['Medical nutrition guidance', 'medical nutrition guidance']","['maternal health, pregnancy outcomes, and newborn health', 'vaginal delivery rate', 'incidence of macrosomia in EG', 'cesarean section rate', 'pregnancy complications and occurrence of low birth-weight children and macrosomia']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C4042838', 'cui_str': 'Health of Newborn Infants'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0158915', 'cui_str': 'Birth weight 4500 grams OR more'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0032962', 'cui_str': 'Pregnancy Complications'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",261.0,0.0170505,"The cesarean section rate decreased (EG 36.29%, CG 51.50%), and the vaginal delivery rate increased (EG 63.71%, CG 51.50%).","[{'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
902,30677538,A randomized controlled trial to reduce food allergy anxiety about casual exposure by holding the allergen: TOUCH study.,,2019,,[],[],[],[],[],[],,0.0922923,,"[{'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Weinberger', 'Affiliation': 'Department of Medicine and Allergy and Immunology, Hackensack University Medical Center, Hackensack, NJ.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Annunziato', 'Affiliation': 'Department of Psychology, Fordham University, New York, NY.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Riklin', 'Affiliation': 'Department of Psychology, Fordham University, New York, NY.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Shemesh', 'Affiliation': 'Department of Psychiatry and Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Sicherer', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: Scott.sicherer@mssm.edu.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.01.018']
903,31559948,Comparing alternating pressure mattresses and high-specification foam mattresses to prevent pressure ulcers in high-risk patients: the PRESSURE 2 RCT.,"BACKGROUND


Pressure ulcers (PUs) are a burden to patients, carers and health-care providers. Specialist mattresses minimise the intensity and duration of pressure on vulnerable skin sites in at-risk patients.
PRIMARY OBJECTIVE


Time to developing a new PU of category ≥ 2 in patients using an alternating pressure mattress (APM) compared with a high-specification foam mattress (HSFM).
DESIGN


A multicentre, Phase III, open, prospective, planned as an adaptive double-triangular group sequential, parallel-group, randomised controlled trial with an a priori sample size of 2954 participants. Randomisation used minimisation (incorporating a random element).
SETTING


The trial was set in 42 secondary and community inpatient facilities in the UK.
PARTICIPANTS


Adult inpatients with evidence of acute illness and at a high risk of PU development.
INTERVENTIONS AND FOLLOW-UP


APM or HSFM - the treatment phase lasted a maximum of 60 days; the final 30 days were post-treatment follow-up.
MAIN OUTCOME MEASURES


Time to event.
RESULTS


From August 2013 to November 2016, 2029 participants were randomised to receive either APM ( n  = 1016) or HSFM ( n  = 1013). Primary end point - 30-day final follow-up: of the 2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥ 2. There was insufficient evidence of a difference between groups for time to new PU of category ≥ 2 [Fine and Gray model HR 0.76, 95% confidence interval (CI) 0.56 to 1.04; exact  p -value of 0.0890 and 2% absolute difference]. Treatment phase sensitivity analysis: 132 (6.5%) participants developed a new PU of category ≥ 2 between randomisation and end of treatment phase. There was a statistically significant difference in the treatment phase time-to-event sensitivity analysis (Fine and Gray model HR 0.66, 95% CI 0.46 to 0.93;  p  = 0.0176 and 2.6% absolute difference). Secondary end points - 30-day final follow-up: new PUs of category ≥ 1 developed in 350 (17.2%) participants, with no evidence of a difference between mattress groups in time to PU development, (Fine and Gray model HR 0.83, 95% CI 0.67 to 1.02;  p -value = 0.0733 and absolute difference 3.1%). New PUs of category ≥ 3 developed in 32 (1.6%) participants with insufficient evidence of a difference between mattress groups in time to PU development (Fine and Gray model HR 0.81, 95% CI 0.40 to 1.62;  p  = 0.5530 and absolute difference 0.4%). Of the 145 pre-existing PUs of category 2, 89 (61.4%) healed - there was insufficient evidence of a difference in time to healing (Fine and Gray model HR 1.12, 95% CI 0.74 to 1.68;  p  = 0.6122 and absolute difference 2.9%). Health economics - the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small. There were no safety concerns. Blinded photography substudy - the reliability of central blinded review compared with clinical assessment for PUs of category ≥ 2 was 'very good' (kappa statistic 0.82, prevalence- and bias-adjusted kappa 0.82). Quality-of-life substudy - the Pressure Ulcer Quality of Life - Prevention (PU-QoL-P) instrument meets the established criteria for reliability, construct validity and responsiveness.
LIMITATIONS


A lower than anticipated event rate.
CONCLUSIONS


In acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain, APMs confer a small treatment phase benefit that is diminished over time. Overall, the APM patient compliance, very low PU incidence rate observed and small differences between mattresses indicate the need for improved indicators for targeting of APMs and individualised decision-making. Decisions should take into account skin status, patient preferences (movement ability and rehabilitation needs) and the presence of factors that may be potentially modifiable through APM allocation, including being completely immobile, having nutritional deficits, lacking capacity and/or having altered skin/category 1 PU.
FUTURE WORK


Explore the relationship between mental capacity, levels of independent movement, repositioning and PU development. Explore 'what works for whom and in what circumstances'.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN01151335.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 52. See the NIHR Journals Library website for further project information.",2019,"Health economics - the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small.","['2954 participants', 'at-risk patients', 'high-risk patients', '42 secondary and community inpatient facilities in the UK', 'acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain', 'Adult inpatients with evidence of acute illness and at a high risk of PU development', '2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥\u20092', 'From August 2013 to November 2016, 2029 participants']","['APM', 'HSFM', 'high-specification foam mattress (HSFM', 'alternating pressure mattress (APM']","['time to PU development', 'time to healing', ' 30-day final follow-up: new PUs of category ≥\u20091 developed', 'Time to event', 'treatment phase time-to-event sensitivity analysis', 'pressure ulcers', 'mental capacity, levels of independent movement, repositioning and PU development']","[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0024940', 'cui_str': 'Mattresses'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}]",2954.0,0.208005,"Health economics - the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Nixon', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Isabelle L', 'Initials': 'IL', 'LastName': 'Smith', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McGinnis', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Vargas-Palacios', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'E Andrea', 'Initials': 'EA', 'LastName': 'Nelson', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Coleman', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Collier', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fernandez', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gilberts', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Henderson', 'Affiliation': 'Independent Tissue Viability Consultant, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Institute of Health Economics, Edmonton, AB, Canada.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Muir', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rutherford', 'Affiliation': 'Quality of Life Office, Psycho-oncology Co-operative Research Group, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Stubbs', 'Affiliation': 'Neighbourhood Team North 1, Leeds Community Healthcare NHS Trust, Leeds, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Thorpe', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Wallner', 'Affiliation': 'Department of Emergency Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': 'Pressure Ulcer Research Service User Network, Leeds, UK.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Wilson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23520']
904,26411223,Ultrasonography versus laparoscopy in transcervical resection of septa: a randomized clinical trial.,"OBJECTIVE


To compare the effects of ultrasonography with laparoscopy on transcervical resection of septa (TCRS).
MATERIALS AND METHODS


The study included 126 patients with uterine septum at the present hospital between January 2010 and August 2012 that were randomly divided into two groups. Seventy patients had TCRS monitored by ultrasound (ultrasound group) while 56 patients were monitored by laparoscope (laparoscope group). Both groups were followed up for six to 24 months. The intraoperative status, short-term and long-term complications after operation, and pregnancy outcome of two groups were compared.
RESULTS


The operations of both groups were successfully completed. The operating time, the first time to get out of bed, postoperative 24hNRS (numeric rating scale) values, postoperative hospital stay, and the incidence of postoperative septum residue of ultrasound group were significantly less than laparoscope group (p < 0.05). No statistical differences were observed in intraoperative complications and pregnancy ratio between the two groups.
CONCLUSION


Both ultrasound and laparoscope monitored TCRS were safe and effective in the treatment of uterine septum. Ultrasound monitored TCRS was more simple, economical, accurate, and non-invasive. For patients without abnormal lesions in pelvic cavity, the present authors tend to choose the ultrasound monitored TCRS.",2015,"No statistical differences were observed in intraoperative complications and pregnancy ratio between the two groups.
","['126 patients with uterine septum at the present hospital between January 2010 and August 2012 that', 'Seventy patients had TCRS monitored by ultrasound (ultrasound group) while 56 patients were monitored by laparoscope (laparoscope group', 'transcervical resection of septa']","['Ultrasonography versus laparoscopy', 'Ultrasound monitored TCRS', 'ultrasound and laparoscope monitored TCRS', 'ultrasonography with laparoscopy']","['operating time, the first time to get out of bed, postoperative 24hNRS (numeric rating scale) values, postoperative hospital stay, and the incidence of postoperative septum residue', 'intraoperative complications and pregnancy ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023036', 'cui_str': 'Celioscopes'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0023036', 'cui_str': 'Celioscopes'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0222045'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",126.0,0.0212242,"No statistical differences were observed in intraoperative complications and pregnancy ratio between the two groups.
","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
905,26736984,Pharmacokinetic model for the inhibition of simvastatin metabolism by itraconazole.,"BACKGROUND


Concomitant use of simvastatin, a HMG-CoA reductase inhibitor, with a potent CYP3A4 inhibitor, itraconazole, can result in a serious drug-drug interaction induced severe adverse event, rhabdomyolysis. Even though pharmacokinetic data regarding such interaction are available, they cannot be used for quantitative prediction. For this reason, we aimed to develop a pharmacokinetic model for predicting the magnitude of inhibition of simvastatin metabolism by itraconazole.
METHODS


Published data involving pharmacokinetic of simvastatin, itraconazole, and pharmacokinetic interaction between simvastatin and itraconazole were selected from PubMed search. Serum simvastatin concentrations were subsequently extracted and used for model development. Advanced Continuous Simulating Language Extreme (ACSLX) was used for modeling.
RESULTS


The drug-drug interaction model between simvastatin and itraconazole was simultaneously modeled using a one compartment parent-metabolite model for simvastatin, and a two-compartment model for itraconazole.
CONCLUSION


The final drug-drug interaction model can adequately describe the actual simvastatin concentrations. Model application can be of advantage for dosing adjustment to avoid serious adverse effects resulted from concomitant use of both drugs.",2015,"The drug-drug interaction model between simvastatin and itraconazole was simultaneously modeled using a one compartment parent-metabolite model for simvastatin, and a two-compartment model for itraconazole.
",[],"['simvastatin, itraconazole', 'simvastatin and itraconazole', 'Advanced Continuous Simulating Language Extreme (ACSLX', 'itraconazole', 'simvastatin']",['Serum simvastatin concentrations'],[],"[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0140908,"The drug-drug interaction model between simvastatin and itraconazole was simultaneously modeled using a one compartment parent-metabolite model for simvastatin, and a two-compartment model for itraconazole.
","[{'ForeName': 'Manupat', 'Initials': 'M', 'LastName': 'Lohitnavy', 'Affiliation': ''}, {'ForeName': 'Janthima', 'Initials': 'J', 'LastName': 'Methaneethorn', 'Affiliation': ''}, {'ForeName': 'Rangsimaporn', 'Initials': 'R', 'LastName': 'Chiang-Ngernthanyakool', 'Affiliation': ''}, {'ForeName': 'Wasinee', 'Initials': 'W', 'LastName': 'Tongpeng', 'Affiliation': ''}, {'ForeName': 'Daranee', 'Initials': 'D', 'LastName': 'Chan-Im', 'Affiliation': ''}, {'ForeName': 'Suttipong', 'Initials': 'S', 'LastName': 'Phaohorm', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2015.7319084']
906,31540607,Effects of access barriers and medication acceptability on buprenorphine-naloxone treatment utilization over 2 years: Results from a multisite randomized trial of adults with opioid use disorder.,"BACKGROUND


Nationwide efforts seek to address the opioid epidemic by increasing access to medications for opioid use disorder (OUD), particularly with buprenorphine. A poorly understood challenge is that among individuals with OUD who do receive buprenorphine, many do not adhere to the pharmacotherapy long enough to achieve sustained benefits. We aimed to identify factors associated with buprenorphine treatment utilization over time.
METHODS


We used random-intercept modeling to identify factors associated with buprenorphine treatment utilization over 2 years after first follow-up by 789 individuals with OUD who had participated in a multi-site randomized clinical trial of buprenorphine compared to methadone. Key predictors were participants' reports of buprenorphine treatment accessibility and acceptability (assessed at first follow-up) and their interaction effects, controlling for baseline randomization status, sociodemographics, and other covariates.
RESULTS


Approximately 9.3-11.2% of participants utilized buprenorphine treatment over the 2 years of follow-up. Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors. In contrast, individuals who perceived buprenorphine to be unacceptable were least likely to use buprenorphine, regardless the level of perceived access to the medication. Buprenorphine treatment utilization was also negatively associated with Hispanic ethnicity, West coast context, and cumulative months receiving methadone treatment and incarceration during follow-up.
CONCLUSIONS


To engage more individuals with OUD in long-term treatment with buprenorphine, interventions should target buprenorphine treatment acceptability, in addition to increasing buprenorphine access, and tailor efforts to meet the needs of vulnerable populations.
TRIAL REGISTRATION


The START Follow-up Study on ClinicalTrials.gov (NCT01592461).",2019,"Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors.","['over 2\u202fyears after first follow-up by 789 individuals with OUD who had participated in a multi-site randomized clinical trial of', 'individuals with OUD', 'adults with opioid use disorder', '2\u202fyears']","['methadone', 'buprenorphine-naloxone', 'buprenorphine', 'Buprenorphine', 'buprenorphine treatment utilization']",['Interaction effects'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042153', 'cui_str': 'use'}]","[{'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",789.0,0.0456768,"Interaction effects indicated that individuals who perceived buprenorphine to be both accessible and acceptable were most likely to use buprenorphine during follow-up, controlling for other factors.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Evans', 'Affiliation': 'Department of Health Promotion and Policy, School of Public Health and Health Sciences, University of Massachusetts Amherst, 312 Arnold House, 715 North Pleasant St. Amherst, MA 01003, USA. Electronic address: eaevans@umass.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Yoo', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: cyoo5@ucla.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: yhuang@ucla.edu.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Saxon', 'Affiliation': 'Veterans Affairs Puget Sound Health Care System, 1660 S Columbian Way, Seattle, WA 98108, USA. Electronic address: Andrew.Saxon@va.gov.'}, {'ForeName': 'Yih-Ing', 'Initials': 'YI', 'LastName': 'Hser', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior, 11075 Santa Monica Blvd. Ste 200, Los Angeles, CA 90024. USA. Electronic address: yhser@ucla.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.002']
907,32418659,Extracorporeal Shockwave Therapy and Knee Osteoarthritis: Defining a Placebo Group.,,2020,,['and Knee Osteoarthritis'],"['Extracorporeal Shockwave Therapy', 'Placebo']",[],"[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.018528,,"[{'ForeName': 'Goksel', 'Initials': 'G', 'LastName': 'Tanigor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, İzmir, Turkey.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Hepguler', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Ege University Faculty of Medicine, Bornova, İzmir, Turkey.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.02.018']
908,31549793,Baseline Objective Inflammation by Magnetic Resonance Imaging as a Predictor of Therapeutic Benefit in Early Rheumatoid Arthritis With Poor Prognosis.,"OBJECTIVE


High magnetic resonance imaging (MRI)-detected inflammation is associated with greater progression and poorer outcomes in rheumatoid arthritis (RA). This analysis aimed to determine if baseline MRI inflammation was related to clinical response and remission in the Assessing Very Early Rheumatoid arthritis Treatment (AVERT) study.
METHODS


AVERT was a phase IIIb, randomized, controlled trial with a 12-month, double-blind treatment period enrolling patients with early (≤2 years' duration), anti-citrullinated peptide-positive methotrexate (MTX)-naive RA. In this post hoc analysis, patients in the abatacept plus MTX (n = 114) and MTX (n = 111) arms with available MRI results were stratified into low and high baseline MRI inflammation groups based on previously developed cutoffs of synovitis and osteitis on unilateral hand-wrist contrast-enhanced MRI. Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score in 28 joints using the C-reactive protein level (<2.6) were assessed.
RESULTS


Overall, 100 of 225 patients (44.4%) had high baseline MRI inflammation. In patients with high baseline MRI inflammation, a significantly greater proportion achieved remission at 12 months with abatacept plus MTX versus MTX across SDAI (45.1% versus 16.3%; P = 0.0022), CDAI (47.1% versus 20.4%; P = 0.0065), and Boolean indices (39.2% versus 16.3%; P = 0.0156). In patients with low baseline MRI inflammation, remission rates were not significantly different with abatacept plus MTX versus MTX (SDAI: 39.7% versus 32.3%; P = 0.4961).
CONCLUSION


In seropositive, MTX-naive patients with early RA and presence of objectively measured high inflammation by MRI, indicating poor prognosis, remission rates were higher with abatacept plus MTX treatment versus MTX.",2020,"Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score in 28 joints (C-reactive protein)","[""enrolling patients with early (≤2 years' duration), anti-citrullinated peptide-positive methotrexate (MTX)-naïve RA""]","['MTX', 'abatacept+MTX treatment versus MTX', 'Magnetic Resonance Imaging', 'magnetic resonance imaging', 'abatacept+MTX versus MTX', 'abatacept+MTX']","['Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score', 'remission rates', 'Boolean indices', 'CDAI', 'remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}]",,0.295007,"Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score in 28 joints (C-reactive protein)","[{'ForeName': 'Harris A', 'Initials': 'HA', 'LastName': 'Ahmad', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Joshua F', 'Initials': 'JF', 'LastName': 'Baker', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Rigshospitalet, Glostrup, Denmark, and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Durez', 'Affiliation': 'Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Subhashis', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.'}]",Arthritis care & research,['10.1002/acr.24072']
909,26184520,"Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial.","BACKGROUND


Tumour mutational status is an important determinant of the response of metastatic colorectal cancer to targeted treatments. However, the genotype of the tissue obtained at the time of diagnosis might not accurately represent tumour genotype after multiple lines of treatment. This retrospective exploratory analysis investigated the clinical activity of regorafenib in biomarker subgroups of the CORRECT study population defined by tumour mutational status or plasma protein levels.
METHODS


We used BEAMing technology to identify KRAS, PIK3CA, and BRAF mutations in DNA obtained from the plasma of 503 patients with metastatic colorectal cancer who enrolled in the CORRECT trial. We quantified total human genomic DNA isolated from plasma samples for 503 patients using a modified version of human long interspersed nuclear element-1 (LINE-1) quantitive real-time PCR. We also measured the concentration of 15 proteins of interest-angiopoietin 2, interleukin 6, interleukin 8, placental growth factor, soluble TIE-1, soluble VEGFR1, VEGF-A, VEGF-C, VEGF-D, VEGF-A isoform 121, bone morphogenetic protein 7, macrophage colony-stimulating factor, stromal cell-derived factor-1, tissue inhibitor of metalloproteinase 2, and von Willebrand factor-in plasma samples from 611 patients. We did correlative analyses of overall survival and progression-free survival in patient subgroups based on mutational status, circulating DNA concentration, and protein concentrations. The CORRECT trial was registered with ClinicalTrials.gov, number NCT01103323.
FINDINGS


Tumour-associated mutations were readily detected with BEAMing of plasma DNA, with KRAS mutations identified in 349 (69%) of 503 patients, PIK3CA mutations in 84 (17%) of 503 patients, and BRAF mutations in 17 (3%) of 502 patients. We did not do correlative analysis based on BRAF genotype because of the low mutational frequency detected for this gene. Some of the most prevalent individual hot-spot mutations we identified included: KRAS (KRAS G12D, 116 [28%] of 413 mutations; G12V, 72 [17%]; and G13D, 67 [16%]) and PIK3CA (PIK3CA E542K, 27 [30%] of 89 mutations; E545K, 37 [42%]; and H1047R, 12 [14%]). 41 (48%) of 86 patients who had received anti-EGFR therapy and whose archival tumour tissue DNA was KRAS wild-type in BEAMing analysis were identified as having KRAS mutations in BEAMing analysis of fresh plasma DNA. Correlative analyses suggest a clinical benefit favouring regorafenib across patient subgroups defined by KRAS and PIK3CA mutational status (progression-free survival with regorafenib vs placebo: hazard ratio [HR] 0·52, 95% CI 0·35-0·76 for KRAS wild-type; HR 0·51, 95% CI 0·40-0·65 for KRAS mutant [KRAS wild type vs mutant, pinteraction=0·74]; HR 0·50, 95% CI 0·40-0·63 for PIK3CA wild-type; HR 0·54, 95% CI 0·32-0·89 for PIK3CA mutant [PIK3CA wild-type vs mutant, pinteraction=0·85]) or circulating DNA concentration (progression-free survival with regorafenib vs placebo: HR 0·53, 95% CI 0·40-0·71, for low circulating DNA concentrations; HR 0·52, 95% CI 0·40-0·70, for high circulating DNA concentrations; low vs high circulating DNA, pinteraction=0·601). With the exception of von Willebrand factor, assessed with the median cutoff method, plasma protein concentrations were also not associated with regorafenib activity in terms of progression-free survival. In univariable analyses, the only plasma protein that was associated with overall survival was TIE-1, high concentrations of which were associated with longer overall survival compared with low TIE-1 concentrations. This association was not significant in multivariable analyses.
INTERPRETATION


BEAMing of circulating DNA could be a viable approach for non-invasive analysis of tumour genotype in real time and for the identification of potentially clinically relevant mutations that are not detected in archival tissue. Additionally, the results show that regorafenib seems to be consistently associated with a clinical benefit in a range of patient subgroups based on mutational status and protein biomarker concentrations.
FUNDING


Bayer HealthCare Pharmaceuticals.",2015,"Correlative analyses suggest a clinical benefit favouring regorafenib across patient subgroups defined by KRAS and PIK3CA mutational status (progression-free survival with regorafenib vs placebo: hazard ratio [HR] 0·52, 95% CI 0·35-0·76 for KRAS wild-type; HR 0·51, 95% CI 0·40-0·65 for KRAS mutant [KRAS wild type vs mutant, pinteraction=0·74];","['503 patients using a modified version of human long interspersed nuclear element-1 (LINE-1) quantitive real-time PCR', 'patients with metastatic colorectal cancer', '503 patients with metastatic colorectal cancer who enrolled in the CORRECT trial', '611 patients']","['regorafenib vs placebo', 'anti-EGFR therapy']","['concentration of 15 proteins of interest-angiopoietin 2, interleukin 6, interleukin 8, placental growth factor, soluble TIE-1, soluble VEGFR1, VEGF-A, VEGF-C, VEGF-D, VEGF-A isoform 121, bone morphogenetic protein 7, macrophage colony-stimulating factor, stromal cell-derived factor-1, tissue inhibitor of metalloproteinase 2, and von Willebrand factor-in plasma samples', 'overall survival', 'low circulating DNA concentrations', 'median cutoff method, plasma protein concentrations', 'circulating DNA concentration (progression-free survival', 'overall survival and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0540511', 'cui_str': 'Angiopoietin-2'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0388911', 'cui_str': 'Vascular Endothelial Growth Factor C'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor D'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0083867', 'cui_str': 'BMP-7'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0218504', 'cui_str': 'Chemokine (C-X-C Motif) Ligand 12'}, {'cui': 'C0145946', 'cui_str': 'Tissue Inhibitor of Metalloproteinase-2'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4289789', 'cui_str': 'Cell-Free Deoxyribonucleic Acid'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0032120', 'cui_str': 'Plasma Proteins'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",503.0,0.144941,"Correlative analyses suggest a clinical benefit favouring regorafenib across patient subgroups defined by KRAS and PIK3CA mutational status (progression-free survival with regorafenib vs placebo: hazard ratio [HR] 0·52, 95% CI 0·35-0·76 for KRAS wild-type; HR 0·51, 95% CI 0·40-0·65 for KRAS mutant [KRAS wild type vs mutant, pinteraction=0·74];","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain. Electronic address: jtabernero@vhio.net.""}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'University of Southern California/Norris Comprehensive Cancer Center, Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Siena', 'Affiliation': ""Niguarda Cancer Center, Ospedale Niguarda Ca' Granda, Milan, Italy; Università di Milano, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'IRCCS San Martino IST, Genoa, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'University Hospital, Pisa, Italy.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ychou', 'Affiliation': ""ICM-Val d'Aurelle, Montpellier, France.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Humblet', 'Affiliation': 'St-Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouché', 'Affiliation': 'Centre Hospitalier Universitaire Reims, Robert Debré Hospital, Reims, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Gastrointestinal and Liver Oncology Unit, Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Barone', 'Affiliation': 'Catholic University of Sacred Heart, Rome, Italy.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Adenis', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'Ohio State University School of Medicine, James Cancer Hospital and Solove Research Institute, Columbus, OH, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Sargent', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wagner', 'Affiliation': 'Bayer Pharma AG, Berlin, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Laurent', 'Affiliation': 'Bayer Pharma AG, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Teufel', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jeffers', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Grothey', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospital Gasthuisberg/Leuven and KU Leuven, Leuven, Belgium.'}]",The Lancet. Oncology,['10.1016/S1470-2045(15)00138-2']
910,32063041,SUPPORT-AF II: Supporting Use of Anticoagulants Through Provider Profiling of Oral Anticoagulant Therapy for Atrial Fibrillation: A Cluster-Randomized Study of Electronic Profiling and Messaging Combined With Academic Detailing for Providers Making Decisions About Anticoagulation in Patients With Atrial Fibrillation.,"BACKGROUND


Previous provider-directed electronic messaging interventions have not by themselves improved anticoagulation use in patients with atrial fibrillation. Direct engagement with providers using academic detailing coupled with electronic messaging may overcome the limitations of the prior interventions.
METHODS AND RESULTS


We randomized outpatient providers affiliated with our health system in a 2.5:1 ratio to our electronic profiling/messaging combined with academic detailing intervention. In the intervention, we emailed providers monthly reports of their anticoagulation percentage relative to peers for atrial fibrillation patients with elevated stroke risk (CHA 2 DS 2 -VASc ≥2). We also sent electronic medical record-based messages shortly before an appointment with an anticoagulation-eligible but untreated atrial fibrillation patient. Providers had the option to send responses with explanations for prescribing decisions. We also offered to meet with intervention providers using an academic detailing approach developed based on knowledge gaps discussed in provider focus groups. To assess feasibility, we tracked provider review of our messages. To assess effectiveness, we measured the change in anticoagulation for patients of intervention providers relative to controls. We identified 85 intervention and 34 control providers taking care of 3591 and 1908 patients, respectively; 33 intervention providers participated in academic detailing. More than 80% of intervention providers read our emails, and 98% of the time a provider reviewed our in-basket messages. Replies to messages identified patient refusal as the most common reason for patients not being on anticoagulation (11.2%). For the group of patients not on anticoagulation at baseline assigned to an intervention versus control provider, the adjusted percent increase in the use of anticoagulation over 6 months was 5.2% versus 7.4%, respectively ( P =0.21).
CONCLUSIONS


Our electronic messaging and academic detailing intervention was feasible but did not increase anticoagulation use. Patient-directed interventions or provider interventions targeting patients declining anticoagulation may be necessary to raise the rate of anticoagulation. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03583008.",2020,"We identified 85 intervention and 34 control providers taking care of 3591 and 1908 patients, respectively; 33 intervention providers participated in academic detailing.","['atrial fibrillation patients with elevated stroke risk (CHA 2 DS 2 -VASc ≥2', 'We randomized outpatient providers affiliated with our health system in a 2.5:1 ratio to our electronic profiling/messaging combined with academic detailing intervention', '34 control providers taking care of 3591 and 1908 patients, respectively; 33 intervention providers participated in academic detailing', 'Patients With Atrial Fibrillation', 'patients with atrial fibrillation', 'Atrial Fibrillation', 'patients of intervention providers relative to controls']","['SUPPORT-AF II', 'Electronic Profiling and Messaging Combined With Academic Detailing for Providers Making Decisions']",[],"[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",[],,0.098147,"We identified 85 intervention and 34 control providers taking care of 3591 and 1908 patients, respectively; 33 intervention providers participated in academic detailing.","[{'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester (A.K., A.A, E.A., R.E., D.D.M.).'}, {'ForeName': 'Azraa', 'Initials': 'A', 'LastName': 'Amroze', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester (A.K., A.A, E.A., R.E., D.D.M.).'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Vakil', 'Affiliation': ""Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH (F.V.).""}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Crawford', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Der', 'Affiliation': 'Northeastern University, Boston, MA (J.D., J.S.S.).'}, {'ForeName': 'Jomol', 'Initials': 'J', 'LastName': 'Mathew', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Alper', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester (A.K., A.A, E.A., R.E., D.D.M.).'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Yogaratnam', 'Affiliation': 'Mass College of Pharmacy and Health Sciences, Worcester, MA (D.Y., D.B.).'}, {'ForeName': 'Saud', 'Initials': 'S', 'LastName': 'Javed', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Elhag', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester (A.K., A.A, E.A., R.E., D.D.M.).'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Narayanan', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': 'Mass College of Pharmacy and Health Sciences, Worcester, MA (D.Y., D.B.).'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Nagy', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Bevin Kathleen', 'Initials': 'BK', 'LastName': 'Shagoury', 'Affiliation': ""The National Resource Center for Academic Detailing, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA (B.K.S., M.A.F.).""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Fischer', 'Affiliation': ""The National Resource Center for Academic Detailing, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA (B.K.S., M.A.F.).""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Saczynski', 'Affiliation': 'University of Massachusetts Medical School, Worcester (A.K., S.C., J.M., E.A., S.J., R.E., A.L., S.N., A.N., K.M.M., J.S.S., D.D.M.).'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston (J.M.A.).'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (R.L.).'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'McManus', 'Affiliation': 'University of Massachusetts Memorial Health Care, Worcester (A.K., A.A, E.A., R.E., D.D.M.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.005871']
911,25937522,FOLFOX4 plus cetuximab treatment and RAS mutations in colorectal cancer.,"BACKGROUND


The OPUS study demonstrated that addition of cetuximab to 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX4) significantly improved objective response and progression-free survival (PFS) in the first-line treatment of patients with KRAS exon 2 wild-type metastatic colorectal cancer (mCRC). In patients with KRAS exon 2 mutations, a detrimental effect was seen upon addition of cetuximab to FOLFOX4. The current study reports outcomes in subgroups defined by extended RAS testing.
PATIENTS AND METHODS


Samples from OPUS study KRAS exon 2 wild-type tumours were reanalysed for other RAS mutations in four additional KRAS codons (exons 3-4) and six NRAS codons (exons 2-4) using BEAMing. A cutoff of ⩾5% mutant/wild-type sequences was selected to define RAS status; we also report an analysis using a cutoff based on the technical lower limit for mutation identification (0.1%).
RESULTS


Other RAS mutations were detected in 31/118 (26%) evaluable patients. In the extended analysis of RAS wild-type tumours (n=87), objective response was significantly improved by addition of cetuximab to FOLFOX4 (58% versus 29%; odds ratio 3.33 [95% confidence interval 1.36-8.17]; P=0.0084); although limited by population size, there also appeared to be trends favouring the cetuximab arm in terms of PFS and overall survival in the RAS wild-type group compared with the RAS evaluable group. There was no evidence that patients with other RAS mutations benefited from cetuximab, but small numbers precluded precise estimations of treatment effects. In the combined population of patients with any RAS mutation (KRAS exon 2 or other RAS), a clear detrimental effect was associated with addition of cetuximab to FOLFOX4.
CONCLUSION


Patients with RAS-mutant mCRC, as defined by mutations in KRAS and NRAS exons 2-4, derive no benefit and may be harmed by the addition of cetuximab to FOLFOX4. Restricting cetuximab administration to patients with RAS wild-type tumours will further tailor therapy to maximise benefit.",2015,"In the extended analysis of RAS wild-type tumours (n=87), objective response was significantly improved by addition of cetuximab to FOLFOX4 (58% versus 29%; odds ratio 3.33 [95% confidence interval 1.36-8.17]; P=0.0084); although limited by population size, there also appeared to be trends favouring the cetuximab arm in terms of PFS and overall survival in the RAS wild-type group compared with the RAS evaluable group.","['patients with any RAS mutation (KRAS exon 2 or other RAS', 'patients with KRAS exon 2 wild-type metastatic colorectal cancer (mCRC', 'colorectal cancer', 'patients with RAS wild-type tumours', 'Samples from OPUS study KRAS exon 2 wild-type tumours were reanalysed for other RAS mutations in four additional KRAS codons (exons 3-4) and six NRAS codons (exons 2-4) using BEAMing']","['FOLFOX4 plus cetuximab', 'cetuximab to 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX4']","['objective response', 'objective response and progression-free survival (PFS', 'PFS and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009221', 'cui_str': 'Codon'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.145778,"In the extended analysis of RAS wild-type tumours (n=87), objective response was significantly improved by addition of cetuximab to FOLFOX4 (58% versus 29%; odds ratio 3.33 [95% confidence interval 1.36-8.17]; P=0.0084); although limited by population size, there also appeared to be trends favouring the cetuximab arm in terms of PFS and overall survival in the RAS wild-type group compared with the RAS evaluable group.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Oncology, Haematology and Bone Marrow Transplantation with Section Pneumology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Köhne', 'Affiliation': 'Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ciardiello', 'Affiliation': 'Division of Medical Oncology, Department of Experimental and Clinical Medicine and Surgery ""F. Magrassi and A. Lanzara"", Second University of Naples, Naples, Italy.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Center, University Hospital Grosshadern, Munich, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Klinkhardt', 'Affiliation': 'Global Clinical Development Unit Oncology, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Beier', 'Affiliation': 'Global Biostatistics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Duecker', 'Affiliation': 'Biomarker Technologies & Operations, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'van Krieken', 'Affiliation': 'Department of Pathology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tejpar', 'Affiliation': 'Molecular Digestive Oncology, University Hospitals Leuven and KU Leuven, Leuven, Belgium. Electronic address: sabine.tejpar@uzleuven.be.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2015.04.007']
912,26116695,Exenatide Regulates Cerebral Glucose Metabolism in Brain Areas Associated With Glucose Homeostasis and Reward System.,"Glucagon-like peptide 1 receptors (GLP-1Rs) have been found in the brain, but whether GLP-1R agonists (GLP-1RAs) influence brain glucose metabolism is currently unknown. The study aim was to evaluate the effects of a single injection of the GLP-1RA exenatide on cerebral and peripheral glucose metabolism in response to a glucose load. In 15 male subjects with HbA1c of 5.7 ± 0.1%, fasting glucose of 114 ± 3 mg/dL, and 2-h glucose of 177 ± 11 mg/dL, exenatide (5 μg) or placebo was injected in double-blind, randomized fashion subcutaneously 30 min before an oral glucose tolerance test (OGTT). The cerebral glucose metabolic rate (CMRglu) was measured by positron emission tomography after an injection of [(18)F]2-fluoro-2-deoxy-d-glucose before the OGTT, and the rate of glucose absorption (RaO) and disposal was assessed using stable isotope tracers. Exenatide reduced RaO0-60 min (4.6 ± 1.4 vs. 13.1 ± 1.7 μmol/min ⋅ kg) and decreased the rise in mean glucose0-60 min (107 ± 6 vs. 138 ± 8 mg/dL) and insulin0-60 min (17.3 ± 3.1 vs. 24.7 ± 3.8 mU/L). Exenatide increased CMRglu in areas of the brain related to glucose homeostasis, appetite, and food reward, despite lower plasma insulin concentrations, but reduced glucose uptake in the hypothalamus. Decreased RaO0-60 min after exenatide was inversely correlated to CMRglu. In conclusion, these results demonstrate, for the first time in man, a major effect of a GLP-1RA on regulation of brain glucose metabolism in the absorptive state.",2015,"Exenatide increased CMRglu in areas of the brain related to glucose homeostasis, appetite, and food reward, despite lower plasma insulin concentrations, but reduced glucose uptake in the hypothalamus.","['15 male subjects with HbA1c of 5.7 ± 0.1%, fasting glucose of 114 ± 3 mg/dL, and 2-h glucose of 177 ± 11 mg/dL, exenatide (5 μg) or', 'Brain Areas']","['GLP-1RA exenatide', 'placebo', 'Exenatide', 'Glucagon-like peptide 1 receptors (GLP-1Rs', 'GLP-1RA']","['rate of glucose absorption (RaO) and disposal', 'cerebral glucose metabolic rate (CMRglu', 'brain glucose metabolism']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",15.0,0.059067,"Exenatide increased CMRglu in areas of the brain related to glucose homeostasis, appetite, and food reward, despite lower plasma insulin concentrations, but reduced glucose uptake in the hypothalamus.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Daniele', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Iozzo', 'Affiliation': 'Institute of Clinical Physiology, Pisa, Italy.'}, {'ForeName': 'Marjorie', 'Initials': 'M', 'LastName': 'Molina-Carrion', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Lancaster', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX.'}, {'ForeName': 'Demetrio', 'Initials': 'D', 'LastName': 'Ciociaro', 'Affiliation': 'Institute of Clinical Physiology, Pisa, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX.'}, {'ForeName': 'Devjit', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fox', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Musi', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX Institute of Clinical Physiology, Pisa, Italy amalia@ifc.cnr.it.'}]",Diabetes,['10.2337/db14-1718']
913,31412278,Eat to avoid negative self-awareness: Locus of control and core self-evaluation as serial mediators in the effect of stress on food intake.,"The primary hypothesis of escape theory lies in that those who are under stress eat to escape from negative self-awareness. Although escape theory has been well cited in the eating literature, relatively few studies have directly tested its applicability to stress-induced eating. The aim of the present study is to provide causal evidence on using escape theory to explain the effect of stress on food intake. Specifically, we examined whether locus of control (LOC) and core self-evaluation (CSE) are serial mediators in the effect of stress on food intake. By a longitudinal experimental design, participants were randomly assigned to a stress group or a control group, and data on LOC, CSE, and food intake were collected at 3 waves. The results indicated that LOC and CSE are serial mediators in the effect of stress on food intake, though the direct effect of stress conditions remained significant. Our findings support the applicability of escape theory to interpret why stress increases food intake, and exclusion of LOC as an indicator of CSE. Thus, the present study provides causal evidence on escape theory by shedding light on the sequential mediating effect of LOC and CSE. Future research need to pay more attention to the evaluative process in stress-induced eating.",2019,"Our findings support the applicability of escape theory to interpret why stress increases food intake, and exclusion of LOC as an indicator of CSE.",[],['control (LOC) and core self-evaluation (CSE'],[],[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C2936633', 'cui_str': 'Self-Evaluation'}]",[],,0.0158539,"Our findings support the applicability of escape theory to interpret why stress increases food intake, and exclusion of LOC as an indicator of CSE.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qi', 'Affiliation': 'Institute of Brain and Education Innovation, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Institute of Brain and Education Innovation, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China. Electronic address: ljcui@psy.ecnu.edu.cn.'}]",Appetite,['10.1016/j.appet.2019.104401']
914,26054119,Efficacy of chlortetracycline treatment on vulvar non-neoplastic epithelial disorders.,"OBJECTIVE


To observe the effectiveness of chlortetracycline (aureomycin) treatment on vulval white lesions and to explore its possible pathogenesis.
MATERIALS AND METHODS


From January 2001 to April 2011, 194 patients with vulvar non-neoplastic epithelial disorders were divided into three groups according to therapy regimens received, ie, chlortetracycline treatment group (72 cases), chlortetracycline + beclomethasone treatment group (66 cases), and beclomethasone treatment group (56 cases); their local changes of vulvar lesions were observed and efficacy of these treatment profiles was evaluated after one year.
RESULTS


Effective rates of chlortetracycline group, chlortetracycline + clobetasol group and clobetasol groups were 86.1% (62/72), 87.9% (58/66), and 62.5% (35/56), respectively. There was a significant difference among these three groups (Hc = 10.7766,p = 0.0046), the curative rate of clobetasol group was markedly lower than that of the former two groups (p = 0.0072 and p = 0.0019), but was not statistical significant (p = 0.6077) when compared between the former groups.
CONCLUSION


The occurrence of vulvar non-neoplastic epithelial disorders may be associated with chlamydia and mycoplasma infection, the chlortetracycline is an effective drug for this illness, the mechanism of which might be related to killing pathogens directly and inhibiting inflammatory mediators.",2015,"There was a significant difference among these three groups (Hc = 10.7766,p = 0.0046), the curative rate of clobetasol group was markedly lower than that of the former two groups (p = 0.0072 and p = 0.0019), but was not statistical significant (p = 0.6077) when compared between the former groups.
","['vulvar non-neoplastic epithelial disorders', 'From January 2001 to April 2011, 194 patients with vulvar non-neoplastic epithelial disorders']","['chlortetracycline + beclomethasone', 'beclomethasone', 'chlortetracycline treatment', 'chlortetracycline (aureomycin']","['local changes of vulvar lesions', 'curative rate']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0008293', 'cui_str': 'Chlortetracycline'}, {'cui': 'C0004905', 'cui_str': 'Beclomethasone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0728748', 'cui_str': 'Aureomycin'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}]",194.0,0.013785,"There was a significant difference among these three groups (Hc = 10.7766,p = 0.0046), the curative rate of clobetasol group was markedly lower than that of the former two groups (p = 0.0072 and p = 0.0019), but was not statistical significant (p = 0.6077) when compared between the former groups.
","[{'ForeName': 'G T', 'Initials': 'GT', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'S Z', 'Initials': 'SZ', 'LastName': 'Guo', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
915,25864252,A randomized-clinical trial examining a neoprene abdominal binder in gynecologic surgery patients.,"PURPOSE OF INVESTIGATION


Pain control and early ambulation are two important postoperative goals. Strategies that decrease morphine use while increasing ambulation have the potential to decrease postoperative complications. In this study the authors sought to determine the effect of an abdominopelvic binder on postoperative morphine use, pain, and ambulation in the first day after surgery.
MATERIALS AND METHODS


The authors randomly assigned 75 patients undergoing abdominal gynecologic surgery to either binder or not after surgery. Demographic data and surgical characteristics were collected. Outcome variables included morphine use, pain score, time to ambulation, and number of ambulations.
RESULTS


A group at high risk for decreased mobility was identified and the binder increased the number of ambulatory events by 300%, 260%, and 240% in patients with vertical incisions, age over 50 years, and complex surgeries, respectively. Morphine use and pain scores were not significantly different.
CONCLUSION


The binder increased ambulations in the subset of patients at the highest risk for postoperative complications: elderly, cancer patients, and vertical incisions. Routine use of the binder may benefit particularly high-risk gynecologic surgical patients.",2014,"Morphine use and pain scores were not significantly different.
","['75 patients undergoing', 'gynecologic surgery patients', 'high-risk gynecologic surgical patients']","['morphine', 'neoprene abdominal binder', 'Morphine', 'abdominal gynecologic surgery to either binder or not after surgery', 'abdominopelvic binder']","['morphine use, pain score, time to ambulation, and number of ambulations', 'postoperative complications', 'pain scores', 'postoperative morphine use, pain, and ambulation', 'number of ambulatory events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0027673', 'cui_str': 'Chloroprene Polymer'}, {'cui': 'C0179303', 'cui_str': 'Abdominal binder, device (physical object)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",75.0,0.0853548,"Morphine use and pain scores were not significantly different.
","[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Szender', 'Affiliation': ''}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Kost', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
916,25864279,"Effect of hypertonic sodium chloride hydroxyethyl starch 40 on ET, TXB2, 6-keto-PGF1α, and ANP of preeclampsia in caesarean section.","OBJECTIVE


Preeclampsia is a unique disease of pregnancy. Delivery via caesarean section is the most important way of terminating the pregnancy and treating preeclampsia. Perioperative fluid therapy is performed to maintain the circulatory volume and reduce tissue edema. This study evaluated the effects of hypertonic sodium chloride hydroxyethyl starch 40 (HSH40) as perioperative fluid therapy for preeclampsia patients.
MATERIALS AND METHODS


Forty preeclamptic women were randomly divided into two groups: the Ringer's solution group and the HSH40 group. Their ECG, HR, MAP, and SPO2 were monitored. Their MVP and HR were recorded at five, eight, and ten minutes after anesthesia induction and at the end of the caesarean section. The corresponding volume of infusion, blood loss, and urine output during the operation were also recorded. Venous samples were collected before HSH40 infusion and 30 min after infusion to measure the plasma concentrations of ET, TXB2, 6-keto-PGF1α, and ANP via a radioimmunoassay.
RESULTS


HSH40 infusion significantly decreased the plasma ET levels (p < 0.01), significantly changed the plasma ANP and TXB2 levels (p < 0.05), and significantly increased the plasma 6-keto-PGF1α levels (p < 0.01) in the experimental group compared with those before infusion. The plasma levels of ET, ANP, TXB2, and 6-keto-PGF1α did not significantly change in the control group. Compared with T1, MAP decreased significantly at T2, T3, T4, and T5 within groups (p < 0.05) and between the two groups. MAP significantly changed at T2, T3, T4, and T5 (p < 0.05). HR did not significant change at T1, T2, T3, T4, and T5 within or between groups. Volume of infusion and urine volume significantly differed between groups (p < 0.05).
CONCLUSION


Low-dose HSH40 lowers the plasma levels of vasoconstrictor substances (ET and TXB2) and increases the levels of vasodilator substances (6-keto-PGF1α and ANP) during preeclampsia. It effectively maintains and stabilizes the circulating blood volume, increasing renal blood flow, which improves renal function and increases urine output.",2015,"MAP significantly changed at T2, T3, T4, and T5 (p < 0.05).","['Forty preeclamptic women', 'preeclampsia patients']","['hypertonic sodium chloride hydroxyethyl starch', 'hypertonic sodium chloride hydroxyethyl starch 40 (HSH40', ""Ringer's solution group and the HSH40 group""]","['renal blood flow', 'plasma concentrations of ET, TXB2, 6-keto-PGF1α, and ANP via a radioimmunoassay', 'renal function and increases urine output', 'plasma ET levels', 'corresponding volume of infusion, blood loss, and urine output', 'plasma 6-keto-PGF1α levels', 'plasma levels of ET, ANP, TXB2, and 6-keto-PGF1α', 'Volume of infusion and urine volume', 'plasma levels of vasoconstrictor substances (ET and TXB2', 'plasma ANP and TXB2 levels', 'ECG, HR, MAP, and SPO2', 'ET, TXB2, 6-keto-PGF1α, and ANP of preeclampsia in caesarean section', 'levels of vasodilator substances (6-keto-PGF1α and ANP']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0073386', 'cui_str': ""Ringer's Solution""}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1527409', 'cui_str': 'Renal blood flow, function (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040059', 'cui_str': 'Thromboxa-5,13-dien-1-oic acid, 9,11,15-trihydroxy-, (5Z,9alpha,13E,15S)-'}, {'cui': 'C0027481', 'cui_str': 'Atriopeptins'}, {'cui': 'C0034580', 'cui_str': 'Radioimmunoassay'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0032617', 'cui_str': 'Polyuria'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1287298', 'cui_str': 'UO - Urine output'}, {'cui': 'C0042397', 'cui_str': 'Vasoactive Agonists'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator Drugs'}]",40.0,0.0238936,"MAP significantly changed at T2, T3, T4, and T5 (p < 0.05).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'l H', 'Initials': 'lH', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Wei', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
917,32418164,"Personalized Cognitive Counseling Reduces Drinking Expectancy Among Men Who Have Sex with Men and Transgender Women in Lima, Peru: A Pilot Randomized Controlled Trial.","Personalized cognitive counseling (PCC) is an evidence-based intervention designed to modify HIV-related risk behavior. We assessed the impact of PCC on sexual behavior, drinking expectancy, and incidence of sexually transmitted infections (STIs) in a 6-month randomized controlled trial among 153 HIV-uninfected men who have sex with men (MSM) and transgender women (TW) in Peru. Study retention was ≥ 90%, with three HIV infections (3 Control) and 19 cases of GC/CT (10 Control, 9 PCC) at 6 months. There was a decline in condomless receptive anal intercourse in the Control (0.74, 95% CI 0.60-0.91; p < 0.01) and PCC arms (0.72, 0.55-0.94; p = 0.02) at 6-month follow-up. There was a decrease in drinking expectancy at 6 months among participants endorsing alcohol use in the PCC arm (0.89, 0.83-0.96; p < 0.01), versus no change in the Control arm (0.98, 0.92-1.04; p = 0.54). PCC was efficacious in reducing drinking expectancy and HIV risk among MSM and TW in Peru.",2020,"There was a decline in condomless receptive anal intercourse in the Control (0.74, 95% CI 0.60-0.91; p < 0.01) and PCC arms (0.72, 0.55-0.94; p = 0.02) at 6-month follow-up.","['Who Have Sex with Men and Transgender Women in Lima, Peru', '153 HIV-uninfected men who have sex with men (MSM) and transgender women (TW) in Peru', 'Men']","['Personalized Cognitive Counseling', 'PCC', 'Personalized cognitive counseling (PCC']","['sexual behavior, drinking expectancy, and incidence of sexually transmitted infections (STIs', 'drinking expectancy', 'condomless receptive anal intercourse', 'Drinking Expectancy', 'drinking expectancy and HIV risk']","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",153.0,0.085945,"There was a decline in condomless receptive anal intercourse in the Control (0.74, 95% CI 0.60-0.91; p < 0.01) and PCC arms (0.72, 0.55-0.94; p = 0.02) at 6-month follow-up.","[{'ForeName': 'R Colby', 'Initials': 'RC', 'LastName': 'Passaro', 'Affiliation': 'Department of Emergency Medicine, Los Angeles County + University of Southern California Medical Center, Los Angeles, CA, USA. ryan.c.passaro@vanderbilt.edu.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Chávez-Gomez', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Castañeda-Huaripata', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Williams', 'Initials': 'W', 'LastName': 'Gonzales-Saavedra', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Beymer', 'Affiliation': 'Department of Community Health Sciences, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Eddy R', 'Initials': 'ER', 'LastName': 'Segura', 'Affiliation': 'South American Program in HIV Prevention Research, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Nanclares', 'Affiliation': 'Alliance Health Project, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dilley', 'Affiliation': 'Department of Psychiatry, University of California San Francisco School of Medicine, San Francisco, CA, USA.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Cabello', 'Affiliation': 'Asociación Civil Via Libre, Lima, Peru.'}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Clark', 'Affiliation': 'South American Program in HIV Prevention Research, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02882-6']
918,31150916,Brazil nut intake increases circulating miR-454-3p and miR-584-5p in obese women.,"The Brazil nut is an excellent source of selenium (Se), an essential micronutrient for human health. In this study, we hypothesized that Brazil nut intake modulates circulating microRNAs (miRNAs) in obese women and aimed to evaluate the effects of this nut intake on circulating miRNAs in women with obesity or metabolic syndrome (MetS). A randomized controlled clinical trial was conducted on 54 subjects recruited from the Clinical Hospital in São Paulo, Brazil. Patients were randomly assigned to 2 groups: a Brazil nut group (BN group, n = 29) and a control group (CO group, n = 25); both were monitored for 2 months. BN group members were instructed to consume 1 Brazil nut (approximately 1261 μg/Se) per day; CO group members were instructed not to consume any. Biochemical parameters related to Se status and 25 circulating miRNAs in plasma were evaluated in all patients both at baseline and after 2 months. Expression levels of 2 miRNAs (miR-454-3p and miR-584-5p) were significantly increased after Brazil nut intake. To investigate the effect of MetS on circulating miRNAs at baseline, we performed comparisons between women with MetS (n = 23) and women without MetS (others, n = 31). Circulating miR-375 levels were significantly lower (P = .012) in women with MetS. In conclusion, our findings suggested that a daily intake of 1 Brazil nut increased circulating miR-454-3p and miR-584-5p expression levels in obese women, and our network analysis indicated a link between Se intake, vitamin D metabolism, and calcium homeostasis.",2019,Circulating miR-375 levels were significantly lower (P = .012) in women with MetS.,"['women with MetS (n\u202f=\u202f23) and women without MetS (others, n\u202f=\u202f31', 'obese women', 'women with MetS', '54 subjects recruited from the Clinical Hospital in São Paulo, Brazil', 'women with obesity or metabolic syndrome (MetS']","['Brazil nut', 'Brazil nut group (BN group, n\u202f=\u202f29) and a control group (CO', 'Brazil nut intake']","['Se status and 25 circulating miRNAs in plasma', 'Circulating miR-375 levels', 'Expression levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0440287', 'cui_str': 'Brazil nut (substance)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",54.0,0.0848921,Circulating miR-375 levels were significantly lower (P = .012) in women with MetS.,"[{'ForeName': 'Bruna Zavarize', 'Initials': 'BZ', 'LastName': 'Reis', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Science, University of São Paulo, São Paulo, Brazil. Electronic address: brunareis@usp.br.'}, {'ForeName': 'Graziela Biude Silva', 'Initials': 'GBS', 'LastName': 'Duarte', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Science, University of São Paulo, São Paulo, Brazil. Electronic address: gbiude@usp.br.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Vargas-Mendez', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Science, University of São Paulo, São Paulo, Brazil. Electronic address: evargas@usp.br.'}, {'ForeName': 'Ludmila Rodrigues Pinto', 'Initials': 'LRP', 'LastName': 'Ferreira', 'Affiliation': 'RNA Systems Biology Laboratory (RSBL), Department of Morphology, Institute of Biological Sciences (ICB), Federal University of Minas Gerais (UFMG). Electronic address: ludmila@icb.ufmg.br.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Barbosa', 'Affiliation': 'Department of Clinical, Toxicological and Bromatological Analysis, Faculty of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo. Electronic address: fbarbosa@fcfrp.usp.br.'}, {'ForeName': 'Cintia', 'Initials': 'C', 'LastName': 'Cercato', 'Affiliation': 'Division of Endocrinology and Metabolism, Clinical Hospital, School of Medicine, University of São Paulo, São Paulo, Brazil. Electronic address: ccercato@netpoint.com.br.'}, {'ForeName': 'Marcelo Macedo', 'Initials': 'MM', 'LastName': 'Rogero', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, São Paulo, Brazil; Food Research Center (FoRC), CEPID-FAPESP, Research Innovation and Dissemination Centers São Paulo Research Foundation, São Paulo 05468-140, Brazil. Electronic address: mmrogero@usp.br.'}, {'ForeName': 'Silvia Maria Franciscato', 'Initials': 'SMF', 'LastName': 'Cozzolino', 'Affiliation': 'Department of Food and Experimental Nutrition, Faculty of Pharmaceutical Science, University of São Paulo, São Paulo, Brazil. Electronic address: smfcozzo@usp.br.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2019.05.004']
919,31804698,The Effect of Botulinum Toxin Injection into the Common Extensor Tendon in Patients with Chronic Lateral Epicondylitis: A Randomized Trial.,"BACKGROUND


Botulinum toxin (BTX) is widely used for pain control in various musculoskeletal disorders.
OBJECTIVES


We evaluated the analgesic effect of botulinum toxin type A (BTX-A) in chronic lateral epicondylitis and compared the effect between 10 and 50 IU of BTX-A.
METHODS


Sixty subjects with chronic lateral epicondylitis were included and underwent a BTX-A injection in the common extensor tendon. The subjects were randomly allocated into two groups: the small-dose group (SD group; 30 subjects, 10 IU) and large-dose group (LD group; 30 subjects, 50 IU). Treatment outcomes were evaluated by measuring the pain level using the numeric rating scale (NRS) and measuring grip strength before and one, two, three, four, five, and six months after treatment.
RESULTS


Subjects in both groups showed a significant decrease in NRS scores at all evaluation time points after treatment. The reduction in NRS scores was significantly greater in the LD group at one, two, three, and four months after treatment. Six months after treatment, 19 subjects (63.3%) in the SD group and 21 (70%) in the LD group reported successful pain relief (pain relief ≥50%). The rate of successful pain relief was not significantly different between the two groups. Grip strength was more increased in the LD group at one, two, three, four, and six months after treatment.
CONCLUSIONS


BTX-A injection into the common extensor tendon can be a good treatment option for chronic lateral epicondylitis. The 50-IU BTX-A injection achieved a better outcome than the 10-IU injection.",2020,"Grip strength was more increased in the LD group at one, two, three, four, and six months after treatment.
","['chronic lateral epicondylitis', 'Sixty subjects with chronic lateral epicondylitis', 'Patients with Chronic Lateral Epicondylitis']","['BTX-A injection', 'Botulinum Toxin Injection', 'Botulinum toxin (BTX', 'botulinum toxin type A (BTX-A']","['pain level using the numeric rating scale (NRS) and measuring grip strength', 'successful pain relief', 'Grip strength', 'rate of successful pain relief', '50-IU BTX', 'NRS scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0222045'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.0659534,"Grip strength was more increased in the LD group at one, two, three, four, and six months after treatment.
","[{'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Madi Pain Management Center, Jeonju, Republic of Korea.'}, {'ForeName': 'Hyun Hee', 'Initials': 'HH', 'LastName': 'Choi', 'Affiliation': 'Madi Research and Development Center, Jeonju, Republic of Korea.'}, {'ForeName': 'Min Cheol', 'Initials': 'MC', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation Medicine, College of Medicine, Yeungnam University, Daegu, Republic of Korea.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz323']
920,24283172,The effects of hormone therapy on ischemia modified albumin and soluble CD40 ligand levels in obese surgical menopausal women.,"PURPOSE


To determine the effects of hormone therapy (HT) on ischemia modified albumin (IMA) and soluble (s)CD40 ligand in obese surgical menopausal women.
MATERIALS AND METHODS


A total of 52 obese surgical menopausal women with a body mass index (BMI) > 30 kg/m2 were admitted to the study. Twenty-seven women received estradiol hemihydrate two mg and 25 did not receive any menopausal therapy. At baseline and after three and six months of treatment, IMA and sCD40 ligand levels were measured.
RESULTS


There were no significant differences among the groups for any variables at baseline. No difference in change in the serum sCD40L levels was found in obese surgical menopausal women after three and six months of HT. Serum IMA levels were statistically lowered in obese women with HT after six months of treatment.
CONCLUSION


HT may have a beneficial reduction in IMA levels in obese surgical menopausal women.",2013,No difference in change in the serum sCD40L levels was found in obese surgical menopausal women after three and six months of HT.,"['BMI) > 30 kg/m2 were admitted to the study', '52 obese surgical menopausal women with a body mass index ', 'Twenty-seven women received', 'obese surgical menopausal women']","['estradiol hemihydrate two mg and 25 did not receive any menopausal therapy', 'HT', 'hormone therapy', 'hormone therapy (HT']","['ischemia modified albumin (IMA) and soluble', 'ischemia modified albumin and soluble CD40 ligand levels', 'IMA and sCD40 ligand levels', 'Serum IMA levels', 'IMA levels', 'serum sCD40L levels']","[{'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4319602', 'cui_str': '27'}]","[{'cui': 'C0772181', 'cui_str': 'Estradiol Hemihydrate'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}]","[{'cui': 'C3266190', 'cui_str': 'ischemia-modified serum albumin'}, {'cui': 'C0167627', 'cui_str': 'T-B Cell Activating Molecule'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",52.0,0.0641718,No difference in change in the serum sCD40L levels was found in obese surgical menopausal women after three and six months of HT.,"[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Osmanağaoğlu', 'Affiliation': 'Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynecology, Trabzon, Turkey. drmaosmanaga@gmail.com'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Karahan', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Aran', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Güven', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cora', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kopuz', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bozkaya', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
921,24703047,"Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study.","BACKGROUND


As new members of a drug class are developed, head-to-head trials are an important strategy to guide personalised treatment decisions. We assessed two glucagon-like peptide-1 receptor agonists, once-weekly albiglutide and once-daily liraglutide, in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs.
METHODS


We undertook this 32-week, open-label, phase 3 non-inferiority study at 162 sites in eight countries: USA (121 sites), Australia (9 sites), Peru (7 sites), Philippines (7 sites), South Korea (5 sites), UK (5 sites), Israel (4 sites), and Spain (4 sites). 841 adult participants (aged ≥18 years) with inadequately controlled type 2 diabetes and a BMI between 20 and 45 kg/m(2) were enrolled and randomised in a 1:1 ratio to receive albiglutide 30 mg once weekly titrated to 50 mg at week 6, or liraglutide 0·6 mg once daily titrated to 1·2 mg at week 1 and 1·8 mg at week 2. The randomisation schedule was generated by an independent randomisation team by the permuted block method with a fixed block size of 16. Participants and investigators were unmasked to treatment. The primary endpoint was change from baseline in HbA1c for albiglutide versus liraglutide, with a 95% CI non-inferiority upper margin of 0·3%. The primary analysis was by modified intention to treat. The study is registered with ClinicalTrials.gov, number NCT01128894.
FINDINGS


422 patients were randomly allocated to the albigultide group and 419 to the liraglutide group; 404 patients in the abliglutide group and 408 in the liraglutide group received the study drugs. The primary endpoint analysis was done on the modified intention-to-treat population, which included 402 participants in the albiglutide group and 403 in the liraglutide group. Model-adjusted change in HbA1c from baseline to week 32 was -0·78% (95% CI -0·87 to -0·69) in the albigludite group and -0·99% (-1·08 to -0·90) in the liraglutide group; treatment difference was 0·21% (0·08-0·34; non-inferiority p value=0·0846). Injection-site reactions occurred in more patients given albiglutide than in those given liraglutide (12·9% vs 5·4%; treatment difference 7·5% [95% CI 3·6-11·4]; p=0·0002), whereas the opposite was the case for gastrointestinal events, which occurred in 49·0% of patients in the liraglutide group versus 35·9% in the albiglutide group (treatment difference -13·1% [95% CI -19·9 to -6·4]; p=0·00013).
INTERPRETATION


Patients who received once-daily liraglutide had greater reductions in HbA1c than did those who received once-weekly albiglutide. Participants in the albiglutide group had more injection-site reactions and fewer gastrointestinal events than did those in the liraglutide group.
FUNDING


GlaxoSmithKline.",2014,"Participants in the albiglutide group had more injection-site reactions and fewer gastrointestinal events than did those in the liraglutide group.
","['patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7', '841 adult participants (aged ≥18 years) with inadequately controlled type 2 diabetes and a BMI between 20 and 45 kg/m(2', 'phase 3 non-inferiority study at 162 sites in eight countries: USA (121 sites), Australia (9 sites), Peru (7 sites), Philippines (7 sites), South Korea (5 sites), UK (5 sites), Israel (4 sites), and Spain (4 sites', 'group; 404 patients in the abliglutide group and 408 in the', 'patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs', '422 patients']","['glucagon-like peptide-1 receptor agonists, once-weekly albiglutide and once-daily liraglutide', 'albiglutide 30 mg once weekly titrated to 50 mg at week 6, or liraglutide 0·6 mg once daily titrated to 1·2 mg at week 1 and 1·8 mg at week 2', 'liraglutide', 'albigultide', 'albiglutide versus once-daily liraglutide']","['injection-site reactions and fewer gastrointestinal events', 'gastrointestinal events', 'change from baseline in HbA1c for albiglutide versus liraglutide', 'modified intention-to-treat population', 'Injection-site reactions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}]","[{'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C2607479', 'cui_str': 'albiglutide'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C2607479', 'cui_str': 'albiglutide'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",841.0,0.141179,"Participants in the albiglutide group had more injection-site reactions and fewer gastrointestinal events than did those in the liraglutide group.
","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'Florida Hospital Diabetes and Translational Research Institute, Sanford-Burnham Medical Research Institute, Orlando, FL, USA. Electronic address: richard.pratley@flhosp.org.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabeteszentrum Bad Lauterberg, Harz, Germany.'}, {'ForeName': 'Anthony H', 'Initials': 'AH', 'LastName': 'Barnett', 'Affiliation': 'Birmingham Heartlands Hospital, Birmingham, UK.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Feinglos', 'Affiliation': 'Duke University, Durham, NC, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ovalle', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.'}, {'ForeName': 'Illana', 'Initials': 'I', 'LastName': 'Harman-Boehm', 'Affiliation': 'Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Rhona', 'Initials': 'R', 'LastName': 'Scott', 'Affiliation': 'GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': 'GlaxoSmithKline, Upper Merion, PA, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes and Endocrine Center, Dallas, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(13)70214-6']
922,24992774,"Effects of laparoscopic ovarian endometriosis cystectomy combined with postoperative GnRH-a therapy on ovarian reserve, pregnancy, and outcome recurrence.","OBJECTIVE


The aim of this study was to investigate the impacts of laparoscopic ovarian endometriosis cystectomy combined with postoperative GnRH-a therapy on ovarian reserve, pregnancy outcome and recurrence.
MATERIALS AND METHODS


This was a prospective control study. The experimental group: 63 patients with combinations of laparoscopic bilateral ovarian endometrial cystectomies and gonadotropin-releasing hormone agonist (GnRH-a) treatment for three months.
CONTROL GROUP


62 patients with laparoscopic bilateral ovarian endometrial cystectomies. Benchmarks: the changes of follicle stimulating hormone (FSH) and FSH/luteinizing hormone (LH), etradiol (E2) in preoperative and postoperative three months or menstrual two to three days, menstrual two to three days after surgery, natural pregnancy, and cyst recurrence in 18th month during postoperative follow-up.
RESULTS


In experimental group after six months, the percentage of returned FSH accounted for 95.3% of normal range, in the control group it was 82.2%, and the difference was significant (p < 0.05). The natural pregnancy rate of preoperative infertility patients (57.1%) was higher than the control (36.8%) (p < 0.05). The recurrence rate of preoperative infertility patients (12.7%) was lower than the control (27.4%) (p < 0.05).
CONCLUSION


After bilateral laparoscopic ovarian endometrial cystectomy, an implement of GnRH-a therapy can improve the postoperative pregnancy rate, which changes with clinical stage and patient age, reduces ovarian recurrence, and its influence on ovarian reserve is lesser.",2014,"The recurrence rate of preoperative infertility patients (12.7%) was lower than the control (27.4%) (p < 0.05).
","['62 patients with laparoscopic bilateral ovarian endometrial cystectomies', '63 patients with combinations of laparoscopic bilateral ovarian endometrial cystectomies and']","['GROUP', 'gonadotropin-releasing hormone agonist (GnRH-a) treatment', 'laparoscopic ovarian endometriosis cystectomy combined with postoperative GnRH-a therapy', 'bilateral laparoscopic ovarian endometrial cystectomy']","['follicle stimulating hormone (FSH) and FSH/luteinizing hormone (LH), etradiol (E2', 'ovarian reserve, pregnancy, and outcome recurrence', 'percentage of returned FSH', 'recurrence rate of preoperative infertility patients', 'natural pregnancy rate of preoperative infertility patients', 'ovarian reserve, pregnancy outcome and recurrence', 'postoperative pregnancy rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0010651', 'cui_str': 'Cystectomy'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",63.0,0.144459,"The recurrence rate of preoperative infertility patients (12.7%) was lower than the control (27.4%) (p < 0.05).
","[{'ForeName': 'Xin-Hua', 'Initials': 'XH', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'AiXingZi', 'Initials': 'A', 'LastName': 'AiLi', 'Affiliation': ''}, {'ForeName': 'HaNiKeXi', 'Initials': 'H', 'LastName': 'TuerXun', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
923,31888709,"A randomised controlled trial of an exercise intervention promoting activity, independence and stability in older adults with mild cognitive impairment and early dementia (PrAISED) - A Protocol.","BACKGROUND


People with dementia progressively lose cognitive and functional abilities. Interventions promoting exercise and activity may slow decline. We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia. We successfully undertook a feasibility randomised controlled trial (RCT) to refine the intervention and research delivery. We are now delivering a multi-centred RCT to evaluate its clinical and cost-effectiveness.
METHODS


We will recruit 368 people with MCI or early dementia (Montreal Cognitive Assessment score 13-25) and a family member or carer from memory assessment clinics, other community health or social care venues or an online register (the National Institute for Health Research Join Dementia Research). Participants will be randomised to an individually tailored activity and exercise programme delivered using motivational theory to promote adherence and continued engagement, with up to 50 supervised sessions over one year, or a brief falls prevention assessment (control). The intervention will be delivered in participants' homes by trained physiotherapists, occupational therapists and therapy assistants. We will measure disabilities in activities of daily living, physical activity, balance, cognition, mood, quality of life, falls, carer strain and healthcare and social care use. We will use a mixed methods approach to conduct a process evaluation to assess staff training and delivery of the intervention, and to identify individual- and context-level mechanisms affecting intervention engagement and activity maintenance. We will undertake a health economic evaluation to determine if the intervention is cost-effective.
DISCUSSION


We describe the protocol for a multi-centre RCT that will evaluate the clinical and cost-effectiveness of a therapy programme designed to promote activity and independence amongst people living with dementia.
TRIAL REGISTRATION


ISRCTN, ISRCTN15320670. Registered on 4 September 2018.",2019,We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia.,"['people living with dementia', ""participants' homes by trained physiotherapists, occupational therapists and therapy assistants"", '368 people with MCI or early dementia (Montreal Cognitive Assessment score 13-25) and a family member or carer from memory assessment clinics, other community health or social care venues or an online register (the National Institute for Health Research Join Dementia Research', 'people with mild cognitive impairment (MCI) or early dementia', 'older adults with mild cognitive impairment and early dementia (PrAISED) - A Protocol']","['individually tailored activity and exercise programme delivered using motivational theory to promote adherence and continued engagement, with up to 50 supervised sessions over one year, or a brief falls prevention assessment (control', 'exercise intervention']","['disabilities in activities of daily living, physical activity, balance, cognition, mood, quality of life, falls, carer strain and healthcare and social care use']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0439045', 'cui_str': 'Memory assessment finding'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035168'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034380'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0419189', 'cui_str': 'Social care (regime/therapy)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.15019,We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia.,"[{'ForeName': 'Rupinder K', 'Initials': 'RK', 'LastName': 'Bajwa', 'Affiliation': 'Divison of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, NG7 2UH, UK. Rupinder.Bajwa@nottingham.ac.uk.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Goldberg', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Van der Wardt', 'Affiliation': 'Divison of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Burgon', 'Affiliation': 'Divison of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Di Lorito', 'Affiliation': 'Divison of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Godfrey', 'Affiliation': 'Patient and Public Involvement Collaborator, Nottingham, UK.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Dunlop', 'Affiliation': 'Patient and Public Involvement Collaborator, Nottingham, UK.'}, {'ForeName': 'Pip', 'Initials': 'P', 'LastName': 'Logan', 'Affiliation': 'Divison of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Masud', 'Affiliation': 'Divison of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gladman', 'Affiliation': 'Divison of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Smith', 'Affiliation': 'Mental Health Services for Older People, Nottinghamshire Healthcare NHS Foundation Trust, Highbury Hospital, Nottingham, NG6 9RD, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Hood-Moore', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Booth', 'Affiliation': 'Divison of Rehabilitation, Ageing and Wellbeing, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Das Nair', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, NG8 1BB, UK.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Pollock', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, NG7 2UH, UK.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Vedhara', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, NG7 2RD, UK.'}, {'ForeName': 'Rhiannon Tudor', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, LL57 2PZ, UK.'}, {'ForeName': 'Carys', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, LL57 2PZ, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Hoare', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health Clinical Trials Unit (NWORTH CTU), Bangor University, Bangor, LL57 2PZ, Wales, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health Clinical Trials Unit (NWORTH CTU), Bangor University, Bangor, LL57 2PZ, Wales, UK.'}, {'ForeName': 'Rowan H', 'Initials': 'RH', 'LastName': 'Harwood', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, NG7 2UH, UK.'}]",Trials,['10.1186/s13063-019-3871-9']
924,24707676,Difference in post-surgical reproductive prognosis between transcervical resection and transcervical incision of the septum.,"OBJECTIVE


This study aims to determine the difference between transcervical resection of septum (TCRS) and transcervical incision of septum (TCIS) in the improvement of reproductive prognosis.
STUDY DESIGN


Women with uterine septum in the Affiliated Hospital of Ningxia Medical University were retrospectively analyzed. A statistical method was used according to operative time, postoperative menstruation, postoperative pregnancy rate, postoperative term delivery rate, and so on.
RESULTS


Compared with TCRS, the TCIS method decreased operative time, blood loss, and consumption of uterus distension medium. No statistical difference was observed in operative complications between the two methods. After TCIS, the incidence of uterine adhesion was low and the degree of endometrial epithelialisation was high by hysteroscopy review. No statistical difference was observed in residual septum after the operation. The total pregnancy rate after TCIS was higher than that of TCRS. However, no statistical difference was observed in early and late pregnancy loss rates, preterm birth rate, and term birth rate.
CONCLUSION


TCIS exhibits advantages of decreasing operative time, blood loss, and consumption of uterus distension medium. TCIS can reduce the incidence of uterine adhesion and can promote endometrial epithelialisation, which are the key factors to increase pregnancy rate after operation.",2014,"However, no statistical difference was observed in early and late pregnancy loss rates, preterm birth rate, and term birth rate.
",['Women with uterine septum in the Affiliated Hospital of Ningxia Medical University'],"['transcervical resection of septum (TCRS) and transcervical incision of septum (TCIS', 'transcervical resection and transcervical incision of the septum', 'TCIS', 'TCRS']","['residual septum', 'operative time, blood loss, and consumption of uterus distension medium', 'total pregnancy rate after TCIS', 'operative time, postoperative menstruation, postoperative pregnancy rate, postoperative term delivery rate, and so on', 'degree of endometrial epithelialisation', 'uterine adhesion', 'early and late pregnancy loss rates, preterm birth rate, and term birth rate', 'operative complications', 'pregnancy rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0334029', 'cui_str': 'Epithelialization (morphologic abnormality)'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0233324', 'cui_str': 'Term Birth'}]",,0.0679694,"However, no statistical difference was observed in early and late pregnancy loss rates, preterm birth rate, and term birth rate.
","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Z N', 'Initials': 'ZN', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Ha', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
925,31800542,Randomized Clinical Trial: Crofelemer Treatment in Women With Diarrhea-Predominant Irritable Bowel Syndrome.,"INTRODUCTION


Crofelemer, the active compound purified from latex of Croton lechleri, has been shown to improve HIV and traveler's diarrhea and improve pain in women with irritable bowel syndrome-diarrhea (IBS-D). This trial evaluated the effect of crofelemer on abdominal pain in women with IBS-D.
METHODS


Women with IBS-D were randomized to crofelemer (125 mg) or placebo twice daily for 12 weeks. The primary efficacy endpoint was overall change in percentage of abdominal pain/discomfort-free days. Post hoc analysis for Food and Drug Administration (FDA) monthly responders was performed for stool consistency, abdominal pain, and combined stool consistency and abdominal pain.
RESULTS


A total of 240 women were enrolled. There was no significant difference in overall percentage of pain/discomfort-free day between the groups. In post hoc analysis, FDA abdominal pain monthly responders were significantly more likely during months 1 through 2 (58.3% vs 45.0%, P = 0.030) as well as during the entire 3 months (54.2% vs 42.5%, P = 0.037) in the crofelemer group when compared with placebo. However, there was no significant difference in the percentage of FDA stool consistency monthly responders or combined stool consistency and pain monthly responders between the groups. Crofelemer had a safety profile similar to placebo.
DISCUSSION


Crofelemer did not significantly improve abdominal pain over placebo by the primary endpoint. However, it did based on the FDA abdominal pain monthly responder endpoint. This suggests that crofelemer may have a role in the treatment of abdominal pain associated with IBS-D. Further studies are warranted to evaluate the potential of crofelemer as a visceral analgesic.",2019,There was no significant difference in overall percentage of pain/discomfort-free day between the groups.,"['women with IBS-D', 'Women With Diarrhea-Predominant Irritable Bowel Syndrome', 'women with irritable bowel syndrome-diarrhea (IBS-D', 'A total of 240 women were enrolled', 'Women with IBS-D']",['placebo'],"['stool consistency, abdominal pain, and combined stool consistency and abdominal pain', 'percentage of FDA stool consistency monthly responders or combined stool consistency and pain monthly responders', 'percentage of abdominal pain/discomfort-free days', 'overall percentage of pain/discomfort', 'FDA abdominal pain monthly responders', 'abdominal pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",240.0,0.256371,There was no significant difference in overall percentage of pain/discomfort-free day between the groups.,"[{'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Nee', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Salley', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Ludwig', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sommers', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ballou', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Takazawa', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Duehren', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Iturrino', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Katon', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Ha-Neul', 'Initials': 'HN', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Rangan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Lembo', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000110']
926,24283160,Nonhormonal management of postmenopausal women: effects of a red clover based isoflavones supplementation on climacteric syndrome and cardiovascular risk serum profile.,"PURPOSE OF INVESTIGATION


The aim of this prospective randomized study was to evaluate a red clover based isoflavones supplementation in the treatment of climacteric syndrome and its effects on cardiovascular risk serum profile.
MATERIALS AND METHODS


The study included 150 healthy postmenopausal women that were randomly assigned to receive phytoestrogens tablets, amounting in a total daily intake of 60.8 mg red clover isoflavones plus 19.2 mg soy isoflavones (n = 75), or placebo (n = 75). The authors evaluated teh following: daily number of hot flushes and Kupperman Index at baseline and after one and three months; serum total, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, triglycerides, prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen, and antithrombin III (ATIII) at baseline and after three and six months.
RESULTS


One hundred twenty-eight patients completed the study: 67 in the active group and 61 in the placebo group. The treatment led to a progressive significant reduction (p < 0.05) of the number of hot flushes in the active group compared to placebo already after one month, while Kupperman Index was statistically reduced after three months. No significant variation in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, PT, PTT, fibrinogen, and ATIII were found.
CONCLUSION


The present findings suggest that a red clover based isoflavones supplementation in healthy postmenopausal women is promptly effective on climacteric syndrome, improves neurovegetative symptoms, safe on cardiovascular risk serum profile, and does not modify lipids and coagulation.",2013,"The treatment led to a progressive significant reduction (p < 0.05) of the number of hot flushes in the active group compared to placebo already after one month, while Kupperman Index was statistically reduced after three months.","['postmenopausal women', 'healthy postmenopausal women', 'One hundred twenty-eight patients completed the study: 67 in the active group and 61 in the placebo group', '150 healthy postmenopausal women']","['phytoestrogens tablets, amounting in a total daily intake of 60.8 mg red clover isoflavones plus 19.2 mg soy isoflavones', 'placebo', 'red clover based isoflavones supplementation']","['cardiovascular risk serum profile', 'Kupperman Index', 'serum total, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, triglycerides, prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen, and antithrombin III (ATIII', 'total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, PT, PTT, fibrinogen, and ATIII', 'number of hot flushes', 'climacteric syndrome and cardiovascular risk serum profile', 'neurovegetative symptoms, safe on cardiovascular risk serum profile']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0330783', 'cui_str': 'Clover, Red'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin Time'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",150.0,0.205678,"The treatment led to a progressive significant reduction (p < 0.05) of the number of hot flushes in the active group compared to placebo already after one month, while Kupperman Index was statistically reduced after three months.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mainini', 'Affiliation': '""San Leonardo"" Hospital, Castellammare di Stabia, Naples, Italy. giampaolomainini@libero.it'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Torella', 'Affiliation': ''}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Di Donna', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Esposito', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ercolano', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Correa', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cucinella', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Stradella', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Luisi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Basso', 'Affiliation': ''}, {'ForeName': 'F V', 'Initials': 'FV', 'LastName': 'Cerreto', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cicatiello', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Matteo', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'De Franciscis', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
927,24283167,"Maternal and umbilical cord oxygen content and acid-base balance in relation to general, epidural or subarachnoid anesthesia for term elective cesarean section.","PURPOSE


To compare maternal and neonatal oxygenation and acid-base status after elective cesarean section (CS) under different anesthetic techniques.
MATERIALS AND METHODS


Three hundred and eighty parturients undergoing elective cesarean section were randomly assigned to receive general (GA, n =140), epidural (EA, n = 117) or subarachnoid anesthesia (SA, n =123). Blood gases, oxygen content, and acid-base status parameters were measured in maternal artery and umbilical cord vessels. Neonatal Apgar scores were also recorded.
RESULTS


Umbilical artery pH, HCO3-, and actual base excess (ABE) were significantly higher in the GA compared to SA group (p < 0.001, p < 0.05, andp < 0.05, respectively). Umbilical vein ABE was lower in the SA compared to GA and EA groups (p < 0.05). Oxygen content in maternal artery was higher in the GA and EA groups compared to the SA group (p < 0.05). Neonatal oxygen content in both cord vessels was higher in the GA group compared to EA and SA groups (p < 0.05). Umbilical venous-arterial difference of PO2, oxygen content, and Apgar scores did not differ significantly among groups.
CONCLUSION


Neonatal oxygenation and acid-base status values were better preserved when GA was administered for elective CS compared to regional modalities. Apgar scores and neonatal outcomes were not affected by the anesthetic technique.",2013,Neonatal oxygen content in both cord vessels was higher in the GA group compared to EA and SA groups (p < 0.05).,"['Three hundred and eighty parturients undergoing elective cesarean section', 'term elective cesarean section']","['epidural or subarachnoid anesthesia', 'elective cesarean section (CS', 'epidural (EA, n = 117) or subarachnoid anesthesia']","['Umbilical venous-arterial difference of PO2, oxygen content, and Apgar scores', 'Neonatal oxygen content in both cord vessels', 'Maternal and umbilical cord oxygen content and acid-base balance', 'Oxygen content in maternal artery', 'Umbilical artery pH, HCO3-, and actual base excess (ABE', 'Neonatal Apgar scores', 'Apgar scores and neonatal outcomes', 'Umbilical vein ABE', 'Blood gases, oxygen content, and acid-base status parameters']","[{'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C1283004', 'cui_str': 'PO>2< measurement (procedure)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0001117', 'cui_str': 'Acid-Base Balance'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0041632', 'cui_str': 'Umbilical Arteries'}, {'cui': 'C0201985', 'cui_str': 'Base excess - observation'}, {'cui': 'C0221313', 'cui_str': 'Fetal umbilical vein structure'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",380.0,0.108995,Neonatal oxygen content in both cord vessels was higher in the GA group compared to EA and SA groups (p < 0.05).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Staikou', 'Affiliation': '1st Department of Anesthesiology, Aretaieio Hospital, Medical School, University of Athens, Athens, Greece. c_staikou@yahoo.gr'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tsaroucha', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vakas', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Salakos', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hasiakos', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Panoulis', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Petropoulos', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
928,25571338,Classifying and predicting endurance outcomes of α2-adrenergic agonist intervention in spinal cord injury.,"Spinal cord injury (SCI) is a traumatic condition that can lead to both functional and neuromuscular impairments. Spasticity in the muscles surrounding the ankle joint caused by hypertonia is often reported as a complication. We investigated whether a pharmacological intervention using Tizanidine, an anti-spastic medication acting as an α2-adrenergic agonist, could lead to improvements in walking endurance. We placed subjects on a 4-week program and measured the change in clinical measures of walking speed, endurance, and mobility. We used growth mixture modeling (GMM) to class subjects into groups based on recovery patterns. Two classes of recovery were found by GMM: high and low functioning. Radom coefficient regression (RCR) was then used to identify significant changes over time. Statistically significant improvements in walking endurance were shown for the high functioning group. However, a small number of subjects in the high functioning group showed improvement greater than the smallest real difference (SRD), which indicates a clinical significance as well. We also investigated the extent to which these recovery patterns can be predicted using baseline measures. Baseline walking endurance was found to be a robust predictor of recovery in walking endurance. Subjects that began the intervention with already higher endurance showed a greater chance of improvement in endurance over time. This information could potentially be used as a fast and reliable assessment tool for clinicians to predict which patient can benefit the most from this intervention prior to prescribing the medication, and thus optimizing cost and resources. Our findings demonstrate that these techniques can be used to characterize and predict the progress of changes to functional impairments due to various types of intervention.",2014,Statistically significant improvements in walking endurance were shown for the high functioning group.,['spinal cord injury'],"['α2-adrenergic agonist intervention', 'growth mixture modeling (GMM', 'Tizanidine']","['clinical measures of walking speed, endurance, and mobility', 'walking endurance']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}]","[{'cui': 'C0001648', 'cui_str': 'Adrenomimetics'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0061773', 'cui_str': 'GMM'}, {'cui': 'C0146011', 'cui_str': 'tizanidine'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",,0.0237505,Statistically significant improvements in walking endurance were shown for the high functioning group.,"[{'ForeName': 'Geoffrey L', 'Initials': 'GL', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Lynsey D', 'Initials': 'LD', 'LastName': 'Duffell', 'Affiliation': ''}, {'ForeName': 'Mehdi M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2014.6944970']
929,25571596,Choice stepping reaction time test using exergame technology for fall risk assessment in older people.,"Accidental falls remain an important problem in older people. Stepping is a common task to avoid a fall and requires good interplay between sensory functions, central processing and motor execution. Increased choice stepping reaction time has been associated with recurrent falls in older people. The aim of this study was to examine if a sensor-based Exergame Choice Stepping Reaction Time test can successfully discriminate older fallers from non-fallers. The stepping test was conducted in a cohort of 104 community-dwelling older people (mean age: 80.7 ± 7.0 years). Participants were asked to step laterally as quickly as possible after a light stimulus appeared on a TV screen. Spatial and temporal measurements of the lower and upper body were derived from a low-cost and portable 3D-depth sensor (i.e. Microsoft Kinect) and 3D-accelerometer. Fallers had a slower stepping reaction time (970 ± 228 ms vs. 858 ± 123 ms, P = 0.001) and a slower reaction of their upper body (719 ± 289 ms vs. 631 ± 166 ms, P = 0.052) compared to non-fallers. It took fallers significantly longer than non-fallers to recover their balance after initiating the step (2147 ± 800 ms vs. 1841 ± 591 ms, P = 0.029). This study demonstrated that a sensor-based, low-cost and easy to administer stepping test, with the potential to be used in clinical practice or regular unsupervised home assessments, was able to identify significant differences between performances by fallers and non-fallers.",2014,"Fallers had a slower stepping reaction time (970 ± 228 ms vs. 858 ± 123 ms, P = 0.001) and a slower reaction of their upper body (719 ± 289 ms vs. 631 ± 166 ms, P = 0.052) compared to non-fallers.","['104 community-dwelling older people (mean age: 80.7 ± 7.0 years', 'older people', 'older fallers from non-fallers']",['sensor-based Exergame Choice Stepping Reaction Time test'],"['slower stepping reaction time', 'slower reaction of their upper body']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}]",,0.0233624,"Fallers had a slower stepping reaction time (970 ± 228 ms vs. 858 ± 123 ms, P = 0.001) and a slower reaction of their upper body (719 ± 289 ms vs. 631 ± 166 ms, P = 0.052) compared to non-fallers.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ejupi', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Brodie', 'Affiliation': ''}, {'ForeName': 'Yves J', 'Initials': 'YJ', 'LastName': 'Gschwind', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schoene', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lord', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Delbaere', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2014.6945228']
930,32425062,The predictive value of procalcitonin in ventilator-associated pneumonia after cardiac valve replacement.,"This study aimed to evaluate the predictive value of procalcitonin (PCT) in ventilator-associated pneumonia (VAP) after cardiac valve replacement. A total of 80 patients who underwent cardiac valve replacement in our department were enrolled in this study. Of these patients,40 were diagnosed with VAP and assigned to the observation group, while the other 40 patients not diagnosed with VAP were assigned to the control group. The changes in serum PCT, white blood cell count and C-reactive protein (CRP) were observed before each operation (T0), on the first day after the operation (T1), the second day after the operation (T2) and the third day after the operation (T3). After the operation, the serum PCT in the observation group was significantly higher than those at different time points after the operation, and also significantly higher than those in the control group ( p  < .05). In the control group, PCT was significantly higher after the operation than before the operation ( p  < .05), but the differences among the different postoperative time points were not statistically significant ( p  > .05). In the two groups, the white blood cell count and CRP were significantly higher after the operation than before the operation ( p  < .05), but the differences between the two groups were not statistically significant ( p  > .05). Serum PCT is an early, sensitive and highly specific high-risk monitoring index and has an early prediction value for VAP after cardiac valve replacement.",2020,"Serum PCT is an early, sensitive and highly specific high-risk monitoring index and has an early prediction value for VAP after cardiac valve replacement.","['ventilator-associated pneumonia (VAP) after cardiac valve replacement', '80 patients who underwent cardiac valve replacement in our department were enrolled in this study', '40 patients not diagnosed with VAP', 'ventilator-associated pneumonia after cardiac valve replacement']",['procalcitonin (PCT'],"['serum PCT', 'serum PCT, white blood cell count and C-reactive protein (CRP', 'PCT', 'white blood cell count and CRP']","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0072027', 'cui_str': 'Procalcitonin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",80.0,0.0145082,"Serum PCT is an early, sensitive and highly specific high-risk monitoring index and has an early prediction value for VAP after cardiac valve replacement.","[{'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Song', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ji-Wei', 'Initials': 'JW', 'LastName': 'Gu', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yu-Jing', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}]",Scandinavian journal of clinical and laboratory investigation,['10.1080/00365513.2020.1762242']
931,25428747,Asymmetric dimethylarginine and endothelial progenitor cells after renal transplantation: the effect of exercise training.,"Level of asymmetric dimethylarginine (ADMA) is elevated and endothelial progenitor cells (EPC) and stem cells (SC) are decreased in patients undergoing renal transplantation (Tx) and may contribute to cardiovascular complications. We tested the hypothesis that ADMA, EPC and SC can be influenced with regular physical exercise early after Tx. Blood samples of ADMA, EPC, SC, adipocytokines and metabolic parameters were randomly obtained from 50 transplant patients before and 6 months after exercise program (Group I). Fifty age, sex, HLA typing, duration of dialysis and immunosupression regimen-matched non exercising transplant were examined as controls (Group II). After 6 months, in Group I ADMA decreased (3.50+/-0.45 vs 2.11+/-0.35 micromol/l, P<0.01) and was lower comparing to Group II (P<0.01), SC and EPC also decreased (2816+/-600 vs 2071+/-480 cells/ml resp. 194+/-87 to 125+/-67 cells/ml, P<0.02). Next changes in Group I: adiponectin (P<0.01), leptin (P<0.01), resistin (P<0.02). Visfatin, blood lipids, HbA1c, insulin and blood pressure were also influenced by training program (P<0.05).",2014,"Next changes in Group I: adiponectin (P<0.01), leptin (P<0.01), resistin (P<0.02).","['patients undergoing renal transplantation (Tx', 'Fifty age, sex, HLA typing, duration of dialysis and immunosupression regimen-matched non exercising transplant', 'renal transplantation']",['exercise training'],"['Visfatin, blood lipids, HbA1c, insulin and blood pressure', 'endothelial progenitor cells (EPC) and stem cells (SC', 'Level of asymmetric dimethylarginine (ADMA', 'Blood samples of ADMA, EPC, SC, adipocytokines and metabolic parameters', 'Asymmetric dimethylarginine and endothelial progenitor cells']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0242318', 'cui_str': 'HLA Typing'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0068707', 'cui_str': 'Visfatin'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0067385', 'cui_str': 'asymmetric dimethylarginine'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",50.0,0.017004,"Next changes in Group I: adiponectin (P<0.01), leptin (P<0.01), resistin (P<0.02).","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Teplan', 'Affiliation': 'Department of Nephrology, Transplant Center, Institute for Clinical and Experimental Medicine, Prague, Czech Republic. vladimir.teplan@ikem.cz.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Králová Lesná', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Piťha', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mahrová', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Racek', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Valkovský', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sekerková', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Štollová', 'Affiliation': ''}]",Physiological research,[]
932,25134285,Sublingual misoprostol is better for cervical ripening prior to hysteroscopy in post-menopausal women.,"BACKGROUND


The aim of the present study was to evaluate the efficacy of misoprostol administered sublingually, vaginally or rectally on cervical ripening before hysterescopic surgery in post-menopausal women.
MATERIALS AND METHODS


Post-menopausal women were randomised to receive either 400 ug of misoprostol, administered sublingually, vaginally or rectally six hours and 12 hours prior to operative hysterescopy.
RESULTS


Patients were randomized to receive receive sublingual (n = 30), rectal (n = 30) or vaginal (n = 30) misoprostol. The control group did not receive misoprostol (n = 30). The four groups were comparable in terms of preoperative cervical width after misoprostol administration. The mean cervical widths for control group was 9.0 +/- 1.1 mm and the mean post-treatment cervical widths for the sublingual, vaginal, and rectal groups were 7.1 +/- 1.1 mm, 8.9 +/- 1.3 mm, and 8.6 +/- 1.5 mm, respectively. The cervical widths of sublingual group were significantly different from control, vaginal; and rectal groups (p < 0.001).
CONCLUSION


Four hundred micrograms of sublingual misoprostol, 12 and six hours prior to operative hysteroscopy has a significant cervical ripening effect compared with vaginal, rectal, and control groups in post-menopausal women.",2014,"The cervical widths of sublingual group were significantly different from control, vaginal; and rectal groups (p < 0.001).
","['post-menopausal women', 'Post-menopausal women']","['sublingual misoprostol', 'Sublingual misoprostol', 'sublingual', '400 ug of misoprostol', 'misoprostol']","['mean post-treatment cervical widths', 'cervical widths', 'cervical ripening effect', 'mean cervical widths', 'preoperative cervical width']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0600454', 'cui_str': 'Ripenings, Cervical'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",,0.0837207,"The cervical widths of sublingual group were significantly different from control, vaginal; and rectal groups (p < 0.001).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kale', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Terzi', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kale', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
933,25134291,Risk of recurrent menorrhagia after hydrothermoablation: role of GnRH analogues neoadjuvant treatment in long-term successful rate.,"OBJECTIVE


To evaluate the long-term effectiveness of presurgical therapy with GnRH analogues in patients who underwenthydrothermal endometrial ablation (HTA) for menorrhagia and assess the relationship between sonographically measured myometrium thickness and pelvic pain.
MATERIALS AND METHODS


A prospective randomized control study comparing 15 women (Group A) with presurgical subcutaneous triptorelin depot injection before HTA with controls (Group B, n = 15). Inclusion criteria were: recurrent menorrhagia, uterus length < 12 cm, no previous hormonal therapy for at least six month, and family plan completed. Student's t test was applied, as appropriate, to compare continuous variables. Proportion were compared with chi-squared.
RESULTS


After 12 months of follow-up, Group A showed a significantly lower (0% vs 20%; p = 0.03) failure rate after hydrothermoablation than the Group B and a generally higher successful rate at 24 and 48 months. The discomfort, evaluated with VAS, showed a mean value of 47.6 +/- 15.9 +/- SD); 96.7% of women reported a mild-moderate postoperative pain. No perioperative and late complications were recorded.
CONCLUSIONS


Presurgical treatment with GnRH analogues seems to improve long-term efficacy of HTA. Perioperative pelvic pain seems to not be affected by myometrium thickness.",2014,"No perioperative and late complications were recorded.
","['recurrent menorrhagia after hydrothermoablation', '15 women (Group A) with presurgical subcutaneous triptorelin depot injection before HTA with controls (Group B, n = 15', 'patients who underwenthydrothermal endometrial ablation (HTA) for menorrhagia', 'Inclusion criteria were: recurrent menorrhagia, uterus length < 12 cm, no previous hormonal therapy for at least six month, and family plan completed']",['presurgical therapy with GnRH analogues'],"['Perioperative pelvic pain', 'perioperative and late complications', 'successful rate', 'failure rate', 'mild-moderate postoperative pain']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341803', 'cui_str': 'Endometrial Ablation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}]","[{'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",,0.0582359,"No perioperative and late complications were recorded.
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Litta', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Saccardi', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tommasi', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Di Giuseppe', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Delli Carpini', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ciavattini', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
934,25134294,Effectiveness of pericervical tourniquet by Foley catheter reducing blood loss at abdominal myomectomy.,"OBJECTIVE


To evaluate effectivenes of pericervical tourniquet by Foley catheter reducing blood loss at abdominal myomectomy.
MATERIALS AND METHODS


Retrospective chart review of 67 cases, with symptomatic myoma uteri and undertaken abdominal myomectomy, was performed. Myomectomy was performed in Group 1 (n = 34) by Foley catheter tourniquet around both uterin vessels and in Group 2 (n = 33) the tourniquet was not performed.
RESULTS


The average blood loss during myomectomy was 286.4 +/- 137.5 ml for the tourniquet group and 673.8 +/- 172.3 ml for the control group. Postoperative blood transfusion was necessary in two patients from the control group. Technique significantly reduced the intraoperative blood loss and postoperative hemoglobin fall in patients. No serious complications occured on account of the tourniquet technique.
CONCLUSIONS


The pericervical tourniquet by Foley catheter is a safe and effective method for reducing blood loss during abdominal myomectomy, although it should be evaluated in a randomized controlled trial.",2014,"No serious complications occured on account of the tourniquet technique.
","['Retrospective chart review of 67 cases, with symptomatic myoma uteri and undertaken abdominal myomectomy, was performed', 'at abdominal myomectomy']","['pericervical tourniquet by Foley catheter', 'Foley catheter tourniquet around both uterin vessels', 'Myomectomy']","['average blood loss', 'blood loss', 'intraoperative blood loss and postoperative hemoglobin fall', 'Postoperative blood transfusion']","[{'cui': 'C0541653', 'cui_str': 'Chart review'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0195309', 'cui_str': 'Uterine Myomectomy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0179804'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0195309', 'cui_str': 'Uterine Myomectomy'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]",,0.0628528,"No serious complications occured on account of the tourniquet technique.
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Alptekin', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Efe', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
935,24779241,The influence of mifepristone to caspase 3 expression in adenomyosis.,"OBJECTIVE


To discuss the influence of mifepristone to caspase 3 expression in adenomyosis tissue.
MATERIALS AND METHODS


Sixty patients were equally divided into four groups. Groups 1, 2, and 3 were treated with 5, 10, and 15 mg mifepristone, respectively and group 4 was treated with placebo. The expression of caspase 3 was examined by immunohistochemical method in both eutopic and ectopic endometria of the 40 cases.
RESULTS


Compared with placebo group, the expression of caspase 3 in both eutopic endometrium and ectopic endometrium in the three treatment groups was significantly increased. There was no difference in the expression of caspase 3 in both eutopic and ectopic endometria between the ten and 25 mg treatment groups, while both the ten and 25 mg treatment groups had a higher expression intensity of caspase 3 in both eutopic and ectopic endometria, compared with the five mg treatment group (p < 0.01).
CONCLUSION


Mifepristone can increase the expression of caspase 3 in both eutopic and ectopic endometria and initiate cell apoptosis in both eutopic and ectopic endometria. Therefore mifepristone can effectively inhibit the emergence and development of adenomyosis.",2014,Mifepristone can increase the expression of caspase 3 in both eutopic and ectopic endometria and initiate cell apoptosis in both eutopic and ectopic endometria.,['Sixty patients'],"['placebo', 'Mifepristone', 'mifepristone']","['expression intensity of caspase 3 in both eutopic and ectopic endometria', 'expression of caspase 3 in both eutopic endometrium and ectopic endometrium', 'expression of caspase 3 in both eutopic and ectopic endometria']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0291573', 'cui_str': 'CASP3'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}]",60.0,0.0168551,Mifepristone can increase the expression of caspase 3 in both eutopic and ectopic endometria and initiate cell apoptosis in both eutopic and ectopic endometria.,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
936,24707675,Effects of long-term fasting on female hormone levels: Ramadan model.,"BACKGROUND


Ramadan fasting is a special model of hunger and particularly affects metabolic processes, including carbohydrate and lipid levels. Endocrine changes induced by Ramadan fasting are not well known.
OBJECTIVE


The aim of this article was to evaluate the changes in hormone levels in women before and after the special Muslim fasting period of Ramadan.
MATERIALS AND METHODS


This study was performed in 30 healthy women in Obstetrics and Gynecology department during the Ramadan month of2011. Patients during and after the first menstrual period had menstrual cycles fasting blood samples taken on the same days. Luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol (E2), testosterone, and prolactin (PRL) levels were determined.
RESULTS


Before and during fasting LH, FSH, E2, testosterone and PRL levels were not statistically different.
CONCLUSION


Despite the limited available studies on these subjects in women, effect of Ramadan fasting on hormone levels were found to be within the normal limits.",2014,"Before and during fasting LH, FSH, E2, testosterone and PRL levels were not statistically different.
","['female hormone levels', 'women before and after the special Muslim fasting period of Ramadan', '30 healthy women in Obstetrics and Gynecology department during the Ramadan month of2011']",[],"['hormone levels', 'fasting LH, FSH, E2, testosterone and PRL levels', 'Luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol (E2), testosterone, and prolactin (PRL) levels', 'menstrual cycles fasting blood samples']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0026870', 'cui_str': 'Muslims'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0587480', 'cui_str': 'Obstetrics and gynecology department (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",30.0,0.0228902,"Before and during fasting LH, FSH, E2, testosterone and PRL levels were not statistically different.
","[{'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Cağlayan', 'Affiliation': ''}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Göçmen', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Delibas', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
937,31881459,Effects of prenatal individualized mixed management on breastfeeding and maternal health at three days postpartum: A randomized controlled trial.,"BACKGROUND


Pregnant women with antenatal depression are more prone to postpartum depression and failure in breastfeeding than women without antenatal depression. The purpose of this study was to evaluate the effectiveness of a prenatal individualized mixed management intervention on breastfeeding and maternal physical and psychological status at three days postpartum.
METHODS


This randomized single-blind controlled trial was conducted from December 2017 to August 2018 with 182 primiparous women in Shanghai, China. Participants with Edinburgh Postnatal Depression Scale (EPDS) scores ≥9 were randomly allocated to the intervention group (n = 91) or control group (n = 91). The intervention group underwent a 4-session individualized mixed management intervention and the control group received usual care. Feeding patterns, Breastfeeding Self-Efficacy Scale (BSES), Infant Breastfeeding Assessment Scale (IBAS), and EPDS were used to measure the main outcomes. Two-tailed p-values of p < .05 were considered statistically significant.
RESULTS


The intervention group had significantly more effective breastfeeding behavior, better breastfeeding self-efficacy, more successful breastfeeding initiation, lower EPDS scores, more sleep time, and better appetite than the control group.
CONCLUSION


The prenatal individualized mixed management intervention demonstrated significant short-term improvement in breastfeeding and maternal physical and psychological health at three days postpartum.
TRIAL REGISTRATION


ChiCTR-IOR-17013761; December 7, 2017.",2020,"The intervention group had significantly more effective breastfeeding behavior, better breastfeeding self-efficacy, more successful breastfeeding initiation, lower EPDS scores, more sleep time, and better appetite than the control group.
","['December 2017 to August 2018 with 182 primiparous women in Shanghai, China', 'Pregnant women with antenatal depression', 'Participants with Edinburgh Postnatal Depression Scale (EPDS) scores ≥9']","['prenatal individualized mixed management', 'prenatal individualized mixed management intervention', '4-session individualized mixed management intervention and the control group received usual care']","['effective breastfeeding behavior, better breastfeeding self-efficacy, more successful breastfeeding initiation, lower EPDS scores, more sleep time, and better appetite', 'breastfeeding and maternal physical and psychological status', 'Feeding patterns, Breastfeeding Self-Efficacy Scale (BSES), Infant Breastfeeding Assessment Scale (IBAS), and EPDS', 'breastfeeding and maternal physical and psychological health', 'breastfeeding and maternal health']","[{'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score (observable entity)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1999013', 'cui_str': 'Normal breast feeding (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015748', 'cui_str': 'Feeding Patterns'}, {'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}]",,0.0671577,"The intervention group had significantly more effective breastfeeding behavior, better breastfeeding self-efficacy, more successful breastfeeding initiation, lower EPDS scores, more sleep time, and better appetite than the control group.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, Fudan University, Shanghai, PR China.'}, {'ForeName': 'Qiping', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Obstetrics and Gynecology Hospital of Fudan University, Shanghai, PR China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Obstetrics and Gynecology Hospital of Fudan University, Shanghai, PR China. Electronic address: wangjing1172@sina.com.'}, {'ForeName': 'Jiangbo', 'Initials': 'J', 'LastName': 'Bao', 'Affiliation': 'School of Nursing, Fudan University, Shanghai, PR China. Electronic address: jiangbobao@163.com.'}]",Early human development,['10.1016/j.earlhumdev.2019.104944']
938,24992778,Treatment of polycystic ovarian syndrome with insulin resistance by insulin-sensitizer.,"OBJECTIVE


The aim of this study was to observe clinical curative effects of combination application of dimethylbiguanide and pioglitazone and single application of pioglitazone in patients with polycystic ovarian syndrome (PCOS) complicated with insulin resistance (IR).
MATERIALS AND METHODS


Forty cases of patients with PCOS complicated with IR were investigated, and 20 cases of infertile women without PCOS were taken as the control group. PCOS group was divided into group A and group B according to body mass index (BMI) to detect glucose and lipids metabolism indicators, C reactive protein (CRP), etc. There were 20 cases in group A (Pioglitazone) and 20 cases in group B (dimethylbiguanide and pioglitazone). After treatment for 12 weeks, changes of the above various indicators were compared.
RESULTS


After treatment, insulin resistance index and serum testosterone (T) of two groups patients with PCOS significantly reduced (p < 0.05). Compared to before treatment, BMI of group B significantly reduced (p < 0.05). For INS at two hours after treatment, group B reduced more significantly (p < 0.05).
CONCLUSION


The combination of dimethylbiguanide and pioglitazone was more effective for the treatment of PCOS complicated with IR than simple pioglitazone; chronic inflammation occurrence was possibly one of reasons for insulin sensitivity reduction of patients with PCOS.",2014,"Compared to before treatment, BMI of group B significantly reduced (p < 0.05).","['polycystic ovarian syndrome with insulin resistance by insulin-sensitizer', 'Forty cases of patients with PCOS complicated with IR were investigated, and 20 cases of infertile women without PCOS were taken as the control group', 'patients with polycystic ovarian syndrome (PCOS) complicated with insulin resistance (IR', 'patients with PCOS']","['pioglitazone', 'Pioglitazone', 'PCOS', 'dimethylbiguanide and pioglitazone']",['insulin resistance index and serum testosterone (T'],"[{'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}]",40.0,0.0275072,"Compared to before treatment, BMI of group B significantly reduced (p < 0.05).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Q F', 'Initials': 'QF', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Hu', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
939,25570126,Whole brain EEG synchronization likelihood modulated by long term evolution electromagnetic fields exposure.,"In this paper, we aimed to investigate the possible interactions between human brain and radiofrequency electromagnetic fields (EMF) with electroencephalogram (EEG) technique. Unlike the previous studies which mainly focused on EMF effect on local brain activities, we attempted to evaluate whether the EMF emitted from Long Term Evolution (LTE) devices can modulate the functional connectivity of brain electrical activities. Ten subjects were recruited to participate in a crossover, double-blind exposure experiment which included two sessions (real and sham exposure). In each session, LTE EMF exposure (power on or off) lasted for 30 min and the EEG signals were collected with 32 channels throughout the experiment. Then we applied the synchronization likelihood method to quantify the neural synchronization over the whole brain in different frequency bands and in different EEG record periods. Our results illustrated that the short-term LTE EMF exposure would modulate the synchronization patterns of EEG activation across the whole brain.",2014,Our results illustrated that the short-term LTE EMF exposure would modulate the synchronization patterns of EEG activation across the whole brain.,[],['human brain and radiofrequency electromagnetic fields (EMF) with electroencephalogram (EEG) technique'],['synchronization patterns of EEG activation'],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]",10.0,0.0228707,Our results illustrated that the short-term LTE EMF exposure would modulate the synchronization patterns of EEG activation across the whole brain.,"[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Tongning', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2014.6943758']
940,25570941,Altered cortical causality after remifentanil administration in healthy volunteers: a novel approach for pharmaco-EEG.,"Alterations in cortical causality information flow induced by remifentanil infusion in healthy volunteers was investigated in a placebo-controlled double-blind cross-over study. For each of the 21 enrolled male subjects, 2.5 minutes of resting electroencephalography (EEG) data were collected before and after infusion of remifentanil and placebo. Additionally, to assess cognitive function and analgesic effect, continuous reaction time (CRT) and bone pressure and heat pain were assessed, respectively. The causality information was extracted from the EEG by phase slope index (PSI). Among the features being reproducible between the two baseline recordings, several PSI features were altered by remifentanil administration in comparison to placebo. Furthermore, several of the PSI features altered by remifentanil were correlated to changes in both CRT and pain scores. The results indicate that remifentanil administration influence the information flow between several brain areas. Hence, the EEG causality approach offers the potential to assist in deciphering the cortical effects of remifentanil administration.",2014,"Furthermore, several of the PSI features altered by remifentanil were correlated to changes in both CRT and pain scores.","['21 enrolled male subjects, 2.5 minutes of resting electroencephalography (EEG) data were collected before and after infusion of', 'healthy volunteers']","['placebo', 'remifentanil and placebo', 'remifentanil']","['CRT and pain scores', 'several PSI features', 'cognitive function and analgesic effect, continuous reaction time (CRT) and bone pressure and heat pain']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1706489', 'cui_str': 'Psi'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",21.0,0.103908,"Furthermore, several of the PSI features altered by remifentanil were correlated to changes in both CRT and pain scores.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Khodayari-Rostamabad', 'Affiliation': ''}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Graversen', 'Affiliation': ''}, {'ForeName': 'Soren S', 'Initials': 'SS', 'LastName': 'Olesen', 'Affiliation': ''}, {'ForeName': 'Lasse P', 'Initials': 'LP', 'LastName': 'Malver', 'Affiliation': ''}, {'ForeName': 'Geana P', 'Initials': 'GP', 'LastName': 'Kurita', 'Affiliation': ''}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Sjøgren', 'Affiliation': ''}, {'ForeName': 'Lona L', 'Initials': 'LL', 'LastName': 'Christrup', 'Affiliation': ''}, {'ForeName': 'Asbjørn M', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2014.6944573']
941,25571332,Variability in responsiveness to interventions in people with spinal cord injury: Do some respond better than others?,"Spinal cord injury (SCI) results in significant impairments in function and ankle joint spasticity is a common secondary complication. Various interventions have been trialed to improve function and reduce spasticity after SCI, with variable results. We investigated the effects of a pharmacological (an anti-spastic medication - tizanidine) and a physical intervention (robotic-assisted locomotor training - Lokomat) on function in people with incomplete SCI over 4-week of training. The outcome measures were walking speed, endurance and mobility. Subjects were randomized into one of three groups; no intervention (control), Lokomat (Lok) and tizanidine (Tiz). To account for variability, we used growth mixture modelling (GMM) to class subjects based on their recovery patterns. GMM identified two classes of recovery: high and low function. Significant improvements were seen in walking speed and mobility in high and low functioning subjects in the Lok group, and in walking endurance in high functioning subjects in the Tiz group. However, changes with training were clinically important only for approximately 10% of subjects, who achieved a minimal important difference (MID) in functional outcomes as a result of the training. We used mixed model ANOVAs to compare the group effects. Improvements with training were seen in both classes, however no differences between interventions were found. The GMM had classed all subjects that achieved the MID as high functioning. GMM can be used to successfully class subjects; however larger subject numbers and longer interventions are required to fully utilize this technique. Our results demonstrate that both interventions have potential to improve walking capacity, but more intense training for a longer period may need to achieve MID.",2014,"Significant improvements were seen in walking speed and mobility in high and low functioning subjects in the Lok group, and in walking endurance in high functioning subjects in the Tiz group.","['people with incomplete SCI over 4-week of training', 'people with spinal cord injury']","['physical intervention (robotic-assisted locomotor training - Lokomat', 'pharmacological (an anti-spastic medication - tizanidine', 'GMM', 'no intervention (control), Lokomat (Lok) and tizanidine (Tiz']","['walking speed and mobility', 'walking capacity', 'function and ankle joint spasticity', 'walking speed, endurance and mobility', 'walking endurance']","[{'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training (regime/therapy)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0146011', 'cui_str': 'tizanidine'}, {'cui': 'C0061773', 'cui_str': 'GMM'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0003087', 'cui_str': 'Ankle Syndesmosis'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",,0.0254059,"Significant improvements were seen in walking speed and mobility in high and low functioning subjects in the Lok group, and in walking endurance in high functioning subjects in the Tiz group.","[{'ForeName': 'Lynsey D', 'Initials': 'LD', 'LastName': 'Duffell', 'Affiliation': ''}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': ''}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Mehdi M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2014.6944964']
942,24283158,Idiopathic premature ovarian failure: what is the most suitable ovarian stimulation protocol?,"OBJECTIVE


To evaluate the ovarian response to ovarian stimulation in women with idiopathic premature ovarian failure (POF) in a prospective, controlled, and sequential crossover pilot study.
MATERIALS AND METHODS


Ten women with idiopathic premature ovarian failure and normal karyotype were included in the study. Phase I was comprised of three consecutive control cycles consisting each of estrogen progestin sequential therapy. Phase II was comprised of three consecutive treatment cycles combining the use of gonadotropin-releasing hormone agonist (GnRHa) in the background of estrogen priming, followed by gonadotropin ovarian stimulation and corticosteroid immunosuppression.
RESULTS


Ovulation rates in the treatment cycles (0/10; 0%) did not differ from control cycles (0/10; 0%).
CONCLUSIONS


The findings of this pilot study showed that the combination of estrogen priming, corticosteroid immune-suppression, GnRHa pituitary desensitization, and followed by gonadotropin ovarian stimulation is ineffective in restoring ovarian function in women with idiopathic POF.",2013,"RESULTS


Ovulation rates in the treatment cycles (0/10; 0%) did not differ from control cycles (0/10; 0%).
","['Ten women with idiopathic premature ovarian failure and normal karyotype', 'women with idiopathic premature ovarian failure (POF', 'Idiopathic premature ovarian failure', 'women with idiopathic POF']","['ovarian stimulation', 'gonadotropin-releasing hormone agonist (GnRHa', 'estrogen progestin sequential therapy', 'gonadotropin ovarian stimulation']",['Ovulation rates'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4303510', 'cui_str': 'Idiopathic premature ovarian failure (disorder)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1261273', 'cui_str': 'Karyotype'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}]","[{'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0029965', 'cui_str': 'Ovulation'}]",10.0,0.0582292,"RESULTS


Ovulation rates in the treatment cycles (0/10; 0%) did not differ from control cycles (0/10; 0%).
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Awwad', 'Affiliation': 'Reproductive Endocrinology and Infertility, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Farra', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hannoun', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Abou-Abdallah', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Isaacson', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ghazeeri', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
943,32424486,"Continuous basal infusion versus programmed intermittent bolus for quadratus lumborum block after laparoscopic colorectal surgery: a randomized-controlled, double-blind study.","BACKGROUND


Quadratus lumborum block (QLB) has recently attracted attention as a part of multimodal analgesia after abdominal surgery. It has been shown that programmed intermittent boluses of local anesthetic can produce better analgesia and wider sensory blockade compared with continuous basal infusion with some peripheral nerve blocks. The present study was conducted to see if this theory holds true for QLB in patients undergoing laparoscopic colorectal surgery.
METHODS


Fifty patients undergoing laparoscopic colorectal surgery were divided into 2 groups to receive continuous basal infusion (group C) or programmed intermittent boluses (group PIB) of local anesthetic. After surgery, patients received the posterior approach to QLB and a catheter was introduced bilaterally. Patients in group C received a continuous infusion of 0.15% levobupivacaine at 3 ml/h, and those in group PIB received a bolus of 12 ml every 4 h. All patients received intravenous patient-controlled analgesia using fentanyl. Measurements were taken for cumulative fentanyl consumption, pain scores, cutaneous sensory blockade, analgesic requirements, and adverse events for 46 h.
RESULTS


The primary outcome of cumulative fentanyl consumption at 22 h showed no significant difference between the groups [group C: 11.9 (11.2-15.5) µg/kg (median (interquartile range)) and group PIB: 12.3 (11.6-15.3), p = 0.473]. Pain scores, demands for rescue analgesics, and spread of cutaneous sensory blockade were similar for the two groups.
CONCLUSION


Programmed intermittent boluses of local anesthetic for continuous QLB did not produce better analgesia or wider sensory blockade compared with continuous basal infusion in patients undergoing laparoscopic colorectal surgery.",2020,"Measurements were taken for cumulative fentanyl consumption, pain scores, cutaneous sensory blockade, analgesic requirements, and adverse events for 46 h.
","['Fifty patients undergoing laparoscopic colorectal surgery', 'patients undergoing laparoscopic colorectal surgery', 'quadratus lumborum block after laparoscopic colorectal surgery']","['Quadratus lumborum block (QLB', 'Continuous basal infusion', 'continuous basal infusion (group C) or programmed intermittent boluses (group PIB) of local anesthetic', 'intravenous patient-controlled analgesia using fentanyl', 'continuous infusion of 0.15% levobupivacaine']","['cumulative fentanyl consumption', 'cumulative fentanyl consumption, pain scores, cutaneous sensory blockade, analgesic requirements, and adverse events', 'Pain scores, demands for rescue analgesics, and spread of cutaneous sensory blockade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus'}, {'cui': 'C1568156', 'cui_str': 'Pittsburgh compound B'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}]",50.0,0.158262,"Measurements were taken for cumulative fentanyl consumption, pain scores, cutaneous sensory blockade, analgesic requirements, and adverse events for 46 h.
","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Aoyama', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Sakura', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan. ssakura@med.shimane-u.ac.jp.'}, {'ForeName': 'Aumjit', 'Initials': 'A', 'LastName': 'Wittayapairoj', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Tadenuma', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo City, Shimane, 693-8501, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02791-x']
944,24597251,Effect of short-term tibolone treatment on risk markers for cardiovascular disease in healthy postmenopausal women: a randomized controlled study.,"OBJECTIVE


The aim of this prospective randomized controlled cross sectional study was to evaluate the effect of a six month tibolone treatment in healthy postmenopausal women on biochemical CVD markers by calculating the changes of the blood serum levels of total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides (Tg), high-sensitivity C-reactive protein (hsCRP), homocysteine (Hcy), and endothelin-1 (ET-1) at the beginning of the treatment and after six months.
MATERIALS AND METHODS


Fifty-two healthy postmenopausal women were enrolled in a prospective, randomized, case-controlled outpatient trial. Group 1 (n = 26) received 2,5 mg/d tibolone for six months, while Group 2 (n = 26) received no treatment. Serum levels ofTC, LDL, HDL, Tg, hsCRP, Hcy, and ET-1 were evaluated at baseline and after six months.
RESULTS


The two groups did not statistically differ at baseline characteristics. In Group 1 tibolone treatment decreased significantly TC (p = 0.01), HDL (p < 0.001), and Tg (p < 0.001) serum levels while a significant increase ofhsCRP (p < 0.001) was observed. Finally no changes were noticed on LDL, Hcy, and ET-1 serum levels. Regarding Group 2, no changes were observed.
CONCLUSION


Short-term tibolone treatment in healthy postmenopausal women exerts a mixed action, acting beneficially in some markers (TC, LDL, Tg, Hcy, and ET-1) where as detrimentally in others (HDL, hsCRP).",2013,"In Group 1 tibolone treatment decreased significantly TC (p = 0.01), HDL (p < 0.001), and Tg (p < 0.001) serum levels while a significant increase ofhsCRP (p < 0.001) was observed.","['healthy postmenopausal women', 'Fifty-two healthy postmenopausal women']","['short-term tibolone', 'tibolone', 'Short-term tibolone']","['HDL', 'LDL, Hcy, and ET-1 serum levels', 'blood serum levels of total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides (Tg), high-sensitivity C-reactive protein (hsCRP), homocysteine (Hcy), and endothelin-1 (ET-1', 'biochemical CVD markers', 'Serum levels ofTC, LDL, HDL, Tg, hsCRP, Hcy, and ET-1', 'ofhsCRP', 'TC']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0076660', 'cui_str': 'tibolone'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}]",52.0,0.0312186,"In Group 1 tibolone treatment decreased significantly TC (p = 0.01), HDL (p < 0.001), and Tg (p < 0.001) serum levels while a significant increase ofhsCRP (p < 0.001) was observed.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Traianos', 'Affiliation': 'First Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, ""Papageorghiou"" General Hospital of Thessaloniki, Greece.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vavilis', 'Affiliation': 'First Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, ""Papageorghiou"" General Hospital of Thessaloniki, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Makedos', 'Affiliation': 'First Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, ""Papageorghiou"" General Hospital of Thessaloniki, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karkanaki', 'Affiliation': 'Third Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, ""Ippokrateio"" General Hospital of Thessaloniki, Greece.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ravanos', 'Affiliation': 'Third Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, ""Ippokrateio"" General Hospital of Thessaloniki, Greece.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Prapas', 'Affiliation': 'Third Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, ""Ippokrateio"" General Hospital of Thessaloniki, Greece.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Tarlatzis', 'Affiliation': 'First Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, ""Papageorghiou"" General Hospital of Thessaloniki, Greece.'}]",Clinical and experimental obstetrics & gynecology,[]
945,24597260,Investigation on delivery analgesia effect of combined spinal epidural anesthesia plus Doula and safety of mother and baby.,"OBJECTIVE


To explore the effect of patient-controlled lumbar epidural combined anesthesia with Doula for labor analgesia with ropivacaine and sufentanil, and its influence on the progress of labor, and outcomes of mother and infant.
MATERIALS AND METHODS


Two hundred parturients that requested labor analgesia were randomly selected by patient-controlled lumbar epidural combined anesthesia with Doula as the observation group, meanwhile another 200 parturients were selected as the control group without any analgesic measurements. Labor pain score, labor duration, blood gas analysis results, the incidence of cesarean section, neonatal asphyxia, and postpartum hemorrhage were compared between the two groups.
RESULTS


Compared with the control group, labor analgesic effect was remarkable, the cesarean section rate was significantly reduced in observation group, and the difference was statistically significant (p < 0.05), but with respect to the duration of labor, maternal, postpartum hemorrhage, and neonatal asphyxia, there was no statistical significance between the two groups (p > 0.5). In the observation group regarding maternal and neonatal blood gas analysis results, PO2 was higher and PCO2 was lower than those in the control group. The differences were statistically significant (p < 0.05).
CONCLUSION


Labor analgesia by patient-controlled lumbar epidural combined anesthesia accompanied with Doula with ropivacaine and sufentanil is effective, safe, reliable, has no adverse effects, and reduces cesarean section rate.",2013,"Compared with the control group, labor analgesic effect was remarkable, the cesarean section rate was significantly reduced in observation group, and the difference was statistically significant (p < 0.05), but with respect to the duration of labor, maternal, postpartum hemorrhage, and neonatal asphyxia, there was no statistical significance between the two groups (p > 0.5).","['mother and baby', 'Two hundred parturients that requested labor analgesia were randomly selected by patient-controlled lumbar epidural combined anesthesia with Doula as the observation group, meanwhile another 200 parturients were selected as the']","['ropivacaine', 'ropivacaine and sufentanil', 'control group without any analgesic measurements', 'sufentanil']","['labor analgesic effect', 'duration of labor, maternal, postpartum hemorrhage, and neonatal asphyxia', 'Labor pain score, labor duration, blood gas analysis results, the incidence of cesarean section, neonatal asphyxia, and postpartum hemorrhage', 'cesarean section rate']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C2936640', 'cui_str': 'Doulas'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor (observable entity)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia Neonatorum'}, {'cui': 'C0474368', 'cui_str': 'Labor Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]",,0.0287401,"Compared with the control group, labor analgesic effect was remarkable, the cesarean section rate was significantly reduced in observation group, and the difference was statistically significant (p < 0.05), but with respect to the duration of labor, maternal, postpartum hemorrhage, and neonatal asphyxia, there was no statistical significance between the two groups (p > 0.5).","[{'ForeName': 'Bi-Bo', 'Initials': 'BB', 'LastName': 'Feng', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tongren Hospital of Capital Medical University, Beijing, China. bibofengcn@126.com'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tongren Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Zhai', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing Tongren Hospital of Capital Medical University, Beijing, China.'}]",Clinical and experimental obstetrics & gynecology,[]
946,24283179,A comparison of the effect of levonorgestrel IUD with oral medroxyprogesterone acetate on abnormal uterine bleeding with simple endometrial hyperplasia and fertility preservation.,"OBJECTIVE


Endometrial hyperplasia is clinically important, because it can lead to abnormal uterine bleeding (AUB) which itself can precede endometrial cancer. Endometrial carcinoma is the most common malignancy of the female genital tract, occurring in about 75%-85% younger, perimenopausal women as endometrial hyperplasia. The treatment is hysterectomy or hormone therapy with progesterone. The aim of this study was, therefore, to compare the effect of levonorgestrel intrauterine device (LNG-IUD) with medroxyprogesterone acetate (MPA) on simple endometrial hyperplasia for fertility preservation.
MATERIALS AND METHODS


Forty women in reproductive age (22-47 years) with AUB with endometrial biopsies confirming simple hyperplasia, were enrolled in this study and then randomly divided into two groups. All patients presented with designed special checklist which was filled with satisfaction. Complete history and physical examination especially blood pressure (BP), body mass index (BMI), breast examination, bimanual vaginal examination, and transvaginal sonography (to measure the thickness of endometrial and exclude the other pathologic lesions) were performed. In the first group, treatment was performed with MPA (20 mg/daily) for ten days and in other group with LNG-IUD was prescribed. After three months, transvaginal sonography and biopsy of endometrium were done. The status of AUB and side-effects of two methods,along with the rate of satisfactory were evaluated.
RESULT


The findings showed the significant differences in the treatment of simple hyperplasia between two groups (LNG-IUD group vs. MPA group) (p < 0.047). Recovery of AUB in the group LNG was enhanced (p < 0.047). Endometrial thickness was reduced in both groups (p < 0.001), but further reduction in LNG group was seen. Also, LNG was tolerated more than MPA. Side-effects of MPA were more and reached significance (p < 0.003). The rate of satisfaction with LNG was higher than MPA and reached significance (p < 0.048).
CONCLUSION


The results of this study show that LNG-IUD is more effective than MPA in treatment of simple endometrial hyperplasia and can be helpful in young women who want to preserve their fertilities.",2013,"Endometrial thickness was reduced in both groups (p < 0.001), but further reduction in LNG group was seen.","['Forty women in reproductive age (22-47 years) with AUB with endometrial biopsies confirming simple hyperplasia', 'young women who want to preserve their fertilities', 'abnormal uterine bleeding with simple endometrial hyperplasia and fertility preservation']","['LNG-IUD', 'hysterectomy or hormone therapy with progesterone', 'levonorgestrel IUD with oral medroxyprogesterone acetate', 'levonorgestrel intrauterine device (LNG-IUD', 'MPA', 'medroxyprogesterone acetate (MPA', 'LNG']","['Recovery of AUB', 'Complete history and physical examination especially blood pressure (BP), body mass index (BMI), breast examination, bimanual vaginal examination, and transvaginal sonography (to measure the thickness of endometrial and exclude the other pathologic lesions', 'rate of satisfaction with LNG', 'transvaginal sonography and biopsy of endometrium', 'simple hyperplasia', 'Endometrial thickness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510477', 'cui_str': 'Endometrial biopsy (procedure)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding (disorder)'}, {'cui': 'C0456483', 'cui_str': 'Simple Endometrial Hyperplasia'}, {'cui': 'C1171194', 'cui_str': 'Fertility Preservation'}]","[{'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}]","[{'cui': 'C0199189', 'cui_str': 'History and physical examination, complete (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0199850', 'cui_str': 'Examination of breast (procedure)'}, {'cui': 'C0200048', 'cui_str': 'Vaginal Exam'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}]",40.0,0.0597918,"Endometrial thickness was reduced in both groups (p < 0.001), but further reduction in LNG group was seen.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Karimi-Zarchi', 'Affiliation': 'Gynecology Oncology Department, Shahid Sadoughi University of Medical Science, Yazd, Iran.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dehghani-Firoozabadi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tabatabaie', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Dehghani-Firoozabadi', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Teimoori', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chiti', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Miratashi-Yazdi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dehghani', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
947,31805855,A randomized controlled trial on analgesic effect of repeated Quadratus Lumborum block versus continuous epidural analgesia following laparoscopic nephrectomy.,"BACKGROUND


Epidural analgesia as the effective pain management for abdominal surgery has side effects such as paresthesia, hypotension, hematomas, and impaired motoric of lower limbs. The quadratus lumborum block (QLB) has potential as an abdominal truncal block, however, its analgesic efficacy has never been compared to epidural analgesia on laparoscopic nephrectomy. This prospective randomized controlled study compared the effectiveness of QLB with the epidural analgesia technique in relieving postoperative pain following transperitoneal laparoscopic nephrectomy.
METHODS


Sixty-two patients underwent laparoscopic donor nephrectomy and were randomized to receive QLB (n = 31) or continuous epidural (n = 31). The QLB group received bilateral QLB using 0.25% bupivacaine and the epidural group received 6 ml/h of 0.25% bupivacaine for intraoperative analgesia. As postoperative analgesia, the QLB group received repeated bilateral QLB with the same dose and the epidural group received 6 ml/h of 0.125% bupivacaine for 24 h after surgery completion. The primary outcome was the 24-h cumulative morphine requirement after surgery. The secondary outcome was the postoperative pain scores. Sensory block coverage, hemodynamic changes, Bromage score, postoperative nausea-vomiting (PONV), paresthesia, and duration of urinary catheter usage were recorded and analyzed.
RESULT


The 24-h cumulative morphine requirement and pain scores after surgery were comparable between the QLB and epidural groups. The coverage of QLB was extended from T9 to L2 and the continuous epidural block was extended from T8 to L3 dermatomes. The mean arterial pressure (MAP) measured at 24 h after surgery was lower in the epidural group (p = 0.001). Bromage score, incidence of PONV, and paresthesia were not significantly different between the two groups. Duration of urinary catheter usage was shorter (p < 0.001) in the QLB group.
CONCLUSION


The repeated QLB had a similar 24-h cumulative morphine requirement, comparable postoperative pain scores and sensory blockade, higher postoperative MAP, a similar degree of motoric block, no difference in the incidence of PONV and paresthesia, and shorter urinary catheter usage, compared to the continuous epidural analgesia following transperitoneal laparoscopic nephrectomy.
TRIAL REGISTRATION


ClinicalTrial.gov NCT03520205 retrospectively registered on May 9th 2018.",2019,"The repeated QLB had a similar 24-h cumulative morphine requirement, comparable postoperative pain scores and sensory blockade, higher postoperative MAP, a similar degree of motoric block, no difference in the incidence of PONV and paresthesia, and shorter urinary catheter usage, compared to the continuous epidural analgesia following transperitoneal laparoscopic nephrectomy.
",['Sixty-two patients underwent'],"['laparoscopic donor nephrectomy', 'transperitoneal laparoscopic nephrectomy', 'continuous epidural', 'bilateral QLB', 'repeated Quadratus Lumborum block versus continuous epidural analgesia', 'QLB', 'laparoscopic nephrectomy', 'bupivacaine', 'epidural group received 6\u2009ml/h of 0.125% bupivacaine', 'epidural analgesia technique']","['postoperative pain scores and sensory blockade, higher postoperative MAP', '24-h cumulative morphine requirement and pain scores', 'postoperative pain', '24-h cumulative morphine requirement', 'Bromage score, incidence of PONV, and paresthesia', 'mean arterial pressure (MAP', 'incidence of PONV and paresthesia, and shorter urinary catheter usage', 'Duration of urinary catheter usage', 'Sensory block coverage, hemodynamic changes, Bromage score, postoperative nausea-vomiting (PONV), paresthesia, and duration of urinary catheter usage', 'coverage of QLB', 'postoperative pain scores']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0411257', 'cui_str': 'Donor nephrectomy (procedure)'}, {'cui': 'C0205501', 'cui_str': 'Transperitoneal approach (qualifier value)'}, {'cui': 'C0027695', 'cui_str': 'Nephrectomy'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439391', 'cui_str': 'mL/h'}, {'cui': 'C4517427', 'cui_str': '0.125 (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",62.0,0.179391,"The repeated QLB had a similar 24-h cumulative morphine requirement, comparable postoperative pain scores and sensory blockade, higher postoperative MAP, a similar degree of motoric block, no difference in the incidence of PONV and paresthesia, and shorter urinary catheter usage, compared to the continuous epidural analgesia following transperitoneal laparoscopic nephrectomy.
","[{'ForeName': 'Dita', 'Initials': 'D', 'LastName': 'Aditianingsih', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Cipto Mangunkusumo General Hospital, Universitas Indonesia, 6th Salemba Raya, DKI Jakarta, 10430, Indonesia. ditaaditiaa@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Pryambodho', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Cipto Mangunkusumo General Hospital, Universitas Indonesia, 6th Salemba Raya, DKI Jakarta, 10430, Indonesia.'}, {'ForeName': 'Naufal', 'Initials': 'N', 'LastName': 'Anasy', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Cipto Mangunkusumo General Hospital, Universitas Indonesia, 6th Salemba Raya, DKI Jakarta, 10430, Indonesia.'}, {'ForeName': 'Aida Rosita', 'Initials': 'AR', 'LastName': 'Tantri', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Cipto Mangunkusumo General Hospital, Universitas Indonesia, 6th Salemba Raya, DKI Jakarta, 10430, Indonesia.'}, {'ForeName': 'Chaidir Arif', 'Initials': 'CA', 'LastName': 'Mochtar', 'Affiliation': 'Department of Urology, Cipto Mangunkusumo General Hospital, Universitas Indonesia, DKI Jakarta, Indonesia.'}]",BMC anesthesiology,['10.1186/s12871-019-0891-7']
948,24111257,Mental fatigue and working memory load estimation: interaction and implications for EEG-based passive BCI.,"Current mental state monitoring systems, a.k.a. passive brain-computer interfaces (pBCI), allow one to perform a real-time assessment of an operator's cognitive state. In EEG-based systems, typical measurements for workload level assessment are band power estimates in several frequency bands. Mental fatigue, arising from growing time-on-task (TOT), can significantly affect the distribution of these band power features. However, the impact of mental fatigue on workload (WKL) assessment has not yet been evaluated. With this paper we intend to help fill in this lack of knowledge by analyzing the influence of WKL and TOT on EEG band power features, as well as their interaction and its impact on classification performance. Twenty participants underwent an experiment that modulated both their WKL (low/high) and time spent on the task (short/long). Statistical analyses were performed on the EEG signals, behavioral and subjective data. They revealed opposite changes in alpha power distribution between WKL and TOT conditions, as well as a decrease in WKL level discriminability with increasing TOT in both number of statistical differences in band power and classification performance. Implications for pBCI systems and experimental protocol design are discussed.",2013,"Mental fatigue, arising from growing time-on-task (TOT), can significantly affect the distribution of these band power features.",['Twenty participants underwent an experiment that modulated both their WKL (low/high) and time spent on the task (short/long'],[],"['Mental fatigue, arising from growing time-on-task (TOT', 'WKL level discriminability']","[{'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",[],"[{'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",20.0,0.0146078,"Mental fatigue, arising from growing time-on-task (TOT), can significantly affect the distribution of these band power features.","[{'ForeName': 'Raphaelle N', 'Initials': 'RN', 'LastName': 'Roy', 'Affiliation': ''}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Bonnet', 'Affiliation': ''}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Charbonnier', 'Affiliation': ''}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Campagne', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2013.6611070']
949,24111281,Motor recovery monitoring in post acute stroke patients using wireless accelerometer and cross-correlation.,"Stroke is a major reason for physical immobility and death. For effective treatment of stroke, early diagnosis and aggressive medication in the form of thrombolytic drugs is shown to be essential. In order to provide proper care, the patient should be kept under continuous monitoring during the first few hours after subjecting thrombolytic drugs and based on the response of the patient to the medication, line of treatment should be changed. In our previous work [1], we have shown the proof of principle by monitoring the motor activity of the stroke patient using accelerometer fitted on patient's arms. Based on preliminary analysis, we proposed methods using resultant acceleration signal and showed its effectiveness in predicting National Institute of Health Stroke Scale (NIHSS) stroke index. In this paper, novel technique based on cross-correlation of accelerometer values along different axes is developed for predicting the NIHSS index. An overall increase in prediction accuracy by over 7% compared to the earlier method is obtained. A multi-class support vector machine (SVM) classifier for cross correlation features is also designed and an overall prediction accuracy of 93% is achieved.",2013,An overall increase in prediction accuracy by over 7% compared to the earlier method is obtained.,['post acute stroke patients'],['multi-class support vector machine (SVM) classifier'],"['prediction accuracy', 'National Institute of Health Stroke Scale (NIHSS) stroke index']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}]","[{'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}, {'cui': 'C0456712', 'cui_str': 'Stroke index (observable entity)'}]",,0.0225968,An overall increase in prediction accuracy by over 7% compared to the earlier method is obtained.,"[{'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Jayavardhana', 'Initials': 'J', 'LastName': 'Gubbi', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Marimuthu', 'Initials': 'M', 'LastName': 'Palaniswami', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2013.6611094']
950,23444748,"Comparison of electrolytic status (Na+, K+, Ca2+, Mg2+) in preterm and term deliveries.","PURPOSE OF INVESTIGATION


The objective of this study was to evaluate the electrolytic status of Na+, K+, Ca+, and Mg2+ in serum and red blood cells in idiopathic preterm and term deliveries.
METHODS


The study included 105 pregnant women diagnosed with idiopathic premature delivery (study group) and 36 pregnant women with physiologically term delivery (controls). Samples of mother's blood were collected and analyzed for the level of electrolytes in the serum/plasma and red blood cells.
RESULTS


Measured values of magnesium in red blood cells in the study group were far lower than physiological values, intracellular calcium levels were higher in the study group compared to levels measured in the controls. Sodium concentrations in cells were significantly lower in subjects with premature delivery.
CONCLUSION


The magnesium intracellular level is the best representative value of magnesium in the body.",2012,"Sodium concentrations in cells were significantly lower in subjects with premature delivery.
","['preterm and term deliveries', 'idiopathic preterm and term deliveries', '105 pregnant women diagnosed with idiopathic premature delivery (study group) and 36 pregnant women with physiologically term delivery (controls', 'subjects with premature delivery']","['electrolytic status (Na+, K+, Ca2+, Mg2']","['electrolytic status of Na+, K+, Ca+, and Mg2+ in serum and red blood cells', 'red blood cells', 'intracellular calcium levels', 'Sodium concentrations in cells']","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0337443', 'cui_str': 'Sodium measurement (procedure)'}, {'cui': 'C2603574', 'cui_str': 'Ca(BD4)2'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0337443', 'cui_str': 'Sodium measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement (procedure)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]",105.0,0.0556889,"Sodium concentrations in cells were significantly lower in subjects with premature delivery.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mitrovic-Jovanovic', 'Affiliation': 'University Clinic of Gynecology and Obstetrics Narodni Front, School of Medicine, Belgrade, Serbia. anamitrovicjov@gmail.com'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dragojevic-Dikic', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zamurovic', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Nikolic', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gojnic', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rakic', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
951,23444750,Oral supplementation with antioxidant agents containing alpha lipoic acid: effects on postmenopausal bone mass.,"PURPOSE OF INVESTIGATION


Oxidative stress impacts many age-related degenerative processes, such as in postmenopausal bone loss and in antioxidant defenses that are significantly decreased in elderly osteoporotic women. The authors evaluated the effect of oral supplementation with antioxidant agents containing alpha lipoic acid (ALA) on bone mineral density (BMD) of osteopenic postmenopausal women.
MATERIALS AND METHODS


Fifty postmenopausal women with osteopenia (-2.5 < T-score < -1) were prospectively enrolled and randomly assigned to orally receive ALA and other antioxidant agents (vitamin C, vitamin E, and selenium) plus calcium and vitamin D3 (n = 25), or only calcium and vitamin D3 (n = 25). The BMD was estimated at baseline and after 12 months of treatment by heel quantitative ultrasonometry (QUS).
RESULTS


Forty-four patients completed the one-year study: 23 in the ALA group, 21 in the control group. The treatment of ALA group led to a better estimated BMD compared to the control group (0.401 +/- 0.026 vs 0.388 +/- 0.025 g/cm2), although this difference barely achieved a statistical significance (p = 0.048).
CONCLUSION


These findings, although in a small population, could suggest that oral supplementation with antioxidant agents containing ALA may mitigate bone loss in osteopenic postmenopausal women.",2012,The treatment of ALA group led to a better estimated BMD compared to the control group (0.401 +/-,"['postmenopausal bone mass', 'osteopenic postmenopausal women', 'Fifty postmenopausal women with osteopenia ', 'Forty-four patients completed the one-year study: 23 in the ALA group, 21 in the control group', 'elderly osteoporotic women']","['Oral supplementation with antioxidant agents containing alpha lipoic acid', 'ALA and other antioxidant agents (vitamin C, vitamin E, and selenium) plus calcium and vitamin D3 (n = 25), or only calcium and vitamin D3', 'antioxidant agents containing ALA', 'oral supplementation with antioxidant agents containing alpha lipoic acid (ALA', 'ALA']","['bone mineral density (BMD', 'BMD']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0023791', 'cui_str': 'alpha-lipoic acid'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",50.0,0.118672,The treatment of ALA group led to a better estimated BMD compared to the control group (0.401 +/-,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mainini', 'Affiliation': 'San Leonardo Hospital, Castellammare di Stabia, Naples, Italy. giampaolomainini@libero.it'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rotondi', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Di Nola', 'Affiliation': ''}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Pezzella', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Iervolino', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Seguino', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': ""D'Eufemia"", 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Iannicelli', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Torella', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
952,23444759,Does vaginal pH affect the efficacy of dinoprostone in cervical ripening/labor duration?,"BACKGROUND


Prostaglandins are effective in the ripening of the cervix and facilitating labor induction. Vaginal pH is probably an important factor in the effectiveness of vaginal prostaglandins. The aim of this study was to evaluate the effect of vaginal pH on the function of prostaglandin vaginal tablet during labor.
METHODS


This is a double-blinded clinical trial study of 147 pregnant primigravid trated in the Yahyanejad Hospital of Babol (Iran) from January 2006 to December 2007. Initial pH was measured during vaginal examination with nitrazin paper and the Bishop score was determined. All women received vaginal dinoprostone inserted in the posterior fornix of the vagina for cervical ripening and the second dose was administered if the uterine contractions were inadequate. Reassessment of the Bishop score after 12 hours, duration of latent and active phases, and also the duration of the second stage of labor were compared between the two groups with low or high vaginal pH.
RESULTS


The incidence of Cesarean section was lower in women with high vaginal pH but was not statistically significant. The Bishop score after 12 hours, latent phase, and second stage durations were not different in the two groups of high or low vaginal pH, but active phase duration in patients with high pH was significantly shorter than those with low pH (p = 0.019).
CONCLUSION


High vaginal pH influences the function of prostaglandin tablet as a reduction in duration of the active phase of labor.",2012,"The Bishop score after 12 hours, latent phase, and second stage durations were not different in the two groups of high or low vaginal pH, but active phase duration in patients with high pH was significantly shorter than those with low pH (p = 0.019).
",['147 pregnant primigravid trated in the Yahyanejad Hospital of Babol (Iran) from January 2006 to December 2007'],"['vaginal pH', 'vaginal dinoprostone', 'dinoprostone']","['duration of latent and active phases', 'duration of the second stage of labor', 'Initial pH', 'incidence of Cesarean section']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0429263', 'cui_str': 'Vaginal pH (observable entity)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]",147.0,0.0847202,"The Bishop score after 12 hours, latent phase, and second stage durations were not different in the two groups of high or low vaginal pH, but active phase duration in patients with high pH was significantly shorter than those with low pH (p = 0.019).
","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Basirat', 'Affiliation': 'Fatemezahra Infertility and Reproductive Health Research Center, Babol University of Medical Science, Babol, Iran.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Barat', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ghanbarpour', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Golsorkhtabar-Amiri', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
953,23444761,Effects of vaginal versus oral misoprostol to terminate second-trimester pregnancy.,"OBJECTIVES


Using surgical methods compared to medical methods, such as misoprostol for termination of pregnancy, has several side effects. This study was performed in order to compare the effect of vaginal and oral misoprostol in second-trimester pregnancy termination (14-24 weeks).
MATERIALS AND METHODS


The authors performed a clinical trial study in 40 pregnant women at 14 to 24 weeks of gestation and candidates for medical interruption of pregnancy. All patients received 600 microg of vaginal misoprostol as primary dosage and then, were placed randomly in two groups consisting of 20 patients that received 400 microg of vaginal or oral misoprostol, every four hours, up to three doses. If the abortion was incomplete, oxytocin was used. Twenty-four hours after the procedure, uterine sonography was performed in all patients and if residue was found, the patients were then candidates for curettage.
RESULTS


Seventeen patients (85%) in the vaginal group and 17 patients (85%) in the oral group had successful pregnancy interruption. The mean interval until the discharge of pregnancy products in the vaginal group (15/42 +/- 10/84) showed no significant difference compared to the oral group (12/65 +/- 7/8) and no significant differences in side-effects were found between the two groups.
CONCLUSION


Oral misoprostol is as effective as vaginal misoprostol in performing second-trimester abortion. It appears that the vaginal misoprostol primary dose together with the continuation of oral dose is not more effective compared to the vaginal misoprostol method alone.",2012,"RESULTS


Seventeen patients (85%) in the vaginal group and 17 patients (85%) in the oral group had successful pregnancy interruption.",['40 pregnant women at 14 to 24 weeks of gestation and candidates for medical interruption of pregnancy'],"['oxytocin', 'vaginal versus oral misoprostol', 'vaginal misoprostol', 'vaginal and oral misoprostol', 'misoprostol', '400 microg of vaginal or oral misoprostol']","['successful pregnancy interruption', 'side-effects', 'uterine sonography', 'mean interval until the discharge of pregnancy products']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",40.0,0.141117,"RESULTS


Seventeen patients (85%) in the vaginal group and 17 patients (85%) in the oral group had successful pregnancy interruption.","[{'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Yazdani', 'Affiliation': 'Fatemezahra Infertility and Reproductive Health Research Center, Babol University of Medical Science, Babol, Northern Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zeinalzadeh', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Bouzari', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Golsorkhtabar-Amiri', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
954,23724525,The efficacy of intrauterine versus oral progestin for the treatment of endometrial hyperplasia. A prospective randomized comparative study.,"OBJECTIVES


This study compared the efficacy of the levonorgestrel-releasing intrauterine device (LNG-IUD) to oral medroxyprogesterone acetate (MPA) applied for the same length of time for the management of endometrial hyperplasia without atypia.
STUDY DESIGN


This was single-center, open, randomized, and clinical trial. One hundred four patients aged between 30-50 years and diagnosed with endometrial hyperplasia without atypia by endometrial biopsy, were randomized to receive LNG-IUD or MPA. Both groups were further divided into two groups as three-month and six-month treatment subgroups. The primary objective was to compare the complete regression rates of hyperplasia, and the secondary objective was to determine the minimum duration of time required for the achievement of regression.
RESULTS


At two-year follow-up, the success rates of LNG-IUD treatment and oral MPA for three months therapy were 84% and 50%, respectively. While the regression rate was 100% in the six-month LNG-IUD group, it was 64% in the oral MPA group. LNG-IUD appeared to have a significantly higher success rate (p = 0.0001).
CONCLUSION


It is believed that by this study LNG-IUD applications may be a reliable preference for younger patients who wish to preserve their uterus and especially for non-atypical cases, and if the patient demands fertility, even a six-month application will provide effective treatment.",2013,"LNG-IUD appeared to have a significantly higher success rate (p = 0.0001).
","['endometrial hyperplasia without atypia', 'endometrial hyperplasia', 'younger patients who wish to preserve their uterus and especially for non-atypical cases', 'One hundred four patients aged between 30-50 years and diagnosed with endometrial hyperplasia without atypia by endometrial biopsy']","['medroxyprogesterone acetate (MPA', 'intrauterine versus oral progestin', 'levonorgestrel-releasing intrauterine device (LNG-IUD', 'LNG-IUD or MPA']","['regression rate', 'success rates of LNG-IUD treatment and oral MPA', 'success rate', 'minimum duration of time required for the achievement of regression']","[{'cui': 'C2712711', 'cui_str': 'Typical endometrial hyperplasia'}, {'cui': 'C0014173', 'cui_str': 'Endometrial Hyperplasia'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510477', 'cui_str': 'Endometrial biopsy (procedure)'}]","[{'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}]","[{'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",104.0,0.113366,"LNG-IUD appeared to have a significantly higher success rate (p = 0.0001).
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dolapcioglu', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Mustafa Kemal University, Hatay, Turkey. kdolapci@gmail.com'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Boz', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baloglu', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
955,23724526,Ondansetrone or metoclopromide? Which is more effective in severe nausea and vomiting of pregnancy? A randomized trial double-blind study.,"BACKGROUND


Nausea and vomiting of pregnancy (NVP) are seen in 50-80% of pregnancies. However, in severe NVP, called hypermesis gravidarum (HG), medical therapy to reduce nausea and vomiting is inevitable and ondansetron (OND) as an effective drug has recently been proposed. This study evaluated the effectiveness of OND versus metoclopramide (MET) in the treatment of HG.
METHODS


In this clinical trial study, 83 pregnant women with HG were enrolled in 2011-2012 and randomly divided in two groups. The first group received oral administration of MET and the second group was treated with OND for two weeks. Severity of nausea and vomiting were evaluated according to visual analogue scale (VAS) criteria. Data analysis was done by chi2, Fisher exact test and Student's t-test.
RESULTS


Comparison of the trend of change of vomiting in the two groups during the 14-day treatment showed the OND group had significantly lower vomiting scores versus the MET group (p = 0.042), while there was no significant difference in the trend of nausea.
CONCLUSION


OND has a more favorable effect in controlling severe vomiting.",2013,"RESULTS


Comparison of the trend of change of vomiting in the two groups during the 14-day treatment showed the OND group had significantly lower vomiting scores versus the MET group (p = 0.042), while there was no significant difference in the trend of nausea.
",['83 pregnant women with HG were enrolled in 2011-2012 and randomly divided in two groups'],"['OND versus metoclopramide (MET', 'Ondansetrone or metoclopromide']","['Severity of nausea and vomiting', 'nausea and vomiting', 'change of vomiting', 'vomiting scores', 'nausea', 'Nausea and vomiting of pregnancy (NVP', 'visual analogue scale (VAS) criteria']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",83.0,0.0954018,"RESULTS


Comparison of the trend of change of vomiting in the two groups during the 14-day treatment showed the OND group had significantly lower vomiting scores versus the MET group (p = 0.042), while there was no significant difference in the trend of nausea.
","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Kashifard', 'Affiliation': 'Department of Internal Medicine, Babol University of Medical Science, Babol, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Basirat', 'Affiliation': ''}, {'ForeName': 'Maede', 'Initials': 'M', 'LastName': 'Kashifard', 'Affiliation': ''}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Golsorkhtabar-Amiri', 'Affiliation': ''}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Moghaddamnia', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
956,23724529,Ankaferd blood stopper in episiotomy repair.,"BACKGROUND AND OBJECTIVE


Ankaferd blood stopper (ABS) is a new hemostatic agent that is licensed for external hemorrhages. ABS comprises of a standard mixture of Thymus vulgaris, Glycyrrhiza glabra, Vitis vinifera, Alpinia officinarum, and Urtica dioica which has also been approved in Turkey for the management of bleeding. The authors, aim was to evaluate the efficacy of ABS spray in terms of blood loss during episiotomy repair.
MATERIALS AND METHODS


The authors included pregnant women with a term singleton fetus (37-40 wks) in a vertex position, who were at least 18-years-old, had delivered vaginally, and required a mediolateral episiotomy. The patients were randomly assigned to one of the two approaches: 20 (Group 1) to ABS and 20 (Group 2) to isotonic saline solution (0.9% NaCl). The authors applied 4 ml ABS spray solution (1 ml/puff X 4) or isotonic saline solution (0.9% NaCl) (4 ml) topically on a sponge applied on the episiotomy. The sponge was weighed before and after the episiotomy repair to determine the amount of bleeding. Hemoglobin values were also recorded on admission and 12 hours after delivery.
RESULTS


Both groups were similar in terms of maternal age, parity, body mass index and gestational age. The sponges weighed heavier in Group 2. Baseline hemoglobin values measured on admission showed no significant differences between the groups. Hemoglobin on the first postpartum day was significantly higher in the ABS group (p < 0.05). The operative time for episiotomy repair for the two groups was also statistically insignificant. No major immediate or delayed complications were observed in either group.
CONCLUSION


In this study group, the application of 4 ml of ABS instead of isotonic saline solution lessened bleeding.",2013,"No major immediate or delayed complications were observed in either group.
","['pregnant women with a term singleton fetus (37-40 wks) in a vertex position, who were at least 18-years-old, had delivered vaginally, and required a mediolateral episiotomy', 'episiotomy repair']","['isotonic saline solution', 'ABS spray', 'isotonic saline solution (0.9% NaCl']","['Baseline hemoglobin values', 'blood loss', 'operative time for episiotomy repair', 'bleeding', 'Hemoglobin', 'delayed complications', 'Hemoglobin values']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C4521772', 'cui_str': 'Spray'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.0530634,"No major immediate or delayed complications were observed in either group.
","[{'ForeName': 'E G Yapar', 'Initials': 'EG', 'LastName': 'Eyi', 'Affiliation': ""Zekai Tahir Burak Women's Health Research and Education Hospital, Ankara, Turkey. elifgulyapar@yahoo.com""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Engin-Ustün', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kaba', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mollamahmutoğlu', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
957,24111288,Biosignal-based relaxation evaluation of head-care robot.,"Such popular head care procedures as shampooing and scalp massages provide physical and mental relaxation. However, they place a big burden such as chapped hands on beauticians and other practitioners. Based on our robot hand technology, we have been developing a head care robot. In this paper, we quantitatively evaluated its relaxation effect using the following biosignals: accelerated plethymography (SDNN, HF/TP, LF/HF), heart rate (HR), blood pressure, salivary amylase (sAA) and peripheral skin temperature (PST). We compared the relaxation of our developed head care robot with the head care provided by nurses. In our experimental result with 54 subjects, the activity of the autonomic nerve system changed before and after head care procedures performed by both a human nurse and our proposed robot. Especially, in the proposed robot, we confirmed significant differences with the procedure performed by our proposed head care robot in five indexes: HF/TP, LF/HF, HR, sAA, and PST. The activity of the sympathetic nerve system decreased, because the values of its indexes significantly decreased: LF/HF, HR, and sAA. On the other hand, the activity of the parasympathetic nerve system increased, because of the increase of its indexes value: HF/TP and PST. Our developed head care robot provided satisfactory relaxation in just five minutes of use.",2013,"The activity of the sympathetic nerve system decreased, because the values of its indexes significantly decreased: LF/HF, HR, and sAA.",[],[],"['activity of the sympathetic nerve system', 'plethymography (SDNN, HF/TP, LF/HF), heart rate (HR), blood pressure, salivary amylase (sAA) and peripheral skin temperature (PST']",[],[],"[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0443452', 'cui_str': 'Salivary amylase (substance)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}]",54.0,0.0138372,"The activity of the sympathetic nerve system decreased, because the values of its indexes significantly decreased: LF/HF, HR, and sAA.","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ando', 'Affiliation': ''}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Takeda', 'Affiliation': ''}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Maruyama', 'Affiliation': ''}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Susuki', 'Affiliation': ''}, {'ForeName': 'Toshinori', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': ''}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Fujioka', 'Affiliation': ''}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Mizuno', 'Affiliation': ''}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': ''}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Ohno', 'Affiliation': ''}, {'ForeName': 'Honda', 'Initials': 'H', 'LastName': 'Yukio', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2013.6611101']
958,24111291,Subsequence dynamic time warping as a method for robust step segmentation using gyroscope signals of daily life activities.,"The segmentation of gait signals into single steps is an important basis for objective gait analysis. Only a precise detection of step beginning and end enables the computation of step parameters like step height, variability and duration. A special challenge for the application is the accurateness of such an algorithm when based on signals from daily live activities. In this study, gyroscopes were attached laterally to sport shoes to collect gait data. For the automated step segmentation, subsequence Dynamic Time Warping was used. 35 healthy controls and ten patients with Parkinson's disease performed a four times ten meter walk. Furthermore 4 subjects were recorded during different daily life activities. The algorithm enabled counting steps, detecting precisely step beginning and end and rejecting other movements. Results showed a recognition rate of steps during ten meter walk exercises of 97.7% and in daily life activities of 86.7%. The segmentation procedure can be used for gait analysis from daily life activities and can constitute the basis for computation of precise step parameters. The algorithm is applicable for long-term gait monitoring as well as for analyzing gait abnormalities.",2013,Results showed a recognition rate of steps during ten meter walk exercises of 97.7% and in daily life activities of 86.7%.,"[""35 healthy controls and ten patients with Parkinson's disease""]",[],['recognition rate of steps'],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]",[],"[{'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",35.0,0.0263167,Results showed a recognition rate of steps during ten meter walk exercises of 97.7% and in daily life activities of 86.7%.,"[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Barth', 'Affiliation': ''}, {'ForeName': 'Cacilia', 'Initials': 'C', 'LastName': 'Oberndorfer', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kugler', 'Affiliation': ''}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Schuldhaus', 'Affiliation': ''}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Winkler', 'Affiliation': ''}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Klucken', 'Affiliation': ''}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Eskofier', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2013.6611104']
959,24111258,Probing ECG-based mental state monitoring on short time segments.,"Electrocardiography is used to provide features for mental state monitoring systems. There is a need for quick mental state assessment in some applications such as attentive user interfaces. We analyzed how heart rate and heart rate variability features are influenced by working memory load (WKL) and time-on-task (TOT) on very short time segments (5s) with both statistical significance and classification performance results. It is shown that classification of such mental states can be performed on very short time segments and that heart rate is more predictive of TOT level than heart rate variability. However, both features are efficient for WKL level classification. What's more, interesting interaction effects are uncovered: TOT influences WKL level classification either favorably when based on HR, or adversely when based on HRV. Implications for mental state monitoring are discussed.",2013,"What's more, interesting interaction effects are uncovered: TOT influences WKL level classification either favorably when based on HR, or adversely when based on HRV.",[],"['Probing ECG-based mental state monitoring', 'Electrocardiography']","['working memory load (WKL) and time-on-task (TOT', 'heart rate and heart rate variability features']",[],"[{'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0170691,"What's more, interesting interaction effects are uncovered: TOT influences WKL level classification either favorably when based on HR, or adversely when based on HRV.","[{'ForeName': 'Raphaelle N', 'Initials': 'RN', 'LastName': 'Roy', 'Affiliation': ''}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Charbonnier', 'Affiliation': ''}, {'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Campagne', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2013.6611071']
960,23724494,Isolating sperm by selecting those with normal nuclear morphology prior to intracytoplasmic sperm injection (ICSI) does not provide better pregnancy rates compared to conventional ICSI in women with repeated conception failure with in vitro fertilization.,"PURPOSE


To determine if isolation of sperm by nuclear characteristics using high magnification offers any advantage over the normal morphologic methods when performing intracytoplasmic sperm injection (ICSI) in refractory cases in which the male partner had an abnormal DNA fragmentation index.
MATERIALS AND METHODS


Women aged < or = 39 with failure to have a successful conception after three consecutive embryo transfers whose male partner had a DNA fragmentation index > 30% were randomly assigned to isolation of sperm for ICSI by a new high magnification procedure to evaluate nuclear morphology and the usual method with normal magnification where nuclear characteristics were not seen. Women 40-43 were not randomized and were given the option after hearing pros and cons.
RESULTS


Overall the live delivered pregnancy rates were similar in the high vs normal magnification groups (33.3% vs 36.3%).
CONCLUSIONS


Isolation of sperm with normal nuclei with high magnification does not offer any advantage over conventional IVF for refractory cases where the male partner has a high DNA fragmentation index.",2013,"Overall the live delivered pregnancy rates were similar in the high vs normal magnification groups (33.3% vs 36.3%).
","['women with repeated conception failure with in vitro fertilization', 'Women aged < or = 39 with failure to have a successful conception after three consecutive embryo transfers whose male partner had a DNA fragmentation index > 30', 'Women 40-43']","['conventional ICSI', 'intracytoplasmic sperm injection (ICSI']","['pregnancy rates', 'Overall the live delivered pregnancy rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0000702', 'cui_str': 'DNA, A-Form'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.328627,"Overall the live delivered pregnancy rates were similar in the high vs normal magnification groups (33.3% vs 36.3%).
","[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Check', 'Affiliation': 'The University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School at Camden Cooper Hospital/University Medical Center, Department of Obstetrics and Gynecology Division of Reproductive Endocrinology & Infertility, Camden, NJ, USA. laurie@ccivf.com'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bollendorf', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Summers-Chase', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Horwath', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
961,23724512,Comparison of transvaginal 3D sonohysterography with outpatient hysteroscopy in the evaluation of abnormal uterine bleeding.,"OBJECTIVE


To compare transvaginal three-dimensional sonohysterography (3D SHSG) and outpatient hysteroscopy with regards to diagnostic accuracy, procedure time, and patient discomfort with a prospective randomized controlled cohort study in a teaching hospital in London. The study included a population group of 49 women with abnormal uterine bleeding from varied ethnic backgrounds, of which 44 completed the study. Subjects with pregnancies, pelvic infections, large uteruses, suspicious or diagnosed pelvic malignancies, and who did not meet the criteria for day surgery, were excluded.
MATERIALS AND METHODS


Patients were randomized into two groups: group 1 had hysteroscopy followed by SHSG while group 2 had SHSG followed by hysteroscopy. Diagnostic accuracy, procedure time, and patient discomfort of SHSG in comparison to hysteroscopy were studied.
RESULTS


A total of 44 patients completed the study. The average age of the study population was 44.8 years and the mean parity was 1.8. Nulliparas represented 34.03% of the study population and the average duration of symptoms was 14.8 months.
CONCLUSION


In the investigation of women with abnormal bleeding in an outpatient setting, both hysteroscopy and SHSG are comparable in the diagnosis of intracavity lesions, pain rating, and procedure time. However patient acceptability of SHSG was significantly more when compared to outpatient hysteroscopy.",2013,However patient acceptability of SHSG was significantly more when compared to outpatient hysteroscopy.,"['49 women with abnormal uterine bleeding from varied ethnic backgrounds, of which 44 completed the study', 'teaching hospital in London', 'Subjects with pregnancies, pelvic infections, large uteruses, suspicious or diagnosed pelvic malignancies, and who did not meet the criteria for day surgery, were excluded', '44 patients completed the study', 'Patients were randomized into two groups: group 1 had']","['transvaginal three-dimensional sonohysterography (3D SHSG) and outpatient hysteroscopy', 'hysteroscopy followed by SHSG while group 2 had SHSG followed by hysteroscopy', 'transvaginal 3D sonohysterography with outpatient hysteroscopy']","['average duration of symptoms', 'Diagnostic accuracy, procedure time, and patient discomfort of SHSG', 'patient acceptability of SHSG', 'abnormal uterine bleeding']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding (disorder)'}, {'cui': 'C0015031', 'cui_str': 'Ethnicity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0030790', 'cui_str': 'Pelvic Infection'}, {'cui': 'C0151994', 'cui_str': 'Enlarged uterus (finding)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282046', 'cui_str': 'Surgery, Day'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0436359', 'cui_str': 'Time symptom lasts (observable entity)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding (disorder)'}]",49.0,0.0649403,However patient acceptability of SHSG was significantly more when compared to outpatient hysteroscopy.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Katsetos', 'Affiliation': 'Minimal Invasive Therapy Unit and Early Pregnancy Unit, Royal Free Hospital, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Radhakrishnan', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Koumousidis', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kontoyannis', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Sanoulis', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spaliaras', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kouvelas', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
962,23724518,Evaluation of low-dose letrozole addition to ovulation induction in IVF.,"PURPOSE


The aim was to investigate the impact of low-dose letrozole usage along with gonadotropin treatment in vitro fertilization (IVF) cycles in comparison to gonadotropin treatment alone.
MATERIALS AND METHODS


Fifty patients were prospectively included in this randomized study and were divided into two groups. Age, demographic features, causes, and period of infertility were adjusted and matched for both groups. Group 1 included 25 patients who received gonadotropin treatment and letrozole along with gonadotropin-releasing hormone (GnRH) antagonist protocol; group 2 included 25 patients who received gonadotropin treatment along with GnRH antagonist protocol.
RESULTS


Total follicle-stimulating hormone (FSH) and daily FSH doses were lower in group 1, although not statistically significant (p > 0.05). The period of ovulation induction was significantly shorter in group 2. While numbers of retrieved oocytes and transferred embryos were lower in group 1, they were not statistically significant (p > 0.05). Number of clinical pregnancies per embryo transfer, number of clinical pregnancies per cycle, and number of ongoing pregnancies (> 16 gestational weeks) were similar in both groups (p > 0.05).
CONCLUSIONS


Addition of low-dose letrozole to gonadotropin treatment in GnRH antagonist protocols may result in a lower dose of gonadotropin administration. However, routine clinical practice remains questionable due to no evident positive effect on pregnancy rates.",2013,"RESULTS


Total follicle-stimulating hormone (FSH) and daily FSH doses were lower in group 1, although not statistically significant (p > 0.05).","['IVF', 'Fifty patients']","['gonadotropin treatment along with GnRH antagonist protocol', 'gonadotropin treatment and letrozole along with gonadotropin-releasing hormone (GnRH) antagonist protocol', 'gonadotropin', 'letrozole', 'gonadotropin treatment alone']","['numbers of retrieved oocytes and transferred embryos', 'vitro fertilization (IVF) cycles', 'Number of clinical pregnancies per embryo transfer, number of clinical pregnancies per cycle, and number of ongoing pregnancies', 'period of ovulation induction', 'Total follicle-stimulating hormone (FSH) and daily FSH doses']","[{'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0029967', 'cui_str': 'Ovulation Induction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",50.0,0.0526048,"RESULTS


Total follicle-stimulating hormone (FSH) and daily FSH doses were lower in group 1, although not statistically significant (p > 0.05).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Yasa', 'Affiliation': 'Department of Obstetrics and Gynecology, Istanbul University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bastu', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Dural', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Celik', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ergun', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
963,23366836,Transcranial direct current stimulation and EEG-based motor imagery BCI for upper limb stroke rehabilitation.,"Clinical studies had shown that EEG-based motor imagery Brain-Computer Interface (MI-BCI) combined with robotic feedback is effective in upper limb stroke rehabilitation, and transcranial Direct Current Stimulation (tDCS) combined with other rehabilitation techniques further enhanced the facilitating effect of tDCS. This motivated the current clinical study to investigate the effects of combining tDCS with MI-BCI and robotic feedback compared to sham-tDCS for upper limb stroke rehabilitation. The stroke patients recruited were randomized to receive 20 minutes of tDCS or sham-tDCS prior to 10 sessions of 1-hour MI-BCI with robotic feedback for 2 weeks. The online accuracies of detecting motor imagery from idle condition were assessed and offline accuracies of classifying motor imagery from background rest condition were assessed from the EEG of the evaluation and therapy parts of the 10 rehabilitation sessions respectively. The results showed no evident differences between the online accuracies on the evaluation part from both groups, but the offline analysis on the therapy part yielded higher averaged accuracies for subjects who received tDCS (n=3) compared to sham-tDCS (n=2). The results suggest towards tDCS effect in modulating motor imagery in stroke, but a more conclusive result can be drawn when more data are collected in the ongoing study.",2012,The online accuracies of detecting motor imagery from idle condition were assessed and offline accuracies of classifying motor imagery from background rest condition were assessed from the EEG of the evaluation and therapy parts of the 10 rehabilitation sessions respectively.,"['stroke patients', 'upper limb stroke rehabilitation']","['EEG-based motor imagery Brain-Computer Interface (MI-BCI) combined with robotic feedback', 'tDCS or sham-tDCS', 'tDCS', 'Transcranial direct current stimulation and EEG-based motor imagery BCI', 'sham-tDCS', 'tDCS with MI-BCI and robotic feedback']",[],"[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interfaces'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]",[],,0.0208739,The online accuracies of detecting motor imagery from idle condition were assessed and offline accuracies of classifying motor imagery from background rest condition were assessed from the EEG of the evaluation and therapy parts of the 10 rehabilitation sessions respectively.,"[{'ForeName': 'Kai Keng', 'Initials': 'KK', 'LastName': 'Ang', 'Affiliation': 'Institute for Infocomm Research, Agency for Science, Technology and Research (A*STAR), 1 Fusionopolis Way, #21-01, Connexis, Singapore. kkang@i2r.a-star.edu.sg'}, {'ForeName': 'Cuntai', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': ''}, {'ForeName': 'Kok Soon', 'Initials': 'KS', 'LastName': 'Phua', 'Affiliation': ''}, {'ForeName': 'Chuanchu', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Irvin', 'Initials': 'I', 'LastName': 'Teh', 'Affiliation': ''}, {'ForeName': 'Chang Wu', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Effie', 'Initials': 'E', 'LastName': 'Chew', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2012.6346875']
964,23366886,A comparison of direct and pattern recognition control for a two degree-of-freedom above elbow virtual prosthesis.,"Individuals with a transhumeral amputation have a large functional deficit and require basic functions out of their prosthesis. Myoelectric prostheses have used amplitude control techniques for decades to restore one or two degrees of freedom to these patients. Pattern recognition control has also been investigated for transhumeral amputees, but in recent years, has been more focused on transradial amputees or high-level patients who have received targeted muscle reinnervation. This study seeks to use the most recent advances in pattern recognition control and investigate techniques that could be applied to the majority of the transhumeral amputee population that has not had the reinnervation surgery to determine if pattern recognition systems may provide them with improved control. In this study, able-bodied control subjects demonstrated that highly accurate two degree-of-freedom pattern recognition systems may be trained using four EMG channels. Such systems may be used to better control a prosthesis in real-time when compared to conventional amplitude control with mode switching.",2012,Such systems may be used to better control a prosthesis in real-time when compared to conventional amplitude control with mode switching.,"['transradial amputees or high-level patients who have received targeted muscle reinnervation', 'Individuals with a transhumeral amputation']",['direct and pattern recognition control'],[],"[{'cui': 'C0002695', 'cui_str': 'Amputees'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0231508', 'cui_str': 'Reinnervation (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0134609,Such systems may be used to better control a prosthesis in real-time when compared to conventional amplitude control with mode switching.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Toledo', 'Affiliation': 'Electrical Engineering Department, Bioelectronics Section, CINVESTAV-IPN, Mexico, D.F., Mexico.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Muñoz', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vera', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Leija', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hargrove', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2012.6346925']
965,23366963,Double-blind single-session neurofeedback training in upper-alpha for cognitive enhancement of healthy subjects.,"This paper reports on a single-session neurofeedback (NF) training procedure on the user-specific upper alpha band for cognitive enhancement in healthy users. A double-blind study was designed using a NF group and an active control group. Control group performed as the NF group but received sham feedback, minimizing the non-specific factors of training. This design aimed to (i) investigate upper alpha as a NF parameter, (ii) evaluate the NF effects on upper alpha during the execution of a cognitive task, and (iii) evaluate the effects on cognitive performance by means of a cognitive task and a battery of psychological tests. Results of EEG analysis show the key role of the feedback: only the NF group enhanced upper alpha during the training, and it led to a desynchronization increase during the execution of the cognitive task. Regarding the behavioral results, a strong learning effect was observed, with the NF group performing better in almost all measurements but many of them without statistical significance.",2012,"Results of EEG analysis show the key role of the feedback: only the NF group enhanced upper alpha during the training, and it led to a desynchronization increase during the execution of the cognitive task.","['healthy subjects', 'healthy users']","['NF group but received sham feedback, minimizing the non-specific factors of training', 'Double-blind single-session neurofeedback training']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]",[],,0.018158,"Results of EEG analysis show the key role of the feedback: only the NF group enhanced upper alpha during the training, and it led to a desynchronization increase during the execution of the cognitive task.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Escolano', 'Affiliation': 'Instituto de Investigación en Ingeniería de Aragón-I3A and the Universidad de Zaragoza, Spain. cescolan@unizar.es'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Olivan', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lopez-del-Hoyo', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Garcia-Campayo', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Minguez', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2012.6347002']
966,23367230,Surface EMG analysis and changes in gait following electrical stimulation of quadriceps femoris and tibialis anterior in children with spastic cerebral palsy.,"PURPOSE


To evaluate the clinical feasibility and effect of neuromuscular electrical stimulation (NMES) therapy of quadriceps femoris (QF) and tibialis anterior (TA) muscles on improving gait and functional outcomes in children with spastic cerebral palsy (CP).
METHOD


Ten children with spastic diplegic/hemiplegic CP who were in the age group of 7 to 14 years recruited from a rehabilitation institute were randomly assigned either to a control group or a NMES group. Both groups obtained conventional physiotherapy and muscle strengthening exercises. The NMES group in addition received surface electrical stimulation to QF and TA muscles for four weeks duration.
RESULTS


The NMES group showed significant improvements as compared to the control group in walking speed (mean difference: 7.83 meters per min, 95% confidence interval: 3.13 to 12.53, p&#60;0.01) and cadence (mean difference: 23.33 steps per min, 95% confidence interval: 5.90 to 40.77, p&#60;0.01). The NMES group also showed significant reduction in physiological cost index of walking or PCI (mean difference: -1.32 beats per meter, 95% confidence interval: -1.83 to -0.80, p&#60;0.001) indicating greater energy-efficiency of walking. No significant changes were seen in EMG parameters.
CONCLUSIONS


The findings of this study suggests that NMES therapy together with conventional physiotherapy more efficiently improves walking ability and functional outcomes as compared to conventional physiotherapy alone in children with spastic CP.",2012,"The NMES group showed significant improvements as compared to the control group in walking speed (mean difference: 7.83 meters per min, 95% confidence interval: 3.13 to 12.53, p&#60;0.01) and cadence (mean difference: 23.33 steps per min, 95% confidence interval: 5.90 to 40.77, p&#60;0.01).","['Ten children with spastic diplegic/hemiplegic CP who were in the age group of 7 to 14 years recruited from a rehabilitation institute', 'children with spastic CP', 'children with spastic cerebral palsy', 'children with spastic cerebral palsy (CP']","['neuromuscular electrical stimulation (NMES) therapy of quadriceps femoris (QF) and tibialis anterior (TA) muscles', 'conventional physiotherapy and muscle strengthening exercises', 'NMES']","['walking speed', 'gait and functional outcomes', 'walking ability and functional outcomes', 'physiological cost index of walking or PCI', 'EMG parameters', 'energy-efficiency of walking']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}]","[{'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C0242690', 'cui_str': 'Anterior Tibial Muscle'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",10.0,0.0663358,"The NMES group showed significant improvements as compared to the control group in walking speed (mean difference: 7.83 meters per min, 95% confidence interval: 3.13 to 12.53, p&#60;0.01) and cadence (mean difference: 23.33 steps per min, 95% confidence interval: 5.90 to 40.77, p&#60;0.01).","[{'ForeName': 'Bikas K', 'Initials': 'BK', 'LastName': 'Arya', 'Affiliation': 'School of Medical Science & Technology, Indian Institute of Technology, Kharagpur, India. bikasarya.mm@iitkgp.ac.in'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mohapatra', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Subramanya', 'Affiliation': ''}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Prasad', 'Affiliation': ''}, {'ForeName': 'Ratnesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Manjunatha', 'Initials': 'M', 'LastName': 'Mahadevappa', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2012.6347295']
967,23366357,EHS subjects do not perceive RF EMF emitted from smart phones better than non-EHS subjects.,"As the use of smart phones increases, social concerns have arisen concerning the possible effects of radio frequency-electromagnetic fields (RF-EMFs) emitted from wideband code division multiple access (WCDMA) mobile phones on human health. The number of people with self-reported electromagnetic hypersensitivity (EHS) who complain of various subjective symptoms, such as headache, insomnia, etc., has also recently increased. However, it is unclear whether EHS subjects can detect RF-EMFs exposure or not. In this double-blind study, two volunteer groups of 17 EHS and 20 non-EHS subjects were investigated in regards to their perception of RF-EMFs with real and sham exposure sessions. Experiments were conducted using a WCDMA module inside a dummy phone with an average power of 24 dBm at 1950 MHz and a specific absorption rate of 1.57 W/kg using a dummy headphone for 32 min. In conclusion, there was no indication that EHS subjects perceive RF-EMFs better than non-EHS subjects.",2012,"As the use of smart phones increases, social concerns have arisen concerning the possible effects of radio frequency-electromagnetic fields (RF-EMFs) emitted from wideband code division multiple access (WCDMA) mobile phones on human health.",['two volunteer groups of 17 EHS and 20 non-EHS subjects'],['RF-EMFs with real and sham exposure sessions'],[],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",[],,0.0348572,"As the use of smart phones increases, social concerns have arisen concerning the possible effects of radio frequency-electromagnetic fields (RF-EMFs) emitted from wideband code division multiple access (WCDMA) mobile phones on human health.","[{'ForeName': 'Min Kyung', 'Initials': 'MK', 'LastName': 'Kwon', 'Affiliation': 'Brain Korea 21 Project for Medical Science, Yonsei University, Seoul, Korea. kmk5170@yuhs.ac'}, {'ForeName': 'Sung Kean', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jeong Mo', 'Initials': 'JM', 'LastName': 'Koo', 'Affiliation': ''}, {'ForeName': 'Joon Yul', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Deok Won', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2012.6346396']
968,31771512,Effects of regional anesthesia techniques on local anesthetic plasma levels and complications in carotid surgery: a randomized controlled pilot trial.,"BACKGROUND


The ultrasound guided intermediate cervical plexus block with perivascular infiltration of the internal carotid artery (PVB) is a new technique for regional anesthesia in carotid endarterectomy (CEA). We conducted a pilot study investigating the effects of deep cervical block (DCB), intermediate cervical block alone (ICB) and PVB on perioperative complications in patients undergoing elective CEA. We hypothesized, that the ropivacaine plasma concentration is higher in patients receiving DCB compared to PVB and ICB.
METHODS


In a randomized controlled pilot study thirty patients scheduled for elective CEA were randomly assigned into three groups: DCB receiving 20 mL ropivacaine 0.5% (n = 10), ICB receiving 20 mL ropivacaine 0.5% (n = 10) and PVB receiving 20 mL ropivacaine 0.5% and 10 mL ropivacaine 0,3% (n = 10). As primary outcome, plasma levels of ropivacaine were measured with high performance liquid chromatography before, 5, 10, 20, 60, and 180 min after the injection of ropivacaine. Secondary outcomes were vascular and neurological complications as well as patients' and surgeons' satisfaction. All analyses were performed on an intention-to-treat basis. Statistical significance was accepted at p < 0.05.
RESULTS


No conversion to general anesthesia was necessary and we observed no signs of local anesthetic intoxication or accidental vascular puncture. Plasma concentration of ropivacaine was significantly higher in the DCB group compared to PVB and ICB (p < 0.001) and in the PVB group compared to ICB (p = 0.008). Surgeons' satisfaction was higher in the PVB group compared to ICB (p = 0.003) and patients' satisfaction was higher in the PVB group compared to ICB (p = 0.010) and DCB group (p = 0.029). Phrenic nerve paralysis was observed frequently in the DCB group (p < 0.05). None of these patients with hemi-diaphragmatic paralysis showed signs of respiratory distress.
CONCLUSION


The ultrasound guided PVB is a safe and effective technique for CEA which is associated with lower plasma levels of local anesthetic than the standard DCB. Considering the low rate of complications in all types of regional anesthesia for CEA, larger randomized controlled trials are warranted to assess potential side effects among the blocks.
TRIAL REGISTRATION


The trial was registered at German Clinical Trials Register (DRKS) on 04/05/2019 (DRKS00016705, retrospectively registered).",2019,The ultrasound guided PVB is a safe and effective technique for CEA which is associated with lower plasma levels of local anesthetic than the standard DCB.,"['thirty patients scheduled for elective CEA', 'carotid surgery', 'patients undergoing elective CEA']","['ropivacaine', 'DCB', 'ultrasound guided intermediate cervical plexus block with perivascular infiltration of the internal carotid artery (PVB', 'deep cervical block (DCB), intermediate cervical block alone (ICB) and PVB', 'ICB receiving 20\u2009mL ropivacaine', 'mL ropivacaine', 'PVB receiving 20\u2009mL ropivacaine 0.5% and 10', 'regional anesthesia techniques', 'DCB receiving 20\u2009mL ropivacaine']","['Plasma concentration of ropivacaine', 'perioperative complications', ""patients' satisfaction"", 'local anesthetic plasma levels and complications', 'plasma levels of ropivacaine', 'signs of respiratory distress', 'Phrenic nerve paralysis', ""Surgeons' satisfaction"", 'ropivacaine plasma concentration', ""vascular and neurological complications as well as patients' and surgeons' satisfaction""]","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0394689', 'cui_str': 'Cervical Plexus Anesthesia'}, {'cui': 'C0442165', 'cui_str': 'Perivascular (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C1442879', 'cui_str': 'Phrenic nerve paralysis'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",30.0,0.156617,The ultrasound guided PVB is a safe and effective technique for CEA which is associated with lower plasma levels of local anesthetic than the standard DCB.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rössel', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany. thomas.roessel@ukdd.de.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Uhlig', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Pietsch', 'Affiliation': 'Institute of Legal Medicine, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ludwig', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Richter', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Peter Markus', 'Initials': 'PM', 'LastName': 'Spieth', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Kersting', 'Affiliation': 'Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}]",BMC anesthesiology,['10.1186/s12871-019-0890-8']
969,31711417,The influence of the infusion of ephedrine and phenylephrine on the hemodynamic stability after subarachnoid anesthesia in senior adults - a controlled randomized trial.,"BACKGROUND


We studied the influence of ephedrine or phenylephrine infusion administered immediately after spinal anesthesia (SA) on hemodynamics in elderly orthopedic patients.
METHODS


A prospective, randomized, double-blind, placebo-controlled study. After a subarachnoid injection of 15 mg of levobupivacaine, the participants received an infusion of either ephedrine 20 mg (E group), phenylephrine 250 mcg (P group) or saline (C group) within 30 min. We measured blood pressure, cardiac index (CI) and heart rate (HR) from 15 min before to 30 min after SA.
RESULTS


Seventy patients were included in the final analysis. At the end of measurements, mean arterial pressure (MAP) decreased significantly after SA in comparison to the baseline value in the C group but was maintained in the P and E group, with no significant differences between the groups. CI decreased after SA in the C group, was maintained in the P group, and increased significantly in the E group with significant differences between the C and E group (p = 0.049) also between the P and E (p = 0.01) group at the end of measurements. HR decreased significantly after SA in the C and P group but was maintained in the E group, with significant differences between the P and E group (p = 0.033) at the end of measurements.
CONCLUSIONS


Hemodynamic changes after SA in elderly orthopedic patients can be prevented by an immediate infusion of phenylephrine or ephedrine. In addition to maintaining blood pressure, the ephedrine infusion also maintains HR and increases CI after SA.
TRIAL REGISTRATION


ISRCTN registry with registration number ISRCTN44377602, retrospectively registered on 15 June 2017.",2019,"At the end of measurements, mean arterial pressure (MAP) decreased significantly after SA in comparison to the baseline value in the C group but was maintained in the P and E group, with no significant differences between the groups.","['after subarachnoid anesthesia in senior adults ', 'elderly orthopedic patients', 'Seventy patients were included in the final analysis']","['levobupivacaine', 'ephedrine 20\u2009mg (E group), phenylephrine 250 mcg (P group) or saline', 'ephedrine and phenylephrine', 'ephedrine', 'placebo', 'phenylephrine or ephedrine', 'ephedrine or phenylephrine', 'spinal anesthesia (SA']","['mean arterial pressure (MAP', 'blood pressure', 'HR', 'CI', 'hemodynamic stability', 'blood pressure, cardiac index (CI) and heart rate (HR']","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",70.0,0.156994,"At the end of measurements, mean arterial pressure (MAP) decreased significantly after SA in comparison to the baseline value in the C group but was maintained in the P and E group, with no significant differences between the groups.","[{'ForeName': 'Miodrag', 'Initials': 'M', 'LastName': 'Žunić', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, University Medical Center Maribor, Ljubljanska ulica 5, 2000, Maribor, Slovenia. miodrag.zunic@doctor.com.'}, {'ForeName': 'Nevenka', 'Initials': 'N', 'LastName': 'Krčevski Škvarč', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, University Medical Center Maribor, Ljubljanska ulica 5, 2000, Maribor, Slovenia.'}, {'ForeName': 'Mirt', 'Initials': 'M', 'LastName': 'Kamenik', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Management, University Medical Center Maribor, Ljubljanska ulica 5, 2000, Maribor, Slovenia.'}]",BMC anesthesiology,['10.1186/s12871-019-0878-4']
970,22256165,Gabor filter for enhanced recognition of assisted turning events.,"Nursing facility residents at high risk for pressure ulcers are turned in bed by staff at regular intervals. In an ongoing large, multi-site randomized clinical trial (RCT) the impacts of 2, 3, and 4 hour turning intervals are being studied on pressure ulcer outcomes. In the RCT, it is necessary to objectively confirm the reported times of assisted turning by certified nurse assistants using activity data. Activity peaks in Gaussian-smoothed activity data were unable to confirm all turning events in a supporting pilot study with observer notes of assisted turns. A new technique is presented using one-dimensional Gabor filters that enhances activity peaks due to turning events and diminishes the signal during extended activity. As a result, all assisted turns in the pilot study were detected and confirmed. Moreover, the dependence of detection sensitivity on decision threshold is lowered in this method.",2011,Activity peaks in Gaussian-smoothed activity data were unable to confirm all turning events in a supporting pilot study with observer notes of assisted turns.,['Nursing facility residents at high risk for pressure ulcers'],['Gabor filter'],[],"[{'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}]","[{'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}]",[],,0.0212446,Activity peaks in Gaussian-smoothed activity data were unable to confirm all turning events in a supporting pilot study with observer notes of assisted turns.,"[{'ForeName': 'Nikhil S', 'Initials': 'NS', 'LastName': 'Padhye', 'Affiliation': 'The University of Texas Health Science Center, Houston, Houston, TX 77030, USA. .S.Padhye@uth.tmc.edu'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Mary Pat', 'Initials': 'MP', 'LastName': 'Rapp', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bergstrom', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6091941']
971,22905454,Effect of pravastatin on endothelial function and endothelial progenitor cells in healthy postmenopausal women.,"PURPOSE


Coronary heart disease is the leading cause of morbidity and mortality in postmenopausal women. Among statins, pravastatin has been shown to significantly reduce fatal and non-fatal cardiovascular events in primary and secondary prevention trials. The aim of the present research was to investigate whether treatment with pravastatin can modify some indices of cardiovascular risk in healthy postmenopausal women such as significant reductions in total and LDL cholesterol and triglyceride levels.
METHODS


20 patients were randomized in double-blind fashion to treatment for eight weeks with either pravastatin 40 mg/day or placebo, and subsequently, after one-week wash-out, crossed-over to the alternative treatment (placebo or pravastatin) for the following eight weeks. We performed clinical and laboratory investigations, before and at the end of each treatment period, to evaluate patient response to the treatment with pravastatin.
RESULTS


After eight weeks pravastatin therapy reduced the median low density lipoprotein (LDL) and total cholesterol (p < 0.01 in both cases). In contrast, insulin level and insulin sensitivity did not show any difference with regard to values observed after placebo treatment. The absolute number of endothelial progenitor cells-colony forming unit (EPC-CFU) was significantly increased by pravastatin treatment (30.6% increase, p < 0.05) and the number of senescent cells was significantly decreased. However pravastatin did not increase tube-like formation by EPC and did not improve endothelial function.
CONCLUSIONS


Despite beneficial effect on lipids and EPC, short term pravastatin does not seem to improve other cardiovascular risk factors, at least in healthy postmenopausal women.",2012,"The absolute number of endothelial progenitor cells-colony forming unit (EPC-CFU) was significantly increased by pravastatin treatment (30.6% increase, p < 0.05) and the number of senescent cells was significantly decreased.","['healthy postmenopausal women', '20 patients', 'postmenopausal women']","['pravastatin 40 mg/day or placebo', 'pravastatin', 'alternative treatment (placebo or pravastatin']","['number of senescent cells', 'cardiovascular risk factors', 'endothelial function', 'endothelial function and endothelial progenitor cells', 'total and LDL cholesterol and triglyceride levels', 'median low density lipoprotein (LDL) and total cholesterol', 'absolute number of endothelial progenitor cells-colony forming unit (EPC-CFU', 'insulin level and insulin sensitivity']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}]",20.0,0.12145,"The absolute number of endothelial progenitor cells-colony forming unit (EPC-CFU) was significantly increased by pravastatin treatment (30.6% increase, p < 0.05) and the number of senescent cells was significantly decreased.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Paradisi', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy. giancarlo.paradisi@tin.it'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bracaglia', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Basile', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': ""Di'Ipolito"", 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Di Nicuolo', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ianniello', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Quagliozzi', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Donati', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Labianca', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Di Cesare', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Viggiano', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Biaggi', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'De Waure', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Andreotti', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Di Simone', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caruso', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
972,32109179,"The Effects of Bioavailable Curcumin (Cureit) on Delayed Onset Muscle Soreness Induced By Eccentric Continuous Exercise: A Randomized, Placebo-Controlled, Double-Blind Clinical Study.","Delayed onset muscle soreness (DOMS) is a multifactorial progression related to muscle pain, swelling, stiffness, tenderness, altered joint kinematics, muscle fiber disruption, decreased strength and power, and acute tissue damage. Curcumin, a natural phytonutrient, could manage DOMS induced by eccentric continuous exercise due to its wide range of biological activities. This study was a randomized, placebo-controlled, double-blind clinical study to assess the efficacy of Cureit™-a bioavailable form of curcumin that may decrease damage from inflammation and oxidative stress associated with severe muscle damage induced by continuous eccentric exercise. The results of the study showed that oral consumption of Cureit significantly reduced DOMS, slightly reduced creatinine kinase concentrations, and slightly increased VO 2  max value compared with placebo, and found safe for administration. The consumption of Cureit led to improved recovery and reduction of DOMS without any side effects due to the enhancement of bioavailable form of curcumin.",2020,"The results of the study showed that oral consumption of Cureit significantly reduced DOMS, slightly reduced creatinine kinase concentrations, and slightly increased VO 2  max value compared with placebo, and found safe for administration.",['Delayed Onset Muscle Soreness Induced By Eccentric Continuous Exercise'],"['placebo', 'Bioavailable Curcumin (Cureit', 'Placebo']","['strength and power, and acute tissue damage', 'creatinine kinase concentrations', 'DOMS', 'Delayed onset muscle soreness (DOMS']","[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]",,0.244405,"The results of the study showed that oral consumption of Cureit significantly reduced DOMS, slightly reduced creatinine kinase concentrations, and slightly increased VO 2  max value compared with placebo, and found safe for administration.","[{'ForeName': 'Augustine', 'Initials': 'A', 'LastName': 'Amalraj', 'Affiliation': 'R&D Centre, Aurea Biolabs Private Limited, Kolenchery, Cochin, Kerala, India.'}, {'ForeName': 'Chandradhara', 'Initials': 'C', 'LastName': 'Divya', 'Affiliation': 'BioAgile Therapeutics Private Limited, Bangalore, Karnataka, India.'}, {'ForeName': 'Sreeraj', 'Initials': 'S', 'LastName': 'Gopi', 'Affiliation': 'R&D Centre, Aurea Biolabs Private Limited, Kolenchery, Cochin, Kerala, India.'}]",Journal of medicinal food,['10.1089/jmf.2019.4533']
973,22675955,"The efficacy of paracetamol versus tenoxicam on postoperative pain and morphine consumption after abdominal hysterectomy: a placebo-controlled, randomized study.","OBJECTIVE


The purpose of this study was to determine the analgesic efficacy and side-effects of paracetamol and tenoxicam in comparison with placebo in patients with postoperative pain after elective abdominal hysterectomy.
MATERIAL AND METHODS


A total of 120 patients were randomly divided into three groups to receive either paracetamol 1 g, tenoxicam 20 mg or placebo intravenously at the end of surgery, and then morphine was administered by a patient-controlled analgesia device postoperatively.
RESULTS


Tenoxicam was associated with lower pain scores at the 2nd, 4th, 6th and 24th hour postoperatively. Total morphine consumption was 44.8 +/- 17.4 mg, 64.6 +/- 19.6 mg, 69.2 +/- 22.1 (tenoxicam, paracetamol and placebo group, respectively) and there was a significant difference in the tenoxicam group compared with the other two groups (p < 0.05). Side-effects except for nausea were similar.
CONCLUSION


A single dose of 20 mg tenoxicam provided effective analgesia and reduced total morphine consumption in comparison with paracetamol and placebo after abdominal hysterectomy.",2012,A single dose of 20 mg tenoxicam provided effective analgesia and reduced total morphine consumption in comparison with paracetamol and placebo after abdominal hysterectomy.,"['A total of 120 patients', 'after abdominal hysterectomy', 'patients with postoperative pain after elective abdominal hysterectomy']","['morphine', 'placebo', 'paracetamol and tenoxicam', 'paracetamol and placebo', '22.1 (tenoxicam, paracetamol and placebo', 'paracetamol versus tenoxicam', 'paracetamol 1 g, tenoxicam 20 mg or placebo']","['Total morphine consumption', 'nausea', 'analgesic efficacy', 'total morphine consumption', 'postoperative pain and morphine consumption', 'lower pain scores']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0076096', 'cui_str': 'tenoxicam'}, {'cui': 'C1130296', 'cui_str': 'tenoxicam 20 MG'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",120.0,0.180197,A single dose of 20 mg tenoxicam provided effective analgesia and reduced total morphine consumption in comparison with paracetamol and placebo after abdominal hysterectomy.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Gunusen', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ege University Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Karaman', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Acar', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sargin', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Firat', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
974,22675960,Comparison of propofol/ketamine versus propofol/alfentanil for dilatation and curettage.,"BACKGROUND AND OBJECTIVES


The use of propofol with an analgesic agent is probably the principal technique for the induction of anesthesia for dilatation and curettage (D&C) at the present time. We designed a randomized, double-blind study to compare the clinical efficacy of ketamine and alfentanil when combined with propofol for short-lasting anesthesia during D&C.
METHODS


The study included 60 patients scheduled for D&C. Either alfentanil 10 microg/kg(-1) IV (Group A) or ketamine 0.5 mg/kg(-1) IV (Group K) were given to each patient with propofol 0.7 mg/kg(-1) IV for anesthesia induction. Surgeon and patient satisfaction, Aldrete score, Verbal Pain Scale rating, total propofol dose, orientation time, and adverse events such as bradycardia, hypotension, nausea, and vomiting were evaluated.
RESULTS


In Group A orientation time was significantly shorter and propofol consumption significantly lower than in Group K.
CONCLUSIONS


Both alfentanil/propofol and ketamine/propofol combinations provide reliable and effective hypnosis and analgesia; however, the ketamine/propofol combination leads to higher consumption of propofol and results in a longer orientation time than the alfentanil/propofol combination.",2012,"In Group A orientation time was significantly shorter and propofol consumption significantly lower than in Group K.
CONCLUSIONS


","['dilatation and curettage', '60 patients scheduled for D&C']","['propofol 0.7 mg/kg(-1) IV for anesthesia induction', 'alfentanil 10 microg/kg(-1) IV (Group A) or ketamine 0.5 mg/kg(-1', 'alfentanil/propofol and ketamine/propofol', 'ketamine and alfentanil', 'propofol', 'propofol/alfentanil', 'propofol/ketamine']","['Surgeon and patient satisfaction, Aldrete score, Verbal Pain Scale rating, total propofol dose, orientation time, and adverse events such as bradycardia, hypotension, nausea, and vomiting', 'propofol consumption']","[{'cui': 'C0012358', 'cui_str': 'D&C'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0002026', 'cui_str': 'Alfentanil'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",60.0,0.034404,"In Group A orientation time was significantly shorter and propofol consumption significantly lower than in Group K.
CONCLUSIONS


","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sahin', 'Affiliation': 'Department of Anesthesiology, Gaziantep University, Faculty of Medicine, Gaziantep, Turkey. drlsahin@hotmail.com'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sahin', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Aktas', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kilic', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mandollu', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
975,22675968,Comparison of diclofenac sodium with indomethacin suppositories for mediolateral episiotomies.,"OBJECTIVE


The study was carried out to compare the analgesic effect of diclofenac sodium and indomethacin suppositories for management of right mediolateral episiotomy repair.
METHOD


A total of 70 patients who gave birth vaginally with right mediolateral episitomy were randomly assigned to receive 100 mg diclofenac sodium suppositories/day (G1, n = 35) or 100 mg indomethacin supposotories/day (G2, n = 35) after episiotomy repair and postpartum for three days. Pain ratings were recorded before, the first hour and 24 hours after medication. The verbal rating scale (VRS) and visual analog scale (VAS) were used for pain recording. The independent T test, Mann-Whitney U and Wilcoxon rank test were used for statistical analysis and Spearman correlation analysis was used for comparison between VRS and VAS.
RESULTS


Diclofenac sodium was a more effective analgesic than indomethacin suppositories for right mediolateral episiotomy pain. For G1 the first hour VRS was 2.6 +/- 0.5 points and VAS 4.9 +/- 0.8 points; for G2 the first hour VRS was 3.4 +/- 0.6 points VAS 6.6 +/- 1.2 points; this difference was statistically significant (p < 0.05, Mann-Whitney U test). For G1 at the 24th hour VRS was 1.2 +/- 0.4 points and VAS 2.4 +/- 0.9 points; for G2 at the 24th hour VRS was 2 +/- 0.7 points and VAS was 3.4 +/- 1.3 points; the difference was statistically significant (p < 0.05, Mann-Whitney U test). The first and 24th hour pain scores (VAS1-VAS24, VRS1-VRS24) were decreased dramatically for both groups (p < 0.05, Wilcoxon rank test). A positive correlation was obtained between the first and 24th hour VRS and VAS by Spearman correlation analysis (r(s) = 0.9, n = 70, p = 0.000).
CONCLUSION


The two analgesics were effective after episiotomy repair, however diclofenac sodium suppositories may be the preferred choice because they were more effective.",2012,"RESULTS


Diclofenac sodium was a more effective analgesic than indomethacin suppositories for right mediolateral episiotomy pain.","['mediolateral episiotomies', '70 patients who gave birth vaginally with right mediolateral episitomy']","['diclofenac sodium suppositories/day (G1, n = 35) or 100 mg indomethacin supposotories', 'diclofenac sodium and indomethacin suppositories', 'Diclofenac sodium', 'diclofenac sodium suppositories', 'diclofenac sodium with indomethacin suppositories', 'indomethacin suppositories']","['right mediolateral episiotomy pain', 'pain scores (VAS1-VAS24, VRS1-VRS24', 'verbal rating scale (VRS) and visual analog scale (VAS', 'Pain ratings']","[{'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]","[{'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}]","[{'cui': 'C0404377', 'cui_str': 'Right mediolateral episiotomy (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale (assessment scale)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",70.0,0.0231291,"RESULTS


Diclofenac sodium was a more effective analgesic than indomethacin suppositories for right mediolateral episiotomy pain.","[{'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Altungül', 'Affiliation': 'Department of Obstetrics and Gynecology, Maltepe University, Istanbul, Turkey.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sapmaz', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kale', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
976,31541426,A 1-day acceptance and commitment therapy workshop leads to reductions in emotional eating in adults.,"PURPOSE


Emotional eating has been defined as the tendency to overeat in response to negative emotions and is a symptom of emotion dysregulation. Interventions for emotional eating have been developed based on acceptance and commitment therapy (ACT). However, these interventions only address emotional eating in the context of weight loss programs and are therefore not available in a weight neutral context.
METHODS


The present study aimed to test the feasibility and acceptability of a 1-day ACT workshop that taught skills to reduce emotional eating, without promoting weight loss. The workshop was delivered in a single day and aimed to reduce emotional eating by improving values clarification and commitment, acceptance, and mindfulness. Follow-ups were conducted at 2 weeks and 3 months post-intervention.
RESULTS


Results suggest feasibility and acceptability of the 1-day workshop; participants described appreciating the brevity of the program and its applicability to their everyday lives. Improvements in emotional eating were found at 2 weeks (t(31) = 5.80, p < 0.001) and 3 months (t(29) = 6.96, p < 0.001). A repeated measures MANOVA revealed a significant main effect of time (F(14, 96) = 4.98, p < 0.001, partial η 2  = 0.421), with follow-up ANOVAs indicating that this effect held for all variables.
CONCLUSION


The results from this study can be used to inform a larger-scale randomized controlled trial to determine the efficacy of the program in a larger sample and eventually disseminate it in other real-world settings.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03744780.
LEVEL OF EVIDENCE


Level IV, evidence obtained from multiple time series with the intervention.",2020,"Improvements in emotional eating were found at 2 weeks (t(31) = 5.80, p < 0.001) and 3 months (t(29) = 6.96, p < 0.001).",['emotional eating in adults'],['1-day ACT workshop'],"['emotional eating, without promoting weight loss', 'emotional eating']","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0988511,"Improvements in emotional eating were found at 2 weeks (t(31) = 5.80, p < 0.001) and 3 months (t(29) = 6.96, p < 0.001).","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Frayn', 'Affiliation': 'Department of Psychology, McGill University, 2001 McGill College, Montreal, QC, H3A 1G1, Canada. mallory.frayn@mail.mcgill.ca.'}, {'ForeName': 'Sabrah', 'Initials': 'S', 'LastName': 'Khanyari', 'Affiliation': 'Department of Psychology, McGill University, 2001 McGill College, Montreal, QC, H3A 1G1, Canada.'}, {'ForeName': 'Bärbel', 'Initials': 'B', 'LastName': 'Knäuper', 'Affiliation': 'Department of Psychology, McGill University, 2001 McGill College, Montreal, QC, H3A 1G1, Canada.'}]",Eating and weight disorders : EWD,['10.1007/s40519-019-00778-6']
977,31509674,A Randomized Trial of Prenatal n-3 Fatty Acid Supplementation and Preterm Delivery.,"BACKGROUND


Previous studies have suggested that maternal supplementation with n-3 long-chain polyunsaturated fatty acids may reduce the incidence of preterm delivery but may also prolong gestation beyond term; however, more data are needed regarding the role of n-3 long-chain polyunsaturated fatty acids in pregnancy.
METHODS


We performed a multicenter, double-blind, randomized trial in which women who were pregnant with single or multiple fetuses were assigned to receive either fish-oil capsules that contained 900 mg of n-3 long-chain polyunsaturated fatty acids (n-3 group) or vegetable-oil capsules that contained trace n-3 long-chain polyunsaturated fatty acids (control group) daily, beginning before 20 weeks of gestation and continuing to 34 weeks of gestation or delivery, whichever occurred first. The primary outcome was early preterm delivery, defined as delivery before 34 completed weeks of gestation. Other pregnancy and neonatal outcomes were also assessed.
RESULTS


A total of 5544 pregnancies in 5517 women were randomly assigned at six centers in Australia; 5486 pregnancies were included in the primary analysis. Early preterm delivery occurred in the case of 61 of 2734 pregnancies (2.2%) in the n-3 group and 55 of 2752 pregnancies (2.0%) in the control group; the between-group difference was not significant (adjusted relative risk, 1.13; 95% confidence interval [CI], 0.79 to 1.63; P = 0.50). There were no significant differences between the groups in the incidence of interventions in post-term (>41 weeks of gestation) deliveries, in adverse events, or in other pregnancy or neonatal outcomes, except that a higher percentage of infants born to women in the n-3 group than in the control group were very large for gestational age at birth (adjusted relative risk, 1.30; 95% CI, 1.02 to 1.65). Percentages of serious adverse events did not differ between the groups. Minor gastrointestinal disturbances were more commonly reported in the n-3 group than in the control group.
CONCLUSIONS


Supplementation with n-3 long-chain polyunsaturated fatty acids from early pregnancy (<20 weeks of gestation) until 34 weeks of gestation did not result in a lower incidence of early preterm delivery or a higher incidence of interventions in post-term deliveries than control. (Funded by the Australian National Health and Medical Research Council and the Thyne Reid Foundation; ORIP Australian New Zealand Clinical Trials Registry number, ACTRN12613001142729.).",2019,"There were no significant differences between the groups in the incidence of interventions in post-term (>41 weeks of gestation) deliveries, in adverse events, or in other pregnancy or neonatal outcomes, except that a higher percentage of infants born to women in the n-3 group than in the control group were very large for gestational age at birth (adjusted relative risk, 1.30; 95% CI, 1.02 to 1.65).","['women who were pregnant with single or multiple fetuses', 'A total of 5544 pregnancies in 5517 women were randomly assigned at six centers in Australia; 5486 pregnancies were included in the primary analysis']","['fish-oil capsules that contained 900 mg of n-3 long-chain polyunsaturated fatty acids (n-3 group) or vegetable-oil capsules that contained trace n-3 long-chain polyunsaturated fatty acids', 'n-3 long-chain polyunsaturated fatty acids', 'Prenatal n-3 Fatty Acid Supplementation and Preterm Delivery']","['early preterm delivery, defined as delivery before 34 completed weeks of gestation', 'gestational age at birth', 'adverse events', 'Percentages of serious adverse events', 'Early preterm delivery', 'Minor gastrointestinal disturbances']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042438', 'cui_str': 'Vegetable Oils'}, {'cui': 'C0442822', 'cui_str': 'Trace (qualifier value)'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0232459', 'cui_str': 'Impaired digestion'}]",,0.483425,"There were no significant differences between the groups in the incidence of interventions in post-term (>41 weeks of gestation) deliveries, in adverse events, or in other pregnancy or neonatal outcomes, except that a higher percentage of infants born to women in the n-3 group than in the control group were very large for gestational age at birth (adjusted relative risk, 1.30; 95% CI, 1.02 to 1.65).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Best', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Yelland', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McPhee', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Shao', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Quinlivan', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Dodd', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Atkinson', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Huda', 'Initials': 'H', 'LastName': 'Safa', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'van Dam', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Khot', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Gustaaf', 'Initials': 'G', 'LastName': 'Dekker', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Skubisz', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Kean', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Anneka', 'Initials': 'A', 'LastName': 'Bowman', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'McCallum', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Cashman', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gibson', 'Affiliation': ""From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.""}]",The New England journal of medicine,['10.1056/NEJMoa1816832']
978,22254516,Magnetic stimulation for fracture consolidation--clinical study.,"This paper presents a randomized clinical design for evaluating magnetic fields in the consolidation of femoral shaft fractures. The study involved the design and construction of 20 devices (stimulators and placebos) and the development of 3D computer models of stimulated patient's thighs. A total of 64 patients were included in the study. Follow up time was 8 weeks with 1 hour of stimulation a day. The electrical signals estimated in the computer models were magnetic field, current density and voltage for different frequencies and currents. The results revealed 83% consolidated cases, and 7% with nonunion within the stimulation group, and 72% of consolidated cases and 14% with non-union for the control group. The consolidation results of patients who received stimulation were superior in time and number, but were not statistically significant. The values of electrical variables estimated by the computational model were found to be within a range not harmful to the patient (μA/m2, μT, nV).",2011,"The consolidation results of patients who received stimulation were superior in time and number, but were not statistically significant.","['femoral shaft fractures', 'A total of 64 patients were included in the study']","['Magnetic stimulation', '20 devices (stimulators and placebos']",[],"[{'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0175727', 'cui_str': 'Stimulator, device (physical object)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],64.0,0.0213896,"The consolidation results of patients who received stimulation were superior in time and number, but were not statistically significant.","[{'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Moncada', 'Affiliation': 'Instituto Tecnológico Metropolitano, Research Center, Medellin-Colombia. mariamoncada@itm.edu.co'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Sarmiento', 'Affiliation': ''}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Martinez', 'Affiliation': ''}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6090267']
979,22254717,Effects of RF fields emitted from smart phones on cardio-respiratory parameters: a preliminary provocation study.,"This paper describes an experimental setup for evaluating the physiological effects of radiofrequency (RF) emitted from a Wideband Code Division Multiple Access (WCDMA) module with a 24 dBm at 1950 MHz for specific absorption rate (SAR(1g)) of 1.57 W/kg. This provocation study was executed in a double-blind study of two volunteer groups of 10 self-reported electromagnetic hypersensitivity (EHS) and 10 non-EHS subjects under both sham and real exposures in a randomly assigned and counter-balanced order. In the preliminary results, WCDMA RF exposure of 30 min did not have any effects on physiological changes in either group.",2011,"In the preliminary results, WCDMA RF exposure of 30 min did not have any effects on physiological changes in either group.",['two volunteer groups of 10 self-reported electromagnetic hypersensitivity (EHS) and 10 non-EHS subjects under both sham and real exposures in a randomly assigned and counter-balanced order'],"['RF fields emitted from smart phones', 'radiofrequency (RF']",['cardio-respiratory parameters'],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.108609,"In the preliminary results, WCDMA RF exposure of 30 min did not have any effects on physiological changes in either group.","[{'ForeName': 'Min Kyung', 'Initials': 'MK', 'LastName': 'Kwon', 'Affiliation': 'Brain Korea 21 Project for Medical Science, Yonsei University, Seoul, Korea. kmk5170@yuhs.ac'}, {'ForeName': 'Ki Chang', 'Initials': 'KC', 'LastName': 'Nam', 'Affiliation': ''}, {'ForeName': 'Da Som', 'Initials': 'DS', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Kyung Hwan', 'Initials': 'KH', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Deok Won', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6090553']
980,22254748,Improvement of gait & muscle strength with functional electrical stimulation in sub-acute & chronic stroke patients.,"The main objective of this work was to evaluate and compare the effects of Functional Electrical Stimulation (FES) therapy in the walking ability and muscle strength studied by electromyography (EMG) analysis between subacute and chronic stroke patients. Eighteen consecutive hemiplegic patients suffering from foot drop were assigned either to subacute or chronic group. Patients of both groups' were treated according to conventional rehabilitation program combined with FES therapy for 12 weeks. At post-treatment, subacute subjects showed a mean increase in walking speed of 29.4% and chronic subjects of 17.1% and the physiological cost index (PCI), with a reduction of 73.1% in subacute subjects and 46.5 % in chronic subjects. Improvement was also found in cadence, step length, and mean-absolute-value (MAV) and root-mean-square (RMS) of EMG signal of tibialis anterior (TA) muscle in both groups, but subacute subjects improved better compared with chronic subjects. Thus we suggested that an early intervention of FES therapy combined with conventional rehabilitation program (CRP) could significantly improve the gait and muscle strength in stroke survivors.",2011,"Improvement was also found in cadence, step length, and mean-absolute-value (MAV) and root-mean-square (RMS) of EMG signal of tibialis anterior (TA) muscle in both groups, but subacute subjects improved better compared with chronic subjects.","['sub-acute & chronic stroke patients', 'Eighteen consecutive hemiplegic patients suffering from foot drop were assigned either to subacute or chronic group', 'subacute and chronic stroke patients']","['Functional Electrical Stimulation (FES) therapy', 'functional electrical stimulation', 'FES therapy combined with conventional rehabilitation program (CRP', 'conventional rehabilitation program combined with FES therapy']","['cadence, step length, and mean-absolute-value (MAV) and root-mean-square (RMS) of EMG signal of tibialis anterior (TA) muscle', 'physiological cost index (PCI', 'gait and muscle strength', 'walking speed']","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0085684', 'cui_str': 'Foot Drop'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0242690', 'cui_str': 'Anterior Tibial Muscle'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}]",18.0,0.0161876,"Improvement was also found in cadence, step length, and mean-absolute-value (MAV) and root-mean-square (RMS) of EMG signal of tibialis anterior (TA) muscle in both groups, but subacute subjects improved better compared with chronic subjects.","[{'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Sabut', 'Affiliation': 'School of Electronics Engineering, KITT University, Bhubaneswar, India. sukanta207@gmail.com'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sikdar', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mahadevappa', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6090387']
981,22255047,Combined multivariate matching pursuit and support vector machine: a way forward to classify single-sweep evoked potentials?,"Evoked brain potentials averaged over multiple sweeps provide a valuable objective measure of abnormal pain processing due to sensitization of the central nervous system. However, the average procedure cancel out important information regarding phase resetting and non-phase locked oscillations. Hence, assessment of the pain processing could be optimized by analyzing single-sweeps. To develop improved methods to assess single-sweeps, we applied a new approach in one healthy volunteer participating in a placebo controlled study of widespread hyperalgesia induced by perfusion of acid and capsaicin in the esophagus. The evoked potentials were recorded during electrical stimulations in the rectosigmoid colon. Features from the single-sweeps were extracted by a multivariate matching pursuit algorithm with Gabor atoms, and features were discriminated by a support vector machine with a linear kernel. The classification performance for the optimal number of atoms was 95% when discriminating the sensitization response from the placebo response, which was above change level compared to the performance when discriminating the two baseline responses (P < 0.001). The discriminative capacity was increased power in the delta, theta, and alpha frequency bands. This result corresponds to previous characteristics seen in chronic pain patients who exhibit central sensitization. The new approach to classify single-sweeps on a single subject basis might in the future prove to be a useful tool in assessing mechanisms in central sensitization, and could be applied to improve enriched enrollment of study subjects in clinical trial units.",2011,"The discriminative capacity was increased power in the delta, theta, and alpha frequency bands.","['chronic pain patients who exhibit central sensitization', 'healthy volunteer participating in a placebo controlled study of widespread hyperalgesia induced by perfusion of acid and capsaicin in the esophagus']",['Combined multivariate matching pursuit and support vector machine'],['discriminative capacity'],"[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205391', 'cui_str': 'Widespread (qualifier value)'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}]",[],1.0,0.0654909,"The discriminative capacity was increased power in the delta, theta, and alpha frequency bands.","[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Graversen', 'Affiliation': 'Mech-Sense, Department of Gastroenterology & Radiology, Aalborg Hospital, DK-9100 Aalborg, Denmark. cg@mech-sense.com'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brock', 'Affiliation': ''}, {'ForeName': 'Asbjørn Mohr', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': ''}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Farina', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6090898']
982,22255101,The effects of rotational platform training on balance and ADLs.,"Patients with vestibular dysfunction complain of postural instability and disorientation long after the central compensation is thought to be complete. Previously it has been demonstrated that patients with unilateral vestibular loss who orient more to vertical have better perceived functional status. We proposed that performing balance training with surface perturbations at velocities that target the vestibular system would lead to increased reliance on vestibular information, and therefore improve function. The purpose of this study was to determine whether patients who train using repetitive platform perturbations at these vestibular dependent velocities demonstrate improved postural stability and greater functional abilities than patients who perform traditional balance therapy. Twelve subjects with chronic vestibular and balance dysfunction (age 58 ± 15 years; 3 males, 8 females) and 4 healthy control subjects (age 62 ± 23 years; 4 females) participated. Patients were randomized into 3 groups: clinical balance training (CBT n=3) and training with ramp platform perturbations (4 deg amplitude) either at vestibular (1, 2, 4 deg/sec; VESTIB n=6) or at non-vestibular velocities (0.5, 8, 16 deg/sec; Non-VESTIB n=3). The healthy control subjects completed training at vestibular velocities. Subjects' kinematic and kinetic responses to ramp rotational platform perturbations (0.5, 1, 2, 4, 8, 16 deg/sec at 6 deg amplitude), and scores on the Activities-specific Balance Confidence Scale (ABC), Dizziness Handicap Inventory (DHI), Vestibular Activities of Daily Living Scale (VADL) and Functional Gait Assessment (FGA) were compared before and after the 2 week, 3x/week training sessions. Control subjects demonstrated minimal change in orientation to vertical during platform rotations following training. The VESTIB group demonstrated greater improvements in orientation to vertical during ramp perturbations following training than the Non-VESTIB or CBT groups. Both the CBT and VESTIB groups demonstrated improvements on a composite clinical score incorporating the ABC, DHI, VADL, and FGA following training whereas the Non-VESTIB group did not demonstrate improvement. These preliminary results indicate that training using platform rotations may be an effective intervention for improving postural control following vestibular loss. Further research is needed to explore the efficacy of incorporating rotational platform training with clinical balance training.",2011,The VESTIB group demonstrated greater improvements in orientation to vertical during ramp perturbations following training than the Non-VESTIB or CBT groups.,"['Patients with vestibular dysfunction complain of postural instability and disorientation long after the central compensation', 'patients who perform traditional balance therapy', 'Twelve subjects with chronic vestibular and balance dysfunction (age 58 ± 15 years; 3 males, 8 females) and 4 healthy control subjects (age 62 ± 23 years; 4 females) participated', 'patients with unilateral vestibular loss']","['rotational platform training', 'clinical balance training (CBT n=3) and training with ramp platform perturbations']","['postural stability and greater functional abilities', 'orientation to vertical during ramp perturbations', 'composite clinical score incorporating the ABC, DHI, VADL, and FGA', 'Activities-specific Balance Confidence Scale (ABC), Dizziness Handicap Inventory (DHI), Vestibular Activities of Daily Living Scale (VADL) and Functional Gait Assessment (FGA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0233407', 'cui_str': 'Disorientation'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2733457', 'cui_str': 'ABC (activities-specific balance confidence) scale'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",12.0,0.00843215,The VESTIB group demonstrated greater improvements in orientation to vertical during ramp perturbations following training than the Non-VESTIB or CBT groups.,"[{'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Wrisley', 'Affiliation': 'Department of Rehabilitation Sciences, University at Buffalo, NY, USA. Wrisley.d@lynchburg.edu'}, {'ForeName': 'Marilee J', 'Initials': 'MJ', 'LastName': 'Stephens', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6090586']
983,22255233,Contribution of sensory and motor components to motor control asymmetries: an analytical model approach.,"Proprioceptive and motor information contribute to movement representation; however, the equivalence of homologous contralateral information has received little attention. In a recent study using the matching paradigm we showed that upper limb position sense, based on feedback control, is asymmetric and this asymmetry could be associated with a difference in gain between left (L) and right (R) sensorimotor systems. The current results also show that movement sense is asymmetric in males and this asymmetry is dependent on handedness. It is assumed that a difference in gain between each sensorimotor system may be associated with asymmetric kinesthetic representations in cortical areas. Outcomes of models representing position and velocity control respectively suggest that velocity matching may be primarily controlled in a feed forward mode. Furthermore, compatibility between the models representing position control and velocity control also indicate that i) a difference between the L and R motor gains alone is not possible and ii) there must be a difference between the L and R sensory gains. Hence, the results strongly suggest a difference in movement representation between the two hand/hemisphere systems.",2011,"In a recent study using the matching paradigm we showed that upper limb position sense, based on feedback control, is asymmetric and this asymmetry could be associated with a difference in gain between left (L) and right (R) sensorimotor systems.",[],['sensory and motor components to motor control asymmetries'],[],[],"[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]",[],,0.0309661,"In a recent study using the matching paradigm we showed that upper limb position sense, based on feedback control, is asymmetric and this asymmetry could be associated with a difference in gain between left (L) and right (R) sensorimotor systems.","[{'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Martin', 'Affiliation': 'Department of Industrial and OperationsEngineering, University of Michigan, USA. martinbj@umich.edu'}, {'ForeName': 'Diane E', 'Initials': 'DE', 'LastName': 'Adamo', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6091010']
984,31915433,"The Effectiveness, Tolerability, and Safety of Different 1-Day Bowel Preparation Regimens for Pediatric Colonoscopy.","Background


Currently, there is no generally accepted universal protocol for bowel preparation before colonoscopy in children.
Aim


The aim of the study was to compare three different 1-day bowel preparation methods for a pediatric elective colonoscopy in terms of their efficacy, safety, and patient-reported tolerability.
Material and Methods


The study was randomized, prospective, and investigator-blinded. All children aged 10 to 18 years consecutively referred to the tertiary pediatric gastroenterology unit were enrolled. The participants were randomized to receive polyethylene glycol 3350 combined with bisacodyl (PEG-bisacodyl group), or polyethylene glycol 4000 with electrolytes (PEG-ELS group), or sodium picosulphate plus magnesium oxide plus citric acid (NaPico+MgCit group). Bowel preparation was assessed according to the Boston Bowel Preparation Scale (BBPS). For patient tolerability and acceptability, questionnaires were obtained.
Results


One hundred twenty-three children were allocated to three age- and sex-matched groups. All of the patients completed colonoscopies with visualization of the cecum. There was no difference among the groups for the mean BBPS score. A total of 73 patients (59.3%) experienced minor adverse events. No serious adverse events occurred in any group. Nausea was the only symptom more frequent in the PEG-ELS group compared to the NaPico+MgCit group ( p  = 0.04), and apathy was the only symptom more frequent in PEG-bisacodyl than in the NaPico+MgCit group ( p  = 0.04). All of the patients were able to complete 75% or more of the study protocol, and 85.4% were able to complete the full regimen. The acceptability was the highest in the NaPico+MgCit group with respect to the patient's grade for palatability, low volume of the solution, and willingness to repeat the same protocol.
Conclusion


All bowel cleansing methods show similar efficacy. However, because of the higher tolerability and acceptability profile, the NaPico+MgCit-based regimen appears to be the most proper for colonoscopy preparation in children.",2019,"Nausea was the only symptom more frequent in the PEG-ELS group compared to the NaPico+MgCit group ( p  = 0.04), and apathy was the only symptom more frequent in PEG-bisacodyl than in the NaPico+MgCit group ( p  = 0.04).","['All children aged 10 to 18 years consecutively referred to the tertiary pediatric gastroenterology unit were enrolled', 'Pediatric Colonoscopy', 'One hundred twenty-three children were allocated to three age- and sex-matched groups']","['polyethylene glycol 3350 combined with bisacodyl (PEG-bisacodyl group), or polyethylene glycol 4000 with electrolytes (PEG-ELS group), or sodium picosulphate plus magnesium oxide plus citric acid (NaPico+MgCit group', 'NaPico+MgCit']","['mean BBPS score', 'minor adverse events', 'serious adverse events', 'Effectiveness, Tolerability, and Safety', 'Boston Bowel Preparation Scale (BBPS', 'Nausea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1636281', 'cui_str': 'Pediatric gastroenterology'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0724672', 'cui_str': 'POLYETHYLENE GLYCOL 3350'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0005632', 'cui_str': 'Bisacodyl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032479', 'cui_str': 'polyethylene glycol 4000'}, {'cui': 'C0013832', 'cui_str': 'Electrolytes'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",123.0,0.0726099,"Nausea was the only symptom more frequent in the PEG-ELS group compared to the NaPico+MgCit group ( p  = 0.04), and apathy was the only symptom more frequent in PEG-bisacodyl than in the NaPico+MgCit group ( p  = 0.04).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Szaflarska-Popławska', 'Affiliation': 'Department of Pediatric Endoscopy and Gastrointestinal Function Testing, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Tunowska', 'Affiliation': 'Department of Pediatrics, Allergology and Gastroenterology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Sobieska-Poszwa', 'Affiliation': 'Department of Pediatrics, Allergology and Gastroenterology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Krogulska', 'Affiliation': 'Department of Pediatrics, Allergology and Gastroenterology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland.'}]",Gastroenterology research and practice,['10.1155/2019/3230654']
985,31791239,"Efficacy of premedication with intranasal dexmedetomidine for removal of inhaled foreign bodies in children by flexible fiberoptic bronchoscopy: a randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


Tracheobronchial foreign body aspiration in children is a life-threatening, emergent situation. Currently, the use of fiberoptic bronchoscopy for removing foreign bodies is attracting increasing attention. Oxygen desaturation, body movement, laryngospasm, bronchospasm, and breath-holding are common adverse events during foreign body removal. Dexmedetomidine, as a highly selective α 2 -adrenergic agonist, produces sedative and analgesic effects, and does not induce respiratory depression. We hypothesized that intranasal dexmedetomidine at 1 μg kg - 1 administered 25 min before anesthesia induction can reduce the incidence of adverse events during fiberoptic bronchoscopy under inhalation general anesthesia with sevoflurane.
METHODS


In all, 40 preschool-aged children (6-48 months) with an American Society of Anesthesiologists physical status of I or II were randomly allocated to receive either intranasal dexmedetomidine at 1 μg·kg - 1 or normal saline at 0.01 ml kg - 1  25 min before anesthesia induction. The primary outcome was the incidence of perioperative adverse events. Heart rate, respiratory rate, parent-child separation score, tolerance of the anesthetic mask, agitation score, consumption of sevoflurane, and recovery time were also recorded.
RESULTS


Following pre-anesthesia treatment with either intranasal dexmedetomidine or saline, the incidences of laryngospasm (15% vs. 50%), breath-holding (10% vs. 40%), and coughing (5% vs. 30%) were significantly lower in patients given dexmedetomidine than those given saline. Patients who received intranasal dexmedetomidine had a lower parent-child separation score (P = 0.017), more satisfactory tolerance of the anesthetic mask (P = 0.027), and less consumption of sevoflurane (38.18 ± 14.95 vs. 48.03 ± 14.45 ml, P = 0.041). The frequency of postoperative agitation was significantly lower in patients given intranasal dexmedetomidine (P = 0.004), and the recovery time was similar in the two groups.
CONCLUSIONS


Intranasal dexmedetomidine 1 μg·kg - 1 , with its sedative and analgesic effects, reduced the incidences of laryngospasm, breath-holding, and coughing during fiberoptic bronchoscopy for FB removal. Moreover, it reduced postoperative agitation without a prolonged recovery time.
TRAIL REGISTRATION


The study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800017273) on July 20, 2018.",2019,"The frequency of postoperative agitation was significantly lower in patients given intranasal dexmedetomidine (P = 0.004), and the recovery time was similar in the two groups.
","['40 preschool-aged children (6-48\u2009months) with an American Society of Anesthesiologists physical status of I or II', 'children by flexible fiberoptic bronchoscopy']","['dexmedetomidine', 'Dexmedetomidine', 'fiberoptic bronchoscopy', 'intranasal dexmedetomidine', 'placebo', 'Tracheobronchial foreign body aspiration', 'sevoflurane', 'intranasal dexmedetomidine or saline', 'Intranasal dexmedetomidine', 'intranasal dexmedetomidine at 1\xa0μg·kg\u2009-\u20091 or normal saline at 0.01']","['postoperative agitation', 'Heart rate, respiratory rate, parent-child separation score, tolerance of the anesthetic mask, agitation score, consumption of sevoflurane, and recovery time', 'coughing', 'Oxygen desaturation, body movement, laryngospasm, bronchospasm, and breath-holding', 'satisfactory tolerance of the anesthetic mask', 'lower parent-child separation score', 'incidences of laryngospasm, breath-holding, and coughing', 'consumption of sevoflurane', 'frequency of postoperative agitation', 'incidence of perioperative adverse events', 'breath-holding', 'recovery time']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1301741', 'cui_str': 'Flexible fiberoptic bronchoscopy'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0189391', 'cui_str': 'Fiberoptic bronchoscopy (procedure)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0450123', 'cui_str': 'Tracheobronchial (qualifier value)'}, {'cui': 'C0232070', 'cui_str': 'Foreign body aspiration'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C4517393', 'cui_str': '0.01'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0235744', 'cui_str': 'Breath Holding'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.689323,"The frequency of postoperative agitation was significantly lower in patients given intranasal dexmedetomidine (P = 0.004), and the recovery time was similar in the two groups.
","[{'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Anesthesiology, West China Second University Hospital, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Yushan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, West China Second University Hospital, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'Department of Anesthesiology, West China Second University Hospital, Sichuan University, Chengdu, Sichuan Province, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, West China Second University Hospital, Sichuan University, Chengdu, Sichuan Province, China. lwu2019@163.com.'}]",BMC anesthesiology,['10.1186/s12871-019-0892-6']
986,31387081,"The Acute Effects of a ""Reduced Sitting Preschool Day"" on Executive Function and Musculoskeletal Health in Preschoolers: A Randomized Cross-Over Study.","PURPOSE


To examine the acute effects of a reduced sitting day on executive function (EF) and musculoskeletal health in preschoolers.
METHODS


A sample of 29 children (54% boys; 4-5 y) participated in a randomized cross-over trial. Each child completed 2 protocols, which simulate a day at childcare in random order for 2.5 hours; a typical preschool day (50% sitting) and a reduced preschool day (25% sitting) where most sitting activities were replaced with standing activities. Sitting, standing, and stepping time were objectively assessed using an activPAL accelerometer. EF was evaluated using tablet-based EF assessments (inhibition, working memory, and task shifting). Musculoskeletal health was assessed using a handheld dynamometer and goniometer.
RESULTS


Compared with the typical preschool day, the reduced sitting day showed no significant differences for EF scores. Effect sizes for inhibition (d = 0.04), working memory (d = 0.02), and shifting (d = 0.11) were all small. For musculoskeletal health, no significant differences were reported after the reduced preschool day. The effect sizes for the hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg were all small (d = 0.21, d = 0.25, d = 0.28, and d = 0.28).
CONCLUSIONS


This study suggests that reducing sitting time is unlikely to result in acute changes in EF and musculoskeletal health among preschoolers.",2019,"The effect sizes for the hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg were all small (d = 0.21, d = 0.25, d = 0.28, and d = 0.28).
","['29 children (54% boys; 4-5\xa0y', 'preschoolers', 'Preschoolers']",['Reduced Sitting Preschool Day'],"['Musculoskeletal health', 'EF scores', 'working memory', 'Executive Function and Musculoskeletal Health', 'hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg', 'Sitting, standing, and stepping time', 'executive function (EF) and musculoskeletal health']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",29.0,0.149474,"The effect sizes for the hip extension force, hamstring flexibility, gastrocnemius length, and balancing on 1 leg were all small (d = 0.21, d = 0.25, d = 0.28, and d = 0.28).
","[{'ForeName': 'Yvonne G', 'Initials': 'YG', 'LastName': 'Ellis', 'Affiliation': 'University of Wollongong.'}, {'ForeName': 'Dylan P', 'Initials': 'DP', 'LastName': 'Cliff', 'Affiliation': 'University of Wollongong.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Howard', 'Affiliation': 'University of Wollongong.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Okely', 'Affiliation': 'University of Wollongong.'}]",Pediatric exercise science,['10.1123/pes.2018-0239']
987,22449293,Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.,"BACKGROUND


A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. This approach may also simplify the treatment of pulmonary embolism.
METHODS


In a randomized, open-label, event-driven, noninferiority trial involving 4832 patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding.
RESULTS


Rivaroxaban was noninferior to standard therapy (noninferiority margin, 2.0; P=0.003) for the primary efficacy outcome, with 50 events in the rivaroxaban group (2.1%) versus 44 events in the standard-therapy group (1.8%) (hazard ratio, 1.12; 95% confidence interval [CI], 0.75 to 1.68). The principal safety outcome occurred in 10.3% of patients in the rivaroxaban group and 11.4% of those in the standard-therapy group (hazard ratio, 0.90; 95% CI, 0.76 to 1.07; P=0.23). Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P=0.003). Rates of other adverse events were similar in the two groups.
CONCLUSIONS


A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile. (Funded by Bayer HealthCare and Janssen Pharmaceuticals; EINSTEIN-PE ClinicalTrials.gov number, NCT00439777.).",2012,"Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P=0.003).","['4832 patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared', 'symptomatic pulmonary embolism']","['Oral rivaroxaban', 'rivaroxaban ', 'Rivaroxaban', 'enoxaparin', 'rivaroxaban']","['principal safety outcome', 'Rates of other adverse events', 'Major bleeding', 'nonmajor bleeding', 'symptomatic recurrent venous thromboembolism']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0401925', 'cui_str': 'Teaching principal (occupation)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}]",4832.0,0.196631,"Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P=0.003).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Büller', 'Affiliation': ''}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Prins', 'Affiliation': ''}, {'ForeName': 'Anthonie W A', 'Initials': 'AW', 'LastName': 'Lensin', 'Affiliation': ''}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Decousus', 'Affiliation': ''}, {'ForeName': 'Barry F', 'Initials': 'BF', 'LastName': 'Jacobson', 'Affiliation': ''}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Minar', 'Affiliation': ''}, {'ForeName': 'Jaromir', 'Initials': 'J', 'LastName': 'Chlumsky', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': ''}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Wells', 'Affiliation': ''}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Agnelli', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': ''}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Bounameaux', 'Affiliation': ''}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Davidson', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Misselwitz', 'Affiliation': ''}, {'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Gallus', 'Affiliation': ''}, {'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Raskob', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schellong', 'Affiliation': ''}, {'ForeName': 'Annelise', 'Initials': 'A', 'LastName': 'Segers', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1113572']
988,22254708,Physiological variables and subjective symptoms by 60 Hz magnetic field in EHS and non-EHS persons.,"Electromagnetic hypersensitivity (EHS) is a set of claims of adverse medical symptoms self attributed by exposure to electromagnetic field. In this study, we simultaneously investigated both physiological changes (heart rate, respiration rate, and heart rate variability) and subjective symptoms to determine the origin of EHS. Two volunteer groups (15 self-reported EHS and 16 non-EHS participants) were tested under both sham and real exposure to 12.5 μT magnetic fields at 60 Hz that lasted a half an hour. The magnetic field exposure did not have any effect on physiological variables or subjective symptoms in either group. We conclude that the subjective symptoms did not result from exposure to 12.5 μT magnetic field at 60 Hz.",2011,The magnetic field exposure did not have any effect on physiological variables or subjective symptoms in either group.,['Two volunteer groups (15 self-reported EHS and 16 non-EHS participants'],['Electromagnetic hypersensitivity (EHS'],"['physiological changes (heart rate, respiration rate, and heart rate variability) and subjective symptoms']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]","[{'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0354126,The magnetic field exposure did not have any effect on physiological variables or subjective symptoms in either group.,"[{'ForeName': 'Ki Chang', 'Initials': 'KC', 'LastName': 'Nam', 'Affiliation': 'Dept of Medical Engineering, Yonsei University College of Medicine, Seoul, Korea. chadol@yuhs.ac'}, {'ForeName': 'Jae Lim', 'Initials': 'JL', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Min Kyung', 'Initials': 'MK', 'LastName': 'Kwon', 'Affiliation': ''}, {'ForeName': 'Kyung Hwan', 'Initials': 'KH', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Deok Won', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6090544']
989,23157043,The efficacy of dinoprostone vaginal insert for active management of premature rupture of membranes at term: a randomized controlled trial.,"PURPOSE


To evaluate the efficacy and safety of the vaginal insertion of dinoprostone in terms of achieving cervical ripening, shortening the length of labor, and lowering the cesarean delivery rate for term pregnancies complicated with premature rupture of membranes.
METHODS


A prospective, randomized, controlled trial enrolled 100 women with term pregnancies complicated with premature rupture of membranes. Each had a normal non stress test, unscarred uterus, a singleton pregnancy with cephalic presentation, and a Bishop score of less than 4. Patients were randomized to receive a 10 mg dinoprostone vaginal insert single dose or no medication. After cervical ripening, oxytocin induction was performed during labor for both the study and control group. Cervical ripening in the 12th hour, total delivery time and delivery mode were compared between the two groups.
RESULTS


More often cervical ripening was obtained in the study group women who used dinoprostone vaginal inserts compared to the control group (p: 0.001). Latent phase of labor and total delivery time was shorter in the study group women than the control group (p: 0.022 and p: 0.026). There was no difference in terms of delivery mode and indication of section between study and control groups.
CONCLUSION


The use of dinoprostone vaginal inserts in patients with term pregnancy of premature rupture of membranes reduced both the latent phase of labor and total delivery time without increasing the rate of cesarean section.",2012,Latent phase of labor and total delivery time was shorter in the study group women than the control group (p: 0.022 and p: 0.026).,"['100 women with term pregnancies complicated with premature rupture of membranes', 'patients with term pregnancy of premature rupture of membranes', 'premature rupture of membranes at term', 'term pregnancies complicated with premature rupture of membranes']","['dinoprostone vaginal insert single dose or no medication', 'dinoprostone vaginal insert', 'dinoprostone vaginal inserts', 'dinoprostone']","['total delivery time and delivery mode', 'delivery mode and indication of section', 'cervical ripening', 'Cervical ripening', 'efficacy and safety', 'normal non stress test, unscarred uterus, a singleton pregnancy with cephalic presentation', 'Latent phase of labor and total delivery time', 'rate of cesarean section', 'latent phase of labor and total delivery time']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy (finding)'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C1719963', 'cui_str': 'Conventional release vaginal insert'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0600454', 'cui_str': 'Ripenings, Cervical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2979973'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]",100.0,0.0655686,Latent phase of labor and total delivery time was shorter in the study group women than the control group (p: 0.022 and p: 0.026).,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bezircioglu', 'Affiliation': 'Izmir Ataturk Training and Research Hospital, 1st Department of Gynecology and Obstetrics, Izmir, Turkey. drincimbezircioglu@yahoo.com'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Akin', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baloglu', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bicer', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
990,32493206,"Efficacy, tolerability, and safety of erenumab for the preventive treatment of persistent post-traumatic headache attributed to mild traumatic brain injury: an open-label study.","BACKGROUND


Calcitonin gene-related peptide (CGRP) has recently been implicated in the pathogenesis of post-traumatic headache (PTH), which raises the prospect for therapeutic use of monoclonal antibodies targeting CGRP or its receptor. Therefore, we decided to assess the efficacy, tolerability, and safety of erenumab for prevention of persistent PTH attributed to mild traumatic brain injury.
METHODS


A single-center, non-randomized, single-arm, open-label study of erenumab for adults aged 18-65 years with persistent PTH. Patients were assigned to receive 140-mg erenumab monthly by two subcutaneous 1-mL injections, given every 4 weeks for 12 weeks. The primary outcome measure was the mean change in number of monthly headache days of moderate to severe intensity from baseline (4-week pretreatment period) to week 9 through 12. Tolerability and safety endpoints were adverse events (i.e. number and type).
RESULTS


Eighty-nine of 100 patients completed the open-label trial. At baseline, the mean monthly number of headache days of moderate to severe intensity was 15.7. By week 9 through 12, the number was reduced by 2.8 days. The most common adverse events were constipation (n = 30) and injection-site reactions (n = 15). Of 100 patients who received at least one dose of erenumab, two patients discontinued the treatment regimen due to adverse events.
CONCLUSIONS


Among patients with persistent PTH, erenumab resulted in a lower frequency of moderate to severe headache days in this 12-week open-label trial. In addition, erenumab was well-tolerated as discontinuations due to adverse events were low. Placebo-controlled randomized clinical trials are needed to adequately evaluate the efficacy and safety of erenumab in patients with persistent PTH.
TRIAL REGISTRATION


ClinicalTrials.Gov, NCT03974360. Registered on April 17, 2019 - Retrospectively registered.",2020,The most common adverse events were constipation (n = 30) and injection-site reactions (n = 15).,"['adults aged 18-65\u2009years with persistent PTH', 'Eighty-nine of 100 patients completed the open-label trial', 'persistent post-traumatic headache attributed to mild traumatic brain injury', 'patients with\xa0persistent PTH']","['Calcitonin gene-related peptide (CGRP', 'erenumab', 'Placebo']","['Efficacy, tolerability, and safety', 'efficacy, tolerability, and safety', 'Tolerability and safety endpoints were adverse events (i.e. number and type', 'mean change in number of monthly headache days of moderate to severe intensity', 'efficacy and safety', 'mean monthly number of headache days of moderate to severe intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0032816', 'cui_str': 'Posttraumatic headache'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.205377,The most common adverse events were constipation (n = 30) and injection-site reactions (n = 15).,"[{'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Afrim', 'Initials': 'A', 'LastName': 'Iljazi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Haidar Muhsen', 'Initials': 'HM', 'LastName': 'Al-Khazali', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Anna Kristina', 'Initials': 'AK', 'LastName': 'Eigenbrodt', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Eigil Lindekilde', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Amalie Middelboe', 'Initials': 'AM', 'LastName': 'Andersen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Kevin John', 'Initials': 'KJ', 'LastName': 'Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Karoline Bendix', 'Initials': 'KB', 'LastName': 'Bräuner', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mørch-Jessen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Basit', 'Initials': 'B', 'LastName': 'Chaudhry', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Antic', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Casper Emil', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Faisal Mohammad', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark.'}, {'ForeName': 'Henrik Winther', 'Initials': 'HW', 'LastName': 'Schytz', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Valdemar Hansens Vej 5, DK-2600, Glostrup, Denmark. henrik.winther.schytz.01@regionh.dk.'}]",The journal of headache and pain,['10.1186/s10194-020-01136-z']
991,22268268,Speculum retention during embryo transfer does not improve pregnancy rates following embryo transfer--a randomized study.,"PURPOSE


To corroborate or refute two previous studies that suggested that a technique using prolonged speculum retention may improve pregnancy rates per embryo transfer.
METHODS


Women undergoing day 3 embryo transfer were randomly assigned to the conventional transfer technique vs the speculum retention technique. The speculum retention technique involves following the embryo transfer not to withdraw the speculum but to loosen the screw in order to exert gentle pressure on the portiovaginalis of the cervix and leave it in for seven minutes.
RESULTS


Clinical and viable pregnancy rates following the standard technique were 48.9% and 44.4%, respectively, vs 43.8% and 37.5% with the speculum retention technique. The implantation rates were also similar - 37.6% vs 37.5%.
CONCLUSIONS


This study was unable to corroborate the benefit of speculum retention in order to improve pregnancy rates per transfer.",2011,"RESULTS


Clinical and viable pregnancy rates following the standard technique were 48.9% and 44.4%, respectively, vs 43.8% and 37.5% with the speculum retention technique.",['Women undergoing day 3 embryo transfer'],['conventional transfer technique vs the speculum retention technique'],"['implantation rates', 'pregnancy rates', 'viable pregnancy rates', 'pregnancy rates per transfer']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0404843', 'cui_str': 'Viable pregnancy (finding)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.0977335,"RESULTS


Clinical and viable pregnancy rates following the standard technique were 48.9% and 44.4%, respectively, vs 43.8% and 37.5% with the speculum retention technique.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Amui', 'Affiliation': 'The University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School at Camden Cooper Hospital/University Medical Center, Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology & Infertility, Camden, NJ, USA.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Check', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brasile', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
992,22254265,Modeling the effects of bivalirudin in cardiac surgical patients.,"Bivalirudin is direct thrombin inhibitor used in patients with heparin-induced thrombocytopenia. A pharmacokinetic and--dynamic model that predicts the partial thromboplastin time (PTT) based on the past infusion rates of bivalirudin following dose adjustment would be useful to guide optimal therapy. In this retrospective study we randomized 132 patients to a derivation and a validation cohort, and tested two models. The first model is a single-state linear model; the other incorporates a non-linear element to account for renal elimination of bivalirudin. Both models predicted PTT changes equally well with root-mean squared errors of 15 to 16 seconds (Pearson correlation coefficients for both were 0.67). Intra- and inter-individual variability of response to bivalirudin was significant. Although a high percentage of patients had moderate to severe renal dysfunction at one point during the bivalirudin infusion, the non-linear model that incorporates variable renal clearance of drug did not perform better than the linear model. This finding persisted even in the subgroup analysis of patients with moderate and low estimated glomerular filtration rates.",2011,Both models predicted PTT changes equally well with root-mean squared errors of 15 to 16 seconds (Pearson correlation coefficients for both were 0.67).,"['cardiac surgical patients', '132 patients to a derivation and a validation cohort, and tested two models', 'patients with heparin-induced thrombocytopenia']","['bivalirudin', 'Bivalirudin']","['partial thromboplastin time (PTT', 'severe renal dysfunction', 'glomerular filtration rates']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia (disorder)'}]","[{'cui': 'C0168273', 'cui_str': 'bivalirudin'}]","[{'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]",132.0,0.020922,Both models predicted PTT changes equally well with root-mean squared errors of 15 to 16 seconds (Pearson correlation coefficients for both were 0.67).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Edrich', 'Affiliation': 'Department of Anesthesia, Perioperative and Pain Medicine, Brigham and Women’s Hospital, Boston, MA 02115, USA. tedrich@partners.org'}, {'ForeName': 'Gyorgy', 'Initials': 'G', 'LastName': 'Frendl', 'Affiliation': ''}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Rawn', 'Affiliation': ''}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paschalidis', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6089911']
993,22254399,Improving postural stability via computational modeling approach to deep brain stimulation programming.,"Bilateral subthalamic (STN) deep brain stimulation (DBS) is generally effective in improving the cardinal motor signs of advanced Parkinson's disease (PD). However, in many cases postural instability is refractory to STN DBS. The goal of this project was to determine if postural instability could be improved with STN DBS by avoiding current spread to the non-motor territories of the STN. Stimulation parameters that maximized activation of a theoretically defined target region were determined via patient-specific computer models created in Cicerone. Postural stability was assessed under three conditions: Off DBS, Clinical DBS, and Model DBS. Clinical settings were the patients' DBS settings determined via traditional clinical practice and were considered optimized and stable for at least 6 months prior to study enrollment. Blinded and randomized evaluations were performed in five patients. Postural sway was significantly less during Model DBS compared to Clinical DBS. These results support the hypothesis that minimizing spread of current to non-motor territories of the STN can improve PD related instability with DBS.",2011,Postural sway was significantly less during Model DBS compared to Clinical DBS.,[],['Bilateral subthalamic (STN) deep brain stimulation (DBS'],"['Postural stability', 'Postural sway']",[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}]",5.0,0.0348861,Postural sway was significantly less during Model DBS compared to Clinical DBS.,"[{'ForeName': 'Cameron C', 'Initials': 'CC', 'LastName': 'McIntyre', 'Affiliation': ''}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Richardson', 'Affiliation': ''}, {'ForeName': 'Anneke M', 'Initials': 'AM', 'LastName': 'Frankemolle', 'Affiliation': ''}, {'ForeName': 'Georgeta', 'Initials': 'G', 'LastName': 'Varga', 'Affiliation': ''}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Noecker', 'Affiliation': ''}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Alberts', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6090151']
994,22254485,Effectiveness of interval training compared with endurance training in cardiac rehabilitation.,"Anaerobic endurance training (AET) can improve sympathomimetic hyperactivity, and anaerobic interval training (AIT) is recommended for patients who cannot exercise due to exertional breathlessness and leg fatigue. However, the difference in sympathetic nerve activation (SNA) and parasympathetic nerve activation (PNA) during AIT and AET is unclear. The aim of this study is to investigate the differences between endurance and interval trainings. We studied three patients (63-73 years) assigned to AIT which exercise/pause phase is 60/120 seconds (AIT120) and AET of 10 minutes duration. Systolic blood pressure, heart rate (HR), and rate pressure product (as an index of SNA) and oxygen uptake, tidal volume, respiratory rate, and minute ventilation were measured. As a result, these parameters in AET were increased compared with those of AIT120 among the subjects. While, high frequency component of frequency distribution in HR (HF) in AET was decrease compared with that in AIT120 among subject. We concluded that AIT inhibited SNA more effectively compared with AET and AIT may be safe for cardiac rehabilitation.",2011,"While, high frequency component of frequency distribution in HR (HF) in AET was decrease compared with that in AIT120 among subject.","['patients who cannot exercise due to exertional breathlessness and leg fatigue', 'cardiac rehabilitation']","['anaerobic interval training (AIT', 'interval training', 'Anaerobic endurance training (AET', 'endurance training', 'AET and AIT']","['Systolic blood pressure, heart rate (HR), and rate pressure product (as an index of SNA) and oxygen uptake, tidal volume, respiratory rate, and minute ventilation', 'sympathetic nerve activation (SNA) and parasympathetic nerve activation (PNA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0629582', 'cui_str': 'AETS'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0459522', 'cui_str': 'Parasympathetic nerve'}]",3.0,0.0307226,"While, high frequency component of frequency distribution in HR (HF) in AET was decrease compared with that in AIT120 among subject.","[{'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Hanada', 'Affiliation': 'Department of Medical System Engineering, Faculty of Engineering, Chiba University, 1-33 Yayoi-cho, Inage-ku, Chiba 263-8522, Japan. hands_54@graduate.chiba-u.jp'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Sekine', 'Affiliation': ''}, {'ForeName': 'Toshiyo', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': ''}, {'ForeName': 'Tomokazu', 'Initials': 'T', 'LastName': 'Shinchi', 'Affiliation': ''}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Fujimoto', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6090236']
995,31345639,"Long-term immunogenicity of measles, mumps and rubella-containing vaccines in healthy young children: A 10-year follow-up.","Measles and mumps outbreaks still occur in countries that have successfully implemented universal routine immunization programs. Measles outbreaks are mostly associated to absent or incomplete vaccination, whereas for mumps outbreaks the combined effects of waning of immunity and circulating new strains are incriminated. It is therefore increasingly useful to characterize the long-lasting immunity induced by measles-, mumps, and rubella (MMR)-containing vaccines. In this 10-year study, 1887 healthy children aged 12-22 months, randomized to receive 1 or 2 doses of MMR-containing vaccines (Priorix or Priorix-Tetra; GSK), were included in an antibody persistence analysis. A total of 364 children in the 1-dose group received a second dose out of study according to their local vaccination schedule between Years 4 and 10 post-dose 1, and were included in a separate post-hoc analysis to evaluate the effect of the second dose when given later. Anti-measles, -mumps and -rubella antibody titers were measured by commercial ELISA kits (Enzygnost, Siemens) after each vaccine dose and at Years 1, 2, 4, 6, 8 and 10 post-vaccination. Antibodies against measles and rubella declined moderately after vaccination but remained well above the seropositivity threshold after 10 years. The anti-measles antibody titers elicited by Priorix-Tetra remained about 2-fold higher throughout the study as compared with Priorix. A second dose of MMR vaccine later in life had a minor and transient effect on anti-measles and anti-rubella waning titers. In contrast, anti-mumps antibody levels remained relatively stable over the 10-year follow-up and a second dose of MMR vaccine, given anytime over the 10-year period, had a boosting effect on anti-mumps antibody titers and seropositivity rates. In conclusion, 1 or 2 doses of MMR-containing vaccines given to children in their second year of life induced antibody responses against measles, mumps and rubella viruses that persisted at least up to 10 years post-vaccination. Clinical trial registration number: NCT00226499.",2019,A second dose of MMR vaccine later in life had a minor and transient effect on anti-measles and anti-rubella waning titers.,"['364 children in the 1-dose group', '1887 healthy children aged 12-22\u202fmonths', 'healthy young children']","['MMR vaccine', 'MMR-containing vaccines', 'MMR-containing vaccines (Priorix or Priorix-Tetra; GSK', 'measles, mumps and rubella-containing vaccines']","['Anti-measles, -mumps and -rubella antibody titers', 'Antibodies against measles and rubella']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0065828', 'cui_str': 'MMR Vaccine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0732248', 'cui_str': 'Priorix'}, {'cui': 'C1010292', 'cui_str': 'Tetras'}, {'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0026780', 'cui_str': 'Parotitis, Epidemic'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}]","[{'cui': 'C0025007', 'cui_str': 'Rubeola'}, {'cui': 'C0026780', 'cui_str': 'Parotitis, Epidemic'}, {'cui': 'C0474654', 'cui_str': 'Rubella antibody titer measurement'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0035920', 'cui_str': 'Measles, German'}]",364.0,0.0941916,A second dose of MMR vaccine later in life had a minor and transient effect on anti-measles and anti-rubella waning titers.,"[{'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Carryn', 'Affiliation': 'R&D Center Belgium, GSK, Wavre, Belgium. Electronic address: stephane.x.carryn@gsk.com.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Feyssaguet', 'Affiliation': 'Clinical Laboratory Sciences, GSK, Rixensart, Belgium. Electronic address: muriel.m.feyssaguet@gsk.com.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Povey', 'Affiliation': 'Biostatistics, GSK, Wavre, Belgium. Electronic address: michael.x.povey@gsk.com.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Di Paolo', 'Affiliation': 'Clinical Laboratory Sciences, GSK, Rixensart, Belgium. Electronic address: emmanuel.di-paolo@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2019.07.049']
996,31540869,Comparison of postoperative morbidity between conventional cold dissection and bipolar electrocautery tonsillectomy: which technique is better?,"INTRODUCTION


Tonsillectomy is one of the most common surgeries in the head and neck worldwide. This operation is carried out by different methods, the most frequent of which are the cold dissection and bipolar electrocautery techniques.
OBJECTIVE


This study was conducted to assess and compare postoperative morbidity between cold dissection and bipolar electrocautery.
METHODS


This prospective randomized clinical trial was performed on 534 patients who underwent tonsillectomy in Vali-e-Asr Hospital of Birjand, east of Iran from October, 2013 to October, 2015. The patients were systematically selected for cold dissection technique or bipolar electrocautery technique groups. Time of surgery, amount of intraoperative blood loss, postoperative hemorrhage, the intensity of local pain 4 and 24hours after operation and nausea and/or vomiting were recorded and compared in the two groups to decide which technique is better. The data were analyzed in SPSS software (ver-22). The p-value less than 0.5 was considered significant.
RESULTS


In this study, 51.7% of the cold dissection technique patients and 50.6% of the bipolar electrocautery technique participants were male. Compared to the cold dissection technique, the average intraoperative blood loss was significantly lower (p<0.001) in the bipolar electrocautery technique group, while the intensity of local pain 4 and 24hours after the operation was significantly higher (p<0.001). Other variables showed no significant differences between the two groups.
CONCLUSION


Based on the findings of the present investigation, the bipolar electrocautery technique is suggested for tonsillectomy in children, while the cold dissection technique is preferred for adult patients.",2020,"Compared to the cold dissection technique, the average intraoperative blood loss was significantly lower (p<0.001) in the bipolar electrocautery technique group, while the intensity of local pain 4 and 24h after the operation was significantly higher (p<0.001).","['534 patients who underwent tonsillectomy in Vali-e-Asr Hospital of Birjand, east of Iran from October, 2013 to October, 2015']","['cold dissection technique', 'cold dissection and bipolar electrocautery', 'conventional cold dissection and bipolar electrocautery tonsillectomy', 'cold dissection technique or bipolar electrocautery technique groups']","['intensity of local pain', 'postoperative morbidity', 'average intraoperative blood loss', 'Time of surgery, amount of intraoperative blood loss, postoperative hemorrhage, the intensity of local pain 4 and 24h after operation and nausea and/or vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",534.0,0.0446586,"Compared to the cold dissection technique, the average intraoperative blood loss was significantly lower (p<0.001) in the bipolar electrocautery technique group, while the intensity of local pain 4 and 24h after the operation was significantly higher (p<0.001).","[{'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mofatteh', 'Affiliation': 'Birjand University of Medical Sciences, Faculty of Medicine, Department of Ears, Nose and Throat, Birjand, Iran.'}, {'ForeName': 'Forod', 'Initials': 'F', 'LastName': 'Salehi', 'Affiliation': 'Birjand University of Medical Sciences, Faculty of Medicine, Department of Cardiology, Birjand, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Birjand University of Medical Sciences, Cellular and Molecular Research Center, Birjand, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Hassanzadeh-Taheri', 'Affiliation': 'Birjand University of Medical Sciences, Faculty of Medicine, Birjand, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Sharifzadeh', 'Affiliation': 'Birjand University of Medical Sciences, Faculty of Health, Birjand, Iran.'}, {'ForeName': 'Mohammadmehdi', 'Initials': 'M', 'LastName': 'Hassanzadeh-Taheri', 'Affiliation': 'Birjand University of Medical Sciences, Faculty of Medicine, Department of Anatomy, Birjand, Iran. Electronic address: mmhtahery35@gmail.com.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2018.12.013']
997,22256222,Independent component analysis of resting brain activity reveals transient modulation of local cortical processing by transcranial direct current stimulation.,"Neuroplasticity induced by transcranial direct current stimulation (tDCS) contributes to motor learning although the underlying mechanisms are incompletely understood. Here, we investigated the effects of tDCS on resting brain dynamics recorded by whole-head magnetoencephalography (MEG) pre- and up to 35 minutes post-tDCS or sham over the left primary motor cortex (M1) in healthy adults. Owing to superior temporal and spatial resolution of MEG, we sought to apply a robust, blind and data-driven analytic approach such as independent component analysis (ICA) and statistical clustering to these data to investigate potential neuroplastic effects of tDCS during resting state conditions. We found decreased alpha and increased gamma band power that outlasted the real tDCS stimulation period in a fronto-parietal motor network relative to sham. However, this method could not find differences between anodal and cathodal polarities of tDCS. These results suggest that tDCS over M1 modulates resting brain dynamics in a fronto-parietal motor network (that includes the stimulated location), indicative of within-network enhanced localized cortical processing.",2011,and up to 35 minutes post-tDCS or sham over the left primary motor cortex (M1) in healthy adults.,['healthy adults'],"['tDCS or sham over the left primary motor cortex (M1', 'whole-head magnetoencephalography (MEG) pre', 'tDCS', 'transcranial direct current stimulation (tDCS']",['resting brain dynamics'],"[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",,0.0369717,and up to 35 minutes post-tDCS or sham over the left primary motor cortex (M1) in healthy adults.,"[{'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Graduate Program in Neuroscience and Cognitive Science, University of Maryland, College Park, MD 20742, USA. venkatakrishna@ninds.nih.gov'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Contreras-Vidal', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sandrini', 'Affiliation': ''}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Cohen', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6091998']
998,22256223,Relationship between pulse number of rTMS and inter reversal time of perceptual reversal.,"The aim of this study is to investigate the stimulus parameter which affects the repetitive Transcranial Magnetic Stimulation (rTMS) effect. It is said that the condition under 1Hz rTMS induces the inhibition effect. On the other hand, the condition over 1 Hz rTMS induces the facilitation effect. However the number of pulses of rTMS is also important factor. In this study, we focused on the number of pulses. We used the cognitive task of perceptual reversal and compared the rTMS effects of different condition under 1 Hz which is the inhibition condition. It has been known that the right superior parietal lobule (SPL) has a role in perceptual reversal. We applied rTMS over the SPL and measured the inter-reversal time (IRT) of perceptual reversal. The results showed that when 0.25 Hz 60 pulses, 0.5 Hz 60 pulses and 1 Hz 60 pulses of rTMS was applied over the right SPL, the IRT was significantly smaller. On the other hand, when 1 Hz 240 pulses of rTMS was applied over the right SPL, the IRT was significantly longer. When 0.25 Hz 12 0 pulses, 0.5 Hz 120 pulses and 1Hz 120 pulses of rTMS was applied over the right SPL, there were no significant differences. Furthermore, to investigate the rTMS effects, when rTMS are applied over the motor area, we measured the motor evoked potential (MEP). The more pulses of rTMS was applied, the smaller the amplitude of MEP became. From these results, it was found that the IRT of perceptual reversal and the amplitude of MEP primarily affected by the number of pulses of rTMS.",2011,"The more pulses of rTMS was applied, the smaller the amplitude of MEP became.",[],"['rTMS', 'repetitive Transcranial Magnetic Stimulation (rTMS']","['pulse number of rTMS and inter reversal time of perceptual reversal', 'motor evoked potential (MEP']",[],"[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}]",,0.022295,"The more pulses of rTMS was applied, the smaller the amplitude of MEP became.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nojima', 'Affiliation': 'Graduate School of Systems Life Sciences, Kyushu University, 744 Motooka Nishi-ku, Fukuoka 819-0395, Japan. nojima@bie.is.kyusyu-u.ac.jp'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ge', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Katayama', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Iramina', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2011.6091999']
999,21995159,Two-year experience of obstetric cholestasis: outcome and management.,"PURPOSE


Our aim was to evaluate the management and outcome of obstetric cholestasis in our perinatology unit.
METHODS


We analyzed 44 pregnant women complicated by cholestasis. Data were collected retrospectively. Details of patient demographics and outcomes of pregnancy were recorded. Patients were randomized due to their decision to take ursodeoxycholic acid (UDCA) therapy or not.
RESULTS


Forty-four women of age 28.09 +/- 4.6 years delivered 45 newborns. The mean gestational age at diagnosis of obstetric cholestasis was 32.36 +/- 3.75 weeks. The mean delivery time was 38.25 +/- 1.5 weeks. Spontaneous premature delivery occurred in five (11.4%) of the patients. No stillbirths were observed. Serum transaminases decreased significantly in 26 of the patients who were treated with oral UDCA therapy. Twelve (27.2%) babies were admitted to the neonatal intensive care unit (NICU). Out of 12 mothers whose babies were admitted to NICU, nine patients had not received UDCA (p = 0.07).
CONCLUSION


UDCA is effective in lowering transaminases.",2011,No stillbirths were observed.,"['Twelve (27.2%) babies were admitted to the neonatal intensive care unit (NICU', 'Forty-four women of age 28.09 ', '44 pregnant women complicated by cholestasis']","['UDCA', 'ursodeoxycholic acid (UDCA) therapy or not']","['mean delivery time', 'Serum transaminases', 'mean gestational age at diagnosis of obstetric cholestasis', 'Spontaneous premature delivery']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0008370', 'cui_str': 'Bile Duct Obstruction'}]","[{'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0268318', 'cui_str': 'Intrahepatic Cholestasis of Pregnancy'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}]",44.0,0.0350731,No stillbirths were observed.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Deveer', 'Affiliation': 'Dr. Zekai Tahir Burak Women Health Research and Education Hospital, Ankara, Turkey. deveer3@hotmail.com'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Engin-Ustun', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Celen', 'Affiliation': ''}, {'ForeName': 'O G', 'Initials': 'OG', 'LastName': 'Eryilmaz', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tonguç', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mollamahmutoğlu', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Oksuzoglu', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Danisman', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1000,21995153,Transdermal estrogen therapy effects on fibrinogen levels in women with a past history of venous thromboembolism: a pilot study.,"OBJECTIVE


To evaluate thromboelastographic parameters and fibrinogen levels in women treated with transdermal 17beta estradiol.
METHODS


29 menopausal women with a history of venous thromboembolic disease were included. Nine patients composed the treatment (HT) group and 20 the control group. Coagulation was assessed by thromboelastography in samples of whole blood and platelet-poor plasma (PPP). The following thromboelastographic variables were measured: time for initial coagulation (R), blood clotting speed (K and the alpha angle), clot tensile strength (MA and G), global index of coagulation (CI) and fibrinolysis (LY30) and fibrinogen levels.
RESULTS


There were no differences in the other parameters comparing both groups. Fibrinogen levels showed a 13.77 +/- 19.94% reduction in the HT group and a 5.51 +/- 8.09% increase in the control group after 6 months.
CONCLUSIONS


Our data suggested that transdermal estrogen may not increase blood coagulability, but that it reduces fibrinogen levels in HT women.",2011,There were no differences in the other parameters comparing both groups.,"['29 menopausal women with a history of venous thromboembolic disease were included', 'HT women', 'women with a past history of venous thromboembolism', 'women treated with transdermal 17beta estradiol']",['Transdermal estrogen therapy'],"['Coagulation', 'blood coagulability', 'Fibrinogen levels', 'time for initial coagulation (R), blood clotting speed (K and the alpha angle), clot tensile strength (MA and G), global index of coagulation (CI) and fibrinolysis (LY30) and fibrinogen levels', 'thromboelastographic parameters and fibrinogen levels', 'fibrinogen levels']","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1997787', 'cui_str': 'History of venous thromboembolic disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0279494'}]","[{'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen measurement'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0005778', 'cui_str': 'Blood Clotting'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C1540845', 'cui_str': 'Muscle tensile strength, function (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",29.0,0.0785057,There were no differences in the other parameters comparing both groups.,"[{'ForeName': 'P F R', 'Initials': 'PF', 'LastName': 'Margarido', 'Affiliation': 'Department of Obstetrics and Gynecology, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'V R', 'Initials': 'VR', 'LastName': 'Bagnoli', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Maggio da Fonseca', 'Affiliation': ''}, {'ForeName': 'G A R', 'Initials': 'GA', 'LastName': 'Maciel', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Soares', 'Affiliation': ''}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': ""D'Amico"", 'Affiliation': ''}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Baracat', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1001,21995156,A new approach in the first-line treatment of bacterial and mycotic vulvovaginitis with topical lipohydroperoxides and glycyrrhetic acid: a comparative study.,"UNLABELLED


PURPOSE OF INVESTIGATIONS: The aim of this randomized controlled trial was to evaluate efficacy and tolerability of a new association of lipohydroperoxides and glycyrrhetic acid on topical treatment of bacterial and mycotic vulvovaginitis.
METHODS


One hundred consecutive patients with bacterial or mycotic vulvovaginitis were randomly assigned to a study group treated with vaginal lipohydroperoxides and a derivative of glycyrrhetic acid for three days (n = 50), and a control group using vaginal antibacterial metronidazole (500 mg) or antimycotic econazole (150 mg) for six days (n = 50).
RESULTS


A clinical and microbiological response was achieved in 80.4% and 88.9% in investigational and control group, respectively (p > 0.05). Compared to traditional antimicrobial drugs, the effect appears to be faster and safer, even if not significantly. The 6-month recurrence rate was 7.7% and 5.6% in the investigational and control group, respectively.
CONCLUSION


Topical medication based on lipohydroperoxides and glycyrrhetic acid showed a clinical and microbiological efficacy in the first-line treatment of bacterial and mycotic vulvovaginitis, comparable to conventional drugs.",2011,"The 6-month recurrence rate was 7.7% and 5.6% in the investigational and control group, respectively.
",['One hundred consecutive patients with bacterial or mycotic vulvovaginitis'],"['control group using vaginal antibacterial metronidazole (500 mg) or antimycotic econazole', 'topical lipohydroperoxides and glycyrrhetic acid', 'vaginal lipohydroperoxides and a derivative of glycyrrhetic acid', 'lipohydroperoxides and glycyrrhetic acid']","['efficacy and tolerability', 'microbiological response', '6-month recurrence rate']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042998', 'cui_str': 'Vulvovaginitis'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0017986', 'cui_str': 'enoxolone'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",100.0,0.0402441,"The 6-month recurrence rate was 7.7% and 5.6% in the investigational and control group, respectively.
","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mainini', 'Affiliation': 'Fondazione IRCCS SDN, Napoli, Italy. giampaolomainini@libero.it'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rotondi', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Scaffa', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1002,21833698,Puerarin alleviates burn-related procedural pain mediated by P2X(3) receptors.,"Pain is a major problem after burns. Procedural pain evoked by burn dressing changes is common in patients, and its management is a critical part of treatment in acute burn injuries. Burn pain is very likely the most difficult form of acute pain to treat. ATP contributes to inflammation, and ATP is implicated in peripheral pain signaling via actions upon P2X(3) receptors. Puerarin is extracted from a traditional Chinese medicine and may act on P2X(3) receptor mechanisms. The Visual Analogue Scale (VAS) has been shown to be a sensitive indicator of pain intensity and treatment effects. Peripheral blood mononuclear cells (PBMCs) are involved in nociception or pain after burn injury. Burn patients were randomly divided into normal saline (NS) group (salt solution is saline) and puerarin-treated group and pain (Visual Analogue Scale scores) and inflammation (PBMCs) measured. Burn pain produces a stress response, so blood glucose, insulin, and cortisol levels in burn patients were determined. Furthermore, the expression of P2X(3) protein and mRNA in PBMCs was detected. The VAS scores in the puerarin-treated group were lower than those in NS group. The blood glucose, insulin, and cortisol levels in the puerarin-treated group at post-dressing changes were significantly decreased in comparison with those in NS group. The expression levels of P2X(3) protein and mRNA in PBMCs of burn patients in NS group were significantly increased in comparison with those in the puerarin-treated group. Puerarin can antagonize inflammatory factors (such as ATP) and decrease the upregulated expressions of P2X(3) protein and mRNA in PBMCs after burns to decrease VAS. Thus, puerarin had an analgesic effect on procedural pain in dressing changes of burn patients related to P2X(3) receptors.",2011,The expression levels of P2X(3) protein and mRNA in PBMCs of burn patients in NS group were significantly increased in comparison with those in the puerarin-treated group.,['Burn patients'],['normal saline (NS) group (salt solution is saline) and puerarin'],"['expression of P2X(3) protein and mRNA in PBMCs', 'Peripheral blood mononuclear cells (PBMCs', 'Visual Analogue Scale (VAS', 'procedural pain', 'Pain', 'expression levels of P2X(3) protein and mRNA in PBMCs', 'pain (Visual Analogue Scale scores) and inflammation (PBMCs', 'VAS scores', 'blood glucose, insulin, and cortisol levels']","[{'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3653289', 'cui_str': 'Salt irrigating solutions'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0072591', 'cui_str': 'kakonein'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",,0.0303297,The expression levels of P2X(3) protein and mRNA in PBMCs of burn patients in NS group were significantly increased in comparison with those in the puerarin-treated group.,"[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Physiology, Medical College of Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Changshui', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Guilin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Shuangmei', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Jinyan', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Shangdong', 'Initials': 'S', 'LastName': 'Liang', 'Affiliation': ''}]",Purinergic signalling,['10.1007/s11302-011-9248-5']
1003,32115392,Clinical pharmacists in diabetes management: What do minority patients with uncontrolled diabetes have to say?,"OBJECTIVE


Clinical pharmacist support for patients with type 2 diabetes mellitus (T2DM) can optimize patient outcomes and medication adherence. However, there is limited understanding of what pharmacist roles patients perceive as most helpful in T2DM management interventions. This study describes experiences of minority patients with uncontrolled T2DM in terms of perceived pharmacist helpfulness and specific roles found to be most helpful within diabetes management.
DESIGN


A secondary analysis of a 2-year randomized, crossover trial was conducted.
SETTING AND PARTICIPANTS


This study included 244 African American and Hispanic adults with uncontrolled T2DM who received clinical pharmacist support within a team-based model.
OUTCOME MEASURES


The patients completed a mixed-methods survey regarding their experience with the intervention that included a general helpfulness rating on a 10-point unipolar Likert scale and described the support qualitatively, including their perception of the pharmacist roles. Thematic analysis guided coding of the responses.
RESULTS


One hundred forty-seven (60%) patients completed the survey and had at least 1 encounter with a clinical pharmacist. Of these, 108 (74%) were African American, 39 (27%) were Hispanic, and 101 (69%) were women. The median rating of clinical pharmacist helpfulness was 10 (very helpful). Only 10 (7%) participants rated pharmacist helpfulness as 1 (not at all helpful). ""Medication education and management"" was the most frequently perceived supportive role of the clinical pharmacists, followed by ""non-medication-related patient education,"" ""social support,"" and ""care coordination."" Miscommunication related to scheduling was the most common reason cited for not meeting with the clinical pharmacist.
CONCLUSION


This sample of minority patients with uncontrolled T2DM recognized many roles outlined within the American Pharmacists Association Medication Therapy Management framework. Patient experiences with clinical pharmacist T2DM support are crucial for developing effective programs, maximizing patient engagement, satisfying patient needs, and ensuring that a program's intended purpose aligns with the patient perspective.",2020,"Medication education and management"" was the most frequently perceived supportive role of the clinical pharmacists, followed by ""non-medication-related patient education,"" ""social support,"" and ""care coordination.""","['minority patients with uncontrolled T2DM', '108 (74%) were African American, 39 (27%) were Hispanic, and 101 (69%) were women', 'minority patients with uncontrolled diabetes', '244 African American and Hispanic adults with uncontrolled T2DM who received clinical pharmacist support within a team-based model', 'One hundred forty-seven (60%) patients completed the survey and had at least 1 encounter with a clinical pharmacist', 'patients with type 2 diabetes mellitus (T2DM']",[],"['pharmacist helpfulness', 'median rating of clinical pharmacist helpfulness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}]",244.0,0.0432504,"Medication education and management"" was the most frequently perceived supportive role of the clinical pharmacists, followed by ""non-medication-related patient education,"" ""social support,"" and ""care coordination.""","[{'ForeName': 'Nadia A', 'Initials': 'NA', 'LastName': 'Nabulsi', 'Affiliation': ''}, {'ForeName': 'Connie H', 'Initials': 'CH', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Tilton', 'Affiliation': ''}, {'ForeName': 'Ben S', 'Initials': 'BS', 'LastName': 'Gerber', 'Affiliation': ''}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Sharp', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2020.01.024']
1004,21485725,Intravaginal misoprostol reduces intraoperative blood loss in minimally invasive myomectomy: a randomized clinical trial.,"PURPOSE OF INVESTIGATION


We performed a randomized clinical trial to estimate whether preoperative use of misoprostol may reduce intraoperative blood loss of patients treated by minimally invasive surgery (MIS), such as laparoscopic (LM) or laparoscopically assisted myomectomy (LAM).
METHODS


Sixty-seven menstruating patients with three or less myomas of a maximum diameter of 90 mm, scheduled for MIS, were randomly allocated to receive a preoperative single dose of intravaginal misoprostol or placebo. Sixty-four patients remained in the final analysis: 30 in the misoprostol (I) and 34 in the placebo group (II). Estimated blood loss (EBL), decline of postoperative hemoglobin (Hb) and side-effects of administered agent were the outcomes of main interest.
RESULTS


The EBL was significantly higher in the placebo versus misoprostol group (217 +/- 74 vs 126 +/- 41, respectively). Similarly, the decline of postoperative Hb was significantly higher in group II (1.6 +/- 0.43) compared to group I (1 +/- 0.33). The operative time was comparable in both groups, while the rate of side-effects was similar between groups.
CONCLUSION


The preoperative use of misoprostol in patients with uterine fibroids managed by minimally invasive surgery significantly reduces intraoperative blood loss. Misoprostol might be useful for the prevention of postoperative anemia in more extended minimal invasive interventions, such as myomectomy of large fibroids or laparoscopic hysterectomy.",2011,The preoperative use of misoprostol in patients with uterine fibroids managed by minimally invasive surgery significantly reduces intraoperative blood loss.,"['patients with uterine fibroids managed by', 'Sixty-seven menstruating patients with three or less myomas of a maximum diameter of 90 mm, scheduled for MIS', 'Sixty-four patients remained in the final analysis: 30 in the misoprostol (I) and 34 in the placebo group (II', 'minimally invasive myomectomy', 'patients treated by minimally invasive surgery (MIS']","['intravaginal misoprostol or placebo', 'Misoprostol', 'placebo', 'minimally invasive surgery', 'laparoscopic (LM) or laparoscopically assisted myomectomy (LAM', 'misoprostol', 'Intravaginal misoprostol']","['rate of side-effects', 'decline of postoperative Hb', 'EBL', 'operative time', 'Estimated blood loss (EBL), decline of postoperative hemoglobin (Hb) and side-effects', 'intraoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0195309', 'cui_str': 'Uterine Myomectomy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}]","[{'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0195309', 'cui_str': 'Uterine Myomectomy'}, {'cui': 'C0065041', 'cui_str': 'lipoarabinomannan'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",67.0,0.520604,The preoperative use of misoprostol in patients with uterine fibroids managed by minimally invasive surgery significantly reduces intraoperative blood loss.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kalogiannidis', 'Affiliation': 'IAKENTRO, Advanced Medical Center, Thessaloniki, Greece. kalogiannidis@mailbox.gr'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Xiromeritis', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Prapas', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Prapas', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1005,21793278,Exteriorized versus in-situ repair of the uterine incision at cesarean delivery: a randomized controlled trial.,"PURPOSE OF INVESTIGATION


To compare advantages and disadvantages of exteriorized and in situ repair techniques of uterine incision during cesarean section.
METHODS


A total of 338 patients delivered by cesarean section were included in the study. Patients were randomized according to the location of uterine incision repair; the uterus was exteriorized (n = 171) or not (in situ repair group) (n = 167) during cesarean section. Two groups were compared in terms of blood loss, operation time, temperature patterns, analgesic dosage, length of hospital stay, incidence of nausea and vomiting.
RESULTS


There was no significant difference in postoperative analgesic dosage, temperature patterns, drops in hemoglobin or hematocrit levels and in the incidence of postoperative nausea and vomiting between the two groups. Operation time and length of hospital stay were significantly shorter in the in situ repair group, when it was compared to those of which the uterus was exteriorized (30.64 +/- 8.65 vs 33.02 +/- 9.54 min., p = 0.011 and 2.23 +/- 0.49 vs 2.45 +/- 0.94 days, p = 0.045).
CONCLUSIONS


Exteriorized and in situ repair of uterine incisions have similar effects on blood loss, temperature patterns, postoperative analgesic dosage and the incidence of postoperative nausea and vomiting. Although both methods of uterine incision repair are valid options during surgery, cesarean sections took less time and length of hospital stay was shorter when uterine incision was repaired in situ.",2011,"There was no significant difference in postoperative analgesic dosage, temperature patterns, drops in hemoglobin or hematocrit levels and in the incidence of postoperative nausea and vomiting between the two groups.",['338 patients delivered by cesarean section were included in the study'],"['uterine incision repair', 'Exteriorized versus in-situ repair of the uterine incision']","['postoperative analgesic dosage, temperature patterns, drops in hemoglobin or hematocrit levels', 'postoperative nausea and vomiting', 'blood loss, temperature patterns, postoperative analgesic dosage and the incidence of postoperative nausea and vomiting', 'blood loss, operation time, temperature patterns, analgesic dosage, length of hospital stay, incidence of nausea and vomiting', 'time and length of hospital stay', 'Operation time and length of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0475403', 'cui_str': 'Exteriorized (qualifier value)'}, {'cui': 'C0444498', 'cui_str': 'In situ (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}]",338.0,0.107062,"There was no significant difference in postoperative analgesic dosage, temperature patterns, drops in hemoglobin or hematocrit levels and in the incidence of postoperative nausea and vomiting between the two groups.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ozbay', 'Affiliation': 'Department of Obstetrics and Gynecology, Government Hospital of Ahlat, Bitlis, Turkey. mdkorayozbay@yahoo.com'}]",Clinical and experimental obstetrics & gynecology,[]
1006,21793279,Total infusion of low molecular weight iron-dextran for treating postpartum anemia.,"AIM


135 puerperal women with iron deficiency anemia participated in our prospective randomized controlled trial in order to investigate alternative treatments to blood transfusion for anemia.
MATERIALS AND METHODS


The criteria for the diagnosis of anemia were Hb < 8 g/dl and ferritine < 10 microg/dl. Women were randomly separated in two groups, A and B. Women of group A (n = 109 women) received a total amount of 1000 mg low molecular weight (LMW) iron-dextran intravenously in two doses. Group B (n = 26) was the control group. They received orally 800 mg daily for 30 days of iron protein-succinylate. Three weeks later women of both groups underwent a full blood count analysis.
RESULTS


Hemoglobin and ferritin levels increased significantly in group A compared to group B (p < 0.0001). No adverse side-effects due to the treatment were noted in either group.
CONCLUSION


It seems that total iron-dextran infusion is a safe and rapid therapy of iron-deficiency postpartum anemia increases the Hb level more rapidly than oral ferrous sulfate, and it also appears to replenish iron stores more rapidly.",2011,levels increased significantly in group A compared to group B (p < 0.0001).,['135 puerperal women with iron deficiency anemia'],"['total amount of 1000 mg low molecular weight (LMW) iron-dextran intravenously in two doses', 'Total infusion of low molecular weight iron-dextran']","['adverse side-effects', 'levels', 'Hemoglobin and ferritin']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0022092', 'cui_str': 'Iron-Dextran Complex'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}]",135.0,0.0765898,levels increased significantly in group A compared to group B (p < 0.0001).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Daniilidis', 'Affiliation': '2nd Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Hippokration General Hospital, Thessaloniki, Greece. angedan@hotmail.com'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Giannoulis', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pantelis', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tantanasis', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dinas', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1007,21485728,A prospective randomized study for evaluation of wound retractors in the prevention of incision site infections after cesarean section.,"Surgical site infections (SSIs) after cesarean section appear to be more common than generally believed. We prospectively evaluated 231 consecutive pregnant women who underwent elective or emergency cesarean section, and were assigned to have either the Alexis wound retractor (study group) or a conventional Doyen retractor (control group) during the operation. There was no evidence of SSI, defined as wound dehiscence, pain or tenderness in the lower abdomen, localized swelling, redness, heat or purulent discharge from the wound in any woman in the study group. Moreover, no endometritis occurred in this patient collective. There were three SSI in the control group, but no endometritis. Our preliminary data show excellent protection of wound infections with an additive protective effect to that given by antibiotic cover. After a short learning curve, the handling of the Alexis device became easier and the median insertion time was 18 sec.",2011,"There was no evidence of SSI, defined as wound dehiscence, pain or tenderness in the lower abdomen, localized swelling, redness, heat or purulent discharge from the wound in any woman in the study group.","['231 consecutive pregnant women who underwent elective or emergency cesarean section, and were assigned to have either the', 'incision site infections after cesarean section']","['wound retractors', 'Alexis wound retractor (study group) or a conventional Doyen retractor (control group) during the operation']","['median insertion time', 'wound dehiscence, pain or tenderness in the lower abdomen, localized swelling, redness, heat or purulent discharge', 'endometritis']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0558380', 'cui_str': 'Emergency cesarean section'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1698397', 'cui_str': 'Incision site infection'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0183014', 'cui_str': 'Retractor'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence (morphologic abnormality)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0230166', 'cui_str': 'Lower abdomen structure'}, {'cui': 'C0853619', 'cui_str': 'Localized swelling (morphologic abnormality)'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1305623', 'cui_str': 'Purulent discharge'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}]",231.0,0.0385947,"There was no evidence of SSI, defined as wound dehiscence, pain or tenderness in the lower abdomen, localized swelling, redness, heat or purulent discharge from the wound in any woman in the study group.","[{'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Theodoridis', 'Affiliation': '1(st) Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece. theodtheo@yahoo.gr'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Chatzigeorgiou', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zepiridis', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Papanicolaou', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vavilis', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Tzevelekis', 'Affiliation': ''}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'Tarlatzis', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1008,31530570,User-driven design of child restraint information to reduce errors in use: a pilot randomised controlled trial.,"BACKGROUND


Incorrect use of child restraints is a long-standing problem that increases the risk of injury in crashes. We used user-centred design to develop prototype child restraint instructional materials. The objective of this study was to evaluate these materials in terms of comprehension and errors in the use of child restraints. The relationship between comprehension and errors in use was also explored.
METHODS


We used a parallel-group randomised controlled trial in a laboratory setting. The intervention group (n=22) were provided with prototype materials and the control group (n=22) with existing instructional materials for the same restraint. Participants installed the restraint in a vehicle buck, secured an appropriately sized mannequin in the restraint and underwent a comprehension test. Our primary outcome was overall correct use, and our secondary outcomes were (1) comprehension score and (2) percent errors in the installation trial.
RESULTS


There was 27% more overall correct use (p=0.042) and a higher mean comprehension score in the intervention group (mean 17, 95% CI 16 to 18) compared with the control group (mean 12, 95% CI 10 to 14, p<0.001). The mean error percentage in the control group was 23% (95% CI 16% to 31%) compared with 14% in the intervention group (95% CI 8% to 20%, p=0.056). For every one point increase in comprehension, there was an almost 2% (95% CI -2.7% to -1.0%) reduction in errors (y=45.5-1.87x, p value for slope <0.001).
CONCLUSIONS


Consumer-driven design of informational materials can increase the correct use of child restraints. Targeting improved comprehension of informational materials may be an effective mechanism for reducing child restraint misuse.",2020,"There was 27% more overall correct use (p=0.042) and a higher mean comprehension score in the intervention group (mean 17, 95% CI 16 to 18) compared with the control group (mean 12, 95% CI 10 to 14, p<0.001).",[],['prototype materials and the control group (n=22) with existing instructional materials'],"['comprehension', 'mean error percentage', 'overall correct use', 'mean comprehension score', 'overall correct use, and our secondary outcomes were (1) comprehension score and (2) percent errors']",[],"[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",,0.141869,"There was 27% more overall correct use (p=0.042) and a higher mean comprehension score in the intervention group (mean 17, 95% CI 16 to 18) compared with the control group (mean 12, 95% CI 10 to 14, p<0.001).","[{'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Hall', 'Affiliation': 'Neuroscience Research Australia, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ho', 'Affiliation': 'Neuroscience Research Australia, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Albanese', 'Affiliation': 'Neuroscience Research Australia, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Keay', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunter', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Charlton', 'Affiliation': 'Accident Research Centre, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hayen', 'Affiliation': 'Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Bilston', 'Affiliation': 'Neuroscience Research Australia, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Neuroscience Research Australia, University of New South Wales, Sydney, New South Wales, Australia j.brown@neura.edu.au.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2019-043380']
1009,21077506,Is placebo as effective as estrogen regimens on vasomotor symptoms in women with surgical menopause?,"OBJECTIVE


To evaluate the short-term effects of two hormone therapy (HT) regimens and placebo on the Greene Climacteric Scale (GCS) of women with surgical menopause following six months of treatment.
METHODS


This 6-month, prospective, randomized, parallel-group, masked evaluator study compared the efficacy of once daily administration of 0.625 mg conjugated equine estrogen (group I), 3.9 mg transdermal 17beta-estradiol patch applied every week (group II) and placebo (group III). Mean GCS before and after six months of treatment in each group was compared.
RESULTS


In groups I and II, vasomotor symptoms (p < 0.005, p < 0.05), somatic symptoms (p < 0.05, p < 0.05) and total score (p < 0.005, p < 0.01) significantly reduced from baseline values respectively, while the other subscores revealed no statistically important differences following six months of HT. In group III, vasomotor (p < 0.05), subscore and total score (p < 0.05) decreased significantly while other subscore reductions were not significant.
CONCLUSIONS


Estrogen regimens and placebo seem to be effective in alleviating vasomotor symptoms. Additional larger prospective randomized studies need to be conducted in an aim to look at not only short-term but also long-term effects on climacteric symptoms, in comparison to both placebo arms and different dose and mode of HT use.",2010,"In groups I and II, vasomotor symptoms (p < 0.005, p < 0.05), somatic symptoms (p < 0.05, p < 0.05) and total score (p < 0.005, p < 0.01) significantly reduced from baseline values respectively, while the other subscores revealed no statistically important differences following six months of HT.","['women with surgical menopause following six months of treatment', 'women with surgical menopause']","['hormone therapy (HT) regimens and placebo', 'conjugated equine estrogen', 'placebo']","['climacteric symptoms', 'subscore and total score', 'vasomotor symptoms', 'somatic symptoms', 'total score', 'Greene Climacteric Scale (GCS', 'Mean GCS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740421', 'cui_str': 'Postsurgical menopause'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1136013', 'cui_str': 'Conjugated Equine Estrogens'}]","[{'cui': 'C1306878', 'cui_str': 'Climacteric discomfort'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3839861', 'cui_str': 'Medically Unexplained Symptoms'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.125798,"In groups I and II, vasomotor symptoms (p < 0.005, p < 0.05), somatic symptoms (p < 0.05, p < 0.05) and total score (p < 0.005, p < 0.01) significantly reduced from baseline values respectively, while the other subscores revealed no statistically important differences following six months of HT.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hassa', 'Affiliation': 'Department of Obstetrics and Gynecology, Eskisehir Osmangazi University Faculty of Medicine, Eskisehir, Turkey.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Tanir', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Oge', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1010,31537908,"Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer.","BACKGROUND


Trabectedin, in addition to its antiproliferative effect, can modify the tumour microenvironment and this could be synergistic with bevacizumab. The efficacy and safety of trabectedin and bevacizumab ± carboplatin have never been investigated.
METHODS


In this phase 2 study, women progressing between 6 and 12 months since their last platinum-based therapy were randomised to Arm BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin every 28 days, from cycles 1 to 6, then trabectedin and bevacizumab as in Arm BT. Primary endpoints were progression-free survival rate (PFS-6) and severe toxicity rate (ST-6) at 6 months, assuming a PFS-6 ≤35% for BT and ≤40% for BT+C as not of therapeutic interest and, for both arms, a ST-6  ≥ 30% as unacceptable.
RESULTS


BT+C (21 patients) did not meet the safety criteria for the second stage (ST-6 45%; 95%CI: 23%-69%) but PFS-6 was 85% (95%CI: 62%-97%). BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
CONCLUSIONS


BT compared favourably with other platinum- and non-platinum-based regimens. The combination with carboplatin needs to be assessed further in a re-modulated safer schedule to confirm its apparent strong activity.
CLINICAL TRIAL REGISTRATION


NCT01735071 (Clinicaltrials.gov).",2019,"BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
","['women with partially platinum-sensitive recurrent ovarian cancer', 'women progressing between 6 and 12 months since their last platinum-based therapy']","['BT: bevacizumab, trabectedin every 21 days, or Arm BT+C: bevacizumab, trabectedin and carboplatin', 'bevacizumab', 'trabectedin and bevacizumab', 'bevacizumab and trabectedin with or without carboplatin']","['efficacy and safety', 'progression-free survival rate (PFS-6) and severe toxicity rate (ST-6']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.202843,"BT (50 patients) had 75% PFS-6 (95%CI: 60%-87%) and 16% ST-6 (95%CI 7%-30%).
","[{'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Zaccarelli', 'Affiliation': 'Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Baldoni', 'Affiliation': 'Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Frezzini', 'Affiliation': 'Istituto Oncologico Veneto, IOV-IRCCS, Padova, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Palluzzi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, Roma, Italy.'}, {'ForeName': 'Germana', 'Initials': 'G', 'LastName': 'Tognon', 'Affiliation': 'UO Ostetricia e Ginecologia - ASST degli Spedali Civili di Brescia, Università degli Studi, Brescia, Italy.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Lissoni', 'Affiliation': 'Università di Milano-Bicocca, Clinica Ostetrica e Ginecologica, Milano, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Policlinico S. Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Ferrero', 'Affiliation': 'AO Ordine Mauriziano, SCDU Ginecologia ed Ostetricia, Torino, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Farina', 'Affiliation': 'ASST Fatebenefratelli Sacco, UOC di Oncologia, Milano, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Negri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pesenti Gritti', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Biagioli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Poli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Gerardi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Roldano', 'Initials': 'R', 'LastName': 'Fossati', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy. roldano.fossati@marionegri.it.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': ""D'Incalci"", 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}]",British journal of cancer,['10.1038/s41416-019-0584-5']
1011,31313118,Associations of Diabetes Genetic Risk Counseling with Incident Diabetes and Weight: 5-Year Follow-up of a Randomized Controlled Trial.,,2020,,[],[],[],[],[],[],,0.0738647,,"[{'ForeName': 'Sridharan', 'Initials': 'S', 'LastName': 'Raghavan', 'Affiliation': 'Department of Veterans Affairs Eastern Colorado Health Care System, Aurora, CO, USA. Sridharan.raghavan@ucdenver.edu.'}, {'ForeName': 'Kerui', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham, NC, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Pabich', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham, NC, USA.'}, {'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05126-z']
1012,20739842,Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial.,"BACKGROUND AND OBJECTIVE


Sentinel lymph node dissection (SLND) has eliminated the need for axillary dissection (ALND) in patients whose sentinel node (SN) is tumor-free. However, completion ALND for patients with tumor-involved SNs remains the standard to achieve locoregional control. Few studies have examined the outcome of patients who do not undergo ALND for positive SNs. We now report local and regional recurrence information from the American College of Surgeons Oncology Group Z0011 trial.
METHODS


American College of Surgeons Oncology Group Z0011 was a prospective trial examining survival of patients with SN metastases detected by standard H and E, who were randomized to undergo ALND after SLND versus SLND alone without specific axillary treatment. Locoregional recurrence was evaluated.
RESULTS


There were 446 patients randomized to SLND alone and 445 to SLND + ALND. Patients in the 2 groups were similar with respect to age, Bloom-Richardson score, estrogen receptor status, use of adjuvant systemic therapy, tumor type, T stage, and tumor size. Patients randomized to SLND + ALND had a median of 17 axillary nodes removed compared with a median of only 2 SN removed with SLND alone (P < 0.001). ALND also removed more positive lymph nodes (P < 0.001). At a median follow-up time of 6.3 years, there were no statistically significant differences in local recurrence (P = 0.11) or regional recurrence (P = 0.45) between the 2 groups.
CONCLUSIONS


Despite the potential for residual axillary disease after SLND, SLND without ALND can offer excellent regional control and may be reasonable management for selected patients with early-stage breast cancer treated with breast-conserving therapy and adjuvant systemic therapy.",2010,"At a median follow-up time of 6.3 years, there were no statistically significant differences in local recurrence (P = 0.11) or regional recurrence (P = 0.45) between the 2 groups.
","['American College of Surgeons Oncology Group', 'patients with SN metastases detected by standard H and E', 'selected patients with early-stage breast cancer treated with breast-conserving therapy and adjuvant systemic therapy', 'patients who do not undergo ALND for positive SNs', '446 patients randomized to', 'patients with sentinel lymph node metastases', 'American College of Surgeons Oncology Group Z0011 trial']","['ALND after SLND versus SLND alone without specific axillary treatment', 'SLND + ALND', 'SLND alone and 445 to SLND + ALND', 'sentinel lymph node dissection with or without axillary dissection']","['local recurrence', 'positive lymph nodes', 'regional recurrence', 'Locoregional recurrence']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",446.0,0.115058,"At a median follow-up time of 6.3 years, there were no statistically significant differences in local recurrence (P = 0.11) or regional recurrence (P = 0.45) between the 2 groups.
","[{'ForeName': 'Armando E', 'Initials': 'AE', 'LastName': 'Giuliano', 'Affiliation': ""John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, CA 90404, USA. giulianoa@jwci.org""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'McCall', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Beitsch', 'Affiliation': ''}, {'ForeName': 'Pat W', 'Initials': 'PW', 'LastName': 'Whitworth', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Blumencranz', 'Affiliation': ''}, {'ForeName': 'A Marilyn', 'Initials': 'AM', 'LastName': 'Leitch', 'Affiliation': ''}, {'ForeName': 'Sukamal', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': ''}, {'ForeName': 'Kelly K', 'Initials': 'KK', 'LastName': 'Hunt', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Morrow', 'Affiliation': ''}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Ballman', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0b013e3181f08f32']
1013,22367706,Neoadjuvant chemotherapy in MRI-staged high-risk rectal cancer in addition to or as an alternative to preoperative chemoradiation?,"BACKGROUND


For patients with resectable rectal cancer chemoradiation (CRT) or short-course preoperative radiotherapy (SCPRT) reduces locoregional failure, without extending disease-free survival (DFS) or overall survival (OS). Compliance to postoperative adjuvant chemotherapy is poor. Neoadjuvant chemotherapy (NACT) offers an alternative strategy.
METHODS


A systematic computerised database search identified studies exploring NACT alone or NACT preceding/succeeding radiation. The primary outcome measure was pathological complete response (pCR). Secondary outcome measures included acute toxicity, surgical morbidity, circumferential resection margin, locoregional failure, DFS and OS.
RESULTS


Four case reports, 12 phase I/II studies, 4 randomised phase II and one randomised phase III study evaluated chemotherapy before CRT. Four prospective studies reviewed chemotherapy after CRT. Three phase II studies investigated chemotherapy using FOLFOX plus bevacizumab without radiotherapy. In 24 studies of 1271 patients, pCR varied from 7% to 36%, but with no impact on metastatic disease.
CONCLUSIONS


NACT before CRT delivers does not compromise CRT but has not increased pCR rates, R0 resection rate, improved DFS or reduced metastases. NACT following CRT is an interesting strategy, and the utility of NACT alone could be explored compared with SCPRT or CRT in selected patients with rectal cancer where the impact of radiotherapy on DFS and OS is marginal.",2012,"CONCLUSIONS


NACT before CRT delivers does not compromise CRT but has not increased pCR rates, R0 resection rate, improved DFS or reduced metastases.","['selected patients with rectal cancer', 'patients with resectable rectal cancer chemoradiation (CRT) or', 'MRI-staged high-risk rectal cancer']","['FOLFOX plus bevacizumab without radiotherapy', 'Neoadjuvant chemotherapy (NACT', 'NACT', 'NACT alone or NACT', 'short-course preoperative radiotherapy (SCPRT', 'Neoadjuvant chemotherapy', 'radiotherapy', 'SCPRT or CRT']","['pCR', 'locoregional failure, without extending disease-free survival (DFS) or overall survival (OS', 'pCR rates, R0 resection rate, improved DFS or reduced metastases', 'metastatic disease', 'acute toxicity, surgical morbidity, circumferential resection margin, locoregional failure, DFS and OS', 'pathological complete response (pCR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1300632', 'cui_str': 'Surgical circumferential margin finding'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",1271.0,0.0655702,"CONCLUSIONS


NACT before CRT delivers does not compromise CRT but has not increased pCR rates, R0 resection rate, improved DFS or reduced metastases.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, UK. Electronic address: rob.glynnejones@nhs.net.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Anyamene', 'Affiliation': 'Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Moran', 'Affiliation': 'Basingstoke and North Hampshire Hospital NHS Foundation Trust, Basingstoke, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': 'Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds010']
1014,21077526,Comparison of bolus remifentanil-propofol versus bolus fentanyl-propofol for dilatation and sharp curettage.,"BACKGROUND AND OBJECTIVE


The study was conducted to determine whether bolus administrations of remifentanil-propofol could provide adequate analgesia and similar patient comfort with a faster recovery profile compared with bolus administrations of fentanyl-propofol during dilatation and sharp curettage.
METHODS


The patients were randomized to a remifentanil group (n=36) or fentanyl group (n=36). The remifentanil group received an IV bolus dose of 1 pg kg(-1) remifentanil. The fentanyl group received an IV bolus dose of fentanyl 0.5 microg kg(-1). The Verbal Pain Scale (VPS), modified Aldrete scores, blood pressure, heart rate, peripheric oxygen saturation, recovery time from anesthesia and adverse events during or after surgery were evaluated.
RESULTS


The groups were found to be similar in duration of the surgical procedure, anesthesia time and hemodynamic variables and VPS scores. Patients in the remifentanil group recovered from anesthesia earlier. Modified Aldrete scores were higher in the remifentanil group at 5 and 10 min postoperatively. The frequency of perioperative adverse events did not differ significantly between the groups.
CONCLUSIONS


Bolus injections of remifentanil appear to be a safe and effective alternative to fentanyl, producing faster recovery in providing analgesia during dilatation and sharp curettage procedures.",2010,"The groups were found to be similar in duration of the surgical procedure, anesthesia time and hemodynamic variables and VPS scores.",['dilatation and sharp curettage'],"['IV bolus dose of 1 pg kg(-1) remifentanil', 'remifentanil-propofol', 'fentanyl 0.5 microg kg(-1', 'fentanyl', 'fentanyl-propofol', 'remifentanil']","['frequency of perioperative adverse events', 'Modified Aldrete scores', 'Verbal Pain Scale (VPS), modified Aldrete scores, blood pressure, heart rate, peripheric oxygen saturation, recovery time from anesthesia and adverse events', 'duration of the surgical procedure, anesthesia time and hemodynamic variables and VPS scores']","[{'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1444775', 'cui_str': 'Sharp'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3164884', 'cui_str': 'Modified Aldrete score (assessment scale)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0389935,"The groups were found to be similar in duration of the surgical procedure, anesthesia time and hemodynamic variables and VPS scores.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Oğurlu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Adnan Menderes University, Aydin, USA. drmustafaogurlu@yahoo.com'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Küçük', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bilgin', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sizlan', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Yanarateş', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Eksert', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Karaşahin', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kurt', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1015,21096475,Clinical study of neurorehabilitation in stroke using EEG-based motor imagery brain-computer interface with robotic feedback.,"This clinical study investigates the ability of hemiparetic stroke patients in operating EEG-based motor imagery brain-computer interface (MI-BCI). It also assesses the efficacy in motor improvements on the stroke-affected upper limb using EEG-based MI-BCI with robotic feedback neurorehabilitation compared to robotic rehabilitation that delivers movement therapy. 54 hemiparetic stroke patients with mean age of 51.8 and baseline Fugl-Meyer Assessment (FMA) 14.9 (out of 66, higher = better) were recruited. Results showed that 48 subjects (89%) operated EEG-based MI-BCI better than at chance level, and their ability to operate EEG-based MI-BCI is not correlated to their baseline FMA (r=0.358). Those subjects who gave consent are randomly assigned to each group (N=11 and 14) for 12 1-hour rehabilitation sessions for 4 weeks. Significant gains in FMA scores were observed in both groups at post-rehabilitation (4.5, 6.2; p=0.032, 0.003) and 2-month post-rehabilitation (5.3, 7.3; p=0.020, 0.013), but no significant differences were observed between groups (p=0.512, 0.550). Hence, this study showed evidences that a majority of hemiparetic stroke patients can operate EEG-based MI-BCI, and that EEG-based MI-BCI with robotic feedback neurorehabilitation is effective in restoring upper extremities motor function in stroke.",2010,"Significant gains in FMA scores were observed in both groups at post-rehabilitation (4.5, 6.2; p=0.032, 0.003) and 2-month post-rehabilitation (5.3, 7.3; p=0.020, 0.013), but no significant differences were observed between groups (p=0.512, 0.550).","['hemiparetic stroke patients in operating', 'hemiparetic stroke patients', '54 hemiparetic stroke patients with mean age of 51.8 and baseline Fugl-Meyer Assessment (FMA) 14.9 (out of 66, higher = better) were recruited']","['EEG-based motor imagery brain-computer interface (MI-BCI', 'EEG-based motor imagery brain-computer interface with robotic feedback']",['FMA scores'],"[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interfaces'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0146955,"Significant gains in FMA scores were observed in both groups at post-rehabilitation (4.5, 6.2; p=0.032, 0.003) and 2-month post-rehabilitation (5.3, 7.3; p=0.020, 0.013), but no significant differences were observed between groups (p=0.512, 0.550).","[{'ForeName': 'Kai Keng', 'Initials': 'KK', 'LastName': 'Ang', 'Affiliation': 'Institute for Infocomm Research, Agency for Science, Technology and Research (A*STAR), 21 Heng Mui Keng Terrace, Singapore 119613. kkang@i2r.a-star.edu.sg'}, {'ForeName': 'Cuntai', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': ''}, {'ForeName': 'Karen Sui Geok', 'Initials': 'KS', 'LastName': 'Chua', 'Affiliation': ''}, {'ForeName': 'Beng Ti', 'Initials': 'BT', 'LastName': 'Ang', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kuah', 'Affiliation': ''}, {'ForeName': 'Chuanchu', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Kok Soon', 'Initials': 'KS', 'LastName': 'Phua', 'Affiliation': ''}, {'ForeName': 'Zheng Yang', 'Initials': 'ZY', 'LastName': 'Chin', 'Affiliation': ''}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2010.5626782']
1016,21096598,Anisotropic diffusion tensor applied to temporal mammograms: an application to breast cancer risk assessment.,"Breast density is considered a structural property of a mammogram that can change in various ways explaining different effects of medicinal treatments. The aim of the present work is to provide a framework for obtaining more accurate and sensitive measurements of breast density changes related to specific effects like Hormonal Replacement Therapy (HRT) and aging. Given effect-grouped patient data, we demonstrated how the diffusion tensor and its coherence features computed in an anatomically oriented breast coordinate system followed by statistical learning scheme provides non subjective and reproducible measure, as compared to the traditional BIRADS and computer aided percent density measure. We also demonstrate how orientation of breast tissue changes in temporal study. This framework facilitates radiologist to assess breast tissue change and guide them to evaluate individual risk of having breast cancer.",2010,"Given effect-grouped patient data, we demonstrated how the diffusion tensor and its coherence features computed in an anatomically oriented breast coordinate system followed by statistical learning scheme provides non subjective and reproducible measure, as compared to the traditional BIRADS and computer aided percent density measure.",[],['Anisotropic diffusion tensor applied to temporal mammograms'],[],[],"[{'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]",[],,0.0118337,"Given effect-grouped patient data, we demonstrated how the diffusion tensor and its coherence features computed in an anatomically oriented breast coordinate system followed by statistical learning scheme provides non subjective and reproducible measure, as compared to the traditional BIRADS and computer aided percent density measure.","[{'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Karemore', 'Affiliation': 'University of Copenhagen and Nordic Bioscience Imaging A/S, Herlev Hovedgade 203, 2730, Denmark. gp@nordicbioscience.com'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Brandt', 'Affiliation': ''}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Sporring', 'Affiliation': ''}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Nielsen', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2010.5627183']
1017,22492697,Laryngeal preservation with induction chemotherapy for hypopharyngeal squamous cell carcinoma: 10-year results of EORTC trial 24891.,"BACKGROUND


We report the 10-year results of the EORTC trial 24891 comparing a larynx-preservation approach to immediate surgery in hypopharynx and lateral epilarynx squamous cell carcinoma.
MATERIAL AND METHODS


Two hundred and two patients were randomized to either the surgical approach (total laryngectomy with partial pharyngectomy and neck dissection, followed by irradiation) or to the chemotherapy arm up to three cycles of induction chemotherapy (cisplatin 100 mg/m(2) day 1 + 5-FU 1000 mg/m(2) day 1-5) followed for complete responders by irradiation and otherwise by conventional treatment. The end points were overall survival [OS, noninferiority: hazard ratio (preservation/surgery) ≤ 1.428, one-sided α = 0.05], progression-free survival (PFS) and survival with a functional larynx (SFL).
RESULTS


At a median follow-up of 10.5 years on 194 eligible patients, disease evolution was seen in 54 and 49 patients in the surgery and chemotherapy arm, respectively, and 81 and 83 patients had died. The 10-year OS rate was 13.8% in the surgery arm and 13.1% in the chemotherapy arm. The 10-year PFS rates were 8.5% and 10.8%, respectively. In the chemotherapy arm, the 10-year SFL rate was 8.7%.
CONCLUSION


This strategy did not compromise disease control or survival (that remained poor) and allowed more than half of the survivors to retain their larynx.",2012,The 10-year OS rate was 13.8% in the surgery arm and 13.1% in the chemotherapy arm.,"['hypopharynx and lateral epilarynx squamous cell carcinoma', 'Two hundred and two patients', 'hypopharyngeal squamous cell carcinoma']","['larynx-preservation approach to immediate surgery', 'Laryngeal preservation with induction chemotherapy', 'surgical approach (total laryngectomy with partial pharyngectomy and neck dissection, followed by irradiation) or to the chemotherapy arm up to three cycles of induction chemotherapy (cisplatin 100 mg/m(2) day 1 + 5-FU 1000 mg/m(2) day 1-5) followed for complete responders by irradiation and otherwise by conventional treatment']","['10-year SFL rate', 'died', 'disease evolution', '10-year PFS rates', 'progression-free survival (PFS) and survival with a functional larynx (SFL', '10-year OS rate', 'overall survival [OS, noninferiority: hazard ratio (preservation/surgery']","[{'cui': 'C0020629', 'cui_str': 'Laryngopharynx'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0449446', 'cui_str': 'Surgical approach (attribute)'}, {'cui': 'C0189231', 'cui_str': 'Total laryngectomy (procedure)'}, {'cui': 'C0192220', 'cui_str': 'Partial pharyngectomy (procedure)'}, {'cui': 'C0398395', 'cui_str': 'Neck Dissection'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",202.0,0.0788803,The 10-year OS rate was 13.8% in the surgery arm and 13.1% in the chemotherapy arm.,"[{'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Lefebvre', 'Affiliation': 'Head and Neck Cancer Department, Centre Oscar Lambret, Lille, France. Electronic address: jl-lefebvre@o-lambret.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Andry', 'Affiliation': 'Surgery Department, Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Chevalier', 'Affiliation': 'Otolaryngology Department, Centre Hospitalier Régional Claude Huriez, Lille.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Luboinski', 'Affiliation': 'Surgery Department, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Collette', 'Affiliation': 'Statistics Department, EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Traissac', 'Affiliation': 'Oto-Rhino-Laryngeology Department, Hôpital Pellegrin, Bordeaux.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'de Raucourt', 'Affiliation': 'Facial Surgery Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds065']
1018,31533605,"Synergism Effects of Ursolic Acid Supplementation on the Levels of Irisin, C-reactive Protein, IL-6, and TNF-α During High-intensity Resistance Training in Low Activity Men.","BACKGROUND


Ursolic Acid (UA) is a pentacyclic triterpenoid carboxylic acid which is extracted from plants. UA may enhance the effect of Resistance Training (RT) in human.
OBJECTIVE


Current research was designed to show the effect of High-Intensity Resistance Training (HIRT) in the presence or absence of UA on the serum levels of irisin, CRP, IL-6 and TNF-α in the low activity men.
METHODS


The study included twenty-two healthy male HIRT with placebo, supplementation, and HIRT in the presence of UA supplementation. The two groups received eight-week intervention including 2 sets of 8 exercises, with 8~10 repetitions at 70~75% of 1 repetition maximum and a 2 min rest interval between sets, performed 3 times/week. Placebo or UA orally was evaluated as 1 capsule 3 times/day during 8 weeks. The subsequent factors were measured post- and preintervention: C-Reactive Protein (CRP), Irisin, Tumor Necrotic Factor (TNF-α) and Interleukin-6 (IL-6).
RESULTS


UA supplementation significantly increased the plasma levels of irisin in the HIRT+UA group versus the HIRT+P group (p<0.05). UA treatment also dramatically decreased the plasma levels of CRP, IL-6, and TNF-α in the HIRT+UA group versus the HIRT+P group (p<0.05).
CONCLUSION


The current data showed that UA-induced an increase in serum irisin and reduction of CRP, IL-6, and TNF-α may have beneficial effects as a chemical for increasing of the effects of HIRT in low activity men.",2020,"UA treatment also dramatically decreased the plasma levels of CRP, IL-6, and TNF-α in the HIRT+UA group versus the HIRT+P group (p<0.05).
","['low activity men', 'Twenty-two healthy male HIRT with placebo, supplementation, and HIRT in presence of UA supplementation']","['Placebo', 'HIRT+P', 'ursolic acid supplementation', 'high-intensity resistance training (HIRT']","['levels of irisin, C-reactive protein, IL-6, and TNF-α', 'reactive protein (CRP), irisin, tumor necrotic factor (TNF-α) and interleukin-6 (IL-6', 'plasma levels of CRP, IL-6, and TNF-α', 'serum irisin and reduction of CRP, IL-6, and TNF-α', 'serum levels of irisin, CRP, IL-6, and TNF-α', 'plasma levels of irisin']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0077938', 'cui_str': 'ursolic acid'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",22.0,0.0467723,"UA treatment also dramatically decreased the plasma levels of CRP, IL-6, and TNF-α in the HIRT+UA group versus the HIRT+P group (p<0.05).
","[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Asghari', 'Affiliation': 'Department of Physical Education and Sport Sciences, Faculty of Sport Science, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Rashidlamir', 'Affiliation': 'Department of Physical Education and Sport Sciences, Faculty of Sport Science, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Seyyed R A', 'Initials': 'SRA', 'LastName': 'Hosseini', 'Affiliation': 'Department of Physical Education and Sport Sciences, Faculty of Sport Science, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Moazzami', 'Affiliation': 'Department of Physical Education and Sport Sciences, Faculty of Sport Science, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Samarghandian', 'Affiliation': 'Department of Basic Medical Sciences, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Farkhondeh', 'Affiliation': 'Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Birjand, Iran.'}]",Cardiovascular & hematological disorders drug targets,['10.2174/1871529X19666190918144727']
1019,20810589,Self-help and community mental health agency outcomes: a recovery-focused randomized controlled trial.,"OBJECTIVE


Self-help agencies (SHAs) are consumer-operated service organizations managed as participatory democracies. Members are involved in all aspects of organizational management, because a premise of SHAs is that organizationally empowered individuals become more empowered in their own lives, which promotes recovery. The study sought to determine the effectiveness of combined SHA and community mental health agency (CMHA) services in assisting recovery for persons with serious mental illness.
METHODS


A weighted sample of new clients seeking CMHA services was randomly assigned to regular CMHA services or to combined SHA-CMHA services at five proximally located pairs of SHA drop-in centers and county CMHAs. Member-clients (N=505) were assessed at baseline and at one, three, and eight months on five recovery-focused outcome measures: personal empowerment, self-efficacy, social integration, hope, and psychological functioning. Scales had high levels of reliability and independently established validity. Outcomes were evaluated with a repeated-measures multivariate analysis of covariance.
RESULTS


Overall results indicated that combined SHA-CMHA services were significantly better able to promote recovery of client-members than CMHA services alone. The sample with combined services showed greater improvements in personal empowerment (F=3.99, df=3 and 491, p<.008), self-efficacy (F=11.20, df=3 and 491, p<.001), and independent social integration (F=12.13, df=3 and 491, p<.001). Hopelessness (F=4.36, df=3 and 491, p<.005) and symptoms (F=4.49, df=3 and 491, p<.004) dissipated more quickly and to a greater extent in the combined condition than in the CMHA-only condition.
CONCLUSIONS


Member-empowering SHAs run as participatory democracies in combination with CMHA services produced more positive recovery-focused results than CMHA services alone.",2010,"The sample with combined services showed greater improvements in personal empowerment (F=3.99, df=3 and 491, p<.008), self-efficacy (F=11.20, df=3 and 491, p<.001), and independent social integration (F=12.13, df=3 and 491, p<.001).","['A weighted sample of new clients seeking CMHA services', 'persons with serious mental illness']","['regular CMHA services or to combined SHA-CMHA services at five proximally located pairs of SHA drop-in centers and county CMHAs', 'combined SHA and community mental health agency (CMHA) services']","['self-efficacy', 'personal empowerment', 'personal empowerment, self-efficacy, social integration, hope, and psychological functioning', 'Hopelessness', 'social integration']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}]",505.0,0.0699377,"The sample with combined services showed greater improvements in personal empowerment (F=3.99, df=3 and 491, p<.008), self-efficacy (F=11.20, df=3 and 491, p<.001), and independent social integration (F=12.13, df=3 and 491, p<.001).","[{'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Segal', 'Affiliation': 'School of Social Welfare, University of California, Berkeley, 120 Haviland Hall (MC 7400), Berkeley, CA 94720-7400, USA. spsegal@berkeley.edu'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Silverman', 'Affiliation': ''}, {'ForeName': 'Tanya L', 'Initials': 'TL', 'LastName': 'Temkin', 'Affiliation': ''}]","Psychiatric services (Washington, D.C.)",['10.1176/ps.2010.61.9.905']
1020,31639321,"Stability of condomless anal sex behaviours of young Black men who have sex with men: implications for HIV prevention, including pre-exposure prophylaxis.","Background Among a sample of young Black men who have sex with men (YBMSM), this study evaluated the stability of annually assessing condomless anal receptive sex (CARS) as an indication for pre-exposure prophylaxis (PrEP) use. Further, the study determined the proportion of YBMSM engaging in CARS rarely (defined as twice or less per year) who may thus may be more efficiently protected by condom use rather than PrEP.
METHODS


This is a secondary analysis of data collected as part of a randomised control trial that recruited 600 YBMSM from a sexually transmissible infection (STI) clinic located in the southern US. Of these, 144 met the inclusion criteria for the present study. Only HIV-uninfected men assigned to the control condition, who completed the 12-month period of observation, were included.
RESULTS


Correlation coefficients between the baseline level of CARS were 0.16 at the first quarter and 0.09, 0.10, and 0.03 at each successive quarter. Discriminant function analysis indicated similarly weak predictive ability of the baseline measure (r = 0.215; P = 0.16). Of 106 reporting no CARS at baseline, 73 (68.9%) had summed scores of zero (no CARS) over the four follow-up assessments. Of 38 reporting any CARS at baseline, 14 (36.8%) had a summed score of zero for the observation period. Of these same 38, 27 (71.0%) had summed scores of two or fewer events of CARS for the observation period.
CONCLUSION


Among YBMSM, CARS in not a stable behaviour over 12 months. Many YBMSM indicated for PrEP may benefit from be a program concurrently promoting condom use.",2019,"Of 106 reporting no CARS at baseline, 73 (68.9%) had summed scores of zero (no CARS) over the four follow-up assessments.","['144 met the inclusion criteria for the present study', 'recruited 600 YBMSM from a sexually transmissible infection (STI) clinic located in the southern US', 'young Black men who have sex with men (YBMSM', 'Only HIV-uninfected men assigned to the control condition, who completed the 12-month period of observation, were included', 'young Black men who have sex with men']",[],['summed scores of zero (no CARS'],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0555044', 'cui_str': 'No car (finding)'}]",106.0,0.0600667,"Of 106 reporting no CARS at baseline, 73 (68.9%) had summed scores of zero (no CARS) over the four follow-up assessments.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Crosby', 'Affiliation': 'College of Public Health, University of Kentucky, 111 Washington Avenue, Lexington, KY 40506, USA; and Kinsey Institute for Research in Sex, Gender, and Reproduction, Lindley Hall, 150 S. Woodlawn Avenue, Bloomington, IN 47405, USA; and Division of Infectious Diseases, University of Mississippi School of Medicine, 2500 N. State Street, Jackson, MS 39216, USA; and Corresponding author. Email: crosbyr3@gmail.com.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Mena', 'Affiliation': 'Division of Infectious Diseases, University of Mississippi School of Medicine, 2500 N. State Street, Jackson, MS 39216, USA; and Department of Population Health Science, John D. Bower School of Population Health, Jackson, MS 39216, USA.'}]",Sexual health,['10.1071/SH18036']
1021,31331234,Sample size computation in phase II designs combining the A'Hern design and the Sargent and Goldberg design.,"This work focuses on the modification of two classical phase II trials designs, the A'Hern design, a single-arm single-stage design, and the Sargent and Goldberg design introduced in the context of flexible screening designs. In the first part of the paper, we have proposed a drift-adjusted A'Hern design, a hybrid design combining the A'Hern design and the Sargent and Goldberg design. Indeed, classical single-arm phase II designs such as the A'Hern design are still widely used in oncology. Conducting randomized comparative phase II trials may be challenging in many settings due to the increased sample size and this despite larger type 1 errors. Randomized non-comparative phase II designs first introduced by Herson and Carter include a simultaneous randomized standard-treatment reference arm to detect any drift in the reference arm assumption, but the trial is analyzed against historical controls as if it were a single-arm study. However, not incorporating at all an internal control arm in the trial design has been criticized in the literature. Our new design takes into account the observed response rate in a non-comparative reference arm to reduce the trial's risk of a false-positive conclusion. In the second part, we have proposed an alternative strategy to determining the sample size of the screened selection design. The latter, introduced in recent years by Yap et al. and Wu et al., extended the Sargent and Goldberg design to include a comparison to a historical control. However, their sample size computations may have potential weaknesses, which motivated us to revisit the existing approaches. A detailed simulation study has been carried out to evaluate the operating characteristics of the drift-adjusted A'Hern design and the different sample size strategies of the screened selection designs.",2020,A detailed simulation study has been carried out to evaluate the operating characteristics of the drift-adjusted A'Hern design and the different sample size strategies of the screened selection designs.,[],[],[],[],[],[],,0.0216145,A detailed simulation study has been carried out to evaluate the operating characteristics of the drift-adjusted A'Hern design and the different sample size strategies of the screened selection designs.,"[{'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Neven', 'Affiliation': 'EORTC Headquarters, Statistics Department, Brussels, Belgium.'}, {'ForeName': 'Murielle', 'Initials': 'M', 'LastName': 'Mauer', 'Affiliation': 'EORTC Headquarters, Statistics Department, Brussels, Belgium.'}, {'ForeName': 'Baktiar', 'Initials': 'B', 'LastName': 'Hasan', 'Affiliation': 'EORTC Headquarters, Statistics Department, Brussels, Belgium.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sylvester', 'Affiliation': 'EORTC Headquarters, Statistics Department, Brussels, Belgium.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Collette', 'Affiliation': 'EORTC Headquarters, Statistics Department, Brussels, Belgium.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2019.1641817']
1022,20101851,A prospective comparison of in vitro fertilization (IVF) outcome following controlled ovarian hyperstimulation (COH) regimens using follitropin alpha exclusively or with the addition of low dose human chorionic gonadotropin (hCG) and ganirelix.,"PURPOSE


To determine if the addition of luteinizing hormone (LH) activity to a controlled ovarian hyperstimulation regimen for purposes of in vitro fertilization adds any additional benefit to the exclusive use of recombinant (r) FSH in antagonist protocols.
METHODS


Women with normal endogenous gonadotropin levels were randomly assigned to receive either follitropin alpha exclusively or have the addition of 25 IU human chorionic gonadotropin (hCG) daily. Ganirelix was used when a 14 mm follicle was attained. The data would be analyzed after 70 women were selected for the study and divided into two groups.
RESULTS


There were 22 women in each group who proceeded with embryo transfer (some purposely cryopreserved all embryos because of risk of ovarian hyperstimulation syndrome). There were no trends for differences in clinical or delivered pregnancy rates or implantation rates.
CONCLUSIONS


There does not appear to be any clinical advantage of adding exogenous LH activity to the drug regimen for stimulation of multiple follicles for purposes of in vitro fertilization when using follitropin alpha in an antagonist protocol.",2009,There does not appear to be any clinical advantage of adding exogenous LH activity to the drug regimen for stimulation of multiple follicles for purposes of in vitro fertilization when using follitropin alpha in an antagonist protocol.,"['Women with normal endogenous gonadotropin levels', '70 women were selected for the study and divided into two groups', '22 women in each group who proceeded with embryo transfer (some purposely cryopreserved all embryos because of risk of ovarian hyperstimulation syndrome']","['low dose human chorionic gonadotropin (hCG) and ganirelix', 'luteinizing hormone (LH) activity', 'vitro fertilization (IVF', 'follitropin alpha exclusively or have the addition of 25 IU human chorionic gonadotropin (hCG) daily']",['clinical or delivered pregnancy rates or implantation rates'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0542494', 'cui_str': 'Finding of gonadotrophin level (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0085083', 'cui_str': 'Ovarian Hyperstimulation Syndrome'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C0073629', 'cui_str': 'ganirelix'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",70.0,0.0697099,There does not appear to be any clinical advantage of adding exogenous LH activity to the drug regimen for stimulation of multiple follicles for purposes of in vitro fertilization when using follitropin alpha in an antagonist protocol.,"[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Check', 'Affiliation': 'The University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical School at Camden, Cooper Hospital/University Medical Center Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology & Infertility, Camden, NJ, USA. laurie@ccivf.com'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brasile', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Choe', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Amui', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1023,20101858,A comparison of low-dose and high-dose protocols of vaginal misoprostol for second trimester termination of pregnancy.,"Sixty patients were randomized to low-dose and high-dose groups, receiving a maximum total dose 1400 g of misoprostol by the vaginal route to compare the efficacy of the protocols for second trimester termination of pregnancy. Outcome measures to be compared between the groups were success rates, time to termination, blood loss, complications and side-effects. Yet time to termination was significantly shorter in the high-dose than in the low-dose group (923 +/- 571 vs 1307 +/- 828 min; p < 0.05). The distance between the internal cervical os and the placenta was positively correlated with the duration of the termination process (r = 0.508, p < 0.001). Induction to the fetal expulsion period is shorter with the higher dose without any significant increase in morbidity. A shorter distance between the internal cervical os and the placenta may forecast a shorter termination process.",2009,Induction to the fetal expulsion period is shorter with the higher dose without any significant increase in morbidity.,"['Sixty patients', 'second trimester termination of pregnancy']","['maximum total dose 1400 g of misoprostol', 'vaginal misoprostol']","['success rates, time to termination, blood loss, complications and side-effects', 'morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032980', 'cui_str': 'Midtrimester'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0538349,Induction to the fetal expulsion period is shorter with the higher dose without any significant increase in morbidity.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ozerkan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Uludağ University, Faculty of Medicine, Bursa, Turkey. doctorkemal@yahoo.com'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ocakoğlu', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rehimli', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Uncu', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Develioğlu', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1024,32073316,Role of Oral Vitamin 'C' on Astigmatic Errors in Phacoemulsification.,"Purpose : To evaluate the role of oral vitamin C on postoperative astigmatism in phacoemulsification and to assess its effect on postoperative symptoms.  Methods : The patients were selected from Department of Ophthalmology, GSVM Medical College, Kanpur who came for cataract surgery.  Design : Prospective, randomized double-blind study; 400 consecutive patients of cataract were randomized into two groups consisting of 200 patients each. Group ""A"" patients were started on oral vitamin C (1,500 mg per day in three divided doses) from the first postoperative day and Group ""B"" patients were given routine postoperative medications along with placebo. The keratometry of both the groups was done preoperatively and postoperatively at 2, 4, and 6 weeks. All patients underwent temporal clear corneal phacoemulsification by the same surgeon.  Results : The mean difference of astigmatism preoperatively in the right eye of Group ""A"" patients was 1.049 ± 0.971 which reduced to 0.680 ± 0.554 at 6 weeks postoperatively ( p -value = 0.0018), whereas in Group B, it changed to 1.141 ± 0.771 at 6 weeks from 1.116 ± 0.566 of preoperatively ( p -value = 0.759). In the left eye of Group ""A"" patients, its value was 0.995 ± 0.899 which changed to 0.574 ± 0.528 at 6 weeks ( p -value = 0.0001) which was highly significant, whereas that in Group ""B"" patients, it was 0.733 ± 0.440 preoperatively which modified to 0.877 ± 0.581 at 6 weeks ( p -value = 0.004). In Group ""A,"" 0.5% patients had pain, foreign body sensation, and photophobia at 6 weeks, whereas in Group ""B"" patients, 5% had pain, 1.5% had foreign body sensation, 1% had photophobia, and 0.5% had watering.  Conclusion : Oral vitamin C may play a beneficial role in decreasing the postoperative astigmatism. It also enhances patients' comfort levels and ensures faster recovery after phacoemulsification.",2020,"In Group ""A"" 0.5% patients had pain, foreign body sensation and photophobia at 6 weeks whereas in Group ""B"" patients 5% had pain, 1.5% had foreign body sensation,1% had photophobia and 0.5% had watering.
",['study400 consecutive patients of cataract were randomized into two groups consisting of 200 patients each'],"['placebo', 'Oral Vitamin C', 'oral vitamin C', 'temporal clear corneal phacoemulsification']","['pain, foreign body sensation and photophobia', 'photophobia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation (finding)'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}]",,0.044564,"In Group ""A"" 0.5% patients had pain, foreign body sensation and photophobia at 6 weeks whereas in Group ""B"" patients 5% had pain, 1.5% had foreign body sensation,1% had photophobia and 0.5% had watering.
","[{'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Mohan', 'Affiliation': 'Department Of Ophthalmology, GSVM Medical College , Kanpur, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Sah', 'Affiliation': 'Department Of Ophthalmology, GSVM Medical College , Kanpur, India.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Khattri', 'Affiliation': 'Department Of Ophthalmology, GSVM Medical College , Kanpur, India.'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Ahmad', 'Affiliation': 'Department Of Ophthalmology, GSVM Medical College , Kanpur, India.'}, {'ForeName': 'Surendra Kumar', 'Initials': 'SK', 'LastName': 'Sachan', 'Affiliation': 'Department Of Ophthalmology, GSVM Medical College , Kanpur, India.'}]",Current eye research,['10.1080/02713683.2020.1731831']
1025,31347696,A randomized clinical trial of three prompting systems to teach tact relations.,"Prompts are commonly used during discrete trial teaching for individuals diagnosed with autism spectrum disorder (ASD). Three commonly used prompting systems include constant time delay, most-to-least prompting, and flexible prompt fading. Most of the research demonstrating the effectiveness of these three prompting strategies have been completed through the use of single subject experimental designs. Some within the field of behaviorally based approaches to ASD interventions have called for more randomized clinical trials of these approaches. The purpose of the present study was to compare these 3 prompting systems to teach tact relations for 27 individuals diagnosed with ASD through a randomized clinical trial without a control group with respect to pre-post responding, generalization, sessions to mastery, and responding during teaching. Overall, minimal differences were observed across the 3 systems. The results are discussed with respect to future research and clinical application of the methods evaluated.",2020,"Overall, minimal differences were observed across the 3 systems.","['individuals diagnosed with autism spectrum disorder (ASD', '27 individuals diagnosed with ASD']",[],[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]",[],[],27.0,0.129487,"Overall, minimal differences were observed across the 3 systems.","[{'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Cihon', 'Affiliation': 'Autism Partnership Foundation and Endicott College.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Ferguson', 'Affiliation': 'Autism Partnership Foundation.'}, {'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Leaf', 'Affiliation': 'Autism Partnership Foundation and Endicott College.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Milne', 'Affiliation': 'Autism Partnership Foundation and Endicott College.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Leaf', 'Affiliation': 'Autism Partnership Foundation.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McEachin', 'Affiliation': 'Autism Partnership Foundation.'}]",Journal of applied behavior analysis,['10.1002/jaba.617']
1026,31455710,"Using patient-reported outcomes to manage postoperative symptoms in patients with lung cancer: protocol for a multicentre, randomised controlled trial.","INTRODUCTION


Surgery is one of the primary treatments for lung cancer. The postoperative symptom burden experienced by patients with lung cancer is substantial, seriously delaying their recovery from surgery and impairing their quality of life. Patient-reported outcome (PRO)-based symptom management is increasingly regarded as an optimal model for patient-centred care. Currently, clinical trial-based evidence involving early-phase (immediately after surgery for up to 1 month) symptom management of lung cancer is lacking. We propose a randomised trial to evaluate the effect of a PRO-based symptom-monitoring programme with overthreshold alerts and responses for postoperative recovery in patients with lung cancer.
METHODS AND ANALYSIS


The study will recruit 160 patients with lung cancer from six hospitals. The patients will be randomly allocated to the intervention group or control group in a ratio of 1:1. Patients in the intervention group will receive PRO-based symptom management from the specialists when their reported target symptom (pain, coughing, fatigue, disturbed sleep and shortness of breath) scores reach the preset threshold (score ≥4). Patients in the control group will not generate alerts and will follow the standard procedures for symptom management. All patients will receive symptom assessments via the MD Anderson Symptom Inventory-lung cancer module on the day before surgery, daily after surgery and twice a week after discharge until 4 weeks or the start of postoperative oncological treatment. The primary outcome-mean symptom threshold events-will be compared between the intervention and control group via independent sample Student's t-test.
ETHICS AND DISSEMINATION


The study was approved by the Ethics Committee of Sichuan Cancer Hospital on 22 November 2018 (No. SCCHEC-02-2018-045). This manuscript is based on V.2.0, 9 May 2019 of the protocol. The study results will be disseminated in publications in peer-reviewed journals and presentations at academic conferences.
TRIALS REGISTRATION NUMBER


ChiCTR1900020846.",2019,"The primary outcome-mean symptom threshold events-will be compared between the intervention and control group via independent sample Student's t-test.
","['Sichuan Cancer Hospital on 22 November 2018 (No. SCCHEC-02-2018-045', '160 patients with lung cancer from six hospitals', 'patients with lung cancer']",['PRO-based symptom-monitoring programme'],"['target symptom (pain, coughing, fatigue, disturbed sleep and shortness of breath) scores reach']","[{'cui': 'C0019999', 'cui_str': 'Hospitals, Cancer'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",,0.118784,"The primary outcome-mean symptom threshold events-will be compared between the intervention and control group via independent sample Student's t-test.
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': 'Department of Thoracic Surgery, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Yuanqiang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiothoracic Surgery, Zigong First People's Hospital, Zigong, China.""}, {'ForeName': 'Wenhong', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': ""Department of Thoracic and Cardiovascular Surgery, Jiangyou People's Hospital, Jiangyou, China.""}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liao', 'Affiliation': ""Department of Cardiothoracic Surgical Oncology, Dazhu County People's Hospital, Dazhu County, China.""}, {'ForeName': 'Yunfei', 'Initials': 'Y', 'LastName': 'Mu', 'Affiliation': ""Department of Thoracic Surgery, The Third People's Hospital of Chengdu, Chengdu, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Department of Thoracic Surgery, The Seventh People's Hospital of Chengdu, Chengdu, China.""}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Thoracic Surgery, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Chuanmei', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Department of Thoracic Surgery, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China qshi@mdanderson.org liqiang@sichuancancer.org.'}, {'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA qshi@mdanderson.org liqiang@sichuancancer.org.'}]",BMJ open,['10.1136/bmjopen-2019-030041']
1027,31364427,Examining Recidivism in a Prostitution Diversion Program.,"Street-based sex work is criminalized throughout much of the U.S. Diversion programs have shown mixed results. This study examined the effect a quasi-experimental intervention (prostitution diversion program,  n  = 149) had on prostitution rearrest compared with a waitlist control group ( n  = 77) among  N  = 226 individuals arrested for prostitution in Baltimore. In both groups,  n  = 64 (28.32%) were rearrested for prostitution over 30 months. Tests of differences compared groups with a significant difference in gender only. A Cox proportional hazard model examined differences in survival time (to recidivist prostitution arrest) between individuals in the control and intervention groups at 6, 12, 18, 24, and 30 months. Results indicate that participation in the intervention did not have a significant effect on decreasing prostitution arrests over time. History of prior prostitution arrest was a significant predictor (hazard ration [HR] = 1.12,  p  = .02) of rearrest.Lack of program success suggests that barriers to exiting prostitution are substantial, despite availability of supportive services, and that diversion programs may not be the best intervention strategy for all sex workers. Future research should identify motivators for exiting and how to reduce exiting barriers.",2020,"History of prior prostitution arrest was a significant predictor (hazard ration (HR) = 1.12,  p  = .02) of rearrest.",['group ( n  = 77) among  N  = 226 individuals arrested for prostitution in Baltimore'],"['quasi-experimental intervention (prostitution diversion program,  n  = 149) had on prostitution rearrest compared with a waitlist control']",['survival time'],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C0033595', 'cui_str': 'Sex Industry'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}]","[{'cui': 'C0033595', 'cui_str': 'Sex Industry'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2919552', 'cui_str': 'Survival time'}]",226.0,0.017345,"History of prior prostitution arrest was a significant predictor (hazard ration (HR) = 1.12,  p  = .02) of rearrest.","[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Koegler', 'Affiliation': 'University of Missouri-St. Louis, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Preble', 'Affiliation': 'University of Missouri-Columbia, USA.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Cimino', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Stevens', 'Affiliation': 'University of Missouri-Columbia, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Diehl', 'Affiliation': ''}]",International journal of offender therapy and comparative criminology,['10.1177/0306624X19866115']
1028,32430395,Thrombolysis with alteplase 3-4.5 hours after acute ischaemic stroke: trial reanalysis adjusted for baseline imbalances.,"OBJECTIVES


Alteplase is commonly recommended for acute ischaemic stroke within 4.5 hours after stroke onset. The Third European Cooperative Acute Stroke Study (ECASS III) is the only trial reporting statistically significant efficacy for clinical outcomes for alteplase use 3-4.5 hours after stroke onset. However, baseline imbalances in history of prior stroke and stroke severity score may confound this apparent finding of efficacy. We reanalysed the ECASS III trial data adjusting for baseline imbalances to determine the robustness or sensitivity of the efficacy estimates.
DESIGN


Reanalysis of randomised placebo-controlled trial. We obtained access to the ECASS III trial data and replicated the previously reported analyses to confirm our understanding of the data. We adjusted for baseline imbalances using multivariable analyses and stratified analyses and performed sensitivity analysis for missing data.
SETTING


Emergency care.
PARTICIPANTS


821 adults with acute ischaemic stroke who could be treated 3-4.5 hours after symptom onset.
INTERVENTIONS


Intravenous alteplase (0.9 mg/kg of body weight) or placebo.
MAIN OUTCOME MEASURES


The original primary efficacy outcome was modified Rankin Scale (mRS) score 0 or 1 (ie, being alive without any disability) and the original secondary efficacy outcome was a global outcome based on a composite of functional end points, both at 90 days. Adjusted analyses were only reported for the primary efficacy outcome and the original study protocol did not specify methods for adjusted analyses. Our adjusted reanalysis included these outcomes, symptom-free status (mRS 0), dependence-free status (mRS 0-2), mortality (mRS 6) and change across the mRS 0-6 spectrum at 90 days; and mortality and symptomatic intracranial haemorrhage at 7 days.
RESULTS


We replicated previously reported unadjusted analyses but discovered they were based on a modified interpretation of the National Institutes of Health Stroke Scale (NIHSS) score. The secondary efficacy outcome was no longer significant using the original NIHSS score. Previously reported adjusted analyses could only be replicated with significant effects for the primary efficacy outcome by using statistical approaches not reported in the trial protocol or statistical analysis plan. In analyses adjusting for baseline imbalances, all efficacy outcomes were not significant, but increases in symptomatic intracranial haemorrhage remained significant.
CONCLUSIONS


Reanalysis of the ECASS III trial data with multiple approaches adjusting for baseline imbalances does not support any significant benefits and continues to support harms for the use of alteplase 3-4.5 hours after stroke onset. Clinicians, patients and policymakers should reconsider interpretations and decisions regarding management of acute ischaemic stroke that were based on ECASS III results.
TRIAL REGISTRATION NUMBER


NCT00153036.",2020,"In analyses adjusting for baseline imbalances, all efficacy outcomes were not significant, but increases in symptomatic intracranial haemorrhage remained significant.
","['Emergency care', '821 adults with acute ischaemic stroke who could be treated 3-4.5\u2009hours after symptom onset']","['Intravenous alteplase', 'placebo']","['original NIHSS score', 'Health Stroke Scale (NIHSS) score', 'symptomatic intracranial haemorrhage', 'modified Rankin Scale (mRS) score 0 or 1 (ie, being alive without any disability', 'symptom-free status (mRS 0), dependence-free status (mRS 0-2), mortality (mRS 6) and change across the mRS 0-6 spectrum at 90 days; and mortality and symptomatic intracranial haemorrhage']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0436342', 'cui_str': 'Free of symptoms'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",821.0,0.293191,"In analyses adjusting for baseline imbalances, all efficacy outcomes were not significant, but increases in symptomatic intracranial haemorrhage remained significant.
","[{'ForeName': 'Brian Scott', 'Initials': 'BS', 'LastName': 'Alper', 'Affiliation': 'Medical Knowledge Office, EBSCO Information Services, Ipswich, Massachusetts, USA balper@ebsco.com.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Foster', 'Affiliation': ""Biostatistics, St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': ""Biostatistics, St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rae-Grant', 'Affiliation': 'DynaMed, EBSCO Health, Ipswich, Massachusetts, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Malone-Moses', 'Affiliation': 'Innovations and Evidence-Based Medicine Development, EBSCO Health, Ipswich, Massachusetts, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Manheimer', 'Affiliation': 'Innovations and Evidence-Based Medicine Development, EBSCO Health, Ipswich, Massachusetts, USA.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2020-111386']
1029,20420270,Increasing the dosage of progesterone (P) supplemention from the mid-luteal phase in women not attaining a mid-luteal homogeneous hyperechogenic (HH) pattern with sonography improves pregnancy rates (PRS) following frozen embryo transfer (ET).,"PURPOSE


To determine if a mid-luteal phase non-homogeneous hyperechogenic (HH) endometrial echo pattern may lower pregnancy rates following frozen embryo transfer and to determine if raising the dosage of progesterone improves pregnancy outcome.
METHODS


Women not attaining an HH pattern at the mid-luteal phase following estrogen-progesterone replacement were randomly given (or not) an increase in progesterone dosage.
RESULTS


Increasing the progesterone dosage in those not attaining an HH pattern significantly improved the pregnancy rate relative to controls not attaining an HH pattern and showed a trend for higher pregnancy rates than those with an HH pattern.
CONCLUSIONS


The mid-luteal phase echo pattern should be evaluated for a non-HH pattern so that an increase in progesterone dosage could be provided possibly resulting in higher pregnancy rates.",2010,"Increasing the progesterone dosage in those not attaining an HH pattern significantly improved the pregnancy rate relative to controls not attaining an HH pattern and showed a trend for higher pregnancy rates than those with an HH pattern.
",[],"['progesterone', 'progesterone (P) supplemention', 'estrogen-progesterone replacement']","['pregnancy rates (PRS', 'pregnancy rate relative', 'pregnancy rates']",[],"[{'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",,0.0214452,"Increasing the progesterone dosage in those not attaining an HH pattern significantly improved the pregnancy rate relative to controls not attaining an HH pattern and showed a trend for higher pregnancy rates than those with an HH pattern.
","[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Check', 'Affiliation': 'The University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School at Camden, Cooper Hospital/University Medical Center, Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology & Infertility, Camden, NJ, USA. laurie@ccivf.com'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dietterich', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Choe', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Amui', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brasile', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1030,20420283,Dinoprostone vaginal insert versus intravenous oxytocin to reduce postpartum blood loss following vaginal or cesarean delivery.,"OBJECTIVE


To compare the impact of a dinoprostone vaginal insert and intravenous oxytocin in reducing blood loss of women undergoing vaginal or cesarean delivery.
METHODS


This study was conducted among term singleton pregnancies delivered vaginally or by elective cesarean section. In the vaginally delivered cases, active management of the third stage of labor was conducted. During cesarean delivery, 20 IU of intravenous oxytocin was administered. Women, who either delivered via the vaginal or abdominal route, were then randomly allocated to receive 10 mg vaginal dinoprostone insert for 12 hours (group I, n: 100) or intravenous oxytocin (group II, n: 100), respectively.
RESULTS


Mean blood loss and need for additional uterotonics and postpartum hemoglobin and hematocrit levels at 24 and 36 hours after delivery did not differ between the two groups. Women allocated to the dinoprostone vaginal insert arm experienced more nausea and vomiting.
CONCLUSION


Dinoprostone vaginal insert was as effective as intravenous oxytocin in the prevention of postpartum blood loss.",2010,"RESULTS


Mean blood loss and need for additional uterotonics and postpartum hemoglobin and hematocrit levels at 24 and 36 hours after delivery did not differ between the two groups.","['women undergoing vaginal or cesarean delivery', 'term singleton pregnancies delivered vaginally or by elective cesarean section', 'vaginal or cesarean delivery', 'Women, who either delivered via the vaginal or abdominal route']","['oxytocin', 'Dinoprostone vaginal insert versus intravenous oxytocin', 'dinoprostone vaginal insert and intravenous oxytocin', 'dinoprostone', 'vaginal dinoprostone', 'intravenous oxytocin', 'Dinoprostone']","['postpartum blood loss', 'blood loss', 'Mean blood loss and need for additional uterotonics and postpartum hemoglobin and hematocrit levels', 'nausea and vomiting']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C1719963', 'cui_str': 'Conventional release vaginal insert'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C3653843', 'cui_str': 'Other uterotonics in ATC'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}]",,0.0772064,"RESULTS


Mean blood loss and need for additional uterotonics and postpartum hemoglobin and hematocrit levels at 24 and 36 hours after delivery did not differ between the two groups.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ozalp', 'Affiliation': 'Department of Obstetrics and Gynecology, Perinatology Unit, Eskisehir Osmangazi University School of Medicine, Meselik Kampusu, Eskisehir, Turkey.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Tanir', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sener', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1031,31837916,Depth of neuromuscular blockade and the perioperative conditions in laparoscopic surgery in pediatric population: Randomized controlled pilot trial.,,2020,,['pediatric population'],['laparoscopic surgery'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}]",[],,0.431689,,"[{'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Klucka', 'Affiliation': 'Department of Pediatric Anesthesia and Intensive Care, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic; Faculty of Medicine, Masaryk University Brno, Kamenice 3, Brno 625 00, Czech Republic.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Szturzova', 'Affiliation': 'Department of Pediatric Anesthesia and Intensive Care, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kosinova', 'Affiliation': 'Department of Pediatric Anesthesia and Intensive Care, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic; Faculty of Medicine, Masaryk University Brno, Kamenice 3, Brno 625 00, Czech Republic. Electronic address: mata.kosinova@gmail.com.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Knoppova', 'Affiliation': 'Department of Pediatric Anesthesia and Intensive Care, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Toukalkova', 'Affiliation': 'Department of Pediatric Anesthesia and Intensive Care, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic; Faculty of Medicine, Masaryk University Brno, Kamenice 3, Brno 625 00, Czech Republic.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Stoudek', 'Affiliation': 'Department of Pediatric Anesthesia and Intensive Care, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic; Faculty of Medicine, Masaryk University Brno, Kamenice 3, Brno 625 00, Czech Republic.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Kratochvil', 'Affiliation': 'Department of Pediatric Anesthesia and Intensive Care, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic; Faculty of Medicine, Masaryk University Brno, Kamenice 3, Brno 625 00, Czech Republic.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Trckova', 'Affiliation': 'Department of Pediatric Anesthesia and Intensive Care, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Klincova', 'Affiliation': 'Department of Pediatric Anesthesia and Intensive Care, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic; Faculty of Medicine, Masaryk University Brno, Kamenice 3, Brno 625 00, Czech Republic.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Kovalcikova', 'Affiliation': 'Faculty of Medicine, Masaryk University Brno, Kamenice 3, Brno 625 00, Czech Republic; Institute of Biostatistics and Bioanalyses, Faculty of Medicine, Masaryk University, Kamenice 3, Brno 625 00, Czech Republic.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Pavlik', 'Affiliation': 'Faculty of Medicine, Masaryk University Brno, Kamenice 3, Brno 625 00, Czech Republic; Institute of Biostatistics and Bioanalyses, Faculty of Medicine, Masaryk University, Kamenice 3, Brno 625 00, Czech Republic.'}, {'ForeName': 'Ladislav', 'Initials': 'L', 'LastName': 'Planka', 'Affiliation': 'Faculty of Medicine, Masaryk University Brno, Kamenice 3, Brno 625 00, Czech Republic; Department of Pediatric Surgery, Orthopedic and Traumatology, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Tuma', 'Affiliation': 'Faculty of Medicine, Masaryk University Brno, Kamenice 3, Brno 625 00, Czech Republic; Department of Pediatric Surgery, Orthopedic and Traumatology, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Stourac', 'Affiliation': 'Department of Pediatric Anesthesia and Intensive Care, University Hospital Brno, Jihlavská 20, Brno 625 00, Czech Republic; Faculty of Medicine, Masaryk University Brno, Kamenice 3, Brno 625 00, Czech Republic.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.109659']
1032,19964483,An investigation on the effects of single pulse transcranial magnetic stimulation in a modified maximum entropy auditory stimulation paradigm.,"In this paper, we intend to investigate further the effects of single pulse TMS (sTMS) on auditory attention through an experimental design that combines a modified version of maximum entropy stimulation paradigm. Single pulses of TMS with 4.4s inter-stimulus interval (ISI) were applied to the left temporal lobe of subjects while three randomized auditory stimuli with constant ISI of 1.1s were delivered to the contralateral side within the TMS stimulation duration. Our main focus was to examine the time course of the auditory late responses (ALRs) due to TMS stimulation by a phase clustering on the unit circle measure and an adaptive shift- invariant feature extraction method. In the attention scheme, a significant difference in the phase stability between TMS and no-TMS was found in the range of the N1 wave of ALRs. However, the difference occurs only for the data after 1.1s. Furthermore, there is an absence of differences in the amplitude of the ALR. In addition, the effects of TMS and attention can also be discriminated very well and illuminate the effects of TMS in auditory attention. It is concluded that even sTMS might have the potential to alter the attentional states and the effects can last about 1s, at least when considering the large- scale neural correlates of attention in ALR sequences.",2009,"It is concluded that even sTMS might have the potential to alter the attentional states and the effects can last about 1s, at least when considering the large- scale neural correlates of attention in ALR sequences.",[],"['TMS', 'single pulse transcranial magnetic stimulation', 'single pulse TMS (sTMS']",['phase stability between TMS and no-TMS'],[],"[{'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}]","[{'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",,0.0270598,"It is concluded that even sTMS might have the potential to alter the attentional states and the effects can last about 1s, at least when considering the large- scale neural correlates of attention in ALR sequences.","[{'ForeName': 'Yin Fen', 'Initials': 'YF', 'LastName': 'Low', 'Affiliation': 'Computational Diagnostics and Biocybernetics Unit at Saarland University Hospital and Saarland University of Applied Sciences, Homburg/Saarbruecken, Germany. yinfen@cdb-unit.de'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Schwerdtfeger', 'Affiliation': ''}, {'ForeName': 'Arief R', 'Initials': 'AR', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Strauss', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2009.5334066']
1033,19964499,Therapist-mediated post-stroke rehabilitation using haptic/graphic error augmentation.,"Recent research has suggested that enhanced retraining for stroke patients using haptics (robotic forces) and graphics (visual display) to generate a practice environment that can artificially enhance error rather than reducing it, can stimulate new learning and foster accelerated recovery. We present an evaluation of early results of this novel post-stroke robotic-aided therapy trial that incorporates these ideas in a large VR system and simultaneously employs the patient, the therapist, and the technology to accomplish effective therapy.",2009,"Recent research has suggested that enhanced retraining for stroke patients using haptics (robotic forces) and graphics (visual display) to generate a practice environment that can artificially enhance error rather than reducing it, can stimulate new learning and foster accelerated recovery.",[],['Therapist-mediated post-stroke rehabilitation using haptic/graphic error augmentation'],[],[],"[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]",[],,0.0343917,"Recent research has suggested that enhanced retraining for stroke patients using haptics (robotic forces) and graphics (visual display) to generate a practice environment that can artificially enhance error rather than reducing it, can stimulate new learning and foster accelerated recovery.","[{'ForeName': 'Sylvester Vijay', 'Initials': 'SV', 'LastName': 'Rozario', 'Affiliation': 'University of Illinois at Chicago, Illinois 60607, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Housman', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kovic', 'Affiliation': ''}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': 'Kenyon', 'Affiliation': ''}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Patton', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2009.5333875']
1034,31455199,Approximate confidence limit for the reference scaled bioequivalence with a parallel design.,"The reference scaled bioequivalence has been proposed with many successful applications for the highly variable products. The statistical properties for the reference scaled bioequivalence have been studied for the commonly used crossover design. However, a crossover design may not be feasible in a real application such as the biosimilar study, instead a parallel design is a more timely and cost-effective choice. In this paper, the approximate upper confidence interval limit for the linearized criteria in the reference scaled bioequivalence from a parallel design is derived. The performance of the approximation is evaluated through the simulation. The simulation results show that this approximation performs well and gives reasonable power and well-controlled type I error.",2020,The simulation results show that this approximation performs well and gives reasonable power and well-controlled type I error.,[],[],[],[],[],[],,0.0387668,The simulation results show that this approximation performs well and gives reasonable power and well-controlled type I error.,"[{'ForeName': 'Jason J Z', 'Initials': 'JJZ', 'LastName': 'Liao', 'Affiliation': 'Biostatistics and Research Decision Sciences, Merck & Co., Inc, North Wales, PA, USA.'}, {'ForeName': 'Yifang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Early Development Biostatistics, Novartis Pharmaceuticals Corporation, Cambridge, MA, USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2019.1657438']
1035,32129558,Validation of the Australian Treatment Outcomes Profile for use in clients with cannabis dependence.,"INTRODUCTION AND AIMS


The Australian Treatment Outcomes Profile (ATOP) was developed as a clinical tool for monitoring the substance use, health and wellbeing of clients in alcohol and other drug treatment. This is the first psychometric validation of the ATOP in a cannabis-dependent treatment population.
DESIGN AND METHODS


A total of 128 individuals with cannabis dependence enrolled in an outpatient randomised controlled trial were administered the ATOP and gold-standard health and wellbeing questionnaires once by clinicians and once by researchers at baseline. Concurrent validity was assessed by testing ATOP Psychological Health, Physical Health and Quality of Life questions against concurrently administered gold-standard questionnaires: the Short Form 36 Health Survey (SF-36), the 21-item Depression, Anxiety and Stress Scale (DASS-21) and the Sheehan Disability Scale (SDS). Interrater reliability was tested by comparing clinician-administered ATOP items at the medical screening interview to the same ATOP items administered by researchers at baseline.
RESULTS


ATOP Psychological Health showed moderate to strong correlations with SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores (r = 0.40-0.52) and ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores (r = 0.36-0.67). The ATOP Quality of Life scale showed moderate agreement with the SDS and six-dimensional health state short form scales (r = 0.38-0.40). ATOP substance use, employment, education and child care items showed good to excellent interrater reliability (Krippendorff's α = 0.62-0.81), and tobacco use, Psychological Health, Physical Health and Quality of Life showed fair to moderate interrater reliability (Krippendorff's α = 0.42-0.53).
DISCUSSION AND CONCLUSIONS


The ATOP appears to be valid and reliable when tested in a population with cannabis-dependence, justifying its widespread use in clinical settings.",2020,"RESULTS


ATOP Psychological Health showed moderate to strong correlations with SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores (r = 0.40-0.52) and ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores (r = 0.36-0.67).","['128 individuals with cannabis dependence enrolled', 'clients with cannabis dependence']",['ATOP and gold-standard health and wellbeing questionnaires once by clinicians and once by researchers at baseline'],"['tobacco use, Psychological Health, Physical Health and Quality of Life', 'ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores', 'SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores', 'testing ATOP Psychological Health, Physical Health and Quality of Life questions against concurrently administered gold-standard questionnaires: the Short Form 36 Health Survey (SF-36), the 21-item Depression, Anxiety and Stress Scale (DASS-21) and the Sheehan Disability Scale (SDS', 'substance use, health and wellbeing of clients in alcohol', 'ATOP Quality of Life scale', 'Interrater reliability']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0006870', 'cui_str': 'Cannabis Dependence'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]","[{'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]","[{'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",128.0,0.0326362,"RESULTS


ATOP Psychological Health showed moderate to strong correlations with SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores (r = 0.40-0.52) and ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores (r = 0.36-0.67).","[{'ForeName': 'Llewellyn', 'Initials': 'L', 'LastName': 'Mills', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'School of Medicine, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Montebello', 'Affiliation': 'Discipline of Addiction Medicine, Faculty Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network, Sydney, Australia.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Deacon', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Copeland', 'Affiliation': 'Mind and Neuroscience Thompson Institute, University of the Sunshine Coast, Sunshine Coast, Australia.'}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Jefferies', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network, Sydney, Australia.'}, {'ForeName': 'Consuelo', 'Initials': 'C', 'LastName': 'Rivas', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Mammen', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, Australia.'}]",Drug and alcohol review,['10.1111/dar.13050']
1036,28810477,Feasibility randomised controlled trial of a self-help acceptance and commitment therapy intervention for grief and psychological distress in carers of palliative care patients.,"We tested the feasibility and preliminary effectiveness of an acceptance and commitment therapy self-help intervention for grief and psychological distress in carers of patients in palliative care. Carers were randomised to the control group, which received treatment as usual, or the intervention group, which received treatment as usual plus an acceptance and commitment therapy-based self-help booklet and telephone support call. Questionnaires were completed at baseline, 1-month post-allocation and 6 months post-loss. Results indicated that the intervention was generally feasible and viewed as acceptable to carers. Preliminary effectiveness analyses showed at least a small effect in acceptance, valued-living, grief and psychological distress.",2020,We tested the feasibility and preliminary effectiveness of an acceptance and commitment therapy self-help intervention for grief and psychological distress in carers of patients in palliative care.,"['carers of palliative care patients', 'carers of patients in palliative care']","['self-help acceptance and commitment therapy intervention', 'acceptance and commitment therapy self-help intervention', 'usual plus an acceptance and commitment therapy-based self-help booklet and telephone support call']","['acceptance, valued-living, grief and psychological distress', 'grief and psychological distress']","[{'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.105841,We tested the feasibility and preliminary effectiveness of an acceptance and commitment therapy self-help intervention for grief and psychological distress in carers of patients in palliative care.,"[{'ForeName': 'Esther L', 'Initials': 'EL', 'LastName': 'Davis', 'Affiliation': 'University of Wollongong, Australia.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Deane', 'Affiliation': 'University of Wollongong, Australia.'}, {'ForeName': 'Geoffrey Cb', 'Initials': 'GC', 'LastName': 'Lyons', 'Affiliation': 'Australian College of Applied Psychology, Australia.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Barclay', 'Affiliation': 'University of Wollongong, Australia.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bourne', 'Affiliation': 'Illawarra Shoalhaven Local Health District, Australia.'}, {'ForeName': 'Vivienne', 'Initials': 'V', 'LastName': 'Connolly', 'Affiliation': 'Illawarra Shoalhaven Local Health District, Australia.'}]",Journal of health psychology,['10.1177/1359105317715091']
1037,31375316,Personal and social adjustment effects of roluperidone in patients with schizophrenia and negative symptoms: Results from an exploratory outcome of a randomized placebo-controlled trial.,,2019,,['patients with schizophrenia and negative symptoms'],"['placebo', 'roluperidone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.224684,,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rabinowitz', 'Affiliation': 'Bar Ilan University, Ramat Gan, Israel. Electronic address: jonathan.rabinowitz@biu.ac.il.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Badescu', 'Affiliation': 'Neuropsychiatric Hospital Craiova, Romania.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Palamarchuk', 'Affiliation': 'Kherson Regional Psychiatric Hospital, Ukraine.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Filyk', 'Affiliation': 'Kharkiv Railway Clinical Hospital #1, Ukraine.'}, {'ForeName': 'Anatolii', 'Initials': 'A', 'LastName': 'Voloshchuk', 'Affiliation': 'Odesa Regional Medical Centre of Mental Health, Ukraine.'}, {'ForeName': 'Vadym', 'Initials': 'V', 'LastName': 'Rud', 'Affiliation': 'Poltava Regional Clinical Psychiatry Hospital, Ukraine.'}, {'ForeName': 'Ellina', 'Initials': 'E', 'LastName': 'Melnyk', 'Affiliation': 'Odesa Regional Medical Centre of Mental Health, Ukraine.'}, {'ForeName': 'Andrii', 'Initials': 'A', 'LastName': 'Skrypnikov', 'Affiliation': 'Ukrainian Medical Stomatological Academy, Dept. of Psychiatry, Ukraine.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Minerva Neurosciences, 1601 Trapelo Road, Suite 286, Waltham, MA 02451, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Saoud', 'Affiliation': 'Minerva Neurosciences, 1601 Trapelo Road, Suite 286, Waltham, MA 02451, USA.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Luthringer', 'Affiliation': 'Minerva Neurosciences, 1601 Trapelo Road, Suite 286, Waltham, MA 02451, USA.'}]",Schizophrenia research,['10.1016/j.schres.2019.07.029']
1038,32430507,Impact of Myc in HIV-associated non-Hodgkin lymphomas treated with EPOCH and outcomes with vorinostat (AMC-075 trial).,"EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) is a preferred regimen for HIV-non-Hodgkin lymphomas (HIV-NHLs), which are frequently Epstein-Barr virus (EBV) positive or human herpesvirus type-8 (HHV-8) positive. The histone deacetylase (HDAC) inhibitor vorinostat disrupts EBV/HHV-8 latency, enhances chemotherapy-induced cell death, and may clear HIV reservoirs. We performed a randomized phase 2 study in 90 patients (45 per study arm) with aggressive HIV-NHLs, using dose-adjusted EPOCH (plus rituximab if CD20+), alone or with 300 mg vorinostat, administered on days 1 to 5 of each cycle. Up to 1 prior cycle of systemic chemotherapy was allowed. The primary end point was complete response (CR). In 86 evaluable patients with diffuse large B-cell lymphoma (DLBCL; n = 61), plasmablastic lymphoma (n = 15), primary effusion lymphoma (n = 7), unclassifiable B-cell NHL (n = 2), and Burkitt lymphoma (n = 1), CR rates were 74% vs 68% for EPOCH vs EPOCH-vorinostat (P = .72). Patients with a CD4+ count <200 cells/mm3 had a lower CR rate. EPOCH-vorinostat did not eliminate HIV reservoirs, resulted in more frequent grade 4 neutropenia and thrombocytopenia, and did not affect survival. Overall, patients with Myc+ DLBCL had a significantly lower EFS. A low diagnosis-to-treatment interval (DTI) was also associated with inferior outcomes, whereas preprotocol therapy had no negative impact. In summary, EPOCH had broad efficacy against highly aggressive HIV-NHLs, whereas vorinostat had no benefit; patients with Myc-driven DLBCL, low CD4, and low DTI had less favorable outcomes. Permitting preprotocol therapy facilitated accruals without compromising outcomes. This trial was registered at www.clinicaltrials.gov as #NCT0119384.",2020,The overall and event-free survival (EFS) rates were similar between arms.,"['86 evaluable patients with diffuse large B-cell lymphoma (n=61), plasmablastic lymphoma (n=15), primary effusion lymphoma (n=7), unclassifiable B-cell NHL (n=2), and Burkitt lymphoma (n=1', '90 patients (45 per arm) with aggressive HIV-NHLs using dose']",['adjusted EPOCH (plus rituximab if CD20+) alone or with vorinostat 300 mg administered on days 1-5 of each cycle'],"['CR rates', 'EPOCH efficacy', 'complete response (CR', 'Low diagnosis-to-treatment interval (DTI', 'EFS', 'overall and event-free survival (EFS) rates', 'and/or HIV clearance', 'frequent grade 4 neutropenia and thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0079746', 'cui_str': ""Diffuse non-Hodgkin's lymphoma, immunoblastic (clinical)""}, {'cui': 'C1292753', 'cui_str': 'Primary effusion lymphoma'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",90.0,0.175059,The overall and event-free survival (EFS) rates were similar between arms.,"[{'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Ramos', 'Affiliation': 'Department of Medicine, University of Miami School of Medicine, Miami, FL.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Department of Oncology, Albert Einstein Comprehensive Cancer Center, Bronx, NY.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Weill Medical College of Cornell University, New York, NY.'}, {'ForeName': 'Erin G', 'Initials': 'EG', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ambinder', 'Affiliation': 'Department of Oncology, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Siegel', 'Affiliation': 'Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Page C', 'Initials': 'PC', 'LastName': 'Moore', 'Affiliation': 'Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Rubinstein', 'Affiliation': 'Section of Hematology/Oncology, John H. Stroger Jr Hospital of Cook County, Chicago, IL.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Durand', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': 'Cesarman', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Weill Medical College of Cornell University, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aboulafia', 'Affiliation': 'Division of Hematology and Oncology, Virginia Mason Medical Center, Seattle, WA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Internal Medicine, Ohio State University, Columbus, OH.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Ratner', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Kaplan', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Capoferri', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Jeannette Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Mitsuyasu', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Noy', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY; and.'}]",Blood,['10.1182/blood.2019003959']
1039,31706739,Is preoperative forced-air warming effective in the prevention of hypothermia in orthopedic surgical patients? A randomized controlled trial.,,2020,,['orthopedic surgical patients'],[],[],"[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.123345,,"[{'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Thiel', 'Affiliation': 'Department of Anesthesiology, OLVG Hospital, Amsterdam, the Netherlands. Electronic address: b.thiel@olvg.nl.'}, {'ForeName': 'Bart C', 'Initials': 'BC', 'LastName': 'Mooijer', 'Affiliation': 'Department of Anesthesiology, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Kolff-Gart', 'Affiliation': 'Department of Anesthesiology, OLVG Hospital, Amsterdam, the Netherlands; Department of Radiology, Spaarne Gasthuis, Hoofddorp, the Netherlands.'}, {'ForeName': 'Bojana Milojkovic', 'Initials': 'BM', 'LastName': 'Kerklaan', 'Affiliation': ""Department of Anesthesiology, OLVG Hospital, Amsterdam, the Netherlands; Medical Center Dupont, 's Heeren Loo, Ermelo, the Netherlands.""}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Department of Orthopedic Surgery, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Haan', 'Affiliation': 'Department of Anesthesiology, OLVG Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Muriel A M', 'Initials': 'MAM', 'LastName': 'Siepel', 'Affiliation': 'Department of Anesthesiology, OLVG Hospital, Amsterdam, the Netherlands.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.109633']
1040,19965029,Effect of remifentanil on the nonlinear electroencephalographic entropy parameters in propofol anesthesia.,"Nonlinear electroencephalographic entropy parameters have been proposed for the assessment of depth of anesthesia. The influence of remifentanil, a commonly used intraoperative opioid, on these parameters, namely approximate entropy (ApEn), sample entropy (SampEn), and permutation entropy (PeEn), during induction of propofol anesthesia was studied. Remifentanil was shown to reduce the propofol-induced changes in ApEn and SampEn throughout the transition from awake to burst suppression state. Coadministration of opioids therefore challenges the reliability of these parameters as indicators of depth of anesthesia. No consistent influence on PeEn was observed. However, this may have been due to strong interindividual variation in PeEn values.",2009,Remifentanil was shown to reduce the propofol-induced changes in ApEn and SampEn throughout the transition from awake to burst suppression state.,['propofol anesthesia'],"['Remifentanil', 'remifentanil']","['PeEn', 'namely approximate entropy (ApEn), sample entropy (SampEn), and permutation entropy (PeEn', 'nonlinear electroencephalographic entropy parameters']","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.028866,Remifentanil was shown to reduce the propofol-induced changes in ApEn and SampEn throughout the transition from awake to burst suppression state.,"[{'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Kortelainen', 'Affiliation': 'Department of Electrical and Information Engineering, FIN-90014 University of Oulu, Finland. jukka.kortelainen@ee.oulu.fi'}, {'ForeName': 'Miika', 'Initials': 'M', 'LastName': 'Koskinen', 'Affiliation': ''}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Mustola', 'Affiliation': ''}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Seppanen', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2009.5334612']
1041,19965037,Technical and compliance considerations for mobile health self-monitoring of glucose and blood pressure for patients with diabetes.,"Self-monitoring of blood glucose is an integral part of diabetes care which may be extended to other biometrics. Cellular and short range communication technologies will be important for the routine usage of these systems. However, the issues of follow-up and patient compliance with these emerging systems have not been yet studied evaluated but could be critical to the adoption of these technologies. We evaluated the impact of mobile telemonitoring on the intensification of care on blood pressure control and exposure to hyperglycaemia in patients with diabetes. We randomised 137 patients with diabetes to either mobile telemonitoring (n = 72) or usual care patients (n = 65) for 9 months. In this paper we present some of the clinical results with focus on blood pressure control hypertension and highlight some of the technical and compliance issues that were encountered.",2009,We evaluated the impact of mobile telemonitoring on the intensification of care on blood pressure control and exposure to hyperglycaemia in patients with diabetes.,"['patients with diabetes', '137 patients with diabetes to either mobile telemonitoring (n = 72) or usual care patients (n = 65) for 9 months']",['Self-monitoring of blood glucose'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}]",[],137.0,0.0137331,We evaluated the impact of mobile telemonitoring on the intensification of care on blood pressure control and exposure to hyperglycaemia in patients with diabetes.,"[{'ForeName': 'Robert S H', 'Initials': 'RS', 'LastName': 'Istepanian', 'Affiliation': 'Mobile Information and Network Technology Research Centre, Kingston University London. r.istepanian@kingston.ac.uk'}, {'ForeName': 'Ala', 'Initials': 'A', 'LastName': 'Sungoor', 'Affiliation': ''}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Earle', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2009.5334580']
1042,19965253,A clinical study of motor imagery-based brain-computer interface for upper limb robotic rehabilitation.,"Non-invasive EEG-based motor imagery brain-computer interface (MI-BCI) holds promise to effectively restore motor control to stroke survivors. This clinical study investigates the effects of MI-BCI for upper limb robotic rehabilitation compared to standard robotic rehabilitation. The subjects are hemiparetic stroke patients with mean age of 50.2 and baseline Fugl-Meyer (FM) score 29.7 (out of 66, higher = better) randomly assigned to each group respectively (N = 8 and 10). Each subject underwent 12 sessions of 1-hour rehabilitation for 4 weeks. Significant gains in FM scores were observed in both groups at post-rehabilitation (4.9, p = 0.001) and 2-month post-rehabilitation (4.9, p = 0.002). The experimental group yielded higher 2-month post-rehabilitation gain than the control (6.0 versus 4.0) but no significance was found (p = 0.475). However, among subjects with positive gain (N = 6 and 7), the initial difference of 2.8 between the two groups was increased to a significant 6.5 (p = 0.019) after adjustment for age and gender. Hence this study provides evidence that BCI-driven robotic rehabilitation is effective in restoring motor control for stroke.",2009,"Significant gains in FM scores were observed in both groups at post-rehabilitation (4.9, p = 0.001) and 2-month post-rehabilitation (4.9, p = 0.002).","['subjects are hemiparetic stroke patients with mean age of 50.2 and baseline Fugl-Meyer (FM) score 29.7 (out of 66, higher = better) randomly assigned to each group respectively (N = 8 and 10', 'upper limb robotic rehabilitation']","['invasive EEG-based motor imagery brain-computer interface (MI-BCI', 'motor imagery-based brain-computer interface', 'BCI-driven robotic rehabilitation', 'MI-BCI', 'standard robotic rehabilitation']","['FM scores', '2-month post-rehabilitation gain']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interfaces'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]",66.0,0.0271349,"Significant gains in FM scores were observed in both groups at post-rehabilitation (4.9, p = 0.001) and 2-month post-rehabilitation (4.9, p = 0.002).","[{'ForeName': 'Kai Keng', 'Initials': 'KK', 'LastName': 'Ang', 'Affiliation': 'Institute for Infocomm Research, Agency for Science, Technology and Research, 21 Heng Mui Keng Terrace, Singapore. kkang@i2r.astar.edu.sg'}, {'ForeName': 'Cuntai', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': ''}, {'ForeName': 'Karen Sui Geok', 'Initials': 'KS', 'LastName': 'Chua', 'Affiliation': ''}, {'ForeName': 'Beng Ti', 'Initials': 'BT', 'LastName': 'Ang', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kuah', 'Affiliation': ''}, {'ForeName': 'Chuanchu', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Kok Soon', 'Initials': 'KS', 'LastName': 'Phua', 'Affiliation': ''}, {'ForeName': 'Zheng Yang', 'Initials': 'ZY', 'LastName': 'Chin', 'Affiliation': ''}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2009.5335381']
1043,19964884,Development and feasibility study of a sensory-enhanced robot-aided motor training in stroke rehabilitation.,"Functional impairment of the upper limb is a major challenge faced by many stroke survivors. The present study aimed at developing a novel sensory-enhanced robot-aided motor training program and testing its feasibility in stroke rehabilitation. A specially designed robot handle was developed as an attachment to the Inmotion2 robotic system. This handle provided sensory stimulation through pins connected to small servo motors inside the handle. Vibration of the pins was activated during motor training once pressure on the handle reached a certain threshold indicating an active motion of the study subject. Nine chronic stroke survivors were randomly assigned to either a sensory-enhanced robot-aided motor training group (SERMT) or robot-aided motor training only group (RMT). All participants underwent a 6-week motor training program, performing target reaching movements with the specialized handle with or without vibration stimulation during training. Motor Status (MS) scores were measured for functional outcome prior to and after training. The results showed significant improvement in the total MS scores after training in both experimental groups. However, MS sub-scores for the shoulder/elbow and the wrist/hand increased significantly only in the SERMT group (p<0.05). Future studies are required to confirm these preliminary findings.",2009,"However, MS sub-scores for the shoulder/elbow and the wrist/hand increased significantly only in the SERMT group (p<0.05).","['Nine chronic stroke survivors', 'stroke rehabilitation']","['sensory-enhanced robot-aided motor training', 'novel sensory-enhanced robot-aided motor training program', 'sensory-enhanced robot-aided motor training group (SERMT) or robot-aided motor training only group (RMT', 'motor training program, performing target reaching movements with the specialized handle with or without vibration stimulation during training']","['Motor Status (MS) scores', 'MS sub-scores', 'total MS scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0018578', 'cui_str': 'Handling'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",9.0,0.00912532,"However, MS sub-scores for the shoulder/elbow and the wrist/hand increased significantly only in the SERMT group (p<0.05).","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Kansas Medical Center, Kansas City, KS 66160, USA. wliu@kumc.edu'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mukherjee', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tsaur', 'Affiliation': ''}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Natarajan', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Agah', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2009.5334526']
1044,19964981,Detrended Fluctuation Analysis of EEG in detecting cross-modal plasticity in brain for blind.,"Cross-modality is the development of cross link between the modalities in the brain following sensory deprivation in the early stage. Cross modality analysis was previously done with fMRI, MEG and PET images for studying the changes in cerebral activities. Instead of these imaging techniques, this work involves in deriving self similarity parameter using Detrended Fluctuation Analysis of EEG from blind and blind folded normal individuals. This paper presents a novel technique of nonlinear spectral analysis to extract the information from electro encephalograms of humans for the detection of cross- modality existence in blind subjects.",2009,"Instead of these imaging techniques, this work involves in deriving self similarity parameter using Detrended Fluctuation Analysis of EEG from blind and blind folded normal individuals.",[],[],['cerebral activities'],[],[],"[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.185516,"Instead of these imaging techniques, this work involves in deriving self similarity parameter using Detrended Fluctuation Analysis of EEG from blind and blind folded normal individuals.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kalaivani', 'Affiliation': 'Centre for Medical Electronics, Anna University, Chennai, India. kasudha@yahoo.com'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ravindran', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2009.5334638']
1045,19860363,An objective method to determinme corneal changes during menopause.,"OBJECTIVE


We hypothesized that menopause has a measurable effect on corneal thickness. The aim of this study was to evaluate central corneal thickness (CCT) differences between women in the premenopausal and postmenopausal period.
METHODS


A prospective, case-control, single-blind study was designed. Two groups were included: Group I (premenopausal period) and Group II (postmenopausal period). Forty women were recruited in each group. The correlation between CCT with age, estradiol (E2) and follicle stimulating hormone (FSH) levels were evaluated.
RESULTS


CCT was significantly decreased in postmenopausal women compared to premenopausal women (521.18 +/- 37.97 microm 561 +/- 42.84 microm, respectively, p < 0.005). Similarly, there was a linear correlation between CCT and serum E2 levels of patients overall (p < 0.01).
CONCLUSION


The data presented in this study suggest that menopause causes corneal changes, which may be documented by central corneal thickness measurement.",2009,"Similarly, there was a linear correlation between CCT and serum E2 levels of patients overall (p < 0.01).
","['Forty women were recruited in each group', 'postmenopausal women compared to premenopausal women (521.18 ', 'women in the premenopausal and postmenopausal period']",[],"['CCT and serum E2 levels', 'central corneal thickness (CCT) differences', 'CCT with age, estradiol (E2) and follicle stimulating hormone (FSH) levels', 'corneal thickness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0206159', 'cui_str': 'Post-menopausal Period'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement (procedure)'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}]",40.0,0.0811931,"Similarly, there was a linear correlation between CCT and serum E2 levels of patients overall (p < 0.01).
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Keskin', 'Affiliation': 'Department of Obstetrics and Gynecology, Istanbul University Faculty of Medicine, Turkey. nadikeskin@superonline.com'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cantürk', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Aydin', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saygili', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ozgün', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1046,31708327,Dexamethasone for postadenoidectomy pain reduction. Does it truly work? A prospective randomized double-blind clinical trial.,,2020,,[],['Dexamethasone'],[],[],"[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]",[],,0.603594,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Frelich', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital Ostrava, 17, listopadu 1790, 708 52 Ostrava-Poruba, Czech Republic. Electronic address: fno@fno.cz.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Divák', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital Ostrava, 17, listopadu 1790, 708 52 Ostrava-Poruba, Czech Republic.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Vodička', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital Ostrava, 17, listopadu 1790, 708 52 Ostrava-Poruba, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bebej', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital Ostrava, 17, listopadu 1790, 708 52 Ostrava-Poruba, Czech Republic.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sklienka', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Hospital Ostrava, 17, listopadu 1790, 708 52 Ostrava-Poruba, Czech Republic.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Nedopílková', 'Affiliation': 'Hospital Pharmacy, University Hospital Ostrava, 17. listopadu 1790, 708 52 Ostrava-Poruba, Czech Republic.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.109634']
1047,31419483,Gentamicin 240 mg plus azithromycin 2 g vs. ceftriaxone 500 mg plus azithromycin 2 g for treatment of rectal and pharyngeal gonorrhoea: a randomized controlled trial.,"OBJECTIVES


The aim was to evaluate the efficacy and tolerability of gentamicin 240 mg plus azithromycin 2 g for treatment of uncomplicated rectal and pharyngeal gonorrhoea compared to ceftriaxone 500 mg plus azithromycin 2 g, the recommended European first-line gonorrhoea treatment.
METHODS


A non-inferiority, open-label, single-centre randomized controlled trial was conducted in Prague, Czech Republic. Patients, 18-75 years of age, diagnosed with uncomplicated rectal or pharyngeal gonorrhoea by nucleic acid amplification test (NAAT) were randomized to treatment with gentamicin 240 mg intramuscularly plus azithromycin 2 g orally or ceftriaxone 500 g intramuscularly plus azithromycin 2 g orally. The primary outcome was negative culture and negative NAAT, i.e. 1 week and 3 weeks, respectively, after treatment.
RESULTS


Both clinical cure and microbiological clearance was achieved by 100% (95% CI 0.95-1.00) of patients in the gentamicin/azithromycin arm (n = 72; 40 rectal, 17 pharyngeal and 15 rectal+pharyngeal infections both localizations) and 100% (95% CI 0.95-1.00) in ceftriaxone/azithromycin arm (n = 71; 38 rectal, 14 pharyngeal and 19 rectal+pharyngeal infections). The absolute difference between the two arms was 0.0% (CI95% -5.1 to 5.1), thus less than the pre-specified margin of 7%. Administration of gentamicin was not more painful than ceftriaxone according to the visual analogue scale (1.8 vs. 3.4; p <0.001). Gastrointestinal adverse events were similar in the ceftriaxone arm (33/71, 46.5%) and the gentamicin arm (29/72, 40.3%), and overall in most (52/62, 83.9%) cases they were mild.
CONCLUSIONS


Gentamicin 240 mg plus azithromycin 2 g is an effective alternative for treatment of extragenital gonorrhoea.",2020,"Both clinical cure and microbiological clearance was achieved by 100% (95%CI 0.95-1.00) of patients in the gentamicin/azithromycin arm (n=72; 40 rectal, 17 pharyngeal, and 15 rectal+pharyngeal infections both localizations) and 100% (95%CI 0.95-1.00) in ceftriaxone/azithromycin arm (n=71; 38 rectal, 14 pharyngeal, and 19 rectal+pharyngeal infections).","['rectal and pharyngeal gonorrhoea', 'A non-inferiority, open-label, single centre randomized controlled trial was conducted in Prague, Czech Republic', 'Patients, 18-75\xa0years of age, diagnosed with uncomplicated rectal or pharyngeal gonorrhoea by nucleic acid amplification test (NAAT']","['ceftriaxone/azithromycin', 'gentamicin 240 mg intramuscularly plus azithromycin 2 g orally or ceftriaxone 500 g intramuscularly plus azithromycin', 'ceftriaxone 500 mg plus azithromycin', 'Gentamicin 240 mg plus azithromycin', 'gentamicin 240 mg plus azithromycin', 'gentamicin', 'gentamicin/azithromycin', 'ceftriaxone']","['negative culture and negative NAAT', 'clinical cure and microbiological clearance', 'visual analog scale', 'efficacy and tolerability', 'Gastrointestinal adverse events']","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0018081', 'cui_str': 'Neisseria gonorrhoeae Infection'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0200932', 'cui_str': 'Nucleic Acid Amplification Tests'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4050978', 'cui_str': 'Ceftriaxone 500 MG'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.117736,"Both clinical cure and microbiological clearance was achieved by 100% (95%CI 0.95-1.00) of patients in the gentamicin/azithromycin arm (n=72; 40 rectal, 17 pharyngeal, and 15 rectal+pharyngeal infections both localizations) and 100% (95%CI 0.95-1.00) in ceftriaxone/azithromycin arm (n=71; 38 rectal, 14 pharyngeal, and 19 rectal+pharyngeal infections).","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rob', 'Affiliation': 'Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic. Electronic address: filip.rob@gmail.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Klubalová', 'Affiliation': 'Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nyčová', 'Affiliation': 'Department of Microbiology, Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hercogová', 'Affiliation': 'Dermatovenereology Department, Second Medical Faculty, Charles University, Na Bulovce Hospital, Prague, Czech Republic.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Unemo', 'Affiliation': 'World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine of Health, Örebro University, Örebro, Sweden.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2019.08.004']
1048,32050864,Randomized trial to assess safety/feasibility of memantine administration during residential treatment for alcohol use disorder: a pilot study.,"The  N -methyl- D -aspartate receptor (NMDAr) system is critically involved in the pathogenesis and neurobehavioral sequelae of alcohol use disorder (AUD), and constitutes a potential pharmacotherapeutic target. Memantine (Namenda) is an FDA-approved NMDAr antagonist with suggested utility in AUD, however its safety and tolerability during long-term administration among recently-detoxified patients remains uncharacterized. This pilot study assessed safety, feasibility, and several secondary measures of interest, during a 4-week period of residential AUD treatment. Participants ( N  = 18) met diagnostic criteria for AUD. A double-blind, placebo-controlled, escalating-dose design was utilized. Assessments of medication side-effects were conducted weekly. At intake, week 2, and study completion, participants completed a battery assessing affective symptomatology, craving, and neurocognitive function. Medication groups reported equivalent side effects and severity. Medication compliance was high, and did not differ by group. No memantine effects were observed in secondary outcome measures. Memantine maintains a profile of high tolerability and low side-effects during post-detoxification AUD treatment. These data suggest a more aggressive dosing/escalation schedule may be used safely in future trials designed to ascertain improvements in neurocognitive function, affect, and/or craving as primary measures.",2020,Medication groups reported equivalent side effects and severity.,"['alcohol use disorder', 'Participants ( N \u2009=\u200918) met diagnostic criteria for AUD']","['placebo', 'memantine', 'Memantine', 'Memantine (Namenda']","['safety and tolerability', 'equivalent side effects and severity', 'Medication compliance', 'battery assessing affective symptomatology, craving, and neurocognitive function']","[{'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C1330412', 'cui_str': 'Namenda'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3489773', 'cui_str': 'Medication Non-Compliance'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0868684,Medication groups reported equivalent side effects and severity.,"[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Merlo', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Greene', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL, USA.'}]",Journal of addictive diseases,['10.1080/10550887.2020.1721404']
1049,31523022,The effects of music therapy in patients undergoing septorhinoplasty surgery under general anesthesia.,"INTRODUCTION


Music has been used for several years as a relaxation method to reduce stress and anxiety. It is a painless, safe, inexpensive and practical nonpharmacologic therapeutic modality, widely used all over the world.
OBJECTIVES


We aimed to evaluate the effect of music therapy on intraoperative awareness, patient satisfaction, awakening pain and waking quality in patients undergoing elective septorhinoplasty under general anesthesia.
METHODS


This randomized, controlled, prospective study was conducted with 120 patients undergoing septorhinoplasty within a 2 months period. The patients were randomly selected and divided into two groups: group music (music during surgery) and control group (without music during surgery). All patients underwent standard general anesthesia. Patients aged 18-70 years who would undergo a planned surgery under general anesthesia were included. Patients who had emergency surgery, hearing or cognitive impairment, were excluded from the study.
RESULTS


A total of 120 patients were enrolled, and separated into two groups. There were no statistically significant differences between the groups in terms of demographic characteristics, anesthesia and surgery durations (p>0.05). In the music group, sedation agitation scores were lower than those in the control group at the postoperative period (3.76±1.64 vs. 5.11±2.13; p<0.001). In addition; in patients of the music group, the pain level (2.73±1.28 vs. 3.61±1.40) was lower (p<0.001), requiring less analgesic drugs intake.
CONCLUSION


Music therapy, which is a nonpharmacologic intervention, is an effective method, without side effects, leading to positive effects in the awakening, hemodynamic parameters and analgesic requirements in the postoperative period. It is also effective in reducing the anxiety and intraoperative awareness episodes of surgical patients.",2020,"There were no statistically significant differences between the groups in terms of demographic characteristics, anesthesia and surgery durations (p>0.05).","['120 patients were enrolled, and separated into two groups', 'patients undergoing elective septorhinoplasty under general anesthesia', 'Patients aged 18-70 years who would undergo a planned surgery under general anesthesia were included', 'Patients who had emergency surgery, hearing or cognitive impairment, were excluded from the study', '120 patients undergoing septorhinoplasty within a 2 months period', 'patients undergoing septorhinoplasty surgery under general anesthesia']","['group music (music during surgery) and control group (without music during surgery', 'Music therapy', 'music therapy', 'standard general anesthesia']","['demographic characteristics, anesthesia and surgery durations', 'pain level', 'intraoperative awareness, patient satisfaction, awakening pain and waking quality', 'sedation agitation scores']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0189054', 'cui_str': 'Rhinoseptoplasty (procedure)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0919727', 'cui_str': 'Anesthesia Awareness'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",120.0,0.0568432,"There were no statistically significant differences between the groups in terms of demographic characteristics, anesthesia and surgery durations (p>0.05).","[{'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Gökçek', 'Affiliation': 'Diyarbakır Selahaddin Eyyübi State Hospital, Department of Anesthesiology and Reanimation, Diyarbakır, Turkey. Electronic address: gokcekerhan_44@hotmail.com.'}, {'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Kaydu', 'Affiliation': 'Diyarbakır Selahaddin Eyyübi State Hospital, Department of Anesthesiology and Reanimation, Diyarbakır, Turkey.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2019.01.008']
1050,31524780,Acute Neuromuscular and Microvascular Responses to Concentric and Eccentric Exercises With Blood Flow Restriction.,"Lauver, JD, Cayot, TE, Rotarius, TR, and Scheuermann, BW. Acute neuromuscular and microvascular responses to concentric and eccentric exercises with blood flow restriction. J Strength Cond Res 34(10): 2725-2733, 2020-The purpose of this study was to investigate the effects of the addition of blood flow restriction (BFR) during concentric and eccentric exercises on muscle excitation and microvascular oxygenation status. Subjects (N = 17) were randomly assigned to either a concentric (CON, CON + BFR) or eccentric (ECC, ECC + BFR) group, with one leg assigned to BFR and the other to non-BFR. Surface electromyography and near-infrared spectroscopy were used to measure muscle excitation and microvascular deoxygenation (deoxy-[Hb + Mb]) and [total hemoglobin concentration] during each condition, respectively. On separate days, subjects completed 4 sets (30, 15, 15, 15) of knee extension exercise at 30% maximal torque, and 1 minute of rest was provided between the sets. Greater excitation of the vastus medialis was observed during CON + BFR (54.4 ± 13.3% maximal voluntary isometric contraction [MVIC]) and ECC + BFR (53.0 ± 18.0% MVIC) compared with CON (42.0 ± 10.8% MVIC) and ECC (46.8 ± 9.6% MVIC). Change in deoxy-[Hb + Mb] was greater during CON + BFR (10.0 ± 10.4 μM) than during CON (4.1 ± 4.0 μM; p < 0.001). ECC + BFR (7.8 ± 6.7 μM) was significantly greater than ECC (3.5 ± 4.7 μM; p = 0.001). Total hemoglobin concentration was greater for ECC + BFR (7.9 ± 4.4 μM) compared with ECC (5.5 ± 3.5 μM). The addition of BFR to eccentric and concentric exercises resulted in a significant increase in metabolic stress and muscle excitation compared with non-BFR exercise. These findings suggest that although BFR may increase the hypertrophic stimulus during both modes of contraction, BFR during concentric contractions may result in a greater stimulus.",2020,Total hemoglobin concentration was greater for ECC + BFR (7.9 ± 4.4 μM) compared with ECC (5.5 ± 3.5 μM).,['Subjects (N = 17'],"['knee extension exercise', 'Concentric and Eccentric Exercises', 'concentric (CON, CON + BFR) or eccentric (ECC, ECC + BFR', 'concentric and eccentric exercises with blood flow restriction', 'blood flow restriction (BFR) during concentric and eccentric exercises', 'J Strength Cond Res XX(X']","['ECC + BFR', 'Lauver, JD, Cayot, TE, Rotarius, TR, and Scheuermann, BW', 'Greater excitation of the vastus medialis', 'hypertrophic stimulus', 'muscle excitation and microvascular deoxygenation (deoxy-[Hb + Mb]) and [total hemoglobin concentration', 'Total hemoglobin concentration', 'muscle excitation and microvascular oxygenation status', 'metabolic stress and muscle excitation']",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]","[{'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0224445', 'cui_str': 'Vastus Medialis'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2350024', 'cui_str': 'Metabolic Stress'}]",,0.0186598,Total hemoglobin concentration was greater for ECC + BFR (7.9 ± 4.4 μM) compared with ECC (5.5 ± 3.5 μM).,"[{'ForeName': 'Jakob D', 'Initials': 'JD', 'LastName': 'Lauver', 'Affiliation': 'Department of Kinesiology, Coastal Carolina University, Conway, South Carolina.'}, {'ForeName': 'Trent E', 'Initials': 'TE', 'LastName': 'Cayot', 'Affiliation': 'Department of Kinesiology, Health, and Sport Sciences, University of Indianapolis, Indianapolis, Indiana.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Rotarius', 'Affiliation': 'Department of Exercise Science and Athletic Training, Adrian College, Adrian, Michigan.'}, {'ForeName': 'Barry W', 'Initials': 'BW', 'LastName': 'Scheuermann', 'Affiliation': 'School of Exercise and Rehabilitation Sciences, The University of Toledo, Toledo, Ohio.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003372']
1051,18390083,"Continuous oral or intramuscular medroxyprogesterone acetate versus the levonorgestrel releasing intrauterine system in the treatment of perimenopausal menorrhagia: a randomized, prospective, controlled clinical trial in female smokers.","OBJECTIVE


To compare the efficacy of three progestin regimens in perimenopausal menorrhagia.
DESIGN


One hundred thirty-two women with menorrhagia were included in this prospective, randomized, comparative trial. Women were randomized to three groups of 44 in each, either to get a single shot of depot medroxyprogesterone acetate, intramuscularly (Group 1), or medroxyprogesterone acetate in a daily dose of 5 mg orally (Group 2), or the levonorgestrel releasing intrauterine system (LNG-IUS) (Group 3). The Mann-Whitney U-test was applied to compare independent groups.
RESULTS


Pictorial blood loss assessment chart (PBAC) score, the duration of bleeding and mean hemoglobin level were improved in all groups. Comparing the groups we noted that for the PBAC, there was no statistically significant difference between groups 1 and 2, while group 3 was superior to both groups 1 and 2 (p < 0.05 and p < 0.05, respectively). Mean duration of menstruation showed no differences among the groups. Hemoglobin levels were no statistically significant differences between groups 1 and 2, while group 3 was superior to both groups 1 and 2 (p < 0.05 and p < 0.05, respectively).
CONCLUSION


The efficacies of oral and intramuscular medroxyprogesterone acetate in the treatment of menorrhagia were comparable each other, however, the efficacy of LNG-IUS was superior to both.",2008,"The efficacies of oral and intramuscular medroxyprogesterone acetate in the treatment of menorrhagia were comparable each other, however, the efficacy of LNG-IUS was superior to both.","['One hundred thirty-two women with menorrhagia', 'perimenopausal menorrhagia', 'female smokers']","['levonorgestrel releasing intrauterine system', 'medroxyprogesterone acetate', 'depot medroxyprogesterone acetate', 'levonorgestrel releasing intrauterine system (LNG-IUS', 'progestin regimens']","['Hemoglobin levels', 'Mean duration of menstruation', 'Pictorial blood loss assessment chart (PBAC', 'duration of bleeding and mean hemoglobin level']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1708694', 'cui_str': 'Levonorgestrel-releasing intrauterine system'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0684240', 'cui_str': 'Chart'}]",132.0,0.0351969,"The efficacies of oral and intramuscular medroxyprogesterone acetate in the treatment of menorrhagia were comparable each other, however, the efficacy of LNG-IUS was superior to both.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Küçük', 'Affiliation': 'Department of Obstetrics and Gynecology, GATA School of Medicine, Ankara, Turkey. tansukucuk@gmail.com'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ertan', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1052,18390085,A prospective randomized trial of labor induction with vaginal controlled-release dinoprostone inserts with or without oxytocin and misoprostol+oxytocin.,"OBJECTIVE


This study was designed in an aim to compare the efficacies of three labor induction methods, dinoprostone (PGE2) vaginal insert with or without concomittant oxytocin and misoprostol (PGE1) combined with oxytocin infusion.
METHODS


This was a prospective observational trial of nulliparous women undergoing labor induction from December 2006 to January 2007. Inclusion criteria were: gestational age between 36 to 42 weeks, singleton cephalic presentation of the fetus, intact membrane and unfavorable cervical Bishop score < 6, and absence of spontaneous uterine contractions. Participants were then randomly assigned to preinduction cervical ripening with a dinoprostone vaginal insert (10 mg) administered into the posterior fornix for a total of 12 hours without oxytocin (group I); with oxytocin (group II), and with misoprostol (50 microg) intravaginally in the posterior fornix with repeat dosing at 6-hour intervals with a maximum dose of four with oxytocin (group III).
RESULTS


A total number of 106 women met the inclusion criteria without distribution for 19 cases in group I, 44 and 43 cases in groups II and III, respectively. There were no statistically significant differences in terms of the demographic characteristics, indication of labor induction, interval from-induction-to-delivery, cardiotocographic abnormalities and neonatal outcomes and mode of deliveries among the three groups (p > 0.05).
CONCLUSIONS


Three methods of labor induction were equally efficient in achieving succesful delivery without any maternal and fetal adverse outcomes.",2008,"There were no statistically significant differences in terms of the demographic characteristics, indication of labor induction, interval from-induction-to-delivery, cardiotocographic abnormalities and neonatal outcomes and mode of deliveries among the three groups (p > 0.05).
","['Inclusion criteria were: gestational age between 36 to 42 weeks, singleton cephalic presentation of the fetus, intact membrane and unfavorable cervical Bishop score < 6, and absence of spontaneous uterine contractions', '106 women met the inclusion criteria without distribution for 19 cases in group I, 44 and 43 cases in groups II and III, respectively', 'nulliparous women undergoing labor induction from December 2006 to January 2007']","['oxytocin', 'vaginal controlled-release dinoprostone', 'dinoprostone (PGE2) vaginal insert with or without concomittant oxytocin and misoprostol (PGE1) combined with oxytocin infusion', 'misoprostol', 'oxytocin and misoprostol+oxytocin', 'preinduction cervical ripening with a dinoprostone vaginal insert (10 mg) administered into the posterior fornix for a total of 12 hours without oxytocin']","['demographic characteristics, indication of labor induction, interval from-induction-to-delivery, cardiotocographic abnormalities and neonatal outcomes and mode of deliveries']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2979973'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes (finding)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0042130', 'cui_str': 'Myometrial Contraction'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C1719963', 'cui_str': 'Conventional release vaginal insert'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0227796', 'cui_str': 'Structure of posterior fornix'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]",12.0,0.0470109,"There were no statistically significant differences in terms of the demographic characteristics, indication of labor induction, interval from-induction-to-delivery, cardiotocographic abnormalities and neonatal outcomes and mode of deliveries among the three groups (p > 0.05).
","[{'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Tanir', 'Affiliation': 'Department of Obstetrics and Gynecology, Perinatology Unit, Eskisehir Osmangazi University School of Medicine, Eskisehir, Turkey. mtanir@superonline.com'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sener', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Yildiz', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kaya', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kurt', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1053,31244398,The Effects of News Coverage of Epidemics on Public Support for and Compliance with the CDC- An Experimental Study.,"Content analysis identified three dominant themes used by the news media to cover epidemics: the scientific, the pandemic, and the social. This study uses a randomized experimental design to test the effects of common news coverage patterns of epidemics on perceptions of efficacy, certainty, and trust in the CDC, and subsequently on intentions to comply with and support for the CDC during public health crises. The experiment also compares the effects of real-world coverage to that of hypothetical coverage that more closely follows the CDC's recommendations for crisis communication. The results of the experiment (n = 321) demonstrate that exposure to articles from different themes affects perceptions of certainty and self-efficacy, that in turn affect intentions to comply with the CDC. Although organizational-efficacy and trust in the CDC are both correlated with intentions to support, and trust is also correlated with intentions to comply, exposure to different conditions did not affect these perceptions and there was no indirect effect from exposure to intentions. The results reveal the potential effects of real-world coverage on perceptions and intentions, and demonstrate the advantage of the hypothetical coverage that follows the CDC's crisis communication guidelines. Implications for public health organizations and communicators are discussed.",2019,"The results of the experiment (n = 321) demonstrate that exposure to articles from different themes affects perceptions of certainty and self-efficacy, that in turn affect intentions to comply with the CDC.",[],[],[],[],[],[],321.0,0.012992,"The results of the experiment (n = 321) demonstrate that exposure to articles from different themes affects perceptions of certainty and self-efficacy, that in turn affect intentions to comply with the CDC.","[{'ForeName': 'Yotam', 'Initials': 'Y', 'LastName': 'Ophir', 'Affiliation': 'a The Department of Communication, University at Buffalo, State University of New York , Buffalo , NY , USA.'}]",Journal of health communication,['10.1080/10810730.2019.1632990']
1054,17937086,Safety and effectiveness of tinzaparin sodium in the management of recurrent pregnancy loss.,"PURPOSE


To assess the safety and efficacy of tinzaparin sodium for the management of recurrent pregnancy loss.
METHODS


The study included 62 women with a history of recurrent pregnancy loss and at least one factor of thrombophilic disorder. Of these, 31 received 50 IU/kg of tinzaparin sodium daily (Group A), and 33 received 100 mg of aspirin daily (Group B).
RESULTS


Group A subjects (receiving tinzaparin sodium) had six new abortions, whereas Group B subjects (receiving aspirin) had 11 (significant difference). Cases of intrauterine growth restriction (none in Group A and 2 in Group B), placental abruption (one in Group A and 4 in Group B), and preeclampsia (one in Group A and 3 in Group B) were comparable between the two groups. Finally coagulation disorders (none in Group A and 6 in Group B) were significantly fewer in Group A.
CONCLUSION


A 50 IU/kg daily dose of tinzaparin sodium seems to be effective for the management of recurrent abortion and has high standards of safety.",2007,A 50 IU/kg daily dose of tinzaparin sodium seems to be effective for the management of recurrent abortion and has high standards of safety.,['62 women with a history of recurrent pregnancy loss and at least one factor of thrombophilic disorder'],"['aspirin', 'tinzaparin sodium']","['placental abruption', 'safety and efficacy', 'recurrent pregnancy loss', 'Finally coagulation disorders']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C2921106', 'cui_str': 'Recurrent pregnancy loss'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0354599', 'cui_str': 'Tinzaparin sodium'}]","[{'cui': 'C0000832', 'cui_str': 'Placental Abruption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2921106', 'cui_str': 'Recurrent pregnancy loss'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}]",62.0,0.0191151,A 50 IU/kg daily dose of tinzaparin sodium seems to be effective for the management of recurrent abortion and has high standards of safety.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dendrinos', 'Affiliation': '2nd Department of Obstetrics and Gynecology, University of Athens, Aretaieion Hospital, Athens, Greece.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kalogirou', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Makrakis', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Theodoridis', 'Affiliation': ''}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Mahmound', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Christopoulou-Cokkinou', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Creatsas', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1055,18003434,Connectivity analysis of EEG under drug therapy.,"Analysis of human EEG constitutes a useful instrument for the evaluation of drug bioavailability at the brain. Linear and nonlinear techniques were applied to EEG signals for the assessment of brain connectivity after drug intake by coherence and cross mutual information, respectively. The main goal was to evaluate the pharmacological effect of different doses of alprazolam on the brain during wakefulness. Preliminary results reported in this work showed statistically significant differences in EEG channels coupling between the states corresponding to placebo and different drug doses. However, nonlinear variables correlated better with the expected within-doses and within-time effects.",2007,"Linear and nonlinear techniques were applied to EEG signals for the assessment of brain connectivity after drug intake by coherence and cross mutual information, respectively.",[],"['alprazolam', 'placebo']",['EEG channels coupling'],[],"[{'cui': 'C0002333', 'cui_str': 'Alprazolam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]",,0.0346152,"Linear and nonlinear techniques were applied to EEG signals for the assessment of brain connectivity after drug intake by coherence and cross mutual information, respectively.","[{'ForeName': 'Joan F', 'Initials': 'JF', 'LastName': 'Alonso', 'Affiliation': 'Biomedical Engineering Research Centre, Automatic Control Department, Technical University of Catalonia (UPC), Barcelona, Spain. joan.francesc.alonso@upc.edu'}, {'ForeName': 'Miquel A', 'Initials': 'MA', 'LastName': 'Mañanas', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Romero', 'Affiliation': ''}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Riba', 'Affiliation': ''}, {'ForeName': 'Manel J', 'Initials': 'MJ', 'LastName': 'Barbanoj', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hoyer', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,[]
1056,18001879,Study of the EEG changes during the combined ingestion of alcohol and H1-antihistamines by using the wavelet transform.,"H(1)-antihistamines affect the central nervous system (CNS) and, therefore, electroencephalographic (EEG) changes should be expected to occur. The principal aim of this work was to assess the effects on the EEG when hydroxyzine 10 mg (HY) and cetirizine 25 mg (CE) were administered with and without alcohol 0.8 g/kg (AL). Thirty-three healthy young subjects participated in two placebo-controlled trials. In the first one, 15 subjects received placebo (PL), HY and CE. In the second trial, 18 volunteers took PL, AL, and AL in combination with HY and CE. CNS effects of the different treatment conditions were evaluated at baseline, as well as at +4 h and +1 h post-medication for each study, respectively. EEG recordings from electrodes O1 and O2 were analyzed using the wavelet transform. Then, several entropies were calculated from wavelet decomposition to detect changes in the pattern of regularity of the signals. The obtained results suggest that the concomitant ingestion of AL with HY reduces the changes in the irregularity of the EEG, opposite to the behavior observed for CE. Hence, wavelet entropies could be useful descriptors of the EEG alterations induced by several drugs in a different way that the conventional Fourier-based methods.",2007,"CNS effects of the different treatment conditions were evaluated at baseline, as well as at +4 h and +1 h post-medication for each study, respectively.",['Thirty-three healthy young subjects participated in two'],"['placebo (PL), HY and CE', 'placebo', 'hydroxyzine', 'cetirizine 25 mg (CE']",[],"[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020404', 'cui_str': 'Hydroxyzine'}, {'cui': 'C0055147', 'cui_str': 'Cetirizine'}]",[],33.0,0.0266736,"CNS effects of the different treatment conditions were evaluated at baseline, as well as at +4 h and +1 h post-medication for each study, respectively.","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Poza', 'Affiliation': 'Biomedical Engineering Group (GIB), Department TSCIT, University of Valladolid, Camino del Cementerio s/n, 47011-Valladolid, Spain. jesus.poza@tel.uva.es'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Caminal', 'Affiliation': ''}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Vallverdú', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hornero', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Romero', 'Affiliation': ''}, {'ForeName': 'Manuel J', 'Initials': 'MJ', 'LastName': 'Barbanoj', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,[]
1057,18002801,"Using a telemedicine system to decrease cardiovascular disease risk in an underserved population: design, use, and interim results.","Cardiovascular disease is the leading cause of morbidity and mortality in the USA. Disease management programs, while successful, are intensive and expensive. Follow-up is often inadequate, incomplete, and inconsistent. To address these problems, we developed an Internet-Telemedicine system. Patients send/receive data to/from their care provider via the Internet. The system optimizes function and minimizes cost (all hardware is off the shelf and FDA approved). We are currently using this Telemedicine system in a prospective, randomized clinical trial, to reduce CVD risk in medically underserved populations. Over an 8-month time interval, we found very high rates of usage of the Telemedicine system (92%). This rate of self-monitoring greatly exceeded the self-monitoring rate in controls (48%). The patient-entered Telemedicine blood pressure values were similar to the meter recorded values and to the office values.",2007,The patient-entered Telemedicine blood pressure values were similar to the meter recorded values and to the office values.,"['medically underserved populations', 'underserved population']",['telemedicine system'],"['Telemedicine blood pressure values', 'cardiovascular disease risk']","[{'cui': 'C4551781', 'cui_str': 'Medically Underserved Population'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0364167,The patient-entered Telemedicine blood pressure values were similar to the meter recorded values and to the office values.,"[{'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Santamore', 'Affiliation': 'Physiology Department, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Homko', 'Affiliation': ''}, {'ForeName': 'Abul', 'Initials': 'A', 'LastName': 'Kashem', 'Affiliation': ''}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'McConnell', 'Affiliation': ''}, {'ForeName': 'Alfred A', 'Initials': 'AA', 'LastName': 'Bove', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,[]
1058,18002817,A neuro-fuzzy controller for the estimation of tidal volume and respiration frequency ventilator settings for COPD patients ventilated in control mode.,"Patients with chronic obstructive pulmonary disease (COPD) are characterized by increased work of breathing (WOB) and ventilatory muscle dysfunction. Mechanical ventilation is applied to unload the WOB; rest respiratory muscles decrease arterial partial pressure of carbon dioxide (PaCO2) and treat hypoxemia. Since patients' needs are not static, ventilator settings have to be adjusted regularly. The aim of the present study was the development and evaluation of a neuro-fuzzy controller, that utilizes non-invasively acquired parameters for the determination of the appropriate tidal volume (VT) and respiration frequency (RR) ventilator settings for COPD patients. Forty three (43) hours of non-invasively monitored physiology parameters and ventilator settings, from four (4) different COPD patients ventilated in control mode, were collected in two (2) General Hospitals in Greece. Recorded data were randomly allocated into two sets, namely training set (60%) and evaluation set (40%). A neuro-fuzzy controller was developed and trained, by employing the training set. The controller utilizes non-invasively measured parameters, namely oxygen saturation (SpO2), lung compliance (C) and resistance (R), Peak Inspiratory pressure (PIP) and Plateau pressure (Pplateau), for predicting appropriate VT and RR settings. The developed neuro-fuzzy controller was tested against evaluation set. The Mean Square Error of the tidal volume and the respiration rate was 0.222 ml/Kgr and 1.21 breaths per minute (bpm) respectively.",2007,The Mean Square Error of the tidal volume and the respiration rate was 0.222 ml/Kgr and 1.21 breaths per minute (bpm) respectively.,"['COPD patients', 'COPD patients ventilated in control mode', 'Forty three (43) hours of non-invasively monitored physiology parameters and ventilator settings, from four (4) different COPD patients ventilated in control mode, were collected in two (2) General Hospitals in Greece', 'Patients with chronic obstructive pulmonary disease (COPD']",['Mechanical ventilation'],"['appropriate tidal volume (VT) and respiration frequency (RR) ventilator settings', 'Mean Square Error of the tidal volume and the respiration rate', 'controller utilizes non-invasively measured parameters, namely oxygen saturation (SpO2), lung compliance (C) and resistance (R), Peak Inspiratory pressure (PIP) and Plateau pressure (Pplateau), for predicting appropriate VT and RR settings', 'arterial partial pressure of carbon dioxide (PaCO2) and treat hypoxemia']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0018226', 'cui_str': 'Greece'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0024112', 'cui_str': 'Lung Compliance'}, {'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0445176', 'cui_str': 'Plateau pressure (qualifier value)'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}]",,0.0312236,The Mean Square Error of the tidal volume and the respiration rate was 0.222 ml/Kgr and 1.21 breaths per minute (bpm) respectively.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tzavaras', 'Affiliation': 'Medical Instrumentation Technology Department, Technological Education Institute of Athens, GR 12210 Athens, Greece. tzavaris@otenet.gr'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Weller', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Spyropoulos', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,[]
1059,18003042,The effect of music on hypertensive patients.,"The aim of this study is to examine if, and to what extent, daily listening to a certain type of music can help hypertensive patients lower their blood pressure (BP). Experiments were conducted at an elderly home. Thirty subjects aged 63-93 years participated in the study and were randomly assigned into either a music group (n=15) or a control group (n=15). There were no significant differences between the two groups in initial BP values, age, gender, or medication status. Subjects in the music group listened to selected music, 25 min every day for 4 weeks. BP was measured twice a week by a registered nurse with a sphygmomanometer during the 4-week study period and after the completion of the study. Four subjects dropped from the experiment due to a change of medical conditions or to personal reasons. After 4 weeks, the average decrease for the music group (n=12) in systolic BP (SBP) and diastolic BP (DBP) was 11.8 mmHg (p=0.008) and 4.7 mmHg (p=0.218), respectively, whereas there was no significant changes in SBP or DBP for the control group (n=14). The results suggest that listening to a certain type of music serves to reduce high SBP and therefore music therapy may be an alterative for hypertension treatment.",2007,"There were no significant differences between the two groups in initial BP values, age, gender, or medication status.","['Thirty subjects aged 63-93 years participated in the study', 'hypertensive patients']","['music group', 'control group']","['SBP or DBP', 'BP', 'initial BP values, age, gender, or medication status', 'systolic BP (SBP) and diastolic BP (DBP', 'blood pressure (BP']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",30.0,0.0207497,"There were no significant differences between the two groups in initial BP values, age, gender, or medication status.","[{'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Teng', 'Affiliation': 'Joint Research Center for Biomedical Engineering, Department of Electronic Engineering, The Chinese University of Hong Kong, Shatin, N. T., Hong Kong.'}, {'ForeName': 'M Y M', 'Initials': 'MY', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Zhang', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,[]
1060,18003511,A new method for evaluating the performance of depth-of-hypnosis indices - the D-value.,"An alternative statistic, the D-value, is presented for the evaluation of the performance of EEG-based depth-of-hypnosis measures against the Observers' Assessment of Alertness/Sedation scale. The measures considered here are spectral entropy, approximate entropy, Lempel-Ziv complexity and Higuchi fractal dimension. The study is based on recordings from 45 patients, divided into three groups of 15 recordings each. Patients of Group I received no remifentanil while patients of Groups II and III received 2 and 4 ng/ml effect compartment controlled remifentanil. All the patients received stepwise increased dose of propofol. The study shows that the D-value is a promising and flexible statistic for the evaluation of the discriminative power of the EEG measures with respect to the OAA/S scale. The D-value indicates well the dependence of the performance of the measures on the EEG frequency band as well as on remifentanil concentration.",2007,The study shows that the D-value is a promising and flexible statistic for the evaluation of the discriminative power of the EEG measures with respect to the OAA/S scale.,"['45 patients, divided into three groups of 15 recordings each']","['propofol', 'remifentanil']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]",[],45.0,0.0154951,The study shows that the D-value is a promising and flexible statistic for the evaluation of the discriminative power of the EEG measures with respect to the OAA/S scale.,"[{'ForeName': 'Tarmo', 'Initials': 'T', 'LastName': 'Lipping', 'Affiliation': 'Pori unit of Tampere University of Technology, Pori, Finland. tarmo.lipping@tut.fi'}, {'ForeName': 'Rain', 'Initials': 'R', 'LastName': 'Ferenets', 'Affiliation': ''}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Mortier', 'Affiliation': ''}, {'ForeName': 'Michel M F', 'Initials': 'MM', 'LastName': 'Struys', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,[]
1061,17089581,Placental umbilical cord blood transfusion: a new method of treatment of patients with diabetes and microalbuminuria in the background of anemia.,"Diabetes mellitus is the commonest endocrine disease in all populations and all age groups. It is a syndrome of disturbed intermediary metabolism caused by inadequate insulin secretion or impaired insulin action, or both. Anemia is a common accompaniment of diabetes, particularly in those with albuminuria justifying tubulointestitial injury or reduced renal function. There are other additional factors present in diabetes, which may contribute to the development of an increased risk of anemia. Cord blood, because of its rich mix of fetal and adult hemoglobin, high platelet and WBC counts, hypo-antigenic nature, altered metabolic profile and high affinity for oxygen, may be an ideal choice for cases of diabetes with severe anemia necessitating blood transfusion. This article presents my team's experience with 78 units of placental umbilical cord whole blood (from 1 April 1999 to April 2005), collected after lower uterine cesarean section (LUCS) from consenting mothers (56 ml-138, ml mean 82 ml +/- 5.6 ml SD, median 84 ml, mean packed cell volume 49.7 +/- 4.2 SD, mean percent hemoglobin concentration 16.6 g/dl +/- 1.5 g/dl SD) and transfused to diabetes patients with microalbuminuria and severe anemia necessitating transfusion. After collection, the blood was transfused, in most cases immediately after completion of the essential norms of transfusion. In rare cases, it was kept in the refrigerator and transfused within 72 hours of collection to a suitable recipient. For inclusion in this study, the patient's percent plasma hemoglobin had to be 8 g/dl or less (the pretransfusion hemoglobin in this series varied from 5.2 g/dl to 7.8 g/dl) in the background of type two diabetes (fasting sugar 200 mg or more), along with features of microalbuminuria (albumin excretion 30-299 mg/g creatinine). This study included 39 informed consenting patients (22 males + 17 females, aged 48-74 yrs, mean 59.6 yrs). The patients were randomized into two groups: Group A (control cases N = 15, males = 8 and females = 7) and Group B (study group N = 24, males = 14 and females = 10). In Group A the rise of hemoglobin (Hgb) after two units of adult blood transfusion was 1.5 to 1.8 g/dl, as seen after a 72-hour blood sample assessment. The rise of Hgb as noted after 72 hours of two units of freshly collected cord blood transfusion was .6 g/dl to 1.5 g/dl. Each patient received two of four units of freshly collected cord blood transfusion (two units at a time), depending on availability and compatibility. Microalbuminuria was assessed in both groups after one month of treatment with transfusion and other identical support. The mean result was 152 +/- 18 m SD of albumin per gram of creatinine excreted through 24-hour urine (pre-transfusion mean excretion was 189 +/- 16 mg) in Group A and 103 +/- 16 mg SD of albumin excretion per gram of creatinine in 24-hour excretion of urine in Group B (pretransfusion mean excretion was 193 +/- 21 mg). Univariate analysis using Fisher's exact test was performed for the results of Groups A and B. The difference between Group A and B values and its comparison with the pre-transfusion microalbuminuria appeared to be statistically significant (p < less than .003). We have not encountered any clinical, immunological or non-immunological reaction so far in either group. Fetomaternal cell traffic has been implicated as the cause of scleroderma in mothers delivering male babies. In the present series, we did not see any such rare and unusual complication due to neonatal blood transfusion in the adult system in Group B patients in the six years from the initiation of the study.",2006,The difference between Group A and B values and its comparison with the pre-transfusion microalbuminuria appeared to be statistically significant (p < less than .003).,"['mothers delivering male babies', 'cases of diabetes with severe anemia necessitating blood transfusion', 'diabetes patients with microalbuminuria and severe anemia necessitating transfusion', ""my team's experience with 78 units of placental umbilical cord whole blood (from 1 April 1999 to April 2005), collected after lower uterine cesarean section (LUCS) from consenting mothers (56 ml-138, ml mean 82 ml "", 'cases N = 15, males = 8 and females = 7) and Group B (study group N = 24, males = 14 and females = 10', '39 informed consenting patients (22 males + 17 females, aged 48-74 yrs, mean 59.6 yrs', 'patients with diabetes and microalbuminuria in the background of anemia']",['Placental umbilical cord blood transfusion'],"['Microalbuminuria', 'rise of hemoglobin (Hgb']","[{'cui': 'C0566687', 'cui_str': 'Mother delivered (finding)'}, {'cui': 'C0419384', 'cui_str': 'Baby male (finding)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0041633', 'cui_str': 'Umbilical Cord'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]","[{'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",39.0,0.0755657,The difference between Group A and B values and its comparison with the pre-transfusion microalbuminuria appeared to be statistically significant (p < less than .003).,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bhattacharya', 'Affiliation': 'Bijoygarh State Hospital, Moore Avenue Specialist Polyclinic, Calcutta, India.'}]",Clinical and experimental obstetrics & gynecology,[]
1062,31820674,Performance of randomization-based causal methods with and without integrating external data sources for adjusting overall survival in case of extensive treatment switches in placebo-controlled randomized oncology phase 3 trials.,"In recent placebo-controlled randomized phase 3 oncology trials, evaluation of overall survival with frequent crossover is crucial for regulatory and pricing decisions. The problem is that an intention-to-treat based analysis causes a substantial loss of power to detect causal survival effect without crossover, and performance of existing methods is not satisfactory. In this article, our aims were to evaluate properties of the existing and a proposed Bayesian power prior method where data from an external trial is available. Simulation results suggested that proposed method was the most powerful under typical scenarios where patients with better prognosis are likely to crossover.",2020,Simulation results suggested that proposed method was the most powerful under typical scenarios where patients with better prognosis are likely to crossover.,[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.58588,Simulation results suggested that proposed method was the most powerful under typical scenarios where patients with better prognosis are likely to crossover.,"[{'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Nomura', 'Affiliation': 'Center for Research and Administration and Support, National Cancer Center, Chiba, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Shinozaki', 'Affiliation': 'Department of Information and Computer Technology, Graduate School of Engineering, Tokyo University of Science, Tokyo, Japan.'}, {'ForeName': 'Chikuma', 'Initials': 'C', 'LastName': 'Hamada', 'Affiliation': 'Department of Information and Computer Technology, Graduate School of Engineering, Tokyo University of Science, Tokyo, Japan.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2019.1695625']
1063,17211965,"Double-blind, placebo-controlled study of Fertilityblend: a nutritional supplement for improving fertility in women.","PURPOSE


To determine the impact of nutritional supplementation on female fertility.
METHODS


A double blind, placebo-controlled study of the effects of FertilityBlend for Women, a proprietary nutritional supplement containing chasteberry, green tea, L-arginine, vitamins (including folate) and minerals, on progesterone level, basal body temperature, menstrual cycle length, pregnancy rate and side-effects.
RESULTS


Ninety-three (93) women, aged 24-42 years, who had tried unsuccessfully to conceive for six to 36 months, completed the study. After three months, the FertilityBlend (FB) group (N = 53) demonstrated a trend toward increased mean mid-luteal progesterone (P(ml)), but among women with basal pretreatment P(ml) < 9 ng/ml, the increase in progesterone was highly significant. The average number of days with luteal-phase basal temperatures over 98 degrees F increased significantly in the FB group. Both short and long cycles (< 27 days or > 32 days pretreatment) were normalized in the FB group. The placebo group (N = 40) did not show any significant changes in these parameters. After three months, 14 of the 53 women in the FB group were pregnant (26%) compared to four of the 40 women in the placebo group (10%; p = 0.01). Three additional women conceived after six months on FB (32%). No significant side-effects were noted.
CONCLUSION


Nutritional supplements could provide an alternative or adjunct to conventional fertility therapies.",2006,"No significant side-effects were noted.
","['Ninety-three (93) women, aged 24-42 years, who had tried unsuccessfully to conceive for six to 36 months, completed the study', 'women', 'women with basal pretreatment P(ml']","['Fertilityblend', 'placebo', 'nutritional supplementation']","['green tea, L-arginine, vitamins (including folate) and minerals, on progesterone level, basal body temperature, menstrual cycle length, pregnancy rate and side-effects', 'mean mid-luteal progesterone (P(ml', 'average number of days with luteal-phase basal temperatures', 'progesterone', 'side-effects']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}]","[{'cui': 'C1384640', 'cui_str': 'Green Tea'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0576806', 'cui_str': 'Basal body temperature (observable entity)'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",,0.138748,"No significant side-effects were noted.
","[{'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Westphal', 'Affiliation': 'Department of Gynecology/Obstetrics, Stanford University School of Medicine, Stanford, CA 94305, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Polan', 'Affiliation': ''}, {'ForeName': 'A Sontag', 'Initials': 'AS', 'LastName': 'Trant', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1064,17211970,Postoperative analgesia after cesarean section by continued administration of levobupivacaine with the On-Q Painbuster system over the fascia vs ketorolac + morphine i.v.,"OBJECTIVE


This study aimed to detect if continuous local infusion of levobupivacaine with the On-Q Painbuster system provided postoperative analgesia of similar quality to morphine + ketorolac i.v. in patients undergoing cesarean section.
MATERIALS AND METHODS


Using a randomized prospective double-blind study, 20 women undergoing cesarean section with a standardized spinal technique were randomly assigned into two groups to receive either 10 mg morphine + 120 mg ketorolac + saline solution up to 96 ml with an elastomeric pump i.v. (group A) or local infusion of levobupivacaine 0.2% with the On-Q PAINBUSTER system (group B). Both groups were administered ketorolac i.v. in bolus in case of pain.
RESULTS


The two groups differed in their VAS scores with group A experiencing significantly less pain than group B; the consumption of analgesics was significantly lower in group A than in group B.
CONCLUSIONS


The i.v. system with morphine and ketorolac is more effective than levobupivacaine subcutaneous infusion in reducing postoperative pain associated with cesarean section.",2006,"The two groups differed in their VAS scores with group A experiencing significantly less pain than group B; the consumption of analgesics was significantly lower in group A than in group B.
CONCLUSIONS


The i.v.","['patients undergoing cesarean section', '20 women undergoing cesarean section with a standardized spinal technique']","['morphine + ketorolac i.v', 'ketorolac', 'morphine and ketorolac', 'ketorolac + morphine', 'levobupivacaine subcutaneous infusion', 'levobupivacaine', 'morphine + 120 mg ketorolac + saline solution up to 96 ml with an elastomeric pump i.v']","['pain', 'consumption of analgesics', 'Postoperative analgesia', 'postoperative pain', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0576773', 'cui_str': 'Subcutaneous Infusions'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0444925', 'cui_str': 'elastomeric'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",20.0,0.133124,"The two groups differed in their VAS scores with group A experiencing significantly less pain than group B; the consumption of analgesics was significantly lower in group A than in group B.
CONCLUSIONS


The i.v.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Magnani', 'Affiliation': 'Department of Gynecology, University of Rome ""La Sapienza"", Rome, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Corosu', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mancino', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Borgia', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1065,31904670,Efficacy of a Short Psychoeducational Group Intervention for the Prevention of Cardiovascular Risk in Patients With Severe Mental Disorder: A Randomized Trial.,"Psychoeducational interventions to improve healthy habits regarding cardiovascular risk (CVR) in people with a severe mental disorder showed scarce results in the literature. In this article, we showed the results of a randomized clinical trial including 80 adult outpatients (mainly psychosis spectrum) with moderate to very high CVR. A short-term psychoeducational group intervention to improve healthy habits regarding CVR was added to their as-usual individual psychoeducational schedule. With an intention-to-treat analysis, we expected improvements in the different parameters. Baseline and 1-year follow-up included CVR factors and indexes (REGICOR, SCORE, and DORICA). Basal characteristics did not show statistically significant differences between the groups. No significant improvements in any of the variables studied were observed in the intervention enriched group compared with the control individual group. Compliance with the sessions was scarce. The satisfaction with the intervention and the acquisition of knowledge were adequate. Moreover, the benefits of both interventions were weak.",2020,No significant improvements in any of the variables studied were observed in the intervention enriched group compared with the control individual group.,"['Patients', 'With Severe Mental Disorder', '80 adult outpatients (mainly psychosis spectrum) with moderate to very high CVR', 'people with a severe mental disorder']","['Short Psychoeducational Group Intervention', 'Psychoeducational interventions']","['healthy habits regarding cardiovascular risk (CVR', 'CVR factors and indexes (REGICOR, SCORE, and DORICA', 'healthy habits regarding CVR', 'Cardiovascular Risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",80.0,0.0565276,No significant improvements in any of the variables studied were observed in the intervention enriched group compared with the control individual group.,"[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Torralbas-Ortega', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Paños-Martínez', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Patró-Moncunill', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Angel Maria', 'Initials': 'AM', 'LastName': 'Santiago-Barragán', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Cobo', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Escayola-Maranges', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Granero-Lázaro', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Marti-Mestre', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001081']
1066,30591380,"Protein bioavailability of Wolffia globosa duckweed, a novel aquatic plant - A randomized controlled trial.","BACKGROUND & AIMS


While the world is extensively looking for alternatives to animal protein sources, it is not clear which plant sources can provide the requisite full complement of essential amino acids (EAAs). Wolffia globosa is an aquatic, edible duckweed, the smallest plant on earth, and it offers all nine EAAs, dietary fibers, polyphenols, iron, zinc and B 12  vitamin. This work was designed to evaluate Mankai (a newly developed high-protein strain of W. globosa) as an optional bioavailable source of EAAs for humans (primary outcome), and of further nutrients such as vitamin B 12 , in comparison to well-established animal and plant protein sources; cheese and peas, respectively.
METHODS


36 men, subjected for 3 days to a stable diet and subsequent overnight (12 h) fast, were randomized to consume one of three iso-protein (30 g) based test-meals (soft cheese, green peas, Mankai). Blood samples were collected at 0, 30, 90 and 180 min.
RESULTS


The 3 h blood concentrations of the EAAs: histidine, phenylalanine, threonine, lysine, and tryptophan, triggered by intake of Mankai, was essentially significant as compared to baseline (p < 0.05) and similar to that of soft cheese and pea changes (p > 0.05 between groups). Although branched-chain-amino-acids (leucine/isoleucine, valine) increased significantly by Mankai within 3 h (p < 0.05 vs. baseline), the change was relatively higher for cheese as compared to Mankai or peas (p < 0.05 between groups). The increase in vitamin B 12  by Mankai was higher as compared to changes induced by either cheese (p=0.007) or peas (p=0.047, between groups).
CONCLUSIONS


Mankai may provide a high-quality substitute source for animal protein, and a potential bioavailable source of vitamin B 12 .",2019,"Although branched-chain-amino-acids (leucine/isoleucine, valine) increased significantly by Mankai within 3 h (p < 0.05 vs. baseline), the change was relatively higher for cheese as compared to Mankai or peas (p < 0.05 between groups).","['36 men, subjected for 3 days to a stable diet and subsequent overnight (12\xa0h) fast']",[],"['blood concentrations of the EAAs: histidine, phenylalanine, threonine, lysine, and tryptophan, triggered by intake of Mankai', 'Blood samples', 'vitamin B 12  by Mankai']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",[],"[{'cui': 'C1313904', 'cui_str': 'Blood concentration, test strip measurement'}, {'cui': 'C0019602', 'cui_str': 'L-histidine'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0040005', 'cui_str': 'Threonine'}, {'cui': 'C0024337', 'cui_str': 'L-lysine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}]",,0.072417,"Although branched-chain-amino-acids (leucine/isoleucine, valine) increased significantly by Mankai within 3 h (p < 0.05 vs. baseline), the change was relatively higher for cheese as compared to Mankai or peas (p < 0.05 between groups).","[{'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Yaskolka Meir', 'Affiliation': 'Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Rinott', 'Affiliation': 'Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kovsan', 'Affiliation': 'Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Novack', 'Affiliation': 'Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Thiery', 'Affiliation': 'Department of Medicine, University of Leipzig, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Ceglarek', 'Affiliation': 'Department of Medicine, University of Leipzig, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Burkhardt', 'Affiliation': 'Department of Medicine, University of Leipzig, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Willenberg', 'Affiliation': 'Department of Medicine, University of Leipzig, Germany.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Tirosh', 'Affiliation': ""Endocrinology and Diabetes Research Center at Sheba Medical Center, Israel; Harvard Medical School and Harvard T.H., Chan School of Public Health and Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Ioav', 'Initials': 'I', 'LastName': 'Cabantchik', 'Affiliation': 'Department of Biological Chemistry, Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Meir J', 'Initials': 'MJ', 'LastName': 'Stampfer', 'Affiliation': ""Harvard Medical School and Harvard T.H., Chan School of Public Health and Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: irish@bgu.ac.il.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.12.009']
1067,17629159,Colposcopists' agreement on cervical biopsy site.,"OBJECTIVE


To determine the inter-observer agreement among colposcopists on the most abnormal area of the cervix from which a biopsy would be obtained and whether any attributes predict agreement.
MATERIAL AND METHODS


Fifty cervigrams were reviewed and 72 colposcopists from five countries indicated the site to biopsy and whether an ECC should be obtained. Prior to the study, six Canadian colposcopists met to achieve consensus on the most diseased area for biopsy. Consensus was also reached on whether an ECC was indicated. For each cervigram, percent agreement was determined between each study colposcopist and the consensus. Data were analyzed to determine the attributes associated with the consensus response.
RESULTS


The percent overall agreement of the colposcopists with the consensus diagnoses had a mean of 0.70 (95% CI, 0.65-0.75). The use of ECC was most common in Canada (15% of cases). The following factors were assessed by multivariate analysis to determine their influence on individual agreement with the consensus recommendation for the site to biopsy: country, duration of practice (less than or greater than 1 year), professional group (nurse, family doctor, pathologist, gynecologist, gynecologic oncologist), expert status (recognized national/international expert vs colposcopist), and gender. No factor was significantly associated.
CONCLUSION


This international study was feasible and the level of inter-observer agreement among colposcopists on the location of the most severe lesions in cervical images is good.",2007,"The percent overall agreement of the colposcopists with the consensus diagnoses had a mean of 0.70 (95% CI, 0.65-0.75).",['Fifty cervigrams were reviewed and 72 colposcopists from five countries indicated the site to biopsy and whether an ECC should be obtained'],['ECC'],[],"[{'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}]","[{'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]",[],50.0,0.0488365,"The percent overall agreement of the colposcopists with the consensus diagnoses had a mean of 0.70 (95% CI, 0.65-0.75).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Elit', 'Affiliation': 'Department of Obstetrics and Gynecology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Julian', 'Affiliation': ''}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Sellors', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Levine', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1068,17629158,Study on the efficacy of cefaclor for the treatment of asymptomatic bacteriuria and lower urinary tract infections in pregnant women with a history of hypersensitivity to penicillin.,"PURPOSE


The purpose of this study was to compare the efficacy and safety profile of twice daily versus the conventional three daily intake of cefaclor administrated orally for five to seven days in the treatment of asymptomatic bacteriuria or acute cystitis in pregnant women with a history of hypersensitivity to penicillin.
METHODS


Between August 2003 and August 2004, 63 pregnant women with a positive urine culture and a history of suspicion of hypersensitivity to penicillin were randomly divided into two groups. The women in the first group received 500 mg of cefaclor while those in the second group received 750 mg of cefaclor for five to seven days. Laboratory and clinical results were assessed a week and a month after complettion of the therapy.
RESULTS


Final therapy (bacteriologic eradication) succeeded in 93.7% (30/32) of the first group and in 90.3% (28/31) of the second group.
CONCLUSION


Dosage of cefaclor at 750 mg is as effective as conventional cefaclor at 500 mg and better tolerated.",2007,"RESULTS


Final therapy (bacteriologic eradication) succeeded in 93.7% (30/32) of the first group and in 90.3% (28/31) of the second group.
","['pregnant women with a history of hypersensitivity to penicillin', 'Between August 2003 and August 2004, 63 pregnant women with a positive urine culture and a history of suspicion of hypersensitivity to penicillin']",['cefaclor'],"['asymptomatic bacteriuria or acute cystitis', 'tolerated', 'efficacy and safety profile']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0030842', 'cui_str': 'Antibiotics, Penicillin'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0430404', 'cui_str': 'Urine culture (procedure)'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}]","[{'cui': 'C0007537', 'cui_str': 'Cefaclor'}]","[{'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria (finding)'}, {'cui': 'C0149523', 'cui_str': 'Acute cystitis (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",63.0,0.0160508,"RESULTS


Final therapy (bacteriologic eradication) succeeded in 93.7% (30/32) of the first group and in 90.3% (28/31) of the second group.
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Stamatiou', 'Affiliation': 'Department of Urology, Tzaneion General Hospital, Piraeus, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alevizos', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Petrakos', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Lentzas', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Papathanasiou', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mariolis', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Panagopoulos', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sofras', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1069,32125716,"The consecutive controlled case series: Design, data-analytics, and reporting methods supporting the study of generality.","Single-case experimental designs (SCEDs) have proven invaluable in research and practice because they are optimal for asking many experimental questions relevant to the analysis of behavior. The consecutive controlled case series (CCCS) is a type of study in which a SCED is employed in a series of consecutively encountered cases that undergo a common procedure or share a common characteristic. Additional design elements, data-analytic, and reporting methods enable researchers to ask experimental questions relevant to the study of generality of procedures and processes. The current paper discusses the CCCS methodologies, including the retrospective, prospective, and randomized CCCS. These methodologies can be applied to examine the generality of clinical procedures (including their general efficacy, the limits of their generality, and variables that may mediate generality); study the epidemiology and phenomenology of clinical problems; and compare the efficacy of 2 clinical procedures within a randomized controlled trial combining SCEDs with randomized group designs.",2020,"These methodologies can be applied to examine the generality of clinical procedures (including their general efficacy, the limits of their generality, and variables that may mediate generality); study the epidemiology and phenomenology of clinical problems; and compare the efficacy 2 clinical procedures within a randomized controlled trial combining SCEDs with randomized group designs.",[],[],[],[],[],[],,0.0290162,"These methodologies can be applied to examine the generality of clinical procedures (including their general efficacy, the limits of their generality, and variables that may mediate generality); study the epidemiology and phenomenology of clinical problems; and compare the efficacy 2 clinical procedures within a randomized controlled trial combining SCEDs with randomized group designs.","[{'ForeName': 'Louis P', 'Initials': 'LP', 'LastName': 'Hagopian', 'Affiliation': 'Kennedy Krieger Institute.'}]",Journal of applied behavior analysis,['10.1002/jaba.691']
1070,17629162,Effects of micronized purified flavonoid fraction (Daflon) on pelvic pain in women with laparoscopically diagnosed pelvic congestion syndrome: a randomized crossover trial.,"BACKGROUND


We evaluated the effects of daflon, a venomimetic agent that regulates the circulatory tonus of the venous system, on pelvic pain and investigated the role of enlarged veins in the pathophysiology of pelvic congestion syndrome.
METHODS


Twenty women (age 28-35 yrs) with chronic pelvic pain were diagnosed with the syndrome at laparoscopy. They all had prominent broad ligaments and ovarian veins without other pathologies such as endometriosis to explain the etiology of pelvic pain. Ten women were randomized in a fashion to receive 500 mg of Daflon twice/daily for six months, and ten a vitamin pill for placebo effect; they were crossed over for another six months.
RESULTS


At the end of the third month, the frequency and severity of pelvic symptoms began to decrease with daflon compared with the pretreatment and vitamin arm. The mean scores were significantly less at the end of six months, respectively, p < 0.05.
CONCLUSIONS


Pharmacologic enhancement of venous tonus may restore pelvic circulation and relieve pelvic symptomatology.",2007,"The mean scores were significantly less at the end of six months, respectively, p < 0.05.
","['Ten women', 'women with laparoscopically diagnosed pelvic congestion syndrome', 'Twenty women (age 28-35 yrs) with chronic pelvic pain were diagnosed with the syndrome at laparoscopy']","['micronized purified flavonoid fraction (Daflon', 'vitamin pill for placebo']","['mean scores', 'frequency and severity of pelvic symptoms', 'pelvic pain']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0152078', 'cui_str': 'Pelvic congestion syndrome (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}]","[{'cui': 'C0596577', 'cui_str': 'Flavonoids'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0215217', 'cui_str': 'Daflon'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}]",10.0,0.0610077,"The mean scores were significantly less at the end of six months, respectively, p < 0.05.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Simsek', 'Affiliation': 'Department of Obstetrics and Gynecology, Akdeniz University, Antalya, Turkey.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Burak', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Taskin', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1071,17629164,Labor induction at term: a comparison of the effects of 50 microg and 25 microg vaginal misoprostol.,"PURPOSE OF INVESTIGATION


To compare the effects of 50 microg of vaginal misoprostol with 25 microg for labor induction at term.
METHODS


One hundred and forty-seven pregnant women with indications for labor induction and cervical Bishop's score of < or = 6 were randomly assigned to receive either 50 microg (n = 74) or 25 microg (n = 73) of vaginal misoprostol every four hours until either a Bishop's score of > or = 8 or adequate uterine contraction frequency had been achieved. Induction-to-vaginal-delivery time was considered the primary outcome measure.
RESULTS


Mean induction-to-vaginal-delivery time was significantly shorter in the 50-microg group than in the 25-microg group (526 +/- 141 min vs 745 +/- 218 min, respectively); oxytocin was administered to 65.8% of the patients in the 25-microg group and to 35.1% in the 50-microg group (p < .05). The incidence of tachysystole was significantly higher in the 50-microg group than in the 25-microg group (12% vs 2.7%, p < .05). We found no statistically significant difference between the two groups with respect to the rate of primary cesarean section, incidence of hyperstimulation syndrome, or neonatal outcome (p > .05).
CONCLUSION


Fifty micrograms of vaginally administered misoprostol is an effective and inexpensive means of inducing labor at term. Uterine tachysystole may be associated more frequently with a 50-microg dose of vaginal misoprostol than with a 25-microg dose. Clinicians must accurately document the frequency and intensity of uterine contractions before every 50-microg dose of misoprostol is administered.",2007,"We found no statistically significant difference between the two groups with respect to the rate of primary cesarean section, incidence of hyperstimulation syndrome, or neonatal outcome (p > .05).
","[""One hundred and forty-seven pregnant women with indications for labor induction and cervical Bishop's score of < or = 6""]","['50 microg and 25 microg vaginal misoprostol', 'oxytocin', 'misoprostol', 'vaginal misoprostol']","['incidence of tachysystole', 'Mean induction-to-vaginal-delivery time', 'rate of primary cesarean section, incidence of hyperstimulation syndrome, or neonatal outcome']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]",147.0,0.0779198,"We found no statistically significant difference between the two groups with respect to the rate of primary cesarean section, incidence of hyperstimulation syndrome, or neonatal outcome (p > .05).
","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Eroglu', 'Affiliation': 'Department of Obstetrics and Gynecology, Baskent University, Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Oktem', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Yanik', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kuscu', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1072,30598384,The effect of Atlantic salmon consumption on the cognitive performance of preschool children - A randomized controlled trial.,"BACKGROUND AND AIMS


Long chain polyunsaturated n-3 fatty acids (LC-PUFA) are of functional and structural importance for brain development. Observational studies have shown positive relations between fatty fish consumption and cognitive performance in children, but Results from intervention studies using supplementary n-3 LC-PUFA are conflicting. Salmon is a good source of n-3 LC-PUFA, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). We tested the hypothesis that an increased dietary salmon intake results in better cognitive outcomes than a meat based diet.
METHODS


Children (n = 205, age 4-6 years) in this trial were individually randomized to eating meals containing farmed Atlantic salmon or meat three times weekly for 16 weeks. Pre- and post-intervention a cognitive test (Wechsler Preschool and Primary Scale of Intelligence, 3rd edition, WPPSI-III) and a fine-motor coordination test (Nine Hole Peg Test, 9-HPT) were performed. Biochemical analyses included glycerophospholipid fatty acid profiles in plasma and cheek cells, serum 25-hydroxyvitamin D, and urinary iodine concentration. Dietary intake before and during the study were determined using food frequency questionnaires.
RESULTS


Intakes of EPA, DHA, vitamin D and iodine were higher in the salmon than the meat group, but on biomarker level only EPA and DHA increased significantly in the salmon group compared to the meat group (p < 0.001). In general linear models no significant differences between the intervention groups were found in the scale scores of the WPPSI-III tests and the 9-HPT. In analyses of the raw scores, the salmon group showed significantly better improvement in two of the eight raw scores compared to the meat group (symbol search p = 0.038, picture concepts p = 0.047).
CONCLUSIONS


Intake of farmed Atlantic salmon led to a greater increase of the raw scores of the picture concept and symbol search subtests, while in the six other subtests raw scores were not different between the groups. This might indicate a modest positive association of salmon intake with the performance of preschool children in some subtests evaluating fluid intelligence but does not suggest an influence on global IQ development.
CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE


ClinicalTrials.gov registration number: NCT01951937.",2019,In general linear models no significant differences between the intervention groups were found in the scale scores of the WPPSI-III tests and the 9-HPT.,"['preschool children', '205, age 4-6 years', 'Children (n\xa0']","['Pre- and post-intervention', 'chain polyunsaturated n-3 fatty acids (LC-PUFA', 'Atlantic salmon consumption', 'eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA', 'eating meals containing farmed Atlantic salmon or meat three times weekly for 16 weeks']","['scale scores of the WPPSI-III tests and the 9-HPT', 'raw scores', 'biomarker level only EPA and DHA', 'Intakes of EPA, DHA, vitamin D and iodine', 'glycerophospholipid fatty acid profiles in plasma and cheek cells, serum 25-hydroxyvitamin D, and urinary iodine concentration', 'cognitive test (Wechsler Preschool and Primary Scale of Intelligence, 3rd edition, WPPSI-III) and a fine-motor coordination test (Nine Hole Peg Test, 9-HPT', 'cognitive performance']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0327949', 'cui_str': 'Salmon, Atlantic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2828074', 'cui_str': 'Wechsler Preschool and Primary Scale of Intelligence'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0162448', 'cui_str': 'Phosphoglycerides'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0007966', 'cui_str': 'Bucca'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C1299705', 'cui_str': 'Fine motor coordination'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test (assessment scale)'}]",,0.107499,In general linear models no significant differences between the intervention groups were found in the scale scores of the WPPSI-III tests and the 9-HPT.,"[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Demmelmair', 'Affiliation': ""LMU - Ludwig-Maximilians-Universität München, Div. Metabolic & Nutritional Medicine, Dr. von Hauner Children's Hospital, Univ. of Munich Medical Center, Munich, Germany.""}, {'ForeName': 'Jannike', 'Initials': 'J', 'LastName': 'Øyen', 'Affiliation': 'Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Pickert', 'Affiliation': ""LMU - Ludwig-Maximilians-Universität München, Div. Metabolic & Nutritional Medicine, Dr. von Hauner Children's Hospital, Univ. of Munich Medical Center, Munich, Germany.""}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Rauh-Pfeiffer', 'Affiliation': ""LMU - Ludwig-Maximilians-Universität München, Div. Metabolic & Nutritional Medicine, Dr. von Hauner Children's Hospital, Univ. of Munich Medical Center, Munich, Germany.""}, {'ForeName': 'Kjell Morten', 'Initials': 'KM', 'LastName': 'Stormark', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Ingvild Eide', 'Initials': 'IE', 'LastName': 'Graff', 'Affiliation': 'Institute of Marine Research, Bergen, Norway; NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Lie', 'Affiliation': 'Institute of Marine Research, Bergen, Norway; Directorate of Fisheries, Bergen, Norway.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Kjellevold', 'Affiliation': 'Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""LMU - Ludwig-Maximilians-Universität München, Div. Metabolic & Nutritional Medicine, Dr. von Hauner Children's Hospital, Univ. of Munich Medical Center, Munich, Germany. Electronic address: office.koletzko@med.uni-muenchen.de.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.11.031']
1073,32429553,Effects of Cognitive Behavioral Group Program for Mental Health Promotion of University Students.,"This study aimed to explore the effects of a group cognitive behavioral program on depression, self-esteem, and interpersonal relations among undergraduate students. A non-equivalent control group pretest-posttest design was used. A convenient sample of 37 undergraduates (18 in the experimental group and 19 in the control group) at K university located in Changwon, South Korea was used. Data were collected from February 4, 2019 to June 18, 2019. The experimental group received eight sessions of the program, which were scheduled twice a week, with each session lasting 90 min. Collected data were analyzed using a chi-square test, Fisher's exact test, independent  t -test, and repeated measures ANOVA by SPSS/WIN 23.0 (SPSS, Inc., Chicago, IL, USA). The interaction of group and time was significant, indicating that the experimental group showed an improvement in depression, self-esteem, and personal relationship compared to the control group. A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups. The study results revealed that the group cognitive behavioral program was effective in reducing depression and improving self-esteem and interpersonal relation. Therefore, the group cognitive behavioral program can be used for promoting the mental health of students as well as for preventing depression in a university setting.",2020,"A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups.","['37 undergraduates (18 in the experimental group and 19 in the control group) at K university located in Changwon, South Korea was used', 'undergraduate students', 'Mental Health Promotion of University Students', 'Data were collected from February 4, 2019 to June 18, 2019']","['Cognitive Behavioral Group Program', 'group cognitive behavioral program']","['depression and improving self-esteem and interpersonal relation', 'time interaction for depression, self-esteem, and personal relationship', 'depression, self-esteem, and interpersonal relations', 'depression, self-esteem, and personal relationship']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184645', 'cui_str': 'Mental health promotion'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0129976,"A significant group by time interaction for depression, self-esteem, and personal relationship was also found between the two groups.","[{'ForeName': 'Soojung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Kyungnam University, 7, Gyeongnamdaehak-ro, Masanhappo-gu, Changwon-si, Gyeongnam 51767, Korea.'}, {'ForeName': 'Eunjoo', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Kyungnam University, 7, Gyeongnamdaehak-ro, Masanhappo-gu, Changwon-si, Gyeongnam 51767, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17103500']
1074,16108399,Administration of recombinant human erythropoietin in patients with gynecological cancer before radical surgery.,"UNLABELLED


The purpose of this prospective study was to investigate the efficacy of preoperative administration of recombinant human erythropoietin in patients with gynecological cancer.
METHODS


The study included 38 women with gynecological cancer who were divided randomly in two groups. Study group A included 20 women with gynecological cancer who received recombinant human erythropoietin (rHuEPO) plus iron supplementation for ten days before surgery and five days postoperatively. Group B (controls) included 18 patients who received only iron supplementation for the same time period. Blood samples were obtained on days -10, -3, 0, +3, +5, +10.
RESULTS


The mean hemoglobin level was significantly higher in group A than in group B on the day of the operation and remained significantly higher postoperatively while an inverse relationship was observed for mean ferritin values in the two groups.
CONCLUSION


Preoperative administration of rHuEPO in patients with gynecological cancer seems to be effective in the blood management of these patients.",2005,"The mean hemoglobin level was significantly higher in group A than in group B on the day of the operation and remained significantly higher postoperatively while an inverse relationship was observed for mean ferritin values in the two groups.
","['patients with gynecological cancer before radical surgery', 'patients with gynecological cancer', '20 women with gynecological cancer who received', '18 patients who received only iron supplementation for the same time period', '38 women with gynecological cancer']","['recombinant human erythropoietin (rHuEPO) plus iron supplementation', 'rHuEPO', 'recombinant human erythropoietin']","['mean hemoglobin level', 'mean ferritin values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C1948053', 'cui_str': 'Time periods (qualifier value)'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",38.0,0.0217368,"The mean hemoglobin level was significantly higher in group A than in group B on the day of the operation and remained significantly higher postoperatively while an inverse relationship was observed for mean ferritin values in the two groups.
","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Dousias', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of Ioannina, Ioannina, Greece.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Stefos', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Navrozoglou', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Staikos', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ditto', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Paraskevaidis', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1075,16903245,Regression rate of clinical HPV infection of the lower genital tract during pregnancy after laser CO2 surgery.,The objective of the study was to evaluate the effects of laser CO2 surgery during pregnancy to prevent clinical HPV infection recurrence after delivery and vertical infection. A case-control study was performed on 280 pregnant women affected by clinical HPV infection treated during pregnancy with 256 women treated three months after delivery. Follow-up was performed for a minimum of three colposcopic examinations for two years. Recurrence rates were calculated considering the number of positive findings for at least one colposcopic examination confirmed by biopsy after a negative control in a year. Statistical comparison of rates was performed by chi-squared and Fisher's exact test. Recurrence rates were higher in the women treated in postpartum (p < .01) than in the group treated during gestation (p < .005). Clinical HPV infections treated during the second trimester of pregnancy showed a sensitive decrease in recurrence-rate of infection. Rarity of respiratory papillomatosis makes conclusions inconsistent for the prevention of vertical infection.,2006,Recurrence rates were higher in the women treated in postpartum (p < .01) than in the group treated during gestation (p < .005).,['280 pregnant women affected by clinical HPV infection treated during pregnancy with 256 women treated three months after delivery'],['laser CO2 surgery'],"['clinical HPV infection recurrence', 'Recurrence rates', 'recurrence-rate of infection']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1143776', 'cui_str': 'cobalt(II) bis(2,2,6,6-tetramethylheptane-3,5-dionate)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",280.0,0.0761881,Recurrence rates were higher in the women treated in postpartum (p < .01) than in the group treated during gestation (p < .005).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Frega', 'Affiliation': 'Department of Gynecology, Perinatology and Childhealth, University La Sapienza of Rome, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Baiocco', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pace', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Palazzo', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Iacovelli', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Biamontil', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moscarini', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stentella', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1076,16440820,Effects of laparoscopic tubal ligation on ovarian blood flow and steroidogenesis.,"Changes in serum ovarian hormone and gonadotrophine levels and ovarian artery blood flow rate by Doppler ultrasonography following laparoscopic tubal sterilization were evaluated. Forty-seven cases of laparoscopic tubal sterilization by electrocoagulation were included in the study. Forty-two women who used nonhormonal contraceptive methods were randomized as a control group. Serum concentrations of estradiol, FSH, LH, progesterone and bilateral ovarian artery pulsatility indexes were measured at baseline and at three, six and 12 months. In the study group, the mean value of midluteal progesterone was significantly decreased three months postoperatively 3. and bilateral ovarian artery pulsatility indexes were increased three and six months postoperatively, compared to their preoperative values. However, there was no statistical difference between bilateral ovarian PI values calculated preoperatively and at 12 months. Laparoscopic tubal ligation by electrocoagulation may temporarily cause reduced bilateral ovarian artery flow and corpus luteum dysfunction proven by low mid-luteal progesterone levels.",2005,Changes in serum ovarian hormone and gonadotrophine levels and ovarian artery blood flow rate by Doppler ultrasonography following laparoscopic tubal sterilization were evaluated.,"['Forty-two women who used nonhormonal contraceptive methods', 'Forty-seven cases of']","['Doppler ultrasonography following laparoscopic tubal sterilization', 'laparoscopic tubal ligation', 'laparoscopic tubal sterilization by electrocoagulation', 'Laparoscopic tubal ligation by electrocoagulation']","['ovarian blood flow and steroidogenesis', 'mean value of midluteal progesterone', 'bilateral ovarian artery pulsatility indexes', 'bilateral ovarian artery flow and corpus luteum dysfunction', 'Serum concentrations of estradiol, FSH, LH, progesterone and bilateral ovarian artery pulsatility indexes', 'serum ovarian hormone and gonadotrophine levels and ovarian artery blood flow rate', 'bilateral ovarian PI values']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038289', 'cui_str': 'Tubal sterilization'}, {'cui': 'C0520483', 'cui_str': 'Tubal Ligation'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0226411', 'cui_str': 'Structure of ovarian artery'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0010092', 'cui_str': 'Corpus Luteum'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C4521988', 'cui_str': 'Ovarian hormone (disposition)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",42.0,0.0420808,Changes in serum ovarian hormone and gonadotrophine levels and ovarian artery blood flow rate by Doppler ultrasonography following laparoscopic tubal sterilization were evaluated.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baloglu', 'Affiliation': 'Department of Obstetrics and Gynecology, Izmir Ataturk Education and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Uysal', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Karci', 'Affiliation': ''}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Guven', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Yavuz', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1077,31806543,"Adjuvant denosumab in early breast cancer (D-CARE): an international, multicentre, randomised, controlled, phase 3 trial.","BACKGROUND


Denosumab is a fully human monoclonal antibody that binds to, and inhibits, the receptor activator of RANKL (TNFSF11) and might affect breast cancer biology, as shown by preclinical evidence. We aimed to assess whether denosumab combined with standard-of-care adjuvant or neoadjuvant systemic therapy and locoregional treatments would increase bone metastasis-free survival in women with breast cancer.
METHOD


In this international, double-blind, randomised, placebo-controlled, phase 3 study (D-CARE), patients were recruited from 389 centres in 39 countries. We enrolled women (aged ≥ 18 years) with histologically confirmed stage II or III breast cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1. On eligibility confirmation, investigators at each site telephoned an interactive voice response system to centrally randomly assign patients (1:1) based on a fixed stratified permuted block randomisation list (block size 4) to receive either denosumab (120 mg) or matching placebo subcutaneously every 3-4 weeks, starting with neoadjuvant or adjuvant chemotherapy, for about 6 months and then every 12 weeks for a total duration of 5 years. Stratification factors were breast cancer therapy, lymph node status, hormone receptor and HER2 status, age, and geographical region. The primary endpoint was the composite endpoint of bone metastasis-free survival. This trial is registered with ClinicalTrials.gov, NCT01077154.
FINDINGS


Between June 2, 2010, and Aug 24, 2012, 4509 women were randomly assigned to receive denosumab (n=2256) or placebo (n=2253) and included in the intention-to-treat analysis. The primary analysis of the study was done when all patients had the opportunity to complete 5 years of follow-up with an analysis data cutoff date of Aug 31, 2017. The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70). The most common grade 3 or worse treatment-emergent adverse events, reported in patients who had at least one dose of the investigational product (2241 patients with denosumab vs 2218 patients with placebo), were neutropenia (340 [15%] vs 328 [15%]), febrile neutropenia (112 [5%] vs 142 [6%]), and leucopenia (62 [3%] vs 61 [3%]). Positively adjudicated osteonecrosis of the jaw occurred in 122 (5%) of 2241 patients treated with denosumab versus four (<1%) of 2218 patients treated with placebo; treatment-emergent hypocalcaemia occurred in 152 (7%) versus 82 (4%). Two treatment-related deaths occurred in the placebo group due to acute myeloid leukaemia and depressed level of consciousness.
INTERPRETATION


Despite preclinical evidence suggesting RANKL inhibition might delay bone metastasis or disease recurrence in patients with early-stage breast cancer, in this study, denosumab did not improve disease-related outcomes for women with high-risk early breast cancer.
FUNDING


Amgen.",2020,"The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70).","['enrolled women (aged ≥ 18 years) with histologically confirmed stage II or III breast cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1', 'women with breast cancer', 'patients with early-stage breast cancer', 'all patients had the opportunity to complete 5 years of follow-up with an analysis data cutoff date of Aug 31, 2017', 'early breast cancer (D-CARE', 'Between June 2, 2010, and Aug 24, 2012, 4509 women', 'patients were recruited from 389 centres in 39 countries', 'women with high-risk early breast cancer']","['Adjuvant denosumab', 'placebo', 'denosumab (120 mg) or matching placebo subcutaneously every 3-4 weeks, starting with neoadjuvant or adjuvant chemotherapy', 'denosumab combined with standard-of-care adjuvant or neoadjuvant systemic therapy and locoregional treatments', 'denosumab']","['febrile neutropenia', 'bone metastasis-free survival', 'deaths', 'acute myeloid leukaemia and depressed level of consciousness', 'neutropenia', 'composite endpoint of bone metastasis-free survival', 'emergent hypocalcaemia', 'leucopenia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0549249', 'cui_str': 'Depressed Level of Consciousness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}]",2218.0,0.71545,"The primary endpoint of bone metastasis-free survival was not significantly different between the groups (median not reached in either group; hazard ratio 0·97, 95% CI 0·82-1·14; p=0·70).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Coleman', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK. Electronic address: r.e.coleman@sheffield.ac.uk.'}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Finkelstein', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa em Oncologia, Hospital São Lucas, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigacion Sanitaria Gregorio Marañon, Ciberonc, Geicam, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Nayoya, Japan.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Hospital Pérola Byington and Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glaspy', 'Affiliation': 'UCLA School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Alvaro Montaño', 'Initials': 'AM', 'LastName': 'Periañez', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Tonkin', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Deleu', 'Affiliation': 'Oncology Center, AZ Nikolass, Sint-Niklaas, Belgium.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Crown', 'Affiliation': 'All-Ireland Co-Operative Oncology Research Group, Dublin, Ireland.'}, {'ForeName': 'Suzette', 'Initials': 'S', 'LastName': 'Delaloge', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Dai', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Jandial', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre Western Australia and School of Medicine, Curtin University, Perth, WA, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30687-4']
1078,31520301,Behavioural and psychological pretreatment predictors of short- and long-term weight loss among women with overweight and obesity.,"PURPOSE


This study aims at identifying behavioural and psychological pretreatment predictors of 12- and 36-month weight loss in women with overweight/obesity enrolled in a behavioural weight management intervention.
METHODS


A sample of 221 women participated in a randomized controlled trial on weight management (n 12 month  = 184; n 36 month  = 156). Multiple linear regressions were used to identify pretreatment predictors of successful weight loss, separately for intervention and control groups. Completers-only and baseline observation carried forward analyses were performed. This study is a secondary analysis of data from the 'Promotion of Exercise and Health in Obesity' randomized controlled trial.
RESULTS


Fewer weight loss attempts in the last year positively predicted weight loss at 12 months in the intervention group, explaining 6% of the variance. At 36 months, in the intervention group, 20.2% of the variance in weight change was explained by lower eating disinhibition and higher weight-related quality of life in completers-only analyses, while baseline observation carried forward analyses explained only 9.8% of the variance in weight change via higher self-esteem and lower weight loss expectations. In the control group, higher exercise self-efficacy and a more internal weight locus of control predicted weight loss at 36 months, explaining 13.9% of the variance (completers-only analyses).
CONCLUSIONS


Previous weight loss attempts were identified as the most efficient pretreatment predictor of 12-month weight loss. Eating disinhibition, weight-related quality of life, self-esteem, weight loss expectations, exercise self-efficacy, and weight locus of control seem to be key factors for long-term success.
LEVEL OF EVIDENCE


Level I, randomized controlled trial.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier NCT00513084.",2020,"In the control group, higher exercise self-efficacy and a more internal weight locus of control predicted weight loss at 36 months, explaining 13.9% of the variance (completers-only analyses).
","['women with overweight and obesity', '221 women participated in a randomized controlled trial on weight management (n 12 month \u2009=\u2009184; n 36 month \u2009=\u2009156', 'women with overweight/obesity enrolled in a behavioural weight management intervention']",[],"['weight change via higher self-esteem and lower weight loss expectations', 'weight change', 'eating disinhibition and higher weight-related quality of life', 'Eating disinhibition, weight-related quality of life, self-esteem, weight loss expectations, exercise self-efficacy, and weight locus', 'weight loss', 'higher exercise self-efficacy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}]",[],"[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C2712312', 'cui_str': 'High self-esteem (finding)'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition, function (observable entity)'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",221.0,0.0673178,"In the control group, higher exercise self-efficacy and a more internal weight locus of control predicted weight loss at 36 months, explaining 13.9% of the variance (completers-only analyses).
","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Jorge', 'Affiliation': 'Self-Regulation in Physical Activity, Nutrition and Obesity Research Group (PANO-SR), Interdisciplinary Center for the Study of Human Performance (CIPER), Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, Cruz Quebrada, 1495-687, Lisbon, Portugal.'}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Santos', 'Affiliation': 'Self-Regulation in Physical Activity, Nutrition and Obesity Research Group (PANO-SR), Interdisciplinary Center for the Study of Human Performance (CIPER), Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, Cruz Quebrada, 1495-687, Lisbon, Portugal. isantos@fmh.ulisboa.pt.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Tomás', 'Affiliation': 'Self-Regulation in Physical Activity, Nutrition and Obesity Research Group (PANO-SR), Interdisciplinary Center for the Study of Human Performance (CIPER), Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, Cruz Quebrada, 1495-687, Lisbon, Portugal.'}, {'ForeName': 'Marlene N', 'Initials': 'MN', 'LastName': 'Silva', 'Affiliation': 'Self-Regulation in Physical Activity, Nutrition and Obesity Research Group (PANO-SR), Interdisciplinary Center for the Study of Human Performance (CIPER), Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, Cruz Quebrada, 1495-687, Lisbon, Portugal.'}, {'ForeName': 'Eliana V', 'Initials': 'EV', 'LastName': 'Carraça', 'Affiliation': 'Self-Regulation in Physical Activity, Nutrition and Obesity Research Group (PANO-SR), Interdisciplinary Center for the Study of Human Performance (CIPER), Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, Cruz Quebrada, 1495-687, Lisbon, Portugal.'}, {'ForeName': 'Vitor H', 'Initials': 'VH', 'LastName': 'Teixeira', 'Affiliation': 'Research Center in Physical Activity, Health and Leisure (CIAFEL), Faculty of Sports, University of Porto, Porto, Portugal.'}, {'ForeName': 'Pedro J', 'Initials': 'PJ', 'LastName': 'Teixeira', 'Affiliation': 'Self-Regulation in Physical Activity, Nutrition and Obesity Research Group (PANO-SR), Interdisciplinary Center for the Study of Human Performance (CIPER), Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, Cruz Quebrada, 1495-687, Lisbon, Portugal.'}]",Eating and weight disorders : EWD,['10.1007/s40519-019-00775-9']
1079,16903243,"Estrogen effects on the vaginal pH, flora and cytology in late postmenopause after a long period without hormone therapy.","In this report we evaluated the action of conjugated equine estrogens (CEE) on vaginal symptoms, cytology, pH, and flora in late postmenopausal women without any previous hormone therapy. The study was a randomized, double-blind, placebo-controlled trial with 48 late postmenopausal women who received placebo or unopposed CEE (0.625mg/day of CEE orally) during three months of treatment. Vaginal and sexual complaints were evaluated through daily diary cards. We analyzed vaginal changes through cytology and pH measurements. After three months of treatment, 20% of placebo-treated patients and 80% of the CEE-treated patients reported improvement in vaginal dryness and irritation. In the latter group, the vaginal cells and Lactobacillus increased and the vaginal pH decreased, without other changes in sexual complaints. We concluded that estrogen ameliorated the genital tract of late postmenopausal women without any previous hormone therapy.",2006,"In the latter group, the vaginal cells and Lactobacillus increased and the vaginal pH decreased, without other changes in sexual complaints.","['late postmenopausal women without any previous hormone therapy', '48 late postmenopausal women who received']","['placebo or unopposed CEE', 'placebo', 'conjugated equine estrogens (CEE', 'estrogen']","['vaginal dryness and irritation', 'Vaginal and sexual complaints', 'vaginal symptoms, cytology, pH, and flora', 'vaginal pH', 'vaginal pH, flora and cytology in late postmenopause', 'sexual complaints', 'vaginal cells and Lactobacillus']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}]","[{'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH (observable entity)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0206159', 'cui_str': 'Post-menopausal Period'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}]",,0.293868,"In the latter group, the vaginal cells and Lactobacillus increased and the vaginal pH decreased, without other changes in sexual complaints.","[{'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Galhardo', 'Affiliation': 'Obstetrics Department, Federal University of Mato Grosso do Sul, Escola de Medicina de Mato Grosso do Sul, Brazil.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Soares', 'Affiliation': ''}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Simões', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Haidar', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rodrigues de Lima', 'Affiliation': ''}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Baracat', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1080,16433156,Microsurgery versus laparoscopy in distal tubal obstruction hysterosalpingographically or laparoscopically investigated.,"OBJECTIVE


To compare pregnancy rates after laparotomic microsurgical or laparoscopic distal tuboplasty.
DESIGN


Two hundred and twenty-four women with infertility due to distal tubal occlusion were randomized to be treated with either laparotomy or laparoscopy from 1987 to 2001 at the Institute of Gynaecology and Obstetrics, University of Rome, ""La Sapienza"".
RESULTS


The results were evaluated taking into account the type of surgical approach, the severity of tubal damage and of adhesions. After a 24-month follow-up period, the overall pregnancy rate obtained with microsurgery was 43.7%, of which 33.3% were term pregnancies, 5.0% abortions, and 5.0% ectopic pregnancies. After laparoscopy, the overall pregnancy rate was 41.6%, of which 29.1% were term pregnancies, 8.3% abortions and 3.9% ectopic pregnancies. No significant differences was observed between the two groups in terms of fertility rate (chi-square 0.016, p = 0.9003).
CONCLUSIONS


Laparotomy plus microsurgery and laparoscopy were equally effective in restoring fertility in women with comparable tubal damage. The severity of the damage is a critical factor for the results.",2005,"No significant differences was observed between the two groups in terms of fertility rate (chi-square 0.016, p = 0.9003).
","['Two hundred and twenty-four women with infertility due to distal tubal occlusion', 'from 1987 to 2001 at the Institute of Gynaecology and Obstetrics, University of Rome, ""La Sapienza', 'women with comparable tubal damage']","['laparotomy or laparoscopy', 'Microsurgery versus laparoscopy', 'laparotomic microsurgical or laparoscopic distal tuboplasty']","['severity of tubal damage and of adhesions', 'overall pregnancy rate', 'restoring fertility', 'fertility rate', 'pregnancy rates']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041275', 'cui_str': 'Tubal Occlusion'}, {'cui': 'C0456591', 'cui_str': '1987 (qualifier value)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}]","[{'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0015912', 'cui_str': 'Fertility Rate'}]",224.0,0.0461963,"No significant differences was observed between the two groups in terms of fertility rate (chi-square 0.016, p = 0.9003).
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mossa', 'Affiliation': 'Department of Gynecological Science, Perinatology and Child Health University of Rome, La Sapienza, II School of Medicine, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Patella', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ebano', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pacifici', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mossa', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marziani', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1081,32063222,Cognitive behavior stress management during pregnancy: a randomized controlled trial.,"BACKGROUND


Pregnancy stress could lead to adverse health outcomes for both mother and child. Few studies have explored the effectiveness of stress management strategy among pregnant women.
OBJECTIVES/AIMS/HYPOTHESES


To examine the effectiveness of cognitive-behavioral stress management for pregnant women.
DESIGN


Randomized Controlled Trial.
METHODS


100 pregnant women (at 6-8 week of pregnancy) were selected by convenience sampling. Participants in the control group ( N  = 50) received routine prenatal examination and health education, while those in the intervention group ( N  = 50) received cognitive-behavioral stress management. Pregnancy Pressure Scale was measured at baseline and 39th weeks of pregnancy.
RESULTS


Pregnancy Pressure Scale score increased in both intervention and control groups. However, the score in the intervention group was significantly lower than those in the control group ( p  < 0.01).
CONCLUSIONS


Cognitive-behavioral stress managment can effectively reduce pregnant women's stress levels.
IMPACT STATEMENT


Nurses and midwives should conduct cognitive-behavioral stress management to help pregnant women reduce their stress.",2019,"However, the score in the intervention group was significantly lower than those in the control group ( p  < 0.01).","['during pregnancy', 'pregnant women', ""pregnant women's stress levels"", '100 pregnant women (at 6-8 week of pregnancy']","['Cognitive-behavioral stress managment', ' ', 'Cognitive behavior stress management', 'cognitive-behavioral stress management', 'routine prenatal examination and health education']","['adverse health outcomes', 'Pregnancy Pressure Scale', 'Pregnancy Pressure Scale score']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0018701'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",100.0,0.0613602,"However, the score in the intervention group was significantly lower than those in the control group ( p  < 0.01).","[{'ForeName': 'Jinzhi', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Nursing of School, Bengbu Medical College, Bengbu City, People's Republic of China.""}, {'ForeName': 'Dongfang', 'Initials': 'D', 'LastName': 'Shao', 'Affiliation': ""Department of Obstetrics, The First Affiliated Hospital of Bengbu Medical College, Bengbu City, People's Republic of China.""}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Faculty of Health, University of Technology, Sydney, Australia.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Obstetrics, The First Affiliated Hospital of Bengbu Medical College, Bengbu City, People's Republic of China.""}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Nursing of School, Bengbu Medical College, Bengbu City, People's Republic of China.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': 'School of Public Health & Community Medicine, University of New South Wales, Sydney, Australia.'}]",Contemporary nurse,['10.1080/10376178.2020.1729827']
1082,31810797,"Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study.","BACKGROUND


Treatment for renal cell carcinoma has been revolutionised by inhibitors of VEGF receptor. Previous studies have suggested that treatment with a VEGF receptor (VEGFR) tyrosine kinase inhibitor might be effective in patients who had previous checkpoint inhibitor therapy. Therefore, TIVO-3 was designed to compare the efficacy and safety of tivozanib (a potent and selective VEGFR inhibitor) with those of sorafenib as third-line or fourth-line therapy in patients with metastatic renal cell carcinoma.
METHODS


In this open-label, randomised, controlled trial done at 120 academic hospitals in 12 countries, we enrolled eligible patients older than 18 years with histologically or cytologically confirmed metastatic renal cell carcinoma and at least two previous systemic treatments (including at least one previous treatment with a VEGFR inhibitor), measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were excluded if they had received previous treatment with tivozanib or sorafenib. Patients were stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk category and type of previous therapy and randomised (1:1) with a complete permuted block design (block size of four) to either tivozanib 1·5 mg orally once daily in 4-week cycles or sorafenib 400 mg orally twice daily continuously. Investigators and patients were not masked to treatment. The primary endpoint was progression-free survival by independent review in the intention-to-treat population. Safety analyses were done in all patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, NCT02627963.
FINDINGS


Between May 24, 2016, and Aug 14, 2017, 350 patients were randomly assigned to receive tivozanib (175 patients) or sorafenib (175 patients). Median follow-up was 19·0 months (IQR 15·0-23·4). Median progression-free survival was significantly longer with tivozanib (5·6 months, 95% CI 5·29-7·33) than with sorafenib (3·9 months, 3·71-5·55; hazard ratio 0·73, 95% CI 0·56-0·94; p=0·016). The most common grade 3 or 4 treatment-related adverse event was hypertension (35 [20%] of 173 patients treated with tivozanib and 23 [14%] of 170 patients treated with sorafenib). Serious treatment-related adverse events occurred in 19 (11%) patients with tivozanib and in 17 (10%) patients with sorafenib. No treatment-related deaths were reported.
INTERPRETATION


Our study showed that tivozanib as third-line or fourth-line therapy improved progression-free survival and was better tolerated compared with sorafenib in patients with metastatic renal cell carcinoma.
FUNDING


AVEO Oncology.",2020,"Median progression-free survival was significantly longer with tivozanib (5·6 months, 95% CI 5·29-7·33) than with sorafenib (3·9 months, 3·71-5·55; hazard ratio 0·73, 95% CI 0·56-0·94; p=0·016).","['patients with advanced renal cell carcinoma (TIVO-3', 'patients who had previous checkpoint inhibitor therapy', 'renal cell carcinoma', 'Between May 24, 2016, and Aug 14, 2017, 350 patients', 'patients with metastatic renal cell carcinoma', '120 academic hospitals in 12 countries, we enrolled eligible patients older than 18 years with histologically or cytologically confirmed metastatic renal cell carcinoma and at least two previous systemic treatments (including at least one previous treatment with a VEGFR inhibitor), measurable disease according to the Response Evaluation Criteria in Solid Tumors version 1.1, and an Eastern Cooperative Oncology Group performance status of 0 or 1', 'Patients were stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk category and type of previous therapy and randomised (1:1) with a complete permuted block design (block size of four) to either']","['VEGF receptor (VEGFR) tyrosine kinase inhibitor', 'tivozanib', 'tivozanib 1·5 mg orally once daily in 4-week cycles or sorafenib 400 mg orally twice daily continuously', 'sorafenib', 'Tivozanib versus sorafenib', 'tivozanib or sorafenib']","['adverse events', 'progression-free survival', 'efficacy and safety', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]","[{'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2827667', 'cui_str': 'tivozanib'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",350.0,0.273877,"Median progression-free survival was significantly longer with tivozanib (5·6 months, 95% CI 5·29-7·33) than with sorafenib (3·9 months, 3·71-5·55; hazard ratio 0·73, 95% CI 0·56-0·94; p=0·016).","[{'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Hematology and Medical Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, USA. Electronic address: rinib2@ccf.org.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Kidney Cancer Program, City of Hope National Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Escudier', 'Affiliation': 'Department of Oncology Medicine, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Department of Medical Oncology, Georgetown Lombardi University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Urologic Oncology, Baylor Sammons Cancer Center-Texas Oncology, Dallas, TX, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Internal Medicine, University of Pavia Chief, Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Verzoni', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Needle', 'Affiliation': 'AVEO Oncology, Cambridge, MA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30735-1']
1083,31509796,Yoga Practices as an Alternative Training for Physical Fitness in Children With Visual Impairment.,"Physical activities provide fundamental benefits to children's health and well-being. They are vital for development and healthy life, but participation of children with visual impairment is limited. Herein, the authors report results of a 16-wk yoga program, evaluating its effects on physical fitness in children with visual impairment. Eighty-three children age 9-16 years (12.37 ± 2.19) participated in a 2-arm, single-blind wait-list-controlled study at a residential school in south India. Participants (yoga group 41, controls 42) were assessed on muscle strength, flexibility, endurance, coordination, and respiratory health. Significant improvements in physical fitness were observed after the yoga intervention (Group × Time interactions for right-hand grip strength, p < .001; sit-up, p < .001; sit and reach, p < .001; bilateral plate tapping, p < .001; and peak expiratory flow rate, p < .001). Left-hand grip strength showed main effects of time, although there were no Group × Time interactions. Results demonstrate yoga's ability to improve a wide range of physical variables in children with visual impairment.",2019,"Significant improvements in physical fitness were observed after the yoga intervention (Group × Time interactions for right-hand grip strength, p < .001; sit-up, p < .001; sit and reach, p < .001; bilateral plate tapping, p < .001; and peak expiratory flow rate, p < .001).","['children with visual impairment', 'Children With Visual Impairment', 'Eighty-three children age 9-16 years (12.37 ± 2.19) participated in a 2-arm, single-blind wait-list-controlled study at a residential school in south India']",[],"['muscle strength, flexibility, endurance, coordination, and respiratory health', 'physical fitness', 'peak expiratory flow rate', 'bilateral plate tapping']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3665347', 'cui_str': 'Visual Impairment'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]",[],"[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C1542834', 'cui_str': 'Peak expiratory flow rate (observable entity)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}]",83.0,0.0374061,"Significant improvements in physical fitness were observed after the yoga intervention (Group × Time interactions for right-hand grip strength, p < .001; sit-up, p < .001; sit and reach, p < .001; bilateral plate tapping, p < .001; and peak expiratory flow rate, p < .001).","[{'ForeName': 'Soubhagyalaxmi', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'SVYASA.'}, {'ForeName': 'Balaram', 'Initials': 'B', 'LastName': 'Pradhan', 'Affiliation': 'SVYASA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Hankey', 'Affiliation': 'SVYASA.'}]",Adapted physical activity quarterly : APAQ,['10.1123/apaq.2018-0167']
1084,31511279,"Effects of oligosaccharide-sialic acid (OS) compound on maternal-newborn gut microbiome, glucose metabolism and systematic immunity in pregnancy: protocol for a randomised controlled study.","INTRODUCTION


The gut microbiota participates in multiple human biological processes, including metabolism and immune responses. During pregnancy, the dynamics of gut microbiota is involved in physiological adaptation. The disturbed profile of microbiome is associated with maternal complications, such as gestational diabetes mellitus (GDM), which further transfers to the offspring and influence their metabolic and immunological functions in the long term. Prebiotics targeting the gut microbiota and modulating metabolic and immune functions have been shown to be effective in non-pregnant populations with metabolic syndrome. Hence, we propose the use of a prebiotic supplement, oligosaccharide-sialic acid (OS) from the first trimester until delivery in pregnant women, can benefit maternal/new-born gut microbiome, glucose metabolism and innate immunity.
METHODS AND ANALYSIS


In this prospective double-blinded randomised clinical trial, recruited singleton pregnancies will be stratified by body mass index (BMI) and randomly assigned to consume the OS preparation or placebo daily from the first trimester. At seven later time points (before and after recruitment in the first trimester, in the middle and third trimesters, before delivery, at birth and 42 days postpartum), compliance will be evaluated and/or biological samples will be collected. Along with maternal clinical information, questionnaires on lifestyle and infant development will be recorded. The primary outcomes are the effect of OS on the maternal-offspring gut microbiome and GDM incidence. The secondary outcomes are maternal glycolipid biochemical parameters, cytokine profiles, weight gain during pregnancy and infant morbidities, growth and development. The study aims to validate the effects of OS on reducing maternal morbidity within different BMI groups. The multiple dimensional dataset generated from the study includes clinical and lifestyle-related information, various biological markers and associated protective or risk factors for morbidity and prognosis. An extended follow-up through 42 days after birth could further explore the intrauterine influence on the long-term health of offspring.
ETHICS AND DISSEMINATION


This protocol has been approved by Peking University First Hospital, National Unit of Clinical Trial Ethics Committee (reference number: 164). The results are expected to be published in scientific manuscripts by 2021.
TRIAL REGISTRATION NUMBER


ChiCTR1800017192.",2019,Prebiotics targeting the gut microbiota and modulating metabolic and immune functions have been shown to be effective in non-pregnant populations with metabolic syndrome.,"['pregnancy', 'recruited singleton pregnancies', 'pregnant women']","['placebo', 'OS', 'prebiotic supplement, oligosaccharide-sialic acid (OS', 'oligosaccharide-sialic acid (OS']","['effect of OS on the maternal-offspring gut microbiome and GDM incidence', 'maternal glycolipid biochemical parameters, cytokine profiles, weight gain during pregnancy and infant morbidities, growth and development', 'maternal morbidity']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharides'}, {'cui': 'C0067762', 'cui_str': 'Sialic Acid'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0017950', 'cui_str': 'Glycolipids'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1457898', 'cui_str': 'growth & development'}]",,0.25174,Prebiotics targeting the gut microbiota and modulating metabolic and immune functions have been shown to be effective in non-pregnant populations with metabolic syndrome.,"[{'ForeName': 'Shuxian', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'OBGYN, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Peng', 'Affiliation': 'OBGYN, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Shengtang', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'OBGYN, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'OBGYN, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Huixia', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'OBGYN, Peking University First Hospital, Beijing, China jingmeima@bjmu.edu.cn yanghuixia@bjmu.edu.cn.'}, {'ForeName': 'Jingmei', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'OBGYN, Peking University First Hospital, Beijing, China jingmeima@bjmu.edu.cn yanghuixia@bjmu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2018-026583']
1085,31351829,Efficacy of a combined intervention program for the reduction of internalized stigma in people with severe mental illness.,"BACKGROUND


Internalized stigma (IS) is a key factor in the recovery, quality of life and functioning of people with severe mental illness (SMI), and effective intervention programs are needed to reduce IS in all its dimensions. The aim of this report was to design and evaluate the effectiveness of a new psychological intervention group program for the reduction of IS in people with SMI.
METHODS


A 9-session hands-on intervention program was designed with a group format in which different therapeutic techniques were combined. To evaluate the effectiveness of the program, 80 people with SMI and high levels of IS were selected and randomly assigned to one of two groups: program (n = 41, experimental group) or conventional treatment (n = 39, control group).
RESULTS


Mixed analysis of variance showed improvements in total IS and all of its dimensions (cognitive, emotional and behavioral) (p ≤ 0.01) and in depressive symptomatology (p = 0.01) in the experimental group after the treatment phase.
CONCLUSION


The results indicate that the program effectively reduces IS and its dimensions as well as other relevant associated variables in a sample of people with SMI.",2019,"Mixed analysis of variance showed improvements in total IS and all of its dimensions (cognitive, emotional and behavioral) (p ≤ 0.01) and in depressive symptomatology (p = 0.01) in the experimental group after the treatment phase.
","['80 people with SMI and high levels of IS', 'people with severe mental illness', 'people with severe mental illness (SMI']","['combined intervention program', 'new psychological intervention group program', 'conventional treatment (n\u202f=\u202f39, control group']","['depressive symptomatology', 'total IS and all of its dimensions (cognitive, emotional and behavioral', 'internalized stigma']","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",80.0,0.058756,"Mixed analysis of variance showed improvements in total IS and all of its dimensions (cognitive, emotional and behavioral) (p ≤ 0.01) and in depressive symptomatology (p = 0.01) in the experimental group after the treatment phase.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'González-Domínguez', 'Affiliation': 'School of Psychology, Department of Personality, Evaluation and Clinical Psychology, University Complutense of Madrid.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'González-Sanguino', 'Affiliation': 'School of Psychology, Department of Personality, Evaluation and Clinical Psychology, University Complutense of Madrid. Electronic address: clagon06@ucm.es.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': 'School of Psychology, Department of Personality, Evaluation and Clinical Psychology, University Complutense of Madrid.'}]",Schizophrenia research,['10.1016/j.schres.2019.07.010']
1086,32435929,Effectiveness of the clinical decision support tool ESR eGUIDE for teaching medical students the appropriate selection of imaging tests: randomized cross-over evaluation.,"OBJECTIVES


To evaluate ESR eGUIDE-the European Society of Radiology (ESR) e-Learning tool for appropriate use of diagnostic imaging modalities-for learning purposes in different clinical scenarios.
METHODS


This anonymized evaluation was performed after approval of ESR Education on Demand leadership. Forty clinical scenarios were developed in which at least one imaging modality was clinically most appropriate, and the scenarios were divided into sets 1 and 2. These sets were provided to medical students randomly assigned to group A or B to select the most appropriate imaging test for each scenario. Statistical comparisons were made within and across groups.
RESULTS


Overall, 40 medical students participated, and 31 medical students (78%) answered both sets. The number of correctly chosen imaging methods per set in these 31 paired samples was significantly higher when answered with versus without use of ESR eGUIDE (13.7 ± 2.6 questions vs. 12.1 ± 3.2, p = 0.012). Among the students in group A, who first answered set 1 without ESR eGUIDE (11.1 ± 3.2), there was significant improvement when set 2 was answered with ESR eGUIDE (14.3 ± 2.5, p = 0.013). The number of correct answers in group B did not drop when set 2 was answered without ESR eGUIDE (12.4 ± 2.6) after having answered set 1 first with ESR eGUIDE (13.0 ± 2.7, p = 0.66).
CONCLUSION


The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
KEY POINTS


• ESR eGUIDE improved the number of appropriately selected imaging modalities among medical students. • This improvement was also seen in the group of students which first selected imaging tests without ESR eGUIDE. • In the student group which used ESR eGUIDE first, appropriate selection remained stable even without the teaching tool.",2020,"The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
","['40 medical students participated, and 31 medical students (78%) answered both sets', 'teaching medical students']",[],['number of correct answers'],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039401', 'cui_str': 'Education'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",,0.0195978,"The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
","[{'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Diekhoff', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Kainberger', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Oleaga', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany. marc.dewey@charite.de.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}]",European radiology,['10.1007/s00330-020-06942-2']
1087,32433277,Enhanced Recovery after Lumbar Spine Fusion: A Randomized Controlled Trial to Assess the Quality of Patient Recovery.,"BACKGROUND


Prospective trials of enhanced recovery after spine surgery are lacking. We tested the hypothesis that an enhanced recovery pathway improves quality of recovery after one- to two-level lumbar fusion.
METHODS


A patient- and assessor-blinded trial of 56 patients randomized to enhanced recovery (17 evidence-based pre-, intra-, and postoperative care elements) or usual care was performed. The primary outcome was Quality of Recovery-40 score (40 to 200 points) at postoperative day 3. Twelve points defined the clinically important difference. Secondary outcomes included Quality of Recovery-40 at days 0 to 2, 14, and 56; time to oral intake and discharge from physical therapy; length of stay; numeric pain scores (0 to 10); opioid consumption (morphine equivalents); duration of intravenous patient-controlled analgesia use; complications; and markers of surgical stress (interleukin 6, cortisol, and C-reactive protein).
RESULTS


The analysis included 25 enhanced recovery patients and 26 usual care patients. Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference. There were no significant differences in recovery scores at days 0 (175 ± 16 vs. 162 ± 22; P = 0.059), 1 (174 ± 18 vs. 164 ± 15; P = 0.050), 2 (174 ± 18 vs. 167 ± 17; P = 0.289), 14 (184 ± 13 vs. 180 ± 12; P = 0.500), and 56 (187 ± 14 vs. 190 ± 8; P = 0.801). In the enhanced recovery group, subscores on the Quality of Recovery-40 comfort dimension were higher (longitudinal mean score difference, 4; 95% CI, 1, 7; P = 0.008); time to oral intake (-3 h; 95% CI, -6, -0.5; P = 0.010); and duration of intravenous patient-controlled analgesia (-11 h; 95% CI, -19, -6; P < 0.001) were shorter; opioid consumption was lower at day 1 (-57 mg; 95% CI, -130, -5; P = 0.030) without adversely affecting pain scores (-2; 95% CI, -3, 0; P = 0.005); and C-reactive protein was lower at day 3 (6.1; 95% CI, 3.8, 15.7 vs. 15.9; 95% CI, 6.6, 19.7; P = 0.037).
CONCLUSIONS


Statistically significant gains in early recovery were achieved by an enhanced recovery pathway. However, significant clinical impact was not demonstrated.",2020,Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference.,"['56 patients randomized to enhanced recovery (17 evidence-based pre-, intra-, and postoperative care elements) or usual care was performed', '25 enhanced recovery patients and 26 usual care patients', 'patients undergoing one- or two-level lumbar spinal fusion', 'Lumbar Spine Fusion']",[],"['pain scores', 'time to oral intake', 'shorter; opioid consumption', 'Quality of Recovery-40 comfort dimension', 'Quality of Recovery-40 at days 0 to 2, 14, and 56; time to oral intake and discharge from physical therapy; length of stay; numeric pain scores (0 to 10); opioid consumption (morphine equivalents); duration of intravenous patient-controlled analgesia use; complications; and markers of surgical stress (interleukin 6, cortisol, and C-reactive protein', 'quality of recovery', 'duration of intravenous patient-controlled analgesia', 'time to oral intake, duration of patient-controlled analgesia use, and day 1 opioid consumption', 'Quality of Recovery-40 score', 'Quality of Patient Recovery', 'recovery scores', 'C-reactive protein', 'Quality of Recovery-40 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}]",[],"[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",56.0,0.363217,Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference.,"[{'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Soffin', 'Affiliation': 'From the Departments of Anesthesiology, Critical Care and Pain Management, (E.M.S., J.D.B., A.T., M.U., C.R.G., J.A.N., I.F.A., S.G.M.) Orthopedic Surgery (R.C.H., H.-J.K., F.P.C., F.J.S.) the Biostatistics Core (H.Z.), Hospital for Special Surgery, New York, New York; and Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Beckman', 'Affiliation': ''}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Tseng', 'Affiliation': ''}, {'ForeName': 'Haoyan', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': ''}, {'ForeName': 'Russel C', 'Initials': 'RC', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Urban', 'Affiliation': ''}, {'ForeName': 'Carrie R', 'Initials': 'CR', 'LastName': 'Guheen', 'Affiliation': ''}, {'ForeName': 'Han-Jo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Cammisa', 'Affiliation': ''}, {'ForeName': 'Jemiel A', 'Initials': 'JA', 'LastName': 'Nejim', 'Affiliation': ''}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Schwab', 'Affiliation': ''}, {'ForeName': 'Isabel F', 'Initials': 'IF', 'LastName': 'Armendi', 'Affiliation': ''}, {'ForeName': 'Stavros G', 'Initials': 'SG', 'LastName': 'Memtsoudis', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003346']
1088,15491065,Tamoxifen down-regulates CaMKII messenger RNA levels in normal human breast tissue.,"Tamoxifen was proven to reduce the incidence of breast cancer by 49% in women at increased risk of the disease in the Breast Cancer Prevention Trial. In order to identify potential candidates to explain the preventive effect induced by tamoxifen on breast cancer, normal breast tissue obtained from 42 fibroadenoma patients, randomly assigned to receive placebo or tamoxifen, was analyzed by the reverse Northern blot and RT-PCR techniques. The cDNA fragments used on Northern blot membranes were generated by the Human Cancer Genome Project funded by the Ludwig Institute for Cancer Research and FAPESP (Fundação de Amparo à Pesquisa do Estado de São Paulo, Brazil). Total RNA was obtained from normal breast tissue from patients with clinical, cytological and ultrasound diagnosis of fibroadenoma. After a 50-day treatment with tamoxifen (10 or 20 mg/day) or placebo, normal breast tissue adjacent to the tumor was collected during lumpectomy with local anesthesia. One differentially expressed gene, Calcium/calmodulin-dependent protein kinase II (CaMKII), was found to be down-regulated during TAM treatment. CaMKII is an ubiquitous serine/threonine protein kinase that has been implicated in the diverse effects of hormones utilizing Ca2+ as a second messenger as well as in c-fos activation. These results indicate that the down-regulation of CaMKII induced by TAM might represent alternative or additional mechanisms of the action of this drug on cell cycle control and response to hormones in normal human breast tissue.",2004,Tamoxifen was proven to reduce the incidence of breast cancer by 49% in women at increased risk of the disease in the Breast Cancer Prevention Trial.,"['42 fibroadenoma patients', 'normal human breast tissue']","['TAM', 'placebo', 'placebo or tamoxifen', 'tamoxifen', 'Tamoxifen']","['incidence of breast cancer', 'Total RNA']","[{'cui': 'C0206650', 'cui_str': 'Fibroadenoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.0338005,Tamoxifen was proven to reduce the incidence of breast cancer by 49% in women at increased risk of the disease in the Breast Cancer Prevention Trial.,"[{'ForeName': 'I D C Guerreiro', 'Initials': 'ID', 'LastName': 'Da Silva', 'Affiliation': 'Molecular Gynecology Laboratory, Department of Gynecology, Federal University of São Paulo-Paulista School of Medicine (Brazil).'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Dias-Netto', 'Affiliation': ''}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Villanova', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Yamamoto', 'Affiliation': ''}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Baracat', 'Affiliation': ''}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Lima', 'Affiliation': ''}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Gebrim', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1089,14664413,"The immediate effect of natural plant extract, Angelica sinensis and Matricaria chamomilla (Climex) for the treatment of hot flushes during menopause. A preliminary report.","OBJECTIVE


To assess the efficiency of a medicinal herb extract preparation (Climex) for the treatment of menopausal symptoms.
METHOD


In this placebo-controlled experiment on 55 postmenopausal women who complained of hot flushes and refused hormonal therapy. The women were randomly divided into two groups, one to receive Climex (5 chewable tablets daily between meals) and the other group to receive a placebo; both groups would take the tablets for 12 weeks. The women were asked to complete a daily structured (Kupperman) questionnaire assessing the frequency and intensity of menopausal symptoms, starting one week prior to treatment to the completion of the study. All women underwent hormone profile measurements and transvaginal ultrasonography evaluation before and after treatment.
RESULTS


There was a significant difference between the study group and the control group in the decrease in number and intensity of hot flushes from baseline to completion of treatment (90-96% vs 15-25%, p < 0.001). In the study group, a response was already noted during the first month of treatment (68% +/- 2% reduction of hot flushes during the day and 74% +/- 4% during the night). There was also a marked alleviation of sleep disturbances and fatigue.
CONCLUSIONS


Treatment with Climex seems to be effective for menopausal symptoms without apparent major adverse effects. This hormone-free preparation may be used as an important modality for menopausal women with contraindications for hormone replacement therapy.",2003,"There was a significant difference between the study group and the control group in the decrease in number and intensity of hot flushes from baseline to completion of treatment (90-96% vs 15-25%, p < 0.001).","['hot flushes during menopause', 'menopausal women with contraindications for hormone replacement therapy', '55 postmenopausal women who complained of hot flushes and refused hormonal therapy']","['natural plant extract, Angelica sinensis and Matricaria chamomilla (Climex', 'placebo', 'medicinal herb extract preparation (Climex', 'Climex']","['hot flushes', 'number and intensity of hot flushes', 'transvaginal ultrasonography evaluation', 'sleep disturbances and fatigue']","[{'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0587112', 'cui_str': 'During menopause (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0032081', 'cui_str': 'Plant Extracts'}, {'cui': 'C0950081', 'cui_str': 'Angelica sinensis'}, {'cui': 'C1510478', 'cui_str': 'Matricaria chamomilla'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025125', 'cui_str': 'Medicinal Herbs'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",55.0,0.046243,"There was a significant difference between the study group and the control group in the decrease in number and intensity of hot flushes from baseline to completion of treatment (90-96% vs 15-25%, p < 0.001).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kupfersztain', 'Affiliation': 'The Central Menopause Outpatient Clinic, General Health Services of Israel, Petah Tikva District, Petah Tikva, Israel.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rotem', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fagot', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kaplan', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1090,14664421,Recombinant human erythropoietin in mildly anemic women before total hysterectomy.,"UNLABELLED


The purpose of this study was to investigate the efficacy of preoperative recombinant human erythropoietin (rHuEPO) treatment in a group of mildly anemic women.
METHODS


This randomized controlled study included 50 healthy, mildly anemic women who underwent total hysterectomy for leiomyomas. The study group (Group A) included 23 women who received rHuEPO 600 U/kg once weekly for three weeks, plus iron supplementation. The control group (Group B) included 27 women who received only iron supplementation. Blood samples were obtained on days -14, -7, 0, +3, +7 and +14.
RESULTS


An increase in preoperative mean hemoglobin concentration was noted in both groups; however, the increase was significantly higher in Group A throughout the study period. Mean reticulocyte count was also significantly higher in this group, whereas mean ferritin level was significantly lower. No postoperative transfusion was needed in Group A, whereas five women were transfused in Group B.
CONCLUSION


Rapid and persistent improvement of hematologic parameters makes the use of rHuEPO for preoperative treatment of mildly anemic women with benign uterine pathology a very interesting approach.",2003,"An increase in preoperative mean hemoglobin concentration was noted in both groups; however, the increase was significantly higher in Group A throughout the study period.","['27 women who received', 'mildly anemic women with benign uterine pathology', 'mildly anemic women before total hysterectomy', '50 healthy, mildly anemic women who underwent total hysterectomy for leiomyomas', 'mildly anemic women', '23 women who received']","['rHuEPO 600 U/kg once weekly for three weeks, plus iron supplementation', 'only iron supplementation', 'rHuEPO', 'preoperative recombinant human erythropoietin (rHuEPO', 'Recombinant human erythropoietin']","['postoperative transfusion', 'Blood samples', 'Mean reticulocyte count', 'mean ferritin level', 'preoperative mean hemoglobin concentration']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy (procedure)'}]","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1300561', 'cui_str': 'unit/kg'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte Number'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}]",50.0,0.0249712,"An increase in preoperative mean hemoglobin concentration was noted in both groups; however, the increase was significantly higher in Group A throughout the study period.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Dousias', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of Ioannina, Ioannina, Greece.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Paraskevaidis', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Dalkalitsis', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tsanadis', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Navrozoglou', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lolis', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1091,31377321,Impact of pleasure-oriented messages on food choices: is it more effective than traditional health-oriented messages to promote healthy eating?,"Some authors have suggested that eating pleasure is underused to promote healthy eating. However, little is known about the potential of pleasure-oriented messages to lead to healthier food choices. The aim of this study was to examine the effects of pleasure- and health-oriented messages on food choices made from a buffet. One hundred and ninety-eight participants (50% women), unaware of the real objective of the study, were randomized in three groups: 1) pleasure, 2) health, and 3) control. They first completed three 24 h food recalls to assess their overall diet quality using the Canadian Healthy Eating Index (C-HEI; score: 0 to 100). Thereafter, participants came to the research institute and those randomized in the ""pleasure"" and ""health"" groups read a leaflet on healthy eating, using either a pleasure or a health orientation respectively. Participants in the control group had no leaflet to read. All participants had subsequently to choose four food items in a buffet offering both healthy and unhealthy foods. Results showed a group by diet quality interaction (p = 0.02). Among participants with lower diet quality (C-HEI score below 50), those in the pleasure and health groups were more likely than participants in the control group to choose a healthier main course (prevalence ratios (PR) 1.71, 95% CI 1.12-2.62 and 1.83, 95% CI 1.21-2.77 for the pleasure and health group respectively) and a healthier beverage (PR 1.67, 95% CI 1.02-2.71 and 1.66, 95% CI 1.02-2.72, respectively). No such effect was observed among participants with higher C-HEI scores. In conclusion, our results suggest that in people with sub-optimal dietary habits, pleasure-oriented messages and traditional health messages are both useful to favor healthy main course and beverage choices.",2019,"Among participants with lower diet quality (C-HEI score below 50), those in the pleasure and health groups were more likely than participants in the control group to choose a healthier main course (prevalence ratios (PR) 1.71, 95% CI 1.12-2.62 and 1.83, 95% CI 1.21-2.77 for the pleasure and health group respectively) and a healthier beverage (PR 1.67, 95% CI 1.02-2.71 and 1.66, 95% CI 1.02-2.72, respectively).","['All participants had subsequently to choose four food items in a buffet offering both healthy and unhealthy foods', 'One hundred and ninety-eight participants (50% women']","['pleasure- and health-oriented messages', 'pleasure"" and ""health"" groups read a leaflet on healthy eating, using either a pleasure or a health orientation respectively']","['healthier beverage', 'no leaflet to read', 'food choices', 'overall diet quality using the Canadian Healthy Eating Index', 'diet quality interaction']","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0517483', 'cui_str': 'Health orientation'}]","[{'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",198.0,0.0764087,"Among participants with lower diet quality (C-HEI score below 50), those in the pleasure and health groups were more likely than participants in the control group to choose a healthier main course (prevalence ratios (PR) 1.71, 95% CI 1.12-2.62 and 1.83, 95% CI 1.21-2.77 for the pleasure and health group respectively) and a healthier beverage (PR 1.67, 95% CI 1.02-2.71 and 1.66, 95% CI 1.02-2.72, respectively).","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Trudel-Guy', 'Affiliation': ""Institute of Nutrition and Functional Foods, Laval University, 2440 boulevard Hochelaga, Québec, G1V 0A6, QC, Canada; School of Nutrition, Laval University, 2425 rue de l'Agriculture, Québec, G1V 0A6, QC, Canada. Electronic address: catherine.trudel-guy.1@ulaval.ca.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Bédard', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, 2440 boulevard Hochelaga, Québec, G1V 0A6, QC, Canada. Electronic address: alexandra.bedard.1@ulaval.ca.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Corneau', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, 2440 boulevard Hochelaga, Québec, G1V 0A6, QC, Canada. Electronic address: louise.corneau@fsaa.ulaval.ca.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Bélanger-Gravel', 'Affiliation': 'Department of Information and Communication, Laval University, 1055 avenue du Séminaire, Québec, G1V 0A6, QC, Canada; Québec Heart and Lung Institute, 2725 chemin Sainte-Foy, Québec, G1V 4G5, QC, Canada. Electronic address: ariane.belanger-gravel@com.ulaval.ca.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desroches', 'Affiliation': ""Institute of Nutrition and Functional Foods, Laval University, 2440 boulevard Hochelaga, Québec, G1V 0A6, QC, Canada; School of Nutrition, Laval University, 2425 rue de l'Agriculture, Québec, G1V 0A6, QC, Canada. Electronic address: sophie.desroches@fsaa.ulaval.ca.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bégin', 'Affiliation': 'Institute of Nutrition and Functional Foods, Laval University, 2440 boulevard Hochelaga, Québec, G1V 0A6, QC, Canada; School of Psychology, Laval University, 2325 rue des Bibliothèques, Québec, G1V 0A6, QC, Canada. Electronic address: catherine.begin@psy.ulaval.ca.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': ""Institute of Nutrition and Functional Foods, Laval University, 2440 boulevard Hochelaga, Québec, G1V 0A6, QC, Canada; School of Nutrition, Laval University, 2425 rue de l'Agriculture, Québec, G1V 0A6, QC, Canada. Electronic address: veronique.provencher@fsaa.ulaval.ca.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lemieux', 'Affiliation': ""Institute of Nutrition and Functional Foods, Laval University, 2440 boulevard Hochelaga, Québec, G1V 0A6, QC, Canada; School of Nutrition, Laval University, 2425 rue de l'Agriculture, Québec, G1V 0A6, QC, Canada. Electronic address: simone.lemieux@fsaa.ulaval.ca.""}]",Appetite,['10.1016/j.appet.2019.104392']
1092,31405721,Systematic and standardized hysteroscopic endometrial injury for treatment of recurrent implantation failure.,"RESEARCH QUESTION


To investigate the effect of hysteroscopic endometrial injury for treatment of recurrent implantation failure (RIF).
DESIGN


This prospective and randomized controlled trial included 239 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen-thawed embryo transfer cycles and were under the age of 40 years, who were randomized into two groups. The injury group (n = 124) received endometrial injury during their hysteroscopic procedure, whereas the control group (n = 115) did not. Patients who had endometrial pathologies were excluded from the study.
RESULTS


There were no statistically significant differences in duration of gonadotrophin use (8.23 versus 8.30 days), total dose of gonadotrophins (2330 versus 2338 IU), number of oocytes (7.03 versus 8.21), number of mature oocytes (5.27 versus 6.02), number of fertilized oocytes (4.19 versus 4.55), number of good-quality embryos (2.07 versus 2.43), number of embryos transferred (1.97 versus 1.93) or endometrial thickness (9.04 versus 9.35 mm) between the injury group and control group, respectively. Clinical pregnancy rates (25.8% versus 15.6%, P = 0.047), live birth rates (21.8% versus 12.2%, P = 0.049) and implantation rates (14.2% versus 8.8%, P = 0.036) were significantly different, favouring the injury group.
CONCLUSION


This study suggests that endometrial injury is beneficial in RIF patients to increase the odds of implantation, clinical pregnancy and live birth.",2019,"Clinical pregnancy rates (25.8% versus 15.6%, P = 0.047), live birth rates (21.8% versus 12.2%, P = 0.049) and implantation rates (14.2% versus 8.8%, P = 0.036) were significantly different, favouring the injury group.
","['239 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen-thawed embryo transfer cycles and were under the age of 40 years', 'Patients who had endometrial pathologies were excluded from the study', 'recurrent implantation failure (RIF', 'RIF patients', 'recurrent implantation failure']",['hysteroscopic endometrial injury'],"['number of mature oocytes', 'number of good-quality embryos', 'live birth rates', 'number of embryos transferred', 'Clinical pregnancy rates', 'number of oocytes', 'endometrial thickness', 'duration of gonadotrophin use', 'implantation rates', 'number of fertilized oocytes', 'total dose of gonadotrophins']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0449951', 'cui_str': 'Number of embryos transferred (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0546642', 'cui_str': 'Gonadotrophins'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",239.0,0.257246,"Clinical pregnancy rates (25.8% versus 15.6%, P = 0.047), live birth rates (21.8% versus 12.2%, P = 0.049) and implantation rates (14.2% versus 8.8%, P = 0.036) were significantly different, favouring the injury group.
","[{'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Gürgan', 'Affiliation': ""Gürgan Clinic Women's Health and IVF Centre, Ankara, Turkey; Bahcesehir University, Faculty of Medicine, Department of Obstetrics and Gynecology Istanbul, Turkey. Electronic address: tgurgan@gurganclinic.com.tr.""}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Kalem', 'Affiliation': ""Gürgan Clinic Women's Health and IVF Centre, Ankara, Turkey.""}, {'ForeName': 'Müberra N', 'Initials': 'MN', 'LastName': 'Kalem', 'Affiliation': 'Bahcesehir University, Faculty of Medicine, Department of Obstetrics and Gynecology Istanbul, Turkey.'}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Ruso', 'Affiliation': ""Gürgan Clinic Women's Health and IVF Centre, Ankara, Turkey; Gazi University, Faculty of Medicine, Department of Histology and Embryology, Ankara, Turkey.""}, {'ForeName': 'Moncef', 'Initials': 'M', 'LastName': 'Benkhalifa', 'Affiliation': 'Reproductive Medicine and Reproductive Genetics University Hospital and PERITOX Laboratory, Picardy Jules Verne University, Amiens, France.'}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Makrigiannakis', 'Affiliation': 'University of Crete, Medical School, Department of Obstetrics and Gynecology, Heraklion, Greece.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.02.014']
1093,32111479,"The effect of antioxidants on male factor infertility: the Males, Antioxidants, and Infertility (MOXI) randomized clinical trial.","OBJECTIVE


To determine whether antioxidants improve male fertility, as measured by semen parameters and DNA fragmentation at 3 months and pregnancy resulting in live birth after up to 6 months of treatment, among couples with male factor infertility.
DESIGN


Multicenter, double-blind, randomized, placebo-controlled trial with an internal pilot study.
SETTING


Nine fertility centers in the United States from December 2015 to December 2018.
PATIENT(S)


Men (N = 174) with sperm concentration ≤15 million/mL, motility ≤40%, normal morphology ≤4%, or DNA fragmentation >25%, and female partners who were ovulatory, ≤40 years old, and had documented tubal patency.
INTERVENTION(S)


Males randomly assigned to receive an antioxidant formulation (n = 85) containing 500 mg of vitamin C, 400 mg of vitamin E, 0.20 mg of selenium, 1,000 mg of l-carnitine, 20 mg of zinc, 1,000 μg of folic acid, 10 mg of lycopene daily, or placebo (n = 86). Treatment lasted for a minimum of 3 months and maximum of 6 months, and couples attempted to conceive naturally during the first 3 months and with clomiphene citrate with intrauterine insemination of the female partner in months 4 through 6.
MAIN OUTCOME MEASURE(S)


Primary outcome was live birth; secondary outcomes included pregnancy within 6 months of treatment. For the internal pilot, the primary outcomes were semen parameters and sperm DNA fragmentation index after 3 months of treatment.
RESULT(S)


In the Males, Antioxidants, and Infertility (MOXI) study, after 3 months of treatment, the change in sperm concentration differed between the antioxidant group (median -4.0 [interquartile range-12.0, 5.7] million/mL) and placebo group (+2.4 [-9.0, 15.5] million/mL). However, there were no statistically significant differences between the two groups for changes in sperm morphology, motility, or DNA fragmentation. Among the 66 oligospermic men at randomization, sperm concentration did not differ at 3 months between the antioxidant and control groups: 8.5 (4.8, 15.0) million/mL versus 15.0 (6.0, 24.0) million/mL. Of the 75 asthenospermic men, motility did not differ at 3 months: 34% ± 16.3% versus 36.4% ± 15.8%. Among the 44 men with high DNA fragmentation, DNA fragmentation did not differ at 3 months: 29.5% (21.6%, 36.5%) versus 28.0% (20.6%, 36.4%). In the entire cohort, cumulative live birth did not differ at 6 months between the antioxidant and placebo groups: 15% versus 24%.
CONCLUSION(S)


Antioxidants do not improve semen parameters or DNA integrity among men with male factor infertility. Although limited by sample size, this study suggests that antioxidant treatment of the male partner does not improve in vivo pregnancy or live-birth rates.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02421887.",2020,"However, there were no statistically significant differences between the two groups for changes in sperm morphology, motility, or DNA fragmentation.","['male factor infertility', 'men with male factor infertility', 'Men (N = 174) with sperm concentration ≤15 million/mL', 'Nine fertility centers in the United States from December 2015 to December\xa02018', 'couples with male factor infertility', '66 oligospermic men', '44 men with high DNA fragmentation']","['placebo', 'Antioxidants', 'antioxidants', 'clomiphene citrate', 'antioxidant formulation (n = 85) containing 500 mg of vitamin C, 400 mg of vitamin E, 0.20 mg of selenium, 1,000 mg of l-carnitine, 20 mg of zinc, 1,000 μg of folic acid, 10 mg of lycopene daily, or placebo']","['sperm concentration', 'semen parameters and sperm DNA fragmentation index', 'change in sperm concentration', 'cumulative live birth', 'DNA fragmentation', 'sperm morphology, motility, or DNA fragmentation', 'live birth; secondary outcomes included pregnancy within 6 months of treatment', 'tubal patency', 'vivo pregnancy or live-birth rates']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C1960956', 'cui_str': 'Million/mL'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0428011', 'cui_str': 'Sperm morphology (observable entity)'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",174.0,0.679034,"However, there were no statistically significant differences between the two groups for changes in sperm morphology, motility, or DNA fragmentation.","[{'ForeName': 'Anne Z', 'Initials': 'AZ', 'LastName': 'Steiner', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, North Carolina. Electronic address: anne.steiner@duke.edu.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, Health Sciences Center, University of Oklahoma, Oklahoma City, Oklahoma.'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marcelle I', 'Initials': 'MI', 'LastName': 'Cedars', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California-San Francisco, San Francisco, California.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical College of Georgia, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Krawetz', 'Affiliation': 'Department of Obstetrics and Gynecology & Center for Molecular Medicine and Genetics, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Usadi', 'Affiliation': 'Department of Reproductive Endocrinology and Infertility, Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Valerie L', 'Initials': 'VL', 'LastName': 'Baker', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University, Palo Alto, California.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Coward', 'Affiliation': 'Department of Urology, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wild', 'Affiliation': 'Department of Obstetrics and Gynecology, Health Sciences Center, University of Oklahoma, Oklahoma City, Oklahoma.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Masson', 'Affiliation': 'Department of Urology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Smith', 'Affiliation': 'Department of Urology, University of California- San Francisco, San Francisco, California.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Eisenberg', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2019.11.008']
1094,15864937,The use of tramadol and morphine for pain relief after abdominal hysterectomy.,"OBJECTIVE


The aim of this study was to determine whether the addition of a tramadol infusion to morphine patient-controlled analgesia (PCA) results in improved analgesic efficacy compared with morphine PCA alone after abdominal hysterectomy.
METHODS


Sixty patients undergoing abdominal hysterectomy were randomized into two groups, each receiving IV morphine PCA after surgery. The tramadol group received a loading dose of tramadol (1 mg/kg) at skin closure and a postoperative infusion of tramadol at 0.2 mg/kg/h. The control group received an equivalent volume of saline at skin closure and a postoperative saline infusion.
RESULTS


The addition of a tramadol infusion to morphine PCA was associated with lower pain scores, a reduction in PCA morphine requirements (27 +/- 4.6 mg vs 40.5 +/- 5.4 mg over 24 h) and improved patient satisfaction with pain relief (p < 0.05). No intergroup differences were found with regard to sedation, nausea and antiemetic use (p > 0.05).
CONCLUSION


The addition of a tramadol infusion to morphine PCA resulted in improved analgesic efficacy and reduced morphine requirements compared with morphine PCA alone after abdominal hysterectomy.",2005,"No intergroup differences were found with regard to sedation, nausea and antiemetic use (p > 0.05).
","['pain relief after abdominal hysterectomy', 'Sixty patients undergoing abdominal hysterectomy']","['morphine PCA alone', 'equivalent volume of saline at skin closure and a postoperative saline infusion', 'tramadol and morphine', 'tramadol', 'morphine PCA', 'tramadol infusion to morphine PCA', 'morphine patient-controlled analgesia (PCA']","['analgesic efficacy and reduced morphine requirements', 'sedation, nausea and antiemetic use', 'patient satisfaction with pain relief', 'analgesic efficacy', 'PCA morphine requirements', 'lower pain scores']","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",60.0,0.370854,"No intergroup differences were found with regard to sedation, nausea and antiemetic use (p > 0.05).
","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kocabas', 'Affiliation': 'Department of Anesthesiology and Reanimation, Ege University Faculty of Medicine, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Karaman', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Uysallar', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Firat', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1095,32433273,β-Galactooligosaccharide in Conjunction With Low FODMAP Diet Improves Irritable Bowel Syndrome Symptoms but Reduces Fecal Bifidobacteria.,"INTRODUCTION


The low FODMAP diet (LFD) reduces symptoms and bifidobacteria in irritable bowel syndrome (IBS). β-galactooligosaccharides (B-GOS) may reduce the symptoms and increase bifidobacteria in IBS. We investigated whether B-GOS supplementation alongside the LFD improves IBS symptoms while preventing the decline in bifidobacteria.
METHODS


We performed a randomized, placebo-controlled, 3-arm trial of 69 Rome III adult patients with IBS from secondary care in the United Kingdom. Patients were randomized to a sham diet with placebo supplement (control) or LFD supplemented with either placebo (LFD) or 1.4 g/d B-GOS (LFD/B-GOS) for 4 weeks. Gastrointestinal symptoms, fecal microbiota (fluorescent in situ hybridization and 16S rRNA sequencing), fecal short-chain fatty acids (gas-liquid chromatography) and pH (probe), and urine metabolites (H NMR) were analyzed.
RESULTS


At 4 weeks, adequate symptom relief was higher in the LFD/B-GOS group (16/24, 67%) than in the control group (7/23, 30%) (odds ratio 4.6, 95% confidence interval: 1.3-15.6; P = 0.015); Bifidobacterium concentrations (log10 cells/g dry weight) were not different between LFD and LFD/B-GOS but were lower in the LFD/B-GOS (9.49 [0.73]) than in the control (9.77 [0.41], P = 0.018). A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%). Fecal butyrate was lower in the LFD (387.3, P = 0.028) and LFD/B-GOS (346.0, P = 0.007) groups than in the control group (609.2).
DISCUSSION


The LFD combined with B-GOS prebiotic produced a greater symptom response than the sham diet plus placebo, but addition of 1.4 g/d B-GOS did not prevent the reduction of bifidobacteria. The LFD reduces fecal Actinobacteria and butyrate thus strict long-term use should not be advised.",2020,"A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%).","['69 Rome III adult patients with IBS from secondary care in the United Kingdom', 'irritable bowel syndrome (IBS']","['β-Galactooligosaccharide', 'β-galactooligosaccharides (B-GOS', 'sham diet with placebo supplement (control) or LFD supplemented with either placebo (LFD', 'Low FODMAP Diet', 'low FODMAP diet (LFD', 'LFD combined with B-GOS prebiotic', 'placebo']","['Bifidobacterium concentrations', 'Fecal butyrate', 'LFD/B-GOS', 'IBS symptoms', 'adequate symptom relief', 'Gastrointestinal symptoms, fecal microbiota (fluorescent in situ hybridization and 16S rRNA sequencing), fecal short-chain fatty acids (gas-liquid chromatography) and pH (probe), and urine metabolites (H NMR', 'reduction of bifidobacteria', 'symptom response']","[{'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0162789', 'cui_str': 'Fluorescence in situ hybridization'}, {'cui': 'C0035702', 'cui_str': '16S Ribosomal RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0008556', 'cui_str': 'Gas liquid chromatography measurement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0915586,"A proportion of Actinobacteria was lower in LFD (1.9%, P = 0.003) and LFD/B-GOS (1.8%, P < 0.001) groups than in the control group (4.2%).","[{'ForeName': 'Bridgette', 'Initials': 'B', 'LastName': 'Wilson', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Tokuwa', 'Initials': 'T', 'LastName': 'Kanno', 'Affiliation': ""King's College London, Institute of Pharmaceutical Science, London, United Kingdom.""}, {'ForeName': 'Gareth C', 'Initials': 'GC', 'LastName': 'Parkes', 'Affiliation': 'Department of Gastroenterology, Barts Health NHS Trust, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': ""Department of Gastroenterology, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': 'Mason', 'Affiliation': ""King's College London, Institute of Pharmaceutical Science, London, United Kingdom.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Irving', 'Affiliation': ""Department of Gastroenterology, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Lomer', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000641']
1096,15266766,Efficacy and safety of standard versus low-dose Femarelle (DT56a) for the treatment of menopausal symptoms.,"OBJECTIVE


In a previous study treatment with a daily standard dose of Femarelle (644 mg/day) resulted in a significant elevation in bone mineral density (BMD) while a reduced dose resulted in a decrease in BMD. The aim of the current study was to examine the efficacy and safety of the two doses of Femarelle in the treatment of menopausal symptoms.
MATERIALS AND METHODS


Eighty healthy postmenopausal women were randomly allocated to receive either the standard dose (SD) or low dose (LD) of Femarelle (644 mg/day vs 344 mg/day). A detailed medical history was taken on enrollment, followed by a physical examination, pelvic ultrasound, and sex hormone and lipid profiles. A detailed Kupperman index for each patient was completed. These measures were repeated every three months for 12 months.
RESULTS


In both groups there was a significant reduction in the Kupperman index following 12 weeks of treatment, which was sustained throughout the 12 months of treatment (p < 0.01). Seventy-six percent of the patients in the SD group reported a decrease in vasomotor symptoms and seventy eight % in the LD group (NS). This decrease was sustained following 12 months of treatment. There was no change in TSH and sex hormone levels or endometrial thickness during the study period.
CONCLUSIONS


In the current study we found that menopausal symptoms were reduced similarly by LD and SD, however for the combined treatment of menopausal symptoms and osteoporosis the standard dosage of 644 mg/day of Femarelle is needed.",2004,"In both groups there was a significant reduction in the Kupperman index following 12 weeks of treatment, which was sustained throughout the 12 months of treatment (p < 0.01).","['Eighty healthy postmenopausal women', 'menopausal symptoms']","['standard versus low-dose Femarelle (DT56a', 'standard dose (SD) or low dose (LD) of Femarelle ']","['vasomotor symptoms', 'Efficacy and safety', 'efficacy and safety', 'bone mineral density (BMD', 'Kupperman index', 'BMD', 'menopausal symptoms', 'TSH and sex hormone levels or endometrial thickness']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1312686', 'cui_str': 'Femarelle'}, {'cui': 'C1312684', 'cui_str': 'DT56a'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0036884', 'cui_str': 'Gonadal Steroid Hormones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",80.0,0.104256,"In both groups there was a significant reduction in the Kupperman index following 12 weeks of treatment, which was sustained throughout the 12 months of treatment (p < 0.01).","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Yoles', 'Affiliation': 'Menopausal Clinics, Department of Obstetrics and Gynecology, Shebht Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yogev', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Frenkel', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hirsch', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nahum', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kaplan', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1097,15266769,Preemptive meloxicam for postoperative pain relief after abdominal hysterectomy.,"OBJECTIVE


This study was conducted to evaluate the analgesic efficacy of meloxicam in abdominal hysterectomy.
METHODS


The study population consisted of 52 patients scheduled for total abdominal hysterectomy who were ASA 1 or 2 physical status female. Patients were allocated randomly to receive orally either 15 mg of meloxicam (Group M, n = 27) or placebo (Group P, n = 25) before anesthesia induction. After intravenous administration of 1.5 mg kg(-1) of tramadol, anesthesia was induced with an intravenous loading dose of 1-2 mg kg(-1) propofol. Anesthesia was maintained on intravenous infusion of propofol at 6-12 mg kg(-1) h plus tramadol at 1 mg kg(-1) h(-1), vecuronium, and a 2:1 nitrous oxide-oxygen mixture.
RESULTS


The relative propofol consumption was lower in Group M than in Group P, (p < 0.05). The time for analgesic rescue decreased in the order Group M > Group P (p < 0.01). The degree of sedation was similar between the groups (p > 0.05) and the visual analog scores (10-cm scale) and verbal rating scale data differences were present in the first 2 h only (p < 0.05). When side-effects were evaluated nausea and vomiting were found to be lower in group M than in group P (p < 0.05).
CONCLUSION


Preemptive meloxicam provided better postoperative analgesia than placebo.",2004,"When side-effects were evaluated nausea and vomiting were found to be lower in group M than in group P (p < 0.05).
","['after abdominal hysterectomy', '52 patients scheduled for total abdominal hysterectomy who were ASA 1 or 2 physical status female']","['placebo', 'vecuronium, and a 2:1 nitrous oxide-oxygen mixture', 'meloxicam', 'Preemptive meloxicam', 'propofol', 'tramadol, anesthesia', 'tramadol']","['time for analgesic rescue', 'postoperative analgesia', 'nausea and vomiting', 'degree of sedation', 'analgesic efficacy', 'relative propofol consumption', 'postoperative pain relief', 'visual analog scores (10-cm scale) and verbal rating scale data differences']","[{'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0404079', 'cui_str': 'Total abdominal hysterectomy (procedure)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242531', 'cui_str': 'Vecuronium'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale (assessment scale)'}]",52.0,0.0621994,"When side-effects were evaluated nausea and vomiting were found to be lower in group M than in group P (p < 0.05).
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Akarsu', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Ege University Hospital, Izmir, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Karaman', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Akercan', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kazandi', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Yucebilgin', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Firat', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1098,31387970,Financial Incentives to Promote Colorectal Cancer Screening: A Longitudinal Randomized Control Trial.,"BACKGROUND


Financial incentives may improve health behaviors. We tested the impact of offering financial incentives for mailed fecal immunochemical test (FIT) completion annually for 3 years.
METHODS


Patients, ages 50 to 64 years, not up-to-date with screening were randomized to receive either a mailed FIT outreach ( n  = 6,565), outreach plus $5 ( n  = 1,000), or $10 ( n  = 1,000) incentive for completion. Patients who completed the test were reinvited using the same incentive the following year, for 3 years. In year 4, patients who returned the kit in all preceding 3 years were reinvited without incentives. Primary outcome was FIT completion among patients offered any incentive versus outreach alone each year. Secondary outcomes were FIT completion for groups offered $5 versus outreach alone, $10 versus outreach alone, and $5 versus $10.
RESULTS


Year 1 FIT completion was 36.9% with incentives versus 36.2% outreach alone ( P  = 0.59) and was not statistically different for $10 (34.6%;  P  = 0.31) or $5 (39.2%;  P  = 0.070) versus outreach alone. Year 2 completion was 61.6% with incentives versus 60.8% outreach alone ( P  = 0.75) and not statistically different for $10 or $5 versus outreach alone. Year 3 completion was 79.4% with incentives versus 74.8% outreach alone ( P  = 0.080), and was higher for $10 (82.4%) versus outreach alone ( P  = 0.033), but not for $5 versus outreach alone. Completion was similar across conditions in year 4 (no incentives).
CONCLUSIONS


Offering small incentives did not increase FIT completion relative to standard outreach.
IMPACT


This was the first longitudinal study testing the impact of repeated financial incentives, and their withdrawal, on FIT completion.",2019,Year 2 completion was 61.6% with incentives vs. 60.8% outreach alone (P=0.75) and not statistically different for $10 or $5 vs. outreach alone.,"['In Year 4, patients who returned the kit in all preceding three years were re-invited without incentives', 'Colorectal Cancer Screening', 'Patients, aged 50-64 years, not up-to-date with screening']","['mailed FIT outreach (n=6,565), outreach plus $5 (n=1,000), or $10 (n=1,000) incentive for completion']",['FIT completion'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011008', 'cui_str': 'Dates'}]","[{'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}]",,0.162109,Year 2 completion was 61.6% with incentives vs. 60.8% outreach alone (P=0.75) and not statistically different for $10 or $5 vs. outreach alone.,"[{'ForeName': 'Alicea', 'Initials': 'A', 'LastName': 'Lieberman', 'Affiliation': 'Rady School of Management, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Ayelet', 'Initials': 'A', 'LastName': 'Gneezy', 'Affiliation': 'Rady School of Management, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Berry', 'Affiliation': 'University of Texas Southwestern Medical Center, Moncrief Cancer Institute, Fort Worth, Texas.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': 'University of Texas Southwestern Medical Center, Moncrief Cancer Institute, Fort Worth, Texas.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Department of Family Medicine, John Peter Smith Health Network, Fort Worth, Texas.'}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'University of Texas Southwestern Medical Center, Harold C. Simmons Cancer Center, Dallas, Texas.'}, {'ForeName': 'Bijal A', 'Initials': 'BA', 'LastName': 'Balasubramanian', 'Affiliation': 'Department of Epidemiology, Genetics, & Environmental Science, UT Health School of Public Health, Dallas, Texas.'}, {'ForeName': 'Keith E', 'Initials': 'KE', 'LastName': 'Argenbright', 'Affiliation': 'University of Texas Southwestern Medical Center, Moncrief Cancer Institute, Fort Worth, Texas.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'San Diego Veterans Affairs Healthcare System, San Diego, California. s1gupta@ucsd.edu.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-0039']
1099,18556967,Resting energy expenditure in insulin resistance falls with decompensation of insulin secretion in obese children.,"BACKGROUND


Low resting energy expenditure (REE) and respiratory quotient (RQ) have been shown in adults to predispose to obesity and diabetes mellitus.
AIM


To correlate REE and RQ in 73 obese children and young adults (body mass index [BMI] 37 +/- 10 kg/m2) with measures of insulin secretion and resistance (IR) indices, percent carbohydrate and fat oxidation, and prolactin and leptin levels.
DESIGN


During a 3-day admission, REE and RQ were determined by indirect calorimetry. Blood chemistries and oral glucose tolerance test (OGTT) were obtained, and intravenous glucose tolerance test (IVGTT) modified by tolbutamide was conducted after an overnight fast, permitting calculation of acute insulin response (AIR), insulin resistance (SiIVGTT), and disposition index (DI).
RESULTS


Patients fell into two groups according to their SiIVGTT: those with normal insulin sensitivity (NIS) and those with insulin resistance (IR). IR patients were subdivided on the basis of DI (cut-off value 0.13 min(-1)) into compensated (CIR) or decompensated (DIR) groups. CIR patients had higher RQ, REE corrected by BMI, AIR, and carbohydrate oxidation and lower fat oxidation than NIS and DIR patients. REE correlated positively with BMI, leptin, and AIR, and negatively with SiIVGTT.
CONCLUSIONS


Findings in the CIR and DIR groups support the correlation of REE with metabolic changes consistent with an increased risk of diabetes mellitus.",2008,"CIR patients had higher RQ, REE corrected by BMI, AIR, and carbohydrate oxidation and lower fat oxidation than NIS and DIR patients.","['73 obese children and young adults', 'Patients fell into two groups according to their SiIVGTT: those with normal insulin sensitivity (NIS) and those with insulin resistance (IR', 'obese children']","['Low resting energy expenditure (REE) and respiratory quotient (RQ', 'tolbutamide']","['BMI, leptin, and AIR, and negatively with SiIVGTT', 'RQ, REE corrected by BMI, AIR, and carbohydrate oxidation and lower fat oxidation', 'Blood chemistries and oral glucose tolerance test (OGTT', 'acute insulin response (AIR), insulin resistance (SiIVGTT), and disposition index (DI', 'insulin secretion and resistance (IR) indices, percent carbohydrate and fat oxidation, and prolactin and leptin levels', 'risk of diabetes mellitus']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0040374', 'cui_str': 'Tolbutamide'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0005774', 'cui_str': 'Blood Chemical Analysis'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",73.0,0.025463,"CIR patients had higher RQ, REE corrected by BMI, AIR, and carbohydrate oxidation and lower fat oxidation than NIS and DIR patients.","[{'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Ten', 'Affiliation': ""Pediatric Endocrinology Department, Infants and Children's Hospital of Brooklyn at Maimonides, Brooklyn, NY 11219, USA. Tenlana@aol.com""}, {'ForeName': 'Amrit', 'Initials': 'A', 'LastName': 'Bhangoo', 'Affiliation': ''}, {'ForeName': 'Neesha', 'Initials': 'N', 'LastName': 'Ramchandani', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vogiatzi', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'New', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lesser', 'Affiliation': ''}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Maclaren', 'Affiliation': ''}]",Journal of pediatric endocrinology & metabolism : JPEM,[]
1100,31358153,Oxymetazoline: reduction of subconjunctival hemorrhage incidence after intravitreal injections.,"OBJECTIVE


Subconjunctival hemorrhage (SCH) is an important minor side effect that might affect patient compliance to antivascular endothelial growth factor (anti-VEGF) intravitreal injection treatment (IVI). We sought to compare SCH incidence and pain score responses after topical oxymetazoline in naïve patients undergoing a single IVI of ranibizumab for diabetic macular edema.
METHODS


Prospective, randomized, double-blinded, single centre study. One hundred two patients naïve to anti-VEGF were assigned to receive either topical oxymetazoline or placebo 30 minutes before IVI. SCH incidence and area were measured by slit lamp 24 hours after, and pain was evaluated 5 minutes and 24 hours after.
RESULTS


SCH incidence was reported on 72% in control group versus 51% in oxymetazoline group (p = 0.037). Mean size of SCH was 16.82 mm 2  in control group versus 12.55 mm 2  in oxymetazoline group (p = 0.394). Prevalence of local pain in the overall study population was 60%. No significant statistical difference was achieved between groups 5 minutes or 24 hours after IVI in either pain scale evaluation.
CONCLUSION


Administration of topical oxymetazoline 30 minutes before IVI is a single, harmless, cost-effective intervention that decreases the incidence of subconjunctival hemorrhage. This may considerably improve patient treatment satisfaction and promote compliance to IVI therapy.",2019,Mean size of SCH was 16.82 mm 2  in control group versus 12.55 mm 2  in oxymetazoline group (p = 0.394).,"['naïve patients undergoing a single IVI of ranibizumab for diabetic macular edema', 'One hundred two patients naïve to anti-VEGF']","['topical oxymetazoline or placebo', 'oxymetazoline', 'Oxymetazoline', 'topical oxymetazoline']","['SCH incidence', 'pain', 'Mean size of SCH', 'local pain', 'SCH incidence and area', 'incidence of subconjunctival hemorrhage', 'SCH incidence and pain score responses', 'subconjunctival hemorrhage incidence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0030071', 'cui_str': 'Oxymetazoline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",102.0,0.0694406,Mean size of SCH was 16.82 mm 2  in control group versus 12.55 mm 2  in oxymetazoline group (p = 0.394).,"[{'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Gonzalez-Saldivar', 'Affiliation': 'Ophthalmology Unit, Fundación Hospital Nuestra Señora de la Luz, IAP, Ciudad de México, Mexico. Electronic address: gzzgerardo@hotmail.com.'}, {'ForeName': 'Ingrid Yazmin', 'Initials': 'IY', 'LastName': 'Pita-Ortiz', 'Affiliation': ""Division of Retina, University of Toronto, St. Michael's Hospital, Toronto, Ont.""}, {'ForeName': 'Erick Omar', 'Initials': 'EO', 'LastName': 'Flores-Villalobos', 'Affiliation': ""Division of Retina, University of Toronto, St. Michael's Hospital, Toronto, Ont.""}, {'ForeName': 'Jesús Noel', 'Initials': 'JN', 'LastName': 'Jaurrieta-Hinojos', 'Affiliation': ""Division of Retina, University of Toronto, St. Michael's Hospital, Toronto, Ont.""}, {'ForeName': 'Itzel', 'Initials': 'I', 'LastName': 'Espinosa-Soto', 'Affiliation': ""Division of Retina, University of Toronto, St. Michael's Hospital, Toronto, Ont.""}, {'ForeName': 'Geovanni', 'Initials': 'G', 'LastName': 'Rios-Nequis', 'Affiliation': ""Division of Retina, University of Toronto, St. Michael's Hospital, Toronto, Ont.""}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Ramirez-Estudillo', 'Affiliation': ""Division of Retina, University of Toronto, St. Michael's Hospital, Toronto, Ont.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Jimenez-Rodriguez', 'Affiliation': ""Division of Retina, University of Toronto, St. Michael's Hospital, Toronto, Ont.""}]",Canadian journal of ophthalmology. Journal canadien d'ophtalmologie,['10.1016/j.jcjo.2018.09.006']
1101,30440834,Novel tDCS montage favors lower limb motor imagery detection.,"This work studies a novel transcranial direct current stimulation (tDCS) montage to improve a brain-machine interface (BMI) lower limb motor imagery detection. The tDCS montage is composed by two anodes and one cathode. One anode is located over the motor cortex and the other one over the cerebellum. Ten healthy subjects participated in this experiment. They were randomly separated into two groups: sham, which received a fake stimulation, and active tDCS, which received a real stimulation. Each subject was experimented on five consecutive days. Results pointed out that there was a significant difference $(p < 0 .05)$ in the classification accuracy between the sham and the active tDCS group. On each of the five days of the experiment the active tDCS group achieved better accuracy results than the sham group: 4%, 10%, 10%, 9% and 7% higher respectively.",2018,Results pointed out that there was a significant difference $(p < 0 .05)$ in the classification accuracy between the sham and the active tDCS group.,['Ten healthy subjects participated in this experiment'],"['fake stimulation, and active tDCS, which received a real stimulation', 'novel transcranial direct current stimulation (tDCS) montage']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]",[],10.0,0.0278327,Results pointed out that there was a significant difference $(p < 0 .05)$ in the classification accuracy between the sham and the active tDCS group.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rodriguez-Ugarte', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ianez', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ortiz', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Azorin', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2018.8512656']
1102,30440859,Neural Modulation By Repetitive Transcranial Magnetic Stimulation (rTMS) for BCI Enhancement in Stroke Patients.,"Brain-computer interface (BCI) is a novel method for stroke rehabilitation. However, lacking of sufficient motor-related cortical activity greatly decreases the BCI performance in stroke patients. Interestingly, high-frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to increase the cortical excitability of lesioned hemisphere in stroke patients. This stimulation effect may have benefits on the enhancement of BCI decoding. This study recruited 16 stroke patients to evaluate the stimulation effect on BCI accuracy, with 8 patients were assigned to the TMS-group and the other 8 patients were assigned to the Control-group. Patients in the TMS-group underwent 12 sessions of 10-Hz TMS interventions in four consecutive weeks, whereas no stimulation was applied during this period in the Control-group. Meanwhile, three BCI evaluation sessions were carried out in one day before, one day after, and three days after the TMS intervention, separately. The results showed that the TMS intervention significantly improved the BCI accuracy from 63.5% to 74.3% in motor imagery (MI) tasks, and from 81.9% to 91.1% in motor execution (ME) tasks. This finding provides a novel method for the cure of BCI-inefficiency problem, and may facilitate the clinical application of BCI-based stroke rehabilitation.",2018,"The results showed that the TMS intervention significantly improved the BCI accuracy from 63.5% to 74.3% in motor imagery (MI) tasks, and from 81.9% to 91.1% in motor execution (ME) tasks.","['Stroke Patients', '16 stroke patients', 'stroke patients']","['TMS', 'Brain-computer interface (BCI', 'TMS intervention', 'transcranial magnetic stimulation (rTMS', 'Neural Modulation By Repetitive Transcranial Magnetic Stimulation (rTMS', '10-Hz TMS interventions']","['BCI accuracy', 'BCI performance']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3494288', 'cui_str': 'Brain-Computer Interfaces'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]",[],16.0,0.0213372,"The results showed that the TMS intervention significantly improved the BCI accuracy from 63.5% to 74.3% in motor imagery (MI) tasks, and from 81.9% to 91.1% in motor execution (ME) tasks.","[{'ForeName': 'Xiaokang', 'Initials': 'X', 'LastName': 'Shu', 'Affiliation': ''}, {'ForeName': 'Shugeng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Guohong', 'Initials': 'G', 'LastName': 'Chai', 'Affiliation': ''}, {'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': ''}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2018.8512860']
1103,31498753,"Positron Emission Tomography-Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma: Final Results of the International, Randomized Phase III HD16 Trial by the German Hodgkin Study Group.","PURPOSE


Combined-modality treatment (CMT) with 2× ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and small-field radiotherapy is standard of care for patients with early-stage favorable Hodgkin lymphoma (HL). However, the role of radiotherapy has been challenged. Positron emission tomography (PET) after 2× ABVD (PET-2) might help to predict individual outcomes and guide treatment.
METHODS


Between November 2009 and December 2015, we recruited patients age 18 to 75 years with newly diagnosed, early-stage favorable HL for this international randomized phase III trial. Patients were assigned to standard CMT of 2× ABVD and 20-Gy involved-field radiotherapy or PET-guided treatment, omitting involved-field radiotherapy after negative PET-2 (Deauville score < 3). Primary objectives were to exclude inferiority of 10% or more in 5-year progression-free survival (PFS) of ABVD alone compared with CMT in a per-protocol analysis among PET-2-negative patients (noninferiority margin for hazard ratio, 3.01) and to confirm PET-2 positivity (Deauville score ≥ 3) as a risk factor for PFS among CMT-treated patients.
RESULTS


We enrolled 1,150 patients. Median follow-up was 45 months. Among 628 PET-2-negative, per-protocol-treated patients, 5-year PFS was 93.4% (95% CI, 90.4% to 96.5%) with CMT and 86.1% (95% CI, 81.4% to 90.9%) with ABVD (difference 7.3% [95% CI, 1.6% to 13.0%]; hazard ratio, 1.78 [95% CI, 1.02 to 3.12]). Five-year overall survival was 98.1% (95% CI, 96.5% to 99.8%) with CMT and 98.4% (95% CI, 96.5% to 100.0%) with ABVD. Among 693 patients who were assigned to CMT, 5-year PFS was 93.2% (95% CI, 90.2% to 96.2%) among PET-2-negative patients and 88.4% (95% CI, 84.2% to 92.6%) in PET-2-positive patients ( P  = .047). When using the more common liver cutoff (Deauville score, 4) for PET-2 positivity, the difference was more pronounced (5-year PFS, 93.1% [95% CI, 90.7% to 95.5%]  v  80.9% [95% CI, 72.2% to 89.7%];  P  = .0011).
CONCLUSION


In early-stage favorable HL, a positive PET after two cycles ABVD indicates a high risk for treatment failure, particularly when a Deauville score of 4 is used as a cutoff for positivity. In PET-2-negative patients, radiotherapy cannot be omitted from CMT without clinically relevant loss of tumor control.",2019,"Five-year overall survival was 98.1% (95% CI, 96.5% to 99.8%) with CMT and 98.4% (95% CI, 96.5% to 100.0%) with ABVD.","['We enrolled 1,150 patients', 'Between November 2009 and December 2015', '693 patients', 'patients with early-stage favorable Hodgkin lymphoma (HL', 'Early-Stage Favorable Hodgkin Lymphoma', 'recruited patients age 18 to 75 years with newly diagnosed, early-stage favorable HL for this international randomized phase III trial']","['Positron Emission Tomography-Guided Treatment', 'Combined-modality treatment (CMT) with 2× ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and small-field radiotherapy', 'standard CMT of 2× ABVD and 20-Gy involved-field radiotherapy or PET-guided treatment, omitting involved-field radiotherapy', 'Positron emission tomography (PET', 'radiotherapy']","['5-year PFS', '5-year progression-free survival (PFS) of ABVD', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1150.0,0.269604,"Five-year overall survival was 98.1% (95% CI, 96.5% to 99.8%) with CMT and 98.4% (95% CI, 96.5% to 100.0%) with ABVD.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Goergen', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Kobe', 'Affiliation': 'Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Kuhnert', 'Affiliation': 'Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Lohri', 'Affiliation': 'Cantonal Hospital Baselland, Liestal, Switzerland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'IIIrd Medical Department, Paracelcus Medical University and Salzburg Cancer Research Institute, Salzburg, Austria.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sasse', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Topp', 'Affiliation': 'Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Erhardt', 'Initials': 'E', 'LastName': 'Schäfer', 'Affiliation': 'Dres. med. Just/Düwel/Riesenberg/Steinke/Schäfer, Studiengesellschaft, Bielefeld, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Department of Internal Medicine I, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soekler', 'Affiliation': 'University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Vogelhuber', 'Affiliation': 'Medizinische Klinik III, Universitätsklinik Regensburg, Regensburg, Germany.'}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Amsterdam University Medical Center, Vrije Universiteit, Department of Hematology, Amsterdam, Netherlands.'}, {'ForeName': 'Ulrich Bernd', 'Initials': 'UB', 'LastName': 'Keller', 'Affiliation': 'Department of Internal Medicine III, Klinikum ""Rechts der Isar"", Munich, Germany.'}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Krause', 'Affiliation': 'Department of Internal Medicine 5, Haematology/Oncology, University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Medical Oncology, Klinikum Nürnberg, Paracelsus Medical University, Nürnberg, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Maschmeyer', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Klinikum Ernst von Bergmann, Potsdam, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Thiemer', 'Affiliation': 'Clinic for Hematology, Oncology and Immunology, Philipps University, Marburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dührsen', 'Affiliation': 'Department of Haematology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Meissner', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Viardot', 'Affiliation': 'Department of Internal Medicine III, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eich', 'Affiliation': 'Department of Radiotherapy, University Hospital of Muenster, Muenster, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baues', 'Affiliation': 'Department of Radiotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Diehl', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenwald', 'Affiliation': 'Institute of Pathology, Julius Maximilian University of Würzburg and Comprehensive Cancer Center Mainfranken, Würzburg, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'von Tresckow', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Dietlein', 'Affiliation': 'Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'German Hodgkin Study Group (GHSG), Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00964']
1104,31501493,Effect of angiotensin II receptor blocker and salt supplementation on short-term blood pressure variability in type 2 diabetes.,"High blood pressure variability (BPV) has been associated with increased cardiovascular (CV) risk. The effect of dietary salt and renin-angiotensin-aldosterone system (RAAS) activity on short-term BPV in type 2 diabetes mellitus (T2DM) is not well characterised. We aimed to determine the effect of dietary salt (sodium chloride, NaCl) supplementation on 24-h mean arterial BPV (24hBPV) during angiotensin II receptor blocker (telmisartan) use and to evaluate the effects of age, sex, plasma renin activity (PRA) and serum aldosterone on 24hBPV. In a randomised, double-blind, crossover study, patients with T2DM (n = 28), treated with telmisartan received NaCl (100 mmol/24 h) or placebo capsules during 2 weeks of telmisartan. Following a 6-week washout, the protocol was repeated in reverse. 24hBPV was evaluated as a co-efficient of variation [CV (%) = mean/standard deviation] × 100). Twenty-four hour urinary sodium excretion, ambulatory BP and biochemical tests were performed at each phase. Results were analysed using a linear mixed model to generate predicted values for 24hBPV. Predicted 24hBPV was higher with telmisartan vs baseline (p = 0.01), with a trend towards reduced 24hBPV with salt (p = 0.052). Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011). In patients with T2DM, predicted 24hBPV increased from baseline with telmisartan, but there was no additional increase in predicted 24hBPV with salt supplementation. This suggests that in the short-term, salt supplementation has no apparent deleterious effects on 24hBPV. Long-term studies are required to evaluate the effect of 24hBPV on CV outcomes in patients with T2DM.",2020,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","['patients with T2DM (n\u2009=\u200928), treated with', 'type 2 diabetes', 'type 2 diabetes mellitus (T2DM', 'patients with T2DM']","['telmisartan', 'telmisartan received NaCl', '24hBPV', 'dietary salt (sodium chloride, NaCl) supplementation', 'placebo', 'angiotensin II receptor blocker and salt supplementation', 'angiotensin II receptor blocker (telmisartan', 'dietary salt and renin-angiotensin-aldosterone system (RAAS) activity']","['urinary sodium excretion, ambulatory BP and biochemical tests', 'Predicted 24hBPV', 'cardiovascular (CV) risk', '24hBPV', 'CV outcomes', 'High blood pressure variability (BPV', 'short-term blood pressure variability', 'PRA', '24-h mean arterial BPV (24hBPV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",,0.0546638,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","[{'ForeName': 'Angela X', 'Initials': 'AX', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Moran', 'Affiliation': 'Queen Elizabeth Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Libianto', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Baqar', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Callaghan"", 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Jerums', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Elif I', 'Initials': 'EI', 'LastName': 'Ekinci', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia. elif.ekinci@unimelb.edu.au.'}]",Journal of human hypertension,['10.1038/s41371-019-0238-3']
1105,31376438,Attentional bias to food varies as a function of metabolic state independent of weight status.,"Eating behaviour requires that internal metabolic changes are recognized by the central nervous system which regulates brain responses to food cues. This function may be altered in obesity. The aim of this study was to examine potential differences in neurocognitive responses to visual food cues as a function of metabolic state and weight status. A crossover study with two participant groups was conducted, one group with normal-weight (n = 20) and one group with overweight/obesity (n = 22), who completed a novel battery of neurocognitive tests assessing food-cue elicited behavior in both fasted and fed states. The test battery included a visual-dot probe task (VPT), a stimulus-response compatibility task (SRCT) and an implicit association task (IAT). Results from the VPT showed a significant main effect of metabolic state on attentional bias (F(1,40) = 9.90, p = .003, η 2 p  = .198), with participants in the fasted state showing a significantly greater attentional bias for food stimuli than in the fed state. No significant main effect of metabolic state on approach food bias, assessed via the SRCT, or implicit attitudes to food cues, assessed via the IAT, was found and overall, no difference in neurocognitive processing of food cues was demonstrated between participant groups. In the fed state, attentional bias to food cues decreases in both normal-weight controls and participants with overweight/obesity, indicating that changes in current metabolic state can be reflected in attentional processing of visual food cues independently of weight status. Neurocognitive tasks which can effectively and sensitively identify differences in food cue perception according to changes in metabolic status will be useful tools in exploring more complicated interactions between homeostatic and hedonic drives of food intake.",2019,"In the fed state, attentional bias to food cues decreases in both normal-weight controls and participants with overweight/obesity, indicating that changes in current metabolic state can be reflected in attentional processing of visual food cues independently of weight status.","['two participant groups was conducted, one group with normal-weight (n\u202f=\u202f20) and one group with overweight/obesity (n\u202f=\u202f22), who completed a novel battery of neurocognitive tests assessing food-cue elicited behavior in both fasted and fed states']",[],"['visual-dot probe task (VPT), a stimulus-response compatibility task (SRCT) and an implicit association task (IAT', 'metabolic state and weight status', 'attentional bias for food stimuli', 'metabolic state on attentional bias', 'neurocognitive processing of food cues', 'metabolic state on approach food bias, assessed via the SRCT, or implicit attitudes to food cues, assessed via the IAT']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0872227', 'cui_str': 'Neurocognitive Tests'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],"[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0210187,"In the fed state, attentional bias to food cues decreases in both normal-weight controls and participants with overweight/obesity, indicating that changes in current metabolic state can be reflected in attentional processing of visual food cues independently of weight status.","[{'ForeName': 'Nikoleta S', 'Initials': 'NS', 'LastName': 'Stamataki', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Oxford Rd, Manchester, M13 9PL, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Elliott', 'Affiliation': 'Neuroscience and Psychiatry Unit, Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Oxford Rd, Manchester, M13 9PL, UK.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'McKie', 'Affiliation': 'Medicine and Health Platform Sciences, Enabling Technologies and Infrastructure, Faculty of Biology, Medicine and Health Research & Innovation, The University of Manchester, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'McLaughlin', 'Affiliation': 'Division of Diabetes, Endocrinology & Gastroenterology, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Oxford Rd, Manchester, M13 9PL, UK. Electronic address: john.mclaughlin@manchester.ac.uk.'}]",Appetite,['10.1016/j.appet.2019.104388']
1106,18655528,Treatment of childhood obesity in obese families.,"BACKGROUND


Parental obesity reduces the likelihood of a multidisciplinary childhood obesity program to succeed, suggesting that special family-based interventions should be constructed for obese children from obese families.
AIM


To examine the effects of an intense combined 3-month familial dietary-behavioral-physical activity intervention for a subgroup of obese children (BMI >95th percentile) from obese families (parental BMI >27 kg/m2) compared to a control group of obese children and obese parents who did not participate in the combined intervention.
CHILDREN


Twenty-two obese children were randomly assigned to the intervention (n = 11) or control (n = 11) group. Anthropometric measurements, body composition, dietary and activity habits and fitness levels were measured before and at the end of a 3-month intervention.
RESULTS


The intervention led to a significant difference in change in body weight (-0.2 +/- 0.3 vs 1.7 +/- 0.6 kg; p <0.05), BMI percentiles (-1.4 +/- 0.5 vs -0.1 +/- 0.2%; p <0.05), and to a decrease in screen (television and computer) time (-2.2 +/- 0.6 vs 0.1 +/- 0.3 h/day; p <0.05) in the intervention group compared to the controls. In addition, the intervention led to a significant improvement in fitness level determined by endurance time (181 +/- 30 vs 26 +/- 63 seconds in the intervention vs control group, respectively; p <0.05).
CONCLUSION


Obese children from obese families pose a therapeutic challenge to health care providers. Intense family-oriented multidisciplinary weight management intervention should be designed for treatment in this unique population.",2008,"0.2%; p <0.05), and to a decrease in screen (television and computer) time (-2.2 +/- 0.6 vs 0.1 +/-","['obese children (BMI >95th percentile) from obese families (parental BMI >27 kg/m2) compared to a control group of obese children and obese parents who did not participate in the combined intervention', 'obese children from obese families', 'Obese children from obese families', 'childhood obesity in obese families', 'CHILDREN\n\n\nTwenty-two obese children']",['intense combined 3-month familial dietary-behavioral-physical activity intervention'],"['body weight', 'screen (television and computer) time', 'Anthropometric measurements, body composition, dietary and activity habits and fitness levels', 'fitness level determined by endurance time', 'BMI percentiles']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",22.0,0.0238898,"0.2%; p <0.05), and to a decrease in screen (television and computer) time (-2.2 +/- 0.6 vs 0.1 +/-","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Nemet', 'Affiliation': 'Child Health & Sports Center, Department of Pediatrics, Meir General Hospital, Kfar Saba, Israel. dnemet@gmail.com'}, {'ForeName': 'Neomi', 'Initials': 'N', 'LastName': 'Barzilay-Teeni', 'Affiliation': ''}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Eliakim', 'Affiliation': ''}]",Journal of pediatric endocrinology & metabolism : JPEM,[]
1107,31442486,How does the embodied metaphor affect creative thinking?,"This study aimed to explore the neural correlates of the embodied metaphor ""breaking the rules"" and how it affects creativity by using functional near-infrared spectroscopy (fNIRS). To embody the metaphor ""breaking the rules,"" we created a circumstance in which participants can experience ""breaking the walls"" through virtual reality (VR) technology. Participants were randomly assigned to three conditions: the ""break-wall"" condition, where they broke the walls to move forward; the ""auto-wall"" condition, where the barrier wall opened automatically; and the ""no-wall"" condition, where no barrier walls appeared. While walking in the virtual scenes, participants were asked to solve a creativity-demanding problem and to wear the fNIRS device to record their neural activities. It was found that participants showed better creative performance in the ""break-wall"" condition than in the other conditions. Weaker activations were found in the frontopolar cortex, the dorsolateral prefrontal cortex, and the somatosensory association cortex under the ""break-wall"" condition, which may be associated with rule-breaking behaviors, creative performance, and sense of embodiment. These findings may indicate that physical actions of ""breaking the wall"" activate the conceptual metaphor of ""breaking the rules,"" which triggers brain activities related to rule-breaking, thus affecting creative performance.",2019,"Weaker activations were found in the frontopolar cortex, the dorsolateral prefrontal cortex, and the somatosensory association cortex under the ""break-wall"" condition, which may be associated with rule-breaking behaviors, creative performance, and sense of embodiment.",[],"['break-wall"" condition, where they broke the walls to move forward; the ""auto-wall"" condition, where the barrier wall opened automatically; and the ""no-wall"" condition']",['creative performance'],[],"[{'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],,0.018667,"Weaker activations were found in the frontopolar cortex, the dorsolateral prefrontal cortex, and the somatosensory association cortex under the ""break-wall"" condition, which may be associated with rule-breaking behaviors, creative performance, and sense of embodiment.","[{'ForeName': 'Xinyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Yingyao', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Kelong', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Xinuo', 'Initials': 'X', 'LastName': 'Qiao', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China. Electronic address: nhao@psy.ecnu.edu.cn.'}]",NeuroImage,['10.1016/j.neuroimage.2019.116114']
1108,31888701,"Zwakala Ndoda: a cluster and individually randomized trial aimed at improving testing, linkage, and adherence to treatment for hard-to reach men in KwaZulu-Natal, South Africa.","BACKGROUND


Men in sub-Saharan Africa are less likely than women to get tested for HIV, less likely to present for treatment, less likely to be maintained in treatment, more likely to have detectable viral load, more likely to transmit HIV with unprotected intercourse, and more likely to progress to AIDS and die sooner from HIV. The ultimate objective of this research is to provide evidence-based strategies to improve HIV testing and treatment of HIV-infected men.
METHODS


This study is being conducted in the Greater Edendale Area and Vulindlela region in KwaZulu-Natal, South Africa. It is a two-stage design of a cluster-randomized trial and an individual randomized trial to test how structural and individual-level interventions address the demand-side factors that affect HIV testing and treatment for hard-to reach, high-risk men. It combines male-focused mobilization, community-based mobile HIV testing services, and a small incentive to determine if the strategies singly and in combination can result in more men diagnosed with HIV, and more men linked to and maintained in care with undetectable viral load.
DISCUSSION


A priority for sub-Sahara Africa is developing and evaluating novel and cost-effective strategies for identifying hard-to-reach groups such as men, linking them to HIV testing and care services, and maintaining them in care to the point of viral suppression. We propose a combination prevention intervention that addresses men's individual, interpersonal, and structural barriers to testing and care. This includes male-led mobilization to encourage uptake of testing and treatment, male-focused testing venues, male-only counselors, developing counseling models that are flexible and responsive to men, and strategies for adhering to clinic visits without missing work and navigating the healthcare system. By thoughtfully combining male-focused mobilization, and testing and addressing some of the barriers to male engagement with health facilities, this study hopes to add to the growing evidence base about how to reach, test, link, and maintain a hard-to-reach group such as men in HIV treatment and care services.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03794245. Registered on 4 January 2019.",2019,"By thoughtfully combining male-focused mobilization, and testing and addressing some of the barriers to male engagement with health facilities, this study hopes to add to the growing evidence base about how to reach, test, link, and maintain a hard-to-reach group such as men in HIV treatment and care services.
","['Greater Edendale Area and Vulindlela region in KwaZulu-Natal, South Africa', 'HIV-infected men', 'hard-to reach, high-risk men', 'hard-to reach men in KwaZulu-Natal, South Africa']",['combination prevention intervention'],[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",[],,0.0595357,"By thoughtfully combining male-focused mobilization, and testing and addressing some of the barriers to male engagement with health facilities, this study hopes to add to the growing evidence base about how to reach, test, link, and maintain a hard-to-reach group such as men in HIV treatment and care services.
","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'van Rooyen', 'Affiliation': 'Human Sciences Research Council, Durban, South Africa.'}, {'ForeName': 'Tawanda', 'Initials': 'T', 'LastName': 'Makusha', 'Affiliation': 'Human Sciences Research Council, Durban, South Africa. tmakusha@hsrc.ac.za.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Joseph', 'Affiliation': 'Human Sciences Research Council, Durban, South Africa.'}, {'ForeName': 'Thulani', 'Initials': 'T', 'LastName': 'Ngubane', 'Affiliation': 'Human Sciences Research Council, Durban, South Africa.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kulich', 'Affiliation': 'Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sweat', 'Affiliation': 'The Medical University of South Carolina, Charleston, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Coates', 'Affiliation': 'University of California Global Health Institute, San Francisco, USA.'}]",Trials,['10.1186/s13063-019-3908-0']
1109,31278117,Muscle-targeted nutritional support for rehabilitation in patients with parkinsonian syndrome.,"OBJECTIVE


We evaluated the efficacy of muscle-targeted nutritional support on the functional outcomes of multidisciplinary intensive rehabilitation treatment (MIRT) in patients with Parkinson disease (PD) or parkinsonism.
METHODS


We conducted a pragmatic, bicentric, randomized (1:1), assessor-blind controlled trial (Protein, Leucine and Vitamin D Enhancing Rehabilitation [PRO-LEADER]; April 2017 to January 2018) in cognitively intact patients with PD or parkinsonism and undergoing a 30-day MIRT. Patients (n = 150) received a standard hospital diet with or without a whey protein-based nutritional supplement enriched with leucine and vitamin D twice daily. The primary efficacy endpoint was the increase in the distance walked during a 6-minute walking test (6MWT). Secondary endpoints were changes in 4-meter walking speed, Timed Up and Go test (TUG), Berg balance scale, handgrip strength, Self-assessment Parkinson's Disease Disability Scale, body weight, and skeletal muscle mass (SMM).
RESULTS


Nutritional support resulted in greater increase in the distance walked during 6MWT (mean 69.6 meters [95% confidence interval (CI) 60.7-78.6]) than no support (51.8 meters [95% CI 37.0-66.7]): center-adjusted mean difference, 18.1 meters (95% CI 0.9-35.3) ( p  = 0.039). Further adjustment for changes in dopaminergic therapy and SMM yielded consistent results: mean difference, 18.0 meters (95% CI 0.7-35.2) ( p  = 0.043). A meaningful effect was also found for the following secondary endpoints: 4-meter walking speed ( p  = 0.032), TUG ( p  = 0.046), SMM, and SMM index ( p  = 0.029). Six patients discontinued the nutritional therapy due to mild side effects.
CONCLUSION


The consumption of a whey protein-based nutritional formula enriched with leucine and vitamin D with MIRT improved lower extremity function and preserved muscle mass in patients with PD or parkinsonism.Clinicaltrials.gov IDENTIFIER: NCT03124277.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that for patients with parkinsonism undergoing intensive rehabilitation, a whey protein-based nutritional formula enriched with leucine and vitamin D increased distance walked on the 6MWT.",2019,"A meaningful effect was also found for the following secondary endpoints: 4-meter walking speed ( p  = 0.032), TUG ( p  = 0.046), SMM, and SMM index ( p  = 0.029).","['patients with PD or parkinsonism', 'patients with parkinsonism undergoing intensive rehabilitation, a whey protein-based nutritional formula enriched with', 'patients with parkinsonian syndrome', 'cognitively intact patients with PD or parkinsonism and undergoing a 30-day MIRT', 'patients with Parkinson disease (PD) or parkinsonism', 'Patients (n = 150']","['Leucine and Vitamin D Enhancing Rehabilitation [PRO-LEADER', 'Muscle-targeted nutritional support for rehabilitation', 'muscle-targeted nutritional support', 'standard hospital diet with or without a whey protein-based nutritional supplement enriched with leucine and vitamin D twice daily', 'leucine and vitamin D', 'multidisciplinary intensive rehabilitation treatment (MIRT', 'leucine and vitamin D with MIRT']","['distance walked during 6MWT', ""changes in 4-meter walking speed, Timed Up and Go test (TUG), Berg balance scale, handgrip strength, Self-assessment Parkinson's Disease Disability Scale, body weight, and skeletal muscle mass (SMM"", 'distance walked during a 6-minute walking test (6MWT', 'lower extremity function', 'SMM, and SMM index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0718401,"A meaningful effect was also found for the following secondary endpoints: 4-meter walking speed ( p  = 0.032), TUG ( p  = 0.046), SMM, and SMM index ( p  = 0.029).","[{'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Barichella', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Cereda', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy. e.cereda@smatteo.pv.it.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Pinelli', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Iorio', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Caroli', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Masiero', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ferri', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Cassani', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Bolliri', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Caronni', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Maggio', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Ortelli', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Ferrazzoli', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Maras', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Riboldazzi', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Frazzitta', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Pezzoli', 'Affiliation': 'From the Parkinson Institute (M.B., D.C., I.M., V.F., E.C., C.B., S.C., G. Pezzoli), ASST G.Pini-CTO, ex ICP, Milan; Clinical Nutrition and Dietetics Unit (E.C.), Fondazione IRCCS Policlinico San Matteo, Pavia; Dipartimento Riabilitazione Malattia di Parkinson e Disturbi del Movimento (G. Pinelli, P.O., D.F., G.F.), Ospedale Classificato Moriggia Pelascini di Gravedona; U.S. Riabilitazione Parkinson (L.I., A.M., G.R.), Fondazione Gaetano e Piera Borghi di Brebbia; and UOC Clinica Geriatrica (M.M.), Dipartimento Medico-Geriatrico-Riabilitativo, Università-Azienda Ospedaliero-Universitaria di Parma, Italy.'}]",Neurology,['10.1212/WNL.0000000000007858']
1110,32105310,Association of Biomarker Cutoffs and Endoscopic Outcomes in Crohn's Disease: A Post Hoc Analysis From the CALM Study.,"BACKGROUND


CALM was a randomized phase 3 trial in patients with Crohn's disease (CD) that demonstrated improved endoscopic outcomes when treatment was escalated based on cutoffs for inflammatory biomarkers, fecal calprotectin (FC), C-reactive protein (CRP), and CD Activity Index (CDAI) remission vs CDAI response alone. The purpose of this post hoc analysis of CALM was to identify drivers of treatment escalation and evaluate the association between biomarker cutoff concentrations and endoscopic end points.
METHODS


The proportion of patients achieving CD Endoscopic Index of Severity (CDEIS) <4 and no deep ulcers 48 weeks after randomization was evaluated according to CRP <5 mg/L or ≥5 mg/L and FC <250 μg/g or ≥250 μg/g. Subgroup analyses were performed according to disease location, and sensitivity analyses were conducted in patients with elevated CRP and/or FC at baseline. The association between endoscopic end points and biomarker cutoffs was performed using χ 2 test.
RESULTS


The proportion of patients who achieved the primary end point CDEIS <4 and no deep ulcers was significantly greater for those with FC <250 µg/g (74%; P < 0.001), with an additive effect for CRP <5 mg/L. The association of FC <250 µg/g with improved endoscopic outcomes was independent of disease location, although the greatest association was observed for ileocolonic disease. Fecal calprotectin <250 µg/g, CRP <5 mg/L, and CDAI <150 gave a sensitivity/specificity of 72%/63% and positive/negative predictive values of 86%/42% for CDEIS <4 and no deep ulcers 48 weeks after randomization.
CONCLUSION


This post hoc analysis of CALM demonstrated that a cutoff of FC <250 µg/g is a useful surrogate marker for mucosal healing in CD.",2020,"The association of FC <250 µg/g with improved endoscopic outcomes was independent of disease location, although the greatest association was observed for ileocolonic disease.","['250 μg/g or ≥250 μg', ""Crohn's Disease"", ""patients with Crohn's disease (CD""]","['CDAI', 'FC']","['Fecal calprotectin', 'inflammatory biomarkers, fecal calprotectin (FC), C-reactive protein (CRP), and CD Activity Index (CDAI) remission vs CDAI response alone', 'deep ulcers', 'proportion of patients achieving CD Endoscopic Index of Severity (CDEIS']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0359961,"The association of FC <250 µg/g with improved endoscopic outcomes was independent of disease location, although the greatest association was observed for ileocolonic disease.","[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': 'Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Inflammatory Bowel Disease Unit, Department of Medicine, University of Calgary, AB, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bossuyt', 'Affiliation': 'Imelda General Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Baert', 'Affiliation': 'AZ Delta, Roeselare-Menen, Belgium.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Armuzzi', 'Affiliation': 'Presidio Columbus, Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hébuterne', 'Affiliation': 'Inflammatory Bowel Disease Center, University of Nice-Sophia Antipolis, CHU of Nice, Nice, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Travis', 'Affiliation': 'Translational Gastroenterology Unit, National Institute for Health Research Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Milan, Italy.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'Department of Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Berg', 'Affiliation': 'Global Medical Affairs, AbbVie AB, Solna, Sweden.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Kligys', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Neimark', 'Affiliation': 'Research and Development, Gastroenterology/Immunology, AbbVie Inc., Worcester, MA, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Suleiman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': ""D'Haens"", 'Affiliation': 'Academic Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Colombel', 'Affiliation': 'Department of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Inflammatory bowel diseases,['10.1093/ibd/izaa025']
1111,15672958,Effect of antagonists vs agonists on in vitro fertilization outcome.,"PURPOSE


To compare outcome following in vitro fertilization-embryo transfer (IVF-ET) using controlled ovarian hyperstimulation (COH) regimens using either the gonadotropin-releasing hormone (GnRH) agonist leuprolide acetate vs the GnRH antagonist ganirelix.
METHODS


Women needing IVF for conception were randomly assigned to 300 IU of gonadotropins with ganirelix used in the follicular phase when a follicle with a 14 mm average diameter was attained vs a regimen using leuprolide acetate from the mid-luteal phase of the previous cycle.
RESULTS


There were no differences found in clinical, ongoing, delivered pregnancy rates or implantation rates between groups.
CONCLUSIONS


The use of GnRH antagonists do not seem to reduce IVF outcome compared to using GnRH agonists in COH regimens.",2004,"There were no differences found in clinical, ongoing, delivered pregnancy rates or implantation rates between groups.
",['Women needing IVF for conception'],"['gonadotropins with ganirelix', 'gonadotropin-releasing hormone (GnRH) agonist leuprolide acetate', 'leuprolide acetate', 'vitro fertilization-embryo transfer (IVF-ET']","['IVF outcome', 'pregnancy rates or implantation rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0009637', 'cui_str': 'Conception'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0073629', 'cui_str': 'ganirelix'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0700596', 'cui_str': 'Leuprolide Acetate'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",,0.0332433,"There were no differences found in clinical, ongoing, delivered pregnancy rates or implantation rates between groups.
","[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Check', 'Affiliation': 'The University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School at Camden, Cooper Hospital/University Medical Center, Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology & Infertility, Camden, NJ, USA.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Check', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Choel', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kiefer', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1112,32070754,Effect of smear layer deproteinization with chemo-mechanical caries removal agents on sealing performances of self-etch adhesives.,"OBJECTIVES


To evaluate the sealing performance of self-etch adhesives (SEA) after smear layer deproteinization with chemo-mechanical caries removal agents (CRA) to enamel and dentin cavity walls in comparison with 6% NaOCl smear layer deproteinizing.
METHODS


Eighty extracted bovine incisors with tapered cylindrical cavities (2.5 mm upper diameter, 1.5 mm lower diameter, 2 mm depth) at the cemento-enamel junction were randomly divided into four pre-treatment groups; no treatment (control), Papacarie (papain enzyme-based CRA), Carisolv (NaOCl-based CRA), and 6% NaOCl. After pretreatment, G-Bond Plus (GBP, one-step SEA) or Clearfil SE Bond 2 (CSE, two-step SEA) was applied to the pre-treated cavity, and then filled with a flowable resin composite (Clearfil Majesty ES Flow). Gap formations at the enamel and dentin lateral walls, and on the dentin cavity floor were investigated using swept-source optical coherence tomography (SS-OCT) after 24-h water storage at 37 °C. Deproteinizing effects of the tested agents on smear layer-covered enamel and dentin were quantified by changes in the amide:phosphate ratio using ATR-FTIR analysis.
RESULTS


Papacarie significantly reduced gap formation with both self-etch adhesives at all locations, compared to the control group (p < 0.05). In contrast, increased gap formation was observed with Carisolv and NaOCl. In most groups, CSE exhibited significantly lower gap formation than GBP (p < 0.05). ATR-FTIR revealed a significant decrease in the amide:phosphate ratio for all the deproteinizing agents (p < 0.05).
CONCLUSIONS


Chemo-mechanical CRAs could effectively remove the organic phase of enamel and dentin smear layer. The papain enzyme-based gel Papacarie could improve the sealing performance of the self-etch adhesives to both enamel and dentin.",2020,"RESULTS


Papacarie significantly reduced gap formation with both self-etch adhesives at all locations, compared to the control group (p < 0.05).","['comparison with 6% NaOCl smear layer deproteinizing', 'Eighty extracted bovine incisors with tapered cylindrical cavities (2.5\u2009mm upper diameter, 1.5\u2009mm lower diameter, 2\u2009mm depth) at the cemento-enamel junction']","['no treatment (control), Papacarie (papain enzyme-based CRA), Carisolv (NaOCl-based CRA), and 6% NaOCl', 'self-etch adhesives (SEA', 'G-Bond Plus (GBP, one-step SEA) or Clearfil SE Bond 2 (CSE, two-step SEA', 'CSE']","['sealing performance', 'organic phase of enamel and dentin smear layer', 'amide:phosphate ratio', 'gap formation', 'smear layer-covered enamel and dentin', 'sealing performances of self-etch adhesives']","[{'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0205114', 'cui_str': 'Cylindrical (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0205144', 'cui_str': 'Junctional (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1703313', 'cui_str': 'Papacarie'}, {'cui': 'C0030346', 'cui_str': 'Papain'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0769128', 'cui_str': 'Carisolv'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C1567205', 'cui_str': 'G-Bond'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1098526', 'cui_str': 'Clearfil SE Bond'}]","[{'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0002482', 'cui_str': 'Amides'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}]",80.0,0.0176334,"RESULTS


Papacarie significantly reduced gap formation with both self-etch adhesives at all locations, compared to the control group (p < 0.05).","[{'ForeName': 'Citra', 'Initials': 'C', 'LastName': 'Kusumasari', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan; Department of Conservative Dentistry, Faculty of Dentistry, University of Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdou', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan; Biomaterials Department, Faculty of Dentistry, Modern University for Technology and Information, Cairo, Egypt.'}, {'ForeName': 'Antonin', 'Initials': 'A', 'LastName': 'Tichy', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan; Institute of Dental Medicine, First Faculty of Medicine of the Charles University and General University Hospital in Prague, Czech Republic.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hatayama', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Hosaka', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Foxton', 'Affiliation': ""Division of Conservative Dentistry, King's College London Dental Institute at Guy's King's and St Thomas' Hospitals, King's College London, UK.""}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Advanced Biomaterials, Restoratives Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sumi', 'Affiliation': 'National Center for Geriatrics and Gerodontology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nakajima', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan. Electronic address: nakajima.ope@tmd.ac.jp.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tagami', 'Affiliation': 'Department of Cariology and Operative Dentistry, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103300']
1113,15266759,Neither sildenafil nor vaginal estradiol improves endometrial thickness in women with thin endometria after taking oral estradiol in graduating dosages.,"PURPOSE


To determine if sildenafil improves endometrial thickness better than vaginal estradiol (E2) in women with a history of thin endometria.
METHODS


Women failing to attain an 8 mm endometrial thickness on either the oocyte retrieval cycle or their first frozen embryo transfer (ET) despite an oral graduated E2 regimen were treated again with graduated oral E2 and were also randomly assigned to vaginal sildenafil or vaginal E2 therapy. Endometrial thickness was compared between the groups.
RESULTS


Neither vaginal E2 nor sildenafil significantly improved endometrial thickness or blood flow in the subsequent frozen ET-cycle.
CONCLUSIONS


These data fail to corroborate previous claims that 25 mg sildenafil four times daily intravaginally can improve endometrial thickness.",2004,"Neither vaginal E2 nor sildenafil significantly improved endometrial thickness or blood flow in the subsequent frozen ET-cycle.
","['women with thin endometria after taking oral estradiol in graduating dosages', 'Women failing to attain an 8 mm endometrial thickness on either the oocyte retrieval cycle or their first frozen embryo transfer (ET) despite an oral graduated E2 regimen were treated again with graduated oral E2', 'women with a history of thin endometria']","['vaginal estradiol (E2', 'vaginal sildenafil or vaginal E2 therapy', 'sildenafil']","['endometrial thickness or blood flow', 'endometrial thickness', 'Endometrial thickness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0014180', 'cui_str': 'Endometrium'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0404268', 'cui_str': 'Oocyte Collection'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer (procedure)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",,0.043348,"Neither vaginal E2 nor sildenafil significantly improved endometrial thickness or blood flow in the subsequent frozen ET-cycle.
","[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Check', 'Affiliation': 'The University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School at Camden, Cooper/Hospital University Medical Center, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Graziano', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nazari', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Choe', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dietterich', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1114,15266762,Is assisted hatching beneficial in patients with recurrent implantation failures?,"PURPOSE


To assess the possible role of assisted hatching in patients with recurrent implantation failure during IVF cycles.
DESIGN


Prospective randomized study.
SETTING


IVF unit of an academic medical center.
PATIENTS


Women who underwent IVF after at least three failed IVF-ET attempts.
INTERVENTIONS


Patients were prospectively randomized to undergo assisted hatching of their embryos prior to their replacement by mechanical partial zona dissection.
RESULTS


The study (assisted hatching) and control groups included 104 and 103 patients, respectively. There were no significant between-group differences in patient age, cause of infertility, mean number of previous IVF trials, number of oocytes retrieved, fertilization rate, or number of embryos transferred. No difference in pregnancy rate was noted on comparison of the whole study group, to the whole control group (21% and 27%, respectively). However, when the results were re-analyzed by age groups, assisted hatching was found to be harmful in the youngest group (< 34 years), significantly decreasing pregnancy rates (15% vs 35%, p < 0.05).
CONCLUSION


Repeated implantation failure alone is not an indication for assisted hatching. Although assisted hatching appears to be effective in a selected group of older patients, in younger patients it may further hamper implantation and should be avoided.",2004,"No difference in pregnancy rate was noted on comparison of the whole study group, to the whole control group (21% and 27%, respectively).","['patients with recurrent implantation failures', 'Women who underwent IVF after at least three failed IVF-ET attempts', 'patients with recurrent implantation failure during IVF cycles', 'IVF unit of an academic medical center']",['assisted hatching of their embryos prior to their replacement by mechanical partial zona dissection'],"['pregnancy rates', 'patient age, cause of infertility, mean number of previous IVF trials, number of oocytes retrieved, fertilization rate, or number of embryos transferred', 'pregnancy rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0449951', 'cui_str': 'Number of embryos transferred (qualifier value)'}]",,0.0283171,"No difference in pregnancy rate was noted on comparison of the whole study group, to the whole control group (21% and 27%, respectively).","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Rufas-Sapir', 'Affiliation': 'Infertility & IVF Unit, Department of Obstetrics & Gynecology, Rabin Medical Centre, Beilinson Campus, Petach-Tikva, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Orvieto', 'Affiliation': ''}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Avrech', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kotler', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Pinkas', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bar', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Fisch', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1115,15266763,The importance of diagnostic work-up in the management of candidal vulvovaginitis. A prospective study.,"OBJECTIVE


To assess the accuracy of the diagnostic work-up in identifying vaginal candidal infection, and to determine the safety, efficacy and speed of action of clotrimazole vaginal tablets.
PARTICIPANTS


Two hundred and twenty-three patients with symptoms and signs of candidal infection, a presence of vaginal pH < or = 4.5 and positive 10% KOH examination.
METHODS


After vaginal culture was taken, the eligible patients were treated with clotrimazole 200 mg vaginal tabs (manufactured by Teva or Agis).
RESULTS


Cultures grew Candida albicans in 189 cases (85%), and Candida non-albicans in five (2.2%); 29 patients (13%) did not have any candidal infection. Of the 189 C. albicans-positive patients, 174 were reassessed for effects of clotrimazole treatment by self-reports and objective measures. Ninety-four percent of the patients reported improvement after treatment, rated moderate to high by 87%. The physician evaluation was similar: some improvement in 96%, and moderate or high improvement in 91%. At the second examination, 7.5% of the treated patients still had a positive culture for Candida albicans, and they remained positive on KOH microscopic examination, although vaginal pH was significantly higher. Maximal improvement was recorded three to four days after starting treatment.
CONCLUSION


It is important that the diagnostic work-up for suspected candidal infections consist of at least vaginal pH measurement and microscopy study with KOH. We encourage the use of vaginal cultures, especially in recurrent cases. Clotrimazole is a safe and effective treatment.",2004,"At the second examination, 7.5% of the treated patients still had a positive culture for Candida albicans, and they remained positive on KOH microscopic examination, although vaginal pH was significantly higher.","['Two hundred and twenty-three patients with symptoms and signs of candidal infection, a presence of vaginal pH < or = 4.5 and positive 10% KOH examination']","['clotrimazole 200 mg vaginal tabs (manufactured by Teva or Agis', 'clotrimazole vaginal tablets', 'Clotrimazole', 'clotrimazole']","['vaginal pH', 'KOH microscopic examination', 'positive culture for Candida albicans', 'candidal infection']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0006840', 'cui_str': 'Moniliasis'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH (observable entity)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0985029', 'cui_str': 'Clotrimazole 200 MG'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1245637', 'cui_str': 'Clotrimazole Vaginal Tablet'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}]","[{'cui': 'C0429263', 'cui_str': 'Vaginal pH (observable entity)'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0006837', 'cui_str': 'Candida albicans'}, {'cui': 'C0006840', 'cui_str': 'Moniliasis'}]",223.0,0.0341033,"At the second examination, 7.5% of the treated patients still had a positive culture for Candida albicans, and they remained positive on KOH microscopic examination, although vaginal pH was significantly higher.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ben-Haroush', 'Affiliation': 'Department of Obstetrics and Gynecology, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yogev', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kaplan', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1116,31431411,Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial.,"BACKGROUND


A high-dose, split-virion inactivated trivalent influenza vaccine (IIV3-HD; Fluzone® High-Dose, Sanofi Pasteur) is available for adults ≥65 years of age. This study examined the safety and immunogenicity of a quadrivalent high-dose split-virion inactivated influenza vaccine (IIV4-HD).
METHODS


This was a randomized, modified double-blind, active-controlled, multi-center trial in healthy adults ≥65 years of age. Subjects were randomized in a 4:1:1 ratio to receive a single intramuscular injection of IIV4-HD, the licensed IIV3-HD, or an IIV3-HD containing the alternate B-lineage strain. Hemagglutination inhibition (HAI), seroneutralisation, and anti-neuraminidase antibody titers were measured at baseline and day 28. Solicited reactions were collected for up to 7 days, unsolicited adverse events up to 28 days, and serious adverse events up to 180 days. The primary immunogenicity objective was to demonstrate that IIV4-HD induces HAI geometric mean titers (GMTs) and seroconversion rates that are non-inferior to those induced by IIV3-HD. Secondary objectives were to describe the safety of IIV4-HD and IIV3-HD and to demonstrate that IIV4-HD induces HAI GMTs and seroconversion rates that are superior to those induced by IIV3-HD not containing the same B-lineage strain.
RESULTS


The study included 2670 adults ≥65 years of age. For all four strains, HAI GMTs and seroconversion rates induced by IIV4-HD were non-inferior to those induced by IIV3-HDs containing the same strains. For both B strains, HAI GMTs and seroconversion rates induced by IIV4-HD were superior to those induced by IIV3-HD not containing the same B-lineage strain. Seroneutralisation and anti-neuraminidase antibody responses, measured in a subset of subjects, were similar. No new safety concerns were identified, and the safety profiles of IIV4-HD and IIV3-HD were similar.
CONCLUSIONS


Adding a second B strain in IIV4-HD resulted in improved immunogenicity against the added strain without compromising the immunogenicity of the other strains or the vaccine's tolerability.
CLINICAL TRIAL REGISTRATION


NCT03282240.",2019,"For both B strains, HAI GMTs and seroconversion rates induced by IIV4-HD were superior to those induced by IIV3-HD not containing the same B-lineage strain.","['2670 adults ≥65\u202fyears of age', 'healthy adults ≥65\u202fyears of age', 'adults ≥65\u202fyears of age']","['split-virion inactivated trivalent influenza vaccine (IIV3-HD; Fluzone® High-Dose, Sanofi Pasteur', 'high-dose quadrivalent influenza vaccine', 'quadrivalent high-dose split-virion inactivated influenza vaccine (IIV4-HD', 'single intramuscular injection of IIV4-HD, the licensed IIV3-HD, or an IIV3-HD containing the alternate B-lineage strain']","['Safety and immunogenicity', 'safety of IIV4-HD and IIV3-HD and to demonstrate that IIV4-HD induces HAI GMTs and seroconversion rates', 'serious adverse events', 'Hemagglutination inhibition (HAI), seroneutralisation, and anti-neuraminidase antibody titers', 'IIV4-HD induces HAI geometric mean titers (GMTs) and seroconversion rates', 'unsolicited adverse events', 'safety and immunogenicity', 'safety profiles of IIV4-HD and IIV3-HD', 'HAI GMTs and seroconversion rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0770694'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0027803', 'cui_str': 'N-Acylneuraminate Glycohydrolases'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",2670.0,0.124097,"For both B strains, HAI GMTs and seroconversion rates induced by IIV4-HD were superior to those induced by IIV3-HD not containing the same B-lineage strain.","[{'ForeName': 'Lee-Jah', 'Initials': 'LJ', 'LastName': 'Chang', 'Affiliation': 'Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA. Electronic address: Lee-Jah.Chang@sanofi.com.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Janosczyk', 'Affiliation': 'Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Landolfi', 'Affiliation': 'Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA 18370, USA.'}, {'ForeName': 'H Keipp', 'Initials': 'HK', 'LastName': 'Talbot', 'Affiliation': 'Vanderbilt University Medical Center, 1161 21st Avenue South, Nashville, TN 37232, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.08.016']
1117,31431412,"Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years.","BACKGROUND


Hepatitis B virus (HBV) remains a major public health issue, although it is a vaccine-preventable disease. Adults with diabetes are at greater risk of contracting HBV than the general population. Commonly used 3-dose HBV vaccines have reduced immunogenicity in older individuals and in those with diabetes mellitus.
METHODS


In this post hoc analysis of a phase 3 clinical trial, participants with type 2 diabetes mellitus aged 60-70 years received either 2-dose HBsAg/CpG 1018 (HEPLISAV-B®, n = 327) at 0 and 4 weeks and placebo at 24 weeks or 3-dose HBsAg/alum (Engerix-B®, n = 153) at 0, 4, and 24 weeks. Immunogenicity, including seroprotection rate (SPR) at week 28, and safety were assessed by subgroup (sex, body mass index, and smoking status). SPR was defined as antibody against hepatitis B surface antigen serum concentration ≥10 mIU/mL.
RESULTS


The SPR at week 28 was significantly higher with HBsAg/CpG 1018 (85.8% [235/274]) than with HBsAg/alum (58.5% [76/130]) in the per-protocol analysis, for an overall difference of 27.3% (95% CI, 18.0-36.8). SPRs with HBsAg/CpG 1018 were consistently markedly higher compared with HBsAg/alum, regardless of sex, body mass index, or smoking status. Adverse events and deaths were comparable between groups.
CONCLUSIONS


Two-dose HBsAg/CpG 1018 provides a higher level of seroprotection against HBV than does a 3-dose vaccine (HBsAg/alum) with a similar safety profile in patients aged 60-70 years with type 2 diabetes mellitus. Study identifier: NCT02117934.",2019,"SPRs with HBsAg/CpG 1018 were consistently markedly higher compared with HBsAg/alum, regardless of sex, body mass index, or smoking status.","['participants with type 2 diabetes mellitus aged 60-70\u202fyears received either', 'persons with diabetes mellitus aged 60-70\u202fyears', 'patients aged 60-70\u202fyears with type 2 diabetes mellitus', 'Adults with diabetes']","['2-dose hepatitis B vaccine, HBsAg/CpG', '2-dose HBsAg/CpG 1018 (HEPLISAV-B®, n\u202f=\u202f327) at 0 and 4\u202fweeks and placebo', 'HBV vaccines']","['SPR', 'Immunogenicity and safety', 'Immunogenicity, including seroprotection rate (SPR', 'level of seroprotection against HBV', 'Adverse events and deaths']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C4541385', 'cui_str': 'Heplisav-B'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1018.0,0.154594,"SPRs with HBsAg/CpG 1018 were consistently markedly higher compared with HBsAg/alum, regardless of sex, body mass index, or smoking status.","[{'ForeName': 'Randall N', 'Initials': 'RN', 'LastName': 'Hyer', 'Affiliation': 'Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710, United States. Electronic address: rhyer@dynavax.com.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Janssen', 'Affiliation': 'Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, CA 94710, United States. Electronic address: rjanssen@dynavax.com.'}]",Vaccine,['10.1016/j.vaccine.2019.08.005']
1118,31443993,"The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial.","BACKGROUND


This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap) when co-administered in adults aged ≥50 years.
METHODS


In this open label, multi-center study (NCT02052596), participants were randomized 1:1 to the Co-Administration group (RZV dose 1 and Tdap at Day 0 [D0], RZV dose 2 at Month 2 [M2]) or Control group (Tdap at D0, RZV dose 1 at M2, RZV dose 2 at M4). Co-primary objectives were evaluation of the vaccine response rate (VRR) to RZV in the Co-Administration group, and demonstration of non-inferiority of the humoral responses to RZV and Tdap in the Co-Administration compared to Control group. Reactogenicity and safety of RZV and Tdap were also assessed.
RESULTS


VRR to RZV was 97.8% in the Co-Administration group. The non-inferiority criterion was met for the humoral response to RZV and for 4 Tdap antigens, but was not met for the Tdap antigen pertactin. Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups.
CONCLUSIONS


Co-administration of RZV and Tdap did not interfere with the humoral immune response to RZV or 4 of the 5 Tdap antigens. No safety concerns were identified.",2019,"Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups.
","['adults aged ≥50\u202fyears', 'adults', 'aged ≥50 years']","['adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap', 'Co-Administration group (RZV dose 1 and Tdap at Day 0', 'recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine']","['Reactogenicity and safety of RZV and Tdap', 'humoral immune response', 'vaccine response rate (VRR', 'Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0535644', 'cui_str': 'DTaP Vaccines'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0031237', 'cui_str': 'Pertussis Vaccine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1155229'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0603903,"Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups.
","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Strezova', 'Affiliation': 'GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: ana.x.strezova@gsk.com.'}, {'ForeName': 'Himal', 'Initials': 'H', 'LastName': 'Lal', 'Affiliation': 'GSK, 2301 Renaissance Blvd, King of Prussia, PA 19406-2772, USA. Electronic address: himallal@pfizer.com.'}, {'ForeName': 'Igwebuike', 'Initials': 'I', 'LastName': 'Enweonye', 'Affiliation': 'GSK, 81-87 Hullenberweg, Amsterdam 1101 CL, Netherlands. Electronic address: igwebuike.x.enweonye@gsk.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Campora', 'Affiliation': 'GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: laura.e.campora@gsk.com.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Beukelaers', 'Affiliation': 'GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: pierre.x.beukelaers@gsk.com.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Segall', 'Affiliation': 'Clinical Research Atlanta, 175 Country Club Dr. Ste A, Stockbridge 30281, GA, USA. Electronic address: nsegall@clinicalresearchatlanta.com.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Heineman', 'Affiliation': 'GSK, 2301 Renaissance Blvd, King of Prussia, PA 19406-2772, USA. Electronic address: tch3768@gmail.com.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Schuind', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA. Electronic address: Anne.E.Schuind@gsk.com.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, 20 Avenue Fleming, 1300 Wavre, Belgium. Electronic address: cornelia.oostvogels@orange.fr.'}]",Vaccine,['10.1016/j.vaccine.2019.08.001']
1119,30379634,Does Virtual Reality Increase Simulator Sickness During Exposure Therapy for Post-Traumatic Stress Disorder?,"Purpose:  Measurement of simulator-related side effects (SSEs) is an integral component of competent and ethical use of virtual reality exposure (VRE), but common SSEs may overlap with symptoms of anxiety. Limited research exists about the frequency of SSEs during VRE treatment for post-traumatic stress disorder (PTSD) and no research compares self-reported SSEs for those undergoing VRE with those participating in exposure therapy without virtual reality. This study compared the SSEs of active duty soldiers with PTSD randomly assigned to exposure therapy through traditional prolonged exposure or VRE.   Methodology:  A total of 108 soldiers participated in up to 10 sessions of exposure therapy. Of those, 93 provided data on simulator sickness both before and after initiation of imaginal exposure. Approximately half ( n  = 49) used the Virtual Iraq/Afghanistan system to support engagement with their trauma memory. Soldiers completed a 4-item, self-reported measure of SSE after each session.   Results:  Controlling for age, gender, baseline anxiety symptoms, and SSE symptom counts at the first two sessions of therapy (before initiating imaginal exposure), there was no statistically significant difference between the treatment groups in SSEs at the beginning of imaginal exposure or over the course of treatment.   Conclusions:  This finding suggests that caution should be exercised in the interpretation of SSE measurements during the use of VRE for PTSD. Virtual reality did not account for any increase in self-reported SSE. It is possible that anxiety accounts for a meaningful proportion of SSE reports during VRE.",2019,Virtual reality did not account for any increase in self-reported SSE.,['A total of 108 soldiers participated in up to 10 sessions of exposure therapy'],['Virtual Reality Increase Simulator Sickness'],"['baseline anxiety symptoms, and SSE symptom counts']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",108.0,0.0386006,Virtual reality did not account for any increase in self-reported SSE.,"[{'ForeName': 'Greg M', 'Initials': 'GM', 'LastName': 'Reger', 'Affiliation': 'Mental Health Service, VA Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Smolenski', 'Affiliation': 'Psychological Health Center of Excellence, Defense Health Agency, Joint Base Lewis-McChord, Tacoma, Washington.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Edwards-Stewart', 'Affiliation': 'Psychological Health Center of Excellence, Defense Health Agency, Joint Base Lewis-McChord, Tacoma, Washington.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Skopp', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Albert Skip', 'Initials': 'AS', 'LastName': 'Rizzo', 'Affiliation': 'Institute for Creative Technologies, University of Southern California, Playa Vista, California.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Norr', 'Affiliation': 'Mental Health Service, VA Puget Sound Health Care System, Seattle, Washington.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0175']
1120,32103280,Event-related and readiness potentials when preparing to approach and avoid alcohol cues following cue avoidance training in heavy drinkers.,"RATIONALE


Cue avoidance training (CAT) reduces alcohol consumption in the laboratory. However, the neural mechanisms that underlie the effects of this intervention are poorly understood.
OBJECTIVES


The present study investigated the effects of a single session of CAT on event-related and readiness potentials during preparation of approach and avoidance movements to alcohol cues.
METHODS


Heavy drinking young adults (N = 60) were randomly assigned to complete either CAT or control training. After training, we recorded participants' event-related and motor readiness potentials as they were preparing to respond.
RESULTS


In the CAT group, N200 amplitude was higher when preparing to approach rather than avoid alcohol pictures. In the control group, N200 amplitudes did not differ for approach and avoidance to alcohol pictures. Regarding the late positive potential (LPP), in the CAT group, the negativity of this was blunted when preparing to avoid alcohol pictures relative to when preparing to avoid control pictures. In the control group, the negativity of the LPP was blunted when preparing to approach alcohol pictures relative to when preparing to approach control pictures. There were no effects on motor readiness potentials. Behavioural effects indicated short-lived effects of training on reaction times during the training block that did not persist when participants were given time to prepare their motor response before executing it during the EEG testing block.
CONCLUSIONS


After a single session of CAT, the enhanced N200 when approaching alcohol cues may indicate the engagement of executive control to overcome the associations learned during training. These findings clarify the neural mechanisms that may underlie the effects of CAT on drinking behaviour.",2020,"In the control group, N200 amplitudes did not differ for approach and avoidance to alcohol pictures.","['Heavy drinking young adults (N\u2009=\u200960', 'heavy drinkers']","['Cue avoidance training (CAT', 'cue avoidance training', 'CAT or control training', 'CAT']","['alcohol consumption', 'negativity of the LPP', 'reaction times', 'motor readiness potentials']","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C1704305', 'cui_str': 'Readiness Potential'}]",60.0,0.029772,"In the control group, N200 amplitudes did not differ for approach and avoidance to alcohol pictures.","[{'ForeName': 'Lisa C G', 'Initials': 'LCG', 'LastName': 'Di Lemma', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, Liverpool, UK. l.dilemma@chester.ac.uk.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Stancak', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Soto', 'Affiliation': 'Centre for Social and Cognitive Neuroscience, School of Psychology, Universidad Adolfo Ibáñez, Las Condes, Santiago, Chile.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Fallon', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Field', 'Affiliation': 'UK Centre for Tobacco and Alcohol Studies, Liverpool, UK.'}]",Psychopharmacology,['10.1007/s00213-020-05462-7']
1121,31473913,Intercostal block vs. epidural analgesia in thoracoscopic lung cancer surgery: a randomized trial.,"OBJECTIVES


To explore the best strategy for combatting pain after thoracoscopic lobectomy for cancer.
METHODS


We conducted a randomized-controlled trial to compare two major analgesic procedures-intercostal nerve block and epidural analgesia-in patients scheduled to undergo thoracoscopic lobectomy and lymphadenectomy. High-dose oral celecoxib was started 3 h after operation in intercostal nerve block group or after withdrawal of epidural analgesia in epidural analgesia group. The primary endpoint was postoperative pain and adverse events, and the secondary endpoint was the length of the analgesic procedure and physiological function on postoperative day 1.
RESULTS


This study was closed before accumulating the necessary sample size. We eventually analyzed 21 patients undergoing intercostal nerve block and 22 patients undergoing epidural analgesia. Although the incidence of postoperative adverse events and postoperative complications was comparable between the groups, the incidence of procedure-related troubles was significantly higher in the epidural analgesia group than in the intercostal nerve block group. The length of the analgesic procedure was significantly shorter in the intercostal nerve block group than in the epidural analgesic group. The postoperative pain during postoperative days 0-7, as evaluated by a visual analog scale, was not significantly different between the groups. Likewise, postoperative physiological function, as evaluated by vital capacity and walking distance, was not significantly different between the groups.
CONCLUSION


Although our limited sample size compromised our ability to draw definitive conclusions, intercostal nerve block followed by high-dose oral celecoxib seems to be an option for patients undergoing thoracoscopic lobectomy for lung cancer.",2020,The length of the analgesic procedure was significantly shorter in the intercostal nerve block group than in the epidural analgesic group.,"['combatting pain after thoracoscopic lobectomy for cancer', 'patients undergoing thoracoscopic lobectomy for lung cancer', 'patients scheduled to undergo', '21 patients undergoing intercostal nerve block and 22 patients undergoing', 'thoracoscopic lung cancer surgery']","['epidural analgesia', 'celecoxib', 'major analgesic procedures-intercostal nerve block and epidural analgesia', 'thoracoscopic lobectomy and lymphadenectomy', 'Intercostal block vs. epidural analgesia']","['length of the analgesic procedure', 'vital capacity and walking distance', 'postoperative pain', 'visual analog scale', 'incidence of procedure-related troubles', 'Likewise, postoperative physiological function', 'postoperative pain and adverse events', 'length of the analgesic procedure and physiological function on postoperative day 1', 'postoperative adverse events and postoperative complications']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block (procedure)'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",,0.112088,The length of the analgesic procedure was significantly shorter in the intercostal nerve block group than in the epidural analgesic group.,"[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'Department of Surgery and Clinical Science, Division of Chest Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, 755-8505, Yamaguchi, Japan. uedakazu@m.kufm.kagoshima-u.ac.jp.'}, {'ForeName': 'Masataro', 'Initials': 'M', 'LastName': 'Hayashi', 'Affiliation': 'Department of Surgery and Clinical Science, Division of Chest Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, 755-8505, Yamaguchi, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Murakami', 'Affiliation': 'Department of Surgery and Clinical Science, Division of Chest Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, 755-8505, Yamaguchi, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Surgery and Clinical Science, Division of Chest Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, 755-8505, Yamaguchi, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Utada', 'Affiliation': 'Department of Anesthesiology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, 755-8505, Yamaguchi, Japan.'}, {'ForeName': 'Kimikazu', 'Initials': 'K', 'LastName': 'Hamano', 'Affiliation': 'Department of Surgery and Clinical Science, Division of Chest Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1 Minami-Kogushi, Ube, 755-8505, Yamaguchi, Japan.'}]",General thoracic and cardiovascular surgery,['10.1007/s11748-019-01197-1']
1122,12635747,A comparative study of the effect of ovarian stimulation protocols with different gonadotropin preparations on the biological and clinical parameters of the outcome of intracytoplasmic sperm injection.,"Intracytoplasmic sperm injection (ICSI) is widely employed today in cases of severe male factor infertility. This technique requires denuding the oocytes from the surrounding granulosa cells prior to sperm injection. One can thus assess oocyte maturity more accurately and can study the effects of various ovarian stimulation protocols on egg maturation and the rest of the parameters of the outcome of ICSI. The aim of the present study was to compare the outcome of ovarian stimulation using human menopausal gonadotropin (hMG) with that achieved by using highly purified follicle stimulating hormone (pFSH). The biological and clinical parameters of the outcome of ICSI in 99 subfertile couples were studied. Group A consisted of 46 patients to whom hMG was administered and Group B consisted of 53 patients to whom pFSH was employed for ovarian stimulation. The fertilization rate was significantly higher in the pFSH group but all other factors were similar, including the percentage of mature oocytes and pregnancy rate. The latter does not seem to be affected by the gonadotropin preparation employed for ovarian stimulation. This is very helpful for the physician to know since a gonadotropin with a lower cost can be employed and, in addition, shortage of some preparations of gonadotropins occurs frequently.",2002,"The fertilization rate was significantly higher in the pFSH group but all other factors were similar, including the percentage of mature oocytes and pregnancy rate.",['99 subfertile couples'],"['hMG', 'Intracytoplasmic sperm injection (ICSI', 'pFSH', 'ovarian stimulation using human menopausal gonadotropin (hMG', 'highly purified follicle stimulating hormone (pFSH', 'gonadotropin preparations']","['percentage of mature oocytes and pregnancy rate', 'fertilization rate']","[{'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}]","[{'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}]",99.0,0.023864,"The fertilization rate was significantly higher in the pFSH group but all other factors were similar, including the percentage of mature oocytes and pregnancy rate.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Drakakis', 'Affiliation': 'IVF Unit, Alexandra Maternity Hospital, 1st Dept. of OB/GYN, Athens University Medical School, Athens, Greece.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Loutradis', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kallianidis', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bletsa', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Milingos', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dionyssiou-Asteriou', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Michalas', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1123,12635742,Thromboprophylaxis throughout pregnancy in women with previous history of recurrent miscarriages of unknown aetiology.,"The purpose of this prospective preliminary clinical study was to assess the efficacy of thromboprophylaxis throughout pregnancy in women with a history of unexplained first trimester recurrent miscarriages. From the 53 patients originally assigned to the study 15 were excluded. The remaining 38 were treated with low molecular weight heparin (LMWH-natroparine calcium 0.3 ml twice daily) and low dose aspirin from the day the fetal heart motion was detected until the 37th week or earlier at the onset of premature labor. Among the patients treated (n = 38) thrombophilia screening was positive in 16 patients and in the remaining 22 no causative factor was detected. The overall success rate (viable pregnancy > or = 24 weeks) was 92.2% with no significant difference between patients with positive or negative thrombophilia screening. The most significant complications were: preeclampsia (21%), IUGR (26%), placenta abruptio (5.2%), injection site haematoma (44%) and skin reaction (15.7%). No abnormal bleeding was observed during vaginal or caesarean section. The results of this study suggest that thromboprophylaxis during pregnancy, which has already been successfully tried in patients with recurrent miscarriages with a causative factor, may be similarly effective in patients with such a pregnancy complication but of unknown aetiology.",2002,The overall success rate (viable pregnancy > or = 24 weeks) was 92.2% with no significant difference between patients with positive or negative thrombophilia screening.,"['women with previous history of recurrent miscarriages of unknown aetiology', 'patients with recurrent miscarriages with a causative factor', '53 patients originally assigned to the study 15 were excluded', 'women with a history of unexplained first trimester recurrent miscarriages']","['low molecular weight heparin (LMWH-natroparine calcium 0.3 ml twice daily) and low dose aspirin', 'Thromboprophylaxis', 'thromboprophylaxis']","['overall success rate', 'placenta abruptio', 'injection site haematoma', 'preeclampsia', 'thrombophilia screening', 'skin reaction', 'abnormal bleeding', 'IUGR']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0000809', 'cui_str': 'Recurrent Early Pregnancy Loss'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C1314792', 'cui_str': 'Causality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0032979', 'cui_str': 'Early Placental Phase'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C0542008', 'cui_str': 'Injection site haematoma'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0398623', 'cui_str': 'Hypercoagulability'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}]",53.0,0.0372887,The overall success rate (viable pregnancy > or = 24 weeks) was 92.2% with no significant difference between patients with positive or negative thrombophilia screening.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tzafettas', 'Affiliation': '3rd University Department of Obstetrics and Gynaecology, Hippokrateio Hospital of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mamopoulos', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Anapliotis', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Loufopoulos', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Psarra', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Klearchou', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mamopoulos', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1124,12519036,"Clinical trial comparing the activity and efficacy of ibuprofen isobutanolammonium vs Benzydamine hydrochloride, applied as vaginal irrigations, in patients with vaginitis.","This study was conducted on 30 female patients (average age: 40.5 +/- 11 years, age range 19-65), affected by vulval and/or vaginal phlogosis with a prevalence of uterine fibromyomatosis and metrorrhagia of a varied nature. Sixteen patients were affected with vulvitis and 14 with vulvovaginitis. Fifteen patients were assigned to the treatment with Ibuprofen isobutanolammonium and 15 to the treatment with Benzydamine hydrochloride. Both the subjective symptoms (burning and itching) and the objective symptoms (erythema, oedema, exudation) showed a marked reduction as early as the third day of treatment and the comparison between the score at the start of treatment and on day three of the treatment was highly significant in both study groups (p < 0.01). This improvement was, however, more marked in the group of patients treated with ibuprofen isobutanolammonium, where a more rapid reduction of both the subjective and objective symptoms was observed on the third day. This trend, although not as marked as on the third day, was confirmed at the end of the study, on the seventh day.",2002,"Both the subjective symptoms (burning and itching) and the objective symptoms (erythema, oedema, exudation) showed a marked reduction as early as the third day of treatment and the comparison between the score at the start of treatment and on day three of the treatment was highly significant in both study groups (p < 0.01).","['11 years, age range 19-65), affected by vulval and/or vaginal phlogosis with a prevalence of uterine fibromyomatosis and metrorrhagia of a varied nature', 'Sixteen patients were affected with vulvitis and 14 with vulvovaginitis', 'patients with vaginitis', 'Fifteen patients', '30 female patients (average age: 40.5 ']","['ibuprofen isobutanolammonium vs Benzydamine hydrochloride', 'Ibuprofen isobutanolammonium', 'Benzydamine hydrochloride']","['subjective and objective symptoms', 'subjective symptoms (burning and itching', 'objective symptoms (erythema, oedema, exudation']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0025874', 'cui_str': 'Dysfunctional Uterine Bleeding'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042996', 'cui_str': 'Vulvitis'}, {'cui': 'C0042998', 'cui_str': 'Vulvovaginitis'}, {'cui': 'C0042267', 'cui_str': 'Vaginitis'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0282070', 'cui_str': 'Benzydamine Hydrochloride'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0311437', 'cui_str': 'Exudation, function (observable entity)'}]",30.0,0.0151142,"Both the subjective symptoms (burning and itching) and the objective symptoms (erythema, oedema, exudation) showed a marked reduction as early as the third day of treatment and the comparison between the score at the start of treatment and on day three of the treatment was highly significant in both study groups (p < 0.01).","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pullè', 'Affiliation': 'Department of Gynecology Obstetrics and Reproductive Medicine, University of Messina, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sturlese', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1125,12519049,The effects of add-back therapy with tibolone on myoma uteri.,"In this prospective, randomized, double-blind study, we evaluated the effects of tibolone therapy in association with preoperative gonadotropin releasing hormone agonist (GnRHa) therapy on the reduction of myoma volume. Twenty patients with myoma uteri were divided into two groups. Group I was given monthly triptoreline (3.75 mg every 28 days IM) treatment for six months. As for group II, tibolone was added on to this treatment. For all of the patients, physical examinations, pelvic ultrasonography, and hormone analyses were carried out and the myoma volume was measured by ultrasonography. The patients were called every month and physical examination, ultrasonography and hormone analyses were repeated. Side-effects were recorded. The SPSS/PC 6.0 program was used for statistical analysis. Statistical significance was defined as a p < 0.05. The results are expressed as means +/- SD. While the average volume of myoma was 72.97 +/- 68.5 cm3 in group I, 78.83 +/- 74.1 cm3 in group II before treatment; it was reduced to 29.91 +/- 27.8 cm3 in group I at the end of six months of treatment. Reductions of 59.6% in group I and 63.9% in group II were determined, however the difference was not statistically significant (p > 0.05). At the beginning the level of serum estradiol was 65.4 +/- 22.3 pg/ml in group I which decreased to 37.2 +/- 4.2 pg/ml by the end of the first month. Amenorrhea occurred in six patients after the second injection and four patients after the third injection in group I. Whereas the level of estradiol was 60.9 +/- 19.5 pg/ml in group II at the beginning, it was reduced to 40.5 +/- 6.2 pg/ml by the end of the first month. Amenorrhea occurred in four patients after the second injection and four patients after the third injection in group II. In group I the patients had the problem of flushing (80%), vaginal dryness (50%), and night sweats (30%). In group II these rates were 30%, 20%, and 20%, respectively. Triptoreline is a GnRHa which has been found to be effective in reducing myoma volume, but this effect could not be deactivated with tibolone. However, a decrease was observed in the side-effects resulting from hypoestrogenism.",2002,"Reductions of 59.6% in group I and 63.9% in group II were determined, however the difference was not statistically significant (p > 0.05).","['myoma uteri', 'Twenty patients with myoma uteri']","['gonadotropin releasing hormone agonist (GnRHa) therapy', 'Triptoreline', 'tibolone', 'triptoreline', 'tibolone therapy']","['problem of flushing', 'level of serum estradiol', 'Amenorrhea', 'level of estradiol', 'reduction of myoma volume', 'average volume of myoma', 'vaginal dryness']","[{'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0076660', 'cui_str': 'tibolone'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness (disorder)'}]",20.0,0.015754,"Reductions of 59.6% in group I and 63.9% in group II were determined, however the difference was not statistically significant (p > 0.05).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Göçmen', 'Affiliation': ""'Department of Obstetrics and Gynecology, Gaziantep University, School of Medicine, Gaziantep, Turkey.""}, {'ForeName': 'I Hamdi', 'Initials': 'IH', 'LastName': 'Kara', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Karaca', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1126,12519045,The effect of delivery on umbilical arterial cord blood gases and lipid peroxides: comparison of vaginal delivery and cesarean section.,"Umbilical arterial blood gas analysis is the most objective method to assess fetal well being at birth, is the gold standard assessment of uteroplacental function and fetal oxygenation/acid-base status at birth, and it excludes the diagnosis of birth asphyxia in approximately 80% of depressed newborns at term. This study was designed to determine the effect of the type of delivery on umbilical cord blood gases and on free radical activity together with antioxidation in the fetus. Ninety-six pregnant women between 37 and 42 weeks of gestation were included to the study and randomly assigned to the one of three groups: Group 1 (n = 40) were vaginally delivered, Group 2 (n = 26) had cesarean section with epidural anaesthesia, and Group 3 (n = 30) had cesarean section under general anaesthesia. Umbilical artery blood gas analysis was performed just after the delivery of the fetus together with melondealdehyde and glutathione. The umbilical arterial PO2 was found to be higher in Group 3, and malondealdehyde and glutathione levels were lower in newborns of Group 2. It can be concluded that cesarean section with epidural anaesthesia is safer when lipid peroxides are concerned.",2002,"The umbilical arterial PO2 was found to be higher in Group 3, and malondealdehyde and glutathione levels were lower in newborns of Group 2.","['vaginal delivery and cesarean section', 'Ninety-six pregnant women between 37 and 42 weeks of gestation']","['umbilical arterial cord blood gases and lipid peroxides', 'cesarean section with epidural anaesthesia', 'cesarean section under general anaesthesia']","['umbilical arterial PO2', 'Umbilical artery blood gas analysis', 'umbilical cord blood gases', 'malondealdehyde and glutathione levels']","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0023776', 'cui_str': 'Lipid Hydroperoxide'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C1283004', 'cui_str': 'PO>2< measurement (procedure)'}, {'cui': 'C0041632', 'cui_str': 'Umbilical Arteries'}, {'cui': 'C0005800', 'cui_str': 'Blood Gas Analysis'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",96.0,0.038795,"The umbilical arterial PO2 was found to be higher in Group 3, and malondealdehyde and glutathione levels were lower in newborns of Group 2.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pence', 'Affiliation': 'Department of Physiology, University of Gaziantep, Faculty of Medicine, Gaziantep, Turkey.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kocoglu', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Balat', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Balat', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1127,31437476,The effects of mindfulness training on competition-induced anxiety and salivary stress markers in elite Wushu athletes: A pilot study.,"OBJECTIVE


Due to the impact of stress and related psychophysiological responses on competitive performance, psychological interventions that reduce stress and may thus increase athletic performance need to be evaluated. In this pilot study, the effects of a mindfulness-based intervention (MBI) on competitive anxiety, self-confidence and mindfulness, and autonomic and endocrine stress responses to a competition in elite athletes were explored.
METHODS


Twenty-six male elite Wushu athletes (N = 26) were randomly assigned to either MBI (8 weeks) or a wait-list control group. Both groups participated in three competitions at baseline, immediately post intervention, and at a 2-month follow-up. Athletes completed the Competitive State Anxiety Inventory-2 prior to the competitions. Saliva, from which the stress markers cortisol (sCort) and alpha-amylase (sAA) were determined, was collected prior to and after competitions as well as after awakening and in the evening of competition days.
RESULTS


Repeated measures ANOVAs showed that the MBI group, but not the wait-list control group, demonstrated an increase in self-confidence and mindfulness and a decrease in competitive anxiety from baseline to post intervention (all p < .001, all ɳ p 2  > 0.39). The MBI group exhibited lower sCort daily levels (p = .001, ɳ p 2  = 0.332) and lower sCort (p = .013, ɳ p 2  = 0.121) and sAA responses (p = .022, ɳ p 2  = 0.119) to the competition after the intervention. Daily sAA was unaffected by the intervention (p = .742, ɳ p 2  = 0.011). These changes remained stable up to the 2-month follow-up.
CONCLUSIONS


The present pilot study suggested that mindfulness-based intervention might be associated with a diminished physiological and psychological stress responses to competition. Whether this in turn translates to change in performance needs to be examined in future studies with larger samples. Moreover, different sport activities need to be considered before findings can be generalized.",2019,"Daily sAA was unaffected by the intervention (p = .742, ɳ p 2  = 0.011).","['elite Wushu athletes', 'Twenty-six male elite Wushu athletes (N\u202f=\u202f26', 'elite athletes']","['mindfulness-based intervention (MBI', 'mindfulness training', 'MBI (8\u202fweeks) or a wait-list control group']","['sCort daily levels', 'stress markers cortisol (sCort) and alpha-amylase (sAA', 'competitive anxiety, self-confidence and mindfulness, and autonomic and endocrine stress responses', 'Daily sAA', 'sAA responses', 'self-confidence and mindfulness', 'competitive anxiety', 'competition-induced anxiety and salivary stress markers']","[{'cui': 'C4045998', 'cui_str': 'Wushu'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C3853624', 'cui_str': 'alpha-amylase'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}]",26.0,0.0183272,"Daily sAA was unaffected by the intervention (p = .742, ɳ p 2  = 0.011).","[{'ForeName': 'Amir Hossien', 'Initials': 'AH', 'LastName': 'Mehrsafar', 'Affiliation': 'Department of Sport Psychology, Faculty of Sports Sciences, University of Tehran, Tehran, Iran. Electronic address: a.mehrsafar@ut.ac.ir.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Strahler', 'Affiliation': 'Department of Psychotherapy and Systems Neuroscience, Faculty of Psychology and Sport Science, University of Giessen, Giessen, Germany. Electronic address: jana.strahler@psychol.uni-giessen.de.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Department of Health Science and Technology, School of Medicine and Health, Aalborg University, Aalborg, Denmark. Electronic address: gazerani@hst.aau.dk.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Khabiri', 'Affiliation': 'Department of Sport Psychology, Faculty of Sports Sciences, University of Tehran, Tehran, Iran. Electronic address: mkhabiri@ut.ac.ir.'}, {'ForeName': 'José Carlos Jaenes', 'Initials': 'JCJ', 'LastName': 'Sánchez', 'Affiliation': 'Department of Social Anthropology, Basic Psychology and Health, Universidad Pablo de Olavide, Seville, Spain. Electronic address: jcjaesan@upo.es.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Moosakhani', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sports Sciences, University of Tehran, Tehran, Iran. Electronic address: ar.moosakhani@ut.ac.ir.'}, {'ForeName': 'Ali Moghadam', 'Initials': 'AM', 'LastName': 'Zadeh', 'Affiliation': 'Department of Psychology, Faculty of Psychology and Education, University of Tehran, Tehran, Iran. Electronic address: amoghadamzadeh@ut.ac.ir.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112655']
1128,31888707,The efficacy of iCBT added to treatment as usual for alcohol-dependent patients in primary care: study protocol for a randomized controlled trial.,"BACKGROUND


Alcohol dependence is a common disorder with a continuum regarding severity. Most alcohol-dependent persons have a moderate level of dependence and live under socially orderly conditions. Treatment-seeking in this group is low, mainly due to stigma and because treatment options are seen as unappealing. Alcohol is a relevant topic to discuss in many primary care (PC) consultations and PC is less stigmatizing to visit compared to addiction care units for people with alcohol problems. However, general practitioners (GPs) hesitate to engage in treating alcohol problems due to time constraints and lack of knowledge. Screening and brief interventions are effective for high consumers but there are few studies on dependence.
METHODS


This is a two-group, parallel, randomized controlled trial (RCT). The aim is to study whether an Internet-based Cognitive Behavioral Treatment (iCBT) when added to treatment as usual (TAU) is more effective than TAU only for alcohol dependence in PC. Two hundred and sixty adults with alcohol dependence will be included. Participants are randomized to iCBT and TAU or TAU only. The primary study outcome is alcohol consumption in grams per week and heavy-drinking days. Secondary outcomes include alcohol-related problem severity, number of diagnostic criteria for alcohol dependence, depression and anxiety symptoms, health-related quality of life and biochemical markers for high consumption and liver pathology. Data will be analyzed using mixed-effect models.
DISCUSSION


Internet-based interventions are attractive to, and have been shown to reach, people with alcohol problems. Yet there are no studies investigating the efficacy of Internet treatment of alcohol dependence in PC. In this study we hypothesize that iCBT when added to TAU will improve treatment outcome for alcohol dependence in PC, compared to TAU only. If effective, iCBT can be distributed to the public to a low cost for a stakeholder and has the opportunity to reduce both short-term and long-term public health costs.
TRIAL REGISTRATION


ISRCTN69957414. Retrospectively registered on 7 June 2018.",2019,"If effective, iCBT can be distributed to the public to a low cost for a stakeholder and has the opportunity to reduce both short-term and long-term public health costs.
","['people with alcohol problems', 'Two hundred and sixty adults with alcohol dependence']","['iCBT', 'Internet-based Cognitive Behavioral Treatment (iCBT', 'TAU']","['alcohol-related problem severity, number of diagnostic criteria for alcohol dependence, depression and anxiety symptoms, health-related quality of life and biochemical markers for high consumption and liver pathology', 'alcohol consumption in grams per week and heavy-drinking days']","[{'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034380'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",260.0,0.0865311,"If effective, iCBT can be distributed to the public to a low cost for a stakeholder and has the opportunity to reduce both short-term and long-term public health costs.
","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hyland', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, 17177, Stockholm, Sweden. karin.hyland@ki.se.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hammarberg', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, 17177, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, 17177, Stockholm, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Centre for Dependency Disorders, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Andreasson', 'Affiliation': 'Centre for Dependency Disorders, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}]",Trials,['10.1186/s13063-019-3902-6']
1129,12092689,Progress in the treatment of childhood diabetes mellitus and obesity.,"The 61st Annual Meeting and Scientific Sessions of the American Diabetes Association (ADA) in Philadelphia, PA, (June 22-26, 2001) presented many topics of interest to pediatric clinicians. Of particular interest were the results of the insulin injection arm of the Diabetes Prevention Trial for type 1 diabetes mellitus (DM) (DPT-1). Over 80,000 relatives of patients with type 1 DM were screened. Ultimately, 339 subjects were randomized either to active therapy (twice daily insulin injections plus an annual insulin infusion) or to close observation. Risk prediction algorithms appeared to be accurate. Unfortunately, however, insulin therapy did not decrease the risk of developing DM. Of note, this was primarily a pediatric study with most of those randomized under 21 years of age. As expected, young subjects (<12 years) progressed toward the development of DM at a faster rate than older subjects (>15 years). The second arm of the DPT-1 trial, testing oral insulin in those with intermediate risk (25-50%) for DM, is still recruiting subjects. The controversial topic of continuous subcutaneous insulin infusion (CSII) in young children was also addressed. Many investigators presented data strongly supporting the successful use of infusion pumps in young children. In general, glycemic control was improved or remained stable, the incidence of severe hypoglycemia was low, and families reported more flexibility in their lifestyle. Obesity, an increasing problem in pediatric patients, was also addressed.",2002,"In general, glycemic control was improved or remained stable, the incidence of severe hypoglycemia was low, and families reported more flexibility in their lifestyle.","['young children', '339 subjects', 'pediatric patients', 'young subjects (<12 years', 'childhood diabetes mellitus and obesity']","['active therapy (twice daily insulin injections plus an annual insulin infusion) or to close observation', 'continuous subcutaneous insulin infusion (CSII']","['severe hypoglycemia', 'risk of developing DM']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0581528', 'cui_str': 'Close observation (regime/therapy)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",339.0,0.0264384,"In general, glycemic control was improved or remained stable, the incidence of severe hypoglycemia was low, and families reported more flexibility in their lifestyle.","[{'ForeName': 'Darrell M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University Medical Center, CA 94305-5208, USA. dwilson@stanford.edu'}]",Journal of pediatric endocrinology & metabolism : JPEM,[]
1130,31888706,Nurse-led care versus physician-led care in the management of rheumatoid arthritis and psoriatic arthritis (StaerkeR): study protocol for a multi-center randomized controlled trial.,"BACKGROUND


In Germany, the care of patients with inflammatory arthritis could be improved. Although specialized rheumatology nurses could take over substantial aspects of patient care, this hardly occurs in Germany. Thus, the aim of the study is to examine structured nursing consultation in rheumatology practices.
METHODS/DESIGN


In total, 800 patients with a stable course of rheumatoid arthritis or psoriatic arthritis in 20 centers in North Rhine-Westphalia and Lower Saxony will be randomized to either nurse-led care or standard care. Participating nurses will study for a special qualification in rheumatology and trial-specific issues. It is hypothesized that nurse-led care is non-inferior to standard care provided by rheumatologists with regard to a reduction of disease activity (DAS28) while it is hypothesized to be superior regarding changes in health-related quality of life (EQ-5D-5L) after 1 year. Secondary outcomes include functional capacity, patient satisfaction with treatment, and resource consumption.
DISCUSSION


Since there is insufficient care of rheumatology patients in Germany, the study may be able to suggest improvements. Nurse-led care has the potential to provide more efficient and effective patient care. This includes a more stringent implementation of the treat-to-target concept, which may lead to a higher percentage of patients reaching their treatment targets, thereby improving patient-related outcomes, such as quality of life, functional capacity, and participation. Additionally, nurse-led care may be highly cost-effective. Finally, this project may form the basis for a sustainable implementation of nurse-led care in standard rheumatology care in Germany.
TRIAL REGISTRATION


German Clinical Trials Register, DRKS00015526. Registered on 11 January 2019.",2019,It is hypothesized that nurse-led care is non-inferior to standard care provided by rheumatologists with regard to a reduction of disease activity (DAS28) while it is hypothesized to be superior regarding changes in health-related quality of life (EQ-5D-5L) after 1 year.,"['patients with inflammatory arthritis', 'rheumatology patients in Germany', '800 patients with a stable course of rheumatoid arthritis or psoriatic arthritis in 20 centers in North Rhine-Westphalia and Lower Saxony']","['nurse-led care or standard care', 'Nurse-led care versus physician-led care']","['functional capacity, patient satisfaction with treatment, and resource consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",800.0,0.0726589,It is hypothesized that nurse-led care is non-inferior to standard care provided by rheumatologists with regard to a reduction of disease activity (DAS28) while it is hypothesized to be superior regarding changes in health-related quality of life (EQ-5D-5L) after 1 year.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mai', 'Affiliation': 'Department of Medical Informatics, Biometry & Epidemiology, Ruhr-University Bochum, 44780, Bochum, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Rheumazentrum Ruhrgebiet, 44652, Herne, Germany.'}, {'ForeName': 'Jens-Peter', 'Initials': 'JP', 'LastName': 'Reese', 'Affiliation': 'Coordinating Center for Clinical Trials of the Philipps-University of Marburg, 35043, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Westerhoff', 'Affiliation': 'BARMER health insurance, 42285, Wuppertal, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Trampisch', 'Affiliation': 'Rheumazentrum Ruhrgebiet, 44652, Herne, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Klaassen-Mielke', 'Affiliation': 'Department of Medical Informatics, Biometry & Epidemiology, Ruhr-University Bochum, 44780, Bochum, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Timmesfeld', 'Affiliation': 'Department of Medical Informatics, Biometry & Epidemiology, Ruhr-University Bochum, 44780, Bochum, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Trampisch', 'Affiliation': 'Department of Medical Informatics, Biometry & Epidemiology, Ruhr-University Bochum, 44780, Bochum, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Krause', 'Affiliation': 'Department of Medical Informatics, Biometry & Epidemiology, Ruhr-University Bochum, 44780, Bochum, Germany. krause@amib.rub.de.'}]",Trials,['10.1186/s13063-019-3808-3']
1131,11838750,Spinal versus general anesthesia for elective cesarean delivery: a prospective comparative study.,"OBJECTIVE


To study the efficacy and safety of spinal anesthesia for elective cesarean section as compared with general anesthesia.
PATIENTS AND METHODS


175 women undergoing elective cesarean section were studied prospectively. They were allocated into two groups; the first group (n=60) received spinal anesthesia, and the second one (n=115) received general anesthesia for elective cesarean section. Preoperative and intraoperative BP and IV fluids were recorded. Chi-Square and Fisher's exact tests were used to compare differences between the two groups; p < 0.05 was considered significant.
RESULTS


There were no differences between the two groups in terms of demographics, indication for elective cesarean section, operative time, gestational age, 1 and 5-min Apgar scores, and the means of preoperative and postoperative systolic and diastolic BP. A statistically significant increase was observed in terms of hypotension, postoperative analgesia, pre-induction and intraoperative IV fluids in the spinal group as compared to the general anesthesia group (p < 0.001, p < 0.01, and p < 0.01, respectively).
CONCLUSION


Spinal anesthesia is as effective as a general anesthesia. Maternal and fetal outcome are favorable. Maternal hypotension can be managed successfully with modest doses of ephedrine and IV fluid infusions. It provides sufficient postoperative analgesia allowing the mother to have more vitality and comfort than those who receive general anesthesia.",2001,"There were no differences between the two groups in terms of demographics, indication for elective cesarean section, operative time, gestational age, 1 and 5-min Apgar scores, and the means of preoperative and postoperative systolic and diastolic BP.",['175 women undergoing elective cesarean section were studied prospectively'],"['Spinal anesthesia', 'ephedrine', 'spinal anesthesia', 'spinal anesthesia, and the second one (n=115) received general anesthesia for elective cesarean section', 'Spinal versus general anesthesia']","['hypotension, postoperative analgesia, pre-induction and intraoperative IV fluids', 'demographics, indication for elective cesarean section, operative time, gestational age, 1 and 5-min Apgar scores, and the means of preoperative and postoperative systolic and diastolic BP', 'Preoperative and intraoperative BP and IV fluids', 'Maternal hypotension']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",175.0,0.0294013,"There were no differences between the two groups in terms of demographics, indication for elective cesarean section, operative time, gestational age, 1 and 5-min Apgar scores, and the means of preoperative and postoperative systolic and diastolic BP.","[{'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Qublan', 'Affiliation': 'Department of Obstetrics and Gynecology, Prince Rhashed Hospital, Irbid-Aidun, Jordan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Merhej', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Dabbas', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Hindawi', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1132,32440730,Prebiotic effect of inulin-type fructans on faecal microbiota and short-chain fatty acids in type 2 diabetes: a randomised controlled trial.,"PURPOSE


Compared to a healthy population, the gut microbiota in type 2 diabetes presents with several unfavourable features that may impair glucose regulation. The aim of this study was to evaluate the prebiotic effect of inulin-type fructans on the faecal microbiota and short-chain fatty acids (SCFA) in patients with type 2 diabetes.
METHODS


The study was a placebo controlled crossover study, where 25 patients (15 men) aged 41-71 years consumed 16 g of inulin-type fructans (a mixture of oligofructose and inulin) and 16-g placebo (maltodextrin) for 6 weeks in randomised order. A 4-week washout separated the 6 weeks treatments. The faecal microbiota was analysed by high-throughput 16S rRNA amplicon sequencing and SCFA in faeces were analysed using vacuum distillation followed by gas chromatography.
RESULTS


Treatment with inulin-type fructans induced moderate changes in the faecal microbiota composition (1.5%, p = 0.045). A bifidogenic effect was most prominent, with highest positive effect on operational taxonomic units (OTUs) of Bifidobacterium adolescentis, followed by OTUs of Bacteroides. Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo. The prebiotic fibre had no effects on the concentration of butyric acid or on the overall microbial diversity.
CONCLUSION


Six weeks supplementation with inulin-type fructans had a significant bifidogenic effect and induced increased concentrations of faecal SCFA, without changing faecal microbial diversity. Our findings suggest a moderate potential of inulin-type fructans to improve gut microbiota composition and to increase microbial fermentation in type 2 diabetes.
TRIAL REGISTRATION


The trial is registered at clinicaltrials.gov (NCT02569684).",2020,"Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo.","['type 2 diabetes', '25 patients (15 men) aged 41-71\xa0years consumed 16\xa0g of inulin-type fructans (a mixture of oligofructose and inulin) and 16-g', 'patients with type 2 diabetes']","['placebo (maltodextrin', 'inulin-type fructans', 'placebo']","['faecal concentrations of total SCFA, acetic acid and propionic acid', 'faecal microbiota and short-chain fatty acids (SCFA', 'faecal microbiota and short-chain fatty acids', 'microbial fermentation', 'faecal microbiota', 'faecal microbiota composition', 'concentrations of faecal SCFA']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456636', 'cui_str': '16G'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016743', 'cui_str': 'Levans'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0033482', 'cui_str': 'Propanoic Acids'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015852', 'cui_str': 'Fermentation'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",,0.0995287,"Significantly higher faecal concentrations of total SCFA, acetic acid and propionic acid were detected after prebiotic consumption compared to placebo.","[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Birkeland', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway. eline.birkeland@ous-hf.no.'}, {'ForeName': 'Sedegheh', 'Initials': 'S', 'LastName': 'Gharagozlian', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kåre I', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Valeur', 'Affiliation': 'Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Måge', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rud', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Aas', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}]",European journal of nutrition,['10.1007/s00394-020-02282-5']
1133,11838756,The value of transvaginal ultrasonography in diagnosis and management of cervical incompetence.,"To determine the value of transvaginal sonography in women with a previous history of second trimester miscarriage due to cervical incompetence, 55 patients were subjected to either elective cervical cerclage or follow-up (every second patient) with weekly evaluations of the cervix by transvaginal ultrasonography. Emergency cerclage was applied when significant cervical changes were noted. All patients were evaluated with cervical cultures and ultrasound. Women with infection, fibroids, uterine malformations and multiple pregnancies were excluded from the study. The study population was divided in two groups. In group I (n=27) elective cerclage was applied during the 14th week. Women in group II (n=28) were subjected to serial weekly evaluations of the cervix by transvaginal ultrasonograms. In 18 cases emergency cerclage was applied due to significant cervical changes. In group I, labor started before the 33rd week in two cases (7.4%), between 33 and 37 weeks in nine (33.3%) and after the 37th week in 16 cases (59.2%). Out of the 18 patients in group II who had cervical cerclage after ultrasonographic evaluation, four (22.2%) delivered before the 33rd week, three (16.6%) between 33 and 37 weeks and 11 (61.1%) after the 37th week. No statistical difference was noted between the two groups referring to pregnancy outcome (p<0.1). We concluded that ultrasound-guided management despite cervical shortening, does not result in unfavorable pregnancy outcome. A significant number of patients can avoid the operation.",2001,No statistical difference was noted between the two groups referring to pregnancy outcome (p<0.1).,"['cervical incompetence', 'women with a previous history of second trimester miscarriage due to cervical incompetence, 55 patients were subjected to either', 'Women with infection, fibroids, uterine malformations and multiple pregnancies']","['transvaginal sonography', 'transvaginal ultrasonography', 'elective cervical cerclage or follow-up (every second patient) with weekly evaluations of the cervix by transvaginal ultrasonography']",[],"[{'cui': 'C0007871', 'cui_str': 'Uterine Cervical Incompetence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0032980', 'cui_str': 'Midtrimester'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0243070', 'cui_str': 'malformations'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C3853999', 'cui_str': 'Cervical cerclage (physical object)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0585312', 'cui_str': 'Every second (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}]",[],55.0,0.0146588,No statistical difference was noted between the two groups referring to pregnancy outcome (p<0.1).,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kassanos', 'Affiliation': '2nd Department of Obstetrics and Gynecology, Aretaieion Hospital, University of Athens, Greece.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Salamalekis', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vitoratos', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Panayotopoulos', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Loghis', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Creatsas', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1134,32440838,"No mesh versus mesh in the treatment of anterior vaginal wall prolapse: prospective, randomised, controlled trial, long-term follow-up.","OBJECTIVES


To compare the efficacy and safety of anterior colporrhaphy (AC) versus transvaginal polypropylene mesh (PM) for the treatment of anterior vaginal wall prolapse (AVWP) at long-term follow-up.
METHODS


Prospective and randomized controlled trial, 100 women with AVWP stage ≥ II assessed by the Pelvic Organ Prolapse Quantification System (POP-Q) underwent AC (control group) or PM insertion (mesh group). At baseline and at 60-month follow-up, safety profile, anatomical outcomes by POP-Q measurements and staging, subjective outcomes and quality of life (QoL) impact by ICIQ (SF and VV) and OAB-V8 questionnaires were assessed RESULTS: 76 women completed the study, 43 in Control versus 33 in Mesh group. Significant improvements were observed in all variables between the 2 times in each group (p < 0.0001), without differences between groups. Objective cure (POP-Q Ba ≤ - 2 and Ba ≤ - 1) occurred in 22 and 36 (51.2 and 83.7%) versus 23 and 31 (69.7 and 93.9%), p = 0.10 and 0.29; and subjective cure (VSS, no vaginal symptom) in 21 (48.8%) versus 17 (51.5%), p = 0.82, respectively, at 60-month follow-up. When adjusted for the other variables, Mesh group showed worse QoL impact due to subjective vaginal symptoms (odds ratio 3.99, CI 95% 1.13; 14.13). AVW asymptomatic mesh exposure occurred in 2 patients (6.06%) in the Mesh group.
CONCLUSIONS


AC and PM provided good overall objective and subjective outcomes for a minimum 60-month follow-up. Vaginal and urinary symptoms improved post-operatively in both groups. Mesh group experienced four times more negative impact on QoL compared to Control at 60-month follow-up.",2020,"Significant improvements were observed in all variables between the 2 times in each group (p < 0.0001), without differences between groups.","['76 women completed the study, 43 in Control versus 33 in Mesh group', '100 women with AVWP stage\u2009≥\u2009II assessed by the', 'anterior vaginal wall prolapse']","['anterior colporrhaphy (AC', 'transvaginal polypropylene mesh (PM', 'Pelvic Organ Prolapse Quantification System (POP-Q) underwent AC (control group) or PM insertion (mesh group']","['AVW asymptomatic mesh exposure', 'QoL', 'Objective cure (POP-Q Ba\u2009≤\u2009-\xa02 and Ba\u2009≤\u2009-\xa01', 'subjective cure (VSS, no vaginal symptom', 'Vaginal and urinary symptoms', 'safety profile, anatomical outcomes by POP-Q measurements and staging, subjective outcomes and quality of life (QoL) impact by ICIQ (SF and VV) and OAB-V8 questionnaires', 'efficacy and safety', 'subjective vaginal symptoms', 'anterior vaginal wall prolapse (AVWP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0425852', 'cui_str': 'Anterior vaginal wall prolapse'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0425852', 'cui_str': 'Anterior vaginal wall prolapse'}]",100.0,0.0890086,"Significant improvements were observed in all variables between the 2 times in each group (p < 0.0001), without differences between groups.","[{'ForeName': 'José Tadeu Nunes', 'Initials': 'JTN', 'LastName': 'Tamanini', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, São Carlos, SP, Brazil.'}, {'ForeName': 'Leonardo Oliveira', 'Initials': 'LO', 'LastName': 'Reis', 'Affiliation': 'Uroscience, Department of Urology, State University of Campinas, Unicamp and Pontifical Catholic University of Campinas, PUC-Campinas, Av. John Boyd Dunlop, Jardim Ipaussurama, Campinas, SP, Brazil. reisleo.l@gmail.com.'}, {'ForeName': 'Mirce Milhomem', 'Initials': 'MM', 'LastName': 'da Mota Tamanini', 'Affiliation': 'Department of Obstetric and Gynecology of Santa Casa, Jaú, SP, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Aquino Castro', 'Affiliation': 'Section of Urogynecology and Pelvic Surgery, Department of Gynecology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Marair Gracio Ferreira', 'Initials': 'MGF', 'LastName': 'Sartori', 'Affiliation': 'Section of Urogynecology and Pelvic Surgery, Department of Gynecology, Federal University of São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Manoel João Batista Castello', 'Initials': 'MJBC', 'LastName': 'Girão', 'Affiliation': 'Section of Urogynecology and Pelvic Surgery, Department of Gynecology, Federal University of São Paulo, São Paulo, SP, Brazil.'}]",International urology and nephrology,['10.1007/s11255-020-02503-0']
1135,30869969,In-session emotional expression predicts symptomatic and panic-specific reflective functioning improvements in panic-focused psychodynamic psychotherapy.,"In panic-focused psychodynamic psychotherapy (PFPP), exploration and interpretation of avoided and conflicted emotions and fantasies surrounding anxiety are thought to promote panic-specific reflective functioning (PSRF), which drives panic disorder improvements. Patient emotional expression within a session may be a marker of engaged processing and experiencing of affectively charged material. Degree of in-session expressed emotion, indicating both verbal and nonverbal emotions, was examined across three early therapy sessions for prediction of subsequent outcomes. We further investigated whether personality disorder traits, theorized to relate to constricted (obsessive-compulsive) or heightened (borderline) emotions, moderated this relationship. Emotional expression in Sessions 2, 5, and 10 of a 24-session PFPP protocol was assessed by blinded observers in 44 patients randomized to PFPP in a two-site randomized controlled trial of psychotherapies for panic disorder. Robust regressions were conducted to examine the relationship between average emotional expression across the measured sessions and symptom and PSRF changes subsequent to the sampled sessions, as well as moderation by personality disorder criteria, controlling for early outcomes. Higher levels of emotional expression across the early sessions predicted greater subsequent symptom and PSRF improvement. Elevations in expression of grief/sadness drove the symptomatic finding. Patients meeting more borderline criteria experienced a smaller and potentially negative relationship between emotional expression and symptom improvement. Emotional expression in PFPP may be an indicator of positive therapy process for patients without comorbid borderline personality traits, predicting prospective improvements in both a key mediator (PSRF) and symptoms. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Emotional expression in Sessions 2, 5, and 10 of a 24-session PFPP protocol was assessed by blinded observers in 44 patients randomized to PFPP in a two-site randomized controlled trial of psychotherapies for panic disorder.","['patients without comorbid borderline personality traits', '44 patients randomized to', 'for panic disorder']","['psychotherapies', 'psychodynamic psychotherapy (PFPP', 'PFPP']","['verbal and nonverbal emotions', 'emotional expression and symptom improvement', 'Emotional expression', 'Higher levels of emotional expression', 'subsequent symptom and PSRF improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C1261382', 'cui_str': 'Psychotherapy, Psychodynamic'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",44.0,0.0393514,"Emotional expression in Sessions 2, 5, and 10 of a 24-session PFPP protocol was assessed by blinded observers in 44 patients randomized to PFPP in a two-site randomized controlled trial of psychotherapies for panic disorder.","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Zeeshan M', 'Initials': 'ZM', 'LastName': 'Huque', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'DeRubeis', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jacques P', 'Initials': 'JP', 'LastName': 'Barber', 'Affiliation': 'Gordon F. Derner School of Psychology.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Milrod', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Dianne L', 'Initials': 'DL', 'LastName': 'Chambless', 'Affiliation': 'Department of Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000215']
1136,11214952,A comparative study of a gonadotropin-releasing hormone agonist and finasteride on idiopathic hirsutism.,"OBJECTIVE


To compare the efficacy of finasteride and GnRH agonist in the treatment of idiopathic hirsutism.
METHODS


Sixty women with hirsutism were randomly assigned to receive either 5 mg of finasteride or long-acting GnRH agonist (depot leuprolide 3.75 mg) intramuscularly monthly for six months.
MAIN OUTCOME MEASURES


Hirsutism scores were measured according to the Ferriman-Gallway scoring system, and side-effects were monitored for six months of treatment. Blood samples were taken at each visit for assessment of endocrine (FSH, LH, estradiol, progesterone, total and free testosterone, androstenedione, DHEAS-S, 17-OH-P. SHBG), biochemical, and hematologic para- meters.
RESULTS


All of the patients treated with finasteride or GnRH agonist showed neither menstrual abnormalities nor side-effects. The mean percent change (+/- SD) in hirsutism scores in the GnRH and finasteride groups was 36% +/- 14% and 14% +/- 11% at six months, respectively. Serum total testosterone, free testosterone, androstenedion and DHEA-S showed a meaningful decrease in patients treated with GnRH agonist. On the other hand, only serum total testosterone and free testosterone levels decreased with finasteride treatment (p < 0.05 and p < 0.0001, respectively).",2000,"Serum total testosterone, free testosterone, androstenedion and DHEA-S showed a meaningful decrease in patients treated with GnRH agonist.","['idiopathic hirsutism', 'Sixty women with hirsutism']","['finasteride and GnRH agonist', 'finasteride or long-acting GnRH agonist (depot leuprolide 3.75 mg) intramuscularly monthly for six months', 'finasteride', 'gonadotropin-releasing hormone agonist and finasteride', 'finasteride or GnRH agonist']","['menstrual abnormalities nor side-effects', 'Ferriman-Gallway scoring system, and side-effects', 'endocrine (FSH, LH, estradiol, progesterone, total and free testosterone, androstenedione, DHEAS-S, 17-OH-P. SHBG), biochemical, and hematologic para- meters', 'serum total testosterone and free testosterone levels', 'hirsutism scores', 'Hirsutism scores', 'Serum total testosterone, free testosterone, androstenedion and DHEA-S']","[{'cui': 'C0342513', 'cui_str': 'Idiopathic hirsutism (disorder)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019572', 'cui_str': 'Hirsutism'}]","[{'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C4517697', 'cui_str': 'Three point seven five'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}]","[{'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0578772', 'cui_str': 'Hirsutism score (observable entity)'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}]",60.0,0.0200971,"Serum total testosterone, free testosterone, androstenedion and DHEA-S showed a meaningful decrease in patients treated with GnRH agonist.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bayhan', 'Affiliation': 'Department of Obstetrics and Gynecology, Dicle University, Diyarbakir Turkey.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bahçeci', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Demirkol', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ertem', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yalinkaya', 'Affiliation': ''}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Erden', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1137,31519668,Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol.,"INTRODUCTION


Endovascular thrombectomy is the standard of care for anterior circulation acute ischaemic stroke (AIS) secondary to emergent large vessel occlusion in patients who qualify. General anaesthesia (GA) or conscious sedation (CS) is usually required to ensure patient comfort and avoid agitation and movement during thrombectomy. However, the question of whether the use of GA or CS might influence functional outcome remains debated. Indeed, conflicting results exist between observational studies with better outcomes associated with CS and small monocentric randomised controlled trials favouring GA. Therefore, we aim to evaluate the effect of CS versus GA on functional outcome and periprocedural complications in endovascular mechanical thrombectomy for anterior circulation AIS.
METHODS AND ANALYSIS


Anesthesia Management in Endovascular Therapy for Ischemic Stroke (AMETIS) trial is an investigator initiated, multicentre, prospective, randomised controlled, two-arm trial. AMETIS trial will randomise 270 patients with anterior circulation AIS in a 1:1 ratio, stratified by centre, National Institutes of Health Stroke Scale (≤15 or >15) and association of intravenous thrombolysis or not to receive either CS or GA. The primary outcome is a composite of functional independence at 3 months and absence of perioperative complication occurring by day 7 after endovascular therapy for anterior circulation AIS. Functional independence is defined as a modified Rankin Scale score of 0-2 by day 90. Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7.
ETHICS AND DISSEMINATION


The AMETIS trial was approved by an independent ethics committee. Study began in august 2017. Results will be published in an international peer-reviewed medical journal.
TRIAL REGISTRATION NUMBER


NCT03229148.",2019,"Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7.
","['270 patients with anterior circulation AIS in a 1:1 ratio, stratified by centre, National Institutes of Health Stroke Scale (≤15\u2009or >15) and association of intravenous thrombolysis or not to receive either', 'Study began in august 2017', 'anterior circulation acute ischaemic stroke', 'patients who qualify']","['endovascular therapy', 'Sedation versus general anaesthesia', 'CS versus GA', 'CS or GA', 'GA or CS', 'General anaesthesia (GA) or conscious sedation (CS']","['arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution', 'composite of functional independence at 3 months and absence of perioperative complication', 'Perioperative complications']","[{'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0079159', 'cui_str': 'Sedation, Moderate'}]","[{'cui': 'C0189586', 'cui_str': 'Puncture of artery'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0155919', 'cui_str': 'Acute pulmonary edema (disorder)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",270.0,0.21187,"Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7.
","[{'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Chabanne', 'Affiliation': 'Department of Perioperative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France rchabanne@chu-clermontferrand.fr.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Fernandez-Canal', 'Affiliation': 'Department of Perioperative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Degos', 'Affiliation': 'Anesthésie et Neuro-Réanimation chirurgicale Babinski, Assistance Publique Hôpitaux de Paris (AP-HP), Groupe Hospitalier Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Lukaszewicz', 'Affiliation': ""Service d'Anesthésie Réanimation, Hospices Civils de Lyon, Hôpital Neurologique Pierre Wertheimer, Lyon, France.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Velly', 'Affiliation': ""Service d'Anesthésie Réanimation, Assistance Publique Hôpitaux de Marseille (AP-HM), Hôpital La Timone, Marseille, France.""}, {'ForeName': 'Segolene', 'Initials': 'S', 'LastName': 'Mrozek', 'Affiliation': 'Anesthesiology and Critical Care Department, Centre Hospitalier Universitaire de Toulouse, Hôpital Pierre-Paul Riquet, Toulouse, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Perrigault', 'Affiliation': ""Service d'Anesthésie Réanimation, Pôle Neurosciences Tête et Cou, CHU de Montpellier, Montpellier, France.""}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Molliex', 'Affiliation': 'Departement Anesthésie Réanimation, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Tavernier', 'Affiliation': 'Pôle Anesthésie Réanimation, Centre Hospitalier Regional Universitaire de Lille, Lille, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dahyot-Fizelier', 'Affiliation': ""Service d'Anesthésie Réanimation, CHU de Poitiers, Poitiers, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Verdonk', 'Affiliation': ""Département d'Anesthésie-Réanimation, Assistance Publique Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Paris, France.""}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Caumon', 'Affiliation': 'Department of Clinical Research and Innovation (DRCI), Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Masgrau', 'Affiliation': 'Department of Clinical Research and Innovation (DRCI), Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Begard', 'Affiliation': 'Department of Perioperative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Chabert', 'Affiliation': 'Department of Neuroradiology, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ferrier', 'Affiliation': 'Department of Neurology, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Anesthesia and Critical Care, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Jean-Etienne', 'Initials': 'JE', 'LastName': 'Bazin', 'Affiliation': 'Department of Perioperative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics Unit of the Department of Clinical Research and Innovation (DRCI), University Hospital CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': 'Department of Perioperative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-027561']
1138,31537557,Can smartphone technology be used to support an effective home exercise intervention to prevent falls amongst community dwelling older adults?: the TOGETHER feasibility RCT study protocol.,"INTRODUCTION


Falls have major implications for quality of life, independence and cost to the health service. Strength and balance training has been found to be effective in reducing the rate/risk of falls, as long as there is adequate fidelity to the evidence-based programme. Health services are often unable to deliver the evidence-based dose of exercise and older adults do not always sufficiently adhere to their programme to gain full outcomes. Smartphone technology based on behaviour-change theory has been used to support healthy lifestyles, but not falls prevention exercise. This feasibility trial will explore whether smartphone technology can support patients to better adhere to an evidence-based rehabilitation programme and test study procedures/outcome measures.
METHODS AND ANALYSIS


A two-arm, pragmatic feasibility randomised controlled trial will be conducted with health services in Manchester, UK. Seventy-two patients aged 50+years eligible for a falls rehabilitation exercise programme from two community services will receive: (1) standard service with a smartphone for outcome measurement only or (2) standard service plus a smartphone including the motivational smartphone app. The primary outcome is feasibility of the intervention, study design and procedures. The secondary outcome is to compare standard outcome measures for falls, function and adherence to instrumented versions collected using smartphone. Outcome measures collected include balance, function, falls, strength, fear of falling, health-related quality of life, resource use and adherence. Outcomes are measured at baseline, 3 and 6-month post-randomisation. Interviews/focus groups with health professionals and participants further explore feasibility of the technology and trial procedures. Primarily analyses will be descriptive.
ETHICS AND DISSEMINATION


The study protocol is approved by North West Greater Manchester East Research Ethics Committee (Rec ref:18/NW/0457, 9/07/2018). User groups and patient representatives were consulted to inform trial design, and are involved in study recruitment. Results will be reported at conferences and in peer-reviewed publications. A dissemination event will be held in Manchester to present the results of the trial. The protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.
TRIAL REGISTRATION NUMBER


ISRCTN12830220; Pre-results.",2019,"This feasibility trial will explore whether smartphone technology can support patients to better adhere to an evidence-based rehabilitation programme and test study procedures/outcome measures.
","['community dwelling older adults', 'Seventy-two patients aged 50+years eligible for a falls rehabilitation exercise programme from two community services will receive: (1']","['exercise intervention', 'Strength and balance training', 'smartphone technology', 'standard service with a smartphone for outcome measurement only or (2) standard service plus a smartphone including the motivational smartphone app']","['falls, function and adherence to instrumented versions collected using smartphone', 'balance, function, falls, strength, fear of falling, health-related quality of life, resource use and adherence']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0009482', 'cui_str': 'Services, Community'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",72.0,0.120959,"This feasibility trial will explore whether smartphone technology can support patients to better adhere to an evidence-based rehabilitation programme and test study procedures/outcome measures.
","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hawley-Hague', 'Affiliation': 'Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health and Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK helen.hawley-hague@manchester.ac.uk.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Tacconi', 'Affiliation': 'Health Sciences and Technologies-Interdepartmental Center for Industrial Research, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Sabato', 'Initials': 'S', 'LastName': 'Mellone', 'Affiliation': 'Health Sciences and Technologies-Interdepartmental Center for Industrial Research, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Easdon', 'Affiliation': 'Pennine Care NHS Foundation Trust, Ashton-under-Lyne, UK.'}, {'ForeName': 'Fan Bella', 'Initials': 'FB', 'LastName': 'Yang', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Ting-Li', 'Initials': 'TL', 'LastName': 'Su', 'Affiliation': 'Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'A Stefanie', 'Initials': 'AS', 'LastName': 'Mikolaizak', 'Affiliation': 'Department of Clinical Gerontology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Chiari', 'Affiliation': 'Health Sciences and Technologies-Interdepartmental Center for Industrial Research, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Jorunn L', 'Initials': 'JL', 'LastName': 'Helbostad', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Todd', 'Affiliation': 'Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health and Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK.'}]",BMJ open,['10.1136/bmjopen-2018-028100']
1139,10668157,Intramuscular versus vaginal administration of progesterone for luteal phase support after in vitro fertilization and embryo transfer. A comparative randomized study.,"A total of 156 patients were randomly treated with exogenous natural progesterone (intramuscularly, 50 mg/day) and vaginal gel (90 mg/day) P or nothing (Controls) from the day before embryo transfer (ET) for two weeks. In case of positive beta-HCG, the treatment was continued for 12 weeks. Plasma P and 17 beta-Estradiol concentrations were estimated and compared with the control not supplemented group. Both treatments were able to increase significantly the luteal plasmatic values of P versus controls. The ongoing pregnancy and the living birth rates per transfer were significantly higher in the patients supplemented with intramuscular P than in those treated with vaginal gel P. The intramuscular natural P appears the most suitable route of administration for luteal phase support in IVF-ET procedures.",1999,The ongoing pregnancy and the living birth rates per transfer were significantly higher in the patients supplemented with intramuscular P than in those treated with vaginal gel,['156 patients'],"['vaginal gel', 'progesterone', 'exogenous natural progesterone']","['Plasma P and 17 beta-Estradiol concentrations', 'luteal plasmatic values', 'living birth rates per transfer']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042257', 'cui_str': 'Vaginal Jelly'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",156.0,0.0135682,The ongoing pregnancy and the living birth rates per transfer were significantly higher in the patients supplemented with intramuscular P than in those treated with vaginal gel,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abate', 'Affiliation': 'EFRA Italy (European Fertility Research Associates), Center of Human Reproduction, Messina, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Perino', 'Affiliation': ''}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Abate', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brigandì', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Costabile', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Manti', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1140,32439573,"A commentary on: ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - an open labelled, randomised control trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.0957589,,"[{'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Aneurin Bevan University Health Board, Newport, Wales, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, Wales, United Kingdom; Department of Surgical Research and Education, Institute of Clinical Sciences, Gothenburg University, Gothenburg, 41345, Sweden. Electronic address: beamishaj@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.041']
1141,32439823,Slowed Metabolic Decline After 1 Year of Oral Insulin Treatment Among Individuals at High Risk for Type 1 Diabetes in the Diabetes Prevention Trial-Type 1 (DPT-1) and TrialNet Oral Insulin Prevention Trials.,"We assessed whether oral insulin slowed metabolic decline after 1 year of treatment in individuals at high risk for type 1 diabetes. Two oral insulin trials that did not show efficacy overall and had type 1 diabetes as the primary end point were analyzed: the Diabetes Prevention Trial-Type 1 (DPT-1) and the TrialNet oral insulin trials. Oral glucose tolerance tests at baseline and after 1 year of treatment were analyzed. Among those at high risk (with a Diabetes Prevention Trial-Type 1 Risk Score [DPTRS] ≥6.75), the area under the curve (AUC) C-peptide increased significantly from baseline to 1 year in each oral insulin group, whereas the AUC glucose increased significantly in each placebo group. At 1 year, the AUC C-peptide/AUC glucose (AUC Ratio) was significantly higher in the oral insulin group than in the placebo group in each trial ( P  < 0.05;  P  = 0.057 when adjusted for age in the TrialNet trial) and in both trials combined ( P  < 0.01 with or without adjustment for age). For a DPTRS <6.75, oral insulin groups did not differ from placebo groups in the AUC Ratio. The findings suggest that 1 year of treatment with oral insulin slows metabolic deterioration in individuals at high risk for type 1 diabetes. Moreover, the findings further suggest that metabolic end points can be useful adjuncts to the diagnostic end point in assessments of preventive treatments for the disorder.",2020,AUC glucose was significantly higher (p<0.05) in the oral insulin group than in the placebo group in each trial,['individuals at high risk for type 1 diabetes'],"['oral insulin', 'placebo']","['AUC glucose', 'Slowed Metabolic Decline', 'AUC C-peptide', 'Oral glucose tolerance tests']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",,0.112215,AUC glucose was significantly higher (p<0.05) in the oral insulin group than in the placebo group in each trial,"[{'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Sosenko', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL jsosenko@med.miami.edu.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Skyler', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Desmond A', 'Initials': 'DA', 'LastName': 'Schatz', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Haller', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pugliese', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cleves', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Geyer', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Rafkin', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Matheson', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Palmer', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db20-0166']
1142,11491366,Presence of LH in gonadotropins associated with higher IVF pregnancy rates when basal serum LH is increased.,"PURPOSE


To determine if pregnancy rates following in vitro fertilization-embryo transfer (IVF-ET) correlate with the presence or not of luteinizing hormone (LH) in the gonadotropins used for stimulation. Furthermore to see if the early follicular phase serum LH level affects pregnancy outcome according to the type of gonadotropins used.
METHODS


The type of gonadotropins were prescribed randomly according to finances and convenience. Serum LH was obtained on day 2 or 3 of the menstrual cycle.
RESULTS


When LH was > the median, significantly higher pregnancy rates were obtained in those treated with the follicle stimulating hormone (FSH)/human menopausal gonadotropin combination. When LH was < or = the median, significantly more oocytes were retrieved with FSH exclusively. No confounding variables were found to explain the data.
CONCLUSIONS


Considering concerns of published studies that LH may have a toxic effect on pregnancy outcome, and if LH is suppressed too low, gonadotropins with exclusive FSH may not stimulate sufficient oocytes, the results were opposite to expectations.",2001,"When LH was > the median, significantly higher pregnancy rates were obtained in those treated with the follicle stimulating hormone (FSH)/human menopausal gonadotropin combination.",[],['vitro fertilization-embryo transfer (IVF-ET'],"['IVF pregnancy rates', 'Serum LH', 'pregnancy rates']",[],"[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0738733,"When LH was > the median, significantly higher pregnancy rates were obtained in those treated with the follicle stimulating hormone (FSH)/human menopausal gonadotropin combination.","[{'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Check', 'Affiliation': 'The University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School at Camden, Cooper Hospital/University Medical Center Department of Obstetrics and Gynecology, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Check', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nazari', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Davies', 'Affiliation': ''}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Choe', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1143,11214945,Adrenalin versus terlipressin: blood loss and cardiovascular side-effects in the vaginal part of laparoscopically-assisted vaginal hysterectomy or vaginal hysterectomy.,"The purpose of the study was to compare blood loss and cardiovascular side-effects in the course of the vaginal part of laparoscopically-assisted vaginal hysterectomy (LAVH) or single vaginal hysterectomy (VH) [1]. Blood loss was evaluated in relation to local application of two haemostatic agents, e.g. adrenalin as a gold standard versus terlipressin. The investigation was designed as a prospective randomised study. A prospective group of 40 patients selected for LAVH or VH was randomised into two groups, e.g. 20 patients in each group. In both of these groups, the blindly selected haemostatic agent was applied locally immediately before circular colpotomy, the surgeon not being aware which agent was being used. Because of the claimed delayed effect of terlipressin a third group of another 20 patients was randomly selected. For comparison in this group terlipressin was locally already applied before the laparoscopic part of LAVH, e.g. 20-25 minutes before performing circular colpotomy. Thus, this particular group could not be made blind to the surgeon. The study confirmed a significantly superior haemostatic effect of adrenalin. On the other hand after the adrenalin application a higher frequency of hypertensive reactions and mild arrythmias were observed but without any clinical seguelae.",2000,On the other hand after the adrenalin application a higher frequency of hypertensive reactions and mild arrythmias were observed but without any clinical seguelae.,"['40 patients selected for LAVH or VH was randomised into two groups, e.g. 20 patients in each group', 'vaginal part of laparoscopically-assisted vaginal hysterectomy or vaginal hysterectomy']","['single vaginal hysterectomy (VH', 'laparoscopically-assisted vaginal hysterectomy (LAVH', 'Adrenalin versus terlipressin']","['Blood loss', 'blood loss and cardiovascular side-effects', 'hypertensive reactions and mild arrythmias']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1268131', 'cui_str': 'Vaginal part'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0020700', 'cui_str': 'Colpohysterectomy'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0020700', 'cui_str': 'Colpohysterectomy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1963284', 'cui_str': 'Adrenalin'}, {'cui': 'C0145185', 'cui_str': 'terlipressin'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]",40.0,0.0309611,On the other hand after the adrenalin application a higher frequency of hypertensive reactions and mild arrythmias were observed but without any clinical seguelae.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bartos', 'Affiliation': 'Department of Anaesthesiology, Na Homolce Hospital, Prague, Czech Republic.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Popelka', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Adamcová', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Struppl', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1144,32440409,Does Realism Matter? A Randomized Controlled Trial Comparing Models for Medical Student Suture Education.,"Background


We hypothesized that medical students trained in suturing using high-fidelity models (cadaveric tissue) would demonstrate greater proficiency when compared with those trained using low-fidelity models (synthetic tissue).
Methods


Forty-three medical students were randomized into 2 groups. Group 1 consisted of students taught to perform simple interrupted sutures using synthetic tissue, and group 2 consisted of those taught using human cadaveric tissue. Suturing proficiency was measured pre- and postinstruction using the Global Rating Scale and by measuring suture accuracy. Perceived confidence in suturing was measured on a scale of 0-100.
Results


Perceived confidence was measured as an average of 8.26 out of 100 pretraining and significantly improved after training (56.91 out of 100); however, there was no significant difference when comparing confidence between groups posttraining (57.65 cadaveric versus 56.05 synthetic;  P  = 0.78), nor in the measured confidence change pre- and posttraining ( P  = 0.53). Posttraining, participants displayed a significant improvement in the number of adequately placed sutures; however, there was no significant difference posttraining when comparing groups (2.43 cadaveric versus 2.75 synthetic;  P  = 0.48). The change in adequate suture placement pre- and posttraining did not reach statistical significance between groups ( P  = 0.27). After instruction, participants demonstrated a significant improvement in total suture performance scores; however, there was no significant difference when comparing groups (30.04 cadaveric versus 29.80 synthetic;  P  = 0.90), nor in the total change pre- and posttraining ( P  = 0.74).
Conclusions


Training medium fidelity (tissue versus synthetic) does not significantly influence a student's overall suturing performance. However, formal instruction significantly improves objective competence and perceived confidence. Regardless of the model, surgical departments should emphasize medical student exposure to basic surgical skills education.",2020,"Posttraining, participants displayed a significant improvement in the number of adequately placed sutures; however, there was no significant difference posttraining when comparing groups (2.43 cadaveric versus 2.75 synthetic;  P  = 0.48).","['Methods\n\n\nForty-three medical students', 'Medical Student Suture Education']","['students taught to perform simple interrupted sutures using synthetic tissue, and group 2 consisted of those taught using human cadaveric tissue']","['Global Rating Scale', 'Perceived confidence in suturing', 'total suture performance scores', 'objective competence and perceived confidence', 'number of adequately placed sutures']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",100.0,0.0412224,"Posttraining, participants displayed a significant improvement in the number of adequately placed sutures; however, there was no significant difference posttraining when comparing groups (2.43 cadaveric versus 2.75 synthetic;  P  = 0.48).","[{'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Blau', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Ronnie L', 'Initials': 'RL', 'LastName': 'Shammas', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Anolik', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Yash J', 'Initials': 'YJ', 'LastName': 'Avashia', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Krucoff', 'Affiliation': 'Division of Plastic, Maxillofacial, and Oral Surgery, Duke University Hospital, Durham, N.C.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zenn', 'Affiliation': 'Zenn Plastic Surgery, Raleigh, N.C.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002738']
1145,10758792,A randomized trial of pulsatile vs continuous oxytocin infusion for labor induction.,"In a prospective randomized study, 560 pregnant women were subjected to labor induction with continuous or pulsed intravenous oxytocin infusion. There were no significant differences with respect to maternal history, Bishop score and perinatal morbidity. The mean induction to delivery interval was shorter in the pulsed infusion group than in the continuous infusion group (325 +/- 63 vs 433 +/- 67 min in primiparous, p < 0.001 and 204 +/- 52 vs 236 +/- 87 min in multiparous women, p < 0.01). The mean amount of oxytocin administered in the pulsed infusion group was also significantly lower than in the continuous infusion group (4.7 +/- 0.6 mU/min versus 9.6 +/- 3.4 mU/min in primiparous, p < 0.001 and 2.1 +/- 0.4 mU/min versus 5.2 +/- 2.3 mU/min in multiparous women, p < 0.001). Our study demonstrates that pulsatile administration of oxytocin is as safe as continuous intravenous infusion, requires less oxytocin and is more effective as it reduces labor duration.",2000,The mean amount of oxytocin administered in the pulsed infusion group was also significantly lower than in the continuous infusion group (4.7 +/-,"['labor induction', '560 pregnant women']","['labor induction with continuous or pulsed intravenous oxytocin infusion', 'pulsatile vs continuous oxytocin', 'oxytocin']","['mean amount of oxytocin', 'maternal history, Bishop score and perinatal morbidity', 'mean induction to delivery interval']","[{'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",560.0,0.0347423,The mean amount of oxytocin administered in the pulsed infusion group was also significantly lower than in the continuous infusion group (4.7 +/-,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Salamalekis', 'Affiliation': '2nd Department of Obstetrics and Gynecology, University of Athens, Areteion Hospital, Greece.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vitoratos', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kassanos', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Loghis', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Panayotopoulos', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sykiotis', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1146,10758794,The role of antibiotics after dilatation and curettage in women with metrorrhagia in the prevention of pelvic inflammatory disease.,"A follow-up study was carried out in 67 healthy women with negative vaginal-cervical cultures after an endometrial curettage for metrorrhagia. The women were separated into two treatment groups and clinically followed for one month after the operation. The first group included 33 women (aged 23-67, mean 43) who received doxycycline 200 mg daily for a period of one week after the procedure. The second group included 34 women (aged 28-70, mean 43.5) who did not receive any antibiotic regimen after the dilatation and curettage. Four and three women from the 1st and 2nd group, respectively, developed PID during follow-up; a difference not statistically significant.",2000,A follow-up study was carried out in 67 healthy women with negative vaginal-cervical cultures after an endometrial curettage for metrorrhagia.,"['33 women (aged 23-67, mean 43) who received', '34 women (aged 28-70, mean 43.5) who did not receive any antibiotic regimen after the dilatation and curettage', '67 healthy women with negative vaginal-cervical cultures after an endometrial curettage for metrorrhagia', 'women with metrorrhagia in the prevention of pelvic inflammatory disease']","['doxycycline', 'antibiotics after dilatation and curettage']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0012358', 'cui_str': 'D&C'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0855646', 'cui_str': 'Cervical culture'}, {'cui': 'C1610084', 'cui_str': 'Endometrial curettage'}, {'cui': 'C0025874', 'cui_str': 'Dysfunctional Uterine Bleeding'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0242172', 'cui_str': 'Pelvic Inflammatory Disease'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0012358', 'cui_str': 'D&C'}]",[],67.0,0.0229153,A follow-up study was carried out in 67 healthy women with negative vaginal-cervical cultures after an endometrial curettage for metrorrhagia.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Makris', 'Affiliation': '1st Department of Obstetrics and Gynecology, University of Athens, Alexandra Hospital, Greece.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Iatrakis', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sakellaropoulos', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rodolakis', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Michalas', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1147,10668163,Inhibitory effect of exogenous oxytocin on ACTH and cortisol secretion during labour.,"Complex mechanisms which are still not completely defined, are responsible for the spontaneous onset of labour: an essential role is attributed to endocrine factors. A massive increase, even three times higher than normal physiological values of ACTH and cortisol, has been reported during labour. Similar behaviour has also been recorded for oxytocin at the end of pregnancy as well as during labour. The relationship between oxytocin and the adrenal axis are still debated thus the goal of our study was to attempt to clarify this rapport. Sixty-two women at the end of a term-pregnancy agreed to participate in this study: 46 were innoculated with oxytocin (syntocinon) every 20 minutes for 1 hour; 16 were administered a natural placebo every 20 minutes for 1 hour (control group). ACTH and cortisol values from plasma samples were taken every 20 minutes and analyzed. Our results demonstrated an inhibitory effect of exogenous oxytocin on ACTH and cortisol release. This inhibitory effect, as shown by our results, is time and dose-related. High oxytocin levels, as during exogenous infusion, could induce an effect opposite a normal physiologic one.",1999,"Complex mechanisms which are still not completely defined, are responsible for the spontaneous onset of labour: an essential role is attributed to endocrine factors.",['Sixty-two women at the end of a term-pregnancy agreed to participate in this study: 46 were innoculated with'],"['exogenous oxytocin', 'natural placebo', 'oxytocin', 'oxytocin (syntocinon']","['ACTH and cortisol release', 'ACTH and cortisol values', 'ACTH and cortisol secretion']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0592155', 'cui_str': 'Syntocinon'}]","[{'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]",62.0,0.0232359,"Complex mechanisms which are still not completely defined, are responsible for the spontaneous onset of labour: an essential role is attributed to endocrine factors.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Izzo', 'Affiliation': 'II University of Naples, Gynecology and Obstetrics Institute, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rotondi', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Perone', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lauro', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Manzo', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Casilli', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rasile', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Amato', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1148,31454771,"Randomized, controlled crossover study of IVIg for demyelinating polyneuropathy and diabetes.","OBJECTIVE


To determine whether IV immunoglobulin (IVIg) is more effective than placebo at reducing disability in patients with diabetes and demyelinating polyneuropathy features.
METHODS


This is a double-blinded, single-center, randomized, controlled crossover trial of IVIg treatment vs placebo. The primary outcome measure was the mean change in Overall Neuropathy Limitation Scale (ONLS) scores during the IVIg phasecompared with the placebo phase. Secondary outcomes include changes in the Rasch-built Overall Disability Scale, Medical Research Council sum scores, grip strength, electrophysiologic measurements, quality of life, and adverse effects.
RESULTS


Twenty-five subjects were recruited between March 2015 and April 2017. The mean change in ONLS scores was -0.2 points during the IVIg phase and 0.0 points during the placebo phase ( p  = 0.23). Secondary outcomes did not show significant differences between IVIg and placebo.
CONCLUSIONS


IVIg did not reduce disability, improve strength, or quality of life in patients with demyelinating polyneuropathy features and diabetes after 3 months of treatment in comparison with placebo. Therefore, careful consideration of the primary diagnosis is required before immunomodulatory therapy.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that for patients with diabetes and demyelinating polyneuropathy features, IVIg did not significantly reduce disability.",2019,"CONCLUSIONS


IVIg did not reduce disability, improve strength, or quality of life in patients with demyelinating polyneuropathy features and diabetes after 3 months of treatment in comparison with placebo.","['Twenty-five subjects were recruited between March 2015 and April 2017', 'patients with diabetes and demyelinating polyneuropathy features', 'patients with diabetes', 'demyelinating polyneuropathy and diabetes']","['placebo', 'IV immunoglobulin (IVIg']","['changes in the Rasch-built Overall Disability Scale, Medical Research Council sum scores, grip strength, electrophysiologic measurements, quality of life, and adverse effects', 'mean change in Overall Neuropathy Limitation Scale (ONLS) scores', 'mean change in ONLS scores', 'disability, improve strength, or quality of life']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",25.0,0.538441,"CONCLUSIONS


IVIg did not reduce disability, improve strength, or quality of life in patients with demyelinating polyneuropathy features and diabetes after 3 months of treatment in comparison with placebo.","[{'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Breiner', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia. abreiner@toh.ca.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Barnett Tapia', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Leif Erik', 'Initials': 'LE', 'LastName': 'Lovblom', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Hans D', 'Initials': 'HD', 'LastName': 'Katzberg', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'From the Division of Neurology (A.B.), Department of Medicine, the Ottawa Hospital; Ottawa Hospital Research Institute (A.B.); Division of Neurology (C.B., H.D.K., V.B.), Department of Medicine, Ellen and Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto; Division of Endocrinology and Metabolism (L.E.L., B.A.P.), Department of Medicine, Mount Sinai, Hospital and Lunenfeld Tanenbaum Research Institute, University of Toronto, Canada; and Institute for Research and Medical Consultations (V.B.), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000586']
1149,31454777,Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE).,"OBJECTIVE


To evaluate the safety and efficacy of cholecalciferol in patients with relapsing-remitting MS (RRMS).
METHODS


In this double-blind, placebo-controlled parallel-group, 2-year study, 181 patients with RRMS were randomized 1:1. Key inclusion criteria were a low serum 25-hydroxy vitamin D (25OHD) concentration (<75 nmol/L), a treatment with interferon beta-1a 44 μg (SC 3 times per week) 4 months ± 2 months before randomization, and at least one documented relapse during the previous 2 years. Patients received high-dose oral cholecalciferol 100,000 IU or placebo every other week for 96 weeks. Primary outcome measure was the change in the annualized relapse rate (ARR) at 96 weeks. Secondary objectives included safety and tolerability of cholecalciferol and efficacy assessments (ARR, MRI parameters, and Expanded Disability Status Scale [EDSS]).
RESULTS


The primary end point was not met. In patients who completed the 2-year follow-up (45 with cholecalciferol and 45 with placebo), all efficacy parameters favored cholecalciferol with an ARR reduction ( p  = 0.012), less new hypointense T1-weighted lesions ( p  = 0.025), a lower volume of hypointense T1-weighted lesions ( p  = 0.031), and a lower progression of EDSS ( p  = 0.026). The overall rate of adverse events was well balanced between groups.
CONCLUSIONS


Although the primary end point was not met, these data suggest a potential treatment effect of cholecalciferol in patients with RRMS already treated with interferon beta-1a and low serum 25OHD concentration. Together with the good safety profile, these data support the exploration of cholecalciferol treatment in such patients with RRMS.
CLINICALTRIALSGOV IDENTIFIER


NCT01198132.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for patients with RRMS and low serum 25OHD, cholecalciferol did not significantly affect ARRs.",2019,"The overall rate of adverse events was well balanced between groups.
","['patients with relapsing-remitting MS (RRMS', 'patients with RRMS already treated with interferon beta-1a and low serum 25OHD concentration', 'relapsing-remitting MS', '75 nmol/L), a treatment with interferon beta-1a 44 μg ', '181 patients with RRMS']","['placebo', 'cholecalciferol', 'Cholecalciferol', 'high-dose oral cholecalciferol 100,000 IU or placebo']","['safety and tolerability of cholecalciferol and efficacy assessments (ARR, MRI parameters, and Expanded Disability Status Scale [EDSS', 'low serum 25-hydroxy vitamin D (25OHD) concentration', 'ARR reduction', 'annualized relapse rate (ARR', 'overall rate of adverse events', 'new hypointense T1-weighted lesions', 'lower volume of hypointense T1-weighted lesions', 'lower progression of EDSS', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",181.0,0.116533,"The overall rate of adverse events was well balanced between groups.
","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Camu', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France. w-camu@chu-montpellier.fr.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lehert', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pierrot-Deseilligny', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Hautecoeur', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Besserve', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Jean Deleglise', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Payet', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Thouvenot', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Souberbielle', 'Affiliation': 'From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.'}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000597']
1150,10459447,Ovarian stimulation using a new highly purified urinary FSH: a prospective randomized clinical study.,"The aim of this study was to determine the effectiveness of a new highly purified urinary FSH. A total of 60 in vitro-fertilization (IVF) patients, undergoing embryo transfer (ET) for the first time, were randomly allocated into two groups: Group A (n = 30). Subcutaneous administration of urinary follicle-stimulating hormone (FSH, Fostimon 75, A.M.S.A., Italy). Group B (n = 30). Subcutaneous administration of urinary follicle-stimulating hormone (FSH, Metrodin 75 HP, Serono, Italy). Statistical analysis was performed using the chi-square test, p < 0.05 was assumed as significant. This prospective randomized clinical study in an IVF-ET program showed that both drugs were equally safe and effective. Except for the number of the high quality embryos (3.16 vs 2.9; p = 0.03) the two groups did not differ in stimulation parameters or clinical pregnancy rates per attempt and per transfer. On the other hand, a mean number of 3.56 vs 2.18 embryos were cryopreserved in group A and in group B, respectively, as a result of the high number of mature oocytes and high quality embryos. When frozen embryos cycles were included, the difference in pregnancy rate became significant.",1999,Except for the number of the high quality embryos (3.16 vs 2.9; p = 0.03) the two groups did not differ in stimulation parameters or clinical pregnancy rates per attempt and per transfer.,"['A total of 60 in vitro-fertilization (IVF) patients, undergoing embryo transfer (ET) for the first time']","['urinary follicle-stimulating hormone (FSH, Metrodin 75 HP, Serono, Italy', 'urinary follicle-stimulating hormone (FSH', 'Ovarian stimulation using a new highly purified urinary FSH']",['pregnancy rate'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C1720853', 'cui_str': 'Metrodin'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",,0.031258,Except for the number of the high quality embryos (3.16 vs 2.9; p = 0.03) the two groups did not differ in stimulation parameters or clinical pregnancy rates per attempt and per transfer.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gerli', 'Affiliation': 'Gynecological and Obstetric Institute, University of Perugia, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Perino', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abate', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Costabile', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gholami', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vitiello', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1151,31947038,Using Virtual Reality to Examine the Neural and Physiological Responses to Height and Perturbations in Quiet Standing.,"We describe an experimental setup, which uses virtual reality to understand neural responses to height and perturbations in human postural control. This system could help clinicians develop better methods to alleviate symptoms from a significant fear of heights, especially in the elderly and those with movement disorders, such as Parkinson's disease. In our design, EEG and EKG systems monitor the participants' neural responses and heart activities respectively, while they try to maintain balance on a force plate in an induced virtual world, experiencing randomized height changes and perturbations. These responses are then analyzed to understand the participants' anxiety caused by height and postural challenges.",2019,"This system could help clinicians develop better methods to alleviate symptoms from a significant fear of heights, especially in the elderly and those with movement disorders, such as Parkinson's disease.",[],[],[],[],[],[],,0.0199412,"This system could help clinicians develop better methods to alleviate symptoms from a significant fear of heights, especially in the elderly and those with movement disorders, such as Parkinson's disease.","[{'ForeName': 'Rachneet', 'Initials': 'R', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Rongyi', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Liran', 'Initials': 'L', 'LastName': 'Ziegelman', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sowers', 'Affiliation': ''}, {'ForeName': 'Manuel E', 'Initials': 'ME', 'LastName': 'Hernandez', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2019.8857647']
1152,32439422,Development and piloting of a blended learning training programme for physicians and medical students to enhance their competences in evidence-based decision-making.,"INTRODUCTION


In 2016, the German Network for Evidence-based Medicine revised its basic curriculum for competences in evidence-based medicine. A curriculum-based training programme for physicians and medical students to enhance their competences in evidence-based decision-making was developed. The training programme was planned on the basis of problem-based learning. The aim of this qualitative pilot study was to explore the feasibility and acceptability of the training programme. Hypotheses concerning its influence on critical health literacy and the attitude toward evidence-based decision-making were to be generated.
METHODS


Participating healthcare professionals received a structured training in a blended learning format. Data collection was conducted during the training sessions. The lessons were observed and protocolled and the working results were documented. Two focus group interviews were conducted after the training blocks with focus on acceptability and feasibility of the training programme. Interview transcripts and protocols were analysed using qualitative content analysis according to Mayring. Data saturation was intended by an iterative process of testing, analysing and revising the training programme. In addition, critical health literacy was assessed using the validated Critical Health Competence test. Levels of competence were calculated to measure the effect of the training on critical health competences.
RESULTS


Two pilot courses with 29 physicians and other healthcare professionals were conducted between January and March 2019. Overall, the training programme proved to be feasible. The participants rated the comprehensibility of the learning modules as high. However, the practical exercises (e.g. role plays in shared decision-making) revealed that relevant subjects were insufficiently understood (e.g. the difference between the benefits and harms of a diagnostic test and its test accuracy). The interactive instructional design was appreciated. The participants appraised the work tasks as comprehensible but also challenging and requested a theoretical introduction to statistical terms in preparation for work tasks. The programme was revised iteratively according to the results. Critical health competences increased significantly after the training. Mean values (±SD) of levels of competence were 571.21 (±82.87) before training and 671.90 (±51.38) after training (p<0.0001) (levels of competence with a range from 0 to 1,000).
CONCLUSION


The training programme is feasible and was well accepted by the participants. It should be established as a continuing medical education opportunity for practitioners. Evaluation in a randomised controlled trial is recommended. Furthermore, the training can easily be adapted for interprofessional training. A concept for long-term implementation is needed.",2020,Critical health competences increased significantly after the training.,"['physicians and medical students', 'Participating healthcare professionals', '29 physicians and other healthcare professionals were conducted between January and March 2019']","['curriculum-based training programme', 'structured training in a blended learning format', 'blended learning training programme']","['feasibility and acceptability', 'Critical health competences', 'Mean values (±SD) of levels of competence']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0398525,Critical health competences increased significantly after the training.,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hinneburg', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. Electronic address: jana.hinneburg@medizin.uni-halle.de.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hecht', 'Affiliation': 'School of Nursing Science, Faculty of Health, University of Witten/Herdecke, Witten/Herdecke, Germany. Electronic address: hecht@red-institut.de.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Berger-Höger', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Buhse', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lühnen', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Steckelberg', 'Affiliation': 'Institute for Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}]","Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen",['10.1016/j.zefq.2020.02.004']
1153,11530870,The effect of antenatal corticosteroid therapy on pregnancies complicated by premature rupture of membranes.,"UNLABELLED


This study was carried out to examine the effect of antenatal corticosteroid therapy on pregnancies complicated by premature rupture of membranes (PROMs). For this purpose, 139 patients with a singleton pregnancy (27-34 weeks of gestation) complicated by PROMs were evaluated prospectively during the period January 1997 to February 1999 at two Jordanian military hospitals (Prince Rhashed and Prince Zaid). Patients were allocated into two groups; Group 1 included 72 patients treated with dexamethsone (24 mg divided into 4 doses 12 hours apart), and Group 2 which included 67 patients whoreceived no treatment (control group). All women were examined clinically and the diagnosis of PROMs was demonstrated using vaginal speculum, nitrazine paper examination and ultrasonography. All neonates were evaluated clinically, radiologically, and by laboratory investigations. Pearson's Chi-square and Fisher's exact tests were used to assess the significance of differences between the two study groups. Respiratory distress syndrome (RDS), necrotizing enterocolitis (NEC), intraventricular haemorrhage (IVH), and days of hospital stay were significantly reduced in premature infants of the corticosteroid treated women compared with the controls (p<0.04, p<0.04, p<0.04, and p<0.05, respectively). The perinatal mortality was significantly decreased among the corticosteroid treated group in the gestational subgroups 31-32 and 33-34 weeks (p<0.04), and in all birth weight subgroups (p<0.03). RDS was statistically a significant factor which resulted in increased perinatal mortality in the control group (p=0.02). Regarding the occurrence of postpartum endometritis there was a statistically significant increase among the corticosteroid treated group compared with the controls (p<0.04).
CONCLUSION


Antenatal corticosteroid therapy in pregnancies complicated by PROMs has a positive influencing effect on premature infants between 31 and 34 weeks of gestation, decreasing significantly the perinatal morbidity and mortality. It should be used with particular relevance to the developing world where surfactant is not available or where neonatal intensive care units are lacking.",2001,"The perinatal mortality was significantly decreased among the corticosteroid treated group in the gestational subgroups 31-32 and 33-34 weeks (p<0.04), and in all birth weight subgroups (p<0.03).","['pregnancies complicated by premature rupture of membranes', '139 patients with a singleton pregnancy (27-34 weeks of gestation) complicated by PROMs were evaluated prospectively during the period January 1997 to February 1999 at two Jordanian military hospitals (Prince Rhashed and Prince Zaid', 'pregnancies complicated by premature rupture of membranes (PROMs']","['corticosteroid', 'dexamethsone', 'antenatal corticosteroid therapy']","['perinatal morbidity and mortality', 'occurrence of postpartum endometritis', 'Respiratory distress syndrome (RDS), necrotizing enterocolitis (NEC), intraventricular haemorrhage (IVH), and days of hospital stay', 'perinatal mortality']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}]",139.0,0.0353788,"The perinatal mortality was significantly decreased among the corticosteroid treated group in the gestational subgroups 31-32 and 33-34 weeks (p<0.04), and in all birth weight subgroups (p<0.03).","[{'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Qublan', 'Affiliation': ''}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Malkawi', 'Affiliation': ''}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Hiasat', 'Affiliation': ''}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Hindawi', 'Affiliation': ''}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Al-Taani', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Abu-Khait', 'Affiliation': ''}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Al-Maaitah', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1154,11491379,Beneficial effects of low doses of ethinyl-estradiol on the lipid profile in postmenopausal women.,"The purpose of this study was to investigate the beneficial effects of low doses of ethinyl-estradiol on the lipid profile in postmenopausal women. One hundred and five patients (mean age [+/-S D] 42.9 +/- 5.0 years) who underwent a hysterectomy and bilateral salpingo-oophorectomy were included in the study. For the present study serum levels of total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, apolipoprotein B (apoB), and lipoprotein(a) [Lp(a)] were investigated. When all patients were considered together (Table 1), EE2 therapy significantly increased serum levels of total cholesterol, HDL cholesterol and LDL cholesterol. The ratio of HDL to LDL cholesterol, Lp(a) and triglyceride concentrations did not change significantly from the baseline value. Although our study was not randomized or controlled with a placebo, the beneficial metabolic effects of ethinyl-estradiol on lipid patterns should be considered in patients needing hormonal replacement therapy in postmenopause.",2001,"The ratio of HDL to LDL cholesterol, Lp(a) and triglyceride concentrations did not change significantly from the baseline value.","['postmenopausal women', 'patients needing hormonal replacement therapy in postmenopause', '5.0 years) who underwent a hysterectomy and bilateral salpingo-oophorectomy were included in the study', 'One hundred and five patients (mean age [+/-S D] 42.9 ']","['placebo', 'ethinyl-estradiol']","['total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, apolipoprotein B (apoB), and lipoprotein(a) [Lp(a', 'serum levels of total cholesterol, HDL cholesterol and LDL cholesterol', 'lipid profile', 'ratio of HDL to LDL cholesterol, Lp(a) and triglyceride concentrations']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0206159', 'cui_str': 'Post-menopausal Period'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517773', 'cui_str': 'Forty-two point nine'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",105.0,0.110545,"The ratio of HDL to LDL cholesterol, Lp(a) and triglyceride concentrations did not change significantly from the baseline value.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Minozzi', 'Affiliation': 'II Institute of Obstetrics and Gynecology, University of Rome La Sapienza, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Costabile', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cosmi', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Donadio', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'De Filippis', 'Affiliation': ''}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Cosmi', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1155,31949092,Effect of a formulated eye drop with  Leptospermum  spp honey on tear film properties.,"AIM


To evaluate the effects of a proprietary formulated eye drop with  Leptospermum  spp honey versus a conventional lubricant eye drop on tear film properties in subjects with symptoms related to dry eye disease after 28 days of treatment.
METHODS


Forty-six subjects with symptoms related to dry eye (Ocular Surface Disease Index (OSDI) score >12) were enrolled and randomly assigned to receive either the test formulated eye drop (Optimel by Melcare Biomedical Pty Ltd) or control eye drops (Alcon, USA) in this double-masked study. Inferior lipid layer thickness (LLT), tear film evaporation rate (TER), fluorescein tear film break-up time (TBUT), corneal staining and subjective symptoms (OSDI and visual analogue scales (VAS)) were measured before and after 28 days of instilling the eye drops.
RESULTS


Forty-two subjects completed the study (21 subjects in each group). After 28 days of treatment, TER showed a significantly greater reduction with the formulated eye drop compared with the control (p=0.01). TBUT showed a slight but not statistically significant increase with the formulated eye drop compared with the control (p=0.06), and a significantly greater reduction (improvement) in OSDI scores was observed with the formulated eye drop compared with the control (p=0.01). No significant differences were found between the two groups for inferior LLT, corneal staining and any of the VAS scores.
CONCLUSIONS


The formulated eye drops were effective in reducing tear film evaporation rate and were more effective for improving symptoms of dry eye compared with the control eye drops after 28 days of treatment.
TRIAL REGISTRATION NUMBER


NCT03622619.",2020,"The formulated eye drops were effective in reducing tear film evaporation rate and were more effective for improving symptoms of dry eye compared with the control eye drops after 28 days of treatment.
","['Forty-six subjects with symptoms related to dry eye (Ocular Surface Disease Index (OSDI) score >12', 'Forty-two subjects completed the study (21 subjects in each group', 'subjects with symptoms related to dry eye disease after 28 days of treatment']","['test formulated eye drop (Optimel by Melcare Biomedical Pty Ltd) or control eye drops (Alcon, USA', 'TER', 'proprietary formulated eye drop with  Leptospermum  spp honey versus a conventional lubricant eye drop']","['Inferior lipid layer thickness (LLT), tear film evaporation rate (TER), fluorescein tear film break-up time (TBUT), corneal staining and subjective symptoms (OSDI and visual analogue scales (VAS', 'inferior LLT, corneal staining and any of the VAS scores', 'OSDI scores', 'tear film evaporation rate']","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1049351', 'cui_str': 'New Zealand Manuka'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2608262', 'cui_str': 'Lubricating Eye Drops'}]","[{'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time (observable entity)'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",46.0,0.0609643,"The formulated eye drops were effective in reducing tear film evaporation rate and were more effective for improving symptoms of dry eye compared with the control eye drops after 28 days of treatment.
","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia jacqueline.tan@unsw.edu.au.'}, {'ForeName': 'Tianni', 'Initials': 'T', 'LastName': 'Jia', 'Affiliation': 'School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Liao', 'Affiliation': 'School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stapleton', 'Affiliation': 'School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-315160']
1156,31175096,Health-Related Quality of Life Impact from Adding Bevacizumab to Cisplatin-Pemetrexed in Malignant Pleural Mesothelioma in the MAPS IFCT-GFPC-0701 Phase III Trial.,"PURPOSE


The IFCT-GFPC-0701 MAPS phase III trial highlighted significant improvement in overall survival from adding bevacizumab to the standard first-line chemotherapy regimen [cisplatin plus pemetrexed (PC)] in advanced malignant pleural mesothelioma (MPM). We present the results of health-related quality of life (HRQoL), a secondary endpoint of MAPS.
PATIENTS AND METHODS


HRQoL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 and the lung cancer-specific module QLQ-LC13 at randomization and then every 9 weeks until disease progression.HRQoL deterioration-free survival (QFS), used to analyze longitudinal HRQoL data, was defined as the interval between randomization and the occurrence of the first clinically relevant definitive deterioration compared with the HRQoL score at baseline, or death.
RESULTS


A total of 448 patients were included in the MAPS trial between 2008 and 2014. At baseline, 425 patients (94.8%) completed the HRQoL questionnaire. We report that adding bevacizumab to cisplatin and pemetrexed (PCB) significantly improved QFS for the peripheral neuropathy dimension, with a median QFS of 12.09 months [95% confidence interval (CI), 9.59-13.67] in the PCB arm versus 7.59 months (95% CI, 6.57-8.61) in the PC arm [HR (PCB vs. PC) = 0.74; 95% CI, 0.61-0.91;  P  = 0.004]. QFS was also longer in the PCB arm for the pain dimension (HR = 0.84; 95% CI, 0.69-1.02;  P  = 0.08).
CONCLUSIONS


This study demonstrated that adding bevacizumab to standard chemotherapy in patients with advanced MPM had no negative impact on HRQoL. A significant improvement in the peripheral neuropathy and pain HRQoL dimensions was even observed.",2019,"QFS was also longer in the PCB arm for the pain dimension (HR=0.84, 95% CI 0.69-1.02; p=0.08).","['advanced malignant pleural mesothelioma (MPM', 'patients with advanced MPM', 'A total of 448 patients were included in the MAPS trial between 2008 and 2014']","['Bevacizumab to Cisplatin-Pemetrexed', 'bevacizumab', 'chemotherapy regimen (cisplatin plus pemetrexed (PC', 'bevacizumab to cisplatin and pemetrexed (PCB']","['Cancer (EORTC', 'HRQoL questionnaire', 'HRQoL deterioration-free survival (QFS', 'peripheral neuropathy and pain HRQoL dimensions', 'health-related quality of life (HRQoL', 'pain dimension', 'QFS', 'Quality of Life Questionnaire QLQ-C30 and the Lung Cancer specific module QLQ-LC13', 'overall survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura (disorder)'}, {'cui': 'C1742123', 'cui_str': '(11C)MPM'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032447', 'cui_str': 'PCBs'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",448.0,0.198596,"QFS was also longer in the PCB arm for the pain dimension (HR=0.84, 95% CI 0.69-1.02; p=0.08).","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Eberst', 'Affiliation': 'Chest Disease Department, University Hospital, Besançon, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'Methodology and Quality of Life in Oncology Unit, University Hospital, Besançon, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Scherpereel', 'Affiliation': 'Pulmonary and Thoracic Oncology Department, University Hospital, Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Department of Pulmonology, Larrey Hospital, Toulouse, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Margery', 'Affiliation': 'Gustave Roussy Institute, Villejuif, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Greillier', 'Affiliation': 'Multidisciplinary Oncology and Therapeutic Innovations Department, Assistance Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Department of Pulmonology, Centre Hospitalier Intercommunal, Toulon, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Pôle Thorax and Vaisseaux, Centre Hospitalier Universitaire, Grenoble, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Department of Pulmonology, Centre Hospitalier, Le Mans, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Léna', 'Affiliation': 'Department of Pulmonology, University Hospital, Rennes, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Rivière', 'Affiliation': ""Department of Pulmonology, Hôpital d'instruction des armées Percy, Clamart, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Monnet', 'Affiliation': 'Department of Pulmonology, Centre Hospitalier Intercommunal Créteil, Créteil, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Gounant', 'Affiliation': 'Hôpital Tenon, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Janicot', 'Affiliation': 'Department of Pulmonology, Gabriel-Montpied University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Radj', 'Initials': 'R', 'LastName': 'Gervais', 'Affiliation': 'Centre régional de lutte contre le cancer François Baclesse, Caen, France.'}, {'ForeName': 'Chrystelle', 'Initials': 'C', 'LastName': 'Locher', 'Affiliation': 'Department of Pulmonology, Centre Hospitalier, Meaux, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Charton', 'Affiliation': 'Methodology and Quality of Life in Oncology Unit, University Hospital, Besançon, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'French Cooperative Thoracic Group (IFCT), Paris, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Zalcman', 'Affiliation': ""Department of Thoracic Oncology, Centre d'investigation clinique Institut national de la santé et de la recherche médicale 1425, Hospital Bichat-Claude Bernard, Assistance Publique-Hôpitaux de Paris, Paris-Diderot University (Paris 7), Paris, France.""}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Westeel', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2860']
1157,10968345,"Cetrotide confirmatory trial of cetrorelix/0.25 mg in 26 women undergoing ovarian stimulation with recombinant follicle stimulating hormones for IVF, ICSI and embryo transfer (ET).","BACKGROUND


There have been numerous double-blind, randomised, dose-finding studies of the gonadotrophin-releasing hormone (Gn-RH) antagonist Ganirelix (Org 37462) and the Gn-RH antagonist Cetrorelix.
METHODS


We performed a clinical trial with 26 patients undergoing ovarian stimulation with the recombinant human follicle stimulating hormone (FSH) by applying rec. FSH in a flexible daily dose, depending on the estradiol levels of the patient, from day 3 of the cycle onwards in a controlled ovarian hyperstimulation (COH) protocol. A single dose of 0.25 mg was injected daily subcutaneously from day 7 of the cycle onwards until the day of HCG application. The recombinant FSH dose was adjusted according to ovarian response. Fifteen patients were treated for IVF and nine for ICSI. In two patients egg retrieval was not performed. Estradiol and LH levels were measured on the day of HCG application.
RESULTS


The mean number of recovered oocytes in the 24 patients was 5.5. A fertilisation rate of 64% was achieved in the IVF group and 69% in the ICSI group. In Germany a maximum of three embryos per patient is permitted to be transferred. Pregnancy occurred in ten patients: 5 IVF patients and 5 ICSI patients. In this small group of IVF patients a 33% pregnancy rate per follicular puncture and a 50% pregnancy rate per embryo transfer resulted. The ICSI group showed a 55% pregnancy rate per follicular puncture and a 62% pregnancy rate per embryo transfer.
CONCLUSION


Within an IVF/ET, ICSI programme the Gn-RH-antagonist Cetrorelix in combination with rec. FSH gave optimal pregnancy results.",2000,A fertilisation rate of 64% was achieved in the IVF group and 69% in the ICSI group.,"['26 patients undergoing ovarian stimulation with the recombinant human follicle stimulating hormone (FSH) by applying rec', '26 women undergoing ovarian stimulation with recombinant follicle stimulating hormones for IVF, ICSI and embryo transfer (ET', 'Fifteen patients were treated for IVF and nine for ICSI']","['IVF/ET', 'FSH', 'cetrorelix/0.25', 'recombinant FSH', 'ICSI', 'gonadotrophin-releasing hormone (Gn-RH) antagonist Ganirelix']","['pregnancy rate per follicular puncture', 'Estradiol and LH levels', 'fertilisation rate', 'mean number of recovered oocytes', 'Pregnancy', 'pregnancy rate per embryo transfer']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0016774', 'cui_str': 'Follicle Stimulating Hormone, Human'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0073629', 'cui_str': 'ganirelix'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]",26.0,0.497257,A fertilisation rate of 64% was achieved in the IVF group and 69% in the ICSI group.,"[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mettler', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Kiel, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Brandenburg', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1158,10968358,Uterine malformations and pregnancy losses: is cervical cerclage effective?,"For many years, we and others have reported the efficacy of cervical cerclage in the prevention of miscarriage in patients with uterine malformations. In this paper the experience of 275 cases collected between 1978 and 1998 is reported. Our data indicate that cervical cerclage is effective in preventing miscarriages, prevalently in those pregnancies bearing uterine malformations with simultaneous cervical incompetence.",2000,"Our data indicate that cervical cerclage is effective in preventing miscarriages, prevalently in those pregnancies bearing uterine malformations with simultaneous cervical incompetence.",['patients with uterine malformations'],['cervical cerclage'],['Uterine malformations and pregnancy losses'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243070', 'cui_str': 'malformations'}]","[{'cui': 'C3853999', 'cui_str': 'Cervical cerclage (physical object)'}]","[{'cui': 'C0243070', 'cui_str': 'malformations'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}]",,0.0180473,"Our data indicate that cervical cerclage is effective in preventing miscarriages, prevalently in those pregnancies bearing uterine malformations with simultaneous cervical incompetence.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Surico', 'Affiliation': 'Clinics of Obstetrics and Gynecology, Dept. of Medical Sciences, University of Eastern Piedmont and Maggiore Hospital, Novara, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ribaldone', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arnulfo', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Baj', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1159,31462735,MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial.,"We report assessment of minimal residual disease (MRD) status and its association with outcome in rituximab-refractory follicular lymphoma (FL) in the randomized GADOLIN trial (NCT01059630). Patients received obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone. Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement) detected at study screening were assessed for MRD at mid-induction (MI), end of induction (EOI), and every 6-24 months post-EOI/discontinuation by real-time quantitative PCR. At MI, 41/52 (79%) patients receiving G-Benda were MRD-negative vs. 17/36 (47%) patients receiving Benda alone (p = 0.0029). At EOI, 54/63 (86%) patients receiving G-Benda were MRD-negative vs. 30/55 (55%) receiving Benda alone (p = 0.0002). MRD-negative patients at EOI had improved progression-free survival (HR, 0.33, 95% CI, 0.19-0.56, p < 0.0001) and overall survival (HR, 0.39, 95% CI, 0.19-0.78, p = 0.008) vs. MRD-positive patients, and maintained their MRD-negative status for longer if they received G maintenance than if they did not. These results suggest that the addition of G to Benda-based treatment during induction can significantly contribute to the speed and depth of response, and G maintenance in MRD-negative patients potentially delays lymphoma regrowth.",2020,patients receiving Benda alone (p = 0.0029).,"['rituximab-refractory follicular lymphoma (FL', 'Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement']","['obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone', 'bendamustine']","['MRD response', 'progression-free survival', 'overall survival']","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0473059,patients receiving Benda alone (p = 0.0029).,"[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany. c.pott@med2.uni-kiel.de.'}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'British Columbia Cancer Agency and the University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Department of Internal Medicine-Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gribben', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Hospital of the Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Kehden', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Nicolas-Virelizier', 'Affiliation': 'University of Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Spielewoy', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Harbron', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Mundt', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Wassner-Fritsch', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Georgetown University Hospital, Washington, DC, USA.'}]",Leukemia,['10.1038/s41375-019-0559-9']
1160,31947040,The Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Balance Control in Children with Cerebral Palsy.,"Cerebral palsy (CP) is a neurological disorder which can result in balance and mobility impairments. Four children with spastic CP participated and randomly assigned to experimental and control groups. The experimental group received 1-Hz repetitive Transcranial Magnetic Stimulation (rTMS) four times a week for 3 weeks, and the control group received sham rTMS using the similar experimental protocol. Each rTMS session lasted for 20 minutes. Postural balance was quantified by analyzing the center of pressure (COP) signal of a force plate according to the Romberg test. The balance was also evaluated using the Berg Balance Scale (BBS). The evaluations were done before and after the treatment. COP signal features showed up to 70% improvement following rTMS treatment, whereas there was no notable improvements in the control group. Similarly the BBS assessment presented balance enhancement only in the experimental group. These results, particularly under closed eye foam condition may imply an improvement in proprioception system.Our findings suggested that rTMS has a potential to be used as a therapeutic method to improve postural balance in children with CP.",2019,"COP signal features showed up to 70% improvement following rTMS treatment, whereas there was no notable improvements in the control group.","['Children with Cerebral Palsy', 'Four children with spastic CP', 'children with CP']","['rTMS', 'Repetitive Transcranial Magnetic Stimulation (rTMS', 'control group received sham rTMS', '1-Hz repetitive Transcranial Magnetic Stimulation (rTMS']","['COP signal features', 'Berg Balance Scale (BBS', 'balance enhancement', 'postural balance', 'proprioception system', 'Postural balance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",,0.0100454,"COP signal features showed up to 70% improvement following rTMS treatment, whereas there was no notable improvements in the control group.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dadashi', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shahroki', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nourian', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Irani', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Molavi', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Rafieenazari', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2019.8857361']
1161,11332584,Ultrastructural aspects of the postmenopausal endometrium after oral or transdermal estrogen administration.,"In this report we examined the ultrastructural features of the postmenopausal endometrial cells of women treated with different doses of conjugated equine estrogen (CEE), or transdermal 17beta-estradiol. Eight women with uterine prolapse and at least 5 years of menopause were randomly divided into four groups and treated as follows: (I) no hormonal treatment; (II) 0.625mg/day of CEE orally; (III) 1.25mg/day of CEE orally; (IV) 50microg/day of 17beta-estradiol transdermally. Hormones were administered for 28 days followed by vaginal hysterectomy. Fragments of the endometrium were prepared for transmission electron microscopic analysis. We observed that the postmenopausal endometrium of the untreated group was atrophic with lined superficial epithelial cuboidal cells. The presence of gland and stroma cells with clear cytoplasm containing few organelles and heterochromatin nuclei were also observed. On the contrary, the endometrium of the group that received 0.625mg/day of CEE showed signs of proliferative cells such as the presence of numerous organelles in the cytoplasm and euchromatic nuclei. All of the proliferative effects on the endometrium were more pronounced in the groups that received 1.25mg/day of CEE and 50microg/day of transdermal 17beta-estradiol. We concluded that the ultrastructural proliferative changes of the postmenopausal endometrium induced by 1.25mg/day of CEE were similar to 50microg/day of transdermal 17beta-estradiol.",2001,All of the proliferative effects on the endometrium were more pronounced in the groups that received 1.25mg/day of CEE and 50microg/day of transdermal 17beta-estradiol.,['Eight women with uterine prolapse and at least 5 years of menopause'],"['conjugated equine estrogen (CEE), or transdermal 17beta-estradiol']",['ultrastructural proliferative changes of the postmenopausal endometrium'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042140', 'cui_str': 'Uterine Prolapse'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}]","[{'cui': 'C1136013', 'cui_str': 'Conjugated Equine Estrogens'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2112532', 'cui_str': 'Senile endometrium'}]",8.0,0.0347472,All of the proliferative effects on the endometrium were more pronounced in the groups that received 1.25mg/day of CEE and 50microg/day of transdermal 17beta-estradiol.,"[{'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Baracat', 'Affiliation': 'Department of Gynecology, Federal University of São Paulo, Paulista Medical School, Brazil.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Simões', 'Affiliation': ''}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Soares', 'Affiliation': ''}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Haidar', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rodrigues de Lima', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1162,30930211,Effect of Low-pressure Pulmonary Recruitment Maneuver on Postlaparoscopic Shoulder Pain: Randomized Controlled Trial.,"STUDY OBJECTIVE


Postlaparoscopic shoulder pain (PLSP) is effectively reduced by a pulmonary recruitment maneuver (PRM). The goal of this study is to assess the efficacy of a PRM using maximal inspiratory pressure of 30 cm H 2 O, which is lower than previously studied pressure for reducing PLSP.
DESIGN


Randomized controlled trial.
SETTING


University hospital.
PATIENTS


Eighty-four patients who were undergoing elective gynecologic laparoscopy.
INTERVENTIONS


Patients were randomly assigned to the control (n = 42) or the PRM (n = 42) group.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was the intensity of the shoulder pain using the visual analog scale (VAS). The VAS score of shoulder pain (median [interquartile range]) was significantly lower in the PRM group than in the control group at 24 hours (0 [0-0] vs 1.5 [0-4.0], p <.001) and 48 hours (0 [0-0] vs 1.0 [0-2.0], p <.001) after surgery. Other variables, including surgical pain score and vital signs, were similar between the 2 groups.
CONCLUSION


The PRM with 30 cm H 2 O can be a simple method to reduce PLSP. Therefore, it would be helpful to perform the PRM with 30 cm H 2 O routinely.",2020,The VAS score of shoulder pain (median [interquartile range]) was significantly lower in the PRM group than in the control group at 24 hours (0,"['Eighty-four patients who were undergoing elective gynecologic laparoscopy', 'University hospital', 'Postlaparoscopic shoulder pain (PLSP']","['PRM', 'Low-pressure Pulmonary Recruitment Maneuver']","['intensity of the shoulder pain using the visual analog scale (VAS', 'Postlaparoscopic Shoulder Pain', 'surgical pain score and vital signs', 'VAS score of shoulder pain']","[{'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0518766'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",84.0,0.137009,The VAS score of shoulder pain (median [interquartile range]) was significantly lower in the PRM group than in the control group at 24 hours (0,"[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Departments of Anesthesiology and Pain Medicine (Drs. Lee, Park, J. Kim, and Ki).'}, {'ForeName': 'Chunghyun', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Departments of Anesthesiology and Pain Medicine (Drs. Lee, Park, J. Kim, and Ki).'}, {'ForeName': 'Jihee', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Departments of Anesthesiology and Pain Medicine (Drs. Lee, Park, J. Kim, and Ki).'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Ki', 'Affiliation': 'Departments of Anesthesiology and Pain Medicine (Drs. Lee, Park, J. Kim, and Ki).'}, {'ForeName': 'Sun Hee', 'Initials': 'SH', 'LastName': 'Cha', 'Affiliation': 'Obstetrics and Gynecology (Dr. Cha), CHA Bundang Medical Center, CHA University, Seongnam, Korea.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine (Dr. J. Y. Kim), Ajou University School of Medicine, Suwon, Korea.. Electronic address: kjyeop@ajou.ac.kr.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.03.020']
1163,10758799,Renin-aldosterone system alterations during abdominal gynaecological operations under general or combined general and epidural anaesthesia.,"Alterations of plasma renin-activity and aldosterone levels were comparatively studied in 41 premenopausal patients who were subjected to total abdominal hysterectomy. Twenty-one women received general anaesthesia (group A) and 20 received a combination of general and epidural anaesthesia (group B). Five blood specimens were drawn from each patient in order to determine plasma aldosterone levels (PA) and plasma renin activity (PRA) by radioimmunoassay (RIA). The rise of PA levels in group A occurred 30 min after the initiation of surgery and at that time there was a statistically significant difference as compared with the epidural anaesthesia (EA) group (p < 0.001). PRA levels in both groups showed a rise of limited statistical significance at 30 minutes after the initiation of surgery (p < 0.05). During the remaining time intervals, group A did not show any significant changes, whereas group B showed a reduction of limited statistical significance (p < 0.05). General anaesthesia for gynecological abdominal surgery without the use of volatile agents significantly increases plasma aldosterone levels. Combined anaesthesia does not totally inhibit intraoperative hyperaldosteroism but it is much slower and is of great advantage for the patient.",2000,"During the remaining time intervals, group A did not show any significant changes, whereas group B showed a reduction of limited statistical significance (p < 0.05).","['abdominal gynaecological operations under general or combined general and epidural anaesthesia', '41 premenopausal patients who were subjected to total abdominal hysterectomy']","['general anaesthesia', 'combination of general and epidural anaesthesia', 'epidural anaesthesia (EA']","['plasma aldosterone levels', 'PRA levels', 'plasma aldosterone levels (PA) and plasma renin activity (PRA) by radioimmunoassay (RIA', 'rise of PA levels', 'plasma renin-activity and aldosterone levels']","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0404079', 'cui_str': 'Total abdominal hysterectomy (procedure)'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C1272143', 'cui_str': 'Plasma aldosterone level'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034580', 'cui_str': 'Radioimmunoassay'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}]",41.0,0.0248757,"During the remaining time intervals, group A did not show any significant changes, whereas group B showed a reduction of limited statistical significance (p < 0.05).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Petropoulos', 'Affiliation': 'Second Department of Obstetrics and Gynecology, Aretaieion Hospital, University of Athens, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vadalouca', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Siafaka', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sykiotis', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Loghis', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Salamalekis', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1164,31394106,Beneficial effect of personalized lifestyle advice compared to generic advice on wellbeing among Dutch seniors - An explorative study.,"The aim of this explorative study is to evaluate whether personalized compared to generic lifestyle advice improves wellbeing in a senior population. We conducted a nine-week single-blind randomized controlled trial including 59 participants (age 67.7 ± 4.8 years) from Wageningen and its surrounding areas in the Netherlands. Three times during the intervention period, participants received either personalized advice (PA), or generic advice (GA) to improve lifestyle behavior. Personalization was based on metabolic health measures and dietary intake resulting in an advice that highlighted food groups and physical activity types for which behavior change was most urgent. Before and after the intervention period self-perceived health was evaluated as parameter of wellbeing using a self-perceived health score (single-item) and two questionnaires (Vita-16 and Short Form-12). Additionally, anthropometry and physical functioning (short physical performance battery, SPPB) were assessed. Overall scores for self-perceived health did not change over time in any group. Resilience and motivation (Vita-16) slightly improved only in the PA group, whilst mental health (SF-12) and energy (Vita-16) showed slight improvement only in the GA group. SPPB scores improved over time in both the PA and GA group. PA participants also showed a reduction in body fat percentage and hip circumference, whereas these parameters increased in the GA group Our findings suggest that although no clear effects on wellbeing were found, still, at least on the short term, personalized advice may evoke health benefits in a population of seniors as compared to generic advice.",2019,Overall scores for self-perceived health did not change over time in any group.,"['Dutch seniors - An explorative study', 'senior population', '59 participants (age 67.7\u202f±\u202f4.8\u202fyears) from Wageningen and its surrounding areas in the Netherlands']","['personalized advice (PA), or generic advice (GA', 'personalized lifestyle advice', 'generic advice', 'generic lifestyle advice']","['mental health (SF-12) and energy (Vita-16', 'Resilience and motivation', 'SPPB scores', 'body fat percentage and hip circumference', 'anthropometry and physical functioning (short physical performance battery, SPPB']","[{'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}]",59.0,0.0197099,Overall scores for self-perceived health did not change over time in any group.,"[{'ForeName': 'Esmée L', 'Initials': 'EL', 'LastName': 'Doets', 'Affiliation': 'Wageningen University & Research, Wageningen Food & Biobased Research, Wageningen, the Netherlands.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'de Hoogh', 'Affiliation': 'TNO Innovation for Life, Den Haag, the Netherlands. Electronic address: iris.dehoogh@tno.nl.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Holthuysen', 'Affiliation': 'Wageningen University & Research, Wageningen Food & Biobased Research, Wageningen, the Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Wopereis', 'Affiliation': 'TNO Innovation for Life, Den Haag, the Netherlands.'}, {'ForeName': 'Muriel C D', 'Initials': 'MCD', 'LastName': 'Verain', 'Affiliation': 'Wageningen University & Research, Wageningen Economic Research, Den Haag, the Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'van den Puttelaar', 'Affiliation': 'Wageningen University & Research, Wageningen Economic Research, Den Haag, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Hogenelst', 'Affiliation': 'TNO Innovation for Life, Den Haag, the Netherlands.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Boorsma', 'Affiliation': 'TNO Innovation for Life, Den Haag, the Netherlands.'}, {'ForeName': 'Emily P', 'Initials': 'EP', 'LastName': 'Bouwman', 'Affiliation': 'Wageningen University & Research, Wageningen Economic Research, Den Haag, the Netherlands.'}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Timmer', 'Affiliation': 'Wageningen University & Research, Wageningen Food & Biobased Research, Wageningen, the Netherlands.'}, {'ForeName': 'Wilrike J', 'Initials': 'WJ', 'LastName': 'Pasman', 'Affiliation': 'TNO Innovation for Life, Den Haag, the Netherlands.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'van Erk', 'Affiliation': 'TNO Innovation for Life, Den Haag, the Netherlands.'}, {'ForeName': 'Machiel J', 'Initials': 'MJ', 'LastName': 'Reinders', 'Affiliation': 'Wageningen University & Research, Wageningen Economic Research, Den Haag, the Netherlands.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112642']
1165,31888736,Motor intervention with and without Nintendo® Wii for children with developmental coordination disorder: protocol for a randomized clinical trial.,"BACKGROUND


Despite the benefits highlighted by motor interventions based on virtual reality for children with Developmental Coordination Disorder (DCD), there are still doubts as to whether these are greater than those obtained with conventional interventions due to the absence of systematized protocols, and lack of evidence. Here, we present a protocol to systematically compare the effects of two motor-training programs (one Nintendo® Wii-based and the other no-Wii motor activities) on the motor learning in children with DCD.
METHODS/DESIGN


Two intervention protocols (one based on Nintendo® Wii and the other no-Wii motor activities) will be carried out, with interventions occurring twice a week in 60-min sessions, with a minimum of 12 and a maximum of 16 sessions per child. The protocols were developed based on the domains of the Movement Assessment Battery for Children - Second Edition (MABC-2) (Manual Dexterity, Aiming and Catching, Balance), with two activities for each of the MABC - two domains. The study will include children aged 7 to 10 years with a total MABC-2 score ≤ 16, and a Developmental Coordination Disorder Questionnaire (DCDQ) score < 46 (age of 7 years), score < 55 (age group of 8 to 9 years and 11 months), or score < 57 (age of 10 years) as scored by the parents. Children will be randomly allocated by draw in one of the two intervention protocols. MABC-2 and DCDQ will be applied before and after intervention to evaluate the effects of the interventions on motor performance and parents' perception, respectively. Motor learning will be assessed by means of the scores obtained in the games. Evaluators and therapists will be trained and evaluators will be blind regarding the data of the children in the study.
DISCUSSION


Owing to its motivating aspects, training with Nintendo® Wii may be particularly beneficial for children with DCD. The results of this study protocol should help researchers and therapists to better understand the benefits of Nintendo® Wii-based motor intervention over those obtained with no-Wii interventions in children with DCD. It should also create references about more systematized protocols for replication in clinical practice, seeking the improvement of the motor components of these children.
TRIAL REGISTRATION


RBR-89ydgj.",2019,"The protocols were developed based on the domains of the Movement Assessment Battery for Children - Second Edition (MABC-2) (Manual Dexterity, Aiming and Catching, Balance), with two activities for each of the MABC - two domains.","['children with DCD', 'children with Developmental Coordination Disorder (DCD', 'children aged 7 to 10 years with a total MABC-2 score\u2009≤\u200916, and a Developmental Coordination Disorder Questionnaire (DCDQ) score\u2009<\u200946 (age of 7\u2009years), score\u2009<\u200955 (age group of 8 to 9\u2009years and 11\u2009months), or score\u2009<\u200957 (age of 10\u2009years) as scored by the parents', 'children with developmental coordination disorder']","['Nintendo® Wii and the other no-Wii motor activities', 'motor-training programs (one Nintendo® Wii-based and the other no-Wii motor activities', 'Motor intervention with and without Nintendo® Wii', 'Nintendo® Wii-based motor intervention']",['Motor learning'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0608070', 'cui_str': 'dicarboxydine'}, {'cui': 'C0011757', 'cui_str': 'Developmental Coordination Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.0372228,"The protocols were developed based on the domains of the Movement Assessment Battery for Children - Second Edition (MABC-2) (Manual Dexterity, Aiming and Catching, Balance), with two activities for each of the MABC - two domains.","[{'ForeName': 'Jorge Lopes', 'Initials': 'JL', 'LastName': 'Cavalcante Neto', 'Affiliation': 'Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Steenbergen', 'Affiliation': 'Radboud University, Nijmegen, The Netherlands. b.steenbergen@pwo.ru.nl.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Tudella', 'Affiliation': 'Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}]",Trials,['10.1186/s13063-019-3930-2']
1166,31888738,Effects of acupuncture on the hypothalamus-pituitary-adrenal axis in chronic insomnia patients: a study protocol for a randomized controlled trial.,"BACKGROUND


Acupuncture, as an important component of traditional Chinese medicine (TCM), has been widely applied in the treatment of chronic insomnia in China, while there is no clinical study related to its therapeutic mechanism.
METHODS/DESIGN


A single-center, single-blind, randomized, placebo-controlled trial will be conducted at Jiangsu Hospital of Traditional Chinese Medicine. A total of 60 patients will be registered. Eligible participants will be randomly divided into acupuncture group and sham acupuncture group (n = 30 cases in each group). Patients in both groups will be treated once every other day, three times per week for 4 weeks. The primary outcome measures are Pittsburgh Sleep Quality Index (PSQI) and concentrations of adrenocorticotropic hormone (ATCH), corticotrophin-releasing hormone (CRH), and cortisol (CORT). Secondary outcome measures are Insomnia Severity Index (ISI) and Fatigue Severity Scale (FSS).
DISCUSSION


This study aims to evaluate the therapeutic effects of acupuncture on chronic insomnia by using PSQI, ISI, and FSS. The mechanism of acupuncture on CIPs will be preliminarily discussed by analyzing the changes in concentrations of CRH, ACTH, and CORT before and after treatment.
TRIAL REGISTRATION


Chinese Clinical Trials Register, ChiCTR1800020298.",2019,"Secondary outcome measures are Insomnia Severity Index (ISI) and Fatigue Severity Scale (FSS).
","['chronic insomnia patients', '60 patients will be registered', 'Eligible participants', 'Jiangsu Hospital of Traditional Chinese Medicine', 'A single-center']","['placebo', 'traditional Chinese medicine (TCM', 'acupuncture group and sham acupuncture', 'acupuncture']","['Insomnia Severity Index (ISI) and Fatigue Severity Scale (FSS', 'chronic insomnia', 'concentrations of CRH, ACTH, and CORT', 'Pittsburgh Sleep Quality Index (PSQI) and concentrations of adrenocorticotropic hormone (ATCH), corticotrophin-releasing hormone (CRH), and cortisol (CORT']","[{'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201835', 'cui_str': 'Adrenocorticotropic hormone measurement (procedure)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",60.0,0.183553,"Secondary outcome measures are Insomnia Severity Index (ISI) and Fatigue Severity Scale (FSS).
","[{'ForeName': 'Chengyong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Shiyu', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Wenzhong', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China. maerta_zhongacu@163.com.'}, {'ForeName': 'Xiaoqiu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hanqing', 'Initials': 'H', 'LastName': 'Xi', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qingyun', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.'}]",Trials,['10.1186/s13063-019-3964-5']
1167,31888729,Prospective randomized controlled trial comparing the efficacy and safety of Roux-en-Y gastric bypass and one-anastomosis gastric bypass (the RYSA trial): trial protocol and interim analysis.,"INTRODUCTION


There is a lack of prospective studies comparing Roux-en-Y gastric bypass (RYGB) and one-anastomosis gastric bypass (OAGB). Also, the effects of bariatric surgery and weight loss need a deeper understanding through metabolic studies. We describe the trial protocol and interim analysis of a prospective randomized controlled study comparing RYGB and OAGB: the RYSA trial.
MATERIALS AND METHODS


In total, 120 bariatric patients will be randomized between RYGB and OAGB in two academic centers. All patients will be followed up for 10 years with analysis and measurements of weight, comorbidities, blood tests, body composition and questionnaires. Extensive metabolic analyses (mixed meal tests, energy expenditure, biopsies of muscle and subcutaneous fat, urine, saliva and fecal samples) will be carried out in the Obesity Research Unit, University of Helsinki, for all patients treated at the Helsinki University Hospital (80 patients) at baseline, 6 months and 12 months. Bile reflux will be studied for the OAGB group at the Helsinki University Hospital at 6 months with gastroscopy and scintigraphy.
RESULTS


At an interim analysis at 3 months (half-way) through recruitment (30 RYGB and 30 OAGB patients) there have been no deaths and no intensive care unit admittances. One patient in both groups required additional gastroscopy, with anastomosis dilatation in the RYGB group but with no additional intervention in the OAGB group.
CONCLUSION


The trial can be safely carried out. Recruitment is estimated to be complete by the end of 2019.
TRIAL REGISTRATION


Clinical Trials Identifier NCT02882685. Registered on August 30th 2016.",2019,"One patient in both groups required additional gastroscopy, with anastomosis dilatation in the RYGB group but with no additional intervention in the OAGB group.
",['120 bariatric patients'],"['RYGB and OAGB', 'Roux-en-Y gastric bypass and one-anastomosis gastric bypass', 'Roux-en-Y gastric bypass (RYGB) and one-anastomosis gastric bypass (OAGB']","['weight, comorbidities, blood tests, body composition and questionnaires', 'Extensive metabolic analyses (mixed meal tests, energy expenditure, biopsies of muscle and subcutaneous fat, urine, saliva and fecal samples', 'efficacy and safety', 'Bile reflux']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0017125', 'cui_str': 'Gastric Bypass'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle (procedure)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0042037'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005403', 'cui_str': 'Bile Reflux'}]",120.0,0.0565136,"One patient in both groups required additional gastroscopy, with anastomosis dilatation in the RYGB group but with no additional intervention in the OAGB group.
","[{'ForeName': 'Tuure', 'Initials': 'T', 'LastName': 'Saarinen', 'Affiliation': 'Department of Gastrointestinal Surgery, Helsinki University Hospital, Abdominal Center, Haartmaninkatu 4, 00029 HUS, Helsinki, Finland. tuure.saarinen@hus.fi.'}, {'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Meriläinen', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Vesa', 'Initials': 'V', 'LastName': 'Koivukangas', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Kirsi Hannele', 'Initials': 'KH', 'LastName': 'Pietiläinen', 'Affiliation': 'Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Juuti', 'Affiliation': 'Department of Gastrointestinal Surgery, Helsinki University Hospital, Abdominal Center, Haartmaninkatu 4, 00029 HUS, Helsinki, Finland.'}]",Trials,['10.1186/s13063-019-3898-y']
1168,31888740,"Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): study protocol for a randomized, controlled, multicenter, international clinical trial.","BACKGROUND


Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenously administered lipid emulsions (ILEs) are an essential component of HPN, providing energy and essential fatty acids, but can become a risk factor for intestinal-failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited.
METHODS/DESIGN


The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA-enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem/Lipoplus® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin® MCT/LCT/Medialipide® 20%, B. Braun Melsungen AG) for a projected period of 8 weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of the safety and tolerability as well as the efficacy of the ILEs.
DISCUSSION


Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The working hypothesis is that n-3 PUFA-enriched ILE is safe and well-tolerated especially with regard to liver function in patients requiring HPN. The expected outcome is to provide reliable data to support this thesis thanks to a considerable number of CIF patients, consequently to broaden the present evidence on the use of ILEs in HPN.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT03282955. Registered on 14 September 2017.",2019,"The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit.","['160 patients (80 per group', 'patients with chronic intestinal failure (the HOME study', 'patients with chronic intestinal failure (CIF', 'patients requiring HPN', 'European hospitals that treat HPN patients']","['omega-3 polyunsaturated fatty acids (n-3 PUFA', 'Home parenteral nutrition (HPN', 'lipid emulsions (ILEs', 'n-3 PUFA-enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem/Lipoplus® 200\u2009mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin® MCT/LCT/Medialipide® 20%, B. Braun Melsungen AG', 'Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion', 'n-3 PUFA-enriched ILE']","['safety and tolerability', 'efficacy of the ILEs', 'combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4274352', 'cui_str': 'Chronic failure of small intestine'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0079543', 'cui_str': 'Parenteral Nutrition, Home'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C3873606', 'cui_str': 'Long chain triglyceride (substance)'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0065043', 'cui_str': 'Lipofundin'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}]",160.0,0.273049,"The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit.","[{'ForeName': 'Stanislaw', 'Initials': 'S', 'LastName': 'Klek', 'Affiliation': ""Stanley Dudrick's Memorial Hospital, General and Oncology Surgery Unit, 15 Tyniecka Street, 32-050, Skawina, Poland. klek@poczta.onet.pl.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Chambrier', 'Affiliation': 'Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet, 69495, Pierre-Benite, France.'}, {'ForeName': 'Sheldon C', 'Initials': 'SC', 'LastName': 'Cooper', 'Affiliation': 'GI Medicine - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Mindelsohn Way, Birmingham, B15 2TH, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gabe', 'Affiliation': ""St Mark's Hospital, Northwick Park, Watford Road, Harrow, HA1 3UJ, UK.""}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Kunecki', 'Affiliation': 'Wojewódzki Specjalistyczny Szpital im. M. Pirogowa w Łodzi, Oddział Chirurgii Ogólnej i Naczyniowej, ul. Wólczańska 191/195, 90-531, Łódź, Poland.'}, {'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Pironi', 'Affiliation': 'Department of Medical and Surgical Science, University of Bologna, St. Orsola-Malpighi Hospital, Via Massarenti, 9, 40138, Bologna, Italy.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Rahman', 'Affiliation': 'University College Hospital, 250 Euston Road, London, NW1 2PG, UK.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Sobocki', 'Affiliation': 'Samodzielny Publiczny Szpital Kliniczny im. Prof. dr W. Orlowskiego, Oddzial Kliniczny Zywienia i Chirurgii, ul. Czerniakowska 231, 00-416, Warszawa, Poland.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Szczepanek', 'Affiliation': ""Stanley Dudrick's Memorial Hospital, General and Oncology Surgery Unit, 15 Tyniecka Street, 32-050, Skawina, Poland.""}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Wanten', 'Affiliation': 'Radboud Universitair Medisch Centrum, Afdeling Maag-, Darm- en Leverziekten, Postbus 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Lincke', 'Affiliation': 'Medical Scientific Affairs, B. Braun Melsungen AG, Carl-Braun-Str. 1, 34212, Melsungen, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Glotzbach', 'Affiliation': 'Medical Scientific Affairs, B. Braun Melsungen AG, Carl-Braun-Str. 1, 34212, Melsungen, Germany.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Forbes', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, NR4 7TJ, UK.'}]",Trials,['10.1186/s13063-019-3994-z']
1169,31439467,Dosing Iodinated Contrast Media According to Lean Versus Total Body Weight at Abdominal CT: A Stratified Randomized Controlled Trial.,"RATIONALE AND OBJECTIVES


To compare the magnitude and interpatient variability in normalized mean hepatic enhancement (MHE) indices when dosing contrast media (CM) according to total body weight (TBW) and lean body weight (LBW).
MATERIALS AND METHODS


This ethics-approved stratified randomized controlled study allocated 280 outpatients for abdominal Computed Tomography (CT) between February-November 2018 to TBW- or LBW-dosing using computer-generated tables. CTs were acquired in portal venous phase after fixed 35-second injection of Iohexol 350. Patients with missing precontrast image, incorrect dose, or chronic kidney, liver or heart disease were excluded. The number of included patients and CM doses were: TBW arm, 51 women and 60 men, 1.22 mL/kg; LBW arm, 59 women, 1.66 mL/kg LBW, and 59 men, 1.52 mL/kg LBW. Liver attenuations were obtained from regions of interest. Values and standard deviations in MHE indices normalized to iodine dose (MHE/I) and iodine dose per kg TBW (aMHE = MHE/[I/TBW]) were compared (unpaired t tests and F-tests).
RESULTS


Cohorts were similar in age, sex, TBW, and LBW. TBW groups received more CM than LBW groups: men, 106.5 ± 20 versus 98.4 ± 11 mL, p = 0.007; women, 93.7 ± 20 versus 77.5 ± 11 mL, p < 0.0001. TBW and LBW groups showed no significant difference in MHE/I (women, 1.75 ± 0.5 versus 1.86 ± 0.6 HU/g, p = 0.31; men, 1.53 ± 0.4 versus 1.52 ± 0.4 HU/g, p = 0.90) or aMHE (women, 0.03 ± 0.01 versus 0.03 ± 0.01 HU/g/kg, p = 0.25; men, 0.02 ± 0.01 versus 0.02 ± 0.01 HU/g/kg, p = 0.52). Variances in MHE/I and aMHE were not significantly different for all groups (p > 0.05).
CONCLUSION


TBW- and LBW-based CM dosing yield a similar magnitude and interpatient variability in normalized MHE indices at routine abdominal CT.",2020,"I and aMHE were not significantly different for all groups (p > 0.05).
","['51 women and 60 men, 1.22 mL/kg; LBW arm, 59 women, 1.66 mL/kg LBW, and 59 men, 1.52 mL/kg LBW', 'Patients with missing precontrast image, incorrect dose, or chronic kidney, liver or heart disease were excluded', '280 outpatients for abdominal Computed Tomography (CT) between February-November 2018 to TBW- or LBW-dosing using computer-generated tables']","['Iohexol', 'Dosing Iodinated Contrast Media']",['total body weight (TBW) and lean body weight (LBW'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517510', 'cui_str': '1.66 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C1706074', 'cui_str': 'Table'}]","[{'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1960405', 'cui_str': 'Iodinated contrast media'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",280.0,0.107393,"I and aMHE were not significantly different for all groups (p > 0.05).
","[{'ForeName': 'Andreu F', 'Initials': 'AF', 'LastName': 'Costa', 'Affiliation': 'Department of Diagnostic Radiology, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Victoria General Building, 3rd floor, 1276 South Park Street, Halifax, NS B3H 2Y9, Canda. Electronic address: andreufcosta@gmail.com.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Peet', 'Affiliation': 'Department of Diagnostic Radiology, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Victoria General Building, 3rd floor, 1276 South Park Street, Halifax, NS B3H 2Y9, Canda.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdolell', 'Affiliation': 'Department of Diagnostic Radiology, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Victoria General Building, 3rd floor, 1276 South Park Street, Halifax, NS B3H 2Y9, Canda.'}]",Academic radiology,['10.1016/j.acra.2019.07.014']
1170,31331777,Trivalent influenza vaccination randomized control trial of pregnant women and adverse fetal outcomes.,"INTRODUCTION


The purpose of this study was to evaluate the association of influenza vaccine during pregnancy and adverse fetal outcomes. Preventing fetal death, low birth weight, small for gestational age birth and preterm birth are important potential effects of antenatal maternal influenza immunization for which there are conflicting data.
MATERIALS AND METHODS


A double-blind, randomized, placebo-controlled clinical trial of trivalent inactivated influenza vaccine was conducted in South Africa from March 2011 until after the 2012 influenza season when the infants born had reached the age of 24 weeks. Mothers were administered the vaccine or placebo during pregnancy at a gestation of 20 to 36 weeks. A comparison of rates of fetal death, low birth weight, small for gestational age birth, and preterm birth, between vaccinated and placebo groups was made. Fetal outcome differences between the groups were measured using Student's t-tests, vaccine efficacy with 95% confidence intervals, and Poisson regression for incidence rates. All analyses except fetal death excluded mothers who were administered vaccine or placebo after 34 weeks gestational age.
RESULTS


There were 2116 HIV-uninfected pregnant women age 18 to 38 years in the trial; 2005 infants were born to mothers where vaccine or placebo had been administered ≥ 14 days prior to delivery, and there were 6 miscarriages and 23 stillbirths. There was no significant vaccine efficacy (with [95% confidence interval]) on fetal death (-21.2% [-150.8, 41.4]), low birth weight (-11.1% [-42.3, 12.5]), small for gestational age birth (-9.9% [-35.6, 11.0]), or preterm birth (-21.3% [-60.5, 8.3]). Neither was vaccine efficacy demonstrated when the analysis was restricted to infants of mothers who were exposed to an influenza season (1832 outcomes available).
CONCLUSION


We did not find a beneficial effect of trivalent inactivated influenza vaccine during pregnancy on adverse fetal outcomes.",2019,"There was no significant vaccine efficacy (with [95% confidence interval]) on fetal death (-21.2% [-150.8, 41.4]), low birth weight (-11.1% [-42.3, 12.5]), small for gestational age birth (-9.9% [-35.6, 11.0]), or preterm birth (-21.3% [-60.5, 8.3]).","['pregnant women and adverse fetal outcomes', 'South Africa from March 2011 until after the 2012 influenza season when the infants born had reached the age of 24\u202fweeks', '2116 HIV-uninfected pregnant women age 18 to 38\u202fyears in the trial; 2005 infants were born to mothers where']","['influenza vaccine', 'vaccine or placebo', 'placebo', 'trivalent inactivated influenza vaccine']","['adverse fetal outcomes', 'preterm birth', 'rates of fetal death, low birth weight, small for gestational age birth, and preterm birth', 'fetal death', 'vaccine efficacy', 'low birth weight', 'small for gestational age birth', 'fetal death, low birth weight, small for gestational age birth and preterm birth', ""Student's t-tests, vaccine efficacy""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",2116.0,0.602901,"There was no significant vaccine efficacy (with [95% confidence interval]) on fetal death (-21.2% [-150.8, 41.4]), low birth weight (-11.1% [-42.3, 12.5]), small for gestational age birth (-9.9% [-35.6, 11.0]), or preterm birth (-21.3% [-60.5, 8.3]).","[{'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Colorado School of Public Health, Center for Global Health, University of Colorado School of Medicine, Aurora Colorado, 13123 E. 16(th) Ave., B055 Aurora, CO, United States; University of Colorado Denver, Dept. of Pediatric Infectious Diseases, 13123 E. 16(th) Ave, B055 Aurora, CO, United States.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Carosone-Link', 'Affiliation': 'University of Colorado Denver, Dept. of Pediatric Infectious Diseases, 13123 E. 16(th) Ave, B055 Aurora, CO, United States. Electronic address: Phyllis.CarosoneLink@ucdenver.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Madimabe', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'University of Maryland Center for Vaccine Development, 685 W Baltimore St, Baltimore, MD, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'University of Maryland Center for Vaccine Development, 685 W Baltimore St, Baltimore, MD, USA.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'Klugman', 'Affiliation': 'Bill and Melinda Gates Foundation, 500 5th Ave N, Seattle, WA, USA.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; National Institute for Communicable Diseases: a division of National Health Laboratory Service, Centre for Vaccines and Immunology, 1 Modderfontein Road, Sandringham, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.07.024']
1171,30768394,A Multisite Randomized Controlled Two-Phase Trial of the Early Start Denver Model Compared to Treatment as Usual.,"OBJECTIVE


This single-blind, randomized, multisite, intent-to-treat study was designed to replicate and extend Dawson et al.'s (Pediatrics. 2010;125: e17-e23) randomized controlled trial testing the effects of the Early Start Denver Model (ESDM), an intensive play- and routines-based intervention delivered in natural settings.
METHOD


A randomized controlled trial was conducted at 3 universities. One hundred eighteen children 14 to 24 months old with autism spectrum disorder were enrolled and randomly assigned to ESDM or community interventions for 27 months. Eighty-one children completed the full treatment course and all assessments; data from all 118 children were used in analyses. Children assigned to the ESDM intervention received 3 months of weekly parent coaching followed by 24 months of 15 hour per week (on average) 1:1 treatment weekly on average in homes or daycare settings from supervised therapy assistants while parents received coaching 4 hours monthly from a certified ESDM therapist.
RESULTS


For the primary analyses, there were time-by-group and time-by-group-by-site interactions for language outcome. In the significant 3-way interaction involving site, 2 sites showed a significant ESDM advantage and the third site showed no significant group differences. In the planned 2-way analysis that pooled data across all 3 sites, there was a significant advantage found for the ESDM group. For the secondary analyses, there were no significant differences between the ESDM and community groups involving developmental quotient, autism severity, or adaptive behavior. The treatment effect of group on language outcomes was not moderated by baseline developmental quotient, autism severity, or language.
CONCLUSION


Results of the primary analysis provide a partial replication of Dawson et al.'s 2010 language findings.
CLINICAL TRIAL REGISTRATION INFORMATION


Intensive Intervention for Toddlers with Autism; https://clinicaltrials.gov/; NCT00698997.",2019,"For the secondary analyses, there were no significant differences between the ESDM and community groups involving developmental quotient, autism severity, or adaptive behavior.","['Toddlers with Autism', 'One hundred eighteen children 14 to 24 months old with autism spectrum disorder', 'Eighty-one children completed the full treatment course and all assessments; data from all 118 children were used in analyses']","['ESDM intervention received 3 months of weekly parent coaching followed by 24 months of 15 hour per week (on average) 1:1 treatment weekly on average in homes or daycare settings from supervised therapy assistants while parents received coaching 4 hours monthly from a certified ESDM therapist', 'Early Start Denver Model (ESDM), an intensive play- and routines-based intervention delivered in natural settings', 'ESDM or community interventions']","['baseline developmental quotient, autism severity, or language', 'partial replication of Dawson et', 'developmental quotient, autism severity, or adaptive behavior']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0556976', 'cui_str': 'hours/week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0085880', 'cui_str': 'Behavior, Adaptive'}]",118.0,0.195291,"For the secondary analyses, there were no significant differences between the ESDM and community groups involving developmental quotient, autism severity, or adaptive behavior.","[{'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Rogers', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento. Electronic address: sjrogers@ucdavis.edu.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Estes', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lord', 'Affiliation': 'Weill Cornell Medicine, Cornell University, New York, NY.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Munson', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Rocha', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Winter', 'Affiliation': 'Weill Cornell Medicine, Cornell University, New York, NY.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Greenson', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Costanza', 'Initials': 'C', 'LastName': 'Colombi', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Dawson', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Vismara', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hellemann', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Whelan', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Talbott', 'Affiliation': 'University of California, Davis, MIND Institute, Sacramento.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.01.004']
1172,9743881,A randomized trial of intracervical prostaglandin gel and intravenous oxytocin in prelabor rupture of membranes with unripe cervix at term.,"In order to compare the efficacy of immediate intravenous oxytocin administration and intracervical prostaglandin E2 gel application in premature rupture of membranes with unfavorable cervices at term, 45 term pregnant patients with premature rupture of membranes were randomized into two groups. Twenty women received immediate intravenous oxytocin after cleansing enema while the rest were treated with intracervical prostaglandin E2 gel. Means of maternal age, gestational age, Bishop score at admission and the rates of nulliparity did not show any significant differences between the two groups (p > 0.05). The mean rupture to delivery time was 12.6 +/- 4.4 hours in the oxytocin group and 16.5 +/- 4.5 hours in the prostaglandin group (p < 0.01). Mean birth weights and Apgar scores were insignificant. Cesarean section rates were 24% in the oxytocin group and 5% in the other (p < 0.05). No infectious morbidity was seen in any case. In conclusion, although delivery is delayed with the intracervical prostaglandin approach, cesarean section rate is lowered without an increase in infectious morbidity.",1998,Cesarean section rates were 24% in the oxytocin group and 5% in the other (p < 0.05).,"['Twenty women received', 'premature rupture of membranes with unfavorable cervices at term, 45 term pregnant patients with premature rupture of membranes', 'prelabor rupture of membranes with unripe cervix at term']","['oxytocin', 'oxytocin administration and intracervical prostaglandin E2 gel application', 'immediate intravenous oxytocin', 'intracervical prostaglandin E2 gel', 'prostaglandin', 'intracervical prostaglandin gel and intravenous oxytocin']","['infectious morbidity', 'mean rupture to delivery time', 'Mean birth weights and Apgar scores', 'Cesarean section rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0457226', 'cui_str': 'Uneffaced cervix (finding)'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444978', 'cui_str': 'Intracervical (qualifier value)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]",45.0,0.0416802,Cesarean section rates were 24% in the oxytocin group and 5% in the other (p < 0.05).,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bilgin', 'Affiliation': 'Uludağ University Faculty of Medicine, Department of Obstetrics and Gynecology, Bursa, Turkey.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kadioğlu', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Yildirim', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cengiz', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1173,31445316,"Efficacy of ω-3 supplementation on nutritional status, skeletal muscle, and chemoradiotherapy toxicity in cervical cancer patients: A randomized, triple-blind, clinical trial conducted in a middle-income country.","OBJECTIVES


Supplementation with ω-3 has been shown to favor the preservation of body weight and skeletal muscle. The aim of this study was to evaluate the efficacy of ω-3 supplementation on nutritional status, skeletal muscle quantity and quality, and toxicity for treatment of women with cervical cancer.
METHODS


This was a randomized, triple-blinded, placebo-controlled clinical trial in women diagnosed with cervical cancer who underwent chemoradiotherapy between March 2016 and August 2017. The intervention group received four capsules with ω-3 (2.5 g/d) and the control group (CG) received the same number of identical-looking capsules with olive oil, for 45 d. Nutritional status was measured by anthropometry and Patient-Generated Subjective Global Assessment. Body composition was assessed by computed tomography. The skeletal muscle index was calculated using the range -29 to +150 HU. For skeletal muscle quality, the area comprised between -29 and +29 HU was denominated low-radiodensity skeletal muscle index and the range between +30 and +150 HU high-radiodensity skeletal muscle index, representing the skeletal muscle area with high or low intramuscular fat infiltration, respectively.
RESULTS


The study population comprised 40 patients, with an average age 44.53 ± 8.73. The intervention group maintained body weight and showed an improvement in Patient-Generated Subjective Global Assessment score. A significant reduction in skeletal muscle index was observed in both groups. However, in regard to skeletal muscle quality, patients in the intervention group preserved low- and high-radiodensity skeletal muscle index, whereas those in the control group had increased low-radiodensity skeletal muscle index and significantly reduced high-radiodensity skeletal muscle index, reflecting high intramuscular fat infiltration only in the control group. The incidence of chemotherapy toxicity was significantly lower in the intervention group.
CONCLUSIONS


The results suggest that ω-3 supplementation is effective in maintaining nutritional status, skeletal muscle quality, and reduced symptoms of chemoradiotherapy among women with cervical cancer.",2019,"The incidence of chemotherapy toxicity was significantly lower in the intervention group.
","['40 patients, with an average age 44.53 ± 8.73', 'women diagnosed with cervical cancer who underwent chemoradiotherapy between March 2016 and August 2017', 'cervical cancer patients', 'middle-income country', 'women with cervical cancer']","['ω-3 supplementation', 'control group (CG) received the same number of identical-looking capsules with olive oil', 'placebo']","['high-radiodensity skeletal muscle index', 'incidence of chemotherapy toxicity', 'low- and high-radiodensity skeletal muscle index', 'nutritional status, skeletal muscle, and chemoradiotherapy toxicity', 'low-radiodensity skeletal muscle index', 'nutritional status, skeletal muscle quality', 'Patient-Generated Subjective Global Assessment score', 'skeletal muscle index', 'Body composition', 'nutritional status, skeletal muscle quantity and quality, and toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]",150.0,0.0635239,"The incidence of chemotherapy toxicity was significantly lower in the intervention group.
","[{'ForeName': 'Mariah Azevedo', 'Initials': 'MA', 'LastName': 'Aredes', 'Affiliation': 'National Cancer Institute José Alencar Gomes da Silva, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Alex Oliveira', 'Initials': 'AO', 'LastName': 'da Camara', 'Affiliation': 'National Cancer Institute José Alencar Gomes da Silva, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Nathália Silva', 'Initials': 'NS', 'LastName': 'de Paula', 'Affiliation': 'National Cancer Institute José Alencar Gomes da Silva, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Karla Yasmin Dias', 'Initials': 'KYD', 'LastName': 'Fraga', 'Affiliation': 'Institute of Nutrition Josué de Castro of Federal University of Rio de Janeiro J, Rio de Janeiro, Brazil.'}, {'ForeName': 'Maria das Graças Tavares', 'Initials': 'MDGT', 'LastName': 'do Carmo', 'Affiliation': 'Institute of Nutrition Josué de Castro of Federal University of Rio de Janeiro J, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gabriela Villaça', 'Initials': 'GV', 'LastName': 'Chaves', 'Affiliation': 'Postgraduate Program in Oncology, Brazilian National Cancer Institute, Rio de Janeiro, Brazil. Electronic address: Gabrielavc@gmail.com.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.06.009']
1174,31442441,A phase I randomized safety study of a single-size silicone rubber diaphragm used with or without a lactic-acid-containing diaphragm gel.,"OBJECTIVES


To evaluate a lactic-acid-containing diaphragm gel (Contragel®) approved outside the United States for use with a silicone rubber diaphragm (Caya®). The study gel is being evaluated as a safer alternative to nonoxynol-9 (N-9) gel, which has been associated with risk of increasing susceptibility to human immunodeficiency virus (HIV).
STUDY DESIGN


This was a Phase I randomized, parallel study evaluating the safety of the novel diaphragm gel versus hydroxyethylcellulose (HEC) universal placebo gel delivered by the study diaphragm for two 7-day test cycles of daily use, without and with intercourse. The primary clinical safety endpoint was treatment emergent adverse events. Mucosal safety endpoints included colposcopic findings, anti-Escherichia coli activity of endocervical and vaginal fluid, immune mediators, Nugent score and ectocervical immune cell density. Endpoints were assessed prior to each test cycle and at day 7 of each test cycle. We compared the two independent groups and also evaluated paired changes from baseline in each gel cohort.
RESULTS


Twenty-three participants used the study diaphragm with the novel gel (n=11) or with HEC (n=12). Use of either gel resulted in few genital AEs and no colposcopic findings. There were no differences in ectocervical histology and lymphocyte density or phenotype between the two cohorts at baseline or after each test cycle. We found no clinically important differences in the anti-microbial (anti Escherichia coli) activity of endocervical or vaginal fluid or concentrations of genital immune mediators (e.g. anti-inflammatory secretory leukocyte protease inhibitor (SLPI) or pro-inflammatory mediator RANTES) between the two gel cohorts at any visit. There were no important paired changes from baseline among participants using either gel in Nugent score, ectocervical histology or anti-microbial activity of genital secretions.
CONCLUSIONS


We found no clinically significant differences in clinical and mucosal safety endpoints between the two cohorts. The mucosal safety profiles of the study gel and HEC placebo gel were similar.
IMPLICATIONS


Our data demonstrate no clinically important differences between the safety profiles of the lactic-acid-containing diaphragm gel versus HEC placebo gel when used with the study diaphragm. N-9 can no longer be used with contraceptive diaphragms in high HIV prevalence regions. Although larger studies are needed, the novel gel appears safe for use with the study diaphragm, which is the first over-the-counter, non-hormonal, diaphragm.",2019,"There were no important paired changes from baseline among participants using either gel in Nugent score, ectocervical histology or anti-microbial activity of genital secretions.
",['Twenty-three participants used the study diaphragm with the novel gel (n=11) or with HEC (n=12'],"['HEC placebo gel', 'diaphragm gel versus HEC placebo gel', 'silicone rubber diaphragm (Caya®', 'N-9', 'lactic-acid-containing diaphragm gel (Contragel®', 'nonoxynol-9 (N-9) gel', 'single-size silicone rubber diaphragm used with or without a lactic-acid-containing diaphragm gel', 'novel diaphragm gel versus hydroxyethylcellulose (HEC) universal placebo gel']","['Nugent score, ectocervical histology or anti-microbial activity of genital secretions', 'ectocervical histology and lymphocyte density or phenotype', 'emergent adverse events', 'clinical and mucosal safety endpoints', 'colposcopic findings, anti-Escherichia coli activity of endocervical and vaginal fluid, immune mediators, Nugent score and ectocervical immune cell density', 'mucosal safety profiles']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}]","[{'cui': 'C0318598', 'cui_str': 'Human enteric calicivirus (organism)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0037110', 'cui_str': 'Silicone Rubber'}, {'cui': 'C0064582', 'cui_str': 'Lactic acid'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0132776', 'cui_str': 'Nonoxynol-9'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0856484', 'cui_str': 'Diaphragm use'}, {'cui': 'C0063131', 'cui_str': 'hydroxyethyl cellulose'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C4521006', 'cui_str': 'Endocervical'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0162339', 'cui_str': 'Cell Density'}]",23.0,0.0886453,"There were no important paired changes from baseline among participants using either gel in Nugent score, ectocervical histology or anti-microbial activity of genital secretions.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Thurman', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, 601 Colley Ave, Norfolk, VA, USA 23507. Electronic address: thurmaar@evms.edu.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Cunningham', 'Affiliation': 'Healthcare Delivery Science Program, Healthcare Analytics Program, Eastern Virginia Medical School, 651 Colley Ave, Norfolk, VA, USA 23507.'}, {'ForeName': 'Raina', 'Initials': 'R', 'LastName': 'Fichorova', 'Affiliation': ""Laboratory of Genital Tract Biology, Brigham and Women's Hospital, Harvard University, 221 Longwood Ave., Boston, MA, 02115.""}, {'ForeName': 'Betsy C', 'Initials': 'BC', 'LastName': 'Herold', 'Affiliation': 'Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY 10461.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'Magee-Womens Research Institute and the University of Pittsburgh, 204 Craft Ave., Pittsburgh, PA 15213.'}, {'ForeName': 'Neelima', 'Initials': 'N', 'LastName': 'Chandra', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, 601 Colley Ave, Norfolk, VA, USA 23507.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Doncel', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, 601 Colley Ave, Norfolk, VA, USA 23507; CONRAD, Eastern Virginia Medical School, 1911 North Fort Myer Drive, Arlington, Virginia, USA 22209.'}]",Contraception,['10.1016/j.contraception.2019.06.004']
1175,31439506,Extended Lymph Node Dissection for Bladder Cancer: Do Clinical Trials Rule Out a Benefit?,"Although previous studies indicated a therapeutic benefit from superextended or extended lymph node dissection in bladder cancer patients undergoing radical cystectomy, the first prospective randomized trial could not confirm a significant survival benefit. With multimodal approaches including neoadjuvant or adjuvant chemotherapy as a gold standard, demonstrating any benefit may become even more difficult.",2020,"Although previous studies indicated a therapeutic benefit from superextended or extended lymph node dissection in bladder cancer patients undergoing radical cystectomy, the first prospective randomized trial could not confirm a significant survival benefit.","['bladder cancer patients undergoing radical cystectomy', 'Bladder Cancer']",['neoadjuvant or adjuvant chemotherapy'],[],"[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]",[],,0.116947,"Although previous studies indicated a therapeutic benefit from superextended or extended lymph node dissection in bladder cancer patients undergoing radical cystectomy, the first prospective randomized trial could not confirm a significant survival benefit.","[{'ForeName': 'Matthias M', 'Initials': 'MM', 'LastName': 'Heck', 'Affiliation': 'Department of Urology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany. Electronic address: matthias.heck@tum.de.'}, {'ForeName': 'Jürgen E', 'Initials': 'JE', 'LastName': 'Gschwend', 'Affiliation': 'Department of Urology, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}]",European urology focus,['10.1016/j.euf.2019.08.003']
1176,7781174,Induction of labor using prostaglandin E2 (PGE2) vaginal gel in triacetin base. An efficacy study comparing two dosage regimens.,"OBJECTIVE


To compare two dosage regimens for the administration of vaginal prostaglandin gel in triacetin base for induction of labor.
METHODS


Seventy subjects planned for elective induction of labor at term were randomized to treatment with PGE2 vaginal gel every 6 or 12 hours. The 6-hourly group received an initial dose of 1 mg, followed by 2 mg at 6 hour intervals for a maximum of two additional doses if not in active labor. The 12-hourly group had an initial dose of 2 mg followed by two additional doses at 12 hour intervals if not in active labor.
RESULTS


Successful induction rate was higher in the 12-hourly as compared to 6-hourly gel regimen (100% vs. 91%, P > 0.05). Twelve hours after the initial dose, delivery occurred in 34% delivery had occurred in 57% and 37% respectively (P < 0.01). We found no difference in the induction-active labor interval (P > 0.05), and the induction-delivery interval (P > 0.05) between the two groups. Active labor followed a single dose of gel in 66% of the 12-hourly group compared to 40% of the 6-hourly group (P < 0.01). Syntocinon augmentation was needed in 6% of subjects in the 12-hourly group as compared to 26% in the 6-hourly group (P < 0.01). The cesarean section rate was similar in both groups. Uterine hyperstimulation occurred less frequently in the 12-hourly group (P < 0.05). The perinatal outcome was similar in both groups.
CONCLUSIONS


The 12-hourly regimen was more effective than the 6-hourly regimen in initiating labor. The majority of the subjects in the 12 hourly group achieved labor following a single dose of gel. Induction delivery interval, however, was similar in both groups.",1995,Uterine hyperstimulation occurred less frequently in the 12-hourly group (P < 0.05).,['Seventy subjects planned for elective induction of labor at term'],"['PGE2 vaginal gel', 'vaginal prostaglandin gel', 'prostaglandin E2 (PGE2) vaginal gel']","['induction-active labor interval', 'induction-delivery interval', 'Successful induction rate', 'Uterine hyperstimulation', 'cesarean section rate', 'Syntocinon augmentation']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}]","[{'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0042257', 'cui_str': 'Vaginal Jelly'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0233081', 'cui_str': 'Normal labor (finding)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0269842', 'cui_str': 'Hypertonic uterine dysfunction (disorder)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0592155', 'cui_str': 'Syntocinon'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]",,0.0730058,Uterine hyperstimulation occurred less frequently in the 12-hourly group (P < 0.05).,"[{'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Seeras', 'Affiliation': 'Department of Obstetrics and Gynaecology, College of Medicine, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Olatunbosun', 'Affiliation': ''}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Pierson', 'Affiliation': ''}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Turnell', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1177,8462190,Treatment of idiopathic infertility with testosterone undecanoate. A double blind study.,"This study refers to 50 couples treated for subfertility. Twenty five of these patients were treated with TU (Testosterone Ur econoate), the remaining 25 received placebo. Sperm characteristics, including ejaculate volume, pH, sperm density, morphology, motility, total testosterone, FSH, LH, DHT and E2 were evaluated both before and after treatment. A statistically significant increase of DHT levels was noticed after TU administration, whereas a marginally significant improvement of sperm morphology was present. Serum FSH concentrations, decreased significantly in the TU group whereas serum LH presented a slight but not statistically significant decrease; 4 pregnancies were achieved by the TU group whereas none were achieved by the patients belonging to the placebo group. The administration of TU per os to patients with idiopathic oligospermia presents a demonstrably positive effect.",1993,"Serum FSH concentrations, decreased significantly in the TU group whereas serum LH presented a slight but not statistically significant decrease; 4 pregnancies were achieved by the TU group whereas none were achieved by the patients belonging to the placebo group.","['patients with idiopathic oligospermia', '50 couples treated for subfertility']","['placebo', 'TU (Testosterone Ur econoate', 'TU', 'testosterone undecanoate']","['sperm morphology', 'DHT levels', 'Sperm characteristics, including ejaculate volume, pH, sperm density, morphology, motility, total testosterone, FSH, LH, DHT and E2', 'Serum FSH concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0028960', 'cui_str': 'Oligoasthenoteratozoospermia'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0729353', 'cui_str': 'Sub-Fertility'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0076195', 'cui_str': 'testosterone undecanoate'}]","[{'cui': 'C0428011', 'cui_str': 'Sperm morphology (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0037868', 'cui_str': 'Sperm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0427992', 'cui_str': 'Semen volume measurement'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",50.0,0.115462,"Serum FSH concentrations, decreased significantly in the TU group whereas serum LH presented a slight but not statistically significant decrease; 4 pregnancies were achieved by the TU group whereas none were achieved by the patients belonging to the placebo group.","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Gregoriou', 'Affiliation': 'Second Department of Obstetrics and Gynecology, University of Athens.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Papadias', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gargaropoulos', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Konidaris', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Kontogeorgi', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kalampokas', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1178,7994879,Role of goserelin-depot in the clinical management of uterine fibroids.,"On 30 women suffering from uterine fibroids, the monthly subcutaneous administration of goserelin depot (3.6 mg) for 6 (n = 22) or 12 months (n = 8) induced an about 50% shrinkage of uterus and fibroid volume, and within 3 months, an increase in the haematocrit value, with no metabolic side effects or detectable bone demineralization, evaluated by single photon absortiometry at distal radius. Both uterine and fibroid volumes reversed to pretreatment values after 3 months of goserelin depot withdrawal. In comparison with untreated subjects, on another 10 patients a three month administration of goserelin depot reduced the loss of blood during the surgical removal of the uterus or fibroids. Present data indicate that goserelin depot is effective and relatively safe in the medical management of uterine fibroids. Although, goserelin depot cannot yet be proposed as a definite medical therapy, it may represent a useful instrument in the presurgical management of uterine fibroids.",1994,Both uterine and fibroid volumes reversed to pretreatment values after 3 months of goserelin depot withdrawal.,"['uterine fibroids', '30 women suffering from uterine fibroids']","['goserelin depot', 'goserelin-depot']",['loss of blood during the surgical removal of the uterus or fibroids'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}]","[{'cui': 'C0120107', 'cui_str': 'Goserelin'}]","[{'cui': 'C0005768'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}]",30.0,0.0187203,Both uterine and fibroid volumes reversed to pretreatment values after 3 months of goserelin depot withdrawal.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cagnacci', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Cagliari, Italy.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Paoletti', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Soldani', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Angiolucci', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Arangino', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falqui', 'Affiliation': ''}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Melis', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1179,32438071,Baseline urinary metabolites predict albuminuria response to spironolactone in type 2 diabetes.,"The mineralocorticoid receptor antagonist spironolactone significantly reduces albuminuria in subjects with diabetic kidney disease, albeit with a large variability between individuals. Identifying novel biomarkers that predict response to therapy may help to tailor spironolactone therapy. We aimed to identify a set of metabolites for prediction of albuminuria response to spironolactone in subjects with type 2 diabetes. Systems biology molecular process analysis was performed a priori to identify metabolites linked to molecular disease processes and drug mechanism of action. Individual subject data and urine samples were used from 2 randomized placebo controlled double blind clinical trials (NCT01062763, NCT00381134). A urinary metabolite score was developed to predict albuminuria response to spironolactone therapy using penalized ridge regression with leave-one-out cross validation. Bioinformatic analysis identified a set of 18 metabolites linked to a diabetic kidney disease molecular model and potentially affected by spironolactone mechanism of action. Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively. In the test cohort, UACR reduction was higher in the lowest tertile of the baseline urinary metabolite score compared with middle and upper tertiles -58% (25th to 75% percentile -78 to 33), -28% (25th to 75% percentile -46 to 8), -40% (25th to 75% percentile -52% to 31), respectively, P = 0.001 for trend). In the replication cohort, UACR reduction was -54% (25th to 75% percentile -65 to -50), -41 (25th to 75% percentile -46% to 30), and -17% (25th to 75% percentile -36 to 5), respectively, P = 0.010 for trend). We identified a set of 18 urinary metabolites through systems biology to predict albuminuria response to spironolactone in type 2 diabetes. These data suggest that urinary metabolites may be used as a tool to tailor optimal therapy and move in the direction of personalized medicine.",2020,"Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively.","['subjects with diabetic kidney disease', 'type 2 diabetes', 'subjects with type 2 diabetes']","['spironolactone', 'mineralocorticoid receptor antagonist spironolactone', 'Spironolactone', 'spironolactone therapy', 'placebo']","['baseline urinary metabolite score', 'UACR reduction', 'albuminuria response', 'UACR relative']","[{'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0356557,"Spironolactone reduced UACR relative to placebo by median -42% (25th to 75% percentile -65 to 6) and -29% (25th to 75% percentile -37 to -1) in the test and replication cohorts, respectively.","[{'ForeName': 'Skander', 'Initials': 'S', 'LastName': 'Mulder', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perco', 'Affiliation': 'Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Oxlund', 'Affiliation': 'University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Uzma F', 'Initials': 'UF', 'LastName': 'Mehdi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hankemeier', 'Affiliation': 'Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Ib A', 'Initials': 'IA', 'LastName': 'Jacobsen', 'Affiliation': 'University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Pena', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. Electronic address: m.pena@umcg.nl.'}]",Translational research : the journal of laboratory and clinical medicine,['10.1016/j.trsl.2020.04.010']
1180,8281707,Endocrine changes and follicular development in patients during ovulation induction using Goserelin and different gonadotropin treatments.,"The aim of this study was to compare endocrine changes and the follicular development in patients receiving pure FSH alone or in association with LH after desensitization with an LH-RH agonist depot. Thirty four cycles were selected for this prospective randomized study. Desensitization was obtained using Goserelin the cycle before the stimulation. Induction of ovulation for IUI was carried out with 225 IU/day of pure FSH or with 225 IU/day of hMG. The number of days and ampules required for follicular maturation were equivalent in the two groups. The same number of follicles were developed, while different, but not significant, pregnancy rates were obtained. Estradiol values at the end of stimulation were significantly lower for FSH group. In conclusion the contemporary administration of LH with FSH does not exert any effect on follicular development, but it seems to facilitate E2 synthesis, probably providing more substrate for the aromatization process.",1993,Estradiol values at the end of stimulation were significantly lower for FSH group.,"['patients during ovulation induction using', 'Thirty four cycles', 'patients receiving pure FSH alone or in association with LH after desensitization with an LH-RH agonist depot']","['LH with FSH', 'Goserelin and different gonadotropin treatments']","['number of days and ampules required for follicular maturation', 'pregnancy rates', 'Endocrine changes and follicular development', 'Estradiol values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029967', 'cui_str': 'Ovulation Induction'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0556520', 'cui_str': 'Desensitization (Psychology)'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319773', 'cui_str': 'Ampule'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0344376,Estradiol values at the end of stimulation were significantly lower for FSH group.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gerli', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Perugia, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Villani', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1181,7923801,Pain evaluation during carbon dioxide laser vaporization for cervical intraepithelial neoplasia: a randomized trial.,63 pts affected by CIN of various degrees were randomly divided into 3 groups in order to evaluate the pain experienced during laser vaporization of the lesion. All pts were premenopausal and ages ranged between 19 and 39 years. 21 pts received Naproxene Sodium (550 mg) 30 minutes before surgery; 21 pts received placebo and 21 pts received no drug. Laser vaporization was performed with a Coherent System 451 CO2 laser with a power setting of 28 W/cm2 and a spot size of 1.8 mm. The severity of pain was assessed by means of a Visual Analogue Scale. The mean VAS value was 19 for the group treated with Naproxene Sodium; the mean VAS value was 20 for the placebo group and 23 for the group which received no pre-operative drug. Analysis of data from the 3 groups showed no statistically significant difference. Analgesia or anaesthesia before laser surgery for CIN is not a necessity.,1994,Analysis of data from the 3 groups showed no statistically significant difference.,"['63 pts affected by CIN of various degrees', 'All pts were premenopausal and ages ranged between 19 and 39 years', 'cervical intraepithelial neoplasia']","['placebo', 'carbon dioxide laser vaporization', 'Analgesia or anaesthesia before laser surgery for CIN', 'Laser vaporization', 'Naproxene Sodium', 'laser vaporization of the lesion']","['Pain evaluation', 'severity of pain', 'mean VAS value']","[{'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0581699', 'cui_str': 'Vaporization'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0023087', 'cui_str': 'Laser Surgery'}, {'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0272116,Analysis of data from the 3 groups showed no statistically significant difference.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Frega', 'Affiliation': 'II Clinic of Obstetrics and Gynecology, University of Rome La Sapienza.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stentella', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Di Renzi', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': ''}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Palazzetti', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Del Vescovo', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ciccarone', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pachi', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1182,7923804,Systemic interferon therapy for female florid genital condylomata.,"A prospective randomized study comparing systemic interferon therapy with placebo in women with florid genital condylomata was carried out. A first group of 22 patients received alpha-interferon (Alfaferone: Alfa-Wassermann Bologna, Italy). 3 x 10(6) IU by i.m. injection every other day for four weeks (total of 12 injections). A second group of 20 patients was treated with a placebo. All patients, before therapy, were submitted to a colposcopic and vulvoscopic examination, a Pap smear and biopsy, in order to confirm the clinical diagnosis. Controls were carried out on all patients as a distance of three, six and twelve months from the end of treatment using colpocytologic, colposcopic and vulvoscopic examinations. One year after the termination of the therapy with interferon 45.4% of patients had a complete recovery compared with 10% of spontaneous recovery in the control group (p = 0.028). The systemic side effects of alfa-interferon, though very frequent, did not limit the use of the product. Our results suggest that systemic alfa-interferon treatment is effective in female genital condylomata, above all in those patients with multifocal florid lesions, both in terms of complete remission and number of relapses.",1994,One year after the termination of the therapy with interferon 45.4% of patients had a complete recovery compared with 10% of spontaneous recovery in the control group (p = 0.028).,"['women with florid genital condylomata', 'female florid genital condylomata']","['Systemic interferon therapy', 'placebo', 'systemic alfa-interferon', 'alpha-interferon (Alfaferone: Alfa-Wassermann Bologna, Italy', 'alfa-interferon', 'systemic interferon therapy with placebo']",['complete recovery'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0279030', 'cui_str': 'Interferon therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.0296772,One year after the termination of the therapy with interferon 45.4% of patients had a complete recovery compared with 10% of spontaneous recovery in the control group (p = 0.028).,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gentile', 'Affiliation': '1st Obstetric and Gynecologic Clinic, University of Bologna, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Formelli', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Busacchi', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pelusi', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1183,9478315,17-alpha-Hydroxyprogesterone caproate and natural progesterone in assisted reproduction: a comparative study.,"The use of luteal phase support has been demonstrated in patients undergoing an IVF/ET procedure. This study was designed to compare the absorption and the efficacy of two different luteal supports: 17-alpha-hydroxyprogesterone caproate (Lentogest, AMSA, Italy) and natural Progesterone (Prontogest, AMSA, Italy). A total of 80 patients received luteal supplementation with 50 mg of natural P/day intramuscularly, until beta-hCG evaluation. Then, in case of positive beta-hCG, patients were randomly divided into two groups (A and B) in order to compare two different protocols: Group A, 17-OHPc (341 mg once a week) and Group B, natural P (50 mg/day) both intramuscularly and extended for 10-12 weeks. Our study showed that the treatment with 17-OHPc results in a higher percentage of pregnancy rate compared to natural P, but the differences are not statistically significant. Thus, we emphasize that 17-OHPc preparation for better acceptance appears to be the most suitable and comfortable method for luteal phase support.",1997,"Our study showed that the treatment with 17-OHPc results in a higher percentage of pregnancy rate compared to natural P, but the differences are not statistically significant.","['patients undergoing an IVF/ET procedure', '80 patients received']","['luteal supplementation with 50 mg of natural P/day intramuscularly, until beta-hCG evaluation', '17-OHPc', '17-alpha-Hydroxyprogesterone caproate and natural progesterone', '17-alpha-hydroxyprogesterone caproate (Lentogest, AMSA, Italy) and natural Progesterone (Prontogest, AMSA, Italy']",['pregnancy rate'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0044971', 'cui_str': 'hydroxyprogesterone caproate (USP)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0002699', 'cui_str': 'Amsacrine'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",80.0,0.0205858,"Our study showed that the treatment with 17-OHPc results in a higher percentage of pregnancy rate compared to natural P, but the differences are not statistically significant.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abate', 'Affiliation': 'Papardo Hospital, Messina.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brigandì', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Costabile', 'Affiliation': ''}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Abate', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Balzano', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Perino', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1184,9478327,Intramuscular versus vaginal progesterone in assisted reproduction: a comparative study.,"The effectiveness and the absorption of two progesterone (P) presentations have been compared for luteal phase support of patients aged < or = 37 years undergoing an in vitro fertilization (IVF) procedure for the first time, who were stimulated after pituitary desensitization with gonadotrophin releasing hormone agonists (GnRHa). All of them had two ovaries, normal ovarian functions and normal endometrial morphology: the indication for the assisted reproductive technique was the tubal factor. Two hundred and fifty patients were randomly allocated to two groups in order to compare two treatment protocols: Group A: natural i.m. P (50 mg/day, Prontogest, AMSA, Italy); Group B: micronized vaginal P (200 mg/day Esolut, Angelini, Italy). We were able to show that the i.m. P resulted in a higher percentage of pregnancies than the vaginal preparation, with statistically significant differences. We recommend the use of injectable P, and suggest reserving intravaginal P as a second choice for patients who cannot tolerate intramuscular administration.",1997,"P resulted in a higher percentage of pregnancies than the vaginal preparation, with statistically significant differences.","['patients who cannot tolerate intramuscular administration', 'Two hundred and fifty patients', 'patients aged < or = 37 years undergoing an in vitro fertilization (IVF) procedure for the first time, who were stimulated after pituitary desensitization with']","['Intramuscular versus vaginal progesterone', 'gonadotrophin releasing hormone agonists (GnRHa', 'micronized vaginal P', 'progesterone (P) presentations']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0556520', 'cui_str': 'Desensitization (Psychology)'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}]",[],250.0,0.0709563,"P resulted in a higher percentage of pregnancies than the vaginal preparation, with statistically significant differences.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Perino', 'Affiliation': 'Papardo Hospital, Messina, Italy.'}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Brigandì', 'Affiliation': ''}, {'ForeName': 'F G', 'Initials': 'FG', 'LastName': 'Abate', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Costabile', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Balzano', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abate', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1185,31811952,"Correction of Dyssynergic Defecation, but Not Fiber Supplementation, Reduces Symptoms of Functional Dyspepsia in Patients With Constipation in a Randomized Trial.","BACKGROUND & AIMS


Patients with functional dyspepsia are believed to have increased sensitivity of the gastrointestinal tract, and some also have functional constipation. We investigated whether in patients with functional dyspepsia, correction of dyssynergic defecation can reduce postprandial fullness.
METHODS


We performed a parallel trial at 2 referral centers in Spain, from June 2016 through January 2018 of 50 patients who fulfilled the Rome IV criteria for functional dyspepsia with postprandial distress syndrome and functional constipation and dyssynergic defecation. After a 2-week pretreatment phase, the patients were randomly assigned to groups that learned to correct dyssynergic defecation (2-3 sessions of biofeedback combined with instructions for daily exercise; n = 25) or received dietary fiber supplementation (3.5 g plantago ovata per day; n = 25) for 4 weeks. The primary outcome was change in postprandial abdominal fullness, measured daily on a scale of 0-10, during the last 7 days treatment phase vs the last 7 days of the pretreatment phase. Anal gas evacuations were measured (by an event marker) during the last 2 days of the pretreatment vs treatment phases.
RESULTS


Biofeedback treatment corrected dyssynergic defecation in 19/25 patients; corrected dyssynergic defection reduced postprandial fullness by 22%±1% in these patients (P < .001), and reduced the number of anal evacuations by 21%±8% (P = .009). Fiber supplementation did not reduce postprandial fullness or anal evacuations (P ≤ .023 between groups for both parameters in the intent to treat analysis).
CONCLUSIONS


Diagnosis and correction of dyssynergic defecation reduces dyspeptic symptoms by more than 20% in patients with functional dyspepsia and associated constipation. Dietary fiber supplementation does not reduce symptoms in these patients. ClinicalTrials.gov no: NCT02956187.",2020,"Fiber supplementation did not reduce postprandial fullness or anal evacuations (P ≤ .023 between groups for both parameters in the intent to treat analysis).
","['patients with functional dyspepsia, correction of dyssynergic defecation can reduce postprandial fullness', 'Patients With Constipation', 'Patients with functional dyspepsia', '2 referral centers in Spain, from June 2016 through January 2018 of 50 patients who fulfilled the Rome IV criteria for functional dyspepsia with postprandial distress syndrome and functional constipation and dyssynergic defecation']","['Fiber supplementation', 'Dietary fiber supplementation', 'learned to correct dyssynergic defecation (2-3 sessions of biofeedback combined with instructions for daily exercise; n = 25) or received dietary fiber supplementation']","['constipation', 'postprandial abdominal fullness, measured daily on a scale of 0-10', 'dyssynergic defecation', 'number of anal evacuations', 'dyspeptic symptoms', 'Functional Dyspepsia', 'dyssynergic defection reduced postprandial fullness', 'Anal gas evacuations', 'postprandial fullness or anal evacuations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia (disorder)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional (disorder)'}]","[{'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0556106', 'cui_str': 'Dietary fiber supplementation (product)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0235318', 'cui_str': 'Fullness abdominal'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia (disorder)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}]",,0.234526,"Fiber supplementation did not reduce postprandial fullness or anal evacuations (P ≤ .023 between groups for both parameters in the intent to treat analysis).
","[{'ForeName': 'Jose-Walter', 'Initials': 'JW', 'LastName': 'Huaman', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain; Department of Gastroenterology, University Hospital General of Catalonia, San Cugat del Valles, Spain.""}, {'ForeName': 'Marianela', 'Initials': 'M', 'LastName': 'Mego', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain; Department of Gastroenterology, University Hospital General of Catalonia, San Cugat del Valles, Spain.""}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Bendezú', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain; Department of Gastroenterology, University Hospital General of Catalonia, San Cugat del Valles, Spain.""}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Monrroy', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Samino', 'Affiliation': 'Metabolomics Platform, Campus Sescelades, Universitat Rovira i Virgili, Tarragona, Spain; Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas, Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Accarino', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain.""}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Saperas', 'Affiliation': 'Department of Gastroenterology, University Hospital General of Catalonia, San Cugat del Valles, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Azpiroz', 'Affiliation': ""Digestive System Research Unit, University Hospital Vall d'Hebron, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Electronic address: azpiroz.fernando@gmail.com.""}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.11.048']
1186,8330429,An attempt at real prophylaxis of primary dysmenorrhea: comparison between meclofenamate sodium and naproxen sodium.,"Dysmenorrhea is a widespread phenomenon, affecting mainly young nulliparous women, often inducing difficulties in study or in work. Its pathogenesis involves a release of local vasoconstrictors like Prostaglandins and Leukotrienes. Modern therapy is based firstly on the administration of prostaglandin-Synthetase Inhibitors or Contraceptive Pills, with the aim of reducing the menstrual excess of pain inducing substances. In order to achieve more efficacy, on the basis of the already proven effectiveness of the Non Steroid Anti-Inflammatory Drugs (NSAID)s in this field, we recently set out to prevent dysmenorrhea in a double-blind randomized study with Meclofenamate Sorium and Naproxen Sodium. Through the observation of the drop in Basal Body Temperature which usually precedes menstrual flow, we were able to instruct our patients in the earlier recognition of impending menstrual onset, leading to earlier prevention of Prostaglandin and Leukotriene release. Meclofenamate Sodium in particular led to considerable pain reduction, with very good patient compliance and without significant complications, probably of its additional receptor effect.",1993,"Meclofenamate Sodium in particular led to considerable pain reduction, with very good patient compliance and without significant complications, probably of its additional receptor effect.","['young nulliparous women', 'primary dysmenorrhea']","['Meclofenamate Sorium and Naproxen Sodium', 'Meclofenamate Sodium', 'meclofenamate sodium and naproxen sodium']","['Dysmenorrhea', 'pain reduction']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}]","[{'cui': 'C1289957', 'cui_str': 'Meclofenamate'}, {'cui': 'C0546873', 'cui_str': 'Naproxen sodium'}, {'cui': 'C0025041', 'cui_str': 'Meclofenamate Sodium'}]","[{'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0331387,"Meclofenamate Sodium in particular led to considerable pain reduction, with very good patient compliance and without significant complications, probably of its additional receptor effect.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Benassi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Parma, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bertani', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Avanzini', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1187,31681981,Improved Quality of Death and Dying in Care Homes: A Palliative Care Stepped Wedge Randomized Control Trial in Australia.,"OBJECTIVES


Mortality in care homes is high, but care of dying residents is often suboptimal, and many services do not have easy access to specialist palliative care. This study examined the impact of providing specialist palliative care on residents' quality of death and dying.
DESIGN


Using a stepped wedge randomized control trial, care homes were randomly assigned to crossover from control to intervention using a random number generator. Analysis used a generalized linear and latent mixed model. The trial was registered with ANZCTR: ACTRN12617000080325.
SETTING


Twelve Australian care homes in Canberra, Australia.
PARTICIPANTS


A total of 1700 non-respite residents were reviewed from the 12 participating care homes. Of these residents, 537 died and 471 had complete data for analysis. The trial ran between February 2017 and June 2018.
INTERVENTION


Palliative Care Needs Rounds (hereafter Needs Rounds) are monthly hour-long staff-only triage meetings to discuss residents at risk of dying without a plan in place. They are chaired by a specialist palliative care clinician and attended by care home staff. A checklist is followed to guide discussions and outcomes, focused on anticipatory planning.
MEASUREMENTS


This article reports secondary outcomes of staff perceptions of residents' quality of death and dying, care home staff confidence, and completion of advance care planning documentation. We assessed (1) quality of death and dying, and (2) staff capability of adopting a palliative approach, completion of advance care plans, and medical power of attorney.
RESULTS


Needs Rounds are associated with staff perceptions that residents had a better quality of death and dying (P < .01; 95% confidence interval [CI] = 1.83-12.21), particularly in the 10 facilities that complied with the intervention protocol (P < .01; 95% CI = 6.37-13.32). Staff self-reported perceptions of capability increased (P < .01; 95% CI = 2.73-6.72).
CONCLUSION


The data offer evidence for monthly triage meetings to transform the lives, deaths, and care of older people residing in care homes. J Am Geriatr Soc 68:305-312, 2020.",2020,"Staff self-reported perceptions of capability increased (P < .01; 95% CI = 2.73-6.72).
","['Twelve Australian care homes in Canberra, Australia', 'A total of 1700 non-respite residents were reviewed from the 12 participating care homes', 'The trial ran between February 2017 and June 2018', 'Care Homes']",[],"['quality of death and dying', 'quality of death and dying, and (2) staff capability of adopting a palliative approach, completion of advance care plans, and medical power of attorney', 'Improved Quality of Death and Dying']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]",[],"[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4544311', 'cui_str': 'Advance care plan (record artifact)'}, {'cui': 'C0524772', 'cui_str': 'Medical Power of Attorney'}]",12.0,0.204914,"Staff self-reported perceptions of capability increased (P < .01; 95% CI = 2.73-6.72).
","[{'ForeName': 'Wai-Man', 'Initials': 'WM', 'LastName': 'Liu', 'Affiliation': 'Australian National University, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Koerner', 'Affiliation': 'University of Canberra, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'University Technology Sydney, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Johnston', 'Affiliation': 'Calvary Public Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Samara', 'Affiliation': 'Calvary Public Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chapman', 'Affiliation': 'Australian National University, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Forbat', 'Affiliation': 'Australian Catholic University, Canberra, Australian Capital Territory, Australia.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16192']
1188,32437937,Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens.,"OBJECTIVES


This study investigated causes of fever in the primary levels of care in Southeast Asia, and evaluated whether C-reactive protein (CRP) could distinguish bacterial from viral pathogens.
METHODS


Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5 °C) or history of fever (<14 days) in Thailand and Myanmar.
RESULTS


Of 773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected. Influenza virus type A was detected in 85/227 cases (37.5%), followed by dengue virus (30 cases, 13.2%), respiratory syncytial virus (24 cases, 10.6%) and Leptospira spp. (nine cases, 4.0%). Clinical outcomes were similar between patients with a bacterial or a viral organism, regardless of antibiotic prescription. CRP was higher among patients with a bacterial organism compared with those with a viral organism (median 18 mg/L, interquartile range [10-49] versus 10 mg/L [≤8-22], p = 0.003), with an area under the curve of 0.65 (95% CI 0.55-0.75).
CONCLUSIONS


Serious bacterial infections requiring antibiotics are an exception rather than the rule in the first line of care. CRP testing could assist in ruling out such cases in settings where diagnostic uncertainty is high and routine antibiotic prescription is common. The original CRP randomised controlled trial was registered with ClinicalTrials.gov, number NCT02758821.",2020,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","['fever in the primary levels of care in Southeast Asia', '773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected', 'Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5˚C) or history of fever (<14 days) in Thailand and Myanmar']",[],"['respiratory syncytial virus', 'CRP']","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003983', 'cui_str': 'South east Asian country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0006416', 'cui_str': 'Burma'}]",[],"[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",773.0,0.237316,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Althaus', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: thomas.a@tropmedres.ac.'}, {'ForeName': 'Janjira', 'Initials': 'J', 'LastName': 'Thaipadungpanit', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Greer', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Myo Maung Maung', 'Initials': 'MMM', 'LastName': 'Swe', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Dittrich', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.'}, {'ForeName': 'Pimnara', 'Initials': 'P', 'LastName': 'Peerawaranun', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pieter W', 'Initials': 'PW', 'LastName': 'Smit', 'Affiliation': 'Maasstad Ziekenhuis Hospital, Department of Medical Microbiology, Rotterdam, The Netherlands; Public Health Laboratory (GGD), Amsterdam, The Netherlands.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Blacksell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Winchell', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Maureen H', 'Initials': 'MH', 'LastName': 'Diaz', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smithuis', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Cambodia-Oxford Medical Research Unit (COMRU), Angkor Hospital for Children, Siem Reap, Cambodia.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.016']
1189,9001779,Long-term follow-up of endometriosis after two different therapies (Gestrinone and Buserelin).,"OBJECTIVE


To compare the efficacy, tolerance and recurrence rate of endometriosis after 5-year follow-up of treatment with Gestrinone and Buserelin, respectively.
STUDY DESIGN


A prospective study with randomized follow-up of 5 years duration (minimum) for each patient was done. We included 43 cases of endometriosis diagnosed by laparoscopy or laparotomy and treated them with Gestrinone (Group G, n = 25 cases) or Buserelin intranasal spray (Group B, n = 18) for 6 months.
RESULTS


General data: Age, height, weight of patients and AFS score of endometriosis were without significant differences in either group. Specific data: A) Global clinical efficacy was good or excellent in 74% (16/25) of group G and in 78% (14/18) of group B without significant differences. B) Global clinical tolerance was good in 50% of the patients in group G and in 0% in group B (p < 0.001). C) Global evaluation after 5-year follow-up showed ""success"" only for 36% of patients in group G and in 33% in group B (no significant differences), with ""failure"" in 40% and 33%, respectively (no significant differences).
CONCLUSIONS


1) Gestrinone and Buserelin intranasal spray are valid treatments for the remission of endometriosis, with ""success"", ""failure"" and ""clinical recurrence"" rates similar after a follow-up of 5 years of initial treatment. 2) The most significant androgenic effect of Gestrinone was the presence of acne. Vascular effects were also considered as very undesirable effects according to the comments of patients. On the contrary, the effects of analogs are generally better tolerated.",1996,"Global evaluation after 5-year follow-up showed ""success"" only for 36% of patients in group G and in 33% in group B (no significant differences), with ""failure"" in 40% and 33%, respectively (no significant differences).
","['43 cases of endometriosis diagnosed by laparoscopy or laparotomy and treated them with Gestrinone (Group G, n = 25 cases) or']","['therapies (Gestrinone and Buserelin', 'Buserelin intranasal spray', 'Gestrinone and Buserelin intranasal spray', 'Gestrinone and Buserelin', 'C']","['Global clinical tolerance', 'Global clinical efficacy', 'AFS score of endometriosis', 'efficacy, tolerance and recurrence rate of endometriosis', 'success', 'Vascular effects', 'failure']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441841', 'cui_str': 'Group G (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0017507', 'cui_str': 'Gestrinone'}, {'cui': 'C0006456', 'cui_str': 'Buserelin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.0418556,"Global evaluation after 5-year follow-up showed ""success"" only for 36% of patients in group G and in 33% in group B (no significant differences), with ""failure"" in 40% and 33%, respectively (no significant differences).
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nieto', 'Affiliation': 'Servicio de Obstetricía y Ginecología, Hospital Universitario Príncipe de Asturias.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tacuri', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Serra', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Keller', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cortés-Prieto', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1190,9478309,Tibolone in the treatment of psychosomatic symptoms in menopause.,"The purpose of this study was to investigate the value of tibolone in the treatment of psychosomatic symptoms in menopause. Forty-two menopausal women (aged 46-63, mean 53.9) with nightly perspiration, vasomotor flushes, disturbance of libido, dyspnea and other psychosomatic symptoms were assigned to one of two treatment groups for three months: 1st group) 21 users of tibolone; 2nd group) 21 users of placebo. At the end of the trial disturbance of libido was observed in 4 (19.0%) cases tin the 1st group and 11 (52.4%) cases in the 2nd (p < 0.05) and nightly perspiration was observed in 3 cases (14.3%) in the 1st group and 9 cases (42.9%) in the 2nd (p < 0.05). Although vasomotor flushes were observed in only 3 (14.3%) cases in the 1st group and 7 cases (33.3%) in the 2nd group, this difference was not significant (p > 0.05). There was no significant effect of tibolone or placebo in dyspnea, vertigo and headache. From the results it can be concluded that tibolone can have a beneficial effect on some psychosomatic symptoms in postmenopausal women.",1997,"Although vasomotor flushes were observed in only 3 (14.3%) cases in the 1st group and 7 cases (33.3%) in the 2nd group, this difference was not significant (p > 0.05).","['postmenopausal women', 'psychosomatic symptoms in menopause', 'Forty-two menopausal women (aged 46-63, mean 53.9) with nightly perspiration, vasomotor flushes, disturbance of libido, dyspnea and other psychosomatic symptoms']","['tibolone', 'placebo', 'Tibolone']","['trial disturbance of libido', 'dyspnea, vertigo and headache', 'vasomotor flushes', 'nightly perspiration']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]","[{'cui': 'C0076660', 'cui_str': 'tibolone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}]",42.0,0.0460856,"Although vasomotor flushes were observed in only 3 (14.3%) cases in the 1st group and 7 cases (33.3%) in the 2nd group, this difference was not significant (p > 0.05).","[{'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Argyroudis', 'Affiliation': 'Department of Obstetrics & Gynecology, Elena Venizelou Hospital, Athens, Greece.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Iatrakis', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kourkoubas', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Georgoulias', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kourounis', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tsionis', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Prapa', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Karamanos', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Diakakis', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Giannikos', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ladopoulos', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1191,31815653,Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): a randomised controlled open-label non-inferiority trial of duration of systemic antibiotics in adults with orthopaedic infection treated operatively with local antibiotic therapy.,"BACKGROUND


Orthopaedic infections, such as osteomyelitis, diabetic foot infection and prosthetic joint infection, are most commonly treated by a combination of surgical debridement and a prolonged course of systemic antibiotics, usually for at least 4-6 weeks. Use of local antibiotics, implanted directly into the site of infection at the time of surgery, may improve antibiotic delivery and allow us to shorten the duration of systemic antibiotic therapy, thereby limiting the frequency of side effects, cost and selection pressure for antimicrobial resistance.
METHODS


SOLARIO is a multicentre open-label randomised controlled non-inferiority trial comparing short and long systemic antibiotic therapy alongside local antibiotic therapy. Adult patients with orthopaedic infection, who have given informed consent, will be eligible to participate in the study provided that no micro-organisms identified from deep tissue samples are resistant to locally implanted antibiotics. Participants will be randomised in a 1:1 ratio to receive either a short course (≤ 7 days) or currently recommended long course (≥ 4 weeks) of systemic antibiotics. The primary outcome will be treatment failure by 12 months after surgery, as ascertained by an independent Endpoint Committee blinded to treatment allocation. An absolute non-inferiority margin of 10% will be used for both per-protocol and intention-to-treat populations. Secondary outcomes will include probable and definite treatment failure, serious adverse events, treatment side effects, quality of life scores and cost analysis.
DISCUSSION


This study aims to assess a treatment strategy that may enable the reduction of systemic antibiotic use for patients with orthopaedic infection. If this strategy is non-inferior, this will be to the advantage of patients and contribute to antimicrobial stewardship.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT03806166. Registered on 11 November 2019.",2019,"The primary outcome will be treatment failure by 12 months after surgery, as ascertained by an independent Endpoint Committee blinded to treatment allocation.","['adults with orthopaedic infection treated operatively with local antibiotic therapy', 'Adult patients with orthopaedic infection', 'Orthopaedics (SOLARIO', 'patients with orthopaedic infection']","['systemic antibiotic therapy alongside local antibiotic therapy', 'systemic antibiotics', 'short course (≤ 7\u2009days) or currently recommended long course (≥ 4\u2009weeks) of systemic antibiotics']","['probable and definite treatment failure, serious adverse events, treatment side effects, quality of life scores and cost analysis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0162643'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0010171', 'cui_str': 'Cost Analysis'}]",,0.347972,"The primary outcome will be treatment failure by 12 months after surgery, as ascertained by an independent Endpoint Committee blinded to treatment allocation.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dudareva', 'Affiliation': 'Bone Infection Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals, Oxford, UK. maria.dudareva@ouh.nhs.uk.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kümin', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Vach', 'Affiliation': 'Department of Orthopaedics and Traumatology, Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kaier', 'Affiliation': 'Institute of Medical Biometry and Medical Informatics, Universitätsklinikums Freiburg, Freiburg, Germany.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Ferguson', 'Affiliation': 'Bone Infection Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals, Oxford, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'McNally', 'Affiliation': 'Bone Infection Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals, Oxford, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Scarborough', 'Affiliation': 'Bone Infection Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals, Oxford, UK.'}]",Trials,['10.1186/s13063-019-3832-3']
1192,32243493,The fallacy of indexed effective orifice area charts to predict prosthesis-patient mismatch after prosthesis implantation.,"AIMS 


Indexed effective orifice area (EOAi) charts are used to determine the likelihood of prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR). The aim of this study is to validate whether these EOAi charts, based on echocardiographic normal reference values, can accurately predict PPM.
METHODS AND RESULTS 


In the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial, 986 patients with aortic valve stenosis/regurgitation underwent AVR with an Avalus valve. Patients were randomly split (50:50) into training and test sets. The mean measured EOAs for each valve size from the training set were used to create an Avalus EOAi chart. This chart was subsequently used to predict PPM in the test set and measures of diagnostic accuracy (sensitivity, specificity, and negative and positive predictive value) were assessed. PPM was defined by an EOAi ≤0.85 cm2/m2, and severe PPM was defined as EOAi ≤0.65 cm2/m2. The reference values obtained from the training set ranged from 1.27 cm2 for size 19 mm up to 1.81 cm2 for size 27 mm. The test set had an incidence of 66% of PPM and 24% of severe PPM. The EOAi chart inaccurately predicted PPM in 30% of patients and severe PPM in 22% of patients. For the prediction of PPM, the sensitivity was 87% and the specificity 37%. For the prediction of severe PPM, the sensitivity was 13% and the specificity 98%.
CONCLUSION 


The use of echocardiographic normal reference values for EOAi charts to predict PPM is unreliable due to the large proportion of misclassifications.",2020,The EOAi chart inaccurately predicted PPM in 30% of patients and severe PPM in 22% of patients.,"['prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR', '986 patients with aortic valve stenosis/regurgitation underwent AVR with an Avalus valve']",[],"['diagnostic accuracy (sensitivity, specificity, and negative and positive predictive value', 'PPM', 'severe PPM']","[{'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0449217', 'cui_str': 'aVR'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",986.0,0.0267809,The EOAi chart inaccurately predicted PPM in 30% of patients and severe PPM in 22% of patients.,"[{'ForeName': 'Michiel D', 'Initials': 'MD', 'LastName': 'Vriesendorp', 'Affiliation': 'Cardiothoracic Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'Rob A F De Lind', 'Initials': 'RAFL', 'LastName': 'Van Wijngaarden', 'Affiliation': 'Cardiothoracic Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, Netherlands.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Head', 'Affiliation': 'Global Clinical Operations, Coronary and Structural Heart, Medtronic, Endepolsdomein 5, 6229 GW, Maastricht, Netherlands.'}, {'ForeName': 'Arie-Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Global Clinical Operations, Coronary and Structural Heart, Medtronic, Endepolsdomein 5, 6229 GW, Maastricht, Netherlands.'}, {'ForeName': 'Graeme L', 'Initials': 'GL', 'LastName': 'Hickey', 'Affiliation': 'Global Clinical Operations, Coronary and Structural Heart, Medtronic, Endepolsdomein 5, 6229 GW, Maastricht, Netherlands.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Rao', 'Affiliation': 'Cardiovascular Surgery, Toronto General Hospital, 200 Elizabeth Street, Toronto, Ontario, Canada.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Weissman', 'Affiliation': 'Cardiovascular Core Laboratories, MedStar Health Research Institute, 6525 Belcrest Road, Suite 700, Hyattsville, MD 20782, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Cardiovascular Surgery, Houston Methodist Debakey Heart and Vascular Center, 6550 Fannin Street, Houston, TX 77030, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Moront', 'Affiliation': 'Cardiothoracic Surgery, ProMedica Toledo Hospital, 2109 Hughes Drive, Suite 720, Toledo, OH 43606, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Cardiac Surgery, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Lakeside 7, Cleveland, OH 44106-7060, USA.'}, {'ForeName': 'Robert J M', 'Initials': 'RJM', 'LastName': 'Klautz', 'Affiliation': 'Cardiothoracic Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, Netherlands.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jeaa044']
1193,31945149,Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study.,"The phase 3 ECHELON-1 study demonstrated that brentuximab vedotin (A) with doxorubicin, vinblastine, and dacarbazine (AVD; A+AVD) exhibited superior modified progression-free survival (PFS) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) for frontline treatment of patients with stage III/IV classical Hodgkin lymphoma (cHL). Maturing positron emission tomography (PET)-adapted trial data highlight potential limitations of PET-adapted approaches, including toxicities with dose intensification and higher-than-expected relapse rates in PET scan after cycle 2 (PET2)-negative (PET2-) patients. We present an update of the ECHELON-1 study, including an exploratory analysis of 3-year PFS per investigator. A total of 1334 patients with stage III or IV cHL were randomized 1:1 to receive 6 cycles of A+AVD (n = 664) or ABVD (n = 670). Interim PET2 was required. At median follow-up of 37 months, 3-year PFS rates were 83.1% with A+AVD and 76.0% with ABVD; 3-year PFS rates in PET2- patients aged <60 years were 87.2% vs 81.0%, respectively. A beneficial trend in PET2+ patients aged <60 years on A+AVD was also observed, with a 3-year PFS rate of 69.2% vs 54.7% with ABVD. The benefit of A+AVD in the intent-to-treat population appeared independent of disease stage and prognostic risk factors. Upon continued follow-up, 78% of patients with peripheral neuropathy on A+AVD had either complete resolution or improvement compared with 83% on ABVD. These data highlight that A+AVD provides a durable efficacy benefit compared with ABVD for frontline stage III/IV cHL, consistent across key subgroups regardless of patient status at PET2, without need for treatment intensification or bleomycin exposure. This trial was registered at www.clinicaltrials.gov as #NCT01712490 (EudraCT no. 2011-005450-60).",2020,"At a median follow-up of 37 months, 3-year PFS rates were 83.1% with A+AVD and 76.0% with ABVD; 3-year PFS rates in PET2(-) patients aged <60 years were 87.2% versus 81.0%, respectively.","['1334 patients with stage III or IV cHL', 'Stage III/IV classical Hodgkin lymphoma', 'patients with stage III/IV classical Hodgkin lymphoma (cHL) (NCT01712490; 2011-005450-60']","['A+AVD', 'bleomycin', 'ABVD', 'brentuximab vedotin (A) with AVD (A+AVD) exhibited superior modified PFS versus ABVD', 'Brentuximab vedotin with chemotherapy']","['PFS rates', '3-year PFS rate', '3-year PFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}]","[{'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1334.0,0.136096,"At a median follow-up of 37 months, 3-year PFS rates were 83.1% with A+AVD and 76.0% with ABVD; 3-year PFS rates in PET2(-) patients aged <60 years were 87.2% versus 81.0%, respectively.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Straus', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Długosz-Danecka', 'Affiliation': 'Department of Hematology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Alekseev', 'Affiliation': 'N. N. Petrov Scientific Research Institute of Oncology, St. Petersburg, Russian Federation.'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Illés', 'Affiliation': 'Department of Hematology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Picardi', 'Affiliation': 'Department of Advanced Biomedical Science, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Lech-Maranda', 'Affiliation': 'Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Smolewski', 'Affiliation': 'Department of Experimental Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Savage', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Division of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Walewski', 'Affiliation': 'Department of Lymphoid Malignancy, The Maria Sklodowska-Curie Memorial Institute and Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Ramchandren', 'Affiliation': 'Department of Medicine, Graduate School of Medicine, The University of Tennessee, Knoxville, TN.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology Seragnoli, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hutchings', 'Affiliation': 'Department of Hematology, Finsen Centre, National Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Radford', 'Affiliation': 'Department of Medical Oncology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Munoz', 'Affiliation': 'Department of Lymphoma/Myeloma, Banner MD Anderson Cancer Center, Gilbert, AZ.'}, {'ForeName': 'Won Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Ranjana', 'Initials': 'R', 'LastName': 'Advani', 'Affiliation': 'Department of Medicine/Oncology, Stanford Cancer Institute, Stanford, CA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Younes', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Millennium Pharmaceuticals, Inc, Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceuticals Company Limited.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Millennium Pharmaceuticals, Inc, Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceuticals Company Limited.'}, {'ForeName': 'Keenan', 'Initials': 'K', 'LastName': 'Fenton', 'Affiliation': 'Seattle Genetics, Inc, Bothell, WA; and.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'Seattle Genetics, Inc, Bothell, WA; and.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gallamini', 'Affiliation': 'Research and Clinical Innovation, Antoine-Lacassagne Cancer Centre, Nice, France.'}]",Blood,['10.1182/blood.2019003127']
1194,7042126,Use of topical benzydamine in gynecology.,"To evaluate the topical anti-inflammatory activity of benzydamine when used as 0.1% solution for vaginal douche, a double blind, parallel group, randomized clinical trial was carried out on 30 patients with vaginitis following internal radiotherapy for carcinoma of the uterus. The patients were divided into 3 groups, one being treated with 0.1% benzydamine plus tricetol as preservative, one with 0.1% benzydamine alone, and one with placebo. Treatment began 12-24 hours after radiotherapy. Benzydamine was found to be significantly superior to placebo in its overall topical anti-inflammatory activity both after 5 and 15 days of treatment. Tricetol did not interfere with the therapeutic effect of benzydamine.",1981,Benzydamine was found to be significantly superior to placebo in its overall topical anti-inflammatory activity both after 5 and 15 days of treatment.,"['30 patients with vaginitis following internal radiotherapy for carcinoma of the uterus', 'gynecology']","['placebo', 'topical benzydamine', 'benzydamine plus tricetol as preservative, one with 0.1% benzydamine alone, and one with placebo', 'benzydamine', 'Benzydamine']",['overall topical anti-inflammatory activity'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042267', 'cui_str': 'Vaginitis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0555352', 'cui_str': 'Internal radiotherapy'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0042149', 'cui_str': 'Womb'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0005099', 'cui_str': 'Benzydamine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",30.0,0.0382224,Benzydamine was found to be significantly superior to placebo in its overall topical anti-inflammatory activity both after 5 and 15 days of treatment.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bentivoglio', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Diani', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1195,31298632,Effects of E-cigarette Advertising Message Form and Cues on Cessation Intention: An Exploratory Study.,"A common message in e-cigarette advertising is that e-cigarettes can be used anywhere. E-cigarette advertisements often express this message implicitly (e.g., ""Whenever, wherever"") alongside images of e-cigarettes that physically resemble combustible cigarettes. These implicit messages and ""cigalike"" images may cross-cue combustible cigarette smoking cognitions and behavior. This exploratory study was a 2 (message form: implicit or explicit e-cigarette use anywhere message) by 2 (presence or absence of e-cigarette cue) experiment with U.S. adult smokers (n = 2,201). Participants were randomized to view e-cigarette advertisements that varied by study condition. Three combustible cigarette outcomes were investigated: smoking cessation intention, smoking urges, and immediate smoking behavior. Mediation analysis was also performed to investigate mechanisms of the message form effect through descriptive and normative beliefs about smoking. Compared to its explicit counterpart, the implicit e-cigarette use anywhere message evoked greater smoking urges. Participants exposed to the implicit message also perceived cigarette smoking to be more prevalent and, in turn, reported greater cessation intention. There was no evidence of e-cigarette cue or message form × cue interaction effects. Implicit e-cigarette use anywhere messages may create a predisposition towards smoking compared to their explicitly written counterparts, but whether this effect undermines cessation deserves further attention.",2019,"Participants exposed to the implicit message also perceived cigarette smoking to be more prevalent and, in turn, reported greater cessation intention.",[],['E-cigarette Advertising Message Form and Cues'],"['smoking cessation intention, smoking urges, and immediate smoking behavior', 'Cessation Intention']",[],"[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}]",,0.012925,"Participants exposed to the implicit message also perceived cigarette smoking to be more prevalent and, in turn, reported greater cessation intention.","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Jo', 'Affiliation': 'a Gillings School of Global Public Health, University of North Carolina , Chapel Hill , North Carolina , USA.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'b School of Media and Journalism, University of North Carolina , Chapel Hill , North Carolina , USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Southwell', 'Affiliation': 'a Gillings School of Global Public Health, University of North Carolina , Chapel Hill , North Carolina , USA.'}, {'ForeName': 'Kurt M', 'Initials': 'KM', 'LastName': 'Ribisl', 'Affiliation': 'a Gillings School of Global Public Health, University of North Carolina , Chapel Hill , North Carolina , USA.'}]",Journal of health communication,['10.1080/10810730.2019.1639857']
1196,6370504,Oxybutynin chloride in the treatment of female idiopathic bladder instability. Results from double blind treatment.,"The Authors carried out a random double-blind trial on 30 patients affected by idiopathic urge incontinence with oxybutynin chloride (15 mg/die) and placebo for two 20 day therapeutical cycles. The 24 patients who completed the trial oxybutynin chloride induced statistically significant effects--compared to placebo too--both on the subjective symptoms (reduction or disappearance of the urgency in 14 cases - 60.8% - and of urge incontinence in 16 cases - 76.1%) and on the objective symptoms showed by cystomanometry (increased bladder capacity at the FD and VSD in 14 and 15 cases, respectively; absence of involuntary contraction in 9 cases and normal or reduced detrusor pressure at the VSD in 13 out of 16 cases). Improvements, though less significant, were also obtained with the placebo.",1984,"The 24 patients who completed the trial oxybutynin chloride induced statistically significant effects--compared to placebo too--both on the subjective symptoms (reduction or disappearance of the urgency in 14 cases - 60.8% - and of urge incontinence in 16 cases - 76.1%) and on the objective symptoms showed by cystomanometry (increased bladder capacity at the FD and VSD in 14 and 15 cases, respectively; absence of involuntary contraction in 9 cases and normal or reduced detrusor pressure at the VSD in 13 out of 16 cases).","['30 patients affected by idiopathic urge incontinence with oxybutynin chloride (15 mg/die) and placebo for two 20 day therapeutical cycles', 'female idiopathic bladder instability']","['placebo', 'Oxybutynin chloride']","['urge incontinence', 'subjective symptoms (reduction or disappearance of the urgency', 'detrusor pressure', 'bladder capacity']","[{'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0150045', 'cui_str': 'Urinary Reflex Incontinence'}, {'cui': 'C0134394', 'cui_str': 'Oxybutynin chloride'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2945586', 'cui_str': 'Bladder irritability (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0134394', 'cui_str': 'Oxybutynin chloride'}]","[{'cui': 'C0150045', 'cui_str': 'Urinary Reflex Incontinence'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0429766', 'cui_str': 'Detrusor pressure (observable entity)'}, {'cui': 'C0429807', 'cui_str': 'Bladder capacity (observable entity)'}]",30.0,0.18979,"The 24 patients who completed the trial oxybutynin chloride induced statistically significant effects--compared to placebo too--both on the subjective symptoms (reduction or disappearance of the urgency in 14 cases - 60.8% - and of urge incontinence in 16 cases - 76.1%) and on the objective symptoms showed by cystomanometry (increased bladder capacity at the FD and VSD in 14 and 15 cases, respectively; absence of involuntary contraction in 9 cases and normal or reduced detrusor pressure at the VSD in 13 out of 16 cases).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Riva', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Casolati', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1197,32139312,Clinical predictors of blood pressure response after renal artery stenting.,"OBJECTIVE


The Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial, a multicenter randomized controlled trial, failed to demonstrate a benefit of renal artery stenting (RAS) over medical therapy in patients with renal artery stenosis and hypertension. However, there are patients for whom RAS is a consideration because of failure of medical therapy. Unfortunately, selection of patients for RAS is complicated by a lack of validated predictors of blood pressure (BP) response. A previous single-center study identified three preoperative markers of BP response to RAS: requirement for four or more antihypertensive medications, preoperative diastolic BP >90 mm Hg, and preoperative clonidine use. To date, these markers of outcome have not been independently validated. The aim of this study was to validate these markers using data from the CORAL trial.
METHODS


All patients randomized in the CORAL trial to RAS were included. American Heart Association guidelines were used to categorize patients as BP responders or nonresponders to RAS. BP responders were defined by a postoperative BP <160/90 mm Hg with a reduced number of antihypertensive medications or a reduction in diastolic BP to <90 mm Hg with the same medications after RAS. Patients with stable or worsened BP were labeled nonresponders. Variables associated with a favorable BP response were identified by multivariable logistic regression analysis.
RESULTS


There were 436 patients who underwent RAS with a median age of 70 years (interquartile range [IQR], 63-76 years). The median systolic and diastolic BPs of the stented cohort at baseline were 149 mm Hg (IQR, 132-164 mm Hg) and 78 mm Hg (IQR, 70-87 mm Hg), respectively. A positive BP response occurred in 284 of 436 (65.1%) stented patients. Multivariable logistic regression analysis identified three independent markers of a positive BP response: requirement for four or more medications (odds ratio, 5.9; P < .001), preoperative diastolic BP >90 mm Hg (odds ratio 13.9; P < .001), and preoperative clonidine use (odds ratio, 4.52; P = .008). The percentage of patients with a positive BP response increased incrementally as the number of markers per patient increased, based on the Cochran-Armitage test for trend (P < .0001).
CONCLUSIONS


In patients from the CORAL trial who underwent RAS, the previously reported clinical markers of BP response were validated. A prospective trial to validate their utility as predictors of BP response to RAS is warranted.",2020,"90 mm Hg (odds ratio 13.9; P < .001), and preoperative clonidine use (odds ratio, 4.52; P = .008).","['renal artery stenting', 'All patients randomized in the CORAL trial to RAS were included', '436 patients who underwent RAS with a median age of 70\xa0years (interquartile range [IQR], 63-76\xa0years', 'Renal Atherosclerotic Lesions (CORAL', 'patients with renal artery stenosis and hypertension']",['renal artery stenting (RAS'],"['clinical markers of BP response', 'BP responders', 'preoperative diastolic BP ', 'blood pressure (BP) response', 'diastolic BP to', 'positive BP response', 'postoperative BP', 'blood pressure response', 'median systolic and diastolic BPs', 'favorable BP response']","[{'cui': 'C0035065', 'cui_str': 'Renal Artery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0324034', 'cui_str': 'Coral'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0035067', 'cui_str': 'Renal Artery Stenosis'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0035065', 'cui_str': 'Renal Artery'}]","[{'cui': 'C0008963', 'cui_str': 'Markers, Clinical'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response (observable entity)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",436.0,0.110255,"90 mm Hg (odds ratio 13.9; P < .001), and preoperative clonidine use (odds ratio, 4.52; P = .008).","[{'ForeName': 'J Gregory', 'Initials': 'JG', 'LastName': 'Modrall', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, University of Texas Southwestern Medical Center, Dallas, Tex; Surgical Service, Dallas Veterans Affairs Medical Center, Dallas, Tex. Electronic address: greg.modrall@utsouthwestern.edu.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Tex.'}, {'ForeName': 'Fred A', 'Initials': 'FA', 'LastName': 'Weaver', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Department of Surgery, Keck School of Medicine at the University of Southern California, Los Angeles, Calif.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.12.041']
1198,6762263,Sulpiride isomers and milk secretion in puerperium.,"The effect of oral administration of sulpiride isomers on PRL secretion and breast engorgement was studied in 60 multiparous nursing mothers, according to a double blind schedule: 45 women were orally given 50 mg sulpiride (L, D, L-D form) twice daily during the first 5 days of puerperium, 15 were given a placebo in the same way. Basal, the 3rd and 5th day serum PRL levels were determined and every day milk secretion was evaluated. On milk samples obtained on the 5th day, sulpiride concentration was measured. 40 women with insufficient lactation and 20 with total lack of milk, 25-40 days after delivery, were treated in the same way, in double blind. Milk secretion was evaluated at the beginning and at the 5th, 10th and 15th day. The mean total milk yield (+/- S.D.) during the first 5 postpartum days in sulpiride groups were significantly greater than that in the control group. Plasma PRL levels resulted significantly higher in sulpiride treated groups than in placebo group. All women with insufficient or absent milk secretion could avoid supplemental bottle-feeding after 10 days of treatment.",1982,Plasma PRL levels resulted significantly higher in sulpiride treated groups than in placebo group.,"['puerperium', '40 women with insufficient lactation and 20 with total lack of milk, 25-40 days after delivery', '60 multiparous nursing mothers']","['placebo', 'sulpiride isomers']","['mean total milk yield', 'sulpiride concentration', 'serum PRL levels', 'Milk secretion', 'PRL secretion and breast engorgement', 'Plasma PRL levels']","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020610', 'cui_str': 'Hypogalactia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026751', 'cui_str': 'Multiparity'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0085688', 'cui_str': 'Milk engorgement of breast (disorder)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",40.0,0.0381168,Plasma PRL levels resulted significantly higher in sulpiride treated groups than in placebo group.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Polatti', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1199,31558730,Network-based Responses to the Psychomotor Vigilance Task during Lapses in Adolescents after Short and Extended Sleep.,"Neuroimaging studies of the Psychomotor Vigilance Task (PVT) have revealed brain regions involved in attention lapses in sleep-deprived and well-rested adults. Those studies have focused on individual brain regions, rather than integrated brain networks, and have overlooked adolescence, a period of ongoing brain development and endemic short sleep. This study used functional MRI (fMRI) and a contemporary analytic approach to assess time-resolved peri-stimulus response of key brain networks when adolescents complete the PVT, and test for differences across attentive versus inattentive periods and after short sleep versus well-rested states. Healthy 14-17-year-olds underwent a within-subjects randomized protocol including 5-night spans of extended versus short sleep. PVT was performed during fMRI the morning after each sleep condition. Event-related independent component analysis (eICA) identified coactivating functional networks and corresponding time courses. Analysis of salient time course characteristics tested the effects of sleep condition, lapses, and their interaction. Seven eICA networks were identified supporting attention, executive control, motor, visual, and default-mode functions. Attention lapses, after either sleep manipulation, were accompanied by broadly increased response magnitudes post-stimulus and delayed peak responses in some networks. Well-circumscribed networks respond during the PVT in adolescents, with timing and intensity impacted by attentional lapses regardless of experimentally shortened or extended sleep.",2019,"Attention lapses, after either sleep manipulation, were accompanied by broadly increased response magnitudes post-stimulus and delayed peak responses in some networks.","['Healthy 14-17-year-olds', 'Adolescents after Short and Extended Sleep']","['functional MRI (fMRI', 'PVT', '5-night spans of extended versus short sleep', 'Psychomotor Vigilance Task (PVT']","['sleep condition, lapses, and their interaction']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",,0.0320693,"Attention lapses, after either sleep manipulation, were accompanied by broadly increased response magnitudes post-stimulus and delayed peak responses in some networks.","[{'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'DiFrancesco', 'Affiliation': ""Pediatric Neuroimaging Research Consortium, Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. mark.difrancesco@cchmc.org.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Van Dyk', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Altaye', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'S P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'Monash Institute for Cognitive and Clinical Neuroscience, School of Psychological Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': 'College of Medicine, University of Cincinnati, Cincinnati, OH, USA.'}]",Scientific reports,['10.1038/s41598-019-50180-6']
1200,31558733,Oxytocin modulates the temporal dynamics of resting EEG networks.,"Oxytocin is a key modulator of social interaction, but we possess little knowledge of its underlying effects on neuropsychological processes. We used a spatio-temporal EEG microstates analysis to reveal oxytocin's effects on the temporal dynamics of intrinsically generated activity in neural networks. Given oxytocin's known anxiolytic effects, we hypothesized that it increases the temporal stability of the four archetypal EEG resting networks. Eighty-six male participants had received oxytocin or placebo intranasally before we recorded their resting EEG. As hypothesized, oxytocin globally increased the average duration of the four archetypal resting networks and specifically decreased the occurrence and coverage of an autonomic processing-related network to benefit greater coverage of an attention-related network. Moreover, these neurophysiological changes were more pronounced in participants with high anxiety levels and strong subjectively experienced effects of the oxytocin administration. In sum, our study shows that oxytocin reduces rapid switching among neural resting networks by increasing their temporal stability. Specifically, it seems to reduce the brain's need for preparing the internally-oriented processing of autonomic information, thus enabling the externally-oriented processing of social information. Changes in the temporal dynamics of resting networks might underlie oxytocin's anxiolytic effects - potentially informing innovative psychobiological treatment strategies.",2019,"As hypothesized, oxytocin globally increased the average duration of the four archetypal resting networks and specifically decreased the occurrence and coverage of an autonomic processing-related network to benefit greater coverage of an attention-related network.",['Eighty-six male participants'],"['oxytocin', 'Oxytocin', 'oxytocin or placebo']",[],"[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],86.0,0.0817619,"As hypothesized, oxytocin globally increased the average duration of the four archetypal resting networks and specifically decreased the occurrence and coverage of an autonomic processing-related network to benefit greater coverage of an attention-related network.","[{'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Schiller', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, DE-79104, Freiburg, Germany. schiller@psychologie.uni-freiburg.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Koenig', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, CH-3000, Bern, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, DE-79104, Freiburg, Germany. heinrichs@psychologie.uni-freiburg.de.'}]",Scientific reports,['10.1038/s41598-019-49636-6']
1201,32150263,Reducing the initial number of rituximab maintenance-therapy infusions for ANCA-associated vasculitides: randomized-trial post-hoc analysis.,"OBJECTIVE


The randomized, controlled MAINRITSAN2 trial was designed to compare the capacity of an individually tailored therapy [randomization day 0 (D0)], with reinfusion only when CD19+ lymphocytes or ANCA had reappeared, or if the latter's titre rose markedly, with that of five fixed-schedule 500-mg rituximab infusions [D0 + D14, then months (M) 6, 12 and 18] to maintain ANCA-associated vasculitis (AAV) remissions. Relapse rates did not differ at M28. This ancillary study was undertaken to evaluate the effect of omitting the D14 rituximab infusion on AAV relapse rates at M12.
METHODS


MAINRITSAN2 trial data were subjected to post-hoc analyses of M3, M6, M9 and M12 relapse-free survival rates in each arm as primary end points. Exploratory subgroup analyses were run according to CYC or rituximab induction and newly diagnosed or relapsing AAV.
RESULTS


At M3, M6, M9 and M12, respectively, among the 161 patients included, 79/80 (98.8%), 76/80 (95%), 74/80 (92.5%) and 73/80 (91.3%) from D0, and 80/81 (98.8%), 78/81 (96.3%), 76/81 (93.8%) and 76/81 (93.8%) from D0+D14 groups were alive and relapse-free. No between-group differences were observed. Results were not affected by CYC or rituximab induction, or newly diagnosed or relapsing AAV.
CONCLUSIONS


We were not able to detect a difference between the relapse-free survival rates for up to M12 for the D0 and D0+D14 rituximab-infusion groups, which could suggest that omitting the D14 rituximab remission-maintenance dose did not modify the short-term relapse-free rate. Nevertheless, results at M12 may also have been influenced by the rituximab-infusion strategies for both groups.",2020,"We were not able to detect a difference between the relapse-free survival rates for up to M12 for the D0 and D0+D14 rituximab-infusion groups, which could suggest that omitting the D14 rituximab remission-maintenance dose did not modify the short-term relapse-free rate.",[],[],"['relapse-free survival rates', 'Relapse rates', 'alive and relapse-free', 'M3, M6, M9 and M12 relapse-free survival rates', 'AAV relapse rates']",[],[],"[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2584946', 'cui_str': 'Alive'}]",161.0,0.07582,"We were not able to detect a difference between the relapse-free survival rates for up to M12 for the D0 and D0+D14 rituximab-infusion groups, which could suggest that omitting the D14 rituximab remission-maintenance dose did not modify the short-term relapse-free rate.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Charles', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Dechartres', 'Affiliation': ""Sorbonne Universitù, Institut National de la Santù et de la Recherche Médicale (INSERM), Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP. Sorbonne Université, Hôpital Pitié Salpêtriére, Département de SantÕ Publique, Paris.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Terrier', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Cohen', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Faguer', 'Affiliation': ""Département de Néphrologie et Transplantation d'Organes, Centre Hospitalier Universitaire (CHU) de Toulouse, Toulouse.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Huart', 'Affiliation': ""Département de Néphrologie et Transplantation d'Organes, Centre Hospitalier Universitaire (CHU) de Toulouse, Toulouse.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamidou', 'Affiliation': 'Service de Médecine Interne, Hôtel-Dieu, CHU, Nantes.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Agard', 'Affiliation': 'Service de Médecine Interne, Hôtel-Dieu, CHU, Nantes.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Bonnotte', 'Affiliation': 'Service de Médecine Interne et Immunologie Clinique, CHU de Dijon, INSERM, UMR 1098, Université de Bourgogne Franche-Comté, FHU INCREASE, Dijon.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Samson', 'Affiliation': 'Service de Médecine Interne et Immunologie Clinique, CHU de Dijon, INSERM, UMR 1098, Université de Bourgogne Franche-Comté, FHU INCREASE, Dijon.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Karras', 'Affiliation': 'Centre de Néphrologie et de Transplantation Rénale, Unité de Néphrologie, APHP, Hôpital Européen Georges-Pompidou, Université Paris Descartes, Paris.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Jourde-Chiche', 'Affiliation': 'Aix-Marseille Université, Centre de Néphrologie et de Transplantation Rénale, AP-HM, Hôpital de la Conception, Marseille.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lifermann', 'Affiliation': 'Service de Médecine Interne Hématologie, CH de Dax, Dax.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gobert', 'Affiliation': 'Hôpital Général Henri-Duffaut, Avignon.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hanrotel-Saliou', 'Affiliation': 'Service de Néphrologie, Dialyse et Transplantation Rénale, Hôpital la Cavale Blanche, CH Régionale Universitaire Brest, Brest.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Godmer', 'Affiliation': 'Département de Médecine Interne, CH Bretagne Atlantique de Vannes, Vannes.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Martin-Silva', 'Affiliation': 'Unité de Médecine Interne, CHU de Caen, Caen.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Pugnet', 'Affiliation': 'Service de Médecine Interne, CHU de Toulouse, Toulouse.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Matignon', 'Affiliation': 'Service de Néphrologie, APHP, CHU Henri-Mondor, Créteil.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Aumaitre', 'Affiliation': 'Service de Médecine Interne, CHU, Hôpital Gabriel-Montpied, Clermont-Ferrand.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Viallard', 'Affiliation': 'Service de Médecine Interne et Maladies Infectieuses, CHU de Bordeaux, Pessac.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maurier', 'Affiliation': 'Service de Médecine Interne, Hôpitaux Privés de Metz, Metz.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Meaux-Ruault', 'Affiliation': 'Service de Médecine Interne, CHU Jean-Minjoz, Besançon.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Rivière', 'Affiliation': 'Service de Médecine Interne, CHU de Montpellier, Montpellier.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Service de Rhumatologie, Hôpital de Hautepierre, CHU de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Puéchal', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Mouthon', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Guillevin', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez621']
1202,31922456,Evaluating approaches to marketing cognitive behavioral therapy: does evidence matter to consumers?,"Direct-to-consumer marketing initiatives may improve utilization of evidence-based therapy.  An important decision in such marketing efforts is how to effectively present scientific evidence supporting these treatments to potential consumers (if at all). This OSF preregistered study experimentally tested whether the language used to describe research evidence supporting cognitive behavioral therapy (CBT) for anxiety disorders affected consumer treatment attitudes and intentions. Adult participants (N = 303) recruited via mTurk were first assessed for their understanding of the term ""evidence-based."" They were then randomized to read a description of CBT employing either: formal research language (e.g., ""large-scale clinical trials have demonstrated…""), informal language about research support derived from prior qualitative work (e.g., ""people have better results…""), or no information about research. Perceptions of CBT (including credibility and expectancy) and likelihood of pursuing CBT (pull demand) were assessed. Results indicated that only half the sample understood the meaning of the term ""evidence-based."" The conditions that discussed research support outperformed the control condition on CBT perceptions, credibility, general expectancies, and perceived effectiveness. Post-hoc comparisons provided some evidence that qualitatively-derived language was more effective than formal research language for promoting positive perceptions of CBT. Implications for marketing content are discussed.",2020,Post-hoc comparisons provided some evidence that qualitatively-derived language was more effective than formal research language for promoting positive perceptions of CBT.,"['Adult participants (N = 303) recruited via mTurk were first assessed for their understanding of the term ""evidence-based']","['cognitive behavioral therapy (CBT', 'marketing cognitive behavioral therapy']","['Perceptions of CBT (including credibility and expectancy) and likelihood of pursuing CBT (pull demand', 'CBT perceptions, credibility, general expectancies, and perceived effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0451564,Post-hoc comparisons provided some evidence that qualitatively-derived language was more effective than formal research language for promoting positive perceptions of CBT.,"[{'ForeName': 'Casey A', 'Initials': 'CA', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychology, Skidmore College , Saratoga Springs, NY, USA.'}, {'ForeName': 'Gabriella T', 'Initials': 'GT', 'LastName': 'Ponzini', 'Affiliation': 'Department of Psychology, West Virginia University , Morgantown, WV, USA.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Becker', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University School of Public Health , Providence, RI, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2019.1682654']
1203,6370503,Induction of labour using prostaglandin E2 pessaries.,"199 patients were used in a double blind placebo controlled trial testing the efficacy of prostaglandin E2 3 mg pessaries in the induction of labour. The trial showed that prostaglandin E2 pessaries were effective in the induction of labour but that with only a 55% success rate the results were less than that quoted by others. It was felt that the success rate could be increased by either reducing the time interval between insertion of the pessaries or by using a slow release vehicle for the prostaglandin. Surprisingly no significant shortening in the duration of labour was found between the prostaglandin group and the placebo group, despite a significant increase in the favourability of the cervix in the prostaglandin pessary group. Also no factors were found which definitely distinguished between the success or failure of induction of labour using prostaglandin pessaries. It was felt that prostaglandin pessaries were a safe and reasonably effective method of induction of labour and that, with reduction in the time interval between insertion of pessaries or the use of a slow release vehicle for the prostaglandin, the efficacy would be greatly increased.",1984,"Surprisingly no significant shortening in the duration of labour was found between the prostaglandin group and the placebo group, despite a significant increase in the favourability of the cervix in the prostaglandin pessary group.",['199 patients'],"['placebo', 'prostaglandin E2 3 mg pessaries', 'prostaglandin pessaries', 'prostaglandin', 'prostaglandin E2 pessaries']","['favourability of the cervix', 'success rate', 'duration of labour', 'induction of labour', 'success or failure of induction of labour']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0031246', 'cui_str': 'Pessaries'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}]","[{'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor (observable entity)'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",199.0,0.0504008,"Surprisingly no significant shortening in the duration of labour was found between the prostaglandin group and the placebo group, despite a significant increase in the favourability of the cervix in the prostaglandin pessary group.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Campbell', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1204,32228880,Consistency and objectivity of automated embryo assessments using deep neural networks.,"OBJECTIVE


To evaluate the consistency and objectivity of deep neural networks in embryo scoring and making disposition decisions for biopsy and cryopreservation in comparison to grading by highly trained embryologists.
DESIGN


Prospective double-blind study using retrospective data.
SETTING


U.S.-based large academic fertility center.
PATIENTS


Not applicable.
INTERVENTION(S)


Embryo images (748 recorded at 70 hours postinsemination [hpi]) and 742 at 113 hpi) were used to evaluate embryologists and neural networks in embryo grading. The performance of 10 embryologists and a neural network were also evaluated in disposition decision making using 56 embryos.
MAIN OUTCOME MEASURES


Coefficients of variation (%CV) and measures of consistencies were compared.
RESULTS


Embryologists exhibited a high degree of variability (%CV averages: 82.84% for 70 hpi and 44.98% for 113 hpi) in grading embryo. When selecting blastocysts for biopsy or cryopreservation, embryologists had an average consistency of 52.14% and 57.68%, respectively. The neural network outperformed the embryologists in selecting blastocysts for biopsy and cryopreservation with a consistency of 83.92%. Cronbach's α analysis revealed an α coefficient of 0.60 for the embryologists and 1.00 for the network.
CONCLUSIONS


The results of our study show a high degree of interembryologist and intraembryologist variability in scoring embryos, likely due to the subjective nature of traditional morphology grading. This may ultimately lead to less precise disposition decisions and discarding of viable embryos. The application of a deep neural network, as shown in our study, can introduce improved reliability and high consistency during the process of embryo selection and disposition, potentially improving outcomes in an embryology laboratory.",2020,The neural network outperformed the embryologists in selecting blastocysts for biopsy and cryopreservation with a consistency of 83.92%.,"['Not applicable', 'U.S.-based large academic fertility center']",[],['Coefficients of variation (%CV) and measures of consistencies'],"[{'cui': 'C1272460', 'cui_str': 'Not applicable (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",[],"[{'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",,0.0666955,The neural network outperformed the embryologists in selecting blastocysts for biopsy and cryopreservation with a consistency of 83.92%.,"[{'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Bormann', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Prudhvi', 'Initials': 'P', 'LastName': 'Thirumalaraju', 'Affiliation': ""Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Kanakasabapathy', 'Affiliation': ""Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Hemanth', 'Initials': 'H', 'LastName': 'Kandula', 'Affiliation': ""Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Souter', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Dimitriadis', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Raghav', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': ""Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Pooniwala', 'Affiliation': ""Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Shafiee', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Department of Medicine, Harvard Medical School, Boston, Massachusetts. Electronic address: hshafiee@bwh.harvard.edu.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.12.004']
1205,31398441,Cardiac autonomic activity during sleep deprivation with and without caffeine administration.,"Caffeine is often consumed to mitigate degraded alertness associated with sleep deprivation. Both caffeine and sleep deprivation have been implicated in cardiovascular disease, but evidence is largely anecdotal. We determined the effects of sleep deprivation and caffeine on markers of cardiac autonomic activity. Twelve healthy young adults completed an 18-day laboratory study. They were exposed to three 48 h sessions of acute total sleep deprivation (TSD), each separated by three recovery days. In randomized, counter-balanced order, subjects received 0 mg (placebo), 200 mg, or 300 mg of caffeine at 12 h intervals during each sleep deprivation session. Every 2 h during scheduled wakefulness, a 15-minute neurobehavioral task battery was administered, during which heart rate (HR) and the high frequency (HF) component of the HR variability power spectrum (HF-HRV) were measured. Caffeine administration decreased HR and increased HF-HRV, indicating elevated parasympathetic activity. The 300 mg caffeine dose did not significantly affect autonomic activity to a greater extent than the 200 mg dose. There was no significant effect of 48 h of TSD on HR, whereas there was a small increase across hours awake in HF-HRV. There was no significant interaction of TSD with caffeine. Circadian rhythmicity in HR and HF-HRV surpassed the magnitude of the effects of caffeine and TSD. Caffeine and acute TSD thus produced only modest changes in cardiac autonomic activity, unlikely to have immediate clinical implications in healthy young adults. However, further research is needed to determine the long-term effects of chronic exposure to sleep loss and/or caffeine on cardiac health, and to determine the generalizability of our findings to non-healthy populations.",2019,The 300 mg caffeine dose did not significantly affect autonomic activity to a greater extent than the 200 mg dose.,"['healthy young adults', 'Twelve healthy young adults completed an 18-day laboratory study']","['caffeine', 'mg (placebo', 'Caffeine']","['acute total sleep deprivation (TSD', 'autonomic activity', 'elevated parasympathetic activity', 'Cardiac autonomic activity', 'cardiac autonomic activity', 'HR and increased HF-HRV']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0039373', 'cui_str': 'Hexosaminidase A Deficiency Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",12.0,0.055929,The 300 mg caffeine dose did not significantly affect autonomic activity to a greater extent than the 200 mg dose.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Crooks', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Department of Physical Therapy, Eastern Washington University, 310 N. Riverpoint Blvd., Spokane, WA 99202-0002, USA. Electronic address: ecrooks@ewu.edu.'}, {'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Hansen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA. Electronic address: devon.hansen@wsu.edu.'}, {'ForeName': 'Brieann C', 'Initials': 'BC', 'LastName': 'Satterfield', 'Affiliation': 'Social, Cognitive, and Affective Neuroscience Lab, University of Arizona College of Medicine, PO Box 245002, Tucson, AZ 85724-5002, USA. Electronic address: bsatterfield@psychiatry.arizona.edu.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Layton', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA. Electronic address: layton@wsu.edu.'}, {'ForeName': 'Hans P A', 'Initials': 'HPA', 'LastName': 'Van Dongen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA. Electronic address: hvd@wsu.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112643']
1206,6437699,Treatment of IUD related menorrhagia by indomethacin.,"Indomethacin, prostaglandin synthetase inhibitor was tested in 9 women wearing a lippes loop IUD. These women suffered from excessive bleeding with a mean menstrual blood loss of more than 100 ml. The effect was studied by quantifying menstrual blood loss in a double blind 4 periods crossover study. The mean percentage reduction during treatment was of 57 percent. No significant placebo effect was observed. The effect of indomethacin support the contention that IUD's associated menorrhagia, is connected to an abnormal prostaglandin synthetase in the endometrium.",1984,No significant placebo effect was observed.,['9 women wearing a lippes loop IUD'],"['Indomethacin, prostaglandin synthetase inhibitor', 'indomethacin']",['menstrual blood loss'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin H2 Synthetase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0694689', 'cui_str': 'Menstrual blood (substance)'}]",9.0,0.368072,No significant placebo effect was observed.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yarkoni', 'Affiliation': ''}, {'ForeName': 'S O', 'Initials': 'SO', 'LastName': 'Anteby', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1207,31413010,"Combination of Metformin and Gefitinib as First-Line Therapy for Nondiabetic Advanced NSCLC Patients with EGFR Mutations: A Randomized, Double-Blind Phase II Trial.","PURPOSE


Preclinical and retrospective studies suggested a role for metformin in sensitizing patients who have diabetes with non-small cell lung cancer (NSCLC) to EGFR tyrosine kinase inhibitors (TKIs). We therefore examined its effects in combination with gefitinib in patients without diabetes harboring EGFR mutations (EGFRm).
PATIENTS AND METHODS


A total of 224 patients without diabetes with treatment-naïve stage IIIB-IV EGFRm NSCLC were randomly assigned in a 1:1 ratio to receive gefitinib plus either metformin or placebo. The primary endpoint was progression-free survival (PFS) rate at 1 year and secondary endpoints included overall survival (OS), PFS, objective response rate (ORR), and safety. Serum levels of IL6 were also examined in an exploratory analysis.
RESULTS


The median duration of follow-up was 19.15 months. The estimated 1-year PFS rates were 41.2% [95% confidence interval (CI), 30.0-52.2] with gefitinib plus metformin and 42.9% (95% CI, 32.6-52.7) with gefitinib plus placebo ( P  = 0.6268). Median PFS (10.3 months vs. 11.4 months) and median OS (22.0 months vs. 27.5 months) were numerically lower in the metformin group, while ORRs were similar between the two arms (66% vs. 66.7%). No significant treatment group differences were detected across all subgroups with respect to PFS, including those with elevated levels of IL6. Metformin combined with gefitinib resulted in a remarkably higher incidence of diarrhea compared with the control arm (78.38% vs. 43.24%).
CONCLUSIONS


Our study showed that addition of metformin resulted in nonsignificantly worse outcomes and increased toxicity and hence does not support its concurrent use with first-line EGFR-TKI therapy in patients without diabetes with EGFRm NSCLC.",2019,"Metformin combined with gefitinib resulted in a remarkably higher incidence of diarrhea compared to the control arm (78.38% vs 43.24%).
","['non-diabetic EGFRm NSCLC patients', 'sensitizing diabetic non-small cell lung cancer (NSCLC) patients to epidermal growth factor receptor(EGFR) tyrosine kinase inhibitors(TKIs', 'non-diabetic patients harboring EGFR mutations (EGFRm', '224 non-diabetic patients with treatment naïve stage IIIB-IV EGFRm NSCLC', 'non-diabetic advanced NSCLC patients with EGFR mutations']","['gefitinib', 'metformin and gefitinib', 'gefitinib plus placebo', 'Metformin', 'gefitinib plus metformin', 'metformin', 'gefitinib plus either metformin or placebo']","['median duration', 'elevated levels of interleukin-6', '1-year PFS rates', 'progression-free survival (PFS) rate', 'median OS', 'Median PFS', 'Serum levels of interleukin-6', 'overall survival (OS), PFS, objective response rate (ORR), and safety', 'diarrhea', 'toxicity']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",224.0,0.312064,"Metformin combined with gefitinib resulted in a remarkably higher incidence of diarrhea compared to the control arm (78.38% vs 43.24%).
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Yizhuo', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiao-Ju', 'Initials': 'XJ', 'LastName': 'Zhang', 'Affiliation': ""Department of Pulmonary Medicine, People's Hospital of Henan Province, Zhengzhou, China.""}, {'ForeName': 'Guoming', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Respiratory Medicine and Respiratory Intensive Care Unit, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, Southwest Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Cancer Institute, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': ""Department of Medical Oncology, People's Hospital of Shanxi Province, Xi'an, China.""}, {'ForeName': 'Biyong', 'Initials': 'B', 'LastName': 'Ren', 'Affiliation': 'Cancer Center, Chongqing Three Gorges Central Hospital, Chongqing, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Tian', 'Affiliation': 'Department of Respiratory Medicine, General Hospital of Chengdu Military Region of PLA, Chengdu, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Respiratory Medicine and Respiratory Intensive Care Unit, Xinqiao Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Hua-Liang', 'Initials': 'HL', 'LastName': 'Xiao', 'Affiliation': 'Department of Pathology, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, Fuling Center Hospital, Chongqing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Hengyi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Southwest Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Zhenzhou', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, Daping Hospital, Army Medical University, Chongqing, China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'The Medical Department, 3D Medicines Inc., Shanghai, P.R. China.'}, {'ForeName': 'Shangli', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'The Medical Department, 3D Medicines Inc., Shanghai, P.R. China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Respiratory Medicine, Daping Hospital, Army Medical University, Chongqing, China. heyong8998@126.com.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0437']
1208,32139505,Increased dystrophin production with golodirsen in patients with Duchenne muscular dystrophy.,"OBJECTIVE


To report safety, pharmacokinetics, exon 53 skipping, and dystrophin expression in golodirsen-treated patients with Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping.
METHODS


Part 1 was a randomized, double-blind, placebo-controlled, 12-week dose titration of once-weekly golodirsen; part 2 is an ongoing, open-label evaluation. Safety and pharmacokinetics were primary and secondary objectives of part 1. Primary biological outcome measures of part 2 were blinded exon skipping and dystrophin protein production on muscle biopsies (baseline, week 48) evaluated, respectively, using reverse transcription PCR and Western blot and immunohistochemistry.
RESULTS


Twelve patients were randomized to receive golodirsen (n = 8) or placebo (n = 4) in part 1. All from part 1 plus 13 additional patients received 30 mg/kg golodirsen in part 2. Safety findings were consistent with those previously observed in pediatric patients with DMD. Most of the study drug was excreted within 4 hours following administration. A significant increase in exon 53 skipping was associated with ∼16-fold increase over baseline in dystrophin protein expression at week 48, with a mean percent normal dystrophin protein standard of 1.019% (range, 0.09%-4.30%). Sarcolemmal localization of dystrophin was demonstrated by significantly increased dystrophin-positive fibers (week 48,  p  < 0.001) and a positive correlation (Spearman  r  = 0.663;  p  < 0.001) with dystrophin protein change from baseline, measured by Western blot and immunohistochemistry.
CONCLUSION


Golodirsen was well-tolerated; muscle biopsies from golodirsen-treated patients showed increased exon 53 skipping, dystrophin production, and correct dystrophin sarcolemmal localization.
CLINICALTRIALSGOV IDENTIFIER


NCT02310906.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that golodirsen is safe and Class IV evidence that it induces exon skipping and novel dystrophin as confirmed by 3 different assays.",2020,"A significant increase in exon 53 skipping was associated with ∼16-fold increase over baseline in dystrophin protein expression at week 48, with a mean percent normal dystrophin protein standard of 1.019% (range, 0.09%-4.30%).","['golodirsen-treated patients with Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping', 'patients with Duchenne muscular dystrophy', 'pediatric patients with DMD', 'Twelve patients']","['placebo', 'golodirsen']","['blinded exon skipping and dystrophin protein production on muscle biopsies (baseline, week 48) evaluated, respectively, using reverse transcription PCR and Western blot and immunohistochemistry', 'dystrophin production', 'dystrophin-positive fibers', 'dystrophin protein expression', 'Safety and pharmacokinetics', 'tolerated; muscle biopsies']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013264', 'cui_str': 'Cardiomyopathy, Dilated, X-Linked'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0079259', 'cui_str': 'Dystrophin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0033268'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0035380', 'cui_str': 'Reverse Transcription'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0949466', 'cui_str': 'Western Immunoblot'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",12.0,0.315679,"A significant increase in exon 53 skipping was associated with ∼16-fold increase over baseline in dystrophin protein expression at week 48, with a mean percent normal dystrophin protein standard of 1.019% (range, 0.09%-4.30%).","[{'ForeName': 'Diane E', 'Initials': 'DE', 'LastName': 'Frank', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Schnell', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Akana', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Saleh H', 'Initials': 'SH', 'LastName': 'El-Husayni', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Cody A', 'Initials': 'CA', 'LastName': 'Desjardins', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Morgan', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Charleston', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Sardone', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Domingos', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dickson', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Straub', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Guglieri', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Servais', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Muntoni', 'Affiliation': 'From Sarepta Therapeutics (D.E.F., F.J.S., C.A., S.H.E.-H., C.A.D., J.S.C.), Cambridge, MA; University College London (J.M., V.S., J.D., F.M.); Centre of Gene and Cell Therapy and Centre for Biomedical Sciences (G.D.), Royal Holloway, University of London, Egham, Surrey; Newcastle University John Walton Muscular Dystrophy Research Centre and the Newcastle Hospitals NHS Foundation Trust (V.S., M.G.), Newcastle upon Tyne, UK; Paediatric Neurology and Centro Clinico Nemo (E.M.), Catholic University and Policlinico Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCSS, Rome, Italy; Institute I-Motion (L.S.), Hôpital Armand-Trousseau, Paris, France; Neuromuscular Reference Center (L.S.), CHU Liège, Belgium; Great Ormond Street Hospital (F.M.); and NIHR Great Ormond Street Hospital Biomedical Research Centre (F.M.), London, UK. f.muntoni@ucl.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000009233']
1209,31955998,The Value of Intraoperative 3-Dimensional Fluoroscopy in the Treatment of Distal Radius Fractures: A Randomized Clinical Trial.,"PURPOSE


This study attempted to determine the clinical effectiveness of the intraoperative use of 3-dimensional fluoroscopy compared with conventional 2-dimensional fluoroscopy in patients with distal radius fractures.
METHODS


We performed a multicenter randomized clinical trial in which 206 patients were randomized between the use of 3-dimensional fluoroscopy or not during operative treatment of the distal radius fracture. The primary outcome was the quality of fracture reduction and fixation assessed on a postoperative computed tomography scan with a dichotomous outcome: indication for revision, yes or no.
RESULTS


There was no significant difference in whether the fracture required revision surgery: 31% (2-dimensional group) versus 24% (3-dimensional group). In 11% of distal radius fractures allocated to the 3-dimensional group, additional intraoperative corrections (screw replacements) were performed.
CONCLUSIONS


Compared with 2-dimensional fluoroscopy, the use of intraoperative 3-dimensional fluoroscopy does not appear to improve the quality of reduction and fixation in the management of patients with a distal radius fracture. However, the use of 3-dimensional fluoroscopy appears to have advantages such as more intraoperative revisions and less revision surgeries that this study could not clearly demonstrate.
TYPE OF STUDY/LEVEL OF EVIDENCE


Diagnostic II.",2020,"Compared with 2-dimensional fluoroscopy, the use of intraoperative 3-dimensional fluoroscopy does not appear to improve the quality of reduction and fixation in the management of patients with a distal radius fracture.","['Distal Radius Fractures', 'patients with a distal radius fracture', 'patients with distal radius fractures', '206 patients']","['3-dimensional fluoroscopy or not during operative treatment of the distal radius fracture', 'intraoperative 3-dimensional fluoroscopy', 'conventional 2-dimensional fluoroscopy', '2-dimensional fluoroscopy', '3-dimensional group, additional intraoperative corrections (screw replacements', 'Intraoperative 3-Dimensional Fluoroscopy', '3-dimensional fluoroscopy']","['quality of reduction and fixation', 'quality of fracture reduction and fixation assessed on a postoperative computed tomography scan with a dichotomous outcome: indication for revision, yes or no', 'fracture required revision surgery']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}]",206.0,0.139731,"Compared with 2-dimensional fluoroscopy, the use of intraoperative 3-dimensional fluoroscopy does not appear to improve the quality of reduction and fixation in the management of patients with a distal radius fracture.","[{'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Selles', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam UMC, University of Amsterdam, Nieuwegein, The Netherlands. Electronic address: c.a.selles@amc.nl.'}, {'ForeName': 'M S H', 'Initials': 'MSH', 'LastName': 'Beerekamp', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam UMC, University of Amsterdam, Nieuwegein, The Netherlands.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Leenhouts', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam UMC, University of Amsterdam, Nieuwegein, The Netherlands.'}, {'ForeName': 'M J M', 'Initials': 'MJM', 'LastName': 'Segers', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Trauma Unit, Department of Surgery, Amsterdam UMC, University of Amsterdam, Nieuwegein, The Netherlands.'}, {'ForeName': 'N W L', 'Initials': 'NWL', 'LastName': 'Schep', 'Affiliation': 'Department of Surgery, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of hand surgery,['10.1016/j.jhsa.2019.11.006']
1210,30765809,"Effects of prophylactic dexamethasone on postoperative nausea and vomiting in scoliosis correction surgery: a double-blind, randomized, placebo-controlled clinical trial.","Dexamethasone is widely used for postoperative nausea and vomiting (PONV) prophylaxis, but its effect on PONV prevention in paediatric patients is validated only in short minor surgical procedures. In this study, we aimed to determine whether a single dose of dexamethasone reduces PONV in highly invasive surgeries that require opioid-based postoperative analgesia. One hundred adolescents undergoing scoliosis correction surgery were randomized to receive intravenous dexamethasone 0.15 mg/kg (dexamethasone group) or saline (control group) at induction of anaesthesia. The primary outcome was the incidence of PONV in the 72 h postoperatively. Data for 98 patients were available for analysis. The 72-h incidence of PONV was significantly lower in the dexamethasone group than in the control group (62.5% vs 84.0%; RR 0.74, 95% CI 0.58-0.96, P = 0.02). During the first and second 24-h postoperative intervals, fewer patients in the dexamethasone group received rescue antiemetics. Visual analogue scale scores for nausea and pain were lower in the dexamethasone group than in the control group during the first 24 h postoperatively. Dexamethasone did not increase the number of adverse events. The results of this study showed that a single dose of dexamethasone was effective for reducing PONV after paediatric scoliosis correction surgery.",2019,Visual analogue scale scores for nausea and pain were lower in the dexamethasone group than in the control group during the first 24 h postoperatively.,"['highly invasive surgeries that require opioid-based postoperative analgesia', 'One hundred adolescents undergoing scoliosis correction surgery', 'scoliosis correction surgery', '98 patients were available for analysis', 'paediatric patients']","['placebo', 'Dexamethasone', 'intravenous dexamethasone 0.15\u2009mg/kg (dexamethasone group) or saline (control group) at induction of anaesthesia', 'prophylactic dexamethasone', 'dexamethasone']","['incidence of PONV', 'Visual analogue scale scores for nausea and pain', 'PONV', 'postoperative nausea and vomiting', '72-h incidence of PONV', 'number of adverse events', 'rescue antiemetics']","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}]",100.0,0.557605,Visual analogue scale scores for nausea and pain were lower in the dexamethasone group than in the control group during the first 24 h postoperatively.,"[{'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Wakamiya', 'Affiliation': 'Department of Anesthesiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Seki', 'Affiliation': 'Department of Anesthesiology, Keio University School of Medicine, Tokyo, Japan. hshiroyukiseki@gmail.com.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ideno', 'Affiliation': 'Department of Anesthesiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ihara', 'Affiliation': 'Department of Anesthesiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Minoshima', 'Affiliation': 'Department of Anesthesiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan. watakota@gmail.com.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Morisaki', 'Affiliation': 'Department of Anesthesiology, Keio University School of Medicine, Tokyo, Japan.'}]",Scientific reports,['10.1038/s41598-019-38764-8']
1211,32498098,Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial.,"BACKGROUND


The use of macroscopic on-site evaluation (MOSE) to estimate the adequacy of a specimen for histological diagnosis during endoscopic ultrasound (EUS)-guided fine-needle tissue acquisition (FNTA) has recently been advocated. This study aimed to evaluate the diagnostic yield of MOSE compared with conventional EUS-FNTA without rapid on-site evaluation (ROSE).
METHODS


This was an international, multicenter, prospective, randomized controlled study. After providing informed consent, consecutive adult patients referred for EUS-FNTA for solid lesions larger than 2 cm were randomized to a MOSE arm or to a conventional arm without ROSE. A designated cytopathologist from each center performed all cytopathological examinations for that center and was blinded to the randomization results. The primary outcome measure was the diagnostic yield, and the secondary outcomes included sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and the rate of procedure-related complications.
RESULTS


244 patients (122 conventional, 122 MOSE) were enrolled during the study period. No significant differences between the two arms were found in procedure time or rate of procedure-related adverse events. The diagnostic yield for the MOSE technique (92.6 %) was similar to that for the conventional technique (89.3 %;  P   = 0.37), with significantly fewer passes made (median: conventional 3, MOSE 2;  P   < 0.001).
CONCLUSIONS


EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes. This technique can be used when ROSE is not available.",2020,"CONCLUSIONS


EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes.","['244 patients (122 conventional, 122 MOSE) were enrolled during the study period', 'consecutive adult patients referred for EUS-FNTA for solid lesions larger than 2\u200acm']","['conventional EUS-FNTA', 'MOSE', 'Endoscopic ultrasound-guided tissue acquisition with or without macroscopic', 'conventional arm without ROSE', 'endoscopic ultrasound (EUS)-guided fine-needle tissue acquisition (FNTA']","['sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and the rate of procedure-related complications', 'procedure time or rate of procedure-related adverse events', 'diagnostic yield']","[{'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0441186', 'cui_str': 'Fine needle'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0441186', 'cui_str': 'Fine needle'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",244.0,0.133709,"CONCLUSIONS


EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes.","[{'ForeName': 'Charing C N', 'Initials': 'CCN', 'LastName': 'Chong', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Lakhtakia', 'Affiliation': 'Department of Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.'}, {'ForeName': 'Nam', 'Initials': 'N', 'LastName': 'Nguyen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Wah Kheong', 'Initials': 'WK', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya Medical Center, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Puri', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medanta, The Medicity, Gurgaon, India.'}, {'ForeName': 'Majid A', 'Initials': 'MA', 'LastName': 'Almadi', 'Affiliation': 'Division of Gastroenterology, King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Tiing Leong', 'Initials': 'TL', 'LastName': 'Ang', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kwek', 'Affiliation': 'Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Yasuda', 'Affiliation': 'Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Shinpei', 'Initials': 'S', 'LastName': 'Doi', 'Affiliation': 'Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Kida', 'Affiliation': 'Department of Gastroenterology, Kitasato University Hospital, Sagamihara, Japan.'}, {'ForeName': 'Hsiu-Po', 'Initials': 'HP', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Tsu-Yao', 'Initials': 'TY', 'LastName': 'Cheng', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.'}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Aiming', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Anthony W H', 'Initials': 'AWH', 'LastName': 'Chan', 'Affiliation': 'Department of Anatomical and Cellular Pathology, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Iwashita', 'Affiliation': 'First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.'}, {'ForeName': 'Anthony Y B', 'Initials': 'AYB', 'LastName': 'Teoh', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.'}]",Endoscopy,['10.1055/a-1172-6027']
1212,32500201,Efficacy of a novel urinary catheter for men with a local anesthetic injection port for catheter-related bladder discomfort: a randomized controlled study.,"PURPOSE


The NMOC-3WAY catheter ®  is a novel urinary catheter for men that can be used to inject a local anesthetic into the urethra. We sought to assess whether the injection of a local anesthetic into the urethra via the NMOC-3WAY catheter ®  would reduce catheter-related bladder discomfort (CRBD) after endovascular aneurysm repair (EVAR).
METHODS


Adult male patients who underwent elective EVAR for abdominal aortic aneurysms were randomly assigned to the 2% lidocaine group and the normal saline group (control group). CRBD was evaluated at 0, 1, 2, 4, and 6 h after surgery. The primary outcome was the incidence of CRBD at 0 h after surgery.
RESULTS


Data for 37 patients (19 in the lidocaine group and 18 in the control group) were analyzed. CRBD was observed at 0 h in six patients (31.6%; mild, n = 5; moderate, n = 1) in the lidocaine group and in five patients (27.8%; mild, n = 1; moderate, n = 3; severe, n = 1) in the control group. The control group showed a tendency to have severe CRBD at 0 h, although there was no significant difference in either the incidence (P = 0.80) or severity (P = 0.21) of CRBD between the two groups.
CONCLUSION


Our results suggest that the use of the NMOC-3WAY catheter ®  for the injection of 2% lidocaine into the urethra does not reduce the incidence of CRBD immediately after EVAR. However, it may reduce moderate or severe CRBD that may lead to postoperative distress and agitation.",2020,"The control group showed a tendency to have severe CRBD at 0 h, although there was no significant difference in either the incidence (P = 0.80) or severity (P = 0.21) of CRBD between the two groups.
","['37 patients (19 in the', 'men with a local anesthetic injection port for catheter-related bladder discomfort', 'Adult male patients who underwent elective EVAR for abdominal aortic aneurysms']","['novel urinary catheter', 'normal saline group (control group', 'lidocaine']","['CRBD', 'catheter-related bladder discomfort (CRBD', 'incidence of CRBD at 0\xa0h after surgery', 'severe CRBD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0549391', 'cui_str': 'Bladder discomfort'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",37.0,0.0766028,"The control group showed a tendency to have severe CRBD at 0 h, although there was no significant difference in either the incidence (P = 0.80) or severity (P = 0.21) of CRBD between the two groups.
","[{'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Imai', 'Affiliation': 'Department of Anesthesiology, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, 951-8510, Japan. hdkzimi@med.niigata-u.ac.jp.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Seino', 'Affiliation': 'Department of Anesthesiology, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, 951-8510, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Anesthesiology, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi-dori, Chuo-ku, Niigata, 951-8510, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02807-6']
1213,32496886,Influence of virtual keyboard design and usage posture on typing performance and muscle activity during tablet interaction.,"This study aimed to determine the effects of virtual keyboard designs and postures on task performance and muscle activity during tablet use. Eighteen healthy adults were randomly assigned to one of three postures (DESK, LAP, BED) to complete six sessions of 60-minute typing on a tablet with three virtual keyboards (STD, WIDE, SPLIT) twice in an experimental laboratory. Keystroke dynamics and muscle activity of the forearm and neck-shoulder regions were measured by electromyography. The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD,  p  = .015; SPLIT vs WIDE,  p  < .001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD,  p  = .021). Lap posture was associated with faster typing speed ( p  = .018) and higher forearm muscle activity ( p  < .05). Typing performance decreased ( p  < .001) with elevated neck extensor muscle activity ( p  = .042) when the task duration prolonged. The split virtual keyboard showed potential to improve tablet ergonomics under various postures.  Practitioner Summary:  Tablets have become widely used for a variety of tasks and have gradually expanded into the realm of mobile productivity and education. Adequate designs of virtual keyboards for tablets show the potential for increased task performance and decreased muscle activity pertinent to typing activity and posture constraints imposed by non-traditional work positions.  Abbreviations:  WPM: words per minute; IKI: inter-key press interval; EMG: electromyography; EDC: extensor digitorum communis; FDS: flexor digitorum superficialis; CES: cervical erector spinae; UT: upper trapezius; EA: electrical activity; MVC: maximum voluntary contraction; APDF: amplitude probability distribution function.",2020,"The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD, p = 0.015; SPLIT vs WIDE, p < 0.001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD, p = 0.021).",['Eighteen healthy adults'],"['virtual keyboard design and usage posture', 'virtual keyboard designs and postures']","['Typing performance', 'elevated neck extensor muscle activity', 'muscle activity of extensor digitorum communis', 'task performance and muscle activity', 'Keystroke dynamics and muscle activity of the forearm and neck-shoulder regions', 'forearm muscle activity']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224268', 'cui_str': 'Structure of extensor digitorum muscle of hand'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1760774', 'cui_str': 'Structure of muscle of forearm'}]",18.0,0.0249073,"The split virtual keyboard was found to be associated with faster typing speed (SPLIT vs STD, p = 0.015; SPLIT vs WIDE, p < 0.001) and decreased muscle activity of extensor digitorum communis (SPLIT vs STD, p = 0.021).","[{'ForeName': 'Ming-I Brandon', 'Initials': 'MB', 'LastName': 'Lin', 'Affiliation': 'Department of Industrial and Information Management, National Cheng-Kung University, Tainan, Taiwan.'}, {'ForeName': 'Ruei-Hong', 'Initials': 'RH', 'LastName': 'Hong', 'Affiliation': 'Institute of Information Management, National Cheng-Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Huang', 'Affiliation': 'Department of Industrial and Information Management, National Cheng-Kung University, Tainan, Taiwan.'}]",Ergonomics,['10.1080/00140139.2020.1778097']
1214,32501814,Ethanol-Based Disinfectants Containing Urea May Reduce Soap Sensitivity.,"BACKGROUND


The use of disinfectants is crucial to preventing the spread of nosocomial infections in health care workers. As many as 25 applications of hand disinfectants is a realistic default value during a working day. However, alcohol-based hand disinfectants may weaken skin barrier function and induce dryness and eczema, which decrease their acceptance.
OBJECTIVE


To evaluate the effect of ethanol-containing disinfectants with 5% urea on skin barrier function and on sensitivity to an irritant soap (sodium lauryl sulfate [SLS]).
METHODS


Twenty healthy volunteers treated one of their forearms twice daily for 17 days with an ethanol-containing gel with 5% urea. Two types of gels with urea were tested. Treatment was randomized to left or right forearm, and the contralateral forearm served as untreated control. Transepidermal water loss, skin capacitance (dryness), and sensitivity to SLS were evaluated.
RESULTS


Twice-daily application of the urea-containing ethanol gels lowered transepidermal water loss, prevented dryness, and reduced sensitivity to SLS compared with the untreated control skin.
CONCLUSIONS


Improved barrier function using this ethanol gel with urea may have relevance in daily disinfectant procedures.",2020,"RESULTS


Twice-daily application of the urea-containing ethanol gels lowered transepidermal water loss, prevented dryness, and reduced sensitivity to SLS compared with the untreated control skin.
","['Twenty healthy volunteers treated one of their forearms twice daily for 17 days with an', 'health care workers']","['Ethanol-Based Disinfectants Containing Urea', 'ethanol-containing disinfectants', 'contralateral forearm served as untreated control', 'irritant soap (sodium lauryl sulfate [SLS', 'ethanol-containing gel with 5% urea']","['skin barrier function and induce dryness and eczema', 'Transepidermal water loss, skin capacitance (dryness), and sensitivity to SLS', 'skin barrier function', 'Soap Sensitivity', 'transepidermal water loss, prevented dryness, and reduced sensitivity to SLS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022108', 'cui_str': 'Irritant'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0037231', 'cui_str': 'Sjögren-Larsson syndrome'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0242264', 'cui_str': 'Capacitance, Electrical'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037231', 'cui_str': 'Sjögren-Larsson syndrome'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",20.0,0.0301597,"RESULTS


Twice-daily application of the urea-containing ethanol gels lowered transepidermal water loss, prevented dryness, and reduced sensitivity to SLS compared with the untreated control skin.
","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lodén', 'Affiliation': 'From the Eviderm Institute AB, Solna, Sweden.'}]","Dermatitis : contact, atopic, occupational, drug",['10.1097/DER.0000000000000612']
1215,7008978,Therapeutic effects of topical benzydamine in gynecology.,"The study was performed on 124 patients divided into 4 groups on the basis of vaginal smears: 1) 60 patients with mild non-specific bacterial vaginitis; 2) 40 patients with moderate or severe non-specific bacterial vaginitis; 3) 10 patients with moderate or severe monilial vaginitis; 4) 14 patients with moderate or severe trichomonal vaginitis. Each group was subsequently divided at random into two subgroups, comprising the same number of patients, who were treated under double blind conditions with vaginal douches of 10/00 benzydamine of placebo (1 douching per day for 10 days). Specific standard therapy with antibiotics, antimycotic and antitrichomonal agents was used concomitantly in groups 2, 3 and 4 respectively. Vaginal smears, performed a few days after the end of the treatment period, and the improvement in symptoms and sings, demonstrated the curative action of benzydamine in mild non-specific vaginitis as well as its symptomatic effect and potentiation of specific therapy in moderate and severe bacterial, monilial and trichomonal vaginitis.",1980,"Vaginal smears, performed a few days after the end of the treatment period, and the improvement in symptoms and sings, demonstrated the curative action of benzydamine in mild non-specific vaginitis as well as its symptomatic effect and potentiation of specific therapy in moderate and severe bacterial, monilial and trichomonal vaginitis.","['124 patients divided into 4 groups on the basis of vaginal smears: 1) 60 patients with mild non-specific bacterial vaginitis; 2) 40 patients with moderate or severe non-specific bacterial vaginitis; 3) 10 patients with moderate or severe monilial vaginitis; 4) 14 patients with moderate or severe trichomonal vaginitis', 'gynecology']","['topical benzydamine', 'benzydamine', 'benzydamine of placebo', 'Specific standard therapy with antibiotics, antimycotic and antitrichomonal agents']",[],"[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0079104', 'cui_str': 'Cervical Smears'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0006852', 'cui_str': 'Vaginitis, Monilial'}, {'cui': 'C0040923', 'cui_str': 'Human Trichomoniases'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0005099', 'cui_str': 'Benzydamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0003447', 'cui_str': 'Antitrichomonals'}]",[],124.0,0.0295267,"Vaginal smears, performed a few days after the end of the treatment period, and the improvement in symptoms and sings, demonstrated the curative action of benzydamine in mild non-specific vaginitis as well as its symptomatic effect and potentiation of specific therapy in moderate and severe bacterial, monilial and trichomonal vaginitis.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mega', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Marcolin', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Maggino', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Gregorio', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
1216,31805396,Nocturnal bilevel positive airway pressure for the treatment of asthma.,"Nocturnal worsening of asthma may be due to reduced lung volumes and fewer sigh breaths, which have been shown to increase airway resistance and bronchoreactivity. We hypothesized that mimicking deep inspiration using nocturnal mechanical support would improve symptoms in patients with asthma. Subjects with asthma underwent usual care and bilevel positive airway pressure (PAP) therapy for 4 weeks, separated by 4 weeks, and methacholine challenge (PC 20 ) and subjective assessments. 13 patients with asthma alone and 8 with asthma + OSA completed the protocol. Change in bronchoreactivity (ratio of Post/Pre PC 20 ) was not significantly different during usual care and bilevel PAP [0.86 (IQR 0.19, 1.82) vs 0.94 (IQR 0.56, 2.5), p = 0.88], nor was the change in Asthma Control Test different: 0.1 ± 2.2 vs. -0.2 ± 2.9, p = 0.79, respectively. Bilevel PAP therapy for four weeks did not improve subjective or objective measures of asthma severity in patients with asthma or those with asthma and OSA, although there was heterogeneity in response.",2020,"Bilevel PAP therapy for four weeks did not improve subjective or objective measures of asthma severity in patients with asthma or those with asthma and OSA, although there was heterogeneity in response.","['patients with asthma', 'Subjects with asthma underwent', '13 patients with asthma alone and 8 with asthma\u202f+\u202fOSA completed the protocol', 'asthma']","['usual care and bilevel positive airway pressure (PAP) therapy', 'Bilevel PAP therapy']","['Change in bronchoreactivity', 'Nocturnal bilevel positive airway pressure', 'subjective or objective measures of asthma severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C1611149', 'cui_str': 'Bilevel positive airway pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity (regime/therapy)'}]",,0.0264125,"Bilevel PAP therapy for four weeks did not improve subjective or objective measures of asthma severity in patients with asthma or those with asthma and OSA, although there was heterogeneity in response.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, San Diego, CA, United States. Electronic address: rowens@ucsd.edu.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Campana', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Foster', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Schomer', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, San Diego, CA, United States.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2019.103355']
1217,31211691,Task-related fMRI BOLD response to hyperinsulinemia in healthy older adults.,"BACKGROUND


There is growing evidence to suggest that the brain is an important target for insulin action, and that states of insulin resistance may extend to the CNS with detrimental effects on cognitive functioning. Although the effect of systemic insulin resistance on peripheral organs is well-studied, the degree to which insulin impacts brain function in vivo remains unclear.
METHODS


This randomized, single-blinded, 2-way-crossover, sham-controlled, pilot study determined the effects of hyperinsulinemia on fMRI brain activation during a 2-back working memory task in 9 healthy older adults (aged 57-79 years). Each participant underwent two clamp procedures (an insulin infusion and a saline placebo infusion, with normoglycemia maintained during both conditions), to examine the effects of hyperinsulinemia on task performance and associated blood-oxygen-level dependent (BOLD) signal using fMRI.
RESULTS


Hyperinsulinemia (compared to saline control) was associated with an increase in both the spatial extent and relative strength of task-related BOLD signal during the 2-back task. Further, the degree of increased task-related activation in select brain regions correlated with greater systemic insulin sensitivity, as well as decreased reaction times and performance accuracy between experimental conditions.
CONCLUSION


Together, these findings provide evidence of insulin action in the CNS among older adults during periods of sustained cognitive demand, with the greatest effects noted for individuals with highest systemic insulin sensitivity.
FUNDING


This work was funded by the National Institutes of Health (5R21AG051958, 2016).",2019,"RESULTS


Hyperinsulinemia (compared to saline control) was associated with an increase in both the spatial extent and relative strength of task-related BOLD signal during the 2-back task.","['9 healthy older adults (aged 57-79 years', 'healthy older adults']","['clamp procedures (an insulin infusion and a saline placebo', 'hyperinsulinemia']","['Task-related fMRI BOLD response', 'spatial extent and relative strength of task-related BOLD signal', 'reaction times and performance accuracy', 'blood-oxygen-level dependent (BOLD) signal using fMRI']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinemia'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]",9.0,0.108205,"RESULTS


Hyperinsulinemia (compared to saline control) was associated with an increase in both the spatial extent and relative strength of task-related BOLD signal during the 2-back task.","[{'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Williams', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Bianca A', 'Initials': 'BA', 'LastName': 'Trombetta', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Rabab Z', 'Initials': 'RZ', 'LastName': 'Jafri', 'Affiliation': 'Diabetes Research Center and Pediatric Endocrine Unit and.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Koenig', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Chase D', 'Initials': 'CD', 'LastName': 'Wennick', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Becky C', 'Initials': 'BC', 'LastName': 'Carlyle', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'Diabetes Research Center and Pediatric Endocrine Unit and.'}, {'ForeName': 'Rexford S', 'Initials': 'RS', 'LastName': 'Ahima', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Russell', 'Affiliation': 'Diabetes Research Center and Pediatric Endocrine Unit and.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Salat', 'Affiliation': 'Brain Aging and Dementia Laboratory, Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Arnold', 'Affiliation': ""Department of Neurology, Alzheimer's Clinical and Translational Research Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.""}]",JCI insight,['10.1172/jci.insight.129700']
1218,31409183,Electroacupuncture Modulates Resting-State Functional Connectivity in the Default Mode Network for Healthy Older Adults.,"Aging involves cognitive decline and prominent alterations in brain activity. Electroacupuncture (EA), a traditional Chinese medicine approach, is demonstrated to be effective in improving cognitive function of older adults. However, the specific neural mechanism underlying this modulation effect remains unclear. In this study, we used functional magnetic resonance imaging (fMRI) to investigate whether EA could improve cognitive performance of community-dwelling older adults and whether these potential improvements are associated with the EA-induced brain functional connectivity alterations. Thirty healthy older adults were recruited and randomly assigned to the EA group and the control group. Behaviorally, we observed an EA-induced improvement in cognitive performance of older adults in the Montreal Cognitive Assessment. On a neural perspective, the EA intervention significantly increased the functional connectivity within the default mode network. Moreover, we found a positive association between the improvement in delayed memory performance and the alterations in the ventral medial prefrontal cortex-hippocampal formation connectivity in the EA group. This study extends previous findings by showing that healthy older adults exhibit neural plasticity manifested as increased functional connectivity after EA sessions, which could induce therapeutic effects in the treatment of neurodegenerative diseases.",2020,"Moreover, we found a positive association between the improvement in delayed memory performance and the alterations in the ventral medial prefrontal cortex-hippocampal formation connectivity in the EA group.","['community-dwelling older adults', 'Thirty healthy older adults', 'healthy older adults', 'Healthy Older Adults', 'older adults']","['Electroacupuncture', 'Electroacupuncture (EA', 'functional magnetic resonance imaging (fMRI', 'EA']","['delayed memory performance', 'functional connectivity', 'cognitive performance', 'ventral medial prefrontal cortex-hippocampal formation connectivity']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C3850122', 'cui_str': 'Ventral Medial Prefrontal Cortex'}, {'cui': 'C0175202', 'cui_str': 'Hippocampal Formation'}]",30.0,0.0270251,"Moreover, we found a positive association between the improvement in delayed memory performance and the alterations in the ventral medial prefrontal cortex-hippocampal formation connectivity in the EA group.","[{'ForeName': 'Dong-Qiong', 'Initials': 'DQ', 'LastName': 'Fan', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Hai-Chao', 'Initials': 'HC', 'LastName': 'Zhao', 'Affiliation': 'School of Biological Science and Medical Engineering, Beihang University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sheng', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Yun-Rui', 'Initials': 'YR', 'LastName': 'Liu', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988719868304']
1219,31642084,A randomized controlled trial to evaluate the efficacy of metacognitive training for people with schizophrenia applied by mental health nurses: Study protocol.,"AIM


To evaluate the efficacy of the Portuguese version of the metacognitive training (MCT) programme for schizophrenia and its effects on psychotic symptoms, insight into the disorder and functionality.
DESIGN


This is a randomized controlled trial that will be undertaken in six psychiatric institutions in Portugal.
METHODS


This study was approved in March 2019. The sample will consist of people with schizophrenia. The evaluation instruments will include sociodemographic and clinical questionnaires, the Psychotic Symptom Rating Scales, the Beck Cognitive Insight Scale, the World Health Disability Assessment Schedule, and the Personal and Social Performance Scale, applied to both groups at three different times. In the experimental group, the eight MCT modules will be applied over 4 weeks.
DISCUSSION


It is expected that at the end of the programme, the experimental group will have reduced severity of psychotic symptoms and improved insight into the disease and functionality.
IMPACT


Schizophrenia is a severe mental disorder that, in most cases, leads to the deterioration of cognitive and social functioning as a result of psychotic symptoms. Metacognitive training for schizophrenia has been used in several countries, but its efficacy remains unclear. It is a type of programme that consists of changing the cognitive infrastructure of delusions.",2020,"AIM


to evaluate the efficacy of the Portuguese version of the metacognitive training programme for schizophrenia and its effects on psychotic symptoms, insight into the disorder and functionality.
","['six psychiatric institutions in Portugal', 'people with schizophrenia applied by mental health nurses', 'people with schizophrenia']","['metacognitive training', 'Metacognitive training', 'metacognitive training programme']","['sociodemographic and clinical questionnaires, the Psychotic Symptom Rating Scales, the Beck Cognitive Insight Scale, the World Health Disability Assessment Schedule and the Personal and Social Performance Scale']","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0032729', 'cui_str': 'Portuguese Republic'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1964024', 'cui_str': 'Mental health nurse (occupation)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2959702', 'cui_str': 'Psychotic symptom rating scale (assessment scale)'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}, {'cui': 'C0222045'}, {'cui': 'C0043236', 'cui_str': 'Healths, International'}, {'cui': 'C0451124', 'cui_str': 'Disability assessment schedule (assessment scale)'}]",,0.0339876,"AIM


to evaluate the efficacy of the Portuguese version of the metacognitive training programme for schizophrenia and its effects on psychotic symptoms, insight into the disorder and functionality.
","[{'ForeName': 'Lara Manuela Guedes', 'Initials': 'LMG', 'LastName': 'de Pinho', 'Affiliation': 'Nursing School of São João de Deus, University of Évora, Évora, Portugal.'}, {'ForeName': 'Carlos Alberto da Cruz', 'Initials': 'CADC', 'LastName': 'Sequeira', 'Affiliation': 'NURSID group of Center for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}, {'ForeName': 'Francisco Miguel Correia', 'Initials': 'FMC', 'LastName': 'Sampaio', 'Affiliation': 'NURSID group of Center for Health Technology and Services Research (CINTESIS), Porto, Portugal.'}, {'ForeName': 'Nuno Barbosa', 'Initials': 'NB', 'LastName': 'Rocha', 'Affiliation': 'School of Health, Polytechnic of Porto, Porto, Portugal.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ferre-Grau', 'Affiliation': 'Universitat Rovira y Virgili, Tarragona, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14240']
1220,32507389,Pretreatment Reward Sensitivity and Frontostriatal Resting-State Functional Connectivity Are Associated With Response to Bupropion After Sertraline Nonresponse.,"BACKGROUND


Standard guidelines recommend selective serotonin reuptake inhibitors as first-line antidepressants for adults with major depressive disorder, but success is limited and patients who fail to benefit are often switched to non-selective serotonin reuptake inhibitor agents. This study investigated whether brain- and behavior-based markers of reward processing might be associated with response to bupropion after sertraline nonresponse.
METHODS


In a two-stage, double-blinded clinical trial, 296 participants were randomized to receive 8 weeks of sertraline or placebo in stage 1. Individuals who responded continued on another 8-week course of the same intervention in stage 2, while sertraline and placebo nonresponders crossed over to bupropion and sertraline, respectively. Data from 241 participants were analyzed. The stage 2 sample comprised 87 patients with major depressive disorder who switched medication and 38 healthy control subjects. A total of 116 participants with major depressive disorder treated with sertraline in stage 1 served as an independent replication sample. The probabilistic reward task and resting-state functional magnetic resonance imaging were administered at baseline.
RESULTS


Greater pretreatment reward sensitivity and higher resting-state functional connectivity between bilateral nucleus accumbens and rostral anterior cingulate cortex were associated with positive response to bupropion but not sertraline. Null findings for sertraline were replicated in the stage 1 sample.
CONCLUSIONS


Pretreatment reward sensitivity and frontostriatal connectivity may identify patients likely to benefit from bupropion following selective serotonin reuptake inhibitor failures. Results call for a prospective replication based on these biomarkers to advance clinical care.",2020,"RESULTS


Greater pretreatment reward sensitivity and higher resting-state functional connectivity between bilateral nucleus accumbens and rostral anterior cingulate cortex were associated with positive response to bupropion but not sertraline.","['adults with major depressive disorder', '241 participants were analyzed', '296 participants', '87 patients with major depressive disorder who switched medication and 38 healthy control subjects', '116 participants with major depressive disorder treated with sertraline in stage 1 served as an independent replication sample']","['sertraline', 'Bupropion', 'sertraline and placebo', 'sertraline or placebo', 'bupropion and sertraline']","['Pretreatment Reward Sensitivity and Frontostriatal Resting-State Functional Connectivity', 'reward sensitivity and higher resting-state functional connectivity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205250', 'cui_str': 'High'}]",296.0,0.273947,"RESULTS


Greater pretreatment reward sensitivity and higher resting-state functional connectivity between bilateral nucleus accumbens and rostral anterior cingulate cortex were associated with positive response to bupropion but not sertraline.","[{'ForeName': 'Yuen-Siang', 'Initials': 'YS', 'LastName': 'Ang', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Roselinde', 'Initials': 'R', 'LastName': 'Kaiser', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, Colorado.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Almeida', 'Affiliation': 'Department of Psychiatry, University of Texas at Austin, Dell Medical School, Austin, Texas.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Chase', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Webb', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Department of Psychiatry, Stony Brook University, Stony Brook, New York.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Deldin', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas, Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Bruder', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Crystal M', 'Initials': 'CM', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas, Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Cherise R', 'Initials': 'CR', 'LastName': 'Chin Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas, Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas, Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts; Center for Depression, Anxiety and Stress Research, McLean Hospital, Belmont, Massachusetts. Electronic address: dap@mclean.harvard.edu.'}]",Biological psychiatry,['10.1016/j.biopsych.2020.04.009']
1221,29975287,Apolipoprotein E4 genotype in combination with poor metabolic profile is associated with reduced cognitive performance in healthy postmenopausal women: implications for late onset Alzheimer's disease.,"OBJECTIVE


We hypothesized the association of metabolic profile on cognition in postmenopausal women will be greater among ApoE4 carriers compared with noncarriers.
METHODS


Metabolic biomarkers and measures of global cognition, executive functions, and verbal memory, collected among postmenopausal females, were used in this analysis. Clustering analyses of metabolic biomarkers revealed three phenotypes: healthy, predominantly hypertensive, and poor metabolic with (borderline normal laboratory values). General linear models tested whether an association of metabolic cluster with cognition differed by ApoE4 genotype.
RESULTS


In the total sample of 497 women, verbal memory was lower in the poor metabolic cluster (P = 0.04). Among ApoE4+ women, performance in all cognitive domains was lowest in the poor metabolic cluster. Differences in executive functions among metabolic clusters were detected only in ApoE4+ women (P value for interaction = 0.003).
CONCLUSIONS


In a general population of postmenopausal women, association between poor metabolic profile with reduction in cognitive performance is more apparent in women who carry an ApoE4 allele. These data indicate a window of opportunity for interventions to reverse the trajectory of the preclinical phase of Alzheimer's disease.",2019,"In the total sample of 497 women, verbal memory was lower in the poor metabolic cluster (P = 0.04).","['postmenopausal women', 'postmenopausal females', 'healthy postmenopausal women']",[],"['executive functions among metabolic clusters', 'cognitive performance', 'verbal memory', 'global cognition, executive functions, and verbal memory']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",497.0,0.0320796,"In the total sample of 497 women, verbal memory was lower in the poor metabolic cluster (P = 0.04).","[{'ForeName': 'Roksana', 'Initials': 'R', 'LastName': 'Karim', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Koc', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Jamaica R', 'Initials': 'JR', 'LastName': 'Rettberg', 'Affiliation': '23andMe, Mountain View, CA.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Henderson', 'Affiliation': 'Departments of Health Research and Policy (Epidemiology), and Neurology and Neurosciences, Stanford University, Stanford, CA.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'St John', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Allayee', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Roberta D', 'Initials': 'RD', 'LastName': 'Brinton', 'Affiliation': 'Department of Pharmacology and Pharmaceutical Science, School of Pharmacy, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001160']
1222,32497524,"Single-shot live-attenuated chikungunya vaccine in healthy adults: a phase 1, randomised controlled trial.","BACKGROUND


Chikungunya disease, which results in incapacitating arthralgia, has been reported worldwide. We developed a live-attenuated chikungunya virus (CHIKV) vaccine candidate designed for active immunisation of the general population living in endemic regions, as well as serving as a prophylactic measure for travellers to endemic areas.
METHODS


This single-blind, randomised, dose-escalation, phase 1 study investigated as primary outcome safety of a live-attenuated CHIKV vaccine candidate. At two professional clinical trial centres in Illinois and Alabama, USA, healthy volunteers aged 18-45 years were randomly assigned (1:1:2) to one of three escalating dose groups (low dose 3·2 × 10 3  per 0·1 mL; medium dose 3·2 × 10 4  per 1 mL; or high dose 3·2 × 10 5  50% tissue culture infection dose per 1 mL) and received a single-shot immunisation on day 0. Individuals in all groups were revaccinated with the highest dose on either month 6 or 12, and followed up for 28 days after revaccination. The safety analysis included all individuals who received the single vaccination; the immunogenicity analysis, which was a secondary outcome, included all individuals who completed the study without major protocol deviations (per-protocol population). The study is registered with ClinicalTrials.gov, NCT03382964, and is complete.
FINDINGS


The study was done between March 5, 2018, and Jul 23, 2019, with 120 adults recruited and enrolled between March 5 and June 21, 2018, and assigned to receive a low (n=31), medium (n=30), or high (n=59) dose of the vaccine. The vaccine was safe in the high-dose group and well tolerated in the low-dose and medium-dose groups. Four (7%) of 59 vaccinees in the high-dose group reported any local reaction, and 11 (36%), 12 (40%), and 40 (68%) volunteers in the low-dose, medium-dose, and high-dose groups, respectively, reported any solicited systemic reaction. No vaccine-related serious adverse events were reported. Data up to month 12 after a single immunisation of the 120 healthy volunteers showed a good immunogenicity profile with 100% seroconversion rates achieved at day 14 (103 [100%] of 103) and sustained for 1 year across all dose groups. Mean peak antibody titres at day 28 ranged from 592·6 to 686·9 geometric mean titres from the low-dose to high-dose groups, respectively. A single vaccination was sufficient to induce sustaining high-titre neutralising antibodies, as shown by the absence of an anamnestic response after any revaccination ranging from 94% to 100% of participants. Following revaccination, vaccinees were protected from vaccine-induced viraemia.
INTERPRETATION


A novel live-attenuated CHIKV vaccine was well tolerated and highly immunogenic in an adult population and could be an effective intervention for prophylaxis of chikungunya disease worldwide.
FUNDING


Valneva, Vienna, Austria; Coalition for Epidemic Preparedness Innovation and EU Horizon 2020.",2020,"Mean peak antibody titres at day 28 ranged from 592·6 to 686·9 geometric mean titres from the low-dose to high-dose groups, respectively.","['120 healthy volunteers', 'individuals who received the single vaccination; the immunogenicity analysis, which was a secondary outcome, included all individuals who completed the study without major protocol deviations (per-protocol population', 'At two professional clinical trial centres in Illinois and Alabama, USA, healthy volunteers aged 18-45 years', 'healthy adults', 'March 5, 2018, and Jul 23, 2019, with 120 adults recruited and enrolled between March 5 and June 21, 2018, and assigned to receive a low (n=31), medium (n=30), or high (n=59) dose of the', '3·2\u2008×', 'active immunisation of the general population living in endemic regions']","['Single-shot live-attenuated chikungunya vaccine', 'live-attenuated CHIKV vaccine candidate', 'vaccine', 'medium dose\u20083·2', 'live-attenuated chikungunya virus (CHIKV) vaccine']","['local reaction', 'solicited systemic reaction', 'tolerated', 'seroconversion rates', 'Mean peak antibody titres', 'good immunogenicity profile']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205991', 'cui_str': 'Active immunization'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008055', 'cui_str': 'Chikungunya fever'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0008056', 'cui_str': 'Chikungunya virus'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",120.0,0.316388,"Mean peak antibody titres at day 28 ranged from 592·6 to 686·9 geometric mean titres from the low-dose to high-dose groups, respectively.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wressnigg', 'Affiliation': 'Valneva, Vienna, Austria. Electronic address: nina.wressnigg@valneva.com.'}, {'ForeName': 'Romana', 'Initials': 'R', 'LastName': 'Hochreiter', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zoihsl', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fritzer', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bézay', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Klingler', 'Affiliation': 'Assign Data Management and Biostatistics, Innsbruck, Austria.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lingnau', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Lundberg', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Meinke', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Larcher-Senn', 'Affiliation': 'Assign Data Management and Biostatistics, Innsbruck, Austria.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Čorbic-Ramljak', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Eder-Lingelbach', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Dubischar', 'Affiliation': 'Valneva, Vienna, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bender', 'Affiliation': 'Valneva, Vienna, Austria.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30238-3']
1223,32493872,Effect of Music Therapy on the Chronic Pain and Midterm Quality of Life of Patients after Mechanical Valve Replacement.,"OBJECTIVE


To evaluate the effect of music therapy on the chronic pain and midterm quality of life of patients after mechanical valve replacement.
METHODS


Patients were divided into two groups according to whether or not they received music therapy. The patients in the music group received 30 minutes of music therapy every day for 6 months after the operation. The patients in the control group received standard treatment and had 30 minutes of quiet rest time every day in the same period. The short-form of McGill Pain Questionnaire (SF-MPQ) was used to evaluate the degree of postoperative chronic pain, and the SF-36 was used to evaluate the midterm quality of life of patients.
RESULTS


In terms of the degree of postoperative chronic pain, the score of the pain rating index (PRI) emotional item in the music group was significantly lower than that in the control group. In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
CONCLUSION


This study preliminarily showed that music therapy can effectively reduce chronic pain and improve midterm quality of life after surgery.",2020,"In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
","['Patients after Mechanical Valve Replacement', 'Patients', 'patients after mechanical valve replacement']","['music therapy', 'standard treatment and had 30 minutes of quiet rest time', 'Music Therapy']","['chronic pain', 'emotional function score', 'chronic pain and midterm quality of life', 'postoperative chronic pain, the score of the pain rating index (PRI) emotional item', 'midterm quality of life', 'Chronic Pain and Midterm Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0493251,"In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
","[{'ForeName': 'Ze-Wei', 'Initials': 'ZW', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Liang-Wan', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}]",Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia,['10.5761/atcs.oa.20-00022']
1224,32502072,Somatic Symptom Perception From a Predictive Processing Perspective: An Empirical Test Using the Thermal Grill Illusion.,"OBJECTIVE


In a predictive processing perspective, symptom perceptions result from an integration of preexisting information in memory with sensory input. Physical symptoms can therefore reflect the relative predominance of either sensory input or preexisting information. In this study, we used the thermal grill illusion (TGI), which applies interlaced warm and cool temperatures to the skin to create a paradoxical heat-pain experience. Assuming that the TGI compared with single-temperature stimulation relies more importantly on an active integration process of the brain to create this paradoxical sensation, we tested the hypothesis whether a manipulation of the expectations during TGI would have more impact than during single-temperature stimulation.
METHODS


Sixty-four participants received different temperature combinations (16/16°C, 40/40°C, 16/40°C) with neutral, positive (""placebo""), and negative (""nocebo"") instructions. Subjective stimulus intensity was rated, and neuroticism and absorption (openness to absorbing and self-altering experiences) served as potential moderating factors.
RESULTS


The TGI condition was rated highest. Overall, negative instructions increased (p < .001, d = 0.58), whereas positive instructions did not significantly change the TGI intensity perception (versus neutral; p = .144, d = 0.19). In the TGI condition, increased modulation of pain was observed with higher neuroticism (β = 0.33, p = .005) and absorption (β = 0.30, p = .010).
CONCLUSIONS


Whereas negative instructions induced a nocebo effect, no placebo effect emerged after positive instructions. The findings are in line with the predictive processing model of symptom perception for participants with higher levels of neuroticism and absorption.",2020,"Overall, negative instructions increased (p < .001, d = 0.58), whereas positive instructions did not significantly change the TGI intensity perception (vs. neutral; p = .144, d = 0.19).","['Sixty-four participants received different temperature combinations (16/16 °C, 40/40 °C, 16/40 °C) with']","['neutral, positive (""placebo""), and negative (""nocebo"") instructions', 'thermal grill illusion (TGI']","['modulation of pain', 'TGI intensity perception', 'Overall, negative instructions', 'Subjective stimulus intensity was rated and neuroticism and absorption (openness to absorbing and self-altering experiences']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0450328', 'cui_str': '16/16'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0020903', 'cui_str': 'Illusions'}]","[{'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1842981', 'cui_str': 'Neuroticism Traits'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0547049', 'cui_str': 'Openness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",64.0,0.102744,"Overall, negative instructions increased (p < .001, d = 0.58), whereas positive instructions did not significantly change the TGI intensity perception (vs. neutral; p = .144, d = 0.19).","[{'ForeName': 'Anne-Kathrin', 'Initials': 'AK', 'LastName': 'Bräscher', 'Affiliation': 'From the Department for Clinical Psychology, Psychotherapy, and Experimental Psychopathology (Bräscher, Witthöft), Johannes Gutenberg University Mainz, Mainz, Germany; Faculty for Health and Welfare Sciences (Sütterlin), Østfold University College, Halden; Division for Clinical Neuroscience (Sütterlin), Oslo University Hospital, Oslo, Norway; Psychologist Center (Scheuren), Luxembourg, Luxembourg; and Health Psychology, KU Leuven-University of Leuven (Van den Bergh), Leuven, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sütterlin', 'Affiliation': ''}, {'ForeName': 'Raymonde', 'Initials': 'R', 'LastName': 'Scheuren', 'Affiliation': ''}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Van den Bergh', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Witthöft', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000824']
1225,32508277,"A randomized controlled pilot study evaluating  Worry Less, Live More: The Mindful Way Through Anxiety Workbook .","Effective interventions for generalized anxiety exist, but barriers to treatment prevent their broad dissemination. Commercially available self-help materials may help bridge this gap, but few have been empirically evaluated. This study compared self-reported change in generalized anxiety symptomology and associated problems between community members with excessive worry who were randomly assigned to receive the  Worry Less, Live More: The Mindful Way through Anxiety Workbook  ( n  = 35) and those in a delayed condition ( n  = 29). Participants in the workbook condition reported significantly greater reductions between baseline and 11-week follow-up in self-reported worry ( η   2  =.15), general anxiety/tension ( η   2  =.13), and anxiety ( η   2  =.24) than those in the delayed condition, although no statistically significant differences across condition on changes in depression, functional impairment or acceptance were detected. This pilot study provides support for continued research examining the efficacy of acceptance-based behavioral therapy delivered in a self-help format.",2020,"Participants in the workbook condition reported significantly greater reductions between baseline and 11-week follow-up in self-reported worry ( η   2  =.15), general anxiety/tension ( η   2  =.13), and anxiety ( η   2  =.24) than those in the delayed condition, although no statistically significant differences across condition on changes in depression, functional impairment or acceptance were detected.","['community members with excessive worry', 'Worry Less, Live More']",['acceptance-based behavioral therapy'],"['depression, functional impairment or acceptance', 'generalized anxiety symptomology', 'general anxiety/tension', 'anxiety']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]",,0.0306532,"Participants in the workbook condition reported significantly greater reductions between baseline and 11-week follow-up in self-reported worry ( η   2  =.15), general anxiety/tension ( η   2  =.13), and anxiety ( η   2  =.24) than those in the delayed condition, although no statistically significant differences across condition on changes in depression, functional impairment or acceptance were detected.","[{'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Serowik', 'Affiliation': 'Psychology Service, VA Connecticut Healthcare System, Department of Psychiatry, Yale University School of Medicine , New Haven, CT, USA.'}, {'ForeName': 'Lizabeth', 'Initials': 'L', 'LastName': 'Roemer', 'Affiliation': 'Psychology Department, University of Massachusetts , Boston, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Suvak', 'Affiliation': 'Psychology Department, Suffolk University , Boston, MA, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Liverant', 'Affiliation': 'Psychology Department, Suffolk University , Boston, MA, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Orsillo', 'Affiliation': 'Psychology Department, Suffolk University , Boston, MA, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2020.1765858']
1226,32506135,Effects of Potassium or Sodium Supplementation on Mineral Homeostasis: A Controlled Dietary Intervention Study.,"CONTEXT


Although dietary potassium and sodium intake may influence calcium-phosphate metabolism and bone health, the effects on bone mineral parameters, including fibroblast growth factor 23 (FGF23), are unclear.
OBJECTIVE


Here, we investigated the effects of potassium or sodium supplementation on bone mineral parameters.
DESIGN, SETTING, PARTICIPANTS


We performed a post hoc analysis of a dietary controlled randomized, blinded, placebo-controlled crossover trial. Prehypertensive individuals not using antihypertensive medication (n = 36) received capsules containing potassium chloride (3 g/d), sodium chloride (3 g/d), or placebo. Linear mixed-effect models were used to estimate treatment effects.
RESULTS


Potassium supplementation increased plasma phosphate (from 1.10 ± 0.19 to 1.15 ± 0.19 mmol/L, P = 0.004), in line with an increase in tubular maximum of phosphate reabsorption (from 0.93 ± 0.21 to 1.01 ± 0.20 mmol/L, P < 0.001). FGF23 decreased (114.3 [96.8-135.0] to 108.5 [93.5-125.9] RU/mL, P = 0.01), without change in parathyroid hormone and 25-hydroxy vitamin D3. Fractional calcium excretion decreased (from 1.25 ± 0.50 to 1.11 ± 0.46 %, P = 0.03) without change in plasma calcium. Sodium supplementation decreased both plasma phosphate (from 1.10 ± 0.19 to 1.06 ± 0.21 mmol/L, P = 0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P = 0.02). Urinary and fractional calcium excretion increased (from 4.28 ± 1.91 to 5.45 ± 2.51 mmol/24 hours, P < 0.001, and from 1.25 ± 0.50 to 1.44 ± 0.54 %, P = 0.004, respectively).
CONCLUSIONS


Potassium supplementation led to a decrease in FGF23, which was accompanied by increase in plasma phosphate and decreased calcium excretion. Sodium supplementation reduced FGF23, but this was accompanied by decrease in phosphate and increase in fractional calcium excretion. Our results indicate distinct effects of potassium and sodium intake on bone mineral parameters, including FGF23.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01575041.",2020,"Sodium supplementation decreased both plasma phosphate (from 1.10±0.19 to 1.06±0.21 mmol/L, P=0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P=0.02).",['hypertensive individuals not using antihypertensive medication (n=36) received'],"['Potassium or Sodium Supplementation', 'sodium chloride', 'capsules containing potassium chloride', 'Potassium supplementation', 'dietary potassium and sodium intake', 'potassium and sodium intake', 'potassium or sodium supplementation', 'Sodium supplementation', 'placebo']","['parathyroid hormone and 25(OH)-vitamin D3', 'Fractional calcium excretion', 'bone mineral parameters, including FGF23', 'Mineral Homeostasis', 'Urinary and fractional calcium excretion', 'plasma calcium', 'bone mineral parameters', 'plasma phosphate', 'FGF23', 'plasma phosphate and decreased calcium excretion', 'tubular maximum of phosphate reabsorption', 'fractional calcium excretion']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0561938', 'cui_str': 'Potassium supplementation'}, {'cui': 'C0162800', 'cui_str': 'Dietary Potassium'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1272114', 'cui_str': 'Plasma calcium level'}, {'cui': 'C0858147', 'cui_str': 'Plasma phosphate'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}]",,0.11207,"Sodium supplementation decreased both plasma phosphate (from 1.10±0.19 to 1.06±0.21 mmol/L, P=0.03) and FGF23 (from 114.3 [96.8-135.0] to 108.7 [92.3-128.1] RU/mL, P=0.02).","[{'ForeName': 'Jelmer K', 'Initials': 'JK', 'LastName': 'Humalda', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Stanley M H', 'Initials': 'SMH', 'LastName': 'Yeung', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'Geleijnse', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, HB Wageningen, the Netherlands.'}, {'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Gijsbers', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, HB Wageningen, the Netherlands.'}, {'ForeName': 'Ineke J', 'Initials': 'IJ', 'LastName': 'Riphagen', 'Affiliation': 'Department of Laboratory Medicine, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology & Transplantation, Erasmus Medical Center, University Medical Center Rotterdam, CA Rotterdam, The Netherlands.'}, {'ForeName': 'Joris I', 'Initials': 'JI', 'LastName': 'Rotmans', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, RC Leiden, the Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam, DD Amsterdam Zuidoost, the Netherlands.'}, {'ForeName': 'Gerjan', 'Initials': 'G', 'LastName': 'Navis', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'de Borst', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, RB Groningen, the Netherlands.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa359']
1227,32498771,The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial.,"OBJECTIVE


To report the first randomized controlled trial to investigate if immersive virtual reality (VR) treatment can reduce patient perceptions of anxiety compared with a tablet-based control treatment in adults undergoing a first-time sternotomy.
METHODS


Twenty first-time sternotomy patients were prospectively randomized (blinded to investigator) to a control or VR intervention. The VR intervention was a game module ""Bear Blast"" (AppliedVR) displayed using a Samsung Gear Oculus VR headset. The control intervention was a tablet-based game with comparable audio, visual, and tactile components. The State-Trait Anxiety Inventory was administered before and after the assigned intervention. Self-reported anxiety measures between the control and VR groups were evaluated using an unpaired t test. Changes in self-reported anxiety measures pre- and post-intervention were evaluated with a paired t test for both the control and VR groups. The study took place from May 1, 2017, through January 1, 2019 (Institutional Review Board 16-009784).
RESULTS


Both control and VR groups were 90.0% male, with a mean ± SD age of 63.4 ± 9.11 and 69.5 ± 6.9 years, respectively. VR users experienced significant reductions in feeling tense and strained, and significant improvements in feeling calm when compared with tablet controls (P<0.05). They also experienced significant reductions in feeling strained, upset, and tense when compared with their own self-reported anxiety measure pre- and post-intervention (P<0.05). Critically, control patients had no change in these categories.
CONCLUSION


Immersive VR is an effective, nonpharmacologic approach to reducing preoperative anxiety in adults undergoing cardiac surgery and shows the validity and utility of this technology in adult patients.",2020,"VR users experienced significant reductions in feeling tense and strained, and significant improvements in feeling calm when compared with tablet controls (P<0.05).","['First-Time Sternotomy Patients', 'Twenty first-time sternotomy patients', 'adults undergoing a first-time sternotomy', 'adult patients', 'adults undergoing cardiac surgery']","['Immersive VR', 'Virtual Reality', 'control intervention was a tablet-based game with comparable audio, visual, and tactile components', 'immersive virtual reality (VR) treatment', 'control or VR intervention']","['feeling calm', 'Self-reported anxiety measures', 'patient perceptions of anxiety', 'Preoperative Anxiety', 'preoperative anxiety', 'State-Trait Anxiety Inventory']","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0522165', 'cui_str': 'Feeling calm'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",,0.0319872,"VR users experienced significant reductions in feeling tense and strained, and significant improvements in feeling calm when compared with tablet controls (P<0.05).","[{'ForeName': 'Tina M', 'Initials': 'TM', 'LastName': 'Hendricks', 'Affiliation': 'Mayo Clinic Alix School of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Claudia N', 'Initials': 'CN', 'LastName': 'Gutierrez', 'Affiliation': 'Mayo Clinic Alix School of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Stulak', 'Affiliation': 'Department of Cardiovascular Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Dearani', 'Affiliation': 'Department of Cardiovascular Surgery, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jordan D', 'Initials': 'JD', 'LastName': 'Miller', 'Affiliation': 'Department of Cardiovascular Surgery, Mayo Clinic, Rochester, MN; Departments of Surgery and Physiology & Biomedical Engineering, Mayo Clinic, Rochester, MN. Electronic address: Miller.jordan@mayo.edu.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2020.02.032']
1228,32498930,Metformin intervention against ovarian toxicity during chemotherapy for early breast cancer: Study protocol for a randomized double-blind placebo-controlled trial.,"BACKGROUND


With the significant improvement of the cure rate and survival rate of cancer patients, the survivors face quality-of-life problems, such as a significant decline in reproductive system development, ovarian reserves and function, and even fertility loss and early menopause. These problems are often highly associated with chemotherapy-induced ovarian damage in cancer treatment. However, there are no ideal treatment strategies at present. In our attempt to develop reagents and approaches for delaying ovarian aging and protecting chemotherapy-induced ovarian injury, we recently found that metformin may be the most promising drug to protect female malignant tumor patients from chemotherapy-induced ovarian injury. This trial aims to test whether administration of metformin during chemotherapy can protect the normal ovarian function of patients with early breast cancer.
METHODS


This study is prospective, randomized, double-blind and placebo-controlled. Female patients with early breast cancer (N = 314) will be randomly assigned to two groups (placebo, metformin 2000 mg). Metformin will be administered during and after chemotherapy for patients with stage I-IIIa breast cancer. The primary outcome will be the menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year. Patients will be followed up for 5 years to observe long-term ovarian function and prognosis, such as overall survival (OS), objective response rate (ORR), and disease-free survival (DFS). Quality of life and safety will also be assessed.
DISCUSSION


Our research will provide a new treatment strategy for fertility protection, and clinical treatment guidance for cancer patients.",2020,"The primary outcome will be the menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year.","['patients with stage I-IIIa breast cancer', 'cancer patients', 'Female patients with early breast cancer (N = 314', 'early breast cancer', 'female malignant tumor patients from chemotherapy-induced ovarian injury', 'patients with early breast cancer']","['placebo, metformin', 'Metformin', 'metformin', 'Metformin intervention', 'chemotherapy', 'placebo']","['ovarian toxicity', 'Quality of life and safety', 'cure rate and survival rate', 'menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year', 'overall survival (OS), objective response rate (ORR), and disease-free survival (DFS', 'normal ovarian function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C4324589', 'cui_str': 'Ovarian injury'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",314.0,0.583759,"The primary outcome will be the menstruation recovery rate 12 months after chemotherapy, defined as recovery of menstruation twice in a row within 1 year.","[{'ForeName': 'Jinjin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Panshi', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Breast Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Ren', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Cui', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Minli', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China.'}, {'ForeName': 'Xingrui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Breast Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China. Electronic address: lixingrui@tjh.tjmu.edu.cn.'}, {'ForeName': 'Shixuan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan, 430030, Hubei, China. Electronic address: sxwang@tjh.tjmu.edu.cn.'}]",Maturitas,['10.1016/j.maturitas.2020.04.010']
1229,32498932,Effects of a patient-centered program including the cumulative-complexity model in women with chronic pelvic pain: a randomized controlled trial.,"OBJECTIVES


To evaluate the effects of a patient-centered intervention including the cumulative-complexity model on quality of life related to health, coping behaviors, pain, self-perceived occupational performance and activity levels.
STUDY DESIGN


Randomized controlled trial. Forty-four women with a clinical diagnosis of chronic pelvic pain were randomized into two groups. Patients in the experimental group (n = 22) were included in a patient-centered intervention that involved relevant activities proposed by participants. Patients in the control group (n = 22) received a leaflet with information about chronic pelvic pain, physical activity, fear of movement, false beliefs, active lifestyle and behavioral advice.
MAIN OUTCOME MEASURES


The primary outcome measures were health-related quality of life assessed with the EuroQol-5D and coping behavior using the Coping Strategies Questionnaires. Secondary outcomes included severity of pain using a Visual Analogue Scale, self-perception of occupational performance using the Canadian Occupational Performance Measure and physical activity levels assessed by the International Physical Activity Questionnaire.
RESULTS


An analysis of variance with repeated measures showed, in the experimental group compared with the control group, significantly greater improvement from baseline to post-intervention in health-related quality of life (EuroQol-5D Visual Analog Scale values of 70.06 ± 16.44 vs. 57.38 ± 16.40, p = 0.026) and coping behavior (adaptive coping 113.00 ± 31.89 vs. 83.24 ± 16.69, p = 0.002). Pain, self-perception of performance and physical activity levels also significantly improved.
CONCLUSIONS


A patient-centered intervention considering the workload of patients and their capacity for performing health behaviors provides benefits regarding quality of life and coping behavior. Additionally, pain, self-perceived performance of relevant tasks and physical activity levels improved.",2020,"An analysis of variance with repeated measures showed, in the experimental group compared with the control group, significantly greater improvement from baseline to post-intervention in health-related quality of life (EuroQol-5D Visual Analog Scale values of 70.06 ± 16.44 vs. 57.38 ± 16.40, p = 0.026) and coping behavior (adaptive coping 113.00 ± 31.89 vs. 83.24 ± 16.69, p = 0.002).","['women with chronic pelvic pain', 'Forty-four women with a clinical diagnosis of chronic pelvic pain', 'Patients in the experimental group (n = 22']","['patient-centered program', 'patient-centered intervention', 'leaflet with information about chronic pelvic pain, physical activity, fear of movement, false beliefs, active lifestyle and behavioral advice']","['quality of life related to health, coping behaviors, pain, self-perceived occupational performance and activity levels', 'health-related quality of life (EuroQol-5D Visual Analog Scale values', 'coping behavior', 'Pain, self-perception of performance and physical activity levels', 'severity of pain using a Visual Analogue Scale, self-perception of occupational performance using the Canadian Occupational Performance Measure and physical activity levels assessed by the International Physical Activity Questionnaire', 'pain, self-perceived performance of relevant tasks and physical activity levels', 'health-related quality of life assessed with the EuroQol-5D and coping behavior using the Coping Strategies Questionnaires']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",44.0,0.117721,"An analysis of variance with repeated measures showed, in the experimental group compared with the control group, significantly greater improvement from baseline to post-intervention in health-related quality of life (EuroQol-5D Visual Analog Scale values of 70.06 ± 16.44 vs. 57.38 ± 16.40, p = 0.026) and coping behavior (adaptive coping 113.00 ± 31.89 vs. 83.24 ± 16.69, p = 0.002).","[{'ForeName': 'Mª José', 'Initials': 'MJ', 'LastName': 'Ariza-Mateos', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cabrera-Martos', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain. Electronic address: irenecm@ugr.es.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-López', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Rodríguez-Torres', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Torres-Sánchez', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Marie Carmen', 'Initials': 'MC', 'LastName': 'Valenza', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}]",Maturitas,['10.1016/j.maturitas.2020.04.005']
1230,32506738,Evaluation of the Effect of Maribavir on Cardiac Repolarization in Healthy Participants: Thorough QT/QTc Study.,"Maribavir is an orally bioavailable benzimidazole riboside in clinical development for treatment of cytomegalovirus infection in patients who undergo transplantation. Maribavir was evaluated in a thorough QT (TQT) study to determine any effects on cardiac repolarization. The effect of maribavir 100 and 1,200 mg oral doses on the baseline-adjusted and placebo-adjusted corrected QT (QTc) interval (delta delta QTc (ddQTc)) and other electrocardiogram (ECG) parameters was assessed in a randomized, phase I, placebo-controlled, four-period crossover study in healthy participants (men and women ages 18-50 years). Additionally, maribavir pharmacokinetics, safety, and tolerability were investigated. Moxifloxacin (400 mg) was used as a positive control to demonstrate the study's ability to detect QT prolongation. Digital 12-lead Holter ECG monitoring was performed over 22 hours following study drug administration. Individual, Fridericia's, and Bazett's QTc intervals were calculated. Of 52 randomized participants (29 ± 8.1 years old; 31 men (60%)), 50 (96%) completed the study. For both 100-mg and 1200-mg doses of maribavir, analysis of ddQTc demonstrated that the upper bound of the two-sided 90% confidence interval was below the 10-ms threshold at all time points. The concentration-effect analysis demonstrated no relationship between ddQTc and plasma concentrations of maribavir (and its metabolite). There were no clinically meaningful changes in heart rate and systolic blood pressure. The most common adverse event was dysgeusia; no serious adverse events were reported. This TQT study demonstrated that maribavir did not have impact on cardiac repolarization.",2020,There were no clinically meaningful changes in heart rate and systolic blood pressure.,"['Of 52 randomized participants (29 ± 8.1 years old; 31 [60%] males), 50 (96%) completed the study', 'Healthy Participants', 'healthy participants (males and females ages 18-50', 'transplant patients']","['baseline- and placebo-adjusted QTc interval (delta delta QTc [ddQTc]) and other electrocardiogram (ECG', 'Moxifloxacin', 'Maribavir', 'bioavailable benzimidazole riboside', 'placebo']","['Cardiac Repolarization', 'heart rate and systolic blood pressure', 'ddQTc and plasma concentrations of maribavir (and its metabolite', 'maribavir pharmacokinetics, safety, and tolerability', 'cardiac repolarization', ""Individual (QTcIb), Fridericia's (QTcF), and Bazett's (QTcB) QTc intervals""]","[{'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0005050', 'cui_str': 'Benzimidazoles'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",52.0,0.108432,There were no clinically meaningful changes in heart rate and systolic blood pressure.,"[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Ilic', 'Affiliation': 'Shire, a Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Ivy', 'Initials': 'I', 'LastName': 'Song', 'Affiliation': 'Shire, a Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Shire, a Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Shire, a Takeda Company, Lexington, Massachusetts, USA.'}]",Clinical and translational science,['10.1111/cts.12814']
1231,32512690,Attentiveness and Fidgeting While Using a Stand-Biased Desk in Elementary School Children.,"Standing desks are a viable option to decrease sedentary time in the classroom. However, it is important that standing desks are not detrimental to classroom behavior or learning. The purpose of this study was to evaluate the impact of stand-biased desks on fidgeting and attentiveness. Ninety-seven students in grades 3, 4, and 6 (ages 8-12 years) volunteered to participate in this study. The intervention employed a within-classroom crossover design, with teacher-determined allocation for seating within each classroom and included the replacement of one-half of the traditional sitting desks with stand-biased desks. Direct observation of student's attentive and fidgeting behaviors occurred at three assessment periods, at baseline when all students were in a sitting desk condition and at the end of each nine-week intervention. Stand-biased desks did not influence fidgeting behavior, but did have an impact on attentive behavior. Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention. While fidgeting and non-attentive episodes ( p  = 0.034) were significantly related, the type of desk did not significantly moderate this relationship ( p  = 0.810). Standing desks can be incorporated into the classroom without negatively influencing classroom behavior.",2020,Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention.,"['Elementary School Children', 'Ninety-seven students in grades 3, 4, and 6 (ages 8-12 years) volunteered to participate in this study']",['teacher-determined allocation for seating within each classroom and included the replacement of one-half of the traditional sitting desks with stand-biased desks'],"['Attentiveness and Fidgeting', 'sedentary time']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]","[{'cui': 'C0233413', 'cui_str': 'Attentiveness'}, {'cui': 'C0424235', 'cui_str': 'Fidgeting'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",97.0,0.0251875,Students that were less attentive at baseline had a 40-80% increase incidence rate in non-attentive behavior while in the traditional desk as compared to the stand-biased desk after the intervention.,"[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Swartz', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Tokarek', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Strath', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Krista M', 'Initials': 'KM', 'LastName': 'Lisdahl', 'Affiliation': 'Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}, {'ForeName': 'Chi C', 'Initials': 'CC', 'LastName': 'Cho', 'Affiliation': 'Center for Aging and Translational Research, University of Wisconsin-Milwaukee, Milwaukee, WI 53201, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17113976']
1232,32517806,Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial.,"BACKGROUND


Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback.
METHODS


Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness.
DISCUSSION


We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03504124. Registered on 20 April 2018.",2020,The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months.,"['hypertension control in Guatemala', '18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total']","['multicomponent program', 'protocol-based hypertension\xa0treatment using a\xa0standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback']","['systolic and diastolic blood pressure', 'proportion of patients with controlled hypertension', 'implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",44.0,0.0630916,The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months.,"[{'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Paniagua-Avila', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Meredith P', 'Initials': 'MP', 'LastName': 'Fort', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala.'}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Department of Family Medicine, and Adult and Child Center for Health Outcomes Research and Delivery Science, University of Colorado, Aurora, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Gulayin', 'Affiliation': 'Department of Research in Chronic Diseases, Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Hernández-Galdamez', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala.'}, {'ForeName': 'Kristyne', 'Initials': 'K', 'LastName': 'Mansilla', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Palacios', 'Affiliation': 'Programa Nacional de Enfermedades Crónicas, Ministerio de Salud y Asistencia Social (MSPAS), Guatemala City, Guatemala.'}, {'ForeName': 'Ana Lucia', 'Initials': 'AL', 'LastName': 'Peralta', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Roche', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Rubinstein', 'Affiliation': 'Programa Nacional de Enfermedades Crónicas, Ministerio de Salud y Asistencia Social (MSPAS), Guatemala City, Guatemala.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine and Tulane University Translational Science Institute, New Orleans, LA, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramirez-Zea', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama - INCAP, Calzada Roosevelt 6-25 zona 11, INCAP III, Guatemala City, Guatemala. mramirez@incap.int.'}, {'ForeName': 'Vilma', 'Initials': 'V', 'LastName': 'Irazola', 'Affiliation': 'Tulane University School of Public Health and Tropical Medicine and Tulane University Translational Science Institute, New Orleans, LA, USA.'}]",Trials,['10.1186/s13063-020-04345-8']
1233,32500957,No evidence of a legacy effect on survival following randomization to extended hours dialysis in the ACTIVE Dialysis trial.,"AIM


Extended hours haemodialysis is associated with superior survival to standard hours. However, residual confounding limits the interpretation of this observation. We aimed to determine the effect of a period of extended hours dialysis on long-term survival among participants in the ACTIVE Dialysis trial.
METHODS


Two-hundred maintenance haemodialysis recipients were randomized to extended hours dialysis (median 24 h/wk) or standard hours dialysis (median 12 h/wk) for 12 months. Further pre-specified observational follow up occurred at 24, 36 and 60 months. Vital status and modality of renal replacement therapy were ascertained.
RESULTS


Over the 5 years, 38 participants died, 30 received a renal transplant, and 6 were lost to follow up. Total weekly dialysis hours did not differ between standard and extended groups during the follow-up period (14.1 hours [95%CI 13.4-14.8] vs 14.8 hours [95%CI 14.1-15.6]; P = .16). There was no difference in all-cause mortality (hazard ratio for extended hours 0.91 [95%CI 0.48-1.72]; P = .77). Similar results were obtained after censoring participants at transplantation, and after adjusting for potential confounding variables. Subgroup analysis did not reveal differences in treatment effect by region, dialysis setting or vintage (P-interaction .51, .54, .12, respectively).
CONCLUSION


Twelve months of extended hours dialysis did not improve long-term survival nor affect dialysis hours after the intervention period. An urgent need remains to further define the optimal dialysis intensity across the broad range of dialysis recipients.",2020,There was no difference in all-cause mortality (hazard ratio for extended hours 0.91,"['38 participants died, 30 received a renal transplant, and 6 were lost to follow up', 'participants in the ACTIVE Dialysis trial', 'Two-hundred maintenance hemodialysis recipients']",[],"['cause mortality', 'Total weekly dialysis hours', 'long-term survival', 'survival']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",200.0,0.23794,There was no difference in all-cause mortality (hazard ratio for extended hours 0.91,"[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Smyth', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health and University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Gray', 'Affiliation': 'Renal Department, Sunshine Coast University Hospital, Birtinya, Queensland, Australia.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': 'Renal Services, North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Hong', 'Affiliation': ""Renal Department, Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rogers', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health and University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, University of Electronic Science and Technology of China Medical School, Chengdu, China.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, North Territory, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gallagher', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health and University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health and University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Jardine', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health and University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nephrology (Carlton, Vic.)",['10.1111/nep.13737']
1234,32504178,"Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique: comparable stability, function and return-to-sport level but less donor site morbidity in athletes after 10 years.","INTRODUCTION


The use of quadriceps tendon-patellar bone (QTB) autograft for anterior cruciate ligament (ACL) reconstruction is gaining momentum. Yet, long-term results that compare this procedure with established methods are lacking. The aim of this study was to report and compare long-term results of ACL reconstruction using QTB autografts versus bone-patellar tendon-bone (BPTB) autografts, both anchored using a hardware-free press-fit fixation technique.
MATERIALS AND METHODS


60 athletes (Tegner score ≥6) with primary ACL rupture were prospectively randomized into two groups. 56 patients were evaluated after a mean duration of 12.2 ± 1.9 months (range 10-14) and 43 patients after 10.3 ± 0.2 years (range 10-11).
RESULTS


On final follow-up, 90% of patients scored very good and good results in the functional Lysholm score (mean 99 ± 7.1, range 74-100 points). Normal or almost normal IKDC score was reported by 84% of the patients (mean 97 ± 9.5, range 60-100 points). The activity level decreased in the Tegner score from median of 7 before injury to 6 after 10 years. The KT-1000 arthrometer showed a difference in the anterior translation of less than 3 mm (mean 1.0 ± 1.2, range - 1 to 5 mm) in 91% of the patients. Significant degeneration was radiologically detected in one patient per group. No tunnel widening was seen in any patient. Up to 97% of all patients were satisfied with the operative procedure. No significant differences were found in the mentioned parameters between the two groups and also in comparison with the 1-year results. The only significant difference was in the donor site morbidity. Significantly more patients in the BPTB group had complaints during kneeling both at 1 (p < 0.001) and 10 years (p = 0.019). Squatting was also subjectively more problematic in the BPTB group than in the QTB group both after 1 (p = 0.003) and 10 years (p = 0.046).
CONCLUSIONS


This study shows equally good functional, clinical and radiological long-term results for both hardware-free methods of ACL reconstruction. These results clinically confirm the safety of press-fit anchoring after 10 years. The failure rate in this study was very low, with only one re-rupture in 10 years. The increased donor site morbidity when using the BPTB autograft compared to the QTB autograft supports already reported data. It was also seen in this study for the implant-free press-fit techniques.
STUDY DESIGN


Prospective and randomized, level of evidence 2.",2020,No significant differences were found in the mentioned parameters between the two groups and also in comparison with the 1-year results.,"['56 patients were evaluated after a mean duration of 12.2\u2009±\u20091.9\xa0months (range 10-14) and 43 patients after 10.3\u2009±\u20090.2\xa0years (range 10-11', 'athletes after 10\xa0years', '60 athletes (Tegner score ≥6) with primary ACL rupture']","['ACL reconstruction using QTB autografts versus bone-patellar tendon-bone (BPTB) autografts', 'quadriceps tendon-patellar bone (QTB) autograft for anterior cruciate ligament (ACL) reconstruction', 'QTB', 'Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique']","['Significant degeneration', 'activity level', 'tunnel widening', 'failure rate', 'functional Lysholm score', 'donor site morbidity', 'anterior translation', 'stability, function and return-to-sport level', 'Normal or almost normal IKDC score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0224941', 'cui_str': 'Structure of quadriceps tendon'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0441550', 'cui_str': 'Press-fit component fixation'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",56.0,0.0289652,No significant differences were found in the mentioned parameters between the two groups and also in comparison with the 1-year results.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Barié', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Clinic for Orthopedics and Trauma Surgery, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany. abarie@web.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Sprinckstub', 'Affiliation': 'Center for Surgery B. Nimis and Dr. T. Sprinckstub, Zur Helde 4, 69168, Wiesloch, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Center for Orthopedics of the Knee, Hopfenstraße 4, 69469, Weinheim, Germany.'}, {'ForeName': 'Ayham', 'Initials': 'A', 'LastName': 'Jaber', 'Affiliation': 'Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Clinic for Orthopedics and Trauma Surgery, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03508-1']
1235,32514638,Invited Discussion on: Effect of Photobiomodulation on Ecchymosis After Rhinoplasty-A Randomized Single-Blind Controlled Trial.,,2020,,[],['Photobiomodulation'],['Ecchymosis'],[],[],"[{'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",,0.0949956,,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Hafezi', 'Affiliation': 'Iran University of Medical Sciences, St. Fatima Hospital and Burn Research Center, Suite 12, Number 33, Asef St., Zaferanieh, Tehran, 1988893337, Iran. fhafezi32@gmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01795-y']
1236,32515099,Alcohol use and injury risk in Thailand: A case-crossover emergency department study.,"INTRODUCTION AND AIMS


While injuries and alcohol contribute to a large proportion of the disease burden in Thailand, no well-designed underlying study has yet been published. This study aims to evaluate the relationship between acute alcohol consumption and injury risk in Thailand.
DESIGN AND METHODS


Using the case-crossover design, this study examined 520 injured patients aged 18 years and older from two emergency departments in Meuang District, Chiang-Mai Province, Thailand, from June to August of 2016. The case period was defined as 6 h prior to injury, the two control periods as the same 6-h period at 1 day and 7 days prior to injury. Alcohol exposure and the amount consumed were measured for these periods.
RESULTS


Twenty percent of injured patients consumed alcohol within the 6 h prior to injury, averaging 6.9 drinks during that time. The odds of injury for those individuals consuming alcoholic beverages was 5.0 (95% confidence interval 3.0, 8.2) times greater compared to non-exposure individuals; every additional drink consumed increased the odds of injury by 1.3 (95% confidence interval 1.2, 1.4). Alcohol use significantly increased the odds of sustaining an unintentional injury, intentional injury inflicted by someone else or experiencing a road traffic injury (among drivers). The dose-response analysis indicated alcohol use significantly increased the risks of unintentional injury and road traffic injuries (among drivers).
DISCUSSION AND CONCLUSIONS


Exposure to alcohol increased the odds of injury in a dose-dependent fashion; hence, comprehensive, cost-effective strategies should be implemented in Thailand to reduce alcohol exposure, binge drinking and drunk driving.",2020,"The dose-response analysis indicated alcohol use significantly increased the risks of unintentional injury and road traffic injuries (among drivers).
","['520 injured patients aged 18\u2009years and older from two emergency departments in Meuang District, Chiang-Mai Province, Thailand, from June to August of 2016', 'Thailand']",[],"['risks of unintentional injury and road traffic injuries', 'odds of sustaining an unintentional injury, intentional injury inflicted by someone else or experiencing a road traffic injury']","[{'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151736', 'cui_str': 'Accidental injury'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0151737', 'cui_str': 'Intentional injury'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",520.0,0.0189327,"The dose-response analysis indicated alcohol use significantly increased the risks of unintentional injury and road traffic injuries (among drivers).
","[{'ForeName': 'Bundit', 'Initials': 'B', 'LastName': 'Sornpaisarn', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'Sarnti', 'Initials': 'S', 'LastName': 'Sornpaisarn', 'Affiliation': 'Faculty of Health Science, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Shield', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}]",Drug and alcohol review,['10.1111/dar.13094']
1237,32517382,Post-Exercise Recovery of Ultra-Short-Term Heart Rate Variability after Yo-Yo Intermittent Recovery Test and Repeated Sprint Ability Test.,"This study aimed to examine the agreement and acceptance of ultra-short-term heart rate (HR) variability (HRV UST ) measures during post-exercise recovery in college football players. Twenty-five male college football players (age: 19.80 ± 1.08 years) from the first division of national university championship voluntarily participated in the study. The participants completed both a repeated sprint ability test (RSA) and a Yo-Yo intermittent recovery test level 1 (YYIR1) in a randomized order and separated by 7 days. Electrocardiographic signals (ECG) were recorded in a supine position 10 min before and 30 min after the exercise protocols. The HR and HRV data were analyzed in the time segments of baseline 5~10 min (Baseline), post-exercise 0~5 min (Post 1), post-exercise 5~10 min (Post 2), and post-exercise 25~30 min (Post 3). The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST  and 5-min criterion (HRV criterion ) of each time segment. The correlation of time-domain HRV variables to 5-min natural logarithm of low frequency power (LnLF) and high frequency power (LnHF), and LF:HF ratio were calculated. The results showed that the HRV UST  of LnSDNN, LnRMSSD, and LnSDNN:LnRMSSD ratio showed trivial to small effect sizes (ES) (-0.00~0.49), very large and nearly perfect interclass correlation coefficients (ICC) (0.74~0.95), and relatively small values of bias (RSA: 0.01~-0.12; YYIR1: -0.01~-0.16) to the HRV criterion  in both exercise protocols. In addition, the HRV UST  of LnLF, LnHF, and LnLF:LnHF showed trivial to small ES (-0.04~-0.54), small to large ICC (-0.02~0.68), and relatively small values of bias (RSA: -0.02~0.65; YYIR1: 0.03~-0.23) to the HRV criterion  in both exercise protocols. Lastly, the 1-min LnSDNN:LnRMSSD ratio was significantly correlated to the 5-min LnLF:LnHF ratio with moderate~high level ( r  = 0.43~0.72;  p  < 0.05) during 30-min post-exercise recovery. The post-exercise 1-min HRV assessment in LnSDNN, LnRMSSD, and LnSDNN:LnRMSSD ratio was acceptable and accurate in the RSA and YYIR1 tests, compared to the 5-min time segment of measurement. The moderate to high correlation coefficient of the HRV UST  LnSDNN:LnRMSSD ratio to the HRV criterion  LnLF:LnHF ratio indicated the capacity to facilitate the post-exercise shortening duration of HRV measurement after maximal anaerobic or aerobic shuttle running. Using ultra-short-term record of LnSDNN:LnRMSSD ratio as a surrogate for standard measure of LnLF:LnHF ratio after short-term bouts of maximal intensity field-based shuttle running is warranted.",2020,"The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST  and 5-min criterion (HRV criterion ) of each time segment.","['college football players', 'Twenty-five male college football players (age: 19.80 ± 1.08 years) from the first division of national university championship voluntarily participated in the study']",['repeated sprint ability test (RSA) and a Yo-Yo intermittent recovery test level 1 (YYIR1'],"['natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio', 'Electrocardiographic signals (ECG', 'agreement and acceptance of ultra-short-term heart rate (HR) variability', 'HRV UST ) measures', 'HR and HRV data', 'time-domain HRV variables to 5-min natural logarithm of low frequency power (LnLF) and high frequency power (LnHF), and LF:HF ratio']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517489', 'cui_str': '1.08'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]",25.0,0.0701879,"The natural logarithm of the standard deviation of normal-to-normal intervals (LnSDNN), root mean square of successive normal-to-normal interval differences (LnRMSSD), and LnSDNN:LnRMSSD ratio was compared in the 1st min HRV UST  and 5-min criterion (HRV criterion ) of each time segment.","[{'ForeName': 'Chin-Hwai', 'Initials': 'CH', 'LastName': 'Hung', 'Affiliation': 'Physical Education Office, Fu Jen Catholic University, New Taipei City 24205, Taiwan.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Bezerra', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chiu', 'Affiliation': 'Physical Education Office, Fu Jen Catholic University, New Taipei City 24205, Taiwan.'}, {'ForeName': 'Chia-Hua', 'Initials': 'CH', 'LastName': 'Chien', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Crowley-McHattan', 'Affiliation': 'School of Health and Human Sciences, Southern Cross University, Lismore 2480, Australia.'}, {'ForeName': 'Yung-Sheng', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': 'Department of Exercise and Health Sciences, University of Taipei, Taipei 11153, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17114070']
1238,32525036,"One layer or two: Does it matter when performing a handsewn bowel anastomosis? Invited Commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastamosis-an open labeled, randomized controlled trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.075286,,"[{'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Wakam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI, USA. Electronic address: gwakam@med.umich.edu.'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI, USA.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.088']
1239,31854221,Sparing the pronator quadratus for volar plating of distal radius fractures: a comparative study of two methods.,"OBJECTIVES


The objective of this study was to compare the results of two methods for sparing the pronator quadratus in volar plating of distal radius fractures.
METHODS


A total of 110 patients were randomized to volar plating with sparing of the pronator quadratus either by a transverse incision along the distal border of the pronator quadratus (Group A, 55 people) or by the brachioradialis splitting method (Group B, 55 people). The operative and radiation time, range of motion, grip strength, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, Visual Analog Scale (VAS) scores, and complications were recorded.
RESULTS


There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups. We found no significant differences in range of motion, grip strength, VAS scores, and DASH scores at any of the study intervals between the groups. Although neurapraxia of the superficial branch of the radial nerve was more common in Group B than in Group A (6.7% vs. 0%), the difference was not significant.
CONCLUSIONS


Both methods were efficient approaches for sparing the pronator quadratus and had similar clinical outcomes, but they had different indications.",2020,"There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups.","['110 patients', 'distal radius fractures']","['volar plating with sparing of the pronator quadratus either by a transverse incision along the distal border of the pronator quadratus (Group A, 55 people) or by the brachioradialis splitting method']","['range of motion, grip strength, VAS scores, and DASH scores', 'mean operative time, radiation time, mean bone union time, or total complication rate', 'operative and radiation time, range of motion, grip strength, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, Visual Analog Scale (VAS) scores, and complications']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0224263', 'cui_str': 'Structure of pronator quadratus muscle'}, {'cui': 'C1261209', 'cui_str': 'Transverse incision'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0224264', 'cui_str': 'Structure of brachioradialis muscle'}, {'cui': 'C1444777', 'cui_str': 'Splitting sensation quality'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",110.0,0.0516226,"There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Yun-Qiang', 'Initials': 'YQ', 'LastName': 'Zhuang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Gang-Qiang', 'Initials': 'GQ', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Ya-Di', 'Initials': 'YD', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}]",The Journal of international medical research,['10.1177/0300060519893851']
1240,31611612,Nationwide randomised trial evaluating elective neck dissection for early stage oral cancer (SEND study) with meta-analysis and concurrent real-world cohort.,"BACKGROUND


Guidelines remain unclear over whether patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END), particularly those with the smallest tumours.
METHODS


We conducted a randomised trial of patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END. Data were also collected from a concurrent cohort of patients who had their preferred surgery. Endpoints included overall survival (OS) and disease-free survival (DFS). We conducted a meta-analysis of all six randomised trials.
RESULTS


Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals). Occult neck disease was found in 19.1% (T1) and 34.7% (T2) patients respectively. Five-year intention-to-treat hazard ratios (HR) were: OS HR = 0.71 (p = 0.18), and DFS HR = 0.66 (p = 0.04). Corresponding per-protocol results were: OS HR = 0.59 (p = 0.054), and DFS HR = 0.56 (p = 0.007). END was effective for small tumours. END patients experienced more facial/neck nerve damage; QoL was largely unaffected. The observational cohort supported the randomised findings. The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001).
CONCLUSION


SEND and the cumulative evidence show that within a generalisable setting oral cancer patients who have an upfront END have a lower risk of death/recurrence, even with small tumours.
CLINICAL TRIAL REGISTRATION


NIHR UK Clinical Research Network database ID number: UKCRN 2069 (registered on 17/02/2006), ISCRTN number: 65018995, ClinicalTrials.gov Identifier: NCT00571883.",2019,"The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001).
","['Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals', 'patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END', 'patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END']",['elective neck dissection'],"['overall survival (OS) and disease-free survival (DFS', 'facial/neck nerve damage; QoL', 'Occult neck disease', 'risk of death/recurrence']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026640', 'cui_str': 'Neoplasm of mouth'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0558385', 'cui_str': 'Disorder of neck'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0161479', 'cui_str': 'Nerve injury'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0558385', 'cui_str': 'Disorder of neck'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.620858,"The meta-analysis produced HR OS 0.64 and DFS 0.54 (p < 0.001).
","[{'ForeName': 'Iain L', 'Initials': 'IL', 'LastName': 'Hutchison', 'Affiliation': 'Barts Health NHS Trust, London, UK. hutch.london@googlemail.com.'}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Ridout', 'Affiliation': 'Saving Faces-The Facial Surgery Research Foundation, London, UK.'}, {'ForeName': 'Sharon M Y', 'Initials': 'SMY', 'LastName': 'Cheung', 'Affiliation': 'Saving Faces-The Facial Surgery Research Foundation, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Barking, Havering and Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hardee', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Surwald', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Janavikulam', 'Initials': 'J', 'LastName': 'Thiruchelvam', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Tim K', 'Initials': 'TK', 'LastName': 'Mellor', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Brennan', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baldwin', 'Affiliation': 'The Pennine Acute Hospitals NHS Trust, England, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Shaw', 'Affiliation': 'Aintree University Hospital NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Halfpenny', 'Affiliation': 'Royal Free London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Danford', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Whitley', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""St George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Malcolm W', 'Initials': 'MW', 'LastName': 'Bailey', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Woodwards', 'Affiliation': 'The Pennine Acute Hospitals NHS Trust, England, UK.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'University Hospital of South Manchester NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McManners', 'Affiliation': 'NHS Forth Valley, Stirling, UK.'}, {'ForeName': 'Chi-Hwa', 'Initials': 'CH', 'LastName': 'Chan', 'Affiliation': 'Luton and Dunstable Hospital NHS Foundation Trust, Luton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Prav', 'Initials': 'P', 'LastName': 'Praveen', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Camilleri', 'Affiliation': 'East and North Hertfordshire NHS Trust, Stevenage, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Avery', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Putnam', 'Affiliation': 'North Cumbria University Hospitals NHS Trust, Carlisle, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Derby Teaching Hospitals NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Webster', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Smith', 'Affiliation': 'Northampton General Hospital NHS Trust, Northampton, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Edge', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McVicar', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Grew', 'Affiliation': 'The Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Hislop', 'Affiliation': 'NHS Ayrshire & Arran, Kilmarnock, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kalavrezos', 'Affiliation': 'University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Martin', 'Affiliation': 'City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'University College London, Cancer Research UK & UCL Cancer Trials Centre, London, UK.'}]",British journal of cancer,['10.1038/s41416-019-0587-2']
1241,32513480,The efficacy of early postoperative enteral immunonutrition on T-lymphocyte count: A randomised control study in low-risk cardiac surgery patients.,"BACKGROUND


Patients undergoing cardiac surgery have a pronounced immune response that leads to a reduction in cellular immunity. Immune-modulating nutritional supplements are considered to be beneficial for patients undergoing major surgery. However, due to the lack of studies in the cardiac surgery population, the effect of immunonutrition remains unclear in this patient group.
OBJECTIVE


Our purpose was to research the efficacy of early postoperative enteral immunonutrition on T-lymphocyte count in the cardiac surgery population.
METHODS


This was a randomised control study of low operative risk adult patients, who underwent elective cardiac surgery. These patients were randomised into immunonutrition and control groups. The immunonutrition group was supplemented with immune nutrients for five postoperative days. The counts of T-lymphocytes, as well as the counts for the CD4+ and CD8+ cell subpopulations were determined on the day of surgery and on the sixth postoperative day.
RESULTS


Fifty-five patients were enrolled in the study, the mean age was 69.7 ± 6.3 years, 28 (50.9%) of them were males, the median operative risk was 1.75%. Twenty-seven (49.1%) were randomised into the immunonutrition group. The control and the immunonutrition groups were similar before the intervention. The counts of the CD3+ T cells and CD4+ T cells on the sixth postoperative day were significantly higher in the immunonutrition group compared to the control group with 1.42 ± 0.49 vs. 1.12 ± 0.56 (∗10 9 /l), p = 0.035 and 1.02 ± 0.36 vs. 0.80 ± 0.43 (∗10 9 /l), p = 0.048, respectively. Regression analysis was performed to determine the efficacy of the immunonutrition on the counts of the CD3+ and CD4+ T cells; CD3+ T and CD4+ T cell counts were increased to 0.264 (∗10 9 /l), p = 0.039 and 0.232 (∗10 9 /l), p = 0.021, respectively.
CONCLUSIONS


Early postoperative immunonutrition increases the count of the CD3+ and CD4+ T cells in cardiac surgical patients. Clinical trials identifier number: NCT04047095.",2020,The counts of the CD3+ T cells and CD4+ T cells on the sixth postoperative day were significantly higher in the immunonutrition group compared to the control group with 1.42 ± 0.49 vs. 1.12 ± 0.56,"['Twenty-seven (49.1', 'patients undergoing major surgery', 'cardiac surgery population', 'low operative risk adult patients, who underwent elective cardiac surgery', 'cardiac surgical patients', 'Patients undergoing cardiac surgery', 'low-risk cardiac surgery patients', 'Fifty-five patients were enrolled in the study, the mean age was 69.7\xa0±\xa06.3 years, 28 (50.9%) of them were males']","['Immune-modulating nutritional supplements', 'early postoperative enteral immunonutrition']","['counts of T-lymphocytes, as well as the counts for the CD4+ and CD8+ cell subpopulations', 'counts of the CD3+ and CD4+ T cells; CD3+ T and CD4+ T cell counts', 'count of the CD3+ and CD4+ T cells', 'counts of the CD3+ T cells and CD4+ T cells', 'median operative risk', 'T-lymphocyte count']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}]","[{'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C4316924', 'cui_str': 'CD8+ cell'}, {'cui': 'C1257890', 'cui_str': 'Group'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1167909', 'cui_str': 'T lymphocyte count'}]",55.0,0.043517,The counts of the CD3+ T cells and CD4+ T cells on the sixth postoperative day were significantly higher in the immunonutrition group compared to the control group with 1.42 ± 0.49 vs. 1.12 ± 0.56,"[{'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Svetikiene', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: marija.svetikiene@santa.lt.'}, {'ForeName': 'Donata', 'Initials': 'D', 'LastName': 'Ringaitiene', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: donata.ringaitiene@santa.lt.'}, {'ForeName': 'Jevgenija', 'Initials': 'J', 'LastName': 'Vezeliene', 'Affiliation': 'Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: jevgenija.vezeliene@santa.lt.'}, {'ForeName': 'Viktoras', 'Initials': 'V', 'LastName': 'Isajevas', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: viktoras.isajevas@santa.lt.'}, {'ForeName': 'Dainius', 'Initials': 'D', 'LastName': 'Trybe', 'Affiliation': 'Faculty of Medicine, Vilnius University, Vilnius, Lithuania. Electronic address: trybe.dainus@gmail.com.'}, {'ForeName': 'Vaidas', 'Initials': 'V', 'LastName': 'Vicka', 'Affiliation': 'Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania; Faculty of Medicine, Vilnius University, Vilnius, Lithuania. Electronic address: vaidas555@gmail.com.'}, {'ForeName': 'Radvile', 'Initials': 'R', 'LastName': 'Malickaite', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania. Electronic address: radvile.malickaite@santa.lt.'}, {'ForeName': 'Laimute', 'Initials': 'L', 'LastName': 'Jurgauskiene', 'Affiliation': 'Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania. Electronic address: laimute.jurgauskiene@santa.lt.'}, {'ForeName': 'Jolita', 'Initials': 'J', 'LastName': 'Norkuniene', 'Affiliation': 'Department of Mathematical Statistics, Faculty of Fundamental Sciences, Vilnius Gediminas Technical University, Vilnius, Lithuania. Electronic address: j.norkuniene1@gmail.com.'}, {'ForeName': 'Mindaugas', 'Initials': 'M', 'LastName': 'Serpytis', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: mindaugas.serpytis@santa.lt.'}, {'ForeName': 'Jurate', 'Initials': 'J', 'LastName': 'Sipylaite', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania; Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Electronic address: jurate.sipylaite@santa.lt.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.009']
1242,32524934,"Examining child intake frequency, mothers' own liking and child early exposure as potential predictors of child liking for restricted foods and drinks at 5 years old.","OBJECTIVE


To examine longitudinal patterns of child introduction to foods and drinks targeted for restriction by parents and associations between child intake frequency, mother's own liking, child early exposure and child liking for restricted foods and drinks at 5 years old.
DESIGN


The study involved secondary analyses of longitudinal data from mothers and children participating in the NOURISH randomised controlled trial. Patterns of descriptive data were examined, and a binary logistic regression model tested for prediction of child liking of a selection of restricted foods and drinks.
SETTING


Brisbane and Adelaide, Australia.
PARTICIPANTS


Two hundred and eleven mothers and their first born 5-year-old children.
RESULTS


The proportion of children who had tried the selected restricted foods and drinks progressively increased from 14 months to 5 years old. Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old. Child high intake frequency at 5 years old also predicted child high liking for sweet foods and drinks, but child early exposure did not predict child liking for the restricted items examined.
CONCLUSIONS


These results challenge the belief that limiting children's intake of foods high in sugar, fat and/or salt will increase their liking for them. Findings instead suggest that restricting children's access to such foods may be beneficial. While further research is required, mothers should be made aware that their own food preferences may inadvertently influence their child's liking for the very foods they are trying to restrict.",2020,Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old.,"['Two hundred and eleven mothers and their first born 5-year-old children', 'Brisbane and Adelaide, Australia', 'mothers and children participating in the NOURISH randomised controlled trial']",[],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],211.0,0.0156282,Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old.,"[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland4059, Australia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jansen', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland4059, Australia.'}, {'ForeName': 'Kimberley M', 'Initials': 'KM', 'LastName': 'Mallan', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.'}]",Public health nutrition,['10.1017/S1368980020000312']
1243,32526195,"Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial.","BACKGROUND


Baloxavir marboxil (hereafter baloxavir), a selective inhibitor of influenza cap-dependent endonuclease, was approved in 2018 in the USA and Japan for the treatment of uncomplicated influenza in otherwise healthy individuals aged 12 years and older. We aimed to study the efficacy of baloxavir in outpatients at high risk of developing influenza-associated complications.
METHODS


We did a double-blind, placebo-controlled and oseltamivir-controlled trial in outpatients aged 12 years and older in 551 sites in 17 countries and territories. Eligible patients had clinically diagnosed influenza-like illness, at least one risk factor for influenza-associated complications (eg, age older than 65 years), and a symptom duration of less than 48 h. Patients were stratified by baseline symptom score (≤14 vs ≥15), pre-existing and worsened symptoms at onset of illness compared with pre-influenza (yes or no), region (Asia, North America and Europe, or southern hemisphere), and weight (<80 kg vs ≥80 kg), and randomly assigned (1:1:1) via an interactive web-response system to either a single weight-based dose of baloxavir (40 mg for patients weighing <80 kg and 80 mg for patients weighing ≥80 kg; baloxavir group), oseltamivir 75 mg twice daily for 5 days (oseltamivir group), or matching placebo (placebo group). All patients, investigators, study personnel, and data analysts were masked to treatment assignment until database lock. The primary endpoint was time to improvement of influenza symptoms (TTIIS) in the modified intention-to-treat population, which included all patients who received at least one dose of study drug and had RT-PCR-confirmed influenza virus infection. Safety was assessed in all patients who receved at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT02949011.
FINDINGS


2184 patients were enrolled from Jan 11, 2017, to March 30, 2018, and randomly assigned to receive baloxavir (n=730), placebo (n=729), or oseltamivir (n=725). The modified intention-to-treat population included 1163 patients: 388 in the baloxavir group, 386 in the placebo group, and 389 in the oseltamivir group. 557 (48%) of 1163 patients had influenza A H3N2, 484 (42%) had influenza B, 80 (7%) had influenza A H1N1, 14 patients had a mixed infection, and 28 had infections with non-typable viruses. The median TTIIS was shorter in the baloxavir group (73·2 h [95% CI 67·2 to 85·1]) than in the placebo group (102·3 h [92·7 to 113·1]; difference 29·1 h [95% CI 14·6 to 42·8]; p<0·0001). The median TTIIS in the oseltamivir group was 81·0 h (95% CI 69·4 to 91·5), with a difference from the baloxavir group of 7·7 h (-7·9 to 22·7). Adverse events were reported in 183 (25%) of 730 patients in the baloxavir group, 216 (30%) of 727 in the placebo group, and 202 (28%) of 721 in the oseltamivir group. Serious adverse events were noted in five patients in the baloxavir group, nine patients in the placebo group, and eight patients in the oseltamivir group; one case each of hypertension and nausea in the placebo group and two cases of transaminase elevation in the oseltamivir group were considered to be treatment related. Polymerase acidic protein variants with Ile38Thr, Ile38Met, or Ile38Asn substitutions conferring reduced baloxavir susceptibility emerged in 15 (5%) of 290 baloxavir recipients assessed for amino acid substitutions in the virus.
INTERPRETATION


Single-dose baloxavir has superior efficacy to placebo and similar efficacy to oseltamivir for ameliorating influenza symptoms in high-risk outpatients. The safety of baloxavir was comparable to placebo. This study supports early therapy for patients at high risk of complications of influenza to speed clinical recovery and reduce complications.
FUNDING


Shionogi.",2020,The median TTIIS was shorter in the baloxavir group (73·2 h [95% CI 67·2 to 85·1]) than in the placebo group (102·3 h [92·7 to 113·1]; difference 29·1 h [95% CI 14·6 to 42·8]; p<0·0001).,"['outpatients at high risk of developing influenza-associated complications', '1163 patients: 388 in the baloxavir group, 386 in the placebo group, and 389 in the oseltamivir group', 'Eligible patients had clinically diagnosed influenza-like illness, at least one risk factor for influenza-associated complications (eg, age older than 65 years), and a symptom duration of less than 48 h. Patients were stratified by baseline symptom score (≤14 vs ≥15), pre-existing and worsened symptoms at onset of illness compared with pre-influenza (yes or no), region (Asia, North America and Europe, or southern hemisphere), and weight (<80 kg vs ≥80 kg', 'n=729), or oseltamivir (n=725', '14 patients had a mixed infection, and 28 had infections with non-typable viruses', 'otherwise healthy individuals aged 12 years and older', '557 (48%) of 1163 patients had influenza A H3N2, 484 (42%) had influenza B, 80 (7', 'outpatients aged 12 years and older in 551 sites in 17 countries and territories', 'high-risk outpatients', 'patients at high risk of complications of influenza to speed clinical recovery and reduce complications', 'patients who receved at least one dose of study drug', 'high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2', '2184 patients were enrolled from Jan 11, 2017, to March 30, 2018']","['placebo-controlled and oseltamivir', 'interactive web-response system to either a single weight-based dose of baloxavir', 'oseltamivir', 'baloxavir', 'oseltamivir 75 mg twice daily for 5 days (oseltamivir group), or matching placebo (placebo', 'baloxavir marboxil', 'Baloxavir marboxil (hereafter baloxavir', 'placebo']","['Safety', 'Adverse events', 'baloxavir susceptibility', 'median TTIIS', 'hypertension and nausea', 'safety of baloxavir', 'time to improvement of influenza symptoms (TTIIS', 'transaminase elevation', 'Serious adverse events']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517752', 'cui_str': '389'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0276353', 'cui_str': 'Influenza due to Influenza B virus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C1126043', 'cui_str': 'Oseltamivir 75 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",2184.0,0.618107,The median TTIIS was shorter in the baloxavir group (73·2 h [95% CI 67·2 to 85·1]) than in the placebo group (102·3 h [92·7 to 113·1]; difference 29·1 h [95% CI 14·6 to 42·8]; p<0·0001).,"[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Ison', 'Affiliation': 'Divisions of Infectious Diseases and Organ Transplantation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. Electronic address: mgison@northwestern.edu.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Portsmouth', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Shishido', 'Affiliation': 'Shionogi and Company, Osaka, Japan.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mitchener', 'Affiliation': 'Shionogi, Florham Park, NJ, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': 'Shionogi and Company, Osaka, Japan.'}, {'ForeName': 'Takeki', 'Initials': 'T', 'LastName': 'Uehara', 'Affiliation': 'Shionogi and Company, Osaka, Japan.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, VA, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30004-9']
1244,32533314,"Randomized controlled trial of landiolol, a short-acting beta-1 adrenergic receptor blocker, illustrating changes in high-molecular weight adiponectin levels after elective percutaneous coronary intervention.","Adiponectin (APN) has cardioprotective properties and bisoprolol has been reported to increase myocardial APN expression and reduce myocardial damage. Administration of landiolol, which has a higher cardio-selectivity and shorter half-life than bisoprolol, during the percutaneous coronary intervention (PCI) may increase serum APN and high-molecular weight (HMW)-APN, an active form of APN, in patients with stable angina pectoris (SAP). We recruited 70 patients with SAP and randomized them to intravenous landiolol during PCI (N = 35) or control group (N = 35). The primary endpoint was serum APN and HMW-APN level 3 days after PCI. There was no difference in the primary endpoint between the landiolol and control groups (8.93 ± 5.24 vs. 10.18 ± 5.81 μg/mL, p = 0.35 and 3.36 ± 2.75 vs. 4.28 ± 3.13 μg/mL, p = 0.20) for APN and HMW-APN levels, respectively. APN and HMW-APN level were significantly decreased 1 day after PCI [-0.55 ± 0.92 μg/mL (9.87-9.32 μg/mL), p < 0.001 and -0.20 ± 0.45 μg/mL (3.89-3.69 μg/mL), p < 0.001, respectively]. Additionally, the absolute change in HMW-APN was significantly smaller in the landiolol group compared to the control group (-0.08 ± 0.27 vs. -0.31 ± 0.55 μg/mL, p = 0.031). Multiple linear regression analysis showed that use of landiolol was an independent predictor of change in HMW-APN (β = 0.276, p = 0.014). Serum APN and HMW-APN level 3 days after PCI were similar between patients treated with and without landiolol. APN and HMW-APN decreased 1 day after PCI in the SAP and landiolol mitigated decrease in HMW-APN.",2020,Serum APN and HMW-APN level 3 days after PCI were similar between patients treated with and without landiolol.,"['70 patients with SAP and randomized them to', 'elective percutaneous coronary intervention', 'patients with stable angina pectoris (SAP']","['percutaneous coronary intervention (PCI', 'Adiponectin (APN', 'intravenous landiolol during PCI (N\u2009=\u200935) or control group', 'mL', 'landiolol']","['myocardial APN expression and reduce myocardial damage', 'HMW-APN (β', 'APN and HMW-APN level', 'HMW-APN', 'Serum APN and HMW-APN level', 'absolute change in HMW-APN', 'APN and HMW-APN', 'serum APN and HMW-APN level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C2733715', 'cui_str': 'High molecular weight adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",70.0,0.162417,Serum APN and HMW-APN level 3 days after PCI were similar between patients treated with and without landiolol.,"[{'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Kiyokuni', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Konishi', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan. m_koni@hotmail.com.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Saigusa', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kiwamu', 'Initials': 'K', 'LastName': 'Iwata', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nakayama', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Komura', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Teruyasu', 'Initials': 'T', 'LastName': 'Sugano', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Ishigami', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kouichi', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.'}]",Heart and vessels,['10.1007/s00380-020-01637-6']
1245,32533332,"Comparison of the ultrasound-guided single-injection femoral triangle block versus adductor canal block for analgesia following total knee arthroplasty: a randomized, double-blind trial.","PURPOSE


The aim of the study is to compare the femoral triangle (FT) and adductor canal (AC) blocks in terms of the analgesic efficacy and ambulatory outcomes in the context of multimodal analgesia following total knee arthroplasty (TKA).
METHODS


Patients presenting for TKA were assigned to a preoperative ultrasound-guided single-injection FT or AC block. Combined spinal and epidural anesthesia with bupivacaine was administered for TKA. Perioperatively a multimodal analgesic regimen was applied up to 48 h after surgery. The primary outcome was the average pain score during movement in the first 24 h postoperatively. The secondary outcomes included pain scores at rest and during movement at postoperative predetermined time points, cumulative opioid consumption in oral morphine equivalents, functional mobility measured by the timed ""Up and Go"" (TUG) test and muscle strength in the lower extremity.
RESULTS


Ninety-eight patients completed the study. Patients in the FT group had lower median pain scores during movement in the first 24 h postoperatively than those in the AC group (1.3 [1.0-3.3] vs. 3.0 [1.7-4.3]; median difference: - 1.0, adjusted 95% CI from - 1.7 to - 0.3, P = 0.010). There were significant differences in the pain scores at rest and during movement at 12 and 24 h postoperatively between the two groups (P = 0.008 and 0.005, respectively). Cumulative oral morphine equivalent consumption in the first and second 24 h postoperatively, Functional mobility reflected by the TUG test and muscle strength in the lower extremity showed no significantly statistically differences between the two groups.
CONCLUSIONS


The preoperative FT block provided improved analgesic outcomes without compromising functional mobility in the context of multimodal analgesia following TKA compared with the AC block.
TRIAL REGISTRATION


https://www.chictr.org.cn . Identifier: ChiCTR-INR-17012716.",2020,"There were significant differences in the pain scores at rest and during movement at 12 and 24 h postoperatively between the two groups (P = 0.008 and 0.005, respectively).","['total knee arthroplasty', 'total knee arthroplasty (TKA', 'Ninety-eight patients completed the study', 'Patients presenting for TKA']","['preoperative ultrasound-guided single-injection FT or AC block', 'ultrasound-guided single-injection femoral triangle block versus adductor canal block', 'femoral triangle (FT) and adductor canal (AC) blocks', 'bupivacaine']","['pain scores', 'median pain scores', 'pain scores at rest and during movement at postoperative predetermined time points, cumulative opioid consumption in oral morphine equivalents, functional mobility measured by the timed ""Up and Go"" (TUG) test and muscle strength in the lower extremity', 'average pain score', 'Cumulative oral morphine equivalent consumption', 'TUG test and muscle strength']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0225265', 'cui_str': 'Femoral triangle structure'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",98.0,0.178078,"There were significant differences in the pain scores at rest and during movement at 12 and 24 h postoperatively between the two groups (P = 0.008 and 0.005, respectively).","[{'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 15, Xishiku Street, Beijing, 100034, China. songlinlinlynkia@163.com.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 15, Xishiku Street, Beijing, 100034, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 15, Xishiku Street, Beijing, 100034, China.'}, {'ForeName': 'Zhi-Yu', 'Initials': 'ZY', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 15, Xishiku Street, Beijing, 100034, China.'}, {'ForeName': 'Dong-Xin', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 15, Xishiku Street, Beijing, 100034, China.'}]",Journal of anesthesia,['10.1007/s00540-020-02813-8']
1246,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM


This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG).
METHODS


Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test.
RESULTS


Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05).
CONCLUSIONS


It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572']
1247,32524827,An integrated videoconferencing intervention for chronic pain and heavy drinking among patients in HIV-care: a proof-of-concept study.,"Chronic pain and heavy drinking are common comorbid conditions among people living with HIV/AIDS (PLWHA). An integrated approach to address these co-occurring conditions in a manner that facilitates treatment utilization would represent an important advance in HIV-care. This study examined the acceptability and feasibility of a tailored, videoconferencing intervention to reduce chronic pain and heavy drinking among PLWHA. Participants in HIV-care (n = 8) completed baseline assessments and an in-person intervention session followed by 6 videoconferencing sessions. Acceptability and feasibility were assessed with patient satisfaction ratings and interview responses 8 weeks following baseline along with videoconferencing use during the intervention period. Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format. All participants successfully enabled videoconferencing on their own smartphones and completed a median number of 4.5 (out of 6) video-sessions. Changes in heavy drinking and pain provided additional support for the potential utility of this approach. Results suggest that this videoconferencing intervention is an acceptable and feasible method of addressing chronic pain and heavy drinking among PLWHA. Findings provide the basis for future work to examine the efficacy of this approach in a Stage 1b trial.",2020,"Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format.","['patients in HIV-care', 'Participants in HIV-care (n\u2009=\u20098) completed', 'people living with HIV/AIDS (PLWHA']","['integrated videoconferencing intervention', 'baseline assessments and an in-person intervention session followed by 6 videoconferencing sessions', 'videoconferencing intervention']","['Acceptability and feasibility', 'chronic pain and heavy drinking', 'Chronic pain and heavy drinking', 'Treatment satisfaction and comprehensibility ratings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0421099,"Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format.","[{'ForeName': 'Tibor P', 'Initials': 'TP', 'LastName': 'Palfai', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saitz', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Maya P L', 'Initials': 'MPL', 'LastName': 'Kratzer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Otis', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}]",AIDS care,['10.1080/09540121.2020.1776825']
1248,32530426,Pay-it-forward gonorrhoea and chlamydia testing among men who have sex with men in China: a randomised controlled trial.,"BACKGROUND


WHO recommends that men who have sex with men (MSM) receive gonorrhoea and chlamydia testing, but many evidence-based preventive services are unaffordable. The pay-it-forward strategy offers an individual a gift (eg, a test for sexually transmitted diseases) and then asks whether they would like to give a gift (eg, a future test) to another person. This study examined the effectiveness of a pay-it-forward programme to increase gonorrhoea and chlamydia testing among MSM in China.
METHODS


We did a randomised controlled superiority trial at three HIV testing sites run by MSM community-based organisations in Guangzhou and Beijing, China. We included MSM aged 16 years or older who were seeking HIV testing and met indications for gonorrhoea and chlamydia testing. Restricted randomisation was done using computer-generated permuted blocks. 30 groups were randomised into three arms (1:1:1): a pay-it-forward arm in which men were offered free gonorrhoea and chlamydia testing and then asked whether they would like to donate for testing of prospective participants, a pay-what-you-want arm in which men were offered free testing and given the option to pay any desired amount for the test, and a standard-of-care arm in which testing was offered at ¥150 (US$22). There was no masking to arm assignment. The primary outcome was gonorrhoea and chlamydia test uptake ascertained by administrative records. We used generalised estimating equations to estimate intervention effects with one-sided 95% CIs and a prespecified superiority margin of 20%. The trial is registered with ClinicalTrials.gov, NCT03741725.
FINDINGS


Between Dec 8, 2018, and Jan 19, 2019, 301 men were recruited and included in the analysis. 101 were randomly assigned to the pay-it-forward group, 100 to the pay-what-you-want group, and 100 to the standard-of-care group. Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm. The estimated difference in test uptake between the pay-it-forward and standard-of-care group was 38·4% (95% CI lower bound 28·4%). Among men in the pay-it-forward arm, 54 of 57 (95%) chose to donate to support testing for others.
INTERPRETATION


The pay-it-forward strategy can increase gonorrhoea and chlamydia testing uptake among Chinese MSM and could be a useful tool for scaling up preventive services that carry a mandatory fee.
FUNDING


US National Institute of Health; Special Programme for Research and Training in Tropical Diseases, sponsored by UNICEF, UNDP, World Bank, and WHO; the National Key Research and Development Program of China; Doris Duke Charitable Foundation; and Social Entrepreneurship to Spur Health.",2020,"Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm.","['MSM aged 16 years or older who were seeking HIV testing and met indications for gonorrhoea and chlamydia testing', 'men who have sex with men in China', 'MSM in China', 'three HIV testing sites run by MSM community-based organisations in Guangzhou and Beijing, China', 'Between Dec 8, 2018, and Jan 19, 2019, 301 men were recruited and included in the analysis', 'men who have sex with men (MSM']","['pay-it-forward arm in which men were offered free gonorrhoea and chlamydia testing', 'pay-it-forward group, 100 to the pay-what-you-want group, and 100 to the standard-of-care group', 'Pay-it-forward gonorrhoea and chlamydia testing', 'pay-it-forward programme', 'pay-what-you-want arm in which men were offered free testing and given the option to pay any desired amount for the test, and a standard-of-care arm in which testing']",['gonorrhoea and chlamydia test uptake'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]","[{'cui': 'C0018081', 'cui_str': 'Gonorrhea'}, {'cui': 'C0008148', 'cui_str': 'Chlamydia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",301.0,0.098425,"Test uptake for gonorrhoea and chlamydia was 56% (57 of 101 participants) in the pay-it-forward arm, 46% (46 of 100 participants) in the pay-what-you-want arm, and 18% (18 of 100 participants) in the standard-of-care arm.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China; University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Tiange P', 'Initials': 'TP', 'LastName': 'Zhang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; Loyola University Chicago Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China; University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Ong', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, VIC, Australia; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Forastiere', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA; Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Li', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zou', 'Affiliation': 'Department of Biostatistics, University of North Carolina at Chapel Hill, NC, USA.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Mi', 'Affiliation': 'Blued, Beijing, China.'}, {'ForeName': 'Yehua', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China.'}, {'ForeName': 'Weizan', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Zhitong Guangzhou LGBT Center, Guangzhou, China.'}, {'ForeName': 'Danyang', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Zhitong Guangzhou LGBT Center, Guangzhou, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vickerman', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Christakis', 'Affiliation': 'Yale Institute for Network Science, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina at Chapel Hill, Project-China, Guangzhou, China; London School of Hygiene and Tropical Medicine, London, UK. Electronic address: jdtucker@med.unc.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30172-9']
1249,32538182,Vitamin D levels in IBD: a randomised trial of weight-based versus fixed dose vitamin D supplementation.,"Objectives:  Body weight is one of the factors affecting blood levels of 25-hydroxyvitamin D (25OHD). The aim of this study was to establish whether a vitamin D (vitD) weight-based dosing is more appropriate to a fixed daily dose in patients with inflammatory bowel disease (IBD). Materials/methods:  This was an open label randomised trial. Patients with IBD were assigned to receive oral cholecalciferol at a dose of 28 IU/kg (IU/kg) or 2000 IU per day (IU/day) for 12 weeks during winter months. 25OHD plasma levels and other biochemical parameters were measured at baseline and after supplementation period. The primary outcome measure was 25OHD level after a follow-up period. Results:  A total of 173 patients were analysed. The mean BMI was 25.5 ± 5.1 and initial mean 25OHD level was 62.7 ± 25.5 nmol/l. A similar increase (9.7 ± 26.9 vs 9.8 ± 26.7 nmol/l) in 25OHD levels occurred both in IU/kg and IU/day group. The proportion of subjects with normal and sub-normal levels following the substitution was comparable irrespective of body weight. The change in 25OHD level correlated positively only with the dose of vitD ( p  < .001) and negatively with the baseline 25OHD level ( p  < .001). A sustained 25OHD level of 75 nmol/l corresponds with a calculated daily vitD dose of 2034 IU. Conclusions:  Weight-based dosing of vitamin D is not superior to a fixed dose in order to maintain stable 25OHD levels in IBD patients. Cholecalciferol dose of 2,000 IU/day is safe and sufficient during winter period.",2020,The change in 25OHD level correlated positively only with the dose of vitD ( p  < .001) and negatively with the baseline 25OHD level ( p  < .001).,"['IBD', 'A total of 173 patients were analysed', 'IBD patients', 'patients with inflammatory bowel disease (IBD', 'Patients with IBD']","['weight-based versus fixed dose vitamin D supplementation', 'Cholecalciferol', 'vitamin D (vitD) weight-based dosing', 'vitamin D', 'oral cholecalciferol']","['change in 25OHD level', '25OHD levels', '25OHD plasma levels', 'baseline 25OHD level', 'blood levels of 25-hydroxyvitamin D (25OHD', 'mean BMI', 'initial mean 25OHD level', '25OHD level', 'Vitamin D levels']","[{'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",173.0,0.398191,The change in 25OHD level correlated positively only with the dose of vitD ( p  < .001) and negatively with the baseline 25OHD level ( p  < .001).,"[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Kojecky', 'Affiliation': 'Faculty of Medicine, Masaryk University Brno, Brno, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Matous', 'Affiliation': '2nd Department of Internal Medicine, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Kianicka', 'Affiliation': '2nd Department of Internal Medicine/Department of Gastroenterology, St. Anne´s University Hospital, Brno, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Dite', 'Affiliation': 'Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Zdena', 'Initials': 'Z', 'LastName': 'Zadorova', 'Affiliation': '2nd Department of Internal Medicine, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kubovy', 'Affiliation': 'Department of Gastroenterology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Hlostova', 'Affiliation': 'Institute of Health Information and Statistics of the Czech Republic, Prague, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Uher', 'Affiliation': 'Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2020.1774921']
1250,32541548,The Impact of an Optimism Training Intervention on Biological Measures Associated With Cardiovascular Health: Data From a Randomized Controlled Trial.,"OBJECTIVE


Positive psychological constructs, such as optimism, are associated with cardiovascular health, and changes in biological measures associated with heart health have been proposed as potential mediators of these relationships. In this analysis of data from a randomized controlled trial, we examined the impact of an optimism training intervention on biological measures associated with cardiac health in patients with coronary artery disease.
METHODS


We analyzed data from an 8-week, randomized, controlled trial of a group-based optimism training intervention in 61 patients with coronary artery disease. High-sensitivity C-reactive protein (hs-CRP), interleukin 6, irisin, and fibrinogen were measured at baseline, 8 weeks, and 16 weeks. Mixed-effects regression analyses were performed to examine the effects of the intervention on changes in biological measures at 8 and 16 weeks.
RESULTS


At 8 weeks, the intervention led to significantly greater reductions in hs-CRP (B = -0.851 [standard error {SE} = 0.273, p = .002) and fibrinogen (B = -0.148 [SE = 0.062], p = .016), and a greater increase in irisin (B = 0.252 [SE = 0.114], p = .027) compared with the control condition. These changes persisted at 16 weeks (hs-CRP: B = -1.078 [SE = 0.276], p < .001; fibrinogen: B = -0.270 [SE = 0.062], p < .001; irisin: B = 0.525 [SE = 0.116], p < .001), and interleukin 6 additionally was impacted at this time point (B = -0.214 [SE = 0.064], p = .001). Exploratory mediation analyses failed to identify significant psychological or health behavior mediators of these relationships.
CONCLUSIONS


A group-based optimism training intervention resulted in significant, robust, and sustained changes in biological measures associated with cardiac health. Further studies are needed to confirm these findings in a larger sample and identify potential mediating variables.
TRIAL REGISTRATION


Iran Registry of Clinical Trials No. 2016070328769 N1.",2020,"At 8 weeks, the intervention led to significantly greater reductions in hs-CRP (B=-0.851 [standard error (SE)=0.273], p=.002) and fibrinogen (B=-0.148 [SE=0.062], p=.016), and a greater increase in irisin (B=0.252 [SE=0.114], p=.027), than the control condition.","['61 patients with CAD', 'patients with coronary artery disease (CAD']","['optimism training intervention', 'IRCT']","['irisin', 'fibrinogen', 'High sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), irisin, and fibrinogen', 'hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",61.0,0.139647,"At 8 weeks, the intervention led to significantly greater reductions in hs-CRP (B=-0.851 [standard error (SE)=0.273], p=.002) and fibrinogen (B=-0.148 [SE=0.062], p=.016), and a greater increase in irisin (B=0.252 [SE=0.114], p=.027), than the control condition.","[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Mohammadi', 'Affiliation': 'From the Psychosomatic Research Center, Isfahan University of Medical Sciences (Mohammadi), Isfahan, Iran; Department of Psychology (Aghayousefi, Alipour), Payame Noor University, Tehran, Iran; Department of Psychology (Nikrahan), Farhangian University, Tehran, Iran; Department of Psychology (Nikrahan), University of Isfahan, Isfahan, Iran; Harvard Medical School (King, Celano, Huffman), Boston, MA; Department of Psychiatry, Massachusetts General Hospital (King, Celano, Gomez, Huffman), Boston, MA; and Department of Cardiology, Cardiac Rehabilitation Research Center, Isfahan, Iran; (Sadeghi), and Department of Psychiatry, Isfahan Cardiovascular Research Center, Isfahan, Iran; (Roohafza), Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Aghayousefi', 'Affiliation': ''}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Nikrahan', 'Affiliation': ''}, {'ForeName': 'Franklin', 'Initials': 'F', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alipour', 'Affiliation': ''}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Sadeghi', 'Affiliation': ''}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Roohafza', 'Affiliation': ''}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': ''}, {'ForeName': 'Perla Romero', 'Initials': 'PR', 'LastName': 'Gomez', 'Affiliation': ''}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000834']
1251,32517165,When Do Good Deeds Lead to Good Feelings? Eudaimonic Orientation Moderates the Happiness Benefits of Prosocial Behavior.,"Engaging in prosocial behavior is considered an effective way to increase happiness in a sustainable manner. However, there is insufficient knowledge about the conditions under which such a happiness effect occurs. From a person-activity congruence perspective, we proposed that an individual's eudaimonic orientation moderates the effect of prosocial behavior on happiness, whereas hedonic orientation does not. For this purpose, 128 participants were assigned to play a game in which half of them were explained the benevolence impact of playing the game (the benevolence condition), and the other half played the same game without this knowledge (the control condition). Participants' eudaimonic and hedonic orientations were assessed before the game, and their post-task happiness were measured after the game. The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition. Furthermore, this happiness effect was moderated by participants' eudaimonic orientation-participants with high eudaimonic orientation reaped greater benefits from benevolence, and their hedonic orientation did not moderate the relationship between benevolence and happiness. The importance of the effect of person-activity congruence on happiness is discussed, along with the implications of these findings for sustainably pursuing happiness.",2020,The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition.,['128 participants'],[],"['eudaimonic and hedonic orientations', 'higher post-task positive affect']",[],[],"[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",128.0,0.0317442,The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition.,"[{'ForeName': 'Weipeng', 'Initials': 'W', 'LastName': 'Lai', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Zhixu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Qionghan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Hezhi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17114053']
1252,32517192,Effect of Magnesium Supplementation on Circulating Biomarkers of Cardiovascular Disease.,"(1) Background: Magnesium supplementation may be effective for the prevention of cardiometabolic diseases, but the mechanisms are unclear. Proteomic approaches can assist in identifying the underlying mechanisms. (2) Methods: We collected repeated blood samples from 52 individuals enrolled in a double-blind trial which randomized participants 1:1 to oral magnesium supplementation (400 mg magnesium/day in the form of magnesium oxide) or a matching placebo for 10 weeks. Plasma levels of 91 proteins were measured at baseline with follow-up samples using the Olink Cardiovascular Disease III proximity extension assay panel and were modeled as arbitrary units in a log 2  scale. We evaluated the effect of oral magnesium supplementation for changes in protein levels and the baseline association between serum magnesium and protein levels. The Holm procedure was used to adjust for multiple comparisons. (3) Results: Participants were 73% women, 94% white, and had a mean age of 62. Changes in proteins did not significantly differ between the two intervention groups after correction for multiple comparisons. The most statistically significant effects were on myoglobin [difference -0.319 log 2  units, 95% confidence interval (CI) (-0.550, -0.088),  p =  0.008], tartrate-resistant acid phosphatase type 5 (-0.187, (-0.328, -0.045),  p =  0.011), tumor necrosis factor ligand superfamily member 13B (-0.181, (-0.332, -0.031),  p =  0.019), ST2 protein (-0.198, (-0.363, -0.032),  p =  0.020), and interleukin-1 receptor type 1 (-0.144, (-0.273, -0.015),  p =  0.029). Similarly, none of the associations of baseline serum magnesium with protein levels were significant after correction for multiple comparisons. (4) Conclusions: Although we did not identify statistically significant effects of oral magnesium supplementation in this relatively small study, this study demonstrates the value of proteomic approaches for the investigation of mechanisms underlying the beneficial effects of magnesium supplementation. Clinical Trials Registration: ClinicalTrials.gov NCT02837328.",2020,"The most statistically significant effects were on myoglobin [difference -0.319 log 2  units, 95% confidence interval (CI) (-0.550, -0.088),  p =  0.008], tartrate-resistant acid phosphatase type 5 (-0.187, (-0.328, -0.045),  p =  0.011), tumor necrosis factor ligand superfamily member 13B (-0.181, (-0.332, -0.031),  p =  0.019), ST2 protein (-0.198, (-0.363, -0.032),  p =  0.020), and interleukin-1 receptor type 1 (-0.144, (-0.273, -0.015),  p =  0.029).","['Participants were 73% women, 94% white, and had a mean age of 62', '52 individuals enrolled']","['Magnesium Supplementation', 'oral magnesium supplementation (400 mg magnesium/day in the form of magnesium oxide) or a matching placebo', 'oral magnesium supplementation', 'Magnesium supplementation']","['Plasma levels of 91 proteins', 'Circulating Biomarkers of Cardiovascular Disease', 'ST2 protein', 'tartrate-resistant acid phosphatase type']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1096534', 'cui_str': 'Magnesium supplement therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0450499', 'cui_str': 'ST2'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",73.0,0.469746,"The most statistically significant effects were on myoglobin [difference -0.319 log 2  units, 95% confidence interval (CI) (-0.550, -0.088),  p =  0.008], tartrate-resistant acid phosphatase type 5 (-0.187, (-0.328, -0.045),  p =  0.011), tumor necrosis factor ligand superfamily member 13B (-0.181, (-0.332, -0.031),  p =  0.019), ST2 protein (-0.198, (-0.363, -0.032),  p =  0.020), and interleukin-1 receptor type 1 (-0.144, (-0.273, -0.015),  p =  0.029).","[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Lin Y', 'Initials': 'LY', 'LastName': 'Chen', 'Affiliation': 'Cardiovascular Division, Department of Medicine, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Rudser', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Faye L', 'Initials': 'FL', 'LastName': 'Norby', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN 55454, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Rooney', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21287, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Lutsey', 'Affiliation': 'Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN 55454, USA.'}]",Nutrients,['10.3390/nu12061697']
1253,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
1254,32524360,Impact of a Preoperative Video-Based Educational Intervention on Postoperative Outcomes in Elective Major Abdominal Surgery: a Randomized Controlled Trial.,,2020,,['Elective Major Abdominal Surgery'],['Preoperative Video-Based Educational Intervention'],['Postoperative Outcomes'],"[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.142779,,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Campagna', 'Affiliation': 'Department of Public Health and Pediatrics, University of Torino, via Santena 5 bis, 10126, Torino, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Clari', 'Affiliation': 'Department of Public Health and Pediatrics, University of Torino, via Santena 5 bis, 10126, Torino, Italy. marco.clari@unito.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Delfino', 'Affiliation': 'Department of Public Health and Pediatrics, University of Torino, via Santena 5 bis, 10126, Torino, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Rolfo', 'Affiliation': 'Ordine Mauriziano Hospital, via Magellano 1, 10128, Torino, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Rizzo', 'Affiliation': 'Ordine Mauriziano Hospital, via Magellano 1, 10128, Torino, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Berchialla', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Torino, via Santena 5 bis, 10126, Torino, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Ferrero', 'Affiliation': 'Ordine Mauriziano Hospital, via Magellano 1, 10128, Torino, Italy.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-020-04667-7']
1255,32541143,A Randomized Phase IIa Trial with Temsirolimus versus Sunitinib in Advanced Non-Clear Cell Renal Cell Carcinoma: An Intergroup Study of the CESAR Central European Society for Anticancer Drug Research-EWIV and the Interdisciplinary Working Group on Renal Cell Cancer (IAGN) of the German Cancer Society.,"BACKGROUND


Non-clear cell renal cell cancers (nccRCC) are rare entities, and the optimal therapy in metastatic disease has still to be defined.
METHODS


In this small prospectively randomized phase IIa multicenter trial, we investigated temsirolimus (TEM) versus sunitinib (SUN) as first-line therapy in patients with metastatic nccRCC. The patients were randomized 1:1 to either TEM in a dose of 25 mg i.v. once a week or SUN with 50 mg p.o. daily for 4 weeks on and 2 weeks off. Primary endpoint was progression-free survival (PFS). In total, 22 patients were included with predominantly papillary RCC (16/22) followed by chromophobe RCC and others.
RESULTS


The male to female ratio was 16:6. The tumor control rate (CR + PR + SD) was 58% for TEM and 90% for SUN-treated patients. There was also a trend for improved PFS with 9.3 versus 13.2 months (HR 1.64; 95% CI 0.65-4.18) in favor of SUN. There was no trend for overall survival.
CONCLUSIONS


Despite this trial had to be terminated earlier due to low recruitment, the results match the other studies published so far with the mTOR inhibitor everolimus and SUN, which show a trend in favor of SUN for ORR and PFS.",2020,The tumor control rate (CR + PR + SD) was 58% for TEM and 90% for SUN-treated patients.,"['patients with metastatic nccRCC', 'Advanced Non-Clear Cell Renal Cell Carcinoma', '22 patients were included with predominantly papillary RCC (16/22) followed by chromophobe RCC and others']","['TEM', 'temsirolimus (TEM) versus sunitinib (SUN', 'Temsirolimus versus Sunitinib']","['progression-free survival (PFS', 'overall survival', 'PFS', 'tumor control rate (CR + PR + SD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0450329', 'cui_str': '16/22'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",22.0,0.176986,The tumor control rate (CR + PR + SD) was 58% for TEM and 90% for SUN-treated patients.,"[{'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Bergmann', 'Affiliation': 'Medical Clinic II, J.W. Goethe University, Frankfurt, Germany, L.Bergmann@em.uni-frankfurt.de.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'Hematology and Medical Oncology, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Luise', 'Initials': 'L', 'LastName': 'Maute', 'Affiliation': 'Medical Clinic II, J.W. Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Clinic for Urology, Friedrich-Schiller University, Jena, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Weikert', 'Affiliation': 'Clinic for Urology, Vivantes Humboldt-Klinikum, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schleicher', 'Affiliation': 'Clinic for Hematology and Oncology, Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Klotz', 'Affiliation': 'Clinic for Urology and Andrology, Kliniken Nordoberpfalz AG, Weiden, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Greiner', 'Affiliation': 'Clinic for Hematology and Oncology, Diakonie Klinikum, Stuttgart, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Flörcken', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Virchow-Klinikum, Berlin, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': 'Institut for Pathology, University Hospital, Erlangen-Nürnberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gauler', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University Hospital Essen of the University Duisburg-Essen, Essen, Germany.'}]",Oncology research and treatment,['10.1159/000508450']
1256,32546239,A prospective longitudinal study on the microbiota composition in amyotrophic lateral sclerosis.,"BACKGROUND


A connection between amyotrophic lateral sclerosis (ALS) and altered gut microbiota composition has previously been reported in animal models. This work is the first prospective longitudinal study addressing the microbiota composition in ALS patients and the impact of a probiotic supplementation on the gut microbiota and disease progression.
METHODS


Fifty patients and 50 matched controls were enrolled. The microbial profile of stool samples from patients and controls was analyzed via PCR-Denaturing Gradient Gel Electrophoresis, and the main microbial groups quantified via qPCR. The whole microbiota was then analyzed via next generation sequencing after amplification of the V3-V4 region of 16S rDNA. Patients were then randomized to receive probiotic treatment or placebo and followed up for 6 months with ALSFRS-R, BMI, and FVC%.
RESULTS


The results demonstrate that the gut microbiota of ALS patients is characterized by some differences with respect to controls, regardless of the disability degree. Moreover, the gut microbiota composition changes during the course of the disease as demonstrated by the significant decrease in the number of observed operational taxonomic unit during the follow-up. Interestingly, an unbalance between potentially protective microbial groups, such as Bacteroidetes, and other with potential neurotoxic or pro-inflammatory activity, such as Cyanobacteria, has been shown. The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
CONCLUSIONS


Our study poses the bases for larger clinical studies to characterize the microbiota changes as a novel ALS biomarker and to test new microbial strategy to ameliorate the health status of the gut.
TRIAL REGISTRATION


CE 107/14, approved by the Ethics Committee of the ""Maggiore della Carità"" University Hospital, Italy.",2020,"The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
","['Fifty patients and 50 matched controls were enrolled', 'amyotrophic lateral sclerosis', 'ALS patients']","['probiotic supplementation', 'probiotic treatment or placebo']","['gut microbial composition', 'gut microbiota composition changes', 'biodiversity of intestinal microbiota']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0282469', 'cui_str': 'Biological Diversity'}]",50.0,0.0171276,"The 6-month probiotic treatment influenced the gut microbial composition; however, it did not bring the biodiversity of intestinal microbiota of patients closer to that of control subjects and no influence on the progression of the disease measured by ALSFRS-R was demonstrated.
","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Di Gioia', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bozzi Cionci', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Baffoni', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Amoruso', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pane', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mogna', 'Affiliation': 'BIOLAB RESEARCH srl, via E. Mattei 3, 28100, Novara, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gaggìa', 'Affiliation': 'Department of Agricultural and Food Sciences, University of Bologna, Viale Fanin 42, Bologna, Italy.'}, {'ForeName': 'Maria Ausiliatrice', 'Initials': 'MA', 'LastName': 'Lucenti', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Bersano', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cantello', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'De Marchi', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Mazzini', 'Affiliation': 'Department of Neurology and ALS Centre, University of Piemonte Orientale, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy. letizia.mazzini@uniupo.it.'}]",BMC medicine,['10.1186/s12916-020-01607-9']
1257,32518060,Guided Self-Help Behavioral Activation Intervention for Geriatric Depression: Protocol for Pilot Randomized Controlled Trial.,"BACKGROUND


Aging is a social concern. The increased incidence of depression in older populations in China poses a challenge to the health care system. Older adults who are depressed often suffer from a lack of motivation. Behavioral activation treatment, an evidence-based guided self-help treatment, is effective in reducing anhedonia and amotivation in depression; however, the efficacy of guided self-help behavioral activation in older adults with depression is not yet known.
OBJECTIVE


The aim of this study is to pilot a self-help guided intervention for the treatment of depression in older adults.
METHODS


This study has been designed as a pilot randomized controlled trial with inpatients (n=60; to be randomly allocated 1:1) between the ages of 60 and 70 and who have major depressive disorder. Patients attending clinical psychological clinics at the Mental Health Center of Chongqing will be randomized to either receive guided self-help behavioral activation (intervention) or to be on a 6-week waiting list (control). Participants in the treatment group will receive 6 sessions of guided self-help behavioral activation delivered over the telephone. The waiting list control group will receive the intervention after a period of 6 weeks. Exclusion criteria will be individuals who are at significant risk of harming themselves or others, who have a primary mental health disorder other than depression, or who have an intellectual disability that would hamper their ability to participate in the intervention. Effects of the treatment will be observed using outcomes in 3 domains: (1) clinical outcomes (symptom severity, recovery rate), (2) process variables (patient satisfaction, attendance, dropout), and (3) economic outcomes (cost and resource use). We will also examine mediators of outcomes in terms of patient variables (behavioral activation or inhibition motivation). We hypothesize that guided self-help behavioral activation will have a beneficial effect.
RESULTS


The study was approved by the research ethics committee of the Mental Health Center of Chongqing in November 2019. As of July 2020, recruitment had not yet begun. Data collection is expected to be completed by December 2020. Data analysis is expected to be completed by June 2021. Results will then be disseminated to patients, to the public, to clinicians, and to researchers through publications in journals and presentations at conferences.
CONCLUSIONS


This will be the first study in China to investigate guided self-help interventions for patients who are older adults and who are depressed, a group which is currently underrepresented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression. The generalizability and broad inclusion criteria are strengths.
TRIAL REGISTRATION


Chinese Clinical Trial Register ChiCTR1900026066; http://www.chictr.org.cn/showprojen.aspx?proj=43548.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/18259.",2020,"RESULTS


Effects of the treatment were observed on three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use).","['geriatric depression', 'Chinese older populations', 'elderly depressed patients', 'China geriatric depressed patients, a group which is currently under-represented in mental health research', 'Participants attending clinical psychological clinics at Mental Health Center of Chongqing', 'elderly patients', '30 elderly inpatients with major depressive disorder', 'Depressed older adults']","['Evidence-based guided self-help behavioral activation (BA) treatment', 'guided self-help interventions', 'guided self-help BA intervention or to a 6-week waiting list control', '6 sessions of guided self-help BA intervention delivered over the telephone', 'guided self-help Behavioral Activation intervention']","['three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",30.0,0.053098,"RESULTS


Effects of the treatment were observed on three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use).","[{'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Basic Psychology, College of Psychology, Army Medical University, Chongqing, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Clinical Psychology, Mental Health Center of Chongqing, Chongqing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Psychology, Mental Health Center of Chongqing, Chongqing, China.'}]",JMIR research protocols,['10.2196/18259']
1258,32524424,High efavirenz levels but not neurofilament light plasma levels are associated with poor neurocognitive functioning in asymptomatic HIV patients.,"The aim of this study is to assess the effect of efavirenz exposure on neurocognitive functioning and investigate plasma neurofilament light (Nfl) as a biomarker for neurocognitive damage. Sub-analysis of the ESCAPE-study, a randomised controlled trial where virologically suppressed, cognitively asymptomatic HIV patients were randomised (2:1) to switch to rilpivirine or continue on efavirenz. At baseline and week 12, patients underwent an extensive neuropsychological assessment (NPA), and serum efavirenz concentration and plasma Nfl levels were measured. Subgroups of elevated (≥ 4.0 mg/L) and therapeutic (0.74 to< 4.0 mg/L) baseline efavirenz concentration were made. Differences between these groups in baseline NPA Z-scores and in delta scores after efavirenz discontinuation were assessed. Nfl level was measured using an ELISA analysis using single molecule array (Simoa) technology. Correlation of plasma NFL with NPA Z-scores was evaluated using a linear mixed model. The elevated group consisted of 6 patients and the therapeutic group of 48. At baseline, the elevated group showed lower composite Z-scores (median - 1.03; IQR 0.87 versus 0.27; 0.79. p 0.02). This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01). In the switch group, the elevated group improved more on composite scores after discontinuing efavirenz (mean 0.58; SD 0.32 versus 0.22; 0.54, p 0.15). No association between plasma Nfl and composite Z-score was found. High efavirenz exposure is associated with worse cognitive functioning compared with patients with therapeutic concentrations. Plasma Nfl is not a suitable biomarker to measure cognitive damage in this group.",2020,"This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01).","['cognitively asymptomatic HIV patients', 'asymptomatic HIV patients']","['efavirenz', 'rilpivirine or continue on efavirenz']","['plasma Nfl and composite Z-score', 'subdomains verbal', 'executive functioning', 'composite scores', 'cognitive functioning', 'extensive neuropsychological assessment (NPA), and serum efavirenz concentration and plasma Nfl levels', 'lower composite Z-scores', 'plasma NFL with NPA Z-scores']","[{'cui': 'C0343751', 'cui_str': 'Asymptomatic human immunodeficiency virus infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",6.0,0.0736464,"This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01).","[{'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Hakkers', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands. c.s.hakkers@umcutrecht.nl.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Hermans', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'van Maarseveen', 'Affiliation': 'Division of Laboratory and Pharmacy, Clinical Pharmacy, University Medical Center (UMC) Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Teunissen', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam Neuroscience Neurochemistry laboratory, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Inge M W', 'Initials': 'IMW', 'LastName': 'Verberk', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam Neuroscience Neurochemistry laboratory, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Joop E', 'Initials': 'JE', 'LastName': 'Arends', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'Andy I M', 'Initials': 'AIM', 'LastName': 'Hoepelman', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}]",Journal of neurovirology,['10.1007/s13365-020-00860-1']
1259,32524511,A novel approach to medicines optimisation post-discharge from hospital: pharmacist-led medicines optimisation clinic.,"Background There is a major drive within healthcare to reduce patient readmissions, from patient care and cost perspectives. Pharmacist-led innovations have been demonstrated to enhance patient outcomes. Objective To assess the impact of a post-discharge, pharmacist-led medicines optimisation clinic on readmission parameters. Assessment of the economic, clinical and humanistic outcomes were considered. Setting Respiratory and cardiology wards in a district general hospital in Northern Ireland. Method Randomised, controlled trial. Blinded random sequence generation; a closed envelope-based system, with block randomisation. Adult patients with acute unplanned admission to medical wards subject to inclusion criteria were invited to attend clinic. Analysis was carried out for intention-to-treat and per-protocol perspectives. Main Outcome Measure 30-day readmission rate. Results Readmission rate reduction at 30 days was 9.6% (P = 0.42) and the reduction in multiple readmissions over 180-days was 29.1% (P = 0.003) for the intention-to-treat group (n = 31) compared to the control group (n = 31). Incidence rate ratio for control patients for emergency department visits was 1.65 (95% CI 1.05-2.57, P = 0.029) compared with the intention-to-treat group. For unplanned GP consultations the equivalent incident rate ratio was 2.00 (95% CI 1.18-3.58, P = 0.02). Benefit to cost ratio in the intention-to-treat and per-protocol groups was 20.72 and 21.85 respectively. Patient Health Related Quality of Life was significantly higher at 30-day (P < 0.001), 90-day (P < 0.001) and 180-day (P = 0.036) time points. A positive impact was also demonstrated in relation to patient beliefs about their medicines and medication adherence. Conclusion A pharmacist-led post-discharge medicines optimisation clinic was beneficial from a patient care and cost perspective.",2020,"Patient Health Related Quality of Life was significantly higher at 30-day (P < 0.001), 90-day (P < 0.001) and 180-day (P = 0.036) time points.","['Adult patients with acute unplanned admission to medical wards subject to inclusion criteria were invited to attend clinic', 'Setting Respiratory and cardiology wards in a district general hospital in Northern Ireland']",[],"['Readmission rate reduction', 'Patient Health Related Quality of Life', 'multiple readmissions', 'Incidence rate ratio', '30-day readmission rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0730261', 'cui_str': 'Attending clinic'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}]",[],"[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}]",,0.208605,"Patient Health Related Quality of Life was significantly higher at 30-day (P < 0.001), 90-day (P < 0.001) and 180-day (P = 0.036) time points.","[{'ForeName': 'Mohanad', 'Initials': 'M', 'LastName': 'Odeh', 'Affiliation': 'Pharmacy Management and Pharmaceutical Care Innovation Centre, Hashemite University, 13133 Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Scullin', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hogg', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Fleming', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Scott', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'McElnay', 'Affiliation': ""Clinical and Practice Research Group, School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 7BL, UK. j.mcelnay@qub.ac.uk.""}]",International journal of clinical pharmacy,['10.1007/s11096-020-01059-4']
1260,32529588,Combination effects of diode laser and resin-modified tricalcium silicate on direct pulp capping treatment of caries exposures in permanent teeth: a randomized clinical trial.,"OBJECTIVE


The purpose of this randomized clinical trial was to evaluate efficiency of diode 808-nm (Picasso-AMD, USA) laser using power 1.5 W, continuous wave (CW), fiber diameter of 400 μm, non-initiated and in contact mode, tip angle set at 90°, beam divergence 16°, 2 s per an area with 1-mm diameter, power density 190.98 W/cm 2 , energy density 381.97 J/cm 2 , vertical and horizontal scanning movement on the exposure site, and laser irradiation combined with a resin-based tricalcium silicate material (TheraCal LC, Bisco, USA) in direct pulp capping in caries exposures of permanent teeth over a period of 6 months.
MATERIAL AND METHODS


In this randomized clinical trial, a total of 20 anterior and posterior vital teeth without symptoms and radiographic changes of 14 patients between the age group of 15-35 years, of which randomly 10 teeth were considered, each for TheraCal LC, the exposed area was sealed with TheraCal paste and TheraCal combined with diode laser; the treated area was sealed with TheraCal paste after diode 808-nm laser irradiation. At the 1-, 3-, and 6-month recall examinations, the loss of vitality, spontaneous pain, reactions to thermal stimuli and percussion, and radiographic changes were considered failure. The samples were randomly divided using runs test. Measurements on the digitized radiograph were performed at the recalls. The data were analyzed by repeated measurements ANOVA using SPSS 25.
RESULTS


Analysis had indicated that at the end of follow-ups, a statistically significant increase in dentin thickness with both groups (p value < 0.001) was found. Clinically, diode laser group has shown better results (p value < 0.001); however, radiographically, no significant difference was observed between groups (p value = 0.56). In both groups, the highest thickness of dentin formed was at the first month; 0.40 mm ± 0.19 mm (p value < 0.001).
CONCLUSION


Diode laser 808 nm under proper parameters combined with TheraCal LC can be recommended for direct pulp therapy in caries exposure of permanent teeth.
CLINICAL TRIAL REGISTRATION


This research was approved by Esfahan Medical University, Dental School, Azad Branch (KHUISF)) Esfahan, Iran [IR.IAU.KHUISF.REC.1397.261].",2020,"Clinically, diode laser group has shown better results (p value < 0.001); however, radiographically, no significant difference was observed between groups (p value = 0.56).","['Esfahan Medical University, Dental School, Azad Branch (KHUISF', 'caries exposures in permanent teeth', '20 anterior and posterior vital teeth without symptoms and radiographic changes of 14 patients between the age group of 15-35 years, of which randomly 10 teeth were considered, each for TheraCal LC, the exposed area was sealed with']","['diode laser and resin-modified tricalcium silicate', 'TheraCal paste and TheraCal combined with diode laser; the treated area was sealed with TheraCal paste after diode 808-nm laser irradiation', 'diode 808-nm (Picasso-AMD, USA) laser using power 1.5 W, continuous wave (CW), fiber diameter of 400 μm, non-initiated and in contact mode, tip angle set at 90°, beam divergence 16°, 2 s per an area with 1-mm diameter, power density 190.98 W/cm 2 , energy density 381.97 J/cm 2 , vertical and horizontal scanning movement on the exposure site, and laser irradiation combined with a resin-based tricalcium silicate material (TheraCal LC, Bisco, USA', 'diode laser', 'Diode laser 808 nm under proper parameters combined with TheraCal LC']","['dentin thickness', 'loss of vitality, spontaneous pain, reactions to thermal stimuli and percussion, and radiographic changes', 'highest thickness of dentin']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4547168', 'cui_str': 'TheraCal'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036492', 'cui_str': 'Seal'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1668343', 'cui_str': 'tricalcium silicate'}, {'cui': 'C4547168', 'cui_str': 'TheraCal'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0443204', 'cui_str': 'Divergence'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0229986', 'cui_str': 'Application site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C1100963', 'cui_str': 'bis(terpyridine)cobalt(II) chloride'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1997216', 'cui_str': 'Spontaneous pain'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0030987', 'cui_str': 'Percussion'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}]",10.0,0.0676895,"Clinically, diode laser group has shown better results (p value < 0.001); however, radiographically, no significant difference was observed between groups (p value = 0.56).","[{'ForeName': 'Iraj', 'Initials': 'I', 'LastName': 'Yazdanfar', 'Affiliation': 'Laser in Dentistry, RWTH University, Aachen, Germany.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Barekatain', 'Affiliation': 'Department of Restorative and Conservative Dentistry, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran. mehrbarekat@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zare Jahromi', 'Affiliation': 'Department of Endodontic, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran.'}]",Lasers in medical science,['10.1007/s10103-020-03052-9']
1261,32526534,The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities.,"Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design.
METHODS


RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months.
DISCUSSION


This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities.
TRIAL REGISTRATION


Clinicaltrials.govNCT02674464.",2020,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,['1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania'],"['RICH LIFE Project', 'enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC', 'SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates', 'health system only vs health system plus a collaborative/stepped care intervention']","['blood pressure (BP) control and patient activation', 'hypertension disparities', 'BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0348668', 'cui_str': 'Other and unspecified disorders of circulatory system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1890.0,0.09569,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: lisa.cooper@jhmi.edu.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marsteller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Dietz', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Romsai T', 'Initials': 'RT', 'LastName': 'Boonyasai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Chidinma A', 'Initials': 'CA', 'LastName': 'Ibe', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Deidra C', 'Initials': 'DC', 'LastName': 'Crews', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison-Himmelfarb', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lubomski', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tanjala S', 'Initials': 'TS', 'LastName': 'Purnell', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.001']
1262,32539907,Implementing shared decision-making on acute psychiatric wards: a cluster-randomized trial with inpatients suffering from schizophrenia (SDM-PLUS).,"AIMS


Although shared decision-making (SDM) has the potential to improve health outcomes, psychiatrists often exclude patients with more severe mental illnesses or more acute conditions from participation in treatment decisions. This study examines whether SDM is facilitated by an approach which is specifically adapted to the needs of acutely ill patients (SDM-PLUS).
METHODS


The study is a multi-centre, cluster-randomised, non-blinded, controlled trial of SDM-PLUS in 12 acute psychiatric wards of five psychiatric hospitals addressing inpatients with schizophrenia or schizoaffective disorder. All patients fulfilling the inclusion criteria were consecutively recruited for the trial at the time of their admission to the ward. Treatment teams of intervention wards were trained in the SDM-PLUS approach through participation in two half-day workshops. Patients on intervention wards received group training in SDM. Staff (and patients) of the control wards acted under 'treatment as usual' conditions. The primary outcome parameter was the patients' perceived involvement in decision-making at 3 weeks after study enrolment, analysed using a random-effects linear regression model.
RESULTS


In total, 161 participants each were recruited in the intervention and control group. SDM-PLUS led to higher perceived involvement in decision-making (primary outcome, analysed patients n = 257, mean group difference 16.5, 95% CI 9.0-24.0, p = 0.002, adjusted for baseline differences: β 17.3, 95% CI 10.8-23.6, p = 0.0004). In addition, intervention group patients exhibited better therapeutic alliance, treatment satisfaction and self-rated medication compliance during inpatient stay. There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up.
CONCLUSIONS


Despite limitations in patient recruitment, the SDM-PLUS trial has shown that the adoption of behavioural approaches (e.g. motivational interviewing) for SDM may yield a successful application to mental health. The authors recommend strategies to ensure effects are not lost at the interface between in- and outpatient treatment.Trial registration: The trial was registered at Deutsches Register Klinischer Studien (DRKS00010880).",2020,"There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up.
","['inpatients suffering from schizophrenia (SDM-PLUS', '12 acute psychiatric wards of five psychiatric hospitals addressing inpatients with schizophrenia or schizoaffective disorder', '161 participants each were recruited in the intervention and control group', 'acutely ill patients (SDM-PLUS', 'All patients fulfilling the inclusion criteria were consecutively recruited for the trial at the time of their admission to the ward']","['SDM', 'group training in SDM', 'SDM-PLUS']","['adherence and rehospitalisation rates', 'therapeutic alliance, treatment satisfaction and self-rated medication compliance', ""patients' perceived involvement in decision-making""]","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020021', 'cui_str': 'Psychiatric hospital'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",161.0,0.200858,"There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hamann', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Holzhüter', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Blakaj', 'Affiliation': 'Isar-Amper-Klinikum München Ost, Haar, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Becher', 'Affiliation': 'Klinik und Poliklinik für Psychiatrie und Psychotherapie, Technische Universität München, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Haller', 'Affiliation': 'Institut für Medizinische Informatik, Statistik und Epidemiologie, Technische Universität München, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Landgrebe', 'Affiliation': 'Lech Mangfall Klinikum, Agatharied, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmauß', 'Affiliation': 'Bezirkskrankenhaus Augsburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Heres', 'Affiliation': 'Isar-Amper-Klinikum München Ost, Haar, Germany.'}]",Epidemiology and psychiatric sciences,['10.1017/S2045796020000505']
1263,32536496,External Cardiac Massage Training of Medical Students: A Randomized Comparison of Two Feedback Methods to Standard Training.,"BACKGROUND


The most recent recommendations support learning of external cardiac massage (ECM) through feedback devices.
OBJECTIVES


The objective was to compare the effects on immediate and 3-month retention of ECM technical skills when using feedback devices compared with training without feedback as part of a half-day training session in medical students.
METHODS


This randomized study was performed using the Resusci Anne QCPR manikin in 64 medical students. We compared the quality of ECM with nonfeedback training in the control group (group 1) vs. 2 feedback learning methods (group 2, PocketCPR and group 3, Skill Reporter each used with visual display available to the trainee). At the end of the training session and 3 months later, students performed chest compressions blindly during a 2-min assessment session. The median compression score was the primary outcome for assessing immediate and long-term retention.
RESULTS


Regarding immediate retention, the median compression score was significantly lower in group 1 (23%) than in groups 2 (81%) and 3 (72%) (p < 0.05) with no difference between the 2 feedback methods. At 3 months, mean compression scores remained high but not significantly different between the 2 feedback groups.
CONCLUSION


The use of a feedback device used for ECM training improves the quality of immediate retention of technical ECM skills compared with traditional teaching in medical students. At 3 months, the 2 groups with feedback retained a high level of performance. No significant difference could be demonstrated between the 2 feedback methods.",2020,The use of a feedback device used for ECM training improves the quality of immediate retention of technical ECM skills compared with traditional teaching in medical students.,"['Medical Students', 'medical students', '64 medical students']","['external cardiac massage (ECM', 'External Cardiac Massage Training', 'ECM with nonfeedback training', 'feedback learning methods (group 2, PocketCPR and group 3, Skill Reporter each used with visual display available to the trainee', 'ECM training']","['mean compression scores', 'median compression score', 'quality of immediate retention of technical ECM skills']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0009039', 'cui_str': 'Manual external cardiac massage with closed chest'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0335038', 'cui_str': 'Reporter'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0009039', 'cui_str': 'Manual external cardiac massage with closed chest'}]",,0.0523229,The use of a feedback device used for ECM training improves the quality of immediate retention of technical ECM skills compared with traditional teaching in medical students.,"[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Suet', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Blanie', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'de Montblanc', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Roulleau', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Benhamou', 'Affiliation': 'Department of Anesthesia and Intensive Care Medicine, Hôpital Bicêtre, Le Kremlin Bicêtre, France; Paris Sud Medical School, Paris Sud University, Le Kremlin Bicêtre, France.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.04.058']
1264,32546645,Neutrophil-to-Lymphocyte Ratio as a Prognostic Factor of Disease-free Survival in Postnephrectomy High-risk Locoregional Renal Cell Carcinoma: Analysis of the S-TRAC Trial.,"PURPOSE


In the S-TRAC trial, adjuvant sunitinib improved disease-free survival (DFS) compared with placebo in patients with locoregional renal cell carcinoma (RCC) at high risk of recurrence. This  post hoc  exploratory analysis investigated the neutrophil-to-lymphocyte ratio (NLR) for predictive and prognostic significance in the RCC adjuvant setting.
EXPERIMENTAL DESIGN


Kaplan-Meier estimates and Cox proportional analyses were performed on baseline NLR and change from baseline at week 4 to assess their association with DFS. Univariate  P  values were two-sided and based on an unstratified log-rank test.
RESULTS


609 of 615 patients had baseline NLR values; 574 patients had baseline and week 4 values. Sunitinib-treated patients with baseline NLR <3 had longer DFS versus placebo (7.1 vs. 4.7; HR, 0.71;  P  = 0.02). For baseline NLR ≥3, DFS was similar regardless of treatment (sunitinib 6.8 vs. placebo not reached; HR, 1.03;  P  = 0.91). A ≥25% NLR decrease at week 4 was associated with longer DFS versus no change (6.8 vs. 5.3 years; HR, 0.71;  P  = 0.01). A greater proportion of sunitinib-treated patients had ≥25% NLR decrease at week 4 (71.2%) versus placebo (17.4%). Patients with ≥25% NLR decrease at week 4 received a higher median cumulative sunitinib dose (10,137.5 mg) versus no change (8,168.8 mg) or ≥25% increase (6,712.5 mg).
CONCLUSIONS


In the postnephrectomy high-risk RCC patient cohort, low baseline NLR may help identify those most suitable for adjuvant sunitinib. A ≥25% NLR decrease at week 4 may be an early indicator of those most likely to tolerate treatment and derive DFS benefit.",2020,"For baseline NLR ≥3, DFS was similar regardless of treatment (sunitinib 6.8 vs. placebo not reached; HR, 1.03; P = 0.91).",['patients with loco-regional renal cell carcinoma (RCC) at high risk of recurrence'],['placebo'],"['neutrophil-to-lymphocyte ratio (NLR', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.276738,"For baseline NLR ≥3, DFS was similar regardless of treatment (sunitinib 6.8 vs. placebo not reached; HR, 1.03; P = 0.91).","[{'ForeName': 'Anup', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'London, United Kingdom. anuppatel666@gmail.com.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Allan J', 'Initials': 'AJ', 'LastName': 'Pantuck', 'Affiliation': 'Ronald Reagan UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Staehler', 'Affiliation': 'University Hospital of Munich, Munich, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Martini', 'Affiliation': 'Pfizer Inc, La Jolla, California.'}, {'ForeName': 'Mariajose', 'Initials': 'M', 'LastName': 'Lechuga', 'Affiliation': 'Pfizer S.r.L, Milan, Italy.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Pfizer Inc, La Jolla, California.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': 'Duke Cancer Institute, Durham, North Carolina.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0704']
1265,32553497,Voiced High-Frequency Oscillation or Lax Vox Technique? Immediate Effects in Dysphonic Individuals.,"OBJECTIVES


To analyze the immediate effects of voiced high-frequency oscillation (VHFO) and Lax Vox technique on vocal quality and self-reported intensity of vocal and laryngeal symptoms in individuals with behavioral dysphonia.
METHODS


This experimental, prospective, randomized cross-over study, investigated thirty adults (15 women and 15 men) with behavioral dysphonia (vocal complaints, altered voice on auditory-perceptual evaluation, vocal nodules or mucosal thickening, and incomplete glottic closure). The outcome variables analyzed were auditory-perceptual analysis, acoustic analysis (voice quality characteristics), and self-reported intensities of vocal and laryngeal symptoms. Each participant performed two exercises-VHFO and Lax Vox technique-in a random sequence for 3 minutes. A 7-day washout period was provided between the exercises. The data were analyzed using the paired t-test and Wilcoxon test (P < 0.05).
RESULTS


After VHFO, no significant difference was observed on auditory-perceptual evaluation in all participants, whereas the Lax Vox technique worsened breathiness among women (P = 0.027). VHFO significantly increased the fundamental frequency (P = 0.014) and decreased the noise harmonic ratios for women (P = 0.026). Among men, there was a decrease in shimmer parameter (P = 0.035). Moreover, symptoms such as ""lump in the throat"" (P = 0.005), ""voice loss"" (P = 0.017), and ""high-pitched voice"" (P = 0.023) decreased in women after VHFO, whereas in men, ""itchiness"" and ""hoarseness"" (P < 0.001) decreased after VHFO. The Lax Vox technique decreased ""hoarseness"" (P = 0.003) in women, without any effect in men.
CONCLUSION


The VHFO exercise provided more positive immediate effects results than the Lax Vox technique regarding vocal quality and self-reported symptom intensity in participants with behavioral dysphonia.",2020,The VHFO exercise provided more positive immediate effects results than the Lax Vox technique regarding vocal quality and self-reported symptom intensity in participants with behavioral dysphonia.,"['participants with behavioral dysphonia', 'individuals with behavioral dysphonia', 'Dysphonic Individuals', 'thirty adults (15 women and 15 men) with behavioral dysphonia (vocal complaints, altered voice on auditory-perceptual evaluation, vocal nodules or mucosal thickening, and incomplete glottic closure']","['VHFO exercise', 'voiced high-frequency oscillation (VHFO) and Lax Vox technique']","['vocal quality and self-reported symptom intensity', 'voice loss', 'hoarseness', 'noise harmonic ratios', 'auditory-perceptual evaluation', 'auditory-perceptual analysis, acoustic analysis (voice quality characteristics), and self-reported intensities of vocal and laryngeal symptoms', 'high-pitched voice', 'vocal quality and self-reported intensity of vocal and laryngeal symptoms', 'fundamental frequency']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C3686502', 'cui_str': 'Mucosal thickening'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C2718088', 'cui_str': 'High Frequency Oscillation Ventilation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0003564', 'cui_str': 'Aphonia'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0241703', 'cui_str': 'High pitched voice'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",30.0,0.028443,The VHFO exercise provided more positive immediate effects results than the Lax Vox technique regarding vocal quality and self-reported symptom intensity in participants with behavioral dysphonia.,"[{'ForeName': 'Rebeca Liaschi', 'Initials': 'RL', 'LastName': 'Floro Silva', 'Affiliation': 'Department of Speech Hearing and Language Disorders, Faculdade de Odontologia de Bauru, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Angélica Emygdio', 'Initials': 'AE', 'LastName': 'da Silva Antonetti', 'Affiliation': 'Department of Speech Hearing and Language Disorders, Faculdade de Odontologia de Bauru, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vanessa Veis', 'Initials': 'VV', 'LastName': 'Ribeiro', 'Affiliation': 'Speech-Language Pathology Audiology Department, Universidade Federal de Sergipe, Lagarto, Sergipe, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Ramos', 'Affiliation': 'Department of Speech Hearing and Language Disorders, Faculdade de Odontologia de Bauru, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alcione Ghedini', 'Initials': 'AG', 'LastName': 'Brasolotto', 'Affiliation': 'Department of Speech Hearing and Language Disorders, Faculdade de Odontologia de Bauru, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Kelly Cristina Alves', 'Initials': 'KCA', 'LastName': 'Silverio', 'Affiliation': 'Department of Speech Hearing and Language Disorders, Faculdade de Odontologia de Bauru, Universidade de São Paulo, São Paulo, Brazil. Electronic address: kellysilverio@usp.br.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.05.004']
1266,32524612,Impact of Labeled Glasses in a Bar Laboratory Setting: No Effect on Ad Libitum Alcohol Consumption.,"AIMS


Information provided on glass labels may be an effective method to reduce alcohol consumption. The aim of this study was to assess the impact of glass labels conveying unit information and a health warning in reducing ad libitum alcohol consumption.
METHODS


A cluster-randomized experimental study was conducted to measure the efficacy of a labeled glass in reducing alcohol consumption in a semi naturalistic bar laboratory setting, in a sample of 81 pairs (n = 162) of UK young adult drinkers. Pairs were randomized to receive two 340-ml glasses of beer or wine: labeled or plain (control). Alcohol consumption was assessed in an ad libitum drinking period, and urge to drink was measured at baseline and postdrinking period. Focus groups (n = 2) were conducted, and thematic analysis was used to gain an insight into the acceptability and the perceived effectiveness of the glasses.
RESULTS


Mean unit consumption was 1.62 (SD ± 0.83) units in the labeled glass condition and 1.69 (SD ± 0.82) units in the non labeled glass condition. There were no significant effects of the labeled glasses on ad libitum alcohol consumption (95% CI -0.25 to 0.37, p = 0.35), despite participants (85%) noticing the information. Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behavior due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts.
CONCLUSIONS


Labeled glasses did not change alcohol consumption in the current study, potentially due to ineffectiveness of this type of message in a young adult population. The information on the glasses was attended to, highlighting that glasses could be a feasible tool for providing information.",2020,"Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behaviour due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts.
","['a semi-naturalistic bar-laboratory setting, in a sample of 81 pairs (n = 162) of UK young adult drinkers']","['labelled glass', '340 ml glasses of beer or wine: labelled or plain (control', 'labelled glasses']","['alcohol consumption', 'Mean unit consumption', 'labelled glasses on ad libitum alcohol consumption', 'Alcohol consumption']","[{'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]",2.0,0.0811205,"Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behaviour due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts.
","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'University of Cambridge Institute of Public Health, (NC), Cambridge, UK.'}, {'ForeName': 'Abigail K', 'Initials': 'AK', 'LastName': 'Rose', 'Affiliation': 'Department of Psychological Sciences, (NC, AKR), University of Liverpool, Liverpool, UK.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14392']
1267,32534361,Long-term effects of mindfulness-based cognitive therapy in patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy: Twelve-month follow-up of a randomized controlled trial.,"We examined the long-term efficacy of mindfulness-based cognitive therapy (MBCT) compared to a psychoeducation group as an active control condition in patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy. A total of 125 patients were included in a bicentric, interviewer-blind, randomized, and actively controlled trial and were assigned to either an MBCT group (n = 61) or a psychoeducation group (n = 64). Patients' demographic characteristics and the results from our previous assessments have already been reported (Külz et al., 2019). At the 12-month follow-up the completion rate was 80%. OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups. Exploratory analyses showed that a composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts differed between groups in the per-protocol analysis, with a stronger reduction in the MBCT group. At the 12-month follow-up, the two groups showed a similar reduction of symptoms. However, preliminary evidence indicates that MBCT has a superior effect on some aspects of OCD. This should be replicated in future studies.",2020,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","['patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy', 'patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy', 'A total of 125 patients']","['MBCT', 'mindfulness-based cognitive therapy', 'mindfulness-based cognitive therapy (MBCT']","['OCD symptoms', 'composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679048', 'cui_str': 'Obsessive thoughts'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",125.0,0.0493293,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cludius', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany. Electronic address: barbara.cludius@psy.lmu.de.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Landmann', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rose', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenreich', 'Affiliation': 'Esslingen University of Applied Sciences; Flandernstraße 101, 73732 Esslingen am Neckar, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Hottenrott', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany; Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Voderholzer', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany;; Schoen Clinic Roseneck, Am Roseneck 6, 83209 Prien am Chiemsee, Germany; Clinic for Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'Anne Katrin', 'Initials': 'AK', 'LastName': 'Külz', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}]",Psychiatry research,['10.1016/j.psychres.2020.113119']
1268,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE


Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D.
SUBJECTS/METHODS


Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction.
RESULTS


After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
CONCLUSIONS


Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571']
1269,32540553,Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM).,"BACKGROUND


The combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC.
Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied.
RESULTS


Sixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1-98). ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3-4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt.
CONCLUSIONS


Combination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment.",2020,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","['Patients at first relapse or with synchronous metastasis', 'HER-2 positive advanced breast cancer', 'HER-2 positive advanced breast cancer (ABC) therapy', 'Sixty patients with measurable ABC, tumors scored as\xa0+3 for HER-2 or FISH\xa0+, untreated for advanced disease were enrolled', 'Fifteen patients had SD (25']","['trastuzumab', 'cyclophosphamide', 'chemotherapy plus anti HER-2 agents', 'trastuzumab and metronomic capecitabine/cyclophosphamide (HEX', 'trastuzumab and metronomic oral chemotherapy', 'oral capecitabine', 'Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX']","['Median PFS', 'grade 2 nausea', 'Median OS', 'Worst toxicities', 'grade 3 anaemia', 'ORR', 'objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR\xa0+\xa0CR\xa0+\xa0SD for\xa0≥\xa024 weeks) and tolerability', 'Cardiac toxicity grade 1', 'tolerability', 'Median number of cycles', 'visceral metastases', 'grade 3-4 diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",9.0,0.0480206,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy. Electronic address: laura.orlando68@gmail.com.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin at Ordine Mauriziano Hospital, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Schiavone', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Palma', 'Initials': 'P', 'LastName': 'Fedele', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Quaranta', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caliolo', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': 'Medical Oncology, Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Cinefra', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Sante', 'Initials': 'S', 'LastName': 'Romito', 'Affiliation': 'Medical Oncology, Ospedali Riuniti, Foggia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Medical Oncology, Ospedale Moscato, Taranto, Italy.'}, {'ForeName': 'Salvatore Del', 'Initials': 'SD', 'LastName': 'Prete', 'Affiliation': 'Medical Oncology, Ospedale San Giovanni di Dio, Frattamaggiore, Napoli, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Medical Oncology, Ospedale Oncologico Regionale, Rionero in Vulture, Potenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rizzi', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology, Ospedale Sollievo Della Sofferenza, IRCCS, San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.002']
1270,32535263,Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial.,"BACKGROUND


Postoperative cognitive dysfunction (POCD) is a complication of central nervous system in patients after surgery. Edaravone as a brain-protective agent may have protective effect on postoperative cognitive function. The study was designed to explore the effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery and potential mechanism.
PATIENTS AND METHODS


Patients undergoing hip joint replacement surgery were randomly allocated into 2 groups: the edaravone group (group E) and the control group (group C). Group E received intravenous edaravone at a dose of 0.5 mg/kg after induction of anesthesia, while group C received normal saline. The cognitive function was evaluated with the Mini-Mental State Examination (MMSE) 1day before surgery,3 days and the 7 days after surgery. Patients' plasma samples were collected to detect the levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA) before the induction of anesthesia, at the end of surgery and on postoperative day 3.
RESULTS


The MMSE scores in group E were higher than those of group C 3 days after surgery (25.98 ± 1.99 vs 24.86 ± 1.86, p = 0.003). There were remarkable rises (p < 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p < 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03 ± 2.46U/ml vs. 13.65 ± 2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01 ± 2.37 nmol/ml vs. 11.34 ± 3.18 nmol/ml, p = 0.0001).
CONCLUSION


The results indicated that preoperative intervention with edaravone may improve the postoperative cognitive function in elderly patients undergoing hip joint replacement surgery.",2020,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001).
","['eldely patients undergoing hip joint replacement surgery and potential mechanism', 'Patients undergoing hip joint replacement surgery', 'patients after surgery', 'elderly patients undergoing hip joint replacement surgery']","['intravenous edaravone', 'normal saline', 'edaravone', 'Edaravone']","['MDA level', 'MMSE scores', 'cognitive function', 'SOD concentration', 'levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA', 'postoperative cognitive function', 'plasma IL-6, S100βand MMP-9 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.097904,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001).
","[{'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China. Electronic address: sun_long2@163.com.'}, {'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China.'}, {'ForeName': 'Yang-Liang', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China. Electronic address: nange1984@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.092']
1271,32556960,Corticosteroids to prevent kidney scarring in children with a febrile urinary tract infection: a randomized trial.,"BACKGROUND


To evaluate the efficacy of adjuvant systemic corticosteroids in reducing kidney scarring. A previous study suggested that use of adjuvant systemic corticosteroids reduces kidney scarring in children radiologically confirmed to have extensive pyelonephritis. Efficacy of corticosteroids for children with febrile urinary tract infection (UTI) has not been studied.
METHODS


Children aged 2 months to 6 years with their first febrile UTI were randomized to corticosteroids or placebo for 3 days (both arms received antimicrobial therapy); kidney scarring was assessed using  99m Tc-dimercaptosuccinic acid kidney scan 5-24 months after the initial UTI.
RESULTS


We randomized 546 children of which 385 had a UTI and 254 had outcome kidney scans (instead of the 320 planned). Rates of kidney scarring were 9.8% (12/123) and 16.8% (22/131) in the corticosteroid and placebo groups, respectively (p = 0.16), corresponding to an absolute risk reduction of 5.9% (95% confidence interval: - 2.2, 14.1).
CONCLUSION


While children randomized to adjuvant corticosteroids tended to develop fewer kidney scars than children who were randomized to receive placebo, a statistically significant difference was not achieved. However, the study was limited by not reaching its intended sample size.
CLINICAL TRIAL REGISTRATION


Clinicaltrials.gov , NCT01391793, Registered 7/12/2011 Graphical abstract.",2020,"Rates of kidney scarring were 9.8% (12/123) and 16.8% (22/131) in the corticosteroid and placebo groups, respectively (p = 0.16), corresponding to an absolute risk reduction of 5.9% (95% confidence interval: - 2.2, 14.1).
","['children with febrile urinary tract infection (UTI', 'Children aged 2\xa0months to 6\xa0years with their first febrile UTI', 'children with a febrile urinary tract infection', '546 children of which 385 had a UTI and 254 had outcome kidney scans (instead of the 320 planned']","['adjuvant systemic corticosteroids', 'corticosteroids or placebo', 'corticosteroids', 'Corticosteroids', 'antimicrobial therapy); kidney scarring was assessed using  99m', 'placebo']","['kidney scarring', 'kidney scars', 'Rates of kidney scarring']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3875265', 'cui_str': 'Febrile urinary tract infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0412412', 'cui_str': 'Kidney imaging with function study'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017658', 'cui_str': 'Glomerulonephritis'}]","[{'cui': 'C0017658', 'cui_str': 'Glomerulonephritis'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]",546.0,0.616011,"Rates of kidney scarring were 9.8% (12/123) and 16.8% (22/131) in the corticosteroid and placebo groups, respectively (p = 0.16), corresponding to an absolute risk reduction of 5.9% (95% confidence interval: - 2.2, 14.1).
","[{'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Shaikh', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. nader.shaikh@chp.edu.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Shope', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Hoberman', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Gysella B', 'Initials': 'GB', 'LastName': 'Muniz', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Sonika', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nowalk', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Hickey', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Marian G', 'Initials': 'MG', 'LastName': 'Michaels', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Kearney', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Howard E', 'Initials': 'HE', 'LastName': 'Rockette', 'Affiliation': 'Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Charron', 'Affiliation': 'Department of Radiology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Massoud', 'Initials': 'M', 'LastName': 'Majd', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Eglal', 'Initials': 'E', 'LastName': 'Shalaby-Rana', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Kurs-Lasky', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Cohen', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'Wald', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Lockhart', 'Affiliation': ""Hasbro Children's Hospital, Alpert Medical School, Providence, RI, USA.""}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'Pohl', 'Affiliation': ""Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04622-3']
1272,32557087,Thromboelastometry and a hemostasis management system are most beneficial for guiding hemostatic therapy in cardiac surgery patients with a EuroSCORE II of ≥1.83%: a randomized controlled two-step trial.,"PURPOSE


We evaluated the efficacy of hemostatic therapy based on point-of-care (POC) testing in patients undergoing cardiac surgery.
METHODS


This was a single-institution, prospective, randomized, double-blinded study. In step 1, 90 patients scheduled for elective cardiac surgery underwent complete blood count and fibrinogen measurements at baseline, after cardiopulmonary bypass (CPB) initiation (CPB start), just after CPB end, and in the intensive care unit (ICU). In step 2, 72 patients scheduled for elective cardiac surgery underwent conventional laboratory coagulation tests (control group) or POC coagulation tests (POC group). Transfusions were prepared using the fibrinogen and platelet values at mainly ""CPB start"" for the control group, and using the ROTEM values at mainly ""CPB end"" for the POC group. Consequently, the step 2 patients were divided into high- and low-risk subgroups based on the EuroSCORE II by logistic regression analysis; transfusion data and bleeding volumes were compared between the control and POC groups within the high- and low-risk subgroups.
RESULTS


In step 1, all blood components were significantly decreased at CPB start compared with baseline, and platelet and fibrinogen levels remained almost constant from CPB start to end. In step 2, the transfusion rates and perioperative bleeding volumes did not significantly differ between the control and POC groups. Subgroup analysis suggested that only the high-risk subgroup significantly differed regarding perioperative red blood cell transfusion and total bleeding volume in the ICU.
CONCLUSIONS


POC testing is beneficial for cardiac surgery patients with a EuroSCORE II of ≥1.83%.",2020,"In step 1, all blood components were significantly decreased at CPB start compared with baseline, and platelet and fibrinogen levels remained almost constant from CPB start to end.","['72 patients scheduled for elective cardiac surgery underwent', 'cardiac surgery patients with a EuroSCORE II of ≥1.83', '90 patients scheduled for elective cardiac surgery', 'patients undergoing cardiac surgery']","['Thromboelastometry and a hemostasis management system', 'hemostatic therapy', 'conventional laboratory coagulation tests (control group) or POC coagulation tests (POC group']","['transfusion rates and perioperative bleeding volumes', 'platelet and fibrinogen levels', 'perioperative red blood cell transfusion and total bleeding volume', 'blood components']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}]","[{'cui': 'C3661505', 'cui_str': 'Thromboelastometry'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1504378', 'cui_str': 'Coagulation test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085430', 'cui_str': 'Transfusion of blood component'}]",90.0,0.0886223,"In step 1, all blood components were significantly decreased at CPB start compared with baseline, and platelet and fibrinogen levels remained almost constant from CPB start to end.","[{'ForeName': 'Mitsuharu', 'Initials': 'M', 'LastName': 'Kodaka', 'Affiliation': ""Department of Anesthesiology and Intensive Care, Tokyo Women's Medical University Medical Center East, Arakawa-ku, Tokyo, 116-8567, Japan. kmkodaka@cb3.so-net.ne.jp.""}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Ichikawa', 'Affiliation': ""Department of Anesthesiology and Intensive Care, Tokyo Women's Medical University Medical Center East, Arakawa-ku, Tokyo, 116-8567, Japan.""}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': ""Department of Anesthesiology and Intensive Care, Tokyo Women's Medical University Medical Center East, Arakawa-ku, Tokyo, 116-8567, Japan.""}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Komori', 'Affiliation': ""Department of Anesthesiology and Intensive Care, Tokyo Women's Medical University Medical Center East, Arakawa-ku, Tokyo, 116-8567, Japan.""}]",Journal of anesthesia,['10.1007/s00540-020-02810-x']
1273,32554183,The interactive effects of test-retest and methylphenidate administration on cognitive performance in youth with ADHD: A double-blind placebo-controlled crossover study.,"Studies have shown that Methylphenidate (MPH) affects cognitive performance on the neuropsychological tests and clinical symptoms of individuals diagnosed with attention deficit/hyperactivity disorder (ADHD). This study investigated the acute effects of MPH on neuropsychological tests to explore the interaction between MPH and test-retest effects. Twenty youths with ADHD were tested before and after MPH intake in a double-blind placebo-controlled crossover design and compared to twenty matched controls. Participants were tested on a range of standardized tasks including sustained attention to response, N-Back, and Word/Color Stroop. Identical tasks were administered twice each testing day, before and 1 hour after MPH/Placebo administration. Healthy controls were tested similarly with no intervention. Decreases in response time (RT) variability across tasks and in commission errors were found in ADHD after MPH. Conversely, a significant increase in RT variability and increase in omission errors were observed after the placebo. In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively. Test-retest reliability was higher in controls than ADHD. It is suggested that cognitive tests are sensitive objective measures for the assessment of responses to MPH in ADHD but are also affected by repetition and fatigue.",2020,"In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively.","['youth with ADHD', 'individuals diagnosed with attention deficit/hyperactivity disorder (ADHD', 'Twenty youths with ADHD']","['Methylphenidate (MPH', 'methylphenidate', 'placebo']","['cognitive performance', 'RT variability and omission errors', 'Test-retest reliability', 'sustained attention to response, N-Back, and Word/Color Stroop', 'RT variability', 'response time (RT) variability across tasks and in commission errors', 'omission errors', 'commission errors']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",20.0,0.196672,"In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively.","[{'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Horowitz', 'Affiliation': ""Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: itaizen@gmail.com.""}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Avirame', 'Affiliation': ""Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Naim-Feil', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel; Sagol Center for Brain and Mind, Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC), Herzliya, Israel.'}, {'ForeName': 'Mica', 'Initials': 'M', 'LastName': 'Rubinson', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Moses', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Gothelf', 'Affiliation': ""Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Child and Adolescent Psychiatry Division, The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Levit-Binnun', 'Affiliation': 'Sagol Center for Brain and Mind, Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC), Herzliya, Israel.'}]",Psychiatry research,['10.1016/j.psychres.2020.113056']
1274,32555927,Short-term efficacy and safety of levosimendan in patients with chronic systolic heart failure.,"The objective was to investigate and evaluate the short-term efficacy and safety of levosimendan in patients with chronic systolic heart failure. Forty-nine patients with chronic systolic heart failure during acute decompensation were randomly divided into a levosimendan group (26 cases) and a control group (23 cases). The control group received only routine treatment, while the levosimendan group received a levosimendan bolus with a load of 12 µg/kg, in addition to the same routine treatment as the control group. After 48 hours of treatment, N-terminal pro B-type natriuretic peptide (NT-proBNP) levels in the levosimendan group were significantly lower than those in the control group. In addition, the left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) cardiac function scores of the levosimendan group were significantly higher and more improved than those of the control group seven days after treatment, but there was no significant difference in the left ventricular end-diastolic diameter between the two groups. Furthermore, 48 hours after treatment, there were no significant differences in potassium, haemoglobin, haematocrit and creatinine levels between the levosimendan and control groups. During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group. Levosimendan significantly improved NT-proBNP and LVEF in patients with chronic systolic heart failure, and improved NYHA cardiac function classification without significant cardiovascular events. Levosimendan is therefore effective and safe in the short-term treatment of chronic systolic heart failure.",2020,"During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group.","['Forty-nine patients with chronic systolic heart failure during acute decompensation', 'patients with chronic systolic heart failure']","['Levosimendan', 'levosimendan', 'levosimendan bolus']","['sudden death', 'hypotension or severe hypokalaemia', 'left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) cardiac function scores', 'potassium, haemoglobin, haematocrit and creatinine levels', 'NT-proBNP and LVEF', 'left ventricular end-diastolic diameter']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135194', 'cui_str': 'Chronic systolic heart failure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}]","[{'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",49.0,0.0197414,"During the whole hospitalisation, there was one case of sudden death in the control group and one case of palpitations in the levosimendan group, and no hypotension or severe hypokalaemia occurred in either group.","[{'ForeName': 'Xiao-Ran', 'Initials': 'XR', 'LastName': 'Cui', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Yang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Rui-Bin', 'Initials': 'RB', 'LastName': 'Li', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Jia', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Ji-Dong', 'Initials': 'JD', 'LastName': 'Zhang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. Email: zhangjidong78@163.com.'}]",Cardiovascular journal of Africa,['10.5830/CVJA-2020-008']
1275,32559669,A novel digital health intervention to improve patient engagement to stimulants in adult ADHD in the primary care setting: Preliminary findings from an open label study.,"AIMS


We piloted the effectiveness and acceptability of a novel text messaging-based (SMS) digital health intervention aimed at addressing the previously documented poor rate of patient engagement in stimulant treatment in the primary care setting.
METHODS


117 adults ages 18-55 from primary care and psychiatric practices who were prescribed a stimulant medication for ADHD treatment received the SMS intervention. Comparators were age-, race-, and sex-matched patients from the same health care organization's electronic medical record who had been prescribed stimulant medications over a similar time period. Using documented prescription records, we determined whether patients had timely prescription refills.
RESULTS


Ninety-six percent (N = 112) of participants completed our a priori metric of patient engagement consisting of 37 days of the SMS program. Eighty-one percent of participants refilled their index prescriptions in a timely manner compared to only 36% of patients receiving treatment as usual (OR=7.54, 95% CI: 4.46, 12.77; p<0.001). We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual).
CONCLUSIONS


These data suggest that an ADHD-centric, digital health intervention using text messaging significantly improves patient engagement in stimulant treatment in adults with ADHD.",2020,"We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual).
","[""Comparators were age-, race-, and sex-matched patients from the same health care organization's electronic medical record who had been prescribed stimulant medications over a similar time period"", 'adults with ADHD', 'adult ADHD in the primary care setting', '117 adults ages 18-55 from primary care and psychiatric practices who were prescribed a stimulant medication for ADHD treatment received the']","['SMS intervention', 'digital health intervention', 'novel text messaging-based (SMS) digital health intervention']",['patient engagement'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3508152', 'cui_str': 'Patient Engagement'}]",117.0,0.0801889,"We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual).
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA. Electronic address: jbiederman@partners.org.'}, {'ForeName': 'Ronna', 'Initials': 'R', 'LastName': 'Fried', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'DiSalvo', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Driscoll', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'K Yvonne', 'Initials': 'KY', 'LastName': 'Woodworth', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Faraone', 'Affiliation': 'Departments of Psychiatry and of Neuroscience and Physiology, SUNY Upstate Medical University, Syracuse, NY, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113158']
1276,32561260,Quantitative Analysis of Patellar Tendon After Total Knee Arthroplasty Using Echo Intensity: A Nonrandomized Controlled Trial of Alpine Skiing.,"BACKGROUND


Despite the knee extensor weakness, less attention has been paid to the evaluation of patellar tendon after total knee arthroplasty (TKA). We previously observed patellar tendon hypertrophy after TKA. The purpose of this study is to reanalyze these ultrasound data to detect whether brightness mode ultrasound imaging reflects pathological changes of the patellar tendon after TKA.
METHODS


Twenty-eight participants with post unilateral TKA were assigned to an intervention group or control group. The intervention group underwent a 12-week skiing program. Patellar tendon mechanical properties were obtained by combining isometric dynamometry, ultrasound imaging, and electromyography in operated knee and nonoperated knee. Luminosity ratio (LR) was measured using echo intensity in a relaxed and maximally loaded phase.
RESULTS


Baseline comparisons revealed significant effects of the surgical side (P < .001) and loading phase (P = .017), but no interaction between leg and phase (P < .149). LR of the operated knee was significantly lower than LR of the nonoperated knee in relaxed (P < .001) and maximally loaded phases (P = .003). In addition, there was a significant correlation between LR of maximum phase and isometric knee extension torque (r 2  = 0.156, P = .038). However, LR was not related to patellar tendon stiffness, Young's modulus, or strain. There was a significant time effect in knee extension torque, but no time effects on LR and tendon force.
CONCLUSION


Patellar tendon LR is decreased along with degenerative change after TKA. Ultrasound imaging provides a promising metric to acquire in vivo patellar tendon pathological assessment after TKA.",2020,LR of the operated knee was significantly lower than LR of the nonoperated knee in relaxed (P < .001) and maximally loaded phases (P = .003).,['Twenty-eight participants with post unilateral TKA'],"['intervention group or control group', '12-week skiing program']","['Luminosity ratio (LR', 'knee extension torque', 'loading phase', 'surgical side', 'LR and tendon force', 'Quantitative Analysis of Patellar Tendon', 'LR of maximum phase and isometric knee extension torque', 'Patellar tendon mechanical properties']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0037264', 'cui_str': 'Skiing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",28.0,0.050386,LR of the operated knee was significantly lower than LR of the nonoperated knee in relaxed (P < .001) and maximally loaded phases (P = .003).,"[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Sport and Exercise Science, Paris Lodron University of Salzburg, Salzburg, Austria; Department of Orthopedic Surgery, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kösters', 'Affiliation': 'Department of Sport and Exercise Science, Paris Lodron University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rieder', 'Affiliation': 'Department of Sport and Exercise Science, Paris Lodron University of Salzburg, Salzburg, Austria; Department of Physical Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Sasho', 'Affiliation': 'Department of Orthopedic Surgery, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Müller', 'Affiliation': 'Department of Sport and Exercise Science, Paris Lodron University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Wiesinger', 'Affiliation': 'Department of Sport and Exercise Science, Paris Lodron University of Salzburg, Salzburg, Austria.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.05.052']
1277,32561266,HTX-011 Reduced Pain and Opioid Use After Primary Total Knee Arthroplasty: Results of a Randomized Phase 2b Trial.,"BACKGROUND


HTX-011 is an extended-release, dual-acting local anesthetic consisting of bupivacaine and low-dose meloxicam in a novel polymer that is administered by needle-free application during surgery. The active ingredients are released from the polymer by controlled diffusion over 72 hours.
METHODS


This phase 2b, double-blind, placebo-controlled and active-controlled trial enrolled patients undergoing primary unilateral total knee arthroplasty under general anesthesia. Two hundred thirty-two patients were randomized into 4 groups: HTX-011 400 mg bupivacaine/12 mg meloxicam, applied without a needle into the surgical site, the same dose of HTX-011 with a separate 50 mg ropivacaine injection into the posterior capsule, bupivacaine hydrochloride (HCl) 125 mg injection, and saline placebo injection. Only opioids were permitted for postoperative pain rescue. Primary and key secondary endpoints were mean area under the curve of pain intensity scores over 48 hours and 72 hours, respectively, for HTX-011 groups vs placebo.
RESULTS


Both HTX-011 groups had significantly reduced mean pain intensity vs placebo through 48 and 72 hours (both P < .001). Ropivacaine added a small initial benefit in the first 12 hours. Both HTX-011 groups also had decreased mean pain intensity vs bupivacaine HCl alone through 48 and 72 hours (P < .05). The HTX-011 groups had significantly earlier discharge readiness along with lower opioid consumption through 72 hours. HTX-011 alone or with ropivacaine was well-tolerated with a safety profile similar to controls.
CONCLUSION


Needle-free application of HTX-011 400 mg bupivacaine/12 mg meloxicam provided superior pain reduction through 72 hours after total knee arthroplasty compared with placebo and bupivacaine HCl alone.",2020,Both HTX-011 groups had significantly reduced mean pain intensity vs placebo through 48 and 72 hours (both P < .001).,"['After Primary Total Knee Arthroplasty', 'patients undergoing primary unilateral total knee arthroplasty under general anesthesia', 'Two hundred thirty-two patients']","['bupivacaine HCl', 'bupivacaine', 'meloxicam', 'ropivacaine injection into the posterior capsule, bupivacaine hydrochloride (HCl) 125 mg injection, and saline placebo injection', 'ropivacaine', 'HTX-011 400 mg bupivacaine/12 mg meloxicam', 'Ropivacaine', 'placebo']","['mean pain intensity', 'earlier discharge readiness', 'postoperative pain rescue', 'Pain and Opioid Use', 'mean area under the curve of pain intensity scores', 'superior pain reduction']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C4080371', 'cui_str': 'ropivacaine Injection'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",232.0,0.326028,Both HTX-011 groups had significantly reduced mean pain intensity vs placebo through 48 and 72 hours (both P < .001).,"[{'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Lachiewicz', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University, Chapel Hill, NC.'}, {'ForeName': 'Gwo-Chin', 'Initials': 'GC', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania, Penn Medicine University City, Philadelphia, PA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Pollak', 'Affiliation': 'Endeavor Clinical Trials, San Antonio, TX.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Leiman', 'Affiliation': 'HD Research Corp, Houston, TX; Department of Surgery, University of Texas at Houston, Houston, TX.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Heron Therapeutics Inc, San Diego, CA.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Sah', 'Affiliation': 'Sah Orthopaedic Associates, Center for Joint Replacement Bldg, Fremont, CA.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.05.044']
1278,32533948,Corneal Topography Raw Data Classification Using a Convolutional Neural Network.,"PURPOSE


We investigated the efficiency of a convolutional neural network applied to corneal topography raw data to classify examinations of 3 categories: normal, keratoconus (KC), and history of refractive surgery (RS).
DESIGN


Retrospective machine-learning experimental study.
METHODS


A total of 3,000 Orbscan examinations (1,000 of each class) of different patients of our institution were selected for model training and validation. One hundred examinations of each class were randomly assigned to the test set. For each examination, the raw numerical data from ""elevation against the anterior best fit sphere (BFS),"" ""elevation against the posterior BFS"" ""axial anterior curvature,"" and ""pachymetry"" maps were used. Each map was a square matrix of 2,500 values. The 4 maps were stacked and used as if they were 4 channels of a single image.A convolutional neural network was built and trained on the training set. Classification accuracy and class wise sensitivity and specificity were calculated for the validation set.
RESULTS


Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%). Sensitivity and specificity were, respectively, 100% and 100% for KC, 100% and 99% (94.9%-100%) for normal examinations, and 98% (97.4%-100%) and 100% for RS examinations.
CONCLUSION


Using combined corneal topography raw data with a convolutional neural network is an effective way to classify examinations and probably the most thorough way to automatically analyze corneal topography. It should be considered for other routine tasks performed on corneal topography, such as refractive surgery screening.",2020,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"['3,000 Orbscan examinations (1000 of each class) of different patients of our institution were selected for model training and validation', '100 examinations of each class']",[],"['Classification accuracy and class wise sensitivity and specificity', 'Sensitivity and specificity']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1704407', 'cui_str': '100'}]",[],"[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",,0.0443956,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Zéboulon', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France. Electronic address: pierrezeboulon@gmail.com.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Debellemanière', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France.'}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Bouvet', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gatinel', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France; CEROC (Center of Expertise and Research in Optics for Clinicians), Paris, France.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.005']
1279,32540685,"Impact of the group intervention ""Accept Voices©"" for the management of auditory hallucinations.","AIM OF THE STUDY


The objective of this study was to evaluate the potential impact of a third wave CBT group intervention for the management of auditory hallucinations in patients with schizophrenia.
METHOD


38 patients with schizophrenia presenting with auditory hallucinations, followed in mental health services, participated in six sessions of a group based on acceptance and engagement therapy (ACT). The study followed a repeated single case experimental design (type A-B-A) based on the principle of a control phase followed by an intervention phase and a follow-up phase of similar duration. The various measurements were administered during the control phase, at pre-/post-group and six weeks after the last group session.
RESULTS


The results show a significant decrease in auditory hallucinations, as measured by the PSYRATS scale, during the treatment and follow-up phase, compared to the control phase. In addition, the participants saw significant reductions in depressive and anxious symptomatology (assessed with CDSS and SEAS), and increases in coping and acceptance in regards to voices (assessed using a study scale and VAAS). The level of Malevolence beliefs about voices (measured with BAVQ-R) also decreased significantly.
CONCLUSIONS


A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.",2020,"A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.","['patients with schizophrenia', '38 patients with schizophrenia presenting with auditory hallucinations, followed in mental health services, participated in six sessions of a group based on']","['acceptance and engagement therapy (ACT', 'CBT group intervention']","['depressive and anxious symptomatology', 'auditory hallucinations', 'level of Malevolence beliefs about voices (measured with BAVQ-R', 'coping and acceptance', 'intensity of auditory hallucinations, depression and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",38.0,0.0263279,"A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Langlois', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France. Electronic address: thomas.langlois@univ-tlse2.fr.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sanchez-Rodriguez', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bourcier', 'Affiliation': 'CHU Toulouse Purpan, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lamy', 'Affiliation': 'Centre médical la Villanelle, Cornebarrieu, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Callahan', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Université de Montréal, Montréal, Canada.'}]",Psychiatry research,['10.1016/j.psychres.2020.113159']
1280,32542307,Effect of daily 2000 IU versus 800 IU vitamin D on blood pressure among adults age 60 years and older: a randomized clinical trial.,"BACKGROUND


Observational studies report higher blood pressure (BP) among individuals with lower 25-hydroxyvitamin D concentration. Whether dosage of vitamin D supplementation has a differential effect on BP control remains unclear.
OBJECTIVE


The study aimed to determine if daily vitamin D supplementation with 2000 IU is more effective than 800 IU for BP control among older adults.
METHODS


This randomized, double-blind, ancillary trial of the Zurich Multiple Endpoint Vitamin D Trial in Knee Osteoarthritis enrolled adults aged ≥60 y who underwent elective surgery due to severe knee osteoarthritis. Participants were randomly assigned to receive high dose (2000 IU) or standard dose (800 IU) daily vitamin D3 for 24 mo. Outcomes included daytime and 24-h mean systolic BP. BP variability and serum 25-hydroxyvitamin D concentration were examined in a post hoc and observational analysis.
RESULTS


Of the 273 participants randomly assigned, 250 participants completed a follow-up 24-h ambulatory BP monitoring (mean age: 70.4 ± 6.4 y; 47.2% men). The difference in daytime mean systolic BP reduction between the 2000 IU (n = 123) and 800 IU (n = 127) groups was not statistically significant (-2.75 mm Hg vs. -3.94 mm Hg; difference: 1.18 mm Hg; 95% CI: -0.68, 3.05; P = 0.21), consistent with 24-h mean systolic BP. However, systolic BP variability was significantly reduced with 2000 IU (average real variability: -0.37 mm Hg) compared to 800 IU vitamin D3 (0.11 mm Hg; difference: -0.48 mm Hg; 95% CI: -0.94, -0.01; P = 0.045). Independent of group allocation, maximal reductions in mean BP were observed at 28.7 ng/mL of achieved serum 25-hydroxyvitamin D concentrations.
CONCLUSIONS


While daily 2000 IU and 800 IU vitamin D3 reduced mean systolic BP over 2 y to a small and similar extent, 2000 IU reduced mean systolic BP variability significantly more compared with 800 IU. However, without a placebo control group we cannot ascertain whether vitamin D supplementation effectively reduces BP.This trial was registered at www.clinicaltrials.gov as NCT00599807.",2020,"However, systolic BP variability was significantly reduced with 2000 IU (average real variability: -0.37 mm Hg) compared to 800 IU vitamin D3 (0.11 mm Hg; difference: -0.48 mm Hg; 95% CI:","['older adults', 'individuals with lower 25-hydroxyvitamin D concentration', 'Knee Osteoarthritis enrolled adults aged ≥60 y who underwent elective surgery due to severe knee osteoarthritis', 'adults age 60 years and older', '273 participants randomly assigned', '250 participants completed a follow-up 24-h ambulatory BP monitoring (mean age: 70.4\xa0±\xa06.4 y; 47.2% men']","['daily vitamin D supplementation', '800 IU vitamin D', 'Zurich Multiple Endpoint Vitamin D Trial', 'vitamin D supplementation', 'vitamin D3']","['blood pressure', 'mean BP', '24-h mean systolic BP', 'daytime and 24-h mean systolic BP', 'systolic BP variability', 'BP variability and serum 25-hydroxyvitamin D concentration', 'blood pressure (BP', 'mean systolic BP', 'mean systolic BP variability', 'serum 25-hydroxyvitamin D concentrations', 'daytime mean systolic BP reduction']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",273.0,0.705876,"However, systolic BP variability was significantly reduced with 2000 IU (average real variability: -0.37 mm Hg) compared to 800 IU vitamin D3 (0.11 mm Hg; difference: -0.48 mm Hg; 95% CI:","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Abderhalden', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Meyer', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Ursina', 'Initials': 'U', 'LastName': 'Meyer', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'de Godoi Rezende Costa Molino', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hannes B', 'Initials': 'HB', 'LastName': 'Stähelin', 'Affiliation': 'Department of Geriatrics, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'Department of Cardiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Forman', 'Affiliation': ""Department of Nephrology, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': 'Department of Nutrition, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa145']
1281,32554133,A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial.,"INTRODUCTION


We investigated whether a web-based cognitive training video game is an effective approach to improve cognitive decline in combination with our standard of care for rehabilitation of breast cancer (BC) patients.
MATERIALS AND METHODS


Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied. The patients received access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™). The early intervention group (n = 23) had a training program of 6 months of at least three times a week for a minimum of 60 min of game playing per week at home in addition to standard of care rehabilitation. The delayed intervention (n = 23) received standard of care for three months, followed by three months of similar MyCQ training. Outcome measures were the MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests.
RESULTS


At baseline the means for CFQ (a measure of self-reported cognitive failure), anxiety, PSQI and self-reflectiveness were beyond normal range in both groups. CFQ improved significantly better in the intervention group (p = 0.029). Combining the evolution over time in the entire population a significant improvement was seen for overall MyCQ score, level of fear, physical and emotional role limitation, and health change (all p < 0.05), but self-reflectivess deteriorated (p < 0.05)). Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N back 1 and 2 (all p < 0.05).
CONCLUSION


A program of cognitive training improves cognitive functioning over time. ""Aquasnap"" has a beneficial effect on the perception of subjective cognitive functioning (CFQ) but the exact role of video gaming in this process remains uncertain.",2020,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","['Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied', 'breast cancer (BC) patients', 'breast cancer survivors with cognitive impairment']","['video-game based cognitive training', 'cognitive training', 'web-based cognitive training video game', 'MyCQ training', 'access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™']","['speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N', 'cognitive failure), anxiety, PSQI and self-reflectiveness', 'cognitive functioning', 'MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests', 'overall MyCQ score, level of fear, physical and emotional role limitation, and health change', 'CFQ']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0411642,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellens', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Roelant', 'Affiliation': 'Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, University of Antwerp, Edegem, B2650, Belgium; StatUa, Center for Statistics, University of Antwerp, Antwerp, B2000, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Sabbe', 'Affiliation': 'Department of Psychiatry, Antwerp University, Wilrijk, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'van Dam', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium. Electronic address: peter.vandam@telenet.be.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.003']
1282,32554173,Neuroendocrine biomarkers of prolonged exposure treatment response in military-related PTSD.,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone. Preliminary evidence from animal models suggests that baseline levels of these biomarkers may predict response to PTSD treatment. We report the change in biomarkers over the course of PTSD treatment. Biomarkers were sampled from individuals participating in (1) a randomized controlled trial comparing a web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT) and (2) from individuals participating in a nonrandomized effectiveness study testing PE delivered in-person as part of an intensive outpatient PTSD program. We found that higher cortisol reactivity during script-driven imagery was associated with higher baseline PTSD severity and that baseline allopregnanolone, pregnanolone, and cortisol reactivity were associated with degree of symptom change over the course of intensive outpatient treatment. These findings demonstrate that peripherally assessed biomarkers are associated with PTSD severity and likelihood of successful treatment outcome of PE delivered daily over two weeks. These assessments could be used to determine which patients are likely to respond to treatment and which patients require augmentation to increase the likelihood of optimal response to PTSD treatment.",2020,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","['military-related PTSD', 'Posttraumatic stress disorder (PTSD']","['web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT', 'pregnanolone']",['higher cortisol reactivity'],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033008', 'cui_str': '3 alpha, 5 beta-Tetrahydroprogesterone'}]","[{'cui': 'C0541847', 'cui_str': 'Cortisol increased'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0279829,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: sheila.a.m.rauch@emory.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sripada', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, USA. Electronic address: rekaufma@med.umich.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Burton', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: mark.steven.burton@emory.edu.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Michopoulos', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: vmichop@emory.edu.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kerley', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: kimberly.kerley@emory.edu.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Marx', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: christine.marx@duke.edu.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Kilts', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jason.kilts@duke.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Naylor', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jennifer.naylor@duke.edu.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: brothba@emory.edu.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Rd, Menlo Park, CA, 94025, USA; Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 291 Campus Dr., Stanford, CA, 94305, USA. Electronic address: Carmen.McLean4@va.gov.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Emory University School of Medicine, Department of Obstetrics and Gynecology, 101 Woodruff Circle NE, Ste 4217, Atlanta, 30322, USA. Electronic address: alicia.smith@emory.edu.'}, {'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Norrholm', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: SNorrholm@wayne.edu.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: tjovanovic@med.wayne.edu.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'Texas A&M University, 8447 Riverside Parkway, Bryan, TX, 77808-3260, USA. Electronic address: liberzon@tamu.edu.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Williamson', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: douglas.williamson@duke.edu.'}, {'ForeName': 'Col Jeffrey S', 'Initials': 'CJS', 'LastName': 'Yarvis', 'Affiliation': 'Carl R. Darnall Army Medical Center, Department of Behavioral Health, 36065 Santa Fe Ave., Fort Hood, TX, 76544, USA. Electronic address: jeffrey.s.yarvis.mil@mail.mil.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'VA Boston Healthcare System, National Center for PTSD (116B-2), 150 South Huntington Avenue, Boston, MA, 02130, USA; Boston University School of Medicine, Department of Psychiatry, 720 Harrison Avenue, Room 906, Boston, MA, 02118, USA. Electronic address: Terry.Keane@va.gov.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA; South Texas Veterans Health Care System, Research and Development Service, 7400 Merton Minter, San Antonio, TX, 78229, USA; University of Texas at San Antonio, Department of Psychology, One UTSA Circle, San Antonio, TX, 78249, USA. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104749']
1283,32561410,Computer-aided detection-assisted colonoscopy: classification and relevance of false positives.,"BACKGROUND AND AIMS


False positive (FP) results by computer-aided detection (CADe) hamper the efficiency of colonoscopy by extending examination time. Our aim was to develop a classification of the causes and clinical relevance of CADe FPs, and to assess the relative distribution of FPs in a real-life setting.
METHODS


In a post-hoc analysis of a randomized trial comparing colonoscopy with and without CADe (NCT: 04079478), we extracted 40 CADe colonoscopy videos. Using a modified Delphi process, 4 expert endoscopists identified the main domains for the reasons and clinical relevance of FPs. Then, 2 expert endoscopists manually examined each FP and classified it according to the proposed domains. The analysis was limited to the withdrawal phase.
RESULTS


The 2 main domains for the causes of CADe FPs were identified as artifacts due to either the mucosal wall or bowel content, and clinical relevance was defined as the time spent on FPs and the FP rate per minute. The mean number of FPs per colonoscopy was 27.3 ± 13.1, of which 24 ± 12 (88%) and 3.2 ± 2.6 (12%) were due to artifacts in the bowel wall and bowel content, respectively. Of the 27.3 FPs per colonoscopy, 1.6 (5.7%) required additional exploration time of 4.8 ± 6.2 seconds per FP (ie, 0.7% of the mean withdrawal time). In detail, 15 (24.2%), 33 (53.2%), and 14 (22.6%) FPs were classified as being of mild, moderate, or severe clinical relevance. The rate of FPs per minute of withdrawal time was 2.4 ± 1.2, and was higher for FPs due to artifacts from the bowel wall than for those from bowel content (2.4 ± 0.6 vs 0.3 ± 0.2, P < .001).
CONCLUSIONS


FPs by CADe are primarily due to artifacts from the bowel wall. Despite a high frequency, FPs result in a negligible 1% increase in the total withdrawal time because most of them are immediately discarded by the endoscopist.",2020,"Of the 27.3 FP per colonoscopy, 1.6 (5.7%) required an additional exploration time of 4.8 ± 6.2 seconds per FP, ie, 0.7% of the mean withdrawal time (WT).",[],"['colonoscopy with and without CADe (NCT', 'Computer-aided detection-assisted colonoscopy']","['mean withdrawal time (WT', 'Mean FPs per colonoscopy', 'Rate of FP per minute of WT', 'total withdrawal time', 'causes of CADe-FPs']",[],"[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",,0.0532188,"Of the 27.3 FP per colonoscopy, 1.6 (5.7%) required an additional exploration time of 4.8 ± 6.2 seconds per FP, ie, 0.7% of the mean withdrawal time (WT).","[{'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Hassan', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Badalamenti', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Maselli', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Correale', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Iannone', 'Affiliation': 'Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of ""Aldo Moro"" of Bari, Bari.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Radaelli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Rondonotti', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Ferrara', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spadaccini', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Alkandari', 'Affiliation': 'Thanyan Alghanim Center for Gastroenterology and Hepatology, Alamiri Hospital, Kuwait City, Kuwait.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fugazza', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderloni', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Piera Alessia', 'Initials': 'PA', 'LastName': 'Galtieri', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Pellegatta', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Carrara', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Di Leo', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Craviotto', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lamonaca', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lorenzetti', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Andrealli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Antonelli', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Kansas City Veterans Affairs Hospital, Kansas City, Kansas, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rösch', 'Affiliation': 'Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Repici', 'Affiliation': 'Humanitas Clinical and Research Center IRCCS, Digestive Endoscopy Unit, Division of Gastroenterology, Rozzano, Milan; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.06.021']
1284,32566130,Toward a paradigm shift from deficit-based to proactive speech and language treatment: Randomized pilot trial of the Babble Boot Camp in infants with classic galactosemia.,"Background:  Speech and language therapy is typically initiated reactively after a child shows delays. Infants with classic galactosemia (CG), a metabolic disease with a known high risk for both speech and language disorders, hold the keys towards evaluating whether preventive treatment is effective when the risks are known at birth. We present pilot data from a randomized parallel trial of an innovative proactive speech and language intervention program, the Babble Boot Camp (BBC).   Method : Five children with CG, otherwise healthy, participated in the study from approximately 2 to 24 months of age. One of these was randomly selected as control receiving conventional management, which typically starts at age 2-3 years. A pediatric speech-language pathologist met weekly via telepractice with the parents in the treatment cohort. Parents implemented the prespeech, speech, and language stimulation and expansion activities according to the intervention protocol. The control child was still too young for conventional treatment. Primary outcome measures were speech sound production complexity in babble and speech and expressive vocabulary size. Secondary outcome measures were vocalization rates and developmental milestones in communication, motor, and cognition. The trial is ongoing.  Results :  All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, three had higher global developmental scores, and two had higher vocalization rates, compared to the control child with CG.  Discussion:  Given the high risk for speech and language delays in children with CG, finding on-schedule abilities in two or more of the treated children but not the untreated child is unexpected under random conditions. The trends toward beneficial effects of the BBC on speech sound production, expressive language, and communication milestones warrant appropriately powered larger clinical trials with full randomization.  Trial registration:  ClinicalTrials.gov NCT03838016 (12  th  February 2019).",2019,"All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, and three had higher communication and personal-social skills, compared to the control child with CG.  ","['infants with classic galactosemia', 'children with CG', 'Infants with classic galactosemia (CG', 'Method : Five children with CG, otherwise healthy, participated in the BBC from approximately 2 to 24 months of age']","['Babble Boot Camp', 'proactive speech and language treatment', 'control receiving conventional management', 'innovative proactive speech and language intervention program, the Babble Boot Camp (BBC', ':  Speech or language therapy']","['speech sound production, expressive language, and communication milestones', 'developmental milestones in communication, motor, and cognition', 'speech sound production complexity in babble and speech and expressive vocabulary size', 'higher communication and personal-social skills', 'higher speech sound skills', 'prespeech, speech, and language stimulation and expansion activities']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0268151', 'cui_str': 'Deficiency of UDPglucose-hexose-1-phosphate uridylyltransferase'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0856983', 'cui_str': 'Babbling'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023017', 'cui_str': 'Language therapy'}]","[{'cui': 'C0037829', 'cui_str': 'Speech Sounds'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0856983', 'cui_str': 'Babbling'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0589217', 'cui_str': 'Language stimulation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",5.0,0.032084,"All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, and three had higher communication and personal-social skills, compared to the control child with CG.  ","[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Peter', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Potter', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Donenfeld-Peled', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Finestack', 'Affiliation': 'Department of Speech-Language-Hearing Services, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stoel-Gammon', 'Affiliation': 'Department of Speech and Hearing Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lien', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Bruce', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Vose', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Eng', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Olds', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'VanDam', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}]",F1000Research,['10.12688/f1000research.18062.5']
1285,32567654,"Impact of Succinct Training on Open Cricothyrotomy Performance: A Randomized, Prospective, Observational Study of U.S. Army First Responders.","INTRODUCTION


Primary airway failure has become the second most common cause of potentially survivable battlefield fatality. Cricothyrotomy is taught to all U.S. military providers as a means of securing an airway in extremis. However, retrospective studies show that cricothyrotomy failure rates for U.S. military first responders performing the procedure in combat is 33%. Our hypothesis was that these rates could be improved.
MATERIALS AND METHODS


We conducted a randomized, prospective, observational study to evaluate the effects of inexpensive, succinct training on open cricothyrotomy performance by studying two unique U.S. Army First Responder participant groups. One participant group consisted of regular U.S. Army Medics (68 Ws). The second group was Special Operations Combat Medics. We evaluated both groups' baseline ability to correctly perform a cricothyrotomy and then randomly assigned individuals within each group to either a training or practice group.
RESULTS


The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline.
CONCLUSION


With one manikin, a qualified trainer, and $35 worth of expendable supplies, 10 medics could be trained in the procedure in just 2-3 hours. Our study suggests that this simple intervention has the potential to significantly improve U.S. Army First Responders' ability to correctly perform an open cricothyrotomy and drastically decrease the time needed to perform this lifesaving procedure correctly, possibly saving one in four potentially survivable combat casualties suffering from airway compromise.",2020,"The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline.
",[],"['training or practice group', 'regular U.S. Army Medics', 'Cricothyrotomy', 'Succinct Training', 'inexpensive, succinct training']","['procedural success rates', 'Open Cricothyrotomy Performance', 'average time-to-correct-placement']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030450', 'cui_str': 'Paramedical Personnel'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.0179072,"The training group had a higher proportion of success and performed the cricothyrotomy faster than the practice group with 68 Ws group appearing to benefit most from training: their procedural success rates increased by an average of 23%, and their average time-to-correct-placement decreased by 21 seconds-a 33% improvement over baseline.
","[{'ForeName': 'Kurtis L', 'Initials': 'KL', 'LastName': 'Muller', 'Affiliation': 'Special Warfare Medical Group (Airborne) 1975 Combat Medic Rd, Fort Bragg NC 28310.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Facciolla', 'Affiliation': '1st Special Forces Command (Airborne) 1625 Reilly Rd, Fort Bragg, NC 28310.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Monti', 'Affiliation': 'Madigan Army Medical Center 9040A Jackson Ave, Joint Base Lewis-McChord, WA 98431.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Cronin', 'Affiliation': 'Madigan Army Medical Center 9040A Jackson Ave, Joint Base Lewis-McChord, WA 98431.'}]",Military medicine,['10.1093/milmed/usaa035']
1286,32565333,In Vivo Evaluation of Effect of Preoperative Ibuprofen on Proinflammatory Mediators in Irreversible Pulpitis Cases.,"INTRODUCTION


Preoperative administration of nonsteroidal anti-inflammatory drugs has been suggested as a method for increasing the efficacy of local anesthetics and decreasing postoperative pain in symptomatic irreversible pulpitis cases. However, the effects of ibuprofen at the molecular level are still unknown. Hence, the purpose of this study was to compare the levels of proinflammatory mediators in the dental pulp of teeth with irreversible pulpitis in patients who medicated with preoperative ibuprofen versus those who did not.
METHODS


Thirty-four patients undergoing conventional endodontic therapy for teeth with irreversible pulpitis were selected and randomly assigned into either the ibuprofen or nonibuprofen group. Four patients undergoing endodontic therapy for prosthodontic reasons served as controls. Patients in the ibuprofen group were instructed to take 600 mg ibuprofen 1 hour before treatment, whereas patients in the nonibuprofen and control groups were asked to avoid analgesics before treatment. Blood samples obtained from the pulp upon access were tested for levels of prostaglandin E2, tumor necrosis efactor alpha, interleukin (IL)-6, IL-1β, and interferon gamma using high-sensitivity enzyme-linked immunosorbent assay. Postoperative pain levels were recorded for the groups. Data for the cytokine levels and postoperative pain were analyzed using statistical analysis.
RESULTS


There was a significant decrease in the levels of prostaglandin E2, tumor necrosis factor alpha, IL-6, and interferon gamma in the ibuprofen group compared with the nonibuprofen group. No significant differences were noted in the postoperative pain levels between these groups.
CONCLUSIONS


The data showed that preoperative ibuprofen significantly decreased the levels of most proinflammatory cytokines in the dental pulp, which could possibly help with anesthesia in irreversible cases.",2020,"There was a significant decrease in the levels of PGE2, TNF-α, IL-6, and IFN-γ in the ibuprofen group as compared to the non-ibuprofen group.","['irreversible pulpitis cases', 'Four patients undergoing', 'Thirty-four patients undergoing', 'for teeth with irreversible pulpitis', 'dental pulp of teeth with irreversible pulpitis in patients who medicated with pre-operative ibuprofen versus those who did not']","['pre-operative ibuprofen', 'ibuprofen or non-ibuprofen', 'conventional endodontic therapy', 'endodontic therapy', 'ibuprofen']","['post-operative pain levels', 'levels of PGE2, TNF-α, IL-6, and IFN-γ', 'levels of PGE2, TNF-α, IL-6, IL-1β and IFN-γ using high sensitivity ELISAs', 'Post-operative pain levels', 'cytokine levels and post-operative pain', 'levels of most pro-inflammatory cytokines']","[{'cui': 'C0399406', 'cui_str': 'Irreversible pulpitis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]",4.0,0.0251917,"There was a significant decrease in the levels of PGE2, TNF-α, IL-6, and IFN-γ in the ibuprofen group as compared to the non-ibuprofen group.","[{'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'Department of Endodontics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Yen-Wei', 'Initials': 'YW', 'LastName': 'Chen', 'Affiliation': 'Department of Restorative Dentistry, University of Washington, Seattle, Washington.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Johnson', 'Affiliation': 'Department of Endodontics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Avina', 'Initials': 'A', 'LastName': 'Paranjpe', 'Affiliation': 'Department of Endodontics, University of Washington, Seattle, Washington. Electronic address: avina@uw.edu.'}]",Journal of endodontics,['10.1016/j.joen.2020.06.009']
1287,32572510,Evaluation of the Sensitivity of the Nipple-Areola Complex in Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release: A Randomized Controlled Trial.,"BACKGROUND


In the surgical treatment of breast ptosis, the plastic surgeon's main challenge is to mobilize the nipple-areola complex (NAC) over long distances, preserving its sensitivity. Herein, we aimed to evaluate the NAC sensitivity following a periareolar dermis release in patients undergoing surgical correction of breast ptosis.
METHODS


This is a prospective, double-blinded, randomized study in which 39 patients (78 breasts) were operated on for the treatment of breast ptosis. Patients' breasts were divided into two groups, each breast in a group. In breasts of the experiment group, the periareolar dermis release was used after decortication. This maneuver was not used in the control group's breasts. To analyze the sensitivity in relation with the distance that the NAC should be mobilized to correct breast ptosis, the value of 6 cm was used as boundary. Sensitivity of the NAC was assessed with monofilaments preoperatively and postoperatively-at three and six weeks and one year.
RESULTS


Regarding the sensitivity of the areola, a significant difference was observed in the comparison between the control and experiment groups at the NAC mobility ≤ 6.0 cm in the preoperative. Regarding the nipple, a significant difference was observed in the comparison between the control and experiment groups at three weeks postoperatively for a NAC mobility ≤ 6.0 cm. After one year, there was no difference in the comparison between the groups in either areola or nipple.
CONCLUSION


The periareolar dermis release does not compromise NAC vascularization and pressure sensitivity in patients undergoing breast ptosis correction.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,"The periareolar dermis release does not compromise NAC vascularization and pressure sensitivity in patients undergoing breast ptosis correction.
","['39 patients (78 breasts', ""Patients' breasts"", 'Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release', 'patients undergoing surgical correction of breast ptosis', 'patients undergoing breast ptosis correction']",[],"['Sensitivity of the NAC', 'NAC sensitivity', 'periareolar dermis release']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",[],"[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",,0.0314583,"The periareolar dermis release does not compromise NAC vascularization and pressure sensitivity in patients undergoing breast ptosis correction.
","[{'ForeName': 'Jairo Zacchê', 'Initials': 'JZ', 'LastName': 'Sá', 'Affiliation': 'Plastic Surgery Unit, Hospital das Clínicas, Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Santa Cruz Oliveira', 'Affiliation': 'School of Medicine, Federal University of Pernambuco, Av. Prof. Moraes Rego, 1235 - Cidade Universitária, Recife, PE, 50670-901, Brazil. f.santacruzoliveira@gmail.com.'}, {'ForeName': 'William Flávio', 'Initials': 'WF', 'LastName': 'Santinoni', 'Affiliation': 'Plastic Surgery Unit, Hospital das Clínicas, Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Freire', 'Affiliation': 'School of Medicine, Federal University of Pernambuco, Av. Prof. Moraes Rego, 1235 - Cidade Universitária, Recife, PE, 50670-901, Brazil.'}, {'ForeName': 'Amanda Estelita', 'Initials': 'AE', 'LastName': 'de Oliveira Rodrigues', 'Affiliation': 'Department of Physiotherapy, Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'José Lamartine', 'Initials': 'JL', 'LastName': 'de Andrade Aguiar', 'Affiliation': 'Experimental Surgery Unit, Hospital das Clínicas, Federal University of Pernambuco, Recife, PE, Brazil.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01835-7']
1288,32544846,"A fructose-based meal challenge to assess metabotypes and their metabolic risk profile: A randomized, crossover, controlled trial.","OBJECTIVES


The first aim of this study was to determine the metabolic type of individuals based on the postprandial metabolic response after the ingestion of a meal challenge that was high protein and either high glucose (high GI) or fructose (low GI). The second aim was to compare the baseline characteristics between the different metabolic types (metabotypes). The third aim was to assess whether the inclusion of fructose or glucose in a high-protein breakfast modulated the glucose, insulin, and TG response over a 4-h period.
METHODS


The study included 46 Asian women with a body mass index between 17 and 28 kg/m 2  in a randomized crossover design. Metabolic typing was based on the assessment of the postprandial glycemic, insulin and triacylglycerol (TG) response after the ingestion of two high-protein meal challenges either high in fructose or glucose. Baseline characteristics were compared between the different metabolic types. Baseline and 4-h postprandial blood samples were collected and glucose, insulin, and TG levels were analyzed. Cluster analysis was used to phenotype the participants in distinct groups. Baseline characteristics including anthropometry, glycemic, and lipid profiles and resting metabolic rate were compared among the metabolic types.
RESULTS


Cluster analysis revealed that women could be grouped into three metabolic types based on postprandial glucose, insulin, and TG response after the fructose meal challenge: cluster 1 with an average glucose + high TG response (highTG; n = 12), cluster 2 with a high glucose + average TG response (highGLU; n = 8), and cluster 3 with an average glucose + average TG response (Avg; n = 26). Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
CONCLUSIONS


Three metabolic types with a distinct metabolic response could be distinguished after a high fructose meal. The results suggest a different risk profile and may indicate why some people develop diabetes in an obesogenic environment. Improved metabolic-type assessments will enable us to develop and optimize nutritional and medical interventions for individuals with differing diabetes risk.",2020,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","['46 Asian women with a body mass index between 17 and 28 kg/m 2', 'individuals with differing diabetes risk']","['high glucose (high GI) or fructose (low GI', 'fructose-based meal challenge']","['waist-to-hip ratio', 'fasting blood glucose, body mass index, fat percentage, and hip circumference', 'glucose, insulin, and TG levels', 'glucose, insulin, and TG response', 'postprandial glycemic, insulin and triacylglycerol (TG) response', 'Baseline and 4-h postprandial blood samples', 'postprandial glucose, insulin, and TG response', 'anthropometry, glycemic, and lipid profiles and resting metabolic rate', 'postprandial metabolic response']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}]",46.0,0.0341195,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","[{'ForeName': 'Stefan Gerardus', 'Initials': 'SG', 'LastName': 'Camps', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Huann Rong', 'Initials': 'HR', 'LastName': 'Koh', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Nan Xin', 'Initials': 'NX', 'LastName': 'Wang', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore; Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: jeya_henry@sifbi.a-star.edu.sg.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110799']
1289,32553835,Reductions in Parent Interest in Receiving Antibiotics following a 90-Second Video Intervention in Outpatient Pediatric Clinics.,"OBJECTIVES


To assess the impact of a 90-second animated video on parents' interest in receiving an antibiotic for their child.
STUDY DESIGN


This pre-post test study enrolled English and Spanish speaking parents (n = 1051) of children ages 1-5 years presenting with acute respiratory tract infection symptoms. Before meeting with their provider, parents rated their interest in receiving an antibiotic for their child, answered 6 true/false antibiotic knowledge questions, viewed the video, and then rated their antibiotic interest again. Parents rated their interest in receiving an antibiotic using a visual analogue scale ranging from 0 to 100, with 0 being ""I definitely do not want an antibiotic,"" 50 ""Neutral,"" and 100 ""I absolutely want an antibiotic.""
RESULTS


Parents were 84% female, with a mean age of 32 ± 6.0, 26.0% had a high school education or less, 15% were black, and 19% were Hispanic. After watching the video, parents' average antibiotic interest ratings decreased by 10 points (mean, 57.0 ± 20 to M ± 21; P < .0001). Among parents with the highest initial antibiotic interest ratings (≥60), even greater decreases were observed (83.0 ± 12.0 to 63.4 ± 22; P < .0001) with more than one-half (52%) rating their interest in the low or neutral ranges after watching the video.
CONCLUSIONS


A 90-second video can decrease parents' interest in receiving antibiotics, especially among those with higher baseline interest. This scalable intervention could be used in a variety of settings to reduce parents' interest in receiving antibiotics.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03037112.",2020,"Among parents with the highest initial antibiotic interest ratings (>60), even larger reductions were observed (M=83.0, SD=12 to M=63.4, SD=22; p<.0001) with over half (52%) rating their interest in the low or neutral ranges after watching the video.
","['This pre-post test study enrolled English and Spanish speaking parents (n=1051) of children ages 1-5 years presenting with acute respiratory tract infection symptoms', 'Parents were 84% female, mean age 32 (SD=6.0), 26.0% had a high school education or less, 15% Black, and 19% Hispanic', ""parents' interest in receiving an antibiotic for their child"", 'Outpatient Pediatric Clinics']",['90-second animated video'],[],"[{'cui': 'C0032919', 'cui_str': 'Pre-Post Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",[],,0.0489348,"Among parents with the highest initial antibiotic interest ratings (>60), even larger reductions were observed (M=83.0, SD=12 to M=63.4, SD=22; p<.0001) with over half (52%) rating their interest in the low or neutral ranges after watching the video.
","[{'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO; University of Missouri - Kansas City School of Medicine, Kansas City, MO; University of Missouri - Kansas City School of Pharmacy, Kansas City, MO. Electronic address: kgoggin@cmh.edu.""}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Hurley', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO; University of Missouri - Kansas City School of Medicine, Kansas City, MO.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO.""}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Bickford', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO.""}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Lee', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO; University of Missouri - Kansas City School of Medicine, Kansas City, MO.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Pina', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO.""}, {'ForeName': 'Evelyn Donis', 'Initials': 'ED', 'LastName': 'De Miranda', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mackenzie', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Sunflower Medical Group, Kansas City, MO.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Weltmer', 'Affiliation': 'University of Missouri - Kansas City School of Medicine, Kansas City, MO.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, Santa Monica, CA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': ""University of Missouri - Kansas City School of Medicine, Kansas City, MO; Emergency Department, Children's Mercy, Kansas City, MO.""}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Newland', 'Affiliation': ""Pediatric Infectious Disease, St. Louis Children's Hospital, St. Louis, MO.""}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Myers', 'Affiliation': ""University of Missouri - Kansas City School of Medicine, Kansas City, MO; Pediatric Infectious Diseases, Children's Mercy, Kansas City, MO.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.027']
1290,32553836,Early Weight Gain Forecasts Accelerated Eruption of Deciduous Teeth and Later Overweight Status during the First Year.,"OBJECTIVES


To determine whether early diet and weight gain velocity have independent or interactive effects on deciduous teeth emergence and overweight status during the first year.
STUDY DESIGN


Monthly measures of anthropometry and teeth eruption were collected during a 1-year trial (0.5-12.5 months) on formula-fed infants in which the type of randomized infant formula (cow milk or extensively hydrolyzed protein) diet significantly affected early (0.5-4.5 months) weight gain velocity. Generalized linear mixed models determined whether early diet and weight gain velocity had independent or interactive effects on timing and pattern of teeth eruption. Data from a trial on breastfed infants were used to explore effects of breast milk vs infant formula diets on teeth eruption and overweight status at 10.5 months.
RESULTS


Independent of infant formula diet, velocities of weight gain had direct effects on the age of first deciduous tooth (P < .04) and number of erupted teeth over time (P < .002). Greater velocity of weight gain from 0.5 to 4.5 months caused earlier and more frequent eruption of deciduous teeth from 4.5 to 12.5 months. Exploratory follow-up analyses on the breastfed and formula-fed diet groups found early weight gain velocity (P = .001), but not diet or its interaction, had significant effects. Infants in the upper quartile for weight gain velocity had more primary teeth (P = .002), and a greater proportion of them were overweight (P < .001) at 10.5 months.
CONCLUSIONS


Faster weight gain accretion forecasted accelerated primary teeth eruption and increased percentage of children who were overweight-risk factors for dental caries and obesity.
TRIAL REGISTRATION


ClinicalTrials.govNCT01700205 [2012-2015] and NCT01667549 [2012-2015].",2020,"Exploratory follow-up analyses on the BF and FF diet groups found early weight gain velocity (P=0.001), but not diet or its interaction, had significant effects.",[],"['formula-fed (FF) infants in which the type of randomized infant formula (cow milk or extensively hydrolyzed protein) diet', 'breast milk versus infant formula diets']","['Greater velocity of weight gain', 'frequent eruption of deciduous teeth', 'weight gain velocity', 'teeth eruption and overweight status']",[],"[{'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0040437', 'cui_str': 'Tooth erupted'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0416378,"Exploratory follow-up analyses on the BF and FF diet groups found early weight gain velocity (P=0.001), but not diet or its interaction, had significant effects.","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Mennella', 'Affiliation': 'Monell Chemical Senses Center, Philadelphia, PA. Electronic address: mennella@monell.org.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Reiter', 'Affiliation': 'Monell Chemical Senses Center, Philadelphia, PA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brewer', 'Affiliation': 'University of Delaware, Newark, DE.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Pohlig', 'Affiliation': 'University of Delaware, Newark, DE.'}, {'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ""Children's Hospital of Philadelphia, Division of Gastroenterology, Hepatology and Nutrition, Philadelphia, PA.""}, {'ForeName': 'Jillian C', 'Initials': 'JC', 'LastName': 'Trabulsi', 'Affiliation': 'University of Delaware, Newark, DE.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.019']
1291,32553868,"Synthetic Surfactant CHF5633 Compared with Poractant Alfa in the Treatment of Neonatal Respiratory Distress Syndrome: A Multicenter, Double-Blind, Randomized, Controlled Clinical Trial.","OBJECTIVE


To compare efficacy and safety of a new synthetic surfactant, CHF5633, enriched with surfactant proteins, SP-B and SP-C peptide analogues, with porcine surfactant, poractant alfa, for the treatment of respiratory distress syndrome in infants born preterm.
STUDY DESIGN


Neonates born preterm on respiratory support requiring fraction of inspired oxygen (FiO 2 ) ≥0.30 from 24 0/7  to 26 6/7  weeks and FiO 2  ≥0.35 from 27 0/7  to 29 6/7  weeks of gestation to maintain 88%-95% oxygen saturation were randomized to receive 200 mg/kg of CHF5633 or poractant alfa. If necessary, redosing was given at 100 mg/kg. Efficacy end points were oxygen requirement (FiO 2 , respiratory severity score [FiO 2  × mean airway pressure]) in the first 24 hours, 7 and 28 days, discharge home, and/or 36 weeks of postmenstrual age; mortality and bronchopulmonary dysplasia at 28 days and 36 weeks of PMA. Adverse events and immunogenicity were monitored for safety.
RESULTS


Of the 123 randomized neonates, 113 were treated (56 and 57 in CHF5633 and poractant alfa groups, respectively). In both arms, FiO 2  and respiratory severity score decreased from baseline at all time points (P < .001) with no statistically significant differences between groups. Rescue surfactant use (19 [33.9%] vs 17 [29.8%]), bronchopulmonary dysplasia (31 [55.4%] and 32 [56.1%]), and mortality at day 28 (4 [7.1%] and 3 [5.3%]) were similar in the CHF5633 and poractant alfa groups, respectively. In 2 (3.4%) and 1 (1.7%) neonates, adverse drug reactions were reported in CHF5633 and poractant alfa groups, respectively. No immunogenicity was detected.
CONCLUSIONS


Treatment with CHF5633 showed similar efficacy and safety as poractant alfa in neonates born preterm with moderate-to-severe respiratory distress syndrome.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02452476.",2020,In both arms FiO 2  and RSS decreased from baseline at all timepoints (P < .001) with no statistically significant differences between groups.,"['Preterm neonates on respiratory support requiring fraction of inspired oxygen (FiO 2 ', 'respiratory distress syndrome (RDS) in preterm infants', '123 randomized neonates', 'preterm neonates with moderate to severe RDS', '≥0.30 from 24 0/7  to 26 6/7  weeks and FiO 2  ≥0.35 from 27 0/7  to 29 6/7  weeks gestation to maintain 88-95% oxygen saturation', 'Neonatal Respiratory Distress Syndrome']","['CHF5633 or PA', 'Poractant Alfa', 'CHF5633', 'Synthetic Surfactant CHF5633', 'new synthetic surfactant, CHF5633, enriched with surfactant proteins, SP-B and SP-C peptide analogues, with porcine surfactant, poractant alfa']","['BPD', 'adverse drug reactions', 'discharge home and/or 36-week postmenstrual age, mortality and bronchopulmonary dysplasia (BPD', 'efficacy and safety', 'mortality', 'Adverse events and immunogenicity', 'RSS', 'oxygen requirement [FiO 2 , Respiratory Severity Score (RSS) (FiO 2  x mean airway pressure']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]","[{'cui': 'C3885750', 'cui_str': 'CHF5633'}, {'cui': 'C0771648', 'cui_str': 'Poractant alfa'}, {'cui': 'C0038891', 'cui_str': 'Surfactant'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3544277', 'cui_str': 'Surfactant protein'}, {'cui': 'C0630744', 'cui_str': 'substance P, cyclo(H-Glu-Phe-Phe-Gly-Leu-Met-NH(CH2)3-NH-)'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}]","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]",,0.338415,In both arms FiO 2  and RSS decreased from baseline at all timepoints (P < .001) with no statistically significant differences between groups.,"[{'ForeName': 'Rangasamy', 'Initials': 'R', 'LastName': 'Ramanathan', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, LAC+USC Medical Center and Good Samaritan Hospital, Keck School of Medicine of USC, Los Angeles, CA. Electronic address: ramanath@usc.edu.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Biniwale', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, LAC+USC Medical Center and Good Samaritan Hospital, Keck School of Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Oklahoma University Medical Center, Children's Hospital, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Nazeeh', 'Initials': 'N', 'LastName': 'Hanna', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, NYU Winthrop Hospital, NYU Long Island School of Medicine, New York, NY.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Golombek', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center, Hackensack, NJ.""}, {'ForeName': 'Jatinder', 'Initials': 'J', 'LastName': 'Bhatia', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, The Medical College of Georgia at Augusta University, Augusta, GA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Naylor', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Brody School of Medicine at East Carolina University, Greenville, NC.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fabbri', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Varoli', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Santoro', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Del Buono', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Piccinno', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Christiane E', 'Initials': 'CE', 'LastName': 'Dammann', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Floating Hospital for Children at Tufts Medical Center, Boston, MA.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.024']
1292,32559123,Highlighting Prosocial Affordances of Science in Textbooks to Promote Science Interest.,"The prevalent stereotype that scientific fields do not afford opportunities to fulfill goals of helping others deters student interest and participation in science. We investigated whether introductory college science textbooks that highlight the prosocial utility value of science can be used to change beliefs about the affordances of scientific work. In study 1, undergraduate students who were randomly assigned to read a science textbook chapter with added prosocial utility value expressed greater beliefs that the science topic afforded prosocial goals and increased interest in the scientific topic, compared with two control conditions. Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities. Multiple group comparison tests indicated that underrepresented minority students (i.e., African Americans, Latinos, and Native Americans) might benefit the most from efforts to strengthen prosocial affordance beliefs. In study 2, we conducted a brief landscape analysis of science textbooks and found that texts are missing opportunities to emphasize the prosocial utility value of science. We discuss recommendations for science educators, curriculum designers, and researchers who want to increase and broaden science participation.",2020,Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities.,"['underrepresented minority students (i.e., African Americans, Latinos, and Native Americans', 'undergraduate students']",['science textbook chapter with added prosocial utility value expressed greater beliefs that the science topic afforded prosocial goals'],[],"[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}]","[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039712', 'cui_str': 'Textbooks'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",[],,0.0293534,Mediation analysis demonstrated that interest was enhanced through increased beliefs that the topic afforded prosocial opportunities.,"[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Zambrano', 'Affiliation': 'Rossier School of Education, University of Southern California, Los Angeles, CA 90089-4035.'}, {'ForeName': 'Garam Ann', 'Initials': 'GA', 'LastName': 'Lee', 'Affiliation': 'College of Education, Michigan State University, East Lansing, MI 48824.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Leal', 'Affiliation': 'Warner School of Education, University of Rochester, Rochester, NY 14627.'}, {'ForeName': 'Dustin B', 'Initials': 'DB', 'LastName': 'Thoman', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA 92182.'}]",CBE life sciences education,['10.1187/cbe.19-09-0176']
1293,32559272,Exploring the effect of vitamin D3 supplementation on surrogate biomarkers of cholesterol absorption and endogenous synthesis in patients with type 2 diabetes-randomized controlled trial.,"BACKGROUND


Inverse associations have been reported between serum 25-hydroxyvitamin D [25(OH)D] and circulating cholesterol concentrations in observational studies. Postulated mechanisms include reduced bioavailability of intestinal cholesterol and alterations in endogenous cholesterol synthesis.
OBJECTIVE


To explore the effect of daily supplementation with 4000 IU/d vitamin D3 for 24 wk on surrogate biomarkers of cholesterol absorption (campesterol and β-sitosterol) and endogenous synthesis (lathosterol and desmosterol).
METHODS


Ancillary study of The Vitamin D for Established Type 2 Diabetes (DDM2) trial. Patients with established type 2 diabetes (N = 127, 25-75 y, BMI 23-42 kg/m2) were randomly assigned to receive either 4000 IU vitamin D3 or placebo daily for 24 wk. Of participants without changes in cholesterol-lowering medications (n = 114), plasma surrogate cholesterol absorption and endogenous synthesis biomarker concentrations were measured and merged with available measures of serum LDL cholesterol and HDL cholesterol concentrations.
RESULTS


At week 24, vitamin D3 supplementation significantly increased 25(OH)D concentrations (+21.5 ± 13.4 ng/mL) but not insulin secretion rates (primary outcome of the parent study) as reported previously. In this ancillary study there was no significant effect of vitamin D3 supplementation on serum cholesterol profile or surrogate biomarkers of cholesterol absorption and endogenous synthesis. Compared with participants not treated with cholesterol-lowering medications, those who were treated exhibited a greater reduction in plasma campesterol concentrations in the vitamin D3 but not placebo group (P-interaction = 0.011). Analyzing the data on the basis of cholesterol absorption status (hypo- versus hyperabsorbers) or cholesterol synthesis status (hypo- versus hypersynthesizers) did not alter these results.
CONCLUSIONS


Vitamin D3 supplementation for 24 wk had no significant effect on surrogate biomarkers of cholesterol absorption or endogenous synthesis, consistent with the lack of effect on serum cholesterol profile. Vitamin D3 supplementation resulted in greater reduction in campesterol concentrations in participants not using compared with those using cholesterol-lowering medications. Further studies are required.This trial was registered at clinicaltrials.gov as NCT01736865.",2020,Vitamin D3 supplementation resulted in greater reduction in campesterol concentrations in participants not using compared with those using cholesterol-lowering medications.,"['Patients with established type 2 diabetes (N\xa0=\xa0127, 25-75 y, BMI 23-42 kg/m2', 'Established Type 2 Diabetes (DDM2) trial', 'patients with type 2 diabetes']","['Vitamin D', '4000 IU vitamin D3 or placebo', 'daily supplementation with 4000 IU/d vitamin D3', 'vitamin D3 supplementation', 'Vitamin D3 supplementation', 'placebo']","['25(OH)D concentrations', 'serum cholesterol profile or surrogate biomarkers of cholesterol absorption and endogenous synthesis', 'insulin secretion rates', 'serum LDL cholesterol and HDL cholesterol concentrations', 'serum 25-hydroxyvitamin D [25(OH)D] and circulating cholesterol concentrations', 'cholesterol-lowering medications', 'plasma campesterol concentrations', 'plasma surrogate cholesterol absorption and endogenous synthesis biomarker concentrations', 'campesterol concentrations', 'serum cholesterol profile', 'cholesterol absorption (campesterol and β-sitosterol) and endogenous synthesis (lathosterol and desmosterol', 'cholesterol absorption and endogenous synthesis', 'surrogate biomarkers of cholesterol absorption or endogenous synthesis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0054560', 'cui_str': 'campesterol'}, {'cui': 'C0037215', 'cui_str': 'Sitosterols'}, {'cui': 'C0064673', 'cui_str': 'Lathosterol'}, {'cui': 'C0011704', 'cui_str': '24-Dehydrocholesterol'}]",,0.270391,Vitamin D3 supplementation resulted in greater reduction in campesterol concentrations in participants not using compared with those using cholesterol-lowering medications.,"[{'ForeName': 'Huicui', 'Initials': 'H', 'LastName': 'Meng', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Nirupa R', 'Initials': 'NR', 'LastName': 'Matthan', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Angellotti', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anastassios G', 'Initials': 'AG', 'LastName': 'Pittas', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa149']
1294,32562310,Impact of Phenol-Enriched Virgin Olive Oils on the Postprandial Levels of Circulating microRNAs Related to Cardiovascular Disease.,"SCOPE


We investigate the postprandial modulation of cardiovascular-related microRNAs elicited by extra virgin olive oil (EVOOs) containing different levels of their own polyphenols.
METHODS AND RESULTS


It is randomized, postprandial, parallel, double-blind study. Twelve healthy participants consumed 30 mL of EVOO containing low (L-EVOO; 250 mg total phenols kg -1  of oil), medium (M-EVOO; 500 mg total phenols kg -1  of oil), and high (H-EVOO; 750 mg total phenols kg -1  of oil) enriched EVOOs. Postprandial plasma microRNAs levels are analyzed by real-time quantitative PCR. The results show that L-EVOO intake is associated with decreased let-7e-5p and miR-328a-3p levels and increased miR-17-5p and miR-20a-5p, concentrations. M-EVOO decreases plasma let-7e-5p and increases miR-17-5p, miR-20a-5p, and miR-192-5p levels. Finally, H-EVOO decreases let-7e-5p, miR-10a-5p, miR-21-5p, and miR-26b-5p levels.
CONCLUSION


During the postprandial state, the levels of let-7e-5p decrease with EVOO regardless of polyphenol content suggesting a general response to the fatty acid composition of EVOO or/and the presence of at least 250 mg polyphenol kg -1  olive oil. Moreover, the miR-17-92 cluster increases by low and medium polyphenol content suggesting a role in fatty acid metabolism and nutrient sensing. Thus, postprandial modulation of circulating microRNAs levels could be a potential mechanism for the cardiovascular benefits associated with EVOO intake.",2020,"M-EVOO decreased plasma let-7e-5p and increased miR-17-5p, miR-20a-5p and miR-192-5p levels.",['12 healthy participants'],"['consumed 30\xa0mL of EVOO containing Low (L-EVOO; 250\xa0mg total phenols/kg of oil), Medium (M-EVOO; 500\xa0mg total phenols/kg of oil) and high (H-EVOO; 750\xa0mg total phenols/kg of oil) polyphenol', 'Extra Virgin Olive oil (EVOOs', 'Phenol-Enriched Virgin Olive Oils', 'polyphenol/kg olive oil']","['let-7e-5p and miR-328a-3p levels and increased miR-17-5p and miR-20a-5p, concentrations', 'Plasma microRNAs levels', 'L-EVOO intake', 'H-EVOO decreased let-7e-5p, miR-10a-5p, miR-21-5p and miR-26b-5p levels', 'M-EVOO decreased plasma let-7e-5p and increased miR-17-5p, miR-20a-5p and miR-192-5p levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C4517623', 'cui_str': '192'}]",12.0,0.125285,"M-EVOO decreased plasma let-7e-5p and increased miR-17-5p, miR-20a-5p and miR-192-5p levels.","[{'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Control of the Epigenome Group, Instituto Madrileño de Estudios, Avanzados (IMDEA) Food Institute, CEI UAM+CSIC, Madrid, 28049, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Micó', 'Affiliation': 'Nutritional Control of the Epigenome Group, Instituto Madrileño de Estudios, Avanzados (IMDEA) Food Institute, CEI UAM+CSIC, Madrid, 28049, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Valls', 'Affiliation': 'Functional Nutrition, Oxidation and Cardiovascular Disease Research Group, Universitat Rovira i Virgili, Hospital Universitari Sant Joan, EURECAT, Reus, 43204, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedret', 'Affiliation': 'Functional Nutrition, Oxidation and Cardiovascular Disease Research Group, Universitat Rovira i Virgili, Hospital Universitari Sant Joan, EURECAT, Reus, 43204, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Motilva', 'Affiliation': ""Food Technology Department, Agrotecnio Center, Escola Tècnica Superior d'Enginyeria Agrària, University of Lleida, Lleida, 25198, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rubió', 'Affiliation': 'Instituto de Ciencias de la Vid y del Vino-ICVV, (CSIC-Consejo Superior de Investigaciones Científicas, Universidad de La Rioja, Gobierno de La Rioja), Finca La Grajera, Ctra. de Burgos Km. 6 (LO-20 - salida 13), Logroño, La Rioja, 26007, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), 08003 Barcelona, Spain. CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Farrás', 'Affiliation': 'Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), 08003 Barcelona, Spain. CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Covas', 'Affiliation': 'Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), 08003 Barcelona, Spain. CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solá', 'Affiliation': 'Functional Nutrition, Oxidation and Cardiovascular Disease Research Group, Universitat Rovira i Virgili, Hospital Universitari Sant Joan, EURECAT, Reus, 43204, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ordovás', 'Affiliation': 'Nutritional Genomics and Epigenomics Group, Instituto Madrileño de Estudios Avanzados (IMDEA) Food Institute, CEI UAM+CSIC, Madrid, 28049, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000049']
1295,32563173,Impact of childhood adversity on network reconfiguration dynamics during working memory in hypogonadal women.,"Many women with no history of cognitive difficulties experience executive dysfunction during menopause. Significant adversity during childhood negatively impacts executive function into adulthood and may be an indicator of women at risk of a mid-life cognitive decline. Previous studies have indicated that alterations in functional network connectivity underlie these negative effects of childhood adversity. There is growing evidence that functional brain networks are not static during executive tasks; instead, such networks reconfigure over time. Optimal dynamics are necessary for efficient executive function; while too little reconfiguration is insufficient for peak performance, too much reconfiguration (supra-optimal reconfiguration) is also maladaptive and associated with poorer performance. Here we examined the impact of adverse childhood experiences (ACEs) on network flexibility, a measure of dynamic reconfiguration, during a letter n-back task within three networks that support executive function: frontoparietal, salience, and default mode networks. Several animal and human subject studies have suggested that childhood adversity exerts lasting effects on executive function via serotonergic mechanisms. Tryptophan depletion (TD) was used to examine whether serotonin function drives ACE effects on network flexibility. We hypothesized that ACE would be associated with higher flexibility (supra-optimal flexibility) and that TD would further increase this measure. Forty women underwent functional imaging at two time points in this double-blind, placebo controlled, crossover study. Participants also completed the Penn Conditional Exclusion Test, a task assessing abstraction and mental flexibility. The effects of ACE and TD were evaluated using generalized estimating equations. ACE was associated with higher flexibility across networks (frontoparietal β = 0.00748, D = 2.79, p = 0.005; salience β = 0.00679, D = 3.02, p = 0.003; and default mode β = 0.00910, D = 3.53, p = 0.0004). While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D = 2.15, p = 0.03; salience β = 0.00393, D = 1.91, p = 0.06; default mode β = 0.00334, D = 1.73, p = 0.08). These results suggest that childhood adversity has lasting impacts on dynamic reconfiguration of functional brain networks supporting executive function and that decreasing serotonin levels may exacerbate these effects.",2020,"While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D =","['Forty women underwent', 'hypogonadal women', 'Many women with no history of cognitive difficulties experience executive dysfunction during menopause']","['ACE', 'Tryptophan depletion (TD', 'functional imaging', 'placebo']","['ACE and TD, active TD increased network flexibility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0587112', 'cui_str': 'During menopause'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",40.0,0.0712399,"While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D =","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Shanmugan', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Penn PROMOTES Research on Sex and Gender in Health, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: sheilashanmugan@gmail.com.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Theodore D', 'Initials': 'TD', 'LastName': 'Satterthwaite', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Penn PROMOTES Research on Sex and Gender in Health, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Ashourvan', 'Affiliation': 'Department of Bioengineering, University of Pennsylvania, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Bassett', 'Affiliation': 'Department of Bioengineering, University of Pennsylvania, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Department of Physics & Astronomy, University of Pennsylvania, Philadelphia, PA, USA; Department of Electrical & Systems Engineering, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kosha', 'Initials': 'K', 'LastName': 'Ruparel', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'C Neill', 'Initials': 'CN', 'LastName': 'Epperson', 'Affiliation': 'Department of Psychiatry, Anschutz Medical Campus, University of Colorado, Aurora, CO USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Loughead', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104710']
1296,32564920,Efficacy and Safety of Intravitreal Sirolimus for Noninfectious Uveitis of the Posterior Segment: Results from the Sirolimus Study Assessing Double-Masked Uveitis Treatment (SAKURA) Program.,"PURPOSE


To evaluate the efficacy and safety of intravitreal sirolimus in the management of noninfectious uveitis of the posterior segment (NIU-PS).
DESIGN


Combined analysis of 2 phase 3, randomized, double-masked, multinational, 6-month studies.
PARTICIPANTS


Adults with active NIU-PS (intermediate uveitis, posterior uveitis, or panuveitis; defined as vitreous haze [VH] ≥1.5+ on modified Standardization of Uveitis Nomenclature scale).
METHODS


Patients were randomized 1:1:1 to receive intravitreal sirolimus 44 μg (n = 208), 440 μg (n = 208), or 880 μg (n = 177) on days 1, 60, and 120. Patients discontinued medications for NIU-PS except for systemic corticosteroids, which were tapered according to protocol. Enrollment in the 880-μg group was terminated after interim results found no significant difference in efficacy compared with the 440-μg dose.
MAIN OUTCOME MEASURES


The primary efficacy end point was the percentage of patients with VH of 0 at month 5 in the study eye without the use of rescue therapy. Secondary efficacy end points included VH of 0 or 0.5+, corticosteroid-tapering success, and changes in best-corrected visual acuity (BCVA). Safety measures included ocular and nonocular adverse events.
RESULTS


A total of 592 patients were randomized. Significantly higher proportions of patients treated with 440 μg compared with 44 μg intravitreal sirolimus achieved VH of 0 (21.2% vs. 13.5%; P = 0.038) and VH of 0 or 0.5+ (50.0% vs. 40.4%; P = 0.049) at month 5. Best-corrected visual acuity was stable (absolute change <5 ETDRS letters) or improved >5 letters in 80.1% and 80.2% of patients in the 440-μg and 44-μg groups, respectively. At month 5, corticosteroids were tapered successfully in 69.6% and 68.8% of patients in the 440-μg and 44-μg groups, and among these patients, VH of 0 or 0.5+ was achieved by 43.5% and 28.1% in the 440-μg and 44-μg groups. Both doses were generally well tolerated. Mean changes from baseline intraocular pressure (IOP) in the study eye at each analysis visit were minimal in all treatment groups.
CONCLUSIONS


Intravitreal sirolimus 440 μg improved ocular inflammation, as measured by VH, compared with the 44-μg dose, with minimal impact on IOP, while preserving BCVA.",2020,"Mean changes from baseline intraocular pressure (IOP) in the study eye at each analysis visit were minimal in all treatment groups.
","['592 patients were randomized', 'Patients', 'Noninfectious Uveitis of the Posterior Segment', 'Adults with active NIU-PS (intermediate uveitis, posterior uveitis, or panuveitis; defined as vitreous haze [VH] ≥1.5+ on modified Standardization of Uveitis Nomenclature scale', '440 μg (n\xa0= 208), or 880 μg (n\xa0= 177) on days 1, 60, and 120']","['Intravitreal Sirolimus', 'intravitreal sirolimus 44 μg ', 'intravitreal sirolimus']","['Efficacy and Safety', 'Mean changes from baseline intraocular pressure (IOP', 'tolerated', 'Best-corrected visual acuity', 'efficacy and safety', 'ocular inflammation', 'efficacy', 'ocular and nonocular adverse events', 'VH of 0 or 0.5+, corticosteroid-tapering success, and changes in best-corrected visual acuity (BCVA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042166', 'cui_str': 'Intermediate uveitis'}, {'cui': 'C0042167', 'cui_str': 'Posterior uveitis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4073113', 'cui_str': 'Vitreous haze'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}, {'cui': 'C0600281', 'cui_str': 'Nomenclature'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",592.0,0.292917,"Mean changes from baseline intraocular pressure (IOP) in the study eye at each analysis visit were minimal in all treatment groups.
","[{'ForeName': 'Pauline T', 'Initials': 'PT', 'LastName': 'Merrill', 'Affiliation': 'Department of Ophthalmology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'W Lloyd', 'Initials': 'WL', 'LastName': 'Clark', 'Affiliation': 'Department of Ophthalmology, Palmetto Retina Center, LLC, West Columbia, South Carolina.'}, {'ForeName': 'Alay S', 'Initials': 'AS', 'LastName': 'Banker', 'Affiliation': ""Banker's Retina Clinic and Laser Center, Navrangpura, Ahmedabad, India.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Fardeau', 'Affiliation': 'Department of Ophthalmology, Pitie-Salpetriere Hospital, Sorbonne University, Paris, France.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Franco', 'Affiliation': 'Organización Médica de Investigación, Buenos Aires, Argentina.'}, {'ForeName': 'Phuc', 'Initials': 'P', 'LastName': 'LeHoang', 'Affiliation': 'Department of Ophthalmology, Pitie-Salpetriere Hospital, Sorbonne University, Paris, France.'}, {'ForeName': 'Shigeaki', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Sivakumar R', 'Initials': 'SR', 'LastName': 'Rathinam', 'Affiliation': 'Department of Uveitis Services, Aravind Eye Hospital, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Ali', 'Affiliation': 'Ribomic USA Inc., Berkeley, California.'}, {'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Mudumba', 'Affiliation': 'Global Biomedical Strategy and Research, Santen, Inc., Emeryville, California.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Shams', 'Affiliation': 'Global Research and Development, Santen, Inc., Emeryville, California.'}, {'ForeName': 'Quan Dong', 'Initials': 'QD', 'LastName': 'Nguyen', 'Affiliation': 'Department of Ophthalmology, Byers Eye Institute, Stanford University, Palo Alto, California. Electronic address: ndquan@stanford.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.033']
1297,32569700,The effects of combination canagliflozin and glucagon-like peptide-1 receptor agonist therapy on intermediate markers of cardiovascular risk in the CANVAS program.,"BACKGROUND


Sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP1-RA) reduce cardiovascular events, and improve intermediate markers of cardiometabolic health, in those with type 2 diabetes. We investigated these effects in the CANVAS Program.
METHODS AND RESULTS


The CANVAS Program comprised 2 double-blind, randomized, placebo-controlled trials (CANVAS and CANVAS-R) done in patients with type 2 diabetes and elevated cardiovascular risk. Effects were estimated using mixed-effects models for continuous measures and Cox regression models for other outcomes. Randomized treatment by subgroup interaction terms were used to compare effects of canagliflozin versus placebo across subgroups defined by baseline use of GLP1-RA. There were 10,142 participants, of whom 407 (4%) were using GLP1-RA therapy at baseline. Those using GLP1-RA at baseline were less likely to have a history of cardiovascular disease (60.4% vs 65.8%), had a longer duration of diabetes (15.2 vs 13.5 years) and a higher body mass index (BMI; 35.6 vs 31.8 kg/m 2 ) but were otherwise similar. There were greater reductions with canagliflozin versus placebo for HbA1c (-0.75% versus -0.58%; P = .0091), SBP (-6.26 versus -3.83 mmHg; P = .0018), and body weight (-3.79 versus -2.18 kg; P < .0001) in those on baseline GLP1-RA therapy. Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74).
CONCLUSIONS


There may be a synergistic effect of SGLT2 inhibition when used on a background of GLP1-RA for intermediate cardiometabolic markers.",2020,"Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74).
","['10,142 participants, of whom 407 (4%) were using GLP1-RA therapy at baseline', 'patients with type 2 diabetes and elevated cardiovascular risk']","['canagliflozin versus placebo', 'placebo-controlled trials (CANVAS and CANVAS-R', 'combination canagliflozin and glucagon-like peptide-1 receptor agonist therapy', 'Sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP1-RA']","['body weight', 'history of cardiovascular disease', 'total serious adverse events', 'major adverse cardiac events', 'longer duration of diabetes', 'SBP', 'eGFR slope']","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",10142.0,0.359796,"Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74).
","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, Sydney, Australia; Sydney Medical School, University of Sydney, Sydney, Australia. Electronic address: carnott@georgeinstitute.org.au.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University of New South Wales, Sydney, Australia; University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gemma A', 'Initials': 'GA', 'LastName': 'Figtree', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Sydney Medical School, University of Sydney, Sydney, Australia; Kolling Institute, Royal North Shore Hospital and University of Sydney, Sydney, Australia.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.""}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Lam', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; National Heart Centre Singapore and Duke-National University, Singapore.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Baim Institute for Clinical Research, Boston, MA, USA.""}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Shaw', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.011']
1298,32553932,The Second Strategic Reperfusion Early After Myocardial Infarction (STREAM-2) study optimizing pharmacoinvasive reperfusion strategy in older ST-elevation myocardial infarction patients.,"BACKGROUND


The STREAM study demonstrated that a pharmaco-invasive strategy was at least as effective as primary PCI (pPCI) in patients presenting early with ST-elevation myocardial infarction (STEMI). The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase. Additionally, a subsequent analysis of full dose tenecteplase or alteplase in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) trials demonstrated a steep increase in bleeding events beginning around the age of 60 years.
METHODS


STREAM-2 will compare the efficacy and safety of a novel pharmaco-invasive strategy as compared to routine pPCI in STEMI patients ≥60 years presenting within 3 hours from symptom onset. In the pharmaco-invasive arm patients will receive half-dose tenecteplase, as soon as possible before transport to a PCI center. In the pPCI arm, patients will be treated according to optimal standard of care defined by local practice. The key criteria for efficacy will be the number of patients achieving ≥50% ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline and the clinical endpoints of death, congestive heart failure, shock or re-infarction, rescue PCI and aborted myocardial infarction, both singularly and as a composite at 30 days. Key safety criteria are total stroke, ICH and major non-intracranial bleeds. Approximately 600 patients will be randomized (400 to pharmaco-invasive treatment and 200 to pPCI). An interim analysis is planned after 300 patients are enrolled to consider adapting the trial to include a larger sample size aimed at undertaking a formal confirmatory trial.
DISCUSSION


The study will provide new insights aimed at establishing an effective and safer pharmaco-invasive treatment for the growing population of older STEMI patients who cannot undergo timely pPCI.",2020,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"['older STEMI patients who cannot undergo timely pPCI', '300 patients', 'older ST-elevation myocardial infarction patients', 'Approximately 600 patients', 'STEMI patients ≥60 years presenting within 3 hours from symptom onset', 'patients presenting early with ST-elevation myocardial infarction (STEMI']",['novel pharmaco-invasive strategy'],"['intracranial hemorrhage (ICH', 'bleeding events', 'efficacy and safety']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",600.0,0.0767294,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Welsh', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Goldstein', 'Affiliation': 'Emergency Department and SAMU, Lille University Hospital, Lille, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Pages', 'Affiliation': 'Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Danays', 'Affiliation': 'TDC, Aix en Provence, France.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Van de Werf', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. Electronic address: frans.vandewerf@kuleuven.be.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.029']
1299,32570700,Acute Effects of a Whole Body Vibration Session on the Vibration Perception Threshold in Patients with Type 2 Diabetes Mellitus.,"BACKGROUND


Type 2 Diabetes Mellitus (T2DM) is a chronic disease that affects millions of people, and according to the International Diabetes Federation, 46.5% of people have undiagnosed diabetes. One of the most common complications of diabetes mellitus is loss of peripheral sensation. Whole Body Vibration (WBV) is a therapy, and it would be interesting to know if it can be considered as a training method to improve the Vibration Perception Threshold (VPT). The aim of the study is to verify whether there are really acute effects on the VPT after a WBV training session in people with T2DM.
METHODS


Ninety people with T2DM (56 men and 34 women) were randomly allocated to two groups: the WBV group and the placebo group. The ninety subjects went through a VPT training test before receiving the assigned intervention, and they performed the VPT test using the Vibratron II device.
RESULTS


After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group.
CONCLUSIONS


Vibration perception threshold is increased after a WBV training session in people with T2DM, compared to a placebo group.",2020,"After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group.
","['ninety subjects went through a VPT training test before receiving the assigned intervention, and they performed the VPT test using the Vibratron II device', 'Patients with Type 2 Diabetes Mellitus', 'people with T2DM', 'Ninety people with T2DM (56 men and 34 women']","['Whole Body Vibration Session', 'placebo', 'Whole Body Vibration (WBV']","['VPT', 'Vibration Perception Threshold']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",90.0,0.0272834,"After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group.
","[{'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Dominguez-Muñoz', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Hernandez-Mocholi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Villafaina', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'García-Gordillo', 'Affiliation': 'Facultad de Administración y Negocios, Universidad Autónoma de Chile, sede Talca 3467987, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collado-Mateo', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, 28943 Madrid, Spain.'}, {'ForeName': 'Narcis', 'Initials': 'N', 'LastName': 'Gusi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Jose Carmelo', 'Initials': 'JC', 'LastName': 'Adsuar', 'Affiliation': 'Health Economy Motricity and Education (HEME), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124356']
1300,32442688,"A commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - An open labeled, randomized controlled trial"" - What is missing for a careful analysis? The importance of considering all the factors involved.",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.102212,,"[{'ForeName': 'Leandro Ryuchi', 'Initials': 'LR', 'LastName': 'Iuamoto', 'Affiliation': 'Department of Surgery, Laboratory of Medical Research 02, Division of Human Structural Topography, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'General and Gastrointestinal (GI) Surgeon, Hospital Das Clínicas, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil. Electronic address: alberto.meyer@usp.br.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.045']
1301,32574716,Stevens-Johnson Syndrome Secondary to Doxycycline Treatment in a Teenage Boy.,,2020,,[],['Doxycycline'],[],[],"[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}]",[],,0.0152077,,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Morgado-Carrasco', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'González Enseñat', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Prat', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vicente-Villa', 'Affiliation': 'Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España. Electronic address: avicente@sjdhospitalbarcelona.org.'}]",Actas dermo-sifiliograficas,['10.1016/j.ad.2019.02.021']
1302,32443977,"The evaluation of Suchana, a large-scale development program to prevent chronic undernutrition in north-eastern Bangladesh.","Evidence of the impact of community-based nutrition programs is uncommon for two main reasons: the lack of untreated controls, and implementation does not account for the evaluation design. Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households. Suchana is being implemented in 157 unions, the smallest administrative unit of government, in two districts of Sylhet. Suchana will deliver a package of interventions to poor people in about 40 randomly selected new unions annually over 4 years, until all are covered. All beneficiaries will receive the normal government nutrition services. For evaluation purposes the last 40 unions will act as a control for the first 40 intervention unions. The remaining unions will receive the program but will not take part in the evaluation. A baseline survey was conducted in both intervention and control unions; it will be repeated after 3 years to estimate the impact on the prevalence of stunted children and other indicators. This stepped wedge design has several advantages for both the implementation and evaluation of services, as well as some disadvantages. The units of delivery are randomized, which controls for other influences on outcomes; the program supports government service delivery systems, so it is replicable and scalable; and the program can be improved over time as lessons are learned. The main disadvantages are the difficulty of estimating the impact of each component of the program, and the geographical distribution of unions, which increases program delivery costs. Stepped implementation allows a cluster randomized trial to be achieved within a large-scale poverty alleviation program and phased-in and scaled-up over a period of time. This paper may encourage evaluators to consider how to estimate attributable impact by using stepped implementation, which allows the counterfactual group eventually to be treated.",2020,"Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households.","['chronic undernutrition in north-eastern Bangladesh', '157 unions, the smallest administrative unit of government, in two districts of Sylhet']",['community-based nutrition programs'],[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0018104', 'cui_str': 'Government'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0221132,"Suchana is a large-scale program to prevent malnutrition in children in Sylhet division, Bangladesh by improving the livelihoods and nutrition knowledge of poor and very poor households.","[{'ForeName': 'Nuzhat', 'Initials': 'N', 'LastName': 'Choudhury', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh. nuzhat@icddrb.org.'}, {'ForeName': 'Mohammad Jyoti', 'Initials': 'MJ', 'LastName': 'Raihan', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh.'}, {'ForeName': 'S M Tanvir', 'Initials': 'SMT', 'LastName': 'Ahmed', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Kazi Eliza', 'Initials': 'KE', 'LastName': 'Islam', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Self', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Shahed', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Save the Children Bangladesh, House CWN (A) 35, Road 43, Gulshan, Dhaka, Bangladesh.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Schofield', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': ""Save the Children U.K., 1 St John's Lane, London, EC1M 4AR, UK.""}, {'ForeName': 'Tahmeed', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Nutrition and Clinical Services Division, icddrb, 68 Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka, 1212, Bangladesh.'}]",BMC public health,['10.1186/s12889-020-08769-4']
1303,32574761,HAWK and HARRIER: Ninety-Six-Week Outcomes from the Phase 3 Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration.,"PURPOSE


To report the 96-week outcomes from HAWK and HARRIER.
DESIGN


Phase 3, prospective, randomized, double-masked, multicenter studies comparing efficacy and safety of brolucizumab 3 mg (HAWK only) and 6 mg with aflibercept 2 mg in eyes with neovascular age-related macular degeneration (nAMD).
PARTICIPANTS


Treatment-naïve eyes with nAMD were randomized 1:1:1 to brolucizumab 3 mg (n = 358), brolucizumab 6 mg (n = 360), aflibercept 2 mg (n = 360; HAWK) or 1:1 to brolucizumab 6 mg (n = 370), aflibercept 2 mg (n = 369; HARRIER).
METHODS


After 3 monthly loading doses, brolucizumab patients received every (q)-12-week (w) dosing, possibly adjusting to q8w dosing if disease activity was present at predefined disease activity assessment (DAA) visits. Aflibercept was dosed in a fixed q8w regimen. Visual and anatomic parameters were assessed throughout. Primary end point was at week 48 (48w), confirmed at 96w.
MAIN OUTCOME MEASURES


Mean best-corrected visual acuity (BCVA) change from baseline, proportion of patients on an q12w regimen, retinal thickness, retinal fluid changes, and safety, all to 96w.
RESULTS


Mean change (least squares [LS] mean ± standard error) in BCVA from baseline to 96w in HAWK was 5.6±0.79 Early Treatment Diabetic Retinopathy Study (ETDRS) letters for brolucizumab 3 mg, 5.90±0.78 letters for brolucizumab 6 mg, and 5.3±0.78 letters for aflibercept and in HARRIER was 6.1±0.73 letters for brolucizumab 6 mg and 6.6 ± 0.73 letters for aflibercept. Greater central subfield thickness reductions were observed with brolucizumab 6 mg versus aflibercept in HAWK (LS mean, -174.8 μm vs. -148.7 μm; 95% confidence interval for treatment difference, -46.2 to -5.9 μm; P = 0.0115) and HARRIER (LS mean, -197.7 μm vs. -155.1 μm; 95% confidence interval for treatment difference, -62.0 to -23.3 μm; P < 0.0001). The proportions of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF) at 96w in HAWK were 31% (P = 0.0688) and 24% (P = 0.0002) for brolucizumab 3 mg and 6 mg and 37% for aflibercept, whereas in HARRIER, they were 24% for brolucizumab 6 mg (P < 0.0001) and 39% for aflibercept. At 92w (last DAA), a 45.4% and 38.6% probability was observed for brolucizumab 6 mg patients of maintaining an q12w treatment regimen in HAWK and HARRIER, respectively. Brolucizumab exhibited an overall well-tolerated safety profile.
CONCLUSIONS


Visual outcomes from 48w to 96w confirm the efficacy achieved at 48w. Brolucizumab demonstrated greater fluid resolution compared with aflibercept. The q12w potential for brolucizumab observed at 48w was maintained to 96w.",2020,"Greater central subfield thickness (CST) reductions were observed with brolucizumab 6mg vs aflibercept in HAWK (LS mean; -174.8 vs -148.7 μm; 95% CI for treatment difference -46.2, -5.9; p=0.0115) and HARRIER (LS mean; -197.7 vs -155.1 μm; 95% CI for treatment difference, -62.0, -23.3; p<0.0001).","['neovascular age-related macular degeneration', 'eyes with neovascular AMD (nAMD) PARTICIPANTS: Treatment naive eyes with nAMD']","['brolucizumab 3mg', 'aflibercept', 'Aflibercept', 'brolucizumab', 'brolucizumab 6mg (n=370) or aflibercept 2mg (n=369) [HARRIER', 'HAWK and HARRIER', 'Brolucizumab', 'brolucizumab 6mg (n=360) or aflibercept 2mg (n=360) [HAWK']","['Visual and anatomical parameters', 'proportion of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF', 'Mean change (LS mean ±SE) in BCVA (ETDRS letters', 'efficacy and safety', 'overall well-tolerated safety profile', 'Greater central subfield thickness (CST) reductions', 'Mean best corrected visual acuity (BCVA) change from baseline, proportion of patients on q12w, retinal thickness, retinal fluid changes, and safety', 'fluid resolution']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4550124', 'cui_str': 'brolucizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0324380', 'cui_str': 'Harrier dog'}, {'cui': 'C0325553', 'cui_str': 'Hawk'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0063613', 'cui_str': 'insulin resistance factor (uremia)'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]",,0.0754469,"Greater central subfield thickness (CST) reductions were observed with brolucizumab 6mg vs aflibercept in HAWK (LS mean; -174.8 vs -148.7 μm; 95% CI for treatment difference -46.2, -5.9; p=0.0115) and HARRIER (LS mean; -197.7 vs -155.1 μm; 95% CI for treatment difference, -62.0, -23.3; p<0.0001).","[{'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona. Electronic address: pdugel@gmail.com.'}, {'ForeName': 'Rishi P', 'Initials': 'RP', 'LastName': 'Singh', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Koh', 'Affiliation': 'Eye & Retina Surgeons, Singapore, Republic of Singapore.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ogura', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Weissgerber', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Kinfemichael', 'Initials': 'K', 'LastName': 'Gedif', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Duke Eye Center, Durham, North Carolina.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tadayoni', 'Affiliation': 'Lariboisiere & Saint Louis Hospitals, Universite de Paris, Paris, France.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schmidt-Erfurth', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'University of Bonn, Bonn, Germany.'}]",Ophthalmology,['10.1016/j.ophtha.2020.06.028']
1304,32574773,Macular and Peripapillary Optical Coherence Tomography Angiography Metrics Predict Progression in Diabetic Retinopathy: A Sub-analysis of TIME-2b Study Data.,"PURPOSE


To identify optical coherence tomography angiography (OCTA)-derived vessel metrics of the macula and optic nerve head (ONH) that predict diabetic retinopathy (DR) disease progression.
DESIGN


Secondary analysis of clinical trial data.
METHODS


This was a sub-analysis of prospectively collected data from 73 subjects that participated in the TIME-2b study (Aerpio Pharmaceuticals), a multicenter clinical trial for patients with moderate-to-severe DR treated with AKB-9778 and followed over a 12-month period. Eligible subjects were tested every 3 months with color fundus photography, spectral-domain OCT, and slit-lamp biomicroscopy. OCTA of the macula and ONH was obtained for a subset of patients enrolled at participating sites. En face, full-depth retinal projections centered at the macula were analyzed for multiple metrics including foveal avascular zone (FAZ) area and perimeter, nonperfusion area, vessel density (VD), and presence of intraretinal microvascular abnormalities (IRMA). VD of the radial peripapillary capillaries was evaluated in 4 quadrants surrounding the optic disc for ONH images. Progression was defined as a ≥2-step increase in DR severity scale score or development of diabetic macular edema.
RESULTS


Over a follow-up period of 12 months, 15 of 73 (20.5%) subjects progressed. At pretreatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
CONCLUSIONS


FAZ area and temporal peripapillary VD are predictors of DR progression. OCTA metrics may improve progression risk assessment in DR when compared to established risk factors alone.",2020,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
","['Diabetic Retinopathy', '73 subjects that participated in the TIME-2b Study (Aerpio Pharmaceuticals), a multi-center clinical trial for patients with moderate to severe DR treated with AKB-9778 and followed over a 12-month period']","['color fundus photography, spectral domain OCT and slit-lamp biomicroscopy', 'optical coherence tomography angiography (OCTA']","['larger FAZ area, presence of IRMA, and reduced peripapillary VD', 'DR severity scale score or development of diabetic macular edema', 'foveal avascular zone (FAZ) area and perimeter, non-perfusion area, vessel density (VD) and presence of intraretinal microvascular abnormalities (IRMA']","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4043862', 'cui_str': 'AKB-9778'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3714733', 'cui_str': 'Intraretinal microvascular abnormality'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0442163', 'cui_str': 'Peripapillary'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",73.0,0.0248145,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
","[{'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Custo Greig', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA; Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Brigell', 'Affiliation': 'Aerpio Pharmaceuticals, Cincinnati, Ohio, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Levine', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA; Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': 'Aerpio Pharmaceuticals, Cincinnati, Ohio, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Moult', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Fujimoto', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Nadia K', 'Initials': 'NK', 'LastName': 'Waheed', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA. Electronic address: nadiakwaheed@gmail.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.009']
1305,32445850,Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Intraarticular Injection of the Shoulder: A Randomized Double-Blind Controlled Trial.,"OBJECTIVE


This study was performed to compare the effects of a vapocoolant spray and a eutectic mixture of local anesthetics (EMLA) cream on reducing pain during intra-articular (IA) injection of the shoulder.
DESIGN


Double-blind randomized placebo-controlled clinical trial.
SETTING


University hospital.
PARTICIPANTS


Patients (N=63) who underwent IA injection of the shoulder joint were randomized into the spray group, EMLA group, or placebo group.
INTERVENTION


Placebo cream+vapocoolant spray (spray group), EMLA cream+placebo spray (EMLA group), or placebo cream+placebo spray (placebo group) before IA injection.
MAIN OUTCOME MEASURES


A 100-mm visual analog scale (VAS) for injection pain and 5-point Likert scales for participant satisfaction and preference for repeated use were administered immediately after IA injection.
RESULTS


The VAS scores for pain during IA injection were 30.0 (95% CI, 19.7-41.2) in the spray group, 50.0 (95% CI, 37.7-63.0) in the EMLA group, and 53.8 (95% CI, 41.6-65.0) in the placebo group (F=6.403, P<.01). The spray group showed significantly better Likert scale scores than the placebo group for participant satisfaction (P=.003) and preference for repeated use (P<.001).
CONCLUSIONS


Vapocoolant spray was effective in reducing pain during IA injection of the shoulder.",2020,"The spray group showed significantly better Likert scale scores than the placebo group for participant satisfaction (P = 0.003) and preference for repeated use (P < 0.001).
","['Sixty-three patients who underwent IA injection of the shoulder joint', 'Pain during Intraarticular Injection of the Shoulder', 'University hospital']","['EMLA', 'vapocoolant spray and an eutectic mixture of local anesthetics (EMLA) cream', 'Placebo cream + vapocoolant spray (spray group), EMLA cream + placebo spray (EMLA group), or placebo cream + placebo spray (placebo', 'Vapocoolant spray', 'Vapocoolant Spray and Topical Anesthetic Cream', 'placebo']","['pain during intraarticular (IA) injection', '100-mm visual analog scale (VAS) for injection pain and 5-point Likert scales for participant satisfaction and preference for repeated use', 'pain', 'VAS scores for pain', 'Likert scale scores']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",63.0,0.716197,"The spray group showed significantly better Likert scale scores than the placebo group for participant satisfaction (P = 0.003) and preference for repeated use (P < 0.001).
","[{'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Moon', 'Affiliation': ""Department of Anesthesiology and Pain Medicine (Moon), Catholic University Seoul St. Mary's Hospital, Seoul, Korea.""}, {'ForeName': 'Sang-Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon, Korea. Electronic address: sanghyunkim71@gmail.com.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Seok', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon, Korea.'}, {'ForeName': 'Seung Yeol', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon, Korea.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.04.021']
1306,32444517,Cluster Randomized Trial Evaluating Impact of a Community-based Microfinance Scheme on Childhood Nutritional Status: Evidence-based Medicine Viewpoint.,,2020,,[],['Community-based Microfinance Scheme'],[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0435444,,"[{'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Mathew', 'Affiliation': 'Department of Pediatrics, PGIMER, Chandigarh, India. dr.joseph.l.mathew@gmail.com.'}]",Indian pediatrics,[]
1307,32444518,Cluster Randomized Trial Evaluating Impact of a Community-based Microfinance Scheme on Childhood Nutritional Status: Pediatrician's Viewpoint.,,2020,,[],['Community-based Microfinance Scheme'],[],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0246971,,"[{'ForeName': 'Manoja Kumar', 'Initials': 'MK', 'LastName': 'Das', 'Affiliation': 'The INCLEN Trust International, New Delhi, India. manoj@inclentrust.org.'}]",Indian pediatrics,[]
1308,32444519,Cluster Randomized Trial Evaluating Impact of a Community-based Microfinance Scheme on Childhood Nutritional Status: Nutritionist's Viewpoint.,,2020,,['Childhood Nutritional Status'],['Community-based Microfinance Scheme'],[],"[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0243304,,"[{'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar', 'Affiliation': 'Department of Pediatrics, LHMC and KSCH, New Delhi, India. pkpaed@gmail.com.'}]",Indian pediatrics,[]
1309,32320482,Using Healthcare Databases to Replicate Trial Findings for Supplemental Indications: Adalimumab in Patients with Ulcerative Colitis.,"Regulators wish to understand whether real world evidence can be used for secondary indications of biologics. Using the secondary indication of adalimumab for ulcerative colitis (UC) as an example, we aimed to replicate the ULTRA-2 randomized controlled trial finding on the effectiveness of adalimumab in patients with UC using realworld data analyses. Adalimumab, a TNF-alpha receptor inhibitor initially approved for Crohn's disease, was approved for moderate to severe UC in 2012. The ULTRA-2 trial had shown improved remission against placebo in patients with UC. Using claims data (2006-2012), we conducted a cohort study of patients with UC who initiated adalimumab and compared them with (i) nonusers and (ii) new users of infliximab using propensity score matching. The coprimary end points were corticosteroid (CS) discontinuation within 8 weeks and 1 year of treatment. We computed hazard ratios (HRs) and 95% confidence intervals (CIs). We identified 398 matched pairs of adalimumab users vs. nonusers and 326 pairs of adalimumab vs. infliximab users. Adalimumab users were 28% more likely to achieve CS-discontinuation compared with nonusers over 1 year (HR = 1.28; 95% CI 0.94-1.73). However, unlike in ULTRA-2, this effect was not observed in the first 8 weeks (HR = 0.79; 95% CI 0.65-0.97). Compared with infliximab, adalimumab initiators showed no incremental benefit over 1 year (HR = 1.08; 95% CI 0.80-1.04), but showed a 22% reduction (HR = 0.78; 95% CI 0.64-0.95) during the first 8 weeks of treatment. In summary, our results highlight opportunities and some limitations of database analysis to identify treatment effects for secondary indications.",2020,"Compared with infliximab, adalimumab initiators showed no incremental benefit over 1 year (HR = 1.08; 95% CI 0.80-1.04), but showed a 22% reduction (HR = 0.78; 95% CI 0.64-0.95) during the first 8 weeks of treatment.","['398 matched pairs of adalimumab users vs. nonusers and 326 pairs of adalimumab vs. infliximab users', 'patients with UC who initiated adalimumab and compared them with (i) nonusers and (ii) new users of', 'ulcerative colitis (UC', 'patients with UC using realworld data analyses', 'Patients with Ulcerative Colitis', 'patients with UC']","['adalimumab', 'Adalimumab', 'infliximab', 'infliximab, adalimumab', 'placebo']","['CS-discontinuation', 'corticosteroid (CS) discontinuation']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",,0.17633,"Compared with infliximab, adalimumab initiators showed no incremental benefit over 1 year (HR = 1.08; 95% CI 0.80-1.04), but showed a 22% reduction (HR = 0.78; 95% CI 0.64-0.95) during the first 8 weeks of treatment.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Spoendlin', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Rishi J', 'Initials': 'RJ', 'LastName': 'Desai', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Franklin', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Payne', 'Affiliation': 'Aetion Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schneeweiss', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1861']
1310,32445609,Dependency of respiratory system mechanics on positive end-expiratory pressure and recruitment maneuvers in lung healthy pediatric patients-A randomized crossover study.,"BACKGROUND


The lungs of pediatric patients are subjected to tidal derecruitment during mechanical ventilation and in contrast to adult patients this unfavorable condition cannot be resolved with small c increases. This raises the question if higher end-expiratory pressure increases or recruitment maneuvers may resolve tidal derecruitment in pediatric patients.
AIMS


We hypothesized that higher PEEP resolves tidal derecruitment in pediatric patients and that recruitment maneuvers between the pressure changes support the improvement of respiratory system mechanics.
METHODS


The effects of end-expiratory pressure changes from 3 to 7 cmH 2  O and vice versa without and with intermediate recruitment maneuvers on respiratory system mechanics and regional ventilation were investigated in 57 mechanically ventilated pediatric patients. The intratidal respiratory system compliance was determined from volume and pressure data before and after PEEP changes and categorized to indicate tidal derecruitment.
RESULTS


Tidal derecruitment occurred comparably frequently at PEEP 3 cmH 2  O without (13 out of 14 cases) and with recruitment maneuver (14 out of 14 cases) and at PEEP 7 cmH 2  O without (13 out of 14 cases) and with recruitment maneuver (13 out of 15 cases).
CONCLUSIONS


We conclude that contrary to our hypothesis, PEEP up to 7 cmH 2  O is not sufficient to resolve tidal derecruitment and that recruitment maneuvers may be dispensable in mechanically ventilated pediatric patients.",2020,The effects of end-expiratory pressure changes from 3 to 7 cm H 2  O and vice versa without and with intermediate recruitment maneuvers on respiratory system mechanics and regional ventilation were investigated in 57 mechanically ventilated pediatric patients.,"['mechanically ventilated pediatric patients', 'lung healthy pediatric patients', 'pediatric patients', '57 mechanically ventilated pediatric patients']",['end-expiratory pressure changes from 3 to 7 cm\xa0H 2  O and vice versa without and with intermediate recruitment maneuvers'],"['respiratory system mechanics and regional ventilation', 'Tidal derecruitment']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0428720', 'cui_str': 'End-expiratory pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",57.0,0.0716177,The effects of end-expiratory pressure changes from 3 to 7 cm H 2  O and vice versa without and with intermediate recruitment maneuvers on respiratory system mechanics and regional ventilation were investigated in 57 mechanically ventilated pediatric patients.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schumann', 'Affiliation': 'Department of Anesthesiology and Critical Care, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Feth', 'Affiliation': 'Department of Anesthesiology and Critical Care, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Borgmann', 'Affiliation': 'Department of Anesthesiology and Critical Care, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Wirth', 'Affiliation': 'Department of Anesthesiology and Critical Care, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}]",Paediatric anaesthesia,['10.1111/pan.13927']
1311,32446951,Dexamethasone for the Prevention of a Pain Flare After Palliative Radiation Therapy for Painful Bone Metastases: The Multicenter Double-Blind Placebo-Controlled 3-Armed Randomized Dutch DEXA Study.,"PURPOSE


After radiation therapy for painful bone metastases, up to 44% of patients report a pain flare (PF). Our study compared 2 dose schedules of dexamethasone versus placebo to prevent PF.
METHODS AND MATERIALS


This double-blind, randomized, placebo-controlled trial allocated patients with painful bone metastases from solid tumors randomly to receive 8 mg dexamethasone before radiation therapy followed by 3 daily doses (group A), 8 mg dexamethasone followed by 3 doses of placebo (group B), or 4 doses of placebo (group C). Patients reported worst pain scores, study medication side effects, and opioid intake before treatment and thereafter daily for 14 days and on day 28. PF was defined as at least a 2-point increase on a 0 to 10 pain scale with no decrease in opioid intake or a 25% or greater increase in opioid intake with no decrease in pain score, followed by a return to baseline or lower. The primary analysis was by intention to treat with patients who had missing data classified as having a PF.
RESULTS


From January 2012 to April 2016, 295 patients were randomized. PF incidence was 38% for group A, 27% for group B, and 39% for group C (P = .07). Although patients in group B had the lowest PF incidence, a relatively high percentage did not return to baseline pain levels, indicating pain progression. The mean duration of PF was 2.1 days for group A, 4.5 days for group B, and 3.3 days for group C (P = .0567). Dexamethasone postponed PF occurrence; in group A 52% occurred on days 2 to 5 versus 73% in group B and 99% in group C (P = .02). Patients in group A reported lower mean pain scores on days 2 to 5 than those in group B or C (P < .001). Side effects were similar.
CONCLUSIONS


There was insufficient evidence that dexamethasone reduced the incidence of radiation-induced PF. However, dexamethasone postponed the occurrence of PF and led to lower mean pain scores on days 2 to 5.",2020,Patients in group A reported lower mean pain scores on days 2-5 than in B or C (p<0.001).,"['patients with painful bone metastases from solid tumors randomly to receive A: 8 mg', 'painful bone metastases', 'From January 2012 to April 2016, 295 patients were randomized', 'painful bone metastases up to 44% of patients report a pain flare (PF']","['radiotherapy', 'dexamethasone', 'dexamethasone before radiotherapy', 'Dexamethasone', 'palliative radiotherapy', 'placebo']","['mean duration of PF', 'PF incidence', 'incidence of radiation-induced PF', 'Side effects', 'mean pain scores', 'opioid intake', 'PF', 'pain score', 'worst pain scores, study medication side effects and opioid intake', 'PF occurrence', 'lowest PF-incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",295.0,0.596742,Patients in group A reported lower mean pain scores on days 2-5 than in B or C (p<0.001).,"[{'ForeName': 'Yvette M', 'Initials': 'YM', 'LastName': 'van der Linden', 'Affiliation': 'Department of Radiotherapy, Leiden University Medical Centre, Leiden, the Netherlands; Centre of Expertise in Palliative Care, Leiden University Medical Centre, Leiden, the Netherlands. Electronic address: ymvanderlinden@lumc.nl.'}, {'ForeName': 'Paulien G', 'Initials': 'PG', 'LastName': 'Westhoff', 'Affiliation': 'Department of Radiotherapy, University Medical Centre Utrecht, Utrecht, the Netherlands; Department of Radiotherapy, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Stellato', 'Affiliation': 'Department of Biostatistics, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'van Baardwijk', 'Affiliation': 'MAASTRO, Maastricht, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'de Vries', 'Affiliation': 'Department of Radiotherapy, National Cancer Institute, Amsterdam, the Netherlands; Department of Radiotherapy, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiotherapy, Medical Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Wiggenraad', 'Affiliation': 'Department of Radiotherapy, Haaglanden Medical Centre, The Hague, the Netherlands.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Bakri', 'Affiliation': 'Department of Radiotherapy, Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'Gerda', 'Initials': 'G', 'LastName': 'Wester', 'Affiliation': 'Radiotherapy Group Arnhem, Arnhem, the Netherlands.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'de Pree', 'Affiliation': 'Department of Radiotherapy, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Lieneke', 'Initials': 'L', 'LastName': 'van Veelen', 'Affiliation': 'ZRTI, Vlissingen, the Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Budiharto', 'Affiliation': 'Department of Radiotherapy, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Schippers', 'Affiliation': 'Bernard Verbeeten Institute, Tilburg, the Netherlands.'}, {'ForeName': 'Anna K L', 'Initials': 'AKL', 'LastName': 'Reyners', 'Affiliation': 'Department of Medical Oncology, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'de Graeff', 'Affiliation': 'Department of Medical Oncology, University Medical Centre Utrecht, Utrecht, the Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.05.007']
1312,32453223,The Intelligent Automated Pressure-Adjustable Orthosis for Patients With Adolescent Idiopathic Scoliosis: A Bi-Center Randomized Controlled Trial.,"STUDY DESIGN


Randomized controlled trial.
OBJECTIVE


To compare the effectiveness of the automated pressure-adjustable orthosis (PO) and conventional orthosis (CO) for treatment of adolescent idiopathic scoliosis (AIS).
SUMMARY OF BACKGROUND DATA


Orthosis wearing quality may influence its effectiveness for AIS. An automated PO aimed to provide a more optimized and consistent biomechanical environment. Clinical evaluation was conducted to study the effectiveness of this innovative orthosis.
METHODS


Patients with AIS who met the criteria (Age 10-14, Cobb 20°-40°, and Risser sign 0-2) were recruited from two clinics and randomly assigned to the PO and CO groups. Compliance sensors were embedded in both groups, while the PO group was set to adjust the interfacial pressure as prescribed automatically. Clinical assessments (radiology and quality of life, QoL) were conducted at the baseline, immediate after orthosis fitting and 1-year follow-up. Orthosis wearing compliance was tracked using thermo and pressure sensors.
RESULTS


Twenty-four patients were enrolled with one drop-out (PO, n = 11; CO, n = 12). Significant immediate in-orthosis correction was observed in the PO (11.0° ± 6.5°, 42.0%, P < 0.001) and CO (10.3° ± 5.3°, 37.6%, P < 0.001) groups. After 1 year, no patient with PO progressed while two with CO had progression more than 5°. The mean daily wearing duration was 1.1 hours longer in the PO group as compared with the CO group (15.4 ± 4.5 vs. 14.3 ± 3.8 h). Moreover, the wearing quality within the targeted pressure was 33.9% higher in the PO group (56.5 ± 16.5% vs. 23.1 ± 12.1%, P < 0.001). No significant difference in the QoL results was observed between two groups nor within both groups during the study period.
CONCLUSION


This study showed that the automated PO could enhance wearing quality when compared with the CO, thus offering a better biomechanical corrective effect in the study period without adverse effect on the patients' wearing quantity and QoL.
LEVEL OF EVIDENCE


1.",2020,"No significant difference in the QoL results was observed between two groups nor within both groups during the study period.
","['Patients with Adolescent Idiopathic Scoliosis (AIS', 'Patients with AIS who met the criteria (Age 10-14, Cobb 20', 'Twenty-four patients were enrolled with one drop-out (PO, n\u200a=\u200a11; CO, n\u200a=\u200a12', 'adolescent idiopathic scoliosis (AIS']","['automated pressure-adjustable orthosis (PO) and conventional orthosis (CO', 'CO']","['QoL results', 'wearing quality', 'orthosis correction', 'mean daily wearing duration', 'CO', 'Clinical assessments (radiology and quality of life, QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}]",24.0,0.078417,"No significant difference in the QoL results was observed between two groups nor within both groups during the study period.
","[{'ForeName': 'Yangmin', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Biomedical Engineering, The Hong Kong Polytechnic University, Hong Kong, PRC.'}, {'ForeName': 'Edmond', 'Initials': 'E', 'LastName': 'Lou', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Alberta, Alberta, Canada.'}, {'ForeName': 'Tsz Ping', 'Initials': 'TP', 'LastName': 'Lam', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, PRC.'}, {'ForeName': 'Jack Chun-Yiu', 'Initials': 'JC', 'LastName': 'Cheng', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, PRC.'}, {'ForeName': 'Sai Wing', 'Initials': 'SW', 'LastName': 'Sin', 'Affiliation': 'Department of Prosthetics and Orthotics, Prince of Wales Hospital, Hong Kong, PRC.'}, {'ForeName': 'Wing Kwan', 'Initials': 'WK', 'LastName': 'Kwok', 'Affiliation': 'Department of Prosthetics and Orthotics, Prince of Wales Hospital, Hong Kong, PRC.'}, {'ForeName': 'Man Sang', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'Department of Biomedical Engineering, The Hong Kong Polytechnic University, Hong Kong, PRC.'}]",Spine,['10.1097/BRS.0000000000003559']
1313,32450063,Comparison of Removable Rigid Dressing and Elastic Bandage for Residual Limb Maturation in Transtibial Amputees: A Randomized Controlled Trial.,"OBJECTIVE


To determine the effect of a removable rigid dressing (RRD) on the time to residual limb maturation compared with elastic bandage (EB) in transtibial amputees.
DESIGN


Experimental single-blinded (assessor-blinded) randomized controlled trial.
SETTING


Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital.
PARTICIPANTS


Transtibial amputees (N=25) with immature residual limb.
INTERVENTION


Participants were allocated to use RRD or EB to achieve residual limb maturation, and all participants in both groups were trained with the same preprosthetic program.
MAIN OUTCOME MEASURES


The time to residual limb maturation, patient satisfaction, and complications were compared between the 2 groups.
RESULTS


Median time to residual limb maturation was significantly lower in the RRD group (median, 28d [interquartile range, 17-51d]) than in the EB group (median, 54d [interquartile range, 30-77d]; P=.020). After accounting for time since amputation, maturation time remained significantly lower in the RRD group (adjusted hazard ratio, 3.32; 95% CI, 1.08-10.20; P=.036). There was no significant difference in complications or patient satisfaction.
CONCLUSION


In postoperative management of transtibial amputation, the use of RRD had a significantly shorter period to residual limb maturation when compared with the EB group.",2020,"There was no significant difference in complications or patient satisfaction.
","['Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital', 'Twenty-five transtibial amputees with immature residual limb', 'transtibial amputees']","['removable rigid dressing (RRD', 'elastic bandage (EB', 'removable rigid dressing and elastic bandage', 'RRD or EB']","['residual limb maturation', 'time to residual limb maturation, patient satisfaction and complications', 'time since amputation, maturation time', 'complications or patient satisfaction', 'Median time to residual limb maturation']","[{'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.126639,"There was no significant difference in complications or patient satisfaction.
","[{'ForeName': 'Nantawan', 'Initials': 'N', 'LastName': 'Koonalinthip', 'Affiliation': 'Department of Rehabilitation Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand; Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: col_kate@hotmail.com.'}, {'ForeName': 'Aungsumalin', 'Initials': 'A', 'LastName': 'Sukthongsa', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Siriporn', 'Initials': 'S', 'LastName': 'Janchai', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.009']
1314,32579812,Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts.,"BACKGROUND


The effects on patient safety of eliminating extended-duration work shifts for resident physicians remain controversial.
METHODS


We conducted a multicenter, cluster-randomized, crossover trial comparing two schedules for pediatric resident physicians during their intensive care unit (ICU) rotations: extended-duration work schedules that included shifts of 24 hours or more (control schedules) and schedules that eliminated extended shifts and cycled resident physicians through day and night shifts of 16 hours or less (intervention schedules). The primary outcome was serious medical errors made by resident physicians, assessed by intensive surveillance, including direct observation and chart review.
RESULTS


The characteristics of ICU patients during the two work schedules were similar, but resident physician workload, described as the mean (±SD) number of ICU patients per resident physician, was higher during the intervention schedules than during the control schedules (8.8±2.8 vs. 6.7±2.2). Resident physicians made more serious errors during the intervention schedules than during the control schedules (97.1 vs. 79.0 per 1000 patient-days; relative risk, 1.53; 95% confidence interval [CI], 1.37 to 1.72; P<0.001). The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71). There was wide variability among sites, however; errors were lower during intervention schedules than during control schedules at one site, rates were similar during the two schedules at two sites, and rates were higher during intervention schedules than during control schedules at three sites. In a secondary analysis that was adjusted for the number of patients per resident physician as a potential confounder, intervention schedules were no longer associated with an increase in errors.
CONCLUSIONS


Contrary to our hypothesis, resident physicians who were randomly assigned to schedules that eliminated extended shifts made more serious errors than resident physicians assigned to schedules with extended shifts, although the effect varied by site. The number of ICU patients cared for by each resident physician was higher during schedules that eliminated extended shifts. (Funded by the National Heart, Lung, and Blood Institute; ROSTERS ClinicalTrials.gov number, NCT02134847.).",2020,"The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71).",['pediatric resident physicians during their intensive care unit (ICU) rotations'],[],"['number of serious errors unitwide', 'errors', 'serious errors', 'serious medical errors made by resident physicians, assessed by intensive surveillance, including direct observation and chart review']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0376531', 'cui_str': 'Errors, Medical'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0541653', 'cui_str': 'Chart evaluation by healthcare professional'}]",,0.0840156,"The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71).","[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Landrigan', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Sullivan', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Barger', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Sanderson', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Wright', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Conor S', 'Initials': 'CS', 'LastName': ""O'Brien"", 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Qadri', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'St Hilaire', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Halbower', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Segar', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'McGuire', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Vitiello', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Horacio O', 'Initials': 'HO', 'LastName': 'de la Iglesia', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Poynter', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Pearl L', 'Initials': 'PL', 'LastName': 'Yu', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Stone', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Czeisler', 'Affiliation': ""From the Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital (C.P.L., S.A.R., J.P.S., L.K.B., C.S.O., S.Q., M.A.S.H., S.W.L., C.A.C.), the Division of Sleep Medicine, Harvard Medical School (C.P.L., S.A.R., L.K.B., M.A.S.H., S.W.L., C.A.C.), and the Division of General Pediatrics, Department of Pediatrics (C.P.L.), and the Division of Critical Care Medicine, Department of Anesthesiology, Critical Care, and Pain Medicine (A.L.S.), Boston Children's Hospital - all in Boston; the University of California, San Francisco (E.V., K.L.S.), and California Pacific Medical Center Research Institute (K.L.S.), San Francisco; the Sleep and Chronobiology Laboratory, Department of Integrative Physiology, University of Colorado Boulder, Boulder (K.P.W.), and Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (A.C.H.); the University of Iowa Stead Family Children's Hospital, Iowa City (J.L.S.); Seattle Children's Hospital (J.K.M.) and the University of Washington (M.V.V., H.O.I.), Seattle; Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati (S.E.P.); University of Virginia Children's Hospital, Charlottesville (P.L.Y.); and the Department of Neurology and Center for Circadian and Sleep Medicine, Northwestern University, Feinberg School of Medicine, Chicago (P.C.Z.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1900669']
1315,32449296,Short-term neurophysiological effects of sensory pathway neurorehabilitation strategies on chronic poststroke oropharyngeal dysphagia.,"BACKGROUND


Neurorehabilitation strategies for chronic poststroke (PS) oropharyngeal dysphagia (OD) have been mainly focused on the neurostimulation of the pharyngeal motor cortex with only marginal effects. In contrast, treatments targeting the PS oropharyngeal sensory pathway dysfunction offer very promising results, but there is little knowledge on the underlying mechanisms. We aimed to explore the neurophysiological mechanisms behind the effect of three sensory neurostimulation strategies.
METHODS


We carried out a randomized two-blinded parallel group's crossover sham-controlled clinical trial in 36 patients with unilateral stroke and chronic unsafe swallow to investigate the effect of repetitive transcranial magnetic stimulation (rTMS) of the primary sensory cortex (A), oral capsaicin (B) and intra-pharyngeal electrical stimulation (IPES; C). The effect was evaluated immediately after the interventions with videofluoroscopy (VFS) and motor/sensory evoked potentials (MEP/SEP).
KEY RESULTS


Interventions induced no changes in the biomechanics of the swallow response during VFS. However, an enhancement of motor cortex excitability (latency shortening and increased size of thenar MEP) was found with active interventions (A + B + C, and B/C alone; P < .05 for all) but not with sham. Active but not sham interventions shortened pharyngeal SEP latency in the ipsilesional hemisphere (A + B + C: P2-peak, P = .039; A: N2-peak, P = .034) and antagonized the physiological habituation in pharyngeal MEP (A + B + C and A alone, P < .05 for both).
CONCLUSIONS AND INFERENCES


Sensory pathway neurostimulation strategies caused immediate enhancement of motor cortex excitability with peripheral strategies (capsaicin and IPES) and of pharyngeal sensory conduction with rTMS. These changes support the use of sensory neurorehabilitation strategies in promoting swallow recovery in chronic PS-OD.",2020,"A: N2-peak, P = .034) and antagonized the physiological habituation in pharyngeal MEP (A + B + C and A alone, P < .05 for both).
","['chronic poststroke (PS) oropharyngeal dysphagia (OD', '36 patients with unilateral stroke and chronic unsafe swallow']","['videofluoroscopy (VFS) and motor/sensory evoked potentials (MEP/SEP', 'sensory pathway neurorehabilitation strategies', 'sensory neurorehabilitation strategies', 'repetitive transcranial magnetic stimulation (rTMS) of the primary sensory cortex (A), oral capsaicin (B) and intra-pharyngeal electrical stimulation (IPES; C']","['motor cortex excitability (latency shortening and increased size of thenar MEP', 'biomechanics of the swallow response', 'chronic poststroke oropharyngeal dysphagia', 'pharyngeal SEP latency']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal dysphagia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0204096', 'cui_str': 'Neurological rehabilitation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0230374', 'cui_str': 'Thenar region structure'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal dysphagia'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}]",36.0,0.0786383,"A: N2-peak, P = .034) and antagonized the physiological habituation in pharyngeal MEP (A + B + C and A alone, P < .05 for both).
","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Cabib', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Weslania', 'Initials': 'W', 'LastName': 'Nascimento', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Rofes', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Viridiana', 'Initials': 'V', 'LastName': 'Arreola', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Tomsen', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Mundet', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Palomeras', 'Affiliation': 'Neurology Department, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Michou', 'Affiliation': 'Technological Educational Institute Western Greece, Patras, Greece.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Clavé', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ortega', 'Affiliation': 'Gastrointestinal Physiology Laboratory, Department of Surgery, Hospital de Mataró (Universitat Autónoma de Barcelona), Mataró, Spain.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13887']
1316,32445670,Long-term safety and efficacy of subcutaneous C1-inhibitor in older patients with hereditary angioedema.,"BACKGROUND


Patients aged 65 years and older with hereditary angioedema (HAE) owing to C1-inhibitor (C1-INH) deficiency may have an altered response to treatment and are at higher risk for treatment-related adverse events (AEs) because of comorbidities and polypharmacy.
OBJECTIVE


To investigate the safety and efficacy of subcutaneous C1 esterase inhibitor (C1-INH) in patients aged 65 years and older treated in an open-label extension of a phase 3 trial.
METHODS


Eligible patients (≥4 attacks for more than 2 consecutive months) were randomized to receive twice-weekly subcutaneous C1-INH with a dosage of 40 IU/kg or 60 IU/kg for 52 to 140 weeks. Safety end points and efficacy outcomes were evaluated for patients aged 65 years and above and younger than 65 years.
RESULTS


Of the 126 patients treated, 10 were 65 years and older (mean age [range], 68 [65-72 years]). A total of 8 of 10 patients had multiple comorbidities, and 6 of these 10 patients were taking more than 5 non-HAE-related drugs concomitantly. AEs occurring in more than 1 patient included injection site bruising (n = 2, related), injection site pain (n = 2, related), urinary tract infection (n = 2, unrelated), and diarrhea (n = 2, unrelated). No thromboembolic events or cases of anaphylaxis were reported. Two patients aged 65 years and older experienced unrelated serious AEs (dehydration and hypokalemia in 1 and pneumonia and an HAE attack leading to hospitalization in another). A total of 6 of 9 evaluable patients were responders, with a greater than or equal to 50% reduction in HAE attacks vs prestudy; 6 of 10 patients had less than 1 attack over 4 weeks and 3 were attack-free (median attack rate, 0.52 attacks per month).
CONCLUSION


Subcutaneous C1-INH was well-tolerated and effective in the management of HAE in patients aged 65 years and older with multiple comorbid conditions and polypharmacy.",2020,No thromboembolic events or cases of anaphylaxis were reported.,"['126 subjects treated', 'Patients ≥65 years old with hereditary angioedema (HAE', 'Eligible patients (≥4 attacks over 2 consecutive months', 'patients ≥65 years old treated in an open-label extension of a phase 3 trial', 'Two subjects ≥65 years old experienced unrelated serious AEs (dehydration and hypokalemia in one and pneumonia and an HAE attack leading to hospitalization in another', 'patients aged ≥65 and <65 years', 'Older Patients With Hereditary Angioedema', 'subjects ≥65 years old with multiple comorbid conditions and polypharmacy', 'Eight of 10 subjects had multiple comorbidities; 6/10 were taking >5 non-HAE-related drugs concomitantly', ' 10 were ≥65 years old (mean age [range], 68 [65-72 years']","['Subcutaneous C1-Inhibitor', 'C1-INH (SC', 'subcutaneous (SC) C1-INH']","['Safety endpoints and efficacy outcomes', 'tolerated and effective', 'urinary tract infection', 'safety and efficacy', 'thromboembolic events', 'HAE attacks']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}]",,0.0321857,No thromboembolic events or cases of anaphylaxis were reported.,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Allergy Section, Division of Immunology, Department of Internal Medicine, University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, Ohio. Electronic address: jonathan.bernstein@uc.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Schwartz', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation and University of Ottawa Medical School, Ottawa, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Baker Allergy, Asthma, and Dermatology Research Center, Portland, Oregon.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Farkas', 'Affiliation': 'Hungarian Angioedema Reference Center, Third Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Aygören-Pürsün', 'Affiliation': 'Klinikum der Johann Wolfgang-Goethe Universität, Klinik für Kinder- und Jugendmedizin, Frankfurt, Germany.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Bygum', 'Affiliation': 'Hereditary Angioedema Centre Denmark, Department of Dermatology, and Allergy Centre, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'CSL Behring, King of Prussia, Pennsylvania.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Feuersenger', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Pragst', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'University of California, San Diego School of Medicine, La Jolla, California.'}]","Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology",['10.1016/j.anai.2020.05.015']
1317,32445690,"Minocycline and celecoxib as adjunctive treatments for bipolar depression: a multicentre, factorial design randomised controlled trial.","BACKGROUND


Several small studies suggest that the adjunctive use of anti-inflammatory agents might improve depressive symptoms in bipolar disorder. However, there are few well designed, appropriately powered clinical trials assessing the efficacy of these novel treatment strategies. We aimed to assess the efficacy of adjunctive minocycline or celecoxib in this setting.
METHODS


This double-blind, 12-week, randomised, placebo-controlled trial was done in four outpatient psychiatric clinics in Pakistan. Eligible participants were adults (aged 18-65 years) with DSM-5 bipolar disorder (type I or II) and a major depressive episode. In a 2 × 2 factorial design, participants were randomly assigned (1:1:1:1) to receive either active minocycline plus active celecoxib, active minocycline plus placebo celecoxib, placebo minocycline plus active celecoxib, or placebo minocycline plus placebo celecoxib. The primary outcome was the mean change from baseline to week 12 in score on the 17-item Hamilton Depression Rating Scale (HAMD-17), assessed in all randomised participants (missing data were imputed and assumed to be missing at random). The trial was registered with ClinicalTrials.gov, NCT02703363.
FINDINGS


266 (17%) of 1542 patients assessed between May 1, 2016, and March 31, 2019, were randomly assigned to receive minocycline plus celecoxib (n=68), minocycline plus placebo (n=66), celecoxib plus placebo (n=66), or placebo plus placebo (n=66). From baseline to week 12, depressive symptoms as per HAMD-17 reduced in all four groups (from 24·5-25·2 to 11·3-12·8), but these reductions did not differ significantly between the groups. In terms of main effects, reductions in HAMD-17 did not differ for patients treated with minocycline (mean adjusted difference vs non-minocycline 1·48 [95% CI -0·41 to 3·36]; p=0·123) or for celecoxib (mean adjusted difference vs non-celecoxib -0·74 [-2·61 to 1·14]; p=0·443). Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
INTERPRETATION


We found no evidence that minocycline or celecoxib was superior to placebo for the treatment of bipolar depression. This large trial casts doubt on the potential therapeutic benefits of adjunctive anti-inflammatory drugs for the acute management of bipolar depression.
FUNDING


Stanley Medical Research Institute.",2020,"Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
","['266 (17%) of 1542 patients assessed between May 1, 2016, and March 31, 2019', 'four outpatient psychiatric clinics in Pakistan', 'bipolar depression', 'Eligible participants were adults (aged 18-65 years) with DSM-5 bipolar disorder (type I or II) and a major depressive episode']","['Minocycline and celecoxib', 'active minocycline plus active celecoxib, active minocycline plus placebo celecoxib, placebo minocycline plus active celecoxib, or placebo minocycline plus placebo celecoxib', 'adjunctive minocycline or celecoxib', 'minocycline plus placebo', 'celecoxib plus placebo', 'minocycline', 'placebo plus placebo', 'celecoxib', 'minocycline plus celecoxib', 'placebo']","['HAMD-17', 'depressive symptoms as per HAMD-17', 'mean change from baseline to week 12 in score on the 17-item Hamilton Depression Rating Scale (HAMD-17', 'Rates of serious adverse effects', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.814161,"Rates of serious adverse effects did not differ between groups (31 participants had a manic switch, two self-harmed, and one died in a motor vehicle accident).
","[{'ForeName': 'Muhammad Ishrat', 'Initials': 'MI', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada. Electronic address: ishrat.husain@camh.ca.'}, {'ForeName': 'Imran B', 'Initials': 'IB', 'LastName': 'Chaudhry', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK; Pakistan Institute of Learning and Living, Karachi, Pakistan; Department of Pyschiatry, Dow University of Health Sciences, Karachi, Pakistan; Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Ameer B', 'Initials': 'AB', 'LastName': 'Khoso', 'Affiliation': 'Pakistan Institute of Learning and Living, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Omair', 'Initials': 'MO', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Moin A', 'Initials': 'MA', 'LastName': 'Ansari', 'Affiliation': 'Department of Psychiatry, Liaquat University of Medical and Health Sciences, Hyderabad, Pakistan.'}, {'ForeName': 'Haider A', 'Initials': 'HA', 'LastName': 'Naqvi', 'Affiliation': 'Department of Pyschiatry, Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Fareed A', 'Initials': 'FA', 'LastName': 'Minhas', 'Affiliation': 'Institute of Psychiatry, Rawalpindi Medical College, Rawalpindi, Pakistan.'}, {'ForeName': 'Andre F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Meyer', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Deakin', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30138-3']
1318,32453453,Ultra-Early Blood Pressure Reduction Attenuates Hematoma Growth and Improves Outcome in Intracerebral Hemorrhage.,"OBJECTIVE


The aim was to investigate whether intensive blood pressure treatment is associated with less hematoma growth and better outcome in intracerebral hemorrhage (ICH) patients who received intravenous nicardipine treatment ≤2 hours after onset of symptoms.
METHODS


A post-hoc exploratory analysis of the Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-2) trial was performed. This was a multicenter, international, open-label, randomized clinical trial, in which patients with primary ICH were allocated to intensive versus standard blood pressure treatment with nicardipine ≤4.5 hours after onset of symptoms. We have included 913 patients with complete imaging and follow-up data in the present analysis.
RESULTS


Among the 913 included patients, 354 (38.7%) had intravenous nicardipine treatment initiated within 2 hours. In this subgroup of patients treated within 2 hours, the frequency of ICH expansion was significantly lower in the intensive blood pressure reduction group compared with the standard treatment group (p = 0.02). Multivariable analysis showed that ultra-early intensive blood pressure treatment was associated with a decreased risk of hematoma growth (odds ratio, 0.56; 95% confidence interval [CI], 0.34-0.92; p = 0.02), higher rate of functional independence (odds ratio, 2.17; 95% CI, 1.28-3.68; p = 0.004), and good outcome (odds ratio, 1.68; 95% CI, 1.01-2.83; p = 0.048) at 90 days. Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
INTERPRETATION


In a subgroup of ICH patients with elevated blood pressure given intravenous nicardipine ≤2 hours after onset of symptoms, intensive blood pressure reduction was associated with reduced hematoma growth and improved functional outcome. ANN NEUROL 2020.",2020,"Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
","['Intracerebral Hemorrhage', '913 patients with complete imaging and follow-up data in the present analysis', 'ICH patients who received intravenous', 'patients with primary ICH']","['intensive blood pressure treatment', 'intensive versus standard blood pressure treatment with nicardipine', 'Ultra-early Blood Pressure Reduction', 'nicardipine']","['hematoma growth and improved functional outcome', 'modified Rankin Scale score distribution', 'rate of functional independence', 'Ultra-early intensive blood pressure reduction', 'elevated blood pressure', 'risk of hematoma growth', 'frequency of ICH expansion', 'intensive blood pressure reduction']","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}]",913.0,0.129574,"Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Warren', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, St. Cloud, MN, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morotti', 'Affiliation': 'Department of Neurology and Neurorehabilitation, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Guido J', 'Initials': 'GJ', 'LastName': 'Falcone', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Division of Neurology, McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dar', 'Initials': 'D', 'LastName': 'Dowlatshahi', 'Affiliation': 'Department of Medicine (Neurology), Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Goldstein', 'Affiliation': 'Division of Neurocritical Care and Emergency Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}]",Annals of neurology,['10.1002/ana.25793']
1319,32456996,Is dermis fat arthroplasty better than plain gap arthroplasty? A prospective randomised controlled trial.,"The aim of the study was to compare interpositional arthroplasty using a dermis fat graft with gap arthroplasty in the management of ankylosis of the temporomandibular joint (TMJ). We organised a prospective randomised study of 22 patients who presented with ankylosis of the TMJ. They were randomised to be treated with either plain gap arthroplasty or dermis fat arthroplasty, and the predictor variable was the method of treatment. The primary outcome variables were mouth opening and pain on jaw exercises. Pain and interincisal opening were measured on day 5, day 14, at the end of one month, and at six months, one year, two years, and three years. There was a significant difference between the two groups on two occasions: postoperative day 5 (p=0.013) and at one year (p=0.018). The mean (SD) scores for mouth-opening were higher in the dermis fat group at all times (41.20 (4.69) mm compared with 39.50 (2.46) mm in gap arthroplasty at two years, and 41.40 (3.60) mm compared with 38.9 (2.02) mm at three years). The visual analogue pain scores were also lower in the dermis fat graft group. The groups showed similar results at the end of three years follow up, with no significant difference in mouth opening. We conclude therefore that the two techniques have similar outcomes in the management of ankylosis of the TMJ.",2020,There was a significant difference between the two groups on two occasions: postoperative day 5 (p=0.013) and at one year (p=0.018).,"['22 patients who presented with ankylosis of the TMJ', 'ankylosis of the temporomandibular joint (TMJ']","['plain gap arthroplasty or dermis fat arthroplasty', 'interpositional arthroplasty using a dermis fat graft with gap arthroplasty']","['Pain and interincisal opening', 'visual analogue pain scores', 'mouth opening', 'mean (SD) scores for mouth-opening', 'mouth opening and pain on jaw exercises']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C2931375', 'cui_str': 'Ankylosis of temporomandibular joint'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}]","[{'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",22.0,0.111565,There was a significant difference between the two groups on two occasions: postoperative day 5 (p=0.013) and at one year (p=0.018).,"[{'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Andrade', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: drnnadrade@yahoo.co.in.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: agg.neha61@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mathai', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: paulmathai89@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nerurkar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: nerurkarshibani@gmail.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Desai', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: harshdesai1992@gmmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Nair Hospital Dental College, Mumbai, India. Electronic address: varshagupta391@gmail.com.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.04.045']
1320,32462791,"Prospective, Multicenter Feasibility Study to Evaluate Differential Target Multiplexed Spinal Cord Stimulation Programming in Subjects With Chronic Intractable Back Pain With or Without Leg Pain.","OBJECTIVE


This prospective, open-label, multicenter study evaluated the feasibility of spinal cord stimulation (SCS) therapy programming for chronic low back pain that uses multiple electrical pulsed signals (Differential Target Multiplexed).
METHODS


Twenty-five SCS candidates with low back pain equal to or greater than lower limb pain were enrolled at 7 sites in the United States. The subjects evaluated standard and Differential Target Multiplexed programs, each for 4 ± 1 days. A commercially available SCS trial system was used for standard SCS therapy programming. During the trialing of the multiplexed programs, implanted temporary leads were connected to an investigational external trial stimulator system.
RESULTS


Twenty subjects concluded the study. The mean baseline numeric pain rating scale (NPRS) score for low back pain was 7.4, with a mean age of 62.4 years and mean pain duration of 18.0 years. Significant relief in back pain was observed for both treatments, with significantly better response with multiplexed programming. At the end of the trial period, subjects reported a reduction in their mean NPRS score from baseline to 4.2 after standard programming and to 2.4 after Differential Target Multiplexed programming. The difference between standard and multiplexed programming was significant. The responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming. Eighty-five percent of subjects who evaluated both programming approaches preferred Differential Target Multiplexed SCS.
CONCLUSION


In this difficult-to-treat patient population, subjects reported significant reduction in chronic back pain when using multiplexed programming. A randomized clinical trial is needed to confirm the results from this feasibility study.",2020,Responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming.,"['Subjects with Chronic Intractable Back Pain with or Without Leg Pain', 'Twenty subjects concluded the study', 'Twenty-five SCS candidates with low back pain equal to or greater than lower limb pain were enrolled at 7 sites in the United States']","['spinal cord stimulation (SCS) therapy programming', 'Differential Target Multiplexed SCS Programming']","['Responder rate for low back pain relief', 'NPRS', 'chronic back pain', 'Mean baseline numerical pain rating score (NPRS', 'back pain']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443199', 'cui_str': 'Differential'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",20.0,0.0338046,Responder rate for low back pain relief was 50% for standard programming and 80% for Differential Target Multiplexed programming.,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Fishman', 'Affiliation': 'Center for Interventional Pain and Spine, Exton, Pennsylvania, U.S.A.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Calodney', 'Affiliation': 'Precision Spine Care, Tyler, Texas, U.S.A.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Kim', 'Affiliation': 'Center for Interventional Pain and Spine, Exton, Pennsylvania, U.S.A.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Slezak', 'Affiliation': 'Interventional Spine Medicine, Barrington, New Hampshire, U.S.A.'}, {'ForeName': 'Ramsin', 'Initials': 'R', 'LastName': 'Benyamin', 'Affiliation': 'Millennium Pain Center, Bloomington, Illinois, U.S.A.'}, {'ForeName': 'Atiq', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Decatur Memorial Hospital, Decatur, Illinois, U.S.A.'}, {'ForeName': 'Eliezer', 'Initials': 'E', 'LastName': 'Soto', 'Affiliation': 'Millennium Pain Center-Libertyville, Libertyville, Illinois, U.S.A.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Swedish Medical Center, Seattle, Washington, U.S.A.'}, {'ForeName': 'Asteghik', 'Initials': 'A', 'LastName': 'Hacobian', 'Affiliation': 'Interventional Spine Medicine, Barrington, New Hampshire, U.S.A.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Griffith', 'Affiliation': 'Precision Spine Care, Tyler, Texas, U.S.A.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Swedish Medical Center, Seattle, Washington, U.S.A.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Vallejo', 'Affiliation': 'Millennium Pain Center, Bloomington, Illinois, U.S.A.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12908']
1321,32460145,Effect of cognitive rehabilitation on neuropsychological and semiecological testing and on daily cognitive functioning in multiple sclerosis: The REACTIV randomized controlled study.,"BACKGROUND


Specific cognitive rehabilitation (SCR) has been suggested for multiple sclerosis (MS). A randomized controlled trial (RCT) evaluating the therapeutic effects of SCR is necessary.
OBJECTIVE


To demonstrate the superiority of a SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning.
METHODS


A single-blind RCT compared SCR and NSI in patients with MS with cognitive complaint. Both programs included 50 individual sessions, 3 times a week for 17 weeks in a real-world setting. The primary end-point was NP assessment. Secondary end-points included semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment. Maintenance of the effects at 8 months was studied.
RESULTS


Of the 35 patients, 18 completed the SCR, and 17 completed the NSI. Several NP and semiecological scores improved significantly more after SCR than after NSI. More NP scores improved significantly after SCR than after NSI. SCR improved daily cognitive functioning. Most improvements were maintained at 8 months.
CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.",2020,"CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","['35 patients', 'patients with MS with cognitive complaint', 'multiple sclerosis']","['Specific cognitive rehabilitation (SCR', 'cognitive rehabilitation', 'SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning']","['SCR improved daily cognitive functioning', 'semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment', 'NP scores', 'Several NP and semiecological scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.067952,"CONCLUSION


SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lamargue', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Koubiyr', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deloire', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saubusse', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Charre-Morin', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moroso', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Coupé', 'Affiliation': 'Laboratoire Bordelais de Recherche en Informatique, UMR CNRS 5800, PICTURA, F-33405 Talence, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France. Electronic address: bruno.brochet@chu-bordeaux.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116929']
1322,32464334,"Prevalence, incidence, and natural history of HPV infection in adult women ages 24 to 45 participating in a vaccine trial.","OBJECTIVES


The natural history of human papillomavirus (HPV) infection has been studied extensively in young women; this study investigated HPV infection in adult women.
METHODS


Data from 3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18) vaccine were used to calculate prevalence of anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59). Incidence of infections and persistent infections was estimated for 989 placebo recipients naive to all 14 HPV types at baseline. Age-adjusted hazard ratios were calculated for various sociodemographic factors.
RESULTS


Prevalence of anogenital infection was highest in France at 29.2% (9vHPV types) and 21.7% (non-vaccine types) and lowest in the Philippines at 7.6% (9vHPV types) and 5.1% (non-vaccine types). Overall, HPV incidence (per 100 person-years) was 5.2 (9vHPV types) and 4.7 (non-vaccine types), and incidence of persistent infection was 2.7 (9vHPV types) and 2.1 (non-vaccine types). Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
CONCLUSIONS


Because mid-adult women acquire new HPV infections, administration of the 9vHPV vaccine could reduce HPV-related morbidity and mortality in this population.",2020,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","['3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18', 'young women', 'adult women ages 24 to 45 participating in a vaccine trial', 'adult women']","['9vHPV vaccine', 'anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59', 'vaccine']","['Overall, HPV incidence', 'incidence of persistent infection', 'Prevalence of anogenital infection', 'Prevalence, incidence, and natural history of HPV infection', 'HPV-related morbidity and mortality', 'Incidence of infections and persistent infections']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",3817.0,0.148337,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","[{'ForeName': 'Daron G', 'Initials': 'DG', 'LastName': 'Ferris', 'Affiliation': 'Department of Obstetrics and Gynecology, Georgia Cancer Center, 1120 15th Street, Augusta University, Augusta, GA, 30912, USA. Electronic address: dferris@augusta.edu.'}, {'ForeName': 'Darron R', 'Initials': 'DR', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Van Nuys Medical Science Building, Suite 224, 635 Barnhill Drive, Indianapolis, IN 46202, USA. Electronic address: darbrow@iupui.edu.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Giuliano', 'Affiliation': 'Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33612, USA. Electronic address: Anna.Giuliano@moffitt.org.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Myers', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Duke Medicine Cir, Durham, NC, 27710, USA. Electronic address: evan.myers@duke.edu.'}, {'ForeName': 'Elmar A', 'Initials': 'EA', 'LastName': 'Joura', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Comprehensive Cancer Center, Weinheimergrass 2, Medical University of Vienna, Vienna, 1160, Austria. Electronic address: elmar.joura@gmail.com.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Garland', 'Affiliation': ""Centre for Women's Infectious Diseases, The Royal Women's Hospital, Department of Obstetrics and Gynaecology, University of Melbourne, Murdoch Children's Research Institute, RWH, Locked Bag 300, Cnr Gratton St and Flemington Rd, Parkville, Victoria, 3052, Australia. Electronic address: Suzanne.Garland@thewomens.org.au.""}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Kjaer', 'Affiliation': 'Danish Cancer Society Research Center, Copenhagen Denmark and Department of Gynecology, Rigshospitalet, Blegdamsvej 9, University of Copenhagen, Copenhagen, 2200, Denmark. Electronic address: susanne@cancer.dk.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Perez', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: gonzalopamaya@gmail.com.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Saah', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alfred_saah@merck.com.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Luxembourg', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alain_luxembourg@merck.com.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Velicer', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: christine_velicer@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100202']
1323,32580074,Impact of electrical cardioversion on quality of life for patients with symptomatic persistent atrial fibrillation: Is there a treatment expectation effect?,"It is assumed that electrical cardioversion (ECV) improves the quality of life (QoL) of patients with atrial fibrillation (AF) by restoring sinus rhythm (SR).
OBJECTIVE


We examined the effect of ECV and rhythm status on QoL of patients with symptomatic persistent AF in a randomized controlled trial.
METHOD


The elective cardioversion for prevention of symptomatic atrial fibrillation trial examined the efficacy of dronedarone around the time of ECV in maintaining SR. Quality of life was measured with the University of Toronto Atrial Fibrillation Severity Scale. The primary outcome was the change in AF symptom severity (∆AFSS) score over 6 months (0-35 points, with higher scores reflecting worse QoL and a minimal clinically important difference defined as ∆AFSS ≥3 points). Multivariable linear regression was performed to identify factors associated with changes in QoL.
RESULTS


We included 148 patients with complete AFSS scores at baseline and 6 months. Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups). After adjustment of baseline covariates, maintenance of SR was associated with QoL improvement (ΔAFSS: -3.8 points, 95% CI: -6.0 to -1.6 points, P < .01).
CONCLUSIONS


Maintenance of SR was associated with clinically relevant improvement in patients' QoL at 6 months. Patients with AF recurrence had a small but still relevant improvement in their QoL, potentially due to factors other than sinus rhythm.",2020,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","['Patients with AF recurrence', 'patients with symptomatic persistent atrial fibrillation', '148 patients with complete AFSS scores at baseline and 6 months', 'patients with symptomatic persistent AF', 'patients with atrial fibrillation (AF) by restoring sinus rhythm (SR']","['electrical cardioversion', 'dronedarone', 'ECV', 'electrical cardioversion (ECV']","['quality of life', 'University of Toronto Atrial Fibrillation Severity Scale', 'quality of life (QoL', 'change in AF symptom severity (∆AFSS) score', 'Quality of life', 'AF relapse', 'unsuccessful ECV', 'QoL improved irrespective of rhythm status (ΔAFSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}]","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0766326', 'cui_str': 'dronedarone'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",148.0,0.042951,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","[{'ForeName': 'Andrew C T', 'Initials': 'ACT', 'LastName': 'Ha', 'Affiliation': 'Peter Munk Cardiac Center, University Health Network, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: andrew.ha@uhn.ca.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi, Montreal, Quebec, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Klein', 'Affiliation': 'Arrhythmia Service, University Hospital, Western University, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi US, Bridgewater, NJ, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': ""Department of Medicine, University of Toronto, Toronto, Ontario, Canada; St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}]",American heart journal,['10.1016/j.ahj.2020.05.004']
1324,32446470,"Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages.","OBJECTIVE


To evaluate the effect of different modalities of centralized reminder/recall (autodialer, text, mailed reminders) on increasing childhood influenza vaccination.
STUDY DESIGN


Two simultaneous randomized clinical trials conducted from October 2017 to April 1, 2018, in New York State and Colorado. There were 61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices) who were randomized to different centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control). The message content was similar across modalities. Up to 3 reminders were sent for intervention arms. The main outcome measure was receipt of ≥1 influenza vaccine.
RESULTS


In New York, compared with the control arm (26.6%), postintervention influenza vaccination rates in the autodialer arm (28.0%) were 1.4 percentage points higher (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10), but the rates for text (27.6%) and mail (26.8%) arms were not different from controls. In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively. Compared with the control arm, the incremental cost per additional vaccine delivered was $20 (New York) and $16 (Colorado) for autodialer messages.
CONCLUSIONS


Centralized reminder/recall for childhood influenza vaccine was most effective via autodialer, less effective via mail, and not effective via text messages. The impact of each modality was modest. Compared with no reminders, the incremental cost per additional vaccine delivered was also modest for autodialer messages.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03294473 and NCT03246100.",2020,"In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively.","['Influenza Vaccinations', '61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices', 'October 2017 to April 1, 2018, in New York State and Colorado']","['centralized reminder/recall (autodialer, text, mailed reminders', 'centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control']","['postintervention influenza vaccination rates', 'receipt of ≥1 influenza vaccine']","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]",61931.0,0.279722,"In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Szilagyi', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA. Electronic address: pszilagyi@mednet.ucla.edu.""}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Albertin', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Alison W', 'Initials': 'AW', 'LastName': 'Saville', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Breck', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Helmkamp', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Whittington', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Roth', 'Affiliation': 'Colorado Immunization Information System, Colorado Department of Public Health and Environment, Denver, CO.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Rand', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Department of Pediatrics, Children's Mercy, Kansas City, MO.""}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Hoefer', 'Affiliation': 'New York State Immunization Information System, New York State Department of Health, New York, NY.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.020']
1325,32446591,Comparison of the postoperative and follow-up accuracy of articulator model surgery and virtual surgical planning in skeletal class III patients.,"The aim of this study was to evaluate the postoperative and follow-up accuracy of using an intermediate occlusal splint between articulator model surgery (AMS) and virtual surgical planning (VSP) in double-jaw operations. Thirty skeletal class III patients were randomly allocated to have AMS or VSP. In the AMS group surgical planning was done through conventional articulator model surgery, and an intermediate occlusal splint made of acrylic resin was used. In the VSP group the surgical simulation was done virtually, and the same intermediate splint was used in the software and then fabricated using rapid prototyping technology. Preoperatively, one week postoperatively, and 1∼2-years later we obtained follow-up cone-beam computed tomographic (CT) images of each patient. Absolute linear differences between planned and actual outcomes, as well as planned and follow-up outcomes, were evaluated. There was no significant difference in either postoperative accuracy or follow-up accuracy between the methods, and there was no significant difference in the rate of skeletal relapse. Planning transfer by intermediate splint might therefore be the dominant factor in the final inaccuracies. The potentially greater accuracy of VSP may be realised with the help of new positioning devices instead of an intermediate splint.",2020,"There was no significant difference in either postoperative accuracy or follow-up accuracy between the methods, and there was no significant difference in the rate of skeletal relapse.","['Thirty skeletal class III patients', 'skeletal class III patients']","['VSP', 'articulator model surgery and virtual surgical planning', 'AMS or VSP', 'intermediate occlusal splint between articulator model surgery (AMS) and virtual surgical planning (VSP']","['postoperative accuracy', 'rate of skeletal relapse']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0003911', 'cui_str': 'Articulators'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",30.0,0.0157353,"There was no significant difference in either postoperative accuracy or follow-up accuracy between the methods, and there was no significant difference in the rate of skeletal relapse.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Orthodontics, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China; State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ye', 'Affiliation': ""Department of Orthodontics, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, School of Medicine, No. 639 Zhizaoju Road, Shanghai, PR China.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China. Electronic address: lijingtao86@163.com.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lai', 'Affiliation': 'State Key Laboratory of Oral Diseases & National Clinical Research Centre for Oral Diseases, Department of Orthodontics, West China Hospital of Stomatology, Sichuan University, 14 Ren Min Nan Road, Chengdu, 610041, PR China. Electronic address: wenlilai@scu.edu.cn.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.04.032']
1326,32447394,Corrigendum to: Reducing the initial number of rituximab maintenance-therapy infusions for ANCA-associated vasculitides: randomized-trial post-hoc analysis.,,2020,,[],[],[],[],[],[],,0.042812,,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Charles', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Dechartres', 'Affiliation': ""Sorbonne Universitù, Institut National de la Santù et de la Recherche Médicale (INSERM), Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP. Sorbonne Université, Hôpital Pitié Salpêtriére, Département de Santé Publique, Paris.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Terrier', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Cohen', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Faguer', 'Affiliation': ""Département de Néphrologie et Transplantation d'Organes, Centre Hospitalier Universitaire (CHU) de Toulouse, Toulouse.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Huart', 'Affiliation': ""Département de Néphrologie et Transplantation d'Organes, Centre Hospitalier Universitaire (CHU) de Toulouse, Toulouse.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamidou', 'Affiliation': 'Service de Médecine Interne, Hôtel-Dieu, CHU, Nantes.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Agard', 'Affiliation': 'Service de Médecine Interne, Hôtel-Dieu, CHU, Nantes.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Bonnotte', 'Affiliation': 'Service de Médecine Interne et Immunologie Clinique, CHU de Dijon, INSERM, UMR 1098, Université de Bourgogne Franche-Comté, FHU INCREASE, Dijon.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Samson', 'Affiliation': 'Service de Médecine Interne et Immunologie Clinique, CHU de Dijon, INSERM, UMR 1098, Université de Bourgogne Franche-Comté, FHU INCREASE, Dijon.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Karras', 'Affiliation': 'Centre de Néphrologie et de Transplantation Rénale, Unité de Néphrologie, APHP, Hôpital Européen Georges-Pompidou, Université Paris Descartes, Paris.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Jourde-Chiche', 'Affiliation': 'Aix-Marseille Université, Centre de Néphrologie et de Transplantation Rénale, AP-HM, Hôpital de la Conception, Marseille.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lifermann', 'Affiliation': 'Service de Médecine Interne Hématologie, CH de Dax, Dax.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gobert', 'Affiliation': 'Hôpital Général Henri-Duffaut, Avignon.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hanrotel-Saliou', 'Affiliation': 'Service de Néphrologie, Dialyse et Transplantation Rénale, Hôpital la Cavale Blanche, CH Régionale Universitaire Brest, Brest.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Godmer', 'Affiliation': 'Département de Médecine Interne, CH Bretagne Atlantique de Vannes, Vannes.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Martin-Silva', 'Affiliation': 'Unité de Médecine Interne, CHU de Caen, Caen.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Pugnet', 'Affiliation': 'Service de Médecine Interne, CHU de Toulouse, Toulouse.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Matignon', 'Affiliation': 'Service de Néphrologie, APHP, CHU Henri-Mondor, Créteil.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Aumaitre', 'Affiliation': 'Service de Médecine Interne, CHU, Hôpital Gabriel-Montpied, Clermont-Ferrand.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Viallard', 'Affiliation': 'Service de Médecine Interne et Maladies Infectieuses, CHU de Bordeaux, Pessac.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maurier', 'Affiliation': 'Service de Médecine Interne, Hôpitaux Privés de Metz, Metz.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Meaux-Ruault', 'Affiliation': 'Service de Médecine Interne, CHU Jean-Minjoz, Besançon.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Rivière', 'Affiliation': 'Service de Médecine Interne, CHU de Montpellier, Montpellier.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Service de Rhumatologie, Hôpital de Hautepierre, CHU de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Puéchal', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Mouthon', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Guillevin', 'Affiliation': 'Centre de Référence Maladies Systémiques et Auto-Immunes Rares, Université Paris Descartes, APHP, Hôpital Cochin, Paris.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa222']
1327,32453116,Goal Attainment Scaling Rehabilitation Improves Satisfaction with Work Activities for Younger Working Patients After Knee Arthroplasty: Results from the Randomized Controlled ACTION Trial.,"BACKGROUND


Knee arthroplasty (KA) is increasingly performed in relatively young, active patients. This heterogeneous patient population often has high expectations, including work resumption and performance of knee-demanding leisure-time activities. Goal attainment scaling (GAS) may personalize rehabilitation by using patient-specific, activity-oriented rehabilitation goals. Since unmet expectations are a leading cause of dissatisfaction after KA, personalized rehabilitation may improve patient satisfaction. We hypothesized that, compared with standard rehabilitation, GAS-based rehabilitation would result in younger, active patients having higher satisfaction regarding activities after KA.
METHODS


We performed a single-center randomized controlled trial. Eligible patients were <65 years of age, working outside the home, and scheduled to undergo unicompartmental or total KA. The required sample size was 120 patients. Using GAS, patients developed personal activity goals with a physiotherapist preoperatively. These goals were used to monitor patients' goal attainment and provide goal-specific feedback during postoperative outpatient rehabilitation. Standard rehabilitation consisted of regular outpatient physiotherapy visits. The primary outcome measures were visual analogue scale (VAS) scores (scale of 0 to 100) for satisfaction regarding activities of daily living and work and leisure-time activities 1 year postoperatively, which were analyzed using generalized estimating equation models.
RESULTS


Patient satisfaction with work activities was significantly higher in the GAS group (β = 10.7 points, 98% confidence interval [CI] = 2.0 to 19.4 points) than in the control group. Patient satisfaction with activities of daily living and leisure-time activities did not differ between groups. We found no differences in VAS satisfaction scores between unicompartmental KA and total KA.
CONCLUSIONS


Personalized, goal-specific rehabilitation using GAS resulted in higher patient satisfaction with work activities, compared with standard rehabilitation, 1 year after KA.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"RESULTS


Patient satisfaction with work activities was significantly higher in the GAS group (β = 10.7 points, 98% confidence interval [CI] = 2.0 to 19.4 points) than in the control group.","['Younger Working Patients', 'After Knee Arthroplasty', 'relatively young, active patients', 'Eligible patients were <65 years of age, working outside the home, and scheduled to undergo unicompartmental or total KA']","['Knee arthroplasty (KA', 'Goal Attainment Scaling Rehabilitation', 'regular outpatient physiotherapy visits', 'standard rehabilitation, GAS-based rehabilitation']","['Patient satisfaction with activities of daily living and leisure-time activities', 'VAS satisfaction scores', 'visual analogue scale (VAS) scores (scale of 0 to 100) for satisfaction regarding activities of daily living and work and leisure-time activities 1 year postoperatively', 'Patient satisfaction with work activities', 'personal activity goals']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",120.0,0.240302,"RESULTS


Patient satisfaction with work activities was significantly higher in the GAS group (β = 10.7 points, 98% confidence interval [CI] = 2.0 to 19.4 points) than in the control group.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hoorntje', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Waterval-Witjes', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Koen L M', 'Initials': 'KLM', 'LastName': 'Koenraadt', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'P Paul F M', 'Initials': 'PPFM', 'LastName': 'Kuijer', 'Affiliation': 'Coronel Institute of Occupational Health, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Leendert', 'Initials': 'L', 'LastName': 'Blankevoort', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Rutger C I', 'Initials': 'RCI', 'LastName': 'van Geenen', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01471']
1328,32451130,Comparison of methemoglobin levels in food protein-induced enterocolitis syndrome and other gastrointestinal diseases in neonates.,"INTRODUCTION AND OBJECTIVES


Methemoglobinemia has been reported to be associated with severe food protein-induced enterocolitis syndrome (FPIES). However, no reports have evaluated methemoglobin (MHb) levels in FPIES without symptomatic methemoglobinemia or the usefulness of MHb measurement for the diagnostic prediction of FPIES. To evaluate the MHb levels of patients with neonatal-onset FPIES and determine whether MHb levels are higher in FPIES than in other gastrointestinal diseases.
PATIENTS AND METHODS


Eleven neonates with severe acute FPIES (FPIES group) and 139 neonates with other gastrointestinal diseases (non-FPIES group) were included in this study. Patient characteristics, symptoms, and venous blood test values (MHb, pH, HCO 3 - , and C-reactive protein) were evaluated.
RESULTS


The median age at onset was 16 days vs. 1 day; males comprised 64% vs. 46%, the median gestational age was 38 weeks vs. 38 weeks, the median birth weight was 2710g vs. 2880g, and the median hospitalization duration was 31 days vs. 6 days for the FPIES vs. non-FPIES groups, respectively. MHb (%) was higher in the FPIES group than in the non-FPIES group [median (range), 1.1 (0.6-10.9) and 0.6 (0.3-1.2), respectively, p<0.001]. There were no differences in terms of pH, HCO 3 - , and C-reactive protein (p>0.05). In the receiver operating characteristic analysis for FPIES diagnosis based on MHb (%), the area under the curve was 0.885, specificity was 97.1%, and sensitivity was 72.7% at a MHb cutoff of 1.0.
CONCLUSION


High MHb levels may help diagnose severe acute FPIES in neonates, but careful evaluation is needed.",2020,"There were no differences in terms of pH, HCO 3 - , and C-reactive protein (p>0.05).","['food protein-induced enterocolitis syndrome and other gastrointestinal diseases in neonates', 'patients with neonatal-onset FPIES', 'Eleven neonates with severe acute FPIES (FPIES group) and 139 neonates with other gastrointestinal diseases (non-FPIES group']",['Methemoglobinemia'],"['pH, HCO 3 - , and C-reactive protein (p>0.05', 'median birth weight', 'sensitivity', 'methemoglobin (MHb) levels', 'median hospitalization duration', 'Patient characteristics, symptoms, and venous blood test values (MHb, pH, HCO 3 - , and C-reactive protein', 'MHb levels']","[{'cui': 'C4268599', 'cui_str': 'Food-protein induced enterocolitis syndrome'}, {'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0025637', 'cui_str': 'Methemoglobinemia'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0025635', 'cui_str': 'Methemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",11.0,0.147106,"There were no differences in terms of pH, HCO 3 - , and C-reactive protein (p>0.05).","[{'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Makita', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan. Electronic address: r0947em@jichi.ac.jp.'}, {'ForeName': 'Sae', 'Initials': 'S', 'LastName': 'Kuroda', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan; Department of Pediatrics, Saitama Red Cross Hospital, Saitama 330-8553, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Kae', 'Initials': 'K', 'LastName': 'Itabashi', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Kawano', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Matsuura', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Asami', 'Initials': 'A', 'LastName': 'Maruyama', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Ichihashi', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center, Jichi Medical University, Saitama 330-8503, Japan.'}]",Allergologia et immunopathologia,['10.1016/j.aller.2020.01.007']
1329,32451161,TOPS - a randomized controlled trial of exercise and education to prevent recurrence of low back pain: statistical analysis plan.,"BACKGROUND


This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS).
OBJECTIVES


TOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP.
METHODS


TOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test.
DISCUSSION


This paper will provide a detailed description of the planned analyses for the TOPS trial.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12615000939594).",2020,"Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression.",['people who have recently recovered from an episode of LBP'],"['exercise and education classes', 'TOPS', 'exercise and education', 'physical therapist-led exercise and education program for 12 weeks or minimal intervention']","['survival curves', 'recurrence of low back pain (LBP', 'recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day', 'days to recurrence of an episode of LBP', 'Hazard ratios (HRs) and median survival times', 'number of adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.294755,"Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression.","[{'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Ferreira', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia. Electronic address: giovanni.ferreira@sydney.edu.au.'}, {'ForeName': 'Chung-Wei Christine', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': 'Matthew Leigh', 'Initials': 'ML', 'LastName': 'Stevens', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hancock', 'Affiliation': 'Department of Health Professions, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Wisbey-Roth', 'Affiliation': 'Bounce Back Active Rehabilitation Systems, Sydney, Australia.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2020.05.001']
1330,32455853,Low-Intensity Physical Exercise Improves Pain Catastrophizing and Other Psychological and Physical Aspects in Women with Fibromyalgia: A Randomized Controlled Trial.,"Fibromyalgia (FM) is a chronic syndrome characterized by widespread pain and other physical and psychological features. In this study, we aimed to analyze the effect of a low-intensity physical exercise (PE) program, combining endurance training and coordination, on psychological aspects (i.e., pain catastrophizing, anxiety, depression, stress), pain perception (i.e., pain acceptance, pressure pain threshold (PPT), and quality of life and physical conditioning (i.e., self-perceived functional capacity, endurance and functional capacity, power and velocity) in women with FM. For this purpose, a randomized controlled trial was carried out. Thirty-two women with FM were randomly allocated to a PE group (PEG, n = 16), performing an eight-week low-intensity PE program and a control group (CG, n = 16). Pain catastrophizing, anxiety, depression, stress, pain acceptance, PPT, quality of life, self-perceived functional capacity, endurance and functional capacity, power, and velocity were assessed before and after the intervention. We observed a significant improvement in all studied variables in the PEG after the intervention ( p  < 0.05). In contrast, the CG showed no improvements in any variable, which further displayed poorer values for PPT ( p  < 0.05). In conclusion, a low-intensity combined PE program, including endurance training and coordination, improves psychological variables, pain perception, quality of life, and physical conditioning in women with FM.",2020,"In contrast, the CG showed no improvements in any variable, which further displayed poorer values for PPT ( p  < 0.05).","['Women with Fibromyalgia', 'Thirty-two women with FM', 'women with FM']","['low-intensity physical exercise (PE) program, combining endurance training and coordination', 'Low-Intensity Physical Exercise', 'PE group (PEG, n = 16), performing an eight-week low-intensity PE program']","['psychological aspects (i.e., pain catastrophizing, anxiety, depression, stress), pain perception (i.e., pain acceptance, pressure pain threshold (PPT), and quality of life and physical conditioning (i.e., self-perceived functional capacity, endurance and functional capacity, power and velocity', 'Pain catastrophizing, anxiety, depression, stress, pain acceptance, PPT, quality of life, self-perceived functional capacity, endurance and functional capacity, power, and velocity', 'endurance training and coordination, improves psychological variables, pain perception, quality of life, and physical conditioning']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0450357', 'cui_str': '32'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",32.0,0.0914066,"In contrast, the CG showed no improvements in any variable, which further displayed poorer values for PPT ( p  < 0.05).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Izquierdo-Alventosa', 'Affiliation': 'Unidad de Biomecánica Clínica (UBIC Research Group), Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, 46010 València, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Inglés', 'Affiliation': 'Freshage Research Group, Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, Centro de Investigación Biomédica en Red Fragilidad y Envejecimiento Saludable (CIBERFES-ISCIII), Fundación Investigación del Hospital Clínico Universitario de Valencia (INCLIVA), 46010 València, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Cortés-Amador', 'Affiliation': 'Unidad de Biomecánica Clínica (UBIC Research Group), Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, 46010 València, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Gimeno-Mallench', 'Affiliation': 'Freshage Research Group, Department of Physiology, Faculty of Medicine, Universitat de València, Centro de Investigación Biomédica en Red Fragilidad y Envejecimiento Saludable (CIBERFES-ISCIII), Fundación Investigación del Hospital Clínico Universitario de Valencia (INCLIVA), 46010 València, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Chirivella-Garrido', 'Affiliation': 'Fundación Fivan, Centro de Neurorehabilitación, 46005 Valencia, Spain.'}, {'ForeName': 'Juri', 'Initials': 'J', 'LastName': 'Kropotov', 'Affiliation': 'N.P. Bechtereva Institute of Human Brain, Russian Academy of Science, 197022 St. Petersburg, Russia.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serra-Añó', 'Affiliation': 'Unidad de Biomecánica Clínica (UBIC Research Group), Department of Physiotherapy, Faculty of Physiotherapy, Universitat de València, 46010 València, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17103634']
1331,32459724,Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting.,"STUDY DESIGN


Two-year clinical and radiographic follow-up of a double-blind, multicenter, randomized, intra-patient controlled, non-inferiority trial comparing a bone graft substitute (AttraX Putty) with autograft in instrumented posterolateral fusion (PLF) surgery.
OBJECTIVES


The aim of this study was to compare PLF rates between 1 and 2 years of follow-up and between graft types, and to explore the role of bone grafting based on the location of the PLF mass.
SUMMARY OF BACKGROUND DATA


There are indications that bony fusion proceeds over time, but it is unknown to what extent this can be related to bone grafting.
METHODS


A total of 100 adult patients underwent a primary, single- or multilevel, thoracolumbar PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX Putty was disclosed. The contralateral posterolateral gutters were grafted with autograft. At 1-year follow-up, and in case of no fusion at 2 years, the fusion status of both sides of each segment was blindly assessed on CT scans. Intertransverse and facet fusion were scored separately. Difference in fusion rates after 1 and 2 years and between grafts were analyzed with a Generalized Estimating Equations (GEE) model (P < 0.05).
RESULTS


The 2-year PLF rate (66 patients) was 70% at the AttraX Putty and 68% at the autograft side, compared to 55% and 52% after 1 year (87 patients). GEE analysis demonstrated a significant increase for both conditions (odds ratio 2.0, 95% confidence interval 1.5-2.7, P < 0.001), but no difference between the grafts (P = 0.595). Ongoing bone formation was only observed between the facet joints.
CONCLUSION


This intra-patient controlled trial demonstrated a significant increase in PLF rate between 1 and 2 years after instrumented thoracolumbar fusion, but no difference between AttraX Putty and autograft. Based on the location of the PLF mass, this increase is most likely the result of immobilization instead of grafting.
LEVEL OF EVIDENCE


1.",2020,"GEE-analysis demonstrated a significant increase for both conditions (Odds ratio 2.0, 95% confidence interval 1.5 - 2.7, p < 0.001), but no difference between the grafts (p = 0.595).","['100 adult patients underwent a primary, single- or multilevel, thoracolumbar PLF']",['bone graft substitute (AttraX® Putty) with autograft in instrumented posterolateral fusion (PLF) surgery'],"['2-year PLF rate', 'Intertransverse and facet fusion', 'PLF rates', 'PLF rate', 'fusion rates', 'Increasing Fusion Rate', 'Ongoing bone formation']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",100.0,0.0881156,"GEE-analysis demonstrated a significant increase for both conditions (Odds ratio 2.0, 95% confidence interval 1.5 - 2.7, p < 0.001), but no difference between the grafts (p = 0.595).","[{'ForeName': 'A Mechteld', 'Initials': 'AM', 'LastName': 'Lehr', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'F Cumhur', 'Initials': 'FC', 'LastName': 'Oner', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Diyar', 'Initials': 'D', 'LastName': 'Delawi', 'Affiliation': 'Department of Orthopaedic Surgery, St. Antonius Hospital, Utrecht, The Netherlands.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Stellato', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hoebink', 'Affiliation': 'Department of Orthopaedic Surgery, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Diederik H R', 'Initials': 'DHR', 'LastName': 'Kempen', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Job L C', 'Initials': 'JLC', 'LastName': 'van Susante', 'Affiliation': 'Department of Orthopaedic Surgery, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Castelein', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Moyo C', 'Initials': 'MC', 'LastName': 'Kruyt', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Spine,['10.1097/BRS.0000000000003558']
1332,32466854,Preoperative Vitamin D Supplementation in Patients With Vitamin D Deficiency Undergoing Total Thyroidectomy.,"BACKGROUND


Transient hypocalcemia due to parathyroid gland or vessel manipulation is a common complication following thyroidectomy. Considering the role of 25-hydroxyvitamin D (25(OH)D) in calcium hemostasis, this study aimed to evaluate the effect of preoperative vitamin D supplementation on hypocalcemia incidence in thyroidectomy patients.
METHODS


In this randomized clinical trial, 100 patients scheduled for total thyroidectomy and suffering from preoperative moderate or severe vitamin D deficiency were enrolled. Patients were randomly allocated to either study or control groups using the sealed envelope method. Patients in the study group received vitamin D3 50,000-unit pearl weekly for 4 weeks prior to the operation. The control group received placebo. Total and ionized serum calcium levels were checked before surgery, the day after surgery, and 2 weeks postoperatively.
RESULTS


No significant difference was observed in terms of demographic data. During serial total calcium checks (5 episodes), total calcium levels changed significantly in patients who had received vitamin D supplements compared to the control group (P = 0.043). Symptomatic hypocalcemia incidence was significantly lower in patients supplemented with 25-hydroxyvitamin D (25(OH)D) (P = 0.04). Also, the requirement for intravenous calcium administration in order to treat the hypocalcemia symptoms was significantly lower in the study in comparison to the control group (P = 0.03).
CONCLUSIONS


Vitamin D supplementation in patients with vitamin D deficiency might lead to a lower incidence of early-onset symptomatic hypocalcemia; hence, requiring less calcium supplementation for the management of hypocalcemia.",2020,Symptomatic hypocalcemia incidence was significantly lower in patients supplemented with 25-hydroxyvitamin D (25(OH)D),"['100 patients scheduled for total thyroidectomy and suffering from preoperative moderate or severe vitamin D deficiency were enrolled', 'thyroidectomy patients', 'Patients With Vitamin D Deficiency Undergoing Total Thyroidectomy', 'patients with vitamin D deficiency']","['vitamin D supplements', 'preoperative vitamin D supplementation', 'Vitamin D supplementation', '25-hydroxyvitamin D (25(OH)D', 'Preoperative Vitamin D Supplementation', 'vitamin D3', 'placebo']","['Total and ionized serum calcium levels', 'demographic data', 'Symptomatic hypocalcemia incidence', 'total calcium levels', 'hypocalcemia symptoms', 'hypocalcemia incidence']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.0588547,Symptomatic hypocalcemia incidence was significantly lower in patients supplemented with 25-hydroxyvitamin D (25(OH)D),"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ramouz', 'Affiliation': 'Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Mahdie', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Cardiothoracic Surgery, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Cardiothoracic Surgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyedeh Shaghayegh', 'Initials': 'SS', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Seyed Ziaeddin', 'Initials': 'SZ', 'LastName': 'Rasihashemi', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: zia.hashemi@yahoo.com.'}]",The American journal of the medical sciences,['10.1016/j.amjms.2020.04.036']
1333,32470486,"Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19): A multicenter, single-blind, randomized controlled trial.","BACKGROUND


Accumulating evidence proposed Janus-associated kinase (JAK) inhibitors as therapeutic targets warranting rapid investigation.
OBJECTIVE


This study evaluated the efficacy and safety of ruxolitinib, a JAK1/2 inhibitor, for coronavirus disease 2019.
METHODS


We conducted a prospective, multicenter, single-blind, randomized controlled phase II trial involving patients with severe coronavirus disease 2019.
RESULTS


Forty-three patients were randomly assigned (1:1) to receive ruxolitinib plus standard-of-care treatment (22 patients) or placebo based on standard-of-care treatment (21 patients). After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in the intervention group and 21 patients in the control group were included in the study. Treatment with ruxolitinib plus standard-of-care was not associated with significantly accelerated clinical improvement in severe patients with coronavirus disease 2019, although ruxolitinib recipients had a numerically faster clinical improvement. Eighteen (90%) patients from the ruxolitinib group showed computed tomography improvement at day 14 compared with 13 (61.9%) patients from the control group (P = .0495). Three patients in the control group died of respiratory failure, with 14.3% overall mortality at day 28; no patients died in the ruxolitinib group. Ruxolitinib was well tolerated with low toxicities and no new safety signals. Levels of 7 cytokines were significantly decreased in the ruxolitinib group in comparison to the control group.
CONCLUSIONS


Although no statistical difference was observed, ruxolitinib recipients had a numerically faster clinical improvement. Significant chest computed tomography improvement, a faster recovery from lymphopenia, and favorable side-effect profile in the ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.",2020,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","['severe coronavirus disease 2019 (COVID-19', 'patients with severe COVID-19', 'Forty-three patients']","['ruxolitinib plus SoC', 'placebo based on SoC treatment', 'ruxolitinib plus SoC treatment']","['tolerated with low toxicities and no new safety signals', 'overall mortality', 'died of respiratory failure', 'CT improvement', 'Levels of 7 cytokines']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",43.0,0.116984,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, Wuhan, China.'}, {'ForeName': 'Tiebin', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Gaoxiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Fankai', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Mao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jungang', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Site of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, Wuhan, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Site of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Divisions of Pathology and Experimental Hematology and Cancer Biology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. Electronic address: Gang.Huang@cchmc.org.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: wwang@vip.126.com.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Clincal Trial and Research Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: jfzhou@tjh.tjmu.edu.cn.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.05.019']
1334,32482999,Ephedrine versus Phenylephrine Effect on Cerebral Blood Flow and Oxygen Consumption in Anesthetized Brain Tumor Patients: A Randomized Clinical Trial.,"BACKGROUND


Studies in anesthetized patients suggest that phenylephrine reduces regional cerebral oxygen saturation compared with ephedrine. The present study aimed to quantify the effects of phenylephrine and ephedrine on cerebral blood flow and cerebral metabolic rate of oxygen in brain tumor patients. The authors hypothesized that phenylephrine reduces cerebral metabolic rate of oxygen in selected brain regions compared with ephedrine.
METHODS


In this double-blinded, randomized clinical trial, 24 anesthetized patients with brain tumors were randomly assigned to ephedrine or phenylephrine treatment. Positron emission tomography measurements of cerebral blood flow and cerebral metabolic rate of oxygen in peritumoral and normal contralateral regions were performed before and during vasopressor infusion. The primary endpoint was between-group difference in cerebral metabolic rate of oxygen. Secondary endpoints included changes in cerebral blood flow, oxygen extraction fraction, and regional cerebral oxygen saturation.
RESULTS


Peritumoral mean ± SD cerebral metabolic rate of oxygen values before and after vasopressor (ephedrine, 67.0 ± 11.3 and 67.8 ± 25.7 μmol · 100 g · min; phenylephrine, 68.2 ± 15.2 and 67.6 ± 18.0 μmol · 100 g · min) showed no intergroup difference (difference [95% CI], 1.5 [-13.3 to 16.3] μmol · 100 g · min [P = 0.839]). Corresponding contralateral hemisphere cerebral metabolic rate of oxygen values (ephedrine, 90.8 ± 15.9 and 94.6 ± 16.9 μmol · 100 g · min; phenylephrine, 100.8 ± 20.7 and 96.4 ± 17.7 μmol · 100 g · min) showed no intergroup difference (difference [95% CI], 8.2 [-2.0 to 18.5] μmol · 100 g · min [P = 0.118]). Ephedrine significantly increased cerebral blood flow (difference [95% CI], 3.9 [0.7 to 7.0] ml · 100 g · min [P = 0.019]) and regional cerebral oxygen saturation (difference [95% CI], 4 [1 to 8]% [P = 0.024]) in the contralateral hemisphere compared to phenylephrine. The change in oxygen extraction fraction in both regions (peritumoral difference [95% CI], -0.6 [-14.7 to 13.6]% [P = 0.934]; contralateral hemisphere difference [95% CI], -0.1 [- 12.1 to 12.0]% [P = 0.989]) were comparable between groups.
CONCLUSIONS


The cerebral metabolic rate of oxygen changes in peritumoral and normal contralateral regions were similar between ephedrine- and phenylephrine-treated patients. In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine.",2020,"In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine.","['Anesthetized Brain Tumor Patients', 'brain tumor patients', '24 anesthetized patients with brain tumors', 'anesthetized patients without cerebral pathology', 'adult patients with brain tumors', 'anesthetized patients']","['ephedrine- and phenylephrine', 'ephedrine or phenylepherine', 'phenylephrine and ephedrine', 'phenylephrine', 'ephedrine or phenylephrine', 'Phenylephrine', 'ephedrine', 'Ephedrine']","['cerebral metabolic rate of oxygen', 'Peritumoral mean ± SD cerebral metabolic rate of oxygen values', 'Corresponding contralateral hemisphere cerebral metabolic rate of oxygen values', 'cerebral blood flow and cerebral metabolic rate of oxygen', 'cerebral blood flow and regional cerebral oxygen saturation', 'change in oxygen extraction fraction', 'Positron emission tomography measurements of cerebral blood flow and cerebral metabolic rate of oxygen', 'contralateral hemisphere difference', 'Cerebral Blood Flow and Oxygen Consumption', 'cerebral blood flow', 'regional cerebral oxygen saturation', 'cerebral metabolic rate of oxygen changes', 'changes in cerebral blood flow, oxygen extraction fraction, and regional cerebral oxygen saturation']","[{'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0014479', 'cui_str': 'Ephedrine'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",24.0,0.583823,"In the normal contralateral region, ephedrine was associated with an increase in cerebral blood flow and regional cerebral oxygen saturation compared with phenylephrine.","[{'ForeName': 'Klaus U', 'Initials': 'KU', 'LastName': 'Koch', 'Affiliation': 'From the Department of Anesthesiology, Section of Neuroanesthesia (K.U.K., N.J., L.N., M.R.) Department of Nuclear Medicine and PET Center (J.A.) Department of Neurosurgery (G.v.O.) Department of Neuroradiology (L.Ø.), Aarhus University Hospital, Aarhus, Denmark Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus, Denmark (I.K.M., L.Ø.) Department of Anesthesiology, Horsens Regional Hospital, Horsens, Denmark (U.S.E.) Institute of Neuroradiology, Charité, Universitätsmedizin, Berlin, Germany (A.T.).'}, {'ForeName': 'Irene K', 'Initials': 'IK', 'LastName': 'Mikkelsen', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Aanerud', 'Affiliation': ''}, {'ForeName': 'Ulrick S', 'Initials': 'US', 'LastName': 'Espelund', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tietze', 'Affiliation': ''}, {'ForeName': 'Gorm V', 'Initials': 'GV', 'LastName': 'Oettingen', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Juul', 'Affiliation': ''}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nikolajsen', 'Affiliation': ''}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': ''}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003377']
1335,32453224,Employment Status for the First Decade Following Randomization to Cervical Disc Arthroplasty Versus Fusion.,"STUDY DESIGN


An analysis of employment status data up to 10 years following the Federal Drug Administration (FDA) Investigational Device Exemption (IDE) randomized trial and extension as post-approval study comparing BRYAN cervical disc (Medtronic, Minneapolis, MN) arthroplasty (CDA) versus single-level anterior cervical discectomy and fusion (ACDF) was performed.
OBJECTIVE


Ten-year experience with the BRYAN disc arthroplasty trial provides opportunity to report patient employment data.
SUMMARY OF BACKGROUND DATA


The long-term consequences of arthroplasty remain incomplete, including the occurrence of occupational compromise.
METHODS


Patients' employment status were measured at regular intervals in both groups up to 10 years.
RESULTS


The preoperative employment status proportion was comparable between investigational (BRYAN CDA) and control (ACDF) groups. In the investigational group, 49.2% returned to work at 6 weeks compared with 39.4% of the control group (P = 0.046). At 6 months and 2 years postoperatively, there was a similar likelihood of active employment in both groups. After 2 years at all time points, 10% drop-off seen in control group employment, but not in investigational group. At 10 years, 76.2% CDA patients were employed to 64.1% ACDF patients (P = 0.057). Preoperative variables influencing work status at 10 years following CDA included: preoperative work status, age, and SF-36 Mental Component Score (SF-36 MCS); whereas, no significant preoperative factor identified with ACDF. Time to return to work was influenced in both groups by preoperative work status; and in the ACDF group: reaching age 65 at 10-year visit, preoperative arm pain and NDI score had significant influences.
CONCLUSION


More patients returned to work at 6 weeks after CDA compared with ACDF, although there was no difference by 6 months. After 2 years, a nonsignificant trend toward higher employment rates in the arthroplasty group was evident, but this difference could not be validated due to the very high rate of loss of patients to the follow-up.
LEVEL OF EVIDENCE


2.",2020,The preoperative employment status proportion was comparable between investigational (BRYAN CDA) and control (ACDF) groups.,['Patients employment status were measured at regular intervals in both groups up to10 years'],"['Cervical Disc Arthroplasty versus Fusion', 'cervical disc arthroplasty (CDA) versus single-level anterior cervical discectomy and fusion (ACDF']","['preoperative employment status proportion', 'employment rates', 'active employment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0242271', 'cui_str': 'Employment status'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",,0.0380675,The preoperative employment status proportion was comparable between investigational (BRYAN CDA) and control (ACDF) groups.,"[{'ForeName': 'Siddharth A', 'Initials': 'SA', 'LastName': 'Badve', 'Affiliation': 'Attending Spine Surgeon and Orthopedic Faculty, Geisenger Health System, Lewistown Hospital, Lewistown, PA.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Florman', 'Affiliation': 'Neurological Surgery, Maine Medical Center, Scarborough, ME.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Levi', 'Affiliation': 'Department of Neurological Surgery, Miller School of Medicine, University of Miami, Miami, FL.'}, {'ForeName': 'Swamy', 'Initials': 'S', 'LastName': 'Kurra', 'Affiliation': 'Department of Orthopedic Surgery, SUNY Upstate Medical University, Syracuse, NY.'}, {'ForeName': 'K Daniel', 'Initials': 'KD', 'LastName': 'Riew', 'Affiliation': 'Orthopedic Surgery, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Lavelle', 'Affiliation': 'Department of Orthopedic Surgery, SUNY Upstate Medical University, Syracuse, NY.'}]",Spine,['10.1097/BRS.0000000000003565']
1336,32451615,Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study.,"OBJECTIVE


SELECTED, an open-label extension study, evaluated daclizumab beta treatment for up to 6 years in participants with relapsing multiple sclerosis who completed the randomized SELECT/SELECTION studies. We report final results of SELECTED.
METHODS


Eligible participants who completed 1-2 years of daclizumab beta treatment in SELECT/SELECTION received daclizumab beta 150 mg subcutaneously every 4 weeks for up to 6 years in SELECTED. Safety assessments were evaluated for the SELECTED treatment period; efficacy data were evaluated from first dose of daclizumab beta in SELECT/SELECTION.
RESULTS


Ninety percent (410/455) of participants who completed treatment in SELECTION enrolled in SELECTED. Within SELECTED, 69% of participants received daclizumab beta for > 3 years, 39% for > 4 years, and 9% for > 5 years; 87% of participants experienced an adverse event and 26% a serious adverse event (excluding multiple sclerosis relapse). No deaths occurred. Overall, hepatic events were reported in 25% of participants; serious hepatic events in 2%. There were no confirmed cases of immune-mediated encephalitis. Based on weeks from the first daclizumab beta dose in SELECT/SELECTION, adjusted annualized relapse rate (95% confidence interval) for weeks 0-24 was 0.21 (0.16-0.29) and remained low on continued treatment. Overall incidence of 24-week confirmed disability progression was 17.4%. Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time.
CONCLUSIONS


The effects of daclizumab beta on clinical and radiologic outcomes were sustained for up to ~ 8 years of treatment. No new safety concerns were identified in SELECTED.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01051349; first registered on January 15, 2010.",2020,"Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time.
","['up to 6\xa0years in participants with relapsing multiple sclerosis', 'Ninety percent (410/455) of participants who completed treatment', 'relapsing-remitting multiple sclerosis', 'Eligible participants who completed 1-2\xa0years of daclizumab beta treatment in SELECT/SELECTION received']","['daclizumab beta for ', 'daclizumab beta 150\xa0mg subcutaneously every 4\xa0weeks', 'daclizumab', 'daclizumab beta treatment', 'daclizumab beta']","['annualized relapse rate', 'serious adverse event (excluding multiple sclerosis relapse', 'serious hepatic events', 'clinical and radiologic outcomes', 'Overall incidence of 24-week confirmed disability progression', 'brain volume', 'Overall, hepatic events', 'immune-mediated encephalitis']","[{'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0014038', 'cui_str': 'Encephalitis'}]",,0.0418529,"Mean numbers of new/newly enlarging T2 hyperintense lesions remained low; percentage change in whole brain volume decreased over time.
","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gold', 'Affiliation': 'St. Josef-Hospital/Ruhr-University Bochum, 44791, Bochum, Germany. ralf.gold@rub.de.'}, {'ForeName': 'Ernst-Wilhelm', 'Initials': 'EW', 'LastName': 'Radue', 'Affiliation': 'Medical Image Analysis Center, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Selmaj', 'Affiliation': 'Department of Neurology, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Eva Kubala', 'Initials': 'EK', 'LastName': 'Havrdova', 'Affiliation': 'Department of Neurology, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Hospital Vall d'Hebron University, Barcelona, Spain.""}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Stefoski', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'DKD Helios Klinik Wiesbaden, Wiesbaden, Germany.'}, {'ForeName': 'Randy R', 'Initials': 'RR', 'LastName': 'Robinson', 'Affiliation': 'AbbVie Inc., Redwood City, CA, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Fam', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Biogen, Maidenhead, UK.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Chalkias', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giannattasio', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Lima', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Castro-Borrero', 'Affiliation': 'Biogen, Cambridge, MA, USA.'}]",Journal of neurology,['10.1007/s00415-020-09835-y']
1337,32460315,Defocus Incorporated Multiple Segments Spectacle Lenses Changed the Relative Peripheral Refraction: A 2-Year Randomized Clinical Trial.,"Purpose


To compare changes in relative peripheral refraction (RPR) associated with myopia progression in myopic children wearing Defocus Incorporated Multiple Segments (DIMS) lenses and single vision (SV) spectacle lenses over 2 years.
Methods


A 2-year double-blind, randomized controlled trial was conducted on 183 myopic children. Subjects were allocated to either wearing DIMS (n = 93) or SV spectacle lenses (n = 90). Peripheral refraction at 10°, 20°, and 30° of the nasal (10N, 20N, 30N) and temporal (10T, 20T, 30T) retinal eccentricities, central refraction, and axial length after cycloplegia were monitored every 6 months.
Results


DIMS group showed symmetrical peripheral myopic shifts between the nasal and temporal retina (comparing myopic shifts between the nasal and temporal retina, the difference between the corresponding eccentricities were nonclinically significance). SV group showed asymmetrical peripheral myopic shifts between the nasal and temporal retina, with more myopic shifts (all P ≤ 0.001) at 10T (-0.32 ± 0.62 diopters [D]), at 20T (-0.69 ± 0.95 D), and 30T (-0.85 ± 1.52 D). No significant changes in RPR spherical equivalent (M) were noted in the DIMS group, whereas significant increases (all P < 0.0001) in hyperopic RPR M were observed at 10N (0.27 ± 0.45 D), 20N (0.75 ± 0.72 D), and 30N (0.98 ± 0.76 D) in the SV group.
Conclusions


Wearing DIMS lenses resulted in a significantly different peripheral refraction profile and RPR changes, as well as significant myopia control effects when compared with SV lenses. Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.",2020,"Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.","['183 myopic children', 'myopic children wearing Defocus Incorporated']","['Multiple Segments (DIMS) lenses and single vision (SV) spectacle lenses', 'wearing DIMS', 'SV spectacle lenses']","['symmetrical peripheral myopic shifts', '30T) retinal eccentricities, central refraction, and axial length after cycloplegia', 'RPR spherical equivalent (M', 'peripheral refraction and slowed central myopia progression', 'hyperopic RPR M', 'relative peripheral refraction (RPR', 'Peripheral refraction', 'peripheral refraction profile and RPR changes', 'asymmetrical peripheral myopic shifts', 'Relative Peripheral Refraction', 'myopia control effects']","[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0181607', 'cui_str': 'Spectacle lens'}, {'cui': 'C1275648', 'cui_str': 'Single vision glasses'}]","[{'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0235238', 'cui_str': 'Cycloplegia'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",183.0,0.154496,"Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.","[{'ForeName': 'Han Yu', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': ',.'}, {'ForeName': 'Carly Siu Yin', 'Initials': 'CSY', 'LastName': 'Lam', 'Affiliation': ',.'}, {'ForeName': 'Wing Chun', 'Initials': 'WC', 'LastName': 'Tang', 'Affiliation': ',.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Leung', 'Affiliation': ',.'}, {'ForeName': 'Chi Ho', 'Initials': 'CH', 'LastName': 'To', 'Affiliation': ',.'}]",Investigative ophthalmology & visual science,['10.1167/iovs.61.5.53']
1338,32471729,Efficacy and Safety of Abicipar in Neovascular Age-Related Macular Degeneration: 52-Week Results of Phase 3 Randomized Controlled Study.,"PURPOSE


To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naïve patients with neovascular age-related macular degeneration (AMD).
DESIGN


Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis.
PARTICIPANTS


Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled.
METHODS


Patients (n = 1888) were randomized in a 1:1:1 ratio to study eye treatment with abicipar 2 mg every 8 weeks after 3 initial doses at baseline and weeks 4 and 8 (Q8), abicipar 2 mg every 12 weeks after 3 initial doses at baseline and weeks 4 and 12 (Q12), or ranibizumab 0.5 mg every 4 weeks (Q4).
MAIN OUTCOME MEASURES


The primary efficacy end point was proportion of patients with stable vision (defined as <15-letter loss in BCVA from baseline) in the study eye at week 52. Secondary end points included change from baseline in BCVA and central retinal thickness (CRT) at week 52. Safety measures included adverse events (AEs).
RESULTS


The proportion of patients with stable vision at week 52 was 93.2%, 91.3%, and 95.8% in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively, with both abicipar Q8 and Q12 noninferior to ranibizumab Q4. Week 52 mean change from baseline in BCVA was 7.5, 6.4, and 8.4 letters and in CRT was -144, -145, and -144 μm in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids.
CONCLUSIONS


Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment.",2020,"CONCLUSIONS


Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52.","['Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled', 'Neovascular Age-Related Macular Degeneration', '1888', 'Patients (n\xa0', 'naïve patients with neovascular age-related macular degeneration (AMD']","['topical corticosteroids', 'oral and/or injectable corticosteroids', 'Abicipar', 'ranibizumab 0.5 mg every 4 weeks (Q4', 'ranibizumab']","['Intraocular inflammation', 'change from baseline in BCVA and central retinal thickness (CRT', 'Efficacy and Safety', 'Incidence of intraocular inflammation (IOI) AEs', 'proportion of patients with stable vision', 'efficacy and safety', 'adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0024437', 'cui_str': 'Degenerative disorder of macula'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}]","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",1888.0,0.237033,"CONCLUSIONS


Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52.","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Kunimoto', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona. Electronic address: derek_kunimoto@yahoo.com.'}, {'ForeName': 'Young Hee', 'Initials': 'YH', 'LastName': 'Yoon', 'Affiliation': 'Asan Medical Center, University of Ulsan, Seoul, South Korea.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Sydney Retina Clinic, Sydney, Australia; Save Sight Institute, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California.'}, {'ForeName': 'Raj K', 'Initials': 'RK', 'LastName': 'Maturi', 'Affiliation': 'Midwest Eye Institute, Indianapolis, Indiana; Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Hansjürgen', 'Initials': 'H', 'LastName': 'Agostini', 'Affiliation': 'Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Souied', 'Affiliation': ""Centre Hospitalier Creteil, Service Universitaire d'Ophthalmologie, Creteil, France.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Chow', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Ontario, Canada; Toronto Retina Institute, North York, Ontario, Canada.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Lotery', 'Affiliation': 'University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ohji', 'Affiliation': 'Department of Ophthalmology, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bandello', 'Affiliation': 'University Vita-Salute Scientific Institute, Hospital San Raffaele, Milan, Italy.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort', 'Affiliation': 'Vision Institute, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Le', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schmidt', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': 'Yehia', 'Initials': 'Y', 'LastName': 'Hashad', 'Affiliation': 'Allergan plc, Irvine, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.035']
1339,32476640,"Effects of the  Rango Cards  game intervention on food consumption, nutritional knowledge and self-efficacy in the adoption of healthy eating practices of high school students: a cluster randomised controlled trial.","OBJECTIVE


The study aimed to assess the impact of a game-based nutritional intervention on food consumption, nutritional knowledge and self-efficacy in the adoption of healthy eating practices.
DESIGN


This cluster randomised controlled trial included both male and female high school students from private schools in the Federal District, Brazil. Four schools were randomly selected for each group. Investigated variables were age, sex, monthly family income, maternal education level, dietary perceptions and practices, nutritional knowledge and self-efficacy in the adoption of healthy eating practices.
SETTING


Intervention group participants were instructed to play Rango Cards, a digital game developed for the study, on their own, for a period of 7-17 d, while the control group was not provided with any game or material during the study.
PARTICIPANTS


The study included 319 adolescents (mean age = 15·8 (sd 0·7) years).
RESULTS


Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants. The intervention group showed increased knowledge of the effects of fruit and vegetable consumption as well as improved self-efficacy in the adoption of healthy eating practices such as reducing Na intake and preparing healthy meals.
CONCLUSIONS


The design of Rango Cards is potentially capable of effecting positive changes. Therefore, the digital game promotes autonomy and self-care among adolescents with regard to healthy eating.",2020,"RESULTS


Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants.","['The study included 319 adolescents (mean age = 15·8', 'healthy eating practices', 'adolescents with regard to healthy eating', 'healthy eating practices of high school students', 'male and female high school students from private schools in the Federal District, Brazil']","['play Rango Cards, a digital game', 'game-based nutritional intervention', 'Rango Cards  game intervention']","['knowledge of the effects of fruit and vegetable consumption', 'food consumption, nutritional knowledge and self-efficacy', 'self-efficacy']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0567466', 'cui_str': 'Eating practice'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",319.0,0.0509513,"RESULTS


Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants.","[{'ForeName': 'Carolina Martins Dos Santos', 'Initials': 'CMDS', 'LastName': 'Chagas', 'Affiliation': 'Federal University of Lavras, Department of Nutrition,\xa0Minas Gerais37200-000, Brazil.'}, {'ForeName': 'Giselle Rhai-Sa', 'Initials': 'GR', 'LastName': 'Melo', 'Affiliation': 'University of Brasilia, School of Health Sciences, Graduate Program in Human Nutrition, Federal District, Brazil.'}, {'ForeName': 'Raquel Braz Assunção', 'Initials': 'RBA', 'LastName': 'Botelho', 'Affiliation': 'University of Brasilia, School of Health Sciences, Post-Graduate Program in Human Nutrition, Federal District, Brazil.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Toral', 'Affiliation': 'University of Brasilia, School of Health Sciences, Post-Graduate Program in Human Nutrition, Federal District, Brazil.'}]",Public health nutrition,['10.1017/S1368980020000531']
1340,32480076,Microstructural white matter changes following gait training with Hybrid Assistive Limb initiated within 1 week of stroke onset.,"The early initiation of robot-assisted gait training in patients with acute stroke could promote neuroplasticity. The aim of this study was to clarify the microstructural changes of white matter associated with gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI). Patients with first-ever stroke and requiring a walking aid started gait training within 1 week of stroke onset. The patients were quasi-randomly assigned either to the conventional physical therapy (CPT) group or gait training using HAL (HAL) group. Motor function and DTI were examined at baseline and after 3-5 months. Voxel-based statistical analyses of fractional anisotropy (FA) images were performed using diffusion metric voxel-wise analyses. Volume of interest (VOI)-based analyses were used to assess changes in FA (ΔFA). Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study. There were improvements in motor function and independency in the CPT and HAL groups (p < .001). Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001). Gait training using HAL initiated within 1 week after stroke onset facilitated the recovery of inter-hemispheric communication and prevented the progression of Wallerian degeneration of the affected pyramidal tract.",2020,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","['Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study', 'Patients with first-ever stroke and requiring a walking aid started gait training within 1\xa0week of stroke onset', 'patients with acute stroke']","['Gait training using HAL', 'gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI', 'robot-assisted gait training', 'conventional physical therapy (CPT) group or gait training using HAL (HAL', 'gait training with Hybrid Assistive Limb']","['Motor function and DTI', 'changes in FA (ΔFA', 'contra-lesional rostrum of the corpus callosum', 'motor function and independency', 'FA in the ipsi-lesional cerebral peduncle']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0152322', 'cui_str': 'Structure of rostrum of corpus callosum'}, {'cui': 'C0007793', 'cui_str': 'Cerebral peduncle structure'}]",27.0,0.0293157,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ando', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Yokota', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan; Department of Stroke Rehabilitation, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: cyokota@ncvc.go.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Koshino', 'Affiliation': 'Department of Systems and Informatics, Hokkaido Information University, Ebetsu, Japan. Electronic address: koshino@do-johodai.ac.jp.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Yasuno', 'Affiliation': 'Department of Psychiatry, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan. Electronic address: yasunof@ncgg.go.jp.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Akihide', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Industrial-Academic Collaboration, Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: ayamamot@ncvc.go.jp.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Odani', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Department of Neurology, National Hospital Organization Niigata National Hospital, Kashiwazaki, Japan. Electronic address: nakajima.takashi.ud@mail.hosp.go.jp.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Nuclear Medicine and Comprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Tatsumi', 'Affiliation': 'Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: tatsumi@ncvc.go.jp.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116939']
1341,32585338,Targeting T cells in inflammatory bowel disease.,"T cells play a pivotal role in the immune response underlying inflammatory bowel disease (IBD) pathogenesis. On this basis, over the past 25 years several drugs have assessed to target T cells in IBD patients. Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only. The anti-CD4 BF-5 and cM-T412, and the anti-CD25 basiliximab and daclizumab were not effective in CD and UC patients, respectively. The anti-NKG2D antibody NNC0142-0002 showed clinical benefit in CD patients, in particular in biologic naïve ones, in a randomized, double-blind, parallel-group, placebo-controlled trial. The anti-CD40L M90 and the GSK1349571A blocking calcium release-activated calcium (CRAC) channels, which are involved in the T cell activation and proliferation, were tested only in ex vivo/in vitro experiments. Apart from ustekinumab, all the other drugs targeting T cell-derived cytokines failed. The reinduction of lamina propria T cell apoptosis is a mechanism to modulate T cell survival exploited by cyclosporin A, azathioprine and anti-tumor necrosis factor-α agents, such as infliximab, adalimumab and golimumab. In this article, we review the drugs targeting T cells via surface receptors, via T cell-derived cytokines, via CRAC channels or by inducing apoptosis.",2020,"Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only.","[""ulcerative colitis (UC) and Crohn's disease (CD) patients""]","['cyclosporin A, azathioprine', 'daclizumab', 'placebo']",[],"[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0961703,"Amongst anti-CD3 antibodies, visilizumab and foralumab did not show clinical efficacy in ulcerative colitis (UC) and Crohn's disease (CD) patients, respectively, whereas otelixizumab has been tested in vitro only.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giuffrida', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Sabatino', 'Affiliation': 'First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy. Electronic address: a.disabatino@smatteo.pv.it.'}]",Pharmacological research,['10.1016/j.phrs.2020.105040']
1342,32585438,Effect of in-bed cycling on acute muscle wasting in critically ill adults: A randomised clinical trial.,"PURPOSE


To examine whether in-bed cycling assists critically ill adults to reduce acute muscle wasting, improve function and improve quality of life following a period of critical illness.
MATERIALS AND METHODS


A single-centre, two-group, randomised controlled trial with blinded assessment of the primary outcome was conducted in a tertiary ICU. Critically ill patients expected to be mechanically ventilated for at least 48 h were randomised to 30 min daily in-bed cycling in addition to usual-care physiotherapy (n = 37) or usual-care physiotherapy (n = 37). The primary outcome was muscle atrophy of rectus femoris cross-sectional area (RF CSA ) measured by ultrasound at Day 10 following study enrolment. Secondary outcomes included manual muscle strength, handgrip strength, ICU mobility score, six-minute walk test distance and health-related quality of life up to six-months following hospital admission.
RESULTS


Analysis included the 72 participants (mean age, 56-years; male, 68%) who completed the study. There were no significant between-group differences in muscle atrophy of RF CSA  at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95).
CONCLUSIONS AND RELEVANCE


In-bed cycling did not reduce muscle wasting in critically ill adults, but this study provides useful effect estimates for large-scale clinical trials.
TRIAL REGISTRATION


anzctr.org.au Identifier: ACTRN12616000948493.",2020,"There were no significant between-group differences in muscle atrophy of RF CSA  at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95).
","['72 participants (mean age, 56-years; male, 68%) who completed the study', 'critically ill adults', 'Critically ill patients expected to be mechanically ventilated for at least 48\xa0h']","['anzctr.org.au Identifier', '30\xa0min daily in-bed cycling in addition to usual-care physiotherapy (n\xa0=\xa037) or usual-care physiotherapy', 'bed cycling']","['quality of life', 'manual muscle strength, handgrip strength, ICU mobility score, six-minute walk test distance and health-related quality of life up to six-months following hospital admission', 'muscle atrophy of rectus femoris cross-sectional area (RF CSA ', 'muscle atrophy of RF CSA']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}]",,0.450536,"There were no significant between-group differences in muscle atrophy of RF CSA  at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95).
","[{'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Nickels', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: marc.nickels@health.qld.gov.au.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Aitken', 'Affiliation': 'School of Health Sciences, City, University of London, London, United Kingdom; Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia. Electronic address: leanne.aitken.1@city.ac.uk.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia. Electronic address: a.barnett@qut.edu.au.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Walsham', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: james.walsham@health.qld.gov.au.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'King', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: scott.king@health.qld.gov.au.'}, {'ForeName': 'Nicolette E', 'Initials': 'NE', 'LastName': 'Gale', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: nicolette.gale@health.qld.gov.au.'}, {'ForeName': 'Alicia C', 'Initials': 'AC', 'LastName': 'Bowen', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: alicia.bowen@health.qld.gov.au.'}, {'ForeName': 'Brent M', 'Initials': 'BM', 'LastName': 'Peel', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: brent.peel@health.qld.gov.au.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Donaldson', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: samuel.donaldson2@health.qld.gov.au.'}, {'ForeName': 'Stewart T J', 'Initials': 'STJ', 'LastName': 'Mealing', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: stewart.mealing@health.qld.gov.au.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Clinical Informatics, Metro South Health, Brisbane, Australia. Electronic address: steven.mcphail@qut.edu.au.'}]",Journal of critical care,['10.1016/j.jcrc.2020.05.008']
1343,32588071,Invited Discussion on: Evaluation of the Sensitivity of the Nipple-Areola Complex in Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release: A Randomized Controlled Trial.,,2020,,['Patients Undergoing Breast Ptosis Correction with Periareolar Dermis Release'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0005745', 'cui_str': 'Ptosis of eyelid'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",[],[],,0.0915365,,"[{'ForeName': 'Maurice Y', 'Initials': 'MY', 'LastName': 'Nahabedian', 'Affiliation': 'Virginia Commonwealth University, Inova Branch, National Center for Plastic Surgery, 7601 Lewinsville Dr., #400, McLean, VA, 22102, USA. DrNahabedian@aol.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01839-3']
1344,32588891,Risk of Secondary Traumatic Stress in Treating Traumatized Military Populations: Results from the PTSD Clinicians Exchange.,"INTRODUCTION


This study examined risk factors for secondary traumatic stress (STS) in behavioral health clinicians and whether access to the Post-Traumatic Stress Disorder (PTSD) Clinicians Exchange website mitigated STS risk.
METHODS


A diverse sample of clinicians (N = 605) treating traumatized military populations in Department of Veterans Affairs (VA), Department of Defense, and community practice settings were randomized to a newsletter-only control group or the exchange group. The exchange website included resources for treating PTSD and promoting clinician well-being. Online surveys were administered at 0-, 6-, and 12-months postrandomization. Regression analyses were used to examine the link among risk factors, exchange access, and STS.
RESULTS


Baseline clinician demographics, experience, total caseload, appeal of evidence-based practices (EBPs), and likelihood of adopting EBPs if required were not linked with STS at the 12-month assessment period. Providing care at the VA, more burnout, less compassion satisfaction, greater trauma caseload, less openness to new EBPs, and greater divergence from EBP procedures were linked with greater STS. Only burnout and divergence were associated with STS after accounting for other significant STS risk factors. Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence.
CONCLUSIONS


Given that burnout was linked with STS, future intervention may use techniques targeting burnout and STS (eg, emotion regulation strategies). Research exploring the link between divergence from EBPs and STS may inform EBP dissemination efforts and STS interventions. Finally, results highlight the need for research optimizing STS intervention efficacy among clinicians treating military populations.",2020,"Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence.
","['Treating Traumatized Military Populations', 'A diverse sample of clinicians (N\xa0=\xa0605) treating traumatized military populations in Department of Veterans Affairs (VA), Department of Defense, and community practice settings']",[],"['Baseline clinician demographics, experience, total caseload, appeal of evidence-based practices (EBPs), and likelihood of adopting EBPs', 'STS levels']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",605.0,0.0367443,"Exchange and control group clinicians reported similar STS levels after accounting for burnout and divergence.
","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Penix', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Clarke-Walper', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Magnavita', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Simon', 'Affiliation': 'Palo Alto Veterans Institute for Research, 3801 Miranda Avenue, Palo Alto, CA 94304.'}, {'ForeName': 'Kile', 'Initials': 'K', 'LastName': 'Ortigo', 'Affiliation': 'Dissemination and Training Division, National Center for PTSD, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Marceau', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Josef I', 'Initials': 'JI', 'LastName': 'Ruzek', 'Affiliation': 'Dissemination and Training Division, National Center for PTSD, 795 Willow Road, Menlo Park, CA 94025.'}, {'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Rosen', 'Affiliation': 'New England Research Institutes, Inc., 480 Pleasant Street, Watertown, MA 02472.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'Wilk', 'Affiliation': 'Military Psychiatry Branch, Walter Reed Army Institute of Research, 503 Robert Grant Avenue, Silver Spring, MD 20910.'}]",Military medicine,['10.1093/milmed/usaa078']
1345,32456618,"Effectiveness of mobile SMS based counselling intervention in improving the knowledge, attitude, and practices of HIV/AIDS patients enrolled in hospitals/NGOs in Terengganu, Malaysia: a mixed mode study protocol.","BACKGROUND


HIV/AIDS is one of the most serious problems in many parts of the world, and is a high priority for health managers and decision-makers. The aim of the qualitative part of this study will be to develop a mobile SMS (short messaging services) counselling intervention to prevent HIV/AIDS, while the quantitative part will be to test the effectiveness of a mobile SMS counselling intervention to improve the knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS.
METHOD


A mixed methods approach will be used. Qualitative part: Design: focus group discussions (FGDs) will be conducted.
SETTING


Hospital/NGOs in Terengganu, Malaysia.
PARTICIPANTS


Three FGDs will be conducted with male and female HIV/AIDS patients, and one group of local community leaders. One FGD will be conducted for each group. Three in-depth interviews (IDIs) will be conducted with patients who had HIV/AIDS, of which one will be female. Quantitative part: Design: a cluster randomized clinical trial with 384 HIV/AIDS patients in Terengganu, Malaysia.
INTERVENTION


Mobile SMS counselling intervention for patients concerning the prevention of HIV/AIDS.
RESULTS


The main outcomes of this study will be the differences in knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS between the baseline and immediate follow-up after the intervention, and after 3 months.
CONCLUSIONS


The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia.
TRIAL REGISTRATION


Thai Clinical Trials Registry, TCTR20200212001; 7/02/2020.",2020,"The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia.
","['Three FGDs will be conducted with male and female HIV/AIDS patients, and one group of local community leaders', '384 HIV/AIDS patients in Terengganu, Malaysia', 'Hospital/NGOs in Terengganu, Malaysia', 'HIV/AIDS patients enrolled in hospitals/NGOs in Terengganu, Malaysia', 'patients who had HIV/AIDS, of which one will be female']","['mobile based SMS counselling intervention', 'mobile SMS based counselling intervention', 'Mobile SMS counselling intervention', 'mobile SMS counselling intervention']","['knowledge, attitude, and practices of patients concerning the prevention of HIV/AIDS']","[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]",384.0,0.220058,"The mobile based SMS counselling intervention developed will be effective in improving the knowledge, attitude, and practices of patients concerning HIV/AIDS prevention in Terengganu, Malaysia.
","[{'ForeName': 'Md Mosharaf', 'Initials': 'MM', 'LastName': 'Hossain', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia. md.hossain@umt.edu.my.'}, {'ForeName': 'Ruhani Binti Mat', 'Initials': 'RBM', 'LastName': 'Min', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia.'}, {'ForeName': 'Zikri', 'Initials': 'Z', 'LastName': 'Muhammad', 'Affiliation': 'Faculty of Business, Economics & Social Development, University Malaysia Terengganu, 21030, Kuala Terengganu, Malaysia.'}, {'ForeName': 'Kulanthayan K C', 'Initials': 'KKC', 'LastName': 'Mani', 'Affiliation': 'Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Selangor, Malaysia.'}]",BMC public health,['10.1186/s12889-020-08910-3']
1346,32456804,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP3652, a Reversible Fatty Acid Amide Hydrolase Inhibitor, in Healthy, Nonelderly, Japanese Men and Elderly, Japanese Men and Women: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Phase I Study.","PURPOSE


This study aimed to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic properties of ASP3652, a peripherally acting inhibitor of peripheral fatty acid amide hydrolase (FAAH) after 30-, 100-, 300-, 600-, and 900-mg single and 100- and 300-mg BID multiple oral dose in Japanese patients.
METHODS


This was a randomized, double-blind, placebo-controlled, single and multiple oral dose Phase I study in healthy, nonelderly men and elderly men and women. The study consisted of 2 parts: in the single oral dose part, 40 healthy, nonelderly men were randomized to receive placebo or ASP3652; in the multiple oral dose part, 48 enrolled nonelderly men and elderly men and women were randomized to receive placebo or ASP3652. In both parts, the investigator judged whether the individuals were healthy based on the results of physical examinations and screening. The safety profile was assessed by examining adverse events, defined as any untoward medical occurrence in an individual administered the study drug and that did not necessarily have a causal relationship with the study treatment; clinical laboratory evaluations; vital signs; the Profile of Mood States scale; and standard 12-lead ECGs and 12-lead ECGs for QT assessment. Pharmacokinetic parameters were estimated using unchanged ASP3652 concentrations in plasma and urine. Pharmacodynamic parameters were estimated using FAAH activity and plasma anandamide, oleoylethanolamide, and palmitoylethanolamide concentrations. Safety and tolerability profiles were compared with the placebo group.
FINDINGS


ASP3652 was rapidly absorbed to reach C max  in a single dose and near steady-state at approximately 3 days after the start of multiple dosing. The C max  and AUC of ASP3652 were slightly higher than dose proportional after a single dose of ASP3652 at 30-900 mg. There was no apparent accumulation based on C max  and AUC 0-12  after multiple doses. Although no differences were found in C max  or AUC 0-12  by age in men, C max  and AUC 0-12  were slightly higher in elderly women than elderly men. FAAH activity was inhibited in a dose-dependent manner, and plasma levels of anandamide, oleoylethanolamide, and palmitoylethanolamide increased in all dose groups after single and multiple doses of ASP3652. The incidence of adverse events after multiple doses, which ranged from 44.4% to 66.7%, was similar across all treatment groups, including the placebo group.
IMPLICATIONS


Single and multiple doses of ASP3652 were well tolerated and increased endogenous cannabinoids.",2020,The C max  and AUC of ASP3652 were slightly higher than dose proportional after a single dose of ASP3652 at 30-900 mg.,"['Healthy, Nonelderly, Japanese Men and Elderly, Japanese Men and Women', 'healthy, nonelderly men and elderly men and women', '48 enrolled nonelderly men and elderly men and women', '40 healthy, nonelderly men', 'elderly women than elderly men', 'Japanese patients']","['ASP3652', 'Placebo', 'placebo or ASP3652', 'placebo']","['FAAH activity and plasma anandamide, oleoylethanolamide, and palmitoylethanolamide concentrations', 'FAAH activity', 'safety, tolerability, and pharmacokinetic and pharmacodynamic properties', 'Safety and tolerability profiles', 'plasma levels of anandamide, oleoylethanolamide, and palmitoylethanolamide', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics', 'C max  and AUC of ASP3652', 'incidence of adverse events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0531004', 'cui_str': 'fatty acid amide hydrolase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0211726', 'cui_str': 'anandamide'}, {'cui': 'C1454896', 'cui_str': 'oleoylethanolamide'}, {'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.131241,The C max  and AUC of ASP3652 were slightly higher than dose proportional after a single dose of ASP3652 at 30-900 mg.,"[{'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Takizawa', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan. Electronic address: masaomi.takizawa@astellas.com.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hatta', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Iitsuka', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Katashima', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Astellas Pharma Inc, Ibaraki, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kuroishi', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Nagashima', 'Affiliation': 'Yanagibashi-Clinical Trial Center, Yanagibashi Hospital, Tokyo, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.03.021']
1347,32464351,Efficacy and safety of 5-Hydroxytryptophan on levodopa-induced motor complications in Parkinson's disease: A preliminary finding.,"BACKGROUND AND PURPOSE


Several studies have indicated that altered serotonergic neurotransmission may contribute to the motor features commonly associated with Parkinson's disease (PD) drug treatment such as levodopa-induced dyskinesias (LIDs). 5-Hydroxytryptophan (5-HTP) is the immediate precursor of serotonin. We have recently demonstrated that 5-HTP produces significant antidyskinetic effects in a rat model of PD. To date, there has been inconsistent research on the use of 5-HTP in PD. The purpose of this study was to compare the effects of 5-HTP versus placebo on levodopa-induced motor complications in PD patients.
MATERIAL AND METHODS


A single-center, randomized, double-blind placebo-controlled cross-over study was performed. A total of 12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol. Patients received placebo or 50 mg of 5-HTP daily in a cross-over design over a period of 4 weeks. For the assessment of efficacy on the motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries were obtained at baseline and weeks 4, 8, 12 and 16 (T-end).
RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
CONCLUSIONS


This study provides preliminary evidence of clinical benefit of 5-HTP against LIDs in PD. Larger studies with a longer treatment duration and a wider range of doses are warranted to corroborate these findings.",2020,"RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
","['PD patients', ""Parkinson's disease"", '12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol']","['5-Hydroxytryptophan', '5-HTP versus placebo', '5-Hydroxytryptophan (5-HTP', '5-HTP', 'placebo or 50\xa0mg of 5-HTP', '5-HTP against LIDs', 'placebo']","['UDysRS and UPDRS-IV scores', 'Efficacy and safety', 'motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries', 'LIDs']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.222511,"RESULTS


Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores.
","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Meloni', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. Electronic address: mario.meloni@hotmail.it.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Puligheddu', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Sanna', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Cannas', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Farris', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Tronci', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Figorilli', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Defazio', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Carta', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116869']
1348,32472357,Bioequivalence and Tolerability of Ambrisentan: A Pharmacokinetic Study in Mexican Healthy Male Subjects.,"BACKGROUND


Pulmonary arterial hypertension (PAH) is a disease characterized by a progressive rise in pulmonary vascular resistance. Ambrisentan is an oral, propanoic acid based-endothelin receptor antagonist (ERA), selective for the endothelin type-A receptor, which is approved for the treatment of PAH. The Colombia National Food and Drug Surveillance Institute regulatory criteria require demonstrating that the proposed generic product is bioequivalent to its reference-listed drug to obtain marketing approval.
OBJECTIVES


The purpose of this study was to test the bioequivalence, pharmacokinetics, and tolerability of ambrisentan 10 mg tablets.
METHODS


In this open-label, randomized, oral single-dose, two-way crossover bioequivalence study, 26 Mexican adult healthy male subjects received either the generic product of ambrisentan 10 mg or the reference product Volibris ®  (ambrisentan) 10 mg tablets during each study period under fasting conditions. There was a 7-day washout period between each dosing. Ambrisentan concentrations in plasma samples were quantified using a validated ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method. Blood samples were collected up to 72 h post-dose in each study period. The primary end points were maximum plasma concentration (C max ) and area under the plasma concentration-time (AUC 0-t ) curve between 0 and 72 h for ambrisentan.
RESULTS


The ratios (90% CI) of geometric mean for ambrisentan were 104.3% (97.12-111.98%) and 100.2% (95.56-104.72%). These pharmacokinetic parameter values lie within the INVIMA-specified bioequivalence limits of 80%-125%. Nervous system disorders were the most common adverse events (AEs). All AEs were mild to moderate in nature and were resolved after follow-up or pharmacologic treatment. Both products were safe and well tolerated.
CONCLUSIONS


The test product ambrisentan 10 mg tablets is bioequivalent to the reference product Volibris ®  (ambrisentan) 10 mg tablets. Both treatments were well tolerated in the Mexican male population of this study.
TRIAL REGISTRATION


COFEPRIS National Clinical Trials Registry number 183300410B0367/2018.",2020,Ambrisentan concentrations in plasma samples were quantified using a validated ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method.,"['Mexican male population of this study', 'Mexican Healthy Male Subjects', '26 Mexican adult healthy male subjects']","['Ambrisentan', 'ambrisentan 10\xa0mg tablets', 'generic product of ambrisentan 10\xa0mg or the reference product Volibris ®  (ambrisentan) 10\xa0mg tablets']","['maximum plasma concentration (C max ) and area under the plasma concentration-time (AUC 0-t ) curve', 'bioequivalence, pharmacokinetics, and tolerability', 'geometric mean for ambrisentan', 'safe and well tolerated']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C1949320', 'cui_str': 'ambrisentan 10 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1176329', 'cui_str': 'ambrisentan'}]",26.0,0.0673094,Ambrisentan concentrations in plasma samples were quantified using a validated ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method.,"[{'ForeName': 'Karen Paola Camarillo', 'Initials': 'KPC', 'LastName': 'Cárdenas', 'Affiliation': 'Avant Santé Research Center S.A. de C.V, San Pedro Garza García, Nuevo León, México. kcamarilloc@avantsante.com.'}, {'ForeName': 'Joceline Estefanía Rangel', 'Initials': 'JER', 'LastName': 'Velázquez', 'Affiliation': 'Avant Santé Research Center S.A. de C.V, San Pedro Garza García, Nuevo León, México.'}, {'ForeName': 'Javier Jesús Osorio', 'Initials': 'JJO', 'LastName': 'Escobar', 'Affiliation': 'Avant Santé Research Center S.A. de C.V, San Pedro Garza García, Nuevo León, México.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Chirinos', 'Affiliation': 'Abbott Laboratories de Colombia, Bogotá, Colombia.'}, {'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Pendela', 'Affiliation': 'Avant Santé Research Center S.A. de C.V, San Pedro Garza García, Nuevo León, México.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00627-3']
1349,32473149,Linear Growth between Early and Late Childhood and Cognitive Outcomes at 6-9 Years of Age.,"OBJECTIVES


To assess the extent to which linear growth beyond the early years of life determines later cognitive development.
STUDY DESIGN


We revisited children from New Delhi, India, who had participated in a randomized controlled trial 6 years before and assessed neurodevelopment using standardized and validated psychometric tools (Wechsler Intelligence Scale for Children, 4th edition; Crichton Vocabulary Scales; and Neuropsychological test battery). The associations of change in height for age z scores between early (12-36 months) and late (6-9 years) childhood with cognitive outcomes at 6-9 years of age were explored using linear regression models, after adjustment for appropriate confounders.
RESULTS


Out of the 1000 North Indian children who were enrolled in the original study, 791 consented to participate in this follow-up. Height for age z scores in the first 2 years of life was significantly associated with both the Wechsler Intelligence Scale for Children-Crichton Vocabulary Scales (standardized β coefficient [β], 0.15; 95% CI, 0.08-0.23), and the Neuropsychological test battery-II z-score (β, 0.09; 95% CI, 0.03-0.18) at 6-9 years of age. There were no significant associations between change in height for age z scores between early and later childhood and Wechsler Intelligence Scale for Children-Crichton Vocabulary Scales (β, -0.03; 95% CI, -0.11 to 0.04) or Neuropsychological test battery-II z-scores (β, -0.04; 95% CI, -0.12 to 0.06).
CONCLUSIONS


Linear growth between early and late childhood is not associated with later cognitive outcomes. Our findings support the current practice of investing public health efforts to accelerate linear growth in the first 2-3 years of life.",2020,"There were no significant associations between change in HAZ scores between early and later childhood and WISC-CVS [ẞ -0.03, 95% CI: -0.11 to 0.04] or NEPSY-II z-scores [ẞ -0.04, 95% CI: -0.12 to 0.06].
","['revisited children from New Delhi, India who had participated', '1,000 North Indian children that were enrolled in the original study, 791 consented to participate in this follow-up']",['HAZ'],"['psychometric tools (Wechsler Intelligence Scale for Children 4 th  edition, WISC-IV INDIA ; Crichton Vocabulary Scales, CVS; and Neuropsychological test battery, NEPSY-II', 'HAZ scores', 'Linear Growth between Early and Late Childhood and Cognitive Outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0204457', 'cui_str': 'Wechsler intelligence scale for children'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0451093', 'cui_str': 'Crichton vocabulary scale'}, {'cui': 'C0008509', 'cui_str': 'Sampling of chorionic villus'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0581295,"There were no significant associations between change in HAZ scores between early and later childhood and WISC-CVS [ẞ -0.03, 95% CI: -0.11 to 0.04] or NEPSY-II z-scores [ẞ -0.04, 95% CI: -0.12 to 0.06].
","[{'ForeName': 'Ravi Prakash', 'Initials': 'RP', 'LastName': 'Upadhyay', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India; Centre for International Health, Bergen, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hysing', 'Affiliation': 'Department of Psychosocial Science, Faculty of Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India. Electronic address: sunita.taneja@sas.org.in.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, West, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.'}, {'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Centre for International Health, Bergen, Norway; Department of Research, Innlandet Hospital Trust, Lillehammer, Norway.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.05.043']
1350,32474728,Pharmacokinetics and Safety of Dabigatran Etexilate after Single and Multiple Oral Doses in Healthy Chinese Subjects.,"BACKGROUND AND OBJECTIVE


Dabigatran etexilate is a non-vitamin K antagonist oral anticoagulant (NOAC) that is used to prevent stroke and systemic embolism in adults with nonvalvular atrial fibrillation (NVAF) and one or more risk factors. Pharmacokinetic data on this anticoagulant in Chinese subjects are limited. This study aimed to provide further information on the pharmacokinetic profile of dabigatran in healthy Chinese subjects, together with its safety profile.
METHODS


This was an open-label, single-centre, phase I study. Subjects were randomized into 110 and 150 mg dabigatran etexilate treatment groups. Each subject received 7 days of treatment: a single dose on day 1, no dose on days 2-3, and then multiple doses on days 4-10. Blood samples were collected to analyze the pharmacokinetic profile of dabigatran. All adverse events (AEs) were recorded. Routine clinical laboratory tests, a physical examination, vital signs, and 12-lead electrocardiogram (ECG) measurements were performed.
RESULTS


A total of 28 subjects (14 males and 14 females) were randomized in this trial. The plasma concentration of total dabigatran reached its maximum measured concentration at a median time of 3-4 h from the dose of interest (either the initial single dose on day 1 or the final dose on day 10) under fed conditions, and declined with an elimination half-life of 10.7-10.9 h following the dose of interest. There was a modest difference in pharmacokinetic profile between male and female subjects. None of the subjects experienced a serious adverse event (SAE) or an AE of moderate or severe intensity. The investigator reported that 17 of the 28 subjects had mild treatment-emergent AEs that resolved without any concomitant treatment or intervention. No clinically significant changes in vital signs or ECG parameters were observed.
CONCLUSIONS


This study revealed the pharmacokinetic characteristics and good safety profile of dabigatran in healthy Chinese subjects.",2020,"No clinically significant changes in vital signs or ECG parameters were observed.
","['Chinese subjects', 'Healthy Chinese Subjects', '28 subjects (14 males and 14 females', 'healthy Chinese subjects', 'male and female subjects', 'adults with nonvalvular atrial fibrillation (NVAF']","['vitamin K antagonist oral anticoagulant (NOAC', 'dabigatran etexilate', 'dabigatran', 'Dabigatran Etexilate']","['serious adverse event (SAE) or an AE of moderate or severe intensity', 'plasma concentration of total dabigatran', 'physical examination, vital signs, and 12-lead electrocardiogram (ECG) measurements', 'pharmacokinetic profile', 'vital signs or ECG parameters']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",28.0,0.0820733,"No clinically significant changes in vital signs or ECG parameters were observed.
","[{'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': 'Department of Pharmacy, Peking University Third Hospital, Peking, China. duanjingli@pkuih.edu.cn.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Pharmacy, Peking University Third Hospital, Peking, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular, Peking University Third Hospital, Peking, China.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Yamamura', 'Affiliation': 'Department of Clinical Pharmacokinetics/Pharmacodynamics, Nippon Boehringer Ingelheim Co., Ltd., Kobe, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Harada', 'Affiliation': 'Department of Clinical Pharmacokinetics/Pharmacodynamics, Nippon Boehringer Ingelheim Co., Ltd., Kobe, Japan.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00626-4']
1351,32583295,Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain.,"BACKGROUND AND OBJECTIVE


Opioid-induced respiratory depression (OIRD) is a potentially fatal complication associated with conventional opioids. Currently, there is a paucity of validated endpoints available to measure respiratory safety. Oliceridine, an investigational intravenous (IV) opioid, is a G-protein selective μ-agonist with limited activity on β-arrestin2, a signaling pathway associated with adverse events including OIRD. In controlled phase III trials, oliceridine 0.35 mg and 0.5 mg demand doses demonstrated comparable analgesia to morphine 1 mg with favorable improvements in respiratory safety. In this exploratory analysis, we report dosing interruption (DI) and average cumulative duration of DI (CDDI) for both oliceridine and morphine.
METHODS


Patients requiring analgesia after bunionectomy or abdominoplasty were randomized to IV demand doses of placebo, oliceridine (0.1 mg, 0.35 mg, or 0.5 mg), or morphine (1 mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5 mg, morphine 4 mg, volume-matched placebo) with a 6-min lockout interval. Certified nurse anesthetists monitored each patient and withheld study medication according to the patient's respiratory status. For each patient, the duration of all DIs was summed and reported as CDDI. A zero-inflated gamma mixture model was used to compute the mean CDDI for each treatment.
RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%). The CDDI was also lower across all demand doses of oliceridine versus morphine.
CONCLUSION


Using DI as a surrogate for OIRD indicates improved respiratory safety with oliceridine versus morphine that merits further investigation.",2020,"RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","['Patients requiring analgesia after bunionectomy or abdominoplasty', 'Patients Treated for Acute Postoperative Pain']","['Oliceridine and Morphine', 'oliceridine', 'placebo, oliceridine', 'morphine (1\xa0mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5\xa0mg, morphine 4\xa0mg, volume-matched placebo', 'oliceridine and morphine', 'Oliceridine', 'morphine']","['respiratory safety', 'average cumulative duration of DI (CDDI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",,0.0289906,"RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","[{'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Anesthesiology, Cleveland Clinic, Outcomes Research, Anesthesiology Institute, Fairview Hospital, 18101 Lorain Avenue, Cleveland, OH, 44111, USA. Saayad@ccf.org.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Burt', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Michalsky', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wase', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Clinical drug investigation,['10.1007/s40261-020-00936-0']
1352,32592776,"Highly accurate artificial intelligence systems to predict the invasion depth of gastric cancer: efficacy of conventional white-light imaging, nonmagnifying narrow-band imaging, and indigo-carmine dye contrast imaging.","BACKGROUND AND AIMS


Diagnosing the invasion depth of gastric cancer (GC) is necessary to determine the optimal method of treatment. Although the efficacy of evaluating macroscopic features and EUS has been reported, there is a need for more accurate and objective methods. The primary aim of this study was to test the efficacy of novel artificial intelligence (AI) systems in predicting the invasion depth of GC.
METHODS


A total of 16,557 images from 1084 cases of GC for which endoscopic resection or surgery was performed between January 2013 and June 2019 were extracted. Cases were randomly assigned to training and test datasets at a ratio of 4:1. Through transfer learning leveraging a convolutional neural network architecture, ResNet50, 3 independent AI systems were developed. Each system was trained to predict the invasion depth of GC using conventional white-light imaging (WLI), nonmagnifying narrow-band imaging (NBI), and indigo-carmine dye contrast imaging (Indigo).
RESULTS


The area under the curve of the WLI AI system was .9590. The lesion-based sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of the WLI AI system were 84.4%, 99.4%, 94.5%, 98.5%, and 92.9%, respectively. The lesion-based accuracies of the WLI, NBI, and Indigo AI systems were 94.5%, 94.3%, and 95.5%, respectively, with no significant difference.
CONCLUSIONS


These new AI systems trained with multiple images from different angles and distances could predict the invasion depth of GC with high accuracy. The lesion-based accuracy of the WLI, NBI, and Indigo AI systems was not significantly different.",2020,These new AI systems trained with multiple images from different angles and distances could predict the invasion depth of GC with high accuracy.,['A total of 16557 images from 1084 cases of GC for which endoscopic resection or surgery was performed between January 2013 and June 2019 were extracted'],"['GC using conventional white-light imaging (WLI), nonmagnifying narrow-band imaging (NBI) and indigo-carmine dye contrast imaging (Indigo), respectively', 'novel artificial intelligence systems', 'conventional white-light imaging, nonmagnifying narrow-band imaging, and indigo-carmine dye contrast imaging']","['lesion-based accuracy of the WLI, NBI, and Indigo AI systems', 'lesion-based sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of the WLI AI system']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0021219', 'cui_str': 'indigo carmine'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C3494253', 'cui_str': 'Narrowband Imaging'}, {'cui': 'C0021219', 'cui_str': 'indigo carmine'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",16557.0,0.0451834,These new AI systems trained with multiple images from different angles and distances could predict the invasion depth of GC with high accuracy.,"[{'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Nagao', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Minatsuki', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Niimi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hiroharu', 'Initials': 'H', 'LastName': 'Yamashita', 'Affiliation': 'Department of Gastrointestinal Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Nobutake', 'Initials': 'N', 'LastName': 'Yamamichi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Seto', 'Affiliation': 'Department of Gastrointestinal Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Tada', 'Affiliation': 'Department of Surgical Oncology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; AI Medical Service Inc, Tokyo, Japan; Tada Tomohiro Institute of Gastroenterology and Proctology, Saitama, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Koike', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.06.047']
1353,32593487,Highly Porous Tantalum Acetabular Components Without Ancillary Screws Have Similar Migration to Porous Titanium Acetabular Components With Screws at 2 Years: A Randomized Controlled Trial.,"BACKGROUND


It is proposed that highly porous coatings on acetabular components, such as a porous tantalum coating, provide adequate fixation without ancillary screw fixation in primary total hip arthroplasty (THA). However, tantalum acetabular components have been associated with higher rates of revision than other uncemented components in national registries. The aim of this randomized controlled trial is to determine whether the early migration of a solid-backed tantalum acetabular component was no greater than that of a titanium acetabular component with ancillary screw fixation that has proven good clinical results.
METHODS


Sixty-six patients aged 40 to 64 years, with osteoarthritis and Charnley grade A or B activity grade and who underwent primary THA, were recruited into the trial. Patients were randomized intraoperatively to receive either the tantalum or titanium acetabular component. All patients received the same cemented polished tapered femoral stem, 28-mm cobalt-chromium femoral head, and highly cross-linked polyethylene liner. Acetabular component migration was measured using radiostereometric analysis at 4-6 days postoperatively and at 6 weeks, 3 months, 1 and 2 years following THA.
RESULTS


The mean proximal migration at 2 years for the tantalum cohort was 0.17 mm (95% confidence interval, 0.09-0.24) which was no greater than that of the titanium cohort which was 0.19 mm (0.07-0.32). Harris hip scores and functional activity scores were similar between groups.
CONCLUSION


These results demonstrate that early stability can be achieved without ancillary screw fixation through the use of a highly porous high friction coating on a solid-backed modular acetabular component.
LEVEL OF EVIDENCE


Level I.",2020,"Harris hip scores and functional activity scores were similar between groups.
","['Sixty-six patients aged 40 to 64 years, with osteoarthritis and Charnley grade A or B activity grade and who underwent primary THA, were recruited into the trial']","['same cemented polished tapered femoral stem, 28-mm cobalt-chromium femoral head, and highly cross-linked polyethylene liner', 'Highly Porous Tantalum Acetabular Components', 'titanium acetabular component with ancillary screw fixation', 'tantalum or titanium acetabular component']","['Harris hip scores and functional activity scores', 'Acetabular component migration', 'mean proximal migration']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0039297', 'cui_str': 'Tantalum'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}]",66.0,0.276053,"Harris hip scores and functional activity scores were similar between groups.
","[{'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Howie', 'Affiliation': 'Department of Orthopaedics and Trauma, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Centre for Orthopaedic and Trauma Research, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Oksana T', 'Initials': 'OT', 'LastName': 'Holubowycz', 'Affiliation': 'Centre for Orthopaedic and Trauma Research, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Callary', 'Affiliation': 'Department of Orthopaedics and Trauma, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Centre for Orthopaedic and Trauma Research, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Robertson', 'Affiliation': 'Centre for Orthopaedic and Trauma Research, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lucian B', 'Initials': 'LB', 'LastName': 'Solomon', 'Affiliation': 'Department of Orthopaedics and Trauma, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Centre for Orthopaedic and Trauma Research, The University of Adelaide, Adelaide, South Australia, Australia.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.05.049']
1354,32596251,"A Hydrogel Drink With High Fructose Content Generates Higher Exogenous Carbohydrate Oxidation and Lower Dental Biofilm pH Compared to Two Other, Commercially Available, Carbohydrate Sports Drinks.","The purpose of this study was to evaluate the substrate oxidation of three commercially available, 14%-carbohydrate sports drinks with different compositions, osmolality, and pH for their impact on dental exposure to low pH. In a cross-over, randomized double-blinded design, 12 endurance athletes (age 31. 2 ± 7.7 years,    V   ˙      O 2max  65.6 ± 5.0 mL·kg -1 ) completed 180 min of cycling at 55% W max . During the first 100 min of cycling, athletes consumed amylopectin starch (AP), maltodextrin+sucrose (MD+SUC), or maltodextrin+fructose hydrogel (MD+FRU) drinks providing 95 g carbohydrate·h -1 , followed by water intake only at 120 and 160 min. Fuel use was determined using indirect calorimetry and stable-isotope techniques. Additionally, dental biofilm pH was measured using the microtouch method in a subsample of participants ( n  = 6) during resting conditions before, and at different time intervals up to 45 min following a single bolus of drink. Exogenous carbohydrate oxidation (CHO EXO ) during the 2nd hour of exercise was significantly ( P  < 0.05) different between all three drinks: MD+FRU (1.17 ± 0.17 g·min -1 ), MD+SUC (1.01 ± 0.13 g·min -1 ), and AP (0.84 ± 0.11 g·min -1 ). At the end of exercise, CHO EXO  and blood glucose concentrations (3.54 ± 0.50, 4.07 ± 0.67, and 4.28 ± 0.47 mmol·L -1 , respectively) were significantly lower post MD+FRU consumption than post MD+SUC and AP consumption ( P  < 0.05). Biofilm acidogenicity at rest demonstrated a less pronounced pH fall for MD+FRU compared to the acidulant-containing MD+SUC and AP ( P  < 0.05). In conclusion, while total intake of MD+FRU showed signs of completed uptake before end of monitoring, this was less so for MD+SUC, and not at all the case for AP. Thus, this study showed that despite carbohydrates being encapsulated in a hydrogel, a higher CHO EXO  was observed following MD+FRU drink ingestion compared to AP and MD+SUC consumption upon exposure to the acidic environment of the stomach. This finding may be related to the higher fructose content of the MD+FRU drink compared with the MD+SUC and AP drinks. Furthermore, a carbohydrate solution without added acidulants, which are commonly included in commercial sport drinks, may have less deleterious effects on oral health.",2020,"Exogenous carbohydrate oxidation (CHO EXO ) during the 2nd hour of exercise was significantly ( P  < 0.05) different between all three drinks: MD+FRU (1.17 ± 0.17 g·min -1 ), MD+SUC (1.01 ± 0.13 g·min -1 ), and AP (0.84 ± 0.11 g·min -1 ).","['dental exposure to low pH', '2 ± 7.7 years,    V   ˙', '12 endurance athletes (age 31']","['Hydrogel Drink With High Fructose Content', 'amylopectin starch (AP), maltodextrin+sucrose (MD+SUC), or maltodextrin+fructose hydrogel (MD+FRU) drinks']","['Biofilm acidogenicity', 'CHO EXO  and blood glucose concentrations', 'Exogenous Carbohydrate Oxidation and Lower Dental Biofilm pH', 'pH fall for MD+FRU', 'substrate oxidation', 'dental biofilm pH', 'Exogenous carbohydrate oxidation (CHO EXO ']","[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0728725', 'cui_str': 'Low pH'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002728', 'cui_str': 'Amylopectin'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]","[{'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",12.0,0.0885326,"Exogenous carbohydrate oxidation (CHO EXO ) during the 2nd hour of exercise was significantly ( P  < 0.05) different between all three drinks: MD+FRU (1.17 ± 0.17 g·min -1 ), MD+SUC (1.01 ± 0.13 g·min -1 ), and AP (0.84 ± 0.11 g·min -1 ).","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pettersson', 'Affiliation': 'Department of Food and Nutrition, and Sport Science, Center for Health and Performance, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ahnoff', 'Affiliation': 'Maurten AB, Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Edin', 'Affiliation': 'Department of Food and Nutrition, and Sport Science, Center for Health and Performance, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lingström', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Simark Mattsson', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Andersson-Hall', 'Affiliation': 'Department of Physiology, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00088']
1355,32580977,Home monitoring with technology-supported management in chronic heart failure: a randomised trial.,"OBJECTIVES


We aimed to investigate whether digital home monitoring with centralised specialist support for remote management of heart failure (HF) is more effective in improving medical therapy and patients' quality of life than digital home monitoring alone.
METHODS


In a two-armed partially blinded parallel randomised controlled trial, seven sites in the UK recruited a total of 202 high-risk patients with HF (71.3 years SD 11.1; left ventricular ejection fraction 32.9% SD 15.4). Participants in both study arms were given a tablet computer, Bluetooth-enabled blood pressure monitor and weighing scales for health monitoring. Participants randomised to intervention received additional regular feedback to support self-management and their primary care doctors received instructions on blood investigations and pharmacological treatment. The primary outcome was the use of guideline-recommended medical therapy for chronic HF and major comorbidities, measured as a composite opportunity score (total number of recommended treatment given divided by the total number of opportunities the treatment should have been given, with a score 1 indicating 100% adherence to recommendations). Co-primary outcome was change in physical score of Minnesota Living with Heart Failure questionnaire.
RESULTS


101 patients were randomised to 'enhanced self-management' and 101 to 'supported medical management'. At the end of follow-up, the opportunity score was 0.54 (95% CI 0.46 to 0.62) in the control arm and 0.61 (95% CI 0.52 to 0.70) in the intervention arm (p=0.25). Physical well-being of participants also did not differ significantly between the groups (17.4 (12.4) mean (SD) for control arm vs 16.5 (12.1) in treatment arm; p for change=0.84).
CONCLUSIONS


Central provision of tailored specialist management in a multi-morbid HF population was feasible. However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life.
TRIAL REGISTRATION NUMBER


ISRCTN86212709.",2020,"However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life.
","['seven sites in the UK recruited a total of 202 high-risk patients with HF (71.3 years', 'chronic heart failure', '101 patients']","[""enhanced self-management' and 101 to 'supported medical management"", 'digital home monitoring with centralised specialist support', 'additional regular feedback to support self-management and their primary care doctors received instructions on blood investigations and pharmacological treatment', 'Home monitoring with technology-supported management', 'tablet computer, Bluetooth-enabled blood pressure monitor and weighing scales for health monitoring']","['use of guideline-recommended medical therapy for chronic HF and major comorbidities', 'physical score of Minnesota Living with Heart Failure questionnaire']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0702196', 'cui_str': 'Blood investigation'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C4045980', 'cui_str': 'Tablet Computers'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",202.0,0.142842,"However, there was no strong evidence for improvement in use of evidence-based treatment nor health-related quality of life.
","[{'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Rahimi', 'Affiliation': 'Deep Medicine, Oxford Martin School, University of Oxford, Oxford, United Kingdom kazem.rahimi@georgeinstitute.ox.ac.uk.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Nazarzadeh', 'Affiliation': 'Deep Medicine, Oxford Martin School, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ana-Catarina', 'Initials': 'AC', 'LastName': 'Pinho-Gomes', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, Medical Science Division, University of Oxford, Oxford, United Kingdom.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Salimi-Khorshidi', 'Affiliation': 'Deep Medicine, Oxford Martin School, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, The University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Fitzpatrick', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'Institute of Biomedical Engineering, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Denis', 'Affiliation': 'Oxford Academic Health Science Network, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cleland', 'Affiliation': 'National Heart and Lung Institute, Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Heart (British Cardiac Society),['10.1136/heartjnl-2020-316773']
1356,32581204,[Therapeutic Response to 20 mg of Esomeprazole Twice Daily in Patients with Gastroesophageal Reflux Disease-related Non-cardiac Chest Pain: An Open-Label Randomized Pilot Study].,"Background/Aims


Non-cardiac chest pain (NCCP) is defined as recurrent angina pectoris-like pain without evidence of coronary heart disease, and is usually related to esophageal diseases, such as gastroesophageal reflux disease (GERD). Proton pump inhibitors (PPIs) are important for diagnosis and treatment. Many studies have been conducted on the use of PPIs in patients with GERD-related NCCP. In contrast to standard-dose esomeprazole, the efficacy of half-dose esomeprazole twice daily (BD) has not been established. This study compared the efficacies of the two esomeprazole regimens in GERD-related NCCP.
Methods


In this prospective, open-label study, 37 participants with GERD-related NCCP were randomized to receive either 20 mg of esomeprazole BD (n=21) (esomeprazole BD group) or 40 mg once daily (n=16) (esomeprazole once daily [OD] group) for 4 weeks. In both groups, the chest pain score, which was calculated based on the frequency and severity, was evaluated before and 2 and 4 weeks after administering the medication.
Results


The chest pain score significantly improved in both groups (p<0.001). The proportion of patients with chest pain score improvement >50% was 7.7% higher in the esomeprazole BD group than in the esomeprazole OD group (95.2% vs. 87.5%), but the difference was not significant.
Conclusions


Esomeprazole BD was as effective as esomeprazole OD in improving GERD-related NCCP. Although statistically insignificant, the percentage of patients with >50% reduction in the chest pain score was higher in the esomeprazole BD group than in the esomeprazole OD group. Large-scale studies will be needed to assess these findings further.",2020,The chest pain score significantly improved in both groups (p<0.001).,"['patients with GERD-related NCCP', '37 participants with GERD-related NCCP', 'Patients with Gastroesophageal Reflux Disease-related Non-cardiac Chest Pain']","['esomeprazole OD', 'esomeprazole BD', 'esomeprazole', '/Aims\n\n\nNon-cardiac chest pain (NCCP', 'esomeprazole BD (n=21) (esomeprazole BD group) or 40 mg once daily (n=16) (esomeprazole', 'Esomeprazole BD', 'Esomeprazole', 'Proton pump inhibitors (PPIs']","['chest pain score', 'proportion of patients with chest pain score improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0476281', 'cui_str': 'Non-cardiac chest pain'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0476281', 'cui_str': 'Non-cardiac chest pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",37.0,0.0232623,The chest pain score significantly improved in both groups (p<0.001).,"[{'ForeName': 'Jae Kyun', 'Initials': 'JK', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Hyun Ik', 'Initials': 'HI', 'LastName': 'Shim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Cheol Min', 'Initials': 'CM', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Hyuk', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Young Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}]",The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi,['10.4166/kjg.2020.75.6.333']
1357,32581275,Publisher Correction: Different exercise training modalities produce similar endothelial function improvements in individuals with prehypertension or hypertension: a randomized clinical trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['individuals with prehypertension or hypertension'],"['Publisher Correction', 'exercise training modalities']",['endothelial function improvements'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0456419,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Marinei L', 'Initials': 'ML', 'LastName': 'Pedralli', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Marschner', 'Affiliation': 'Thyroid Section, Endocrine Division, Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Kollet', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Salvador G', 'Initials': 'SG', 'LastName': 'Neto', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Eibel', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Aging Research Laboratory, Department of Kinesiology & Health Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alexandre M', 'Initials': 'AM', 'LastName': 'Lehnen', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil. amlehnen@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-67586-2']
1358,32592973,Impact of 80 kVp with iterative reconstruction algorithm and low-dose contrast medium on the image quality of craniocervical CT angiography.,"PURPOSE


To assess the image quality of 80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM).
METHODS


A total of 119 patients were randomly divided into three groups. For group A, 120-kVp protocol was followed with 60 ml CM and filtered back projection; for group B, 80-kVp protocol with 60 ml CM and ASIR-V; and for group C, 80-kVp protocol with 45 ml CM and ASIR-V. Both subjective and objective image quality and radiation doses were evaluated.
RESULTS


Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions were significantly higher in groups B and C compared with group A. Group C yielded significantly better subjective image quality than that observed in groups A and B (both p < .05). As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
CONCLUSIONS


The CCCTA protocol with 80 kVp, ASIR-V, and 45 ml of CM injected at 3 ml/s significantly reduced the radiation dose, iodine load, and iodine delivery rate while providing better subjective and objective image quality, including higher arterial enhancement and a higher SNR and CNR compared with the 120-kVp protocol.",2020,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
",['A total of 119 patients'],"['80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM', '80\xa0kVp with iterative reconstruction algorithm and low-dose contrast medium']","['image quality of craniocervical CT angiography', 'subjective image quality', 'radiation dose, iodine load, and iodine delivery rate', 'Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",119.0,0.0319457,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
","[{'ForeName': 'Po-An', 'Initials': 'PA', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chiung-Chen', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Jui-Hsun', 'Initials': 'JH', 'LastName': 'Fu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shuo-Hsiu', 'Initials': 'SH', 'LastName': 'Hsu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Lai', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: pinghonglai@gmail.com.'}]",Clinical imaging,['10.1016/j.clinimag.2020.05.024']
1359,32472804,Goal-directed versus Standard Fluid Therapy to Decrease Ileus after Open Radical Cystectomy: A Prospective Randomized Controlled Trial.,"BACKGROUND


Postoperative ileus is a common complication of intraabdominal surgeries, including radical cystectomy with reported rates as high as 32%. Perioperative fluid administration has been associated with improvement in postoperative ileus rates, but it is difficult to generalize because earlier studies lacked standardized definitions of postoperative ileus and other relevant outcomes. The hypothesis was that targeted individualized perioperative fluid management would improve postoperative ileus in patients receiving radical cystectomy.
METHODS


This is a parallel-arm, double-blinded, single-center randomized trial of goal-directed fluid therapy versus standard fluid therapy for patients undergoing open radical cystectomy. The primary outcome was postoperative ileus, and the secondary outcome was complications within 30 days post-surgery. Participants were at least 21 yr old, had a maximum body mass index of 45 kg/m and no active atrial fibrillation. The intervention in the goal-directed therapy arm combined preoperative and postoperative stroke volume optimization and intraoperative stroke volume variation minimization to guide fluid administration, using advanced hemodynamic monitoring.
RESULTS


Between August 2014 and April 2018, 283 radical cystectomy patients (142 goal-directed fluid therapy and 141 standard fluid therapy) were included in the analysis. Postoperative ileus occurred in 25% (36 of 142) of patients in the goal-directed fluid therapy arm and 21% (30 of 141) of patients in the standard arm (difference in proportions, 4.1%; 95% CI, -5.8 to 13.9; P = 0.418). There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
CONCLUSIONS


Goal-directed fluid therapy may not be an effective strategy for lowering the risk of postoperative ileus in patients undergoing open radical cystectomy.",2020,"There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
","['patients undergoing open radical cystectomy', '283 radical cystectomy patients (142 goal-directed fluid therapy and 141 standard fluid therapy', 'patients having radical cystectomy', 'patients receiving radical cystectomy', 'Participants were at least 21 yr old, had a maximum body mass index of 45 kg/m and no active atrial fibrillation', 'Between August 2014 and April 2018']","['fluid therapy versus standard fluid therapy', 'intraoperative fluid therapy over standard fluid therapy', 'Standard Fluid Therapy', 'Open Radical Cystectomy', 'goal-directed therapy arm combined preoperative and postoperative stroke volume optimization and intraoperative stroke volume variation minimization to guide fluid administration, using advanced hemodynamic monitoring']","['incidence of high-grade complications', 'postoperative ileus', 'Postoperative ileus']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic monitoring'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}]",,0.569234,"There was no difference in incidence of high-grade complications between the two arms (20 of 142 [14%] vs. 23 of 141 [16%]; difference in proportions, -2.2%; 95% CI, -10.6 to 6.1; P = 0.602), with the exception of acute kidney injury, which was more frequent in the goal-directed fluid therapy arm (56% [80 of 142] vs. 40% [56 of 141] in the standard arm; difference in proportions, 16.6%; 95% CI, 5.1 to 28.1; P = 0.005; P = 0.170 after adjustment for multiple testing).
","[{'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Arslan-Carlon', 'Affiliation': 'From the Department of Anesthesiology and Critical Care Medicine, Anesthesiology Service (V.A.-C., A.C.P., M.F.) the Department of Epidemiology and Biostatistics (K.S.T.) the Department of Surgery, Urology Service (G.D., H.W.H., B.H.B., E.K.C., T.F.D., S.M.D.), Memorial Sloan Kettering Cancer Center, New York, New York the Departments of Urology (G.D., H.W.H., B.H.B., E.K.C., S.M.D.) Anesthesiology (A.C.P., M.F.), Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Kay See', 'Initials': 'KS', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Dalbagni', 'Affiliation': ''}, {'ForeName': 'Alessia C', 'Initials': 'AC', 'LastName': 'Pedoto', 'Affiliation': ''}, {'ForeName': 'Harry W', 'Initials': 'HW', 'LastName': 'Herr', 'Affiliation': ''}, {'ForeName': 'Bernard H', 'Initials': 'BH', 'LastName': 'Bochner', 'Affiliation': ''}, {'ForeName': 'Eugene K', 'Initials': 'EK', 'LastName': 'Cha', 'Affiliation': ''}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Donahue', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'S Machele', 'Initials': 'SM', 'LastName': 'Donat', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003367']
1360,32471373,"Percutaneous mastoid electrical stimulator improves Poststroke depression and cognitive function in patients with Ischaemic stroke: a prospective, randomized, double-blind, and sham-controlled study.","BACKGROUND


Poststroke depression can lead to functional dependence, cognitive impairment and reduced quality of life. The aim of this study was to evaluate the effects of a percutaneous mastoid electrical stimulator (PMES) plus antidepressants on poststroke depression and cognitive function.
METHODS


This study was a prospective, randomized, double-blind, and sham-controlled study. A total of 258 clinically depressed ischaemic stroke patients within 14 days of index stroke were randomly assigned to the PMES plus antidepressant (PMES group, N = 125) and sham plus antidepressant (sham group, N = 133) groups. All patients underwent the Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test at 2 weeks (baseline), and 6 months(M6) after ischaemic stroke. Primary outcomes were the percentage of patients showing a treatment response (≥50% reduction in HRSD score) and depression remission (HRSD score ≤ 9) at 6 months. The secondary outcome was the percentage of patients with a MoCA score < 26.
RESULTS


The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively). The mean value of the HRSD score change [M (month)6-baseline] was significantly higher in the PMES group than in the sham group at 6 months (- 11.93 ± 5.32 vs - 10.48 ± 6.10, P = 0.036, respectively). The percentage of patients with MoCA scores < 26 was lower in the PEMS group than in the sham group (12.0% vs 24.06%, P = 0.012,respectively), and the mean value of the MoCA score change (M6-baseline) was higher in the PMES group than in the sham group (3.50 ± 2.55 vs 2.72 ± 2.52, P = 0.005, respectively).
CONCLUSION


These findings demonstrate that PMES adjunctive to antidepressant therapy is effective in reducing depression, achieving remission in the short term, and improving cognition.
TRIAL REGISTRATION


This trial was retrospectively registered (registration number: ChiCTR1800016463) on 03 June 2018.",2020,"The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively).","['258 clinically depressed ischaemic stroke patients within 14\u2009days of index stroke', 'patients with Ischaemic stroke']","['PMES', 'PMES plus antidepressant (PMES group, N\u2009=\u2009125) and sham plus antidepressant', 'percutaneous mastoid electrical stimulator (PMES) plus antidepressants', 'Percutaneous mastoid electrical stimulator']","['mean value of the MoCA score change (M6-baseline', 'treatment response and depression remission', 'mean value of the HRSD score change [M (month)6-baseline', 'Montreal Cognitive Assessment (MoCA) and Hamilton Rating Scale for Depression (HRSD) test', 'Poststroke depression and cognitive function', 'percentage of patients with a MoCA score\u2009<\u200926', 'poststroke depression and cognitive function', 'percentage of patients showing a treatment response', 'percentage of patients with MoCA scores', 'HRSD score) and depression remission (HRSD score']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0446908', 'cui_str': 'Mastoid structure'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",258.0,0.250207,"The percentages of patients showing a treatment response and depression remission were significantly higher in the PMES group than in the sham group (57.60% vs 41.35%, P = 0.009; 44.00% vs 29.32%, P = 0.014 respectively).","[{'ForeName': 'Taoli', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Lanying', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China. 531324679@qq.com.""}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Chengdu, Chengdu, 610021, PR China.""}, {'ForeName': 'Wei Wei', 'Initials': 'WW', 'LastName': 'Dong', 'Affiliation': 'Department of Neurology, First Affiliated Hospital, Chongqing Medical University, Chongqing, 400030, PR China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'College of Electrical Engineering, Institute of Electrical Technology, Chongqing University, Chongqing, 400030, PR China.'}]",BMC neurology,['10.1186/s12883-020-01795-0']
1361,32474507,Para-aortic lymph node tracing and dissection in advanced gastric cancer: Effectiveness of carbon nanoparticles injection through the no. 12b lymph node.,"Background and Objectives


The relative effectiveness of tracers in guiding para-aortic lymph node dissection (PAND) in advanced gastric cancer is undefined. In this single-center, prospective study, we aimed to discuss the effectiveness of such tracers.
Materials and Methods


Between January 2015 and January 2016, 90 consecutive patients with stage T4a gastric cancer were evenly assigned to receive 0.2 mL of carbon nanoparticles (a), methylene blue (b), or no tracer (c) injection through no. 12b lymph nodes before PAND.
Results


There was no difference in the baseline characteristics between the three groups. Group A vs. B or C had a higher number of dissected lymph nodes (34.1 ± 9.8, 25.5 ± 5.5, and 22.6 ± 3.7; P < 0.001; B vs. C: P =0.321) and no. 16a2/b1 para-aortic lymph nodes (PANs; 11.8 ± 4.8, 7.0 ± 1.2, and 5.5 ± 1.2; P < 0.001; B vs. C: P =0.178) and similar rates of lymph node metastasis (20.9 ± 17.5%, 19.1 ± 15.1%, and 23.6 ± 19.7%; P = 0.511), positive dissected PAN (23.3% [7/30], 16.7% [5/30], and 16.7% [5/30]), surgery duration (252.9 + 35.4, 244.4 ± 29.0, and 250.3 + 29.9 min; P = 0.421), and blood loss (266.7 ± 115.5, 270.0 ± 82.6, and 260.0 ± 116.3 mL, P = 0.933). There was no common bile duct damage by tracer injection, and one case of duodenal stump fistula, one abdominal infection, and two anastomotic leakages in Groups A-C, respectively, were treated successfully.
Conclusions


In advanced gastric cancer treatment, carbon nanoparticle injection into no. 12b nodes appears to better trace no. 16a2/b1 PAN.",2020,"There was no common bile duct damage by tracer injection, and one case of duodenal stump fistula, one abdominal infection, and two anastomotic leakages in Groups A-C, respectively, were treated successfully.
","['advanced gastric cancer', 'Between January 2015 and January 2016, 90 consecutive patients with stage T4a gastric cancer']","['carbon nanoparticles (a), methylene blue (b), or no tracer (c) injection through no. 12b lymph nodes before PAND', 'carbon nanoparticles injection']","['number of dissected lymph nodes', 'positive dissected PAN', 'surgery duration', 'blood loss', 'rates of lymph node metastasis']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0475395', 'cui_str': 'Tumor stage T4a'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0229789', 'cui_str': 'Structure of aortic lymph node'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}]",90.0,0.0505995,"There was no common bile duct damage by tracer injection, and one case of duodenal stump fistula, one abdominal infection, and two anastomotic leakages in Groups A-C, respectively, were treated successfully.
","[{'ForeName': 'Guangchuan', 'Initials': 'G', 'LastName': 'Mu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Zhibai', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Xingan', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Biomedical Engineering Center, Beijing University of Technology, Beijing, China.'}]",Journal of cancer research and therapeutics,['10.4103/jcrt.JCRT_506_19']
1362,32483058,"Effects of hypnosis, cognitive therapy, hypnotic cognitive therapy, and pain education in adults with chronic pain: a randomized clinical trial.","Chronic pain is a significant health problem worldwide with limited pharmacological treatment options. This study evaluated the relative efficacy of 4 treatment sessions each of 4 nonpharmacological treatments: (1) hypnotic cognitive therapy (using hypnosis to alter the meaning of pain); (2) standard cognitive therapy; (3) hypnosis focused on pain reduction, and (4) pain education. One hundred seventy-three individuals with chronic pain were randomly assigned to receive 4 sessions of 1 of the 4 treatments. Primary (pain intensity) and secondary outcome measures were administered by assessors unaware of treatment allocation at pretreatment, posttreatment, and 3-, 6-, and 12-month follow-up. Treatment effects were evaluated using analysis of variance, a generalized estimating equation approach, or a Fisher exact test, depending on the outcome domain examined. All 4 treatments were associated with medium to large effect size improvements in pain intensity that maintained up to 12 months posttreatment. Pretreatment to posttreatment improvements were observed across the 4 treatment conditions on the secondary outcomes of pain interference and depressive symptoms, with some return towards pretreatment levels at 12-month follow-up. No significant between-group differences emerged in omnibus analyses, and few statistically significant between-group differences emerged in the planned pairwise analyses, although the 2 significant effects that did emerge favored hypnotic cognitive therapy. Future research is needed to determine whether the significant differences that emerged are reliable.",2020,All four treatments were associated with medium to large effect size improvements in pain intensity that maintained up to 12 months post-treatment.,"['adults with chronic pain', 'One hundred seventy-three individuals with chronic pain']","['hypnosis, cognitive therapy, hypnotic cognitive therapy, and pain education', 'hypnotic cognitive therapy', 'standard cognitive therapy; (3) hypnosis focused on pain reduction, and (4) pain education', 'Pre']","['hypnotic cognitive therapy', 'pain intensity', 'pain interference and depressive symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",173.0,0.0592179,All four treatments were associated with medium to large effect size improvements in pain intensity that maintained up to 12 months post-treatment.,"[{'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'Maria Elena', 'Initials': 'ME', 'LastName': 'Mendoza', 'Affiliation': ''}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Patterson', 'Affiliation': ''}, {'ForeName': 'Ivan R', 'Initials': 'IR', 'LastName': 'Molton', 'Affiliation': ''}, {'ForeName': 'Tiara M', 'Initials': 'TM', 'LastName': 'Dillworth', 'Affiliation': ''}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Gertz', 'Affiliation': ''}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Hakimian', 'Affiliation': ''}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Battalio', 'Affiliation': ''}, {'ForeName': 'Marcia A', 'Initials': 'MA', 'LastName': 'Ciol', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000001943']
1363,32479807,Short-Term Changes in Prediction Error after Cataract Surgery in Eyes Receiving 1 of 3 Types of Single-Piece Acrylic Intraocular Lenses.,"PURPOSE


To compare short-term changes in refractive prediction error (PE) after phacoemulsification among eyes receiving different types of single-piece acrylic intraocular lenses (IOLs).
DESIGN


Randomized clinical trial.
METHODS


A total of 195 eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL were randomly assigned to receive 1 of 3 IOLs: 1) an Alcon model SN60WF, 2) a Hoya model XY-1, or 3) an AMO model ZCB00V. Manifest spherical equivalent (MRSE) value, PE, and changes in PE were examined at 1 day and at 1 and 2 months postoperatively and were compared among groups.
RESULTS


The mean MRSE and PE significantly changed toward myopia between 1 day and 2 months postoperatively in all groups (P < .0001). The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P ≤ .0006). The PE change between 1 day and 2 months postoperatively was significantly smaller in the SN60WF group than in the other groups (P = .0062). IOL type and changes in anterior chamber depth and corneal curvature independently correlated with PE changes.
CONCLUSIONS


The MRSE and PE showed a significant myopic change for 2 months postoperatively in eyes implanted with 1 of 3 types of single-piece acrylic IOLs and were significantly smaller in the SN60WF than in the XY-1 and ZCB00V groups. Changes in PE during the 2 postoperative months were smaller in the SN60WF IOLs than in the other IOLs, suggesting that postoperative refractive stability differs among single-piece acrylic IOLs.",2020,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","['One-hundred ninety-five eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL', 'eyes receiving different types of single-piece acrylic intraocular lenses (IOLs']",['SN60WF'],"['PE change', 'IOL type, and changes in anterior chamber depth and corneal curvature', 'mean MRSE and PE', 'MRSE and PE', 'AMO ZCB00V. Manifest spherical equivalent value (MRSE), PE, and changes in PE', 'refractive prediction error (PE']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",195.0,0.0496226,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan. Electronic address: hayashi-ken@hayashi.or.jp.'}, {'ForeName': 'Motoaki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Hayashi', 'Affiliation': 'Department of Ophthalmology, National Hospital Organization Saitama Hospital, Saitama, Japan; Department of Ophthalmology, Keio University Faculty of Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.05.031']
1364,32586939,Clinical Significance of Circulating Tumor Cells in Hormone Receptor-positive Metastatic Breast Cancer Patients who Received Letrozole with or Without Bevacizumab.,"PURPOSE


We evaluated the prognostic and predictive value of circulating tumor cells (CTCs) hormone receptor-positive (HR + ) metastatic breast cancer (MBC) patients randomized to letrozole alone or letrozole plus bevacizumab in the first-line setting (CALGB 40503).
EXPERIMENTAL DESIGN


Blood samples were collected at pretreatment and three additional time points during therapy. The presence of ≥5 CTCs per 7.5 mL of blood was considered CTC positive. Association of CTCs with progression-free survival (PFS) and overall survival (OS) was assessed using Cox regression models.
RESULTS


Of 343 patients treated, 294 had CTC data and were included in this analysis. Median follow-up was 39 months. In multivariable analysis, CTC-positive patients at baseline (31%) had significantly reduced PFS [HR, 1.49; 95% confidence interval (CI), 1.12-1.97] and OS (HR, 2.08; 95% CI, 1.49-2.93) compared with CTC negative. Failure to clear CTCs during treatment was associated with significantly increased risk of progression (HR, 2.2; 95% CI, 1.58-3.07) and death (HR, 3.4; 95% CI, 2.36-4.88). CTC-positive patients who received only letrozole had the worse PFS (HR, 2.3; 95% CI, 1.54-3.47) and OS (HR, 2.6; 95% CI, 1.59-4.40). Median PFS in CTC-positive patients was significantly longer (18.0 vs. 7.0 months) in letrozole plus bevacizumab versus letrozole arm ( P  = 0.0009). Restricted mean survival time analysis further revealed that addition of bevacizumab was associated with PFS benefit in both CTC-positive and CTC-negative patients, but OS benefit was only observed in CTC-positive patients.
CONCLUSIONS


CTCs were highly prognostic for the addition of bevacizumab to first-line letrozole in patients with HR+ MBC in CALGB 40503. Further research to determine the potential predictive value of CTCs in this setting is warranted.",2020,only Let had the worse PFS (HR=2.3; 95% CI: 1.54-3.47) and OS (HR=2.6; 95% CI: 1.59-4.40).,"['hormone receptor-positive metastatic breast cancer patients who received', 'CTC-positive patients who received', '343 patients treated, 294 had CTC data and were included in this analysis', 'patients with HR+ MBC']","['letrozole with or without bevacizumab', 'letrozole (Let) alone or letrozole plus bevacizumab (Let+Bev']","['OS benefit', 'Median PFS', 'PFS', 'death', 'Association of CTCs with progression-free survival (PFS) and overall survival (OS', 'risk of progression', 'worse PFS']","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",,0.146634,only Let had the worse PFS (HR=2.3; 95% CI: 1.54-3.47) and OS (HR=2.6; 95% CI: 1.59-4.40).,"[{'ForeName': 'Mark Jesus M', 'Initials': 'MJM', 'LastName': 'Magbanua', 'Affiliation': 'University of California at San Francisco, San Francisco, California. mark.magbanua@ucsf.edu.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Savenkov', 'Affiliation': 'Weill Medical College of Cornell University, New York, New York.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Asmus', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Alliance Statistics and Data Center, Weill Medical College of Cornell University, New York, New York.'}, {'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Scott', 'Affiliation': 'University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'University of California at San Francisco, San Francisco, California.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Dickler', 'Affiliation': 'Lilly Oncology, Indianapolis, Indiana.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Partridge', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California at San Francisco, San Francisco, California.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1329']
1365,32592578,Efficacy of Combined Antigravity Treadmill and Conventional Rehabilitation After Hip Fracture in Patients With Sarcopenia.,"BACKGROUND


To compare long-term effects of antigravity treadmill (AGT) combined with conventional rehabilitation (CR) and CR after hip fracture in patients with sarcopenia.
METHODS


Forty-five patients were randomly allocated to AGT combined with CR (experimental group) or CR (control group) for 10 consecutive working days. Participants were evaluated prior to treatment, 3 weeks, 3 months, and 6 months after treatment. Outcome measurement included Koval walking ability scores functional ambulatory category (FAC), Berg Balance Scale (BBS), Korean version of Mini-Mental State Examination, Euro Quality of Life Questionnaire Five-Dimensional Classification, Korean version of modified Barthel index, and grip strength.
RESULTS


At 3 weeks and 3 months, the comparison of change scores in KOVAL between two groups revealed difference of 0.84 (95% CI: -1.19, -0.49; p for trend = .000) and 1.21 (95% CI: -2.05, -0.36; p for trend = .006), respectively. At 3 weeks, comparison of change score in FAC between two groups revealed a difference of 0.73 (95% CI: 0.28, 1.19; p for trend = .003). The comparison of change scores between two groups also showed a difference in the 6 months in KOVAL and in the 3 and 6 months in FAC. The comparison of changes in scores in BBS between two groups revealed difference of 11.63 (95% CI: 5.85, 17.40; p for trend = .001), 9.00 (95% CI: 2.28, 15.71; p for trend = .006), and 11.05 (95% CI: 3.62, 18.48; p for trend = .006), respectively, at each follow-up.
CONCLUSIONS


Both groups were improved after intervention. As additional benefits were evident among those who carried out AGT, it may be appropriate for patients with sarcopenia after hip fracture surgery.",2020,"At 3 weeks, comparison of change score in FAC between two groups revealed a difference of 0.73 (95% CI: 0.28, 1.19; p for trend = .003).","['45 patients', 'patients with sarcopenia', 'patients with sarcopenia after hip fracture surgery']","['antigravity treadmill (AGT) combined with conventional rehabilitation (CR) and CR', 'combined antigravity treadmill and conventional rehabilitation', 'AGT combined with CR (experimental group) or CR (control group']","['Koval walking ability scores functional ambulatory category (FAC), Berg Balance Scale (BBS), Korean version of Mini-Mental Status Examination, Euro Quality of Life Questionnaire Five-Dimensional Classification, Korean version of modified Barthel index, and grip strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}]",45.0,0.125777,"At 3 weeks, comparison of change score in FAC between two groups revealed a difference of 0.73 (95% CI: 0.28, 1.19; p for trend = .003).","[{'ForeName': 'Min-Kyun', 'Initials': 'MK', 'LastName': 'Oh', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, Korea.'}, {'ForeName': 'Jun-Il', 'Initials': 'JI', 'LastName': 'Yoo', 'Affiliation': 'Department of Orthopaedic Surgery, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, Korea.'}, {'ForeName': 'Hayoung', 'Initials': 'H', 'LastName': 'Byun', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, Korea.'}, {'ForeName': 'Se-Woong', 'Initials': 'SW', 'LastName': 'Chun', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University Changwon Hospital, Korea.'}, {'ForeName': 'Seung-Kyu', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University Changwon Hospital, Korea.'}, {'ForeName': 'Yun Jeong', 'Initials': 'YJ', 'LastName': 'Jang', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, Korea.'}, {'ForeName': 'Chang Han', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, Korea.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa158']
1366,32597889,[Use of Detravenol in treatment of chronic venous insufficiency of lower limbs].,"AIM


The purpose of this study was to prove that Detravenol is not inferior by clinical efficacy to Detralex® in the course administration in patients presenting with chronic venous insufficiency of the lower extremities caused by lower limb varicose veins.
PATIENTS AND METHODS


Ours was a prospective randomized open-liable comparative trial aimed at determining efficacy and safety of the two drugs in parallel groups with active control. The trial enrolled a total of 106 patients with chronic venous insufficiency of the lower extremities secondary to lower limb varicose veins. The patients took the drug during 60 days twice daily. The primary outcome measure of efficacy was reduction of the malleolar circumference upon completion of treatment as compared with the baseline values, with the secondary outcome measures being the dynamics of parameters according to the Venous Clinical Severity Score (VCSS), CIVIQ-2 quality of life questionnaire, and the findings of ultrasonographic duplex scanning.
RESULTS


The obtained findings demonstrated efficacy of therapy with the use of Detravenol in treatment of patients with chronic venous insufficiency of the lower limbs. The 60-day therapy with the study drug resulted in decreased oedema of the lower extremities: the malleolar circumference reduced averagely by 4%, the composite index of the venous clinical severity score diminished averagely by 50%, and the subjective measure of quality of life increased. Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed.
CONCLUSION


By the primary outcome measure of efficacy (reduction of the malleolar circumference) therapy using the investigational drug proved to be not inferior to therapy with the comparator drug. By the secondary outcome measures the compared therapies appeared equally effective. The study drug and the comparator were found to have a similar safety profile.",2020,"Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed.
","['patients presenting with chronic venous insufficiency of the lower extremities caused by lower limb varicose veins', 'patients with chronic venous insufficiency of the lower limbs', '106 patients with chronic venous insufficiency of the lower extremities secondary to lower limb varicose veins', 'chronic venous insufficiency of lower limbs']","['Detralex®', 'Detravenol']","['efficacy (reduction of the malleolar circumference) therapy', 'Venous Clinical Severity Score (VCSS), CIVIQ-2 quality of life questionnaire, and the findings of ultrasonographic duplex scanning', 'efficacy and safety', 'malleolar circumference upon completion of treatment', 'oedema of the lower extremities: the malleolar circumference', 'efficacy', 'composite index of the venous clinical severity score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}]","[{'cui': 'C0379896', 'cui_str': 'Detralex'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",106.0,0.038315,"Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed.
","[{'ForeName': 'É A', 'Initials': 'ÉA', 'LastName': 'Ponomarev', 'Affiliation': 'Department of Hospital Surgery, Volgograd State Medical University, Volgograd, Russia.'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Strepetov', 'Affiliation': 'Department of Hospital Surgery, Volgograd State Medical University, Volgograd, Russia.'}, {'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Sotnikov', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': ""Vasil'ev"", 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Arnautov', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'I S', 'Initials': 'IS', 'LastName': 'Kasatkina', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Bukhtenkov', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}]",Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery,['10.33529/ANGI02020201']
1367,32600949,A nomogram for prediction of distant metastasis in children with wilms tumor: A study based on SEER database.,"INTRODUCTION


Accurate diagnosis of distant metastasis especially uncommon site of metastasis (UCM) in patients with Wilms tumor (WTs) is a demanding prerequisite for administration of appropriate therapy and achieving better survival outcome.
OBJECTIVE


To develop and validate a nomogram to predict probability of distant metastasis, and identify population demanded for rigorous imaging evaluations in children with WTs.
MATERIAL AND METHODS


Data of patients diagnosed with unilateral WTs and aged under 18 years old, were extracted from the Surveillance, Epidemiology, and End Results (SEER) database. The included patients were randomly allocated to the training and the validation cohort. Logistic regression analyses were performed to identify the independent risk factors and develop a predicting model of distant metastasis in WTs. The model-based nomogram was created and internally validated. Cut-off value of nomogram points was derived by using the receiver operating characteristics (ROC) curve analysis. Performance of the nomogram was evaluated in terms of discrimination, calibration and clinical usefulness.
RESULTS


A total 717 WTs patients were included in the study. Age at diagnosis (OR 1.173, 95%CI: 1.079-1.279), LND (OR 8.260, 95%CI: 2.837-24.814) and tumor size (OR 2.141, 95%CI: 1.378-3.329) were identified as the independent risk factors of distant metastasis in WTs. These three factors were incorporated to develop a model and a nomogram. The nomogram presented with good discriminative ability in the training cohort (C-statistics, 0.703) and validation cohort (C-statistics, 0.764), respectively. The calibration curves demonstrated adequate agreement between predicted probability and observed probability of distant metastasis. The nomogram also revealed its clinical usefulness by application of decision curve analysis (DCA). Cut-off value of nomogram points was 58 and its corresponding probability of distant metastasis was 0.22. The value was applied in risk stratification dividing the general cohort into high-risk and low-risk group.
DISCUSSION


Our study for the first time developed and validated a model and a visualized nomogram for individualized prediction of distant metastasis in WTs. C-statistics, calibration curves and DCA demonstrated good performance and clinical usefulness of the nomogram. Patients stratified as high-risk group were demanded for rigorous imaging evaluations to accurately identify UCM.
CONCLUSION


The nomogram, developed by incorporation of three independent risk factors, which are age at diagnosis, LND and tumor size, is used to facilitate individualized prediction of distant metastasis in WTs. Rigorous imaging evaluations are recommended for patients in high-risk group to identify UCM.",2020,"The nomogram presented with good discriminative ability in the training cohort (C-statistics, 0.703) and validation cohort (C-statistics, 0.764), respectively.","['children with wilms tumor', 'children with WTs', 'A total 717 WTs patients were included in the study', 'Data of patients diagnosed with unilateral WTs and aged under 18 years old, were extracted from the Surveillance, Epidemiology, and End Results (SEER) database', 'patients in high-risk group to identify UCM', 'patients with Wilms tumor (WTs']",[],['tumor size '],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027708', 'cui_str': 'Nephroblastoma'}, {'cui': 'C1839736', 'cui_str': 'Wilson-Turner X-linked mental retardation syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0522498', 'cui_str': 'Rare'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475440', 'cui_str': 'Tumor size'}]",717.0,0.03782,"The nomogram presented with good discriminative ability in the training cohort (C-statistics, 0.703) and validation cohort (C-statistics, 0.764), respectively.","[{'ForeName': 'Yangyue', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China.""}, {'ForeName': 'Hongcheng', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China. Electronic address: drsunningbch@sina.com.""}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.05.158']
1368,32599257,"A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.","Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.",2020,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","['Patients with heart failure who are clinically eligible for an ICD are eligible for the study', 'Patients offered implantable Cardioverter-DEfibrillators', 'patients who have chronic progressive illness', '900 participants']","['implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation', 'shared DECision Support Intervention']",['decision quality (defined by knowledge and values-treatment concordance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0983498,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","[{'ForeName': 'Bryan C', 'Initials': 'BC', 'LastName': 'Wallace', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Knoepke', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO.'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Lewis', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Fairclough', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Helmkamp', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Monica D', 'Initials': 'MD', 'LastName': 'Fitzgerald', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Tzou', 'Affiliation': 'Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kramer', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Varosy', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Cardiology Section, VA Eastern Colorado Health Care System, Aurora, CO.'}, {'ForeName': 'Sanjaya K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Saint Luke's Mid-America Heart Institute, Kansas City, MO.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mandrola', 'Affiliation': 'Baptist Health Louisville, Louisville, KY.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Brancato', 'Affiliation': 'Providence Heart Institute, Portland, OR.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Peterson', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.'}]",American heart journal,['10.1016/j.ahj.2020.04.010']
1369,32599445,A comparison of the three year course between chronic depression and depression with multiple vs. few prior episodes.,"This study tested the hypothesis that chronic depression (CD) is more similar to depression with multiple prior episodes (ME) than to depression with few prior episodes (FE). Data from participants (n = 1013) with mild to moderate depressive symptoms (Patient Health Questionnaire [PHQ-9] score 5 - 14) who took part in a randomized control trial of an internet intervention for depression (EVIDENT trial) were re-analyzed. The MINI-interview was conducted to diagnose CD (n = 376). If CD was not diagnosed, the self-reported number of depressive episodes was used to categorize participants as having episodic depression with up to five (FE, n = 422) or more than five (ME, n = 215) prior episodes. Over a three-year period, participants were assessed repeatedly regarding the course of depression (PHQ-9, QIDS), quality of life (SF-12) and therapeutic progress (FEP-2). At baseline, most scores were different between CD and FE but comparable between CD and ME. Time to remission did not differ between CD and ME but was longer in CD compared to FE. Results suggest that ME closely resembles CD and that CD differs from FE.",2020,Time to remission did not differ between CD and ME but was longer in CD compared to FE.,['Data from participants (n\xa0=\xa01013) with mild to moderate depressive symptoms (Patient Health Questionnaire [PHQ-9] score 5 - 14) who took part in a randomized control trial of an'],['internet intervention'],"['Time to remission', 'course of depression (PHQ-9, QIDS), quality of life (SF-12) and therapeutic progress (FEP-2']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}]",1013.0,0.0348744,Time to remission did not differ between CD and ME but was longer in CD compared to FE.,"[{'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Humer', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Kocsis-Bogar', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical-Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Späth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, 23538 Lübeck, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Research Department, Gaia AG, Hamburg, Germany; Department of Psychology, City, University of London, United Kingdom.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical-Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Lutz', 'Affiliation': 'Department of Psychology, University of Trier, Trier, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Probst', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, 23538 Lübeck, Germany. Electronic address: philipp.klein@uksh.de.'}]",Psychiatry research,['10.1016/j.psychres.2020.113235']
1370,32603560,Impact of Concurrent Posttraumatic Stress Disorder on Outcomes of Antipsychotic Augmentation for Major Depressive Disorder With a Prior Failed Treatment: VAST-D Randomized Clinical Trial.,"OBJECTIVE


To determine whether concurrent posttraumatic stress disorder (PTSD) should affect whether to augment or switch medications when major depressive disorder (MDD) has not responded to a prior antidepressant trial.
METHODS


Patients at 35 Veterans Health Administration medical centers from December 2012 to May 2015 with nonpsychotic MDD (N = 1,522) and a suboptimal response to adequate antidepressant treatment were randomly assigned to 3 ""next step"" treatments: switching to bupropion, augmenting the current antidepressant with bupropion, and augmenting with the antipsychotic aripiprazole. Blinded ratings with the 16-item Quick Inventory of Depressive Symptomatology-Clinician Rated (QIDS-C₁₆) determined remission and response by 12 weeks and relapse after remission. Survival analyses compared treatment effects in patients with concurrent PTSD diagnosed with the Mini-International Neuropsychiatric Interview (n = 717, 47.1%) and those without PTSD (n = 805, 52.9%).
RESULTS


Patients diagnosed with PTSD showed more severe depressive symptoms at baseline and were less likely to achieve either remission or response by 12 weeks. Augmentation with aripiprazole was associated with greater likelihood of achieving response (68.4%) than switching to bupropion (57.7%) in patients with PTSD (relative risk [RR] = 1.26; 95% CI, 1.01-1.59) as well as in patients without PTSD (RR = 1.29; 95% CI, 1.05-1.97) (78.9% response with aripiprazole augmentation vs 66.9% with switching to bupropion). Treatment comparisons with the group receiving augmentation with bupropion were not significant. There was no significant interaction between treatment group and PTSD on remission (P = .70), response (P = .98), or relapse (P = .15).
CONCLUSIONS


Although PTSD was associated with poorer overall outcomes, the presence of concurrent PTSD among Veterans in this trial did not affect the comparative effectiveness of medications on response, remission, or relapse after initial remission.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01421342.",2020,"RESULTS


Patients diagnosed with PTSD showed more severe depressive symptoms at baseline and were less likely to achieve either remission or response by 12 weeks.","['Patients at 35 Veterans Health Administration medical centers from December 2012 to May 2015 with nonpsychotic MDD (N = 1,522) and a suboptimal response to adequate antidepressant treatment', 'Major Depressive Disorder', 'patients with concurrent PTSD diagnosed with the Mini-International Neuropsychiatric Interview (n = 717, 47.1%) and those without PTSD (n = 805, 52.9', 'concurrent posttraumatic stress disorder (PTSD']","['aripiprazole', 'bupropion', 'bupropion, augmenting the current antidepressant with bupropion, and augmenting with the antipsychotic aripiprazole', 'Antipsychotic Augmentation']","['Depressive Symptomatology-Clinician Rated (QIDS-C₁₆) determined remission and response', 'response, remission, or relapse', 'severe depressive symptoms', 'likelihood of achieving response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0645933,"RESULTS


Patients diagnosed with PTSD showed more severe depressive symptoms at baseline and were less likely to achieve either remission or response by 12 weeks.","[{'ForeName': 'Somaia', 'Initials': 'S', 'LastName': 'Mohamed', 'Affiliation': 'VA Connecticut Healthcare System, 950 Campbell Ave, Mailstop (182), West Haven, CT 06516. somaia.mohamed@va.gov.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Johnson', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, Connecticut, USA.'}, {'ForeName': 'Varadan', 'Initials': 'V', 'LastName': 'Sevilimedu', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, Connecticut, USA.'}, {'ForeName': 'Sanjai D', 'Initials': 'SD', 'LastName': 'Rao', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Hicks', 'Affiliation': 'Baylor Scott and White Health, Temple, Texas, USA.'}, {'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Lauro', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Jurjus', 'Affiliation': 'Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pilkinton', 'Affiliation': 'Tuscaloosa VA Medical Center, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Davis', 'Affiliation': 'Tuscaloosa VA Medical Center, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Wilcox', 'Affiliation': 'Tucson VA Medical Center, Tucson, Arizona, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Iranmanesh', 'Affiliation': 'Salem VA Medical Center, Salem, Virginia, USA.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Sapra', 'Affiliation': 'Salem VA Medical Center, Salem, Virginia, USA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Aslam', 'Affiliation': 'Cincinnati VA Medical Center, Cincinatti, Ohio, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Michalets', 'Affiliation': 'Charles George VA Medical Center, Asheville, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thase', 'Affiliation': 'Philadelphia VA Medical Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Zisook', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'The names of all participants in the VAST-D Study are listed in Supplementary Appendix 1.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13038']
1371,32603561,Preventive Cognitive Therapy With Antidepressant Discontinuation During Pregnancy: Results From a Randomized Controlled Trial.,,2020,,[],['Preventive Cognitive Therapy With Antidepressant Discontinuation'],[],[],"[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",[],,0.056871,,"[{'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Molenaar', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Psychiatry, 1425 Madison Ave, New York, NY 10029. nina.molenaar@mssm.edu.'}, {'ForeName': 'Marlies E', 'Initials': 'ME', 'LastName': 'Brouwer', 'Affiliation': ''}, {'ForeName': 'Huibert', 'Initials': 'H', 'LastName': 'Burger', 'Affiliation': ''}, {'ForeName': 'Astrid M', 'Initials': 'AM', 'LastName': 'Kamperman', 'Affiliation': ''}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Bergink', 'Affiliation': ''}, {'ForeName': 'Witte J G', 'Initials': 'WJG', 'LastName': 'Hoogendijk', 'Affiliation': ''}, {'ForeName': 'Alishia D', 'Initials': 'AD', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Claudi L H', 'Initials': 'CLH', 'LastName': 'Bockting', 'Affiliation': ''}, {'ForeName': 'Mijke P', 'Initials': 'MP', 'LastName': 'Lambregtse-van den Berg', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.19l13099']
1372,32684314,Comparison of intraoperative outcomes with single and double puncture techniques of arthrocentesis of the temporomandibular joint.,"Evidence of differences in operator-related outcomes between single and double puncture arthrocentesis is limited. The purpose of this prospective study was to compare intraoperative outcomes with single puncture types 1 and 2, and double puncture, arthrocentesis. A total of 59 patients with 60 temporomandibular joints (TMJ) were treated sequentially by single puncture type 1 (n=20), single puncture type 2 (n=20), and double puncture arthrocentesis (n=20). Total operating time, incidence of dislocation of the needle, preauricular swelling, and ease of operation were compared. Single puncture type 2 arthrocentesis took significantly less time than type 1 (p<0.0001) or double puncture arthrocentesis (p<0.0001), but there was no difference in operating time between single puncture type 1 and the double puncture technique (p=0.25). There were significantly fewer dislocations of the needle with single puncture type 1 (p=0.041) and single puncture type 2 (p=0.033) than with double arthrocentesis. Single puncture type 2 arthrocentesis was easier than the single puncture type 1 (p=0.001) or double puncture technique (p<0.0001). Extravasation of fluid caused swelling in seven patients after double puncture, and in three patients each after single puncture types 1 and 2, arthrocentesis. Our results indicate that the single puncture type 2 technique is easiest and requires the least operating time. There was no difference between single puncture type 1 and double puncture arthrocentesis in terms of operating time or ease of the procedure. There were fewer operative dislocations of the needle with the single than with the double puncture technique.",2020,Single puncture type 2 arthrocentesis was easier than the single puncture type 1 (p=0.001) or double puncture technique (p<0.0001).,"['59 patients with 60 temporomandibular joints (TMJ', 'arthrocentesis of the temporomandibular joint']","['single puncture type 2 (n=20), and double puncture arthrocentesis']","['operating time', 'Extravasation of fluid caused swelling', 'Total operating time, incidence of dislocation of the needle, preauricular swelling, and ease of operation', 'operative dislocations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",59.0,0.258854,Single puncture type 2 arthrocentesis was easier than the single puncture type 1 (p=0.001) or double puncture technique (p<0.0001).,"[{'ForeName': 'Shakil Ahmed', 'Initials': 'SA', 'LastName': 'Nagori', 'Affiliation': 'Oral & Maxillofacial Surgeon, 21 Corps Dental Unit, c/o 56 APO. Electronic address: drshakilnagori@gmail.com.'}, {'ForeName': 'Anson', 'Initials': 'A', 'LastName': 'Jose', 'Affiliation': 'Faculty, Department of Oral & Maxillofacial Surgery, Army Dental Centre (Research & Referral), New Delhi.'}, {'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Roychoudhury', 'Affiliation': 'Professor & Head of Department, Department of Oral & Maxillofacial Surgery, All India Institute of Medical Sciences, New Delhi.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.04.011']
1373,32619413,Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: retrospective long-term follow-up of the LIR!C trial.,"BACKGROUND


The LIR!C trial showed that laparoscopic ileocaecal resection is a cost-effective treatment that has similar quality-of-life outcomes to treatment with infliximab, an anti-tumour necrosis factor (TNF) drug. We aimed to compare long-term outcomes of both interventions and identify baseline factors associated with the duration of treatment effect in each group.
METHODS


In this retrospective follow-up study, we collected data from patients who participated in the LIR!C trial, a multicentre randomised controlled trial that compared quality of life after surgical resection versus infliximab in adult patients with non-stricturing and immunomodulator-refractory ileocaecal Crohn's disease. From Jan 1 to May 1, 2018, we collected follow-up data from the time from enrolment in the LIR!C trial until the last visit at either the gastrointestinal surgeon or gastroenterologist. In this study, outcomes of interest were need for surgery or repeat surgery or anti-TNF therapy, duration of treatment effect, and identification of factors associated with the duration of treatment effect. Duration of treatment effect was defined as the time without need for additional Crohn's disease-related treatment (corticosteroids, immunomodulators, biologics, or surgery).
FINDINGS


We collected long-term follow-up data for 134 (94%) of 143 patients included in the LIR!C trial, of whom 69 were in the resection group and 65 were in the infliximab group. Median follow-up was 63·5 months (IQR 39·0-94·5). In the resection group, 18 (26%) of 69 patients started anti-TNF therapy and none required a second resection. 29 (42%) patients in the resection group did not require additional Crohn's disease-related medication, although 14 (48%) of these patients were given prophylactic immunomodulator therapy. In the infliximab group, 31 (48%) of 65 patients had a Crohn's disease-related resection, and the remaining 34 patients maintained, switched, or escalated their anti-TNF therapy. Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52). In both groups, therapy with an immunomodulator, in addition to the allocated treatment, was associated with duration of treatment effect (hazard ratio for resection group 0·34 [95% CI 0·16-0·69] and for infliximab group 0·49 [0·26-0·93]).
INTERPRETATION


These findings further support laparoscopic ileocaecal resection as a treatment option in patients with Crohn's disease with limited (affected segment ≤40 cm) and predominantly inflammatory terminal ileitis for whom conventional treatment is not successful.
FUNDING


None.",2020,"Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52).","[""patients with Crohn's disease with limited (affected segment ≤40 cm"", '134 (94%) of 143 patients included in the LIR!C trial, of whom 69 were in the resection group and 65 were in the infliximab group', 'patients who participated in the LIR!C trial', ""Crohn's disease"", ""adult patients with non-stricturing and immunomodulator-refractory ileocaecal Crohn's disease""]","['infliximab', 'laparoscopic ileocaecal resection', 'surgical resection versus infliximab', 'Laparoscopic ileocaecal resection versus infliximab']","[""time without need for additional Crohn's disease-related treatment (corticosteroids, immunomodulators, biologics, or surgery"", 'Duration of treatment effect']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001551', 'cui_str': 'Immunologic adjuvant'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0700426', 'cui_str': 'Ileocecal'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0400056', 'cui_str': 'Right hemicolectomy and end to end anastomosis of ileum to colon'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0001551', 'cui_str': 'Immunologic adjuvant'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.135364,"Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52).","[{'ForeName': 'Toer W', 'Initials': 'TW', 'LastName': 'Stevens', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Haasnoot', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Christianne J', 'Initials': 'CJ', 'LastName': 'Buskens', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'E Joline', 'Initials': 'EJ', 'LastName': 'de Groof', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Eshuis', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Tjibbe J', 'Initials': 'TJ', 'LastName': 'Gardenbroek', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Bregje', 'Initials': 'B', 'LastName': 'Mol', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Pieter C F', 'Initials': 'PCF', 'LastName': 'Stokkers', 'Affiliation': 'Department of Gastroenterology and Hepatology, OLVG West, Amsterdam, Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Bemelman', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. Electronic address: w.a.bemelman@amsterdamumc.nl.'}, {'ForeName': 'Cyriel Y', 'Initials': 'CY', 'LastName': 'Ponsioen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30117-5']
1374,32619524,Design of a randomized placebo controlled trial of high dose intravenous thiamine for the prevention of delirium in allogeneic hematopoietic stem cell transplantation.,"BACKGROUND


Delirium is a highly prevalent and preventable neuropsychiatric condition with major health consequences. Thiamine deficiency is a well-established cause of delirium in those with chronic, severe alcoholism, but there remains an underappreciation of its significance in non-alcoholic populations, including patients with cancer. Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
OBJECTIVES


The primary objective of this clinical trial is to determine if high dose IV thiamine can prevent delirium in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer. Secondary objectives are to determine if thiamine status is predictive of delirium onset and if high dose IV thiamine can attenuate the deleterious impact of delirium on health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes.
METHODS


In this phase II study, we are recruiting 60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose IV thiamine (n = 30) versus placebo (n = 30), and systematically evaluating all participants for delirium and related comorbidities. We use the Delirium Rating Scale to measure the severity and duration of delirium during hospitalization for HSCT. We obtain thiamine levels weekly during the transplantation hospitalization. We assess HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function prior to and at one, three, and six months after transplantation.",2020,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","['60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose', 'patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'patients with cancer']","['Placebo', 'Thiamine', 'thiamine', 'intravenous (IV) thiamine', 'IV thiamine', 'placebo']","['HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function', 'Delirium Rating Scale', 'health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.367689,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","[{'ForeName': 'Zev M', 'Initials': 'ZM', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: zev_nakamura@med.unc.edu.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Rosenstein', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Quillen', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Chien', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Eliza M', 'Initials': 'EM', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106076']
1375,32475262,Comparison between embryos transferred with self-spent and fresh medium on reproductive outcomes: a prospective randomized trial.,"As the final and critical step in  in   vitro  fertilization (IVF), embryo transfer has always received much attention and deserves continuous optimization. In the present study, to explore the role of autocrine factors in embryo self-spent culture media, we prospectively compared embryo transfer with self-spent culture medium and fresh medium on clinical pregnancy outcomes. A total of 318 fresh IVF/intracytoplasmic sperm injection (ICSI) cycles were randomly allocated into two subgroups based on their transfer media (using a self-spent culture medium or new pre-equilibrated culture media), and the clinical outcomes were compared between groups. The implantation rates, clinical pregnancy rates and live birth rates for transfer using self-spent medium instead of new pre-equilibrated culture medium were slightly improved without statistical significance. Interestingly, however, biochemical pregnancy rate was found to be significantly decreased after transfer using self-spent medium for Day 3 embryos compared with new pre-equilibrated culture media. In short, embryo transfer with self-spent culture medium has shown some advantages, and large sample size studies are still needed to confirm these observations.
ABBREVIATIONS


ART: assisted reproductive technologies; ICSI: intracytoplasmic sperm injection; IVF: in vitro fertilization; ET: embryo transfer.",2020,"Interestingly, however, biochemical pregnancy rate was found to be significantly decreased after transfer using self-spent medium for Day 3 embryos compared with new pre-equilibrated culture media.",['A total of 318 fresh IVF/intracytoplasmic sperm injection (ICSI) cycles'],"['embryos transferred with self-spent and fresh medium', 'embryo transfer with self-spent culture medium and fresh medium']","['implantation rates, clinical pregnancy rates and live birth rates for transfer using self-spent medium instead of new pre-equilibrated culture medium', 'reproductive outcomes', 'biochemical pregnancy rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0010454', 'cui_str': 'Culture medium'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0010454', 'cui_str': 'Culture medium'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}]",318.0,0.0386931,"Interestingly, however, biochemical pregnancy rate was found to be significantly decreased after transfer using self-spent medium for Day 3 embryos compared with new pre-equilibrated culture media.","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Reproductive Medicine Department, Jinan Central Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences , Jinan, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Reproductive Medicine Center, Gansu Provincial Maternity and Child-Care Hospital , Lanzhou, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'Reproductive Medicine Department, Jinan Central Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences , Jinan, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Reproductive Medicine Department, Jinan Central Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences , Jinan, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'Reproductive Medicine Center, Gansu Provincial Maternity and Child-Care Hospital , Lanzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'School of Life Science, Shandong University , Jinan, China.'}, {'ForeName': 'Yunshan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Cheeloo College of Medicine, Shandong University , Jinan, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Reproductive Medicine Department, Jinan Central Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences , Jinan, China.'}]",Systems biology in reproductive medicine,['10.1080/19396368.2020.1764132']
1376,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
1377,32485734,Cardiovascular Benefit of Empagliflozin Across the Spectrum of Cardiovascular Risk Factor Control in the EMPA-REG OUTCOME Trial.,"CONTEXT


Control of multiple cardiovascular (CV) risk factors reduces CV events in individuals with type 2 diabetes.
OBJECTIVE


To investigate this association in a contemporary clinical trial population, including how CV risk factor control affects the CV benefits of empagliflozin, a sodium-glucose cotransporter-2 inhibitor.
DESIGN


Post hoc analysis.
SETTING


Randomized CV outcome trial (EMPA-REG OUTCOME).
PARTICIPANTS


Type 2 diabetes patients with established CV disease.
INTERVENTION


Empagliflozin or placebo.
MAIN OUTCOME MEASURES


Risk of CV outcomes-including the treatment effect of empagliflozin-by achieving 7 goals for CV risk factor control at baseline: (1) glycated hemoglobin <7.5%, (2) low-density lipoprotein cholesterol <100 mg/dL or statin use, (3) systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg, (4) pharmacological renin-angiotensin-aldosterone system blockade, (5) normoalbuminuria, (6) aspirin use, (7) nonsmoking.
RESULTS


In the placebo group, the hazard ratio (HR) for CV death was 4.00 (95% CI, 2.26-7.11) and 2.48 (95% CI, 1.52-4.06) for patients achieving only 0-3 or 4-5 risk factor goals at baseline, respectively, compared with those achieving 6-7 goals. Participants achieving 0-3 or 4-5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82-4.57] and 1.90 [1.31-2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53-3.19] and 1.42 [1.06-1.89]). Empagliflozin significantly reduced these outcomes across all risk factor control categories (P > 0.05 for treatment-by-subgroup interactions).
CONCLUSIONS


Cardiovascular risk in EMPA-REG OUTCOME was inversely associated with baseline CV risk factor control. Empagliflozin's cardioprotective effect was consistent regardless of multiple baseline risk factor control.",2020,"Participants achieving 0-3 or 4-5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82-4.57] and 1.90 [1.31-2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53-3.19] and 1.42 [1.06-1.89]).",['individuals with type 2 diabetes (T2D'],"['empagliflozin', 'Empagliflozin or placebo', 'Empagliflozin', 'EMPA', 'placebo']","['hazard ratio (HR) for CV death', 'risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke', 'risk factor control categories', 'baseline CV risk factor control', '3-point major adverse CV events', 'Risk of CV outcomes - including treatment effect of empagliflozin - by achievement of seven goals for CV risk factor control at baseline: glycated hemoglobin <7.5%, low-density lipoprotein cholesterol <100 mg/dL or statin use, systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg, pharmacological renin-angiotensin-aldosterone system blockade, normoalbuminuria, aspirin use, non-smoking.\nRESULTS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.196854,"Participants achieving 0-3 or 4-5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82-4.57] and 1.90 [1.31-2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53-3.19] and 1.42 [1.06-1.89]).","[{'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fitchett', 'Affiliation': ""Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Division of Nephrology, Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mattheus', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa321']
1378,32590064,Improving the safety of shoulder arthroscopy in the beach chair position: a prospective randomized trial investigating the effect of compression stockings on cerebral desaturation events in obese patients.,"BACKGROUND


Devastating transient and permanent postoperative neurocognitive complications in previously healthy, low-risk patients have been observed after elective shoulder arthroscopy in the beach chair position (BCP). Continuous monitoring of cerebral oxygen saturation has been recommended to identify cerebral desaturation events (CDEs) and improve patient safety. However, the relatively high cost and limited availability of monitoring may not be cost-effective. More cost-effective and available measures, including the use of thigh-high compression stockings (CS), have been investigated. However, efficacy data of CS usage is limited, especially for obese patients, who have been shown to be at increased risk for CDEs. The purpose of this was study was to determine if the intraoperative addition of thigh-high compression stockings decreases the incidence, frequency, and magnitude of CDEs in obese patients undergoing shoulder arthroscopy in the BCP.
METHODS


Thirty-three patients in the treatment group wore both thigh-high compression stockings (CS) and sequential compression devices (SCDs), and the remaining 33 patients in the control group wore SCDs alone. Cerebral oximetry was monitored during surgery using near-infrared spectroscopy.
RESULTS


The incidence of CDEs was equal between groups, with 9 patients (27%) in each experiencing desaturation events. The median number of CDEs per patient was 3 for the control group and 1 for patients wearing CS (P = .29). There was no difference between groups in terms of median time from induction of anesthesia to onset of CDE (P = .79), median time from upright positioning to onset of CDE (P = .60), mean CDE duration per patient (P = .22), and median cumulative CDE duration (P = .19). The median maximal desaturation from baseline was also not different between groups: 27.6% in the control group and 24.3% in the treatment group (P = .35).
CONCLUSION


The combination of thigh-high CS and SCDs did not decrease the incidence, frequency, or magnitude of CDEs in patients undergoing shoulder arthroscopy in the BCP. Twenty-seven percent of patients undergoing shoulder arthroscopy in the BCP demonstrated CDEs with or without the use of CS. Therefore, further research is required to identify cost-effective, minimally invasive, and universally available methods of decreasing the incidence of CDEs during this common surgical procedure.",2020,"The incidence of CDEs was equal between groups, with 9 patients (27%) in each experiencing desaturation events.","['previously healthy, low risk patients', 'obese patients undergoing shoulder arthroscopy in the BCP', 'High Risk Patients', 'obese patients', 'patients undergoing shoulder arthroscopy in the BCP']","['thigh-high compression stockings (CS) and sequential compression devices (SCDs', 'thigh-high compression stockings (CS', 'thigh-high compression stockings', 'Compression Stockings', 'control group wore SCDs alone', 'Shoulder Arthroscopy']","['incidence of CDEs', 'median time from induction of anesthesia to onset of CDE', 'incidence, frequency, or magnitude of CDEs', 'median number of CDEs', 'Cerebral Desaturation Events', 'median time from upright positioning to onset of CDE', 'incidence, frequency, and magnitude of CDEs', 'Cerebral oximetry', 'cerebral desaturation events', 'median cumulative CDE duration', 'mean CDE duration', 'median maximal desaturation']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0559702', 'cui_str': 'Arthroscopy of shoulder'}, {'cui': 'C2316745', 'cui_str': 'Beach chair position'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C2711456', 'cui_str': 'Intermittent pneumatic compression stockings'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559702', 'cui_str': 'Arthroscopy of shoulder'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0108844', 'cui_str': 'CDE protocol'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",33.0,0.112122,"The incidence of CDEs was equal between groups, with 9 patients (27%) in each experiencing desaturation events.","[{'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Golz', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, Maywood, IL, USA. Electronic address: Andrew.Golz@lumc.edu.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Davis', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, Maywood, IL, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Perry', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, Maywood, IL, USA.'}, {'ForeName': 'Pietro M', 'Initials': 'PM', 'LastName': 'Tonino', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, Maywood, IL, USA.'}, {'ForeName': 'Nickolas G', 'Initials': 'NG', 'LastName': 'Garbis', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, Maywood, IL, USA.'}, {'ForeName': 'Dane H', 'Initials': 'DH', 'LastName': 'Salazar', 'Affiliation': 'Loyola University Medical Center, Stritch School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, Maywood, IL, USA.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.05.037']
1379,32590084,Blood transfusion and ischaemic outcomes according to anemia and bleeding in patients with non-ST-segment elevation acute coronary syndromes: Insights from the TAO randomized clinical trial.,"BACKGROUND


The benefits and risks of blood transfusion in patients with acute myocardial infarction who are anemic or who experience bleeding are debated. We sought to study the association between blood transfusion and ischemic outcomes according to haemoglobin nadir and bleeding status in patients with NST-elevation myocardial infarction (NSTEMI).
METHODS


The TAO trial randomized patients with NSTEMI and coronary angiogram scheduled within 72h to heparin plus eptifibatide versus otamixaban. After exclusion of patients who underwent coronary artery bypass surgery, patients were categorized according to transfusion status considering transfusion as a time-varying covariate. The primary ischemic outcome was the composite of all-cause death or MI within 180 days of randomization. Subgroup analyses were performed according to pre-transfusion hemoglobin nadir and bleeding status.
RESULTS


12,547 patients were enrolled. Among these, blood transfusion was used in 489 (3.9%) patients. Patients who received transfusion had a higher rate of death or MI (29.9% vs. 8.1%, p<0.01). This excess risk persisted after adjustment on GRACE score and nadir of hemoglobin (HR 3.36 95%CI 2.63-4.29 p<0.01). Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir > 9.0 g/dl (HR 4.01; p-interaction<0.0001).
CONCLUSION


In patients with NSTEMI, blood transfusion was associated with an overall increased risk of ischaemic events. However, this was mainly driven by patients without overt bleeding and those hemoglobin nadir > 9.0g/dl. This suggests possible harm of transfusion in those groups.",2020,Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir >,"['patients with NST-elevation myocardial infarction (NSTEMI', 'The TAO trial randomized patients with NSTEMI and coronary angiogram scheduled within 72h to', 'patients with acute myocardial infarction who are anemic or who experience bleeding are debated', 'patients with non-ST-segment elevation acute coronary syndromes', '12,547 patients were enrolled']","['blood transfusion', 'coronary artery bypass surgery', 'heparin plus eptifibatide versus otamixaban']","['anemia and bleeding', 'GRACE score and nadir of hemoglobin', 'risk of ischaemic events', 'composite of all-cause death or MI', 'Blood transfusion and ischaemic outcomes', 'rate of death or MI', 'blood transfusion', 'haemoglobin nadir and bleeding status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0040021', 'cui_str': 'Thromboangiitis obliterans'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0253563', 'cui_str': 'eptifibatide'}, {'cui': 'C1097497', 'cui_str': 'otamixaban'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",12547.0,0.115362,Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir >,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Deharo', 'Affiliation': 'Département de Cardiologie, CHU Timone, Marseille F-13385, France; Aix Marseille Univ, Inserm, Inra, C2VN, Marseille, France; Aix-Marseille Université, Faculté de Médecine, F-13385 Marseille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université de Paris, Institut National de la Santé et de la Recherche Médicale, Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Heart Center Freiburg University, Cardiology and Angiology I, Faculty of Medicine, Freiburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': 'Rutgers-New Jersey medical school, Newark, New Jersey, USA; Newark Beth Israel medical centre, Newark, New Jersey, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cuisset', 'Affiliation': 'Département de Cardiologie, CHU Timone, Marseille F-13385, France.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'McMaster University and the Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'C V', 'Initials': 'CV', 'LastName': 'Pollack', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Rao', 'Affiliation': 'Department of Cardiology, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands; The Netherlands Heart Institute, Utrecht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'University of Latvia, Pauls Stradins Clinical University Hospita, Riga, Latvia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Moccetti', 'Affiliation': 'Electrophysiology Unit, Department of Cardiology, Fondazione Cardiocentro Ticino, via Tesserete 48, 6900 Lugano, Switzerland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Elbez', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université de Paris, Institut National de la Santé et de la Recherche Médicale, Paris, France.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université de Paris, Institut National de la Santé et de la Recherche Médicale, Paris, France; National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, UK. Electronic address: gabriel.steg@aphp.fr.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.020']
1380,32593255,[Treatment of torpid trophic ulcers in patients of the older age group.],"Chronic ulcers or non-healing ulcers are more common in the elderly (20 out of 1 000 people), whose age is closer to 80 years. The application of the principles of regenerative medicine, actively developing, in the treatment of such diseases, is based on the use of both autologous blood derivatives and autologous mononuclear cells. Objective: to evaluate the effectiveness of the use of plasma enriched with platelets in the treatment of torpid ulcers of the lower extremities in patients of the older age group. A prospective, randomized clinical trial was conducted in 80 patients. According to preliminary calculations, it has been shown that the combination of traditional treatment with the introduction of plasma enriched with platelets leads to accelerated healing of ulcers.",2020,"Chronic ulcers or non-healing ulcers are more common in the elderly (20 out of 1 000 people), whose age is closer to 80 years.","['80 patients', 'patients of the older age group', 'torpid ulcers of the lower extremities in patients of the older age group']",[],['Chronic ulcers or non-healing ulcers'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",[],"[{'cui': 'C0333297', 'cui_str': 'Chronic ulcer'}, {'cui': 'C0205301', 'cui_str': 'Non-healed'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",1000.0,0.0160628,"Chronic ulcers or non-healing ulcers are more common in the elderly (20 out of 1 000 people), whose age is closer to 80 years.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Smagin', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Shumkov', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Soluianov', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'A U', 'Initials': 'AU', 'LastName': 'Demura', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Smagin', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Lykov', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Nimaev', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}]",Advances in gerontology = Uspekhi gerontologii,[]
1381,32594305,Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial.,"BACKGROUND AND OBJECTIVE


Omeprazole is a proton pump inhibitor that is used in acid suppression therapy in infants. Infants cannot swallow the oral tablets or capsules. Since, infants require a non-standard dose of omeprazole, the granules or tablets are often crushed or suspended in water or sodium bicarbonate, which may destroy the enteric coating. In this study we explore the efficacy and pharmacokinetics of rectally administered omeprazole in infants with gastroesophageal reflux disease (GERD) due to esophageal atresia (EA) or congenital diaphragmatic hernia (CDH) and compare these with orally administered omeprazole.
METHODS


Infants (6-12 weeks postnatal and bodyweight > 3 kg) with EA or CDH and GERD were randomized to receive a single dose of 1 mg/kg omeprazole rectally or orally. The primary outcome was the percentage of infants for whom omeprazole was effective according to predefined criteria for 24-h intraesophageal pH. Secondary outcomes were the percentages of time that gastric pH was < 3 or < 4, as well as the pharmacokinetic parameters.
RESULTS


Seventeen infants, 4 with EA and 13 with CDH, were included. The proportion of infants for whom omeprazole was effective was 56% (5 of 9 infants) after rectal administration and 50% (4 of 8 infants) after oral administration. The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration. Rectal and oral administration of omeprazole resulted in similar serum exposure.
CONCLUSIONS


A single rectal omeprazole dose (1 mg/kg) results in consistent increases in intraesophageal and gastric pH in infants with EA- or CDH-related GERD, similar to an oral dose. Considering the challenges with existing oral formulations, rectal omeprazole presents as an innovative, promising alternative for infants with pathological GERD.
CLINICAL TRIAL REGISTER


ClinicalTrials.gov Identifier: NCT00226044.",2020,The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration.,"['3\xa0kg) with EA or CDH and GERD', 'Infants', 'Seventeen infants, 4 with EA and 13 with CDH, were included', 'infants with gastroesophageal reflux disease (GERD) due to esophageal atresia (EA) or congenital diaphragmatic hernia (CDH', 'Infants (6-12\xa0weeks postnatal and bodyweight ', 'infants', 'With Gastroesophageal Reflux Disease', 'infants with pathological GERD']","['omeprazole', 'Rectal Omeprazole', 'Omeprazole', 'omeprazole rectally or orally', 'rectal omeprazole']","['efficacy and pharmacokinetics', 'percentages of time that gastric pH', 'intraesophageal and gastric pH', 'number of reflux episodes of pH', 'total reflux time']","[{'cui': 'C0014850', 'cui_str': 'Congenital atresia of esophagus'}, {'cui': 'C0235833', 'cui_str': 'Congenital diaphragmatic hernia'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1168023', 'cui_str': 'Gastric pH'}, {'cui': 'C2959898', 'cui_str': 'Intraesophageal route'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.126466,The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration.,"[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Bestebreurtje', 'Affiliation': 'Department of Clinical Pharmacology, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Barbara A E', 'Initials': 'BAE', 'LastName': 'de Koning', 'Affiliation': 'Division of Pediatric Gastroenterology, Department of Pediatrics, Erasmus MC Sophia, Rotterdam, The Netherlands.'}, {'ForeName': 'Nel', 'Initials': 'N', 'LastName': 'Roeleveld', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Catherijne A J', 'Initials': 'CAJ', 'LastName': 'Knibbe', 'Affiliation': 'Department of Clinical Pharmacology, St Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Tibboel', 'Affiliation': 'Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia, Rotterdam, The Netherlands.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'van Groen', 'Affiliation': 'Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia, Rotterdam, The Netherlands.'}, {'ForeName': 'Cees P', 'Initials': 'CP', 'LastName': 'van de Ven', 'Affiliation': 'Department of Pediatric Surgery, Prinses Maxima Hospital, Utrecht, The Netherlands.'}, {'ForeName': 'Frans B', 'Initials': 'FB', 'LastName': 'Plötz', 'Affiliation': 'Department of Pediatrics, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Saskia N', 'Initials': 'SN', 'LastName': 'de Wildt', 'Affiliation': 'Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia, Rotterdam, The Netherlands. Saskia.deWildt@radboudumc.nl.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00630-8']
1382,32604381,Omitting Routine Radiography of Traumatic Ankle Fractures After Initial 2-Week Follow-up Does Not Affect Outcomes: The WARRIOR Trial: A Multicenter Randomized Controlled Trial.,"BACKGROUND


The clinical consequences of routine follow-up radiographs for patients with ankle fracture are unclear, and their usefulness is disputed. The purpose of the present study was to determine if routine radiographs made at weeks 6 and 12 can be omitted without compromising clinical outcomes.
METHODS


This multicenter randomized controlled trial with a noninferiority design included 246 patients with an ankle fracture, 153 (62%) of whom received operative treatment. At 6 and 12 weeks of follow-up, patients in the routine-care group (n = 128) received routine radiographs whereas patients in the reduced-imaging group (n = 118) did not. The primary outcome was the Olerud-Molander Ankle Score (OMAS). Secondary outcomes were the American Academy of Orthopaedic Surgeons (AAOS) foot and ankle questionnaire, health-related quality of life (HRQoL) as measured with the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) and Short Form-36 (SF-36), complications, pain, health perception, self-perceived recovery, the number of radiographs, and the indications for radiographs to be made. The outcomes were assessed at baseline and at 6, 12, 26, and 52 weeks of follow-up. Data were analyzed with use of mixed models.
RESULTS


Reduced imaging was noninferior compared with routine care in terms of OMAS scores (difference [β], -0.9; 95% confidence interval [CI], -6.2 to 4.4). AAOS scores, HRQoL, pain, health perception, and self-perceived recovery did not differ between groups. Patients in the reduced-imaging group received a median of 4 radiographs, whereas those in the routine-care group received a median of 5 radiographs (p < 0.05). The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42). The types of complications were also similar.
CONCLUSIONS


Implementation of a reduced-imaging protocol following an ankle fracture has no measurable negative effects on functional outcome, pain, and complication rates during the first year of follow-up. The number of follow-up radiographs can be reduced by implementing this protocol.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42).","['patients with ankle fracture', '246 patients with an ankle fracture, 153 (62%) of whom received operative treatment', 'Traumatic Ankle Fractures']",['routine radiographs'],"['American Academy of Orthopaedic Surgeons (AAOS) foot and ankle questionnaire, health-related quality of life (HRQoL) as measured with the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) and Short Form-36 (SF-36), complications, pain, health perception, self-perceived recovery, the number of radiographs, and the indications for radiographs to be made', 'AAOS scores, HRQoL, pain, health perception, and self-perceived recovery', 'Olerud-Molander Ankle Score (OMAS', 'OMAS scores', 'functional outcome, pain, and complication rates', 'rates of complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]","[{'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",246.0,0.207996,"The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'van Gerven', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Krijnen', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Zuidema', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'El Moumni', 'Affiliation': 'Department of Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Rubinstein', 'Affiliation': 'Amsterdam Movement Science Research Institute, Department of Health Sciences, VU University, Amsterdam, the Netherlands.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Amsterdam Movement Science Research Institute, Department of Health Sciences, VU University, Amsterdam, the Netherlands.'}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Schipper', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Termaat', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01381']
1383,32611242,Plant Stanol Esters Reduce LDL (Low-Density Lipoprotein) Aggregation by Altering LDL Surface Lipids: The BLOOD FLOW Randomized Intervention Study.,"OBJECTIVE


Plant stanol ester supplementation (2-3 g plant stanols/d) reduces plasma LDL (low-density lipoprotein) cholesterol concentration by 9% to 12% and is, therefore, recommended as part of prevention and treatment of atherosclerotic cardiovascular disease. In addition to plasma LDL-cholesterol concentration, also qualitative properties of LDL particles can influence atherogenesis. However, the effect of plant stanol ester consumption on the proatherogenic properties of LDL has not been studied. Approach and Results: Study subjects (n=90) were randomized to consume either a plant stanol ester-enriched spread (3.0 g plant stanols/d) or the same spread without added plant stanol esters for 6 months. Blood samples were taken at baseline and after the intervention. The aggregation susceptibility of LDL particles was analyzed by inducing aggregation of isolated LDL and following aggregate formation. LDL lipidome was determined by mass spectrometry. Binding of serum lipoproteins to proteoglycans was measured using a microtiter well-based assay. LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm,  P =0.001. Plant stanol ester-induced decrease in LDL aggregation was more extensive in participants having body mass index<25 kg/m 2 . Decreased LDL aggregation susceptibility was associated with decreased proportion of LDL-sphingomyelins and increased proportion of LDL-triacylglycerols. LDL binding to proteoglycans was decreased in the plant stanol ester group, the decrease depending on decreased serum LDL-cholesterol concentration.
CONCLUSIONS


Consumption of plant stanol esters decreases the aggregation susceptibility of LDL particles by modifying LDL lipidome. The resulting improvement of LDL quality may be beneficial for cardiovascular health. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01315964.",2020,"LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm,  P =0.001.","['participants having body mass', 'Study subjects (n=90']","['plant stanol ester consumption', 'Plant stanol ester', 'Plant stanol ester supplementation', 'plant stanol ester-enriched spread (3.0 g plant stanols/d) or the same spread without added plant stanol esters', 'plant stanol esters', 'plant stanol ester', 'Plant Stanol Esters']","['plasma LDL (low-density lipoprotein) cholesterol concentration', 'LDL aggregation susceptibility', 'LDL aggregation', 'LDL binding to proteoglycans', 'Decreased LDL aggregation susceptibility', 'serum LDL-cholesterol concentration', 'LDL quality', 'proportion of LDL-triacylglycerols', 'aggregation susceptibility of LDL particles', 'median aggregate size']","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0872973', 'cui_str': 'plant stanol ester'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0033692', 'cui_str': 'Proteoglycan'}, {'cui': 'C0853085', 'cui_str': 'Low density lipoprotein decreased'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0065191', 'cui_str': 'Low density lipoprotein triglyceride'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",90.0,0.0510065,"LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm,  P =0.001.","[{'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Ruuth', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Äikäs', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Feven', 'Initials': 'F', 'LastName': 'Tigistu-Sahle', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Reijo', 'Initials': 'R', 'LastName': 'Käkelä', 'Affiliation': 'Molecular and Integrative Biosciences Research Programme, Faculty of Biological and Environmental Sciences (F.T.-S., R.K., K.Ö.), University of Helsinki, Finland.'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Lindholm', 'Affiliation': 'Finnish Institute of Occupational Health, Helsinki, Finland (H.L.).'}, {'ForeName': 'Piia', 'Initials': 'P', 'LastName': 'Simonen', 'Affiliation': 'Helsinki University Central Hospital, Heart and Lung Center, Cardiology (P.S., H.G.), University of Helsinki, Finland.'}, {'ForeName': 'Petri T', 'Initials': 'PT', 'LastName': 'Kovanen', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gylling', 'Affiliation': 'Helsinki University Central Hospital, Heart and Lung Center, Cardiology (P.S., H.G.), University of Helsinki, Finland.'}, {'ForeName': 'Katariina', 'Initials': 'K', 'LastName': 'Öörni', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.Ä., F.T.-S., P.T.K., K.Ö.).'}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.120.314329']
1384,32618212,Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial.,"Background:  Music can influence human behavior and may be used as a complementary therapy in health care.  Objectives:  To assess the effect of music interventions on symptoms, adverse events, and quality of life (QoL) of breast cancer patients undergoing chemotherapy (CT).  Design:  Nonblinded, randomized clinical trial. Women with breast cancer undergoing adjuvant CT were randomized into 2 groups-Group Music (GM) or Group Control (GC)-and followed during the first 3 cycles of treatment.  Measurements:  Sociodemographic data, WHOQOL-BREF, BDI-II, BAI, and Chemotherapy Toxicity Scale were assessed. Patients were evaluated after each session of the first 3 CT cycles. GM underwent a 30-minute musical intervention before CT. There was no intervention in the GC. Continuous data were analyzed by Student's  t  test, and χ 2  test was used to compare qualitative variables.  Results:  Higher QoL scores on functional scales were observed for the GM in comparison to the GC after the first and third sessions of CT. Depression ( P  < .001) and anxiety scores ( P  < .001) and vomiting ( P  < .01) incidence were lower for the GM in the third session of CT. All the participants in the GM reported positive changes in life in the Subjective Impression of the Subject questionnaire, as well as improvement in fatigue and reduced stress levels.  Conclusions:  Improvements in QoL, anxiety, depression, and incidence of vomiting were associated with the music intervention, suggesting a positive effect of the music intervention on adverse events of cancer CT.",2020,Higher QoL scores on functional scales were observed for the GM in comparison to the GC after the first and third sessions of CT.,"['breast cancer patients undergoing chemotherapy (CT', 'Breast Cancer Patients', 'Women with breast cancer undergoing adjuvant CT']","['Undergoing Chemotherapy', 'Music Intervention', 'music intervention', 'Group Music (GM) or Group Control (GC)-and', 'music interventions']","['QoL, anxiety, depression, and incidence of vomiting', 'Depression', 'symptoms, adverse events, and quality of life (QoL', 'Quality of Life', 'fatigue and reduced stress levels', 'Sociodemographic data, WHOQOL-BREF, BDI-II, BAI, and Chemotherapy Toxicity Scale', 'adverse events of cancer CT', 'vomiting', 'anxiety scores', 'Higher QoL scores on functional scales']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0919337,Higher QoL scores on functional scales were observed for the GM in comparison to the GC after the first and third sessions of CT.,"[{'ForeName': 'Talita Uchoa', 'Initials': 'TU', 'LastName': 'Lima', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Ed Carlos Rey', 'Initials': 'ECR', 'LastName': 'Moura', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Caio Márcio Barros de', 'Initials': 'CMB', 'LastName': 'Oliveira', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Rachel Jorge Dino Cossetti', 'Initials': 'RJDC', 'LastName': 'Leal', 'Affiliation': 'UDI and Aldenora Bello Hospitals, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Nogueira Neto', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Emanuel Cabral', 'Initials': 'EC', 'LastName': 'Pereira', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Raniere Victor Braga', 'Initials': 'RVB', 'LastName': 'Nascimento', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Eduardo José Silva Gomes de', 'Initials': 'EJSG', 'LastName': 'Oliveira', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Plínio da Cunha', 'Initials': 'PDC', 'LastName': 'Leal', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}]",Integrative cancer therapies,['10.1177/1534735420938430']
1385,32619619,"A commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis-an open labeled, randomized controlled trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.130852,,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Colorectal Surgery, Changhai Hospital, Second Military Medical University, 200433, Shanghai, China.'}, {'ForeName': 'Zubing', 'Initials': 'Z', 'LastName': 'Mei', 'Affiliation': 'Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, 201203, Shanghai, China; Anorectal Disease Institute of Shuguang Hospital, 201203, Shanghai, China. Electronic address: herrmayor@126.com.'}, {'ForeName': 'Guixin', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Jiaxing University, 314000, Jiaxing, Zhejiang Province, China. Electronic address: jxeysgx1191@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.06.036']
1386,32621898,The Aravind Pseudoexfoliation Study: 5-Year Postoperative Results. The Effect of Intraocular Lens Choice and Capsular Tension Rings.,"PURPOSE


We compared rates of intraocular lens (IOL) decentration, neodymium-doped yttrium aluminum garnet capsulotomy for posterior capsule opacification (PCO), and visual acuity (VA) in eyes with and without pseudoexfoliation (PEX) 5 years after undergoing cataract surgery.
DESIGN


Prospective comparative interventional study.
METHODS


This multicenter study population included 1 eye of both 930 cataract patients with and 470 cataract patients without uncomplicated PEX (no small pupils or phacodonesis) all undergoing phacoemulsification by experienced Aravind Eye Care System surgeons. Eyes were randomized to either 1- or 3-piece intraocular lenses (IOLs). PEX eyes were also randomized to either receive or not receive a capsule tension ring. The main outcome measures included IOL decentration and PCO. Secondary outcomes included postoperative best-corrected VA.
RESULTS


Follow-up was 86.2% in the PEX group and 86.7% in the control group at 5 years. The PEX group was older (P < .001) and had more men (P = .01). IOL decentration at 5 years was equally prevalent in PEX and control eyes (1.0% vs 1.1%, respectively, P = .8). Neodymium-doped yttrium aluminum garnet posterior capsulotomy rates for PCO were similar in the PEX group when compared with control subejcts (5.3% compared with 3.2%, respectively, P = .07). Best corrected VA was better at baseline and years 2 and 3 in the control group (P = .0001, P = .0005, and P = .02); however, there was no difference in BCVA at years 1, 4, and 5 between the PEX and control groups (P = .09, P = .29, and P = .5).
CONCLUSION


In a large-scale, long-term, prospective comparative study of cataract surgery in eyes with uncomplicated PEX, the risks of IOL decentration and PCO were low and comparable to that in control subjects. When approaching cataract surgery in eyes with relatively uncomplicated PEX, neither IOL choice (1- vs 3-piece acrylic IOL) nor the presence/absence of a capsule tension ring affects outcomes at 5 years.",2020,"Nd:YAG posterior capsulotomy rates for PCO were similar in the PEX group when compared to controls (5.3% compared to 3.2%, respectively, p=0.07).","['eyes with and without pseudoexfoliation (PEX) 5 years after undergoing cataract surgery', '930 cataract patients with, and 470 cataract patients without, uncomplicated PEX (no small pupils or phacodonesis) all undergoing phacoemulsification by experienced Aravind Eye Care System surgeons', 'PEX eyes']","['one-piece or three-piece intraocular lenses (IOL', 'PEX', 'IOL decentration, Nd:YAG capsulotomy', 'capsule tension ring (CTR', 'cataract surgery']","['PCO', 'post-operative best corrected VA', 'IOL decentration', 'IOL decentration and posterior capsular opacification (PCO', 'Best corrected visual acuity (BCVA', 'BCVA', 'posterior capsule opacification (PCO), and visual acuity (VA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C2939415', 'cui_str': 'Phacodonesis'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C2609312', 'cui_str': 'Intraocular lens decentration'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2609312', 'cui_str': 'Intraocular lens decentration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",,0.0815359,"Nd:YAG posterior capsulotomy rates for PCO were similar in the PEX group when compared to controls (5.3% compared to 3.2%, respectively, p=0.07).","[{'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Haripriya', 'Affiliation': 'Aravind Eye Hospital, Chennai, India.'}, {'ForeName': 'Pradeep Y', 'Initials': 'PY', 'LastName': 'Ramulu', 'Affiliation': 'Wilmer Eye Institute and Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Schehlein', 'Affiliation': 'Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Shekhar', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Shivkumar', 'Initials': 'S', 'LastName': 'Chandrashekharan', 'Affiliation': 'Aravind Eye Hospital, Thirunelveli, India.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Narendran', 'Affiliation': 'Aravind Eye Hospital, Coimbatore, India.'}, {'ForeName': 'Rengaraj', 'Initials': 'R', 'LastName': 'Venkatesh', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Sithiq', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Rengappa', 'Initials': 'R', 'LastName': 'Ramakrishnan', 'Affiliation': 'Aravind Eye Hospital, Thirunelveli, India.'}, {'ForeName': 'Ravilla D', 'Initials': 'RD', 'LastName': 'Ravindran', 'Affiliation': 'Aravind Eye Care System, Madurai, India.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Robin', 'Affiliation': 'Wilmer Eye Institute and Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland, USA; Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA. Electronic address: arobin@glaucomaexpert.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.031']
1387,32624182,Potentiation by sevoflurane of rocuronium-induced neuromuscular block is greater in older than younger adult patients: a randomised controlled trial.,,2020,,['older than younger adult patients'],"['rocuronium-induced neuromuscular block', 'sevoflurane']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]",[],,0.594978,,"[{'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Takagi', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Kitajima', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Matsui', 'Affiliation': 'Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Tokyo, Japan. Electronic address: suzuki.takahiro@nihon-u.ac.jp.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.047']
1388,32624208,Operative treatment of 2-part surgical neck type fractures of the proximal humerus in the elderly: Cement augmented locking plate PHILOS™ vs. proximal humerus nail multiloc®.,"INTRODUCTION


The purpose of this prospective randomized controlled clinical trial was to compare locked plating with intramedullary nailing in the treatment of displaced 2-part surgical neck type proximal humeral fractures in elderly patients.
PATIENTS AND METHODS


Patients ≥60 years of age with a displaced 2-part surgical neck type fracture of the proximal humerus were surgically treated and randomized for either augmented locking plate fixation Group LP or multiplanar intramedullary nailing Group IN. The primary outcome parameter was the Disabilities of the Shoulder, Arm and Hand (DASH) Score after 24 months. Secondary outcome parameters were the age- and gender adjusted Constant Murley Score (CS), the American Shoulder and Elbow Score (ASES), the Oxford Shoulder Score (OSS) and the Short Form 36 (SF-36) after 6 weeks, 3 months, 6 months, 12 and 24 months. Further parameters included the quality of fracture reduction as well as complications and revision surgeries. 60 patients with a mean age of 75±9.8 were included and longitudinally followed over 24 months (follow-up rate: 83.3%).
RESULTS


The mean DASH-Scores at 24 months was 32.6 ± 9.7 points in Group LP versus 37.8 ± 8.3 points in Group IN (p = 0.04). The mean Constant Murley Score at 24 months follow-up was 76.2 ± 7.7 points in Group LP compared to 72 ± 9.1 points in Group IN (p = 0.08). The ASES at 24 months follow-up was 75.1 ± 9 points in Group LP versus to 73.5 ± 8.9 in Group IN (p = 0.51). The OSS at 24 months was 43.7 ± 8.1 in Group LP compared to 38.2 ± 10 in Group IN (p = 0.03). The SF-36 at 24 months was 74.7 ± 12.5 in Group LP versus to 70.9 ± 12.8 in Group IN (p = 0.29). Screw cutting out was observed in n = 2 (6,7%) cases of Group LP, and in none of Group IN (p = 0.49). Revision surgery was necessary in n = 2 (6.7%) cases of Group LP and in two cases of Group IN (6.7%, p = 1).
CONCLUSION


Functional outcomes are similar at 2-years follow-up in locked plating with screw tip augmentation compared to intramedullary nailing. Both implants reached low complication- and revision rates for two-part surgical neck types fractures of the proximal humerus in patients ≥60 years, if anatomic fracture reduction and accurate implant position was obtained.",2020,"Both implants reached low complication- and revision rates for two-part surgical neck types fractures of the proximal humerus in patients ≥60 years, if anatomic fracture reduction and accurate implant position was obtained.","['60 patients with a mean age of 75±9.8 were included and longitudinally followed over 24 months (follow-up rate: 83.3', '2-part surgical neck type fractures of the proximal humerus in the elderly', 'Patients ≥60 years of age with a displaced 2-part surgical neck type fracture of the proximal humerus were surgically treated and randomized for either', 'displaced 2-part surgical neck type proximal humeral fractures in elderly patients']","['locked plating with intramedullary nailing', 'intramedullary nailing', 'augmented locking plate fixation Group LP or multiplanar intramedullary nailing Group IN']","['mean Constant Murley Score', 'Screw cutting out', 'low complication- and revision rates', 'quality of fracture reduction', 'mean DASH-Scores', 'Disabilities of the Shoulder, Arm and Hand', 'DASH', 'age- and gender adjusted Constant Murley Score (CS), the American Shoulder and Elbow Score (ASES), the Oxford Shoulder Score (OSS) and the Short Form 36 (SF-36', 'Revision surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0588209', 'cui_str': 'Bone structure of proximal humerus'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0037006', 'cui_str': 'Fracture of shoulder'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",60.0,0.0407942,"Both implants reached low complication- and revision rates for two-part surgical neck types fractures of the proximal humerus in patients ≥60 years, if anatomic fracture reduction and accurate implant position was obtained.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Helfen', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany. Electronic address: tobias.helfen@med.uni-muenchen.de.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Siebenbürger', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'Fleischhacker', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Gleich', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Böcker', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ockert', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}]",Injury,['10.1016/j.injury.2020.06.026']
1389,32629295,Transcatheter InterAtrial Shunt Device for the treatment of heart failure: Rationale and design of the pivotal randomized trial to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP-HF II).,"BACKGROUND


A randomized, sham-controlled trial in patients with heart failure (HF) and left ventricular ejection fraction (LVEF) ≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD). Whether this hemodynamic effect will translate to an improvement in cardiovascular outcomes and symptoms requires additional study.
STUDY DESIGN AND OBJECTIVES


REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP HF-II) is a multicenter, prospective, randomized, sham-controlled, blinded trial designed to evaluate the clinical efficacy of the IASD in symptomatic HF and elevated left atrial pressures. Up to 608 HF patients age ≥ 40 years with LVEF ≥40%, PCWP ≥25 mm Hg during supine ergometer exercise, and PCWP ≥5 mm Hg higher than right atrial pressure will be randomized 1:1 to the IASD versus sham control. Key exclusion criteria include hemodynamically significant valvular disease, evidence of pulmonary arterial hypertension, and right heart dysfunction. The primary endpoint is a hierarchical composite, analyzed by the Finkelstein-Schoenfeld methodology, that includes (1) cardiovascular mortality or first nonfatal ischemic stroke through 12 months; (2) total (first plus recurrent) HF hospitalizations or healthcare facility visits for intravenous diuretics up to 24 months, analyzed when the last randomized patient completes 12 months of follow-up; and (3) change in Kansas City Cardiomyopathy Questionnaire overall summary score from baseline to 12 months. Follow-up echocardiography will be performed at 6, 12, and 24 months to evaluate shunt flow and cardiac chamber size/function. Patients will be followed for a total of 5 years after the index procedure.
CONCLUSIONS


REDUCE LAP-HF II is designed to evaluate the clinical efficacy of the IASD device in patients with symptomatic HF with elevated left atrial pressure and LVEF ≥40%.",2020,≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD).,"['608 HF patients age', 'Patients with Heart Failure II', 'heart failure', 'patients with heart failure (HF) and left ventricular ejection fraction (LVEF', 'patients with symptomatic HF with elevated left atrial pressure and LVEF ≥40']","['novel transcatheter InterAtrial Shunt Device (IASD', 'LVEF', 'supine ergometer exercise, and PCWP ≥5', 'Transcatheter InterAtrial Shunt Device', 'IASD']","['HF hospitalizations or healthcare facility visits', 'Kansas City Cardiomyopathy Questionnaire overall summary score', 'pulmonary capillary wedge pressure (PCWP', 'Elevated Left Atrial Pressure', 'hierarchical composite, analyzed by the Finkelstein-Schoenfeld methodology, that includes (1) cardiovascular mortality or first nonfatal ischemic stroke through 12 months; (2) total (first plus recurrent']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428877', 'cui_str': 'Atrial pressure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C4544192', 'cui_str': 'Interatrial shunt'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",608.0,0.173581,≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD).,"[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Berry', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mauri', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'NorthShore University Health System, Evanston, IL.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Komtebedde', 'Affiliation': 'Corvia Medical, Tewksbury, MA.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Massaro', 'Affiliation': 'Boston University, Boston, MA.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL. Electronic address: sanjiv.shah@northwestern.edu.'}]",American heart journal,['10.1016/j.ahj.2019.10.015']
1390,32629336,"The effects of a virtual learning environment compared with an individual handheld device on pharmacology knowledge acquisition, satisfaction and comfort ratings.","BACKGROUND


Virtual reality is reported to improve post-intervention knowledge and skills outcomes of health professionals compared to traditional teaching methods or digital online media. However, providing equitable access to high quality virtual reality resources for large, diverse nursing and midwifery student cohorts within multi-campus settings remains challenging.
OBJECTIVES


This study compared the effect on student learning, satisfaction and comfort following exposure to a three-dimensional pharmacology artefact in a virtual facility (CAVE2™) 1  with viewing of the same artefact using a mobile handheld device with stereoscopic lenses attached.
DESIGN


The study used a pretest-posttest design.
SETTING


School of Nursing and Midwifery in a regional university in Southeast Queensland, Australia.
PARTICIPANTS


Two hundred and forty-nine second year undergraduate nursing and midwifery students.
METHODS


Online multiple choice tests were deployed to measure knowledge acquisition. Self-reported satisfaction scores and comfort ratings were collected using questionnaires.
RESULTS


Participants were not disadvantaged in terms of knowledge acquisition by using either CAVE2™ or the mobile handheld visualisation mode (P = 0.977). Significant differences in favour of the CAVE2™ environment were found in between students' satisfaction scores for clinical reasoning (P = 0.013) and clinical learning (P < 0.001) compared to the handheld mode, and there were no significant differences in their satisfaction with debriefing and reflective practice processes (P = 0.377) related to undertaking visualisation activities. A small number of students using handheld devices with stereoscopic lenses reported greater discomfort in relation to the visualisation that negatively impacted their learning (P = 0.001).
CONCLUSION


Three-dimensional artefacts using mobile devices is promising in terms of cost-effectiveness and accessibility for students with restricted access to on-campus teaching modes.",2020,"CONCLUSION


Three-dimensional artefacts using mobile devices is promising in terms of cost-effectiveness and accessibility for students with restricted access to on-campus teaching modes.","['Two hundred and forty-nine second year undergraduate nursing and midwifery students', 'School of Nursing and Midwifery in a regional university in Southeast Queensland, Australia']","['virtual learning environment', 'stereoscopic lenses']","['Self-reported satisfaction scores and comfort ratings', 'satisfaction with debriefing and reflective practice processes', 'knowledge acquisition', 'satisfaction scores for clinical reasoning', 'clinical learning', 'pharmacology knowledge acquisition, satisfaction and comfort ratings']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}]",,0.0701285,"CONCLUSION


Three-dimensional artefacts using mobile devices is promising in terms of cost-effectiveness and accessibility for students with restricted access to on-campus teaching modes.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hanson', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD 4558, Australia. Electronic address: jhanson@usc.edu.au.'}, {'ForeName': 'Patrea', 'Initials': 'P', 'LastName': 'Andersen', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD 4558, Australia. Electronic address: panders1@usc.edu.au.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Dunn', 'Affiliation': 'School Health and Sports Science, Locked Bag 4, Maroochydore DC 4558, Australia. Electronic address: pdunn2@usc.edu.au.'}]",Nurse education today,['10.1016/j.nedt.2020.104518']
1391,32639235,"Bimodal Release Ondansetron Improves Stool Consistency and Symptomatology in Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Trial.","INTRODUCTION


Previous, small studies have suggested that ondansetron has beneficial effects in diarrhea-predominant irritable bowel syndrome (IBS-D). This randomized, double-blind study evaluated the efficacy and safety of daily 12 mg RHB-102, an investigational bimodal release ondansetron tablet, in IBS-D.
METHODS


Men and women with IBS-D by the Rome III criteria, Bristol Stool Scale ≥6 on 2 or more days weekly, and average daily worst pain intensity ≥3/10 were randomized 60:40 to RHB-102 or placebo once daily for 8 weeks. The primary end point was overall stool consistency response for at least 4 of 8 weeks. Secondary end points included overall worst abdominal pain and overall composite response, defined as response on both abdominal pain and stool consistency end points.
RESULTS


Overall stool consistency response rates were 56.0% and 35.3% (RHB-102 vs placebo, P = 0.036) and similar among male and female patients. Overall pain response (50.7% vs 39.2%) and composite response rates (40.0% vs 25.5%) favored RHB-102, although these differences were not statistically significant. Stool consistency response rates were enhanced in patients with baseline C-reactive protein above the median (2.09 mg/L), 59.5%, vs 23.1% (P = 0.009). Overall rates of adverse events were similar, with a higher rate of constipation in RHB-102 patients (13.3% vs 3.9%) that resolved rapidly on withholding treatment.
DISCUSSION


RHB-102 was effective and safe in the treatment of men and women with IBS-D. Baseline C-reactive protein seemed to be predictive of response.",2020,"Overall pain response (50.7% vs 39.2%) and composite response rates (40.0% vs 25.5%) favored RHB-102, although these differences were not statistically significant.","['Men and women with IBS-D by the Rome III criteria, Bristol Stool Scale ≥6 on 2 or more days weekly, and average daily worst pain intensity ≥3/10', 'Diarrhea-Predominant Irritable Bowel Syndrome']","['RHB-102', 'RHB-102 or placebo', 'Bimodal Release Ondansetron', 'daily 12 mg RHB-102', 'ondansetron']","['Stool consistency response rates', 'Stool Consistency and Symptomatology', 'effective and safe', 'rate of constipation', 'Overall pain response', 'efficacy and safety', 'overall worst abdominal pain and overall composite response, defined as response on both abdominal pain and stool consistency end points', 'composite response rates', 'Overall rates of adverse events', 'overall stool consistency response', 'Overall stool consistency response rates']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.720687,"Overall pain response (50.7% vs 39.2%) and composite response rates (40.0% vs 25.5%) favored RHB-102, although these differences were not statistically significant.","[{'ForeName': 'Terry F', 'Initials': 'TF', 'LastName': 'Plasse', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Barton', 'Affiliation': 'Arkansas Gastroenterology, PA, North Little Rock Arkansas, USA.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Davidson', 'Affiliation': 'New Phase Research & Development, Knoxville, Tennessee, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Abramson', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Kalfus', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Fathi', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'Gilead', 'Initials': 'G', 'LastName': 'Raday', 'Affiliation': 'RedHill Biopharma, Tel Aviv, Israel.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Harris', 'Affiliation': 'Middleburg Consultants, Takoma Park, Maryland, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000727']
1392,32488427,Physiologically Based Dissolution Testing in a Drug Development Process-a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions.,"Development of generic extended-release (ER) formulations is challenging. Especially under fed conditions, the risk of failure in bioequivalence trials is high because of long gastric residence times and susceptibility to food effects. We describe the development of a generic trazodone ER formulation that was aided with a biorelevant dissolution evaluation. Trazodone hydrochloride 300-mg monolithic matrix tablets were dissolved both in USP and EMA compliant conditions and in the StressTest device that simulated both physicochemical and mechanical conditions of the gastrointestinal passage. The final formulation was tested against the originator, Trittico XR 300 mg, in a randomized cross-over bioequivalence trial with 44 healthy volunteers, in agreement with EMA guidelines. Initially developed formulations dissolved trazodone similarly to the originator under standard conditions (f 2  factor above 50), but their dissolution kinetics differed significantly in the biorelevant tests. The formulation was optimized by the addition of low-viscosity hypromellose and mannitol. The final formulation was approved for the bioequivalence trial. Calculated C max  were 1.92 ± 0.77 and 1.92 ± 0.63 [μg/mL], AUC 0-t  were 27.46 ± 8.39 and 29.96 ± 9.09 [μg∙h/mL], and AUC 0-∞  were 28.22 ± 8.91 and 30.82 ± 9.41 [μg∙h/mL] for the originator and test formulations, respectively. The 90% confidence intervals of all primary pharmacokinetic parameters fell within the 80-125% range. In summary, biorelevant dissolution tests supported successful development of a generic trazodone ER formulation pharmaceutically equivalent with the originator under fed conditions. Employment of biorelevant dissolution tests may decrease the risk of failure in bioequivalence trials of ER formulations.",2020,"Initially developed formulations dissolved trazodone similarly to the originator under standard conditions (f 2  factor above 50), but their dissolution kinetics differed significantly in the biorelevant tests.",['44 healthy volunteers'],"['trazodone', 'generic trazodone ER formulation', 'Trazodone ER Formulations', 'Trazodone hydrochloride', 'low-viscosity hypromellose and mannitol']",['dissolution kinetics'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0282369', 'cui_str': 'Trazodone hydrochloride'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0063242', 'cui_str': 'hypromellose'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}]",44.0,0.107498,"Initially developed formulations dissolved trazodone similarly to the originator under standard conditions (f 2  factor above 50), but their dissolution kinetics differed significantly in the biorelevant tests.","[{'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Danielak', 'Affiliation': 'Department of Physical Pharmacy and Pharmacokinetics, Faculty of Pharmacy, Poznan University of Medical Sciences, 6 Święcickiego st, 60-781, Poznań, Poland. danielak@ump.edu.pl.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Milanowski', 'Affiliation': 'Department of Pharmaceutical Technology, Faculty of Pharmacy, Poznan University of Medical Sciences, 6 Grunwaldzka st, 60-780, Poznań, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Wentowski', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nogowska', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Kątny', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rogowski', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Konwicki', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Puk', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Pieczuro', 'Affiliation': 'Biofarm Sp. z o.o, 13 Wałbrzyska st, 60-198, Poznań, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Bawiec', 'Affiliation': 'Institute of Computer Engineering, Control and Robotics, Wroclaw University of Technology, 27 Wybrzeże Wyspańskiego st, 50-370, Wrocław, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Garbacz', 'Affiliation': 'Physiolution GmbH, Walther-Rathenau Strasse 49a, 17489, Greifswald, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Lulek', 'Affiliation': 'Department of Pharmaceutical Technology, Faculty of Pharmacy, Poznan University of Medical Sciences, 6 Grunwaldzka st, 60-780, Poznań, Poland.'}]",AAPS PharmSciTech,['10.1208/s12249-020-01662-8']
1393,32593069,Affective responses to climbing exercises in children and adolescents during in-patient treatment for mental health disorders a pilot study on acute effects of different exercise interventions.,"The aim of the present study was to compare acute effects of a climbing intervention (CI) on affective responses with a different exercise intervention (swimming, SI) and an occupational therapy intervention (OTI) in children and adolescents during in-patient treatment for mental health disorders. The following study was designed as a cross-over study. Participants completed three single 60 min interventions of CI, SI and OTI. Affective responses were assessed pre and post intervention and at 20 and 40 min during intervention. The sample consisted of 33 children and adolescents in mental-health inpatient care (ᴓage: 13.3 ± 2.2 years, ♀=39.4%). A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144. Repeated measures ANOVAs revealed a significant time by intervention effect for affective valence (p=.011, eta²=0.09), but not for perceived activation, favouring CI over SI and OCT between pre-test and the first 20 or 40 min, respectively. All interventions showed similar effects on affective responses pre to post interventions. CI seems to increase affective valence more strongly during intervention compared to SI and OTI. The present results may have implications for therapy adherence and acute emotion regulation in children and adolescent in-patients with mental health disorders.",2020,"A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144.","['children and adolescent in-patients with mental health disorders', '33 children and adolescents in mental-health inpatient care (ᴓage: 13.3\xa0±\xa02.2 years, ♀=39.4', 'children and adolescents during in-patient treatment for mental health disorders']","['exercise intervention (swimming, SI) and an occupational therapy intervention (OTI', 'exercise interventions', 'climbing exercises', 'climbing intervention (CI']","['perceived activation, favouring CI over SI and OCT', 'affective valence', 'Affective responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0561942', 'cui_str': 'Does climb'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0561942', 'cui_str': 'Does climb'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]",33.0,0.0311106,"A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144.","[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Frühauf', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria. Electronic address: anika.fruehauf@uibk.ac.at.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Niedermeier', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Sevecke', 'Affiliation': 'Department of Psychiatry Psychotherapy and Psychosomatics in childhood and adolescence, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Haid-Stecher', 'Affiliation': 'Department of Psychiatry Psychotherapy and Psychosomatics in childhood and adolescence, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Albertini', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Richter', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schipflinger', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kopp', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}]",Psychiatry research,['10.1016/j.psychres.2020.113245']
1394,32601120,Deep brain stimulation in early-stage Parkinson disease: Five-year outcomes.,"OBJECTIVE


To report 5-year outcomes from the subthalamic nucleus (STN) deep brain stimulation (DBS) in early-stage Parkinson disease (PD) pilot clinical trial.
METHODS


The pilot was a prospective, single-blind clinical trial that randomized patients with early-stage PD (Hoehn & Yahr II off medications) to receive bilateral STN DBS plus optimal drug therapy (ODT) vs ODT alone (IDEG050016, NCT0282152, IRB040797). Participants who completed the 2-year trial participated in this observational follow-up study, which included annual outpatient visits through 5 years. This analysis includes 28 patients who were taking PD medications for 6 months to 4 years at enrollment. Outcomes were analyzed using both proportional odds logistic regression and linear mixed effects models.
RESULTS


Early STN DBS + ODT participants required lower levodopa equivalent daily doses ( p  = 0.04, β = -240 mg, 95% confidence interval [CI] -471 to -8) and had 0.06 times the odds of requiring polypharmacy at 5 years compared to early ODT participants ( p  = 0.01, odds ratio [OR] 0.06, 95% CI 0.00 to 0.65). The odds of having worse rest tremor for early STN DBS + ODT participants were 0.21 times those of early ODT participants ( p  < 0.001, OR 0.21, 95% CI 0.09 to 0.45). The safety profile was similar between groups.
CONCLUSIONS


These results suggest that early DBS reduces the need for and complexity of PD medications while providing long-term motor benefit over standard medical therapy. Further investigation is warranted, and the Food and Drug Administration has approved the conduct of a prospective, multicenter, pivotal clinical trial of DBS in early-stage PD (IDEG050016).
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that DBS implanted in early-stage PD decreases the risk of disease progression and polypharmacy compared to optimal medical therapy alone.",2020,"RESULTS


Early STN DBS+ODT subjects required lower levodopa equivalent daily doses (P=0.04, β = -240mg, 95%CI: -471 to -8) and had 0.06 times the odds of requiring polypharmacy at five years compared to early ODT subjects (P=0.01, OR=0.06, 95%CI: 0.00 to 0.65).","['Subjects who completed the two-year trial participated in this observational follow-up study which included annual outpatient visits through five years', ""Early-Stage Parkinson's Disease"", '28 subjects who were taking PD medications six months-four years at enrollment', ""early-stage Parkinson's disease (PD""]","['subthalmic nucleus (STN) deep brain stimulation (DBS', 'bilateral STN DBS plus optimal drug therapy (ODT) versus ODT']",['safety profile'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.127564,"RESULTS


Early STN DBS+ODT subjects required lower levodopa equivalent daily doses (P=0.04, β = -240mg, 95%CI: -471 to -8) and had 0.06 times the odds of requiring polypharmacy at five years compared to early ODT subjects (P=0.01, OR=0.06, 95%CI: 0.00 to 0.65).","[{'ForeName': 'Mallory L', 'Initials': 'ML', 'LastName': 'Hacker', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD. Mallory.Hacker@vumc.org.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Turchan', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Heusinkveld', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Amanda D', 'Initials': 'AD', 'LastName': 'Currie', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Millan', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Molinari', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Konrad', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Davis', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Fenna T', 'Initials': 'FT', 'LastName': 'Phibbs', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Cannard', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Charles', 'Affiliation': 'From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.'}]",Neurology,['10.1212/WNL.0000000000009946']
1395,32601123,Does screening for adverse effects improve health outcomes in epilepsy? A randomized trial.,"OBJECTIVE


To determine whether systematic screening for adverse effects of antiepileptic drugs (AEDs) reduces toxicity burden and improves health-related quality of life in patients with epilepsy.
METHODS


Consecutive patients with uncontrolled seizures aged ≥16 years and a high Adverse Event Profile (AEP) score were randomized to 2 groups and followed up for 18 months at 11 referral centers. AEP scores were made available to treating physicians at all visits in the intervention group, but not in the control group. Co-primary endpoints were changes in AEP scores and Quality of Life Inventory for Epilepsy-31 (QOLIE-31) scores.
RESULTS


Of 809 enrolled patients able to complete the AEP questionnaire, 222 had AEP scores ≥45 and were randomized to the intervention (n = 111) or control group (n = 111). A total of 206 patients completed the 18-month follow-up. Compared with baseline, AEP scores decreased on average by 7.2% at 6 months, 12.1% at 12 months, and 13.8% at 18 months in the intervention group ( p  < 0.0001), and by 7.7% at 6 months, 9.2% at 12 months, and 12.0% at 18 months in controls ( p  < 0.0001). QOLIE-31 scores also improved from baseline to final visit, with a mean 20.7% increase in the intervention group and a mean 24.9% increase in the control group ( p  < 0.0001). However, there were no statistically significant differences in outcomes between groups for the 2 co-primary variables.
CONCLUSIONS


Contrary to findings from a previous study, systematic screening for adverse effects of AEDs using AEP scores did not lead to a reduced burden of toxicity over usual physician treatment.
ITALIAN MEDICINES AGENCY AIFA IDENTIFIER


FARM52K2WM_003.
CLINICALTRIALSGOV IDENTIFIER


NCT03939507 (registered retrospectively in 2019; the study was conducted during the 2006-2009 period and registration of clinical trials was not a widely established practice when this study was initiated).
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that the additional collection of formal questionnaires regarding adverse effects of AEDs does not reduce toxicity burden over usual physician treatment.",2020,"AEP scores were made available to treating physicians at all visits in the intervention group, but not in the control group.","['206 patients completed the 18-month follow-up', 'Consecutive patients with uncontrolled seizures aged ≥16 years and a high Adverse Event Profile (AEP) score were randomized to 2 groups and followed up for 18 months at 11 referral centers', '809 enrolled patients able to complete the AEP questionnaire, 222 had AEP scores ≥45', 'patients with epilepsy', 'NCT03939507 (registered retrospectively in 2019; the study was conducted during the 2006-2009 period and registration of clinical trials was not a widely established practice when this study was initiated']",['antiepileptic drugs (AEDs'],"['toxicity burden', 'toxicity', 'toxicity burden and improves health-related quality of life', 'AEP scores and Quality of Life Inventory for Epilepsy-31 (QOLIE-31) scores', 'QOLIE-31 scores', 'AEP scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0443211', 'cui_str': 'Established'}]","[{'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]",809.0,0.161817,"AEP scores were made available to treating physicians at all visits in the intervention group, but not in the control group.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Franco', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy. valentina.franco@unipv.it.'}, {'ForeName': 'Maria Paola', 'Initials': 'MP', 'LastName': 'Canevini', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Giovambattista', 'Initials': 'G', 'LastName': 'De Sarro', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Fattore', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Fedele', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Carlo Andrea', 'Initials': 'CA', 'LastName': 'Galimberti', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Gatti', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'La Neve', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Rosati', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Luigi Maria', 'Initials': 'LM', 'LastName': 'Specchio', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Striano', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tinuper', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Perucca', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000009880']
1396,32608120,Effect of recorded maternal voice on emergence agitation in children undergoing bilateral ophthalmic surgery: A randomised controlled trial.,"AIM


This study was designed to investigate whether the playing-back of the recorded maternal voice through the headphones to children undergoing bilateral ophthalmic surgery has clinical effects on the incidence of emergence agitation, and the anaesthesia recovery course.
METHODS


In this prospective, blinded and randomised study, 127 children, aged 2-8 years and undergoing bilateral ophthalmic surgery were randomly allocated to one of the two groups: group T (treatment group, listening to recorded mother's voice via headphones) or group C (control group, wearing headphones without auditory stimuli). The primary outcome was the incidence of emergence agitation, and the secondary outcomes were the awakening time, and the post-anaesthesia care unit (PACU) stay time.
RESULTS


Children in the group of listening recorded mother's voice exhibited significantly low incidence of emergence agitation compared with those in the control group (32.8 vs. 55.6%; odds ratio (95% confidence interval): 0.39(0.19-0.80); P = 0.010). The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048). As results, the group T had significantly less PACU stay time with early discharge than the group C did (29.7 (12.1) vs. 34.8 (14.1); P = 0.031).
CONCLUSIONS


Recorded mother's voice is an efficient method to reduce emergence agitation in children undergoing bilateral ophthalmic surgery with sevoflurane anaesthesia. Also, patients woke faster and PACU stay time was shorter in the mother's voice group as compared with the control group.",2020,The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048).,"['children undergoing bilateral ophthalmic surgery', '127 children, aged 2-8\u2009years and undergoing bilateral ophthalmic surgery', 'children undergoing bilateral ophthalmic surgery with sevoflurane anaesthesia']","[""group T (treatment group, listening to recorded mother's voice via headphones) or group C (control group, wearing headphones without auditory stimuli"", 'recorded maternal voice']","['awakening time, and the post-anaesthesia care unit (PACU) stay time', 'emergence agitation', 'awakening time', 'PACU stay time with early discharge', 'PACU stay time', 'incidence of emergence agitation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0441067', 'cui_str': 'Earphones'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}]","[{'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",127.0,0.285404,The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048).,"[{'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ma-Zhong', 'Initials': 'MZ', 'LastName': 'Zhang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Zhe-Zhe', 'Initials': 'ZZ', 'LastName': 'Peng', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Pei-Pei', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yan-Ting', 'Initials': 'YT', 'LastName': 'Wang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ji-Jian', 'Initials': 'JJ', 'LastName': 'Zheng', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Jun-Zheng', 'Initials': 'JZ', 'LastName': 'Wu', 'Affiliation': ""Department of Anaesthesia and Paediatrics, Cincinnati Children's Hospital Medical Centre, Cincinnati, Ohio, United States.""}]",Journal of paediatrics and child health,['10.1111/jpc.14948']
1397,32603956,Leptin mediates improvements in cognitive function following treatment with infliximab in adults with bipolar depression.,"A potential role for leptin in the pathophysiology of bipolar disorder (BD) has been proposed. We recently investigated the effects of the tumor necrosis factor-alpha (TNF-α) antagonist infliximab in individuals with bipolar depression. Leptin is known to interact with the TNF-α system. Herein, we aimed to explore infliximab's effects on leptin and its relationship with brain structure and function. Sixty adults with bipolar depression were enrolled in this randomized, double-blind, 12-week clinical trial of adjunctive infliximab (n = 29) and saline control (n = 31), which were administered intravenously at weeks 0, 2, and 6. Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR) 1 and 2 were assessed at weeks 0, 2, 6, and 12. We observed a significant decrease in leptin levels in infliximab-treated patients, relative to placebo. Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels. Changes in sTNR2 levels at week 6 significantly determined changes in leptin at week 12 in infliximab-, but not placebo-treated participants. Improvements in verbal memory and increases in global cortical volume were associated with reduction in leptin levels in the treatment group. Mediation analysis indicated that cognitive improvement in infliximab-treated patients was mediated by reductions in leptin levels, which in its turn were determined by decreases in sTNR2 levels. In conclusion, infliximab treatment reduced plasma leptin levels in individuals with BD, through modulation of sTNFR2. Decreases in leptin signaling were associated with an increase in global cortical volume and better performance in a verbal memory task.",2020,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","['Sixty adults with bipolar depression', 'individuals with BD', 'adults with bipolar depression', 'individuals with bipolar depression']","['Leptin', 'saline control', 'adjunctive infliximab', 'infliximab', 'Infliximab', 'tumor necrosis factor-alpha (TNF-α) antagonist infliximab', 'placebo']","['leptin', 'cognitive improvement', 'global cortical volume and better performance in a verbal memory task', 'cognitive function', 'Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR', 'verbal memory', 'plasma leptin levels', 'global cortical volume', 'leptin signaling', 'leptin levels', 'TNF-α and sTNFR2', 'sTNR2 levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.149116,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","[{'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Electronic address: rodrigo.mansur@uhn.ca.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Zihang', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Carmona', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Shekotikhina', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; University of Ottawa, Department of Psychiatry, Ottawa, ON, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Iacobucci', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Rodrigues', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Nasri', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Rashidian', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Kingston General Hospital, Providence Care Hospital, Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada.""}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104779']
1398,32610246,Structure and process associated with the efficiency of intensive care units in low-resource settings: An analysis of the CHECKLIST-ICU trial database.,"PURPOSE


Characteristics of structure and process impact ICU performance and the outcomes of critically ill patients. We sought to identify organizational characteristics associated with efficient ICUs in low-resource settings.
MATERIALS AND METHODS


This is a secondary analysis of a multicenter cluster-randomized clinical trial in Brazil (CHECKLIST-ICU). Efficient units were defined by standardized mortality ratio (SMR) and standardized resource use (SRU) lower than the overall medians and non-efficient otherwise. We used a regularized logistic regression model to evaluate associations between organizational factors and efficiency.
RESULTS


From 118 ICUs (13,635 patients), 47 units were considered efficient and 71 non-efficient. Efficient units presented lower incidence rates (median[IQR]) of central line-associated bloodstream infections (4.95[0.00-22.0] vs 6.29[0.00-25.6], p = .04), utilization rates of mechanical ventilation (0.41[0.07-0.73] vs 0.58[0.19-0.82], p < .001), central venous catheter (0.67[0.15-0.98] vs 0.78[0.33-0.98], p = .04), and indwelling urinary catheter (0.62[0.22-0.95] vs 0.76[0.32-0.98], p < .01) than non-efficient units. The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs.
CONCLUSIONS


In low-resource settings, active surveillance of nosocomial infections and the utilization of invasive devices were associated with efficiency, supporting the management and evaluation of performance indicators as a starting point for improvement in ICU.",2020,"The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs.
","['critically ill patients', 'low-resource settings', 'From 118 ICUs (13,635 patients']",[],"['utilization of central venous catheters', 'utilization rates of mechanical ventilation', 'central venous catheter', 'standardized mortality ratio (SMR) and standardized resource use (SRU', 'incidence rates (median[IQR]) of central line-associated bloodstream infections', 'indwelling urinary catheter']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C4517542', 'cui_str': '118'}]",[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0521197', 'cui_str': 'Indwelling urinary catheter'}]",,0.219858,"The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs.
","[{'ForeName': 'Leonardo S L', 'Initials': 'LSL', 'LastName': 'Bastos', 'Affiliation': 'Department of Industrial Engineering, Pontifical Catholic University of Rio de Janeiro (PUC-Rio), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'Department of Industrial Engineering, Pontifical Catholic University of Rio de Janeiro (PUC-Rio), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': ""Research Institute, Hospital do Coração (HCor), São Paulo, Brazil; D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.""}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute, Hospital do Coração (HCor), São Paulo, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.'}, {'ForeName': 'Jorge I F', 'Initials': 'JIF', 'LastName': 'Salluh', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.""}, {'ForeName': 'Fernando A', 'Initials': 'FA', 'LastName': 'Bozza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil; Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, RJ, Brazil. Electronic address: fernando.bozza@ini.fiocruz.br.""}]",Journal of critical care,['10.1016/j.jcrc.2020.06.008']
1399,32619648,Impact of compliance to chemoradiation on long-term outcomes in squamous cell carcinoma of the anus: results of a post hoc analysis from the randomised phase III ACT II trial.,"BACKGROUND


Concurrent chemoradiation is standard-of-care for patients with squamous cell carcinoma of the anus. Poor compliance to chemotherapy, radiotherapy treatment interruptions and unplanned breaks may impact adversely on long-term outcomes.
METHODS


The ACT II trial recruited 940 patients with localised squamous cell carcinoma of the anus, and assigned patients to mitomycin (week 1) or cisplatin (weeks 1 and 5), with fluorouracil (weeks 1 and 5) and radiotherapy (50.4 Gy in 28 fractions over 38 days). This post hoc analysis examined the association between baseline factors (age, gender, site, T stage and N stage), and compliance to treatment (radiotherapy and chemotherapy), and their effects on locoregional failure-free survival, progression-free survival (PFS) and overall survival (OS). Compliance was categorised into groups. Radiotherapy: six groups according to total dose and overall treatment time (OTT). Chemotherapy: three groups (A = per-protocol; B = dose reduction or delay; C = omitted).
RESULTS


A total of 931/940 patients were assessable for radiotherapy and 936 for chemotherapy compliance. Baseline glomerular filtration rate <60 ml/min and cisplatin were significantly associated with poor week 5 compliance to chemotherapy (P = 0.003 and 0.02, respectively). Omission of week 5 chemotherapy was associated with significantly worse locoregional failure-free survival [hazard ratio (HR) 2.53 (1.33-4.82) P = 0.005]. Dose reductions/delays or omission of week 5 chemotherapy were associated with significantly worse PFS {HR: 1.56 [95% confidence interval (CI): 1.18-2.06], P = 0.002 and HR: 2.39 (95% CI: 1.44-3.98), P = 0.001, respectively} and OS [HR: 1.92 (95% CI: 1.41-2.63), P < 0.001 and HR: 2.88 (95% CI: 1.63-5.08), P < 0.001, respectively]. Receiving the target radiotherapy dose in >42 days is associated with worse PFS and OS [HR: 1.72 (95% CI: 1.17-2.54), P =0.006].
CONCLUSION


Poor compliance to chemotherapy and radiotherapy were associated with worse locoregional failure-free survival, PFS and OS. Treatment interruptions should be minimised, and OTT and total dose maintained.
CLINICAL TRIAL NUMBER


ISRCTN 26715889.",2020,"<60 mL/min and cisplatin were significantly associated with poor week 5 compliance to chemotherapy (p 0.003 and 0.02, respectively).","['patients with squamous cell carcinoma of the anus (SCCA', '940 patients with localized SCCA, and assigned patients to', 'squamous cell carcinoma of the anus', '931/940 patients were evaluable for radiotherapy and 936 for chemotherapy compliance']","['Chemotherapy', 'chemotherapy and radiotherapy', 'fluorouracil', 'chemotherapy, radiotherapy', 'cisplatin', 'mitomycin', 'radiotherapy (50·4Gy', 'Radiotherapy']","['worse PFS and OS', 'total dose (TD) and overall treatment time (OTT', 'loco-regional failure-free survival (LRFFS), progression-free survival (PFS) and overall survival (OS', 'Baseline Glomerular filtration rate (GR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1412036', 'cui_str': 'Anal squamous cell carcinoma'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",940.0,0.148641,"<60 mL/min and cisplatin were significantly associated with poor week 5 compliance to chemotherapy (p 0.003 and 0.02, respectively).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Mount Vernon Centre for Cancer Treatment, Mount Vernon Hospital, Northwood, UK. Electronic address: rob.glynnejones@nhs.net.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Meadows', 'Affiliation': 'Cancer Research UK & University College London Cancer Trials Centre, UCL, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'Cancer Research UK & University College London Cancer Trials Centre, UCL, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'Oxford Cancer & Haematology Centre, Oxford University Hospitals, Oxford, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sebag-Montefiore', 'Affiliation': 'University of Leeds, Leeds Cancer Centre, Leeds, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.06.012']
1400,32621073,"Conscious perception and the modulatory role of dopamine: no effect of the dopamine D2 agonist cabergoline on visual masking, the attentional blink, and probabilistic discrimination.","RATIONALE


Conscious perception is thought to depend on global amplification of sensory input. In recent years, striatal dopamine has been proposed to be involved in gating information and conscious access, due to its modulatory influence on thalamocortical connectivity.
OBJECTIVES


Since much of the evidence that implicates striatal dopamine is correlational, we conducted a double-blind crossover pharmacological study in which we administered cabergoline-a dopamine D2 agonist-and placebo to 30 healthy participants. Under both conditions, we subjected participants to several well-established experimental conscious-perception paradigms, such as backward masking and the attentional blink task.
RESULTS


We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
CONCLUSIONS


Our results cast doubt on a causal role for dopamine in visual perception. It remains an open possibility that dopamine has causal effects in other tasks, perhaps where perceptual uncertainty is more prominent.",2020,"We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
",['30 healthy participants'],"['cabergoline-a dopamine D2 agonist-and placebo', 'dopamine D2 agonist cabergoline', 'backward masking and the attentional blink task', 'cabergoline', 'dopamine']","['visual masking, the attentional blink, and probabilistic discrimination']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0107994', 'cui_str': 'cabergoline'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C1955945', 'cui_str': 'Attentional Blink'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1955945', 'cui_str': 'Attentional Blink'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",30.0,0.0541971,"We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline.
","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Boonstra', 'Affiliation': 'Department of Experimental and Applied Psychology, Institute for Brain and Behavior Amsterdam (iBBA) Vrije Universiteit, Amsterdam, Netherlands. evertboonstra@gmail.com.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'van Schouwenburg', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam Brain and Cognition (ABC), Amsterdam, Netherlands.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Seth', 'Affiliation': 'Department of Informatics Sackler Centre for Consciousness Science, University of Sussex, Brighton, BN1 9QJ, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Zantvoord', 'Affiliation': 'Department of Child and Adolescent Psychiatry, The Bascule, Academic Centre for Child and Adolescent Psychiatry Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Kemper', 'Affiliation': 'Department of Pharmacy, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Lansink', 'Affiliation': 'Swammerdam Institute for Life Sciences, University of Amsterdam, Amsterdam Brain and Cognition (ABC), Amsterdam, Netherlands.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Slagter', 'Affiliation': 'Department of Experimental and Applied Psychology, Institute for Brain and Behavior Amsterdam (iBBA) Vrije Universiteit, Amsterdam, Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05579-9']
1401,32632657,Correction to: Prebiotic effect of inulin‑type fructans on faecal microbiota and short‑chain fatty acids in type 2 diabetes: a randomised controlled trial.,The original version of this article unfortunately contained a mistake. The presentation of Fig. 4 was incorrect.,2020,The original version of this article unfortunately contained a mistake.,['type 2 diabetes'],['inulin‑type fructans'],['faecal microbiota and short‑chain fatty acids'],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0016743', 'cui_str': 'Levans'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]",,0.0311723,The original version of this article unfortunately contained a mistake.,"[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Birkeland', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway. eline.birkeland@ous-hf.no.'}, {'ForeName': 'Sedegheh', 'Initials': 'S', 'LastName': 'Gharagozlian', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kåre I', 'Initials': 'KI', 'LastName': 'Birkeland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Valeur', 'Affiliation': 'Department of Gastroenterology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Måge', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Rud', 'Affiliation': 'Nofima-Norwegian Institute of Food, Fisheries and Aquaculture Research, Ås, Norway.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Aas', 'Affiliation': 'Section of Nutrition and Dietetics, Division of Medicine, Department of Clinical Service, Oslo University Hospital, Oslo, Norway.'}]",European journal of nutrition,['10.1007/s00394-020-02314-0']
1402,32628922,"Incidence and Outcome of Uveitic Glaucoma in Eyes With Intermediate, Posterior, or Panuveitis Followed up to 10 Years After Randomization to Fluocinolone Acetonide Implant or Systemic Therapy.","PURPOSE


To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, ""implant"") therapy.
DESIGN


Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort.
METHODS


Patients with intermediate, posterior, or panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome.
RESULTS


Among 405 uveitic at-risk eyes of 232 patients (median follow-up = 6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant on implantation) developed glaucoma (hazard ratio [HR] = 5.9, 95% confidence interval [CI] 3.2, 10.8; P < .001). Adjustment for intraocular pressure (IOP) elevation during follow-up only partially mitigated the association of implant treatment with glaucoma incidence: HR = 3.1 (95% CI 1.6, 6.0); P = .001. Among 112 eyes of 83 patients developing glaucoma, the 5-year cumulative incidence following diagnosis of sustained (2 or more consecutive visits) worsening of mean deviation by ≥6 dB was 20% (95% CI 12%, 33%); 5-year cumulative incidence of sustained worsening of cup-to-disc ratio by ≥0.2 was 26% (95% CI 17%, 39%).
CONCLUSIONS


The implant has substantially higher risk of glaucoma than systemic therapy, a difference not entirely explained by posttreatment IOP elevation. Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management, some glaucoma worsened. Uveitis cases should be monitored carefully for IOP elevation and glaucoma indefinitely.",2020,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","['eyes with intermediate, posterior, and panuveitis managed with systemic or', '112 eyes of 83 patients developing glaucoma', 'Multicenter Uveitis Steroid Treatment (MUST', ' Patients with intermediate, posterior or panuveitis randomized to', 'eyes with intermediate, posterior or panuveitis followed up to 10 years after randomization to']","['systemic therapy', 'implant or systemic therapy (corticosteroid plus immunosuppression', 'fluocinolone acetonide', 'fluocinolone acetonide implant or systemic therapy']","['IOP elevation', 'sustained worsening of cup-to-disc ratio', 'uveitic glaucoma']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030343', 'cui_str': 'Panuveitis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}]","[{'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0423471', 'cui_str': 'Optic cup/disc ratio'}, {'cui': 'C1281939', 'cui_str': 'Uveitic glaucoma'}]",83.0,0.167216,"Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management some glaucoma worsened.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Kempen', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA; Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA; The MyungSung Christian Medical Center (MCM) Eye Unit, MCM General Hospital and MyungSung Medical School, Addis Ababa, Ethiopia. Electronic address: john_kempen@meei.harvard.edu.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Van Natta', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Friedman', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Altaweel', 'Affiliation': 'Fundus Photograph Reading Center, Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin, USA.'}, {'ForeName': 'Husam', 'Initials': 'H', 'LastName': 'Ansari', 'Affiliation': 'Ophthalmology Consultants of Boston, Boston, Massachusetts, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dunn', 'Affiliation': 'Mid-Atlantic Retina, Philadelphia, Pennsylvania, USA; The Wills Eye Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Elner', 'Affiliation': 'The Kellogg Eye Center, Department of Ophthalmology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'The Royal Victorian Eye and Ear Hospital, Melbourne, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Jabs', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; The Johns Hopkins University School of Medicine Wilmer Eye Institute, Baltimore, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.038']
1403,32649760,"Micronutrient supplementation of lactating Guatemalan women acutely increases infants' intake of riboflavin, thiamin, pyridoxal, and cobalamin, but not niacin, in a randomized crossover trial.","BACKGROUND


Maternal supplementation during lactation could increase milk B-vitamin concentrations, but little is known about the kinetics of milk vitamin responses.
OBJECTIVES


We compared acute effects of maternal lipid-based nutrient supplement (LNS) consumption (n = 22 nutrients, 175%-212% of the RDA intake for the nutrients examined), as a single dose or at spaced intervals during 8 h, on milk concentrations and infant intake from milk of B-vitamins.
METHODS


This randomized crossover trial in Quetzaltenango, Guatemala included 26 mother-infant dyads 4-6 mo postpartum who were randomly assigned to receive 3 treatments in a random order: bolus 30-g dose of LNS (Bolus); 3 × 10-g doses of LNS (Divided); and no LNS (Control), with control meals. Mothers attended three 8-h visits during which infant milk consumption was measured and milk samples were collected at every feed. Infant intake was assessed as $\mathop \sum \nolimits_{i\ = \ 1}^n ( {{\rm{milk\ volum}}{{\rm{e}}_{{\rm{feed\ }}n}} \times \ {\rm{nutrient\ concentratio}}{{\rm{n}}_{{\rm{feed}}\ n}}} )$ over 8 h.
RESULTS


Maternal supplementation with the Bolus or Divided dose increased least-squares mean (95% CI) milk and infant intakes of riboflavin [milk: Bolus: 154.4 (138.2, 172.5) μg · min-1 · mL-1; Control: 84.5 (75.8, 94.3) μg · min-1 · mL-1; infant: Bolus: 64.5 (56.1, 74.3) μg; Control: 34.5 (30.0, 39.6) μg], thiamin [milk: Bolus: 10.9 (10.1, 11.7) μg · min-1 · mL-1; Control: 7.7 (7.2, 8.3) μg · min-1 · mL-1; infant: Bolus: 5.1 (4.4, 6.0) μg; Control: 3.4 (2.9, 4.0) μg], and pyridoxal [milk: Bolus: 90.5 (82.8, 98.9) μg · min-1 · mL-1; Control: 60.8 (55.8, 66.3) μg · min-1 · mL-1; infant: Bolus: 39.4 (33.5, 46.4) μg; Control: 25.0 (21.4, 29.2) μg] (all P < 0.001). Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018) μg, P = 0.001] compared with Control. Niacin was unaffected.
CONCLUSIONS


Maternal supplementation with LNS as a Bolus or Divided dose was similarly effective at increasing milk riboflavin, thiamin, and pyridoxal and infant intakes, whereas only the Bolus dose increased cobalamin. Niacin was unaffected in 8 h. This trial was registered at clinicaltrials.gov as NCT02464111.",2020,"Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018)","['lactating Guatemalan women acutely increases infants', 'Quetzaltenango, Guatemala included 26 mother-infant dyads 4-6 mo postpartum']","['Niacin', 'LNS (Divided); and no LNS (Control), with control meals', 'maternal lipid-based nutrient supplement (LNS) consumption', 'LNS (Bolus); 3\xa0×', 'Micronutrient supplementation']","[' intake of riboflavin, thiamin, pyridoxal, and cobalamin', 'Infant intake', 'milk B-vitamin concentrations', ' 1}^n ( {{\\rm{milk\\ volum}}{{\\rm{e}}_{{\\rm{feed\\ }}n}} \\times \\ {\\rm{nutrient\\ concentratio}}{{\\rm{n}}_{{\\rm{feed}}\\ n}}} ', 'milk riboflavin, thiamin, and pyridoxal and infant intakes', 'least-squares mean']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023374', 'cui_str': 'Lesch-Nyhan syndrome'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0034263', 'cui_str': 'Pyridoxal'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.372535,"Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018)","[{'ForeName': 'Juliana A', 'Initials': 'JA', 'LastName': 'Donohue', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Solomons', 'Affiliation': 'Center for Studies of Sensory Impairment, Aging and Metabolism, Guatemala City, Guatemala.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hampel', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Shahab-Ferdows', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Mónica N', 'Initials': 'MN', 'LastName': 'Orozco', 'Affiliation': 'Center for Atitlán Studies, Universidad del Valle de Guatemala, Sololá, Guatemala.'}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa147']
1404,32652462,Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder.,"BACKGROUND


Medication adherence is crucial for improving clinical outcomes in the treatment of patients. We evaluate the effect of short message service (SMS) reminder on medication adherence and serum hormones in patients with breast cancer on aromatase inhibitors.
METHODS


An open-label, multi-centre, prospective randomised controlled trial of SMS versus Standard Care was conducted. Medication adherence was assessed via self-report using the Simplified Medication Adherence Questionnaire at baseline, 6 month, and 1 year. Androstenedione, estradiol, and estrone were measured at baseline and 1 year. The χ 2  test and mixed effects logistic regression was performed to compare medication adherence between groups. Difference in androstenedione and estrone levels were assessed using analysis of covariance, whereas χ 2  test and logistic regression was used for estradiol. Analysis was based on intention-to-treat.
RESULTS


A total of 244 patients were randomised to receive weekly SMS reminder (n = 123) or Standard Care (n = 121) between May 2015 and December 2018. The odds of adherence was higher at 6-month in SMS (OR = 1.78, 95% CI 1.04-3.05, p = 0.034), and not significantly different at 1-year (OR = 1.15, 95% CI: 0.67-1.96 p = 0.617). Mixed effects logistic regression analysis showed higher odds of adherence in SMS over the 1-year period (OR = 2.35, 95% CI: 1.01-5.49, p = 0.048). There was no difference in serum hormone levels between groups.
CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term. Future studies could investigate the use of tailored SMS intervention according to patient preference to improve its sustainability.",2020,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","['patients with breast cancer on aromatase inhibitors', 'patients', '244 patients', 'women with breast cancer']","['short message service (SMS) reminder', 'SMS', 'adjuvant aromatase inhibitor', 'SMS intervention', 'SMS reminder (n\xa0=\xa0123) or Standard Care']","['Medication adherence', 'Androstenedione, estradiol, and estrone', 'medication adherence and serum hormones', 'odds of adherence', 'serum hormones levels', 'androstenedione and estrone levels', 'serum hormone levels', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0236379', 'cui_str': 'Estrone measurement'}]",244.0,0.22356,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","[{'ForeName': 'Eng Hooi', 'Initials': 'EH', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore.'}, {'ForeName': 'Andrea Li Ann', 'Initials': 'ALA', 'LastName': 'Wong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Chuan Chien', 'Initials': 'CC', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, 1 Jurong East Street 21, 609606, Singapore.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology Pharmacy, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Sing Huang', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'OncoCare Cancer Centre, 6 Napier Road, #02-17/18/19, Gleneagles Medical Centr, 258499, Singapore.'}, {'ForeName': 'Li En Yvonne', 'Initials': 'LEY', 'LastName': 'Ang', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Siew Eng', 'Initials': 'SE', 'LastName': 'Lim', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Wan Qin', 'Initials': 'WQ', 'LastName': 'Chong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Jingshan', 'Initials': 'J', 'LastName': 'Ho', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Soo Chin', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore; Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, 1E Kent Ridge Road, 119228, Singapore. Electronic address: ephtbc@nus.edu.sg.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.012']
1405,32653532,Quantitative Assessment of the Efficacy of Two Different Single-file Systems in Reducing the Bacterial load in Oval-Shaped Canals: A Clinical Study.,"INTRODUCTION


This randomized clinical study compared the in vivo antibacterial efficacy of Reciproc Blue (RB), XP-endo Shaper (XP-S), and XP-endo Shaper associated with XP-endo Finisher (XP-F) systems in infected oval-shaped root canals with primary apical periodontitis.
METHODS


In this study, 28 human teeth with a single root and a single canal were randomly assigned to 2 groups according to the instrumentation technique: group 1, RB (n = 14) and group 2, XP-endo (XP-S and XP-F, n = 14). The single-rooted teeth were prepared by reciprocating and rotary nickel-titanium instruments with 5.25% sodium hypochlorite irrigation. Samples were collected from the canal at the baseline (S1), after chemomechanical preparation (S2), and after XP-F instrumentation (S3). The DNA extracts were subjected to quantitative analysis for total bacterial counts by quantitative real-time polymerase chain reaction. The data were analyzed using the analysis of variance test, and the level of significance was set at 5%.
RESULTS


All samples tested positive for the presence of bacteria at baseline, and the bacterial counts substantially reduced after treatment procedures (P < .01). The results showed no statistical difference between RB and XP-S instrumentation with respect to the bacterial reduction (P > .05). A marked bacterial reduction was observed after the use of the XP-F instrument (P < .01).
CONCLUSIONS


The XP-S and RB systems sharply reduced the bacterial load in oval-shaped root canals with primary apical periodontitis. XP-F used as a supplementary instrument to chemomechanical preparation promoted a significantly higher bacterial reduction.",2020,The results showed no statistical difference between RB and XP-S instrumentation with respect to the bacterial reduction (P ˃ 0.05).,"['Oval- Shaped Canals', '28 human teeth with a single root and a single canal', 'infected oval-shaped root canals with primary apical periodontitis']","['reciprocating and rotary nickel-titanium (NiTi) instruments with 5.25% sodium hypochlorite irrigation', 'Reciproc Blue (RB), XP-endo Shaper (XP-S),XP-endo Shaper associated with XP-endo Finisher (XP-F) systems']","['bacterial counts', 'bacterial reduction']","[{'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}]","[{'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",28.0,0.0301852,The results showed no statistical difference between RB and XP-S instrumentation with respect to the bacterial reduction (P ˃ 0.05).,"[{'ForeName': 'Rodrigo Rodrigues', 'Initials': 'RR', 'LastName': 'Amaral', 'Affiliation': 'School of Dentistry and Oral Health Griffith University, Gold Coast, Queensland, Australia; Department of Dentistry, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil. Electronic address: dr.rodrigoamaral@gmail.com.'}, {'ForeName': 'Anna Gabriella', 'Initials': 'AG', 'LastName': 'Guimarães Oliveira', 'Affiliation': 'Laboratory of Oral Microbiology and Anaerobes, Department of Microbiology, Institute of Biological Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Braga', 'Affiliation': 'School of Dentistry and Oral Health Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reher', 'Affiliation': 'School of Dentistry and Oral Health Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'de Macêdo Farias', 'Affiliation': 'Laboratory of Oral Microbiology and Anaerobes, Department of Microbiology, Institute of Biological Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Paula Prazeres', 'Initials': 'PP', 'LastName': 'Magalhães', 'Affiliation': 'Laboratory of Oral Microbiology and Anaerobes, Department of Microbiology, Institute of Biological Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Pedro Gonçalves', 'Initials': 'PG', 'LastName': 'Ferreira', 'Affiliation': 'Department of Dentistry, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ilma de Souza Côrtes', 'Affiliation': 'Department of Dentistry, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}]",Journal of endodontics,['10.1016/j.joen.2020.06.007']
1406,32590519,Efficiency in DIEP Flap Breast Reconstruction: The Real Benefit of Computed Tomographic Angiography Imaging.,"BACKGROUND


In deep inferior epigastric perforator (DIEP) flap breast reconstruction, many surgeons use preoperative imaging for perforator mapping as a method to plan the operation, reduce operative times, and potentially limit morbidity. This study compared operative times for specific portions of DIEP flap harvest with and without preoperative computed tomographic angiography imaging.
METHODS


Two patient groups undergoing DIEP flap breast reconstruction were studied prospectively. In the experimental group, the harvesting surgeon was blinded to the preoperative computed tomographic angiography scan; in the control group, the harvesting surgeon assessed the scan preoperatively. Times for initial perforator identification, perforator selection, flap harvest time, and total procedure times were compared. Perforator choice was evaluated. Correlation of perforator choice preoperatively and intraoperatively was also performed.
RESULTS


Times were recorded in 60 DIEP flaps (27 blinded and 33 unblinded). The nonblinded group was more efficient in all categories: time to first perforator identification (28.6 minutes versus 17.8 minutes; p < 0.0001), time to perforator decision-making (23.1 minutes versus 5.6 minutes; p < 0.0001), time to flap harvest (128 minutes versus 80 minutes; p < 0.0001), and total operative time (417 minutes versus 353 minutes; p < 0.001). Perforator location was not different between groups. Blinded intraoperative decisions correlated with preoperative imaging in 74 percent of flaps. More perforators were included in the blinded flaps compared to the nonblinded flaps (2.3 versus 1.4; p < 0.001).
CONCLUSIONS


Use of preoperative computed tomographic angiography leads to decreased operative times, specifically with regard to perforator identification and perforator selection. Without preoperative computed tomographic angiography, surgeons included more perforators in the flaps.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2020,"The non-blinded group was more efficient in all categories; time to first perforator identification (28.6 vs. 17.8 minutes, p<0.0001), time to perforator decision-making (23.1 vs. 5.6 minutes, p<0.0001), time to flap harvest (128 vs 80 min, p<0.0001), and total operative time (417 vs 353 min, p<0.001).","['DIEP Flap Breast Reconstruction', 'two patient groups undergoing']","['DIEP flap harvest with and without preoperative CTA imaging', 'DIEP flap breast reconstruction']","['initial perforator identification, perforator selection, flap harvest time, and total procedure times', 'total operative time', 'time to flap harvest', 'operative times', 'time to perforator decision-making']","[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0182209', 'cui_str': 'Perforator'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",,0.0361083,"The non-blinded group was more efficient in all categories; time to first perforator identification (28.6 vs. 17.8 minutes, p<0.0001), time to perforator decision-making (23.1 vs. 5.6 minutes, p<0.0001), time to flap harvest (128 vs 80 min, p<0.0001), and total operative time (417 vs 353 min, p<0.001).","[{'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Haddock', 'Affiliation': 'Dallas, Texas From the Department of Plastic Surgery, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Danielle O', 'Initials': 'DO', 'LastName': 'Dumestre', 'Affiliation': ''}, {'ForeName': 'Sumeet S', 'Initials': 'SS', 'LastName': 'Teotia', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007148']
1407,32590521,Effect of Cyclic Compressive Forces on New Bone Formation during the Distraction Period in Mandibular Distraction Osteogenesis Using a Microactuator-Generated Distractor.,"BACKGROUND


The traditional method of distraction required a long period until the new bone was fully fused. This study aimed to evaluate the effect of cyclic and repetitive compressive force on new bone formation by applying a newly designed microactuator-generated distractor compared with the traditional distraction protocol.
METHODS


The distraction devices were applied to the right and left mandibles of eight mature beagles, four of which were allocated to the experimental group and the other four to the control group. After a 5-day latency period, in the experimental group, 1.5-mm distraction and 0.5-mm compression were alternately applied every 12 hours; and in the control group, 0.5-mm distraction was repeated every 12 hours to perform a total of 7-mm mandibular lengthening. After an 8-week consolidation period, microstructure analysis using micro-computed tomography and histologic evaluations were performed.
RESULTS


Bone volume fraction and trabecular number were significantly higher in the experimental group. Trabecular thickness did not show a significant difference, and trabecular separation was significantly higher in the control group. The measurement of new bone was significantly higher in the experimental group, but the difference in mineral apposition rate between the experimental and control groups was not statistically significant.
CONCLUSIONS


This study has revealed that applying cyclic compressive and tensile forces during the distraction period induces better new bone formation than repetitive distraction alone. In addition, the new distraction device produced reliable distraction results during the experiment.",2020,"The measurement of new bone area showed significantly higher in the experimental group, but the difference in mineral apposition rate between the experimental and control groups was not statistically significant.
",[],"['cyclic compressive forces', 'cyclic and repetitive compressive force']","['mineral apposition rate', 'measurement of new bone area', 'new bone formation', 'Bone volume fraction and trabecular number', 'Trabecular thickness', 'And trabecular separation']",[],"[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]","[{'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0036679', 'cui_str': 'Separation'}]",,0.0166226,"The measurement of new bone area showed significantly higher in the experimental group, but the difference in mineral apposition rate between the experimental and control groups was not statistically significant.
","[{'ForeName': 'Hyun-Jin', 'Initials': 'HJ', 'LastName': 'Kwon', 'Affiliation': 'Seoul and Cheonan, Republic of Korea From the Division in Anatomy and Developmental Biology, Department of Oral Biology, Human Identification Research Institute, the Department of Orthodontics, Institute of Craniofacial Deformity, BK21 PLUS Project, and the Department of Oral and Maxillofacial Surgery, Yonsei University College of Dentistry; the Department of Anatomy, Yonsei University College of Medicine; and the Department of Oral Anatomy, Dankook University College of Dentistry.'}, {'ForeName': 'Jung-Yul', 'Initials': 'JY', 'LastName': 'Cha', 'Affiliation': ''}, {'ForeName': 'Jong-Tae', 'Initials': 'JT', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Hyung Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hee-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007152']
1408,32593895,Effect of administration of β-hydroxy-β-methyl butyrate-enriched formula after liver transplantation: A pilot randomized controlled trial.,"OBJECTIVE


Most patients undergoing liver transplantation (LT) have decreased skeletal muscle mass, malnutrition, and decreased physical activity levels. These comorbidities may prevent early recovery after surgery. The aim of this study was to examine the effects of oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite that promotes muscle synthesis and suppresses proteolysis, on postoperative sarcopenia and other outcomes after adult-to-adult living donor LT (LDLT).
METHODS


Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria were randomly assigned in a 1:1 ratio to the HMB or control group. Patients in the HMB group received two packs of HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine (7000 mg) per pack orally or enterally from postoperative day 1 to 30 with postoperative rehabilitation. The primary endpoint was grip strength (GS) at 2 mo after LDLT. Secondary endpoints included GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS).
RESULTS


Twelve patients in the HMB group and 11 in the control group were included in the final analysis. GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04). In the HMB group, white blood cell count 3 wk after LDLT was significantly lower (P = 0.005), and postoperative hospital LOS was significantly shorter (P = 0.028) compared with the control group. The incidence of postoperative bacteremia was lower in the HMB group.
CONCLUSIONS


Postoperative administration of HMB-enriched formula with rehabilitation significantly increased GS at 1 and 2 mo and SMI at 2 mo and shortened postoperative hospital LOS after LDLT.",2020,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","['patients undergoing liver transplantation (LT', 'after liver transplantation', 'adult-to-adult living donor LT (LDLT', 'Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria', 'Twelve patients in the HMB group and 11 in the control group were included in the final analysis']","['HMB', 'oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite', 'HMB or control group', 'HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine', 'β-hydroxy-β-methyl butyrate-enriched formula']","['SMI values', 'grip strength (GS', 'white blood cell count', 'incidence of postoperative bacteremia', 'postoperative hospital LOS', 'GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS', 'GS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",33.0,0.0731392,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kamo', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Kaido', 'Affiliation': ""Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Gastroenterological and General Surgery, St Luke's International University and Hospital, Tokyo, Japan. Electronic address: kaido@kuhp.kyoto-u.ac.jp.""}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Uozumi', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yagi', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Taura', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Uemoto', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110871']
1409,32606640,Critical Error Frequency and the Impact of Training with Inhalers Commonly used for Maintenance Treatment in Chronic Obstructive Pulmonary Disease.,"Introduction


Training in correct inhaler use, ideally in person or by video demonstration, can minimize errors but is rarely provided in clinics. This open-label, low-intervention study evaluated critical error rates with dry-powder inhalers (DPIs), before and after training, in patients with chronic obstructive pulmonary disease.
Methods


Patients prescribed an inhaled corticosteroid (ICS)/long-acting β 2 -agonist (LABA) (ELLIPTA, Turbuhaler, or DISKUS), long-acting muscarinic antagonist (LAMA)/LABA (ELLIPTA or Breezhaler), or LAMA-only DPI (ELLIPTA, HandiHaler, or Breezhaler) were enrolled. Critical errors were assessed before training (Visit 1 [V1]; primary endpoint) and 6 weeks thereafter (Visit 2 [V2]; secondary endpoint). Logistic regression models were used to calculate odds ratios (ORs) for between-group comparisons.
Results


The intent-to-treat population comprised 450 patients. At V1, fewer patients made ≥1 critical error with ELLIPTA (10%) versus other ICS/LABA DPIs (Turbuhaler: 40%, OR 4.66,  P =0.005; DISKUS: 26%, OR 2.48,  P =0.114) and other LAMA or LAMA/LABA DPIs (HandiHaler: 34%, OR 3.50,  P =0.026; Breezhaler: 33%, OR 3.94,  P =0.012). Critical error rates with the primary ICS/LABA DPI were not significantly different between ELLIPTA ICS/LABA (10%) and ICS/LABA plus LAMA groups (12-25%). Critical errors with the primary ICS/LABA DPI occurred less frequently with ELLIPTA ICS/LABA with or without LAMA (11%) versus Turbuhaler ICS/LABA with or without LAMA (39%, OR 3.99,  P <0.001) and DISKUS ICS/LABA with or without LAMA (26%, OR 2.18,  P =0.069). Simulating single-inhaler versus multiple-inhaler triple therapy, critical error rates were lower with ELLIPTA fluticasone furoate/vilanterol (FF/VI; 10%) versus ELLIPTA FF/VI plus LAMA (22%), considering errors with either DPI (OR 2.50,  P =0.108). At V2, critical error rates decreased for all DPIs/groups, reaching zero only for ELLIPTA. Between-group comparisons were similar to V1.
Conclusion


Fewer patients made critical errors with ELLIPTA versus other ICS/LABA, and LAMA or LAMA/LABA DPIs. The effect of ""verbal"" training highlights its importance for reducing critical errors with common DPIs.",2020,"LABA with or without LAMA (26%, OR 2.18,  P =0.069).","['patients with chronic obstructive pulmonary disease', 'Chronic Obstructive Pulmonary Disease']","['ELLIPTA ICS/LABA', 'Training with Inhalers', 'primary ICS', 'inhaled corticosteroid', 'ELLIPTA fluticasone furoate/vilanterol', 'verbal"" training', 'ELLIPTA ICS', 'ICS)/long-acting β 2 -agonist (LABA) (ELLIPTA, Turbuhaler, or DISKUS), long-acting muscarinic antagonist (LAMA)/LABA (ELLIPTA or Breezhaler), or LAMA-only DPI (ELLIPTA, HandiHaler, or Breezhaler', 'dry-powder inhalers (DPIs', 'ELLIPTA FF/VI plus LAMA', 'ELLIPTA', 'LABA with or without LAMA']","['critical error rates', 'LABA DPI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C1967611', 'cui_str': 'Dry powder inhaler'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],,0.0749442,"LABA with or without LAMA (26%, OR 2.18,  P =0.069).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Collier', 'Affiliation': 'William Harvey Research Institute, Barts & The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Wielders', 'Affiliation': 'Department of Pulmonary Diseases, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Logan', 'Initials': 'L', 'LastName': 'Heyes', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline Plc., Stockley Park, Uxbridge, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Midwinter', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline Plc., Stockley Park, Uxbridge, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Collison', 'Affiliation': 'Respiratory Medical Franchise, GlaxoSmithKline Plc., Research Triangle Park, Durham, NC, USA.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Preece', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline Plc., Stockley Park, Uxbridge, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Barnes', 'Affiliation': 'William Harvey Research Institute, Barts & The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline Plc., Stockley Park, Uxbridge, UK.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S224209']
1410,32613332,Matching Psychosocial Support Needs of Parents of a Child with a Chronic Illness to a Feasible Intervention.,"OBJECTIVES


Parents of children with a chronic illness (CI) are at risk for psychosocial problems. The aim of this study was to refine an existing face-to-face intervention into an online psychosocial group intervention for parents by (1) exploring which themes are important, (2) determine what type of intervention parents would like and (3) assess parents' practical preferences.
METHODS


Parents of children with a CI (0-18 years) were invited to complete an online questionnaire. To acquire more in-depth information, focus groups and telephone interviews were conducted. Descriptive statistics were used.
RESULTS


272 parents (mean age = 43.1 years, 85% female) participated. Three focus groups (15 parents) and seven telephone interviews were conducted. Most important themes were: the CI of the child, family functioning, taking care of yourself, relationships with others and practical support. Parents preferred a group with parents of children in the same age category. At first, parents preferred face-to-face contact. After an explanation and demonstration of an online intervention, parents became more positive about online support, mostly because they could participate from home.
CONCLUSIONS FOR PRACTICE


Parents have a need for psychosocial support focusing on different themes. Professionals should explain and demonstrate an online intervention to parents. Based on these results, Op Koers Online for parents was developed. An RCT to assess feasibility and effectiveness of the intervention is currently running.",2020,"After an explanation and demonstration of an online intervention, parents became more positive about online support, mostly because they could participate from home.
","['Parents of children with a chronic illness (CI', 'Parents of children with a CI (0-18\xa0years', '272 parents (mean age\u2009=\u200943.1\xa0years, 85% female) participated']",[],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],272.0,0.0280083,"After an explanation and demonstration of an online intervention, parents became more positive about online support, mostly because they could participate from home.
","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Douma', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. m.douma@amsterdamumc.nl.""}, {'ForeName': 'Charlotte P', 'Initials': 'CP', 'LastName': 'Bouman', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Hedy A', 'Initials': 'HA', 'LastName': 'van Oers', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Maurice-Stam', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Haverman', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Grootenhuis', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Linde', 'Initials': 'L', 'LastName': 'Scholten', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}]",Maternal and child health journal,['10.1007/s10995-020-02925-3']
1411,32615473,Acceptance and commitment therapy combined with vestibular rehabilitation for persistent postural-perceptual dizziness: A pilot study.,"PURPOSE


This study investigated the feasibility of acceptance and commitment therapy for persistent postural-perceptual dizziness and preliminarily verified the long-term effectiveness of the therapy.
MATERIALS AND METHODS


This study implemented the within-group pre-post comparison design. We enrolled 27 adult patients who met the criteria of persistent postural-perceptual dizziness. They underwent a treatment program including acceptance and commitment therapy combined with vestibular rehabilitation once a week for a total of six sessions. The primary outcome was changes in the Dizziness Handicap Inventory score 6 months posttreatment.
RESULTS


All 27 patients completed the acceptance and commitment therapy + vestibular rehabilitation program, and 25 patients (92.6%) could be followed for 6 months posttreatment. For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42). At 6 months posttreatment, 11 patients (40.7%) achieved remission (the score ≤ 14), 16 (59.3%) achieved treatment response (reduction in the score ≥ 18), and 20 (74.1%) achieved remission and/or treatment response.
CONCLUSIONS


Acceptance and commitment therapy is feasible for persistent postural-perceptual dizziness and might have long-term effectiveness. However, a randomized controlled trial is warranted.",2020,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","['persistent postural-perceptual dizziness', '27 adult patients who met the criteria of persistent postural-perceptual dizziness']","['Acceptance and commitment therapy combined with vestibular rehabilitation', 'acceptance and commitment therapy', 'acceptance and commitment therapy combined with vestibular rehabilitation']","['Dizziness Handicap Inventory effect size', 'remission', 'Dizziness Handicap Inventory score 6\xa0months posttreatment', 'remission and/or treatment response']","[{'cui': 'C0522360', 'cui_str': 'Persistent postural perceptual dizziness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",27.0,0.176719,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: jurry7777@hotmail.co.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kondo-masaki@umin.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kabaya', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kabaya@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Watanabe', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Kikuchi Mental Clinic, Ushikubo-cho, Toyokawa 442-0826, Japan. Electronic address: wakakoigarashi@gmail.com.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: fecitanno@gmail.com.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Sakai', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: mie.sakai.38@gmail.com.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Toshishige', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: yuu0323uchi@yahoo.co.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ino', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: miniture_flute@hotmail.com.'}, {'ForeName': 'Meiho', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Good Sleep Center, Nagoya City University Hospital, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: nakayama@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: iwashin-tky@umin.ac.jp.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102609']
1412,32618656,Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial.,"INTRODUCTION


Nonalcoholic fatty liver disease (NAFLD) is an obesity-related disorder that is rapidly increasing in incidence and is considered the hepatic manifestation of the metabolic syndrome. The gut microbiome plays a role in metabolism and maintaining gut barrier integrity. Studies have found differences in the microbiota between NAFLD and healthy patients and increased intestinal permeability in patients with NAFLD. Fecal microbiota transplantation (FMT) can be used to alter the gut microbiome. It was hypothesized that an FMT from a thin and healthy donor given to patients with NAFLD would improve insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability.
METHODS


Twenty-one patients with NAFLD were recruited and randomized in a ratio of 3:1 to either an allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum. IR was calculated by HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability was tested using the lactulose:mannitol urine test. Additional markers of metabolic syndrome and the gut microbiota were examined. Patient visits occurred at baseline, 2, 6 weeks, and 6 months post-FMT.
RESULTS


There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT. Allogenic FMT patients with elevated small intestinal permeability (>0.025 lactulose:mannitol, n = 7) at baseline had a significant reduction 6 weeks after allogenic FMT.
DISCUSSION


FMT did not improve IR as measured by HOMA-IR or hepatic PDFF but did have the potential to reduce small intestinal permeability in patients with NAFLD.",2020,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"['Patients With Nonalcoholic Fatty Liver Disease Improves', 'patients with NAFLD', 'Twenty-one patients with NAFLD', 'Abnormal Small Intestinal Permeability']","['Allogenic Fecal Microbiota Transplantation', 'Fecal microbiota transplantation (FMT', 'allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum', 'FMT', 'allogenic or autologous FMT', 'Allogenic FMT']","['HOMA-IR or hepatic PDFF', 'Patient visits', 'intestinal permeability', 'insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability', 'small intestinal permeability', 'HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",21.0,0.0335215,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Craven', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nair Parvathy', 'Affiliation': ""Division of Infectious Disease, St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Beaton', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Program in Computational Biology and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Qumosani', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hegele', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Joy', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Urquhart', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'The Canadian Centre for Microbiome and Probiotic Research, London, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Burton', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000661']
1413,32619792,Human urine  1 H NMR metabolomics reveals alterations of the protein and carbohydrate metabolism when comparing habitual Average Danish diet vs. healthy New Nordic diet.,"OBJECTIVES


The aim of this study was to investigate the alteration of the human urine metabolome by means of diet and to compare the metabolic effects of the nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD). The NND was designed a decade ago by scientists and chefs, based on local and sustainable foods, including fish, shellfish, vegetables, roots, fruit, and berries. The NND has been proven to lower blood pressure, reduce glycemia, and lead to weight loss.
METHODS


The human urine metabolome was measured by untargeted proton nuclear magnetic resonance spectroscopy in samples from 142 centrally obese Danes (20-66 years old), randomized to consume the ADD or the NND. The resulting metabolomics data was processed and analyzed using advanced multivariate data analysis methods to reveal effects related to the design factors, including diet, season, sex, and changes in body weight.
RESULTS


Exploration of the nuclear magnetic resonance profiles revealed unique metabolite markers reflecting changes in protein and carbohydrate metabolism between the two diets. Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased. Propylene glycol had a strong association with the homeostatic model assessment for insulin resistance in the NND group. The food intake biomarkers found in this study confirm the importance of these as tools for nutritional research.
CONCLUSIONS


Findings from this study provided new insights into the effects of a healthy diet on glycemia, reduction of inflammation, and weight loss among obese individuals, and alteration of the gut microbiota metabolism.",2020,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.",['in samples from 142 centrally obese Danes (20-66 years old'],"['nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD', 'Propylene glycol', 'untargeted proton nuclear magnetic resonance spectroscopy']","['relative concentrations of tartrate, dimethyl sulfone, and propylene glycol', 'glycemia, reduction of inflammation, and weight loss', 'Glycine betaine, glucose, trimethylamine N-oxide and creatinine']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0337800', 'cui_str': 'Danes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0877853', 'cui_str': 'Spectroscopy, NMR'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039328', 'cui_str': 'Tartrates'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",142.0,0.027383,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Trimigno', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bekzod', 'Initials': 'B', 'LastName': 'Khakimov', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Savorani', 'Affiliation': 'Department of Applied Science and Technology, Polytechnic of Turin, Turin, Italy.'}, {'ForeName': 'Sanne Kellebjerg', 'Initials': 'SK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren Balling', 'Initials': 'SB', 'LastName': 'Engelsen', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. Electronic address: se@food.ku.dk.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110867']
1414,32621900,Comparison of Toric Implantable Collamer Lens and Toric Artiflex Phakic IOLs in Terms of Visual Outcome: a Paired Contralateral Eye Study.,"PURPOSE


This study sought to compare the postoperative visual outcomes of toric implantable collamer lens (T-ICL) with toric Artiflex (T-Artiflex) lenses.
DESIGN


Alternating treatment, contralateral eye matched clinical study.
METHODS


This study compared 82 eyes of 41 patients with T-ICL lenses in one eye and toric Artiflex implantation in the contralateral eye to correct myopic astigmatism. Safety, efficacy, predictability, astigmatic vector changes, contrast sensitivity, endothelial cell count, and possible adverse events were assessed at least 12 months postoperatively.
RESULTS


After a mean follow-up of 12 months, the safety index was mean 1.40 ± 0.70 in the T-ICL group and 1.20 ± 0.21 in the T-Artiflex group. Furthermore, their mean efficacy indexes were 1.24 ± 0.42 and 1.08 ± 0.23, respectively (P = .029). A total of 39 eyes (95%) in the T-ICL group and 41 eyes (100%) in the T-Artiflex group were within ±1.00 diopter (D) of emmetropia and 33 eyes (80%) and 34 eyes (83%) were within ±0.5 D of emmetropia, respectively. Vector analysis revealed mean index of success as large as 0.25 ± 0.22 in the T-ICL group and 0.24 ± 0.15 in the T-Artiflex group. Postoperative contrast sensitivities were equal in both groups under mesopic conditions for any given spatial frequency. There was an endothelial loss of 2.18% and 1.95% in the T-ICL and T-Artiflex groups, respectively. There were no significant complications in any of the groups.
CONCLUSIONS


Both lenses showed promising results in terms of safety, efficacy, and predictability for correction of myopic astigmatism. As shown in this paired-eye study, most outcomes were almost identical, and neither of these lenses were clinically superior to the other.",2020,"There was no significant complication in any of the groups.
",['82 eyes of 41 patients with toric ICL implantation in one eye and toric Artiflex implantation in the contralateral eye to correct myopic astigmatism'],"['Toric Implantable Collamer Lens and Toric Artiflex Phakic IOLs', 'toric implantable collamer lens (T-ICL) and toric Artiflex (T-Artiflex) implantation']","['mean efficacy index', 'safety index', 'endothelial cell loss', 'Safety, efficacy, predictability, astigmatic vector changes, contrast sensitivity, endothelial cell count, and possible adverse events', 'mean index of success', 'safety, efficacy, and predictability']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C2363771', 'cui_str': 'Myopic astigmatism'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",41.0,0.0443315,"There was no significant complication in any of the groups.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghoreishi', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran; Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Kashfi', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran. Electronic address: drkashfi@gmail.com.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Peyman', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran.'}, {'ForeName': 'Mohadeseh', 'Initials': 'M', 'LastName': 'Mohammadinia', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.021']
1415,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous flap.","OBJECTIVES


Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS


Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS


The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION


The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Han Jiang', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
1416,32639465,Daptomycin for Pediatric Gram-Positive Acute Hematogenous Osteomyelitis.,"BACKGROUND


We prospectively evaluated efficacy and safety of daptomycin versus active comparator in children with acute hematogenous osteomyelitis (AHO).
METHODS


Randomized, controlled, double-blind, global, multicenter, phase 3 trial. Patients 1-17 years of age with suspected/confirmed AHO requiring hospitalization and intravenous therapy were randomized 1:1 to intravenous daptomycin (once-daily, age-adjusted doses) or comparator (vancomycin, nafcillin or equivalent) ≥4 days, followed by oral therapy (14-42 days total). Primary endpoint: protocol-defined clinical improvement by Day 5 in the modified intention-to-treat (MITT) population (confirmed AHO, ≥1 dose of study treatment); differences between study arms were evaluated using a prespecified 15% noninferiority margin for daptomycin.
RESULTS


Seventy-three patients per arm received treatment. Pathogens were isolated from 62% of patients (83% methicillin-susceptible Staphylococcus aureus, 9% methicillin-resistant S. aureus [MRSA]). Clinical improvement by Day 5 was observed in 55/71 (78%) daptomycin- and 58/70 (83%) comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4). This difference was not statistically significant; however, daptomycin did not meet the prespecified 15% noninferiority margin, since the lower bound of the 95% CI extended below 15%. Overall, 82% of daptomycin and 87% of comparator patients achieved clinical cure at the test-of-cure visit (secondary endpoint). More comparator patients had treatment-emergent (63% vs. 46%) and treatment-related (18% vs. 7%) adverse events.
CONCLUSIONS


Differences between daptomycin and comparator for the primary endpoint were not statistically significant; however, prespecified noninferiority criteria for daptomycin were not met. With insufficient cases of confirmed MRSA, we could not evaluate daptomycin for MRSA AHO. Our nonvalidated protocol design yields valuable information for implementing future trials in AHO (ClinicalTrials.gov NCT01922011).",2020,"comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4).","['Patients 1-17 years of age with suspected/confirmed AHO requiring hospitalization and intravenous therapy', 'children with acute hematogenous osteomyelitis (AHO']","['daptomycin', 'comparator (vancomycin, nafcillin or equivalent) ≥4 days, followed by oral therapy', 'intravenous daptomycin', 'Daptomycin']","['clinical cure', 'protocol-defined clinical improvement by Day 5 in the modified intention-to-treat (MITT) population (confirmed AHO, ≥1 dose of study treatment); differences', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0600123', 'cui_str': 'Acute hematogenous osteomyelitis'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0027324', 'cui_str': 'Nafcillin'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0600123', 'cui_str': 'Acute hematogenous osteomyelitis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.601159,"comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4).","[{'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Bradley', 'Affiliation': ""From the Division of Infectious Diseases, Rady Children's Hospital San Diego, San Diego, CA.""}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Orange, CA.""}, {'ForeName': 'Valeri A', 'Initials': 'VA', 'LastName': 'Digtyar', 'Affiliation': ""Dnipropetrovsk Regional Children's Clinical Hospital, Dnipropetrovsk, Ukraine.""}, {'ForeName': 'Myra W', 'Initials': 'MW', 'LastName': 'Popejoy', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Grandhi', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bokesch', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Hershberger', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Tan', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Murata', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Dominik J', 'Initials': 'DJ', 'LastName': 'Wolf', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Mekki', 'Initials': 'M', 'LastName': 'Bensaci', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002790']
1417,32643163,Effects of a standardized community health worker intervention on hospitalization among disadvantaged patients with multiple chronic conditions: A pooled analysis of three clinical trials.,"OBJECTIVE


To analyze the effects of a standardized community health worker (CHW) intervention on hospitalization.
DATA SOURCES/STUDY SETTING


Pooled data from three randomized clinical trials (n = 1340) conducted between 2011 and 2016.
STUDY DESIGN


The trials in this pooled analysis were conducted across diseases and settings, with a common study design, intervention, and outcome measures. Participants were patients living in high-poverty regions of Philadelphia and were predominantly Medicaid insured. They were randomly assigned to receive usual care versus IMPaCT, an intervention in which CHWs provide tailored social support, health behavior coaching, connection with resources, and health system navigation. Trial one (n = 446) tested two weeks of IMPaCT among hospitalized general medical patients. Trial two (n = 302) tested six months of IMPaCT among outpatients at two academic primary care clinics. Trial three (n = 592) tested six months of IMPaCT among outpatients at academic, Veterans Affairs (VA), and Federally Qualified Health Center primary care practices.
DATA COLLECTION/EXTRACTION METHODS


The primary outcome for this study was all-cause hospitalization, as measured by total number of hospital days per patient. Hospitalization data were collected from statewide or VA databases at 30 days postenrollment in Trial 1, twelve months postenrollment in Trial 2, and nine months postenrollment in Trial 3.
PRINCIPAL FINDINGS


Over 9398 observed patient months, the total number of hospital days per patient in the intervention group was 66 percent of the total in the control group (849 days for 674 intervention patients vs 1258 days for 660 control patients, incidence rate ratio (IRR) 0.66, P < .0001). This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03). The intervention also decreased rates of hospitalization outside patients' primary health system (18.8 percent vs 34.8 percent, P = .0023).
CONCLUSIONS


Data from three randomized clinical trials across multiple settings show that a standardized CHW intervention reduced total hospital days and hospitalizations outside the primary health system. This is the largest analysis of randomized trials to demonstrate reductions in hospitalization with a health system-based social intervention.",2020,"This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03).","['Participants were patients living in high-poverty regions of Philadelphia and were predominantly Medicaid insured', 'outpatients at two academic primary care clinics', 'hospitalized general medical patients', 'outpatients at academic, Veterans Affairs (VA), and Federally Qualified Health Center primary care practices', 'Pooled data from three randomized clinical trials (n\xa0', 'disadvantaged patients with multiple chronic conditions', '1340) conducted between 2011 and 2016']","['standardized community health worker intervention', 'standardized CHW intervention', 'usual care versus IMPaCT, an intervention in which CHWs provide tailored social support, health behavior coaching, connection with resources, and health system navigation', 'standardized community health worker (CHW) intervention']","['incidence rate ratio', 'total hospital days and hospitalizations', ""rates of hospitalization outside patients' primary health system"", 'total number of hospital days per patient', 'shorter mean length of stay', 'cause hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.281442,"This reduction was driven by fewer hospitalizations per patient (0.27 vs 0.34, P < .0001) and shorter mean length of stay (4.72 vs 5.57 days, P = .03).","[{'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Vasan', 'Affiliation': 'National Clinician Scholars Program, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Morgan', 'Affiliation': 'National Clinician Scholars Program, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Mitra', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Kangovi', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Health services research,['10.1111/1475-6773.13321']
1418,32647935,Correction to: Efficacy of pulsed Nd:YAG laser in the treatment of patients with knee osteoarthritis: a randomized controlled trial.,The institutional affiliation of Dr. Aly Elsayed Mohamed Elsayed should be as follow.,2020,The institutional affiliation of Dr. Aly Elsayed Mohamed Elsayed should be as follow.,['patients with knee osteoarthritis'],['pulsed Nd:YAG laser'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}]",[],,0.0401531,The institutional affiliation of Dr. Aly Elsayed Mohamed Elsayed should be as follow.,"[{'ForeName': 'Mohamed Salaheldien Mohamed', 'Initials': 'MSM', 'LastName': 'Alayat', 'Affiliation': 'Department of Physical Therapy, Faculty of Applied Medical Sciences, Umm Al-Qura University, Mecca, Saudi Arabia. mohsalahpt@hotmail.com.'}, {'ForeName': 'Tarek Helmy Ahmed', 'Initials': 'THA', 'LastName': 'Aly', 'Affiliation': 'Radiology Department, Um Al-Qura University Medical Center, Mecca, Saudi Arabia.'}, {'ForeName': 'Aly Elsayed Mohamed', 'Initials': 'AEM', 'LastName': 'Elsayed', 'Affiliation': 'Al-Noor Specialist Hospital, Mecca, Saudi Arabia.'}, {'ForeName': 'Ammar Suliman Mohamed', 'Initials': 'ASM', 'LastName': 'Fadil', 'Affiliation': 'Department of Physical Therapy, Faculty of Applied Medical Sciences, Umm Al-Qura University, Mecca, Saudi Arabia.'}]",Lasers in medical science,['10.1007/s10103-020-03088-x']
1419,32651141,"Effects of Zataria oxymel on obesity, insulin resistance and lipid profile: A randomized, controlled, triple-blind trial.","BACKGROUND


Obesity is a major public health problem and its occurrence is markedly increasing in developed and developing countries. However, few studies have investigated the use of natural products to treat obesity. The effects of taking a combination of oxymel and Zataria multiflora Boiss. (ZM), herein referred to as Zataria oxymel (ZO), on obesity, lipid profile and insulin resistance have not yet been studied.
OBJECTIVE


This study evaluates the effects of oxymel and ZO on obesity, lipid profile and insulin resistance.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS


In this randomized, controlled, triple-blind trial, overweight patients were randomly divided into three groups and received doses of study compounds twice per day for twelve weeks. Group A received 0.75 g ZM in 10 mL oxymel in each treatment; group B received 1.5 g ZM in 10 mL of oxymel in each treatment and group C (control) only received 10 mL of oxymel in each treatment.
MAIN OUTCOME MEASURES


Anthropometric parameters, including body mass index (BMI), waist circumference and hip circumference, were measured at the time of registration. Blood tests were carried out at the beginning and once again at end of the study. Blood parameters included fasting blood sugar (FBS), insulin levels, serum lipid profile (total cholesterol, triglyceride, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol) and liver enzymes (aspartate transaminase and alanine transaminase). Serum creatinine was also measured at the beginning of the project and in monthly intervals for three months. The homeostasis model assessment index was calculated as fasting insulin (μIU/mL) × FBS (mg/dL)/405.
RESULTS


The results showed that patients receiving ZO experienced significant reduction in waist circumference in groups A, B and C, respectively (P < 0.001) but no significant change in BMI. Group A also experienced reduction in hip circumference (P = 0.01). Groups B and C had reduction in the homeostatic model assessment of insulin resistance (P = 0.05 and P = 0.01, respectively), with no significant reduction in FBS. No effect on lipid profile, liver enzymes or serum creatinine was observed in the three groups.
CONCLUSION


In this study, treatment with ZO and oxymel reduced insulin resistance, and waist and hip circumferences in overweight patients. Nonetheless, the traditional Persian use of ZO as a beverage to improve the anthropometric indices in overweight individuals still requires further research with a larger sample size.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials Code IRCT20171220037976N1.",2020,"Groups B and C had reduction in the homeostatic model assessment of insulin resistance (P = 0.05 and P = 0.01, respectively), with no significant reduction in FBS.",['overweight patients'],"['ZM', 'ZM in 10\xa0mL of oxymel in each treatment and group C (control) only received 10\xa0mL of oxymel in each treatment', 'Zataria oxymel', 'oxymel and ZO']","['homeostasis model assessment index', 'Anthropometric parameters, including body mass index (BMI), waist circumference and hip circumference', 'waist circumference', 'hip circumference', 'homeostatic model assessment of insulin resistance', 'insulin resistance, and waist and hip circumferences', 'lipid profile, liver enzymes or serum creatinine', 'Serum creatinine', 'BMI', 'obesity, insulin resistance and lipid profile', 'FBS', 'fasting blood sugar (FBS), insulin levels, serum lipid profile (total cholesterol, triglyceride, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol) and liver enzymes (aspartate transaminase and alanine transaminase', 'obesity, lipid profile and insulin resistance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",,0.0641254,"Groups B and C had reduction in the homeostatic model assessment of insulin resistance (P = 0.05 and P = 0.01, respectively), with no significant reduction in FBS.","[{'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Abolghasemi', 'Affiliation': 'Research Center for Persian Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Farboodniay Jahromi', 'Affiliation': 'Medicinal Plants Processing Research Center, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hossein Sharifi', 'Affiliation': 'Research Center for Persian Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Mazloom', 'Affiliation': 'Department of Nutrition, School of Health and Nutrition, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Hosseini', 'Affiliation': 'Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Nasrindokht', 'Initials': 'N', 'LastName': 'Zamani', 'Affiliation': 'Research Center for Persian Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Nimrouzi', 'Affiliation': 'Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz 7134845794, Iran. Electronic address: mnimruzi@yahoo.com.'}]",Journal of integrative medicine,['10.1016/j.joim.2020.06.003']
1420,32659874,Impact of Comorbid PTSD on Outcome of Repetitive Transcranial Magnetic Stimulation (TMS) for Veterans With Depression.,"OBJECTIVE


A recent randomized controlled trial of repetitive transcranial magnetic stimulation (TMS) for major depressive disorder (MDD) in veterans raised the question of whether comorbid posttraumatic stress disorder (PTSD) negatively impacted the outcome of TMS in veterans. To address this, a quality database was analyzed to compare outcomes of MDD treated with TMS in veterans with and without comorbid PTSD.
METHODS


The clinical outcomes of all consecutive veterans with MDD treated with TMS at the James A. Haley Veterans' Hospital as outpatients from October 2013 through September 2018 were included. Patients were initially evaluated by an experienced psychiatrist, and the diagnosis of MDD was made by clinical evaluation per DSM-IV-TR/DSM-5 criteria. At the start of treatment, after every 5 treatments, and at the end of treatment, patients were assessed with self-report and clinician-rated scales of depression. All data were abstracted from an existing quality database.
RESULTS


Among the 118 patients treated with TMS for depression, 55 (47%) had comorbid PTSD and 63 (53%) had no comorbid PTSD. Response and remission rates by score on the Montgomery-Asberg Depression Rating Scale were similar between patients with PTSD (52.5% and 40.9%, respectively) and without PTSD (53.8% and 35.6%, respectively). No seizures or persistent adverse effects were observed or reported in either group.
CONCLUSIONS


Comorbid PTSD did not impact the outcome of TMS for depression in this sample of veterans. Future studies should include formal ratings of PTSD to determine if the severity of PTSD affects the outcome.",2020,"Response and remission rates by score on the Montgomery-Asberg Depression Rating Scale were similar between patients with PTSD (52.5% and 40.9%, respectively) and without PTSD (53.8% and 35.6%, respectively).","['Veterans With Depression', 'veterans with and without comorbid PTSD', '118 patients treated with TMS for depression, 55 (47%) had comorbid PTSD and 63 (53%) had no comorbid PTSD', ""consecutive veterans with MDD treated with TMS at the James A. Haley Veterans' Hospital as outpatients from October 2013 through September 2018 were included""]","['Repetitive Transcranial Magnetic Stimulation (TMS', 'TMS', 'repetitive transcranial magnetic stimulation (TMS']","['Montgomery-Asberg Depression Rating Scale', 'Response and remission rates', 'No seizures or persistent adverse effects']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0020030', 'cui_str': 'Veterans Hospitals'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0167948,"Response and remission rates by score on the Montgomery-Asberg Depression Rating Scale were similar between patients with PTSD (52.5% and 40.9%, respectively) and without PTSD (53.8% and 35.6%, respectively).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hernandez', 'Affiliation': ""James A. Haley Veterans' Hospital, Mental Health & Behavioral Sciences (116A), 13000 Bruce B. Downs Blvd, Tampa, FL 33612. mjhernandez@usf.edu.""}, {'ForeName': 'Tea', 'Initials': 'T', 'LastName': 'Reljic', 'Affiliation': 'Research Methodology and Biostatistics Core, Morsani College of Medicine, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Van Trees', 'Affiliation': ""Nursing Service, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Phillips', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Jaffrey', 'Initials': 'J', 'LastName': 'Hashimie', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bajor', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yehl', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'McKenzie', 'Affiliation': ""Research Service, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Burke', 'Affiliation': ""Nursing Service, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Sullivan', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Ambuj', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Research Methodology and Biostatistics Core, Morsani College of Medicine, University of South Florida, Tampa, Florida, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Sanchez', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Catalano', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}, {'ForeName': 'F Andrew', 'Initials': 'FA', 'LastName': 'Kozel', 'Affiliation': ""Mental Health and Behavioral Sciences, James A. Haley Veterans' Administration Hospital and Clinics, Tampa, Florida, USA.""}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13152']
1421,32664361,"Impact of Whole Body Electromyostimulation on Velocity, Power and Body Composition in Postmenopausal Women: A Randomized Controlled Trial.","Menopause is associated with losses in strength and power along with weight and fat mass gains, which may result from menopause-related hormonal changes, aging-associated diseases, and decreased physical activity time. The objective of this study is to analyze if whole-body electromyostimulation (WB-EMS) is suitable for the prevention and treatment of postmenopausal physical deterioration. Thirty-four healthy sedentary women between 55 and 69 years followed an experimental design pre-post test. Both groups conducted 10 weeks of aerobic and strength training program. The experimental group conducted the training with superimposed WB-EMS during exercise. At the end of the intervention, the experimental group obtained better power (Squat: mean difference (MD) = 38.69 W [1.75,75.62],  d  = 0.81; Bench press: MD = 25.64 W [17.48, 33.82],  d  = 2.39) and velocity (Squat: MD = 0.04 m·s -1  [0.01, 0.08],  d  = 0.98; Bench press: MD = 0.10 m·s -1  [0.06, 0.14],  d  = 1.90) score improvements than the other group ( p Bonferroni  < 0.05). Furthermore, trivial to small effects were found in the body composition of the participants of both groups ( p >  0.050). WB-EMS showed a favorable isolated effect on the development of power and velocity, but it induced negligible effects on the body composition of postmenopausal women.",2020,score improvements than the other group ( p Bonferroni  < 0.05).,"['Postmenopausal Women', 'postmenopausal women', 'Thirty-four healthy sedentary women between 55 and 69 years followed an experimental design pre-post test']","['whole-body electromyostimulation (WB-EMS', 'Whole Body Electromyostimulation', 'training with superimposed WB-EMS during exercise', 'aerobic and strength training program']","['body composition', 'Velocity, Power and Body Composition', 'score improvements', 'physical activity time']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0032919', 'cui_str': 'Pre-Post Tests'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",34.0,0.0381312,score improvements than the other group ( p Bonferroni  < 0.05).,"[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pano-Rodriguez', 'Affiliation': 'Research Group Human Movement, University of Lleida, E-25001 Lleida, Spain.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'Beltran-Garrido', 'Affiliation': 'EUSES Health and Sport Sciences School, Rovira i Virgili University, 43870 Tarragona, Spain.'}, {'ForeName': 'Vicenç', 'Initials': 'V', 'LastName': 'Hernandez-Gonzalez', 'Affiliation': 'Nutritional Coaching SL, 08011 Barcelona, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Nasarre-Nacenta', 'Affiliation': 'Nutritional Coaching SL, 08011 Barcelona, Spain.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Reverter-Masia', 'Affiliation': 'EUSES Health and Sport Sciences School, Rovira i Virgili University, 43870 Tarragona, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17144982']
1422,32664643,Effects of 6 Weeks Direct Instruction and Teaching Games for Understanding Programs on Physical Activity and Tactical Behaviour in U-12 Soccer Players.,"The purpose of this study was to compare the effects of 6 weeks direct instruction and teaching games for understanding (TGfU) programs on the decision-making and execution (post-interventions), as well, as on the physical activity (PA) levels during sessions. Thirty under-12 football players participated in this study (age: 10.3 ± 0.45 years) and were randomly assigned to TGfU ( n  = 15) or direct instruction ( n  = 15) group. Two sessions/week were implemented. Results revealed that TGfU promoted higher levels ( p  = 0.043; d = 2.99) of light PA (28.96%) compared with direct instruction (27.55%). Non-significant higher sedentary PA levels ( p  = 0.073; d = 2.62) were found in the control group (35.48%). In terms of tactical principles, conservation of the ball increased the percentage of moderate to vigorous physical activity in TGfU (43.60%) compared with direct instruction (38.05%). According to the Game Performance Evaluation Tool (GPET), significant improvements ( p  = 0.018, d = 3.78) of the attacking player with the ball in the percentage of change between groups in the unsuccessful execution in TGfU (% = -62.2) were observed compared with direct instruction (% = 14.2). TGfU seems to be more appropriate than direct instruction to increase the light PA levels during sessions while no significant differences were found between programs in moderate and vigorous intensities. Regarding the effects of programs in decisions, greater improvements in decisions with the ball were found in TGFU compared to DI.",2020,"According to the Game Performance Evaluation Tool (GPET), significant improvements ( p  = 0.018, d = 3.78) of the attacking player with the ball in the percentage of change between groups in the unsuccessful execution in TGfU (% = -62.2) were observed compared with direct instruction (% = 14.2).","['Thirty under-12 football players participated in this study (age: 10.3 ± 0.45 years', 'U-12 Soccer Players']","['TGfU', '6 Weeks Direct Instruction and Teaching Games', 'direct instruction']","['light PA levels', 'Physical Activity and Tactical Behaviour', 'sedentary PA levels', 'physical activity (PA) levels']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]",,0.01403,"According to the Game Performance Evaluation Tool (GPET), significant improvements ( p  = 0.018, d = 3.78) of the attacking player with the ball in the percentage of change between groups in the unsuccessful execution in TGfU (% = -62.2) were observed compared with direct instruction (% = 14.2).","[{'ForeName': 'Juan Vicente', 'Initials': 'JV', 'LastName': 'Sierra-Ríos', 'Affiliation': 'Physical Education Department, Faculty of Education, University of Castilla-La Mancha, 16071 Cuenca, Spain.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Ezequiel', 'Initials': 'E', 'LastName': 'Rey', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, 36005 Pontevedra, Spain.'}, {'ForeName': 'Sixto', 'Initials': 'S', 'LastName': 'González-Víllora', 'Affiliation': 'Physical Education Department, Faculty of Education, University of Castilla-La Mancha, 16071 Cuenca, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17145008']
1423,32598472,"Randomized Controlled Trial of Compression Interventions for Managing Hand Burn Edema, as Measured by Bioimpedance Spectroscopy.","Compression, a common treatment of choice for the management of edema, is one intervention that is applied with little objective understanding of the optimal parameters of application or efficacy in acute burn wounds. The aim of this study was to determine the effectiveness of different methods of compression for the management of hand edema following burn injury. The primary hypothesis tested was that in acute hand burn injury, the application of cohesive bandage will reduce edema faster than a generic compression glove. It is a randomized controlled study of 100 patients presenting with hand burn injury. Compression was randomized to one of the three methods of application: 1) spiral application of Coban to fingers, figure of eight to hand and wrist; 2) pinch application of Coban to fingers, spiral application to hand and wrist; or 3) a generic compression glove (control condition). Bioimpedance spectroscopy was used to measure hand volumes. Hand and wrist range of movement, pain scores, and QuickDASH were recorded. One hundred patients (68 males) demonstrated significant reductions in hand volumes, using all compression methods. Both methods of applying Coban resulted in significantly greater reductions in edema compared to the generic compression glove. Notwithstanding compression method, all range of movement measures improved, with significant improvement in thumb opposition (P = .046), hand span (P = .020), and wrist flexion (P = .020). QuickDASH decreased between sessions (P < .001). Different methods of applying Coban are superior to generic compression gloves for managing acute hand burn edema.",2020,"Notwithstanding compression method, all ROM measures improved, with significant improvement in thumb opposition (p=0.046), hand span (p=0.020) and wrist flexion (p=0.020).","['100 patients presenting with hand burn injury', 'hand edema following burn injury']","['generic compression glove (control condition', 'compression interventions']","['edema', 'ROM measures', 'Hand and wrist range of movement, pain scores and QuickDASH', 'hand span (p=0.020) and wrist flexion', 'thumb opposition', 'QuickDASH', 'Bioimpedance spectroscopy (BIS']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0274089', 'cui_str': 'Burn of hand'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0239819', 'cui_str': 'Edema of hand'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}]","[{'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C3880512', 'cui_str': 'Compression glove'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0427082', 'cui_str': 'Opposition of thumb'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}]",100.0,0.0418211,"Notwithstanding compression method, all ROM measures improved, with significant improvement in thumb opposition (p=0.046), hand span (p=0.020) and wrist flexion (p=0.020).","[{'ForeName': 'Dale O', 'Initials': 'DO', 'LastName': 'Edwick', 'Affiliation': 'State Adult Burns Unit, Fiona Stanley Hospital, Murdoch, Western Australia.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Hince', 'Affiliation': 'Institute of Health Research, The University of Notre Dame Australia, Fremantle, Western Australia.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Rawlins', 'Affiliation': 'State Adult Burns Unit, Fiona Stanley Hospital, Murdoch, Western Australia.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Wood', 'Affiliation': 'State Adult Burns Unit, Fiona Stanley Hospital, Murdoch, Western Australia.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Edgar', 'Affiliation': 'State Adult Burns Unit, Fiona Stanley Hospital, Murdoch, Western Australia.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/iraa104']
1424,32609960,"The SNAP 101 Double-Blind, Placebo/Active-Controlled, Safety, Pharmacokinetic, and Pharmacodynamic Study of INP105 (Nasal Olanzapine) in Healthy Adults.","OBJECTIVE


INP105 is a drug-device combination of olanzapine and technology that delivers a powder formulation of olanzapine to the vascular-rich upper nasal space. This study evaluated the pharmacokinetics, pharmacodynamics, safety, and tolerability of single ascending doses of INP105, olanzapine intramuscular (OLZ IM), and olanzapine oral disintegrating tablet (OLZ ODT).
METHODS


This was a phase 1, active and double-blind placebo comparator-controlled, ascending-dose, 2-period, incomplete-block, 1-way crossover study in 40 healthy subjects, randomized to single doses of OLZ IM (5 or 10 mg) or OLZ ODT (10 mg) in Period 1 and then 1 of 3 doses (5 mg, 10 mg, or 15 mg) of INP105 or placebo in Period 2 between July and October 2018. Sedation and attention were evaluated by visual analog scale (VAS), the Agitation/Calmness Evaluation Scale (ACES), and the Digit Symbol Substitution Test (DSST).
RESULTS


At equivalent doses, INP105 provided similar area under the drug concentration-time curve (AUC) from time 0 to the last measurable concentration, AUC from time 0 to infinity, and maximum observed concentration (Cmax) as OLZ IM and greater Cmax than but similar AUCs to OLZ ODT. Median time to maximum concentration was less for INP105 (15, 10, and 9.5 min for 5 mg, 10 mg, and 15 mg, respectively) than for OLZ IM (20 and 15 min for 5 mg and 10 mg, respectively) or OLZ ODT (120 min). Effects as measured with the VAS, ACES, and DSST with INP105 5 mg were comparable to those with OLZ IM 5 mg, with earlier onset for INP105 10 mg and 15 mg and greater effects than placebo and OLZ ODT. The incidence of treatment-emergent adverse events with INP105 5 mg, 10 mg, and 15 mg was 80%, 66.7%, and 75%, respectively, compared to 90% and 100% for OLZ IM 5 mg and 10 mg, respectively, and 83.3% for OLZ ODT; most common were dizziness, hypotension, and orthostatic symptoms.
CONCLUSIONS


INP105 has rapid absorption and pharmacodynamic effects and may represent an effective, convenient, noninvasive, and well-tolerated alternative for treating acutely agitated patients by self- or caregiver administration in the home, community, or hospital environments.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03624322.",2020,"At equivalent doses, INP105 provided similar area under the drug concentration-time curve (AUC) from time 0 to the last measurable concentration, AUC from time 0 to infinity, and maximum observed concentration (Cmax) as OLZ IM and greater Cmax than but similar AUCs to OLZ ODT.","['Healthy Adults', '40 healthy subjects']","['olanzapine', 'OLZ ODT', 'INP105, olanzapine intramuscular (OLZ IM), and olanzapine oral disintegrating tablet (OLZ ODT', 'OLZ IM', 'INP105', 'INP105 or placebo', 'INP105 (Nasal Olanzapine', 'placebo']","['Median time to maximum concentration', 'incidence of treatment-emergent adverse events', 'dizziness, hypotension, and orthostatic symptoms', 'visual analog scale (VAS), the Agitation/Calmness Evaluation Scale (ACES), and the Digit Symbol Substitution Test (DSST', 'pharmacokinetics, pharmacodynamics, safety, and tolerability', 'INP105 provided similar area under the drug concentration-time curve (AUC', 'rapid absorption and pharmacodynamic effects']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0991504', 'cui_str': 'Disintegrating Oral Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",40.0,0.158513,"At equivalent doses, INP105 provided similar area under the drug concentration-time curve (AUC) from time 0 to the last measurable concentration, AUC from time 0 to infinity, and maximum observed concentration (Cmax) as OLZ IM and greater Cmax than but similar AUCs to OLZ ODT.","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Shrewsbury', 'Affiliation': 'Stephen B. Shrewsbury, Impel NeuroPharma, Inc, 201 Elliott Ave West, Ste 260, Seattle, WA 98119. sshrewsbury@impelnp.com.'}, {'ForeName': 'Jasna', 'Initials': 'J', 'LastName': 'Hocevar-Trnka', 'Affiliation': 'Impel NeuroPharma, Inc, Seattle, Washington, USA.'}, {'ForeName': 'Kelsey H', 'Initials': 'KH', 'LastName': 'Satterly', 'Affiliation': 'Impel NeuroPharma, Inc, Seattle, Washington, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Craig', 'Affiliation': 'Impel NeuroPharma, Inc, Seattle, Washington, USA.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hoekman', 'Affiliation': 'Impel NeuroPharma, Inc, Seattle, Washington, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13086']
1425,32615357,Impact of salt substitute and stepwise reduction of salt supply on blood pressure in residents in senior residential facilities: Design and rationale of the DECIDE-Salt trial.,"BACKGROUND


High sodium intake has been considered as the leading dietary risk factor for deaths and disability-adjusted life-years among older adults. High-quality randomized trials to evaluate the effects of practical sodium reduction strategies are needed.
METHODS


The study is a cluster randomized trial with a 2 × 2 factorial design conducted in 48 senior residential facilities in northern China. These facilities are randomly assigned (1:1:1:1) to 1 of 4 groups: stepwise salt supply control (SSSC) in which 5%-10% of the study salt supply in the institutional kitchens will be reduced every 3 months, replacing normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS. The interventions last for 2 years with follow-up every 6 months. The primary outcome is the change in systolic blood pressure from baseline to 24 months. Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
CURRENT STATUS


The study has recruited and randomized 48 senior residential facilities with 1,606 participants. Mean age at baseline was 71 years, and 76% are male. Both types of salt intervention were initiated in the study facilities between January and April 2018.
CONCLUSION


The study is well placed to define the effects of 2 practical and scalable sodium reduction strategies for blood pressure reduction and will provide important new data about safety of these strategies among older adults in China.",2020,"Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
","['Mean age at baseline was 71\u202fyears, and 76% are male', '48 senior residential facilities with 1,606 participants', 'residents in senior residential facilities', 'older adults in China', '48 senior residential facilities in northern China']","['salt substitute and stepwise reduction of salt supply', 'salt intervention', 'stepwise salt supply control (SSSC', 'normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS']","['blood pressure', 'change in systolic blood pressure', 'blood pressure reduction', 'incidence of hyperkalemia, hyponatremia, cardiovascular events, and death']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",48.0,0.0400665,"Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
","[{'ForeName': 'Aoming', 'Initials': 'A', 'LastName': 'Jin', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Kiang', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Darwin R', 'Initials': 'DR', 'LastName': 'Labarthe', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Xiangxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Hohhot Center for Disease Control and Prevention, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Qianku', 'Initials': 'Q', 'LastName': 'Qiao', 'Affiliation': 'Yangcheng Ophthalmology Hospital, Shanxi, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'China Center for Health Development Studies, Peking University, Beijing, China.'}, {'ForeName': 'Peifen', 'Initials': 'P', 'LastName': 'Duan', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Hohhot Center for Disease Control and Prevention, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Lae', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Yangcheng Ophthalmology Hospital, Shanxi, China.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, Australia, Sydney, Australia; The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Junshi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'National Center for Food Safety Risk Assessment, Beijing, China.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China; Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China. Electronic address: wuyf@bjmu.edu.cn.'}]",American heart journal,['10.1016/j.ahj.2020.05.013']
1426,32615392,The effects of 6 mo of supplementation with probiotics and synbiotics on gut microbiota in the adults with prediabetes: A double blind randomized clinical trial.,"OBJECTIVES


The evidence of 16S rRNA genes in the gut microbiota distinguished a higher Firmicutes-to-Bacteroidetes ratio in individuals who were obese and had diabetes than in a healthy cohort. So, it seems that the modulation of intestinal microbial ecology by pro-/pre-/synbiotics may contribute to the progression and prevention of metabolic diseases. The aim of this study was to assess the effects of probiotics and synbiotic supplementation on the modification of the intestinal microbiome in adults with prediabetes.
METHODS


In a randomized, double-blinded, placebo-controlled clinical trial, 120 patients with prediabetes were randomly assigned to consume 6 g/d of either a placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic for 6 mo. Fecal samples were obtained at baseline and after 6 mo of supplementation. Dietary intake was assessed throughout the study (at baseline and after 3 and 6 mo). Total energy, macronutrients, and dietary fiber were calculated using a dietary program Nutritionist 4. DNA was extracted from fecal samples and the numbers of Clostridium perfringens (the represent of phylum Firmicutes), Bacteroides fragilis (the representative of Bacteroidetes) and Escherichia coli (as universal bacteria) were determined by quantitative real-time polymerase chain reactions (qPCR). The changes in the relative abundance of the two fecal bacteria before and after supplementation were analyzed and compared within and between groups.
RESULTS


There were no significant changes in dietary intake during the study. Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02). Synbiotic had no significant effect on the changes in the bacteria. There were no significant differences between the three groups.
CONCLUSION


The results of this study suggest that manipulation of the human gut microbiome by using probiotics could provide a potential therapeutic approach in the prevention and management of obesity and metabolic disorders such as diabetes.",2020,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","['120 patients with prediabetes', 'adults with prediabetes']","['dietary program', 'probiotics and synbiotic supplementation', 'placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic', 'Synbiotic', 'supplementation with probiotics and synbiotics', 'placebo']","['dietary intake', 'gut microbiota', 'bacteria', 'Total energy, macronutrients, and dietary fiber', 'abundance of the B. fragilis-to-E.coli ratio', 'Dietary intake', 'Fecal samples']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",120.0,0.249584,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","[{'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Kassaian', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: nkassaian@gmal.com.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center and Department of Biostatistics and Epidemiology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: awat_feiz@hlth.mui.ac.ir.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Rostami', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: srostami1876@gmail.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: aminorroaya@med.mui.ac.ir.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Yaran', 'Affiliation': 'Nosocomial Infection Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: yaranmajid@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: M_amini@med.mui.ac.ir.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110854']
1427,32619212,"Contrasting effects of viscous and particulate fibers on colonic fermentation in vitro and in vivo, and their impact on intestinal water studied by MRI in a randomized trial.","BACKGROUND


Wheat bran, nopal, and psyllium are examples of particulate, viscous and particulate, and viscous fibers, respectively, with laxative properties yet contrasting fermentability.
OBJECTIVES


We assessed the fermentability of these fibers in vitro and their effects on intestinal function relevant to laxation in vivo using MRI.
METHODS


Each fiber was predigested prior to measuring gas production in vitro during 48-h anaerobic incubation with healthy fecal samples. We performed a randomized, 3-way crossover trial in 14 healthy volunteers who ingested 7.5 g fiber twice on the day prior to study initiation and once with the study test meal. Serial MRI scans obtained after fasting and hourly for 4 h following meal ingestion were used to assess small bowel water content (SBWC), colonic volumes, and T1 of the ascending colon (T1AC) as measures of colonic water. Breath samples for hydrogen analysis were obtained while patients were in the fasted state and every 30 min for 4 h following meal ingestion.
RESULTS


In vitro, the onset of gas production was significantly delayed with psyllium (mean ± SD: 14 ± 5 h) compared with wheat bran (6 ± 2 h, P = 0.003) and was associated with a smaller total gas volume (P = 0.01). Prefeeding all 3 fibers for 24 h was associated with an increased fasting T1AC (>75% of values >90th centile of the normal range). There was a further rise during the 4 h after psyllium (0.3 ± 0.3 s P = 0.009), a fall with wheat bran (-0.2 ± 0.2 s; P = 0.02), but no change with nopal (0.0 ± 0.1 s, P = 0.2). SBWC increased for all fibers; nopal stimulated more water than wheat bran [AUC mean (95% CI) difference: 7.1 (0.6, 13.8) L/min, P = 0.03].Breath hydrogen rose significantly after wheat bran and nopal but not after psyllium (P < 0.0001).
CONCLUSION


Both viscous and particulate fibers are equally effective at increasing colonic T1 over a period of 24 h. Mechanisms include water trapping in the small bowel by viscous fibers and delivery of substrates to the colonic microbiota by more fermentable particulate fiber. This trial was registered at clinicaltrials.gov as NCT03263065.",2020,Both viscous and particulate fibers are equally effective at increasing colonic T1 over a period of 24 h. Mechanisms include water trapping in the small bowel by viscous fibers and delivery of substrates to the colonic microbiota by more fermentable particulate fiber.,['14 healthy volunteers who ingested 7.5 g fiber twice on the day prior to study initiation and once with the study test meal'],['viscous and particulate fibers'],"['increased fasting T1AC', 'onset of gas production', 'SBWC', 'smaller total gas volume', 'small bowel water content (SBWC), colonic volumes, and T1 of the ascending colon (T1AC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0227375', 'cui_str': 'Ascending colon structure'}]",14.0,0.0430021,Both viscous and particulate fibers are equally effective at increasing colonic T1 over a period of 24 h. Mechanisms include water trapping in the small bowel by viscous fibers and delivery of substrates to the colonic microbiota by more fermentable particulate fiber.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gunn', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Murthy', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Major', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Wilkinson-Smith', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hoad', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marciani', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Remes-Troche', 'Affiliation': 'Digestive Physiology and Motility Lab, Medical Biological Research Institute, University of Veracruz, Veracruz, Mexico.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Harris', 'Affiliation': 'Quadram Institute of Biosciences, Food, Innovation and Health, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ahn-Jarvis', 'Affiliation': 'Quadram Institute of Biosciences, Food, Innovation and Health, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Warren', 'Affiliation': 'Quadram Institute of Biosciences, Food, Innovation and Health, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Spiller', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa173']
1428,32622171,Change in core symptoms of borderline personality disorder by tDCS: A pilot study.,"Borderline personality disorder (BPD) recognizes several psychopathological dimensions related to prefrontal cortex impairments. Transcranial Direct Current Stimulation (tDCS) targeting the right prefrontal dorsolateral cortex (DLPFC) positively influence cognitive functions related to impulsivity in healthy subjects. A randomized double-blind study was designed to investigate whether tDCS could modulate core dimensions (impulsivity, aggression, affective dysregulation) of BPD. Also effects on decision making process and substances craving was assessed. Patients were randomized to receive active-tDCS at 2 mA versus sham-tDCS, once a day for 15 sessions. Anode was placed on the right DLPFC (F4), cathode on the left DLPFC (F3). Impulsivity and aggression measures were significantly reduced only in patients treated with active-tDCS. Decision-making process was marginally influenced by the active current. Craving intensity was reduced only in the active-tDCS sample. Both groups showed improvements in the affective dysregulation dimension and anxious and depressive symptoms. The application of bilateral tDCS targeting right DLPFC with anodal stimulation seems to improve core dimensions of BPD (mainly impulsivity and aggression) probably by restoring prefrontal activity. tDCS might be a potential tool for preventing self-harming behaviors.",2020,Both groups showed improvements in the affective dysregulation dimension and anxious and depressive symptoms.,['healthy subjects'],"['Transcranial Direct Current Stimulation (tDCS', 'active-tDCS at 2\xa0mA versus sham-tDCS', 'tDCS']","['Craving intensity', 'Impulsivity and aggression measures', 'decision making process and substances craving', 'affective dysregulation dimension and anxious and depressive symptoms', 'core dimensions (impulsivity, aggression, affective dysregulation) of BPD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}]",,0.0377358,Both groups showed improvements in the affective dysregulation dimension and anxious and depressive symptoms.,"[{'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Lisoni', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy. Electronic address: jacopo.lisoni@gmail.com.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Miotto', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy. Electronic address: miottopaola@yahoo.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barlati', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: stefano.barlati@unibs.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Calza', 'Affiliation': 'Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: stefano.calza@unibs.it.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Crescini', 'Affiliation': 'Department of Mental Health, ASST Valcamonica, Esine, Italy. Via Manzoni 142, Esine, Brescia ITALY.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Deste', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy. Electronic address: giacomodeste@mac.com.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Sacchetti', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: emilio.sacchetti@unibs.it.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Vita', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: antonio.vita@unibs.it.'}]",Psychiatry research,['10.1016/j.psychres.2020.113261']
1429,32624244,"Effect of a Fluocinolone Acetonide Insert on Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis: Three-Year Results.","PURPOSE


To examine the 36-month efficacy and safety of a 0.2 μg/day fluocinolone acetonide insert (FAi) to treat noninfectious uveitis of the posterior segment (NIU-PS).
DESIGN


Phase 3, prospective, double-masked, multicenter study (clinicaltrials.gov, NCT01694186).
PARTICIPANTS


Adults (≥18 years old) with a diagnosis of NIU-PS in ≥1 eye for ≥1 year and ≥2 recurrences of uveitis requiring systemic corticosteroid, immunosuppressive treatment, or intraocular corticosteroids.
METHODS


Participants were randomized 2:1 to FAi or sham (injection plus standard of care) treatment.
MAIN OUTCOME MEASURES


The primary outcome was the difference between the proportion of FAi-treated and sham-treated patients who had a uveitis recurrence. Secondary outcomes included time to first recurrence, number of recurrences, best-corrected visual acuity (BCVA) change from baseline, resolution of macular edema, and number of adjunctive treatments.
RESULTS


One hundred twenty-nine participants (n = 87 FAi-treated; n = 42 sham-treated) were enrolled. Over 36 months of treatment, cumulative uveitis recurrences were significantly reduced with FAi compared with sham (65.5% vs. 97.6%, respectively; P < 0.001); time to first recurrence was commensurately longer (median 657.0 and 70.5 days, respectively; P < 0.001). The number of recurrences per eye was significantly lower in the FAi-treated compared with the sham-treated group (mean 1.7 vs. 5.3, respectively, P < 0.001). At 36 months, more FAi-treated eyes had a ≥15-letter increase in BCVA from baseline and fewer FAi-treated eyes had investigator-determined macular edema at month 36 compared with sham-treated eyes (33.3% vs. 14.7% and 13.0% vs. 27.3% for BCVA and macular edema, respectively). Fewer FAi compared with sham-treated participants required adjunctive treatments (57.5% vs. 97.6%, respectively). Intraocular pressure (IOP) was similar for both study groups at month 36 (mean ± standard deviation 14.5±5.1 and 14.8±5.3, respectively), and approximately half as many eyes in the FAi-treated group when compared with the sham-treated group underwent IOP-lowering surgery (5.7% vs. 11.9%). Cataract surgery was required more frequently over 36 months in the FAi-treated compared with the sham-treated group (73.8% vs. 23.8% of eyes, respectively).
CONCLUSIONS


Fluocinolone acetonide insert-treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes.",2020,"Fluocinolone acetonide insert-treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes.","['One hundred twenty-nine participants (n\xa0= 87', 'Participants', 'Adults (≥18 years old) with a diagnosis of NIU-PS in ≥1 eye for ≥1 year and ≥2 recurrences of uveitis requiring systemic corticosteroid, immunosuppressive treatment, or intraocular corticosteroids', 'FAi-treated; n\xa0= 42 sham-treated) were enrolled']","['Fluocinolone acetonide', 'FAi or sham (injection plus standard of care) treatment', 'fluocinolone acetonide insert (FAi', 'Fluocinolone Acetonide', 'FAi']","['time to first recurrence', 'Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis', 'time to first recurrence, number of recurrences, best-corrected visual acuity (BCVA) change from baseline, resolution of macular edema, and number of adjunctive treatments', 'macular edema', 'uveitis recurrence', 'cumulative uveitis recurrences', 'number of recurrences per eye', 'BCVA', 'Intraocular pressure (IOP', 'recurrence-free durations, fewer recurrence episodes', 'uveitis recurrence rates', '36-month efficacy and safety', 'Cataract surgery']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0016298', 'cui_str': 'fluocinolone acetonide'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]",129.0,0.488521,"Fluocinolone acetonide insert-treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes.","[{'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University Eye Center, Duke University, Durham, North Carolina. Electronic address: jaffe001@mc.duke.edu.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Pavesio', 'Affiliation': 'Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.04.001']
1430,32634886,[Effect of systemic use of amoxicillin and metronidazole during mechanical therapy on the periodontal microorganisms in subgingival plaque and saliva of patients with aggressive periodontitis].,"Objective:  To explore the effect of systemic use of amoxicillin and metronidazole during mechanical therapy on the clinical parameters of the first molars and periodontal microorganisms in subgingival plaque and saliva in patients with generalized aggressive periodontitis (GAgP).  Methods:  A total of 23 GAgP patients were recruited from Peking University School and Hospital of Stomatology from January 2006 to December 2009 and then randomly divided into two groups according to random number table: 12 patients received scaling and root planning (SRP) only and 11 patients received SRP combined with systemic administration of antibiotics (amoxicillin and metronidazole for a week after supragingival scaling). Clinical examination of periodontal parameters and collection of saliva and pooled subgingival plaque samples from mesial-buccal sites of 4 first molars were performed before initial therapy and 2, 4 and 6 months respectively after mechanical therapy, and saliva samples were also collected 2 weeks after therapy. Eight different periodontal microorganisms were detected in these samples by PCR. In addition, semiquantitative analysis of red complex microorganisms [ Porphyromonas gingivalis  (Pg),  Tannerella forsythia  (Tf),  Treponema denticola  (Td)] was performed.  Results:  Both therapies led to significant decrease of the plaque index (PLI), probing depth (PD) and bleeding index (BI) from mesial-buccal sites of first molars. Meanwhile the PD of antibiotics group [(4.21±1.50), (4.00±1.54), (3.84±1.89) mm of 2, 4 and 6 months respectively after therapy] was significantly lower than the SRP group [(5.29±1.27), (5.30±1.34), (4.98±1.36) mm of 2, 4 and 6 months respectively after therapy] at 3 different time points after mechanical therapy ( P <0.05). In the antibiotics group, the quantities of Pg, Tf and Td in subgingival plaque samples (the median quantity decreased to 0.0 ng at 2, 4 and 6 months after therapy) and saliva samples (the median quantity of Tf and Td decreased to 0.0 ng at 2, 4 and 6 months after therapy ( P <0.05), and the median quantity of Pg decreased to 16.3, 59.6 and 22.4 ng at 2, 4 and 6 months respectively after therapy) significantly decreased at 3 different time points after mechanical therapy compared with before therapy ( P< 0.05). While in the SRP group, there were no significant changes in the quantities of Tf and Td in saliva at 2, 4 and 6 months after mechanical therapy ( P >0.05) , and the quantities of Tf and Td in subgingival plaque significantly decreased only at 2 months after therapy ( P <0.05).  Conclusions:  SRP combined with systemic administration of amoxicillin and metronidazole could achieve greater improvement in PD of first molars and better control of the amounts of red complex microorganisms in the saliva and subgingival plaque of GAgP patients over a 6-month period.",2020,"Both therapies led to significant decrease of the plaque index (PLI), probing depth (PD) and bleeding index (BI) from mesial-buccal sites of first molars.","['patients with generalized aggressive periodontitis (GAgP', 'mesial-buccal sites of 4 first molars', '23 GAgP patients were recruited from Peking University School and Hospital of Stomatology from January 2006 to December 2009', 'patients with aggressive periodontitis']","['SRP', 'scaling and root planning (SRP', 'amoxicillin and metronidazole', 'SRP combined with systemic administration of antibiotics (amoxicillin and metronidazole']","['Tf),  Treponema denticola  (Td', 'saliva samples', 'semiquantitative analysis of red complex microorganisms [ Porphyromonas gingivalis  (Pg),  Tannerella forsythia  ', 'quantities of Tf and Td in subgingival plaque', 'median quantity', 'median quantity of Pg', 'plaque index (PLI), probing depth (PD) and bleeding index (BI', 'quantities of Pg, Tf and Td in subgingival plaque samples', 'quantities of Tf and Td in saliva']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}, {'cui': 'C0447318', 'cui_str': 'Mesial-buccal'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}]","[{'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}]","[{'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0085478', 'cui_str': 'Porphyromonas gingivalis'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",23.0,0.0337855,"Both therapies led to significant decrease of the plaque index (PLI), probing depth (PD) and bleeding index (BI) from mesial-buccal sites of first molars.","[{'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Feng', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Lu', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'Z B', 'Initials': 'ZB', 'LastName': 'Chen', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}, {'ForeName': 'H X', 'Initials': 'HX', 'LastName': 'Meng', 'Affiliation': 'Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing 100081, China.'}]",Zhonghua kou qiang yi xue za zhi = Zhonghua kouqiang yixue zazhi = Chinese journal of stomatology,['10.3760/cma.j.cn112144-20200325-00171']
1431,32648662,Effect of losartan on the recoverability of renal function in anuric and oliguric patients with a solitary obstructed kidney: a double-blind randomized placebo-controlled trial.,"OBJECTIVES


To assess the role of the angiotensin receptor blocker losartan on the recoverability of renal function after de-obstruction in patients with anuria and oliguria.
MATERIALS AND METHODS


This was a double-blind randomized placebo-controlled trial in anuric or oliguric patients with calcular obstruction of solitary kidney. Patients with an anomalous kidney or those with an American Society of Anesthesiology score of >3 were excluded. After relief of obstruction, patients were allocated to receive either losartan potassium 25 mg or placebo for 3 months. Serum creatinine (sCr) and renographic glomerular filtration rate (GFR) were measured at nadir and after 3 months. Changes in sCr and renographic GFR were calculated by subtracting the values at nadir from those at 3 months. Improvement, stabilization or deterioration of sCr and renographic GFR were defined as percentage increase or decrease from nadir ≥10%, while changes <10% were considered as stabilization.
RESULTS


A total of 76 patients completed 3 months of follow-up. Demographics and peri-operative data were comparable in the two groups. The median (range) sCr change was -1.05 (-1.8, 0.4) and -0.5 (-1.3, 0.1) mg/dL in the losartan and placebo, groups, respectively (P = 0.07). In the losartan group, renographic GFR had improved in 26 (59.1%) and deteriorated in six (13.6%) patients, while, in the placebo group, it had improved in eight (25%) and deteriorated in 10 patients (31.3%; P = 0.01). Losartan also enhanced renographic GFR improvement vs placebo by a median (range) of 6.9 (-9, 44) vs 1.4 (-10, 32) mL/min (P = 0.004).
CONCLUSIONS


In patients with anuria and oliguria, losartan treatment contributes to renal function recoverability after relief of calcular obstruction of the solitary kidney.",2020,"Losartan had also enhanced Re GFR (median, range) change by 6.9 (-9, 44) versus 1.4 (-10, 32)","['76 patients had completed 3 months follow-up', 'Patients with anomalous kidney or those with ASA score of >3 were excluded', 'anuric and oliguric patients with solitary obstructed kidney', 'anuric and oliguric patients', 'oliguric patients with calculuar obstruction of solitary kidney']","['Angiotensin receptor blockade (ARB), losartan', 'Losartan', 'losartan potassium 25 mg or placebo', 'losartan', 'placebo']","['renal function', 'enhanced Re GFR', 'Serum creatinine (S.creat), renographic glomerular filtration rate (Re GFR', 'deterioration of Re GFR', 'Changes of S.creat and Re GFR', 'Improvement, stabilization or deterioration of S.creat and Re GFR']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0266294', 'cui_str': 'Renal agenesis, unilateral'}]","[{'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C2912327', 'cui_str': 'Losartan Potassium 25 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]",76.0,0.454264,"Losartan had also enhanced Re GFR (median, range) change by 6.9 (-9, 44) versus 1.4 (-10, 32)","[{'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Elkappany', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Abdelwahab', 'Initials': 'A', 'LastName': 'Hashem', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elkarta', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Sheashaa', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Osman', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Shokeir', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}]",BJU international,['10.1111/bju.15168']
1432,32648821,Impacts of prolonged sitting with mild hypercapnia on vascular and autonomic function in healthy recreationally active adults.,"Prolonged sitting, which is known to impair peripheral vascular function, often occurs in spaces (e.g., offices) with mild hypercapnic atmospheres. However, the effects of prolonged sitting in hypercapnic conditions on vascular function are unknown. Therefore, the purpose of this study was to investigate the effects of prolonged sitting in mild hypercapnic conditions on vascular and autonomic function in humans. Twelve healthy young adults participated in two experimental visits that consisted of sitting for 2.5 h in a control condition [normal atmospheric conditions sitting (PSIT)] or a mild hypercapnic condition (HCAP; CO 2  = 1,500 ppm). During each visit, heart rate variability (HRV), blood pressure (BP), pulse wave velocity (PWV), augmentation index (AIx), brachial and popliteal artery flow-mediated dilation (FMD), and near-infrared spectroscopy (NIRS) were assessed before and after prolonged sitting. Sitting significantly decreased AIx in both groups ( P  < 0.05). Brachial and popliteal FMD were reduced with sitting ( P  < 0.05), and the reduction in popliteal FMD was amplified by HCAP ( P  < 0.05). Baseline microvascular oxygenation was decreased following sitting in both groups ( P  < 0.05). However, microvascular reoxygenation upon cuff release was slower only in HCAP ( P  < 0.05). HRV, HR, BP, and PWV did not significantly change with sitting in either group ( P  > 0.05). We conclude that prolonged sitting attenuated both brachial and popliteal endothelial function and was associated with perturbed microcirculation. Additionally, mild hypercapnic conditions further impaired peripheral endothelial and microvascular function. Together, these findings suggest that prolonged sitting is accompanied by a host of deleterious effects on the vasculature, which are exacerbated by mild hypercapnia. NEW & NOTEWORTHY  The results of this study reveal that prolonged sitting attenuates endothelial function and microvascular function. Additionally, prolonged sitting with mild hypercapnia, which is similar to everyday environments, further exacerbates peripheral endothelial function and microvascular function.",2020,Baseline microvascular oxygenation was decreased following sitting in both groups (P<0.05).,"['12 healthy young adults', 'healthy recreationally active adults', 'humans']","['experimental visits which consisted of sitting for 2.5 hours in a control condition (PSIT) or a mild hypercapnic condition (HCAP, CO2=1,500 ppm', 'prolonged sitting with mild hypercapnia']","['reduction in popliteal FMD', 'Prolonged sitting attenuated both brachial and popliteal endothelial function', 'peripheral endothelial and microvascular function', 'Brachial and popliteal FMD', 'HRV, HR, BP, and PWV', 'microvascular reoxygenation upon cuff release', 'vascular and autonomic function', 'Baseline microvascular oxygenation', 'heart rate variability (HRV), blood pressure (BP), pulse wave velocity (PWV), augmentation index (AIx), brachial and popliteal artery flow mediated dilation (FMD), and near infrared spectroscopy (NIRS']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0056451', 'cui_str': 'H-CAP protocol'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]",12.0,0.0577376,Baseline microvascular oxygenation was decreased following sitting in both groups (P<0.05).,"[{'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Headid', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'TeSean K', 'Initials': 'TK', 'LastName': 'Wooden', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Layec', 'Affiliation': 'Department of Kinesiology, University of Massachusetts, Amherst, Massachusetts.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Wiess School of Natural Sciences, Rice University, Houston, Texas.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00354.2020']
1433,32649961,The effect of platelet-rich plasma on female androgenetic alopecia: A randomized controlled trial.,"BACKGROUND


Platelet-rich plasma (PRP) may be a useful treatment for androgenetic alopecia (AGA), although objective studies are needed.
OBJECTIVE


To determine whether PRP injections improve female AGA.
METHOD


Prospective randomized controlled trial of 30 women diagnosed with AGA. Patients received subdermal scalp injections of Eclipse system PRP or placebo saline at weeks 0, 4, and 8. Outcome measures were changes in hair density (hair/cm 2 ), hair caliber (mm), and blinded global photographic assessment (improved or not improved) at week 24.
RESULTS


Blinded global photographic assessment indicated that 57% of patients receiving PRP versus 7% of patients receiving saline improved at week 24 from baseline (P < .01). Compared to baseline, there was improvement in mean density in the PRP group versus the placebo group at week 8 (+71.1 vs -26.7 hairs/cm 2 ; P < .01) and week 24 (+105.9 vs -52.4 hairs/cm 2 ; P < .01). Compared to baseline, there was improvement in mean caliber in the PRP group versus the placebo group at week 8 (+0.0043 vs -0.0034 mm; P < .01) and week 24 (+0.0053 vs -0.0060 mm; P < .01). Adverse effects included headache, scalp tightness, swelling, redness, and postinjection bleeding.
LIMITATIONS


Two patients lost to follow-up.
CONCLUSIONS


PRP with the Eclipse system is a safe and effective intervention for female AGA.",2020,"Compared to baseline, there was improvement in mean caliber in the PRP group vs. the placebo group at week 8 (+0.0043 vs. -0.0034 mm, p<0.01) and week 24 (+0.0053 vs. -0.0060 mm, p<0.01).","['30 females diagnosed with AGA', 'female androgenetic alopecia', 'androgenetic alopecia (AGA']","['subdermal scalp injections of Eclipse system PRP or placebo saline', 'PRP injections', 'platelet-rich plasma', 'placebo']","['mean caliber', 'headache, scalp tightness, swelling, redness, and post-injection bleeding', 'mean density', 'changes in hair density (hair/cm 2 ), hair caliber (mm), and blinded global photographic assessment']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",30.0,0.356908,"Compared to baseline, there was improvement in mean caliber in the PRP group vs. the placebo group at week 8 (+0.0043 vs. -0.0034 mm, p<0.01) and week 24 (+0.0053 vs. -0.0060 mm, p<0.01).","[{'ForeName': 'Danielle P', 'Initials': 'DP', 'LastName': 'Dubin', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: DPDubin121@gmail.com.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Lin', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Hayley M', 'Initials': 'HM', 'LastName': 'Leight', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Farberg', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York; Arkansas Dermatology, Little Rock, Arkansas.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Torbeck', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Burton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Khorasani', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.1021']
1434,32652112,"Identifying oncogenic drivers associated with increased risk of late distant recurrence in postmenopausal, estrogen receptor-positive, HER2-negative early breast cancer: results from the BIG 1-98 study.","BACKGROUND


In postmenopausal, estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer, the risk for distant recurrence can extend beyond 5 years of adjuvant endocrine therapy. This study aims to identify genomic driver alterations associated with late distant recurrence.
PATIENTS AND METHODS


Next generation sequencing was used to characterize driver alterations in primary tumors from a subset of 764 postmenopausal estrogen receptor-positive/HER2-negative patients from the BIG 1-98 randomized trial. Late distant recurrence events were defined as ≥5 years from time of randomization). The association of driver alterations with distant recurrence-free interval in early and late time periods was assessed using Cox regression models. Multivariable analyses were carried out to adjust for clinicopathological factors. Weighted analysis methods were used in order to correct for over-sampling of distant recurrences.
RESULTS


A total of 538 of 764 (70%) samples were successfully sequenced including 88 (63%) early and 52 (37%) late distant recurrence events after a median follow up of 8.1 years. In univariable analysis for late distant recurrence, PIK3CA mutations (58.8%) were significantly associated with reduced risk [hazard ratio (HR) 0.40, 95% confidence interval (CI) 0.20-0.82, P = 0.012], whereas amplifications on chromosome 8p11 (10.9%) (HR 4.79, 95% CI 2.30-9.97, P < 0.001) and BRCA2 mutations (2.3%) (HR 5.39, 95% CI 1.51-19.29, P = 0.010) were significantly associated with an increased risk. In multivariable analysis, only amplifications on 8p11 (P = 0.002) and BRCA2 mutations (P = 0.013) remained significant predictors.
CONCLUSIONS


In estrogen receptor-positive/HER2-negative postmenopausal early breast cancer, PIK3CA mutations were associated with reduced risk of late distant recurrence, whereas amplifications on 8p11 and BRCA2 mutations were associated with increased risk of late distant recurrence. The characterization of oncogenic driver alterations may aid in refining treatment choices in the late disease setting, and help identify potential drug targets for testing in future trials.",2020,"In multivariable analysis, only amplifications on 8p11 (P=0.002) and BRCA2 mutations (P=0.013) remained significant predictors.
",['primary tumors from a subset of 764 postmenopausal ER+/HER2- patients from the BIG 1-98 randomized trial'],[],"['Late distant recurrence events', 'late distant recurrence events', 'risk of late distant recurrence', 'BRCA2 mutations']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1511024', 'cui_str': 'BRCA2 gene mutation'}]",,0.192938,"In multivariable analysis, only amplifications on 8p11 (P=0.002) and BRCA2 mutations (P=0.013) remained significant predictors.
","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Luen', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Savas', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kammler', 'Affiliation': 'International Breast Cancer Study Group, Coordinating Center, Central Pathology Office, Bern, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""Dell'Orto"", 'Affiliation': 'International Breast Cancer Study Group Central Pathology Office, Department of Pathology, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Biasi', 'Affiliation': 'Division of Pathology and Laboratory Medicine, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Demanse', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hackl', 'Affiliation': 'OncogenomX Inc., Allschwil, Basel, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thuerlimann', 'Affiliation': 'Breast Center, Cantonal Hospital, St Gallen, Switzerland; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'Department of Pathology, University of Milan, Milan, Italy; IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Leo', 'Affiliation': 'Sandro Pitigliani Department of Medical Oncology, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Division of Medical Senology, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Division of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia. Electronic address: sherene.loi@petermac.org.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.06.024']
1435,32657195,Improved adenoma detection with linked color imaging technology compared to white-light colonoscopy.,"OBJECTIVES


Linked color imaging (LCI) is a new endoscopic technology that may increase colorectal adenoma detection rate (ADR) and polyp detection rate (PDR) by virtual chromoendoscopy. Aim of the present study was to evaluate the effectiveness of LCI in ADR and PDR compared to the HD white-light colonoscopy (WLC) technique.
MATERIALS AND METHODS


Between October 2016 and June 2018, we enrolled consecutive outpatients prospectively. Eligible patients allocated randomly to undergo HD WLC or LCI colonoscopy technique during instrument withdrawal. Each colonoscopy was performed in a single center by the same three expert endoscopists (with expertise more than 5000 colonoscopies).
RESULTS


A total of 1278 patients underwent colonoscopy in the study period. ADR and PDR were significantly higher in the LCI group compared to the WLC group (34.4% vs. 26.8%;  p  = .007; and 53.3% vs 46.4%;  p  = .023, respectively). Similarly, the mean number of adenomas per patient (MAP) was significantly higher with the LCI than WLC (0.64 vs 0.44, respectively;  p  = .002). The mean age of patients at the time of colonoscopy was 51.95 years (SD = 13.861) in the LCI group and 51.96 years (SD = 14.028) in the WLC group. No significant differences observed in patient demographic characteristics (there was no difference in gender and age distribution,  p  = .986), quality of colonoscopy preparation and withdrawal times (WT) between the two groups (WLC and the LCI groups, 493.9 (SD: 143.5) and 514.0 (SD: 139.5) sec, respectively).
CONCLUSIONS


According to our results, LCI virtual chromoendoscopic technology was superior compared to conventional HD WLC in detecting colorectal polyps and adenomas.",2020,"No significant differences observed in patient demographic characteristics (there was no difference in gender and age distribution,  p  = .986), quality of colonoscopy preparation and withdrawal times (WT) between the two groups (WLC and the LCI groups, 493.9 (SD: 143.5) and 514.0 (SD: 139.5) sec, respectively).
","['Between October 2016 and June 2018, we enrolled consecutive outpatients prospectively', '1278 patients underwent colonoscopy in the study period']","['HD white-light colonoscopy (WLC) technique', 'LCI', 'conventional HD WLC', 'HD WLC or LCI colonoscopy technique', 'Linked color imaging (LCI', 'WLC']","['patient demographic characteristics', 'colorectal adenoma detection rate (ADR) and polyp detection rate (PDR', 'quality of colonoscopy preparation and withdrawal times (WT', 'ADR and PDR', 'mean number of adenomas per patient (MAP']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",1278.0,0.0214043,"No significant differences observed in patient demographic characteristics (there was no difference in gender and age distribution,  p  = .986), quality of colonoscopy preparation and withdrawal times (WT) between the two groups (WLC and the LCI groups, 493.9 (SD: 143.5) and 514.0 (SD: 139.5) sec, respectively).
","[{'ForeName': 'Barbara Dorottya', 'Initials': 'BD', 'LastName': 'Lovász', 'Affiliation': 'Institute of Applied Health Sciences, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Milán', 'Initials': 'M', 'LastName': 'Szalai', 'Affiliation': 'Endoscopy Unit, Endo-Kapszula Health Centre, Székesfehérvár, Hungary.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Oczella', 'Affiliation': 'Institute of Applied Health Sciences, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Ádám', 'Initials': 'Á', 'LastName': 'Finta', 'Affiliation': 'Endoscopy Unit, Endo-Kapszula Health Centre, Székesfehérvár, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Dubravcsik', 'Affiliation': 'Department of Gastroenterology, OMCH Endoscopy Unit, Bács-Kiskun County Hospital, Kecskemét, Hungary.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Madácsy', 'Affiliation': 'Endoscopy Unit, Endo-Kapszula Health Centre, Székesfehérvár, Hungary.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2020.1786850']
1436,32674351,The Use of Different Modes of Post-Activation Potentiation (PAP) for Enhancing Speed of the Slide-Step in Basketball Players.,"Background : This study aimed to determine whether 5% of body mass-resisted or assisted conditioning activity (CA) can enhance 5 m slide-step movement performance.  Methods : Sixteen division I basketball players participated in this study (23.6 ± 4.4 years; 86.3 ± 5.9 kg; 192.3 ± 6.2 cm; training experience 6.7 ± 2.6 years). The experiment was performed following a randomized crossover design, where each participant performed two different exercise protocols-assisted and resisted CA each consisting of four sets of 10 m slide-step movement with 5% of body mass external load and 1 min rest intervals between. To assess the differences between baseline and post-assisted, as well as post-resisted CA, the participants performed a 2 × 5 m slide-step movement 6 min after each CA protocol. The differences in time between baseline, post-assisted and post-resisted CA were examined using repeated-measures ANOVA.  Results : ANOVA indicated a statistically significant difference between baseline and post-assisted postactivation performance enhancement (PAPE) ( p  = 0.011). There were no significant intragroup differences between baseline and post-resisted CA ( p  = 0.230).  Conclusion : Findings of the study show that a light load assisted CA (5% of body mass) effectively elicits a potentiation response among basketball players.",2020,There were no significant intragroup differences between baseline and post-resisted CA ( p  = 0.230).  ,"['Sixteen division I basketball players participated in this study (23.6 ± 4.4 years; 86.3 ± 5.9 kg; 192.3 ± 6.2 cm; training experience 6.7 ± 2.6 years', 'Basketball Players']","[' ', 'body mass-resisted or assisted conditioning activity (CA', 'Different Modes of Post-Activation Potentiation (PAP', 'light load assisted CA']",['postactivation performance enhancement (PAPE'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]",,0.0797312,There were no significant intragroup differences between baseline and post-resisted CA ( p  = 0.230).  ,"[{'ForeName': 'Mariola', 'Initials': 'M', 'LastName': 'Gepfert', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Golas', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Zajac', 'Affiliation': 'Human Performance Laboratory, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, The Jerzy Kukuczka Academy of Physical Education in Katowice, Mikolowska 72a, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17145057']
1437,32674392,Benefits and Costs of a Community-Led Total Sanitation Intervention in Rural Ethiopia-A Trial-Based ex post Economic Evaluation.,"We estimated the costs and benefits of a community-led total sanitation (CLTS) intervention using the empirical results from a cluster-randomized controlled trial in rural Ethiopia. We modelled benefits and costs of the intervention over 10 years, as compared to an existing local government program. Health benefits were estimated as the value of averted mortality due to diarrheal disease and the cost of illness arising from averted diarrheal morbidity. We also estimated the value of time savings from avoided open defecation and use of neighbours' latrines. Intervention delivery costs were estimated top-down based on financial records, while recurrent costs were estimated bottom-up from trial data. We explored methodological and parameter uncertainty using one-way and probabilistic sensitivity analyses. Avoided mortality accounted for 58% of total benefits, followed by time savings from increased access to household latrines. The base case benefit-cost ratio was 3.7 (95% CI: 1.9-5.4) and the net present value was Int'l $1,193,786 (95% CI: 406,017-1,977,960). The sources of the largest uncertainty in one-way sensitivity analyses were the effect of the CLTS intervention and the assumed lifespan of an improved latrine. Our results suggest that CLTS interventions can yield favourable economic returns, particularly if follow-up after the triggering is implemented intensively and uptake of improved latrines is achieved (as opposed to unimproved).",2020,"The base case benefit-cost ratio was 3.7 (95% CI: 1.9-5.4) and the net present value was Int'l $1,193,786 (95% CI: 406,017-1,977,960).",['rural Ethiopia'],"['Community-Led Total Sanitation Intervention', 'community-led total sanitation (CLTS) intervention', 'CLTS interventions']",['Avoided mortality'],"[{'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0617726,"The base case benefit-cost ratio was 3.7 (95% CI: 1.9-5.4) and the net present value was Int'l $1,193,786 (95% CI: 406,017-1,977,960).","[{'ForeName': 'Seungman', 'Initials': 'S', 'LastName': 'Cha', 'Affiliation': 'Faculty of Infectious and Tropical Disease, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK.'}, {'ForeName': 'Sunghoon', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Good Neighbors International, Mozambique, Maputo, Mozambique.'}, {'ForeName': 'Dawit Belew', 'Initials': 'DB', 'LastName': 'Bizuneh', 'Affiliation': 'Independent Consultant, Addis Ababa, Ethiopia.'}, {'ForeName': 'Tadesse', 'Initials': 'T', 'LastName': 'Abera', 'Affiliation': 'Public Health Institute, Addis Ababa, Ethiopia.'}, {'ForeName': 'Young-Ah', 'Initials': 'YA', 'LastName': 'Doh', 'Affiliation': 'Korea International Cooperation Agency, Seongnam 13449, Korea.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Seong', 'Affiliation': 'Korea International Cooperation Agency, Seongnam 13449, Korea.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ross', 'Affiliation': 'Faculty of Infectious and Tropical Disease, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17145068']
1438,32679238,Self-reported Snoring Patterns Predict Stroke Events in High-Risk Patients With OSA: Post Hoc Analyses of the SAVE Study.,"BACKGROUND


The relation of snoring to risks of stroke and other major cardiovascular (CV) events is uncertain.
RESEARCH QUESTION


We aimed to determine associations of snoring patterns and major CV events in relation to OSA among participants of the international Sleep Apnea cardiovascular Endpoints (SAVE) trial.
STUDY DESIGN AND METHODS


Post hoc analyses of the SAVE trial, which involved 2,687 patients with coexisting moderate-to-severe OSA and established coronary or cerebral CV disease, who were randomly allocated to CPAP treatment plus usual care or usual care alone, and followed-up for a median 3.5 years. Associations of self-reported snoring patterns (frequency and loudness) and breathing pauses collected on the Berlin questionnaire at baseline and multiple times during follow-up, and adjudicated composites of CV outcomes (primary, CV death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina, heart failure, or transient ischemic attack; and separately of cardiac and cerebral events), were evaluated in time-dependent Cox proportional hazards models adjusted for various confounders including the apnea-hypopnea index.
RESULTS


Increase (per category) of snoring frequency (adjusted hazard ratio [HR], 1.10; 95% CI, 1.02-1.20; P = .015), loudness (HR, 1.16; 95% CI, 1.06-1.27; P = .001), and breathing pauses (HR, 1.16; 95% CI, 1.08-1.25; P < .001) at any time point during follow-up were each associated with the primary composite CV outcome. These associations were driven by significant associations for cerebral rather than cardiac events, and positive interactions between the three snoring patterns for cerebral events. There was no significant interaction between CPAP treatment and snoring variables for cerebral events.
INTERPRETATION


Snoring in patients with OSA with established CV disease is associated with greater risks of cerebral but not cardiac events, independent of CPAP treatment and frequency of apnea and hypopnea events.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT00738179; URL: www.clinicaltrials.gov.",2020,"These associations were driven by significant associations for cerebral rather than cardiac events, and positive interactions between the three snoring patterns for cerebral events.","['high-risk patients with obstructive sleep apnea', '2687 patients with co-existing moderate-severe OSA and established coronary or cerebral CV disease', 'OSA patients with established CV disease']","['Self-reported snoring patterns', 'continuous positive airway pressure (CPAP) treatment plus usual care or usual care alone']","['breathing pauses', 'CV outcomes (primary, CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina, heart failure, or transient ischemic attack; and separately of cardiac and cerebral events', 'snoring patterns (frequency and loudness) and breathing pauses', 'snoring frequency (adjusted hazard ratio [HR', 'apnea-hypopnea index']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",2687.0,0.0769172,"These associations were driven by significant associations for cerebral rather than cardiac events, and positive interactions between the three snoring patterns for cerebral events.","[{'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Xinqiao Hospital, Third Military Medical University, Chongqing, China; Department of Cardiology, People's Liberation Army General Hospital, Beijing, China; The George Institute for Global Health, Faculty of Medicine, University of New South Wales, NSW, Australia.""}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'The Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, NSW, Australia; Pharmacology Discipline, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Loffler', 'Affiliation': 'The Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, NSW, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""The Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Woodman', 'Affiliation': 'Centre for Biostatistics & Epidemiology, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, NSW, Australia; The George Institute China at Peking University Health Science Center, Beijing, China; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, NSW, Australia; Heart Health Research Center, Beijing, China; Universidad del Desarrollo, School of Medicine-Clínica Alemana, ICIM, Center for Clinical Studies, Santiago, Chile. Electronic address: canderson@georgeinstitute.org.au.'}]",Chest,['10.1016/j.chest.2020.05.615']
1439,32618538,Influence of pre-schooler and parent nutrition education on carotenoid levels of Mexican-heritage children.,"OBJECTIVE


To determine the mediating effect of direct preschool and parent nutrition education on changes in skin carotenoids scores over 2 years in children of Mexican heritage.
DESIGN


In a quasi-experimental, community-based study, two school districts were randomly assigned to either a comparison group (parent workshops unrelated to nutrition) or a childhood obesity prevention intervention group which included nutrition education at family nights for parents and at school for children. Changes in skin carotenoid intensity scores (diffCAROT, year 2015 minus 2013) were measured in children as a proxy for fruit and vegetable consumption using Resonance Raman Spectroscopy.
SETTING


Two rural, low-income, school districts from a county in California's Central Valley.
PARTICIPANTS


316 Mexican heritage families with children aged 3-8 years.
RESULTS


Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001). Parent attendance at nutrition education classes partially mediated the intervention effect on diffCAROT (P = 0·02). Controlling for child's age and other covariates, participation in preschool during the study had a significant positive effect on diffCAROT among intervention children compared with controls (P < 0·03), whereas no significant difference by group was observed among those not enrolled in preschool or already enrolled in elementary school.
CONCLUSIONS


Programmes that combine direct parent and preschool nutrition education may be effective in low-income Mexican heritage families to improve children's intake of fruit and vegetables.",2020,"RESULTS


Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001).","['316 Mexican heritage families with children aged 3-8 years', ""Two rural, low-income, school districts from a county in California's Central Valley"", 'In a quasi-experimental, community-based study, two school districts', 'children of Mexican heritage', 'Mexican-heritage children']","['direct preschool and parent nutrition education', 'pre-schooler and parent nutrition education', 'comparison group (parent workshops unrelated to nutrition) or a childhood obesity prevention intervention group which included nutrition education at family nights for parents and at school for children']","['skin carotenoid scores', 'skin carotenoid intensity scores', 'skin carotenoids scores']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.0238306,"RESULTS


Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001).","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'University of California Cooperative Extension, Yolo County, Woodland, CA95695, USA.'}, {'ForeName': 'Lucia L', 'Initials': 'LL', 'LastName': 'Kaiser', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Rosa D', 'Initials': 'RD', 'LastName': 'Manzo', 'Affiliation': 'Health Sciences Research Institute, University of California, Merced, CA, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Aguilera', 'Affiliation': 'Department of Public Health, University of California, Merced, CA, USA.'}, {'ForeName': 'L Karina', 'Initials': 'LK', 'LastName': 'Diaz Rios', 'Affiliation': 'Division of Agriculture and Natural Resources, University of California, Merced, CA, USA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Macias', 'Affiliation': 'University of California Cooperative Extension, Fresno County, CA, USA.'}]",Public health nutrition,['10.1017/S1368980019004579']
1440,32633244,"Large study (283 women) on the effectiveness of Manosar®: 2 g of d-mannose + 140 mg of proanthocyanidins (PAC), of prolonged release.","OBJECTIVE


To compare the efficacy and safety in the prophylasis of urinary tract infections (UTIs) with a food supplement that contains D-mannose like active ingredient (Manosar®), in comparison to another preparation in which the active ingredient are the proanthocyanidins (PAC), both of them, in prolonged released, after, they was administered for 24 weeks.
METHODS


A multicenter, randomized and double blind experimental study was carried out. 283 women with a history of recurrent UTIs without evidence of complication were included. They were randomized 1: 1 in two groups. In one group, 1 oral sachet of Manosar® a day was administered, and in the other group 1 oral sachet of a compound of 240 mg of continuous-release PAC. Prior to inclusion in the study, the episode of UTI was confirmed at least by the clinical symptoms and positivity of the Combur test.
RESULTS


Valid data were obtained from 184 patients with an average age of 49.5 years: 90 received Manosar® and 94 isolated PAC. A total of 72 patients suffered an UTI due to E.coli: 25 patients in the arm with Manosar® versus 47 patients in the isolated PAC group, this difference being statistically significant (p=0.002). The free time of new UTI recurrences was 98.6 days in the group treated with Manosar® and 84.6 days in the group with isolated PAC.
CONCLUSION


The oral taking of a daily sachet of Manosar® is effective and safe in preventing recurrent UTIs in women, being superior to the oral taking of isolated PAC.",2020,"The oral taking of a daily sachet of Manosar® is effective and safe in preventing recurrent UTIs in women, being superior to the oral taking of isolated PAC.","['184 patients with an average age of 49.5 years: 90 received Manosar® and 94 isolated PAC', '283 women with a history of recurrent UTIs without evidence of complication were included', '72 patients suffered an UTI due to E.coli: 25 patients in the arm with Manosar® versus 47 patients in the isolated PAC group', 'Large study (283 women']","['Manosar®', 'food supplement that contains D-mannose like active ingredient (Manosar®', 'Manosar®: 2 g of d-mannose + 140 mg of proanthocyanidins (PAC']","['efficacy and safety', 'free time of new UTI recurrences']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0072018', 'cui_str': 'Proanthocyanidin'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3532611', 'cui_str': 'History of recurrent urinary tract infection'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0024742', 'cui_str': 'Mannose'}, {'cui': 'C1292749', 'cui_str': 'Has active ingredient'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0072018', 'cui_str': 'Proanthocyanidin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",283.0,0.0578281,"The oral taking of a daily sachet of Manosar® is effective and safe in preventing recurrent UTIs in women, being superior to the oral taking of isolated PAC.","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Salinas-Casado', 'Affiliation': 'Servicio de Urología. Hospital Clínico San Carlos. Madrid. España.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Méndez-Rubio', 'Affiliation': 'Servicio de Urología. Hospital Universitario Sanitas La Moraleja. Madrid. España.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Esteban-Fuertes', 'Affiliation': 'Servicio de Urología. Hospital Nacional de Parapléjicos de Toledo. Toledo. España.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gómez-Rodríguez', 'Affiliation': 'Servicio de Urología. Complejo Hospitalario de Toledo. Toledo. España.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vírseda-Chamorro', 'Affiliation': 'Servicio de Urología. Hospital Nacional de Parapléjicos de Toledo. Toledo. España.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Luján-Galán', 'Affiliation': 'Servicio de Urología. Hospital Universitario Infanta Cristina. Parla. Madrid. España.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Iglesias-García', 'Affiliation': 'Clinical Partner & Innovation, S.L. Madrid. España.'}, {'ForeName': 'Grupo', 'Initials': 'G', 'LastName': 'Rituman', 'Affiliation': 'Autores del Grupo Rituman.'}]",Archivos espanoles de urologia,[]
1441,32634642,Evaluation of the perioperative effects of dexmedetomidine on tympanoplasty operations.,"PURPOSE


This randomized double-blind study aimed to evaluate the effects of dexmedetomidine on hemodynamic parameters and the quality of surgery and recovery criteria in tympanoplasty operations.
MATERIALS AND METHODS


A total of 75 patients 18-55 years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II, were randomly divided into three groups. Group 1 included patients receiving remifentanil alone, Group 2 included patients receiving dexmedetomidine + remifentanil and Group 3 included patients receiving dexmedetomidine + ½ remifentanil. Anesthesia was induced with propofol and cisatracurium. For maintenance of anesthesia, a mixture of 2-2.5% sevoflurane, 40-60% oxygen/air was used. The groups were compared in terms of hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects.
RESULTS


Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3. Surgical field satisfaction was higher in Group 2 and Group 3 than Group 1. Spontaneous breathing, eye opening and verbal cooperation times were shorter in Group 3 compared to Group 2. Eye opening and verbal cooperation times were longer in Group 2 compared to Group 1. The 30-minute modified Aldrete scores was higher in Group 3 compared to Group 1. There was no difference between the groups in terms of postoperative pain and adverse effects.
CONCLUSION


The use of dexmedetomidine during tympanoplasty operations may provide better hemodynamic control and surgical view, may provide faster recovery and may reduce remifentanil consumption.",2020,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","['75 patients 18-55\xa0years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II']","['dexmedetomidine + ½ remifentanil', 'remifentanil alone', 'propofol and cisatracurium', 'sevoflurane', 'dexmedetomidine', 'dexmedetomidine + remifentanil']","['Eye opening and verbal cooperation times', 'Mean arterial pressure and heart rate values', 'Surgical field satisfaction', 'Spontaneous breathing, eye opening and verbal cooperation times', 'postoperative pain and adverse effects', 'hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects', 'tympanoplasty operations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",75.0,0.0542959,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","[{'ForeName': 'Muge', 'Initials': 'M', 'LastName': 'Kosucu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey. Electronic address: mugekk73@hotmail.com.'}, {'ForeName': 'Ersagun', 'Initials': 'E', 'LastName': 'Tugcugil', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Bengu', 'Initials': 'B', 'LastName': 'Cobanoglu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Otorhinolaryngology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Neurosurgery, 61080 Trabzon, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102619']
1442,32645164,An Evaluation of Baseline Kidney Function in the REPRIEVE Trial of Pitavastatin in Human Immunodeficiency Virus.,"BACKGROUND


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


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


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


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


NCT02344290.",2020,"In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate.","['7770 participants enrolled, the median age was 50 years, 31% were female (natal sex), 43% black or African American and 15% Asian, the', 'Human Immunodeficiency Virus', 'persons living with human immunodeficiency virus (PWH']","['tenofovir disoproxil fumarate exposure', 'statin therapy', 'eGFR', 'tenofovir disoproxil fumarate', 'Pitavastatin']","['median CKD-EPI eGFR', 'median CD4 cell count', 'median body mass index', 'glomerular filtration rate (eGFR) with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification of Diet in Renal Disease, and Cockcroft-Gault equations', 'cardiovascular events']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",7770.0,0.0804019,"In the adjusted model, factors associated with eGFR <90 mL/min/1.73 m2 included white race, older age, higher body mass index, high-income region of enrollment, hypertension, and tenofovir disoproxil fumarate.","[{'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Overton', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen V', 'Initials': 'KV', 'LastName': 'Fitch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Khuanchai', 'Initials': 'K', 'LastName': 'Supparatpinyo', 'Affiliation': 'HIV Treatment Clinical Research Site, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Mosepele', 'Initials': 'M', 'LastName': 'Mosepele', 'Affiliation': 'University of Botswana and Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Lerato', 'Initials': 'L', 'LastName': 'Mohapi', 'Affiliation': 'Soweto Clinical Research Site, Chris Hani Baragwanath Hospital, Johannesburg, Gauteng, South Africa.'}, {'ForeName': 'Sandra Wagner', 'Initials': 'SW', 'LastName': 'Cardoso', 'Affiliation': 'Fiocruz Therapeutic and Prevention HIV/AIDS Clinical Trials Unit, Rio de Janeiro, Brazil.'}, {'ForeName': 'Sandesh', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India.'}, {'ForeName': 'Marcus V G', 'Initials': 'MVG', 'LastName': 'de Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Doutor Heitor Viera Dourado, Manaus, Amazonas, Brazil.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'McComsey', 'Affiliation': 'Division of Pediatric Infectious Diseases and Rheumatology, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ribaudo', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Wyatt', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa222']
1443,32649708,Feasibility and acceptability of a milk and resistance exercise intervention to improve muscle function in community-dwelling older adults (MIlkMAN): Pilot study.,"BACKGROUND


Dietary protein supplementation combined with resistance exercise (RE) may counteract declines in muscle strength, mass, and function (sarcopenia), but the role of whole foods rich in protein, such as milk, is less well understood. In the MIlkMAN study, we aimed to examine the feasibility and acceptability of milk+RE as an intervention for muscle function in community-dwelling older adults, and provide exploratory pilot data for future substantive research in population at risk of sarcopenia.
METHODS


In a parallel groups design, 30 older adults (71.7±3.6 years; 12 women) were randomised into three groups: WM (whole milk 3.6% fat)+RE, SM (skimmed milk 0.3% fat)+RE, and C (isocaloric carbohydrate drink)+RE. RE was performed twice-weekly over 6 weeks in a community gym, followed by the consumption of 500 ml of milk (~20 g protein) or carbohydrate drink immediately after exercise and a further 500 ml at home within the following 4-5 hours. The feasibility and acceptability of the study was determined by calculating recruitment and attendance rates, compliance with the intervention, rating participants' experiences, and recording adverse health events.
RESULTS


The response rate was 49% (out of 400 invitations sent), and the recruitment rate was 73.2% (30 participants recruited out of 41 screened for eligibility). Twenty-nine participants completed the intervention-an attendance rate of 97.1%; 89.7% rated their experience as 'excellent'/very good'. Compliance with taking the drinks was 97.1% (WM), 98.3% (SM), and 95.0% (C); 93.1% rated their drink intake as 'easy'/'very easy' with no adverse effects. Collection of exploratory pilot data to inform future trials was successful. Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
CONCLUSIONS


This community-based milk+RE intervention was feasible and acceptable to older adults. The study successfully collected pilot data for future substantive research.",2020,"Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
","['30 older adults (71.7±3.6 years; 12 women', 'older adults', 'community-dwelling older adults', '20', 'community-dwelling older adults (MIlkMAN']","['milk and resistance exercise intervention', 'milk+RE', 'carbohydrate drink', 'WM (whole milk 3.6% fat)+RE, SM (skimmed milk 0.3% fat)+RE, and C (isocaloric carbohydrate drink)+RE', 'Dietary protein supplementation combined with resistance exercise (RE', 'milk+RE intervention']","['attendance rate', 'muscle function', 'Mean change in grip strength, 5-chair rises, and gait speed', ""calculating recruitment and attendance rates, compliance with the intervention, rating participants' experiences, and recording adverse health events"", 'response rate', 'Feasibility and acceptability']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0402554', 'cui_str': 'Milkman'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0452717', 'cui_str': 'Whole milk'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",30.0,0.0398701,"Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
","[{'ForeName': 'Antoneta', 'Initials': 'A', 'LastName': 'Granic', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hurst', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Lorelle', 'Initials': 'L', 'LastName': 'Dismore', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, Research and Development, North Tyneside General Hospital, North Shields, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Stevenson', 'Affiliation': 'Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Avan A', 'Initials': 'AA', 'LastName': 'Sayer', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Aspray', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0235952']
1444,32652064,Validation of an enhanced recovery after surgery protocol in gynecologic surgery: an Italian randomized study.,"BACKGROUND


The enhanced recovery after surgery concept, which was introduced 20 years ago, is based on a multimodal approach to improve the functional rehabilitation of patients after surgery.
OBJECTIVE


This study aimed to validate an enhanced recovery after surgery protocol in gynecologic surgery for both benign and malignant diseases (endometrial cancer and advanced ovarian cancer) and to measure the adherence to the enhanced recovery after surgery protocol items in a randomized trial setting.
STUDY DESIGN


In this trial (NCT03347409), we randomly assigned patients to undergo standard perioperative care or enhanced recovery after surgery protocol. The primary outcome is a shorter length of stay in favor of the enhanced recovery after surgery protocol. Secondary outcomes include measurement of adherence to the enhanced recovery after surgery protocol items: comparison of postoperative pain, vomiting, and nausea; anesthesiologic and surgical complications up to 30 days after surgery; rate of readmissions; the time to event in hours for bowel movements, flatus, drinking, hunger, eating, and walking; and the quality of recovery using a validated questionnaire (QoR-15). Finally, we explored the length of stay in the prespecified subgroups at randomization, based on the type of surgical access and gynecologic disease.
RESULTS


A total of 168 women were available for analysis: 85 women (50.6%) were assigned to the standard perioperative care group, and 83 women (49.4%) were assigned to the enhanced recovery after surgery protocol group. The 2 groups were similar for age, body mass index, comorbidities, anesthesiological risk, smoking habits, surgical access, and complexity of surgical procedures. Seventy-two patients (42.9%) underwent surgery for benign disease, 48 (28.6%) for endometrial cancer, and 48 (28.6%) for ovarian cancer. Women in the enhanced recovery after surgery protocol group had a shorter length of stay (median: 2 [interquartile range, 2-3] vs 4 [interquartile range, 4-7] days; P<.001). A decreased rate of postoperative complications was noted for the enhanced recovery after surgery protocol group, as well as an earlier time to occur for all the events. Mean adherence to protocol items was 84.8% (95% confidence interval, 79.7-89.8), and we registered a better satisfaction in the enhanced recovery after surgery protocol group. The shortening of the length of stay was confirmed also in the prespecified subgroup analysis.
CONCLUSION


Application of the enhanced recovery after surgery protocol in gynecologic surgery translated to a shorter length of stay regardless of surgical access and type of gynecologic disease. Adherence to the enhanced recovery after surgery protocol items in the setting of a randomized trial was high.",2020,"The two groups were similar for age, BMI, comorbidities, anesthesiological risk, smoking habits, surgical access and complexity of surgical procedures.","['gynecological surgery', 'gynecological surgery both for benign and malignant disease (endometrial cancer and advanced ovarian cancer', 'A total of 168 women were available for analysis, of them 85 (50.6%) underwent standard perioperative care while 83 (49.4%) were assigned to']","['ERAS protocol', 'standard perioperative care or ERAS protocol', 'ERAS', 'surgery (ERAS) protocol']","['shortening of the length of stay', 'Mean adherence to protocol items', 'shorter length of stay in favor of ERAS', 'shorter length of stay, regardless of surgical access and type of gynecological disease', 'measurement of adherence to ERAS items, comparison of postoperative pain, vomiting and nausea, anesthesiological and surgical complications up to thirty days after surgery, rate of readmissions, the time-to-event in hours for bowel movements, flatus, drink, hunger, eating and walking and lastly the quality of recovery using a validated questionnaire (QoR 15', 'shorter length of stay', 'rate of postoperative complications']","[{'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0017411', 'cui_str': 'Disorder of female genital organs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",168.0,0.160542,"The two groups were similar for age, BMI, comorbidities, anesthesiological risk, smoking habits, surgical access and complexity of surgical procedures.","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy. Electronic address: f.ferrari.obgyn@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Forte', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Sbalzer', 'Affiliation': 'Department of Anesthesia, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Zizioli', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mauri', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Maggi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Sartori', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Odicino', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.07.003']
1445,32658264,Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial.,"CONTEXT


Abaloparatide is a US Food and Drug Administration-approved parathyroid hormone-related peptide analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
OBJECTIVES


We assessed the cardiovascular safety profile of abaloparatide.
DESIGN


Review of heart rate (HR), blood pressure (BP), and cardiovascular-related adverse events (AEs), including major adverse cardiovascular events (MACEs) and heart failure (HF) from: (a) ACTIVE (NCT01343004), a phase 3 trial that randomized 2463 postmenopausal women with osteoporosis to abaloparatide, teriparatide, or placebo for 18 months; (b) ACTIVExtend (NCT01657162), where participants from the abaloparatide and placebo arms received alendronate for 2 years; and (c) a pharmacology study in 55 healthy adults.
RESULTS


Abaloparatide and teriparatide transiently increased HR relative to placebo. Following first dose, mean (standard deviation [SD]) HR change from pretreatment to 1 hour posttreatment was 7.9 (8.5) beats per minute (bpm) for abaloparatide, 5.3 (7.5) for teriparatide, and 1.2 (7.1) for placebo. A similar pattern was observed over subsequent visits. In healthy volunteers, HR increase resolved within 4 hours. The corresponding change in mean supine systolic and diastolic BP 1 hour posttreatment was -2.7/-3.6 mmHg (abaloparatide), -2.0/-3.6 (teriparatide), and -1.5/-2.3 (placebo). The percentage of participants with serious cardiac AEs was similar among groups (0.9%-1.0%). In a post hoc analysis, time to first incidence of MACE + HF was longer with abaloparatide (P = 0.02 vs placebo) and teriparatide (P = 0.04 vs placebo).
CONCLUSIONS


Abaloparatide was associated with transient increases in HR and small decreases in BP in postmenopausal women with osteoporosis, with no increase in risk of serious cardiac AEs, MACE, or HF.",2020,"Abaloparatide is an FDA-approved PTHrp analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
","['postmenopausal women at high risk of fracture', 'Postmenopausal Women with Osteoporosis', 'postmenopausal women with osteoporosis', 'healthy volunteers', 'for 18 months', '2463 postmenopausal women with osteoporosis to abaloparatide', '55 healthy adults']","['teriparatide', 'teriparatide, or placebo', 'Abaloparatide', 'alendronate', 'abaloparatide and placebo', 'placebo']","['heart rate (HR), blood pressure (BP), and cardiovascular-related adverse events (AEs), including major adverse cardiovascular events (MACE) and heart failure (HF', 'mean (SD) HR change', 'risk of serious cardiac AEs, MACE, or HF', 'mean supine systolic and diastolic BP', 'percentage of participants with serious cardiac AEs', 'Cardiovascular Safety', 'HR relative']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",2463.0,0.501999,"Abaloparatide is an FDA-approved PTHrp analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
","[{'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, Columbia University, New York, New York.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Diabetic Cardiovascular Disease Center and Department of Medicine, Washington University, St Louis, Missouri.'}, {'ForeName': 'Dwight A', 'Initials': 'DA', 'LastName': 'Towler', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Mitlak', 'Affiliation': 'Clinical Development, Radius Health, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, Radius Health, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Cummings', 'Affiliation': 'San Francisco Coordinating Center, Sutter Health, California; University of California, San Francisco, California.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa450']
1446,32658308,Fatty acid sentinels as covalently bound randomization standards for triacylglycerol (TAG) quantitative analysis.,"RATIONALE


Quantitative analysis of triacylglycerols (TAG) is impeded by a lack of standards and the huge number of potential TAG molecular species that may be present due to the combinatorial nature of glycerolipids. Randomization of acyl groups yields TAG mixtures with profiles predictable from fatty acid profiles; however, their use as calibration mixtures has been limited.
METHODS


We introduce here the principle of fatty acid isotopic sentinels that are quantitatively added prior to randomization to enable verification that randomization is complete, and that can be used as internal standards. A mixture of two isotopically labeled fatty acid methyl esters (FAME) is prepared at a ratio of 2:1 and the exact ratio is carefully measured by gas chromatography flame ionization detection (GC-FID) and randomized covalently into the acyl groups of TAG mixtures.
RESULTS


Reaction with catalytic amounts of NaOCH 3  yields complete randomization, such that the product FAME and TAG have the same fatty acid profile. TAG mixture analysis reveals that the isotopic sentinels have been covalently incorporated into the TAG molecular species at <1% deviation from the expected proportions, thus verifying randomization within experimental error.
CONCLUSIONS


The sentinel principle demonstrated here as covalently incorporated internal standards verifies that randomization chemistry went to completion. It applies in general to use of combinatorial chemistry for quantitative standards.",2020,"RESULTS


Reaction with catalytic amounts of NaOCH 3  yields complete randomization, such that the product FAME and TAG have the same fatty acid profile.",[],['A mixture of two isotopically labeled fatty acid methyl esters (FAME'],[],[],"[{'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0014898', 'cui_str': 'Ester'}]",[],3.0,0.0577684,"RESULTS


Reaction with catalytic amounts of NaOCH 3  yields complete randomization, such that the product FAME and TAG have the same fatty acid profile.","[{'ForeName': 'Dong Hao', 'Initials': 'DH', 'LastName': 'Wang', 'Affiliation': 'Dell Pediatric Research Institute, Departments of Pediatrics, Chemistry, and Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Dell Pediatric Research Institute, Departments of Pediatrics, Chemistry, and Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, USA.'}, {'ForeName': 'Secilia', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Dell Pediatric Research Institute, Departments of Pediatrics, Chemistry, and Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, USA.'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Tobias', 'Affiliation': 'Dell Pediatric Research Institute, Departments of Pediatrics, Chemistry, and Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, USA.'}, {'ForeName': 'J Thomas', 'Initials': 'JT', 'LastName': 'Brenna', 'Affiliation': 'Dell Pediatric Research Institute, Departments of Pediatrics, Chemistry, and Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, USA.'}]",Rapid communications in mass spectrometry : RCM,['10.1002/rcm.8891']
1447,32665479,A Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity in Type 2 Diabetes: The BEHOLD-8 Controlled Clinical Trial.,"OBJECTIVE


Physical activity is associated with superior health outcomes in patients with type 2 diabetes (T2D), but most T2D patients do not follow physical activity recommendations. The objective of this study was to assess the feasibility and impact of a novel combined positive psychology-motivational interviewing (PP-MI) intervention to promote physical activity in T2D.
METHODS


This controlled clinical trial compared an 8-week, phone-delivered PP-MI intervention to an attention-matched MI-enhanced behavioral counseling condition among 60 participants with T2D and suboptimal moderate to vigorous physical activity (MVPA; <150 min/wk). The primary study outcome was feasibility (proportion of sessions completed) and acceptability (0-10 ease and utility ratings of each session). Secondary outcomes were between-group differences in changes in positive affect (main psychological outcome) and accelerometer-measured physical activity (MVPA and steps per day), using mixed-effects regression models, at 8 and 16 weeks.
RESULTS


Ninety-two percent of PP-MI sessions were completed, and mean participant ratings of ease/utility were 8.5 to 8.8/10, surpassing a priori benchmarks for feasibility and acceptability. PP-MI participants had small-medium effect size (ES) difference improvements in positive affect compared with MI (8 weeks: estimated mean difference [EMD] = 3.07 [SE = 1.41], p = .029, ES = 0.44; 16 weeks: EMD = 2.92 [SE = 1.73], p = .092, ES = 0.42). PP-MI participants also had greater improvements in MVPA (8 weeks: EMD = 13.05 min/d [SE = 5.00], p = .009, ES = 1.24; 16 weeks: EMD = 7.96 [SE = 4.53], p = .079, ES = 0.75), with similar improvements in steps per day.
CONCLUSIONS


The PP-MI intervention was feasible and well accepted. Next-step efficacy studies can more rigorously explore the intervention's effects on physical activity and clinical outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov Registration No. NCT03150199.",2020,"PP-MI participants also had greater improvements in MVPA (8 weeks: EMD 13.05 minutes/day [SE 5.00], p=.009, ES=1.24; 16 weeks: EMD 7.96 [SE 4.53], p=.079, ES=.75), with similar improvements in steps/day.
","['60 participants with T2D and suboptimal moderate to vigorous physical activity (MVPA; <150 minutes/week', 'Type 2 Diabetes', 'patients with type 2 diabetes (T2D']","['phone-delivered PP-MI intervention to an attention-matched MI-enhanced behavioral counseling condition', 'novel combined positive psychology-motivational interviewing (PP-MI) intervention', 'Positive Psychology-Motivational Interviewing Intervention']","['MVPA', 'feasibility (proportion of sessions completed) and acceptability (0-10 ease and utility ratings of each session', 'changes in positive affect (main psychological outcome) and accelerometer-measured physical activity (MVPA and steps/day']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0556975', 'cui_str': 'mins/week'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",60.0,0.10928,"PP-MI participants also had greater improvements in MVPA (8 weeks: EMD 13.05 minutes/day [SE 5.00], p=.009, ES=1.24; 16 weeks: EMD 7.96 [SE 4.53], p=.079, ES=.75), with similar improvements in steps/day.
","[{'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'From the Harvard Medical School (Huffman, Massey, Feig, Chung, Millstein, Brown, Healy, Wexler, Park, Celano); Departments of Psychiatry (Huffman, Golden, Massey, Feig, Chung, Millstein, Brown, Gianangelo, Park, Celano), Neurology (Healy), and Medicine (Endocrinology; Wexler), Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Golden', 'Affiliation': ''}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Massey', 'Affiliation': ''}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Feig', 'Affiliation': ''}, {'ForeName': 'Wei-Jean', 'Initials': 'WJ', 'LastName': 'Chung', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': ''}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Gianangelo', 'Affiliation': ''}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': ''}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': ''}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000840']
1448,32664244,Effect of PreAnaesThesia Computerized Health (PATCH) Assessment on Duration of Nurse-Patient Consultation and Patient Experience: A Pilot Trial.,"Preanaesthesia health assessment is gradually transitioning from paper-based, face-to-face assessment to digitized assessment, self-administered by the patient. This transition could potentially optimize the various goals of assessment, notably facilitating the efficient collection of the patient's health information. We have previously developed and validated a tablet application (PreAnaesThesia Computerized Health assessment application or ""PATCH"") for patients to conduct preanaesthesia self-assessment. In a randomized controlled trial, we sought to compare the duration of nurse-patient consultation and patient satisfaction between patients who underwent PATCH self-assessment vs. standard care nurse-led assessment. Fifty-two elective surgical patients were randomized to complete either PATCH assessment or standard care nurse-led assessment at an outpatient preoperative clinic. The duration of nurse-patient consultation was subsequently noted for all patients who also completed a satisfaction survey. The mean (SD) nurse-patient consultation times in the PATCH and standard care groups were comparable, at 11.5 (3.6) min and 12.2 (2.9) min, respectively ( p  = 0.703). Overall satisfaction scores were also comparable, at 23.9 and 27.0 respectively ( p  = 0.451) for the PATCH and standard nurse assessment groups. Favorable perceptions of PATCH among users ranged between 41.7% and 79.2%. In conclusion, PATCH self-assessment can feasibly be introduced into current practice with comparable nurse-patient consultation times and patient satisfaction.",2020,"Overall satisfaction scores were also comparable, at 23.9 and 27.0 respectively ( p  = 0.451) for the PATCH and standard nurse assessment groups.",['Fifty-two elective surgical patients'],"['PATCH self-assessment vs. standard care nurse-led assessment', 'PreAnaesThesia Computerized Health (PATCH) Assessment', 'tablet application (PreAnaesThesia Computerized Health assessment application or ""PATCH', 'PATCH assessment or standard care nurse-led assessment at an outpatient preoperative clinic']","['mean (SD) nurse-patient consultation times', 'duration of nurse-patient consultation', 'Overall satisfaction scores']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028658', 'cui_str': 'Nurse Patient Relations'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",52.0,0.0193419,"Overall satisfaction scores were also comparable, at 23.9 and 27.0 respectively ( p  = 0.451) for the PATCH and standard nurse assessment groups.","[{'ForeName': 'Tarig', 'Initials': 'T', 'LastName': 'Osman', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Lew', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Lum', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Chew', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Rajive', 'Initials': 'R', 'LastName': 'Dabas', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Ban Leong', 'Initials': 'BL', 'LastName': 'Sng', 'Affiliation': ""Department of Women's Anaesthesia, KK Women's and Children's Hospital, Singapore 229899, Singapore.""}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17144972']
1449,32669215,Effect of Puppet Show on Children's anxiety and pain levels during the circumcision operation: A randomized controlled trial.,"INTRODUCTION


Surgical procedures are the most common causes of anxiety and pain in hospitalized children. One of the most common surgical procedures for children is circumcision. Surgical procedures such as circumcision in hospitals are the most common causes of pain, fear, and anxiety in children. Therapeutic play methods as non-pharmacological applications are being developed recently for children who use analgesics in the treatment of pain and anxiety. Nurses can use the game in three areas such as a care strategy for hospitalized children during daily routine practices, surgery, and invasive or painful treatment procedures. An extensive literature review revealed that there were therapeutic game plays performed before and after the surgical procedure. Nonetheless, no therapeutic game play performed during the surgical procedure were reported. In addition, no reported study of puppet show which is one of the therapeutic game methods were found.
OBJECTIVE


The aim of this study was to investigate the effect of the puppet show demonstrated to 7-11 years old children during circumcision on the anxiety and pain level of children.
DESIGN


The study was designed as a randomized controlled experiment.
MATERIALS AND METHODS


The population of the study was the children between 7 and 11 years of old and being circumcised in the urology clinic at Research and Training Hospital in Karabük Turkey between 1 May and 1 September 2017. A total of 81 (experimental group: 40, control group: 41) children were included in the study. ""Participant Information Form"", ""Wong Baker Faces Pain Rating Scale"" and ""State-Trait Anxiety Inventory for Children"" were used as implemented in the literature.
RESULTS


The median pain score of the experimental group during and after the procedure was statistically lower than the control group. The level of anxiety during and after the procedure in the experimental group showed a statistically significant decrease compared to the pre-treatment level and the level of anxiety after the procedure showed a statistically significant decrease compared to the procedure. In the control group, while the level of anxiety during the procedure showed a statistically significant increase compared to the pre-treatment level, the level of anxiety after the procedure showed a statistically significant decrease compared to the one during the procedure.
CONCLUSION


It was concluded that the puppet show performed during the circumcision procedure was effective in reducing the pain and anxiety that developed during the circumcision and continued after the procedure.",2020,The level of anxiety during and after the procedure in the experimental group showed a statistically significant decrease compared to the pre-treatment level and the level of anxiety after the procedure showed a statistically significant decrease compared to the procedure.,"['children between 7 and 11 years of old and being circumcised in the urology clinic at Research and Training Hospital in Karabük Turkey between 1 May and 1 September 2017', 'hospitalized children during daily routine practices, surgery, and invasive or painful treatment procedures', '7-11 years old children during circumcision on the anxiety and pain level of children', 'hospitalized children', 'children who use analgesics in the treatment of pain and anxiety', 'A total of 81 (experimental group: 40, control group: 41) children were included in the study. ']",['Puppet'],"['median pain score', 'level of anxiety', ""Children's anxiety and pain levels"", 'Participant Information Form"", ""Wong Baker Faces Pain Rating Scale"" and ""State-Trait Anxiety Inventory', 'pain and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C3812395', 'cui_str': 'Urology clinic'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0034125', 'cui_str': 'Puppets'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0332306,The level of anxiety during and after the procedure in the experimental group showed a statistically significant decrease compared to the pre-treatment level and the level of anxiety after the procedure showed a statistically significant decrease compared to the procedure.,"[{'ForeName': 'Özge Karakaya', 'Initials': 'ÖK', 'LastName': 'Suzan', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Health Sciences, University of Sakarya, Esentepe Campus, 54187, Turkey. Electronic address: ozgekarakayasuzan@sakarya.edu.tr.'}, {'ForeName': 'Özlem Öztürk', 'Initials': 'ÖÖ', 'LastName': 'Şahin', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Karabuk University, Demir-Celik Kampusu, 78050, Karabuk, Turkey. Electronic address: zlemzturk@hotmail.com.'}, {'ForeName': 'Özer', 'Initials': 'Ö', 'LastName': 'Baran', 'Affiliation': 'Department of Urology, Faculty of Medical, Karabuk University, Demir-Celik Kampusu, 78050, Karabuk, Turkey. Electronic address: ozerbaran@karabuk.edu.tr.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.06.016']
1450,32676977,"A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects.","BACKGROUND


The delta opioid receptor (DOR) has been identified as a therapeutic target for migraine, with DOR agonists exhibiting low abuse potential compared with conventional µ-opioid agonists. TRV250 is a novel small molecule agonist of the DOR that is preferentially selective for G-protein signaling, with relatively little activation of the β-arrestin2 post-receptor signaling pathway. This selectivity provides reduced susceptibility to proconvulsant activity seen with non-selective DOR agonists. TRV250 significantly reduced nitroglycerin-evoked hyperalgesia in rodents, indicating a potential utility in acute migraine without the risk of seizure activity or abuse potential.
OBJECTIVE


This trial evaluated the safety, tolerability, and pharmacokinetics of ascending dose levels of TRV250 administered subcutaneously (SC) and the relative bioavailability of TRV250 administered orally compared with SC administration.
METHODS


This was a two-part, single ascending dose study. Part A included four cohorts of healthy adults (N = 38). Each cohort was dosed on three occasions (placebo and two different dose levels of TRV250, allocated in randomized order and administered by SC route). In Part B, a single cohort of nine subjects received an oral dose of either TRV250 (n = 7) or placebo (n = 2) in a fed or fasted state. Serial blood samples were obtained for pharmacokinetic determination across a 24-h post-dose period. Safety assessments included clinical laboratory measures, vital signs, 12-lead electrocardiogram (ECG), and electroencephalogram (EEG) pre- and post-dosing.
RESULTS


TRV250 was well tolerated. There were no serious adverse events (SAEs), and all AEs were mild in severity. Injection-site reactions and headache were the most common AEs. One subject was withdrawn from the study due to a TRV250-related AE of postural orthostatic tachycardia. There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects. No subject experienced abnormalities in EEGs or experienced a change from baseline in heart-rate-corrected QT interval (QTcF) > 60 ms, or an absolute QTcF interval > 480 ms at any post-dosing observation. Peak and total plasma exposure to TRV250 increased in a dose-proportional manner following 0.1-30 mg SC doses, with the mean half-life ranging from 2.39 to 3.76 h. Oral bioavailability of TRV250 ranged from 14% (fasting) to 19% (fed) relative to SC dosing, while administration with food increased the AUC but decreased the rate of absorption as reflected by a modest delay in median time to maximum concentration and a slight reduction in maximum concentration.
CONCLUSION


The findings from the first-in-human study support further evaluation of TRV250, a G-protein selective DOR agonist, in the treatment of acute migraine.",2020,"There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects.","['Part A included four cohorts of healthy adults (N\u2009=\u200938', 'Healthy Subjects']","['occasions (placebo', 'Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist', 'TRV250 administered subcutaneously (SC', 'TRV250', 'placebo']","['clinical laboratory measures, vital signs, 12-lead electrocardiogram (ECG), and electroencephalogram (EEG) pre- and post-dosing', 'absolute QTcF interval\u2009', 'tolerated', 'rate of absorption', 'safety, tolerability, and pharmacokinetics', 'Peak and total plasma exposure to TRV250', 'physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs', 'serious adverse events (SAEs', 'nitroglycerin-evoked hyperalgesia', 'heart-rate-corrected QT interval (QTcF)\u2009']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0008000', 'cui_str': 'Clinical Chemistry'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.101361,"There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena, Inc., 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA. mfossler@trevena.com.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Schmith', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Greene', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lohmer', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kramer', 'Affiliation': 'Scientific Operations and Alliance Management, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Arscott', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'James', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}]",CNS drugs,['10.1007/s40263-020-00738-0']
1451,32673356,Comparing feasibility of low-tube-voltage protocol with low-iodine-concentration contrast and high-tube-voltage protocol with high-iodine-concentration contrast in coronary computed tomography angiography.,"BACKGROUND


To investigate the feasibility of a low tube voltage (80 kVp) protocol with low concentration contrast media (CM) (iodixanol 320 mgl/ml) as compared with a high tube voltage (100 kVp) protocol with high concentration CM (iomeprol 400 mgl/ml) in coronary CT angiography (CCTA) for patients with body mass index less than 30.
MATERIALS AND METHODS


A total of 93 patients were randomly assigned into three groups and underwent CCTA as follows: Group A) 100 kVp, 100-350 mAs, 400 mgl/ml CM at 4ml/s, and reconstructed with filtered back projection; Group B and C) 80 kVp, 100-450 mAs, 320 mgl/ml CM at 4 ml/s and 5 ml/s, respectively and reconstructed with iterative reconstruction. Objective and subjective image quality (IQ) was analyzed.
RESULTS


The image noise, intravascular attenuation, signal-to-noise ratio and contrast-to-noise ratio of major coronary arteries did not differ significantly among three groups. Subjective IQ analyses on vascular attenuation and image noise did not differ significantly, either (all of p > 0.05). Qualitative IQ of Group B and C was non-inferior to that of Group A. Substantial reduction of radiation exposure was achieved in group B (2.60 ± 0.48 mSv) and C (2.72 ± 0.54 mSv), compared with group A (3.58 ± 0.67 mSv) (p < 0.05).
CONCLUSION


CCTA at 80 kVp with 320 mgl/ml CM and iterative reconstruction is feasible, achieving radiation dose reduction, while preserving IQ.",2020,"Subjective IQ analyses on vascular attenuation and image noise did not differ significantly, either (all of p > 0.05).","['patients with body mass index less than 30', 'A total of 93 patients']","['low tube voltage (80 kVp) protocol with low concentration contrast media (CM) (iodixanol 320 mgl/ml) as compared with a high tube voltage (100 kVp) protocol with high concentration CM (iomeprol 400 mgl/ml) in coronary CT angiography (CCTA', 'CCTA', 'low-tube-voltage protocol with low-iodine-concentration contrast and high-tube-voltage protocol with high-iodine-concentration contrast in coronary computed tomography angiography']","['radiation exposure', 'Objective and subjective image quality (IQ', 'image noise, intravascular attenuation, signal-to-noise ratio and contrast-to-noise ratio of major coronary arteries', 'vascular attenuation and image noise']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C2350056', 'cui_str': 'iodixanol-320'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0635652', 'cui_str': 'iomeprol 400'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",93.0,0.0341413,"Subjective IQ analyses on vascular attenuation and image noise did not differ significantly, either (all of p > 0.05).","[{'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Cha', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Mok', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Ran', 'Initials': 'TR', 'LastName': 'Ahn', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yeon Hyeon', 'Initials': 'YH', 'LastName': 'Choe', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0236108']
1452,32679537,Blood pressure postpartum (BP 2 ) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy.,"OBJECTIVES


Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP 2 ) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.
STUDY DESIGN


Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.
MAIN OUTCOME MEASURES


Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.
SECONDARY OUTCOMES


maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.
CONCLUSIONS


BP 2  will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.",2020,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"['women who had HDP in their preceding pregnancy', 'Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480', 'Women who had hypertensive disorders of pregnancy (HDP']","['LBC counselling at a specialised clinic with an obstetric physician and dietitian 6\xa0months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6\xa0month telephone-based LBC program', 'Optimised usual care: information package and family doctor follow-up 6\xa0months postpartum 2']","['Blood pressure postpartum (BP 2 ', 'BP change or (b) weight change and/or waist circumference change', 'maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios', 'systolic BP', 'lifestyle behaviour change (LBC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0589124', 'cui_str': 'Follow-up 6 months'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",480.0,0.118249,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia. Electronic address: Amanda.Henry@unsw.edu.au.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Sydney, Australia; School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Hennessy', 'Affiliation': 'School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Beech', 'Affiliation': 'Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pettit', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Se Homer', 'Affiliation': 'Burnet Institute, Melbourne, Victoria, Australia; Faculty of Health, University of Technology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hyett', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Chambers', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Fitzgerald', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mann', 'Affiliation': 'General Practitioner, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Royal Hospital for Women, Randwick, New South Wales, Australia.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gale', 'Affiliation': 'New South Wales Ministry of Health, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ruhotas', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Kirwin', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Denney-Wilson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.001']
1453,32632523,Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity.,"BACKGROUND


Due to the SARS-CoV2 pandemic, medical face masks are widely recommended for a large number of individuals and long durations. The effect of wearing a surgical and a FFP2/N95 face mask on cardiopulmonary exercise capacity has not been systematically reported.
METHODS


This prospective cross-over study quantitated the effects of wearing no mask (nm), a surgical mask (sm) and a FFP2/N95 mask (ffpm) in 12 healthy males (age 38.1 ± 6.2 years, BMI 24.5 ± 2.0 kg/m 2 ). The 36 tests were performed in randomized order. The cardiopulmonary and metabolic responses were monitored by ergo-spirometry and impedance cardiography. Ten domains of comfort/discomfort of wearing a mask were assessed by questionnaire.
RESULTS


The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± 1.6 l/s; p < 0.001). The maximum power was 269 ± 45, 263 ± 42 and 277 ± 46 W with sm, ffpm and nm, respectively; p = 0.002; the ventilation was significantly reduced with both face masks (131 ± 28 vs 114 ± 23 vs 99 ± 19 l/m; p < 0.001). Peak blood lactate response was reduced with mask. Cardiac output was similar with and without mask. Participants reported consistent and marked discomfort wearing the masks, especially ffpm.
CONCLUSION


Ventilation, cardiopulmonary exercise capacity and comfort are reduced by surgical masks and highly impaired by FFP2/N95 face masks in healthy individuals. These data are important for recommendations on wearing face masks at work or during physical exercise.",2020,"The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± ","['12 healthy males (age 38.1\u2009±\u20096.2\xa0years, BMI 24.5\u2009±\u20092.0\xa0kg/m 2 ', 'healthy individuals']","['wearing a surgical and a FFP2/N95 face mask', 'wearing no mask (nm), a surgical mask (sm) and a FFP2/N95 mask', 'surgical and FFP2/N95 face masks']","['Cardiac output', 'Peak blood lactate response', 'ventilation', 'pulmonary function parameters', 'cardiopulmonary exercise capacity', 'cardiopulmonary and metabolic responses']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",12.0,0.0184074,"The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± ","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Fikenzer', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany. sven.fikenzer@medizin.uni-leipzig.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Uhe', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lavall', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Rudolph', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Falz', 'Affiliation': 'Institut für Sportmedizin und Prävention, Universität Leipzig, Marschner Str. 29, 04109, Leipzig, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Busse', 'Affiliation': 'Institut für Sportmedizin und Prävention, Universität Leipzig, Marschner Str. 29, 04109, Leipzig, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hepp', 'Affiliation': 'Klinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01704-y']
1454,32634745,"Examining sex, adverse childhood experiences, and oxytocin on neuroendocrine reactivity in smokers.","Adverse childhood experiences (ACE) are associated with greater neuroendocrine responses to social stress in substance users. The neuropeptide oxytocin might attenuate this relationship. Given sex differences in ACE exposure and neuroendocrine stress reactivity, it is unknown whether this association is similar for males and females. Therefore, this secondary analysis evaluated the interactive effect of sex, ACE, and acute oxytocin administration on neuroendocrine stress responses in adult cigarette smokers (N = 144). Participants completed the Adverse Childhood Experiences Questionnaire at screening and were randomized to receive intranasal oxytocin or placebo before undergoing the Trier Social Stress Task (TSST). Cortisol levels were assessed at pre- and post-medication administration and at 20 and 40 min following the TSST. Generalized linear mixed models were developed to predict post-TSST cortisol levels. Predictors included treatment assignment (placebo vs. oxytocin), sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration. The hypothesized three-way interaction between sex, oxytocin, and ACE scores was significant. Linear associations between ACE scores and cortisol reactivity indicated higher ACE scores were associated with attenuated cortisol response in females, regardless of treatment condition. For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin. Results indicate that the association between ACE and neuroendocrine reactivity to social stress, as well as the attenuating effect of oxytocin, is differentially impacted by sex. Males with greater childhood adversity may be more likely to benefit from oxytocin's anxiolytic properties.",2020,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","['adult cigarette smokers (N\u2009=\u2009144', 'smokers', 'Participants completed the Adverse Childhood Experiences Questionnaire at screening']","['oxytocin', 'treatment assignment (placebo vs. oxytocin', 'neuropeptide oxytocin', 'intranasal oxytocin or placebo', 'oxytocin administration']","['sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration', 'cortisol response', 'ACE scores', 'Cortisol levels', 'ACE scores and cortisol reactivity indicated higher ACE scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4284014', 'cui_str': 'Adverse Childhood Experience questionnaire'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0291417,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","[{'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, College of Arts & Sciences, University of Kentucky, United States. Electronic address: caitlyn.hood@uky.edu.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Breanna M', 'Initials': 'BM', 'LastName': 'Tuck', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, United States.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Ralph H. Johnson VA Medical Center, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Saladin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States; Department of Health Sciences and Research, College of Health Professions, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104752']
1455,32651161,"Repeated 5-day cycles of low dose aldesleukin in amyotrophic lateral sclerosis (IMODALS): A phase 2a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Low-dose interleukin-2 (ld-IL-2) enhances regulatory T-cell (Treg) function in auto-inflammatory conditions. Neuroinflammation being a pathogenic feature of amyotrophic lateral sclerosis (ALS), we evaluated the pharmacodynamics and safety of ld-IL-2 in ALS subjects.
METHODS


We performed a single centre, parallel three-arm, randomised, double-blind, placebo-controlled study. Eligibility criteria included age < 75 years, disease duration < 5 years, riluzole treatment > 3 months, and a slow vital capacity ≥ 70% of normal. Patients were randomised (1:1:1) to aldesleukin 2 MIU, 1 MIU, or placebo once daily for 5 days every 4 weeks for 3 cycles. Primary outcome was change from baseline in Treg percentage of CD4 +  T cells (%Tregs) following a first cycle. Secondary laboratory outcomes included: %Treg and Treg number following repeated cycles, and plasma CCL2 and neurofilament light chain protein (NFL) concentrations as surrogate markers of efficacy. Safety outcomes included motor-function (ALSFRS-R), slow vital capacity (SVC), and adverse event reports. This trial is registered with ClinicalTrials.gov, NCT02059759.
FINDINGS


All randomised patients (12 per group), recruited from October 2015 to December 2015, were alive at the end of follow-up and included in the intent-to-treat (ITT) analysis. No drug-related serious adverse event was observed. Non-serious adverse events occurred more frequently with the 1 and 2 MIU IL-2 doses compared to placebo, including injection site reactions and flu-like symptoms. Primary outcome analysis showed a significant increase (p < 0·0001) in %Tregs in the 2 MIU and 1 MIU arms (mean [SD]: 2 MIU: +6·2% [2·2]; 1 MIU: +3·9% [1·2]) as compared to placebo (mean [SD]: -0·49% [1·3]). Effect sizes (ES) were large in treated groups: 2 MIU ES=3·7 (IC95%: 2·3-4·9) and 1 MIU ES=3·5 (IC95%: 2·1-4·6). Secondary outcomes showed a significant increase in %Tregs following repeated cycles (p < 0·0001) as compared to placebo, and a dose-dependent decrease in plasma CCL2 (p = 0·0049). There were no significant differences amongst the three groups on plasma NFL levels.
INTERPRETATION


Ld-IL-2 is well tolerated and immunologically effective in subjects with ALS. These results warrant further investigation into their eventual therapeutic impact on slowing ALS disease progression.
FUNDING


The French Health Ministry (PHRC-I-14-056), EU H2020 (grant #633413), and the Association pour la Recherche sur la SLA (ARSLA).",2020,"Non-serious adverse events occurred more frequently with the 1 and 2 MIU IL-2 doses compared to placebo, including injection site reactions and flu-like symptoms.","['Eligibility criteria included age', 'amyotrophic lateral sclerosis (IMODALS', 'subjects with ALS', 'ALS subjects', 'All randomised patients (12 per group), recruited from October 2015 to December 2015, were alive at the end of follow-up and included in the intent-to-treat (ITT) analysis']","['riluzole treatment', 'aldesleukin 2 MIU, 1 MIU, or placebo', 'placebo']","['motor-function (ALSFRS-R), slow vital capacity (SVC), and adverse event reports', 'injection site reactions and flu-like symptoms', 'change from baseline in Treg percentage of CD4 +  T cells', 'disease duration', 'plasma NFL levels', 'plasma CCL2 and neurofilament light chain protein (NFL) concentrations', 'plasma CCL2']","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0218986', 'cui_str': 'Aldesleukin'}, {'cui': 'C0439455', 'cui_str': 'mIU'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1449159', 'cui_str': 'CCL2 protein, human'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0427716', 'cui_str': 'Protein concentration, test strip measurement'}]",,0.755312,"Non-serious adverse events occurred more frequently with the 1 and 2 MIU IL-2 doses compared to placebo, including injection site reactions and flu-like symptoms.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Camu', 'Affiliation': 'Clinique du Motoneurone, CHU Gui de Chauliac, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Mickunas', 'Affiliation': ""Department Immunobiology, Faculty of Life Sciences and Medicine, King's College London, London, UK; NIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK.""}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Veyrune', 'Affiliation': 'Department of Cell and Tisue Engineering, University of Montpellier, CHU Montpellier, Montpellier France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Payan', 'Affiliation': ""Department of Biostatistics, Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), Nîmes University Hospital, Nîmes, France; Department of Pharmacology, AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 47, Bd de l'Hôpital, F-75013 Paris, France.""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Garlanda', 'Affiliation': 'IRCCS Humanitas Clinical & Research Institute, Milan, Italy; Humanitas University, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Locati', 'Affiliation': 'IRCCS Humanitas Clinical & Research Institute, Milan, Italy; Department of Medical Biotechnologies and Translational Medicine, University Milan, Milan Italy.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Juntas-Morales', 'Affiliation': 'Clinique du Motoneurone, CHU Gui de Chauliac, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Pageot', 'Affiliation': 'Clinique du Motoneurone, CHU Gui de Chauliac, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Malaspina', 'Affiliation': 'Neuroscience and Trauma Centre, Institute of Cell and Molecular Medicine, Department of Neuroimmunology, Barts and the London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Andreasson', 'Affiliation': 'Department of Psychiatry & Neurochemistry, University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Kirby', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, Department of Neuroscience, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Suehs', 'Affiliation': 'Departments of Medical Information and Respiratory Diseases, University of Montpellier, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Saker', 'Affiliation': 'DNA and Cell Bank, Genethon, Evry, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Masseguin', 'Affiliation': 'Delegation for Clinical Research and Innovation, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'De Vos', 'Affiliation': 'Department of Cell and Tisue Engineering, University of Montpellier, CHU Montpellier, Montpellier France.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Department of Psychiatry & Neurochemistry, University of Gothenburg, Mölndal, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Department of Neurodegenerative Disease, UCL Institute of Neurology, Queen Square, London, UK; UK Dementia Research Institute at UCL, London, UK.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Shaw', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, Department of Neuroscience, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Al-Chalabi', 'Affiliation': ""Institute of Psychiatry Psychology and Neuroscience, Department of Basic and Clinical Neuroscience, King's College London, London, UK; Department of Neurology, King's College Hospital, London, UK.""}, {'ForeName': 'P Nigel', 'Initials': 'PN', 'LastName': 'Leigh', 'Affiliation': 'The Trafford Centre for Biomedical Research, Brighton and Sussex Medical School, Falmer, Brighton BN1 9RY, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Tree', 'Affiliation': ""Department Immunobiology, Faculty of Life Sciences and Medicine, King's College London, London, UK; NIHR Biomedical Research Centre, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, UK. Electronic address: timothy.tree@kcl.ac.uk.""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Bensimon', 'Affiliation': ""Department of Biostatistics, Clinical Epidemiology, Public Health and Innovation in Methodology (BESPIM), Nîmes University Hospital, Nîmes, France; Department of Pharmacology, AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 47, Bd de l'Hôpital, F-75013 Paris, France; Department of Pharmacology, Sorbonne Université Médecine, F-75013 Paris, France. Electronic address: gbensimon.psl@gmail.com.""}]",EBioMedicine,['10.1016/j.ebiom.2020.102844']
1456,32650604,Nine Months of a Structured Multisport Program Improve Physical Fitness in Preschool Children: A Quasi-Experimental Study.,"Research in preschool children that investigates the impact of different exercise interventions on physical fitness is limited. This pre-post study was aimed at determining if participation in a nine-month structured multisport program (MSG; n = 38) could enhance physical fitness components compared to a formal exercise program (control group (CG); n = 36) among preschool children. Physical fitness was assessed using standardized tests (the standing long jump, sit and reach, 20 m sprint, sit-ups for 30 s, bent-arm hang, medicine ball throw (MBT), grip strength, 4 × 10 m shuttle run, and 20 m shuttle run tests). The structured multisport program involved fundamental/gross and fine motor skills and ball game-based exercises twice a week. The control group was free of any programmed exercise except for the obligatory program in kindergartens. A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p  < 0.05). There was no significant group-by-time interaction effect for the 20 m sprint test ( p  = 0.794) or for the 20 m shuttle run test ( p  = 0.549). Moreover, the MSG and CG performance in the MBT and 20 m shuttle run tests improved to a similar extent from pre- to post-test. Our results indicate that compared to the formal plan, the structured multisport program led to a sustained improvement in physical fitness in healthy 5-to-6-year old children.",2020,"A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p  < 0.05).","['Preschool Children', 'n = 36) among preschool children', 'healthy 5-to-6-year old children', 'preschool children']","['structured multisport program involved fundamental/gross and fine motor skills and ball game-based exercises twice a week', 'exercise interventions', 'Structured Multisport Program', 'physical fitness components compared to a formal exercise program (control group (CG']","['Physical Fitness', 'time interaction effect', 'physical fitness', 'Physical fitness', 'MSG and CG performance']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",38.0,0.019258,"A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p  < 0.05).","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Popović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Cvetković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Draženka', 'Initials': 'D', 'LastName': 'Mačak', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Tijana', 'Initials': 'T', 'LastName': 'Šćepanović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Čokorilo', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Belić', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Trajković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Andrašić', 'Affiliation': 'Faculty of Economics, University of Novi Sad, 24000 Subotica, Serbia.'}, {'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'Faculty of Sport, University of Ljubljana, 1000 Ljubljana, Slovenia.'}]",International journal of environmental research and public health,['10.3390/ijerph17144935']
1457,32653580,Investigation of the Effects of Dual-Task Balance Training on Gait and Balance in Transfemoral Amputees: A Randomized Controlled Trial.,"OBJECTIVES


To investigate the effects of dual-task balance training on static and dynamic balance, functional mobility, cognitive level, and sleep quality in individuals with transfemoral amputation.
DESIGN


Randomized controlled clinical trial.
PARTICIPANTS


Transfemoral amputees (N=20).
INTERVENTIONS


Participants were randomly assigned to the single-task gait and balance training group (n=10) or the dual-task gait and balance training group (n=10). Training was given in sessions of 60 min/d, 3 d/wk for 4 weeks. The single-task training group performed traditional gait and balance exercises, and the dual-task training group practiced cognitive and motor tasks while performing gait and balance exercises.
MAIN OUTCOME MEASURES


The 1-leg stance test and the Four Square Step Test were used for balance assessment. The timed Up and Go test and 10-m walk test were used for gait assessment. Three test conditions to evaluate the training effects were single walking, walking while performing a cognitive task (serial subtraction), and walking while performing a motor task (tray carrying). The Montreal Cognitive Assessment scale was used for cognitive assessment and the Pittsburgh Sleep Quality Index for sleep quality assessment.
RESULTS


Balance and mobility improved in both groups. Dual-task balance performance, functional mobility, and gait speed improved more in the dual-task training group after training (P<.05). Cognitive status and sleep quality improved significantly in the dual-task group (P<.05).
CONCLUSIONS


Dual-task training was more effective than single-task training in the improvement of dual-task performance and cognitive status. The inclusion of dual-task exercises in the rehabilitation program of transfemoral amputees will provide a different perspective because of increased task automation.",2020,"Dual task balance performance, functional mobility and gait speed improved more in the dual task training group after training (p <0.05).","['Transfemoral amputees (n=20', 'Transfemoral Amputees', 'individuals with transfemoral amputation']","['single task gait and balance training group (n=10) or the dual task task gait and balance training group', 'single task training group performed traditional gait and balance exercises, and the dual task training group practised cognitive and motor tasks while performing gait and balance exercises', 'single walking, walking while performing a cognitive task (serial subtraction), and walking while performing a motor task (tray-carrying', 'dual task balance training', 'Dual Task Balance Training', 'Dual-task training']","['Balance and mobility', 'cognitive assessment and the Pittsburgh Sleep Quality Index for sleep quality assessment', 'Gait and Balance', 'Montreal Cognitive Assessment scale', 'static and dynamic balance, functional mobility, cognitive level, and sleep quality', 'dual task performance and cognitive status', 'leg stance test and the four-square step test', 'Dual task balance performance, functional mobility and gait speed', 'Cognitive status and sleep quality']","[{'cui': 'C0002695', 'cui_str': 'Amputee'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002691', 'cui_str': 'Amputation above-knee'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0184054', 'cui_str': 'Tray'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",,0.014124,"Dual task balance performance, functional mobility and gait speed improved more in the dual task training group after training (p <0.05).","[{'ForeName': 'Senem', 'Initials': 'S', 'LastName': 'Demirdel', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey. Electronic address: fzt_sb@hotmail.com.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Erbahçeci', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.06.009']
1458,32660769,"Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects: A Randomized, Double-blind Trial.","PURPOSE


MSB11455 is a proposed biosimilar to the reference pegfilgrastim (Neulasta®). This pivotal equivalence study (NCT03251248) assessed the pharmacokinetic and pharmacodynamic equivalence of MSB11455 to the reference product.
METHODS


This 2-way, 2-sequence, group-sequential, crossover study was conducted in healthy subjects. Subjects received a single subcutaneous dose of MSB11455 or the reference product (both 6 mg/0.6 mL) on Day 1 of each study period. Pharmacokinetic and pharmacodynamic (absolute neutrophil count; ANC) samples were taken predose and up to day 16 post-dose. Non-compartmental parameters were calculated. Immunogenicity samples were taken pre-dose and up to day 84 after the first dose. Safety was assessed throughout the study.
FINDINGS


A total of 292 subjects were randomized to therapy and treated; 244 received both treatments. For all primary pharmacokinetic and pharmacodynamic parameters, 90% repeated confidence intervals of geometric means ratio of MSB11455 to the reference product were within the pre-defined equivalence range (80.00%-125.00%) for AUC 0-∞  (96.59-112.82); AUC 0-last  (97.29-113.96), C max  (97.13-114.99), maximum observed effect on ANC (98.74-102.39), and area under the effect-time curve from time zero to time to last quantifiable concentration (97.30-100.23). Safety, tolerability, and immunogenicity were comparable between treatments. No filgrastim-specific neutralizing antibodies were detected with either treatment sequence.
IMPLICATIONS


Pharmacokinetic and pharmacodynamic equivalence of MSB11455 and the reference product was shown, with comparable immunogenicity, safety, and tolerability between treatments. The study supports the biosimilarity of MSB11455 to the reference product. ClinicalTrials.gov identifier: NCT03251248.",2020,"Safety, tolerability, and immunogenicity were comparable between treatments.","['292 subjects', 'healthy subjects', 'Healthy Subjects']","['MSB11455', 'Pegfilgrastim Biosimilar MSB11455']","['Safety', 'Safety, tolerability, and immunogenicity', 'immunogenicity, safety, and tolerability', 'Immunogenicity samples', 'Pharmacokinetic and pharmacodynamic (absolute neutrophil count; ANC) samples']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}]",292.0,0.056325,"Safety, tolerability, and immunogenicity were comparable between treatments.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, Australia.'}, {'ForeName': 'Radmila', 'Initials': 'R', 'LastName': 'Kanceva', 'Affiliation': 'Biosimilars, Fresenius Kabi SwissBioSim, Eysins, Switzerland. Electronic address: Radmila.Kanceva@fresenius-kabi.com.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Vincent', 'Affiliation': 'Biosimilars, Fresenius Kabi SwissBioSim, Eysins, Switzerland.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schueler', 'Affiliation': 'Biostatistics, Merck Healthcare, Darmstadt, Germany.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Harrison-Moench', 'Affiliation': 'Quantitative Pharmacology, Merck Healthcare, Darmstadt, Germany.'}, {'ForeName': 'Corinne Seng', 'Initials': 'CS', 'LastName': 'Yue', 'Affiliation': 'Learn and Confirm, Inc., St-Laurent, Québec, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stahl', 'Affiliation': 'Biosimilars, Fresenius Kabi SwissBioSim, Eysins, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ullmann', 'Affiliation': 'Biosimilars, Fresenius Kabi SwissBioSim, Eysins, Switzerland.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Ghori', 'Affiliation': 'Biosimilars, Fresenius Kabi SwissBioSim, Eysins, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Griffin', 'Affiliation': 'School of Medicine, University of Queensland, Brisbane, Australia; Department of Medicine and Infectious Diseases, Mater Hospital and Mater Medical Research Institute, Brisbane, Queensland, Australia.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.020']
1459,32667155,Muscular Tissue Oxygen Saturation and Posthysterectomy Nausea and Vomiting: The iMODIPONV Randomized Controlled Trial.,"BACKGROUND


Suboptimal tissue perfusion and oxygenation during surgery may be responsible for postoperative nausea and vomiting in some patients. This trial tested the hypothesis that muscular tissue oxygen saturation-guided intraoperative care reduces postoperative nausea and vomiting.
METHODS


This multicenter, pragmatic, patient- and assessor-blinded randomized controlled (1:1 ratio) trial was conducted from September 2018 to June 2019 at six teaching hospitals in four different cities in China. Nonsmoking women, 18 to 65 yr old, and having elective laparoscopic surgery involving hysterectomy (n = 800) were randomly assigned to receive either intraoperative muscular tissue oxygen saturation-guided care or usual care. The goal was to maintain muscular tissue oxygen saturation, measured at flank and on forearm, greater than baseline or 70%, whichever was higher. The primary outcome was 24-h postoperative nausea and vomiting. Secondary outcomes included nausea severity, quality of recovery, and 30-day morbidity and mortality.
RESULTS


Of the 800 randomized patients (median age, 50 yr [range, 27 to 65]), 799 were assessed for the primary outcome. The below-goal muscular tissue oxygen saturation area under the curve was significantly smaller in patients receiving muscular tissue oxygen saturation-guided care (n = 400) than in those receiving usual care (n = 399; flank, 50 vs. 140% · min, P < 0.001; forearm, 53 vs. 245% · min, P < 0.001). The incidences of 24-h postoperative nausea and vomiting were 32% (127 of 400) in the muscular tissue oxygen saturation-guided care group and 36% (142 of 399) in the usual care group, which were not significantly different (risk ratio, 0.89; 95% CI, 0.73 to 1.08; P = 0.251). There were no significant between-group differences for secondary outcomes. No harm was observed throughout the study.
CONCLUSIONS


In a relatively young and healthy female patient population, personalized, goal-directed, muscular tissue oxygen saturation-guided intraoperative care is effective in treating decreased muscular tissue oxygen saturation but does not reduce the incidence of 24-h posthysterectomy nausea and vomiting.",2020,"The incidences of 24-h postoperative nausea and vomiting were 32% (127 of 400) in the muscular tissue oxygen saturation-guided care group and 36% (142 of 399) in the usual care group, which were not significantly different (risk ratio, 0.89; 95% CI, 0.73 to 1.08; P = 0.251).","['September 2018 to June 2019 at six teaching hospitals in four different cities in China', 'Nonsmoking women, 18 to 65 yr old, and having elective laparoscopic surgery involving hysterectomy (n = 800', '800 randomized patients (median age, 50 yr [range, 27 to 65']","['muscular tissue oxygen saturation-guided intraoperative care', 'intraoperative muscular tissue oxygen saturation-guided care or usual care']","['postoperative nausea and vomiting', '24-h postoperative nausea and vomiting', 'nausea severity, quality of recovery, and 30-day morbidity and mortality', 'Muscular Tissue Oxygen Saturation and Posthysterectomy Nausea and Vomiting', 'incidences of 24-h postoperative nausea and vomiting', 'muscular tissue oxygen saturation']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021889', 'cui_str': 'Intraoperative care'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",800.0,0.311572,"The incidences of 24-h postoperative nausea and vomiting were 32% (127 of 400) in the muscular tissue oxygen saturation-guided care group and 36% (142 of 399) in the usual care group, which were not significantly different (risk ratio, 0.89; 95% CI, 0.73 to 1.08; P = 0.251).","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'From the Department of Anesthesiology, Peking University Third Hospital, Beijing, China (G.L., X.G.) the Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China (D.-D.T., Y.-Q.A., J.-J.Y.) the Department of Anesthesiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong Province, China (X.W., M.Z.) the Department of Anesthesiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China (X.F., Y.L.) the Department of Anesthesiology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China (W.Z., M.X., X.C.) the Department of Anesthesiology, Peking University First Hospital, Beijing, China (J.B., D.-X.W., D.-L.M.) the Department of Biostatistics, Yale University School of Public Health, Yale Center for Analytical Sciences, New Haven, Connecticut (F.D.) the Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut (X.Z., D.Y., L.M.).'}, {'ForeName': 'Dan-Dan', 'Initials': 'DD', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Xiaoxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Dong-Xin', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Ai', 'Affiliation': ''}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Dong-Liang', 'Initials': 'DL', 'LastName': 'Mu', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Dai', 'Affiliation': ''}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Che', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yanez', 'Affiliation': ''}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Lingzhong', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003305']
1460,32666202,Pilot study of tenofovir disoproxil fumarate and pegylated interferon-alpha 2a add-on therapy in Japanese patients with chronic hepatitis B.,"BACKGROUND


A prospective pilot study of tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha 2a (P-IFN) add-on therapy was conducted to evaluate its efficacy in reducing viral antigen levels in Japanese patients with chronic hepatitis B (UMIN 000020179).
METHODS


Patients with chronic hepatitis B receiving maintenance TDF therapy and exhibiting hepatitis B surface antigen (HBsAg) level > 800 IU/ml were divided into two arms. P-IFN was added for 48 weeks in the add-on arm (n = 32), while TDF monotherapy was maintained in the control arm (n = 51). Both groups were followed for 96 weeks after baseline measurements.
RESULTS


Almost all patients in the control arm displayed a slow and constant reduction in HBsAg during follow-up. In contrast, roughly half of the add-on arm exhibited a sharp decline in HBsAg during P-IFN administration, which disappeared after halting P-IFN. At 96 weeks after baseline, 41% (13/32) of patients in the add-on arm had shown a rapid decrease in HBsAg, versus 2% (1/51) in the control arm (p < 0.001). Add-on therapy and increased cytotoxic T-cell response were significant factors associated with a rapid decrease in HBsAg according to multivariate analysis. In addition, higher HB core-related antigen (HBcrAg) level at baseline (p = 0.001) and add-on therapy (p = 0.036) were significant factors associated with a rapid reduction in HBcrAg.
CONCLUSIONS


TDF and P-IFN add-on therapy in Japanese patients with chronic hepatitis B facilitated rapid decreases in HBsAg and HBcrAg. Further studies are needed to improve early HBsAg clearance rate.",2020,"In addition, higher HB core-related antigen (HBcrAg) level at baseline (p = 0.001) and add-on therapy (p = 0.036) were significant factors associated with a rapid reduction in HBcrAg.
","['Japanese patients with chronic hepatitis B', 'Japanese patients with chronic hepatitis B (UMIN 000020179', 'Patients with chronic hepatitis B receiving maintenance TDF therapy and exhibiting hepatitis B surface antigen (HBsAg) level\u2009>\u2009800\xa0IU']","['tenofovir disoproxil fumarate and pegylated interferon-alpha 2a add', 'TDF monotherapy', 'tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha 2a (P-IFN', 'TDF and P-IFN']","['HBsAg', 'slow and constant reduction in HBsAg', 'cytotoxic T-cell response', 'viral antigen levels', 'higher HB core-related antigen (HBcrAg) level']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0021734', 'cui_str': 'Interferon Alfa-2a'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0039195', 'cui_str': 'Cytotoxic T lymphocyte'}, {'cui': 'C0003342', 'cui_str': 'Viral antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}]",,0.0593133,"In addition, higher HB core-related antigen (HBcrAg) level at baseline (p = 0.001) and add-on therapy (p = 0.036) were significant factors associated with a rapid reduction in HBcrAg.
","[{'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Medicine, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nishiguchi', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Hirayuki', 'Initials': 'H', 'LastName': 'Enomoto', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Disease, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Shinkai', 'Affiliation': 'Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Okuse', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kawasaki Municipal Tama Hospital, Kawasaki, Japan.'}, {'ForeName': 'Jong-Hon', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Matsui', 'Affiliation': 'Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan.'}, {'ForeName': 'Shiho', 'Initials': 'S', 'LastName': 'Miyase', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kumamoto Shinto General Hospital, Kumamoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yatsuhashi', 'Affiliation': 'The Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Omura, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Nagaoka', 'Affiliation': 'The Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Omura, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Kanda', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Enomoto', 'Affiliation': 'Department of Hepatology, Osaka City University Medical School, Osaka, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hiramatsu', 'Affiliation': 'Department of Gastroenterology, Osaka Rosai Hospital, Sakai, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takaguchi', 'Affiliation': 'Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.'}, {'ForeName': 'Kiyoaki', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Division of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University School of Medicine, Nagakute, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Masaki', 'Affiliation': 'Department of Gastroenterology and Neurology, Kagawa University School of Medicine, Kagawa, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Morihara', 'Affiliation': 'Department of Gastroenterology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Tsuge', 'Affiliation': 'Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Chayama', 'Affiliation': 'Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Fusao', 'Initials': 'F', 'LastName': 'Ikeda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Tatehiro', 'Initials': 'T', 'LastName': 'Kagawa', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Japan.'}, {'ForeName': 'Yasuteru', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Hepatology, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Kazumoto', 'Initials': 'K', 'LastName': 'Murata', 'Affiliation': 'Division of Virology, Department of Infection and Immunity, Jichi Medical University School of Medicine, Shimotsuke, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Tanaka', 'Affiliation': 'Department for the Promotion of Regional Medicine, Shinshu University School of Medicine, Asahi 3-1-1, Matsumoto, 390-8621, Japan. etanaka@shinshu-u.ac.jp.'}]",Journal of gastroenterology,['10.1007/s00535-020-01707-6']
1461,32663909,"Randomized, Double-Blind, Placebo-Controlled Trial of the mGlu2/3 Negative Allosteric Modulator Decoglurant in Partially Refractory Major Depressive Disorder.","OBJECTIVE


To assess putative antidepressant and procognitive effects of decoglurant, a selective metabotropic glutamate receptor type 2/3 (mGlu2/3) negative allosteric modulator, as adjunctive treatment to selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs) in patients with partially refractory major depressive disorder (MDD), diagnosed using DSM-IV-TR criteria.
METHODS


This randomized, placebo-controlled, double-blind, multicenter phase 2 trial consisted of 4 weeks' screening, 6 weeks' treatment, and 8 weeks' follow-up between September 2011 and June 2014. Individuals with Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 25 and Clinical Global Impressions-Severity of Illness scale score ≥ 4, despite up to 2 adequate trials of an SSRI/SNRI and compliance confirmed by positive SSRI/SNRI blood levels, were randomized to decoglurant 5 mg (n = 101), 15 mg (n = 102), or 30 mg (n = 55) daily or placebo (n = 99) as adjunct to ongoing treatment with 1 SSRI/SNRI. An adaptive design was used with an interim analysis after 30 patients in each group had received 6 weeks' treatment. The primary outcome variable was change in MADRS total score from baseline to end of treatment. Primary assessments were performed by fully blinded centralized raters.
RESULTS


Of 357 participants, 310 completed 6 weeks' treatment. At 6 weeks, no significant differences between any active treatment arm and placebo in reducing MADRS total score or response or remission rates were observed. Decoglurant exerted no significant effects on Cambridge Neuropsychological Test Automated Battery cognitive accuracy and cognitive speed composite scores or on secondary measures of mood and functioning. A relatively high placebo response was observed, which may have constrained the ability to detect treatment effects. No deaths occurred; few patients reported serious adverse events.
CONCLUSIONS


Decoglurant was well tolerated overall but did not exert any antidepressant or procognitive effects.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01457677.",2020,Decoglurant exerted no significant effects on Cambridge Neuropsychological Test Automated Battery cognitive accuracy and cognitive speed composite scores or on secondary measures of mood and functioning.,"['patients with partially refractory major depressive disorder (MDD), diagnosed using DSM-IV-TR criteria', 'Individuals with Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 25 and Clinical Global Impressions-Severity of Illness scale score ≥ 4, despite up to 2 adequate trials of an SSRI/SNRI and compliance confirmed by positive SSRI/SNRI blood levels', 'Partially Refractory Major Depressive Disorder', '357 participants']","['placebo', 'Placebo', 'serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs', 'mGlu2/3 Negative Allosteric Modulator Decoglurant']","['Cambridge Neuropsychological Test Automated Battery cognitive accuracy and cognitive speed composite scores', 'MADRS total score or response or remission rates', 'change in MADRS total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1579361', 'cui_str': 'SSRIs and NRIs'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1579361', 'cui_str': 'SSRIs and NRIs'}, {'cui': 'C0206529', 'cui_str': 'Metabotropic Glutamate Receptor'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C4505411', 'cui_str': 'CANTAB'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.65258,Decoglurant exerted no significant effects on Cambridge Neuropsychological Test Automated Battery cognitive accuracy and cognitive speed composite scores or on secondary measures of mood and functioning.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Umbricht', 'Affiliation': 'Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Bldg 1/Room 16.N655, Grenzacherstrasse 124, 4070 Basel, Switzerland. daniel.umbricht@roche.com.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Niggli', 'Affiliation': 'Roche Product Development Biometrics, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sanwald-Ducray', 'Affiliation': 'Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Deptula', 'Affiliation': 'Roche Pharmaceutical Research and Early Development, Roche Innovation Center New York, F. Hoffmann-La Roche Ltd, New York, New York, USA.'}, {'ForeName': 'Rema', 'Initials': 'R', 'LastName': 'Moore', 'Affiliation': 'Roche Pharmaceutical Research and Early Development, Roche Innovation Center New York, F. Hoffmann-La Roche Ltd, New York, New York, USA.'}, {'ForeName': 'Waltraud', 'Initials': 'W', 'LastName': 'Grünbauer', 'Affiliation': 'Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Boak', 'Affiliation': 'Roche Product Development Neuroscience, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Fontoura', 'Affiliation': 'Roche Product Development Neuroscience, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}]",The Journal of clinical psychiatry,['10.4088/JCP.18m12470']
1462,32664535,Manipulative Therapy Plus Ankle Therapeutic Exercises for Adolescent Baseball Players with Chronic Ankle Instability: A Single-Blinded Randomized Controlled Trial.,"Manipulative therapies and exercises are commonly used for the management of chronic ankle instability (CAI), but there is no evidence regarding the efficacy of high-velocity low-amplitude manipulation (HVLA) in addition to ankle therapeutic exercise to improve CAI in adolescent baseball players (ABP). To compare the effects of HVLA plus ankle therapeutic exercise and ankle therapeutic exercise alone on ankle status, pain intensity, pain pressure threshold (PPT), range of motion (ROM) of the ankle joint, and balance ability in ABP with CAI, a single-blinded randomized controlled trial was conducted. A total of 31 ABP with CAI were randomly allocated to the intervention (n = 16) or control (n = 15) groups. The intervention group received HVLA plus resistance exercise twice a week for 4 weeks, while the control group received resistance exercise alone. Ankle status, pain intensity, PPT, ROM, and balance ability were assessed before and after the intervention. The American Orthopedic Foot and Ankle Society scores showed significant group and time interactions (total,  p  = 0.002; pain,  p  < 0.001; alignment,  p  = 0.001). There were significant group and time interactions in pain intensity (resting pain,  p  = 0.008; movement pain,  p  < 0.001). For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026). The unipedal stance of the balance ability showed significant group and time interactions in path length ( p  = 0.006) and velocity ( p  = 0.006). Adding HVLA to resistance exercises may be synergistically effective in improving the ankle status, pain intensity, ROM, and balance ability in ABP with CAI.",2020,"For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026).","['A total of 31 ABP with CAI', 'Adolescent Baseball Players with Chronic Ankle Instability', 'adolescent baseball players (ABP']","['Manipulative Therapy Plus Ankle Therapeutic Exercises', 'Manipulative therapies and exercises', 'resistance exercise alone', 'HVLA plus ankle therapeutic exercise and ankle therapeutic exercise alone', 'HVLA plus resistance exercise']","['ankle status, pain intensity, ROM, and balance ability', 'time interactions in path length', 'Ankle status, pain intensity, PPT, ROM, and balance ability', 'time interactions in pain intensity (resting pain,  p  = 0.008; movement pain', 'time interactions on dorsiflexion', 'ankle status, pain intensity, pain pressure threshold (PPT), range of motion (ROM) of the ankle joint, and balance ability']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}]","[{'cui': 'C0949742', 'cui_str': 'Therapy, Manipulation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}]",31.0,0.0724231,"For ROM, there were significant group and time interactions on dorsiflexion ( p  = 0.006) and eversion ( p  = 0.026).","[{'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Sung-Hyeon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Han Jo', 'Initials': 'HJ', 'LastName': 'Jung', 'Affiliation': 'Graduate School of Integrative Medicine, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hwi-Young', 'Initials': 'HY', 'LastName': 'Cho', 'Affiliation': 'Department of Health Science, Gachon University Graduate School, Incheon 21936, Korea.'}, {'ForeName': 'Suk-Chan', 'Initials': 'SC', 'LastName': 'Hahm', 'Affiliation': 'Graduate School of Integrative Medicine, CHA University, Seongnam 13488, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17144997']
1463,32678489,The effectiveness of an indicated prevention programme for substance use in individuals with mild intellectual disabilities and borderline intellectual functioning: results of a quasi-experimental study.,"AIMS


To assess the effectiveness of Take it personal!, a prevention programme for individuals with mild intellectual disabilities and borderline intellectual functioning (MID-BIF) and substance use (SU). The prevention programme aims to reduce SU (alcohol, cannabis and illicit drugs) among experimental to problematic substance users.
DESIGN


A quasi-experimental design with two arms and a 3-month follow-up.
SETTING


Adolescents were recruited from 14 treatment centres in the Netherlands specialized in offering intra- and extramural care for people with MID-BIF and behavioural problems.
PARTICIPANTS


Data were collected from 66 individuals with MID-BIF assigned either to the intervention condition (n = 34) or to the control condition (n = 32).
INTERVENTIONS


Take it personal! was designed to target four personality traits: sensation-seeking, impulsive behaviour, anxiety sensitivity and negative thinking. For each of these profiles, interventions were developed that were structurally the same but contained different personality-specific materials, games and exercises. The control group received care as usual.
MEASUREMENTS


Primary outcomes at 3-month follow-up were frequency of SU, severity of SU and binge drinking.
RESULTS


Results showed intervention effects for SU frequency (F (1, 50.43)   = 9.27, P = 0.004) and binge drinking (F (1, 48.02)   = 8.63, P = 0.005), but not for severity of SU (F (1, 42.09)   = 2.20, P = 0.145).
CONCLUSIONS


A prevention programme to reduce substance use among experimental to problematic users with mild intellectual disabilities and borderline intellectual functioning helped participants to decrease substance use frequency and binge drinking.",2020,"The prevention programme aims to reduce SU (alcohol, cannabis, and illicit drugs) among experimental to problematic substance users.
","['individuals with mild intellectual disabilities and borderline intellectual functioning', 'Data were collected from 66 individuals with MID-BIF assigned either to the intervention condition (n=34) or to the control condition (n=32', 'Adolescents were recruited from 14 treatment centres in the Netherlands specialised in offering intra- and extramural care for people with MID-BIF and behavioural problems', 'individuals with mild intellectual disabilities and borderline intellectual functioning (MID-BIF) and substance use (SU']","['indicated prevention programme', 'SU (alcohol, cannabis, and illicit drugs']","['binge drinking', 'frequency of SU, severity of SU and binge drinking']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026106', 'cui_str': 'Mild intellectual disability'}, {'cui': 'C0006009', 'cui_str': 'Borderline intellectual disability'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}]","[{'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}]","[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",66.0,0.0308177,"The prevention programme aims to reduce SU (alcohol, cannabis, and illicit drugs) among experimental to problematic substance users.
","[{'ForeName': 'Esmée P', 'Initials': 'EP', 'LastName': 'Schijven', 'Affiliation': 'Research and Development, Pluryn, Nijmegen, the Netherlands.'}, {'ForeName': 'Daan H G', 'Initials': 'DHG', 'LastName': 'Hulsmans', 'Affiliation': 'Research and Development, Pluryn, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanneke E L', 'Initials': 'JEL', 'LastName': 'VanDerNagel', 'Affiliation': 'Tactus, Centre for Addiction and Intellectual Disability (CAID), Deventer, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Lammers', 'Affiliation': 'Trimbos Institute, Netherlands Institute of Mental Health and Addiction, Utrecht, the Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Otten', 'Affiliation': 'Research and Development, Pluryn, Nijmegen, the Netherlands.'}, {'ForeName': 'Evelien A P', 'Initials': 'EAP', 'LastName': 'Poelen', 'Affiliation': 'Research and Development, Pluryn, Nijmegen, the Netherlands.'}]","Addiction (Abingdon, England)",['10.1111/add.15156']
1464,32678852,The effect of comprehensive intervention for childhood obesity on dietary diversity among younger children: Evidence from a school-based randomized controlled trial in China.,"BACKGROUND


Little evidence from developing countries on dietary transition demonstrates the effects of comprehensive childhood obesity interventions on dietary diversity and food variety among younger children. This study aimed to evaluate the effects of comprehensive childhood obesity interventions on dietary diversity among younger children.
METHODS


A total of 4846 children aged 7-13 years were included based on a multicenter randomized controlled trial for childhood obesity interventions in 38 primary schools. Nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention including both NE and PA (CNP) were carried out separately for 2 semesters. Dietary Diversity Score (DDS9 and DDS28 for 9 and 28 food groupings, respectively), Food Variety Score (FVS, the number of food items) and the proportions of different foods consumed were calculated according to the food intake records collected with the 24-h dietary recall method.
RESULTS


The intervention effects per day of comprehensive intervention group were 0 (95% Confidence Interval (CI): 0, 0.1; p = 0.382) on DDS9, 0.1 (95% CI: -0.1, 0.2; p = 0.374) on DDS28 and 0.1 (95% CI: -0.1, 0.3; p = 0.186) on FVS of overall diet, which was 0.1 (95% CI: 0, 0.1; p < 0.001) on DDS9, 0 (95% CI: 0, 0.1; p = 0.168) on DDS28 and 0.1 (95% CI: 0, 0.1; p = 0.067) on FVS of dietary scores of breakfast only. Additionally, CNP group had greater increases in cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions as compared with the control group. Decreasing side effect on dietary diversity and food variety were found for PA intervention, but not for NE intervention only.
CONCLUSIONS


Though the comprehensive obesity intervention didn't improve the overall dietary diversity per day, the positive intervention effects were observed on breakfast foods and some foods' consumption.",2020,"Additionally, CNP group had greater increases in cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions as compared with the control group.","['younger children', '4846 children aged 7-13 years', '38 primary schools']","['comprehensive childhood obesity interventions', 'childhood obesity interventions', 'comprehensive intervention', 'Nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention including both NE and PA (CNP', 'CNP']","['Dietary Diversity Score (DDS9 and DDS28', 'FVS of dietary scores', 'dietary diversity', 'Food Variety Score ', 'cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions', 'FVS of overall diet', 'overall dietary diversity']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]","[{'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1511518', 'cui_str': 'Copy Number Polymorphisms'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0236026', 'cui_str': 'Fetal valproate syndrome'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",4846.0,0.0989589,"Additionally, CNP group had greater increases in cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions as compared with the control group.","[{'ForeName': 'Haiquan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing, China.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Ecker', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Songming', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Chinese Nutrition Society, Beijing, China.'}, {'ForeName': 'Ailing', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Tingyu', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Chongqing Children's Hospital, Chongqing, China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Harbin Medical University, Harbin, China.'}, {'ForeName': 'Guifa', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Public Health, Shandong University, Jinan, China.'}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Guangzhou Center for Disease Control and Prevention, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute of Child and Adolescent Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Junmao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing, China.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing, China.'}]",PloS one,['10.1371/journal.pone.0235951']
1465,32679757,Characterizing the Heart Rate Response to the 4 × 4 Interval Exercise Protocol.,"High intensity interval training is frequently implemented using the 4 × 4 protocol where four 4-min bouts are performed at heart rate (HR) between 85 and 95% HR max. This study identified the HR and power output response to the 4 × 4 protocol in 39 active men and women (age and VO 2  max = 26.0 ± 6.1 years and 37.0 ± 5.4 mL/kg/min). Initially, participants completed incremental cycling to assess VO 2  max, HR max, and peak power output (PPO). They subsequently completed the 4 × 4 protocol, during which HR and power output were monitored. Data showed that 12.9 ± 0.4 min of 16 min were spent between 85 and 95% HR max, with time spent significantly lower in interval 1 (2.7 ± 0.6 min) versus intervals 2-4 (3.4 ± 0.4 min, 3.4 ± 0.3 min, and 3.5 ± 0.3 min,  d  = 2.4-2.7). Power output was highest in interval 1 (75% PPO) and significantly declined in intervals 2-4 (63 to 54% PPO,  d  = 0.7-1.0). To enhance time spent between 85 and 95% HR max for persons with higher fitness, we recommend immediate allocation of supramaximal intensities in interval one.",2020,"Power output was highest in interval 1 (75% PPO) and significantly declined in intervals 2-4 (63 to 54% PPO,  d  = 0.7-1.0).",['39 active men and women (age and VO 2  max = 26.0 ± 6.1 years and 37.0 ± 5.4 mL/kg/min'],['High intensity interval training'],"['VO 2  max, HR max, and peak power output (PPO', 'Power output', 'Heart Rate Response']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0032956', 'cui_str': 'Preferred Provider Organization'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}]",,0.0733088,"Power output was highest in interval 1 (75% PPO) and significantly declined in intervals 2-4 (63 to 54% PPO,  d  = 0.7-1.0).","[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Acala', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, CA 92096-0001, USA.'}, {'ForeName': 'Devyn', 'Initials': 'D', 'LastName': 'Roche-Willis', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, CA 92096-0001, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Astorino', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, CA 92096-0001, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17145103']
1466,32679839,Effect of Viewing Video Representation of the Urban Environment and Forest Environment on Mood and Level of Procrastination.,"A common problem among students is the problem of delaying important work activities, which is conceptualized as procrastination. Since procrastination can cause considerable costs for society, we would like to find a method to effectively alleviate the symptoms of this conditioning. It has been proven in an earlier study that staying in the forest environment increases vitality and reduces anxiety, and the negative state of these features can be associated with the intensification of procrastination symptoms. Therefore, it is likely that watching a forest video may decrease the probability or intensity of procrastination. To measure the impact of the forest environment on the level of procrastination of the subjects, a randomized experiment was carried out, in which the subjects watched in random order (on different days) one of two 15-min videos: one showing a walk in the forest area and one showing a walk in an urban environment (control). We measured the level of so-called 'fluid procrastination' including three aspects: 'lack of energy to do the work', 'inability to get to work' and 'pessimistic attitude to do the work' with a set of questions the respondents completed before and after the experiment. The results showed that one aspect of fluid procrastination ('pessimistic attitude to do the work') can be effectively lowered by watching a video showing the forest environment. In contrast, watching a video of an urban environment increased the procrastination levels for two other aspects of procrastination ('lack of energy to do the work', 'inability to get to work'). We also measured three other parameters before and after the experiment: mood state, restoration and vitality. Watching the video from forest area raised mood and restoration and watching the video from urban area, decreased mood, vitality and restoration. The study suggests that watching a video showing forest landscapes could be used as an effective remedy for problems related to procrastination among students.",2020,"Watching the video from forest area raised mood and restoration and watching the video from urban area, decreased mood, vitality and restoration.",[],"['Viewing Video Representation of the Urban Environment and Forest Environment', '15-min videos: one showing a walk in the forest area and one showing a walk in an urban environment (control']","['Mood and Level of Procrastination', 'mood state, restoration and vitality']",[],"[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",,0.0230505,"Watching the video from forest area raised mood and restoration and watching the video from urban area, decreased mood, vitality and restoration.","[{'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Bielinis', 'Affiliation': 'Department of Forestry and Forest Ecology, Faculty of Environmental Management and Agriculture, University of Warmia and Mazury, Pl. Łódzki 2, 10-727 Olsztyn, Poland.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Simkin', 'Affiliation': 'Natural Resources Institute Finland, Latokartanonkaari 9, 00790 Helsinki, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Puttonen', 'Affiliation': 'Department of Forest Sciences, University of Helsinki, Latokartanonkaari 7, 00014 Helsinki, Finland.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Tyrväinen', 'Affiliation': 'Natural Resources Institute Finland, Latokartanonkaari 9, 00790 Helsinki, Finland.'}]",International journal of environmental research and public health,['10.3390/ijerph17145109']
1467,32649485,Prevention of Nasal Ala Pressure Injuries With Use of Hydroactive Dressings in Patients With Nasotracheal Intubation of Orthognathic Surgery: A Randomized Controlled Trial.,"PURPOSE


To compare a hydroactive dressing to an adhesive tape standard of care in the prevention of nasal ala pressure injuries associated with nasotracheal intubation during orthognathic surgery.
DESIGN


Randomized controlled trial.
SUBJECTS AND SETTING


The study took place in a tertiary hospital of stomatology in China. Patients undergoing general anesthesia with nasotracheal intubation during orthognathic surgical procedures were invited to participate.
METHODS


Participants were divided into 2 groups: in the experimental group, a hydroactive dressing was applied to the nasal ala before the surgical procedures; the control group received standard prevention with a type of tape. Skin assessments were performed on the wards up to 72 hours after the procedures. Demographic information and potential contributing factors associated the development of nasal ala pressure injuries were collected from patients' electronic medical records. Pressure injury development was staged using National Pressure Injury Advisory staging guidelines. Pressure injury incidence was compared between groups using the χ test and odds ratio.
RESULTS


The sample comprised 450 participants, 225 in each group. The incidence of nasal ala pressure injuries development was 14.222% and 4.444% in the 2 groups, respectively (P = .000). The odds ratio was 3.565 (95% confidence interval, 1.707-7.443).
CONCLUSIONS


The study findings indicate that the incidence of pressure injuries of nasal ala skin protected by hydroactive dressings was lower than the standard preventive method. Hydroactive dressings should be considered as a prevention method to reduce device-related skin injuries associated with nasotracheal intubation.",2020,"The odds ratio was 3.565 (95% confidence interval, 1.707-7.443).
","['Patients With Nasotracheal Intubation of Orthognathic Surgery', ""patients' electronic medical records"", '450 participants, 225 in each group', 'tertiary hospital of stomatology in China', 'Patients undergoing general anesthesia with nasotracheal intubation during orthognathic surgical procedures were invited to participate', 'Participants', 'nasal ala pressure injuries associated with nasotracheal intubation during orthognathic surgery']","['hydroactive dressing was applied to the nasal ala before the surgical procedures; the control group received standard prevention with a type of tape', 'hydroactive dressing', 'Hydroactive Dressings']","['Pressure injury incidence', 'incidence of nasal ala pressure injuries development']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C2717941', 'cui_str': 'Orthognathic Surgical Procedures'}, {'cui': 'C0458563', 'cui_str': 'Alar structure'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0458563', 'cui_str': 'Alar structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0458563', 'cui_str': 'Alar structure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",450.0,0.0218455,"The odds ratio was 3.565 (95% confidence interval, 1.707-7.443).
","[{'ForeName': 'Guoyong', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Guoyong Yang, MSN, RN, CNOR, PACU, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China. Chunyan Gao, BSN, RN, CNOR, Operating Room, Peking University School and Hospital of Stomatology, Beijing, China. Juan Cai, BSN, RN, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': ''}]","Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society",['10.1097/WON.0000000000000675']
1468,32652544,Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2).,"BACKGROUND


Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic.
OBJECTIVES


To report the 3-year efficacy of CZP in plaque psoriasis, pooled from the CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) phase III trials.
METHODS


Adults with moderate-to-severe psoriasis for ≥ 6 months were randomized 2 : 2 : 1 to CZP 200 mg, CZP 400 mg or placebo, every 2 weeks (Q2W) for up to 48 weeks. Patients entering the open-label period (weeks 48-144) from double-blinded CZP initially received CZP 200 mg Q2W. Patients not achieving ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 16 entered an open-label CZP 400 mg Q2W escape arm (weeks 16-144). Dose adjustments based on PASI response were permitted during open-label treatment. Outcomes included PASI 75, PASI 90 and Physician's Global Assessment (PGA) 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology).
RESULTS


In total, 186 patients were randomized to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. At week 48, PASI 75/90 was achieved by 72·7%/51·3% of patients randomized to CZP 200 mg and 84·4%/62·7% randomized to CZP 400 mg. Patients entering the open-label period at week 48, from blinded treatment, received CZP 200 mg Q2W. At week 144, PASI 75/90 was achieved by 70·6%/48·7% patients randomized to CZP 200 mg and 72·9%/42·7% randomized to CZP 400 mg. At week 16, 72 placebo-randomized patients entered the CZP 400 mg Q2W escape arm; 75.7%/58.5% achieved PASI 75/90 at week 144.
CONCLUSIONS


Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W.",2020,"At Week 48, PASI 75/90 was achieved by 72.7%/51.3% CZP 200 mg-randomised and 84.4%/62.7% CZP 400 mg-randomised patients.","['Plaque Psoriasis', 'Adults with moderate to severe PSO for ≥6 months', '186 patients']","['CZP 400 mg Q2W', 'Certolizumab Pegol', 'CZP 200 mg Q2W', 'CZP', 'Certolizumab pegol (CZP', 'CZP 200 mg Q2W. Patients not achieving Week 16 PASI 50 entered an open-label CZP 400 mg Q2W escape', 'CZP 200 mg, CZP 400 mg, placebo']","['PASI\xa075, PASI\xa090, and PGA 0/1 responder rates', 'Psoriasis Area and Severity Index (PASI) response', 'durable efficacy']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",186.0,0.321058,"At Week 48, PASI 75/90 was achieved by 72.7%/51.3% CZP 200 mg-randomised and 84.4%/62.7% CZP 400 mg-randomised patients.","[{'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology and Saint Louis University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Centre de Recherche Dermatologique du Québec Métropolitain, Québec, QC, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boehnlein', 'Affiliation': 'UCB Pharma, Monheim, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ecoffet', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19393']
1469,32657494,Reducing loneliness among people with substance use disorders: Feasibility of 'Groups for Belonging'.,"INTRODUCTION AND AIMS


Although loneliness is common among people with substance use disorders, few interventions to reduce loneliness have been developed for this population. This study aimed to determine the feasibility of delivering a six-session group-based intervention, 'Groups for Belonging', that builds social group connectedness.
DESIGN AND METHODS


Participants were 41 individuals accessing residential substance use treatment services. The primary aims of the present study were to determine indicators of feasibility of Groups for Belonging; namely, demand (recruitment, attendance and retention) for and acceptability (program adherence and participant satisfaction) of the Groups for Belonging program in residential substance use treatment settings.
RESULTS


Over half of the people attending the services were interested in participating in Groups for Belonging. Of 41 participants who commenced the program, 20 participants completed the program per protocol. In terms of acceptability, the average number of sessions attended was 3.7 (SD = 1.76, range 1-6). Program adherence was 99.3% and overall satisfaction with the program was high, with 95% of participants reporting they enjoyed Groups for Belonging.
DISCUSSION AND CONCLUSIONS


The Groups for Belonging program may be feasible for delivery in residential substance use treatment services. Findings from this study suggest that an adequately powered replication study is warranted.",2020,"Program adherence was 99.3% and overall satisfaction with the program was high, with 95% of participants reporting they enjoyed Groups for Belonging.
","['Participants were 41 individuals accessing residential substance use treatment services', '41 participants who commenced the program, 20 participants completed the program per protocol', 'people with substance use disorders']",[],"['overall satisfaction', 'Program adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0150359', 'cui_str': 'Substance use therapy'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0750536,"Program adherence was 99.3% and overall satisfaction with the program was high, with 95% of participants reporting they enjoyed Groups for Belonging.
","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Ingram', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Haslam', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Owen J', 'Initials': 'OJ', 'LastName': ""O'Neil"", 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Deane', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Baker', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Genevieve A', 'Initials': 'GA', 'LastName': 'Dingle', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Australia.'}]",Drug and alcohol review,['10.1111/dar.13121']
1470,32654156,Neuropathy symptom and change: Inotersen treatment of hereditary transthyretin amyloidosis.,"INTRODUCTION


Hereditary transthyretin-mediated amyloidosis (hATTR) manifests as multisystem dysfunction, including progressive polyneuropathy. Inotersen, an antisense oligonucleotide, improved the course of neuropathic impairment in patients with hATTR in the pivotal NEURO-TTR study (NCT01737398). To determine inotersen's impact on symptoms and patients' neuropathy experience, we performed a post hoc analysis of the Neuropathy Symptoms and Change (NSC) score.
METHODS


Stage 1 or 2 hATTR patients were randomized to receive weekly subcutaneous inotersen or placebo for 65 weeks. NSC score was assessed at baseline and 35 and 66 weeks.
RESULTS


At 66 weeks, inotersen-treated patients had symptom stabilization as compared with worsening in patients receiving placebo, based on total NSC score. There were also improvements in the subdomains of muscle weakness, sensory, pain, and autonomic symptoms, and for various individual items.
DISCUSSION


Inotersen treatment stabilized neuropathy symptoms, including autonomic symptoms, in patients with hATTR according to NSC score. Thus, the NSC may be an effective measure to assess neuropathy progression and patients' neuropathy experience in clinical practice.",2020,"At 66 weeks, inotersen-treated patients experienced symptom stabilization versus worsening in patients receiving placebo in NSC total score; the subdomains of muscle weakness, sensory, pain, and autonomic symptoms; and for various individual items.
","['patients with hATTR based on the NSC score', 'Stage 1/2 hATTR patients', 'Hereditary Transthyretin Amyloidosis']","['subcutaneous inotersen or placebo', 'placebo']","['NSC score', 'Neuropathy Symptoms and Change (NSC) score', 'muscle weakness, sensory, pain, and autonomic symptoms', 'neuropathic impairment', 'Neuropathy Symptom and Change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C2751492', 'cui_str': 'Hereditary Amyloidosis, Transthyretin-Related'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4731850', 'cui_str': 'inotersen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0554384,"At 66 weeks, inotersen-treated patients experienced symptom stabilization versus worsening in patients receiving placebo in NSC total score; the subdomains of muscle weakness, sensory, pain, and autonomic symptoms; and for various individual items.
","[{'ForeName': 'P James B', 'Initials': 'PJB', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Coelho', 'Affiliation': 'Department of Neurosciences, Centro Hospitalar do Porto, Porto, Portugal.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Waddington Cruz', 'Affiliation': 'Department of Neurology, Federal University of Rio de Janeiro, University Hospital, Rio de Janeiro, Brazil.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brannagan', 'Affiliation': 'Department of Peripheral Neuropathy, Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Khella', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Berk', 'Affiliation': 'Department of Medicine, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Polydefkis', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Kincaid', 'Affiliation': 'Department of Neurology, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Wiesman', 'Affiliation': 'Department of Neurology, New York University, New York, New York, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Litchy', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mauermann', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Ackermann', 'Affiliation': 'Otonomy, Inc, San Diego, California, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Shiangtung W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}]",Muscle & nerve,['10.1002/mus.27023']
1471,32654212,mNIS+7 and lower limb function in inotersen treatment of hereditary transthyretin-mediated amyloidosis.,"INTRODUCTION


Inotersen, an antisense oligonucleotide inhibitor of transthyretin (TTR) protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score (NIS) +7 neurophysiologic tests (mNIS+7) in patients with hereditary TTR-mediated amyloidosis (hATTR) with polyneuropathy. This analysis assessed the mNIS+7 components by anatomic location and the lower limb function (LLF) test.
METHODS


Adults with hATTR in the NEURO-TTR trial (NCT01737398) were randomly assigned to receive weekly doses of subcutaneous inotersen 300 mg or placebo for 65 weeks. The mNIS+7 and LLF were assessed at 35 and 66 weeks.
RESULTS


All major mNIS+7 components (muscle weakness, muscle stretch reflexes, sensation) and the LLF showed significant efficacy in patients receiving inotersen versus placebo; however, NIS-reflexes (upper limb), touch pressure (upper and lower limbs), and heart rate during deep breathing did not show significant effects.
DISCUSSION


The results of this analysis reinforce the beneficial effect of inotersen on slowing neuropathy progression in patients with hATTR polyneuropathy.",2020,"Inotersen, an antisense oligonucleotide inhibitor of TTR protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score +7 neurophysiologic tests (mNIS+7) in patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy.","['Adults with hATTR', 'patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy', 'patients with hATTR polyneuropathy']","['subcutaneous inotersen 300 mg or placebo', 'placebo']","['All major mNIS+7 components (muscle weakness, muscle stretch reflexes, sensation', 'mNIS+7 and LLF', 'Mnis+7 And Lower Limb Function', 'NIS-reflexes (upper limb), touch pressure (upper and lower limbs), and heart rate deep breathing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002726', 'cui_str': 'Amyloidosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0206247', 'cui_str': 'Polyneuropathy in amyloidosis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4731850', 'cui_str': 'inotersen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0407178', 'cui_str': 'Stretching of muscle'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1504824', 'cui_str': 'SLC5A5 protein, human'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}]",,0.124471,"Inotersen, an antisense oligonucleotide inhibitor of TTR protein production, demonstrated significant benefit versus placebo in the modified Neuropathy Impairment Score +7 neurophysiologic tests (mNIS+7) in patients with hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy.","[{'ForeName': 'P James B', 'Initials': 'PJB', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Kincaid', 'Affiliation': 'Department of Neurology, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Janice F', 'Initials': 'JF', 'LastName': 'Wiesman', 'Affiliation': 'Department of Neurology, New York University, New York, New York, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Polydefkis', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Litchy', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Mauermann', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Ackermann', 'Affiliation': 'Otonomy, Inc., San Diego, California, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Guthrie', 'Affiliation': 'Aurora Bio, San Francisco, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Akcea Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Shiangtung W', 'Initials': 'SW', 'LastName': 'Jung', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals, Inc., Carlsbad, California, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Dyck', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}]",Muscle & nerve,['10.1002/mus.27022']
1472,32665529,Abaloparatide followed by alendronate in women ≥80 years with osteoporosis: post hoc analysis of ACTIVExtend.,"OBJECTIVE


Fracture risk increases with age, but few studies focus on persons ≥80 years. In the ACTIVE trial, treatment with abaloparatide for 18 months reduced osteoporotic fracture risk and increased bone mineral density. These effects were maintained with 24 months alendronate treatment in ACTIVExtend. We postulated that similar improvements in bone mineral density and safety would be demonstrated in women ≥80 years.
METHODS


Post hoc analyses of bone mineral density and fracture incidence in women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend.
RESULTS


In total, 56 women aged ≥80 years at ACTIVE baseline entered the ACTIVExtend study; 46 of these completed the study. Mean age was 83.3 years; other baseline characteristics were similar. At the end of ACTIVE, bone mineral density increased at all sites for abaloparatide versus placebo. Bone mineral density increased in parallel in both groups during alendronate therapy (19 to 43 months) in ACTIVExtend. At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine, 5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip, and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck. Fracture incidence was low and did not differ significantly between groups. Sequential treatment with abaloparatide followed by alendronate was well tolerated; the proportion of participants reporting adverse events was similar between groups.
CONCLUSIONS


Sequential treatment with abaloparatide followed by alendronate (43 months follow-up) in this small subgroup of ACTIVExtend participants suggests abaloparatide is well tolerated and effective in women aged ≥80 years. : Video Summary:http://links.lww.com/MENO/A618.",2020,"At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine, 5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip, and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck.","['56 women aged ≥80 years at ACTIVE baseline entered the ACTIVExtend study; 46 of these completed the study', 'persons ≥80 years', 'women ≥80 years', 'women ≥80 years with osteoporosis', 'women with osteoporosis at high risk of fracture ≥80 years from ACTIVExtend', 'women aged ≥80 years']","['Abaloparatide followed by alendronate', 'alendronate', ' Video Summary:http://links.lww.com/MENO/A618', 'placebo/alendronate', 'placebo']","['bone mineral density', 'bone mineral density and safety', 'tolerated; the proportion of participants reporting adverse events', 'Bone mineral density', 'osteoporotic fracture risk and increased bone mineral density', 'Fracture incidence', 'bone mineral density and fracture incidence']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0029464', 'cui_str': 'Osteosclerosis'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",56.0,0.236803,"At month 43, mean percent change in bone mineral density from baseline was 17.2% abaloparatide/alendronate versus 8.6% placebo/alendronate (P < 0.0001) at the lumbar spine, 5.3% abaloparatide/alendronate versus 3.0% placebo/alendronate (P = 0.024) at the total hip, and 4.6% abaloparatide/alendronate versus 3.1% placebo/alendronate (P = 0.044) at the femoral neck.","[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Lorraine A', 'Initials': 'LA', 'LastName': 'Fitzpatrick', 'Affiliation': 'Radius Health, Inc., Waltham, MA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Mitlak', 'Affiliation': 'Radius Health, Inc., Waltham, MA.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Radius Health, Inc., Waltham, MA.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Harvey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Deal', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McClung', 'Affiliation': 'Oregon Osteoporosis Center, Portland, OR.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001593']
1473,32663055,Exploring the Impact of Mindfulness on False-Memory Susceptibility.,"Wilson, Mickes, Stolarz-Fantino, Evrard, and Fantino (2015) presented data from three well-powered experiments suggesting that a brief mindfulness induction can increase false-memory susceptibility. However, we had concerns about some of the methodology, including whether mind wandering is the best control condition for brief mindfulness inductions. Here, we report the findings from a preregistered double-blind randomized controlled trial designed to replicate and extend Wilson et al.'s findings. Participants ( N  = 287) underwent 15-min mindfulness or mind-wandering inductions or completed a join-the-dots task before being presented with lists of words related to nonpresented critical lures. This was followed by free-recall and recognition tasks. There was no evidence for an effect of state of mind on correct or false recall or recognition. Furthermore, manipulation checks revealed that mindfulness and mind-wandering inductions activated overlapping states of mind. Exploratory analyses provided some support for mindfulness increasing false memory, but it appears that mind wandering may not be the right control for brief mindfulness research.",2020,There was no evidence for an effect of state of mind on correct or false recall or recognition.,['Participants ( N  = 287) underwent'],['15-min mindfulness or mind-wandering inductions or completed a join-the-dots task before being presented with lists of words related to nonpresented critical lures'],"['false-memory susceptibility', 'False-Memory Susceptibility']","[{'cui': 'C4517682', 'cui_str': '287'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0233569', 'cui_str': 'Wandering'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]","[{'cui': 'C0561845', 'cui_str': 'False memories'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",,0.0455014,There was no evidence for an effect of state of mind on correct or false recall or recognition.,"[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sherman', 'Affiliation': 'School of Psychology, Keele University.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Grange', 'Affiliation': 'School of Psychology, Keele University.'}]",Psychological science,['10.1177/0956797620929302']
1474,32664369,Countering Vaccine Hesitancy among Pregnant Women in England: The Case of Boostrix-IPV.,"This study explored the effects of message framing on vaccine hesitancy for the antenatal whooping cough vaccine. The study also assessed whether the Theory of Planned Behaviour (TPB) constructs had any explanatory utility for vaccine intentions and behaviours in pregnant women. A between-subjects, cross-sectional design was employed. Participants ( n  = 282) were women who were pregnant (mean = 28 weeks, SD = 7.0), living in England and between 18 and 44 years of age. A self-report web-based survey was used to collect data. Participants were randomly assigned to read either (i) disease risk, (ii) myth busting, or (iii) control information before answering questions based on the TPB. No significant effects of message framing were found. Attitudes (Beta = 0.699;  p  < 0.001) and subjective norms (Beta = 0.262,  p  < 0.001) significantly predicted intention to vaccinate but perceived behavioural control did not. The TPB constructs accounted for 86% and 36% of the variance in vaccine intention and vaccine history respectively. Disease risk information did not influence vaccine acceptability in this sample of English pregnant women. The study offered preliminary evidence that interventions targeting constructs from the TPB may promote vaccine acceptability among pregnant women.",2020,No significant effects of message framing were found.,"['Participants ( n  = 282) were women who were pregnant (mean = 28 weeks, SD = 7.0), living in England and between 18 and 44 years of age', 'Pregnant Women in England', 'English pregnant women', 'pregnant women']","['read either (i) disease risk, (ii) myth busting, or (iii) control information before answering questions based on the TPB']","['behavioural control', 'vaccine acceptability', 'Attitudes']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",282.0,0.10224,No significant effects of message framing were found.,"[{'ForeName': 'Mairead', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Laura A V', 'Initials': 'LAV', 'LastName': 'Marlow', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London WC1E 6BT, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London WC1E 6BT, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17144984']
1475,32664375,Long-Term Influence of the Practice of Physical Activity on the Self-Perceived Quality of Life of Women with Breast Cancer: A Randomized Controlled Trial.,"Background:  There is still no consensus on the most suitable interventions for exercise practice in breast cancer survivors. Therefore, the aim of this study was to evaluate the effect of a two-year physical activity intervention (strength, aqua fitness and aerobic exercise programs) on the self-perceived quality of life and physical functionality of female breast cancer survivors.  Methods:  A randomized, controlled, experimental trial with a sample of 316 women (63 ± 7 years), who had been diagnosed with breast cancer. The evaluations were performed using the Rikli & Jones Senior Fitness Test, and the Short Form 12 Health Survey (SF-12).  Results:  The participants in the strength program showed statistically significant improvements in all the items of the SF-12. The aqua fitness program obtained significant improvements in Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12. The participants in the aerobic program showed a progressive deterioration of Vitality and Mental Health.  Conclusion:  When assigning breast cancer survivors to an exercise program, the preferential or predominant activity should include strength exercises. On the other hand, as the second choice, those patients with particularly low levels of Vitality or Physical Limitations will show greater improvement with an aqua fitness program.",2020,"The aqua fitness program obtained significant improvements in Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12.","['breast cancer survivors', 'Women with Breast Cancer', 'female breast cancer survivors', '316 women (63 ± 7 years), who had been diagnosed with breast cancer']","['two-year physical activity intervention (strength, aqua fitness and aerobic exercise programs']","['Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12', 'self-perceived quality of life and physical functionality', 'progressive deterioration of Vitality and Mental Health', 'Self-Perceived Quality of Life', 'SF-12']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",316.0,0.0362931,"The aqua fitness program obtained significant improvements in Physical Functioning and Limitations, Pain and Emotional Limitations, General Health, Vitality, Social Functioning and the physical and mental components of the SF-12.","[{'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'García-Soidán', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, Campus a Xunqueira, s/n. 36005 Pontevedra, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Pérez-Ribao', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, Campus a Xunqueira, s/n. 36005 Pontevedra, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Leirós-Rodríguez', 'Affiliation': 'Faculty of Physical Therapy, University of Vigo, Campus a Xunqueira, s/n. 36005 Pontevedra, Spain.'}, {'ForeName': 'Anxela', 'Initials': 'A', 'LastName': 'Soto-Rodríguez', 'Affiliation': 'Health Service from Galicia (SERGAS), Galician Health Services-Ourense Hospital, 32005 Ourense, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17144986']
1476,32674419,Impact of an Educational Program on Behavioral Changes toward Environmental Health among Laotian Students.,"This study evaluates the effect of an integrated health care educational program on several behavioral changes related to environmental health among Laotian students. Students in the experimental group received education concerning environmental health-related issues, including air pollution and chemical exposure. Analyses of covariance (ANCOVA) and paired  t -tests were conducted for the statistical analysis of the pre- and post-survey scores. The post-test scores of the experimental group regarding their risk perception and information-seeking behaviors towards air pollution and chemical exposure were higher than those of the control group after controlling for the pre-test scores. Moreover, in the experimental group, the girls' risk perception scores significantly increased after receiving the education, which was not observed in the control group. The risk perception score among non-drinking students also significantly increased after the program. These results indicate that the education program effectively enhanced the students' risk perception, especially that of girls and nondelinquent students.",2020,The post-test scores of the experimental group regarding their risk perception and information-seeking behaviors towards air pollution and chemical exposure were higher than those of the control group after controlling for the pre-test scores.,"['Laotian Students', 'Laotian students']","['education concerning environmental health-related issues, including air pollution and chemical exposure', 'Educational Program', 'integrated health care educational program']","['risk perception score', 'risk perception and information-seeking behaviors towards air pollution and chemical exposure', ""students' risk perception"", ""girls' risk perception scores"", 'Behavioral Changes toward Environmental Health']","[{'cui': 'C0023033', 'cui_str': 'Lao language'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014413', 'cui_str': 'Health, Environmental'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0678803', 'cui_str': 'Chemical exposure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0596775', 'cui_str': 'Information Seeking Behavior'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0678803', 'cui_str': 'Chemical exposure'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0014413', 'cui_str': 'Health, Environmental'}]",,0.0119297,The post-test scores of the experimental group regarding their risk perception and information-seeking behaviors towards air pollution and chemical exposure were higher than those of the control group after controlling for the pre-test scores.,"[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Department of Occupational and Environmental Medicine, College of Medicine, Ewha Womans University, Seoul 07804, Korea.'}, {'ForeName': 'Harris Hyun-Soo', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': 'Department of Sociology, College of Social Sciences, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Eun Mee', 'Initials': 'EM', 'LastName': 'Kim', 'Affiliation': 'Department of International Studies, Graduate School of International Studies, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Yookyung', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Division of Kinesiology & Sports Studies, College of Science and Industry Convergence, Ewha Womans University, Seoul 03760, Korea.'}, {'ForeName': 'Eunhee', 'Initials': 'E', 'LastName': 'Ha', 'Affiliation': 'Department of Occupational and Environmental Medicine, College of Medicine, Ewha Womans University, Seoul 07804, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17145055']
1477,32538148,An acute rise of plasma Na +  concentration associates with syndecan-1 shedding during hemodialysis.,"Endothelial dysfunction (ED) contributes to the high incidence of cardiovascular events in patients undergoing hemodialysis. Syndecan-1 in the endothelial glycocalyx can be shed into the circulation, serving as a biomarker for ED. As Na +  is a trigger for glycocalyx shedding, we now tested whether hemodialysis, with higher dialysate Na +  concentrations, is associated with more syndecan-1 shedding compared with standard hemodialysis (SHD). In this crossover study in 29 patients, plasma syndecan-1 was repeatedly measured during SHD and during Hemocontrol hemodialysis (HHD), which is characterized by initially higher dialysate and plasma Na +  levels. Courses of syndecan-1 were compared with linear mixed models. Syndecan-1 shedding was assessed by area under the curve analysis. Plasma Na +  increased early after the start of SHD and HHD, with higher values during HHD (30 min: 142.3 vs. 139.9 mM,  P  < 0.001). Syndecan-1 increased significantly during both conditions, but the percent change was higher (42.9% vs. 19.5%) and occurred earlier (120 vs. 180 min) during HHD. Syndecan-1 levels were significantly higher at 120 min during HHD compared with SHD ( P  < 0.05). Overall, syndecan-1 shedding was higher during HHD compared with SHD (means: 40.4 vs. 19.0 arbitrary units,  P  = 0.06). Lower predialysis plasma Na +  and osmolality were associated with greater intradialytic increases in syndecan-1 levels (both groups,  P  = 0.001). The rise in plasma syndecan-1 levels was more pronounced and occurred earlier during hemodialysis with higher plasma Na +  levels. Although we cannot prove that the rise in plasma syndecan-1 originates from the endothelial glycocalyx, our findings are compatible with Na + -driven endothelial glycocalyx-derived syndecan-1 shedding.",2020,The rise in plasma syndecan-1 levels was more pronounced and occurred earlier during hemodialysis with higher plasma Na +  levels.,"['29 patients, plasma syndecan-1 was repeatedly measured during SHD and during Hemocontrol hemodialysis (HHD), which is characterized by initially higher dialysate and plasma Na +  levels', 'patients undergoing hemodialysis']",[],"['Endothelial dysfunction (ED', 'Lower predialysis plasma Na +  and osmolality', 'syndecan-1 levels', 'plasma syndecan-1 levels', 'syndecan-1 shedding', 'Plasma Na ', 'Syndecan-1 shedding', 'Syndecan-1 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",[],"[{'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",29.0,0.028535,The rise in plasma syndecan-1 levels was more pronounced and occurred earlier during hemodialysis with higher plasma Na +  levels.,"[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Koch', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Nienke M A', 'Initials': 'NMA', 'LastName': 'Idzerda', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Esmée M', 'Initials': 'EM', 'LastName': 'Ettema', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Kuipers', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dam', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'van den Born', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Casper F M', 'Initials': 'CFM', 'LastName': 'Franssen', 'Affiliation': 'Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",American journal of physiology. Renal physiology,['10.1152/ajprenal.00005.2020']
1478,32679040,"Standard gastroenterologist versus multidisciplinary treatment for functional gastrointestinal disorders (MANTRA): an open-label, single-centre, randomised controlled trial.","BACKGROUND


Functional gastrointestinal disorders are common and costly to the health-care system. Most specialist care is provided by a gastroenterologist, but only a minority of patients have improvement in symptoms. Although they have proven to be effective, psychological, behavioural, and dietary therapies are not provided routinely. We aimed to compare the outcome of gastroenterologist-only standard care with multidisciplinary care.
METHODS


In an open-label, single-centre, pragmatic trial, consecutive new referrals of eligible patients aged 18-80 years with Rome IV criteria-defined functional gastrointestinal disorders were randomly assigned (1:2) to receive gastroenterologist-only standard care or multidisciplinary clinic care. The multidisciplinary clinic included gastroenterologists, dietitians, gut-focused hypnotherapists, psychiatrists, and behavioural (biofeedback) physiotherapists. Randomisation was stratified by Rome IV disorder and whether referred from gastroenterology or colorectal clinic. Outcomes were assessed at clinic discharge or 9 months after the initial visit. The primary outcome was a score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing global symptom improvement. Modified intention-to-treat analysis included all patients who attended at least one clinic visit and who had answered the primary outcome question. This study is registered with ClinicalTrials.gov, NCT03078634.
FINDINGS


Between March 16, 2017, and May 10, 2018, 1632 patients referred to the hospital gastrointestinal clinics were screened, of whom 442 were eligible for a screening telephone call and 188 were randomly assigned to receive either standard care (n=65) or multidisciplinary care (n=123). 144 patients formed the modified intention-to-treat analysis (n=46 in the standard-care group and n=98 in the multidisciplinary-care group), 90 (63%) of whom were women. 61 (62%) of 98 patients in the multidisciplinary-care group patients saw allied clinicians. 26 (57%) patients in the standard-care group and 82 (84%) patients in the multidisciplinary-care group had global symptom improvement (risk ratio 1·50 [95% CI 1·13-1·93]; p=0·00045). 29 (63%) patients in the standard-care group and 81 (83%) patients in the multidisciplinary-care group had adequate relief of symptoms in the past 7 days (p=0·010). Patients in the multidisciplinary-care group were more likely to experience a 50% or higher reduction in all Gastrointestinal Symptom Severity Index symptom clusters than were patients in the standard-care group. Of the patients with irritable bowel syndrome, a 50-point or higher reduction in IBS-SSS occurred in 10 (38%) of 26 patients in the standard care group compared with 39 (66%) of 59 patients in the multidisciplinary-care group (p=0·017). Of the patients with functional dyspepsia, a 50% reduction in the Nepean Dyspepsia Index was noted in three (11%) of 11 patients in the standard-care group and in 13 (46%) of 28 in the multidisciplinary-care group (p=0·47). After treatment, the median HADS scores were higher in the standard-care group than in the multidisciplinary-care group (13 [8-20] vs 10 [6-16]; p=0·096) and the median EQ-5D-5L quality of life visual analogue scale was lower in the standard-care group compared with the multidisciplinary-care group (70 [IQR 50-80] vs 75 [65-85]; p=0·0087). The eight SF-36 scales did not differ between the groups at discharge. After treatment, median Somatic Symptom Scale-8 score was higher in the standard-care group than in the multidisciplinary-care group (10 [IQR 7-7] vs 9 [5-13]; p=0·082). Cost per successful outcome was higher in the standard-care group than the multidisciplinary-care group.
INTERPRETATION


Integrated multidisciplinary clinical care appears to be superior to gastroenterologist-only care in relation to symptoms, specific functional disorders, psychological state, quality of life, and cost of care for the treatment of functional gastrointestinal disorders. Consideration should be given to providing multidisciplinary care for patients with a functional gastrointestinal disorder.
FUNDING


None.",2020,"After treatment, the median HADS scores were higher in the standard-care group than in the multidisciplinary-care group (13 [8-20] vs 10 [6-16]; p=0·096) and the median EQ-5D-5L quality of life visual analogue scale was lower in the standard-care group compared with the multidisciplinary-care group (70 [IQR 50-80] vs 75 [65-85]; p=0·0087).","['patients with irritable bowel syndrome', 'patients who attended at least one clinic visit and who had answered the primary outcome question', '144 patients formed the modified intention-to-treat analysis (n=46 in the standard-care group and n=98 in the multidisciplinary-care group), 90 (63%) of whom were women', 'patients with a functional gastrointestinal disorder', '61 (62%) of 98 patients in the multidisciplinary-care group patients saw allied clinicians', 'Between March 16, 2017, and May 10, 2018, 1632 patients referred to the hospital gastrointestinal clinics were screened, of whom 442 were eligible for a screening telephone call and 188', 'eligible patients aged 18-80 years with Rome IV criteria-defined functional gastrointestinal disorders', 'functional gastrointestinal disorders (MANTRA']","['gastroenterologist-only standard care or multidisciplinary clinic care', 'standard care (n=65) or multidisciplinary care', 'gastroenterologist-only standard care with multidisciplinary care', 'Standard gastroenterologist versus multidisciplinary treatment']","['global symptom improvement (risk ratio 1·50', 'IBS-SSS', 'median EQ-5D-5L quality of life visual analogue scale', 'Gastrointestinal Symptom Severity Index symptom clusters', 'Cost per successful outcome', 'eight SF-36 scales', 'median Somatic Symptom Scale-8 score', 'Nepean Dyspepsia Index', 'adequate relief of symptoms', 'score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing global symptom improvement', 'median HADS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0559031', 'cui_str': 'Functional disorder of gastrointestinal tract'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0259901', 'cui_str': 'Gastroenterologist'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",1632.0,0.109724,"After treatment, the median HADS scores were higher in the standard-care group than in the multidisciplinary-care group (13 [8-20] vs 10 [6-16]; p=0·096) and the median EQ-5D-5L quality of life visual analogue scale was lower in the standard-care group compared with the multidisciplinary-care group (70 [IQR 50-80] vs 75 [65-85]; p=0·0087).","[{'ForeName': 'Chamara', 'Initials': 'C', 'LastName': 'Basnayake', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kamm', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia. Electronic address: mkamm@unimelb.edu.au.""}, {'ForeName': 'Annalise', 'Initials': 'A', 'LastName': 'Stanley', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': ""Wilson-O'Brien"", 'Affiliation': ""Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Burrell', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Lees-Trinca', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Khera', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Kantidakis', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wong', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Fox', 'Affiliation': 'Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Talley', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'School of Public Health and Preventative Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Salzberg', 'Affiliation': ""Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Thompson', 'Affiliation': ""Department of Gastroenterology, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine St Vincent's Hospital, University of Melbourne, Melbourne, VIC, Australia.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30215-6']
1479,32682174,The renin secretion profile under the influence of sleep deprivation and the neuropeptides CRH and GHRH.,"It is already known that during normal sleep plasma renin activity (PRA) shows oscillations with decreases during rapid-eye-movement (REM) sleep and increases during non-REM (NREM) sleep. We also know that renin correlates positively with slow-wave sleep (SWS). Sleep deprivation is known to enhance significantly SWS and slow wave activity (SWA, known as δ power). Based on these findings we addressed the question whether and to which extent sleep deprivation may affect the synchronization found between PRA and REM sleep during normal sleep and whether this synchronization is affected by other sleep regulating factors. To investigate these questions we compared sleep EEG and sleep-related free renin levels in 48 normal women and men 19-69 years old between nights before and after 40 h of sleep deprivation. During the recovery night, four bolus injections of either GHRH, CRH or placebo were injected via long catheter around sleep onset. When compared to baseline after each of the treatments SWS, SWA and renin levels increased. The characteristical oscillation profiles of renin during normal sleep were also preserved after sleep deprivation. Similar to normal sleep our data support also a distinct link between nocturnal renin secretion and SWS after sleep deprivation and that independent of the applied treatments.",2020,"When compared to baseline after each of the treatments SWS, SWA and renin levels increased.",['48 normal women and men 19-69 years old between nights before and after 40\u2009h of sleep deprivation'],"['GHRH, CRH or placebo']","['renin correlates positively with slow-wave sleep (SWS', 'SWA and renin levels', 'sleep EEG and sleep-related free renin levels']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0038977', 'cui_str': 'Swahili language'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0200101', 'cui_str': 'Sleep electroencephalogram'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",48.0,0.0236425,"When compared to baseline after each of the treatments SWS, SWA and renin levels increased.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Künzel', 'Affiliation': 'Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Germany; Max-Planck-Institut für Psychiatrie München, Germany. Electronic address: Heike.Kuenzel@med.uni-muenchen.de.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schüssler', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany; Universität Regensburg, Klinik und Poliklinik für Psychiatrie, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yassouridis', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Uhr', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kluge', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany; Universität Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Steiger', 'Affiliation': 'Max-Planck-Institut für Psychiatrie München, Germany.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104799']
1480,32682408,"Evaluation of the impact of breastfeeding support groups in primary health CENTRES in Andalusia, Spain: a study protocol for a cluster randomized controlled trial (GALMA project).","BACKGROUND


In 2003, the World Health Organization recommended exclusive breastfeeding (EB) during the newborn's first 6 months of life and, if possible, during the first 2 years. However, EB rates resist these recommendations. In developed countries, only 1 out of 3 babies is breastfed during its first 6 months of life, and great differences between areas and countries can be observed. Only 35% of the newborns receive breastfeeding at 3-4 months of age. There are diverse strategies described in the literature that have proven their efficiency in improving breastfeeding rates. It has also been proven that professional support is an effective tool to extend any kind of breastfeeding; besides, it has been observed that mother-to-mother support also increases breastfeeding initiation, sustainment, and exclusive duration. The overall aim of the study is to assess the impact of the support groups on the sustainment of exclusive breastfeeding until 6 months after birth.
METHODS/DESIGN


This study is a cluster-random multicentric clinical trial with a control group and an intervention group, without blinding because it is impossible to mask the intervention. A randomization by centres of primary health (clusters) will be carried out. The women allocated to the intervention or control group will be randomized with a simple randomization sampling. The participants' breastfeeding rate will be followed up at the first 10 days, and at 2, 4, and 6 months of their newborn's life.
DISCUSSION


There is a need to assess the impact of mother support groups on exclusive breastfeeding. This study aims to analyse the outcomes related to the support received and to identify what should the structure of these groups be; in other words, to describe factors related to a better breastfeeding experience in order to help women increase breastfeeding rates.
TRIAL REGISTRATION


The trial is prospectively recorded at the ISRCTN registry (Trial ID: ISRCTN17263529 ). Date recorded: 17/06/2020.",2020,"This study aims to analyse the outcomes related to the support received and to identify what should the structure of these groups be; in other words, to describe factors related to a better breastfeeding experience in order to help women increase breastfeeding rates.
","['primary health CENTRES in Andalusia, Spain']",[],['breastfeeding rate'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}]",,0.066185,"This study aims to analyse the outcomes related to the support received and to identify what should the structure of these groups be; in other words, to describe factors related to a better breastfeeding experience in order to help women increase breastfeeding rates.
","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Rodríguez-Gallego', 'Affiliation': 'Virgen del Rocío University Hospital (Seville), Centro Universitario de Enfermería Cruz Roja, University of Seville, Sevilla, Spain.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Leon-Larios', 'Affiliation': 'Nursing Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Sevilla, Spain. fatimaleon@us.es.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Ruiz-Ferrón', 'Affiliation': 'Nursing Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Sevilla, Spain.'}, {'ForeName': 'Maria-de-Las-Mercedes', 'Initials': 'MD', 'LastName': 'Lomas-Campos', 'Affiliation': 'Nursing Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Sevilla, Spain.'}]",BMC public health,['10.1186/s12889-020-09244-w']
1481,32690330,[Effects of including mutual aid groups in the adherence of a continuing care programme of alcohol dependent patients carried out in a Primary Care setting].,"OBJECTIVES


To demonstrate the effects of including mutual aid associations into a continuing care programme for patients with alcohol dependence carried out by Primary Care teams. SITE: Primary Care Teams belonging to the attendance area of the University Hospital 12 de Octubre at Madrid.
PARTICIPANTS


207 participants with alcohol dependence treated in an intensive hospital outpatient-setting programme were included in a continuing care programme carried out by a Primary Care team for a four-year period.
INTERVENTIONS


Patients were randomised into two intervention modalities. The first group was followed up while receiving a treatment modality known as «monitoring recovery» (Group A, n = 97). The other group, in addition to the above-mentioned intervention, attended to a mutual aid association included in the Federation of Alcoholics of the Community of Madrid (FACOMA) in which the programme «Help Yourself-Help Us» was carried out (Group B, n = 112).
MAIN OUTCOMES


Dropout rates on the sessions designed to monitor their recovery from their alcohol dependence and other comorbid medical conditions.
RESULTS


Patients in Group B reached higher rates of therapeutic adherence to the programme (47.9% vs. 14.7%, p < 0.01), as well as for the comorbid medical issues when compared to Group A.
CONCLUSIONS


Including mutual aid associations that carried out the «Help yourself-Help Us» programme for a four-year period improves outcomes related to therapeutic adherence in patients with alcohol dependence attending Primary Care teams.",2020,» programme for a four-year period improves outcomes related to therapeutic adherence in patients with alcohol dependence attending Primary Care teams.,"['207 participants with alcohol dependence treated in an intensive hospital outpatient-setting programme were included in a continuing care programme carried out by a Primary Care team for a four-year period', 'patients with alcohol dependence attending Primary Care teams', 'patients with alcohol dependence carried out by Primary Care teams', 'Primary Care Teams belonging to the attendance area of the University Hospital 12 de Octubre at Madrid']",['SITE'],"['alcohol dependence and other comorbid medical conditions', 'therapeutic adherence']","[{'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}]",207.0,0.0135567,» programme for a four-year period improves outcomes related to therapeutic adherence in patients with alcohol dependence attending Primary Care teams.,"[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rubio', 'Affiliation': 'Servicio de Psiquiatría, Hospital Universitario 12 de Octubre, Madrid, España; Instituto de Investigación 12 de Octubre (I+12), Hospital Universitario 12 de Octubre, Madrid, España; Departamento de Medicina Legal, Psiquiatría y Anatomía, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, España; Red de Trastornos Adictivos (RETIS), Instituto Carlos III, Madrid, España.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Marín', 'Affiliation': 'Servicio de Psiquiatría, Hospital Universitario 12 de Octubre, Madrid, España; Instituto de Investigación 12 de Octubre (I+12), Hospital Universitario 12 de Octubre, Madrid, España; Red de Trastornos Adictivos (RETIS), Instituto Carlos III, Madrid, España. Electronic address: marta.marin@salud.madrid.org.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'López-Trabada', 'Affiliation': 'Servicio de Psiquiatría, Hospital Universitario 12 de Octubre, Madrid, España; Instituto de Investigación 12 de Octubre (I+12), Hospital Universitario 12 de Octubre, Madrid, España; Red de Trastornos Adictivos (RETIS), Instituto Carlos III, Madrid, España.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Arias', 'Affiliation': 'Servicio de Psiquiatría, Hospital Universitario 12 de Octubre, Madrid, España; Instituto de Investigación 12 de Octubre (I+12), Hospital Universitario 12 de Octubre, Madrid, España; Red de Trastornos Adictivos (RETIS), Instituto Carlos III, Madrid, España.'}]",Atencion primaria,['10.1016/j.aprim.2020.04.010']
1482,32695229,Hemorheological Alterations in Patients with Heart Failure with Reduced Ejection Fraction Treated by Resveratrol.,"Objectives


Several beneficial effects of resveratrol have already been published. This study evaluated the effect of resveratrol on the hemorheological parameters in patients with heart failure with reduced ejection fraction.
Methods


In our double-blind, placebo-controlled human clinical trial, we enrolled 60 outpatients with heart failure. Patients were randomized into two groups: receiving either 100 mg resveratrol capsule daily or placebo for 3 months. Hematocrit was determined by microhematocrit centrifuge. Plasma and whole blood viscosity was evaluated by capillary viscometer. Erythrocyte aggregation was measured by both LORCA and Myrenne aggregometers. LORCA ektacytometer was used for measuring erythrocyte deformability. Exercise capacity was assessed by a 6-minute walk test.
Results


Resveratrol treatment did not have any significant effect on hematocrit and viscosity. The erythrocyte deformability also remained unchanged. However, significant improvement of red blood cell aggregation was observed in the resveratrol group compared to baseline after 3 months. Furthermore, positive correlation was found between the exercise capacity and the hemorheological properties (Hct, WBV, and RBC aggregation and deformability) as well.
Conclusion


These findings indicate that resveratrol can significantly reduce red blood cell aggregation, which may positively influence microcirculation, which may contribute to the improvement of tissue perfusion and oxygen supply in heart failure.",2020,"Results


Resveratrol treatment did not have any significant effect on hematocrit and viscosity.","['60 outpatients with heart failure', 'patients with heart failure with reduced ejection fraction', 'Patients with Heart Failure with Reduced Ejection Fraction Treated by Resveratrol']","['100\u2009mg resveratrol capsule daily or placebo', 'placebo']","['Plasma and whole blood viscosity', 'erythrocyte deformability', 'Hemorheological Alterations', 'exercise capacity and the hemorheological properties (Hct, WBV, and RBC aggregation and deformability', 'Exercise capacity', 'hemorheological parameters', 'hematocrit and viscosity', 'Hematocrit', 'red blood cell aggregation', 'Erythrocyte aggregation']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0427691', 'cui_str': 'Whole blood viscosity measurement'}, {'cui': 'C0014774', 'cui_str': 'Erythrocyte deformability'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0014766', 'cui_str': 'Erythrocyte Aggregation'}]",60.0,0.117976,"Results


Resveratrol treatment did not have any significant effect on hematocrit and viscosity.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Gal', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pécs, Hungary.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Praksch', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pécs, Hungary.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kenyeres', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pécs, Hungary.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Rabai', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pécs, Hungary.'}, {'ForeName': 'Kalman', 'Initials': 'K', 'LastName': 'Toth', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pécs, Hungary.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Halmosi', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pécs, Hungary.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Habon', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pécs, Hungary.'}]",Cardiovascular therapeutics,['10.1155/2020/7262474']
1483,32694162,Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD: A Randomized Trial.,"BACKGROUND AND OBJECTIVES


Ferric citrate is an oral medication approved for treatment of iron deficiency anemia in patients with CKD not requiring dialysis. The relative efficacy of ferric citrate versus ferrous sulfate in treating iron deficiency in patients with CKD is unclear.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We randomized 60 adults with moderate to severe CKD (eGFR 15-45 ml/min per 1.73 m 2 ) and iron deficiency (transferrin saturation [TSAT] ≤30% and ferritin ≤300 ng/ml) to ferric citrate (2 g three times a day with meals,  n =30) or ferrous sulfate (325 mg three times a day,  n =30) for 12 weeks. Primary outcomes were change in TSAT and ferritin from baseline to 12 weeks. Secondary outcomes were change in hemoglobin, fibroblast growth factor 23 (FGF23), and hepcidin.
RESULTS


Baseline characteristics were well balanced between study arms. There was a greater increase in TSAT (between-group difference in mean change, 8%; 95% confidence interval [95% CI], 1 to 15;  P =0.02) and ferritin (between-group difference in mean change, 37 ng/ml; 95% CI, 10 to 64;  P =0.009) from baseline to 12 weeks in participants randomized to ferric citrate as compared with ferrous sulfate. Similarly, as compared with ferrous sulfate, treatment with ferric citrate resulted in a greater increase in hepcidin from baseline to 12 weeks (between-group difference, 69 pg/ml; 95% CI, 8 to 130). There were no between-group differences in mean change for hemoglobin (0.3 g/dl; 95% CI, -0.2 to 0.8), intact FGF23 (-29 pg/ml; 95% CI, -59 to 0.1), or C-terminal FGF23 (61 RU/ml; 95% CI, -181 to 58). The incidence of adverse events did not differ between treatment arms.
CONCLUSIONS


As compared with ferrous sulfate, treatment with ferric citrate for 12 weeks resulted in a greater mean increase in TSAT and ferritin concentrations in individuals with moderate to severe CKD and iron deficiency.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With Moderate to Severe Chronic Kidney Disease (CKD) With Iron Deficiency, NCT02888171.",2020,"There was a greater increase in TSAT (between-group difference in mean change, 8%; 95% confidence interval [95% CI], 1 to 15;  P =0.02) and ferritin (between-group difference in mean change, 37 ng/ml; 95% CI, 10 to 64;  P =0.009) from baseline to 12 weeks in participants randomized to ferric citrate as compared with ferrous sulfate.","['60 adults with moderate to severe CKD (eGFR 15-45 ml/min per 1.73 m 2 ) and iron deficiency (transferrin saturation [TSAT] ≤30% and ferritin ≤300 ng/ml) to', 'individuals with moderate to severe CKD and iron deficiency', 'patients with CKD not requiring dialysis', 'Individuals With Moderate to Severe Chronic Kidney Disease (CKD', 'patients with CKD', 'Patients with Iron Deficiency and CKD']","['Ferric Citrate versus Ferrous Sulfate', 'ferric citrate', 'ferrous sulfate', 'Ferric Citrate vs Ferrous Sulfate', 'ferric citrate (2 g three times a day with meals,  n =30) or ferrous sulfate', 'ferric citrate versus ferrous sulfate']","['mean change for hemoglobin', 'TSAT', 'change in TSAT and ferritin', 'TSAT and ferritin concentrations', 'ferritin', 'hepcidin', 'change in hemoglobin, fibroblast growth factor 23 (FGF23), and hepcidin', 'intact FGF23', 'incidence of adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0060231', 'cui_str': 'ferric citrate'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C4553624', 'cui_str': 'With meals'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C3272931', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.220652,"There was a greater increase in TSAT (between-group difference in mean change, 8%; 95% confidence interval [95% CI], 1 to 15;  P =0.02) and ferritin (between-group difference in mean change, 37 ng/ml; 95% CI, 10 to 64;  P =0.009) from baseline to 12 weeks in participants randomized to ferric citrate as compared with ferrous sulfate.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Womack', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Berru', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Bhupesh', 'Initials': 'B', 'LastName': 'Panwar', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Orlando M', 'Initials': 'OM', 'LastName': 'Gutiérrez', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama ogutierrez@uabmc.edu.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.15291219']
1484,32700009,Comparison of Rapid Absorbable Sutures with Nonabsorbable Sutures in Closing Transcolumellar Incision in Septorhinoplasty: Short-term Outcomes.,"BACKGROUND


Following open rhinoplasty, a postoperative scar at the columellar incision line is a common morbidity. The aim of this study is to compare absorbable and nonabsorbable suture materials which had been used for closing the transcolumellar incision, in the aspect of risk of postoperative infection, wound healing, postoperative columellar scar and patient satisfaction.
METHOD


A prospective, randomized, single-blind study was conducted between May 2017 and February 2018. Sixty-four rhinoplasty patients were randomly assigned to absorbable (n = 32) or nonabsorbable (n = 32) groups. The columellar incision was closed with 7 full-thickness skin sutures. Either nonabsorbable 6/0 polypropylene (Group 1) or absorbable 6/0 polyglytone 6211 (Group 2) sutures were placed at the columellar incisions. Polypropylene sutures were removed at the 7th postoperative day. A Mann-Whitney U test and Monte Carlo were used for statistical comparison. Photographs of the patients at the postoperative third month (Fig. 2) were evaluated and scored in terms of scarring, pigmentation, notching, level differences in the incision area by two different otorhinolaryngologists who did not know the randomization. Suture removing discomfort was assessed with visual analogue scale scores. A satisfaction survey was filled out by all the patients completing their third month after the operation.
RESULTS


According to the results of both otorhinolaryngologists, there was no significant difference between the two groups in terms of pigmentation, level difference, notching, overall appearance and total score (p = 0.920, p = 0.498, respectively). The mean score on the Wong-Baker scale was 3.19 ± 1.67 in group 1. In the Satisfaction Survey, the average score of the group 1 was 6.90 ± 3.24, while the mean score of the group 2 was 7.062 ± 2.77. There was no statistically significant difference between the two groups (p = 0.715).
CONCLUSIONS


Suturing inverted V transcolumellar incisions with rapid resorbable sutures caused significantly less discomfort but no difference in scarring compared to nonresorbable sutures as evaluated by patients and observers.
LEVEL OF EVIDENCE III


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,"According to the results of both otorhinolaryngologists, there was no significant difference between the two groups in terms of pigmentation, level difference, notching, overall appearance and total score (p = 0.920, p = 0.498, respectively).","['Sixty-four rhinoplasty patients', 'May 2017 and February 2018']","['absorbable and nonabsorbable suture materials', 'Polypropylene sutures', 'Rapid Absorbable Sutures with Nonabsorbable Sutures', 'absorbable (n\u2009=\u200932) or nonabsorbable', 'nonabsorbable 6/0 polypropylene (Group 1) or absorbable 6/0 polyglytone 6211 (Group 2) sutures were placed at the columellar incisions']","['Suture removing discomfort', 'scarring', 'discomfort', 'pigmentation, level difference, notching, overall appearance and total score', 'visual analogue scale scores', 'mean score on the Wong-Baker scale']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0491217', 'cui_str': 'Polypropylene suture'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0032582', 'cui_str': 'Polypropylene'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1702173', 'cui_str': 'polyglytone 6211'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",64.0,0.0358099,"According to the results of both otorhinolaryngologists, there was no significant difference between the two groups in terms of pigmentation, level difference, notching, overall appearance and total score (p = 0.920, p = 0.498, respectively).","[{'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Erol', 'Affiliation': 'Department of Otorhinolaryngology, Elmadag Hulusi Alatas State Hospital, Ankara, Turkey. ozzy.erol@gmail.com.'}, {'ForeName': 'Fuat', 'Initials': 'F', 'LastName': 'Buyuklu', 'Affiliation': 'Department of Otorhinolaryngology, Baskent University Hospital, Ankara, Turkey.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Koycu', 'Affiliation': 'Department of Otorhinolaryngology, Baskent University Hospital, Ankara, Turkey.'}, {'ForeName': 'Sabuhi', 'Initials': 'S', 'LastName': 'Jafarov', 'Affiliation': 'Department of Otorhinolaryngology, Baskent University Hospital, Ankara, Turkey.'}, {'ForeName': 'Goknil', 'Initials': 'G', 'LastName': 'Gultekin', 'Affiliation': 'Department of Otorhinolaryngology, Baskent University Hospital, Ankara, Turkey.'}, {'ForeName': 'Selim S', 'Initials': 'SS', 'LastName': 'Erbek', 'Affiliation': 'Department of Otorhinolaryngology, Baskent University Hospital, Ankara, Turkey.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01864-2']
1485,32660159,The Effectiveness of a Dyadic Pain Management Program for Community-Dwelling Older Adults with Chronic Pain: A Pilot Randomized Controlled Trial.,"BACKGROUND


Chronic pain is a major health problem among older adults and their informal caregivers, which has negative effects on their physical and psychological status. The dyadic pain management program (DPMP) is provided to community-dwelling older adults and informal caregivers to help the dyads reduce pain symptoms, improve the quality of life, develop good exercise habits, as well as cope and break the vicious circle of pain.
METHODS


A pilot randomized controlled trial was designed and all the dyads were randomly divided into two groups: the DPMP group and control group. Dyads in the DPMP group participated in an 8-week DPMP (4-week face-to-face program and 4-week home-based program), whereas dyads in the control group received one page of simple pain-related information.
RESULTS


In total, 64 dyads participated in this study. For baseline comparisons, no significant differences were found between the two groups. After the interventions, the pain score was significantly reduced from 4.25 to 2.57 in the experimental group, respectively. In the repeated measures ANOVA, the differences in pain score (F = 107.787,  p  < 0.001,  d  = 0.777) was statistically significant for the group-by-time interaction. After the interventions, the experimental group participants demonstrated significantly higher pain self-efficacy compared with the control group (F = 80.535,  p  < 0.001,  d  = 0.722). Furthermore, the elderly increased exercise time significantly (F = 111.212,  p  < 0.001,  d  = 0.782) and reported developing good exercise habits.
CONCLUSIONS


These results provide preliminary support for the effectiveness of a DPMP for relieving the symptoms of chronic pain among the elderly.",2020,"Furthermore, the elderly increased exercise time significantly (F = 111.212,  p  < 0.001,  d  = 0.782) and reported developing good exercise habits.
","['Community-Dwelling Older Adults with Chronic Pain', 'older adults and their informal caregivers', '64 dyads participated in this study', 'community-dwelling older adults and informal caregivers']","['dyadic pain management program (DPMP', 'DPMP', 'Dyadic Pain Management Program', '8-week DPMP (4-week face-to-face program and 4-week home-based program), whereas dyads in the control group received one page of simple pain-related information', 'DPMP group and control group']","['exercise time', 'pain score', 'pain self-efficacy']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",64.0,0.025096,"Furthermore, the elderly increased exercise time significantly (F = 111.212,  p  < 0.001,  d  = 0.782) and reported developing good exercise habits.
","[{'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Tse', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17144966']
1486,32661909,"Pharmacokinetic and Pharmacodynamic Studies of Elacestrant, A Novel Oral Selective Estrogen Receptor Degrader, in Healthy Post-Menopausal Women.","BACKGROUND AND OBJECTIVES


Advanced estrogen receptor-positive (ER+) breast cancer is currently treated with endocrine therapy. Elacestrant is a novel, nonsteroidal, selective estrogen receptor degrader with complex dose-related ER agonist/antagonist activity that is being developed as a treatment option for ER+ breast cancer.
METHODS


Two first-in-human phase 1 studies of elacestrant in healthy postmenopausal women (Study 001/Study 004) were conducted to determine its pharmacokinetic and pharmacodynamic profile as well as its safety and maximum tolerated dose.
RESULTS


In total, 140 postmenopausal subjects received at least one dose of study drug (114 received elacestrant and 26 received placebo). Single-ascending dose and multiple-ascending dose assessments showed that doses up to 1000 mg daily were safe and well tolerated, and the maximum tolerated dose was not reached. Oral administration of elacestrant had an absolute bioavailability of 10% and a mean half-life ranging from 27 to 47 h, reaching steady state after 5-6 days. Mean occupancy of the ER in the uterus after seven daily doses was 83% for 200 mg and 92% for 500 mg daily. The median ratio of elacestrant concentrations in the cerebral spinal fluid vs. plasma was 0.126% (500 mg dose) and 0.205% (200 mg dose). Most adverse events were related to the upper gastrointestinal tract.
CONCLUSIONS


These data demonstrate that elacestrant has good bioavailability when administered orally with a half-life that supports once-daily administration. Engagement of the ER and some ability to cross the blood-brain barrier was demonstrated in addition to an acceptable safety profile.",2020,Mean occupancy of the ER in the uterus after seven daily doses was 83% for 200 mg and 92% for 500 mg daily.,"['Two first-in-human phase 1 studies of elacestrant in healthy postmenopausal women (Study 001/Study 004', 'Healthy Post-Menopausal Women', '140 postmenopausal subjects received at least one dose of study drug (114 received elacestrant and 26 received']",['placebo'],"['absolute bioavailability', 'median ratio of elacestrant concentrations', 'Mean occupancy of the ER', 'safe and well tolerated']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0920321', 'cui_str': 'Phase I Clinical Trials'}, {'cui': 'C4682404', 'cui_str': 'elacestrant'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4682404', 'cui_str': 'elacestrant'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",4.0,0.0994447,Mean occupancy of the ER in the uterus after seven daily doses was 83% for 200 mg and 92% for 500 mg daily.,"[{'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Conlan', 'Affiliation': 'Department of Oncology Clinical Development, Radius Health, Inc., 950 Winter Street, Waltham, MA, 02451, USA. mconlan@radiuspharm.com.'}, {'ForeName': 'Erik F J', 'Initials': 'EFJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'Awjm', 'Initials': 'A', 'LastName': 'Glaudemans', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Radius Health, Inc., 950 Winter Street, Waltham, MA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Troy', 'Affiliation': 'Department of Clinical Pharmacology, Radius Health, Inc., 950 Winter Street, Waltham, MA, USA.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00635-3']
1487,32665197,Sutureless versus interrupted sutures techniques for neonatal circumcision; a randomized clinical trial.,"INTRODUCTION


and objective: Male circumcision is a common procedure all over the world; in Saudi Arabia, circumcision is the most frequent elective surgical procedure performed on males. The use of sutures for neonatal circumcision may decrease bleeding; however, it may lead to skin sinus formation. The objective of this study was to compare the sutureless to the interrupted sutures technique for neonatal circumcision with Gamco clamp.
PATIENTS AND METHODS


We performed a randomized controlled clinical trial between 2017 and 2018. The study included 182 newborns assigned into two groups. Group 1 (n = 94) included neonates who had sutureless circumcision, and group 2 (n = 89) included neonates who underwent circumcision using interrupted absorbable 6/0 sutures. Study endpoints were bleeding, wound gaping, skin tunneling or sinus, and cyst formation.
RESULTS


There was no significant difference in patients' age and weight between groups. The procedure was significantly longer in group 2 (12.24 ± 2.17 vs. 6.54 ± 1.42 min; p < 0.001). There was no difference in bleeding between both groups (4 (4.26%) vs. 2 (2.27%) in groups 1 and 2, respectively, p = 0.683). Cyst formation was significantly reduced in group 1 (2 (2.13%) vs. 13 (14.77%); p = 0.002) and skin sinus formation increased in group 2 (14 (15.91%) vs. 0 in group 2 and 1, respectively; p < 0.001).
DISCUSSION


Circumcision can be performed with several techniques, and the superiority of one approach over the other is still debated. Many surgeons use interrupted sutures to oppose the skin edges, and in some reports, tissue glue was used for skin edges re-approximation with acceptable cosmetic results. In our study, the mean time taken for sutureless circumcision was about 7 min, and for the suture circumcision, it took around 11 min. In addition, the formation of a skin tunnel or sinuses rate was high despite the use of very thin sutures.
CONCLUSION


Male circumcision is a common and safe technique with minor and treatable complications. Risks of bleeding and sinus track formation are low with the sutureless method. The sutureless technique is recommended after Gamco circumcision as the standard technique for male circumcision in the newborn.",2020,"Cyst formation was significantly reduced in group 1 (2 (2.13%) vs. 13 (14.77%); p = 0.002) and skin sinus formation increased in group 2 (14 (15.91%) vs. 0 in group 2 and 1, respectively; p < 0.001).
","['182 newborns assigned into two groups', '2017 and 2018', 'Group 1 (n\xa0=\xa094) included neonates who had sutureless circumcision, and group 2 (n\xa0=\xa089) included neonates who underwent']","['Sutureless versus interrupted sutures techniques', 'circumcision using interrupted absorbable 6/0 sutures']","['formation of a skin tunnel or sinuses rate', 'Risks of bleeding and sinus track formation', 'mean time taken for sutureless circumcision', 'bleeding, wound gaping, skin tunneling or sinus, and cyst formation', 'skin sinus formation', 'bleeding', 'Cyst formation']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0423772', 'cui_str': 'External fistula'}]",182.0,0.0270562,"Cyst formation was significantly reduced in group 1 (2 (2.13%) vs. 13 (14.77%); p = 0.002) and skin sinus formation increased in group 2 (14 (15.91%) vs. 0 in group 2 and 1, respectively; p < 0.001).
","[{'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Bawazir', 'Affiliation': 'Department of Surgery, Faculty of medicine Umm Al-Qura University, Makkah& King Faisal Specialist Hospital & Research Centre, Saudi Arabia. Electronic address: obawazir@yahoo.com.'}, {'ForeName': 'Abdulaziz M', 'Initials': 'AM', 'LastName': 'Banaja', 'Affiliation': 'Department of Surgery, Faculty of medicine Umm Al-Qura University, Makkah& King Faisal Specialist Hospital & Research Centre, Saudi Arabia. Electronic address: Azizbanaja@hotmail.com.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.06.025']
1488,32663479,The Effect of Proprioceptive Exercises on Balance and Physical Function in Institutionalized Older Adults: A Randomized Controlled Trial.,"OBJECTIVES


To evaluate the efficacy of a proprioceptive exercise program on functional mobility, musculoskeletal endurance, dynamic and static balance, gait, and risk of falls in institutionalized older adults.
DESIGN


Randomized, single-blind, controlled trial.
SETTING


A Spanish nursing home in the autonomous community of Extremadura, Spain.
PARTICIPANTS


An initial sample was created by recruiting 148 older adult volunteers. The final sample (N=42) was randomly divided into 2 groups.
INTERVENTIONS


Both the control and experimental group received physical therapy treatment based on a combination of adapted exercises and other physical therapy techniques (physical therapy intervention program) for a period of 12 weeks. This program consisted of 45 minutes (group intervention) plus 100 minutes (individual intervention) a week, for a total of 36 sessions (29 hours). The experimental group received a proprioceptive training program during the same intervention period, which was conducted twice weekly (24 sessions), with each session lasting 55 minutes.
MAIN OUTCOME MEASURES


Timed Up and Go (TUG), Cooper, Tinetti, 1-leg stance, and the Morse Fall Scale (MFS).
RESULTS


Analysis of variance showed a time × group interaction in TUG score (F=10.41, P=.002), Cooper test (F=5.94, P=.019), Tinetti score (F=6.41, P=.015), and MFS scores (F=5.24, P=.028). Differences between groups were achieved for TUG scores (d=0.76), Tinetti scores (d=1.12), 1-leg stance test scores (d=0.77), and MFS scale scores (d=0.85). In the experimental group, within-group analyses showed pre- to post-treatment differences for TUG scores (d=0.72), Cooper test scores in meters (d=0.18), Tinetti scores (d=0.60), 1-leg stance scores (d=0.55), and MFS scores (d=0.42).
CONCLUSIONS


A proprioceptive exercise program demonstrated significant improvements compared with the control group in areas such as functional mobility, musculoskeletal endurance, balance, gait, and risk of falls in institutionalized older adults. This study may help to enhance our understanding of the impact of a specific protocol for a proprioceptive rehabilitation program.",2020,"A proprioceptive exercise program produced significant improvements compared to the control group in areas such as functional mobility, musculoskeletal endurance, balance, gait, and risk of falls in institutionalized older adults.","['institutionalized older adults', '148 older adult volunteers', 'A Spanish nursing home from the Autonomous Community of Extremadura, Spain']","['physical therapy treatment based on a combination of adapted exercises and other physical therapy techniques (physical therapy intervention program', 'proprioceptive exercises', 'proprioceptive exercise program', 'proprioceptive training program']","['functional mobility, musculoskeletal endurance, balance, gait, and risk of falls', 'functional mobility, musculoskeletal endurance, dynamic and static balance, gait, and risk of falls', 'Tinetti scores', 'Cooper test', 'MORSE scores', 'TUG scores', 'balance and physical function', 'MORSE scale scores', 'One-Leg Stance test scores', 'time x group interaction in TUG scores', 'One-Leg Stance scores']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029709', 'cui_str': 'Other physical therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0454280', 'cui_str': 'Proprioceptive exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0335912', 'cui_str': 'Cooper'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",148.0,0.0221272,"A proprioceptive exercise program produced significant improvements compared to the control group in areas such as functional mobility, musculoskeletal endurance, balance, gait, and risk of falls in institutionalized older adults.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Espejo-Antúnez', 'Affiliation': 'Department of Medical-Surgical Therapy, Medicine Faculty, Extremadura University, Badajoz, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Pérez-Mármol', 'Affiliation': 'Department of Physiotherapy, Faculty of Health Sciences, University of Granada, Granada, Spain. Electronic address: josemapm@ugr.es.'}, {'ForeName': 'M de Los Ángeles', 'Initials': 'MLÁ', 'LastName': 'Cardero-Durán', 'Affiliation': 'Puente Real II Healthcare Center, Avda. Federico Mayor Zaragoza, Badajoz, Spain.'}, {'ForeName': 'José Vicente', 'Initials': 'JV', 'LastName': 'Toledo-Marhuenda', 'Affiliation': 'Department of Pathology and Surgery, Area of Physiotherapy, Medicine Faculty, Miguel Hernández University, Alicante, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Albornoz-Cabello', 'Affiliation': 'Department of Physiotherapy, University of Sevilla, Sevilla, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.06.010']
1489,32663640,"A commentary on ""Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial"" (Int J Surg 2020;80:13-18).",,2020,,['Elderly Patients undergoing Hip Joint Replacement Surgery'],['Edaravone'],['Postoperative Cognitive Function'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.104829,,"[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Woo', 'Affiliation': 'School of Medicine, Cardiff University, University Hospital of Wales, Heath Park, Cardiff, CF14 4XN, United Kingdom. Electronic address: wootk@cardiff.ac.uk.'}, {'ForeName': 'Sashiananthan', 'Initials': 'S', 'LastName': 'Ganesananthan', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, United Kingdom.'}, {'ForeName': 'ChunHei', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, United Kingdom.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.001']
1490,32663660,"Rationale and design of the RIGHT trial: A multicenter, randomized, double-blind, placebo-controlled trial of anticoagulation prolongation versus no anticoagulation after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.","BACKGROUND


Current guidelines recommend anticoagulation therapy during primary percutaneous coronary intervention (pPCI) for ST-segment elevation myocardial infarction (STEMI). However, whether anticoagulation should be continued after pPCI has not been well investigated.
METHODS/DESIGN


The RIGHT trial is a prospective, multicenter, randomized, double-blind, placebo-controlled trial in STEMI patients treated with pPCI evaluating the prolongation of anticoagulation after the procedure. Patients are randomized in a 1:1 fashion to receive either prolonged anticoagulant or matching placebo (no anticoagulation) for at least 48 hours after the procedure. When randomized to anticoagulation prolongation, the patient is assigned to intravenous unfractionated heparin (UFH) or subcutaneous enoxaparin or intravenous bivalirudin (same drug and same regimen at each center). The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days. The primary safety endpoint is major bleeding (BARC 3-5) at 30 days. Based on a superiority design and assuming a 35% relative risk reduction (from 7% to 4.5%), 2856 patients will be enrolled, accounting for a 5% drop-out rate (α = 0.05 and power = 80%).
CONCLUSION


The RIGHT trial tests the hypothesis that post-procedural anticoagulation is superior to no anticoagulation in reducing ischemic events in STEMI patients undergoing pPCI.",2020,"The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days.","['STEMI patients undergoing pPCI', 'STEMI patients treated with pPCI evaluating the prolongation of anticoagulation after the procedure', 'after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction']","['prolonged anticoagulant or matching placebo (no anticoagulation', 'unfractionated heparin (UFH) or subcutaneous enoxaparin or intravenous bivalirudin', 'anticoagulation prolongation versus no anticoagulation', 'placebo']","['composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel', 'major bleeding (BARC 3-5', 'ischemic events']","[{'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",2856.0,0.600901,"The primary efficacy endpoint is the composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, stent thrombosis (definite) or urgent revascularization (any vessel) at 30 days.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: eva3321@sina.com.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: spaceeye123@126.com.'}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Beijing Luhe Hospital, Capital Medical University, Beijing, China. Electronic address: guojcmd@126.com.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Second Hospital of Hebei Medical University, Shijiazhuang, China. Electronic address: lyjbs2009@yeah.net.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ai', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: aihui0814@126.com.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: tjmusky@126.com.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Que', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: quebin@sohu.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhen', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: 13439546840@yeah.net.'}, {'ForeName': 'Jiapeng', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: jiapeng.lu@fwoxford.org.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. Electronic address: chshma@vip.sina.com.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Nie', 'Affiliation': 'Emergency & Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; Beijing Institute of Heart, Lung, and Blood Vessel Diseases, Beijing, China. Electronic address: spnie@ccmu.edu.cn.'}]",American heart journal,['10.1016/j.ahj.2020.06.005']
1491,32671719,Cabozantinib for the Treatment of Advanced Hepatocellular Carcinoma: Current Data and Future Perspectives.,"Cabozantinib (Cabometyx ® ) is a potent multikinase inhibitor targeting the vascular endothelial growth factor (VEGF) receptor 2, the mesenchymal-epithelial transition factor (MET) receptor, and the ""anexelekto"" (AXL) receptor tyrosine kinase. It is approved for the treatment of advanced hepatocellular carcinoma (HCC) after failure of sorafenib in Europe (since November 2018) and in the USA (since January 2019). The approval of cabozantinib was based on results of the randomized, placebo-controlled, phase 3 CELESTIAL trial in patients with unresectable HCC, who received one or two prior lines of treatment including sorafenib. At the second planned interim analysis, the trial was stopped, because the primary end point overall survival was clearly in favor for cabozantinib. Additionally, median progression-free survival was superior to placebo. The most common ≥ grade 3 relevant adverse events in patients with HCC treated with cabozantinib were palmar-plantar erythrodysesthesia, hypertension, fatigue, and diarrhea. In this review, current data on cabozantinib for the treatment of patients with advanced HCC, with a focus on the management of common adverse events and ongoing clinical trials, are discussed.",2020,"Additionally, median progression-free survival was superior to placebo.","['patients with advanced HCC', 'Advanced Hepatocellular Carcinoma', 'patients with unresectable HCC, who received one or two prior lines of treatment including', 'advanced hepatocellular carcinoma (HCC) after failure of sorafenib in Europe (since\xa0November 2018) and in the USA (since January 2019']","['Cabozantinib (Cabometyx ® ', 'sorafenib', 'Cabozantinib', 'placebo']","['palmar-plantar erythrodysesthesia, hypertension, fatigue, and diarrhea', 'overall survival', 'median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C4237933', 'cui_str': 'Cabometyx'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.065429,"Additionally, median progression-free survival was superior to placebo.","[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Trojan', 'Affiliation': 'Universitätsklinikum Frankfurt, Medizinische Klinik 1, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany. trojan@em.uni-frankfurt.de.'}]",Drugs,['10.1007/s40265-020-01361-5']
1492,32675074,BCI training to move a virtual hand reduces phantom limb pain: A randomized crossover trial.,"OBJECTIVE


To determine whether training with a brain-computer interface (BCI) to control an image of a phantom hand, which moves based on cortical currents estimated from magnetoencephalographic signals, reduces phantom limb pain.
METHODS


Twelve patients with chronic phantom limb pain of the upper limb due to amputation or brachial plexus root avulsion participated in a randomized single-blinded crossover trial. Patients were trained to move the virtual hand image controlled by the BCI with a real decoder, which was constructed to classify intact hand movements from motor cortical currents, by moving their phantom hands for 3 days (""real training""). Pain was evaluated using a visual analogue scale (VAS) before and after training, and at follow-up for an additional 16 days. As a control, patients engaged in the training with the same hand image controlled by randomly changing values (""random training""). The 2 trainings were randomly assigned to the patients. This trial is registered at UMIN-CTR (UMIN000013608).
RESULTS


VAS at day 4 was significantly reduced from the baseline after real training (mean [SD], 45.3 [24.2]-30.9 [20.6], 1/100 mm;  p  = 0.009 < 0.025), but not after random training ( p  = 0.047 > 0.025). Compared to VAS at day 1, VAS at days 4 and 8 was significantly reduced by 32% and 36%, respectively, after real training and was significantly lower than VAS after random training ( p  < 0.01).
CONCLUSION


Three-day training to move the hand images controlled by BCI significantly reduced pain for 1 week.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that BCI reduces phantom limb pain.",2020,"Compared to VAS at day 1, VAS at days 4 and 8 was significantly reduced by 32% and 36%, respectively, after real training and was significantly lower than VAS after random training ( p  < 0.01).
",['Twelve patients with chronic phantom limb pain of the upper limb due to amputation or brachial plexus root avulsion participated'],"['VAS', 'training with a brain-computer interface (BCI', 'BCI', 'BCI training']","['phantom limb pain', 'visual analogue scale (VAS', 'Pain', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0457886', 'cui_str': 'Root of brachial plexus'}, {'cui': 'C0185044', 'cui_str': 'Surgical avulsion'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",12.0,0.0973384,"Compared to VAS at day 1, VAS at days 4 and 8 was significantly reduced by 32% and 36%, respectively, after real training and was significantly lower than VAS after random training ( p  < 0.01).
","[{'ForeName': 'Takufumi', 'Initials': 'T', 'LastName': 'Yanagisawa', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan. tyanagisawa@nsurg.med.osaka-u.ac.jp.'}, {'ForeName': 'Ryohei', 'Initials': 'R', 'LastName': 'Fukuma', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Seymour', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hosomi', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Okito', 'Initials': 'O', 'LastName': 'Yamashita', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Kishima', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Yukiyasu', 'Initials': 'Y', 'LastName': 'Kamitani', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}, {'ForeName': 'Youichi', 'Initials': 'Y', 'LastName': 'Saitoh', 'Affiliation': 'From the Institute for Advanced Co-Creation Studies (T.Y.), Osaka University; Departments of Neurosurgery (T.Y., R.F., M.T., K.H., H.K., Y.S.) and Neuromodulation and Neurosurgery (K.H., Y.S.), Osaka University Graduate School of Medicine; Department of Neuroinformatics (T.Y., R.F., Y.K.), ATR Computational Neuroscience Laboratories, Kyoto, Japan; Computational and Biological Learning Laboratory, Department of Engineering (B.S.), University of Cambridge, UK; Center for Information and Neural Networks (B.S.), National Institute for Information and Communications Technology, Osaka; RIKEN Center for Advanced Intelligence Project (O.Y.), Tokyo; Department of Computational Brain Imaging (O.Y.), ATR Neural Information Analysis Laboratories, Kyoto; and Graduate School of Informatics (Y.K.), Kyoto University, Japan.'}]",Neurology,['10.1212/WNL.0000000000009858']
1493,32673652,Can the Positional Release Technique Affect Central Sensitization in Patients With Chronic Tension-Type Headache? A Randomized Clinical Trial.,"OBJECTIVES


To investigate whether the positional release technique (PRT) affects central sensitization in patients with chronic tension-type headache (TTH).
DESIGN


Randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis.
SETTING


Two university neurology clinics.
PARTICIPANTS


Patients (N=32) with TTH and myofascial trigger points (MTrP) in their cervical muscles.
INTERVENTIONS


Patients in the PRT group received 10 treatment sessions for each of their MTrPs over the course of 5 weeks. All participants could use ibuprofen 200 mg for their headaches during the study.
MAIN OUTCOME MEASURES


The primary outcome measure was brain metabolite profile. The secondary outcome measures were headache frequency and intensity, McGill score, and pressure pain threshold (PPT), which were evaluated in each participant during 5 weeks with proton magnetic resonance spectroscopy, patients' self-reports, the McGill Pain Questionnaire, and a pressure algometer.
RESULTS


Analysis of the data from 26 patients showed that headache frequency (P=.001), headache intensity (P=.002), McGill score (P=.003), and local PPT (P=.003) changed significantly after PRT. The myo-inositol/creatine concentration ratio in the somatosensory cortex (P=.041) decreased significantly in the control group. Furthermore, there were significant differences between groups in headache frequency (P<.001), headache intensity (P<.001), McGill score (P<.001), local PPT (P=.004), distal PPT (P=.041), and glutamate-glutamine/creatine concentration ratio in the thalamus (P=.014).
CONCLUSIONS


These findings indicate that PRT did not affect central sensitization in patients with TTH despite the improvement in clinical symptoms.",2020,Myo-inositol/creatine concentration ratio in the somatosensory cortex (p=0.041) decreased significantly in the control group.,"['patients with chronic TTH', 'patients with TTH', '32 patients with TTH and MTrPs in their cervical muscles', 'patients with chronic tension-type headache', 'Two university neurology clinics']","['positional release technique (PRT', 'ibuprofen']","['McGill Pain Questionnaire and a pressure algometer', 'headache frequency', 'distal PPT', 'brain metabolite profile', 'McGill score', 'local PPT', 'headache frequency and intensity, McGill score, and pressure pain threshold', 'headache intensity', 'Myo-inositol/creatine concentration ratio', 'headache intensity (p<0.001), McGill score (p<0.001), local PPT', 'glutamate-glutamine/creatine concentration ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0393738', 'cui_str': 'Chronic tension-type headache'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}]","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]",32.0,0.145641,Myo-inositol/creatine concentration ratio in the somatosensory cortex (p=0.041) decreased significantly in the control group.,"[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Mohamadi', 'Affiliation': 'Rehabilitation Research Center, Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rojhani-Shirazi', 'Affiliation': 'Rehabilitation Research Center, Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: rojhaniz@sums.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Assadsangabi', 'Affiliation': 'Department of Radiology, Davis School of Medicine, University of California, Sacramento, CA.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Rahimi-Jaberi', 'Affiliation': 'Department of Neurology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.028']
1494,32673830,Accelerated treatment of endocarditis-The POET II trial: Rationale and design of a randomized controlled trial.,"BACKGROUND


The optimal antibiotic treatment length for infective endocarditis (IE) is uncertain. International guidelines recommend treatment duration of up to 6 weeks for patients with left-sided IE but are primarily based on historical data and expert opinion. Efficacies of modern therapies, fast recovery seen in many patients with IE, and complications to long hospital stays challenge the rationale for fixed treatment durations in all patients.
OBJECTIVE


The objective was to conduct a noninferiority randomized controlled trial (acronym POET II) investigating the safety of accelerated (shortened) antibiotic therapy as compared to standard duration in patients with left-sided IE.
METHODS


The POET II trial is a multicenter, multinational, open-label, noninferiority randomized controlled trial. Patients with definite left-sided IE due to Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis will be eligible for enrolment. Each patient will be randomized to accelerated antibiotic treatment or standard-length treatment (1:1) following clinical stabilization as defined by clinical parameters, laboratory values, and transesophageal echocardiography findings. Accelerated treatment will be between 2 and 4 weeks, whereas standard-length treatment will be between 4 and 6 weeks, depending on microbiologic etiology, complications, need for valve surgery, and prosthetic versus native valve endocarditis. The primary outcome is a composite of all-cause mortality, unplanned cardiac surgery, relapse of bacteremia, or embolization within 6 months of randomization.
CONCLUSIONS


The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis. The results of the POET II trial will improve the evidence base of treatment recommendations, and clinical practice may be altered.",2020,"The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis.","['patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis', 'patients with left-sided IE']","['accelerated (shortened) antibiotic therapy', 'accelerated antibiotic therapy']","['microbiologic etiology, complications, need for valve surgery, and prosthetic versus native valve endocarditis', 'composite of all-cause mortality, unplanned cardiac surgery, relapse of bacteremia, or embolization within 6\u202fmonths of randomization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1827151', 'cui_str': 'Left sided infective endocarditis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1142550', 'cui_str': 'Native valve endocarditis'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",,0.224308,"The POET II trial will investigate the safety of accelerated antibiotic therapy for patients with left-sided IE caused by Streptococcus spp, Staphylococcus aureus, or Enterococcus faecalis.","[{'ForeName': 'Lauge', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Mia Marie', 'Initials': 'MM', 'LastName': 'Pries-Heje', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus Bo', 'Initials': 'RB', 'LastName': 'Hasselbalch', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Infectious Diseases, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Åkesson', 'Affiliation': 'Department of Infectious Diseases, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Horvath', 'Affiliation': 'Department of Infectious Diseases, The Prince Charles Hospital, Brisbane, Australia.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Povlsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Niels Eske', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Müllertz', 'Affiliation': 'Department of Cardiology, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Christian Ditlev', 'Initials': 'CD', 'LastName': 'Tuxen', 'Affiliation': 'Department of Cardiology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Ihlemann', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jannik', 'Initials': 'J', 'LastName': 'Helweg-Larsen', 'Affiliation': 'Department of Infectious Diseases, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Moser', 'Affiliation': 'Department of Clinical Microbiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Emil Loldrup', 'Initials': 'EL', 'LastName': 'Fosbøl', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Bundgaard', 'Affiliation': 'The Heart Center, Rigshospitalet, Copenhagen, Denmark. Electronic address: Henning.Bundgaard@regionh.dk.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Iversen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, Copenhagen, Denmark.'}]",American heart journal,['10.1016/j.ahj.2020.05.012']
1495,32679281,"China Tongxinluo Study for myocardial protection in patients with Acute Myocardial Infarction (CTS-AMI): Rationale and design of a randomized, double-blind, placebo-controlled, multicenter clinical trial.","Acute ST-segment elevation myocardial infarction (STEMI) remains a serious life-threatening event. Despite coronary revascularization, patients might still suffer from poor outcomes caused by myocardial no-reflow and ischemic/reperfusion injury. Tongxinluo (TXL), a traditional Chinese medicine, has been preliminarily demonstrated to reduce myocardial no-reflow and ischemic/reperfusion injury. We further hypothesize that TXL treatment is also effective in reducing clinical end points for the patients with STEMI. METHODS AND RESULTS: The CTS-AMI trial is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical study in China. An estimated 3,796 eligible patients with STEMI from about 120 centers are randomized 1:1 ratio to TXL or placebo groups. All enrolled patients are orally administrated a loading dose of 8 capsules of TXL or placebo together with dual antiplatelet agents on admission followed by 4 capsules 3 times a day until 12 months. The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke. Secondary end points include each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters. CONCLUSIONS: Results of CTS-AMI trial will determine the clinical efficacy and safety of traditional Chinese medicine TXL capsule in the treatment of STEMI patients in the reperfusion era.",2020,"The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke.","['patients with Acute Myocardial Infarction (CTS-AMI', '3,796 eligible patients with STEMI from about 120 centers']","['Tongxinluo (TXL', 'TXL', 'TXL or placebo', 'placebo']","['each component of the primary end point, 1-year major adverse cardiovascular and cerebrovascular events, and other efficacy and safety parameters', '30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C1742872', 'cui_str': 'tongxinluo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0948369', 'cui_str': 'Myocardial reinfarction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",3796.0,0.355531,"The primary end point is 30-day major adverse cardiovascular and cerebrovascular events, a composite of cardiac death, myocardial reinfarction, emergency coronary revascularization, and stroke.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Kefei', 'Initials': 'K', 'LastName': 'Dou', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shijie', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lianjun', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaojin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qiuting', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guangyuan', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guihao', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ruijie', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jingang', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Peking University Clinical Research Institute, Peking University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xian', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yuejin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Fuwai Hospital, National Center of Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: yangyjfw@126.com.'}]",American heart journal,['10.1016/j.ahj.2020.06.011']
1496,32679405,A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.,"PURPOSE


Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA.
PATIENTS AND METHODS


E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections.
RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.
CONCLUSIONS


We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.",2020,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","['120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers', 'oropharyngeal cancer (OPC']","['surgeon expertise and surgical quality assurance (QA', 'transoral surgery', 'transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC']","['positive final pathologic margins', 'positive margins, low oropharyngeal bleeding rates', 'Grade III/IV and grade V oropharyngeal bleeding']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0010298', 'cui_str': 'Credentialing'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",120.0,0.0606723,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States. Electronic address: Ferrisrl@upmc.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Flamand', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'F Christopher', 'Initials': 'FC', 'LastName': 'Holsinger', 'Affiliation': 'Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Weinstein', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joaquin J', 'Initials': 'JJ', 'LastName': 'Garcia', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hinni', 'Affiliation': 'Mayo Clinic in Arizona, Phoenix, AZ, United States.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Sturgis', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Umamaheswar', 'Initials': 'U', 'LastName': 'Duvvuri', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Méndez', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Magnuson', 'Affiliation': 'Florida Hospital Orlando, Celebration, FL, United States.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Boston, MA, United States.'}, {'ForeName': 'Mihir R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Russel B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'University of Nebraska, Omaha, NE, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Karakla', 'Affiliation': 'Sentara Norfolk General Hospital, Norfolk, VA, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kupferman', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Malone', 'Affiliation': 'UPMC Pinnacle Cancer Center, Harrisburg, PA, United States.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Judson', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Richmon', 'Affiliation': 'Massachusetts Eye and Ear, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Jay O', 'Initials': 'JO', 'LastName': 'Boyle', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bayon', 'Affiliation': 'University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Bert W', 'Initials': 'BW', 'LastName': ""O'Malley"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Giovana R', 'Initials': 'GR', 'LastName': 'Thomas', 'Affiliation': 'University of Miami Leonard Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Koch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'R Bryan', 'Initials': 'RB', 'LastName': 'Bell', 'Affiliation': 'Providence Cancer Institute, Portland, OR, United States.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104797']
1497,32708906,The Contrasting Effects of an Action Video Game on Visuo-Spatial Processing and Proactive Cognitive Control.,"First person shooter or action video games represent one of the most popular genres within the gaming industry. Studies reveal that action gaming experience leads to enhancements of visuo-spatial processing. In contrast, some correlational evidence reveals that experience with action video games may be associated with reduced proactive cognitive control. The two primary goals of the current study were to test the causal nature of the effect of action gaming on proactive cognitive control and to examine whether an increase in visuo-spatial processing and a decrease in proactive cognitive control arise from the same amount of experience playing an action video game. Participants completed tasks measuring visuo-spatial processing and cognitive control before and after 10 practice sessions involving one of three video games or were assigned to a no gaming experience control group. The data revealed the typical increase in visuo-spatial processing and a decrease in proactive, but not reactive, cognitive control following action game training. The sizes of these two training effects were similar in magnitude, but interpretation of the effects was constrained by baseline differences between the four groups of subjects. The possibility of a causal effect of action gaming on proactive cognitive control is interesting within the context of correlational evidence linking greater action gaming experience to reduced cognitive control, poor decision making, and increased impulsivity.",2020,Participants completed tasks measuring visuo-spatial processing and cognitive control before and after 10 practice sessions involving one of three video games or were assigned to a no gaming experience control group.,[],"['tasks measuring visuo-spatial processing and cognitive control before and after 10 practice sessions involving one of three video games or were assigned to a no gaming experience control group', 'action gaming', 'Action Video Game']","['visuo-spatial processing', 'proactive cognitive control', 'Visuo-Spatial Processing and Proactive Cognitive Control']",[],"[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3850026', 'cui_str': 'Auditory Spatial Processing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C3850026', 'cui_str': 'Auditory Spatial Processing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0152109,Participants completed tasks measuring visuo-spatial processing and cognitive control before and after 10 practice sessions involving one of three video games or were assigned to a no gaming experience control group.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Department of Psychology and Neuroscience, DePauw University, Greencastle, IN 46135, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Swing', 'Affiliation': ""Phoenix Children's Hospital, Phoenix, AZ 85016, USA.""}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychology, Iowa State University, Ames, IA 50010, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Prot', 'Affiliation': 'School of Psychological, Social, and Behavioral Sciences, Coventry University, Coventry CV1 5FB, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17145160']
1498,32682556,Norepinephrine or phenylephrine during spinal anaesthesia for Caesarean delivery: a randomised double-blind pragmatic non-inferiority study of neonatal outcome.,"BACKGROUND


Norepinephrine is an effective vasopressor during spinal anaesthesia for Caesarean delivery. However, before it can be fully recommended, possible adverse effects on neonatal outcome should be excluded. We aimed to test the hypothesis that umbilical arterial cord pH is at least as good (non-inferior) when norepinephrine is used compared with phenylephrine for treatment of hypotension.
METHODS


We enrolled 668 subjects having elective and non-elective Caesarean delivery under spinal or combined spinal-epidural anaesthesia in this randomised, double-blind, two-arm parallel, non-inferiority clinical trial. Arterial blood pressure was maintained using norepinephrine 6 μg ml -1  or phenylephrine 100 μg ml -1  according to the practice of the anaesthetist, either prophylactically or therapeutically, as an infusion or bolus. The primary outcome was umbilical arterial pH with a chosen non-inferiority margin of 0.01 units.
RESULTS


Of 664 subjects (531 elective and 133 non-elective) who completed the study, umbilical arterial cord blood was analysed for 351 samples from 332 subjects in the norepinephrine group and 343 samples from 332 subjects in the phenylephrine group. Umbilical arterial pH was non-inferior in the norepinephrine group (mean, 7.289; 95% confidence interval [CI], 7.284-7.294) compared with the phenylephrine group (mean, 7.287; 95% CI, 7.281-7.292) (mean difference between groups, 0.002; 95% CI, -0.005 to 0.009; P=0.017). Subgroup analysis confirmed the non-inferiority of norepinephrine for elective cases but was inconclusive for non-elective cases.
CONCLUSIONS


Norepinephrine was non-inferior to phenylephrine for neonatal outcome assessed by umbilical arterial pH. These results provide high-quality evidence supporting the fetal safety of norepinephrine in obstetric anaesthesia.
CLINICAL TRIAL REGISTRATION


ChiCTR-IPR-15006235.",2020,"Umbilical arterial pH was non-inferior in the norepinephrine group (mean, 7.289; 95% confidence interval [CI], 7.284-7.294) compared with the phenylephrine group (mean, 7.287; 95% CI, 7.281-7.292) (mean difference between groups, 0.002; 95% CI, -0.005 to 0.009; P=0.017).","['664 subjects (531 elective and 133 non-elective) who completed the study', '332 subjects in the norepinephrine group and 343 samples from 332 subjects in the phenylephrine group', '668 subjects having elective and non', 'spinal anaesthesia for Caesarean delivery']","['phenylephrine', 'norepinephrine 6 μg ml -1  or phenylephrine', 'Norepinephrine', 'elective Caesarean delivery under spinal or combined spinal-epidural anaesthesia', 'Norepinephrine or phenylephrine', 'norepinephrine']","['umbilical arterial pH with a chosen non-inferiority margin of 0.01 units', 'Arterial blood pressure', 'umbilical arterial cord blood', 'Umbilical arterial pH']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C2744579', 'cui_str': 'ATP8A2 protein, human'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}]","[{'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}]",668.0,0.630435,"Umbilical arterial pH was non-inferior in the norepinephrine group (mean, 7.289; 95% confidence interval [CI], 7.284-7.294) compared with the phenylephrine group (mean, 7.287; 95% CI, 7.281-7.292) (mean difference between groups, 0.002; 95% CI, -0.005 to 0.009; P=0.017).","[{'ForeName': 'Warwick D', 'Initials': 'WD', 'LastName': 'Ngan Kee', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China; Department of Anesthesiology, Sidra Medicine, Doha, Qatar. Electronic address: wngankee@gmail.com.'}, {'ForeName': 'Shara W Y', 'Initials': 'SWY', 'LastName': 'Lee', 'Affiliation': 'Department of Health Technology & Informatics, Hong Kong Polytechnic University, Kowloon, Hong Kong, China.'}, {'ForeName': 'Floria F', 'Initials': 'FF', 'LastName': 'Ng', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.057']
1499,32690472,Brain delivery of supplemental docosahexaenoic acid (DHA): A randomized placebo-controlled clinical trial.,"BACKGROUND


Past clinical trials of docosahexaenoic Acid (DHA) supplements for the prevention of Alzheimer's disease (AD) dementia have used lower doses and have been largely negative. We hypothesized that larger doses of DHA are needed for adequate brain bioavailability and that APOE4 is associated with reduced delivery of DHA and eicosapentaenoic acid (EPA) to the brain before the onset of cognitive impairment.
METHODS


33 individuals were provided with a vitamin B complex (1 mg vitamin B12, 100 mg of vitamin B6 and 800 mcg of folic acid per day) and randomized to 2,152 mg of DHA per day or placebo over 6 months. 26 individuals completed both lumbar punctures and MRIs, and 29 completed cognitive assessments at baseline and 6 months. The primary outcome was the change in CSF DHA. Secondary outcomes included changes in CSF EPA levels, MRI hippocampal volume and entorhinal thickness; exploratory outcomes were measures of cognition.
FINDINGS


A 28% increase in CSF DHA and 43% increase in CSF EPA were observed in the DHA treatment arm compared to placebo (mean difference for DHA (95% CI): 0.08 µg/mL (0.05, 0.10), p<0.0001; mean difference for EPA: 0.008 µg/mL (0.004, 0.011), p<0.0001). The increase in CSF EPA in non-APOE4 carriers after supplementation was three times greater than APOE4 carriers. The change in brain volumes and cognitive scores did not differ between groups.
INTERPRETATION


Dementia prevention trials using omega-3 supplementation doses equal or lower to 1 g per day may have reduced brain effects, particularly in APOE4 carriers.
TRIAL REGISTRATION


NCT02541929.
FUNDING


HNY was supported by R01AG055770, R01AG054434, R01AG067063 from the National Institute of Aging and NIRG-15-361854 from the Alzheimer's Association, and MGH by the L. K. Whittier Foundation. This work was also supported by P50AG05142 (HCC) from the National Institutes of Health. Funders had no role in study design, data collection, data analysis, interpretation, or writing of the report.",2020,"The change in brain volumes and cognitive scores did not differ between groups.
","[""Alzheimer's disease (AD) dementia"", '26 individuals completed both lumbar punctures and MRIs, and 29 completed cognitive assessments at baseline and 6 months', '33 individuals']","['docosahexaenoic Acid (DHA) supplements', 'supplemental docosahexaenoic acid (DHA', 'vitamin B complex (1\xa0mg vitamin B12, 100\xa0mg of vitamin B6 and 800 mcg of folic acid per day) and randomized to 2,152 mg of DHA per day or placebo', 'placebo']","['change in brain volumes and cognitive scores', 'CSF DHA', 'change in CSF DHA', 'CSF EPA', 'changes in CSF EPA levels, MRI hippocampal volume and entorhinal thickness; exploratory outcomes were measures of cognition']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",33.0,0.602306,"The change in brain volumes and cognitive scores did not differ between groups.
","[{'ForeName': 'Isabella C', 'Initials': 'IC', 'LastName': 'Arellanes', 'Affiliation': 'Department of Medicine, Keck School of Medicine USC, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Choe', 'Affiliation': 'Department of Medicine, Keck School of Medicine USC, United States.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Solomon', 'Affiliation': 'Department of Medicine, Keck School of Medicine USC, United States.'}, {'ForeName': 'Xulei', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Medicine, Keck School of Medicine USC, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kavin', 'Affiliation': 'Department of Medicine, Keck School of Medicine USC, United States.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Martinez', 'Affiliation': 'Department of Medicine, Keck School of Medicine USC, United States.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kono', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine USC, United States.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Buennagel', 'Affiliation': 'Huntington Medical Research Institutes, CA, United States.'}, {'ForeName': 'Nalini', 'Initials': 'N', 'LastName': 'Hazra', 'Affiliation': 'Imaging Genetics Center, Stevens Neuroimaging and Informatics Institute, Keck School of Medicine, USC, United States.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Imaging Genetics Center, Stevens Neuroimaging and Informatics Institute, Keck School of Medicine, USC, United States.'}, {'ForeName': 'Lina M', 'Initials': 'LM', 'LastName': ""D'Orazio"", 'Affiliation': 'Department of Neurology, Keck School of Medicine USC, United States.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'McCleary', 'Affiliation': 'Department of Neurology, Keck School of Medicine USC, United States.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Sagare', 'Affiliation': 'Department of Physiology and Neuroscience, Keck School of Medicine USC, United States.'}, {'ForeName': 'Berislav V', 'Initials': 'BV', 'LastName': 'Zlokovic', 'Affiliation': 'Department of Physiology and Neuroscience, Keck School of Medicine USC, United States.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Department of Medicine, Keck School of Medicine USC, United States; Department of Preventive Medicine, Keck School of Medicine USC, United States.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine USC, United States.'}, {'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Chui', 'Affiliation': 'Department of Neurology, Keck School of Medicine USC, United States.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Harrington', 'Affiliation': 'Huntington Medical Research Institutes, CA, United States; Department of Neurology, Keck School of Medicine USC, United States.'}, {'ForeName': 'Meredith N', 'Initials': 'MN', 'LastName': 'Braskie', 'Affiliation': 'Imaging Genetics Center, Stevens Neuroimaging and Informatics Institute, Keck School of Medicine, USC, United States.'}, {'ForeName': 'Lon S', 'Initials': 'LS', 'LastName': 'Schneider', 'Affiliation': 'Department of Neurology, Keck School of Medicine USC, United States; Department of Psychiatry and the Behavioral Sciences, Keck School of Medicine USC, United States.'}, {'ForeName': 'Hussein N', 'Initials': 'HN', 'LastName': 'Yassine', 'Affiliation': 'Department of Medicine, Keck School of Medicine USC, United States; Department of Neurology, Keck School of Medicine USC, United States. Electronic address: hyassine@usc.edu.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102883']
1500,32691455,Cocreated internet-based stepped care for individuals with cancer and concurrent symptoms of anxiety and depression: Results from the U-CARE AdultCan randomized controlled trial.,"OBJECTIVE


The aim was to evaluate the effects of cocreated internet-based stepped care (iCAN-DO) on anxiety, depression, posttraumatic stress, and health-related quality of life (HRQoL) in individuals with cancer and self-reported anxiety and/or depression symptoms, compared with standard care.
METHODS


Clinically recruited individuals with breast, colorectal, or prostate cancer underwent online screening with the Hospital Anxiety and Depression Scale (HADS). Those with anxiety and/or depression symptoms (>7 on any of the HADS subscales) were randomized to iCAN-DO or standard care. iCAN-DO comprised psychoeducation and self-care strategies (step 1) and internet-based cognitive behavioral therapy (iCBT, step 2). Data were collected before randomization and at 1, 4, 7, and 10 months and analyzed with intention-to-treat regression analysis and randomization tests.
RESULTS


Online screening identified 245 (27%) of 909 individuals who reported anxiety and/or depression symptoms. They were randomized to iCAN-DO (n  = 124) or standard care (n = 121). Of them 49% completed the 10-month assessment, and in the iCAN-DO group 85% accessed step 1 and 13% underwent iCBT. iCAN-DO decreased the levels of symptoms of depression (-0.54, 95% confidence interval: -1.08 to -0.01, P < .05) and the proportion of individuals with symptoms of depression (P < .01) at 10 months, compared with standard care, according to HADS. There were no significant effects on anxiety, posttraumatic stress, or HRQoL.
CONCLUSION


Internet-based stepped care improves symptoms of depression in individuals with cancer. Further studies are needed to gain knowledge on how to optimize and implement internet-based support in oncology care.",2020,,['Individuals with Cancer and Concurrent Symptoms of Anxiety and Depression'],['Co-created Internet-based Stepped Care'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",[],,0.108249,,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hauffman', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Section of Experimental and Clinical Oncology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Alfonsson', 'Affiliation': ""Department of Women's and Children's Health, Section of Clinical Psychology in Healthcare, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bill-Axelson', 'Affiliation': 'Department of Surgical Sciences, Section of Urology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Bergkvist', 'Affiliation': 'Centre for Clinical Research, Uppsala University, Västmanland County Hospital, Västerås, Sweden.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Forslund', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Section of Experimental and Clinical Oncology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Mattsson', 'Affiliation': 'Department of Public Health and Caring Sciences, Lifestyle and Rehabilitation in Long-Term Illness, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'von Essen', 'Affiliation': ""Department of Women's and Children's Health, Section of Clinical Psychology in Healthcare, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nygren', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Section of Experimental and Clinical Oncology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Igelström', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Section of Experimental and Clinical Oncology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Johansson', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Section of Experimental and Clinical Oncology, Uppsala University, Uppsala, Sweden.'}]",Psycho-oncology,['10.1002/pon.5489']
1501,32697018,Food supplements and diet as treatment options in irritable bowel syndrome.,"Irritable bowel syndrome (IBS) is a chronic functional bowel disorder affecting 5.7% of the general population. Most patients relate their symptoms of IBS to foods they consume with diet being the most frequently reported factor impacting their life. However, although some foods may trigger symptoms, others may provide symptom relief. Indeed, several foods and diets have been investigated for their effectiveness in relieving IBS symptoms. In this issue of Neurogastroenterology and Motility, a double-blind randomized placebo-controlled trial in 160 patients with IBS demonstrated Aloe vera not to be effective in improving IBS symptoms. The aim of this review is to discuss the evidence on the effect of food supplements and diets in the management of IBS. Specifically, this review examines the evidence for aloe vera, peppermint oil, probiotics, fiber and prebiotics, healthy eating, the low FODMAP diet, and the gluten-free diet.",2020,Most patients relate their symptoms of IBS to foods they consume with diet being the most frequently reported factor impacting their life.,"['irritable bowel syndrome', '160 patients with IBS demonstrated Aloe vera not to be effective in improving IBS symptoms']","['food supplements and diets', 'Food supplements and diet', 'placebo']",['Irritable bowel syndrome (IBS'],"[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0718405', 'cui_str': 'Aloe vera'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}]",160.0,0.0704266,Most patients relate their symptoms of IBS to foods they consume with diet being the most frequently reported factor impacting their life.,"[{'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Dimidi', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13951']
1502,32693116,Topical therapy with rhubarb navel plasters in patients with chronic constipation: Results from a prospective randomized multicenter study.,"ETHNOPHARMACOLOGICAL RELEVANCE


Constipation is a functional gastrointestinal disorder and one of the most prevalent conditions encountered in primary care settings. Rhubarb navel dressings have been used for more than 2,000 years in Chinese medicine to treat constipation. However, the effect of topical rhubarb administration has still not been well recognized and this strategy is not yet established as an evidence-based approach.
AIM OF THE STUDY


In this study, we performed a prospective multicentric randomized controlled trial to evaluate the efficacy and safety of rhubarb navel plasters for patients with chronic constipation.
MATERIALS AND METHODS


A total of 374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria. All participants were randomly assigned (1:1) into verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick on the navel for 6 h/day/8 days. Primary outcome measures were the Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24 h defecation frequency.
RESULTS


The groups demonstrated no statistical differences in demographic data, clinical diagnoses and concomitant medication at baseline. In patients treated with the verum CCS was 5.61 (day 8, 95% CI 5.15-6.07) compared to 8.62 (95% CI 8.07-9.18) in placebo-treated controls (P < 0.001). The mean change of CCS at the end of treatment (day 8 versus [vs] day 0) was 6.04 in verum-treated vs 2.73 in placebo-treated controls (P < 0.001). Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05). No significant differences in adverse events between both groups became obvious.
CONCLUSION


Rhubarb navel plaster administration over an 8-day-treatment period resulted in significantly improved bowel function as demonstrated by the CCS, 24 h defecating frequency and BSS. Our results suggest that rhubarb navel plasters represent a feasible, safe and efficient application route for the treatment of patients suffering from chronic constipation.",2020,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","['patients with chronic constipation', 'patients suffering from chronic constipation', '374 patients from six teaching hospitals were prospectively included between 09/2016 and 10/2017 in the study based on Rome III criteria']","['verum/placebo group and given either Rheum officinale rhubarb powder or a placebo flour stick', 'Rhubarb navel dressings', 'Topical therapy', 'rhubarb navel plasters', 'verum CCS']","['demographic data, clinical diagnoses and concomitant medication', 'bowel function', 'BSS type classification', 'efficacy and safety', 'adverse events', 'defecation frequency (BSS', 'Cleveland Constipation Score (CCS) for the feces condition and Bristol Stool Scale (BSS) for stool consistency and 24\u202fh defecation frequency', 'mean change of CCS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0035509', 'cui_str': 'Rhubarb'}, {'cui': 'C1815861', 'cui_str': 'Rhubarb powder'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0457570', 'cui_str': 'Scale type'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0454845', 'cui_str': 'Cleveland'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",374.0,0.207116,"Also 24 h defecation frequency (BSS) showed superior results (day 5: 0.84 vs 0.62, 95% CI 0.67-0.80, P < 0.001; day 6: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01 and day 8: 0.82 vs 0.60, 95% CI 0.64-0.78, P < 0.01) and better BSS type classification during treatment than controls (P < 0.05).","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: weilin22@126.com.'}, {'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China. Electronic address: 314851488@qq.com.'}, {'ForeName': 'Xiaopei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: xingyunxing021@163.com.'}, {'ForeName': 'Yangchen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: morning924@126.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gasser', 'Affiliation': 'University of Wuerzburg, Wuerzburg, Germany. Electronic address: gasser_m@t-online.de.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: tangtang56love@126.com.'}, {'ForeName': 'Wen-Wei', 'Initials': 'WW', 'LastName': 'Ouyang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: yudexin1984@163.com.'}, {'ForeName': 'Hengqiu', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: 1131968978@qq.com.'}, {'ForeName': 'Shengzhen', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Jiangxi Integrated Traditional Chinese and Western Medicine Hospital, Nanchang, China. Electronic address: 982121880@qq.com.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Nanchang, China. Electronic address: 64243156@qq.com.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Waaga-Gasser', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: awaaga@bwh.harvard.edu.""}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Guangzhou University of Traditional Chinese Medicine, Guangzhou, China. Electronic address: gzdtcm@gzucm.edu.cn.'}, {'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.. Electronic address: linmeizhen@gzucm.edu.cn.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113096']
1503,32693197,"Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve.","Vitamin K antagonists are the only approved oral anticoagulants for long-term prophylaxis against valve thrombosis and thromboembolism in patients with a mechanical heart valve. Despite the proven efficacy and safety of anticoagulation with the oral direct factor Xa inhibitor apixaban compared with warfarin in high-risk populations including subjects with atrial fibrillation or with venous thromboembolism, it remains unknown whether patients with a mechanical heart valve can be safely managed with apixaban. The On-X Aortic Heart Valve and On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft may have lower rates of valve thrombosis and thromboembolism than conventional bileaflet and tilting disc valves due its unique pyrolytic carbon composition and flared inlet design. DESIGN: PROACT Xa is a randomized, multicenter, open-label, active-controlled trial comparing apixaban with warfarin in patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft. The study will randomize approximately 1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3 months prior. Patients will be randomized 1:1 to receiving apixaban 5 mg twice daily or warfarin with a target international normalized ratio of 2.0-3.0. The last randomized participant will be followed for at least 2 years. The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding. Assuming the primary outcome occurs in warfarin-anticoagulated patients at a rate of 1.75%/patient-year, the study has more than 90% power to assess noninferiority of apixaban treatment with an absolute noninferiority margin of 1.75%/patient-year. A second co-primary analysis is to compare the hazard rate for the apixaban arm to twice the objective performance criterion for thromboembolism and valve thrombosis, that is, 3.4%/patient-year. SUMMARY: PROACT Xa will determine whether patients with an On-X Aortic Heart Valve can be anticoagulated with apixaban as an alternative to warfarin.",2020,"The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding.","['patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft', 'subjects with atrial fibrillation or with venous thromboembolism', '1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3\u202fmonths prior', 'patients with a mechanical heart valve', 'patients with a mechanical On-X Aortic Heart Valve']","['PROACT Xa', 'apixaban 5\u202fmg twice daily or warfarin', 'apixaban versus warfarin', 'apixaban', 'warfarin', 'Vitamin K antagonists', 'apixaban with warfarin']","['efficacy and safety', 'composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding', 'hazard rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018829', 'cui_str': 'Prosthetic heart'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C3530472', 'cui_str': 'apixaban 5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0697264,"The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding.","[{'ForeName': 'Oliver K', 'Initials': 'OK', 'LastName': 'Jawitz', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Department of Surgery, Duke University Medical Center, Durham, NC. Electronic address: oliver.jawitz@duke.edu.'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Chavez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Brittanny', 'Initials': 'B', 'LastName': 'Boyer', 'Affiliation': 'CryoLife, Inc., Kennesaw, GA.'}, {'ForeName': 'Hwasoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Becker', 'Affiliation': 'Division of Cardiovascular Health and Diseases, University of Cincinnati Heart, Lung & Vascular Institute, Cincinnati, OH.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Blackstone', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Department of Cardiovascular Surgery, Mount Sinai St. Luke's, New York, NY.""}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Gerdisch', 'Affiliation': 'Department of Cardiothoracic Surgery, Franciscan Hospital, Indianapolis, IN.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Johnston', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Capps', 'Affiliation': 'CryoLife, Inc., Kennesaw, GA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Lars G', 'Initials': 'LG', 'LastName': 'Svensson', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}]",American heart journal,['10.1016/j.ahj.2020.06.014']
1504,32699906,"Effects of MOPP Gear on SAM Medical Junctional Tourniquet Application: A Prospective, Randomized Control Trial.","INTRODUCTION


Hemorrhage is the leading cause of preventable death on the battlefield, and hemostasis is particularly challenging to achieve at junctional sites such as the axillary or inguinal regions. Mission-oriented protective posture (MOPP) gear, as worn most recently in Syria to guard against chemical weapons, can make the performance of technical skills more challenging still. The objective of this study was to evaluate how wearing MOPP gear affects the application time of the SAM Medical Junctional Tourniquet (SJT) by U.S. Army combat medics.
MATERIALS AND METHODS


We conducted a prospective, randomized control trial evaluating time for SJT application between participants wearing MOPP versus those not wearing MOPP. Secondary outcomes included SJT application success rate and participant appraisal of SJT application difficulty assessed with five-point Likert items, between groups. Participants placed SJTs on robotic simulation mannequins with a penetrating inguinal injury.
RESULTS


In April 2019, we enrolled 49 combat medics. Most participants were male (77.5%), had a median age of 25 (interquartile range 23-28), and in the grade of E4 or less (63.3%). Mean SJT application times in seconds were higher among those wearing MOPP versus those who were not (223.1 versus 167.2; 95% confidence interval for difference in means 5.293, 106.374; P = 0.03). Participants wearing MOPP had a less successful application rate overall, but this difference was not statistically significant (64.3% versus 81.0%, P = 0.34). Compared to participants not wearing MOPP, those wearing MOPP agreed that SJT application was difficult (4 versus 3, P = 0.03), what they were wearing affected SJT application (4 versus 2, P = 0.01), and it was difficult to use their hands during SJT application (4 versus 1, P < 0.001).
CONCLUSIONS


Wearing military MOPP gear significantly prolongs the amount of time required for combat medics to apply an SJT on a simulated casualty with a penetrating inguinal injury. This study highlights the importance of incorporating MOPP gear into medical training scenarios to improve skills competency while wearing these protective garments.",2020,"Participants wearing MOPP had a less successful application rate overall, but this difference was not statistically significant (64.3% versus 81.0%, P = 0.34).","['SAM Medical Junctional Tourniquet Application', 'participants wearing MOPP versus those not wearing MOPP', 'Most participants were male (77.5%), had a median age of 25 (interquartile range 23-28), and in the grade of E4 or less (63.3']","['SAM Medical Junctional Tourniquet (SJT', 'MOPP Gear', 'Mission-oriented protective posture (MOPP']","['SJT application success rate and participant appraisal of SJT application difficulty assessed with five-point Likert items', 'Mean SJT application times', 'successful application rate overall']","[{'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]","[{'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.084364,"Participants wearing MOPP had a less successful application rate overall, but this difference was not statistically significant (64.3% versus 81.0%, P = 0.34).","[{'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Wagner', 'Affiliation': 'Madigan Army Medical Center, 9040A Jackson Ave, Joint Base Lewis-McChord, Tacoma, WA 98431.'}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Naylor', 'Affiliation': 'Madigan Army Medical Center, 9040A Jackson Ave, Joint Base Lewis-McChord, Tacoma, WA 98431.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Ahern', 'Affiliation': 'Madigan Army Medical Center, 9040A Jackson Ave, Joint Base Lewis-McChord, Tacoma, WA 98431.'}, {'ForeName': 'Brett C', 'Initials': 'BC', 'LastName': 'Gendron', 'Affiliation': 'Brooke Army Medical Center, 3551 Roger Brooke Dr, Joint Base San Antonio-Fort Sam Houston, TX 78234.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'April', 'Affiliation': 'Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Schauer', 'Affiliation': 'Brooke Army Medical Center, 3551 Roger Brooke Dr, Joint Base San Antonio-Fort Sam Houston, TX 78234.'}]",Military medicine,['10.1093/milmed/usaa138']
1505,32702299,"Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


This is the first randomised controlled trial for assessment of the immunogenicity and safety of a candidate non-replicating adenovirus type-5 (Ad5)-vectored COVID-19 vaccine, aiming to determine an appropriate dose of the candidate vaccine for an efficacy study.
METHODS


This randomised, double-blind, placebo-controlled, phase 2 trial of the Ad5-vectored COVID-19 vaccine was done in a single centre in Wuhan, China. Healthy adults aged 18 years or older, who were HIV-negative and previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-free, were eligible to participate and were randomly assigned to receive the vaccine at a dose of 1 × 10 11  viral particles per mL or 5 × 10 10  viral particles per mL, or placebo. Investigators allocated participants at a ratio of 2:1:1 to receive a single injection intramuscularly in the arm. The randomisation list (block size 4) was generated by an independent statistician. Participants, investigators, and staff undertaking laboratory analyses were masked to group allocation. The primary endpoints for immunogenicity were the geometric mean titres (GMTs) of specific ELISA antibody responses to the receptor binding domain (RBD) and neutralising antibody responses at day 28. The primary endpoint for safety evaluation was the incidence of adverse reactions within 14 days. All recruited participants who received at least one dose were included in the primary and safety analyses. This study is registered with ClinicalTrials.gov, NCT04341389.
FINDINGS


603 volunteers were recruited and screened for eligibility between April 11 and 16, 2020. 508 eligible participants (50% male; mean age 39·7 years, SD 12·5) consented to participate in the trial and were randomly assigned to receive the vaccine (1 × 10 11  viral particles n=253; 5 × 10 10  viral particles n=129) or placebo (n=126). In the 1 × 10 11  and 5 × 10 10  viral particles dose groups, the RBD-specific ELISA antibodies peaked at 656·5 (95% CI 575·2-749·2) and 571·0 (467·6-697·3), with seroconversion rates at 96% (95% CI 93-98) and 97% (92-99), respectively, at day 28. Both doses of the vaccine induced significant neutralising antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8-22·7) and 18·3 (14·4-23·3) in participants receiving 1 × 10 11  and 5 × 10 10  viral particles, respectively. Specific interferon γ enzyme-linked immunospot assay responses post vaccination were observed in 227 (90%, 95% CI 85-93) of 253 and 113 (88%, 81-92) of 129 participants in the 1 × 10 11  and 5 × 10 10  viral particles dose groups, respectively. Solicited adverse reactions were reported by 183 (72%) of 253 and 96 (74%) of 129 participants in the 1 × 10 11  and 5 × 10 10  viral particles dose groups, respectively. Severe adverse reactions were reported by 24 (9%) participants in the 1 × 10 11  viral particles dose group and one (1%) participant in the 5 × 10 10  viral particles dose group. No serious adverse reactions were documented.
INTERPRETATION


The Ad5-vectored COVID-19 vaccine at 5 × 10 10  viral particles is safe, and induced significant immune responses in the majority of recipients after a single immunisation.
FUNDING


National Key R&D Programme of China, National Science and Technology Major Project, and CanSino Biologics.",2020,"Both doses of the vaccine induced significant neutralising antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8-22·7) and 18·3 (14·4-23·3) in participants receiving 1 × 10 11  and 5 × 10 10  viral particles, respectively.","['single centre in Wuhan, China', 'healthy adults aged 18 years or older', '508 eligible participants (50% male; mean age 39·7 years, SD 12·5) consented to participate in the trial', 'Healthy adults aged 18 years or older, who were HIV-negative and previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-free, were eligible to participate', '603 volunteers were recruited and screened for eligibility between April 11 and 16, 2020', 'All recruited participants who received at least one dose were included in the primary and safety analyses']","['recombinant adenovirus type-5-vectored', 'vaccine at a dose of 1\u2008×\u200810 11  viral particles per mL or 5\u2008×\u200810 10  viral particles per mL, or placebo', 'Ad5-vectored COVID-19 vaccine', 'vaccine', 'COVID-19 vaccine', 'placebo']","['serious adverse reactions', 'Specific interferon γ enzyme-linked immunospot assay responses post vaccination', 'Severe adverse reactions', 'seroconversion rates', 'incidence of adverse reactions', 'geometric mean titres (GMTs) of specific ELISA antibody responses to the receptor binding domain (RBD) and neutralising antibody responses', 'Solicited adverse reactions', 'Immunogenicity and safety', 'RBD-specific ELISA antibodies']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",508.0,0.652323,"Both doses of the vaccine induced significant neutralising antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8-22·7) and 18·3 (14·4-23·3) in participants receiving 1 × 10 11  and 5 × 10 10  viral particles, respectively.","[{'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China. Electronic address: jszfc@vip.sina.com.'}, {'ForeName': 'Xu-Hua', 'Initials': 'XH', 'LastName': 'Guan', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Yu-Hua', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Jian-Ying', 'Initials': 'JY', 'LastName': 'Huang', 'Affiliation': 'Clinical Trial Center, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Hou', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Jing-Xin', 'Initials': 'JX', 'LastName': 'Li', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Bei-Fang', 'Initials': 'BF', 'LastName': 'Yang', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Wen-Juan', 'Initials': 'WJ', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Shi-Po', 'Initials': 'SP', 'LastName': 'Wu', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Wu', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Xu', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Si-Yue', 'Initials': 'SY', 'LastName': 'Jia', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Bu-Sen', 'Initials': 'BS', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, China.'}, {'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiao-Ai', 'Initials': 'XA', 'LastName': 'Qian', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Pan', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Hu-Dachuan', 'Initials': 'HD', 'LastName': 'Jiang', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Deng', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Jin-Bo', 'Initials': 'JB', 'LastName': 'Gou', 'Affiliation': 'CanSino Biologics, Tianjin, China.'}, {'ForeName': 'Xue-Wen', 'Initials': 'XW', 'LastName': 'Wang', 'Affiliation': 'Shanghai Canming Medical Technology, Shanghai, China.'}, {'ForeName': 'Xing-Huan', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Clinical Trial Center, Zhongnan Hospital of Wuhan University, Wuhan, China. Electronic address: wangxinghuan@whu.edu.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China. Electronic address: cw0226@foxmail.com.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31605-6']
1506,32708600,Impact of Exercises and Chair Massage on Musculoskeletal Pain of Young Musicians.,"Due to the occurrence among musicians of musculoskeletal problems associated with playing a musical instrument, it is necessary to use prophylaxis. The aim of the study was to compare the effectiveness of two physioprophylaxis methods: chair massage and an original set of exercises. The study lasted four weeks and consisted of eight 15-min meetings (chair massage/exercises). The study was conducted on 44 music students assigned to three groups (chair massage/exercise program/control group). The algometric measurements and questionnaire were conducted. Health problems associated with playing an instrument was reported by 86.4% of the participants. The largest changes in pain threshold concerned the trigger points of the muscles with the highest pain sensitivity, i.e., upper part of trapezius ones, and reached 25-34% in relation to the initial values. For the trigger points of the levator scapulae and lower part of trapezius, the increase in the pain threshold was between 20 and 28%. Raising the pain threshold was observed both after each session and meeting by meeting, and these differences were most visible in the massage group. This effect was particularly visible from the fourth treatment. Chair massage and exercise should be used regularly, and significant results can be obtained after two weeks.",2020,"For the trigger points of the levator scapulae and lower part of trapezius, the increase in the pain threshold was between 20 and 28%.","['44 music students assigned to three groups ', 'Musculoskeletal Pain of Young Musicians']","['Exercises and Chair Massage', 'physioprophylaxis methods: chair massage', 'Chair massage and exercise', 'chair massage/exercise program/control group']",['pain threshold'],"[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",44.0,0.0195533,"For the trigger points of the levator scapulae and lower part of trapezius, the increase in the pain threshold was between 20 and 28%.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cygańska', 'Affiliation': 'Faculty of Rehabilitation, Józef Piłsudski University of Physical Education in Warsaw, Poland, Marymoncka 34, 00-968 Warsaw, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Truszczyńska-Baszak', 'Affiliation': 'Faculty of Rehabilitation, Józef Piłsudski University of Physical Education in Warsaw, Poland, Marymoncka 34, 00-968 Warsaw, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Tomaszewski', 'Affiliation': 'Faculty of Physical Education, Józef Piłsudski University of Physical Education in Warsaw, Poland, Marymoncka 34, 00-968 Warsaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17145128']
1507,32709513,Three-Dimensional Spinal Position With and Without Manual Distraction Load Increases Spinal Height.,"OBJECTIVE


The purpose of this study was to investigate if spinal height increases using 3-dimensional (3-D) spinal position with and without manual distraction load and to assess the correlation between spine height changes and degrees of trunk rotation.
METHODS


Fifty-six participants were randomly placed in one of two groups: (1) 3-D spinal position with manual distraction load, and (2) without manual distraction load. Spinal height was measured before and after the interventions using a stadiometer. For the statistical analysis, we used a 2 (Loading status: pre- versus post-intervention height) X 2 (3-D spinal position: with versus without manual distraction load) repeated measures Analysis of Variance (ANOVA) was used to identify significant interaction and main effects. Paired t-tests were used to calculate differences in spinal height changes between the two interventions. Pearson correlation coefficient was used to measure correlations between changes in spinal heights and degrees of trunk rotation.
RESULTS


Mean spinal height increase with 3-D spinal position with and without manual distraction load was 6.30 mm (±6.22) and 5.69 mm (±4.13), respectively. No significant interaction effect was present between loading status and 3-D spinal position but a significant main effect in loading status was. Paired t-tests revealed significant differences in spinal heights between pre-and post-3-D spinal position with and without manual distraction load. No significant correlation was measured between trunk rotation and spinal height changes.
CONCLUSION


3-D spinal position with or without distraction load increased spinal height. This suggests that 3-D spinal positioning without manual distraction could be used in home settings to help maintain intervertebral disc (IVD) health.",2020,No significant interaction effect was present between loading status and 3-D spinal position but a significant main effect in loading status was.,['Fifty-six participants'],"['3-D spinal position with manual distraction load, and (2) without manual distraction load', '3-dimensional (3-D) spinal position with and without manual distraction load']","['Mean spinal height increase with 3-D spinal position', 'trunk rotation and spinal height changes', 'spinal heights and degrees of trunk rotation', 'spinal height changes', 'spinal heights', 'spinal height', 'Spinal height']",[],"[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0557899', 'cui_str': 'Height increased'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",56.0,0.0215252,No significant interaction effect was present between loading status and 3-D spinal position but a significant main effect in loading status was.,"[{'ForeName': 'Sohal S', 'Initials': 'SS', 'LastName': 'Hallur', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Brismée', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX. Electronic address: jm.brismee@ttuhsc.edu.'}, {'ForeName': 'Phillip S', 'Initials': 'PS', 'LastName': 'Sizer', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dierick', 'Affiliation': ""Centre National de R é education Fonctionnelle et de R éadaptation-Rehazenter, Laboratoire d'Analyse du Mouvement et de la Posture (LAMP), Luxembourg, Grand Duchy of Luxembourg.""}, {'ForeName': 'Birendra M', 'Initials': 'BM', 'LastName': 'Dewan', 'Affiliation': 'Center for Rehabilitation Research, School of Health Professions, Texas Tech University Health Sciences Center, Lubbock, TX.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thiry', 'Affiliation': 'Forme & Fonctionnement Humain Laboratory, Physical Therapy Department, CERISIC, Haute Ecole Louvain en Hainaut & Université Catholique de Louvain, Faculty of Motor Sciences, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Sobczak', 'Affiliation': ""Research Unit in Clinical and Functional Anatomy, Départment d'anatomie, Université du Québec à Trois-Rivières, Canada.""}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.04.007']
1508,32713395,Nocturnal whey protein ingestion impairs post-prandial glucose tolerance at breakfast.,"Poor post-prandial glucose control is a risk factor for multiple health conditions. The second-meal effect refers to the progressively improved glycaemic control with repeated feedings, an effect which is achievable with protein ingestion at the initial eating occasion. The most pronounced glycaemic response each day therefore typically occurs following breakfast, so the present study investigated whether ingesting protein during the night could improve glucose control at the first meal of the day. In a randomised crossover design, fifteen adults (seven males, eight females; age, 22 (sd 3) years; BMI, 24·0 (sd 2·8) kg/m2; fasting blood glucose, 4·9 (sd 0·5) mmol/l) woke at 04.00 (sd 1) hours to ingest 300 ml water with or without 63 g whey protein. Participants then completed a mixed-macronutrient meal tolerance test (1 g carbohydrate/kg body mass, 2356 (sd 435) kJ), 5 h 39 min following the nocturnal feeding. Nocturnal protein ingestion increased the glycaemic response (incremental AUC) to breakfast by 43·5 (sd 55·5) mmol × 120 min/l (P = 0·009, d = 0·94). Consistent with this effect, individual peak blood glucose concentrations were 0·6 (sd 1·0) mmol/l higher following breakfast when protein had been ingested (P = 0·049, d = 0·50). Immediately prior to breakfast, rates of lipid oxidation were 0·02 (sd 0·03) g/min higher (P = 0·045) in the protein condition, followed by an elevated post-prandial energy expenditure (0·38 (sd 0·50) kJ/min, P = 0·018). Post-prandial appetite and energy intake were similar between conditions. The present study reveals a paradoxical second-meal phenomenon whereby nocturnal whey protein feeding impaired subsequent glucose tolerance, whilst increasing post-prandial energy expenditure.",2020,"Nocturnal protein ingestion increased the glycaemic response (incremental area under curve) to breakfast by 43.5 ± 55.5 mmol•120 min•L-1 (p=0.009, d=0.94).","['fifteen adults (7 males, 8 females; age, 22 ± 3 years; BMI, 24.0 ± 2.8 kg·m-2; fasting blood glucose, 4.9 ± 0.5 mmol·L-1) woke at 0400 ± 1 h to ingest 300 ml water with or without 63 g whey protein']",['Nocturnal whey protein ingestion'],"['elevated postprandial energy expenditure', 'individual peak blood glucose concentrations', 'glycaemic response', 'postprandial glucose tolerance', 'Postprandial appetite and energy intake', 'rates of lipid oxidation', 'postprandial energy expenditure', 'subsequent glucose tolerance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",15.0,0.0144562,"Nocturnal protein ingestion increased the glycaemic response (incremental area under curve) to breakfast by 43.5 ± 55.5 mmol•120 min•L-1 (p=0.009, d=0.94).","[{'ForeName': 'Eleanor S', 'Initials': 'ES', 'LastName': 'Smith', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Adama', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Keeley', 'Initials': 'K', 'LastName': 'Clayton', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Holbrey', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Palubiski', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Smith', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}]",The British journal of nutrition,['10.1017/S0007114520002901']
1509,32717713,"Effect of lifetime antiepileptic drug treatment history on efficacy and tolerability of adjunctive brivaracetam in adults with focal seizures: Post-hoc analysis of a randomized, placebo-controlled trial.","OBJECTIVE


To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs).
METHODS


Post-hoc analysis of data from N01358 (NCT01261325), a randomized, double-blind, placebo (PBO)-controlled Phase III trial evaluating BRV 100 and 200 mg/day in patients ≥16 years of age with uncontrolled focal seizures. Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
RESULTS


764 patients received at least one dose of trial medication (BRV: 503; PBO: 261; Safety Set), of whom 14.3% had 1-2, 20.8% had 3-4, 21.3% had 5-6, and 43.6% had ≥7 lifetime AEDs. In all lifetime AED subgroups, >85% of patients completed the trial. Patients with a higher number of lifetime AEDs had a younger age at epilepsy onset, longer epilepsy duration, and higher baseline seizure frequency. In patients on BRV, 50% responder rates were 49.3%, 44.4%, 47.2% and 27.4% in patients with 1-2 (n = 75), 3-4 (n = 99), 5-6 (n = 108) and ≥7 (n = 219) lifetime AEDs; 75% responder rates were 36.0%, 21.2%, 22.2% and 12.3%. In patients on PBO, 50% responder rates were 35.3%, 25.9%, 20.4% and 15.9% in patients with 1-2 (n = 34), 3-4 (n = 58), 5-6 (n = 54) and ≥7 (n = 113) lifetime AEDs; 75% responder rates were 26.5%, 6.9%, 3.7% and 4.4%. The Kaplan-Meier estimated probability of patients achieving a sustained 50% or 75% response from the first day of treatment was generally higher in patients with a lower number of lifetime AEDs (both in patients on BRV and PBO). In patients on adjunctive BRV, the incidence of drug related treatment-emergent adverse events (TEAEs) was 34.7%, 26.0%, 44.4% and 47.7% in patients with 1-2 (n = 75), 3-4 (n = 100), 5-6 (n = 108) and ≥7 (n = 220) lifetime AEDs; the incidence of discontinuations due to TEAEs was 1.3%, 3.0%, 8.3% and 10.5%.
CONCLUSIONS


This post-hoc analysis suggests a numerically higher response to adjunctive BRV in patients with fewer lifetime AEDs. The lowest response was observed in patients with ≥7 lifetime AEDs, although these patients could also benefit from adjunctive BRV treatment. Patients with fewer lifetime AEDs had lower discontinuation of BRV due to TEAEs.",2020,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","['adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs', 'adults with focal seizures', 'subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs', 'patients ≥16 years of age with uncontrolled focal seizures']","['adjunctive brivaracetam (BRV', 'adjunctive brivaracetam', 'placebo']","['Efficacy and tolerability outcomes', 'responder rates', 'incidence of drug related treatment-emergent adverse events (TEAEs', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",764.0,0.103758,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Western University, 339 Windermere Road, London, ON N6A 5A5, Canada. Electronic address: rsmcl@uwo.ca.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Foris', 'Affiliation': 'UCB Pharma, 2060 Winston Park Drive, Suite 401, Oakville, ON L6H 5R7, Canada. Electronic address: kforis@sympatico.ca.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Nondonfaz', 'Affiliation': ""UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium. Electronic address: xavier.nondonfaz@ucb.com.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: svetlana.dimova@ucb.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106369']
1510,32720190,Effects of Therapeutic Intervention on Parentally Bereaved Children's Emotion Reactivity and Regulation 15 Years Later.,"The Family Bereavement Program (FBP) is a family-based intervention for parentally bereaved children and surviving caregivers. Results are reported of a randomized controlled trial, examining intervention effects on emotional reactivity and regulation of young adults who participated in the program 15 years earlier. Participants (N = 152) completed four emotion challenge tasks: reactivity to negative images, detached reappraisal while viewing negative images, positive reappraisal while viewing negative images, and reengagement with positive images. Outcomes included cardiac interbeat interval (IBI), pre-ejection period (PEP), and respiratory sinus arrhythmia (RSA) as well as self-reported emotional experience and regulation effectiveness. Direct intervention effects and effects mediated through improved parenting were estimated. Several significant effects were observed in primary analyses; however, none remained significant after correction for familywise Type I error. Parenting mediated FBP effects on IBI during negative reactivity (b = 15.04), and on RSA during positive reengagement (b = 0.35); the latter effect was accounted for by changes in breathing. Intervention condition was a direct predictor of self-reported detached reappraisal effectiveness (b = 1.00). Intervention and gender interacted in predicting self-reported negative emotion during the negative reactivity (b = 1.04) and positive reappraisal tasks (b = 1.31) such that intervention-condition men reported more negative emotions during those tasks. Although these findings should be considered preliminary given the limited power of the corrected statistical tests, they suggest long-term effects of family intervention following the death of a parent on offspring's emotional reactivity and regulation ability that should be pursued further in future research.",2020,Intervention condition was a direct predictor of self-reported detached reappraisal effectiveness (b = 1.00).,"['young adults who participated in the program 15\xa0years earlier', 'Participants (N\u2009=\u2009152) completed four', ""Parentally Bereaved Children's Emotion Reactivity and Regulation 15\xa0Years Later""]","['emotion challenge tasks: reactivity to negative images, detached reappraisal while viewing negative images, positive reappraisal while viewing negative images, and reengagement with positive images', 'Family Bereavement Program (FBP', 'Therapeutic Intervention']","['emotional reactivity and regulation', 'cardiac interbeat interval (IBI), pre-ejection period (PEP), and respiratory sinus arrhythmia (RSA) as well as self-reported emotional experience and regulation effectiveness', 'negative emotions', 'positive reappraisal tasks']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0860659', 'cui_str': 'Aloof'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0425043', 'cui_str': 'Death of relative'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0281621,Intervention condition was a direct predictor of self-reported detached reappraisal effectiveness (b = 1.00).,"[{'ForeName': 'Alexander F', 'Initials': 'AF', 'LastName': 'Danvers', 'Affiliation': 'Department of Psychology, University of Arizona, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Brandon G', 'Initials': 'BG', 'LastName': 'Scott', 'Affiliation': 'Department of Psychology, Montana State University, Culbertson Hall, 100, Bozeman, MT, 59717, USA.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Shiota', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA. lani.shiota@asu.edu.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA.'}, {'ForeName': 'Sharlene A', 'Initials': 'SA', 'LastName': 'Wolchik', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA.'}, {'ForeName': 'Irwin I', 'Initials': 'II', 'LastName': 'Sandler', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01142-2']
1511,32721815,Effect of intranasal oxytocin administration on self-other distinction: Modulations by psychological distance and gender.,"Preliminary evidence indicates that intranasal oxytocin (OT) administration modulates one's ability to distinguish oneself from others (i.e., self-other distinction). However, previous findings on this topic are contradictory. The current study addressed this issue by (i) using a novel perceptual matching task examining self-other distinction compared to both close and distant others, and (ii) tentatively exploring potential modulations by gender. In a double-blind, placebo-controlled, randomized OT administration study, 100 participants (50 males and 50 females) were randomized to receive intranasal spray of 24 IU OT or placebo (PL). Afterwards, participants completed a geometry perceptual matching task in which different shapes were paired to the self, a friend, or a stranger. Participants were then asked to judge whether each pair of shapes and labels was correctly matched. The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females. These findings provide insights for debates on the role of OT in self-other distinction by revealing modulations by psychological distance and gender, which have implications for the potential clinical applications of OT.",2020,"The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females.",['100 participants (50 males and 50 females'],"['intranasal spray of 24 IU OT or placebo (PL', 'intranasal oxytocin (OT', 'intranasal oxytocin', 'placebo']",[],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],100.0,0.104773,"The results revealed that compared to PL administration, OT facilitated distinction between the self and a friend in males but not in females.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, China; School of Psychology, Center for Studies of Psychological Application, and Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Xinmei', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Xiangru', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Institute of Cognition, Brain and Health, Institute of Psychology and Behavior, Henan University, Kaifeng, China.'}, {'ForeName': 'Ruida', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing, China.'}, {'ForeName': 'Shangfeng', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yue-Jia', 'Initials': 'YJ', 'LastName': 'Luo', 'Affiliation': 'Center of Brain Disorder and Cognitive Sciences, College of Psychology and Sociology, Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China. Electronic address: luoyj@szu.edu.cn.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104804']
1512,32690640,Safety and Pharmacokinetics of Recombinant Human Plasma Gelsolin in Patients Hospitalized for Nonsevere Community-Acquired Pneumonia.,"There remains an unmet need to address the substantial morbidity and mortality associated with severe community-acquired pneumonia (sCAP). Recombinant human plasma gelsolin (rhu-pGSN) improves disease outcomes in diverse animal models of infectious and noninfectious inflammation. This blinded dose-escalation safety study involved non-intensive care unit (ICU) patients admitted for mild CAP and randomized 3:1 to receive adjunctive rhu-pGSN or placebo intravenously. Thirty-three subjects were treated: 8 in the single-dose phase and 25 in the multidose phase. For the single-dose phase, rhu-pGSN at 6 mg/kg of body weight was administered once. For the multidose phase, a daily rhu-pGSN dose of 6, 12, or 24 mg/kg was given on 3 consecutive days. Adverse events (AEs) were generally mild in both treatment groups irrespective of dose. The only serious AE (SAE) in the single-dose phase was a non-drug-related pneumonia in a rhu-pGSN recipient who died after institution of comfort care. One single-dose placebo recipient had a drug-related AE (maculo-papular rash). In the multidose phase, there were 2 SAEs in 1 placebo recipient, including a fatal pulmonary embolism. In the 18 rhu-pGSN recipients in the multidose phase, there were no serious or drug-related AEs, and nausea and increased blood pressure were each reported in 2 patients. The median rhu-pGSN half-life exceeded 17 h with all dosing regimens, and supraphysiologic levels were maintained throughout the 24-h dosing interval in the 2 highest dosing arms. Rhu-pGSN was well tolerated overall in CAP patients admitted to non-ICU beds, justifying a larger proof-of-concept trial in an ICU population admitted with sCAP. (This study has been registered at ClinicalTrials.gov under identifier NCT03466073.).",2020,Recombinant human plasma gelsolin (rhu-pGSN) improves disease outcomes in diverse animal models of infectious and non-infectious inflammation.,"['Patients Hospitalized for Non-Severe Community-Acquired Pneumonia', 'Thirty-three subjects were treated: 8 in the single-dose phase and 25 in the multi-dose phase', 'non-ICU patients admitted for mild CAP']","['placebo', 'adjunctive rhu-pGSN or placebo', 'Recombinant human plasma gelsolin (rhu-pGSN', 'Recombinant Human Plasma Gelsolin']","['fatal pulmonary embolism', 'Adverse events (AEs', 'no serious or drug-related AEs, and nausea and increased blood pressure', 'supraphysiologic levels', 'median rhu-pGSN half-life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0949898', 'cui_str': 'Sumac'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0061187', 'cui_str': 'Gelsolin'}]","[{'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0949898', 'cui_str': 'Sumac'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",33.0,0.124056,Recombinant human plasma gelsolin (rhu-pGSN) improves disease outcomes in diverse animal models of infectious and non-infectious inflammation.,"[{'ForeName': 'Abla', 'Initials': 'A', 'LastName': 'Tannous', 'Affiliation': 'BioAegis Therapeutics, North Brunswick, New Jersey, USA atannous@bioaegistx.com.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Levinson', 'Affiliation': 'BioAegis Therapeutics, North Brunswick, New Jersey, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bolognese', 'Affiliation': 'Cytel Corporation, Waltham, Massachusetts, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Opal', 'Affiliation': 'Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'DiNubile', 'Affiliation': 'BioAegis Therapeutics, North Brunswick, New Jersey, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00579-20']
1513,32696033,"Subcutaneous administration of benzathine benzylpenicillin G has favourable pharmacokinetic characteristics for the prevention of rheumatic heart disease compared with intramuscular injection: a randomized, crossover, population pharmacokinetic study in healthy adult volunteers.","BACKGROUND


Benzathine penicillin G has been used as monthly deep intramuscular (IM) injections since the 1950s for secondary prevention of acute rheumatic fever and rheumatic heart disease (RHD). Injection frequency and pain are major programmatic barriers for adherence, prompting calls for development of better long-acting penicillin preparations to prevent RHD. We hypothesized that subcutaneous (SC) administration of benzathine penicillin G could delay penicillin absorption when compared with IM injections.
METHODS


To compare the pharmacokinetic profile and tolerability of benzathine penicillin G according to different routes of administration, 15 healthy males participated in a randomized crossover study to receive benzathine penicillin G by either SC or IM routes, with a 10 week washout period before the second dose by the alternative route. Ultrasound guidance confirmed injection location. Penicillin concentrations and pain scores were measured for 6 weeks following injections.
RESULTS


SC administration was well tolerated with no significant differences in pain scores. Following SC injection, the principal absorption half-life (95% CI) was 20.1 (16.3-29.5) days and 89.6% (87.1%-92.0%) of the drug was directed via this pathway compared with 10.2 (8.6-12.5) days and 71.3% (64.9%-77.4%) following IM administration. Lower peak and higher trough penicillin concentrations resulted following SC injection. Simulations demonstrated that SC infusion of higher doses of benzathine penicillin G could provide therapeutic penicillin concentrations for 3 months.
CONCLUSIONS


SC administration of benzathine penicillin G is safe and significantly delays penicillin absorption. High-dose benzathine penicillin G via the SC route would fulfil many product characteristics required for the next generation of longer-acting penicillins for use in RHD.",2020,"RESULTS


SC administration was well tolerated with no significant differences in pain scores.","['15 healthy males', 'healthy adult volunteers']","['benzathine benzylpenicillin G', 'Benzathine penicillin G', 'benzathine penicillin G']","['pain scores', 'Lower peak and higher trough penicillin concentrations', 'pharmacokinetic profile and tolerability', 'delay penicillin absorption', 'Penicillin concentrations and pain scores', 'therapeutic penicillin concentrations']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0030829', 'cui_str': 'benzathine benzylpenicillin'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",15.0,0.295838,"RESULTS


SC administration was well tolerated with no significant differences in pain scores.","[{'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Kado', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Salman', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Henderson', 'Affiliation': 'Department of Radiology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hand', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Wyber', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Page-Sharp', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin University, Bentley, Western Australia, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Batty', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin University, Bentley, Western Australia, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Manning', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa282']
1514,32700772,GLP-1 receptor agonists for Parkinson's disease.,"BACKGROUND


Parkinson's disease (PD) is a progressive disorder characterised by both motor and non-motor problems. Glucagon-like peptide-1 (GLP-1) receptor agonists, licensed for treatment of type 2 diabetes, work by stimulating GLP-1 receptors in the pancreas, which triggers the release of insulin. GLP-1 receptors have been found in the brain. Insulin signalling in the brain plays a key role in neuronal metabolism and repair and in synaptic efficacy, but insulin signalling is desensitised in the brain of people with PD. Researchers are exploring the neuroprotective effects of GLP-1 receptor agonists in neurodegenerative disorders such as PD.
OBJECTIVES


To evaluate the effectiveness and safety of GLP-1 receptor agonists for Parkinson's disease.
SEARCH METHODS


We searched the Cochrane Movement Disorders Group trials register; the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; and Ovid MEDLINE and Embase. We also searched clinical trials registries, and we handsearched conference abstracts. The most recent search was run on 25 June 2020.
SELECTION CRITERIA


We included randomised controlled trials (RCTs) of adults with PD that compared GLP-1 receptor agonists with conventional PD treatment, placebo, or no treatment.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed studies for inclusion, extracted data, and assessed risk of bias. We rated the quality of evidence using GRADE. We resolved discrepancies between the two data extractors by consultation with a third review author.
MAIN RESULTS


Through our searches, we retrieved 99 unique records, of which two met our inclusion criteria. One double-blind study of exenatide versus placebo randomised 62 participants, who self-administered exenatide or placebo for 48 weeks and were followed up at 60 weeks after a 12-week washout. One single-blind study of exenatide versus no additional treatment randomised 45 participants; participants in the intervention group self-administered exenatide for 12 months, and all participants were followed up at 14 months and 24 months following absence of exenatide for 2 months and 12 months, respectively. These trials had low risk of bias, except risk of performance bias was high for Aviles-Olmos 2013. Exenatide versus placebo Primary outcomes We found low-certainty evidence suggesting that exenatide improves motor impairment as assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III in the off-medication state (mean difference (MD) -3.10, 95% confidence interval (CI) -6.11 to -0.09). The difference in scores was slightly greater when scores were adjusted for baseline severity of the condition (as reported by study authors) (MD -3.5, 95% CI -6.7 to -0.3), exceeding the minimum clinically important difference (MCID). We found low-certainty evidence suggesting that exenatide has little or no effect on health-related quality of life (HRQoL) as assessed by the Parkinson's Disease Questionnaire (PDQ)-39 Summary Index (SI) (MD -1.80, 95% CI -6.95 to 3.35), the EuroQol scale measuring health status in five dimensions (EQ5D) (MD 0.07, 95% CI -0.03 to 0.16), or the EQ5D visual analogue scale (VAS) (MD 5.00, 95% CI -3.42 to 13.42). Eight serious adverse events (SAEs) were recorded, but all were considered unrelated to the intervention. Low-certainty evidence suggests that exenatide has little or no effect on weight loss (risk ratio (RR) 1.25, 95% CI 0.89 to 1.76). Exenatide versus no treatment Primary outcomes at 14 months We found very low-certainty evidence suggesting that exenatide improves motor impairment as assessed by MDS-UPDRS Part III off medication (MD -4.50, 95% CI -8.64 to -0.36), exceeding the MCID. We are uncertain whether exenatide improves HRQoL as assessed by the PDQ-39 SI (MD 3.50, 95% CI -2.75 to 9.75; very low-quality evidence). We found very low-certainty evidence suggesting that exenatide has little or no effect on the number of SAEs (RR 1.60, 95% 0.40 to 6.32). We found very low-certainty evidence suggesting that exenatide may lead to weight loss (MD -2.40 kg, 95% CI -4.56 to -0.24). Primary outcomes at 24 months We found evidence as reported by study authors to suggest that exenatide improves motor impairment as measured by MDS-UPDRS Part III off medication (MD 5.6 points, 95% CI 2.2 to 9.0). Exenatide may not improve HRQoL as assessed by the PDQ-39 SI (P = 0.682) and may not result in weight loss (MD 0.1 kg, 95% CI 3.0 to 2.8).
AUTHORS' CONCLUSIONS


Low- or very low-certainty evidence suggests that exenatide may improve motor impairment for people with PD. The difference in motor impairment observed between groups may persist for some time following cessation of exenatide. This raises the possibility that exenatide may have a disease-modifying effect. SAEs were unlikely to be related to treatment. The effectiveness of exenatide for improving HRQoL, non-motor outcomes, ADLs, and psychological outcomes is unclear. Ongoing studies are assessing other GLP-1 receptor agonists.",2020,"Exenatide may not improve HRQoL as assessed by the PDQ-39 SI (P = 0.682) and may not result in weight loss (MD 0.1 kg, 95% CI 3.0 to 2.8).
","[""Parkinson's disease"", 'adults with PD that compared', 'randomised 62 participants, who self-administered', 'people with PD', '45 participants']","['exenatide', 'Glucagon-like peptide-1', 'Exenatide', 'exenatide or placebo', 'GLP-1 receptor agonists', 'GLP-1 receptor agonists with conventional PD treatment, placebo, or no treatment', 'placebo']","['motor impairment', 'health-related quality of life (HRQoL', 'HRQoL', 'weight loss', ""Parkinson's Disease Questionnaire (PDQ)-39 Summary Index (SI"", ""Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'Eight serious adverse events (SAEs', 'EuroQol scale measuring health status', 'number of SAEs', 'MDS-UPDRS Part III off medication', 'EQ5D visual analogue scale (VAS']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.369049,"Exenatide may not improve HRQoL as assessed by the PDQ-39 SI (P = 0.682) and may not result in weight loss (MD 0.1 kg, 95% CI 3.0 to 2.8).
","[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Mulvaney', 'Affiliation': 'Lancaster Medical School, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Gonçalo S', 'Initials': 'GS', 'LastName': 'Duarte', 'Affiliation': 'Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Handley', 'Affiliation': 'Lancaster Medical School, Lancaster University, Lancaster, UK.'}, {'ForeName': 'David Jw', 'Initials': 'DJ', 'LastName': 'Evans', 'Affiliation': 'Lancaster Medical School, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Menon', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wyse', 'Affiliation': ""The Cure Parkinson's Trust, London, UK.""}, {'ForeName': 'Hedley Ca', 'Initials': 'HC', 'LastName': 'Emsley', 'Affiliation': 'Lancaster Medical School, Lancaster University, Lancaster, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012990.pub2']
1515,32701665,Effects of pharmacologic and nonpharmacologic interventions on menopause-related quality of life: a pooled analysis of individual participant data from four MsFLASH trials.,"OBJECTIVE


The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected menopause-related quality of life (QOL) measures. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions' effects on menopause-related QOL relative to control in women with VMS.
METHODS


We pooled individual-level data from 1,005 peri- and postmenopausal women with 14 or more VMS/week across the four RCTs. Interventions included escitalopram 10 to 20 mg/d; yoga/aerobic exercise; 1.8 g/d omega-3-fatty acids; oral 17-beta-estradiol 0.5 mg/d; venlafaxine XR 75 mg/d; and cognitive behavioral therapy for insomnia (CBT-I). Outcomes measures were the Menopause-specific Quality of Life scale and its subscales.
RESULTS


Significant improvements in total Menopause-specific Quality of Life from baseline were observed with estradiol, escitalopram, CBT-I, and yoga, with mean decreases of 0.3 to 0.5 points relative to control. The largest improvement in the vasomotor subscale was observed with estradiol (-1.2 points), with more modest but significant effects seen with escitalopram, yoga, and CBT-I. Significant improvements in the psychosocial subscale were observed for escitalopram, venlafaxine, and CBT-I. For the physical subscale, the greatest improvement was observed for CBT-I and exercise, whereas for the sexual subscale, the greatest improvement was observed for CBT-I, with yoga and estradiol demonstrating smaller effects.
CONCLUSIONS


These results suggest that for menopause-related QOL, women have a variety of treatment strategies to choose from and can select an approach based on most bothersome symptoms and individual preferences.",2020,"RESULTS


Significant improvements in total Menopause-specific Quality of Life from baseline were observed with estradiol, escitalopram, CBT-I, and yoga, with mean decreases of 0.3 to 0.5 points relative to control.","['1,005 peri- and postmenopausal women with 14 or more VMS/week across the four RCTs', 'women with VMS']","['escitalopram 10 to 20\u200amg/d; yoga/aerobic exercise; 1.8\u200ag/d omega-3-fatty acids; oral 17-beta-estradiol 0.5\u200amg/d; venlafaxine XR 75\u200amg/d; and cognitive behavioral therapy', 'venlafaxine', 'pharmacologic and nonpharmacologic interventions']","['vasomotor subscale', 'Menopause-specific Quality of Life scale and its subscales', 'menopause-related quality of life', 'insomnia symptoms', 'total Menopause-specific Quality of Life', 'psychosocial subscale']","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0397297,"RESULTS


Significant improvements in total Menopause-specific Quality of Life from baseline were observed with estradiol, escitalopram, CBT-I, and yoga, with mean decreases of 0.3 to 0.5 points relative to control.","[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Diem', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Andrea Z', 'Initials': 'AZ', 'LastName': 'LaCroix', 'Affiliation': 'Department of Family Medicine and Public Health, University of California - San Diego, La Jolla, CA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington, Seattle, WA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Larson', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Newton', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA.'}, {'ForeName': 'Kristine E', 'Initials': 'KE', 'LastName': 'Ensrud', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Woods', 'Affiliation': 'School of Nursing, University of Washington, Seattle, WA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001597']
1516,32715442,"Variation in the UGT2B17 genotype, exemestane metabolism and menopause-related toxicities in the CCTG MAP.3 trial.","PURPOSE


To examine associations between the UGT2B17 gene deletion and exemestane metabolites, and commonly reported side effects (fatigue, hot flashes, and joint pain) among postmenopausal women participating in the MAP.3 chemoprevention trial.
METHODS


The analytical samples for the UGT2B17 analysis comprised 1752 women on exemestane and 1721 women on placebo; the exemestane metabolite analysis included 1360 women on exemestane with one-year serum samples. Both the UGT2B17 gene deletion and metabolites were measured in blood. The metabolites were conceptualized as a ratio (17-DHE-Gluc:17-DHE). Symptoms were assessed using the CTCAE v4.0 at approximately 1-year intervals. Log-binomial regression was used to examine the associations between UGT2B17 deletion, exemestane metabolites and each side effect at 1 and up to 5-year follow-up, adjusting for potential confounders.
RESULTS


Among individuals on exemestane with the UGT2B17 gene deletion (i.e., lower detoxification), a higher risk of severe fatigue (RR = 2.59 95% CI: 1.14-5.89) was observed at up to 5-year follow-up. Among individuals on placebo, those with the UGT2B17 gene deletion had a higher risk of any fatigue (RR = 1.39, 95% CI: 1.02-1.89) at year 1. A lower metabolite ratio (poor detoxification) was associated with a higher risk of any fatigue, hot flashes and joint pain at year 1 (fatigue: RR = 1.89, 95% CI: 1.16-3.09; hot flashes: RR = 1.77, 95% CI: 1.40-2.24; joint pain: RR = 2.05, 95% CI: 1.35-3.12); similar associations were observed at 5-year follow-up.
CONCLUSION


Variation in the metabolism of exemestane through the UGT2B17-mediated pathway is associated with subsequent risk of commonly reported symptoms in MAP.3.",2020,"A lower metabolite ratio (poor detoxification) was associated with a higher risk of any fatigue, hot flashes and joint pain at year 1 (fatigue: RR = 1.89, 95% CI: 1.16-3.09; hot flashes: RR = 1.77, 95% CI: 1.40-2.24; joint pain: RR = 2.05, 95% CI: 1.35-3.12); similar associations were observed at 5-year follow-up.
","['analysis included 1360 women on exemestane with one-year serum samples', '1752 women on exemestane and 1721 women on', 'postmenopausal women participating in the MAP.3 chemoprevention trial']","['exemestane', 'exemestane metabolite', 'placebo']","['higher risk of any fatigue, hot flashes and joint pain', 'severe fatigue', 'higher risk of any fatigue', 'side effects (fatigue, hot flashes, and joint pain', 'metabolite ratio (poor detoxification']","[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}]",1752.0,0.292134,"A lower metabolite ratio (poor detoxification) was associated with a higher risk of any fatigue, hot flashes and joint pain at year 1 (fatigue: RR = 1.89, 95% CI: 1.16-3.09; hot flashes: RR = 1.77, 95% CI: 1.40-2.24; joint pain: RR = 2.05, 95% CI: 1.35-3.12); similar associations were observed at 5-year follow-up.
","[{'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Ho', 'Affiliation': 'Department of Social and Preventive Medicine, University of Montreal, 850 rue Saint-Denis, Tour Saint-Antoine, 3rd Floor, S03.412, Montréal, QC, H2X0A9, Canada.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Pasquet', 'Affiliation': 'Department of Social and Preventive Medicine, University of Montreal, 850 rue Saint-Denis, Tour Saint-Antoine, 3rd Floor, S03.412, Montréal, QC, H2X0A9, Canada.'}, {'ForeName': 'Shaman', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, 412 E. Spokane Falls Blvd., PBS 431, Spokane, WA, 99202-2131, USA.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, 412 E. Spokane Falls Blvd., PBS 431, Spokane, WA, 99202-2131, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Goss', 'Affiliation': 'Harvard Medical School, MGH Cancer Center, Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': ""Division Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, ON, K7L 3N6, Canada.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lazarus', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, 412 E. Spokane Falls Blvd., PBS 431, Spokane, WA, 99202-2131, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Richardson', 'Affiliation': ""Divisions of Canadian Cancer Trials Group and Cancer Care and Epidemiology, Cancer Research Institute, Queen's University, 10 Stuart Street, Room 220, Kingston, ON, K7L 3N6, Canada. hrichardson@ctg.queensu.ca.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Breast cancer research and treatment,['10.1007/s10549-020-05812-1']
1517,32717448,"Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study.","STUDY OBJECTIVE


Adequate perioperative pain control in children undergoing cardiac surgery is mandatory. Intravenous opioids and neuraxial anesthetic techniques have been used but didn't gained any popularity. The aim of the current study was to evaluate the analgesic efficacy of transversus thoracis plane (TTP) block in pediatric cardiac surgery.
DESIGN


Superiority, randomized, double-blind, controlled study.
SETTING


Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt.
PATIENTS


Eighty pediatric patients aged 2-12 years, undergoing cardiac surgery via median sternotomy, were randomly allocated into 2 equal groups, the control group and TTP block group.
INTERVENTIONS


Controlled group received only fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group).
MEASUREMENTS


The primary outcome measure was the total dose of fentanyl in the first postoperative 24 h after extubation, while the secondary outcome measures were postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay.
MAIN RESULTS


During the first postoperative 24 h, total fentanyl consumption was significantly lower (P < 0.05) in the TTP block group (9.892 ± 3.397 μg/kg) than the control group (18.500 ± 3.401 μg/kg) and modified objective pain score was significantly (P < 0.05) lower in TTP block group than the control group all over the time. Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
CONCLUSION


The use of TTP block decreased perioperative fentanyl consumption and reduced postoperative pain intensity.",2020,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","['children undergoing cardiac surgery', 'Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt', 'Eighty pediatric patients aged 2-12\xa0years, undergoing cardiac surgery via median sternotomy', 'pediatric cardiac surgery']","['TTP block', 'transversus thoracis plane (TTP) block', 'fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group', 'control group and TTP block group', 'ultrasound guided bilateral transversus thoracis muscle plane block']","['postoperative pain intensity', 'modified objective pain score', 'perioperative fentanyl consumption', 'Analgesic efficacy', 'analgesic efficacy', 'total fentanyl consumption', 'Total intraoperative fentanyl requirement', 'postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay', 'total dose of fentanyl in the first postoperative 24\xa0h after extubation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}]","[{'cui': 'C1744608', 'cui_str': 'Structure of transverse thoracis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",80.0,0.408484,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","[{'ForeName': 'Ibrahim I', 'Initials': 'II', 'LastName': 'Abdelbaser', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt. Electronic address: ibraheem2005@mans.edu.eg.'}, {'ForeName': 'Nabil A', 'Initials': 'NA', 'LastName': 'Mageed', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110002']
1518,32723670,"A Phase III, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of Once-daily SPN-812 (Viloxazine Extended-release) in the Treatment of Attention-deficit/Hyperactivity Disorder in School-age Children.","PURPOSE


The limitations of current US Food and Drug Administration (FDA)-approved medications for the treatment of attention-deficit/hyperactivity disorder (ADHD) set the need for the development of novel, effective, and tolerable medications to treat this disorder. The purpose of this study was to evaluate whether treatment with SPN-812 (viloxazine extended-release) significantly reduces symptoms of ADHD in children.
METHODS


This study was a randomized, double-blind, placebo-controlled 6-week trial to assess the efficacy and safety of once-daily 100- and 200-mg SPN-812 in the treatment of ADHD in male and female children 6-11 years of age. Inclusion criteria required subjects to have a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, ADHD diagnosis, an ADHD-Rating Scale-5 (ADHD-RS-5) score ≥28, a Clinical Global Impression-Severity score ≥4, and for subjects to be free of ADHD medication ≥1 week before randomization. The primary efficacy endpoint was the change from baseline (CFB) at end of study (EOS) in ADHD-RS-5 Total score. Key secondary endpoints included Clinical Global Impression-Improvement (CGI-I) scores at EOS and CFB at EOS in the Conners 3-Parent Short Form (Conners 3-PS) Composite T-score and the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P) Total average score. Safety assessments included adverse events (AEs), laboratory tests, vital signs, physical examinations, ECGs, and the Columbia-Suicide Severity Rating Scale. The primary efficacy endpoint was analyzed by using a mixed model for repeated measures; all secondary measures were analyzed by using an ANCOVA model.
RESULTS


A total of 477 subjects were randomized to treatment (intent-to-treat population, n = 460). The majority of subjects were male (63%) and either White (51.3%) or African American (43.7%). The demographic and baseline characteristics between the groups were similar. Statistically significant improvements in ADHD-RS-5 Total score were observed in both the 100- and 200-mg/day SPN-812 treatment groups compared to placebo at week 1 of treatment (P = 0.0004 and P = 0.0244, respectively), which was maintained through EOS (P = 0.0004 and P < 0.0001). Significant improvements were also observed at EOS in the CGI-I scale (P = 0.0020 and P < 0.0001), Conners 3-PS Composite T-score (P = 0.0003 and P = 0.0002), and WFIRS-P Total average score (P = 0.0019 and P = 0.0002) versus placebo. Treatment-related AEs reported in ≥5% of subjects included somnolence, decreased appetite, and headache. The discontinuation rate due to AEs was <5%.
IMPLICATIONS


SPN-812 significantly reduced ADHD symptoms in children and was well tolerated. SPN-812 may prove to be an effective treatment for children with ADHD. ClinicalTrials.gov identifier: NCT03247530.",2020,"Significant improvements were also observed at EOS in the CGI-I scale (P = 0.0020 and P < 0.0001), Conners 3-PS Composite T-score (P = 0.0003 and P = 0.0002), and WFIRS-P Total average score (P = 0.0019 and P = 0.0002) versus placebo.","['male and female children 6-11 years of age', 'children', 'children with ADHD', 'Attention-Deficit/Hyperactivity Disorder in School-age Children', '477 subjects', 'subjects were male (63%) and either White (51.3%) or African American (43.7']","['once-daily 100- and 200-mg SPN-812', 'Placebo', 'SPN-812 (viloxazine extended-release', 'current US Food and Drug Administration (FDA)-approved medications', 'SPN-812', 'Once-Daily SPN-812 (Viloxazine Extended-Release', 'placebo']","['Efficacy and Safety', 'Composite T-score and the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P) Total average score', 'discontinuation rate', 'tolerated', 'adverse events (AEs), laboratory tests, vital signs, physical examinations, ECGs, and the Columbia-Suicide Severity Rating Scale', 'ADHD-RS-5 Total score', 'WFIRS-P Total average score', 'somnolence, decreased appetite, and headache', 'efficacy and safety', 'Conners 3-PS Composite T-score', 'ADHD symptoms', 'CGI-I scale', 'Clinical Global Impression-Improvement (CGI-I) scores at EOS and CFB at EOS in the Conners 3-Parent Short Form (Conners 3-PS', 'change from baseline (CFB) at end of study (EOS) in ADHD-RS-5 Total score']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2350019', 'cui_str': 'Solitary nodule of lung'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042665', 'cui_str': 'Viloxazine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0009002', 'cui_str': 'Clofibrate'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",477.0,0.172322,"Significant improvements were also observed at EOS in the CGI-I scale (P = 0.0020 and P < 0.0001), Conners 3-PS Composite T-score (P = 0.0003 and P = 0.0002), and WFIRS-P Total average score (P = 0.0019 and P = 0.0002) versus placebo.","[{'ForeName': 'Azmi', 'Initials': 'A', 'LastName': 'Nasser', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, MD, USA. Electronic address: anasser@supernus.com.'}, {'ForeName': 'Tesfaye', 'Initials': 'T', 'LastName': 'Liranso', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, MD, USA.'}, {'ForeName': 'Toyin', 'Initials': 'T', 'LastName': 'Adewole', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, MD, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Fry', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, MD, USA.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Hull', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, MD, USA.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Chowdhry', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, MD, USA.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Busse', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, MD, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cutler', 'Affiliation': 'SUNY Upstate Medical University, and Neuroscience Education Institute, Lakewood Ranch, FL, USA.'}, {'ForeName': 'Nandita Joshi', 'Initials': 'NJ', 'LastName': 'Jones', 'Affiliation': 'CNS Healthcare, Jacksonville, FL, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond, VA, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schwabe', 'Affiliation': 'Supernus Pharmaceuticals, Inc, Rockville, MD, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.021']
1519,32728734,Using an Adjunctive Treatment to Address Psychological Distress in a National Weight Management Program: Results of an Integrated Pilot Study.,"INTRODUCTION


Obesity is highly comorbid with psychological symptoms in veterans, particularly post-traumatic stress disorder (PTSD), depression, and anxiety. Obese veterans with comorbid psychological symptoms often display suboptimal weight loss and poor physical functioning when participating in weight management programs. The MOVE! program aims to increase healthy eating and physical activity to promote weight loss in obese veterans. Adequately addressing psychological barriers is necessary to maximize outcomes in MOVE! for veterans with PTSD, depression, and anxiety. We examined the preliminary outcomes of administering the Healthy Emotions and Improving Health BehavioR Outcomes (HERO) intervention. HERO is adjunctive cognitive-behavioral therapy to MOVE! that addresses PTSD, depression, and anxiety symptom barriers to engagement in physical activity.
MATERIALS AND METHODS


All recruitment and study procedures were approved by the institutional review board and research and development committees of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, Texas. Participants gave written informed consent before enrollment. Thirty-four obese veterans with a diagnosis of PTSD, depression, and/or anxiety who were attending MOVE! were assigned to the 8-session HERO group or the usual care (UC) group. Veterans completed assessments of PTSD, depression and anxiety symptoms, physical activity, physical functioning, and weight at baseline, 8 and 16 weeks post treatment. Changes from baseline to 8- and 16-week follow-up on the self-report and clinician-rated measures were assessed, using independent samples t-tests and analyses of covariance.
RESULTS


At 8 weeks post treatment, participants in the HERO group had significantly higher step counts per day than participants in the UC group. Similarly, at 16 weeks post-treatment, participants in the HERO group continued to experience a significant increase in daily steps taken per day, as well as statistically and clinically significantly lower scores on the depression symptom and PTSD symptom severity. Participants in the HERO group also demonstrated significantly higher scores on the physical functioning inventory than participants in the UC group (44.1 ± 12.1 vs. 35.7 ± 10.7, P = 0.04) at 16 weeks post treatment.
CONCLUSIONS


Findings of this small trial have important implications pending replication in a more rigorously designed large-scale study. Providing an adjunctive treatment to MOVE! that addresses psychological distress has potential benefits for psychological symptom reduction, engagement in healthy dietary habits, and greater physical activity for individuals who traditionally experience barriers to making positive weight management changes.",2020,"At 8 weeks post treatment, participants in the HERO group had significantly higher step counts per day than participants in the UC group.","['Thirty-four obese veterans with a diagnosis of PTSD, depression, and/or anxiety who were attending MOVE', 'Psychological Distress in a National Weight Management Program', 'All recruitment and study procedures were approved by the institutional review board and research and development committees of the Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine in Houston, Texas', 'Obese veterans with comorbid psychological symptoms often display suboptimal weight loss and poor physical functioning when participating in weight management programs', 'obese veterans', 'veterans with PTSD, depression, and anxiety']","['HERO', '8-session HERO group or the usual care (UC']","['Health BehavioR', 'PTSD, depression and anxiety symptoms, physical activity, physical functioning, and weight', 'physical functioning inventory', 'healthy eating and physical activity', 'daily steps', 'depression symptom and PTSD symptom severity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0035170', 'cui_str': 'Research and Development'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",,0.0176149,"At 8 weeks post treatment, participants in the HERO group had significantly higher step counts per day than participants in the UC group.","[{'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Evans-Hudnall', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, (MEDVAMC 152), 2002 Holcombe Blvd., Houston, TX 77030.'}, {'ForeName': 'Mary O', 'Initials': 'MO', 'LastName': 'Odafe', 'Affiliation': 'Department of Clinical Psychology, University of Houston, Heyne building # 126, Houston, TX 77204.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'William S. Middleton Veterans Affairs Hospital, 2500 Overlook Terrace, Madison, WI 53705.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Armenti', 'Affiliation': 'Department of Clinical Psychology, University of Houston, Heyne building # 126, Houston, TX 77204.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': ""O'Neil"", 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, One Baylor Plaza, Baylor College of Medicine, Houston, TX 77030.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Lawson', 'Affiliation': 'Department of Counseling Psychology, University of North Texas, 1155 Union Circle #311280, Denton, Texas 76203-5017.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Trahan', 'Affiliation': 'Trahan Counseling, 631 Mill Street, Suite 101 San Marcos, Texas 78666.'}, {'ForeName': 'Fenan S', 'Initials': 'FS', 'LastName': 'Rassu', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, One Baylor Plaza, Baylor College of Medicine, Houston, TX 77030.'}]",Military medicine,['10.1093/milmed/usaa145']
1520,32728763,Anthropometric Aspects in the Breast Augmentation.,"BACKGROUND


Studies have demonstrated the importance of anthropometric measurements of the breasts, based on linear measurements for the selection of the volume of breast implants, their positioning, and surgical planning.
OBJECTIVES


The objective of this study is to evaluate the main changes in anthropometric measurements in breast augmentation.
METHODS


A prospective, randomized clinical study with 74 female candidates for breast augmentation. All the individuals were split into five groups, according to the implant volume. The implants used were of different textures, from three different brands (LifeSil, Politech, and Silimed). The following measures were taken: distance from the nipple to the inframammary fold (N-IMF), inter-nipple-areolar complex distance (N-N), distance from the Sternal notch to the Nipple (SN-N), areola diameter, and breast projection.
RESULTS


The most significant breast anthropometric alteration after mammoplasty was the N-IMF distance; that is, an expansion of the lower pole of the breast, followed by an increase in the areolar diameter. Mostly of measurements showed stability between 3rd and 6th months after the surgery. The projection was the most interesting measure due to presenting two patterns of behavior according to the analysis criteria performed. When comparing the implant projection and the final breast projection, it was observed that the implant profile represented a 27% increase in the final breast projection.
CONCLUSIONS


This study provides an essential comparative analysis between anthropometric changes in breast augmentations and serves as a predictive tool in the preoperative evaluation of the patient during surgical planning.
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,"When comparing the implant projection and the final breast projection, it was observed that the implant profile represented a 27% increase in the final breast projection.
",['74 female candidates for breast augmentation'],['IV'],"['nipple to the inframammary fold (N-IMF), inter-nipple-areolar complex distance (N-N), distance from the Sternal notch to the Nipple (SN-N), areola diameter, and breast projection']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}]",[],"[{'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0442099', 'cui_str': 'Inframammary'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205316', 'cui_str': 'Notched'}, {'cui': 'C0222608', 'cui_str': 'Areola structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",74.0,0.034736,"When comparing the implant projection and the final breast projection, it was observed that the implant profile represented a 27% increase in the final breast projection.
","[{'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Charles-de-Sá', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil. clinicaperforma@uol.com.br.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'de Aguiar Valladão', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil.'}, {'ForeName': 'Diogo Maciel Lobão', 'Initials': 'DML', 'LastName': 'Vieira', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil.'}, {'ForeName': 'José Horácio', 'Initials': 'JH', 'LastName': 'Aboudib', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research, State University of Rio de Janeiro- UERJ-RJ, Av. Joana Angélica, 124/602, Ipanema, Rio de Janeiro-Rj-Cep, 22420-030, Brazil.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01853-5']
1521,32730561,Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis.,"Importance


Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery.
Objective


To determine the success rate of nonoperative management and compare differences in treatment-related disability, satisfaction, health-related quality of life, and complications between nonoperative management and surgery in children with uncomplicated appendicitis.
Design, Setting, and Participants


Multi-institutional nonrandomized controlled intervention study of 1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019. Of the 1209 eligible patients approached, 1068 enrolled in the study.
Interventions


Patient and family selection of nonoperative management with antibiotics alone (nonoperative group, n = 370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n = 698).
Main Outcomes and Measures


The 2 primary outcomes assessed at 1 year were disability days, defined as the total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care (expected difference, 5 days), and success rate of nonoperative management, defined as the proportion of patients initially managed nonoperatively who did not undergo appendectomy by 1 year (lowest acceptable success rate, ≥70%). Inverse probability of treatment weighting (IPTW) was used to adjust for differences between treatment groups for all outcome assessments.
Results


Among 1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery. A total of 806 (75%) had complete follow-up: 284 (77%) in the nonoperative group; 522 (75%) in the surgery group. Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%). After IPTW, the success rate of nonoperative management at 1 year was 67.1% (96% CI, 61.5%-72.31%; P = .86). Nonoperative management was associated with significantly fewer patient disability days at 1 year than did surgery (adjusted mean, 6.6 vs 10.9 days; mean difference, -4.3 days (99% CI, -6.17 to -2.43; P < .001). Of 16 other prespecified secondary end points, 10 showed no significant difference.
Conclusion and Relevance


Among children with uncomplicated appendicitis, an initial nonoperative management strategy with antibiotics alone had a success rate of 67.1% and, compared with urgent surgery, was associated with statistically significantly fewer disability days at 1 year. However, there was substantial loss to follow-up, the comparison with the prespecified threshold for an acceptable success rate of nonoperative management was not statistically significant, and the hypothesized difference in disability days was not met.
Trial Registration


ClinicalTrials.gov Identifier: NCT02271932.",2020,"Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%).","['1209 eligible patients approached, 1068 enrolled in the study', ""1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019"", 'Children With Uncomplicated Appendicitis', 'children with uncomplicated appendicitis', '1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery']","['Antibiotic Therapy vs Laparoscopic Appendectomy', 'antibiotics alone', 'antibiotics alone (nonoperative group, n\u2009=\u2009370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n\u2009=\u2009698']","['total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care', 'disability, satisfaction, health-related quality of life, and complications', 'patient disability days', 'Inverse probability of treatment weighting (IPTW', 'success rate', 'success rate of nonoperative management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",1068.0,0.123447,"Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%).","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Minneci', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Erinn M', 'Initials': 'EM', 'LastName': 'Hade', 'Affiliation': 'Departments of Biomedical Informatics and Obstetrics & Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Lawrence', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Yuri V', 'Initials': 'YV', 'LastName': 'Sebastião', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Saito', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Grace Z', 'Initials': 'GZ', 'LastName': 'Mak', 'Affiliation': 'Section of Pediatric Surgery, Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Illinois.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Section of Pediatric Surgery, Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Illinois.'}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Hirschl', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Michigan School of Medicine, Ann Arbor.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gadepalli', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Michigan School of Medicine, Ann Arbor.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Helmrath', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Kohler', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Leys', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Thomas T', 'Initials': 'TT', 'LastName': 'Sato', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Dave R', 'Initials': 'DR', 'LastName': 'Lal', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Landman', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Kabre', 'Affiliation': ""Division of Pediatric Surgery, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois.""}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Fallat', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Louisville School of Medicine, Louisville, Kentucky.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Cooper', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Deans', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.10888']
1522,32694184,Restarting CPAP Therapy for Sleep Apnea After a Previous Failure.,"BACKGROUND


About one third of patients fail their first CPAP trial due to several factors. Despite its clinical importance, data on the success of CPAP re-initiation are scarce.
METHODS


Of the 6,231 patients referred to our sleep unit for sleep apnea, we included 224 subjects referred for re-initiation of CPAP therapy (re-CPAP). The control group consisted of 228 CPAP-naïve subjects referred for CPAP initiation. Data on subject characteristics, sleep study, and CPAP outcome were collected.
RESULTS


The re-CPAP group had more severe apnea than the control group. After at least 1 y of CPAP therapy, 52% of the re-CPAP group stayed on therapy; this was significantly lower than the 67% adherence for the control group ( P  = .001). No gender difference was observed in the control group ( P  = .12), whereas women in the re-CPAP group remained on therapy significantly less than men ( P  = .002).
CONCLUSIONS


The percentage of subjects who stayed on CPAP therapy after 1 y was significantly reduced when CPAP was re-initiated compared to the control group. CPAP acceptance after re-initiation was higher among men than women. Further studies are necessary to explain this gender difference.",2020,"No gender difference was observed in the control group ( P  = .12), whereas women in the re-CPAP group remained on therapy significantly less than men ( P  = .002).
","['224 subjects referred for re-initiation of CPAP therapy (re-CPAP', '6,231 patients referred to our sleep unit for sleep apnea', 'men than women']","['228 CPAP-naïve subjects referred for CPAP initiation', 'Restarting CPAP Therapy']","['CPAP acceptance', 'severe apnea', 'Sleep Apnea']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}]",224.0,0.0300057,"No gender difference was observed in the control group ( P  = .12), whereas women in the re-CPAP group remained on therapy significantly less than men ( P  = .002).
","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Avellan-Hietanen', 'Affiliation': 'Sleep Unit, Heart and Lung Centre, Helsinki University Hospital, University of Helsinki, Helsinki, Finland. heidi.avellan-hietanen@hus.fi.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Maasilta', 'Affiliation': 'Sleep Unit, Heart and Lung Centre, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Bachour', 'Affiliation': 'Sleep Unit, Heart and Lung Centre, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}]",Respiratory care,['10.4187/respcare.07766']
1523,32694214,"Clinical Parameters, Fuel Oxidation, and Glucose Kinetics in Patients With Type 2 Diabetes Treated With Dapagliflozin Plus Saxagliptin.","OBJECTIVE


To examine the mechanisms responsible for improved glycemia with combined sodium-glucose cotransporter 2 inhibitor (SGLT2i) plus dipeptidyl peptidase 4 inhibitor therapy in type 2 diabetes.
RESEARCH DESIGN AND METHODS


Fifty-six patients (HbA 1c  8.9 ± 0.2% [74 ± 2 mmol/mol]) were randomized to dapagliflozin (DAPA) 10 mg, DAPA/saxagliptin (SAXA) 10/5 mg, or placebo (PCB) for 16 weeks. Basal endogenous glucose production (EGP) (3- 3 H-glucose), urinary glucose excretion, glucose/lipid oxidation, HbA 1c , and substrate/hormone levels were determined before treatment (Pre-Tx) and after treatment (Post-Tx).
RESULTS


At week 16, HbA 1c  decrease was greater ( P  < 0.05) in DAPA/SAXA (-2.0 ± 0.3%) vs. DAPA (-1.4 ± 0.2%) and greater than PCB (0.2 ± 0.2%). Day 1 of drug administration, EGP (∼2.40 mg/kg/min) decreased by -0.44 ± 0.09 mg/kg/min in PCB ( P  < 0.05) but only by -0.21 ± 0.02 mg/kg/min in DAPA and DAPA/SAXA ( P  < 0.05 vs. PCB). At week 16, EGP increased to 2.67 ± 0.09 mg/kg/min (DAPA) and 2.61 ± 0.08 mg/kg/min (DAPA/SAXA), despite reductions in fasting plasma glucose by 47 and 77 mg/dL, respectively, and no changes in PCB. Baseline plasma free fatty acids rose by 40 µmol/L with DAPA but declined by -110 with PCB and -90 µmol/L with DAPA/SAXA ( P  < 0.05, Pre-Tx vs. Post-Tx). In DAPA, carbohydrate oxidation rates decreased from 1.1 ± 0.1 to 0.7 ± 0.1 mg/kg/min, whereas lipid oxidation rates increased from 0.6 ± 0.1 to 0.8 ± 0.1 mg/kg/min ( P  < 0.01). In DAPA/SAXA, the shift in carbohydrate (1.1 ± 0.1 to 0.9 ± 0.1 mg/kg/min) and lipid (0.6 ± 0.1 to 0.7 ± 0.1 mg/kg/min) oxidation was attenuated ( P  < 0.05).
CONCLUSIONS


The addition of SAXA to DAPA resulted in superior glycemic control compared with DAPA monotherapy partly because of increased glucose utilization and oxidation. Although the decrease in insulin/glucagon ratio was prevented by SAXA, EGP paradoxical elevation persisted, indicating that other factors mediate EGP changes in response to SGLT2i-induced glucosuria.",2020,"At week 16, HbA 1c  decrease was greater ( P  < 0.05) in DAPA/SAXA (-2.0 ± 0.3%) vs. DAPA (-1.4 ± 0.2%) and greater than PCB (0.2 ± 0.2%).","['Fifty-six patients (HbA 1c  8.9 ± 0.2% [74 ± 2 mmol/mol', 'Patients With Type 2 Diabetes Treated With']","['Dapagliflozin Plus Saxagliptin', 'combined sodium-glucose cotransporter 2 inhibitor (SGLT2i) plus dipeptidyl peptidase 4 inhibitor therapy', 'dapagliflozin (DAPA) 10 mg, DAPA/saxagliptin (SAXA) 10/5 mg, or placebo (PCB', 'EGP']","['glucose utilization and oxidation', 'insulin/glucagon ratio', 'carbohydrate oxidation rates', 'Clinical Parameters, Fuel Oxidation, and Glucose Kinetics', 'Basal endogenous glucose production (EGP) (3- 3 H-glucose), urinary glucose excretion, glucose/lipid oxidation, HbA 1c , and substrate/hormone levels', 'lipid oxidation rates', 'Baseline plasma free fatty acids', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032447', 'cui_str': 'Polychlorinated biphenyl'}, {'cui': 'C0903677', 'cui_str': 'TACSTD1 protein, human'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",,0.0320243,"At week 16, HbA 1c  decrease was greater ( P  < 0.05) in DAPA/SAXA (-2.0 ± 0.3%) vs. DAPA (-1.4 ± 0.2%) and greater than PCB (0.2 ± 0.2%).","[{'ForeName': 'Yuejuan', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Texas Diabetes Institute-University Health System and UT Health San Antonio, San Antonio, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Texas Diabetes Institute-University Health System and UT Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Solis-Herrera', 'Affiliation': 'Texas Diabetes Institute-University Health System and UT Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Texas Diabetes Institute-University Health System and UT Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'Texas Diabetes Institute-University Health System and UT Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'Texas Diabetes Institute-University Health System and UT Health San Antonio, San Antonio, TX cersosimo@uthscsa.edu.'}]",Diabetes care,['10.2337/dc19-1993']
1524,32694215,"Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial.","OBJECTIVE


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


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


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


A once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP-1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify basal plus prandial insulin treatments and achieve better outcomes in type 2 diabetes.",2020,"Gastrointestinal adverse events were higher with albiglutide + glargine (26% vs. 13%).
","['type 2 diabetes', 'Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy']","['lispro + glargine', 'lispro plus optimized glargine', 'albiglutide + glargine', 'albiglutide plus optimized basal insulin glargine and lispro', 'prandial insulin lispro with a once-weekly glucagon-like peptide 1 receptor agonist (GLP-1RA', 'Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide']","['number of prandial insulin injections; glycemic control', 'Total daily prandial insulin dose', 'weight loss and less hypoglycemia', 'total number of weekly injections', 'symptomatic hypoglycemia', 'Gastrointestinal adverse events', 'Mean ± SD HbA 1c']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2607479', 'cui_str': 'albiglutide'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",,0.146788,"Gastrointestinal adverse events were higher with albiglutide + glargine (26% vs. 13%).
","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, TX juliorosenstock@dallasdiabetes.com.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nino', 'Affiliation': 'Research and Development Immuno-Inflammation Therapy Area Unit, GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Soffer', 'Affiliation': 'Research and Development Future Pipelines Discovery, GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Erskine', 'Affiliation': 'Clinical Development, GlaxoSmithKline, King of Prussia, PA.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Acusta', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Dole', 'Affiliation': 'Research and Development Future Pipelines Discovery, GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Molly C', 'Initials': 'MC', 'LastName': 'Carr', 'Affiliation': 'Research and Development Future Pipelines Discovery, GlaxoSmithKline, Collegeville, PA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mallory', 'Affiliation': 'Clinical Development, GlaxoSmithKline, King of Prussia, PA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Home', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, U.K.'}]",Diabetes care,['10.2337/dc19-2316']
1525,32698326,Psychometric and Structural Validity of the Pittsburgh Sleep Quality Index among Filipino Domestic Workers.,"Objectives : Evaluate the psychometric properties and structural validity of the Filipino version of the Pittsburgh Sleep Quality Index (PSQI) among Filipino domestic workers (FDWs).  Methods : In Study 1, 131 FDWs completed PSQI and other scales, along with 10-day actigraphic assessment with accompanying electronic daily sleep dairy. A subsample of 61 participants completed follow-up assessment after 10 days. In Study 2, 1363 FDWs were recruited and randomized into two halves. Exploratory factor analysis (EFA) and Confirmatory factor analysis (CFA) were used in the two halves, respectively.  Results : In Study 1, the Cronbach's alpha of the PSQI was 0.63 at baseline and 0.67 at follow-up. Test-retest reliability for the PSQI global score based on intraclass correlation was 0.63. Convergent validity was supported by the significant associations between the PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination. Small correlations between the PSQI global score and measures of daytime sleepiness, social support, and self-reported height, supported discriminant validity. In Study 2, EFA yielded two PSQI factors with acceptable factor loadings. CFA established that this two-factor model, comprised of perceived sleep quality and sleep efficiency, evidenced better model fit than alternative models tested. The Cronbach's alpha of two factors was 0.70 and 0.81, respectively.  Conclusions : The PSQI demonstrated good internal consistency of two factors, and good convergent, and divergent validity. Results can be referenced in future studies to measure and screen sleep dysfunction among clinical and non-clinical populations in the Philippines.",2020,"Convergent validity was supported by the significant associations between the PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination.","['1363 FDWs', 'Filipino domestic workers (FDWs', 'Filipino Domestic Workers']",['Filipino version of the Pittsburgh Sleep Quality Index (PSQI'],"['Exploratory factor analysis (EFA) and Confirmatory factor analysis (CFA', 'sleep quality and sleep efficiency', 'PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination', 'PSQI global score and measures of daytime sleepiness, social support, and self-reported height', 'Psychometric and Structural Validity of the Pittsburgh Sleep Quality Index']","[{'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]","[{'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",1363.0,0.0399617,"Convergent validity was supported by the significant associations between the PSQI global score, PSQI components scores, sleep patterns from the daily sleep diary, and measures of depression, anxiety, and rumination.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xiong', 'Affiliation': 'Division of Medical Psychology and Behavioral Sciences, Department of Public Health and Preventive Medicine, School of Medicine, Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Spira', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Johns Hopkins Center on Aging and Health, Baltimore, MD 21205, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Hall', 'Affiliation': 'Global and Community Mental Health Research Group, Department of Psychology, The University of Macau, Macau (SAR) 999078, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17145219']
1526,32700098,"Suspension training vs. traditional resistance training: effects on muscle mass, strength and functional performance in older adults.","PURPOSE


We compared the effects of suspension training (ST) with traditional resistance training (TRT) on muscle mass, strength and functional performance in older adults.
METHODS


Forty-two untrained older adults were randomized in TRT, ST (both performed 3 sets of whole body exercises to muscle failure) or control group (CON). Muscle thickness (MT) of biceps brachii (MT BB ) and vastus lateralis (MT VL ), maximal dynamic strength test (1RM) for biceps curl (1RM BC ) and leg extension exercises (1RM LE ), and functional performance tests (chair stand [CS], timed up and go [TUG] and maximal gait speed [MGS]) were performed before and after 12 weeks of training.
RESULTS


MT BB  increased significantly and similarly for all training groups (TRT 23.35%; ST 21.56%). MT VL  increased significantly and similarly for all training groups (TRT 13.03%; ST 14.07%). 1RM BC  increased significantly and similarly for all training groups (TRT 16.06%; ST 14.33%). 1RM LE  increased significantly and similarly for all training groups (TRT 14.89%; ST 18.06%). MGS increased significantly and similarly for all groups (TRT 6.26%; ST 5.99%; CON 2.87%). CS decreased significantly and similarly for all training groups (TRT - 20.80%; ST - 15.73%). TUG decreased significantly and similarly for all training groups (TRT - 8.66%; ST - 9.16%).
CONCLUSION


Suspension training (ST) promotes similar muscle mass, strength and functional performance improvements compared to TRT in older adults.",2020,1RM BC  increased significantly and similarly for all training groups (TRT 16.06%; ST 14.33%).,"['Forty-two untrained older adults', 'older adults']","['Suspension training vs. traditional resistance training', 'suspension training (ST) with traditional resistance training (TRT', 'TRT, ST (both performed 3 sets of whole body exercises to muscle failure) or control group (CON', 'Suspension training (ST']","['MGS', 'TUG', '1RM BC', 'CS', 'MT BB', 'Muscle thickness (MT) of biceps brachii (MT BB ) and vastus lateralis (MT VL ), maximal dynamic strength test (1RM) for biceps curl (1RM BC ) and leg extension exercises (1RM LE ), and functional performance tests (chair stand [CS], timed up and go [TUG] and maximal gait speed [MGS', '1RM LE', 'muscle mass, strength and functional performance', 'MT VL']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010474', 'cui_str': ""Curling's ulcers""}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]",42.0,0.0105798,1RM BC  increased significantly and similarly for all training groups (TRT 16.06%; ST 14.33%).,"[{'ForeName': 'Samuel Domingos', 'Initials': 'SD', 'LastName': 'Soligon', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Deivid Gomes', 'Initials': 'DG', 'LastName': 'da Silva', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'João Guilherme Almeida', 'Initials': 'JGA', 'LastName': 'Bergamasco', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Angleri', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Ricardo Alessandro Medalha', 'Initials': 'RAM', 'LastName': 'Júnior', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Nathalia Fernanda', 'Initials': 'NF', 'LastName': 'Dias', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Sanmy Rocha', 'Initials': 'SR', 'LastName': 'Nóbrega', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'de Castro Cesar', 'Affiliation': 'Department of Medicine, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil.'}, {'ForeName': 'Cleiton Augusto', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'MUSCULAB, Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, UFSCar, Rod. Washington Luiz, km 235-SP 310, São Carlos, SP, 13565-905, Brazil. c.libardi@ufscar.br.'}]",European journal of applied physiology,['10.1007/s00421-020-04446-x']
1527,32703613,Effects of a Single Myofascial Induction Session on Neural Mechanosensitivity in Breast Cancer Survivors: A Secondary Analysis of a Crossover Study.,"OBJECTIVES


The purpose of this study was to investigate the short-term effects of myofascial induction on mechanosensitivity of upper limb nerves.
METHODS


In this secondary analysis of a randomized, single-blind, placebo-controlled crossover study, 21 breast cancer survivors with stage I-IIIA cancer were randomly allocated to an experimental group (30 minutes of myofascial induction session) or placebo control group (unplugged pulsed 30 minutes of shortwave therapy), with a 4-week washout period between sessions that occurred in a physical therapy laboratory in the Health Science Faculty (University of Granada, Spain). Range of motion (universal goniometry), structural differentiation, symptoms (yes/no), and pressure pain thresholds (electronic algometry) were assessed during neurodynamic tests and attitude toward massage scale as covariate.
RESULTS


An analysis of covariance revealed significant time × group interactions for range of motion in affected upper limb nerves (median, P < .001; radial, P = .036; ulnar, P = .002), but not for nonaffected upper limb nerves (median, P = .083; radial, P = .072; ulnar, P = .796). A χ 2  or Fisher exact test, as appropriate, also revealed a significant difference (P = .044) in sensitivity for the affected upper limb ulnar nerve in the experimental group, whereas the rest of the assessed nerves (affected and nonaffected upper limb nerves) showed no significant changes in either the experimental or control groups (P > .05). An analysis of covariance revealed no significant interactions on pressure pain thresholds over the nerves for affected (all P > .05) and nonaffected (all P > .05) upper limb nerves.
CONCLUSION


A single myofascial induction session may partially improve mechanosensitivity of median, radial, and ulnar nerves and yield positive effects on symptom mechanosensitivity, especially regarding the ulnar nerve in breast cancer survivors.",2020,"An analysis of covariance revealed no significant interactions on pressure pain thresholds over the nerves for affected (all P > .05) and nonaffected (all P > .05) upper limb nerves.
","['Breast Cancer Survivors', '21 breast cancer survivors with stage I-IIIA cancer']","['placebo control group (unplugged pulsed 30 minutes of shortwave therapy', 'myofascial induction', 'Single Myofascial Induction Session', 'placebo']","['pressure pain thresholds', 'Range of motion (universal goniometry), structural differentiation, symptoms (yes/no), and pressure pain thresholds (electronic algometry', 'Neural Mechanosensitivity', 'mechanosensitivity of median, radial, and ulnar nerves']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0037000', 'cui_str': 'Short Wave Therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0041602', 'cui_str': 'Structure of ulnar nerve'}]",21.0,0.0523857,"An analysis of covariance revealed no significant interactions on pressure pain thresholds over the nerves for affected (all P > .05) and nonaffected (all P > .05) upper limb nerves.
","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Castro-Martín', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Galiano-Castillo', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain; Instituto Biosanitario Granada, Granada, Spain. Electronic address: noeliagaliano@ugr.es.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Ortiz-Comino', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cantarero-Villanueva', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain; Instituto Biosanitario Granada, Granada, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lozano-Lozano', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain; Instituto Biosanitario Granada, Granada, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Arroyo-Morales', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain; Instituto Biosanitario Granada, Granada, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernández-Lao', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain; Instituto Mixto Universitario Deporte y Salud, Granada, Spain; Instituto Biosanitario Granada, Granada, Spain.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.03.016']
1528,32705460,Parent Management Training Oregon Model and Family-Based Services as Usual for Behavioral Problems in Youth: A National Randomized Controlled Trial in Denmark.,"This randomized control trial used intent-to-treat analyses to compare parent management training-Oregon model (PMTO) (N = 64) to family-based services as usual (SAU) (N = 62) in 3.5-13-year-old children and their families in Denmark. Outcomes were parent report of child internalizing and externalizing problems, parenting efficacy, parenting stress, parent sense of coherence, parent-report of life satisfaction, and parental depressive symptoms. Outcomes were measured at pretreatment, post-treatment, and 18-20 months post-treatment. Results demonstrated that both PMTO and family-based SAU resulted in significant improvements in child externalizing and internalizing problems, parenting efficacy, as well as parent-reported stress and depressive symptoms, life satisfaction, and aspects of sense of cohesion. Effect sizes at post-treatment and follow-up were in the small to moderate range, consistent with prior PMTO evaluations. However, there were no significant differences between PMTO and family-based SAU. Further research on the process and content of family-based SAU is needed to determine how this approach overlaps with and is distinct from PMTO.",2020,"Results demonstrated that both PMTO and family-based SAU resulted in significant improvements in child externalizing and internalizing problems, parenting efficacy, as well as parent-reported stress and depressive symptoms, life satisfaction, and aspects of sense of cohesion.","['Youth', 'N\u2009=\u200964) to family-based services as usual (SAU) (N\u2009=\u200962) in 3.5-13-year-old children and their families in Denmark']",['parent management training-Oregon model (PMTO'],"['child internalizing and externalizing problems, parenting efficacy, parenting stress, parent sense of coherence, parent-report of life satisfaction, and parental depressive symptoms', 'child externalizing and internalizing problems, parenting efficacy, as well as parent-reported stress and depressive symptoms, life satisfaction, and aspects of sense of cohesion']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",,0.0611722,"Results demonstrated that both PMTO and family-based SAU resulted in significant improvements in child externalizing and internalizing problems, parenting efficacy, as well as parent-reported stress and depressive symptoms, life satisfaction, and aspects of sense of cohesion.","[{'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Scavenius', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Chacko', 'Affiliation': 'New York University, New York, NY, USA. anil.chacko@nyu.edu.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Lindberg', 'Affiliation': 'Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Granski', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Vardanian', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Maiken', 'Initials': 'M', 'LastName': 'Pontoppidan', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Hansen', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark.'}, {'ForeName': 'Misja', 'Initials': 'M', 'LastName': 'Eiberg', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark.'}]",Child psychiatry and human development,['10.1007/s10578-020-01028-y']
1529,32701984,Acupuncture in persons with an increased stress level-Results from a randomized-controlled pilot trial.,"BACKGROUND


In today's Western societies a high percentage of people experience increased or chronic stress. Acupuncture could serve as treatment for persons affected adversely by the increased stress.
METHODS


The AkuRest study was a two-centre randomized controlled pilot study in adult persons with increased stress levels. Participants were randomly allocated to one of three groups: verum acupuncture treatment, sham acupuncture, and a waiting control group. The feasibility of the study was assessed. In addition, effects on stress level (measured by the Perceived Stress Questionnaire (PSQ-20)) and other variables were assessed at the end of treatment and a 3-month follow-up.
RESULTS


Altogether, N = 70 persons were included in the study. At the end of the treatment 15.7% were lost to follow-up. The adherence to the protocol was good: 82.9% of the participants completed 100% of their treatment. The stress level of the participants was high at baseline (mean PSQ-20 score 75.5, SD = 8.2). Effect sizes (ES) at T1 showed that verum and sham acupuncture were superior to the waiting condition in reducing stress (ES (verum) = -1.39, 95%-CI = [-2.11; -0.67]: ES (sham) = -1.12, CI = [-1.78;-0.44]). At follow-up, effect sizes were in favour of the verum group (as compared to sham). However, confidence intervals and t-tests showed that these differences were not significant.
CONCLUSION


The pilot study demonstrated the feasibility of the acupuncture RCT in persons with increased stress levels. Estimated parameters can be used to design a larger RCT to prove the-here indicated-efficacy of verum acupuncture to decrease stress.
TRIAL REGISTRATION NUMBER


ISRCTN15259166.",2020,Effect sizes (ES) at T1 showed that verum and sham acupuncture were superior to the waiting condition in reducing stress (ES (verum) =,"['persons with increased stress levels', 'persons with an increased stress level', 'Altogether, N = 70 persons were included in the study', 'adult persons with increased stress levels']","['acupuncture RCT', 'verum and sham acupuncture', 'Acupuncture', 'verum acupuncture', 'verum acupuncture treatment, sham acupuncture, and a waiting control group']","['Perceived Stress Questionnaire (PSQ-20', 'stress level']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",70.0,0.0786007,Effect sizes (ES) at T1 showed that verum and sham acupuncture were superior to the waiting condition in reducing stress (ES (verum) =,"[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Wild', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Medical University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Brenner', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Medical University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Joos', 'Affiliation': 'Institute for General Practice and Interprofessional Care, Medical University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Samstag', 'Affiliation': 'Institute of Immunology, Section Molecular Immunology, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Buckert', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Medical University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Valentini', 'Affiliation': 'Institute for General Practice and Interprofessional Care, Medical University Hospital Tübingen, Tübingen, Germany.'}]",PloS one,['10.1371/journal.pone.0236004']
1530,32708894,"Effects of Ibuprofen Intake in Muscle Damage, Body Temperature and Muscle Power in Paralympic Powerlifting Athletes.","The aim of this study is to evaluate the effect of ingesting ibuprofen on post-workout recovery of muscle damage, body temperature and muscle power indicators in Paralympic powerlifting athletes. The study was carried out with eight Paralympic powerlifting athletes (aged 27.0 ± 5.3 years and 79.9 ± 25.5 kg of body mass) competing at the national level, with a minimum training experience of 12 months, who all submitted to two experimental conditions: Ibuprofen (2 × 00 mg) and control. The maximal isometric force of the upper limbs and rate of force development, thermography, and serum biochemical analyzes of creatine kinase, lactate dehydrogenase, aspartate aminotransferase and alanine aminotransferase were measured before, after, 24 h after and 48 h after the intervention. Maximal isometric force only decreased in the placebo condition, which increased back to baseline levels, while no substantial decline in baseline force was seen in the ibuprofen condition, although no effect for exercise condition was detected. After the exercise, the rate of force development decreased significantly for both conditions and did not exceed baseline levels again after 48 h. Muscle temperature decreased significantly at 48-h post-exercise in the placebo condition, when compared with the previous day of measurement; and deltoid muscle temperature at 48-h post-exercise was higher with the ibuprofen condition. Although the results indicate some positive effects of ibuprofen use, they do not enable a clear statement regarding its positive effects on muscle function and muscle damage. Ibuprofen seems to have caused a delay in the anti-inflammatory response following exercise.",2020,"Maximal isometric force only decreased in the placebo condition, which increased back to baseline levels, while no substantial decline in baseline force was seen in the ibuprofen condition, although no effect for exercise condition was detected.","['Paralympic powerlifting athletes', 'eight Paralympic powerlifting athletes (aged 27.0 ± 5.3 years and 79.9 ± 25.5 kg of body mass) competing at the national level, with a minimum training experience of 12 months, who all submitted to two experimental conditions', 'Paralympic Powerlifting Athletes']","['ingesting ibuprofen', 'Ibuprofen (2 × 00 mg) and control', 'ibuprofen', 'Ibuprofen']","['deltoid muscle temperature', 'Muscle temperature', 'Muscle Damage, Body Temperature and Muscle Power', 'Maximal isometric force', 'rate of force development', 'maximal isometric force of the upper limbs and rate of force development, thermography, and serum biochemical analyzes of creatine kinase, lactate dehydrogenase, aspartate aminotransferase and alanine aminotransferase']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0039810', 'cui_str': 'Thermography'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",,0.0728658,"Maximal isometric force only decreased in the placebo condition, which increased back to baseline levels, while no substantial decline in baseline force was seen in the ibuprofen condition, although no effect for exercise condition was detected.","[{'ForeName': 'Guacira S', 'Initials': 'GS', 'LastName': 'Fraga', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Felipe J', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Dihogo G', 'Initials': 'DG', 'LastName': 'Matos', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GEPEPS), Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Anderson C', 'Initials': 'AC', 'LastName': 'Marçal', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Jymmys L', 'Initials': 'JL', 'LastName': 'Santos', 'Affiliation': 'Northeast Network in Biotechnology (RENORBIO), Federal University of Sergipe, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Raphael F', 'Initials': 'RF', 'LastName': 'Souza', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Carneiro', 'Affiliation': 'Department of Physical Education, State University of Montes Claros, Minas Gerais 30000-000, Brazil.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Vasconcelos', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Marzo E', 'Initials': 'ME', 'LastName': 'Da Silva-Grigoletto', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'van den Tillaar', 'Affiliation': 'Department of Sport Sciences and Physical Education, Nord University, 7600 Levanger, Norway.'}, {'ForeName': 'Breno T', 'Initials': 'BT', 'LastName': 'Cabral', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal 59072970, Brazil.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Reis', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University of Trás-os-Montes and Alto Douro, 5000-412 Vila Real, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17145157']
1531,32708898,Sex Differences in Maintaining the Requested Handgrip Force Enhanced by Auditory or Visual Feedback.,"Thus far, the differences in effect of auditory or visual feedback in motor learning have presented results derived from mixed groups and sex differences have not been considered. However, perception and processing of auditory stimuli and performance of visual motor tasks appear to be sex-related. The purpose of this study was to investigate the learning of the simple motor task of maintaining a requested handgrip force in separate male and female groups. A total of 31 volunteers (15 males, 16 females) were randomly assigned to one of four experimental groups with defined sex and training conditions (audio or visual feedback). Participants performed training sessions over a period of six days, for which auditory or visual feedback was provided, and the effectiveness of both types of signals was compared. The evident learning effect was found in all groups, and the main effect of sex was significant among visual groups in favor of the males ( p  < 0.05). On the other hand, the main effect of feedback conditions was found to be significant among females, beneficially in the case of auditory displays ( p  < 0.05). The results lead to the conclusion that an equal number of males and females in mixed experimental groups may be supportive to obtain reliable results. Moreover, in motor-learning studies conducted on females only, a design including auditory feedback would be more suitable.",2020,"The evident learning effect was found in all groups, and the main effect of sex was significant among visual groups in favor of the males ( p  < 0.05).","['31 volunteers (15 males, 16 females', 'separate male and female groups']",['defined sex and training conditions (audio or visual feedback'],"['evident learning effect', 'perception and processing of auditory stimuli and performance of visual motor tasks']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",31.0,0.0238798,"The evident learning effect was found in all groups, and the main effect of sex was significant among visual groups in favor of the males ( p  < 0.05).","[{'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Tarnas', 'Affiliation': 'Department of Physical Education and Lifelong Sports, Poznan University of Physical Education, Królowej Jadwigi 27/39, 61-871 Poznań, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Stemplewski', 'Affiliation': 'Department of Physical Activity Sciences and Health Promotion, Poznan University of Physical Education, Królowej Jadwigi 27/39, 61-871 Poznań, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Krutki', 'Affiliation': 'Department of Neurobiology, Poznan University of Physical Education, Królowej Jadwigi 27/39, 61-871 Poznań, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17145158']
1532,32710165,Change in Dynamic Hyperinflation After Bronchoscopic Lung Volume Reduction in Patients with Emphysema.,"BACKGROUND AND PURPOSE


In patients with severe emphysema, dynamic hyperinflation is superimposed on top of already existing static hyperinflation. Static hyperinflation reduces significantly after bronchoscopic lung volume reduction (BLVR). In this study, we investigated the effect of BLVR compared to standard of care (SoC) on dynamic hyperinflation.
METHODS


Dynamic hyperinflation was induced by a manually paced tachypnea test (MPT) and was defined by change in inspiratory capacity (IC) measured before and after MPT. Static and dynamic hyperinflation measurements were performed both at baseline and 6 months after BLVR with endobronchial valves or coils (treatment group) or SoC (control group).
RESULTS


Eighteen patients underwent BLVR (78% female, 57 (43-67) years, FEV 1  25(18-37) %predicted, residual volume 231 (182-376) %predicted). Thirteen patients received SoC (100% female, 59 (44-74) years, FEV 1  25 (19-37) %predicted, residual volume 225 (152-279) %predicted. The 6 months median change in dynamic hyperinflation in the treatment group was: + 225 ml (range - 113 to + 803) (p < 0.01) vs 0 ml (- 1067 to + 500) in the control group (p = 0.422). An increase in dynamic hyperinflation was significantly associated with a decrease in residual volume (r = - 0.439, p < 0.01).
CONCLUSION


Bronchoscopic lung volume reduction increases the ability for dynamic hyperinflation in patients with severe emphysema. We propose this is a consequence of improved static hyperinflation.",2020,"An increase in dynamic hyperinflation was significantly associated with a decrease in residual volume (r = - 0.439, p < 0.01).
","['patients with severe emphysema', 'Patients with Emphysema']","['endobronchial valves or coils (treatment group) or SoC (control group', 'Bronchoscopic lung volume reduction', 'BLVR', 'standard of care (SoC', 'Static hyperinflation']","['Dynamic Hyperinflation', 'inspiratory capacity (IC', 'residual volume', 'dynamic hyperinflation', 'Static and dynamic hyperinflation measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}]","[{'cui': 'C3880733', 'cui_str': 'Endobronchial valve'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3697654', 'cui_str': 'Bronchoscopic lung volume reduction'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",18.0,0.0337627,"An increase in dynamic hyperinflation was significantly associated with a decrease in residual volume (r = - 0.439, p < 0.01).
","[{'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'van Dijk', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, Research Institute for Asthma and COPD Groningen, University of Groningen, Groningen, The Netherlands. m.van.dijk05@umcg.nl.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Klooster', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, Research Institute for Asthma and COPD Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jorine E', 'Initials': 'JE', 'LastName': 'Hartman', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, Research Institute for Asthma and COPD Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Nick H T', 'Initials': 'NHT', 'LastName': 'Ten Hacken', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, Research Institute for Asthma and COPD Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'Slebos', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, Research Institute for Asthma and COPD Groningen, University of Groningen, Groningen, The Netherlands.'}]",Lung,['10.1007/s00408-020-00382-x']
1533,32706953,Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19.,"BACKGROUND


Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.
METHODS


We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.
RESULTS


A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P = 1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P = 1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
CONCLUSIONS


Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.).",2020,"Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
","['hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen', 'Mild-to-Moderate Covid-19', 'patients with coronavirus disease 2019 (Covid-19', 'patients hospitalized with mild-to-moderate Covid-19', '667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis']","['Hydroxychloroquine and azithromycin', 'hydroxychloroquine', 'hydroxychloroquine plus azithromycin', 'Hydroxychloroquine with or without Azithromycin', 'azithromycin', 'standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine']","['safety and efficacy', 'Safety', 'Prolongation of the corrected QT interval and elevation of liver-enzyme levels', 'clinical status at 15 days as assessed with the use of a seven-level ordinal scale']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",667.0,0.251782,"Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
","[{'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Regis G', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Luciano C P', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Marcadenti', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'Kawano-Dourado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Lisboa', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Debora L M', 'Initials': 'DLM', 'LastName': 'Junqueira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Pedro G M', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Tramujas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Erlon O', 'Initials': 'EO', 'LastName': 'Abreu-Silva', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Ligia N', 'Initials': 'LN', 'LastName': 'Laranjeira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Aline T', 'Initials': 'AT', 'LastName': 'Soares', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Leandro S', 'Initials': 'LS', 'LastName': 'Echenique', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Adriano J', 'Initials': 'AJ', 'LastName': 'Pereira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Flávio G R', 'Initials': 'FGR', 'LastName': 'Freitas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Otávio C E', 'Initials': 'OCE', 'LastName': 'Gebara', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Vicente C S', 'Initials': 'VCS', 'LastName': 'Dantas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Eveline P', 'Initials': 'EP', 'LastName': 'Milan', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Golin', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Fábio F', 'Initials': 'FF', 'LastName': 'Cardoso', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Israel S', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Conrado R', 'Initials': 'CR', 'LastName': 'Hoffmann Filho', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Adrian P M', 'Initials': 'APM', 'LastName': 'Kormann', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Roberto B', 'Initials': 'RB', 'LastName': 'Amazonas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Monalisa F', 'Initials': 'MF', 'LastName': 'Bocchi de Oliveira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa-Neto', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Maicon', 'Initials': 'M', 'LastName': 'Falavigna', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2019014']
1534,32739319,Effect of baseline sarcopenia on adjuvant treatment for D2 dissected gastric cancer: Analysis of the ARTIST phase III trial.,"BACKGROUND AND PURPOSE


This study evaluated the clinical significance of preoperative sarcopenia according to adjuvant concurrent chemo-radiotherapy (XP-RT) or chemotherapy alone (XP) in the D2 dissected gastric cancer patient cohort of the ARTIST trial.
MATERIALS AND METHODS


Skeletal muscles at the L3 vertebra level from preoperative computed tomography images among the ARTIST trial participants were measured using validated in-house software. Skeletal muscle index (SMI) was defined as the measured skeletal muscle area divided by the square of the height, and sarcopenia was defined according to the Korean-specific cutoff, i.e. L3 SMI ≤ 49 cm 2 /m 2  for men and ≤31 cm 2 /m 2  for women.
RESULTS


Among the 440 patients in whom we were able to evaluate L3 SMI, 75 (17.0%) met the definition for preoperative sarcopenia. No differences in treatment-related toxicities or treatment compliance were observed according to the presence of preoperative sarcopenia in either treatment arm. In the subgroup of patients without preoperative sarcopenia, recurrence was significantly lower in the XP-RT arm than that in the XP arm (p = 0.02). Recurrence-free survival (RFS) was also significantly higher in the XP-RT arm (p = 0.02, hazard ratio 0.633, 95% confidence interval 0.433-0.926) in this subgroup. In the multivariate analysis, and after adjusting for significant prognostic factors, the superior outcome of XP-RT arm regarding RFS was maintained in the subgroup of the patients without preoperative sarcopenia.
CONCLUSIONS


Superior clinical outcomes of adjuvant XP-RT over XP were only observed in patients without preoperative sarcopenia.",2020,No differences in treatment-related toxicities or treatment compliance were observed according to the presence of preoperative sarcopenia in either treatment arm.,"['Skeletal muscles at the L3 vertebra level from preoperative computed tomography images among the ARTIST trial participants were measured using validated in-house software', '440 patients in whom we were able to evaluate L3 SMI, 75 (17.0%) met the definition for preoperative sarcopenia', 'D2 dissected gastric cancer', 'D2 dissected gastric cancer patient cohort of the ARTIST trial']","['adjuvant concurrent chemo-radiotherapy (XP-RT) or chemotherapy alone (XP', 'baseline sarcopenia']","['Skeletal muscle index (SMI', 'preoperative sarcopenia, recurrence', 'Recurrence-free survival (RFS']","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0223522', 'cui_str': 'Bone structure of L3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0402043', 'cui_str': 'Artist'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",440.0,0.0407846,No differences in treatment-related toxicities or treatment compliance were observed according to the presence of preoperative sarcopenia in either treatment arm.,"[{'ForeName': 'Jeong Il', 'Initials': 'JI', 'LastName': 'Yu', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: jeongil.yu@samsung.com.'}, {'ForeName': 'Changhoon', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Kang', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Tae', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung Yong', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Sung', 'Initials': 'TS', 'LastName': 'Sohn', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'An', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Min Gew', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Moon', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': 'Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyoung-Mee', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Heewon', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Kyunga', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Heerim', 'Initials': 'H', 'LastName': 'Nam', 'Affiliation': 'Department of Radiation Oncology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Do Hoon', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: dh8.lim@samsung.com.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.07.043']
1535,32739537,Percutaneous complete revascularization strategies using sirolimus-eluting biodegradable polymer-coated stents in patients presenting with acute coronary syndrome and multivessel disease: Rationale and design of the BIOVASC trial.,"BACKGROUND


Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued.
METHODS


The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure.
CONCLUSIONS


The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).",2020,The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).,"['acute coronary syndrome patients with multivessel disease', 'patients presenting with acute coronary syndrome and multivessel disease', 'patients with an acute coronary syndrome and multivessel disease', '1,525 patients 1:1 to', 'Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain']","['immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm', 'sirolimus-eluting biodegradable polymer-coated stents']","['composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1525.0,0.0551991,The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).,"[{'ForeName': 'Wijnand K', 'Initials': 'WK', 'LastName': 'den Dekker', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands. Electronic address: w.dendekker@erasmusmc.nl.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bennett', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabate', 'Affiliation': 'Cardiovascular institute, Hospital Clinic University of Barcelona, IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Rutger J', 'Initials': 'RJ', 'LastName': 'van Bommel', 'Affiliation': 'Department of Cardiology, Tergooi Blaricum, Blaricum, the Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Daemen', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vrolix', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Cummins', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Mattie J', 'Initials': 'MJ', 'LastName': 'Lenzen', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Boersma', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Diletti', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.06.006']
1536,32739652,"Extended antiplatelet therapy with clopidogrel alone versus clopidogrel plus aspirin after completion of 9- to 12-month dual antiplatelet therapy for acute coronary syndrome patients with both high bleeding and ischemic risk. Rationale and design of the OPT-BIRISK double-blinded, placebo-controlled randomized trial.","BACKGROUND


Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone for prevention ischemic events in patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention. However, the optimal antiplatelet strategy for ACS patients with both high bleeding and high ischemic risks is unclear.
STUDY DESIGN


The OPT-BIRISK trial is a multicenter, double-blinded, placebo-controlled randomized study designed to test the superiority of extended antiplatelet therapy with clopidogrel monotherapy compared with aspirin and clopidogrel for reduction of bleeding events in ACS patients with both high bleeding and high ischemic risks (""bi-risk""). A total of 7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS will be randomized to receive clopidogrel monotherapy or aspirin plus clopidogrel for 9 months followed by aspirin monotherapy for 3 months. The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization. The key secondary end point is major adverse cardiac and cerebral events at 9 months after randomization, defined as a composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization.
CONCLUSIONS


OPT-BIRISK is the first large-scale randomized trial aimed to explore the optimal antiplatelet strategy for bi-risk ACS patients after percutaneous coronary intervention in current clinical practice. The results will add evidence regarding de-escalation antiplatelet therapy for patients at special risk.",2020,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","['7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS', 'patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention', 'acute coronary syndrome patients with both high bleeding and ischemic risk', 'patients at special risk', 'ACS patients with both high bleeding and high ischemic risks (""bi-risk']","['clopidogrel alone versus clopidogrel plus aspirin', 'aspirin and a P2Y12 inhibitor', 'aspirin monotherapy', 'aspirin and clopidogrel', 'clopidogrel monotherapy or aspirin plus clopidogrel', 'placebo']","['major adverse cardiac and cerebral events', 'composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization', 'bleeding events', 'Bleeding Academic Research Consortium type 2, 3, or 5 bleedings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",7700.0,0.0625651,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Quanmin', 'Initials': 'Q', 'LastName': 'Jing', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Shubing', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Fu Wai Hospital of Chinese Academy of Medical Science, Beijing, China.'}, {'ForeName': 'Shaoliang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Nanjing First Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.07.005']
1537,32702315,"Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial.","BACKGROUND


Peanut allergy is the leading cause of food-related anaphylaxis. Current management options can negatively affect food allergy-related quality of life. We aimed to investigate the efficacy of an investigational oral biologic drug (AR101).
METHODS


The AR101 Trial in Europe Measuring Oral Immunotherapy Success in peanut-allergic children (ARTEMIS) trial was a multicentre, double-blind, randomised, placebo-controlled phase 3 trial done at 18 hospitals in Ireland, France, Germany, Italy, Spain, Sweden, and the UK. Children and adolescents with peanut allergy, aged 4-17 years, who developed dose-limiting symptoms to 300 mg or less peanut protein (equivalent to approximately one peanut kernel) during a double-blind placebo-controlled food challenge test at study entry were enrolled. Participants were randomly assigned (3:1) to receive daily doses of either AR101 oral immunotherapy (AR101 group) or a taste-masked placebo (placebo group). All participants, investigators, and care providers were masked to treatment allocation until the study was completed. Doses were increased every 2 weeks over 6 months until a dose of 300 mg was reached and maintained for 3 months. The primary endpoint was the proportion of participants in the intention-to-treat or safety population (defined as those participants who had been randomly assigned and had received at least one dose of the assigned drug) who could consume a single dose of 1000 mg (cumulative dose 2043 mg) peanut protein without developing dose-limiting allergic symptoms at an exit double-blind placebo-controlled food challenge after 9 months of treatment. Additional endpoints included safety (ie, the frequency and severity of adverse events) and changes in food allergy-related quality of life, assessed by use of age-appropriate Food Allergy Quality of Life Questionnaires (FAQLQs) and the Food Allergy Independent Measure (FAIM). The study is registered with ClinicalTrials.gov, NCT03201003, and is completed.
FINDINGS


Between June 12, 2017, and Feb 15, 2018, 227 patients were screened, of whom 175 were randomly assigned to the AR101 group (n=132) and the placebo group (n=43). All primary and secondary endpoints were met. 77 (58%) of 132 participants in the AR101 group tolerated 1000 mg peanut protein at the exit food challenge versus one (2%) of 43 participants in the placebo group (AR101-placebo treatment difference 56·0% [95% CI 44·1-65·2], p<0·0001). Adverse events were reported by almost all participants. The maximum severity of adverse events reported was mild or moderate for most participants who received AR101 (mild, 66 [50%] of 132 participants; moderate, 63 [48%]; and severe, one [1%]) or placebo (mild, 24 [56%] of 43 participants; moderate, 18 [42%]; severe, none). Participants aged 8-12 years in the AR101 group reported improvements that exceeded the minimum clinically important difference between the two groups across all FAQLQ domains. Additionally, participants in the AR101 group and their caregivers reported improvements that exceeded the minimum clinically important difference in FAIM domains related to the perceived likelihood and outcomes of a severe allergic reaction.
INTERPRETATION


AR101 oral immunotherapy treatment led to rapid desensitisation to peanut protein, with a predictable safety profile that improved with treatment, and an associated improvement in self-reported and caregiver-reported food allergy-related quality of life. These patient-oriented outcomes provide invaluable data to help physicians, patients, and caregivers make informed, shared decisions on the management of peanut allergy.
FUNDING


Aimmune Therapeutics.",2020,Participants aged 8-12 years in the AR101 group reported improvements that exceeded the minimum clinically important difference between the two groups across all FAQLQ domains.,"['European children with a peanut allergy (ARTEMIS', 'peanut-allergic children', 'Between June 12, 2017, and Feb 15, 2018, 227 patients were screened, of whom 175 were randomly assigned to the AR101 group (n=132) and the', 'Children and adolescents with peanut allergy, aged 4-17 years, who developed dose-limiting symptoms to 300 mg or less peanut protein (equivalent to approximately one peanut kernel) during a double-blind placebo-controlled food challenge test at study entry were enrolled', '18 hospitals in Ireland, France, Germany, Italy, Spain, Sweden, and the UK']","['AR101 oral immunotherapy (AR101 group) or a taste-masked placebo (placebo', 'investigational oral biologic drug (AR101', 'could consume a single dose of 1000 mg (cumulative dose 2043 mg) peanut protein without developing dose-limiting allergic symptoms at an exit double-blind placebo', 'oral immunotherapy with AR101', 'placebo']","['maximum severity of adverse events', 'proportion of participants in the intention-to-treat or safety population', 'Adverse events', 'safety (ie, the frequency and severity of adverse events) and changes in food allergy-related quality of life, assessed by use of age-appropriate Food Allergy Quality of Life Questionnaires', 'Efficacy and safety', 'severe allergic reaction', 'FAIM domains', 'FAQLQs) and the Food Allergy Independent Measure (FAIM']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4553887', 'cui_str': 'Biologics'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",227.0,0.78594,Participants aged 8-12 years in the AR101 group reported improvements that exceeded the minimum clinically important difference between the two groups across all FAQLQ domains.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': ""O'B Hourihane"", 'Affiliation': 'Paediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin, Ireland; Paediatrics and Child Health, INFANT Centre and HRB Clinical Research Facility, University College Cork, Cork, Ireland.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Beyer', 'Affiliation': 'Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Allyah', 'Initials': 'A', 'LastName': 'Abbas', 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fernández-Rivas', 'Affiliation': 'Hospital Clínico San Carlos, UCM, IDISSC, ARADyAL, Madrid, Spain.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Turner', 'Affiliation': 'Imperial College, London, London, UK.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Blumchen', 'Affiliation': 'Department of Children and Adolescent Medicine, Division of Allergology, Pneumology and Cystic Fibrosis, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Nilsson', 'Affiliation': ""Clinical Science and Education, Karolinska Institutet, Sachs' Children and Youth Hospital, Sodersjukhuset, Stockholm, Sweden.""}, {'ForeName': 'Maria D', 'Initials': 'MD', 'LastName': 'Ibáñez', 'Affiliation': 'H. Infantil Universitario Niño Jesús, ARADyAL-RETICs Instituto de Salud Carlos III, IIS-P, FibHNJ, Madrid, Spain.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Deschildre', 'Affiliation': 'Université de Lille, CHU Lille, Pediatric Pulmonology and Allergy Unit, Hôpital Jeanne de Flandre, Lille, France.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Muraro', 'Affiliation': 'Food Allergy Referral Centre Veneto Region, Department of Woman and Child Health, Padua University Hospital, Padua, Italy.'}, {'ForeName': 'Vibha', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust and Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, UK.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Erlewyn-Lajeunesse', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Zubeldia', 'Affiliation': 'Hospital GU Gregorio Marañón, and Biomedical Research Network on Rare Diseases, Madrid, Spain.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'De Blay', 'Affiliation': 'University Hospital Strasbourg, Strasbourg, France.'}, {'ForeName': 'Christine D', 'Initials': 'CD', 'LastName': 'Sauvage', 'Affiliation': 'Hôpital Saint-Vincent, Saint Antoine, Lille, France.'}, {'ForeName': 'Aideen', 'Initials': 'A', 'LastName': 'Byrne', 'Affiliation': ""National Children's Research Centre, Dublin, Ireland.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'James Paget University Hospitals NHS Foundation Trust, Great Yarmouth, UK.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Boralevi', 'Affiliation': 'CIC 1401, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'DunnGalvin', 'Affiliation': 'Paediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin, Ireland; Department of Pediatrics and Pediatric Infectious Diseases, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': ""O'Neill"", 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Norval', 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vereda', 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Skeel', 'Affiliation': 'Aimmune Therapeutics, London, UK.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Adelman', 'Affiliation': 'Aimmune Therapeutics, Brisbane, CA, USA; Department of Medicine, University of California San Francisco, San Francisco, CA, USA. Electronic address: dadelman@aimmune.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'du Toit', 'Affiliation': ""Evelina London, Children's Allergy Service, Guy's and St Thomas' Hospital, London, UK; Department of Women and Children's Health (Paediatric Allergy), School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30234-0']
1538,32702335,"Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Studies have suggested that fluoxetine could improve neurological recovery after stroke. The Efficacy oF Fluoxetine-a randomisEd Controlled Trial in Stroke (EFFECTS) trial aimed to assess whether administration of oral fluoxetine for 6 months after acute stroke improves functional outcome.
METHODS


EFFECTS was an investigator-led, multicentre, randomised, placebo-controlled, double-blind, parallel group trial that enrolled patients aged 18 years or older between 2 and 15 days after stroke onset in 35 stroke and rehabilitation centres in Sweden. Eligible patients had a clinical diagnosis of ischaemic or intracerebral haemorrhage, brain imaging that was consistent with intracerebral haemorrhage or ischaemic stroke, and had at least one persisting focal neurological deficit. A web-based randomisation system that incorporated a minimisation algorithm was used to randomly assign (1:1) participants to receive oral fluoxetine 20 mg once daily or matching placebo capsules for 6 months. Patients, care providers, investigators, and outcomes assessors were masked to the allocation. The primary outcome was functional status, measured with the modified Rankin Scale (mRS) at 6 months, analysed in all patients with available mRS data at the 6-month follow-up; we did an ordinal analysis adjusted for the minimisation variables used in the randomisation. This trial is registered with EudraCT, 2011-006130-16; ISRCTN, 13020412; and ClinicalTrials.gov, NCT02683213.
FINDINGS


Between Oct 20, 2014, and June 28, 2019, 1500 patients were enrolled, of whom 750 were randomly assigned to fluoxetine and 750 were randomly assigned to placebo. At 6 months, mRS data were available for 737 (98%) patients in the fluoxetine group and 742 (99%) patients in the placebo group. There was no effect of fluoxetine on the primary outcome-distribution across mRS score categories-compared with placebo (adjusted common odds ratio 0·94 [95% CI 0·78 to 1·13]; p=0·42). The proportion of patients with a new diagnosis of depression was lower with fluoxetine than with placebo (54 [7%] patients vs 81 [11%] patients; difference -3·60% [-6·49 to -0·71]; p=0·015), but fluoxetine was associated with more bone fractures (28 [4%] vs 11 [2%]; difference 2·27% [0·66 to 3·87]; p=0·0058) and hyponatraemia (11 [1%] vs one [<1%]; difference 1·33% [0·43 to 2·23]; p=0·0038) at 6 months.
INTERPRETATION


Functional outcome after acute stroke did not improve with oral fluoxetine 20 mg once daily for 6 months. Fluoxetine reduced the occurrence of depression but increased the risk of bone fractures and hyponatraemia. Our results do not support the use of fluoxetine after acute stroke.
FUNDING


The Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Brain Foundation, the Swedish Society of Medicine, King Gustav V and Queen Victoria's Foundation of Freemasons, and the Swedish Stroke Association (STROKE-Riksförbundet).",2020,There was no effect of fluoxetine on the primary outcome-distribution across mRS score categories-compared with placebo (adjusted common odds ratio 0·94 [95% CI 0·78 to 1·13]; p=0·42).,"['enrolled patients aged 18 years or older between 2 and 15 days after stroke onset in 35 stroke and rehabilitation centres in Sweden', 'Eligible patients had a clinical diagnosis of ischaemic or intracerebral haemorrhage, brain imaging that was consistent with intracerebral haemorrhage or ischaemic stroke, and had at least one persisting focal neurological deficit', '1500 patients were enrolled, of whom 750 were randomly assigned to', 'Between Oct 20, 2014, and June 28, 2019']","['oral fluoxetine', 'fluoxetine', 'oral fluoxetine 20 mg once daily or matching placebo', 'Fluoxetine', 'placebo']","['occurrence of depression', 'functional outcome', 'bone fractures', 'risk of bone fractures and hyponatraemia', 'Safety and efficacy', 'proportion of patients with a new diagnosis of depression', 'functional status, measured with the modified Rankin Scale (mRS', 'neurological recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0986112', 'cui_str': 'Fluoxetine 20 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",1500.0,0.629145,There was no effect of fluoxetine on the primary outcome-distribution across mRS score categories-compared with placebo (adjusted common odds ratio 0·94 [95% CI 0·78 to 1·13]; p=0·42).,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30219-2']
1539,32702334,"Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Trials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to show if daily oral fluoxetine for 6 months after stroke improves functional outcome in an ethnically diverse population.
METHODS


AFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial done in 43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten). Eligible patients were adults (aged ≥18 years) with a clinical diagnosis of acute stroke in the previous 2-15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more. Patients were randomly assigned 1:1 via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20 mg capsules or matching placebo for 6 months. Patients, carers, investigators, and outcome assessors were masked to the treatment allocation. The primary outcome was functional status, measured by the mRS, at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Primary and safety analyses were done according to the patient's treatment allocation. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12611000774921.
FINDINGS


Between Jan 11, 2013, and June 30, 2019, 1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706), of whom 642 were randomly assigned to fluoxetine and 638 were randomly assigned to placebo. Mean duration of trial treatment was 167 days (SD 48·1). At 6 months, mRS data were available in 624 (97%) patients in the fluoxetine group and 632 (99%) in the placebo group. The distribution of mRS categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0·94, 95% CI 0·76-1·15; p=0·53). Compared with patients in the placebo group, patients in the fluoxetine group had more falls (20 [3%] vs seven [1%]; p=0·018), bone fractures (19 [3%] vs six [1%]; p=0·014), and epileptic seizures (ten [2%] vs two [<1%]; p=0·038) at 6 months.
INTERPRETATION


Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures. These results do not support the use of fluoxetine to improve functional outcome after stroke.
FUNDING


National Health and Medical Research Council of Australia.",2020,"Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures.","['43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten', 'ethnically diverse population', 'Eligible patients were adults (aged ≥18 years) with a clinical diagnosis of acute stroke in the previous 2-15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more', '1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706', 'after acute stroke (AFFINITY', 'Between Jan 11, 2013, and June 30, 2019']","['FluoxetINe', 'fluoxetine', 'fluoxetine 20 mg capsules or matching placebo', 'Oral fluoxetine', 'placebo']","['functional outcome', 'distribution of mRS categories', 'bone fractures', 'falls', 'Safety and efficacy', 'epileptic seizures', 'risk of falls, bone fractures, and epileptic seizures', 'mRS data']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0986112', 'cui_str': 'Fluoxetine 20 MG'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1280.0,0.655404,"Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30207-6']
1540,32703614,Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence: A Randomized Clinical Trial.,"OBJECTIVE


To investigate the effectiveness of strengthening the hip muscles in addition to strengthening the pelvic floor muscles (PFM) in the treatment of stress urinary incontinence.
METHODS


This study used a prospective, assessor-blind, randomized clinical trial with parallel groups. We randomly allocated 47 individuals with stress urinary incontinence to 2 groups: 1 performing only pelvic floor strengthening exercises (PF, n = 21) and the other performing pelvic floor strengthening exercises plus exercises for the gluteus maximus and medius and hip adductor muscles (PFH, n = 22). Four individuals did not complete the study. Frequency of urine leakage was the primary outcome (3-day voiding diary and a follow-up voiding diary). Secondary outcomes were pelvic floor muscle strength (Ortiz scale, PERFECT scheme [Oxford Scale], and perineometry) and quality of life (QoL; International Consultation on Incontinence Questionnaire-Short Form and King's Health Questionnaire), which were evaluated by a blinded assessor before and after 20 sessions over 10 weeks.
RESULTS


Regarding the daily frequency of urine loss evaluated by the follow-up voiding diary, an effect of group was observed (P < .001), with the PFH group showing a significant decrease in daily loss frequency, although no significant differences were found in the comparison between groups for the 3-day voiding diary, QoL, or functional assessment of the PFM.
CONCLUSION


Strengthening the PFM together with the hip synergic muscles showed better results for frequency of daily urine loss throughout the sessions, although there was no accompanying superiority in improvement of strength, perineometry, or QoL over the group that performed only PFM-strengthening exercises.",2020,"Strengthening the PFM together with the hip synergic muscles showed better results for frequency of daily urine loss throughout the sessions, although there was no accompanying superiority in improvement of strength, perineometry, or QoL over the group that performed only PFM-strengthening exercises.","['Stress Urinary Incontinence', '47 individuals with stress urinary incontinence to 2 groups', 'stress urinary incontinence']","['Pelvic Floor and Hip Muscle Strengthening', 'PFH', '1 performing only pelvic floor strengthening exercises (PF, n\u202f=\u202f21) and the other performing pelvic floor strengthening exercises plus exercises']","['Frequency of urine leakage', 'strength, perineometry, or QoL', 'daily loss frequency', 'frequency of daily urine loss', '3-day voiding diary, QoL, or functional assessment of the PFM', ""pelvic floor muscle strength (Ortiz scale, PERFECT scheme [Oxford Scale], and perineometry) and quality of life (QoL; International Consultation on Incontinence Questionnaire-Short Form and King's Health Questionnaire""]","[{'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0152245', 'cui_str': 'Extravasation of urine'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",47.0,0.0646245,"Strengthening the PFM together with the hip synergic muscles showed better results for frequency of daily urine loss throughout the sessions, although there was no accompanying superiority in improvement of strength, perineometry, or QoL over the group that performed only PFM-strengthening exercises.","[{'ForeName': 'Simone A A', 'Initials': 'SAA', 'LastName': 'Marques', 'Affiliation': 'Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Simone R B da', 'Initials': 'SRBD', 'LastName': 'Silveira', 'Affiliation': 'Department of Obstetrics and Gynecology, Urogynecology Section, University Hospital, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anice C', 'Initials': 'AC', 'LastName': 'Pássaro', 'Affiliation': 'Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Haddad', 'Affiliation': 'Department of Obstetrics and Gynecology, Urogynecology Section, Clinical Hospital, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edmund C', 'Initials': 'EC', 'LastName': 'Baracat', 'Affiliation': 'Department of Obstetrics and Gynecology, Urogynecology Section, University Hospital, University of São Paulo, São Paulo, Brazil; Department of Obstetrics and Gynecology, Urogynecology Section, Clinical Hospital, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Elizabeth A G', 'Initials': 'EAG', 'LastName': 'Ferreira', 'Affiliation': 'Department of Physical Therapy, Speech and Occupational Therapy, School of Medicine, University of São Paulo, São Paulo, Brazil. Electronic address: elferreira@usp.br.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.01.007']
1541,32705393,Inspiratory muscle training improves cerebrovascular and postural control responses during orthostatic stress in older women.,"PURPOSE


We aimed to investigate the effect of inspiratory muscle training (IMT) on, hemodynamic, cerebrovascular and postural balance responses during orthostatic stress, in older women.
METHODS


Fourteen elderly women were assigned to perform IMT at 50% of maximal inspiratory pressure (MIP) (IMT group, n = 8) or placebo training at 5% MIP (Sham group, n = 6), in a counter-balanced order, using an inspiratory threshold device for 4 weeks. During the protocol, MIP was tested weekly once. In a second visit, blood pressure, heart rate, stroke volume, cardiac output, middle cerebral artery blood flow velocity (MCAv), and ventilation parameters were recorded continuously at rest and during orthostatic stress testing, which was conducted on a force plate to measure center-of-pressure (COP) oscillations (postural balance) and the electromyographic activity of the right medial gastrocnemius and tibialis anterior.
RESULTS


IMT increased MIP from second to 4th week. The drops in MCAv, stroke volume, and cardiac output, as well as COP displacements during initial orthostasis decreased post-IMT.
CONCLUSION


IMT improves the interplay of the respiratory pump, hemodynamic, cerebrovascular and postural balance responses during orthostatic stress in older women.",2020,"IMT improves the interplay of the respiratory pump, hemodynamic, cerebrovascular and postural balance responses during orthostatic stress in older women.","['older women', 'Fourteen elderly women']","['IMT at 50% of maximal inspiratory pressure (MIP) (IMT group, n\u2009=\u20098) or placebo training at 5% MIP (Sham group, n\u2009=\u20096), in a counter-balanced order, using an inspiratory threshold device for 4\xa0weeks', 'Inspiratory muscle training', 'inspiratory muscle training (IMT', 'IMT']","['MCAv, stroke volume, and cardiac output, as well as COP displacements', 'cerebrovascular and postural control responses', 'hemodynamic, cerebrovascular and postural balance responses', 'force plate to measure center-of-pressure (COP) oscillations (postural balance) and the electromyographic activity of the right medial gastrocnemius and tibialis anterior', 'blood pressure, heart rate, stroke volume, cardiac output, middle cerebral artery blood flow velocity (MCAv), and ventilation parameters']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0242690', 'cui_str': 'Tibialis anterior muscle structure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",14.0,0.052373,"IMT improves the interplay of the respiratory pump, hemodynamic, cerebrovascular and postural balance responses during orthostatic stress in older women.","[{'ForeName': 'Gabriel Dias', 'Initials': 'GD', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Rua Professor Hernani Pires de Melo, 101, São Domingos, Niteroi, RJ, CEP 24210-130, Brazil.'}, {'ForeName': 'Jonas Lírio', 'Initials': 'JL', 'LastName': 'Gurgel', 'Affiliation': 'Department of Physical Education and Sports, Fluminense Federal University, Niteroi, Brazil.'}, {'ForeName': 'Iuri Dos Santos', 'Initials': 'IDS', 'LastName': 'Galdino', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Rua Professor Hernani Pires de Melo, 101, São Domingos, Niteroi, RJ, CEP 24210-130, Brazil.'}, {'ForeName': 'Antonio Claudio Lucas', 'Initials': 'ACL', 'LastName': 'da Nóbrega', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Rua Professor Hernani Pires de Melo, 101, São Domingos, Niteroi, RJ, CEP 24210-130, Brazil.'}, {'ForeName': 'Pedro Paulo da Silva', 'Initials': 'PPDS', 'LastName': 'Soares', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Rua Professor Hernani Pires de Melo, 101, São Domingos, Niteroi, RJ, CEP 24210-130, Brazil. ppssoares@id.uff.br.'}]",European journal of applied physiology,['10.1007/s00421-020-04441-2']
1542,32706261,"Acute mitochondrial antioxidant intake improves endothelial function, antioxidant enzyme activity, and exercise tolerance in patients with peripheral artery disease.","Peripheral artery disease (PAD) is a manifestation of atherosclerosis in the leg arteries, which causes claudication. This may be in part due to vascular mitochondrial dysfunction and excessive reactive oxygen species (ROS) production. A mitochondrial-targeted antioxidant (MitoQ) has been shown to improve vascular mitochondrial function that, in turn, led to improved vascular function in older adults and animal models. However, the roles of vascular mitochondria in vascular function including endothelial function and arterial stiffness in patients with PAD are unknown; therefore, with the use of acute MitoQ intake, this study examined the roles of vascular mitochondria in endothelial function, arterial stiffness, exercise tolerance, and skeletal muscle function in patients with PAD. Eleven patients with PAD received either MitoQ or placebo in a randomized crossover design. At each visit, blood samples, brachial and popliteal artery flow-mediated dilation (FMD), peripheral and central pulse-wave velocity (PWV), blood pressure (BP), maximal walking capacity, time to claudication (COT), and oxygen utility capacity were measured pre- and-post-MitoQ and placebo. There were significant group by time interactions ( P  < 0.05) for brachial and popliteal FMD that both increased by Δ2.6 and Δ3.3%, respectively, and increases superoxide dismutase (Δ0.03 U/mL), maximal walking time (Δ73.8 s), maximal walking distance (Δ49.3 m), and COT (Δ44.2 s). There were no changes in resting heart rate, BP, malondialdehyde, total antioxidant capacity, PWV, or oxygen utility capacity ( P  > 0.05). MitoQ intake may be an effective strategy for targeting the vascular mitochondrial environment, which may be useful for restoring endothelial function, leg pain, and walking time in patients with PAD. NEW & NOTEWORTHY  The results of this study reveal for the first time that acute oral intake of mitochondrial-targeted antioxidant (MitoQ, 80 mg) is effective for improving vascular endothelial function and superoxide dismutase in patients with peripheral artery disease (PAD). Acute MitoQ intake is also effective for improving maximal walking capacity and delaying the onset of claudication in patients with PAD. These findings suggest that the acute oral intake of MitoQ-mediated improvements in vascular mitochondria play a pivotal role for improving endothelial function, the redox environment, and skeletal muscle performance in PAD.",2020,"There were no changes in resting heart rate, BP, malondialdehyde, total antioxidant capacity, PWV, or oxygen utility capacity (p>0.05).","['peripheral artery disease patients', '11 patients with PAD received either', 'patients with PAD']","['Acute mitochondrial antioxidant intake', 'mitochondrial-targeted antioxidant (MitoQ', 'MitoQ or placebo']","['maximal walking time (Δ73.8 s), maximal walking distance', 'superoxide dismutase', 'Peripheral artery disease (PAD', 'time interactions (p<0.05) for brachial and popliteal FMD', 'resting heart rate, BP, malondialdehyde, total antioxidant capacity, PWV, or oxygen utility capacity (p>0.05', 'blood samples, brachial and popliteal artery flow-mediated dilation (FMD), peripheral and central pulse-wave velocity (PWV), blood pressure (BP), maximal walking capacity, time to claudication (COT), and oxygen utility capacity', 'endothelial function, antioxidant enzyme activity, and exercise tolerance']","[{'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}]",11.0,0.183995,"There were no changes in resting heart rate, BP, malondialdehyde, total antioxidant capacity, PWV, or oxygen utility capacity (p>0.05).","[{'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Headid', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'TeSean K', 'Initials': 'TK', 'LastName': 'Wooden', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Layec', 'Affiliation': 'Department of Kinesiology, University of Massachusetts Amherst, Amherst, Massachusetts.'}, {'ForeName': 'Santosh K', 'Initials': 'SK', 'LastName': 'Yadav', 'Affiliation': 'Department of Cellular and Integrative Physiology, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Paras K', 'Initials': 'PK', 'LastName': 'Mishra', 'Affiliation': 'Department of Cellular and Integrative Physiology, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Iraklis I', 'Initials': 'II', 'LastName': 'Pipinos', 'Affiliation': 'Department of Surgery, University of Nebraska Medical Center, Omaha, Nebraska.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00235.2020']
1543,32708831,Effect of a Single Nutritional Intervention Previous to a Critical Period of Fat Gain in University Students with Overweight and Obesity: A Randomized Controlled Trial.,"BACKGROUND


the present study aimed to investigate the effects of a single nutritional preventive session previous to a critical period linked to fat gain in university students with overweightness and obesity, emulating a nutritional session of a public health system.
METHODS


In this single-blind randomized controlled trial, 23 students met all the criteria to be included (20.91 ± 2.52-year-old; 52.2% women) who were divided into two groups: intervention group (IG) and control group (CG). Fat mass (FM) by dual-energy X-ray absorptiometry (DXA), physical activity by accelerometry, feeding evaluation through three questionnaires, and a set of healthy lifestyle recommendations were evaluated before and after the national holidays (NH).
RESULTS


Our findings showed that FM increased significantly in the CG, but not in the IG (CG = 428.1 g; IG = 321.9 g; Δ = 106.2 g;  p  = 0.654 [95% CI = -379.57, 591.92]). However, no differences were found during the NH between them (Hedges' g effect size = 0.19;  p  = 0.654). In addition, no statistical differences were observed between groups in feeding evaluations, the set of recommendations performed, and physical activity.
CONCLUSION


a single preventive session before a critical period, using a similar counselling approach as used in the public health system, might not be enough to promote changes in eating and physical activity patterns and preventing fat gain in overweight/obese university students. Long-term interventions are a must.",2020,"In addition, no statistical differences were observed between groups in feeding evaluations, the set of recommendations performed, and physical activity.
","['university students with overweightness and obesity, emulating a nutritional session of a public health system', 'University Students with Overweight and Obesity', 'overweight/obese university students', '23 students met all the criteria to be included (20.91 ± 2.52-year-old; 52.2% women']","['Single Nutritional Intervention', 'single nutritional preventive session', 'intervention group (IG) and control group (CG']","['FM', 'Fat mass (FM']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517632', 'cui_str': '2.52'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",23.0,0.0394414,"In addition, no statistical differences were observed between groups in feeding evaluations, the set of recommendations performed, and physical activity.
","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Hernández-Jaña', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, 2374631 Valparaíso, Chile.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Huber-Pérez', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, 2374631 Valparaíso, Chile.'}, {'ForeName': 'Ximena', 'Initials': 'X', 'LastName': 'Palma-Leal', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, 2374631 Valparaíso, Chile.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Guerrero-Ibacache', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, 2374631 Valparaíso, Chile.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Campos-Nuñez', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, 2374631 Valparaíso, Chile.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Zavala-Crichton', 'Affiliation': 'Faculty of Education and Social Sciences, Universidad Andres Bello, 2531015 Viña del Mar, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Jorquera-Aguilera', 'Affiliation': 'School of Nutrition and Dietetics, Faculty of Science, Universidad Mayor, 8580000 Santiago, Chile.'}, {'ForeName': 'Kabir P', 'Initials': 'KP', 'LastName': 'Sadarangani', 'Affiliation': 'Department of Kinesiology, Universidad Autónoma de Chile, 7500912 Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rodríguez-Rodríguez', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, 2374631 Valparaíso, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cristi-Montero', 'Affiliation': 'IRyS Research Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, 2374631 Valparaíso, Chile.'}]",International journal of environmental research and public health,['10.3390/ijerph17145149']
1544,32709514,The Effects of Thrust Joint Manipulation on the Resting and Contraction Thickness of Transversus Abdominis in Patients With Low Back Pain: A Randomized Control Trial.,"OBJECTIVE


To investigate the immediate changes in resting and contracted thickness of the transversus abdominis (TrA) muscle after application of thrust joint manipulation (TJM) vs sham manipulation in participants with low back pain.
METHODS


A pretest-posttest randomized controlled trial design was performed. Consecutive subjects satisfying eligibility criteria completed patient-report outcome baseline measures, pretreatment rehabilitative ultrasound imaging (RUSI) measurements, followed by the randomly assigned intervention then, post-treatment RUSI measurements, and post-treatment & final patient-reported outcome measures. To compare the outcomes of TJM and sham manipulation on the TrA muscle thickness, a 2-by-2 analysis of variance (treatment [TJM and sham manipulation]) by time (pretreatment and post-treatment) was completed for both the TrA muscle thickness at rest and muscle thickness during contraction. Descriptive statistics including independent-sample t tests for continuous variables and χ 2  tests for categorical variables were used to analyze differences in patient-reported outcome measures between groups.
RESULTS


Sixty-seven eligible participants agreed to participate. No significant interactions were identified for either muscle thickness at rest or contraction.
CONCLUSION


This study did not support the hypothesis that manipulation would result in greater changes in TrA thickness at rest or during contraction in participants with low back pain. Based on prior research that identified subgroups of participants likely to respond to manipulation, future research should include participants more likely to respond favorably to TJM. This study was a priori registered with clinicaltrails.gov (NCT02558855).",2020,"No significant interactions were identified for either muscle thickness at rest or contraction.
","['participants with low back pain', 'Patients With Low Back Pain', 'Sixty-seven eligible participants agreed to participate']","['TJM and sham manipulation', 'transversus abdominis (TrA) muscle after application of thrust joint manipulation (TJM) vs sham manipulation', 'Thrust Joint Manipulation']",['TrA thickness'],"[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517852', 'cui_str': '67'}]","[{'cui': 'C0556783', 'cui_str': 'Manipulation of joint - non-surgical'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}]",67.0,0.123283,"No significant interactions were identified for either muscle thickness at rest or contraction.
","[{'ForeName': 'Kelly K', 'Initials': 'KK', 'LastName': 'Fosberg', 'Affiliation': 'Nova Southeastern University, Fort Lauderdale, FL; DeRosa Physical Therapy, Flagstaff, AZ. Electronic address: fosbergk@summitctr.net.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Puentedura', 'Affiliation': 'School of Allied Health Sciences Department, University of Las Vegas Nevada, Las Vegas, NV.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Schmitz', 'Affiliation': 'DeRosa Physical Therapy, Flagstaff, AZ.'}, {'ForeName': 'Tarang K', 'Initials': 'TK', 'LastName': 'Jain', 'Affiliation': 'Department of Physical Therapy, Northern Arizona University, Flagstaff, AZ.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': 'Franklin Pierce University, Manchester, NH.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.04.006']
1545,32717180,"Second-look surgery plus hyperthermic intraperitoneal chemotherapy versus surveillance in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15): a randomised, phase 3 study.","BACKGROUND


Diagnosis and treatment of colorectal peritoneal metastases at an early stage, before the onset of signs, could improve patient survival. We aimed to compare the survival benefit of systematic second-look surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC), with surveillance, in patients at high risk of developing colorectal peritoneal metastases.
METHODS


We did an open-label, randomised, phase 3 study in 23 hospitals in France. Eligible patients were aged 18-70 years and had a primary colorectal cancer with synchronous and localised colorectal peritoneal metastases removed during tumour resection, resected ovarian metastases, or a perforated tumour. Patients were randomly assigned (1:1) to surveillance or second-look surgery plus oxaliplatin-HIPEC (oxaliplatin 460 mg/m 2 , or oxaliplatin 300 mg/m 2  plus irinotecan 200 mg/m 2 , plus intravenous fluorouracil 400 mg/m 2 ), or mitomycin-HIPEC (mitomycin 35 mg/m 2 ) alone in case of neuropathy, after 6 months of adjuvant systemic chemotherapy with no signs of disease recurrence. Randomisation was done via a web-based system, with stratification by treatment centre, nodal status, and risk factors for colorectal peritoneal metastases. Second-look surgery consisted of a complete exploration of the abdominal cavity via xyphopubic incision, and resection of all peritoneal implants if resectable. Surveillance after resection of colorectal cancer was done according to the French Guidelines. The primary outcome was 3-year disease-free survival, defined as the time from randomisation to peritoneal or distant disease recurrence, or death from any cause, whichever occurred first, analysed by intention to treat. Surgical complications were assessed in the second-look surgery group only. This study was registered at ClinicalTrials.gov, NCT01226394.
FINDINGS


Between June 11, 2010, and March 31, 2015, 150 patients were recruited and randomly assigned to a treatment group (75 per group). After a median follow-up of 50·8 months (IQR 47·0-54·8), 3-year disease-free survival was 53% (95% CI 41-64) in the surveillance group versus 44% (33-56) in the second-look surgery group (hazard ratio 0·97, 95% CI 0·61-1·56). No treatment-related deaths were reported. 29 (41%) of 71 patients in the second-look surgery group had grade 3-4 complications. The most common grade 3-4 complications were intra-abdominal adverse events (haemorrhage, digestive leakage) in 12 (23%) of 71 patients and haematological adverse events in 13 (18%) of 71 patients.
INTERPRETATION


Systematic second-look surgery plus oxaliplatin-HIPEC did not improve disease-free survival compared with standard surveillance. Currently, essential surveillance of patients at high risk of developing colorectal peritoneal metastases appears to be adequate and effective in terms of survival outcomes.
FUNDING


French National Cancer Institute.",2020,"INTERPRETATION


Systematic second-look surgery plus oxaliplatin-HIPEC did not improve disease-free survival compared with standard surveillance.","['Between June 11, 2010, and March 31, 2015, 150 patients', 'Eligible patients were aged 18-70 years and had a primary colorectal cancer with synchronous and localised colorectal peritoneal metastases removed during tumour resection, resected ovarian metastases, or a perforated tumour', 'patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15', 'patients at high risk of developing colorectal peritoneal metastases', '23 hospitals in France']","['oxaliplatin-HIPEC', 'surveillance or second-look surgery plus oxaliplatin-HIPEC (oxaliplatin 460 mg/m 2 , or oxaliplatin 300 mg/m 2  plus irinotecan 200 mg/m 2 , plus intravenous fluorouracil 400 mg/m 2 ), or mitomycin-HIPEC (mitomycin 35 mg/m 2 ) alone in case of neuropathy, after 6 months of adjuvant systemic chemotherapy', 'Second-look surgery plus hyperthermic intraperitoneal chemotherapy', 'systematic second-look surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC']","['grade 3-4 complications', '3-year disease-free survival, defined as the time from randomisation to peritoneal or distant disease recurrence, or death from any cause, whichever occurred first, analysed by intention to treat', 'intra-abdominal adverse events (haemorrhage, digestive leakage', '3-year disease-free survival', 'disease-free survival', 'haematological adverse events', 'Surgical complications']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant neoplasm of peritoneum'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0022790', 'cui_str': 'Krukenberg tumor'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0949626', 'cui_str': 'Incision and reexploration for second look'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",150.0,0.506933,"INTERPRETATION


Systematic second-look surgery plus oxaliplatin-HIPEC did not improve disease-free survival compared with standard surveillance.","[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Goéré', 'Affiliation': 'Department of Surgical Oncology, University Hospital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France; Department of Surgical Oncology, University Hospital Gustave Roussy, Villejuif, France. Electronic address: diane.goere@aphp.fr.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Glehen', 'Affiliation': 'Department of Surgical Oncology, University Hospital Lyon Sud, Pierre Bénite, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Quenet', 'Affiliation': 'Department of Surgical Oncology, Institut Régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Guilloit', 'Affiliation': 'Department of Surgical Oncology, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Bereder', 'Affiliation': 'Department of Surgical Oncology, University Hospital de Larchet, Nice, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Lorimier', 'Affiliation': 'Department of Surgical Oncology, Centre Paul Papin, Angers, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Thibaudeau', 'Affiliation': ""Department of Surgical Oncology, Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Ghouti', 'Affiliation': 'Department of Surgical Oncology, University Hospital Purpan, Toulouse, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Pinto', 'Affiliation': 'Department of Surgical Oncology, University Hospital Purpan, Toulouse, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Department of Surgical Oncology, University Hospital Charles Nicolle, Rouen, France.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Kianmanesh', 'Affiliation': 'Department of Surgical Oncology, University Hospital Robert Debré, Reims, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Carretier', 'Affiliation': 'Department of Surgical Oncology, University Hospital de Poitiers, Poitiers, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Marchal', 'Affiliation': 'Department of Surgical Oncology, Institut de Cancérologie de Lorraine, Nancy, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arvieux', 'Affiliation': 'Department of Visceral Surgery, University Hospital, Grenoble, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Brigand', 'Affiliation': 'Department of Surgical Oncology, University Hospital Hautepierre, Strasbourg, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Meeus', 'Affiliation': 'Department of Surgical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rat', 'Affiliation': 'Department of Surgical Oncology, University Hospital du Bocage, Dijon, France.'}, {'ForeName': 'Sylvaine', 'Initials': 'S', 'LastName': 'Durand-Fontanier', 'Affiliation': 'Department of Surgical Oncology, University Hospital Dupuytren, Limoges, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Mariani', 'Affiliation': 'Department of Surgical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Zaher', 'Initials': 'Z', 'LastName': 'Lakkis', 'Affiliation': 'Department of Surgical Oncology, University Hospital Jean Minjoz, Besançon, France.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Loi', 'Affiliation': 'Department of Surgical Oncology, University Hospital Tenon, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Pirro', 'Affiliation': 'Department of Surgical Oncology, University Hospital La Timone, Marseille, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Sabbagh', 'Affiliation': 'Department of Surgical Oncology, University Hospital Amiens-Picardie, Amiens, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Texier', 'Affiliation': 'Department of Biostatistics, University Hospital Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Elias', 'Affiliation': 'Department of Surgical Oncology, University Hospital Gustave Roussy, Villejuif, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30322-3']
1546,32718724,Effects of dobutamine and phenylephrine on cerebral perfusion in patients undergoing cerebral bypass surgery: a randomised crossover trial.,"BACKGROUND


Patients undergoing cerebral bypass surgery are prone to cerebral hypoperfusion. Currently, arterial blood pressure is often increased with vasopressors to prevent cerebral ischaemia. However, this might cause vasoconstriction of the graft and cerebral vasculature and decrease perfusion. We hypothesised that cardiac output, rather than arterial blood pressure, is essential for adequate perfusion and aimed to determine whether dobutamine administration resulted in greater graft perfusion than phenylephrine administration.
METHODS


This randomised crossover study included 10 adult patients undergoing cerebral bypass surgery. Intraoperatively, patients randomly and sequentially received dobutamine to increase cardiac index or phenylephrine to increase mean arterial pressure (MAP). An increase of >10% in cardiac index or >10% in MAP was targeted, respectively. Before both interventions, a reference phase was implemented. The primary outcome was the absolute difference in graft flow between the reference and intervention phase. We compared the absolute flow difference between each intervention and constructed a random-effect linear regression model to explore treatment and carry-over effects.
RESULTS


Graft flow increased with a median of 4.1 (inter-quartile range [IQR], 1.7-12.0] ml min -1 ) after dobutamine administration and 3.6 [IQR, 1.3-7.8] ml min -1  after phenylephrine administration (difference -0.6 ml min -1 ; 95% confidence interval [CI], -14.5 to 5.3; P=0.441). There was no treatment effect (0.9 ml min -1 ; 95% CI, 0.0-20.1; P=0.944) and no carry-over effect.
CONCLUSIONS


Both dobutamine and phenylephrine increased graft flow during cerebral bypass surgery, without a preference for one method over the other.
CLINICAL TRIAL REGISTRATION


Netherlands Trial Register, NL7077 (https://www.trialregister.nl/trial/7077).",2020,"There was no treatment effect (0.9 ml min -1 ; 95% CI, 0.0-20.1; P=0.944) and no carry-over effect.
","['Patients undergoing', '10 adult patients undergoing cerebral bypass surgery', 'patients undergoing cerebral bypass surgery']","['cerebral bypass surgery', 'phenylephrine', 'dobutamine', 'dobutamine and phenylephrine']","['mean arterial pressure (MAP', 'graft perfusion', 'arterial blood pressure', 'graft flow', 'cerebral perfusion', 'Graft flow', 'absolute difference in graft flow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0012963', 'cui_str': 'Dobutamine'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",10.0,0.476268,"There was no treatment effect (0.9 ml min -1 ; 95% CI, 0.0-20.1; P=0.944) and no carry-over effect.
","[{'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Akkermans', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: a.akkermans@umcutrecht.nl.'}, {'ForeName': 'Judith A R', 'Initials': 'JAR', 'LastName': 'van Waes', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Tristan P C', 'Initials': 'TPC', 'LastName': 'van Doormaal', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Neurosurgery, University Hospital Zürich, Zurich, Switzerland.'}, {'ForeName': 'Eric E C', 'Initials': 'EEC', 'LastName': 'de Waal', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Gabriël J E', 'Initials': 'GJE', 'LastName': 'Rinkel', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'van der Zwan', 'Affiliation': 'Department of Neurology and Neurosurgery, Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Cor J', 'Initials': 'CJ', 'LastName': 'Kalkman', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Wilton A', 'Initials': 'WA', 'LastName': 'van Klei', 'Affiliation': 'Department of Anaesthesiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.040']
1547,32718783,Effect of a Peer-led Lifestyle Intervention on Individuals With Normal Weight Obesity: Insights From the Kerala Diabetes Prevention Program.,"PURPOSE


Normal weight obesity (NWO) is a unique phenotype of obesity associated with high cardiovascular mortality. There is limited literature on assessing the effect of therapeutic interventions on the cardiometabolic health of these individuals. We studied the effect of a peer-led lifestyle intervention on key cardiometabolic parameters (blood glucose, blood pressure, and plasma lipids) in individuals with NWO.
METHODS


This study is a secondary data analysis of the Kerala Diabetes Prevention Program, a cluster-randomized controlled study that involves a peer-led, real-life lifestyle intervention for individuals from the community between the ages of 30 and 60 years with a high diabetes risk. Participants underwent a rigorous cardiometabolic evaluation at baseline and at 2-year follow-up.
FINDINGS


A total of 292 recruited individuals with NWO were randomized into the intervention (n = 159) and control (n = 133) arms. At 2 years of follow-up, there was minimal but statistically significant improvement in systolic blood pressure and serum HDL level in the intervention arm, but no statistical difference was seen in other lipid and glycemic parameters.
IMPLICATIONS


This study provides early evidence of the effect of a lifestyle intervention in a cohort of individuals with NWO. Only systolic blood pressure and serum HDL level had a mild favorable change in the intervention arm when compared with the control arm.",2020,Only systolic blood pressure and serum HDL level had a mild favorable change in the intervention arm when compared with the control arm.,"['cohort of individuals with NWO', 'A total of 292 recruited individuals with NWO', 'Individuals With Normal Weight Obesity', 'individuals with NWO', 'individuals from the community between the ages of 30 and 60 years with a high diabetes risk']","['Peer-led Lifestyle Intervention', 'lifestyle intervention', 'peer-led, real-life lifestyle intervention', 'peer-led lifestyle intervention']","['cardiometabolic parameters (blood glucose, blood pressure, and plasma lipids', 'systolic blood pressure and serum HDL level', 'lipid and glycemic parameters']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",292.0,0.0298572,Only systolic blood pressure and serum HDL level had a mild favorable change in the intervention arm when compared with the control arm.,"[{'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Kapoor', 'Affiliation': 'Department of Endocrinology, Diabetes, and Metabolism, Christian Medical College & Hospital, Vellore, Tamil Nadu, India; Melbourne School of Population and Global Health, Faculty of Medicine, Dentistry, and Health Science, The University of Melbourne, Melbourne, Australia. Electronic address: nitin.kapoor@cmcvellore.ac.in.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Lotfaliany', 'Affiliation': 'Melbourne School of Population and Global Health, Faculty of Medicine, Dentistry, and Health Science, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Thirunavukkarasu', 'Initials': 'T', 'LastName': 'Sathish', 'Affiliation': 'Melbourne School of Population and Global Health, Faculty of Medicine, Dentistry, and Health Science, The University of Melbourne, Melbourne, Australia; Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore.'}, {'ForeName': 'Kavumpurathu R', 'Initials': 'KR', 'LastName': 'Thankappan', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India; Department of Public Health and Community Medicine, Central University, Kasaragod, Kerala, India.'}, {'ForeName': 'Robyn J', 'Initials': 'RJ', 'LastName': 'Tapp', 'Affiliation': 'Melbourne School of Population and Global Health, Faculty of Medicine, Dentistry, and Health Science, The University of Melbourne, Melbourne, Australia; The School of Biomedical Engineering and Imaging Sciences, Kings College London, London, United Kingdom; Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, United Kingdom.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'Department of Endocrinology, Diabetes, and Metabolism, Christian Medical College & Hospital, Vellore, Tamil Nadu, India.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Furler', 'Affiliation': 'Department of General Practice, Faculty of Medicine, Dentistry and Health Science, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Melbourne School of Population and Global Health, Faculty of Medicine, Dentistry, and Health Science, The University of Melbourne, Melbourne, Australia.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.06.007']
1548,32723843,Use of Factory-Calibrated Real-time Continuous Glucose Monitoring Improves Time in Target and HbA 1c  in a Multiethnic Cohort of Adolescents and Young Adults With Type 1 Diabetes: The MILLENNIALS Study.,"OBJECTIVE


International type 1 diabetes registries have shown that HbA 1c  levels are highest in young people with type 1 diabetes; however, improving their glycemic control remains a challenge. We propose that use of the factory-calibrated Dexcom G6 CGM system would improve glycemic control in this cohort.
RESEARCH DESIGN AND METHODS


We conducted a randomized crossover trial in young people with type 1 diabetes (16-24 years old) comparing the Dexcom G6 CGM system and self-monitoring of blood glucose (SMBG). Participants were assigned to the interventions in random order during two 8-week study periods. During SMBG, blinded continuous glucose monitoring (CGM) was worn by each participant for 10 days at the start, week 4, and week 7 of the control period. HbA 1c  measurements were drawn after enrollment and before and after each treatment period. The primary outcome was time in range 70-180 mg/dL.
RESULTS


Time in range was significantly higher during CGM compared with control (35.7 ± 13.5% vs. 24.6 ± 9.3%; mean difference 11.1% [95% CI 7.0-15.2];  P  < 0.001). CGM use reduced mean sensor glucose (219.7 ± 37.6 mg/dL vs. 251.9 ± 36.3 mg/dL; mean difference -32.2 mg/dL [95% CI -44.5 to -20.0];  P  < 0.001) and time above range (61.7 ± 15.1% vs. 73.6 ± 10.4%; mean difference 11.9% [95% CI -16.4 to -7.4];  P  < 0.001). HbA 1c  level was reduced by 0.76% (95% CI -1.1 to -0.4) (-8.5 mmol/mol [95% CI -12.4 to -4.6];  P  < 0.001). Times spent below range (<70 mg/dL and <54 mg/dL) were low and comparable during both study periods. Sensor wear was 84% during the CGM period.
CONCLUSIONS


CGM use in young people with type 1 diabetes improves time in target and HbA 1c  levels compared with SMBG.",2020,mean difference 11.1% [95% CI 7.0-15.2];  P  < 0.001).,"['young people with type 1 diabetes (16-24 years old', 'Multiethnic Cohort of Adolescents and Young Adults With Type 1 Diabetes', 'young people with type 1 diabetes']","['Factory-Calibrated Real-time Continuous Glucose Monitoring', 'CGM', 'Dexcom G6 CGM system and self-monitoring of blood glucose (SMBG', 'factory-calibrated Dexcom G6 CGM system', 'dL']","['mean sensor glucose', 'glycemic control', 'time in range 70-180 mg/dL.\nRESULTS\n\n\nTime in range', 'HbA 1c  level']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0442614', 'cui_str': 'Factory'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.046691,mean difference 11.1% [95% CI 7.0-15.2];  P  < 0.001).,"[{'ForeName': 'Hood', 'Initials': 'H', 'LastName': 'Thabit', 'Affiliation': 'Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester, U.K. hood.thabit@mft.nhs.uk.'}, {'ForeName': 'Joshi Navis', 'Initials': 'JN', 'LastName': 'Prabhu', 'Affiliation': 'Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester, U.K.'}, {'ForeName': 'Womba', 'Initials': 'W', 'LastName': 'Mubita', 'Affiliation': 'Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester, U.K.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fullwood', 'Affiliation': 'Research and Innovation, Manchester Royal Infirmary, Manchester, U.K.'}, {'ForeName': 'Shazli', 'Initials': 'S', 'LastName': 'Azmi', 'Affiliation': 'Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester, U.K.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Urwin', 'Affiliation': 'Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester, U.K.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Doughty', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester Royal Infirmary, Manchester, U.K.""}, {'ForeName': 'Lalantha', 'Initials': 'L', 'LastName': 'Leelarathna', 'Affiliation': 'Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester, U.K.'}]",Diabetes care,['10.2337/dc20-0736']
1549,32726364,Four weeks of augmented eccentric loading using a novel leg press device improved leg strength in well-trained athletes and professional sprint track cyclists.,"This study assessed the efficacy of strength training using augmented eccentric loading to provoke increases in leg strength in well-trained athletes, and sprint track cyclists, using a novel leg press device. Twelve well-trained athletes were randomly allocated traditional resistance training (TRAD, n = 6), or resistance training using augmented eccentric loading (AEL, n = 6). A further 5 full-time, professional sprint track cyclists from a senior national squad programme also trained with augmented eccentric loading (AEL-ATH) alongside their usual sport-specific training. Participants completed four weeks of twice-weekly resistance training using the leg press exercise. In TRAD the lowering phase of the lift was set relative to concentric strength. In AEL and AEL-ATH the lowering phase was individualised to eccentric strength. Concentric, eccentric, isometric and coupled eccentric-concentric leg press strength, and back squat 1 repetition maximum (1RM), were assessed pre- and post-training. The AEL and AEL-ATH groups performed the eccentric phase with an average 26 ± 4% greater load across the programme. All groups experienced increases in concentric (5%, 7% and 3% for TRAD, AEL & AEL-ATH respectively), eccentric (7%, 11% and 6% for TRAD, AEL & AEL-ATH respectively), and squat 1RM (all p < 0.05), where the AEL-ATH group experienced relatively greater increases (13% vs. 5% in TRAD and AEL, p < 0.01). The TRAD and AEL groups also increased isometric strength (p < 0.05). A four-week period of augmented eccentric loading increased leg strength in well-trained athletes and track cyclists. The eccentric leg press stimulus was well-tolerated, supporting the inclusion of such training in the preparation programmes of athletes.",2020,"All groups experienced increases in concentric (5%, 7% and 3% for TRAD, AEL & AEL-ATH respectively), eccentric (7%, 11% and 6% for TRAD, AEL & AEL-ATH respectively), and squat 1RM (all p < 0.05), where the AEL-ATH group experienced relatively greater increases (13% vs. 5% in TRAD and AEL, p < 0.01).","['Twelve well-trained athletes', 'well-trained athletes and track cyclists', 'well-trained athletes and professional sprint track cyclists']","['strength training', 'augmented eccentric loading', 'resistance training using the leg press exercise', 'traditional resistance training (TRAD, n = 6), or resistance training using augmented eccentric loading (AEL, n = 6']","['concentric', 'Concentric, eccentric, isometric and coupled eccentric-concentric leg press strength, and back squat 1 repetition maximum (1RM', 'leg strength', 'squat 1RM', 'isometric strength']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0040594', 'cui_str': 'Track'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0023440', 'cui_str': 'Acute myeloid leukemia, M6 type'}]","[{'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0141622,"All groups experienced increases in concentric (5%, 7% and 3% for TRAD, AEL & AEL-ATH respectively), eccentric (7%, 11% and 6% for TRAD, AEL & AEL-ATH respectively), and squat 1RM (all p < 0.05), where the AEL-ATH group experienced relatively greater increases (13% vs. 5% in TRAD and AEL, p < 0.01).","[{'ForeName': 'Mellissa', 'Initials': 'M', 'LastName': 'Harden', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'English Institute of Sport, Manchester, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The Football Association, Burton on Trent, United Kingdom.'}, {'ForeName': 'Kirsty Marie', 'Initials': 'KM', 'LastName': 'Hicks', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, United Kingdom.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0236663']
1550,32728226,"A randomised, prospective study of 'off-the-shelf' use of toric intraocular lenses for cataract patients with pre-existing corneal astigmatism in the NHS.","BACKGROUND/OBJECTIVES


To compare visual and refractive outcomes of monofocal intraocular lenses (IOLs) with limbal relaxing incisions (LRI) with 'off-the-shelf' use of toric IOLs (TIOLs), with a fixed 2-dioptre cylinder (DC) correction, for cataract patients with pre-existing corneal astigmatism in a public-sector setting.
SUBJECTS/METHODS


Seventy-seven patients (77 eyes, first treated eye) with visually significant cataract and pre-operative corneal astigmatism ≥2.00 DC were randomised to receive either 'off-the-shelf' TIOLs, with a fixed 2.00 DC cylinder correction (39 eyes), or monofocal IOLs (38 eyes) with LRIs. The concept of fixing the cylindrical correction was to minimise costs, allow a full TIOL bank to be available and eliminate the need for individual TIOL ordering. Outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) and refraction. Astigmatic changes were evaluated using the Alpins vector method.
RESULTS


Mean UDVA improved from logMAR 0.88 (SD 0.56)[~20/150] pre-operatively to 0.18 (SD 0.19)[~20/30] post-operatively in TIOL group, versus 0.82 (SD 0.55)[~20/130] to 0.27 (SD 0.15)[~20/40] in monofocal/LRI group (P = 0.02; 95% CI: -0.17, -0.01). Mean CDVA improved from logMAR 0.40 (SD 0.26)[~20/50] to 0.01 (SD 0.12)[~20/20] in TIOL group, and 0.41 (SD 0.38)[~20/40] to 0.06 (SD 0.12)[~20/25] in LRI group (P = 0.07; 95% CI: -0.11, 0.01). Average post-operative refractive cylinder in TIOL group was 1.35 DC (SD 0.84 DC) and in LRI group 1.91 DC (SD 1.07 DC) (P = 0.01; 95% CI: -1, -0.12). Mean difference vector magnitude was 1.92 DC (SD 1.08 DC) in LRI group and 1.37 DC (SD 0.84 DC) in TIOL group (P = 0.02; 95% CI: 0.11, 0.99).
CONCLUSIONS


TIOLs with a fixed 2.00 DC correction during cataract surgery may improve UDVA, reduce post-operative cylinder and result in a more reliable astigmatic correction compared with monofocal IOLs with LRIs.",2020,"RESULTS


Mean UDVA improved from logMAR 0.88 (SD 0.56)[~20/150] pre-operatively to 0.18","['Seventy-seven patients (77 eyes, first treated eye) with visually significant cataract and pre-operative corneal astigmatism', 'cataract patients with pre-existing corneal astigmatism in the NHS', 'cataract patients with pre-existing corneal astigmatism in a public-sector setting']","['fixed 2.00 DC cylinder correction (39 eyes), or monofocal IOLs (38 eyes) with LRIs', 'monofocal intraocular lenses (IOLs) with limbal relaxing incisions (LRI', 'toric IOLs (TIOLs), with a fixed 2-dioptre cylinder (DC) correction', 'toric intraocular lenses']","['Mean difference vector magnitude', 'uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) and refraction', 'Mean CDVA', 'Mean UDVA']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0443251', 'cui_str': 'Limbal'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}]",,0.196616,"RESULTS


Mean UDVA improved from logMAR 0.88 (SD 0.56)[~20/150] pre-operatively to 0.18","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Stanojcic', 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK. nstanojcic@doctors.org.uk.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Roberts', 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK.""}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Wagh', 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Zuberbuhler', 'Affiliation': 'Zubimed Augenzentrum, Niederhasli, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Brart"", 'Affiliation': ""Department of Ophthalmology, King's College London Frost Eye Research Unit, Guy's and St Thomas' NHS Foundation Trust, Lambeth Palace Road, London, SE1 7EH, UK.""}]","Eye (London, England)",['10.1038/s41433-020-0919-8']
1551,32747544,An objective evaluation of the beholder's response to abstract and figurative art based on construal level theory.,"Does abstract art evoke a different cognitive state than figurative art? To address this question empirically, we bridged art theory and cognitive research and designed an experiment leveraging construal level theory (CLT). CLT is based on experimental data showing that psychologically distant events (i.e., occurring farther away in space or time) are represented more abstractly than closer events. We measured construal level elicited by abstract vs. representational art and asked subjects to assign abstract/representational paintings by the same artist to a situation that was temporally/spatially near or distant. Across three experiments, we found that abstract paintings were assigned to the distant situation significantly more often than representational paintings, indicating that abstract art was evocative of greater psychological distance. Our data demonstrate that different levels of artistic abstraction evoke different levels of mental abstraction and suggest that CLT provides an empirical approach to the analysis of cognitive states evoked by different levels of artistic abstraction.",2020,"Across three experiments, we found that abstract paintings were assigned to the distant situation significantly more often than representational paintings, indicating that abstract art was evocative of greater psychological distance.",[],['CLT'],[],[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}]",[],,0.0375673,"Across three experiments, we found that abstract paintings were assigned to the distant situation significantly more often than representational paintings, indicating that abstract art was evocative of greater psychological distance.","[{'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Durkin', 'Affiliation': 'Department of Psychology, Columbia University, New York, NY 10027.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Hartnett', 'Affiliation': 'Department of Psychology, Columbia University, New York, NY 10027.'}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Shohamy', 'Affiliation': 'Department of Psychology, Columbia University, New York, NY 10027; ds2619@columbia.edu erk5@columbia.edu.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Kandel', 'Affiliation': 'Mortimer B. Zuckerman Mind Brain Behavior Institute, Columbia University, New York, NY 10027; ds2619@columbia.edu erk5@columbia.edu.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2001772117']
1552,32748404,A cost-effective approach to increasing participation in patient-reported outcomes research in cancer: A randomized trial of video invitations.,"Maximizing participation in cancer research is important to improve the validity and generalizability of research findings. We conducted a four-arm randomized controlled trial to test the impact of a novel video invitation on participant response. We invited childhood cancer survivors and parents of survivors <16 years to complete questionnaires. We compared response rates to an invitation letter (control) vs receiving the letter plus a video invitation on a flash drive presented by a childhood cancer survivor, a pediatric oncologist or a researcher. We explored factors associated with viewing the video and examined the impact of enclosing the USB on study costs. Overall 54% (634/1176) of questionnaires were returned. Participants who received a video invitation on a USB were more likely to return the questionnaire than those who did not (58% vs 47%, P < .001). Participation rate did not significantly differ by video presenter. Forty-seven percent of participants who received a USB reported watching the video, of whom 48% reported that the video influenced their decision to participate. Participants with a lower income (OR = 0.43, 95% CI = 0.25-0.74, P = .002) were more likely to report watching the video. Participants who received a video invitation required significantly fewer reminder calls than those who only received a written invitation (mean = 1.6 vs 1.1 calls, P < .001), resulting in a 25% recruitment cost-saving for the study. Adding a USB with a video study invitation to recruitment packages is a cost-effective way of improving study participation. This is important in an era of declining study participation and underrepresentation of vulnerable populations in research.",2020,"Participants who received a video invitation required significantly fewer reminder calls than those who only received a written invitation (mean = 1.6 vs 1.1 calls, P < 0.001), resulting in a 25% recruitment cost-saving for the study.","['Participants with a lower income (OR\xa0=\xa00.43, 95%CI\xa0', 'childhood cancer survivors and parents of survivors <16\u2009years to complete questionnaires', 'cancer']","['invitation letter (control) vs receiving the letter plus a video invitation', 'novel video invitation', 'video invitations', 'video invitation']","['Participation rate', 'reminder calls']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4505050', 'cui_str': 'Survivors of Childhood Cancer'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C1720420', 'cui_str': 'Call'}]",,0.0575472,"Participants who received a video invitation required significantly fewer reminder calls than those who only received a written invitation (mean = 1.6 vs 1.1 calls, P < 0.001), resulting in a 25% recruitment cost-saving for the study.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Signorelli', 'Affiliation': ""Kids Cancer Centre, Sydney Children's Hospital, Randwick, New South Wales, Australia.""}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wakefield', 'Affiliation': ""Kids Cancer Centre, Sydney Children's Hospital, Randwick, New South Wales, Australia.""}, {'ForeName': 'Jordana K', 'Initials': 'JK', 'LastName': 'McLoone', 'Affiliation': ""Kids Cancer Centre, Sydney Children's Hospital, Randwick, New South Wales, Australia.""}, {'ForeName': 'Marion K', 'Initials': 'MK', 'LastName': 'Mateos', 'Affiliation': ""Kids Cancer Centre, Sydney Children's Hospital, Randwick, New South Wales, Australia.""}, {'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Aaronson', 'Affiliation': 'Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Ange', 'Initials': 'A', 'LastName': 'Lavoipierre', 'Affiliation': ""Kids Cancer Centre, Sydney Children's Hospital, Randwick, New South Wales, Australia.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Cohn', 'Affiliation': ""Kids Cancer Centre, Sydney Children's Hospital, Randwick, New South Wales, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of cancer,['10.1002/ijc.33244']
1553,32748765,Increased hand hygiene compliance in nursing homes after a multimodal intervention: A cluster randomized controlled trial (HANDSOME).,"OBJECTIVE


To assess the effect of a multimodal intervention on hand hygiene compliance (HHC) in nursing homes.
DESIGN, SETTING, AND PARTICIPANTS


HHC was evaluated using direct, unobtrusive observation in a cluster randomized controlled trial at publicly funded nursing homes in the Netherlands. In total, 103 nursing home organizations were invited to participate; 18 organizations comprising 33 nursing homes (n = 66 nursing home units) participated in the study. Nursing homes were randomized into a control group (no intervention, n = 30) or an intervention group (multimodal intervention, n = 36). The primary outcome measure was HHC of nurses. HHC was appraised at baseline and at 4, 7, and 12 months after baseline. Observers and nurses were blinded.
INTERVENTION


Audits regarding hand hygiene (HH) materials and personal hygiene rules, 3 live lessons, an e-learning program, posters, and a photo contest. We used a new method to teach the nurses the WHO-defined 5 moments of HH: Room In, Room Out, Before Clean, and After Dirty.
RESULTS


HHC increased in both arms. The increase after 12 months was larger for units in the intervention arm (from 12% to 36%) than for control units (from 13% to 21%) (odds ratio [OR], 2.10; confidence interval [CI], 1.35-3.28). The intervention arm exhibited a statistically significant increase in HHC at 4 of the 5 WHO-defined HH moments. At follow-up, HHC in the intervention arm remained statistically significantly higher (OR, 1.93; 95% CI, 1.59-2.34) for indications after an activity (from 37% to 39%) than for indications before an activity (from 14% to 27%).
CONCLUSIONS


The HANDSOME intervention is successful in improving HHC in nursing homes.",2020,"The increase after 12 months was larger for units in the intervention arm (from 12% to 36%) than for control units (from 13% to 21%) (odds ratio [OR], 2.10; confidence interval [CI], 1.35-3.28).","['Nursing homes', 'nursing homes', 'nurses the WHO-defined 5 moments of HH', 'nursing homes after a multimodal intervention', 'publicly funded nursing homes in the Netherlands', '103 nursing home organizations were invited to participate; 18 organizations comprising 33 nursing homes (n = 66 nursing home units) participated in the study']","['control group (no intervention, n = 30) or an intervention group (multimodal intervention', 'multimodal intervention']","['hygiene compliance', 'hand hygiene compliance (HHC', 'HHC of nurses', 'HHC']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",103.0,0.110308,"The increase after 12 months was larger for units in the intervention arm (from 12% to 36%) than for control units (from 13% to 21%) (odds ratio [OR], 2.10; confidence interval [CI], 1.35-3.28).","[{'ForeName': 'Gwen R', 'Initials': 'GR', 'LastName': 'Teesing', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Erasmus', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Nieboer', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Petrignani', 'Affiliation': 'Municipal Public Health Service Haaglanden. Den Haag, The Netherlands.'}, {'ForeName': 'Marion P G', 'Initials': 'MPG', 'LastName': 'Koopmans', 'Affiliation': 'Viroscience Department, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Margreet C', 'Initials': 'MC', 'LastName': 'Vos', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Verduijn-Leenman', 'Affiliation': 'Pieter van Foreest, Delft, The Netherlands (retired).'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research and Department of Family Medicine, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Richardus', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Helene A C M', 'Initials': 'HACM', 'LastName': 'Voeten', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}]",Infection control and hospital epidemiology,['10.1017/ice.2020.319']
1554,32713104,Searching for an optimal therapy for H pylori eradication: High-dose proton-pump inhibitor dual therapy with amoxicillin vs. standard triple therapy for 14 days.,"BACKGROUND & AIMS


We compared a high-dose dual therapy (HDDT) with rabeprazole and amoxicillin and compared it with a standard triple therapy (STT) with rabeprazole, amoxicillin, and clarithromycin for 2 weeks for H pylori eradication in treatment naïve patients.
METHODS


H pylori-positive patients were randomly assigned to either a rabeparzole (Pariet) 20 mg b.i.d., amoxicillin (Ospamox) 1 g b.i.d. and clarithromycin (Klacid) 500 mg b.i.d. for 14 days or rabeprazole (Pariet) 20 mg q.i.d., amoxicillin (Ospamox) 1 g q.i.d. also for 14 days. Eradication was tested for by the C 13  -UBT at least 4 weeks after the completion of therapy.
RESULTS


H pylori was eradicated in 86.2% of patients (81/94) (95% CI: 77.8-91.7) in the STT group compared with 92.8% (90/97) (95% CI: 85.9-96.5) in the HDDT group on ITT analysis. On PP analysis, H pylori was eradicated in 91.0% of patients (81/89) (95% CI: 83.3-95.4) in the STT group compared with 93.8% (90/96) (95% CI: 87.0-97.1) in the HDDT group. Side effects were few although many patients in the STT arm complained of bitter taste. The HDDT arm was well tolerated by patients.
CONCLUSIONS


The HDDT gave a high eradication rate comparable to the STT for 2 weeks and was a well-tolerated regimen for H pylori eradication.",2020,The HDDT gave a high eradication rate comparable to the STT for 2 weeks and was a well-tolerated regimen for H pylori eradication.,"['H\xa0pylori-positive patients', 'treatment naïve patients']","['rabeparzole (Pariet', 'rabeprazole (Pariet) 20', 'rabeprazole, amoxicillin, and clarithromycin', 'clarithromycin (Klacid', 'amoxicillin vs. standard triple therapy', 'rabeprazole and amoxicillin', 'amoxicillin (Ospamox']","['Side effects', 'eradication rate', 'Eradication', 'bitter taste']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0235290', 'cui_str': 'Taste bitter'}]",,0.0469821,The HDDT gave a high eradication rate comparable to the STT for 2 weeks and was a well-tolerated regimen for H pylori eradication.,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Hwong-Ruey Leow', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jo-Ven', 'Initials': 'JV', 'LastName': 'Chang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Khean-Lee', 'Initials': 'KL', 'LastName': 'Goh', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",Helicobacter,['10.1111/hel.12723']
1555,32720870,Noninvasive Characterization of Tumor Angiogenesis and Oxygenation in Bevacizumab-treated Recurrent Glioblastoma by Using Dynamic Susceptibility MRI: Secondary Analysis of the European Organization for Research and Treatment of Cancer 26101 Trial.,"Background Relevance of antiangiogenic treatment with bevacizumab in patients with glioblastoma is controversial because progression-free survival benefit did not translate into an overall survival (OS) benefit in randomized phase III trials. Purpose To perform longitudinal characterization of intratumoral angiogenesis and oxygenation by using dynamic susceptibility contrast agent-enhanced (DSC) MRI and evaluate its potential for predicting outcome from administration of bevacizumab. Materials and Methods In this secondary analysis of the prospective randomized phase II/III European Organization for Research and Treatment of Cancer 26101 trial conducted between October 2011 and December 2015 in 596 patients with first recurrence of glioblastoma, the subset of patients with availability of anatomic MRI and DSC MRI at baseline and first follow-up was analyzed. Patients were allocated into those administered bevacizumab (hereafter, the BEV group; either bevacizumab monotherapy or bevacizumab with lomustine) and those not administered bevacizumab (hereafter, the non-BEV group with lomustine monotherapy). Contrast-enhanced tumor volume, noncontrast-enhanced T2 fluid-attenuated inversion recovery (FLAIR) signal abnormality volume, Gaussian-normalized relative cerebral blood volume (nrCBV), Gaussian-normalized relative blood flow (nrCBF), and tumor metabolic rate of oxygen (nTMRO 2 ) was quantified. The predictive ability of these imaging parameters was assessed with multivariable Cox regression and formal interaction testing. Results A total of 254 of 596 patients were evaluated (mean age, 57 years ± 11; 155 men; 161 in the BEV group and 93 in non-BEV group). Progression-free survival was longer in the BEV group (3.7 months; 95% confidence interval [CI]: 3.0, 4.2) compared with the non-BEV group (2.5 months; 95% CI: 1.5, 2.9;  P  = .01), whereas OS was not different ( P  = .15). The nrCBV decreased for the BEV group (-16.3%; interquartile range [IQR], -39.5% to 12.0%;  P  = .01), but not for the non-BEV group (1.2%; IQR, -17.9% to 23.3%;  P  = .19) between baseline and first follow-up. An identical pattern was observed for both nrCBF and nTMRO 2  values. Contrast-enhanced tumor and noncontrast-enhanced T2 FLAIR signal abnormality volumes decreased for the BEV group (-66% [IQR, -83% to -35%] and -33% [IQR, -71% to -5%], respectively;  P  < .001 for both), whereas they increased for the non-BEV group (30% [IQR, -17% to 98%],  P  = .001; and 10% [IQR, -13% to 82%],  P  = .02, respectively) between baseline and first follow-up. None of the assessed MRI parameters were predictive for OS in the BEV group. Conclusion Bevacizumab treatment decreased tumor volumes, angiogenesis, and oxygenation, thereby reflecting its effectiveness for extending progression-free survival; however, these parameters were not predictive of overall survival (OS), which highlighted the challenges of identifying patients that derive an OS benefit from bevacizumab. © RSNA, 2020  Online supplemental material is available for this article.  See also the editorial by Dillon in this issue.",2020,"Progression-free survival was longer in the BEV group (3.7 months; 95% confidence interval [CI]: 3.0, 4.2) compared with the non-BEV group (2.5 months; 95% CI: 1.5, 2.9;  P  = .01), whereas OS was not different ( P  = .15).","['A total of 254 of 596 patients were evaluated (mean age, 57 years ± 11; 155 men; 161 in the BEV group and 93 in non-BEV group', 'Cancer 26101 trial conducted between October 2011 and December 2015 in 596 patients with first recurrence of glioblastoma, the subset of patients with availability of anatomic MRI and DSC MRI at baseline and first follow-up was analyzed', 'patients with glioblastoma']","['bevacizumab monotherapy or bevacizumab with lomustine', 'bevacizumab (hereafter, the non-BEV group with lomustine monotherapy', 'bevacizumab', 'Bevacizumab']","['Contrast-enhanced tumor volume, noncontrast-enhanced T2 fluid-attenuated inversion recovery (FLAIR) signal abnormality volume, Gaussian-normalized relative cerebral blood volume (nrCBV), Gaussian-normalized relative blood flow (nrCBF), and tumor metabolic rate of oxygen (nTMRO 2 ', 'tumor volumes, angiogenesis, and oxygenation, thereby reflecting its effectiveness for extending progression-free survival', 'Contrast-enhanced tumor and noncontrast-enhanced T2 FLAIR signal abnormality volumes', 'overall survival (OS', 'Progression-free survival', 'nrCBV']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0028377', 'cui_str': 'Gaussian Distribution'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C4277714', 'cui_str': 'Cerebral Blood Volume'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",596.0,0.0767009,"Progression-free survival was longer in the BEV group (3.7 months; 95% confidence interval [CI]: 3.0, 4.2) compared with the non-BEV group (2.5 months; 95% CI: 1.5, 2.9;  P  = .01), whereas OS was not different ( P  = .15).","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kickingereder', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Brugnara', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Mikkel Bo', 'Initials': 'MB', 'LastName': 'Hansen', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Nowosielski', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Irada', 'Initials': 'I', 'LastName': 'Pflüger', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Schell', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Isensee', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Foltyn', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Neuberger', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kessler', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sahm', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Wick', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Heiland', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Platten', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'von Deimling', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Klaus H', 'Initials': 'KH', 'LastName': 'Maier-Hein', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}]",Radiology,['10.1148/radiol.2020200978']
1556,32723668,"Effects of Corrective Exercises on Posture, Pain, and Muscle Activation of Patients With Chronic Neck Pain Exposed to Anterior-Posterior Perturbation.","OBJECTIVES


This study aimed to evaluate the effects of corrective exercises on posture, pain, and muscle activation of patients with chronic neck pain exposed to anterior-posterior perturbation.
METHODS


A total of 32 women (37.76 ± 3.83 years) with chronic, nonspecific neck pain were randomized into corrective exercise and control groups. The experimental group underwent a corrective exercise program for 8 weeks, 30 min/d, 3 days per week. The control group received active self-exercise instructions. Neck pain, forward head and protracted shoulder posture, and timing of superficial neck muscle activation were evaluated using the visual analog scale, photogrammetry, and electromyogram, respectively, before and then 48 hours after the 8-week program for both the experimental and control groups. All measurements at pretest and posttest were taken by a blinded assessor.
RESULTS


Significant alterations were observed in cervical angle (P = .003, effect size = 0.329), shoulder angle (P = .008, effect size = 0.457), neck pain and disability (P = .009, effect size = 0.645), movement control (P = .038, effect size = 0.353), activation onset of the upper trapezius (P = .015, effect size = 0.746), the sternocleidomastoid (P = .018, effect size = 0.879) and cervical erector spinae (P = .031, effect size = 0.765), and the root mean square of the upper trapezius (P = .033, effect size = 0.742), the sternocleidomastoid (P = .041, effect size = 0.587), and the cervical erector spinae (P = .024, effect size = 0.832) in the intervention group from pre- to posttest (P < .05).
CONCLUSION


Positive and significant alterations have been observed in the forward head and protracted shoulder posture, the timing of superficial neck muscle activation, neck pain, and disability in female patients with chronic neck pain exposed to anterior-posterior perturbation after performing an 8-week corrective exercise program.",2020,"RESULTS


Significant alterations were observed in cervical angle (P = .003, effect size = 0.329), shoulder angle (P = .008, effect size = 0.457), neck pain and disability (P = .009, effect size = 0.645), movement control (P ","['patients with chronic neck pain exposed to anterior-posterior perturbation', 'Patients', 'female patients with chronic neck pain', '32 women (37.76 ± 3.83 years) with chronic, nonspecific neck pain']","['active self-exercise instructions', 'Corrective Exercises', 'corrective exercise', 'corrective exercises', 'corrective exercise program']","['activation onset of the upper trapezius', 'Posture, Pain, and Muscle Activation', 'cervical erector spinae ', 'root mean square of the upper trapezius', 'Neck pain, forward head and protracted shoulder posture, and timing of superficial neck muscle activation', 'shoulder angle', 'cervical erector spinae', 'cervical angle', 'posture, pain, and muscle activation', 'neck pain and disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",32.0,0.0646873,"RESULTS


Significant alterations were observed in cervical angle (P = .003, effect size = 0.329), shoulder angle (P = .008, effect size = 0.457), neck pain and disability (P = .009, effect size = 0.645), movement control (P ","[{'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Mehri', 'Affiliation': 'Department of Biomechanics and Sport Injuries, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Department of Biomechanics and Sport Injuries, Kharazmi University, Tehran, Iran. Electronic address: letafatkaramir@yahoo.com.'}, {'ForeName': 'Zohre', 'Initials': 'Z', 'LastName': 'Khosrokiani', 'Affiliation': 'Department of Biomechanics and Sport Injuries, Kharazmi University, Tehran, Iran.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2018.11.032']
1557,32728820,Exercise training improves vascular function in patients with Alzheimer's disease.,"PURPOSE


Vascular dysfunction has been demonstrated in patients with Alzheimer's disease (AD). Exercise is known to positively affect vascular function. Thus, the aim of our study was to investigate exercise-induced effects on vascular function in AD.
METHODS


Thirty-nine patients with AD (79 ± 8 years) were recruited and randomly assigned to exercise training (EX, n = 20) or control group (CTRL, n = 19). All subjects performed 72 treatment sessions (90 min, 3 t/w). EX included moderate-high-intensity aerobic and strength training. CTRL included cognitive stimuli (visual, verbal, auditive). Before and after the 6-month treatment, the vascular function was measured by passive-leg movement test (PLM, calculating the variation in blood flow: ∆peak; and area under the curve: AUC) tests, and flow-mediated dilation (FMD, %). A blood sample was analyzed for vascular endothelial growth factor (VEGF). Arterial blood flow (BF) and shear rate (SR) were measured during EX and CTRL during a typical treatment session.
RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ 99.056 ml/min, p = 0.004), AUC (+ 37.359AU, p = 0.037) and VEGF (+ 8.825 pg/ml, p = 0.004). In the CTRL group, no difference between pre- and post-treatment was found for any variable. Increase in BF and SR was demonstrated during EX (BF + 123%, p < 0.05; SR + 134%, p < 0.05), but not during CTRL treatment.
CONCLUSION


Exercise training improves peripheral vascular function in AD. These ameliorations may be due to the repetitive increase in SR during exercise which triggers NO and VEGF upregulation. This approach might be included in standard AD clinical practice as an effective strategy to treat vascular dysfunction in this population.",2020,"RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ ","[""patients with Alzheimer's disease"", ""patients with Alzheimer's disease (AD"", 'Thirty-nine patients with AD (79\u2009±\u20098\xa0years']","['exercise training (EX, n\u2009=\u200920) or control group (CTRL', 'Exercise training']","['Arterial blood flow (BF) and shear rate (SR', 'CTRL included cognitive stimuli (visual, verbal, auditive', 'vascular endothelial growth factor (VEGF', 'passive-leg movement\xa0test (PLM, calculating the variation in blood flow: ∆peak; and area under the curve: AUC) tests, and flow-mediated dilation (FMD, ', 'FMD', 'PLM ∆peak ', 'moderate-high-intensity aerobic and strength training', 'peripheral vascular function', 'vascular function', 'BF and SR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",39.0,0.064598,"RESULTS


EX group has increased FMD% (+ 3.725%, p < 0.001), PLM ∆peak (+ ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedrinolla', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy. massimo.venturelli@univr.it.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fonte', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamburin', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Di Baldassarre', 'Affiliation': ""Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Naro', 'Affiliation': 'Department of Anatomical, Histological, Forensic Medicine and Orthopedic Science, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Varalta', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Giuriato', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ghinassi', 'Affiliation': ""Department of Medicine and Aging Sciences, University G. D'Annunzio, Chieti-Pescara, Chieti, Italy.""}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Muti', 'Affiliation': 'Mons. A. Mazzali Foundation, Mantua, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Schena', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Via Casorati 43, 37131, Verona, Italy.'}]",European journal of applied physiology,['10.1007/s00421-020-04447-w']
1558,32730325,The safety and feasibility of a Halliwick style of aquatic physiotherapy for falls and balance dysfunction in people with Parkinson's Disease: A single blind pilot trial.,"BACKGROUND


There is growing evidence that aquatic physiotherapy may be effective for people with Parkinson's Disease (PD) but most studies have investigated land based type exercises in the aquatic environment. Few studies have examined customised aquatic therapies such as the Halliwick concept which focuses on trunk rotation and core stabilisation.
OBJECTIVE


The primary aim was to determine the feasibility of a Halliwick style aquatic physiotherapy intervention for people with PD. The secondary aim was to compare the Halliwick intervention with traditional aquatic and land based physiotherapy in terms of disease severity, balance and fear of falling.
METHODS


Halliwick style aquatic, traditional aquatic and land based physiotherapy were trialled in a single blind pilot study. All interventions ran for 60 minutes per week over 12 weeks. Feasibility outcomes were safety, adherence and attrition. Secondary outcomes included the Unified Parkinson's Disease Rating Scale motor subsection (UPDRS-III), Berg Balance Scale (BBS), Mini BESTest and modified Falls Efficacy Scale (mFES).
RESULTS


30 participants with moderate PD were recruited. Participant mean age was 72 years (SD 8.4; range 51-86) with moderate disease severity (median Hoehn & Yahr score 3; IQR 1).No falls occurred during intervention sessions, however ten participants reported falls during the study period. No other adverse consequences were reported. All groups had adherence over 85%. No within group significant differences were found in UPDRS-III, BBS or mFES scores post-intervention for all groups, but the Halliwick aquatic group improved significantly in the Mini BESTest post-intervention (p = 0.011, 95% CI -7.36,-1.31, t (10) = -2.98).
CONCLUSIONS


Despite people with PD being a vulnerable population, aquatic physiotherapy, including the Halliwick style is a safe treatment option. Promising results for balance in the Halliwick aquatic group were observed, but further studies with larger sample sizes is required to increase confidence in the results.",2020,"No within group significant differences were found in UPDRS-III, BBS or mFES scores post-intervention for all groups, but the Halliwick aquatic group improved significantly in the Mini BESTest post-intervention (p = 0.011, 95% CI -7.36,-1.31, t (10) = -2.98).
","['Participant mean age was 72 years (SD 8.4; range 51-86) with moderate disease severity (median Hoehn & Yahr score 3; IQR 1).No falls occurred during intervention sessions, however ten participants reported falls during the study period', ""people with Parkinson's Disease"", '30 participants with moderate PD', ""people with Parkinson's Disease (PD"", 'people with PD']","['Halliwick style aquatic, traditional aquatic and land based physiotherapy', 'aquatic physiotherapy', 'Halliwick style aquatic physiotherapy intervention', 'Halliwick intervention with traditional aquatic and land based physiotherapy', 'Halliwick style of aquatic physiotherapy']","['safety, adherence and attrition', 'UPDRS-III, BBS or mFES scores', 'adverse consequences', 'disease severity, balance and fear of falling', ""Unified Parkinson's Disease Rating Scale motor subsection (UPDRS-III), Berg Balance Scale (BBS"", 'Mini BESTest and modified Falls Efficacy Scale (mFES']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0445542', 'cui_str': 'Mini'}]",30.0,0.0617848,"No within group significant differences were found in UPDRS-III, BBS or mFES scores post-intervention for all groups, but the Halliwick aquatic group improved significantly in the Mini BESTest post-intervention (p = 0.011, 95% CI -7.36,-1.31, t (10) = -2.98).
","[{'ForeName': 'Aan Fleur', 'Initials': 'AF', 'LastName': 'Terrens', 'Affiliation': 'Movement Disorder Program, Peninsula Health, VIC, Australia.'}, {'ForeName': 'Sze-Ee', 'Initials': 'SE', 'LastName': 'Soh', 'Affiliation': 'Department of Physiotherapy, Monash University, VIC, Australia.'}, {'ForeName': 'Prue', 'Initials': 'P', 'LastName': 'Morgan', 'Affiliation': 'Department of Physiotherapy, Monash University, VIC, Australia.'}]",PloS one,['10.1371/journal.pone.0236391']
1559,32731960,Cryotherapy With Mobilization Versus Cryotherapy With Mobilization Reinforced With Home Stretching Exercises in Treatment of Chronic Neck Pain: A Randomized Trial.,"OBJECTIVES


The purpose of this study was to compare the effectiveness of cryotherapy with mobilization (CM) vs cryotherapy with mobilization reinforced with home stretching exercises (CMS) on pain and disability.
METHOD


A randomized clinical trial with 2-arm parallel design, concealed allocation, assessor blinding, and intention to-treat analysis. Sixty participants were in 2 groups. Group 1 included cryotherapy with mobilization twice per week for 5 weeks. Group 2 included cryotherapy with mobilization plus home stretching exercises 5 times per week for 5 weeks. The evaluations were at baseline and 2 days posttreatment for the numeric pain rating scale, neck disability index, patient-specific functional scale, and global rating of change.
RESULTS


The CM and CMS decreased neck pain and disability (P = .000). The statistical significance between the groups' differences favored the CM in the numeric pain rating scale, patient-specific functional scale, global rating of change (P = .000), and neck disability index (P = .004).
CONCLUSION


Cryotherapy with mobilization for subjects in this study was more effective in decreasing disability and neck pain than CMS.",2020,"The statistical significance between the groups' differences favored the CM in the numeric pain rating scale, patient-specific functional scale, global rating of change (P = .000), and neck disability index (P = .004).
","['Chronic Neck Pain', 'Sixty participants were in 2 groups']","['Mobilization Reinforced With Home Stretching Exercises', 'Cryotherapy With Mobilization Versus Cryotherapy', 'Cryotherapy with mobilization', 'cryotherapy with mobilization (CM) vs cryotherapy with mobilization reinforced with home stretching exercises (CMS', 'cryotherapy with mobilization plus home stretching exercises', 'cryotherapy with mobilization']","['neck disability index', 'pain and disability', 'disability and neck pain', 'numeric pain rating scale, neck disability index, patient-specific functional scale, and global rating of change', 'numeric pain rating scale, patient-specific functional scale, global rating of change', 'neck pain and disability']","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0041718', 'cui_str': 'Centers for Medicare and Medicaid Services'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",60.0,0.0535214,"The statistical significance between the groups' differences favored the CM in the numeric pain rating scale, patient-specific functional scale, global rating of change (P = .000), and neck disability index (P = .004).
","[{'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Lizis', 'Affiliation': 'Department of Physiotherapy, Cracow College of Health Protection, Cracow, Poland. Electronic address: pawel_lizis@poczta.onet.pl.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kobza', 'Affiliation': 'Physiotherapy Laboratory, Żywiec, Poland.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Manko', 'Affiliation': 'Department of Ergonomics and Physiology of Physical Effort, Jagiellonian University, Cracow, Poland.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Jaszczur-Nowicki', 'Affiliation': 'Department of Tourism, Recreation and Ecology, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Perlinski', 'Affiliation': 'Faculty of Health Sciences, University of Humanities and Economy, Elblag, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Para', 'Affiliation': 'Health Protection, Med-On Company, Liszki, Poland.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2018.11.030']
1560,32732374,The Effect of a Novel Low-Volume Aerobic Exercise Intervention on Liver Fat in Type 2 Diabetes: A Randomized Controlled Trial.,"OBJECTIVE


The aim of this study was to examine the effect of a novel low-volume high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or placebo (PLA) intervention on liver fat, glycemia, and cardiorespiratory fitness using a randomized placebo-controlled design.
RESEARCH DESIGN AND METHODS


Thirty-five inactive adults (age 54.6 ± 1.4 years, 54% male; BMI 35.9 ± 0.9 kg/m 2 ) with obesity and type 2 diabetes were randomized to 12 weeks of supervised MICT ( n  = 12) at 60% VO 2peak  for 45 min, 3 days/week; HIIT ( n  = 12) at 90% VO 2peak  for 4 min, 3 days/week; or PLA ( n  = 11). Liver fat percentage was quantified through proton MRS.
RESULTS


Liver fat reduced in MICT (-0.9 ± 0.7%) and HIIT (-1.7 ± 1.1%) but increased in PLA (1.2 ± 0.5%) ( P  = 0.046). HbA 1c  improved in MICT (-0.3 ± 0.3%) and HIIT (-0.3 ± 0.3%) but not in PLA (0.5 ± 0.2%) ( P  = 0.014). Cardiorespiratory fitness improved in MICT (2.3 ± 1.2 mL/kg/min) and HIIT (1.1 ± 0.5 mL/kg/min) but not in PLA (-1.5 ± 0.9 mL/kg/min) ( P  = 0.006).
CONCLUSIONS


MICT or a low-volume HIIT approach involving 12 min of weekly high-intensity aerobic exercise may improve liver fat, glycemia, and cardiorespiratory fitness in people with type 2 diabetes in the absence of weight loss. Further studies are required to elucidate the relationship between exercise-induced reductions in liver fat and improvements in glycemia.",2020,Cardiorespiratory fitness improved in MICT (2.3 ± 1.2 mL/kg/min) and HIIT (1.1 ± 0.5 mL/kg/min) but not in PLA (-1.5 ± 0.9 mL/kg/min),"['Liver Fat in Type 2 Diabetes', 'Thirty-five inactive adults (age 54.6 ± 1.4 years, 54% male; BMI 35.9 ± 0.9 kg/m 2 ) with obesity and type 2 diabetes']","['supervised MICT', 'Novel Low-Volume Aerobic Exercise Intervention', 'novel low-volume high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or placebo (PLA) intervention', 'PLA', 'placebo']","['liver fat, glycemia, and cardiorespiratory fitness', 'HbA 1c  improved in MICT', 'Cardiorespiratory fitness', 'Liver fat reduced in MICT']","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",35.0,0.0767634,Cardiorespiratory fitness improved in MICT (2.3 ± 1.2 mL/kg/min) and HIIT (1.1 ± 0.5 mL/kg/min) but not in PLA (-1.5 ± 0.9 mL/kg/min),"[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Sabag', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia angelo.sabag@sydney.edu.au.'}, {'ForeName': 'Kimberley L', 'Initials': 'KL', 'LastName': 'Way', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachelle N', 'Initials': 'RN', 'LastName': 'Sultana', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Gerofi', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Vivienne H', 'Initials': 'VH', 'LastName': 'Chuter', 'Affiliation': 'School of Health Sciences, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Nuala M', 'Initials': 'NM', 'LastName': 'Byrne', 'Affiliation': 'School of Health Sciences, College of Health and Medicine, University of Tasmania, Tasmania, Australia.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Baker', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Fitzroy, New South Wales, Australia.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Storr Liver Centre, Westmead Institute for Medical Research and Westmead Hospital, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Caterson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}]",Diabetes care,['10.2337/dc19-2523']
1561,32755802,Distance to white matter trajectories is associated with treatment response to internal capsule deep brain stimulation in treatment-refractory depression.,"BACKGROUND


Deep brain stimulation (DBS) is an innovative treatment for treatment-refractory depression. DBS is usually targeted at specific anatomical landmarks, with patients responding to DBS in approximately 50% of cases. Attention has recently shifted to white matter tracts to explain DBS response, with initial open-label trials targeting white matter tracts yielding much higher response rates (>70%).
OBJECTIVE/HYPOTHESIS


Our aim was to associate distance to individual white matter tracts around the stimulation target in the ventral anterior limb of the internal capsule to treatment response.
METHODS


We performed diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation in fourteen patients that participated in our randomized clinical trial. We combined the tract reconstructions with the postoperative images to identify the DBS leads and estimated the distance between tracts and leads, which we subsequently associated with treatment response.
RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial. Biophysical modelling indicated that 37.5% of tracts were even outside the volume of activated tissue. There was no difference in lead placement with respect to anatomical landmarks, which could mean that differences in treatment response were driven by individual differences in white matter anatomy.
CONCLUSIONS


Our results suggest that deep brain stimulation of the ventral anterior limb of the internal capsule could benefit from targeting white matter bundles. We recommend acquiring diffusion magnetic resonance data for each individual patient.",2020,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.",['fourteen patients that participated in our randomized clinical trial'],"['DBS', 'Deep brain stimulation (DBS', 'diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation']",['lead placement'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0025055', 'cui_str': 'Structure of median forebrain bundle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.085274,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.","[{'ForeName': 'Luka C', 'Initials': 'LC', 'LastName': 'Liebrand', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands. Electronic address: L.C.Liebrand@amsterdamumc.nl.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Natarajan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Matthan W A', 'Initials': 'MWA', 'LastName': 'Caan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'P Richard', 'Initials': 'PR', 'LastName': 'Schuurman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van den Munckhof', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Kwaasteniet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Luigjes', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Isidoor O', 'Initials': 'IO', 'LastName': 'Bergfeld', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Damiaan', 'Initials': 'D', 'LastName': 'Denys', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands; Netherlands Institute for Neuroscience, Royal Academy of Arts and Sciences, Meibergdreef 47, Amsterdam, Netherlands.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'van Wingen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102363']
1562,32729334,Platycodon grandiflorum  Protects Against Anthracycline-Induced Cardiotoxicity in Early Breast Cancer Patients.,"Background:  Anthracycline-based chemotherapy is an effective treatment used for early-stage breast cancer patients. However, anthracycline use is limited due to its cardiotoxic effects. Recent studies have shown that  Platycodon grandiflorum  (PG) protects the heart from anthracycline-induced cardiotoxicity. However, no randomized, placebo-controlled clinical trial has been performed to investigate the clinical use of PG to prevent anthracycline-induced cardiotoxicity. This study aimed to evaluate the cardioprotective effects and safety of PG in early breast cancer patients receiving anthracycline-based chemotherapy.  Methods:  A total of 125 early breast cancer patients receiving anthracycline-based chemotherapy were enrolled and randomized into a PG group or placebo group in a 1:1 ratio.  Results:  Only 2 (3.1%) participants in the placebo group and 1 (1.6%) participant in the PG group experienced NYHA (New York Heart Association) class III or IV heart failure. There were no significant differences observed between the 2 groups. However, compared with the placebo group, patients in the PG group showed a lower incidence of subclinical heart failure (21.9% vs 8.2%, respectively,  P  = .033), as well as lower cardiac troponin T levels (48.4% vs 31.1%, respectively,  P  = .002). Importantly, there were no differences observed in the antitumor effects of anthracycline between the 2 groups (disease-free survival: hazards ratio = 1.09, 95% confidence interval = 0.45-2.62,  P  = .84; overall survival: hazards ratio = 1.46, 95% confidence interval = 0.33-6.43,  P  = .62).  Conclusion:  PG prevents anthracycline-induced acute and chronic cardiac injury in early-stage breast cancer patients without compromising the antitumor effects of chemotherapy.",2020,PG prevents anthracycline-induced acute and chronic cardiac injury in early-stage breast cancer patients without compromising the antitumor effects of chemotherapy.,"['early-stage breast cancer patients', 'early breast cancer patients receiving anthracycline-based chemotherapy', '125 early breast cancer patients receiving', 'Early Breast Cancer Patients']","['chemotherapy', 'anthracycline-based chemotherapy', 'Platycodon grandiflorum  Protects Against Anthracycline-Induced Cardiotoxicity', 'Anthracycline-based chemotherapy', 'anthracycline', 'placebo']","['cardiac troponin T levels', 'antitumor effects of anthracycline', 'subclinical heart failure']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1135815', 'cui_str': 'Balloon Flower'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",125.0,0.285257,PG prevents anthracycline-induced acute and chronic cardiac injury in early-stage breast cancer patients without compromising the antitumor effects of chemotherapy.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': 'Long Hua Hospital, Shanghai, China.'}, {'ForeName': 'Youyang', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Long Hua Hospital, Shanghai, China.'}, {'ForeName': 'Yuenong', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Long Hua Hospital, Shanghai, China.'}, {'ForeName': 'Chenping', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Long Hua Hospital, Shanghai, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Long Hua Hospital, Shanghai, China.'}, {'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Long Hua Hospital, Shanghai, China.'}, {'ForeName': 'Yijia', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Long Hua Hospital, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Long Hua Hospital, Shanghai, China.'}]",Integrative cancer therapies,['10.1177/1534735420945017']
1563,32732587,Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients.,"OBJECTIVE


To assess whether the fixation method and vitamin D supplementation affect the risk of patient-important outcomes within 12 months of injury in nongeriatric femoral neck fracture patients.
DESIGN


A pilot factorial randomized controlled trial.
SETTING


Fifteen North American clinical sites.
PARTICIPANTS


Ninety-one adults 18-60 years of age with a femoral neck fracture requiring surgical fixation.
INTERVENTION


Participants were randomized to a surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D3 4000 IU daily vs. placebo for 6 months).
MAIN OUTCOME MEASUREMENTS


The primary clinical outcome was a composite of patient-important complications (reoperation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion). Secondary outcomes included fracture-healing complications and radiographic fracture healing.
RESULTS


Eighty-six participants with a mean age of 41 years were included. We found no statistically significant difference in the risk of patient-important outcomes between the surgical treatment arms (hazard ratio 0.90, 95% confidence interval 0.40-2.02, P = 0.80) and vitamin D supplementation treatment arms (hazard ratio 0.96, 95% confidence interval 0.42-2.18, P = 0.92).
CONCLUSIONS


These pilot trial results continue to describe the results of current fixation implants, inform the challenges of improving outcomes in this fracture population, and may guide future vitamin D trials to improve healing outcomes in young fracture populations. Although the pilot trial was not adequately powered to detect treatment effects, publishing these results may facilitate future meta-analyses on this topic.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"We found no statistically significant difference in the risk of patient important outcomes between the surgical treatment arms (hazard ratio (HR) 0.90, 95% CI 0.40-2.02, p=0.80) and vitamin D supplementation treatment arms (HR 0.96, 95% CI 0.42- 2.18, p=0.92).
","['15 North American clinical sites', '91 adults aged 18-60 years with a femoral neck fracture requiring surgical fixation', 'Young Femoral Neck Fracture Patients', '86 participants with a mean age of 41 years were included', 'young fracture populations', '12 months of injury in non-geriatric femoral neck fracture patients', 'Hip Fractures (FAITH-2']","['surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D3 4,000 IU daily versus placebo', 'fixation method and vitamin D supplementation', 'Fixation using Alternative Implants']","['composite of patient important complications (re-operation, femoral head osteonecrosis, severe femoral neck malunion, nonunion', 'healing outcomes', 'risk of patient important outcomes', 'fracture healing complications and radiographic fracture healing']","[{'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0310589', 'cui_str': 'Vitamin A- and vitamin D-containing product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}]",91.0,0.184045,"We found no statistically significant difference in the risk of patient important outcomes between the surgical treatment arms (hazard ratio (HR) 0.90, 95% CI 0.40-2.02, p=0.80) and vitamin D supplementation treatment arms (HR 0.96, 95% CI 0.42- 2.18, p=0.92).
","[{'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': 'OʼToole', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Howe', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Gaski', 'Affiliation': 'Department of Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Hill', 'Affiliation': 'Department of Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Krista M', 'Initials': 'KM', 'LastName': 'Brown', 'Affiliation': 'Department of Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Viskontas', 'Affiliation': 'Department of Orthopaedics, University of British Columbia, New Westminster, BC, Canada.'}, {'ForeName': 'Mauri', 'Initials': 'M', 'LastName': 'Zomar', 'Affiliation': 'Division of Orthopaedics, Fraser Health Authority, New Westminster, BC, Canada.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Della Rocca', 'Affiliation': 'Department of Orthopaedic Surgery, University of Missouri, Columbia, MO.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': 'OʼHara', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001773']
1564,32732620,Impaired Vagal Efficiency Predicts Auricular Neurostimulation Response in Adolescent Functional Abdominal Pain Disorders.,"INTRODUCTION


To determine whether pretreatment vagal efficiency (VE), respiratory sinus arrhythmia, and heart period can predict pain improvement with auricular neurostimulation in pediatric functional abdominal pain disorders.
METHODS


A total of 92 adolescents with functional abdominal pain disorders underwent a 4-week randomized, double-blinded, sham-controlled auricular neurostimulation trial. Electrocardiogram-derived variables at baseline were used to predict pain using mixed effects modeling.
RESULTS


A 3-way interaction (95% confidence intervals: 0.004-0.494) showed that the treatment group subjects with low baseline VE had lower pain scores at week 3. There was no substantial change in the placebo or high VE treatment group subjects. This effect was supported by a significant correlation between baseline VE and degree of pain reduction only in the treatment group.
DISCUSSION


Impaired cardiac vagal regulation measured by VE predicts pain improvement with auricular neurostimulation.",2020,A 3-way interaction (95% confidence intervals: 0.004-0.494) showed that the treatment group subjects with low baseline VE had lower pain scores at week 3.,"['pediatric functional abdominal pain disorders', '92 adolescents with functional abdominal pain disorders', 'Adolescent Functional Abdominal Pain Disorders']",['placebo'],"['pain scores', 'Impaired cardiac vagal regulation', 'pain reduction']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",92.0,0.420766,A 3-way interaction (95% confidence intervals: 0.004-0.494) showed that the treatment group subjects with low baseline VE had lower pain scores at week 3.,"[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Kovacic', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kolacz', 'Affiliation': 'Socioneural Physiology Laboratory, Kinsey Institute, Indiana University, Bloomington, Indiana, USA.'}, {'ForeName': 'Gregory F', 'Initials': 'GF', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Porges', 'Affiliation': 'Traumatic Stress Research Consortium, Kinsey Institute, Indiana University, Bloomington, Indiana, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000753']
1565,32730283,"Comparison of Glidescope® Go™, King Vision™, Dahlhausen VL, I‑View™ and Macintosh laryngoscope use during difficult airway management simulation by experienced and inexperienced emergency medical staff: A randomized crossover manikin study.","BACKGROUND


In pre-hospital emergency care, video laryngoscopes (VLs) with disposable blades are preferably used due to hygienic reasons. However, there is limited existing data on the use of VLs with disposable blades by emergency medical staff. Therefore, the aim of this study was to compare the efficacy of four different VLs with disposable blades and the conventional standard Macintosh laryngoscope, when used by anesthetists with extensive previous experience and paramedics with little previous experience in endotracheal intubation (ETI) in a simulated difficult airway.
METHODS


Fifty-eight anesthetists and fifty-four paramedics participated in our randomized crossover manikin trial. Each performed ETI with the new Glidescope® Go™, the Dahlhausen VL, the King Vision™, the I-View™ and the Macintosh laryngoscope. ""Time to intubate"" was the primary endpoint. Secondary endpoints were ""time to vocal cords"", ""time to ventilate"", overall success rate, number of intubation attempts and optimization maneuvers, Cormack-Lehane score, severity of dental compression and subjective impressions.
RESULTS


The Glidescope® Go™, the Dahlhausen VL and the King Vision™ provided superior intubation conditions in both groups without affecting the number of intubation attempts or the time required for successful intubation. When used by anesthetists with extensive experience in ETI, the use of VLs did not affect the overall success rate. In the hands of paramedics with little previous experience in ETI, the failure rate with the Macintosh laryngoscope (14.8%) decreased to 3.7% using the Glidescope® Go™ and the Dahlhausen VL. Despite the advantages of hyperangulated video laryngoscopes, the I-View™ performed worst.
CONCLUSIONS


VLs with hyperangulated blades facilitated ETI in both groups and decreased the failure rate by an absolute 11.1% when used by paramedics with little previous experience in ETI. Our results therefore suggest that hyperangulated VLs could be beneficial and might be the method of choice in comparable settings, especially for emergency medical staff with less experience in ETI.",2020,"CONCLUSIONS


VLs with hyperangulated blades facilitated ETI in both groups and decreased the failure rate by an absolute 11.1% when used by paramedics with little previous experience in ETI.",['Fifty-eight anesthetists and fifty-four paramedics participated'],"['conventional standard Macintosh laryngoscope', 'endotracheal intubation (ETI']","['number of intubation attempts or the time required for successful intubation', 'overall success rate', 'failure rate', 'Dahlhausen VL and the King Vision™', 'time to vocal cords"", ""time to ventilate"", overall success rate, number of intubation attempts and optimization maneuvers, Cormack-Lehane score, severity of dental compression and subjective impressions']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",58.0,0.028898,"CONCLUSIONS


VLs with hyperangulated blades facilitated ETI in both groups and decreased the failure rate by an absolute 11.1% when used by paramedics with little previous experience in ETI.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Moritz', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Leonhardt', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Prottengeier', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Birkholz', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Irouschek', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}]",PloS one,['10.1371/journal.pone.0236474']
1566,32730905,Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patient undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial.,"BACKGROUND


New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization.
STUDY DESIGN


This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months.
SUMMARY


This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.",2020,"The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months.","['200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI', 'patients with peripheral artery disease (PAD) undergoing arterial angioplasty', 'patients undergoing InfraPoPliteal angioplasty for critical limb ischemia', 'patients with CLI undergoing endovascular infrapopliteal revascularization', 'patients undergoing endovascular infrapopliteal revascularization']","['apixaban plus aspirin', 'apixaban 2.5 mg twice daily plus aspirin', 'Apixaban versus ClopidoGRel', 'standard of care dual antiplatelet therapy (DAPT', 'DAPT (clopidogrel plus aspirin', 'aspirin', 'clopidogrel', 'oral apixaban']","['composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death', 'thrombotic restenosis and artery re-occlusion', 'composite of major bleeding or clinically relevant non-major bleeding at 12 months', 'efficacy and safety']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0397654', 'cui_str': 'Angioplasty of artery'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3530461', 'cui_str': 'apixaban 2.5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.221901,"The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months.","[{'ForeName': 'Rodrigo Bruno', 'Initials': 'RB', 'LastName': 'Biagioni', 'Affiliation': 'São Paulo State Public Servant Hospital, São Paulo, Brazil. Electronic address: rbbiagioni@gmail.com.'}, {'ForeName': 'Renato Delascio', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Leandro Barile', 'Initials': 'LB', 'LastName': 'Agati', 'Affiliation': 'Science Valley Research Institute, Santo André, São Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sacilotto', 'Affiliation': 'São Paulo State Public Servant Hospital, São Paulo, Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Wolosker', 'Affiliation': 'Albert Einstein Hospital, São Paulo, Brazil; Hospital das Clínicas de São Paulo, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Marcone Lima', 'Initials': 'ML', 'LastName': 'Sobreira', 'Affiliation': 'Universidade Estadual Paulista (UNESP), Botucatu, Brazil.'}, {'ForeName': 'Bruno Leonardo', 'Initials': 'BL', 'LastName': 'de Freitas Soares', 'Affiliation': 'Santa Casa de Maceio, Maceio, Alagoas, Brazil.'}, {'ForeName': 'Edwaldo Edner', 'Initials': 'EE', 'LastName': 'Joviliano', 'Affiliation': 'Hospital das Clínicas de Ribeirão Preto, São Paulo University Medical School (USP), Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Walkiria Hueb', 'Initials': 'WH', 'LastName': 'Bernardi', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Valter Castelli', 'Initials': 'VC', 'LastName': 'Junior', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Roberto Augusto', 'Initials': 'RA', 'LastName': 'Caffaro', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Fioranelli', 'Affiliation': 'Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}, {'ForeName': 'Bonno', 'Initials': 'B', 'LastName': 'Van Bellen', 'Affiliation': 'Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ivan Benaduce', 'Initials': 'IB', 'LastName': 'Casella', 'Affiliation': 'Hospital das Clínicas de São Paulo, São Paulo University, São Paulo, Brazil.'}, {'ForeName': 'Ronald José Ribeiro', 'Initials': 'RJR', 'LastName': 'Fidelis', 'Affiliation': 'Vascular and Endovascular Surgery-Federal University of Bahia.'}, {'ForeName': 'Ronald Luiz Gomes', 'Initials': 'RLG', 'LastName': 'Flumignan', 'Affiliation': 'Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anthony James', 'Initials': 'AJ', 'LastName': 'Comerota', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ramacciotti', 'Affiliation': 'Hemostasis & Thrombosis Research Laboratories at Loyola University Medical Center, Maywood, IL, USA; Santa Casa de São Paulo School of Medical Sciences, São Paulo, Brazil.'}]",American heart journal,['10.1016/j.ahj.2020.06.010']
1567,32732305,Effect of Intensive Glycemic and Blood Pressure Control on QT Prolongation in Diabetes: The ACCORD Trial.,"Compared with standard glycemic control, intensive glycemic control caused increased mortality in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Preliminary data from several studies suggest that intensive glycemic control is associated with QT prolongation, which may lead to ventricular arrhythmias as a possible explanation of this increased mortality. We sought to assess the effects of intensive glycemic control and intensive blood pressure control on the risk of incident QT prolongation. Cox proportional hazards models were used to compare the risk of incident QT prolongation (>460 ms in women or >450 ms in men) in the intensive versus standard glycemic control arms. Over a combined 48,634 person-years of follow-up (mean 4.9), 634 participants (6.4%) developed a prolonged QTc. Participants in the intensive glycemic control arm did not have an increased risk of QT prolongation. Similarly, a strategy of intensive blood pressure control did not result in a significant change in risk of prolonged QTc. Sensitivity analyses using alternative QT correction formulas (Hodges and Bazett) yielded overall similar findings. In conclusion, the increased mortality observed in the intensive glycemic control arm in the ACCORD trial is not likely to be explained by QT prolongation leading to lethal ventricular arrhythmias.",2020,Participants in the intensive glycemic control arm did not have an increased risk of QT prolongation.,['Diabetes'],"['Intensive Glycemic and Blood Pressure Control', 'intensive glycemic control and intensive blood pressure control']","['risk of QT prolongation', 'risk of prolonged QTc', 'mortality']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0626446,Participants in the intensive glycemic control arm did not have an increased risk of QT prolongation.,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Singleton', 'Affiliation': 'Section of Cardiology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC mjsingle@wakehealth.edu.'}, {'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': 'Section of Cardiology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Bertoni', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'S Patrick', 'Initials': 'SP', 'LastName': 'Whalen', 'Affiliation': 'Section of Cardiology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Prashant D', 'Initials': 'PD', 'LastName': 'Bhave', 'Affiliation': 'Section of Cardiology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Yeboah', 'Affiliation': 'Section of Cardiology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}]",Diabetes,['10.2337/db20-0401']
1568,32736299,"A beverage containing ora-pro-nobis flour improves intestinal health, weight, and body composition: A double-blind randomized prospective study.","OBJECTIVE


The aim of this study was to verify the effect of a beverage containing ora-pro-nobis (OPN) flour on intestinal microbiota, gastrointestinal symptoms, and anthropometric parameters in women.
METHODS


This prospective, double-blinded, randomized clinical trial included 24 women volunteers. For 6 wk, the test group received a beverage supplemented with OPN, and the control group received the same beverage without OPN. Fecal microbiota were evaluated by the fluorescence in situ hybridization method. Each participant responded to a questionnaire based on the Gastrointestinal Symptom Rating Scale. The data were analyzed by Student's t test to compare the effects between treatments (P < 0.05).
RESULTS


Supplementation with the OPN beverage reduced weight (P = 0.008), waist circumference (P = 0.010), and body fat (P = 0.000). Additionally, the treatment increased satiety (P = 0.039), reduced eructation (P = 0.038) and constipation (P = 0.017), and improved feces consistency (P = 0.017).
CONCLUSION


The OPN flour beverage has an effect on weight reduction, body fat composition, and improvement in gastrointestinal symptoms. These results highlight the beneficial effects of ora-pro-nobis flour beverage against the development of obesity.",2020,"RESULTS


Supplementation with the OPN beverage reduced weight (P = 0.008), waist circumference (P = 0.010), and body fat (P = 0.000).","['24 women volunteers', 'women']","['beverage containing ora-pro-nobis (OPN) flour', 'beverage supplemented with OPN, and the control group received the same beverage without OPN']","['weight', 'waist circumference', 'feces consistency', 'satiety', 'Gastrointestinal Symptom Rating Scale', 'intestinal health, weight, and body composition', 'weight reduction, body fat composition, and improvement in gastrointestinal symptoms', 'reduced eructation', 'Fecal microbiota', 'intestinal microbiota, gastrointestinal symptoms, and anthropometric parameters', 'body fat', 'constipation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",24.0,0.165472,"RESULTS


Supplementation with the OPN beverage reduced weight (P = 0.008), waist circumference (P = 0.010), and body fat (P = 0.000).","[{'ForeName': 'Camilla Ribeiro', 'Initials': 'CR', 'LastName': 'Vieira', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Grancieri', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Brazil.'}, {'ForeName': 'Hércia Stampini Duarte', 'Initials': 'HSD', 'LastName': 'Martino', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Brazil.'}, {'ForeName': 'Dionéia Evangelista', 'Initials': 'DE', 'LastName': 'César', 'Affiliation': 'Department of Biology, Universidade Federal de Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Roberta Ribeiro Silva', 'Initials': 'RRS', 'LastName': 'Barra', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil. Electronic address: betaribeiro@hotmail.com.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110869']
1569,32737637,Open versus minimally invasive total gastrectomy after neoadjuvant chemotherapy: results of a European randomized trial.,"BACKGROUND


Surgical resection with adequate lymphadenectomy is regarded the only curative option for gastric cancer. Regarding minimally invasive techniques, mainly Asian studies showed comparable oncological and short-term postoperative outcomes. The incidence of gastric cancer is lower in the Western population and patients often present with more advanced stages of disease. Therefore, the reproducibility of these Asian results in the Western population remains to be investigated.
METHODS


A randomized trial was performed in thirteen hospitals in Europe. Patients with an indication for total gastrectomy who received neoadjuvant chemotherapy were eligible for inclusion and randomized between open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG). Primary outcome was oncological safety, measured as the number of resected lymph nodes and radicality. Secondary outcomes were postoperative complications, recovery and 1-year survival.
RESULTS


Between January 2015 and June 2018, 96 patients were included in this trial. Forty-nine patients were randomized to OTG and 47 to MITG. The mean number of resected lymph nodes was 43.4 ± 17.3 in OTG and 41.7 ± 16.1 in MITG (p = 0.612). Forty-eight patients in the OTG group had a R0 resection and 44 patients in the MITG group (p = 0.617). One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701). No significant differences were found regarding postoperative complications and recovery.
CONCLUSION


These findings provide evidence that MITG after neoadjuvant therapy is not inferior regarding oncological quality of resection in comparison to OTG in Western patients with resectable gastric cancer. In addition, no differences in postoperative complications and recovery were seen.",2020,One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701).,"['Between January 2015 and June 2018, 96 patients were included in this trial', 'thirteen hospitals in Europe', 'Patients with an indication for total gastrectomy who received', 'Western patients with resectable gastric cancer', 'Forty-nine patients']","['open total gastrectomy (OTG) or minimally invasive total gastrectomy (MITG', 'OTG', 'Open versus minimally invasive total gastrectomy after neoadjuvant chemotherapy', 'neoadjuvant chemotherapy']","['oncological safety, measured as the number of resected lymph nodes and radicality', 'mean number of resected lymph nodes', 'One-year survival', 'gastric cancer', 'postoperative complications, recovery and 1-year survival', 'postoperative complications and recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439234', 'cui_str': 'year'}]",49.0,0.107117,One-year survival was 90.4% in OTG and 85.5% in MITG (p = 0.701).,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'van der Wielen', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands. ni.vanderwielen@amsterdamumc.nl.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Straatman', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Freek', 'Initials': 'F', 'LastName': 'Daams', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Rosati', 'Affiliation': 'Department of Surgery, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Parise', 'Affiliation': 'Department of Surgery, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'Department of Visceral-, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Reissfelder', 'Affiliation': 'Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Ismael', 'Initials': 'I', 'LastName': 'Diez Del Val', 'Affiliation': 'Department of Surgery, Hospital Universitario de Basurto, Bilbao, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Loureiro', 'Affiliation': 'Department of Surgery, Hospital Universitario de Basurto, Bilbao, Spain.'}, {'ForeName': 'Purificación', 'Initials': 'P', 'LastName': 'Parada-González', 'Affiliation': 'Department of Surgery, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pintos-Martínez', 'Affiliation': 'Department of Surgery, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Mateo Vallejo', 'Affiliation': 'Department of Surgery, Hospital de Jerez, Jerez de la Frontera, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Medina Achirica', 'Affiliation': 'Department of Surgery, Hospital de Jerez, Jerez de la Frontera, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Sánchez-Pernaute', 'Affiliation': 'Department of Surgery, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Ruano Campos', 'Affiliation': 'Department of Surgery, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bonavina', 'Affiliation': 'Department of Surgery, IRCCS Policlinico San Donato, Milan, Italy.'}, {'ForeName': 'Emanuele L G', 'Initials': 'ELG', 'LastName': 'Asti', 'Affiliation': 'Department of Surgery, IRCCS Policlinico San Donato, Milan, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Alonso Poza', 'Affiliation': 'Department of Surgery, Hospital del Sureste, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gilsanz', 'Affiliation': 'Department of Surgery, Hospital del Sureste, Madrid, Spain.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Surgery, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lindblad', 'Affiliation': 'Department of Surgery, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Gisbertz', 'Affiliation': 'Department of Gastro-intestinal Surgery, Amsterdam University Medical Center Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Gastro-intestinal Surgery, Amsterdam University Medical Center Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Uberto', 'Initials': 'U', 'LastName': 'Fumagalli Romario', 'Affiliation': 'Department of Surgery, ASST Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'De Pascale', 'Affiliation': 'Department of Surgery, ASST Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Khurshid', 'Initials': 'K', 'LastName': 'Akhtar', 'Affiliation': 'Department of Surgery, Salford Royal NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jaap Bonjer', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Cuesta', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'van der Peet', 'Affiliation': 'Department of Gastro-Intestinal Surgery, Amsterdam University Medical Center, Location VU University, De Boelelaan 1117, ZH 7F020, 1081 HV, Amsterdam, The Netherlands.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01109-w']
1570,32735552,Progestogen addition with low-dose levonorgestrel intrauterine system in menopausal hormone treatment gives less normal breast tissue proliferation than oral norethisterone acetate or medroxyprogesterone acetate.,"Background The impact of hormones on the development of breast cancer is despite extensive studies, incompletely understood. Combined estrogen-progestogen treatment augments the risk for breast cancer beyond that of estrogen alone, according to numerous studies. The role of breast cell proliferation as a promoter in the development and growth of breast cancer is well recognized. Materials and methods Seventy-nine patients from three randomised trials were subject to a re-analysis of breast cell proliferation: (1) 22 women received continuous combined treatment with oral estradiol (E2) 2 mg/norethisterone acetate (NETA) 1 mg once daily for 3 months. (2) Thirty-seven women received 2 months of sequential treatment with oral conjugated equine estrogens (CEE) 0.625 mg daily combined with medroxyprogesterone acetate (MPA) 5 mg for 14/28 days of each cycle. (3) Twenty women received oral estradiol-valerate (E2V) 2 mg daily combined with levonorgestrel (LNG) intrauterine system (IUS), 20 μg/24 h for 2 months. Fine needle aspiration (FNA) (studies 1 and 3) and core needle biopsy (CNB) (study 2) were used for the assessment of breast cell proliferation. Results There were no baseline proliferation differences, but at the end of treatment there was a highly significant between-group difference for E2V/LNG IUS versus the other two groups (p = 0.0025). E2/NETA and CEE treatments gave a 4-7-old increase in proliferation during treatment (p = 0.04) and (p = 0.007), respectively, which was absent in the E2V/LNG group, showing a significant correlation with insulin-like growth factor binding protein-3 (IGFBP-3) serum levels. Conclusion E2V in combination with very low serum concentrations of LNG in the IUS gives no increase in proliferation in the normal breast.",2020,"There were no baseline proliferation differences, but at the end of treatment there was a highly significant between-group difference for E2V/LNG IUS versus the other two groups (p = 0.0025).","['2) Thirty-seven women', 'Materials and methods Seventy-nine patients from three randomised trials were subject to a re-analysis of breast cell proliferation: (1) 22 women received']","['continuous combined treatment with oral estradiol (E2) 2 mg/norethisterone acetate (NETA', 'oral conjugated equine estrogens (CEE) 0.625 mg daily combined with medroxyprogesterone acetate (MPA', 'Combined estrogen-progestogen treatment', 'Progestogen addition with low-dose levonorgestrel intrauterine system', 'Fine needle aspiration (FNA) (studies 1 and 3) and core needle biopsy (CNB', 'norethisterone acetate or medroxyprogesterone acetate', 'E2V) 2 mg daily combined with levonorgestrel (LNG) intrauterine system (IUS', 'oral estradiol-valerate']","['normal breast tissue proliferation', 'insulin-like growth factor binding protein-3 (IGFBP-3) serum levels', 'proliferation']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0596290', 'cui_str': 'Cellular Proliferation'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0985842', 'cui_str': 'Estradiol 2 MG'}, {'cui': 'C0068980', 'cui_str': 'Norethindrone acetate'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C4517467', 'cui_str': '0.625'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0059623', 'cui_str': 'Estradiol valerate'}]","[{'cui': 'C0567498', 'cui_str': 'Breast normal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",79.0,0.0672585,"There were no baseline proliferation differences, but at the end of treatment there was a highly significant between-group difference for E2V/LNG IUS versus the other two groups (p = 0.0025).","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lundström', 'Affiliation': ""Division for Obstetrics and Gynecology, Department of Children's and Women's Health, Karolinska Institutet, Karolinska University Hospital, SE-171 76, Stockholm, Sweden.""}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Virijevic', 'Affiliation': 'Department of Obstetrics and Gynecology, Västerås Hospital, Västerås, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Söderqvist', 'Affiliation': ""Division for Obstetrics and Gynecology, Department of Children's and Women's Health, Karolinska Institutet, Karolinska University Hospital, SE-171 76, Stockholm, Sweden.""}]",Hormone molecular biology and clinical investigation,['10.1515/hmbci-2019-0051']
1571,32735987,"A two-site, open-label, non-randomized trial comparing Focal Electrically-Administered Seizure Therapy (FEAST) and right unilateral ultrabrief pulse electroconvulsive therapy (RUL-UBP ECT).","BACKGROUND


Focal Electrically-Administered Seizure Therapy (FEAST) is a form of electroconvulsive therapy (ECT) that spatially focuses the electrical stimulus to initiate seizure activity in right prefrontal cortex. Two open-label non-comparative studies suggested that FEAST has reduced cognitive side effects when compared to historical data from other forms of ECT. In two different ECT clinics, we compared the efficacy and cognitive side effects of FEAST and Right Unilateral Ultrabrief Pulse (RUL-UBP) ECT.
METHODS


Using a non-randomized, open-label design, 39 depressed adults were recruited after referral for ECT. Twenty patients received FEAST (14 women; age 45.2 ± 12.7), and 19 received RUL-UBP ECT (16 women; age 43.2 ± 16.4). Key cognitive outcome measures were the postictal time to reorientation and the Columbia University Autobiographical Memory Interview: Short-Form (CUAMI-SF). Antidepressant effects were assessed using the Hamilton Rating Scale for Depression (HRSD 24 ).
RESULTS


In the Intent-to-treat sample, a repeated measures mixed model suggested no between group difference in HRSD 24  score over time (F 1,35  = 0.82, p = 0.37), while the response rate favored FEAST (FEAST: 65%; RUL-UBP ECT: 57.9%), and the remission rate favored RUL-UBP ECT (FEAST: 35%; RUL-UBP ECT: 47.4%). The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6 ± 5.0 min; RUL-UBP ECT: 8.8 ± 5.8 min; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2 ± 14.2%; RUL-UBP ECT: 63.9 ± 9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
CONCLUSIONS


FEAST exerts similar efficacy relative to an optimal form of conventional ECT and may have milder cognitive side effects. A blinded, randomized, non-inferiority trial is needed.",2020,"The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6±5.0 minutes; RUL-UBP ECT: 8.8±5.8 minutes; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2±14.2%; RUL-UBP ECT: 63.9±9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
","['Twenty patients received FEAST (14 women; age 45.2±12.7), and 19 received', '39 depressed adults were recruited after referral for ECT']","['electroconvulsive therapy (ECT', 'FEAST and Right Unilateral Ultrabrief Pulse (RUL-UBP) ECT', 'Focal Electrically-Administered Seizure Therapy (FEAST) and Right Unilateral Ultrabrief Pulse Electroconvulsive Therapy (RUL-UBP ECT', 'RUL-UBP ECT', 'FEAST', 'Focal Electrically-Administered Seizure Therapy (FEAST']","['cognitive side effects', 'CUAMI-SF consistency score', 'efficacy and cognitive side effects', 'postictal time to reorientation and the Columbia University Autobiographical Memory Interview: Short-Form (CUAMI-SF', 'Hamilton Rating Scale for Depression (HRSD 24 ', 'numeric superiority', 'Antidepressant effects', 'HRSD 24  score over time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0451013', 'cui_str': 'Autobiographical memory interview'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",39.0,0.0739028,"The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6±5.0 minutes; RUL-UBP ECT: 8.8±5.8 minutes; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2±14.2%; RUL-UBP ECT: 63.9±9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
","[{'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Sahlem', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA. Electronic address: sahlem@musc.edu.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'E Baron', 'Initials': 'EB', 'LastName': 'Short', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Fox', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Youssef', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Manett', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Kerns', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Morgan M', 'Initials': 'MM', 'LastName': 'Dancy', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Laryssa', 'Initials': 'L', 'LastName': 'McCloud', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA; Ralph H. Johnson VA Medical Center, SC, USA.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Departments of Psychiatry and Radiology, Columbia University, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.07.015']
1572,32738573,"Effect of multispecies probiotic on gut microbiota composition in individuals with intestinal constipation: A double-blind, placebo-controlled randomized trial.","OBJECTIVE


The aim of this study was to evaluate the effect of a multispecies probiotic on gut microbiota composition and constipation symptoms.
METHODS


A randomized, double-blind, placebo-controlled clinical trial was conducted with 35 individuals with constipation for 30 days. The individuals were randomized into two groups: the control capsule (CC) and the probiotic capsule (PC) groups. Constipation symptoms were evaluated by the ROME IV criteria and by evacuation diaries. Fecal microbiota was analyzed by 16 S rRNA gene sequencing.
RESULTS


The majority of participants were women (85.7%). There was a significant reduction in the percent of participants who had incomplete defecation (P = 0.034), blockage sensation (P = 0.025), and rarely present liquid stools without the aid of laxatives (P = 0.046) only within the PC group (but no significant difference between groups). There was a significant increase in the relative abundance percentage of Blautia faecis and Ruminococcus torques in the CC group (P = 0.003 and P = 0.011, respectively), although there was no significant change in the PC group (P = 0.794 and P = 0.958, respectively), with a significant difference between groups (P = 0.029 and P 0.013, respectively), suggesting that probiotic treatment prevented the increase of percent relative abundance of these two species.
CONCLUSION


These results suggest that multispecies probiotics in capsule form may modulate gut microbiota by reducing the bacteria that are commonly increased in patients with constipation, contributing to the balance of microbiota and, consequently, to the well-being of the individual. Future studies with larger numbers of patients are required.",2020,"There was a significant reduction in the percent of participants who had incomplete defecation (P = 0.034), blockage sensation (P = 0.025), and rarely present liquid stools without the aid of laxatives (P = 0.046) only within the PC group (but no significant difference between groups).","['individuals with intestinal constipation', '35 individuals with constipation for 30 days', 'patients with constipation']","['control capsule (CC) and the probiotic capsule (PC', 'multispecies probiotic', 'placebo']","['incomplete defecation', 'gut microbiota composition and constipation symptoms', 'Constipation symptoms', 'blockage sensation', 'Fecal microbiota', 'gut microbiota composition', 'relative abundance percentage of Blautia faecis and Ruminococcus torques']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2658870', 'cui_str': 'Blautia'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",35.0,0.289849,"There was a significant reduction in the percent of participants who had incomplete defecation (P = 0.034), blockage sensation (P = 0.025), and rarely present liquid stools without the aid of laxatives (P = 0.046) only within the PC group (but no significant difference between groups).","[{'ForeName': 'Patrícia Borges', 'Initials': 'PB', 'LastName': 'Botelho', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil. Electronic address: patriciabotelho@unb.br.'}, {'ForeName': 'Marcus Vinícius Rodrigues', 'Initials': 'MVR', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Ananda de Mesquita', 'Initials': 'AM', 'LastName': 'Araújo', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Marcela Moraes', 'Initials': 'MM', 'LastName': 'Mendes', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Eduardo Yoshio', 'Initials': 'EY', 'LastName': 'Nakano', 'Affiliation': 'Statistics Department, University of Brasilia, Brasília, Brazil.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110890']
1573,32741832,"""Camminando e Leggendo ...   Ricordo"" (Walking and Reading ...   I Remember): Prevention of Frailty Through the Promotion of Physical Activity and Reading in People with Mild Cognitive Impairment. Results from the TREDEM Registry.","BACKGROUND


Frailty is a condition of increased vulnerability to exogenous and endogenous stressors, which is correlated with aging, functional decline, institutionalization, hospitalization, and mortality. Given the multifaceted nature of frailty, programs aimed at its prevention are recommended to act on multiple domains.
OBJECTIVE


The present intervention program aimed at assessing the effects of combined physical and cognitive training in older people with mild cognitive impairment (MCI) and at investigating how their frailty status changed over one year of follow-up.
METHODS


Two-hundred and seven participants were recruited among outpatients of the Cognitive Impairment Center who agreed to receive a comprehensive assessment. Forty-six participants, who joined a structured program of physical activity and group readings for a period of one year, were defined as active. The remaining 161, who decided not to engage in those activities, were considered controls. In both groups, frailty status was assessed at baseline and over one year of follow-up.
RESULTS


Control participants showed twice the risk of becoming frail at 12 months compared with those in the active group. Participants in the active group had more than three times the probability of improving their frailty status compared with the control group from T0 to T12. Age and NPI scores were significantly associated with worsening frailty status. When analyses were restricted to participants who were robust at baseline, the frailty status varied significantly between groups over time.
CONCLUSION


Findings of the present study confirm the beneficial effects of physical activity and reading to prevent frailty in older people with MCI.",2020,Participants in the active group had more than three times the probability of improving their frailty status compared with the control group from T0 to T12.,"['older people with mild cognitive impairment (MCI', 'older people with MCI', 'Forty-six participants, who joined a structured program of physical activity and group readings for a period of one year, were defined as active', 'People with Mild Cognitive Impairment', 'Two-hundred and seven participants were recruited among outpatients of the Cognitive Impairment Center who agreed to receive a comprehensive assessment']",['combined physical and cognitive training'],"['Age and NPI scores', 'risk of becoming frail', 'frailty status', 'probability of improving their frailty status']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",207.0,0.0444372,Participants in the active group had more than three times the probability of improving their frailty status compared with the control group from T0 to T12.,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Gallucci', 'Affiliation': 'Cognitive Impairment Center, Local Health Authority n. 2 Marca Trevigiana, Treviso, Italy.'}, {'ForeName': 'Anna Paola', 'Initials': 'AP', 'LastName': 'Mazzarolo', 'Affiliation': 'Cognitive Impairment Center, Local Health Authority n. 2 Marca Trevigiana, Treviso, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Focella', 'Affiliation': 'Cognitive Impairment Center, Local Health Authority n. 2 Marca Trevigiana, Treviso, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Piovesan', 'Affiliation': 'Epidemiology Unit, Local Health Authority n. 2 Marca Trevigiana, Treviso, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Mazzetto', 'Affiliation': 'Health Promotion Unit, Local Health Authority n. 2 Marca Trevigiana, Treviso, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Ramigni', 'Affiliation': 'Epidemiology Unit, Local Health Authority n. 2 Marca Trevigiana, Treviso, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Marzetti', 'Affiliation': 'Institute of Internal Medicine and Geriatrics, Università Cattolica del Sacro Cuore, Rome, Italy.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200542']
1574,32742637,The effectiveness of a contingent financial incentive to improve trial follow up; a randomised study within a trial (SWAT).,"Objectives  To evaluate the effectiveness of a contingent financial incentive (£10 note in addition to a routinely provided £10 voucher) versus no contingent financial incentive, on improving the retention rate in a randomised controlled trial (RCT).  Methods  A two arm 'Study within a Trial' (SWAT) embedded within a host RCT (SCIMITAR+). Participants were randomised to the SWAT using a 2:1 (intervention:control) allocation ratio. The primary outcome measure was the proportion of participants completing a CO breath measurement at the first SCIMITAR+ follow up time point (6 months). Secondary outcomes were withdrawing from follow-up after contact and time from assessment due date to completion.  Analyses were conducted using logistic or Cox Proportional Hazards regression as appropriate.  Results  A total of 434 participants were randomised into this SWAT. Completion of the CO breath measurement at 6 months was 88.5% (n=247) in the intervention arm of the SWAT and 85.4% (n=123) in the control arm (Difference 3.1%, OR 1.29, 95% CI 0.71-2.33, p=0.41). There was also no evidence of a difference in the proportion of participants withdrawing from follow-up after contact (intervention n=7 (2.5%), control n=5 (3.5%); OR 0.76, 95% CI 0.23-2.44, p=0.64), nor in terms of proximity of 6-month visit completion to due date (HR 1.07, 95% CI 0.86-1.33, p=0.55).  Conclusion  It is unclear if contingent financial incentives increased rates of face-to-face follow-up completion within the SCIMITAR+ trial population. However, the sample size of this SWAT was constrained by the size of the host trial and power was limited. This SWAT adds to the body of evidence for initiatives to increase response rates in trials.",2019,Contingent financial incentives did not statistically significantly increase rates of face-to-face follow-up completion within the SCIMITAR+ trial population.,['434 participants'],"['contingent financial incentive', ""Trial' (SWAT) embedded within a host RCT (SCIMITAR""]","['CO breath measurement', 'proportion of participants completing a CO breath measurement', 'withdrawing from follow-up after contact and time from assessment due date to completion']",[],"[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2825543', 'cui_str': 'Estimated date of delivery'}]",434.0,0.270546,Contingent financial incentives did not statistically significantly increase rates of face-to-face follow-up completion within the SCIMITAR+ trial population.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coleman', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Peckham', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Bailey', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, York, YO10 5DD, UK.'}]",F1000Research,['10.12688/f1000research.21059.2']
1575,32739331,Which brand should be more nervous about nutritional information disclosure: McDonald's or Subway?,"This study examines the health halo and horn effects in the context of two fast food brands commonly associated with healthy and unhealthy food (i.e., Subway and McDonald's). Health halo is consumers' tendency to overestimate the healthiness of certain food categories or items based on a single claim, whereas health horn is the tendency to underestimate it. Specifically, we investigated the moderating effects of nutritional information disclosure and dietary restraint on consumers' behavioral intentions. Two items from the McDonald's and Subway menus each served as stimuli. They represented health halo confirmation (Roast Chicken sandwich) or disconfirmation (Italian Spicy sandwich) and health horn confirmation (Big Mac burger) or disconfirmation (McSpicy Cajun Burger). This study employed a 2 (nutritional information: present vs. absent) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) mixed factorial design. Participants were randomly assigned to one of two experimental conditions (nutritional information: present vs. absent) and presented with all four menu items. There was a decrease in behavioral intentions toward all menu items except the one representing health horn disconfirmation. In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich). The findings not only delineate the different practices companies adopt but also underscore the importance of nutritional information disclosure in helping consumers make healthier food choices.",2020,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[""consumers' behavioral intentions""]","[""absent)\u202f×\u202f4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters"", 'nutritional information disclosure and dietary restraint', ""health halo or horn associated with Subway or McDonald's menu items""]",['behavioral intentions'],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0019939', 'cui_str': 'Horns'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0524709', 'cui_str': 'Subways'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0167676,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[{'ForeName': 'Meeyoung', 'Initials': 'M', 'LastName': 'Joe', 'Affiliation': 'Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 505, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: cookie22@yonsei.ac.kr.'}, {'ForeName': 'Seoki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'School of Hospitality Management, The Pennsylvania State University, 217 Mateer Building University Park, PA, 16802, USA. Electronic address: leeseoki@psu.edu.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Ham', 'Affiliation': 'Dept. of Food & Nutrition, Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 510, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: sham2@yonsei.ac.kr.'}]",Appetite,['10.1016/j.appet.2020.104805']
1576,32739411,Apple polyphenol-rich drinks dose-dependently decrease early-phase postprandial glucose concentrations following a high-carbohydrate meal: a randomized controlled trial in healthy adults and in vitro studies.,"BACKGROUND


Previous research demonstrated that a high dose of phlorizin-rich apple extract (AE) can markedly inhibit early-phase postprandial glycemia, but efficacy of lower doses of the AE is unclear.
OBJECTIVE


To determine whether lower AE doses reduce early-phase postprandial glycemia in healthy adults and investigate mechanisms.
DESIGN


In a randomized, controlled, double-blinded, cross-over acute trial, drinks containing 1.8 g (HIGH), 1.35 g (MED), 0.9 g (LOW), or 0 g (CON) of a phlorizin-rich AE were consumed before 75 g starch/sucrose meal. Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations were measured 0-240 min, acetaminophen concentrations to assess gastric emptying rate, and 24 h urinary glucose excretion. Effects of AE on intestinal glucose transport were investigated in Caco-2/TC7 cells.
RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were -15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0) and -8.99 (-17.3, -0.7) mmol/L per minute for HIGH, MEDIUM and LOW respectively, delayed T max  (HIGH, MEDIUM and LOW 45 min vs. CON 30 min), but did not lower C max . Similar dose-dependent treatment effects were observed for insulin, C-peptide, and GIP. Gastric emptying rates and urinary glucose excretion did not differ. Serum phloretin, quercetin and epicatechin metabolites were detected postprandially. A HIGH physiological AE dose equivalent decreased total glucose uptake by 48% in Caco-2/TC7 cells.
CONCLUSIONS


Phlorizin-rich AE, even at a low dose, can slightly delay early-phase glycemia without affecting peak and total glycemic response.",2020,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)",['healthy adults'],"['Apple polyphenol-rich drinks', 'phlorizin-rich apple extract (AE', 'AE', 'phlorizin-rich AE were consumed before 75 g starch/sucrose meal']","['Postprandial blood glucose, insulin, C-peptide, glucose-dependent insulinotropic polypeptide (GIP) and polyphenol metabolites concentrations', 'gastric emptying rate, and 24 h urinary glucose excretion', 'total glucose uptake', 'Serum phloretin, quercetin and epicatechin metabolites', 'Gastric emptying rates and urinary glucose excretion', 'total glycaemic response', 'insulin, C-peptide, and GIP', 'early-phase postprandial glucose concentrations', 'plasma glucose iAUC', 'delayed T max  ', 'intestinal glucose transport']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0031562', 'cui_str': 'Phlorhizin'}, {'cui': 'C3257517', 'cui_str': 'Apple extract'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031560', 'cui_str': 'Phloretin'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}]",,0.233603,"RESULTS


AE significantly reduced plasma glucose iAUC 0-30 min at all doses: mean differences (95% CI) relative to CON were-15.6 (-23.3, -7.9), -11.3 (-19.6, -3.0)","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Prpa', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Corpe', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Atkinson', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Blackstone', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Leftley', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Parekh', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Philo', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich, UK.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Hall', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, Franklin-Wilkins Building, 150 Stamford Street, London, UK. Electronic address: wendy.hall@kcl.ac.uk.""}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2020.108466']
1577,32760093,Pain during pars plana vitrectomy following sub-Tenon versus peribulbar anesthesia: A randomized trial.,"PURPOSE


To compare pain during pars plana vitrectomy (PPV) following topical lidocaine jelly and sub-Tenon anesthesia versus peribulbar anesthesia.
METHODS


Prospective, single-center, randomized study. Patients scheduled for PPV for macular hole (MH) or epiretinal membrane (ERM) at the Retina and Vitreous Section of the Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo were randomly assigned to one of two groups in a 1:1 allocation ratio. Patients assigned to Group ST received topical anesthesia with 2% lidocaine jelly followed by sub-Tenon anesthesia with 2-4 ml of 1% ropivacaine. Patients assigned to PB received peribulbar anesthesia with 4-6 ml of 1% ropivacaine. After PPV, patients in both groups were asked to rate the level of pain they felt during the entire procedure (including anesthesia administration and PPV) by pointing at a 0-100 Visual Analogue Pain Scale (VAS). Data regarding demographics, patient characteristics and surgical features were also collected.
RESULTS


Fifty-four patients were enrolled in the study (26 in Group ST and 28 in Group PB). Baseline characteristics, including age, gender, and presence of comorbidities, were similar in both groups. The surgery performed was PPV alone in 10 and 14 patients in the ST and PB groups, respectively, and combined phacoemulsification and PPV in 16 and 14 patients in the ST and PB groups, respectively (p = 0.39, Pearson). Surgery duration (mean ± SD minutes) was similar in the two groups (62 ± 12 for ST and 70 ± 20 for PB, p = 0.09, t-Test). No patients needed supplemental topical or intravenous anesthesia during surgery. No sight- or life-threatening complication was observed in either group. VAS score was significantly lower in the ST compared to the PB group (median (interquartile range) was 1 (2.25-0) in the ST group compared to 11.5 (29.75-5) in the PB group, p< 0.0001, Wilcoxon).
CONCLUSION


In this study of patients who underwent PPV for MH or ERM, topical followed by sub-Tenon anesthesia was more effective in controlling pain during the whole vitrectomy procedure than peribulbar anesthesia. Compared to peribulbar anesthesia which is administered with a sharp needle, sub-Tenon anesthesia administered with a blunt cannula may be associated with a reduced risk of such adverse events as globe perforation, retrobulbar hemorrhage, and inadvertent injection of anesthesia into the optic nerve sheath.",2020,No sight- or life-threatening complication was observed in either group.,"['Fifty-four patients were enrolled in the study (26 in Group ST and 28 in Group PB', 'Patients scheduled for PPV for macular hole (MH) or epiretinal membrane (ERM) at the Retina and Vitreous Section of the Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo', 'patients who underwent PPV for MH or']","['pars plana vitrectomy following sub-Tenon versus peribulbar anesthesia', 'peribulbar anesthesia', 'ERM, topical followed by sub-Tenon anesthesia', 'pars plana vitrectomy (PPV', 'topical anesthesia with 2% lidocaine jelly followed by sub-Tenon anesthesia with 2-4 ml of 1% ropivacaine', 'peribulbar anesthesia with 4-6 ml of 1% ropivacaine', 'topical lidocaine jelly and sub-Tenon anesthesia']","['VAS score', 'sight- or life-threatening complication', 'Pain', 'Surgery duration (mean ± SD minutes', 'Visual Analogue Pain Scale (VAS']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439232', 'cui_str': 'min'}]",54.0,0.0335394,No sight- or life-threatening complication was observed in either group.,"[{'ForeName': 'Jefferson A S', 'Initials': 'JAS', 'LastName': 'Ribeiro', 'Affiliation': 'Superior School of Health Sciences, Amazonas State University, Manaus, AM, Brazil.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Department of Ophthalmology, Penn State College of Medicine, Hershey, Pennsylvania, United States of America.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Abrão', 'Affiliation': 'Department of Biomechanics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Jorge', 'Affiliation': 'Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0236624']
1578,32760144,A gender-sensitised weight-loss and healthy living program for men with overweight and obesity in Australian Football League settings (Aussie-FIT): A pilot randomised controlled trial.,"BACKGROUND


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


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


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


Australian New Zealand Clinical Trials Registry: ACTRN12617000515392.",2020,"MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.
","['men with overweight/obesity delivered in Australian Football League (AFL) settings', '426 men registered interest; 306 (72%) were eligible', '28 kg/m2), middle-aged (35-65 years old) men', 'men with overweight and obesity in Australian Football League settings (Aussie-FIT', 'Men were selected on a first-come first-served basis (n = 130; M age = 45.8, SD = 8; M BMI = 34.48 kg/m2, SD = 4.87', 'Participants were overweight/obese', 'Participants were recruited in May 2018, and the intervention took place between June and December 2018']","['MVPA', 'Aussie-FIT, a weight-loss program']","['weight loss (primary outcome) and recruitment and retention rates, self-reported measures (for example, psychological well-being), device-measured physical activity, waist size, and blood pressure', 'moderate-to-vigorous physical activity (MVPA', 'physical activity, decreased weight', 'adverse events']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.212539,"MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.
","[{'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Kwasnicka', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Hunt', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Gray', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Gucciardi', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Thøgersen-Ntoumani', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Olson', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kerr', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wyke', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Priority Research Centre in Physical Activity and Nutrition, School of Education, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Makate', 'Affiliation': 'School of Public Health, Curtin University, Perth, Australia.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Quested', 'Affiliation': 'Physical Activity and Well-being Research Group, Curtin University, Perth, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003136']
1579,32763533,Effects of aerobic exercise on cardiorespiratory fitness and social functioning in veterans 40 to 65 years old with schizophrenia.,"The usual physical activity level of people with chronic histories of schizophrenia is very low. In this pilot study, we examined the effects of an easy to implement aerobic exercise (AE) program on cardiorespiratory fitness and social functioning in 54 Veterans aged 40-65 years old with schizophrenia. Participants were randomized 2:1 to AE (36 forty-minute sessions conducted 3 times per week over 12 weeks) versus a non-aerobic stretching exercise condition conducted under the same regimen and timeframe. Cardiorespiratory fitness improved significantly within the AE group (p<.0001), and differed significantly from the comparison group (p<.02; Cohen's d=.41). Trend-level improvements were seen in social functioning within the AE group (p<.09) and showed a similar trend level difference in the between-group comparison (p<.06; Cohen's d=.35). Improvements in social functioning were significantly related to gains in cardiorespiratory fitness (r=.42; p<.01). AE effects on other physical and mental health indices were also examined. Overall, the AE intervention was well-tolerated, safe, and showed low rates of attrition after the commencement of training. Our findings indicate it is feasible to improve cardiorespiratory fitness in this clinical population, and there is suggestive evidence that the interventions aimed to do so may also benefit social functioning.",2020,"Overall, the AE intervention was well-tolerated, safe, and showed low rates of attrition after the commencement of training.","['people with chronic histories of schizophrenia', 'veterans 40 to 65 years old with schizophrenia', '54 Veterans aged 40-65 years old with schizophrenia']","['easy to implement aerobic exercise (AE) program', 'non-aerobic stretching exercise condition', 'aerobic exercise']","['social functioning', 'tolerated, safe', 'Cardiorespiratory fitness', 'cardiorespiratory fitness and social functioning', 'physical and mental health indices', 'cardiorespiratory fitness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0455502', 'cui_str': 'H/O: schizophrenia'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0299191,"Overall, the AE intervention was well-tolerated, safe, and showed low rates of attrition after the commencement of training.","[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kern', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, Los Angeles, California, United States of America; Department of Veterans Affairs Desert Pacific Mental Illness Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California, United States of America. Electronic address: rkern@ucla.edu.'}, {'ForeName': 'L Felice', 'Initials': 'LF', 'LastName': 'Reddy', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Cohen', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, Los Angeles, California, United States of America; Department of Veterans Affairs Desert Pacific Mental Illness Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California, United States of America.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Young', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, Los Angeles, California, United States of America; Department of Veterans Affairs Desert Pacific Mental Illness Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California, United States of America.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Green', 'Affiliation': 'UCLA Semel Institute for Neuroscience & Human Behavior, Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, Los Angeles, California, United States of America; Department of Veterans Affairs Desert Pacific Mental Illness Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California, United States of America.'}]",Psychiatry research,['10.1016/j.psychres.2020.113258']
1580,32763541,"Residual symptoms of PTSD following Sertraline plus enhanced medication management, Sertraline plus PE, and PE plus placebo.","Although prolonged exposure (PE) and SSRI antidepressants are effective in treating posttraumatic stress disorder (PTSD), previous studies have shown that some symptoms tend to persist. The current study compared sertraline hydrochloride plus enhanced medication management (EMM), PE plus placebo, or PE plus sertraline hydrochloride in the likelihood of each individual PTSD symptom persisting in veterans with a PTSD diagnosis. We compared the likelihood of individual PTSD symptoms persisting in those with versus without a PTSD diagnosis at posttreatment. We found no significant differences across conditions in which symptoms were likely to persist posttreatment. Among those without a PTSD diagnosis at posttreatment, sleeping difficulties (63.0%), hypervigilance (47.3%), and nightmares (45.0%) were most likely to persist. Findings indicate no consistent differences in residual symptoms between PE and medications, and shared decision making with patients is encouraged in selecting treatments. Gold standard treatments (e.g., CBT-I) may be warranted for residual symptoms like insomnia.",2020,"Among those without a PTSD diagnosis at posttreatment, sleeping difficulties (63.0%), hypervigilance (47.3%), and nightmares (45.0%) were most likely to persist.",['veterans with a PTSD diagnosis'],"['Sertraline', 'prolonged exposure (PE) and SSRI antidepressants', 'Sertraline plus PE, and PE plus placebo', 'sertraline hydrochloride plus enhanced medication management (EMM), PE plus placebo, or PE plus sertraline hydrochloride']","['sleeping difficulties', 'hypervigilance']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0600526', 'cui_str': 'Sertraline hydrochloride'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}]",,0.0425289,"Among those without a PTSD diagnosis at posttreatment, sleeping difficulties (63.0%), hypervigilance (47.3%), and nightmares (45.0%) were most likely to persist.","[{'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Tripp', 'Affiliation': 'VA San Diego Healthcare System, 3350 Villa La Jolla Drive, San Diego, CA 92161, USA; University of California, San Diego, School of Medicine, 9500 Gilman Drive, La Jolla, CA 92037, USA.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, 3350 Villa La Jolla Drive, San Diego, CA 92161, USA; University of California, San Diego, School of Medicine, 9500 Gilman Drive, La Jolla, CA 92037, USA; National Center for PTSD, 215 N. Main St., White River Junction, VT 05009, USA; VA Center of Excellence for Stress and Mental Health, 3350 La Jolla Village Dr., MC116B, San Diego, CA 92161, USA. Electronic address: snorman@health.ucsd.edu.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Consulting for Statistics, Computing and Analytics Research, University of Michigan, 915 E. Washington Street, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Venners', 'Affiliation': 'National Center for PTSD, Dissemination & Training Division, 795 Willow Road, Menlo Park, CA 94025, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Martis', 'Affiliation': 'VA San Diego Healthcare System, 3350 Villa La Jolla Drive, San Diego, CA 92161, USA; University of California, San Diego, School of Medicine, 9500 Gilman Drive, La Jolla, CA 92037, USA.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, One Bowdoin Square, Boston, MA, USA; Department of Psychiatry, New York University Grossman School of Medicine, One Park Avenue 8(th) Floor, New York, NY 10016, USA.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'VA San Diego Healthcare System, 3350 Villa La Jolla Drive, San Diego, CA 92161, USA; University of California, San Diego, School of Medicine, 9500 Gilman Drive, La Jolla, CA 92037, USA.'}, {'ForeName': 'Carolyn B', 'Initials': 'CB', 'LastName': 'Allard', 'Affiliation': 'VA San Diego Healthcare System, 3350 Villa La Jolla Drive, San Diego, CA 92161, USA; Alliant International University, 10455 Pomerado Road, San Diego, CA, USA.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Mental Health Service Line, Veterans Affairs Atlanta Healthcare System, 1670 Clairmont Rd., GA 30030, USA; Emory University School of Medicine, 12 Executive Park, 3(rd) Floor, Atlanta, GA 30329, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychiatry research,['10.1016/j.psychres.2020.113279']
1581,32770443,Intervention Delivery Matters: What Mothers at High Risk for Type 2 Diabetes Want in a Diabetes Prevention Program-Results from a Comparative Effectiveness Trial.,"Participants in the ENCOURAGE Healthy Families Study, a family-focused, modified Diabetes Prevention Program, reported challenges to and preferences for engaging in a diabetes prevention program. Challenges with flexible intervention delivery, accessibility, the traditional group-based format, and Coronavirus Disease 2019 (COVID-19) exposure risk can be mitigated by participant preferences for one-on-one, virtual/online intervention delivery.Trial Registration: ClinicalTrials.gov identifier, NCT01823367.",2020,"Participants in the ENCOURAGE Healthy Families Study, a family-focused, modified Diabetes Prevention Program, reported challenges to and preferences for engaging in a diabetes prevention program.",['Intervention Delivery Matters'],[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",[],[],,0.0293589,"Participants in the ENCOURAGE Healthy Families Study, a family-focused, modified Diabetes Prevention Program, reported challenges to and preferences for engaging in a diabetes prevention program.","[{'ForeName': 'Kelly N B', 'Initials': 'KNB', 'LastName': 'Palmer', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, USA. kpalmer1@arizona.edu.'}, {'ForeName': 'Valene E', 'Initials': 'VE', 'LastName': 'Garr Barry', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Marrero', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'Brett M', 'Initials': 'BM', 'LastName': 'McKinney', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Graves', 'Affiliation': 'YMCA of Greater Indianapolis, Indianapolis, USA.'}, {'ForeName': 'Chelsy K', 'Initials': 'CK', 'LastName': 'Winters', 'Affiliation': 'YMCA of Greater Indianapolis, Indianapolis, USA.'}, {'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00891-1']
1582,32735782,"Cannabidiol for the treatment of cannabis use disorder: a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial.","Background A substantial and unmet clinical need exists for pharmacological treatment of cannabis use disorders. Cannabidiol could offer a novel treatment, but it is unclear which doses might be efficacious or safe. Therefore, we aimed to identify efficacious doses and eliminate inefficacious doses in a phase 2a trial using an adaptive Bayesian design.
METHODS


We did a phase 2a, double-blind, placebo-controlled, randomised, adaptive Bayesian trial at the Clinical Psychopharmacology Unit (University College London, London, UK). We used an adaptive Bayesian dose-finding design to identify efficacious or inefficacious doses at a-priori interim and final analysis stages. Participants meeting cannabis use disorder criteria from DSM-5 were randomly assigned (1:1:1:1) in the first stage of the trial to 4-week treatment with three different doses of oral cannabidiol (200 mg, 400 mg, or 800 mg) or with matched placebo during a cessation attempt by use of a double-blinded block randomisation sequence. All participants received a brief psychological intervention of motivational interviewing. For the second stage of the trial, new participants were randomly assigned to placebo or doses deemed efficacious in the interim analysis. The primary objective was to identify the most efficacious dose of cannabidiol for reducing cannabis use. The primary endpoints were lower urinary 11-nor-9-carboxy-δ-9-tetrahydrocannabinol (THC-COOH):creatinine ratio, increased days per week with abstinence from cannabis during treatment, or both, evidenced by posterior probabilities that cannabidiol is better than placebo exceeding 0·9. All analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov (NCT02044809) and the EU Clinical Trials Register (2013-000361-36).
FINDINGS


Between May 28, 2014, and Aug 12, 2015 (first stage), 48 participants were randomly assigned to placebo (n=12) and to cannabidiol 200 mg (n=12), 400 mg (n=12), and 800 mg (n=12). At interim analysis, cannabidiol 200 mg was eliminated from the trial as an inefficacious dose. Between May 24, 2016, and Jan 12, 2017 (second stage), randomisation continued and an additional 34 participants were allocated (1:1:1) to cannabidiol 400 mg (n=12), cannabidiol 800 mg (n=11), and placebo (n=11). At final analysis, cannabidiol 400 mg and 800 mg exceeded primary endpoint criteria (0·9) for both primary outcomes. For urinary THC-COOH:creatinine ratio, the probability of being the most efficacious dose compared with placebo given the observed data was 0·9995 for cannabidiol 400 mg and 0·9965 for cannabidiol 800 mg. For days with abstinence from cannabis, the probability of being the most efficacious dose compared with placebo given the observed data was 0·9966 for cannabidiol 400 mg and 0·9247 for cannabidiol 800 mg. Compared with placebo, cannabidiol 400 mg decreased THC-COOH:creatinine ratio by -94·21 ng/mL (95% interval estimate -161·83 to -35·56) and increased abstinence from cannabis by 0·48 days per week (0·15 to 0·82). Compared with placebo, cannabidiol 800 mg decreased THC-COOH:creatinine ratio by -72·02 ng/mL (-135·47 to -19·52) and increased abstinence from cannabis by 0·27 days per week (-0·09 to 0·64). Cannabidiol was well tolerated, with no severe adverse events recorded, and 77 (94%) of 82 participants completed treatment.
INTERPRETATION


In the first randomised clinical trial of cannabidiol for cannabis use disorder, cannabidiol 400 mg and 800 mg were safe and more efficacious than placebo at reducing cannabis use.
FUNDING


Medical Research Council.",2020,"Cannabidiol was well tolerated, with no severe adverse events recorded, and 77 (94%) of 82 participants completed treatment.
","['48 participants', 'Participants meeting cannabis use disorder criteria from DSM-5', 'Between May 28, 2014, and Aug 12, 2015 (first stage']","['placebo', 'oral cannabidiol', 'placebo, cannabidiol', 'brief psychological intervention of motivational interviewing', 'cannabidiol 400 mg (n=12), cannabidiol 800 mg (n=11), and placebo']","['THC-COOH:creatinine ratio', 'lower urinary 11-nor-9-carboxy-δ-9-tetrahydrocannabinol (THC-COOH):creatinine ratio']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3844106', 'cui_str': '800'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",48.0,0.767603,"Cannabidiol was well tolerated, with no severe adverse events recorded, and 77 (94%) of 82 participants completed treatment.
","[{'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Freeman', 'Affiliation': ""Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath, UK; Clinical Psychopharmacology Unit, University College London, London, UK; Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, University College London, London, UK; National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. Electronic address: t.p.freeman@bath.ac.uk.""}, {'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Hindocha', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK; Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, University College London, London, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Baio', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Natacha D C', 'Initials': 'NDC', 'LastName': 'Shaban', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Thomas', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Danica', 'Initials': 'D', 'LastName': 'Astbury', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Freeman', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lees', 'Affiliation': 'Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': ""Addiction and Mental Health Group, Department of Psychology, University of Bath, Bath, UK; National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Morrison', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Michael A P', 'Initials': 'MAP', 'LastName': 'Bloomfield', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK; Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, University College London, London, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, UK; The Traumatic Stress Clinic, St Pancras Hospital, Camden and Islington National Health Service Foundation Trust, London, UK; Pain Management Centre, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': ""O'Ryan"", 'Affiliation': 'Substance Misuse Services, Camden and Islington National Health Service Foundation Trust, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kinghorn', 'Affiliation': 'Translational Research Office, School of Life and Medical Sciences, University College London, London, UK.'}, {'ForeName': 'Celia J A', 'Initials': 'CJA', 'LastName': 'Morgan', 'Affiliation': 'Psychopharmacology and Addiction Research Centre, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mofeez', 'Affiliation': 'Pain Management Centre, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK; National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, UK.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30290-X']
1583,32738409,Acute effects of adaptive Deep Brain Stimulation in Parkinson's disease.,"BACKGROUND


Beta-based adaptive Deep Brain Stimulation (aDBS) is effective in Parkinson's disease (PD), when assessed in the immediate post-implantation phase. However, the potential benefits of aDBS in patients with electrodes chronically implanted, in whom changes due to the microlesion effect have disappeared, are yet to be assessed.
METHODS


To determine the acute effectiveness and side-effect profile of aDBS in PD compared to conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation, 13 PD patients undergoing battery replacement were pseudo-randomised in a crossover fashion, into three conditions (NoStim, aDBS or cDBS), with a 2-min interval between them. Patient videos were blindly evaluated using a short version of the Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT).
RESULTS


Mean disease duration was 16 years, and the mean time since DBS-implantation was 6.9 years. subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p = .001), when compared to NoStim. Bradykinesia subscores were significantly lower in aDBS (p = .002), and did not achieve significance during cDBS (p = .08), when compared to NoStim. Two patients demonstrated re-emerging tremor during aDBS. SIT scores of patients who presented stimulation-induced dysarthria significantly worsened in cDBS (p = .009), but not in aDBS (p = .407), when compared to NoStim. Overall, stimulation was applied 48.8% of the time during aDBS.
CONCLUSION


Beta-based aDBS is effective in PD patients with bradykinetic phenotypes, delivers less stimulation than cDBS, and potentially has a more favourable speech side-effect profile. Patients with prominent tremor may require a modified adaptive strategy.",2020,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[""Parkinson's disease"", 'PD patients with bradykinetic phenotypes', '13 PD patients undergoing battery replacement', 'Patients with prominent tremor', ""Parkinson's disease (PD""]","['aDBS', 'Adaptive Deep Brain Stimulation', 'Beta-based aDBS', 'Beta-based adaptive Deep Brain Stimulation (aDBS', 'conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation']","['Mean disease duration', 'subUPDRS scores', 'SIT scores', ""Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT"", 'mean time since DBS-implantation', 'Bradykinesia subscores']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0445093', 'cui_str': 'No stimulation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}]",,0.0348207,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Piña-Fuentes', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands; Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom; Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'J Marc C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'van Zijl', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Harmen R', 'Initials': 'HR', 'LastName': 'Moes', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'van Laar', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'D L Marinus', 'Initials': 'DLM', 'LastName': 'Oterdoom', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Department of Movement Disorders and Neuromodulation, University of California San Francisco, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Beudel', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans. Electronic address: m.beudel@amsterdamumc.nl.'}]",Brain stimulation,['10.1016/j.brs.2020.07.016']
1584,32739466,Lavender and dodder combined herbal syrup versus citalopram in major depressive disorder with anxious distress: A double-blind randomized trial.,"BACKGROUND


Major depressive disorder (MDD) accompanied by anxious distress is a chronic and disabling disorder. Its conventional drug therapies often have low patient compliance due to drug-related side effects. In Persian medicine, lavender-dodder syrup is one formula often recommended for such disorders.
OBJECTIVE


This study compares the effects of lavender-dodder syrup to the standard drug, citalopram, for treating MDD with anxious distress.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION


This six-week, double-blind, randomized, clinical trial was carried out in a psychiatric outpatient clinic. During the six-week intervention period, patients in citalopram group received citalopram tablets 20 mg/d plus 5 mL placebo syrup every 12 h; patients in group B received placebo tablets once daily plus 5 mL of lavender-dodder herbal syrup every 12 h.
MAIN OUTCOME MEASURES


Primary outcome measures, depression and anxiety, were evaluated using the Hamilton Depression/Anxiety Rating Scales, and were scored at the beginning of the study and at weeks three and six. Secondary outcome measures including response to treatment and remission rates were also compared between the two groups.
RESULTS


Fifty-six participants with MDD and anxious distress were randomly assigned to two groups. Mean depression scores significantly decreased in citalopram and herbal groups at weeks three and six (time effect: P < 0.001), although the observed changes were not significantly different between the groups (intervention effect: P = 0.61). Mean anxiety scores were not significantly different between the two groups at week three (P = 0.75). However, at the end of week six, the observed decrease was significantly higher in the herbal syrup group than the citalopram group (intervention effect: P = 0.007).
CONCLUSION


The herbal syrup is an effective and tolerable supplement for treating MDD with anxious distress.
TRIAL REGISTRATION NUMBER


IRCT2016102430459N1 on Iranian Registry of Clinical Trials.",2020,"Mean depression scores significantly decreased in citalopram and herbal groups at weeks three and six (time effect: P < 0.001), although the observed changes were not significantly different between the groups (intervention effect: P = 0.61).","['major depressive disorder with anxious distress', 'Fifty-six participants with MDD and anxious distress', 'psychiatric outpatient clinic']","['Lavender and dodder combined herbal syrup versus citalopram', 'citalopram', 'placebo syrup', 'citalopram tablets 20\xa0mg', 'lavender-dodder syrup', 'placebo tablets once daily plus 5\xa0mL of lavender-dodder herbal syrup every 12\xa0h']","['Mean anxiety scores', 'Mean depression scores', 'response to treatment and remission rates', 'depression and anxiety', 'Hamilton Depression/Anxiety Rating Scales']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0996947', 'cui_str': 'Dodder'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1245573', 'cui_str': 'Citalopram Oral Tablet'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",56.0,0.364875,"Mean depression scores significantly decreased in citalopram and herbal groups at weeks three and six (time effect: P < 0.001), although the observed changes were not significantly different between the groups (intervention effect: P = 0.61).","[{'ForeName': 'Toktam Sadat', 'Initials': 'TS', 'LastName': 'Firoozeei', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran 1668753961, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Barekatain', 'Affiliation': 'Department of Psychiatry, School of Medicine, Isfahan University of Medical Sciences, Isfahan 8145831451, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Karimi', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran 1668753961, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Zargaran', 'Affiliation': 'Department of Traditional Pharmacy, School of Persian Medicine, Tehran University of Medical Sciences, Tehran 1668753961, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran 1449614353, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Rezaeizadeh', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran 1668753961, Iran. Electronic address: rezaeizadeh@sina.tums.ac.ir.'}]",Journal of integrative medicine,['10.1016/j.joim.2020.06.002']
1585,32739493,Patient-centered and efficacious advance care planning in cancer: Protocol and key design considerations for the PEACe-compare trial.,"BACKGROUND


Failure to deliver care near the end of life that reflects the needs, values and preferences of patients with advanced cancer remains a major shortcoming of our cancer care delivery system.
METHODS


A mixed-methods comparative effectiveness trial of in-person advance care planning (ACP) discussions versus web-based ACP is currently underway at oncology practices in Western Pennsylvania. Patients with advanced cancer and their caregivers are invited to enroll. Participants are randomized to either (1) in-person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool. The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs. Factors influencing ACP effectiveness are assessed via in-depth interviews with patients, caregivers and clinicians.
DISCUSSION


This trial will provide new and much-needed empirical evidence about two patient-facing ACP approaches that successfully overcome limitations of traditional written advance directives but entail very different investments of time and resources. It is innovative in using mixed methods to evaluate not only the comparative effectiveness of these approaches, but also the contexts and mechanisms influencing effectiveness. Data from this study will inform clinicians, payers and health systems seeking to adopt and scale the most effective and efficient ACP strategy in real-world oncology settings.",2020,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","['Patients with advanced cancer and their caregivers are invited to enroll', 'patients with advanced cancer']","['person advance care planning (ACP) discussions versus web-based ACP', 'person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool']","['patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs', 'ACP effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.133077,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","[{'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Resick', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: jmr58@pitt.edu.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: rabob@pitt.edu.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, USA; San Francisco Veterans Affairs Health Care System, SFVAMC 4150 Clement Street, #151R, San Francisco, CA 94121, USA. Electronic address: Rebecca.Sudore@ucsf.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'People Designs, Inc., 1304 Broad Street, Durham, NC 27705, USA. Electronic address: dfarrell@peopledesigns.com.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Belin', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: belin@pitt.edu.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Althouse', 'Affiliation': 'Center for Research on Health Care Data Center, University of Pittsburgh School of Medicine, 200 Meyran Avenue, Suite 300, Pittsburgh, PA 15213, USA. Electronic address: ada62@pitt.edu.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Ferrell', 'Affiliation': 'Division of Nursing Research and Education, Department of Population Sciences, City of Hope Medical Center, 1500 Duarte Road, Duarte, CA 91010, USA. Electronic address: BFerrell@coh.org.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Hammes', 'Affiliation': 'Respecting Choices, A Division of C-TAC Innovations, PO Box 258, Oregon, WI 53575-0258, USA. Electronic address: bhammes@respectingchoices.org.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology and Cancer Therapeutics Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: chue2@upmc.edu.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 600 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA 15213, USA. Electronic address: douglas.white@pitt.edu.'}, {'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Rak', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 3520 Fifth Ave, Suite100, Pittsburgh, PA 15213, USA. Electronic address: kjr8@pitt.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: yas28@pitt.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106071']
1586,32739611,Changes in technology acceptance among older people with dementia: the role of social robot engagement.,"OBJECTIVE


Emerging technologies such as social robots have shown to be effective in reducing loneliness and agitation for older people with dementia. However, the acceptance of technology (specifically social robots) was found to be low for older people with dementia. The current understanding of changes in technology acceptance following direct exposure is limited and lacks rigorous study design. This study examined the change in technology acceptance after a direct interaction with a humanoid social robot (Kabochan) that was deployed for long-term care facilities' residents with dementia.
METHODS


The technology acceptance was assessed using randomised control trials for a time frame of 32 weeks. A total of 103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong and were randomly allocated to either Kabochan-engagement group or control group. Participants in the engagement group interacted with Kabochan in an individual, non-facilitated approach. The behavioural engagement with Kabochan was observed by care workers and recorded into constructive engagement and non-engagement. Questionnaire surveys were taken placed at pre- and post-exposure with Kabochan to measure attitudes and beliefs towards technology. The questionnaire was based on previous studies on technology acceptance and included attitudes towards technology, perceived usefulness, perceived ease of use, technology self-efficacy, technology anxiety, and facilitating conditions.
RESULTS


Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group. Results further demonstrated that the magnitude of belief changes was related to the intensity of constructive behavioural engagement. Specifically, resident-robot behavioural engagement moderately improved attitudes towards technology (F = 11.62, p < 0.001, η p 2  = 0.11) and perceived usefulness (F = 5.75, p = 0.02, η p 2  = 0.06).
CONCLUSIONS


The study tentatively supports that exposure to Kabochan has potential for changing perceived ease of use but not for other beliefs and attitudes towards technology among long-term care residents with dementia. Direct engagement with a humanoid social robot might be promising in improving the perceived ease of use towards technology.",2020,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","['103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong', ""long-term care facilities' residents with dementia"", 'older people with dementia']","['humanoid social robot (Kabochan', 'humanoid social robot', 'Kabochan-engagement group or control group', 'Kabochan']","['Perceived ease of use', 'attitudes towards technology']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",103.0,0.0256322,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ke', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong. Electronic address: kechen@hku.hk.'}, {'ForeName': 'Vivian Wei-Qun', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong; Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: wlou@hku.hk.'}, {'ForeName': 'Kelvin Cheng-Kian', 'Initials': 'KC', 'LastName': 'Tan', 'Affiliation': 'Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: u3004055@connect.hku.hk.'}, {'ForeName': 'Man Yi', 'Initials': 'MY', 'LastName': 'Wai', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: gwai@skhwc.org.hk.'}, {'ForeName': 'Lai Lok', 'Initials': 'LL', 'LastName': 'Chan', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: llchan@skhwc.org.hk.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104241']
1587,32740288,Decline in Unintentional Lifting Velocity Is Both Load and Exercise Specific.,"Beck, M, Varner, W, LeVault, L, Boring, J, and Fahs, CA. Decline in unintentional lifting velocity is both load and exercise specific. J Strength Cond Res 34(10): 2709-2714, 2020-When monitoring the mean concentric velocity (MCV) for velocity-based resistance training, often a threshold in the decline in the MCV is used to regulate the number of repetitions performed. However, it is not clear if the decline in the MCV is affected by the type of exercise or the relative load used. Therefore, the purpose of this study was to compare the decline in the MCV between the overhead press (OHP) and deadlift (DL) during sets to fatigue at different loads. Thirty individuals (23 ± 3 years) with current training experience with both the OHP and DL completed a 1 repetition maximum (1RM) protocol for the OHP and DL. Subjects then returned to the laboratory on 2 separate occasions and completed 1 set of the OHP and DL to volitional fatigue at either 70 or 90% of their 1RM in a randomized order. The open barbell system measured the MCV of all repetitions. The absolute and relative (%) decline in the MCV was calculated for each condition and compared between loads (70 vs. 90% 1RM) and between lifts (OHP vs. DL). An alpha level of 0.05 was used at the criterion for statistical significance. The absolute decline in the MCV was greatest for the 70% OHP condition (0.36 ± 0.12 m·s) followed by 90% OHP (0.19 ± 0.10 m·s), 70% DL (0.16 ± 0.08 m·s), and 90% DL (0.09 ± 0.06 m·s); all were significantly different from one another (p < 0.05) except for 70% DL vs. 90% OHP (p = 0.441). There was a greater relative decline in the MCV for the OHP compared with the DL (50.1 ± 11.8% vs. 28.5 ± 11.8%; p < 0.001) and for 70% 1RM compared with 90% 1RM (44.5 ± 12.0% vs. 34.1 ± 12.0%; p < 0.001). These data suggest the decline in the MCV is both exercise and load specific. Applying a uniform velocity decline threshold for velocity-based training may reduce training volume to different extents depending on the exercise and relative load used.",2020,There was a greater relative decline in the MCV for the OHP compared with the DL (50.1 ± 11.8% vs. 28.5 ± 11.8%; p < 0.001) and for 70% 1RM compared with 90% 1RM (44.5 ± 12.0% vs. 34.1 ± 12.0%; p < 0.001).,['Thirty individuals (23 ± 3 years) with current training experience with both the OHP and DL completed a 1 repetition maximum (1RM) protocol for the OHP and DL'],['J Strength Cond Res XX(X'],"['overhead press (OHP) and deadlift (DL', 'Beck, M, Varner, W, LeVault, L, Boring, J, and Fahs, CA', 'mean concentric velocity (MCV']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C2945608', 'cui_str': 'Bore'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",,0.0284101,There was a greater relative decline in the MCV for the OHP compared with the DL (50.1 ± 11.8% vs. 28.5 ± 11.8%; p < 0.001) and for 70% 1RM compared with 90% 1RM (44.5 ± 12.0% vs. 34.1 ± 12.0%; p < 0.001).,"[{'ForeName': 'Maddison', 'Initials': 'M', 'LastName': 'Beck', 'Affiliation': 'Department of Exercise Science, Lindenwood University Belleville, Belleville, Illinois.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Varner', 'Affiliation': 'Department of Exercise Science, Lindenwood University Belleville, Belleville, Illinois.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'LeVault', 'Affiliation': 'Department of Exercise Science, Lindenwood University Belleville, Belleville, Illinois.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Boring', 'Affiliation': 'School of Health Sciences, Lindenwood University, St. Charles, Missouri.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Fahs', 'Affiliation': 'College of Health Sciences, Logan University, Chesterfield, Missouri.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003786']
1588,32740289,A 28-Day Carbohydrate-Restricted Diet Improves Markers of Cardiovascular Disease in Professional Firefighters.,"Waldman, HS, Smith, JW, Lamberth, J, Fountain, BJ, Bloomer, RJ, Butawan, MB, and McAllister, MJ. A 28-day carbohydrate-restricted diet improves markers of cardiovascular disease in professional firefighters. J Strength Cond Res 34(10): 2785-2792, 2020-This study compared the effects of a 4-week, nonketogenic, carbohydrate-restricted (<25% of calories) diet (CRD) on markers of inflammation and oxidative stress in professional firefighters (FF). Subjects (n = 15) reported to the laboratory for 2 sessions (i.e., baseline and post-CRD) where blood was drawn from an antecubital vein after a 10-hour overnight fast. Dependent variables measured at baseline and post-CRD included adiponectin, insulin, human growth hormone, cortisol, C-reactive protein, albumin, lipids, glucose, amylase, creatine kinase, malondialdehyde (MDA), advance oxidation protein products (AOPP), total nitrate + nitrite, and soluble intracellular adhesion molecule-1. Compared with baseline, the CRD resulted in dramatic improvements to subjects' cardiometabolic profiles, including decreases in AOPP (51.3 ± 27.3 vs. 32.9 ± 7.9 ng·ml), MDA (1.6 ± 0.6 vs. 1.1 ± 0.5 µmol·L), and triglycerides (84.4 ± 34.4 vs. 64.2 ± 14.4 mg·dl), respectively. In addition, the CRD increased total cholesterol (151.5 ± 23.0 vs. 167.7 ± 38.2 mg·dl) and high-density lipoprotein cholesterol (46.3 ± 12.7 vs. 50.6 ± 15.5 mg·dl), but no differences were found with low-density lipoprotein cholesterol. Overall, our results show a 4-week CRD can favorably improve some markers of cardiovascular health in male FF.",2020,"Compared with baseline, the CRD resulted in dramatic improvements to subjects' cardiometabolic profiles, including decreases in AOPP (51.3 ± 27.3 vs. 32.9 ± 7.9 ng·ml), MDA (1.6 ± 0.6 vs. 1.1 ± 0.5 µmol·L), and triglycerides (84.4 ± 34.4 vs. 64.2 ± 14.4 mg·dl), respectively.","['male FF', 'professional firefighters', 'professional firefighters (FF', 'Professional Firefighters']","['nonketogenic, carbohydrate-restricted (<25% of calories) diet (CRD', 'J Strength Cond Res XX(X', '28-Day Carbohydrate-Restricted Diet', 'carbohydrate-restricted diet']","['CRD increased total cholesterol', 'Waldman, HS, Smith, JW, Lamberth, J, Fountain, BJ, Bloomer, RJ, Butawan, MB, and McAllister, MJ', 'cardiovascular health', 'low-density lipoprotein cholesterol', 'high-density lipoprotein cholesterol', 'adiponectin, insulin, human growth hormone, cortisol, C-reactive protein, albumin, lipids, glucose, amylase, creatine kinase, malondialdehyde (MDA), advance oxidation protein products (AOPP), total nitrate + nitrite, and soluble intracellular adhesion molecule-1']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0453894', 'cui_str': 'Bloomers'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}]",,0.0871791,"Compared with baseline, the CRD resulted in dramatic improvements to subjects' cardiometabolic profiles, including decreases in AOPP (51.3 ± 27.3 vs. 32.9 ± 7.9 ng·ml), MDA (1.6 ± 0.6 vs. 1.1 ± 0.5 µmol·L), and triglycerides (84.4 ± 34.4 vs. 64.2 ± 14.4 mg·dl), respectively.","[{'ForeName': 'Hunter S', 'Initials': 'HS', 'LastName': 'Waldman', 'Affiliation': 'Department of Kinesiology, Human Performance Lab, University of North Alabama, Florence, Alabama.'}, {'ForeName': 'JohnEric W', 'Initials': 'JW', 'LastName': 'Smith', 'Affiliation': 'Department of Kinesiology, Applied Physiology Lab, Mississippi State University, Starkville, Mississippi.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lamberth', 'Affiliation': 'Department of Kinesiology, Applied Physiology Lab, Mississippi State University, Starkville, Mississippi.'}, {'ForeName': 'Brent J', 'Initials': 'BJ', 'LastName': 'Fountain', 'Affiliation': 'Department of Food Science, Nutrition, and Health Promotion, Mississippi State University, Starkville, Mississippi.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Bloomer', 'Affiliation': 'School of Health Studies, The University of Memphis, Memphis, Tennessee.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Butawan', 'Affiliation': 'School of Health Studies, The University of Memphis, Memphis, Tennessee.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McAllister', 'Affiliation': 'Department of Health and Human Performance, Metabolic & Applied Physiology Lab, Texas State University, San Marcos, Texas.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003749']
1589,32745732,Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization.,"BACKGROUND


Secondary preventive therapies play a key role in the prevention of adverse events after coronary artery bypass grafting (CABG). However, adherence to secondary preventive drugs after CABG is often poor. With the increasing penetration of smartphones, health-related smartphone applications might provide an opportunity to improve medication adherence. We aimed to evaluate the effectiveness and feasibility of using a smartphone-based application to improve medication adherence in patients after CABG.
METHODS


The Measurement and Improvement Studies of Surgical coronary revascularizatION: medication adherence (MISSION-2) study is a multicenter randomized controlled trial that planned to enroll over 1000 patients who underwent isolated CABG at one of four large teaching hospitals in China; all enrolled participants had access to a smartphone and were able to operate at least three smartphone applications. The investigators randomly assigned the participants to one of two groups: (1) the intervention group with an advanced smartphone application for 6 months which was designed specifically for this trial and did not exist before. Participants could receive medication reminders and cardiac health education by the smartphone application or (2) the control group with usual care. The primary outcome was CABG secondary preventive medication adherence as measured by the translated Chinese version of the 8-item Morisky Medication Adherence Scale (MMAS-8) at 6 months after randomization. The secondary outcomes were mortality, major adverse cardiovascular and cerebrovascular events (MACCE), cardiovascular rehospitalization, self-reported secondary preventive medication use after 6 months of follow-up, blood pressure (BP), body mass index (BMI), and self-reported smoking status. All analyses were conducted using the intention-to-treat principle.
RESULTS


A total of 1000 patients (mean age, 57.28 [SD, 9.09] years; 85.5% male) with coronary heart disease after CABG were enrolled between September 2015 and September 2016 and were randomly assigned to the intervention (n = 501) or control group (n = 499). At 6 months, the proportion of low-adherence participants, categorized by MMAS-8 scores, was 11.8% in the intervention group and 11.7% in the control group (RR = 1.005, 95% CI 0.682 to 1.480, P = 1.000). Similar results were found in sensitivity analyses that considered participants who withdrew from the study, or were lost to follow-up as nonadherent. There were no significant differences in the secondary clinical outcome measures, and there were no significant differences in the primary outcome across the subgroups tested. In the intervention group, the proportion of participants who used and operated the application during the first month after CABG was 88.1%; however, the use rate decreased sharply from 42.5% in the second month to 9.2% by the end of the study (6 months).
CONCLUSIONS


A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications. The limited room for improvement in medication adherence and the low participants' engagement with the smartphone applications might account for these non-significant outcomes.",2020,A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications.,"['patients after CABG', 'coronary artery bypass grafting (CABG', 'patients after surgical coronary revascularization', '1000 patients who underwent isolated CABG at one of four large teaching hospitals in China; all enrolled participants had access to a smartphone and were able to operate at least three smartphone applications', '1000 patients (mean age, 57.28 [SD, 9.09] years; 85.5% male) with coronary heart disease after CABG were enrolled between September 2015 and September 2016']","['Surgical coronary revascularizatION', 'smartphone-based application', 'Smartphone-based application', 'medication reminders and cardiac health education by the smartphone application or (2) the control group with usual care', 'intervention group with an advanced smartphone application']","['proportion of low-adherence participants, categorized by MMAS-8 scores', 'mortality, major adverse cardiovascular and cerebrovascular events (MACCE), cardiovascular rehospitalization, self-reported secondary preventive medication use after 6 months of follow-up, blood pressure (BP), body mass index (BMI), and self-reported smoking status', 'CABG secondary preventive medication adherence as measured by the translated Chinese version of the 8-item Morisky Medication Adherence Scale (MMAS-8', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1000.0,0.0677726,A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications.,"[{'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chongyang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Junzhe', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hanning', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Limeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Huishan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Tianjin, China.'}, {'ForeName': 'Chenfei', 'Initials': 'C', 'LastName': 'Rao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: raochenfeifuwai@126.com.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: zhengzhe@fuwai.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.06.019']
1590,32745733,"Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial).","BACKGROUND


Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk.
METHODS/DESIGN


The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life.
DISCUSSION


The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis.
TRIAL REGISTRATION


clinicaltrials.gov: NCT04160130.",2020,"The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk.","['440 patients across 35 sites in Europe', 'female than male patients', 'Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status', 'female patients with severe symptomatic aortic stenosis', 'women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk', 'female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA', 'women with severe symptomatic aortic stenosis']","['surgical aortic valve replacement (SAVR', 'transcatheter (TAVR', 'transcatheter heart valve replacement', 'TAVR with SAVR', 'TAVR']","['composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure', 'safety and efficacy', 'cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0182431', 'cui_str': 'Aortic valve prosthesis'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.159675,"The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk.","[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Eltchaninoff', 'Affiliation': 'Department of Cardiology, Rouen University Hospital, FHU REMOD-VHF, Rouen, France. Electronic address: helene.eltchaninoff@chu-rouen.fr.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Bonaros', 'Affiliation': 'Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: nikolaos.bonaros@tirol-kliniken.at.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Prendergast', 'Affiliation': ""St. Thomas' Hospital, London, United Kingdom. Electronic address: bernard.prendergast@gstt.nhs.uk.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Nietlispach', 'Affiliation': 'CardioVascularCenter, Hirslanden Klinik Im Park, Zurich, Switzerland. Electronic address: fabian.nietlispach@hirslanden.ch.'}, {'ForeName': 'Mariuca', 'Initials': 'M', 'LastName': 'Vasa-Nicotera', 'Affiliation': 'University Heart Center Frankfurt, Frankfurt, Germany. Electronic address: mariuca.vasa-nicotera@kgu.de.'}, {'ForeName': 'Alaide', 'Initials': 'A', 'LastName': 'Chieffo', 'Affiliation': 'Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: chieffo.alaide@hsr.it.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pibarot', 'Affiliation': 'Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, QC, Canada. Electronic address: philippe.pibarot@med.ulaval.ca.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bramlage', 'Affiliation': 'Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. Electronic address: peter.bramlage@ippmed.de.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Sykorova', 'Affiliation': 'Edwards Lifesciences, Prague, Czech Republic. Electronic address: lenka_sykorova@edwards.com.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kurucova', 'Affiliation': 'Edwards Lifesciences, Prague, Czech Republic. Electronic address: jana_kurucova@edwards.com.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: j.j.bax@lumc.nl.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: Stephan.Windecker@insel.ch.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: ndumonteil@clinique-pasteur.com.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: dtchetche@clinique-pasteur.com.'}]",American heart journal,['10.1016/j.ahj.2020.06.016']
1591,32745734,Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial.,"BACKGROUND


Gastrointestinal injury is a common complication in patients treated with antiplatelet agents after percutaneous coronary intervention (PCI). However, the effects of different antiplatelet regimens on the incidence and severity of gastrointestinal injury have not been well studied, principally due to the lack of a low-risk sensitive and accurate detection system.
TRIAL DESIGN


OPT-PEACE is a multicenter, randomized, double-blind, placebo-controlled trial. Gastrointestinal injury will be evaluated with the ANKON magnetically controlled capsule endoscopy system (AMCE), a minimally invasive approach for detecting mucosal lesions in the stomach, duodenum and small intestine. Patients without AMCE-detected gastrointestinal erosions, ulceration or bleeding after drug-eluting stent implantation are enrolled and treated with open-label aspirin (100 mg/d) plus clopidogrel (75 mg/d) for 6 months. Thereafter, 480 event-free patients will undergo repeat AMCE and are randomly assigned in a 1:1:1 ratio to receive aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo for an additional 6 months. A final AMCE is performed at 12 months. The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
CONCLUSIONS


OPT-PEACE is the first study to investigate the incidence and severity of gastrointestinal injury in patients receiving different antiplatelet therapy regimens after stent implantation. This trial will inform clinical decision-making for personalized antiplatelet therapy post-PCI.",2020,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","['480 event-free patients will undergo repeat AMCE', 'patients receiving different antiplatelet therapy regimens after stent implantation', 'patients treated with antiplatelet agents after percutaneous coronary intervention (PCI']","['aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo', 'open-label aspirin', 'clopidogrel', 'placebo']","['incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding', 'gastrointestinal erosions, ulceration or bleeding']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1261962', 'cui_str': 'Gastrointestinal erosion'}]",,0.524049,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Endoscopy, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Heyang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhaoshen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Mount Sinai Heart and the Cardiovascular Research Foundation, New York.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.06.004']
1592,32745768,Oxylipin regulation by phenolic compounds from coffee beverage: Positive outcomes from a randomized controlled trial in healthy adults and macrophage derived foam cells.,"Oxylipins are considered biomarkers related to cardiovascular diseases (CVDs). They are generated in vivo via the oxygenation of polyunsaturated fatty acids as a result of oxidative stress and inflammation. Oxylipins are involved in vascular functions and are produced during foam cell formation in atherogenesis. Additionally, the consumption coffee is associated with the regulation on a particular oxylipin group, the F 2t -isoprostanes (F 2t -IsoPs). This function has been attributed to the chlorogenic acids (CGAs) from the coffee beverage. Considering the anti-inflammatory and antioxidant properties of CGAs, we evaluated the effects of two types of coffee that provided 787 mg CGAs/day (Coffee A) and 407 mg CGAs/day (Coffee B) by reducing 35 selected oxylipins in healthy subjects. Furthermore, we assessed the effect of CGAs on the cellular proatherogenic response in foam cells by using an oxidized LDL (oxLDL)-macrophage interaction model. After eight weeks of coffee consumption, the contents of 12 urine oxylipins were reduced. However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs. Neither of the two coffees reduced the levels of oxLDL. Moreover, the in vitro oxylipin induction by oxLDL on foam cells was ameliorated by phenolic acids and CGAs, including the inhibition of IsoPs and PGs by caffeoylquinic and dicaffeoylquinic acids, respectively, while the phenolic acids maintained both antioxidant and anti-inflammatory activities. These findings suggest that coffee antioxidants are strong regulators of oxylipins related to CVDs. The clinical trial was registered on the International Clinical Trials Registry Platform, WHO primary registry (RPCEC00000168).",2020,"However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs.","['healthy adults and macrophage derived foam cells', 'healthy subjects']",['CGAs'],"['levels of oxLDL', 'IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0016390', 'cui_str': 'Foam cell'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0055633', 'cui_str': 'Chromogranin A'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0997851', 'cui_str': 'Geodia'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0588372,"However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs.","[{'ForeName': 'Oscar J', 'Initials': 'OJ', 'LastName': 'Lara-Guzmán', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Medina', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS (CSIC), P.O. Box 164, 30100 Campus University Espinardo, Murcia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Álvarez', 'Affiliation': 'Grupo de Investigación en Sustancias Bioactivas, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Oger', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Durand', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Galano', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Zuluaga', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Gil-Izquierdo', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS (CSIC), P.O. Box 164, 30100 Campus University Espinardo, Murcia, Spain. Electronic address: angelgil@cebas.csic.es.'}, {'ForeName': 'Katalina', 'Initials': 'K', 'LastName': 'Muñoz-Durango', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia. Electronic address: kmunoz@serviciosnutresa.com.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.07.020']
1593,32757065,Effect of carbohydrate-protein supplementation on endurance training adaptations.,"PURPOSE


To examine the influence of post-exercise protein feeding upon the adaptive response to endurance exercise training.
METHODS


In a randomised parallel group design, 25 healthy men and women completed 6 weeks of endurance exercise training by running on a treadmill for 30-60 min at 70-75% maximal oxygen uptake (VO 2max ) 4 times/week. Participants ingested 1.6 g per kilogram of body mass (g kg BM -1 ) of carbohydrate (CHO) or an isocaloric carbohydrate-protein solution (CHO-P; 0.8 g carbohydrate kg BM -1  + 0.8 g protein kg BM -1 ) immediately and 1 h post-exercise. Expired gas, blood and muscle biopsy samples were taken at baseline and follow-up.
RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 L min -1  and 3.0 ± 2 mL kg -1  min -1 , respectively). No change occurred in plasma albumin concentration from baseline to follow-up with CHO-P (4.18 ± 0.18 to 4.23 ± 0.17 g dL -1 ) or CHO (4.17 ± 0.17 to 4.12 ± 0.22 g dL -1 ; interaction: p > 0.05). Mechanistic target of rapamycin (mTOR) gene expression was up-regulated in CHO-P (+ 46%; p = 0.025) relative to CHO (+ 4%) following exercise training.
CONCLUSION


Post-exercise protein supplementation up-regulated the expression of mTOR in skeletal muscle over 6 weeks of endurance exercise training. However, the magnitude of improvement in VO 2max  was similar between groups.",2020,"RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 ",['25 healthy men and women completed 6\xa0weeks of'],"['endurance exercise training by running on a treadmill for 30-60\xa0min at 70-75% maximal oxygen uptake', 'endurance exercise training', 'carbohydrate (CHO', 'carbohydrate-protein supplementation', 'isocaloric carbohydrate-protein solution (CHO-P; 0.8\xa0g carbohydrate kg', 'L']","['BM -1', 'plasma albumin concentration', 'VO 2max', 'Mechanistic target of rapamycin (mTOR) gene expression', 'endurance training adaptations', 'Expired gas, blood and muscle biopsy samples']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0857876', 'cui_str': 'Plasma albumin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0587033', 'cui_str': 'Muscle biopsy sample'}]",25.0,0.046735,"RESULTS


Exercise training improved VO 2max  in both groups (p ≤ 0.001), but this increment was not different between groups either in absolute terms or relative to body mass (0.2 ± 0.2 ","[{'ForeName': 'Abdullah F', 'Initials': 'AF', 'LastName': 'Alghannam', 'Affiliation': 'Lifestyle and Health Research Center, Health Sciences Research Center, Princess Nourah Bint Abdulrahman University, Riyadh, 84428, Saudi Arabia. AFAlghannam@pnu.edu.sa.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Thomas', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dawid', 'Initials': 'D', 'LastName': 'Jedrzejewski', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lemon', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Byers', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Department of Life Sciences, University of Roehampton, London, SW15 4JD, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bilzon', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsintzas', 'Affiliation': ""School of Life Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04450-1']
1594,32771678,Gamma transcranial alternating current stimulation improves mood and cognition in patients with major depression.,"Major depression is one of the most common psychiatric disorders with a high rate of treatment resistance where new treatment options are urgently warranted. One of these new options are non-invasive brain stimulation techniques like transcranial magnetic or electric stimulation. One of the latter is transcranial Alternating Current Stimulation (tACS) in various frequencies. Here, we report a case series of six patients suffering from major depression treated with tACS in gamma (40 Hz) frequency. Patients were randomized to two groups, receiving either two 10-min stimulations (group 1) or a 20-min stimulation or per day (group 2) over ten days. Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2). Results also showed an improvement in cognitive functions assessed by word fluency and n-back test. It is hypothesized that gamma tACS could help to synchronize disturbed frequency bands in frontal and prefrontal cortex areas and thus restore dysbalanced neural connectivity in psychiatric disorders.",2020,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","['six patients suffering from major depression treated with tACS in gamma (40\xa0Hz) frequency', 'patients with major depression']","['Gamma transcranial alternating current stimulation', 'transcranial Alternating Current Stimulation (tACS', 'gamma tACS']","['Hamilton Depression Rating Scale and Beck Depression Inventory', 'cognitive functions assessed by word fluency and n-back test', 'mood and cognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0221377,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","[{'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Haller', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Senner', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Institute of Psychiatric Phenomics and Genomics (IPPG), Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department and Institute of Psychiatry, Laboratory of Neurosciences (LIM-27), University of Sao Paulo, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Palm', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Medical Park Chiemseeblick, Bernau, Felden, Germany. Electronic address: u.palm@medicalpark.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.009']
1595,32771909,Implementation science outcomes of a gender-focused HIV and alcohol risk-reduction intervention in usual-care settings in South Africa.,"BACKGROUND


South Africa has the highest HIV prevalence globally, which disproportionately affects women. Hazardous alcohol use reduces antiretroviral adherence which can lead to adverse health. Few evidence-based interventions addressing hazardous alcohol use and HIV have been implemented in real-world settings. This study aimed to evaluate implementation outcomes from the Women's Health CoOp (WHC)-an evidence-based gender-focused HIV intervention-which was implemented in Cape Town.
METHODS


We conducted this implementation science trial using a modified stepped-wedge design. Four health clinics were paired with four substance use rehabilitation programs and randomized into four cycles. Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle). We assessed adoption, acceptability, appropriateness, cost, and fidelity using a mixed methods approach.
RESULTS


Adoption: 100 % of staff trained in the WHC and designated as interventionists delivered one or more workshops. Acceptability: Interventionists found the WHC content beneficial to their patients and the WHC improved connections between clinical units in facilities. Appropriateness: The WHC aligned with facility goals to improve antiretroviral adherence and reduce alcohol use; however, there were implementation challenges, including staff shortages, stigma, and few places to refer women for supportive services. Cost: The cost of implementing the WHC was 20.59 ZAR (1.40 USD) per attendee. Fidelity: Interventionists implemented the WHC with high fidelity and quality.
CONCLUSIONS


The findings suggest it is feasible to integrate the WHC into usual-care settings. Future efforts to scale up the intervention will need to address social and structural implementation challenges.
TRIAL REGISTRATION


NCT02733003 approved 1/21/2016.",2020,Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle).,"[""Women's Health CoOp (WHC)-an evidence-based gender-focused HIV intervention-which was implemented in Cape Town"", 'usual-care settings in South Africa', 'Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle', 'Four health clinics']",['gender-focused HIV and alcohol risk-reduction intervention'],"['Acceptability', 'Fidelity', 'adoption, acceptability, appropriateness, cost, and fidelity', 'antiretroviral adherence', 'Cost', 'cost of implementing the WHC']","[{'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}]",,0.0625822,Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle).,"[{'ForeName': 'Margaret W', 'Initials': 'MW', 'LastName': 'Gichane', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Wendee M', 'Initials': 'WM', 'LastName': 'Wechsberg', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB #7445, Chapel Hill, NC, 27599, USA; Department of Psychology, North Carolina State University, 2310 Katharine Stinson Drive Raleigh, Raleigh, NC, 27607, USA; Psychiatry and Behavioral Sciences, Duke University School of Medicine, 40 Duke Medicine Circle, Durham, NC, 27710, USA. Electronic address: wmw@rti.org.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Ndirangu', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'Browne', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB #7445, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Courtney Peasant', 'Initials': 'CP', 'LastName': 'Bonner', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Grimwood', 'Affiliation': ""Kheth'Impilo AIDS Free Living, 11th Floor, Metlife Centre, 7 Walter Sisulu Avenue, Cape Town, 8000, South Africa.""}, {'ForeName': 'Najma', 'Initials': 'N', 'LastName': 'Shaikh', 'Affiliation': ""Kheth'Impilo AIDS Free Living, 11th Floor, Metlife Centre, 7 Walter Sisulu Avenue, Cape Town, 8000, South Africa.""}, {'ForeName': 'Brittni', 'Initials': 'B', 'LastName': 'Howard', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Zule', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108206']
1596,32777289,"Fixed-dose combination of three drugs, i.e. LABA/LAMA/ICS for COPD: Results of a real-world study from India.","BACKGROUND


The use of triple therapy with inhaled corticosteroids, long-acting beta-agonist and long-acting antimuscarinics has been shown to be beneficial in COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations. This study assessed the real-world effectiveness and safety of once-daily, fixed-dose combination of Tiotropium/Formoterol/Ciclesonide (TFC) (18 mcg/12 mcg/400 mcg) via dry powder inhaler (DPI) or metered dose inhaler (MDI) in patients with COPD.
PATIENTS AND METHODS


In this 24-week, open-label, prospective, non-comparative, multicentre, real-world study, COPD patients requiring triple therapy as judged by their physician, were enrolled. The primary endpoint was mean change from baseline in pre-dose Forced Expiratory Volume in 1 s (FEV 1 ) at week 24. Pre and post-dose (30 min) FEV 1 , Forced Vital capacity (FVC), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) score and safety were also evaluated. A post-hoc analysis was conducted to evaluate the efficacy of the triple drug combination among smoker and non-smoker COPD patients.
RESULTS


Out of the 297 patients enrolled [mean age 61 ± 10 years; 84.8% males; 55.2% smokers and post-dose FEV 1  (% predicted) 39 ± 16%], 253 completed the study. Mean change in pre-dose FEV 1  from baseline to week 24 increased significantly after administering the triple drug combination [580 ± 600 mL, 95% CI (510, 650 mL), p < 0.0001]. The increase in the pre-dose FEV 1  was significant at all time points (p < 0.0001). Similar improvements were seen in pre-dose FVC, post-dose FEV 1  and post-dose FVC across all time points. CAT scores and the proportion of patients with improved mMRC score improved at all visits. The post-hoc analysis showed that TFC significantly increased pre-dose FEV 1  both among smokers [mean change 200 ± 430 mL, 95% CI (130, 270 mL), p < 0.0001] as well as non-smokers [990 ± 470 mL, 95% CI (900, 1070 mL), p < 0.0001] at week 24. This difference was significant from week 12 onwards. Mean change in pre and post-dose FEV 1  and FVC was significant across all visits between the two groups. At week 24, CAT score reduced significantly from baseline (overall: -6.6 ± 6.07; smokers: -5.17 + 6.96; non-smokers: 8.06 ± 4.44; all p < 0.0001). The mean difference between the two groups was 2.88 (p < 0.0001) at week 24. TFC was well tolerated.
CONCLUSION


In this real world, multicentre study in India, TFC significantly improved lung function, symptoms and quality of life among all patients with COPD, but the effect was more pronounced among non-smoker COPD patients.",2020,The increase in the pre-dose FEV 1  was significant at all time points (p< 0.0001).,"['COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations', 'patients with COPD', 'smoker and non-smoker COPD patients', 'COPD patients requiring triple therapy as judged by their physician, were enrolled', '297 patients enrolled [mean age 61±10 years; 84.8% males; 55.2% smokers and post-dose']","['LABA/LAMA/ICS', 'TFC', 'Tiotropium/Formoterol/Ciclesonide (TFC']","['CAT score', 'tolerated', 'mMRC score', 'FEV 1 , Forced Vital capacity (FVC), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) score and safety', 'lung function, symptoms and quality of life', 'mean change from baseline in pre-dose Forced Expiratory Volume', 'CAT scores']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}]","[{'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0907850', 'cui_str': 'ciclesonide'}]","[{'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",297.0,0.141329,The increase in the pre-dose FEV 1  was significant at all time points (p< 0.0001).,"[{'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Salvi', 'Affiliation': 'Chest Research Foundation, Pune, India.'}, {'ForeName': 'Ashish Kumar', 'Initials': 'AK', 'LastName': 'Deb', 'Affiliation': 'Sudbhavana Hospital, Varanasi, India.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Om Surgical Center & Maternity Home, Varanasi, India.'}, {'ForeName': 'Venkateswara Reddy', 'Initials': 'VR', 'LastName': 'Tummuru', 'Affiliation': 'Eesha Multispeciality Hospital, Hyderabad, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Kodgule', 'Affiliation': 'Chest Research Foundation, Pune, India.'}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Hemalatha', 'Affiliation': 'Sree Narayana Institute of Medical Sciences, Ernakulam, India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Awasthi', 'Affiliation': 'Ajantha Hospitals & IVF Centre Pvt. Ltd., Lucknow, India.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Suraj', 'Affiliation': 'Institute of Chest Diseases, Kozhikode, India.'}, {'ForeName': 'Vinod Kumar', 'Initials': 'VK', 'LastName': 'Pavitran', 'Affiliation': 'KVM Multispeciality Hospital, Chirtihala, India.'}, {'ForeName': 'Shashi Prakash', 'Initials': 'SP', 'LastName': 'Mourya', 'Affiliation': 'Lal Hospital & Heart Centre, Lucknow, India.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': 'Madonna Hospital and Research Centre, Ernakulam, India.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': 'Cipla Ltd, Mumbai, India.'}, {'ForeName': 'Sushmeeta', 'Initials': 'S', 'LastName': 'Chhowala', 'Affiliation': 'Cipla Ltd, Mumbai, India. Electronic address: sushmeeta@cipla.com.'}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Gogtay', 'Affiliation': 'Cipla Ltd, Mumbai, India.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101932']
1597,32777381,Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.,"We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.",2020,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","['Latino patients', 'English and/or Spanish speaking self-identified adult Latino ED patients', 'Latino emergency department patients', 'unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD']","['automated bilingual computerized alcohol screening and brief intervention (AB-CASI', 'bilingual digital health tool']","['mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school', 'number of binge drinking days assessed using the 28-day timeline followback method']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.0627793,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","[{'ForeName': 'Federico E', 'Initials': 'FE', 'LastName': 'Vaca', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: federico.vaca@yale.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: james.dziura@yale.edu.'}, {'ForeName': 'Fuad', 'Initials': 'F', 'LastName': 'Abujarad', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: fuad.abujarad@yale.edu.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: michael.pantalon@yale.edu.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hsiao', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America; Yale School of Medicine, Department of Pediatrics, Section of Emergency Medicine, 100 York St, Suite 1F, New Haven, CT 06511, United States of America. Electronic address: allen.hsiao@yale.edu.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'University of Texas at El Paso, Latino Alcohol and Health Disparities Research Center (LAHDR), Psychology Building, Rooms 102 and 104, El Paso, TX 79968, United States of America. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': ""D'Onofrio"", 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: gail.donofrio@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106104']
1598,32773545,Influence of Resisted Sled-Pull Training on the Sprint Force-Velocity Profile of Male High-School Athletes.,"Cahill, MJ, Oliver, JL, Cronin, JB, Clark, K, Cross, MR, Lloyd, RS, and Lee, JE. Influence of resisted sled-pull training on the sprint force-velocity profile of male high-school athletes. J Strength Cond Res 34(10): 2751-2759, 2020-Although resisted sled towing is a commonly used method of sprint-specific training, little uniformity exists around training guidelines for practitioners. The aim of this study was to assess the effectiveness of unresisted and resisted sled-pull training across multiple loads. Fifty-three male high-school athletes were assigned to an unresisted (n = 12) or 1 of 3 resisted groups: light (n = 15), moderate (n = 14), and heavy (n = 12) corresponding to loads of 44 ± 4 %BM, 89 ± 8 %BM, and 133 ± 12 %BM that caused a 25, 50, and 75% velocity decrement in maximum sprint speed, respectively. All subjects performed 2 sled-pull training sessions twice weekly for 8 weeks. Split times of 5, 10, and 20 m improved across all resisted groups (d = 0.40-1.04, p < 0.01) but did not improve with unresisted sprinting. However, the magnitude of the gains increased most within the heavy group, with the greatest improvement observed over the first 10 m (d ≥ 1.04). Changes in preintervention to postintervention force-velocity profiles were specific to the loading prescribed during training. Specifically, F0 increased most in moderate to heavy groups (d = 1.08-1.19); Vmax significantly decreased in the heavy group but increased in the unresisted group (d = 012-0.44); whereas, Pmax increased across all resisted groups (d = 0.39-1.03). The results of this study suggest that the greatest gains in short distance sprint performance, especially initial acceleration, are achieved using much heavier sled loads than previously studied in young athletes.",2020,"Specifically, F0 increased most in moderate to heavy groups (d = 1.08-1.19); Vmax significantly decreased in the heavy group but increased in the unresisted group (d = 012-0.44); whereas, Pmax increased across all resisted groups (d = 0.39-1.03).","['young athletes', 'Fifty-three male high-school athletes', 'Male High-School Athletes', 'male high-school athletes']","['J Strength Cond Res XX(X', 'unresisted and resisted sled-pull training', 'resisted sled-pull training', 'Resisted Sled-Pull Training']","['Cahill, MJ, Oliver, JL, Cronin, JB, Clark, K, Cross, MR, Lloyd, RS, and Lee, JE', 'short distance sprint performance', 'Pmax']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",53.0,0.0160647,"Specifically, F0 increased most in moderate to heavy groups (d = 1.08-1.19); Vmax significantly decreased in the heavy group but increased in the unresisted group (d = 012-0.44); whereas, Pmax increased across all resisted groups (d = 0.39-1.03).","[{'ForeName': 'Micheál J', 'Initials': 'MJ', 'LastName': 'Cahill', 'Affiliation': 'Applied Health and Performance Department, Athlete Training and Health, Allen, Texas.'}, {'ForeName': 'Jon L', 'Initials': 'JL', 'LastName': 'Oliver', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Cronin', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': 'Department of Kinesiology, West Chester University, West Chester, Pennsylvania.'}, {'ForeName': 'Matt R', 'Initials': 'MR', 'LastName': 'Cross', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Rhodri S', 'Initials': 'RS', 'LastName': 'Lloyd', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Jeong E', 'Initials': 'JE', 'LastName': 'Lee', 'Affiliation': 'Department of Statistics, University of Auckland, Auckland, New Zealand.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003770']
1599,32773581,"The effect of aspirin on preeclampsia, intrauterine growth restriction and preterm delivery among healthy pregnancies with a history of preeclampsia.","BACKGROUND


Due to the significance of preeclampsia (PE) and its adverse outcomes in the health of both mother and newborn, the present study was carried out to investigate the effect of aspirin on preventing the occurrence of PE, intrauterine growth restriction (IUGR), and preterm delivery in women with a previous history of PE.
METHODS


The present clinical trial was conducted on 90 pregnant women with a previous history of PE referred to the Khalij Fars Hospital in Bandar Abbas, Hormozgan Province Iran from April 2017 to August 2018. The subjects of the study were randomly assigned into two groups of intervention and control to receive either 80 mg of aspirin or placebo daily during the pregnancy. Patients' information was obtained and recorded upon entering the study, follow-up visits, and childbirth.
RESULTS


Among participants who entered the clinical trial, 86 patients (95.6%) completed the study. During the pregnancy, systolic blood pressure increased by 8.25 ± 14.83 and 19.06 ± 18.33 mmHg in aspirin and placebo groups, respectively (p = 0.001). Also, the same happened with diastolic blood pressure (6.12 ± 11.46 vs 13.48 ± 13.95 mmHg, p = 0.010). The rate of PE was equal to 27 (62.8%) and 38 (88.4%) in the aspirin and placebo groups, respectively (aOR = 0.23, p = 0.013). In the aspirin group, the rate of IUGR was equal to 27.9% compared with 25.6% of newborns in the control group (aOR = 1.18, p = 0.750). Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p = 0.061).
CONCLUSION


The findings of the present study conducted exclusively on women with previous documented PE revealed that taking aspirin may have a preventive effect on PE in the current pregnancy.",2020,"Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p=0.061).
","['participants who entered the clinical trial, 86 patients (95.6%) completed the study', '90 pregnant women with a previous history of PE referred to the Khalij Fars Hospital in Bandar Abbas, Hormozgan Province Iran from April 2017 to August 2018', 'healthy pregnancies with a history of preeclampsia']","['intervention and control to receive either 80 mg of aspirin or placebo', 'aspirin', 'placebo']","['rate of IUGR', 'preeclampsia, intrauterine growth restriction and preterm delivery', 'rate of PE', 'systolic blood pressure', 'diastolic blood pressure', 'occurrence of PE, Intrauterine Growth Restriction (IUGR), and preterm delivery', 'rate of preterm delivery']","[{'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4076023', 'cui_str': 'History of pre-eclampsia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",90.0,0.0760191,"Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p=0.061).
","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Abdi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Afsane', 'Initials': 'A', 'LastName': 'Rozrokh', 'Affiliation': 'Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Zare', 'Affiliation': 'Epidemiology Department, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000400']
1600,32781050,"Systemic Inflammation, Vascular Function, and Endothelial Progenitor Cells after an Exercise Training Intervention in COPD.","BACKGROUND


Exercise training is a cornerstone of the treatment of chronic obstructive pulmonary disease (COPD) in all disease stages. Data about the training effects with supplemental oxygen in nonhypoxemic patients remains inconclusive. In this study we set out to investigate the training and oxygen effects on inflammatory markers, vascular function, and endothelial progenitor cells in this population of increased cardiovascular risk.
METHODS


In this prospective, randomized, double-blind, crossover study, 29 patients with nonhypoxemic COPD performed combined endurance and strength training 3 times a week while breathing medical air or supplemental oxygen for the first 6-week period, and were then reallocated to the opposite gas for the following 6 weeks. Exercise capacity, inflammatory biomarkers, endothelial function (peripheral arterial tone analysis), and endothelial progenitor cells were assessed. Data were also analyzed for a subgroup with endothelial dysfunction (reactive hyperemia index <1.67).
RESULTS


Following 12 weeks of exercise training, patients demonstrated a significant improvement of peak work rate and an associated decrease of blood fibrinogen and leptin. Eosinophils were found significantly reduced after exercise training in patients with endothelial dysfunction. In this subgroup, peripheral arterial tone analysis revealed a significant improvement of reactive hyperemia index. Generally, late endothelial progenitor cells were found significantly reduced after the exercise training intervention. Supplemental oxygen during training positively influenced the effect on exercise capacity without impact on inflammation and endothelial function.
CONCLUSIONS


This is the first randomized controlled trial in patients with COPD to show beneficial effects of exercise training not only on exercise capacity, but also on systemic/eosinophilic inflammation and endothelial dysfunction.",2020,"Following 12 weeks of exercise training, patients demonstrated a significant improvement of peak work rate and an associated decrease of blood fibrinogen and leptin.","['29 patients with non-hypoxemic COPD performed', 'patients with COPD', 'patients with endothelial dysfunction']","['combined endurance and strength training three times a week while breathing medical air or supplemental oxygen', 'Exercise Training Intervention', 'Exercise training', 'exercise training']","['inflammatory markers, vascular function and endothelial progenitor cells', 'Eosinophils', 'blood fibrinogen and leptin', 'peak work rate', 'Exercise capacity, inflammatory biomarkers, endothelial function (Peripheral Arterial Tone analysis) and endothelial progenitor cells', 'RHI', 'Systemic Inflammation, Vascular Function and Endothelial Progenitor Cells', 'systemic/eosinophilic inflammation and endothelial dysfunction', 'endothelial dysfunction (Reactive Hyperemia Index', 'late endothelial progenitor cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3536832', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0853182', 'cui_str': 'Blood fibrinogen'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3687252', 'cui_str': 'Eosinophilic inflammation'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",29.0,0.115684,"Following 12 weeks of exercise training, patients demonstrated a significant improvement of peak work rate and an associated decrease of blood fibrinogen and leptin.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Neunhäuserer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University of Salzburg, Austria; Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University of Salzburg, Austria; Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Patti', 'Affiliation': 'Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University of Salzburg, Austria; Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University of Salzburg, Austria; Division of Cardiology, University Heart Centre, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Kaiser', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University of Salzburg, Austria.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Cadamuro', 'Affiliation': 'Department of Laboratory Medicine, Paracelsus Medical University of Salzburg, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Lamprecht', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University of Salzburg, Austria; Department of Pulmonary Medicine, Faculty of Medicine, Kepler-University-Hospital, Johannes-Kepler-University, Linz, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ermolao', 'Affiliation': 'Sport and Exercise Medicine Division, Department of Medicine, University of Padova, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Studnicka', 'Affiliation': 'University Clinic of Pneumology, Paracelsus Medical University of Salzburg, Austria.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University of Salzburg, Austria; Research Institute for Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University of Salzburg, Austria. Electronic address: j.niebauer@salk.at.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.07.004']
1601,32788268,Early Feeding in Acute Pancreatitis in Children: A Randomized Controlled Trial.,"BACKGROUND


Studies have increasingly challenged the traditional management of acute pancreatitis (AP) with bowel rest. However, these studies used a low-fat diet or transgastric feeding and only included adults. Aiming to generate higher-quality prospective pediatric data, we compared the traditional approach of fasting and intravenous fluids and early enteral feeding with standard diet or formula.
METHODS


Randomized controlled trial of children (2-18 years) with mild-moderate AP. Patients were randomly assigned 1:1 to initial fasting and intravenous fluids or an immediate, unrestricted diet. Pain scores, blood measures, and cross-sectional imaging were recorded throughout admission and follow-up. The primary outcome was time to discharge, and secondary outcomes were clinical and biochemical resolution and local and systemic complication rates.
RESULTS


Of 33 patients (17 [52%] boys, mean age of 11.5 [±4.8] years), 18 (55%) were randomly assigned to early feeding and 15 (45%) were randomly assigned to initial fasting. We recorded the median (interquartile range [IQR]) time to discharge (2.6 [IQR 2.0 to 4.0] vs 2.9 [IQR 1.8 to 5.6];  P  = .95), reduction in serum lipase levels by day 2 (58% [IQR 2% to 85%] vs 48% [IQR 3% to 71%];  P  = .65), and readmission rates (1 of 18 [6%] vs 2 of 15 [13%];  P  = .22) between the early feeding and fasting cohorts, respectively. Immediate or delayed complication rates did not differ. Patients randomly assigned to early feeding had weight gain of 1.3 kg (IQR 0.29 to 3.6) at follow-up, compared with weight loss of 0.8 kg (IQR -2.1 to 0.7) in fasted patients ( P  = .028).
CONCLUSIONS


This is the first randomized controlled trial in pediatric AP. There was no difference between early commencement of a standard oral diet and initial fast in any of the major outcome measures.",2020,There was no difference between early commencement of a standard oral diet and initial fast in any of the major outcome measures.,"['Acute Pancreatitis in Children', '33 patients (17 [52%] boys, mean age of 11.5 [±4.8] years), 18 (55%) were randomly assigned to early feeding and 15 (45', 'children (2-18 years) with mild-moderate AP']","['fasting and intravenous fluids and early enteral feeding with standard diet or formula', 'initial fasting and intravenous fluids or an immediate, unrestricted diet']","['time to discharge, and secondary outcomes were clinical and biochemical resolution and local and systemic complication rates', 'median (interquartile range [IQR]) time to discharge', 'weight gain', 'Immediate or delayed complication rates', 'weight loss', 'readmission rates', 'Pain scores, blood measures, and cross-sectional imaging', 'serum lipase levels']","[{'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0428316', 'cui_str': 'Serum lipase measurement'}]",,0.140362,There was no difference between early commencement of a standard oral diet and initial fast in any of the major outcome measures.,"[{'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Ledder', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel; orenl@szmc.org.il.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Duvoisin', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Lekar', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Robert N', 'Initials': 'RN', 'LastName': 'Lopez', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Harveen', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Dehlsen', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Lev-Tzion', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Orlanski-Meyer', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Shteyer', 'Affiliation': 'Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Krishnan', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Lemberg', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': ""Department of Paediatric Gastroenterology, Dana-Dwek Children's Hospital, Tel Aviv, Israel; and.""}, {'ForeName': 'Chee Y', 'Initials': 'CY', 'LastName': 'Ooi', 'Affiliation': ""Department of Paediatric Gastroenterology, Sydney Children's Hospital, Sydney, Australia.""}]",Pediatrics,['10.1542/peds.2020-1149']
1602,32788281,Effect of 6 Months of Flash Glucose Monitoring in Youth With Type 1 Diabetes and High-Risk Glycemic Control: A Randomized Controlled Trial.,"OBJECTIVE


To investigate whether intermittently scanned continuous glucose monitoring (isCGM) significantly improves glycemic control compared with capillary self-monitored blood glucose (SMBG) in youth with type 1 diabetes and high-risk glycemic control.
RESEARCH DESIGN AND METHODS


This multicenter 6-month randomized, controlled, parallel-arm trial included 64 participants aged 13-20 years with established type 1 diabetes and glycated hemoglobin (HbA 1c ) ≥9% (≥75 mmol/mol). Participants were allocated to 6-month intervention (isCGM; FreeStyle Libre; Abbott Diabetes Care, Witney, U.K.) ( n  = 33) or control (SMBG;  n  = 31) using minimization. The primary outcome was the difference in change in HbA 1c  from baseline to 6 months.
RESULTS


There was no evidence of a difference between groups for changes in HbA 1c  at 6 months (adjusted mean 0.2% greater improvement for isCGM [95% CI -0.9 to 0.5] [-2.1 mmol/mol (95% CI -9.6 to 5.4)];  P  = 0.576). However, glucose-monitoring frequency was 2.83 (95% CI 1.72-4.65;  P  < 0.001) times higher in the isCGM group compared with that in the SMBG group at 6 months. The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months ( P  = 0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes specific) (all  P  > 0.1).
CONCLUSIONS


For youth with high-risk glycemic control, isCGM led to improvements in glucose testing frequency and diabetes treatment satisfaction. However, these did not translate to greater improvement in glycemic control over usual care with SMBG at 6 months.",2020,"The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months ( P  = 0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes specific) (all  P  > 0.1).
","['Youth With Type 1 Diabetes and High-Risk Control', 'youth with high-risk glycemic control', 'youth with type 1 diabetes and high-risk glycemic control', '64 participants aged 13-20 years with established type 1 diabetes and glycated hemoglobin (HbA 1c ) ≥9% (≥75 mmol/mol']","['intermittently scanned continuous glucose monitoring (isCGM', '6-month intervention (isCGM; FreeStyle Libre; Abbott Diabetes Care, Witney, U.K.) ( n  = 33) or control (SMBG;  n  = 31) using minimization', 'isCGM', 'SMBG', 'Flash Glucose Monitoring', 'capillary self-monitored blood glucose (SMBG']","['change in HbA 1c', 'Diabetes Treatment Satisfaction Questionnaire mean item score', 'glucose testing frequency and diabetes treatment satisfaction', 'glucose-monitoring frequency', 'glycemic control', 'fear of hypoglycemia and quality of life (both general and diabetes specific']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0595310', 'cui_str': 'Blood glucose testing kit'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",64.0,0.0891015,"The change in the Diabetes Treatment Satisfaction Questionnaire mean item score also favored isCGM at 6 months ( P  = 0.048), with no significant differences between groups for fear of hypoglycemia and quality of life (both general and diabetes specific) (all  P  > 0.1).
","[{'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Boucher', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Gray', 'Affiliation': 'Centre for Biostatistics, Division of Health Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Esko J', 'Initials': 'EJ', 'LastName': 'Wiltshire', 'Affiliation': 'Department of Paediatrics and Child Health, University of Otago, Wellington, Wellington, New Zealand.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'de Bock', 'Affiliation': 'Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Tomlinson', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Rayns', 'Affiliation': 'Endocrinology Department, Southern District Health Board, Dunedin, New Zealand.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'MacKenzie', 'Affiliation': 'Paediatric Department, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Chan', 'Affiliation': 'Department of Endocrinology and General Medicine, Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Wheeler', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand ben.wheeler@otago.ac.nz.""}]",Diabetes care,['10.2337/dc20-0613']
1603,32739045,Minimising haemodynamic lability during changeover of syringes infusing norepinephrine in adult critical care patients: a multicentre randomised controlled trial.,"BACKGROUND


Arterial pressure lability is common during the process of replacing syringes used for norepinephrine infusions in critically ill patients. It is unclear if there is an optimal approach to minimise arterial pressure instability during this procedures. We investigated whether 'double pumping' changeover (DPC) or automated changeover (AC) reduced blood pressure lability in critically ill adults compared with quick syringe changeover (QC).
METHODS


Patients requiring a norepinephrine infusion syringe change were randomised in a non-blinded trial undertaken in six ICUs. Randomisation was minimised by norepinephrine flow rate at inclusion and centre. The primary outcome was the frequency of increased/decreased mean arterial pressure (defined by </>15 mm Hg from baseline measurements) within 15 min of switching the syringe compared with QC.
RESULTS


Patients (mean age: 64 (range:18-88)) yr were randomly assigned to QC (n=95), DPC (n=95), or AC (n=96). Increased MAP was the commonest consequence of syringe changeovers. MAP variability was most frequent after DPC (89/224 changeovers; 39.7%) compared with 57/223 (25.6%) changeovers after quick syringe switch and 46/181 (25.4%) in patients randomised to receive automated changeover (P=0.001). Fewer events occurred with QC compared with DPC (P=0.002). Sensitivity analysis based on mixed models showed that performing several changeovers on a single patient had no impact. Both type of changeover and norepinephrine dose before syringe changeover were independently associated with MAP variations >15 mm Hg.
CONCLUSIONS


Quick changeover of norepinephrine syringes was associated with less blood pressure lability compared with DPC. The prevalence of MAP variations was the same between AC and QC.
CLINICAL TRIAL REGISTRATION


NCT02304939.",2020,MAP variability was most frequent after DPC (89/224 changeovers; 39.7%) compared with 57/223 (25.6%) changeovers after quick syringe switch and 46/181 (25.4%) in patients randomised to receive automated changeover (P=0.001).,"['critically ill adults', 'adult critical care patients', 'Patients requiring a', 'critically ill patients', 'Patients (mean age: 64 (range:18-88', 'n=95), DPC (n=95), or AC (n=96']","['norepinephrine infusion syringe', 'norepinephrine infusions', ""double pumping' changeover (DPC) or automated changeover (AC"", 'norepinephrine syringes', 'QC', 'norepinephrine', 'quick syringe changeover (QC']","['haemodynamic lability', 'frequency of increased/decreased mean arterial pressure', 'blood pressure lability', 'prevalence of MAP variations', 'MAP variability']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0520854', 'cui_str': 'Decreased mean arterial pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",,0.626804,MAP variability was most frequent after DPC (89/224 changeovers; 39.7%) compared with 57/223 (25.6%) changeovers after quick syringe switch and 46/181 (25.4%) in patients randomised to receive automated changeover (P=0.001).,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Poiroux', 'Affiliation': 'Medical Intensive Care Department, Angers University Hospital, Angers, France; UMR CNRS 6015-INSERM UI083 MitoVasc Institute, University of Angers, Angers, France. Electronic address: lapoiroux@chu-angers.fr.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Le Roy', 'Affiliation': 'Medical Intensive Care Department, Angers University Hospital, Angers, France.'}, {'ForeName': 'Anne-Sylvie', 'Initials': 'AS', 'LastName': 'Ramelet', 'Affiliation': 'Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne, Lausanne, Switzerland; Department Woman-Mother-Child, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Mélaine', 'Initials': 'M', 'LastName': 'Le Brazic', 'Affiliation': 'Medical Intensive Care Department, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Messager', 'Affiliation': 'Department of Anesthesiology and Critical Care, Critical Care Unit, Angers University Hospital, Angers, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Gressent', 'Affiliation': 'Medical Intensive Care Unit, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Yolaine', 'Initials': 'Y', 'LastName': 'Alcourt', 'Affiliation': 'Intensive Care Department, Vendée Regional Hospital, La Roche-sur-Yon, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Haubertin', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Critical Care Unit, University Teaching Hospital of Purpan, Toulouse, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Hamel', 'Affiliation': 'Department of Methodology and Biostatistics, Angers University Hospital, Angers, France.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Piquilloud', 'Affiliation': 'Medical Intensive Care Department, Angers University Hospital, Angers, France; Adult Intensive Care and Burn Unit, Lausanne University Hospital, University of Lausanne, Lausanne, Switzerland; UMR CNRS 6015-INSERM UI083 MitoVasc Institute, University of Angers, Angers, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Mercat', 'Affiliation': 'Medical Intensive Care Department, Angers University Hospital, Angers, France.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.06.041']
1604,32739049,"Safety, Pharmacokinetics, and Pharmacodynamics of the TLR4 Agonist GSK1795091 in Healthy Individuals: Results from a Randomized, Double-blind, Placebo-controlled, Ascending Dose Study.","PURPOSE


Interest in Toll-like receptor (TLR) agonists for cancer treatment has been renewed after promising preliminary clinical data in combination with checkpoint inhibitors. This first-in-human study assessed the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of intravenous GSK1795091, a synthetic TLR4 agonist, in healthy volunteers as a precursor to evaluation in patients with cancer.
METHODS


Healthy participants were randomized (1:3; double-blinded manner) to receive placebo or a single intravenous injection of GSK1795091 at doses of 7-100 ng. The primary objective was to evaluate the safety and tolerability of GSK1795091; secondary and exploratory objectives were to characterize GSK1795091 PK and PD properties.
FINDINGS


Forty participants received study treatment (10 received placebo and 30 received GSK1795091). Overall, 3 of the 10 participants (30%) who received placebo and 16 of the 30 (53%) who received GSK1795091 experienced ≥1 adverse event (AE). The most common AEs were influenza-like illness, headache, back pain, and increased body temperature. One participant experienced late-occurring AEs (alanine aminotransferase and aspartate aminotransferase increases), considered possibly related to GSK1795091. No serious AEs were reported. GSK1795091 PK properties were characterized by dose proportional increase in exposure. Transient and dose-dependent changes in induced cytokine and chemokine concentrations and immune cell counts were observed 1-4 h after GSK1795091 administration and returned to baseline within 24 h.
IMPLICATIONS


Intravenously administered GSK1795091 was acceptably tolerated in healthy volunteers, had favorable PK properties, and stimulated immune cell changes in a dose-dependent manner, providing evidence of target engagement and downstream pharmacology. These results supported the design and initiation of a repeat-dose study of intravenous GSK1795091 in combination with other immunotherapies in patients with advanced cancer. ClinicalTrials.gov identifier: NCT02798978.",2020,"Transient and dose-dependent changes in induced cytokine and chemokine concentrations and immune cell counts were observed 1-4 h after GSK1795091 administration and returned to baseline within 24 h.
","['patients with cancer', 'patients with advanced cancer', 'healthy volunteers', 'Forty participants received study treatment (10 received', 'Healthy Individuals', 'Healthy participants']","['GSK1795091', 'Placebo', 'placebo and 30 received GSK1795091', 'TLR4 Agonist GSK1795091', 'placebo']","['induced cytokine and chemokine concentrations and immune cell counts', 'safety and tolerability', 'late-occurring AEs (alanine aminotransferase and aspartate aminotransferase increases', 'influenza-like illness, headache, back pain, and increased body temperature', 'safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties', 'Safety, Pharmacokinetics, and Pharmacodynamics', 'adverse event (AE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0151904', 'cui_str': 'Aspartate aminotransferase increased'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.553993,"Transient and dose-dependent changes in induced cytokine and chemokine concentrations and immune cell counts were observed 1-4 h after GSK1795091 administration and returned to baseline within 24 h.
","[{'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Hug', 'Affiliation': 'R&D Pharmaceuticals, GSK, Upper Providence, PA, USA. Electronic address: bruce.a.hug@gsk.com.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Matheny', 'Affiliation': 'R&D Pharmaceuticals, GSK, Upper Providence, PA, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Burns', 'Affiliation': 'Global Clinical Sciences & Delivery, GSK, Abbotsford, Victoria, Australia.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Struemper', 'Affiliation': 'Clinical Pharmacology Modeling & Simulation, GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'R&D Pharmaceuticals, GSK, Upper Providence, PA, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Washburn', 'Affiliation': 'R&D Pharmaceuticals, GSK, Upper Providence, PA, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.022']
1605,32739072,The effectiveness of an oral hygiene program combined with health-promoting counseling for rural adults with cardiometabolic risks: A quasi-experimental design.,"AIM


The aim of this study was to explore the effectiveness of an oral hygiene program combined with home-phone health promoting counseling for rural adults with metabolic syndrome.
BACKGROUND


Metabolic syndrome is an important risk factor for cardiometabolic diseases. Evidence indicates that the poor oral hygiene and unhealthy lifestyles are closely related to metabolic syndrome.
METHODS


A prospective quasi-experimental design involved a total of 136 community adults, with metabolic syndrome living in two rural townships, were clustered and conveniently assigned to intervention and control group between June 2017 and December 2018. The primary outcome was the change in cardiometabolic biomarkers. The secondary outcome comprised changes in the health-promoting behaviors. The intervention effect was assessed using a generalized estimating equation model.
RESULTS


There were 80 and 56 participants in the intervention and control group, respectively. The mean age was 56 years and ranged from 33 to 70 years. The intervention group exhibited a greater improvement in body mass index (P < 0.01), waist circumference (P < 0.05), body fat percentage (P < 0.05), triglyceride level (P < 0.05), use of dental floss (P < 0.05), regular tooth scaling (P < 0.05), physical activity (P < 0.001), and total score of health-promoting behaviors (P < 0.001) than the control group.
CONCLUSION


This study supports the use of an oral hygiene program combined with home-phone counseling, which offers more advantages than its counterpart. Considering the global epidemic of cardiometabolic diseases, this is a community health nursing model worth to replicate and evaluate. Further study should consider innovative strategies to improve the awareness and adoption of a healthy lifestyle in residents with cardiometabolic risks.",2020,"The intervention group exhibited a greater improvement in body mass index (P < 0.01), waist circumference (P < 0.05), body fat percentage (P < 0.05), triglyceride level (P < 0.05), use of dental floss (P < 0.05), regular tooth scaling (P < 0.05), physical activity (P < 0.001), and total score of health-promoting behaviors (P < 0.001) than the control group.
","['rural adults with metabolic syndrome', '136 community adults, with metabolic syndrome living in two rural townships, were clustered and conveniently assigned to intervention and control group between June 2017 and December 2018', 'The mean age was 56\u202fyears and ranged from 33 to 70\u202fyears', 'residents with cardiometabolic risks', 'rural adults with cardiometabolic risks']","['oral hygiene program combined with health-promoting counseling', 'oral hygiene program combined with home-phone counseling', 'oral hygiene program combined with home-phone health promoting counseling']","['waist circumference', 'use of dental floss', 'body fat percentage', 'body mass index', 'triglyceride level', 'regular tooth scaling', 'physical activity', 'total score of health-promoting behaviors', 'change in cardiometabolic biomarkers', 'health-promoting behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0162350', 'cui_str': 'Dental floss'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0204173', 'cui_str': 'Scaling of tooth'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",136.0,0.0293092,"The intervention group exhibited a greater improvement in body mass index (P < 0.01), waist circumference (P < 0.05), body fat percentage (P < 0.05), triglyceride level (P < 0.05), use of dental floss (P < 0.05), regular tooth scaling (P < 0.05), physical activity (P < 0.001), and total score of health-promoting behaviors (P < 0.001) than the control group.
","[{'ForeName': 'Jui-Chu', 'Initials': 'JC', 'LastName': 'Huang', 'Affiliation': 'Department of Internal Medicine, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Ming-Shyan', 'Initials': 'MS', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiology, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Wen-Nan', 'Initials': 'WN', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Yunlin, Taiwan.'}, {'ForeName': 'Tung-Jung', 'Initials': 'TJ', 'LastName': 'Huang', 'Affiliation': 'Department of Internal Medicine, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Mei-Yen', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Chiayi, Taiwan; School of Nursing, Chang Gung University, Taoyuan, Taiwan; Department of Cardiology, Chang Gung Memorial Hospital, Chiayi, Taiwan. Electronic address: meiyen@mail.cgust.edu.tw.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151333']
1606,32739073,A quasi-experimental study of the effect of an intervention on older stroke survivors' functionality.,,2020,,"[""older stroke survivors' functionality""]",[],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",[],[],,0.0196864,,"[{'ForeName': 'Odete', 'Initials': 'O', 'LastName': 'Araújo', 'Affiliation': 'School of Nursing, University of Minho, Braga, Portugal; Health Sciences Research Unit, Nursing (UICISA E: UMinho), Portugal; Research Group ""Ageing C: Ageing Cluster"" - CINTESIS - Center for Health Technology and Services Research, Porto, Edifício da Biblioteca Geral (BGUM), Campus de Gualtar, 4710-057 Braga, Portugal. Electronic address: odete.araujo@ese.uminho.pt.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Lage', 'Affiliation': 'School of Nursing, University of Minho, Edifício da Biblioteca Geral (BGUM), Campus de Gualtar, 4710-057 Braga, Portugal. Electronic address: ilage@ese.uminho.pt.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cabrita', 'Affiliation': 'Faculty of Pharmacy, University of Lisbon, Avenida Professor Gama Pinto, 1649-003 Lisboa, Portugal. Electronic address: jcabrita@ff.ul.pt.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Teixeira', 'Affiliation': 'Institute of Biomedical Sciences Abel Salazar, University of Porto, Rua Jorge de Viterbo Ferreira 228, 4050-343 Porto, Portugal.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151280']
1607,32747361,"Afabicin, a First-in-Class Antistaphylococcal Antibiotic, in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Clinical Noninferiority to Vancomycin/Linezolid.","Afabicin (formerly Debio 1450, AFN-1720) is a prodrug of afabicin desphosphono, an enoyl-acyl carrier protein reductase (FabI) inhibitor, and is a first-in-class antibiotic with a novel mode of action to specifically target fatty acid synthesis in  Staphylococcus  spp. The efficacy, safety, and tolerability of afabicin were compared with those of vancomycin/linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI) due to staphylococci in this multicenter, parallel-group, double-blind, and double-dummy phase 2 study. Randomized patients (1:1:1) received either low-dose (LD) afabicin (intravenous [i.v.] 80 mg, followed by oral 120 mg, twice a day [BID]), high-dose (HD) afabicin (i.v. 160 mg, followed by oral 240 mg, BID), or vancomycin/linezolid (i.v. vancomycin 1 g or 15 mg/kg, followed by oral linezolid 600 mg, BID). The most frequent baseline pathogen was  Staphylococcus aureus  (97.5% of microbiological intent-to-treat [mITT] population), and 50.4% of patients had methicillin-resistant  S. aureus  Clinical response rates at 48 to 72 h postrandomization in the mITT population were comparable among treatment groups (94.6%, 90.1%, and 91.1%, respectively). Both LD and HD afabicin were noninferior to vancomycin/linezolid (differences, -3.5% [95% confidence interval {CI}, -10.8%, 3.9%] and 1.0% [95% CI, -7.3%, 9.2%], respectively). Most common treatment-emergent adverse events were mild and were headache (9.1% and 16.8%) and nausea (6.4% and 8.4%) with LD and HD afabicin, respectively. Afabicin was efficacious and well tolerated in the treatment of ABSSSI due to staphylococci, and these data support further development of afabicin for the treatment of ABSSSI and potentially other types of staphylococcal infections. (This study has been registered at ClinicalTrials.gov under identifier NCT02426918.).",2020,"Both LD and HD afabicin were non-inferior to vancomycin/linezolid (differences: -3.5%, 95% CI [-10.8%, 3.9%] and 1.0%, 95% CI [",[],"[' low dose (LD) afabicin ', 'Afabicin (formerly Debio 1450, AFN-1720', 'vancomycin/linezolid', 'vancomycin/linezolid (IV vancomycin', 'linezolid']","['headache', 'efficacy, safety and tolerability', 'nausea', 'methicillin-resistant  S. aureus  Clinical response rates']",[],"[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C4517603', 'cui_str': '1720'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0663241', 'cui_str': 'linezolid'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1955827', 'cui_str': 'Methicillin-Resistant'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0523739,"Both LD and HD afabicin were non-inferior to vancomycin/linezolid (differences: -3.5%, 95% CI [-10.8%, 3.9%] and 1.0%, 95% CI [","[{'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Wittke', 'Affiliation': 'Debiopharm International SA, Lausanne, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Vincent', 'Affiliation': 'Debiopharm International SA, Lausanne, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Southbay Pharma Research, Buena Park, California, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Heller', 'Affiliation': 'Long Beach Clinical Trials, Long Beach, California, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Kabler', 'Affiliation': 'Sunrise Hospital and Medical Center, Las Vegas, Nevada, USA.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Overcash', 'Affiliation': 'eStudySite, San Diego, California, USA.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Leylavergne', 'Affiliation': 'Debiopharm International SA, Lausanne, Switzerland.'}, {'ForeName': 'Guennaëlle', 'Initials': 'G', 'LastName': 'Dieppois', 'Affiliation': 'Debiopharm International SA, Lausanne, Switzerland guennaelle.dieppois@debiopharm.com.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00250-20']
1608,32747473,Reducing Antibiotic Prescribing in Primary Care for Respiratory Illness.,"BACKGROUND


One-third of outpatient antibiotic prescriptions for pediatric acute respiratory tract infections (ARTIs) are inappropriate. We evaluated a distance learning program's effectiveness for reducing outpatient antibiotic prescribing for ARTI visits.
METHODS


In this stepped-wedge clinical trial run from November 2015 to June 2018, we randomly assigned 19 pediatric practices belonging to the Pediatric Research in Office Settings Network or the NorthShore University HealthSystem to 4 wedges. Visits for acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infection for children 6 months to <11 years old without recent antibiotic use were included. Clinicians received the intervention as 3 program modules containing online tutorials and webinars on evidence-based communication strategies and antibioti c prescribing, booster video vignettes, and individualized antibiotic prescribing feedback reports over 11 months. The primary outcome was overall antibiotic prescribing rates for all ARTI visits. Mixed-effects logistic regression compared prescribing rates during each program module and a postintervention period to a baseline control period. Odds ratios were converted to adjusted rate ratios (aRRs) for interpretability.
RESULTS


Among 72 723 ARTI visits by 29 762 patients, intention-to-treat analyses revealed a 7% decrease in the probability of antibiotic prescribing for ARTI overall between the baseline and postintervention periods (aRR 0.93; 95% confidence interval [CI], 0.90-0.96). Second-line antibiotic prescribing decreased for streptococcal pharyngitis (aRR 0.66; 95% CI, 0.50-0.87) and sinusitis (aRR 0.59; 95% CI, 0.44-0.77) but not for acute otitis media (aRR 0.93; 95% CI, 0.83-1.03). Any antibiotic prescribing decreased for viral ARTIs (aRR 0.60; 95% CI, 0.51-0.70).
CONCLUSIONS


This program reduced antibiotic prescribing during outpatient ARTI visits; broader dissemination may be beneficial.",2020,"Any antibiotic prescribing decreased for viral ARTIs (aRR 0.60; 95% CI, 0.51-0.70).
","['children 6 months to <11 years old without recent antibiotic use were included', 'Primary Care for Respiratory Illness', 'November 2015 to June 2018, we randomly assigned 19 pediatric practices belonging to the Pediatric Research in Office Settings Network or the NorthShore University HealthSystem to 4 wedges']",[],"['acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infection', 'acute otitis media', 'sinusitis', 'streptococcal pharyngitis', 'viral ARTIs', 'probability of antibiotic prescribing for ARTI overall', 'overall antibiotic prescribing rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}]",[],"[{'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0001344', 'cui_str': 'Acute pharyngitis'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0036689', 'cui_str': 'Streptococcal sore throat'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",19.0,0.190718,"Any antibiotic prescribing decreased for viral ARTIs (aRR 0.60; 95% CI, 0.51-0.70).
","[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Kronman', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington; matthew.kronman@seattlechildrens.org.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gerber', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Grundmeier', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Communication, College of Liberal Arts and Sciences, Portland State University, Portland, Oregon.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Heritage', 'Affiliation': 'Department of Sociology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Stout', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Burges', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hedrick', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Warren', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Shalowitz', 'Affiliation': 'NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Shone', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois; and.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Steffes', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois; and.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Primary Care Research, American Academy of Pediatrics, Itasca, Illinois; and.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Fiks', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Mangione-Smith', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}]",Pediatrics,['10.1542/peds.2020-0038']
1609,32749579,Role of carbonated water technique to enhance Tc-99m tetrofosmin myocardial perfusion imaging by reducing subdiaphragmatic artefacts.,"OBJECTIVE


Myocardial perfusion imaging (MPI) with single-photon emission computed tomography (SPECT) is confounded by the extracardiac artefacts cause by hepatobiliary clearance of the radiotracers. Various techniques have been evaluated to lessen those artefacts. In this study, we endeavoured to determine the effect of carbonated water in reducing such infracardiac artefact so to improve MPI image quality, sensitivity and specificity.
METHODS


A total of 1000 patients were prospectively enrolled and randomised into two equal groups as A and B. Group A were given 250 ml of carbonated beverages and Group B were given 250 ml plain water immediately after radiotracer injection. Images were evaluated qualitatively and quantitatively for the interfering extracardiac artefacts.
RESULTS


The qualitative analysis favoured carbonated water in reducing the interfering intestinal activity during rest as well as stress (p = 0.005 and p < 0.001, respectively). Quantitative calculation showed significant improvement of myocardium to extracardiac ratio with carbonated water ingestion in rest (p = 0.031) and vasodilator stress studies (p = 0.004). However, for exercise stress studies quantitative evaluation were not statistically different between the two protocols (p = 0.855).
CONCLUSION


Carbonated water ingestion is an easy and effective way to enhance SPECT image quality by mitigating extracardiac artefacts.",2020,"However, for exercise stress studies quantitative evaluation were not statistically different between the two protocols (p = 0.855).
",['A total of 1000 patients'],"['carbonated water technique', '250\xa0ml of carbonated beverages and Group B', 'carbonated', 'Myocardial perfusion imaging (MPI) with single-photon emission computed tomography (SPECT']","['MPI image quality, sensitivity and specificity', 'interfering intestinal activity', 'vasodilator stress studies']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3494193', 'cui_str': 'Soda Water'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0007025', 'cui_str': 'Carbonated drink'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0007026', 'cui_str': 'Carbonate'}, {'cui': 'C2350390', 'cui_str': 'Myocardial Perfusion Imaging'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}]","[{'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042402', 'cui_str': 'Vasodilator agent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",1000.0,0.0302971,"However, for exercise stress studies quantitative evaluation were not statistically different between the two protocols (p = 0.855).
","[{'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Department of Cardiology, National Institute of Cardiovascular Disease, Rafiqui (H.J) Shaheed Road, Karachi, Pakistan. sabahussain23@gmail.com.'}, {'ForeName': 'Fateh Ali Tipoo', 'Initials': 'FAT', 'LastName': 'Sultan', 'Affiliation': 'Cardiology Section, Department of Medicine, Aga Khan University Hospital, Karachi, Pakistan.'}]",Annals of nuclear medicine,['10.1007/s12149-020-01504-4']
1610,32745085,"Anopheles bionomics, insecticide resistance and malaria transmission in southwest Burkina Faso: A pre-intervention study.","BACKGROUND


Twenty-seven villages were selected in southwest Burkina Faso to implement new vector control strategies in addition to long lasting insecticidal nets (LLINs) through a Randomized Controlled Trial (RCT). We conducted entomological surveys in the villages during the dry cold season (January 2017), dry hot season (March 2017) and rainy season (June 2017) to describe malaria vectors bionomics, insecticide resistance and transmission prior to this trial.
METHODS


We carried out hourly catches (from 17:00 to 09:00) inside and outside 4 houses in each village using the Human Landing Catch technique. Mosquitoes were identified using morphological taxonomic keys. Specimens belonging to the Anopheles gambiae complex and Anopheles funestus group were identified using molecular techniques as well as detection of Plasmodium falciparum infection and insecticide resistance target-site mutations.
RESULTS


Eight Anopheles species were detected in the area. Anopheles funestus s.s was the main vector during the dry cold season. It was replaced by Anopheles coluzzii during the dry hot season whereas An. coluzzii and An. gambiae s.s. were the dominant species during the rainy season. Species composition of the Anopheles population varied significantly among seasons. All insecticide resistance mechanisms (kdr-w, kdr-e and ace-1 target site mutations) investigated were found in each members of the An. gambiae complex but at different frequencies. We observed early and late biting phenotypes in the main malaria vector species. Entomological inoculation rates were 2.61, 2.67 and 11.25 infected bites per human per month during dry cold season, dry hot season and rainy season, respectively.
CONCLUSION


The entomological indicators of malaria transmission were high despite the universal coverage with LLINs. We detected early and late biting phenotypes in the main malaria vector species as well as physiological insecticide resistance mechanisms. These data will be used to evaluate the impact of complementary tools to LLINs in an upcoming RCT.",2020,"Entomological inoculation rates were 2.61, 2.67 and 11.25 infected bites per human per month during dry cold season, dry hot season and rainy season, respectively.
","['Twenty-seven villages', 'villages during the dry cold season (January 2017), dry hot season (March 2017) and rainy season (June 2017) to describe malaria vectors bionomics, insecticide resistance and transmission prior to this trial', 'southwest Burkina Faso']",[],['Entomological inoculation rates'],"[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0005550', 'cui_str': 'Bionomics'}, {'cui': 'C0021575', 'cui_str': 'Insecticide Resistance'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}]",[],"[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]",27.0,0.022626,"Entomological inoculation rates were 2.61, 2.67 and 11.25 infected bites per human per month during dry cold season, dry hot season and rainy season, respectively.
","[{'ForeName': 'Dieudonné Diloma', 'Initials': 'DD', 'LastName': 'Soma', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Barnabas Mahugnon', 'Initials': 'BM', 'LastName': 'Zogo', 'Affiliation': 'MIVEGEC, Université de Montpellier, CNRS, IRD, Montpellier, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Somé', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': ""Bertin N'Cho"", 'Initials': 'BN', 'LastName': 'Tchiekoi', 'Affiliation': 'MIVEGEC, Université de Montpellier, CNRS, IRD, Montpellier, France.'}, {'ForeName': 'Domonbabele François de Sales', 'Initials': 'DFS', 'LastName': 'Hien', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Hermann Sié', 'Initials': 'HS', 'LastName': 'Pooda', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Sanata', 'Initials': 'S', 'LastName': 'Coulibaly', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Jacques Edounou', 'Initials': 'JE', 'LastName': 'Gnambani', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ouari', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Mouline', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Dahounto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Georges Anicet', 'Initials': 'GA', 'LastName': 'Ouédraogo', 'Affiliation': 'Université Nazi Boni, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Fournet', 'Affiliation': 'MIVEGEC, Université de Montpellier, CNRS, IRD, Montpellier, France.'}, {'ForeName': 'Alphonsine Amanan', 'Initials': 'AA', 'LastName': 'Koffi', 'Affiliation': ""Institut Pierre Richet (IPR), Bouaké, Côte d'Ivoire.""}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Pennetier', 'Affiliation': 'MIVEGEC, Université de Montpellier, CNRS, IRD, Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Moiroux', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Roch Kounbobr', 'Initials': 'RK', 'LastName': 'Dabiré', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}]",PloS one,['10.1371/journal.pone.0236920']
1611,32745092,Aspirin versus low-molecular-weight heparin for venous thromboembolism prophylaxis in orthopaedic trauma patients: A patient-centered randomized controlled trial.,"BACKGROUND


Emerging evidence suggests aspirin may be an effective venous thromboembolism (VTE) prophylaxis for orthopaedic trauma patients, with fewer bleeding complications. We used a patient-centered weighted composite outcome to globally evaluate aspirin versus low-molecular-weight heparin (LMWH) for VTE prevention in fracture patients.
METHODS


We conducted an open-label randomized clinical trial of adult patients admitted to an academic trauma center with an operative extremity fracture, or a pelvis or acetabular fracture. Patients were randomized to receive LMWH (enoxaparin 30-mg) twice daily (n = 164) or aspirin 81-mg twice daily (n = 165). The primary outcome was a composite endpoint of bleeding complications, deep surgical site infection, deep vein thrombosis, pulmonary embolism, and death within 90 days of injury. A Global Rank test and weighted time to event analysis were used to determine the probability of treatment superiority for LMWH, given a 9% patient preference margin for oral administration over skin injections.
RESULTS


Overall, 18 different combinations of outcomes were experienced by patients in the study. Ninety-nine patients in the aspirin group (59.9%) and 98 patients in the LMWH group (59.4%) were event-free within 90 days of injury. Using a Global Rank test, the LMWH had a 50.4% (95% CI, 47.7-53.2%, p = 0.73) probability of treatment superiority over aspirin. In the time to event analysis, LMWH had a 60.5% probability of treatment superiority over aspirin with considerable uncertainty (95% CI, 24.3-88.0%, p = 0.59).
CONCLUSION


The findings of the Global Rank test suggest no evidence of superiority between LMWH or aspirin for VTE prevention in fracture patients. LMWH demonstrated a 60.5% VTE prevention benefit in the weighted time to event analysis. However, this difference did not reach statistical significance and was similar to the elicited patient preferences for aspirin.",2020,The findings of the Global Rank test suggest no evidence of superiority between LMWH or aspirin for VTE prevention in fracture patients.,"['orthopaedic trauma patients', 'adult patients admitted to an academic trauma center with an operative extremity fracture, or a pelvis or acetabular fracture', 'fracture patients']","['LMWH', 'aspirin versus low-molecular-weight heparin (LMWH', 'LMWH or aspirin', 'Aspirin versus low-molecular-weight heparin', 'aspirin', 'LMWH (enoxaparin']","['composite endpoint of bleeding complications, deep surgical site infection, deep vein thrombosis, pulmonary embolism, and death within 90 days of injury']","[{'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0347804', 'cui_str': 'Fracture of acetabulum'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",99.0,0.246285,The findings of the Global Rank test suggest no evidence of superiority between LMWH or aspirin for VTE prevention in fracture patients.,"[{'ForeName': 'Bryce E', 'Initials': 'BE', 'LastName': 'Haac', 'Affiliation': 'Department of Surgery, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Orthopaedics, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Theodore T', 'Initials': 'TT', 'LastName': 'Manson', 'Affiliation': 'Department of Orthopaedics, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Renan C', 'Initials': 'RC', 'LastName': 'Castillo', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Orthopaedics, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Stein', 'Affiliation': 'Department of Surgery, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0235628']
1612,32745891,Automatic Imitation in Comorbid PTSD & Alcohol Use Disorder and Controls: an RCT of Intranasal Oxytocin.,"INTRODUCTION


Mimicking movements of others makes both the imitating and imitated partners feel closer. Oxytocin may increase focus on others and has been shown to increase automatic imitation in healthy controls (HC). However, this has not been replicated, and oxytocin's effects on automatic imitation have not been demonstrated in clinical populations. This study attempts to replicate effects on HC and examine effects on people with comorbid posttraumatic stress disorder and alcohol use disorder (PTSD-AUD).
METHODS


Fifty-four males with PTSD-AUD and 43 male HC received three intranasal treatment conditions (placebo, oxytocin 20 International Units (IU), and oxytocin 40 IU) in a randomized order, across three separate testing days, as part of a double-blind, crossover parent study. At 135 min post-administration, each performed the imitation-inhibition task, which quantifies automatic imitation as the congruency effect (CE). After exclusions, the final analyzed data set included 49 participants with PTSD-AUD and 38 HC.
RESULTS


In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase. In PTSD-AUD, oxytocin did not significantly increase CE. Post-hoc analysis showed the PTSD-AUD group had higher CE than HC on placebo visits.
DISCUSSION


Our data suggest PTSD-AUD is associated with higher automatic imitation than HC in the absence of oxytocin administration. We successfully replicated findings that oxytocin increases automatic imitation in HC. This demonstrates an unconscious motor effect induced by oxytocin, likely relevant to more complex forms of imitative movements, which have the potential to improve social connection. We did not find a significant effect of oxytocin on automatic imitation in PTSD-AUD. Future research should examine imitation in both sexes, at peak oxytocin levels, and on increasingly complex forms of imitation.",2020,"In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase.","['49 participants with PTSD-AUD and 38 HC', 'Fifty-four males with PTSD-AUD and 43 male HC', 'people with comorbid posttraumatic stress disorder and alcohol use disorder (PTSD-AUD', 'healthy controls (HC']","['intranasal treatment conditions (placebo, oxytocin 20 International Units (IU), and oxytocin 40 IU', 'oxytocin', 'Intranasal Oxytocin', 'Oxytocin']","['CE', 'automatic imitation']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0439453', 'cui_str': 'IU'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]",49.0,0.0522705,"In HC, oxytocin 20 IU demonstrated a statistically significant increase in CE, and 40 IU showed a trend-level increase.","[{'ForeName': 'Tyler E', 'Initials': 'TE', 'LastName': 'Morrison', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA. Electronic address: morrisont@gmail.com.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: lize.decoster@gmail.com.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Stauffer', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Christopher.Stauffer@ucsf.edu.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: jin.wen2100@gmail.com.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Ahmadi', 'Affiliation': 'VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: elnaz.ahmadi@gmail.com.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Delucchi', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA. Electronic address: Kevin.Delucchi@ucsf.edu.'}, {'ForeName': 'Aoife', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Aoife.ODonovan@ucsf.edu.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry at University of California San Francisco School of Medicine, 401 Parnassus Ave (Box 0984 RTP), San Francisco, CA, 94143, USA; VA San Francisco Healthcare System, 4150 Clement St (116C-1), San Francisco, CA, 94121, USA. Electronic address: Josh.Woolley@ucsf.edu.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104787']
1613,32754804,Efficacy of GAD-alum immunotherapy associated with HLA-DR3-DQ2 in recently diagnosed type 1 diabetes.,"AIMS/HYPOTHESIS


The aim of this study was to determine if retention of C-peptide following immunotherapy using recombinant GAD65 conjugated to aluminium hydroxide (GAD-alum) is influenced by HLA risk haplotypes DR3-DQ2 and DR4-DQ8.
METHODS


HLA-dependent treatment effect of GAD-alum therapy on C-peptide retention in individuals with recent-onset type 1 diabetes was evaluated using individual-level patient data from three placebo-controlled, randomised clinical trials using a mixed repeated measures model.
RESULTS


A significant and dose-dependent effect was observed in individuals positive for the genotypes that include HLA-DR3-DQ2 but not HLA-DR4-DQ8 and in the broader subgroup of individuals positive for all genotypes that include HLA-DR3-DQ2 (i.e. including those also positive for HLA-DR4-DQ8). Higher doses (three or four injections) showed a treatment effect ratio of 1.596 (95% CI 1.132, 2.249; adjusted p = 0.0035) and 1.441 (95% CI 1.188, 1.749; adjusted p = 0.0007) vs placebo for the two respective HLA subgroups.
CONCLUSIONS/INTERPRETATION


GAD65-specific immunotherapy has a significant effect on C-peptide retention in individuals with recent-onset type 1 diabetes who have the DR3-DQ2 haplotype. Graphical abstract.",2020,"Higher doses (three or four injections) showed a treatment effect ratio of 1.596 (95% CI 1.132, 2.249; adjusted p = 0.0035) and 1.441 (95% CI 1.188, 1.749; adjusted p = 0.0007) vs placebo for the two respective HLA subgroups.
","['individuals with recent-onset type 1 diabetes who have the DR3-DQ2 haplotype', 'individuals with recent-onset type 1 diabetes']","['placebo', 'recombinant GAD65 conjugated to aluminium hydroxide (GAD-alum', 'GAD-alum therapy', 'GAD-alum immunotherapy']",['HLA-DR3-DQ2'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0019772', 'cui_str': 'HLA-DR3 antigen'}]",,0.276531,"Higher doses (three or four injections) showed a treatment effect ratio of 1.596 (95% CI 1.132, 2.249; adjusted p = 0.0035) and 1.441 (95% CI 1.188, 1.749; adjusted p = 0.0007) vs placebo for the two respective HLA subgroups.
","[{'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Hannelius', 'Affiliation': 'Diamyd Medical AB, Kungsgatan 29, 111 56, Stockholm, Sweden. ulf.hannelius@diamyd.com.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Beam', 'Affiliation': 'Department of Biomedical Sciences, Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Ludvigsson', 'Affiliation': ""Crown Princess Victoria Children's Hospital, Linköping, Sweden. Johnny.Ludvigsson@liu.se.""}]",Diabetologia,['10.1007/s00125-020-05227-z']
1614,32750063,Family nurture intervention in the NICU increases autonomic regulation in mothers and children at 4-5 years of age: Follow-up results from a randomized controlled trial.,"BACKGROUND


Maturation of multiple neurobehavioral systems, including autonomic regulation, is altered by preterm birth. The purpose of this study was to determine the long-term effects of Family Nurture Intervention (FNI) in the NICU on autonomic regulation of preterm infants and their mothers.
METHOD


A subset of infants and mothers (48% of infants, 51% of mothers) randomly assigned to either standard are (SC), or SC plus the FNI in the NICU in a prior RCT (ClincalTrials.gov; NCT01439269) returned for follow-up assessments when the children were 4 to 5 years corrected age (CA). ECGs were collected for 10 minutes in mothers and their children while children were in their mothers' laps. Heart rate, standard deviation for heart rate, respiratory sinus arrhythmia (RSA)-an index of parasympathetic regulation, and a measure of vagal efficiency were quantified.
RESULTS


Both children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031). In addition, RSA increased more rapidly in FNI children between infancy and the 4 to 5-year follow-up time point (SC = +3.11±0.16 loge msec2, +3.67±0.19 loge msec2 for FNI, p<0.05). These results show that the rate of increase in RSA from infancy to childhood is more rapid in FNI subjects.
CONCLUSION


Although these preliminary follow-up results are based on approximately half of subjects originally enrolled in the RCT, they suggest that FNI-NICU led to healthier autonomic regulation in both mother and child, when measured during a brief face-to-face socioemotional interaction. A Pavlovian autonomic co-conditioning mechanism may underly these findings that can be exploited therapeutically.",2020,"Both children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031).","['mothers and children at 4-5 years of age', 'preterm infants and their mothers']","['RSA', 'Family nurture intervention', 'Family Nurture Intervention (FNI', 'NICU']","['Heart rate, standard deviation for heart rate, respiratory sinus arrhythmia (RSA)-an index of parasympathetic regulation, and a measure of vagal efficiency', 'autonomic regulation', 'levels of RSA', 'RSA']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0640867,"Both children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031).","[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Welch', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Barone', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Porges', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Amie A', 'Initials': 'AA', 'LastName': 'Hane', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Katie Y', 'Initials': 'KY', 'LastName': 'Kwon', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ludwig', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Raymond I', 'Initials': 'RI', 'LastName': 'Stark', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Surman', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kolacz', 'Affiliation': 'Traumatic Stress Research Consortium, Kinsey Institute, Indiana University, Bloomington, IN, United States of America.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Myers', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY, United States of America.'}]",PloS one,['10.1371/journal.pone.0236930']
1615,31611625,The relative importance of factors predicting outcome for myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial.,"Disease factors such as tumor burden and molecular risk affect myeloma patient outcomes as well as patient factors that impact the capacity to deliver treatment. How the relative importance of these factors changes with patient age has not previously been investigated comprehensively. We analyzed data from 3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI. Even with novel therapeutic approaches progression-free survival (PFS) and overall survival (OS) are affected by age with a stepwise reduction in PFS and OS with each decade increase. Renal function deteriorated with increasing age whilst the frequency of t(4;14) and del(17p) decreased and gain(1q) increased. The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group. Molecular events have a larger effect on outcome in younger patients with their relative contribution diminishing in the elderly. Performance status is important for patient outcome at all ages suggesting that physical frailty may be a more important predictor of outcome than age itself. Significant differences in the factors driving patient outcomes at different ages are important to consider as we design disease segmentation strategies to deliver personalized treatment approaches.",2020,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","['myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial', 'younger patients with their relative contribution diminishing in the elderly', '3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI']",[],"['relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0547204,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research, London, UK. charlotte.pawlyn@icr.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Striha', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Vallari', 'Initials': 'V', 'LastName': 'Shah', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': ""Haematological Malignancy Diagnostic Service (HMDS), St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Section of Experimental Haematology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}]",Leukemia,['10.1038/s41375-019-0595-5']
1616,32756878,Dorsolateral prefrontal cortex response to negative tweets relates to executive functioning.,"Cognitive performance can become impaired when a stimulus evokes an emotional response. Social media often elicits emotional reactions, but, despite social media's ubiquity, cognitive and neural consequences of exposure to negative online content are relatively unknown. Fifty-seven human adults (18-29 years; 38 female) who identified with at least one historically-marginalized group performed a novel 'Tweet Task'. While undergoing functional magnetic resonance imaging, participants completed a spatial reasoning task before and after reading a set of actual tweets. Participants were randomly assigned to read negative, discriminatory tweets from President Trump (Negative Condition) or neutral tweets (Neutral Condition). Participants in the Negative Condition reported worsening affect and demonstrated performance interference post-tweet compared to those in the Neutral Condition. Affect post-tweet was associated with parametric reductions in left dorsolateral prefrontal cortex, which predicted variance in performance beyond elicited negative affect. Performance effects were demonstrated on an unrelated spatial reasoning task suggesting that engaging with negative, emotionally-arousing content on social media can have deleterious effects on executive functioning in non-social domains.",2020,Participants in the Negative Condition reported worsening affect and demonstrated performance interference post-tweet compared to those in the Neutral Condition.,"[""Fifty-seven human adults (18-29\xa0years; 38 female) who identified with at least one historically-marginalized group performed a novel 'Tweet Task""]","['functional magnetic resonance imaging', 'read negative, discriminatory tweets from President Trump (Negative Condition) or neutral tweets (Neutral Condition']","['Performance effects', 'Cognitive performance']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}]",57.0,0.0229807,Participants in the Negative Condition reported worsening affect and demonstrated performance interference post-tweet compared to those in the Neutral Condition.,"[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Tashjian', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Galván', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA 90095, USA.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa101']
1617,32757418,The efficacy of administrating a sweet-tasting solution for reducing the pain related to dental injections in children: A randomized controlled trial.,"BACKGROUND


Anaesthetic injections are an unpleasant experience for children in the dental office. Oral intake of sweet substances by newborns has been shown to be effective in reducing pain.
AIM


The purpose of this study was to determine whether a prior administration of a sweet-tasting solution has an effect on dental injection pain.
DESIGN


A total of 56 healthy children needing bilateral maxillary primary canine extraction were included in this split-mouth randomized clinical trial. In the test side, dental injection (local infiltration) was applied after the patient received a sweet-tasting solution, while in the control side sterile water was administered. The patients' demographic characteristics, body mass index (BMI), and sweet taste preference were recorded. Pain perception during injection was measured using visual analogue scale (VAS) and sound, eye, body movement (SEM).
RESULTS


Mean VAS (28.30 ± 6.43) and SEM (2.14 ± 0.78) in the test side were lower than the control side (45.80 ± 7.17 and 2.95 ± 1.00). It was shown that higher BMI was associated with reduction in the analgesic effect, while the individual's tendency to sweetness increased pain reduction.
CONCLUSIONS


Sweet taste administration before dental injections in children helps to control the associated pain. This effect is influenced by the individual's sweet taste tendency and BMI.",2020,"It was shown that higher BMI was associated with reduction in the analgesic effect while the individual's tendency to sweetness increased pain reduction.
","['children in the dental office', '60 healthy children needing bilateral maxillary primary canine extraction', 'children']","['sweet tasting solution', 'sweet-tasting solution']","['pain reduction', 'Pain perception', 'visual analogue scale (VAS) and sound, eye, body movement (SEM', 'demographic characteristics, body mass index (BMI) and sweet taste preference', 'Mean VAS ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011386', 'cui_str': 'Dental Office'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",60.0,0.181686,"It was shown that higher BMI was associated with reduction in the analgesic effect while the individual's tendency to sweetness increased pain reduction.
","[{'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Shiraz University of Medical Science, Shiraz, Fars, Iran.'}, {'ForeName': 'Mahboobe', 'Initials': 'M', 'LastName': 'Ahmadbeigi', 'Affiliation': 'School of Dentistry, Shaherkord University of Medical Sciences, Shahrekord, Chaharmahal Bakhtiari, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Vossoughi', 'Affiliation': 'Oral and Dental Disease Research Center, Department of Dental Public Health, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Fars, Iran.'}, {'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Sardarian', 'Affiliation': 'Orthodontic Research Center, Department of Orthodontics, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Fars, Iran.'}]",International journal of paediatric dentistry,['10.1111/ipd.12697']
1618,32785213,Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults.,"In March 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 1 , a pandemic. With rapidly accumulating numbers of cases and deaths reported globally 2 , a vaccine is urgently needed. Here we report the available safety, tolerability and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.gov identifier NCT04368728) among 45 healthy adults (18-55 years of age), who were randomized to receive 2 doses-separated by 21 days-of 10 μg, 30 μg or 100 μg of BNT162b1. BNT162b1 is a lipid-nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes the trimerized receptor-binding domain (RBD) of the spike glycoprotein of SARS-CoV-2. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 μg was not administered because of the increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared with the 30-μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second dose. Geometric mean neutralizing titres reached 1.9-4.6-fold that of a panel of COVID-19 convalescent human sera, which were obtained at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate.",2020,RBD-binding IgG concentrations and SARS-CoV-2,"['45 healthy adults, 18 to 55 years of age', 'adults']","['COVID-19 RNA vaccine BNT162b1', 'lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD']","['Geometric mean neutralizing titers', 'Local reactions and systemic events', 'RBD-binding IgG concentrations and SARS-CoV-2', 'reactogenicity', 'neutralizing titers']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0017968', 'cui_str': 'Glycoprotein'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",45.0,0.183612,RBD-binding IgG concentrations and SARS-CoV-2,"[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'New York University Langone Vaccine Center, New York, NY, USA.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Lyke', 'Affiliation': 'University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Kitchin', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Absalon', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA. judith.absalon@pfizer.com.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Gurtman', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Neuzil', 'Affiliation': 'University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Raabe', 'Affiliation': 'New York University Langone Vaccine Center, New York, NY, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Hurley, UK.'}, {'ForeName': 'Kena A', 'Initials': 'KA', 'LastName': 'Swanson', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Koury', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Kalina', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Fontes-Garfias', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Pei-Yong', 'Initials': 'PY', 'LastName': 'Shi', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Türeci', 'Affiliation': 'BioNTech, Mainz, Germany.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Tompkins', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Edward E', 'Initials': 'EE', 'LastName': 'Walsh', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frenck', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, OH, USA.""}, {'ForeName': 'Ann R', 'Initials': 'AR', 'LastName': 'Falsey', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Dormitzer', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Şahin', 'Affiliation': 'BioNTech, Mainz, Germany.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.'}]",Nature,['10.1038/s41586-020-2639-4']
1619,32785281,The impact of structured sleep schedules prior to an in-laboratory study: Individual differences in sleep and circadian timing.,"INTRODUCTION


Many sleep and circadian studies require participants to adhere to structured sleep-wake schedules designed to stabilize sleep outcomes and circadian phase prior to in-laboratory testing. The effectiveness of this approach has not been rigorously evaluated, however. We therefore investigated the differences between participants' unstructured and structured sleep over a three-week interval.
METHODS


Twenty-three healthy young adults completed three weeks of sleep monitoring, including one week of unstructured sleep and two weeks of structured sleep with consistent bed and wake times. Circadian phase was assessed via salivary dim light melatonin onset (DLMO) during both the unstructured and structured sleep episodes.
RESULTS


Compared to their unstructured sleep schedule, participants' bed- and wake times were significantly earlier in their structured sleep, by 34 ± 44 mins (M ± SD) and 44 ± 41 mins, respectively. During structured sleep, circadian phase was earlier in 65% of participants (40 ± 32 mins) and was later in 35% (41 ± 25 mins) compared to unstructured sleep but did not change at the group level. While structured sleep reduced night-to-night variability in sleep timing and sleep duration, and improved the alignment (phase angle) between sleep onset and circadian phase in the most poorly aligned individuals (DLMO < 1h or > 3h before sleep onset time; 25% of our sample), sleep duration and quality were unchanged.
CONCLUSION


Our results show adherence to a structured sleep schedule results in more regular sleep timing, and improved alignment between sleep and circadian timing for those individuals who previously had poorer alignment. Our findings support the use of structured sleep schedules prior to in-laboratory sleep and circadian studies to stabilize sleep and circadian timing in healthy volunteers.",2020,"During structured sleep, circadian phase was earlier in 65% of participants (40 ± 32 mins) and was later in 35% (41 ± 25 mins) compared to unstructured sleep but did not change at the group level.","['healthy volunteers', 'Twenty-three healthy young adults']",[],['sleep duration and quality'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",23.0,0.0294388,"During structured sleep, circadian phase was earlier in 65% of participants (40 ± 32 mins) and was later in 35% (41 ± 25 mins) compared to unstructured sleep but did not change at the group level.","[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'McMahon', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Ftouni', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew J K', 'Initials': 'AJK', 'LastName': 'Phillips', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Beatty', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Shanthakumar M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Maruff', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sean P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}]",PloS one,['10.1371/journal.pone.0236566']
1620,32756564,The effect of hydration status on plasma FGF21 concentrations in humans: A subanalysis of a randomised crossover trial.,"AIM


Fibroblast growth factor 21 (FGF21) has recently been implicated in thirst in rodent models. The mechanisms for this are currently uncertain, and it is unclear whether hydration status can alter FGF21 concentrations, potentially providing an additional mechanism by which hypohydration induces thirst. The aim of this study is therefore to understand whether hydration status can alter circulating FGF21 in humans.
METHODS


Using a heat tent and fluid restriction, we induced hypohydration (1.9% body mass loss) in 16 healthy participants (n = 8 men), and compared their glycaemic regulation to a rehydration protocol (heat tent and fluid replacement) in a randomised crossover design.
RESULTS


After the hypohydration procedure, urine specific gravity, urine and serum osmolality, and plasma copeptin (as a marker for arginine vasopressin) increased as expected, with no change after the rehydration protocol. In the fasted state, the median paired difference in plasma FGF21 concentrations from the rehydrated to hypohydrated trial arm was -37 (interquartile range -125, 10) pg∙mL-1(P = 0.278), with average concentrations being 458 ± 462 pg∙mL-1 after hypohydration and 467 ± 438 pg∙mL-1 after rehydration; mean difference -9 ± 173 pg∙mL-1.
CONCLUSION


To our knowledge, these are the first causal data in humans investigating hydration and FGF21, demonstrating that an acute bout of hypohydration does not impact fasted plasma FGF21 concentrations. These data may suggest that whilst previous research has found FGF21 administration can induce thirst and drinking behaviours, a physiological state implicated in increased thirst (hypohydration) does not appear to impact plasma FGF21 concentrations in humans.",2020,FGF21 concentrations from the rehydrated to hypohydrated trial arm was -37,"['16 healthy participants (n = 8 men', 'humans']","['hydration status', 'rehydration protocol (heat tent and fluid replacement', 'Fibroblast growth factor 21 (FGF21']","['FGF21 concentrations', 'urine specific gravity, urine and serum osmolality, and plasma copeptin (as a marker for arginine vasopressin', 'plasma FGF21 concentrations', 'plasma']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0034997', 'cui_str': 'Rehydration therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0677506', 'cui_str': 'Tent'}, {'cui': 'C0521302', 'cui_str': 'Body fluid replacement'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}]","[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0202517', 'cui_str': 'Urinalysis, specific gravity measurement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0202151', 'cui_str': 'Osmolality measurement, serum'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}]",16.0,0.122116,FGF21 concentrations from the rehydrated to hypohydrated trial arm was -37,"[{'ForeName': 'Harriet A', 'Initials': 'HA', 'LastName': 'Carroll', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Trim', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0235557']
1621,32758455,"Debio 1143 and high-dose cisplatin chemoradiotherapy in high-risk locoregionally advanced squamous cell carcinoma of the head and neck: a double-blind, multicentre, randomised, phase 2 study.","BACKGROUND


Debio 1143 is an orally available antagonist of inhibitor of apoptosis proteins with the potential to enhance the antitumour activity of cisplatin and radiotherapy. The radiosensitising effect of Debio 1143 is mediated through caspase activation and TNF, IFNγ, CD8 T cell-dependent pathways. We aimed to investigate the efficacy and safety of Debio 1143 in combination with standard chemoradiotherapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck.
METHODS


This double-blind, multicentre, randomised, phase 2 study by the French Head and Neck Radiotherapy Oncology Group (GORTEC) was run at 19 hospitals in France and Switzerland. Eligible patients were aged 18-75 years with locoregionally advanced, squamous cell carcinoma of the head and neck (characterised as non-metastatic, measurable stage III, IVa, or IVb [limited to T ≥2, N0-3, and M0] disease), Eastern Cooperative Oncology Group performance status of 0 or 1, a history of heavy tobacco smoking (>10 pack-years) with no previous or current treatment for invasive head and neck cancer, and no previous treatment with inhibitor of apoptosis protein antagonists. Patients were randomly assigned (1:1) to receive oral Debio 1143 (200 mg per day on days 1-14 of 21-day cycles, for three cycles) or oral placebo (20 mg/mL, administered at the same dosing schedule) using a stochastic minimisation technique according to node involvement and primary tumour site, and HPV-16 status in patients with an oropharyngeal primary tumour site. All patients received standard high-dose cisplatin chemoradiotherapy. The primary endpoint was the proportion of patients with locoregional control 18 months after chemoradiotherapy, analysed in the intention-to-treat population (primary analysis), and repeated in the per-protocol population. Responses were assessed according to Response Evaluation Criteria in Solid Tumors (version 1.1). This trial is registered with ClinicalTrials.gov, NCT02022098, and is still active but not recruiting.
FINDINGS


Between Jan 25, 2016, and April 24, 2017, 48 patients were randomly assigned to the Debio 1143 group and 48 to the placebo group (one patient in the placebo group did not receive the study drug and was not included in the safety analysis). Median duration of follow-up was 25·0 months (IQR 19·6-29·4) in the Debio 1143 group and 24·2 months (6·6-26·8) in the placebo group. Locoregional control 18 months after chemoradiotherapy was achieved in 26 (54%; 95% CI 39-69) of 48 patients in the Debio 1143 group versus 16 (33%; 20-48) of 48 patients in the placebo group (odds ratio 2·69 [95% CI 1·13-6·42], p=0·026). Grade 3 or worse adverse events were reported in 41 (85%) of 48 patients in the Debio 1143 group and in 41 (87%) of 47 patients in the placebo group. The most common grade 3-4 adverse events were dysphagia (in 24 [50%] patients in the Debio 1143 group vs ten [21%] in the placebo group), mucositis (in 15 [31%] vs ten [21%]), and anaemia (in 17 [35%] vs 11 [23%]). Serious treatment-emergent adverse events were recorded in 30 (63%) of 48 patients in the Debio 1143 group and 28 (60%) of 47 in the placebo group. In the placebo group, two (4%) deaths were due to adverse events (one multiple organ failure and one asphyxia; neither was considered to be related to treatment). No deaths due to adverse events occurred in the Debio 1143 group.
INTERPRETATION


To our knowledge, this is the first treatment regimen to achieve superior efficacy in this disease setting against a high-dose cisplatin chemoradiotherapy comparator in a randomised trial. These findings suggest that inhibition of inhibitor of apoptosis proteins is a novel and promising approach in this poor prognostic population and warrant confirmation in a phase 3 study with the aim of expanding the therapeutic options for these patients.
FUNDING


Debiopharm.",2020,"18 months after chemoradiotherapy was achieved in 26 (54%; 95% CI 39-69) of 48 patients in the Debio 1143 group versus 16 (33%; 20-48) of 48 patients in the placebo group (odds ratio 2·69 [95% CI 1·13-6·42], p=0·026).","['patients with an oropharyngeal primary tumour site', 'French Head and Neck Radiotherapy Oncology Group (GORTEC) was run at 19 hospitals in France and Switzerland', 'patients with high-risk locally advanced squamous cell carcinoma of the head and neck', 'high-risk locoregionally advanced squamous cell carcinoma of the head and neck', '48 patients were randomly assigned to the Debio 1143 group and 48 to the', 'Between Jan 25, 2016, and April 24, 2017', 'Eligible patients were aged 18-75 years with locoregionally advanced, squamous cell carcinoma of the head and neck (characterised as non-metastatic, measurable stage III, IVa, or IVb [limited to T ≥2, N0-3, and M0] disease), Eastern Cooperative Oncology Group performance status of 0 or 1, a history of heavy tobacco smoking (>10 pack-years) with no previous or current treatment for invasive head and neck cancer, and no previous treatment with inhibitor of apoptosis protein antagonists']","['standard high-dose cisplatin chemoradiotherapy', 'Debio 1143 in combination with standard chemoradiotherapy', 'cisplatin chemoradiotherapy comparator', 'oral placebo', 'oral Debio', 'Debio 1143 and high-dose cisplatin chemoradiotherapy', 'cisplatin and radiotherapy', 'placebo']","['proportion of patients with locoregional control', 'Median duration', 'dysphagia', 'caspase activation and TNF, IFNγ, CD8 T cell-dependent pathways', 'mucositis', 'efficacy and safety', 'anaemia', 'Serious treatment-emergent adverse events', 'adverse events', 'Locoregional control', 'Grade 3 or worse adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0475447', 'cui_str': 'Primary tumor site'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2983774', 'cui_str': 'AT 406'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0893445', 'cui_str': 'Inhibitor-Of-Apoptosis Protein'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C2983774', 'cui_str': 'AT 406'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",48.0,0.373852,"18 months after chemoradiotherapy was achieved in 26 (54%; 95% CI 39-69) of 48 patients in the Debio 1143 group versus 16 (33%; 20-48) of 48 patients in the placebo group (odds ratio 2·69 [95% CI 1·13-6·42], p=0·026).","[{'ForeName': 'Xu-Shan', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, Nord Franche-Comté de Montbéliard and CHRU de Besançon, Besançon, France.'}, {'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Radiation Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Le Tourneau', 'Affiliation': 'Department of Drug Development and Innovation, Institut Curie, Paris, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Oncologie-Radiothérapie, Institut Inter-RégionaL de Cancérologie, Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Bretagne Sud, Hôpital du Scorff Radiothérapie, Lorient, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Kaminsky', 'Affiliation': ""L'Institut de Cancérologie de Lorraine Alexis Vautrin, Oncologie Médicale, Vandoeuvre-lès-Nancy, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Coutte', 'Affiliation': 'CHU Amiens Picardie, Oncologie-Radiothérapie, Amiens, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Institut Sainte Catherine, Radiothérapie, Avignon, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': ""Institut du Cancer de Montpellier, Val d'Aurelle, Oncologie-Radiothérapie, Montpellier, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Centre Guillaume le Conquérant, Radiothérapie, Le Havre, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Miroir', 'Affiliation': 'Centre Jean Perrin, Radiothérapie, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Ramee', 'Affiliation': 'CHD Vendée, Radiothérapie, La Roche Sur Yon, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': ""Institut Claudius Regaud, Oncopole, Unité de Recherche Clinique de l'Institut Claudius Regaud, Toulouse, France.""}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Clatot', 'Affiliation': ""Centre Henri Becquerel, Service Oncologie Médicale rue d'Amiens, Rouen, France.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': ""Institut de Cancérologie de l'Ouest René Gauducheau, Institut de Cancérologie de l'Ouest, Saint-Herblain, France.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Villa', 'Affiliation': 'CHU Grenoble, Radiothérapie, Pôle de Cancérologie, Grenoble, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Magne', 'Affiliation': 'Institut de Cancérologie Lucien Neuwirth, Radiothérapie, Saint-Priest en Jarez, France.'}, {'ForeName': 'Olgun', 'Initials': 'O', 'LastName': 'Elicin', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Elisabeta', 'Initials': 'E', 'LastName': 'Gherga', 'Affiliation': 'Department of Radiation Oncology, Nord Franche-Comté de Montbéliard and CHRU de Besançon, Besançon, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Cedrick', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Oncologie-Radiothérapie, Institut Inter-RégionaL de Cancérologie, Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bera', 'Affiliation': 'Centre Hospitalier de Bretagne Sud, Hôpital du Scorff Radiothérapie, Lorient, France.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Calugaru', 'Affiliation': 'Department of Drug Development and Innovation, Institut Curie, Paris, France.'}, {'ForeName': 'Lionnel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': ""L'Institut de Cancérologie de Lorraine Alexis Vautrin, Oncologie Médicale, Vandoeuvre-lès-Nancy, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Chauffert', 'Affiliation': 'CHU Amiens Picardie, Oncologie-Radiothérapie, Amiens, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Zubel', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Zanna', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Silvano', 'Initials': 'S', 'LastName': 'Brienza', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Crompton', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Rouits', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Gollmer', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Szyldergemajn', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'CHUV, Service de Radio-oncologie, Bâtiment Hospitalier, Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30327-2']
1622,32758672,Beneficial Effects of Role Reversal in Comparison to role-playing on negative cognitions about Other's Judgments for Social Anxiety Disorder.,"BACKGROUND AND OBJECTIVES


Negative beliefs about other's judgments play an important role in the development and maintenance of social anxiety disorder. The present experiment examined the effects of role-playing followed by role reversal compared to role-playing twice on altering these negative cognitions.
METHODS


Thirty-six adult social anxiety patients were randomized into two conditions: a role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal. Before the start of the experiment, patients were asked to report their negative cognitions about the other's judgments. Next, they were asked to rate the believability of these negative cognitions, as well as the probability and cost estimates of negative judgments by the other person, at three time-points: before the first block of role-playing, after the first block of role-playing, and after the second block of the experiment.
RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
LIMITATIONS


The most important limitation of the present study is that there was no control group to assess the effects of role-playing alone. Moreover, the second block of the experiment was repetitive in role-playing, however, it was a new task in role reversal.
CONCLUSIONS


The results support the hypothesis that role reversal is an effective technique that can be used to correct negative cognitions about other's judgments in SAD.",2020,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","['Thirty-six adult social anxiety patients', ""negative cognitions about Other's Judgments for Social Anxiety Disorder""]","['role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",[],36.0,0.0134432,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Abeditehrani', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands. Electronic address: H.Abeditehrani@uva.nl.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Dijk', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Mohsen Dehghani', 'Initials': 'MD', 'LastName': 'Neyshabouri', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Department of Clinical Psychology, Tehran, Iran.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101599']
1623,32758677,Inspiratory neural drive and dyspnea in interstitial lung disease: Effect of inhaled fentanyl.,"BACKGROUND


Exertional dyspnea in interstitial lung disease (ILD) remains difficult to manage despite advances in disease-targeted therapies. Pulmonary opioid receptors present a potential therapeutic target for nebulized fentanyl to provide dyspnea relief.
METHODS


ILD patients were characterized with reference to healthy volunteers. A randomized, double-blind, placebo-controlled crossover comparison of 100 mcg nebulized fentanyl vs placebo on dyspnea intensity and inspiratory neural drive (IND) during constant work rate (CWR) cycle exercise was performed in 21 ILD patients.
RESULTS


Dyspnea intensity in ILD increased in association with an increase in IND (diaphragm activation) from a high resting value of 16.66 ± 6.52 %-60.04 ± 12.52 % of maximum (r = 0.798, p < 0.001). At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
CONCLUSION


IND rose sharply during constant work rate exercise in association with dyspnea intensity in mild to moderate ILD but was not different after nebulized fentanyl compared with placebo.",2020,"At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
","['ILD patients were characterized with reference to healthy volunteers', 'interstitial lung disease', '21 ILD patients']","['inhaled fentanyl', '100 mcg nebulized fentanyl vs placebo', 'nebulized fentanyl', 'fentanyl vs placebo', 'placebo']","['IND responses', 'IND (diaphragm activation', 'dyspnea intensity and inspiratory neural drive (IND) during constant work rate (CWR) cycle exercise', 'dyspnea intensity ratings', 'Inspiratory neural drive and dyspnea']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",21.0,0.334941,"At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
","[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Milne', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada; Clinician Investigator Program, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Ibrahim-Masthan', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Scheeren', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'James', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Phillips', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Onofre', 'Initials': 'O', 'LastName': 'Moran-Mendoza', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Neder', 'Initials': 'N', 'LastName': 'Ja', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada. Electronic address: odonnell@queensu.ca.""}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103511']
1624,32763640,Implementing an intensive care unit (ICU) diary program at a large academic medical center: Results from a randomized control trial evaluating psychological morbidity associated with critical illness.,"BACKGROUND


Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, including ICU-related post-traumatic stress disorder (PTSD), depression and anxiety. As we encounter a growing number of ICU survivors, in particular in the wake of the coronavirus pandemic, clinicians must be equipped to understand the severity and prevalence of significant psychiatric complications of critical illness.
METHODS


We compared the efficacy of the ICU diary, written by family and healthcare workers during the patient's intensive care course, versus education alone in reducing acute PTSD symptoms after discharge. Patients with an ICU stay >72 h, who were intubated and mechanically ventilated over 24 h, were recruited and randomized to either receive a diary at bedside with psychoeducation or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychological symptom screening with IES-R, PHQ-8, HADS and GAD-7 was conducted at baseline within 1 week of ICU discharge and at weeks 4, 12, and 24 after ICU discharge. Change from baseline in these scores was assessed using Wilcoxon rank sum tests.
RESULTS


From September 26, 2017 to September 25, 2018, our team screened 265 patients from the surgical and medical ICUs at a single large academic urban hospital. 60 patients were enrolled and randomized, of which 35 patients completed post-discharge follow-up, (n = 18) in the diary intervention group and (n = 17) in the education-only control group. The control group had a significantly greater decrease in PTSD, hyperarousal, and depression symptoms at week 4 compared to the intervention group. There were no significant differences in other measures, or at other follow-up intervals. Both study groups exhibited clinically significant PTSD symptoms at all timepoints after ICU discharge. Follow-up phone interviews with patients revealed that while many were interested in getting follow-up for their symptoms, there were many barriers to accessing appropriate therapy and clinical attention.
CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay. However, our study finds an important gap in clinical practice - patients at high risk for PICS are infrequently connected to appropriate follow-up care. Perhaps ICU diaries would prove beneficial if utilized to support the work within a program providing wrap-around services and close psychiatric follow up for PICS patients. This study demonstrates the high prevalence of ICU-related PTSD in our cohort of survivors, the high barrier to accessing care for appropriate treatment of PICS, and the consequence of that barrier-prolonged psychological morbidity.
TRIAL REGISTRATION


NCT04305353.
GRANT IDENTIFICATION


GH-17-022 (Arnold P. Gold Foundation).",2020,"CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay.","['From September 26, 2017 to September 25, 2018, our team screened 265 patients from the surgical and medical ICUs at a single large academic urban hospital', '60 patients', 'Patients with an ICU stay >72\u202fh, who were intubated and mechanically ventilated over 24\u202fh']","['intensive care unit (ICU) diary program', 'diary intervention group and (n\u202f=\u202f17) in the education-only control group', 'diary at bedside with psychoeducation or psychoeducation alone']","['acute PTSD symptoms', 'PTSD symptoms', 'PTSD, hyperarousal, and depression symptoms', 'Psychological symptom screening with IES-R, PHQ-8, HADS and GAD-7']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0747767', 'cui_str': 'Acute Post-Traumatic Stress Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}]",60.0,0.0503067,"CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay.","[{'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Sayde', 'Affiliation': 'Department of Internal Medicine and Psychiatry, Tulane University of School of Medicine, 1440 Canal Street, Suite 1000, New Orleans, LA 70112, USA. Electronic address: gsayde@tulane.edu.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Stefanescu', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, 1440 Canal Street, New Orleans, LA 70122, USA. Electronic address: astefanescu@tulane.edu.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Conrad', 'Affiliation': 'Department of Psychiatry, Louisiana State University, 2025 Gravier Street, New Orleans, LA 70112, USA. Electronic address: econra@lsuhsc.edu.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, University of New Mexico School of Medicine, 1 University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hammer', 'Affiliation': 'Department of Internal Medicine and Psychiatry, Tulane University of School of Medicine, 1440 Canal Street, Suite 1000, New Orleans, LA 70112, USA. Electronic address: rhammer@tulane.edu.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.017']
1625,32763776,Effect of brief encouragement to use twitter on knowledge of the critical-care literature by ICU residents: The randomized controlled IMKREASE trial.,,2020,,['ICU residents'],[],[],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",[],[],,0.0232695,,"[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: jeanbaptiste.lascarrou@chu-nantes.fr.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Tours, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Potier', 'Affiliation': 'Department of internal medicine, University Hospital Center, Nantes, France. Electronic address: pierre.potier@chu-nantes.fr.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reignier', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: jean.reignier@chu-nantes.fr.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Canet', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: emmanuel.canet@chu-nantes.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2020.07.022']
1626,32768394,Impact of aerobic training with and without whole-body vibration training on metabolic features and quality of life in non-alcoholic fatty liver disease patients.,"The present study examined the effectiveness of adding exercises with whole-body vibration (WBV) to aerobic training in terms of metabolic features and quality of life. Patients with non-alcoholic fatty liver disease (NAFLD), confirmed on imaging, underwent an 8-week individualized exercise program randomized between aerobic training with and without WBV. Training was performed at 60-80% heart rate workload for 165 min/week. The WBV amplitude was 2-4mm and the training frequency was 30Hz, for 15min. Assessments were carried out on surrogate scores of steatosis and fibrosis including transient elastography (FibroScan), metabolic features (biochemical analysis) and quality of life (SF-36). Insulin resistance was markedly reduced (-2.36; 95% CI: -4.96 to -0.24; P: 0.049) in aerobic training with WBV. The decrease in serum aspartate transaminase was significantly greater in aerobic training without WBV (-14.81; 95% CI: -23.36 to -6.25; P: 0.029). There were no significant differences between groups for the other metabolic features (P<0.05). All quality of life well-being domains improved in both groups (P<0.05). Given this reduction in insulin resistance, WBV can usefully be added to aerobic training. However, WBV did not provide further benefits in improving metabolic properties or quality of life.",2020,The decrease in serum aspartate transaminase was significantly greater in aerobic training without WBV (-14.81; 95%CI: -23.36 to -6.25; P: 0.029).,"['non-alcoholic fatty liver disease patients', 'Patients with non-alcoholic fatty liver disease confirmed on imaging underwent an 8-week']","['exercises with whole-body vibration (WBV) to aerobic training', 'individualized exercise program randomized between aerobic training with and without WBV', 'aerobic training with and without whole-body vibration training']","['surrogate scores of steatosis and fibrosis including transient elastography (FibroScan), metabolic features (biochemical analysis) and quality of life (SF-36', 'metabolic features and quality of life', 'serum aspartate transaminase', 'WBV amplitude', 'Insulin resistance', 'metabolic properties or quality of life']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.0409261,The decrease in serum aspartate transaminase was significantly greater in aerobic training without WBV (-14.81; 95%CI: -23.36 to -6.25; P: 0.029).,"[{'ForeName': 'Tülay', 'Initials': 'T', 'LastName': 'Çevik Saldiran', 'Affiliation': 'Department of physiotherapy and rehabilitation, faculty of health science, Bitlis Eren University, Ahmet-Eren boulevard, Rahva street, 13000 Bitlis, Turkey. Electronic address: tlyfztcvk@gmail.com.'}, {'ForeName': 'Fatma Karantay', 'Initials': 'FK', 'LastName': 'Mutluay', 'Affiliation': 'Department of physiotherapy and rehabilitation, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'İlker', 'Initials': 'İ', 'LastName': 'Yağci', 'Affiliation': 'Department of physical therapy and rehabilitation medicine, Marmara University, Istanbul, Istanbul, Turkey.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Yilmaz', 'Affiliation': 'Department of gastroenterology medicine, Marmara University, Istanbul, Istanbul, Turkey.'}]",Annales d'endocrinologie,['10.1016/j.ando.2020.05.003']
1627,32768465,Safety of Enalapril in Infants: Data from the Pediatric Heart Network Infant Single Ventricle Trial.,"OBJECTIVE


To assess the safety profile of angiotensin-converting enzyme inhibitor therapy in infants with single ventricle.
STUDY DESIGN


The Pediatric Heart Network conducted a double-blind trial involving infants with single ventricle physiology randomized to receive enalapril or placebo and followed to 14 months of age. Data including demographics, drug administration, hemodynamic monitoring, laboratory measurements, adverse events, and survival were extracted from the public use data set and compared between the placebo and enalapril-treated groups.
RESULTS


The Infant Single Ventricle trial randomized 230 patients, with 115 patients in each group. Initial enalapril dose was 0.10 mg/kg/d and median maximal dose was 0.38 mg/kg/d. There was no significant difference in change in blood pressure at study drug initiation or when resuming study drug after Glenn surgery. The incidence of hyperkalemia and neutropenia did not differ between groups. Renal dysfunction occurred in 3% of the enalapril group and none of the placebo patients, which was not statistically significant. There was a high frequency of serious adverse events in both groups. There was no difference in the frequency of heart transplant or death between groups.
CONCLUSIONS


Enalapril did not have sustained hemodynamic effects at initiation or up-titration of drug. Creatinine and potassium were not different between groups, although renal dysfunction occurred more often in the patients on enalapril. Although efficacy of enalapril in neonates with single ventricle has not been demonstrated, the safety profile of angiotensin-converting enzyme inhibitors appears to be low risk in infants and children with significant heart disease.",2020,There was no significant difference in change in blood pressure at study drug initiation or when resuming study drug after Glenn surgery.,"['Infants', 'infants with single ventricle (ISV', '230 patients, with 115 patients in each group', 'infants and children with significant heart disease', 'neonates and single ventricles', 'The Pediatric Heart Network (PHN) conducted a double-blind trial involving infants with single ventricle physiology randomized to receive']","['enalapril or placebo', 'enalapril', 'Initial enalapril', 'Enalapril', 'angiotensin converting enzyme (ACE) inhibitor therapy', 'placebo']","['blood pressure', 'frequency of heart transplant or death', 'Renal dysfunction', 'sustained hemodynamic effects', 'serious adverse events', 'Creatinine and potassium', 'demographics, drug administration, hemodynamic monitoring, laboratory measurements, adverse events, and survival', 'renal dysfunction', 'hyperkalemia and neutropenia']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152424', 'cui_str': 'Common ventricle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic monitoring'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",230.0,0.535615,There was no significant difference in change in blood pressure at study drug initiation or when resuming study drug after Glenn surgery.,"[{'ForeName': 'Kanika', 'Initials': 'K', 'LastName': 'Mathur', 'Affiliation': ""Division of Pediatric Cardiology, Children's Hospital at Montefiore/Albert Einstein College of Medicine, New York, NY. Electronic address: kanikamathur@gmail.com.""}, {'ForeName': 'Daphne T', 'Initials': 'DT', 'LastName': 'Hsu', 'Affiliation': ""Division of Pediatric Cardiology, Children's Hospital at Montefiore/Albert Einstein College of Medicine, New York, NY.""}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Lamour', 'Affiliation': ""Division of Pediatric Cardiology, Children's Hospital at Montefiore/Albert Einstein College of Medicine, New York, NY.""}, {'ForeName': 'Scott I', 'Initials': 'SI', 'LastName': 'Aydin', 'Affiliation': ""Division of Pediatric Cardiology, Children's Hospital at Montefiore/Albert Einstein College of Medicine, New York, NY; Division of Pediatric Critical Care, Children's Hospital at Montefiore/Albert Einstein College of Medicine, New York, NY.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.07.058']
1628,32768792,The emotion regulatory function of online social networking: Preliminary experimental evidence.,"Correlational research suggests that emotion regulation deficits, which are known risk factors for substance addictions, may also play a role in the development of problem behaviors such as excessive or maladaptive use of social networking sites (SNS). This study sought to experimentally assess the hypothesized emotion regulatory function of SNS use. 139 undergraduates (53.2% female) were randomized to view brief movie clips known to reliably induce positive (37.4%), negative (29.5%), or neutral mood (33.1%) and then to browse a SNS (46.8%) or control website (53.2%). Mood and subjective urge to access SNS and the Internet were assessed before and after viewing the movie clips and browsing the websites. Participants meeting criteria for ""moderate"" levels of disordered SNS use self-reported significantly greater deficits in emotion regulation (p = .02, η p 2  = 0.14). Increases in positive and negative affect following the mood induction were associated with a decrease in subjective urge to access SNS (r = -0.22, p = .02, r = -0.28, p = .002, respectively). Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09). We replicate previous findings of greater emotion regulation deficits in individuals endorsing problematic SNS use. Increased positive and negative affect resulted in decreased urge to access SNS, suggesting that social networking may primarily serve to counter low-arousal emotions like boredom. Data provide initial experimental evidence to support the hypothesized emotion regulatory function of SNS, with SNS exposure resulting in increased positive affect. Findings suggest that interventions targeting problematic SNS use should incorporate strategies for improved emotion regulation.",2020,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","['individuals endorsing problematic SNS use', '139 undergraduates (53.2% female']",[],"['subjective urge to access SNS', 'deficits in emotion regulation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0379552,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","[{'ForeName': 'Rae D', 'Initials': 'RD', 'LastName': 'Drach', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States.'}, {'ForeName': 'Natalia C', 'Initials': 'NC', 'LastName': 'Orloff', 'Affiliation': ""Department of Psychology, University at Albany, State University of New York, United States; Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, United States.""}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States. Electronic address: jhormes@albany.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106559']
1629,32772019,A Proactive Mobile Health Application Program for Promoting Self-Care Health Management among Older Adults in the Community: Study Protocol of a Three-Arm Randomized Controlled Trial.,"BACKGROUND


The use of mobile health (mHealth) has become common in recent years and is regarded as one of the most effective interventions for developing disease-specific management skills and establishing confidence in making preventive health behavior changes and accomplishing health-related goals among community-dwelling older adults. Most mHealth designs adopt a reactive care approach whereby health care professionals do not respond until they receive abnormal assessment results from the database or a message or signal from the client. The purpose of this study is to determine the effectiveness of a proactive mobile health application program with the support of a community health-social care team for older adults dwelling in the community on improving their self-care health management.
METHODS


This is a three-armed, randomized controlled trial. The study will be conducted in 7 community centers with an estimated sample size of 282 participants. The participants will be randomly assigned to mHealth with interactivity, mHealth, and control groups when they are (1) aged 60 or above, (2) complaining chiefly of pain, hypertension, or diabetes mellitus, (3) living within the service areas, and (4) smartphone users. Subjects in the mHealth with interactivity group will receive 2 main elements, the mHealth application and nurse case management supported by a social service team. The mHealth group will receive the mHealth application only. The primary outcome measure will be self-efficacy, and secondary outcomes will include self-management outcomes (pain score, blood pressure, capillary blood glucose), client outcomes (quality of life, depression), and health service utilization outcomes (institutionalization and health service utilization [general practitioner, outpatient clinic, emergency room, hospital admission]). Data will be collected before intervention, after intervention, and 3 months after intervention.
DISCUSSION


The incremental benefits of adding interactivity in the mHealth program have not been confirmed. This present study will add valuable information to the knowledge gap of whether mHealth with nurse interaction supported by a health-social partnership can improve self-care management among community-dwelling older adults.",2020,"Subjects in the mHealth with interactivity group will receive 2 main elements, the mHealth application and nurse case management supported by a social service team.","['Older Adults in the Community', '7 community centers with an estimated sample size of 282 participants', 'community-dwelling older adults', 'older adults dwelling in the community on improving their self-care health management', 'groups when they are (1) aged 60 or above, (2) complaining chiefly of pain, hypertension, or diabetes mellitus, (3) living within the service areas, and (4) smartphone users']","['mHealth application and nurse case management supported by a social service team', 'proactive mobile health application program', 'Proactive Mobile Health Application Program', 'mHealth with interactivity, mHealth, and control']","['self-efficacy, and secondary outcomes will include self-management outcomes (pain score, blood pressure, capillary blood glucose), client outcomes (quality of life, depression), and health service utilization outcomes (institutionalization and health service utilization [general practitioner, outpatient clinic, emergency room, hospital admission']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0021629', 'cui_str': 'Institutionalization'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",282.0,0.0681252,"Subjects in the mHealth with interactivity group will receive 2 main elements, the mHealth application and nurse case management supported by a social service team.","[{'ForeName': 'Arkers Kwan Ching', 'Initials': 'AKC', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China, arkers.wong@polyu.edu.hk.'}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Katherine Ka Pik', 'Initials': 'KKP', 'LastName': 'Chang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}]",Gerontology,['10.1159/000509129']
1630,32776828,Testosterone supplementation upregulates androgen receptor expression and translational capacity during severe energy deficit.,"Testosterone supplementation during energy deficit promotes whole body lean mass accretion, but the mechanisms underlying that effect remain unclear. To elucidate those mechanisms, skeletal muscle molecular adaptations were assessed from muscle biopsies collected before, 1 h, and 6 h after exercise and a mixed meal (40 g protein, 1 h postexercise) following 14 days of weight maintenance (WM) and 28 days of an exercise- and diet-induced 55% energy deficit (ED) in 50 physically active nonobese men treated with 200 mg testosterone enanthate/wk (TEST) or placebo (PLA) during the ED. Participants ( n  = 10/group) exhibiting substantial increases in leg lean mass and total testosterone (TEST) were compared with those exhibiting decreases in both of these measures (PLA). Resting androgen receptor (AR) protein content was higher and fibroblast growth factor-inducible 14 (Fn14), IL-6 receptor (IL-6R), and muscle ring-finger protein-1 gene expression was lower in TEST vs. PLA during ED relative to WM ( P  < 0.05). Changes in inflammatory, myogenic, and proteolytic gene expression did not differ between groups after exercise and recovery feeding. Mechanistic target of rapamycin signaling (i.e., translational efficiency) was also similar between groups at rest and after exercise and the mixed meal. Muscle total RNA content (i.e., translational capacity) increased more during ED in TEST than PLA ( P  < 0.05). These findings indicate that attenuated proteolysis at rest, possibly downstream of AR, Fn14, and IL-6R signaling, and increased translational capacity, not efficiency, may drive lean mass accretion with testosterone administration during energy deficit.",2020,"Muscle total RNA content (i.e., translational capacity) increased more during ED in TEST than PLA (P < 0.05).",[],"['Testosterone supplementation', 'rapamycin', '200 mg testosterone enanthate/week (TEST) or placebo (PLA', 'exercise- and diet-induced 55% energy deficit (ED']","['Changes in inflammatory, myogenic, and proteolytic gene expression', 'Muscle total RNA content (i.e., translational capacity', 'Resting androgen receptor (AR) protein content', 'mTOR) signaling (i.e., translational efficiency', 'IL-6 receptor (IL-6R), and muscle ring-finger protein-1 (MuRF1) gene expression']",[],"[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0076189', 'cui_str': 'Testosterone enanthate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0597304', 'cui_str': 'Protein Degradation'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C1699800', 'cui_str': 'IL6R protein, human'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}]",50.0,0.0901914,"Muscle total RNA content (i.e., translational capacity) increased more during ED in TEST than PLA (P < 0.05).","[{'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Howard', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Margolis', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Berryman', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Harris R', 'Initials': 'HR', 'LastName': 'Lieberman', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Karl', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Young', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Monty A', 'Initials': 'MA', 'LastName': 'Montano', 'Affiliation': 'MyoSyntax Corporation, Worcester, Massachusetts.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Evans', 'Affiliation': 'University of California at Berkeley, Berkeley, California.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Rodriguez', 'Affiliation': 'University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Johannsen', 'Affiliation': ""Louisiana State University's Pennington Biomedical Research Center, Baton Rouge, Louisiana.""}, {'ForeName': 'Kishore M', 'Initials': 'KM', 'LastName': 'Gadde', 'Affiliation': ""Louisiana State University's Pennington Biomedical Research Center, Baton Rouge, Louisiana.""}, {'ForeName': 'Melissa N', 'Initials': 'MN', 'LastName': 'Harris', 'Affiliation': ""Louisiana State University's Pennington Biomedical Research Center, Baton Rouge, Louisiana.""}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Rood', 'Affiliation': ""Louisiana State University's Pennington Biomedical Research Center, Baton Rouge, Louisiana.""}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Pasiakos', 'Affiliation': 'Military Nutrition Division, United States Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00157.2020']
1631,32780744,Comparison of alternative full and brief versions of functional status scales among older adults in China.,"BACKGROUND


Brief assessments of functional status for community-dwelling older adults are needed given expanded interest in the measurement of functional decline.
METHODS


As part of a 2015 prospective cohort study of older adults aged 60-89 years in Jiangsu Province, China, 1506 participants were randomly assigned to two groups; each group was administered one of two alternative 20-item versions of a scale to assess activities of daily living (ADL) and instrumental activities of daily living (IADL) drawn from multiple commonly-used scales. One version asked if they required help to perform activities (ADL-IADL-HELP-20), while the other version provided additional response options if activities could be done alone but with difficulty (ADL-IADL-DIFFICULTY-20). Item responses to both versions were compared using the binomial test for differences in proportion (with Wald 95% confidence interval [CI]). A brief 9-item scale (ADL-IADL-DIFFICULTY-9) was developed favoring items identified as difficult or requiring help by ≥4%, with low redundancy and/or residual correlations, and with significant correlations with age and other health indicators. We repeated assessment of the measurement properties of the brief scale in two subsequent samples of older adults in Hong Kong in 2016 (aged 70-79 years; n = 404) and 2017 (aged 65-82 years; n = 1854).
RESULTS


Asking if an activity can be done alone but with difficulty increased the proportion of participants reporting restriction on 9 of 20 items, for which 95% CI for difference scores did not overlap with zero; the proportion with at least one limitation increased from 28.6% to 34.2% or an absolute increase of 5.6% (95% CI = 0.9-10.3%), which was a relative increase of 19.6%. The brief ADL-IADL-DIFFICULTY-9 maintained excellent internal consistency (α = 0.93) and had similar ceiling effect (68.1%), invariant item ordering (H trans = .41; medium), and correlations with age and other health measures compared with the 20-item version. The brief scale performed similarly when subsequently administered to older adults in Hong Kong.
CONCLUSIONS


Asking if tasks can be done alone but with difficulty can modestly reduce ceiling effects. It's possible that the length of commonly-used scales can be reduced by over half if researchers are primarily interested in a summed indicator rather than an inventory of specific types of deficits.",2020,"Asking if an activity can be done alone but with difficulty increased the proportion of participants reporting restriction on 9 of 20 items, for which 95% CI for difference scores did not overlap with zero; the proportion with at least one limitation increased from 28.6% to 34.2% or an absolute increase of 5.6% (95% CI = 0.9-10.3%), which was a relative increase of 19.6%.","['older adults in Hong Kong', 'older adults in Hong Kong in 2016 (aged 70-79 years; n = 404) and 2017 (aged 65-82 years; n = 1854', 'community-dwelling older adults', 'older adults in China', 'older adults aged 60-89 years in Jiangsu Province, China, 1506 participants']",[],['activities of daily living (ADL) and instrumental activities of daily living (IADL'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008115', 'cui_str': 'China'}]",[],"[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}]",1506.0,0.113087,"Asking if an activity can be done alone but with difficulty increased the proportion of participants reporting restriction on 9 of 20 items, for which 95% CI for difference scores did not overlap with zero; the proportion with at least one limitation increased from 28.6% to 34.2% or an absolute increase of 5.6% (95% CI = 0.9-10.3%), which was a relative increase of 19.6%.","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Reich', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Thompson', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Cowling', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'A Danielle', 'Initials': 'AD', 'LastName': 'Iuliano', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Greene', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Yuyun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Phadnis', 'Affiliation': 'Abt Associates, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Nancy H L', 'Initials': 'NHL', 'LastName': 'Leung', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Vicky J', 'Initials': 'VJ', 'LastName': 'Fang', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Cuiling', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Chinese National Influenza Center, National Institute for Viral Disease Control and Prevention, Collaboration Innovation Center for Diagnosis and Treatment of Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Qigang', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Department of Acute Infectious Disease Control and Prevention, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Suzhou Center for Disease Prevention and Control, Suzhou, China.'}, {'ForeName': 'Hongjun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Yancheng Center for Disease Prevention and Control, Yancheng, China.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Havers', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0234698']
1632,32788139,"Cost-effectiveness of SMS appointment reminders in increasing vaccination uptake in Lagos, Nigeria: A multi-centered randomized controlled trial.","OBJECTIVE


It is expected that mHealth largely contribute to increasing the coverages of key maternal and child health services. This study aims to estimate the cost-effectiveness of the SMS text reminders in clients' return visits to the health facilities for child vaccinations (incl. vitamin A supplementations), antenatal care (ANC) and family planning (FP), in urban communities of Lagos, Nigeria.
METHODS


A multi-centered randomized control trial was conducted at 33 primary health centers (PHCs) in Lagos, Nigeria. All the clients having visited any of the 33 PHCs for child vaccinations, ANC and FP were randomly assigned either to intervention group or to control group. The participants in the intervention group were sent an SMS text reminder two days before their appointments. Those not having showed up on the appointment dates received an additional SMS text reminder seven days after original appointment dates as defaulter tracing. The primary outcome was whether a client made return visit to PHCs for the upcoming appointments.
RESULTS


Of 12,779 appointments for 9,368 clients during the period of 1stApril to 30thJune 2019, 12,175 were included in the analysis. The return rate for child vaccinations in the intervention group was significantly higher (p < 0.001) by 4.8% - 6.0% than that in the control group, consistently across all the five different timings (on time as scheduled, and by 7 days, 14 days, 30 days, and 3 months after appointment dates). No significant difference between the two groups was detected in the increase in return rates for ANC and FP services. The incremental recurrent cost was estimated at 7.90 US Dollars per return case.
CONCLUSION


SMS text reminders led to a significant increase in the number of return visits for child vaccinations, Lagos, Nigeria, while no significant increase in return visits was confirmed for ANC and FP appointments.",2020,"The return rate for child vaccinations in the intervention group was significantly higher (p < 0.001) by 4.8% - 6.0% than that in the control group, consistently across all the five different timings (on time as scheduled, and by 7 days, 14 days, 30 days, and 3 months after appointment dates).","['clients having visited any of the 33 PHCs for child vaccinations, ANC and FP', '33 primary health centers (PHCs) in Lagos, Nigeria', 'urban communities of Lagos, Nigeria', 'Lagos, Nigeria', 'Of 12,779 appointments for 9,368 clients during the period of 1stApril to 30thJune 2019', ""clients' return visits to the health facilities for child vaccinations (incl""]","['vitamin A supplementations), antenatal care (ANC) and family planning (FP', 'SMS text reminders', 'SMS appointment reminders']","['return rate for child vaccinations', 'return visits', 'incremental recurrent cost', 'return rates for ANC and FP services', 'cost-effectiveness', 'client made return visit to PHCs for the upcoming appointments', 'number of return visits']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0268281', 'cui_str': 'Infantile neuronal ceroid lipofuscinosis'}]","[{'cui': 'C4524019', 'cui_str': 'Vitamin A supplementation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0378836,"The return rate for child vaccinations in the intervention group was significantly higher (p < 0.001) by 4.8% - 6.0% than that in the control group, consistently across all the five different timings (on time as scheduled, and by 7 days, 14 days, 30 days, and 3 months after appointment dates).","[{'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Kawakatsu', 'Affiliation': 'Department of Global Health, University of Washington, USA. Electronic address: yoshitok@uw.edu.'}, {'ForeName': 'Adefunke', 'Initials': 'A', 'LastName': 'Oyeniyi Adesina', 'Affiliation': 'Lagos State Ministry of Health, Lagos, Nigeria.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Kadoi', 'Affiliation': 'Project for Strengthening Pro-poor Community Health Services in Lagos State, Nigeria.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Aiga', 'Affiliation': 'School of Tropical Medicine and Global Health, Nagasaki University, Nagasaki, Japan.'}]",Vaccine,['10.1016/j.vaccine.2020.07.075']
1633,32788673,Correction: Prevention of obesity in toddlers (PROBIT): a randomised clinical trial of responsive feeding promotion from birth to 24 months.,"In the original Article, Dr. Laura Fontana's name was missing from the author list. This has been corrected (Dr. Fontana's name and details have been added to the HTML, PDF and XML version of this Article).",2020,"This has been corrected (Dr. Fontana's name and details have been added to the HTML, PDF and XML version of this Article).",['obesity in toddlers (PROBIT'],[],[],"[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]",[],[],,0.0210562,"This has been corrected (Dr. Fontana's name and details have been added to the HTML, PDF and XML version of this Article).","[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Morandi', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Tommasi', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Soffiati', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Florinda', 'Initials': 'F', 'LastName': 'Destro', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Grando', 'Affiliation': 'Dolomiti Local Health and Social Care Service, Belluno, Italy.'}, {'ForeName': 'Giustina', 'Initials': 'G', 'LastName': 'Simonetti', 'Affiliation': 'Dolomiti Local Health and Social Care Service, Belluno, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Bucolo', 'Affiliation': 'Euganea Local Health and Social Care Service, Padua, Italy.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Alberti', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Baraldi', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'Chiriacò', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Ferrarese', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Graziana', 'Initials': 'G', 'LastName': 'Frignani', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Pasqualini', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Rossi', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Siciliano', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Zuccolo', 'Affiliation': 'Polesana Local Health and Social Care Service, Rovigo, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Matticchio', 'Affiliation': 'Berica Local Health and Social Care Service, Vicenza, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Vettori', 'Affiliation': 'Berica Local Health and Social Care Service, Vicenza, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Danieli', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Guarda', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Iuliano', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raimo', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Sirpresi', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Trevisan', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Vinco', 'Affiliation': 'Scaligera Local Health and Social Care Service, Verona, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Maffeis', 'Affiliation': 'Pediatric Diabetes and Metabolic Disorders Unit, University Hospital of Verona, Verona, Italy. Claudio.maffeis@univr.it.'}]",International journal of obesity (2005),['10.1038/s41366-020-00651-y']
1634,32791048,"Sorafenib maintenance in patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised phase 3 trial.","BACKGROUND


Findings of retrospective studies suggest that sorafenib maintenance post-transplantation might reduce relapse in patients with FLT3 internal tandem duplication (FLT3-ITD) acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation. We investigated the efficacy and tolerability of sorafenib maintenance post-transplantation in this population.
METHODS


We did an open-label, randomised phase 3 trial at seven hospitals in China. Eligible patients (aged 18-60 years) had FLT3-ITD acute myeloid leukaemia, were undergoing allogeneic haematopoietic stem-cell transplantation, had an Eastern Cooperative Oncology Group performance status of 0-2, had composite complete remission before and after transplantation, and had haematopoietic recovery within 60 days post-transplantation. Patients were randomly assigned (1:1) to sorafenib maintenance (400 mg orally twice daily) or non-maintenance (control) at 30-60 days post-transplantation. Randomisation was done with permuted blocks (block size four) and implemented through an interactive web-based randomisation system. The primary endpoint was the 1-year cumulative incidence of relapse in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02474290; the trial is complete.
FINDINGS


Between June 20, 2015, and July 21, 2018, 202 patients were enrolled and randomly assigned to sorafenib maintenance (n=100) or control (n=102). Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0). The 1-year cumulative incidence of relapse was 7·0% (95% CI 3·1-13·1) in the sorafenib group and 24·5% (16·6-33·2) in the control group (hazard ratio 0·25, 95% CI 0·11-0·57; p=0·0010). Within 210 days post-transplantation, the most common grade 3 and 4 adverse events were infections (25 [25%] of 100 patients in the sorafenib group vs 24 [24%] of 102 in the control group), acute graft-versus-host-disease (GVHD; 23 [23%] of 100 vs 21 [21%] of 102), chronic GVHD (18 [18%] of 99 vs 17 [17%] of 99), and haematological toxicity (15 [15%] of 100 vs seven [7%] of 102). There were no treatment-related deaths.
INTERPRETATION


Sorafenib maintenance post-transplantation can reduce relapse and is well tolerated in patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation. This strategy could be a suitable therapeutic option for patients with FLT3-ITD acute myeloid leukaemia.
FUNDING


None.",2020,Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0).,"['Between June 20, 2015, and July 21, 2018, 202 patients were enrolled and randomly assigned to', 'patients with FLT3-ITD acute myeloid leukaemia', 'patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation', 'Eligible patients (aged 18-60 years) had FLT3-ITD acute myeloid leukaemia, were undergoing allogeneic haematopoietic stem-cell transplantation, had an Eastern Cooperative Oncology Group performance status of 0-2, had composite complete remission before and after transplantation, and had haematopoietic recovery within 60 days post-transplantation', 'seven hospitals in China', 'n=100) or control (n=102', 'patients with FLT3 internal tandem duplication (FLT3-ITD) acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation']","['sorafenib', 'sorafenib maintenance (400 mg orally twice daily) or non-maintenance (control', 'Sorafenib maintenance', 'sorafenib maintenance post-transplantation', 'sorafenib maintenance']","['chronic GVHD', '1-year cumulative incidence of relapse', 'efficacy and tolerability', 'haematological toxicity', 'acute graft-versus-host-disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0018957', 'cui_str': 'Hematopoietic system structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}]",202.0,0.369632,Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xuan', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xinquan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""Department of Hematology, First People's Hospital of Chenzhou, Chenzhou, China.""}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhixiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Chunzi', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': ""Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Sanfang', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Qifa', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China. Electronic address: liuqifa628@163.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30455-1']
1635,32795597,Racial disparities in out-of-hospital cardiac arrest interventions and survival in the Pragmatic Airway Resuscitation Trial.,"BACKGROUND


Prior studies have reported racial disparities in survival from out-of-hospital cardiac arrest (OHCA). However, these studies did not evaluate the association of race with OHCA course of care and outcomes. The purpose of this study was to evaluate racial disparities in OHCA airway placement success and patient outcomes in the multicenter Pragmatic Airway Resuscitation Trial (PART).
METHOD


We conducted a secondary analysis of adult OHCA patients enrolled in PART. The parent trial randomized subjects to initial advanced airway management with laryngeal tube or endotracheal intubation. For this analysis, the primary independent variable was patient race categorized by emergency medical services (EMS) as white, black, Hispanic, other, and unknown. We used general estimating equations to examine the association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster.
RESULTS


Of 3002 patients, EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown. Initial shockable rhythms (13.8% vs. 21.5%, p < 0.001), bystander CPR (35.6% vs. 51.4%, p < 0.001), and survival to hospital discharge (7.6% vs. 10.8%, p = 0.011) were lower for black compared to white patients. After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
CONCLUSIONS


In one of the largest studies evaluating differences in prehospital airway interventions and outcomes by EMS-assessed race for OHCA patients, we found no significant adjusted differences between airway success or survival outcomes.",2020,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[' EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown', '3002 patients', 'adult OHCA patients enrolled in PART']",['initial advanced airway management with laryngeal tube or endotracheal intubation'],"['association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster', 'airway success, 72-h survival, and survival to hospital discharge by race', 'Initial shockable rhythms', 'survival to hospital discharge', 'bystander CPR', 'airway success or survival outcomes']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3002.0,0.089249,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health & Science University, United States. Electronic address: lupton@ohsu.edu.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Blewer', 'Affiliation': 'Duke University School of Medicine, United States.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'University of Pittsburgh School of Medicine, United States.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'Allegheny Health Network, United States.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health & Science University, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, United States.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health & Science University, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2020.08.004']
1636,32795738,Predictors of receptivity to an alcohol intervention among mandated students.,"OBJECTIVE


Students in violation of campus alcohol policy often must participate in an alcohol risk reduction intervention, and some mandated students express overt resistance to change. This study tested a priori hypotheses about psychological variables that might predict receptivity to an online brief alcohol intervention.
METHOD


Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations. Before their mandated online alcohol intervention, they completed a baseline assessment consisting of demographics and questionnaires about their alcohol use, attitudes toward moderate and heavy drinking, beliefs about the centrality of alcohol in college life, perceived descriptive and injunctive drinking norms, trait defensiveness, social desirability and response to the event leading to their sanction. They also responded to a set of questions about how interested in, open-minded, and likely to benefit they were from the computer-delivered alcohol intervention they were about to take.
RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
CONCLUSIONS


Among students mandated to participate in an alcohol intervention, openness to benefitting from the intervention varies in predictable ways. Because intervention receptiveness is associated with post-intervention change, we offer suggestions to tailor mandated interventions in ways that might improve outcomes.",2020,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","['Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations', 'mandated students']",['alcohol intervention'],"['heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",193.0,0.0120224,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","[{'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Behavioral and Social Sciences, Brown University School of Public Health, United States. Electronic address: Kate_Carey@Brown.edu.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Psychology, City University of New York, Brooklyn College, United States.'}, {'ForeName': 'Elora E', 'Initials': 'EE', 'LastName': 'Orazio', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Hatch', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Department of Psychology, Binghamton University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106605']
1637,32758684,Is it worth using low-cost glass ionomer cements for occlusal ART restorations in primary molars? 2-year survival and cost analysis of a Randomized clinical trial.,"OBJECTIVE


To evaluate the 2-year survival rate and the cost-effectiveness of Atraumatic Restorative Treatment (ART) using three different glass ionomer cements (GICs) for restoring occlusal dentin caries lesions in primary molars.
METHODS


One hundred and fifty (150) 4-8-year-old children were selected, randomly allocated and treated in school tables according to the restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM), the latter two being low-cost brands. Materials and professionals' costs were considered to analyse baseline total cost, and from this the cumulative cost of each treatment was calculated. Restoration assessments were performed after 2, 6, 12 and 24 months by an independent calibrated examiner. Restoration survival was estimated using Kaplan-Meier survival analysis and Cox regression was used to test association with clinical factors. Bootstrap regression (1,000 replications) compared material´s cost over time and Monte-Carlo simulation was used to build cost-effectiveness scatter plots.
RESULTS


The overall survival rate of occlusal ART restorations after 2 years was 53% (Fuji IX = 72.7%; Vitro Molar = 46.5%; Maxxion R = 39.6%). Restorations performed with Vitro Molar and Maxxion R were more likely to fail when compared to Fuji IX. At baseline, Fuji IX was the more expensive option (p < 0.001), however, considering the simulation of accumulated cost caused by failures until 2-year evaluation, no difference was found between the groups.
CONCLUSIONS


After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).",2020,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","['150 4-8-year-old children', 'primary molars']","['glass ionomer cements (GICs', 'restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM', 'Atraumatic Restorative Treatment (ART', 'Fuji IX']","['overall survival rate of occlusal ART restorations', 'Restoration survival', '2-year survival rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0671561', 'cui_str': 'fuji IX'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C3529286', 'cui_str': 'Maxxion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0977731,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","[{'ForeName': 'Isabel Cristina', 'Initials': 'IC', 'LastName': 'Olegário', 'Affiliation': 'Department of Public and Child Dental Health, Dublin Dental University Hospital, University of Dublin, Trinity College, Dublin, Ireland; Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nathalia de Miranda', 'Initials': 'NM', 'LastName': 'Ladewig', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hesse', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Clarissa Calil', 'Initials': 'CC', 'LastName': 'Bonifácio', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Carlos Pettorossi', 'Initials': 'JCP', 'LastName': 'Imparato', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: danielar@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103446']
1638,32758689,"SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial.","BACKGROUND


The antiviral effects of Novaferon, a potent antiviral protein drug, on COVID-19 was evaluated in the laboratory, and in a randomized, open-label, parallel-group trial.
METHODS


In the laboratory, Novaferon's inhibition of viral replication in cells infected with SARS-CoV-2, and prevention of SARS-CoV-2 entry into healthy cells was determined. Antiviral effects of Novaferon in COVID-19 patients with treatment of Novaferon, Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir were evaluated. The primary endpoint was the SARS-CoV-2 clearance rates on day six of treatment, and the secondary endpoint was the time to SARS-CoV-2 clearance.
RESULTS


Novaferon inhibited viral replication (EC 50 =1.02ng/ml), and prevented viral infection (EC 50 =0.10ng/ml). Results from the 89 enrolled COVID-19 patients showed that both Novaferon and Novaferon plus Lopinavir/Ritonavir groups had significantly higher viral clearance rates on day six than Lopinavir/Ritonavir group (50.0% vs. 24.1%, p=0.0400, and 60.0% vs. 24.1%, p=0.0053). The median time to viral clearance was six days, six days, and nine days for three groups, respectively, a 3-day reduction in both the Novaferon and Novaferon plus Lopinavir/Ritonavir groups compared with the Lopinavir/Ritonavir group.
CONCLUSIONS


Novaferon exhibited anti-SARS-CoV-2 effects in vitro and in COVID-19 patients. These data justify further evaluation of Novaferon.
TRIAL REGISTRATION NUMBER


Number ChiCTR2000029496 at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/).",2020,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","['COVID-19 patients with treatment of Novaferon', 'COVID-19 Patients with Novaferon Treatment']","['Lopinavir/Ritonavir', 'Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir', 'Novaferon', '6than Lopinavir/Ritonavir']","['viral infection', 'SARS-CoV-2 Clearance', 'Median time to viral clearance', 'viral replication', 'SARS-CoV-2 clearance rates', 'time to SARS-CoV-2 clearance', 'viral clearance rates']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0042774', 'cui_str': 'Virus Replication'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",89.0,0.111733,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Baoying', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yaxiong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zuo', 'Affiliation': 'Department of Intensive Care Unit, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Pediatrics, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Internal Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Peihua', 'Initials': 'P', 'LastName': 'Niu', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xinqiang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, National Clinical Research Center for Metabolic Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: jiangyongfang@csu.edu.cn.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China. Electronic address: 1286779459@qq.com.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: tanwj@ivdc.chinacdc.cn.'}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: gongguozhong@csu.edu.cn.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.07.053']
1639,32759621,Ileal and Rectal Ulcer Size Affects the Ability to Achieve Endoscopic Remission: A Post hoc Analysis of the SONIC Trial.,"INTRODUCTION


It is unclear how baseline endoscopic characteristics in Crohn's disease (CD) affect the ability to achieve endoscopic remission (ER). We aimed to determine the endoscopic prognostic factors that influence achieving ER in CD.
DESIGN


This post hoc analysis of SONIC (NCT00094458; YODA #2019-3980) evaluated baseline and week 26 endoscopy indices in 172 patients using the CD Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score for CD. The impact of baseline ulcer depth and size on achieving week 26 ER was assessed using multivariate logistic regression models adjusted for confounders.
RESULTS


The ER rate of ileal ulcers was significantly lower than ER rates throughout the colon (P < 0.0001). Ileal ulcers >2 cm were less likely to achieve ER compared with smaller ulcers {odds ratio (OR) 0.31 (95% confidence interval [CI] 0.11-0.89), P = 0.03}. Similarly, rectal ulcers >2 cm were associated with reduced odds of week 26 ER (OR 0.26 [95% CI 0.08-0.80], P = 0.02). Ulcer size in other colonic segments did not affect the achievement of week 26 ER. Deep ileal and rectal ulcers >2 cm compared with smaller or superficial ulcers were even less likely to achieve week 26 ER (ileum: OR 0.10, 95% CI 0.02-0.68, P = 0.02; rectum: OR 0.12, 0.02-0.82, P = 0.03). High baseline Simple Endoscopic Score for CD (≥16) or CDEIS scores (≥12) did not affect achieving week 26 ER.
DISCUSSION


Patients with larger and deep ulcers in the ileum or rectum may have difficulty achieving ER. Overall degree of endoscopic inflammation as measured numerically by endoscopic scores does not affect the likelihood of achieving week 26 ER.",2020,The ER rate of ileal ulcers was significantly lower than ER rates throughout the colon (P < 0.0001).,['172 patients using the CD Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score for CD'],[],"['Deep ileal and rectal ulcers', 'Endoscopic Remission', 'High baseline Simple Endoscopic Score for CD (≥16) or CDEIS scores', 'Overall degree of endoscopic inflammation', 'Ileal and Rectal Ulcer', 'ER rate of ileal ulcers', 'Ulcer size']","[{'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",[],"[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0020885', 'cui_str': 'Ileal structure'}, {'cui': 'C0400839', 'cui_str': 'Ulcer of rectum'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0520564', 'cui_str': 'Ileal ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0988739,The ER rate of ileal ulcers was significantly lower than ER rates throughout the colon (P < 0.0001).,"[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Narula', 'Affiliation': '1Division of Gastroenterology, Department of Medicine and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton Ontario, Canada; 2Division of Gastroenterology, University of California San Diego, La Jolla, California, USA; 3Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA; 4Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium; 5Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Emily C L', 'Initials': 'ECL', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Achuthan', 'Initials': 'A', 'LastName': 'Aruljothy', 'Affiliation': ''}, {'ForeName': 'Parambir S', 'Initials': 'PS', 'LastName': 'Dulai', 'Affiliation': ''}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Colombel', 'Affiliation': ''}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Marshall', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ferrante', 'Affiliation': ''}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Reinisch', 'Affiliation': ''}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000617']
1640,32762995,"Mapping From Visual Acuity to EQ-5D, EQ-5D With Vision Bolt-On, and VFQ-UI in Patients With Macular Edema in the LEAVO Trial.","OBJECTIVES


Mappings to convert clinical measures to preference-based measures of health such as the EQ-5D-3L are sometimes required in cost-utility analyses. We developed mappings to convert best-corrected visual acuity (BCVA) to the EQ-5D-3L, the EQ-5D-3L with a vision bolt-on (EQ-5D V), and the Visual Functioning Questionnaire-Utility Index (VFQ-UI) in patients with macular edema caused by central retinal vein occlusion.
METHODS


We used data from Lucentis, Eylea, Avastin in vein occlusion (LEAVO), which is a phase-3 randomized controlled trial comparing ranibizumab, aflibercept, and bevacizumab in 463 patients with observations at 6 time points. We estimated adjusted limited dependent variable mixture models consisting of 1 to 4 distributions (components) using BCVA in each eye, age, and sex to predict utility within the components and BCVA as a determinant of component membership. We compared model fit using mean error, mean absolute error, root mean square error, Akaike information criteria, Bayesian information criteria, and visual inspection of mean predicted and observed utilities and cumulative distribution functions.
RESULTS


Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI. The best-fitting models for the EQ-5D and EQ-5D V had 2 components (with means of approximately 0.44 and 0.85), and the best-fitting model for VFQ-UI had 3 components (with means of approximately 0.95, 0.74, and 0.90).
CONCLUSIONS


Models with multiple components better predict utility than those with single components. This article provides a valuable addition to the literature, in which previous mappings in visual acuity have been limited to linear regressions, resulting in unfounded assumptions about the distribution of the dependent variable.",2020,"Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI.","['patients with macular edema caused by central retinal vein occlusion', '463 patients with observations at 6 time points', 'Patients With Macular Edema in the LEAVO Trial']","['ranibizumab, aflibercept, and bevacizumab', 'Lucentis, Eylea, Avastin in vein occlusion (LEAVO']","['mean error, mean absolute error, root mean square error, Akaike information criteria, Bayesian information criteria, and visual inspection of mean predicted and observed utilities and cumulative distribution functions', 'Mean utility scores', 'Visual Functioning Questionnaire-Utility Index (VFQ-UI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0154841', 'cui_str': 'Central retinal vein occlusion'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",463.0,0.141225,"Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI.","[{'ForeName': 'Becky M', 'Initials': 'BM', 'LastName': 'Pennington', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK. Electronic address: b.pennington@sheffield.ac.uk.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Hernández-Alava', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hykin', 'Affiliation': 'National Institute for Health Research Moorfields Biomedical Research Centre, London, England, UK.'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'National Institute for Health Research Moorfields Biomedical Research Centre, London, England, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Flight', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'Abualbishr', 'Initials': 'A', 'LastName': 'Alshreef', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brazier', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.03.008']
1641,32764908,Cost-Effectiveness Analysis of a Once-Daily Single-Inhaler Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease (COPD) Using the FULFIL Trial: A Spanish Perspective.,"Purpose


To evaluate the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) vs twice-daily budesonide/formoterol (BUD/FOR) in patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations, from the Spanish National Healthcare System perspective.
Patients and Methods


The validated GALAXY-COPD model was used to simulate disease progression and predict healthcare costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 3-year time horizon for a Spanish population. Patient characteristics from published literature were supplemented by data from FULFIL (NCT02345161), which compared FF/UMEC/VI vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations. Treatment effects, extrapolated to 3 years, were based on Week 24 results in the FULFIL intent-to-treat population, including change in forced expiratory volume in 1 second, St. George's Respiratory Questionnaire score, and exacerbation rates. Treatment, exacerbations, and COPD management costs (2019€) were informed by Spanish public sources and published literature. A 3% discount rate for costs and benefits was applied. One-way sensitivity and scenario analyses, and probabilistic sensitivity analysis (PSA), were performed.
Results


FF/UMEC/VI treatment led to fewer moderate and severe exacerbations (2.126 and 0.306, respectively) vs BUD/FOR (2.608 and 0.515, respectively), with a mean incremental cost of €69 and gain of 0.107 QALYs, which resulted in an ICER of €642 per QALY gained. In sensitivity analyses, the ICER was most sensitive to treatment effect variations in exacerbations and healthcare resource utilization/event costs. Overall, 95% of 1000 PSA simulations resulted in an ICER less than €11,000 per QALY gained for FF/UMEC/VI vs BUD/FOR, confirming robustness of the results. The probability of FF/UMEC/VI being cost-effective vs BUD/FOR was 100% at a willingness-to-pay threshold of €30,000 per QALY gained.
Conclusion


At the accepted Spanish ICER threshold of €30,000, FF/UMEC/VI represents a cost-effective treatment option vs BUD/FOR in patients with symptomatic COPD at risk of exacerbations.",2020,"In sensitivity analyses, the ICER was most sensitive to treatment effect variations in exacerbations and healthcare resource utilization/event costs.","['patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations, from the Spanish National Healthcare System perspective', 'Patients with Chronic Obstructive Pulmonary Disease (COPD', 'patients with symptomatic COPD at risk of exacerbations']","['Once-Daily Single-Inhaler Triple Therapy', 'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) vs twice-daily budesonide/formoterol (BUD/FOR']","['healthcare costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'moderate and severe exacerbations', 'Treatment, exacerbations, and COPD management costs', 'cost-effectiveness', ""forced expiratory volume in 1 second, St. George's Respiratory Questionnaire score, and exacerbation rates"", 'probability of FF/UMEC/VI being cost-effective vs BUD/FOR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}]","[{'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}]",,0.272579,"In sensitivity analyses, the ICER was most sensitive to treatment effect variations in exacerbations and healthcare resource utilization/event costs.","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schroeder', 'Affiliation': 'Value Evidence and Outcomes, GlaxoSmithKline plc., Brentford, UK.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Benjamin', 'Affiliation': 'Global Health Economics, ICON plc., Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Atienza', 'Affiliation': 'Market Access, GlaxoSmithKline SA, Madrid, Spain.'}, {'ForeName': 'Chandroday', 'Initials': 'C', 'LastName': 'Biswas', 'Affiliation': 'Global Health Economics, ICON plc., Bengaluru, Karnataka, India.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Value Evidence and Outcomes, GlaxoSmithKline plc., Uxbridge, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Whalen', 'Affiliation': 'Global Health Economics, ICON plc., Abingdon, UK.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Izquierdo Alonso', 'Affiliation': 'Pneumology, Hospital Universitario de Guadalajara, Guadalajara, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Riesco Miranda', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Servicio de Neumología, Hospital San Pedro de Alcántara, Cáceres, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Soler-Cataluña', 'Affiliation': 'Pneumology Department, Hospital Arnau de Vilanova-Lliria (Valencia), Valencia, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Huerta', 'Affiliation': 'Market Access, GlaxoSmithKline SA, Madrid, Spain.'}, {'ForeName': 'Afisi S', 'Initials': 'AS', 'LastName': 'Ismaila', 'Affiliation': 'Value Evidence and Outcomes, GlaxoSmithKline plc., Collegeville, PA, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S240556']
1642,32764918,The Summit Score Stratifies Mortality and Morbidity in Chronic Obstructive Pulmonary Disease.,"Introduction


Tobacco use and other cardiovascular risk factors often accompany chronic obstructive pulmonary disease (COPD). This study derived and validated the Summit Score to predict mortality in people with COPD and cardiovascular risks.
Methods


SUMMIT trial subjects (N=16,485) ages 40-80 years with COPD were randomly assigned 50%/50% to derivation (N=8181) and internal validation (N=8304). Three external COPD validations from Intermountain Healthcare included outpatients with cardiovascular risks (N=9251), outpatients without cardiovascular risks (N=8551), and inpatients (N=26,170). Cox regression evaluated 40 predictors of all-cause mortality. SUMMIT treatments including combined fluticasone furoate (FF) 100μg/vilanterol 25μg (VI) were not included in the score.
Results


Mortality predictors were FEV 1 , heart rate, systolic blood pressure, body mass index, age, smoking pack-years, prior COPD hospitalizations, myocardial infarction, heart failure, diabetes, anti-thrombotics, anti-arrhythmics, and xanthines. Combined in the Summit Score (derivation: c=0.668), quartile 4 vs 1 had HR=4.43 in SUMMIT validation (p<0.001, 95% CI=3.27, 6.01, c=0.662) and HR=8.15 in Intermountain cardiovascular risk COPD outpatients (p<0.001, 95% CI=5.86, 11.34, c=0.736), and strongly predicted mortality in the other Intermountain COPD populations. Among all SUMMIT subjects with scores 14-19, FF 100μg/VI 25μg vs placebo had HR=0.76 (p=0.0158, 95% CI=0.61, 0.95), but FF 100μg/VI 25μg was not different from placebo for scores <14 or >19.
Conclusion


In this post hoc analysis of SUMMIT trial data, the Summit Score was derived and validated in multiple Intermountain COPD populations. The score was used to identify a subpopulation in which mortality risk was lower for FF 100μg/VI 25μg treatment.
Trial Registration


The SUMMIT trial is registered at ClinicalTrials.gov as number NCT01313676.",2020,"Combined in the Summit Score (derivation: c=0.668), quartile 4 vs 1 had HR=4.43 in SUMMIT validation (p<0.001, 95% CI=3.27, 6.01, c=0.662) and HR=8.15 in Intermountain cardiovascular risk COPD outpatients (p<0.001, 95% CI=5.86, 11.34, c=0.736), and strongly predicted mortality in the other Intermountain COPD populations.","['people with COPD and cardiovascular risks', 'outpatients with cardiovascular risks (N=9251), outpatients without cardiovascular risks (N=8551), and inpatients (N=26,170', 'accompany chronic obstructive pulmonary disease (COPD', 'Chronic Obstructive Pulmonary Disease', 'Methods\n\n\nSUMMIT trial subjects (N=16,485) ages 40-80 years with COPD']","['fluticasone furoate', 'placebo']","['Summit Score Stratifies Mortality and Morbidity', 'mortality risk', 'FEV 1 , heart rate, systolic blood pressure, body mass index, age, smoking pack-years, prior COPD hospitalizations, myocardial infarction, heart failure, diabetes, anti-thrombotics, anti-arrhythmics, and xanthines']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0043314', 'cui_str': 'xanthine'}]",3.0,0.500894,"Combined in the Summit Score (derivation: c=0.668), quartile 4 vs 1 had HR=4.43 in SUMMIT validation (p<0.001, 95% CI=3.27, 6.01, c=0.662) and HR=8.15 in Intermountain cardiovascular risk COPD outpatients (p<0.001, 95% CI=5.86, 11.34, c=0.736), and strongly predicted mortality in the other Intermountain COPD populations.","[{'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Horne', 'Affiliation': 'Intermountain Medical Center Heart Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hegewald', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Intermountain Medical Center, Salt Lake City, UT, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'Research and Development, GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Rea', 'Affiliation': 'Care Transformation, Intermountain Healthcare, Salt Lake City, UT, USA.'}, {'ForeName': 'Tami L', 'Initials': 'TL', 'LastName': 'Bair', 'Affiliation': 'Intermountain Medical Center Heart Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Denitza P', 'Initials': 'DP', 'LastName': 'Blagev', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Intermountain Medical Center, Salt Lake City, UT, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S254437']
1643,31810854,Transcutaneous Tibial Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction: A Pilot Study for an International Multicenter Randomized Controlled Trial.,"BACKGROUND


Tibial nerve stimulation (TNS) is an effective and safe treatment for idiopathic lower urinary tract dysfunction (LUTD), but its value in neurological patients is unclear.
OBJECTIVE


To test the feasibility, acceptability, and safety of a randomized, sham-controlled, double-blind transcutaneous TNS (TTNS) setup for treating neurogenic LUTD.
DESIGN, SETTING, AND PARTICIPANTS


A pilot study including nine patients with refractory neurogenic LUTD investigated prospectively at a university neuro-urology department.
INTERVENTION


Randomized, sham-controlled, double-blind verum and sham TTNS was performed for 30min twice a week, for 6 wks.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Outcomes were feasibility, acceptability, and safety of the TTNS protocol. Secondarily, potential efficacy was investigated. Descriptive statistics were used.
RESULTS AND LIMITATIONS


All procedures were feasible and well tolerated by all nine patients. Using verum TTNS, a motor response could be triggered in all patients and a sensory response in all but one. At the beginning and end of treatment, seven and six (78% and 67%) patients believed to receive verum TTNS, and five and six (56% and 67%) correctly guessed their group allocation, respectively. No treatment-related adverse events occurred. A comparison of baseline versus 6 wks of verum and sham TTNS led to relevant symptom and functional changes in only a limited number of piloted patients.
CONCLUSIONS


Verum and sham TTNS combined with the blinding procedures proved feasible and safe. Both interventions and procedures, as well as the randomization process, were well accepted by the patients. While the subsensory threshold TTNS approach in combination with the sham condition is advantageous for patients' blinding, the clinical findings raised some doubt regarding sufficient TNS. Hence, relevant methodological adjustments concerning the adequate stimulation current and corresponding sham condition are needed before starting randomized controlled trials to clarify the value and role of TTNS in neuro-urology.
PATIENT SUMMARY


Transcutaneous tibial nerve stimulation is a promising treatment option for neurogenic lower urinary tract dysfunction, but methodological adjustments in treatment application are required before further prospective studies can be initiated.",2020,No treatment-related adverse events occurred.,"['nine patients with refractory neurogenic LUTD investigated prospectively at a university neuro-urology department', 'Treating Neurogenic Lower Urinary Tract Dysfunction']","['Tibial nerve stimulation (TNS', 'Transcutaneous Tibial Nerve Stimulation', 'Transcutaneous tibial nerve stimulation', 'sham-controlled, double-blind verum and sham TTNS', 'verum and sham TTNS', 'sham-controlled, double-blind transcutaneous TNS (TTNS']","['feasible and safe', 'feasibility, acceptability, and safety', 'feasible and well tolerated', 'feasibility, acceptability, and safety of the TTNS protocol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0587531', 'cui_str': 'Urology department'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0045733', 'cui_str': '2-(4-toluidino)-6-naphthalenesulfonic acid'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0045733', 'cui_str': '2-(4-toluidino)-6-naphthalenesulfonic acid'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",9.0,0.128069,No treatment-related adverse events occurred.,"[{'ForeName': 'Jure', 'Initials': 'J', 'LastName': 'Tornic', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Martina D', 'Initials': 'MD', 'LastName': 'Liechti', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Stalder', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Birkhäuser', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'van der Lely', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Leitner', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mehnert', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kessler', 'Affiliation': 'Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland. Electronic address: tkessler@gmx.ch.'}]",European urology focus,['10.1016/j.euf.2019.11.008']
1644,32778913,"Acute mechanical, physiological and perceptual responses in older men to traditional-set or different cluster-set configuration resistance training protocols.","PURPOSE


The aims of this study were to compare mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses in older men to traditional-set or different cluster-set configuration resistance training protocols.
METHODS


In a randomized cross-over design, 20 healthy old men (aged 67.2 ± 2.1 years) completed four resistance training sessions using the back squat exercise loaded with optimal power loads. Training configurations were: traditional (TRA), three sets of six repetitions with 120-s rest between each set; Cluster-set 1 (CLU1), 24 single-repetition clusters with 10 s of rest after every cluster; Cluster-set 2 (CLU2), 12 double-repetition clusters with 20-s rest after every cluster; and Cluster-set 4 (CLU4), 6 quadruple-repetition clusters with 40-s rest after every cluster.
RESULTS


Cluster-set configurations resulted in greater power outputs compared to traditional-set configuration (range 2.6-9.2%, all p [Formula: see text] 0.07 for main effect and protocol [Formula: see text] set interactions). CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU, all p [Formula: see text] 0.006 for pairwise comparisons) and lower ratings of fatigue (range - 0.15 to - 4 AU, all p [Formula: see text] 0.012 for pairwise comparisons) compared to TRA and CLU4. Finally, an absolute preference for CLU2 was reported.
CONCLUSIONS


Findings presented here support the prescription of CLU2 as an optimal resistance training configuration for trained older men using the back squat.",2020,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","['trained older men using the back squat', '20 healthy old men (aged 67.2\u2009±\u20092.1\xa0years', 'older men to traditional-set or different cluster-set configuration resistance training protocols', 'older men']","['CLU1 and CLU2', 'resistance training sessions using the back squat exercise loaded with optimal power loads']","['heart rate', 'lower ratings of fatigue', 'mechanical outputs (i.e. power and impulse), physiological (i.e. heart rate) and perceptual (i.e. effort and fatigue) responses', 'Acute mechanical, physiological and perceptual responses']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",,0.043265,"CLU1 and CLU2 induced higher heart rate (range 7.1-10.5%, all p < 0.001 for main effect and protocol [Formula: see text] set interactions), lower rating of perceived exertion (range - 1.3 to - 3.2 AU,","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dello Iacono', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK. antonio.delloiacono@uws.ac.uk.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Martone', 'Affiliation': ""Universita' Degli Studi di Napoli (Dipartimento di Science Motorie e Benessere), Naples, Italy.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'University of the West of Scotland (School of Health and Life Sciences), Hamilton, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04453-y']
1645,32777383,"Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).","OBJECTIVE


To describe the rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).
METHOD


This phase 2 clinical trial was designed to evaluate the use of intranasal oxytocin treatment to improve social difficulties in individuals with autism spectrum disorder (ASD). In total, 290 participants ages 3 to 17 years with a DSM-5 diagnosis of ASD were enrolled to receive 24 weeks of treatment with either oxytocin or a matched placebo at one of seven collaborating sites. Participants were subsequently treated with open-label oxytocin for 24 additional weeks. Post-treatment assessments were done approximately 4 weeks after treatment discontinuation. Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, and week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
RESULTS


This report describes the rationale, design, and methods of the SOARS-B clinical trial.
CONCLUSIONS


There is a tremendous unmet need for safe and effective pharmacological treatment options that target the core symptoms of ASD. Several studies support the hypothesis that intranasal oxytocin could improve social orienting and the salience of social rewards in ASD, thereby enhancing reciprocal social behaviors. However, due to conflicting results from a number of pilot studies on the prosocial effects of exogenous oxytocin, this hypothesis remains controversial and inconclusive. SOARS-B is the best powered study to date to address this hypothesis and promises to improve our understanding of the safety and efficacy of intranasal oxytocin in the treatment of social deficits in children with ASD.",2020,"Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
","['individuals with autism spectrum disorder (ASD', 'children with ASD', '290 participants ages 3 to 17\u202fyears with a DSM-5 diagnosis of ASD']","['oxytocin', 'intranasal oxytocin', 'Oxytocin', 'open-label oxytocin', 'oxytocin or a matched placebo']","['Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level', 'Reciprocal Social Behaviors (SOARS-B', 'reciprocal social behaviors (SOARS-B', 'social orienting', 'social difficulties']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0069841', 'cui_str': 'Oxytocin Receptor'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",290.0,0.0611497,"Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response.
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Spanos', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: marina.spanos@duke.edu.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Chandrasekhar', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Soo-Jeong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ""Seattle Children's Autism Center, Department of Psychiatry and Behavioral Sciences, University of Washington; Seattle, WA, United States of America.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hamer', 'Affiliation': 'Departments of Psychiatry and Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Bryan H', 'Initials': 'BH', 'LastName': 'King', 'Affiliation': ""Department of Psychiatry and Weill Institute for Neurosciences, University of California San Francisco, UCSF Benioff Children's Hospitals, San Francisco, CA, United States of America.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'McDougle', 'Affiliation': 'Lurie Center for Autism, Massachusetts General Hospital; Department of Psychiatry, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Kevin B', 'Initials': 'KB', 'LastName': 'Sanders', 'Affiliation': 'Neuroscience Product Development, F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Gregory', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, United States of America; Department of Neurology, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Seaver Autism Center for Research and Treatment, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Veenstra-VanderWeele', 'Affiliation': 'Department of Psychiatry, Columbia University; New York State Psychiatric Institute; Center for Autism and the Developing Brain, New York-Presbyterian Hospital, United States of America.'}, {'ForeName': 'Linmarie', 'Initials': 'L', 'LastName': 'Sikich', 'Affiliation': 'Duke Center for Autism and Brain Development, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106103']
1646,32777552,Evolution of Endoscopic Lesions in Steroid-Refractory Acute Severe Ulcerative Colitis Responding to Infliximab or Cyclosporine.,"BACKGROUND/AIMS


Few data on the evolution of endoscopic findings are available in patients with acute severe ulcerative colitis (ASUC). The aim of this study was to describe this evolution in a prospective cohort.
METHODS


Patients admitted for a steroid-refractory ASUC and included in a randomized trial comparing infliximab and cyclosporine were eligible if they achieved steroid-free clinical remission at day 98. Flexible sigmoidoscopies were performed at baseline, days 7, 42 and 98. Ulcerative colitis endoscopic index of severity (UCEIS) and its sub-scores - vascular pattern, bleeding and ulceration/erosion - were post-hoc calculated. Global endoscopic remission was defined by a UCEIS of 0, and partial endoscopic remission by any UCEIS sub-score of 0.
RESULTS


Among the 55 patients analyzed (29 infliximab and 26 cyclosporine), 49 (83%) had UCEIS ≥6 at baseline at baseline. Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n = 55); p = .004 and p=.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<.001 for both] and at day 98 [78% and 92% vs. 56% (n = 50); p = .007 and p < .001]. Global endoscopic remission rates at day 98 were higher in patients treated with infliximab than with cyclosporine [73% vs. 25% (n = 26 and 24); p < .001].
CONCLUSION


In steroid-refractory ASUC patients responding to a second-line medical therapy, endoscopic remission process started with bleeding remission and was not achieved in half the patients at day 98 for vascular pattern. Infliximab provided a higher endoscopic remission rate than cyclosporine at day 98.",2020,"Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n=55); p=0.004 and p=0.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<0.001 for both] and at day 98 [78% and 92% vs. 56% (n=50); p=0.007 and p<0.001].","['patients with acute severe ulcerative colitis (ASUC', 'Patients admitted for a steroid-refractory ASUC and included in a randomized trial comparing']","['infliximab and cyclosporine', 'infliximab or cyclosporine', 'Infliximab', 'infliximab', 'cyclosporine']","['Global endoscopic remission', 'Global endoscopic remission rates', 'Ulcerative colitis endoscopic index of severity (UCEIS) and its sub-scores - vascular pattern, bleeding and ulceration/erosion ', 'Partial endoscopic remission rates', 'ulcerations/erosions', 'endoscopic remission rate', 'bleeding and ulceration/erosion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.13872,"Partial endoscopic remission rates were higher for bleeding than for vascular pattern and for ulcerations/erosions at day 7 (20% vs. 4% and 5% (n=55); p=0.004 and p=0.04), for bleeding and ulceration/erosion than for vascular pattern at day 42 [63% and 65% vs. 33% (n=54); p<0.001 for both] and at day 98 [78% and 92% vs. 56% (n=50); p=0.007 and p<0.001].","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Laharie', 'Affiliation': ""INSERM CIC 1401, Service d'hépato-gastroentérologie et oncologie digestive, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, CHU de Bordeaux, Université de Bordeaux, Bordeaux, France. Electronic address: david.laharie@chu-bordeaux.fr.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourreille', 'Affiliation': ""Institut des Maladies de l'Appareil Digestif, Hépato-Gastroentérologie, Hôtel-Dieu, CHU de Nantes, Nantes, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Branche', 'Affiliation': ""Service des maladies de l'appareil digestif-Endoscopie digestive, Hôpital Claude Huriez, CHRU de Lille, Lille, France.""}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Allez', 'Affiliation': ""Service d'Hépato-Gastroentérologie, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Paris, France.""}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Bouhnik', 'Affiliation': 'Gastroentérologie, MICI et Assistance Nutritive, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Clichy, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Filippi', 'Affiliation': ""Service de Gastroentérologie et Nutrition Clinique, Hôpital de l'Archet 2, CHU de Nice, Nice, France.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zerbib', 'Affiliation': ""INSERM CIC 1401, Service d'hépato-gastroentérologie et oncologie digestive, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, CHU de Bordeaux, Université de Bordeaux, Bordeaux, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Savoye', 'Affiliation': 'UMR 1073, Service de Gastroentérologie, Hôpital Charles Nicolle, CHU de Rouen, Normandie Université-Rouen, Rouen, France.'}, {'ForeName': 'Lucine', 'Initials': 'L', 'LastName': 'Vuitton', 'Affiliation': 'Service de Gastroentérologie, Hôpital Jean Minjoz, CHU de Besançon, Besançon, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Moreau', 'Affiliation': 'Service de Gastro-entérologie et Nutrition, Hôpital Rangueil, CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Aurelien', 'Initials': 'A', 'LastName': 'Amiot', 'Affiliation': ""Service d'Hépato-gastroentérologie, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Université Créteil, Créteil, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Beaugerie', 'Affiliation': ""Department of Gastroenterology, Institut Pierre Louis d'Epidémiologie et de Santé Publique, INSERM, Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ricart', 'Affiliation': 'Gastroenterology Department, Hospital Clínic, Augus Pi i Sunyer Biomedical Research Institute, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Barcelona, Spain.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Dewit', 'Affiliation': ""Service d'Hépato-Gastroentérologie, UCL Saint Luc, Brussels, Belgium.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez-Sanroman', 'Affiliation': 'Unidad de EII / IBD Unit, Servicio de Gastroenterología y Hepatología, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Mathurin', 'Initials': 'M', 'LastName': 'Fumery', 'Affiliation': ""Peritox UMR I-01, Service d'Hépato-Gastroentérologie, CHU Amiens, Amiens, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Carbonnel', 'Affiliation': ""Service d'Hépato-Gastroentérologie, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Université Paris Sud 11, Le Kremlin-Bicêtre, France.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Buisson', 'Affiliation': ""INSERM U1071, M2iSH, USC-INRA 2018, 3iHP, Service d'Hépato-Gastroentérologie, CHU Clermont-Ferrand, Université Clermont Auvergne, Clermont-Ferrand, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Coffin', 'Affiliation': ""Pôle Maladie Appareil Digestif, Service d'Hépato-Gastroentérologie, Hôpital Louis Mourier, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Colombes, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Roblin', 'Affiliation': 'Service de Gastro-entérologie et Hépatologie, Hôpital Nord, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'van Assche', 'Affiliation': 'Division of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Esteve', 'Affiliation': 'Department of Gastroenterology, Hospital Universitari Mútua de Terrassa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Terrassa, Spain.'}, {'ForeName': 'Martti', 'Initials': 'M', 'LastName': 'Farkkila', 'Affiliation': 'Clinic of Gastroenterology, Helsinki University Central Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Gisbert', 'Affiliation': 'Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa, Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Marteau', 'Affiliation': 'Service Hépato-gastroentérologie, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris Sorbonne Université, Paris, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Nahon', 'Affiliation': ""Service d'Hépato-gastroentérologie, CHI Le Raincy Montfermeil, Montfermeil, France.""}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'de Vos', 'Affiliation': 'Ghent University Hospital, Gent, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'INSERM U1256 NGERE, Department of Hepato-Gastroenterology, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Mary', 'Affiliation': 'INSERM UMR-S-1153, Equipe ECSTRA, Hôpital Saint-Louis, Paris Diderot University, Paris, France.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.08.001']
1647,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND


With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS


A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS


After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6 %), five cases in the Lianhua group (8.6 %), and seven cases in the western medicine group (11.1 %). There was no statistical differences in this rate among the three groups (P >  0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION


The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tina_yai@126.com.""}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
1648,32781360,"Intrauterine administration of autologous hCG- activated peripheral blood mononuclear cells improves pregnancy outcomes in patients with recurrent implantation failure; A double-blind, randomized control trial study.","We aimed to investigate the effect of intrauterine administration of autologous hCG-activated PBMCs in RIF women with low Th-17/Treg cell ratio. 248 women with a history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients were randomly divided into two groups as PBMC receiving (n = 50) and controls (n = 50). Then PBMCs were obtained from patients and treated with hCG for 48 h. Afterward, PBMCs were administered into the uterine cavity of the patient in the study group, two days before ET. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs after 2, 24, and 48 h of incubation using the ELISA method. The frequency of Th-17, Treg, and the Th-17/Treg ratio was significantly lower in RIF women than the healthy controls (P < 0.0001). The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001). The pregnancy and live birth rate were significantly increased in women undergoing the PBMC-therapy compared to control (PBS-injecting) group (P = 0.032 and P = 0.047, respectively). The miscarriage rate was considerably lower in PBMC-therapy group (P = 0.029). Our findings suggest that intrauterine administration of autologous in vitro hCG-activated PBMCs improves pregnancy outcomes in patients with at least three IVF/ET failures.",2020,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"['100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control', 'patients with recurrent implantation failure', '100 patients', 'RIF women with low Th-17/Treg cell ratio', '248 women with a history of implantation failure volunteered to receive']","['hCG', 'autologous hCG-activated PBMCs', 'autologous hCG- activated peripheral blood mononuclear cells', 'PBMC-therapy']","['concentration of inflammatory cytokines', 'pregnancy and live birth rate', 'pregnancy outcomes', 'miscarriage rate', 'secretion of inflammatory cytokines', 'frequency of Th-17, Treg, and the Th-17/Treg ratio']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",248.0,0.138794,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourmoghadam', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Sheikhansari', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ramyar', 'Initials': 'R', 'LastName': 'Azizi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Siahmansouri', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii', 'Affiliation': 'Gynecology Department, Eastern Azerbaijan ACECR ART center, Eastern Azerbaijan branch of ACECR, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hojjat-Farsangi', 'Affiliation': 'Department of Oncology-Pathology, Immune and Gene Therapy Lab, Cancer Center Karolinska (CCK), Karolinska University Hospital Solna and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103182']
1649,32781371,A pragmatic randomised controlled trial of the fostering changes programme.,"BACKGROUND


Many looked after young people in Wales are cared for by foster or kinship carers, usually as a consequence of maltreatment or developmentally traumatising experiences within a family context. Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
OBJECTIVE


To determine whether group-based training improves foster carer self-efficacy.
PARTICIPANTS AND SETTING


Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks. Carers from households where one or more carer had previously attended the training were not eligible. Sixteen local authorities and three independent fostering providers in Wales took part.
METHODS


The primary outcome measure was the Carer Efficacy Questionnaire assessed at 12 months. Secondary outcomes included the Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves.
RESULTS


312 consented foster carers were allocated to FC (n = 204) or usual care (n = 108) group. 65.3 % of FC group participants attended sufficient training sessions (8/12, including sessions three and four). There were no differences in carer-reported self-efficacy at 12 months (adjusted difference in means (95 % CI): -0.19 (-1.38 to 1.00)). Small differences in carer-reported child behaviour difficulties and carer coping strategies over time favoured the intervention but these effects diminished from three to 12 months. No other intervention effects were observed.
CONCLUSIONS


Although well-received by participants, training was associated with small and mostly short-term benefit for trial secondary outcomes.",2020,"Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
","['Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks', 'Sixteen local authorities and three independent fostering providers in Wales took part', '312 consented foster carers']","['usual care', 'FC']","['foster carer self-efficacy', 'carer-reported self-efficacy', 'Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves', 'Carer Efficacy Questionnaire']","[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",[],"[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",312.0,0.166724,"Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
","[{'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Moody', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: MoodyG@cardiff.ac.uk.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: JohnE1@cardiff.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: Brookes-HowellLC@cardiff.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: CanningsRL@cardiff.ac.uk.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: ChannonS2@cardiff.ac.uk.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: LauTM@cardiff.ac.uk.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Rees', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom, Wales. Electronic address: ReesA1@cardiff.ac.uk.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Segrott', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: SegrottJ@cardiff.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scourfield', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: Scourfield@cardiff.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: RoblingMR@cardiff.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104646']
1650,32781397,Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial.,"IMPORTANCE


Parenting interventions have been found to normalize cortisol regulation among high-risk children early in development; it is important to investigate the sustainability of these effects and their mechanisms, given the maladaptive outcomes associated with cortisol dysregulation.
OBJECTIVE


To determine whether the Attachment and Biobehavioral Catch-up (ABC) intervention, implemented in infancy, predicts cortisol regulation in middle childhood via changes in early parental sensitivity.
DESIGN


Double blind randomized clinical trial design; started January 2006, the follow-up for this project concluded March 2016.
SETTING


Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city.
PARTICIPANTS


103 parent-child dyads (45.6% female children) with histories of child protective services involvement, randomly assigned to receive ABC (n = 45) or a control intervention (n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years).
INTERVENTIONS


Both conditions included 10-week, in-home, manualized interventions. The experimental condition, ABC, has 3 primary targets for parents: increasing nurturance to child distress, increasing following the child's lead, and decreasing frightening behavior. The control intervention, Developmental Education for Families (DEF), is an adaptation of a program focused on enhancing cognitive and language development.
MAIN OUTCOMES AND MEASURES


Parental sensitivity was coded from a semi-structured interaction task between the parent and child in early childhood. Middle childhood diurnal cortisol slopes were modeled by collecting salivary cortisol samples from children at wake-up and bedtime over the course of 3 consecutive days.
RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002. The indirect effect of ABC on cortisol regulation via sensitivity was significant, β = -0.15, p = .038.
CONCLUSIONS AND RELEVANCE


ABC has an indirect effect on middle childhood diurnal cortisol regulation via parental sensitivity; future research should seek to determine how this enhanced neurobiological regulation relates to children's behavioral, socioemotional, and psychological outcomes.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT02093052.",2020,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","['Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city', ""n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years"", 'middle childhood', '103 parent-child dyads (45.6% female children) with histories of child protective services involvement']","['control intervention, Developmental Education for Families (DEF', 'Attachment and Biobehavioral Catch-up (ABC) intervention', 'ABC', 'control intervention']","['Middle childhood diurnal cortisol slopes', 'cortisol regulation via sensitivity']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0395333,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Garnett', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States. Electronic address: mgarnett@udel.edu.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Stony Brook University, Psychology B Building, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoye', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zajac', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104809']
1651,32801102,"Associations between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life in patients with focal seizures treated with adjunctive eslicarbazepine acetate: Post hoc analyses of clinical trial results.","The relationships between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life (HRQoL) may be important for determining the overall impact of medication therapy on patients with epilepsy. The objectives of these post hoc analyses of the global Phase III 093-0304 trial (NCT00988429, Study 304) of adjunctive eslicarbazepine acetate (ESL) in patients with refractory focal (partial-onset) seizures (FS) were to evaluate associations between seizure severity change, measured by the Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS). The analyses were conducted on the per-protocol population (PPP) of patients who were randomized to a placebo arm (n = 188) or an ESL-active group that included treatment with adjunctive ESL 800 mg once daily (QD; n = 184) or adjunctive ESL 1200 mg QD (n = 175). General linear models (GLM) were used to measure the association between SSQ change and patient baseline characteristics or percentage change in the SSF from baseline. Associations between changes in the SSQ and changes in the QOLIE-31 and MADRS were examined using GLM with patient baseline characteristics as covariates. Subgroup analyses were performed for patients in the ESL-active group and those treated with ESL 800 mg or ESL 1200 mg. Minimal clinically important difference (MCIDs) thresholds were used to assess improvements in SSQ scores. The analyses included 547 per-protocol patients. Patients using 1 antiepileptic drug (AED) at baseline had greater improvements in the SSQ compared with those receiving 2 AEDs (P = 0.0606). Treatment with ESL 1200 mg was significantly associated with clinically meaningful improvements in the SSQ (P = 0.0005). The SSQ improvements were significantly associated with an SSF reduction of ≥75%, compared with no reduction (P < 0.0001). In the PPP and the ESL-active group, SSQ improvements were significantly associated with improvements in QOLIE-31 Total Score (TS; P < 0.0001) and the Seizure Worry (SW; P < 0.0001) and Social Functioning (SF; P = 0.0030) subscales. In the ESL 1200 mg subgroup, SSQ improvements were significantly associated with improvements in QOLIE-31 TS (P < 0.0001) and the SW (P < 0.0001) and Energy/Fatigue (EF; P = 0.0007) subscales. In the ESL 800 mg subgroup, improvements in the SSQ were significantly associated with improvements in QOLIE-31 TS (P = 0.0362) and the SW (P = 0.0241) subscale. There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL. These findings demonstrated that in this clinical trial population, adding ESL to baseline AED therapy had utility for decreasing seizure severity and improving HRQoL. There were no significant associations between changes in seizure severity and changes in depressive symptoms in patients with FS.",2020,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"['patients with refractory focal (partial-onset) seizures (FS', 'patients with epilepsy', 'patients with focal seizures treated with']","['adjunctive eslicarbazepine acetate', 'adjunctive eslicarbazepine acetate (ESL', 'adjunctive ESL 1200\u202fmg QD', 'ESL-active group that included treatment with adjunctive ESL 800', 'ESL 800\u202fmg or ESL', 'ESL', 'placebo']","['SSF reduction', 'SSQ scores', 'seizure frequency, and health-related quality of life (HRQoL', 'seizure frequency, and health-related quality of life', 'SSQ', 'QOLIE-31 Total Score', 'Seizure Worry', 'QOLIE-31 and MADRS', 'QOLIE-31 TS', 'seizure severity and improving HRQoL', 'Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS', 'Social Functioning', 'seizure severity and changes in depressive symptoms', 'Energy/Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.147528,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"[{'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Cramer', 'Affiliation': 'Yale University School of Medicine and Consultant, Houston, TX 77027, United States of America. Electronic address: joyce.cramer@gmail.com.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Colman', 'Affiliation': 'Covance Inc., Suite 3.02, Level 3, Building A, 97 Waterloo Road, Macquarie Corporate Centre, Macquarie Park, New South Wales 2113, Australia. Electronic address: Sam.Colman@covance.com.'}, {'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Anastassopoulos', 'Affiliation': 'Covance Inc., 9801 Washingtonian Blvd., 9th. Floor, Gaithersburg, MD 20878, United States of America. Electronic address: kathryn.anastassopoulos@covance.com.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Grinnell', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Todd.Grinnell@sunovion.com.'}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Mehta', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Darshan.Mehta@sunovion.com.'}, {'ForeName': 'G Rhys', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Gwilym.Williams@sunovion.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107312']
1652,32801130,Risk of Anemia With Metformin Use in Type 2 Diabetes: A MASTERMIND Study.,"OBJECTIVE


To evaluate the association between metformin use and anemia risk in type 2 diabetes, and the time-course for this, in a randomized controlled trial (RCT) and real-world population data.
RESEARCH DESIGN AND METHODS


Anemia was defined as a hemoglobin measure of <11 g/dL. In the RCTs A Diabetes Outcome Progression Trial (ADOPT;  n  = 3,967) and UK Prospective Diabetes Study (UKPDS;  n  = 1,473), logistic regression was used to model anemia risk and nonlinear mixed models for change in hematological parameters. In the observational Genetics of Diabetes Audit and Research in Tayside Scotland (GoDARTS) population ( n  = 3,485), discrete-time failure analysis was used to model the effect of cumulative metformin exposure on anemia risk.
RESULTS


In ADOPT, compared with sulfonylureas, the odds ratio (OR) (95% CI) for anemia was 1.93 (1.10, 3.38) for metformin and 4.18 (2.50, 7.00) for thiazolidinediones. In UKPDS, compared with diet, the OR (95% CI) was 3.40 (1.98, 5.83) for metformin, 0.96 (0.57, 1.62) for sulfonylureas, and 1.08 (0.62, 1.87) for insulin. In ADOPT, hemoglobin and hematocrit dropped after metformin initiation by 6 months, with no further decrease after 3 years. In UKPDS, hemoglobin fell by 3 years in the metformin group compared with other treatments. At years 6 and 9, hemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group. In GoDARTS, each 1 g/day of metformin use was associated with a 2% higher annual risk of anemia.
CONCLUSIONS


Metformin use is associated with early risk of anemia in individuals with type 2 diabetes, a finding consistent across two RCTs and replicated in one real-world study. The mechanism for this early fall in hemoglobin is uncertain, but given the time course, is unlikely to be due to vitamin B 12  deficiency alone.",2020,"At years 6 and 9, hemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group.","['Anemia was defined as a hemoglobin measure of <11 g/dL. In the A Diabetes Outcome Progression Trial (ADOPT;  n  = 3,967) and UK Prospective Diabetes Study (UKPDS;  n  = 1,473) RCTs', 'Type 2 Diabetes', 'individuals with type 2 diabetes']","['Metformin', 'metformin']","['annual risk of anemia', 'Risk of Anemia', 'hemoglobin', 'anemia', 'hemoglobin and hematocrit', 'odds ratio (OR', 'early risk of anemia']","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",,0.042343,"At years 6 and 9, hemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group.","[{'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Donnelly', 'Affiliation': 'Population Health & Genomics, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Dennis', 'Affiliation': 'Institute of Biomedical & Clinical Science, University of Exeter Medical School, Royal Devon & Exeter Hospital, Exeter, U.K.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Institute of Cardiovascular and Medicine Sciences, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hattersley', 'Affiliation': 'Institute of Biomedical & Clinical Science, University of Exeter Medical School, Royal Devon & Exeter Hospital, Exeter, U.K.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Institute of Cardiovascular and Medicine Sciences, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Pearson', 'Affiliation': 'Population Health & Genomics, School of Medicine, University of Dundee, Dundee, U.K. e.z.pearson@dundee.ac.uk.'}]",Diabetes care,['10.2337/dc20-1104']
1653,32804950,Protection conferred by typhoid fever against recurrent typhoid fever in urban Kolkata.,"We evaluated the protection conferred by a first documented visit for clinical care of typhoid fever against recurrent typhoid fever prompting a visit. This study takes advantage of multi-year follow-up of a population with endemic typhoid participating in a cluster-randomized control trial of Vi capsular polysaccharide typhoid vaccine in Kolkata, India. A population of 70,566 individuals, of whom 37,673 were vaccinated with one dose of either Vi vaccine or a control (Hepatitis A) vaccine, were observed for four years. Surveillance detected 315 first typhoid visits, among whom 4 developed subsequent typhoid, 3 due to reinfection, defined using genomic criteria and corresponding to -124% (95% CI: -599, 28) protection by the initial illness. Point estimates of protection conferred by an initial illness were negative or negligible in both vaccinated and non-vaccinated subjects, though confidence intervals around the point estimates were wide. These data provide little support for a protective immunizing effect of clinically treated typhoid illness, though modest levels of protection cannot be excluded.",2020,"Point estimates of protection conferred by an initial illness were negative or negligible in both vaccinated and non-vaccinated subjects, though confidence intervals around the point estimates were wide.","['599', 'urban Kolkata', 'A population of 70,566 individuals, of whom 37,673 were vaccinated with one dose of either', 'population with endemic typhoid participating in a cluster-randomized control trial of Vi capsular polysaccharide typhoid vaccine in Kolkata, India']",['Vi vaccine or a control (Hepatitis A) vaccine'],[],"[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0041469', 'cui_str': 'Typhoid vaccine'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019159', 'cui_str': 'Viral hepatitis, type A'}]",[],70566.0,0.430829,"Point estimates of protection conferred by an initial illness were negative or negligible in both vaccinated and non-vaccinated subjects, though confidence intervals around the point estimates were wide.","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Im', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Md Taufiqul', 'Initials': 'MT', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Ahmmed', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chon', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Ashraful Islam', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Sur', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, West Bengal, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Kanungo', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, West Bengal, India.'}, {'ForeName': 'Shanta', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, West Bengal, India.'}, {'ForeName': 'Sujit K', 'Initials': 'SK', 'LastName': 'Bhattacharya', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, West Bengal, India.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Dougan', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Holt', 'Affiliation': 'Department of Infectious Diseases, Central Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Marks', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008530']
1654,32809136,Conservative oxygen therapy for mechanically ventilated adults with suspected hypoxic ischaemic encephalopathy.,"PURPOSE


Liberal use of oxygen may contribute to secondary brain injury in patients with hypoxic-ischaemic encephalopathy (HIE). However, there are limited data on the effect of different oxygen regimens on survival and neurological disability in HIE patients.
METHODS


We undertook a post-hoc analysis of the 166 patients with suspected HIE enrolled in a trial comparing conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary endpoint for the current analysis was death or unfavourable neurological outcome at day 180. Key secondary outcomes were day 180 mortality, and cause-specific mortality.
RESULTS


Patients with HIE allocated to conservative oxygen spent less time in the ICU with an SpO 2  ≥ 97% (26 h [interquartile range (IQR) 13-45 vs. 35 h [IQR 19-70], absolute difference, 9 h; 95% CI - 21.4 to 3.4). A total of 43 of 78 patients (55.1%) assigned to conservative oxygen and 49 of 72 patients (68.1%) assigned to usual oxygen died or had an unfavourable neurological outcome at day 180; odds ratio 0.58; 95% CI 0.3-1.12; P = 0.1 adjusted odds ratio 0.54; 95% CI 0.23-1.26; P = 0.15. A total of 37 of 86 patients (43%) assigned to conservative oxygen and 46 of 78 (59%) assigned to usual oxygen had died by day 180; odds ratio 0.53; 95% CI 0.28-0.98; P = 0.04; adjusted odds ratio 0.56; 95% CI 0.25-1.23; P = 0.15. Cause-specific mortality was similar by treatment group.
CONCLUSIONS


Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180. The potential for important benefit or harm from conservative oxygen therapy in HIE patients is not excluded by these data.",2020,"CONCLUSIONS


Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180.","['mechanically ventilated adults with suspected hypoxic ischaemic encephalopathy', '1000 mechanically ventilated ICU patients', '166 patients with suspected HIE enrolled in a trial comparing', 'Patients with HIE', 'HIE patients', 'patients with hypoxic-ischaemic encephalopathy (HIE']","['conservative oxygen therapy with usual oxygen therapy', 'Conservative oxygen therapy']","['day 180 mortality, and cause-specific mortality', 'survival and neurological disability', 'death or unfavourable neurological outcomes', 'Cause-specific mortality', 'death or unfavourable neurological outcome']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1000.0,0.358589,"CONCLUSIONS


Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. paul.young@ccdhb.org.nz.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Deane', 'Affiliation': 'University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'Division of Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Freebairn', 'Affiliation': 'Intensive Care Unit, Hawkes Bay Hospital, Hastings, New Zealand.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'King', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Linke', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06196-y']
1655,32668114,Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury.,"BACKGROUND


Acute kidney injury is common in critically ill patients, many of whom receive renal-replacement therapy. However, the most effective timing for the initiation of such therapy remains uncertain.
METHODS


We conducted a multinational, randomized, controlled trial involving critically ill patients with severe acute kidney injury. Patients were randomly assigned to receive an accelerated strategy of renal-replacement therapy (in which therapy was initiated within 12 hours after the patient had met eligibility criteria) or a standard strategy (in which renal-replacement therapy was discouraged unless conventional indications developed or acute kidney injury persisted for >72 hours). The primary outcome was death from any cause at 90 days.
RESULTS


Of the 3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group). Of these patients, renal-replacement therapy was performed in 1418 (96.8%) in the accelerated-strategy group and in 903 (61.8%) in the standard-strategy group. At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92). Among survivors at 90 days, continued dependence on renal-replacement therapy was confirmed in 85 of 814 patients (10.4%) in the accelerated-strategy group and in 49 of 815 patients (6.0%) in the standard-strategy group (relative risk, 1.74; 95% CI, 1.24 to 2.43). Adverse events occurred in 346 of 1503 patients (23.0%) in the accelerated-strategy group and in 245 of 1489 patients (16.5%) in the standard-strategy group (P<0.001).
CONCLUSIONS


Among critically ill patients with acute kidney injury, an accelerated renal-replacement strategy was not associated with a lower risk of death at 90 days than a standard strategy. (Funded by the Canadian Institutes of Health Research and others; STARRT-AKI ClinicalTrials.gov number, NCT02568722.).",2020,"At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92).","['critically ill patients with severe acute kidney injury', 'critically ill patients with acute kidney injury', 'Acute Kidney Injury', 'critically ill patients, many of whom receive renal-replacement therapy', '3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group']","['standard strategy (in which renal-replacement therapy', 'Renal-Replacement Therapy', 'accelerated strategy of renal-replacement therapy']","['Adverse events', 'death', 'death from any cause at 90 days', 'lower risk of death', 'renal-replacement therapy']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",3019.0,0.2899,"At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Neill K J', 'Initials': 'NKJ', 'LastName': 'Adhikari', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Dreyfuss', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Gallagher', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Gaudry', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hoste', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Neyra', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Alistair D', 'Initials': 'AD', 'LastName': 'Nichol', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Schneider', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Orla M', 'Initials': 'OM', 'LastName': 'Smith', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Thomé', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Vaara', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Weir', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Amanda Y', 'Initials': 'AY', 'LastName': 'Wang', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}]",The New England journal of medicine,['10.1056/NEJMoa2000741']
1656,32668323,A randomized controlled trial of lung ultrasound-guided therapy in heart failure (CLUSTER-HF study).,"BACKGROUND


Lung ultrasound (LUS) has emerged as a new tool for the evaluation of congestion in heart failure (HF); incorporation of LUS during follow-up may detect congestion earlier and prompt interventions to prevent hospitalizations. The aim of this study was to test the hypothesis that the incorporation of LUS during follow-up of patients with HF may reduce the rate of adverse events compared with usual care.
METHODS


In this single-blinded, randomized controlled trial, patients were randomized into an LUS-guided arm or control arm. Patients were followed in 4 prespecified visits during a 6-month period. LUS was performed in every patient visit in both groups; however, LUS results were available for the treating physician only in the LUS group. The primary outcome was the composite of urgent HF visits, rehospitalization for worsening HF, and death from any cause.
RESULTS


One hundred twenty-six patients were randomized to either LUS (n = 63) or control (n = 63) (age 62.5 ± 10 years, median left ventricular ejection fraction 31%). The primary end point occurred in 30 (47.6%) patients in the control group and 20 (31.7%) patients in the LUS group (P = .041). LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001). No significant differences in rehospitalizations for HF or death were found.
CONCLUSIONS


Incorporation of LUS into clinical follow-up of patients with HF significantly reduced the risk of urgent visits for worsening HF.",2020,"LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001).",['One hundred twenty-six patients'],"['LUS-guided arm or control arm', 'lung ultrasound-guided therapy', 'Lung ultrasound (LUS', 'LUS']","['rate of adverse events', 'urgent HF visits', 'rehospitalizations for HF or death', 'composite of urgent HF visits, rehospitalization for worsening HF, and death from any cause', 'risk of urgent visits']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",126.0,0.114217,"LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001).","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Araiza-Garaygordobil', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico. Electronic address: dargaray@gmail.com.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Gopar-Nieto', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Martinez-Amezcua', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Cabello-López', 'Affiliation': 'Centro Médico Nacional ""Siglo XXI,"" Instituto Mexicano del Seguro Social, Mexico City, Mexico.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Alanis-Estrada', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Luna-Herbert', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'González-Pacheco', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Cynthia Paola', 'Initials': 'CP', 'LastName': 'Paredes-Paucar', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Martinez Daniel', 'Initials': 'MD', 'LastName': 'Sierra-Lara', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Briseño-De la Cruz', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Rodriguez-Zanella', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Martinez-Rios', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Arias-Mendoza', 'Affiliation': 'Instituto Nacional de Cardiología ""Ignacio Chávez,"", Mexico City, Mexico.'}]",American heart journal,['10.1016/j.ahj.2020.06.003']
1657,32763548,Effect of psychotropic drugs on cortical excitability of patients with major depressive disorders: A transcranial magnetic stimulation study.,"Transcranial magnetic stimulation (TMS) can be used to evaluate the effects of pharmacological interventions. The aim of this study was to assess the impact of the selective serotonin reuptake inhibitor, sertraline, and the atypical antipsychotic drugs quetiapine and olanzapine, on cortical excitability in unmedicated patients with major depressive disorder (MDD). The study included 45 medication-free MDD patients diagnosed according to DSM V. They were divided randomly into three groups who received a single oral dose of one of the three drugs sertraline (50 mg), quetiapine (100 mg) and olanzapine (10 mg). Psychological evaluation was conducted using the Mini-Mental State Examination (MMSE) and Beck Depression Inventory Scale (BDI). Resting and active motor thresholds (rMT and aMT) together with contralateral and ipsilateral cortical silent periods (cSP, and iSP) were measured for each participant before and at the time of maximum concentration of drug intake. There was significant increase in excitability of motor cortex after sertraline without changes in GABA B  neurotransmission. Quetiapine and olanzapine potentiated inhibitory GABA B  neurotransmission (prolongation of cSP); olanzapine additionally prolonged the iSP. Thus TMS can differentiate between the impact of different psychotropic drugs on excitatory and inhibitory transmission in motor cortex.",2020,Quetiapine and olanzapine potentiated inhibitory GABA B  neurotransmission (prolongation of cSP); olanzapine additionally prolonged the iSP.,"['unmedicated patients with major depressive disorder (MDD', 'patients with major depressive disorders', '45 medication-free MDD patients diagnosed according to DSM V']","['olanzapine', 'sertraline', 'Quetiapine and olanzapine', 'Transcranial magnetic stimulation (TMS', 'psychotropic drugs', 'sertraline, and the atypical antipsychotic drugs quetiapine and olanzapine', 'quetiapine']","['cortical excitability', 'Mini-Mental State Examination (MMSE) and Beck Depression Inventory Scale (BDI', 'excitability of motor cortex', 'Resting and active motor thresholds (rMT and aMT) together with contralateral and ipsilateral cortical silent periods (cSP, and iSP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0063517', 'cui_str': 'indopan'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0010701', 'cui_str': 'Phyllodes tumour'}]",,0.0198595,Quetiapine and olanzapine potentiated inhibitory GABA B  neurotransmission (prolongation of cSP); olanzapine additionally prolonged the iSP.,"[{'ForeName': 'Eman M', 'Initials': 'EM', 'LastName': 'Khedr', 'Affiliation': 'Neuropsychiatry Department, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: emankhedr99@yahoo.com.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Elserogy', 'Affiliation': 'Neuropsychiatry Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Fawzy', 'Affiliation': 'Neuropsychiatry Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Abdelrahman', 'Affiliation': 'Neuropsychiatry Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Amr M', 'Initials': 'AM', 'LastName': 'Galal', 'Affiliation': 'Neuropsychiatry Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mostafa M', 'Initials': 'MM', 'LastName': 'Noaman', 'Affiliation': 'Neuropsychiatry Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",Psychiatry research,['10.1016/j.psychres.2020.113287']
1658,32763623,Effect of exogenous progesterone administration on smoking topography.,"INTRODUCTION


Progesterone has been implicated as protective against drug taking behaviors, including combustible cigarettes. While prior research indicates higher endogenous progesterone levels are associated with a reduction in smoking intensity (as measured by smoking topography), it is unknown if exogenous delivery of progesterone may have the same effect.
METHODS


This double-blind, counterbalanced, cross-over randomized trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives. After overnight abstinence participants attended two topography lab sessions. One lab session was conducted during progesterone (200 mg twice per day) treatment and the other was during placebo treatment. Analyses included linear mixed effect models to examine the effect of exogenous progesterone administration and endogenous progesterone values on topography outcomes.
RESULTS


Participants (n = 43) were 23.8 (standard deviation [SD] ± 4.5) years old, smoked 10.5 (SD ± 3.7) cigarettes per day. Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL (95% confidence interval [CI]: -536, -65; p-value = 0.01) with additional trends indicating possible reductions in the number of puffs, average puff volume, and average flow. There were no significant effects of endogenous progesterone on smoking topography outcomes.
CONCLUSIONS


Progesterone administration has the potential to reduce smoking intensity after overnight abstinence in women of reproductive age. Additional research is needed to explore how this may relate to smoking cessation outcomes in women of reproductive age.",2020,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","['Participants (n\xa0=\xa043) were 23.8 (standard deviation [SD]\xa0±\xa04.5) years old, smoked 10.5 (SD\xa0±\xa03.7) cigarettes per day', 'trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives', 'women of reproductive age']","['progesterone', 'exogenous progesterone', 'Progesterone', 'placebo']","['cumulative puff volume', 'number of puffs, average puff volume, and average flow', 'smoking intensity', 'smoking topography']","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",43.0,0.178407,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States. Electronic address: aliciaallen@arizona.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106570']
1659,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND


Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS


23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS


After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION


Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
1660,32768569,The effect of conservative oxygen therapy on systemic biomarkers of oxidative stress in critically ill patients.,"BACKGROUND


Supplemental oxygen is delivered to critically ill patients who require mechanical ventilation. Oxidative stress is a potential complication of oxygen therapy, resulting in damage to essential biomolecules such as proteins, lipids, and nucleic acids. Whether plasma levels of oxidative stress biomarkers vary based on how liberally oxygen therapy is applied during mechanical ventilation is unknown.
METHODS


We carried out an oxidative stress substudy nested within a large multi-centre randomized controlled trial in which critically ill adults were randomized to receive either conservative oxygen therapy or standard oxygen therapy. Blood samples were collected at enrolment, and daily thereafter for up to three days. The antioxidant ascorbate (vitamin C) was assessed using HPLC with electrochemical detection and protein oxidation using a sensitive protein carbonyl ELISA. We also assessed whether critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers.
RESULTS


A total of 125 patients were included. Mean ascorbate concentrations decreased over time (from 25 ± 9 μmol/L to 14 ± 2 μmol/L, p < 0.001), however, there was no significant difference between the conservative oxygen group and standard care (p = 0.2), despite a significantly lower partial pressure of oxygen (PaO 2 ) in the conservative oxygen group (p = 0.03). Protein carbonyl concentrations increased over time (from 208 ± 30 μmol/L to 249 ± 29 μmol/L; p = 0.016), however, there was no significant difference between the conservative and standard oxygen groups (p = 0.3). Patients with sepsis had significantly higher protein carbonyl concentrations than the other critically ill patients (293 ± 92 μmol/L vs 184 ± 24 μmol/L, p = 0.03). Within the septic subgroup, there were no significant differences in protein carbonyl concentrations between the two interventions (p = 0.4).
CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy. Patients with sepsis exhibited elevated protein carbonyls compared with the other critically ill patients implying increased oxidative stress in this patient subgroup.",2020,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","['critically ill adults', 'critically ill patients', 'critically ill ventilated patients', 'critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers', 'A total of 125 patients were included', 'critically ill patients who require mechanical ventilation']","['conservative oxygen therapy', 'antioxidant ascorbate (vitamin C', 'Conservative oxygen therapy', 'standard oxygen therapy', 'conservative oxygen therapy or standard oxygen therapy']","['Mean ascorbate concentrations', 'systemic biomarkers of oxidative stress', 'oxidative stress', 'Blood samples', 'protein carbonyl concentrations', 'Protein carbonyl concentrations', 'systemic markers of oxidative stress', 'partial pressure of oxygen (PaO 2 ']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}]",125.0,0.329893,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","[{'ForeName': 'Anitra C', 'Initials': 'AC', 'LastName': 'Carr', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand. Electronic address: anitra.carr@otago.ac.nz.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Spencer', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Judd', 'Affiliation': 'Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehrtens', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Parker', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Stockwell', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, Australia; College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.06.018']
1661,32769878,A phase 3 double-blind randomized (CONSORT-compliant) study of azilsartan medoxomil compared to valsartan in Chinese patients with essential hypertension.,"BACKGROUND


Azilsartan medoxomil (AZL-M), an angiotensin II receptor blocker, has a well-characterized efficacy and safety profile in patients with hypertension. AZL-M is approved for use in over 40 countries globally; however, it is not yet approved in China. Therefore, a phase 3 registration study to assess the efficacy (antihypertensive effect), safety, and tolerability of AZL-M compared with valsartan in Chinese patients with essential hypertension was undertaken.
METHODS


This multicenter, double-blind, randomized, 8-week phase 3 study compared AZL-M with valsartan in Chinese patients aged ≥18 years with essential hypertension. Endpoints included change from baseline to week 8 in trough sitting clinic systolic blood pressure (scSBP) and ambulatory blood pressure monitoring parameters.
RESULTS


Overall, 612 patients (mean age, 57.1 years; 57.5% male) were randomized to AZL-M 80 mg (n = 209), AZL-M 40 mg (n = 199), or valsartan 160 mg (n = 204). Baseline mean scSBP was similar in all groups (157.9-158.5 mm Hg). The mean reduction in trough scSBP from baseline to week 8 was significantly greater with AZL-M 80 mg than with valsartan (-24.2 vs -20.6 mm Hg; P = .010), and noninferior with AZL-M 40 mg versus valsartan (-22.5 vs -20.6 mm Hg; P = .184). Mean reduction in 24-hour mean systolic blood pressure (n = 257) was significantly greater with both AZL-M 80 mg (-17.0 mm Hg; P < .001) and AZL-M 40 mg (-14.7 mm Hg; P = .014) than with valsartan (-9.4 mm Hg). Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate. Dizziness was the most frequent treatment-related treatment-emergent adverse events (AZL-M 80 mg, 1.9%; AZL-M 40 mg, 1.5%; valsartan, 1.0%). The safety and tolerability of AZL-M were comparable with valsartan.
CONCLUSIONS


AZL-M was noninferior to valsartan at the 40-mg dose and superior to valsartan at the 80-mg dose in reducing trough scSBP, and showed acceptable safety-consistent with the AZL-M safety profile in other populations-in Chinese adults with hypertension.
TRIAL REGISTRATION NUMBER


NCT02480764.",2020,Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate.,"['612 patients (mean age, 57.1 years; 57.5% male', 'Chinese patients with essential hypertension was undertaken', 'Chinese patients with essential hypertension', 'patients with hypertension', 'Chinese patients aged ≥18 years with essential hypertension', 'Chinese adults with hypertension']","['AZL-M', 'valsartan', 'AZL-M with valsartan', 'AZL-M 40\u200amg (n\u200a=\u200a199), or valsartan', 'azilsartan medoxomil', 'Azilsartan medoxomil (AZL-M']","['Baseline mean scSBP', 'mean reduction in trough scSBP', 'efficacy (antihypertensive effect), safety, and tolerability', 'safety and tolerability of AZL-M', 'Mean reduction in 24-hour mean systolic blood pressure', 'Dizziness', 'trough sitting clinic systolic blood pressure (scSBP) and ambulatory blood pressure monitoring parameters']","[{'cui': 'C4517834', 'cui_str': '612'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2698291', 'cui_str': 'azilsartan medoxomil'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C2979834', 'cui_str': 'azilsartan medoxomil 40 MG'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2698291', 'cui_str': 'azilsartan medoxomil'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",612.0,0.157334,Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate.,"[{'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Zhanquan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, People's Hospital of Liaoning Province, Liaoning.""}, {'ForeName': 'Zeqi', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of NanChang University, Jiangxi.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiology, the Affiliated Hospital of Xuzhou Medical College.'}, {'ForeName': 'Chengchun', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiology, Southeast University, Zhongda Hospital, Jiangsu.'}, {'ForeName': 'Zhuhua', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': ""Department of Cardiology, Tianjin People's Hospital, Tianjin.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Hebei Cangzhou Central Hospital, Hebei.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Long', 'Affiliation': 'Department of Cardiology, Nanjing Medical University Affiliated 2nd Hospital, Jiangsu, China.'}, {'ForeName': 'Michie', 'Initials': 'M', 'LastName': 'Hisada', 'Affiliation': 'Global Patient Safety Evaluation, Takeda Development Center Americas, Inc., Deerfield, IL.'}, {'ForeName': 'Jingtao', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Statistics and Quantitative Sciences, Takeda Development Center Americas, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Clinical Science, Takeda Development Center Asia, Pte. Ltd., Shanghai, China.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}]",Medicine,['10.1097/MD.0000000000021465']
1662,32776237,Type 2 diabetes remission: 2 year within-trial and lifetime-horizon cost-effectiveness of the Diabetes Remission Clinical Trial (DiRECT)/Counterweight-Plus weight management programme.,"AIMS/HYPOTHESIS


Approximately 10% of total healthcare budgets worldwide are spent on treating diabetes and its complications, and budgets are increasing globally because of ageing populations and more expensive second-line medications. The aims of the study were to estimate the within-trial and lifetime cost-effectiveness of the weight management programme, which achieved 46% remissions of type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT).
METHODS


Within-trial analysis assessed costs of the Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet), along with glucose-lowering and antihypertensive medications, and all routine healthcare contacts. Lifetime cost per quality-adjusted life-year (QALY) was estimated according to projected durations of remissions, assuming continued relapse rates as seen in year 2 of DiRECT and consequent life expectancy, quality of life and healthcare costs.
RESULTS


Mean total 2 year healthcare costs for the intervention and control groups were £3036 and £2420, respectively: an incremental cost of £616 (95% CI -£45, £1269). Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314). Net remission at 2 years was 32.3% (95% CI 23.5%, 40.3%), and cost per remission achieved was £1907 (lower 95% CI: intervention dominates; upper 95% CI: £4212). Over a lifetime horizon, the intervention was modelled to achieve a mean 0.06 (95% CI 0.04, 0.09) QALY gain for the DiRECT population and mean total lifetime cost savings per participant of £1337 (95% CI £674, £2081), with the intervention becoming cost-saving within 6 years.
CONCLUSIONS/INTERPRETATION


Incorporating the lifetime healthcare cost savings due to periods of remission from diabetes and its complications, the DiRECT intervention is predicted to be both more effective (QALY gain) and cost-saving in adults with type 2 diabetes compared with standard care. This conclusion appears robust to various less favourable model scenarios, providing strong evidence that resources could be shifted cost-effectively to support achieving remissions with the DiRECT intervention.
TRIAL REGISTRATION


ISRCTN03267836 Graphical abstract.",2020,"Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314).","['type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT', 'adults with type 2 diabetes']","['DiRECT)/Counterweight-Plus weight management programme', 'Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet', 'weight management programme']","['life expectancy, quality of life and healthcare costs', 'healthcare costs', 'mean total lifetime cost savings', 'Mean total 2\xa0year healthcare costs', 'Net remission', 'cost per remission', 'Lifetime cost per quality-adjusted life-year (QALY', 'reduced oral glucose-lowering medications']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]","[{'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0931155,"Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314).","[{'ForeName': 'Yiqiao', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McCombie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK.'}, {'ForeName': 'C Martina', 'Initials': 'CM', 'LastName': 'Messow', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Grieve', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Wilma S', 'Initials': 'WS', 'LastName': 'Leslie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Translational and Clinical Research Institute, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK. mike.lean@glasgow.ac.uk.'}]",Diabetologia,['10.1007/s00125-020-05224-2']
1663,32777710,Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial.,"OBJECTIVES


To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.
STUDY DESIGN


In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.
MAIN OUTCOME MEASURES


The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.
FINDINGS


We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts.
INTERPRETATION


The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","['39,446 women in intervention (N\xa0=\xa020,264) and control clusters (N\xa0=\xa019,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively', 'mothers with pre-eclampsia in health facilities', 'recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization', 'pre-eclampsia (CLIP) in Pakistan', 'women with preeclampsia']","['Community-level interventions', 'CLIP intervention']","['late neonatal deaths', 'neonatal morbidity', 'outcome rates', 'maternal death', 'reduction in stillbirths', 'composite of maternal, fetal and newborn mortality and major morbidity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0455987', 'cui_str': 'Late neonatal death'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",39446.0,0.261501,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","[{'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hoodbhoy', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan; Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto, ON M5G 2L3, Canada. Electronic address: zulfiqar.bhutta@aku.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'the CLIP Pakistan Trial Working Group (Table S1).'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.011']
1664,32601378,COVID-19 among fit patients with CLL treated with venetoclax-based combinations.,,2020,,['patients with CLL treated with venetoclax-based combinations'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],[],,0.0235184,,"[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Fürstenau', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany. moritz.fuerstenau@uk-koeln.de.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Langerbeins', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'De Silva', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'von Tresckow', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Simon', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hohloch', 'Affiliation': 'Department of Internal Medicine, Hematology and Medical Oncology, Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'Droogendijk', 'Affiliation': 'Division of Hematology and Oncology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'van der Klift', 'Affiliation': 'Division of Hematology and Oncology, Amphia Ziekenhuis Breda, Breda, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'van der Spek', 'Affiliation': 'Department of Internal Medicine, Ziekenhuis Rijnstate, Arnhem, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Illmer', 'Affiliation': 'BAG Freiberg-Richter, Jacobasch, Wolf, Illmer, Dresden, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Schöttker', 'Affiliation': 'Hämatologisch-onkologische Schwerpunktpraxis Würzburg, Würzburg, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Clemens M', 'Initials': 'CM', 'LastName': 'Wendtner', 'Affiliation': 'Department of Hematology, Oncology, Immunology, Palliative Care, Infectious Diseases and Tropical Medicine, German CLL Study Group, Munich Clinic Schwabing, Munich, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Carsten U', 'Initials': 'CU', 'LastName': 'Niemann', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gregor', 'Affiliation': 'Division of Hematology, Cantonal Hospital of Lucerne, Lucerne, Switzerland.'}, {'ForeName': 'Arnon P', 'Initials': 'AP', 'LastName': 'Kater', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}]",Leukemia,['10.1038/s41375-020-0941-7']
1665,32811690,"Corrigendum to ""Influence of front-of-pack labelling and regulated nutrition claims on consumers' perceptions of product healthfulness and purchase intentions: A randomized controlled trial"" [Appetite 149 (1 June 2020) 104629].",,2020,,"[""consumers' perceptions of product healthfulness and purchase intentions""]",['pack labelling and regulated nutrition claims'],[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]",[],,0.0741049,,"[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Franco-Arellano', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Vanderlee', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada; School of Public Health and Health Systems, University of Waterloo, 200 University Avenue West, Waterloo, Ontario, N2L 3G1, Canada.""}, {'ForeName': 'Mavra', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Oh', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada; Faculty of Law, University of Ottawa, 57 Louis Pasteur St, Ottawa, Ontario, K1N 6N5, Canada.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""L'Abbé"", 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada. Electronic address: mary.labbe@utoronto.ca.""}]",Appetite,['10.1016/j.appet.2020.104809']
1666,32811700,Results of an open label feasibility study of sodium valproate in people with McArdle disease.,"McArdle disease results from a lack of muscle glycogen phosphorylase in skeletal muscle tissue. Regenerating skeletal muscle fibres can express the brain glycogen phosphorylase isoenzyme. Stimulating expression of this enzyme could be a therapeutic strategy. Animal model studies indicate that sodium valproate (VPA) can increase expression of phosphorylase in skeletal muscle affected with McArdle disease. This study was designed to assess whether VPA can modify expression of brain phosphorylase isoenzyme in people with McArdle disease. This phase II, open label, feasibility pilot study to assess efficacy of six months treatment with VPA (20 mg/kg/day) included 16 people with McArdle disease. Primary outcome assessed changes in VO 2 peak during an incremental cycle test. Secondary outcomes included: phosphorylase enzyme expression in post-treatment muscle biopsy, total distance walked in 12 min, plasma lactate change (forearm exercise test) and quality of life (SF36). Safety parameters. 14 participants completed the trial, VPA treatment was well tolerated; weight gain was the most frequently reported drug-related adverse event. There was no clinically meaningful change in any of the primary or secondary outcome measures including: VO 2 peak, 12 min walk test and muscle biopsy to look for a change in the number of phosphorylase positive fibres between baseline and 6 months of treatment. Although this was a small open label feasibility study, it suggests that a larger randomised controlled study of VPA, may not be worthwhile.",2020,"There was no clinically meaningful change in any of the primary or secondary outcome measures including: VO 2 peak, 12 min walk test and muscle biopsy to look for a change in the number of phosphorylase positive fibres between baseline and 6 months of treatment.","['16 people with McArdle disease', 'people with McArdle disease']","['VPA', 'sodium valproate (VPA', 'sodium valproate']","['tolerated; weight gain', 'phosphorylase enzyme expression in post-treatment muscle biopsy, total distance walked in 12\xa0min, plasma lactate change (forearm exercise test) and quality of life (SF36', 'VO 2 peak, 12\xa0min walk test and muscle biopsy to look for a change in the number of phosphorylase positive fibres', 'changes in VO 2 peak during an incremental cycle test']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017924', 'cui_str': 'Glycogen storage disease, type V'}]","[{'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0037567', 'cui_str': 'Valproate sodium'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0017916', 'cui_str': 'alpha-Glucan Phosphorylases'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",16.0,0.0633946,"There was no clinically meaningful change in any of the primary or secondary outcome measures including: VO 2 peak, 12 min walk test and muscle biopsy to look for a change in the number of phosphorylase positive fibres between baseline and 6 months of treatment.","[{'ForeName': 'Renata S', 'Initials': 'RS', 'LastName': 'Scalco', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom; CAPES Foundation, Ministry of Education, Brazil.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Stemmerik', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Nicoline', 'Initials': 'N', 'LastName': 'Løkken', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Christoffer R', 'Initials': 'CR', 'LastName': 'Vissing', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Madsen', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Zuzanna', 'Initials': 'Z', 'LastName': 'Michalak', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Pattni', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Godfrey', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom; Centre for Human Performance, Exercise and Rehabilitation, Brunel University London, Uxbridge, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Samandouras', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd., HP7 9EN, United Kingdom.'}, {'ForeName': 'Janice L', 'Initials': 'JL', 'LastName': 'Holton', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krag', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Haller', 'Affiliation': 'Department of Neurology, The University of Texas Southwestern Medical Center and Neuromuscular Centre, Institute for exercise and environmental medicine, Dallas, Texas, 75231, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sewry', 'Affiliation': 'RJAH Orthopaedic Hospital NHS Foundation Trust Oswestry, United Kingdom.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Wigley', 'Affiliation': 'Great Ormond Street Hospital, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Ros', 'Initials': 'R', 'LastName': 'Quinlivan', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom. Electronic address: r.quinlivan@ucl.ac.uk.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2020.04.009']
1667,32814120,Development and preliminary testing of a technology-enhanced intervention to improve energy intake regulation in children.,"Interventions designed to improve children's self-regulation of energy intake have yielded mixed results. We tested the efficacy of a technology-enhanced intervention designed to teach children to eat in response to internal hunger and fullness cues. Thirty-two children (mean age 4.9 ± 0.8 y) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions, each scheduled approximately 1 week apart. The intervention was conducted across weeks 4-7 in small groups focused on teaching children how food travels through the body and how to respond to hunger and fullness signals. Children's short-term energy compensation, a measure of intake regulation, was collected at baseline and follow-up using a preloading protocol. Twenty-five minutes prior to receiving a standardized test meal, children consumed a low-energy (3 kcal) or high-energy (150 kcal) preload beverage, presented in random order at baseline and follow-up. Knowledge of intervention concepts was also assessed at baseline and follow-up. Linear mixed models were used to examine changes in short-term energy compensation and knowledge from baseline to follow-up. Knowledge related to the intervention improved from baseline to follow-up (3.5 ± 0.3 to 7.0 ± 0.3 correct responses out of a possible 10; P < 0.001). Children's energy compensation also improved from baseline to follow-up, as evidenced by a time-by-preload condition interaction (P = 0.02). However, this improvement was driven by boys who increased the adjustment for beverage energy content from baseline to follow-up (P = 0.04). Girls showed no change in energy compensation with the intervention (P = 0.58). The overall increase in knowledge, paired with the improvement in energy compensation in boys, suggests that this technology-enhanced intervention may be efficacious for some children. Further research is needed to determine whether boys and girls will benefit from different, personalized intervention strategies for obesity prevention.",2020,Girls showed no change in energy compensation with the intervention (P = 0.58).,"['Thirty-two children (mean age 4.9\u202f±\u202f0.8\u202fy) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions', 'children']","['technology-enhanced intervention', 'standardized test meal, children consumed a low-energy (3\u202fkcal) or high-energy (150\u202fkcal) preload beverage']","['energy compensation', ""Children's energy compensation""]","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",32.0,0.0189846,Girls showed no change in energy compensation with the intervention (P = 0.58).,"[{'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Reigh', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 110 Chandlee Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 226 Henderson Building, University Park, PA, 16802, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'The Pennsylvania State University, Center for Childhood Obesity Research and Department of Nutritional Sciences. 129 Noll Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Department of Pediatrics. 12631 East 17th Avenue, Mail Stop F-561, Academic Office Building, Room 2609; Aurora, CO, 80045, USA.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': 'The Pennsylvania State University, Departments of Nutritional Sciences and Food Science. 321 Chandlee Laboratory, University Park, PA, 16802, USA. Electronic address: klk37@psu.edu.'}]",Appetite,['10.1016/j.appet.2020.104830']
1668,32819447,"Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk.","BACKGROUND


Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM).
METHODS


This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10 -5  sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk.
RESULTS


After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR.
CONCLUSION


These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02136134 . Registered 12 May 2014.",2020,"D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk.","['patients with relapsed or refractory MM (RRMM', 'Multiple myeloma (MM) patients with high cytogenetic risk']","['Daratumumab, bortezomib, and dexamethasone', 'bortezomib/dexamethasone (Vd) alone', 'bortezomib/dexamethasone']","['progression-free survival (PFS', 'higher rates of MRD negativity and sustained MRD negativity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",498.0,0.142329,"D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk.","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. k.weisel@uke.de.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lentzsch', 'Affiliation': 'Division of Hematology/Oncology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Unite de Genomique du Myelome, CHU Rangueil, Toulouse, France.'}, {'ForeName': 'Tomer M', 'Initials': 'TM', 'LastName': 'Mark', 'Affiliation': 'Department of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Spicka', 'Affiliation': 'Clinical Department of Haematology, 1st Medical Department, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Masszi', 'Affiliation': 'László Hospital, 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Lauri', 'Affiliation': 'Department of Hematology, Sunderbyn Hospital, Luleå, Sweden.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bosi', 'Affiliation': 'Department of Hematology, Careggi Hospital and University of Florence, Firenze, Italy.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Irmandade Da Santa Casa De Misericordia De São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': '""Seràgnoli"" Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Je-Jung', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Jeollanamdo, South Korea.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nooka', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne, St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Munder', 'Affiliation': 'University Medical Center of the Johannes Gutenberg University, Third Department of Medicine, Mainz, Germany.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Royal Adelaide Hospital, North Terrace, Adelaide, Australia.'}, {'ForeName': 'Wolney', 'Initials': 'W', 'LastName': 'Barreto', 'Affiliation': 'University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, University of Milan, Milan, Italy.'}, {'ForeName': 'Chang-Ki', 'Initials': 'CK', 'LastName': 'Min', 'Affiliation': ""Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Asher A', 'Initials': 'AA', 'LastName': 'Chanan-Khan', 'Affiliation': 'Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Horvath', 'Affiliation': 'Royal Adelaide Hospital, North Terrace, Adelaide, Australia.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Capra', 'Affiliation': 'Instituto do Cancer-Hospital Mae de Deus, Porto Alegre, Brazil.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Ankara University, Ankara, Turkey.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ovilla', 'Affiliation': 'Hospital Angeles Lomas, Naucalpan de Juárez y alrededores, Mexico.'}, {'ForeName': 'Jae-Cheol', 'Initials': 'JC', 'LastName': 'Jo', 'Affiliation': 'Ulsan University Hospital, Ulsan, South Korea.'}, {'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Tineke', 'Initials': 'T', 'LastName': 'Casneuf', 'Affiliation': 'Janssen Research & Development, LLC, Beerse, Belgium.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'DeAngelis', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Himal', 'Initials': 'H', 'LastName': 'Amin', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Scientific Affairs, Horsham, PA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kobos', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'University Hospital of Salamanca/IBSAL/Cancer Research Center-IBMCC (USAL-CSIC), Salamanca, Spain.'}]",Journal of hematology & oncology,['10.1186/s13045-020-00948-5']
1669,32817407,"Bilateral ultrasound-guided thoracic erector spinae plane blocks using a programmed intermittent bolus improve opioid-sparing postoperative analgesia in pediatric patients after open cardiac surgery: a randomized, double-blind, placebo-controlled trial.","BACKGROUND


Postoperative pain after pediatric cardiac surgery is usually treated with intravenous opioids. Recently, the focus has been on postoperative regional analgesia with the introduction of ultrasound-guided erector spinae plane blocks (ESPBs). We hypothesized that bilateral ESPB with a programmed intermittent bolus (PIB) regimen decreases postoperative morphine consumption at 48 hours and improves analgesia in children who undergo cardiac surgery.
METHODS


This randomized, double-blind, placebo-controlled study comprised 50 children who underwent cardiac surgery through midline sternotomy. The patients were allocated randomly into two groups: ultrasound-guided bilateral ESPB at the level of T3-T4 transverse process then PIB with saline infusion (group 1, n=23) or PIB with 0.2% ropivacaine (group 2, n=27). Intravenous morphine at 30 µg/kg/hour was used as rescue analgesia. Postoperative pain was assessed using the COMFORT-B score for extubation, drain removal, and mobilization, and the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 0, 2, 4, 6, 8, 12, 16, 20, 24, 36, and 48 hours after surgery. Adverse events were noted.
RESULTS


The total dose of morphine in 48 hours was significantly decreased in patients receiving a bilateral ESPB with ropivacaine (120±320 µg/kg) compared with patients with saline infusion (512±560 µg/kg; p=0.03). Fourteen per cent of patients required rescue analgesia with morphine in group 2 compared with 41% in group 1 (p=0.05). The patients in group 2 demonstrated significantly reduced COMFORT-B scores at extubation, drain removal, and mobilization compared with those in group 1 and had reduced FLACC scale levels at 20 and 24 hours postoperatively (p=0.05 and p=0.001, respectively). No differences were reported for extubation and drain removal times or for length of hospital stay. In addition, vomiting episodes were decreased in group 2 (p=0.01).
CONCLUSIONS


In pediatric cardiac surgery, the results of this study confirm our hypothesis that bilateral ESPB analgesia with ropivacaine decreases the postoperative morphine consumption at 48 hours and demonstrates better postoperative analgesia compared with a control group.  Trial registration number  NCT03593642.",2020,The total dose of morphine in 48 hours was significantly decreased in patients receiving a bilateral ESPB with ropivacaine (120±320 µg/kg) compared with patients with saline infusion (512±560 µg/kg; p=0.03).,"['pediatric patients after open cardiac surgery', '50 children who underwent cardiac surgery through midline sternotomy', 'children who undergo cardiac surgery']","['opioid-sparing postoperative analgesia', 'Intravenous morphine', 'morphine', 'ropivacaine', 'PIB with 0.2% ropivacaine', 'ultrasound-guided bilateral ESPB at the level of T3-T4 transverse process then PIB with saline infusion', 'intravenous opioids', 'Bilateral ultrasound-guided thoracic erector spinae plane blocks', 'placebo']","['vomiting episodes', 'extubation and drain removal times or for length of hospital stay', 'Adverse events', 'rescue analgesia', 'reduced COMFORT-B scores at extubation, drain removal, and mobilization', 'COMFORT-B score for extubation, drain removal, and mobilization, and the FLACC (Face, Legs, Activity, Cry, Consolability) scale', 'postoperative morphine consumption', 'FLACC scale levels', 'postoperative analgesia', 'Postoperative pain']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",50.0,0.598763,The total dose of morphine in 48 hours was significantly decreased in patients receiving a bilateral ESPB with ropivacaine (120±320 µg/kg) compared with patients with saline infusion (512±560 µg/kg; p=0.03).,"[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Macaire', 'Affiliation': 'Anesthesia and Pain Department, Vinmec International Hospital, Hanoi, Viet Nam.'}, {'ForeName': 'Nga', 'Initials': 'N', 'LastName': 'Ho', 'Affiliation': 'Department of Cardiac Surgery, Vinmec Central Park International Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Vien', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'Department of Cardiac Surgery, Vinmec Central Park International Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Hieu', 'Initials': 'H', 'LastName': 'Phan Van', 'Affiliation': 'Department of Pharmacology, Forensic Medicine Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dinh Nguyen Thien', 'Affiliation': 'Department of Pharmacology, Forensic Medicine Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bringuier', 'Affiliation': 'Department of Biostatistics, Hopital Lapeyronie, Montpellier, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Capdevila', 'Affiliation': 'Anesthesiology and Critical Care Department and Neurosciences Institute, Inserm U1051, Hopital Lapeyronie, Montpellier, France x-capdevila@chu-montpellier.fr.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101496']
1670,32816874,"Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial.","OBJECTIVE


In patients with type 2 diabetes uncontrolled with metformin, exenatide once weekly (QW) plus dapagliflozin produced greater reductions in glycemic parameters (glycated hemoglobin [HbA 1c ], fasting plasma glucose [FPG], and 2-h postprandial glucose [2-h PPG]), weight, and systolic blood pressure (SBP) than exenatide QW or dapagliflozin alone after 28 weeks of treatment in DURATION-8. Following a 24-week extension period, improvements were sustained at 52 weeks. In this study, we investigated efficacy and safety at 104 weeks after randomization.
RESEARCH DESIGN AND METHODS


DURATION-8 was a 104-week, multicenter, double-blind, randomized, active-controlled, phase 3 trial. In total, 695 adults (aged ≥18 years) with type 2 diabetes and inadequate glycemic control (HbA 1c  8.0-12.0% [64-108 mmol/mol]) despite stable metformin monotherapy (≥1,500 mg/day) were randomly assigned (1:1:1) to receive exenatide 2 mg QW plus once-daily dapagliflozin 10 mg, exenatide QW plus placebo, or dapagliflozin plus placebo. All 104-week evaluations were exploratory.
RESULTS


At week 104, 431 (62.0%) patients completed treatment. The adjusted least squares mean change (SE) from baseline to week 104 in HbA 1c  was greater with exenatide QW plus dapagliflozin (-1.70% [0.11]) versus exenatide QW plus placebo (-1.29% [0.12];  P  = 0.007) and dapagliflozin plus placebo (-1.06% [0.12];  P  < 0.001). Clinically relevant changes in FPG, 2-h PPG, weight, and SBP were also observed with exenatide QW plus dapagliflozin. There were no unexpected safety findings, and exenatide QW plus dapagliflozin was well tolerated, with no episodes of major hypoglycemia.
CONCLUSIONS


In this exploratory analysis, among those individuals who completed the trial without rescue therapy, there was clinically relevant efficacy over 2 years with exenatide QW plus dapagliflozin, with no unexpected safety findings.",2020,"There were no unexpected safety findings, and exenatide QW plus dapagliflozin was well tolerated, with no episodes of major hypoglycemia.
","['Study', 'patients with type 2 diabetes uncontrolled with', '695 adults (aged ≥18 years) with type 2 diabetes and inadequate glycemic control (HbA 1c  8.0-12.0% [64-108 mmol/mol]) despite stable metformin monotherapy (≥1,500 mg/day']","['exenatide QW plus placebo', 'metformin, exenatide once weekly (QW) plus dapagliflozin', 'dapagliflozin plus placebo', 'exenatide QW or dapagliflozin', 'exenatide QW plus dapagliflozin', 'exenatide 2 mg QW plus once-daily dapagliflozin 10 mg, exenatide QW plus placebo, or dapagliflozin plus placebo', 'Exenatide Plus Dapagliflozin']","['Efficacy and Safety', 'FPG, 2-h PPG, weight, and SBP', 'glycemic parameters (glycated hemoglobin [HbA 1c ], fasting plasma glucose [FPG], and 2-h postprandial glucose [2-h PPG]), weight, and systolic blood pressure (SBP', 'efficacy and safety']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C4026820', 'cui_str': 'exenatide 2 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",695.0,0.224679,"There were no unexpected safety findings, and exenatide QW plus dapagliflozin was well tolerated, with no episodes of major hypoglycemia.
","[{'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Jabbour', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA serge.jabbour@jefferson.edu.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frías', 'Affiliation': 'National Research Institute, Los Angeles, CA.'}, {'ForeName': 'Azazuddin', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Apex Medical Research, Chicago, IL.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Statum Research, Irvine, CA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Guja', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}]",Diabetes care,['10.2337/dc19-1350']
1671,32777617,Longitudinal suicide ideation trajectories in a clinical trial of brief CBT for U.S. military personnel recently discharged from psychiatric hospitalization.,"Research among adolescent samples has suggested patterns of change in suicidal ideation (SI) following psychiatric hospitalization discharge are heterogenous and predictive of subsequent suicide attempts. However, no studies have examined SI trajectories following discharge among adult samples or the effect of treatment on trajectories. We used growth mixture modeling to examine trajectories of SI among 152 active duty military personnel in a randomized controlled trial comparing brief cognitive-behavioral therapy (CBT) for suicide prevention to treatment as usual following discharge from inpatient psychiatric hospitalization for a suicide risk. Analyses of SI at baseline, 3-, 6-, and 12-months post-discharge among the full sample randomized to both conditions revealed two trajectories: rapid improvers (59.21%) and gradual improvers (40.79%). Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge. Exploratory analyses suggested that, relative to those in the treatment as usual condition, those randomized to brief CBT in both trajectories may be less likely to make a suicide attempt during the follow-up period. Results replicate and extend prior research in identifying distinct ideation trajectories following psychiatric inpatient hospitalization for suicide risk to active-duty personnel in a treatment trial and linking these trajectories to suicide attempts during follow-up.",2020,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,['152 active duty military personnel'],['cognitive-behavioral therapy (CBT'],['Longitudinal suicide ideation trajectories'],"[{'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}]",152.0,0.135962,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'National Center for PTSD, Boston, MA, United States; VA Boston Healthcare System, Boston, MA, United States; Boston University School of Medicine, Boston, MA, United States. Electronic address: daniel.lee14@va.gov.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Memphis, Memphis, TN, United States.'}]",Psychiatry research,['10.1016/j.psychres.2020.113335']
1672,32777664,Digital application developed to evaluate functional results following robot-assisted radical prostatectomy: App for prostate cancer.,"INTRODUCTION


Mobile applications (""apps"") developed for smartphones and tablets are increasingly used in healthcare, allowing remote patient support or promoting self-health care. Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy. The main complications following surgery are urinary incontinence and erectile dysfunction. However, the exact numbers related to these morbidities are often missing due to brief interviews during consultations in the medical office. Therefore, the aim of this study was to create an app to determine whether response rates to pre- and post-surgical PC questionnaires will increase.
METHODS


The app was built using the IONIC framework system and provided to patients through a prospective randomized study. We included 100 patients divided into two groups: 1. first group used the app (n = 50); and 2. second group responded via validated printed questionnaires (control group) (n = 50). All patients received discharge counseling to respond to the questionnaires 1, 3, 6 and 12 months after the procedure. The app group received verbal guidance on how monitoring would occur, received an SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires.
RESULTS


The new app is called UroHealth and is available for download in the Apple App Store or at www.urohealth.com.br. When we evaluated the response rates, we found that 42.9% of the patients answered the preoperative questionnaire in the app group, while 16% responded in the control group (p = 0.003). By the end of the follow-up, we found that 24.5% of the patients answered the questionnaire in the app group, while 4% responded in the control group (p = 0.003).
CONCLUSION


This app enabled almost 6 times more patients to answer long-term follow-up questions after surgical procedures, providing high-quality information regarding morbidity related to treatment. Although our initial results indicate that this app may become a useful tool in obtaining more frequent and realistic answers, thus helping to improve surgical techniques, other ways of reaching the patient should be tested to achieve higher response rates.",2020,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.",['100 patients divided into two groups: 1. first group used the app (n\xa0=\xa050); and'],"['robot-assisted radical prostatectomy', 'SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires', 'verbal guidance', '2. second group responded via validated printed questionnaires (control group', 'discharge counseling']","['response rates', 'preoperative questionnaire', 'urinary incontinence and erectile dysfunction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}]",100.0,0.0209113,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.","[{'ForeName': 'Leandro F', 'Initials': 'LF', 'LastName': 'Faria', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: lfaria83@gmail.com.'}, {'ForeName': 'Sabrina T', 'Initials': 'ST', 'LastName': 'Reis', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Faculdade Atenas - Campus Passos, Minas Gerais, 37900-380, Brazil. Electronic address: sasareis@gmail.com.'}, {'ForeName': 'Katia R', 'Initials': 'KR', 'LastName': 'Leite', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: katiaramos@usp.br.'}, {'ForeName': 'José Arnaldo Shiomi', 'Initials': 'JAS', 'LastName': 'da Cruz', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: arnadolshiomi@yahoo.com.br.'}, {'ForeName': 'Ruan', 'Initials': 'R', 'LastName': 'Pimenta', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: ruanpimenta22@gmail.com.'}, {'ForeName': 'Nayara I', 'Initials': 'NI', 'LastName': 'Viana', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: nayara_viana_2@hotmail.com.'}, {'ForeName': 'Gabriela Q', 'Initials': 'GQ', 'LastName': 'Amaral', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: gabriela.queiroz.amaral@gmail.com.'}, {'ForeName': 'Gabriel A G D', 'Initials': 'GAGD', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: arantes_gabriel@hotmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ilias', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: daniel.ilias22@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fakhouri', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: ffakhouri@gmail.com.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Xavier', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: geraldoxaviermed@gmail.com.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: srougi@uol.com.br.'}, {'ForeName': 'Carlo Camargo', 'Initials': 'CC', 'LastName': 'Passerotti', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: carlopasserotti@hotmail.com.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105683']
1673,32777692,Health-related quality of life and opioid use disorder pharmacotherapy: A secondary analysis of a clinical trial.,"OBJECTIVE


To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients.
METHODS


We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes.
RESULTS


We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics.
CONCLUSION


Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.",2020,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","['persons with opioid use disorder seeking treatment', 'persons with opioid use disorder (OUD', 'participants who reported HRQoL beyond baseline']","['naltrexone or buprenorphine-naloxone', 'opioid use disorder pharmacotherapy']",['health-related quality-of-life (HRQoL'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",508.0,0.0789426,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA. Electronic address: alj4004@med.cornell.edu.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'Ryan', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Jeng', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'McCollister', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Leff', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Novo', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108221']
1674,32773602,"Double-blind, randomized, placebo-controlled crossover trial of alpha-lipoic acid for the treatment of fibromyalgia pain: the IMPALA trial.","Fibromyalgia is a common and challenging chronic pain disorder with few, if any, highly effective and well-tolerated treatments. Alpha-lipoic acid (ALA) is a nonsedating antioxidant with evidence of efficacy in the treatment of symptomatic diabetic neuropathy that has not been evaluated in the setting of fibromyalgia treatment. Thus, we conducted a single-centre, proof-of-concept, randomized, placebo-controlled, crossover trial of ALA for the treatment of fibromyalgia. Twenty-seven participants were recruited, and 24 participants completed both treatment periods of the trial. The median maximal tolerated dose of ALA in this trial was 1663 mg/day. Treatment-emergent adverse events with ALA were infrequent and not statistically different from placebo. For the primary outcome of pain intensity, and for several other validated secondary outcomes, there were no statistically significant differences between placebo and ALA. A post hoc exploratory subgroup analysis showed a significant interaction between gender and treatment with a significant favourable placebo-ALA difference in pain for men, but not for women. Overall, the results of this trial do not provide any evidence to suggest promise for ALA as an effective treatment for fibromyalgia, which is predominantly prevalent in women. This negative clinical trial represents an important step in a collective strategy to identify new, better tolerated and more effective treatments for fibromyalgia.",2020,"For the primary outcome of pain intensity, and for several other validated secondary outcomes, there were no statistically significant differences between placebo and ALA.","['fibromyalgia pain', 'Twenty-seven participants were recruited and 24 participants completed both treatment periods of the trial']","['Alpha-lipoic acid (ALA', 'ALA', 'alpha-lipoic acid', 'placebo']","['pain intensity', 'median maximal tolerated dose of ALA']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}]",27.0,0.743478,"For the primary outcome of pain intensity, and for several other validated secondary outcomes, there were no statistically significant differences between placebo and ALA.","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gilron', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Kingston Health Sciences Centre, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Robb', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Kingston Health Sciences Centre, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': ""Departments of Public Health Sciences and Mathematics and Statistics, and the Cancer Research Institute, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Holden', 'Affiliation': ""Department of Psychology, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Tanveer', 'Initials': 'T', 'LastName': 'Towheed', 'Affiliation': ""Department of Medicine, Division of Rheumatology, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ziegler', 'Affiliation': 'Institute for Clinical Diabetology, German Diabetes Center, Lebniz Center for Diabetes Research and Division of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Louie', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Kingston Health Sciences Centre, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Milev', 'Affiliation': ""Centre for Neuroscience Studies, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Gray Research Consulting, Pharmacy Research Services, EpiPharm Consultants, Joyceville, ON, Canada.'}]",Pain,['10.1097/j.pain.0000000000002028']
1675,32785689,Markers of Iron Flux during Testosterone-Mediated Erythropoiesis in Older Men with Unexplained or Iron-Deficiency Anemia.,"CONTEXT


Testosterone treatment of hypogonadal men improves their hemoglobin, but the mechanism is not understood.
OBJECTIVE


To investigate possible mechanisms by which testosterone stimulates erythropoiesis in hypogonadal older men with unexplained or iron-deficiency anemia.
DESIGN


The Anemia Trial of The Testosterone Trials, a placebo-controlled study in older, hypogonadal men.
SETTING


Twelve academic medical centers.
PARTICIPANTS


A total of 95 hypogonadal men (testosterone < 275 ng/mL) ≥65 years with anemia (hemoglobin < 12.7 g/dL). They were classified as having unexplained (n = 58) or iron deficiency anemia (n = 37).
INTERVENTION


Testosterone or placebo gel for 1 year.
MAIN OUTCOME MEASURES


Markers of iron metabolism during the first 3 months of treatment.
RESULTS


Testosterone replacement significantly (P < 0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% confidence interval, 0.31-0.85). Testosterone replacement tended to increase hemoglobin in the 37 men who had iron deficiency (0.38 g/dL; -0.19, 0.95), but the response was more variable and not statistically significant (P = 0.19). In men with unexplained anemia, testosterone replacement suppressed hepcidin (-8.2 ng/mL; -13.7, -2.7; P = 0.004) and ferritin (-19.6 µg/L; -32.8, -6.3; P = 0.004), but in men with iron deficiency, testosterone replacement did not. The decrease in hepcidin was moderately correlated with the increase in hemoglobin in the men with unexplained anemia (correlation coefficient -0.35, P = 0.01) but not in those with iron deficiency anemia (correlation coefficient -0.07, P = 0.73).
CONCLUSIONS


Testosterone replacement of older hypogonadal men with unexplained anemia stimulates erythropoiesis associated with increased iron mobilization. This effect appears to be attenuated by iron deficiency.",2020,"RESULTS


Testosterone replacement significantly (p<0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% CI 0.31-0.85).","['older, hypogonadal men', 'older hypogonadal men with unexplained anemia stimulates erythropoiesis', 'They were classified as having unexplained (58) or iron deficiency anemia (37', 'hypogonadal older men with unexplained or iron-deficiency anemia', 'Older Men with Unexplained or Iron-Deficiency Anemia', 'hypogonadal men', 'Twelve academic medical centers', '95 hypogonadal men (testosterone <275 ng/mL) ≥65 years with anemia (hemoglobin <12.7 g/dL']","['Testosterone-Mediated Erythropoiesis', 'testosterone', 'Testosterone replacement', 'Testosterone or placebo gel', 'placebo']","['hemoglobin', 'Markers of iron metabolism', 'unexplained anemia', 'hepcidin']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}]",95.0,0.520846,"RESULTS


Testosterone replacement significantly (p<0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% CI 0.31-0.85).","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Artz', 'Affiliation': 'City of Hope, Department of Hematology and Hematopoietic Cell Transplantation, Duarte, California.'}, {'ForeName': 'Alisa J', 'Initials': 'AJ', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Duke University Medical Center, Center for the Study of Aging, Durham, North Carolina.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa521']
1676,32791321,Guilt and expressive writing for reducing alcohol use in college students: Study protocol for a randomized control trial.,"The current proposed study aims to evaluate expressive writing as a novel intervention for reducing problematic drinking among college students. College students are at increased risk for alcohol misuse compared to other adults, and the development of efficacious intervention approaches is an urgent priority. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to refinements of this paradigm, which require large-scale assessment and intricate programming for implementation. The present research proposes expressive writing as a novel alternative, which has been used extensively in other domains but not as an alcohol intervention strategy. We propose a theoretically-based approach that incorporates expression of the self-conscious emotion of guilt and the written analogue of change talk as proposed mechanisms of intervention efficacy. We will also examine individual differences in guilt-proneness as a moderator of intervention efficacy. Heavy drinking college students (N = 600) will be randomly assigned to one of six expressive writing conditions based on a 2 (alcohol vs. distress) × 2 (guilt vs. no guilt) + 1 (control writing) + 1 (personalized feedback) design. Participation in the study involves completion of a screening assessment, a baseline assessment, three in-lab intervention sessions, post-intervention assessments, and follow-up assessments one-month, three-months, six months, and twelve-months later. If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.",2020,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","['College students', 'Heavy drinking college students (N\u202f=\u202f600', 'college students']","['\u202f1 (control writing', 'Guilt and expressive writing', 'six expressive writing conditions based on a 2 (alcohol vs. distress']",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",[],600.0,0.018722,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","[{'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Jordanna Lembo', 'Initials': 'JL', 'LastName': 'Riggs', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Chelsie M', 'Initials': 'CM', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Rowan University, Glassboro, NJ, United States of America.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Angosta', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America. Electronic address: jangosta@central.uh.edu.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Cunningham-Erdogdu', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America; Department of Psychology, University of Texas at Austin, Austin, TX, United States of America.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Health Disparities Research, University of Texas, MD Anderson Cancer Center, Houston, TX, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106107']
1677,32791499,Use of a Supportive Kidney Care Video Decision Aid in Older Patients: A Randomized Controlled Trial.,"BACKGROUND


There are few studies of patient-facing decision aids that include supportive kidney care as an option. We tested the efficacy of a video decision aid on knowledge of supportive kidney care among older patients with advanced CKD.
METHODS


Participants (age ≥ 65 years with advanced CKD) were randomized to receive verbal or video education. Primary outcome was knowledge of supportive kidney care (score range 0-3). Secondary outcomes included preference for supportive kidney care, and satisfaction and acceptability of the video.
RESULTS


Among all participants (n = 100), knowledge of supportive kidney care increased significantly after receiving education (p < 0.01); however, there was no difference between study arms (p = 0.68). There was no difference in preference for supportive kidney care between study arms (p = 0.49). In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care. Most felt comfortable watching the video (96%), felt the content was helpful (96%), and would recommend the video to others (96%).
CONCLUSIONS


Among older patients with advanced CKD, we did not detect a significant difference between an educational verbal script and a video decision aid in improving knowledge of supportive kidney care or preferences. However, patients who received video education reported high satisfaction and acceptability ratings. Future research will determine the effectiveness of a supportive kidney care video decision aid on real-world patient outcomes.
TRIAL REGISTRATION


NCT02698722 (ClinicalTrials.gov).",2020,"In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care.","['Participants (age ≥ 65 years with advanced CKD', 'Older Patients', 'older patients with advanced CKD']","['verbal or video education', 'video decision aid', 'Supportive Kidney Care Video Decision Aid']","['knowledge of supportive kidney care', 'satisfaction and acceptability ratings', 'total health literacy score', 'preference for supportive kidney care', 'educational verbal script', 'knowledge of supportive kidney care (score range 0-3', 'preference for supportive kidney care, and satisfaction and acceptability of the video']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",100.0,0.12439,"In adjusted analyses, total health literacy score (aOR 1.08 [95% CI: 1.003-1.165]) and nephrologists' answer of ""No"" to the Surprise Question (aOR 4.87 [95% CI: 1.22-19.43]) were associated with preference for supportive kidney care.","[{'ForeName': 'Nwamaka D', 'Initials': 'ND', 'LastName': 'Eneanya', 'Affiliation': 'Renal-Electrolyte Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA, nwamaka.eneanya@pennmedicine.upenn.edu.'}, {'ForeName': 'Shananssa G', 'Initials': 'SG', 'LastName': 'Percy', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Stallings', 'Affiliation': 'Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David J R', 'Initials': 'DJR', 'LastName': 'Steele', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Germain', 'Affiliation': 'Division of Nephrology, Baystate Medical Center, University of Massachusetts Medical School - Baystate, Springfield, Massachusetts, USA.'}, {'ForeName': 'Jane O', 'Initials': 'JO', 'LastName': 'Schell', 'Affiliation': 'Division of Renal-Electrolyte, Department of General Medicine, Section of Palliative Care and Medical Ethics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Paasche-Orlow', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'Division of General Medicine, Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}]",American journal of nephrology,['10.1159/000509711']
1678,32798568,Effect of exercise and grape juice on epigenetic modulation and functional outcomes in PD: A randomized clinical trial.,"OBJECTIVE


This study aimed to investigate the impact of an aquatic physical training program associated with grape juice (Vitis labrusca) consumption on functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels in peripheral blood from individuals with Parkinson's disease.
METHODS


Nineteen participants were randomized to Aquatic Exercise (AQ, n = 9) and Aquatic Exercise + Grape Juice (AQ+GJ, n = 10) groups and performed to 4 weeks of an aquatic intervention (twice a week, approximately 60 min/session). The AQ+GJ groups also consumed 400 mL of grape juice per day during this period. Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS) were evaluated before and after intervention. In addition, blood collections were carried out for biomarker analysis (e.g. BDNF and global histone H4).
RESULTS


The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity. In addition, enhanced levels of BDNF and histone H4 acetylation were found after the intervention. Grape juice consumption did not potentiate these effects, since any significant differences between the AQ and AQ+GJ groups were not found in all analysed variables.
CONCLUSIONS


The present study provides important insights about aquatic exercise-modulated BDNF levels in individuals with Parkinson's disease in combination with functional improvements, suggesting that histone acetylation status may interact to dictate the molecular mechanisms involved in this response. Parkinson disease, aquatic exercise, BDNF, epigenetic, grape juice.",2020,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","['PD', ""individuals with Parkinson's disease"", ""peripheral blood from individuals with Parkinson's disease"", 'Nineteen participants']","['exercise and grape juice', 'AQ+GJ', 'aquatic exercise program', 'aquatic exercise-modulated BDNF levels', 'Aquatic Exercise (AQ, n=9) and Aquatic Exercise\u202f+\u202fGrape Juice (AQ+GJ, n=10) groups and performed to 4 weeks of an aquatic intervention', 'aquatic physical training program associated with grape juice (Vitis labrusca) consumption']","['functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels', 'enhanced levels of BDNF and histone H4 acetylation', 'Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS', 'epigenetic modulation and functional outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",19.0,0.0396303,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","[{'ForeName': 'Grazielle Silva De', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Iraci', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Gislaine Siqueira', 'Initials': 'GS', 'LastName': 'Pinheiro', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Marcela Zimmermann', 'Initials': 'MZ', 'LastName': 'Casal', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil.'}, {'ForeName': 'Flavia Gomes', 'Initials': 'FG', 'LastName': 'Martinez', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Elsner', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil; Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil; Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil. Electronic address: carolinedani@yahoo.com.br.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113135']
1679,32798570,Perceptual responses: Clinical versus practical blood flow restriction resistance exercise.,"The purpose of the current investigation was to compare the acute perceptual responses during low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE), to determine if these responses differed between young males and females. Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design: 1) cBFR-RE, 2) pBFR-RE, 3) HL-RE, and 4) LL-RE. Low-load conditions consisted of 30-15-15-15 repetitions of two-leg press (LP) and knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE consisted of 3 sets of 10 repetitions at 80% 1-RM, all with 60s rest intervals. Ratings of perceived exertion (RPE) and discomfort were assessed before exercise and immediately following each set. RPE was significantly higher in HL-RE compared to all low-load conditions for both exercises after each set (all p<0.05). cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05). Levels of discomfort were similar between cBFR-RE and HL-RE, which tended to be significantly higher than pBFR-RE and LL-RE (p<0.05). Men reported significantly greater RPE than women following sets 2-4 during KE with cBFR-RE and sets 2 and 3 during KE for HL-RE (all p<0.05). Males also reported significantly greater discomfort than women following sets 2-4 for KE LL-RE (p<0.05). Altogether, these data suggest that pBFR-RE may provide a more favorable BFR condition based on perceptual responses and that perceptual responses may differ between sexes across varying resistance exercise conditions.",2020,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"['Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design', 'young males and females']","['low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE', 'knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE']","['Levels of discomfort', 'Ratings of perceived exertion (RPE) and discomfort', 'acute perceptual responses', 'discomfort', 'RPE']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.0352726,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA. Electronic address: ryanmiller1@ou.edu.'}, {'ForeName': 'Bianca A R', 'Initials': 'BAR', 'LastName': 'Galletti', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Karolina J', 'Initials': 'KJ', 'LastName': 'Koziol', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA; Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Black', 'Affiliation': 'Department of Health and Exercise Science, Sensory and Muscle Function Research Laboratory, University of Oklahoma, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Larson', 'Affiliation': 'Departmeny of Health and Exercise Science, Sport, Health, and Exercise Data Analytics Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Bemben', 'Affiliation': 'Departmeny of Health and Exercise Science, Bone Density Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113137']
1680,32798588,Anti-erosive effect of rinsing before or after toothbrushing with a Fluoride/Stannous Ions solution: an in situ investigation: Application order of Fluoride/Tin products for erosive tooth wear.,"OBJECTIVE


To evaluate the impact of the application of a F - /Sn 2+ -containing mouthrinse before or after toothbrushing with a F - /Sn 2+ /chitosan toothpaste on the progression of erosion/abrasion on enamel and dentin.
METHODS


This crossover in situ study had five arms: Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing + Rinsing, Rinsing + Brushing, and Rinsing (without toothbrushing). Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to erosion-abrasion cycling of 60 min salivary pellicle formation followed by 5 min extra-oral erosion with 1% citric acid (4x/day for 5 days). Treatments were performed in situ after first and last erosive challenges with rinse (10 ml; 30 s) and/or toothbrushing with/without toothpaste (with electric toothbrush; 5 s per specimen; total 2 min contact with slurry). Surface loss (SL) was evaluated with an optical profilometer. Data were analyzed by two-way repeated measures ANOVA and Tukey tests (α = 0.05).
RESULTS


The Control showed the highest SL (mean ± SD for enamel: 24.58 ± 11.32; dentin: 32.32 ± 10.10; all μm). Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing. None of the arms that underwent toothbrushing with the toothpaste differed from each other (p > 0.05). Dentin specimens showed significantly higher SL values than enamel (p < 0.001).
CONCLUSION


The order of treatment applications had no influence on their anti-erosive effect; however, toothbrushing with F - /Sn 2+ /chitosan toothpaste reduced enamel surface loss. Additional rinsing with F - /Sn 2+  mouthrinse did not offer improved protection.
CLINICAL SIGNIFICANCE


The use of fluoride- and stannous- containing toothpastes and mouthrinses is an important approach in the prevention of erosive tooth wear. Further evidence is needed to support the benefit of combining these products against this condition.",2020,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","['Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to']","['Rinsing', 'erosion-abrasion cycling of 60\u2009min salivary pellicle formation followed by 5\u2009min extra-oral erosion with 1% citric acid', 'fluoride- and stannous- containing toothpastes and mouthrinses', 'Fluoride/stannous Ions Solution', 'F-/Sn2+/chitosan toothpaste', 'F-/Sn2+ mouthrinse', 'Fluoride/Tin products', 'Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing\u2009+\u2009Rinsing, Rinsing\u2009+\u2009Brushing, and Rinsing (without toothbrushing', 'toothbrushing with/without toothpaste (with electric toothbrush; 5\u2009s per specimen; total 2\u2009min contact with slurry', 'F-/Sn2+-containing mouthrinse']","['Surface loss (SL', 'progression of erosion/abrasion on enamel and dentin', 'protection', 'enamel surface loss', 'SL values', 'SL value']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1292488', 'cui_str': 'Dentin specimen'}]","[{'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0225144,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Machado', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: alanam@usp.br.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Sakae', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: leticia.sakae@usp.br.'}, {'ForeName': 'Samira Helena', 'Initials': 'SH', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: samira.joaosouza@gmail.com.'}, {'ForeName': 'Thiago Saads', 'Initials': 'TS', 'LastName': 'Carvalho', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: thiago.saads@zmk.univbe.ch.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, University of Texas Health Science Center of San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States. Electronic address: amaechi@uthscsa.edu.'}, {'ForeName': 'Taís', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: tais.sca@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103450']
1681,32800022,Community-based self-management of chronic low back pain in a rural African primary care setting: a feasibility study.,"A small pragmatic non-randomised controlled study investigated the feasibility and acceptability of a novel theory-informed community-based self-management programme targeting the biopsychosocial factors associated with chronic low back pain disability in a rural Nigerian primary care centre. Participants either received the programme, once weekly for 6 weeks, or usual care. The programme combined group exercise sessions with group/individual discussion sessions, informed by cognitive behavioural therapy and motivational interviewing. Recruitment rate, intervention delivery, proportion of planned treatment attended, retention/dropout rate, adherence to recommended self-management strategies and biopsychosocial outcomes were used to determine feasibility. Structured qualitative exit feedback interviews ascertained acceptability. Recruitment rate was 100%, treatment uptake was 83% and loss to follow-up was 8%. Greater benefits for the self-management group compared with control were observed for primary and secondary biopsychosocial outcomes. Although the programme appears promising, the exploratory design of this study warrants more rigorous intervention testing following suggested programme improvement.",2019,Greater benefits for the self-management group compared with control were observed for primary and secondary biopsychosocial outcomes.,['rural Nigerian primary care centre'],"['novel theory-informed community-based self-management programme', 'Community-based self-management', 'programme combined group exercise sessions with group/individual discussion sessions, informed by cognitive behavioural therapy and motivational interviewing']","['Recruitment rate, intervention delivery, proportion of planned treatment attended, retention/dropout rate, adherence to recommended self-management strategies and biopsychosocial outcomes', 'Recruitment rate', 'chronic low back pain disability']","[{'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.0823773,Greater benefits for the self-management group compared with control were observed for primary and secondary biopsychosocial outcomes.,"[{'ForeName': 'Chinonso N', 'Initials': 'CN', 'LastName': 'Igwesi-Chidobe', 'Affiliation': 'Department of Medical Rehabilitation, Faculty of Health Sciences and Technology, College of Medicine, University of Nigeria (Enugu Campus), Enugu, Nigeria.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Godfrey', 'Affiliation': ""Department of Physiotherapy, School of Population Health Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Kitchen', 'Affiliation': ""Department of Physiotherapy, School of Population Health Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Chika N', 'Initials': 'CN', 'LastName': 'Onwasigwe', 'Affiliation': 'Department of Community Medicine, Faculty of Medical Sciences, College of Medicine, University of Nigeria (Enugu Campus), Enugu, Nigeria.'}, {'ForeName': 'Isaac O', 'Initials': 'IO', 'LastName': 'Sorinola', 'Affiliation': ""Department of Physiotherapy, School of Population Health Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",Primary health care research & development,['10.1017/S1463423619000070']
1682,32805520,Blunted salivary cortisol response to psychosocial stress in women with posttraumatic stress disorder.,"Posttraumatic stress disorder (PTSD) is characterized by alterations in the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system (SNS). There is evidence for a blunted HPA axis reactivity to psychosocial stress. Less is known about how the SNS reacts to psychosocial stress. Here, we compared the HPA axis and SNS responses to psychosocial stress and a non-stressful condition in patients with PTSD and in healthy individuals. Twenty-one women with PTSD and 32 healthy women participated in the Trier social stress test (TSST) and placebo TSST (P-TSST). We measured salivary cortisol, alpha amylase activity and blood pressure before and after the tests. Subjective perceived stress response was also assessed. We found a blunted cortisol response to the TSST in patients with PTSD compared with healthy participants 10 min (t (51) = -2.58, p = .01) and 25 min (t (51) = -2.16, p = .04) after TSST. We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05). Patients with PTSD, but not healthy participants, reported more dissociative symptoms (t (20) = -2.31, p = .03) and being more tired (t (20) = 2.90, p = .01) directly after TSST compared with the placebo condition. Our results suggest a blunted HPA stress reactivity and an increased subjective perceived stress response in female patients with PTSD. Longitudinal studies could test if these altered stress responses constitute a predisposition to or a cause of PTSD. Future studies should investigate whether these results are transferable to men.",2020,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"['Posttraumatic stress disorder (PTSD', 'patients with PTSD and in healthy individuals', 'women with posttraumatic stress disorder', 'patients with PTSD compared with healthy participants 10\xa0min (t (51)\xa0', 'female patients with PTSD', 'Twenty-one women with PTSD and 32 healthy women participated in the']","['TSST', 'Trier social stress test (TSST) and placebo TSST (P-TSST']","['blunted cortisol response', 'blunted HPA stress reactivity', 'Subjective perceived stress response', 'SNS reactivity', 'dissociative symptoms', 'salivary cortisol, alpha amylase activity and blood pressure', 'Blunted salivary cortisol response']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",21.0,0.0110716,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: sophie.metz@charite.de.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Hellmann-Regen', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Faculty of Psychology, Ruhr University, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.014']
1683,32811342,Treatment of Subclinical Hyperthyroidism in the Elderly: Comparison of Radioiodine and Long-Term Methimazole Treatment.,"Background:  This study aimed to compare the effectiveness and safety of radioiodine (RAI) and long-term methimazole (MMI) in the treatment of subclinical hyperthyroidism (SH) in the elderly.  Methods:  From 306 patients, aged ≥65 years, with SH, 83 patients with thyrotropin <0.1 mU/L entered the study. In this randomized parallel-group trial, 41 and 42 patients were randomized to either RAI or long-term MMI treatment, respectively.  Results:  In the RAI and MMI groups, 3 and 4 patients were excluded due to side effects, choosing other modes of treatment, and not returning for follow-up; 35 and 36 patients completed 60 months of follow-up, respectively. In the RAI group, 23 (66%) became hypothyroid, and 12 (34%) remained euthyroid 60 months after a fixed dose of 15 mCi RAI. In the MMI group, the starting dose was 10 mg daily and decreased to 4.9 ± 1.0, 4.3 ± 1.0, 4.4 ± 1.4, 4.3 ± 1.8, and 3.7 ± 1.3 mg after 1, 2, 3, 4, and 5 years of continuous MMI treatment, employing titration method. By the end of study, 34 (94%) patients were euthyroid and 2 patients with diffuse goiter developed spontaneous hypothyroidism with MMI treatment. Minor adverse events occurred in both groups in the first four months of treatment. No death or serious side effects were observed during 60 months of follow-up.  Conclusions:  Both RAI and long-term low-dose MMI therapies are effective and safe for treatment of SH in the elderly.",2020,"No death or serious side effects were observed during 60 months of follow-up.
","['From 306 patients, aged ≥ 65 years, with subclinical hyperthyroidism', 'subclinical hyperthyroidism in the elderly', '41 and 42 patients', '83 patients with TSH<0.1 mU/L entered the study']","['RAI or long-term MMI', 'radioiodine (RAI) and long-term methimazole (MMI', 'radioiodine']","['spontaneous hypothyroidism', 'No death or serious side effects', 'Minor adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1998045', 'cui_str': 'Subclinical hyperthyroidism'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439342', 'cui_str': 'mU/L'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2828294', 'cui_str': 'iodide ion I-131'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0025644', 'cui_str': 'Methimazole'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",83.0,0.0386865,"No death or serious side effects were observed during 60 months of follow-up.
","[{'ForeName': 'Fereidoun', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': 'Endocrine Research Center; Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hengameh', 'Initials': 'H', 'LastName': 'Abdi', 'Affiliation': 'Endocrine Research Center; Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Cheraghi', 'Affiliation': 'Department of Epidemiology and Biostatistics; Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atieh', 'Initials': 'A', 'LastName': 'Amouzegar', 'Affiliation': 'Endocrine Research Center; Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2020.0433']
1684,32827042,Response of Mitochondrial Respiration in Adipose Tissue and Muscle to 8 Weeks of Endurance Exercise in Obese Subjects.,"CONTEXT


Exercise training improves glycemic control and increases mitochondrial content and respiration capacity in skeletal muscle. Rodent studies suggest that training increases mitochondrial respiration in adipose tissue.
OBJECTIVE


To assess the effects of endurance training on respiratory capacities of human skeletal muscle and abdominal subcutaneous adipose tissue and to study the correlation with improvement in insulin sensitivity.
DESIGN


Using high-resolution respirometry, we analyzed biopsies from 25 sedentary (VO2 peak 25.1 ± 4.0 VO2 mL/[kg*min]) subjects (16 female, 9 male; 29.8 ± 8.4 years) with obesity (body mass index [BMI] 31.5 ± 4.3 kg/m2), who did not have diabetes. They performed a supervised endurance training over 8 weeks (3 × 1 hour/week at 80% VO2 peak).
RESULTS


Based on change in insulin sensitivity after intervention (using the Matsuda insulin sensitivity index [ISIMats]), subjects were grouped in subgroups as responders (>15% increase in ISIMats) and low-responders. The response in ISIMats was correlated to a reduction of subcutaneous and visceral adipose tissue volume. Both groups exhibited similar increases in fitness, respiratory capacity, and abundance of mitochondrial enzymes in skeletal muscle fibers. Respiratory capacities in subcutaneous adipose tissue were not altered by the intervention. Compared with muscle fibers, adipose tissue respiration showed a preference for β-oxidation and complex II substrates. Respiratory capacities were higher in adipose tissue from female participants.
CONCLUSION


Our data show that the improvement of peripheral insulin sensitivity after endurance training is not directly related to an increase in mitochondrial respiratory capacities in skeletal muscle and occurs without an increase in the respiratory capacity of subcutaneous adipose tissue.",2020,Our data show that the improvement of peripheral insulin sensitivity after endurance training is not directly related to an increase in mitochondrial respiratory capacities in skeletal muscle and occurs without an increase in the respiratory capacity of subcutaneous adipose tissue.,"['obese subjects', '25 sedentary (VO2 peak 25.1 ± 4.0 VO2 ml/(kg*min)) subjects (16 females, 9 males; 29.8 ± 8.4 yrs) with obesity (BMI 31.5 ± 4.3\xa0kg/m 2 ), who did not have diabetes']","['endurance exercise', 'endurance training', 'Exercise training', 'supervised endurance training']","['peripheral insulin sensitivity', 'Respiratory capacities', 'mitochondrial respiration', 'insulin sensitivity', 'fitness, respiratory capacity, and in abundance of mitochondrial enzymes in skeletal muscle fibers', 'subcutaneous and visceral adipose tissue volume']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C1704336', 'cui_str': 'Skeletal muscle fiber'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0367935,Our data show that the improvement of peripheral insulin sensitivity after endurance training is not directly related to an increase in mitochondrial respiratory capacities in skeletal muscle and occurs without an increase in the respiratory capacity of subcutaneous adipose tissue.,"[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': 'Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schneeweiss', 'Affiliation': 'Department of Sports Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Elko', 'Initials': 'E', 'LastName': 'Randrianarisoa', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Schnauder', 'Affiliation': 'Department of Internal Medicine IV, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kappler', 'Affiliation': 'Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Machann', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Schick', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fritsche', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heni', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Birkenfeld', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Niess', 'Affiliation': 'Department of Sports Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Häring', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Weigert', 'Affiliation': 'Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Moller', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa571']
1685,32822683,Randomized study of antiseptic application technique in healthy volunteers before vascular access insertion (TApAS trial).,"BACKGROUND


In France about 32% of hospitalized patients have a vascular access placement. However, a common complication associated with these is catheter-related bloodstream infection (CRBI) due to the introduction of microorganisms from the skin during catheter insertion. There is no consensus on the best way to clean the skin prior to catheter insertion, which could be a key element of CRBI prevention. The two techniques most commonly used to apply antiseptic to the skin are the concentric circle and back-and-forth techniques, but these have not been compared in clinical trials. Hence, this study conducted this comparison.
METHODS


This single-center, non-comparative, randomized, matched pilot study investigated the levels of cutaneous microorganisms before and after antiseptic application using both techniques in a population of healthy French volunteers. The two application methods were used on each participant's arms at the elbow fold, with randomization for the application side (right or left). Quantification of cutaneous microorganisms was performed in a blinded manner with regard to the technique used.
FINDINGS


From April 8 to July 17, 2019, 132 healthy volunteers participated in the study. For the whole study population, the mean initial colonization level was 2.68 log10 colony forming units (CFU)/mL (SD 0.82) before the back-and-forth technique, and 2.66 log10 CFU/mL (SD 0.85) before the concentric circle technique. The mean differences in number of microorganisms between the initial sample and the final sample were 2.45 log10 CFU/mL (95% CI: 2.29 to 2.61) for the back-and-forth technique and 2.43 log10 CFU/mL (95% CI: 2.27 to 2.59) for the concentric circle technique. The mean difference in reduction in microorganisms between the back-and-forth technique and the concentric circle technique was 0.02 log10 CFU/mL (95% CI: -0.11 to 0.15).
INTERPRETATION


There was no clinically difference in reduction of microorganisms between the concentric circle and back-and-forth techniques at the bend of the healthy volunteer's elbow, after the 30 s of drying of the antiseptic. These findings have a significant impact on time required to achieve antiseptic application before catheter insertion because there is yet no argument to justify application for 30 s, because a single concentric circle pass was much faster with similar results. Future studies should investigate the impact of skin application technique on the prevention of infectious risk associated with catheter insertion on admission to health care facilities (conventional, outpatient, or emergency) and throughout the period of stay in a health care facility.",2020,"There was no clinically difference in reduction of microorganisms between the concentric circle and back-and-forth techniques at the bend of the healthy volunteer's elbow, after the 30 seconds of drying of the antiseptic.","['healthy French volunteers', 'healthy volunteers before vascular access insertion (TApAS trial', 'Findings From April 8 to July 17, 2019, 132 healthy volunteers participated in the study']","['antiseptic application technique', 'log10 CFU/mL', 'CFU/mL']",['mean initial colonization level'],"[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1690986', 'cui_str': 'log10'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",132.0,0.0404688,"There was no clinically difference in reduction of microorganisms between the concentric circle and back-and-forth techniques at the bend of the healthy volunteer's elbow, after the 30 seconds of drying of the antiseptic.","[{'ForeName': 'Yolène', 'Initials': 'Y', 'LastName': 'Carre', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux F-33000, France. Electronic address: yolene.carre@chu-bordeaux.fr.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Moal', 'Affiliation': ""CHU Bordeaux, Service d'information médicale, F-33000 Bordeaux, France.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Germain', 'Affiliation': ""CHU Bordeaux, Service d'information médicale, F-33000 Bordeaux, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Frison', 'Affiliation': ""CHU Bordeaux, Service d'information médicale, F-33000 Bordeaux, France.""}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Dubreuil', 'Affiliation': 'Université de Bordeaux, Bordeaux Population Health Research Center, Pharmacoépidémiologie, UMR 1219, F-33000 Bordeaux, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Chansel', 'Affiliation': 'CHU de Bordeaux, Nursing Training Institute, F-33000 Bordeaux, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Berger', 'Affiliation': 'CHU Bordeaux Care and human sciences research unit, F-33000 Bordeaux France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Boulestreau', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux F-33000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Lasheras-Bauduin', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux F-33000, France.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Rogues', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux F-33000, France; Université de Bordeaux, Bordeaux Population Health Research Center, Pharmacoépidémiologie, UMR 1219, F-33000 Bordeaux, France.'}]",The Journal of infection,['10.1016/j.jinf.2020.08.022']
1686,32822775,Tocilizumab improves oxidative stress and endothelial glycocalyx: A mechanism that may explain the effects of biological treatment on COVID-19.,"We investigated the effects of tocilizumab on endothelial glycocalyx, a determinant of vascular permeability, and myocardial function in rheumatoid arthritis (RA). Eighty RA patients were randomized to tocilizumab (n = 40) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and glucocorticoids (GC) (n = 40) for 3 months. Forty healthy subjects with similar age and sex served as controls. We measured: (a)perfused boundary region (PBR) of the sublingual arterial microvessels (increased PBR indicates reduced glycocalyx thickness), (b)pulse wave velocity (PWV), (c)global LV longitudinal strain (GLS), (d)global work index (GWI) using speckle tracking echocardiography and e)C-reactive protein (CRP), malondialdehyde (MDA) and protein carbonyls (PCs) as oxidative stress markers at baseline and post-treatment. Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers (P < 0.05). Compared with baseline, tocilizumab reduced PBR(2.14 ± 0.2 versus 1.97 ± 0.2 μm; P < 0.05) while no significant differences were observed post-csDMARDs + GC(P > 0.05). Compared with csDMARDs + GC, tocilizumab achieved a greater increase of GLS, GWI and reduction of MDA, PCs and CRP(P < 0.05). The percent improvement of glycocalyx thickness (PBR) was associated with the percent decrease of PWV, MDA, PCs and the percent improvement of GLS and GWI(P < 0.05). Tocilizumab improves endothelial function leading to a greater increase of effective myocardial work than csDMARDs + GC through a profound reduction of inflammatory burden and oxidative stress. This mechanism may explain the effects of tocilizumab on COVID-19. CLINICAL TRIAL REGISTRATION: url: https://www.clinicaltrials.gov. Unique identifier: NCT03288584.",2020,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","['Eighty RA patients', 'Forty healthy subjects with similar age and sex served as controls', 'rheumatoid arthritis(RA']","['csDMARDs+GC', 'tocilizumab', 'csDMARDs+GC, tocilizumab', 'Tocilizumab', 'tocilizumab(n=40) or conventional synthetic disease-modifying antirheumatic drugs(csDMARDs) and glucocorticoids(GC']","['glycocalyx thickness), b)pulse wave velocity(PWV), c)global LV longitudinal strain(GLS), d)global work index(GWI) using speckle tracking echocardiography and e)C-reactive protein(CRP), malondialdehyde(MDA) and protein carbonyls(PCs) as oxidative stress markers', 'PWV, MDA, PCs and the percent improvement of GLS and GWI(P<0.05', 'oxidative stress and endothelial glycocalyx', 'glycocalyx thickness(PBR', 'GLS, GWI and reduction of MDA, PCs and CRP(P<0.05']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",80.0,0.0830911,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece. Electronic address: ignoik@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Pelagia', 'Initials': 'P', 'LastName': 'Katsimbri', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': '2nd Department of Internal Medicine, Research Unit and Diabetes Center, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Boumpas', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kouretas', 'Affiliation': 'Department of Biochemistry and Biotechnology, University of Thessaly, 41500, Larissa, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111694']
1687,32827553,Effect of Adding Neural Mobilization Versus Myofascial Release to Stabilization Exercises after Lumbar Spine Fusion: A Randomized Controlled Trial.,"OBJECTIVES


To test the effect of adding neural mobilization (NM) versus myofascial release (MFR) to stabilization exercises (SE) on disability, pain, and lumbar range of motion (ROM) in patients with lumbar spine fusion (LSF).
DESIGN


A single blinded, parallel groups, randomized controlled trial.
SETTING


Outpatient public and governmental hospital clinics.
PARTICIPANTS


Patients (N=60) who had undergone LSF were randomly assigned into 3 equal groups.
INTERVENTION


Group I received NM plus SE, group II received MFR and SE, and group III received SE only. Each group visited the hospital 3 times a week for 4 weeks.
MAIN OUTCOME MEASURES


Oswestry disability index (ODI), visual analog scale, and back range of motion (BROM) were assessed before starting treatment, immediately after finishing treatment, and 1 month later.
RESULTS


There were statistically significant differences among the groups regarding the ODI and pain (P<.05) in favor of the study groups, but no statistically significant differences were found among groups regarding the BROM outcome (P>.05). Regarding the within-group effect, statistically significant differences were found in all outcomes after 1 month of treatment, as well as after 1 month of follow-up in each group (P<.05).
CONCLUSIONS


Patients who received NM or MFR combined with SE demonstrated better improvement, in favor of the NM group, regarding disability and pain than patients who received SE alone after LSF. No differences were found among the groups regarding lumbar ROM.",2020,"There were Statistically significant differences among the groups regarding the ODI and pain (P<0.05) in favor of the study groups, but no statistically significant differences were found among groups regarding the BROM outcome (P>0.05).","['after Lumbar Spine Fusion', 'Sixty patients who have undergone lumbar spine fusion', 'patients with lumbar spine fusion (LSF', 'Outpatient public and governmental hospitals Clinics']","['neural mobilization (NM) versus myofascial release (MFR) to stabilization exercises (SE', 'Adding Neural Mobilization versus Myofascial Release to Stabilization Exercises', 'neural mobilization plus stabilization exercises, group (II) received myofascial release and stabilization exercises, and group (III) received stabilization exercises only']","['disability and pain', 'Oswestry disability index (ODI), visual analogue scale (VAS), and back range of motion device (BROM', 'lumbar ROM', 'BROM outcome', 'ODI and pain', 'disability, pain, and lumbar range of motion (ROM']","[{'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.0668133,"There were Statistically significant differences among the groups regarding the ODI and pain (P<0.05) in favor of the study groups, but no statistically significant differences were found among groups regarding the BROM outcome (P>0.05).","[{'ForeName': 'Mohsen Mohamed', 'Initials': 'MM', 'LastName': 'Elsayyad', 'Affiliation': 'Department of Physical Therapy for Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Nabil Mahmoud', 'Initials': 'NM', 'LastName': 'Abdel-Aal', 'Affiliation': 'Department of Physical Therapy for Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt. Electronic address: nabil.mahmoud@cu.edu.eg.'}, {'ForeName': 'Mohamed Elsayed', 'Initials': 'ME', 'LastName': 'Helal', 'Affiliation': 'Department of Physical Therapy, Sadat General Hospital, Monofia, Egypt.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.009']
1688,32827598,Parental-oriented educational mobile messages to aid in the control of early childhood caries in low socioeconomic children: A randomized controlled trial.,"OBJECTIVES


To evaluate the effectiveness of educational messages as an aid in the control of early childhood caries (ECC) in low socioeconomic children.
METHODS


A single-blinded, randomized, and parallel-group study was conducted with 104 dyads of parents and children aged between 36-60 months, recruited in preschools from Bauru, Brazil. The participants were randomly allocated into control and intervention groups (1:1), stratified by parental eHealth literacy scores (eHEALS) and children's caries experience. Every 2 weeks, text messages were sent to parents of intervention group via WhatsApp. Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS) were assessed at baseline, 3- and 6-month follow-ups, while eHEALS and dietary habits were determined at baseline and 6-month follow-up. Statistical analysis was performed to intra and intergroup comparisons through Fischer's exact and McNemar tests, and Mann-Whitney U and Friedman tests, respectively (P < 0.05).
RESULTS


Despite similarities between groups, intervention increased parental eHEALS scores, influencing the reports about the children's consumption of sugar-free sweets and controlling the severity of ECC.
CONCLUSION


Therefore, mobile text messages were effective to control the severity of ECC in low socioeconomic preschoolers, improving parental eHealth literacy and changing children's dietary patterns.
CLINICAL SIGNIFICANCE


These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.",2020,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"['low socioeconomic children', '104 dyads of parents and children aged between 36-60 months, recruited in preschools from (blinded']","['educational messages', 'parental-oriented mobile text messages', 'Parental-oriented educational mobile messages']","['Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS', 'parental eHEALS scores']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0747732,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Lotto', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Anna Paola', 'Initials': 'AP', 'LastName': 'Strieder', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Patricia Estefania', 'Initials': 'PE', 'LastName': 'Ayala Aguirre', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thais Marchini', 'Initials': 'TM', 'LastName': 'Oliveira', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Maria Aparecida', 'Initials': 'MA', 'LastName': 'Andrade Moreira Machado', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rios', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Cruvinel', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil. Electronic address: thiagocruvinel@fob.usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103456']
1689,32783554,Detection and False-Referral Rates of 2-mSv CT Relative to Standard-Dose CT for Appendiceal Perforation: Pragmatic Multicenter Randomized Controlled Trial.,"OBJECTIVE.  The objective of our study was to compare diagnostic performance of 2-mSv CT and standard-dose CT (SDCT) for the diagnosis of perforated appendicitis in adolescents and young adults.  MATERIALS AND METHODS.  We used the intention-to-treat analysis set of a pragmatic randomized controlled trial involving 3074 patients (age range, 15-44 years) with suspected appendicitis and 161 radiologists from 20 hospitals. The patients were randomized to undergo either 2-mSv CT or SDCT. Predefined endpoints were sensitivity and specificity. Considering potential verification bias caused by the difference in diagnostic interventions (2-mSv CT vs SDCT), we added endpoints of detection rate (DR) and false-referral rate. The reference standards were surgical or pathologic findings. We used Fisher exact tests. Sensitivity analyses included the following: first, a per-protocol analysis; second, an analysis of a surgical reference standard but not a pathologic reference standard; and, third, an analysis to adjust for site clustering. We tested for heterogeneity in DR and false-referral rate across various patient and hospital characteristics.  RESULTS.  The 2-mSv CT and SDCT groups were comparable regarding DR (5.1% [78/1535] vs 4.9% [76/1539]; 95% CI for the difference, -1.4 to 1.7 percentage points;  p  = 0.87), false-referral rate (3.1% [48/1535] vs 3.1% [47/1539]; 95% CI for the difference, -1.2 to 1.3 percentage points;  p  = 0.92), sensitivity (42.9% [78/182] vs 43.2% [76/176]; 95% CI for the difference, -10.6 to 9.9 percentage points;  p  > 0.99), and specificity (89.2% [305/342] vs 91.2% [354/388]; 95% CI for the difference, -6.4 to 2.3 percentage points;  p  = 0.38). Sensitivity analyses showed similar results. We found no significant subgroup heterogeneity.  CONCLUSION.  The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.",2020,"The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.","['3074 patients (age range, 15-44 years) with suspected appendicitis and 161 radiologists from 20 hospitals', 'adolescents and young adults']","['2-mSv CT and standard-dose CT (SDCT', 'SDCT', '2-mSv CT or SDCT', '2-mSv CT Relative to Standard-Dose CT']","['diagnostic performance', 'detection rate (DR) and false-referral rate', 'false-referral rate', 'sensitivity', 'specificity', 'sensitivity and specificity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",3074.0,0.282225,"The performance of 2-mSv CT, with limited sensitivity but high specificity, is comparable to that of SDCT for the diagnosis of appendiceal perforation.","[{'ForeName': 'Hae Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': 'Yousun', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'Biomedical Research Center, Asan Institute for Life Sciences, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': 'Kyoung Ho', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22632']
1690,32784231,Effect of low-dose lidocaine on objective upper extremity strength and immediate pain relief following cervical interlaminar epidural injections: a double-blinded randomized controlled trial.,"BACKGROUND


Low-dose lidocaine is a common diluent for analgesia following cervical interlaminar epidural steroid injection (CIESI). Concerns with this practice exist. A single-arm cohort reported that 20% of patients develop postprocedural upper extremity weakness when using lidocaine as a diluent. Furthermore, a high-cervical spinal block with unintended intrathecal or subdural administration is possible.
OBJECTIVE


Determine if low-dose lidocaine as a diluent during CIESI causes clinically meaningful (1) upper extremity weakness and (2) immediate pain relief when compared with saline.
DESIGN


Double-blinded randomized control trial.
METHODS


Patients with cervical radicular pain scheduled for CIESI were enrolled. Participants received lidocaine (CIESI-L) or saline (CIESI-S) as a diluent for the epidural injectate. Myotomal strength was measured with dynamometry before and between 20 and 30 min after CIESI. Pre-pain and post-pain scores were obtained. Primary and secondary outcomes were post-CIESI weakness of ≥20% (minimal clinically important difference (MCID)) in  > 1 myotome and ≥50% pain reduction on the numerical scale.
RESULTS


120 participants (64 females (53%), mean age, 56 (SD 13.7) years) completed the study and were analyzed (CIESI-L n=60; CIESI-S n=60). There was no significant between-group difference in the proportion of participants with postprocedural weakness, CIESI-L 41.7% (95% CI, 29.8% to 54.5%), CIESL-S 50% (95% CI, 37.5% to 62.5%). Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).
CONCLUSION


Low-dose lidocaine as a diluent in CIESI does not significantly increase the risk of post-CIESI myotomal weakness when compared with saline, but also does not substantially increase the likelihood of immediate, meaningful pain relief.
TRIAL REGISTRATION DETAILS


ClinicalTrials.gov (NCT03127137); December 26, 2017.",2020,"Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).
","['Patients with cervical radicular pain scheduled for CIESI were enrolled', 'cervical interlaminar epidural injections', '120 participants (64 females (53%), mean age, 56 (SD 13.7) years) completed the study and were analyzed (CIESI-L n=60; CIESI-S n=60']","['low-dose lidocaine', 'lidocaine', 'lidocaine (CIESI-L) or saline (CIESI-S']","['pain reduction', 'post-CIESI weakness of ≥20% (minimal clinically important difference (MCID)) in  > 1 myotome and ≥50%\u2009pain reduction on the numerical scale', 'objective upper extremity strength and immediate pain relief', 'postprocedural upper extremity weakness', 'risk of post-CIESI myotomal weakness', 'Myotomal strength', 'likelihood of immediate, meaningful pain relief', 'pain and post-pain scores', 'proportion of participants with postprocedural weakness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4552559', 'cui_str': 'Cervical radicular pain'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0231043', 'cui_str': 'Structure of myotome'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444463', 'cui_str': 'Myotomal'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.725452,"Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).
","[{'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'McCormick', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Orthopedic Surgery, University of Utah Hospital, Salt Lake City, Utah, USA zmccormi@gmail.com.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Burnham', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'Shellie', 'Initials': 'S', 'LastName': 'Cunningham', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Kendall', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bougie', 'Affiliation': 'Department of Anesthesiology, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Teramoto', 'Affiliation': 'Physical Medicine and Rehabilitation, University of Utah Hospital, Salt Lake City, Utah, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Walega', 'Affiliation': 'Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101598']
1691,32790671,Increasing adverse drug reaction reporting-How can we do better?,"Adverse drug reactions (ADRs) are associated with morbidity and mortality worldwide. Although national systems for reporting ADRs exist there is a low reporting rate. The aim of the current study was to evaluate an intervention plan for improving ADRs reporting among medical professionals (physicians and nurses). A multicentre intervention study was conducted, in which one medical centre was randomly assigned to the intervention group and two medical centres to the control group. The study consisted of 3 phases: baseline data collection, intervention and follow-up of the reporting rate. The questionnaire that was filled in at base line and at the end of study, contained questions about personal/professional demographic variables, and statements regarding knowledge of and behaviour toward ADRs reporting. The intervention program consisted of posters, lectures, distant electronic learning and reminders. An increase in the number of ADRs reports was noted in the intervention group (74 times higher than in the control group) during the intervention period, which was gradually decreased with as the study progressed (adjusted O.R = 74.1, 95% CI = 21.11-260.1, p<0.001). The changes in the ""knowledge related to behaviour"" (p = 0.01) and in the ""behaviour related to reporting"" (p<0.001) score was significantly higher in the intervention group. Specialist physicians and nurses (p<0.001), fulfilling additional positions (p<0.001) and those working in other places (p = 0.05) demonstrated a high rate of report. Lectures were preferable as a method to encourage ADRs reporting. The most convenient reporting tools were telephone and online reporting. Thus, implementation and maintenance of a continuous intervention program, by a pharmacovigilance specialist staff member, will improve ADRs reporting rates.",2020,"The changes in the ""knowledge related to behaviour"" (p = 0.01) and in the ""behaviour related to reporting"" (p<0.001) score was significantly higher in the intervention group.",['medical professionals (physicians and nurses'],"['posters, lectures, distant electronic learning and reminders']","['Adverse drug reactions (ADRs', 'number of ADRs reports']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0325042,"The changes in the ""knowledge related to behaviour"" (p = 0.01) and in the ""behaviour related to reporting"" (p<0.001) score was significantly higher in the intervention group.","[{'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Potlog Shchory', 'Affiliation': 'Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': 'Clinical Pharmacology Unit, Haemek Medical Center, Afula affiliated to The Bruce Rapapport School of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Arcavi', 'Affiliation': 'Clinical Pharmacology Unit, Kaplan Medical Center, Hebrew University and Hadassah Medical School, Rehovot, Jerusalem, Israel.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Shihmanter', 'Affiliation': 'Clinical Pharmacology Unit, Kaplan Medical Center, Hebrew University and Hadassah Medical School, Rehovot, Jerusalem, Israel.'}, {'ForeName': 'Matitiahu', 'Initials': 'M', 'LastName': 'Berkovitch', 'Affiliation': 'Clinical Pharmacology Unit, Shamir Medical Center (Assaf Harofeh), Zerifin, Affiliated to Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Levy', 'Affiliation': 'Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",PloS one,['10.1371/journal.pone.0235591']
1692,32797125,Ubiquinol supplementation modulates energy metabolism and bone turnover during high intensity exercise.,"Bone and energy metabolism are profoundly influenced by exercise. The objective of this study was to determine for the first time whether a short-term supplementation with ubiquinol could have a modulating effect on bone turnover and energy metabolism associated with strenuous exercise. The participants (n = 100 healthy and well-trained firemen) were randomly divided into two groups: ubiquinol group (ubiquinol (200 mg day-1)) and control group (placebo) for two weeks. The protocol consisted of conducting two identical strenuous exercise tests with a rest period between tests of 24 h. Blood samples were collected before supplementation (basal value) (T1), after supplementation (T2), after the first physical exercise test (T3), after 24 h of rest (T4), and after the second physical exercise test (T5). Parathyroid hormone (PTH), osteocalcin (OC), osteoprotegerin (OPG), osteopontin (OPN), sclerotin (SOST), alkaline phosphatase (AP), adrenocorticotropin (ACTH), insulin, leptin, adrenaline, noradrenaline and peroxisome proliferator activated receptor-γ coactivator-1α (PGC-1α) were determined. Our protocol increased ACTH, SOST, PTH and OC levels, while it decreased OPN. This protocol also increased adrenaline, noradrenaline and PCG-1α, and decreased insulin. After ubiquinol supplementation, PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels increased in the supplemented group compared to the control group after the exercise protocol. Strenuous exercise has a clear effect on energy metabolism and bone turnover. These effects are modulated by ubiquinol supplementation, which especially increases the biomarkers of bone formation during strenuous exercise. In addition, ubiquinol has a beneficial effect on the mobilization of energy sources, fact that it could represent an ergogenic and physiological advantage for skeletal muscles.",2020,"After ubiquinol supplementation, PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels increased in the supplemented group compared to the control group after the exercise protocol.",['participants (n = 100 healthy and well-trained firemen'],"['ubiquinol group (ubiquinol (200 mg day-1)) and control group (placebo', 'Ubiquinol supplementation', 'Strenuous exercise']","['Parathyroid hormone (PTH), osteocalcin (OC), osteoprotegerin (OPG), osteopontin (OPN), sclerotin (SOST), alkaline phosphatase (AP), adrenocorticotropin (ACTH), insulin, leptin, adrenaline, noradrenaline and peroxisome proliferator activated receptor-γ coactivator-1α (PGC-1α', 'Bone and energy metabolism', 'ACTH, SOST, PTH and OC levels', 'PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels', 'adrenaline, noradrenaline and PCG-1α, and decreased insulin', 'bone turnover and energy metabolism', 'energy metabolism and bone turnover']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}]","[{'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0069676', 'cui_str': 'Osteopontin'}, {'cui': 'C0074186', 'cui_str': 'sclerotin'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0265301', 'cui_str': 'Sclerosteosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030827', 'cui_str': 'Penicillin G'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",100.0,0.0563639,"After ubiquinol supplementation, PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels increased in the supplemented group compared to the control group after the exercise protocol.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Diaz-Castro', 'Affiliation': 'Department of Physiology, University of Granada, Granada, 18071, Spain and Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es.'}, {'ForeName': 'Pablo Javier', 'Initials': 'PJ', 'LastName': 'Mira-Rufino', 'Affiliation': 'Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es and Human Nutrition Ph.D. Program, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moreno-Fernandez', 'Affiliation': 'Department of Physiology, University of Granada, Granada, 18071, Spain and Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Chirosa', 'Affiliation': 'Department of Physical Education, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Javier Luis', 'Initials': 'JL', 'LastName': 'Chirosa', 'Affiliation': 'Department of Physical Education, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Guisado', 'Affiliation': 'Faculty of Health Sciences, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Julio J', 'Initials': 'JJ', 'LastName': 'Ochoa', 'Affiliation': 'Department of Physiology, University of Granada, Granada, 18071, Spain and Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es.'}]",Food & function,['10.1039/d0fo01147a']
1693,32798558,Dexmedetomidine alleviates non-ventilation associated lung injury via modulating immunology phenotypes of macrophages.,"AIMS


We aimed to evaluate the effect of Dexmedetomidine (Dex) on immunology function of macrophages and inflammatory reactions in non-ventilated lung tissues from both humans and rats.
MAIN METHODS


Patients scheduled for lung lobectomy were randomly assigned to traditional anesthesia group or Dex anesthesia group, 15 subjects in each group. CD68, CD86 and CD206 were used to mark activate and polarized macrophages using immunofluorescence staining in human lung tissues. Sprague-Dawley rats were used to set lung injury model and randomly divided into Control group, one-lung ventilation group (CLI group) and CLI + Dex group. Lung tissues and bronchoalveolar lavage fluid (BALF) from non-ventilated lungs were collected. The acquired lung tissues were subjected to hematoxylin-eosin (H&E) staining and the inflammatory cells in BALF were calculated. Levels of cytokines and chemokines were detected by enzyme-linked immunosorbent assays (ELISA).
KEY FINDINGS


Results from humans showed that anesthesia with Dex decreased the number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1) in human lung. Results from rats demonstrated that treatment with Dex reversed the increased inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif) ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
SIGNIFICANCE


This study showed that Dex modulated the activation and immunological function of macrophages in non-ventilated lung and revealed a protective role in collapsed lung injury.",2020,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","['Patients scheduled for lung lobectomy', 'non-ventilated lung tissues from both humans and rats']","['traditional anesthesia group or Dex anesthesia', 'Dexmedetomidine (Dex', 'Control group, one-lung ventilation group (CLI group) and CLI\u202f+\u202fDex group', 'Dexmedetomidine', 'Dex']","['inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif', 'Levels of cytokines and chemokines', 'immunology function of macrophages and inflammatory reactions', 'Lung tissues and bronchoalveolar lavage fluid (BALF', 'number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1', 'anti-inflammatory cytokine interleukin-10 (IL-10']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C1453673', 'cui_str': 'CLU protein, human'}]","[{'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0006279', 'cui_str': 'Bronchoalveolar lavage fluid sample'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0527903', 'cui_str': 'Lymphocyte antigen CD86'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",15.0,0.0272658,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","[{'ForeName': 'Qiying', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: shenqiying-yy@163.com.'}, {'ForeName': 'Guanghong', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China; Department of Anesthesiology, the Fourth Affiliated Hospital of Anhui Medical University, Hefei 230000, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yongqi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: liuxuesheng@ahmu.edu.cn.'}]",Life sciences,['10.1016/j.lfs.2020.118249']
1694,32798840,Mouse nerve growth factor promotes neurological recovery in patients with acute intracerebral hemorrhage: A proof-of-concept study.,"BACKGROUND


ew drugs were confirmed to be effective in the treatments of neurological dysfunction caused by acute intracerebral hemorrhage (ICH). The present prospective clinical trial aims to evaluate the effect of mouse nerve growth factor (mNGF) on neurological function in patients with acute ICH.
METHODS


60 patients with acute spontaneous ICH were randomized to receive mNGF (mNGF group) and citicoline (control group) for 4 weeks within 24-72 h after onset, respectively. The primary outcome was difference in the neurological functional outcome at 3 months by the modified Rankin Scale score (mRS). The secondary outcomes were the changes in hematoma volume at 4 weeks and 3 months.
RESULTS


There were 55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group). Among the patients, 46 patients finished the trial at 3 months; the odds of a shift towards death or dependence (mRS > 3) at 3 months in the mNGF group were lower than that in the control group with adjustment for age, sex, NIHSS at admission, and hematoma volume at admission (adjusted OR, 0.185; 95%CI, 0.059-0.582; P = 0.0039). The hematoma was gradually reduced in all 46 patients and absorbed after non-surgical treatment at 3 months. There was no significant difference in hematoma volume between the two groups. No serious adverse event was found.
CONCLUSIONS


The administration of mNGF and citicoline was well-tolerated in patients with acute ICH. mNGF was associated with improved neurological function and less disability in patients with ICH. Therefore, the quality of life of patients with ICH may be improved by mNGF.
TRIAL REGISTRATION


The trial is registered with the Chinese Clinical Trial Registry, number ChiCTR1800020258.",2020,There was no significant difference in hematoma volume between the two groups.,"['patients with acute ICH', 'patients with acute intracerebral hemorrhage', '55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group', '60 patients with acute spontaneous ICH', 'patients with ICH']","['mNGF and citicoline', 'mNGF', 'mNGF (mNGF group) and citicoline (control group', 'mouse nerve growth factor (mNGF', 'Mouse nerve growth factor']","['quality of life', 'neurological functional outcome', 'hematoma', 'modified Rankin Scale score (mRS', 'changes in hematoma volume', 'neurological function', 'hematoma volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",60.0,0.0533032,There was no significant difference in hematoma volume between the two groups.,"[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yingsheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yongyue', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Laboratory of Neuro-Trauma and Neurodegenerative Disorders, Tianjin Geriatrics Institute, Tianjin Medical University General Hospital, Tianjin, China; Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jianningzhang@hotmail.com.'}, {'ForeName': 'Rongcai', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jiang116216@163.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117069']
1695,32798927,A randomized controlled trial of 25 sessions comparing music therapy and music listening for children with autism spectrum disorder.,"BACKGROUND


Music therapy is based on the use of musical elements by a trained and qualified therapist. Clinical researches have suggested that children with Autism Spectrum Disorders (ASD) may benefit from MT. In this regard, this study examines if MT is more effective than simply listening to music for children with ASD.
METHOD


A 8-month RCT has been carried out comparing music therapy (MT) to music listening (ML) for children with ASD aged from 4 to 7 years old. Thirty-seven participants were randomly assigned to one of the two groups (MT vs. ML). The outcome measures were the Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML).
RESULTS


CGI scores decreased more for participants in the MT than in the ML condition. This clinical improvement was associated with an improvement of autistic symptoms on lethargy and stereotypy ABC subscales.
CONCLUSION


Our findings suggest that music therapy is more efficient than music listening for children with ASD. The present study thus supports the consideration of MT as a rightful add-on to ASD healthcare programs.",2020,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","['children with ASD', 'children with ASD aged from 4 to 7 years old', 'children with autism spectrum disorder', 'Thirty-seven participants', 'children with Autism Spectrum Disorders (ASD']","['MT', 'music therapy', 'music therapy and music listening', 'music therapy (MT) to music listening (ML']","['autistic symptoms on lethargy and stereotypy ABC subscales', 'Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML', 'CGI scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319569', 'cui_str': '37'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",37.0,0.0933362,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rabeyron', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France. Electronic address: thomas.rabeyron@univ-lorraine.fr.'}, {'ForeName': 'Juan-Pablo', 'Initials': 'JP', 'LastName': 'Robledo Del Canto', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre for Music and Science, University of Cambridge, United Kingdom.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Carasco', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bisson', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bodeau', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Vrait', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Berna', 'Affiliation': 'Université de Strasbourg, Hôpitaux Universitaires de Strasbourg, Inserm U1114, France; Collègue Universitaire des Médecines Intégratives et Complémentaires (CUMIC), Nantes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bonnot', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}]",Psychiatry research,['10.1016/j.psychres.2020.113377']
1696,32800029,[Effect of intermittent versus daily inhalation of budesonide on pulmonary function and fractional exhaled nitric oxide in children with mild persistent asthma].,"OBJECTIVE


To study the effect of intermittent versus daily inhalation of budesonide on pulmonary function and fractional exhaled nitric oxide (FeNO) in children with mild persistent asthma.
METHODS


A total of 120 children, aged 6-14 years, with mild persistent asthma who attended the hospital from January 2016 to January 2018 were enrolled. The children were divided into an intermittent inhalation group with 60 children (inhalation of budesonide 200 μg/day for 6 weeks when symptoms of asthma appeared) and a daily inhalation group with 60 children (continuous inhalation of budesonide 200 μg/day) by stratified randomization. The children were followed up at months 3, 6, 9, and 12 of treatment. The two groups were compared in terms of baseline data, changes in FeNO and pulmonary function parameters, amount of glucocorticoid used, number of asthma attacks, and asthma control.
RESULTS


At the start of treatment, there were no significant differences in baseline data, FeNO, and pulmonary function between the two groups (P>0.05). Over the time of treatment, FeNO gradually decreased and pulmonary function parameters were gradually improved in both groups (P<0.001). Compared with the intermittent inhalation group, the daily inhalation group had a better effect in reducing FeNO and increasing the predicted percentage of forced expiratory volume in 1 second (FEV1%pred) (P<0.001). The inhalation method and treatment time had an interaction effect on FeNO and pulmonary function parameters (P<0.001). In the daily inhalation group, FeNO and lung function parameters were improved rapidly and stabilized after 3 months of treatment, while those in the intermittent inhalation group stabilized after 6 months. After 12 months of treatment, there were no significant differences in the increases in body height and body weight and the degree of disease control between the two groups (P>0.05). Compared with the daily inhalation group, the intermittent inhalation group had a significantly lower amount of budesonide inhaled (P<0.05) and a significantly higher number of asthma attacks (P<0.05).
CONCLUSIONS


Intermittent inhalation and daily inhalation of budesonide can achieve the same level of asthma control in children with mild persistent asthma and both have no influence on the increases in body height and body weight. Daily inhalation of budesonide can produce a better efficiency in reduing FeNO and increasing FEV1%pred. Although intermittent inhalation can reduce the amount of glucocorticoid used, it may lead to a higher risk of asthma attacks.",2020,The inhalation method and treatment time had an interaction effect on FeNO and pulmonary function parameters (P<0.001).,"['children with mild persistent asthma', '120 children, aged 6-14 years, with mild persistent asthma who attended the hospital from January 2016 to January 2018 were enrolled']","['intermittent inhalation group with 60 children (inhalation of budesonide 200\u2005μg/day for 6 weeks when symptoms of asthma appeared) and a daily inhalation group with 60 children (continuous inhalation of budesonide', 'budesonide']","['pulmonary function and fractional exhaled nitric oxide', 'FeNO and lung function parameters', 'number of asthma attacks', 'baseline data, FeNO, and pulmonary function', 'forced expiratory volume', 'body height and body weight and the degree of disease control', 'pulmonary function and fractional exhaled nitric oxide (FeNO', 'FeNO and pulmonary function parameters', 'FeNO', 'pulmonary function parameters', 'body height and body weight', 'FeNO and pulmonary function parameters, amount of glucocorticoid used, number of asthma attacks, and asthma control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1960046', 'cui_str': 'Mild persistent asthma'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0347950', 'cui_str': 'Acute exacerbation of asthma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",120.0,0.0254881,The inhalation method and treatment time had an interaction effect on FeNO and pulmonary function parameters (P<0.001).,"[{'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatrics, Fifth People's Hospital of Shanghai, Fudan University, Shanghai 200240, China. wxmyj@sina.com.""}, {'ForeName': 'Wen-Xuan', 'Initials': 'WX', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Wang', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
1697,32800099,"Effect of mammographic screening from age 40 years on breast cancer mortality (UK Age trial): final results of a randomised, controlled trial.","BACKGROUND


The appropriate age range for breast cancer screening remains a matter of debate. We aimed to estimate the effect of mammographic screening at ages 40-48 years on breast cancer mortality.
METHODS


We did a randomised, controlled trial involving 23 breast screening units across Great Britain. We randomly assigned women aged 39-41 years, using individual randomisation, stratified by general practice, in a 1:2 ratio, to yearly mammographic screening from the year of inclusion in the trial up to and including the calendar year that they reached age 48 years (intervention group), or to standard care of no screening until the invitation to their first National Health Service Breast Screening Programme (NHSBSP) screen at approximately age 50 years (control group). Women in the intervention group were recruited by postal invitation. Women in the control group were unaware of the study. The primary endpoint was mortality from breast cancers (with breast cancer coded as the underlying cause of death) diagnosed during the intervention period, before the participant's first NHSBSP screen. To study the timing of the mortality effect, we analysed the results in different follow-up periods. Women were included in the primary comparison regardless of compliance with randomisation status (intention-to-treat analysis). This Article reports on long-term follow-up analysis. The trial is registered with the ISRCTN registry, ISRCTN24647151.
FINDINGS


160 921 women were recruited between Oct 14, 1990, and Sept 24, 1997. 53 883 women (33·5%) were randomly assigned to the intervention group and 106 953 (66·5%) to the control group. Between randomisation and Feb 28, 2017, women were followed up for a median of 22·8 years (IQR 21·8-24·0). We observed a significant reduction in breast cancer mortality at 10 years of follow-up, with 83 breast cancer deaths in the intervention group versus 219 in the control group (relative rate [RR] 0·75 [95% CI 0·58-0·97]; p=0·029). No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
INTERPRETATION


Yearly mammography before age 50 years, commencing at age 40 or 41 years, was associated with a relative reduction in breast cancer mortality, which was attenuated after 10 years, although the absolute reduction remained constant. Reducing the lower age limit for screening from 50 to 40 years could potentially reduce breast cancer mortality.
FUNDING


National Institute for Health Research Health Technology Assessment programme.",2020,"No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
","['from age 40 years on breast cancer mortality (UK Age trial', '160\u2008921 women were recruited between Oct 14, 1990, and Sept 24, 1997', '23 breast screening units across Great Britain', 'at ages 40-48 years on breast cancer mortality', 'women aged 39-41 years, using individual randomisation, stratified by general practice, in a 1:2 ratio, to yearly mammographic screening from the year of inclusion in the trial up to and including the calendar year that they reached age 48 years (intervention group), or to', '53\u2008883 women (33·5']","['mammographic screening', 'standard care of no screening until the invitation to their first National Health Service Breast Screening Programme (NHSBSP) screen']","['breast cancer mortality', 'mortality from breast cancers (with breast cancer coded as the underlying cause of death', 'mortality effect']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0018223', 'cui_str': 'Great Britain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456586', 'cui_str': 'Calendar year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",23.0,0.112667,"No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
","[{'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK. Electronic address: s.w.duffy@qmul.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vulkan', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cuckle', 'Affiliation': 'Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dharmishta', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Shama', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Smith', 'Affiliation': 'American Cancer Society, Atlanta, GA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Division of Cancer Research, University of Dundee, Dundee, UK.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Blyuss', 'Affiliation': 'School of Physics, Astronomy, and Mathematics, University of Hertfordshire, Hatfield, UK; Department of Paediatrics and Paediatric Infectious Diseases, Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Ian O', 'Initials': 'IO', 'LastName': 'Ellis', 'Affiliation': 'Division of Cancer and Stem Cells, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myles', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Sasieni', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30398-3']
1698,32800815,Randomized Controlled Early versus Late Ventricular Intervention Study in Posthemorrhagic Ventricular Dilatation: Outcome at 2 Years.,"OBJECTIVE


To compare the effect of intervention at low vs high threshold of ventriculomegaly in preterm infants with posthemorrhagic ventricular dilatation on death or severe neurodevelopmental disability.
STUDY DESIGN


This multicenter randomized controlled trial reviewed lumbar punctures initiated after either a low threshold (ventricular index of >p97 and anterior horn width of >6 mm) or high threshold (ventricular index of >p97 + 4 mm and anterior horn width of >10 mm). The composite adverse outcome was defined as death or cerebral palsy or Bayley composite cognitive/motor scores <-2 SDs at 24 months corrected age.
RESULTS


Outcomes were assessed in 113 of 126 infants. The composite adverse outcome was seen in 20 of 58 infants (35%) in the low threshold group and 28 of 55 (51%) in the high threshold (P = .07). The low threshold intervention was associated with a decreased risk of an adverse outcome after correcting for gestational age, severity of intraventricular hemorrhage, and cerebellar hemorrhage (aOR, 0.24; 95% CI, 0.07-0.87; P = .03). Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference, -0.06; 95% CI, -0.09 to -0.03; P < .001) at term-equivalent age. Infants in the low threshold group with a ventriculoperitoneal shunt, had cognitive and motor scores similar to those without (P = .3 for both), whereas in the high threshold group those with a ventriculoperitoneal shunt had significantly lower scores than those without a ventriculoperitoneal shunt (P = .01 and P = .004, respectively).
CONCLUSIONS


In a post hoc analysis, earlier intervention was associated with a lower odds of death or severe neurodevelopmental disability in preterm infants with progressive posthemorrhagic ventricular dilatation.
TRIAL REGISTRATION


ISRCTN43171322.",2020,"Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference: -0.06, 95% CI","['preterm infants with posthemorrhagic ventricular dilatation on death or severe neurodevelopmental disability', 'Posthemorrhagic Ventricular Dilatation', 'preterm infants with progressive posthemorrhagic ventricular dilatation']","['LT intervention', 'Late Ventricular Intervention Study (ELVIS']","['death or severe neurodevelopmental disability', 'intraventricular hemorrhage and cerebellar hemorrhage', 'cognitive and motor scores', 'risk of an adverse outcome', 'composite adverse outcome', 'death or cerebral palsy or Bayley composite cognitive/motor scores <-2 standard deviations', 'smaller fronto-occipital horn ratio']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4552505', 'cui_str': 'PHVD'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0648185', 'cui_str': 'glutamyl-leucyl-valyl-isoleucyl-serine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0149854', 'cui_str': 'Cerebellar hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0152282', 'cui_str': 'Structure of posterior horn of lateral ventricle'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.200645,"Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference: -0.06, 95% CI","[{'ForeName': 'Mehmet N', 'Initials': 'MN', 'LastName': 'Cizmeci', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands; Division of Neonatology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Floris', 'Initials': 'F', 'LastName': 'Groenendaal', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands.""}, {'ForeName': 'Kian D', 'Initials': 'KD', 'LastName': 'Liem', 'Affiliation': ""Department of Neonatology, Amalia Children's Hospital, Radboud University Medical Center, Nijmegen, the Netherlands.""}, {'ForeName': 'Ingrid C', 'Initials': 'IC', 'LastName': 'van Haastert', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Benavente-Fernández', 'Affiliation': ""Department of Neonatology, 'Puerta del Mar' University Hospital, Cadiz, Spain.""}, {'ForeName': 'Henrica L M', 'Initials': 'HLM', 'LastName': 'van Straaten', 'Affiliation': ""Department of Neonatology, Isala Women and Children's Hospital, Zwolle, the Netherlands.""}, {'ForeName': 'Sylke', 'Initials': 'S', 'LastName': 'Steggerda', 'Affiliation': 'Department of Neonatology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Bert J', 'Initials': 'BJ', 'LastName': 'Smit', 'Affiliation': 'Directorate Quality & Patient Care, Erasmus MC, University Medical Center Rotterdam, the Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Whitelaw', 'Affiliation': 'Neonatal Intensive Care Unit, Southmead Hospital and Neonatal Neuroscience, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Woerdeman', 'Affiliation': 'Division of Neuroscience, Department of Neurosurgery, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Heep', 'Affiliation': 'Neonatal Intensive Care Unit, Southmead Hospital and Neonatal Neuroscience, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'de Vries', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center; Utrecht; University Medical Center Utrecht, Utrecht Brain Center, Utrecht, the Netherlands. Electronic address: l.s.devries@umcutrecht.nl.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.014']
1699,32802319,Effects of rehabilitation training on an elderly population with mild to moderate hearing loss: study protocol for a randomised clinical trial.,"Background:  Age-related hearing loss (presbycusis) is a form of hearing loss in over 60-years-olds and has a negative impact on quality of life. Presbycusis is multifactorial and is predominately characterised with a loss of speech perception in noise. In the cochlea, auditory filters decompose broadband sound into a series of narrowband output signals, which contains two kinds of temporal information: slow changes in overall amplitude envelope (ENV) and faster variations in temporal fine structure (TFS). TFS is important for recognition of target speech in noise. The main aim of the study is to evaluate the effect of TFS rehabilitation training in participants over the age of 60 years with mild to moderate hearing loss.  Methods:  A randomised clinical trial  conducted on 30 participants with mild (loss of 20-39dB HL) to moderate (40-69dB HL) hearing loss, aged between 60 and 75 years old. Participants with conductive hearing loss, abnormal middle ear pathology and central nervous system disease were excluded. Participants were selected randomly  to an intervention and control group with a 1:1 ratio. Rehabilitation for the intervention Group are 30-minute sessions three times a week for a total five weeks of vowel consonant vowel words that are used to eliminate ENV and keep only TFS. Word in noise test, binaural TFS test, and Speech, Spatial and Qualities of Hearing Scale scores are performed at the beginning and end of study to evaluate the effect of rehabilitation training.  Conclusion:   Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis. A literature review highlighted that TFS damage is permanent; however, in this study we will attempt to prove that TFS training may lead to speech in noise perception improvement.  Trial registration:  Registry of Clinical Trials, IRCT2019625044006N1 (7  th  August 2019).",2020,"Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis.","['participants over the age of 60 years with mild to moderate hearing loss', '30 participants with mild (loss of 20-39dB) to moderate (40-69dB) hearing loss, aged between 60 and 75 years old', 'elderly population with mild to moderate hearing loss', 'Participants with conductive hearing loss, abnormal middle ear pathology and central nerve system disease']","['rehabilitation training', 'TFS training', 'TFS rehabilitation training', 'TFS']","['Word in noise test, binaural TFS test, and Speech, Spatial and Qualities of Hearing Scale scores', 'Life expectancy']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1852284', 'cui_str': 'Mild to moderate hearing loss'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",30.0,0.067655,"Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis.","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rasouli Fard', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Farnoush', 'Initials': 'F', 'LastName': 'Jarollahi', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Seyyed Jalal', 'Initials': 'SJ', 'LastName': 'Sameni', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamali', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}]",F1000Research,['10.12688/f1000research.23332.3']
1700,32805700,"The effect of circadian-adjusted LED-based lighting on sleep, daytime sleepiness and biomarkers of inflammation in a randomized controlled cross-over trial by pragmatic design in elderly care home dwellers.","AIM


Elderly multimorbid care home dwellers are a heterogenic group of frail individuals that exhibit sleep disturbances and a range of co-morbidities. The project aimed to study the possible effect of indoor circadian-adjusted LED-lighting (CaLED) in the elderly residents' care home on their sleeping patterns and systemic biomarkers associated with inflammation.
METHODS


A 16-week trial study was performed to follow the intervention and control groups using the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) to monitor sleep and daytime sleepiness, and biomarkers IL-6, TNF-α and suPAR, to estimate the levels of inflammation.
RESULTS


There was no significant impact on sleep improvement after the short intervention time when analyzing the PSQI and ESS results. However, we found several challenges using these tools for this specific group of individuals. Thus, important knowledge was gained for future studies in elderly care home dwellers. The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention. This study represents a first-to-date attempt to ameliorate the adverse effects of sleep disturbances that characterize a randomly chosen group of elderly multimorbid subjects, by using circadian-adjusted LED-lighting in a natural care home environment.
CONCLUSION


In this pragmatic randomized study of home dwelling individuals we were not able to demonstrate an improved sleep pattern as judged by PSQI, ESS or a change in inflammatory state.",2020,The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention.,"['elderly care home dwellers', ""elderly residents' care home on their sleeping patterns and systemic biomarkers associated with inflammation"", 'elderly multimorbid subjects, by using circadian-adjusted LED-lighting in a natural care home environment', 'Elderly multimorbid care home dwellers are a heterogenic group of frail individuals that exhibit sleep disturbances and a range of co-morbidities', 'home dwelling individuals']","['indoor circadian-adjusted LED-lighting (CaLED', 'circadian-adjusted LED-based lighting']","['sleep improvement', 'inflammation state', 'sleep, daytime sleepiness and biomarkers of inflammation', 'Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) to monitor sleep and daytime sleepiness, and biomarkers IL-6, TNF-α and suPAR, to estimate the levels of inflammation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0167666,The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention.,"[{'ForeName': 'Christine Borgen', 'Initials': 'CB', 'LastName': 'Linander', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: christine.borgen.linander@regionh.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: thomas.kallemose@regionh.dk.'}, {'ForeName': 'Lillian Moerch', 'Initials': 'LM', 'LastName': 'Joergensen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark; The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: lillian.moerch.joergensen@regionh.dk.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark; The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: ove.andersen@regionh.dk.'}, {'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Nehlin', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: jan.nehlin@regionh.dk.'}, {'ForeName': 'Baker Nawfal', 'Initials': 'BN', 'LastName': 'Jawad', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: baker.jawad@regionh.dk.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104223']
1701,32808888,Quantitative Muscle MRI Depicts Increased Muscle Mass after a Behavioral Change in Myotonic Dystrophy Type 1.,"Background Patients with myotonic dystrophy type 1 (DM1) increased their physical activity and exercise capacity following a behavioral intervention. However, it is unknown what is altered in muscles of patients with DM1 as a result of this intervention. The increased exercise capacity suggests that decelerated fat infiltration or increased muscle cross-sectional area (CSA) could be involved. Purpose To assess the effect of this activity-stimulating behavioral intervention on the lower extremity muscles of patients with DM1 with longitudinal quantitative muscle MRI. Materials and Methods In this prospective trial, participants with DM1 were randomized to a behavioral intervention ( n  = 14) or continued regular care (standard care;  n  = 13); no age-matched pairing was performed. Participants underwent MRI of the lower extremities at baseline and 10-month follow-up (January 2015 to March 2016). Fat fraction (FF), muscle CSA, and muscle water T2 (T2 water ) as markers for fat infiltration, muscle mass, and alteration in tissue water distribution (edema), respectively, were assessed with a chemical shift-encoded Dixon sequence and multiecho spin-echo sequence. Longitudinal within-group and between-group changes were assessed with paired-samples  t  tests and multivariable regression models. Results A total of 27 patients with DM1 (15 men) were evaluated. Patient age was comparable between groups (intervention, 45 years ± 13 [standard deviation]; standard care, 5 years ± 12;  P  = .96). Muscle CSA increased 5.9 cm 2  ± 7.8 in the intervention group during the 10-month follow-up ( P  = .03) and decreased 3.6 cm 2  ± 7.2 in the standard care group ( P  = .13). After 10 months, the mean difference between the groups was 9.5 cm 2  ( P  = .01). This effect was stronger in muscles with baseline FF below the mean ± standard deviation of unaffected volunteers (-0.4 cm 2  ± 0.15;  P  < .001). FF increased 0.9% ± 1.0 in the intervention group ( P  = .02) and 1.2% ± 1.2 for standard care ( P  = .02), with no between-group difference ( P  = .56). T2 water  did not change significantly in either group (intervention,  P  = .08; standard care,  P  = .88). Conclusion A behavioral intervention targeting physical activity increased lower extremity muscle cross-sectional area in patients with myotonic dystrophy, preferentially in healthy-appearing muscle. © RSNA, 2020  Online supplemental material is available for this article.",2020,"T2 water  did not change significantly in either group (intervention,  P  = .08; standard care,  P  = .88).","[' Patients with myotonic dystrophy type 1 (DM1', 'participants with DM1', 'patients with DM1 with longitudinal quantitative muscle MRI', 'patients with myotonic dystrophy, preferentially in healthy-appearing muscle', '27 patients with DM1 (15 men']","['activity-stimulating behavioral intervention', 'behavioral intervention ( n  = 14) or continued regular care (standard care;  n  = 13); no age-matched pairing', 'behavioral intervention targeting physical activity']","['physical activity and exercise capacity', 'Fat fraction (FF), muscle CSA, and muscle water T2 (T2 water ) as markers for fat infiltration, muscle mass, and alteration in tissue water distribution (edema', 'Muscle CSA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027126', 'cui_str': 'Steinert myotonic dystrophy syndrome'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",27.0,0.0445056,"T2 water  did not change significantly in either group (intervention,  P  = .08; standard care,  P  = .88).","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Heskamp', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Okkersen', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'van Nimwegen', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Marieke J', 'Initials': 'MJ', 'LastName': 'Ploegmakers', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bassez', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Deux', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Baziel G', 'Initials': 'BG', 'LastName': 'van Engelen', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Arend', 'Initials': 'A', 'LastName': 'Heerschap', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}]",Radiology,['10.1148/radiol.2020192518']
1702,32829945,Chronic Resistance Exercise Improves Functioning and Reduces Toll-Like Receptor Signaling in Elderly Patients With Postoperative Deconditioning.,"OBJECTIVE


Elderly patients continue to experience low levels of mobility during and following postoperative hospitalization that lead to persistent physical decline. Therefore, here we compared chronic resistance (CR) exercise against chronic aerobic (CA) exercise in ameliorating postoperative functioning and reducing proinflammatory muscular Toll-like receptor (TLR)-associated signaling in elderly postoperative patients.
METHODS


We conducted a prospective, randomized trial comparing the effects of 3 exercise programs (CR, CA, and CR + CA) in 66 elderly patients recovering from recent hip, femur, or pelvic fracture repair surgery. The primary outcomes were changes in anatomic/physical performance parameters (ie, maximal oxygen intake, endurance, quadriceps cross-sectional area, and maximum knee-extensor force). The secondary outcomes were changes in TLR/nuclear factor kappa beta signaling pathway marker expression.
RESULTS


Three of the 4 anatomic/physical performance parameters significantly improved for the CR and CR + CA cohorts. Muscular expression of myeloid differentiation primary response gene 88, transforming growth factor beta-activated kinase 1 (TLR signaling pathway markers), p50, p65, tumor necrosis factor α, and interleukin 6 (nuclear factor kappa beta signaling pathway markers) all showed significant reductions after CR and CR + CA. Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A, also showed significant reductions after CR and CR + CA.
CONCLUSIONS


Three months of CR or CR + CA improves maximal oxygen consumption, quadriceps cross-sectional area, and maximum knee-extensor force while lowering muscular proinflammatory signaling markers in elderly adults with postoperative deconditioning.",2020,"Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A, also showed significant reductions after CR and CR + CA.
","['elderly postoperative patients', 'Elderly Patients With Postoperative Deconditioning', 'elderly adults with postoperative deconditioning', 'Elderly patients', '66 elderly patients recovering from recent hip, femur, or pelvic fracture repair surgery']","['\u202fCA', 'Chronic Resistance Exercise', 'chronic resistance (CR) exercise against chronic aerobic (CA) exercise', '3 exercise programs (CR, CA, and CR\u202f+\u202fCA']","['changes in TLR/nuclear factor kappa beta signaling pathway marker expression', 'changes in anatomic/physical performance parameters (ie, maximal oxygen intake, endurance, quadriceps cross-sectional area, and maximum knee-extensor force', 'maximal oxygen consumption, quadriceps cross-sectional area, and maximum knee-extensor force', 'Muscular expression of myeloid differentiation primary response gene 88, transforming growth factor beta-activated kinase 1 (TLR signaling pathway markers), p50, p65, tumor necrosis factor α, and interleukin 6 (nuclear factor kappa beta signaling pathway markers', 'physical performance parameters', 'Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0149531', 'cui_str': 'Fracture of pelvis'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0439677', 'cui_str': 'Myeloid'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0379816', 'cui_str': 'MAP kinase kinase kinase 7'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0219874', 'cui_str': 'p50(csk)'}, {'cui': 'C0299809', 'cui_str': 'PAK2 Kinase'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0243043', 'cui_str': 'Heat-Shock Proteins 70'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}]",66.0,0.0703044,"Serum expression of 2 key TLR4 ligands, heat shock protein 70 and serum amyloid A, also showed significant reductions after CR and CR + CA.
","[{'ForeName': 'Yanbing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Training, Sports Institute, Zhengzhou University, Zhengzhou, Henan, China. Electronic address: m18530021718@163.com.'}, {'ForeName': 'Xiaohai', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Rehabilitation Medicine, Hainan Provincial People's Hospital, Haikou, Hainan, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Sports Rehabilitation, Sports Institute, Zhengzhou University, Zhengzhou, Henan, China.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2020.01.001']
1703,32830383,Skin-cleaning among hospitalized people who inject drugs: a randomized controlled trial.,"AIMS


To test the hypothesis that among hospitalized people who inject drugs (PWID), a brief intervention in skin-cleaning would result in greater reductions in follow-up emergency department (ED) or hospitalization rates compared with a usual care condition.
DESIGN


Randomized, two-group (intervention, n = 128; usual care, n = 124), single-site clinical trial with12-month follow-up.
SETTING


Hospital inpatient services in Boston, Massachusetts, United States.
PARTICIPANTS


People who injected drugs on at least 3 days each week prior to hospital admission (n = 252). Participants averaged 37.9 (± 10.7) years of age; 58.5% were male, 59.3% were white and 61.1% had a diagnosis related to skin infection at enrollment.
INTERVENTION AND COMPARATOR


Intervention was a skin hygiene education and skills-training behavioral intervention [short-term efficacy data on a behavioral intervention (SKIN)] consisting of two education- and skills-based skin-cleaning sessions, one during hospitalization and another 4 weeks later. The comparator was treatment as usual: an informational brochure about substance use treatment options and needle exchange programs in the area and follow-up clinical appointments as arranged by the inpatient medical staff.
MEASUREMENTS


Electronic medical records were reviewed and discharge diagnoses for each ED visit and hospital admission were categorized into injection-related bacterial events (e.g. cellulitis) and non-injection-related events. Negative binomial regression was used to test the intervention effects for the primary outcome and total ED visits, as well as the secondary outcomes, total number of hospitalizations, injection drug use-related (IDU-related) ED visits and IDU-related hospitalizations. We also tested whether the outcomes were moderated by whether the initial hospitalization was IDU-related.
FINDINGS


Of people assigned to SKIN, 66 completed two sessions, 55 completed one session and seven completed zero sessions. Adjusting for baseline covariates, the mean rate of total ED visits in the next 12 months was non-significantly higher [incidence rate ratio (IRR) = 1.13, 95% confidence interval (CI) = 0.96, 1.33, P = 0.152] compared with usual treatment. The intervention did not significantly reduce total hospitalizations or IDU-related hospitalizations. Adjusting for baseline covariates, the mean rate of injection drug use-related ED visits in the next 12 months was lower (IRR = 0.57, 95% CI = 0.35, 0.91, P = 0.019) compared with treatment as usual.
CONCLUSIONS


A skin-cleaning intervention for people who inject drugs delivered during a hospitalization did not significantly reduce either overall emergency department use or hospitalization. There was some evidence that it may have reduced injection drug use-related emergency department visits.",2020,"CONCLUSIONS


A skin-cleaning intervention for people who inject drugs delivered during a hospitalization did not significantly reduce either overall emergency department use or hospitalization.","['n=128; usual care, n=124), single site clinical trial with12-month follow-up', 'hospitalized people who inject drugs (PWID', 'Hospitalized Persons', 'Hospital inpatient services in Boston, Massachusetts, USA.\nPARTICIPANTS\n\n\nPersons who injected drugs on at least 3 days each week prior to hospital admission (n=252', 'Participants averaged 37.9 (± 10.7) years of age, 58.5% were male, 59.3% were white, and 61.1% had a diagnosis related to skin infection at enrollment']","['Inject Drugs', 'Skin Cleaning', 'SKIN', 'skin hygiene education and skills-training behavioral intervention (SKIN) consisting of two education and skills-based skin-cleaning sessions', 'skin-cleaning intervention', 'informational brochure about substance use treatment options and needle exchange programs']","['discharge diagnoses for each ED visit and hospital admission were categorized into injection-related bacterial events (e.g., cellulitis) and non-injection-related events', 'total hospitalizations or IDU-related hospitalisations', 'mean rate of total ED visits', 'mean rate of injection drug use related ED visits', 'total ED visits, as well as the secondary outcomes, total number of hospitalizations, injection drug use related (IDU-related) ED visits, and IDU-related hospitalizations', 'overall emergency department use or hospitalization']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1286234', 'cui_str': 'Skin hygiene'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0574729', 'cui_str': 'Skin clean'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0150359', 'cui_str': 'Substance use therapy'}, {'cui': 'C0242883', 'cui_str': 'Syringe-Exchange Programs'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0020811', 'cui_str': 'Idoxuridine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.061035,"CONCLUSIONS


A skin-cleaning intervention for people who inject drugs delivered during a hospitalization did not significantly reduce either overall emergency department use or hospitalization.","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Stein', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Kristina T', 'Initials': 'KT', 'LastName': 'Phillips', 'Affiliation': 'Center for Integrated Health Care Research, Kaiser Permanente Hawaii, Honolulu, HI, USA.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Herman', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Keosaian', 'Affiliation': 'Boston University School of Public Health, Boston, MA,, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'Boston University School of Public Health, Boston, MA,, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Behavioral Medicine and Addictions Research, Butler Hospital, Providence, RI, USA.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Weinstein', 'Affiliation': 'Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Liebschutz', 'Affiliation': 'Division of General Internal Medicine, Center for Research on Health Care, University of Pittsburgh, Pittsburgh, PA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15236']
1704,32794582,"Oral 3-hydroxybutyrate ingestion decreases endogenous glucose production, lipolysis, and hormone-sensitive lipase phosphorylation in adipose tissue in men: a human randomized, controlled, crossover trial.","AIMS


To test whether oral administration of D/L-3-hydroxybutyrate as a sodium salt inhibits lipolysis and intracellular lipid signalling, in particular, hormone-sensitive lipase, and whether D/L-3-hydroxybutyrate alters endogenous glucose production.
METHODS


We studied six young men in a randomized, controlled, crossover study after ingestion of Na-D/L-3-hydroxybutyrate (hyperketotic condition) or saline (placebo control). We quantified lipolysis and endogenous glucose production using [9,10- 3  H]-palmitate and [3-3H]glucose tracers, and adipose tissue biopsies were collected to investigate key lipolytic enzymes.
RESULTS


After ingestion, D/L-3-hydroxybutyrate increased by more than 2.5 mmol/l, free fatty acid concentrations decreased by >70%, and palmitate rate of appearance was halved. Protein kinase A phosphorylation of perilipin was reduced and hormone-sensitive lipase 660 phosphorylation in adipose tissue biopsies was 70-80% decreased in the hyperketotic condition and unchanged in the control. Compared to the control, endogenous glucose production was reduced by close to 20% (P<0.05) after 3-hydroxybutyrate ingestion.
CONCLUSION


We conclude that oral D/L-Na-3-hydroxybutyrate increases D/L-3-hydroxybutyrate concentrations within half an hour, decreases free fatty acid concentrations, lowers lipolysis and endogenous glucose production, and dephosphorylates hormone-sensitive lipase. Collectively these phenomena may be viewed as an orchestrated feedback loop, controlling endogenous glucose production, lipolysis and ketogenesis. Such effects would be beneficial in insulin-resistant states. (www.clini​caltr​ials.gov ID number: NCT02917252).",2020,"Compared to the control, endogenous glucose production was reduced by close to 20% (P<0.05) after 3-hydroxybutyrate ingestion.
","['adipose tissue in men', 'six young men']","['ingestion of Na-D/L-3-hydroxybutyrate (hyperketotic condition) or saline (placebo control', 'Oral 3-hydroxybutyrate ingestion', 'oral D/L-Na-3-hydroxybutyrate', 'D/L-3-hydroxybutyrate']","['palmitate rate of appearance', 'endogenous glucose production', 'D/L-3-hydroxybutyrate concentrations', 'free fatty acid concentrations, lowers lipolysis and endogenous glucose production, and dephosphorylates hormone-sensitive lipase', 'free fatty acid concentrations', 'adipose tissue biopsies']","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0604267', 'cui_str': 'L-3'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}]","[{'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0604267', 'cui_str': 'L-3'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0008385', 'cui_str': 'Cholesterol esterase'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",6.0,0.0523582,"Compared to the control, endogenous glucose production was reduced by close to 20% (P<0.05) after 3-hydroxybutyrate ingestion.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Svart', 'Affiliation': 'Departments of Endocrinology and Internal Medicine, Aarhus, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rittig', 'Affiliation': 'Departments of Endocrinology and Internal Medicine, Aarhus, Denmark.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Departments of Endocrinology and Internal Medicine, Aarhus, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Departments of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Departments of Endocrinology and Internal Medicine, Aarhus, Denmark.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14385']
1705,32790788,"RE-PERG in early-onset Alzheimer's disease: A double-blind, electrophysiological pilot study.","PURPOSE


To evaluate the ability of re-test pattern electroretinogram (RE-PERG), a non-invasive and fast steady-state PERG, to detect inner retinal bioelectric function anomalies in patients with early-onset Alzheimer's disease (AD).
METHODS


The study population consisted of 17 patients with AD-related mild cognitive impairment (MCI), 16 patients with vascular dementia (VD)-related MCI, both assessed using the neuropsychological Mini-Mental State Examination (MMSE) and by structural magnetic resonance imaging, and 19 healthy, age-matched normal controls (NC). All participants were visually asymptomatic, had normal or near-normal general cognitive functioning and no or minimal impairments in daily life activities. Visual field (VF) test, optical coherence tomography (OCT) and RE-PERG, sampled in five consecutive blocks of 130 events, were performed.
RESULTS


There was no statistically significant difference among the three groups with respect to age, VF parameters (mean and pattern standard deviations) and OCT parameters (ganglion cell complex thickness and retinal nerve fiber layer thickness). The mean amplitude in the RE-PERG was significantly lower, but only weakly in the AD group than in NC (p = 0.1) whereas the intrinsic variability of the 2nd harmonic phase was significantly higher in the AD group than in either the VD or NC group (p<0.001).
CONCLUSIONS


RE-PERG is altered in early-stage AD, showing a reduced amplitude with high intrinsic phase variability. It also allows the discrimination of AD from VD. A high intrinsic variability in the PERG signal, determined using RE-PERG, may thus be a new promising test for neurodegenerative diseases.",2020,"The mean amplitude in the RE-PERG was significantly lower, but only weakly in the AD group than in NC (p = 0.1) whereas the intrinsic variability of the 2nd harmonic phase was significantly higher in the AD group than in either the VD or NC group (p<0.001).
","['All participants were visually asymptomatic, had normal or near-normal general cognitive functioning and no or minimal impairments in daily life activities', '17 patients with AD-related mild cognitive impairment (MCI), 16 patients with vascular dementia (VD)-related MCI, both assessed using the neuropsychological Mini-Mental State Examination (MMSE) and by structural magnetic resonance imaging, and 19 healthy, age-matched normal controls (NC', 'five consecutive blocks of 130 events, were performed', ""patients with early-onset Alzheimer's disease (AD"", ""early-onset Alzheimer's disease""]","['RE-PERG', 're-test pattern electroretinogram (RE-PERG']","['Visual field (VF) test, optical coherence tomography (OCT) and RE-PERG', 'OCT parameters (ganglion cell complex thickness and retinal nerve fiber layer thickness', 'mean amplitude in the RE-PERG', 'intrinsic variability of the 2nd harmonic phase']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0011269', 'cui_str': 'Vascular dementia'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0750901', 'cui_str': 'Primary degenerative dementia of the Alzheimer type, presenile onset'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}]","[{'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035316', 'cui_str': 'Retinal Ganglion Cells'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",17.0,0.0540823,"The mean amplitude in the RE-PERG was significantly lower, but only weakly in the AD group than in NC (p = 0.1) whereas the intrinsic variability of the 2nd harmonic phase was significantly higher in the AD group than in either the VD or NC group (p<0.001).
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Mavilio', 'Affiliation': 'Social Health District, Glaucoma Center, Azienda Sanitaria Locale-Brindisi, Brindisi, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Sisto', 'Affiliation': 'Department of Neurosciences, Institute of Ophthalmology, University of Bari, Bari, Italy.'}, {'ForeName': 'Florenza', 'Initials': 'F', 'LastName': 'Prete', 'Affiliation': 'Social Health District, Alzheimer Evaluation Units, Azienda Sanitaria Locale-Brindisi, Brindisi, Italy.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Guadalupi', 'Affiliation': 'Social Health District, Alzheimer Evaluation Units, Azienda Sanitaria Locale-Brindisi, Brindisi, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Dammacco', 'Affiliation': 'Department of Neurosciences, Institute of Ophthalmology, University of Bari, Bari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Alessio', 'Affiliation': 'Department of Neurosciences, Institute of Ophthalmology, University of Bari, Bari, Italy.'}]",PloS one,['10.1371/journal.pone.0236568']
1706,32790792,Caffeine increases motor output entropy and performance in 4 km cycling time trial.,"Caffeine improves cycling time trial performance through enhanced motor output and muscle recruitment. However, it is unknown if caffeine further increases power output entropy. To investigate the effects of caffeine effects on cycling time trial performance and motor output entropy (MOEn), nine cyclists (VO2MAX of 55 ± 6.1 mL.kg.-1min-1) performed a 4 km cycling time trial (TT4km) after caffeine and placebo ingestion in a counterbalanced order. Power output data were sampled at a 2 Hz frequency, thereafter entropy was estimated on a sliding-window fashion to generate a power output time series. A number of mixed models compared performance and motor output entropy between caffeine and placebo every 25% of the total TT4km distance. Caffeine ingestion improved power output by 8% (p = 0.003) and increased MOEn by 7% (p = 0.018). Cyclists adopted a U-shaped pacing strategy after caffeine ingestion. MOEn mirrored power output responses as an inverted U-shape MOEn during the time trial. Accordingly, a strong inverse correlation was observed between MOEn and power output responses over the last 25% of the TT4km (p < 0.001), regardless of the ingestion, likely reflecting the end spurt during this period (p = 0.016). Caffeine ingestion improved TT4km performance and motor output responses likely due to a greater power output entropy.",2020,Caffeine ingestion improved power output by 8% (p = 0.003) and increased MOEn by 7% (p = 0.018).,['nine cyclists (VO2MAX of 55 ± 6.1 mL.kg.-1min-1'],"['caffeine and placebo', 'caffeine', 'Caffeine', 'caffeine and placebo ingestion', 'Caffeine ingestion']","['TT4km performance and motor output responses', 'cycling time trial performance and motor output entropy (MOEn', 'MOEn', 'MOEn and power output responses', 'power output']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0445194', 'cui_str': 'Power output'}]",,0.256056,Caffeine ingestion improved power output by 8% (p = 0.003) and increased MOEn by 7% (p = 0.018).,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Ferreira Viana', 'Affiliation': 'Physical Education course, Augusto Motta University Center (UNISUAM), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Trajano', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Kelvin Grove, QLD, Australia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ugrinowitsch', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, SP, Brazil.'}, {'ForeName': 'Flávio', 'Initials': 'F', 'LastName': 'Oliveira Pires', 'Affiliation': 'Exercise Psychophysiology Research Group, School of Arts, Sciences and Humanities, University of São Paulo, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0236592']
1707,32799042,Continuous positive airway pressure effectively ameliorates arrhythmias in patients with obstructive sleep apnea-hypopnea via counteracting the inflammation.,"INTRODUCTION


This work is aimed at evaluating the therapeutic effect of continuous positive airway pressure (CPAP) in treatment of patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) combined with arrhythmias as well as clarifying the possible mechanism underpinning such an intervention.
METHODS


Through exclusions, a total of 108 OSAHS patients combined with arrhythmias were enrolled from June 2017 to June 2019 with full clinical information in this work. A computerized permuted block design with varying block stratification and size according to age, sex, AHI and type of arrhythmia was used to randomize 108 patients to CPAP versus sham CPAP for a period of 12-week. All were subjected to unchanged pharmacological anti-arrhythmia therapy combined with CPAP. Before and after CPAP treatment, the improvement of various arrhythmias was compared between the CPAP group and the sham-CPAP group. The levels of CRP, IL-6 and TNF-ɑ were measured simultaneously.
RESULTS


During follow-up, the mean (±SD) CPAP pressure used in the CPAP group was 12.3 (±3.1) cm H2O. The use of CPAP and sham CPAP was on average of 5.2 ± 0.56 and 5.1 ± 0.63 h/night, respectively. After 12 weeks of CPAP therapy, the AHI was significantly decreased and the lowest blood oxygen saturation was notably elevated in the CPAP group compared to the sham-CPAP group, P < 0.05. The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS. The level of the c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) was significantly lower in the CPAP group than in the sham-CPAP group (P < 0.05). Pearson correlation analysis showed that the reduction in the incidence of total arrhythmias was positively correlated with the decrease of CRP, IL-6 and TNF-ɑ levels, respectively.
CONCLUSION


Findings from this work suggest that proper use of CPAP significantly benefits to OSAHS patients combined with arrhythmias, possibly via counteracting the inflammation.",2020,"The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS.","['patients with obstructive sleep apnea-hypopnea via counteracting the inflammation', '108 OSAHS patients combined with arrhythmias were enrolled from June 2017 to June 2019 with full clinical information in this work', 'patients with obstructive sleep apnea-hypopnea syndrome (OSAHS', 'patients with OSAHS']","['CPAP versus sham CPAP', 'CPAP', 'continuous positive airway pressure (CPAP', 'pharmacological anti-arrhythmia therapy combined with CPAP', 'Continuous positive airway pressure', 'CPAP and sham CPAP']","['mean (±SD) CPAP pressure', 'incidence of total arrhythmias', 'lowest blood oxygen saturation', 'improvement of various arrhythmias', 'CRP, IL-6 and TNF-ɑ levels', 'level of the c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α', 'incidence of all types of arrhythmia', 'levels of CRP, IL-6 and TNF-ɑ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",108.0,0.024615,"The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS.","[{'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Fumin', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Minglu', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, 250021, PR China. Electronic address: zg000507@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102655']
1708,32799180,The effect of small versus large clog size on emergency response time: A randomized controlled trial.,"OBJECTIVES


To assess the effect on healthcare professional emergency response time and safety of small compared to large clog size.
DESIGN


Randomized controlled trial.
SETTING


The intensive care unit of a single university medical centre in The Netherlands.
PARTICIPANTS


Intensive care medicine professionals.
INTERVENTIONS


Participants were randomized to wear European size 38 clogs (US male size 6½, US female size 7½) or European size 47 clogs (US male size 13½, US female size 14½) clogs and were required to run a 125 m course from the coffee break room to the elevator providing access to the emergency department.
MAIN OUTCOME MEASURES


The primary outcome was the time to complete the running course. Height, shoe size, self-described fitness, age and staff category were investigated as possible effect modifiers. Secondary endpoints were reported clog comfort and suspected unexpected clog-related adverse events (SUCRAEs).
RESULTS


50 participants were randomized (25 to European size 38 clogs and 25 to size 47 clogs). Mean age was 37 years (SD 12) and 29 participants (58%) were female. The primary outcome was 4.4 s (95% CI -7.1; -1.6) faster in the size 5 clogs group compared to the size 12 clogs group. This effect was not modified by any of the predefined participant characteristics. No differences were found in reported clog comfort or SUCRAEs.
CONCLUSIONS


European size 38 clogs lead to faster emergency response times than size 47 clogs.
TRIAL REGISTRATION


NCT04406220.",2020,"No differences were found in reported clog comfort or SUCRAEs.
","['Intensive care medicine professionals', 'The intensive care unit of a single university medical centre in The Netherlands', 'Participants were randomized to wear European size 38 clogs (US male size 6½, US female size 7½) or European size 47 clogs (US male size 13½, US female size 14½) clogs and were required to run a 125\xa0m course from the coffee break room to the elevator providing access to the emergency department', 'Mean age was 37\xa0years (SD 12) and 29 participants (58%) were female', '50 participants']",[],"['clog comfort and suspected unexpected clog-related adverse events (SUCRAEs', 'time to complete the running course', 'emergency response time', 'Height, shoe size, self-described fitness, age and staff category']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0013890', 'cui_str': 'Elevator'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0426931', 'cui_str': 'Shoe size'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]",50.0,0.195819,"No differences were found in reported clog comfort or SUCRAEs.
","[{'ForeName': 'Paul W G', 'Initials': 'PWG', 'LastName': 'Elbers', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands. Electronic address: p.elbers@amsterdamumc.nl.'}, {'ForeName': 'Harm-Jan', 'Initials': 'HJ', 'LastName': 'de Grooth', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Armand R J', 'Initials': 'ARJ', 'LastName': 'Girbes', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands.'}]",Journal of critical care,['10.1016/j.jcrc.2020.07.028']
1709,32810147,"An intimate partner violence prevention intervention for men, women, and couples in Ethiopia: Additional findings on substance use and depressive symptoms from a cluster-randomized controlled trial.","BACKGROUND


Intimate partner violence (IPV) is linked to substance use by male perpetrators and is associated with an increased risk of depression for women who experience violence. Unite for a Better Life (UBL) is a gender-transformative intervention delivered to men, women, and couples in Ethiopia; previous evidence demonstrated the intervention significantly reduced experience of and perpetration of IPV when delivered to men and led to more equitable household task-sharing when delivered to men and couples. The aim of this analysis is to assess engagement in the UBL intervention and to examine the relationship between random assignment to the intervention and men's past-year substance use and women's reported depressive symptoms as measured at the individual level.
METHODS AND FINDINGS


A sample of 64 villages in Gurague zone, Ethiopia, was randomly allocated to 4 arms (men's UBL, women's UBL, couples' UBL, or control). In each village, 106 households were randomly sampled, and households in the intervention arms were invited to participate in UBL, consisting of 14 sessions delivered by trained facilitators. Households in the control arm were offered a short educational session on IPV. Descriptive data on participant engagement in the intervention are reported, and outcomes assessed in an intention-to-treat (ITT) analysis include male use of substances (alcohol and khat) and women's depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9). Results from both adjusted and unadjusted specifications are reported, the latter adjusting for baseline covariates including age, education level, marriage length, polygamy, socioeconomic status, months between intervention and endline, and the baseline level of the outcome variable. The baseline sample includes 6,770 respondents surveyed in 2014-2015, and follow-up data were available from 88% of baseline respondents surveyed in 2017-2018; the majority of respondents report no education, and 61% are Muslim. Respondents reported high attendance rates and engagement in the intervention. In addition, there was evidence of a significant reduction in frequent past-year alcohol intoxication self-reported by men (adjusted odds ratio [AOR] = 0.56, 95% CI 0.36-0.85, p = 0.007), and a significant increase in the probability of frequent khat use self-reported by men (AOR = 3.09, 95% CI 1.37-6.96, p = 0.007), both observed in the couples' UBL arm at 24 months' follow-up relative to the control arm. There was a significant increase in symptoms of moderate depression among women in the women's UBL arm only (AOR = 1.65, 95% CI 1.13-2.41, p = 0.010), again relative to the control arm. There was no evidence of shifts in symptoms of mild or severe depression. The primary limitation of this study is the reliance on self-reported data around sensitive behaviors.
CONCLUSIONS


The findings suggest that the UBL intervention was associated with a reduction in men's use of alcohol when delivered to couples, but there was no evidence of a decrease in reported symptoms of depression among women in any experimental arm, and some evidence of an increase in symptoms of moderate depression in the women's UBL arm. Further research should explore how to optimize IPV prevention interventions to target related risks of mental health and substance use.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02311699; Socialscienceregistry.org AEARCTR-0000211.",2020,"The findings suggest that the UBL intervention was associated with a reduction in men's use of alcohol when delivered to couples, but there was no evidence of a decrease in reported symptoms of depression among women in any experimental arm, and some evidence of an increase in symptoms of moderate depression in the women's UBL arm.","['106 households were randomly sampled, and households in the intervention arms were invited to participate in', 'men, women, and couples in Ethiopia', 'A sample of 64 villages in Gurague zone, Ethiopia', '6,770 respondents surveyed in 2014-2015, and follow-up data were available from 88% of baseline respondents surveyed in 2017-2018; the majority of respondents report no education, and 61% are Muslim', 'women who experience violence', 'Intimate partner violence (IPV']","['intimate partner violence prevention intervention', 'short educational session on IPV', 'UBL, consisting of 14 sessions delivered by trained facilitators', 'UBL intervention']","['Patient Health Questionnaire (PHQ-9', 'symptoms of mild or severe depression', 'symptoms of moderate depression', 'symptoms of depression', 'probability of frequent khat use self', 'frequent past-year alcohol intoxication self', 'depressive symptoms']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0066582', 'cui_str': 'Catha edulis'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}]",106.0,0.141212,"The findings suggest that the UBL intervention was associated with a reduction in men's use of alcohol when delivered to couples, but there was no evidence of a decrease in reported symptoms of depression among women in any experimental arm, and some evidence of an increase in symptoms of moderate depression in the women's UBL arm.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Leight', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Negussie', 'Initials': 'N', 'LastName': 'Deyessa', 'Affiliation': 'Ethiopian Public Health Association, Addis Ababa, Ethiopia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Verani', 'Affiliation': 'CARE, New York, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Tewolde', 'Affiliation': 'EngenderHealth, Addis Ababa, Ethiopia.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003131']
1710,32812403,Mildly Elevated Cardiac Troponin below the 99th-Percentile Upper Reference Limit after Noncardiac Surgery.,"BACKGROUND AND OBJECTIVES


In patients with perioperative cardiac troponin (cTn) I below the 99th-percentile upper range of limit (URL), mortality according to cTn I level has not been fully evaluated. This study evaluated the association between postoperative cTn I level above the lowest limit of detection but within the 99th-percentile URL and 30-day mortality after noncardiac surgery.
METHODS


Patients with cTn I values below the 99th-percentile URL during the perioperative period were divided into a no-elevation group with cTn I at the lowest limit of detection (6 ng/L) and a minor elevation group with cTn I elevation below the 99th percentile URL (6 ng/L < cTn I < 40 ng/L). The primary outcome was 30-day mortality.
RESULTS


Of the 5,312 study participants, 2,582 (48.6%) were included in the no-elevation group and 2,730 (51.4%) were included in the minor elevation group. After propensity score-matching, the minor elevation group showed significantly increased 30-day mortality (0.5% vs. 2.3%; hazard ratio, 4.30; 95% confidence interval, 2.23-8.29; p<0.001). The estimated cutoff value of cTn I to predict 30-day mortality was 6 ng/L with the area under the receiver operating characteristic curve 0.657.
CONCLUSIONS


A mild elevation of cTn I within the 99th-percentile URL after noncardiac surgery was significantly associated with increased 30-day mortality as compared with the lowest limit of detection.
TRIAL REGISTRATION


Clinical Research Information Service Identifier: KCT0004244.",2020,"After propensity score-matching, the minor elevation group showed significantly increased 30-day mortality (0.5% vs. 2.3%; hazard ratio, 4.30; 95% confidence interval, 2.23-8.29; p<0.001).","['patients with perioperative cardiac troponin (cTn', 'Of the 5,312 study participants, 2,582 (48.6%) were included in the no-elevation group and 2,730 (51.4%) were included in the minor elevation group', 'Patients with cTn I values below the 99th-percentile URL during the perioperative period']",['no-elevation group with cTn'],"['30-day mortality', 'mild elevation of cTn', 'Mildly Elevated Cardiac Troponin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}]","[{'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0205250', 'cui_str': 'High'}]",5312.0,0.16335,"After propensity score-matching, the minor elevation group showed significantly increased 30-day mortality (0.5% vs. 2.3%; hazard ratio, 4.30; 95% confidence interval, 2.23-8.29; p<0.001).","[{'ForeName': 'Jungchan', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Cheol Won', 'Initials': 'CW', 'LastName': 'Hyeon', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Seung Hwa', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. shuaaa.lee@samsung.com.'}, {'ForeName': 'Jihoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Hye', 'Initials': 'JH', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kwangmo', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Center for Health Promotion, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Jin', 'Initials': 'JJ', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jong Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sangmin Maria', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Hoon', 'Initials': 'JH', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Bin', 'Initials': 'YB', 'LastName': 'Song', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo Yong', 'Initials': 'JY', 'LastName': 'Hahn', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Seung Hyuk', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyunga', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Joonghyun', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Hyeon Cheol', 'Initials': 'HC', 'LastName': 'Gwon', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Korean circulation journal,['10.4070/kcj.2020.0088']
1711,32814922,[Analysis of dispatcher-assisted cardiopulmonary resuscitation instructions to laypersons in an out-of-hospital cardiac arrest].,Randomized simulation trial to analyze dispatcher-assisted cardiopulmonary resuscitation instructions provided from the emergency call center in an out-of-hospital heart arrest assisted by lay persons. An analysis of the telephone instructions was performed using a 14-item checklist by two external researchers. Simulations lasted nine minutes. Twenty-one volunteers were enrolled. All of them started resuscitation maneuvers. Telephone instructions were verbalized in very heterogeneous ways. Half of the indicators exceeded 90% compliance. Frequently the recommendation of push hard and fast on the patient's chest was omitted and the dispatcher tended to mark a slower compression rate. The average time from the call to the start of the resuscitation was 3 min 33 s (SD: 1 min 7 s). The telephone instructions were verbalized in a very heterogeneous way. It is necessary to standardize and provide training in how to guide a dispatcher-assisted resuscitation.,2020,Randomized simulation trial to analyze dispatcher-assisted cardiopulmonary resuscitation instructions provided from the emergency call center in an out-of-hospital heart arrest assisted by lay persons.,"['Twenty-one volunteers were enrolled', 'emergency call center in an out-of-hospital heart arrest assisted by lay persons']",['dispatcher-assisted cardiopulmonary resuscitation instructions'],['average time'],"[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C4277665', 'cui_str': 'Call Center'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}]",21.0,0.0127399,Randomized simulation trial to analyze dispatcher-assisted cardiopulmonary resuscitation instructions provided from the emergency call center in an out-of-hospital heart arrest assisted by lay persons.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ballesteros-Peña', 'Affiliation': 'Organización Sanitaria Integrada Bilbao-Basurto. Bilbao.. sendoa.ballesteros@ehu.eus.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Fernández-Aedo', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vallejo-De la Hoz', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Etayo-Sancho', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alonso-Pinillos', 'Affiliation': ''}]",Anales del sistema sanitario de Navarra,['10.23938/ASSN.0873']
1712,32815436,Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes compared with other oral antihyperglycemic agents and placebo.,"Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA), recently approved in the USA and other countries. This paper reviews data from clinical trials (PIONEER 1, 2, 3, and 7) comparing oral semaglutide (once-daily doses of 3, 7, or 14 mg) with either once-daily placebo, empagliflozin 25 mg, or sitagliptin 100 mg. After 26 weeks in PIONEER 1, patients randomized to 3, 7, or 14 mg doses of oral semaglutide monotherapy had statistically significant reductions in glycated hemoglobin (HbA 1   c ) of 0.9%, 1.2%, and 1.4%, respectively, versus 0.3% with placebo. In the active-comparator studies, oral semaglutide 14 mg provided better glycemic control than empagliflozin or sitagliptin after 26 weeks, with durable effects. Body weight reductions were significantly greater with oral semaglutide than with placebo and sitagliptin. However, body weight reductions with oral semaglutide 14 mg versus empagliflozin 25 mg were not significantly different. Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time. Across these trials, 5-13% and 15-20% of patients experienced nausea with oral semaglutide 7 and 14 mg, respectively, and 2.3-3.4% and 5.1-8.0%, respectively, discontinued treatment due to gastrointestinal AEs. Severe or blood glucose-confirmed symptomatic hypoglycemia occurred infrequently with oral semaglutide and was seen most often in patients taking concomitant sulfonylureas. Findings from these trials indicate that the addition of oral semaglutide reduces HbA 1   c  and body weight and is associated with a low risk of hypoglycemia. Oral semaglutide represents an additional option for treating people with type 2 diabetes in primary care, with the potential to expand the numbers of patients benefiting from GLP-1RAs beyond that currently seen with injectable formulations.",2020,"Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time.",['patients with type 2 diabetes'],"['Oral semaglutide', 'oral semaglutide monotherapy', 'empagliflozin', 'oral antihyperglycemic agents and placebo', 'placebo, empagliflozin 25 mg, or sitagliptin 100 mg', 'oral semaglutide', 'placebo']","['HbA 1c  and body weight', 'Body weight reductions', 'glycated hemoglobin (HbA 1c ', 'Severe or blood glucose-confirmed symptomatic hypoglycemia', 'body weight reductions', 'nausea', 'Gastrointestinal adverse events (AEs) with oral semaglutide']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]",,0.127093,"Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lavernia', 'Affiliation': 'North Broward Diabetes Center , Pompano Beach, FL, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Department of Endocrinology, Ochsner Medical Center , New Orleans, LA, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1798638']
1713,32815439,"Oral semaglutide in patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients.","Patients with type 2 diabetes (T2D) often have comorbidities, such as cardiovascular disease or chronic kidney disease, and a large and growing proportion of the T2D patient population is over 65 years. There are many therapies for the treatment of T2D but not all are suitable for patients with comorbidities. Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA) and was recently approved for the treatment of T2D, representing an oral alternative to injectable GLP-1RAs. This article reviews data from: PIONEER 6, a phase 3a cardiovascular outcomes trial in patients at high cardiovascular risk; PIONEER 5, a phase 3a trial in patients with moderate renal impairment; a post-hoc analysis of PIONEER data by age; and pharmacokinetic trials investigating the effects of renal impairment, gastrointestinal disease, and hepatic impairment on the exposure of oral semaglutide. PIONEER 6 demonstrated the cardiovascular safety of oral semaglutide compared with placebo (hazard ratio: 0.79; 95% confidence interval [CI]: 0.57, 1.11; p < 0.001 for noninferiority), ruling out excess cardiovascular risk. In PIONEER 5, oral semaglutide was superior to placebo in decreasing glycated hemoglobin over 26 weeks (estimated treatment difference [ETD]: -0.8%; 95% CI: -1.0, -0.6; p < 0.0001) and body weight (ETD: -2.5 kg; 95% CI: -3.2, -1.8; p < 0.0001), and renal function was unchanged in both treatment groups. There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide. Across the trials, the safety profile of oral semaglutide was as expected for a GLP-1RA, with gastrointestinal adverse events most commonly reported. As such, oral semaglutide provides an effective oral GLP-1RA treatment option in older patients and/or those with comorbidities, with no requirements for dose adjustment.",2020,There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide.,"['older patients and/or those with comorbidities', 'patients with comorbidities', 'patients at high cardiovascular risk', 'Patients with type 2 diabetes (T2D) often have comorbidities, such as cardiovascular disease or chronic kidney disease, and a large and growing proportion of the T2D patient population is over 65 years', 'patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients', 'patients with moderate renal impairment']","['Oral semaglutide', 'ETD', 'placebo']","['renal function', 'body weight', 'glycated hemoglobin', 'cardiovascular safety of oral semaglutide', 'safety profile of oral semaglutide', 'glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}]",,0.0838752,There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide.,"[{'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Faculty of Medicine, Hebrew University of Jerusalem , Jerusalem, Israel.'}, {'ForeName': 'Eden M', 'Initials': 'EM', 'LastName': 'Miller', 'Affiliation': 'Diabetes Nation , Bend, OR, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Warren', 'Affiliation': 'Physicians East , Greenville, NC, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1800286']
1714,32822362,"Evaluation of seasonal malaria chemoprevention in two areas of intense seasonal malaria transmission: Secondary analysis of a household-randomised, placebo-controlled trial in Houndé District, Burkina Faso and Bougouni District, Mali.","BACKGROUND


Seasonal malaria chemoprevention (SMC) is now widely deployed in the Sahel, including several countries that are major contributors to the global burden of malaria. Consequently, it is important to understand whether SMC continues to provide a high level of protection and how SMC might be improved. SMC was evaluated using data from a large, household-randomised trial in Houndé, Burkina Faso and Bougouni, Mali.
METHODS AND FINDINGS


The parent trial evaluated monthly SMC plus either azithromycin (AZ) or placebo, administered as directly observed therapy 4 times per year between August and November (2014-2016). In July 2014, 19,578 children aged 3-59 months were randomised by household to study group. Children who remained within the age range 3-59 months in August each year, plus children born into study households or who moved into the study area, received study drugs in 2015 and 2016. These analyses focus on the approximately 10,000 children (5,000 per country) under observation each year in the SMC plus placebo group. Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August. The incidence rate ratio comparing SMC within the past 28 days with SMC more than 35 days ago-adjusted for age, country, and household clustering-was 0.13 (95% CI: 0.08, 0.20), P < 0.001 for malaria hospitalisations and deaths from malaria and 0.21 (95% CI 0.20, 0.23), P < 0.001 for uncomplicated malaria, indicating protective efficacy of 87.4% (95% CI: 79.6%, 92.2%) and 78.3% (95% CI: 76.8%, 79.6%), respectively. The prevalence of malaria parasitaemia at weekly surveys during the rainy season and at the end of the transmission season was several times higher in children who missed the SMC course preceding the survey contact, and the smallest prevalence ratio observed was 2.98 (95% CI: 1.95, 4.54), P < 0.001. The frequency of molecular markers of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance did not increase markedly over the study period either amongst study children or amongst school-age children resident in the study areas. After 3 years of SMC deployment, the day 28 PCR-unadjusted adequate clinical and parasitological response rate of the SP + AQ regimen in children with asymptomatic malaria was 98.3% (95% CI: 88.6%, 99.8%) in Burkina Faso and 96.1% (95% CI: 91.5%, 98.2%) in Mali. Key limitations of this study are the potential overdiagnosis of uncomplicated malaria by rapid diagnostic tests and the potential for residual confounding from factors related to adherence to the monthly SMC schedule.
CONCLUSION


Despite strong evidence that SMC is providing a high level of protection, the burden of malaria remains substantial in the 2 study areas. These results emphasise the need for continuing support of SMC programmes. A fifth monthly SMC course is needed to adequately cover the whole transmission season in the study areas and in settings with similar epidemiology.
TRIAL REGISTRATION


The AZ-SMC trial in which these data were collected was registered at clinicaltrials.gov: NCT02211729.",2020,"Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August.","['In July 2014, 19,578 children aged 3-59 months', 'Houndé District, Burkina Faso and Bougouni District, Mali', 'approximately 10,000 children (5,000 per country) under observation each year in the SMC plus placebo group', 'Children who remained within the age range 3-59 months in August each year, plus children born into study households or who moved into the study area, received study drugs in 2015 and 2016', 'study children or amongst school-age children resident in the study areas']","['seasonal malaria chemoprevention', 'azithromycin (AZ) or placebo', 'sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance', 'SP + AQ', 'placebo']","['prevalence of malaria parasitaemia', 'parasitological response rate', 'incidence rate ratio comparing SMC', 'smallest prevalence ratio', 'protective efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",19578.0,0.276926,"Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August.","[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Cairns', 'Affiliation': 'Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Ismaila', 'Initials': 'I', 'LastName': 'Thera', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Nikiema', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Serge R', 'Initials': 'SR', 'LastName': 'Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Barry', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Tapily', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Milligan', 'Affiliation': 'Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Jean Bosco', 'Initials': 'JB', 'LastName': 'Ouédraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Djimde', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}]",PLoS medicine,['10.1371/journal.pmed.1003214']
1715,32827645,Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low-to Middle-Income Countries: A Phase II Noninferiority Randomized Controlled Study.,"BACKGROUND


Minimal access surgery is not available to most people in rural areas of low-to middle-income countries. This leads to an increase in morbidity and economic loss to the poor and marginalized. Gasless laparoscopic (GAL) procedures are possible in rural areas because they can be performed under spinal anesthesia. In most cases, it does not require the logistics of providing gases for pneumoperitoneum and general anesthesia. The current study compares GAL with conventional laparoscopic (COL) operations for general surgical procedures.
METHODS


A single-center, nonblinded randomized controlled trial was conducted to evaluate noninferiority of GAL vs COL at a teaching hospital in New Delhi, India. Patients were allocated into 3 groups and underwent minimal access surgery (cholecystectomies and appendectomies). The procedures were performed by 2 surgeons choosing randomly between GAL and COL. The data were collected by postgraduates and analyzed by a biostatistician.
RESULTS


One hundred patients who met the inclusion criteria were allocated into 2 groups. No significant difference was observed in the mean operating time between the GAL group (52.9 minutes) and the COL group (55 minutes) (p = 0.3). Intraoperative vital signs were better in the GAL group (p < 0.05). The postoperative pain score was slightly higher in the GAL group (p = 0.01); however, it did not require additional analgesics.
CONCLUSIONS


No significant differences were found between the 2 groups. GAL can be considered as noninferior compared with COL and has the potential to be adopted in low-resource settings.",2020,The intraoperative vital signs were better in the GAL group [p < 0.05].,['100 patients who met the inclusion criteria'],"['GAL versus COL', 'MAS (Cholecystectomies and appendectomies', 'Gasless Laparoscopy', 'RCT', 'Gasless laparoscopic surgeries [GAL', 'Minimal access surgery [MAS', 'GAL', 'conventional Laparoscopic surgeries [COL']","['postoperative pain score', 'mean operating time', 'intraoperative vital signs']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0060993', 'cui_str': 'Galanin'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",100.0,0.035368,The intraoperative vital signs were better in the GAL group [p < 0.05].,"[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India. Electronic address: anurag.alok@gmail.com.'}, {'ForeName': 'Lovenish', 'Initials': 'L', 'LastName': 'Bains', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Gnanaraj', 'Initials': 'G', 'LastName': 'Jesudin', 'Affiliation': 'Project GILLS Association of Rural Surgeons of India, Dimapur, Nagaland, India.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Aruparayil', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Rajdeep', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Shashi', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi, India.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.07.783']
1716,32827709,Acute effect of inspiratory resistive loading on sprint interval exercise performance in team-sport athletes.,"This study examined acute effects of inspiratory resistive loading (IRL) during rest intervals on sprint interval exercise (SIE) performance. In a randomized crossover design, nine collegiate basketball players performed IRL (15 cmH 2 O) or passive recovery (CON) at 5-min rest intervals during and immediately after 6 sets of a 30-s SIE test. Performance, muscular oxygenation of vastus lateralis, blood lactate and pH were measured at each condition. Blood lactate at 5-min (-20.5 %) and 20-min (-21.3 %) after SIE were significantly lower in IRL than in CON. The pH at 5-min after SIE was significantly higher in IRL than in CON (+0.8 %, p <  0.05). However, the total work in IRL was significantly lower than in CON (-2.7 %, p <  0.05). Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5 %, p <  0.05). The IRL could attenuate exercise-induced metabolic acidosis; however, the decreased blood flow at rest intervals might increase the physical challenge in SIE.",2020,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p <  0.05).",['team-sport athletes'],"['inspiratory resistive loading (IRL', 'CON', 'inspiratory resistive loading', 'IRL (15\u2009cmH 2 O) or passive recovery (CON']","['sprint interval exercise performance', 'Blood lactate', 'IRL', 'sprint interval exercise (SIE) performance', 'total hemoglobin at rest intervals in IRL', 'blood flow', 'Performance, muscular oxygenation of vastus lateralis, blood lactate and pH', 'total work in IRL']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0557351', 'cui_str': 'Employed'}]",,0.0174742,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p <  0.05).","[{'ForeName': 'Ching-Feng', 'Initials': 'CF', 'LastName': 'Cheng', 'Affiliation': 'Department of Athletic Performance, National Taiwan Normal University, Taipei, Taiwan; Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan. Electronic address: andescheng@ntnu.edu.tw.'}, {'ForeName': 'Wei-Chieh', 'Initials': 'WC', 'LastName': 'Hsu', 'Affiliation': 'Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan; Graduate Institute of Sports Training, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Yu-Hsuan', 'Initials': 'YH', 'LastName': 'Kuo', 'Affiliation': 'Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan; Department of Physical Education, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Tzu-Wei', 'Initials': 'TW', 'LastName': 'Chen', 'Affiliation': 'Physical Education Office, National Chengchi University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Kuo', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103531']
1717,32836201,Development and validation of a nomogram for predicting survival of advanced breast cancer patients in China.,"BACKGROUND


There is a lack of prognostic models predicting the overall survival (OS) of advanced breast cancer (ABC) patients in China.
METHODS


Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC participants were enrolled in this study, which were further randomized 3:1 and divided into training (n = 1706) and validation (n = 557) groups. The nomogram was built based on independent predictors identified by univariate and multivariate cox regression analyses. The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
RESULTS


Univariate and multivariate analyses found that age, Eastern Cooperative Oncology Group (ECOG) score, T-stage, N-stage, tumor subtype, the presence of distant lymph node (DLN)/liver/brain metastasis, local therapy, efficacy of first-line therapy and metastatic-free interval (MFI) were significantly related to OS (all P < 0.05). These variables were incorporated into a nomogram to predict the 2-year and 3-year OS of ABC patients. The C-indexes of the nomogram were 0.700 (95% confidence interval [CI]: 0.683-0.717) for the training set and 0.686 (95% CI: 0.652-0.719) for the validation set. The calibration curves revealed satisfactory consistency between actual survival and nomogram prediction in both the internal and external validations. The nomogram was capable of stratifying patients into different risk cohorts.
CONCLUSIONS


We constructed and validated a nomogram that might serve as an efficient tool to provide prognostic prediction for ABC patients and guide the physicians to make personalized treatment decisions.",2020,"The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
","['advanced breast cancer patients in China', 'Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC participants', 'advanced breast cancer (ABC) patients in China']",[],['overall survival (OS'],"[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0456591', 'cui_str': '1987'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",4039.0,0.0279926,"The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
","[{'ForeName': 'Shaoyan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Hongnan', 'Initials': 'H', 'LastName': 'Mo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Zijing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Department of VIP Medical Services, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China. Electronic address: xubinghe@medmail.com.cn.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.004']
1718,32841748,Improvements in Quality of Life in Children Following Epicutaneous Immunotherapy (EPIT) for Peanut Allergy in the PEPITES and PEOPLE Studies.,"BACKGROUND


Food allergy quality of life (FAQL) is impaired in children with peanut allergy. Food Allergy Quality of Life Questionnaires (FAQLQs) provide disease-specific insight into the burden of peanut allergy and potential FAQL changes after peanut immunotherapy.
OBJECTIVE


To examine FAQL changes in children after treatment with epicutaneous immunotherapy for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg).
METHODS


FAQL was prospectively measured using the FAQLQ parent proxy form (Food Allergy Quality of Life Questionnaire-Parent Proxy Form [FAQLQ-PF], for children aged ≤12 years) and child form (Food Allergy Quality of Life Questionnaire-Child Form [FAQLQ-CF], child rated if aged ≥8 years) during the 12-month double-blind, randomized, controlled Peanut EPIT Efficacy and Safety Study (PEPITES) trial and the initial 12 months of the open-label PEPITES Open Label Extension Study (PEOPLE) follow-up study. Data were analyzed for between-group differences after treatment unblinding.
RESULTS


FAQLQs from placebo participants (FAQLQ-PF: 96; FAQLQ-CF: 47) and treatment group participants (FAQLQ-PF: 209; FAQLQ-CF: 105) were analyzed. Twenty-four-month global FAQL scores (FAQLQ-PF/FAQLQ-CF) were significantly improved in the treatment group versus the placebo group (least squares mean, 0.34, P = .008, and 0.46, P = .023, respectively). At 24 months, there was significant FAQLQ-PF score improvement in participants initially randomized to treatment who met the efficacy primary end point (n = 74; least squares mean, 0.55; P < .001) and in participants with any eliciting dose increase (n = 127; least squares mean, 0.66; P < .001). FAQLQ-PF improvements were observed in social dietary limitations (P = .002), food-related anxiety (P = .029), and emotional impact (P = .048) domains. FAQLQ-CF improvements were observed in risk of accidental exposure (P = .002) and allergen avoidance (P = .04) domains. Nearly all outcomes met a nontreatment context minimal clinically important difference previously cited for FAQLQ.
CONCLUSIONS


Epicutaneous immunotherapy treatment was observed to be associated with significant global and domain-specific FAQL improvement (FAQLQ-PF/FAQLQ-CF), largely driven by increases in eliciting dose, in children with peanut allergy.",2020,"PF improvements were observed in social dietary limitations (P=0.002), food-related anxiety (P=0.029), and emotional impact (P=0.048) domains.","['children with peanut allergy', '47) and treatment group participants (-PF: 209', 'children following treatment with', 'children aged ≤12 years) and child form (FAQLQ-CF, child rated if aged ≥8 years', 'participants']","['FAQLQ', 'CF', 'epicutaneous immunotherapy (EPIT', 'Epicutaneous Immunotherapy (EPIT', 'placebo']","['Food CAllergy Quality of Life Questionnaires (FAQLQs', 'allergen avoidance', 'significant global and domain-specific FAQL improvement (FAQLQ-PF/-CF', 'Quality of Life', 'emotional impact', 'global FAQL scores (FAQLQ-PF/CF', 'risk of accidental exposure', 'FAQLQ-PF score improvement', 'food-related anxiety', 'social dietary limitations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0450027', 'cui_str': 'Accidental exposure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",,0.357737,"PF improvements were observed in social dietary limitations (P=0.002), food-related anxiety (P=0.029), and emotional impact (P=0.048) domains.","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'DunnGalvin', 'Affiliation': 'School of Applied Psychology, University College Cork, Cork, Ireland; Paediatrics and Infectious Disease Department of Sechenov University, First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fleischer', 'Affiliation': ""Department of Pediatrics, Section of Allergy/Immunology, Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, Colo.""}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': ""Children's Hospital at Westmead, Sydney, NSW, Australia; DBV Technologies, Montrouge, France.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': ""O'B Hourihane"", 'Affiliation': 'Paediatrics and Child Health, University College Cork, Cork, Ireland; Paediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Green', 'Affiliation': ""DBV Technologies, Montrouge, France; UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pa.""}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Greenhawt', 'Affiliation': ""Department of Pediatrics, Section of Allergy/Immunology, Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, Colo. Electronic address: Matthew.Greenhawt@childrenscolorado.org.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.08.015']
1719,32841846,Decreased functional connectivity within the salience network after two-week morning bright light exposure in individuals with sleep disturbances: a preliminary randomized controlled trial.,"BACKGROUND


Bright light (BL) exposure is a safe non-pharmacological intervention for sleep disturbances. However, the functional brain correlates underlying the effects of bright light exposure need to be further clarified. As alterations in the salience network were reported in individuals with sleep disturbances, we have investigated whether bright light exposure may improve sleep quality by altering functional connectivity in this network.
METHODS


In the current study, 30 individuals with sleep disturbances were randomly assigned to one of the two interventions for two weeks: (1) 1 h of bright light (10,000 lux) exposure (BL-exposed group) and (2) 1 h of dim light (<300 lux) exposure (DL-exposed group). Sleep characteristics and functional connectivity in the salience network were assessed by sleep diary and resting-state functional magnetic resonance imaging, respectively, as outcome measures at before and after the intervention.
RESULTS


After two weeks of the intervention, the BL-exposed group showed greater improvement with respect to sleep efficiency (t = 2.27, p = 0.03) and sleep latency (t = -2.40, p = 0.03) as compared to the DL-exposed group. In addition, functional connectivity decreased in the cluster that encompasses the right anterior insular and the frontal opercular regions in the salience network (uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group. Decreased functional connectivity in the cluster was associated with decreased sleep latency in the BL-exposed group (β = 0.54, p = 0.01).
CONCLUSIONS


Our results suggest that bright light exposure may improve sleep quality in individuals with sleep disturbances by modulating functional connectivity in the salience network.
CLINICAL TRIAL REGISTRATION


https://cris.nih.go.kr/cris; KCT0002607.",2020,"(uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group.","['individuals with sleep disturbances', '30 individuals with sleep disturbances']","['bright light (10,000 lux) exposure (BL-exposed group) and', 'Bright light (BL) exposure', 'bright light exposure']","['sleep efficiency', 'functional connectivity', 'Decreased functional connectivity', 'sleep latency', 'sleep quality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",30.0,0.0552621,"(uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group.","[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Myeongju', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jungyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Gahae', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Namgung', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Shinwon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Soo Mee', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea; Department of Radiology, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'In Kyoon', 'Initials': 'IK', 'LastName': 'Lyoo', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea; Graduate School of Pharmaceutical Sciences, Ewha W. University, Seoul, South Korea; Department of Psychiatry, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Sujung', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea. Electronic address: sujungjyoon@ewha.ac.kr.'}]",Sleep medicine,['10.1016/j.sleep.2020.05.009']
1720,32798787,"Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction: A double-blinded, randomized, and placebo-controlled trial.","AIMS


To investigate the effect of the sodium-glucose co-transporter-2 inhibitor empagliflozin on N-terminal pro-b-type natriuretic peptide (NT-proBNP) in patients with heart failure (HF) and reduced ejection fraction (HFrEF).
METHODS AND RESULTS


Empire HF was an investigator-initiated, multi-center, double-blinded, placebo-controlled, randomized trial. Patients with mildly symptomatic HFrEF, mean (standard deviation (SD)) age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy were assigned to receive either empagliflozin 10 mg once daily or placebo for 12 weeks. The primary endpoint was the between-group difference in the change of NT-proBNP from baseline to 12 weeks. In total, 95 patients were assigned to empagliflozin and 95 to placebo. No significant difference in the change of NT-proBNP with empagliflozin versus placebo was observed [Empagliflozin: baseline, median (interquartile range (IQR)) 582 (304-1020) pg/mL, 12 weeks, 478 (281-961) pg/mL; Placebo: baseline, 605 (322-1070) pg/mL, 12 weeks, 520 (267-1075) pg/mL, adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7]. Further, no significant difference was observed in accelerometer-measured daily activity level [adjusted mean difference of change, empagliflozin versus placebo, -26.0 accelerometer counts; 95% CI -88.0 to 36.0, P = 0.4] or Kansas City Cardiomyopathy Questionnaire Overall Summary Score [adjusted mean difference of change, empagliflozin versus placebo 0.8; 95% CI -2.3 to 3.9, P = 0.6].
CONCLUSION


In low-risk patients with HFrEF with mild symptoms and on recommended HF therapy, empagliflozin did not change NT-proBNP after 12 weeks. Further, no change in daily activity level or health status was observed.",2020,"adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7].","['age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy', 'patients with heart failure (HF) and reduced ejection fraction (HFrEF', '582', 'Patients with mildly symptomatic HFrEF, mean (standard deviation (SD', 'patients with heart failure and reduced ejection fraction']","['Placebo', 'empagliflozin', 'sodium-glucose co-transporter-2 inhibitor empagliflozin', 'empagliflozin/placebo', 'HF therapy, empagliflozin', 'Empagliflozin', 'empagliflozin 10 mg once daily or placebo', 'placebo']","['daily activity level or health status', 'change of NT-proBNP', 'accelerometer-measured daily activity level', 'median (interquartile range (IQR', 'Kansas City Cardiomyopathy Questionnaire Overall Summary Score']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",95.0,0.793933,"adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7].","[{'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark. Electronic address: jesper.jensen.06@regionh.dk.'}, {'ForeName': 'Massar', 'Initials': 'M', 'LastName': 'Omar', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Mikael Kjær', 'Initials': 'MK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tuxen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg University Hospital, Bispebjerg Bakke 23, 2400 København NV, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg University Hospital, Bispebjerg Bakke 23, 2400 København NV, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Internal Medicine, Center of Endocrinology and Metabolism, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Emil L', 'Initials': 'EL', 'LastName': 'Fosbøl', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark.'}, {'ForeName': 'Niels Eske', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Sygehusvej 10, 4000 Roskilde, Denmark; Clinical Institute, Aalborg University, Søndre Skovvej 15, 9000 Aalborg, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Jan Christian', 'Initials': 'JC', 'LastName': 'Brønd', 'Affiliation': 'RICH/EXE, Department of Sport Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark.'}, {'ForeName': 'Julie Lyng', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Øster Farimagsgade 5, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark.'}, {'ForeName': 'Jacob Eifer', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}]",American heart journal,['10.1016/j.ahj.2020.07.011']
1721,32804621,Feasibility and Preliminary Efficacy of an Occupational Therapy Intervention for Older Adults With Chronic Conditions in a Primary Care Clinic.,"IMPORTANCE


Occupational therapy can play a role in primary care management of chronic diseases among older adults.
OBJECTIVE


To assess the feasibility of delivering a primary care occupation-focused intervention (Integrated PRimary care and Occupational therapy for Aging and Chronic disease Treatment to preserve Independence and Functioning, or i-PROACTIF) for older adults with chronic disease.
DESIGN


Feasibility study comparing i-PROACTIF with complex care management using a two-group randomized controlled trial design with data gathered at baseline and during and after the 8-wk intervention.
SETTING


Family medicine clinic serving an urban, low-income, working-class community.
OUTCOMES AND MEASURES


Feasibility indicators were recruitment, retention, utility of clinical assessments, and acceptability of interventions assessed through feedback surveys completed by patients and primary care providers (PCPs). Patient outcomes, including perspectives on chronic illness care, occupational performance, and overall well-being, were collected using standardized, validated measures and analyzed descriptively.
PARTICIPANTS


Eighteen adult volunteers, ages ≥50 yr, with heart disease, arthritis, and uncontrolled diabetes completed the study. Ten PCPs completed feedback surveys.
INTERVENTION


i-PROACTIF focuses on preserving functional independence, is based on the Person-Environment-Occupation framework, and consists of two assessment sessions and six weekly treatment sessions.
RESULTS


Recruitment goals were achieved, with an 86% retention rate. Clinical measures unearthed deficits in areas that were unreported or underreported by patients. Participants reported being extremely satisfied with the intervention. Physicians and nurses also supported the intervention. Both groups showed improved scores on most outcomes.
CONCLUSION AND RELEVANCE


Delivering and evaluating i-PROACTIF was feasible and acceptable. Future efficacy trials are needed before it can be used in clinical settings.
WHAT THIS ARTICLE ADDS


The results of this study can inform future occupational therapy interventions and clinical trials in primary care for older adults with chronic conditions.",2020,"Both groups showed improved scores on most outcomes.
","['older adults', 'older adults with chronic disease', 'Eighteen adult volunteers, ages ≥50 yr, with heart disease, arthritis, and uncontrolled diabetes completed the study', 'Older Adults With Chronic Conditions in a Primary Care Clinic', 'Family medicine clinic serving an urban, low-income, working-class community', 'older adults with chronic conditions']","['Occupational Therapy Intervention', 'primary care occupation-focused intervention (Integrated PRimary care and Occupational therapy']","['chronic illness care, occupational performance, and overall well-being', 'recruitment, retention, utility of clinical assessments, and acceptability of interventions assessed through feedback surveys completed by patients and primary care providers (PCPs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C3833703', 'cui_str': 'Family medicine clinic'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}]",18.0,0.0285227,"Both groups showed improved scores on most outcomes.
","[{'ForeName': 'Mansha', 'Initials': 'M', 'LastName': 'Mirza', 'Affiliation': 'Mansha Mirza, PhD, OTR/L, MSHSOR, is Associate Professor, Department of Occupational Therapy, University of Illinois at Chicago; mmirza2@uic.edu.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Gecht-Silver', 'Affiliation': 'Maureen Gecht-Silver, OTD, MPH, OTR/L, is Assistant Professor, Clinical Family Medicine and Clinical Occupational Therapy, and Associate Director, Medical Student Education, Department of Family Medicine, University of Illinois at Chicago.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Keating', 'Affiliation': 'Emily Keating, OTD, OTR/L, is Occupational Therapist, Chicago Public Schools, Chicago.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Krischer', 'Affiliation': 'Amy Krischer, OTD, OTR/L, is Occupational Therapist and Independent Early Intervention Contractor, Chicago.'}, {'ForeName': 'Hajwa', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Hajwa Kim, MS, is Associate Director, Biostatistics Core, Center for Clinical and Translational Science, University of Illinois at Chicago.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kottorp', 'Affiliation': 'Anders Kottorp, PhD, OT Reg, is Professor and Dean, Health and Society, University of Malmö, Malmö, Sweden.'}]",The American journal of occupational therapy : official publication of the American Occupational Therapy Association,['10.5014/ajot.2020.039842']
1722,32810383,"Phase III, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of teneligliptin monotherapy in Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.","AIMS/INTRODUCTION


Although the efficacy of teneligliptin, a highly selective dipeptidyl peptidase-4 inhibitor, has been amply studied for the treatment of type 2 diabetes, no clinical trials of teneligliptin have been carried out in China. We evaluated the efficacy and safety of teneligliptin monotherapy compared with a placebo in Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.
MATERIALS AND METHODS


This multicenter, randomized, double-blind, placebo-controlled, parallel-group study, carried out at 42 sites, enrolled type 2 diabetes patients with glycosylated hemoglobin 7.0 to <10.0% and fasting blood glucose <270 mg/dL. Patients were randomly assigned, in a 1:1 ratio, to treatment with 20 mg teneligliptin or a placebo (n = 127, each) administered orally once daily before breakfast for 24 weeks. Change in glycosylated hemoglobin from baseline to week 24 was the primary efficacy end-point. Safety was assessed by the incidence of adverse events and adverse drug reactions.
RESULTS


The least square mean (LSM) change in glycosylated hemoglobin from baseline to week 24 was -0.95% with teneligliptin versus -0.14% with a placebo, yielding an LSM difference (teneligliptin vs placebo) of -0.80% (P < 0.0001). For the secondary end-point, from baseline to week 24, the LSM change in fasting blood glucose was -21.9 mg/dL with teneligliptin versus -1.4 mg/dL with a placebo, yielding an LSM difference (teneligliptin vs placebo) of -20.5 mg/dL (P < 0.0001). The adverse event and adverse drug reaction incidence rates, including hypoglycemia, were similar in both groups.
CONCLUSIONS


At 24 weeks, teneligliptin was generally well tolerated and effective in Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.",2020,"The least square mean (LSM) change in HbA1c from baseline to Week 24 was -0.95% with teneligliptin vs -0.14% with placebo, yielding an LSM difference (teneligliptin vs placebo) of -0.80% (p<0.0001).","['Chinese T2DM patients with inadequately controlled with diet and exercise', '42 sites, enrolled type 2 diabetes patients with glycosylated hemoglobin', 'Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise']","['teneligliptin', 'teneligliptin or placebo', 'placebo', 'LSM difference (teneligliptin vs placebo', 'teneligliptin monotherapy']","['hypoglycaemia', 'HbA1c', 'fasting blood glucose (FPG', 'incidence of adverse events (AEs) and adverse drug reactions (ADRs', 'tolerated and effective', 'efficacy and safety', 'LSM change in FPG', 'least square mean (LSM) change in HbA1c']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.39855,"The least square mean (LSM) change in HbA1c from baseline to Week 24 was -0.95% with teneligliptin vs -0.14% with placebo, yielding an LSM difference (teneligliptin vs placebo) of -0.80% (p<0.0001).","[{'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Nanjing First Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Huai'an First People's Hospital, Huaian, Jiangsu, China.""}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Jiangxi Province People's Hospital, Nanchang, Jiangxi, China.""}, {'ForeName': ""Jiao'e"", 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Jingzhou Central Hospital, Jingzhou, Hubei, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Minhang Central Hospital, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Xiuzhen', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Tongji Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'The First Affiliated Hospital, University of South China, Hengyang, Hunan, China.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Takayanagi', 'Affiliation': 'Mitsubishi Tanabe Pharma Development America, Inc., Jersey City, New Jersey, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Mitsubishi Tanabe Pharma Development (Beijing) Co., Ltd., Beijing, China.'}]",Journal of diabetes investigation,['10.1111/jdi.13389']
1723,31484697,Peri-procedural stroke or death in stenting of symptomatic severe intracranial stenosis.,"BACKGROUND AND PURPOSE


There are limited data on predictors of 30-day stroke or death in patients with symptomatic intracranial atherosclerosis (sICAS) undergoing stenting. We aim to determine the factors associated with stroke or death at 30 days in the stenting arm of the SAMMPRIS trial.
METHODS


This is a post-hoc analysis of the SAMMPRIS trial including patients who underwent angioplasty/stenting. We compared patient-specific variables, lesion-specific variables, procedure-specific variables, and FDA-approved indications between patients with and without the primary outcome (stroke or death at 30 days). Logistic regression analyses were performed to evaluate associations with the primary outcome.
RESULTS


We identified 213 patients, 30 of whom (14.1%) met the primary outcome. Smoking status and lesion length were associated with the primary outcome: the odds of stroke or death for non-smokers versus smokers (adjusted OR 4.46, 95% CI 1.79 to 11.1, p=0.001) and for increasing lesion length in millimeters (adjusted OR 1.20, 95% CI 1.02 to 1.39, p=0.029). These had a modest predictive value: absence of smoking history (sensitivity 66.7%, specificity 65.4%) and lesion length (area under curve 0.606). Furthermore, event rates were not significantly different between patients with and without the FDA-approved indication for stenting (15.9% vs 12%, p=0.437).
CONCLUSION


In SAMMPRIS patients who underwent angioplasty/stenting, neither clinical and neuroimaging variables nor the FDA indication for stenting reliably predicted the primary outcome. Further work in identifying reliable biomarkers of stroke/death in patients with sICAS is needed before considering new clinical trials of stenting.
TRIAL REGISTRATION NUMBER


SAMMPRIS NCT00576693; Results.",2020,"These had a modest predictive value: absence of smoking history (sensitivity 66.7%, specificity 65.4%) and lesion length (area under curve 0.606).","['patients with symptomatic intracranial atherosclerosis (sICAS) undergoing stenting', 'patients who underwent angioplasty/stenting', 'symptomatic severe intracranial stenosis', 'patients with sICAS', '213 patients, 30 of whom (14.1%) met the primary outcome']",['angioplasty/stenting'],"['Smoking status and lesion length', 'odds of stroke or death', 'lesion length', 'event rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0751007', 'cui_str': 'Intracranial Atherosclerosis'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.408369,"These had a modest predictive value: absence of smoking history (sensitivity 66.7%, specificity 65.4%) and lesion length (area under curve 0.606).","[{'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yaghi', 'Affiliation': 'Department of Neurology, New York Langone Health, New York, NY, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Khatri', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Havenon', 'Affiliation': 'Department of Neurology, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Yeatts', 'Affiliation': 'Department of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'Cutting', 'Affiliation': 'Department of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mac Grory', 'Affiliation': 'Department of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Burton', 'Affiliation': 'Department of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Jayaraman', 'Affiliation': 'Department of Diagnostic Imaging, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'McTaggart', 'Affiliation': 'Department of Neurosurgery, Cleveland Clinic Florida, Weston, Florida, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fiorella', 'Affiliation': 'Department of Neurosurgery, Stony Brook University, Stony Brook, New York, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Derdeyn', 'Affiliation': 'Department of Radiology and Interventional Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.'}, {'ForeName': 'Osama O', 'Initials': 'OO', 'LastName': 'Zaidat', 'Affiliation': 'Department of Neuroscience, St Vincent Mercy Hospital, Toledo, Ohio, USA.'}, {'ForeName': 'Seena', 'Initials': 'S', 'LastName': 'Dehkharghani', 'Affiliation': 'NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Amin-Hanjani', 'Affiliation': 'Neurosurgery, University of Illinois, Chicago, Illinois, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Furie', 'Affiliation': 'Department of Neurology, Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Prahbakaran', 'Affiliation': 'Neurology, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liebeskind', 'Affiliation': 'Department of Neurology, UCLA, Los Angeles, California, USA.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015225']
1724,32813780,Learning musculoskeletal anatomy through new technologies: a randomized clinical trial.,"OBJECTIVE


to investigate the influence of the application of new methodologies on learning and the motivation of students of the Anatomy discipline.
METHOD


randomized, longitudinal, prospective, intervention study. Sixty-two students were recruited to assess the impact of different methodologies. The sample was randomized to compare the results of teaching with a 3D atlas, ultrasound and the traditional method. The parameters were assessed through a satisfaction evaluation questionnaire and anatomical charts. Repeated measures ANOVA was used to determine statistical significance.
RESULTS


in terms of the usefulness of the seminars, 98.1% of the students considered them to be very positive or positive, stating that they had stimulated their interest in anatomy. The students who learned with the 3D atlas improved their understanding of anatomy (p=0.040). In general, the students improved their grades by around 20%.
CONCLUSION


the traditional method combined with new technologies increases the interest of students in human anatomy and enables them to acquire skills and competencies during the learning process.",2020,The students who learned with the 3D atlas improved their understanding of anatomy (p=0.040).,['Sixty-two students'],[],[],"[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],[],62.0,0.0349984,The students who learned with the 3D atlas improved their understanding of anatomy (p=0.040).,"[{'ForeName': 'Elena Sonsoles', 'Initials': 'ES', 'LastName': 'Rodríguez-López', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Sofía Olivia', 'Initials': 'SO', 'LastName': 'Calvo-Moreno', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Eduardo Cimadevilla', 'Initials': 'EC', 'LastName': 'Fernández-Pola', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Fernández-Rodríguez', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Guodemar-Pérez', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Ruiz-López', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3237.3281']
1725,32814339,Effects of Vibration Training in Interstitial Lung Diseases: A Randomized Controlled Trial.,"BACKGROUND


Numerous studies have reported positive effects of exercise training in patients with interstitial lung disease (ILD) on physical capacity and quality of life. However, evidence is rare on the effects of specific forms of training and further pathophysiological mechanisms in these patients.
OBJECTIVES


In this multicenter study we aimed to explore the clinical effects of whole-body vibration training (WBVT) in patients with ILD on various outcome measures, including proinflammatory cytokines and myostatin.
METHODS


We randomly assigned 26 patients with different forms of multidisciplinary confirmed fibrotic ILDs either to the WBVT group (n = 11; 55% male, 61 ± 14 years old, forced vital capacity 83.2 ± 29.3% predicted, 6-min walking distance [6MWD] 478 ± 79 m) performing 3 months of a standardized training (3 times per week), or to a control training group (CTG, n = 15; 60% male, 63 ± 9 years old, FVC 74.6 ± 20.5% predicted, 6MWD 455 ± 85 m) performing sham WBV training. Training in the two groups was performed on a GalileoTM vibration plate (6-20 vs. 5 Hz). The functional assessments before and after the intervention period included pulmonary function, 6MWD test, chair rise test, ultrasonographic measurement of quadriceps muscle thickness (cross-sectional area), quality of life questionnaires, and serum samples.
RESULTS


We observed a significant increase in 6MWD (∆Training = 30 m [12-67], p = 0.024) and a decrease of myostatin (∆Training = -465 pg/mL [-713 to -166], p = 0.008) in the WBVT group. In contrast, no significant differences were observed in the CTG.
CONCLUSIONS


The present study demonstrates that WBVT is able to significantly increase 6MWD and decrease myostatin in patients with fibrotic ILDs. Therefore, WBVT seems to be a beneficial and feasible training modality in ILD patients. Clinical Trial Registry: German Clinical Trials Registry (DRKS00012930).",2020,"We observed a significant increase in 6MWD (∆Training = 30 m [12-67], p = 0.024) and a decrease of myostatin (∆Training = -465 pg/mL","['Interstitial Lung Diseases', 'ILD patients', '26 patients with different forms of multidisciplinary confirmed fibrotic ILDs either to the WBVT group (n = 11; 55% male, 61 ± 14 years old, forced vital capacity 83.2 ± 29.3% predicted, 6-min walking distance', 'patients with interstitial lung disease (ILD', 'patients with fibrotic ILDs', 'patients with ILD']","['WBVT', 'exercise training', 'control training', 'GalileoTM vibration plate', 'whole-body vibration training (WBVT', 'sham WBV training', 'Vibration Training']","['pulmonary function, 6MWD test, chair rise test, ultrasonographic measurement of quadriceps muscle thickness (cross-sectional area), quality of life questionnaires, and serum samples', 'proinflammatory cytokines and myostatin', '6MWD']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}]",26.0,0.0300793,"We observed a significant increase in 6MWD (∆Training = 30 m [12-67], p = 0.024) and a decrease of myostatin (∆Training = -465 pg/mL","[{'ForeName': 'Andreas Rembert', 'Initials': 'AR', 'LastName': 'Koczulla', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Boeselt', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Koelpin', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Kaufhold', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Veith', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nell', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Jarosch', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany, ijarosch@schoen-klinik.de.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Spielmanns', 'Affiliation': 'Pulmonology, Zuercher Reha Zentrum Wald, Wald, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Alter', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kähler', 'Affiliation': 'Pneumology SKB, Private Clinic Kettenbruecke, Innsbruck, Austria.'}, {'ForeName': 'Timm', 'Initials': 'T', 'LastName': 'Greulich', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Glöckl', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Schneeberger', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kenn', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Nicolas Carlos', 'Initials': 'NC', 'LastName': 'Kahn', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Felix J F', 'Initials': 'FJF', 'LastName': 'Herth', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}]",Respiration; international review of thoracic diseases,['10.1159/000508977']
1726,32818546,Consumers' reactions to nutrition and ingredient labelling for wine - A cross-country discrete choice experiment.,"The purpose of this study is to examine consumers' reactions to the introduction of nutrition and ingredient labelling for wine, a product that is so far still exempt from mandatory nutrition and ingredient labelling. It also analyses the effect of positive and negative information about the use of ingredients in wine on consumers' choice. Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n = 745; Germany, n = 716; Italy, n = 715) completed a discrete choice experiment (DCE) with graphically simulated wine back labels. For each country, respondents were randomly allocated to a reference group and two different treatment conditions where they received newspaper-like information (positive, negative) before making choices. Results for the reference condition show that consumers across all three countries have a significant positive utility for detailed nutrition information. Instead, ingredient information only receives a positive utility in Italy, whereas German and Australian respondents do not receive utility from ingredient labelling. When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine. The treatment effect of positive media information on consumers' wine choice is lower than that of negative information. The results of the study have implications for the pending new regulation of wine labelling and for communication strategies of the wine industry that should actively inform consumers about the necessity of ingredients in wine production.",2020,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","['Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n\u202f=\u202f745; Germany, n\u202f=\u202f716; Italy, n\u202f=\u202f715) completed a']",['discrete choice experiment (DCE) with graphically simulated wine back labels'],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0043188', 'cui_str': 'Wine'}]",[],745.0,0.025423,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Pabst', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany. Electronic address: Evelyn.Pabst@hs-gm.de.'}, {'ForeName': 'Armando Maria', 'Initials': 'AM', 'LastName': 'Corsi', 'Affiliation': 'Adelaide Business School, The University of Adelaide, SA, 5005, Australia. Electronic address: Armando.Corsi@adelaide.edu.au.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Vecchio', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Via Università, 100, 80055, Portici (Naples), Italy. Electronic address: riccardo.vecchio@unina.it.'}, {'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'Annunziata', 'Affiliation': 'Department of Economic and Legal Studies, University of Naples ""Parthenope"", Via G. Parisi, 13, 80133, Naples, Italy. Electronic address: azzurra.annunziata@uniparthenope.it.'}, {'ForeName': 'Simone Mueller', 'Initials': 'SM', 'LastName': 'Loose', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany; Ehrenberg-Bass Instiute for Marketing Science, University of South, North Terrace, Adelaide, SA, 5000, Australia. Electronic address: Simone.Loose@hs-gm.de.'}]",Appetite,['10.1016/j.appet.2020.104843']
1727,32818573,"Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.","ETHNOPHARMACOLOGICAL RELEVANCE


Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia.
MATERIAL AND METHODS


We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed.
RESULTS


In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group.
CONCLUSION


The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.",2020,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","['80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia', 'healthy subjects and also in the subjects having insomnia', 'healthy volunteers and insomnia patients']","['Ashwagandha root extract', 'ashwagandha root extract', 'Ashwagandha or placebo', 'placebo']","['parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality', 'sleep parameters', 'insomnia subjects', 'mental alertness', 'sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake', 'sleep efficiency', 'Safety and adverse events', 'sleep quality', 'SOL', 'Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0549164', 'cui_str': 'Mental alertness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",80.0,0.0352543,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Langade', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: deepak.langade@dypatil.edu.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Thakare', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: vaishali.thakare@dypatil.edu.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kanchi', 'Affiliation': 'NAMO Medical Education and Research Institute, Silvassa, DNH&DD, India. Electronic address: rksubodh@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kelgane', 'Affiliation': 'Maharashtra Emergency Medical Services, Defence Area, Pimple Gurav, Pimpri-Chinchwad, 411027, Maharashtra, India. Electronic address: sunildrkelgane@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113276']
1728,32819681,Five-Year Outcomes and Prognostic Value of Feature-Tracking Cardiovascular Magnetic Resonance in Patients Receiving Early Prereperfusion Metoprolol in Acute Myocardial Infarction.,"The aim of the present study was to investigate the long-term impact of early intravenous metoprolol in ST-segment elevation myocardial infarction (STEMI) patients in terms of left ventricular (LV) strain with feature-tracking cardiovascular magnetic resonance (CMR) and its association with prognosis. A total of 270 patients with first anterior STEMI enrolled in the randomized METOCARD-CNIC clinical trial, assigned to receive up to 15 mg intravenous metoprolol before primary percutaneous coronary intervention versus conventional STEMI therapy, were included. LV global circumferential (GCS) and longitudinal (GLS) strain were assessed with feature-tracking CMR at 1 week after STEMI in 215 patients. The occurrence of major adverse cardiac events (MACE) at 5-year follow-up was the primary end point. Among 270 patients enrolled, 17 of 139 patients assigned to metoprolol arm and 31 of 131 patients assigned to control arm experienced MACE (hazard ratio [HR] 0.500, 95% confidence interval [CI] 0.277 to 0.903; p = 0.022). Impaired LV GCS and GLS strain were significantly associated with increased occurrence of MACE (GCS: HR 1.208, 95% CI 1.076 to 1.356, p =0.001; GLS: HR 1.362, 95% CI 1.180 to 1.573, p < 0.001). On multivariable analysis, LV GLS provided incremental prognostic value over late gadolinium enhancement (LGE) and LV ejection fraction (LVEF) (LGE + LVEF chi-square = 12.865, LGE + LVEF + GLS chi-square = 18.459; p =0.012). Patients with GLS ≥-11.5% (above median value) who received early intravenous metoprolol were 64% less likely to experience MACE than their counterparts with same degree of GLS impairment (HR 0.356, 95% CI 0.129 to 0.979; p = 0.045). In conclusion, early intravenous metoprolol has a long-term beneficial prognostic effect, particularly in patients with severely impaired LV systolic function. LV GLS with feature-tracking CMR early after percutaneous coronary intervention offers incremental prognostic value over conventional CMR parameters in risk stratification of STEMI patients.",2020,"Impaired LV GCS and GLS strain were significantly associated with increased occurrence of MACE (GCS: HR 1.208, 95% CI 1.076 to 1.356, p =0.001; GLS: HR 1.362, 95% CI 1.180 to 1.573, p < 0.001).","['215 patients', 'STEMI patients', 'Patients Receiving Early Prereperfusion Metoprolol in Acute Myocardial Infarction', '270 patients enrolled, 17 of 139 patients assigned to', 'patients with severely impaired LV systolic function', '270 patients with first anterior STEMI enrolled']","['metoprolol before primary percutaneous coronary intervention versus conventional STEMI therapy', 'metoprolol']","['incremental prognostic value over late gadolinium enhancement (LGE) and LV ejection fraction (LVEF) (LGE\u202f+\u202fLVEF chi-square', 'GLS impairment', 'occurrence of major adverse cardiac events (MACE', 'LV global circumferential (GCS) and longitudinal (GLS) strain', 'Impaired LV GCS and GLS strain']","[{'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}]",270.0,0.0522323,"Impaired LV GCS and GLS strain were significantly associated with increased occurrence of MACE (GCS: HR 1.208, 95% CI 1.076 to 1.356, p =0.001; GLS: HR 1.362, 95% CI 1.180 to 1.573, p < 0.001).","[{'ForeName': 'Tomaž', 'Initials': 'T', 'LastName': 'Podlesnikar', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands; University Medical Centre Maribor, Maribor, Slovenia; Internal Medicine Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Pizarro', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; CIBER de enfermedades CardioVasculares (CIBERCV), Madrid, Spain; Ruber Juan Bravo Hospital Universidad Europea, Madrid, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Fernández-Jiménez', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; CIBER de enfermedades CardioVasculares (CIBERCV), Madrid, Spain; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Montero-Cabezas', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sánchez-González', 'Affiliation': 'Philips Healthcare, Madrid, Spain.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bucciarelli-Ducci', 'Affiliation': 'Bristol Heart Institute, Bristol NIHR Cardiovascular Research Centre, University of Bristol and University Hospitals Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Ajmone Marsan', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Zlatko', 'Initials': 'Z', 'LastName': 'Fras', 'Affiliation': 'Internal Medicine Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibáñez', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; CIBER de enfermedades CardioVasculares (CIBERCV), Madrid, Spain; IIS-Fundación Jiménez Díaz University Hospital, Madrid, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Delgado', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: v.delgado@lumc.nl.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.07.037']
1729,32776430,"Absorption, Pharmacokinetics, and Urinary Excretion of Pyridines After Consumption of Coffee and Cocoa-Based Products Containing Coffee in a Repeated Dose, Crossover Human Intervention Study.","SCOPE


The present study assesses the absorption, pharmacokinetics, and urinary excretion of coffee pyridines and their metabolites after daily regular exposure to specific dosages of coffee or cocoa-based products containing coffee (CBPCC), considering different patterns of consumption.
METHODS AND RESULTS


In a three-arm, crossover, randomized trial, 21 volunteers are requested to randomly consume for 1 month: one cup of espresso coffee per day, three cups of espresso coffee per day, or one cup of espresso coffee plus two CBPCC twice per day. The last day of the one-month treatment, blood and urine samples are collected for 24 h. Trigonelline, N-methylpyridinium, N-methylnicotinamide, and N-methyl-4-pyridone-5-carboxamide are quantified. Trigonelline and N-methylpyridinium absorption curves and 24-h urinary excretion reflect the daily consumption of different servings of coffee or CBPCC, showing also significant differences in main pharmacokinetic parameters. Moreover, inter-subject variability due to sex and smoking is assessed, showing sex-related differences in the metabolism of trigonelline and smoking-related ones for N-methylpyridinium.
CONCLUSION


The daily exposure to coffee pyridines after consumption of different coffee dosages in a real-life setting is established. This data will be useful for future studies aiming at evaluating the bioactivity of coffee-derived circulating metabolites in cell experiments, mimicking more realistic experimental conditions.",2020,"Trigonelline and N-methylpyridinium absorption curves and 24-h urinary excretion reflect the daily consumption of different servings of coffee or CBPCC, showing also significant differences in main pharmacokinetic parameters.",['21 volunteers are requested to randomly consume for 1 month: one'],"['Coffee and Cocoa-Based Products', 'cup of espresso coffee per day, three cups of espresso coffee per day, or one cup of espresso coffee plus two CBPCC', 'coffee or cocoa-based products containing coffee (CBPCC', 'Trigonelline']","['Absorption, Pharmacokinetics, and Urinary Excretion of Pyridines', 'absorption, pharmacokinetics, and urinary excretion of coffee pyridines and their metabolites']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0360301', 'cui_str': 'Product base'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0077132', 'cui_str': 'trigonelline'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0034251', 'cui_str': 'Pyridine'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",21.0,0.0279235,"Trigonelline and N-methylpyridinium absorption curves and 24-h urinary excretion reflect the daily consumption of different servings of coffee or CBPCC, showing also significant differences in main pharmacokinetic parameters.","[{'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Bresciani', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tassotti', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Rosi', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drug, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Martini', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Antonini', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Medicine and Surgery, University of Parma, Via Gramsci 14, Parma, 43126, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Dei Cas', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Medicine and Surgery, University of Parma, Via Gramsci 14, Parma, 43126, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bonadonna', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Medicine and Surgery, University of Parma, Via Gramsci 14, Parma, 43126, Italy.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Brighenti', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drug, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Del Rio', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Mena', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drug, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000489']
1730,32817632,Evaluation of the effectiveness of topical repellent distributed by village health volunteer networks against Plasmodium spp. infection in Myanmar: A stepped-wedge cluster randomised trial.,"BACKGROUND


The World Health Organization has yet to endorse deployment of topical repellents for malaria prevention as part of public health campaigns. We aimed to quantify the effectiveness of repellent distributed by the village health volunteer (VHV) network in the Greater Mekong Subregion (GMS) in reducing malaria in order to advance regional malaria elimination.
METHODS AND FINDINGS


Between April 2015 and June 2016, a 15-month stepped-wedge cluster randomised trial was conducted in 116 villages in Myanmar (stepped monthly in blocks) to test the effectiveness of 12% N,N-diethylbenzamide w/w cream distributed by VHVs, on Plasmodium spp. infection. The median age of participants was 18 years, approximately half were female, and the majority were either village residents (46%) or forest dwellers (40%). No adverse events were reported during the study. Generalised linear mixed modelling estimated the effect of repellent on infection detected by rapid diagnostic test (RDT) (primary outcome) and polymerase chain reaction (PCR) (secondary outcome). Overall Plasmodium infection detected by RDT was low (0.16%; 50/32,194), but infection detected by PCR was higher (3%; 419/13,157). There was no significant protection against RDT-detectable infection (adjusted odds ratio [AOR] = 0.25, 95% CI 0.004-15.2, p = 0.512). In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233). Repellent effects were similar when delayed effects were modelled, across risk groups, and regardless of village-level and temporal heterogeneity in malaria prevalence. The incremental cost-effectiveness ratio was US$256 per PCR-detectable infection averted. Study limitations were a lower than expected Plasmodium spp. infection rate and potential geographic dilution of the intervention.
CONCLUSIONS


In this study, we observed apparent protection against new infections associated with the large-scale distribution of repellent by VHVs. Incorporation of repellent into national strategies, particularly in areas where bed nets are less effective, may contribute to the interruption of malaria transmission. Further studies are warranted across different transmission settings and populations, from the GMS and beyond, to inform WHO public health policy on the deployment of topical repellents for malaria prevention.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registry (ACTRN12616001434482).",2020,"In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233).","['infection in Myanmar', 'Between April 2015 and June 2016, a 15-month stepped-wedge cluster randomised trial was conducted in 116 villages in Myanmar (stepped monthly in blocks', 'village health volunteer networks against\xa0Plasmodium spp', 'The median age of participants was 18 years, approximately half were female, and the majority were either village residents (46%) or forest dwellers (40']","['diethylbenzamide w/w cream distributed by VHVs, on Plasmodium spp', 'village health volunteer (VHV) network in the Greater Mekong Subregion (GMS']","['infection rate and potential geographic dilution', 'protection against RDT-detectable infection', 'rapid diagnostic test (RDT) (primary outcome) and polymerase chain reaction (PCR', 'incremental cost-effectiveness ratio', 'adverse events', 'Overall Plasmodium infection']","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086312', 'cui_str': 'Forest'}]","[{'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]",,0.250486,"In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233).","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Agius', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Cutts', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Han Oo', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Thi', 'Affiliation': 'Department of Public Health, Myanmar Ministry of Health and Sports, Nay Pyi Taw, Myanmar.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': ""O'Flaherty"", 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Kyaw', 'Initials': 'K', 'LastName': 'Zayar Aung', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Htin', 'Initials': 'H', 'LastName': 'Kyaw Thu', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Poe', 'Initials': 'P', 'LastName': 'Poe Aung', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Myat', 'Initials': 'M', 'LastName': 'Mon Thein', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Nyi', 'Initials': 'N', 'LastName': 'Nyi Zaw', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Wai', 'Initials': 'W', 'LastName': 'Yan Min Htay', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Paing Soe', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Razook', 'Affiliation': 'Population Health and Immunity Division, Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alyssa E', 'Initials': 'AE', 'LastName': 'Barry', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Htike', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Simpson', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brendan S', 'Initials': 'BS', 'LastName': 'Crabb', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Beeson', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Naanki', 'Initials': 'N', 'LastName': 'Pasricha', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Freya J I', 'Initials': 'FJI', 'LastName': 'Fowkes', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}]",PLoS medicine,['10.1371/journal.pmed.1003177']
1731,32822653,The plasma levels of atrial natriuretic peptide and brain natriuretic peptide in type 2 diabetes treated with sodium-glucose cotransporter-2 inhibitor.,"PURPOSE


The aim of this study was to determine the levels of atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) after treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitor or dipeptidyl peptidase-4 (DPP4) inhibitor in patients with type-2 diabetes inadequately controlled by insulin, and to determine whether variation in ANP levels can explain favorable cardiovascular outcome.
METHODS


We enrolled 56 patients, aged 18-80years, with type-2 diabetes inadequately controlled by insulin: i.e., HbA1c level 7.5-10.5% despite at least 8weeks' injectable insulin at a stable mean dose of 20-150IU daily, with or without no more than two oral antidiabetic agents.
FINDINGS


The 56 patients were randomized between 3 treatment groups: SGLT2 inhibitor (n=18), DPP4 inhibitor (n=19) and placebo (n=19). Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all showed significantly lower HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24weeks than controls. SGLT2 inhibitor treatment decreased ANP levels, BNP levels, systolic blood pressure and weight compared with placebo. Compared to those receiving DPP4 inhibitor, patients receiving SGLT2 inhibitor showed lower HbA1c levels (7.01 vs. 7.58%; P=0.03), ANP levels (28.41 vs. 43.03 pg/mL; P=0.00) and weight (66.14 vs. 71.76 kg; P=0.04) at 24weeks after adjusting for baseline values. The SGLT2 inhibitor group showed higher sodium concentrations than the placebo and DPP4 inhibitor groups (145.89 vs. 143.89 and 144.79 mmol/L, respectively; P=0.00 and P=0.04) at 24 weeks. ANP and BNP levels did not significantly correlate with HbA1c and blood glucose levels.
IMPLICATIONS


These results indicated that SGLT2 inhibitors may be superior to DPP4 inhibitors in reducing risk of cardiovascular disease in diabetic patients. The major study limitation was the small number of patients per group, which should be enlarged in further research.",2020,"Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all had significantly decreased HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24 weeks compared with patients treated with a placebo.","['patients with diabetes', '56 patients with type 2 diabetes mellitus that was inadequately controlled with insulin; the subjects were all 18∼80 years of age', 'A total of 56 patients', 'patients with type 2 diabetes mellitus', 'patients who still experienced inadequate glycaemic control (HbA1c levels of 7.5∼10.5 %) were recruited']","['DPP4 inhibitor', 'placebo', 'SGLT2 inhibitor', 'SGLT2', 'sodium-glucose cotransporter-2 inhibitor', 'SGLT2 inhibitor or DPP4 inhibitor', 'injectable insulin daily combined with or without no more than two oral antidiabetic agents']","['ANP and BNP levels', 'weight', 'levels of atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP', 'sodium concentrations', 'plasma levels of atrial natriuretic peptide and brain natriuretic peptide', 'ANP levels', 'HbA1c and blood glucose levels', 'HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure', 'lower HbA1c levels', 'ANP levels, BNP levels, systolic blood pressure and weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",56.0,0.0715293,"Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all had significantly decreased HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24 weeks compared with patients treated with a placebo.","[{'ForeName': 'Xiu', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: show_clancy@foxmail.com.'}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Gu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: gqw9299@163.com.'}, {'ForeName': 'Gu', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: feifeigalt@163.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: happy_yuanlu@126.com.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: shygu@njmu.edu.cn.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68, Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: zhangying932@163.com.'}]",Annales d'endocrinologie,['10.1016/j.ando.2020.07.1113']
1732,32822656,Physiology-guided revascularization versus optimal medical therapy of nonculprit lesions in elderly patients with myocardial infarction: Rationale and design of the FIRE trial.,"BACKGROUND


Myocardial infarction (MI) in elderly patients is associated with unfavorable prognosis, and it is becoming an increasingly prevalent condition. The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD). Given the limited evidence available for elderly patients, it has not yet been established whether, as for younger patients, a complete revascularization strategy in MI patients with MVD should be advocated. We present the design of a dedicated study that will address this research gap.
METHODS AND DESIGN


The FIRE trial is a prospective, randomized, international, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients aged 75 years and older, with MI (either STE or NSTE), MVD at coronary artery angiography, and a clear culprit lesion will be randomized to culprit-only treatment or to physiology-guided complete revascularization. The primary end point will be the patient-oriented composite end point of all-cause death, any MI, any stroke, and any revascularization at 1 year. The key secondary end point will be the composite of cardiovascular death and MI. Quality of life and physical performance will be evaluated as well. All components of the primary and key secondary outcome will be tested also at 3 and 5 years. The sample size for the study is 1,400 patients.
IMPLICATIONS


The FIRE trial will provide evidence on whether a specific revascularization strategy should be applied to elderly patients presenting MI and MVD to improve their clinical outcomes.",2020,"The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD).","['1400 patients', 'elderly patients with myocardial infarction', 'Patients aged 75years and older, with MI (either STE or NSTE), MVD at coronary artery angiography and a clear culprit lesion', 'elderly patients']",['Physiology-guided revascularization versus optimal medical therapy'],"['patient-oriented composite endpoint (POCE) of all cause death, any MI, any stroke, any revascularization at one year', 'composite of cardiovascular death and MI', 'Quality of life and physical performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0629355,"The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD).","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Biscaglia', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy. Electronic address: bscsmn@unife.it.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Guiducci', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Viale Risorgimento 80, Reggio Emilia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Santarelli', 'Affiliation': 'Cardiovascular Department, Infermi Hospital, Viale Luigi Settembrini 2, Rimini, Italy.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Amat Santos', 'Affiliation': 'CIBERCV, Cardiology Department, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Fernandez-Aviles', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, CIBERCV, Calle del Dr Esquerdo 46, Madrid, Spain; Universidad Carlos III, Calle Madrid 126, Madrid, Spain.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Lanzilotti', 'Affiliation': 'U.O.C. Cardiologia, Ospedale Maggiore, Largo Nigrisoli 2, Bologna, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Department of Cardiology, Infermi Hospital, Rivoli, Italy; Department of Cardiology, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Fileti', 'Affiliation': 'Cardiology Department, S. Maria delle Croci Hospital, Viale Randi 5, Ravenna, Italy.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Instituto de Investigación Hospital La Paz (IDIPAZ), University Hospital La Paz, Madrid, Spain, Madrid; Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giannini', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}, {'ForeName': 'Iginio', 'Initials': 'I', 'LastName': 'Colaiori', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Viale Risorgimento 80, Reggio Emilia, Italy.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Menozzi', 'Affiliation': 'Cardiovascular Department, Infermi Hospital, Viale Luigi Settembrini 2, Rimini, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Redondo', 'Affiliation': 'CIBERCV, Cardiology Department, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ruozzi', 'Affiliation': 'Cardiology Unit, Ospedale Civile di Baggiovara, Modena, Italy.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gutiérrez Ibañes', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, CIBERCV, Calle del Dr Esquerdo 46, Madrid, Spain; Universidad Carlos III, Calle Madrid 126, Madrid, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Díez Gil', 'Affiliation': 'Servicio de Cardiología, H. Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Biondi Zoccai', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Calle del Prof Martin Lagos s/n, Madrid, Spain.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Tebaldi', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University, Via Pansini, Naples, Italy.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy; Institute of Cardiology, Jagiellonian University Medical College, ul. Sw Anny 12, Krakow, Poland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy; Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}]",American heart journal,['10.1016/j.ahj.2020.08.007']
1733,32843370,Pansomatostatin Agonist Pasireotide Long-Acting Release for Patients with Autosomal Dominant Polycystic Kidney or Liver Disease with Severe Liver Involvement: A Randomized Clinical Trial.,"BACKGROUND AND OBJECTIVES


We assessed safety and efficacy of another somatostatin receptor analog, pasireotide long-acting release, in severe polycystic liver disease and autosomal dominant polycystic kidney disease. Pasireotide long-acting release, with its broader binding profile and higher affinity to known somatostatin receptors, has potential for greater efficacy.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Individuals with severe polycystic liver disease were assigned in a 2:1 ratio in a 1-year, double-blind, randomized trial to receive pasireotide long-acting release or placebo. Primary outcome was change in total liver volume; secondary outcomes were change in total kidney volume, eGFR, and quality of life.
RESULTS


Of 48 subjects randomized, 41 completed total liver volume measurements ( n =29 pasireotide long-acting release and  n =12 placebo). From baseline, there were -99±189 ml/m absolute and -3%±7% change in annualized change in height-adjusted total liver volume (from 2582±1381 to 2479±1317 ml/m) in the pasireotide long-acting release group compared with 136±117 ml/m absolute and 6%±7% increase (from 2387±759 to 2533±770 ml/m) in placebo ( P <0.001 for both). Total kidney volumes decreased by -12±34 ml/m and -1%±4% in pasireotide long-acting release compared with 21±21 ml/m and 4%±5% increase in the placebo group ( P =0.05 for both). Changes in eGFR were similar between groups. Among the  n =48 randomized, adverse events included hyperglycemia (26 of 33 [79%] in pasireotide long-acting release versus four of 15 [27%] in the placebo group;  P <0.001), and among the 47 without diabetes at baseline, 19 of 32 (59%) in the pasireotide long-acting release group versus one of 15 (7%) in the placebo group developed diabetes ( P =0.001).
CONCLUSIONS


Another somatostatin analog, pasireotide long-acting release, slowed progressive increase in both total liver volume/total kidney volume growth rates without affecting GFR decline. Participants experienced higher frequency of adverse events (hyperglycemia and diabetes).
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Pasireotide LAR in Severe Polycystic Liver Disease, NCT01670110 PODCAST: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_08_28_CJN13661119.mp3.",2020,Total kidney volumes decreased by -12±34 ml/m and -1%±4% in pasireotide long-acting release compared with 21±21,"['48 subjects randomized, 41 completed total liver volume measurements ( n =29 pasireotide long-acting release and  n =12', 'Individuals with severe polycystic liver disease', 'severe polycystic liver disease and autosomal dominant polycystic kidney disease', 'Patients with Autosomal Dominant Polycystic Kidney or Liver Disease with Severe Liver Involvement']","['placebo', 'pasireotide long-acting release or placebo']","['Total kidney volumes', 'total kidney volume, eGFR, and quality of life', 'height-adjusted total liver volume', 'hyperglycemia', 'pasireotide long-acting release', 'change in total liver volume', 'frequency of adverse events (hyperglycemia and diabetes', 'Changes in eGFR']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0158683', 'cui_str': 'Congenital cystic disease of liver'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",48.0,0.527677,Total kidney volumes decreased by -12±34 ml/m and -1%±4% in pasireotide long-acting release compared with 21±21,"[{'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Hogan', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota hogan.marie@mayo.edu.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Chamberlin', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Vaughan', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Waits', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Banks', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Leistikow', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Oftsie', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Chuck', 'Initials': 'C', 'LastName': 'Madsen', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Edwards', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Glockner', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Walter K', 'Initials': 'WK', 'LastName': 'Kremers', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Harris', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'LaRusso', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Vicente E', 'Initials': 'VE', 'LastName': 'Torres', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Tatyana V', 'Initials': 'TV', 'LastName': 'Masyuk', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.13661119']
1734,32810146,"Effectiveness of a culturally appropriate intervention to prevent intimate partner violence and HIV transmission among men, women, and couples in rural Ethiopia: Findings from a cluster-randomized controlled trial.","BACKGROUND


Intimate partner violence (IPV) is associated with increased HIV risk and other adverse health and psychosocial outcomes. We assessed the impact of Unite for a Better Life (UBL), a gender-transformative, participatory intervention delivered to men, women, and couples in Ethiopia in the context of the coffee ceremony, a traditional community-based discussion forum.
METHODS AND FINDINGS


Villages (n = 64) in 4 Ethiopian districts were randomly allocated to control, men's UBL, women's UBL, or couples' UBL, and approximately 106 households per village were randomly selected for inclusion in the trial. The intervention included 14 sessions delivered twice weekly by trained facilitators; control arm households were offered a short IPV educational session. Primary outcomes were women's experience of past-year physical or sexual IPV 24 months postintervention. Secondary outcomes included male perpetration of past-year physical or sexual IPV, comprehensive HIV knowledge, and condom use at last intercourse. Additional prespecified outcomes included experience and perpetration of past-year physical and/or sexual IPV and emotional IPV, HIV/AIDs knowledge and behaviors, decision-making, and gender norms. An intention-to-treat (ITT) analysis was conducted, evaluating 6,770 households surveyed at baseline in 2014-2015 (1,680 households, 16 clusters in control; 1,692 households, 16 clusters in couples' UBL; 1,707 households, 16 clusters in women's UBL; 1,691 households, 16 clusters in men's UBL). Follow-up data were available from 88% of baseline respondents and 87% of baseline spouses surveyed in 2017-2018. Results from both unadjusted and adjusted specifications are reported, the latter adjusting for age, education level, marriage length, polygamy, socioeconomic status, and months between intervention and endline. For primary outcomes, there was no effect of any UBL intervention compared to control on women's past-year experience of physical (couples' UBL arm adjusted odds ratio [AOR] = 1.00, 95% confidence interval [CI]: 0.77-1.30, p = 0.973; women's UBL arm AOR = 1.11, 95% CI 0.87-1.42, p = 0.414; men's UBL arm AOR = 1.02, 95% CI: 0.81-1.28, p = 0.865) or sexual IPV (couples' UBL arm AOR = 0.86, 95% CI: 0.62-1.20, p = 0.378; women's UBL arm AOR = 1.15, 95% CI: 0.89-1.50; p = 0.291; men's UBL arm AOR = 0.80, 95% CI: 0.63-1.01, p = 0.062). For the secondary outcomes, only the men's UBL intervention significantly reduced male perpetration of past-year sexual IPV (AOR: 0.73; 95% CI: 0.56-0.94, p = 0.014), and no intervention reduced perpetration of past-year physical IPV. Among women, the couples' UBL intervention significantly improved comprehensive HIV knowledge, and both couples' and women's UBL significantly increased reported condom use at last intercourse. Among additional outcomes of interest, the men's UBL intervention was associated with a significant reduction in women's experience of past-year physical and/or sexual IPV (AOR = 0.81, 95% CI: 0.66-0.99, p = 0.036) and men's perpetration of physical and/or sexual IPV (AOR = 0.78; 95% CI: 0.62-0.98, p = 0.037). UBL delivered to men and couples was associated with a significant reduction in HIV risk behaviors and more equitable intrahousehold decision-making and household task-sharing. The primary limitation is reliance on self-reported data.
CONCLUSIONS


A gender-transformative intervention delivered to men was effective in reducing self-reported perpetration of sexual IPV but did not reduce IPV when delivered to couples or women. We found evidence of decreased sexual IPV with men's UBL across men's and women's reports and of increased HIV knowledge and condom use at last intercourse among women. The men's UBL intervention could help accelerate progress towards gender equality and combating HIV/AIDS.
TRIAL REGISTRATION


The trial was prospectively registered at clinicaltrials.gov (NCT02311699) and in the American Economic Association registry (AEARCTR-0000211).",2020,"CONCLUSIONS


A gender-transformative intervention delivered to men was effective in reducing self-reported perpetration of sexual IPV but did not reduce IPV when delivered to couples or women.","[""6,770 households surveyed at baseline in 2014-2015 (1,680 households, 16 clusters in control; 1,692 households, 16 clusters in couples' UBL; 1,707 households, 16 clusters in women's UBL; 1,691 households, 16 clusters in men's UBL"", 'men, women, and couples in Ethiopia in the context of the coffee ceremony, a traditional community-based discussion forum', 'Intimate partner violence (IPV', 'men, women, and couples in rural Ethiopia', ""Villages (n = 64) in 4 Ethiopian districts were randomly allocated to control, men's UBL, women's UBL, or couples' UBL, and approximately 106 households per village""]","['culturally appropriate intervention', 'UBL', '14 sessions delivered twice weekly by trained facilitators; control arm households were offered a short IPV educational session', 'UBL intervention']","[""women's experience of past-year physical or sexual IPV 24 months postintervention"", 'sexual IPV', 'male perpetration of past-year sexual IPV', ""women's experience of past-year physical and/or sexual IPV"", 'intimate partner violence and HIV transmission', ""comprehensive HIV knowledge, and both couples' and women's UBL"", 'experience and perpetration of past-year physical and/or sexual IPV and emotional IPV, HIV/AIDs knowledge and behaviors, decision-making, and gender norms', 'HIV risk behaviors', ""women's past-year experience of physical"", ""men's perpetration of physical and/or sexual IPV"", 'male perpetration of past-year physical or sexual IPV, comprehensive HIV knowledge, and condom use at last intercourse']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",6770.0,0.220406,"CONCLUSIONS


A gender-transformative intervention delivered to men was effective in reducing self-reported perpetration of sexual IPV but did not reduce IPV when delivered to couples or women.","[{'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Abdul Latif Jameel Poverty Action Lab, Massachusetts Institute of Technology, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Leight', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Verani', 'Affiliation': 'CARE, New York, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Tewolde', 'Affiliation': 'EngenderHealth, Addis Ababa, Ethiopia.'}, {'ForeName': 'Negussie', 'Initials': 'N', 'LastName': 'Deyessa', 'Affiliation': 'Ethiopian Public Health Association, Addis Ababa, Ethiopia.'}]",PLoS medicine,['10.1371/journal.pmed.1003274']
1735,32813887,Exploring novel systemic biomarker approaches in grass-pollen sublingual immunotherapy using omics.,"BACKGROUND


Sublingual allergen-specific immunotherapy (SLIT) intervention improves the control of grass pollen allergy by maintaining allergen tolerance after cessation. Despite its widespread use, little is known about systemic effects and kinetics associated to SLIT, as well as the influence of the patient sensitization phenotype (Mono- or Poly-sensitized). In this quest, omics sciences could help to gain new insights to understand SLIT effects.
METHODS


47 grass-pollen-allergic patients were enrolled in a double-blind, placebo-controlled, multicenter trial using GRAZAX® during 2 years. Immunological assays (sIgE, sIgG4, and ISAC) were carried out to 31 patients who finished the trial. Additionally, serum and PBMCs samples were analyzed by metabolomics and transcriptomics, respectively. Based on their sensitization level, 22 patients were allocated in Mono- or Poly-sensitized groups, excluding patients allergic to epithelia. Individuals were compared based on their treatment (Active/Placebo) and sensitization level (Mono/Poly).
RESULTS


Kinetics of serological changes agreed with those previously described. At two years of SLIT, there are scarce systemic changes that could be associated to improvement in systemic inflammation. Poly-sensitized patients presented a higher inflammation at inclusion, while Mono-sensitized patients presented a reduced activity of mast cells and phagocytes as an effect of the treatment.
CONCLUSIONS


The most relevant systemic change detected after two years of SLIT was the desensitization of effector cells, which was only detected in Mono-sensitized patients. This change may be related to the clinical improvement, as previously reported, and, together with the other results, may explain why clinical effect is lost if SLIT is discontinued at this point.",2020,"Poli-sensitized patients presented a higher inflammation at inclusion, while Mono-sensitized patients presented a reduced activity of mast cells and phagocytes as an effect of the treatment.
","['31 patients who finished the trial', '47 grass-pollen-allergic patients', '22 patients were allocated in Mono or Poli-sensitized groups, excluding patients allergic to epithelia']","['Placebo) and sensitization level (Mono/Poli', 'GRAZAX®', 'Sublingual allergen-specific immunotherapy (SLIT) intervention', 'placebo']","['sIgE, sIgG4 and ISAC', 'serum and PBMCs samples', 'systemic inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0032400', 'cui_str': 'Poly(rA)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0032400', 'cui_str': 'Poly(rA)'}, {'cui': 'C2935532', 'cui_str': 'Grazax'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",22.0,0.327353,"Poli-sensitized patients presented a higher inflammation at inclusion, while Mono-sensitized patients presented a reduced activity of mast cells and phagocytes as an effect of the treatment.
","[{'ForeName': 'Tomas Clive', 'Initials': 'TC', 'LastName': 'Barker-Tejeda', 'Affiliation': 'Facultad de Farmacia, Centro de Metabolómica y Bioanálisis (CEMBIO), Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Madrid, España.'}, {'ForeName': 'Raphaelle', 'Initials': 'R', 'LastName': 'Bazire', 'Affiliation': 'Servicio de Alergia, Instituto de Investigación Sanitaria Princesa (IP), Hospital Universitario de La Princesa, Madrid, España.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Obeso', 'Affiliation': 'Facultad de Farmacia, Centro de Metabolómica y Bioanálisis (CEMBIO), Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Madrid, España.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Mera-Berriatua', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Rosace', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vazquez-Cortes', 'Affiliation': 'Servicio de Alergia, Hospital Clínico San Carlos, Universidad Complutense, IdISSC, Madrid, España.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Ramos', 'Affiliation': 'Servicio de Alergia, Instituto de Investigación Sanitaria Princesa (IP), Hospital Universitario de La Princesa, Madrid, España.'}, {'ForeName': 'Maria Del Pilar', 'Initials': 'MDP', 'LastName': 'Rico', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Chivato', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Barbas', 'Affiliation': 'Facultad de Farmacia, Centro de Metabolómica y Bioanálisis (CEMBIO), Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Madrid, España.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Villaseñor', 'Affiliation': 'Facultad de Farmacia, Centro de Metabolómica y Bioanálisis (CEMBIO), Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Madrid, España.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Escribese', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fernández-Rivas', 'Affiliation': 'Servicio de Alergia, Hospital Clínico San Carlos, Universidad Complutense, IdISSC, Madrid, España.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Blanco', 'Affiliation': 'Servicio de Alergia, Instituto de Investigación Sanitaria Princesa (IP), Hospital Universitario de La Princesa, Madrid, España.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Barber', 'Affiliation': 'Facultad de Medicina, Departamento de Ciencias Médicas Básicas, Instituto de Medicina Molecular Aplicada (IMMA), Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}]",Allergy,['10.1111/all.14565']
1736,32814640,"Assessment of indirect protection from maternal influenza immunization among non-vaccinated household family members in a randomized controlled trial in Sarlahi, Nepal.","Influenza is a significant cause of morbidity and mortality worldwide, and the World Health Organization highly recommends maternal vaccination during pregnancy. The indirect effect of maternal vaccination on other close contacts other than newborns is unknown. To evaluate this, we conducted a nested substudy between 2011 and 2012 of influenza and acute respiratory illness (ARI) among household members of pregnant women enrolled in a randomized placebo-controlled trial of antenatal influenza vaccination in the rural district of Sarlahi, Nepal. Women were assigned to receive influenza vaccination or placebo during pregnancy and then they and their household members were followed up to 6 months postpartum with weekly symptom surveillance and nasal swab collection. Swabs were tested by RT-PCR for influenza. Rates of laboratory-confirmed influenza and of ARI were compared between vaccine and placebo groups using generalized estimating equations with a Poisson link function. Overall, 1752 individuals in 520 households were eligible for inclusion. There were 82 laboratory-confirmed influenza illness episodes, for a rate of 7.0 per 100 person-years overall. Of the influenza strains able to be typed, 29 were influenza A, 40 were influenza B, and 6 were coinfections with influenza A and B. The rate did not differ significantly whether the household was in the vaccine or placebo group (rate ratio (RR) 1.37, 95% confidence interval (CI) 0.83-2.26). The rate of ARI was 28.5 per 100 person-years overall and did not differ by household group (RR 0.99, 95% CI 0.72-1.36). Influenza vaccination of pregnant women did not provide indirect protection of unvaccinated household members.",2020,"The rate of ARI was 28.5 per 100 person-years overall and did not differ by household group (RR 0.99, 95% CI 0.72-1.36).","['non-vaccinated household family members', 'unvaccinated household members', 'nested substudy between 2011 and 2012 of influenza and acute respiratory illness (ARI) among household members of pregnant women enrolled in a randomized', 'in the rural district of Sarlahi, Nepal', '1752 individuals in 520 households were eligible for inclusion', 'pregnant women']","['antenatal influenza vaccination', 'indirect protection from maternal influenza immunization', 'influenza vaccination or placebo', 'placebo']","['rate ratio (RR', 'rate of ARI']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",520.0,0.63193,"The rate of ARI was 28.5 per 100 person-years overall and did not differ by household group (RR 0.99, 95% CI 0.72-1.36).","[{'ForeName': 'Kira L', 'Initials': 'KL', 'LastName': 'Newman', 'Affiliation': 'School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Laveta M', 'Initials': 'LM', 'LastName': 'Stewart', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Scott', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Englund', 'Affiliation': ""Seattle Children's Hospital and Research Foundation, University of Washington, Seattle, WA, USA.""}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project, Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Nepal Nutrition Intervention Project, Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Laxman', 'Initials': 'L', 'LastName': 'Shrestha', 'Affiliation': 'Tribhuvan University, Department of Pediatrics and Child Health, Institute of Medicine, Kathmandu, Nepal.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Kuypers', 'Affiliation': 'School of Medicine, University of Washington, Molecular Virology Laboratory, Seattle, WA, USA.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'School of Medicine, University of Washington, Seattle, WA, USA. Electronic address: helenchu@uw.edu.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.08.014']
1737,32815423,Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy.,"Injectable therapies such as glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin are high-efficacy options for people with type 2 diabetes (T2D) who require treatment intensification. In addition to high glycemic efficacy, GLP-1RAs offer weight loss benefits, and some agents have been shown to reduce cardiovascular risk. This article summarizes data from two clinical studies with the first oral GLP-1RA, oral semaglutide, in situations where injectable therapy is often considered, and provides guidance on use in primary care. PIONEER 4 compared oral semaglutide 14 mg with an injectable GLP-1RA, liraglutide 1.8 mg, or placebo in patients uncontrolled on oral glucose-lowering therapies. PIONEER 8 compared oral semaglutide with placebo in patients with T2D already on insulin therapy. Treatment with oral semaglutide gave similar reductions in glycated hemoglobin (HbA 1   c ) compared with liraglutide at 26 weeks, and significantly greater reductions at 52 weeks. Changes in body weight with oral semaglutide were significantly greater compared with liraglutide after 26 and 52 weeks. Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1   c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage. Oral semaglutide was associated with low proportions of patients experiencing severe or blood-glucose-confirmed symptomatic hypoglycemia when added to oral glucose-lowering therapies, and did not increase the incidence of such events when added to insulin. The tolerability profile of oral semaglutide was consistent with that seen for injectable GLP-1RAs, with gastrointestinal side effects seen most frequently; most were transient and tended to occur during dose escalation. For patients requiring treatment intensification after oral therapy or as add-on to insulin, oral semaglutide provides effective glucose lowering and body weight loss, with low risk of hypoglycemia, thus broadening the range of therapeutic options for treatment of T2D in primary care.",2020,"Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage.","['people with type 2 diabetes (T2D) who require treatment intensification', 'patients with T2D already on insulin therapy', 'patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy', 'patients uncontrolled on oral glucose-lowering therapies']","['liraglutide', 'oral semaglutide', 'oral semaglutide 14 mg with an injectable GLP-1RA, liraglutide 1.8 mg, or placebo', 'glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin', 'placebo']","['HbA 1c  and body weight', 'body weight with oral semaglutide', 'total daily insulin dosage', 'body weight loss', 'low proportions of patients experiencing severe or blood-glucose-confirmed symptomatic hypoglycemia', 'glycated hemoglobin (HbA 1c ', 'tolerability profile of oral semaglutide']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0294087,"Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage.","[{'ForeName': 'Eugene E', 'Initials': 'EE', 'LastName': 'Wright', 'Affiliation': 'Charlotte Area Health Education Center , Charlotte, NC, USA.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital; Harvard Medical School , Boston, MA, USA.""}]",Postgraduate medicine,['10.1080/00325481.2020.1798127']
1738,32818475,"Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a prospective, multicenter, randomized trial.","BACKGROUND


Provoked vestibulodynia is the most common subtype of chronic vulvar pain. This highly prevalent and debilitating condition is characterized by acute recurrent pain located at the entry of the vagina in response to pressure application or attempted vaginal penetration. Although physical therapy is advocated as a first-line treatment for provoked vestibulodynia, evidence supporting its efficacy is scarce.
OBJECTIVE


The purpose of this study was to establish the efficacy of multimodal physical therapy compared with topical lidocaine, a frequently used first-line treatment.
STUDY DESIGN


We conducted a prospective, multicenter, parallel-group, randomized clinical trial in women diagnosed as having provoked vestibulodynia recruited from the community and 4 Canadian university hospitals. Women were randomly assigned (1:1) to receive either weekly sessions of physical therapy or overnight topical lidocaine (5% ointment) for 10 weeks. Randomization was stratified by center using random permuted blocks from a computer-generated list managed by an independent individual. Physical therapy entailed education, pelvic floor muscle exercises with biofeedback, manual therapy, and dilation. Assessments were conducted at baseline, posttreatment, and 6-month follow-up. Outcome assessors, investigators, and data analysts were masked to allocation. The primary outcome was pain intensity during intercourse evaluated with the numeric rating scale (0-10). Secondary outcomes included pain quality (McGill-Melzack Pain Questionnaire), sexual function (Female Sexual Function Index), sexual distress (Female Sexual Distress Scale), satisfaction (numeric rating scale of 0-10), and participants' impression of change (Patient Global Impression of Change). Intention-to-treat analyses were conducted using piecewise linear-growth models.
RESULTS


Among 212 women who were recruited and randomized, 201 (95%) completed the posttreatment assessment and 195 (92%) completed the 6-month follow-up. Multimodal physical therapy was more effective than lidocaine for reducing pain intensity during intercourse (between-group pre-post slope difference, P<.001; mean group postdifference, 1.8; 95% confidence interval, 1.2-2.3), and results were maintained at 6-month follow-up (mean group difference, 1.8; 95% confidence interval, 1.2-2.5). The physical therapy group also performed better than the lidocaine group in all secondary outcomes (pain quality, sexual function, sexual distress, satisfaction, and participants' impression of change) at posttreatment and 6-month follow-up. Moreover, the changes observed after physical therapy were shown to be clinically meaningful. Regarding participants' impression of change, 79% of women in the physical therapy group reported being very much or much improved compared with 39% in the lidocaine group (P<.001).
CONCLUSION


The findings provide strong evidence that physical therapy is effective for pain, sexual function, and sexual distress and support its recommendation as the first-line treatment of choice for provoked vestibulodynia.",2020,"The physical therapy group also performed better than the lidocaine group in all secondary outcomes (pain quality, sexual function, sexual distress, satisfaction and participants' impression of change) at post-treatment and 6-month follow-up.","['provoked vestibulodynia', '212 women recruited and randomized, 201 (95%) completed the post-treatment assessment and 195 (92%) the 6-month follow-up', 'women diagnosed with provoked vestibulodynia recruited from the community and four Canadian university hospitals']","['Physical therapy entailed education, pelvic floor muscle exercises with biofeedback, manual therapy and dilation', 'lidocaine', 'physical therapy', 'multimodal physical therapy', 'Physical therapy', 'topical lidocaine', 'physical therapy or overnight topical lidocaine', 'Multimodal physical therapy versus topical lidocaine', 'Multimodal physical therapy']","['pain, sexual function and sexual distress', ""pain quality, sexual function, sexual distress, satisfaction and participants' impression of change"", 'pain intensity during intercourse evaluated with the numerical rating scale', ""pain quality (McGill-Melzack pain questionnaire), sexual function (Female Sexual Function Index), sexual distress (Female Sexual Distress Scale), satisfaction (NRS 0-10) and participants' impression of change (The Patient's Global Impression of Change"", 'pain intensity during intercourse']","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",212.0,0.102992,"The physical therapy group also performed better than the lidocaine group in all secondary outcomes (pain quality, sexual function, sexual distress, satisfaction and participants' impression of change) at post-treatment and 6-month follow-up.","[{'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke and Research Center of the Centre hospitalier de l'Université de Sherbrooke, Sherbrooke, QC, Canada. Electronic address: Melanie.M.Morin@usherbrooke.ca.""}, {'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Dumoulin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut universitaire de gériatrie de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bergeron', 'Affiliation': 'Department of Psychology, University de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mayrand', 'Affiliation': ""Departments of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal and Research Center of the Centre hospitalier de l'Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Khalifé', 'Affiliation': 'Jewish General Hospital and Royal Victoria Hospital, McGill University Health Center, Montréal, QC, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Waddell', 'Affiliation': ""Department of Obstetrics and Gynecology, Centre hospitalier de l'Université de Sherbrooke and Université de Sherbrooke, Sherbrooke, QC, Canada.""}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Dubois', 'Affiliation': 'Department of Community Health Sciences, Faculty of Medicine and Health Sciences, Université de Sherbrooke and Research Center on Aging, Sherbrooke, QC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.08.038']
1739,32821284,Combined Aerobic and Resistance Exercises Evokes Longer Reductions on Ambulatory Blood Pressure in Resistant Hypertension: A Randomized Crossover Trial.,"Aim


The present study compared the acute effects of aerobic (AER), resistance (RES), and combined (COM) exercises on blood pressure (BP) levels in people with resistant hypertension (RH) and nonresistant hypertension (NON-RH).
Methods


Twenty patients (10 RH and 10 NON-RH) were recruited and randomly performed three exercise sessions and a control session. Ambulatory BP was monitored over 24 hours after each experimental session.
Results


Significant reductions on ambulatory BP were found in people with RH after AER, RES, and COM sessions. Notably, ambulatory BP was reduced during awake-time and night-time periods after COM. On the other hand, the effects of AER were more prominent during awake periods, while RES caused greater reductions during the night-time period. In NON-RH, only RES acutely reduced systolic BP, while diastolic BP was reduced after all exercise sessions. However, the longest postexercise ambulatory hypotension was observed after AER (~11 h) in comparison to RES (~8 h) and COM (~4 h) exercises.
Conclusion


Findings of the present study indicate that AER, RES, and COM exercises elicit systolic and diastolic postexercise ambulatory hypotension in RH patients. Notably, longer hypotension periods were observed after COM exercise. In addition, NON-RH and RH people showed different changes on BP after exercise sessions, suggesting that postexercise hypotension is influenced by the pathophysiological bases of hypertension.",2020,"Significant reductions on ambulatory BP were found in people with RH after AER, RES, and COM sessions.","['Twenty patients (10 RH and 10 NON-RH', 'Resistant Hypertension', 'people with resistant hypertension (RH) and nonresistant hypertension (NON-RH', 'RH patients']","['exercise sessions and a control session', 'Combined Aerobic and Resistance Exercises Evokes', 'aerobic (AER), resistance (RES), and combined (COM) exercises']","['AER, RES, and COM exercises elicit systolic and diastolic postexercise ambulatory hypotension', 'BP', 'ambulatory BP', 'Ambulatory Blood Pressure', 'systolic BP, while diastolic BP', 'longest postexercise ambulatory hypotension', 'longer hypotension periods', 'postexercise hypotension', 'Ambulatory BP', 'blood pressure (BP) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0262751,"Significant reductions on ambulatory BP were found in people with RH after AER, RES, and COM sessions.","[{'ForeName': 'Nayara Fraccari', 'Initials': 'NF', 'LastName': 'Pires', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Helio José', 'Initials': 'HJ', 'LastName': 'Coelho-Júnior', 'Affiliation': 'Laboratory of Cardiovascular Investigation and Exercise, School of Physical Education (FEF), University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Bruno Bavaresco', 'Initials': 'BB', 'LastName': 'Gambassi', 'Affiliation': 'Laboratory of Cardiovascular Investigation and Exercise, School of Physical Education (FEF), University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Ana Paula Cabral', 'Initials': 'APC', 'LastName': 'de Faria', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Alessandra Mileni Versuti', 'Initials': 'AMV', 'LastName': 'Ritter', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'de Andrade Barboza', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Silvia Elaine', 'Initials': 'SE', 'LastName': 'Ferreira-Melo', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Rodrigues', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Heitor Moreno', 'Initials': 'HM', 'LastName': 'Júnior', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}]",Cardiovascular therapeutics,['10.1155/2020/8157858']
1740,32817266,Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease.,"OBJECTIVES


To test the effect of a 4-month telehealth home monitoring program (REACH), layered on usual care, on postdischarge outcomes in parents of infants recovering from cardiac surgery and their infants.
METHODS


Randomized trial of infants discharged from the hospital after cardiac surgery for congenital heart disease. Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers.
RESULTS


From 2012 to 2016, 219 parent-infant dyads were enrolled; 109 were randomly assigned to the intervention group and 110 to the control group. At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61). The percentages of parents who met posttraumatic stress disorder (PTSD) criteria and parent quality of life inventory scores were also not significantly different between the 2 groups (PTSD in the intervention group was 18% and was 18% in the control group;  P  =.56; the mean Ulm Quality of Life Inventory for Parents in the intervention group was 71 andwas 70 in the control group;  P  = .88). Infant growth in both groups was suboptimal (the mean weight-for-age  z  scores were -1.1 in the intervention group and -1.2 in the control group;  P  = .56), and more infants in the intervention group were readmitted to the hospital (66% in the intervention group versus 57% in the control group;  P  < .001).
CONCLUSIONS


When added to usual care, the REACH intervention was not associated with an improvement in parent or infant outcomes. Four months after neonatal heart surgery, ∼20% of parents demonstrate PTSD symptoms. Suboptimal infant growth and hospital readmissions were common.",2020,"At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61).","['Congenital Heart Disease', 'parents of infants recovering from cardiac surgery and their infants', 'From 2012 to 2016', '219 parent-infant dyads were enrolled; 109', 'Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers', 'infants discharged from the hospital after cardiac surgery for congenital heart disease']","['telehealth home monitoring program (REACH), layered on usual care']","['readmitted to the hospital', 'Suboptimal infant growth and hospital readmissions', 'total Parenting Stress Index', 'posttraumatic stress disorder (PTSD) criteria and parent quality of life inventory scores', 'Infant growth', 'parenting stress', 'mean Ulm Quality of Life Inventory']","[{'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0471754,"At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61).","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Medoff Cooper', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania; medoff@upenn.edu.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Marino', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Desiree A', 'Initials': 'DA', 'LastName': 'Fleck', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Amy Jo', 'Initials': 'AJ', 'LastName': 'Lisanti', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Golfenshtein', 'Affiliation': 'Department of Nursing, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Ravishankar', 'Affiliation': 'Division of Cardiology, Department of Pediatrics and.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Costello', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Hanlon', 'Affiliation': 'Department of Statistics, College of Science, Virginia Polytechnic Institute and State University, Blacksburg, Virginia; and.'}, {'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': 'Department of Anesthesia and Critical Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Pediatrics,['10.1542/peds.2020-0531']
1741,32826035,"Comment on: A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis.",,2020,,['Acute Bacterial Conjunctivitis'],['Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009768', 'cui_str': 'Bacterial conjunctivitis'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0706574', 'cui_str': 'Dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]'}]",[],,0.0247975,,"[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kanclerz', 'Affiliation': 'Gdańsk, Poland.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Myers', 'Affiliation': 'Chicago, Illinois, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.04.045']
1742,32826036,"Reply to Comment on: A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis.",,2020,,['Acute Bacterial Conjunctivitis'],['Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009768', 'cui_str': 'Bacterial conjunctivitis'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0706574', 'cui_str': 'Dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]'}]",[],,0.0214747,,"[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Ta', 'Affiliation': 'Palo Alto, California, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Raizman', 'Affiliation': 'Boston, Massachusetts, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Gross', 'Affiliation': 'Dallas, Texas, USA.'}, {'ForeName': 'Sunir', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Fort Lauderdale, Florida, USA.'}, {'ForeName': 'Sushanta', 'Initials': 'S', 'LastName': 'Mallick', 'Affiliation': 'Lexington, Massachusetts, USA.'}, {'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Lexington, Massachusetts, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Segal', 'Affiliation': 'Delray Beach, Florida, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.006']
1743,32826776,Tailored to Fit: How an Implementation Framework Can Support Pragmatic Pain Care Trial Adaptation for Diverse Veterans Affairs Clinical Settings.,"BACKGROUND


Veterans Affairs (VA) has rolled out a holistic, multicomponent Whole Health care model nationwide, yet no pragmatic trials have been conducted in real-world clinical settings to compare its effectiveness against other evidence-based approaches for chronic pain management in veterans.
OBJECTIVES


We describe the adaptation of the first large pragmatic randomized controlled trial of the Whole Health model for chronic pain care for diverse VA clinical settings.
RESEARCH DESIGN


Informed by the Promoting Action on Research Implementation in Health Systems implementation framework, we conducted qualitative semistructured interviews to obtain feedback on trial design from VA leadership, frontline clinicians, and veterans with chronic pain at 5 VA enrollment sites. Next, we convened in-person evidence-based quality improvement (EBQI) meetings with study stakeholders (including frontline clinicians and administrators) at each site to discuss study design; review interview themes; and identify site-specific barriers, facilitators, and approaches to implementation. Ethnographic observations from EBQI meetings provided additional insight into implementation strategies.
SUBJECTS


Seventy-four veteran and VA staff stakeholders were interviewed; 71 stakeholders participated in EBQI meetings.
RESULTS


At each site, unique clinical contexts and varying resources for Whole Health and pain care delivery affected plans for trial implementation. We present examples of local adaptations that emerged through the formative evaluation process to facilitate implementation and yield a more pragmatic trial design.
CONCLUSIONS


A systematic formative evaluation can facilitate engagement and buy-in of study stakeholders. Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.",2020,Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.,['Seventy-four veteran and VA staff stakeholders were interviewed; 71 stakeholders participated in EBQI meetings'],[],[],"[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]",[],[],,0.194153,Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.,"[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Purcell', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Becker', 'Affiliation': 'VA Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Kara A', 'Initials': 'KA', 'LastName': 'Zamora', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'McGrath', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Hildi J', 'Initials': 'HJ', 'LastName': 'Hagedorn', 'Affiliation': 'Minneapolis VA Health Care System.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Fabian', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'McCamish', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Seal', 'Affiliation': 'San Francisco VA Health Care System.'}]",Medical care,['10.1097/MLR.0000000000001376']
1744,32822347,Safety and parasite clearance of artemisinin-resistant Plasmodium falciparum infection: A pilot and a randomised volunteer infection study in Australia.,"BACKGROUND


Artemisinin resistance is threatening malaria control. We aimed to develop and test a human model of artemisinin-resistant (ART-R) Plasmodium falciparum to evaluate the efficacy of drugs against ART-R malaria.
METHODS AND FINDINGS


We conducted 2 sequential phase 1, single-centre, open-label clinical trials at Q-Pharm, Brisbane, Australia, using the induced blood-stage malaria (IBSM) model, whereby healthy participants are intravenously inoculated with blood-stage parasites. In a pilot study, participants were inoculated (Day 0) with approximately 2,800 viable P. falciparum ART-R parasites. In a comparative study, participants were randomised to receive approximately 2,800 viable P. falciparum ART-R (Day 0) or artemisinin-sensitive (ART-S) parasites (Day 1). In both studies, participants were administered a single approximately 2 mg/kg oral dose of artesunate (AS; Day 9). Primary outcomes were safety, ART-R parasite infectivity, and parasite clearance. In the pilot study, 2 participants were enrolled between April 27, 2017, and September 12, 2017, and included in final analyses (males n = 2 [100%], mean age = 26 years [range, 23-28 years]). In the comparative study, 25 participants were enrolled between October 26, 2017, and October 18, 2018, of whom 22 were inoculated and included in final analyses (ART-R infected participants: males n = 7 [53.8%], median age = 22 years [range, 18-40 years]; ART-S infected participants: males n = 5 [55.6%], median age = 28 years [range, 22-35 years]). In both studies, all participants inoculated with ART-R parasites became parasitaemic. A total of 36 adverse events were reported in the pilot study and 277 in the comparative study. Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious. Seven participants experienced transient severe falls in white cell counts and/or elevations in liver transaminase levels which were considered related to malaria. Additionally, 2 participants developed ventricular extrasystoles that were attributed to unmasking of a predisposition to benign fever-induced tachyarrhythmia. In the comparative study, parasite clearance half-life after AS was significantly longer for ART-R infected participants (n = 13, 6.5 hours; 95% confidence interval [CI] 6.3-6.7 hours) compared with ART-S infected participants (n = 9, 3.2 hours; 95% CI 3.0-3.3 hours; p < 0.001). The main limitation of this study was that the ART-R and ART-S parasite strains did not share the same genetic background.
CONCLUSIONS


We developed the first (to our knowledge) human model of ART-R malaria. The delayed clearance profile of ART-R parasites after AS aligns with field study observations. Although based on a relatively small sample size, results indicate that this model can be safely used to assess new drugs against ART-R P. falciparum.
TRIAL REGISTRATION


The studies were registered with the Australian New Zealand Clinical Trials Registry: ACTRN12617000244303 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372357) and ACTRN12617001394336 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373637).",2020,"Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious.","['healthy participants are intravenously inoculated with blood-stage parasites', '25 participants were enrolled between October 26, 2017, and October 18, 2018, of whom 22 were inoculated and included in final analyses (ART-R infected participants: males n = 7 [53.8%], median age = 22 years [range, 18-40 years]; ART-S infected participants: males n = 5 [55.6%], median age = 28 years [range, 22-35 years', 'participants were inoculated (Day 0) with approximately 2,800 viable P. falciparum ART-R parasites', 'volunteer infection study in Australia', '2 participants were enrolled between April 27, 2017, and September 12, 2017, and included in final analyses (males n = 2 [100%], mean age = 26 years [range, 23-28 years']","['receive approximately 2,800 viable P. falciparum ART-R (Day 0) or artemisinin-sensitive (ART-S) parasites (Day 1', 'artemisinin-resistant Plasmodium falciparum infection']","['ventricular extrasystoles', 'delayed clearance profile of ART-R parasites', 'headache, pyrexia, myalgia, nausea, and chills', 'safety, ART-R parasite infectivity, and parasite clearance', 'liver transaminase levels', 'transient severe falls']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0858318', 'cui_str': 'Plasmodium falciparum infection'}]","[{'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030657', 'cui_str': 'pathogenicity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",2.0,0.271382,"Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious.","[{'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Watts', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Odedra', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marquart', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Lachlan', 'Initials': 'L', 'LastName': 'Webb', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Azrin N', 'Initials': 'AN', 'LastName': 'Abd-Rahman', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cascales', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Chalon', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rebelo', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Zuleima', 'Initials': 'Z', 'LastName': 'Pava', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Cielo', 'Initials': 'C', 'LastName': 'Pasay', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Nanhua', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Australian Army Malaria Institute, Brisbane, Australia.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Peatey', 'Affiliation': 'Australian Army Malaria Institute, Brisbane, Australia.'}, {'ForeName': 'Jörg J', 'Initials': 'JJ', 'LastName': 'Möhrle', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'McCarthy', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003203']
1745,32822361,The effects of whole-body electromyostimulation (WB-EMS) in comparison to a multimodal treatment concept in patients with non-specific chronic back pain-A prospective clinical intervention study.,"BACKGROUND


According to present guidelines, active exercise is one key component in the comprehensive treatment of nonspecific chronic back pain (NSCBP). Whole body electromyostimulation (WB-EMS) is a safe, and time-effective training method, that may be effective in NSCBP-patients.
METHODS


In this prospective and controlled nonrandomized clinical study, two therapeutic approaches were compared. One group received 20 minutes WB-EMS per week. An active control group (ACG) received a multimodal therapy program. A third group included subjects without back pain. To all groups, the following measurement instruments were applied: Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), North American Spine Society Instrument (NASS); SF 36 survey and measurements for muscular function and postural stability. In the EMS-group: T0: baseline; T1: at 6 weeks; T2: at 12 weeks and T3: at 24 weeks. In the ACG: T0 baseline and T1 after 4 weeks.
RESULTS


In the intervention group, 128 patients with low back pain were enrolled, 85 in the WB-EMS group and 43 in the ACG. 34 subjects were allocated to the passive control group. The average age was 58.6 years (18-86 years). In the EMS group, the NRS (1-10) improved statistically and clinically significantly by 2 points. The ODI was reduced by 19.7 points. The NASS and most of the SF 36 items improved significantly. In the multimodal treatment group, only the muscular function improved slightly.
CONCLUSION


Our data support the hypothesis that WB-EMS is at least as effective as a multimodal treatment, which is often referred to as being the golden standard. Therefore WB-EMS may be an effective and, with 20 min./week training time, very time-efficient alternative to established multimodal treatment models.",2020,The NASS and most of the SF 36 items improved significantly.,"['The average age was 58.6 years (18-86 years', 'patients with non-specific chronic back pain', '128 patients with low back pain were enrolled, 85 in the WB-EMS group and 43 in the ACG', '34 subjects']","['Whole body electromyostimulation (WB-EMS', 'whole-body electromyostimulation (WB-EMS', 'multimodal therapy program']","['muscular function improved slightly', 'subjects without back pain', 'ODI', 'Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), North American Spine Society Instrument (NASS); SF 36 survey and measurements for muscular function and postural stability']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",128.0,0.022024,The NASS and most of the SF 36 items improved significantly.,"[{'ForeName': 'Karl Lorenz', 'Initials': 'KL', 'LastName': 'Konrad', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Baeyens', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy, Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Birkenmaier', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Anna Helena', 'Initials': 'AH', 'LastName': 'Ranker', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Widmann', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Leukert', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wenisch', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Kraft', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Jansson', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wegener', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}]",PloS one,['10.1371/journal.pone.0236780']
1746,32823200,Opposite effects of smoking and nicotine intake on cognition.,"Our main purpose was to investigate how smoking and nicotine interacted with specific aspects of cognitive functioning. The research was conducted in two parts: (i) an investigation of cognition in heavy smokers and healthy nonsmokers, and (ii) an investigation of cognition in healthy nonsmokers enrolled in a clinical trial involving administration of nicotine gum. Results indicated that the relationship between smoking and nicotine was characterized by an inverted U-shaped effect. On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here. On the other hand, healthy nonsmokers who used 2-mg of nicotine gum performed better, whilst the 4-mg group performed worse than the 2-mg and the placebo group. Demographic data were not related to the cognitive tasks. These data suggest that small doses of nicotine can have an activating function that leads to improved cognition, while heavy smoking on a chronic (and possibly acute) basis leads to cognitive impairment.",2020,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","['heavy smokers and healthy nonsmokers', 'healthy nonsmokers']","['nicotine', 'nicotine gum', 'placebo']",[],"[{'cui': 'C3494625', 'cui_str': 'Heavy tobacco smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0106464,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","[{'ForeName': 'Natalia L', 'Initials': 'NL', 'LastName': 'Almeida', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: natalialalmeida@hotmail.com.'}, {'ForeName': 'Stephanye J', 'Initials': 'SJ', 'LastName': 'Rodrigues', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Letícia M', 'Initials': 'LM', 'LastName': 'Gonçalves', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Silverstein', 'Affiliation': 'University of Rochester Medical Center, Department of Psychiatry, NY, USA.'}, {'ForeName': 'Isadora C', 'Initials': 'IC', 'LastName': 'Sousa', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Giulliana H', 'Initials': 'GH', 'LastName': 'Gomes', 'Affiliation': 'Medical Sciences College, Brazil.'}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Butler', 'Affiliation': 'Nathan Kline Institute for Psychiatric Research, NY, USA.'}, {'ForeName': 'Thiago P', 'Initials': 'TP', 'LastName': 'Fernandes', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: paivatm@gmail.com.'}, {'ForeName': 'Natanael A', 'Initials': 'NA', 'LastName': 'Santos', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}]",Psychiatry research,['10.1016/j.psychres.2020.113357']
1747,32827835,Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants.,"AIM


The quadrivalent human papillomavirus (4vHPV) vaccine has demonstrated efficacy and immunogenicity and was generally well tolerated in clinical trials conducted in Japan. We report a detailed safety analysis of injection-site reactions in female Japanese 4vHPV clinical trial participants.
METHODS


This post-hoc analysis included data from 2 double-blind, placebo-controlled phase II clinical trials of a 3-dose (Day 1, Month 2, Month 6) regimen of 4vHPV vaccine in Japanese young women aged 18-26 years (N = 1021; NCT00378560) and girls aged 9-17 years (N = 107; NCT00411749). Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials. Post-hoc analyses of data from these trials were performed to examine details of injection-site AEs, including day of onset, time from onset to resolution, and maximum intensity.
RESULTS


Injection-site AEs were reported by 85.6% of 4vHPV vaccine recipients and 72.4% of placebo recipients, most commonly erythema, pain, pruritus, and swelling (each >5% of 4vHPV vaccine recipients). The majority of injection-site AEs had an onset within 3 days of vaccination and were mild to moderate in intensity; few 4vHPV vaccine recipients reported severe injection-site AEs (2.0% overall). All injection-site AEs resolved, and most (4vHPV: 87.5%; placebo: 92.7%) resolved within 5 days of onset.
CONCLUSIONS


Most injection-site reactions are mild or moderate in intensity and of short duration. The 3-dose regimen of 4vHPV vaccine is well tolerated in Japanese female clinical trial participants based on this post-hoc analysis. These results will further support safety communication between healthcare providers and vaccine recipients regarding the HPV vaccine.
TRIAL REGISTRATION


Clinicaltrials. gov: NCT00378560 and NCT00411749.",2020,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"['female Japanese 4vHPV clinical trial participants', 'Japanese female clinical trial participants', 'Japanese young women aged 18-26 years (N\u202f=\u202f1021; NCT00378560) and girls aged 9-17 years (N\u202f=\u202f107; NCT00411749']","['vaccination with quadrivalent human papillomavirus vaccine', 'injection-site reactions', '4vHPV vaccine', 'quadrivalent human papillomavirus (4vHPV) vaccine', 'placebo']","['severe injection-site AEs', 'erythema, pain, pruritus, and swelling ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}]",,0.597729,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Murata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: shinya.murata@merck.com.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Shirakawa', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: masayoshi.shirakawa@merck.com.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Sugawara', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshie.sugawara@merck.com.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Shuto', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: michiko.shutou@merck.com.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sawata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: miyuki.sawata@merck.com.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshiyuki.tanaka@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100205']
1748,32827953,The strap intermuscular approach can significantly increase the exposure rate of the external branch of the superior laryngeal nerve during thyroid surgery.,"BACKGROUND


Avoiding injury to the external branch of the superior laryngeal nerve (EBSLN) is a major challenge during thyroid surgery. EBSLN injury can have an impact on the quality of life of patients. The aim of this study was to introduce the strap intermuscular approach, to dissect the EBSLN with two different approaches in thyroid surgery, to compare the differences between these two approaches, and to describe a way for surgeons to treat the upper thyroid gland to find the EBSLN.
METHODS


A prospective study of hemithyroidectomy was performed. In total, 104 patients were included and randomly divided into two groups: one group used the traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach. We described the surgical procedure for the strap intermuscular approach and compared the differences in the rates of EBSLN exposure, injury, and classification to illustrate the advantages of the intermuscular approach in thyroid surgery.
RESULTS


The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630). The exposure rate of EBSLNs classified as type 1 was higher in the strap intermuscular approach than in the traditional approach (30.77% vs. 13.46%, p = 0.033), with an OR and 95% CI of 0.350 (0.130-0.942).
CONCLUSIONS


The exposure rate of the EBSLN was significantly higher with the strap intermuscular approach method than with the traditional approach during thyroid surgery. This approach allows for better identification of the EBSLN during thyroidectomy.",2020,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).",['104 patients'],"['traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach', 'hemithyroidectomy']",['exposure rate of the EBSLN'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}]",104.0,0.0387604,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hei', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Runfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qinjianwu_62@163.com.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.004']
1749,32828931,Stable Symptom Clusters and Evolving Symptom Networks in Relation to Chemotherapy Cycles.,"CONTEXT


The existence of stable symptom clusters with variations or changes in cluster membership and the merging of symptom clusters over time urge us to investigate how symptom relationships change over time.
OBJECTIVES


To identify stable symptom clusters and understand networks among symptoms using longitudinal data.
METHODS


Secondary data analysis was conducted using data from a nonblinded randomized clinical trial, which evaluated the effect and feasibility of the developed cancer symptom management system. For the present study, data from all participants of the original trial were analyzed (N = 249). The severity of 20 symptoms was measured before the start of chemotherapy (CTx) and during the initial four cycles of CTx. Symptom clusters were identified using principal component and hierarchical cluster analyses, and network analysis was used to explore the relationships among symptoms.
RESULTS


Three common symptom clusters were identified. The first cluster consisted of anxiety, depression, sleep disturbance, pain, and dyspnea. Fatigue, difficulty concentrating, and drowsiness formed a second stable cluster throughout the CTx cycles. The third cluster comprised loss of appetite, taste change, nausea, and vomiting. In terms of the symptom networks, close relationships were recognized, irrespective of symptom severity level, between anxiety and depression, fatigue and drowsiness, and loss of appetite and taste change. Fatigue was the most central symptom with the highest strength. Edge thickening after starting CTx demonstrated evolving symptom networks in relation to CTx cycles.
CONCLUSION


Stable symptom clusters and evolving networks were identified. The most central symptom was fatigue; however, the paucity of studies that investigated symptom networks and central symptoms calls for further investigations on these phenomena. Identification of central symptoms and underlying mechanisms will guide efficient symptom management. Future studies will need to focus on developing comprehensive interventions for managing symptom clusters or targeting central symptoms.",2020,"In terms of the symptom networks, close relationships were recognized, irrespective of symptom severity level, between anxiety and depression, fatigue and drowsiness, and loss of appetite and taste change.",[],[],"['severity of 20 symptoms', 'anxiety and depression, fatigue and drowsiness, and loss of appetite and taste change', 'loss of appetite, taste change, nausea and vomiting', 'Fatigue, difficulty concentrating, and drowsiness', 'Fatigue', 'anxiety, depression, sleep disturbance, pain and dyspnea']",[],[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",,0.0475643,"In terms of the symptom networks, close relationships were recognized, irrespective of symptom severity level, between anxiety and depression, fatigue and drowsiness, and loss of appetite and taste change.","[{'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Rha', 'Affiliation': 'College of Medicine & Yonsei Cancer Center, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'College of Nursing & Mo-Im Kim Nursing Research Institute, Yonsei University, Seoul, Korea. Electronic address: jiyeonest@yuhs.ac.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.08.008']
1750,32846108,Efficacy of Bolus Calculation and Advanced Carbohydrate Counting in Type 2 Diabetes: A Randomized Clinical Trial.,"Background:  Carbohydrate counting and use of automated bolus calculators (ABCs) can help reduce HbA 1c  in type 1 diabetes but only limited evidence exists in type 2 diabetes. We evaluated the efficacy of advanced carbohydrate counting (ACC) and use of an ABC compared with manual insulin bolus calculation (MC) in persons with type 2 diabetes.  Materials and Methods:  A 24-week open-label, randomized clinical study was conducted in 79 persons with type 2 diabetes treated with basal-bolus insulin (mean age 62.5 ± 9.6 years, HbA 1c  8.7% ± 1.0% [72 ± 11 mmol/mol], diabetes duration 18.7 ± 7.6 years). Participants were randomized 1:1 into two groups: ABC group received training in ACC and use of an ABC; MC group received training in ACC and manual calculation of insulin bolus. Participants wore blinded continuous glucose monitors for 6 days at baseline and at study end. Primary endpoint was change in HbA 1c .  Results:  After 24 weeks, HbA 1c  decreased 0.8% (8.8 mmol/mol) in ABC group and 0.8% (9.0 mmol/mol) in MC group with no between-group difference ( P  = 0.96) and without increase in time in hypoglycemic range (sensor glucose <3.9 mmol/L). Glycemic variability decreased significantly in both groups, whereas the total insulin dose and body mass index (BMI) remained unchanged during the study. Treatment satisfaction increased significantly in both groups after 24 weeks.  Conclusion:  ACC is an effective, low-cost tool to reduce HbA 1c  and glycemic variability in persons with basal-bolus insulin-treated type 2 diabetes without increase in hypoglycemia or BMI. Similar effects were seen with use of an ABC and with use of manual bolus calculation.  Trial registration:  ClinicalTrials.gov NCT02887898.",2020,"ACC is an effective, low-cost tool to reduce HbA1c and glycaemic variability in persons with basal-bolus insulin treated type 2 diabetes without increase in hypoglycaemia or BMI.","['type 2 diabetes', '79 persons with type 2 diabetes treated with basal-bolus insulin (mean age 62.5±9.6 years, HbA1c 8.7±1.0% (72±11 mmol/mol), diabetes duration 18.7±7.6 years', 'persons with type 2 diabetes']","['manual insulin bolus calculation (MC', 'ABC group received training in ACC and use of an ABC; MC group received training in ACC and manual calculation of insulin bolus', 'ACC', 'blinded continuous glucose monitors (CGM', 'bolus calculator and advanced carbohydrate counting', 'advanced carbohydrate counting (ACC', 'Carbohydrate counting and use of automated bolus calculators (ABCs']","['hypoglycaemia or BMI', 'Glycaemic variability', 'HbA1c and glycaemic variability', 'time in hypoglycaemic range', 'change in HbA1c', 'Treatment satisfaction', 'total insulin dose and BMI']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",79.0,0.0586546,"ACC is an effective, low-cost tool to reduce HbA1c and glycaemic variability in persons with basal-bolus insulin treated type 2 diabetes without increase in hypoglycaemia or BMI.","[{'ForeName': 'Merete B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Nermin', 'Initials': 'N', 'LastName': 'Serifovski', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Anne M H', 'Initials': 'AMH', 'LastName': 'Herz', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hommel', 'Affiliation': 'Steno Diabetes Center Copenhagen, Clinical research, Gentofte, Denmark.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Raimond', 'Affiliation': 'Steno Diabetes Center Copenhagen, Clinical research, Gentofte, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Perrild', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Bispebjerg, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Gotfredsen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gæde', 'Affiliation': 'Department of Endocrinology, Slagelse Hospital, Slagelse, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Nørgaard', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Hvidovre, Denmark.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0276']
1751,32853740,Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement.,"Quality of life and patient satisfaction after ministernotomy have never been compared to conventional full sternotomy in randomized trials. The QUALITY-AVR trial is a single-blind, single-center, independent, randomized clinical trial comparing ministernotomy to full sternotomy in patients with isolated severe aortic stenosis scheduled for elective aortic valve replacement. One hundred patients were randomized in a 1:1 computational fashion. The primary endpoint was a difference between intervention groups of ≥0.10 points in change from baseline quality of life Questionnaire EuroQOL-index, measured at 1, 6, or 12 months. Secondary endpoints were differences in change from other baseline EuroQOL-index utilities, cardiac surgery-specific satisfaction questionnaire (SATISCORE), a combined safety endpoint of 4 major adverse complications at 1 month (all-cause mortality, acute myocardial infarction, neurologic events, and acute renal failure), bleeding through drains within the first 24 hours, intubation time, and other minor endpoints. Clinical follow-up was scheduled at baseline, 1, 6, and 12 months after randomization. Change from baseline mean difference EQ-5D-index was +0.20 points (95% confidence interval 0.10-0.30, P < 0.001) and median difference +0.14 (95% confidence interval 0.06-0.22, P < 0.001), favoring the ministernotomy group at 1 month. Patient satisfaction was also better at 1 month (Satiscore 83 ± 9 vs 77 ± 13 points; P = 0.010). The ministernotomy group had significantly less bleeding in the first 24 hours (299 ± 140 vs 509 ± 251 mL, P = 0.001). Ministernotomy provides a faster recovery with improved quality of life and satisfaction at 1 month compared to full sternotomy.",2020,"Patient satisfaction was also better at 1 month (Satiscore 83 ±9 vs 77± 13 points; p = 0,010).","['One hundred patients', 'patients with isolated severe aortic stenosis scheduled for elective aortic valve replacement']","['ministernotomy', 'ministernotomy versus full sternotomy aortic valve replacement']","['Patient satisfaction', 'baseline quality of life Questionnaire EuroQOL-index (EQ-5D-5L®', 'EQ-5D-index', 'quality of life and satisfaction', 'Quality of life and patient satisfaction', 'Quality of life', 'baseline EQ-5D-5L® utilities, cardiac surgery specific satisfaction questionnaire (SATISCORE®), a combined safety endpoint of four major adverse complications at 1 month (all-cause mortality, acute myocardial infarction, neurologic events and acute renal failure), bleeding through drains within the first 24 h, intubation time, and other minor endpoints', 'bleeding']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",100.0,0.311003,"Patient satisfaction was also better at 1 month (Satiscore 83 ±9 vs 77± 13 points; p = 0,010).","[{'ForeName': 'Emiliano A', 'Initials': 'EA', 'LastName': 'Rodríguez-Caulo', 'Affiliation': 'UGC Heart Area, Cardiovascular Surgery Department, Hospital Universitario Virgen de la Victoria de Málaga, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga, CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain. Electronic address: erodriguezcaulo@hotmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Guijarro-Contreras', 'Affiliation': 'UGC Heart Area, Cardiology Department, Hospital Universitario Virgen de la Victoria de Málaga, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga, CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Arantza', 'Initials': 'A', 'LastName': 'Guzón', 'Affiliation': 'UGC Heart Area, Cardiovascular Surgery Department, Hospital Universitario Virgen de la Victoria de Málaga, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga, CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Otero-Forero', 'Affiliation': 'UGC Heart Area, Cardiovascular Surgery Department, Hospital Universitario Virgen de la Victoria de Málaga, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga, CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Mataró', 'Affiliation': 'UGC Heart Area, Cardiovascular Surgery Department, Hospital Universitario Virgen de la Victoria de Málaga, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga, CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Sánchez-Espín', 'Affiliation': 'UGC Heart Area, Cardiovascular Surgery Department, Hospital Universitario Virgen de la Victoria de Málaga, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga, CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Porras', 'Affiliation': 'UGC Heart Area, Cardiovascular Surgery Department, Hospital Universitario Virgen de la Victoria de Málaga, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga, CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Villaescusa', 'Affiliation': 'UGC Heart Area, Cardiovascular Surgery Department, Hospital Universitario Virgen de la Victoria de Málaga, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga, CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Melero-Tejedor', 'Affiliation': 'UGC Heart Area, Cardiovascular Surgery Department, Hospital Universitario Virgen de la Victoria de Málaga, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga, CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Jiménez-Navarro', 'Affiliation': 'UGC Heart Area, Cardiology Department, Hospital Universitario Virgen de la Victoria de Málaga, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), University of Málaga, CIBERCV Enfermedades Cardiovasculares, Instituto de Salud Carlos III, Madrid, Spain.'}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2020.07.013']
1752,32853821,Psychometric Properties of the Asthma Symptom Index in Patients with Severe Asthma.,"BACKGROUND


Evaluation of symptoms is essential in asthma clinical research. Daily symptom diaries require once- or twice-daily recording, making them less suited to real-world use. A modified version of the established Asthma Symptom Utility Index (ASUI) that includes symptom attributes (Asthma Symptom Index [ASI]) was developed as a less-burdensome measure of asthma symptoms.
OBJECTIVE


To evaluate the ASI and replicate ASUI psychometric properties, including validity, reliability, responsiveness, and minimal clinically important difference (MCID) estimation in patients ≥12 years of age with severe asthma.
METHODS


Patients from a randomized trial (MUSCA [n = 497]) and a cross-sectional study (IDEAL [n = 721]) were analyzed post hoc. Demographic information, spirometry, ASI and ASUI scores, and other patient-reported outcome measures such as Asthma Control Questionnaire (ACQ-5) and St George's Respiratory Questionnaire (SGRQ) at baseline and during follow-up (MUSCA only) were obtained.
RESULTS


Internal consistency reliability and test-retest reliability were considered good (>0.70 [Cronbach's alpha] and 0.87-0.90 [intraclass correlation]). ASI/ASUI scores correlated strongly with ACQ-5 and SGRQ scores (spearman correlation [r s ] magnitude: 0.67-0.85). ASI and ASUI scores differed for asthma control (defined by ACQ-5) and lung function (% predicted forced expiratory volume in 1 second). Changes in ASI and ASUI scores from baseline to week 4 and week 12 had high correlations with changes in ACQ-5 (r s  magnitude: 0.57-0.69). MCIDs ranged from -0.42 to -0.26 (ASI) and 0.07 to 0.11 (ASUI).
CONCLUSION


Findings show the good reliability, validity, and responsiveness of the ASI, indicating potential value for real-world symptom assessment in severe asthma.",2020,ASUI scores correlated strongly with ACQ-5 and SGRQ scores (spearman correlation,"['patients with severe asthma', 'Patients from a randomized trial (MUSCA [n=497]) and a cross-sectional study (IDEAL [n=721', 'patients ≥12 years of age with severe asthma']",['ACQ-5'],"[""Demographic information, spirometry, ASI and ASUI scores, and other patient-reported outcome measures such as Asthma Control Questionnaire (ACQ-5) and St George's Respiratory Questionnaire (SGRQ"", 'Changes in ASI and ASUI score', 'lung function', 'Internal consistency reliability and test-retest reliability', 'ASI and ASUI scores', 'ACQ-5 and SGRQ scores (spearman correlation', 'ASUI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0323065', 'cui_str': 'Musca'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.0328296,ASUI scores correlated strongly with ACQ-5 and SGRQ scores (spearman correlation,"[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Value Evidence and Outcomes, GSK, Collegeville, Pa.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'von Maltzahn', 'Affiliation': 'Value Evidence and Outcomes, GSK, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Nelsen', 'Affiliation': 'Value Evidence and Outcomes, GSK, Collegeville, Pa.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Revicki', 'Affiliation': 'Revicki Outcomes Research Consulting, Sarasota, Fla. Electronic address: dennis.revicki@gmail.com.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.08.019']
1753,32856073,Follicular flushing leads to higher oocyte yield in monofollicular IVF: a randomized controlled trial.,"STUDY QUESTION


Does follicular flushing increase the number of mature oocytes in monofollicular IVF?
SUMMARY ANSWER


Follicular flushing increases the number of mature oocytes in monofollicular IVF.
WHAT IS KNOWN ALREADY


Flushing increases neither the oocyte yield nor the pregnancy rate in polyfollicular IVF or in poor responder patients. In monofollicular IVF, the effect of flushing has so far been addressed by two studies: (i) a prospective study with minimal stimulation IVF demonstrated an increased oocyte yield, and (ii) a retrospective study with natural cycle (NC)-IVF showed an increased oocyte yield and an increased transfer rate.
STUDY DESIGN, SIZE, DURATION


Randomized controlled trial including 164 women who were randomized for either aspiration with or without flushing from 2016 to 2019.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Infertile women 18-42 years of age with an indication for IVF treatment at a university-based infertility unit. Women undergoing monofollicular IVF were randomized to either follicular aspiration only or follicular aspiration directly followed by five follicular flushes at a 1:1 ratio. The intervention was done without anaesthesia, using a gauge 19 single-lumen needle. Flushing volume was calculated (sphere formula) based on the size of the follicle.
MAIN RESULTS AND THE ROLE OF CHANCE


A total of 164 women were included; 81 were allocated to 'aspiration only' and 83 to additional 'flushing'. Primary analysis was based on the intention-to-treat: oocyte yield, defined as the collected mature oocyte rate, was higher (n = 64/83, 77.1%) in the flushing group compared to the aspiration only group (n = 48/81, 59.3%, adjusted risk difference (RD): 18.2% (95% CI 3.9-31.7%), P-value = 0.02). In the flushing group, most oocytes were retrieved within the first three flushes (63/83, 75.8%). Fertilization rate was higher in the flushing group (n = 53/83, 63.9% vs n = 38/81, 46.9%; adjusted RD: 16.8% (96% CI 1.5-31.4%), P = 0.045). Transfer rate was also higher in the flushing group (n = 52/83, 62.7% vs n = 38/81, 46.9%; RD: 15.71 (95% CI 0.3-30.3%)), but the difference was not significant (P = 0.06). The clinical pregnancy rate n = 9/83 versus n = 9/81 (RD: -0.3% (95% CI -9.9% to 9.5%)) and live birth rate n = 7/83 versus n = 8/81 (RD: -1.5% (95% CI -10.4% to 7.1%)) were not significantly different between the flushing and the aspiration group. The median duration of the intervention was significantly longer with flushing (2.38 min; quartiles 2.0, 2.7) versus aspiration only (0.43 min; quartiles 0.3, 0.5) (P < 0.01). There was no significant difference in the mean (±SD) visual analogue scales pain score between the follicular flushing (3.4 ± 1.8) and the aspiration group (3.1 ± 1.89).
LIMITATIONS, REASONS FOR CAUTION


Blinding of the procedure was not possible.
WIDER IMPLICATIONS OF THE FINDINGS


Our study proved that flushing of single follicles in NC-IVF increases the oocyte yield. In contrast to polyfollicular IVF flushing seems to be beneficial in a monofollicular setting if the technique used in our study (single-lumen needle, 5 flushings with flushing volume adaptation) is applied.
STUDY FUNDING/COMPETING INTEREST(S)


The study was funded by the financial sources of the division and in part by a research grant provided by NMS Biomedical SA, Switzerland. The company did not have any roles in design or conduct of the study or in the preparation of the manuscript. The authors have no other conflicts of interest.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov NCT02641808.
TRIAL REGISTRATION DATE


29 December 2015.
DATE OF FIRST PATIENT’S ENROLMENT


22 August 2016.",2020,"There was no significant difference in the mean (±SD) visual analogue scales pain score between the follicular flushing (3.4 ± 1.8) and the aspiration group (3.1 ± 1.89).
","['n\u2009=\u20099/83 versus n\u2009=\u20099/81 (RD', '29 December 2015', ""A total of 164 women were included; 81 were allocated to 'aspiration only' and 83 to additional 'flushing"", '164 women who were randomized for either aspiration with or without flushing from 2016 to 2019', 'Women undergoing monofollicular IVF', 'Infertile women 18-42 years of age with an indication for IVF treatment at a university-based infertility unit', '’S ENROLMENT\n\n\n22 August 2016', '\u20098/81 (RD']",['follicular aspiration only or follicular aspiration directly followed by five follicular flushes'],"['Fertilization rate', 'Transfer rate', 'clinical pregnancy rate', 'median duration of the intervention', 'Flushing volume', 'live birth rate', 'intention-to-treat: oocyte yield, defined as the collected mature oocyte rate', 'mean (±SD) visual analogue scales pain score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",164.0,0.16421,"There was no significant difference in the mean (±SD) visual analogue scales pain score between the follicular flushing (3.4 ± 1.8) and the aspiration group (3.1 ± 1.89).
","[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Kohl Schwartz', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Calzaferri', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roumet', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Limacher', 'Affiliation': 'CTU Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fink', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wueest', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Weidlinger', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'V R', 'Initials': 'VR', 'LastName': 'Mitter', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Leeners', 'Affiliation': 'Department of Reproductive Endocrinology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Von Wolff', 'Affiliation': 'Division of Gynecological Endocrinology and Reproductive Medicine, Bern University Hospital, University of Bern, Inselspital, 3010 Bern, Switzerland.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa165']
1754,32826188,How periarticular corticosteroid injections impact the integrity of arthroscopic rotator cuff repair.,"INTRODUCTION


Multimodal analgesic (MMA) injections combined with corticosteroids have recently been shown to be effective for managing pain after arthroscopic rotator cuff repair.
HYPOTHESIS


The goal of this study was to analyze the effects of corticosteroid injections on the integrity of tendon repairs using magnetic resonance imaging (MRI). The hypothesis was that MMA injections combined with corticosteroids have no deleterious effects on functional outcomes and tendon healing 1 year after surgical rotator cuff repair.
METHODS


This was a prospective, double-blind study of 50 patients undergoing arthroscopic rotator cuff repair who were randomized into two groups. The study group (n=25) received a periarticular injection of a mixture of ropivacaine, morphine and methylprednisolone at the end of the procedure. The control group (n=25) received a placebo injection. The clinical outcomes were the pain level and complications, while the functional outcomes consisted of the Constant-Murley Score (CMS), American Shoulder and Elbow Surgeons Shoulder (ASES) score and Simple Shoulder Test (SST). The structural integrity of the operated tendons was analyzed on MRI at a mean follow-up of 15.1±1.3 months for the study group and 15.2±1.1 for the control group (p=0.848).
RESULTS


Pain on a visual analog scale was significantly reduced in both groups after the surgery. Nevertheless, there was no significant difference between groups at the final follow-up visit (p=0.803). Compared to the preoperative values, the CMS, ASES and SST significantly improved in both groups after surgery but were not significantly different between groups at the final assessment (p=0.801, 0.869 and 0.769, respectively). MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107). There were no infections in the study group as of the final assessment. Advanced age (p=0.049), diabetes (p<0.01) and posterior extension of the tear (p=0.039) negatively impact healing. Corticosteroid injection did not negatively impact healing (p=0.197).
CONCLUSION


This study shows that MMA injection combined with corticosteroids does not alter the tendon healing, clinical outcomes, or functional outcomes 1 year after arthroscopic rotator cuff repair. It remains a safe and effective analgesia method during rotator cuff repair surgery.
LEVEL OF EVIDENCE


II, low-powered placebo-controlled, randomized study.",2020,MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107).,"['50 patients undergoing arthroscopic rotator cuff repair', 'arthroscopic rotator cuff repair']","['periarticular injection of a mixture of ropivacaine, morphine and methylprednisolone', 'Corticosteroid injection', 'MMA injections combined with corticosteroids', 'placebo injection', 'Multimodal analgesic (MMA) injections combined with corticosteroids', 'magnetic resonance imaging (MRI', 'corticosteroid injections', 'MMA injection combined with corticosteroids']","['CMS, ASES and SST', 'pain level and complications, while the functional outcomes consisted of the Constant-Murley Score (CMS), American Shoulder and Elbow Surgeons Shoulder (ASES) score and Simple Shoulder Test (SST', 'visual analog scale', 'supraspinatus tendon retears']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]",50.0,0.151985,MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107).,"[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Perdreau', 'Affiliation': ""Orthopedic and Trauma Surgery Department, Centre Hospitalier de l'Ardenne, 35, Avenue de Houffalize 35, 6800 Libramont-Chevigny, Belgium. Electronic address: perdreaua@hotmail.com.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Duysens', 'Affiliation': 'Institut Européen de la main, Centre Hospitalier du Kirchberg, 9, Rue Edward Steichen, 2540 Luxembourg, Grand Duchy of Luxembourg, Luxembourg.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Joudet', 'Affiliation': 'Orthopedic Surgery Department, Clinique Chirurgicale du Libournais, 119, Rue de la Marne, 33500 Libourne, France.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.05.009']
1755,32827348,"Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression.","AIM


Previous studies conducted primarily in the USA and Europe have demonstrated the efficacy and safety of lurasidone 20-120 mg/day for the treatment of bipolar I depression. The aim of the current study was to evaluate the efficacy and safety of lurasidone monotherapy for the treatment of bipolar I depression among patients from diverse ethnic backgrounds, including those from Japan.
METHODS


Patients were randomly assigned to double-blind treatment for 6 weeks with lurasidone, 20-60 mg/day (n = 184) or 80-120 mg/day (n = 169), or placebo (n = 172). The primary end-point was change from baseline to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS).
RESULTS


Lurasidone treatment significantly reduced mean MADRS total scores from baseline to Week 6 for the 20-60-mg/day group (-13.6; adjusted P = 0.007; effect size = 0.33), but not for the 80-120-mg/day group (-12.6; adjusted P = 0.057; effect size = 0.22) compared with placebo (-10.6). Treatment with lurasidone 20-60 mg/day also improved MADRS response rates, functional impairment, and anxiety symptoms. The most common adverse events associated with lurasidone were akathisia and nausea. Lurasidone treatments were associated with minimal changes in weight, lipids, and measures of glycemic control.
CONCLUSION


Monotherapy with once daily doses of lurasidone 20-60 mg, but not 80-120 mg, significantly reduced depressive symptoms and improved functioning in patients with bipolar I depression. Results overall were consistent with previous studies, suggesting that lurasidone 20-60 mg/day is effective and safe in diverse ethnic populations, including Japanese.",2020,"RESULTS


Lurasidone treatment significantly reduced mean MADRS total scores from baseline to week 6 for the 20-60 mg/day group (-13.6; adjusted p = 0.007; effect size = 0.33), but not for the 80-120 mg/day group (-12.6; adjusted p = 0.057; effect size = 0.22) compared with placebo (-10.6).","['patients with bipolar I depression', 'bipolar I depression among patients from diverse ethnic backgrounds including those from Japan', 'Patients']","['lurasidone', 'Placebo', 'Monotherapy', 'lurasidone monotherapy', 'Lurasidone Monotherapy', 'placebo']","['Montgomery Åsberg Depression Rating Scale (MADRS', 'depressive symptoms', 'weight or metabolic parameters', 'efficacy and safety', 'akathisia and nausea', 'mean MADRS total scores', 'MADRS response rates, functional impairment, and anxiety symptoms', 'body weight, lipids, and measures of glycemic control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.15438,"RESULTS


Lurasidone treatment significantly reduced mean MADRS total scores from baseline to week 6 for the 20-60 mg/day group (-13.6; adjusted p = 0.007; effect size = 0.33), but not for the 80-120 mg/day group (-12.6; adjusted p = 0.057; effect size = 0.22) compared with placebo (-10.6).","[{'ForeName': 'Tadafumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Psychiatry, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ishigooka', 'Affiliation': 'Institute of CNS Pharmacology, Tokyo, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Miyajima', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Watabe', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Fujimori', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Masuda', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Japan Depression Center, Tokyo, Japan.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Bipolar and Depressive Disorders Unit, Hospital Clinic, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13137']
1756,32822216,Hormetic modulation of angiogenic factors by exercise-induced mechanical and metabolic stress in human skeletal muscle.,"This study used an integrative experimental model in humans to investigate whether muscle angiogenic factors are differentially modulated by exercise stimuli eliciting different degrees of mechanical and metabolic stress. In a randomized crossover design, 12 men performed two low-volume high-intensity exercise regimens, including short sprint intervals (SSI) or long sprint intervals (LSI) inducing pronounced mechanical/metabolic stress, and a high-volume moderate-intensity continuous exercise protocol (MIC) inducing mild but prolonged mechanical/metabolic stress. Gene and protein expression of angiogenic factors was determined in vastus lateralis muscle samples obtained before and after exercise. Exercise upregulated muscle  VEGF  mRNA to a greater extent in LSI and MIC compared with SSI. Analysis of angiogenic factors sensitive to shear stress revealed more marked exercise-induced VEGF receptor 2 ( VEGF-R2 ) mRNA responses in MIC than SSI, as well as greater platelet endothelial cell adhesion molecule ( PECAM-1 ) and endothelial nitric oxide synthase ( eNOS ) mRNA responses in LSI than SSI. No apparent exercise-induced phosphorylation of shear stress-sensory proteins VEGF-R2 Tyr1175 , PECAM-1 Tyr713 , and eNOS Ser1177  was observed despite robust elevations in femoral artery shear stress. Exercise evoked greater mRNA responses of the mechanical stretch sensor matrix metalloproteinase-9 ( MMP9 ) in SSI than MIC. Exercise-induced mRNA responses of the metabolic stress sensor hypoxia-inducible factor-1α ( HIF-1α ) were more profound in LSI than SSI. These results suggest that low-volume high-intensity exercise transcriptionally activates angiogenic factors in a mechanical/metabolic stress-dependent manner. Furthermore, the angiogenic potency of low-volume high-intensity exercise appears similar to that of high-volume moderate-intensity exercise, but only on condition of eliciting severe mechanical/metabolic stress. We conclude that the angiogenic stimulus produced by exercise depends on both magnitude and protraction of myocellular homeostatic perturbations. NEW & NOTEWORTHY  Skeletal muscle capillary growth is orchestrated by angiogenic factors sensitive to mechanical and metabolic signals. In this study, we employed an integrative exercise model to synergistically target, yet to different extents and for different durations, the mechanical and metabolic components of muscle activity that promote angiogenesis. Our results suggest that the magnitude of the myocellular perturbations incurred during exercise determines the amplitude of the angiogenic molecular signals, implying hormetic modulation of skeletal muscle angiogenesis by exercise-induced mechanical and metabolic stress.",2020,Exercise‑induced mRNA responses of the metabolic stress sensor HIF‑1α were more profound in LSI than SSI.,"['twelve men performed two', 'human skeletal muscle']","['low‑volume high-intensity exercise regimens, including short sprint intervals (SSI) or long sprint intervals (LSI) inducing pronounced mechanical/metabolic stress, and a high‑volume moderate‑intensity continuous exercise protocol (MIC']",['Gene and protein expression of angioregulatory factors'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C2350024', 'cui_str': 'Metabolic Stress'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",12.0,0.0206168,Exercise‑induced mRNA responses of the metabolic stress sensor HIF‑1α were more profound in LSI than SSI.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fiorenza', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gliemann', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Brandt', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'Section of Integrative Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00432.2020']
1757,32822827,A community-based asthma program: Study design and methods of RVA Breathes.,"Disparities in pediatric asthma morbidity and healthcare utilization exist on the basis of race, ethnicity, environment, and income; interventions are needed to address these inequities. The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors. Community stakeholder feedback was utilized to refine the intervention specifically for the Richmond, Virginia community. The aims of this study are to assess the effect of RVA Breathes on asthma-related healthcare utilization, as well as secondary outcomes of asthma control, asthma symptoms, and quality of life. We will enroll 300 elementary school children from the Richmond City Public School system. Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years. Participants will be randomized to one of three groups: asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition. Data will be collected across one baseline research visit, four intervention sessions, and four follow-up research visits over the course of 18 months. A General Linear Mixed Model (GLMM) will be used to test primary aims. We expect the findings will provide support for coordination of asthma care across sectors. Further, we hope RVA Breathes will serve as a model of community-based pediatric asthma care.",2020,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","['Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years', '300 elementary school children from the Richmond City Public School system']","['asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition', 'RVA']","['asthma control, asthma symptoms, and quality of life']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",300.0,0.0360733,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","[{'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Everhart', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America. Electronic address: reverhart@vcu.edu.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Corona', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Holder', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Leroy R', 'Initials': 'LR', 'LastName': 'Thacker', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Schechter', 'Affiliation': ""Children's Hospital of Richmond at VCU, Richmond, VA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106121']
1758,32822968,"Improvement in overall survival with Apalutamide, Darolutamide and Enzalutamide in patients with non-metastatic castration-resistant prostate cancer.","Since 2018, apalutamide, darolutamide, and enzalutamide have been approved for the treatment of men with non-metastatic castration-resistant prostate cancer (M0CRPC). These approvals were based on the results of three separate randomized, placebo-controlled, phase III trials: SPARTAN (apalutamide), ARAMIS (darolutamide) and PROSPER (enzalutamide). These trials included men with M0CRPC and a short PSA doubling time (≤10 months). Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone. Updated results of these trials presented in the 2020 annual meeting of American Society of Oncology (ASCO) showed significantly improved overall survival with these agents. Based on these results, apalutamide, darolutamide, and enzalutamide can now be considered the standard of care treatment options for the treatment of men with M0CRPC.",2020,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","['men with M0CRPC and a short PSA doubling time (≤10 months', 'men with non-metastatic castration-resistant prostate cancer (M0CRPC', 'men with M0CRPC', 'patients with non-metastatic castration-resistant prostate cancer']","['Apalutamide, Darolutamide and Enzalutamide', 'ARAMIS (darolutamide) and PROSPER (enzalutamide', 'androgen deprivation therapy (ADT', 'placebo']","['overall survival', 'longer metastasis-free survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0449496,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","[{'ForeName': 'Umang', 'Initials': 'U', 'LastName': 'Swami', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Electronic address: umang.swami@hci.utah.edu.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100205']
1759,32827501,Intranasal vasopressin expedites dishonesty in women.,"As an integral ingredient of human sociality, dishonesty can be both egocentric and altruistic, as well as gradually escalate. Here, we examined the influence of arginine vasopressin (AVP), a neuropeptide associated with human prosocial behaviors, on dishonest behaviors in men and women. In this double-blind and placebo-controlled study, 101 participants were randomized to administration of either 20 IU intranasal AVP or placebo. We used a two-party task to manipulate the incentive structure of dishonesty in the way of self-/other-serving repeatedly. For lies that benefit both themselves and others, women receiving intranasal AVP lied more than women receiving intranasal placebo and men receiving intranasal AVP. The dishonest behavior of women treated with AVP gradually escalated with repetition over time. These results suggest that AVP selectively regulates the escalation of dishonesty in women, contingent on the motivation of dishonesty. Our findings provide insight into gender-specific modulations of AVP on human dishonest behavior.",2020,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","['females', '101 participants', 'males and females']","['Intranasal vasopressin', 'intranasal AVP', 'AVP', 'intranasal placebo', '20\u202fIU intranasal AVP or placebo', 'arginine vasopressin (AVP', 'placebo']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],101.0,0.145508,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application, Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yuejia', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Beijing Key Laboratory of Applied Experimental Psychology, Faculty of Psychology, Beijing Normal University, Beijing, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China; Great Bay Neuroscience and Technology Research Institute (Hong Kong), Kwun Tong, Hong Kong, China. Electronic address: xupf@szu.edu.cn.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104843']
1760,32828187,"The Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials in Mozambique, Pakistan, and India: an individual participant-level meta-analysis.","BACKGROUND


To overcome the three delays in triage, transport and treatment that underlie adverse pregnancy outcomes, we aimed to reduce all-cause adverse outcomes with community-level interventions targeting women with pregnancy hypertension in three low-income countries.
METHODS


In this individual participant-level meta-analysis, we de-identified and pooled data from the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trials in Mozambique, Pakistan, and India, which were run in 2014-17. Consenting pregnant women, aged 12-49 years, were recruited in their homes. Clusters, defined by local administrative units, were randomly assigned (1:1) to intervention or control groups. The control groups continued local standard of care. The intervention comprised community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension. For this meta-analysis, as for the original studies, the primary outcome was a composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby), assessed by unmasked trial surveillance personnel. For this analysis, we included all consenting participants who were followed up with completed pregnancies at trial end. We analysed the outcome data with multilevel modelling and present data with the summary statistic of adjusted odds ratios (ORs) with 95% CIs (fixed effects for maternal age, parity, maternal education, and random effects for country and cluster). This meta-analysis is registered with PROSPERO, CRD42018102564.
FINDINGS


Overall, 44 clusters (69 330 pregnant women) were randomly assigned to intervention (22 clusters [36 008 pregnancies]) or control (22 clusters [33 322 pregnancies]) groups. 32 290 (89·7%) pregnancies in the intervention group and 29 698 (89·1%) in the control group were followed up successfully. Median maternal age of included women was 26 years (IQR 22-30). In the intervention clusters, 6990 group and 16 691 home-based community engagement sessions and 138 347 community health worker-led visits to 20 819 (57·8%) of 36 008 women (of whom 11 095 [53·3%] had a visit every 4 weeks) occurred. Blood pressure and dipstick proteinuria were assessed per protocol. Few women were eligible for methyldopa for severe hypertension (181 [1%] of 20 819) or intramuscular magnesium sulfate for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia). 1255 (6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral. The primary outcome was similar in the intervention (7871 [24%] of 32 290 pregnancies) and control clusters (6516 [22%] of 29 698; adjusted OR 1·17, 95% CI 0·90-1·51; p=0·24). No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility.
INTERPRETATION


The CLIP intervention did not reduce adverse pregnancy outcomes. Future community-level interventions should expand the community health worker workforce, assess general (rather than condition-specific) messaging, and include health system strengthening.
FUNDING


University of British Columbia, a grantee of the Bill & Melinda Gates Foundation.",2020,"No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility.
","['6990 group and 16\u2008691 home-based community engagement sessions and 138\u2008347 community health worker-led visits to 20\u2008819 (57·8%) of 36\u2008008 women (of whom 11\u2008095', 'for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia', '1255', '44 clusters (69\u2008330 pregnant women', 'consenting participants who were followed up with completed pregnancies at trial end', '6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral', 'Median maternal age of included women was 26 years (IQR 22-30', 'women with pregnancy hypertension in three low-income countries', 'Consenting pregnant women, aged 12-49 years, were recruited in their homes']","['intramuscular magnesium sulfate', 'community-level interventions targeting', 'community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension', 'magnesium sulfate', 'CLIP intervention', 'methyldopa']","['composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby', 'adverse pregnancy outcomes', 'adverse effects', 'Blood pressure and dipstick proteinuria', 'control clusters', 'severe hypertension', 'serious adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019982', 'cui_str': 'Referral to hospital'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",69330.0,0.274918,"No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada. Electronic address: pvd@kcl.ac.uk.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, Toronto, ON, Canada; Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': 'Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Mrutyunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': 'KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': 'KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, Hanagal Shree Kumareshwar Hospital and Research Centre, Bagalkote, Karnataka, India.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça, Manhiça, Mozambique; Department of Physiological Sciences, Clinical Pharmacology, Faculdade de Medicina, Universidade Eduardo Mondlane, Maputo, Mozambique.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça, Manhiça, Mozambique.'}, {'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Physiological Sciences, Clinical Pharmacology, Faculdade de Medicina, Universidade Eduardo Mondlane, Maputo, Mozambique.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31128-4']
1761,32829105,Determination of the UGT1A1 polymorphism as guidance for irinotecan dose escalation in metastatic colorectal cancer treated with first-line bevacizumab and FOLFIRI (PURE FIST).,"AIM


Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism plays a crucial role in the increased susceptibility of patients to irinotecan and its toxicity. This study is a multicenter, randomised clinical trial comparing the clinical outcomes and adverse events (AEs) in metastatic colorectal cancer (mCRC) patients treated with bevacizumab plus FOLFIRI with or without UGT1A1 genotyping and irinotecan dose escalation as the first-line therapy.
METHODS


The control group received conventional biweekly FOLFIRI plus bevacizumab without UGT1A1 genotyping, whereas the study group received the same regimen with irinotecan dose escalation based on UGT1A1 genotyping. The primary end-point was progression-free survival (PFS), and secondary end-points were overall response rate (ORR), disease control rate (DCR), overall survival (OS), AEs and metastasectomy rate.
RESULTS


Over a median follow-up of 26.0 months (IQR, 17.0-35.0 months), study group (n = 107) was superior to the control group (n = 106) in PFS, OS, ORR, DCR, and metastasectomy rate (all P < 0.05). Furthermore, there were no significant differences in AEs ≥ grade III between the two groups, even with the 1.36-fold increase in the relative dose intensity of irinotecan in the study group. Dose escalation of irinotecan, an independent factor of ORR (P < 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
CONCLUSION


The current study revealed that mCRC patients, regardless of KRAS gene status, with UGT1A1 genotyping can tolerate escalated doses of irinotecan and potentially achieve a more favourable clinical outcome without significantly increased toxicities.
CLINICAL TRIAL REGISTRATION


NCT02256800.",2020,"< 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
","['metastatic colorectal cancer (mCRC) patients treated with', 'metastatic colorectal cancer treated with first-line']","['bevacizumab plus FOLFIRI with or without UGT1A1 genotyping and irinotecan', 'bevacizumab and FOLFIRI (PURE FIST', 'conventional biweekly FOLFIRI plus bevacizumab', 'irinotecan dose escalation based on UGT1A1 genotyping', 'irinotecan']","['DCR', 'progression-free survival (PFS), and secondary end-points were overall response rate (ORR), disease control rate (DCR), overall survival (OS), AEs and metastasectomy rate', 'PFS', 'PFS, OS, ORR, DCR, and metastasectomy rate', 'toxicities']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0041986', 'cui_str': 'Uridine diphosphate'}, {'cui': 'C0041560', 'cui_str': 'Glucuronosyltransferase'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0336667', 'cui_str': 'Fist'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0452964,"< 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
","[{'ForeName': 'Hsiang-Lin', 'Initials': 'HL', 'LastName': 'Tsai', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: chunpin870132@yahoo.com.tw.'}, {'ForeName': 'Ching-Wen', 'Initials': 'CW', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: baseball5824@yahoo.com.tw.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Lin', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Tainan Municipal Hospital, Tainan, Taiwan. Electronic address: linyiewen@yahoo.com.tw.'}, {'ForeName': 'Jui-Ho', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. Electronic address: rayhowang@gmail.com.'}, {'ForeName': 'Chang-Chieh', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Keelung Branch, Tri-Service General Hospital, Keelung, Taiwan. Electronic address: doc20276@gmail.com.'}, {'ForeName': 'Yung-Chuan', 'Initials': 'YC', 'LastName': 'Sung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Taipei Cathay General Hospital, Taipei, Taiwan. Electronic address: yungchuans@cgh.org.tw.'}, {'ForeName': 'Tzu-Liang', 'Initials': 'TL', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: golfma22@gmail.com.'}, {'ForeName': 'Hwei-Ming', 'Initials': 'HM', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: phillipwhm@gmail.com.'}, {'ForeName': 'Hsiu-Chin', 'Initials': 'HC', 'LastName': 'Tang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Tainan Sin-Lan Hospital, Tainan, Taiwan. Electronic address: schoetz.tang@gmail.com.'}, {'ForeName': 'Joe-Bin', 'Initials': 'JB', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung Veterans General Hospital, Taichung, Taiwan. Electronic address: jbchen@vghtc.gov.tw.'}, {'ForeName': 'Tao-Wei', 'Initials': 'TW', 'LastName': 'Ke', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: ketaowei@gmail.com.'}, {'ForeName': 'Chang-Sung', 'Initials': 'CS', 'LastName': 'Tsai', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Tainan Municipal Hospital, Tainan, Taiwan. Electronic address: chonsonechai@gmail.com.'}, {'ForeName': 'Hsuan-Yuan', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Changhua Christian Hospital, Changhua, Taiwan. Electronic address: 107431@cch.org.tw.'}, {'ForeName': 'Jaw-Yuan', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: cy614112@ms14.hinet.net.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.031']
1762,32829109,High- and moderate-intensity training modify LPS-induced ex-vivo interleukin-10 production in obese men in response to an acute exercise bout.,"The aim of this study was to evaluate the inflammatory (peripheral and lipopolysaccharide (LPS)-stimulated released from whole blood) and metabolic (glucose and insulin) profile of inactive obese men in response to two isoenergetic models of aerobic exercise training (~300  kcal each exercise session). Twenty-two participants (28.7 ± 1.6 years; BMI = 34.4 ± 0.1 kg/m 2 ) were randomized into two groups: I) HIIT: high-intensity interval training (10× 1 bout: 1 min - 100% Maximal Aerobic Velocity) or II) MICT: moderate-intensity continuous training (65% Maximal Aerobic Velocity; kcal equal to HIIT). Both groups trained three times per week for 6-weeks. Fasting blood samples were collected before and 0, 30, and 60 min after exercise during the first and last training sessions for evaluation of: I) MIP-1ɑ, insulin, glucose, visceral and subcutaneous fat depots, oral glucose tolerance test, and homeostatic model assessment of insulin resistance (HOMA-IR) index; II) Peripheral (TNF-α, IL-6, and IL-10) and LPS-stimulated release of TNF-α and IL-10 were analyzed before, 0, and 60 min after sessions. IL-6 concentration remained elevated up to 60-min after the acute exercise session (p < 0.001), and IL-10 concentration was higher after 30 and 60-min (p = 0.001) compared to rest, independent of training period and protocol. AUC of IL-10 presented effect of type of training (p = 0.023) with MICT group showed significantly higher values than the HIIT. The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period. Fifteen subjects presented decreased HOMA-IR after 6-weeks and seven presented an increase in this index. When we excluded the two least responsive subjects, it was possible to observe a decrease in HOMA-IR (p = 0.020) after training. Taken together, our results suggest that both HIIT and MICT (with same energy expenditure) promote similar effects on HOMA-IR and led to elevations in IL-10 production in LPS-stimulated whole blood, suggesting that leukocytes had an enhanced ability to secrete anti-inflammatory cytokines after the exercise bout.",2020,"The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period.","['Twenty-two participants (28.7\xa0±\xa01.6\xa0years; BMI\xa0=\xa034.4\xa0±\xa00.1\xa0kg/m 2 ', 'obese men in response to an acute exercise bout', 'inactive obese men']","['MICT', 'HIIT and MICT', 'IL-6', 'inflammatory (peripheral and lipopolysaccharide (LPS)-stimulated released from whole blood) and metabolic (glucose and insulin', 'HIIT: high-intensity interval training (10× 1 bout: 1\xa0min - 100% Maximal Aerobic Velocity) or II) MICT: moderate-intensity continuous training (65% Maximal Aerobic Velocity; kcal equal to HIIT', 'aerobic exercise training', 'High- and moderate-intensity training modify LPS-induced ex-vivo interleukin-10 production']","['MIP-1ɑ, insulin, glucose, visceral and subcutaneous fat depots, oral glucose tolerance test, and homeostatic model assessment of insulin resistance (HOMA-IR) index; II) Peripheral (TNF-α, IL-6, and IL-10) and LPS-stimulated release of TNF-α and IL-10', 'HOMA-IR', 'Fasting blood samples', 'IL-10 secretion', 'concentration', 'IL-10 concentration']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]","[{'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0237388,"The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gerosa-Neto', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil; Physical Education, Physiotherapy, University Center of Maringa (UniCesumar), Parana, Brazil.'}, {'ForeName': 'Paula Alves', 'Initials': 'PA', 'LastName': 'Monteiro', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Daniela Sayuri', 'Initials': 'DS', 'LastName': 'Inoue', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Barbara Moura', 'Initials': 'BM', 'LastName': 'Antunes', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Batatinha', 'Affiliation': 'Department of Cell and Developmental Biology, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Gilson Pires', 'Initials': 'GP', 'LastName': 'Dorneles', 'Affiliation': 'Department of Health Basic Science, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Peres', 'Affiliation': 'Department of Health Basic Science, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'José Cesar', 'Initials': 'JC', 'LastName': 'Rosa-Neto', 'Affiliation': 'Department of Cell and Developmental Biology, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil. Electronic address: fabio.lira@unesp.br.'}]",Cytokine,['10.1016/j.cyto.2020.155249']
1763,32829400,BCG vaccination in infancy does not protect against COVID-19. Evidence from a natural experiment in Sweden.,"BACKGROUND


The Bacille Calmette-Guérin (BCG) tuberculosis vaccine has immunity benefits against respiratory infections. Accordingly, it has been hypothesized to have a protective effect against COVID-19. Recent research found that countries with universal BCG childhood vaccination policies tend to be less affected by the COVID-19 pandemic. However, such ecological studies are biased by numerous confounders. Instead, this paper takes advantage of a rare nationwide natural experiment that took place in Sweden in 1975, where discontinuation of newborns BCG vaccination led to a dramatic fall of the BCG coverage rate, thus allowing us to estimate the BCG's effect without the biases associated with cross-country comparisons.
METHODS


Numbers of COVID-19 cases and hospitalizations were recorded for birth cohorts born just before and just after 1975, representing 1,026,304 and 1,018,544 individuals, respectively. We used regression discontinuity to assess the effect of BCG vaccination on Covid-19 related outcomes. This method used on such a large population allows for a high precision that would be hard to achieve using a randomized controlled trial.
RESULTS


The odds ratio for Covid-19 cases and Covid-19 related hospitalizations were 1·0005 (CI95: [0·8130-1·1881]) and 1·2046 (CI95: [0·7532-1·6560]), allowing us to reject fairly modest effects of universal BCG vaccination. We can reject with 95% confidence that universal BCG vaccination reduces the number of cases by 19% and the number of hospitalizations by 25%.
CONCLUSIONS


While the effect of a recent vaccination must be evaluated, we provide strong evidence that receiving the BCG vaccine at birth does not have a protective effect against COVID-19 among middle-aged individuals.",2020,"We can reject with 95% confidence that universal BCG vaccination reduces the number of cases by 19% and the number of hospitalizations by 25%.
","['Evidence from a natural experiment in Sweden', 'Numbers of COVID-19 cases and hospitalizations were recorded for birth cohorts born just before and just after 1975, representing 1,026,304 and 1,018,544 individuals, respectively', 'middle-aged individuals']",['universal BCG vaccination'],[],"[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",[],,0.165255,"We can reject with 95% confidence that universal BCG vaccination reduces the number of cases by 19% and the number of hospitalizations by 25%.
","[{'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'de Chaisemartin', 'Affiliation': 'Department of Economics, University of California, Santa Barbara, Santa Barbara, CA 93106, USA.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'de Chaisemartin', 'Affiliation': 'Immunology Department, APHP.Nord-Université de Paris, Bichat Hospital, Paris, France.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1223']
1764,32838647,Pharmacogenomics and pharmacokinetics of efavirenz 400 or 600 mg in 184 treatment-naive HIV-infected patients in China.,"Background:  The pharmacogenomics and pharmacokinetics/pharmacodynamics of 400 mg efavirenz have rarely been reported.  Materials & methods:  A total of 184 treatment-naive HIV-infected patients were randomly assigned (1:1) to receive a lower dose (tenofovir disoproxil 200 mg, efavirenz 400 mg and lamivudine) or a standard dose regimen. Relationships between pharmacogenomics and efavirenz pharmacokinetics/pharmacodynamics were explored at 48 weeks.  Results:  There was no relationship between pharmacogenomics and adverse reactions of the central nervous system and antiretoviral efficacy.  CYP2B6 516G>T ,  785A>G ,  18492C>T  and ABCB1  3435C>T  T/C were associated with higher efavirenz plasma levels in the standard but not the lower dose group. No relationship was found between pharmacogenomics and antiretoviral efficacy. Patients who were <60 kg had higher efavirenz concentration compared with those with weight ≥60 kg when using 600 mg efavirenz, this was not observed with 400 mg efavirenz.  Conclusion:  The effect of pharmacogenomics and body weight on the efavirenz concentration was significant in the 600 mg group but not in the 400 mg group.",2020,T  T/C were associated with higher efavirenz plasma levels in the standard but not the lower-dose group.,"['184 treatment-naive HIV-infected patients in China', 'A total of 184 treatment-naive HIV-infected patients']","['lower dose (tenofovir disoproxil 200\xa0mg, efavirenz 400\xa0mg and\xa0lamivudine', 'efavirenz']","['efavirenz plasma levels', 'T  and ABCB1  3435C', 'efavirenz concentration']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0963398', 'cui_str': 'tenofovir disoproxil'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4555930', 'cui_str': 'efavirenz 400 MG'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1738970', 'cui_str': 'ABCB1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0548373,T  T/C were associated with higher efavirenz plasma levels in the standard but not the lower-dose group.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Jingna', 'Initials': 'J', 'LastName': 'Xun', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Zhiliang', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Infectious Disease, The Second Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, 210003, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Yunnan AIDS Care Center (YNACC), Yunnan Provincial Infectious Disease Hospital, Kunming, 650500, China.'}, {'ForeName': 'Renfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Corky', 'Initials': 'C', 'LastName': 'Steinhart', 'Affiliation': 'CAN Community Health, FL 34232, USA.'}, {'ForeName': 'Yinzhong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}]",Pharmacogenomics,['10.2217/pgs-2019-0169']
1765,32835786,Attachment anxiety moderates the effect of oxytocin on negative emotion recognition: Evidence from eye-movement data.,"Valence-specific effects of oxytocin have been revealed in a selection of preceding studies, while others report that oxytocin could improve facial recognition, regardless of emotion valence. The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition. In this study, we used eye tracking to test whether attachment style moderates the effect of oxytocin on negative emotion recognition, which is crucial for social cognition. We employed a placebo-controlled, double-blind, within-participants design. The participants were 73 healthy individuals (41 men) who received a single dose of intranasal oxytocin (24 IU) on one occasion and a placebo dose on another occasion. Visual attention to the eye region was assessed on both occasions, through the completion of an emotion recognition task. Our results showed that oxytocin increased participants' eye gaze towards facial expressions. Among participants who received oxytocin, as opposed to a placebo, only individuals with high attachment anxiety displayed more eye gaze and less mouth gaze towards facial expression, regardless of emotion valence. Our findings confirmed that oxytocin increases gaze to the eye region, thus improving facial recognition, regardless of emotion valence, this relationship was moderated by attachment anxiety. Further, our results highlighted the importance of considering individual differences when evaluating the effects of oxytocin on emotion recognition.",2020,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.",['participants were 73 healthy individuals (41 men) who received a single dose of'],"['intranasal oxytocin', 'placebo', 'oxytocin']","['social behavior and cognition', 'eye gaze and less mouth gaze towards facial expression, regardless of emotion valence', 'emotion recognition', 'facial recognition, regardless of emotion valence', ""participants' eye gaze towards facial expressions"", 'eye gaze', 'negative emotion recognition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0871740', 'cui_str': 'Face Perception'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",73.0,0.296375,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.","[{'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Qingting', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China. Electronic address: chenxu@swu.edu.cn.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.173015']
1766,32835895,A twelve-month follow-up of an information communication technology delivered intervention for children with autism spectrum disorder living in regional Australia.,"This study investigated the long-term follow-up of an information communication techonology based intervention, the Therapeutic Outcomes By You application, for children with autism spectrum disorder living in regional Australia. Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes By You were assessed at least 12 months post-intervention to determine the maintenance or continued improvement of their language and social communication skills. Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.",2020,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","['Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes', 'children with autism spectrum disorder living in regional Australia']",[],"['receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]",15.0,0.0425543,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Parsons', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia. Electronic address: dave.parsons@curtin.edu.au.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Vaz', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Hoe', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Kids are Kids!, Australia.'}, {'ForeName': 'Reinie', 'Initials': 'R', 'LastName': 'Cordier', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia; Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, United Kingdom.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103743']
1767,31645648,A six-gene leukemic stem cell score identifies high risk pediatric acute myeloid leukemia.,"Recently, mRNA-expression signature enriched in LSCs was used to create a 17-gene leukemic stem cell (LSC17) score predictive of prognosis in adult AML. By fitting a Cox-LASSO regression model to the clinical outcome and gene-expression levels of LSC enriched genes in 163 pediatric participants of the AML02 multi-center clinical trial (NCT00136084), we developed a six-gene LSC score of prognostic value in pediatric AML (pLSC6). In the AML02 cohort, the 5-year event-free survival (EFS) of patients within low-pLSC6 group (n = 97) was 78.3 (95% CI = 70.5-86.9%) as compared with 34.5(95% CI = 24.7-48.2 %) in patients within high-pLSC6 group (n = 66 subjects), p < 0.00001. pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age. pLSC6 formula developed in the AML02 cohort was validated in the pediatric AML-TARGET project data (n = 205), confirming its prognostic value in both single-predictor and multiple-predictor Cox regression models. In both cohorts, pLSC6 predicted outcome of transplant patients, suggesting it as a useful criterion for transplant referrals. Our results suggest that pLSC6 score holds promise in redefining initial risk-stratification and identifying poor risk AML thereby providing guidance for developing novel treatment strategies.",2020,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","['risk pediatric acute myeloid leukemia', '163 pediatric participants']",['pLSC6'],"['EFS and overall survival (OS', '5-year event-free survival (EFS']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]",[],"[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",163.0,0.0725067,"pLSC6 remained significantly associated with EFS and overall survival (OS) after adjusting for induction 1-MRD status, risk-group, FLT3-status, WBC-count at diagnosis and age.","[{'ForeName': 'Abdelrahman H', 'Initials': 'AH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Rafiee', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Downing', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Ribeiro', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Gruber', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Sharyn', 'Initials': 'S', 'LastName': 'Baker', 'Affiliation': 'Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Klco', 'Affiliation': ""Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Rubnitz', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pounds', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jatinder K', 'Initials': 'JK', 'LastName': 'Lamba', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA. jlamba@cop.ufl.edu.'}]",Leukemia,['10.1038/s41375-019-0604-8']
1768,32857933,"Escitalopram in Adolescents With Generalized Anxiety Disorder: A Double-Blind, Randomized, Placebo-Controlled Study.","BACKGROUND


Selective serotonin reuptake inhibitors (SSRIs) are commonly used to treat pediatric anxiety disorders, including generalized anxiety disorder (GAD); however, their efficacy and tolerability are difficult to predict. This study evaluated the efficacy and tolerability of escitalopram in adolescents with GAD (DSM-IV-TR) and the impact of variants in HTR2A and serotonin transporter (SLC6A4) genes and cytochrome P450 2C19 (CYP2C19) phenotypes on response as well as CYP2C19 phenotype on escitalopram pharmacokinetics from February 2015 through November 2018.
METHODS


Patients were treated with escitalopram (forced titration to 15 mg/d, then flexible titration to 20 mg/d) (n = 26, mean ± SD age: 14.8 ± 1.7 years) or placebo (n = 25, mean ± SD age: 14.9 ± 1.6 years) for 8 weeks. Outcomes were the change in scores on the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Impressions (CGI) scales as well as vital signs and adverse events. Plasma escitalopram and desmethylcitalopram area under the curve during 24 hours (AUC0-24) and maximum concentration (Cmax) were determined and compared across CYP2C19 phenotypes.
RESULTS


Escitalopram was superior to placebo for mean ± SD baseline-to-endpoint change in PARS (-8.65 ± 1.3 vs -3.52 ± 1.1, P = .005) and CGI scores, and increasing CYP2C19 metabolism was associated with decreases in escitalopram Cmax (P = .07) and AUC0-24 (P < .05). Vital signs, corrected QT interval, and adverse events were similar in patients who received escitalopram and placebo.
CONCLUSIONS


Escitalopram reduces anxiety symptoms, and pharmacogenetics variables influence the trajectory and magnitude of improvement. Variation in CYP2C19 metabolism accounts for significant differences in escitalopram pharmacokinetics, raising the possibility that CYP2C19 phenotype should be considered when prescribing escitalopram.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02818751.",2020,Outcomes were the change in scores on the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Impressions (CGI) scales as well as vital signs and adverse events.,"['Adolescents', 'adolescents with GAD (DSM-IV-TR', 'With Generalized Anxiety Disorder', 'Patients were treated with']","['placebo', 'Placebo', 'serotonin reuptake inhibitors (SSRIs', 'escitalopram (forced titration']","['anxiety symptoms', 'Plasma escitalopram and desmethylcitalopram area under the curve during 24 hours (AUC0-24) and maximum concentration (Cmax', 'CYP2C19 metabolism', 'Vital signs, corrected QT interval, and adverse events', 'CGI scores', 'escitalopram Cmax', 'efficacy and tolerability', 'Pediatric Anxiety Rating Scale (PARS) and Clinical Global Impressions (CGI) scales as well as vital signs and adverse events']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162758', 'cui_str': 'Serotonin uptake inhibitor'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0057538', 'cui_str': 'desmethylcitalopram'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.181144,Outcomes were the change in scores on the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Impressions (CGI) scales as well as vital signs and adverse events.,"[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'University of Cincinnati, Department of Psychiatry, Box 670559, Cincinnati, OH 45267-0559. strawnjr@uc.edu.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Mills', 'Affiliation': 'Department of Economics, Lindner College of Business, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Schroeder', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Mossman', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Sara T', 'Initials': 'ST', 'LastName': 'Varney', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Ramsey', 'Affiliation': ""Department of Pediatrics, Divisions of Clinical Pharmacology & Research in Patient Services, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Poweleit', 'Affiliation': ""Department of Pediatrics, Divisions of Clinical Pharmacology & Research in Patient Services, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Zeruesenay', 'Initials': 'Z', 'LastName': 'Desta', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana,.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Cecil', 'Affiliation': ""Imaging Research Center, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'DelBello', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.20m13396']
1769,32859143,"Music attenuates a widened central pulse pressure caused by resistance exercise: A randomized, single-blinded, sham-controlled, crossover study.","Increasing central blood pressure is an independent predictor of cardiovascular disease and is an acute effect of high-intensity resistance exercise. It has been shown that classical music suppresses increased peripheral pressure during exercise. We hypothesized that classical music would suppress increased central pressure induced by high-intensity resistance exercise. To confirm this hypothesis, we examined the effect of classical music on central pressure following high-intensity resistance exercise in 18 young men. A randomized, single-blinded, sham-controlled, crossover trial was conducted under parallel experimental conditions on four separate days. The order of experiments was randomized between sham control (seated rest), music (20-min classical music track compilation), resistance exercise (5 sets of 10 repetitions at 75% of 1 repetition maximum), and resistance exercise with music conditions. Aortic pressure was measured in all subjects. No significant interaction between time, music, and resistance exercise was observed for aortic systolic pressure and diastolic pressure. In contrast, aortic pulse pressure showed a significant interaction; that is, aortic pulse pressure significantly widened after resistance exercise, whereas music significantly attenuated this widening. No significant change was observed in aortic pulse pressure in sham control and music conditions. The present findings suggest that music attenuates resistance exercise-induced increase in central pressure.",2020,No significant change was observed in aortic pulse pressure in sham control and music conditions.,['18 young men'],"['sham control (seated rest), music (20-min classical music track compilation), resistance exercise (5 sets of 10 repetitions at 75% of 1 repetition maximum), and resistance exercise with music conditions', 'Music attenuates a widened central pulse pressure caused by resistance exercise', 'classical music']","['Aortic pressure', 'time, music, and resistance exercise', 'aortic systolic pressure and diastolic pressure', 'central pressure', 'peripheral pressure', 'aortic pulse pressure']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C0456180', 'cui_str': 'Aortic pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C3494282', 'cui_str': 'Aortic Pulse Pressure'}]",18.0,0.249104,No significant change was observed in aortic pulse pressure in sham control and music conditions.,"[{'ForeName': 'Kaname', 'Initials': 'K', 'LastName': 'Tagawa', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakata', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Atsumu', 'Initials': 'A', 'LastName': 'Yokota', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Tomohito', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Maeda', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Japan.'}]",European journal of sport science,['10.1080/17461391.2020.1817153']
1770,32829060,The role of endogenous Antisecretory Factor (AF) in the treatment of Ménière's Disease: A two-year follow-up study. Preliminary results.,"PURPOSE


To evaluate the effects of increased endogenous Antisecretory Factor (AF) synthesis using specially processed cereals (SPC) in a sample of patients with defined unilateral Meniere's disease (MD), compared to the results of a treatment protocol of intravenous glycerol and dexamethasone.
MATERIALS AND METHODS


Twenty-six patients with unilateral MD were divided in 2 groups and treated with SPC and with intravenous glycerol and dexamethasone for 24 months. Audio-vestibular evaluation was performed before (T0) and every six months. The number of vertigo spells were evaluated before and after therapy and the Efficacy Index (EI) was calculated. Questionnaires for hearing loss, tinnitus and quality of life were administered.
RESULTS


EI decreased in the SPC group after 18 (T18) (p = .0017) and 24 (T24) months of therapy (p = .0111). There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131). No significant differences were found between the two groups at T0 (p = .4723), while a significant difference was found at T24 (p = .0027). Quality of life showed a significant improvement in daily activities in the SPC group (p = .0033) compared to the infusion therapy group. No statistically significant changes in PTA thresholds were found in both groups between T0 and T24.
CONCLUSION


The preliminary results of our study show a significant reduction of vertigo spells and a positive effect on tinnitus severity and on quality of life in patients with unilateral MD treated with SPC and when compared to patients treated with intravenous glycerol and dexamethasone. No effects on hearing thresholds were noted in both groups.",2020,There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131).,"['Twenty-six patients with unilateral MD', ""Ménière's Disease"", 'patients with unilateral MD treated with', ""patients with defined unilateral Meniere's disease (MD""]","['SPC and with intravenous glycerol and dexamethasone', 'endogenous Antisecretory Factor (AF', 'glycerol and dexamethasone', 'intravenous glycerol and dexamethasone', 'SPC', 'endogenous Antisecretory Factor (AF) synthesis using specially processed cereals (SPC']","['Efficacy Index (EI', 'number of vertigo spells', 'daily activities', 'tinnitus severity and on quality of life', 'hearing thresholds', 'hearing loss, tinnitus and quality of life', 'Quality of life', 'vertigo spells', 'PTA thresholds', 'tinnitus score']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0025281', 'cui_str': ""Ménière's disease""}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0052093', 'cui_str': 'antisecretory factor'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",26.0,0.0201493,There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131).,"[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Viola', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Pisani', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Scarpa', 'Affiliation': 'Department of Medicine and Surgery, University of Salerno, Salerno, Italy. Electronic address: alfonsoscarpa@yahoo.it.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cassandro', 'Affiliation': 'Surgical Sciences Department, University of Turin, Turin, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Laria', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit of Audiology, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Teodoro', 'Initials': 'T', 'LastName': 'Aragona', 'Affiliation': 'Otolaryngology, A.O.U. Ospedali Riuniti, Ancona, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ciriolo', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Spadera', 'Affiliation': 'Otolaryngology, San Leonardo Hospital, Castellammare di Stabia, Napoli, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': 'Department of Sense Organs, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavaliere', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit Ear, Nose and Throat Section, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Iengo', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit Ear, Nose and Throat Section, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Chiarella', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102673']
1771,32829654,Casein Hydrolysate Containing Milk-Derived Peptides Reduces Facial Pigmentation Partly by Decreasing Advanced Glycation End Products in the Skin: A Randomized Double-Blind Placebo-Controlled Trial.,"Casein hydrolysate has been shown to improve arterial stiffness as estimated by brachial-ankle pulse wave velocity (baPWV) in untreated hypertensive patients. Facial pigmentation is associated with atherosclerosis, both of which are supposed to be modulated by tissue accumulation of advanced glycation end products (AGEs). However, effects of casein hydrolysate on facial pigmentation and AGEs remain largely unknown. This randomized double-blind placebo-controlled trial evaluated whether and how casein hydrolysate improves facial pigmentation in 80 nonhypertensive Japanese patients. Study participants were randomly assigned to receive either active tablets containing casein hydrolysate or placebo for 48 weeks. Facial pigmentation area, baPWV, and skin accumulation levels of AGEs were evaluated by Robo Skin Analyzer RSA50S II, volume-plethysmographic apparatus, and AGE Reader, respectively, at baseline and at the end of the intervention. Treatment with casein hydrolysate, but not placebo significantly reduced triglycerides and facial pigmentation area. There were significant differences of changes in triglycerides, facial pigmentation area, skin accumulation levels of AGEs, and baPWV between the two groups. Furthermore, changes in triglycerides and skin accumulation levels of AGEs were positively and independently associated with those in facial pigmentation area, whereas changes in baPWV were not. This study suggests that casein hydrolysate reduces facial pigmentation area in nonhypertensive participants partly by decreasing skin accumulation levels of AGEs. Clinical-Trials.gov ID: UMIN000027675.",2020,"There were significant differences of changes in triglycerides, facial pigmentation area, skin accumulation levels of advanced glycation end products, and brachial-ankle pulse wave velocity between the two groups.","['untreated hypertensive patients', '80 non-hypertensive Japanese patients']","['casein hydrolysate', 'Casein hydrolysate containing milk-derived peptides', 'Casein hydrolysate', 'placebo', 'active tablets containing casein hydrolysate or placebo']","['Facial pigmentation area, brachial-ankle pulse wave velocity, and skin accumulation levels of advanced glycation end products', 'triglycerides and facial pigmentation area', 'triglycerides, facial pigmentation area, skin accumulation levels of advanced glycation end products, and brachial-ankle pulse wave velocity', 'facial pigmentation', 'brachial-ankle pulse wave velocity', 'facial pigmentation area', 'arterial stiffness', 'facial pigmentation and advanced glycation', 'Robo Skin Analyzer RSA50S II, volume-plethysmographic apparatus, and AGE Reader', 'triglycerides and skin accumulation levels of advanced glycation end products']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0054845', 'cui_str': 'Casein hydrolysate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",80.0,0.315026,"There were significant differences of changes in triglycerides, facial pigmentation area, skin accumulation levels of advanced glycation end products, and brachial-ankle pulse wave velocity between the two groups.","[{'ForeName': 'Michiya', 'Initials': 'M', 'LastName': 'Igase', 'Affiliation': 'Department of Antiaging Medicine, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Department of Antiaging Medicine, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Igase', 'Affiliation': 'Department of Advanced Brain Therapy, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Geriatric Medicine and Neurology, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Senzaki', 'Affiliation': 'Department of Geriatric Medicine and Neurology, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ochi', 'Affiliation': 'Department of Geriatric Medicine and Neurology, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Ohyagi', 'Affiliation': 'Department of Geriatric Medicine and Neurology, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Sho-Ichi', 'Initials': 'SI', 'LastName': 'Yamagishi', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}]",Rejuvenation research,['10.1089/rej.2020.2343']
1772,32830463,Kinetic-Pharmacodynamic Model of Platelet Time Course in Patients With Moderate-to-Severe Atopic Dermatitis Treated With Oral Janus Kinase 1 Inhibitor Abrocitinib.,"The oral Janus kinase 1 (JAK1) inhibitor abrocitinib reduced signs and symptoms of atopic dermatitis (AD) in a placebo-controlled, randomized, double-blind, phase IIb trial (dose range 10-200 mg). A kinetic-pharmacodynamic (K-PD) model consisting of proliferation, maturation, and blood circulation compartments was developed to characterize platelet count changes during the study. The K-PD model consisted of a drug elimination constant, four system parameters describing platelet dynamics, variance terms, correlation, and residual errors. Overall, these patients exhibited mean transit time from progenitor cells to platelets of 8.2 days (longer than the reported megakaryocyte life span), likely arising from JAK1-induced perturbations of platelet progenitor homeostasis. The final model described dose-related platelet count declines until nadir at treatment week 4 and return to baseline levels thereafter. The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.",2020,The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.,['Patients With Moderate-to-Severe Atopic Dermatitis'],[],['mean transit time'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.114435,The model was deemed suitable to support the design of subsequent abrocitinib AD trials and indicated limited clinically relevant platelet reductions in the range of doses studied.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Soto', 'Affiliation': 'Pfizer UK Limited, Sandwich, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Peterson', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}]",CPT: pharmacometrics & systems pharmacology,['10.1002/psp4.12548']
1773,32830635,Prolonged intra-operative thermal exposure in endoscopic ear surgery: is it really safe?,"OBJECTIVE


The aim of this study was to assess change in temperature, audiometric outcomes and post-operative complications following exposure to different light sources during endoscopic ear surgery.
METHOD


A total of 64 patients diagnosed with chronic otitis media with central perforation and pure conductive hearing loss underwent endoscopic type 1 tympanoplasty. The patients were randomised into two groups based on the light source used: xenon or light-emitting diode. Temperature was measured using a K type thermocouple at the promontory and round window niche. Mean temperature change with respect to operating time, mean audiometric change, incidence of vomiting in the first 24 hours, vertigo and tinnitus at the end of the first week were observed.
RESULTS


Mean temperature change showed a statistically significant difference with increasing length of operating time with the xenon light source and when the two light sources were compared for a particular time interval. Mean audiometric change showed statistically significant deterioration at higher frequencies (4, 6 and 8 kHz) with the xenon light source but only at 8 kHz for the light emitting diode source. When the mean audiometric change was compared between light sources for a particular frequency, statistical significance was found at 4, 6 and 8 kHz. Post-operative complications were vomiting, vertigo and tinnitus (p-values of 0.042, 0.099 and 0.147, respectively, between two groups).
CONCLUSION


Light emitting diodes are associated with less significant middle-ear temperature rises and audiometric changes at higher frequencies when compared to xenon light sources. Hence, xenon should be replaced with cooler light sources.",2020,"Mean audiometric change showed statistically significant deterioration at higher frequencies (4, 6 and 8 kHz) with the xenon light source but only at 8 kHz for the light emitting diode source.","['64 patients diagnosed with chronic otitis media with central perforation and pure conductive hearing loss underwent endoscopic type 1 tympanoplasty', 'endoscopic ear surgery']",['light source used: xenon or light-emitting diode'],"['vertigo and tinnitus', 'Mean audiometric change', 'change in temperature, audiometric outcomes', 'length of operating time', 'mean audiometric change', 'vomiting, vertigo and tinnitus', 'Mean temperature change with respect to operating time, mean audiometric change, incidence of vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0271441', 'cui_str': 'Chronic otitis media'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038899', 'cui_str': 'Otologic Surgical Procedure'}]","[{'cui': 'C0181633', 'cui_str': 'Light source'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0023693', 'cui_str': 'Light'}]","[{'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0450031', 'cui_str': 'Temperature change'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",64.0,0.0279896,"Mean audiometric change showed statistically significant deterioration at higher frequencies (4, 6 and 8 kHz) with the xenon light source but only at 8 kHz for the light emitting diode source.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}]",The Journal of laryngology and otology,['10.1017/S0022215120001449']
1774,32839797,Effects of pomegranate peel extract and vitamin E on the inflammatory status and endothelial function in hemodialysis patients: a randomized controlled clinical trial.,"Inflammation and endothelial dysfunction are major problems in hemodialysis (HD) patients. This study assessed the effects of an 8 week administration of pomegranate peel extract (PPE) and vitamin E (Vit E) alone or in combination on the biomarkers of inflammation, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), and the biomarkers of endothelial function, including intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), and P-selectin, in HD patients. In a randomized, double-blind, parallel, placebo-controlled trial, 100 HD patients were randomly divided into 4 equal groups: (a) PPE + Vit E, received 2 pomegranate tablets (each tablet contained 225 mg PPE, equal to 90 mg ellagic acid) + 1 Vit E soft gel (400 IU) daily, (b) PPE, received 2 pomegranate tablets + 1 Vit E placebo soft gel daily, (c) Vit E, received 1 Vit E soft gel + 2 pomegranate placebo tablets daily, and (d) placebo, received 2 pomegranate placebo tablets + 1 Vit E placebo soft gel daily. For group allocation, a stratified block randomization procedure based on sex, age, and HD duration was used. Each intervention product and its placebo had identical shape, color, size, and packaging. Consumption of PPE + Vit E significantly reduced the serum CRP level (mean change: -7.12 ± 4.59 mg l-1, P < 0.001) compared to other groups, while reduced levels of IL-6 (mean change: -2.19 ± 2.33 pg ml-1, P < 0.001), TNF-α (mean change: -2.41 ± 3.21 pg ml-1, P = 0.008), ICAM-1 (mean change: -64.2 ± 111.0 ng ml-1, P = 0.017), and VCAM-1 (mean change: -117.7 ± 177.1 ng ml-1, P = 0.002) were observed compared to the control. There was no significant difference in the P-selectin level among the groups. Consumption of PPE or Vit E alone significantly reduced the CRP level (mean change for PPE: -3.58 ± 5.41 mg l-1, P < 0.001; mean change for Vit E: -3.25 ± 8.29 mg l-1, P = 0.002) compared to the control. As a result, consumption of PPE in combination with Vit E enhanced the inflammatory status and endothelial function in HD patients.",2020,"Consumption of PPE + Vit E significantly reduced the serum CRP level (mean change: -7.12 ± 4.59 mg l-1, P < 0.001) compared to other groups, while reduced levels of IL-6 (mean change: -2.19 ± 2.33 pg ml-1, P < 0.001), TNF-α (mean change: -2.41 ± 3.21 pg ml-1, P = 0.008), ICAM-1 (mean change: -64.2 ± 111.0 ng ml-1, P = 0.017), and VCAM-1 (mean change: -117.7 ± 177.1 ng ml-1, P = 0.002) were observed compared to the control.","['100 HD patients', 'HD patients', 'hemodialysis patients', 'hemodialysis (HD) patients']","['PPE or Vit E', 'PPE + Vit E, received 2 pomegranate tablets (each tablet contained 225 mg PPE, equal to 90 mg ellagic acid) + 1 Vit E soft gel (400 IU) daily, (b) PPE, received 2 pomegranate tablets + 1 Vit E placebo soft gel daily, (c) Vit E, received 1 Vit E soft gel + 2 pomegranate placebo tablets daily, and (d) placebo, received 2 pomegranate placebo tablets + 1 Vit E placebo soft gel daily', 'pomegranate peel extract (PPE) and vitamin E (Vit E', 'Vit E', 'PPE + Vit E', 'pomegranate peel extract and vitamin E', 'placebo']","['Inflammation and endothelial dysfunction', 'VCAM-1', 'ICAM-1', 'TNF-α', 'CRP level', 'P-selectin level', 'biomarkers of inflammation, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), and the biomarkers of endothelial function, including intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), and P-selectin', 'levels of IL-6', 'serum CRP level', 'inflammatory status and endothelial function']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1509685', 'cui_str': 'POMEGRANATE FRUIT EXTRACT'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0013900', 'cui_str': 'Ellagic Acid'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1277266', 'cui_str': 'Serum C reactive protein level'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",100.0,0.256857,"Consumption of PPE + Vit E significantly reduced the serum CRP level (mean change: -7.12 ± 4.59 mg l-1, P < 0.001) compared to other groups, while reduced levels of IL-6 (mean change: -2.19 ± 2.33 pg ml-1, P < 0.001), TNF-α (mean change: -2.41 ± 3.21 pg ml-1, P = 0.008), ICAM-1 (mean change: -64.2 ± 111.0 ng ml-1, P = 0.017), and VCAM-1 (mean change: -117.7 ± 177.1 ng ml-1, P = 0.002) were observed compared to the control.","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Jafari', 'Affiliation': 'Department of Biochemistry and Nutrition, Faculty of Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran. tinajafari15@yahoo.com.'}, {'ForeName': 'Aziz A', 'Initials': 'AA', 'LastName': 'Fallah', 'Affiliation': 'Department of Food Hygiene and Quality Control, Faculty of Veterinary Medicine, Shahrekord University, Shahrekord 34141, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Reyhanian', 'Affiliation': 'Department of Biochemistry and Nutrition, Faculty of Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran. tinajafari15@yahoo.com.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Sarmast', 'Affiliation': 'Department of Food Hygiene and Quality Control, Faculty of Veterinary Medicine, Shahrekord University, Shahrekord 34141, Iran.'}]",Food & function,['10.1039/d0fo01012j']
1775,32836188,Comparison of low and high inspiratory oxygen fraction added to lung-protective ventilation on postoperative pulmonary complications after abdominal surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Intraoperative lung-protective ventilation strategy has been recommended to reduce postoperative pulmonary complications (PPCs). However, the role of inspiratory oxygen fraction (FiO 2 ) in this protection remains highly uncertain. We aimed to evaluate the effect of intraoperative low (30%) versus high (80%) FiO 2  in the context of lung-protective ventilation strategy on PPCs in patients undergoing abdominal surgery.
DESIGN


Prospective, two-arm, randomized controlled trial.
SETTING


Tertiary university hospital in China.
PATIENTS


A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study.
INTERVENTION


Patients were randomly assigned to receive either 30% or 80% FiO 2  during the intraoperative period. All patients received volume-controlled mechanical ventilation with lung-protective ventilation approach, which included a tidal volume of 8 ml kg -1  of predicted body weight, a positive end-expiratory pressure level of 6-8 cmH 2 O, and repeated recruitment maneuvers.
MEASUREMENTS


The primary outcome was a composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis. The severity grade of PPCs was measured as a key secondary outcome.
MAIN RESULTS


Two hundred and fifty-one patients completed the trial. PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025). The severity of PPCs within the first 7 days following surgery was attenuated significantly in the low (30%) FiO 2  group (p = 0.001).
CONCLUSIONS


Among patients undergoing abdominal surgery under general anesthesia, an intraoperative lung-protective ventilation strategy with 30% FiO 2  compared with 80% FiO 2  did not reduce the incidence of PPCs. And the use of 30% FiO 2  resulted in less severe pulmonary complications.",2020,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","['patients undergoing abdominal surgery', 'patients undergoing abdominal surgery under general anesthesia', 'Tertiary university hospital in China', 'Two hundred and fifty-one patients completed the trial', 'A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study', 'postoperative pulmonary complications after abdominal surgery']","['volume-controlled mechanical ventilation with lung-protective ventilation approach', 'low and high inspiratory oxygen fraction added to lung-protective ventilation']","['severe pulmonary complications', 'composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis', 'PPCs', 'severity of PPCs', 'severity grade of PPCs', 'incidence of PPCs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0449972', 'cui_str': 'Volume control'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",252.0,0.482006,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","[{'ForeName': 'Xue-Fei', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Yu-Lian', 'Initials': 'YL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Meng-Qiu', 'Initials': 'MQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Jia-Li', 'Initials': 'JL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Lei-Lei', 'Initials': 'LL', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China. Electronic address: yuhaishan117@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110009']
1776,32841683,"Oral administration of porcine liver decomposition product for 4 weeks enhances visual memory and delayed recall in healthy adults over 40 years of age: A randomized, double-blind, placebo-controlled study.","BACKGROUND AND OBJECTIVES


Porcine liver decomposition product (PLDP) contains neurofunctional phospholipids. We previously reported that PLDP enhances cognitive function in healthy adult humans, based on clinical evaluations using Hasegawa's Dementia Scale-Revised. In this study, we evaluated the effect of PLDP on memory indicators of the Wechsler Memory Scale-Revised (WMS-R), an internationally recognized battery for memory assessment.
METHODS


We conducted a double-blind parallel-group placebo-controlled trial to evaluate the effect of PLDP on memory. Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the placebo group. Each group was administered PLDP (4 capsules) or a placebo (4 capsules) for 4 continuous weeks. WMS-R was administered before and 4 weeks after PLDP or placebo intake. The data were also subdivided by age for participants under 40 years (N = 15 in PLDP; N = 15 in placebo) and over 40 years (N = 13 in PLDP, N = 15 in placebo). Changes in Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall were analyzed.
RESULTS


No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age. However, for participants over 40 years of age, PLDP administration resulted in a significant enhancement than placebo administration in Delayed Recall (14.1 ± 7.1 points vs. 7.1 ± 6.8 points) (P < 0.05), Visual Recall I (20.1 ± 23.1 percentile vs 1.9 ± 22.8 percentile) (P < 0.05), and Visual Recall II (24.2 ± 25.8 percentile vs 6.7 ± 19.0 percentile) (P < 0.05), respectively. The composition ratio of men to women in each group was imbalanced but no significant difference existed between the two groups.
LIMITATIONS


A modest sample size, single-center design, and a fairly short follow-up period.
CONCLUSION


PLDP enhanced Visual Memory and Delayed Recall in healthy adults over 40 years of age but not in healthy adults under 40 years of age. Therefore, PLDP may represent a promising nutraceutical that could improve cognitive function in healthy adults over 40 years of age. Further studies are required to evaluate if long term PLDP administration can prevent or delay cognitive dysfunction in healthy adults over 40 years of age.",2020,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"['Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the', 'healthy adults over 40\u202fyears of age', 'healthy adult humans', 'participants under 40\u202fyears (N\u202f=\u202f15 in PLDP; N\u202f=\u202f15 in placebo) and over 40\u202fyears (N\u202f=\u202f13 in PLDP, N\u202f=\u202f15 in', 'healthy adults over 40\u202fyears of age but not in healthy adults under 40\u202fyears of age']","['PLDP', 'placebo', 'porcine liver decomposition product']","['Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall', 'Visual Recall I', 'Visual Memory and Delayed Recall', 'cognitive function', 'memory indicators of the Wechsler Memory Scale-Revised (WMS-R', 'visual memory and delayed recall', 'composition ratio', 'Visual Recall', 'memory indicators', 'Delayed Recall']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",28.0,0.574256,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan. Electronic address: yomatsuda@nichiyaku.ac.jp.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Haniu', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Pharmacology and Therapeutic Innovation, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8521, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Uemura', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan; Division of Gene Research, Research Center for Supports to Advanced Science, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Sako', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kojima', 'Affiliation': 'Medical and Health Resources Research Institute, Tokyo 170-0013, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Mori Neurosurgery Clinic, Tokyo 142-0053, Japan.'}, {'ForeName': 'Kazusaburou', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Sugar Lady Cosmetics Co., Ltd, Tokyo 107-6011, Japan.'}]",Experimental gerontology,['10.1016/j.exger.2020.111064']
1777,32842270,[Efficacy and safety of alirocumab versus ezetimibe in high cardiovascular risk Chinese patients with hyperlipidemia: ODYSSEY EAST Study-Chinese sub-population analysis].,"Objective:  To compare the efficacy and safety profile of alirocumab (PCSK9 inhibitor) versus ezetimibe on top of maximally tolerated statin dose in high cardiovascular risk Chinese patients with hyperlipidemia.  Methods:  The ODYSSEY EAST study was a randomized, double-blinded, double dummy, active-control, parallel group, multi-centers clinical trial, the Chinese sub-population included 456 patients with hyperlipidemia and high cardiovascular risk on maximally tolerated statin dose. Patients were randomized (2∶1) to receive the subcutaneous injection of alirocumab (75 mg Q2W; with dose up titration to 150 mg Q2W at week 12 if low-density lipoprotein cholesterol (LDL-C) was ≥1.81 mmol/L at week 8) or the oral administration of ezetimibe (10 mg daily) for 24 weeks. The primary endpoint was percentage change in calculated LDL-C from baseline to week 24. Key secondary efficacy endpoints included percentage change from baseline to week 12 or 24 in LDL-C (week 12) and other lipid parameters, including apolipoprotein (Apo) B, non-high-density lipoprotein cholesterol (non-HDL-C), TC, lipoprotein(a) (Lp(a)), HDL-C, fasting triglycerides (TG), and Apo A1, and the proportion of patients reaching LDL-C<1.81 mmol/L at week 24. Safety profile of therapeutic drugs was also assessed during the treatment period.  Results:  The mean age of 456 Chinese patients was (59.5±10.9) years, 341(74.8%) patients were male, 303 patients (66.4%) in alirocumab group and 153 patients (33.5%) in ezetimibe group. Demographic characteristics, disease characteristics, and lipid parameters at baseline were similar between the two groups. LDL-C was reduced more from baseline to week 12 and 24 in alirocumab group versus ezetimibe group, the difference of their least-squares mean (standard error) percent change were(-35.2±2.2)% and (-36.9±2.5)% (both  P <0.001). At 12 weeks, alirocumab had significant reduction on Lp(a), Apo B, total cholesterol and non HDL-C, the difference of their least-squares mean (standard error) percent change were (-40.3±2.8)%, (-27.7±1.8)%, (-19.6±1.5)% and (-27.7±1.9)%, respectively (all  P <0.001). At 24 weeks, the percent of patients who reached LDL-C<1.81 mmol/L and LDL-C<1.42 mmol/L was significantly higher in alirocumab group (85.3% and 70.5%) than in ezetimibe group (42.2% and 17.0%, both  P <0.001), and alirocumab use was also associated with significant reduction on Lp(a), Apo B, total cholesterol and non HDL-C, the difference of their least-squares mean (standard error) percent change were (-37.2±2.8)%, (-29.1±2.0)%, (-21.6±1.6)% and (-29.6±2.2)%, respectively (all  P <0.001). The incidence of treatment related adverse events was similar between the two treatment groups (223/302 patients (73.8%) in alirocumab group and 109/153 patients (71.2%) in ezetimibe group). Respiratory infection, urinary infection, dizziness and local injection-site reactions were the most frequently reported adverse events.  Conclusions:  In high cardiovascular risk patients with hyperlipidemia from China on maximally tolerated statin dose, the reduction of LDL-C induced by alirocumab is more significant than that induced by ezetimibe. Both treatments were generally safe during the observation period of study.",2020,"LDL-C was reduced more from baseline to week 12 and 24 in alirocumab group versus ezetimibe group, the difference of their least-squares mean (standard error) percent change were(-35.2±2.2)% and (-36.9±2.5)% (both  P <0.001).","['high cardiovascular risk Chinese patients with hyperlipidemia', 'patients were male, 303 patients (66.4%) in alirocumab group and 153 patients (33.5%) in ezetimibe group', '456 patients with hyperlipidemia and high cardiovascular risk on maximally tolerated statin dose', 'The mean age of 456 Chinese patients was (59.5±10.9) years, 341(74.8']","['ezetimibe', 'subcutaneous injection of alirocumab', 'alirocumab versus ezetimibe', 'alirocumab', 'alirocumab (PCSK9 inhibitor']","['LDL-C (week 12) and other lipid parameters, including apolipoprotein (Apo) B, non-high-density lipoprotein cholesterol (non-HDL-C), TC, lipoprotein(a) (Lp(a)), HDL-C, fasting triglycerides (TG), and Apo A1, and the proportion of patients reaching LDL', 'adverse events', 'Respiratory infection, urinary infection, dizziness and local injection-site reactions', 'percentage change in calculated LDL-C', 'LDL-C', 'Lp(a), Apo B, total cholesterol and non HDL-C', 'Demographic characteristics, disease characteristics, and lipid parameters']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4521460', 'cui_str': 'PCSK9 inhibitor'}]","[{'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",456.0,0.167077,"LDL-C was reduced more from baseline to week 12 and 24 in alirocumab group versus ezetimibe group, the difference of their least-squares mean (standard error) percent change were(-35.2±2.2)% and (-36.9±2.5)% (both  P <0.001).","[{'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General Hospital of Northern War Zone, Shenyang 110016, China.'}, {'ForeName': 'Y Y', 'Initials': 'YY', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, General Hospital of Northern War Zone, Shenyang 110016, China.'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Su', 'Affiliation': 'Department of Cardiology, Jinan Central Hospital Affiliated to Shandong University, Jinan 250000, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern War Zone, Shenyang 110016, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Medical, Sanofi (China) Investment Co., Ltd. Shanghai Branch, Shanghai 200040, China.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Liu', 'Affiliation': 'R&D, Sanofi (China) Investment Co., Ltd. Shanghai Branch, Shanghai 200040, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'R&D, Sanofi (China) Investment Co., Ltd. Shanghai Branch, Shanghai 200040, China.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Li', 'Affiliation': 'R&D, Sanofi (China) Investment Co., Ltd. Shanghai Branch, Shanghai 200040, China.'}]",Zhonghua xin xue guan bing za zhi,['10.3760/cma.j.cn112148-20191216-00755']
1778,32842315,[Safety and immunogenicity analysis of recombinant （hansenula polymorpha) hepatitis B vaccine （CpG ODN adjuvant) among adults: the preliminary results of phase I clinical trial].,"Objective:  To evaluate the safety and immune effect of recombinant hepatitis B vaccine （CpG ODN adjuvant).  Methods:  On Oct. 26, 2016, we launched volunteer recruitment in Kaihua county, Quzhou city, Zhejiang Province. In the randomized, double-blind, controlled trial, a total of 48 subjects with negative HBV screening tests and normal hepatorenal function among 18 and 60 years old were selected and divided into two groups randomly, 24 cases each. The experimental group was given 250 μg of CpG ODN recombinant （Hansenula polymorpha) Hepatitis B vaccine and the control group was given 10 μg of commercial Hepatitis B vaccine with timed at 0, 1and 6 months. The inoculation reactions were compared the difference between the two groups after observed and recorded in time periods. We also collected serum before and after immunization to compare the two groups of anti-HBs positive rate, geometric mean concentration（GMC).  Results:  During the study period, the incidence of adverse events was 66.67%（16/24) in the experimental group and 54.17%（13/24) in the control group, with no significant difference（ P =0.556). The severities of adverse events were level 1 or level 2, and no level 3 or above adverse reactions occurred. After full-course immunization, in the FAS data set, the anti-HBs GMC in the experimental group [2 598.56（1 127.90-5 986.90) mIU/ml] was higher than that in the control group[371.97（164.54-840.91) mIU/ml] In the PPS set, the GMC of test group was 7 808.21（3 377.00-18 052.00) mIU/ml, which was higher than that of the control group [843.22（213.80-3 325.90) mIU/ml]. The anti-HBs positive rate of FAS（PPS) was 95.83%（100.00%) in the experimental group and the control group; The anti-HBs strongly positive rate of FAS（PPS) was 79.17%（90.00%) in the experimental group and 33.33%（50.00%) in the control group, with statistically significant differences among the FAS set（ P =0.003) and no statistically significance differences among the PPS set（ P =0.074).  Conclusion:  CpG Hepatitis B Vaccine is safe and shows better immunogenicity than the control vaccine.",2020,"During the study period, the incidence of adverse events was 66.67%（16/24) in the experimental group and 54.17%（13/24) in the control group, with no significant difference（ P =0.556).","['48 subjects with negative HBV screening tests and normal hepatorenal function among 18 and 60 years old', 'adults', 'On Oct. 26, 2016, we launched volunteer recruitment in Kaihua county, Quzhou city, Zhejiang Province']","['recombinant hepatitis B vaccine （CpG ODN adjuvant', 'mIU/ml', 'recombinant （hansenula polymorpha) hepatitis B vaccine （CpG ODN adjuvant']","['anti-HBs positive rate of FAS（PPS', 'severities of adverse events', 'inoculation reactions', 'incidence of adverse events', 'anti-HBs strongly positive rate of FAS（PPS']","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0914671', 'cui_str': 'CPG-ODN'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C0319605', 'cui_str': 'Pichia angusta'}]","[{'cui': 'C0149708', 'cui_str': 'Hepatitis B surface antibody positive'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0201478', 'cui_str': 'Hepatitis B surface antibody measurement'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",48.0,0.0592319,"During the study period, the incidence of adverse events was 66.67%（16/24) in the experimental group and 54.17%（13/24) in the control group, with no significant difference（ P =0.556).","[{'ForeName': 'Z Z', 'Initials': 'ZZ', 'LastName': 'Liang', 'Affiliation': 'Institute for Immunization and Prevention, Zhejiang Provincial Center of Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Changchun Huapu Bio-Tech Co., Ltd, Changchun 130103, China.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Wang', 'Affiliation': 'Institute for Immunization and Prevention, Zhejiang Provincial Center of Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Yan', 'Affiliation': 'Kaihua Center of Disease Control and Prevention, Quzhou 324300, Zhejiang Province, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Kaihua Center of Disease Control and Prevention, Quzhou 324300, Zhejiang Province, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Changchun Huapu Bio-Tech Co., Ltd, Changchun 130103, China.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Chen', 'Affiliation': 'Institute for Immunization and Prevention, Zhejiang Provincial Center of Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'X S', 'Initials': 'XS', 'LastName': 'Hu', 'Affiliation': 'Institute for Immunization and Prevention, Zhejiang Provincial Center of Disease Control and Prevention, Hangzhou 310051, China.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Lyu', 'Affiliation': 'Institute for Immunization and Prevention, Zhejiang Provincial Center of Disease Control and Prevention, Hangzhou 310051, China.'}]",Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine],['10.3760/cma.j.cn112150-20200401-00490']
1779,32842336,[Comparative analysis of the clinical application of two femtosecond laser-assisted cataract operation platforms].,"Objective:  To evaluate the operability and clinical application effects of femtosecond laser-assisted cataract surgery systems of LenSx and LenSAR.  Methods:  This was a randomized controlled study. A total of 86 patients (90 eyes) who underwent femtosecond laser-assisted cataract surgery in Wuhan Aier Eye Hospital from April 2018 to November 2018 were enrolled and divided into two groups randomly, including 44 patients (45 eyes) in the LenSx group and 42 patients (45 eyes) in the LenSAR group. During the operation, the following observation indexes were obtained. Operational indicators included the number of docking attempts, anterior capsulotomy time, nucleus pre-treatment time, total femtosecond laser emission time, and total vacuum suction duration. Clinical outcome indicators included changes in the patient's intraocular pressure during femtosecond laser surgery, the rate of subconjunctival hemorrhage, capsulotomy integrity (yes/no), roundness and centricity of the anterior capsule opening (yes/no), the rate of anterior capsule opening tear, and the rate of posterior capsule rupture. The  t -test, rank-sum test or chi-square test were used for statistical analysis.  Results:  There were no significant differences between groups in the age and the lens density (both  P >0.05). The number of docking attempts in the LenSx group was 1 (1 to 4) and in the LenSAR group was 1 (1 to 2); there was statistically significant difference ( Z  =-2.23,  P <0.05). The difference in the anterior capsulotomy time between the two groups was statistically significant [13.00 (10.00 to 22.00) s compared with 3.00 (1.00 to 3.00) s,  Z =-8.71,  P <0.05]. The femtosecond laser pre-nucleation time and total femtosecond laser emission time of the LenSx group were (16.67±3.36) s and (30.49±3.53) s, and those of the LenSAR group were (12.38±4.36) s and (15.36±4.29) s, respectively; the differences between the two groups were statistically significant ( t =-5.23, -18.26; both  P <0.05). The total vacuum suction duration in the LenSx group was (97.23±19.96) s, shorter than that in the LenSAR group [(123.76±16.81) s] ( t =6.82,  P <0.05). The intraocular pressure after femtosecond laser surgery in both groups was higher than that before surgery. The increase of intraocular pressure in the LenSAR group was (5.64±5.42) mmHg (1 mmHg=0.133 kPa), higher than that in the LenSx group [(2.99±4.66) mmHg] ( t =-2.49,  P <0.05). The rate of subconjunctival hemorrhage in the LenSx group was 33.3% (15/45), while it was 8.9% (4/45) in the LenSAR group; the difference between the two groups was statistically significant (χ²=6.67,  P <0.05). There were no significant differences between groups in capsulotomy integrity, roundness and centricity of the anterior capsule opening, the rate of anterior capsule opening tear, and the rate of posterior capsule rupture (all  P >0.05).  Conclusion:  The docking process of the LenSAR system is convenient, and there is less subconjunctival hemorrhage; the total vacuum suction duration of LenSx is short, and the increase of intraocular pressure is low.  (Chin J Ophthalmol, 2020, 56: 530-535) .",2020,"There were no significant differences between groups in capsulotomy integrity, roundness and centricity of the anterior capsule opening, the rate of anterior capsule opening tear, and the rate of posterior capsule rupture (all  P >0.05).  ","['in Wuhan Aier Eye Hospital from April 2018 to November 2018 were enrolled and divided into two groups randomly, including 44 patients (45 eyes) in the LenSx group and 42 patients (45 eyes) in the LenSAR group', '86 patients (90 eyes) who underwent']","['femtosecond laser surgery', 'femtosecond laser-assisted cataract operation platforms', 'femtosecond laser-assisted cataract surgery', 'femtosecond laser-assisted cataract surgery systems']","['number of docking attempts', 'femtosecond laser pre-nucleation time and total femtosecond laser emission time', 'capsulotomy integrity, roundness and centricity of the anterior capsule opening, the rate of anterior capsule opening tear, and the rate of posterior capsule rupture', 'total vacuum suction duration', ""patient's intraocular pressure during femtosecond laser surgery, the rate of subconjunctival hemorrhage, capsulotomy integrity (yes/no), roundness and centricity of the anterior capsule opening (yes/no), the rate of anterior capsule opening tear, and the rate of posterior capsule rupture"", 'anterior capsulotomy time', 'lens density', 'rate of subconjunctival hemorrhage', 'intraocular pressure', 'number of docking attempts, anterior capsulotomy time, nucleus pre-treatment time, total femtosecond laser emission time, and total vacuum suction duration']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1504458', 'cui_str': 'Cataract operation'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442632', 'cui_str': 'Dock - marine'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1535895', 'cui_str': 'Posterior capsule rupture'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",86.0,0.0284372,"There were no significant differences between groups in capsulotomy integrity, roundness and centricity of the anterior capsule opening, the rate of anterior capsule opening tear, and the rate of posterior capsule rupture (all  P >0.05).  ","[{'ForeName': 'Y X', 'Initials': 'YX', 'LastName': 'Xu', 'Affiliation': 'Aier School of Ophthalmology, Central South University, Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Bao', 'Affiliation': 'Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lei', 'Affiliation': 'Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Li', 'Affiliation': 'Aier School of Ophthalmology, Central South University, Wuhan Aier Eye Hospital, Wuhan 430061, China.'}, {'ForeName': 'X T', 'Initials': 'XT', 'LastName': 'Li', 'Affiliation': 'Aier School of Ophthalmology, Central South University, Wuhan Aier Eye Hospital, Wuhan 430061, China.'}]",[Zhonghua yan ke za zhi] Chinese journal of ophthalmology,['10.3760/cma.j.cn112142-20191113-00571']
1780,32847320,[Safety and efficacy of bivalirudin versus unfractionated heparin during perioperative period of percutaneous coronary intervention].,"Objective:  To compare the safety and efficacy of bivalirudin versus unfractionated heparin during perioperative period of percutaneous coronary intervention(PCI) in real-world.  Methods:  A total of 13 097 serial patients who underwent PCI from January 2016 to November 2018 in the Northern Theater Command were enrolled in the present study. Patients were stratified as the bivalirudin group or the heparin group according to antithrombotic therapy during PCI. The primary efficiency endpoint was 30-day net adverse clinical event(NACE), defined as all-cause death, re-infarction, urgent target lesion revascularization (uTLR), stroke or any bleeding. The second efficiency endpoint was 30-day major cardiac and cerebral events (MACCE), defined as all-cause death, re-infarction, uTLR and stroke. Additional end points included the rates of stent thrombosis at 30 days. Propensity scores included clinical and demographic variables, with 1∶2 matching. Compared the incidence of events above between the two groups before and after matching.  Results:  Among the 13 097 included patients(age was (61±10) years old), 3 421 (26.1%) were female. And 2 734 patients were divided into the bivalirudin group, and 10 363 patients to the heparin group(5 468 after matching). Before propensity score matching, patients in bivalirudin group were older and received higher levels of CRUSADE score than heparin group. These patients were more likely to have hypertension and more with ST-segment elevation acute coronary syndromes（all  P ＜0.05）. After propensity score matching, the incidence of 30-day NACE(3.8%(103/2 734) vs.5.0%(271/5 468),  P =0.015) and any bleeding (2.0%(54/2 734) vs. 2.8%(151/5 468),  P =0.032) in the bivalirudin group were lower than that in the heparin group, but the incidence of MACCE (1.9%(51/2 734) vs. 2.3%(127/5 468),  P =0.180) and stent thrombosis (0.1%(2/2 734) vs. 0.1%(3/5 468),  P =1.000) were comparable between the two groups.  Conclusion:  The risk of bleeding and the incidence of NACE are significantly lower for patients using bivalirudin during perioperative period of PCI compared to heparin, without significant differences in ischemic events.",2020,These patients were more likely to have hypertension and more with ST-segment elevation acute coronary syndromes（all  P ＜0.05）.,"['And 2 734 patients', '13 097 included patients(age was (61±10) years old), 3 421 (26.1%) were female', 'A total of 13 097 serial patients who underwent PCI from January 2016 to November 2018 in the Northern Theater Command were enrolled in the present study', 'group, and 10 363 patients to the']","['antithrombotic therapy', 'heparin', 'bivalirudin', 'unfractionated heparin']","['30-day major cardiac and cerebral events (MACCE), defined as all-cause death, re-infarction, uTLR and stroke', 'safety and efficacy', 'rates of stent thrombosis', 'risk of bleeding and the incidence of NACE', 'stent thrombosis', 'ischemic events', '30-day net adverse clinical event(NACE), defined as all-cause death, re-infarction, urgent target lesion revascularization (uTLR), stroke or any bleeding', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0475307', 'cui_str': 'Theatre'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",13097.0,0.0307312,These patients were more likely to have hypertension and more with ST-segment elevation acute coronary syndromes（all  P ＜0.05）.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'Z Y', 'Initials': 'ZY', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China.'}]",Zhonghua xin xue guan bing za zhi,['10.3760/cma.j.cn112148-20200717-00566']
1781,32848379,Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Moderate-to-Very-Severe COPD.,"Introduction


Long-acting β 2 -agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) are established maintenance bronchodilator treatments for chronic obstructive pulmonary disease (COPD) with the potential to increase heart rate (HR) and impact blood pressure (BP). While previous studies indicate that HR and BP are not negatively influenced by tiotropium or olodaterol monotherapy, the effect of tiotropium/olodaterol has not been evaluated. We report a post hoc analysis of the effect of dual bronchodilation with tiotropium/olodaterol versus monocomponents on HR and BP in patients with moderate-to-very-severe COPD included in the large TONADO ®  study.
Methods


The TONADO ®  trials (1237.5 [NCT01431274] and 1237.6 [NCT01431287]) were two replicate, randomized, double-blind, parallel-group, 52-week, Phase III trials that compared tiotropium/olodaterol (5/5 μg and 2.5/5 μg) with tiotropium (5 μg and 2.5 μg) and olodaterol (5 μg) in patients with moderate-to-very-severe COPD. Patients with cardiovascular comorbidities were included. Changes in HR and systolic/diastolic BP were measured before and after dosing with the study medication at each visit (baseline, Week 12, Week 24 and Week 52).
Results


Overall, 3,100 patients were included in this analysis. Over 52 weeks, small changes from baseline in mean HR (<2 beats per minute [bpm]) and small changes from pre- to post-dose (<1 bpm) were evident at different time points. There was a non-significant increase from baseline in mean diastolic and systolic BP (<2 mmHg) observed over 52 weeks of treatment. The short-term (1 hour pre- to 1 hour post-dose) mean changes in systolic and diastolic BP over 52 weeks in the tiotropium/olodaterol 5/5 µg group were comparable with those observed for the monocomponents at all time points.
Conclusion


There were no differences in HR or BP among patients on tiotropium/olodaterol when compared with monocomponents. This supports the already demonstrated cardiovascular safety profile of tiotropium/olodaterol as long-acting maintenance bronchodilator treatment for COPD, including patients with cardiovascular comorbidities.",2020,There were no differences in HR or BP among patients on tiotropium/olodaterol when compared with monocomponents.,"['Patients with cardiovascular comorbidities were included', '3,100 patients were included in this analysis', 'patients with moderate-to-very-severe COPD included in the large TONADO ®  study', 'patients with moderate-to-very-severe COPD', 'Patients with Moderate-to-Very-Severe COPD', 'chronic obstructive pulmonary disease (COPD', 'patients with cardiovascular comorbidities']","['tiotropium/olodaterol', 'tiotropium/olodaterol versus monocomponents', 'tiotropium', 'Long-acting β 2 -agonists (LABAs) and long-acting muscarinic antagonists (LAMAs', 'Tiotropium/Olodaterol']","['systolic and diastolic BP', 'HR or BP', 'HR and BP', 'Changes in HR and systolic/diastolic BP', 'mean diastolic and systolic BP', 'Long-Term Heart Rate and Blood Pressure', 'heart rate (HR) and impact blood pressure (BP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0999593', 'cui_str': 'Lama'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",3100.0,0.259105,There were no differences in HR or BP among patients on tiotropium/olodaterol when compared with monocomponents.,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Andreas', 'Affiliation': 'Department of Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Lorcan', 'Initials': 'L', 'LastName': 'McGarvey', 'Affiliation': ""Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Bothner', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Trampisch', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Matjaz', 'Initials': 'M', 'LastName': 'Fležar', 'Affiliation': 'Klinika Golnik, Golnik, Slovenia.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Alter', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University of Marburg (UMR), Marburg, Germany, Member of the German Center for Lung Research (DZL).'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S246348']
1782,32848381,A Post Hoc Holter ECG Analysis of Olodaterol and Formoterol in Moderate-to-Very-Severe COPD.,"Background


Patients with chronic obstructive pulmonary disease (COPD) are at risk of developing cardiac arrhythmias and elevated heart rate. A theoretical mechanistic association based on the interaction of long-acting β 2 -agonists (LABAs) with adrenoreceptors in the heart and vasculature is assumed as a potential class-related risk. Therefore, we performed a pooled analysis of Holter electrocardiogram (ECG) data from four 48-week, randomized, double-blind, placebo-controlled, parallel-group, Phase III clinical trials evaluating olodaterol (5 μg or 10 μg) or formoterol (12 µg) versus placebo.
Methods


We analyzed Holter ECG data from a representative subset of 775 patients with Global Initiative for Chronic Obstructive Lung Disease stage 2-4 COPD from four studies (1222.11-14) assessing olodaterol (5 μg and 10 μg) and formoterol (12 µg) versus placebo.
Results


No statistically significant (P>0.3) or clinically relevant differences in the shift from baseline of premature supraventricular or ventricular beats were observed among the active treatment and the placebo groups. Minor and transient differences were observed in the adjusted mean heart rate from baseline during treatment in all groups. There was a numerically small but statistically significant increase for formoterol at Week 24, olodaterol 5 μg at Weeks 12 and 40, and olodaterol 10 μg at Week 40 (all less than 3.0 beats per minute). Mean heart rates returned to a statistically non-significant change at Week 48 for all treatment groups. No increase in major adverse cardiovascular events was observed.
Conclusion


Treatment with olodaterol or formoterol is not associated with arrhythmias or a persistent increase in heart rate as assessed by Holter ECG in patients with COPD.
Trial Registration


ClinicalTrials.gov identifiers: NCT00782210 (1222.11); NCT00782509 (1222.12); NCT00793624 (1222.13); NCT00796653 (1222.14).",2020,"Conclusion


Treatment with olodaterol or formoterol is not associated with arrhythmias or a persistent increase in heart rate as assessed by Holter ECG in patients with COPD.
","['\n\n\nPatients with chronic obstructive pulmonary disease (COPD', '775 patients with Global Initiative for Chronic Obstructive Lung Disease stage 2-4 COPD from four studies (1222.11-14) assessing olodaterol (5 μg and 10 μg) and formoterol (12 µg) versus', 'patients with COPD', 'Moderate-to-Very-Severe COPD']","['olodaterol or formoterol', 'placebo', 'formoterol']","['adjusted mean heart rate', 'premature supraventricular or ventricular beats', 'major adverse cardiovascular events', 'heart rate', 'Mean heart rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4517874', 'cui_str': '775'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",775.0,0.606972,"Conclusion


Treatment with olodaterol or formoterol is not associated with arrhythmias or a persistent increase in heart rate as assessed by Holter ECG in patients with COPD.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Andreas', 'Affiliation': 'Department of Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Bothner', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Kloer', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Trampisch', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Alter', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University of Marburg (UMR), Marburg, Germany, Member of the German Center for Lung Research (DZL).'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S246353']
1783,32852696,Efficacy and Safety of Sitagliptin Compared with Dapagliflozin in People ≥ 65 Years Old with Type 2 Diabetes and Mild Renal Insufficiency.,"INTRODUCTION


Older patients with type 2 diabetes (T2D) are at increased risk of diabetic nephropathy and mild renal insufficiency. This analysis compared the anti-hyperglycemic efficacy and safety of sitagliptin with dapagliflozin in patients ≥ 65 years of age with T2D and mild renal insufficiency.
METHODS


This was a post hoc analysis of data from 410 patients ≥ 65 years old who participated in a 24-week, randomized, double-blind clinical trial (CompoSIT-R [comparison of sitagliptin with dapagliflozin in mild renal impairment]; NCT02532855) in T2D patients with mild renal insufficiency and on metformin ± a sulfonylurea; the primary efficacy end point was change in HbA1c at week 24.
RESULTS


Treatment groups were well balanced at baseline (mean HbA1c = 7.7/7.7% and eGFR = 79/76 ml/min/1.73 m 2  for sitagliptin/dapagliflozin). At week 24, LS mean (95% CI) change in HbA1c and percentage of patients with HbA1c < 7% were greater with sitagliptin, - 0.48% and 41%, respectively, compared with dapagliflozin, - 0.36% and 28%; between-group differences = - 0.12% (- 0.36, 0.01) and 12.8% (3.3, 22.2) for change in HbA1c and percentage with HbA1c < 7%, respectively. The sitagliptin group had greater reductions in PPG end points, while the dapagliflozin group had greater reductions in FPG. Treatments were generally well tolerated. There were fewer drug-related adverse events (AEs) with sitagliptin than with dapagliflozin but AE profiles were otherwise similar.
CONCLUSIONS


In patients ≥ 65 years of age with T2D and mild renal insufficiency with inadequate glycemic control on metformin ± sulfonylurea, treatment with sitagliptin for 24 weeks resulted in improvement in HbA1c relative to treatment with dapagliflozin that is consistent with that previously observed in the overall population. Both treatments were generally well tolerated.",2020,"There were fewer drug-related adverse events (AEs) with sitagliptin than with dapagliflozin but AE profiles were otherwise similar.
","['patients\u2009≥\u200965\xa0years of age with T2D and mild renal insufficiency with inadequate glycemic control on metformin\u2009±\u2009sulfonylurea, treatment with sitagliptin for 24\xa0weeks', 'T2D patients with mild renal insufficiency and on metformin\u2009±\u2009a', 'Older patients with type 2 diabetes (T2D', '65\xa0years of age with T2D and mild renal insufficiency', 'People\u2009≥', '410 patients\u2009≥', '65 Years Old with Type 2 Diabetes and Mild Renal Insufficiency', '65\xa0years old who participated', 'patients\u2009≥']","['Sitagliptin', 'Dapagliflozin', 'sitagliptin with dapagliflozin', 'sulfonylurea', 'dapagliflozin']","['FPG', 'tolerated', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.192702,"There were fewer drug-related adverse events (AEs) with sitagliptin than with dapagliflozin but AE profiles were otherwise similar.
","[{'ForeName': 'Annaswamy', 'Initials': 'A', 'LastName': 'Raji', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. annaswamy.raji@merck.com.'}, {'ForeName': 'Zhi Jin', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Raymond L H', 'Initials': 'RLH', 'LastName': 'Lam', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': ""O'Neill"", 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Kaufman', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Engel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00907-w']
1784,32861806,Osimertinib versus platinum-pemetrexed for patients with EGFR T790M advanced NSCLC and progression on a prior EGFR-tyrosine kinase inhibitor: AURA3 overall survival analysis.,"BACKGROUND


In AURA3 (NCT02151981), osimertinib, a third-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), significantly prolonged progression-free survival and improved response in patients with EGFR T790M advanced non-small-cell lung cancer (NSCLC) and progression on prior EGFR-TKI treatment. We report the final AURA3 overall survival (OS) analysis.
PATIENTS AND METHODS


Adult patients were randomized 2 : 1 to osimertinib (80 mg orally, once daily) or pemetrexed plus carboplatin/cisplatin (platinum-pemetrexed) intravenously, every 3 weeks (≤6 cycles). Patients could crossover to osimertinib on progression confirmed by blinded independent central review. OS and safety were secondary end points.
RESULTS


A total of 279 patients were randomly assigned to receive osimertinib and 140 to platinum-pemetrexed (136 received treatment). At data cut-off (DCO; 15 March 2019), 188 patients (67%) receiving osimertinib versus 93 (66%) receiving platinum-pemetrexed had died. The hazard ratio (HR) for OS was 0.87 [95% confidence interval (CI) 0.67-1.12; P = 0.277]; the median OS was 26.8 months (95% CI 23.5-31.5) versus 22.5 months (95% CI 20.2-28.8) for osimertinib and platinum-pemetrexed, respectively. The estimated 24- and 36-month survival was 55% versus 43% and 37% versus 30%, respectively. After crossover adjustment, there was an HR of 0.54 (95% CI 0.18-1.6). Time to first subsequent therapy or death showed a clinically meaningful advantage toward osimertinib (HR 0.21, 95% CI 0.16-0.28; P < 0.001). At DCO, 99/136 (73%) patients in the platinum-pemetrexed arm had crossed over to osimertinib, 66/99 (67%) of whom had died. The most common adverse events possibly related to study treatment were diarrhea (32%; grade ≥3, 1%) and rash (grouped term; 32%; grade ≥3, <1%) in the osimertinib arm, versus nausea (47%; grade ≥3, 3%) in the platinum-pemetrexed arm.
CONCLUSIONS


In patients with T790M advanced NSCLC, no statistically significant benefit in OS was observed for osimertinib versus platinum-pemetrexed, which possibly reflects the high crossover rate of patients from platinum-pemetrexed to osimertinib.
CLINICAL TRIALS NUMBER


ClinicalTrials.gov NCT02151981; https://clinicaltrials.gov/ct2/show/NCT02151981.",2020,"The estimated 24- and 36-month survival was 55% versus 43% and 37% versus 30%, respectively.","['Adult patients', 'patients with EGFR T790M advanced non-small-cell lung cancer (NSCLC) and progression on prior EGFR-TKI treatment', '279 patients were randomized to osimertinib and 140 to', 'patients with EGFR T790M advanced NSCLC and progression on a prior EGFR-tyrosine kinase inhibitor']","['osimertinib', 'Osimertinib versus platinum-pemetrexed', 'pemetrexed plus carboplatin/cisplatin (platinum-pemetrexed', 'platinum-pemetrexed']","['diarrhea', 'OS and safety', 'final AURA3 overall survival (OS) analysis', 'rash', 'nausea', 'hazard ratio (HR) for OS', 'median OS', 'estimated 24- and 36-month survival', 'OS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",279.0,0.231177,"The estimated 24- and 36-month survival was 55% versus 43% and 37% versus 30%, respectively.","[{'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Papadimitrakopoulou', 'Affiliation': 'Department of Thoracic Head and Neck Medical Oncology, The University of Texas, MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Mok', 'Affiliation': ""State Key Laboratory of Translational Oncology, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Center for Lung Cancer, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Delmonte', 'Affiliation': 'Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University School of Medicine Winship Cancer Institute, Atlanta, USA.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Ontario, Canada; Department of Medical Oncology and Hematology, The University of Toronto, Ontario, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Laskin', 'Affiliation': 'Department of Medicine, BC Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Respiratory Disease, Daping Hospital, Chongqing, People's Republic of China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Akamatsu', 'Affiliation': 'Internal Medicine III, Wakayama Medical University Hospital, Wakayama, Japan.'}, {'ForeName': 'W S M E', 'Initials': 'WSME', 'LastName': 'Theelen', 'Affiliation': 'Department of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'W-C', 'Initials': 'WC', 'LastName': 'Su', 'Affiliation': 'Department of Oncology, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'John', 'Affiliation': 'Department of Medical Oncology, Olivia Newton-John Cancer Research Institute, Austin Health, Melbourne, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sebastian', 'Affiliation': 'Department of Medicine, Hematology and Oncology, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mann', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miranda', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Laus', 'Affiliation': 'Global Medicines Development, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Rukazenkov', 'Affiliation': 'Global Medicines Development, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Y-L', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China. Electronic address: syylwu@live.cn.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.08.2100']
1785,32835925,Efficacy of donepezil for the attenuation of memory deficits associated with electroconvulsive therapy.,"We sought to confirm and extend the findings of studies that reported that acetylcholinesterase inhibitor drugs protect against electroconvulsive therapy (ECT)-induced cognitive impairment. We randomized 30 patients with depression (n=24) or schizophrenia (n=6) to receive either donepezil (10 mg/day; n=15) or placebo (n=15) during a fixed course of 6 thrice-weekly, modified, bifrontotemporal sine wave ECT, and for 30 days subsequently. We assessed memory using the Postgraduate Institute Memory Scale (PGI-MS) at baseline, and again at days 2, 7, and 30 after the ECT course. At baseline, memory functioning was comparable in the 2 groups. At 2 days post-ECT, memory functioning was impaired on almost all 10 subtests and on the total scale. At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself. There was no significant difference between groups in the primary outcome, improvement in PGI-MS scores between Days 2 and 30 post-ECT. On almost all subtests, also, there was no significant difference between groups. In summary, we found that donepezil (10 mg/day) did not improve memory outcomes after ECT.",2020,"At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself.",['30 patients with depression (n=24) or schizophrenia (n=6) to receive either'],"['donepezil', 'placebo', 'electroconvulsive therapy']","['Postgraduate Institute Memory Scale (PGI-MS', 'memory outcomes', 'PGI-MS scores', 'memory functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.109804,"At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself.","[{'ForeName': 'Lt Col Bikram', 'Initials': 'LCB', 'LastName': 'Dutta', 'Affiliation': 'Department of Child and Adolescent Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, India.'}, {'ForeName': 'Col Pradyot', 'Initials': 'CP', 'LastName': 'Sarkar', 'Affiliation': 'Ohio Hospital, New Town, Kolkata, India. Electronic address: colpsarkar@live.com.'}, {'ForeName': 'Chittaranjan', 'Initials': 'C', 'LastName': 'Andrade', 'Affiliation': 'Dean (Basic Sciences), Department of Clinical Psychopharmacology and Neurotoxicology, National Institute of Mental Health and Neurosciences, Bangalore 560 029, India. Electronic address: andradec@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113397']
1786,32835958,Enhancing extinction with response prevention via imagery-based counterconditioning: Results on conditioned avoidance and distress.,"BACKGROUND AND OBJECTIVES


Maladaptive avoidance is a core characteristic of anxiety-related disorders. Its reduction is often promoted using extinction with response prevention (ExRP) procedures, but these effects are often short-lived. Research has shown that pairing a feared stimulus with a stimulus of an incompatible valence (i.e., counterconditioning) may be effective in reducing fear. This laboratory study tested whether positive imagery during ExRP (i.e., imagery counterconditioning protocol) can also reduce avoidance.
METHODS


In the counterconditioning procedure, participants imagined a positive sound. There were four phases. First, participants were presented with squares on a computer screen of which one (CS+) was paired with an aversive sound and another (CS-) was not. Second, they learned to avoid the negative sound in the presence of the CS+, via a key press. Third, they were assigned to either the Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP). Finally, they performed a test phase that consisted of two parts: in the first part, avoidance responses were available for each CS and in the second part, these responses were prevented.
RESULTS


The Counterconditioning intervention resulted in a short-lived reduction of distress associated with the CS+. However, groups did not differ in avoidance or distress during the test phases.
LIMITATIONS


US-expectancy ratings were collected only at the end of the experiment.
CONCLUSIONS


The results indicate that positive imagery during ExRP may be effective in reducing distress during the intervention. Explanations for the persistence of avoidance and fear are discussed.",2020,"However, groups did not differ in avoidance or distress during the test phases.
",[],['Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP'],"['avoidance or distress', 'distress']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.037803,"However, groups did not differ in avoidance or distress during the test phases.
","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Hendrikx', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}, {'ForeName': 'Angelos-Miltiadis', 'Initials': 'AM', 'LastName': 'Krypotos', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands; Department of Healthy Psychology, KU Leuven, Belgium. Electronic address: amkrypotos@gmail.com.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101601']
1787,32841892,Identifying subgroups within a sample of adults with a suicide attempt history using the Interpersonal Psychological Theory of Suicide.,"This study used a novel theory-informed latent class approach, based on the Interpersonal Psychological Theory of Suicide (IPTS), to identify subgroups of individuals with a suicide attempt history. The identification of subgroups can inform treatments that target these specific subgroups. Using data from a randomised controlled trial, latent class analysis was conducted on 227 adults with a suicide attempt history. Latent classes were identified based on suicide attempt history, perceived burdensomeness, thwarted belongingness, and capability for suicide at the trial baseline. Three classes were found. Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants). Class 1 had elevated suicidal ideation for the duration of the trial. Classes 1 and 2 also had elevated interpersonal risks relative to a population-based sample. These results suggest that some individuals with a suicide attempt history exhibit relatively low interpersonal risks, and given concurrent protective psychological factors, may be suited to low-intensity interventions. At the other extreme, some individuals with a suicide attempt history require high-intensity interventions addressing interpersonal risks, clinical symptoms, and protective psychological factors.",2020,"Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants).","['individuals with a suicide attempt history', 'Identifying subgroups within a sample of adults with a suicide attempt history using the Interpersonal Psychological Theory of Suicide', '227 adults with a suicide attempt history']",[],"['elevated suicidal ideation', 'interpersonal risks and clinical symptoms, and lower protective psychological factors']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033906', 'cui_str': 'Psychological Theories'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}]",227.0,0.0482775,"Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants).","[{'ForeName': 'Quincy J J', 'Initials': 'QJJ', 'LastName': 'Wong', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia; School of Psychology, Western Sydney University, Sydney, NSW, Australia. Electronic address: q.wong@westernsydney.edu.au.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Torok', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Bregje A J', 'Initials': 'BAJ', 'LastName': 'van Spijker', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Calear', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}]",Psychiatry research,['10.1016/j.psychres.2020.113406']
1788,32841904,Hyperarousal symptoms and perceived burdensomeness interact to predict suicidal ideation among trauma-exposed individuals.,"The association between posttraumatic stress disorder (PTSD) and suicidal ideation is well-established and recent prospective studies have demonstrated the unique role of hyperarousal symptoms. In particular, over-arousal may elevate suicide risk in the presence of interpersonal vulnerability factors including thwarted belongingness, perceived burdensomeness, and acquired capability. Therefore, the current study sought to examine the differential associations between PTSD symptom clusters and suicidality and the impact of interpersonal risk factors. Trauma-exposed adults (N = 247) completed a questionnaire battery at baseline and three-month follow-up, as part of a larger randomized controlled trial of computerized interventions for suicide risk. Given the focus of the current study, treatment condition was controlled for in all analyses. Results indicated that hyperarousal symptoms significantly predict suicidality, while reexperiencing and avoidance symptoms do not. Specifically, greater hyperarousal symptoms predicted increased suicidal ideation among individuals with high perceived burdensomeness. Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability. Taken together, findings suggest that assessment of hyperarousal symptoms and perceived burdensomeness may serve to identify trauma-exposed individuals at greater risk for suicide. Additionally, these factors may serve as effective intervention targets.",2020,"Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability.",['Trauma-exposed adults (N\xa0=\xa0247) completed a'],['questionnaire battery at baseline and three-month follow-up'],"['hyperarousal symptoms', 'suicidal ideation', 'Hyperarousal symptoms']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",247.0,0.0289762,"Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability.","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Morabito', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA. Electronic address: Morabito@psy.fsu.edu.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Boffa', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Carter E', 'Initials': 'CE', 'LastName': 'Bedford', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Jimmy P', 'Initials': 'JP', 'LastName': 'Chen', 'Affiliation': 'Furman University, 3300 Poinsett Hwy, Greenville, SC, USA, 29613.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.029']
1789,32844557,Cardiorenal outcomes with dapagliflozin by baseline glucose-lowering agents: Post hoc analyses from DECLARE-TIMI 58.,"AIM


To assess the associations between baseline glucose-lowering agents (GLAs) and cardiorenal outcomes with dapagliflozin versus placebo in the DECLARE-TIMI 58 study.
MATERIALS AND METHODS


DECLARE-TIMI 58 assessed the cardiorenal outcomes of dapagliflozin versus placebo in patients with type 2 diabetes. This post hoc analysis elaborates the efficacy and safety outcomes by baseline GLA for treatment effect and GLA-based treatment interaction.
RESULTS


At baseline, 14 068 patients (82.0%) used metformin, 7322 (42.7%) sulphonylureas, 2888 (16.8%) dipeptidyl peptidase-4 inhibitors, 750 (4.4%) glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and 7013 (40.9%) insulin. Dapagliflozin reduced the composite of cardiovascular death (CVD) and hospitalization for heart failure (HHF) versus placebo regardless of baseline GLA, with greater benefit in the small group of patients with baseline use of GLP-1 RAs (HR [95% CI] 0.37 [0.18, 0.78] vs. 0.86 [0.75, 0.98] in GLP-1 RA users vs. non-users, P interaction  = .03). The overall HR for major adverse cardiovascular events (CVD, myocardial infarction or ischaemic stroke) was 0.93 (95% CI 0.84, 1.03) with dapagliflozin versus placebo, with no interaction by baseline GLA (P interaction  > .05). The renal-specific outcome was reduced with dapagliflozin versus placebo in the overall cohort (HR [95%CI] 0.53[0.43-0.66]), with no interaction by baseline GLA (P interaction  > .05). All of these outcomes were similar in those with versus those without baseline metformin use.
CONCLUSIONS


The effects of dapagliflozin on cardiorenal outcomes were generally consistent regardless of baseline GLA, with consistent benefits regardless of baseline metformin use. The potential clinical benefit of combining sodium-glucose co-transporter-2 inhibitors with GLP-1 RAs, given some evidence of cardiovascular risk reduction with both classes, should be explored further.",2020,"Dapagliflozin reduced the composite of cardiovascular death and hospitalization for heart failure (CVD/HHF) vs. placebo regardless of baseline GLA, with greater benefit in the small group of patients with baseline use of GLP-1 RA (HR [95% CI] 0.37[0.18, 0.78] vs. 0.86[0.75,0.98] in GLP-1 RA users vs. non-users, p interaction  =0.03).",['patients with type 2 diabetes'],"['GLP-1 receptor agonists (GLP-1 RA', 'dapagliflozin vs. placebo', 'metformin', 'Dapagliflozin', 'dapagliflozin vs placebo', 'SGLT-2 inhibitors with GLP-1 RA', 'dapagliflozin']","['cardiorenal outcomes', 'renal specific outcome', 'composite of cardiovascular death and hospitalization for heart failure', 'overall HR for major adverse cardiovascular events (CVD, myocardial infarction or ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]",,0.300753,"Dapagliflozin reduced the composite of cardiovascular death and hospitalization for heart failure (CVD/HHF) vs. placebo regardless of baseline GLA, with greater benefit in the small group of patients with baseline use of GLP-1 RA (HR [95% CI] 0.37[0.18, 0.78] vs. 0.86[0.75,0.98] in GLP-1 RA users vs. non-users, p interaction  =0.03).","[{'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Yanuv', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Rozenberg', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Jerusalem, Israel.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Department of Medicine, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, and Parkland Health and Hospital System, Dallas, Texas.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Litwak', 'Affiliation': 'Endocrinology Unit, Diabetes Section, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Kooy', 'Affiliation': 'University Medical Center Groningen and Bethesda Diabetes Research Center, Groningen, the Netherlands.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Jerusalem, Israel.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14179']
1790,32845087,Implicit and Explicit Anti-Fat Attitude Change Following Brief Cognitive Dissonance Intervention for Weight Stigma.,"OBJECTIVE


Research has demonstrated that explicit anti-fat attitudes decrease immediately following a brief cognitive dissonance-based intervention targeting weight stigma. The current study explores changes in explicit and implicit anti-fat attitudes immediately following a cognitive dissonance-based weight stigma intervention and 1 week after.
METHODS


College students (N = 156) were randomly assigned to a control or dissonance weight stigma intervention. Weight stigma attitudes were assessed at three time points, and participants completed a measure of values at baseline. Participants in the dissonance condition were told that they had anti-fat attitudes that were inconsistent with their values, whereas participants in the control group were told that their attitudes aligned with their values. All participants reviewed feedback at a follow-up visit before completing explicit and implicit weight stigma assessments a final time.
RESULTS


Individuals in the dissonance condition reported statistically significant decreases in explicit attitudes from Visit 1 to Visit 3. In contrast, there was not a significant condition by time interaction on implicit attitudes.
CONCLUSIONS


This study provides support for cognitive dissonance-based interventions to reduce explicit, but not implicit, anti-fat attitudes following repeated exposure to dissonance induction.",2020,"RESULTS


Individuals in the dissonance condition reported statistically significant decreases in explicit attitudes from Visit 1 to Visit 3.",['College students (N\u2009=\u2009156'],"['control or dissonance weight stigma intervention', 'Implicit and Explicit Anti-Fat Attitude Change Following a Brief Cognitive Dissonance Intervention', 'cognitive dissonance-based weight stigma intervention']","['explicit attitudes', 'Weight stigma attitudes']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0235187', 'cui_str': 'Attitude changed'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]",156.0,0.0164691,"RESULTS


Individuals in the dissonance condition reported statistically significant decreases in explicit attitudes from Visit 1 to Visit 3.","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Breithaupt', 'Affiliation': 'Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Trojanowski', 'Affiliation': 'Department of Psychology, George Mason University, Fairfax, Virginia, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': 'Department of Psychology, George Mason University, Fairfax, Virginia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22909']
1791,32843372,Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


Expanded hemodialysis therapy enabled by medium cut-off membranes may promote greater clearance of larger middle molecules that comprise putative uremic solutes than conventional high-flux dialysis. This randomized trial evaluated the efficacy and safety of hemodialysis treatment with a medium cut-off dialyzer.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Clinically stable patients on maintenance hemodialysis were randomized to receive dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H) over 24 weeks of treatment. The primary safety end point was the predialysis serum albumin level after 24 weeks of treatment. The primary efficacy end point was the reduction ratio of free  λ  light chains at 24 weeks of treatment.
RESULTS


Among 172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years. Of the 86 patients randomized to each dialyzer, 65 completed the trial in each group. The reduction ratio for the removal of free  λ  light chains was significantly higher in the Theranova 400 group compared with the Elisio-17H group after 4 weeks (39% versus 20%) and 24 weeks (33% versus 17%; both  P <0.001). Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin ( P <0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.
CONCLUSIONS


Hemodialysis therapy with the Theranova 400 dialyzer provides superior removal of larger middle molecules, as exemplified by free  λ  light chains, compared with a similar size high-flux dialyzer, while maintaining serum albumin level.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


A Multi-Center, Prospective, Randomized, Controlled, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer in End Stage Renal Disease (ESRD) Patients, NCT03257410.",2020,"Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin ( P <0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.
","['86 patients randomized to each dialyzer, 65 completed the trial in each group', '172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years', 'Clinically stable patients on maintenance hemodialysis']","['Elisio-17H', 'dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H', 'Expanded Hemodialysis with the Theranova 400 Dialyzer', 'hemodialysis treatment with a medium cut-off dialyzer']","['reduction ratio for the removal of free  λ  light chains', 'complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin', 'efficacy and safety', 'Safety and Efficacy', 'predialysis serum albumin level', 'Efficacy and Safety', 'reduction ratio of free  λ  light chains', 'IL-6. Predialysis serum albumin levels', 'predialysis serum albumin levels', 'larger reduction ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0033457', 'cui_str': 'Complement factor D'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",86.0,0.0677605,"Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin ( P <0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.
","[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Tufts Medical Center, Medicine, Nephrology, Boston, Massachusetts.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Falzon', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, San Gwann, Malta luke_falzon@baxter.com.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Skoufos', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}, {'ForeName': 'Angelito', 'Initials': 'A', 'LastName': 'Bernardo', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Beck', 'Affiliation': 'Baxter International Inc., Worldwide Medical, Hechingen, Germany.'}, {'ForeName': 'Mengqi', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}, {'ForeName': 'Ha', 'Initials': 'H', 'LastName': 'Tran', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.01210120']
1792,32843374,Changes in Blood Pressure and Arterial Hemodynamics following Living Kidney Donation.,"BACKGROUND AND OBJECTIVES


The Effect of a Reduction in GFR after Nephrectomy on Arterial Stiffness and Central Hemodynamics (EARNEST) study was a multicenter, prospective, controlled study designed to investigate the associations of an isolated reduction in kidney function on BP and arterial hemodynamics.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Prospective living kidney donors and healthy controls who fulfilled criteria for donation were recruited from centers with expertise in vascular research. Participants underwent office and ambulatory BP measurement, assessment of arterial stiffness, and biochemical tests at baseline and 12 months.
RESULTS


A total of 469 participants were recruited, and 306 (168 donors and 138 controls) were followed up at 12 months. In the donor group, mean eGFR was 27 ml/min per 1.73 m 2  lower than baseline at 12 months. Compared with baseline, at 12 months the mean within-group difference in ambulatory day systolic BP in donors was 0.1 mm Hg (95% confidence interval, -1.7 to 1.9) and 0.6 mm Hg (95% confidence interval, -0.7 to 2.0) in controls. The between-group difference was -0.5 mm Hg (95% confidence interval, -2.8 to 1.7;  P =0.62). The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls. The between-group difference was 0.1 m/s (95% confidence interval, -0.2 to 0.3;  P =0.49).
CONCLUSIONS


Changes in ambulatory peripheral BP and pulse wave velocity in kidney donors at 12 months after nephrectomy were small and not different from controls.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


NCT01769924 (https://clinicaltrials.gov/ct2/show/NCT01769924).",2020,"The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls.","['Prospective living kidney donors and healthy controls who fulfilled criteria for donation were recruited from centers with expertise in vascular research', 'A total of 469 participants were recruited, and 306 (168 donors and 138 controls', 'Living Kidney Donation']",[],"['ambulatory peripheral BP and pulse wave velocity', 'Blood Pressure and Arterial Hemodynamics', 'ambulatory day systolic BP', 'mean eGFR', 'pulse wave velocity']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}]",[],"[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",469.0,0.332628,"The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls.","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Price', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom annaprice@doctors.org.uk.'}, {'ForeName': 'George H B', 'Initials': 'GHB', 'LastName': 'Greenhall', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Moody', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Steeds', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Mark', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Edwards', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Manvir K', 'Initials': 'MK', 'LastName': 'Hayer', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Pickup', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Radhakrishnan', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Law', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Banerjee', 'Affiliation': ""Renal and Transplantation Unit, St George's University Hospitals National Health Service Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Campbell', 'Affiliation': 'Manchester Royal Infirmary, Manchester, United Kingdom.'}, {'ForeName': 'Charles R V', 'Initials': 'CRV', 'LastName': 'Tomson', 'Affiliation': 'Southmead Hospital, Bristol, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Cockcroft', 'Affiliation': 'Department of Cardiology, Wales Heart Research Institute, University Hospital, Cardiff, United Kingdom.'}, {'ForeName': 'Badri', 'Initials': 'B', 'LastName': 'Shrestha', 'Affiliation': 'Sheffield Kidney Institute, Sheffield Teaching Hospitals National Health Service Foundation Trust, Sheffield, United Kingdom.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': ""Cambridge Clinical Trials Unit, Clinical School, Addenbrooke's Hospital, University of Cambridge, Cambridge, United Kingdom.""}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Tomlinson', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ferro', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Townend', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.15651219']
1793,32847776,Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial.,"OBJECTIVE


Duloxetine has been recently used as a part of multimodal analgesia in perioperative settings, yet the optimal dose of Duloxetine is not determined.
DESIGN


A parallel, randomized, placebo-controlled trial.
SETTING


Tertiary level oncology center.
PATIENTS


88 female patients with breast cancer were subjected to modified radical mastectomy (MRM) with ASA class I and II were recruited.
INTERVENTION


Participants were randomly allocated into 4 equal groups received 2 h preoperatively, placebo (D0, N = 22), Duloxetine 30 mg (D30, N = 22), Duloxetine 60 mg (D60, N = 22) and Duloxetine 90 mg (D90, N = 22) tablet.
MEASUREMENTS


The primary outcome; 24 h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting) were measured.
RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
CONCLUSION


Preoperative oral Duloxetine of 60 mg, for patients subjected to MRM is the optimal dose considering its analgesic efficacy and side effects.
TRIAL REGISTRATION


The trial was registered at Clinical Trials.gov with unique ID number; NCT03468348.",2020,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","['88 female patients with breast cancer', 'patients undergoing modified radical mastectomy', 'Tertiary level oncology center']","['Duloxetine', 'modified radical mastectomy (MRM) with ASA class', '2\xa0h preoperatively, placebo', 'Duloxetine 30\xa0mg (D30, N\xa0=\xa022), Duloxetine 60\xa0mg (D60, N\xa0=\xa022) and Duloxetine 90\xa0mg (D90, N\xa0=\xa022) tablet', 'placebo', 'morphine', 'Preoperative Duloxetine']","['level of sedation', 'analgesic efficacy and side effects', '24\xa0h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting', 'vomiting', 'median (IQR) consumption', 'acute pain and quality of recovery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1616501', 'cui_str': 'duloxetine 30 MG [Cymbalta]'}, {'cui': 'C1667738', 'cui_str': 'duloxetine 60 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",88.0,0.273346,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","[{'ForeName': 'Diab Fuad', 'Initials': 'DF', 'LastName': 'Hetta', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Nourhan Alaa', 'Initials': 'NA', 'LastName': 'Elgalaly', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Helal F', 'Initials': 'HF', 'LastName': 'Hetta', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Department of Medical Microbiology and Immunology, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: Helal.hetta@uc.edu.'}, {'ForeName': 'Montaser A', 'Initials': 'MA', 'LastName': 'Fattah Mohammad', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110007']
1794,32852282,Improving Retention in Care and Promoting Adherence to HIV Treatment: Protocol for a Multisite Randomized Controlled Trial of Mobile Phone Text Messaging.,"BACKGROUND


The World Health Organization has prioritized the use of new technologies to assist in health care delivery in resource-limited settings. Findings suggest that the use of SMS on mobile phones is an advantageous application in health care delivery, especially in communities with an increasing use of this device.
OBJECTIVE


The main aim of this trial is to assess whether sending weekly motivational text messages (SMS) through mobile phones versus no text messaging will improve retention in care and promote adherence to treatment and health outcomes among patients receiving HIV treatment in Fako Division of Cameroon.
METHODS


This is a multisite randomized controlled single-blinded trial. Computer-generated random block sizes shall be used to produce a randomization list. Participants shall be randomly allocated into the intervention and control groups determined by serially numbered sealed opaque envelopes. The 156 participants will either receive the mobile phone text message or usual standard of care. We hypothesize that sending weekly motivational SMS reminders will produce a change in behavior to enhance retention; treatment adherence; and, hence, health outcomes. Participants shall be evaluated and data collected at baseline and then at 2, 4, and 6 months after the launch of the intervention. Text messages shall be sent out, and the delivery will be recorded. Primary outcome measures are retention in care and adherence to treatment. Secondary outcomes are clinical (weight, body mass index), biological (virologic suppression, tuberculosis coinfection), quality of life, treatment discontinuation, and mortality. The analysis shall be by intention-to-treat. Analysis of covariates shall be performed to determine factors influencing outcomes.
RESULTS


Recruitment and random allocation are complete; 160 participants were allocated into 3 groups (52 in the single SMS, 55 in the double SMS, and 53 in the control). Data collection and analysis are ongoing, and statistical results will be available by the end of August 2019.
CONCLUSIONS


The interventions will contribute to an improved understanding of which intervention types can be feasible in improving retention in care and promoting adherence to antiretroviral therapy.
TRIAL REGISTRATION


Pan African Clinical Trial Registry in South Africa PACTR201802003035922; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3035.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15680.",2020,"Findings suggest that the use of SMS on mobile phones is an advantageous application in health care delivery, especially in communities with an increasing use of this device.
","['patients receiving HIV treatment in Fako Division of Cameroon', '156 participants will either receive the']","['sending weekly motivational text messages (SMS) through mobile phones versus no text messaging', 'mobile phone text message or usual standard of care']","['clinical (weight, body mass index), biological (virologic suppression, tuberculosis coinfection), quality of life, treatment discontinuation, and mortality', 'retention in care and adherence to treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",160.0,0.223211,"Findings suggest that the use of SMS on mobile phones is an advantageous application in health care delivery, especially in communities with an increasing use of this device.
","[{'ForeName': 'Elvis Asangbeng', 'Initials': 'EA', 'LastName': 'Tanue', 'Affiliation': 'Department of Public Health and Hygiene, Faculty of Health Sciences, University of Buea, Buea, Cameroon.'}, {'ForeName': 'Dickson Shey', 'Initials': 'DS', 'LastName': 'Nsagha', 'Affiliation': 'Department of Public Health and Hygiene, Faculty of Health Sciences, University of Buea, Buea, Cameroon.'}, {'ForeName': 'Nana Njamen', 'Initials': 'NN', 'LastName': 'Theophile', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Health Sciences, University of Buea, Buea, Cameroon.'}, {'ForeName': 'Jules Clement Nguedia', 'Initials': 'JCN', 'LastName': 'Assob', 'Affiliation': 'Department of Medical Laboratory Sciences, Faculty of Health Sciences, University of Buea, Buea, Cameroon.'}]",JMIR research protocols,['10.2196/15680']
1795,32846328,Factors associated with discontinuation in the drug and placebo groups of trials of second generation antipsychotics for acute schizophrenia: A meta-regression analysis: Discontinuation in antipsychotic trials.,"This study investigated factors associated with discontinuation in double-blind, randomized, placebo-controlled trials (DBRPCTs) of second-generation antipsychotics (SGAs) for acute schizophrenia, with a view to establishing what factors were associated with all-cause discontinuation. 77 eligible studies (96 comparisons; n = 22,678) were included in this study. Thirty-one factors potentially affecting all-cause discontinuation, related to the participants, study design, and drugs, were included in a meta-regression analysis that examined the factors associated with discontinuation rates in treatment and placebo groups and/or the treatment-placebo group difference in discontinuation. Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group. These factors were also associated with the treatment-placebo group difference in discontinuation. Although the risk of weight gain from SGA use was not associated with discontinuation rates in either the treatment or placebo groups, SGAs with a risk of weight gain were associated with a larger treatment-placebo group difference in discontinuation, although the reason is unknown. Factors associated with discontinuation rates in both treatment and placebo groups did not influence the treatment-placebo group difference in discontinuation. The efficacy and the risk of weight gain of SGAs seemed to influence treatment-placebo group difference in discontinuation in DBRPCTs of SGAs for acute schizophrenia.",2020,"Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group.","['acute schizophrenia', '77 eligible studies (96 comparisons; n\xa0=\xa022,678']","['placebo', 'placebo-controlled trials (DBRPCTs) of second-generation antipsychotics (SGAs']","['Positive and Negative Syndrome Scale total scores', 'discontinuation rates', 'smaller response rates', 'weight gain']","[{'cui': 'C0857501', 'cui_str': 'Acute schizophrenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",22678.0,0.223392,"Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group.","[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Kishi', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan. Electronic address: tarok@fujita-hu.ac.jp.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Psychiatry, Jikei University School of Medicine, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sakuma', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Okuya', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Nakao', 'Initials': 'N', 'LastName': 'Iwata', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.08.003']
1796,32846388,A Randomised Controlled Trial Examining the Effects of Self-Compassion Meditations on Women's Body Image.,"Although research has suggested that body image improves following self-compassion meditation training, studies have been limited due to the use of a wait-list control group. This study therefore compared the effects of self-compassion meditations to an active control group. Seventy young adult women (17-35 years) were randomly assigned to receive either self-compassion or nature-focused guided imagery meditations. Over one week, participants engaged in two meditations and completed pre- and post-test measures of trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth. A mixed design analysis of variance revealed a main effect of time; women in both meditation groups demonstrated significant increases in self-compassion and body appreciation, and significant reductions in body shame. No effect was found for appearance-contingent self-worth. There were no interactions or main effects for group. Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations. Common elements between self-compassion and guided imagery may be a mechanism for improving body image. However, further research is warranted to isolate the effects of these meditations from other specific and non-specific treatment effects. (This study was pre-registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001814268).",2020,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","['Seventy young adult women (17-35 years', ""Women's Body Image""]","['Self-Compassion Meditations', 'self-compassion or nature-focused guided imagery meditations']","['self-compassion and body appreciation', 'body shame', 'trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",70.0,0.0359798,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'de Wet', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: a_d088@student.usc.edu.au.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Lane', 'Affiliation': 'Centre for Human Factors and Sociotechnical Systems, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: blane@usc.edu.au.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: kmulgrew@usc.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.07.009']
1797,32854485,Effectiveness of Exercise on the Sequence Effect in Parkinson's Disease.,"OBJECTIVE


To determine the benefits of motor training on the sequence effect (SE), an essential component of bradykinesia in Parkinson's disease (PD).
METHODS


Seven patients with de novo PD participated in this study. The patients performed regular pentagon drawing tests and exercises during four visits. The first two visits occurred before the start of medication, and the last two visits occurred at least six months after the start of medication. We assessed the severity of bradykinesia and SE at each visit and compared the results before and after exercise in both the de novo and treatment conditions.
RESULTS


In the de novo condition, the severity of bradykinesia significantly improved after motor training (p = 0.018), but it did not resolve and only showed a trend of improvement after treatment (p = 0.068). The severity of the SE decreased significantly in the drug-naïve condition (p = 0.028) but not after medication (p = 0.273).
CONCLUSION


Our study suggests that regular motor training may be beneficial for the SE in PD.",2020,"The severity of the SE decreased significantly in the drug-naïve condition (p = 0.028) but not after medication (p = 0.273).
","[""Parkinson's disease (PD"", ""Parkinson's Disease"", 'Seven patients with de novo PD participated in this study']","['motor training', 'Exercise', 'regular motor training']","['severity of bradykinesia and SE', 'severity of the SE', 'severity of bradykinesia']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",7.0,0.017575,"The severity of the SE decreased significantly in the drug-naïve condition (p = 0.028) but not after medication (p = 0.273).
","[{'ForeName': 'Suk Yun', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Neurology, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.'}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.'}]",Journal of movement disorders,['10.14802/jmd.20045']
1798,32855110,"Quantification, epitope mapping and genotype cross-reactivity of hepatitis B preS-specific antibodies in subjects vaccinated with different dosage regimens of BM32.","BACKGROUND


Chronic hepatitis B virus (HBV) infections are a global health problem. There is a need for therapeutic strategies blocking continuous infection of liver cells. The grass pollen allergy vaccine BM32 containing the preS domain of the large HBV surface protein (LHBs) as immunogenic carrier induced IgG antibodies in human subjects inhibiting HBV infection in vitro. Aim of this study was the quantification, epitope mapping and investigation of HBV genotype cross-reactivity of preS-specific antibodies in subjects treated with different dosage regimens of BM32 METHODS: Hundred twenty eight grass pollen allergic patients received in a double-blind, placebo-controlled trial five monthly injections of placebo (aluminum hydroxide, n= 34) or different courses of BM32 (2 placebo + 3 BM32, n= 33; 1 placebo + 4 BM32, n= 30; 5 BM32, n= 31). Recombinant Escherichia coli-expressed preS was purified. Overlapping peptides spanning preS and the receptor-binding sites from consensus sequences of genotypes A-H were synthesized and purified. Isotype (IgM, IgG, IgA, IgE) and IgG subclass (IgG 1 -IgG 4 ) responses to preS and peptides were determined by ELISA at baseline, one and four months after the last injection. IgG 1  and IgG 4  subclass concentrations specific for preS and the receptor-binding site were measured by quantitative ELISA.
FINDINGS


Five monthly injections induced the highest levels of preS-specific IgG consisting mainly of IgG 1  and IgG 4 , with a sum of median preS-specific IgG 1  and IgG 4  concentrations of >135 μg/ml reaching up to 1.8 mg/ml. More than 20% of preS-specific IgG was directed against the receptor-binding site. BM32-induced IgG cross-reacted with the receptor-binding domains from all eight HBV genotypes A-H.
INTERPRETATION


BM32 induces high levels of IgG 1  and IgG 4  antibodies against the receptor binding sites of all eight HBV genotypes and hence might be suitable for therapeutic HBV vaccination.
FUNDING


This study was supported by the PhD program IAI (KPW01212FW), by Viravaxx AG and by the Danube-ARC funded by the Government of Lower Austria. Rudolf Valenta is a recipient of a Megagrant of the Government of the Russian Federation, grant No 14.W03.31.0024.",2020,"Isotype (IgM, IgG, IgA, IgE) and IgG subclass (IgG 1 -IgG 4 ) responses to preS and peptides were determined by ELISA at baseline, one and four months after the last injection.","['subjects vaccinated with different dosage regimens of BM32', 'subjects treated with different dosage regimens of BM32 METHODS', 'Hundred twenty eight grass pollen allergic patients']","['placebo (aluminum hydroxide, n= 34) or different courses of BM32 (2 placebo + 3 BM32, n= 33; 1 placebo', 'placebo', 'Recombinant Escherichia coli-expressed preS']","['Isotype (IgM, IgG, IgA, IgE) and IgG subclass (IgG 1 -IgG 4 ) responses to preS and peptides']","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0021017', 'cui_str': 'Immunoglobulin isotype'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C1275917', 'cui_str': 'Immunoglobulin G subclass'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]",,0.143774,"Isotype (IgM, IgG, IgA, IgE) and IgG subclass (IgG 1 -IgG 4 ) responses to preS and peptides were determined by ELISA at baseline, one and four months after the last injection.","[{'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Tulaeva', 'Affiliation': 'Division of Immunopathology, Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, WähringerGürtel 18-20, 3Q, A-1090 Vienna, Austria; Department of Clinical Immunology and Allergology, I. M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Cornelius', 'Affiliation': 'Division of Immunopathology, Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, WähringerGürtel 18-20, 3Q, A-1090 Vienna, Austria.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Schmutz', 'Affiliation': 'Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'Division of Immunopathology, Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, WähringerGürtel 18-20, 3Q, A-1090 Vienna, Austria.'}, {'ForeName': 'Margarete', 'Initials': 'M', 'LastName': 'Focke-Tejkl', 'Affiliation': 'Division of Immunopathology, Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, WähringerGürtel 18-20, 3Q, A-1090 Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Karaulov', 'Affiliation': 'Department of Clinical Immunology and Allergology, I. M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Henning', 'Affiliation': 'Viravaxx, Vienna, Austria.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Valenta', 'Affiliation': 'Division of Immunopathology, Department of Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, Medical University of Vienna, WähringerGürtel 18-20, 3Q, A-1090 Vienna, Austria; Department of Clinical Immunology and Allergology, I. M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation; NRC Institute of Immunology FMBA of Russia, Moscow, Russian Federation; Karl Landsteiner University of Health Sciences, Krems, Austria. Electronic address: rudolf.valenta@meduniwien.ac.at.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102953']
1799,32856226,"Comparison of Blood Glucose Variability Between Exenatide and Biphasic Insulin Aspart 30 in Chinese Participants with Type 2 Diabetes Inadequately Controlled with Metformin Monotherapy: A Multicenter, Open-Label, Randomized Trial.","INTRODUCTION


To compare blood glucose variability (GV) in Chinese participants with type 2 diabetes mellitus (T2DM) whose blood glucose levels are inadequately controlled with metformin monotherapy after twice-daily exenatide or biphasic insulin aspart 30 (BIAsp30).
METHODS


In this 16-week multicenter, randomized clinical trial, 104 participants were randomized 1:1 to receive exenatide (exenatide group) or BIAsp30 (BIAsp30 group) twice daily. All participants continued metformin treatment. The primary outcome was the change in GV as measured by a continuous glucose monitoring system (CGMS) from baseline to 16 weeks.
RESULTS


At 16 weeks, both the Exenatide and BIAsp30 groups effectively decreased mean glucose (MG), but neither group changed the mean amplitude of glycemic excursion (MAGE), largest amplitude of glycemic excursion (LAGE), mean of daily difference (MODD), or standard deviation of blood glucose (SDBG). The decrease in 2-h post-breakfast glucose excursions was greater in the Exenatide group compared to the BIAsp30 group, with a least square (LS) mean difference [95% CI] of (1.58 [0.53, 2.63]). Exenatide also significantly reduced 2-h post-lunch glucose excursion compared to BIAsp30 (LS mean difference [95% CI], 1.19 [0.18, 2.20]). The Exenatide group had significantly reduced body weight and body mass index (BMI), while the BIAsp30 group had increased weight and had no change in BMI. Both treatments were well tolerated with no serious hypoglycemic events and with fewer identified hypoglycemic events in the Exenatide group than in the BIAsp30 group (5.77% vs. 17.31%, P < 0.01).
CONCLUSION


Although there was no difference in change of GV between Exenatide and BIAsp30, exenatide provided more improvement in postprandial glucose excursion and weight control, without increasing the risk of hypoglycemia in Chinese patients with T2DM whose blood glucose was inadequately controlled with metformin. These findings may provide new options for patients who choose further hypoglycemic treatment, especially in patients with obesity who have large postprandial plasma glucose excursions.
TRIAL REGISTRATION


ClinicalTrials.gov indentifier: NCT02449603.",2020,"Both treatments were well tolerated with no serious hypoglycemic events and with fewer identified hypoglycemic events in the Exenatide group than in the BIAsp30 group (5.77% vs. 17.31%, P < 0.01).
","['104 participants', 'Chinese participants with type 2 diabetes mellitus (T2DM) whose blood glucose levels are inadequately controlled with', 'Chinese patients with T2DM whose blood glucose was inadequately controlled with', 'Chinese Participants with Type 2 Diabetes Inadequately Controlled with', 'patients who choose further hypoglycemic treatment, especially in patients with obesity who have large postprandial plasma glucose excursions']","['exenatide or biphasic insulin aspart 30 (BIAsp30', 'Metformin Monotherapy', 'metformin monotherapy', 'Exenatide', 'Exenatide and Biphasic Insulin Aspart', 'metformin', 'exenatide (exenatide group) or BIAsp30 (BIAsp30 group) twice daily']","['BMI', 'weight', 'change in GV as measured by a continuous glucose monitoring system (CGMS', '2-h post-breakfast glucose excursions', 'tolerated with no serious hypoglycemic events', 'hypoglycemic events', 'risk of hypoglycemia', 'blood glucose variability (GV', 'Blood Glucose Variability', 'mean amplitude of glycemic excursion (MAGE), largest amplitude of glycemic excursion (LAGE), mean of daily difference (MODD), or standard deviation of blood glucose (SDBG', '2-h post-lunch glucose excursion', 'body weight and body mass index (BMI', 'mean glucose (MG', 'postprandial glucose excursion and weight control']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C2003521', 'cui_str': 'insulin aspart, insulin aspart protamine drug combination 30:70'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0356369', 'cui_str': 'Biphasic insulin'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}]",104.0,0.0577427,"Both treatments were well tolerated with no serious hypoglycemic events and with fewer identified hypoglycemic events in the Exenatide group than in the BIAsp30 group (5.77% vs. 17.31%, P < 0.01).
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""Department of Endocrinology, Shaanxi Aerospace Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xinwen', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jianrong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology, Xi'an Chang an Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiling', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Endocrinology, Yan'an People's Hospital, Yan'an, Shaanxi, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ming', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Kaiyan', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Shangluo Central Hospital, Shangluo, Shaanxi, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhufang', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': ""Department of Endocrinology, Xi'an Central Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Qingzhen', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': ""Department of Endocrinology, Xi'an Gaoxin Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China. qiuheji@hotmail.com.""}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00904-z']
1800,32866619,Aerobic exercise training partially reverses the impairment of Nrf2 activation in older humans.,"Nuclear factor erythroid-2-related factor 2 (Nrf2), is an inducible transcription factor that improves redox balance through stimulating antioxidant gene expression. In older humans the Nrf2 response to a single bout of acute exercise is blunted compared to young indicating impaired redox signaling. The purpose of this randomized controlled trial was to investigate if the signaling impairment could be reversed with exercise training in older men and women, while also comparing to young. Young (18-28y, n = 21) and older (≥60y, n = 19) men and women were randomized to 8-week aerobic exercise training (ET; 3 d/wk, 45 min/d) or a non-exercise control group (CON). Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein were measured in PBMCs in response to acute exercise trial (AET; 30-min cycling at 70% VO 2  peak pre- and post-intervention at 7 timepoints (Pre, +10 m, +30 m, +1 h, +4 h, +8 h, +24 h). Young had greater Nrf2 signaling response compared to older at pre-intervention (p = 0.05), whereas the older had significantly higher basal Nrf2 levels (p = 0.004). ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05). The degree of restoration in Nrf2 signaling response was related to the degree of change in basal Nrf2 (p = 0.039), which was driven by older adults (p = 0.014). Lower basal nuclear Nrf2 levels were associated with changes seen in AET responses for Nrf2 and GCLC protein, as well as NQO1 and GCLC mRNA. Together these data demonstrate that exercise training improves Nrf2 signaling and downstream gene expression and that lower basal Nrf2 levels are associated with a more dynamic acute response. Our results provide evidence that the impaired Nrf2 signaling in sedentary older adults can be restored to a degree with moderate exercise training, albeit not to the level seen in young. CLINICALTRIALS.GOV ID: NCT03419988.",2020,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"['sedentary older adults', 'older humans', 'older men and women, while also comparing to young', 'Young (18-28y, n\u202f=\u202f21) and older (≥60y, n\u202f=\u202f19) men and women']","['Aerobic exercise training', 'aerobic exercise training (ET; 3\u202fd/wk, 45\u202fmin/d) or a non-exercise control group (CON', 'exercise training', 'CON']","['Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein', 'Nrf2 signaling response', 'basal Nrf2 levels', 'basal Nrf2 expression', 'impairment of Nrf2 activation', 'Nrf2 signaling and downstream gene expression']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1136197', 'cui_str': 'NAD(P)H dehydrogenase (quinone) 1, human'}, {'cui': 'C0018969', 'cui_str': 'Heme oxygenase (decyclizing)'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}]",,0.0441431,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"[{'ForeName': 'Ethan L', 'Initials': 'EL', 'LastName': 'Ostrom', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA.'}, {'ForeName': 'Tinna', 'Initials': 'T', 'LastName': 'Traustadóttir', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA. Electronic address: tinna.traustadottir@nau.edu.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.08.016']
1801,32866688,Improved neck posture and reduced neck muscle activity when using a novel camera based workstation for manual precision inspection tasks.,"PURPOSE


This study investigates the effects of the usage of a novel camera system compared to a conventional lens system for manual precision tasks. Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
METHODS


Camera and lens systems were compared by assessing the craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion. 16 healthy participants (n = 8 female, 24 ± 2 years; n = 8 male, 30 ± 5 years) performed manual precision tasks in a cross-over design using both systems in sitting and standing positions.
RESULTS


Analyses showed that using the camera system improved the CVA in sitting [28.4° (22.8°-33.9°) to 42.5° (38.9°-46.1°); p < 0.01] and decreased the M.trapezius activity in standing [13.1% (7.7%-18.6%) to 8.65% (5.49%-11.81%)]. Additionally, overall and neck specific perceived exertion decreased when using the camera system in standing.
CONCLUSIONS


The camera system may prevent neck pain in workers performing manual precision tasks in sitting and standing postures.",2020,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","['16 healthy participants (n\xa0=\xa08 female, 24\xa0±\xa02 years; n\xa0=\xa08 male, 30\xa0±\xa05 years) performed']","['manual precision tasks in a cross-over design using both systems in sitting and standing positions', 'novel camera system']","['craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion', 'CVA in sitting', 'Improved neck posture and reduced neck muscle activity', 'M.trapezius activity', 'overall and neck specific perceived exertion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",16.0,0.0296013,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gräf', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mattes', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Psychology and Neuroergonomics, Technical University of Berlin, Fasanenstraße 1, 10623, Berlin, Germany. Electronic address: bettina.wollesen@uni-hamburg.de.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103147']
1802,32870466,The Effects of Mobile-App-Based Low-Carbohydrate Dietary Guidance on Postprandial Hyperglycemia in Adults with Prediabetes.,"INTRODUCTION


Postprandial hyperglycemia is independently associated with many adverse complications, while diets with a low glycemic load are beneficial in improving post-meal glucose levels. This study aims to determine if mobile-app-based low-carbohydrate dietary guidance will reduce exposure to postprandial hyperglycemia in adults with prediabetes.
METHODS


This single-blind, randomized controlled pilot study included 100 participants (39 men; mean age 53.6 ± 11.9 years) and was performed in the PKU Care CNOOC Hospital, China. The intervention group (n = 57) received low-carbohydrate dietary guidance through a moblie app (CAReNA) for 3 months, while the control group (n = 43) only received health education on a diabetic diet. The primary outcome was change in time of postprandial hyperglycemia between baseline and 3 months.
RESULTS


The study revealed that the mean time in postprandial hyperglycemia (> 7.8 mmol/l [140 mg/dl]) monitored by flash glucose monitoring changed from 3.27 h/day at baseline to 2.34 h/day at 3 months in the intervention group and from 3.08 h/day to 2.96 h/day in the control group, with a between-group difference of - 0.81 h/day (P < 0.05). Fasting plasma glucose and glycated hemoglobin (HbA1c) in the intervention group decreased significantly, although no significant difference was seen between the two groups. Compared with the control group, the intervention group had a significant decrease in anthropometric and body composition measurements as well as triglycerides.
CONCLUSION


The mobile-app-based low-carbohydrate dietary guidance effectively reduced the time spent in postprandial hyperglycemia in adults with prediabetes. This new type of nutritional management has beneficial effects on people with prediabetes and needs further research.
CLINICAL TRIAL REGISTRATION


ChiCTR1900024880.",2020,"Fasting plasma glucose and glycated hemoglobin (HbA1c) in the intervention group decreased significantly, although no significant difference was seen between the two groups.","['100 participants (39 men; mean age 53.6\u2009±\u200911.9\xa0years) and was performed in the PKU Care CNOOC Hospital, China', 'Adults with Prediabetes', 'adults with prediabetes']","['low-carbohydrate dietary guidance through a moblie app (CAReNA) for 3 months, while the control group (n\u2009=\u200943) only received health education on a diabetic diet', 'Mobile-App-Based Low-Carbohydrate Dietary Guidance', 'mobile-app-based low-carbohydrate dietary guidance']","['Postprandial Hyperglycemia', 'time spent in postprandial hyperglycemia', 'mean time in postprandial hyperglycemia', 'flash glucose monitoring', 'Fasting plasma glucose and glycated hemoglobin (HbA1c', 'triglycerides', 'anthropometric and body composition measurements', 'change in time of postprandial hyperglycemia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0011878', 'cui_str': 'Diabetic diet'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",100.0,0.0620552,"Fasting plasma glucose and glycated hemoglobin (HbA1c) in the intervention group decreased significantly, although no significant difference was seen between the two groups.","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, TEDA International Cardiovascular Hospital, Cardiovascular Clinical College of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Endocrinology and Nephrology, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kunii', 'Affiliation': 'Department of Food and Nutritional Sciences, Jumonji University, Tokyo, Japan.'}, {'ForeName': 'Kousuke', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Japan Nutrition Care Service Association, Tokyo, Japan.'}, {'ForeName': 'Yiyan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Food and Nutritional Sciences, Jumonji University, Tokyo, Japan.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medicine, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology and Nephrology, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'Department of Endocrinology and Nephrology, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Teng', 'Affiliation': 'Department of Endocrinology and Nephrology, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Nie', 'Affiliation': 'Department of Rehabilitation Medicine, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, PKU Care CNOOC Hospital, Tianjin, China.'}, {'ForeName': 'Kaijun', 'Initials': 'K', 'LastName': 'Niu', 'Affiliation': 'School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medicine, Shanghai University of Medicine and Health Sciences Affiliated Zhoupu Hospital, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Rehabilitation Medicine, Shanghai University of Medicine and Health Sciences Affiliated Zhoupu Hospital, Shanghai, China. guoqijp@gmail.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00906-x']
1803,32870473,Immunotherapy in Breast Cancer: Current Practice and Clinical Challenges.,"Immunotherapy is currently approved for a subset of patients diagnosed with advanced triple negative breast cancer (TNBC), based on the phase III randomized controlled trial, IMpassion130. The anti-programmed cell death ligand-1 (PD-L1) immune checkpoint inhibitor atezolizumab combined with nanoparticle albumin-bound (nab)-paclitaxel is currently the standard first-line therapy in patients with metastatic TNBC who have a PD-L1-positive peritumoral immune infiltrate. Although this approval is limited to only a subset of patients, strategies to expand indications in breast cancer for this treatment modality are being extensively evaluated. A substantial need exists for the identification of patient characteristics, disease settings, immune markers, ideal partners for combination with immune checkpoint inhibitors, and the ideal sequence with traditional anticancer therapies. Additionally, in light of the results of the KEYNOTE-522 study of adjuvant pembrolizumab in TNBC, evaluation of immunotherapy in the early disease setting is a subject of great interest. This review article discusses current knowledge on immune checkpoint inhibitors in clinical practice, and provides an overview of a variety of markers evaluated to predict benefit of immunotherapy and of promising new strategies to enhance immune response and enable more patients to benefit from immunotherapy.",2020,"Although this approval is limited to only a subset of patients, strategies to expand indications in breast cancer for this treatment modality are being extensively evaluated.","['Breast Cancer', 'patients diagnosed with advanced triple negative breast cancer (TNBC', 'patients with metastatic TNBC who have a PD-L1-positive peritumoral immune infiltrate']","['Immunotherapy', 'atezolizumab combined with nanoparticle albumin-bound (nab)-paclitaxel']",[],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]",[],,0.0359073,"Although this approval is limited to only a subset of patients, strategies to expand indications in breast cancer for this treatment modality are being extensively evaluated.","[{'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'de Melo Gagliato', 'Affiliation': 'Centro Oncológico da Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Buzaid', 'Affiliation': 'Centro Oncológico da Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Perez-Garcia', 'Affiliation': 'IOB Institute of Oncology, Quiron Group, Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': 'IOB Institute of Oncology, Quiron Group, Barcelona, Spain. jacortes@vhio.net.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00436-9']
1804,32876780,Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis.,"BACKGROUND/OBJECTIVES


ABP 798 is a proposed biosimilar to the originator biologic rituximab, an anti-CD20 monoclonal antibody. This comparative clinical study evaluated the pharmacokinetics (PK), safety, and efficacy of ABP 798 versus rituximab reference product (RP) in patients with moderate-to-severe rheumatoid arthritis (RA).
METHODS


Adults with moderate-to-severe RA with an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs including 1 or more tumor necrosis factor inhibitor therapies (n = 311) received ABP 798, US-sourced rituximab RP (rituximab US), or EU-sourced rituximab RP (rituximab EU) (1000 mg, 2 weeks apart). At week 24, ABP 798- or rituximab EU-treated subjects received a second dose of the same treatment, while rituximab US-treated subjects transitioned to receive ABP 798. The key efficacy endpoint was DAS28-CRP change from baseline at week 24. Other efficacy endpoints included DAS28-CRP at other time points; ACR20, ACR50, and ACR70 criteria; and hybrid ACR. The rituximab RP groups were pooled for all efficacy endpoints since PK equivalence had been established between rituximab US and rituximab EU.
RESULTS


Clinical equivalence between ABP 798 and rituximab RP was established as the 90% confidence interval for DAS28-CRP change from baseline at week 24 fell within the prespecified equivalence margin (- 0.6, 0.6). Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
CONCLUSIONS


Clinical equivalence in terms of efficacy, safety, and immunogenicity was established between ABP 798 and rituximab RP in this comparative clinical trial in patients with moderate-to-severe RA. Key Points • ABP 798 provided similar efficacy as rituximab reference product (RP) in patients with moderate-severe rheumatoid arthritis. • The safety and immunogenicity profiles for ABP 798 were similar to those for the rituximab RP. • The single transition from rituximab RP to ABP 798 did not show differences in efficacy, safety, or immunogenicity.",2020,"Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
","['patients with moderate-to-severe RA', 'patients with moderate-severe rheumatoid arthritis', 'Adults with moderate-to-severe RA with an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs including 1 or more tumor necrosis factor inhibitor therapies (n\u2009=\u2009311) received', 'subjects with moderate-to-severe rheumatoid arthritis', 'patients with moderate-to-severe rheumatoid arthritis (RA']","['ABP 798 versus rituximab reference product (RP', 'biosimilar ABP 798 with rituximab reference product', 'rituximab US-treated subjects transitioned to receive ABP 798', 'ABP 798, US-sourced rituximab RP (rituximab US), or EU-sourced rituximab RP (rituximab EU']","['efficacy, safety, and immunogenicity', 'DAS28-CRP at other time points; ACR20, ACR50, and ACR70 criteria; and hybrid ACR', 'pharmacokinetics (PK), safety, and efficacy', 'Safety and immunogenicity profiles', 'Efficacy and safety', 'efficacy, safety, or immunogenicity', 'safety and immunogenicity profiles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003191', 'cui_str': 'Antirheumatic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0484735,"Safety and immunogenicity profiles of ABP 798 were comparable across treatment groups and not affected by single transition from RP to ABP 798.
","[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Free University and Humboldt University Berlin, Charité-University Medicine Berlin, Charitéplatz 1, 10117, Berlin, Germany. gerd.burmester@charite.de.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Drescher', 'Affiliation': 'Veszprém Csolnoky Ferenc County Hospital, Veszprém, Hungary.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Hrycaj', 'Affiliation': 'Rheumatology, Koscian Municipal Hospital, Koscian, Poland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, TX, USA.'}]",Clinical rheumatology,['10.1007/s10067-020-05305-y']
1805,32873406,Comparison of immunogenicity between candidate influenza A(H3N2) virus vaccine strains in Japan: A randomized controlled trial using a monovalent vaccine of A/Saitama/103/2014 (CEXP-002) and A/Hong Kong/4801/2014 (X-263).,"BACKGROUND


For the 2017-18 influenza season, A/Saitama/103/2014 (CEXP-002) (Saitama strain) was antigenically more similar to prior circulating strains than A/Hong Kong/4801/2014 (X-263) (Hong Kong strain) in a ferret model and was selected as the A(H3N2) vaccine virus strain in Japan. However, the Saitama strain grew poorly, and the Japanese government switched to the Hong Kong strain, raising public concerns of poor effectiveness. To enhance understanding of the correlation between antigenicity in experimental models and immunogenicity, as a surrogate measure of vaccine effectiveness, in the human population, we compared the immunogenicity of specially-prepared single dose monovalent influenza A(H3N2) vaccines containing the Saitama or the Hong Kong strain.
METHODS


A randomized controlled trial of 100 healthy adults aged 20-64 years (n = 50/group) was conducted. Virus neutralization assay was performed on sera from days 0 (pre-vaccination) and 21 (post-vaccination). Geometric mean titer (GMT), mean fold rise (MFR), seroconversion proportion (SCP), and seroprotection proportion (SPP) were calculated for vaccine strains and a representative circulating A(H3N2) virus strain (A/Osaka/188/2017).
RESULTS


For the Hong Kong strain, post-vaccination GMT was significantly higher in the Hong Kong vaccine recipients (1:546 vs 1:260, p < 0.01), but MFR, SCP, and SPP were similar for both vaccine groups. For the Saitama strain, post-vaccination GMT (1:116 vs 1:61, p = 0.01) and SPP (86% vs 68%, p = 0.03) were significantly higher in the Hong Kong vaccine recipients, but MFR and SCP were similar for both vaccine groups. Against A/Osaka/188/2017, post-vaccination GMT and MFR were similar in both vaccine groups, but SCP (32% vs 4%, p < 0.01) and SPP (28% vs. 6%, p < 0.01) were significantly higher in the Hong Kong vaccine recipients.
CONCLUSION


The Hong Kong vaccine induced better or equivalent immunogenicity in comparison to the Saitama vaccine. Our trial showed that antigenic similarity in experimental models does not necessarily correlate with immunogenicity in the human population.
CLINICAL TRIAL REGISTRATION


UMIN000029293.",2020,"Against A/Osaka/188/2017, post-vaccination GMT and MFR were similar in both vaccine groups, but SCP (32% vs 4%, p < 0.01) and SPP (28% vs. 6%, p < 0.01) were significantly higher in the Hong Kong vaccine recipients.
","['Japan', 'vaccine virus strain in Japan', '100 healthy adults aged 20-64\xa0years (n\xa0=\xa050/group']","['candidate influenza A(H3N2', 'monovalent vaccine of A/Saitama/103/2014 (CEXP-002) and A/Hong Kong/4801/2014 (X-263']","['MFR and SCP', 'MFR, SCP, and SPP', 'SPP', 'Geometric mean titer (GMT), mean fold rise (MFR), seroconversion proportion (SCP), and seroprotection proportion (SPP']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4517671', 'cui_str': '263'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",100.0,0.0818063,"Against A/Osaka/188/2017, post-vaccination GMT and MFR were similar in both vaccine groups, but SCP (32% vs 4%, p < 0.01) and SPP (28% vs. 6%, p < 0.01) were significantly higher in the Hong Kong vaccine recipients.
","[{'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Kase', 'Affiliation': 'Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'SOUSEIKAI PS Clinic, Fukuoka, Japan.'}, {'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Morikawa', 'Affiliation': 'Department of Virology, Osaka Institute of Public Health, Osaka, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Kumashiro', 'Affiliation': 'SOUSEIKAI PS Clinic, Fukuoka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hiroi', 'Affiliation': 'Department of Virology, Osaka Institute of Public Health, Osaka, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Nakata', 'Affiliation': 'Department of Virology, Osaka Institute of Public Health, Osaka, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan; Healthcare Management, College of Healthcare Management, Miyama, Japan; Clinical Epidemiology Research Center, SOUSEIKAI, Fukuoka, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Ishibashi', 'Affiliation': 'SOUSEIKAI PS Clinic, Fukuoka, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Tsuru', 'Affiliation': 'SOUSEIKAI PS Clinic, Fukuoka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'SOUSEIKAI, Fukuoka, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maeda', 'Affiliation': 'Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Ohfuji', 'Affiliation': 'Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Wakaba', 'Initials': 'W', 'LastName': 'Fukushima', 'Affiliation': 'Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan. Electronic address: wakaba@med.osaka-cu.ac.jp.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Hirota', 'Affiliation': 'Clinical Epidemiology Research Center, SOUSEIKAI, Fukuoka, Japan; College of Healthcare Management, Miyama, Japan.'}]",Vaccine,['10.1016/j.vaccine.2020.08.025']
1806,32844606,The influence of Intrapulmonary percussive ventilation on gastroesophageal reflux in infants under the age of 1 year.,"BACKGROUND


Intrapulmonary percussive ventilation (IPV) is an airway clearance technique used at any age to facilitate the removal of secretions from the respiratory tract. The effect of IPV on gastroesophageal reflux(GER) is not well documented. This study aimed to determine the influence of IPV on GER in infants.
METHODS


During a 24-hour multichannel intraluminal impedance-pH monitoring (MII-pH), infants in the intervention group received a20 minutes session of IPV in upright position, 2 hours postprandial. The control group received no intervention and was placed in the same position for 20 minutes, 2 hours postprandial. The number of reflux episodes (REs) during IPV as compared to the number of REs in the control group during the 20 minutes period.
RESULTS


Fifty infants were included in each group;21 infants in the IPV group and 14 infants in the control group were diagnosed with abnormal MII-pH (P = .142). During IPV, the number of REs was significantly lower than in the control group (P < .001). Also in the subgroups with abnormal or normal MII-pH, a significantly lower number of REs during IPV was found (P = .011, P = .011 respectively).
CONCLUSION


IPV decreases the number of REs in infants independent of the results of MII-pH.",2020,"During IPV,thenumber of REswas significantly lower than in the control group (p< 0.001).","['infants under the age of one year', 'infants']","['Intrapulmonarypercussiveventilation (IPV', 'Intrapulmonary percussive ventilation', 'IPV']","['gastroesophageal reflux', 'number of REs during IPVwas', 'gastroesophageal reflux(GER', 'abnormal MII-pH', 'number of REs', 'number of reflux episodes (REs']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0442121', 'cui_str': 'Intrapulmonary'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}]",50.0,0.0341609,"During IPV,thenumber of REswas significantly lower than in the control group (p< 0.001).","[{'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Lievens', 'Affiliation': 'Rehabilitation Research, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Yvan', 'Initials': 'Y', 'LastName': 'Vandenplas', 'Affiliation': 'KidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Vanlaethem', 'Affiliation': 'Physiotherapy Department, UZ Brussel, Brussels, Belgium.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Van Ginderdeuren', 'Affiliation': 'Rehabilitation Research, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium.'}]",Pediatric pulmonology,['10.1002/ppul.25045']
1807,32853271,A clinical algorithm for same-day HIV treatment initiation in settings with high TB symptom prevalence in South Africa: The SLATE II individually randomized clinical trial.,"BACKGROUND


Many countries encourage same-day initiation of antiretroviral therapy (ART), but evidence on eligibility for same-day initiation, how best to implement it, and its impact on outcomes remains scarce. Building on the Simplified Algorithm for Treatment Eligibility (SLATE) I trial, in which nearly half of participants were ineligible for same-day initiation mainly because of TB symptoms, the study evaluated the revised SLATE II algorithm, which allowed same-day initiation for patients with mild TB symptoms and other less serious reasons for delay.
METHODS AND FINDINGS


SLATE II was a nonblinded, 1:1 individually randomized pragmatic trial at three primary healthcare clinics in Johannesburg, South Africa. It randomized adult patients presenting for an HIV test or any HIV care but not yet on ART. Intervention arm patients were assessed with a symptom screen, medical history, brief physical examination, and readiness questionnaire to distinguish between patients eligible for immediate ART dispensing and those requiring further care before initiation. Standard arm patients received usual care. Follow-up was by review of routine clinic records. Primary outcomes were (1) ART initiation in ≤7 days and (2) ART initiation in ≤28 days and retention in care at 8 months (composite outcome). From 14 March to 18 September 2018, 593 adult HIV+, nonpregnant patients were enrolled (median interquartile range [IQR] age 35 [29-43]; 63% (n = 373) female; median CD4 count 293 [133-487]). Half of study patients (n = 295) presented with TB symptoms, whereas only 13 (4%) standard arm and 7 (2%) intervention arm patients tested positive for TB disease. Among 140 intervention arm patients with TB symptoms, 72% were eligible for same-day initiation. Initiation was higher in the intervention (n = 296) versus standard arm (n = 297) by 7 days (91% versus 68%; risk difference [RD] 23% [95% confidence interval (CI) 17%-29%]) and 28 days (94% versus 82%; RD 12% [7%-17%]) after enrollment. In total, 87% of intervention and 38% of standard arm patients initiated on the same day. By 8 months after study enrollment, 74% (220/296) of intervention and 59% (175/297) of standard arm patients had both initiated ART in ≤28 days and been retained in care (RD 15% [7%-23%]). Among the 41% of participants with viral load results available, suppression was 90% in the standard arm and 92% in the intervention arm among patients initiated in ≤28 days. No ART-associated adverse events were reported after initiation; two intervention and four standard arm patients were reported to have died during passive follow-up. Limitations of the study included limited geographic generalizability, exclusion of patients too sick to consent, fluctuations in procedures in the standard arm over the course of the study, high fidelity to the trial protocol by study staff, and the possibility of overestimating loss to follow-up due to data constraints.
CONCLUSIONS


More than 85% of patients presenting for HIV testing or care, including those newly diagnosed, were eligible and ready for same-day initiation under the SLATE II algorithm. The algorithm increased initiation within 7 days without appearing to compromise retention and viral suppression at 8 months, offering a practical and acceptable approach that can be widely and immediately utilized by existing providers.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03315013, registered 19 October 2017. First participant enrolled 14 March 2018.",2020,No ART-associated adverse events were reported after initiation; two intervention and four standard arm patients were reported to have died during passive follow-up.,"['140 intervention arm patients with TB symptoms, 72% were eligible for same-day initiation', 'adult patients presenting for an HIV test or any HIV care but not yet on ART', 'From 14 March to 18 September 2018, 593 adult HIV+, nonpregnant patients were enrolled (median interquartile range [IQR] age 35 [29-43]; 63% (n = 373) female; median CD4 count 293 [133-487', 'Intervention arm patients were assessed with a symptom screen, medical history, brief physical examination, and readiness questionnaire to distinguish between patients eligible for immediate ART dispensing and those requiring further care before initiation', 'settings with high TB symptom prevalence in South Africa', 'SLATE II was a nonblinded, 1:1 individually randomized pragmatic trial at three primary healthcare clinics in Johannesburg, South Africa']",['usual care'],"['ART initiation in ≤7 days and (2) ART initiation in ≤28 days and retention in care', 'adverse events', 'Initiation', 'TB symptoms']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C3658215', 'cui_str': 'Practical Clinical Trials'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",[],"[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",3.0,0.352693,No ART-associated adverse events were reported after initiation; two intervention and four standard arm patients were reported to have died during passive follow-up.,"[{'ForeName': 'Mhairi', 'Initials': 'M', 'LastName': 'Maskew', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Alana T', 'Initials': 'AT', 'LastName': 'Brennan', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lungisile', 'Initials': 'L', 'LastName': 'Vezi', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Willem D F', 'Initials': 'WDF', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, Washington, United States of America.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",PLoS medicine,['10.1371/journal.pmed.1003226']
1808,32853900,Effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment: A randomized controlled trial among Iranian pregnant women.,"BACKGROUND AND PURPOSE


Although mindfulness-based childbirth and parenting is suggested to promote maternal-fetal attachment, no study has yet addressed its potential effects. This study aimed to determine the effects of a mindfulness-based childbirth and parenting program on maternal-fetal attachment among Iranian pregnant women.
MATERIALS AND METHODS


This study was conducted on pregnant women, who were divided into two groups to either receive routine care plus mindfulness training for childbirth and parenting (i.e., eight 2-h group sessions once a week and one 3-h session of silent meditation) or receive routine care alone. Maternal-fetal attachment was evaluated by the Cranley's Maternal-Fetal Attachment Scale.
RESULTS


After the intervention, the total score of maternal-fetal attachment was significantly higher in the experimental group (P < 0.001; effect size = 0.640). In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
CONCLUSION


The implemented program in this study was potentially effective in promoting maternal-fetal attachment.",2020,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","['pregnant women', 'Iranian pregnant women']","['routine care plus mindfulness training', 'routine care alone', 'mindfulness-based childbirth and parenting program']","['dimension of ""attributing characteristics to the fetus"" improved', 'total score of maternal-fetal attachment', 'dimension of ""differentiation of self from the fetus', 'Maternal-fetal attachment', 'maternal-fetal attachment', ""Cranley's Maternal-Fetal Attachment Scale""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0224299,"In the intervention group, all dimensions of maternal-fetal attachment significantly improved, except the dimension of ""differentiation of self from the fetus"", whereas in the control group, only the dimension of ""attributing characteristics to the fetus"" improved.
","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Gheibi', 'Affiliation': 'Student Research Committee, Department of Midwifery, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Zeinab_gheibi@yahoo.com.'}, {'ForeName': 'Zabihollah', 'Initials': 'Z', 'LastName': 'Abbaspour', 'Affiliation': 'Department of Psychology, School of Education and Psychology, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: Zabbaspour1356@gmail.com.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighyzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Haghighy-mh@ajums.ac.ir.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Javadifar', 'Affiliation': 'Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Javadifar-n@ajums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101226']
1809,32853919,Validation of sleep stage classification using non-contact radar technology and machine learning (Somnofy®).,"OBJECTIVE


To validate automatic sleep stage classification using deep neural networks on sleep assessed by radar technology in the commercially available sleep assistant Somnofy® against polysomnography (PSG).
METHODS


Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions. The Somnofy unit was placed in two different locations per room (nightstand and wall). The sleep algorithm was validated against PSG using a 25-fold cross validation technique, and performance was compared to the inter-rater reliability between the PSG sleep scored by two independent sleep specialists.
RESULTS


Epoch-by-epoch analyses showed a sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake) for Somnofy of 0.97 and 0.72 respectively, compared to 0.99 and 0.85 for the PSG scorers. The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96. The intraclass correlation coefficient revealed excellent and good reliability for total sleep time and sleep efficiency, while sleep onset and R latency had poor agreement. Somnofy underestimated total wake time by 5 min and N1/N2 by 3 min. N3 was overestimated by 4 min and R by 3 min. Results were independent of institution and sensor location.
CONCLUSION


Somnofy showed a high accuracy staging sleep in healthy individuals and has potential to assess sleep quality and quantity in a sample of healthy, mostly young adults. More research is needed to examine performance in children, older individuals and those with sleep disorders.",2020,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","['children, older individuals and those with sleep disorders', 'Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions', 'healthy individuals']",['non-contact radar technology and machine learning (Somnofy®'],"['sleep stage differentiation', 'total wake time', 'accuracy staging sleep', 'total sleep time and sleep efficiency', 'sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.0201471,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","[{'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Toften', 'Affiliation': 'Department of Data Science, VitalThings AS, Tønsberg, Norway. Electronic address: st@vitalthings.com.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway; Norwegian Competence Center for Sleep Disorders, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hrozanova', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Moen', 'Affiliation': 'Department of Education and Lifelong Learning, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.022']
1810,32854000,Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial.,"BACKGROUND


HIV-infected people who use drugs (PWUD) have poor HIV outcomes. Few studies tested interventions to improve HIV outcomes among PWUD. Abstinence-reinforcing contingency management (CM) reduces drug use and could also improve HIV outcomes.
METHODS


From 2012-2017, we conducted a randomized controlled trial testing whether a 16-week abstinence-reinforcing CM intervention improved HIV viral load (VL) among HIV-infected adults using opioids or cocaine. In the CM intervention, drug-free urines led to escalating value of vouchers ($2.50-$80/voucher, $1320 total maximum). In intention-to-treat mixed-effects linear and logistic regression analyses, we examined whether the CM intervention improved log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes).
RESULTS


Thirty-seven participants were randomized to the CM intervention and 36 to control. Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6%). In CM (vs. control) participants, mean reduction in log 10  VL was greater (-0.16 log 10  VL copies/mL per 4-week period; 95% CI: -0.29 to -0.03, p < 0.05). Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants. The CM intervention was not significantly associated with abstinence or adherence.
CONCLUSIONS


This is the first study to demonstrate improvements in HIV VL via an abstinence-reinforcing CM intervention. Because the CM intervention did not significantly affect abstinence or adherence, the mechanism of its effect is unclear. To end the HIV epidemic, innovative strategies must address individuals with poor HIV outcomes. Abstinence-reinforcing CM may be one potential strategy to improve HIV outcomes among a select group of PWUD.",2020,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","['From 2012-2017', 'HIV-infected people who use drugs', 'Thirty-seven participants', 'HIV-infected adults using', 'Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6']","['opioids or cocaine', 'Abstinence-reinforcing contingency management (CM', 'CM intervention', 'abstinence-reinforcing CM intervention', 'Abstinence-reinforcing contingency management']","['mean reduction in log 10  VL', 'log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes', 'HIV viral load suppression', 'HIV outcomes', 'HIV viral load (VL', 'abstinence or adherence']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",37.0,0.178726,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","[{'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States. Electronic address: ccunning@montefiore.org.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Clemson University College of Behavioral, Social and Health Sciences, Department of Public Health Sciences, Clemson Nursing Building, 605 Grove Road, Greenville, SC 29605, United States.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Bachhuber', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Lousiana State University Health Sciences Center-New Orleans, Section of Community and Population Medicine, Department of Medicine, 533 Bolivar St, New Orleans, LA 70112, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Jost', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grossberg', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Stein', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Sohler', 'Affiliation': 'City University of New York, School of Medicine, 160 Convent Ave, New York, NY 10031, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108230']
1811,32857060,An Image-Based Mobile Health App for Postdrainage Monitoring: Usability Study.,"BACKGROUND


The application of mobile health (mHealth) platforms to monitor recovery in the postdischarge period has increased in recent years. Despite widespread enthusiasm for mHealth, few studies have evaluated the usability and user experience of mHealth in patients with surgical drainage.
OBJECTIVE


Our objectives were to (1) develop an image-based smartphone app, SurgCare, for postdrainage monitoring and (2) determine the feasibility and clinical value of the use of SurgCare by patients with drainage.
METHODS


We enrolled 80 patients with biliary or peritoneal drainage in this study. A total of 50 patients were assigned to the SurgCare group, who recorded drainage monitoring data with the smartphone app; and 30 patients who manually recorded the data were assigned to the conventional group. The patients continued to record data until drain removal. The primary aim was to validate feasibility for the user, which was defined as the proportion of patients using each element of the system. Moreover, the secondary aim was to evaluate the association of compliance with SurgCare and the occurrence of unexpected events.
RESULTS


The average submission duration was 14.98 days, and the overall daily submission rate was 84.2%. The average system usability scale was 83.7 (SD 3.5). This system met the definition of ""definitely feasible"" in 34 patients, ""possibly feasible"" in 10 patients, and ""not feasible"" in 3 patients. We found that the occurrence rates of complications in the SurgCare group and the conventional group were 6% and 26%, respectively, with statistically significant differences P=.03. The rate of unexpected hospital return was lower in the SurgCare group (6%) than in the conventional groups (26%) (P=.03).
CONCLUSIONS


Patients can learn to use a smartphone app for postdischarge drainage monitoring with high levels of user satisfaction. We also identified a high degree of compliance with app-based drainage-recording design features, which is an aspect of mHealth that can improve surgical care.",2020,"The rate of unexpected hospital return was lower in the SurgCare group (6%) than in the conventional groups (26%) (P=.03).
","['patients with surgical drainage', 'patients with drainage', '50 patients were assigned to the SurgCare group, who recorded drainage monitoring data with the smartphone app; and 30 patients who manually recorded the data were assigned to the conventional group', '80 patients with biliary or peritoneal drainage in this study']",[],"['average submission duration', 'rate of unexpected hospital return', 'occurrence rates of complications', 'average system usability scale', 'overall daily submission rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",80.0,0.040476,"The rate of unexpected hospital return was lower in the SurgCare group (6%) than in the conventional groups (26%) (P=.03).
","[{'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Liao', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Yu-Tung', 'Initials': 'YT', 'LastName': 'Wu', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chi-Tung', 'Initials': 'CT', 'LastName': 'Cheng', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chun-Hsiang', 'Initials': 'CH', 'LastName': 'Ooyang', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Shih-Ching', 'Initials': 'SC', 'LastName': 'Kang', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chih-Yuan', 'Initials': 'CY', 'LastName': 'Fu', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Yu-Pao', 'Initials': 'YP', 'LastName': 'Hsu', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chi-Hsun', 'Initials': 'CH', 'LastName': 'Hsieh', 'Affiliation': 'Department of Trauma and Emergency Surgery, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}, {'ForeName': 'Chih-Chi', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Linkou Chang Gung Memorial Hospital, Chang Gang University, Taoyaun, Taiwan.'}]",Journal of medical Internet research,['10.2196/17686']
1812,32858346,"Effects of treatment of sleep disorders on sleep, psychological and cognitive functioning and biomarkers in individuals with HIV/AIDS and under methadone maintenance therapy.","BACKGROUND


Poor sleep is a major complaint of people with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and undergoing methadone maintenance therapy (MMT). We tested the impact of three different sleep-improving interventions (trazodone; sleep hygiene training; sleep hygiene training + trazodone) on sleep, psychological functioning and biomarkers in males with HIV and undergoing MMT.
METHODS


A total of 75 male outpatients (mean age: 39.6 years) participated in a 12 week intervention. Participants were randomly assigned to one of the following conditions: trazodone 50 mg/d (TRAZ); sleep hygiene training (SHT); sleep hygiene training and trazodone (SHT + TRAZ). At baseline, and six and 12 weeks later, participants completed questionnaires covering subjective sleep and daytime sleepiness, and symptoms of depression and anxiety. In parallel, their cognitive performance (working memory; sustained attention) was assessed. Biomarkers (cortisol, BNDF, CD4 + ) were assessed at baseline and at the end of the study.
RESULTS


Over time, sleep disturbances decreased and daytime functioning and overall sleep quality improved. More specifically, both sleep disturbances and daytime functioning improved in the two SHT conditions from baseline to week 6. Daytime functioning remained stable from week 6 to week 12. Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12. Daytime sleepiness, symptoms of insomnia and sleep-disordered breathing remained unchanged. Sustained attention performance improved over time from baseline to week 6 and remained high through to week 12. Biomarkers remained unchanged.
CONCLUSIONS


In males with HIV and undergoing MMT, treating sleep disturbances over a period of six to 12 weeks had a positive impact on aspects of sleep disturbance, symptoms of depression and anxiety, and cognitive performance. The results indicate that sleep hygiene training, either as stand-alone or in combination with trazodone, can produce positive results.",2020,"Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12.","['75 male outpatients (mean age: 39.6 years) participated in a 12 week intervention', 'males with HIV and undergoing', 'males with HIV and undergoing MMT', 'people with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and undergoing', 'individuals with HIV/AIDS and under methadone maintenance therapy']","['MMT', 'methadone maintenance therapy (MMT', 'sleep-improving interventions (trazodone; sleep hygiene training; sleep hygiene training\xa0+\xa0trazodone', 'trazodone 50\xa0mg/d (TRAZ); sleep hygiene training (SHT); sleep hygiene training and trazodone (SHT\xa0+\xa0TRAZ', 'trazodone']","['sleep, psychological and cognitive functioning and biomarkers', 'sleep, psychological functioning and biomarkers', 'Daytime sleepiness, symptoms of insomnia and sleep-disordered breathing', 'questionnaires covering subjective sleep and daytime sleepiness, and symptoms of depression and anxiety', 'depression and anxiety', 'Sustained attention performance', 'sleep disturbances and daytime functioning', 'Daytime functioning', 'sleep disturbances', 'Biomarkers (cortisol, BNDF, CD4 + ', 'daytime functioning and overall sleep quality', 'sleep disturbance, symptoms of depression and anxiety, and cognitive performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001175', 'cui_str': 'AIDS'}]","[{'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",75.0,0.0231424,"Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Alikhani', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ebrahimi', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Farnia', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Radmehr', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Mohamadi', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Omran', 'Initials': 'O', 'LastName': 'Davarinejad', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Dürsteler', 'Affiliation': 'University of Basel, Psychiatric Clinics, Division of Substance Use Disorders Basel, Switzerland.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran. Electronic address: serge.brand@upk.ch.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.043']
1813,32858371,Effect of video-assisted information prior to intratympanic steroid injection on patient anxiety.,"OBJECTIVE


Patients may be afraid when they receive knowledge that medications are injected into the middle ear through the tympanic membrane using a fine needle during intratympanic treatment. The aim of this study was to evaluate the effect of video-assisted information prior to intratympanic steroid injection on patient anxiety.
STUDY DESIGN


Prospective, Non-randomized, controlled trial.
SETTING


Tertiary academic medical center.
METHODS


A total of 85 patients who had an indication for intratympanic treatment due to idiopathic sudden sensorineural hearing loss and tinnitus were included in this prospective study. 40 cases received video-assisted information before intratympanic steroid injection in the study group, while 45 cases were verbally informed face-to-face in the control group. Then, patient anxiety was measured using the Visual Analog Scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI).
RESULTS


The mean VAS score was 3.58 ± 3.37 (mean rank = 42.09) in the study group and 3.87 ± 3.56 (mean rank = 43.81) in the control group. The mean STAI-S score was 37.03 ± 10.637 in the study group and 39.11 ± 11.783 in the control group. The mean STAI-T score was 40.18 ± 9.151 in the study group and 38.73 ± 11.438 in the control group. It was found that there were no statistically significant differences in the mean VAS, STAI-S and STAI-T scores between the two groups (p > 0.05).
CONCLUSION


We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.",2020,We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.,"['40 cases received', 'Tertiary academic medical center', '85 patients who had an indication for intratympanic treatment due to idiopathic sudden sensorineural hearing loss and tinnitus', 'patient anxiety']","['video-assisted information prior to intratympanic steroid injection', 'video-assisted information before intratympanic steroid injection']","['mean VAS, STAI-S and STAI-T scores', 'mean STAI-T score', 'mean STAI-S score', 'mean VAS score', 'Visual Analog Scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI', 'patient anxiety']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",85.0,0.0321367,We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.,"[{'ForeName': 'Nurdoğan', 'Initials': 'N', 'LastName': 'Ata', 'Affiliation': 'Department of Otorhinolaryngology, KTO Karatay University Medical Faculty, Medicana Hospital, Konya, Turkey. Electronic address: op.dr.na@gmail.com.'}, {'ForeName': 'Necat', 'Initials': 'N', 'LastName': 'Alataş', 'Affiliation': 'Department of Otolaryngology, Uşak University Medical Faculty, Uşak, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Güllüev', 'Affiliation': 'Department of Otorhinolaryngology, Medical Sciences University Konya Training and Research Hospital, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': ""Department of Otolaryngology, Dr. Ali Kemal Belviranlı Maternity and Children's Hospital, Konya, Turkey.""}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102689']
1814,32858393,Reducing fall risk for home care workers with slip resistant winter footwear.,"Falls on icy surfaces are the leading cause of occupational injuries for workers exposed to outdoor winter conditions. Slip resistant footwear has been shown to reduce the risk of falls for indoor workers but until recently, there was no accepted standard for evaluating the slip resistance of winter footwear on icy surfaces. Our team recently developed a lab-based testing protocol for measuring footwear slip resistance. This protocol, called the Maximum Achievable Angle (MAA) test, measures the steepest ice-covered slope that participants can walk up and down without experiencing a slip in a simulated winter environment. This lab-based protocol has found there is wide variability in the performance of commercially available winter footwear. In particular, we have found that a new generation of footwear that incorporates composite materials in the outsole, performs much better than most other footwear. The objective of this project was to investigate whether the footwear that performed well in our lab-based testing would reduce the risk of slips and/or falls in real-world winter conditions. One hundred and ten home healthcare workers from SE Health were recruited for this study and were asked to report their exposure to icy surfaces along with the numbers of slips and numbers of falls they experienced each week using online surveys over eight weeks in the winter. Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test. The remaining sixty participants (the control group) wore their own footwear for the duration of the study. A total of 563 slips and 36 falls were reported over the eight-week data collection period. The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group. We found the slip rate in the intervention group was between 68.0% and 68.7% lower than the control group. Similarly, the fall rate was between 78.5% and 81.5% lower in the intervention group compared to the control group. These findings demonstrate that footwear that performs well in the MAA test can reduce the risk of both slips and falls in real-world winter conditions.",2020,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"['Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test', 'One hundred and ten home healthcare workers from SE Health', 'home care workers with slip resistant winter footwear']",[],"['fall rate', 'slip rate']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}]",563.0,0.0200659,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"[{'ForeName': 'Z Shaghayegh', 'Initials': 'ZS', 'LastName': 'Bagheri', 'Affiliation': 'Department of Mechanical Engineering, George Mason University, 4400 University Dr, Fairfax, VA, 22030, USA; Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada. Electronic address: sbagheri@gmu.edu.'}, {'ForeName': 'Jose Diaz', 'Initials': 'JD', 'LastName': 'Beltran', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Holyoke', 'Affiliation': 'Saint Elizabeth Health Care, 90 Allstate Parkway, Suite 300, Markham, Ontario, L3R 5H3, Canada.'}, {'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada; Institute of Biomedical Engineering, University of Toronto, 164 College St., Toronto, M5S3G9, Canada.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103230']
1815,32858399,Effect of antenatal magnesium sulphate on MRI biomarkers of white matter development at term equivalent age: The magnum study.,"BACKGROUND


Magnesium sulphate given to women immediately prior to very preterm birth protects the perinatal brain, so fewer babies die or develop cerebral palsy. How magnesium sulphate exerts these beneficial effects remains uncertain. The aim of the MagNUM Study was to assess the effect of exposure to antenatal magnesium sulphate on MRI measures of brain white matter microstructure at term equivalent age.
METHODS


Nested cohort study within the randomised Magnesium sulphate at 30 to <34 weeks' Gestational age Neuroprotection Trial (MAGENTA). Mothers at risk of preterm birth at 30 to <34 weeks' gestation were randomised to receive either 4 g of magnesium sulphate heptahydrate [8 mmol magnesium ions], or saline placebo, infused over 30 min when preterm birth was planned or expected within 24 h. Participating babies underwent diffusion tensor MRI at term equivalent age. The main outcomes were fractional anisotropy across the white matter tract skeleton compared using Tract-based Spatial Statistics (TBSS), with adjustment for postmenstrual age at birth and at MRI, and MRI site. Researchers and families were blind to treatment group allocation during data collection and analyses.
FINDINGS


Of the 109 participating babies the demographics of the 60 babies exposed to magnesium sulphate were similar to the 49 babies exposed to placebo. In babies whose mothers were allocated to magnesium sulphate, fractional anisotropy was higher within the corticospinal tracts and corona radiata, the superior and inferior longitudinal fasciculi, and the inferior fronto-occipital fasciculi compared to babies whose mothers were allocated placebo (P < 0.05).
INTERPRETATION


In babies born preterm, antenatal magnesium sulphate exposure promotes development of white matter microstructure in pathways affecting both motor and cognitive function. This may be one mechanism for the neuroprotective effect of magnesium sulphate treatment prior to preterm birth.
FUNDING


Health Research Council of New Zealand.",2020,"In babies born preterm, antenatal magnesium sulphate exposure promotes development of white matter microstructure in pathways affecting both motor and cognitive function.","['109 participating babies', ""Mothers at risk of preterm birth at 30 to <34 weeks' gestation"", ""at 30 to <34 weeks' Gestational age Neuroprotection Trial"", 'babies born preterm', 'white matter development at term equivalent age', 'brain white matter microstructure at term equivalent age']","['magnesium sulphate heptahydrate [8\xa0mmol magnesium ions], or saline placebo', 'magnesium sulphate', 'placebo', 'Magnesium sulphate', 'antenatal magnesium sulphate']","['fractional anisotropy across the white matter tract skeleton compared using Tract-based Spatial Statistics (TBSS), with adjustment for postmenstrual age at birth and at MRI, and MRI site', 'MRI biomarkers']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0598958', 'cui_str': 'Neuron Protection'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]","[{'cui': 'C0772046', 'cui_str': 'Magnesium sulfate heptahydrate'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C2346927', 'cui_str': 'Magnesium Cation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}]","[{'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.260441,"In babies born preterm, antenatal magnesium sulphate exposure promotes development of white matter microstructure in pathways affecting both motor and cognitive function.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Poppe', 'Affiliation': ""Department of Optometry and Vision Science, University of Auckland, Auckland, New Zealand; Centre for the Developing Brain, Department of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'Department of Optometry and Vision Science, University of Auckland, Auckland, New Zealand; School of Optometry and Vision Science, University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Boardman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom; MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Bastin', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Alsweiler', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Deib', 'Affiliation': 'Department of Radiology, West Virginia University Hospital, W.Va, United States.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, University of Auckland, Building 503, Level 2, 85 Park Road, Auckland 1142, New Zealand.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, University of Auckland, Building 503, Level 2, 85 Park Road, Auckland 1142, New Zealand. Electronic address: c.crowther@auckland.ac.nz.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EBioMedicine,['10.1016/j.ebiom.2020.102957']
1816,32865145,Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty.,"PURPOSE


To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease.
MATERIALS AND METHODS


The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial ( ClinicalTrials.gov  identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months.
RESULTS


Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group.
CONCLUSION


The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease.",2020,"All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group.
","['Japanese participants with femoropopliteal occlusive disease', 'Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32', 'Japanese population with femoropopliteal occlusive disease']","['Percutaneous Transluminal Angioplasty', 'IN.PACT Admiral DCB', 'MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA']","['CD-TLR rates', 'All-cause death', 'freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound', 'Kaplan-Meier estimate', 'safety composite endpoint', '3-year safety and effectiveness']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0242845', 'cui_str': 'Duplex ultrasound'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.1316,"All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group.
","[{'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Soga', 'Affiliation': 'Kokura Memorial Hospital, Fukuoka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Iida', 'Affiliation': 'Kansai Rosai Hospital, Hyogo, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Urasawa', 'Affiliation': 'ToKeidai Memorial Hospital, Hokkaido, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Shonan Kamakura General Hospital, Kanagawa, Japan.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Medtronic, Santa Rosa, CA, USA.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Ookubo', 'Affiliation': 'Medtronic, Minato-ku, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yokoi', 'Affiliation': 'Fukuoka Sanno Hospital, Fukuoka, Japan.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820948240']
1817,32862247,Blunted cardiac output response to exercise in adolescents born preterm.,"PURPOSE


Premature birth is associated with lasting effects, including lower exercise capacity and pulmonary function, and is acknowledged as a risk factor for cardiovascular disease. The aim was to evaluate factors affecting exercise capacity in adolescents born preterm, including the cardiovascular and pulmonary responses to exercise, activity level and strength.
METHODS


21 preterm-born and 20 term-born adolescents (age 12-14 years) underwent strength and maximal exercise testing with thoracic bioimpedance monitoring. Baseline variables were compared between groups and ANCOVA was used to compare heart rate, cardiac output (Q) and stroke volume (SV) during exercise between groups while adjusting for body surface area.
RESULTS


Preterm-borns had lower maximal aerobic capacity than term-borns (2.0 ± 0.5 vs. 2.5 ± 0.5 L/min, p = 0.01) and lower maximal power (124 ± 26 vs. 153 ± 33 watts, p < 0.01), despite similar physical activity scores. Pulmonary function and muscular strength did not differ significantly. Although baseline Q and SV did not differ between groups, preterm adolescents had significantly lower cardiac index (Qi) at 50, 75 and 100% of maximal time to exhaustion, driven by SV volume index (SVi, 50% max time: 53.0 ± 9.0 vs. 61.6 ± 11.4; 75%: 51.7 ± 8.4 vs. 64.3 ± 11.1; 100%: 51.2 ± 9.3 vs. 64.3 ± 11.5 ml/m 2 , all p < 0.01), with similar heart rates.
CONCLUSION


Otherwise healthy and physically active adolescents born very preterm exhibit lower exercise capacity than term-born adolescents. Despite similar baseline cardiovascular values, preterm-born adolescents demonstrate significantly reduced Qi and SVi during incremental and maximal exercise.",2020,Pulmonary function and muscular strength did not differ significantly.,"['21 preterm-born and 20 term-born adolescents (age 12-14\xa0years) underwent', 'Otherwise healthy and physically active adolescents born very preterm exhibit lower exercise capacity than term-born adolescents', 'adolescents born preterm']",['strength and maximal exercise testing with thoracic bioimpedance monitoring'],"['cardiovascular and pulmonary responses to exercise, activity level and strength', 'Qi and SVi', 'Pulmonary function and muscular strength', 'heart rate, cardiac output (Q) and stroke volume (SV', 'cardiac index (Qi', 'physical activity scores', 'maximal aerobic capacity']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",,0.0753262,Pulmonary function and muscular strength did not differ significantly.,"[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Haraldsdottir', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA. haraldsdottir@ortho.wisc.edu.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Watson', 'Affiliation': 'Department of Orthopedics & Rehabilitation, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Pegelow', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Palta', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Tetri', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Levin', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Brix', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Centanni', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Kara N', 'Initials': 'KN', 'LastName': 'Goss', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}, {'ForeName': 'Marlowe M', 'Initials': 'MM', 'LastName': 'Eldridge', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison, Madison, USA.'}]",European journal of applied physiology,['10.1007/s00421-020-04480-9']
1818,32868028,Effect of Whole-Body Vibration Exercise on Power Profile and Bone Mineral Density in Postmenopausal Women With Osteoporosis: A Randomized Controlled Trial.,"OBJECTIVE


The purpose of this study was to investigate the effect of whole-body vibration (WBV) on muscle work and bone mineral density (BMD) of the lumbar vertebrae and femur in postmenopausal women.
METHODS


Forty-three postmenopausal women with low BMD were randomly assigned to WBV and control groups. Both groups received calcium and vitamin D supplementations once daily, while the WBV group additionally received WBV exercise (twice/wk) for 24 successive weeks. Qualisys gait analysis system was used to measure hip power generation by hip extensors (H1S) and flexors (H3S), hip power absorption by hip flexors (H2S), knee power absorption by quadriceps during loading response (K1S) and preswing (K3S), knee power absorption by hamstring (K4S), knee power generation by quadriceps (K2S), ankle power absorption by dorsiflexors (A1S) and plantar flexors (A2S), and ankle power generation by plantar flexors (A3S). Also, dual-energy X-ray absorptiometry was used to measure BMD of the lumbar vertebrae and femur before and after the intervention.
RESULTS


There were significant increases (P < .05) in the hip muscle work (H1S, H2S, and H3S), knee muscle work (K1S, K2S, K3S, and K4S), ankle muscle work (A1S, A2S, and A3S) during gait, and BMD of the lumbar vertebrae and femur of the WBV group. However, there were no significant changes (P > .05) in the control group. The posttreatment values of the hip, knee, and ankle muscle work and BMD of the WBV group were significantly (P < .05) higher than the posttreatment values of the control group.
CONCLUSION


Whole-body vibration training improved the leg muscle work and lumbar and femoral BMD in postmenopausal women with low BMD.",2020,"There were significant increases (P < .05) in the hip muscle work (H1S, H2S, and H3S), knee muscle work (K1S, K2S, K3S, and K4S), ankle muscle work (A1S, A2S, and A3S) during gait, and BMD of the lumbar vertebrae and femur of the WBV group.","['postmenopausal women with low BMD', 'Forty-three postmenopausal women with low BMD', 'Postmenopausal Women With Osteoporosis', 'postmenopausal women']","['Whole-Body Vibration Exercise', 'Whole-body vibration training', 'calcium and vitamin D supplementations', 'whole-body vibration (WBV', 'WBV exercise']","['hip muscle work (H1S, H2S, and H3S), knee muscle work (K1S, K2S, K3S, and K4S), ankle muscle work (A1S, A2S, and A3S) during gait, and BMD of the lumbar vertebrae and femur', 'leg muscle work and lumbar and femoral BMD', 'posttreatment values of the hip, knee, and ankle muscle work and BMD', 'muscle work and bone mineral density (BMD', 'Power Profile and Bone Mineral Density', 'hip power generation by hip extensors (H1S) and flexors (H3S), hip power absorption by hip flexors (H2S), knee power absorption by quadriceps during loading response (K1S) and preswing (K3S), knee power absorption by hamstring (K4S), knee power generation by quadriceps (K2S), ankle power absorption by dorsiflexors (A1S) and plantar flexors (A2S), and ankle power generation by plantar flexors (A3S']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0224415', 'cui_str': 'Skeletal muscle structure of hip'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C2001403', 'cui_str': 'H2S(D2S)'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]",43.0,0.0192285,"There were significant increases (P < .05) in the hip muscle work (H1S, H2S, and H3S), knee muscle work (K1S, K2S, K3S, and K4S), ankle muscle work (A1S, A2S, and A3S) during gait, and BMD of the lumbar vertebrae and femur of the WBV group.","[{'ForeName': 'Abeer M', 'Initials': 'AM', 'LastName': 'ElDeeb', 'Affiliation': ""Department of Physical Therapy for Women's Health, Cairo University, Giza, Egypt.""}, {'ForeName': 'Amr A', 'Initials': 'AA', 'LastName': 'Abdel-Aziem', 'Affiliation': 'Department of Biomechanics, Cairo University, Giza, Egypt. Electronic address: Amralmaz@yahoo.com.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.12.003']
1819,32866927,The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale.,"Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The ""IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact"" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.",2020,"The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.","['approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design', 'Patients undergoing PCI involving a complex lesion are eligible for enrollment']","['IVUS guidance', 'intraVascular ultrasound-guided treatment', 'Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI', 'IVUS-guided versus angiography-guided PCI']","['rate of target vessel failure at 12\u202fmonths, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",3100.0,0.119591,"The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.","[{'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Shlofmitz', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Torguson', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sharp', 'Affiliation': 'University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'John McB', 'Initials': 'JM', 'LastName': 'Hodgson', 'Affiliation': 'Case Western Reserve School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Binita', 'Initials': 'B', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine (Cardiology), VA New York Harbor Healthcare System and New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Kumar', 'Affiliation': 'Emory University / Atlanta VA Medical Center, Atlanta, GA, USA.'}, {'ForeName': 'Jasvindar', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Washington University School of Medicine/ Barnes Jewish Hospital, St Louis, MO, USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Inderbitzen', 'Affiliation': 'Philips, Amsterdam, Netherlands.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Weintraub', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Mario', 'Affiliation': 'Structural Interventional Cardiology, University Hospital Careggi, Florence, Italy.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address: Ron.Waksman@MedStar.net.'}]",American heart journal,['10.1016/j.ahj.2020.08.002']
1820,32866928,"RHAPSODY: Rationale for and design of a pivotal Phase 3 trial to assess efficacy and safety of rilonacept, an interleukin-1α and interleukin-1β trap, in patients with recurrent pericarditis.","Recurrent pericarditis (RP) occurs in 15% to 30% of patients following a first episode, despite standard treatment with nonsteroidal anti-inflammatory drugs, colchicine, and corticosteroids; many patients become dependent on corticosteroids. Rilonacept (KPL-914), an interleukin-1α and β inhibitor, is in development for the treatment of RP. RHAPSODY, a double-blind, placebo-controlled, randomized-withdrawal (RW) pivotal Phase 3 trial (NCT03737110), enrolls patients 12 years or older presenting with at least a third pericarditis episode, pericarditis pain score ≥4 (11-point numeric rating scale [NRS]), and C-reactive protein ≥1 mg/dL at screening. After a subcutaneous loading dose (adults, 320 mg; children, 4.4 mg/kg), all patients receive blinded weekly subcutaneous rilonacept (adults, 160 mg; children, 2.2 mg/kg) during the run-in period. Patients must taper and discontinue concomitant pericarditis medications during the blinded run-in period and achieve clinical response (C-reactive protein ≤0.5 mg/dL and weekly average NRS ≤2.0 during the 7 days prior to and including the day of randomization) by end of the run-in (while on rilonacept monotherapy) to be randomized to either continued rilonacept or placebo in the RW period. Primary efficacy end point was time to adjudicated pericarditis recurrence during the RW period; secondary efficacy end points were proportion of patients maintaining clinical response, percentage of days with NRS ≤2, and percentage of patients with no-to-minimal pericarditis symptoms at week 16 of the RW period. Safety evaluations include adverse event monitoring, physical examinations, and laboratory tests. The RHAPSODY trial will evaluate the efficacy and safety of rilonacept in the treatment of RP to improve outcomes and patient health-related quality of life.",2020,"Rilonacept (KPL-914), an interleukin-1α and β inhibitor, is in development for the treatment of RP.","['enrolls patients 12 years or older presenting with at least a third pericarditis episode, pericarditis pain score ≥4 (11-point numeric rating scale [NRS]), and C-reactive protein ≥1 mg/dL at screening', 'patients with recurrent pericarditis']","['rilonacept or placebo', 'Rilonacept (KPL-914', 'blinded weekly subcutaneous rilonacept', 'placebo', 'rilonacept', 'colchicine, and corticosteroids']","['adverse event monitoring, physical examinations, and laboratory tests', 'time to adjudicated pericarditis recurrence', 'Recurrent pericarditis (RP', 'proportion of patients maintaining clinical response, percentage of days with NRS ≤2, and percentage of patients with no-to-minimal pericarditis symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C2343589', 'cui_str': 'rilonacept'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.110477,"Rilonacept (KPL-914), an interleukin-1α and β inhibitor, is in development for the treatment of RP.","[{'ForeName': 'Allan L', 'Initials': 'AL', 'LastName': 'Klein', 'Affiliation': 'Department of Cardiovascular Imaging, Center for the Diagnosis and Treatment of Pericardial Diseases, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH. Electronic address: kleina@ccf.org.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Imazio', 'Affiliation': 'University Cardiology, Cardiovascular and Thoracic Department, AOU Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Brucato', 'Affiliation': 'Department of Biomedical and Clinical Science, University of Milano, Fatebenefratelli Hospital, Milan, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Cremer', 'Affiliation': 'Department of Cardiovascular Imaging, Center for the Diagnosis and Treatment of Pericardial Diseases, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'LeWinter', 'Affiliation': 'Cardiology Unit, The University of Vermont Medical Center, The University of Vermont, Burlington, VT.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, MN.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'University of Genoa and G. Gaslini Institute, Genoa, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Beutler', 'Affiliation': 'Kiniksa Pharmaceuticals Ltd., Hamilton, Bermuda.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'NJS Associates, Bridgewater, NJ.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Kiniksa Pharmaceuticals Corp., Lexington, MA.'}, {'ForeName': 'Anais', 'Initials': 'A', 'LastName': 'Gervais', 'Affiliation': 'Kiniksa Pharmaceuticals Corp., Lexington, MA.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Perrin', 'Affiliation': 'Kiniksa Pharmaceuticals Corp., Lexington, MA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Paolini', 'Affiliation': 'Kiniksa Pharmaceuticals Corp., Lexington, MA.'}]",American heart journal,['10.1016/j.ahj.2020.07.004']
1821,32845892,"Are gamers better laparoscopic surgeons? Impact of gaming skills on laparoscopic performance in ""Generation Y"" students.","BACKGROUND


Both laparoscopic surgery and computer games make similar demands on eye-hand coordination and visuospatial cognitive ability. A possible connection between both areas could be used for the recruitment and training of future surgery residents.
AIM


The goal of this study was to investigate whether gaming skills are associated with better laparoscopic performance in medical students.
METHODS


135 medical students (55 males, 80 females) participated in an experimental study. Students completed three laparoscopic tasks (rope pass, paper cut, and peg transfer) and played two custom-designed video games (2D and 3D game) that had been previously validated in a group of casual and professional gamers.
RESULTS


There was a small significant correlation between performance on the rope pass task and the 3D game, Kendall's τ(111) = -.151, P = .019. There was also a small significant correlation between the paper cut task and points in the 2D game, Kendall's τ(102) = -.180, P = .008. Overall laparoscopic performance was also significantly correlated with both the 3D game, Kendall's τ(112) = -.134, P = .036, and points in the 2D game, Kendall's τ(113) = -.163, P = .011. However, there was no significant correlation between the peg transfer task and both games (2D and 3D game), P = n.s..
CONCLUSION


This study provides further evidence that gaming skills may be an advantage when learning laparoscopic surgery.",2020,"However, there was no significant correlation between the peg transfer task and both games (2D and 3D game), P = n.s..
CONCLUSION


","['Generation Y"" students', '135 medical students (55 males, 80 females) participated in an experimental study', 'medical students']","['laparoscopic surgery and computer games', 'gaming skills', 'laparoscopic tasks (rope pass, paper cut, and peg transfer) and played two custom-designed video games (2D and 3D game) that had been previously validated in a group of casual and professional gamers']","['laparoscopic performance', 'Overall laparoscopic performance', 'peg transfer task and both games (2D and 3D game']","[{'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",135.0,0.0892581,"However, there was no significant correlation between the peg transfer task and both games (2D and 3D game), P = n.s..
CONCLUSION


","[{'ForeName': 'Rabi', 'Initials': 'R', 'LastName': 'Datta', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Seung-Hun', 'Initials': 'SH', 'LastName': 'Chon', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dratsch', 'Affiliation': 'University of Cologne, Cologne, Germany.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Timmermann', 'Affiliation': 'University of Cologne, Cologne, Germany.'}, {'ForeName': 'Luise', 'Initials': 'L', 'LastName': 'Müller', 'Affiliation': 'University of Cologne, Cologne, Germany.'}, {'ForeName': 'Patrick Sven', 'Initials': 'PS', 'LastName': 'Plum', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Haneder', 'Affiliation': 'Institute of Diagnostic and Interventional Radiology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pinto Dos Santos', 'Affiliation': 'Institute of Diagnostic and Interventional Radiology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin Richard', 'Initials': 'MR', 'LastName': 'Späth', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Wahba', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Christiane Josephine', 'Initials': 'CJ', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kleinert', 'Affiliation': 'Department of General, Visceral, Cancer, and Transplant Surgery, University Hospital of Cologne, Cologne, Germany.'}]",PloS one,['10.1371/journal.pone.0232341']
1822,32853647,Effect of long-term testosterone therapy on molecular regulators of skeletal muscle mass and fibre-type distribution in aging men with subnormal testosterone.,"BACKGROUND


Long-term testosterone replacement therapy (TRT) increases muscle mass in elderly men with subnormal testosterone levels. However, the molecular mechanisms underlying this effect of TRT on protein balance in human skeletal muscle in vivo remain to be established.
METHODS


Here, we examined skeletal muscle biopsies obtained before and 24-h after the last dose of treatment with either testosterone gel (n = 12) or placebo (n = 13) for 6 months in aging men with subnormal bioavailable testosterone levels. The placebo-controlled, testosterone-induced changes (β-coefficients) in mRNA levels, protein expression and phosphorylation were examined by quantitative real-time PCR and western blotting.
RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors. However, TRT caused a sustained decrease in protein expression of SMAD2 (β = -36%, p = 0.004) and SMAD3 (β = -32%, p = 0.001), which was accompanied by reduced protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1 (β = -26%, p = 0.004) and Atrogin-1/MAFbx (β = -20%, p = 0.04), but with no changes in FOXO3 signalling. Importantly, TRT did not affect muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres.
CONCLUSIONS


Our results indicate that long-term TRT of elderly men with subnormal testosterone levels increases muscle mass, at least in part, by decreasing protein breakdown through the ubiquitin proteasome pathway mediated by a sustained suppression of SMAD-signalling and muscle-specific E3-ubiquitin ligases.",2020,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","['aging men with subnormal testosterone', 'elderly men with subnormal testosterone levels']","['testosterone replacement therapy (TRT', 'long-term testosterone therapy', 'placebo', 'testosterone gel', 'TRT']","['muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres', 'protein expression of SMAD2', 'Atrogin-1/MAFbx', 'muscle mass', 'skeletal muscle mass and fibre-type distribution', 'protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1', 'mRNA levels, protein expression and phosphorylation', 'mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1566790', 'cui_str': 'SMAD2 protein, human'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0041538', 'cui_str': 'Ubiquitin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0050668', 'cui_str': 'Activin hormone'}, {'cui': 'C0076925', 'cui_str': 'USF Transcription Factors'}]",,0.0809258,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","[{'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Kruse', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Stine J', 'Initials': 'SJ', 'LastName': 'Petersson', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Louise L', 'Initials': 'LL', 'LastName': 'Christensen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Kristensen', 'Affiliation': 'Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark; Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-2100 Copenhagen, Denmark.'}, {'ForeName': 'Rugivan', 'Initials': 'R', 'LastName': 'Sabaratnam', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Ørtenblad', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, DK-5230 Odense, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Højlund', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark. Electronic address: kurt.hoejlund@rsyd.dk.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154347']
1823,32853672,Safety and effectiveness of azithromycin in patients with COVID-19: An open-label randomised trial.,"As no specific pharmacological treatment has been validated for use in coronavirus disease 2019 (COVID-19), we aimed to assess the effectiveness of azithromycin (AZM) in these patients at a referral centre in Iran. An open-label, randomised controlled trial was conducted on patients with laboratory-confirmed COVID-19. A total of 55 patients in the control group receiving hydroxychloroquine (HCQ) and lopinavir/ritonavir (LPV/r) were compared with 56 patients in the case group who in addition to the same regimen also received AZM. Patients with prior cardiac disease were excluded from the study. Furthermore, patients from the case group were assessed for cardiac arrythmia risk based on the American College of Cardiology (ACC) risk assessment for use of AZM and HCQ. The main outcome measures were vital signs, SpO 2  levels, duration of hospitalisation, need for and length of intensive care unit admission, mortality rate and results of 30-day follow-up after discharge. Initially, there was no significant difference between the general conditions and vital signs of the two groups. The SpO 2  levels at discharge were significantly higher, the respiratory rate was lower and the duration of admission was shorter in the case group. There was no significant difference in the mortality rate between the two groups. Patients who received AZM in addition to HCQ and LPV/r had a better general condition. HCQ+AZM combination may be beneficial for individuals who are known to have a very low underlying risk for cardiac arrhythmia based on the ACC criteria.",2020,"The SpO2 levels at discharge were significantly higher, the respiratory rate was lower, and the duration of admission was shorter in the case group.","['patients at a referral center in Iran', 'Patients with COVID-19', 'Patients with prior cardiac disease', 'patients with laboratory confirmed COVID-19']","['hydroxychloroquine', 'azithromycin and hydroxychloroquine', 'azithromycin', 'hydroxychloroquine-azithromycin', 'hydroxychloroquine and lopinavir / ritonavir', 'Azithromycin']","['respiratory rate', 'duration of admission', 'mortality rate', 'SpO2 levels at discharge', 'cardiac arrythmia risk', 'vital signs, SpO2 levels, duration of hospitalization, need for and length of intensive care unit (ICU) admission, mortality rates, and results of 30-day follow-up after discharge', 'general conditions and vital signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0611014,"The SpO2 levels at discharge were significantly higher, the respiratory rate was lower, and the duration of admission was shorter in the case group.","[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Sekhavati', 'Affiliation': 'Department of Cardiology, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jafari', 'Affiliation': 'Mazandaran University of Medical Sciences, School of Medicine, Sari, Iran; Iran University of Medical Sciences, School of Medicine, Tehran, Iran. Electronic address: fatemejafari72@gmail.com.'}, {'ForeName': 'SeyedAhmad', 'Initials': 'S', 'LastName': 'SeyedAlinaghi', 'Affiliation': 'Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeidreza', 'Initials': 'S', 'LastName': 'Jamalimoghadamsiahkali', 'Affiliation': 'Department of Infectious Diseases, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sadr', 'Affiliation': 'Mazandaran University of Medical Sciences, School of Medicine, Sari, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Tabarestani', 'Affiliation': 'Medical Students Research Committee, Mazandaran University of Medical Sciences, School of Medicine, Sari, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Pirhayati', 'Affiliation': 'Iran University of Medical Sciences, School of Medicine, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Zendehdel', 'Affiliation': 'Geriatric Department, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Manafi', 'Affiliation': 'Iran University of Medical Sciences, School of Medicine, Tehran, Iran.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Hajiabdolbaghi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Ahmadinejad', 'Affiliation': 'Liver Transplantation Research Center, Department of Infectious Diseases, Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran University of Medical Sciences, Tehran 14197-33141, Iran.'}, {'ForeName': 'Hamid Emadi', 'Initials': 'HE', 'LastName': 'Kouchak', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sirous', 'Initials': 'S', 'LastName': 'Jafari', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Seifi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh Shahmari', 'Initials': 'FS', 'LastName': 'Golestan', 'Affiliation': 'Department of Infectious Diseases, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Ghiasvand', 'Affiliation': 'Liver Transplantation Research Center, Department of Infectious Diseases, Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran University of Medical Sciences, Tehran 14197-33141, Iran. Electronic address: ghiasvand_62@yahoo.com.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2020.106143']
1824,32853691,Development and validation of screening scores of non-alcoholic fatty liver disease in middle-aged and elderly Chinese.,"AIM


Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver disease and also closely related to cardiometabolic disease. Its prevalence was estimated at over one-fourth in the general population in China. We aimed to develop effective score tools for detecting NAFLD.
METHODS


A total of 17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis. All participants were randomly classified into the exploratory group or the validation group. Candidate categorical variables were selected using a logistic regression model. The score points were generated according to the β-coefficients.
RESULTS


We developed the Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I), which included body mass index and waist circumference with an area under the receiver-operating characteristic curve (AUC) of 0.802 (95% CI 0.792-0.811) in the exploratory group and 0.802 (95% CI 0.793-0.812) in the validation group. We further developed the SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC of 0.852 (95% CI 0.843-0.861) in the exploratory group and 0.843 (95% CI 0.834-0.852) in the validation group. The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
CONCLUSIONS


Based on anthropometric and clinical categorical variables, our two scores are effective tools for detecting NAFLD in both this southern Chinese population and their subpopulation with normal ALT levels.",2020,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","['subjects with normal alanine aminotransferase (ALT) levels', 'middle-aged and elderly Chinese', '17,212 participants aged 45-70 years old were surveyed in Shanghai between 2013 and 2014, and 13,293 participants were included in this analysis']",[],"['Shanghai Nicheng NAFLD Score I (SHNC NAFLD Score I', 'SHNC NAFLD Score II by adding fasting plasma glucose, triglyceride, and alanine aminotransferase/aspartate aminotransferase ratio to the SHNC NAFLD Score I, achieving an AUC']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",17212.0,0.0822862,"The two score tools also performed well in subjects with normal alanine aminotransferase (ALT) levels.
","[{'ForeName': 'Yebei', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': ""Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Xuhong', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: houxuhong@sjtu.edu.cn.""}, {'ForeName': 'Peizhu', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Fusong', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Lichang', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': ""Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Huaiyu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Prevention and Health Care, Shanghai Jiao Tong University Affiliated Sixth People's Hospital East, 222 Huanhu Xisan Road, Shanghai 201306, China.""}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China; Shanghai Diabetes Institute, 600 Yishan Road, Shanghai 200233, China; Shanghai Clinical Center for Diabetes, 600 Yishan Road, Shanghai 200233, China; Shanghai Key Laboratory of Diabetes Mellitus, 600 Yishan Road, Shanghai 200233, China. Electronic address: wpjia@sjtu.edu.cn.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108385']
1825,32856597,Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic: Prospective Trial.,"BACKGROUND


The Onduo virtual diabetes clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote personalized lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices for intermittent use.
OBJECTIVE


This prospective single-arm study evaluated glycemic outcomes associated with participation in the Onduo VDC for 4 months.
METHODS


Adults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019. Participants were asked to engage at ≥1 time per week with their care team and to participate in a telemedicine consultation with a clinic endocrinologist for diabetes medication review. Participants were asked to use a RT-CGM device and wear six 10-day sensors (total 60 days of sensor wear) intermittently over the course of 4 months. The primary outcome was change in HbA1c at 4 months from baseline. Other endpoints included change in weight and in RT-CGM glycemic metrics, including percent time <70, 70-180, 181-250, and >250 mg/dL. Changes in blood pressure and serum lipids at 4 months were also evaluated.
RESULTS


Participants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female. HbA1c decreased significantly by 1.6% (SD 1%; P<.001). When stratified by baseline HbA1c of 8.0% to 9.0% (n=36) and >9.0% (n=19), HbA1c decreased by 1.2% (SD 0.6%; P<.001) and 2.4% (SD 1.3%; P<.001), respectively. Continuous glucose monitoring-measured (n=43) percent time in range (TIR) 70-180 mg/dL increased by 10.2% (SD 20.5%; P=.002), from 65.4% (SD 23.2%) to 75.5% (SD 22.7%), which was equivalent to a mean increase of 2.4 hours TIR per day. Percent time 181-250 mg/dL and >250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively. There was no change in percent time <70 mg/dL. Mean weight decreased by 9.0 lb (SD 10.4; P<.001). Significant improvements were also observed in systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P=.04 to P=<.001).
CONCLUSIONS


Participants in the Onduo VDC experienced significant improvement in HbA1c, increased TIR, decreased time in hyperglycemia, and no increase in hypoglycemia at 4 months. Improvements in other metabolic health parameters including weight and blood pressure were also observed. In conclusion, the Onduo VDC has potential to support people with T2D and their clinicians between office visits by increasing access to specialty care and advanced diabetes technology including RT-CGM.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381.",2020,">250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively.","['people with type 2 diabetes (T2D', 'Participants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female', 'Adults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019', 'Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic']",['telemedicine consultation with a clinic endocrinologist'],"['systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides', 'change in HbA1c', 'weight and blood pressure', 'hypoglycemia', 'HbA1c, increased TIR, decreased time in hyperglycemia', 'Mean weight', 'Glycemic Outcomes', 'Continuous glucose monitoring-measured (n=43) percent time in range (TIR', 'blood pressure and serum lipids', 'change in weight and in RT-CGM glycemic metrics', 'HbA1c']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0259863', 'cui_str': 'Endocrinologist'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",55.0,0.151487,">250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively.","[{'ForeName': 'Amit R', 'Initials': 'AR', 'LastName': 'Majithia', 'Affiliation': 'Department of Medicine and Department of Pediatrics, University of California San Diego School of Medicine, La Jolla, CA, United States.'}, {'ForeName': 'Coco M', 'Initials': 'CM', 'LastName': 'Kusiak', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Armento Lee', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'Francis R', 'Initials': 'FR', 'LastName': 'Colangelo', 'Affiliation': 'Allegheny Health Network, Monroeville, PA, United States.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Romanelli', 'Affiliation': 'Sutter Health, Palo Alto, CA, United States.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Robertson', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Miller', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Erani', 'Affiliation': 'Onduo Professionals, PC, Newton, MA, United States.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Layne', 'Affiliation': 'Onduo, LLC, Newton, MA, United States.'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'Dixon', 'Affiliation': 'Onduo, LLC, Newton, MA, United States.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Zisser', 'Affiliation': 'Verily Life Sciences, South San Francisco, CA, United States.'}]",Journal of medical Internet research,['10.2196/21778']
1826,32856605,Asian Race and Risk of Prostate Cancer: Results from the REDUCE Study.,"BACKGROUND


Global prostate cancer incidence rates are lower in Asian men than Caucasian men. Whether this is the result of less screening in Asian men remains to be determined. We examined whether Asian race was associated with prostate cancer diagnosis in the Reduction by Dutasteride of Cancer Events (REDUCE) study.
METHODS


REDUCE was a 4-year, multicenter, randomized trial of dutasteride versus placebo for prostate cancer prevention among men who underwent prostate-specific antigen (PSA)-independent biopsies at 2 and 4 years. Eligible men were ages 50 to 75 years, had PSA between 2.5 and 10 ng/mL, and a negative prestudy prostate biopsy. We tested the association between Asian and Caucasian race and prostate cancer diagnosis using logistic regression.
RESULTS


Of 8,122 men in REDUCE, 5,755 (71%) were Caucasian and 105 (1.8%) were Asian. Asians had lower body mass index (24.8 vs. 26.9 kg/m 2 ,  P  < 0.001), had smaller prostate volume (35.0 vs. 43.5 cc,  P  < 0.001), and were less likely to have abnormal digital rectal exams ( P  = 0.048), but were similar in baseline age, PSA, family history of prostate cancer, and smoking status compared with Caucasian men (all  P  ≥ 0.164). Asian men were equally likely to receive any on-study biopsy compared with Caucasian men ( P  = 0.634). After adjusting for potential confounders, Asian men were less likely to be diagnosed with prostate cancer during the 4-year study (OR = 0.49; 95% confidence interval, 0.28-0.88;  P  = 0.016), compared with Caucasian men.
CONCLUSIONS


In REDUCE, where all men underwent biopsies largely independent of PSA, Asian race was associated with lower prostate cancer diagnosis.
IMPACT


These findings suggest that lower prostate cancer risk in Asian men may be due to biological, genetic, and/or lifestyle factors.",2020,Asian men were equally likely to receive any on-study biopsy compared to Caucasian men (p=0.634).,"['Eligible men were aged 50-75 years, had PSA between 2.5-10 ng/mL, and a negative pre-study prostate biopsy', 'Of 8,122 men in REDUCE, 5,755 (71%) were Caucasian and 105 (1.8%) were Asian', 'men who underwent PSA-independent biopsies at 2- and 4-years', 'Asian race and risk of prostate cancer', 'Asian men than Caucasian men', 'Asian men']",['dutasteride vs. placebo'],"['abnormal digital rectal exam', 'body mass index', 'smaller prostate volume']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0199900', 'cui_str': 'Rectal examination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0426733', 'cui_str': 'Small prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0674668,Asian men were equally likely to receive any on-study biopsy compared to Caucasian men (p=0.634).,"[{'ForeName': 'Adriana C', 'Initials': 'AC', 'LastName': 'Vidal', 'Affiliation': 'Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Center for Integrated Research on Cancer and Lifestyle, Los Angeles, California. adriana.vidal@cshs.org.'}, {'ForeName': 'Taofik', 'Initials': 'T', 'LastName': 'Oyekunle', 'Affiliation': 'Surgery Section, Durham VA Medical Center, Durham, North Carolina.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Center for Integrated Research on Cancer and Lifestyle, Los Angeles, California.'}, {'ForeName': 'Alexis R', 'Initials': 'AR', 'LastName': 'Freedland', 'Affiliation': 'Department of Epidemiology, UCI School of Medicine, University of California at Irvine, Irvine, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Moreira', 'Affiliation': 'Department of Urology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Castro-Santamaria', 'Affiliation': 'Ohana Biosciences, Cambridge, Massachusetts.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'Andriole', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Center for Integrated Research on Cancer and Lifestyle, Los Angeles, California.'}, {'ForeName': 'Emma H', 'Initials': 'EH', 'LastName': 'Allott', 'Affiliation': ""Patrick G Johnston Centre for Cancer Research, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.""}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-20-0646']
1827,32858227,"The impact of Geriatric Emergency Department Innovations (GEDI) on health services use, health related quality of life, and costs: Protocol for a randomized controlled trial.","BACKGROUND AND OBJECTIVES


Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits. These ED visits are sentinel health events as discharged patients often return to the ED, experience declines in health-related quality of life (HRQoL) and disability, or are later hospitalized. Those who are admitted incur increased costs and greater risk for poor outcomes including infections, delirium, and falls. The objective of this randomized controlled trial (RCT) is to evaluate the efficacy of the Geriatric Emergency Department Innovations (GEDI) program, an ED nurse-led geriatric assessment and care coordination program, in decreasing unnecessary health services use and improving Health-Related Quality-of-Life (HRQoL) for older adults in the ED.
METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420). Outcome variables will be assessed during the ED visit and at 7-11 days and 28-32 days post ED visit.
PROJECTED OUTCOMES


The primary outcome is hospitalization or death within 30 days of the ED visit. Secondary outcomes include health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression].
TRIAL REGISTRATION


Clinicaltrials.Gov identifier NCT04115371.",2020,"METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","['Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either', 'older adults in the ED', 'Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits']","['Geriatric Emergency Department Innovations (GEDI', 'GEDI (n\u202f=\u202f420) or to usual ED care']","['health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression', 'hospitalization or death within 30\u202fdays of the ED visit', 'infections, delirium, and falls', 'Health-Related Quality-of-Life (HRQoL']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4517774', 'cui_str': '420'}]","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.106207,"METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","[{'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Dresden', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: sdresden@nm.org.'}, {'ForeName': 'Alexander X', 'Initials': 'AX', 'LastName': 'Lo', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Lindquist', 'Affiliation': 'Department of Internal Medicine, Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Kocherginsky', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lori Ann', 'Initials': 'LA', 'LastName': 'Post', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'French', 'Affiliation': 'Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, USA; Department of Veterans Affairs Health Services Research and Development Service, Edward Hines, Jr. VA Hospital, Hines, IL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gray', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Heinemann', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University and Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106125']
1828,32860344,Six-Month Follow-up from a Randomized Controlled Trial of the Weight BIAS Program.,"OBJECTIVE


The aim of this study was to investigate the 6-month nonintervention follow-up effects of a cognitive behavioral intervention for weight bias internalization (WBI; i.e., self-stigma) combined with behavioral weight loss (BWL).
METHODS


Adults with obesity and elevated WBI were previously randomized to receive BWL alone or in combination with the Weight Bias Internalization and Stigma program (BWL + BIAS). Participants attended weekly group meetings for 12 weeks, followed by two biweekly and two monthly meetings (26 weeks total). Follow-up assessments were conducted at week 52. Changes on the Weight Bias Internalization Scale and Weight Self-Stigma Questionnaire at week 52 were the principal outcomes. Other outcomes included changes in eating, coping, and weight.
RESULTS


Of 72 randomized participants, 54 (75%) completed week 52 assessments. Linear mixed models showed improvements across groups, but no significant differences between groups, in week 52 change on the Weight Bias Internalization Scale (P = 0.25) or Weight Self-Stigma Questionnaire (P = 0.27). BWL + BIAS participants reported significantly greater benefits than BWL participants on measures of eating and affective coping with weight stigma. Percent weight loss at week 52 did not differ significantly between groups (BWL + BIAS = -3.1% [SE 1.0%], BWL = -4.0% [SE 1.0%], P = 0.53).
CONCLUSIONS


Reductions in WBI did not differ between groups at 6-month follow-up. Further research is needed to determine the potential benefits of a stigma-reduction intervention beyond BWL.",2020,"Linear mixed models showed improvements across groups, but no significant differences between groups, in week 52 change on the Weight Bias Internalization Scale (P = 0.25) or Weight Self-Stigma Questionnaire (P = 0.27).","['Adults with obesity and elevated WBI', 'Of 72 randomized participants, 54 (75']","['behavioral weight loss (BWL', 'BWL alone or in combination with the Weight Bias Internalization and Stigma program (BWL\u2009+\u2009BIAS', 'cognitive behavioral intervention']","['Weight Bias Internalization Scale', 'Percent weight loss', 'Weight Bias Internalization Scale and Weight Self-Stigma Questionnaire', 'changes in eating, coping, and weight', 'Weight Self-Stigma Questionnaire', 'WBI', 'eating and affective coping with weight stigma']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",72.0,0.0480705,"Linear mixed models showed improvements across groups, but no significant differences between groups, in week 52 change on the Weight Bias Internalization Scale (P = 0.25) or Weight Self-Stigma Questionnaire (P = 0.27).","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Pearl', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bach', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jena S', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22931']
1829,32861015,Cognitive behavioral therapy for insomnia in restless legs syndrome patients.,"OBJECTIVES


The purpose of this study was to investigate the effects of cognitive behavioral therapy for insomnia (CBTI) in patients with Restless Legs Syndrome (RLS).
METHODS


This is a randomized controlled study. The patients were sequentially selected and randomly assigned to either a CBTI group or a non-CBTI group. A total of 25 RLS patients with comorbid insomnia were recruited from a tertiary university hospital sleep center. Twelve were assigned to the CBTI group, and 13 were assigned to the non-CBTI group. The CBTI group received 4 sessions of behavioral therapy, while the non-CBTI group received one informative session on sleep hygiene. All patients completed sleep and psychiatric-related questionnaires. In addition, each individual completed a one-week sleep log for collecting subjective sleep data and actigraphy for objective sleep data.
RESULTS


After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group. The effect of CBTI on sleep-related data was maintained for up to three months.
CONCLUSIONS


CBTI was effective in RLS patients by improving sleep quality and anxiety symptoms. CBTI may be considered in clinical practice for RLS patients with comorbid insomnia.",2020,"After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group.","['restless legs syndrome patients', 'patients with Restless Legs Syndrome (RLS', 'RLS patients with comorbid insomnia', '25 RLS patients with comorbid insomnia were recruited from a tertiary university hospital sleep center']","['CBTI', 'CBTI group or a non-CBTI', 'cognitive behavioral therapy', 'Cognitive behavioral therapy']","['sleep quality and anxiety symptoms', 'severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety']","[{'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",25.0,0.0273384,"After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group.","[{'ForeName': 'Mei Ling', 'Initials': 'ML', 'LastName': 'Song', 'Affiliation': 'College of Nursing, Daegu Health College, Daegu, South Korea; College of Nursing, Keimyung University, Daegu, South Korea.'}, {'ForeName': 'Kyung Min', 'Initials': 'KM', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Keimyung University, Daegu, South Korea. Electronic address: kmp@kmu.ac.kr.'}, {'ForeName': 'Gholam K', 'Initials': 'GK', 'LastName': 'Motamedi', 'Affiliation': 'Department of Neurology, Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Yong Won', 'Initials': 'YW', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Keimyung University, School of Medicine, Daegu, South Korea. Electronic address: neurocho@gmail.com.'}]",Sleep medicine,['10.1016/j.sleep.2020.07.011']
1830,32861197,"Gut mycobiome and its interaction with diet, gut bacteria and alzheimer's disease markers in subjects with mild cognitive impairment: A pilot study.","BACKGROUND


Recently, we reported that patients with mild cognitive impairment (MCI) harbor specific signature of bacteria in their gut and that a modified Mediterranean ketogenic diet (MMKD) improves Alzheimer's disease (AD) markers in cerebrospinal fluid (CSF) and the signatures of gut bacteria. However, other microbial population such as gut fungi (mycobiome) in relation to MCI/AD pathology, gut bacteria and diet remain unknown.
METHODS


We measure gut mycobiome by sequencing of the fungal rRNA ITS1 gene in 17 older adults (11 MCI; 6 cognitively normal [CN]) in a single-center, randomized, double-blind, crossover pilot study, before and after 6 weeks intervention of MMKD and American Heart Association Diet (AHAD), and determine its correlation with AD markers in CSF and gut bacteria.
FINDINGS


Compared to CN counterparts, patients with MCI have higher proportion of families Sclerotiniaceae, Phaffomyceteceae, Trichocomaceae, Cystofilobasidiaceae, Togniniaceae and genera Botrytis, Kazachstania, Phaeoacremonium and Cladosporium and lower abundance of Meyerozyma. Specific fungal taxa exhibit distinct correlation arrays with AD markers and gut bacteria in subjects with versus without MCI. MMKD induces broader effect on fungal diversity in subjects with MCI and increases Agaricus and Mrakia while decreasing Saccharomyces and Claviceps with differential response in subjects with or without MCI.
INTERPRETATION


The study reveals MCI-specific mycobiome signatures and demonstrates that distinct diets modulate the mycobiome in association with AD markers and fungal-bacterial co-regulation networks in patients with MCI. The findings corroborate the notion of considering gut mycobiome as a unique factor that can affect cognitive health/AD by interacting with gut bacteria and diet and facilitate better understanding of the AD and related microbiome, using unique diet or microbiome modulators.",2020,"MMKD induces broader effect on fungal diversity in subjects with MCI and increases Agaricus and Mrakia while decreasing Saccharomyces and Claviceps with differential response in subjects with or without MCI.
","['subjects with versus without MCI', 'subjects with mild cognitive impairment', 'patients with mild cognitive impairment (MCI', 'patients with MCI', '17 older adults (11 MCI; 6 cognitively normal [CN']","['Mediterranean ketogenic diet (MMKD', 'MMKD and American Heart Association Diet (AHAD']","['families Sclerotiniaceae, Phaffomyceteceae, Trichocomaceae, Cystofilobasidiaceae, Togniniaceae and genera Botrytis, Kazachstania, Phaeoacremonium and Cladosporium and lower abundance of Meyerozyma']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1002379', 'cui_str': 'Sclerotiniaceae'}, {'cui': 'C1002104', 'cui_str': 'Trichocomaceae'}, {'cui': 'C0006040', 'cui_str': 'Botrytis'}, {'cui': 'C1085204', 'cui_str': 'Kazachstania'}, {'cui': 'C1025333', 'cui_str': 'Phaeoacremonium'}, {'cui': 'C0008886', 'cui_str': 'Cladosporium'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3008845', 'cui_str': 'Meyerozyma'}]",17.0,0.0319494,"MMKD induces broader effect on fungal diversity in subjects with MCI and increases Agaricus and Mrakia while decreasing Saccharomyces and Claviceps with differential response in subjects with or without MCI.
","[{'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Nagpal', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Neth', 'Affiliation': 'Department of Internal Medicine- Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Neurology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Sidharth P', 'Initials': 'SP', 'LastName': 'Mishra', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': 'Department of Internal Medicine- Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States. Electronic address: suzcraft@wakehealth.edu.'}, {'ForeName': 'Hariom', 'Initials': 'H', 'LastName': 'Yadav', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States. Electronic address: hyadav@wakehealth.edu.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102950']
1831,32861897,Testing an app-based intervention to improve insomnia in patients with epilepsy: A randomized controlled trial.,"PURPOSE


Insomnia has adverse effects on people with epilepsy. We aimed to test a novel cognitive behavioral therapy for insomnia (CBT-I) app-based intervention on insomnia symptoms and social psychological factors in people with epilepsy and to examine the possible mechanisms among the factors.
METHODS


Participants were recruited from neurology clinics in Iran and comprised individuals diagnosed with epilepsy and having moderate to severe insomnia. A two-arm randomized controlled trial design was used, consisting of a treatment group (CBT-I; n = 160) and control group (patient education; n = 160). Primary outcomes were self-reported sleep quality, insomnia severity, and sleep hygiene behavior and objective sleep characteristics measured by actigraphy. Secondary outcomes were attitude, perceived behavioral control, intention, action planning, coping planning, behavioral automaticity, self-monitoring, anxiety, depression, and quality of life (QoL). All outcomes were measured at baseline, and at one, three, and six months postintervention, except objective sleep, which was assessed at baseline, and one and six months postintervention. Data were analyzed using linear mixed models.
RESULTS


Current findings showed that sleep quality, insomnia severity, sleep hygiene behavior, and sleep onset latency were significantly improved in the CBT-I group compared with the patient education group at all measurement points. Also, the CBT-I group had significantly improved anxiety, depression, and QoL compared with the patient education group. Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes.
CONCLUSION


Results support the use of the CBT-I app to improve sleep outcomes among people with epilepsy.",2020,"Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes.
","['patients with epilepsy', 'people with epilepsy', 'Participants were recruited from neurology clinics in Iran and comprised individuals diagnosed with epilepsy and having moderate to severe insomnia']","['Testing an app-based intervention', 'novel cognitive behavioral therapy for insomnia (CBT-I) app-based intervention']","['insomnia symptoms and social psychological factors', 'sleep quality, insomnia severity, sleep hygiene behavior, and sleep onset latency', 'attitude, intention, coping planning, self-monitoring, and behavioral automaticity', 'anxiety, depression, and QoL', 'self-reported sleep quality, insomnia severity, and sleep hygiene behavior and objective sleep characteristics measured by actigraphy', 'attitude, perceived behavioral control, intention, action planning, coping planning, behavioral automaticity, self-monitoring, anxiety, depression, and quality of life (QoL', 'sleep outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0878237,"Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes.
","[{'ForeName': 'Daniel Kwasi', 'Initials': 'DK', 'LastName': 'Ahorsu', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health & Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health & Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Imani', 'Affiliation': 'Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Nygårdh', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Broström', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden; Department of Clinical Neurophysiology, University Hospital, Linköping, Sweden.'}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Hamilton', 'Affiliation': 'School of Applied Psychology, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden; Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: Pakpour_Amir@yahoo.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107371']
1832,32861904,Comparison of Clinical and Radiologic Outcome Between Mini-Open Wiltse Approach and Fluoroscopic-Guided Percutaneous Pedicle Screw Placement: A Randomized Controlled Trial.,"OBJECTIVE


To compare clinical efficacy, radiographic outcome, and radiation exposure between mini-open pedicle screw (MPS) fixation with the Wiltse approach and percutaneous pedicle screw (PPS) fixation in treatment of young and middle-aged patients with thoracolumbar burst fractures.
METHODS


Of 60 patients with thoracolumbar vertebrae fractures treated in our hospital from January 2017 to January 2018, 30 were randomly assigned to the MPS group and 30 were randomly assigned to the PPS group. Clinical efficacy, radiographic outcome, and radiation exposure were compared between the 2 groups.
RESULTS


The average age of patients was 42.2 ± 6.7 years in the MPS group and 43.0 ± 6.9 years in the PPS group (P = 0.668). There was no significant difference between the 2 groups in blood loss, hospital stay, postoperative visual analog scale score for back pain, and Oswestry Disability Index score. The vertebral body height and vertebral body angle of the MPS group were significantly better than those of the PPS group at the last follow-up. There was no significant difference in the accuracy rate of pedicle screw placement between the MPS group and the PPS group; the facet joint violation was significantly higher in the PPS group. The average radiation exposure dosage was lower in the MPS group.
CONCLUSIONS


Both MPS fixation with the Wiltse approach and PPS fixation are safe and effective in the treatment of single-segment thoracolumbar vertebral fractures. Nevertheless, considering the surgical duration, radiation exposure, facet joint violation, vertebral body height, and vertebral body angle at the last follow-up, MPS fixation with the Wiltse approach is a better choice than PPS.",2020,"There was no significant difference in the blood loss, hospital stay, postoperative VAS for back pain, and ODI between the two groups.","['young and middle-aged patients with thoracolumbar burst fractures', 'Sixty patients with thoracolumbar vertebrae fractures treated in our hospital from January 2017 to January 2018']","['PPS) fixation', 'MPS group and PPS', 'mini-open Wiltse approach and fluoroscopic-guided percutaneous pedicle screw placement', 'MPS fixation with Wiltse approach and PPS fixation', 'mini-open pedicle screw (MPS) fixation with Wiltse approach and percutaneous pedicle screw']","['facet joint violation (FJV', 'accuracy rate of pedicle screw placement', 'VBH and VBA', 'clinical efficacy, radiographic outcome, and radiation exposure', 'surgical duration, radiation exposure, FJV, VBH, and VBA', 'average radiation exposure dosage', 'blood loss, hospital stay, postoperative VAS for back pain, and ODI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0859903', 'cui_str': 'Burst fracture'}, {'cui': 'C1267077', 'cui_str': 'Thoracolumbar vertebrae'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0224521', 'cui_str': 'Zygapophyseal joint structure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",60.0,0.0161646,"There was no significant difference in the blood loss, hospital stay, postoperative VAS for back pain, and ODI between the two groups.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zou', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jun-Song', 'Initials': 'JS', 'LastName': 'Yang', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiang-Fu', 'Initials': 'XF', 'LastName': 'Wang', 'Affiliation': 'Department of Spinal Minimally Invasive Surgery, Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou, Gansu, China.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Wei', 'Affiliation': 'Department of Spine Surgery, Baoji City Hospital of Traditional Chinese Medicine, Baoji, Shaanxi, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Ding-Jun', 'Initials': 'DJ', 'LastName': 'Hao', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Qing-Da', 'Initials': 'QD', 'LastName': 'Li', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': 'Department of Gynecology and Obstetrics, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Han-Lin', 'Initials': 'HL', 'LastName': 'Gong', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xu-Cai', 'Initials': 'XC', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesia, Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Ben-Yin', 'Initials': 'BY', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xue-Fang', 'Initials': 'XF', 'LastName': 'Zhang', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yuan-Ting', 'Initials': 'YT', 'LastName': 'Zhao', 'Affiliation': ""Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China. Electronic address: zytqy@163.com.""}]",World neurosurgery,['10.1016/j.wneu.2020.08.145']
1833,32879065,Efficacy of different ways of cocktail analgesic mixture injection on total knee arthroplasty.,"OBJECTIVES


To evaluate the efficacy of different ways of cocktail analgesic mixture injection on total knee arthroplasty (TKA).
METHODS


A total of 50 patients with knee osteoarthritis treated by TKA from July to September 2018 were randomly divided into two groups ( n =25). The Group 1 underwent anterior intra-articular injection before prosthesis implanted while the Group 2 underwent posterior intra-articular injection before prosthesis implanted. Visual Analogue Scale (VAS) of all patients for pain during activity and at rest, maximal flexion degree of the knee at the 48th h and the 72th h after surgery, the time of raise leg, usage rate of patient-controlled analgesia (PCA), and complications were evaluated and analyzed.
RESULTS


VAS for pain at rest of patients in the Group 1 was significantly less than that in the Group 2 at the 6th, 12th, and 24th h after surgery (all  P <0.05). Maximal flexion degree of the knee at the 48th h and the 72th h after surgery in the Group 1 was better than that in the Group 2 (both  P <0.05). The Group 1 costed less time than the Group 2 on the ability to perform an active straight leg raise ( P =0.027).
CONCLUSIONS


The anterior intra-articular cocktail analgesic mixture injection can strongly relieve the pain early after TKA, which can improve knee function and achieve painless rehabilitation in most patients, with safety.",2020,"The Group 1 costed less time than the Group 2 on the ability to perform an active straight leg raise ( P =0.027).
","['50 patients with knee osteoarthritis treated by TKA from July to September 2018', 'total knee arthroplasty']","['cocktail analgesic mixture injection', 'anterior intra-articular injection before prosthesis implanted while the Group 2 underwent posterior intra-articular injection before prosthesis implanted']","['total knee arthroplasty (TKA', 'ability to perform an active straight leg raise', 'Maximal flexion degree of the knee', 'Visual Analogue Scale (VAS', 'time of raise leg, usage rate of patient-controlled analgesia (PCA), and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.0289258,"The Group 1 costed less time than the Group 2 on the ability to perform an active straight leg raise ( P =0.027).
","[{'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Second Department of Joint Disease, Zhengzhou Orthopedics Hospital, Zhengzhou 450052. lkw0903@163.com.'}, {'ForeName': 'Yingzhou', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Second Department of Joint Disease, Zhengzhou Orthopedics Hospital, Zhengzhou 450052.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Second Department of Joint Disease, Zhengzhou Orthopedics Hospital, Zhengzhou 450052.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Second Xiangya Hospital, Central South University, Changsha 410011, China. lizhihong@csu.edu.cn.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.180801']
1834,32879125,Comparison of odontoblast differentiation capacity between stem cells from human exfoliated deciduous teeth and dental pulp stem cells.,"OBJECTIVES


To explore the difference in odontoblast differentiation capacity between stem cells from human exfoliated deciduous teeth (SHED) and dental pulp stem cells (DPSCs), and to examine the expression level of ephrinB1 in odontoblast differentiation of these stem cells.
METHODS


The stems cells were divided into a SHED group and a DPSCs group. After odontoblast differentiation induction, the above 2 groups were also randomly divided into a 3 d group and a 7 d group, respectively.The calcium deposition was detected by alkaline phosphatase (ALP) staining and alizarin red staining.The mRNA and protein expressions of ephrinB1, dentin matrix protein-1 (DMP-1) and dentin sialophosphoprotein (DSPP) were detected by real-time PCR and Western blotting.
RESULTS


ALP staining and alizarin red staining showed that there was stronger mineralization capacity in the SHED group than that in the DPSCs group. The relative mRNA and protein expressions of DMP-1, DSPP, and ephrinB1 in the SHED group were higher than those in the DPSCs group except for the protein expression of DMP-1 in the SHED 3 d group (all  P <0.05).
CONCLUSIONS


SHED has stronger odontoblast differentiation capacity than DPSCs. In addition, ephrinB1 may be involved in the processes of odontoblast differentiation in the SHED and DPSCs.",2020,"The mRNA and protein expressions of ephrinB1, dentin matrix protein-1","['human exfoliated deciduous teeth and dental pulp stem cells', 'human exfoliated deciduous teeth (SHED) and dental pulp stem cells (DPSCs']",[],"['mRNA and protein expressions of ephrinB1, dentin matrix protein-1', 'relative mRNA and protein expressions of DMP-1, DSPP, and ephrinB1', 'DMP-1) and dentin sialophosphoprotein (DSPP', 'calcium deposition', 'mineralization capacity', 'protein expression of DMP-1', 'alkaline phosphatase (ALP) staining and alizarin red staining']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]",[],"[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1531071', 'cui_str': 'DMP1 protein, human'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0914005', 'cui_str': 'dentin sialophosphoprotein'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0051163', 'cui_str': 'alizarin'}]",,0.0185167,"The mRNA and protein expressions of ephrinB1, dentin matrix protein-1","[{'ForeName': 'Caiyu', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Pediatric Dentistry, Affiliated Stomatology Hospital, Chongqing Medical University, Chongqing 401147. 2017110877@stu.cqmu.edu.cn.'}, {'ForeName': 'Leilei', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Pediatric Dentistry, Affiliated Stomatology Hospital, Chongqing Medical University, Chongqing 401147.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatric Dentistry, Affiliated Stomatology Hospital, Chongqing Medical University, Chongqing 401147.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'Department of Pediatric Dentistry, Affiliated Stomatology Hospital, Chongqing Medical University, Chongqing 401147.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Pediatric Dentistry, Affiliated Stomatology Hospital, Chongqing Medical University, Chongqing 401147.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Department of Pediatric Dentistry, Affiliated Stomatology Hospital, Chongqing Medical University, Chongqing 401147.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Pediatric Dentistry, Affiliated Stomatology Hospital, Chongqing Medical University, Chongqing 401147. 500188@hospital.cqmu.edu.cn.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.190102']
1835,32883245,Interventions Made to Preserve Cognitive Function Trial (IMPCT) study protocol: a multi-dialysis center 2x2 factorial randomized controlled trial of intradialytic cognitive and exercise training to preserve cognitive function.,"BACKGROUND


Kidney disease and dialysis significantly impact cognitive function across the age spectrum. Cognitive training (CT) and/or exercise training (ET) are promising approaches to preserve cognitive function among community-dwelling older adults, but have not been tested for cognition preservation in hemodialysis patients of all ages. In this manuscript, we summarize the protocol for the Interventions Made to Preserve Cognitive Function Trial (IMPCT).
METHODS


We will perform a 2 × 2 factorial randomized controlled trial (RCT) of eligible adult (≥18 years) hemodialysis initiates (n = 200) to test whether intradialytic CT (brain games on a tablet PC), ET (foot peddlers) and combined CT + ET while undergoing hemodialysis preserves executive function compared to standard of care (SC). Participants will engage in the interventions to which they are randomized for 6 months. The primary objective is to compare, among interventions, the 3-month change in executive function measured using the Trail Making Test A (TMTA) and B (TMTB); specifically, executive function is calculated as TMTB-TMTA to account for psychomotor speed. This primary outcome was selected based on findings from our pilot study. The secondary objectives are to compare the risk of secondary cognitive outcomes, ESKD-specific clinical outcomes, and patient-centered outcomes at 3-months and 6-months. All data collection and interventions are conducted in the dialysis center.
DISCUSSION


We hypothesize that receiving intradialytic CT or ET will better preserve executive function than SC but receiving combined CT + ET, will be the most effective intervention. The current trial will be an important step in understanding how intradialytic interventions might preserve cognitive health.
TRIAL REGISTRATION


Clinicaltrials.Gov (Date: 8/6/18): # NCT03616535 . Protocol Version: 10 (April 2020).
FUNDING


NIDDK R01DK114074.",2020,"The primary objective is to compare, among interventions, the 3-month change in executive function measured using the Trail Making Test A (TMTA) and B (TMTB); specifically, executive function is calculated as TMTB-TMTA to account for psychomotor speed.","['hemodialysis patients of all ages', 'community-dwelling older adults', 'eligible adult (≥18\u2009years) hemodialysis initiates (n\u2009=\u2009200']","['intradialytic CT (brain games on a tablet PC), ET (foot peddlers) and combined CT\u2009+\u2009ET while undergoing hemodialysis preserves executive function compared to standard of care (SC', 'intradialytic cognitive and exercise training', 'Cognitive training (CT', 'and/or exercise training (ET']","['executive function', 'cognitive function', 'Trail Making Test A (TMTA) and B (TMTB); specifically, executive function', 'risk of secondary cognitive outcomes, ESKD-specific clinical outcomes, and patient-centered outcomes']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",,0.0909873,"The primary objective is to compare, among interventions, the 3-month change in executive function measured using the Trail Making Test A (TMTA) and B (TMTB); specifically, executive function is calculated as TMTB-TMTA to account for psychomotor speed.","[{'ForeName': 'Mara A', 'Initials': 'MA', 'LastName': 'McAdams-DeMarco', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA. mara@jhu.edu.'}, {'ForeName': 'Nadia M', 'Initials': 'NM', 'LastName': 'Chu', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Malu', 'Initials': 'M', 'LastName': 'Steckel', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Kunwar', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Marlís', 'Initials': 'M', 'LastName': 'González Fernández', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Carlson', 'Affiliation': 'Department of Mental Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Fine', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615, N. Wolfe St, W6033, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Diener-West', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Dorry L', 'Initials': 'DL', 'LastName': 'Segev', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",BMC nephrology,['10.1186/s12882-020-02041-y']
1836,32857056,Technology-Assisted Self-Monitoring of Lifestyle Behaviors and Health Indicators in Diabetes: Qualitative Study.,"BACKGROUND


Self-monitoring is key to successful behavior change in diabetes and obesity, and the use of traditional paper-based methods of self-monitoring may be time-consuming and burdensome.
OBJECTIVE


This study aimed to explore participant experiences while using technology-assisted self-monitoring of lifestyle behaviors and health indicators among overweight or obese adults with type 2 diabetes.
METHODS


Qualitative data collected from the intervention group of a 6-month, three-arm (control, paper diary, and technology-assisted self-monitoring groups) randomized clinical trial were analyzed. Study participants in the intervention group monitored their diet, exercise, and weight using the LoseIt! app, and their blood glucose levels using a glucometer and the Diabetes Connect app. Semistructured group discussions were conducted at 6 weeks (n=10) from the initiation of the behavioral lifestyle intervention and again at 6 months (n=9). All group interviews were audiotaped and transcribed verbatim. Using a combination of thematic and comparative analysis approaches, two trained professionals coded the transcriptions independently and then discussed and concluded common themes for the 6-week and 6-month discussions separately.
RESULTS


The sample (n=10), which primarily involved African American participants (n=7) and female participants (n=8), had a mean age of 59.4 years. The following eight themes emerged: (1) perceived benefits of technology-assisted self-monitoring; (2) perceived ease of use (eg, barriers: technical difficulties and lack of self-discipline; facilitators: help from family, friends, and the program); (3) use of technology-assisted self-monitoring; (4) facilitators of engaging in healthy lifestyle behaviors (eg, visualization and awareness of calorie input/expenditure); (5) positive lifestyle change; (6) barriers of engaging in healthy lifestyle behaviors (eg, event influence); (7) learning curve; and (8) monitored data sharing. The first six of these themes were shared between the 6-week and 6-month timepoints, but the codes within these themes were not all the same and differed slightly between the two timepoints. These differences provide insights into the evolution of participant thoughts and perceptions on using technology for self-monitoring and subsequent behavioral lifestyle changes while participating in lifestyle interventions. The findings from the 6-week and 6-month data helped to paint a picture of participant comfort and the integration of technology and knowledge overtime, and clarified participant attitudes, difficulties, behavioral processes, and modifications, as well as health indicators that were experienced throughout the study.
CONCLUSIONS


Although there were some barriers, participants were able to identify various individual and external facilitators to adjust to and engage in technology-assisted self-monitoring, and it was concluded that the technology-assisted self-monitoring approach was beneficial, safe, and feasible to use for positive lifestyle change. These patient perspectives need to be considered in future research studies when investigating the effectiveness of using technology-assisted self-monitoring, as well as in clinical practice when recommending technology-assisted self-monitoring of lifestyle behaviors and health indicators to improve health outcomes.",2020,"Although there were some barriers, participants were able to identify various individual and external facilitators to adjust to and engage in technology-assisted self-monitoring, and it was concluded that the technology-assisted self-monitoring approach was beneficial, safe, and feasible to use for positive lifestyle change.","['overweight or obese adults with type 2 diabetes', 'Diabetes', 'The sample (n=10), which primarily involved African American participants (n=7) and female participants (n=8), had a mean age of 59.4 years']","['diet, exercise, and weight using the LoseIt', 'behavioral lifestyle intervention', 'technology-assisted self-monitoring of lifestyle behaviors', 'technology-assisted self-monitoring; (2) perceived ease of use (eg, barriers: technical difficulties and lack of self-discipline; facilitators: help from family, friends, and the program); (3) use of technology-assisted self-monitoring; (4) facilitators of engaging in healthy lifestyle behaviors (eg, visualization and awareness of calorie input/expenditure); (5) positive lifestyle change; (6) barriers of engaging in healthy lifestyle behaviors (eg, event influence); (7) learning curve; and (8) monitored data sharing']",['blood glucose levels'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C2713450', 'cui_str': 'Data Sharing'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",,0.018114,"Although there were some barriers, participants were able to identify various individual and external facilitators to adjust to and engage in technology-assisted self-monitoring, and it was concluded that the technology-assisted self-monitoring approach was beneficial, safe, and feasible to use for positive lifestyle change.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Center on Smart and Connected Health Technologies, School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Dennis', 'Affiliation': 'Center on Smart and Connected Health Technologies, School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Shanae Lakel', 'Initials': 'SL', 'LastName': 'Rhodes', 'Affiliation': 'School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Sia', 'Affiliation': 'Center on Smart and Connected Health Technologies, School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Jisook', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': 'School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Rozmin', 'Initials': 'R', 'LastName': 'Jiwani', 'Affiliation': 'School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center on Smart and Connected Health Technologies, School of Nursing, University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}]",JMIR diabetes,['10.2196/21183']
1837,32858229,A multi-modal virtual reality treadmill intervention for enhancing mobility and cognitive function in people with multiple sclerosis: Protocol for a randomized controlled trial.,"BACKGROUND


Gait and cognitive impairments are common in individuals with Multiple Sclerosis (MS) and can interfere with everyday function. Those with MS have difficulties executing cognitive tasks and walking simultaneously, a reflection of dual-task interference. Therefore, dual-task training may improve functional ambulation. Additionally, using technology such as virtual reality can provide personalized rehabilitation while mimicking real-world environments. The purpose of this randomized controlled trial is to establish the benefits of a combined cognitive-motor virtual reality training on MS symptoms compared to conventional treadmill training.
METHODS


This study will be a single-blinded, two arm RCT with a six-week intervention period. 144 people with MS will be randomized into a treadmill training alone group or treadmill training with virtual reality group. Both groups will receive 18 sessions of training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system. Primary outcome measures include dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training.
DISCUSSION


This study will provide insight into the ability of a multi-modal cognitive-motor intervention to reduce dual-task cost and to enhance information processing speed in those with MS. This is one of the first studies that is powered to understand whether targeted dual-task training can improve MS symptoms and increase functional ambulation. We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.",2020,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"['people with multiple sclerosis', '144 people with MS', 'individuals with Multiple Sclerosis (MS']","['conventional treadmill training', 'combined cognitive-motor virtual reality training', 'modal virtual reality treadmill intervention', 'treadmill training alone group or treadmill training with virtual reality group', 'dual-task training', 'training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system']","['dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training', 'mobility and cognitive function', 'functional ambulation', 'dual-task gait speed and information processing speed', 'MS symptoms and increase functional ambulation', 'MS symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0376392', 'cui_str': 'Virtual Systems'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",144.0,0.0521126,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirelman', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shema-Shiratzky', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Galperin', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Regev', 'Affiliation': 'Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schmitz-Hübsch', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karni', 'Affiliation': 'Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany; Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Devos', 'Affiliation': 'Laboratory for Advanced Rehabilitation Research in Simulation, Department of Physical Therapy and Rehabilitation Science, School of Health Professions, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sosnoff', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': ""Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Rush Alzheimer's Disease Center and Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA. Electronic address: jhausdor@tlvmc.gov.il.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106122']
1838,32858239,Polyvalent Mechanical Bacterial Lysate Administration Improves the Clinical Course of Grass Pollen-Induced Allergic Rhinitis in Children: A Randomized Controlled Trial.,"BACKGROUND


Recent studies highlight the immunoregulatory potential of bacterial lysates, indicating their potential use in the prevention and treatment of allergic diseases.
OBJECTIVE


To investigate the clinical efficacy of polyvalent mechanical bacterial lysates (PMBLs) in children with grass pollen-induced allergic rhinitis.
METHODS


Seventy children with seasonal allergic rhinitis were enrolled to this study and were randomly assigned to the PMBL and placebo groups. Severity of seasonal allergic rhinitis symptoms was assessed by the total nasal symptom score, total ocular symptom score, and visual analogue scale. During 3 visits, peak nasal inspiratory flow was measured, and nasal smears for the presence of eosinophils and nasal lavage fluids for the presence of allergen-specific IgE against timothy grass pollen allergens were sampled.
RESULTS


A statistically significant decrease in total nasal symptom score (P = .001), total ocular symptom score (P = .04), and visual analogue scale score for nasal and eye symptoms (P < .001 and P < .001, respectively) and an increase in peak nasal inspiratory flow (P = .04) were observed in the PMBL group versus the placebo group. During the grass pollen season, an increase and then a decrease in the number of eosinophils in nasal smears was observed in both groups; however, the number of eosinophils was significantly lower in the PMBL group versus the placebo group. No significant changes in allergen-specific IgE concentrations were observed in the PMBL group, whereas in the placebo group a statistically significant increase in allergen-specific IgE concentration was observed.
CONCLUSIONS


Sublingual administration of PMBLs during the grass pollen season offers significant efficacy in alleviating seasonal allergic rhinitis symptoms in children sensitized to grass pollen allergens. PMBLs probably affect mucosal immunity, weakening the response of T H 2 cells.",2020,"RESULTS


A statistically significant decrease of TNSS (p=0.001), TOSS (p=0.04), VAS for nasal and eye symptoms (p<0.001, p<0.001, respectively) and increase of PNIF (p=0.04) were observed in the PMBL group vs. placebo group.","['children sensitized to grass pollen allergens', 'grass pollen-induced allergic rhinitis in children', 'children with grass pollen-induced allergic rhinitis', 'Seventy children with seasonal allergic rhinitis (SAR']","['PMBL', 'Polyvalent mechanical bacterial lysate administration', 'polyvalent mechanical bacterial lysates (PMBL', 'placebo', 'PMBL and placebo']","['number of eosinophils in nasal smears', 'peak nasal inspiratory flow (PNIF', 'Severity of SAR symptoms', 'asIgE concentration', 'number of eosinophils', 'TOSS', 'TNSS', 'SAR symptoms', 'asIgE concentrations', 'total nasal symptom score (TNSS), total ocular symptom score (TOSS) and visual analogue scale (VAS', 'PNIF', 'VAS for nasal and eye symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444971', 'cui_str': 'Grass pollen allergen'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}]","[{'cui': 'C1569170', 'cui_str': 'polyvalent mechanical bacterial lysate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0586406', 'cui_str': 'Eye symptom'}]",70.0,0.280302,"RESULTS


A statistically significant decrease of TNSS (p=0.001), TOSS (p=0.04), VAS for nasal and eye symptoms (p<0.001, p<0.001, respectively) and increase of PNIF (p=0.04) were observed in the PMBL group vs. placebo group.","[{'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Janeczek', 'Affiliation': 'Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, Lublin, Poland. Electronic address: kamil.janeczek@umlub.pl.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Emeryk', 'Affiliation': 'Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rachel', 'Affiliation': 'Chair and Department of Human Physiology and Pathophysiology, University of Rzeszów, Rzeszów, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Duma', 'Affiliation': 'Department of Laboratory Diagnostics, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Zimmer', 'Affiliation': 'Department of Applied and Social Pharmacy, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Poleszak', 'Affiliation': 'Department of Applied and Social Pharmacy, Medical University of Lublin, Lublin, Poland.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.08.025']
1839,32859183,Effects of exercise combined with whole body vibration in patients with patellofemoral pain syndrome: a randomised-controlled clinical trial.,"BACKGROUND


Patellofemoral pain is a prevalent condition in the general population, especially in women, and produces functional impairment in patients. Therapeutic exercise is considered an essential part of the conservative management. The use of vibration platforms may help improve strength and function and reduce pain in patients with knee disorders. The aim of this investigation was to determine the effects of adding whole body vibration (vertical, vibration frequency of 40 Hz, with an amplitude from 2 to 4 mm) to an exercise protocol for pain and disability in adults with patellofemoral pain.
METHODS


A randomised clinical trial was designed, where 50 subjects were randomly distributed into either an exercise group plus whole body vibration or a control group. Pain, knee function (self-reported questionnaire) and range of motion and lower limb functionality were assessed at baseline and at 4 weeks. The experimental group performed 12 supervised sessions of hip, knee and core strengthening exercises on a vibration platform 3 times per week during 4 weeks. The control group followed the same protocol but without vibration stimuli. Differences in outcome measures were explored using an analysis of the variance of 2 repeated measures. Effect sizes were estimated using Square Eta (η 2 ). Significant level was set al P < 0.05.
RESULTS


Statistically significant differences were found after intervention in favour of the experimental group in the between-groups comparison and in the interaction of the experimental group before and after treatment in terms of pain perception (P = 0.000; η 2  = 0.63) and function outcomes scores (P = 0.000; η 2  0.39 and 0.51 for lower limb functional scale and Kujala scores respectively).
CONCLUSION


A 4-week whole body vibration exercise programme reduces pain level intensity and improves lower limb functionality in patellofemoral pain patients and is more effective than exercise alone in improving pain and function in the short-term.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT04031248 ). This study was prospectively registered on the 24th July, 2019.",2020,"Statistically significant differences were found after intervention in favour of the experimental group in the between-groups comparison and in the interaction of the experimental group before and after treatment in terms of pain perception (P = 0.000; η 2  = 0.63) and function outcomes scores (P = 0.000; η 2  0.39 and 0.51 for lower limb functional scale and Kujala scores respectively).
","['adults with patellofemoral pain', 'patellofemoral pain patients', '50 subjects', 'patients with patellofemoral pain syndrome', 'patients with knee disorders']","['Therapeutic exercise', 'vibration platforms', 'exercise group plus whole body vibration or a control group', 'exercise combined with whole body vibration', '12 supervised sessions of hip, knee and core strengthening exercises', 'whole body vibration (vertical, vibration frequency of 40\u2009Hz, with an amplitude from 2 to 4\u2009mm) to an exercise protocol', 'exercise alone', 'body vibration exercise programme']","['function outcomes scores', 'pain and function', 'strength and function and reduce pain', 'pain and disability', 'pain level intensity', 'Pain, knee function (self-reported questionnaire) and range of motion and lower limb functionality', 'pain perception']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",50.0,0.0652986,"Statistically significant differences were found after intervention in favour of the experimental group in the between-groups comparison and in the interaction of the experimental group before and after treatment in terms of pain perception (P = 0.000; η 2  = 0.63) and function outcomes scores (P = 0.000; η 2  0.39 and 0.51 for lower limb functional scale and Kujala scores respectively).
","[{'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Yañez-Álvarez', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, 41009, Seville, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Bermúdez-Pulgarín', 'Affiliation': 'Department of Celular Biology, University of Seville, 41009, Seville, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Hernández-Sánchez', 'Affiliation': ""Physiotherapy Area, Traslational Research Centre of Physiotherapy, Miguel Hernandez University, Sant Joan d'Alacant, 03550, Alicante, Spain. sehesa@goumh.umh.es.""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Albornoz-Cabello', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, 41009, Seville, Spain.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03599-2']
1840,32861271,"A machine-learning algorithm for neonatal seizure recognition: a multicentre, randomised, controlled trial.","BACKGROUND


Despite the availability of continuous conventional electroencephalography (cEEG), accurate diagnosis of neonatal seizures is challenging in clinical practice. Algorithms for decision support in the recognition of neonatal seizures could improve detection. We aimed to assess the diagnostic accuracy of an automated seizure detection algorithm called Algorithm for Neonatal Seizure Recognition (ANSeR).
METHODS


This multicentre, randomised, two-arm, parallel, controlled trial was done in eight neonatal centres across Ireland, the Netherlands, Sweden, and the UK. Neonates with a corrected gestational age between 36 and 44 weeks with, or at significant risk of, seizures requiring EEG monitoring, received cEEG plus ANSeR linked to the EEG monitor displaying a seizure probability trend in real time (algorithm group) or cEEG monitoring alone (non-algorithm group). The primary outcome was diagnostic accuracy (sensitivity, specificity, and false detection rate) of health-care professionals to identify neonates with electrographic seizures and seizure hours with and without the support of the ANSeR algorithm. Neonates with data on the outcome of interest were included in the analysis. This study is registered with ClinicalTrials.gov, NCT02431780.
FINDINGS


Between Feb 13, 2015, and Feb 7, 2017, 132 neonates were randomly assigned to the algorithm group and 132 to the non-algorithm group. Six neonates were excluded (four from the algorithm group and two from the non-algorithm group). Electrographic seizures were present in 32 (25·0%) of 128 neonates in the algorithm group and 38 (29·2%) of 130 neonates in the non-algorithm group. For recognition of neonates with electrographic seizures, sensitivity was 81·3% (95% CI 66·7-93·3) in the algorithm group and 89·5% (78·4-97·5) in the non-algorithm group; specificity was 84·4% (95% CI 76·9-91·0) in the algorithm group and 89·1% (82·5-94·7) in the non-algorithm group; and the false detection rate was 36·6% (95% CI 22·7-52·1) in the algorithm group and 22·7% (11·6-35·9) in the non-algorithm group. We identified 659 h in which seizures occurred (seizure hours): 268 h in the algorithm versus 391 h in the non-algorithm group. The percentage of seizure hours correctly identified was higher in the algorithm group than in the non-algorithm group (177 [66·0%; 95% CI 53·8-77·3] of 268 h vs 177 [45·3%; 34·5-58·3] of 391 h; difference 20·8% [3·6-37·1]). No significant differences were seen in the percentage of neonates with seizures given at least one inappropriate antiseizure medication (37·5% [95% CI 25·0 to 56·3] vs 31·6% [21·1 to 47·4]; difference 5·9% [-14·0 to 26·3]).
INTERPRETATION


ANSeR, a machine-learning algorithm, is safe and able to accurately detect neonatal seizures. Although the algorithm did not enhance identification of individual neonates with seizures beyond conventional EEG, recognition of seizure hours was improved with use of ANSeR. The benefit might be greater in less experienced centres, but further study is required.
FUNDING


Wellcome Trust, Science Foundation Ireland, and Nihon Kohden.",2020,"Although the algorithm did not enhance identification of individual neonates with seizures beyond conventional EEG, recognition of seizure hours was improved with use of ANSeR. The benefit might be greater in less experienced centres, but further study is required.
","['Neonates with a corrected gestational age between 36 and 44 weeks with, or at significant risk of, seizures requiring EEG monitoring, received cEEG plus ANSeR linked to the EEG monitor displaying a seizure probability trend in real time (algorithm group) or', '132 neonates', 'neonatal seizure recognition', 'eight neonatal centres across Ireland, the Netherlands, Sweden, and the UK']","['machine-learning algorithm', 'continuous conventional electroencephalography (cEEG', 'cEEG monitoring alone', 'automated seizure detection algorithm called Algorithm']","['percentage of seizure hours correctly identified', 'false detection rate', 'diagnostic accuracy (sensitivity, specificity, and false detection rate) of health-care professionals to identify neonates with electrographic seizures and seizure hours with and without the support of the ANSeR algorithm', 'Electrographic seizures', 'percentage of neonates with seizures given at least one inappropriate antiseizure medication']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1304879', 'cui_str': 'Electroencephalographic monitoring regime'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",132.0,0.175097,"Although the algorithm did not enhance identification of individual neonates with seizures beyond conventional EEG, recognition of seizure hours was improved with use of ANSeR. The benefit might be greater in less experienced centres, but further study is required.
","[{'ForeName': 'Andreea M', 'Initials': 'AM', 'LastName': 'Pavel', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Rennie', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'de Vries', 'Affiliation': 'Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Blennow', 'Affiliation': 'Department of Neonatal Medicine, Karolinska University Hospital, Stockholm, Sweden; Division of Paediatrics, Department CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Foran', 'Affiliation': 'Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Divyen K', 'Initials': 'DK', 'LastName': 'Shah', 'Affiliation': 'Royal London Hospital, London, UK; London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Ronit M', 'Initials': 'RM', 'LastName': 'Pressler', 'Affiliation': 'Department of Clinical Neurophysiology, Great Ormond Street Hospital for Children NHS Trust, London, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kapellou', 'Affiliation': 'Homerton University Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Eugene M', 'Initials': 'EM', 'LastName': 'Dempsey', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Mathieson', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pavlidis', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'van Huffelen', 'Affiliation': 'Clinical Neurophysiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Livingstone', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Mona C', 'Initials': 'MC', 'LastName': 'Toet', 'Affiliation': 'Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Weeke', 'Affiliation': 'Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Finder', 'Affiliation': 'Department of Neonatal Medicine, Karolinska University Hospital, Stockholm, Sweden; Division of Paediatrics, Department CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Subhabrata', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': ""Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Deirdre M', 'Initials': 'DM', 'LastName': 'Murray', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Marnane', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland.'}, {'ForeName': 'Geraldine B', 'Initials': 'GB', 'LastName': 'Boylan', 'Affiliation': 'INFANT Research Centre, University College Cork, Cork, Ireland; Department of Paediatrics and Child Health, University College Cork, Cork, Ireland. Electronic address: g.boylan@ucc.ie.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30239-X']
1841,32866148,The effects of a 6-week core exercises on swimming performance of national level swimmers.,"The aim of this study was to assess the impact of a 6-week specialized training program aimed at strengthening core muscles to improve the effectiveness of selected elements of a swimming race on a group of Polish swimmers. Sixteen male national level swimmers (21.6 ± 2.2 years) participated in the research. The competitors were randomly assigned to 1 of 2 groups before the data collection process: an experimental (EG, n = 8) and a control (CG, n = 8) group. Both groups of swimmers underwent the same training program in the water environment (volume and intensity), while swimmers from the EG additionally performed specific core muscle training. The task of the swimmers was an individual front crawl swim of 50 m, during which the kinematic parameters of the start jump, turn and swimming techniques were recorded using a video camera system. In both groups, a minor increase in the flight phase was observed at the start (EG = 0.06 m, 1.8%; p = 0.088; CG = 0.08 m, 2.7%; p = 0.013). The time to cover a distance of 5 m after the turn and the recorded average speed in swimming this distance for the EG statistically significantly improved by 0.1 s (-28.6%; p < 0.001) and 3.56 m∙s-1 (23.2%; p = 0.001), respectively. In the EG, a statistically significant improvement in 50 m front crawl swimming performance of 0.3 s (-1.2%, p = 0.001) was observed. The results of the research show that the implementation of isolated strengthening of the stabilizing muscles seems to be a valuable addition to the standard training of swimmers.",2020,"In both groups, a minor increase in the flight phase was observed at the start (EG = 0.06 m, 1.8%; p = 0.088; CG = 0.08 m, 2.7%; p = 0.013).","['national level swimmers', 'Sixteen male national level swimmers (21.6 ± 2.2 years) participated in the research']","['6-week core exercises', 'same training program in the water environment (volume and intensity), while swimmers from the EG additionally performed specific core muscle training', 'specialized training program']","['flight phase', '50 m front crawl swimming performance']","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0235042', 'cui_str': 'Does crawl'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}]",16.0,0.0176409,"In both groups, a minor increase in the flight phase was observed at the start (EG = 0.06 m, 1.8%; p = 0.088; CG = 0.08 m, 2.7%; p = 0.013).","[{'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Karpiński', 'Affiliation': 'Institute of Sport Science, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Rejdych', 'Affiliation': 'Institute of Sport Science, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Brzozowska', 'Affiliation': 'Institute of Sport Science, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Gołaś', 'Affiliation': 'Institute of Sport Science, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Sadowski', 'Affiliation': 'Institute of Sport Science, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Andrzej Szymon', 'Initials': 'AS', 'LastName': 'Swinarew', 'Affiliation': 'Faculty of Science and Technology, University of Silesia in Katowice, Katowice, Poland.'}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Stachura', 'Affiliation': 'Institute of Sport Science, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Subir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Faculty of Medical Sciences, University of West Indies, Cave Hill, Wanstead, Barbados.'}, {'ForeName': 'Arkadiusz', 'Initials': 'A', 'LastName': 'Stanula', 'Affiliation': 'Institute of Sport Science, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}]",PloS one,['10.1371/journal.pone.0227394']
1842,32866151,Effects of calf muscle conditioning upon ankle proprioception.,"Ankle proprioception is crucial for balance and relies upon accurate input from calf muscle spindles. Spindle input, in turn, depends upon the physiological and mechanical properties of surrounding muscle tissue. Altering these properties could affect ankle proprioception, with potential consequences for balance. Here we determine the effects of prior muscle cooling, stretch and contraction upon performance of a contralateral ankle joint matching task. Participants stood passively leaning against a board oriented 22° rearward from vertical. Their right ankle was rotated to a randomised position between ± 6° plantar/dorsiflexion. The task was to align the left ankle to the same position, without vision. In the first experiment, immediately prior to each testing session, participants either produced a strong calf muscle contraction in a fully plantarflexed (tiptoe) posture or underwent 15° dorsiflexion stretch. Contraction had no effect on task performance, whereas stretch produced a significant bias in ankle placement of 0.89 ± 0.6°, indicating that participants perceived their foot to be more plantarflexed compared to a control condition. In the second experiment, the right lower leg was cooled in iced water (≤ 5°C) for 10 minutes. Cooling increased joint matching error by ~0.4°, through a combination of increased bias and variability. These results confirm that conditioning the triceps surae muscles can alter perception of ankle joint position. Since body movement during quiet stance is in the order of 1°, the magnitude of these changes are relevant for balance.",2020,"Contraction had no effect on task performance, whereas stretch produced a significant bias in ankle placement of 0.89 ± 0.6°, indicating that participants perceived their foot to be more plantarflexed compared to a control condition.",['Participants stood passively leaning against a board oriented 22° rearward from vertical'],"['strong calf muscle contraction in a fully plantarflexed (tiptoe) posture or underwent 15° dorsiflexion stretch', 'calf muscle conditioning']","['joint matching error', 'ankle proprioception', 'task performance']","[{'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}]","[{'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.0281782,"Contraction had no effect on task performance, whereas stretch produced a significant bias in ankle placement of 0.89 ± 0.6°, indicating that participants perceived their foot to be more plantarflexed compared to a control condition.","[{'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Reynolds', 'Affiliation': 'The School of Sport, Exercise & Rehabilitation Sciences, The University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Craig P', 'Initials': 'CP', 'LastName': 'Smith', 'Affiliation': 'The School of Sport, Exercise & Rehabilitation Sciences, The University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Rufei', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'The School of Sport, Exercise & Rehabilitation Sciences, The University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Griffin', 'Affiliation': 'The School of Sport, Exercise & Rehabilitation Sciences, The University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Dunn', 'Affiliation': 'The School of Sport, Exercise & Rehabilitation Sciences, The University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'McAllister', 'Affiliation': 'The School of Sport, Exercise & Rehabilitation Sciences, The University of Birmingham, Birmingham, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0236731']
1843,32869813,In vitro  gastric emptying characteristics of konjac glucomannan with different viscosity and its effects on appetite regulation.,"Konjac glucomannan (KGM) is associated with the satiety-enhancing property by imparting the food matrix with high viscosity. In the present study, rheology tests on KGM sol with different viscosities were conducted to understand its flow behavior as they presented in the mouth and stomach, and the in vitro gastric emptying characteristics of KGM were examined with a human gastric simulator. Then, their effects on subjective appetite, glycemia, and appetite-related hormones (insulin, GLP-1, PYY3-36, CCK-8, ghrelin) response were investigated by conducting a randomized, single-blind, crossover trial in 22 healthy adults (11 female and 11 male, mean age (years): 23.2 ± 2.0, BMI (kg m-2): 20.6 ± 2.1). The blood samples and ratings for subjective appetite were collected at regular time intervals after the subjects were fed with four test breakfasts (one control treatment and three experimental treatments) on four different days. An ad libitum lunch was provided to the subjects once they consumed the breakfasts and their food intake was recorded. As the viscosity increased, the gastric emptying rate was delayed despite a large part of the chyme viscosity lost during digestion. The satiating capacity of the test breakfast was significantly enhanced as its viscosity increased, the and subjects' sensation for hunger, fullness, desire-to-eat, and prospective food consumption differed significantly (p = 0.006, 0.000, 0.002, and 0.001, respectively) between the treatments. The secretion of glycemia and satiety-related hormones were beneficially modulated by the increased viscosity of the test meal but a small decrease in the ad libitum food intake was observed after the intervention of the viscous test breakfasts. Overall, elevating the meal viscosity moderately by using KGM could contribute to combating the challenge of hunger for people in the bodyweight management.",2020,The secretion of glycemia and satiety-related hormones were beneficially modulated by the increased viscosity of the test meal but a small decrease in the ad libitum food intake was observed after the intervention of the viscous test breakfasts.,"['22 healthy adults (11 female and 11 male, mean age (years): 23.2 ± 2.0, BMI (kg m-2): 20.6 ± 2.1']","['KGM', 'Konjac glucomannan (KGM']","[""subjects' sensation for hunger, fullness, desire-to-eat, and prospective food consumption"", 'secretion of glycemia and satiety-related hormones', 'viscosity', 'subjective appetite, glycemia, and appetite-related hormones (insulin, GLP-1, PYY3-36, CCK-8, ghrelin) response', 'gastric emptying rate', 'blood samples and ratings for subjective appetite', 'appetite regulation']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C4068876', 'cui_str': '2.1'}]","[{'cui': 'C0043572', 'cui_str': 'glucomannan'}]","[{'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070359', 'cui_str': 'peptide YY (3-36)'}, {'cui': 'C0037167', 'cui_str': 'Sincalide'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003622', 'cui_str': 'Appetite control'}]",22.0,0.0271347,The secretion of glycemia and satiety-related hormones were beneficially modulated by the increased viscosity of the test meal but a small decrease in the ad libitum food intake was observed after the intervention of the viscous test breakfasts.,"[{'ForeName': 'Longchen', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'College of Food Science and Technology, Huazhong Agricultural University, Wuhan 430070, China. libinfood@mail.hzau.edu.cn and Key Laboratory of Environment Correlative Dietology, Huazhong Agricultural University, Ministry of Education, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'College of Food Science and Technology, Huazhong Agricultural University, Wuhan 430070, China. libinfood@mail.hzau.edu.cn and Key Laboratory of Environment Correlative Dietology, Huazhong Agricultural University, Ministry of Education, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'College of Food Science and Technology, Huazhong Agricultural University, Wuhan 430070, China. libinfood@mail.hzau.edu.cn and Key Laboratory of Environment Correlative Dietology, Huazhong Agricultural University, Ministry of Education, China.'}, {'ForeName': 'Tingyang', 'Initials': 'T', 'LastName': 'Ai', 'Affiliation': 'College of Food Science and Technology, Huazhong Agricultural University, Wuhan 430070, China. libinfood@mail.hzau.edu.cn and Key Laboratory of Environment Correlative Dietology, Huazhong Agricultural University, Ministry of Education, China.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'College of Food Science and Technology, Huazhong Agricultural University, Wuhan 430070, China. libinfood@mail.hzau.edu.cn and Key Laboratory of Environment Correlative Dietology, Huazhong Agricultural University, Ministry of Education, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'College of Food Science and Technology, Huazhong Agricultural University, Wuhan 430070, China. libinfood@mail.hzau.edu.cn and Key Laboratory of Environment Correlative Dietology, Huazhong Agricultural University, Ministry of Education, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'College of Food Science and Technology, Huazhong Agricultural University, Wuhan 430070, China. libinfood@mail.hzau.edu.cn and Key Laboratory of Environment Correlative Dietology, Huazhong Agricultural University, Ministry of Education, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'College of Food Science and Technology, Huazhong Agricultural University, Wuhan 430070, China. libinfood@mail.hzau.edu.cn and Key Laboratory of Environment Correlative Dietology, Huazhong Agricultural University, Ministry of Education, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'College of Food Science and Technology, Huazhong Agricultural University, Wuhan 430070, China. libinfood@mail.hzau.edu.cn and Key Laboratory of Environment Correlative Dietology, Huazhong Agricultural University, Ministry of Education, China.'}]",Food & function,['10.1039/d0fo01104e']
1844,32870583,Central encoding of the strength of intranasal chemosensory trigeminal stimuli in a human experimental pain setting.,"An important measure in pain research is the intensity of nociceptive stimuli and their cortical representation. However, there is evidence of different cerebral representations of nociceptive stimuli, including the fact that cortical areas recruited during processing of intranasal nociceptive chemical stimuli included those outside the traditional trigeminal areas. Therefore, the aim of this study was to investigate the major cerebral representations of stimulus intensity associated with intranasal chemical trigeminal stimulation. Trigeminal stimulation was achieved with carbon dioxide presented to the nasal mucosa. Using a single-blinded, randomized crossover design, 24 subjects received nociceptive stimuli with two different stimulation paradigms, depending on the just noticeable differences in the stimulus strengths applied. Stimulus-related brain activations were recorded using functional magnetic resonance imaging with event-related design. Brain activations increased significantly with increasing stimulus intensity, with the largest cluster at the right Rolandic operculum and a global maximum in a smaller cluster at the left lower frontal orbital lobe. Region of interest analyses additionally supported an activation pattern correlated with the stimulus intensity at the piriform cortex as an area of special interest with the trigeminal input. The results support the piriform cortex, in addition to the secondary somatosensory cortex, as a major area of interest for stimulus strength-related brain activation in pain models using trigeminal stimuli. This makes both areas a primary objective to be observed in human experimental pain settings where trigeminal input is used to study effects of analgesics.",2020,"Brain activations increased significantly with increasing stimulus intensity, with the largest cluster at the right Rolandic operculum and a global maximum in a smaller cluster at the left lower frontal orbital lobe.",['24 subjects received'],"['intranasal chemical trigeminal stimulation', 'nociceptive stimuli', 'carbon dioxide']","['Brain activations', 'Stimulus-related brain activations']",[],"[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",24.0,0.0402107,"Brain activations increased significantly with increasing stimulus intensity, with the largest cluster at the right Rolandic operculum and a global maximum in a smaller cluster at the left lower frontal orbital lobe.","[{'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Lötsch', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe - University, Frankfurt am Main, Germany.'}, {'ForeName': 'Bruno G', 'Initials': 'BG', 'LastName': 'Oertel', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe - University, Frankfurt am Main, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Felden', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe - University, Frankfurt am Main, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Nöth', 'Affiliation': 'Brain Imaging Center, Goethe - University, Frankfurt am Main, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Deichmann', 'Affiliation': 'Brain Imaging Center, Goethe - University, Frankfurt am Main, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Walter', 'Affiliation': 'Institute of Clinical Pharmacology, Goethe - University, Frankfurt am Main, Germany.'}]",Human brain mapping,['10.1002/hbm.25190']
1845,32870957,Effects of Acute Experimental Stress on Pain Sensitivity and Cortisol Levels in Healthy Participants: A Randomized Crossover Pilot Study.,"AIMS


To investigate pain sensitivity in the masseter muscle and index finger in response to acute psychologic stress in healthy participants.
METHODS


Fifteen healthy women (23.7 ± 2.3 years) participated in two randomized sessions: in the experimental stress session, the Paced Auditory Serial Addition Task (PASAT) was used to induce acute stress, and in the control session, a control task was performed. Salivary cortisol, perceived stress levels, electrical and pressure pain thresholds (PTs), and pain tolerance levels (PTLs) were measured at baseline and after each task. Mixed-model analysis was used to test for significant interaction effects between time and session.
RESULTS


An interaction effect between time and session occurred for perceived stress levels (P < .001); perceived stress was significantly higher after the experimental task than after the control task (P < .01). No interaction effects occurred for salivary cortisol levels, electrical PTs, or pressure PTLs. Although significant interactions did occur for electrical PTL (P < .05) and pressure PT (P < .001), the simple effects test could not identify significant differences between sessions at any time point.
CONCLUSION


The PASAT evoked significant levels of perceived stress; however, pain sensitivity to mechanical or electrical stimuli was not significantly altered in response to the stress task, and the salivary cortisol levels were not altered in response to the PASAT. These results must be interpreted with caution, and more studies with larger study samples are needed to increase the clinical relevant understanding of the pain mechanisms and psychologic stress.",2020,"The PASAT evoked significant levels of perceived stress; however, pain sensitivity to mechanical or electrical stimuli was not significantly altered in response to the stress task, and the salivary cortisol levels were not altered in response to the PASAT.","['Fifteen healthy women (23.7 ± 2.3 years', 'healthy participants', 'Healthy Participants']","['experimental stress session, the Paced Auditory Serial Addition Task (PASAT']","['Salivary cortisol, perceived stress levels, electrical and pressure pain thresholds (PTs), and pain tolerance levels (PTLs', 'stress levels', 'salivary cortisol levels', 'Pain Sensitivity and Cortisol Levels', 'salivary cortisol levels, electrical PTs, or pressure PTLs', 'pressure PT', 'pain sensitivity to mechanical or electrical stimuli', 'electrical PTL', 'pain sensitivity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",15.0,0.0366516,"The PASAT evoked significant levels of perceived stress; however, pain sensitivity to mechanical or electrical stimuli was not significantly altered in response to the stress task, and the salivary cortisol levels were not altered in response to the PASAT.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Dawson', 'Affiliation': ''}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Bendixen', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': ''}, {'ForeName': 'Tuan', 'Initials': 'T', 'LastName': 'van Bui', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'List', 'Affiliation': ''}]",Journal of oral & facial pain and headache,['10.11607/ofph.2488']
1846,32871021,Complementary and alternative therapies for post-caesarean pain.,"BACKGROUND


Pain after caesarean sections (CS) can affect the well-being of the mother and her ability with her newborn. Conventional pain-relieving strategies are often underused because of concerns about the adverse maternal and neonatal effects. Complementary alternative therapies (CAM) may offer an alternative for post-CS pain.
OBJECTIVES


To assess the effects of CAM for post-caesarean pain.
SEARCH METHODS


We searched Cochrane Pregnancy and Childbirth's Trials Register, LILACS, PEDro, CAMbase, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (6 September 2019), and checked the reference lists of retrieved articles.
SELECTION CRITERIA


Randomised controlled trials (RCTs), including quasi-RCTs and cluster-RCTs, comparing CAM, alone or associated with other forms of pain relief, versus other treatments or placebo or no treatment, for the treatment of post-CS pain.
DATA COLLECTION AND ANALYSIS


Two review authors independently performed study selection, extracted data, assessed risk of bias and assessed the certainty of evidence using GRADE.
MAIN RESULTS


We included 37 studies (3076 women) which investigated eight different CAM therapies for post-CS pain relief. There is substantial heterogeneity among the trials. We downgraded the certainty of evidence due to small numbers of women participating in the trials and to risk of bias related to lack of blinding and inadequate reporting of randomisation processes. None of the trials reported pain at six weeks after discharge. Primary outcomes were pain and adverse effects, reported per intervention below. Secondary outcomes included vital signs, rescue analgesic requirement at six weeks after discharge; all of which were poorly reported, not reported, or we are uncertain as to the effect Acupuncture or acupressure We are very uncertain if acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus placebo plus analgesia) has any effect on pain because the quality of evidence is very low. Acupuncture or acupressure plus analgesia (versus analgesia) may reduce pain at 12 hours (standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.64 to 0.07; 130 women; 2 studies; low-certainty evidence) and 24 hours (SMD -0.63, 95% CI -0.99 to -0.26; 2 studies; 130 women; low-certainty evidence). It is uncertain whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus analgesia) has any effect on the risk of adverse effects because the quality of evidence is very low. Aromatherapy Aromatherapy plus analgesia may reduce pain when compared with placebo plus analgesia at 12 hours (mean difference (MD) -2.63 visual analogue scale (VAS), 95% CI -3.48 to -1.77; 3 studies; 360 women; low-certainty evidence) and 24 hours (MD -3.38 VAS, 95% CI -3.85 to -2.91; 1 study; 200 women; low-certainty evidence). We are uncertain if aromatherapy plus analgesia has any effect on adverse effects (anxiety) compared with placebo plus analgesia. Electromagnetic therapy Electromagnetic therapy may reduce pain compared with placebo plus analgesia at 12 hours (MD -8.00, 95% CI -11.65 to -4.35; 1 study; 72 women; low-certainty evidence) and 24 hours (MD -13.00 VAS, 95% CI -17.13 to -8.87; 1 study; 72 women; low-certainty evidence). Massage We identified six studies (651 women), five of which were quasi-RCTs, comparing massage (foot and hand) plus analgesia versus analgesia. All the evidence relating to pain, adverse effects (anxiety), vital signs and rescue analgesic requirement was very low-certainty. Music Music plus analgesia may reduce pain when compared with placebo plus analgesia at one hour (SMD -0.84, 95% CI -1.23 to -0.46; participants = 115; studies = 2; I 2  = 0%; low-certainty evidence), 24 hours (MD -1.79, 95% CI -2.67 to -0.91; 1 study; 38 women; low-certainty evidence), and also when compared with analgesia at one hour (MD -2.11, 95% CI -3.11 to -1.10; 1 study; 38 women; low-certainty evidence) and at 24 hours (MD -2.69, 95% CI -3.67 to -1.70; 1 study; 38 women; low-certainty evidence). It is uncertain whether music plus analgesia has any effect on adverse effects (anxiety), when compared with placebo plus analgesia because the quality of evidence is very low. Reiki We are uncertain if Reiki plus analgesia compared with analgesia alone has any effect on pain, adverse effects, vital signs or rescue analgesic requirement because the quality of evidence is very low (one study, 90 women). Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence). Transcutaneous electrical nerve stimulation TENS (versus no treatment) may reduce pain at one hour (MD -2.26, 95% CI -3.35 to -1.17; 1 study; 40 women; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce pain compared with placebo plus analgesia at one hour (SMD -1.10 VAS, 95% CI -1.37 to -0.82; 3 studies; 238 women; low-certainty evidence) and at 24 hours (MD -0.70 VAS, 95% CI -0.87 to -0.53; 108 women; 1 study; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce heart rate (MD -7.00 bpm, 95% CI -7.63 to -6.37; 108 women; 1 study; low-certainty evidence) and respiratory rate (MD -1.10 brpm, 95% CI -1.26 to -0.94; 108 women; 1 study; low-certainty evidence). We are uncertain if TENS plus analgesia (versus analgesia) has any effect on pain at six hours or 24 hours, or vital signs because the quality of evidence is very low (two studies, 92 women).
AUTHORS' CONCLUSIONS


Some CAM therapies may help reduce post-CS pain for up to 24 hours. The evidence on adverse events is too uncertain to make any judgements on safety and we have no evidence about the longer-term effects on pain. Since pain control is the most relevant outcome for post-CS women and their clinicians, it is important that future studies of CAM for post-CS pain measure pain as a primary outcome, preferably as the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. Measuring pain as a dichotomous variable would improve the certainty of evidence and it is easy to understand for non-specialists. Future trials also need to be large enough to detect effects on clinical outcomes; measure other important outcomes as listed lin this review, and use validated scales.",2020,"Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence).","['37 studies (3076 women) which investigated eight different CAM therapies for post-CS pain relief', 'post-caesarean pain']","['Complementary alternative therapies (CAM', 'CAM', 'placebo plus analgesia', 'acupuncture or acupressure plus analgesia (versus placebo plus analgesia', 'TENS plus analgesia (versus placebo plus analgesia', 'massage (foot and hand) plus analgesia versus analgesia', 'acupressure', 'acupuncture or acupressure', 'acupuncture or acupressure plus analgesia', 'Transcutaneous electrical nerve stimulation TENS', 'Aromatherapy Aromatherapy plus analgesia', 'Electromagnetic therapy Electromagnetic therapy', 'placebo', 'Acupuncture or acupressure plus analgesia (versus analgesia', 'Relaxation Relaxation']","['respiratory rate', 'vital signs, rescue analgesic requirement', 'pain and adverse effects', 'adverse effects (anxiety', 'pain relief', 'pain, adverse effects (anxiety), vital signs and rescue analgesic requirement', 'heart rate', 'post-CS pain', 'pain']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C2729328', 'cui_str': 'Electromagnetic therapy'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",90.0,0.675575,"Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence).","[{'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Zimpel', 'Affiliation': 'Alagoas State University of Health Sciences, Maceió, Brazil.'}, {'ForeName': 'Maria Regina', 'Initials': 'MR', 'LastName': 'Torloni', 'Affiliation': 'Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, São Paulo, Brazil.'}, {'ForeName': 'Gustavo Jm', 'Initials': 'GJ', 'LastName': 'Porfírio', 'Affiliation': 'Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, São Paulo, Brazil.'}, {'ForeName': 'Ronald Lg', 'Initials': 'RL', 'LastName': 'Flumignan', 'Affiliation': 'Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edina Mk', 'Initials': 'EM', 'LastName': 'da Silva', 'Affiliation': 'Emergency Medicine and Evidence Based Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD011216.pub2']
1847,32881123,Peri-implant defect grafting with autogenous bone or bone graft material in immediate implant placement in molar extraction sites-1- to 3-year results of a prospective randomized study.,"OBJECTIVES


To evaluate the survival rate, the orobuccal bone resorption and stability of peri-implant hard and soft tissues following immediate implant placement of wide diameter implants in molar extraction sites and peri-implant defect grafting with autogenous bone (AB) or biphasic bone graft material (BBGM) with 1- to 3-year follow-up examinations.
MATERIAL AND METHODS


Fifty wide diameter implants were placed in 50 patients immediately into molar extraction sockets by a flapless approach. Peri-implant defect augmentation was performed randomized with either AB or BBGM. Primary outcome variable was implant survival. Marginal bone level changes, orobuccal width of the alveolar crest, probing depths, and implant success were considered as secondary parameters.
RESULTS


One implant of the BBGM group was lost, 1 patient withdrew from the study (drop-out). The remaining 48 patients were still in function at a follow-up period up to 31 months after implant insertion. Interproximal marginal bone level regenerated from -7.5 mm to the level of the implant shoulder (AB + 0.38 mm, BBGM + 0.1 mm) at final follow-up. The width of the alveolar crest changed by -0.08 mm (AB) and +0.72 mm (BBGM) at 1 mm, -0.36 mm (AB) and +0.27 mm (BBGM) at 3 mm, -0.36 mm (AB) and +0.31 mm (BBGM) at 6 mm apical to implant shoulder level. Success rate was 87.5% in the AB and 56.3% in the BBGM group (p = .058).
CONCLUSIONS


Medium-term results prove a high survival rate, a favorable amount of bone generation in both groups and a low amount of orobuccal resorption in immediate molar implant insertion.",2020,"Success rate was 87.5% in the AB and 56.3% in the BBGM group (p=0.058).
","['Fifty wide diameter implants were placed in 50 patients immediately into molar extraction sockets by a flapless approach', 'Molar Extraction Sites']","['Periimplant Defect Grafting with Autogenous Bone or Bone Graft Material', 'AB or BBGM', 'autogenous bone (AB) or biphasic bone graft material (BBGM', 'BBGM']","['Interproximal marginal bone level', 'Marginal bone level changes, orobuccal width of the alveolar crest, probing depths and implant success', 'width of the alveolar crest', 'Success rate', 'survival rate', 'implant survival']","[{'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",50.0,0.13162,"Success rate was 87.5% in the AB and 56.3% in the BBGM group (p=0.058).
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Noelken', 'Affiliation': 'Private Practice for Oral Surgery, Lindau/Lake Constance, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Pausch', 'Affiliation': 'Private Practice for Oral Surgery, Weiden in the Upper Palatinate, Weiden, Germany.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Wagner', 'Affiliation': 'Department of Oral and Maxillofacial Surgery - Plastic Surgery, University Medical Center, Johannes Gutenberg University of Mainz, Mainz, Germany.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Al-Nawas', 'Affiliation': 'Department of Oral and Maxillofacial Surgery - Plastic Surgery, University Medical Center, Johannes Gutenberg University of Mainz, Mainz, Germany.'}]",Clinical oral implants research,['10.1111/clr.13660']
1848,32877886,Effects of peripheral and different inspiratory muscle training methods in coronary artery disease patients with metabolic syndrome: A randomized-controlled trial.,"Background OBJECTIVE: To investigate the effects of peripheral muscle training (PMT) and different inspiratory muscle training (IMT) methods on respiratory functions, exercise capacity, and biochemistry parameters in coronary artery disease patients with metabolic syndrome.
METHODS


This prospective, single-blind, randomized-controlled study included 60 patients of stable coronary artery disease with metabolic syndrome (New York Heart Association [NYHA] Class I-II, left ventricular ejection fraction >40%). Patients were randomly divided into three groups: neuromuscular electrical stimulation (NMES) plus PMT group (NMES + PMT group, n = 20), IMT plus PMT group (IMT + PMT group, n = 20) and PMT group (PMT group, n = 20). Treatment continued for six weeks for all groups. The NMES was applied to rectus abdominis, IMT was applied with 30% of maximal inspiratory pressures, and PMT was applied at home. Spirometry, maximal inspiratory and expiratory pressure, dyspnea scores, exercise stress test, and biochemistry parameters were measured before and after training.
RESULTS


There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05). Significant improvements in C-reactive protein and erythrocyte sedimentation rate were observed in NMES + PMT and IMT + PMT groups (p < 0.05). Among the groups, there was a significant difference in maximal inspiratory pressure (p = 0.02) and erythrocyte sedimentation rate (p = 0.037) in favor of NMES + PMT group (p < 0.05).
CONCLUSION


Our study results showed significant improvements in respiratory functions, exercise capacity, and biochemistry markers in all groups. Different IMT methods can be used in cardiopulmonary rehabilitation to improve exercise intolerance in coronary artery disease patients with metabolic syndrome.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03523026.",2020,"There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05).","['coronary artery disease patients with metabolic syndrome', '60 patients of stable coronary artery disease with metabolic syndrome (New York Heart Association [NYHA']","['peripheral muscle training (PMT) and different inspiratory muscle training (IMT', 'peripheral and different inspiratory muscle training methods', 'neuromuscular electrical stimulation (NMES) plus PMT group (NMES\xa0+\xa0PMT group, n\xa0=\xa020), IMT plus PMT group (IMT\xa0+\xa0PMT group, n\xa0=\xa020) and PMT group (PMT', 'NMES']","['Spirometry, maximal inspiratory and expiratory pressure, dyspnea scores, exercise stress test, and biochemistry parameters', 'exercise intolerance', 'maximal inspiratory pressure', 'respiratory functions, exercise capacity, and biochemistry markers', 'erythrocyte sedimentation rate', 'C-reactive protein and erythrocyte sedimentation rate', 'spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O', 'respiratory functions, exercise capacity, and biochemistry parameters']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424551', 'cui_str': 'Impaired exercise tolerance'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0003436', 'cui_str': 'Antistreptolysin O'}]",60.0,0.028139,"There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05).","[{'ForeName': 'Kıymet', 'Initials': 'K', 'LastName': 'Muammer', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Mutluay', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Medipol University, Istanbul, Turkey. Electronic address: fmutluay@medipol.edu.tr.'}, {'ForeName': 'Rengin', 'Initials': 'R', 'LastName': 'Demir', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Alev Arat', 'Initials': 'AA', 'LastName': 'Özkan', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106119']
1849,32877981,Bone changes and curative effect of infliximab in patients with ankylosing spondylitis.,"OBJECTIVES


To study the bone changes and curative effect of infliximab in patients with ankylosing spondylitis (AS).
METHODS


AS patients diagnosed and treated in Wuwei People's Hospital from January 2017 to March 2018 were collected as the study subjects of this study, and the patients were divided into INF group (n=40) and MTX group (n=40) according to the random number table. The expression levels of TNF-α and IL-33 before and after treatment were detected by enzyme-linked immunosorbent assay (ELISA), and bone changes before and after treatment were compared between the two groups. The ROC curves of TNF-α and IL-33 for efficacy prediction of AS were drawn and analyzed.
RESULTS


After treatment, the expression levels of serum TNF-α and IL-33 in patients in INF group were significantly lower than those in MTX group (P<0.001), and the improvement of bone erosion and tendon thickening in INF group was markedly higher than that in MTX group (P<0.001). The receiver operating characteristic (ROC) curve revealed that the area under the curve (AUC) of TNF-α for predicting efficacy was 0.939, and that of IL-33 was 0.853.
CONCLUSIONS


Infliximab can significantly improve the bone status and has a positive effect in patients with AS, and TNF-α and IL-33 are expected to be used as efficacy predictors of AS.",2020,"After treatment, the expression levels of serum TNF-α and IL-33 in patients in INF group were significantly lower than those in MTX group (P<0.001), and the improvement of bone erosion and tendon thickening in INF group was markedly higher than that in MTX group (P<0.001).","['patients with ankylosing spondylitis', ""AS patients diagnosed and treated in Wuwei People's Hospital from January 2017 to March 2018 were collected as the study subjects of this study, and the patients were divided into INF group (n=40) and"", 'patients with ankylosing spondylitis (AS']","['infliximab', 'Infliximab', 'MTX']","['expression levels of TNF-α and IL-33', 'bone erosion and tendon thickening', 'expression levels of serum TNF-α and IL-33', 'bone status', 'enzyme-linked immunosorbent assay (ELISA), and bone changes', 'receiver operating characteristic (ROC) curve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1667752', 'cui_str': 'IL33 protein, human'}, {'cui': 'C0587240', 'cui_str': 'Bone erosion'}, {'cui': 'C3854629', 'cui_str': 'Tendon thickening'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0252932,"After treatment, the expression levels of serum TNF-α and IL-33 in patients in INF group were significantly lower than those in MTX group (P<0.001), and the improvement of bone erosion and tendon thickening in INF group was markedly higher than that in MTX group (P<0.001).","[{'ForeName': 'Linying', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Anesthesia Operating Room, Wuwei People's Hospital, Wuwei, P.R. China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Infections Department, Wuwei People's Hospital, Wuwei, P.R. China.""}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopedics, The First Hospital of Lanzhou University, Lanzhou, P.R. China.'}, {'ForeName': 'Gengshen', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, Wuwei People's Hospital, Wuwei, P.R. China.""}]",Journal of musculoskeletal & neuronal interactions,[]
1850,32888454,"Carboplatin plus etoposide versus topotecan as second-line treatment for patients with sensitive relapsed small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trial.","BACKGROUND


Topotecan is currently the only drug approved in Europe in a second-line setting for the treatment of small-cell lung cancer. This study investigated whether the doublet of carboplatin plus etoposide was superior to topotecan as a second-line treatment in patients with sensitive relapsed small-cell lung cancer.
METHODS


In this open-label, randomised, phase 3 trial done in 38 hospitals in France, we enrolled patients with histologically or cytologically confirmed advanced stage IV or locally relapsed small-cell lung cancer, who responded to first-line platinum plus etoposide treatment, but who had disease relapse or progression at least 90 days after completion of first-line treatment. Eligible patients were aged 18 years or older and had an Eastern Cooperative Oncology Group performance status 0-2. Enrolled patients were randomly assigned (1:1) to receive combination carboplatin plus etoposide (six cycles of intravenous carboplatin [area under the curve 5 mg/mL per min] on day 1 plus intravenous etoposide [100 mg/m 2  from day 1 to day 3]) or oral topotecan (2·3 mg/m 2  from day 1 to day 5, for six cycles). Randomisation was done using the minimisation method with biased-coin balancing for ECOG performance status, response to the first-line chemotherapy, and treatment centre. The primary endpoint was progression-free survival, which was centrally reviewed and analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02738346.
FINDINGS


Between July 18, 2013, and July 2, 2018, we enrolled and randomly assigned 164 patients (82 in each study group). One patient from each group withdrew consent, therefore 162 patients (81 in each group) were included in the intention-to-treat population. With a median follow-up of 22·7 months (IQR 20·0-37·3), median progression-free survival was significantly longer in the combination chemotherapy group than in the topotecan group (4·7 months, 90% CI 3·9-5·5 vs 2·7 months, 2·3-3·2; stratified hazard ratio 0·57, 90% CI 0·41-0·73; p=0·0041). The most frequent grade 3-4 adverse events were neutropenia (18 [22%] of 81 patients in the topotecan group vs 11 [14%] of 81 patients in the combination chemotherapy group), thrombocytopenia (29 [36%] vs 25 [31%]), anaemia (17 [21%] vs 20 [25%]), febrile neutropenia (nine [11%] vs five [6%]), and asthenia (eight [10%] vs seven [9%]). Two treatment-related deaths occurred in the topotecan group (both were febrile neutropenia with sepsis) and no treatment-related deaths occurred in the combination group.
INTERPRETATION


Our results suggest that carboplatin plus etoposide rechallenge can be considered as a reasonable second-line chemotherapy option for patients with sensitive relapsed small-cell lung cancer.
FUNDING


Amgen and the French Lung Cancer Group (Groupe Français de Pneumo-Cancérologie).",2020,"Two treatment-related deaths occurred in the topotecan group (both were febrile neutropenia with sepsis) and no treatment-related deaths occurred in the combination group.
","['Between July 18, 2013, and July 2, 2018, we enrolled and randomly assigned 164 patients (82 in each study group', 'patients with sensitive relapsed small-cell lung cancer', '162 patients (81 in each group) were included in the intention-to-treat population', '38 hospitals in France, we enrolled patients with histologically or cytologically confirmed advanced stage IV or locally relapsed small-cell lung cancer, who responded to first-line platinum plus etoposide treatment, but who had disease relapse or progression at least 90 days after completion of first-line treatment', 'Eligible patients were aged 18 years or older and had an Eastern Cooperative Oncology Group performance status 0-2']","['carboplatin plus etoposide', 'oral topotecan', 'Carboplatin plus etoposide versus topotecan', 'combination carboplatin plus etoposide (six cycles of intravenous carboplatin [area under the curve 5 mg/mL per min] on day 1 plus intravenous etoposide']","['febrile neutropenia', 'thrombocytopenia', 'asthenia', 'deaths', 'neutropenia', 'median progression-free survival', 'anaemia', 'progression-free survival', 'febrile neutropenia with sepsis']","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278727', 'cui_str': 'Small cell lung cancer recurrent'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]",164.0,0.170259,"Two treatment-related deaths occurred in the topotecan group (both were febrile neutropenia with sepsis) and no treatment-related deaths occurred in the combination group.
","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Baize', 'Affiliation': ""Service de Cancérologie, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Monnet', 'Affiliation': 'Service de Pneumologie, CHI Créteil, Créteil, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Greillier', 'Affiliation': 'Aix-Marseille University, Marseille, France; Department of Multidisciplinary Oncology and Therapeutic Innovations, APHM, Hôpital Nord, Marseille, France; Department of Multidisciplinary Oncology and Therapeutic Innovations, Hôpital Nord, Marseille, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Geier', 'Affiliation': 'Service de Pneumologie, CHU Brest, Brest, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lena', 'Affiliation': 'Service de Pneumologie, CHU Rennes, Rennes, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Janicot', 'Affiliation': 'Service de Pneumologie, CHU Clermont-Ferrand, Clermont Ferrand, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vergnenegre', 'Affiliation': 'Service de Pneumologie, CHU Limoges, Limoges, France.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Crequit', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Beauvais, Beauvais, France.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Lamy', 'Affiliation': 'Service de Pneumologie, CH Bretagne Sud, Lorient, France.'}, {'ForeName': 'Jean-Bernard', 'Initials': 'JB', 'LastName': 'Auliac', 'Affiliation': 'Service de Pneumologie, CHI Créteil, Créteil, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Letreut', 'Affiliation': 'Service de Pneumologie, Hôpital Européen, Marseille, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Le Caer', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Saint Brieuc, Saint-Brieuc, France.'}, {'ForeName': 'Radj', 'Initials': 'R', 'LastName': 'Gervais', 'Affiliation': ""Service d'Oncologie, Centre François Baclesse, Caen, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dansin', 'Affiliation': ""Service d'Oncologie, Centre Oscar Lambret, Lille, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Madroszyk', 'Affiliation': ""Service d'Oncologie, Institut Paoli-Calmettes, Marseille, France.""}, {'ForeName': 'Patrick-Aldo', 'Initials': 'PA', 'LastName': 'Renault', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Pau, Pau, France.'}, {'ForeName': 'Gwenaëlle', 'Initials': 'G', 'LastName': 'Le Garff', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Saint Brieuc, Saint-Brieuc, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Falchero', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Villefranche de Rouergue, Villefranche, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Berard', 'Affiliation': ""Service de Pneumologie, Hôpital d'instruction des armées Sainte-Anne, Toulon, France.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Schott', 'Affiliation': ""Service d'Oncologie, Centre Paul Strauss, Strasbourg, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Saulnier', 'Affiliation': ""Département de Biostatistiques et Méthodologie, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Chouaid', 'Affiliation': 'Service de Pneumologie, CHI Créteil, Créteil, France; Institut Mondor de Recherche Biomédicale, U955 Inserm-Université Paris Est Créteil, Créteil, France. Electronic address: christos.chouaid@chicreteil.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30461-7']
1851,32889172,Validation of local p16 testing for determination of human papilloma virus status eligibility on a low risk oropharyngeal cancer trial - A Trans-Tasman Radiation Oncology Group study.,"OBJECTIVE


Accurate determination of human papilloma virus (HPV) status is critical when identifying patients with oropharyngeal squamous cell carcinoma (OPSCC) who may be candidates for de-escalation trials. In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
METHODS AND MATERIALS


Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC were randomised based on local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing. Correlations between the local and central p16 and central HPV RNA ISH were studied. The main outcome was the positive predictive value (PPV) of local pathology laboratory testing of p16.
RESULTS


176/182 patients had samples available for central testing. 172/176 were evaluable for central testing of p16, and all were confirmed to be p16 positive (172/172, 100%, 95% CI = [97.9%, 100%]). Similarly, 100% of those evaluable for HPV RNA ISH (155/155, 100%, 95% CI = [97.6%, 100%]) were confirmed HPV positive, indicating p16 overexpression driven by transcriptionally active HPV and a PPV of 100% for local p16 testing.
CONCLUSIONS


Our results validate the suitability of local pathology laboratory p16 testing alone, in populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials. This obviates the need for upfront more complex and expensive HPV assays and/or central laboratory testing.",2020,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","['populations with a high attributable fraction of OPSCC due to HPV, to screen and enrol low risk HPVOPSCC patients onto de-intensification trials', 'patients with oropharyngeal squamous cell carcinoma (OPSCC', 'Patients enrolled on the TROG 12.01 randomised trial for good prognosis HPVOPSCC', '176/182 patients had samples available for central testing']",['local p16 IHC testing but subsequently had central p16 IHC and HPV RNA in situ hybridisation (HPV RNA ISH) testing'],"['positive predictive value (PPV) of local pathology laboratory testing of p16', 'local and central p16 and central HPV RNA ISH', 'HPV RNA ISH']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0020202', 'cui_str': 'Hybridization'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.269323,"In this study we investigated whether local p16 screening, by immunohistochemistry (IHC), has high positive predictive value (PPV) for HPV status in a good prognosis HPV positive OPSCC (HPVOPSCC) population treated on a clinical trial.
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Young', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Solomon', 'Affiliation': 'Research Division, Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Corry', 'Affiliation': ""Genesiscare St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Angel', 'Affiliation': 'Department of Pathology, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Kenny', 'Affiliation': ""Department of Radiation Oncology, Royal Brisbane & Women's Hospital, Brisbane, Australia; Faculty of Medicine, University of Queensland Brisbane, Australia.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Porceddu', 'Affiliation': 'Faculty of Medicine, University of Queensland Brisbane, Australia; Department of Radiation Oncology, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wratten', 'Affiliation': 'Department of Radiation Oncology, Calvary Mater Hospital and University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Macann', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital and University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Jackson', 'Affiliation': 'Radiation Oncology Centres, Gold Coast, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Herschtal', 'Affiliation': 'Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rischin', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia. Electronic address: danny.rischin@petermac.org.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104988']
1852,32889781,Oral contraceptives and menstrual cycle influence autonomic reflex function.,"Progesterone and its analogues are known to influence ventilation. Therefore, the purpose of this study was to investigate the role of endogenous and pharmaceutical female sex hormones in ventilatory control during the activation of the metaboreflex, mechanoreflex, and CO 2  chemoreflex. Women aged 18-30 taking (n = 14) or not taking (n = 12) oral contraceptives (OC and NOC, respectively) were tested in the low hormone (LH) and high hormone (HH) conditions corresponding to the early follicular and mid-luteal phases (NOC) or placebo and high-dose pills (OC). Women underwent three randomized trials: (a) 3 min of passive leg movement (PLM), (b) 2 min of 40% maximal voluntary handgrip exercise followed by 2 min of post-exercise circulatory occlusion (PECO), and (c) 5 min of breathing 5% CO 2  . We primarily measured hemodynamics and ventilation. During PLM, the OC group had a smaller pressor response (p = .012). During PECO, the OC group similarly exhibited a smaller pressor response (p = .043) and also exhibited a greater ventilatory response (p = .024). Lastly, in response to breathing 5% CO 2  , women in the HH phase had a greater ventilatory response (p = .022). We found that OC use attenuates the pressor response to both the metaboreflex and mechanoreflex while increasing the ventilatory response to metaboreflex activation. We also found evidence of an enhanced CO 2  chemoreflex in the HH phase. We hypothesize that OC effects are from the chronic upregulation of pulmonary and vascular β-adrenergic receptors. We further suggest that the increased cyclic progesterone in the HH phase enhances the chemoreflex.",2020,"During PECO, the OC group similarly exhibited a smaller pressor response (p = .043) and also exhibited a greater ventilatory response (p = .024).","['Women aged 18-30 taking (n\xa0=\xa014) or not taking (n\xa0=\xa012) oral contraceptives (OC and NOC, respectively) were tested in the low hormone (LH) and high hormone (HH) conditions corresponding to the early follicular and mid-luteal phases (NOC) or']","['40% maximal voluntary handgrip exercise followed by 2\xa0min of post-exercise circulatory occlusion (PECO), and (c) 5\xa0min of breathing 5% CO 2  ', 'OC', 'Progesterone', 'placebo and high-dose pills (OC', '3\xa0min of passive leg movement (PLM']","['Oral contraceptives and menstrual cycle influence autonomic reflex function', 'ventilatory response', 'smaller pressor response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",,0.0281907,"During PECO, the OC group similarly exhibited a smaller pressor response (p = .043) and also exhibited a greater ventilatory response (p = .024).","[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Assadpour', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Ivry', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wasef', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Baithat', 'Initials': 'B', 'LastName': 'Adeyinka', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Murray', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Edgell', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}]",Physiological reports,['10.14814/phy2.14550']
1853,32865325,Comparing the effects of CAD/CAM nickel-titanium lingual retainers on teeth stability and periodontal health with conventional fixed and removable retainers: A randomized clinical trial.,"OBJECTIVE


The objectives of this study were to evaluate the effect of a CAD/CAM nickel-titanium retainer on the stability of mandibular anterior teeth and periodontal health and to compare it with other retainers.
SETTING/SAMPLE POPULATION


Sixty participants from both genders who had irregularities prior to orthodontic therapy and who had been treated with full-fixed appliance mechanotherapy were included in the study and randomly allocated into four groups: CAD/CAM NiTi, multi-stranded stainless steel, single-stranded nickel-free titanium and vacuum-formed removable retainer groups. The mean age of the participants at the end of the treatment was approximately 20 years.
MATERIALS AND METHODS


Digital impressions were taken for all participants at three different times: immediately (T 0  ), three months (T 1  ) and six months (T 2  ) after treatment. Irregularity index, inter-canine and inter-molar width, and arch length were recorded using software. Additionally, a full periodontal assessment was carried out at T 2  .
RESULTS


During the follow-ups, all groups showed some relapse in the lower anterior teeth. No statistical significance was found intergroup in terms of all measured values. Within the multi-stranded group, inter-canine width had decreased by 0.10 mm with a statistical significance (P = .048). An additional statistical significance with P = .045 was found within the single-stranded group regarding the increased arch length. The periodontal assessment results of the mandibular anterior teeth between groups did not show clinically significant differences.
CONCLUSION


No statistical significance was found between the CAD/CAM retainer and other retainers regarding the clinical failure rate. Less plaque accumulation and gingival inflammation were observed in the CAD/CAM NiTi retainer group.",2020,"Within the multi-stranded group, inter-canine width had decreased by 0.10mm with a statistical significance (P=0.048).",['60 participants from both genders who had irregularities prior to orthodontic therapy and who had been treated with full-fixed appliances mechanotherapy'],"['CAD/CAM Nickel Titanium lingual retainers', 'CAD/CAM NiTi retainer, multi-stranded stainless-steel, single-stranded nickel-free titanium, and vacuum-formed removable retainer groups', 'CAD/CAM Nickel-Titanium retainer', 'conventional fixed and removable retainers']","['teeth stability and periodontal health', 'Irregularity index, inter-canine and inter-molar width, and arch length', 'plaque accumulation and gingival inflammation', 'canine width', 'stability of mandibular anterior teeth and periodontal health']","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0242919', 'cui_str': 'Orthodontic retainer'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0038126', 'cui_str': 'Stainless steel material'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0028013', 'cui_str': 'nickel'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C4544584', 'cui_str': 'Distance between molar teeth'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",60.0,0.0503102,"Within the multi-stranded group, inter-canine width had decreased by 0.10mm with a statistical significance (P=0.048).","[{'ForeName': 'Mohamad Basel', 'Initials': 'MB', 'LastName': 'Alrawas', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Near East University, Nicosia, Turkey.'}, {'ForeName': 'Yaman', 'Initials': 'Y', 'LastName': 'Kashoura', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Near East University, Nicosia, Turkey.'}, {'ForeName': 'Özgür', 'Initials': 'Ö', 'LastName': 'Tosun', 'Affiliation': 'Department of Biostatistics, School of Medicine, Near East University, Nicosia, Turkey.'}, {'ForeName': 'Ulaş', 'Initials': 'U', 'LastName': 'Öz', 'Affiliation': 'Department of Orthodontics, School of Dentistry, Near East University, Nicosia, Turkey.'}]",Orthodontics & craniofacial research,['10.1111/ocr.12425']
1854,32861983,Can 'floating' predict treatment response to ketamine? Data from three randomized trials of individuals with treatment-resistant depression.,"Ketamine has rapid-acting antidepressant properties but also potentially concerning transient dissociative side effects (SEs). Recent studies noted a positive correlation between treatment response to ketamine and general dissociative SEs, as well as ""floating"", a depersonalization SE (a subtype of the dissociative SEs). This analysis sought to determine whether floating mediates treatment response to ketamine. Data were pooled from three double-blind, crossover, placebo-controlled ketamine clinical trials across which 82 participants with treatment-resistant depression (TRD) (44 with bipolar depression and 38 with major depressive disorder) received placebo and ketamine (0.5 mg/kg) infusions. SEs were actively solicited in a standardized fashion before and after ketamine infusion. The hypothesis that a post-infusion experience of floating would mediate antidepressant response to ketamine was assessed at 230 min post-infusion and at Day 1. Montgomery-Asberg Depression Rating Scale (MADRS) total score was the dependent variable in a linear mixed effects model. Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion. The hypothesized mediation effect of floating was also not detected at either 230 min or Day 1 post-infusion. Taken together, the findings do not support the hypothesis that ketamine's antidepressant effects are mediated by the dissociative depersonalization subtype SE of floating.",2020,"Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion.","['82 participants with treatment-resistant depression (TRD) (44 with bipolar depression and 38 with major depressive disorder', 'individuals with treatment-resistant depression']","['placebo and ketamine', 'ketamine', 'placebo-controlled ketamine', 'Ketamine']","['MADRS scores', 'floating and MADRS score', 'Montgomery-Asberg Depression Rating Scale (MADRS) total score']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.226109,"Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion.","[{'ForeName': 'Elia E', 'Initials': 'EE', 'LastName': 'Acevedo-Diaz', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. Electronic address: elia.acevedo@gmail.com.'}, {'ForeName': 'Grace W', 'Initials': 'GW', 'LastName': 'Cavanaugh', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Dede', 'Initials': 'D', 'LastName': 'Greenstein', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.06.012']
1855,32862007,Intranasal oxytocin increases respiratory rate and reduces obstructive event duration and oxygen desaturation in obstructive sleep apnea patients: a randomized double blinded placebo controlled study.,"BACKGROUND


Activation of the oxytocin network has shown benefits in animal models of Obstructive Sleep Apnea (OSA) as well as other cardiorespiratory diseases. We sought to determine if nocturnal intranasal oxytocin administration could have beneficial effects in reducing the duration and/or frequency of obstructive events in obstructive sleep apnea subjects.
METHODS


Two sequential standard ""in-lab"" polysomnogram (PSG) sleep studies were performed in patients diagnosed with OSA that were randomly assigned to initially receive either placebo or oxytocin (40 i.u.) administered intranasally in this double blinded randomized placebo controlled study. Changes in cardiorespiratory events during sleep, including apnea and hypopnea durations and frequency, risk of event-associated bradycardias, arterial oxygen desaturation and respiratory rate were assessed in 2 h epochs following sleep onset. Oxytocin significantly decreased the duration of obstructive events, as well as the oxygen desaturations and incidence of bradycardia that were associated with these events. Notably, oxytocin increased respiratory rate during non-obstructive periods. There were no significant changes in sleep architecture and no adverse effects were reported.
CONCLUSIONS


Oxytocin administration can benefit OSA subjects by reducing the duration and adverse consequences of obstructive events. Oxytocin could also be beneficial in situations involving respiratory depression as oxytocin increased respiratory rate. Additional studies are needed to further understand the mechanisms by which oxytocin promotes these changes in cardiorespiratory function. The long-term efficacy and optimal dose of intranasal oxytocin treatment should also be determined in OSA subjects. ClinicalTrials.gov NCT03148899.",2020,"Oxytocin significantly decreased the duration of obstructive events, as well as the oxygen desaturations and incidence of bradycardia that were associated with these events.","['obstructive sleep apnea subjects', 'Two sequential standard ""in-lab"" polysomnogram (PSG', 'obstructive sleep apnea patients', 'patients diagnosed with OSA', 'OSA subjects']","['oxytocin network', 'intranasal oxytocin', 'oxytocin', 'nocturnal intranasal oxytocin', 'placebo', 'Oxytocin', 'placebo or oxytocin', 'Intranasal oxytocin']","['duration of obstructive events', 'respiratory rate', 'cardiorespiratory events during sleep, including apnea and hypopnea durations and frequency, risk of event-associated bradycardias, arterial oxygen desaturation and respiratory rate', 'respiratory rate and reduces obstructive event duration and oxygen desaturation', 'oxygen desaturations and incidence of bradycardia', 'sleep architecture and no adverse effects']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0853204', 'cui_str': 'No adverse effect'}]",,0.200305,"Oxytocin significantly decreased the duration of obstructive events, as well as the oxygen desaturations and incidence of bradycardia that were associated with these events.","[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Kimbro', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Kowalik', 'Affiliation': 'Department of Biomedical Engineering, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Milojevic', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Maritza Dowling', 'Affiliation': 'Department of Acute & Chronic Care, School of Nursing, Department of Epidemiology & Biostatistics, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Anne Lloyd', 'Initials': 'AL', 'LastName': 'Hunley', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Hauser', 'Affiliation': 'Department of Pharmacology and Physiology, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Andrade', 'Affiliation': 'Centro de Fisiología Del Ejercicio, Universidad Mayor, Santiago, Chile; Laboratory of Cardiorespiratory Control, Department of Physiology, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Del Rio', 'Affiliation': 'Laboratory of Cardiorespiratory Control, Department of Physiology, Pontificia Universidad Católica de Chile, Santiago, Chile; Center for Aging and Regeneration (CARE-UC), Pontificia Universidad Católica de Chile, Santiago, Chile; Centro de Excelencia de Biomedicina en Magallanes (CEBIMA), Universidad de Magallanes, Punta Arenas, Chile.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Kay', 'Affiliation': 'Department of Biomedical Engineering, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mendelowitz', 'Affiliation': 'Department of Pharmacology and Physiology, The George Washington University, Washington, DC, USA. Electronic address: dmendel@gwu.edu.'}]",Sleep medicine,['10.1016/j.sleep.2020.05.034']
1856,32862009,Altered cortical gray matter volume and functional connectivity after transcutaneous spinal cord direct current stimulation in idiopathic restless legs syndrome.,"OBJECTIVE


To explore the neurophysiological mechanism of clinically effective transcutaneous spinal cord direct current stimulation (tsDCS) on idiopathic restless legs syndrome (RLS), structural magnetic resonance imaging (sMRI), and resting-state functional MRI (rs-fMRI) were applied to reveal the structural and functional changes in idiopathic RLS patients after tsDCS.
METHODS


Thirty idiopathic RLS patients and 20 gender- and age-matched healthy controls (HC) were enrolled. All patients were randomly divided into anodal treatment group and sham treatment group and were treated with tsDCS for 2 weeks. The international RLS Rating Scale (IRLS-RS) and Pittsburgh Sleep Quality Index (PSQI) were used to evaluate the severity of RLS and sleep quality respectively. The sMRI and rs-fMRI data of anodal treatment group and HC were collected. Voxel-based morphology (VBM) and resting-state functional connectivity analysis were used to assess the change of cortical gray matter volume (GMV) and corresponding functional connectivity (FC) respectively in anodal treatment group after tsDCS treatment.
RESULTS


Sham treatment group showed no significant change in IRLS-RS and PSQI scores after tsDCS, while significant decrease scores were observed in anodal treatment group, and the improvement sustained up to 2 weeks. Anodal treatment group showed significant regional decrease of GMV in bilateral cuneus compared to the HC. After tsDCS treatment, the GMV in the bilateral cuneus and left ventral post central gyrus (PoCG_L) decreased significantly. The FC between bilateral cuneus and left primary visual cortex (V1_L), and between right cuneus (Cune_R) and right lingual gyrus (LG_R) increased significantly after tsDCS, whereas the FC between PoCG_L and supplementary motor area (SMA) decreased significantly. The changed FC between PoCG_L and SMA, between Cune_R and V1_L were correlated with the changed IRLS-RS.
CONCLUSION


Disturbance of sensorimotor network and visual processing network may be involved in the pathogenesis of RLS. tsDCS probably can regulate FC in the sensorimotor cortex and visual processing cortex to relieve the symptom of RLS. Continuous tsDCS may improve the symptoms of RLS patients for a long time. tsDCS probably could provide a potential non-pharmacologic treatment for idiopathic RLS patients.",2020,Anodal treatment group showed significant regional decrease of GMV in bilateral cuneus compared to the HC.,"['idiopathic restless legs syndrome (RLS', 'idiopathic RLS patients after tsDCS', 'idiopathic restless legs syndrome', 'idiopathic RLS patients', 'Thirty idiopathic RLS patients and 20 gender- and age-matched healthy controls (HC) were enrolled']","['transcutaneous spinal cord direct current stimulation (tsDCS', 'transcutaneous spinal cord direct current stimulation', 'anodal treatment group and sham treatment group and were treated with tsDCS', 'tsDCS']","['change of cortical gray matter volume (GMV) and corresponding functional connectivity (FC', 'international RLS Rating Scale (IRLS-RS) and Pittsburgh Sleep Quality Index (PSQI', 'bilateral cuneus and left ventral post central gyrus (PoCG_L', 'FC between PoCG_L and supplementary motor area (SMA', 'IRLS-RS and PSQI scores', 'regional decrease of GMV in bilateral cuneus', 'FC between bilateral cuneus and left primary visual cortex (V1_L), and between right cuneus (Cune_R) and right lingual gyrus (LG_R']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152307', 'cui_str': 'Structure of cuneus'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0152302', 'cui_str': 'Structure of postcentral gyrus'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0038446', 'cui_str': 'Area striata structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}]",30.0,0.0317877,Anodal treatment group showed significant regional decrease of GMV in bilateral cuneus compared to the HC.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Jiaojian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China. Electronic address: jiaojianwang@uestc.edu.com.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China. Electronic address: wangyuping01@sina.cn.'}]",Sleep medicine,['10.1016/j.sleep.2020.07.026']
1857,32867560,Provider-adolescent discussion and provider education about asthma triggers during pediatric visits: results of a randomized trial.,"OBJECTIVE


We examined how an asthma question prompt list with video intervention influenced discussion of and provider education about asthma triggers.
METHODS


English or Spanish-speaking adolescents ages 11-17 with persistent asthma and their caregivers were enrolled from four pediatric clinics. Adolescents were randomized to the intervention or usual care groups. Adolescents in the intervention group watched the video on an iPad and then completed a one-page asthma question prompt list before their visits. All visits were audio-recorded. Generalized Estimating Equations were used to predict the number of trigger areas discussed and the number of areas providers educated adolescents about during visits.
RESULTS


Forty providers and 359 patients participated. Triggers were discussed during 89% of intervention group visits and 81% of usual care visits; providers educated adolescents about triggers during 59% of intervention group visits and 46% of usual care visits. More triggers were significantly more likely to be discussed and providers educated about more trigger areas during visits of adolescents in the intervention group and when adolescents asked one or more questions during visits. More trigger areas were significantly more likely to be discussed if the adolescent was White and male. Providers were significantly more likely to educate adolescents whose family spoke Spanish at home about more trigger areas than adolescents who spoke English at home.
CONCLUSIONS


More trigger areas were significantly more likely to be discussed and providers educated about more trigger areas during visits of adolescents who received the intervention and when adolescents asked one or more questions.",2020,Triggers were discussed during 89% of intervention group visits and 81% of usual care visits; providers educated adolescents about triggers during 59% of intervention group visits and 46% of usual care visits.,"['Pediatric Visits', 'Adolescents', 'Results:  Forty providers and 359 patients participated', 'English or Spanish-speaking adolescents ages 11-17 with persistent asthma and their caregivers were enrolled from four pediatric clinics']",['video intervention'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0288804,Triggers were discussed during 89% of intervention group visits and 81% of usual care visits; providers educated adolescents about triggers during 59% of intervention group visits and 46% of usual care visits.,"[{'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Sleath', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Delesha M', 'Initials': 'DM', 'LastName': 'Carpenter', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Davis', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Sayner', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Alexor LLC, Morrisville, NC, USA.'}, {'ForeName': 'Ceila E', 'Initials': 'CE', 'LastName': 'Loughlin', 'Affiliation': 'Department of Pediatric Pulmonology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Nacire', 'Initials': 'N', 'LastName': 'Garcia', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Reuland', 'Affiliation': 'Division of General Internal Medicine and Clinical Epidemiology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Tudor', 'Affiliation': 'Health Professions at Southern, New Hampshire University, Manchester, NH, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1817936']
1858,32868537,Does Episodic Future Thinking Repair Immediacy Bias at Home and in the Laboratory in Patients With Prediabetes?,"OBJECTIVE


This study aimed to determine if episodic future thinking (EFT) can decrease delay discounting (DD) among adults with prediabetes both in and out of the laboratory. DD measures how much the value of a reinforcer decreases as a function of the delay to receive it.
METHODS


Adults with prediabetes (n = 67) completed a three-session study. At session 1, baseline measures (including DD) were collected. At sessions 2 and 3, participants were prompted to engage in either EFT or control episodic thinking (CET) while completing DD and other measures. In addition, between the completion of sessions 2 and 3, participants engaged in EFT or CET at home and completed DD tasks remotely via smartphones or other Internet-connected devices.
RESULTS


Results showed significant -1.2759 (-20.24%) reductions in DD in the EFT group compared with a + 0.0287 (+0.46%) DD increase in the CET group (p = .0149) in the laboratory; and -0.4095 (-8.85%) reduction in DD in the EFT group compared with a + 0.2619 (+5.64%) increase in the CET group (p = .011) at home. Working memory (measured by Backwards Corsi and Digit Span) was found to moderate the effects of EFT on some measures of DD. EFT did not change measures from the food purchase task or a food ad libitum procedure.
CONCLUSIONS


Results show that EFT decreases DD in and out of the laboratory and supports the further exploration of EFT as an intervention for prediabetes and related chronic diseases.
CLINICAL TRIAL REGISTRATION


NCT03664726.",2020,"RESULTS


Results showed significant -1.2759 (-20.24%) reductions in DD in the EFT group compared with a + 0.0287 (+0.46%) DD increase in the CET group (p = .0149) in the laboratory; and -0.4095 (-8.85%) reduction in DD in the EFT group compared with a + 0.2619 (+5.64%) increase in the CET group (p = .011) at home.","['adults with prediabetes both in and out of the laboratory', 'Adults with prediabetes (n = 67', 'Patients With Prediabetes']","['EFT or control episodic thinking (CET', 'EFT or CET', 'EFT', 'CET', 'episodic future thinking (EFT']","['delay discounting (DD', 'Working memory', 'reductions in DD', 'reduction in DD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",67.0,0.0525084,"RESULTS


Results showed significant -1.2759 (-20.24%) reductions in DD in the EFT group compared with a + 0.0287 (+0.46%) DD increase in the CET group (p = .0149) in the laboratory; and -0.4095 (-8.85%) reduction in DD in the EFT group compared with a + 0.2619 (+5.64%) increase in the CET group (p = .011) at home.","[{'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'From the Fralin Biomedical Research Institute at VTC (Bickel, Stein, Mellis, Athamneh, Greenawald, Gatchalian), Roanoke, Virginia; and University at Buffalo Jacobs School of Medicine and Biomedical Sciences (Paluch, Quattrin, Bree, Mastrandrea, Epstein), Buffalo, New York.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Rocco A', 'Initials': 'RA', 'LastName': 'Paluch', 'Affiliation': ''}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Mellis', 'Affiliation': ''}, {'ForeName': 'Liqa N', 'Initials': 'LN', 'LastName': 'Athamneh', 'Affiliation': ''}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Quattrin', 'Affiliation': ''}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Greenawald', 'Affiliation': ''}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Bree', 'Affiliation': ''}, {'ForeName': 'Kirstin M', 'Initials': 'KM', 'LastName': 'Gatchalian', 'Affiliation': ''}, {'ForeName': 'Lucy D', 'Initials': 'LD', 'LastName': 'Mastrandrea', 'Affiliation': ''}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000841']
1859,32866454,"An Electronically delivered, Patient-activation tool for Intensification of medications for Chronic Heart Failure with reduced ejection fraction: Rationale and design of the EPIC-HF trial.","BACKGROUND


Heart failure with reduced ejection fraction (HFrEF) benefits from initiation and intensification of multiple pharmacotherapies. Unfortunately, there are major gaps in the routine use of these drugs. Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients.
HYPOTHESIS


Encouraging patients to engage providers in HFrEF prescribing decisions will improve the use of guideline-directed medical therapies.
DESIGN


The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient-activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing. The study assesses the effectiveness of the EPIC-HF intervention to improve guideline-directed medical therapy in the month after its delivery while using an implementation design to also understand the reach, adoption, implementation, and maintenance of this approach within the context of real-world care delivery. Study enrollment was completed in January 2020, with a total 305 patients. Baseline data revealed significant opportunities, with <1% of patients on optimal HFrEF medical therapy.
SUMMARY


The EPIC-HF trial assesses the implementation, effectiveness, and safety of patient engagement in HFrEF prescribing decisions. If successful, the tool can be easily disseminated and may inform similar interventions for other chronic conditions.",2020,"The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing.","['Study enrollment was completed January 2020, with a total 305 patients', 'chronic heart failure with reduced ejection fraction', 'Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient']","['activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits', 'EPIC-HF intervention']",[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4280934', 'cui_str': 'Reduced ejection fraction co-occurrent and due to chronic heart failure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3810847', 'cui_str': 'Cardiology clinic'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0376458,"The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing.","[{'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Venechuk', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Prateeti', 'Initials': 'P', 'LastName': 'Khazanie', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Page', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences Aurora, CO.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Knoepke', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Helmkamp', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Peterson', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Pierce', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Jocelyn S', 'Initials': 'JS', 'LastName': 'Thompson', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'UCHealth Memorial Hospital, Colorado Springs, CO.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Strader', 'Affiliation': 'UCHealth Memorial Hospital, Colorado Springs, CO.'}, {'ForeName': 'Tristan J', 'Initials': 'TJ', 'LastName': 'Dow', 'Affiliation': 'UCHealth Poudre Valley Hospital, Loveland, CO.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Richards', 'Affiliation': 'UCHealth Poudre Valley Hospital, Loveland, CO.'}, {'ForeName': 'Katy E', 'Initials': 'KE', 'LastName': 'Trinkley', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences Aurora, CO.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kao', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Colleen K', 'Initials': 'CK', 'LastName': 'McIlvennan', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Magid', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Buttrick', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO. Electronic address: larry.allen@cuanschutz.edu.'}]",American heart journal,['10.1016/j.ahj.2020.08.013']
1860,32869956,"Impact of a weight loss and fitness intervention on exercise-associated plasma oxylipin patterns in obese, insulin-resistant, sedentary women.","Very little is known about how metabolic health status, insulin resistance or metabolic challenges modulate the endocannabinoid (eCB) or polyunsaturated fatty acid (PUFA)-derived oxylipin (OxL) lipid classes. To address these questions, plasma eCB and OxL concentrations were determined at rest, 10 and 20 min during an acute exercise bout (30 min total, ~45% of preintervention V̇O 2peak  , ~63 W), and following 20 min recovery in overnight-fasted sedentary, obese, insulin-resistant women under controlled diet conditions. We hypothesized that increased fitness and insulin sensitivity following a ~14-week training and weight loss intervention would lead to significant changes in lipid signatures using an identical acute exercise protocol to preintervention. In the first 10 min of exercise, concentrations of a suite of OxL diols and hydroxyeicosatetraenoic acid (HETE) metabolites dropped significantly. There was no increase in 12,13-DiHOME, previously reported to increase with exercise and proposed to activate muscle fatty acid uptake and tissue metabolism. Following weight loss intervention, exercise-associated reductions were more pronounced for several linoleate and alpha-linolenate metabolites including DiHOMEs, DiHODEs, KODEs, and EpODEs, and fasting concentrations of 9,10-DiHODE, 12,13-DiHODE, and 9,10-DiHOME were reduced. These findings suggest that improved metabolic health modifies soluble epoxide hydrolase, cytochrome P450 epoxygenase (CYP), and lipoxygenase (LOX) systems. Acute exercise led to reductions for most eCB metabolites, with no evidence for concentration increases even at recovery. It is proposed that during submaximal aerobic exercise, nonoxidative fates of long-chain saturated, monounsaturated, and PUFAs are attenuated in tissues that are important contributors to the blood OxL and eCB pools.",2020,"Following weight loss intervention, exercise-associated reductions were more pronounced for several linoleate and alpha-linolenate metabolites including DiHOMEs, DiHODEs, KODEs, and EpODEs, and fasting concentrations of 9,10-DiHODE, 12,13-DiHODE, and 9,10-DiHOME were reduced.","['obese, insulin-resistant, sedentary women']",['weight loss and fitness intervention'],"['fitness and insulin sensitivity', 'plasma eCB and OxL concentrations', 'activate muscle fatty acid uptake and tissue metabolism', 'concentrations of a suite of OxL diols and hydroxyeicosatetraenoic acid (HETE) metabolites', 'several linoleate and alpha-linolenate metabolites including DiHOMEs, DiHODEs, KODEs, and EpODEs, and fasting concentrations of 9,10-DiHODE, 12,13-DiHODE, and 9,10-DiHOME']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0020349', 'cui_str': 'Hydroxyeicosatetraenoic acid'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0220871', 'cui_str': 'linoleate'}, {'cui': 'C1370209', 'cui_str': 'Alpha linolenate'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",,0.0529124,"Following weight loss intervention, exercise-associated reductions were more pronounced for several linoleate and alpha-linolenate metabolites including DiHOMEs, DiHODEs, KODEs, and EpODEs, and fasting concentrations of 9,10-DiHODE, 12,13-DiHODE, and 9,10-DiHOME were reduced.","[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Grapov', 'Affiliation': 'CDS-Creative Data Solutions, Davis, CA, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Fiehn', 'Affiliation': 'West Coast Metabolomics Center, University of California, Davis, CA, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Chandler', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Dustin J', 'Initials': 'DJ', 'LastName': 'Burnett', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Souza', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Gretchen A', 'Initials': 'GA', 'LastName': 'Casazza', 'Affiliation': 'Department of Kinesiology, California State University, Sacramento, CA, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Keim', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Hunter', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Fernandez', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Hoppel', 'Affiliation': 'Pharmacology Department, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Harper', 'Affiliation': 'Department of Biochemistry, Microbiology and Immunology, and Ottawa Institute of Systems Biology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newman', 'Affiliation': 'United States Department of Agriculture-Agricultural Research Service Western Human Nutrition Research Center, Davis, CA, USA.'}, {'ForeName': 'Sean H', 'Initials': 'SH', 'LastName': 'Adams', 'Affiliation': ""Arkansas Children's Nutrition Center, Little Rock, AR, USA.""}]",Physiological reports,['10.14814/phy2.14547']
1861,32871454,Difficulties in developmental follow-up of preterm neonates in a randomised-controlled trial of Bifidobacterium breve M16-V - Experience from Western Australia.,"BACKGROUND


Probiotics may be neuroprotective for preterm neonates due to their anti-inflammatory effects and ability to facilitate nutrition.
AIM


To assess long-term effects of early probiotic supplementation on neuropsychological development in preterm infants.
STUDY DESIGN


Follow up study.
SUBJECTS


Children at age 3 to 5 years who had participated as preterm infants (<33 week) in the randomised controlled trial.
OUTCOMES


Primary: Continuous early learning composite measure derived from the Mullen's Scale of Early Learning (MSEL). Other outcomes were assessed by the Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition.
MEASURES


Continuous scores derived from all the measures.
RESULTS


67 children of the 159 participants (42%) (Probiotic: 36/79, Placebo: 31/80) were followed-up for at least one neuropsychological assessment. All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children. Multivariable analysis of MSEL composite score showed no evidence of probiotic effect univariately, or after adjustment for gestation, intrauterine growth restriction, Apgar <7 at 5 min and age at assessment (adjusted mean effect in probiotic group: -2.7, 95% CI -8.5-3.0, p = 0.349).
CONCLUSION


There was no significant effect on neurodevelopment of children assessed at the age of 3 to 5 years who participated as preterm neonates in the RCT of B. breve M-16V. The validity of these results is limited by the reduced sample size due to high rate of loss to follow up.",2020,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"['preterm infants', 'Children at age 3 to 5\xa0years who had participated as preterm infants (<33\xa0week', 'preterm neonates', '67 children of the 159 participants (42', 'from Western Australia']","['early probiotic supplementation', 'Placebo', 'Bifidobacterium breve M16-V - Experience', 'M-16V']","[""Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition"", ""Mullen's Scale of Early Learning (MSEL""]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3875061', 'cui_str': 'Developmental, dimensional and diagnostic interview'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",159.0,0.215666,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia. Electronic address: sachin.agrawal@health.wa.gov.au.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granich', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Neonatal Pediatrics, Perth Children Hospital, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Women and Infants Research Foundation, King Edward Memorial Hospital for Women, 374, Bagot Road, Subiaco, Perth, WA, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wray', 'Affiliation': 'Child Development Centre, 4/16 Rheola St, West Perth, WA 6005, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}, {'ForeName': 'A J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patole', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}]",Early human development,['10.1016/j.earlhumdev.2020.105165']
1862,32873572,Efficacy and Safety of Nivolumab Plus Ipilimumab versus Sunitinib in First-line Treatment of Patients with Advanced Sarcomatoid Renal Cell Carcinoma.,"PURPOSE


Patients with advanced renal cell carcinoma with sarcomatoid features (sRCC) have poor prognoses and suboptimal outcomes with targeted therapy. This  post hoc  analysis of the phase III CheckMate 214 trial analyzed the efficacy of nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib in patients with sRCC.
PATIENTS AND METHODS


Patients with sRCC were identified via independent central pathology review of archival tumor tissue or histologic classification per local pathology report. Patients were randomized 1:1 to receive nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks (four doses) then nivolumab 3 mg/kg every 2 weeks, or sunitinib 50 mg orally every day (4 weeks; 6-week cycles). Outcomes in patients with sRCC were not prespecified. Endpoints in patients with sRCC and International Metastatic Renal Cell Carcinoma Database Consortium intermediate/poor-risk disease included overall survival (OS), progression-free survival (PFS) per independent radiology review, and objective response rate (ORR) per RECIST v1.1. Safety outcomes used descriptive statistics.
RESULTS


Of 1,096 randomized patients in CheckMate 214, 139 patients with sRCC and intermediate/poor-risk disease and six with favorable-risk disease were identified. With 42 months' minimum follow-up in patients with sRCC and intermediate/poor-risk disease, median OS [95% confidence interval (CI)] favored NIVO+IPI [not reached (NR) (25.2-not estimable [NE]);  n  = 74] versus sunitinib [14.2 months (9.3-22.9);  n  = 65; HR, 0.45 (95% CI, 0.3-0.7;  P  = 0.0004)]; PFS benefits with NIVO+IPI were similarly observed [median 26.5 vs. 5.1 months; HR, 0.54 (95% CI, 0.33-0.86;  P  = 0.0093)]. Confirmed ORR was 60.8% with NIVO+IPI versus 23.1% with sunitinib, with complete response rates of 18.9% versus 3.1%, respectively. No new safety signals emerged.
CONCLUSIONS


NIVO+IPI showed unprecedented long-term survival, response, and complete response benefits versus sunitinib in previously untreated patients with sRCC and intermediate/poor-risk disease, supporting the use of first-line NIVO+IPI for this population.",2020,"CONCLUSIONS


NIVO+IPI showed unprecedented long-term survival, response and complete response benefits versus SUN in previously untreated patients with sRCC and intermediate/poor-risk disease, supporting the use of first-line NIVO+IPI for this population.","['patients with sRCC', 'Patients with Advanced Sarcomatoid Renal Cell Carcinoma', 'patients with sRCC and IMDC intermediate/poor-risk disease included', '139 patients with sRCC and intermediate/poor-risk disease and six with favorable-risk disease', 'Patients with advanced renal cell carcinoma with sarcomatoid features (sRCC', '1096 randomized patients in CheckMate 214', 'Patients with sRCC were identified via independent central pathology review of archival tumor tissue or histological classification per local pathology report']","['Nivolumab Plus Ipilimumab', 'NIVO 3 mg/kg Q2W, or SUN 50 mg orally QD', 'nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib (SUN', 'NIVO (3 mg/kg) plus IPI']","['overall survival (OS), progression-free survival (PFS) per independent radiology review, and objective response rate (ORR', 'complete response rates', 'ORR', 'intermediate/poor-risk disease, median OS', 'Efficacy and Safety', 'long-term survival, response and complete response benefits versus SUN', 'PFS benefits with NIVO+IPI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1266043', 'cui_str': 'Renal cell carcinoma, sarcomatoid'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0807321', 'cui_str': 'Pathology report'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1696717', 'cui_str': 'sunitinib 50 MG [Sutent]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0668760', 'cui_str': 'diinosine pentaphosphate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]",1096.0,0.0627441,"CONCLUSIONS


NIVO+IPI showed unprecedented long-term survival, response and complete response benefits versus SUN in previously untreated patients with sRCC and intermediate/poor-risk disease, supporting the use of first-line NIVO+IPI for this population.","[{'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas. ntannir@mdanderson.org.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Signoretti', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Division of Medical Oncology, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Abdallah', 'Initials': 'A', 'LastName': 'Flaifel', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Pignon', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ficial', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Osvaldo Arén', 'Initials': 'OA', 'LastName': 'Frontera', 'Affiliation': 'Centro de Investigación Clínica Bradford Hill, Recoleta, Chile.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Urology, Barts Cancer Institute, Queen Mary University of London, Royal Free NHS Trust, London, United Kingdom.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Harrison', 'Affiliation': 'Department of Medicine, Duke Cancer Institute, Durham, North Carolina.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthélémy', 'Affiliation': 'Medical Oncology Unit, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Tykodi', 'Affiliation': 'Department of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Kocsis', 'Affiliation': 'Oncology Department, Debrecen University Clinical Center, Debrecen, Hungary.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Department of Medical Oncology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Jeronimo R', 'Initials': 'JR', 'LastName': 'Rodriguez-Cid', 'Affiliation': 'Centro Oncológico, Hospital Médica Sur, Mexico City, Mexico.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, California.'}, {'ForeName': 'Andre M', 'Initials': 'AM', 'LastName': 'Murad', 'Affiliation': 'CENANTRON-PERSONAL-Precision Oncology, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Ishii', 'Affiliation': 'Department of Clinical Trials, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Shruti Shally', 'Initials': 'SS', 'LastName': 'Saggi', 'Affiliation': 'Department of Clinical Trials, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Department of Biostatistics, Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Division of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2063']
1863,32875638,"Comparison of a polyethylene glycol membrane and a collagen membrane for the treatment of bone dehiscence defects at bone level implants-A prospective, randomized, controlled, multicenter clinical trial.","OBJECTIVES


The aim of the present randomized, controlled clinical multicenter trial was to compare a polyethylene glycol (PEG) and a native collagen membrane (BG) for simultaneous guided bone regeneration at bony dehiscence-type defects around bone level titanium implants.
MATERIAL AND METHODS


The study enrolled 117 patients requiring implant treatment in the posterior maxilla or mandible with expected buccal bony dehiscence-type defects at the placed titanium implants. According to a parallel groups design, defects were filled with a synthetic bone filler and randomly assigned to either PEG or BG membrane. As primary parameter, the relative vertical bone fill was assessed at baseline and at re-entry after 6 months of healing. As secondary parameters, the marginal bone level (MBL) was assessed radiographically and soft tissue conditions were recorded up to 18 months postloading.
RESULTS


Both groups showed comparable vertical bone fill revealing a relative change in defect height of 59.7% (PEG) and 64.4% (BG). The absolute mean reduction in defect size was 2.5 mm in the PEG group and 3.2 mm in the BG group. Although both groups revealed a statistically significant mean defect reduction (p < .001), a comparison between the two groups did not show statistical significances. The non-inferiority test with inferiority limit of -5% could not be rejected, based on the 90% confidence interval of the differences of the two means with lower limit -15.4%. After 18 months, an MBL increase of 0.45 ± 0.43 mm in the PEG group and 0.41 ± 0.81 mm in the BG group was detected (p < .001). Soft tissue complications were observed in both groups without showing statistical significance.
CONCLUSIONS


Both membranes supported bone regeneration at dehiscence-type defects and obtained vertical bone fill with a relative change in defect height of 59.7% (PEG) and 64.4% (BG); however, the non-inferiority of PEG could not be shown.",2020,"Both membranes supported bone regeneration at dehiscence-type defects and obtained vertical bone fill with a relative change in defect height of 59.7% (PEG) and 64.4% (BG), however the non-inferiority of PEG could not be shown.","['117 patients requiring implant treatment in the posterior maxilla or mandible with expected buccal bony dehiscence-type defects at the placed titanium implants', 'bone dehiscence defects at bone level implants ']","['polyethylenglycol (PEG) and a native collagen membrane (BG', 'polyethylene glycol membrane and a collagen membrane', 'synthetic bone filler and randomly assigned to either PEG or BG membrane']","['radiographically and soft tissue conditions', 'MBL increase', 'Soft tissue complications', 'marginal bone level (MBL', 'relative vertical bone fill']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0443157', 'cui_str': 'Bony'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0729441', 'cui_str': 'Filler'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}]",117.0,0.11526,"Both membranes supported bone regeneration at dehiscence-type defects and obtained vertical bone fill with a relative change in defect height of 59.7% (PEG) and 64.4% (BG), however the non-inferiority of PEG could not be shown.","[{'ForeName': 'Ronald Ernst', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ilja', 'Initials': 'I', 'LastName': 'Mihatovic', 'Affiliation': 'Department of Oral Surgery, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cordaro', 'Affiliation': 'Department of Periodontics and Prosthodontics, Policlinico Umberto I, Eastman Dental Hospital, Rome, Italy.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Windisch', 'Affiliation': 'Department of Periodontology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Friedmann', 'Affiliation': 'Department of Periodontology, School of Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Blanco Carrion', 'Affiliation': 'Periodontology Unit, School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Sanz Sanchez', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Public Health Service, Gävle, Sweden.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Quirynen', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Christoph H F', 'Initials': 'CHF', 'LastName': 'Hammerle', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}]",Clinical oral implants research,['10.1111/clr.13657']
1864,32871529,"Changes in glenohumeral translation, electromyographic activity, and pressure-pain thresholds following sustained or oscillatory mobilizations in stiff and healthy shoulders: Results of a randomized, controlled laboratory trial.","STUDY DESIGN


Randomized Controlled Laboratory Study.
BACKGROUND


Posterior glide glenohumeral (GH) mobilizations are utilized to improve motion and decrease pain in patients with shoulder pathologies, thought to be due to capsular stretch and neurophysiologic effects. However, it remains unclear how different GH mobilizations influence mobility, rotator cuff (RC) activity, and pain processing, or if effects are different in stiff (≥15-degree loss of passive motion in any plane) rather than healthy shoulders.
OBJECTIVES


To compare the effects of oscillatory and sustained posterior GH mobilizations on translation, RC activity, and pressure pain threshold (PPT) in stiff and healthy shoulders.
METHODS


Eighty-eight participants, (44 control, 44 stiff shoulders) were randomly assigned to one of two mobilization conditions. Pre-post intervention measurements of PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography were performed. Sustained or oscillatory grade III posterior GH mobilizations were then provided to all participants. Data were analyzed using tests of difference and regression modeling.
RESULTS


Sustained glides (2.8 ± 3.3 mm) demonstrated significantly greater changes in translation compared to oscillatory glides (1.1 ± 3.9 mm), p = .028. Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01). Small changes in PPT occurred across all conditions, none reaching clinically meaningful levels.
CONCLUSION


Sustained mobilizations resulted in greater changes in GH translation. RC activity was higher in the stiff shoulder group, and remained higher post-intervention despite gains in GH translation, suggesting a mechanical rather than neurophysiologic effect. There was no meaningful difference in PPT between modes of mobilization.
LEVEL OF EVIDENCE


Therapy, Randomized Controlled Laboratory Study, Level 1b.",2020,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","['stiff and healthy shoulders', 'patients with shoulder pathologies', 'Eighty-eight participants, (44 control, 44 stiff shoulders']","['Posterior glide glenohumeral (GH) mobilizations', 'sustained or oscillatory mobilizations', 'oscillatory and sustained posterior GH mobilizations']","['glenohumeral translation, electromyographic activity, and pressure-pain thresholds', 'GH translation', 'RC activity', 'PPT, GH translation via ultrasound imaging, and RC activity assessed via electromyography', 'PPT', 'total RC activity', 'mobility, rotator cuff (RC) activity, and pain processing', 'translation, RC activity, and pressure pain threshold (PPT']","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0241042', 'cui_str': 'Shoulder stiff'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",88.0,0.18114,"Stiff shoulders demonstrated higher total RC activity than controls both pre (+24.51%, p = .004) and post-intervention (+23.10%, p = .01).","[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Swanson', 'Affiliation': 'University of Hartford, West Hartford, CT, USA; University of New England, Portland, ME, USA. Electronic address: bswanson@Hartford.edu.'}, {'ForeName': 'J Adrienne', 'Initials': 'JA', 'LastName': 'McAuley', 'Affiliation': 'University of New England, Portland, ME, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lawrence', 'Affiliation': 'University of New England, Portland, ME, USA.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102243']
1865,32871329,Rationale and design of the MULTISTARS AMI Trial: A randomized comparison of immediate versus staged complete revascularization in patients with ST-segment elevation myocardial infarction and multivessel disease.,"About half of patients with acute ST-segment elevation myocardial infarction (STEMI) present with multivessel coronary artery disease (MVD). Recent evidence supports complete revascularization in these patients. However, optimal timing of non-culprit lesion revascularization in STEMI patients is unknown because dedicated randomized trials on this topic are lacking. STUDY DESIGN: The MULTISTARS AMI trial is a prospective, international, multicenter, randomized, two-arm, open-label study planning to enroll at least 840 patients. It is designed to investigate whether immediate complete revascularization is non-inferior to staged (within 19-45 days) complete revascularization in patients in stable hemodynamic conditions presenting with STEMI and MVD and undergoing primary percutaneous coronary intervention (PCI). After successful primary PCI of the culprit artery, patients are randomized in a 1:1 ratio to immediate or staged complete revascularization. The primary endpoint is a composite of all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year. CONCLUSIONS: The MULTISTARS AMI trial tests the hypothesis that immediate complete revascularization is non-inferior to staged complete revascularization in stable patients with STEMI and MVD.",2020,"The primary endpoint is a composite of all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year.","['patients with ST-segment elevation myocardial infarction and multivessel disease', 'patients in stable hemodynamic conditions presenting with STEMI and MVD and undergoing primary percutaneous coronary intervention (PCI', 'enroll at least 840 patients', 'patients with acute ST-segment elevation myocardial infarction (STEMI) present with multivessel coronary artery disease (MVD']",['immediate versus staged complete revascularization'],"['composite of all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.110186,"The primary endpoint is a composite of all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, hospitalization for heart failure, and stroke at 1 year.","[{'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Stähli', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Infermi Hospital, Rivoli, Turin, Italy.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Schwarz', 'Affiliation': 'Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital for the Universities of Kiel, Lübeck and Hamburg, Bad Segeberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordbeck', 'Affiliation': 'Department of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Stephan B', 'Initials': 'SB', 'LastName': 'Felix', 'Affiliation': 'Department of Internal Medicine B, University Medicine Greifswald, Greifswald, and DZHK (German Centre for Cardiovascular Research), Partner Site Greifswald, Germany.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Lang', 'Affiliation': 'Department of Internal Medicine II, Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Aurel', 'Initials': 'A', 'LastName': 'Toma', 'Affiliation': 'Department of Internal Medicine II, Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moccetti', 'Affiliation': 'Fondazione Cardiocentro Ticino, Lugano, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Valina', 'Affiliation': 'Division of Cardiology and Angiology II, University Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Vercellino', 'Affiliation': 'Department of Internal Medicine, Santi Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.'}, {'ForeName': 'Angelos G', 'Initials': 'AG', 'LastName': 'Rigopoulos', 'Affiliation': 'Mid-German Heart Center, Department of Internal Medicine III (KIM-III), Division of Cardiology, Angiology and Intensive Medical Care, University Hospital Halle, Martin-Luther-University Halle, Halle, Germany.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Rohla', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital and Sigmund Freud University, Medical School, Vienna, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schindler', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wischnewsky', 'Affiliation': 'FB Mathematics and Computer Science, University of Bremen, Bremen, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Linke', 'Affiliation': 'Technische Universität Dresden, Department of Internal Medicine and Cardiology, Herzzentrum Dresden, University Clinic, Dresden, Germany.'}, {'ForeName': 'P Christian', 'Initials': 'PC', 'LastName': 'Schulze', 'Affiliation': 'Department of Internal Medicine I, Division of Cardiology, Pneumology, Angiology and Intensive Medical Care, University Hospital Jena, Friedrich-Schiller-University Jena, Jena, Germany.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital for the Universities of Kiel, Lübeck and Hamburg, Bad Segeberg, Germany.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'Clinic and Policlinic Internal Medicine I (Cardiology and Angiology), Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Weidinger', 'Affiliation': '2(nd) Medical Department with Cardiology and Intensive Care Medicine, Rudolfstiftung Hospital, Vienna, Austria.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Rottbauer', 'Affiliation': 'Internal Medicine II, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': 'Department of Cardiology, Friedrich-Alexander-University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital and Sigmund Freud University, Medical School, Vienna, Austria.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Division of Cardiology and Angiology II, University Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität, Munich, and DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ruschitzka', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Willibald', 'Initials': 'W', 'LastName': 'Maier', 'Affiliation': 'Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland. Electronic address: willibald.maier@uzh.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.07.016']
1866,32871336,Single dose testosterone administration modulates the temporal dynamics of distractor processing.,"Some evidence suggests that testosterone can increase attentional orientation toward biologically relevant stimuli and increase sustained attention during goal-oriented behaviors. While rare irregular distractors often capture attention involuntarily and distract us away from the task at hand, we hypothesized that testosterone might (1) facilitate attentional orientation to novel distractors that are of potential behavioral relevance and (2) inhibit information processing of distractors that are irrelevant to the task. To test this hypothesis, we investigated the effects of testosterone on distractor processing in a novelty oddball task, during which infrequent target and distractor sounds were interspersed within a series of frequent non-target sounds. Using a double-blind, placebo-controlled within-participant design, we administered a single dose of either testosterone or placebo to 34 healthy male volunteers and compared their electroencephalographic responses to distractors. Increased amplitude of the early (260-310 ms) P3 component-which has been associated with phasic arousal and alertness triggered by novel stimuli-was observed in the testosterone session than in the placebo session. This early-P3 response mediated the effect of testosterone administration on target hit rate during the task. In addition, less α-oscillation suppression-which has been associated with the inhibition of task-irrelevant information processing-was observed in response to distractors later (538-757 ms) in the testosterone session than in the placebo session. These results suggest that testosterone facilitated phasic arousal to novel distractors during the early-latency stage, which might have influenced behavioral performance during the task. Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task. Our findings highlight the role of testosterone in distractor processing, and provide a theoretical basis for treating attention-related behavioral disorders with hormone therapies.",2020,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.",['34 healthy male volunteers'],"['placebo', 'testosterone', 'testosterone or placebo']",['temporal dynamics of distractor processing'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",34.0,0.311301,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.","[{'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China; Department of Psychology, University of Mannheim, Mannheim, Germany.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China. Electronic address: ww.peng0923@gmail.com.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104838']
1867,32871397,Neuromuscular training improves knee proprioception in athletes with a history of anterior cruciate ligament reconstruction: A randomized controlled trial.,"BACKGROUND


Athletes exhibit deficits in knee proprioception following anterior cruciate ligament reconstruction. Neuromuscular training programs improve knee proprioception in uninjured athletes; however, the effects on knee proprioception in athletes who have undergone anterior cruciate ligament reconstruction is not well understood. The purpose of this study was to examine the effects of a neuromuscular training program on knee proprioception in athletes who have returned to sport following anterior cruciate ligament reconstruction.
METHODS


Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12 months and returned to sport, participated in this randomized controlled trial. Athletes were randomly allocated to an experimental group (n = 12) that took part in an 8-week neuromuscular training program or a control group (n = 12) that simply continued their typical training routine. Knee position sense was assessed at baseline and after the 8-week period (post-testing). One-way analysis of covariance, with baseline performance included as a covariate, was used to compare knee position sense errors for the reconstructed limbs of the experimental and control groups at the post-testing time point.
FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period. As a result, the experimental group demonstrated lower knee position sense errors, compared to the control group, at the post-testing time point (P < .001).
INTERPRETATION


Athletes with a history of anterior cruciate ligament reconstruction may benefit from participation in a neuromuscular training program, even after completing post-operative rehabilitation.",2020,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","['athletes who have undergone anterior cruciate ligament reconstruction', 'Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12\xa0months and returned to sport', 'anterior cruciate ligament reconstruction', 'athletes who have returned to sport following anterior cruciate ligament reconstruction', 'athletes with a history of anterior cruciate ligament reconstruction', 'Athletes with a history of anterior cruciate ligament reconstruction', 'uninjured athletes']","['Neuromuscular training', 'neuromuscular training program', 'Neuromuscular training programs', 'neuromuscular training program or a control group (n\xa0=\xa012) that simply continued their typical training routine']","['lower knee position sense errors', 'knee proprioception', 'Knee position sense errors', 'Knee position sense']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",24.0,0.0152322,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghaderi', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Thomas Gus', 'Initials': 'TG', 'LastName': 'Almonroeder', 'Affiliation': 'University of Wisconsin - La Crosse, 1300 Badger St., La Crosse, WI 54601, United States. Electronic address: talmonroeder@uwlax.edu.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Velenjak St., Tehran 19857-17443, Iran.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105157']
1868,32891977,Social network heavy drinking moderates the effects of a brief motivational intervention for alcohol use among injured patients.,"BACKGROUND


Limited research has focused on identifying the extent to which social networks impact the effectiveness of brief alcohol interventions delivered in trauma care settings.
OBJECTIVES


The research presented here examines the extent to which the percent of heavy drinkers and percent of abstainers in one's social network moderates the effectiveness of a brief motivational intervention with and without a telephone booster on alcohol use among trauma patients.
METHOD


Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers. Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193). For the purpose of the present study, measures of alcohol-specific social network characteristics at baseline and alcohol use at 3- and 6-month follow-up were used.
RESULTS


At low percentages (0% to ~7%) of people in one's social network who are heavy drinkers, there was a negative, statistically significant effect of the BMI conditions versus the BA condition on alcohol use. However, percent of abstainers did not moderate the effects of the BMI conditions.
CONCLUSION


The results suggest that the BMI and BMI + B conditions may be most effective among patients with no heavy drinkers in their social networks. BMIs may benefit from including a component that addresses having one or more heavy drinkers in one's social network.",2020,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","['injured patients', 'trauma patients', 'Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers', 'patients with no heavy drinkers in their social networks']","['motivational intervention', 'motivational intervention with and without a telephone booster', 'brief advice (BA; n\xa0=\xa0200), brief motivational intervention (BMI; n\xa0=\xa0203), and BMI with a telephone booster (BMI\xa0+\xa0B; n\xa0=\xa0193']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C4319558', 'cui_str': '200'}]",[],596.0,0.015999,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","[{'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Alvarez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA. Electronic address: mjalvarez2@miners.utep.edu.'}, {'ForeName': 'Dylan K', 'Initials': 'DK', 'LastName': 'Richards', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Oviedo Ramirez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106594']
1869,32892129,Efficacy of Automatic Retention Pressure of a Double-Lumen Tube Cuff: An Artificial Intubation Model.,"BACKGROUND


The movement of a double-lumen endotracheal tube (DLT) out of its appropriate position during thoracic surgery can result in the loss of one-lung ventilation (OLV), especially during pulmonary resection and node dissection. Our study aimed to validate the efficacy of automatic retention pressure control of the DLT bronchial cuff in maintaining OLV in an artificial intubation model.
MATERIALS AND METHODS


A 35-Fr left-sided DLT was intubated to the left main bronchus in an intubation simulator and connected to an anesthesia machine. The inspiratory volume, respiratory rate, and inspiratory-expiratory ratio were set at 500 mL, 12 times/min, and 1:2, respectively. A 1-kg right main bronchial traction in the lateral right was provided after OLV was established. SmartCuff (Smiths Medical, Minneapolis, Minnesota, USA) was used to maintain cuff pressure. The efficacy of retention pressure with SmartCuff (Group S) and without SmartCuff (Group WS) was compared. The primary outcome was the rate of tidal volume (TV) reduction following bronchial traction in the two groups.
RESULTS


The TVs were 289.8 ± 28.9 mL and 242.8 ± 31.9 mL in Group S and Group WS, respectively (P = 0.003). The rate of TV reduction after bronchial traction was significantly lower in Group S (29 ± 5%) than in Group WS (43 ± 6%) (P < 0.001).
CONCLUSIONS


Automatic retention pressure control of the DLT bronchial cuff improves the rate of TV reduction during right main bronchial traction in an artificial intubation model. Continuous retention cuff pressure may be useful in maintaining OLV during thoracic surgery.",2020,"The rate of TV reduction after bronchial traction was significantly lower in Group S (29 ± 5%) than in Group WS (43 ± 6%) (P < 0.001).
",[],"['SmartCuff (Group S) and without SmartCuff (Group WS', 'Automatic Retention Pressure of a Double-Lumen Tube Cuff', 'automatic retention pressure control of the DLT bronchial cuff', 'SmartCuff ']","['rate of TV reduction', 'rate of TV reduction after bronchial traction', 'inspiratory volume, respiratory rate, and inspiratory-expiratory ratio', 'rate of tidal volume (TV) reduction following bronchial traction']",[],"[{'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0441110', 'cui_str': 'Tube cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]",,0.0364977,"The rate of TV reduction after bronchial traction was significantly lower in Group S (29 ± 5%) than in Group WS (43 ± 6%) (P < 0.001).
","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan. Electronic address: y_takahashi@sapmed.ac.jp.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tokinaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Michitaka', 'Initials': 'M', 'LastName': 'Edanaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tada', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Maki', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}]",The Journal of surgical research,['10.1016/j.jss.2020.08.017']
1870,32893313,Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial.,"PURPOSE


We hypothesized that neurally adjusted ventilatory assist (NAVA) compared to conventional lung-protective mechanical ventilation (MV) decreases duration of MV and mortality in patients with acute respiratory failure (ARF).
METHODS


We carried out a multicenter, randomized, controlled trial in patients with ARF from several etiologies. Intubated patients ventilated for ≤ 5 days expected to require MV for ≥ 72 h and able to breathe spontaneously were eligible for enrollment. Eligible patients were randomly assigned based on balanced treatment assignments with a computerized randomization allocation sequence to two ventilatory strategies: (1) lung-protective MV (control group), and (2) lung-protective MV with NAVA (NAVA group). Allocation concealment was maintained at all sites during the trial. Primary outcome was the number of ventilator-free days (VFDs) at 28 days. Secondary outcome was all-cause hospital mortality. All analyses were done according to the intention-to-treat principle.
RESULTS


Between March 2014 and October 2019, we enrolled 306 patients and randomly assigned 153 patients to the NAVA group and 153 to the control group. Median VFDs were higher in the NAVA than in the control group (22 vs. 18 days; between-group difference 4 days; 95% confidence interval [CI] 0 to 8 days; p = 0.016). At hospital discharge, 39 (25.5%) patients in the NAVA group and 47 (30.7%) patients in the control group had died (between-group difference - 5.2%, 95% CI - 15.2 to 4.8, p = 0.31). Other clinical, physiological or safety outcomes did not differ significantly between the trial groups.
CONCLUSION


NAVA decreased duration of MV although it did not improve survival in ventilated patients with ARF.",2020,"Other clinical, physiological or safety outcomes did not differ significantly between the trial groups.
","['patients with ARF from several etiologies', 'Eligible patients', '306 patients and randomly assigned 153 patients to the NAVA group and 153 to the control group', 'acute respiratory failure', 'patients with acute respiratory failure (ARF', 'ventilated patients with ARF', 'Intubated patients ventilated for\u2009≤\u20095\xa0days expected to require MV for\u2009≥\u200972\xa0h and able to breathe spontaneously were eligible for enrollment', 'Between March 2014 and October 2019']","['conventional lung-protective mechanical ventilation (MV', 'neurally adjusted ventilatory assist (NAVA', 'NAVA', 'Neurally adjusted ventilatory assist', 'computerized randomization allocation sequence to two ventilatory strategies: (1) lung-protective MV (control group), and (2) lung-protective MV with NAVA (NAVA group']","['MV and mortality', 'number of ventilator-free days (VFDs', 'duration of MV', 'cause hospital mortality', 'died', 'Median VFDs', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0566270', 'cui_str': 'Able to breathe'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",306.0,0.274373,"Other clinical, physiological or safety outcomes did not differ significantly between the trial groups.
","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Kacmarek', 'Affiliation': 'Department of Respiratory Care, Massachusetts General Hospital, 55 Fruit St, Warren 1225, Boston, MA, 01460, USA. rkacmarek@partners.org.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain. jesus.villar54@gmail.com.'}, {'ForeName': 'Dácil', 'Initials': 'D', 'LastName': 'Parrilla', 'Affiliation': 'Intensive Care Unit, Hospital Universitario N.S. de Candelaria, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alba', 'Affiliation': 'Intensive Care Unit, Hospital N.S. del Prado, Talavera de La Reina, Toledo, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Solano', 'Affiliation': 'Intensive Care Unit, Hospital Virgen de La Luz, Cuenca, Spain.'}, {'ForeName': 'Songqiao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Intensive Care Unit, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Montiel', 'Affiliation': 'Intensive Care Unit, Hospital Universitario N.S. de Candelaria, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Rico-Feijoo', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Río Hortega, Valladolid, Spain.'}, {'ForeName': 'Anxela', 'Initials': 'A', 'LastName': 'Vidal', 'Affiliation': 'Intensive Care Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrando', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Murcia', 'Affiliation': 'Intensive Care Unit, Complejo Universitario de Albacete, Albacete, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Corpas', 'Affiliation': 'Intensive Care Unit, Hospital N.S. del Prado, Talavera de La Reina, Toledo, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'González-Higueras', 'Affiliation': 'Intensive Care Unit, Hospital Virgen de La Luz, Cuenca, Spain.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Intensive Care Unit, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'César E', 'Initials': 'CE', 'LastName': 'Pinedo', 'Affiliation': 'Intensive Care Unit, Hospital Universitario N.S. de Candelaria, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pestaña', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Ramón Y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Martínez', 'Affiliation': 'Intensive Care Unit, Hospital Universitario Virgen de Arrixaca, Murcia, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Aldecoa', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Río Hortega, Valladolid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Añón', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Soro', 'Affiliation': 'Department of Anesthesia, Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Jesús M', 'Initials': 'JM', 'LastName': 'González-Martín', 'Affiliation': 'Biostatistics Division, Research Unit, Universitario Dr. Negrín, Las Palmas, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fernández', 'Affiliation': 'Research Unit, Hospital Universitario Dr. Negrín, Barranco de la Ballena s/n, 4th Floor South Wing, 35019, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Rosa L', 'Initials': 'RL', 'LastName': 'Fernández', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06181-5']
1871,32890808,Which one is favorable in the elderly? Transoral rigid laryngoscopy or transnasal flexible fiberoptic laryngoscopy.,"PURPOSE


To determine whether transoral rigid laryngeal endoscopy (TORLE) or transnasal flexible fiberoptic laryngoscopy (TNFFL) is more favorable for laryngeal endoscopic examination in the elderly population.
METHODS


This randomized prospective study carried out in a tertiary reference center. TORLE or TNFFL were performed to patients who were over 65 years at their first visit according to randomization list. At their second visit, other method was performed. Patients' physiological parameters (Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and oxygen (O 2 ) saturation before and immediately after laryngeal examination were recorded. Patients' pain-irritation, gag reflex, and dyspnea status were evaluated using visual analog scale after first and second endoscopic examinations. Further patient preferences for TORLE and TNFFL were recorded.
RESULTS


Of 96 patients included in the study, 69.8% (n = 67) preferred TORLE while 30.2% (n = 29) preferred TNFFL. Major factor influencing patient preferences was pain-irritation in TNFFL. Pain-irritation scores were significantly higher in TNFFL than those in TORLE (p < 0.001). However, no significant difference was found between two methods with respect to gag reflex and dyspnea scores (p = 0.194, p = 0.327, respectively). In TORLE, there was no statistically significant difference between the values measured before and after examination in terms of SBP, DBP, HR, and O 2  saturation (p = 0.641, p = 0.134, p = 0.119, p = 0.414, respectively). However, in TNFFL, statistically significant decrease was observed after examination in HR and O 2  saturation (p < 0.001, p < 0.001, respectively).
CONCLUSION


TORLE is more suitable for laryngeal examination in elderly patients since it is more comfortable for patient and does not change physiological parameters.",2020,Pain-irritation scores were significantly higher in TNFFL than those in TORLE (p < 0.001).,"['96 patients included in the study, 69.8% (n', 'elderly patients']","['TNFFL', 'transoral rigid laryngeal endoscopy (TORLE) or transnasal flexible fiberoptic laryngoscopy (TNFFL', 'TORLE or TNFFL', 'Transoral rigid laryngoscopy or transnasal flexible fiberoptic laryngoscopy', 'TORLE']","['visual analog scale', 'pain-irritation, gag reflex, and dyspnea status', 'Pain-irritation scores', 'gag reflex and dyspnea scores', 'examination in HR and O 2  saturation', 'SBP, DBP, HR, and O 2  saturation', 'physiological parameters (Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and oxygen (O 2 ) saturation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0702149', 'cui_str': 'Flexible fiberoptic laryngoscopy'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",96.0,0.0255202,Pain-irritation scores were significantly higher in TNFFL than those in TORLE (p < 0.001).,"[{'ForeName': 'Kamil Gokce', 'Initials': 'KG', 'LastName': 'Tulaci', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey. Electronic address: ktulaci@gmail.com.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Tulaci', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey.'}, {'ForeName': 'Hasmet', 'Initials': 'H', 'LastName': 'Yazici', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102660']
1872,32890814,Did young women in South African informal settlements display increased agency after participating in the Stepping Stones and Creating Futures intervention? A qualitative evaluation.,"This paper investigates the impact of the Stepping Stones Creating Futures (SSCF) intervention on young women in informal settlements in eThekwini, South Africa. Specifically, whether following participation in the intervention the young women experienced a reduction in intimate partner violence, strengthened agency and shifted gender relations. Where changes occurred, it examines how they occurred, and barriers and enablers to change. SSCF is a gender transformative and livelihoods strengthening intervention using participatory, reflective small groups. Qualitative research was undertaken with fifteen women participating in the SSCF randomised control trial between 2015 and 2018. The women were followed over 18 months, participating in in-depth interviews at baseline, 12- and 18-months post intervention. To supplement these, eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation. Data were analysed inductively. Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods. Despite these important shifts many women did not report a reduction in IPV. Nonetheless we argue most of the women, following the intervention, became more agentic. Drawing on the notion of 'distributed agency' as developed by Campbell and Mannell (2016), we show that SSCF bolstered the women's distributed agency. Distributed agency recognizes small agentic acts that women take, acts which to them are significant, it further notes that agency is temporal, fluid, dynamic and context specific. Women do not 'either have agency or not', rather being agentic depends on time, context and the particular incident. These findings provide an important contribution to the limited application of distributed agency and femininities work in informal settlements and are critical for policy and intervention science to reduce IPV and support women's agency.",2020,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","['young women in informal settlements in eThekwini, South Africa', 'fifteen women participating in the SSCF randomised control trial between 2015 and 2018', 'eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation']","['SSCF', 'Stepping Stones Creating Futures (SSCF) intervention']","['communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods', 'intimate partner violence, strengthened agency and shifted gender relations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0558038', 'cui_str': 'Participant observation'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0233894', 'cui_str': 'Femininity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0242360', 'cui_str': 'Relations, Gender'}]",15.0,0.0551815,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa. Electronic address: Samantha.willan@mrc.ac.za.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa; Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Nwabisa', 'Initials': 'N', 'LastName': 'Shai', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Nolwazi', 'Initials': 'N', 'LastName': 'Ntini', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113302']
1873,32890855,Reading proficiency influences the effects of transcranial direct current stimulation: Evidence from selective modulation of dorsal and ventral pathways of reading in bilinguals.,"INTRODUCTION


tDCS can modulate reading which is processed by lexical (ventral) and sub-lexical (dorsal) pathways. Previous research indicates that pathway recruitment in bilinguals depends on a script's orthographic depth and a reader's proficiency with it. The effect of tDCS on each reading pathway has not been investigated in bilinguals. We stimulated the left dorsal and ventral pathways separately in Chinese-English (C-E) bilinguals to understand whether pathway-specific modulation by tDCS is possible and, if so, how it is influenced by orthographic depth and script proficiency.
METHODS


A double-blind, sham-controlled, within-subject experiment was designed wherein 16 balanced bilinguals received anodal tDCS in dorsal, ventral and sham sessions. Two tDCS montages of electrode sizes 5 × 5 cm 2  with 1) anode at CP5 and cathode at CZ, and 2) anode at TP7 and cathode at nape of the neck, were applied for stimulating the dorsal and ventral pathways respectively. Bilinguals were asked to read word lists for each language before and after stimulation. RTs for accurate trials were analysed using linear mixed-effect modelling that included proficiency scores for reading English pseudo-words (PW) and Chinese pinyin.
RESULTS


For both languages, word reading RTs were faster following dorsal pathway stimulation. The dorsal stimulation effect (change in RT) was negatively correlated with pseudoword reading and pinyin proficiency. Stimulation of the ventral pathway decreased RTs only for Chinese reading.
CONCLUSION


Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading. Dorsal pathway tDCS effects are modulated by sub-lexical reading proficiency.",2020,Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading.,[],"['anodal tDCS', 'tDCS']",['dorsal stimulation effect (change in RT'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0476543,Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading.,"[{'ForeName': 'Sagarika', 'Initials': 'S', 'LastName': 'Bhattacharjee', 'Affiliation': 'Psychology, School of Social Sciences, Nanyang Technological University, Singapore.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Kashyap', 'Affiliation': 'Centre for Research and Development in Learning (CRADLE), Singapore.'}, {'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': ""O'Brien"", 'Affiliation': 'Centre for Research in Child Development (CRCD), National Institute of Education, Singapore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCloskey', 'Affiliation': 'Cognitive Science, Johns Hopkins University, Baltimore, United States.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Oishi', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, United States.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Desmond', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Rapp', 'Affiliation': 'Cognitive Science, Johns Hopkins University, Baltimore, United States. Electronic address: brapp1@jhu.edu.'}, {'ForeName': 'S H Annabel', 'Initials': 'SHA', 'LastName': 'Chen', 'Affiliation': 'Psychology, School of Social Sciences, Nanyang Technological University, Singapore; Centre for Research and Development in Learning (CRADLE), Singapore; Lee Kong Chian School of Medicine (LKC Medicine), Nanyang Technological University, Singapore. Electronic address: annabelchen@ntu.edu.sg.'}]",Brain and language,['10.1016/j.bandl.2020.104850']
1874,32890862,Implementing a transdiagnostic sleep and circadian intervention in a community mental health setting: A qualitative process evaluation with community stakeholders.,"The implementation of evidence-based psychological treatments (EBPTs) may be particularly challenging to accomplish in community mental health settings for individuals with severe mental illness (SMI). Transdiagnostic treatments, or treatments that target a mechanism that underpins multiple mental health problems, may be particularly well-suited to community mental health settings. This study examines community stakeholder perspectives (N = 22) of the Transdiagnostic Sleep and Circadian Intervention (TranS-C) implemented in a community mental health setting in the context of a randomized controlled trial of TranS-C for SMI. The present study aimed to identify barriers and facilitators to the implementation of TranS-C for SMI in a community mental health setting using (1) a deductive theory-based process based on the Framework for Dissemination in Health Services Intervention Research and (2) an inductive thematic analysis process. All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting. Seven additional themes were identified through the inductive thematic analysis. A discussion of how the findings are related to prior research, other EBPT implementation, and future TranS-C implementation are included.",2020,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,['individuals with severe mental illness (SMI'],"['Transdiagnostic Sleep and Circadian Intervention (TranS-C', 'transdiagnostic sleep and circadian intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0372757,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,"[{'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Gumport', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States; Department of Psychology, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States. Electronic address: aharvey@berkeley.edu.'}]",Psychiatry research,['10.1016/j.psychres.2020.113443']
1875,32868483,Analgesic efficacy of adding the IPACK block to a multimodal analgesia protocol for primary total knee arthroplasty.,"BACKGROUND AND OBJECTIVES


Peripheral nerve blocks have been integrated into most multimodal analgesia protocols for total knee arthroplasty (TKA). The adductor canal block (ACB) has gained popularity because of its quadriceps muscle sparing. Similarly, local anesthetic injection between the popliteal artery and the posterior capsule of the knee, IPACK block, has been described to provide analgesia to the posterior capsule of the knee with motor-sparing qualities. This prospective randomized controlled trial aimed to assess the analgesic efficacy of adding the IPACK block to our current multimodal analgesic regimen, including the ACB, in patients undergoing primary TKA.
METHODS


119 patients were randomized to receive either an IPACK or a sham block in addition to multimodal analgesia and an ACB. We were set to assess pain in the back of the knee 6 hours after surgery. Other end points included quality of recovery after surgery, pain scores, opioid requirements, and functional measures.
RESULTS


Patients who received the IPACK block had less pain in the back of the knee 6 hours after surgery when compared with the sham block: 21.7% vs 45.8%, p<0.01. There was marginal improvement in other pain measures in the first 24 hours after surgery. However, opioid requirements, quality of recovery and functional measures were similar between the two groups.
CONCLUSION


The IPACK block reduced the incidence of posterior knee pain 6 hours postoperatively.",2020,"However, opioid requirements, quality of recovery and functional measures were similar between the two groups.
","['total knee arthroplasty (TKA', '119 patients', 'patients undergoing primary TKA', 'primary total knee arthroplasty']","['IPACK or a sham block in addition to multimodal analgesia and an ACB', 'IPACK block', 'adductor canal block (ACB']","['posterior knee pain', 'quality of recovery after surgery, pain scores, opioid requirements, and functional measures', 'pain measures', 'Analgesic efficacy', 'analgesic efficacy', 'quality of recovery and functional measures', 'pain']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",119.0,0.178948,"However, opioid requirements, quality of recovery and functional measures were similar between the two groups.
","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Ochroch', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Badiola', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Taras', 'Initials': 'T', 'LastName': 'Grosh', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Graff', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Nelson', 'Affiliation': 'Department of Orthopedic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Israelite', 'Affiliation': 'Department of Orthopedic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nabil M', 'Initials': 'NM', 'LastName': 'Elkassabany', 'Affiliation': 'Department of Anesthesiology and Critical Care, University of Pennsylvania, Philadelphia, Pennsylvania, USA nabil.elkassabany@uphs.upenn.edu.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101558']
1876,32869399,A randomized trial of oral immunotherapy for pediatric cow's milk-induced anaphylaxis: Heated vs unheated milk.,"BACKGROUND


Severe reactions may develop during cow's milk (CM) oral immunotherapy (OIT). We investigated the safety and efficacy of low-dose OIT with heated milk (HM) or unheated milk (UM) in children with anaphylaxis.
METHODS


Children with symptom onset after ingestion of 3-mL HM on a double-blind, placebo-controlled food challenge were randomly assigned to the HM (n = 17) or UM (n = 16) group. HM group ingested milk powder heated at 125°C for 30 seconds, whereas the UM group used UM. Patients were hospitalized for 5 days; the HM or UM was gradually increased to 3 mL/day; 3-mL/day ingestion was continued at home. One year later, the patients underwent 2-day consecutive 3- and 25-mL HM-oral food challenges (OFCs) after 2-week avoidance.
RESULTS


At baseline, milk- and casein-specific immunoglobulin E (IgE) levels were 56.0 and 51.4 kUA/L in the HM group, and 55.2 and 65.6 kUA/L in the UM group, respectively. One year later, 35% and 18% in the HM group and 50% and 31% in UM group passed the 3 and 25 mL OFCs, respectively. Rates of moderate or severe symptoms and respiratory symptoms per home dose were significantly lower in the HM than in the UM group (0.7% and 1.2% vs 1.4% and 2.6%, respectively, P < .001). β-lactoglobulin-specific IgG 4  levels significantly increased from baseline only in the UM group, whereas casein-specific IgG 4  levels significantly increased from baseline in both groups.
CONCLUSIONS


HM-OIT induced immunological changes more safely than the UM-OIT. The possibility of lower treatment efficacy with HM-OIT needs to be evaluated in larger studies.",2020,"Rates of moderate or severe symptoms and respiratory symptoms per home dose were significantly lower in the HM than in the UM group (0.7% and 1.2% vs 1.4% and 2.6%, respectively, p <0.001).","[""pediatric cow's milk-induced anaphylaxis"", 'children with anaphylaxis', 'Children with symptom onset after ingestion of 3-mL HM on a double-blind, placebo-controlled food challenge']","['low-dose OIT with heated-milk (HM) or unheated-milk (UM', 'HM', 'oral immunotherapy', 'UM']","['casein-specific IgG4 levels', 'safety and efficacy', 'milk- and casein-specific immunoglobulin E (IgE) levels', 'β-lactoglobulin-specific IgG4 levels', 'HM or UM', 'Rates of moderate or severe symptoms and respiratory symptoms per home dose']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020860', 'cui_str': 'Immunoglobulin IgG4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1270793', 'cui_str': 'Casein specific immunoglobulin E'}, {'cui': 'C0022945', 'cui_str': 'Lactoglobulins'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.0690652,"Rates of moderate or severe symptoms and respiratory symptoms per home dose were significantly lower in the HM than in the UM group (0.7% and 1.2% vs 1.4% and 2.6%, respectively, p <0.001).","[{'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Nagakura', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Sakura', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Miura', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishino', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Asaumi', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Kiyotake', 'Initials': 'K', 'LastName': 'Ogura', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Ebisawa', 'Affiliation': 'Department of Pediatrics, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Yanagida', 'Affiliation': 'Department of Pediatrics, National Hospital Organization Sagamihara National Hospital, Kanagawa, Japan.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13352']
1877,32869451,"Short-term intestinal lipase inhibition in normal-weight individuals does not affect postprandial peptide YY 3-36  and glucagon-like peptide-1 levels, hunger or satiety.","Fat malabsorption associated with Roux-en-Y gastric bypass (RYGB) may contribute to elevated postprandial glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) after the procedure, leading to sustained weight loss and appetite reduction. This study investigated whether fat malabsorption via orlistat increases GLP-1 and PYY and if these increases would be proportional to changes in hunger and satiety. Five healthy participants received standardized meals with 120 mg orlistat or placebo in a randomized, double-blinded, crossover design for 3 days. On the final day, glucose, insulin, GLP-1, PYY 3-36  and visual analogue scores for hunger and satiety were measured over a 14-hour period that included three meals. Fasting, 14-hour area under the curve (AUC) and meal-related AUC for glucose and insulin were similar, although postprandial increases in peak insulin and glucose were greater with orlistat. PYY 3-36  , GLP-1, hunger and satiety were not different. In conclusion, short-term orlistat administration does not enhance postprandial GLP-1 or PYY 3-36  or affect hunger or satiety in normal-weight individuals. Furthermore, fat malabsorption from RYGB is unlikely to mediate subsequent postprandial increases in GLP-1 and PYY.",2020,"On the final day, glucose, insulin, GLP-1, PYY 3-36  , and visual analog scores for hunger and satiety were measured over a 14-hour period that included three meals.","['Five healthy participants received', 'normal weight individuals']","['Roux-en-Y gastric bypass (RYGB', 'standardized meals with 120 mg orlistat or placebo']","['glucose, insulin, GLP-1, PYY 3-36  , and visual analog scores for hunger and satiety', 'Fasting, 14-hour area under the curve (AUC), and meal-related AUC for glucose and insulin', 'Fat malabsorption', 'GLP-1, hunger, and satiety', 'peak insulin and glucose', 'GLP-1 levels, hunger, or satiety', 'hunger or satiety']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0076275', 'cui_str': 'orlistat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070359', 'cui_str': 'peptide YY (3-36)'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0554103', 'cui_str': 'Intestinal malabsorption of fat'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",5.0,0.0738729,"On the final day, glucose, insulin, GLP-1, PYY 3-36  , and visual analog scores for hunger and satiety were measured over a 14-hour period that included three meals.","[{'ForeName': 'Nga N', 'Initials': 'NN', 'LastName': 'Nguyen', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Kolobova', 'Affiliation': 'Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Wolfe', 'Affiliation': 'Department of Surgery, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Purnell', 'Affiliation': 'Knight Cardiovascular Institute, Oregon Health & Science University, Portland, Oregon, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14182']
1878,32871616,Preoperative intravenous iron therapy and survival after colorectal cancer surgery: long-term results from the IVICA randomised controlled trial.,"AIM


Preoperative iron is frequently used for the correction of anaemia in colorectal cancer surgery. However, enteral iron intake may promote tumour growth and progression which could influence cancer recurrence and patient survival. We explore the long-term outcomes of patients receiving either oral or intravenous iron replacement therapy as part of a previous randomized controlled trial.
METHODS


The IVICA trial randomized anaemic colorectal cancer patients to receive either oral (OI, control) or intravenous (IVI, treatment) iron prior to their elective operation. Follow-up analysis of all patients recruited to this multicentre trial who underwent surgical resection with curative intent was performed. Kaplan-Meier survival estimates and Cox proportional hazard models were used to compare groups. A pooled group multivariable analysis comparing patients who achieved resolution of anaemia preoperatively to those who did not was also undertaken.
RESULTS


In all, 110 of the 116 patients previously enrolled were eligible for analysis (OI n = 56, IVI n = 54). Median overall follow-up duration was 61 months (interquartile range 46-67). No significant difference in 5-year overall survival (hazard ratio (HR) 1.22, 95% CI 0.65-2.28, P = 0.522) or disease-free survival (HR 1.08, 95% CI 0.61-1.92, P = 0.79) was observed between OI and IVI. A pooled analysis of treatment groups found that preoperative resolution of anaemia led to improved 5-year overall survival on multivariable analysis (HR 3.38, 95% CI 1.07-11.56, P = 0.044).
CONCLUSION


We recommend IVI for the preoperative correction of anaemia. Route of iron therapy did not significantly influence survival. Preoperative anaemia correction may lead to an overall survival advantage following elective colorectal cancer surgery.",2020,"No significant difference in 5-year overall survival (HR 1.22, 95% CI 0.65-2.28 P=0.522) or disease free survival (HR 1.08, 95% CI 0.61-1.92 P=0.79) was observed between OI and IVI.","['110 of the 116 patients previously enrolled were eligible for analysis (OI n=56, IVI n=54', 'colorectal cancer surgery', 'anaemic colorectal cancer patients', 'Colorectal Cancer Surgery', 'elective colorectal cancer surgery', 'patients receiving either']","['oral (OI, control) or intravenous (IVI, treatment) iron prior to their elective operation', 'surgical resection with curative intent', 'oral or intravenous iron replacement therapy']","['5-year overall survival', 'preoperative resolution of anaemia', 'disease free survival', 'cancer recurrence and patient survival', 'survival', 'overall survival advantage']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1621368', 'cui_str': 'Drip Infusions'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1621368', 'cui_str': 'Drip Infusions'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0919650', 'cui_str': 'Iron replacement'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",116.0,0.440852,"No significant difference in 5-year overall survival (HR 1.22, 95% CI 0.65-2.28 P=0.522) or disease free survival (HR 1.08, 95% CI 0.61-1.92 P=0.79) was observed between OI and IVI.","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Dickson', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre in Gastrointestinal and Liver Diseases, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'B D', 'Initials': 'BD', 'LastName': 'Keeler', 'Affiliation': 'Milton Keynes University Hospitals NHS Foundation Trust, Milton Keynes, UK.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Ng', 'Affiliation': 'Department of Colorectal Surgery, Nottingham University Hospitals NHS Trust, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Gastroenterology, Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Brookes', 'Affiliation': 'Department of Gastroenterology, Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Acheson', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre in Gastrointestinal and Liver Diseases, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15342']
1879,32871327,"Comparison of optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention: Rationale and design of a randomized, controlled OCTIVUS trial.","BACKGROUND


The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is well acknowledged. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the most commonly used intravascular imaging to guide and optimize PCI in day-to-day practice. However, the comparative effectiveness of IVUS-guided versus OCT-guided PCI with respect to clinical end points remains unknown.
METHODS AND DESIGN


The OCTIVUS study is a prospective, multicenter, open-label, parallel-arm, randomized trial comparing the effectiveness of 2 imaging-guided strategies in patients with stable angina or acute coronary syndromes undergoing PCI in Korea. A total of 2,000 patients are randomly assigned in a 1:1 ratio to either an OCT-guided PCI strategy or an IVUS-guided PCI strategy. The trial uses a pragmatic comparative effectiveness design with inclusion criteria designed to capture a broad range of real-world patients with diverse clinical and anatomical features. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year.
RESULTS


Up to the end of July 2020, approximately 1,200 ""real-world"" PCI patients have been randomly enrolled over 2 years. Enrollment is expected to be completed around the midterm of 2021, and primary results will be available by late 2022 or early 2023.
CONCLUSION


This large-scale, multicenter, pragmatic-design clinical trial will provide valuable clinical evidence on the relative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI in the daily clinical practice.",2020,"The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year.
","['patients undergoing PCI in the daily clinical practice', 'patients with diverse clinical and anatomical features', 'patients with stable angina or acute coronary syndromes undergoing PCI in Korea', 'A total of 2,000 patients']","['OCT-guided PCI strategy or an IVUS-guided PCI strategy', '2 imaging-guided strategies', 'OCT-guided versus IVUS-guided PCI strategies', 'IVUS-guided versus OCT-guided PCI', 'Intravascular ultrasound (IVUS) and optical coherence tomography (OCT', 'optical coherence tomography-guided versus intravascular ultrasound-guided percutaneous coronary intervention']","['target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",,0.142284,"The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year.
","[{'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hanbit', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Soo-Jin', 'Initials': 'SJ', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Whan', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Hak', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seong-Wook', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Yun-Kyeong', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Cheol Hyun', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Young Joon', 'Initials': 'YJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Chonnam National University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Young Won', 'Initials': 'YW', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Soo-Joong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Kyunghee University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jang-Ho', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Department of Cardiology, Konyang University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Jun-Hyok', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Cardiology, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: dwpark@amc.seoul.kr.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: sjpark@amc.seoul.kr.'}]",American heart journal,['10.1016/j.ahj.2020.08.003']
1880,32880343,"Comparison of praziquantel efficacy at 40 mg/kg and 60 mg/kg in treating Schistosoma haematobium infection among schoolchildren in the Ingwavuma area, KwaZulu-Natal, South Africa.","BACKGROUND


The World Health Organization recommends praziquantel (PZQ) (40 mg/kg body weight) for treating schistosomiasis. However, drug failure has been reported, prompting use of 60 mg/kg, for which results have been inconsistent.
OBJECTIVES


To compare the efficacy of PZQ 40 mg/kg and 60 mg/kg in treating schoolchildren infected with Schistosoma haematobium.
METHODS


The study was conducted during November 2017 - August 2018 in the Ingwavuma area, uMkhanyakude District, KwaZulu-Natal Province, South Africa. Children aged 10 - 15 years were screened for S. haematobium using a filtration technique. Infected children were randomly assigned to a dose of PZQ of 40 mg/kg or 60 mg/kg. Side-effects were recorded within 24 hours after treatment using questionnaires and direct observation. Four weeks after treatment, participants were retested for S. haematobium infection. Baseline and post-treatment mean egg counts were calculated. Cure rate (CR) and egg reduction rate (ERR) were used to determine PZQ efficacy, while repeated-measures analysis of variance determined the effect of both doses on infection intensity. A χ2 test was used to determine the association of side-effects with treatment, with a p-value ≤0.05.
RESULTS


Forty-three and 36 children were treated with PZQ 40 mg/kg and 60 mg/kg, respectively. The 40 mg/kg group had a CR of 79.0% and an ERR of 97.2%, and the 60 mg/kg group a CR of 83.0% and an ERR of 98.3%. The effect of dose on infection intensity was not significantly different between the two groups (p&gt;0.05). Abdominal pains, dizziness and fatigue were common among children who received PZQ 40 mg/kg, while headache, dizziness and nausea were common in the 60 mg/kg group.
CONCLUSIONS


The efficacy of PZQ at 60 mg/kg was similar to that at 40 mg/kg. A dose &gt;40 mg/kg therefore does not add value in treating S. haematobium infection. Transient side-effects (mostly dizziness) were observed more in the 60 mg/kg group than in the 40 mg/kg group. We recommend continued use of 40 mg/kg body weight for treating schistosomiasis.",2020,The effect of dose on infection intensity was not significantly different between the two groups (p&gt;0.05).,"['Infected children', 'Children aged 10 - 15 years', 'schoolchildren in the Ingwavuma area, KwaZulu-Natal, South Africa', 'Forty-three and 36 children', 'November 2017 - August 2018 in the Ingwavuma area, uMkhanyakude District, KwaZulu-Natal Province, South Africa', 'schoolchildren infected with Schistosoma haematobium']","['PZQ', 'praziquantel (PZQ']","['Abdominal pains, dizziness and fatigue', 'headache, dizziness and nausea', 'Transient side-effects (mostly dizziness', 'Cure rate (CR) and egg reduction rate (ERR', 'infection intensity', 'Side-effects']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0036316', 'cui_str': 'Schistosoma haematobium'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.226608,The effect of dose on infection intensity was not significantly different between the two groups (p&gt;0.05).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kabuyaya', 'Affiliation': 'Discipline of Public Health Medicine, School of Nursing and Public Health, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa. muhubirikabuyaya@gmail.com.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Chimbari', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mukaratirwa', 'Affiliation': ''}]",South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde,['10.7196/SAMJ.2020.v110i7.13926']
1881,32881403,Waist Circumference Change During Intensive Lifestyle Intervention and Cardiovascular Morbidity and Mortality in the Look AHEAD Trial.,"OBJECTIVE


The Action for Health in Diabetes (Look AHEAD) trial was a randomized trial comparing effects of intensive lifestyle intervention (ILI) and diabetes support and education (DSE) on cardiovascular disease (CVD) among individuals with overweight/obesity and type 2 diabetes. A secondary analysis was conducted to evaluate the association between change in weight and waist circumference (WC) and CVD outcomes.
METHODS


Participants (N = 5,490) were classified into four categories based on change in weight and WC between baseline and year 1 (both increased, both decreased, etc.). Separate Cox proportional hazards regression models were fit for ILI and DSE (using group that reduced weight/WC as reference), and time to first occurrence of primary and secondary CVD outcomes from year 1 through a median of almost 10 years were compared. Second, time to first event among all four ILI groups relative to DSE was evaluated.
RESULTS


Within DSE, CVD outcomes did not differ. ILI participants with increased WC had increased risk of primary outcomes, regardless of weight loss (hazard ratio: 1.55 [95% CI: 1.11-2.17]) or weight gain (hazard ratio: 1.76 [95% CI: 1.07-2.89]), and had increased risk of secondary outcomes (overall P < 0.01) relative to ILI participants who reduced both weight and WC and relative to DSE participants.
CONCLUSIONS


In this secondary analysis, increased WC during the first year of ILI, independent of weight change, was associated with higher risk for subsequent cardiovascular outcomes.",2020,"ILI participants with increased WC had increased risk of primary outcomes, regardless of weight loss (hazard ratio: 1.55 [95% CI: 1.11-2.17]) or weight gain (hazard ratio: 1.76 [95% CI: 1.07-2.89]), and had increased risk of secondary outcomes (overall P < 0.01) relative to ILI participants who reduced both weight and WC and relative to DSE participants.
","['Participants (N\u2009=\u20095,490', 'Diabetes', 'individuals with overweight/obesity and type 2 diabetes']",['intensive lifestyle intervention (ILI) and diabetes support and education (DSE'],"['weight loss', 'weight gain', 'weight and waist circumference (WC) and CVD outcomes', 'Waist Circumference Change', 'cardiovascular disease (CVD']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",5490.0,0.140174,"ILI participants with increased WC had increased risk of primary outcomes, regardless of weight loss (hazard ratio: 1.55 [95% CI: 1.11-2.17]) or weight gain (hazard ratio: 1.76 [95% CI: 1.07-2.89]), and had increased risk of secondary outcomes (overall P < 0.01) relative to ILI participants who reduced both weight and WC and relative to DSE participants.
","[{'ForeName': 'KayLoni L', 'Initials': 'KL', 'LastName': 'Olson', 'Affiliation': 'Warren Alpert Medical School, Brown University, The Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Department of Medicine, New York Obesity Research Center, New York, New York, USA.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Staiano', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Wagenknecht', 'Affiliation': 'Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Warren Alpert Medical School, Brown University, The Miriam Hospital, Providence, Rhode Island, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22942']
1882,32877795,Recurrence patterns after neoadjuvant chemoradiotherapy compared with surgery alone in oesophageal squamous cell carcinoma: results from the multicenter phase III trial NEOCRTEC5010.,"BACKGROUND


The aim of this study was to compare recurrence patterns and prognostic factors for developing recurrences in patients with oesophageal squamous cell carcinoma (ESCC) who received neoadjuvant chemoradiotherapy (CRT) followed by surgery or surgery alone from a multicenter phase III trial NEOCRTEC5010.
PATIENTS AND METHODS


Patients with locally advanced ESCC were randomly assigned in a 1:1 ratio to receive neoadjuvant CRT plus surgery (CRT + S group) or surgery alone (S group). CRT consisted of two cycles of vinorelbine and cisplatin with concurrent radiotherapy of 40.0 Gy in 20 fractions. Recurrence patterns, sites, frequency, and timing and potential prognostic factors were compared.
RESULTS


Of the 451 patients enrolled from 2007 to 2014, 411 patients who underwent resection were analysed. After a median follow-up of 51.9 months, 62 patients (33.7%) in the CRT + S group versus 104 patients (45.8%) in the S group experienced recurrences (P = 0.013). The CRT + S group demonstrated a significantly better locoregional failure-free survival (P = 0.012) and a more favourable distant metastasis-free survival (P = 0.028) than the S group. Recurrences occurred earlier in the S group (P = 0.053), and late relapses were much more frequent in the CRT + S group (P = 0.029). On multivariate analysis, R1 resection and surgery alone were adverse factors for developing locoregional recurrences, whereas R1 resection was the only independent factor associated with distant metastases.
CONCLUSIONS


The neoadjuvant CRT regimen was associated with significantly reduced locoregional and distant recurrences compared with surgery alone. Recurrence patterns, sites and frequency were different between groups. TRIAL REGISTRATION CLINICALTRIALS.
GOV IDENTIFIER


NCT01216527.",2020,The CRT + S group demonstrated a significantly better locoregional failure-free survival (P = 0.012) and a more favourable distant metastasis-free survival (P = 0.028) than the S group.,"['patients with oesophageal squamous cell carcinoma (ESCC', '451 patients enrolled from 2007 to 2014, 411 patients who underwent resection were analysed', 'oesophageal squamous cell carcinoma', 'Patients with locally advanced ESCC']","['neoadjuvant chemoradiotherapy', 'vinorelbine and cisplatin with concurrent radiotherapy', 'neoadjuvant chemoradiotherapy (CRT) followed by surgery or surgery alone', 'surgery alone', 'neoadjuvant CRT plus surgery (CRT\xa0+\xa0S group) or surgery alone']","['favourable distant metastasis-free survival', 'locoregional failure-free survival', 'recurrences', 'Recurrences', 'Recurrence patterns, sites, frequency, and timing and potential prognostic factors', 'Recurrence patterns, sites\xa0and frequency', 'Recurrence patterns', 'late relapses', 'locoregional and distant recurrences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0443203', 'cui_str': 'Distant'}]",451.0,0.126553,The CRT + S group demonstrated a significantly better locoregional failure-free survival (P = 0.012) and a more favourable distant metastasis-free survival (P = 0.028) than the S group.,"[{'ForeName': 'Shiliang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Thoracic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Qiaoqiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Cancer Hospital of Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Chengchu', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Thoracic Surgery, Taizhou Hospital, Wenzhou Medical University, Linhai, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Zhentao', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Thoracic Surgery, Tianjin Medical University Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': 'Department of Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jiaqing', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yongtao', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Sichuan Cancer Hospital, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Mengzhong', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Thoracic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: fujh@sysucc.org.cn.'}, {'ForeName': 'Mian', 'Initials': 'M', 'LastName': 'Xi', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: ximian@sysucc.org.cn.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.002']
1883,32877825,Psychomotor Retardation and the prognosis of antidepressant treatment in patients with unipolar Psychotic Depression.,"BACKGROUND


Psychomotor Retardation is a key symptom of Major Depressive Disorder. According to the literature its presence may affect the prognosis of treatment. Aim of the present study is to investigate the prognostic role of Psychomotor Retardation in patients with unipolar Psychotic Depression who are under antidepressant treatment.
METHODS


The Salpetriere Retardation Rating Scale was administered at baseline and after 6 weeks to 122 patients with unipolar Psychotic Depression who were randomly allocated to treatment with imipramine, venlafaxine or venlafaxine plus quetiapine. We studied the effects of Psychomotor Retardation on both depression and psychosis related outcome measures.
RESULTS


73% of the patients had Psychomotor Retardation at baseline against 35% after six weeks of treatment. The presence of Psychomotor Retardation predicted lower depression remission rates in addition to a higher persistence of delusions. After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
CONCLUSIONS


Our data confirm that Psychomotor Retardation is a severity marker of unipolar Psychotic Depression. It is highly prevalent and predicts lower effectivity of antidepressant psychopharmacological treatment.",2020,"After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
","['patients with unipolar Psychotic Depression', 'patients with unipolar Psychotic Depression who are under antidepressant treatment', '122 patients with unipolar Psychotic Depression']","['imipramine', 'imipramine, venlafaxine or venlafaxine plus quetiapine', 'venlafaxine']","['depression remission rates', 'Salpetriere Retardation Rating Scale', 'Psychomotor Retardation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0020934', 'cui_str': 'Imipramine'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0025362', 'cui_str': 'Mental retardation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424230', 'cui_str': 'Motor retardation'}]",122.0,0.0264904,"After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
","[{'ForeName': 'Joost G E', 'Initials': 'JGE', 'LastName': 'Janzing', 'Affiliation': 'Department of Psychiatry, Department of Psychiatry, Radboudumc, Nijmegen, the Netherlands. Electronic address: Joost.Janzing@radboudumc.nl.'}, {'ForeName': 'Tom K', 'Initials': 'TK', 'LastName': 'Birkenhäger', 'Affiliation': 'Department of Psychiatry Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Walter W', 'Initials': 'WW', 'LastName': 'van den Broek', 'Affiliation': 'Department of Psychiatry Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Leonie M T', 'Initials': 'LMT', 'LastName': 'Breteler', 'Affiliation': 'Department of Psychiatry, St. Antonius-Mesos Hospital, Utrecht, the Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Nolen', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Robbert-Jan', 'Initials': 'RJ', 'LastName': 'Verkes', 'Affiliation': 'Department of Psychiatry, Department of Psychiatry, Radboudumc, Nijmegen, the Netherlands.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.020']
1884,32877859,The influence of center line width during the crossover hop test.,"OBJECTIVES


To assess the influence of center line width on crossover hop for distance test (XHOP) performance.
DESIGN


Repeated measures.
SETTING


University laboratory.
PARTICIPANTS


33 physically active females without history of a ligamentous knee injury (age: 22.5 ± 2.3 years).
MAIN OUTCOME MEASURES


Hop distance was measured during four XHOP conditions with variations in center line width: 2.54 cm (narrow), 15 cm (standard), 12.5% of the participants' height (HT1), and 25% of the participants' height (HT2). A repeated measures ANOVA was used to evaluate differences in hop distance for XHOP condition (narrow, standard, HT1, and HT2).
RESULTS


Differences in hop distance were shown on XHOP condition (p < 0.001). Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
CONCLUSIONS


No differences in hop distance were identified between narrow and standard center line width XHOP conditions in healthy females. Decreased hop distance was shown when center line width was normalized to 25% of participant height in comparison to all other XHOP conditions, with medium effect sizes. This study highlights hop distance outcomes based on different XHOP center line widths, normalizing the XHOP according to height, and potential implications for frontal plane knee loading during the XHOP in healthy individuals.",2020,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","['33 physically active females without history of a ligamentous knee injury (age: 22.5\xa0±\xa02.3 years', 'healthy females', 'University laboratory', 'healthy individuals']",[],"['distance test (XHOP) performance', 'XHOP condition', 'XHOP condition (narrow, standard, HT1, and HT2']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450565', 'cui_str': 'HT1'}, {'cui': 'C0450566', 'cui_str': 'HT2'}]",33.0,0.0332208,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","[{'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Ness', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA; Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave, Boston, MA, 02111, USA. Electronic address: Brandon.Ness@tufts.edu.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Albright', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ehlers', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Glasoe', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Selby', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kernozek', 'Affiliation': 'Department of Health Professions, Physical Therapy Program, La Crosse Institute for Movement Science, University of Wisconsin - La Crosse, 1725 State Street, La Crosse, WI, 54601, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.005']
1885,32877884,Reduced morbidity by using LigaSure compared to conventional inguinofemoral lymphadenectomy in vulvar cancer patients: A randomized controlled trial.,"BACKGROUND


Inguinofemoral lymphadenectomy (IFL) is part of the surgical treatment of different malignancies of the genital tract and/or the lower limb including vulvar carcinoma, penile carcinoma and melanoma. IFL is associated with morbidity in up to 85% of the patients. The aims of this MAMBO-IC study (Morbidity And Measurement of the Body) are to study the feasibility of using LigaSure for IFL and to assess the differences in the incidence of short-term complications using LigaSure versus conventional IFL randomized within each individual patient.
METHODS


In this multicenter randomized controlled trial (RCT), women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included. It was randomly assigned for which groin the LigaSure was used; the other groin was treated with conventional IFL (sharp/diathermia). We estimated the incidence of ≥1 complication(s) per groin using logistic regression and compared this between the two surgical methods, adjusting for possible confounders.
RESULTS


We included 40 groins of 20 patients. The estimated incidence of ≥1 complication(s) was 29% after LigaSure versus 70% after conventional IFL (risk difference 41% (95% CI 19-62), p < 0.001). Patients' reported restriction of daily living activities and maximum pain score were equal for both treatment methods. There were no differences in the surgeon reported workload scores.
CONCLUSIONS


This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL. Further studies with a larger sample size are needed to validate our findings. ISRCTN15057626.",2020,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"['40 groins of 20 patients', 'vulvar cancer patients', 'women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included']","['conventional IFL (sharp/diathermia', 'Inguinofemoral lymphadenectomy (IFL', 'IFL', 'conventional inguinofemoral lymphadenectomy', 'LigaSure']","['restriction of daily living activities and maximum pain score', 'morbidity', 'estimated incidence of ≥1 complication(s']","[{'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0280856', 'cui_str': 'Squamous cell carcinoma of vulva'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.247773,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"[{'ForeName': 'Anne-Floor W', 'Initials': 'AW', 'LastName': 'Pouwer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands. Electronic address: Anne-Floor.W.Pouwer@radboudumc.nl.'}, {'ForeName': 'Henriette J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, Department of Obstetrics and Gynaecology, the Netherlands.'}, {'ForeName': 'Corine M', 'Initials': 'CM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Johanna M A', 'Initials': 'JMA', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'de Hullu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.011']
1886,32883337,Implementation of strength-based case management for opioid-dependent patients presenting in medical emergency departments: rationale and study design of a randomized trial.,"BACKGROUND


As the USA grapples with an opioid epidemic, medical emergency departments (EDs) have become a critical setting for intervening with opioid-dependent patients. Brief interventions designed to bridge the gap from acute ED care to longer-term treatment have shown limited efficacy for this population. Strength-based case management (SBCM) has shown strong effects on treatment linkage among patients with substance use disorders in other healthcare settings. This study aimed to investigate whether SBCM is an effective model for linking opioid-dependent ED patients with addiction treatment and pharmacotherapy. Here, we describe the implementation and challenges of adapting SBCM for the ED (SBCM-ED). Study rationale, design, and baseline characteristics are also described.
METHODS


This study compared the effects of SBCM-ED to screening, assessment, and referral alone (SAR) on treatment linkage, substance use, and functioning. We recruited participants from a public hospital in NYC. Working alliance between case managers and participants and the feasibility of SBCM implementation were evaluated. Baseline data from the randomized sample were analyzed for group equivalency. Outcomes analyses are forthcoming.
RESULTS


Three hundred adult participants meeting DSM-IV criteria for opioid dependence were randomly assigned to either SBCM, in which they received a maximum of six case management sessions within 90 days of enrollment, or SAR, in which they received a comprehensive referral list and pamphlet outlining drug use consequences. No significant differences were found between groups at baseline on demographic or substance use characteristics. All SAR participants and 92.6% of SBCM-ED participants initiated their assigned intervention. Over half of SBCM-ED first sessions occurred in the ED on the day of enrollment. Case managers developed a strong working alliance with SBCM-ED participants after just one session.
CONCLUSION


Interventions that exceed SBIRT were accepted by an opioid-dependent patient population seen in an urban medical ED. At the time of study funding, this trial was one of the first to focus specifically on this population in this challenging setting. The successful implementation of SBCM demonstrates its adaptability to the ED and may serve as a potential model for EDs seeking to adopt an intervention that overcomes the barrier between the ED encounter and more intensive treatment.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02586896 . Registered on 27 October 2015.",2020,No significant differences were found between groups at baseline on demographic or substance use characteristics.,"['We recruited participants from a public hospital in NYC', 'Three hundred adult participants meeting DSM-IV criteria for opioid dependence', 'dependent patients presenting in medical emergency departments', 'patients with substance use disorders in other healthcare settings', 'ED patients with addiction treatment and pharmacotherapy']","['Strength-based case management (SBCM', 'comprehensive referral list and pamphlet outlining drug use consequences', 'strength-based case management for opioid', 'SBCM']",[],"[{'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0524662', 'cui_str': 'Opioid dependence'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0600661', 'cui_str': 'Outlines'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",[],300.0,0.0812963,No significant differences were found between groups at baseline on demographic or substance use characteristics.,"[{'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Regis', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Meyers-Ohki', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Mennenga', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Greco', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Glisker', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Kolaric', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'McCormack', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Rapp', 'Affiliation': 'Wright State University, Boonshoft School of Medicine, Dayton, OH, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bogenschutz', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA. Michael.Bogenschutz@nyulangone.org.'}]",Trials,['10.1186/s13063-020-04684-6']
1887,32884253,Early Clinically Important Improvement (ECII) and Exacerbation Outcomes in COPD Patients.,"Background


Chronic obstructive pulmonary disease (COPD) exacerbations are difficult outcomes to measure in clinical trials. It would be valuable to be able to predict which patients are likely to benefit in terms of exacerbation prevention based on their early response in lung function and symptoms.
Methods


This was a post-hoc analysis from the 52-week, randomized, double-blind, double-dummy, non-inferiority FLAME trial. Early clinically important improvement (ECII) was defined as achievement of minimal clinically important difference in trough forced expiratory volume in 1 second (FEV 1 ; ≥100 mL increase) and one patient-reported outcome (PRO): either St. George's Respiratory Questionnaire for COPD (≥4-unit reduction; D1), or COPD assessment test (≥2-point reduction; D2) at Week 4 or 12.
Results


Approximately 18-20% of patients achieved ECII at Week 4 or 12 post-randomization according to any of the two definitions. The rate of subsequent exacerbations was lower in patients who achieved ECII at Week 4 (D1: ratio of rates [95% CI], 0.85 [0.74 to 0.98]; D2, 0.88 [0.77 to 1.00]) or at Week 12 (D1, 0.85 [0.74 to 0.98]; D2, 0.86 [0.75 to 1.00]) versus patients not achieving ECII. Patients who achieved ECII experienced longer time-to-first exacerbation between Week 4 or 12 to end of study. More patients achieved ECII with indacaterol/glycopyrronium versus salmeterol/fluticasone according to both definitions at Week 4 (D1, odds ratio [95% CI], 1.69 [1.40 to 2.04]; D2, 1.61 [1.34 to 1.93]), and 12 (D1, 2.01 [1.66 to 2.44]; D2, 1.80 [1.48 to 2.18]).
Conclusion


ECII is a novel composite endpoint, based on clinically relevant improvement in lung function and PROs in the early phase of treatment intervention that may predict subsequent exacerbation risk and may be used in clinical trials.",2020,"More patients achieved ECII with indacaterol/glycopyrronium versus salmeterol/fluticasone according to both definitions at Week 4 (D1, odds ratio [95% CI], 1.69 [1.40 to 2.04]; D2, 1.61 [1.34 to 1.93]), and 12 (D1, 2.01","['COPD Patients', '\n\n\nChronic obstructive pulmonary disease (COPD) exacerbations']",['indacaterol/glycopyrronium versus salmeterol/fluticasone'],"[""outcome (PRO): either St. George's Respiratory Questionnaire for COPD (≥4-unit reduction; D1), or COPD assessment test"", 'ECII experienced longer time-to-first exacerbation', 'trough forced expiratory volume', 'rate of subsequent exacerbations']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",,0.250308,"More patients achieved ECII with indacaterol/glycopyrronium versus salmeterol/fluticasone according to both definitions at Week 4 (D1, odds ratio [95% CI], 1.69 [1.40 to 2.04]; D2, 1.61 [1.34 to 1.93]), and 12 (D1, 2.01","[{'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Kostikas', 'Affiliation': 'Respiratory Medicine Department, University of Ioannina Medical School, Ioannina, Greece.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Mackay', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Stefan-Marian', 'Initials': 'SM', 'LastName': 'Frent', 'Affiliation': 'Department of Pulmonology, University of Medicine and Pharmacy Timisoara, Timisoara, Romania.'}, {'ForeName': 'Pritam', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Banerji', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patalano', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pascal J', 'Initials': 'PJ', 'LastName': 'Pfister', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'Respiratory Clinical Science Section, National Heart and Lung Institute, Imperial College London, London, UK.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S247966']
1888,32897010,[The effectiveness of recombinant interferon alpha-2b in the treatment of chronic recurrent bacterial prostatitis].,"INTRODUCTION


Chronic recurrent bacterial prostatitis (HRBP) affects the reproductive function and negatively affects the quality of life of men. The multifactorial pathogenesis of this disease causes the failure of antibiotic therapy and some cases, requires an in-depth study of the mechanisms of disease development and additional treatment methods.
OBJECTIVES


of the study: to study of the effectiveness of immunoactive therapy (recombinant interferon alpha-2b with an antioxidant complex) in combination with antibacterial therapy in patients with HRBP.
MATERIALS AND METHODS


Prospective trial: examination and treatment of 62 patients. Two groups: I (study) group (n=31) received antibacterial therapy (ABT) and a therapy with recombinant IFN Alpha-2b based medication with antioxidant complex (vitamins E and C), II (control) group (n=31) received only ABT. The examination plan included questionnaires (NIH - CPSI, IPSS, Hamilton), general blood and urine tests, biochemical blood tests, urethral scrapings for PCR diagnostics, plasma testosterone, native, electron microscopy, culture test and immunoferment analysis of the prostate sercet, uroflowmetry, Transrectal ultrasonography (TRUS).
RESULTS


When monitoring the clinical picture according to questionnaires (IPSS, NIH-CPSI, Hamilton scale) and laboratory indicators, 1 month after treatment, a significant reduction in symptoms was observed in both groups, and after 3, 6, and 12 months - in patients of group I.
CONCLUSIONS


The Combination of an antibacterial drug and recombinant interferon alpha-2b in the treatment of HRBP provides more effective relief of the infectious and inflammatory process in the long term than antibacterial monotherapy.",2020,"When monitoring the clinical picture according to questionnaires (IPSS, NIH-CPSI, Hamilton scale) and laboratory indicators, 1 month after treatment, a significant reduction in symptoms was observed in both groups, and after 3, 6, and 12 months - in patients of group I.
CONCLUSIONS


The Combination of an antibacterial drug and recombinant interferon alpha-2b in the treatment of HRBP provides more effective relief of the infectious and inflammatory process in the long term than antibacterial monotherapy.","['Chronic recurrent bacterial prostatitis (HRBP', 'patients with HRBP', '62 patients', 'chronic recurrent bacterial prostatitis']","['immunoactive therapy (recombinant interferon alpha-2b with an antioxidant complex', 'antibacterial therapy (ABT) and a therapy with recombinant IFN Alpha-2b based medication with antioxidant complex (vitamins E and C), II (control) group (n=31) received only ABT', 'recombinant interferon alpha-2b']","['questionnaires (NIH - CPSI, IPSS, Hamilton), general blood and urine tests, biochemical blood tests, urethral scrapings for PCR diagnostics, plasma testosterone, native, electron microscopy, culture test and immunoferment analysis of the prostate sercet, uroflowmetry, Transrectal ultrasonography (TRUS']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0748023', 'cui_str': 'Bacterial prostatitis'}, {'cui': 'C0062748', 'cui_str': 'histidine rich basic peptide (Aplysia)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0444082', 'cui_str': 'Scrapings'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0857717', 'cui_str': 'Plasma testosterone'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}]",62.0,0.038075,"When monitoring the clinical picture according to questionnaires (IPSS, NIH-CPSI, Hamilton scale) and laboratory indicators, 1 month after treatment, a significant reduction in symptoms was observed in both groups, and after 3, 6, and 12 months - in patients of group I.
CONCLUSIONS


The Combination of an antibacterial drug and recombinant interferon alpha-2b in the treatment of HRBP provides more effective relief of the infectious and inflammatory process in the long term than antibacterial monotherapy.","[{'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Ibishev', 'Affiliation': 'Department of Urology and Human Reproductive Health, Rostov State Medical University, Ministry of Health of Russia, Rostov-on-don, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Mantsov', 'Affiliation': 'Department of Urology and Human Reproductive Health, Rostov State Medical University, Ministry of Health of Russia, Rostov-on-don, Russia.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Krainii', 'Affiliation': 'Department of Urology and Human Reproductive Health, Rostov State Medical University, Ministry of Health of Russia, Rostov-on-don, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
1889,32897568,Contralateral effects of eccentric resistance training on immobilized arm.,"This study compared the effects of contralateral eccentric-only (ECC) and concentric-/eccentric-coupled resistance training (CON-ECC) of the elbow flexors on immobilized arm. Thirty healthy participants (18-34 y) were randomly allocated to immobilization only (CTRL; n = 10), immobilization and ECC (n = 10), or immobilization and CON-ECC group (n = 10). The non-dominant arms of all participants were immobilized (8 h·day -1  ) for 4 weeks, during which ECC and CON-ECC were performed by the dominant (non-immobilized) arm 3 times a week (3-6 sets of 10 repetitions per session) with an 80%-120% and 60%-90% of one concentric repetition maximum (1-RM) load, respectively, matching the total training volume. Arm circumference, 1-RM and maximal voluntary isometric contraction (MVIC) strength, biceps brachii surface electromyogram amplitude (sEMG RMS  ), rate of force development (RFD), and joint position sense (JPS) were measured for both arms before and after immobilization. CTRL showed decreases (P < .05) in MVIC (-21.7%), sEMG RMS  (-35.2%), RFD (-26.0%), 1-RM (-14.4%), JPS (-87.4%), and arm circumference (-5.1%) of the immobilized arm. These deficits were attenuated or eliminated by ECC and CON-ECC, with greater effect sizes for ECC than CON-ECC in MVIC (0.29: +12.1%, vs -0.18: -0.1%) and sEMG RMS  (0.31:17.5% vs -0.15: -5.9%). For the trained arm, ECC showed greater effect size for MVIC than CON-ECC (0.47 vs 0.29), and increased arm circumference (+2.9%), sEMG RMS  (+77.9%), and RDF (+31.8%) greater (P < .05) than CON-ECC (+0.6%, +15.1%, and + 15.8%, respectively). The eccentric-only resistance training of the contralateral arm was more effective to counteract the negative immobilization effects than the concentric-eccentric training.",2020,"These deficits were attenuated or eliminated by ECC and CON-ECC, with greater effect sizes for ECC than CON-ECC in MVIC (0.29: +12.1%, vs -0.18:",['Thirty healthy participants (18-34 y'],"['contralateral eccentric-only (ECC) and concentric-eccentric coupled resistance training (CON-ECC', 'JPS', 'Eccentric Resistance Training', 'CTRL', 'immobilization and ECC (n=10) or immobilization and CON-ECC']","['Arm circumference, 1-RM and maximal voluntary isometric contraction strength (MVIC), biceps brachii surface electromyogram amplitude (sEMG RMS  ), rate of force development (RFD) and joint position sense (JPS', 'RFD', 'MVIC', '1-RM', 'RDF', 'sEMG RMS', 'arm circumference']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0345893', 'cui_str': 'Juvenile polyposis syndrome'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0345893', 'cui_str': 'Juvenile polyposis syndrome'}, {'cui': 'C2927794', 'cui_str': 'RFD'}]",30.0,0.0218477,"These deficits were attenuated or eliminated by ECC and CON-ECC, with greater effect sizes for ECC than CON-ECC in MVIC (0.29: +12.1%, vs -0.18:","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Valdes', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, Santiago, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ramirez', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, Santiago, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Perez', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, Santiago, Chile.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Garcia-Vicencio', 'Affiliation': 'Physiology of Exercise and Activities in Extreme Conditions Unit, Operational Environments Department, French Armed Forces Biomedical Research Institute (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Nosaka', 'Affiliation': 'Centre for Exercise and Sports Science Research, School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Penailillo', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, Santiago, Chile.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13821']
1890,32898787,"Calorie restriction and synbiotics effect on quality of life and edema reduction in breast cancer-related lymphedema, a clinical trial.","BACKGROUND


Little evidence exists regarding the clinical value of synbiotics in the management of post-treatment complications of breast cancer especially breast cancer-related lymphedema (BCRL). This study aimed to investigate the effects of synbiotic supplementation along with calorie restriction on quality of life and edema volume in patients with BCRL.
METHODS


This randomized, placebo-controlled, clinical trial was conducted on 135 overweight and obese women with BCRL aged 18-65 years old. Participants were randomly allocated to receive a calorie-restricted diet plus 10 9  CFU synbiotic supplement (CRS group; n = 45) or placebo (CRP group; n = 45), daily for 10 weeks. Also, a control group (n = 45) with no intervention was included in the trial. All of the participants received Complete Decongestive Therapy for lymphedema treatment. The quality of life score, edema volume and body mass index (BMI) were measured at baseline and end of the trial.
RESULTS


A total of 121 subjects completed the trial. CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control. However, there were no significant differences in changes in trial outcomes between the CRS and CRP groups.
CONCLUSION


Synbiotic supplementation along with a low-calorie diet was effective in quality of life, edema volume, and BMI improvement; mostly due to low-calorie diet. It seems that adding a dietitian consultation on the lymphedema management strategy may provide a better result in lymphedema control.",2020,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","['patients with BCRL', 'breast cancer-related lymphedema', '135 overweight and obese women with BCRL aged 18-65 years old', 'breast cancer especially breast cancer-related lymphedema (BCRL', '121 subjects completed the trial']","['synbiotic supplementation', 'CRS', 'Synbiotic supplementation', 'placebo', 'calorie-restricted diet plus 10 9 \xa0CFU synbiotic supplement (CRS group; n\xa0=\xa045) or placebo (CRP', 'calorie restriction', 'Complete Decongestive Therapy']","['BMI', 'quality of life, edema volume, and BMI improvement', 'quality of life and edema volume', 'edema volume', 'quality of life score, edema volume and body mass index (BMI', 'total quality of life score', 'quality of life and edema reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0474212', 'cui_str': 'Reduction of edema'}]",135.0,0.165473,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","[{'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: zarrati_ms@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Malakootinejad', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Saneei', 'Initials': 'AS', 'LastName': 'Totmaj', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Sanati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. Electronic address: sha_haghighat@yahoo.com.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.008']
1891,32898792,Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small cell lung cancer: IFCT-1201 MODEL trial.,"PURPOSE


Maintenance chemotherapy is a reasonable choice for patients with metastatic non-small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet. Nevertheless, there have been no studies dedicated to elderly patients.
PATIENTS AND METHODS


We conducted a randomised trial in patients aged 70-89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500 mg/m 2  d1, 22) in patients with non-squamous cell carcinoma or gemcitabine (1,150 mg/m 2  d1, 8, 22) in squamous cell carcinoma to simple observation. The patients were required to have a performance status (PS) 0-2, mini-mental score >23, and creatinine clearance ≥45 mL/min. The primary end-point was overall survival (OS).
RESULTS


632 patients were enrolled from May 2013 to October 2016. Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received pemetrexed and 43 gemcitabine. The median OS from randomisation was 14.1 months (95% confidence interval [CI]: 12.0-17.0) in the observation arm and 14 months (95% CI: 10.9-16.9) in the maintenance arm (p = 0.72). The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6-3.1) in the observation arm versus 5.7 months (95% CI: 4.8-7.1) in the maintenance arm (p < 0.001).
CONCLUSION


Switch maintenance therapy significantly prolonged PFS but not OS and, thus, should not be proposed to elderly patients with advanced NSCLC.",2020,"The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6-3.1) in the observation arm versus 5.7 months (95% CI: 4.8-7.1) in the maintenance arm (p < 0.001).
","['elderly patients with advanced non-small cell lung cancer', 'elderly patients', 'patients were required to have a performance status (PS) 0-2, mini-mental score >23, and creatinine clearance ≥45', 'patients aged 70-89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500\xa0mg/m 2  d1, 22) in patients with non-squamous cell carcinoma or', 'elderly patients with advanced NSCLC', '632 patients were enrolled from May 2013 to October 2016', 'patients with metastatic non-small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet', 'Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received']","['pemetrexed and 43 gemcitabine', 'Maintenance chemotherapy', 'gemcitabine', 'carboplatin and weekly paclitaxel doublet chemotherapy']","['median progression-free survival (PFS', 'median OS', 'overall survival (OS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1545484', 'cui_str': 'Non-squamous epithelial cell'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",632.0,0.168415,"The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6-3.1) in the observation arm versus 5.7 months (95% CI: 4.8-7.1) in the maintenance arm (p < 0.001).
","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Quoix', 'Affiliation': 'Department of Pneumology, University Hospital of Strasbourg, Strasbourg, France. Electronic address: equoix@gmail.com.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Department of Pneumology, Toulon Sainte-Musse Hospital, Toulon, France.'}, {'ForeName': 'Armelle', 'Initials': 'A', 'LastName': 'Lavolé', 'Affiliation': 'Department of Pneumology, Tenon Hospital, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Department of Pneumology, Hospital of Le Mans, Le Mans, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Westeel', 'Affiliation': 'Department of Pneumology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Le Treut', 'Affiliation': ""Department of Pneumology, Pays D'Aix Hospital, Aix-en-Provence, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pichon', 'Affiliation': 'Department of Pneumology, University Hospital of Tours, Tours, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Dauba', 'Affiliation': 'Department of Medical Oncology, Hospital Layné, Mont-de-Marsan, France.'}, {'ForeName': 'Josiane', 'Initials': 'J', 'LastName': 'Otto', 'Affiliation': ""University of Côte D'Azur, Nice, France.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Moreau', 'Affiliation': 'Department of Pneumology, Louis Pasteur Hospital, Colmar, France.'}, {'ForeName': 'Jeannick', 'Initials': 'J', 'LastName': 'Madelaine', 'Affiliation': 'Department of Pneumology, University Hospital of Caen Normandie, Caen, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dumont', 'Affiliation': 'Department of Pneumology, Hospital of Chauny, Chauny, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Margery', 'Affiliation': ""Department of Pneumology, Hôpital D'Instruction des Armées Percy, Clamart, France.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Debieuvre', 'Affiliation': 'Department of Pneumology, GHRMSA, Emile Miller Hospital, Mulhouse, France.'}, {'ForeName': 'Patrick Aldo', 'Initials': 'PA', 'LastName': 'Renault', 'Affiliation': 'Department of Pneumology, Hospital of Pau, Pau, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pujol', 'Affiliation': 'Department of Thoracic Oncology, Montpellier Regional University Hospital, Montpellier, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Langlais', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique, Paris, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique, Paris, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Thoracic Oncology Unit, Grenoble-Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Department of Pneumology and Thoracic Oncology, Hospital of Lyon Sud, Lyon, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.07.034']
1892,32898839,Pediatrics adverse childhood experiences and related life events screener (PEARLS) and health in a safety-net practice.,"BACKGROUND


Adverse Childhood Experiences (ACEs) are associated with behavioral, mental, and clinical outcomes in children. Tools that are easy to incorporate into pediatric practice, effectively screen for adversities, and identify children at high risk for poor outcomes are lacking.
OBJECTIVE


To examine the relationship between caregiver-reported child ACEs and related life events with health outcomes.
PARTICIPANTS AND SETTING


Participants (0-11 years) were recruited from the University of California San Francisco Benioff's Children Hospital Oakland Primary Care Clinic. There were 367 participants randomized.
METHODS


Participants were randomized 1:1:1 to item-level (item response), aggregate-level (total number of exposures), or no screening for ACEs (control arm) with the PEdiatric ACEs and Related Life Event Screener (PEARLS). We assessed 10 ACE categories capturing abuse, neglect, and household challenges, as well as 7 additional categories. Multivariable regression models were conducted.
RESULTS


Participants reported a median of 2 (IQR 1-5) adversities with 76 % (n = 279) reporting at least one adversity; participants in the aggregate-level screening arm, on average, disclosed 1 additional adversity compared to item-level screening (p = 0.01). Higher PEARLS scores were associated with poorer perceived child general health (adjusted B = -0.94, 95 %CI: -1.26, -0.62) and Global Executive Functioning (adjusted B = 1.99, 95 %CI: 1.51, 2.46), and greater odds of stomachaches (aOR 1.14; 95 %CI: 1.04-1.25) and asthma (aOR 1.08; 95 %CI 1.00, 1.17). Associations did not differ by screening arm.
CONCLUSION


In a high-risk pediatric population, ACEs and other childhood adversities remain an independent predictor of poor health. Increased efforts to screen and address early-life adversity are necessary.",2020,"Associations did not differ by screening arm.
","['children', 'Participants', '367 participants randomized', ""Participants (0-11 years) were recruited from the University of California San Francisco Benioff's Children Hospital Oakland Primary Care Clinic""]","['aggregate-level (total number of exposures), or no screening for ACEs (control arm) with the PEdiatric ACEs and Related Life Event Screener (PEARLS']","['child general health', 'Global Executive Functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]","[{'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0454267', 'cui_str': 'Number of exposures'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0557155', 'cui_str': 'Life event observable'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",367.0,0.182968,"Associations did not differ by screening arm.
","[{'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Thakur', 'Affiliation': 'University of California, San Francisco Departments of Medicine and Epidemiology and Biostatistics, 500 Parnassus Avenue, PO Box 0841, San Francisco CA, 94143-0841, United States. Electronic address: Neeta.Thakur@ucsf.edu.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'University of California, San Francisco Department of Family and Community Medicine, 500 Parnassus Avenue, E334, Box 0900, San Francisco, CA, 94117, United States. Electronic address: Danielle.Hessler@ucsf.edu.'}, {'ForeName': 'Kadiatou', 'Initials': 'K', 'LastName': 'Koita', 'Affiliation': 'Center for Youth Wellness, 3450 3rd St, San Francisco, CA, 94124, United States. Electronic address: kadiatoukoita1@gmail.com.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': 'University of California, San Francisco Department of Medicine. Electronic address: morganyafang.ye@ucsf.edu.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Benson', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, 747 52nd St, Oakland, CA, 94609, United States. Electronic address: Mindy.Benson@ucsf.edu.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Gilgoff', 'Affiliation': 'Center for Youth Wellness, 3450 3rd St, San Francisco, CA, 94124, United States. Electronic address: rgilgoff@centerforyouthwellness.org.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bucci', 'Affiliation': 'Center for Youth Wellness, 3450 3rd St, San Francisco, CA, 94124, United States. Electronic address: mbucci@centerforyouthwellness.org.'}, {'ForeName': 'Dayna', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, 747 52nd St, Oakland, CA, 94609, United States; California AB 340 Work Group Member, United States. Electronic address: dayna.long@ucsf.edu.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Burke Harris', 'Affiliation': 'Center for Youth Wellness, 3450 3rd St, San Francisco, CA, 94124, United States. Electronic address: nadine.burke@gmail.com.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104685']
1893,32899089,Short-term clinical efficacy of the pulsed Nd: YAG laser therapy on chronic nonspecific low back pain: A randomized controlled study.,"BACKGROUND


Chronic non-specific low back pain (LBP) is gradually increasing among populations worldwide and affects their activities. Recently, the Nd:YAG laser has been presented in the rehabilitation field.
OBJECTIVES


This study aims to explore the short-term effects of the Nd:YAG laser on chronic non-specific LBP individuals.
METHODS


Thirty-five individuals with chronic nonspecific LBP were included in the study from December 2019 to March 2020. Randomly, they were categorized to Nd:YAG group (n = 18) and sham laser as a control (n = 17) thrice weekly for a 6-week intervention. Modified Oswestry disability index (MODI), pain disability index (PDI), visual analogue scale (VAS), and lumbar flexion range of motion (ROM) have been assessed pre and post-6 weeks of the intervention.
RESULTS


Significant improvements were observed in the Nd:YAG group (MODI, P < .001; PDI, P = .007; VAS, P < .001; lumbar ROM, P = .002), whereas the sham group showed no significant changes (MODI, P = .451; PDI, P = .339; VAS, P = .107; lumbar ROM, P = .296) after 6-week intervention. Between-group comparisons showed significant differences in tending toward the Nd:YAG group (MODI, P < .001; PDI, P = .046; VAS, P < .001; lumbar ROM, P = .003).
CONCLUSIONS


Regarding the present study outcomes, short-term pulsed Nd:YAG laser (6 weeks) may reduce functional disabilities and pain intensity, and improve the lumbar flexion ROM in patients with chronic nonspecific LBP. Further well-designed randomized controlled studies with large sample sizes should be conducted regarding laser treatment.",2020,"RESULTS


Significant improvements were observed in the Nd:YAG group (MODI, P < .001; PDI, P = .007; VAS, P < .001; lumbar ROM, P = .002), whereas the sham group showed no significant changes (MODI, P = .451; PDI, P = .339; VAS, P = .107; lumbar ROM, P = .296) after 6-week intervention.","['chronic nonspecific low back pain', 'Thirty-five individuals with chronic nonspecific LBP were included in the study from December 2019 to March 2020', 'patients with chronic nonspecific LBP', 'Chronic non-specific low back pain (LBP', 'chronic non-specific LBP individuals']","['pulsed Nd: YAG laser therapy', 'short-term pulsed Nd:YAG laser', 'Nd:YAG laser']","['lumbar flexion ROM', 'Modified Oswestry disability index (MODI), pain disability index (PDI), visual analogue scale (VAS), and lumbar flexion range of motion (ROM', 'functional disabilities and pain intensity']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",35.0,0.0402863,"RESULTS


Significant improvements were observed in the Nd:YAG group (MODI, P < .001; PDI, P = .007; VAS, P < .001; lumbar ROM, P = .002), whereas the sham group showed no significant changes (MODI, P = .451; PDI, P = .339; VAS, P = .107; lumbar ROM, P = .296) after 6-week intervention.","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Shereen H', 'Initials': 'SH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health and Rehabilitation Sciences, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Alrawaili', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nahla N', 'Initials': 'NN', 'LastName': 'Ataalla', 'Affiliation': 'Department of Radiological Sciences and Medical Imaging, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abodonya', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ayman K', 'Initials': 'AK', 'LastName': 'Saleh', 'Affiliation': 'Department of Orthopedic, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Riyadh, Saudi Arabia.'}]",Medicine,['10.1097/MD.0000000000022098']
1894,32899094,Comparison of ropivacaine plus sufentanil and ropivacaine plus dexmedetomidine for labor epidural analgesia: A randomized controlled trial protocol.,"OBJECTIVE


Effective analgesia during delivery can not only decrease pain, but also have a significant function in ensuring the safety of baby and mother. Sufentanil is generally used opioid with ropivacaine in epidural anesthesia in labor pain management; however it can cause some adverse reaction. Dexmedetomidine is an a2-adrenoceptor agonist with high selectivity. It possesses opioid-sparing and analgesic effects and it is suitable for the long-term and short-term intraoperative sedation. The purpose of this present study is to compare the analgesic effect of ropivacaine with dexmedetomidine against ropivacaine with sufentanyl in epidural labor.
METHODS


This is a single center, placebo-controlled randomized trial which will be performed from May 2020 to May 2021. It was authorized via the Institutional Review Committee in the first medical center of Chinese PLA General Hospital (S2018-211-0). One hundred sixty full-term protozoa are included in this work. They are randomly divided into four groups (n = 40 per group): the RD1 group (with the epidural administration of 0.125% ropivacaine + dexmedetomidine of 0.5 μg/mL), and the RD2 group (with the epidural administration of 0.08% ropivacaine + dexmedetomidine 0.5 μg/mL), the RS1 group (with the epidural administration of 0.125% ropivacaine + sufentanil of 0.5 μg/mL), as well as RS2 group (with the epidural administration of 0.08% ropivacaine + sufentanil of 0.5 μg/mL). Clinical outcomes are pain score, a modified Bromage scale, the Ramsay Sedation Scale, and adverse reactions during analgesia. All the needed analyses are implemented through utilizing SPSS for Windows Version 20.0.
RESULTS


The first table shows the clinical outcomes between these four groups.
CONCLUSION


This current work can provide a primary evidence regarding the clinical outcomes of dexmedetomidine versus sufentanil for labor epidural analgesia.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5877).",2020,"Clinical outcomes are pain score, a modified Bromage scale, the Ramsay Sedation Scale, and adverse reactions during analgesia.","['labor pain management', 'One hundred sixty full-term protozoa are included in this work', 'labor epidural analgesia']","['RD2 group (with the epidural administration of 0.08% ropivacaine + dexmedetomidine', 'sufentanil', 'ropivacaine', 'RS1 group (with the epidural administration of 0.125% ropivacaine + sufentanil', 'ropivacaine plus sufentanil', 'ropivacaine plus dexmedetomidine', 'Dexmedetomidine', 'RD1 group (with the epidural administration of 0.125% ropivacaine + dexmedetomidine', 'placebo', 'ropivacaine + sufentanil', 'dexmedetomidine', 'Sufentanil']","['pain score, a modified Bromage scale, the Ramsay Sedation Scale, and adverse reactions', 'analgesic effect']","[{'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033739', 'cui_str': 'Kingdom Protozoa'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4517417', 'cui_str': '0.08'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4517427', 'cui_str': '0.125'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1301887', 'cui_str': 'Bromage scale'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",,0.124476,"Clinical outcomes are pain score, a modified Bromage scale, the Ramsay Sedation Scale, and adverse reactions during analgesia.","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesia, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Maowei', 'Initials': 'M', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022113']
1895,32875733,Ketonemia and Glycemia Affect Appetite Levels and Executive Functions in Overweight Females During Two Ketogenic Diets.,"OBJECTIVE


This study sought to investigate how glycemia and ketonemia variations during two ketogenic diet protocols affect appetite, executive functions, and mood in young women with overweight.
METHODS


Fifty healthy young females with overweight were randomly assigned to (1) a ketogenic diet without any restriction on energy intake, (2) a commercial energy-restricted ketogenic Mediterranean diet, and (3) an energy-restricted Mediterranean diet for 10 days. A visual analogue scale was used to test appetite, and one mood test and two cognitive tasks (working memory and inhibition control) were performed. Moreover, body composition, fasting blood glucose, and β-hydroxybutyrate (BHB) were measured.
RESULTS


A positive correlation was found between glycemia and appetite (P = 0.019), unfullness score (P =  0.001), and desire to eat (P = 0.030) (pre- and postdiet levels). Postdiet BHB levels showed a positive correlation with fullness score (P = 0.002) and a negative correlation with appetite (P = 0.022) and desire to eat (P = 0.009). A positive correlation was found between prediet levels of glycemia and reaction times in the go-trials of the executive function test (P = 0.018). Postdiet BHB level showed a negative correlation with the accuracy of the no-go trials (P = 0.027).
CONCLUSIONS


Ketogenic diets, compared with a Mediterranean diet, have a greater effect in terms of appetite reduction but might affect inhibition functions.",2020,A positive correlation was found between prediet levels of glycemia and reaction times in the go-trials of the executive function test (P = 0.018).,"['Fifty healthy young females with overweight', 'Overweight Females', 'young women with overweight']","['ketogenic diet without any restriction on energy intake, (2) a commercial energy-restricted ketogenic Mediterranean diet, and (3) an energy-restricted Mediterranean diet']","['appetite, executive functions, and mood', 'Ketonemia and Glycemia Affect Appetite Levels and Executive Functions', 'prediet levels of glycemia and reaction times', 'Postdiet BHB level', 'Postdiet BHB levels', 'body composition, fasting blood glucose, and β-hydroxybutyrate (BHB', 'desire to eat', 'fullness score', 'glycemia and appetite', 'unfullness score']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0235430', 'cui_str': 'Ketonemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.0252327,A positive correlation was found between prediet levels of glycemia and reaction times in the go-trials of the executive function test (P = 0.018).,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Lodi', 'Affiliation': 'Department of Biomedical Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zarantonello', 'Affiliation': 'Department of Medicine, University of Padua, Padua, Italy.'}, {'ForeName': 'Patrizia Silvia', 'Initials': 'PS', 'LastName': 'Bisiacchi', 'Affiliation': 'Department of General Psychology, University of Padua, Padua, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cenci', 'Affiliation': 'Human Inspired Technology Research Center, University of Padua, Padua, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Paoli', 'Affiliation': 'Department of Biomedical Sciences, University of Padua, Padua, Italy.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22934']
1896,32875946,Comparing efficacy and safety of potassium hydroxide 5% solution with 5-fluorouracil cream in patients with actinic keratoses: a randomized controlled trial.,"BACKGROUND


Actinic keratosis (AK) is a pre-cancerous skin lesion, associated with development of squamous cell carcinoma. Current treatment options are limited.
OBJECTIVES


To compare the efficacy and safety of topical 5-fluorouracil cream (5-FU) and potassium hydroxide 5% (KOH) in the treatment of AK.
METHODS


Eighteen patients with AK applied KOH solution or 5-FU on each side of their scalp/face, randomly. The efficacy and safety of these treatments were compared.
RESULTS


Thirteen (118 lesions) and ten (83 lesions) patients were successfully followed for one and three months, respectively. After one month, KOH showed a better clinical response (81% vs. 58%;  p -value = 0.007) and dermoscopic response (KOH, 65% vs. 5-FU, 46%;  p -value = 0.04); while no differences were noted after three months (clinical response, 83% vs.70%,  p -value = 0.1; dermoscopic response, 76% vs. 59%,  p -value = 0.1). No significant differences in the recurrence rate of the lesion between the two groups were noted at the end of the third month ( p -value = 0.5). Regarding the safety of the treatments, the risk of developing erythema, scaling, sand swelling was higher in 5-FU group ( p -value < 0.0001, for all), while more patients in KOH group had erosion and ulcer ( p -value < 0.001 for both). KOH was up to 96% less expensive than 5-FU.
LIMITATIONS


Low number of patients and short-term follow-up limited the analysis.
CONCLUSION


KOH solution offers a faster and less expensive resolution of AK lesions than does 5-FU.
CLINICAL TRIAL CODE (IRCT.IR)


IRCT20180909040978N1.",2020,No significant differences in the recurrence rate of the lesion between the two groups were noted at the end of the third month (P-value =0.5).,"['Eighteen patients with AK applied', 'patients with actinic keratoses', 'Thirteen (118 lesions) and ten (83 lesions) patients']","[' : Actinic keratosis (AK', 'KOH', '5-FU', 'KOH solution or 5-FU', 'potassium hydroxide 5% solution with 5-fluorouracil cream', 'topical 5-fluorouracil cream (5-FU) and potassium hydroxide 5% (KOH']","['recurrence rate of the lesion', 'efficacy and safety', 'clinical response', 'KOH', 'dermoscopic response', 'expensive resolution of AK lesions', 'risk of developing erythema, scaling, sand swelling', 'erosion and ulcer']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C3215191', 'cui_str': 'Fluorouracil-containing product in cutaneous dose form'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C4759711', 'cui_str': 'Sand'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",18.0,0.0573959,No significant differences in the recurrence rate of the lesion between the two groups were noted at the end of the third month (P-value =0.5).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Salehi Farid', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Niknam', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Kheirollah', 'Initials': 'K', 'LastName': 'Gholami', 'Affiliation': 'Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Tavakolpour', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Teimourpour', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Daneshpazhooh', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Nili', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arghavan', 'Initials': 'A', 'LastName': 'Azizpour', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nasimi', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Mahmoudi', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1817839']
1897,32871701,Development and efficacy of a family-focused treatment for depression in childhood.,"BACKGROUND


Depression in childhood frequently involves significant impairment, comorbidity, stress, and mental health problems within the family. Family-Focused Treatment for Childhood Depression (FFT-CD) is a 15-session developmentally-informed, evidence-based intervention targeting family interactions to enhance resiliency within the family system to improve and manage childhood depression.
METHODS


We present the conceptual framework underlying FFT-CD, the treatment development process, the intervention strategies, a case illustration, and efficacy data from a recent 2-site randomized clinical trial (N = 134) of 7-14 year old children randomly assigned to FFT-CD or individual supportive psychotherapy (IP) conditions.
RESULTS


Compared to children randomized to IP, those randomized to FFT-CD showed higher rates of depression response (≥50% Children's Depression Rating Scale-Revised reduction) across the course of acute treatment (77.7% vs. 59.9%, t = 1.97, p = .0498). The rate of improvement overall leveled off following treatment with a high rate of recovery from index depressive episodes in both groups (estimated 76% FFT-CD, 77% IP), and there was an attenuation of observed group differences. By final follow-up (9 months post-treatment), one FFT-CD child and six IP children had suffered depressive recurrences, and four IP children attempted suicide.
LIMITATIONS


Without a no treatment control group it is not possible to disentangle the impact of the interventions from time alone.
CONCLUSIONS


While seldom evaluated, family interventions may be particularly appropriate for childhood depression. FFT-CD has demonstrated efficacy compared to individual supportive therapy. However, findings underscore the need for an extended/chronic disease model to enhance outcomes and reduce risk over time.",2020,"The rate of improvement overall leveled off following treatment with a high rate of recovery from index depressive episodes in both groups (estimated 76% FFT-CD, 77% IP), and there was an attenuation of observed group differences.","['depression in childhood', 'N\xa0=\xa0134) of 7-14 year old children randomly assigned to']","['FFT-CD or individual supportive psychotherapy (IP) conditions', 'FFT-CD']","['suffered depressive recurrences', 'index depressive episodes', 'rates of depression response']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0417671,"The rate of improvement overall leveled off following treatment with a high rate of recovery from index depressive episodes in both groups (estimated 76% FFT-CD, 77% IP), and there was an attenuation of observed group differences.","[{'ForeName': 'Martha C', 'Initials': 'MC', 'LastName': 'Tompson', 'Affiliation': 'Department of Psychological & Brain Sciences, Boston University, 900 Commonwealth Ave, 2nd Floor, Boston, MA 02215, United States. Electronic address: mtompson@bu.edu.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Langer', 'Affiliation': 'Department of Psychology, Suffolk University, Boston, MA, United States.'}, {'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Asarnow', 'Affiliation': 'UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, CA, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2020.06.057']
1898,32880181,"Nutrivolatilomics of Urinary and Plasma Samples to Identify Candidate Biomarkers after Cheese, Milk, and Soy-Based Drink Intake in Healthy Humans.","The characterization of volatile compounds in biological fluids offers a distinct approach to study the metabolic imprint of foods on the human metabolome, particularly to identify novel biomarkers of food intake (BFIs) that are not captured by classic metabolomics. Using a combination of dynamic headspace vacuum transfer In Trap extraction and gas chromatography coupled with mass spectrometry, we measured volatile compounds (the ""volatilome"") in plasma and urine samples from a randomized controlled crossover intervention study in which 11 healthy subjects ingested milk, cheese, or a soy-based drink. More than 2000 volatile compounds were detected in plasma, while 1260 compounds were detected in urine samples. A postprandial response in plasma was confirmed for 697 features. Univariate and multivariate analyses identified four molecules in plasma and 31 molecules in urine samples differentiating the ingestion of the foods, of which three metabolites in plasma and nine in urine were specific to the dairy products. Among these molecules, heptan-2-one, 3,5-dimethyloctan-2-one, and undecan-2-one in plasma and 3-ethylphenol, heptan-2-one, 1-methoxy-2-propyl acetate, and 9-decenoic acid were highly discriminative for dairy or cheese intake. In urine, 22 volatile compounds were highly discriminative for soy-based drink intake. The majority of these molecules have not been reported in humans. Our findings highlight the potential of plasma and urinary volatilomics for detection of novel dietary biomarkers.",2020,"Univariate and multivariate analyses identified four molecules in plasma, and 31 molecules in urine samples differentiating the ingestion of the foods, of which three metabolites in plasma, and nine in urine, were specific to the dairy products.","['11 healthy subjects ingested milk, cheese or a soy-based drink', 'Healthy Humans']",[],[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]",[],[],11.0,0.0284495,"Univariate and multivariate analyses identified four molecules in plasma, and 31 molecules in urine samples differentiating the ingestion of the foods, of which three metabolites in plasma, and nine in urine, were specific to the dairy products.","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Fuchsmann', 'Affiliation': 'Agroscope, Schwarzenburgstrasse 161, 3003 Bern, Switzerland.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Tena Stern', 'Affiliation': 'Agroscope, Schwarzenburgstrasse 161, 3003 Bern, Switzerland.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Münger', 'Affiliation': 'Agroscope, Schwarzenburgstrasse 161, 3003 Bern, Switzerland.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Pimentel', 'Affiliation': 'Agroscope, Schwarzenburgstrasse 161, 3003 Bern, Switzerland.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Burton', 'Affiliation': 'Agroscope, Schwarzenburgstrasse 161, 3003 Bern, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Vionnet', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, 1011 Lausanne, Switzerland.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Vergères', 'Affiliation': 'Agroscope, Schwarzenburgstrasse 161, 3003 Bern, Switzerland.'}]",Journal of proteome research,['10.1021/acs.jproteome.0c00324']
1899,32880954,Relative accuracy of social and medical determinants of suicide in electronic health records.,"OBJECTIVE


This paper compares the accuracy of predicting suicide from Social Determinants of Health (SDoH) or history of illness.
POPULATION STUDIED


5 313 965 Veterans who at least had two primary care visits between 2008 and 2016.
STUDY DESIGN


The dependent variable was suicide or intentional self-injury. The independent variables were 10 495 International Classification of Disease (ICD) Version 9 codes, age, and gender. The ICD codes included 40 V-codes used for measuring SDoH, such as family disruption, family history of substance abuse, lack of education, legal impediments, social isolation, unemployment, and homelessness. The sample was randomly divided into training (90 percent) and validation (10 percent) sets. Area under the receiver operating characteristic (AROC) was used to measure accuracy of predictions in the validation set.
PRINCIPAL FINDINGS


Separate analyses were done for inpatient and outpatient codes; the results were similar. In the hospitalized group, the mean age was 67.2 years, and 92.1 percent were male. The mean number of medical diagnostic codes during the study period was 37; and 12.9 percent had at least one SDoH V-code. At least one episode of suicide or intentional self-injury occurred in 1.89 percent of cases. SDoH V-codes, on average, elevated the risk of suicide or intentional self-injury by 24-fold (ranging from 4- to 86-fold). An index of 40 SDoH codes predicted suicide or intentional self-injury with an AROC of 0.64. An index of 10 445 medical diagnoses, without SDoH V-codes, had AROC of 0.77. The combined SDoH and medical diagnoses codes also had AROC of 0.77.
CONCLUSION


In predicting suicide or intentional self-harm, SDoH V-codes add negligible information beyond what is already available in medical diagnosis codes.
IMPLICATIONS FOR PRACTICE


Policies that affect SDoH (eg, housing policies, resilience training) may not have an impact on suicide rates, if they do not change the underlying medical causes of SDoH.",2020,"SDoH V-codes, on average, elevated the risk of suicide or intentional self-injury by 24-fold (ranging from 4- to 86-fold).","['hospitalized group, the mean age was 67.2\xa0years, and 92.1 percent were male', '313\xa0965 Veterans who at least had two primary care visits between 2008 and 2016', '5']",[],"['mean number of medical diagnostic codes', 'episode of suicide or intentional self-injury']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0853089', 'cui_str': 'Intentional self-injury'}]",,0.0424179,"SDoH V-codes, on average, elevated the risk of suicide or intentional self-injury by 24-fold (ranging from 4- to 86-fold).","[{'ForeName': 'Farrokh', 'Initials': 'F', 'LastName': 'Alemi', 'Affiliation': 'Department of Health Administration and Policy, George Mason University, Virginia.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Avramovic', 'Affiliation': 'Department of Health Administration and Policy, George Mason University, Virginia.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Renshaw', 'Affiliation': 'Department of Psychology, George Mason University, Virginia.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Kanchi', 'Affiliation': 'Department of Population Health, New York University, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schwartz', 'Affiliation': 'Department of Population Health, New York University, New York.'}]",Health services research,['10.1111/1475-6773.13540']
1900,32877651,"Efficacy and safety of trimetazidine after percutaneous coronary intervention (ATPCI): a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Angina might persist or reoccur despite successful revascularisation with percutaneous coronary intervention (PCI) and antianginal therapy. Additionally, PCI in stable patients has not been shown to improve survival compared with optimal medical therapy. Trimetazidine is an antianginal agent that improves energy metabolism of the ischaemic myocardium and might improve outcomes and symptoms of patients who recently had a PCI. In this study, we aimed to assess the long-term potential benefits and safety of trimetazidine added to standard evidence-based medical treatment in patients who had a recent successful PCI.
METHODS


We did a randomised, double-blind, placebo-controlled, event-driven trial of trimetazidine added to standard background therapy in patients who had undergone successful PCI at 365 centres in 27 countries across Europe, South America, Asia, and north Africa. Eligible patients were aged 21-85 years and had had either elective PCI for stable angina or urgent PCI for unstable angina or non-ST segment elevation myocardial infarction less than 30 days before randomisation. Patients were randomly assigned by an interactive web response system to oral trimetazidine 35 mg modified-release twice daily or matching placebo. Participants, study investigators, and all study staff were masked to treatment allocation. The primary efficacy endpoint was a composite of cardiac death; hospital admission for a cardiac event; recurrence or persistence of angina requiring an addition, switch, or increase of the dose of at least one antianginal drug; or recurrence or persistence of angina requiring a coronary angiography. Efficacy analyses were done according to the intention-to-treat principle. Safety was assessed in all patients who had at least one dose of study drug. This study is registered with the EU Clinical Trials Register (EudraCT 2010-022134-89).
FINDINGS


From Sept 17, 2014, to June 15, 2016, 6007 patients were enrolled and randomly assigned to receive either trimetazidine (n=2998) or placebo (n=3009). After a median follow-up of 47·5 months (IQR 42·3-53·3), incidence of primary endpoint events was not significantly different between the trimetazidine group (700 [23·3%] patients) and the placebo group (714 [23·7%]; hazard ratio 0·98 [95% CI 0·88-1·09], p=0·73). When analysed individually, there were no significant differences in the incidence of the components of the primary endpoint between the treatment groups. Similar results were obtained when patients were categorised according to whether they had an elective or urgent PCI. 1219 (40·9%) of 2983 patients in the trimetazidine group and 1230 (41·1%) of 2990 patients in the placebo group had serious treatment-emergent adverse events. Frequencies of adverse events of interest were similar between the groups.
INTERPRETATION


Our results show that the routine use of oral trimetazidine 35 mg twice daily over several years in patients receiving optimal medical therapy, after successful PCI, does not influence the recurrence of angina or the outcome; these findings should be taken into account when considering the place of trimetazidine in clinical practice. However, the long-term prescription of this treatment does not appear to be associated with any statistically significant safety concerns in the population studied.
FUNDING


Servier.",2020,"When analysed individually, there were no significant differences in the incidence of the components of the primary endpoint between the treatment groups.","['patients who recently had a PCI', 'Eligible patients were aged 21-85 years and had had either elective PCI for stable angina or urgent PCI for unstable angina or non-ST segment elevation myocardial infarction less than 30 days before randomisation', 'From Sept 17, 2014, to June 15, 2016', 'patients who had a recent successful PCI', 'patients who had undergone successful PCI at 365 centres in 27 countries across Europe, South America, Asia, and north Africa', 'patients who had at least one dose of study drug', '6007 patients']","['Trimetazidine', 'trimetazidine 35 mg modified-release twice daily or matching placebo', 'percutaneous coronary intervention (ATPCI', 'percutaneous coronary intervention (PCI) and antianginal therapy', 'placebo', 'trimetazidine']","['Safety', 'serious treatment-emergent adverse events', 'incidence of primary endpoint events', 'Efficacy and safety', 'survival', 'composite of cardiac death; hospital admission for a cardiac event; recurrence or persistence of angina requiring an addition, switch, or increase of the dose of at least one antianginal drug; or recurrence or persistence of angina requiring a coronary angiography']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0001745', 'cui_str': 'Northern Africa'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C1383981', 'cui_str': 'Trimetazidine 35 MG'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0585942', 'cui_str': 'Antianginal therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]",6007.0,0.677741,"When analysed individually, there were no significant differences in the incidence of the components of the primary endpoint between the treatment groups.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ferrari', 'Affiliation': 'Cardiovascular Centre, University of Ferrara, Ospedale di Cona, Ferrara, Italy; Maria Cecilia Hospital, Cotignola, Ravenna, Italy. Electronic address: fri@unife.it.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Fox', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK; Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Jean Pascal', 'Initials': 'JP', 'LastName': 'Challeton', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Correges', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Tendera', 'Affiliation': 'Department of Cardiology and Structural Heart Disease, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Widimský', 'Affiliation': 'Cardiocenter, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Danchin', 'Affiliation': 'Department of Cardiology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France; Université Paris-Descartes, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31790-6']
1901,32877652,SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: a meta-analysis of the EMPEROR-Reduced and DAPA-HF trials.,"BACKGROUND


Both DAPA-HF (assessing dapagliflozin) and EMPEROR-Reduced (assessing empagliflozin) trials showed that sodium-glucose co-transporter-2 (SGLT2) inhibition reduced the combined risk of cardiovascular death or hospitalisation for heart failure in patients with heart failure with reduced ejection fraction (HFrEF) with or without diabetes. However, neither trial was powered to assess effects on cardiovascular death or all-cause death or to characterise effects in clinically important subgroups. Using study-level published data from DAPA-HF and patient-level data from EMPEROR-Reduced, we aimed to estimate the effect of SGLT2 inhibition on fatal and non-fatal heart failure events and renal outcomes in all randomly assigned patients with HFrEF and in relevant subgroups from DAPA-HF and EMPEROR-Reduced trials.
METHODS


We did a prespecified meta-analysis of the two single large-scale trials assessing the effects of SGLT2 inhibitors on cardiovascular outcomes in patients with HFrEF with or without diabetes: DAPA-HF (assessing dapagliflozin) and EMPEROR-Reduced (assessing empagliflozin). The primary endpoint was time to all-cause death. Additionally, we assessed the effects of treatment in prespecified subgroups on the combined risk of cardiovascular death or hospitalisation for heart failure. These subgroups were based on type 2 diabetes status, age, sex, angiotensin receptor neprilysin inhibitor (ARNI) treatment, New York Heart Association (NYHA) functional class, race, history of hospitalisation for heart failure, estimated glomerular filtration rate (eGFR), body-mass index, and region (post-hoc). We used hazard ratios (HRs) derived from Cox proportional hazard models for time-to-first event endpoints and Cochran's Q test for treatment interactions; the analysis of recurrent events was based on rate ratios derived from the Lin-Wei-Yang-Ying model.
FINDINGS


Among 8474 patients combined from both trials, the estimated treatment effect was a 13% reduction in all-cause death (pooled HR 0·87, 95% CI 0·77-0·98; p=0·018) and 14% reduction in cardiovascular death (0·86, 0·76-0·98; p=0·027). SGLT2 inhibition was accompanied by a 26% relative reduction in the combined risk of cardiovascular death or first hospitalisation for heart failure (0·74, 0·68-0·82; p<0·0001), and by a 25% decrease in the composite of recurrent hospitalisations for heart failure or cardiovascular death (0·75, 0·68-0·84; p<0·0001). The risk of the composite renal endpoint was also reduced (0·62, 0·43-0·90; p=0·013). All tests for heterogeneity of effect size between trials were not significant. The pooled treatment effects showed consistent benefits for subgroups based on age, sex, diabetes, treatment with an ARNI and baseline eGFR, but suggested treatment-by-subgroup interactions for subgroups based on NYHA functional class and race.
INTERPRETATION


The effects of empagliflozin and dapagliflozin on hospitalisations for heart failure were consistent in the two independent trials and suggest that these agents also improve renal outcomes and reduce all-cause and cardiovascular death in patients with HFrEF.
FUNDING


Boehringer Ingelheim.",2020,"inhibition was accompanied by a 26% relative reduction in the combined risk of cardiovascular death or first hospitalisation for heart failure (0·74, 0·68-0·82; p<0·0001), and by a 25% decrease in the composite of recurrent hospitalisations for heart failure or cardiovascular death (0·75, 0·68-0·84; p<0·0001).","['8474 patients', 'randomly assigned patients with HFrEF and in relevant subgroups from DAPA-HF and EMPEROR-Reduced trials', 'These subgroups were based on type 2 diabetes status, age, sex, angiotensin receptor neprilysin inhibitor (ARNI) treatment, New York Heart Association (NYHA) functional class, race, history of hospitalisation for heart failure, estimated glomerular filtration rate (eGFR), body-mass index, and region (post-hoc', 'patients with HFrEF with or without diabetes', 'patients with heart failure with reduced ejection fraction', 'patients with heart failure with reduced ejection fraction (HFrEF) with or without diabetes']","['sodium-glucose co-transporter-2 (SGLT2) inhibition', 'SGLT2', 'empagliflozin and dapagliflozin', 'SGLT2 inhibitors', 'DAPA-HF (assessing dapagliflozin) and EMPEROR-Reduced (assessing empagliflozin', 'DAPA-HF (assessing dapagliflozin']","['risk of the composite renal endpoint', 'cardiovascular death or hospitalisation for heart failure', 'cardiovascular outcomes', 'hospitalisations for heart failure', 'renal outcomes and reduce all-cause and cardiovascular death', 'cause death', 'hazard ratios (HRs', 'time to all-cause death', 'cardiovascular death or first hospitalisation for heart failure', 'cardiovascular death', 'composite of recurrent hospitalisations for heart failure or cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",,0.124599,"inhibition was accompanied by a 26% relative reduction in the combined risk of cardiovascular death or first hospitalisation for heart failure (0·74, 0·68-0·82; p<0·0001), and by a 25% decrease in the composite of recurrent hospitalisations for heart failure or cardiovascular death (0·75, 0·68-0·84; p<0·0001).","[{'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Centre d'Investigations Cliniques Plurithématique 1433, Université de Lorraine, Institut National de la Santé et de la Recherche Médicale 1116, Centre Hospitalier Régional Universitaire de Nancy, French Clinical Research Infrastructure Network, Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France. Electronic address: f.zannad@chru-nancy.fr.""}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Centre d'Investigations Cliniques Plurithématique 1433, Université de Lorraine, Institut National de la Santé et de la Recherche Médicale 1116, Centre Hospitalier Régional Universitaire de Nancy, French Clinical Research Infrastructure Network, Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.""}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi School of Medicine, Jackson, MS, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens, Greece.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany; Faculty of Medicine, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Medical Department, Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Egon', 'Initials': 'E', 'LastName': 'Pfarr', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA; Imperial College London, London, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31824-9']
1902,32877722,Characteristics of contents in the upper gastrointestinal lumen after a standard high-calorie high-fat meal and implications for the in vitro drug product performance testing conditions.,"OBJECTIVES


To measure the pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen after a standard high-calorie, high-fat meal as well as the osmolality, lipid content and bile acid content in the aqueous phase of the gastric contents and the micellar phase of contents of the upper small intestine. To evaluate the implications of these findings for the composition of biorelevant media employed in vitro oral drug product performance testing representing the upper GI conditions after ingestion of the standard meal.
METHODS


Eight healthy male adult volunteers participated in a two-phase, crossover study in which a homogenized standard meal was administered to the antrum via the gastric port of a naso-gastro-intestinal tube. A glass of tap water and single paracetamol and danazol doses were administered to the antrum of the stomach 30 min after the initiation of meal administration (Pentafragka et al., 2020). Samples were aspirated from the antrum and the upper small intestine over the next four hours. The pH and the buffer capacity of the samples were measured immediately upon aspiration, while viscosity, osmolality, and presence of solubilizing agents were measured after storage at -70 °C.
RESULTS


The composition of gastric contents over time fluctuated less after the homogenized standard meal than after liquid meals with similar composition. Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low. Mean viscosity values in the stomach at 100 s -1  were 80-800 times higher than in the fasted state for more than 3 h after the standard meal. In the upper small intestine, mean viscosity values at 100 s -1  were at least 100 times higher than in the fasted state for 4 h after the standard meal.
CONCLUSIONS


Based on data collected in this study, Level I and Level II biorelevant media simulating the intragastric conditions after ingestion of a standard meal could be simplified whereas FeSSIF-V2 composition was confirmed to be representative of the composition of contents in the upper small intestine. Representative values of viscosity in the stomach and the upper small intestine and Level II composition of the aqueous phase of gastric contents, after the standard meal, are proposed for first time.",2020,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,['Eight healthy male adult volunteers'],"['homogenized standard meal', 'paracetamol and danazol']","['Mean viscosity values', 'mean viscosity values', 'viscosity, osmolality, and presence of solubilizing agents', 'pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0444664', 'cui_str': 'Standard meal'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}]",8.0,0.0385476,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dressman', 'Affiliation': 'Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105535']
1903,32877791,"Parents as Teachers: Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran.","BACKGROUND


Parents play an important role in protecting their children from sexual abuse. Mothers, in particular, play key roles in the sexual socialization of their children and in educating their children about child sexual abuse (CSA).
OBJECTIVES


The purpose of this study was to determine whether preschool girls in Gorgan (a city in northern Iran) could learn personal safety skills when taught by their mothers.
PARTICIPANTS AND SETTING


Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers. Mean age of girls was 6.34 years.
METHODS


Girls were pretested using Persian versions of the Personal Safety Questionnaire and 'What If' Situations Test, randomly assigned to either a mother-taught program or wait-list control, and post-tested. Mothers assigned to the education group participated in a two-hour workshop on preventing CSA and were given the Body Safety Training workbook to teach their daughters. Following the one-week training by their mothers, children in both groups were post-tested and follow-up tested one month later.
RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
CONCLUSION


Results suggest that mothers can effectively teach their young daughters personal safety skills. Difficulties female children have in recognizing appropriate-touch requests are discussed and compared to results in other developing countries. Advantages of home-based instruction for young children are described and suggestions for increasing parent participation are offered.",2020,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[""Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran"", 'Mean age of girls was 6.34 years', 'Difficulties female children', 'Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers', 'young children', 'Parents as Teachers', 'Girls', 'preschool girls in Gorgan (a city in northern Iran']","['home-based instruction', 'mother-taught program or wait-list control, and post-tested']",['knowledge about sexual abuse and higher levels of personal safety skills'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.0148705,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Khoori', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: elhamkhoori@yahoo.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Gholamfarkhani', 'Affiliation': 'Department of Obstetrics and Gynecology, Shohada Hospital of Quchan, Mashhad University of Medical Sciences, Quchan, Iran. Electronic address: somayeh.farkhani@gmail.com.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Tatari', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: maisa.tatari@yahoo.com.'}, {'ForeName': 'Sandy K', 'Initials': 'SK', 'LastName': 'Wurtele', 'Affiliation': 'Department of Psychology, University of Colorado, Colorado Springs, USA. Electronic address: swurtele@uccs.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104695']
1904,32879130,Correlation between cardiac resynchronization response and pulmonary artery hemodynamic parameters.,"OBJECTIVES


To evaluate the response to cardiac resynchronization therapy (CRT) and the correlation between CRT and pulmonary artery hemodynamic parameters.
METHODS


The patients with chronic heart failure indicator for CRT were enrolled. The left ventricular end-systolic volume (LVESV) was measured by echocardiography and New York Heart Association (NYHA) classification was evaluated between one week before and six months after CRT. Mean pulmonary artery pressure (mPAP), pulmonary artery systolic pressure (PASP) and pulmonary vascular resistance (PVR) were measured by right heart catheterization. Left ventricular reverse remodeling (LVRR) is defined as a decrease of 15% or more in LVESV at the 6th month after CRT; Clinical response is defined as a decrease of NYHA classification at or above grade 1 at the 6th month after CRT. Pulmonary hypertension (PH) was defined as mPAP≥25 mmHg. According to the response, patients were divided into 3 groups: group A (LVRR+clinical response), group B (no LVRR+clinical response) and group C (no LVRR+no clinical response). The changes of NYHA classification, echocardiographic and pulmonary hemodynamic parameters were observed in the 3 groups. The Kaplan-Meier survival curve was used to analyze the differences in all-cause mortality, combined end-point events of death or re-hospitalization due to heart failure among different groups.
RESULTS


A total of 45 patients with CRT implantation [aged (63.27±9.55) years, 36 males] were included. The average follow-up period was (33.76±11.50) months. Thirty-one patients (68.89%) were in group A, 9 of whom with PH. Eight patients (17.78%) were in group B, 7 of whom with PH. Six patients were in group C, all with PH. Cardiac function including NYHA classification, echocardiographic and pulmonary hemodynamic parameters had been significantly improved in group A after CRT implantation ( P <0.05). In group B, NYHA classification and pulmonary hemodynamic parameters were decreased significantly ( P <0.05), but echocardiographic parameters did not change obviously ( P >0.05). There were no significant changes in NYHA classification, echocardiographic and pulmonary hemodynamic parameters in group C ( P >0.05). Compared with group C, group A and group B had lower all-cause mortality ( P =0.005) and lower incidence of composite endpoint events ( P =0.001).
CONCLUSIONS


Patients with LVRR and clinical response after CRT have a good prognosis. Patients with clinical response but without LVRR have a better prognosis than those without clinical response and LVRR, which may be related to the decrease of pulmonary hemodynamic parameters such as mPAP and TPG.",2020,"Cardiac function including NYHA classification, echocardiographic and pulmonary hemodynamic parameters had been significantly improved in group A after CRT implantation ( P <0.05).","['45 patients with CRT implantation [aged (63.27±9.55) years, 36 males', 'patients with chronic heart failure indicator for CRT were enrolled']","['cardiac resynchronization therapy (CRT', 'group A (LVRR+clinical response), group B (no LVRR+clinical response) and group C (no LVRR+no clinical response']","['echocardiographic parameters', 'NYHA classification, echocardiographic and pulmonary hemodynamic parameters', 'Left ventricular reverse remodeling (LVRR', 'cardiac resynchronization response and pulmonary artery hemodynamic parameters', 'cause mortality', 'NYHA classification and pulmonary hemodynamic parameters', 'changes of NYHA classification, echocardiographic and pulmonary hemodynamic parameters', 'Mean pulmonary artery pressure (mPAP), pulmonary artery systolic pressure (PASP) and pulmonary vascular resistance (PVR', 'Kaplan-Meier survival curve', 'Cardiac function including NYHA classification, echocardiographic and pulmonary hemodynamic parameters', 'Pulmonary hypertension (PH', 'left ventricular end-systolic volume (LVESV', 'echocardiography and New York Heart Association (NYHA) classification']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]",45.0,0.012316,"Cardiac function including NYHA classification, echocardiographic and pulmonary hemodynamic parameters had been significantly improved in group A after CRT implantation ( P <0.05).","[{'ForeName': 'Jiangjin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029. ljh197202@sina.com.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029.'}, {'ForeName': 'Henghao', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029.'}, {'ForeName': 'Zeyu', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029.'}, {'ForeName': 'Xinli', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029.'}, {'ForeName': 'Jiangang', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing 210029. jgzou@njmu.edu.cn.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.190520']
1905,32882517,"Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial.","BACKGROUND


Although the Gait Exercise Assist Robot (GEAR) has been reported to effectively improve gait of hemiplegic patients, no study has investigated its use in chronic stroke patients. It is possible to facilitate gait reorganization by gait training with less compensation using the GEAR even in chronic stroke patients.
RESEARCH QUESTION


What are the effects of GEAR training on the abnormal gait patterns of chronic stroke subjects?
METHODS


Subjects were randomly assigned to either the GEAR group (n = 8) or the treadmill group (n = 11). Each group underwent 20 sessions (40 min/day, 5 days/week). The changes in the 10 types of abnormal gait patterns were evaluated using a three-dimensional motion analysis system and the Global Rating of Change (GRC) scale before and after the intervention, and at 1-month and 3-month follow-up assessment.
RESULTS


In the GEAR group, hip hiking at a 1-month follow-up assessment was markedly lesser than that before the intervention, and the excessive hip external rotation at 3-month follow-up assessment was notably lesser than that after the intervention, but the change in excessive hip external rotation was in the normal range. In the treadmill group, knee extensor thrust at a 1-month follow-up assessment was strikingly lesser than that before the intervention, but the difference was in the normal range. In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention. But, in the treadmill group, only the GRC scale score at a 1-month follow-up assessment was visibly higher than that before the intervention.
SIGNIFICANCE


Gait training using the GEAR may be more effective than treadmill-training in improving the swing phase in chronic stroke subjects.",2020,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","['chronic stroke patients', 'chronic stroke subjects', 'Subjects']","['GEAR', 'Gait Exercise Assist Robot (GEAR', 'GEAR training', 'gait exercise assist robot (GEAR', 'Gait training']","['excessive hip external rotation', 'hip hiking', 'Global Rating of Change (GRC) scale', 'GRC scale score', 'GRC scale scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C4255280', 'cui_str': 'Hiking'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0196297,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan. Electronic address: ogino0327@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanata', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Uegaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Tatuya', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Katuhisa', 'Initials': 'K', 'LastName': 'Morisaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.017']
1906,32883567,Empagliflozin decreases the plasma concentration of plasminogen activator inhibitor-1 (PAI-1) in patients with type 2 diabetes: Association with improvement of fibrinolysis.,"AIMS


Elevation of the plasma concentration of plasminogen activator inhibitor-1 (PAI-1), a rapid-acting inhibitor of fibrinolysis, is associated with development of vascular thrombotic diseases, including coronary artery disease and stroke. We investigated the effects of empagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, on the plasma concentration of PAI-1 and fibrinolytic activity in patients with type 2 diabetes.
METHODS


In a randomized, active-controlled, open-label trial, 51 patients with type 2 diabetes were randomly allocated at a 2:1 ratio to receive empagliflozin (10 mg/day, n = 31) or standard therapy (n = 18) for 12 weeks. We measured the plasma concentrations of PAI-1 and plasmin-α2-antiplasmin complex (PAP) as indicators of fibrinolytic activity. Serum leptin and high-molecular weight (HMW) adiponectin were also measured.
RESULTS


In 49 patients who completed the trial, baseline plasma PAI-1 showed a positive correlation with body weight, visceral fat area (VFA), γ-glutamyltranspeptidase (GGT), leptin, and the platelet count, while it showed a negative correlation with HDL cholesterol and PAP. Body weight and VFA decreased significantly in the empagliflozin group, but not in the control group. The serum level of GGT showed a significant decrease at 12 weeks in the empagliflozin group, while it was unchanged in the control group. Serum HMW adiponectin increased significantly in the empagliflozin group. Plasma PAI-1 decreased significantly by 25% in the empagliflozin group, but not in the control group. In the empagliflozin group, the change of plasma PAI-1 was positively correlated with the changes of body weight and leptin, but was negatively correlated with the change of PAP.
CONCLUSIONS


Empagliflozin reduced the plasma PAI-1 concentration through its synergistic actions of a glucose-lowering effect, VFA loss, and restoring the adipokine balance. (Clinical trial registry: UMIN000025418).",2020,"Plasma PAI-1 decreased significantly by 25% in the empagliflozin group, but not in the control group.","['patients with type 2 diabetes', '49 patients', '51 patients with type 2 diabetes']","['Empagliflozin', 'empagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor', 'empagliflozin', 'standard therapy']","['change of plasma PAI-1', 'plasma PAI-1 concentration', 'body weight, visceral fat area (VFA), γ-glutamyltranspeptidase (GGT), leptin', 'Serum leptin and high-molecular weight (HMW) adiponectin', 'Body weight and VFA', 'body weight and leptin', 'plasma concentrations of PAI-1 and plasmin-α2-antiplasmin complex (PAP) as indicators of fibrinolytic activity', 'plasma concentration of PAI-1 and fibrinolytic activity', 'Serum HMW adiponectin', 'serum level of GGT', 'plasma concentration of plasminogen activator inhibitor-1 (PAI-1', 'Plasma PAI-1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0016016', 'cui_str': 'Plasmin'}, {'cui': 'C0003410', 'cui_str': 'Antiplasmin'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2733715', 'cui_str': 'High molecular weight adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}]",51.0,0.0384631,"Plasma PAI-1 decreased significantly by 25% in the empagliflozin group, but not in the control group.","[{'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Sakurai', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan.'}, {'ForeName': 'Teruo', 'Initials': 'T', 'LastName': 'Jojima', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan. Electronic address: jojima@dokkyomed.ac.jp.'}, {'ForeName': 'Toshie', 'Initials': 'T', 'LastName': 'Iijima', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Tomaru', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Usui', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan.'}, {'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Aso', 'Affiliation': 'Department of Endocrinology and Metabolism, Dokkyo Medical University, Tochigi 321-0293, Japan. Electronic address: yaso@dokkyomed.ac.jp.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107703']
1907,32885780,The Effects of Differing Invitation Models on the Uptake of Immunological Fecal Occult Blood Testing.,"BACKGROUND


Participation rates in colorectal cancer screening in Germany are low. We therefore investigated the effectiveness of different invitation models for immunological stool blood tests (fecal immunological tests, FITs).
METHODS


A randomized controlled trial in 50- to 54-year-old clients of the health insurance provider AOK Baden-Wuerttemberg. A total of 17 532 insured persons were randomized to receive: (A) an invitation letter including a FIT (n = 5850); (B) an invitation letter including an option to request a FIT (n = 5844); or (C) an invitation letter only (n = 5838; control group, routine practice). Reminder letters were sent to half the members of groups A and B, selected at random, after 4 weeks. The primary endpoint was the use of a FIT within 1 year of the date of the invitation letter. IRRID: RR2-10.2196/16413. Registration: DRKS00011858.
RESULTS


The invitation letter with a FIT enclosed (A) increased usage from 10% to 29.7% compared with the control group (+19.7% points, p < 0.0001; men: +19.4%, women: +18.8%). The invitation letter with a FIT request option (B) increased usage from 10% to 27.7% (+17.7% points, p < 0.0001; men: +17.7%, women: +17.4%). Reminders increased usage in group A by 7.5% points and in group B by 8.5% points. Participation among women was higher than among men in all groups. The FIT positivity rate was 6.9%. A subsequent colonoscopy was reported for 64.3% of FIT-positive participants, and advanced neoplasia was found in 21.3% of these cases.
CONCLUSION


Letters of invitation that include a FIT and those that offer low-threshold access to a FIT achieve strong, comparable increases in the usage of FIT in the context of colorectal cancer screening.",2020,Reminders increased usage in group A by 7.5% points and in group B by 8.5% points.,"['50- to 54-year-old clients of the health insurance provider AOK Baden-Wuerttemberg', 'A total of 17 532 insured persons']",['invitation letter including a FIT (n = 5850); (B) an invitation letter including an option to request a FIT'],"['FIT positivity rate', 'advanced neoplasia', 'use of a FIT within 1 year of the date of the invitation letter']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]",17532.0,0.0690682,Reminders increased usage in group A by 7.5% points and in group B by 8.5% points.,"[{'ForeName': 'Laura Fiona', 'Initials': 'LF', 'LastName': 'Gruner', 'Affiliation': 'Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg; Medical Faculty Heidelberg, University of Heidelberg; Gastroenterologische Schwerpunktpraxis, Dornstadt; AOK Baden-Wuerttemberg, Stuttgart; Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg; German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Heidelberg.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoffmeister', 'Affiliation': ''}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Ludwig', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Meny', 'Affiliation': ''}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Brenner', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0423']
1908,32888250,Impact of an Internet-Based Lifestyle Intervention on Behavioral and Psychosocial Factors During Postpartum Weight Loss.,"OBJECTIVE


This cluster randomized trial tested whether an effective internet-based weight-loss intervention for low-income, postpartum women resulted in greater improvements in targeted social cognitive theory (SCT) constructs and psychosocial outcomes.
METHODS


Fit Moms/Mamás Activas was a 12-month cluster randomized controlled trial of 370 postpartum women at 12 Special Supplemental Nutrition Program for Women, Infants, Children (WIC) clinics that were randomly assigned to intervention or standard WIC. SCT constructs (weight-control behaviors, cognitive restraint, disinhibition, self-efficacy, social support, body image) and psychosocial outcomes (depressive symptoms and stress) were measured at study entry and after 6 and 12 months.
RESULTS


The intervention versus standard WIC resulted in greater 12-month increases in weight-control behaviors (3.28 points [95% CI: 1.06-5.50]), self-monitoring of weight and eating (2.28 points [1.17-3.40]), and cognitive restraint (1.93 points [0.78-3.08]) (all P ≤ 0.004). The intervention effect was only modestly (η p   2   = 0.02) mediated by improvements in these factors. No significant group by time effect was observed for disinhibition, self-efficacy, social support, body image, depressive symptoms, or stress.
CONCLUSIONS


Among low-income postpartum women, an effective internet-based weight-loss program resulted in improved weight-control behaviors and cognitive restraint but did not affect other SCT targets and psychosocial outcomes.",2020,"No significant group by time effect was observed for disinhibition, self-efficacy, social support, body image, depressive symptoms, or stress.
","['370 postpartum women at 12 Special Supplemental Nutrition Program for Women, Infants, Children (WIC) clinics', 'Fit']","['intervention or standard WIC', 'effective internet-based weight-loss intervention', 'Internet-Based Lifestyle Intervention']","['weight-control behaviors', 'SCT constructs (weight-control behaviors, cognitive restraint, disinhibition, self-efficacy, social support, body image) and psychosocial outcomes (depressive symptoms and stress', 'self-monitoring of weight and eating', 'disinhibition, self-efficacy, social support, body image, depressive symptoms, or stress', 'weight-control behaviors and cognitive restraint', 'cognitive restraint']","[{'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C1321111', 'cui_str': 'Weight control behavior'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",370.0,0.0593458,"No significant group by time effect was observed for disinhibition, self-efficacy, social support, body image, depressive symptoms, or stress.
","[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Bennion', 'Affiliation': 'Department of Psychology and Child Development, California Polytechnic State University, San Luis Obispo, California, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Tate', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Muñoz-Christian', 'Affiliation': 'Center for Health Research, California Polytechnic State University, San Luis Obispo, California, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Center for Health Research, California Polytechnic State University, San Luis Obispo, California, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22921']
1909,32888788,"Lowering of hemoglobin A1C and risk of cardiovascular outcomes and all-cause mortality, a meta-regression analysis.","BACKGROUND


The management of type 2 diabetes predominantly focuses on reducing hemoglobin A1C (HbA1c). We examined the association between the magnitude of reduction in HbA1c and cardiovascular outcomes for new diabetes medications: sodium-glucose cotransporter-2 [SGLT2] inhibitors, glucagon-like peptide-1 [GLP1] agonists, and dipeptidyl peptidase-4 [DPP4] inhibitors.
METHODS


We reviewed all published, placebo-controlled, randomized cardiovascular outcome trials. Meta-regression was performed to evaluate the association between HbA1c reduction (i.e., [post-intervention HbA1c for active drug - pre-intervention HbA1c for active drug] - [post-intervention HbA1c for placebo - pre-intervention HbA1c for placebo]) and the composite cardiovascular outcome (i.e., stroke, myocardial infarction, or cardiovascular death).
RESULTS


We identified 14 cardiovascular outcome clinical trials, the median sample size was 9401, the median age was 64 years, the median time since diagnosis of diabetes was 12 years, and the median duration of trial follow-up was 120 weeks. Within individual medication classes, each additional 0.5% reduction in HbA1c in the active drug arm, relative to placebo, was associated with a lower incidence of cardiovascular events for GLP1 agonists (0.82, 0.68-0.98) but not for SGLT2 (0.97, 0.69-1.36) or DPP4 (1.03, 0.39-2.74) inhibitors.
DISCUSSION


Our study provides further support that reducing the risk of cardiovascular events for adults with diabetes is partly explained by a reduction in HbA1c.",2020,"Within individual medication classes, each additional 0.5% reduction in HbA1c in the active drug arm, relative to placebo, was associated with a lower incidence of cardiovascular events for GLP1 agonists (0.82, 0.68-0.98) but not for SGLT2 (0.97, 0.69-1.36) or DPP4 (1.03, 0.39-2.74) inhibitors.
","['adults with diabetes', 'new diabetes medications', 'median sample size was 9401, the median age was 64\u202fyears, the median time since diagnosis of diabetes was 12\u202fyears, and the median duration of trial follow-up was 120\u202fweeks']","['placebo', 'active drug - pre-intervention HbA1c for active drug] - [post-intervention HbA1c for placebo - pre-intervention HbA1c for placebo', 'sodium-glucose cotransporter-2']","['composite cardiovascular outcome (i.e., stroke, myocardial infarction, or cardiovascular death', 'Lowering of hemoglobin A1C and risk of cardiovascular outcomes', 'risk of cardiovascular events', 'hemoglobin A1C (HbA1c', 'cardiovascular events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.197082,"Within individual medication classes, each additional 0.5% reduction in HbA1c in the active drug arm, relative to placebo, was associated with a lower incidence of cardiovascular events for GLP1 agonists (0.82, 0.68-0.98) but not for SGLT2 (0.97, 0.69-1.36) or DPP4 (1.03, 0.39-2.74) inhibitors.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fralick', 'Affiliation': 'Sinai Health System and the Department of Medicine, University of Toronto, Toronto, ON, Canada; University of Toronto, Department of Medicine, General Internal Medicine, Toronto, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Colacci', 'Affiliation': 'University of Toronto, Department of Medicine, General Internal Medicine, Toronto, Canada. Electronic address: Michael.colacci@mail.utoronto.ca.'}, {'ForeName': 'Ayodele', 'Initials': 'A', 'LastName': 'Odutayo', 'Affiliation': ""University of Toronto, Department of Medicine, General Internal Medicine, Toronto, Canada; Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Reed', 'Initials': 'R', 'LastName': 'Siemieniuk', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107704']
1910,32898346,A Randomized Controlled Feasibility Trial of Reminder-Focused Positive Psychiatry in Adolescents With Comorbid Attention-Deficit/Hyperactivity Disorder and Posttraumatic Stress Disorder.,"Objective


To investigate the impact of reminder-focused positive psychiatry (RFPP) on attention-deficit/hyperactive disorder (ADHD) and posttraumatic stress disorder (PTSD) symptoms, vascular-function, inflammation and well-being of adolescents with comorbid ADHD and PTSD.
Methods


After obtaining informed-consent, 11 adolescents were randomized to RFPP (n = 5) or trauma-focused cognitive-behavioral therapy (TF-CBT) (n = 6). Eight participants (RFPP: n = 4, TF-CBT: n = 4) completed the twice-weekly intervention for a 6-week trial. The RFPP intervention was inclusive of positive psychiatry interventions on (1) traumatic reminders and (2) avoidance and negative cognition. Vascular function measured as temperature rebound, C-reactive protein, homocysteine, ADHD Swanson, Nolan, and Pelham (SNAP) Questionnaire, Clinician-Administered PTSD Scale for DSM-5-Child/Adolescent Version (CAPS-CA), and neuropsychiatric-measures were measured at baseline and 6 weeks. Subjects were followed for 12 months. The study was conducted from September 2016 to June 2018.
Results


A significant improvement in CAPS-CA, SNAP scores, and vascular function of both RFPP and TF-CBT groups was noted at follow-up, but was more-robust in the RFPP group (P < .05). At the sixth week, a significant increase in PERMA, gratitude, resilience, and Posttraumatic Growth Inventory scores and a significant decrease in homocysteine and C-reactive protein levels in the RFPP group, but not the TF-CBT group, were noted (P < .05). At 12-month follow-up, there was no psychiatry hospitalization or suicide ideation reported in either group. A continuation of significant improvement in CAPS-CA and SNAP scores in both groups was noted but was more robust in the RFPP group (P < .05). Similarly, a continuation of significant increase in PERMA, gratitude, resilience and Posttraumatic Growth Inventory scores was noted in the RFPP group but not in the TF-CBT group (P < .05).
Conclusions


RFPP is associated with improvement in core PTSD and ADHD symptoms, decrease in inflammation, and increase in well-being, vascular function, and posttraumatic growth, as well as a favorable long-term clinical outcome. This finding highlights the importance of the dual role of RFPP in addressing vulnerability symptoms as well as enhancing well-being in youth with comorbid ADHD and PTSD.
Trial Registration


ClinicalTrials.gov identifier: NCT04336072.",2020,"A significant improvement in CAPS-CA, SNAP scores, and vascular function of both RFPP and TF-CBT groups was noted at follow-up, but was more-robust in the RFPP group (P < .05).","['Eight participants (RFPP: n = 4, TF-CBT: n = 4', 'Adolescents With Comorbid Attention-Deficit/Hyperactivity Disorder and Posttraumatic Stress Disorder', 'adolescents with comorbid ADHD and PTSD.\nMethods\n\n\nAfter obtaining informed-consent, 11 adolescents', 'September 2016 to June 2018']","['trauma-focused cognitive-behavioral therapy (TF-CBT', 'reminder-focused positive psychiatry (RFPP', 'TF-CBT', 'Reminder-Focused Positive Psychiatry', 'RFPP']","['PERMA, gratitude, resilience, and Posttraumatic Growth Inventory scores', 'psychiatry hospitalization or suicide ideation', 'PERMA, gratitude, resilience and Posttraumatic Growth Inventory scores', 'CAPS-CA, SNAP scores, and vascular function', 'inflammation, and increase in well-being, vascular function, and posttraumatic growth', 'Vascular function measured as temperature rebound, C-reactive protein, homocysteine, ADHD Swanson, Nolan, and Pelham', 'homocysteine and C-reactive protein levels', 'SNAP) Questionnaire, Clinician-Administered PTSD Scale for DSM-5-Child/Adolescent Version (CAPS-CA), and neuropsychiatric-measures', 'CAPS-CA and SNAP scores']","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",11.0,0.0339503,"A significant improvement in CAPS-CA, SNAP scores, and vascular function of both RFPP and TF-CBT groups was noted at follow-up, but was more-robust in the RFPP group (P < .05).","[{'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Olive View UCLA Medical Ctr, 1445 Olive View Dr, Sylmar, CA 91342. ahmadi@ucla.edu.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Psychiatry, Kern Medical, Bakersfield, California, USA.'}, {'ForeName': 'Towhid', 'Initials': 'T', 'LastName': 'Salam', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychiatry, Kern Medical, Bakersfield, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kase', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Olango', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Molla', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McCracken', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pynoos', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}]",The primary care companion for CNS disorders,['10.4088/PCC.19m02579']
1911,32914838,Evaluation of a Text Messaging-Based Human Papillomavirus Vaccination Intervention for Young Sexual Minority Men: Results from a Pilot Randomized Controlled Trial.,"BACKGROUND


Men who have sex with men (MSM) are at high risk for human papillomavirus (HPV) infection and HPV-related anal cancer. Although a safe and effective vaccine is available to prevent HPV infection, HPV vaccine uptake among young MSM remains low.
PURPOSE


This pilot randomized controlled trial tested the acceptability, feasibility, and preliminary efficacy of a text messaging-based HPV vaccination intervention for young sexual minority men.
METHODS


In 2018, unvaccinated sexual minority men aged 18-25 years were recruited from Chicago to participate in a 9 month sexual health program called txt2protect. Participants (N = 150) were randomized to the intervention or control condition. Intervention condition messages focused primarily on HPV vaccination, with only a brief mention of other sexual health practices (e.g., condom use and HIV testing), while control condition messages focused on a variety of sexual health practices with only a brief mention of HPV vaccination. Participants received daily text messages for the first 3 weeks and monthly text messages for the remaining ~8 months of the trial. Participants completed surveys at baseline and 3 week and 9 month follow-ups.
RESULTS


Participants reported high satisfaction with the intervention. Although trial retention was high (with over 88% completing the 9 month survey), the study fell short of meeting its recruitment goal. HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%), odds ratio = 3.43, 95% confidence interval: 1.17, 10.08.
CONCLUSIONS


Findings suggest that txt2protect is an acceptable and potentially promising intervention for increasing HPV vaccine initiation among young sexual minority men.
CLINICAL TRIAL REGISTRATION


NCT02994108.",2020,HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%),"['young sexual minority men', 'Participants (N = 150', 'Young Sexual Minority Men', '2018, unvaccinated sexual minority men aged 18-25 years were recruited from Chicago to participate in a 9 month sexual health program called txt2protect', 'Men who have sex with men (MSM']","['Intervention condition messages focused primarily on HPV vaccination, with only a brief mention of other sexual health practices (e.g., condom use and HIV testing), while control condition messages focused on a variety of sexual health practices with only a brief mention of HPV vaccination', 'Text Messaging-Based Human Papillomavirus Vaccination Intervention', 'text messaging-based HPV vaccination intervention']",['HPV vaccine series initiation'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",150.0,0.217267,HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%),"[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Gerend', 'Affiliation': 'Department of Behavioral Sciences and Social Medicine, College of Medicine, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Madkins', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Shariell', 'Initials': 'S', 'LastName': 'Crosby', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Korpak', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Phillips', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bass', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Houlberg', 'Affiliation': 'Howard Brown Health, Chicago, IL, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa056']
1912,32880572,Six versus 12 months' adjuvant trastuzumab in patients with HER2-positive early breast cancer: the PERSEPHONE non-inferiority RCT.,"BACKGROUND


The addition of adjuvant trastuzumab to chemotherapy has significantly improved outcomes for people with human epidermal growth factor receptor 2 (HER2)-positive, early, potentially curable breast cancer. Twelve months' trastuzumab, tested in registration trials, was adopted as standard adjuvant treatment in 2006. Subsequently, similar outcomes were demonstrated using 9 weeks of trastuzumab. Shorter durations were therefore tested for non-inferiority.
OBJECTIVES


To establish whether or not 6 months' adjuvant trastuzumab is non-inferior to 12 months' in the treatment of HER2-positive early breast cancer using a primary end point of 4-year disease-free survival.
DESIGN


This was a Phase III randomised controlled non-inferiority trial.
SETTING


The setting was 152 NHS hospitals.
PARTICIPANTS


A total of 4088 patients with HER2-positive early breast cancer who it was planned would receive both chemotherapy and trastuzumab took part.
INTERVENTION


Randomisation (1 : 1) to 6 months' or 12 months' trastuzumab treatment.
MAIN OUTCOMES


The primary end point was disease-free survival. The secondary end points were overall survival, cost-effectiveness and cardiac function during treatment with trastuzumab. Assuming a 4-year disease-free survival rate of 80% with 12 months' trastuzumab, 4000 patients were required to demonstrate non-inferiority of 6 months' trastuzumab (5% one-sided significance, 85% power), defining the non-inferiority limit as no worse than 3% below the standard arm. Costs and quality-adjusted life-years were estimated using a within-trial analysis and a lifetime decision-analytic model.
RESULTS


Between 4 October 2007 and 31 July 2015, 2045 patients were randomised to 12 months' trastuzumab and 2043 were randomised to 6 months' trastuzumab. Sixty-nine per cent of patients had ER-positive disease; 90% received anthracyclines (49% with taxanes; 41% without taxanes); 10% received taxanes without anthracyclines; 54% received trastuzumab sequentially after chemotherapy; and 85% received adjuvant chemotherapy (58% were node negative). At 6.1 years' median follow-up, with 389 (10%) deaths and 566 (14%) disease-free survival events, the 4-year disease-free survival rates for the 4088 patients were 89.5% (95% confidence interval 88.1% to 90.8%) in the 6-month group and 90.3% (95% confidence interval 88.9% to 91.5%) in the 12-month group (hazard ratio 1.10, 90% confidence interval 0.96 to 1.26; non-inferiority  p  = 0.01), demonstrating non-inferiority of 6 months' trastuzumab. Congruent results were found for overall survival (non-inferiority  p  = 0.0003) and landmark analyses 6 months from starting trastuzumab [non-inferiority  p  = 0.03 (disease-free-survival) and  p  = 0.006 (overall survival)]. Six months' trastuzumab resulted in fewer patients reporting adverse events of severe grade [365/1929 (19%) vs. 460/1935 (24%) for 12-month patients;  p  = 0.0003] or stopping early because of cardiotoxicity [61/1977 (3%) vs. 146/1941 (8%) for 12-month patients;  p  < 0.0001]. Health economic analysis showed that 6 months' trastuzumab resulted in significantly lower lifetime costs than and similar lifetime quality-adjusted life-years to 12 months' trastuzumab, and thus there is a high probability that 6 months' trastuzumab is cost-effective compared with 12 months' trastuzumab. Patient-reported experiences in the trial highlighted fatigue and aches and pains most frequently.
LIMITATIONS


The type of chemotherapy and timing of trastuzumab changed during the recruitment phase of the study as standard practice altered.
CONCLUSIONS


PERSEPHONE demonstrated that, in the treatment of HER2-positive early breast cancer, 6 months' adjuvant trastuzumab is non-inferior to 12 months'. Six months' treatment resulted in significantly less cardiac toxicity and fewer severe adverse events.
FUTURE WORK


Ongoing translational work investigates patient and tumour genetic determinants of toxicity, and trastuzumab efficacy. An individual patient data meta-analysis with PHARE and other trastuzumab duration trials is planned.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN52968807, EudraCT 2006-007018-39 and ClinicalTrials.gov NCT00712140.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 40. See the NIHR Journals Library website for further project information.",2020,Congruent results were found for overall survival (non-inferiority  p  = 0.0003) and landmark analyses 6 months from starting trastuzumab [non-inferiority  p  = 0.03 (disease-free-survival) and  p  = 0.006 (overall survival)].,"['patients with HER2-positive early breast cancer', 'people with human epidermal growth factor receptor 2 (HER2)-positive, early, potentially curable breast cancer', 'Between 4 October 2007 and 31 July 2015, 2045 patients were randomised to 12 months', 'A total of 4088 patients with HER2-positive early breast cancer who it was planned would receive both chemotherapy and trastuzumab took part']","['adjuvant trastuzumab', 'trastuzumab', 'anthracyclines', 'adjuvant chemotherapy', 'trastuzumab sequentially after chemotherapy', 'taxanes without anthracyclines', 'trastuzumab treatment']","['4-year disease-free survival rate', 'lifetime costs', 'Costs and quality-adjusted life-years', 'adverse events of severe grade', 'disease-free survival', 'overall survival, cost-effectiveness and cardiac function', 'cardiac toxicity', 'disease-free survival events, the 4-year disease-free survival rates', 'severe adverse events', 'cardiotoxicity', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0449719', 'cui_str': 'Part'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",4088.0,0.282781,Congruent results were found for overall survival (non-inferiority  p  = 0.0003) and landmark analyses 6 months from starting trastuzumab [non-inferiority  p  = 0.03 (disease-free-survival) and  p  = 0.006 (overall survival)].,"[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Earl', 'Affiliation': ""Department of Oncology, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hiller', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Vallier', 'Affiliation': 'Cambridge Clinical Trials Unit - Cancer Theme, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Shrushma', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McAdam', 'Affiliation': 'Department of Oncology, North West Anglia NHS Foundation Trust, Peterborough City Hospital, Peterborough, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Hughes-Davies', 'Affiliation': ""Department of Oncology, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rea', 'Affiliation': 'Cancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Howe', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Raynes', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen B', 'Initials': 'HB', 'LastName': 'Higgins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Wilcox', 'Affiliation': ""Independent Cancer Patients' Voice, London, UK.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Plummer', 'Affiliation': 'Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Betania', 'Initials': 'B', 'LastName': 'Mahler-Araujo', 'Affiliation': 'Department of Histopathology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Provenzano', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre, Cambridge, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': ""Pharmacy, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gasson', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Balmer', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Jean E', 'Initials': 'JE', 'LastName': 'Abraham', 'Affiliation': ""Department of Oncology, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Caldas', 'Affiliation': ""Department of Oncology, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Edinburgh University Cancer Research Centre, Institute of Genetics and Molecular Medicine, University of Edinburgh, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Shinkins', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Institute of Health Economics, Edmonton, AB, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Wardley', 'Affiliation': 'NIHR Manchester Clinical Research Facility at The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cameron', 'Affiliation': 'Edinburgh University Cancer Research Centre, Institute of Genetics and Molecular Medicine, University of Edinburgh, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24400']
1913,32878400,[Clinical observation of three-dimensional printing donor tooth model in peri-operative period of autotransplantation of tooth].,"Objective:  To prepare a three-dimensional (3D) printing donor tooth model and to observe its application in the peri-operative period.  Methods:  In part one, 192 cases (2017.9-2019.8) from Department of Oral & Maxillofacial Surgery, School of Stomatology, The Fourth Military Medical University ［107 males and 85 females, age (34.2±10.7) years］ which need autotransplantation of teeth (ATT) were collected. Whether the donor teeth can be completely extracted was predicted through clinical and imaging examination (first prediction). The second prediction was supplemented by the three-dimensional printing model of the donor teeth. Each of the prediction was compared with the actual results and the coincidence rate was calculated. In part two, 64 cases (2017.9-2019.8) from Department of Oral & Maxillofacial Surgery, School of Stomatology, The Fourth Military Medical University ［28 males, 36 females, age (30.2±8.3) years］ which need ATT were randomly divided into the model group and the donor group. The time of alveolar fossa preparation, time of donor tooth  in vitro , times of trial implantation and time of pulptomy and root canal location were recorded respectively.  Results:  In part one, the coincidence rate between the second prediction and the actual results ［97.4%(187/192)］ was significantly higher than that of the first prediction ［93.2%(179/192)］ ( P <0.05). In part two, the preparation time of the alveolar fossa in the maxillary and mandibular were (18.8±4.6) and (22.7±3.4) min, the time of the teeth  in vitro  were (3.0±0.6) and (2.1±0.6) min, the times of trial implantation were (1.3±0.8) and (1.0±0.9), and the time of pulpotomy and root canal location were (4.3±0.6) and (4.0±0.5) min. All values in the model groups were better than those in the donor group ( P <0.05).  Conclusions:  The 3D printing model is accurate. It can be used in autogenous tooth transplantation to shorten the preparation time of alveolar fossa and time of donor tooth  in vitro , and reduce the times of trial implantation of donor teeth, and to help to improve the prediction accuracy of complete extraction of donor teeth and the time of pulpotomy and root canal location.",2020,All values in the model groups were better than those in the donor group ( P <0.05).  ,"['In part one, 192 cases (2017.9-2019.8) from Department of Oral & Maxillofacial Surgery, School of Stomatology, The Fourth Military Medical University ［107 males and 85 females, age (34.2±10.7) years］ which need autotransplantation of teeth (ATT) were collected', 'In part two, 64 cases (2017.9-2019.8) from Department of Oral & Maxillofacial Surgery, School of Stomatology, The Fourth Military Medical University ［28 males, 36 females, age (30.2±8.3) years］ which need ATT', 'peri-operative period of autotransplantation of tooth']",[],"['time of the teeth  in vitro', 'time of alveolar fossa preparation, time of donor tooth  in vitro , times of trial implantation and time of pulptomy and root canal location', 'time of pulpotomy and root canal location', 'coincidence rate']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0029167', 'cui_str': 'Medicine, Oral'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0398926', 'cui_str': 'Autotransplantation of tooth'}, {'cui': 'C3886195', 'cui_str': '2-amino-5-mercapto-1,3,4-thiadiazole'}, {'cui': 'C0347985', 'cui_str': 'During values'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0325079', 'cui_str': 'Cryptoprocta ferox'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}]",,0.0208612,All values in the model groups were better than those in the donor group ( P <0.05).  ,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hou', 'Affiliation': ""Department of Oral & Maxillofacial Surgery, School of Stomatology, The Fourth Military Medical University & State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Xi'an 710032, China.""}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Hui', 'Affiliation': ""Department of Oral & Maxillofacial Surgery, School of Stomatology, The Fourth Military Medical University & State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Xi'an 710032, China.""}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Xu', 'Affiliation': ""Department of Oral & Maxillofacial Surgery, School of Stomatology, The Fourth Military Medical University & State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Xi'an 710032, China.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ""Department of Oral & Maxillofacial Surgery, School of Stomatology, The Fourth Military Medical University & State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Xi'an 710032, China.""}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Wang', 'Affiliation': ""Department of Operative Dentistry & Endodontics, School of Stomatology, The Fourth Military Medical University & State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Key Laboratory of Stomatology, Xi'an 710032, China.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': ""Department of Operative Dentistry & Endodontics, School of Stomatology, The Fourth Military Medical University & State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Key Laboratory of Stomatology, Xi'an 710032, China.""}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Liu', 'Affiliation': ""Department of General Dentistry and Emergency, School of Stomatology, The Fourth Military Medical University & State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi International Joint Research Center for Oral Diseases, Xi'an 710032, China.""}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Zhu', 'Affiliation': ""Department of General Dentistry and Emergency, School of Stomatology, The Fourth Military Medical University & State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi International Joint Research Center for Oral Diseases, Xi'an 710032, China.""}, {'ForeName': 'H Z', 'Initials': 'HZ', 'LastName': 'Zhou', 'Affiliation': ""Department of Oral & Maxillofacial Surgery, School of Stomatology, The Fourth Military Medical University & State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Xi'an 710032, China.""}]",Zhonghua kou qiang yi xue za zhi = Zhonghua kouqiang yixue zazhi = Chinese journal of stomatology,['10.3760/cma.j.cn112144-20200204-00033']
1914,32885274,An evaluation of overall survival in patients with newly diagnosed acute myeloid leukemia and the relationship with glasdegib treatment and exposure.,"PURPOSE


Glasdegib, an oral inhibitor of the Hedgehog signaling pathway, is approved in the United States in combination with low-dose cytarabine (LDAC) to treat patients with newly diagnosed acute myeloid leukemia (AML) ineligible to receive intensive chemotherapy. This population pharmacokinetic/pharmacodynamic analysis characterized the time course of survival with glasdegib + LDAC relative to LDAC alone, and explored whether the differences in glasdegib exposure at the clinical dose of 100 mg once daily (QD) significantly affected overall survival (OS).
METHODS


Data from the BRIGHT AML 1003 trial in patients with AML were included in treatment-response (glasdegib + LDAC, n = 78; LDAC alone, n = 38) and exposure-response (glasdegib + LDAC, n = 75) analyses.
RESULTS


The analyses demonstrate that patients treated with glasdegib + LDAC (vs LDAC alone) at any time point during the study period were 58% less likely to die, translating to prolonging of median OS by ~ 5 months (hazard ratio 0.42 [95% confidence interval 0.28-0.66]). Variability in glasdegib exposures did not impact the risk of death. Additionally, potential covariates such as patient demographics, prior treatment with a hypomethylating agent, baseline safety laboratory values, and disease characteristics, did not impact the probability of OS.
CONCLUSION


Together these results confirm that glasdegib + LDAC treatment (vs. LDAC alone) is associated with a significant survival benefit in patients with newly diagnosed AML, and that variability in glasdegib doses (e.g., for dose reductions) and exposures do not compromise the survival benefit of glasdegib 100 mg QD.
CLINICAL TRIAL NUMBER


NCT01546038.",2020,Variability in glasdegib exposures did not impact the risk of death.,"['patients with newly diagnosed AML', 'patients with AML were included in treatment-response (glasdegib\u2009+\u2009LDAC, n\u2009=\u200978', 'patients with newly diagnosed acute myeloid leukemia and the relationship with glasdegib treatment and exposure', 'patients with newly diagnosed acute myeloid leukemia (AML) ineligible to receive']","['glasdegib\u2009+\u2009LDAC', 'LDAC alone, n\u2009=\u200938) and exposure-response (glasdegib\u2009+\u2009LDAC, n\u2009=\u200975) analyses', 'intensive chemotherapy', 'cytarabine (LDAC']","['overall survival (OS', 'prolonging of median OS', 'risk of death', 'survival benefit', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.422954,Variability in glasdegib exposures did not impact the risk of death.,"[{'ForeName': 'Swan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Clinical Pharmacology, Global Product Development, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92121, USA. swan.lin@pfizer.com.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Shaik', 'Affiliation': 'Clinical Pharmacology, Global Product Development, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92121, USA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Oncology, Global Product Development, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta, GA, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ruiz-Garcia', 'Affiliation': 'Clinical Pharmacology, Global Product Development, Pfizer Inc, 10555 Science Center Dr, San Diego, CA, 92121, USA.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04132-x']
1915,32886070,The Atrial Fibrillation Health Literacy Information Technology Trial: Pilot Trial of a Mobile Health App for Atrial Fibrillation.,"BACKGROUND


Atrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence.
OBJECTIVE


This study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence.
METHODS


Participants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants' use and acceptability of the intervention.
RESULTS


A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; P<.001). Qualitative assessments of acceptability identified that participants found the relational agent useful, informative, and trustworthy.
CONCLUSIONS


Individuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.",2020,The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days.,"['Participants were recruited from ambulatory clinics and randomized to a', 'A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women', 'individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring']","['30-day intervention or usual care', 'smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring']","['daily activity', 'acceptability and adherence', 'HRQoL and adherence', 'AFEQT and adherence', 'self-reported adherence to anticoagulation therapy', 'total AFEQT scores', 'Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",120.0,0.139244,The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Guhl', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Althouse', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Pusateri', 'Affiliation': 'School of Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Everlyne', 'Initials': 'E', 'LastName': 'Kimani', 'Affiliation': 'College of Computer and Information Science, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Paasche-Orlow', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, Boston University, Boston, MA, United States.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Bickmore', 'Affiliation': 'College of Computer and Information Science, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Jared W', 'Initials': 'JW', 'LastName': 'Magnani', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}]",JMIR cardio,['10.2196/17162']
1916,32888031,Effects of acetaminophen on risk taking.,"Acetaminophen, an analgesic and antipyretic available over-the-counter and used in over 600 medicines, is one of the most consumed drugs in the USA. Recent research has suggested that acetaminophen's effects extend to the blunting of negative as well as positive affect. Because affect is a determinant of risk perception and risk taking, we tested the hypothesis that acute acetaminophen consumption (1000 mg) could influence these important judgments and decisions. In three double-blind, placebo-controlled studies, healthy young adults completed a laboratory measure of risk taking (Balloon Analog Risk Task) and in Studies 1 and 2 completed self-report measures of risk perception. Across all studies (total n = 545), acetaminophen increased risk-taking behavior. On the more affectively stimulating risk perception measure used in Study 2, acetaminophen reduced self-reported perceived risk and this reduction statistically mediated increased risk-taking behavior. These results indicate that acetaminophen can increase risk taking, which may be due to reductions in risk perceptions, particularly those that are highly affect laden.",2020,"Across all studies (total n = 545), acetaminophen increased risk-taking behavior.",['healthy young adults'],"['acetaminophen', 'Acetaminophen', 'placebo']","['risk-taking behavior', 'risk taking', 'risk taking (Balloon Analog Risk Task']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}]",,0.0431866,"Across all studies (total n = 545), acetaminophen increased risk-taking behavior.","[{'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Keaveney', 'Affiliation': 'Department of Psychology, The Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Peters', 'Affiliation': 'School of Journalism and Communication, University of Oregon Eugene, OR 97403, USA.'}, {'ForeName': 'Baldwin', 'Initials': 'B', 'LastName': 'Way', 'Affiliation': 'Department of Psychology, The Ohio State University, Columbus, OH 43210, USA.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa108']
1917,32889091,A novel CNN algorithm for pathological complete response prediction using an I-SPY TRIAL breast MRI database.,"PURPOSE


To apply our convolutional neural network (CNN) algorithm to predict neoadjuvant chemotherapy (NAC) response using the I-SPY TRIAL breast MRI dataset.
METHODS


From the I-SPY TRIAL breast MRI database, 131 patients from 9 institutions were successfully downloaded for analysis. First post-contrast MRI images were used for 3D segmentation using 3D slicer. Our CNN was implemented entirely of 3 × 3 convolutional kernels and linear layers. The convolutional kernels consisted of 6 residual layers, totaling 12 convolutional layers. Dropout with a 0.5 keep probability and L2 normalization was utilized. Training was implemented by using the Adam optimizer. A 5-fold cross validation was used for performance evaluation. Software code was written in Python using the TensorFlow module on a Linux workstation with one NVidia Titan X GPU.
RESULTS


Of 131 patients, 40 patients achieved pCR following NAC (group 1) and 91 patients did not achieve pCR following NAC (group 2). Diagnostic accuracy of our CNN two classification model distinguishing patients with pCR vs non-pCR was 72.5 (SD ± 8.4), with sensitivity 65.5% (SD ± 28.1) and specificity of 78.9% (SD ± 15.2). The area under a ROC Curve (AUC) was 0.72 (SD ± 0.08).
CONCLUSION


It is feasible to use our CNN algorithm to predict NAC response in patients using a multi-institution dataset.",2020,"To apply our convolutional neural network (CNN) algorithm to predict neoadjuvant chemotherapy (NAC) response using the I-SPY TRIAL breast MRI dataset.
","['131 patients', '131 patients from 9 institutions were successfully downloaded for analysis']",['NAC'],"['area under a ROC Curve (AUC', 'Diagnostic accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",131.0,0.036975,"To apply our convolutional neural network (CNN) algorithm to predict neoadjuvant chemotherapy (NAC) response using the I-SPY TRIAL breast MRI dataset.
","[{'ForeName': 'Michael Z', 'Initials': 'MZ', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Physics, Columbia University Medical Center, 177 Ft. Washington Ave., Milstein Bldg Room 3-124B, New York, NY, United States of America. Electronic address: mzl2104@cumc.columbia.edu.'}, {'ForeName': 'Simukayi', 'Initials': 'S', 'LastName': 'Mutasa', 'Affiliation': 'Department of Radiology, Columbia University Medical Center, 622 West 168th Street, PB-1-301, New York, NY, United States of America. Electronic address: stm9116@nyp.org.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chang', 'Affiliation': 'Department of Radiological Sciences, Center for Artificial Intelligence in Diagnostic Medicine (CAIDM), University of California, Irvine, Calit2 Building, Suite 4500, 4100 E. Peltason Drive, Irvine, CA, United States of America. Electronic address: changp6@uci.edu.'}, {'ForeName': 'Maham', 'Initials': 'M', 'LastName': 'Siddique', 'Affiliation': 'Department of Radiology, Columbia University Medical Center, 622 West 168th Street, PB-1-301, New York, NY, United States of America. Electronic address: ms5270@cumc.columbia.edu.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Jambawalikar', 'Affiliation': 'Department of Medical Physics, Columbia University Medical Center, 177 Ft. Washington Ave., Milstein Bldg Room 3-124B, New York, NY, United States of America. Electronic address: sj2532@cumc.columbia.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ha', 'Affiliation': 'Breast Imaging Section, New York Presbyterian Hospital, Columbia University Medical Center, 622 West 168th Street, PB-1-301, New York, NY 10032, United States of America. Electronic address: rh2616@columbia.edu.'}]",Magnetic resonance imaging,['10.1016/j.mri.2020.08.021']
1918,32889444,Evaluating substance use treatment efficacy for younger and older adults.,"The purpose of this study was to examine the differential efficacy of aftercare substance use treatments for younger (below 40, n = 107) versus older (40+, n = 114) adults (N = 221), using data from a randomized controlled trial in a community-based substance abuse treatment center. The younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1. Primary outcomes were rates of abstinence and percent use days at 1-year follow-up. Outcomes were compared between standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU). Results showed significant differences by treatment in the older, but not in younger, subsample of participants. Specifically, the older participants in MBRP had significantly higher abstinence rates compared with those in TAU. Further, the older individuals in MBRP had a significantly lower percent of days on which they used compared with those in TAU and RP. Overall, findings suggest that age group may impact aftercare treatment substance use outcomes.",2020,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","['younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1', 'younger (below 40, n\xa0=\xa0107) versus older (40+, n\xa0=\xa0114) adults (N\xa0=\xa0221), using data from a randomized controlled trial in a community-based substance abuse treatment center', 'younger and older adults']",['aftercare substance'],"['rates of abstinence and percent use days at 1-year follow-up', 'abstinence rates', 'standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079256', 'cui_str': 'Substance abuse treatment center'}]","[{'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",114.0,0.101879,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","[{'ForeName': 'Tyree', 'Initials': 'T', 'LastName': 'Dingle', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States. Electronic address: ding7624@pacificu.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106618']
1919,32886795,Locomotor muscle group III/IV afferents constrain stroke volume and contribute to exercise intolerance in human heart failure.,"KEY POINTS


Heart failure patients with reduced ejection fraction (HFrEF) exhibit severe limitations in exercise capacity (    V   ̇   O   2      peak). One of the primary peripheral mechanisms suggested to underlie exercise intolerance in HFrEF is excessive locomotor muscle group III/IV afferent feedback; however, this has never been investigated in human heart failure. HFrEF patients and controls performed an incremental exercise test to volitional exhaustion to determine    V   ̇   O   2      peak with lumbar intrathecal fentanyl or placebo. During exercise, cardiac output, leg blood flow and radial artery and femoral venous blood gases were measured. With fentanyl, compared with placebo, patients with HFrEF achieved a higher peak workload,    V   ̇   O   2      peak, cardiac output, stroke volume and leg blood flow. These findings suggest that locomotor muscle group III/IV afferent feedback in HFrEF leads to increased systemic vascular resistance, which constrains stroke volume, cardiac output and O 2  delivery thereby impairing    V   ̇   O   2      peak and thus exercise capacity.
ABSTRACT


To better understand the underlying mechanisms contributing to exercise limitation in heart failure with reduced ejection fraction (HFrEF), we investigated the influence of locomotor muscle group III/IV afferent inhibition via lumbar intrathecal fentanyl on peak exercise capacity (    V   ̇   O   2      peak) and the contributory mechanisms. Eleven HFrEF patients and eight healthy matched controls were recruited. The participants performed an incremental exercise test to volitional exhaustion to determine    V   ̇   O   2      peak with lumbar intrathecal fentanyl or placebo. During exercise, cardiac output and leg blood flow (    Q   ̇   L    ) were measured via open-circuit acetylene wash-in technique and constant infusion thermodilution, respectively. Radial artery and femoral venous blood gases were measured.    V   ̇   O   2      peak was 15% greater with fentanyl compared with placebo for HFrEF (P < 0.01), while no different in the controls. During peak exercise with fentanyl, cardiac output was 12% greater in HFrEF secondary to significant decreases in systemic vascular resistance and increases in stroke volume compared with placebo (all, P < 0.01). From placebo to fentanyl, leg    V   ̇   O   2      ,    Q   ̇   L    and O 2  delivery were greater for HFrEF during peak exercise (all, P < 0.01), but not control. These findings indicate that locomotor muscle group III/IV afferent feedback in patients with HFrEF leads to increased systemic vascular resistance, which constrains stroke volume, cardiac output and O 2  delivery, thereby impairing    V   ̇   O   2      peak and thus exercise capacity. These findings have important clinical implications as    V   ̇   O   2      peak is highly predictive of morbidity and mortality in HF.",2020,"Results V̇O 2  peak was 15% greater with fentanyl compared to placebo for HFrEF (p<0.01), while not different in the controls.","['Eleven HFrEF patients and 8 healthy matched controls were recruited', 'Heart failure patients with reduced ejection fraction (HFrEF) exhibit severe limitations in exercise capacity (V̇O 2  peak', 'human heart failure', 'heart failure with reduced ejection fraction (HFrEF']","['fentanyl', 'HFrEF', 'incremental exercise test to volitional exhaustion to determine V̇O 2  peak with lumbar intrathecal fentanyl or placebo', 'placebo', 'Locomotor muscle group III/IV afferents constrain stroke volume']","['systemic vascular resistance', 'peak exercise capacity', 'cardiac output and leg blood flow (Q̇', 'Radial artery and femoral venous blood gases', 'cardiac output, leg blood flow, and radial artery and femoral venous blood gases', 'leg V̇O 2  , Q̇ L  , and O 2  delivery', 'systemic vascular resistance, which constrains stroke volume, cardiac output, and O 2  delivery thereby impairing V̇O 2  peak and thus exercise capacity', 'stroke volume', 'peak workload, V̇O 2  peak, cardiac output, stroke volume, and leg blood flow']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]","[{'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}]",11.0,0.0913429,"Results V̇O 2  peak was 15% greater with fentanyl compared to placebo for HFrEF (p<0.01), while not different in the controls.","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Smith', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Joyner', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Curry', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, MN, USA.'}, {'ForeName': 'Manda L', 'Initials': 'ML', 'LastName': 'Keller-Ross', 'Affiliation': 'Division of Physical Therapy and Rehabilitation Sciences, University of Minnesota, MN, USA.'}, {'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Van Iterson', 'Affiliation': 'Section of Preventative Cardiology and Rehabilitation, Cleveland Clinic, MN, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Olson', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, MN, USA.'}]",The Journal of physiology,['10.1113/JP280333']
1920,32891871,No tDCS augmented working memory training benefit in undergraduates rewarded with course credit.,"BACKGROUND


The goal of working memory (WM) training is to expand capacity of this executive function. Transcranial direct current stimulation (tDCS) paired with WM training is more consistent than either alone. We have reported that tDCS targeting frontal and/or parietal regions enhanced theta phase locking, reduced alpha power, and strengthened theta-gamma phase amplitude coupling.
OBJECTIVE


To determine whether tDCS to frontal or parietal sites optimized WM training gains we pre-registered a tDCS-WM training study.
METHODS


80 undergraduates were randomly assigned to one of four anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4). Participants completed 5-training sessions over one week and returned for follow-up testing after 30 days of no-contact.
RESULTS


No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
CONCLUSIONS


This null finding marks a failure to replicate in undergraduates training benefits observed in graduate students. We argue that motivation is essential to elicit improved performance in training protocols.",2020,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","['graduate students', '80 undergraduates']","['anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4', 'Transcranial direct current stimulation (tDCS) paired with WM training', 'working memory (WM) training']",['trained or transfer task performance'],"[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",80.0,0.033538,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","[{'ForeName': 'Jorja', 'Initials': 'J', 'LastName': 'Shires', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carrasco', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA; University of California, Davis, Program in Neuroscience, Davis, CA, 95616, USA.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Berryhill', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences, Department of Psychology, Reno, NV, 89557, USA. Electronic address: mberryhill@unr.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.08.015']
1921,32891892,A multicenter effectiveness trial of QEEG-informed neurofeedback in ADHD: Replication and treatment prediction.,"INTRODUCTION


Quantitative Electroencephalogram-(QEEG-)informed neurofeedback is a method in which standard neurofeedback protocols are assigned, based on individual EEG characteristics in order to enhance effectiveness. Thus far clinical effectiveness data have only been published in a small sample of 21 ADHD patients. Therefore, this manuscript aims to replicate this effectiveness in a new sample of 114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset and to investigate potential predictors of neurofeedback response.
METHODS


A sample of 114 patients were included as a replication sample. Patients were treated with standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice. The ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI) were assessed at baseline, every 10th session, and at outtake. Holland Sleep Disorder Questionnaire (HSDQ) was assessed at baseline and outtake. Response was defined as ≥25% reduction (R25), ≥50% reduction (R50), and remission. Predictive analyses were focused on predicting remission status.
RESULTS


In the current sample, response rates were 85% (R25), 70% (R50), and remission was 55% and clinical effectiveness was not significantly different from the original 2012 sample. Non-remitters exhibited significantly higher baseline hyperactivity ratings. Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
DISCUSSION


In the current sample, clinical effectiveness was replicated, suggesting it is possible to assign patients to a protocol based on their individual baseline QEEG to enhance signal-to-noise ratio. Furthermore, remitters had lower baseline hyperactivity scores. Likewise, female remitters had shorter P300 latencies, whereas boys who remitted have a lower iAPF. Our data suggests initial specificity in treatment allocation, yet further studies are needed to replicate the predictors of neurofeedback remission.",2020,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","['21 ADHD patients', 'A sample of 114 patients were included as a replication sample', '114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset']","['standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice', 'QEEG']","['Holland Sleep Disorder Questionnaire (HSDQ', 'response rates', 'ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI', 'baseline hyperactivity scores', 'shorter P300 latencies', 'clinical effectiveness', 'baseline hyperactivity ratings']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439743', 'cui_str': 'Multicentric'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",114.0,0.0593453,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","[{'ForeName': 'Noralie', 'Initials': 'N', 'LastName': 'Krepel', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Egtberts', 'Affiliation': 'neuroCare Group Netherlands, Nijmegen, The Netherlands.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Sack', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Heinrich', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; neuroCare Group, Munich, Germany; kbo-Heckscher-Klinikum, Munich, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'neuroCare Group, Sydney, Australia.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; Dept. of Experimental Psychology, Utrecht University, Utrecht, The Netherlands. Electronic address: martijn@brainclinics.com.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102399']
1922,32891918,Working memory moderates the relation between the brain-derived neurotropic factor (BDNF) and psychotherapy outcome for depression.,"BACKGROUND


Insight into patient characteristics that predict response to treatment for major depressive disorder (MDD) may help to personalize treatment and improve outcomes. One mechanism that has been linked to the success of treatment for MDD is brain-derived neurotropic factor (BDNF). BDNF is implicated in learning and memory and may play a role in the effects of psychotherapy that involves changing cognitions and behaviors. In addition, only in individuals with low BDNF, low working memory capacity has been associated with increased symptoms of depression. However, the role of BDNF and working memory capacity in psychotherapy outcome is unclear. The aim of this study was to investigate the role of BDNF and its interaction with working memory capacity in psychotherapy outcomes for MDD.
METHOD


Adult patients with MDD were randomized to weekly or twice weekly sessions of cognitive behavioral therapy or interpersonal psychotherapy. BDNF Val66Met polymorphism (rs6265) (n = 138) was defined and serum BDNF was quantified before (n = 138) and after psychotherapy (n = 82).
RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions. Working memory capacity significantly moderated the relation between baseline serum BDNF and outcome: high serum BDNF at baseline was related to less depressive symptoms following psychotherapy in the presence of high working memory capacity, but not low working memory capacity.
DISCUSSION


These findings, if replicated, might indicate that while BDNF may not be related to psychotherapy outcomes in general, they may play a role in the presence of specific learning processes such as working memory capacity.",2020,"RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions.","['Adult patients with MDD', 'major depressive disorder (MDD']","['cognitive behavioral therapy or interpersonal psychotherapy', 'BDNF', 'brain-derived neurotropic factor (BDNF) and psychotherapy']","['serum BDNF', 'depressive symptoms', 'Baseline serum BDNF and the Val66Met polymorphism']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]",138.0,0.0539135,"RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions.","[{'ForeName': 'Sanne J E', 'Initials': 'SJE', 'LastName': 'Bruijniks', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands; Department of Clinical Psychology and Psychotherapy, University of Freiburg, Freiburg, Germany. Electronic address: sanne.bruijniks@psychologie.uni-freiburg.de.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Grootheest', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'de Kluiver', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Christiaan H', 'Initials': 'CH', 'LastName': 'Vinkers', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; Department of Anatomy and Neurosciences, Amsterdam University Medical Center, Amsterdam Neuroscience, Amsterdam, the Netherlands.'}, {'ForeName': 'Frenk', 'Initials': 'F', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Penninx', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Teunissen', 'Affiliation': 'Neurochemistry Lab, Department of Clinical Chemistry, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam Neuroscience, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, Philadelphia, United States.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.045']
1923,32890472,Do Antimicrobial Photodynamic Therapy and Low-Level Laser Therapy Minimize Postoperative Pain and Edema After Molar Extraction?,"PURPOSE


This study was designed to examine the efficacy of antimicrobial photodynamic therapy (aPDT) and low-level laser therapy (LLLT) in reducing postoperative pain and edema after molar extractions.
METHODS


The investigators designed a single-blind randomized controlled study and enrolled subjects requiring extraction of at least one of the first or second molars. They were randomized to one of the following four groups: control group, aPDT group, LLLT group, and aPDT and LLLT group. Patients were blinded to the group assigned. The outcome variables were postoperative pain and edema. Pain intensity was measured on a visual analog scale (recorded every day for 7 days after tooth extraction). Facial edema was assessed by measuring the perimeter between the tragus, base of the jaw, and labial commissure, which was recorded once before surgery and then on the third and seventh days after surgery. Other variables were age, sex, ethnicity, decayed/missing/filled teeth, and tooth types. Appropriate univariate and bivariate statistics were computed and statistical significance was set at a value of P < .05.
RESULTS


The sample was composed of 40 patients with a mean age of 41.25 ± 13.97 years and 25 (62.5%) of them were women. There were 10 subjects in each treatment group. The mean of postoperative pain within the groups was associated with a significant continuous decrease over time (P < .05). Postoperative pain was lowest in the aPDT + LLLT group in the 1st, 2nd, 3rd, 5th, 6th, and 7th day after tooth extraction (P < .05). There were no significant differences in edema among the groups (P > .05).
CONCLUSION


The combined use of aPDT and LLLT was effective in reducing postoperative pain. These procedures can be applied in everyday surgical practice.",2020,The mean of postoperative pain within the groups was associated with a significant continuous decrease over time (P < .05).,"['40 patients with a mean age of 41.25\xa0±\xa013.97 years and 25 (62.5%) of them were women', 'enrolled subjects requiring extraction of at least one of the first or second\xa0molars']","['antimicrobial photodynamic therapy (aPDT) and low-level laser therapy (LLLT', 'aPDT\xa0+\xa0LLLT', 'aPDT and LLLT', 'control group, aPDT group, LLLT', 'Antimicrobial Photodynamic Therapy and Low-Level Laser Therapy']","['visual analog scale', 'edema', 'mean of postoperative pain', 'postoperative pain and edema', 'postoperative pain', 'Pain intensity', 'Postoperative pain', 'Facial edema', 'Postoperative Pain and Edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0542571', 'cui_str': 'Edema of face'}]",40.0,0.0341872,The mean of postoperative pain within the groups was associated with a significant continuous decrease over time (P < .05).,"[{'ForeName': 'Renato Silva', 'Initials': 'RS', 'LastName': 'Fraga', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil, Post-graduate Program in Dentistry School of Dentistry, Fluminense Federal University, Niterói, RJ, Brazil.'}, {'ForeName': 'Lívia Azeredo Alves', 'Initials': 'LAA', 'LastName': 'Antunes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil; Post-graduate Program in Dentistry School of Dentistry, Fluminense Federal University, Niterói, RJ, Brazil.'}, {'ForeName': 'Walter Luis Soares', 'Initials': 'WLS', 'LastName': 'Fialho', 'Affiliation': 'Professor, School of Medicine, Petropolis University, Petrópolis, RJ, Brazil.'}, {'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Valente', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil.'}, {'ForeName': 'Cinthya Cristina', 'Initials': 'CC', 'LastName': 'Gomes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil.'}, {'ForeName': 'Karla Bianca Fernandes Costa', 'Initials': 'KBFC', 'LastName': 'Fontes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil.'}, {'ForeName': 'Leonardo Santos', 'Initials': 'LS', 'LastName': 'Antunes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil; Post-graduate Program in Dentistry School of Dentistry, Fluminense Federal University, Niterói, RJ, Brazil. Electronic address: leonardoantunes@id.uff.br.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.08.002']
1924,32896753,Proprioceptive neuromuscular facilitation in the functionality and lymphatic circulation of the upper limb of women undergoing breast cancer treatment.,"BACKGROUND


With the increase in survival of women treated for breast cancer, it is necessary to evaluate the effect of therapeutic resources on co-morbidities resulting from the surgical treatment of the disease. The aim of this study was to evaluate the effects of proprioceptive neuromuscular facilitation on the functionality and lymphatic circulation of the upper limb involved in the treatment of breast cancer.
METHODS


The study was conducted according to randomized clinical trial design. Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment, divided into two groups, control - women submitted to standard breast cancer treatment, and treated group, composed of women who underwent breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique. Palmar grip strength with dynamometer and shoulder range of motion with goniometer were evaluated. Lymphatic circulation analysis was performed in a computerized scintillation chamber, before and after therapeutic intervention.
FINDINGS


In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
INTERPRETATION


The results obtained in this study allow us to conclude that proprioceptive neuromuscular facilitation favors an increase in muscle strength, range of motion, but not in lymphatic flow, in women undergoing surgical treatment for breast cancer.",2020,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","['women undergoing surgical treatment for breast cancer', 'women undergoing breast cancer treatment', 'Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment']","['proprioceptive neuromuscular facilitation', 'Proprioceptive neuromuscular facilitation', 'breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique', 'control - women submitted to standard breast cancer treatment']","['muscle strength, range of motion', 'palmar grip strength', 'internal rotation', 'lymphatic flow', 'range of motion of flexion', 'Palmar grip strength with dynamometer and shoulder range of motion with goniometer', 'external rotation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0454481', 'cui_str': 'Proprioceptive neuromuscular facilitation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0575813', 'cui_str': 'Palmar grip'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}]",32.0,0.0146829,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","[{'ForeName': 'Daniela Santana Polati', 'Initials': 'DSP', 'LastName': 'da Silveira', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil. Electronic address: daniela.silveira@unifran.edu.br.'}, {'ForeName': 'Marcelo José', 'Initials': 'MJ', 'LastName': 'Dos Santos', 'Affiliation': 'Departament of Nuclear Medicine, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Eduardo Tinóis', 'Initials': 'ET', 'LastName': 'da Silva', 'Affiliation': 'Departament of Physics in Nuclear Medicine, Radiation Safety and Technology Institute, Campinas, SP, Brazil.'}, {'ForeName': 'Almir José', 'Initials': 'AJ', 'LastName': 'Sarri', 'Affiliation': 'Departament of Physiotherapy, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Lais Mara Siqueira', 'Initials': 'LMS', 'LastName': 'das Neves', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Elaine Caldeira de Oliveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil; Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105158']
1925,32896775,Association of C-reactive protein and metabolic risk with cognitive effects of lurasidone in patients with schizophrenia.,"BACKGROUND


Accumulating evidence has implicated insulin resistance and inflammation in the pathophysiology of cognitive impairments associated with neuropsychiatric disorders. This post-hoc analysis based on a placebo-controlled trial investigated the effect of inflammation (indexed by CRP) and metabolic risk factors on cognitive performance in patients with schizophrenia treated with lurasidone.
METHODS


Acutely exacerbated patients with schizophrenia were randomized to lurasidone (80 or 160 mg/day), quetiapine XR 600 mg/day, or placebo. A wide range CRP test and a cognitive assessment using the CogState computerized battery were performed at baseline and week 6 study endpoint. Associations between log-transformed CRP, high density lipoprotein (HDL), homeostatic model assessment of insulin resistance (HOMA-IR) and treatment response were evaluated.
RESULTS


CRP combined with HDL, triglyceride-to-HDL (TG/HDL) ratio, or HOMA-IR at study baseline were significant moderators of the improvement in cognitive performance associated with lurasidone 160 mg/day (vs. placebo) treatment (p < .05). Greater placebo-corrected treatment effect size on the CogState composite score was observed for patients in the lurasidone 160 mg/day treatment group who had either low CRP and high HDL (d = 0.43), or low CRP and low HOMA-IR (d = 0.46). Interactive relationships between CRP, HDL, TG/HDL, HOMA-IR and the antipsychotic efficacy of lurasidone or quetiapine XR were not significant. There were no significant associations between antipsychotic treatment and changes in CRP level at study endpoint.
CONCLUSIONS


Findings of this post-hoc analysis based on a placebo-controlled trial in patients with schizophrenia suggest that baseline CRP level combined with measures of metabolic risk significantly moderated the improvement in cognitive performance associated with lurasidone 160 mg/day (vs. placebo) treatment. Our findings underscore the importance of maintaining a low metabolic risk profile in patients with schizophrenia.",2020,"Greater placebo-corrected treatment effect size on the CogState composite score was observed for patients in the lurasidone 160 mg/day treatment group who had either low CRP and high HDL (d = 0.43), or low CRP and low HOMA-IR (d = 0.46).","['patients with schizophrenia', 'patients with schizophrenia treated with lurasidone', 'Acutely exacerbated patients with schizophrenia']","['lurasidone', 'placebo', 'quetiapine XR 600\xa0mg/day, or placebo']","['cognitive performance', 'CogState composite score', 'Interactive relationships between CRP, HDL, TG/HDL, HOMA-IR and the antipsychotic efficacy of lurasidone or quetiapine XR', 'CRP combined with HDL, triglyceride-to-HDL (TG/HDL) ratio, or HOMA-IR', 'log-transformed CRP, high density lipoprotein (HDL), homeostatic model assessment of insulin resistance (HOMA-IR) and treatment response', 'CRP level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0994819,"Greater placebo-corrected treatment effect size on the CogState composite score was observed for patients in the lurasidone 160 mg/day treatment group who had either low CRP and high HDL (d = 0.43), or low CRP and low HOMA-IR (d = 0.46).","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry and Health Behavior, Augusta University, Augusta, GA, United States of America. Electronic address: brmiller@augusta.edu.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Pikalov', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ, United States of America.'}, {'ForeName': 'Cynthia O', 'Initials': 'CO', 'LastName': 'Siu', 'Affiliation': 'COS and Associates Ltd., Central, Hong Kong.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tocco', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ, United States of America.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ, United States of America.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Harvey', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, United States of America.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': 'Thriving Mind South Florida, Miami, FL, United States of America; Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ, United States of America.'}]",Comprehensive psychiatry,['10.1016/j.comppsych.2020.152195']
1926,32896776,The long-term influence of hospital and surgeon volume on local control and survival in the randomized German Rectal Cancer Trial CAO/ARO/AIO-94.,"BACKGROUND


The association of treatment volume and oncological outcome of rectal cancer patients undergoing multidisciplinary treatment is subject of an ongoing debate. Prospective data on long-term local control and overall survival (OS) are not available so far. This study investigated the long-term influence of hospital and surgeon volume on local recurrence (LR) and OS in patients with locally advanced rectal cancers.
METHODS


In a post-hoc analysis of the randomized phase III CAO/ARO/AIO-94 trial after a follow-up of more than 10 years, 799 patients with stage II/III rectal cancers were evaluated. LR-rates and OS were stratified by hospital recruitment volume (≤20 vs. 21-90 vs. >90 patients) and by surgeon volume (≤10 vs. 11-50 vs. >50 procedures).
RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03). The surgeon volume was adversely associated with LR (p = 0.01) but had no influence on overall survival. The positive effect of neoadjuvant chemoradiation (CRT) on local control was the strongest in patients being operated by medium-volume surgeons, less in patients being operated by high-volume surgeons and missing in those being operated by low-volume surgeons.
CONCLUSIONS


Patients with locally advanced rectal cancers might benefit from treatment in specialized high-volume hospitals. In particular, the surgeon volume had significant influence on long-term local tumour control. The effect of neoadjuvant CRT on local tumour control may likewise depend on the surgeon volume.",2020,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","['799 patients with stage II/III rectal cancers', 'Patients with locally advanced rectal cancers', 'patients with locally advanced rectal cancers', 'rectal cancer patients undergoing']","['neoadjuvant CRT', 'multidisciplinary treatment', 'neoadjuvant chemoradiation (CRT']","['overall survival (OS', 'LR-rates and OS', 'longer OS', 'long-term local tumour control', 'local control and survival', 'overall survival', 'local recurrence (LR) and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",799.0,0.0971685,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","[{'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany. Electronic address: thilo.sprenger@chiru.med.uni-giessen.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Beißbarth', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sauer', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Tschmelitsch', 'Affiliation': 'Department of Surgery, Krankenhaus der Barmherzigen Brüder, St. Veit an der Glan, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Staib', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Hans-Rudolf', 'Initials': 'HR', 'LastName': 'Raab', 'Affiliation': 'University Department of General and Visceral Surgery, Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University Medical Center Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.021']
1927,32911433,Rationale and methods of the Advanced R 2 Eperfusion STrategies for Refractory Cardiac Arrest (ARREST) trial.,"BACKGROUND


Venoarterial extracorporeal membrane oxygenation has emerged as a prominent therapy for patients with refractory cardiac arrest. However, the optimal time of initiation remains unknown.
AIM


The aim was to assess the rate of survival to hospital discharge in adult patients with refractory ventricular fibrillation/pulseless ventricular tachycardia out-of-hospital cardiac arrest treated with 1 of 2 local standards of care: (1) early venoarterial extracorporeal membrane oxygenation-facilitated resuscitation for circulatory support and percutaneous coronary intervention, when needed, or (2) standard advanced cardiac life support resuscitation.
DESIGN


Phase II, single-center, partially blinded, prospective, intention-to-treat, safety and efficacy clinical trial.
POPULATION


Adults (aged 18-75), initial out-of-hospital cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia, no ROSC following 3 shocks, body morphology to accommodate a Lund University Cardiac Arrest System automated cardiopulmonary resuscitation device, and transfer time of <30 minutes.
SETTING


Hospital-based.
OUTCOMES


Primary: survival to hospital discharge. Secondary: safety, survival, and functional assessment at hospital discharge and 3 and 6 months, and cost.
SAMPLE SIZE


Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients.
CONCLUSIONS


The ARREST trial will generate safety/effectiveness data and comparative costs associated with extracorporeal cardiopulmonary resuscitation, informing broader implementation and a definitive Phase III clinical trial.",2020,"SAMPLE SIZE


Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients.
","['Adults (aged 18-75), initial out-of-hospital cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia, no ROSC following 3 shocks, body morphology to accommodate a Lund University Cardiac Arrest System automated cardiopulmonary resuscitation device, and transfer time of <30\u202fminutes', 'adult patients with refractory ventricular fibrillation/pulseless ventricular tachycardia out-of-hospital cardiac arrest treated with 1 of 2 local standards of care: (1) early', 'patients with refractory cardiac arrest', 'Hospital-based']","['venoarterial extracorporeal membrane oxygenation-facilitated resuscitation for circulatory support and percutaneous coronary intervention', 'extracorporeal cardiopulmonary resuscitation']","['rate of survival to hospital discharge', 'survival to hospital discharge', 'success rates', 'safety, survival, and functional assessment at hospital discharge and 3 and 6\u202fmonths, and cost']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0750196', 'cui_str': 'Pulseless ventricular tachycardia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0183001', 'cui_str': 'Cardiopulmonary resuscitator'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C5192097', 'cui_str': 'Venoarterial extracorporeal membrane oxygenation'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",174.0,0.0924829,"SAMPLE SIZE


Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients.
","[{'ForeName': 'Demetris', 'Initials': 'D', 'LastName': 'Yannopoulos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN. Electronic address: yanno001@umn.edu.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Kalra', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Kosmopoulos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Walser', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Bartos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Murray', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI.'}]",American heart journal,['10.1016/j.ahj.2020.07.006']
1928,32885541,"Efficacy and tolerability of a cream containing modified glutathione (GSH-C4), beta-Glycyrrhetic, and azelaic acids in mild-to-moderate rosacea: A pilot, assessor-blinded, VISIA and ANTERA 3-D analysis, two-center study (The ""Rosazel"" Trial).","BACKGROUND


Rosacea is a very common, chronic inflammatory disease characterized by flushing, erythema and inflammatory lesions. Increased oxidative stress plays a relevant pathogenetic role in Rosacea. Intracellular Glutathione (GSH) is the main scavenger protective mechanism against increased oxidative stress. An altered GSH metabolism in Rosacea has been described. GSH-C4 is a modified GSH molecule characterized by a better intracellular bioavailability and longer half-life. A daily cream (E-AR) containing GSH-C4 (0.1%) with beta-Glycyrrhetic (0.5%) and azelaic acids (10%), with an SPF of 30, is available.
AIM


In a pilot, prospective, two-center, assessor-blinded study we evaluate the efficacy and the tolerability of E-AR cream in subjects with mild to moderate Rosacea treated for 8 weeks.
PATIENTS AND METHODS


The main outcomes were the Investigator Global Assessment (IGA) 7-point score (from 0, completely clear; to 6, severe) and the clinical and instrumental erythema severity score (ESS) (from 0 to 4) evaluated in a blinded fashion (randomly coded photographs) at baseline, after 4 (only clinical) and 8 weeks (clinical and instrumental). VISIA evaluation for erythema and lesion counts and ANTERA 3D analysis for skin haemoglobin concentration (a parameter associated with inflammation) were also performed at the same time points. Analysis of primary outcomes was performed on an intention-to-treat basis. Tolerability was evaluated at week 4 and 8 recording spontaneously reported side effects.
RESULTS


Thirty subjects (22 women and 8 men; mean age 38 years) were enrolled after their written informed consent. Twenty-six (87%) subjects completed the study phases. Four subjects stopped prematurely the trial due to low skin tolerability (n=3) or lost to follow-up (n=1). At baseline, mean (SD) IGA score was 2.6 (0.9). At week 4, IGA score decreased (NS) to 2.3 (1.2). IGA score decreased significantly (p=0.0001) at week 8 to 1.2 (1) (mean difference 1.3; 95% CI of the difference from 0.9 to 1.7) in comparison with the baseline. The inflammatory mean (SD) lesion count, evaluated clinically, were 5.1(2.5) at baseline, 2.8 (1.9) at week 4, and 1.9 (1.7) at week 8 (P=0.0001; ANOVA Test), representing a 63% reduction. This reduction was confirmed by inflammatory lesions count performed on VISIA pictures (from 4.5 at baseline to 1.7 lesions at week 8). Similar evolution was observed for the clinical and instrumental ESS with a reduction of 56% (clinical) and 48% (VISIA), respectively, at week 8 in comparison with the baseline. ANTERA 3D photographs confirmed the positive evolution observed clinically with a significant reduction (-24%) in hemoglobin content: from 1.88 at baseline to 1.44 at week 8.
CONCLUSION


This new GSH-C4, beta-glycyrrethic and azelaic acids cream has shown to be efficacious in mild to moderate rosacea subjects. Local tolerability is in line with other anti-rosacea treatments.",2020,Four subjects stopped prematurely the trial due to low skin tolerability (n=3) or lost to follow-up (n=1).,"['subjects with mild to moderate Rosacea treated for 8 weeks', 'mild to moderate rosacea subjects', 'Twenty-six (87%) subjects completed the study phases', 'mild-to-moderate rosacea', 'Thirty subjects (22 women and 8 men; mean age 38 years', 'Four subjects stopped prematurely the trial due to low skin tolerability (n=3) or lost to follow-up (n=1']","['daily cream (E-AR) containing GSH-C4 (0.1%) with beta-Glycyrrhetic (0.5%) and azelaic acids', 'cream containing modified glutathione (GSH-C4), beta-Glycyrrhetic and azelaic acids', 'E-AR cream', 'Intracellular Glutathione (GSH']","['mean (SD) IGA score', 'Efficacy and tolerability', 'hemoglobin content', 'intention-to-treat basis', 'Investigator Global Assessment (IGA) 7-point score (from 0, completely clear; to 6, severe) and the clinical and instrumental erythema severity score (ESS', 'Local tolerability', 'inflammatory mean (SD) lesion count', 'VISIA evaluation for erythema and lesion counts and ANTERA 3D analysis for skin haemoglobin concentration', 'Tolerability', 'IGA score']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3254242', 'cui_str': 'glutathione-C4'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0052761', 'cui_str': 'azelaic acid'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}]",22.0,0.169364,Four subjects stopped prematurely the trial due to low skin tolerability (n=3) or lost to follow-up (n=1).,"[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': ""Dall'Oglio"", 'Affiliation': 'Dermatology Clinic, University of Catania, Catania, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Puviani', 'Affiliation': 'Dermatology Service Medica Plus Modena, Modena, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Milani', 'Affiliation': 'Cantabria Labs Difa Cooper Medical Department, Catania, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Micali', 'Affiliation': 'Dermatology Clinic, University of Catania, Catania, Italy.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13707']
1929,32888384,Adipose tissue stromal vascular fraction and adipose tissue stromal vascular fraction plus platelet-rich plasma grafting: New regenerative perspectives in genital lichen sclerosus.,"Lichen sclerosus (LS) is a chronic relapsing, inflammatory skin disorder usually involving the anogenital region of both sexes lacking a resolutive therapy. This study compared adipose tissue derived-stromal vascular fraction (AD-SVF) and AD-SVF-enriched platelet-rich plasma (PRP) therapy in the management of genital LS patients. Additionally, in vitro evaluation of cells and growth factors contained in the injected SVF has been evaluated as possible predictive factors for treatment outcome. The study population was 40 patients diagnosed with LS who were symptomatic despite medical treatment. Patients (age 43-78 years) randomized into two groups using a 1:1 allocation ratio, were evaluated clinically and assessing dermatology life quality index (DLQI) before and 6 months after treatment. Both procedures demonstrated a strong safety profile with no complications linked to the therapy. After 6 months, both treatments allowed for a significant improvement respect to baseline. Combinatory therapy demonstrated decreased efficacy in late stage patients. No correlations have been found between clinical and biological findings. AD-SVF and AD-SVF plus PRP are safe and effective regenerative approaches for genital LS patients. Clinical results support the preferential use of combinatory therapy for early stage patients confirming a synergic effect of AD-SVF and PRP. In contrast, AD-SVF plus PRP is discouraged for late stage patients.",2020,"After 6 months, both treatments allowed for a significant improvement respect to baseline.","['Patients (age 43-78\u2009years', 'late stage patients', 'early stage patients', '40 patients diagnosed with LS who were symptomatic despite medical treatment', 'genital LS patients']","['AD-SVF and AD-SVF plus PRP', 'Combinatory therapy', 'AD-SVF plus PRP', 'Lichen sclerosus (LS', 'adipose tissue derived-stromal vascular fraction (AD-SVF) and AD-SVF-enriched platelet-rich plasma (PRP) therapy']","['efficacy', 'Dermatology Life Quality Index (DLQI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023652', 'cui_str': 'Lichen sclerosus et atrophicus'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0406641', 'cui_str': 'Genital lichen sclerosus'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023652', 'cui_str': 'Lichen sclerosus et atrophicus'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}]",,0.0363478,"After 6 months, both treatments allowed for a significant improvement respect to baseline.","[{'ForeName': 'Marinella', 'Initials': 'M', 'LastName': 'Tedesco', 'Affiliation': 'Department of Plastic and Regenerative Surgery, San Gallicano Dermatological Institute IRCCS, Rome, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Bellei', 'Affiliation': 'Laboratory of Cutaneous Physiopathology and Integrated Center of Metabolomics Research, San Gallicano Dermatological Institute, IRCCS, Rome, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Garelli', 'Affiliation': 'Department of Plastic and Regenerative Surgery, San Gallicano Dermatological Institute IRCCS, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Caputo', 'Affiliation': 'Laboratory of Cutaneous Physiopathology and Integrated Center of Metabolomics Research, San Gallicano Dermatological Institute, IRCCS, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Latini', 'Affiliation': 'Lichen Sclerosus Unit, Department of Dermatology STI, Environmental Health, Tropical and Immigration, San Gallicano Dermatological Institute, IRCCS, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Giuliani', 'Affiliation': 'Lichen Sclerosus Unit, Department of Dermatology STI, Environmental Health, Tropical and Immigration, San Gallicano Dermatological Institute, IRCCS, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cota', 'Affiliation': 'Department of Dermatology, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Chichierchia', 'Affiliation': 'Immunohaematology and Trasfusion Medicine, IRCCS Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Romani', 'Affiliation': 'Department of Plastic and Regenerative Surgery, San Gallicano Dermatological Institute IRCCS, Rome, Italy.'}, {'ForeName': 'Maria Laura', 'Initials': 'ML', 'LastName': 'Foddai', 'Affiliation': 'Immunohaematology and Trasfusion Medicine, IRCCS Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cristaudo', 'Affiliation': 'Lichen Sclerosus Unit, Department of Dermatology STI, Environmental Health, Tropical and Immigration, San Gallicano Dermatological Institute, IRCCS, Rome, Italy.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Morrone', 'Affiliation': 'Scientific Director San Gallicano Dermatological Institute, IRCCS, Rome, Italy.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Migliano', 'Affiliation': 'Department of Plastic and Regenerative Surgery, San Gallicano Dermatological Institute IRCCS, Rome, Italy.'}]",Dermatologic therapy,['10.1111/dth.14277']
1930,32888452,"Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND


Venetoclax plus obinutuzumab has been established as a fixed-duration treatment regimen for patients with chronic lymphocytic leukaemia. We compared the long-term efficacy after treatment cessation of the combination of venetoclax plus obinutuzumab with chlorambucil plus obinutuzumab in patients with previously untreated chronic lymphocytic leukaemia.
METHODS


CLL14 is a multicentre, randomised, open-label, phase 3 trial done at 196 sites in 21 countries. Eligible patients were aged 18 years or older, had untreated chronic lymphocytic leukaemia, and coexisting conditions with a cumulative illness rating scale greater than 6, a creatinine clearance of 30-69 mL/min, or both. Patients were randomly assigned (1:1) via a web and voicemail system with allocation concealment and based on a computer-generated randomisation schedule with a block size of six and stratified by Binet stage and geographical region. Patients received either venetoclax plus obinutuzumab (oral venetoclax initiated on day 22 of cycle 1 [28-day cycles], with a 5-week dose ramp-up [20 mg, 50 mg, 100 mg, and 200 mg, then 400 mg daily for 1 week], thereafter continuing at 400 mg daily until completion of cycle 12; combined with intravenous obinutuzumab for six cycles starting with 100 mg on day 1 and 900 mg on day 2 [or 1000 mg on day 1], 1000 mg on days 8 and day 15 of cycle 1, and subsequently 1000 mg on day 1 of cycles 2 through 6) or chlorambucil plus obinutuzumab (oral chlorambucil at 0·5 mg/kg bodyweight on days 1 and 15 of each cycle for 12 cycles combined with the same obinutuzumab regimen). The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. Patient enrolment is complete, and the study is registered with ClinicalTrails.gov, NCT02242942.
FINDINGS


Between Aug 7, 2015, and Aug 4, 2016, 432 patients were enrolled and randomly assigned to receive either venetoclax plus obinutuzumab (n=216) or chlorambucil plus obinutuzumab (n=216). All patients had been off treatment for at least 24 months at data collection. At a median follow-up of 39·6 months (IQR 36·8-43·0), patients given venetoclax plus obinutuzumab had a significantly longer progression-free survival than did patients given chlorambucil plus obinutuzumab (HR 0·31, 95% CI 0·22-0·44; p<0·0001). Median progression-free survival was not reached (95% CI not estimable to not estimable) in the venetoclax plus obinutuzumab group vs 35·6 months (33·7-40·7) in the chlorambucil plus obinutuzumab group. The most common grade 3 or 4 adverse event in both groups was neutropenia (112 [53%] of 212 patients in the venetoclax plus obinutuzumab group versus 102 [48%] of 214 patients in the chlorambucil plus obinutuzumab group). Serious adverse events occurred in 115 (54%) of 212 patients in the venetoclax plus obinutuzumab group and 95 (44%) of 214 patients in the chlorambucil plus obinutuzumab group. Venetoclax or chlorambucil treatment-related deaths were reported in one (1%) of 212 patients in the venetoclax plus obinutuzumab group (n=1 sepsis) and two (1%) of 214 patients in the chlorambucil plus obinutuzumab group (n=1 septic shock, n=1 metastatic skin squamous carcinoma).
INTERPRETATION


2 years after treatment cessation, venetoclax plus obinutuzumab continues to significantly improve progression-survival compared with chlorambucil plus obinutuzumab, thereby providing a limited duration treatment option for patients with previously untreated chronic lymphocytic leukaemia.
FUNDING


F Hoffmann-La Roche and AbbVie.",2020,Median progression-free survival was not reached (95% CI not estimable to not estimable) in the venetoclax plus obinutuzumab group vs 35·6 months (33·7-40·7) in the chlorambucil plus obinutuzumab group.,"['previously untreated chronic lymphocytic leukaemia (CLL14', 'patients with previously untreated chronic lymphocytic leukaemia', 'Eligible patients were aged 18 years or older, had untreated chronic lymphocytic leukaemia, and coexisting conditions with a cumulative illness rating scale greater than 6, a creatinine clearance of 30-69 mL/min, or both', 'patients with chronic lymphocytic leukaemia', '196 sites in 21 countries', 'Between Aug 7, 2015, and Aug 4, 2016, 432 patients', '212 patients in the venetoclax plus obinutuzumab group (n=1 sepsis) and two (1%) of 214 patients in the chlorambucil plus obinutuzumab group (n=1 septic shock, n=1 metastatic skin squamous carcinoma']","['venetoclax plus obinutuzumab with chlorambucil plus obinutuzumab', 'venetoclax plus obinutuzumab (oral venetoclax', 'Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab', 'chlorambucil plus obinutuzumab', 'intravenous obinutuzumab', 'Venetoclax or chlorambucil', 'venetoclax plus obinutuzumab', 'chlorambucil plus obinutuzumab (oral chlorambucil', 'voicemail system with allocation concealment and based on a computer-generated randomisation schedule with a block size of six and stratified by Binet stage and geographical region']","['Safety', 'longer progression-free survival', 'Serious adverse events', 'investigator-assessed progression-free survival', 'neutropenia', 'progression-survival', 'Median progression-free survival']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",432.0,0.282151,Median progression-free survival was not reached (95% CI not estimable to not estimable) in the venetoclax plus obinutuzumab group vs 35·6 months (33·7-40·7) in the chlorambucil plus obinutuzumab group.,"[{'ForeName': 'Othman', 'Initials': 'O', 'LastName': 'Al-Sawaf', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Maneesh', 'Initials': 'M', 'LastName': 'Tandon', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Samoylova', 'Affiliation': 'Regional Clinical Hospital NA Semashko, Nizhny Novgorod, Russia.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Division of Onco-Hematology, Santa Maria Terni Hospital, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pinilla-Ibarz', 'Affiliation': 'Department of Malignant Hematology, H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Opat', 'Affiliation': 'Haematology Department, School of Clinical Sciences at Monash Health, Monash University, VIC, Australia.'}, {'ForeName': 'Liliya', 'Initials': 'L', 'LastName': 'Sivcheva', 'Affiliation': 'First Internal Department, MHAT Hristo Botev, AD, Vratsa, Bulgaria.'}, {'ForeName': 'Katell', 'Initials': 'K', 'LastName': 'Le Dû', 'Affiliation': 'Hematology Department, Clinique Le Mans, France.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Fogliatto', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carsten U', 'Initials': 'CU', 'LastName': 'Niemann', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weinkove', 'Affiliation': 'Wellington Blood and Cancer Centre, Capital and Coast District Health Board and Malaghan Institute of Medical Research, Wellington, New Zealand.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Queen Elizabeth II Health Science Center, Halifax, NS, Canada.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'Moores Cancer Center, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department III of Internal Medicine, Ulm University, Ulm, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Schary', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Ritgen', 'Affiliation': 'Department II of Internal Medicine, Campus Kiel, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Clemens-Martin', 'Initials': 'CM', 'LastName': 'Wendtner', 'Affiliation': 'Department of Hematology, Oncology, Immunology, Palliative Care, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Karl-Anton', 'Initials': 'KA', 'LastName': 'Kreuzer', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department III of Internal Medicine, Ulm University, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany. Electronic address: michael.hallek@uk-koeln.de.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30443-5']
1931,32889329,Improving reproductive outcomes of intrauterine insemination: Does endometrial scratch injury help? A randomised controlled trial.,"OBJECTIVE(S)


Current evidence suggests that endometrial injury improves clinical pregnancy rate while having no effect on miscarriages in women undergoing IVF/ICSI. However, there is no substantial evidence to advocate the use of endometrial injury to benefit the outcomes of IUI treatment. Additionally, there is no clear consensus about the ideal timing, underlying mechanism and optimum intensity of endometrial injury required. The study examines the effect of intentional endometrial injury/scratch in the early proliferative phase of stimulated cycle on reproductive outcomes (clinical and ongoing pregnancy rates and miscarriage occurrence) of intra-uterine insemination treatment (IUI).
STUDY DESIGN, SIZE, DURATION


This prospective, randomized control interventional study was conducted in a tertiary level teaching institution from April 2018 to February 2020. 150 eligible couples requiring IUI treatment who agreed to participate were randomly allocated on 1:1 basis to either control or intervention group. The trial participants received up to 3 cycles ovulation induction with clomiphene citrate and intra-uterine insemination. In addition, women in intervention group were subjected to endometrial scratch injury on day 6-7 of their stimulated cycle. 154 cycles in control arm and 128 cycles in intervention group were analyzed for clinical pregnancy, miscarriages and pain experienced by the women during endometrial scratch injury using the statistical package SPSS (version 21).
RESULT


Similar cumulative clinical pregnancy rates (12.5% Vs 13.6%, RR 1.21, 95% CI 0.44-3.37, p = 0.713), biochemical pregnancy rates (17.1% vs 22.9%, RR 1.43, CI 0.59-3.47, p = 0.421) and ongoing pregnancy rates (10.93% Vs 11.47%, RR 1.05, CI 0.35-3.21, p = 924) were observed in control and intervention arms. Likewise, the relative risk of miscarriage occurrence in the intervention arm was 1.32 (95% CI 0.39-4.32, p = 1.000) which was not statistically different from control group. Mean pain score of 6.93 on numerical pain rating scale was experienced by women whilst having endometrial scratch injury.
CONCLUSIONS


There is insufficient evidence to defend the use of endometrial scratch injury in intra-uterine insemination treatment, as it is moderately painful and have uncertain beneficial influence on reproductive outcomes.",2020,"Vs 13.6%, RR 1.21, 95% CI 0.44-3.37, p = 0.713), biochemical pregnancy rates (17.1% vs 22.9%, RR 1.43, CI 0.59-3.47, p = 0.421) and ongoing pregnancy rates (10.93% Vs 11.47%, RR 1.05, CI 0.35-3.21, p = 924) were observed in control and intervention arms.","['tertiary level teaching institution from April 2018 to February 2020', '150 eligible couples requiring IUI treatment who agreed to participate']","['intrauterine insemination', 'intentional endometrial injury/scratch', 'intra-uterine insemination treatment (IUI', 'clomiphene citrate and intra-uterine insemination']","['reproductive outcomes (clinical and ongoing pregnancy rates and miscarriage occurrence', 'clinical pregnancy rate', 'Mean pain score', 'cumulative clinical pregnancy rates', 'ongoing pregnancy rates', 'numerical pain rating scale', 'biochemical pregnancy rates', 'relative risk of miscarriage occurrence']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}]","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",150.0,0.317085,"Vs 13.6%, RR 1.21, 95% CI 0.44-3.37, p = 0.713), biochemical pregnancy rates (17.1% vs 22.9%, RR 1.43, CI 0.59-3.47, p = 0.421) and ongoing pregnancy rates (10.93% Vs 11.47%, RR 1.05, CI 0.35-3.21, p = 924) were observed in control and intervention arms.","[{'ForeName': 'Navdeep Kaur', 'Initials': 'NK', 'LastName': 'Ghuman', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Jodhpur, 342005, India. Electronic address: drnavdeepghuman@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Raikar', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Jodhpur, 342005, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Jodhpur, 342005, India. Electronic address: drpratibha69@hotmail.com.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Gothwal', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Jodhpur, 342005, India.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Yadav', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Jodhpur, 342005, India.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.08.010']
1932,32889373,Benefit-harm balance of fingolimod in patients with MS: A modelling study based on FREEDOMS.,"BACKGROUND


Fingolimod lowers the number of relapses in multiple sclerosis (MS) patients and slows down disease progression, but causes a broad spectrum of side effects. Our aim was to estimate the benefit-harm balance of fingolimod using individual patient data from FREEDOMS, a randomized controlled trial that compared two different dosages of fingolimod to placebo.
METHODS


We modelled the health status of patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health). The model considered Expanded Disability Status Scale measurements, relapses and adverse events. We compared the mean health status between arms, and the proportion of trial participants for whom health declined or improved compared to baseline by a predefined minimal important difference of 4.6 or more.
RESULTS


The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2). Patients on fingolimod 0.5mg were 0.53 (95% CI 0.40-0.72, p<0.001) times less likely to have a relevant decline in health status compared to patients on placebo, corresponding to a number needed to treat of 8 to prevent one relevant decline in health status. All sensitivity analyses favoured fingolimod 0.5mg.
CONCLUSION


Although fingolimod's net benefit did not reach the clinical relevance on average, the decreased risk for a decline in health over two years may be relevant. This approach could be applied to other MS drugs and provide an objective evidence base for guideline recommendations.",2020,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","['patients with MS', 'patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health']","['placebo', 'fingolimod to placebo']","['mean health status', 'Disability Status Scale measurements, relapses and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0681887', 'cui_str': 'Measurement scales'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.143984,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Spanu', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Hélène E', 'Initials': 'HE', 'LastName': 'Aschmann', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Kesselring', 'Affiliation': 'RehaKliniken Valens, Zurich, Switzerland.'}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland. Electronic address: miloalan.puhan@uzh.ch.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102464']
1933,32889413,Outcomes of individualized goal-directed therapy based on cerebral oxygen balance in high-risk patients undergoing cardiac surgery: A randomized controlled trial.,"STUDY OBJECTIVE


To investigate whether optimizing individualized goal-directed therapy (GDT) based on cerebral oxygen balance in high-risk surgical patients would reduce postoperative morbidity.
DESIGN


This was a prospective, randomized, controlled study.
SETTING


The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018.
PATIENTS


146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled.
INTERVENTION


Patients were randomized to an individualized GDT group or usual care group. Individualized GDT was targeted to achieve the following goals: A less than 20% decline in the regional cerebral oxygen saturation (rScO 2 ) level from baseline; a less than 20% decline in the mean arterial pressure (MAP) from baseline, as well as a bispectral index (BIS) of 45-60 before and after CPB and 40-45 during CPB.
MEASUREMENTS


The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications.
MAIN RESULTS


128 completed the trial and were included in the modified intention-to-treat analysis. Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15). Secondary analysis showed that 75 (59%) of 128 patients achieved individual targets (irrespective of intervention) and sustained less morbidity (relative risk 3.41, 95% CI 2.19-5.31; P < 0.001).
CONCLUSIONS


In high-risk patients undergoing cardiac surgery, individualized GDT therapy did not yield better outcomes, however, the achievement of preoperative individual targets may be associated with less morbidity.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03103633. Registered on 1 April 2017.",2020,"Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15).","['high-risk surgical patients', 'high-risk patients undergoing cardiac surgery', 'The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018', '146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled']","['individualized goal-directed therapy', 'cardiac surgery, individualized GDT therapy', 'individualized goal-directed therapy (GDT', 'individualized GDT group or usual care group']","['mean arterial pressure (MAP', 'Early morbidity', 'morbidity', 'cerebral oxygen balance', 'regional cerebral oxygen saturation (rScO 2 ) level', 'bispectral index (BIS', 'composite endpoint of 30-day mortality and major postoperative complications']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",,0.315518,"Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15).","[{'ForeName': 'Xin-Qi', 'Initials': 'XQ', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_mz_cheng@126.com.'}, {'ForeName': 'Jun-Yan', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacology, Anhui Medical University, 230032 Hefei, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'You-Mei', 'Initials': 'YM', 'LastName': 'Zuo', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Er-Wei', 'Initials': 'EW', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_guew_mz@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110032']
1934,32889425,Effectiveness of a social problem solving training in youth in detention or on probation: An RCT and pre-post community implementation.,"The effectiveness of a 10-session social problem-solving training (SPST) was evaluated in two independent studies in a juvenile justice (JJ) setting. In both studies, we aimed to examine main intervention effects on social problem-solving skills and recidivism, as well as differential effects as modulated by anger, anger regulation, and single nucleotide polymorphisms in the COMT gene. In Study 1, a randomized controlled trial (RCT), 289 male detainees (M age = 14.95 years) were randomly assigned to SPST or treatment-as-usual (TAU). In Study 2, a pre-post community implementation, 187 youth (M age  = 16.03 years) on probation were assessed before and after SPST. No significant main effects of SPST on social problem solving or recidivism were shown in either study. With regard to differential effects, among youth in detention,COMT haplotypes predicted intervention effects on state anger. Moreover, independent of SPST, inward anger expression was associated with an increase in state anger from pre- to post and an increase in state anger with a decrease in social problem solving. Among youth on probation, COMT haplotypes predicted social problem-solving skills, and, in turn, an increase in social problem-solving skills decreased the odds of recidivism after SPST. The lack of main effects of SPST may be due to low program integrity in JJ settings. Juveniles' emotional and genetic characteristics might modulate the effectiveness of interventions in JJ settings. We recommend studying large samples to substantiate this observation.",2020,No significant main effects of SPST on social problem solving or recidivism were shown in either study.,"['289 male detainees (M age =\xa014.95\xa0years', '187 youth (M age \xa0=\xa016.03\xa0years) on probation were assessed before and after SPST', 'youth in detention or on probation']","['social problem solving training', 'SPST or treatment-as-usual (TAU', '10-session social problem-solving training (SPST', 'SPST']","['social problem solving', 'social problem solving or recidivism', 'social problem-solving skills', 'state anger']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0425169', 'cui_str': 'On probation'}, {'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0037431', 'cui_str': 'Social problem'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",289.0,0.0357068,No significant main effects of SPST on social problem solving or recidivism were shown in either study.,"[{'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Hein', 'Affiliation': 'Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Weeland', 'Affiliation': 'Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Square', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Haeffel', 'Affiliation': 'University of Notre Dame, Notre Dame, IN, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chapman', 'Affiliation': 'Connecticut Judicial Branch, Court Support Services Division, Wethersfield, CT, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Macomber', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Foley Geib', 'Affiliation': 'Connecticut Judicial Branch, Court Support Services Division, Wethersfield, CT, USA.'}, {'ForeName': 'Elena L', 'Initials': 'EL', 'LastName': 'Grigorenko', 'Affiliation': 'Yale University, New Haven, CT, USA; University of Houston, Houston, TX, USA; Baylor College of Medicine, Houston, TX, USA. Electronic address: Elena.Grigorenko@times.uh.edu.'}]",International journal of law and psychiatry,['10.1016/j.ijlp.2020.101626']
1935,32890813,CONKO-006: A randomised double-blinded phase IIb-study of additive therapy with gemcitabine + sorafenib/placebo in patients with R1 resection of pancreatic cancer - Final results.,"BACKGROUND


CONKO-006 was designed for patients with pancreatic adenocarcinoma with postsurgical R1 residual status to evaluate the efficacy and safety of the combination of gemcitabine and sorafenib (GemSorafenib) compared with those of gemcitabine + placebo (GemP) for 12 cycles.
PATIENTS AND METHODS


This randomised, double-blind, placebo-controlled, multicenter study was planned to detect an improvement in recurrence-free survival (RFS) from 42% to 60% after 18 months. Secondary objectives were overall survival (OS), safety and duration of treatment.
RESULTS


122 patients were included between 02/2008 and 09/2013; 57 were randomised to GemSorafenib and 65 to GemP. Patient characteristics were wellbalanced (GemSorafenib/GemP) in terms of median age (63/63 years), tumour size (T3/T4: 97/97%), and nodal positivity (86/85%). Grade 3/4 toxicities comprised diarrhoea (GemSorafenib: 12%; GemP: 2%), elevated gamma-glutamyl transferase (GGT) (19%; 9%), fatigue (5%; 2%) and hypertension (5%; 2%), as well as neutropenia (18%; 25%) and thrombocytopenia (9%; 2%). By August 2017, 118 (97%) RFS event had occurred. There were no difference in RFS (median GemSorafenib: 8.5 versus GemP: 9.4 months; p = 0.730) nor OS (median GemSorafenib: 17.6 versus GemP: 17.5 months; p = 0.481). Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021).
CONCLUSION


CONKO-006 is the first randomised clinical trial to include exclusively patients with PDAC with postsurgical R1 status thus far. Sorafenib added to gemcitabine did neither improve RFS nor OS. However, postoperative treatment exceeding six months seemed to prolong survival and should be further investigated in these high-risk patients.
CLINICAL TRIAL INFORMATION


German Tumor Study Registry (Deutsches Krebsstudienregister), DRKS00000242.",2020,"Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021).
","['patients with R1 resection of pancreatic cancer - Final results', '122 patients were included between 02/2008 and 09/2013; 57 were randomised to GemSorafenib and 65 to GemP', 'German Tumor Study Registry', 'patients with pancreatic adenocarcinoma with postsurgical R1 residual status']","['gemcitabine + sorafenib/placebo', 'gemcitabine\xa0+\xa0placebo (GemP', 'gemcitabine and sorafenib (GemSorafenib', 'Sorafenib', 'placebo', 'gemcitabine']","['recurrence-free survival (RFS', 'thrombocytopenia', 'hypertension', 'RFS nor OS', 'survival', 'fatigue', 'RFS (median GemSorafenib', 'neutropenia', 'longer OS', 'nodal positivity', 'overall survival (OS), safety and duration of treatment', 'Grade 3/4 toxicities comprised diarrhoea', 'elevated gamma-glutamyl transferase (GGT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}]",122.0,0.424538,"Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sinn', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany; Universitätsklinikum Hamburg-Eppendorf, Department of Medical Oncology, Hamburg, Germany. Electronic address: ma.sinn@uke.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Liersch', 'Affiliation': 'University of Göttingen, Department of General, Visceral and Pediatric Surgery, Göttingen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gellert', 'Affiliation': 'Sana Klinikum Lichtenberg, Department of General and Visceral Surgery, Berlin, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stübs', 'Affiliation': 'Otto-Guericke-University of Magdeburg, Department of General, Visceral and Vascular Surgery, Magdeburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Waldschmidt', 'Affiliation': 'University of Köln, Department of Gastroenterology and Hepatology, Köln, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lammert', 'Affiliation': 'Universitätskliniken des Saarlandes, Department of Internal Medicine, Gastroenterology and Endocrinology, Homburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Maschmeyer', 'Affiliation': 'Ernst von Bergmann Klinikum, Department of Hematology, Oncology and Palliative Care, Potsdam, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bechstein', 'Affiliation': 'Universitätsklinikum Frankfurt, Department of General and Visceral Surgery, Frankfurt, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bitzer', 'Affiliation': 'Eberhard-Karls-Universität Tübingen, Department of Internal Medicine, Tübingen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denzlinger', 'Affiliation': 'Marienhospital Stuttgart, Department of Hematology, Oncology and Palliative Care, Stuttgart Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hofheinz', 'Affiliation': 'Universitätsklinikum Mannheim, Department of Medical Oncology, Mannheim, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Lindig', 'Affiliation': 'Universitätsklinikum Jena, Department of Hematology and Oncology, Jena, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'University of Göttingen, Department of General, Visceral and Pediatric Surgery, Göttingen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hinke', 'Affiliation': 'CCRC, Düsseldorf, Germany.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Striefler', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bischoff', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bahra', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Surgery, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Oettle', 'Affiliation': 'Outpatient Department of Hematology/Oncology, Friedrichshafen, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.06.032']
1936,32890969,Effect of high-intensity interval training on cardiac structure and function in rats with acute myocardial infarct.,"BACKGROUND


Exercise training is beneficial for cardiac rehabilitation. Nevertheless, few study focused on the role of high-intensity interval training (HIIT) in cardiac repair. The current study aimed to elucidate the effect of HIIT on cardiac rehabilitation and the involved mechanisms after acute myocardial infarction (MI).
METHODS


A total of 65 male rats underwent coronary ligation or sham operation and were randomly assigned to 4 groups: sham (n = 10), sedentary (MI-Sed, n = 12), moderate-intensity continuous training (MI-MCT, n = 12) and HIIT (MI-HIIT, n = 12). One week after MI induction, adaptive training starts follow by formal training. After the experiment, cardiac functions were determined by echocardiography and hemodynamic measurements. Changes in infarct size, collagen accumulation, myofibroblasts, angiogenesis, inflammation level, endothelin-1 (ET-1), and renin-angiotensin-aldosterone system (RAAS) activities were measured. Data were analyzed by one-way ANOVA.
RESULTS


After MI, cardiac structure and function were significantly deteriorated. However, post-MI HIIT for 8 weeks had significantly ameliorated left ventricular end-diastolic pressure (LVEDP), LV systolic pressure (LVSP), and maximum peak velocities of relaxation (-dP/dtmax). Moreover, it preserved cardiac functions, reduced infarct size, protected the myocardium structure, increased angiogenesis and decreased the myofibroblasts and collagen accumulation. HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis. Additionally, it induced inflammation response and repressed ET-1 and RAAS activities were found in myocardium and peripheral circulation after HIIT.
CONCLUSION


Our results suggested that post-MI HIIT had a positive role in cardiac repair, which might be linked with the induction of inflammation and inhibition of ET-1 and RAAS activities.",2020,"HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis.","['65 male rats underwent', 'rats with acute myocardial infarct']","['Exercise training', 'HIIT', 'coronary ligation or sham operation', 'high-intensity interval training', 'moderate-intensity continuous training']","['RAAS) activities', 'cardiac functions', 'inflammation response and repressed ET-1 and RAAS activities', 'cardiac structure and function', 'myofibroblasts and collagen accumulation', 'LVEDP, -dP/dtmax, infarct size and angiogenesis', 'ameliorated left ventricular end-diastolic pressure (LVEDP), LV systolic pressure (LVSP), and maximum peak velocities of relaxation (-dP/dtmax', 'infarct size, collagen accumulation, myofibroblasts, angiogenesis, inflammation level, endothelin-1 (ET-1), and renin-angiotensin-aldosterone system ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0225360', 'cui_str': 'Myofibroblast'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",65.0,0.0338951,"HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis.","[{'ForeName': 'Bozhong', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Rongfang', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Xinwen', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Shou', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Cuicui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Tong', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Genxiang', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Zhejiang Provincial Key Laboratory of Geriatrics & Geriatrics Institute of Zhejiang Province, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Zhejiang Provincial Key Laboratory of Geriatrics & Geriatrics Institute of Zhejiang Province, Hangzhou, 310013, Zhejiang, China. Electronic address: aaiwuqing@126.com.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110690']
1937,32891018,Effects of multimodal balance training supported by rhythmical auditory stimuli in people with advanced stages of Parkinson's disease: a pilot randomized clinical trial.,"Non-pharmacological interventions such as physiotherapy are recognized as important elements in the overall clinical management of motor impairments in PD, but evidence of physiotherapy in advanced disease stages is sparse. A recent trial found positive effects of multimodal balance training in people with mild to moderate PD, with greater and more sustained effects when rhythmical auditory stimuli were added. It is unclear whether such multimodal balance training is also effective in people with advanced PD (Hoehn & Yahr stage 4).
METHODS


We performed a pilot prospective single-blind, randomized clinical trial to study the effectiveness of multimodal training with and without rhythmical auditory stimuli. We screened 76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients were assigned randomly into two groups: (1) multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n = 17) and (2) multimodal balance training without rhythmical auditory cues (n = 18). Training was performed for 5 weeks, two times/week. Primary outcome was the Mini-BESTest (MBEST) score immediately after the training period. Assessments were performed by the same two blinded assessors at baseline, immediately post intervention, and after one and 6-months follow-up.
RESULTS


Immediately post-intervention, both intervention groups improved significantly on Mini-Best scores, without differences between both intervention modalities. In both groups, results were retained at one-month follow-up. At 6-months follow-up, the effects were retained only in the RAS-supported intervention group. For both intervention groups, no improvements were found on secondary outcome measures for gait.
CONCLUSION


Both RAS-supported multimodal balance training and regular multimodal balance training improve balance in PD patients in advanced disease stages. Effects appear to sustain longer in the RAS-supported training group.",2020,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","['PD patients in advanced disease stages', ""people with advanced stages of Parkinson's disease"", 'people with advanced PD (Hoehn & Yahr stage 4', 'people with mild to moderate PD', ""76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients""]","['multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n\xa0=\xa017) and (2) multimodal balance training without rhythmical auditory cues', 'multimodal balance training and regular multimodal balance training', 'multimodal balance training', 'multimodal training with and without rhythmical auditory stimuli']","['Mini-BESTest (MBEST) score', 'gait', 'Mini-Best scores', 'rhythmical auditory stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}]",76.0,0.0570846,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","[{'ForeName': 'Tamine T C', 'Initials': 'TTC', 'LastName': 'Capato', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil. Electronic address: tamine.capato@radboudumc.nl.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour; Department of Rehabilitation, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; Sint Maartenskliniek, Department of Rehabilitation, Nijmegen, the Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Radboud University Medical Center, Department for Health Evidence, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117086']
1938,32892376,Developmental outcome of extremely preterm infants is improved after less invasive surfactant application: Developmental outcome after LISA.,"AIM


The aim of this study was to evaluate neurocognitive outcome at 24 months of corrected age after less invasive surfactant application (LISA) in preterm infants born at 23-26 weeks of gestational age.
METHODS


Surviving participants of a LISA trial conducted in 13 German level III neonatal intensive care units were reviewed for assessment of developmental outcome, hearing and vision problems, growth and rehospitalisation days. Maternal depression, breastfeeding rates and socio-economic factors were evaluated as potentially confounding factors.
RESULTS


In total, 156/182 infants took part in the study, 78 had received surfactant via LISA and 78 via endotracheal intubation. 22% of LISA infants compared to 42% of intubated infants had a psychomotor development index (PDI) <70 (0.012). A significant difference in mental development index (MDI) was observed in the stratum of more mature infants (25 and 26 weeks of GA). For this group, MDI < 70 was observed in 4% of LISA infants vs 21% of intubated infants (P = 0.008).
CONCLUSION


At 24 months of age, the LISA-treated infants scored less often PDI < 70 and had similar results in MDI. Infants born at 25 and 26 weeks treated with LISA had lower rates of severe disability. LISA is safe and may be superior.",2020,At 24 months of age the LISA treated infants scored less often PDI<70 and had similar results in MDI.,"['extremely preterm infants', 'p4reterm infants born at 23 - 26 weeks gestational age', 'Surviving participants of a LISA trial conducted in 13 German level III neonatal intensive care units were reviewed for assessment of developmental outcome, hearing and vision problems, growth and rehospitalization days', '156/182 infants took part in the study, 78 had received']","['surfactant via LISA', 'LISA', 'invasive surfactant application (LISA']","['mental development index (MDI', 'psychomotor development index', 'MDI', 'rates of severe disability', 'neurocognitive outcome', 'Maternal depression, breastfeeding rates and socioeconomic factors']","[{'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392358', 'cui_str': 'Psychomotor development'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]",,0.0626624,At 24 months of age the LISA treated infants scored less often PDI<70 and had similar results in MDI.,"[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mehler', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Broer', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Roll', 'Affiliation': ""Department of Neonatology, Vest Children's Hospital Datteln, University Witten-Herdecke, Witten-Herdecke, Germany.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Göpel', 'Affiliation': 'Department of Pediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wieg', 'Affiliation': 'Department of Neonatology, Klinikum Aschaffenburg, Aschaffenburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jahn', 'Affiliation': ""Department of Neonatology, Children's Hospital Leverkusen, Leverkusen, Germany.""}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Teig', 'Affiliation': ""Department of Neonatology, Children's Hospital, Ruhr-University Bochum, Bochum, Germany.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Höhn', 'Affiliation': 'Department of General Pediatrics, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Welzing', 'Affiliation': 'Department of Neonatology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vochem', 'Affiliation': 'Department of Neonatology, Olga Hospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hoppenz', 'Affiliation': ""Department of Neonatology and Pediatric Intensive Care Medicine, Children's Hospital, Cologne, Germany.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bührer', 'Affiliation': 'Department of Neonatology, Charité University Medical Center, Berlin, Germany.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Herting', 'Affiliation': 'Department of Pediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15565']
1939,32892493,Efficacy and safety of intralesional injection of vitamin D 3  versus tuberculin PPD in the treatment of plantar warts: A comparative controlled study.,"BACKGROUND


Several destructive and immunotherapeutic methods are used in treatment of plantar warts, but an effective method with no or reduced recurrence has not been found till now.
OBJECTIVES


To evaluate the efficacy and safety of intralesional (IL) vitamin D 3  (Vit.D 3  ) injection vs IL tuberculin purified protein derivative (PPD) injection in the treatment of plantar warts.
METHODS


Sixty patients with plantar warts were randomized into 3 equal groups: group I treated using IL tuberculin PPD every 2 weeks, group II treated using IL Vit.D 3  every 4 weeks, and group III treated with IL saline every 2 weeks till complete clearance or for a maximum of 3 sessions. The follow-up period was 6 months.
RESULTS


There was a statistically significant improvement in therapeutic groups than control with more significant improvement in group II than I. Regarding number of sessions required for complete response, there was a positive significant correlation in both groups, but more significant in group I. There was a negative correlation between the number of lesions and the response to treatment in both groups. Group II showed significantly better response to treatment in male patients. Both modalities were well tolerated, with no remarkable side effects and no recurrence in cured patients of both groups.
CONCLUSIONS


Both IL PPD and Vit.D 3  injection are safe and effective for treatment of plantar warts even recalcitrant or multiple, with no postprocedural downtime, better results, and patient satisfaction. IL Vit.D 3  injection has a superior advantage than PPD.",2020,There was a statistically significant improvement in therapeutic groups than control with more significant improvement in group II than I.,"['Plantar Warts', 'Sixty patients with plantar warts', 'male patients', 'plantar warts']","['IL tuberculin PPD', 'IL saline', 'Intralesional Injection of Vitamin D 3', 'Tuberculin PPD', 'intralesional (IL) vitamin D 3  (Vit D 3  ) injection versus IL tuberculin purified protein derivative (PPD) injection']","['efficacy and safety', 'Efficacy and Safety']","[{'cui': 'C0042548', 'cui_str': 'Verruca plantaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.0243041,There was a statistically significant improvement in therapeutic groups than control with more significant improvement in group II than I.,"[{'ForeName': 'Nahla', 'Initials': 'N', 'LastName': 'Elsayed Ghaly', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Amal Ahmad', 'Initials': 'AA', 'LastName': 'El-Ashmawy', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Abou Zeid', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Engi Seif', 'Initials': 'ES', 'LastName': 'E Shaker', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13712']
1940,32890782,"Letter to the editor regarding: ""a prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study)""-Noriega D, Marcia S, Theumann N, et al.",,2020,,[],['implantable titanium vertebral augmentation device versus balloon kyphoplasty'],[],[],"[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}]",[],,0.0122503,,"[{'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Levy', 'Affiliation': 'Interventional Radiology, Northside Hospital Atlanta, 1000 Johnson Ferry Rd, Atlanta GA 30342. Electronic address: sjlevy@bellsouth.net.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.08.016']
1941,32897014,[Influence of phenazopyridine on the well-being of patients during and after cystoscopy].,"INTRODUCTION


Cystoscopy is one of the most common procedures in urology. There is no single approach to pain relief. In the literature, there are conflicting data on the efficiency of intra-urethral gels. The use of non-steroidal anti-inflammatory drugs, intravenous sedation, and nitric oxide analgesia has been described. Phenazopyridine has been known for a long time. Acting on the bladder mucosa, it has a local analgesic effect. AN evaluation of phenazopyridine intake prior to cystoscopy in order to decrease pain during procedure and facilitate subsequent urination was performed.
MATERIALS AND METHODS


A total of 97 patients were included in the study. Indications for cystoscopy were as following: hematuria, lower urinary tract symptoms/pain, a need to remove ureteral stent. The patients were randomized into two groups. In the main group (n=50), phenazopyridine 200 mg was administered 20 minutes before cystoscopy and then at a dose of 200 mg every 8 hours (in total three doses) in combination with lidocaine gel. In the control group (n=47), only lidocaine gel was used. Heart rate was measured before and after the procedure. All patients were asked to complete a visual analogue scale (VAS) 3, 8 and 24 hours after cystoscopy with the assessment of the first urination.
RESULTS


After cystoscopy, the difference between groups in VAS score was 27.7% in favor of the main group (p<0.001). After 3 hours, the average score in the main group was two times less than in the Control (p=0.012), while 3 and 8 hours after cystoscopy, the proportion of ""zero"" results was 10% and 0%, 28% and 4%, respectively, p<0.005. The heart rate after the procedure in the main group was 75.1 beats/min, compared to 77.9 beats/min in the control group (p=0.016).
CONCLUSION


The intake of phenazopyridine allows to reduce pain intensity during and after cystoscopy and alleviate pain during first urination.",2020,"After 3 hours, the average score in the main group was two times less than in the Control (p=0.012), while 3 and 8 hours after cystoscopy, the proportion of ""zero"" results was 10% and 0%, 28% and 4%, respectively, p<0.005.","['patients during and after cystoscopy', 'A total of 97 patients were included in the study']","['lidocaine gel', 'Phenazopyridine', 'phenazopyridine', 'phenazopyridine intake prior to cystoscopy']","['visual analogue scale (VAS', 'proportion of ""zero"" results', 'VAS score', 'pain relief', 'pain intensity', 'Heart rate', 'heart rate', 'average score', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0031379', 'cui_str': 'Phenazopyridine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",97.0,0.0328551,"After 3 hours, the average score in the main group was two times less than in the Control (p=0.012), while 3 and 8 hours after cystoscopy, the proportion of ""zero"" results was 10% and 0%, 28% and 4%, respectively, p<0.005.","[{'ForeName': 'A Yu', 'Initials': 'AY', 'LastName': 'Tsukanov', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Makushin', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Mirzakadiev', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Zolotov', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
1942,32897015,[Possibilities of using dietary supplements with antioxidant properties in urinary stone disease].,"INTRODUCTION


Dietary supplements are successfully used in many fields of medicine, including urology. In particular, urologists often prescribe dietary supplements for patients with urolithiasis.
AIM


to study an influence of dietary supplements Nefradoz on the metabolism of the main stone-forming substances and inhibitors of stone formation in patients with urolithiasis.
INTRODUCTION


Dietary supplements are successfully used in many fields of medicine, including urology. In particular, urologists often prescribe dietary supplements for patients with urolithiasis.
AIM


to study an influence of dietary supplements Nefradoz on the metabolism of the main stone-forming substances and inhibitors of stone formation in patients with urolithiasis.
MATERIALS AND METHODS


A total of 60 patients with urinary stone diseases were included in a single-center prospective randomized study. All patients were divided into 2 groups of 30 people, depending on the treatment. In the main group, patients followed standard diet, received general recommendations and dietary supplements Nefradoz for 28-30 days, 1 capsule (150 mg) 2 times a day with meals. In the control group, patients received only general recommendations and followed standard diet therapy for 28-30 days. The blood biochemical profile and 24-hour urine analysis were evaluated, as well as a urinalysis was performed on daily basis.
RESULTS


In patients receiving Nefradoz, urinary uric acid excretion increased by 0.9 mmol/day. It must be emphasized that an increase in uric acid excretion did not exceed the upper normal limit. A tendency towards an increase in urine excretion of sodium (by 54 mmol / day), magnesium (by 1 mmol / day) and citrates (by 0.6 mmol / day) was also found. The analysis of urinalysis showed that in the main group, urine specific gravity was lower than in the control group. Higher urine pH in the main group compared to the control group was also shown. The severity of hematuria with the use of Nefradoz was almost two times lower than in patients who did not receive dietary supplement.
CONCLUSION


Considering our data on the ability of dietary supplement Nefradoz to increase the concentration of main inhibitors of stone formation (magnesium and citrates), Nefradoz can be recommended for patients with urinary stone diseases, especially with concomitant hypomagnesuria and hypocitraturia.",2020,"The analysis of urinalysis showed that in the main group, urine specific gravity was lower than in the control group.","['patients with urolithiasis', '60 patients with urinary stone diseases', 'patients with urinary stone diseases', 'urinary stone disease']","['dietary supplements', 'dietary supplements Nefradoz', 'general recommendations and dietary supplements Nefradoz', 'only general recommendations and followed standard diet therapy']","['blood biochemical profile and 24-hour urine analysis', 'urine excretion of sodium', 'urinary uric acid excretion', 'urine specific gravity', 'Higher urine pH', 'uric acid excretion', 'severity of hematuria with the use of Nefradoz']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0042018', 'cui_str': 'Urolith'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0202517', 'cui_str': 'Urinalysis, specific gravity measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042044', 'cui_str': 'Urine pH test'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]",60.0,0.0403146,"The analysis of urinalysis showed that in the main group, urine specific gravity was lower than in the control group.","[{'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Prosiannikov', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Konstantinova', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Golovanov', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Anokhin', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Voitko', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
1943,32918391,A Laboratory-Based Study of the Priming Effects of Food Cues and Stress on Hunger and Food Intake in Individuals with Obesity.,"OBJECTIVE


This study aimed to assess the effects of exposures to food cues and stress on hunger and food intake and examine whether cue responses differ by weight status.
METHODS


In a laboratory-based experimental study, participants (n = 138) were exposed to stress, neutral, and food cues delivered using an individualized script-driven imagery task on three separate days. After each cue exposure, participants ate high- and low-calorie snack foods ad libitum (Food Snack Test). Hunger was measured by visual analog scales.
RESULTS


Food cues elicited significantly greater increases in hunger compared with neutral and stress stimuli. Cue-induced hunger did not differ by weight status. Participants consumed a similar number of total calories across stimuli. In response to food cue provocation, participants with obesity consumed [mean (SE)] 81.0% (4.0%) of calories from high-calorie foods, which was significantly greater than participants with normal weight (63.5%  [3.6%]; P = 0.001). After the stress cue, participants with obesity consumed 81.4% (4.0%) of calories from high-calorie foods, which was significantly more than participants with normal weight (70.2% [3.6%]; P = 0.04). Energy intake from high-calorie foods did not differ by weight status after the neutral cue.
CONCLUSIONS


Among individuals with obesity, exposure to food and stress cues shifted consumption to high-calorie snack foods within a well-controlled experimental setting.",2020,Cue-induced hunger did not differ by weight status.,"['participants (n\u2009=\u2009138', 'Individuals with Obesity']","['Food Cues and Stress', 'stress, neutral, and food cues delivered using an individualized script-driven imagery task']","['Cue-induced hunger', 'Hunger', 'weight status', 'hunger compared with neutral and stress stimuli', 'Hunger and Food Intake', 'normal weight']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}]",138.0,0.0895217,Cue-induced hunger did not differ by weight status.,"[{'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Biobehavioral Health Sciences, University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nia', 'Initials': 'N', 'LastName': 'Fogelman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22952']
1944,32918486,Net benefit index: Assessing the influence of a biomarker for individualized treatment rules.,"One central task in precision medicine is to establish individualized treatment rules (ITRs) for patients with heterogeneous responses to different therapies. Motivated from a randomized clinical trial for Type 2 diabetic patients on a comparison of two drugs, that is, pioglitazone and gliclazide, we consider a problem: utilizing promising candidate biomarkers to improve an existing ITR. This calls for a biomarker evaluation procedure that enables to gauge added values of individual biomarkers. We propose an assessment analytic, termed as net benefit index (NBI), that quantifies a contrast between the resulting gain and loss of treatment benefits when a biomarker enters ITR to reallocate patients in treatments. We optimize reallocation schemes via outcome weighted learning (OWL), from which the optimal treatment group labels are generated by weighted support vector machine (SVM). To account for sampling uncertainty in assessing a biomarker, we propose an NBI-based test for a significant improvement over the existing ITR, where the empirical null distribution is constructed via the method of stratified permutation by treatment arms. Applying NBI to the motivating diabetes trial, we found that baseline fasting insulin is an important biomarker that leads to an improvement over an existing ITR based only on patient's baseline fasting plasma glucose (FPG), age, and body mass index (BMI) to reduce FPG over a period of 52 weeks.",2020,One central task in precision medicine is to establish individualized treatment rules (ITRs) for patients with heterogeneous responses to different therapies.,['Type 2 diabetic patients'],['pioglitazone and gliclazide'],['Net benefit index'],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0265782,One central task in precision medicine is to establish individualized treatment rules (ITRs) for patients with heterogeneous responses to different therapies.,"[{'ForeName': 'Yiwang', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Peter X K', 'Initials': 'PXK', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Haoda', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'Eli Lilly and Company, Lilly Corperate Center, Indianapolis, Indiana.'}]",Biometrics,['10.1111/biom.13373']
1945,32916606,"High-Sensitivity Cardiac Troponin-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women (CODE-MI): Rationale and design for a multicenter, stepped-wedge, cluster-randomized trial.","Despite evidence that high-sensitivity cardiac troponin (hs-cTn) levels in women are lower than in men, a single threshold based on the 99th percentile upper reference limit of the overall reference population is commonly used to diagnose myocardial infarction in clinical practice. This trial aims to determine whether the use of a lower female-specific hs-cTn threshold would improve the diagnosis, treatment, and outcomes of women presenting to the emergency department with symptoms suggestive of myocardial ischemia. METHODS/DESIGN: CODE-MI (hs-cTn-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women) is a multicenter, stepped-wedge, cluster-randomized trial of 30 secondary and tertiary care hospitals across 8 Canadian provinces, with the unit of randomization being the hospital. All adults (≥20 years of age) presenting to the emergency department with symptoms suggestive of myocardial ischemia and at least 1 hs-cTn test are eligible for inclusion. Over five, 5-month intervals, hospitals will be randomized to implement lower female hs-cTn thresholds according to the assay being used at each site. Men will continue to be assessed using the overall thresholds throughout. Women with a peak hs-cTn value between the female-specific and the overall thresholds will form our primary cohort. The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models. The cohort and outcomes will be obtained from routinely collected administrative data. The trial is designed to detect a 20% relative risk difference in the primary outcome, or a 2.2% absolute difference, with 82% power. CONCLUSIONS: This pragmatic trial will assess whether adopting lower female hs-cTn thresholds leads to appropriate assessment of women with symptoms suggestive of myocardial infarction, thereby improving treatment and outcomes.",2020,"The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models.","['30 secondary and tertiary care hospitals across 8 Canadian provinces, with the unit of randomization being the hospital', 'women presenting to the emergency department with symptoms suggestive of myocardial ischemia', 'women with symptoms suggestive of myocardial infarction', 'Women (CODE-MI', 'All adults (≥20\u202fyears of age) presenting to the emergency department with symptoms suggestive of myocardial ischemia and at least 1 hs-cTn test are eligible for inclusion']",[],"['CODE-MI', '1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]",[],"[{'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",30.0,0.331621,"The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models.","[{'ForeName': 'Yinshan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Izadnegahdar', 'Affiliation': 'Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'May K', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Kavsak', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada; Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Scheuermeyer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Department of Emergency Medicine, Vancouver, British Columbia, Canada; St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Udell', 'Affiliation': ""Division of Cardiovascular, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada; Royal Jubilee Hospital, Victoria, British Columbia, Canada.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Norris', 'Affiliation': 'Faculty of Nursing and Division of Cardiovascular Surgery, University of Alberta, Edmonton, Alberta, Canada; Cardiovascular Health and Stroke Strategic Clinical Network, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Lyon', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Saskatchewan Health Authority, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Pilote', 'Affiliation': 'Divisions of General Internal Medicine and Clinical Epidemiology, Department of Medicine, Research Institute of the McGill University Health Centre and McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Jafna', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Ansar', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Division of Cardiovascular Surgery, New Brunswick Heart Centre, Dalhousie University, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Rychtera', 'Affiliation': 'Patient Partners, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Patient Partners, Vernon, British Columbia, Canada.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science and Usher Institute, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Christenson', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Department of Emergency Medicine, Vancouver, British Columbia, Canada; St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Karin H', 'Initials': 'KH', 'LastName': 'Humphries', 'Affiliation': 'BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: karin.humphries@ubc.ca.'}]",American heart journal,['10.1016/j.ahj.2020.06.013']
1946,32919015,The effect of 12-week resistance exercise training on serum levels of cellular aging process parameters in elderly men.,"BACKGROUND


Regular physical activity has a positive effect on the prevention of cellular aging. The present study investigated the effect of 12-week resistance training (RT) on serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme in elderly men.
METHODS


For this purpose, 30 elderly men (age 66.23 ± 0.57 years) were randomly divided into two groups: resistance training group (RET, n = 15) and control group (CTR, n = 15). Participants in RET performed RT protocols with intensity of 60% one-repetition maximum (3×/week, 4 sets of the six exercise circuits). Body composition, physical functioning and, blood samples were assessed before (pre-test) and after (post-test) a 12-week intervention.
RESULTS


The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET. Also, we found a significant difference between the RET and CTR in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.037), PGC1-α (P = 0.007), and telomerase enzyme (P = 0.001).
CONCLUSIONS


12-Week RT increased the levels of proteins associated with the biological aging process in elderly men. It seems that the RT may have beneficial effects on cellular senescence and also improved impaired mitochondrial protein and enzymatic functional induced aging.",2020,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","['elderly men', '30 elderly men (age 66.23\u202f±\u202f0.57\u202fyears']","['12-week resistance training (RT', 'resistance exercise training', 'resistance training group (RET, n\u202f=\u202f15) and control group (CTR']","['PGC1-α', 'RET and CTR in serum levels of SIRT1', 'SIRT6', 'telomerase enzyme', 'serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme', 'SIRT3', 'serum levels of SIRT1', 'Body composition, physical functioning and, blood samples']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C1136177', 'cui_str': 'Silent Mating Type Information Regulator 2-like Proteins'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C2720169', 'cui_str': 'Sirt3'}, {'cui': 'C1452082', 'cui_str': 'PPARGC1A protein, human'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",30.0,0.0157346,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand-Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran; Department of Exercise Physiology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Golestani', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Rezae', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Gaeini', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran, Iran. Electronic address: aagaeini@ut.ac.ir.'}]",Experimental gerontology,['10.1016/j.exger.2020.111090']
1947,32891607,Partial sleep deprivation affects endurance performance and psychophysiological responses during 12-minute self-paced running exercise.,"PURPOSE


This study aimed to investigate the effects of partial sleep deprivation (PSD) on physical performance and psychophysiological responses during 12-minute self-paced running exercise.
METHODS


Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm) performed, in a randomized order, two running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD (bedtime from 00:30 h to 04:30 h). Core temperature and motivation were recorded before exercise. Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 )) were assessed during exercise. Blood lactate concentration [La] was assessed 2 min after exercise. Simple reaction time (SRT), mood and barrage test (BT) were assessed before and after exercise.
RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=-6% for covered distance), following PSD, were obtained compared to CONT. Similarly, PSD attenuated core temperature (p=0.01, d=0.84), HR (p=0.006, ɳp 2 =0.45), VE (p=0.001, ɳp 2 =0.73), VO 2  (p=0.001, ɳp 2 =0.96), BT (p<0.0005, ɳp 2 =0.86), SRT (p=0.0009, ɳp 2 =0.44) and mood (p<0.0005). However, VCO 2 , [La] and motivation score were not affected by sleep conditions.
CONCLUSION


The decrease of running performance and the increase of physical discomfort after PSD could be the origin of the lower cardio-respiratory responses to the 12-minute self-paced exercise. Effective strategies should be introduced to overcome the deterioration of physical performance and physiological responses after PSD.",2020,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","['Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm']","['12-minute self-paced running exercise', 'Partial sleep deprivation', 'running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD', 'partial sleep deprivation (PSD']","['PSD attenuated core temperature', 'running performance', 'SRT', 'VCO 2 , [La] and motivation score', 'physical performance and psychophysiological responses', 'endurance performance and psychophysiological responses', 'Blood lactate concentration [La', 'Simple reaction times (SRT), mood and barrage test (BT', 'Core temperature and motivation', 'Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 ', 'lower physical performance', 'physical discomfort']","[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0445421,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","[{'ForeName': 'Wajdi', 'Initials': 'W', 'LastName': 'Souissi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ayachi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khcharem', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Marco', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Souissi', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France. Electronic address: tarak.driss@parisnanterre.fr.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113165']
1948,32891709,Influence of n-acetylcysteine maintenance on the pharmacodynamic effects of oral ethanol.,"RATIONALE


Glutamate systems play an important role in the abuse related effects of alcohol. n-Acetylcysteine, a drug that promotes glutamate homeostasis, attenuates a range of alcohol effects in preclinical models.
OBJECTIVES


This human laboratory study determined the influence of n-acetylcysteine maintenance on alcohol self-administration using a model predictive of treatment effectiveness, along with the subjective, performance and physiological effects of alcohol. We hypothesized that n-acetylcysteine would attenuate alcohol self-administration, as well as positive subjective effects of alcohol.
METHODS


Nine subjects with alcohol use disorder completed this within-subjects study. Subjects were maintained on placebo, 1.2 and 2.4 g n-acetylcysteine in random order on an outpatient basis. After five days of maintenance on the target dose, subjects completed overnight inpatient experimental sessions in which the pharmacodynamic effects of alcohol were determined.
RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink). n-Acetylcysteine did not alter the effects of alcohol.
CONCLUSIONS


These results indicate that although n-acetylcysteine can safely be combined with alcohol, it does not attenuate the abuse related effects of alcohol and is unlikely to be an effective standalone alcohol use disorder treatment. However, considering study limitations, future work is needed to further understand whether and how n-acetylcysteine might be used as a treatment for alcohol use disorder (e.g., in combination with a behavioral treatment or another pharmacological agent).",2020,"RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink).",['Nine subjects with alcohol use disorder completed this within-subjects study'],"['placebo', 'oral ethanol']","['breath alcohol concentration, increased ratings of Feel Drink']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0202306', 'cui_str': 'Ethanol measurement, breath'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",9.0,0.012153,"RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink).","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA; Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Ave, Lexington, KY 40508, USA. Electronic address: william.stoops@uky.edu.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Lon R', 'Initials': 'LR', 'LastName': 'Hays', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'Abner O', 'Initials': 'AO', 'LastName': 'Rayapati', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Lile', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rush', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.173037']
1949,32896184,"Remdesivir, a remedy or a ripple in severe COVID-19?","INTRODUCTION


In clinical trial for the Ebola virus, the broad-spectrum anti-viral agent remdesivir was shown to have a good safety profile. Remdesivir is now being tested in severe COVID-19.
AREAS COVERED


The Gilead Sciences SIMPLE trial suggests that the short-term use of remdesivir probably does not increase mortality dramatically or have serious short-term toxicity when used to treat severe COVID-19. The Adaptive COVID-19 treatment trials (ACTT1) trial showed that remdesivir may shorten recovery and decrease mortality in severe COVID-19 without increasing adverse effects.
EXPERT OPINION


It seems to me that we have learnt very little from the SIMPLE trial, and this would be predicted from a trial that has no control or placebo group. The results of ACTT1 were reported early after an interim analysis showed that a higher than expected number of recoveries had occurred. There was an indication that remdesivir may be reducing mortality, but this was no statistical significance. The trial is continuing, and the final data are eagerly awaited to determine whether remdesivir is a game-changing remedy or a ripple in the ongoing search for a medicine for the treatment of COVID-19.",2020,"There was an indication that remdesivir may be reducing mortality, but this was not statistical significance.",[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.155191,"There was an indication that remdesivir may be reducing mortality, but this was not statistical significance.","[{'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Doggrell', 'Affiliation': 'Faculty of Health, Queensland University of Technology , Brisbane, Australia.'}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1821645']
1950,32898517,Cardiac autonomic and blood pressure responses to an acute session of battling ropes exercise.,"BACKGROUND


Battling rope (BTR) exercise has become incredibly popular among not only fitness enthusiasts and athletes but in the general exercising population. Despite its popularity, research regarding the acute cardiovascular responses to BTR exercise is limited. This investigation evaluated the effects of acute BTR exercise on heart rate variability (HRV) and blood pressure (BP) responses in young men with elevated BP.
MATERIALS AND METHODS


Eleven young men with elevated BP completed either a BTR or a non-exercise control trial in randomized order. The BTR trial consisted of 10 rounds of BTR exercise. Each round included 30 s of exercise followed by 30 s of rest. HRV and BP were evaluated at baseline and 3, 10, and 30 min following each trial.
RESULTS


There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 min following the BTR trial, whereas no changes from baseline were detected after control. Additionally, there were significant reductions (p ˂0.01) in markers of vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations) for 30 min; as well as (p ˂0.01) systolic BP and diastolic BP at 10 and 30 min after the BTR, but not the control trial.
CONCLUSION


Current findings revealed that BTR exercise elevates sympathovagal balance for 30 min post-intervention, which is concurrent with an impressive hypotensive effect. Further investigations are warranted to assess the potential clinical application of BTR exercise not only in cohorts needing BP control but also in populations with limited locomotion that might benefit from post-exercise hypotension.",2020,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","['young men with elevated BP', 'Eleven young men with elevated BP completed either a']","['Battling rope (BTR) exercise', 'BTR or a non-exercise control', 'acute BTR exercise', 'BTR exercise']","['systolic BP and diastolic BP', 'sympathovagal balance', 'heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF', 'Cardiac Autonomic and Blood Pressure Responses', 'HRV and BP', 'heart rate variability (HRV) and blood pressure (BP) responses', 'vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",11.0,0.10577,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States. Electronic address: awong@marymount.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Bergen', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Allnutt', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113167']
1951,32898690,A nomogram from the SEER database for predicting the prognosis of patients with non-small cell lung cancer.,"OBJECTIVE


The purpose of this study was to establish and validate a nomogram to predict the prognosis in patients with non-small cell lung cancer (NSCLC) from multiple perspectives.
RESULTS


A total of 98,640 eligible patients were randomly divided into a training set (n = 69,048) and a validation set (n = 29,592). The baseline characteristics of the two sets were similar. We used clinical data from patients in the training set for univariate and multivariate Cox regression analyses. Twelve independent risk factors were incorporated for constructed a prognostic nomogram. And the nomogram with a concordance index of 0.777 (95 % CI, 0.775 to 0.779) for overall survival. The calibration curve results showed that the actual survival rate was consistent with the predicted survival rate. The area under curve of the receiver operating characteristic curves demonstrated that the nomogram has a high prediction of the overall survival rate in patients with NSCLC.
CONCLUSION


We have developed a nomogram with high prediction accuracy and discrimination ability, which can help clinicians making personalized survival predictions for NSCLC patients.",2020,"The area under curve of the receiver operating characteristic curves demonstrated that the nomogram has a high prediction of the overall survival rate in patients with NSCLC.
","['98,640 eligible patients', 'NSCLC patients', 'patients with NSCLC', 'patients with non-small cell lung cancer (NSCLC', 'patients with non-small cell lung cancer']",[],"['overall survival rate', 'survival rate', 'actual survival rate', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",98640.0,0.0901438,"The area under curve of the receiver operating characteristic curves demonstrated that the nomogram has a high prediction of the overall survival rate in patients with NSCLC.
","[{'ForeName': 'Bingjie', 'Initials': 'B', 'LastName': 'Zeng', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Ji', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Chenzheng', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Anquan', 'Initials': 'A', 'LastName': 'Shang', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Junlu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Zujun', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China. Electronic address: sunzujun@tongji.edu.cn.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China. Electronic address: lidong@tongji.edu.cn.'}]",The international journal of biochemistry & cell biology,['10.1016/j.biocel.2020.105825']
1952,32898699,N-Glycome changes reflecting resistance to platinum-based chemotherapy in ovarian cancer.,"A number of studies have reported aberrant glycosylation in connection with malignancy. Our investigation further expands on this topic through the examination of N-glycans, which could be associated with the resistance of advanced stage, high-grade non-mucinous ovarian cancer to platinum/taxane based chemotherapy. We used tissue samples of 83 ovarian cancer patients, randomly divided into two independent cohorts (basic and validation). Both groups involved either cases with/without postoperative tumor residue or the cases determined either resistant or sensitive to this chemotherapy. In the validation cohort, preoperative serum samples were also available. N-glycans released from tumors and sera were permethylated and analyzed by matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS). The MS analysis yielded a consecutive detection of 68 (tissue) and 63 (serum) N-glycan spectral signals. Eight of these were found to be differentially abundant in tissues of both independent cohorts including the cases with a postoperative cancer residue. One of these glycans was detected as differentially abundant in sera of the validation cohort. No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort. From the biochemical point of view, the statistically significant N-glycans correspond to the structures carrying bisecting (terminal) GlcNAc residue and tetra-antennary structures with sialic acid and/or fucose residues. Among them, six tissue N-glycans could be considered potential markers connected with a resistance to chemotherapy in ovarian cancer patients. The prediction of primary resistance to standard chemotherapy may identify the group of patients suitable for alternative treatment strategies. SIGNIFICANCE: Drug resistance has become a major impediment to a successful treatment of patients with advanced ovarian cancer. The glycomic measurements related to cancer are becoming increasingly popular in identification of the key molecules as potential diagnostic and prognostic indicators. Our report deals with identification of differences in N-glycosylation of proteins in tissue and serum samples from the individuals showing sensitivity or resistance to platinum/taxane-based chemotherapy. The detection sensitivity to chemotherapy is vitally important for these patients.",2020,No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort.,"['patients with advanced ovarian cancer', 'ovarian cancer', '83 ovarian cancer patients', 'ovarian cancer patients']","['platinum/taxane-based chemotherapy', 'platinum-based chemotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]",[],83.0,0.0192624,No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort.,"[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Zahradnikova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Ihnatova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic; Recetox, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Lattova', 'Affiliation': 'Central European Institute of Technology, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Uhrik', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Eliska', 'Initials': 'E', 'LastName': 'Stuchlikova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Nenutil', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Valik', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Nalezinska', 'Affiliation': 'Department of Gynecologic Oncology, Masaryk Memorial Cancer Institute, Zluty kopec 7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Chovanec', 'Affiliation': 'Department of Gynecologic Oncology, Masaryk Memorial Cancer Institute, Zluty kopec 7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Zbynek', 'Initials': 'Z', 'LastName': 'Zdrahal', 'Affiliation': 'Central European Institute of Technology, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Borivoj', 'Initials': 'B', 'LastName': 'Vojtesek', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Hernychova', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic. Electronic address: lenka.hernychova@mou.cz.'}, {'ForeName': 'Milos V', 'Initials': 'MV', 'LastName': 'Novotny', 'Affiliation': 'Research Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic; Department of Chemistry, Indiana University, 800 E. Kirkwood Avenue, Bloomington, IN 47405, USA. Electronic address: novotny@indiana.edu.'}]",Journal of proteomics,['10.1016/j.jprot.2020.103964']
1953,32899022,Treatment to reduce vascular calcification in hemodialysis patients using vitamin K (Trevasc-HDK): A study protocol for a randomized controlled trial.,"INTRODUCTION


End stage renal failure patients on hemodialysis have significant vascular calcification This is postulated to be related to sub-clinical vitamin K deficiency, which is prevalent in hemodialysis patients. Vitamin K deficiency result in the failure of the matrix GLA protein (MGP) to undergo carboxylation. MGP is a natural local inhibitor of vascular calcification and the lack of functional carboxylated MGP may contribute to increase vascular calcification. Vitamin K supplement should therefore correct this anomaly and decrease the rate or severity of vascular calcification in this population of patients on long-term maintenance hemodialysis. Our study seeks to evaluate the prevalence and the progression of vascular calcification in a cohort of maintenance hemodialysis patients. It will also evaluate the efficacy of vitamin K supplementation in reducing the progression of vascular calcification in this group of patients.
METHODS


This will be a single-center randomized, prospective and open-label interventional clinical trial of end stage renal failure patients on hemodialysis. We aim to recruit 200 patients. Eligible patients will be randomized to either the standard care arm or active treatment arm. Active treatment arm patients will receive standard care plus supplementation with oral vitamin K2 isoform 360 mcg 3 times weekly for a total duration of 18 months. Primary outcome measured will be absolute difference in coronary artery calcification score at 18-month between control and intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular over the same period.
DISCUSSION


Evidence of successful regression or retardation of vascular calcification will support the conduct of larger and longer-term trials aimed at reducing cardiovascular disease mortality and major adverse cardiovascular events in this high-risk population using a safe and inexpensive strategy TRIAL REGISTRATION:: ClinicalTrials.gov NCT02870829. Registered on 17 August 2016 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02870829National University Hospital's Institutional Review Board (2015/01000).",2020,"INTRODUCTION


End stage renal failure patients on hemodialysis have significant vascular calcification","['Eligible patients', 'hemodialysis patients', 'hemodialysis patients using', 'Registered on 17 August 2016 ', 'maintenance hemodialysis patients', 'stage renal failure patients on hemodialysis', '200 patients']","['standard care plus supplementation with oral vitamin K2 isoform', 'vitamin K supplementation', 'Vitamin K supplement', 'MGP', 'vitamin K (Trevasc-HDK']","['rate or severity of vascular calcification', 'coronary artery calcification score', 'progression of vascular calcification', 'aortic valve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular over the same period', 'vascular calcification']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C3661606', 'cui_str': 'Vitamin K supplement'}, {'cui': 'C0065752', 'cui_str': 'matrix Gla protein'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0428791', 'cui_str': 'Aortic valve calcification'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.160604,"INTRODUCTION


End stage renal failure patients on hemodialysis have significant vascular calcification","[{'ForeName': 'Sabrina-Wong-Peixin', 'Initials': 'SW', 'LastName': 'Haroon', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Bee-Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health.'}, {'ForeName': 'Lieng-Hsi', 'Initials': 'LH', 'LastName': 'Ling', 'Affiliation': 'National University Heart Center.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Teo', 'Affiliation': 'Department of Diagnostic Imaging, National University Hospital, Singapore.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davenport', 'Affiliation': 'UCL Centre for Nephrology, Royal Free Hospital, University College London, United Kingdom.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Schurgers', 'Affiliation': 'Department of Biochemistry, Cardiovascular Research Institute Maastricht, The Netherlands.'}, {'ForeName': 'Boon-Wee', 'Initials': 'BW', 'LastName': 'Teo', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Khatri', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Ching-Ching', 'Initials': 'CC', 'LastName': 'Ong', 'Affiliation': 'Department of Diagnostic Imaging, National University Hospital, Singapore.'}, {'ForeName': 'Sanmay', 'Initials': 'S', 'LastName': 'Low', 'Affiliation': 'Department of Medicine, Ng Teng Fong General Hospital.'}, {'ForeName': 'Xi-Er', 'Initials': 'XE', 'LastName': 'Yeo', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Jia-Neng', 'Initials': 'JN', 'LastName': 'Tan', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Subramanian', 'Affiliation': 'Kidney and Medical Clinic Pte Ltd, Parkway East Hospital.'}, {'ForeName': 'Horng-Ruey', 'Initials': 'HR', 'LastName': 'Chua', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Swee-Yaw', 'Initials': 'SY', 'LastName': 'Tan', 'Affiliation': 'National Heart Center Singapore, Singapore.'}, {'ForeName': 'Weng-Kin', 'Initials': 'WK', 'LastName': 'Wong', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Titus-Wai-Leong', 'Initials': 'TW', 'LastName': 'Lau', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}]",Medicine,['10.1097/MD.0000000000021906']
1954,32899030,"Efficacy and safety of thread embedding acupuncture on knee osteoarthritis: A randomized, controlled, pilot clinical trial.","INTRODUCTION


Although there are various therapeutic methods for the treatment of knee osteoarthritis, each has its advantages and shortcomings, and a definitive treatment method is yet to be determined. This pilot study is designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of thread embedding acupuncture (TEA) with polydioxanone thread in knee osteoarthritis patients.
METHODS AND ANALYSIS


This study is a clinical trial to evaluate the efficacy and safety of TEA for knee osteoarthritis. Forty participants will be recruited at the hospital and after randomization into 2 groups of 20 (experimental and control); they will be treated for 6 weeks. The experimental group will receive TEA treatment 6 times (1 time/week) in 6 weeks on 14 defined knee areas, and the control group, acupuncture treatments 12 times (2 times/week) in 6 weeks on 9 defined acupuncture points. The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment. The follow-ups before clinical trial, 3 weeks after procedure, 6 weeks after procedure, and 4 weeks after the end of procedure will be done to compare the degree of pain with the control group, which received the acupuncture treatment.
CONCLUSION


The trial based on this study will provide clinical information on the efficacy and safety of TEA treatment on knee osteoarthritis.
TRIAL REGISTRATION NUMBER


KCT0004844.",2020,"The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment.","['knee osteoarthritis', 'Forty participants will be recruited at the hospital and after randomization into 2 groups of 20 (experimental and control', 'knee osteoarthritis patients']","['thread embedding acupuncture', 'polydioxanone', 'acupuncture', 'TEA', 'acupuncture treatment', 'thread embedding acupuncture (TEA']","['visual analogue scale (VAS', 'efficacy and safety', 'Efficacy and safety']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0085242', 'cui_str': 'Polydioxanone'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",40.0,0.0681454,"The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment.","[{'ForeName': 'Purumea', 'Initials': 'P', 'LastName': 'Jun', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Chang-Hyun', 'Initials': 'CH', 'LastName': 'Han', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Chang Sop', 'Initials': 'CS', 'LastName': 'Yang', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Min Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jae Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.'}, {'ForeName': 'Cho In', 'Initials': 'CI', 'LastName': 'Lee', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.'}, {'ForeName': 'Jung Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.'}, {'ForeName': 'Chung A', 'Initials': 'CA', 'LastName': 'Park', 'Affiliation': 'Department of Diagnostics, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.'}, {'ForeName': 'Young Joon', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, College of Korean Medicine, Daegu Haany University, Gyeongsan, Republic of Korea.'}, {'ForeName': 'Hyun-Jong', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000021957']
1955,32899031,Clinical efficacy and imaging evaluation of recombinant tissue plasminogen activator thrombolytic therapy in patients with wake up stroke: A randomized controlled trial.,"INTRODUCTION


Wake up stroke starts in sleep and is a more common form of ischemic stroke. At present, it is still controversial whether wake up stroke can be treated with thrombolytic therapy. Therefore, this study will combine imaging techniques to assess the onset time of wake up stroke patients, and to analyze the imaging characteristics of wake up stroke patients and patients suitable for thrombolytic therapy within the time window.
METHODS/DESIGN


This study will be a single-blinded, randomized controlled trial with 2 parallel groups. It will be conducted at North China University of science and technology affiliated hospital.
DISCUSSION


There is no consistent conclusion about the pathogenesis of wake up stroke. Wake up stroke is more likely to manifest as small vessel disease. The incidence of wake up stroke patients is relatively high, and the effectiveness and safety of intravenous thrombolysis under the guidance of multimode imaging therapy in wake up stroke need to be further explored by prospective, large-scale studies.
TRIAL REGISTRATION


ClinicalTrials.gov, ChiCTR2000034402, Registered on 05 July 2020.",2020,"The incidence of wake up stroke patients is relatively high, and the effectiveness and safety of intravenous thrombolysis under the guidance of multimode imaging therapy in wake up stroke need to be further explored by prospective, large-scale studies.
",['patients with wake up stroke'],['recombinant tissue plasminogen activator thrombolytic therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}]",[],,0.179453,"The incidence of wake up stroke patients is relatively high, and the effectiveness and safety of intravenous thrombolysis under the guidance of multimode imaging therapy in wake up stroke need to be further explored by prospective, large-scale studies.
","[{'ForeName': 'Chun-Yang', 'Initials': 'CY', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yan-Ling', 'Initials': 'YL', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Cui-Lan', 'Initials': 'CL', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021958']
1956,32899037,"Long-term safety and efficacy of mirogabalin in Asian patients with postherpetic neuralgia: Results from an open-label extension of a multicenter randomized, double-blind, placebo-controlled trial.","OBJECTIVE


Postherpetic neuralgia (PHN) is a condition that results from nerve dysfunction following an episode of acute herpes zoster (shingles). Mirogabalin is a novel, selective oral α2δ ligand that demonstrated safety and efficacy in a multicenter, randomized, double-blind, placebo-controlled 14-week study in Asian patients with PHN. This 52-week, open-label extension study investigated the long-term safety and efficacy of flexible-dosage mirogabalin in Asian patients with PHN.
METHODS


This open-label extension study enrolled patients who completed the placebo-controlled study. Patients started with a dose of 5 mg mirogabalin twice daily (BID), which was followed by a flexible dose of 10 or 15 mg BID. During the study, patients assessed their pain using the Short-Form McGill Pain Questionnaire (SF-MPQ). Adverse events were monitored throughout the study.
RESULTS


Of 239 enrolled patients, 184 (77.0%) completed the study and 185 patients (77.4%) received the 15 mg BID dose most during the treatment duration. Most treatment-emergent adverse events (TEAEs) were mild or moderate. The most common TEAEs were nasopharyngitis, somnolence, dizziness, weight increased, and edema. All SF-MPQ scales decreased from baseline to week 52.
CONCLUSIONS


This study showed the safety and stable pain management of a long-term flexible dosing regimen of mirogabalin 10 or 15 mg twice daily for 52 weeks in patients with PHN. CLINICAL TRIAL REGISTERED AT CLINICALTRIALS.GOV:: NCT02318719.
SUMMARY FOR TABLE OF CONTENTS


Mirogabalin-a novel α2δ oral ligand-was shown to be effective and well tolerated for treating postherpetic neuralgia (PHN) in an Asian multicenter, randomized, double-blind, placebo-controlled, 14-week study. This open-label, 52-week study was conducted as an extension of the double-blind study to demonstrate long-term safety and efficacy of mirogabalin.",2020,"All SF-MPQ scales decreased from baseline to week 52.
","['Asian patients with postherpetic neuralgia', 'Of 239 enrolled patients, 184 (77.0%) completed the study and 185 patients (77.4', 'patients with PHN', 'Asian patients with PHN']","['flexible-dosage mirogabalin', 'placebo', 'mirogabalin']","['All SF-MPQ scales', 'safety and stable pain management', 'Adverse events', 'pain using the Short-Form McGill Pain Questionnaire (SF-MPQ', 'nasopharyngitis, somnolence, dizziness, weight increased, and edema']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4043827', 'cui_str': 'mirogabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",239.0,0.349162,"All SF-MPQ scales decreased from baseline to week 52.
","[{'ForeName': 'Jitsu', 'Initials': 'J', 'LastName': 'Kato', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine.'}, {'ForeName': 'Norimitsu', 'Initials': 'N', 'LastName': 'Matsui', 'Affiliation': 'Clinical Development Department.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kakehi', 'Affiliation': 'Clinical Development Department.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Murayama', 'Affiliation': 'Asia Development Department.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Ohwada', 'Affiliation': 'Biostatistics and Data Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}]",Medicine,['10.1097/MD.0000000000021976']
1957,32899045,Clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by Qishe pill.,"BACKGROUND


Cervical spondylotic myelopathy (CSM) is the most serious type of cervical spondylosis, which is often treated surgically in patients with progressive neurological symptoms following ineffective conservative treatment. However, some patients have residual symptoms such as neck pain, stiffness, and C5 nerve palsy after surgery. The Qishe pill can effectively relieve the symptoms of neck pain and numbness, but there is no evidence showing the efficacy and safety of the Qishe pill in treating symptoms after spinal cord surgery.
METHODS/DESIGN


A multicenter, randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the Qishe Pill. A total of 330 patients with CSM who receive surgical treatment will be randomly divided into 2 groups, treated for 12 weeks and with a 1-year follow-up. The primary outcome will be Japanese Orthopaedic Association score from the baseline to 4 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery. Secondary outcomes will include Visual Analogue Scale score, Neck Disability Index, and imaging indicators (including magnetic resonance imaging and X-ray). Additionally, adverse reactions will be observed and recorded as safety indicators.
DISCUSSION


Although the Qishe pill can effectively improve the discomfort of the neck and upper limbs in clinical applications, there is a lack of clinical research on postoperative patients. This study will investigate the efficacy and safety of the Qishe pill in treating postoperative symptoms of CSM.
TRIAL REGISTRATION


Clinical Trials.gov ID: ChiCTR1900028173. Registered on 17 December 2019.",2020,"The Qishe pill can effectively relieve the symptoms of neck pain and numbness, but there is no evidence showing the efficacy and safety of the Qishe pill in treating symptoms after spinal cord surgery.
","['330 patients with CSM who receive surgical treatment', 'patients with progressive neurological symptoms following ineffective conservative treatment']","['Cervical spondylotic myelopathy (CSM', 'Qishe pill']","['adverse reactions', 'efficacy and safety', 'Japanese Orthopaedic Association score', 'Visual Analogue Scale score, Neck Disability Index, and imaging indicators (including magnetic resonance imaging and X-ray']","[{'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]",330.0,0.17859,"The Qishe pill can effectively relieve the symptoms of neck pain and numbness, but there is no evidence showing the efficacy and safety of the Qishe pill in treating symptoms after spinal cord surgery.
","[{'ForeName': 'Jinhai', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chongqing', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Jin', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Junming', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Xuequn', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Mo', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, Shanghai, China.'}]",Medicine,['10.1097/MD.0000000000021994']
1958,32915027,Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation.,"The current opioid crisis was fueled by escalation of opioid dosing among patients with chronic pain. Yet, there are few evidence-based psychological interventions for opioid dose reduction among chronic pain patients treated with long-term opioid analgesics. Mindfulness-Oriented Recovery Enhancement (MORE), which was designed to target mechanisms underpinning chronic pain and opioid misuse, has shown promising results in 2 randomized clinical trials (RCTs) and could facilitate opioid sparing and tapering by bolstering self-regulation. Here we tested this hypothesis with secondary analyses of data from a Stage 2 RCT. Chronic pain patients (N = 95) on long-term opioid therapy were randomized to 8 weeks of MORE or a support group (SG) control delivered in primary care. Opioid dose was assessed with the Timeline Followback through 3-month follow-up. Heart rate variability (HRV) during mindfulness meditation was quantified as an indicator of self-regulatory capacity. Participants in MORE evidenced a greater decrease in opioid dosing (a 32% decrease) by follow-up than did the SG, F(2, 129.77) = 5.35, p = .006, d = 1.07. MORE was associated with a significantly greater increase in HRV during meditation than was the SG. Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034). MORE may boost self-regulatory strength via mindfulness and thereby facilitate self-control over opioid use, leading to opioid dose reduction in people with chronic pain. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034).,"['people with chronic pain', 'chronic pain patients treated with long-term opioid analgesics', 'Chronic pain patients (N = 95) on long-term opioid therapy', 'patients with chronic pain']","['MORE or a support group (SG) control delivered in primary care', 'Mindfulness-Oriented Recovery Enhancement (MORE']","['Heart rate variability (HRV', 'HRV']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0780555,Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034).,"[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hudak', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}]",The American psychologist,['10.1037/amp0000638']
1959,32909468,"Effects of Resistance Exercise on Symptoms, Physical Function, and Quality of Life in Gastrointestinal Cancer Patients Undergoing Chemotherapy.","This research aimed to investigate the effects of resistance exercise on symptoms, physical function, and quality of life (QoL) in gastrointestinal cancer patients undergoing chemotherapy. Patients were quasi-randomly divided into the resistance exercise group and the relaxation control group, and machine-based resistance exercise was performed twice a week for 12 weeks under the guidance of experienced therapists. The QoL of patients was analyzed by EORTC-QLQ-C30. Resistance exercise training significantly reduced the incidences of lack of energy (inter-group  P  = .011), nausea (inter-group  P  = .007), acid reflux (inter-group  P  = .042), and back pain (inter-group  P  = .0009). Twelve weeks of resistance exercise training significantly elevated the muscular strength of leg press (inter-group  P  = .021) and leg extension (inter-group  P  = .041), and the muscular endurance of leg press (inter-group  P  = .005). The participants' performance in 6-m fast walk (inter-group  P  = .008), 6-m backwards walk (inter-group  P  = .016), and chair rise (inter-group  P  = .031) were dramatically improved. Fatigue (inter-group  P  = .024) and appetite loss (inter-group  P  = .012) in the resistance exercise group were significantly lower than the relaxation control group. In conclusion, the beneficial effects of resistance exercise on symptoms, physical function and QoL in gastrointestinal cancer patients undergoing chemotherapy were demonstrated. Resistance exercise training reduced the incidences of nausea and acid reflux, improved physical function, and alleviated fatigue and appetite loss in gastrointestinal cancer patients undergoing chemotherapy.",2020,"Twelve weeks of resistance exercise training significantly elevated the muscular strength of leg press (inter-group  P  = .021) and leg extension (inter-group  P  = .041), and the muscular endurance of leg press (inter-group  P  = .005).","['gastrointestinal cancer patients undergoing chemotherapy', 'Gastrointestinal Cancer Patients Undergoing Chemotherapy']","['Resistance Exercise', 'resistance exercise', 'Resistance exercise training', 'resistance exercise group and the relaxation control group, and machine-based resistance exercise', 'resistance exercise training']","['leg extension', 'symptoms, physical function, and quality of life (QoL', 'muscular endurance of leg press', 'chair rise', 'Symptoms, Physical Function, and Quality of Life', 'acid reflux', 'symptoms, physical function and QoL', 'appetite loss', 'nausea', 'back pain', 'muscular strength of leg press', 'nausea and acid reflux, improved physical function, and alleviated fatigue and appetite loss', 'incidences of lack of energy', 'Fatigue']","[{'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0236166,"Twelve weeks of resistance exercise training significantly elevated the muscular strength of leg press (inter-group  P  = .021) and leg extension (inter-group  P  = .041), and the muscular endurance of leg press (inter-group  P  = .005).","[{'ForeName': 'Yijin', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Biyu', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}]",Integrative cancer therapies,['10.1177/1534735420954912']
1960,32909491,Building Capacity for Medication Assisted Treatment in Rural Primary Care Practices: The IT MATTTRs Practice Team Training.,"OBJECTIVES


In response to rural communities and practice concerns related to opioid use disorder (OUD), the Implementing Technology and Medication Assisted Treatment Team Training in Rural Colorado study (IT MATTTRs) developed a training intervention for full primary care practice (PCP) teams in MAT for OUD. This evaluation reports on training implementation, participant satisfaction, and impact on perceived ability to deliver MAT.
METHODS


PCPs in the High Plains Research Network and Colorado Research Network were randomized to receive team training either in-person or through virtual tele-mentoring. Training attendance logs recorded the number of participants and their roles. Participants completed a survey within one month of the last training session to evaluate satisfaction and ability to deliver components of MATs.
RESULTS


441 team members at 42 PCPs were trained, including 22% clinicians, 47% clinical support staff, 24% administrative support staff. Survey respondents reported high levels of satisfaction, including 82% reporting improved understanding of the topic, and 68% identifying actions to apply information. Self-rated ability was significantly higher after training for all items ( P  < .0001), including ability to identify patients for MAT and to manage patients receiving MAT. Mean change scores, adjusted for role, were significantly greater for all measures ( P  < .001) in SOuND practices compared to ECHO practices.
CONCLUSIONS


The IT MATTTRs Practice Team Training successfully engaged PCP team members in diverse roles in MAT for OUD training and increased self-efficacy to deliver MAT. Results support the training as a resource for a team-based approach to build rural practices' capacity to deliver MAT.",2020,"Self-rated ability was significantly higher after training for all items ( P  < .0001), including ability to identify patients for MAT and to manage patients receiving MAT.","['441 team members at 42 PCPs were trained, including 22% clinicians, 47% clinical support staff, 24% administrative support staff', 'PCPs in the High Plains Research Network and Colorado Research Network', 'Rural Primary Care Practices']",['team training either in-person or through virtual tele-mentoring'],"['Self-rated ability', 'Mean change scores']","[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",441.0,0.0358636,"Self-rated ability was significantly higher after training for all items ( P  < .0001), including ability to identify patients for MAT and to manage patients receiving MAT.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zittleman', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Curcija', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Sutter', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Dionisia', 'Initials': 'D', 'LastName': 'de la Cerda', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Nease', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Westfall', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}]",Journal of primary care & community health,['10.1177/2150132720953723']
1961,32911306,Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study.,"BACKGROUND


In the phase 3 TOWER core study (NCT00751881), the efficacy and safety of teriflunomide compared with placebo were demonstrated in patients with relapsing forms of multiple sclerosis (RMS). Here, the long-term safety and efficacy outcomes from the TOWER extension study (NCT00751881) are reported.
METHODS


All patients who entered the extension (N = 751) were assigned to teriflunomide 14 mg and assessed for long-term safety and efficacy.
RESULTS


Of 751 patients in the TOWER extension study, 253, 265, and 233 patients received placebo/teriflunomide 14 mg, teriflunomide 7 mg/14 mg, and teriflunomide 14 mg/14 mg, respectively. Median teriflunomide exposure was 4.25 years (maximum 6.3 years). The overall frequency of adverse events (AEs) was comparable across treatment groups, but a higher proportion of patients in the teriflunomide 7 mg/14 mg (12.4%) and 14 mg/14 mg (12.4%) groups had serious AEs compared with the placebo/teriflunomide 14 mg group (6.4%). Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively). The incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy) were low and comparable across treatment arms. Disability worsening and adjusted annualized relapse rates were low and stable over time, and mean Expanded Disability Status Scale scores were unchanged over time, for all treatment groups.
CONCLUSION


In the TOWER extension study, the efficacy of teriflunomide 14 mg was maintained in patients with RMS. No new or unexpected AEs were observed with teriflunomide treatment, supporting a safety profile in the extension that was consistent with the core trial. These findings support the positive benefit:risk profile of teriflunomide as a long-term immunomodulatory therapy.",2020,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","['All patients who entered the extension', '751 patients in the TOWER extension study, 253, 265, and 233 patients received', 'patients with relapsing forms of multiple sclerosis (RMS', 'patients with relapsing multiple sclerosis', 'patients with RMS']","['placebo/teriflunomide 14\xa0mg, teriflunomide', 'placebo', 'placebo/teriflunomide', 'teriflunomide']","['incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy', 'efficacy and safety', 'Disability worsening and adjusted annualized relapse rates', 'Median teriflunomide exposure', 'mean Expanded Disability Status Scale scores', 'Alanine aminotransferase increase and hair thinning', 'overall frequency of adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3497716', 'cui_str': 'teriflunomide 14 MG'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}, {'cui': 'C0020678', 'cui_str': 'Hypotrichosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",751.0,0.0571361,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","[{'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, 5 East 98th Street-Box 1138, New York, NY, 10029, United States. Electronic address: aaron.miller@mssm.edu.'}, {'ForeName': 'Tomas P', 'Initials': 'TP', 'LastName': 'Olsson', 'Affiliation': 'Neuroimmunology Unit, Department of Clinical Neuroscience, Karolinska Institutet, Center for Molecular Medicine, L8:04, Karolinska Hospital, 17176 Stockholm, Sweden.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), 6431 Fannin Street, Houston, TX, 77030, United States.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Petersgraben 4, CH-4031 Basel, Switzerland.'}, {'ForeName': 'Xueqiang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Neurology, Hospital of Sun Yat-Sen University, 107 Yan Jiang West Road, Guangzhou, China.'}, {'ForeName': 'Xianhao', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Beijing Hospital, No. 1 Dahua Road, Beijing, China.'}, {'ForeName': 'Alex L', 'Initials': 'AL', 'LastName': 'Lublin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Truffinet', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Chavin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Delhay', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Benamor', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Purvis', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'The Ottawa Hospital Ontario, 501 Smyth Road, Box 601, Ottawa, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102438']
1962,32911319,"A randomized pilot study assessing the acceptability of rapid point-of-care hepatitis C virus (HCV) testing among male inmates in Montreal, Canada.","BACKGROUND


The Oraquick Ⓡ  fingerprick point-of-care hepatitis C virus antibody (HCV-Ab) test is favoured to venipuncture among people who inject drugs; however, its acceptability in prison populations is unknown. We aimed to compare the acceptability of the Oraquick Ⓡ  versus standard venipuncture among people in prison.
METHODS


From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation. The remaining 78 were randomized 1:1 to opt-out HCV-Ab screening with OraQuick Ⓡ  or venipuncture (n = 39 each). Acceptability was determined by the proportion accepting to undergo screening.
RESULTS


The majority of participants (median age 33 years) reported a history of drug use (76%; 8% injection drug use); 47% perceived their HCV risk to be moderate/high. All inmates randomized to Oraquick Ⓡ  accepted testing while 87% accepted venipuncture. Among those who accepted Oraquick Ⓡ  vs. venipuncture, 100% vs. 97% were satisfied with the test, 97% vs. 94% would recommend the same test, and 100% vs. 76% would choose the same test again.
CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.",2020,"CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.","[""From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation"", 'people in prison', 'male inmates in Montreal, Canada', 'Adult incarcerated men in Canada']","['rapid point-of-care hepatitis C virus (HCV', 'venipuncture', 'Ⓡ  or venipuncture', 'HCV-Ab screening with OraQuick', 'Oraquick Ⓡ  versus standard venipuncture']",['Acceptability'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",280.0,0.0431789,"CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kronfli', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: nadine.kronfli@mcgill.ca.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Dussault', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chalifoux', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Hasmig', 'Initials': 'H', 'LastName': 'Kavoukian', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Marina B', 'Initials': 'MB', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; CIHR Canadian HIV Trials Network, Vancouver, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102921']
1963,32896644,Transcranial direct current stimulation: A novel approach in the treatment of vascular depression.,"BACKGROUND


Despite the impact of depression in terms of personal suffering and socioeconomic burden, most currently available treatment options are often ineffective. A particularly difficult-to-treat depressive disorder characteristic of the elderly is vascular depression, a late-life depressive syndrome related to a variety of potential vascular mechanisms. Transcranial Direct Current Stimulation (tDCS), a non-invasive and effective somatic approach to depression, also showed positive effects on cognitive deficits.
AIM


We performed a double-blind randomized study to investigate the efficacy of tDCS as augmentation strategy to sertraline in the treatment of vascular depression, hypothesizing a positive effect in both depressive symptoms and cognitive functions.
METHODS


We enrolled 93 inpatients over 60 years of age with a diagnosis of vascular depression. Depressive symptoms were weekly assessed (T0, T1, T2) with the 21-items Hamilton depression rating scale (HDRS). Cognitive functioning was evaluated with the Milan Overall Dementia Assessment (MODA) at baseline and after the treatment protocol. All patients were randomly assigned into three groups, Group I: one tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day. Stimulation was performed for 10 consecutive working days.
RESULTS


A significant interaction time∗treatment was observed on HDRS scores (F = 14, p < 0.001). All groups improved at T1 but whereas Group II significantly differed from the Sham group (p < 0.001) we observed no difference between Sham and Group I. At T2 all groups improved but Group II showed the greater improvement (vs. Sham p < 0.001; vs. Group I p < 0.001) and the Sham group the smallest (vs. Group I p = 0.005). A significant interaction time∗treatment was also observed on MODA scores (F = 3.31, p = 0.04). Only subjects treated with tDCS improved at T2 (Group I: p < 0.001; Group II: p = 0.007). However, no difference between Group I and II was shown.
CONCLUSION


tDCS as augmentation treatment of an adequate pharmacotherapy is a potential strategy in the management of vascular depression, a disease known to be often unresponsive to antidepressants only. Non-invasiveness, the absence of severe side effects and the possibility of administering it to outpatients at an affordable price make tDCS an important tool in clinical practice.",2020,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,['93 inpatients over 60 years of age with a diagnosis of vascular depression'],"['sertraline', 'tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day', 'Transcranial Direct Current Stimulation (tDCS', 'Transcranial direct current stimulation', 'tDCS']","['MODA scores', 'Depressive symptoms', '21-items Hamilton depression rating scale (HDRS', 'HDRS scores']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",93.0,0.13066,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,"[{'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Zanardi', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy. Electronic address: zanardi.raffaella@hsr.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Poletti', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prestifilippo', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Attanasio', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barbini', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Mood Disorder Unit, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}]",Brain stimulation,['10.1016/j.brs.2020.08.013']
1964,32896743,Development of a brief online intervention to address aggression in the context of emotion-related impulsivity: Evidence from a wait-list controlled trial.,"Trait-like tendencies to respond impulsively to emotion, labelled emotion-related impulsivity, are robustly related to aggression. We developed and tested an online intervention to address emotion-related impulsivity and aggression. The 6-session intervention focused on behavioral techniques shown to decrease arousal and aggression, supplemented with implementation intentions and smartphone prompts to facilitate skills transfer into daily life. First, we piloted the intervention in-person with 4 people. Then, 235 participants were randomly assigned to take the online intervention immediately or after a wait-list period; those in the waitlist were then invited to take part in the intervention. Participants completed the self-rated Feelings Trigger Action Scale to assess emotion-related impulsivity, the interview-based Modified Overt Aggression Scale and the self-rated Buss Perry Aggression Questionnaire. Participants who took part in the treatment completed daily anger logs. Attrition, as with other online programs, was high; however, treatment completers reported high satisfaction, and outcomes changed more rapidly during treatment than waitlist across all key outcome indices. In analyses including all participants who took part in the treatment (immediate or delayed), we observed moderate-to-large treatment gains, which were maintained as of the 3-month follow-up assessment. This work supports the usefulness of an intervention for addressing emotion-related impulsivity and aggression.",2020,"Attrition, as with other online programs, was high; however, treatment completers reported high satisfaction, and outcomes changed more rapidly during treatment than waitlist across all key outcome indices.","['Participants who took part in the treatment completed daily anger logs', '235 participants']",['brief online intervention'],"['self-rated Feelings Trigger Action Scale to assess emotion-related impulsivity, the interview-based Modified Overt Aggression Scale and the self-rated Buss Perry Aggression Questionnaire']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",235.0,0.0388093,"Attrition, as with other online programs, was high; however, treatment completers reported high satisfaction, and outcomes changed more rapidly during treatment than waitlist across all key outcome indices.","[{'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'University of California Berkeley, USA. Electronic address: sljohnson@berkeley.edu.'}, {'ForeName': 'Mackenzie Rae', 'Initials': 'MR', 'LastName': 'Zisser', 'Affiliation': 'University of California Berkeley, USA.'}, {'ForeName': 'Devon B', 'Initials': 'DB', 'LastName': 'Sandel', 'Affiliation': 'University of California Berkeley, USA.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Swerdlow', 'Affiliation': 'University of California Berkeley, USA.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Carver', 'Affiliation': 'University of Miami, USA.'}, {'ForeName': 'Amy H', 'Initials': 'AH', 'LastName': 'Sanchez', 'Affiliation': 'University of California Berkeley, USA.'}, {'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Fernandez', 'Affiliation': 'University of Texas San Antonio, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103708']
1965,32897319,"Feasibility and Acceptability of an Abbreviated, Four-Week Mindfulness Program for Chronic Pain Management.","OBJECTIVE


The Mindfulness-Based Stress Reduction program is effective at improving chronic pain outcomes, but the time demand hinders participation. This preliminary study evaluated the feasibility, acceptability, and potential effects of providing an abbreviated mindfulness program for patients with chronic pain.
DESIGN


A single-arm, mixed-methods, pre-post intervention study.
SETTING


An outpatient rehabilitation clinic at an academic medical center.
SUBJECTS


Participants were N = 23 adults with chronic pain who were new to mindfulness practice.
METHODS


Mindfulness-based Stress Reduction was adapted to shorten the program to four weekly 90-minute sessions and to focus content on pain management. Three cohorts of six to nine participants completed baseline and post-treatment measures of 1) patient-reported outcomes, including pain intensity, pain interference, physical functioning, depressive/anxiety symptoms, positive affect and well-being, and sleep disturbance; 2) pain medication dosages; 3) psychosocial variables including pain acceptance, pain catastrophizing, and perceived stress; 4) dispositional mindfulness, as well as postintervention structured interviews about their experiences.
RESULTS


Acceptable rates of retention and attendance and high ratings of satisfaction indicated that the intervention was feasible and acceptable. In interviews, participants found the program acceptable and beneficial and provided suggestions to improve it. From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
CONCLUSIONS


In adults with chronic pain, a four-week mindfulness program is feasible and acceptable, addresses the barrier of a lengthy program, and may improve quality of life and psychological functioning. An appropriately powered randomized controlled trial with a comparison group is needed to assess the intervention's effectiveness.",2020,"From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
","['Participants were N = 23 adults with chronic pain who were new to mindfulness practice', 'Chronic Pain Management', 'adults with chronic pain', 'An outpatient rehabilitation clinic at an academic medical center', 'patients with chronic pain']","['abbreviated mindfulness program', 'Abbreviated, Four-Week Mindfulness Program', 'Mindfulness-Based Stress Reduction program']","['Feasibility and Acceptability', 'physical functioning and anxiety', 'quality of life and psychological functioning', 'pain intensity, pain interference, physical functioning, depressive/anxiety symptoms, positive affect and well-being, and sleep disturbance; 2) pain medication dosages; 3) psychosocial variables including pain acceptance, pain catastrophizing, and perceived stress; 4) dispositional mindfulness, as well as postintervention structured interviews about their experiences', 'retention and attendance and high ratings of satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",23.0,0.0312875,"From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
","[{'ForeName': 'Carrie E', 'Initials': 'CE', 'LastName': 'Brintz', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Roth', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Keturah', 'Initials': 'K', 'LastName': 'Faurot', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Gaylord', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa208']
1966,32681911,Effects of Induced Astigmatism on Spectral Domain-OCT Angiography Quantitative Metrics.,"PURPOSE


To analyze the effect of induced astigmatism on en-face spectral-domain optical coherence tomography angiography quantitative metrics.
DESIGN


Prospective crossover study.
METHODS


Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a 3 × 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA). Quantitative parameters, including foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD) were corrected for magnification secondary to axial length and analyzed. Univariate linear regressions were performed within each eye to correlate quantitative metrics to the level of an induced astigmatic cylinder.
RESULTS


Fifteen eyes from 15 patients were imaged. Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001). For every 1-D increase in induced astigmatism, the resulting decrease in the inner ring superior quadrant was 12% greater for VD and 16% greater for PD versus that in the inferior quadrant. The resulting decrease in the inner ring nasal quadrant was 40% greater for VD and 48% greater for PD versus that in the temporal quadrant.
CONCLUSIONS


Increasing levels of induced WTR astigmatism correlated with globally diminishing VD and PD, was more symmetrical for vertical than horizontal quadrants, and was most pronounced nasally. This may be due to a high prevalence of horizontally oriented vessels nasally and the horizontal optical defocus induced by WTR astigmatism.",2020,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","['Fifteen eyes from 15 patients were imaged', 'Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a']","['Induced Astigmatism', '3\xa0× 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA']","['VD and PD', 'foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD', 'inner ring nasal quadrant', 'Spectral Domain-OCT Angiography Quantitative Metrics', 'induced WTR astigmatism']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0442137', 'cui_str': 'Parafoveal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1719796', 'cui_str': 'With-the-rule astigmatism'}]",15.0,0.026434,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","[{'ForeName': 'Jesse J', 'Initials': 'JJ', 'LastName': 'Jung', 'Affiliation': 'East Bay Retina Consultants, Inc., Oakland, California, USA; Department of Ophthalmology, Universtiy of California, San Francisco, San Francisco, California, USA. Electronic address: jung.jesse@gmail.com.'}, {'ForeName': 'Yu Qiang', 'Initials': 'YQ', 'LastName': 'Soh', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sha', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA; Silicon Valley Eyecare Optometry, Santa Clara, California, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Durbin', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Quan V', 'Initials': 'QV', 'LastName': 'Hoang', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore; Department of Ophthalmology, Edward S. Harkness Eye Institute, Columbia College of Physicians and Surgeons, New York, New York, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.005']
1967,32898990,Ward nurses-focused educational intervention improves the quality of bowel preparation in inpatients undergoing colonoscopy: A CONSORT-compliant randomized controlled trial.,"BACKGROUND


Adequate bowel preparation is essential for the detection of pathological lesions during colonoscopy. However, it has been found to be inadequate in approximately 20% to 30% of colonoscopy examinations. Educational interventions focused on health staff, such as physicians and nurses, may improve the patients' understanding of the bowel preparation instructions, and consequently, increase the quality of bowel preparation.
OBJECTIVES


To investigate whether enhanced education of ward nurses could improve the bowel preparation quality in inpatients undergoing colonoscopy.
DESIGN


This was a single-center randomized controlled study.
METHODS


A total of 190 consecutive inpatients scheduled to undergo colonoscopy from March 2019 to March 2020 were randomized to the educated (nurses with enhanced education) or control group (nurses without enhanced education). We assessed the bowel preparation quality using the Boston bowel preparation scale.
RESULTS


There were 89 patients in the educated group and 101 patients in the control group. The proportion of colonoscopies with adequate bowel preparation was 83.1% in the educated group and 69.3% in the control group. Patients' compliance with bowel preparation in the educated group was superior to that in the control group. Furthermore, significantly better sleep quality was found in the educated group. The multivariate logistic regression analysis identified the ward nurses-focused enhanced educational intervention as a risk factor for bowel preparation quality.
CONCLUSIONS


The ward nurses-focused educational intervention improved the bowel preparation quality and reduced the adverse event rates in inpatients undergoing colonoscopy.
TRIAL REGISTRATION


This study was registered in the Chinese Clinical Trial Registry under number ChiCTR2000030366.",2020,"The ward nurses-focused educational intervention improved the bowel preparation quality and reduced the adverse event rates in inpatients undergoing colonoscopy.
","['190 consecutive inpatients scheduled to undergo colonoscopy from March 2019 to March 2020', 'inpatients undergoing colonoscopy', '89 patients in the educated group and 101 patients in the control group']","['educated (nurses with enhanced education) or control group (nurses without enhanced education', 'educational intervention', 'Educational interventions']","['adverse event rates', 'quality of bowel preparation', 'proportion of colonoscopies with adequate bowel preparation', 'bowel preparation quality', 'sleep quality']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",190.0,0.0757321,"The ward nurses-focused educational intervention improved the bowel preparation quality and reduced the adverse event rates in inpatients undergoing colonoscopy.
","[{'ForeName': 'Aihong', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery.'}, {'ForeName': 'Shuhong', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Department of Gastrointestinal Surgery.'}, {'ForeName': 'Huashe', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery.'}, {'ForeName': 'Yijia', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Gastrointestinal Surgery.'}, {'ForeName': 'Junkui', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Gastrointestinal Endoscopy, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Fu', 'Affiliation': 'Department of Gastrointestinal Endoscopy, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou.'}, {'ForeName': 'Qining', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Gastrointestinal Endoscopy, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Endoscopy, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Endoscopy, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou.'}, {'ForeName': 'Honglei', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Gastrointestinal Endoscopy Center, The Eighth Affiliated Hospital, Sun Yat-sen University, Shenzhen, Guangdong, P.R. China.'}]",Medicine,['10.1097/MD.0000000000020976']
1968,32898998,Managing job stress in teachers of children with autism: A rational emotive occupational health coaching control trial.,"BACKGROUND/OBJECTIVE


Teaching has been found to be 1 of the most stressful occupations worldwide. Stress associated with teaching is more critical among teachers teaching children with special needs in general and those with autism specifically, partly due to the heterogeneous nature of the disorders. The purpose of this study was to investigate the effectiveness of Rational Emotive Occupational Health Coaching (REOHC) in minimizing job stress in teachers of children with autism (CWA).
METHODS


A group-randomized waitlist control-trial design was adopted. A sample of 87 teachers of CWA who participated in the study was randomized into the immediate intervention group (IIG) and waitlist group (WLG). Participants were evaluated on 3 occasions: pretest, post-test and follow-up. Three instruments (Occupational Stress Index, Perceived Occupational Stress Scale and Stress Symptom Scale) were used to measure dimensions of job stress. After the pretest exercise, the IIG participated in a 2-hour REOHC programme weekly for a period of 12 weeks. Post- and follow-up evaluations were conducted respectively at 2 weeks and 3 months after the REOHC programme. Those in WLG were exposed to the REOHC after the follow-up assessment. Data collected were analysed using t-test statistics, repeated measures analysis of variance and bar charts.
RESULTS


Results revealed that the perceived stress and stress symptoms of the REOHC group reduced significantly over WLG at post-test, and follow-up assessments. Changes in the occupational stress index scores across pre-, post- and follow-up measurements were minimal and could not account for a significant difference between the IIG and WLG.
CONCLUSION


It was concluded that REOHC is effective in reducing subjective feelings and physiological symptoms of job stress, even when the objective stressors remain constant among teachers of CWA and other employees who work in stressful occupational environments.",2020,"Changes in the occupational stress index scores across pre-, post- and follow-up measurements were minimal and could not account for a significant difference between the IIG and WLG.
","['A sample of 87 teachers of CWA who participated in the study', 'teachers of children with autism', 'teachers of children with autism (CWA']","['Rational Emotive Occupational Health Coaching (REOHC', 'REOHC', 'immediate intervention group (IIG) and waitlist group (WLG']","['perceived stress and stress symptoms', 'occupational stress index scores', 'instruments (Occupational Stress Index, Perceived Occupational Stress Scale and Stress Symptom Scale', 'subjective feelings and physiological symptoms of job stress']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",87.0,0.0285419,"Changes in the occupational stress index scores across pre-, post- and follow-up measurements were minimal and could not account for a significant difference between the IIG and WLG.
","[{'ForeName': 'Francisca N', 'Initials': 'FN', 'LastName': 'Ogba', 'Affiliation': 'Department of Educational Foundations, Alex Ekwueme University, Ndufu-Alike, Ebonyi State Nigeria.'}, {'ForeName': 'Charity N', 'Initials': 'CN', 'LastName': 'Onyishi', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Victor-Aigbodion', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}, {'ForeName': 'Ifeanyichukwu M', 'Initials': 'IM', 'LastName': 'Abada', 'Affiliation': ''}, {'ForeName': 'Uchenna N', 'Initials': 'UN', 'LastName': 'Eze', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}, {'ForeName': 'Patience E', 'Initials': 'PE', 'LastName': 'Obiweluozo', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}, {'ForeName': 'Christiana N', 'Initials': 'CN', 'LastName': 'Ugodulunwa', 'Affiliation': 'Department of Educational Foundations, Alex Ekwueme University, Ndufu-Alike, Ebonyi State Nigeria.'}, {'ForeName': 'Ntasiobi C N', 'Initials': 'NCN', 'LastName': 'Igu', 'Affiliation': 'Department of Educational Foundations, Alex Ekwueme University, Ndufu-Alike, Ebonyi State Nigeria.'}, {'ForeName': 'Cornelius O', 'Initials': 'CO', 'LastName': 'Okorie', 'Affiliation': 'Department of Educational Foundations, Alex Ekwueme University, Ndufu-Alike, Ebonyi State Nigeria.'}, {'ForeName': 'JeanFrance C', 'Initials': 'JC', 'LastName': 'Onu', 'Affiliation': 'School of General Studies, University of Nigeria Nsukka.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Eze', 'Affiliation': 'Department of Educational Foundations, Alex Ekwueme University, Ndufu-Alike, Ebonyi State Nigeria.'}, {'ForeName': 'Emmanuel O', 'Initials': 'EO', 'LastName': 'Ezeani', 'Affiliation': 'Department of Political Science.'}, {'ForeName': 'Elizabeth N', 'Initials': 'EN', 'LastName': 'Ebizie', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}, {'ForeName': 'Alexandra O', 'Initials': 'AO', 'LastName': 'Onwu', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}]",Medicine,['10.1097/MD.0000000000021651']
1969,32899001,Dexmedetomidine for early postoperative cognitive dysfunction after video-assisted thoracoscopic lobectomy in elderly male patients with lung cancer.,"This retrospective study explored the efficacy and safety of dexmedetomidine in treating early postoperative cognitive dysfunction (EPPNCD) after video-assisted thoracoscopic lobectomy (VATL) in elderly male patients with lung cancer (LC).This study included a total of 80 elderly male patients with LC who received VATL. All of them were equally assigned to a treatment group and a control group, with 40 patients each group. The primary outcome included cognitive dysfunction, as evaluated by mini-mental state examination scale. The secondary outcomes consisted of incidence of EPPNCD, lung function (as measured by forced vital capacity, forced expiratory volume in 1 second, peak expiratory flow, and maximal voluntary ventilation), and adverse events. All outcome data were analyzed before and 3 days after surgery.After surgery, all patients in the treatment group exerted better efficacy in mini-mental state examination scale (P < .01) and incidence of EPPNCD (P = .03), than patients in the control group. However, no significant differences were detected in forced vital capacity (P = .65), forced expiratory volume in 1 second (P = .50), peak expiratory flow (P = .73), and maximal voluntary ventilation (P = .27) between 2 groups. In addition, there is similar safety profile between 2 groups.The findings of this study showed that dexmedetomidine may benefit EPPNCD after VATL in elderly male patients with LC. Future studies are needed to warrant the present conclusions.",2020,"However, no significant differences were detected in forced vital capacity (P = .65), forced expiratory volume in 1 second (P = .50), peak expiratory flow (P = .73), and maximal voluntary ventilation (P = .27) between 2 groups.","['elderly male patients with lung cancer', 'elderly male patients with lung cancer (LC).This study included a total of 80 elderly male patients with LC who received', 'elderly male patients with LC']","['video-assisted thoracoscopic lobectomy (VATL', 'VATL', 'Dexmedetomidine', 'video-assisted thoracoscopic lobectomy', 'dexmedetomidine']","['maximal voluntary ventilation', 'cognitive dysfunction, as evaluated by mini-mental state examination scale', 'efficacy and safety', 'incidence of EPPNCD, lung function (as measured by forced vital capacity, forced expiratory volume in 1 second, peak expiratory flow, and maximal voluntary ventilation), and adverse events', 'forced expiratory volume', 'forced vital capacity', 'peak expiratory flow', 'efficacy in mini-mental state examination scale', 'incidence of EPPNCD']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0024967', 'cui_str': 'Maximum voluntary ventilation'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",80.0,0.0732969,"However, no significant differences were detected in forced vital capacity (P = .65), forced expiratory volume in 1 second (P = .50), peak expiratory flow (P = .73), and maximal voluntary ventilation (P = .27) between 2 groups.","[{'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, Chinese PLA General Hospital, Beijing.'}, {'ForeName': 'Xue-Jiang', 'Initials': 'XJ', 'LastName': 'Du', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Ya-Juan', 'Initials': 'YJ', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Mi', 'Affiliation': 'Department of Anesthesiology, Chinese PLA General Hospital, Beijing.'}]",Medicine,['10.1097/MD.0000000000021691']
1970,32899015,A randomized controlled trial for measuring effects on cognitive functions of adding ketamine to propofol during sedation for colonoscopy.,"BACKGROUND


The purpose of this study was to evaluate the effects of adding ketamine to propofol on cognitive functions in patients undergoing sedation for colonoscopy.
METHODS


In this randomized, double-blinded, and controlled study, 200 patients were randomly allocated to ketamine/propofol admixture group (Group KP, n = 100), and propofol group (Group P, n = 100). Patients in Group KP received 0.25 mg/kg of ketamine and 0.5 mg/kg of propofol. Patients in Group P received 0.5 mg/kg propofol. Cognitive functions were measured using CogState battery before and after the colonoscopy procedure. Ninety five patients in Group KP and 92 patients in Group P had completed the CogStates tests and were included in the data analysis.
RESULTS


Compared with before procedure baseline, the performance on detection and identification tasks were significantly impaired after the procedure in both Group KP (P = .004, P = .001) and Group P patients (P = .005, P < .001). However, one-card learning accuracy and One-back memory was only impaired in Group KP patients (P = .006, P = .040) after the endoscopy but left intact in Group P patients. Group KP patients showed more severe impairment in one-card learning accuracy compared with Group P patients (P = .044). Group KP patients have better 5 minutes MAP (P = .005) and were also less likely to suffer from complications such as respiratory depression (P = .023) and hypotension (P = .015). OAA/S scores, BIS, MAP, complications, recovery times, and endoscopist and patient satisfaction were similar between the 2 groups.
CONCLUSION


Although adding ketamine to propofol for sedation in colonoscopy provided fewer complications such as respiratory depression and hypotension, it also causes more impairment in cognitive functions.",2020,Group KP patients showed more severe impairment in one-card learning accuracy compared with Group P patients (P = .044).,"['patients undergoing sedation for colonoscopy', '200 patients']","['propofol', 'ketamine and 0.5\u200amg/kg of propofol', 'ketamine', 'ketamine/propofol admixture', 'ketamine to propofol']","['hypotension', 'severe impairment', 'cognitive functions', 'performance on detection and identification tasks', 'OAA/S scores, BIS, MAP, complications, recovery times, and endoscopist and patient satisfaction', 'Cognitive functions', 'respiratory depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}]",200.0,0.0832811,Group KP patients showed more severe impairment in one-card learning accuracy compared with Group P patients (P = .044).,"[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': ""Department of Anesthesiology, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang, Lianyungang.""}, {'ForeName': 'Hengfei', 'Initials': 'H', 'LastName': 'Luan', 'Affiliation': ""Department of Anesthesiology, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang, Lianyungang.""}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhu', 'Affiliation': ""Department of Anesthesiology, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang, Lianyungang.""}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathology, Basic Medical Sciences of Nanjing Medical University.'}, {'ForeName': 'Hongguang', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': 'Department of Anesthesiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}]",Medicine,['10.1097/MD.0000000000021859']
1971,32901996,Prolonging the duration of cooling does not enhance recovery following a marathon.,"Runners commonly utilize cryotherapy as part of their recovery strategy. Cryotherapy has been ineffective in mitigating signs and symptoms of muscle damage following marathon running and is limited by its duration of application. Phase change material (PCM) packs can prolong the duration of cooling. This study aimed to test the efficacy of prolonging the duration of cooling using PCM on perceptual recovery, neuromuscular function, and blood markers following a marathon run. Thirty participants completed a marathon run and were randomized to receive three hours of 15°C PCM treatment covering the quadriceps or recover without an intervention (control). Quadriceps soreness, strength, countermovement jump (CMJ) height, creatine kinase (CK), and high sensitivity C-reactive protein (hsCRP) were recorded at baseline, 24, 48, and 72 hours after the marathon. Following the marathon, strength decreased in both groups (P < .0001), with no difference between groups. Compared to baseline, strength was reduced 24 (P = .004) and 48 hours after the marathon (P = .008) in the control group, but only 24 hours (P = .028) in the PCM group. Soreness increased (P < .0001) and CMJ height decreased (P < .0001) in both groups, with no difference between groups. Compared to baseline, CMJ height was not reduced on any days in the PCM group but was reduced in the control group 24 (P < .0001) and 48 hours (P = .003) after the marathon. CK and hsCRP increased in both groups (P < .0001). Although the marathon run induced significant muscle damage, prolonging the duration of cooling using PCM did not accelerate the resolution of any dependent variables.",2020,"Soreness increased (P<0.0001) and CMJ height decreased (P<0.0001) in both groups, with no difference between groups.",['Thirty participants completed a marathon run'],"['15°C PCM treatment covering the quadriceps or recover without an intervention (control', 'Cryotherapy']","['marathon strength', 'CK and hsCRP', 'Soreness', 'Quadriceps soreness, strength, counter-movement jump (CMJ) height, creatine kinase (CK), and high sensitivity c-reactive protein (hsCRP', 'perceptual recovery, neuromuscular function, and blood markers', 'CMJ height']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",30.0,0.045918,"Soreness increased (P<0.0001) and CMJ height decreased (P<0.0001) in both groups, with no difference between groups.","[{'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Kwiecien', 'Affiliation': 'Nicholas Institute of Sports Medicine and Athletic Trauma, Lenox Hill Hospital, New York, NY, USA.'}, {'ForeName': 'Malachy P', 'Initials': 'MP', 'LastName': 'McHugh', 'Affiliation': 'Nicholas Institute of Sports Medicine and Athletic Trauma, Lenox Hill Hospital, New York, NY, USA.'}, {'ForeName': 'Kirsty M', 'Initials': 'KM', 'LastName': 'Hicks', 'Affiliation': 'Department of Sport, Exercise & Rehabilitation, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Keane', 'Affiliation': 'Department of Sport, Exercise & Rehabilitation, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Department of Sport, Exercise & Rehabilitation, Northumbria University, Newcastle upon Tyne, UK.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13822']
1972,32902905,Improving Adherence to Weight-Loss Medication (Liraglutide 3.0 mg) Using Mobile Phone Text Messaging and Healthcare Professional Support.,"BACKGROUND


Adherence to weight-loss medication is suboptimal, leading to poor health outcomes. Short message service (SMS) can potentially improve adherence.
METHODS


A total of 3,994 participants with overweight or obesity in Australia receiving Saxenda® (liraglutide 3.0 mg) were enrolled from September 1, 2017, to February 28, 2018, through doctors, pharmacists, or websites and were randomly assigned to receive none, three, or five SMS per week. Participants were additionally offered a face-to-face consultation with a diabetes educator or a call from a dietitian. Medication adherence was measured as whether the total scripts claimed were at least as many as the total claims expected by March 31, 2018, and was modeled adjusting for age, sex, baseline BMI, residential region, enrolment channel, the total number of SMS, and additional patient support.
RESULTS


Participants receiving five SMS (OR, 6.25; 95% CI: 4.28-9.12) had greater adherence than those receiving three SMS (OR, 3.67; 95% CI: 2.67-5.03) or zero SMS per week. The effectiveness of SMS on adherence decreased as participants received more SMS over time. Moreover, the odds of adhering to liraglutide were higher for participants enrolled with pharmacists compared with those enrolled with doctors (OR, 2.28; 95% CI: 1.82-2.86) and for participants who received a face-to-face consultation (OR, 3.10; 95% CI: 1.82-5.29) or a call (OR, 1.31; 95% CI: 1.02-1.68) compared with those who received no extra support.
CONCLUSIONS


Integration of SMS into routine clinical practice should consider not only the frequency and content of reminders but also additional patient support to achieve higher and more sustained adherence to medication and health behavior changes.",2020,"RESULTS


Participants receiving five SMS (OR, 6.25; 95% CI: 4.28-9.12) had greater adherence than those receiving three SMS (OR, 3.67; 95% CI: 2.67-5.03) or zero SMS per week.","['3,994 participants with overweight or obesity in Australia receiving Saxenda® (liraglutide 3.0 mg) were enrolled from September 1, 2017, to February 28, 2018, through doctors, pharmacists, or websites', 'Participants were additionally offered a face-to-face consultation with a diabetes educator or a call from a dietitian']","['SMS', 'Weight-Loss Medication (Liraglutide 3.0 mg) Using Mobile Phone Text Messaging and Healthcare Professional Support', 'Short message service (SMS']","['odds of adhering to liraglutide', 'Medication adherence', 'adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C3872102', 'cui_str': 'Saxenda'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",3994.0,0.116125,"RESULTS


Participants receiving five SMS (OR, 6.25; 95% CI: 4.28-9.12) had greater adherence than those receiving three SMS (OR, 3.67; 95% CI: 2.67-5.03) or zero SMS per week.","[{'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cunich', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Fuller', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Purcell', 'Affiliation': 'Novo Nordisk Pharmaceuticals Pty. Ltd., Baulkham Hills, New South Wales, Australia.'}, {'ForeName': 'Allanah', 'Initials': 'A', 'LastName': 'Flynn', 'Affiliation': 'Novo Nordisk Pharmaceuticals Pty. Ltd., Baulkham Hills, New South Wales, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Caterson', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22930']
1973,32915093,Effect of moderate activity on liver function and serum lipid level in healthy subjects during the phase I clinical trial.,"BACKGROUND


This study aims to investigate the incidence of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and triglyceride (TG) elevation, and the relationship with the phase I unit effect, and the moderate activity in healthy subjects enrolled in Phase I clinical trials.
METHODS


The demographic, AST, ALT, TG and activity data were collected from the placebo (146 subjects) groups and tested drug (885 subjects) groups in 20 phase I trials.
RESULTS


Elevated AST, ALT and TG levels above the upper limit of normal were detected in 1.37%, 4.79% and 34.7% of subjects in the placebo group, respectively, 3.73%, 6.67% and 39.2% of subjects in the tested drug group, respectively. The incidence of elevated AST, ALT and TG increased with the extended hospital stay. However, the incidence of elevated AST and ALT, but not the elevated TG, was reduced in subjects with moderate exercise during their hospital stay. The logistic regression analysis revealed that the baseline AST and ALT level, female gender, moderate exercise and duration of hospital stay were independent risk factors for ALT elevation.
CONCLUSION


Moderate exercise during hospital stay may reduce the elevation rate of transaminases, but not TG, in subjects at phase I trials.",2020,"However, the incidence of elevated AST and ALT, but not the elevated TG, was reduced in subjects with moderate exercise during their hospital stay.","['healthy subjects enrolled in Phase I clinical trials', '146 subjects) groups and tested drug (885 subjects) groups in 20 phase I trials']","['TG', 'placebo']","['levels above the upper limit of normal', 'baseline AST and ALT level, female gender, moderate exercise and duration of hospital stay', 'incidence of elevated AST, ALT and TG', 'aspartate aminotransferase (AST), alanine aminotransferase (ALT) and triglyceride (TG) elevation', 'elevation rate of transaminases', 'demographic, AST, ALT, TG and activity data']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0282459', 'cui_str': 'Clinical Trial, Phase 1'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038577', 'cui_str': 'Drug of abuse screen'}, {'cui': 'C0920321', 'cui_str': 'Phase I Clinical Trials'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151904', 'cui_str': 'Aspartate aminotransferase increased'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0553448,"However, the incidence of elevated AST and ALT, but not the elevated TG, was reduced in subjects with moderate exercise during their hospital stay.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University , Changchun, Jilin, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University , Changchun, Jilin, China.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University , Changchun, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University , Changchun, Jilin, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University , Changchun, Jilin, China.'}]",Expert opinion on drug metabolism & toxicology,['10.1080/17425255.2020.1823369']
1974,32909954,The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable eHealth Intervention for the Management of Gestational Weight Gain in Low-Income Women: Protocol for the SmartMoms in WIC Trial.,"BACKGROUND


Less than one-third of women gain an appropriate amount of weight during pregnancy, which can influence the long-term health of both the mother and the child. Economically disadvantaged women are the most vulnerable to maternal obesity, excessive weight gain during pregnancy, and poor birth outcomes. Effective and scalable health care strategies to promote healthy weight gain during pregnancy specifically tailored for these women are lacking.
OBJECTIVE


This paper presents the design and protocol of a biphasic, community-based eHealth trial, SmartMoms in WIC, to increase the adherence to healthy gestational weight gain (GWG) recommendations in low-income mothers receiving women, infant, and children (WIC) benefits.
METHODS


Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits. The health curriculum, the format of delivery, and incentive strategies were adapted to be culturally relevant and at an appropriate level of health literacy. Phase 2 included a pragmatic randomized controlled trial across the 9 health care regions in Louisiana with the goal of enrolling 432 women. The SmartMoms in WIC intervention is an intensive 24-week behavioral intervention, which includes nutrition education and exercise strategies, and provides the technology to assist with weight management, delivered through a professionally produced website application.
RESULTS


Phase 1 of this trial was completed in July 2019, and recruitment for phase 2 began immediately thereafter. All data are anticipated to be collected by Spring 2023.
CONCLUSIONS


The SmartMoms in WIC curriculum was methodically developed using feedback from community-based peer advisory groups to create a culturally relevant, mobile behavioral intervention for mothers receiving WIC benefits. The randomized clinical trial is underway to test the effectiveness of a sustainable eHealth program on the incidence rates of appropriate GWG. SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04028843; https://clinicaltrials.gov/ct2/show/NCT04028843.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18211.",2020,"SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC.
","['Low-Income Women', '9 health care regions in Louisiana with the goal of enrolling 432 women', 'Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits']","['sustainable eHealth program', 'Pragmatic and Scalable eHealth Intervention']","['healthy weight gain', 'Gestational Weight Gain', 'healthy gestational weight gain (GWG) recommendations']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0425006', 'cui_str': 'Child benefit'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",432.0,0.16195,"SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC.
","[{'ForeName': 'Emily W', 'Initials': 'EW', 'LastName': 'Flanagan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Abby D', 'Initials': 'AD', 'LastName': 'Altazan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Natalie R', 'Initials': 'NR', 'LastName': 'Comardelle', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'L Anne', 'Initials': 'LA', 'LastName': 'Gilmore', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'St Romain', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Hardee', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Renee S', 'Initials': 'RS', 'LastName': 'Puyau', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Christy L', 'Initials': 'CL', 'LastName': 'Mayet', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'S Ariel', 'Initials': 'SA', 'LastName': 'Barlow', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Sarah Surber', 'Initials': 'SS', 'LastName': 'Bounds', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Kelsey N', 'Initials': 'KN', 'LastName': 'Olson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Betty M', 'Initials': 'BM', 'LastName': 'Kennedy', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Hsia', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}]",JMIR research protocols,['10.2196/18211']
1975,32911350,Medication adherence and rate of nicotine metabolism are associated with response to treatment with varenicline among smokers with HIV.,"INTRODUCTION


PLWHA who smoke have shown lower cessation rates within placebo-controlled randomized trials of varenicline. Adherence and rate of nicotine metabolism may be associated with quit rates in such clinical trials.
METHODS


This secondary analysis of a randomized placebo-controlled trial of varenicline for smoking among PLWHA (N = 179) examined the relationship between varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation (self-reported 7-day point prevalence abstinence, confirmed with carbon monoxide of ≤ 8 ppm, at the end of treatment; EOT).
RESULTS


Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates. In separate models, adherence (OR = 1.009, 95% CI:1.004-1.01, p < 0.001) and nicotine metabolism rate (OR = 2.04, 95% CI:1.19-3.49, p = 0.009) interacted with treatment arm to effect quit rates. The quit rate for varenicline vs. placebo was higher for both non-adherent (19% vs. 5%; χ 2 [1] = 2.80, p = 0.09) and adherent (35% vs. 15%; χ 2 [1] = 6.51, p = 0.01) participants, but the difference between treatment arms was statistically significant only for adherent participants. Likewise, among slow metabolizers (NMR < 0.31), the varenicline quit rate was not significantly higher vs. placebo (14% vs. 5%; χ 2 [1] = 1.17, p = 0.28) but, among fast metabolizers (NMR ≥ 0.31), the quit rate for varenicline was significantly higher vs. placebo (33% vs. 14%; χ 2 [1] = 4.43, p = 0.04).
CONCLUSIONS


Increasing varenicline adherence and ensuring that fast nicotine metabolizers receive varenicline may increase quit rates for PLWHA.",2020,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.",['smokers with HIV'],"['varenicline and placebo', 'varenicline', 'varenicline vs. placebo', 'varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation', 'placebo']","['nicotine metabolism rate', 'varenicline quit rate', 'quit rate for varenicline', 'quit rate', 'Medication adherence and rate of nicotine metabolism', 'faster nicotine metabolism']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1095963', 'cui_str': 'Smoking cessation therapy'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",179.0,0.482863,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.","[{'ForeName': 'Anna-Marika', 'Initials': 'AM', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Hosie Quinn', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Su Fen', 'Initials': 'SF', 'LastName': 'Lubitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Leone', 'Affiliation': 'Department of Medicine/Division of Pulmonary, Allergy, & Critical Care, University of Pennsylvania, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Department of Medicine/Division of Infectious Diseases, University of Pennsylvania, United States; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hitsman', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry and Abramson Cancer Center, University of Pennsylvania, United States. Electronic address: schnoll@pennmedicine.upenn.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106638']
1976,32912514,"Adherence to study drug in a stroke prevention trial""?>.","OBJECTIVE


Standards for reporting and analyzing adherence to medical therapy have recently improved due to international consensus efforts. If applied to clinical trial research in patients with stroke, these improvements have the potential to identify when in the sequence of trial operations participants are at risk for non-adherence and opportunities to safeguard adherence.
METHODS


We analyzed three phases of adherence according to the European Society for Patient Adherence, COMpliance, and Persistence (ESPACOMP) Medication Adherence Reporting Guideline (EMERGE) taxonomy in the Insulin Resistance Intervention after Stroke (IRIS) trial: initiation (did patient start drug), implementation (did patient take a drug holiday, defined as temporary cessation lasting ≥14 days), and persistence (did patient prematurely and permanently discontinue drug). IRIS was a randomized, placebo controlled, double-blind trial testing pioglitazone to prevent stroke or myocardial infarction in patients with a recent ischemic stroke or transient ischemic attack. Adherence was classified by self-report. Researchers used coaching algorithms to seek adherence recovery if participants went off drug.
RESULTS


During 2005-2013, 3876 participants were enrolled from 179 sites in seven countries and followed for a mean of 4.8 years. Less than 1% of participants in each group did not initiate study drug. 20% of patients assigned to pioglitazone and 17% assigned to placebo took at least one drug holiday. 36% and 30%, respectively, discontinued the study drug prematurely with or without a prior holiday. The risk for stopping the study drug (temporarily or permanently) in the first year after randomization was twice the risk in each of the subsequent four years. This was true both for patients assigned to active therapy and placebo. More participants assigned to pioglitazone, compared to placebo, took a drug holiday or permanently stopped study drug, but the difference in rates of discontinuation was only evident in year one. In years two through five, rates of discontinuation were similar in the two treatment groups. The difference in rates during year one was the result of adverse effects related to the active study drug, pioglitazone. During the remainder of the trial, the attribution of discontinuations to adverse effects potentially related to pioglitazone was reduced but still higher in those assigned to active drug. Other reasons for discontinuation were similar between treatment groups and were largely unrelated to pharmacodynamic effects of the study drug. Rates of discontinuation varied widely among research sites.
CONCLUSION


Patients in a drug trial for stroke prevention are at greatest risk for premature drug discontinuation early after randomization. Reasons for discontinuation change over time. Variable discontinuation rates among sites suggests that adherence can be improved by using best practices from high-performing sites.",2020,"More participants assigned to pioglitazone, compared to placebo, took a drug holiday or permanently stopped study drug, but the difference in rates of discontinuation was only evident in year one.","['participants went off drug', 'During 2005-2013, 3876 participants were enrolled from 179 sites in seven countries and followed for a mean of 4.8 years', 'patients with a recent ischemic stroke or transient ischemic attack', 'patients with stroke']","['placebo', 'pioglitazone']","['stroke or myocardial infarction', 'rates of discontinuation']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",3876.0,0.437434,"More participants assigned to pioglitazone, compared to placebo, took a drug holiday or permanently stopped study drug, but the difference in rates of discontinuation was only evident in year one.","[{'ForeName': 'Akshatha', 'Initials': 'A', 'LastName': 'Kiran', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States. Electronic address: Akshatha.kiran@yale.edu.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Viscoli', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States. Electronic address: catherine.viscoli@yale.edu.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Furie', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI, United States. Electronic address: kfurie@lifespan.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gorman', 'Affiliation': 'Maine Medical Center, Portland, ME, United States.'}, {'ForeName': 'Walter N', 'Initials': 'WN', 'LastName': 'Kernan', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States. Electronic address: walter.kernan@yale.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105048']
1977,32907282,[The effect of booster dose vaccination 21- to 32-years after primary vaccination with hepatitis B vaccine in the population born from 1986 to 1996 in Zhengding County of Hebei Province].,"Objective:  Aanalysis the effect of booster one dose of hepatitis B vaccine after 21-32 years of primary immunization in Zhengding Country of Hebei Province.  Methods:  A total of 322 participants who were born between 1986 and 1996, received a full course of primary vaccination with plasma-derived hepatitis B vaccine (HepB), had no experience with booster vaccination, were HBsAg, anti-HBcnegative, had anti-HBs<10 mIU/ml, completed the booster and had laboratory results were enrolled between August 2017 to February 2018. A simple random method was uesd to randomly assigned 322 subjects to two groups, receiving a booster dose of HepB derived from either Saccharomyces cerevisiae ［HepB (SC), (151 cases)］ or Chinese hamster ovary-derived HepB ［HepB (CHO), (171 cases)］, the dose was 20 μg. Blood samples were collected 30 days after boosting and quantitatively tested for the geometric mean concentration (GMC) of anti-HBs to assess immunological effect. The related influencing factors of GMC and seroconversion rates of anti-HBs were analyzed by multiple linear regression and multivariate logistic regression models.  Results:  The 266 subjects (82.61%) had anti-HBs≥ 10 mIU/ml, and GMC was (131.63±12.94) mIU/ml.The seroconversion rates of anti-HBs in the anti-HBs<2.5 mIU/ml group and 2.5-10 mIU/ml group were 74.54% (161 cases) and 99.06% (105 cases), respectively ( P <0.001).The seroconversion rates of anti-HBs after one dose of HepB (CHO) was higher than that of one dose of HepB (SC), the seroconversion rates were 87.13% (149 cases) and 77.48% (117 cases), respectively ( P =0.023). Participants boostered with HepB (CHO) was the factor influencing the effect of strengthening immunization compared with boostered with HepB (SC), and  OR  (95% CI ) was 1.91 (1.02-3.56) ( P =0.042).Compared with anti-HBs<2.5 mIU/ml, prebooster anti-HBs was between 2.5 mIU/ml and 10 mIU/ml was the related factor of seroconversion rates of anti-HBs after booster immunization, and  OR  (95% CI ) was 36.15 (4.91-266.02) ( P <0.001).  Conclusion:  Participants boostered withone dose of HepB had a good immune response. Pre-booster anti-HBs concentration and a variety of vaccine were related factors of immune response.",2020,"The seroconversion rates of anti-HBs in the anti-HBs<2.5 mIU/ml group and 2.5-10 mIU/ml group were 74.54% (161 cases) and 99.06% (105 cases), respectively ( P <0.001).The seroconversion rates of anti-HBs after one dose of HepB (CHO) was higher than that of one dose of HepB (SC), the seroconversion rates were 87.13% (149 cases) and 77.48% (117 cases), respectively ( P =0.023).","['after 21-32 years of primary immunization in Zhengding Country of Hebei Province', 'population born from 1986 to 1996 in Zhengding County of Hebei Province', '322 participants who were born between 1986 and 1996, received a full course of primary vaccination with plasma-derived hepatitis B vaccine (HepB), had no experience with booster vaccination, were HBsAg, anti-HBcnegative, had anti-HBs<10 mIU/ml, completed the booster and had laboratory results were enrolled between August 2017 to February 2018', '266 subjects (82.61%) had anti-HBs≥ 10 mIU/ml, and GMC was (131.63±12.94) mIU/ml']","['hepatitis B vaccine', 'HepB', 'booster dose of HepB derived from either Saccharomyces cerevisiae ［HepB (SC), (151 cases)］ or Chinese hamster ovary-derived HepB ［HepB (CHO', 'booster dose vaccination 21- to 32-years after primary vaccination with hepatitis B vaccine']","['seroconversion rates', 'GMC and seroconversion rates of anti-HBs', 'seroconversion rates of anti-HBs']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1328526', 'cui_str': 'Primary immunization'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0061073', 'cui_str': 'gamma-hydroxy-gamma-ethyl-gamma-phenylbutyramide'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0018555', 'cui_str': 'Chinese Hamster'}, {'cui': 'C0029939', 'cui_str': 'Ovarian structure'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0201478', 'cui_str': 'Hepatitis B surface antibody measurement'}]",322.0,0.0969828,"The seroconversion rates of anti-HBs in the anti-HBs<2.5 mIU/ml group and 2.5-10 mIU/ml group were 74.54% (161 cases) and 99.06% (105 cases), respectively ( P <0.001).The seroconversion rates of anti-HBs after one dose of HepB (CHO) was higher than that of one dose of HepB (SC), the seroconversion rates were 87.13% (149 cases) and 77.48% (117 cases), respectively ( P =0.023).","[{'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Zhang', 'Affiliation': 'Zhengding County Center for Disease Control and Prevention，Shijiazhuang 050800, China.'}, {'ForeName': 'Z W', 'Initials': 'ZW', 'LastName': 'Wu', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': 'Zhengding County Center for Disease Control and Prevention，Shijiazhuang 050800, China.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Li', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Zhou', 'Affiliation': 'Zhengding County Center for Disease Control and Prevention，Shijiazhuang 050800, China.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Han', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}, {'ForeName': 'Z Y', 'Initials': 'ZY', 'LastName': 'Hao', 'Affiliation': 'Zhengding County Center for Disease Control and Prevention，Shijiazhuang 050800, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chu', 'Affiliation': 'Zhengding County Center for Disease Control and Prevention，Shijiazhuang 050800, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Ma', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Zhao', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}]",Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine],['10.3760/cma.j.cn112150-20200509-00710']
1978,32907283,[ A phase  Ⅲ  clinical trial study on the safety and immunogenicity of ACYW135 group meningococcal conjugate vaccine inoculated in 3 month old infants ].,"Objective:  The aim of this study was to evaluate the safety and immunogenicity of the first domestic ACYW135 meningococcal conjugate vaccine and a control vaccine named AC group meningococcal conjugate vaccine for 3 months (90-119 days) infants.  Methods:  From February 2017 to June 2018, a randomized, blinded, and similar vaccine-controlled clinical trial design was adopted at the Henan Vaccine Clinical Research Base. The subjects were 3 months old healthy infants, a total of 720, based on a 1∶1 ratio. The random allocation table for entry was randomly assigned to the experimental group and the control group. According to the 3, 4, and 5 month-old vaccination procedures, the subjects were vaccinated with test vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine), of which 720 were given the first dose, 696 were given the second dose (test group: 346; control group: 350), and 692 were given the third dose (test group: 344; Control group: 348).  Results:  The overall adverse reaction rate of the test vaccine was 21.90% (230 cases), which was lower than the 32.04% (339 cases) of the control vaccine ( P <0.001). The incidence of systemic adverse reactions was 19.52% (205 cases), which was lower than that of the control vaccine (27.69%) (293 cases) ( P <0.001). The local adverse reaction rate was 3.04% (32 cases), which was lower than the control group (7.84%) (83 cases) ( P <0.001). The graded adverse reaction test vaccine was 0.57% (6 cases), which was lower than the control group of 2.36% (25 cases) ( P <0.001). The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) ( P >0.05). Group Y and W135 was 88.17% (298 cases), 99.41% (336 cases), respectively. The GMT results showed that the test vaccine group A was 56.24, the control vaccine was 57.43 ( P >0.05); the group C test vaccine (43.53) was higher than the control group (27.28) ( P <0.001). The group Y and W135 are 89.22 and 140.66, respectively. Among them, the proportion of the group C GMT antibody ≥ 1∶128 for test vaccine (31.07%, 105 cases) was higher than the control vaccine (16.22%, 55 cases) ( P <0.001).  Conclusion:  ACYW135 group meningococcal conjugate vaccine has more safety and immunogenicity after application to 3 month old infants.",2020,"The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) ( P >0.05).","['3 month old infants ', '3 months (90-119 days) infants', 'subjects were 3 months old healthy infants, a total of 720, based on a 1∶1 ratio']","['control vaccine', 'meningococcal conjugate vaccine', 'vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine', 'ACYW135 group meningococcal conjugate vaccine']","['positive conversion rate of anti-bacterial serum antibodies', 'incidence of systemic adverse reactions', 'local adverse reaction rate', 'graded adverse reaction test vaccine', 'safety and immunogenicity', 'overall adverse reaction rate']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0620904,"The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) ( P >0.05).","[{'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Xie', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}, {'ForeName': 'D Y', 'Initials': 'DY', 'LastName': 'Zhao', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Huang', 'Affiliation': 'CanSino Biologics Inc., Tianjin 300457, China.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Gou', 'Affiliation': 'CanSino Biologics Inc., Tianjin 300457, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou 450001, China.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Huang', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}, {'ForeName': 'Y X', 'Initials': 'YX', 'LastName': 'Wang', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'CanSino Biologics Inc., Tianjin 300457, China.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Xu', 'Affiliation': 'CanSino Biologics Inc., Tianjin 300457, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'CanSino Biologics Inc., Tianjin 300457, China.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Xia', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}]",Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine],['10.3760/cma.j.cn112150-20200520-00758']
1979,32908483,Mindfulness Training Enhances Endurance Performance and Executive Functions in Athletes: An Event-Related Potential Study.,"Mindfulness interventions have been linked to improved sport performance and executive functions; however, few studies have explored the effects of mindfulness on sport performance and executive functions simultaneously. This study sought to examine whether a mindfulness training program would affect both the endurance performance and executive functions of athletes. In addition, event-related potentials (ERPs) associated with the Stroop task were assessed to investigate the potential electrophysiological activation associated with the mindfulness training. Applying a quasiexperimental design, forty-six university athletes were recruited and assigned into a five-week mindfulness training program or a waiting list control group. For each participant, the mindfulness level, endurance performance assessed by a graded exercise test, executive functions assessed via Stroop task, and N2 component of ERPs were measured prior to and following the 5-week intervention. After adjusting for the preintervention scores as a covariate, it was found that the postintervention mindfulness level, exhaustion time, and Stroop task accuracy scores, regardless of task condition, of the mindfulness group were higher than those of the control group. The mindfulness group also exhibited a smaller N2 amplitude than the control group. These results suggest that the five-week mindfulness program can enhance the mindfulness level, endurance performance, and multiple cognitive functions, including executive functions, of university athletes. Mindfulness training may also reduce conflict monitoring in neural processes.",2020,The mindfulness group also exhibited a smaller N2 amplitude than the control group.,"['Athletes', 'forty-six university athletes', 'athletes']","['mindfulness training program or a waiting list control group', 'Mindfulness training', 'Mindfulness Training', 'mindfulness training program']","['mindfulness level, endurance performance assessed by a graded exercise test, executive functions assessed via Stroop task, and N2 component of ERPs', 'mindfulness level, endurance performance, and multiple cognitive functions, including executive functions, of university athletes', 'Endurance Performance and Executive Functions', 'postintervention mindfulness level, exhaustion time, and Stroop task accuracy scores, regardless of task condition']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",46.0,0.00975068,The mindfulness group also exhibited a smaller N2 amplitude than the control group.,"[{'ForeName': 'Jui-Ti', 'Initials': 'JT', 'LastName': 'Nien', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, Taoyuan City, Taiwan.'}, {'ForeName': 'Chih-Han', 'Initials': 'CH', 'LastName': 'Wu', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, Taoyuan City, Taiwan.'}, {'ForeName': 'Kao-Teng', 'Initials': 'KT', 'LastName': 'Yang', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, Taoyuan City, Taiwan.'}, {'ForeName': 'Yu-Min', 'Initials': 'YM', 'LastName': 'Cho', 'Affiliation': 'Center for East-West Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Chien-Heng', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Kai', 'Initials': 'YK', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}]",Neural plasticity,['10.1155/2020/8213710']
1980,32909467,Exercise Adherence and Effect of Self-Regulatory Behavior Change Techniques in Patients Undergoing Curative Cancer Treatment: Secondary Analysis from the Phys-Can Randomized Controlled Trial.,"INTRODUCTION


Adherence to exercise interventions in patients with cancer is often poorly described. Further, it is unclear if self-regulatory behavior change techniques (BCTs) can improve exercise adherence in cancer populations. We aimed to (1) describe exercise adherence in terms of frequency, intensity, time, type (FITT-principles) and dropouts, and (2) determine the effect of specific self-regulatory BCTs on exercise adherence in patients participating in an exercise intervention during curative cancer treatment.
METHODS


This study was a secondary analysis using data from a Swedish multicentre RCT. In a 2×2 factorial design, 577 participants recently diagnosed with curable breast, colorectal or prostate cancer were randomized to 6 months of high (HI) or low-to-moderate intensity (LMI) exercise,  with  or  without  self-regulatory BCTs (e.g., goal-setting and self-monitoring). The exercise program included supervised group-based resistance training and home-based endurance training. Exercise adherence (performed training/prescribed training) was assessed using attendance records, training logs and heart rate monitors, and is presented descriptively. Linear regression and logistic regression were used to assess the effect of self-regulatory BCTs on each FITT-principle and dropout rates, according to intention-to-treat.
RESULTS


For resistance training (groups  with  vs  without  self-regulatory BCTs), participants attended on average 52% vs 53% of prescribed sessions, performed 79% vs 76% of prescribed intensity, and 80% vs 77% of prescribed time. They adhered to exercise type in 71% vs 68% of attended sessions. For endurance training (groups  with  vs  without  self-regulatory BCTs), participants performed on average 47% vs 51% of prescribed sessions, 57% vs 62% of prescribed intensity, and 71% vs 72% of prescribed time. They adhered to exercise type in 79% vs 78% of performed sessions. Dropout rates (groups  with  vs  without  self-regulatory BCTs) were 29% vs 28%. The regression analysis revealed no effect of the self-regulatory BCTs on exercise adherence.
CONCLUSION


An exercise adherence rate ≥50% for each FITT-principle and dropout rates at ~30% can be expected among patients taking part in long-term exercise interventions, combining resistance and endurance training during curative cancer treatment. Our results indicate that self-regulatory BCTs do not improve exercise adherence in interventions that provide evidence-based support to all participants (e.g., supervised group sessions).
TRIAL REGISTRATION


NCT02473003.",2020,"The regression analysis revealed no effect of the self-regulatory BCTs on exercise adherence.
","['Patients Undergoing Curative Cancer Treatment', '577 participants recently diagnosed with curable breast, colorectal or prostate cancer', 'patients participating in an exercise intervention during curative cancer treatment', 'patients with cancer']","['resistance training', 'high (HI) or low-to-moderate intensity (LMI) exercise,  with  or  without  self-regulatory BCTs (e.g., goal-setting and self-monitoring', 'specific self-regulatory BCTs', 'endurance training (groups  with  vs  without  self-regulatory BCTs', 'Self-Regulatory Behavior Change Techniques', 'exercise program included supervised group-based resistance training and home-based endurance training']","['Dropout rates', 'exercise adherence', 'Exercise adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",577.0,0.0544387,"The regression analysis revealed no effect of the self-regulatory BCTs on exercise adherence.
","[{'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Mazzoni', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Brooke', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nordin', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Demmelmaier', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}]",Integrative cancer therapies,['10.1177/1534735420946834']
1981,32911037,Chronotherapeutic efficacy of suvorexant on sleep quality and metabolic parameters in patients with type 2 diabetes and insomnia.,"AIMS


This study aimed to assess the chronotherapeutic efficacy of suvorexant on subjective sleep parameters and metabolic parameters in patients with type 2 diabetes and insomnia.
METHODS


Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14 ± 2 weeks. The following parameters were assessed before and after the treatment: sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake.
RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p < 0.05), but did not change HbA1c, CGM parameters, or body weight. Correlation analysis revealed that changes in sSE were associated with those in HbA1c and body weight (r = -0.61 and r = -0.66, respectively; both p < 0.05).
CONCLUSIONS


Suvorexant significantly improved sleep quality and obesity-associated parameters in patients with type 2 diabetes in 14 weeks. Improvements in sleep quality were associated with improvements in glycemic control. Sleep disorder treatment using suvorexant may provide metabolic benefits for patients with type 2 diabetes.",2020,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","['patients with type 2 diabetes in 14 weeks', 'Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14±2 weeks', 'patients with type 2 diabetes and insomnia', 'patients with type 2 diabetes']",['suvorexant'],"['sleep quality and obesity-associated parameters', 'glycemic control', 'sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake', 'HbA1c and body weight', 'change HbA1c, CGM parameters, or body weight', 'Chronotherapeutic efficacy', 'sleep quality and metabolic parameters', 'subjective sleep parameters and metabolic parameters', 'sleep quality', 'sSE, abdominal circumference, and sucrose intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C3179535', 'cui_str': 'suvorexant'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0556137', 'cui_str': 'Sucrose intake'}]",13.0,0.026373,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","[{'ForeName': 'Fukumi', 'Initials': 'F', 'LastName': 'Yoshikawa', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Fumika', 'Initials': 'F', 'LastName': 'Shigiyama', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Yasuyo', 'Initials': 'Y', 'LastName': 'Ando', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Miyagi', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Uchino', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kumashiro', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan. Electronic address: naoki.kumashiro@med.toho-u.ac.jp.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108412']
1982,32911132,A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial.,"BACKGROUND


Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs.
METHOD


This single-site, randomized controlled pilot trial enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months. Participants (N = 80) were randomized to PRSS (n = 40) or Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone. Outcome measures obtained at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization included verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS.
RESULTS


Through 12-month follow-up, 32.5 % of PRSS, compared to 17.5 % of Control participants enrolled in MOUD (X 2  = 2.4, p = 0.12; odds ratio = 2.27 (0.79-6.49)). PRSS participants were significantly less likely to have experienced an OOD through 12-month follow-up (12.5 % of PRSS participants, 32.5 % of Control, p = 0.03). No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days. Based on self-report, PRSS had good acceptability for both the interventionists and participants.
CONCLUSIONS


The results suggest that further development and testing of this PRSS telephone intervention to encourage MOUD enrollment and reduce OOD may be warranted.",2020,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"['individuals with opioid use disorder', 'Participants (N = 80', 'individuals surviving an opioid overdose', 'enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months']","['PRSS', 'PRSS telephone intervention', 'Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone', 'Peer recovery support services (PRSS', 'telephone-delivered PRSS intervention', 'telephone-delivered peer intervention']","['verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0743300', 'cui_str': 'Urine drug screen positive'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",80.0,0.0748964,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108270']
1983,32911138,"Short-term oral corticosteroids for initial treatment of moderate-to-severe persistent asthma: A double-blind, randomized, placebo-controlled trial.","BACKGROUND AND PURPOSE


The purpose of this study was to investigate that on the basis of ICS-LABA treatment, whether or not adding on short course of oral corticosteroid could increase the rate of asthma control.
METHODOLOGY


This was a double blind, randomized controlled study. Patients with moderate to severe persistent asthma who are maintenance treatment naïve were recruited from the out-patients clinic. All patients included in the study received ICS-LABA as initial treatment. Two weeks oral corticosteroid or placebo were added on at the beginning of treatment. All the subjects were followed-up by daily measurement of PEF and asthma diary for 12 week and spirometry at 4 weeks and 12 weeks.
RESULTS


13 cases were randomized to Corticosteroid group (M/F: 9/4, age: 45.0 ± 5.0 yrs), 11 to Placebo group (M/F: 4/7, age: 35.7 ± 9.6yrs). After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05). However, there were no significant difference between two groups in the improvement of ACT、ACQ、AQLQ、FEV1、FEV1% (all P > 0.05). After 4 weeks of treatment, total control was achieved in 3 (30.8%) in corticosteroid group and 2 (18.2%) in placebo group; Partial control was achieved in 7 (61.5%)in corticosteroid group and in 7 (63.6%) in placebo group. There was no significant difference in control rates between two groups (X 2  = 0.919, P = 0.632). Similar findings were observed after 12 weeks of treatment.
CONCLUSION


In maintenance treatment naïve moderate to severe persistent asthma, ICS-LABA therapy was adequate initial treatment for achieving asthma control in majority of the patients. Add on short course of oral corticosteroid provided no significant clinical benefit.",2020,"After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05).","['moderate-to-severe persistent asthma', '13 cases', 'Patients with moderate to severe persistent asthma who are maintenance treatment naïve were recruited from the out-patients clinic']","['Short-term oral corticosteroids', 'corticosteroid or placebo', 'placebo', 'ICS-LABA', 'Corticosteroid', 'Placebo']","['total control', 'control rates', 'rate of asthma control']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",13.0,0.251154,"After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05).","[{'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}, {'ForeName': 'Dongming', 'Initials': 'D', 'LastName': 'Hua', 'Affiliation': 'Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (National Clinical Research Center for Respiratory Diseases), Guangzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liao', 'Affiliation': 'Guangzhou Overseas Chinese Hospital, China.'}, {'ForeName': 'Rongchang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (National Clinical Research Center for Respiratory Diseases), Guangzhou, China. Electronic address: chenrc@vip.163.com.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106126']
1984,32911210,Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students: A structural equation modeling approach.,"BACKGROUND


The purpose of this study is to evaluate the effectiveness of the Mindfulness-based Stress Reduction program applied to a sample of Turkish nursing students.
METHOD


The study was designed as a randomized controlled trial. Program sessions of 90-95 minutes were given twice a week for 12 weeks. The data were collected using the Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale.
RESULTS


A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions. On the Mindfulness Scale, a statistically significant difference was found between the mean pre-test and post-test scores obtained by the experiment and control groups.
CONCLUSION


The results derived from this study suggest that the mindfulness-based stress reduction program is effective in reducing the stress experienced by students during nursing education, increasing their mindfulness, strengthening their coping mechanisms for stress, increasing their use of self-confident and optimistic approaches, and decreasing their use of the helpless approach.",2020,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"['Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students', 'Turkish nursing students']","['mindfulness-based stress reduction program', 'Mindfulness-based Stress Reduction program']","['Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale', 'Nursing Education Stress Scale']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]",95.0,0.0107001,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yıldırım Şişman', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: nuriyeyildirim@duzce.edu.tr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karaca', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: ayselkaraca@duzce.edu.tr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cangür', 'Affiliation': 'DuzceUniversity, Faculty of Medicine, Department of Biostatistics and Medical Informatics, Duzce, Turkey. Electronic address: sengulcangur@duzce.edu.tr.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102880']
1985,32912308,Using qualitative research to explore intervention mechanisms: findings from the trial of the Learning Together whole-school health intervention.,"BACKGROUND


This study reports on qualitative research conducted within a randomised controlled trial to explore possible intervention mechanisms. It focuses on the 'Learning Together' whole-school intervention delivered in secondary schools in England from 2014 to 2017 aiming to prevent bullying and aggression and improve student health. Intervention schools received staff training in restorative practice, a social and emotional learning curriculum, and an external facilitator and manual to convene and run a student/staff action group tasked with coordinating the intervention, focusing this on local needs.
METHODS


Informed by realist approaches to evaluation, we analysed qualitative data to explore intervention mechanisms and how these might interact with school contexts to generate outcomes. Qualitative analysis drew on 45 interviews and 21 focus groups across three case-study schools and employed thematic content analysis to explore how intervention resources were taken up and used by local actors, how participants described the intervention mechanisms that then ensued, and how these might have generated beneficial outcomes.
RESULTS


The thematic content analysis identified three social mechanisms that recurred in participant accounts: (1) building student commitment to the school community, (2) building healthy relationships by modelling and teaching pro-social skills, and (3) de-escalating bullying and aggression and enabling re-integration within the school community.
CONCLUSIONS


Our analysis provides in-depth exploration of possible mechanisms and the contextual contingencies associated with these, allowing refinement of the initial intervention theory of change.
TRIAL REGISTRATION


ISRCTN registry 10751359 . Registered on 11 March 2014.",2020,"The thematic content analysis identified three social mechanisms that recurred in participant accounts: (1) building student commitment to the school community, (2) building healthy relationships by modelling and teaching pro-social skills, and (3) de-escalating bullying and aggression and enabling re-integration within the school community.
",[],"['staff training in restorative practice, a social and emotional learning curriculum, and an external facilitator and manual to convene and run a student/staff action group tasked with coordinating the intervention, focusing this on local needs']",[],[],"[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0582589', 'cui_str': 'Emotional learning'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]",[],,0.0292106,"The thematic content analysis identified three social mechanisms that recurred in participant accounts: (1) building student commitment to the school community, (2) building healthy relationships by modelling and teaching pro-social skills, and (3) de-escalating bullying and aggression and enabling re-integration within the school community.
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warren', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK. emily.warren@lshtm.ac.uk.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Melendez-Torres', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Viner', 'Affiliation': 'UCL Institute of Child Health, London, WC1N 1EH, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}]",Trials,['10.1186/s13063-020-04688-2']
1986,32916181,The effects of an exercise training on steroid hormones in preadolescent children - a moderator for enhanced cognition?,"OBJECTIVE


Research demonstrates a variety of cognitive benefits induced by different chronic physiological stressors (e.g. motor vs. cardiovascular exercise training) and acute exercise to affect steroid hormone secretion, the present study aims to investigate 1.) motor vs. cardiovascular exercise training and their impact on salivary Testosterone, Estradiol and Progesterone and 2.) whether alterations in steroid hormones might moderate exercise-induced cognitive benefits.
METHODS


In a randomized control trial, 71 preadolescent children (39 girls) at the age of 9-10 years were randomly assigned to a cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON) in which students were attending assisted homework. The participants attended their program three times per week, for a total of 10 weeks. Steroid hormones in the saliva, working memory performance and state-trait anxiety levels were determined before and after the intervention.
RESULTS


Statistical analysis showed no chronic changes in hormones through the interventions. Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014). Within the ME, increases of Testosterone from t 1  to t 2  were predicting higher working memory performance post-intervention (β = 0.45, R 2  = 0.16, p = 0.038).
CONCLUSION


Our findings suggest 1.) that motor-exercise-induced cognitive benefits are moderated by changes in Testosterone and 2.) that a 10-week exercise training of moderate intensity and with a motor demanding vs a cardiovascular character does not affect the chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels in preadolescent children.",2020,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","['preadolescent children', '71 preadolescent children (39 girls) at the age of 9-10 years']","['cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON', 'exercise training', 'motor vs. cardiovascular exercise training']","['salivary Testosterone, Estradiol and Progesterone and 2', 'saliva, working memory performance and state-trait anxiety levels', 'Testosterone', 'steroid hormones', 'chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",71.0,0.0658097,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","[{'ForeName': 'Davin P', 'Initials': 'DP', 'LastName': 'Akko', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany; Faculty of Humanities and Social Sciences, University of Hagen, Hagen, Germany. Electronic address: davin-patrick.akko@fernuni-hagen.de.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Koutsandréou', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Murillo-Rodríguez', 'Affiliation': 'Escuela de Medicina, División Ciencias de la Salud, Universidad Anáhuac Mayab Mérida, Mérida, Yucatán, Mexico.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Wegner', 'Affiliation': 'Department of Sport Psychology, Institute of Sports Science, Humboldt University Berlin, Berlin, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Budde', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113168']
1987,32916607,Timing of randomization after an acute coronary syndrome in patients with type 2 diabetes mellitus.,"BACKGROUND


The timing of enrolment following an acute coronary syndrome (ACS) may influence cardiovascular (CV) outcomes and potentially treatment effect in clinical trials. Understanding the timing and type of clinical events after an ACS will allow for clinicians to better tailor evidence-based treatments to optimize therapeutic effect. Using a large contemporary trial in patients with type 2 diabetes mellitus (T2DM) post-ACS, we examined the impact of timing of enrolment on subsequent CV outcomes.
METHODS


EXAMINE was a randomized trial of alogliptin versus placebo in 5,380 patients with T2DM and a recent ACS from October 2009 to March 2013. The primary outcome was a composite of CV death, nonfatal myocardial infarction (MI), or nonfatal stroke. The median follow-up was 18 months. In this post hoc analysis, we examined the occurrence of subsequent CV events by timing of enrollment divided by tertiles of time from ACS to randomization: 8-34, 35-56, and 57-141 days.
RESULTS


Patients randomized early (compared to the latest times) had less comorbidities at baseline including a history of heart failure (HF; 24.7% vs 33.0%), prior coronary artery bypass graft (9.6% vs 15.9%), or atrial fibrillation (5.9% vs 9.4%). Despite the reduced comorbidity burden, the risk of the primary outcome was highest in patients randomized early compared to the latest time (adjusted hazard ratio 1.47; 95% CI 1.21-1.74). Similarly, patients randomized early had an increased risk of recurrent MI (adjusted hazard ratio 1.51; 95% CI 1.17-1.96) and HF hospitalization (1.49; 95% CI 1.05-2.10).
CONCLUSIONS


In a contemporary cohort of T2DM with a recent ACS, the risk for recurrent CV events including MI and HF hospitalization is elevated early after an ACS. Given the emergence of antihyperglycemic therapies that reduce the risk of MI and HF among patients with T2DM at high CV risk, future studies evaluating the initiation of these therapies in the early period following an ACS are warranted given the large burden of potentially modifiable CV events.",2020,"Similarly, patients randomized early had an increased risk of recurrent MI (adjusted hazard ratio 1.51; 95% CI 1.17-1.96) and HF hospitalization (1.49; 95% CI 1.05-2.10).
","['patients with type 2 diabetes mellitus', 'patients with T2DM at high CV risk', '5,380 patients with T2DM and a recent ACS from October 2009 to March 2013', 'patients with type 2 diabetes mellitus (T2DM) post-ACS']",['alogliptin versus placebo'],"['risk of recurrent MI', 'atrial fibrillation', 'occurrence of subsequent CV events', 'prior coronary artery bypass graft', 'composite of CV death, nonfatal myocardial infarction (MI), or nonfatal stroke', 'history of heart failure', 'HF hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",5380.0,0.185278,"Similarly, patients randomized early had an increased risk of recurrent MI (adjusted hazard ratio 1.51; 95% CI 1.17-1.96) and HF hospitalization (1.49; 95% CI 1.05-2.10).
","[{'ForeName': 'Malik', 'Initials': 'M', 'LastName': 'Elharram', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada; DREAM-CV Lab, McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: Abhinav.sharma@mcgill.ca.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'White', 'Affiliation': 'University of Connecticut, Farmington, CT.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'University of Chicago Pritzker School of Medicine, Chicago, IL.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations cliniques-plurithématique 1433, Inserm U1116; CHRU Nancy; F-CRIN INI-CRCT network, Nancy, France.""}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Cambridge, MA; Cytel Corporation, Cambridge, MA, USA.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations cliniques-plurithématique 1433, Inserm U1116; CHRU Nancy; F-CRIN INI-CRCT network, Nancy, France.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations cliniques-plurithématique 1433, Inserm U1116; CHRU Nancy; F-CRIN INI-CRCT network, Nancy, France.""}]",American heart journal,['10.1016/j.ahj.2020.07.014']
1988,32916609,Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design.,"Cardiovascular disease (CVD) is a major cause of morbidity and mortality. Although it has been widely appreciated that obesity is a major risk factor for CVD, treatments that produce effective, durable weight loss and the impact of weight reduction in reducing cardiovascular risk have been elusive. Instead, progress in CVD risk reduction has been achieved through medications indicated for controlling lipids, hyperglycemia, blood pressure, heart failure, inflammation, and/or thrombosis. Obesity has been implicated as promoting all these issues, suggesting that sustained, effective weight loss may have independent cardiovascular benefit. GLP-1 receptor agonists (RAs) reduce weight, improve glycemia, decrease cardiovascular events in those with diabetes, and may have additional cardioprotective effects. The GLP-1 RA semaglutide is in phase 3 studies as a medication for obesity treatment at a dose of 2.4 mg subcutaneously (s.c.) once weekly. Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity (SELECT) is a randomized, double-blind, parallel-group trial testing if semaglutide 2.4 mg subcutaneously once weekly is superior to placebo when added to standard of care for preventing major adverse cardiovascular events in patients with established CVD and overweight or obesity but without diabetes. SELECT is the first cardiovascular outcomes trial to evaluate superiority in major adverse cardiovascular events reduction for an antiobesity medication in such a population. As such, SELECT has the potential for advancing new approaches to CVD risk reduction while targeting obesity.",2020,"GLP-1 receptor agonists (RAs) reduce weight, improve glycemia, decrease cardiovascular events in those with diabetes, and may have additional cardioprotective effects.","['patients with established CVD and overweight or obesity but without diabetes', 'People With Overweight or Obesity (SELECT', 'Patients with Overweight or Obesity (SELECT']","['placebo', 'GLP-1 receptor agonists (RAs']","['Cardiovascular Outcomes', 'Heart Disease and Stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0928799,"GLP-1 receptor agonists (RAs) reduce weight, improve glycemia, decrease cardiovascular events in those with diabetes, and may have additional cardioprotective effects.","[{'ForeName': 'Donna H', 'Initials': 'DH', 'LastName': 'Ryan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology and Department of Population and Data Sciences, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Deanfield', 'Affiliation': 'Farr Institute of Health Informatics Research at London, London, UK; National Institute for Cardiovascular Outcomes Research, University College London, London, United Kingdom.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Emerson', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'VA Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Kushner', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Marso', 'Affiliation': 'HCA Midwest Health Heart and Vascular Institute, Kansas City, MO.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Plutzky', 'Affiliation': ""Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Kirstine', 'Initials': 'K', 'LastName': 'Brown-Frandsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Marianne O L', 'Initials': 'MOL', 'LastName': 'Gronning', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'G Kees', 'Initials': 'GK', 'LastName': 'Hovingh', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark; Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Anders Gaarsdal', 'Initials': 'AG', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Ravn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Cleveland, OH. Electronic address: lincofa@ccf.org.'}]",American heart journal,['10.1016/j.ahj.2020.07.008']
1989,32919056,Exercise-induced changes in brain activity during memory encoding and retrieval after long-term bed rest.,"Episodic memory depends decisively on the hippocampus and the parahippocampal gyrus, brain structures that are also prone to exercise-induced neuroplasticity and cognitive improvement. We conducted a randomized controlled trial to investigate the effects of a high-intensity exercise program in twenty-two men resting in bed for 60 days on episodic memory and its neuronal basis. All participants were exposed to 60 days of uninterrupted bed rest. Eleven participants were additionally assigned to a high-intensity interval training that was performed five to six times weekly for 60 days. Episodic memory and its neural basis were determined four days prior to and on the 58th day of bed rest using functional magnetic resonance imaging (fMRI). We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly. These findings indicate a higher neuronal efficiency in the training group during memory encoding and retrieval and may suggest a dysfunctional mechanism in the non-exercising bed rest group induced by two months of physical inactivity. Our results provide further support for the modulating effects of physical exercise and adverse implications of a sedentary lifestyle and bedridden patients.",2020,We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly.,"['Eleven participants', 'twenty-two sedentary men resting in bed for 60 days on episodic memory and its neuronal basis']",['high-intensity exercise program'],"['BOLD signal', 'neuronal efficiency', 'brain activity']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",22.0,0.0382575,We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly.,"[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Friedl-Werner', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany; Université de Normandie, INSERM U 1075 COMETE, 14000 Caen, France.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Brauns', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Gunga', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany; Max-Planck-Institute for Human Development, Lise Meitner Group for Environmental Neuroscience, 14195 Berlin, Germany.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Stahn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany; Unit of Experimental Psychiatry, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA. Electronic address: astahn@pennmedicine.upenn.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117359']
1990,32919068,Effect of high-dose mineralocorticoid receptor antagonist eplerenone on urinary albumin excretion in patients with type 2 diabetes and high cardiovascular risk: Data from the MIRAD trial.,"AIM


As mineralocorticoid receptor antagonists (MRAs) may possess renoprotective effects in type 2 diabetes (T2D), it was decided to investigate the impact of high-dose MRA on prespecified secondary endpoints-namely, change in urinary albumin-creatinine ratio (UACR) and 24-h ambulatory blood pressure-in the MIRAD trial.
METHODS


This was a double-blind clinical trial in which T2D patients at high risk of or with established cardiovascular disease (CVD) were randomized to either high-dose (100-200 mg) eplerenone or a dose-matched placebo as an add-on to background antihypertensive treatment for 26 weeks. Safety was evaluated by the incidence of hyperkalaemia and kidney-related adverse events.
RESULTS


A total of 140 patients were enrolled (70 in each group). Baseline UACR was 17 mg/g (geometric mean; 95% CI: 13-22); this decreased by 34% in the eplerenone group compared with the placebo group at week 26 (95% CI: -51% to -12%; P =  0.005). There was no significant decrease in 24-h systolic blood pressure (SBP) due to treatment (-3 mmHg; 95% CI: -6 to 1; P = 0.150). However, the observed change in 24-h SBP correlated with the relative change in UACR in the eplerenone group (r = 0.568, P < 0.001). Mean baseline (± SD) estimated glomerular filtration rate (eGFR) was 85 (± 18.6) mL/min/1.73 m 2 , and 12 (± 9%) had an eGFR of 41-59 mL/min/1.73 m 2 . No significant differences in the incidence of mild hyperkalaemia (≥ 5.5 mmol/L; eplerenone vs placebo: 6 vs 2, respectively; P = 0.276) and no severe hyperkalaemia (≥ 6.0 mmol/L) were observed.
CONCLUSION


The addition of high-dose eplerenone to T2D patients at high risk of CVD can markedly reduce UACR with an acceptable safety profile.",2020,"No significant differences in the incidence of mild hyperkalaemia (≥ 5.5 mmol/L; eplerenone vs placebo: 6 vs 2, respectively; P =  0.276) and no severe hyperkalaemia (≥ 6.0 mmol/L) were observed.
","['T2D patients at high risk of or with established cardiovascular disease (CVD', 'type 2 diabetes (T2D', 'patients with type 2 diabetes and high cardiovascular risk', '140 patients were enrolled (70 in each group']","['eplerenone or a dose-matched placebo', 'high-dose mineralocorticoid receptor antagonist eplerenone', 'placebo', 'mineralocorticoid receptor antagonists (MRAs']","['24-h SBP', '24-h systolic blood pressure (SBP', 'UACR', 'Mean baseline (± SD) estimated glomerular filtration rate (eGFR', 'incidence of mild hyperkalaemia', 'urinary albumin-creatinine ratio (UACR) and 24-h ambulatory blood pressure', 'urinary albumin excretion', 'Baseline UACR', 'severe hyperkalaemia', 'incidence of hyperkalaemia and kidney-related adverse events']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",140.0,0.57451,"No significant differences in the incidence of mild hyperkalaemia (≥ 5.5 mmol/L; eplerenone vs placebo: 6 vs 2, respectively; P =  0.276) and no severe hyperkalaemia (≥ 6.0 mmol/L) were observed.
","[{'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Brandt-Jacobsen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Johansen', 'Affiliation': 'Department of Endocrinology-Internal Medicine, Copenhagen University Hospital, Herlev-Gentofte Hospital.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark; Department of Internal Medicine, Holbæk Hospital, Denmark.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Section of Biostatistics, Department of Public Health, University of Copenhagen, Denmark.'}, {'ForeName': 'Maria Refsgaard', 'Initials': 'MR', 'LastName': 'Holm', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Endocrinology-Internal Medicine, Copenhagen University Hospital, Herlev-Gentofte Hospital; Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'Université de Lorraine, INSERM CIC Plurithémathique 1433, UMRS 1116 INSERM, CHRU Nancy, and FCRIN INI-CRCT, Nancy, France.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Department of Cardiology, Copenhagen University Hospital, Herlev-Gentofte Hospital, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. Electronic address: cnkistorp@dadlnet.dk.'}]",Diabetes & metabolism,['10.1016/j.diabet.2020.08.005']
1991,32925145,Long-term employment status and quality of life after cancer: A longitudinal prospective cohort study from diagnosis up to and including 5 years post diagnosis.,"BACKGROUND


Accumulating evidence suggests that cancer survivors are able to return to work. However, little is known about their work situation 5 years after diagnosis.
OBJECTIVE


To explore fluctuations in employment status and its association with quality of life 2, 3, and 5 years after cancer diagnosis of 65 cancer survivors employed at diagnosis.
METHODS


In association with a randomised controlled trial (RCT), questionnaires were administrated to eligible cancer survivors at diagnosis, 2, 3, and 5 years thereafter comprising of validated questionnaires related to work (i.e. Work Ability Index (WAI), cancer, and quality of life (QOL) (i.e. SF-36, VAS QOL). The RCT studied a hospital-based work support intervention in female breast and gynaecological cancer survivors who were treated with curative intent and had paid work at diagnosis. Descriptive statistics and longitudinal multi-level analysis were employed.
RESULTS


Sixty-five of the 102 eligible cancer survivors participated, who were primarily diagnosed with breast cancer (63%). Two and 5 years after cancer diagnosis respectively 63 (97%) and 48 (81%) participants were employed. Reasons for not being employed after 5 years included receiving unemployment benefits (7%), voluntary unemployment (3%), receiving disability benefits (3%), and early retirement (3%). Longitudinal multi-level analysis showed that employed cancer survivors reported in general statistically significant better quality of life outcomes at 5 years follow-up compared to those not being employed.
CONCLUSIONS


We found high employment rates and few fluctuations in employment status. The steepest decline in employment rate occurs after the first two years of diagnosis. Employed participants reported better quality of life outcomes. Survivorship care should therefore focus on the population at risk possibly within the first two years after diagnosis.",2020,"Longitudinal multi-level analysis showed that employed cancer survivors reported in general statistically significant better quality of life outcomes at 5 years follow-up compared to those not being employed.
","['after a cancer', '65 cancer survivors employed at diagnosis', 'Sixty-five of the 102 eligible cancer survivors participated, who were primarily diagnosed with breast cancer (63', 'female breast and gynaecological cancer survivors who were treated with curative intent and had paid work at diagnosis', 'cancer survivors']",[],"['quality of life outcomes', 'voluntary unemployment', 'quality of life', 'Work Ability Index (WAI), cancer, and quality of life (QOL) (i.e. SF-36, VAS QOL', 'receiving disability benefits']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0222603', 'cui_str': 'Female mammary gland structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",102.0,0.062273,"Longitudinal multi-level analysis showed that employed cancer survivors reported in general statistically significant better quality of life outcomes at 5 years follow-up compared to those not being employed.
","[{'ForeName': 'Sietske J', 'Initials': 'SJ', 'LastName': 'Tamminga', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Lyanne P', 'Initials': 'LP', 'LastName': 'Jansen', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Monique H W', 'Initials': 'MHW', 'LastName': 'Frings-Dresen', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Angela G E M', 'Initials': 'AGEM', 'LastName': 'de Boer', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}]","Work (Reading, Mass.)",['10.3233/WOR-203234']
1992,32925765,"Influence of Baduanjin on lung function, exercise capacity, and quality of life in patients with mild chronic obstructive pulmonary disease.","INTRODUCTION


Chronic obstructive pulmonary disease (COPD) is an illness characterized by progressive aggravation of airflow limitation, which seriously affects patients' quality of life, and even life-threatening. The lung function of COPD patients is chronically and progressively deteriorated. Among them, the lung function of early COPD patients deteriorates rapidly, and forced expiratory volume in 1 second (FEV1) declines faster than other stages. If diagnosed early and effectively treated in time, it can greatly affect the prognosis. As a traditional exercise regimen, Baduanjin can improve lung function, exercise capacity, and quality of life of COPD patients. However, high-quality evidence-based medical evidence is so far be lacking to confirm the effectiveness of Baduanjin in reducing or preventing mild COPD lung function decline.
METHODS


This study is a randomized controlled trial, 192 patients with mild COPD were randomly divided into experimental group and control group. Both of them will receive basic treatment (health education and Tiotropium bromide), the experimental group will receive Baduanjin exercise training, and the control group will be told to maintain the original lifestyle and control the exercise. The Baduanjin exercise will last for 24 weeks and will be followed up for 72 weeks. The primary outcome is the change in lung function, including FEV1, FEV1/forced vital capacity (FVC), and FEV1/predicted. The secondary results included COPD assessment test, 6-minute walk test, St. George Respiratory Questionnaire, and Dyspnea Scale. Safety will also serve as assessing during the test.
DISCUSSION


The results of this trial will provide that traditional Baduanjin exercises can prevent COPD lung function deterioration, and provide a simple, inexpensive, and daily pulmonary rehabilitation measure for the patients with mild COPD.",2020,"As a traditional exercise regimen, Baduanjin can improve lung function, exercise capacity, and quality of life of COPD patients.","['192 patients with mild COPD', 'patients with mild COPD', 'Chronic obstructive pulmonary disease (COPD', 'patients with mild chronic obstructive pulmonary disease']","['Tiotropium bromide', 'traditional Baduanjin exercises', 'Baduanjin', 'Baduanjin exercise training']","['lung function of early COPD patients deteriorates rapidly, and forced expiratory volume', 'lung function, exercise capacity, and quality of life of COPD patients', 'COPD assessment test, 6-minute walk test, St. George Respiratory Questionnaire, and Dyspnea Scale', 'COPD lung function deterioration', 'lung function', 'change in lung function, including FEV1, FEV1/forced vital capacity (FVC), and FEV1/predicted', 'lung function, exercise capacity, and quality of life']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730604', 'cui_str': 'Mild chronic obstructive pulmonary disease'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C1306772', 'cui_str': 'tiotropium bromide'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}]",192.0,0.0380764,"As a traditional exercise regimen, Baduanjin can improve lung function, exercise capacity, and quality of life of COPD patients.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, P.R. China.'}, {'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Xialing', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Wujun', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022134']
1993,32928313,"A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


1- To compare the effectiveness of 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive patients. 2- To determine the salivary cytokine profiles of IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and IL- 17 among COVID-19 patients subjected to 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline or Neem extract (Azardirachta indica) based gargles.
TRIAL DESIGN


This will be a parallel group, quadruple blind-randomised controlled pilot trial with an add on laboratory based study.
PARTICIPANTS


A non-probability, purposive sampling technique will be followed to identify participants for this study. The clinical trial will be carried out at the Aga Khan University Hospital (AKUH), Karachi, Pakistan. The viral PCR tests will be done at main AKUH clinical laboratories whereas the immunological tests (cytokine analysis) will be done at the Juma research laboratory of AKUH. The inclusion criteria are laboratory-confirmed COVID-19 positive patients, male or female, in the age range of 18-65 years, with mild to moderate disease, already admitted to the AKUH. Subjects with low Glasgow coma score, with a history of radiotherapy or chemotherapy, who are more than 7 days past the onset of COVID- 19 symptoms, or intubated or edentulous patients will be excluded. Patients who are being treated with any form of oral or parenteral antiviral therapy will be excluded, as well as patients with known pre-existing chronic mucosal lesions such as lichen planus.
INTERVENTION AND COMPARATOR


Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene® by Aviro Health Inc./ Pyodine® by Brooks Pharma Inc.) for 20-30 seconds, thrice daily for 6 days. Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (HP® by Karachi Chemicals Products Inc./ ActiveOxy® by Boumatic Inc.) for 20-30 seconds, thrice daily for 6 days. Group C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated by Karachi University (chemistry department laboratories) for 20-30 seconds, thrice daily for 6 days. Group D (n=10) patients will use 2% hypertonic saline (Plabottle® by Otsuka Inc.) gargle and nasal lavage for a similar time period. Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days. For nasal lavage, a special douche syringe will be provided to each participant. Its use will be thoroughly explained by the data collection officer. After each use, the patient is asked not to eat, drink, or rinse their mouth for the next 30 minutes.
MAIN OUTCOMES


The primary outcome is the reduction in the intra-oral viral load confirmed with real time quantitative PCR.
RANDOMISATION


The assignment to the study group/ allocation will be done using the sealed envelope method under the supervision of Clinical Trial Unit (CTU) of Aga Khan University, Karachi, Pakistan. The patients will be randomised to their respective study group (1:1:1:1:1 allocation ratio) immediately after the eligibility assessment and consent administration is done.
BLINDING (MASKING)


The study will be quadruple-blinded. Patients, intervention provider, outcome assessor and the data collection officer will be blinded. The groups will be labelled as A, B, C, D or E. The codes of the intervention will be kept in lock & key at the CTU and will only be revealed at the end of study or if the study is terminated prematurely.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


As there is no prior work on this research question, so no assumptions for the sample size calculation could be made. The present study will serve as a pilot trial. We intend to study 50 patients in five study groups with 10 patients in each study group. For details, please refer to Fig. 1 for details.
TRIAL STATUS


Protocol version is 7.0, approved by the department and institutional ethics committees and clinical trial unit of the university hospital. Recruitment is planned to start as soon as the funding is sanctioned. The total duration of the study is expected to be 6 months i.e. August 2020-January 2021.
TRIAL REGISTRATION


This study protocol was registered at www.clinicaltrials.gov on 10 April 2020 NCT04341688 .
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). Fig. 1 Flow diagram of study-participants' timeline.",2020,Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive patients.,"['Subjects with low Glasgow coma score, with a history of radiotherapy or chemotherapy, who are more than 7 days past the onset of COVID- 19 symptoms, or intubated or edentulous patients', 'Aga Khan University Hospital (AKUH), Karachi, Pakistan', 'COVID-19 positive patients, male or female, in the age range of 18-65 years, with mild to moderate disease, already admitted to the AKUH', '50 patients in five study groups with 10 patients in each study group', 'hospitalised COVID-19 patients', 'Patients who are being treated with any form of oral or parenteral antiviral therapy will be excluded, as well as patients with known pre-existing chronic mucosal lesions such as lichen planus', 'COVID-19 positive patients']","['10 ml gargle and nasal lavage using 1% Hydrogen peroxide (HP® by Karachi Chemicals Products', 'Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline or Neem extract (Azardirachta indica) based gargles', 'Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution', '10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene® by Aviro Health Inc./ Pyodine® by Brooks Pharma Inc', 'hypertonic saline (Plabottle® by Otsuka Inc.) gargle and nasal lavage', '10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated by Karachi University (chemistry department laboratories', 'Neem extract (Azardirachta indica']","['reduction in the intra-oral viral load confirmed with real time quantitative PCR', 'intraoral viral load', 'salivary cytokine profiles of IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and IL']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0023646', 'cui_str': 'Lichen planus'}]","[{'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C2347335', 'cui_str': 'Azadirachta indica flower extract'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0007996', 'cui_str': 'Chemistry'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]",10.0,0.253668,Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive patients.,"[{'ForeName': 'Farhan Raza', 'Initials': 'FR', 'LastName': 'Khan', 'Affiliation': 'Department of Surgery, Aga Khan University, Karachi, 74800, Pakistan. farhan.raza@aku.edu.'}, {'ForeName': 'Syed Murtaza Raza', 'Initials': 'SMR', 'LastName': 'Kazmi', 'Affiliation': 'Department of Surgery, Aga Khan University, Karachi, 74800, Pakistan.'}, {'ForeName': 'Najeeha Talat', 'Initials': 'NT', 'LastName': 'Iqbal', 'Affiliation': 'Department of Pediatrics & Child Health, Aga Khan University, Karachi, 74800, Pakistan.'}, {'ForeName': 'Junaid', 'Initials': 'J', 'LastName': 'Iqbal', 'Affiliation': 'Department of Pediatrics & Child Health, Aga Khan University, Karachi, 74800, Pakistan.'}, {'ForeName': 'Syed Tariq', 'Initials': 'ST', 'LastName': 'Ali', 'Affiliation': 'Department of Chemistry, University of Karachi, Karachi, 75271, Pakistan.'}, {'ForeName': 'Syed Akbar', 'Initials': 'SA', 'LastName': 'Abbas', 'Affiliation': 'Department of Surgery, Aga Khan University, Karachi, 74800, Pakistan.'}]",Trials,['10.1186/s13063-020-04634-2']
1994,32910653,Efficient Training of Machine Learning Potentials by a Randomized Atomic-System Generator.,"Machine learning potentials provide an efficient and comprehensive tool to simulate large-scale systems inaccessible by conventional first-principles methods still in a similar level of accuracy. One critical issue in constructing machine learning potentials is to build training data sets cost-effectively that can represent the potential energy surface in a wide range of configurations. We develop a scheme named randomized atomic-system generator (RAG) to produce the training sets that widely cover the potential energy surface by combining the random sampling and structural optimization. We apply the scheme to construct the machine learning potentials for simulation of chalcogen-based phase change materials. Constructed machine learning potentials successfully simulate the dynamics of melting and crystallization processes of binary GeTe at a level comparable to first-principles simulations. The visual analysis shows that the RAG-generated training set represents the crystallization process including the amorphous phases. From the velocity autocorrelation function obtained from the molecular dynamics simulations, we calculate the phonon density of states to analyze the vibrational properties during crystallization.",2020,Machine learning potentials provide an efficient and comprehensive tool to simulate large scale systems inaccessible by conventional first-principles methods still in a similar level of accuracy.,[],[],[],[],[],[],1.0,0.0164004,Machine learning potentials provide an efficient and comprehensive tool to simulate large scale systems inaccessible by conventional first-principles methods still in a similar level of accuracy.,"[{'ForeName': 'Young-Jae', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'Department of Physics, POSTECH, Cheongam-ro 77, Pohang 37673, Republic of Korea.'}, {'ForeName': 'Seung-Hoon', 'Initials': 'SH', 'LastName': 'Jhi', 'Affiliation': 'Department of Physics, POSTECH, Cheongam-ro 77, Pohang 37673, Republic of Korea.'}]",The journal of physical chemistry. B,['10.1021/acs.jpcb.0c05075']
1995,32905863,Behavioral and neurological effects of tDCS on speech motor recovery: A single-subject intervention study.,"This paper reports a feasibility study designed to evaluate the behavioral and neurological effects of using transcranial direct current stimulation (tDCS) in conjunction with speech motor learning treatment for individuals with acquired speech impairment subsequent to stroke. Most of the research using tDCS to enhance treatment outcomes in stroke recovery has focused on either limb motor control or aphasia treatment. Using a multiple-baseline multiple-probe crossover design, we compared both behavioral and brain connectivity-based outcomes following speech motor learning treatment with both Active tDCS and Sham tDCS. We observed that both treatment phases led to improvement in short-term maintenance, but that Active tDCS was associated with greater long-term maintenance improvement. Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment. This report supports the possibility that tDCS may enhance both behavioral and neurological outcomes and indicates the importance of additional work in this area, although replication is required to confirm the extent and consistency of tDCS benefits on speech motor learning treatment outcomes.",2020,Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment.,['individuals with acquired speech impairment subsequent to stroke'],"['speech motor learning treatment with both Active tDCS and Sham tDCS', 'transcranial direct current stimulation (tDCS', 'tDCS', 'speech motor learning treatment']","['functional connectivity', 'speech motor recovery']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0037822', 'cui_str': 'Speech disorder'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",,0.0164864,Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Buchwald', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA. Electronic address: buchwald@nyu.edu.'}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Khosa', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Rimikis', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA.'}, {'ForeName': 'E Susan', 'Initials': 'ES', 'LastName': 'Duncan', 'Affiliation': 'Louisiana State University, Department of Communication Sciences and Disorders, 68 Hatcher Hall, Baton Rouge, LA 70803, USA.'}]",Brain and language,['10.1016/j.bandl.2020.104849']
1996,32905889,Role of inhaled corticosteroids in reducing exacerbations in bronchiectasis patients with blood eosinophilia pooled post-hoc analysis of 2 randomized clinical trials.,,2020,,['bronchiectasis patients with blood eosinophilia'],['inhaled corticosteroids'],[],"[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0014457', 'cui_str': 'Eosinophilia'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.174446,,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martinez-Garcia', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain. Electronic address: mianmartinezgarcia@gmail.com.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Posadas', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Sotgiu', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saderi', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy. Electronic address: lsaderi@uniss.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Aliberti', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}]",Respiratory medicine,['10.1016/j.rmed.2020.106127']
1997,32905893,12-months follow-up of pulmonary tele-rehabilitation versus standard pulmonary rehabilitation: A multicentre randomised clinical trial in patients with severe COPD.,"Between March 2016 and October 2017, we randomised 134 patients with severe COPD from 8 hospitals in the Capital Region of Denmark to participate in either standardised, outpatient pulmonary rehabilitation (control group) or on-line, supervised and home-based tele-rehabilitation (intervention group). We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme. The current study presents results from the 12-month follow-up with assessment of the 6MWD and analyses of hospitalisation and mortality. There were no significant differences between or within the groups in the 6MWD one year after completion of the programme.",2020,We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme.,"['134 patients with severe COPD from 8 hospitals in the Capital Region of Denmark to participate in either standardised, outpatient', 'patients with severe COPD']","['pulmonary rehabilitation (control group) or on-line, supervised and home-based tele-rehabilitation (intervention group', 'pulmonary tele-rehabilitation versus standard pulmonary rehabilitation']",['minutes walking distance (6MWD'],"[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",134.0,0.0811644,We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme.,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Godtfredsen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark; Institute for Clinical Medicine, University of Copenhagen, Denmark. Electronic address: Nina.Skavlan.Godtfredsen@regionh.dk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Frølich', 'Affiliation': 'The Research Unit for General Practice, Department of Public Health, University of Copenhagen, And Innovation and Research Centre for Multimorbidity and Chronic Conditions, Region Zealand, Denmark.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Department of Physical & Occupational Therapy, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Beyer', 'Affiliation': 'Institute for Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'Clinical Research Center, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Torgny', 'Initials': 'T', 'LastName': 'Wilcke', 'Affiliation': 'Department of Respiratory Medicine, Gentofte and Herlev University Hospital, Gentofte, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle Frost', 'Initials': 'HF', 'LastName': 'Andreassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lavesen', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Hillerød University Hospital, Hillerød, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hansen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106129']
1998,32904701,Allopurinol in Patients with Pulmonary Hypertension Associated with Chronic Lung Disease.,"Background


Oxidative stress (OS) has been implicated in the development of pulmonary hypertension (PH) and ventricular hypertrophy. Xanthine oxidase is a well-recognised source of reactive oxygen species, which lead to OS. The aim of this proof of concept study was to assess whether allopurinol (xanthine oxidase inhibitor) would reduce right ventricular mass (RVM) in patients with PH-associated chronic lung disease (PH-CLD).
Methods


We conducted a randomised, double-blind, parallel-group, placebo-controlled trial in patients with PH-CLD (93% COPD, 7% IPF) who were randomly assigned to receive allopurinol or placebo for 12 months. The primary outcome was the mean change in RVM, as assessed by cardiac magnetic resonance imaging (CMRI). Secondary outcomes included quality of life (QOL), spirometry and six-minute walk test (6MWT).
Results


Seventy-one patients were recruited: mean age 71 years, mean pulmonary arterial pressure 30 mm Hg, FEV 1  60% and resting SpO 2  96%. After 12 months, there was no significant difference in the change in RVM from baseline (allopurinol 1.85g vs placebo 0.97g with mean difference 0.88g, CI -4.77 to 3.01, p =0.7). There were also no significant changes in other cardiac parameters measured on MRI, in QOL, spirometry and 6MWT. Subgroup analysis showed that allopurinol significantly reduced RVM compared to placebo with -6.16g vs 0.75g and mean difference 6.92g (CI 1.14 to 12.69, p = 0.02) in COPD patients with more severe airflow limitation.
Conclusion


Allopurinol had no overall impact on patients with PH-CLD but had potential benefit in COPD patients with more severe airflow limitation.",2020,"There were also no significant changes in other cardiac parameters measured on MRI, in QOL, spirometry and 6MWT.","['patients with PH-CLD (93% COPD, 7% IPF', 'Seventy-one patients were recruited: mean age 71 years, mean pulmonary arterial\xa0pressure 30 mm Hg, FEV 1  60% and resting SpO 2  96', 'Patients with Pulmonary Hypertension Associated with Chronic Lung Disease', 'patients with PH-associated chronic lung disease (PH-CLD', 'COPD patients with more severe airflow limitation']","['allopurinol (xanthine oxidase inhibitor', 'placebo', 'Allopurinol', 'allopurinol or placebo', 'allopurinol', 'Xanthine oxidase']","['change in RVM', 'cardiac parameters measured on MRI, in QOL, spirometry and 6MWT', 'right ventricular mass (RVM', 'mean change in RVM, as assessed by cardiac magnetic resonance imaging (CMRI', 'quality of life (QOL), spirometry and six-minute walk test (6MWT', 'RVM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0055926', 'cui_str': 'clonidine-displacing substance'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3854605', 'cui_str': 'Mean pulmonary arterial pressure'}, {'cui': 'C0450396', 'cui_str': '30mm'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0302609', 'cui_str': 'Xanthine oxidase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043317', 'cui_str': 'Xanthine oxidase'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455860', 'cui_str': 'Right ventricular mass'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",71.0,0.743189,"There were also no significant changes in other cardiac parameters measured on MRI, in QOL, spirometry and 6MWT.","[{'ForeName': 'Patrick S K', 'Initials': 'PSK', 'LastName': 'Liu-Shiu-Cheong', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Lipworth', 'Affiliation': 'Scottish Centre for Respiratory Research, Medical Research Institute, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Weir-McCall', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'J Graeme', 'Initials': 'JG', 'LastName': 'Houston', 'Affiliation': 'Imaging Science and Technology, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Dundee DD1 9SY, UK.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S260917']
1999,32915972,Ibrutinib added to 10-day decitabine for older patients with AML and higher risk MDS.,"The treatment of older, unfit patients with acute myeloid leukemia (AML) is challenging. Based on preclinical data of Bruton tyrosine kinase expression/phosphorylation and ibrutinib cytotoxicity in AML blasts, we conducted a randomized phase 2 multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in unfit (ie, Hematopoietic Cell Transplantation Comorbidity Index ≥3) AML patients and higher risk myelodysplasia patients (HOVON135/SAKK30/15 trial). In total, 144 eligible patients were randomly (1:1) assigned to either 10-day decitabine combined with ibrutinib (560 mg; sequentially given, starting the day after the last dose of decitabine) (n = 72) or to 10-day decitabine (n = 72). The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms. In the decitabine plus ibrutinib arm, 41% reached complete remission/complete remission with incomplete hematologic recovery (CR/CRi), the median overall survival (OS) was 11 months, and 2-year OS was 27%; these findings compared with 50% CR/CRi, median OS of 11.5 months, and 2-year OS of 21% for the decitabine group (not significant). Extensive molecular profiling at diagnosis revealed that patients with STAG2, IDH2, and ASXL1 mutations had significantly lower CR/CRi rates, whereas patients with mutations in TP53 had significantly higher CR/CRi rates. Furthermore, multicolor flow cytometry revealed that after 3 cycles of treatment, 28 (49%) of 57 patients with available bone marrow samples had no measurable residual disease. In this limited number of cases, measurable residual disease revealed no apparent impact on event-free survival and OS. In conclusion, the addition of ibrutinib does not improve the therapeutic efficacy of decitabine. This trial was registered at the Netherlands Trial Register (NL5751 [NTR6017]) and has EudraCT number 2015-002855-85.",2020,"The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms.","['144 eligible patients', 'older, unfit patients with acute myeloid leukemia (AML', 'unfit (ie, Hematopoietic Cell Transplantation Comorbidity Index ≥3) AML patients and higher risk myelodysplasia patients (HOVON135/SAKK30/15 trial', 'older patients with AML and higher risk MDS']","['ibrutinib to 10-day decitabine', '10-day decitabine combined with ibrutinib', 'decitabine', '10-day decitabine', 'Ibrutinib added to 10-day decitabine']","['tolerability and efficacy', 'therapeutic efficacy of decitabine', '2-year OS', 'complete remission/complete remission with incomplete hematologic recovery (CR/CRi', 'number of adverse events', 'median overall survival (OS', 'CR/CRi rates']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",144.0,0.206533,"The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms.","[{'ForeName': 'Gerwin', 'Initials': 'G', 'LastName': 'Huls', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Chitu', 'Affiliation': 'Department of Hematology, HOVON Data Center, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Department of Oncology, University Hospital, Inselspital, and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Saskia K', 'Initials': 'SK', 'LastName': 'Klein', 'Affiliation': 'Department of Hematology, Meander Hospital Amersfoort, Amersfoort, The Netherlands.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Stussi', 'Affiliation': 'Department of Hematology, Ospedale Regionale, Bellinzona, Switzerland.'}, {'ForeName': 'Laimonas', 'Initials': 'L', 'LastName': 'Griskevicius', 'Affiliation': 'Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Peter J M', 'Initials': 'PJM', 'LastName': 'Valk', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Cloos', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Arjan A', 'Initials': 'AA', 'LastName': 'van de Loosdrecht', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Breems', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg/Middelheim, Antwerp, Belgium.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'van Lammeren-Venema', 'Affiliation': 'Department of Hematology, Hagaziekenhuis, Den Haag, The Netherlands.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'van Zeventer', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Rinske', 'Initials': 'R', 'LastName': 'Boersma', 'Affiliation': 'Department of Hematology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Mojca', 'Initials': 'M', 'LastName': 'Jongen-Lavrencic', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fehr', 'Affiliation': 'Department of Hematology, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Mels', 'Initials': 'M', 'LastName': 'Hoogendoorn', 'Affiliation': 'Department of Hematology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Markus G', 'Initials': 'MG', 'LastName': 'Manz', 'Affiliation': 'Department of Medical Oncology and Hematology, Universitätsspital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Söhne', 'Affiliation': 'Department of Hematology, Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Rien', 'Initials': 'R', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Department of Hematology, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Dries', 'Initials': 'D', 'LastName': 'Deeren', 'Affiliation': 'Department of Hematology, AZ Delta Roeselare, Roeselare, Belgium.'}, {'ForeName': 'Marjolein W M', 'Initials': 'MWM', 'LastName': 'van der Poel', 'Affiliation': 'Department of Hematology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Marie Cecile', 'Initials': 'MC', 'LastName': 'Legdeur', 'Affiliation': 'Department of Hematology, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Lidwine', 'Initials': 'L', 'LastName': 'Tick', 'Affiliation': 'Department of Hematology, Maxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Chalandon', 'Affiliation': 'Division of Hematology, University Hospital Genève and Faculty of Medicine, University of Genève, Genève, Switzerland; and.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Ammatuna', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Blum', 'Affiliation': 'Service and Central Laboratory of Hematology, Department of Oncology and Department of Laboratory Medicine and Pathology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Löwenberg', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Gert J', 'Initials': 'GJ', 'LastName': 'Ossenkoppele', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}]",Blood advances,['10.1182/bloodadvances.2020002846']
2000,32919098,Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids.,"BACKGROUND


Opioid overdose prevention education and naloxone distribution (OEND) programs include information on general risk factors, overdose recognition, and naloxone utilization. This study evaluated a personally-tailored OEND (PTOEND) intervention designed to promote harm reduction and treatment readiness for illicit opioid users by also including education about personal overdose-risk factors and medication for opioid use disorder (MOUD).
METHOD


A secondary analysis of a randomized controlled trial testing a Peer recovery support service (PRSS) intervention, relative to Control, in adult illicit opioid users reporting treatment for an overdose in the prior 6 months. PTOEND, a 30-minute computer-guided intervention, was administered by a research assistant at the randomization visit to all participants (N = 80). Participants completed a telephone visit 3 weeks post-randomization (n = 74) to assess changes in opioid overdose/MOUD knowledge and treatment readiness. Participants completed in-person visits at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization to assess illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors (12 months). We conducted pre-post analyses of the impact of PTOEND controlling for the PRSS effect.
RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05). Self-reported opioid use was significantly decreased at each follow-up (all p < 0.01). Self-reported overdose-risk behaviors decreased significantly (6.2 to 2.4, p < 0.01). A majority of participants (65 %) reported naloxone utilization.
CONCLUSIONS


PTOEND may be effective for promoting harm reduction and treatment readiness.",2020,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","['adult illicit opioid users reporting treatment for an overdose in the prior 6 months', 'individuals actively using illicit opioids']","['naloxone distribution intervention', 'Peer recovery support service (PRSS) intervention']","['Self-reported overdose-risk behaviors', 'Self-reported opioid use', 'knowledge of overdose', 'illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors', 'desire to quit all substances', 'MOUD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]",80.0,0.027065,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine 231, Albert Sabin Way, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108265']
2001,32919110,Fibroblast growth factor 23 concentrations and modifying factors in children from age 12 to 24 months.,"BACKGROUND AND OBJECTIVES


Fibroblast growth factor 23 (FGF23) participates in phosphate, calcium and vitamin D metabolism. In children these interactions and modifying factors are largely unknown.
PARTICIPANTS AND METHODS


This study evaluates temporal changes and modifiers of FGF23 concentrations from 12 to 24 months, in healthy children, participating in a randomized vitamin D intervention (VIDI). Participants received vitamin D 3  of 10 or 30 μg/day from age 2 weeks to 24 months. At 12 and 24 months, growth measurements and venous blood samples were obtained for analyses of intact (iFGF23) and C-terminal FGF23 (cFGF23), 25-hydroxyvitamin D (25-OHD), calcium, phosphate, parathyroid hormone, iron and ferritin. Changes in FGF23 and modifying factors were examined by linear mixed models.
RESULTS


The study included 594 infants. Girls had higher iFGF23 than boys (p < 0.001 for both 12 and 24 months), cFGF23 did not differ between the sexes. Adjusted mean iFGF23 decreased from 41.4 to 38.1 pg/mL in boys (p < 0.001) and from 45.2 to 42.5 pg/mL in girls (p = 0.002). Adjusted mean cFGF23 decreased from 2.89 to 2.00 pmol/L in boys (p < 0.001) and from 2.92 to 1.93 pmol/L in girls (p < 0.001). Iron modified FGF23 in both sexes, associating positively with iFGF23 and inversely with cFGF23. In girls, 25-OHD modified iFGF23. In boys, season modified FGF23, possibly through seasonal differences in 25-OHD. Vitamin D intervention dose did not affect FGF23.
CONCLUSIONS


FGF23 decreases from 12 to 24 months. Girls have higher iFGF23 than boys, at both time points. Iron modifies FGF23 in both sexes.",2020,Adjusted mean iFGF23 decreased from 41.4 to 38.1 pg/mL in boys (p<0.001) and from 45.2 to 42.5 pg/mL in girls (p=0.002).,"['594 infants', 'healthy children, participating in a randomized vitamin D intervention (VIDI', 'children from age 12 to 24 months']","['Vitamin D intervention', 'vitamin D']","['intact (iFGF23) and C-terminal FGF23 (cFGF23), 25-hydroxyvitamin D (25-OHD), calcium, phosphate, parathyroid hormone, iron and ferritin', 'cFGF23', 'Adjusted mean cFGF23', 'Adjusted mean iFGF23', 'growth measurements and venous blood samples']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1829744', 'cui_str': 'Fibroblast growth factor 23, C-terminal'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C1859049', 'cui_str': 'Haddad syndrome'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}]",594.0,0.0908647,Adjusted mean iFGF23 decreased from 41.4 to 38.1 pg/mL in boys (p<0.001) and from 45.2 to 42.5 pg/mL in girls (p=0.002).,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Enlund-Cerullo', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Folkhälsan Research Center, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland. Electronic address: maria.enlund@helsinki.fi.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hauta-Alus', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}, {'ForeName': 'Saara', 'Initials': 'S', 'LastName': 'Valkama', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Rosendahl', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}, {'ForeName': 'Sture', 'Initials': 'S', 'LastName': 'Andersson', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Mäkitie', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Folkhälsan Research Center, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland; Center for Molecular Medicine, Karolinska Institutet, Clinical Genetics, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Holmlund-Suila', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}]",Bone,['10.1016/j.bone.2020.115629']
2002,32919170,Is Moulage effective in improving clinical skills of nursing students for the assessment of pressure injury?,"BACKGROUND


In wound care simulations, the practice can be performed on 3D-wounds formed by moulage. Moulage helps the student to perceive the etiology, physiology, and healing processes of the wound, and it can also be used to improve the students' wound assessment skills.
OBJECTIVE


The aim of this study is to investigate the effectiveness of moulage in the improvement of pressure injury assessment skills of nursing students.
DESIGN


A quasi-experimental study.
SETTINGS


A nursing faculty at a public university.
PARTICIPANTS


All fourth-year students (n = 73) who take the simulation elective course were invited to participate.
METHODS


Fall semester students (n = 38) constituted the control group and spring semester students (n = 35) formed the intervention group. The coin-flipping method was used to match the education period and student groups. The intervention group simulation was performed using moulage, and the control group simulation was performed using a pressure ulcer visuals. The same simulation scenarios were used for both groups. The data were collected using the Simulation Design Scale, Student Satisfaction and Self-Confidence Scale, and student identification form, knowledge test, performance checklist and feedback form developed by the researchers.
RESULTS


Students' knowledge scores for pressure injury assessment have improved significantly in both the intervention group (pre-test:61.71 ± 9.77 and post-test 70.57 ± 12.53, t = -4.27, p < 0.001) and the control group (pre-test: 66.81 ± 13.47 and post-test 73.06 ± 15.50, t = -2.34, p = 0.02). Laboratory and clinical pressure injury assessment skill scores of the intervention group students were significantly higher than the control group. Besides, the correct staging percentages of the intervention group students are higher than the control group students during the clinical practice (χ2 = 5.05, p = 0.02).
CONCLUSIONS


It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.",2020,It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.,"['All fourth-year students (n\xa0=\xa073) who take the simulation elective course were invited to participate', 'Fall semester students (n\xa0=\xa038) constituted the control group and spring semester students (n\xa0=\xa035) formed the intervention group', 'nursing students']",[],"['Laboratory and clinical pressure injury assessment skill scores', 'knowledge scores for pressure injury assessment', 'Simulation Design Scale, Student Satisfaction and Self-Confidence Scale, and student identification form, knowledge test, performance checklist and feedback form developed by the researchers']","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]",[],"[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",73.0,0.0183299,It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.,"[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Sezgunsay', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Training and Research Hospital, Stoma and Wound Care Center, Ankara.'}, {'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Basak', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Faculty of Nursing, Fundamentals of Nursing Department, Ankara. Electronic address: tulay.basak@sbu.edu.tr.'}]",Nurse education today,['10.1016/j.nedt.2020.104572']
2003,32919196,Understanding the composite dimensions of the EQ-5D: An experimental approach.,"The EQ-5D(-5L) includes two composite dimensions: ""Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D), which involves an inherent ambiguity. Little is known about how these composite dimensions are interpreted across contexts where (i) individuals self-report their own health; and (ii) individuals value stylised health states. We detail the nature of the ambiguity and present experimental evidence from two large online surveys (n = 1007 and n = 1415). In one survey, individuals reported both their current health and their health at the time they felt the worst because of their health. In the other, they valued stylised EQ-5D states using Discrete Choice Experiments with duration as an attribute. In both surveys, participants were randomised into treatments in which the presentation of one of the composite dimensions was altered, or a control. Our results suggest (1) In self-report, use of the composite dimensions differs across the dimensions, with P/D used mainly to report Pain, but A/D used mainly to mean the more severe component of Anxiety and Depression. (2) In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level. (3) In valuation, the composite dimension P/D was interpreted to mean Pain, whilst the composite dimension A/D was interpreted to lie between Anxiety and Depression. We conclude that care must be taken when interpreting responses to existing health (or wellbeing) descriptive systems that rely on composite dimensions, and that caution should be applied when designing new ones.",2020,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.",[],['EQ-5D'],"['Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D', 'severe component of Anxiety and Depression']",[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0204719,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McDonald', 'Affiliation': 'University of Birmingham, UK. Electronic address: r.l.mcdonald@bham.ac.uk.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Mullett', 'Affiliation': 'University of Warwick, UK.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Tsuchiya', 'Affiliation': 'University of Sheffield, UK.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113323']
2004,32919280,No benefit of HDL mimetic CER-001 on carotid atherosclerosis in patients with genetically determined very low HDL levels.,"BACKGROUND AND AIMS


Infusion of high-density lipoprotein (HDL) mimetics failed to induce regression of atherosclerosis in recent randomized clinical trials. However, patients in these previous trials had normal levels of HDL-cholesterol, which potentially limited efficacy. Patients with very low levels of HDL-cholesterol and impaired cholesterol efflux capacity can be expected to derive the most potential benefit from infusion of HDL mimetics. This randomized clinical trial evaluated the efficacy of infusions of the HDL mimetic CER-001 in patients with genetically determined very low levels of HDL cholesterol.
METHODS


In this multicenter, randomized clinical trial, we recruited patients with familial hypoalphalipoproteinemia (due to ABCA1 and/or APOA1 loss-of-function variants). Participants were randomized to intravenous infusions of 8 mg/kg CER-001 or placebo (2:1 ratio), comprising 9 weekly infusions followed by infusions every two weeks. Patients underwent repeated 3T-MRI to assess mean vessel wall area and  18 F-FDG PET/CT to quantify arterial wall inflammation.
RESULTS


A total of 30 patients with a mean age of 52.7 ± 7.4 years and HDL-cholesterol of 0.35 ± 0.25 mmol/L were recruited. After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21). Furthermore, there was no significant difference in carotid arterial wall inflammation (n = 24, treatment difference: 0.10 target-to-background ratio of the most diseased segment, p = 0.33) after 24 weeks.
CONCLUSION


In patients with genetically determined very low HDL-cholesterol, 24 weeks of treatment with HDL mimetic CER-001 did not reduce carotid vessel wall dimensions or arterial wall inflammation, compared with placebo.",2020,"After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21).","['patients with genetically determined very low HDL levels', 'patients with genetically determined very low levels of HDL cholesterol', '30 patients with a mean age of 52.7\xa0±\xa07.4 years and HDL-cholesterol of 0.35\xa0±\xa00.25\xa0mmol/L were recruited', 'patients with genetically determined very low HDL-cholesterol, 24 weeks of treatment with', 'patients with familial hypoalphalipoproteinemia (due to ABCA1 and/or APOA1 loss-of-function variants']","['placebo', 'HDL mimetic CER-001', 'intravenous infusions of 8\xa0mg/kg CER-001 or placebo', 'repeated 3T-MRI']","['carotid arterial wall inflammation', 'absolute change in mean vessel wall area', 'normal levels of HDL-cholesterol', 'carotid atherosclerosis', 'carotid vessel wall dimensions or arterial wall inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704429', 'cui_str': 'Familial hypoalphalipoproteinemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3711161', 'cui_str': 'ABCA1 protein, human'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205419', 'cui_str': 'Variant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C3884609', 'cui_str': 'CER-001'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1097281', 'cui_str': '3-(3,4-dimethoxyphenyl)-1H-1,2,4-triazole'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0507850', 'cui_str': 'Wall of artery'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",30.0,0.409435,"After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21).","[{'ForeName': 'Kang H', 'Initials': 'KH', 'LastName': 'Zheng', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Kaiser', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Casper C', 'Initials': 'CC', 'LastName': 'van Olden', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Santos', 'Affiliation': 'Lipid Clinic Heart Institute (InCor), University of Sao Paulo Medical School Hospital, Sao Paulo, Brazil; Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Dasseux', 'Affiliation': 'Cerenis Therapeutics, Labège, Toulouse, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Genest', 'Affiliation': 'Department of Medicine, Division of Cardiology, McGill University, Montréal, Quebec, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'Department of Medicine, Université de Montréal, Chicoutimi, Quebec, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Westerink', 'Affiliation': 'Department of Vascular Medicine, Utrecht University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Keyserling', 'Affiliation': 'Cerenis Therapeutics, Labège, Toulouse, France.'}, {'ForeName': 'Hein J', 'Initials': 'HJ', 'LastName': 'Verberne', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Leitersdorf', 'Affiliation': 'Center for Research, Prevention and Treatment of Atherosclerosis, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hegele', 'Affiliation': 'Robarts Research Institute, Western University, London, Ontario, Canada.'}, {'ForeName': 'Olivier S', 'Initials': 'OS', 'LastName': 'Descamps', 'Affiliation': 'Centres Hospitaliers Jolimont, La Louvière, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hopkins', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Aart J', 'Initials': 'AJ', 'LastName': 'Nederveen', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands. Electronic address: e.s.stroes@amsterdamumc.nl.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.08.004']
2005,32920498,Ocrelizumab Treatment in Patients with Primary Progressive Multiple Sclerosis: Short-term Safety Results from a Compassionate Use Programme in Germany.,"OBJECTIVES


In January 2018, the European Union (EU) approved ocrelizumab in relapsing multiple sclerosis (RMS) and as the first disease-modifying therapy (DMT) for patients with primary progressive multiple sclerosis (PPMS) with efficacy proven in a phase 3 randomised controlled trial. Eleven months prior to the European regulatory approval, a compassionate use programme (CUP) made ocrelizumab available to 489 patients with PPMS in Germany, thereby for the first time providing a therapeutic option to patients with PPMS who could not participate in ocrelizumab studies. Here, we report real-world patient characteristics and short-term safety data of patients with PPMS treated with ocrelizumab in this CUP.
PATIENTS AND METHODS


This CUP was initiated in February 2017 - shortly before US Food and Drug administration approval in March 2017 - and ended in January 2018, following ocrelizumab approval in the EU. Adult patients (age ≥18 years) with PPMS who had a positive benefit/risk ratio according to the treating physician were eligible for inclusion at German treatment centres. The main exclusion criteria were current/recent treatment with other immune therapies and unresolved/chronic/active infections. Patients received methylprednisolone and an antihistamine before treatment with intravenous ocrelizumab in 6-month cycles. The first ocrelizumab dose was a 300 mg infusion followed by a second 300 mg infusion 2 weeks later; subsequent doses were delivered as a single 600 mg infusion. Adverse events were reported immediately.
RESULTS


Of 580 requests received from 104 centres, 525 patients met the eligibility criteria. Thirty-five patients did not participate due to withdrawal by the treating physician, and one due to death prior to treatment. A total of 489 patients received at least one 600 mg dose of ocrelizumab (administered as two 300 mg infusions) and 51 received a second dose. Due to termination of the CUP upon marketing authorisation, the maximum follow-up period was 12 months. Median patient age was 52 years (range: 24-73), and 49% were female. Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate. Patients with a previous malignancy, serious disease or infection (42 patients, 9%) had recovered from this prior to the CUP. Nine serious adverse events and 70 non-serious adverse events were reported in 40 patients. Adverse event categories were generally consistent with the known safety profile of ocrelizumab; one patient had carry-over progressive multifocal leukoencephalopathy (PML) due to previous natalizumab treatment.
CONCLUSION


This CUP provides first real-world observations of ocrelizumab for the treatment of PPMS in a large patient cohort in Germany, supporting that ocrelizumab is generally well-tolerated in clinical practice. Physicians should be vigilant for early symptoms of PML, as to date, 9 PML cases that were all confounded have been reported in patients treated with ocrelizumab worldwide, with 8 carry-over cases from a prior DMT.",2020,"Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate.","['489 patients with PPMS in Germany', '489 patients', 'Patients with Primary Progressive Multiple Sclerosis', '525 patients met the eligibility criteria', 'patients with primary progressive multiple sclerosis (PPMS', 'Adult patients (age ≥18 years) with PPMS who had a positive benefit/risk ratio according to the treating physician were eligible for inclusion at German treatment centres', 'patients with PPMS treated with ocrelizumab in this CUP', 'patients with PPMS who could not participate in ocrelizumab studies', 'Patients with a previous malignancy, serious disease or infection (42 patients, 9%) had recovered from this prior to the CUP', 'Of 580 requests received from 104 centres', 'Median patient age was 52 years (range: 24-73), and 49% were female', 'This CUP was initiated in February 2017 - shortly before US Food and Drug administration approval in March 2017 - and ended in January 2018, following ocrelizumab approval in the EU']","['ocrelizumab', 'methylprednisolone', 'intravenous ocrelizumab', 'glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate', 'antihistamine', 'Ocrelizumab']",['Adverse events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C2718016', 'cui_str': 'Compassionate Use'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015179', 'cui_str': 'European Community'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0289884', 'cui_str': 'glatiramer acetate'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",489.0,0.02963,"Previous immunomodulatory or immunosuppressive therapies had been received by 41% of patients, with the most commonly used being glucocorticoids, mitoxantrone, interferon-β and glatiramer acetate.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Rauer', 'Affiliation': 'Klinik für Neurologie und Neurophysiologie, Universitätsklinikum Freiburg, Freiburg, Germany. Electronic address: sebastian.rauer@uniklinik-freiburg.de.'}, {'ForeName': 'Muna-Miriam', 'Initials': 'MM', 'LastName': 'Hoshi', 'Affiliation': 'Neurologische Klinik, Technische Universität München, Munich, Germany. Electronic address: muna.hoshi@ms-klinik.de.'}, {'ForeName': 'Refik', 'Initials': 'R', 'LastName': 'Pul', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Essen, Essen, Germany. Electronic address: refik.pul@uk-essen.de.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Wahl', 'Affiliation': 'Zentrum der Neurologie und Neurochirugie, Universitätsklinikum Frankfurt, Frankfurt, Germany. Electronic address: wahl@med.uni-frankfurt.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwab', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Jena, Jena, Germany. Electronic address: matthias.schwab@med.uni-jena.de.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Haas', 'Affiliation': 'Jüdisches Krankenhaus Berlin, Berlin, Germany. Electronic address: judith.haas@jkb-online.de.'}, {'ForeName': 'Gisa', 'Initials': 'G', 'LastName': 'Ellrichmann', 'Affiliation': 'Klinik für Neurologie, St. Josef-Hospital, Bochum, Germany. Electronic address: gisa.ellrichmann@rub.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Krumbholz', 'Affiliation': 'Department of Neurology & Stroke and Hertie-Institute for Clinical Brain Research, Eberhard Karl University of Tübingen, Tübingen, Germany. Electronic address: markus.krumbholz@uni-tuebingen.de.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Tackenberg', 'Affiliation': 'Zentrum für Neuroimmunologie, Universitätsklinikum Marburg, Marburg, Germany; F. Hoffmann-La Roche AG, Basel, Switzerland. Electronic address: tackenbb@staff.uni-marburg.de.'}, {'ForeName': 'Kai-Uwe', 'Initials': 'KU', 'LastName': 'Saum', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: kai-uwe.saum@roche.com.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Buck', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: fabian.buck@roche.com.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Leemhuis', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: jost.leemhuis@roche.com.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kretschmann', 'Affiliation': 'Roche Pharma AG, Grenzach-Wyhlen, Germany. Electronic address: anita.kretschmann@roche.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Aktas', 'Affiliation': 'Klinik für Neurologie, Medizinische Fakultät, Universitätsklinikum Düsseldorf, Düsseldorf, Germany. Electronic address: orhan.aktas@med.uni-duesseldorf.de.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106142']
2006,32920607,Effect of bleaching protocols on surface roughness and color change of high- and low-viscosity bulk-fill composite resins.,"The aim of this in vitro study was to evaluate the effect of bleaching protocols on the surface roughness (Ra), color change and surface micromorphology of a low-viscosity bulk-fill composite (Filtek Bulk Fill Flow, 3M ESPE), a highviscosity bulk-fill composite (Filtek Bulk Fill, 3M ESPE) and a conventional nanoparticulate composite resin (control) (Filtek Z350 XT, 3M ESPE). Forty samples of each composite (disks 5 mm in diameter and 2 mm thick) were randomly divided into four groups (n=10), according to bleaching protocol: a) 10% carbamide peroxide gel (Opalescence, Ultradent Products) (2 h/ day, for 14 days); b) 40% hydrogen peroxide gel (Opalescence Boost, Ultradent Products) (three bleaching sessions, once a week, 45 min/session); c) whitening rinse (Listerine Whitening Extreme, Johnson & Johnson) (2 min/day, for 14 days); and d) distilled water (control). The samples were submitted to triplicate readings (Ra and color [CIELAB parameters]) before and after contact with bleaching protocols. Micromorphology was analyzed in a scanning electron microscope (SEM). Ra and color parameters (ΔL, Δa, Δb and ΔE) were analyzed by generalized linear models (α=0.05). The Ra of the high-viscosity bulk-fill was significantly higher than that of the other composites (p<0.05). Ra increased significantly (p<0.05) and surface became more irregular (SEM analysis) in all the composite resins, regardless of the bleaching protocol (p<0.05). The high-viscosity bulk-fill composite resin group had significantly lower ΔE (p<0.05) than the nanoparticulate composite resin group immersed in distilled water. It was concluded that the characteristics of each resin significantly influenced the Ra more than the bleaching protocol. The high-viscosity bulk-fill resin presented minor color change.",2020,"Ra increased significantly (p<0.05) and surface became more irregular (SEM analysis) in all the composite resins, regardless of the bleaching protocol (p<0.05).",['Forty samples of each composite (disks 5 mm in diameter and 2 mm thick'],"['whitening rinse (Listerine Whitening Extreme, Johnson & Johnson', 'conventional nanoparticulate composite resin (control', 'hydrogen peroxide gel (Opalescence Boost, Ultradent Products) (three bleaching sessions', 'bleaching protocols', 'bleaching protocol: a) 10% carbamide peroxide gel (Opalescence, Ultradent Products']","['Ra of the high-viscosity bulk-fill', 'Ra', 'surface roughness (Ra), color change and surface micromorphology of a low-viscosity bulk-fill composite (Filtek Bulk Fill Flow, 3M ESPE), a highviscosity bulk-fill composite (Filtek Bulk Fill, 3M ESPE', 'surface roughness and color change of high- and low-viscosity bulk-fill composite resins']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0065081', 'cui_str': 'Listerine'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0296695', 'cui_str': 'tooth-bleaching agent, Opalescence'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C4505780', 'cui_str': 'Filtek Bulk Fill'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]",,0.0174133,"Ra increased significantly (p<0.05) and surface became more irregular (SEM analysis) in all the composite resins, regardless of the bleaching protocol (p<0.05).","[{'ForeName': 'Bruna G', 'Initials': 'BG', 'LastName': 'Tavares', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, São Paulo, Brasil.'}, {'ForeName': 'Fabiana Mg', 'Initials': 'FM', 'LastName': 'França', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, São Paulo, Brasil.'}, {'ForeName': 'Roberta T', 'Initials': 'RT', 'LastName': 'Basting', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, São Paulo, Brasil.'}, {'ForeName': 'Cecilia P', 'Initials': 'CP', 'LastName': 'Turssi', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, São Paulo, Brasil.'}, {'ForeName': 'Flavia Lb', 'Initials': 'FL', 'LastName': 'Amaral', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, São Paulo, Brasil. flbamaral@gmail.com.'}]",Acta odontologica latinoamericana : AOL,[]
2007,32923850,Plasma Androgen Receptor Copy Number Status at Emergence of Metastatic Castration-Resistant Prostate Cancer: A Pooled Multicohort Analysis.,"PURPOSE


Increases in androgen receptor ( AR ) copy number (CN) can be detected in plasma DNA when patients develop metastatic castration-resistant prostate cancer. We aim to evaluate the association between  AR  CN as a continuous variable and clinical outcome.
PATIENTS AND METHODS


PCR2023 was an international, multi-institution, open-label, phase II study of abiraterone acetate plus prednisolone (AAP) or abiraterone acetate plus dexamethasone that included plasma  AR  assessment as a predefined exploratory secondary end point. Plasma  AR  CN data (ClinicalTrials.gov identifier: NCT01867710) from this study (n = 133) were pooled with data from the following three other cohorts: cohort A, which was treated with either AAP or enzalutamide (n = 73); the PREMIERE trial (ClinicalTrials.gov identifier: NCT02288936) of biomarkers for enzalutamide (n = 94); and a phase II trial from British Columbia (ClinicalTrials.gov identifier: NCT02125357) that randomly assigned men to either AAP or enzalutamide (n = 201). The primary outcome measures for the biomarker analysis were overall survival and progression-free survival.
RESULTS


Using multivariable fractional polynomials analysis using Cox regression models, a nonlinear relationship between plasma  AR  CN and outcome was identified for overall survival, where initially for small incremental gains in CN there was a large added hazard ratio that plateaued at higher CN. The CN cut point associated with the highest local hazard ratio was 1.92. A similar nonlinear association was observed with progression-free survival. In an exploratory analysis of PCR2023, the time from start of long-term androgen-deprivation therapy to start of AAP or abiraterone acetate plus dexamethasone was significantly shorter in patients with plasma  AR  CN of 1.92 or greater than patients with plasma  AR  CN of less than 1.92 (43  v  130 weeks, respectively;  P  = .005). This was confirmed in cohort A ( P  = .003), the PREMIERE cohort ( P  = .03), and the British Colombia cohort ( P  = .003).
CONCLUSION


Patients with metastatic castration-resistant prostate cancer can be dichotomized by a plasma  AR  CN cut point of 1.92. Plasma  AR  CN value of 1.92 or greater identifies aggressive disease that is poorly responsive to AR targeting and is associated with a prior short response to primary androgen-deprivation therapy.",2019,"This was confirmed in cohort A ( P  = .003), the PREMIERE cohort ( P  = .03), and the British Colombia cohort ( P  = .003).
","['patients develop metastatic castration-resistant prostate cancer', 'n = 133) were pooled with data from the following three other cohorts: cohort A, which was treated with either', 'Metastatic Castration-Resistant Prostate Cancer', 'Patients with metastatic castration-resistant prostate cancer']","['AAP or enzalutamide', 'enzalutamide', 'abiraterone acetate plus prednisolone (AAP) or abiraterone acetate plus dexamethasone', 'AAP or abiraterone acetate plus dexamethasone']","['progression-free survival', 'overall survival and progression-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",133.0,0.16697,"This was confirmed in cohort A ( P  = .003), the PREMIERE cohort ( P  = .03), and the British Colombia cohort ( P  = .003).
","[{'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Jayaram', 'Affiliation': 'University College London Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wingate', 'Affiliation': 'University College London Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wetterskog', 'Affiliation': 'University College London Cancer Institute, London, United Kingdom.'}, {'ForeName': 'Vincenza', 'Initials': 'V', 'LastName': 'Conteduca', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Istituto di Ricovero e Cura a Carattere Scientifico, Meldola, Italy.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Khalaf', 'Affiliation': 'Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mansour Taghavi Azar', 'Initials': 'MTA', 'LastName': 'Sharabiani', 'Affiliation': 'The School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Calabrò', 'Affiliation': 'San Camillo and Forlanini Hospitals, Rome, Italy.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Barwell', 'Affiliation': 'University of Glasgow, The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Studienpraxis Urologie, Nürtingen, Germany.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martinez-Carrasco', 'Affiliation': 'Hospital Universitario Morales Meseguer, Biobanco Nodo 3, Instituto Murciano de Investigación Biosanitaria-Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Font', 'Affiliation': ""Institut Catala d'Oncologia-Hospital Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Berruti', 'Affiliation': 'University of Brescia, Spedali Civili Hospital, Brescia, Italy.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Englander Institute for Precision Medicine, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow, The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Lefresne', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Lahaye', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Shibu', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Janssen Research and Development, Spring House, PA.'}, {'ForeName': 'Shilpy', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'HireGenics, Duluth, GA.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': 'Janssen Research and Development, Spring House, PA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ricci', 'Affiliation': 'Janssen Research and Development, Spring House, PA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gormley', 'Affiliation': 'Janssen Research and Development, Spring House, PA.'}, {'ForeName': 'Axel S', 'Initials': 'AS', 'LastName': 'Merseburger', 'Affiliation': 'University Hospital Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Institut de Recherche Clinique, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Annala', 'Affiliation': 'Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Istituto di Ricovero e Cura a Carattere Scientifico, Meldola, Italy.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gonzalez-Billalabeitia', 'Affiliation': 'Hospital Universitario Morales Meseguer, Biobanco Nodo 3, Instituto Murciano de Investigación Biosanitaria-Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Wyatt', 'Affiliation': 'Vancouver Prostate Centre, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'University College London Cancer Institute, London, United Kingdom.'}]",JCO precision oncology,['10.1200/PO.19.00123']
2008,32932009,"The preliminary effects of henna on chemotherapy-induced peripheral neuropathy in women receiving oxaliplatin-based treatment: A parallel-group, randomized, controlled pilot trial.","PURPOSE


Chemotherapy-induced peripheral neuropathy (CIPN) may frequently occur in patients receiving oxaliplatin-based treatment. The aim of the present parallel-group, randomized, controlled pilot trial was to investigate the effect of henna on CIPN in women receiving oxaliplatin-based treatment.
METHOD


Sixty female patients receiving oxaliplatin-based treatment were randomly divided into two groups, i.e., one intervention group (n = 30) where henna was applied topically and one control group (n = 30) that received routine treatment and care. Women in the intervention group were provided a pack of henna prepared by the investigators following each treatment course (2nd, 3rd, and 4th courses) and were instructed to apply the henna on their palms, fingers, and soles. The chemotherapy-induced peripheral neuropathy assessment tool (CIPNAT) was completed by women subsequent to the 2nd (baseline), 3rd, and 4th courses of treatment.
RESULTS


The intragroup assessment performed for the intervention group revealed that the total CIPNAT score significantly declined in the intervention group (p < 0.05). The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group × time interaction was η 2  = 0.169. Similarly, regarding the symptoms intervention section of the tool, a positive change by time in the intervention group was observed, and the effect size concerning this change was large, i.e., η 2  = 0.284.
CONCLUSIONS


The present study results showed that henna application on hands and feet has a beneficial effect on peripheral neuropathy. Applying henna is a promising approach in CIPN management.",2020,"The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group ","['women receiving oxaliplatin-based treatment', 'patients receiving oxaliplatin-based treatment', 'Sixty female patients receiving oxaliplatin-based treatment']","['henna was applied topically and one control group (n\xa0=\xa030) that received routine treatment and care', 'chemotherapy-induced peripheral neuropathy assessment tool (CIPNAT']",['total CIPNAT score'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0064698', 'cui_str': 'lawsone'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0266703,"The score changes by time in the intervention and control groups were in favour of the intervention group, and the effect size for group ","[{'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': 'Necmettin Erbakan University, Faculty of Nursing, Konya, Turkey. Electronic address: seldaarslan@erbakan.edu.tr.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Zorba Bahceli', 'Affiliation': 'Izmir Bakircay University, Faculty of Health Sciences, Nursing Department, Izmir, Turkey. Electronic address: pinarzorba85@gmail.com.'}, {'ForeName': 'Yeter', 'Initials': 'Y', 'LastName': 'İlik', 'Affiliation': 'Necmettin Erbakan University, Faculty of Medicine, Konya, Turkey. Electronic address: yeteriner@gmail.com.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Artaç', 'Affiliation': 'Necmettin Erbakan University, Faculty of Medicine, Konya, Turkey. Electronic address: mehmetartac@yahoo.com.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101827']
2009,32932051,Measuring upper limb disability for patients with neck pain: Evaluation of the feasibility of the single arm military press (SAMP) test.,"BACKGROUND


Non-specific neck pain (NSNP) is frequently associated with upper limb disability (ULD). Consequently, evaluation of ULD using an outcome measure is necessary during the management of patients with NSNP. The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain. During the SAMP test, patients are asked to repeatedly lift a weight above their head for 30 s. The number of repetitions is counted. Its clinical utility in a patient group is still unknown.
OBJECTIVE


This study investigates the feasibility of the SAMP test from patients and clinicians' perspectives.
METHODS


Seventy female patients with NSNP were randomly allocated into one of three groups. Participants in each group completed the SAMP test using one of three proposed weights (½kg, 1 kg or 1½kg). The feasibility of the SAMP test was established using structured qualitative exit feedback interviews for patients and administrating clinicians.
RESULTS


Participants using ½kg achieved the highest number of repetitions, but a high proportion reported the weight as extremely light, whereas those who tested using the 1½kg achieved the lowest number of repetitions and participants reported the weight as being heavy. Participants tested using 1 kg achieved an average number of repetitions and a high proportion reported the weight as acceptably heavy. Clinicians and patients reported that the SAMP test was efficient and convenient.
CONCLUSION


The 1 kg SAMP test is feasible for use in female patients with NSNP. The measurement properties of the SAMP test should be determined in a patient group.",2020,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[""patients and clinicians' perspectives"", 'patients and administrating clinicians', 'Seventy female patients with NSNP', 'female patients with NSNP', 'patients with NSNP', 'populations with neck pain', 'patients with neck pain']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],[],70.0,0.0379593,The Single Arm Military Press (SAMP) test is a performance-based ULD measure developed for populations with neck pain.,"[{'ForeName': 'Ahmad Salah Eldin', 'Initials': 'ASE', 'LastName': 'Alreni', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: Ahmad.Alreni@uantwerpen.be.'}, {'ForeName': 'Heba Roohy', 'Initials': 'HR', 'LastName': 'Abdo Aboalmaty', 'Affiliation': 'Department of Sports Training and Kinesiology, Tanta University El-Gaish Street, Tanta Qism 2, Tanta, Garbia Government, Egypt. Electronic address: hebaabdoaboalmaty@outlook.com.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: willem.dehertogh@uantwerpen.be.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Meirte', 'Affiliation': 'Faculty of Medicine and Health Science, University of Antwerp, Campus Drie Eiken, Universiteitsplein 1, D.R.319, 2610, Wilrijk, Belgium. Electronic address: jill.meirte@uantwerpen.be.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Harrop', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: D.Harrop@shu.ac.uk.'}, {'ForeName': 'Sionnadh Mairi', 'Initials': 'SM', 'LastName': 'McLean', 'Affiliation': 'Centre for Health and Social Care Research, Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, United Kingdom. Electronic address: s.mclean@shu.ac.uk.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102254']
2010,32932056,"Using Empathetic CAre and REsponse (ECARE) in improving empathy and confidence among nursing and medical students when managing dangerous, aggressive and violent patients in the clinical setting.","BACKGROUND


The use of physical restraint to curtail dangerous or extremely disruptive behaviours in patients has been an established practice to help ensuring safety in healthcare providers' work environment. However, many have deemed it unnecessary and overused with reported negligence on patients' basic needs during its implementation. Studies have shown that having empathy and non-judgmental attitudes are vital in reducing and eliminating the use of restraint.
OBJECTIVES


To explore whether experiential learning will improve empathy and confidence, among nursing and medical students when managing dangerous, aggressive, and violent patients.
DESIGN


A pre- and post-test, same group quasi-experimental design was used to explore the effectiveness of using the Empathetic CAre and REsponse (ECARE), an experiential learning session to equip nursing and medical students on managing dangerous, aggressive, and violent patients. Outcome measures include students' confidence when using verbal de-escalation, physical and chemical restraint techniques. Empathy scores were also compared.
SETTINGS


A University offering both medical and nursing program from undergraduate to postgraduate level.
PARTICIPANTS


249 nursing and 50 medical students undergoing the mental health nursing module in Year 2 of their nursing program and psychiatry rotation in Year 3 of their medical education.
RESULTS


Results showed that, for both student populations, the empathy and confidence scores significantly improved after attending ECARE. ANCOVA conducted on the post-intervention Jefferson empathy score between the populations with an adjusted baseline score revealed a statistically significant adjusted mean difference between them.
CONCLUSIONS


This study demonstrated that experiential learning could improve the learners' empathy through the integration of hands-on learning. This in turn could enhance future healthcare professionals' care quality. Experiential learning opportunities should be incorporated into existing pedagogies as this helps to improve students' confidence in managing dangerous, aggressive and violent patients, reducing the use of physical restraint, thereby enhancing the quality of patient care.",2020,"ANCOVA conducted on the post-intervention Jefferson empathy score between the populations with an adjusted baseline score revealed a statistically significant adjusted mean difference between them.
",['249 nursing and 50 medical students undergoing the mental health nursing module in Year 2 of their nursing program and psychiatry rotation in Year 3 of their medical education'],"['Empathetic CAre and REsponse (ECARE', 'experiential learning', 'Empathetic CAre and REsponse (ECARE), an experiential learning session']","['empathy and confidence scores', 'Empathy scores', ""students' confidence when using verbal de-escalation, physical and chemical restraint techniques""]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}]","[{'cui': 'C0243012', 'cui_str': 'Active Learning'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1320374', 'cui_str': 'Chemical restraint'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",249.0,0.0260366,"ANCOVA conducted on the post-intervention Jefferson empathy score between the populations with an adjusted baseline score revealed a statistically significant adjusted mean difference between them.
","[{'ForeName': 'Yong-Shian', 'Initials': 'YS', 'LastName': 'Goh', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Alice Lee Centre for Nursing Studies, National University Health System, Singapore. Electronic address: nurgys@nus.edu.sg.'}, {'ForeName': 'Yu-Ting Michelle', 'Initials': 'YM', 'LastName': 'Seetoh', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Alice Lee Centre for Nursing Studies, National University Health System, Singapore.'}, {'ForeName': 'Mui-Lee', 'Initials': 'ML', 'LastName': 'Chng', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Loong', 'Initials': 'L', 'LastName': 'Ong', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Institute of Mental Health, Singapore.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Alice Lee Centre for Nursing Studies, National University Health System, Singapore.'}, {'ForeName': 'Chun-Man Roger', 'Initials': 'CR', 'LastName': 'Ho', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Su Hui Cyrus', 'Initials': 'SHC', 'LastName': 'Ho', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}]",Nurse education today,['10.1016/j.nedt.2020.104591']
2011,32932174,"The effects of zinc supplementation on metabolic profile and oxidative stress in overweight/obese patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Evidence indicates the positive effects of zinc on insulin resistance and oxidative stress in metabolic syndrome or diabetes. Non-alcoholic fatty liver disease (NAFLD) is the main hepatic manifestation of insulin resistance and metabolic syndrome. The present study is the first clinical trial that evaluated the effects of zinc supplementation on metabolic and oxidative stress status in overweight/obese patients with NAFLD undergoing calorie- restriction diet.
METHODS


Fifty six overweight/obese patients with confirmed mild to moderate NAFLD using ultrasonography were randomly allocated to receive 30 mg elemental zinc supplement (n = 29) or placebo (n = 27) along with weight loss diet for 12 weeks. Serum levels of zinc, homeostasis model of assessment-estimated insulin resistance (HOMA-IR), lipid profile, serum superoxide dismutas1 (SOD1) and malondialdhyde (MDA) levels were assessed.
RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05). Within group comparison showed significant reduction in serum FBS, HbA 1C , TC, LDL-c and TG in the treatment group.
CONCLUSION


Zinc supplementation for three months improved insulin resistance and oxidative stress status in overweight/obese NAFLD patients with no beneficial effects on lipid profiles over weight loss diet. Registration ID in IRCT (IRCT NO: 20181005041238N1).",2020,"RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05).","['alcoholic fatty liver disease (NAFLD', 'overweight/obese patients with non-alcoholic fatty liver disease', 'metabolic syndrome or diabetes', 'overweight/obese patients with NAFLD undergoing calorie- restriction diet', 'overweight/obese NAFLD patients', 'Fifty six overweight/obese patients with confirmed mild to moderate NAFLD using ultrasonography']","['Zinc supplementation', '30\u202fmg elemental zinc supplement', 'IRCT', 'placebo', 'zinc supplementation']","['Serum levels of insulin, SOD1, MDA and HOMA-IR', 'serum FBS, HbA 1C , TC, LDL-c and TG', 'metabolic and oxidative stress status', 'insulin resistance and oxidative stress status', 'Serum levels of zinc, homeostasis model of assessment-estimated insulin resistance (HOMA-IR), lipid profile, serum superoxide dismutas1 (SOD1) and malondialdhyde (MDA) levels', 'metabolic profile and oxidative stress']","[{'cui': 'C0015696', 'cui_str': 'Alcoholic fatty liver'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",56.0,0.385469,"RESULTS


Serum levels of insulin, SOD1, MDA and HOMA-IR were improved in the treatment group (p < 0.05).","[{'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Fathi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pezhman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Imam Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Haidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Amani', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: r_amani@mail.mui.ac.ir.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126635']
2012,32933625,[Clinical effect of recombinant human interferon α1b adjuvant therapy in infectious mononucleosis: a prospective randomized controlled trial].,"OBJECTIVE


To study the clinical effect of recombinant human interferon α1b assisting acyclovir on immune function, inflammatory factors, and myocardial zymogram in children with infectious mononucleosis (IM).
METHODS


A total of 182 children with IM who were admitted to the hospital from January to December, 2018, were divided into an observation group with 91 children and a control group with 91 children using a random number table. The children in the control group were treated with intravenous drip of acyclovir, and those in the observation group were treated with inhalation of recombinant human interferon α1b in addition to the treatment in the control group. The two groups were compared in terms of clinical symptoms, immune function, inflammatory response, myocardial zymogram, and adverse reactions.
RESULTS


Compared with the control group, the observation group had significantly shorter time to body temperature recovery and disappearance of isthmopyra, cervical lymph node enlargement, hepatomegaly, and splenomegaly (P<0.05). After treatment, both groups had significant increases in CD4 + , CD4 + /CD8 + , and CD19 + , and the observation group had significantly higher levels of these markers than the control group (P<0.05). After treatment, both groups had significant reductions in the levels of CD8+, tumor necrosis factor-α, interlukin-6, creatine kinase, and creatine kinase-MB, and the treatment group had significantly lower levels of these markers than the control group (P<0.05). There was no significant difference in the incidence rate of adverse reactions between the two groups after treatment (P>0.05).
CONCLUSIONS


For children with IM, recombinant human interferon α1b assisting acyclovir can effectively improve immune function, inhibit inflammatory reaction, reduce myocardial injury, and thus alleviate clinical symptoms.",2020,"After treatment, both groups had significant reductions in the levels of CD8+, tumor necrosis factor-α, interlukin-6, creatine kinase, and creatine kinase-MB, and the treatment group had significantly lower levels of these markers than the control group (P<0.05).","['children with infectious mononucleosis (IM', '182 children with IM who were admitted to the hospital from January to December, 2018, were divided into an observation group with 91 children and a control group with 91 children using a random number table', 'infectious mononucleosis']","['intravenous drip of acyclovir', 'recombinant human interferon α1b', 'recombinant human interferon α1b assisting acyclovir', 'recombinant human interferon α1b adjuvant therapy']","['CD4 + , CD4 + /CD8 + , and CD19 ', 'levels of CD8+, tumor necrosis factor-α, interlukin-6, creatine kinase, and creatine kinase-MB', 'shorter time to body temperature recovery and disappearance of isthmopyra, cervical lymph node enlargement, hepatomegaly, and splenomegaly', 'incidence rate of adverse reactions', 'immune function, inflammatory factors, and myocardial zymogram', 'clinical symptoms, immune function, inflammatory response, myocardial zymogram, and adverse reactions']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}]","[{'cui': 'C1621368', 'cui_str': 'Drip Infusions'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0235592', 'cui_str': 'Cervical lymphadenopathy'}, {'cui': 'C0019209', 'cui_str': 'Large liver'}, {'cui': 'C0038002', 'cui_str': 'Splenomegaly'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",182.0,0.0339157,"After treatment, both groups had significant reductions in the levels of CD8+, tumor necrosis factor-α, interlukin-6, creatine kinase, and creatine kinase-MB, and the treatment group had significantly lower levels of these markers than the control group (P<0.05).","[{'ForeName': 'Sha-Sha', 'Initials': 'SS', 'LastName': 'Dai', 'Affiliation': ""Department of Infectious Diseases, Children's Hospital Affiliated to Nanjing Medical University, Nanjing 210000, China. kx06m1@163.com.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
2013,32903140,Age Dependency of the Prognostic Impact of Tumor Genomics in Localized Resectable  MYCN -Nonamplified Neuroblastomas. Report From the SIOPEN Biology Group on the LNESG Trials and a COG Validation Group.,"PURPOSE


For localized, resectable neuroblastoma without  MYCN  amplification, surgery only is recommended even if incomplete. However, it is not known whether the genomic background of these tumors may influence outcome.
PATIENTS AND METHODS


Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts: Localized Neuroblastoma European Study Group I/II and Children's Oncology Group. Genomic data were analyzed using multi- and pangenomic techniques and fluorescence in-situ hybridization in 2 age groups (cutoff age, 18 months) and were quality controlled by the International Society of Pediatric Oncology European Neuroblastoma (SIOPEN) Biology Group.
RESULTS


Patients with stage 1 tumors had an excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD], 95% ± 2%; 5-year overall survival [OS], 99% ± 1%). In contrast, patients with stage 2 tumors had a reduced EFS in both age groups (5-year EFS ± SD, 84% ± 3% in patients < 18 months of age and 75% ± 7% in patients ≥ 18 months of age). However, OS was significantly decreased only in the latter group (5-year OS ± SD in < 18months and ≥ 18months, 96% ± 2% and 81% ± 7%, respectively;  P  = .001). In < 18months, relapses occurred independent of segmental chromosome aberrations (SCAs); only 1p loss decreased EFS (5-year EFS ± SD in patients 1p loss and no 1p loss, 62% ± 13% and 87% ± 3%, respectively;  P  = .019) but not OS (5-year OS ± SD, 92% ± 8% and 97% ± 2%, respectively). In patients ≥ 18 months, only SCAs led to relapse and death, with 11q loss as the strongest marker (11q loss and no 11q loss: 5-year EFS ± SD, 48% ± 16% and 85% ± 7%,  P  = .033; 5-year OS ± SD, 46% ± 22% and 92% ± 6%,  P  = .038).
CONCLUSION


Genomic aberrations of resectable non- MYCN- amplified stage 2 neuroblastomas have a distinct age-dependent prognostic impact. Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months. In older patients with SCA, a randomized trial of postoperative chemotherapy compared with observation alone may be indicated.",2020,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","['older patients with SCA', 'Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts']",['postoperative chemotherapy'],"['excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD', 'EFS (5-year EFS ± SD', '5-year overall survival [OS', 'OS', 'relapse and death']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0953821,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","[{'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Gian-Paolo', 'Initials': 'GP', 'LastName': 'Tonini', 'Affiliation': 'Paediatric Research Institute, Fondazione Città della Speranza, Neuroblastoma Laboratory, Padua, Italy.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Pötschger', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gross', 'Affiliation': 'Pediatric Oncology Research, Department of Pediatrics, University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Mosseri', 'Affiliation': 'Service de Biostatistiques, Institut Curie, Paris, France.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Beiske', 'Affiliation': 'Department of Pathology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Berbegall', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bénard', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bown', 'Affiliation': 'Northern Genetics Service, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Huib', 'Initials': 'H', 'LastName': 'Caron', 'Affiliation': ""Department of Pediatric Oncology, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Combaret', 'Affiliation': 'Centre Léon Bérard, Laboratoire de Recherche Translationnelle, Lyon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Couturier', 'Affiliation': 'Unité de Génétique Somatique et Cytogénétique, Institut Curie, Paris, France.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Defferrari', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Delattre', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jeison', 'Affiliation': ""Ca-Cytogenetic Laboratory, Pediatric Hematology Oncology Department, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kogner', 'Affiliation': ""Childhood Cancer Research Unit, Karolinska Institutet, Astrid Lindgren Children's Hospital, Stockholm, Sweden.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lunec', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Marques', 'Affiliation': 'Centro de Genética Humana, Instituto Nacional de Saude doutor Ricardo Jorge, Lisbon, Portugal.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Martinsson', 'Affiliation': 'Department of Clinical Genetics, Institute of Biomedicine, University of Gothenburg, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Mazzocco', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Noguera', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Schleiermacher', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Valent', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Van Roy', 'Affiliation': 'Center for Medical Genetics, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Villamon', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Dasa', 'Initials': 'D', 'LastName': 'Janousek', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Pribill', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Glogova', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Attiyeh', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hogarty', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Monclair', 'Affiliation': 'Section for Paediatric Surgery, Division of Surgery, Rikshospitalet University Hospital, Oslo, Norway.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Holmes', 'Affiliation': ""Department of Paediatric Surgery, St George's Hospital, London, UK.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Valteau-Couanet', 'Affiliation': ""Département de Cancérologie de l'Enfant et de l'Adolescent, Gustave Roussy, Villejuif, France.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Castel', 'Affiliation': 'Unidad de Oncologia Pediatrica Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Tweddle', 'Affiliation': 'Wolfson Childhood Cancer Research Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital and University of Washington School of Medicine, Seattle, WA.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cohn', 'Affiliation': 'Department of Pediatrics, The University of Chicago, Chicago, IL.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ladenstein', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Beck-Popovic', 'Affiliation': 'Pediatric Hematology Oncology Unit, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'De Bernardi', 'Affiliation': ""Department of Paediatric Haematology and Oncology, Giannina Gaslini Children's Hospital, Genova, Italy.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Michon', 'Affiliation': 'Département de Pédiatrie, Institut Curie, Paris, France.'}, {'ForeName': 'Andrew D J', 'Initials': 'ADJ', 'LastName': 'Pearson', 'Affiliation': 'Institute of Cancer Research, Royal Marsden Hospital, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02132']
2014,32918135,Betaine and choline status modify the effects of folic acid and creatine supplementation on arsenic methylation in a randomized controlled trial of Bangladeshi adults.,"PURPOSE


Methylation of ingested inorganic arsenic (InAs) to monomethyl- (MMAs) and dimethyl-arsenical species (DMAs) facilitates urinary arsenic elimination. Folate and creatine supplementation influenced arsenic methylation in a randomized controlled trial. Here, we examine if baseline status of one-carbon metabolism nutrients (folate, choline, betaine, and vitamin B 12 ) modified the effects of FA and creatine supplementation on changes in homocysteine, guanidinoacetate (GAA), total blood arsenic, and urinary arsenic metabolite proportions and indices.
METHODS


Study participants (N = 622) received 400 or 800 μg FA, 3 g creatine, 400 μg FA + 3 g creatine, or placebo daily for 12 weeks.
RESULTS


Relative to placebo, FA supplementation was associated with greater mean increases in %DMAs among participants with betaine concentrations below the median than those with levels above the median (FDR < 0.05). 400 μg FA/day was associated with a greater decrease in homocysteine among participants with plasma folate concentrations below, compared with those above, the median (FDR < 0.03). Creatine treatment was associated with a significant decrease in %MMAs among participants with choline concentrations below the median (P = 0.04), but not among participants above the median (P = 0.94); this effect did not significantly differ between strata (P = 0.10).
CONCLUSIONS


Effects of FA and creatine supplementation on arsenic methylation capacity were greater among individuals with low betaine and choline status, respectively. The efficacy of FA and creatine interventions to facilitate arsenic methylation may be modified by choline and betaine nutritional status.
CLINICAL TRIAL REGISTRATION


Clinical Trial Registry Identifier: NCT01050556, U.S. National Library of Medicine, https://clinicaltrials.gov ; registered January 15, 2010.",2020,"400 μg FA/day was associated with a greater decrease in homocysteine among participants with plasma folate concentrations below, compared with those above, the median (FDR < 0.03).","['Study participants (N\u2009=\u2009622) received', 'Bangladeshi adults']","['folic acid and creatine supplementation', 'FA and creatine interventions', 'Folate and creatine supplementation', 'placebo, FA supplementation', 'FA and creatine supplementation', '400 or 800\xa0μg FA, 3\xa0g creatine, 400\xa0μg FA\u2009+\u20093\xa0g creatine, or placebo', 'ingested inorganic arsenic (InAs) to monomethyl- (MMAs) and dimethyl-arsenical species (DMAs']","['arsenic methylation', 'homocysteine, guanidinoacetate (GAA), total blood arsenic, and urinary arsenic metabolite proportions and indices', 'MMAs', 'homocysteine', 'arsenic methylation capacity']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0936225', 'cui_str': 'Inorganic arsenic'}, {'cui': 'C0003819', 'cui_str': 'Arsenic compound'}, {'cui': 'C0013013', 'cui_str': 'Commonwealth of Dominica'}]","[{'cui': 'C0003818', 'cui_str': 'Arsenic'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0120451', 'cui_str': 'guanidinoacetate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}]",,0.476248,"400 μg FA/day was associated with a greater decrease in homocysteine among participants with plasma folate concentrations below, compared with those above, the median (FDR < 0.03).","[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Bozack', 'Affiliation': 'Division of Pulmonary Medicine, Department of Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Caitlin G', 'Initials': 'CG', 'LastName': 'Howe', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Hall', 'Affiliation': 'Department of Epidemiology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, Columbia University, New York, NY, USA.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Slavkovich', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Ilievski', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Lomax-Luu', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Faruque', 'Initials': 'F', 'LastName': 'Parvez', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Abu B', 'Initials': 'AB', 'LastName': 'Siddique', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Shahriar', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad N', 'Initials': 'MN', 'LastName': 'Uddin', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tariqul', 'Initials': 'T', 'LastName': 'Islam', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Graziano', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Gamble', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA. mvg7@cumc.columbia.edu.'}]",European journal of nutrition,['10.1007/s00394-020-02377-z']
2015,32916132,The Impact of Prior Use of Corticosteroid to Dental Extraction on Oral Health-Related Quality-of-Life and Clinical Outcomes: A Randomized Clinical Trial.,"PURPOSE


To evaluate the impact of prior use of corticosteroids before dental extractions on oral health-related quality-of-life (OHRQoL).
METHODS


A randomized and triple-blind (patient, surgeon, and examiner) clinical trial was designed. The individuals were randomly allocated to 2 groups: test and placebo. In the test group, 2 capsules of 4 mg dexamethasone were administered orally. In the placebo group, subjects received 2 capsules with the same characteristics. In both groups, the administration took place 1 hour before the procedure. OHRQoL was assessed by the Brazilian version of Oral Health Impact Profile 14 (OHIP-14). The OHIP-14 questionnaire and the assessment methods for clinical parameters were collected preoperatively and postoperatively. Multilevel linear regression models fitted the associations between preoperative use of corticosteroids and overall and domain-specific OHIP-14 scores over time.
RESULTS


One hundred fourteen patients were selected for the study; however, 21 were excluded for not returning to postoperative control on the seventh day, resulting in 93 patients assessed (test = 44 and placebo = 49). The pain had a negative impact on OHRQoL (P < .01); however, the use of the drug had no statistically significant influence on OHRQoL (P = .62) and the clinical outcomes of pain (P = .63), mouth aperture (P = .05), and edema (P = .69).
CONCLUSIONS


The use of the 8 mg dexamethasone administered orally before the procedure was not effective on the improvement of the quality-of-life of patients undergoing dental extraction. However, using the medication seems to result in an improvement in the postoperative period of patients who had impacted teeth. Further research involving the analysis of OHRQoL must be performed, and other dosages and means of administration must be tested.",2020,The pain had a negative impact on OHRQoL,"['One hundred fourteen patients were selected for study; however, 21 were excluded for not returning to postoperative control on the seventh day, resulting in 93 patients assessed (test\xa0=\xa044 and placebo\xa0=\xa049', 'patients undergoing dental extraction']","['dexamethasone', 'placebo', 'OHRQoL', 'Corticosteroid to Dental Extraction']","['oral health-related quality of life (OHRQoL', 'OHRQoL', 'clinical outcomes of pain', 'Oral Health-Related Quality of Life and Clinical Outcomes', 'Brazilian version of Oral Health Impact Profile (OHIP-14', 'OHIP-14 questionnaire', 'quality of life', 'edema', 'mouth aperture']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",114.0,0.1098,The pain had a negative impact on OHRQoL,"[{'ForeName': 'Heitor B', 'Initials': 'HB', 'LastName': 'Pansard', 'Affiliation': ""MD Student, Health and Life Sciences Master's Student by the Franciscan University (UFN), Santa Maria, RS, Brazil.""}, {'ForeName': 'Mayara C', 'Initials': 'MC', 'LastName': 'Prado', 'Affiliation': ""MD Student, Health and Life Sciences Master's Student by the Franciscan University (UFN), Santa Maria, RS, Brazil.""}, {'ForeName': 'Gabriel F', 'Initials': 'GF', 'LastName': 'Marchi', 'Affiliation': 'Private Practitioner, Specialist in Bucco Maxillofacial Surgery and Traumatology, Santa Maria, RS, Brazil.'}, {'ForeName': 'Camila S', 'Initials': 'CS', 'LastName': 'Sfreddo', 'Affiliation': 'Professor, Dental School Professor of the Franciscan University (UFN), Santa Maria, RS, Brazil.'}, {'ForeName': 'Jovito A', 'Initials': 'JA', 'LastName': 'Skupien', 'Affiliation': ""Department Head, Health and Life Sciences Master's and Dental School of the Franciscan University (UFN), Santa Maria, RS, Brazil. Electronic address: skupien.ja@gmail.com.""}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.08.013']
2016,32916151,Synergistic effects of fructose and glucose on lipoprotein risk factors for cardiovascular disease in young adults.,"BACKGROUND


Fructose consumption increases risk factors for cardiometabolic disease. It is assumed that the effects of free sugars on risk factors are less potent because they contain less fructose. We compared the effects of consuming fructose, glucose or their combination, high fructose corn syrup (HFCS), on cardiometabolic risk factors.
METHODS


Adults (18-40 years; BMI 18-35 kg/m 2 ) participated in a parallel, double-blinded dietary intervention during which beverages sweetened with aspartame, glucose (25% of energy requirements (ereq)), fructose or HFCS (25% and 17.5% ereq) were consumed for two weeks. Groups were matched for sex, baseline BMI and plasma lipid/lipoprotein concentrations. 24-h serial blood samples were collected at baseline and at the end of intervention. Primary outcomes were 24-h triglyceride AUC, LDL-cholesterol (C), and apolipoprotein (apo)B. Interactions between fructose and glucose were assessed post hoc.
FINDINGS


145 subjects (26.0 ± 5.8 years; body mass index 25.0 ± 3.7 kg/m 2 ) completed the study. As expected, the increase of 24-h triglycerides compared with aspartame was highest during fructose consumption (25%: 6.66 mmol/Lx24h 95% CI [1.90 to 11.63], P = 0.0013 versus aspartame), intermediate during HFCS consumption (25%: 4.68 mmol/Lx24h 95% CI [-0.18 to 9.55], P = 0.066 versus aspartame) and lowest during glucose consumption. In contrast, the increase of LDL-C was highest during HFCS consumption (25%: 0.46 mmol/L 95% CI [0.16 to 0.77], P = 0.0002 versus aspartame) and intermediate during fructose consumption (25%: 0.33 mmol/L 95% CI [0.03 to 0.63], P = 0.023 versus aspartame), as was the increase of apoB (HFCS-25%: 0.108 g/L 95%CI [0.032 to 0.184], P = 0.001; fructose 25%: 0.072 g/L 95%CI [-0.004 to 0.148], P = 0.074 versus aspartame). The post hoc analyses showed significant interactive effects of fructose*glucose on LDL-C and apoB (both P < 0.01), but not on 24-h triglyceride (P = 0.340).
CONCLUSION


A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS. Thus, the effects of HFCS on lipoprotein risks factors are not solely mediated by the fructose content and it cannot be assumed that glucose is a benign component of HFCS. Our findings suggest that HFCS may be as harmful as isocaloric amounts of pure fructose and provide further support for the urgency to implement strategies to limit free sugar consumption.",2020,A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS.,"['young adults', 'Adults (18-40\u202fyears; BMI 18-35\u202fkg/m 2 ) participated in a']","['consuming fructose, glucose or their combination, high fructose corn syrup (HFCS', 'fructose and glucose', 'Fructose consumption', 'parallel, double-blinded dietary intervention during which beverages sweetened with aspartame, glucose (25% of energy requirements (ereq)), fructose or HFCS', 'HFCS']","['lipoprotein risk factors', '24-h triglycerides', 'LDL-C and apoB', '24-h triglyceride', '24-h serial blood samples', 'LDL-C', '24-h triglyceride AUC, LDL-cholesterol (C), and apolipoprotein (apo)B. Interactions between fructose and glucose']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C2981326', 'cui_str': 'High Fructose Corn Syrup'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement'}]","[{'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",145.0,0.0811716,A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS.,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hieronimus', 'Affiliation': 'Max Rubner-Institut, Institute of Child Nutrition, Karlsruhe, Germany; Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America. Electronic address: bettina.hieronimus@mri.bund.de.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Medici', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Bremer', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of California, Davis, CA, United States of America; Pediatric Growth and Nutrition Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States of America.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Lee', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Marinelle V', 'Initials': 'MV', 'LastName': 'Nunez', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Desiree M', 'Initials': 'DM', 'LastName': 'Sigala', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America; Department of Nutrition, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Keim', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, United States of America; United States Department of Agriculture, Western Human Nutrition Research Center, Davis, CA, United States of America.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Havel', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America; Department of Nutrition, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Kimber L', 'Initials': 'KL', 'LastName': 'Stanhope', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154356']
2017,32919400,"Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial.","Treatment-resistant depression (TRD) is prevalent and associated with a substantial psychosocial burden and mortality. There are few prior studies of interventions for TRD in adolescents. This was the largest study to date examining the feasibility, safety, and efficacy of 10-Hz transcranial magnetic stimulation (TMS) for adolescents with TRD. Adolescents with TRD (aged 12-21 years) were enrolled in a randomized, sham-controlled trial of TMS across 13 sites. Treatment resistance was defined as an antidepressant treatment record level of 1 to 4 in a current episode of depression. Intention-to-treat patients (n = 103) included those randomly assigned to active NeuroStar TMS monotherapy (n = 48) or sham TMS (n = 55) for 30 daily treatments over 6 weeks. The primary outcome measure was change in the Hamilton Depression Rating Scale (HAM-D-24) score. After 6 weeks of blinded treatment, improvement in the least-squares mean (SE) HAM-D-24 scores were similar between the active (-11.1 [2.03]) and sham groups (-10.6 [2.00]; P = 0.8; difference [95% CI], - 0.5 [-4.2 to 3.3]). Response rates were 41.7% in the active group and 36.4% in the sham group (P = 0.6). Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95). There were no new tolerability or safety signals in adolescents. Although TMS treatment produced a clinically meaningful change in depressive symptom severity, this did not differ from sham treatment. Future studies should focus on strategies to reduce the placebo response and examine the optimal dosing of TMS for adolescents with TRD.",2020,Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95).,"['Adolescents with TRD (aged 12-21 years', 'adolescents with TRD.Fig', 'adolescents with TRD', 'Intention-to-treat patients (n\u2009=\u2009103', 'adolescents']","['active NeuroStar TMS monotherapy (n\u2009=\u200948) or sham TMS', '10-Hz transcranial magnetic stimulation (TMS', 'TMS', 'Left prefrontal transcranial magnetic stimulation']","['depressive symptom severity', 'Response rates', 'Remission rates', 'least-squares mean (SE) HAM-D-24 scores', 'new tolerability or safety signals', 'Hamilton Depression Rating Scale (HAM-D-24) score', 'transcranial magnetic stimulation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",,0.481603,Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95).,"[{'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Croarkin', 'Affiliation': 'Division of Child and Adolescent Psychiatry and Psychology, Mayo Clinic Depression Center, Mayo Clinic, Rochester, Minnesota, USA. croarkin.paul@mayo.edu.'}, {'ForeName': 'Ahmed Z', 'Initials': 'AZ', 'LastName': 'Elmaadawi', 'Affiliation': 'Beacon Health System, South Bend, Indiana USA, Indiana University School of Medicine, South Bend, USA.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Aaronson', 'Affiliation': 'Sheppard Pratt Health System, Baltimore, Maryland, USA.'}, {'ForeName': 'G Randolph', 'Initials': 'GR', 'LastName': 'Schrodt', 'Affiliation': 'Integrative Psychiatry, Louisville, Kentucky, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Holbert', 'Affiliation': 'Shands Psychiatric Hospital, Gainesville, Florida, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Verdoliva', 'Affiliation': 'North American Science Associates, Inc. (NAMSA) Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Heart', 'Affiliation': 'Neuronetics, Inc. Malvern, Pennsylvania, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Trevena, Inc. Chesterbrook, Pennsylvania, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'Department of Psychiatry & Behavioral Neuroscience, University of Cincinnati, Cincinnati, Ohio, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00829-y']
2018,32920186,"An invited commentary on: ""A randomized controlled trial on irrigation of open appendectomy wound with gentamicin-saline solution versus saline solution for prevention of surgical site infection"" (International Journal of Surgery 2020).",,2020,,[],['Gentamicin-Saline Solution versus Saline Solution'],[],[],"[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.304305,,"[{'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Akay', 'Affiliation': 'Emergency Medicine Clinic, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey. Electronic address: howls_Castle@mynet.com.'}, {'ForeName': 'Huriye', 'Initials': 'H', 'LastName': 'Akay', 'Affiliation': 'Emergency Medicine Clinic, University of Health Sciences, Izmir Bozyaka Education and Research Hospital, Izmir, Turkey.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.09.009']
2019,32920219,COVID-19 associated kidney impairment in adult: Qualitative and quantitative analyses with non-enhanced CT on admission.,"PURPOSE


To qualitatively and quantitatively assess kidney imapairment in adults with COVID-19 by analysing imaging features on non-enhanced CT (NECT) and possible correlation between renal parenchymal attenuation (RPA) and serum creatinine (SCr) levels on admission.
METHODS


This study was approved by the local institutional ethics committee. A total of 82 patients with COVID-19 admitted from 10/1/2020∼15/3/2020 were enrolled. RPA and perinephric fat stranding (PFS) were evaluated on NECT imaging. According to the presence of PFS, the patients were divided into two groups: Group A, 38 patients with PFS, and Group B, 44 patients without PFS. Clinical data, including age, gender, clinical classification, SCr levels, and RPA on NECT were analysed. The RPA and SCr of the two groups with COVID-19 were analysed to determine possible difference and correlation. Eighty subjects with no kidney diseases were randomly selected as control group to determine the RPA of normal kidney performed on the same CT scanner.
RESULTS


Mean age, male to female ratio, number of severe and critical cases, and SCr of Group A were higher than those of Group B. Both mean RPA of Group A and Group B were lower than that of control. Mean RPA of Group A was even lower than that of Group B. A significant weak negative linear correlation between RPA on NECT and SCr in COVID-19 was indicated.
CONCLUSIONS


Decrease in RPA on NECT was observed in patients with COVID-19 and a weak linear negative correlation with SCr levels was found. The presence of PFS suggested more severe renal impairment in COVID-19. RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.",2020,RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.,"['82 patients with COVID-19 admitted from 10/1/2020∼15/3/2020 were enrolled', '38 patients with PFS, and Group B, 44 patients without PFS', 'adults with COVID-19 by analysing imaging features on non-enhanced CT (NECT', 'Eighty subjects with no kidney diseases']",[],"['Mean RPA', 'renal parenchymal attenuation (RPA) and serum creatinine (SCr) levels on admission', 'severe renal impairment', 'RPA on NECT', 'SCr levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0227617', 'cui_str': 'Structure of fatty capsule of kidney'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]",82.0,0.0205873,RPA measurements and PFS could be useful in quantitative and qualitative evaluation of COVID-19 associated renal impairment on admission.,"[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Electrocadiogram, Affiliated Hangzhou First People's Hospital, College of Medicine, Zhejiang University, 261 Huansha Road, 310006, Hangzhou, Zhejiang, People's Republic of China; Department of Cardiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Shuangzhi', 'Initials': 'S', 'LastName': 'Lyu', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Senxiang', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': ""Department of Radiation Oncology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Liangrong', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ""Department of Cardiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China. Electronic address: 1191066@zju.edu.cn.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, People's Republic of China. Electronic address: chenfenghz@zju.edu.cn.""}]",European journal of radiology,['10.1016/j.ejrad.2020.109240']
2020,32920228,"The effect of pain neurophysiology education on healthcare students' knowledge, attitudes and behaviours towards pain: A mixed-methods randomised controlled trial.","OBJECTIVE


1) To investigate the effects of a brief pain neuroscience education (PNE) lecture on multi-disciplinary healthcare students' knowledge, attitudes and behaviours towards people with pain post intervention and at 6-months follow-up, 2) To explore students' perceptions of PNE.
DESIGN


Mixed-methods randomized controlled trial.
SETTING


UK university.
PARTICIPANTS


Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines.
INTERVENTION


70-min PNE lecture (intervention group) or a 70-min control education.
MAIN OUTCOME MEASURES


1) Knowledge: The Revised Pain Neurophysiology Quiz (RPNQ); 2) Attitudes: Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS); 3) Behaviours: A case vignette to assess clinical recommendations; and 4) Thematic analysis of semi-structured interviews (n = 12).
RESULTS


The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860). Greater improvements in attitudes for the intervention group were seen post-intervention [-10.4 (-16.3, -4.6), P < 0.001] and at 6-months [-5.8 (-11.5, -0.2), P < 0.044]. There was no difference in behaviours between groups. Thematic analysis identified increased patient empathy, partial and patchy reconceptualisation of pain and increased confidence in recommending an active management programme following PNE.
CONCLUSION


This study adds to existing knowledge by demonstrating that a 70-min PNE lecture can have a short-term effect on knowledge and positively shift attitudes towards people with pain in the short and medium-term. It also resulted in some students' reconceptualisation of pain, increased empathy, and confidence to recommend activity. The effect of PNE on clinical behaviours was unclear.",2020,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","['UK university', 'healthcare students', 'Knowledge', 'Attitudes', 'Thirty-seven students (30♀, mean age 30 years) from six healthcare disciplines']","['pain neurophysiology education', 'pain neuroscience education (PNE) lecture', '70-min PNE lecture (intervention group) or a 70-min control education', 'PNE']","['knowledge', 'patient empathy, partial and patchy reconceptualisation of pain', ""Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS"", 'knowledge, attitudes and behaviours towards pain', 'pain, increased empathy, and confidence to recommend activity']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027901', 'cui_str': 'Neurophysiology'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3489398', 'cui_str': 'Peripheral neuroepithelioma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.210237,"The intervention group increased knowledge compared to the control, post-intervention [mean difference 3.7 (95% CI, 2.4, 5.0), P < 0.001] but not at 6-months (0.1 (-1.1, 1.3), P = 0.860).","[{'ForeName': 'Jagjit', 'Initials': 'J', 'LastName': 'Mankelow', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom. Electronic address: j.mankelow@tees.ac.uk.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, TS1 3BX, United Kingdom.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102249']
2021,32920242,Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185).,"BACKGROUND


The optimal surveillance strategy for pancreatic cysts, which occur in up to 20% of the adult population, is ill defined. The risk of malignant degeneration of these cysts is low, however the morbidity and mortality associated with pancreatic cancer are high. Two clinical surveillance guidelines are in regular use. Both the Fukuoka and American Gastroenterological Association (AGA) guidelines rely on radiographic and endoscopic imaging. They differ primarily in their recommended frequencies of interval surveillance imaging. While evidence driven clinical guidelines should promote higher quality care, competing guidelines on the same topic may provide discordant recommendations and potential reduction in the quality and/or value of care.
OBJECTIVES


The primary objective is to compare the clinical effectiveness of the two surveillance guidelines to identify patients most likely to benefit from pancreatic resection. Secondary objectives include comparison of resource utilization, patient reported outcomes, incidental findings are other clinical outcomes.
METHODS


4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance. All participants will be followed prospectively for 5 years.
CONCLUSION


Differing guidelines confuse providers, patients and policymakers. This large, prospective, randomized trial will compare the clinical effectiveness and resource allocation requirements of two guidelines addressing a common clinical entity. CLINICALTRIALS.
GOV IDENTIFIER


NCT04239573.",2020,"METHODS


4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance.","['4606 asymptomatic patients with newly identified pancreatic cysts ≥1\u202fcm in diameter', 'All participants will be followed prospectively for 5\u202fyears']",['high intensity (Fukuoka) or low intensity (AGA) surveillance'],"['comparison of resource utilization, patient reported outcomes, incidental findings are other clinical outcomes']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0030283', 'cui_str': 'Cyst of pancreas'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0743997', 'cui_str': 'Incidental Findings'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",4606.0,0.104339,"METHODS


4606 asymptomatic patients with newly identified pancreatic cysts ≥1 cm in diameter will be randomized 1:1 to high intensity (Fukuoka) or low intensity (AGA) surveillance.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Weinberg', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States of America. Electronic address: David.weinberg@fccc.edu.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Gatsonis', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Zeh', 'Affiliation': 'UT Southwestern, Simmons Cancer Center, Dallas, TX, United States of America.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Carlos', 'Affiliation': 'University of Michigan, Ann Arbor, MI, United States of America.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania-Abramson Cancer Center, Philadelphia, PA, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106144']
2022,32924312,Composite restorations placed in non-carious cervical lesions-Which cavity preparation is clinically reliable?,"The purpose of this in-vivo study was to evaluate the clinical performance of restorations placed in non-carious cervical lesions (NCCLs), using different cavity preparation designs, after 7.7 years. A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin were randomly assigned to the following treatment protocols: dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite. After enamel beveling and selective enamel etching, the defects were restored with composite. The restorations were assessed by two independent, calibrated and blinded investigators, using modified USPHS criteria. At 7 years (7.7 (± 0.35)), a total of 64 restorations (75.3%) were available for follow-up examination. The total retention rate, irrespective of the test groups, was 82.8%. Restorations placed without any preparation showed the highest loss rate (27.8%). Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups. Composites are long-term stable materials for restoring NCCLs. Restorations placed without any dentin preparation (cavity cleaning only) showed the highest loss rate.",2020,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.",['A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin'],"['dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite']","['total retention rate', 'Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration', 'highest loss rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0673997', 'cui_str': 'flowable hybrid composite'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0205250', 'cui_str': 'High'}]",85.0,0.0489112,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.","[{'ForeName': 'Anne-Katrin', 'Initials': 'AK', 'LastName': 'Lührs', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Jacker-Guhr', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hüsamettin', 'Initials': 'H', 'LastName': 'Günay', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Herrmann', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}]",Clinical and experimental dental research,['10.1002/cre2.310']
2023,32929855,Early and maintained application of the secretion of Cryptomphalus aspersa (SCA) 40% improves cutaneous healing after ablative fractional laser in skin aging.,"BACKGROUND


Ablative fractional laser generates a regulated skin damage, which secondarily improves skin aging.
AIMS


The main objective of the present study was to figure out if the adverse effects induced by laser and the skin recovery could improve with the application of a cosmetic product based on the secretion of Cryptomphalus aspersa (SCA).
PATIENTS/METHODS


A prospective double-blind controlled study with vehicle in 10 patients with skin aging. The patients received one session of fractional ablative CO 2   laser, and the formulation with SCA 40% was applied immediately and maintained throughout the 21-day duration of the study. The active treatment (SCA) was applied to one hemifacial area and vehicle to the other, and the patient acting was her own control. Clinical evaluations, dermoscopy, photography, and other parameters like cutaneous hydration, elasticity, and wrinkles were evaluated. In addition, the severity of the adverse effects was evaluated.
RESULTS


Significant greater decrease in the density of microcolumns produced by laser was detected on the active-treated side, indicating greater and faster postprocedure recovery compared to the vehicle-treated side. In addition, side effects were reduced and some antiaging effects were more apparent on the side treated with SCA 40%.
CONCLUSION


SCA 40% applied immediately after ablative laser, and the next day, it can accelerate laser-induced damage regeneration. In addition, SCA improves the cosmetic outcome after laser application.",2020,"RESULTS


Significant greater decrease in the density of microcolumns produced by laser were detected on the active-treated side, indicating greater and faster post-procedure recovery compared to the vehicle-treated side.",['10 patients with skin aging'],"['SCA', 'fractional ablative CO 2  laser and the formulation with SCA']","['cutaneous healing', 'side effects', 'severity of the adverse effects', 'density of microcolumns', 'cosmetic outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",10.0,0.0245539,"RESULTS


Significant greater decrease in the density of microcolumns produced by laser were detected on the active-treated side, indicating greater and faster post-procedure recovery compared to the vehicle-treated side.","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Fernandez-Gonzalez', 'Affiliation': 'Hospital Central de la Defensa, Madrid, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Medical Department of Cantabria labs at Madrid, Madrid, Spain.'}, {'ForeName': 'M Teresa', 'Initials': 'MT', 'LastName': 'Truchuelo', 'Affiliation': 'Vithas Nuestra Señora de América Hospital, Madrid, Spain.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13720']
2024,32925621,Mifepristone Combination Therapy Compared With Misoprostol Monotherapy for the Management of Miscarriage: A Cost-Effectiveness Analysis.,"OBJECTIVE


To assess whether mifepristone pretreatment adversely affects the cost of medical management of miscarriage.
METHODS


Decision tree analyses were constructed, and Monte Carlo simulations were run comparing costs of combination therapy (mifepristone and misoprostol) with monotherapy (misoprostol alone) for medical management of miscarriage in multiple scenarios weighing clinical practice, patient income, and surgical evacuation modalities for failed medical management. Rates of completed medical evacuation for each were obtained from a recent randomized controlled trial.
RESULTS


In every scenario, combination therapy offered a significant cost advantage over monotherapy. Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage. The cost savings associated with combination therapy were greatest in scenarios using a staged approach to misoprostol administration and in scenarios using in-operating room dilation and curettage as the only modality for uterine evacuation, a savings of $190.20 (99% CI 189.35-191.07) and $217.85 (99% CI 217.19-218.50) per patient in a low-income wage group, respectively. A smaller difference was seen in scenarios using in-office manual vacuum aspiration to complete medical management failures. As patients' wages increased, the difference in cost between combination therapy and monotherapy increased.
CONCLUSION


Mifepristone combined with misoprostol is, overall, more cost effective than monotherapy, and therefore cost should not be a deterrent to its adoption in the management of miscarriage.",2020,"Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage.","['medical management of miscarriage in multiple scenarios weighing clinical practice, patient income, and surgical evacuation modalities for failed medical management', 'Miscarriage']","['Mifepristone Combination Therapy', 'Mifepristone', 'mifepristone', 'misoprostol', 'Misoprostol Monotherapy', 'combination therapy (mifepristone and misoprostol) with monotherapy (misoprostol alone']","['cost savings', 'cost of medical management of miscarriage']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.0798285,"Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage.","[{'ForeName': 'Holly H', 'Initials': 'HH', 'LastName': 'Berkley', 'Affiliation': 'Department of Obstetrics & Gynecology at Naval Medical Center San Diego, San Diego, California; and the Uniformed Services University, Bethesda, Maryland.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Greene', 'Affiliation': ''}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wittenberger', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004063']
2025,32925623,Factors Associated With Serum Estradiol Levels Among Postmenopausal Women Using Hormone Therapy.,"OBJECTIVE


To identify factors associated with serum estradiol (E2) levels among healthy postmenopausal women using hormone therapy (HT).
METHODS


This is an unplanned post hoc analysis of data from ELITE (Early versus Late Intervention Trial with Estradiol), a randomized controlled trial of 1 mg oral E2 with or without vaginal progesterone in healthy early compared with late (<6 years compared with 10 or more years since menopause) postmenopausal women. We included results from visits when women reported at least 80% compliance with HT. Mixed-effects linear models identified factors associated with serum E2 levels while participants were taking HT, assessed every 6 months over a median follow-up of 4.8 years and adjusted for baseline E2 level, visit, and reduced E2 dose. Possible correlates evaluated included demographics, clinical characteristics, medication use, and biomarkers of liver and kidney metabolic function.
RESULTS


The analysis included 2,160 E2 measurements in 275 postmenopausal women. Mean±SD age was 55.4±3.9 vs 64.4±5.5 years, and mean±SD time since menopause was 3.6±1.8 vs 16.0±5.6 years for early vs late postmenopausal women. Adjusted for pretreatment E2 level, visit, and reduced dose indicator, higher serum E2 levels were associated with higher body mass index (BMI), higher weight, surgical menopause, alcohol use, and antihypertensive medication use. Current and past smoking and antifungal medication use were associated with lower serum E2 levels. In the multivariable model, higher BMI and alcohol use were associated with higher serum E2 levels, whereas current and past smoking were associated with lower serum E2 levels. These factors were similar between early and late postmenopausal women.
CONCLUSION


Factors associated with serum E2 levels among postmenopausal women taking HT include BMI, alcohol use, and smoking. As serum E2 levels relate to HT effect, achievement of desirable E2 levels may be maximized through personalized intervention.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT00114517.",2020,Current and past smoking and antifungal medication use were associated with lower serum E2 levels.,"['Postmenopausal Women', 'healthy postmenopausal women using hormone therapy (HT', 'healthy early compared with late (<6 years compared with 10 or more years since menopause) postmenopausal women', '275 postmenopausal women', 'Mean±SD age was 55.4±3.9 vs 64.4±5.5 years, and mean±SD time since menopause was 3.6±1.8 vs 16.0±5.6 years for early vs late postmenopausal women']","['oral E2 with or without vaginal progesterone', 'Estradiol']","['body mass index (BMI), higher weight, surgical menopause, alcohol use, and antihypertensive medication use', 'Serum Estradiol Levels', 'serum E2 levels', 'demographics, clinical characteristics, medication use, and biomarkers of liver and kidney metabolic function', 'serum estradiol (E2) levels']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0740421', 'cui_str': 'Postsurgical menopause'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",275.0,0.0428492,Current and past smoking and antifungal medication use were associated with lower serum E2 levels.,"[{'ForeName': 'Intira', 'Initials': 'I', 'LastName': 'Sriprasert', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Thailand; and the Department of Preventive Medicine, the Department of Medicine, the Atherosclerosis Research Unit, and the Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kono', 'Affiliation': ''}, {'ForeName': 'Roksana', 'Initials': 'R', 'LastName': 'Karim', 'Affiliation': ''}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': ''}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shoupe', 'Affiliation': ''}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004006']
2026,32935090,"Patient-Reported Health Outcomes After Treatment of COVID-19 with Nebulized and/or Intravenous Neutral Electrolyzed Saline Combined with Usual Medical Care Versus Usual Medical care alone: A Randomized, Open-Label, Controlled Trial.","Background:  Coronavirus disease (COVID-19) is currently the main public health problem worldwide. The administration of neutral electrolyzed saline, a solution that contains reactive species of chlorine and oxygen (ROS), may be an effective therapeutic alternative due to its immunomodulating characteristics, in systemic inflammation control, as well as in immune response improvement, promoting control of the viral infection. The present study evaluated the efficacy of treatment with intravenous and/or nebulized neutral electrolyzed saline combined with usual medical care  versus  usual medical care alone, in ambulatory patients with COVID-19.  Methods:  A prospective, 2-arm, parallel group, randomized, open-label, phase I-II clinical trial included 39 patients in the control group (usual medical care alone) and 45 patients in the experimental group (usual medical care + intravenous and/or nebulized electrolyzed saline, with dose escalation). Two aspects were evaluated during the twenty-day follow-up: i) the number of patients with disease progression (hospitalization or death); and ii) the Patient Acceptable Symptom State (PASS), a single-question outcome that determines patient well-being thresholds for pain and function. Biochemical and hematologic parameters, as well as adverse effects, were evaluated in the experimental group.  Results:  The experimental treatment decreased the risk for hospitalization by 92% (adjusted RR=0.08, 95% CI: 0.01-0.50, P=0.007), with a 43-fold increase in the probability of achieving an acceptable symptom state on day 5 (adjusted RR= 42.96, 95% CI: 9.22-200.0, P<0.001). Intravenous + nebulized administration was better than nebulized administration alone, but nebulized administration was better than usual medical care alone. Clinical improvement correlated with a decrease in C-reactive protein, and aberrant monocytes and an increase of lymphocytes, and platelets. Cortisol and testosterone levels were also evaluated, observing a decrease in cortisol levels and an increment of testosterone-cortisol ratio, on days 2 and 4.  Conclusions:  The experimental treatment produced no serious adverse effects. In conclusion, intravenous and/or nebulized neutral electrolyzed saline importantly reduced the symptomatology and risk of progression (hospitalization and death), in ambulatory patients with COVID-19.  Trial registration:  Cuban Public Registry of Clinical Trials (RPCEC) Database RPCEC00000309. Registered: 05. May 2020. https://rpcec.sld.cu/en/trials/RPCEC00000309-En.",2020,"Clinical improvement correlated with a decrease in C-reactive protein, and aberrant monocytes and an increase of lymphocytes, and platelets.","['ambulatory patients with COVID-19', '39 patients in the']","['neutral electrolyzed saline, a solution that contains reactive species of chlorine and oxygen (ROS', 'control group (usual medical care alone) and 45 patients in the experimental group (usual medical care + intravenous and/or nebulized electrolyzed saline, with dose escalation', 'intravenous and/or nebulized neutral electrolyzed saline', 'intravenous and/or nebulized neutral electrolyzed saline combined with usual medical care  versus  usual medical care alone', 'COVID-19 with Nebulized and/or Intravenous Neutral Electrolyzed Saline Combined with Usual Medical Care Versus Usual Medical care alone']","['C-reactive protein, and aberrant monocytes and an increase of lymphocytes, and platelets', 'testosterone-cortisol ratio', 'Health Outcomes', 'Cortisol and testosterone levels', 'serious adverse effects', 'symptomatology and risk of progression (hospitalization and death', 'risk for hospitalization', 'cortisol levels', 'number of patients with disease progression (hospitalization or death); and ii) the Patient Acceptable Symptom State (PASS), a single-question outcome that determines patient well-being thresholds for pain and function', 'probability of achieving an acceptable symptom state', 'Biochemical and hematologic parameters']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0008209', 'cui_str': 'Chlorine'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",39.0,0.125275,"Clinical improvement correlated with a decrease in C-reactive protein, and aberrant monocytes and an increase of lymphocytes, and platelets.","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Delgado-Enciso', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Paz-Garcia', 'Affiliation': ''}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Barajas-Saucedo', 'Affiliation': ''}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Mokay-Ramírez', 'Affiliation': ''}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Meza-Robles', 'Affiliation': ''}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Lopez-Flores', 'Affiliation': ''}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Delgado-Machuca', 'Affiliation': ''}, {'ForeName': 'Efren', 'Initials': 'E', 'LastName': 'Murillo-Zamora', 'Affiliation': ''}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Toscano-Velazquez', 'Affiliation': ''}, {'ForeName': 'Josuel', 'Initials': 'J', 'LastName': 'Delgado-Enciso', 'Affiliation': ''}, {'ForeName': 'Valery', 'Initials': 'V', 'LastName': 'Melnikov', 'Affiliation': ''}, {'ForeName': 'Mireya', 'Initials': 'M', 'LastName': 'Walle-Guillen', 'Affiliation': ''}, {'ForeName': 'Hector R', 'Initials': 'HR', 'LastName': 'Galvan-Salazar', 'Affiliation': ''}, {'ForeName': 'Osiris G', 'Initials': 'OG', 'LastName': 'Delgado-Enciso', 'Affiliation': ''}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Cabrera-Licona', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Guzman-Esqu', 'Affiliation': ''}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Montes-Galindo', 'Affiliation': ''}, {'ForeName': 'Alejandra E', 'Initials': 'AE', 'LastName': 'Hernandez-Rangel', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Montes-Diaz', 'Affiliation': ''}, {'ForeName': 'Iram P', 'Initials': 'IP', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': ''}, {'ForeName': 'Margarita L', 'Initials': 'ML', 'LastName': 'Martinez-Fierro', 'Affiliation': ''}, {'ForeName': 'Idalia', 'Initials': 'I', 'LastName': 'Garza-Veloz', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tiburcio-Jimenez', 'Affiliation': ''}, {'ForeName': 'Sergio A', 'Initials': 'SA', 'LastName': 'Zaizar-Fregoso', 'Affiliation': ''}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ramirez-Flores', 'Affiliation': ''}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Gaytan-Sandoval', 'Affiliation': ''}, {'ForeName': 'Carlos R', 'Initials': 'CR', 'LastName': 'Martinez-Perez', 'Affiliation': ''}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Espinoza-Gómez', 'Affiliation': ''}, {'ForeName': 'Fabián', 'Initials': 'F', 'LastName': 'Rojas-Larios', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hirsch-Meillon', 'Affiliation': ''}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Barrios-Navarro', 'Affiliation': ''}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Oviedo-Rodriguez', 'Affiliation': ''}, {'ForeName': 'Luz M Baltazar', 'Initials': 'LMB', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'Brenda A', 'Initials': 'BA', 'LastName': 'Paz-Michel', 'Affiliation': ''}]",Research square,['10.21203/rs.3.rs-68403/v1']
2027,32936872,"Exploring changes in the human gut microbiota and microbial-derived metabolites in response to diets enriched in simple, refined, or unrefined carbohydrate-containing foods: a post hoc analysis of a randomized clinical trial.","BACKGROUND


Dietary carbohydrate type may influence cardiometabolic risk through alterations in the gut microbiome and microbial-derived metabolites, but evidence is limited.
OBJECTIVES


We explored the relative effects of an isocaloric exchange of dietary simple, refined, and unrefined carbohydrate on gut microbiota composition/function, and selected microbial metabolite concentrations.
METHODS


Participants [n = 11; age: 65 ± 8 y; BMI (in kg/m2): 29.8 ± 3.2] were provided with each of 3 diets for 4.5 wk with 2-wk washout, according to a randomized, crossover design. Diets [60% of energy (%E) carbohydrate, 15%E protein, and 25%E fat] differed in type of carbohydrate. Fecal microbial composition, metatranscriptomics, and microbial-derived SCFA and secondary bile acid (SBA) concentrations were assessed at the end of each phase and associated with cardiometabolic risk factors (CMRFs).
RESULTS


Roseburia abundance was higher (11% compared with 5%) and fecal SBA concentrations were lower (lithocolic acid -50% and deoxycholic acid -64%) after consumption of the unrefined carbohydrate diet relative to the simple carbohydrate diet [false discovery rate (FDR): all P < 0.05), whereas Anaerostipes abundance was higher (0.35% compared with 0.12%; FDR: P = 0.04) after the simple carbohydrate diet relative to the refined carbohydrate diet. Metatranscriptomics indicated upregulation of 2 cellular stress genes (FDR: P < 0.1) after the unrefined carbohydrate diet compared with the simple carbohydrate or refined carbohydrate diets. The microbial expression of 3 cellular/oxidative stress and immune response genes was higher (FDR: P < 0.1) after the simple carbohydrate diet relative to the refined carbohydrate diet. No significant diet effect was observed in fecal SCFA concentrations. Independent of diet, we observed 16 associations (all FDR: P < 0.1) of taxon abundance (15 phylum and 1 genera) with serum inflammatory markers and also with fecal SCFA and SBA concentrations.
CONCLUSIONS


Consuming an unrefined carbohydrate-rich diet had a modest effect on the gut microbiome and SBAs, resulting in favorable associations with selected CMRFs. Simple carbohydrate- and refined carbohydrate-rich diets have distinctive effects on the gut microbiome, suggesting differential mechanisms mediate their effects on cardiometabolic health. This trial was registered at clinicaltrials.gov as NCT01610661.",2020,The microbial expression of 3 cellular/oxidative stress and immune response genes was higher (FDR: P < 0.1) after the simple carbohydrate diet relative to the refined carbohydrate diet.,"['11; age: 65\xa0±\xa08 y; BMI (in kg/m2): 29.8\xa0±\xa03.2', 'Participants [n\xa0']","['Simple carbohydrate- and refined carbohydrate-rich diets', 'isocaloric exchange of dietary simple, refined, and unrefined carbohydrate']","['microbial expression of 3 cellular/oxidative stress and immune response genes', 'Roseburia abundance', 'Fecal microbial composition, metatranscriptomics, and microbial-derived SCFA and secondary bile acid (SBA) concentrations', 'Anaerostipes abundance', 'fecal SBA concentrations', 'gut microbiome and SBAs', 'fecal SCFA concentrations']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C4517687', 'cui_str': '3.2'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0175898', 'cui_str': 'Refined carbohydrate'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0086344', 'cui_str': 'Immune response gene'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1224225', 'cui_str': 'Anaerostipes'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.0400471,The microbial expression of 3 cellular/oxidative stress and immune response genes was higher (FDR: P < 0.1) after the simple carbohydrate diet relative to the refined carbohydrate diet.,"[{'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Faits', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Maura E', 'Initials': 'ME', 'LastName': 'Walker', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Rodriguez-Morato', 'Affiliation': 'Pompeu Fabra University, Barcelona, Spain.'}, {'ForeName': 'Huicui', 'Initials': 'H', 'LastName': 'Meng', 'Affiliation': 'Cardiovascular Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Gervis', 'Affiliation': 'Cardiovascular Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Galluccio', 'Affiliation': 'Cardiovascular Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Alice H', 'Initials': 'AH', 'LastName': 'Lichtenstein', 'Affiliation': 'Cardiovascular Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'W Evan', 'Initials': 'WE', 'LastName': 'Johnson', 'Affiliation': 'Division of Computational Biomedicine, Department of Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Nirupa R', 'Initials': 'NR', 'LastName': 'Matthan', 'Affiliation': 'Cardiovascular Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa254']
2028,32937273,"Short-term and long-term effects of ankle joint taping and bandaging on balance, proprioception and vertical jump among volleyball players with chronic ankle instability.","OBJECTIVE


This study hypothesized that the prolonged use of taping during athletic activities produces more significant increases in proprioception, balance, and vertical jump among volleyball players with CAI.
DESIGN


A randomized controlled study.
PARTICIPANTS


One-hundred participants with chronic ankle instability (CAI) participated in this study. Participants were distributed into 3-groups: taping group, bandaging group, and control group.
PRIMARY OUTCOME MEASURES


Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester).
INTERVENTIONS


Three interventions were performed: ankle rigid taping, ankle bandaging, and placebo taping. The measurements were performed at baseline, immediately, 2-weeks and 2-months after support.
RESULTS


Immediately after supports, there were non-significant differences between all groups for proprioception, balance (P < .05). There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P < .05). After 2-weeks and 2-months, there were significant differences between bandaging and control groups, and taping and control groups for proprioception, balance, and vertical jump (P < .05). There were non-significant differences between taping and bandaging groups (P < .05) during all assessments.
CONCLUSION


This study indicated that ankle taping and bandaging immediately improve vertical jump only; while they improve proprioception, balance, and vertical jump after 2-weeks and 2-months.",2020,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","['One-hundred participants with chronic ankle instability (CAI) participated in this study', 'volleyball players with CAI', 'volleyball players with chronic ankle instability']","['ankle joint taping and bandaging', 'taping group, bandaging group, and control group', 'ankle rigid taping, ankle bandaging, and placebo taping']","['proprioception, balance, and vertical jump', 'proprioception, balance, and vertical jump (P', 'Proprioception (ankle range of motion absolute error), balance(Y-balance test), and vertical jump (vertical jump tester', 'proprioception, balance', 'balance, proprioception and vertical jump']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0183885', 'cui_str': 'Tester'}]",100.0,0.0294532,"There was a significant difference between banding and control groups, and taping and control groups for the vertical jump (P ","[{'ForeName': 'Motaz', 'Initials': 'M', 'LastName': 'Alawna', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey. Electronic address: malawna@gelisim.edu.tr.'}, {'ForeName': 'Ayman A', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, School of Health Sciences, Istanbul Gelisim University, Istanbul, Turkey. Electronic address: amohamed@gelisim.edu.tr.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.015']
2029,32938633,Opportunistic screening versus usual care for detection of atrial fibrillation in primary care: cluster randomised controlled trial.,"OBJECTIVE


To investigate whether opportunistic screening in primary care increases the detection of atrial fibrillation compared with usual care.
DESIGN


Cluster randomised controlled trial.
SETTING


47 intention-to-screen and 49 usual care primary care practices in the Netherlands, not blinded for allocation; the study was carried out from September 2015 to August 2018.
PARTICIPANTS


In each practice, a fixed sample of 200 eligible patients, aged 65 or older, with no known history of atrial fibrillation in the electronic medical record system, were randomly selected. In the intention-to-screen group, 9218 patients eligible for screening were included, 55.0% women, mean age 75.2 years. In the usual care group, 9526 patients were eligible for screening, 54.3% women, mean age 75.0 years.
INTERVENTIONS


Opportunistic screening (that is, screening in patients visiting their general practice) consisted of three index tests: pulse palpation, electronic blood pressure measurement with an atrial fibrillation algorithm, and electrocardiography (ECG) with a handheld single lead electrocardiographic device. The reference standard was 12 lead ECG, performed in patients with at least one positive index test and in a sample of patients (10%) with three negative tests. If 12 lead ECG showed no atrial fibrillation, patients were invited for more screening by continuous monitoring with a Holter electrocardiograph for two weeks.
MAIN OUTCOME MEASURES


Difference in the detection rate of newly diagnosed atrial fibrillation over one year in intention-to-screen versus usual care practices.
RESULTS


Follow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices. 144 (1.62%) new diagnoses of atrial fibrillation in the intention-to-screen group versus 139 (1.53%) in the usual care group were found (adjusted odds ratio 1.06 (95% confidence interval 0.84 to 1.35)). Of 9218 eligible patients in the intention-to-screen group, 4106 (44.5%) participated in the screening protocol. In these patients, 12 lead ECG detected newly diagnosed atrial fibrillation in 26 patients (0.63%). In the 266 patients who continued with Holter monitoring, four more diagnoses of atrial fibrillation were found.
CONCLUSIONS


Opportunistic screening for atrial fibrillation in primary care patients, aged 65 and over, did not increase the detection rate of atrial fibrillation, which implies that opportunistic screening for atrial fibrillation is not useful in this setting.
TRIAL REGISTRATION


Netherlands Trial Register No NL4776 (old NTR4914).",2020,"RESULTS


Follow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices.","['9218 patients eligible for screening were included, 55.0% women, mean age 75.2 years', '9526 patients were eligible for screening, 54.3% women, mean age 75.0 years', '47 intention-to-screen and 49 usual care primary care practices in the Netherlands, not blinded for allocation; the study was carried out from September 2015 to August 2018', '8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices', '266 patients who continued with Holter monitoring', 'In each practice, a fixed sample of 200 eligible patients, aged 65 or older, with no known history of atrial fibrillation in the electronic medical record system, were randomly selected', '9218 eligible patients in the intention-to-screen group, 4106 (44.5%) participated in the screening protocol']","['Opportunistic screening versus usual care', 'three index tests: pulse palpation, electronic blood pressure measurement with an atrial fibrillation algorithm, and electrocardiography (ECG) with a handheld single lead electrocardiographic device', 'Opportunistic screening']","['diagnosed atrial fibrillation', 'atrial fibrillation', 'diagnoses of atrial fibrillation', 'detection rate of newly diagnosed atrial fibrillation', 'detection rate of atrial fibrillation', 'new diagnoses of atrial fibrillation', 'detection of atrial fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0729790', 'cui_str': 'H/O: atrial fibrillation'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0422389', 'cui_str': 'Opportunistic screening'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}]",9526.0,0.151619,"RESULTS


Follow-up was complete for 8874 patients in the intention-to-screen practices and for 9102 patients in the usual care practices.","[{'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Uittenbogaart', 'Affiliation': 'Department of General Practice, Amsterdam Public Health, Amsterdam University Medical Centers, University of Amsterdam, 9 Meibergdreef, PO Box 22660, 1100 DD Amsterdam, Netherlands s.b.uittenbogaart@amsterdamumc.nl.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Verbiest-van Gurp', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Netherlands.'}, {'ForeName': 'Wim A M', 'Initials': 'WAM', 'LastName': 'Lucassen', 'Affiliation': 'Department of General Practice, Amsterdam Public Health, Amsterdam University Medical Centers, University of Amsterdam, 9 Meibergdreef, PO Box 22660, 1100 DD Amsterdam, Netherlands.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nielen', 'Affiliation': 'Netherlands Institute for Health Services Research, Utrecht, Netherlands.'}, {'ForeName': 'Petra M G', 'Initials': 'PMG', 'LastName': 'Erkens', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Netherlands.'}, {'ForeName': 'J André', 'Initials': 'JA', 'LastName': 'Knottnerus', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Netherlands.'}, {'ForeName': 'Henk C P M', 'Initials': 'HCPM', 'LastName': 'van Weert', 'Affiliation': 'Department of General Practice, Amsterdam Public Health, Amsterdam University Medical Centers, University of Amsterdam, 9 Meibergdreef, PO Box 22660, 1100 DD Amsterdam, Netherlands.'}, {'ForeName': 'Henri E J H', 'Initials': 'HEJH', 'LastName': 'Stoffers', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute, Faculty of Health, Medicine, and Life Sciences, Maastricht University, Netherlands.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m3208']
2030,32919407,The effects of eszopiclone on sleep spindles and memory consolidation in schizophrenia: a randomized clinical trial.,"Sleep spindles, defining oscillations of stage 2 non-rapid eye movement sleep (N2), mediate memory consolidation. Schizophrenia is characterized by reduced spindle activity that correlates with impaired sleep-dependent memory consolidation. In a small, randomized, placebo-controlled pilot study of schizophrenia, eszopiclone (Lunesta®), a nonbenzodiazepine sedative hypnotic, increased N2 spindle density (number/minute) but did not significantly improve memory. This larger double-blind crossover study that included healthy controls investigated whether eszopiclone could both increase N2 spindle density and improve memory. Twenty-six medicated schizophrenia outpatients and 29 healthy controls were randomly assigned to have a placebo or eszopiclone (3 mg) sleep visit first. Each visit involved two consecutive nights of high density PSG with training on the Motor Sequence Task (MST) on the second night and testing the following morning. Patients showed a widespread reduction of spindle density and, in both groups, eszopiclone increased spindle density but failed to enhance sleep-dependent procedural memory consolidation. Follow-up analyses revealed that eszopiclone also affected cortical slow oscillations: it decreased their amplitude, increased their duration, and rendered their phase locking with spindles more variable. Regardless of group or visit, the density of coupled spindle-slow oscillation events predicted memory consolidation significantly better than spindle density alone, suggesting that they are a better biomarker of memory consolidation. In conclusion, sleep oscillations are promising targets for improving memory consolidation in schizophrenia, but enhancing spindles is not enough. Effective therapies also need to preserve or enhance cortical slow oscillations and their coordination with thalamic spindles, an interregional dialog that is necessary for sleep-dependent memory consolidation.Fig. 1FINGER TAPPING MOTOR SEQUENCE TASK (MST) ADMINISTRATION AND RESULTS.: a Participants, randomized to the placebo or eszopiclone visit first, had an introductory/screening visit and two sleep visits, a week apart. Sleep visits involved polysomnography on two consecutive nights (Baseline, MST). Different MST sequences were employed for the two sleep visits and their order was counterbalanced within groups. There is no transfer of learning between MST sequences [83]. Participants trained on the MST before bedtime of the second night and were tested in the morning. Ten minutes after testing, participants trained on a new ""control"" sequence to evaluate the possibility of eszopiclone ""hangover"" effects on MST performance. Prior to each MST administration, participants completed the Stanford Sleepiness Scale (SSS) to measure subjective alertness [84]. b The MST requires participants to repeatedly type a five-digit sequence (e.g., 4-1-3-2-4) on a numerically labeled keyboard with the left hand, ""as quickly and accurately as possible"" for twelve 30 s trials separated by 30 s rest periods. The sequence is displayed at the top of the screen and dots appear beneath it with each keystroke. Participants train before sleep and test on an additional 12 trials after sleep. c Bar graphs of group differences in overnight MST improvement on placebo and eszopiclone with SE bars. Asterisk denotes p < 0.05. d Spindle density at electrode location Cz (inset) on the MST night plotted against overnight MST improvement by group for the placebo and e eszopiclone visits. f Density of spindle-SO events on the MST nights plotted against overnight MST improvement, averaged over the placebo and eszopiclone visits, in the cluster showing a significant correlation (inset). The regression line for the combined groups and visits is shown.Fig. 2ESZOPICLONE EFFECTS ON N2 SLEEP SPINDLE DENSITY.: a Topographical maps of spindle density averaged across nights of the placebo and eszopiclone visits for each group and the comparison of the two visits. Electrodes with a cluster-corrected p < 0.05 are highlighted in green. b Group difference maps (top and middle rows) show significantly greater spindle density in controls than patients on placebo (two significant clusters), but not eszopiclone. Electrodes highlighted in black correspond to p uncorrected  < 0.05. Bottom row: Group by Drug interaction showing electrodes where the eszopiclone effect of increasing spindle density was nonsignificantly greater in patients (p uncorrected  < 0.05). c Top: main effect of Group on spindle density showing a significant cluster. Middle: bar graph of spindle density averaged across the electrodes in the significant cluster with SE bars. Bottom: Drug main effect-eszopiclone increased spindle density at all electrodes.Fig. 3ESZOPICLONE EFFECTS ON N2 SOS AND THEIR COORDINATION WITH SPINDLES.: a Topographical maps of mean SO phase at spindle peak during the placebo and eszopiclone visits (averaged across groups and nights) and a statistical map of their difference. Electrodes highlighted in black meet a threshold of p uncorrected  < 0.05. Circular plots show SO phase at Cz. Lines represent the mean SO phase for each participant and their length represents the consistency of the spindle-SO phase locking. Arrows represent the group means. Right column: mapping of SO phase to topographical maps and circular plots. b Topographical maps of SO and spindle-SO coordination parameters during the placebo and eszopiclone visits and statistical maps of their difference. Electrodes with a cluster-corrected p < 0.05 are highlighted in green. c Plot of the relation of SO amplitude with spindle-SO phase consistency, averaged over the placebo and eszopiclone visits, in the cluster showing a significant correlation (inset shows significant cluster). Regression line is for the combined groups and drug visits.",2020,"Regardless of group or visit, the density of coupled spindle-slow oscillation events predicted memory consolidation significantly better than spindle density alone, suggesting that they are a better biomarker of memory consolidation.","['Twenty-six medicated schizophrenia outpatients and 29 healthy controls', 'Bottom', 'schizophrenia']","['MST', 'placebo or eszopiclone', 'placebo', 'eszopiclone', 'schizophrenia, eszopiclone (Lunesta®']","['N2 spindle density and improve memory', 'cortical slow oscillations', 'Sleep visits involved polysomnography', 'overnight MST improvement', 'sleep spindles and memory consolidation', 'Stanford Sleepiness Scale (SSS', 'spindle density', 'MST night plotted against overnight MST improvement']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1436328', 'cui_str': 'Eszopiclone'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1579761', 'cui_str': 'Lunesta'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",,0.0911188,"Regardless of group or visit, the density of coupled spindle-slow oscillation events predicted memory consolidation significantly better than spindle density alone, suggesting that they are a better biomarker of memory consolidation.","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Mylonas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Bengi', 'Initials': 'B', 'LastName': 'Baran', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Demanuele', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Cox', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Tessa C', 'Initials': 'TC', 'LastName': 'Vuper', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Seicol', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Correll', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Parr', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Cameron E', 'Initials': 'CE', 'LastName': 'Callahan', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Vangel', 'Affiliation': 'Department of Biostatistics, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stickgold', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Dara S', 'Initials': 'DS', 'LastName': 'Manoach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. dara.manoach@mgh.harvard.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00833-2']
2031,32920297,Postprandial factor VII activation does not increase plasma concentrations of prothrombin fragment 1 + 2 in patients with morbid obesity.,"INTRODUCTION


Increased postprandial factor VII activation is observed after high-fat meals, but is not accompanied by thrombin formation in normal weight individuals. Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals. We therefore compared postprandial effects of high-fat meals and low-fat meals on biomarkers of coagulation activation in patients with morbid obesity and investigated whether the response was associated with the gut bacteria composition.
MATERIALS AND METHODS


A controlled cross-over study was conducted in obese patients (15 women, 5 men, mean BMI = 44.1 kg/m 2 ), where high-fat meals (67 E% fat) and low-fat meals (16 E% fat) were served at 8:15 and 10:00 in a random order on two study days within one week. Blood samples were collected at 08:00 (fasting), 12:00, and 14:00 and analysed for triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1 + 2 (F1+2), and TF pathway inhibitor (TFPI). The gut bacteria composition, measured as gram-negative bacteria and diversity, was analysed in faecal samples.
RESULTS


Triglycerides, FVIIa, and FVIIa-AT increased significantly after high-fat meals, whereas F1 + 2 decreased equally and significantly over time after both meals. There were no significant changes in TF and TFPI over time. The postprandial changes in F1 + 2 and TFPI after high-fat meals were negatively correlated with diversity.
CONCLUSIONS


Increased postprandial FVIIa is not accompanied by thrombin formation four hours after high-fat meals in patients with morbid obesity, possibly due to FVIIa-inhibition by AT.",2020,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","['patients with morbid obesity', 'obese patients (15 women, 5 men, mean BMI\xa0', 'normal weight individuals']",['high-fat meals and low-fat meals'],"['Triglycerides, FVIIa, and FVIIa-AT', 'triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1\xa0+\xa02 (F1+2), and TF pathway inhibitor (TFPI', 'Blood samples', 'postprandial changes', 'gut bacteria composition', 'TF and TFPI', 'thrombin formation', 'circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0072436', 'cui_str': 'Prothrombin fragment 1.2'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",,0.0190304,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","[{'ForeName': 'Line Espenhain', 'Initials': 'LE', 'LastName': 'Landgrebe', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark; OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark. Electronic address: Line.Espenhain.Landgrebe@rsyd.dk.'}, {'ForeName': 'Claus Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Department of Medicine, Section of Endocrinology, University Hospital of Southern Denmark, Esbjerg, Denmark; Steno Diabetes Center Odense, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Focused Research Unit for Molecular Diagnostic and Clinical Research, University Hospital of Southern Denmark, Aabenraa, Denmark; Institute of Molecular Medicine, University of Southern Denmark, Denmark.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Moitinho-Silva', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany; Department of Dermatology, Venereology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bang', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany.'}, {'ForeName': 'Else Marie', 'Initials': 'EM', 'LastName': 'Bladbjerg', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.08.044']
2032,32920321,Effects of cerebellar transcranial magnetic stimulation on ataxias: A randomized trial.,"INTRODUCTION


Cerebellar ataxia remains a neurological symptom orphan of treatment interventions, despite being prevalent and incapacitating. We aimed to study, in a double-blind design, whether cerebellar modulation could improve ataxia.
METHODS


We included patients with diagnosis of spinocerebellar ataxia type 3, multiple systems atrophy cerebellar type, or post-lesion ataxia. Patients received five sessions each of sham and active cerebellar 1 Hz deep repetitive transcranial magnetic stimulation in randomized order. Our primary outcome was the decrease in the Scale for the Assessment and Rating of Ataxia when comparing phases (active x sham). Secondary outcomes measures included the International Cooperative Ataxia Rating Scale, and other motor, cognitive, and quality of life scales. This study was registered at clinicaltrials.gov (protocol NCT03213106).
RESULTS


Twenty-four patients aged 29-74 years were included in our trial. After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002]. The International Cooperative Ataxia Rating Scale score also improved after active stimulation versus sham [median (interquartile range) of 29.0 (21.0, 43.5) versus 32.8 (22.0, 47.0); p = 0.005]. Other secondary outcomes were not significantly modified by stimulation. No patient presented severe side effects, and nine presented mild and self-limited symptoms.
CONCLUSIONS


Our protocol was safe and well-tolerated. These findings suggest that cerebellar modulation may improve ataxic symptom and provide reassurance about safety for clinical practice.",2020,"After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002].","['ataxias', 'Twenty-four patients aged 29-74 years', 'patients with diagnosis of spinocerebellar ataxia type 3, multiple systems atrophy cerebellar type, or post-lesion ataxia']","['Hz deep repetitive transcranial magnetic stimulation', 'cerebellar transcranial magnetic stimulation']","['International Cooperative Ataxia Rating Scale score', 'ataxia', 'ataxic symptom', 'severe side effects', 'International Cooperative Ataxia Rating Scale, and other motor, cognitive, and quality of life scales', 'safe and well-tolerated', 'Scale for the Assessment and Rating of Ataxia', 'Scale for the Assessment and Rating of Ataxia score']","[{'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024408', 'cui_str': 'Azorean disease'}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C4760996', 'cui_str': 'International cooperative ataxia rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0234366', 'cui_str': 'Ataxic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C4760258', 'cui_str': 'Ataxia assessment scale'}]",24.0,0.653213,"After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002].","[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'França', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'de Andrade', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Valquíria', 'Initials': 'V', 'LastName': 'Silva', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Galhardoni', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manoel J', 'Initials': 'MJ', 'LastName': 'Teixeira', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil; Functional Neurosurgery Division, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rubens G', 'Initials': 'RG', 'LastName': 'Cury', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil; Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil. Electronic address: rubens_cury@usp.br.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.09.001']
2033,32920476,A brief cognitive behavioural intervention is cost-effective for primary care patients with medically unexplained physical symptoms compared to usual care.,"OBJECTIVE


To assess the cost-effectiveness of a brief cognitive behavioural intervention for patients with medically unexplained physical symptoms (MUPS) provided by a mental health nurse practitioner (MHNP) in primary care in comparison with usual care.
METHODS


We performed an economic evaluation from a societal perspective alongside a cluster randomised controlled trial with 12 months follow-up. The primary outcome was quality-adjusted life-years (QALYs). Secondary outcomes were the RAND-36 physical component summary score (PCS), somatic symptom severity (Patient Health Questionnaire (PHQ-15), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale (HADS)). Missing data were imputed using multiple imputation. We used non-parametric bootstrapping to estimate statistical uncertainty. The bootstrapped cost-effect pairs were used to estimate cost-effectiveness planes and cost-effectiveness acceptability curves.
RESULTS


Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134). The mean difference in QALYs was 0.01 (95% CI -0.01 to 0.04), in PCS 2.46 (95% CI 1.44 to 3.47), in PHQ-15 -0.26 (95% CI -0.81 to 0.28), and in HADS -0.07 (-0.81 to 0.67). At a willingness to pay of 0 € per additional unit of effect, the probability of the intervention being cost-effective was 0.93 for QALYs and 0.92 for PCS, PHQ-15 and HADS scores.
CONCLUSION


Our intervention is cost-effective compared to usual care for patients with MUPS. Implementation of the intervention has the potential to result in a significant decline in costs. However, large scale implementation would require increased deployment of MHNPs.",2020,"Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134).","['patients with MUPS', 'patients with medically unexplained physical symptoms (MUPS) provided by a mental health nurse practitioner (MHNP) in primary care in comparison with usual care', 'primary care patients with medically unexplained physical symptoms compared to usual care']",['cognitive behavioural intervention'],"['cost-effectiveness', 'quality-adjusted life-years (QALYs', 'RAND-36 physical component summary score (PCS), somatic symptom severity (Patient Health Questionnaire (PHQ-15), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale (HADS', 'cost-effectiveness planes and cost-effectiveness acceptability curves', 'Mean total costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.101801,"Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Sitnikova', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands. Electronic address: e.sitnikova@amsterdamumc.nl.'}, {'ForeName': 'Aureliano P', 'Initials': 'AP', 'LastName': 'Finch', 'Affiliation': 'EuroQol Research Foundation, Marten Meesweg 107, 3068 AV Rotterdam, the Netherlands.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Leone', 'Affiliation': 'Trimbos Institute, Da Costakade 45, 3521 VS Utrecht, the Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Vrije Universiteit Amsterdam, De Boelelaan 1105, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'Harm W J', 'Initials': 'HWJ', 'LastName': 'van Marwijk', 'Affiliation': 'Brighton and Sussex Medical School, 94 N - S Rd, Falmer, Brighton BN1 9PX, United Kingdom.'}, {'ForeName': 'Henriëtte E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110217']
2034,32920492,A randomized-controlled trial of blonanserin and olanzapine as adjunct to antipsychotics in the treatment of patients with schizophrenia and dopamine supersensitivity psychosis: The ROADS study.,"Dopamine supersensitivity psychosis (DSP) is a key factor contributing to the development of antipsychotic treatment-resistant schizophrenia. We examined the efficacy and safety of blonanserin (BNS) and olanzapine (OLZ) as adjuncts to prior antipsychotic treatment in patients with schizophrenia and DSP in a 24-week, multicenter (17 sites), randomized, rater-blinded study with two parallel groups (BNS and OLZ add-on treatments) in patients with schizophrenia and DSP: the ROADS Study. The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 24. Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses. The 61 assessed patients were allocated into a BNS group (n = 26) and an OLZ group (n = 29). The PANSS total scores were reduced in both groups (mean ± SD: -14.8 ± 24.0, p = 0.0042; -10.5 ± 12.9, p = 0.0003; respectively) with no significant between-group difference (mean, -4.3, 95 %CI 15.1-6.4, p = 0.42). The BNS group showed significant reductions from week 4; the OLZ group showed significant reductions from week 8. The ESRS scores were reduced in the BNS group and the others were reduced in both groups. The antipsychotic monotherapy rates at the endpoint were 26.3 % (n = 6) for BNS and 23.8 % (n = 5) for OLZ. The concomitant antipsychotic doses were reduced in both groups with good tolerability. Our results suggest that augmentations with BNS and OLZ are antipsychotic treatment options for DSP patients, and BNS may be favorable for DSP based on the relatively quick responses to BNS observed herein.",2020,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","['patients with schizophrenia and dopamine supersensitivity psychosis', 'Dopamine supersensitivity psychosis (DSP', 'patients with schizophrenia and DSP in a 24-week, multicenter (17 sites', 'patients with schizophrenia and DSP']","['BNS', 'OLZ', 'antipsychotics', 'blonanserin (BNS) and olanzapine (OLZ', 'blonanserin and olanzapine']","['PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses', 'antipsychotic monotherapy rates', 'change in the Positive and Negative Syndrome Scale (PANSS) total score', 'ESRS scores', 'PANSS total scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0187611,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","[{'ForeName': 'Tomihisa', 'Initials': 'T', 'LastName': 'Niitsu', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan. Electronic address: niitsu@chiba-u.jp.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Hata', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Fujita Hospital, Sosa, Chiba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': 'Soshu Hospital, Atsugi, Kanagawa, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Hosoda', 'Affiliation': 'Fujita Hospital, Sosa, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Seki', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Chiba Hospital, Funabashi, Chiba, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Okehazama Hospital Fujita Kokoro Care Center, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Asai Hospital, Togane, Chiba, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Kisatazu Hospital, Kisarazu, Chiba, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Katsushikabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Johmoh Hospital, Maebashi, Gunma, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Sanmaibashi Hospital, Ota, Gunma, Japan.'}, {'ForeName': 'Yukitsugu', 'Initials': 'Y', 'LastName': 'Imamura', 'Affiliation': 'Department of Neuropsychiatry, Asahi General Hospital, Asahi, Chiba, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Yowa Hospital, Tokyo, Japan; Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Fukami', 'Affiliation': 'Chiba Psychiatric Medical Center, Chiba, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Project Leader Office, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Sodegaura-Satsukidai Hospital, Sodegaura, Chiba, Japan.'}, {'ForeName': 'Masatomo', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiina', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Kanahara', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Iyo', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102369']
2035,32924256,Evaluation of intralesional Candida antigen in diabetic patients with multiple warts.,"BACKGROUND


Treatment of warts in diabetic patients with ablative modalities poses a significant risk owing to increased possibility of secondary infection, slow healing, and recurrence. Intralesional immunotherapy has gained popularity in the treatment of warts due to its proven efficacy and good tolerability compared with destructive methods.
AIM


To evaluate the intralesional Candida antigen injection for the treatment of multiple warts in diabetic patients.
PATIENTS/METHODS


Fifty diabetic patients with multiple genital/nongenital warts were divided into two groups. The first group (30 patients) received intralesional Candida antigen, and the second group (20 patients) had intralesional saline as control. The treatments were injected into the largest wart every 2 weeks until complete clearance of warts or for a maximum of five sessions.
RESULTS


Complete clearance of warts was observed in 80% of the diabetic patients in the Candida antigen group compared with 15% in the control group (P < .001). Side effects to Candida antigen included pain during injection in all patients, flu-like symptoms, and localized reaction at the injection site in few patients.
CONCLUSION


Intralesional Candida antigen injection can be a promising effective and safe therapeutic option for the treatment of warts in diabetic patients.",2020,"Side effects to Candida antigen included pain during injection in all patients, flu-like symptoms and localized reaction at the injection site in few patients.
","['warts in diabetic patients', 'multiple warts in diabetic patients', 'Fifty diabetic patients with multiple genital / non-genital warts', 'diabetic patients', 'diabetic patients with multiple warts']","['intralesional Candida antigen injection', 'intralesional Candida antigen', 'Intralesional Candida antigen injection', 'Intralesional immunotherapy', 'intralesional saline']","['pain', 'Complete clearance of warts']","[{'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0856325', 'cui_str': 'Non-genital warts NOS'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0006836', 'cui_str': 'Candida'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}]",50.0,0.0194649,"Side effects to Candida antigen included pain during injection in all patients, flu-like symptoms and localized reaction at the injection site in few patients.
","[{'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Marei', 'Affiliation': 'Microbiology and Immunology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Alakad', 'Affiliation': 'Interventional Research Lab, Interventional Immunology and Allergy Center, Zagazig, Egypt.'}, {'ForeName': 'Reham M', 'Initials': 'RM', 'LastName': 'Wahid', 'Affiliation': 'Physiology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13718']
2036,32920065,DNA methylation of hypertension-related genes and effect of riboflavin supplementation in adults stratified by genotype for the MTHFR C677T polymorphism.,"BACKGROUND


The interaction between genetic, epigenetic and environmental factors plays an important role in the aetiology of hypertension. GWAS and observational studies link the C677T polymorphism in methylenetetrahydrofolate reductase (MTHFR) with hypertension, while riboflavin, the MTHFR cofactor, has been shown to reduce blood pressure and global DNA methylation in homozygous (TT genotype) individuals. It is currently unclear whether riboflavin modulates DNA methylation of other hypertension-related genes.
OBJECTIVES


To compare DNA methylation of hypertension-related genes in adults stratified by MTHFR genotype and effect of riboflavin intervention in adults with the variant MTHFR 677TT genotype.
METHOD


Pyrosequencing was carried out for hypertension-related genes (ACE, AGTR1, GCK, GNA12, IGF2, MMP9 and NOS3) in blood samples from participants in previous trials (CC, n = 40; TT, n = 40). The effect of intervention with riboflavin (1.6 mg/d for16 weeks) or placebo on DNA methylation was investigated in adults with the variant MTHFR 677TT genotype (n = 80).
RESULTS


Individuals with the MTHFR 677TT v CC genotype had significantly higher average DNA methylation at NOS3 (+1.66%, P = 0.044). In response to riboflavin supplementation in TT individuals, there was an increase in average DNA methylation at IGF2 (+1.09%, P = 0.019) and a decrease at ACE (-0.44%, P = 0.021) in females only. Specific CpG sites were hypomethylated in GNA12 and hypermethylated in AGTR1.
CONCLUSION


This study provides the first RCT evidence that riboflavin alters DNA methylation of hypertension-related genes in adults with the MTHFR 677TT genotype, providing some insight into mechanisms linking hypertension with the genotype-specific response of BP to riboflavin.",2020,"Specific CpG sites were hypomethylated in GNA12 and hypermethylated in AGTR1.
","['homozygous (TT genotype) individuals', 'adults with the variant MTHFR 677TT genotype', 'adults with the MTHFR 677TT genotype', 'adults with the variant MTHFR 677TT genotype (n\u202f=\u202f80']","['riboflavin', 'placebo', 'riboflavin intervention', 'riboflavin supplementation']","['blood pressure and global DNA methylation', 'DNA methylation', 'average DNA methylation at IGF2', 'average DNA methylation at NOS3']","[{'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0066357', 'cui_str': 'Methylenetetrahydrofolate reductase (NADPH)'}]","[{'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4524020', 'cui_str': 'Riboflavin supplementation'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C1569730', 'cui_str': 'insulin-like growth factor 2, human'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}]",,0.0498317,"Specific CpG sites were hypomethylated in GNA12 and hypermethylated in AGTR1.
","[{'ForeName': 'Sophia D', 'Initials': 'SD', 'LastName': 'Amenyah', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine, N. Ireland, UK. BT52 1SA, UK; Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, N. Ireland, UK. BT52 1SA, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ward', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, N. Ireland, UK. BT52 1SA, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McMahon', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, N. Ireland, UK. BT52 1SA, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Deane', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine, N. Ireland, UK. BT52 1SA, UK.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'McNulty', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, N. Ireland, UK. BT52 1SA, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, N. Ireland, UK. BT52 1SA, UK.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Strain', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, N. Ireland, UK. BT52 1SA, UK.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Horigan', 'Affiliation': 'Nutrition Innovation Centre for Food and Health (NICHE), Ulster University, Coleraine, N. Ireland, UK. BT52 1SA, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Purvis', 'Affiliation': 'Department of Cardiology, Altnagelvin Area Hospital, N. Ireland, UK. BT47 6SB, UK.'}, {'ForeName': 'Colum P', 'Initials': 'CP', 'LastName': 'Walsh', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine, N. Ireland, UK. BT52 1SA, UK.'}, {'ForeName': 'Diane J', 'Initials': 'DJ', 'LastName': 'Lees-Murdock', 'Affiliation': 'Genomic Medicine Research Group, Ulster University, Coleraine, N. Ireland, UK. BT52 1SA, UK. Electronic address: dj.lees@ulster.ac.uk.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.09.011']
2037,32930386,Overdiagnosis in lung cancer screening: Estimates from the German Lung Cancer Screening Intervention Trial.,"Overdiagnosis is a major potential harm of lung cancer screening; knowing its potential magnitude helps to optimize screening eligibility criteria. The German Lung Screening Intervention Trial (""LUSI"") is a randomized trial among 4052 long-term smokers (2622 men), 50.3 to 71.9 years of age from the general population around Heidelberg, Germany, comparing five annual rounds of low-dose computed tomography (n = 2029) with a control arm without intervention (n = 2023). After a median follow-up of 9.77 years postrandomization and 5.73 years since last screening, 74 participants were diagnosed with lung cancer in the control arm and 90 in the screening arm: 69 during the active screening period; of which 63 screen-detected and 6 interval cancers. The excess cumulative incidence in the screening arm (N = 16) represented 25.4% (95% confidence interval: -11.3, 64.3] of screen-detected cancer cases (N = 63). Analyzed by histologic subtype, excess incidence in the screening arm appeared largely driven by adenocarcinomas. Statistical modeling yielded an estimated mean preclinical sojourn time (MPST) of 5.38 (4.76, 5.88) years and a screen-test sensitivity of 81.6 (74.4%, 88.8%) for lung cancer overall, all histologic subtypes combined. Based on modeling, we further estimated that about 48% (47.5% [43.2%, 50.7%]) of screen-detected tumors have a lead time ≥4 years, whereas about 33% (32.8% [28.4%, 36.1%]) have a lead time ≥6 years, 23% (22.6% [18.6%, 25.7%]) ≥8 years, 16% (15.6% [12.2%, 18.3%]) ≥10 years and 11% (10.7% [8.0%, 13.0%]) ≥12 years. The high proportions of tumors with relatively long lead times suggest a major risk of overdiagnosis for individuals with comparatively short remaining life expectancies.",2020,"The excess cumulative incidence in the screening arm (N=16) represented 25.4% [95%CI -11.3, 64.3] of screen-detected cancer cases (N=63).","['74 participants were diagnosed with lung cancer in the control arm and 90 in the screening arm: 69 during the active screening period; of which 63 screen-detected and 6 interval cancers', '4052 long-term smokers (2622 men), 50.3-71.9\u2009years of age from the general population around Heidelberg, Germany, comparing five annual rounds of low-dose computed tomography (n=2029) with a control arm without intervention (n=2023']",[],"['excess cumulative incidence', 'mean pre-clinical sojourn time (MPST']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C2919572', 'cui_str': 'Malignant neoplasm detection during interval between recommended screening examinations'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1964473', 'cui_str': 'Sojourn'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",4052.0,0.109361,"The excess cumulative incidence in the screening arm (N=16) represented 25.4% [95%CI -11.3, 64.3] of screen-detected cancer cases (N=63).","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'González Maldonado', 'Affiliation': 'Division of Cancer Epidemiology (C020), German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Erna', 'Initials': 'E', 'LastName': 'Motsch', 'Affiliation': 'Division of Cancer Epidemiology (C020), German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Trotter', 'Affiliation': 'Division of Cancer Epidemiology (C020), German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Kauczor', 'Affiliation': 'Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Claus-Peter', 'Initials': 'CP', 'LastName': 'Heussel', 'Affiliation': 'Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Hermann', 'Affiliation': 'Epidemiological Cancer Registry Baden-Württemberg, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Sylke Ruth', 'Initials': 'SR', 'LastName': 'Zeissig', 'Affiliation': 'Cancer Registry of Rhineland-Palatinate, Mainz, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Delorme', 'Affiliation': 'Department of Radiology, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Kaaks', 'Affiliation': 'Division of Cancer Epidemiology (C020), German Cancer Research Center (DKFZ), Heidelberg, Germany.'}]",International journal of cancer,['10.1002/ijc.33295']
2038,32925628,Elective Labor Induction at 39 Weeks of Gestation Compared With Expectant Management: Factors Associated With Adverse Outcomes in Low-Risk Nulliparous Women.,"OBJECTIVE


To evaluate characteristics associated with adverse outcomes in low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management.
METHODS


We conducted a secondary analysis of women randomized during the 38th week to induction at 39 weeks of gestation or expectant management. Deliveries before 39 weeks of gestation and those not adherent to study protocol or with fetal anomalies were excluded. A composite of adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage were evaluated. Log binomial regression models estimated relative risks and 95% CIs for associations of outcomes with patient characteristics including randomly assigned treatment group. Interactions between patient characteristics and treatment group were tested.
RESULTS


Of 6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis. Frequency of the perinatal composite was 252 (5.0%), 166 (3.3%) for third- or fourth-degree perineal laceration, and 237 (4.7%) for postpartum hemorrhage. In multivariable analysis, intended labor induction at 39 weeks of gestation was associated with a reduced perinatal composite outcome (4.1% vs 6.0%; adjusted relative risk [aRR] 0.71; 95% CI 0.55-0.90), whereas increasing body mass index (BMI) was associated with an increased perinatal composite outcome (aRR 1.04/unit increase; 95% CI 1.02-1.05). Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60). Increased risk of postpartum hemorrhage was observed in Hispanic women compared with White women (6.3% vs 4.0%; aRR 1.64; 95% CI 1.18-2.29). Patient characteristics associated with adverse outcomes were similar between treatment groups (P for interaction >.05).
CONCLUSION


Compared with expectant management, intended induction at 39 weeks of gestation was associated with reduced risk of adverse perinatal outcome. Patient characteristics associated with adverse outcomes were few and similar between groups.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01990612.",2020,Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60).,"['low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management', '6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis', 'Low-Risk Nulliparous Women']","['Elective Labor Induction at 39 Weeks of Gestation', 'Expectant Management']","['Decreased risk of third- or fourth-degree perineal laceration', 'BMI', 'Frequency of the perinatal composite', 'body mass index (BMI', 'Increased risk of postpartum hemorrhage', 'perinatal composite outcome', 'adverse outcomes', 'reduced risk of adverse perinatal outcome', 'adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage', 'postpartum hemorrhage']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1275806', 'cui_str': 'Fourth degree perineal laceration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043246', 'cui_str': 'Laceration'}]",6096.0,0.346142,Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60).,"[{'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ""Departments of Obstetrics and Gynecology, Stanford University, Stanford, California, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.""}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': ''}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': ''}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ''}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004055']
2039,32925629,Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy.,"OBJECTIVE


To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy.
METHODS


This is a secondary analysis of low-risk nulliparous women randomized to induction of labor at 39 weeks or expectant management. During the trial, the Data and Safety Monitoring Committee requested additional fields on the screening log, which already included race and ethnicity: maternal age, type of insurance, and the reason for declining consent if declined.
RESULTS


From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial. Consent was more likely for Black women (41%, adjusted odds ratio [aOR] 1.47, 95% CI 1.24-1.74), and less likely for Asian women (15%, aOR 0.64, 95% CI 0.48-0.84), compared with White women (24%). Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%). Younger women were also more likely to consent. Among eligible women who declined participation and provided a reason (68%), preference to be expectantly managed (85%) was most common, a response more common in Asian women (aOR 1.75, 95% CI 1.31-2.33) and less common in women without private insurance (aOR 0.60, 95% CI 0.51-0.70). Not wanting to participate in research was more common in Asian women (aOR 2.41, 95% CI 1.44-4.03). Declining consent because family or friends objected was more common in Asian women (aOR 2.51, 95% CI 1.27-4.95) and women without private insurance (aOR 1.68, 95% CI 1.10-2.59).
CONCLUSION


Frequency of consent and reasons for declining consent were associated with age, type of insurance, and race and ethnicity. These findings should be considered when developing recruitment strategies that promote diverse participant representation.
CLINICAL TRIAL REGISTRATION


ClinialTrials.gov, NCT01990612.",2020,"Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%).","['low-risk nulliparous women', 'From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial', 'Younger women']",[],[],"[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],[],7112.0,0.369739,"Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%).","[{'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ""Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch at Galveston, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Pennsylvania, Philadelphia, Pennsylvania, and University of Pittsburgh, Pittsburgh, Pennsylvania; and the George Washington University Biostatistics Center, Washington, DC.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'de Voest', 'Affiliation': ''}, {'ForeName': 'Sabine Z', 'Initials': 'SZ', 'LastName': 'Bousleiman', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Allard', 'Affiliation': ''}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Salazar', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Felecia', 'Initials': 'F', 'LastName': 'Ortiz', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bartholomew', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dalton', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bickus', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003998']
2040,32925634,Customized Probability of Vaginal Delivery With Induction of Labor and Expectant Management in Nulliparous Women at 39 Weeks of Gestation.,"OBJECTIVE


To develop models to predict vaginal delivery in low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation.
METHODS


We conducted a secondary analysis of a randomized controlled trial of planned elective induction of labor at 39 weeks of gestation compared with expectant management for low-risk nulliparous women. Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm). Multivariable logistic regression models were developed for each group using patient characteristics that would be available at the time of counseling. Model selection was based on k-fold cross-validation using backward elimination and variables that remained significant at P<.05 were retained. To compare estimated with observed rates, the elective induction of labor model was then applied to each woman in both groups to estimate individualized predicted probabilities of vaginal delivery with elective induction of labor.
RESULTS


Of 6,106 women enrolled in the trial, 4,661 met criteria for this analysis. Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005). The final elective induction of labor model included age, height, weight, and modified Bishop score (area under the receiver operating characteristic curve [AUROC] 0.72, 95% CI 0.70-0.75). The same variables were included in the final expectant management model (AUROC 0.70, 95% CI 0.67-0.72). Across the range of predicted probability deciles derived from the elective induction of labor model, almost all women who underwent elective induction of labor at 39 weeks of gestation had a higher observed chance of vaginal delivery than expectant management.
CONCLUSION


Irrespective of the individual predicted chance of vaginal delivery from elective induction of labor at 39 weeks of gestation, vaginal delivery is generally more frequent if elective induction of labor is undertaken rather than expectant management. These data can be used to counsel nulliparous women regarding their ""customized"" chances of vaginal delivery as they choose between elective induction of labor or expectant management at 39 weeks of gestation.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01990612.",2020,"Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005).","['Nulliparous Women at 39 Weeks of Gestation', 'counsel nulliparous women', 'low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation', 'low-risk nulliparous women', '6,106 women enrolled in the trial', 'Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the']","['Vaginal Delivery With Induction of Labor and Expectant Management', 'expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm', 'expectant management', 'planned elective induction of labor']","['Vaginal delivery', 'chance of vaginal delivery']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]",6106.0,0.0517142,"Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005).","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ""Departments of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, Stanford University, Stanford, California, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, and Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.""}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': ''}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': ''}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ''}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004046']
2041,32926423,Effects of thermal softening of endotracheal tubes on postoperative sore throat: A randomized double-blinded trial.,"BACKGROUND


Postoperative throat complications after intubation are undesirable but frequent outcomes. A randomized, double-blinded study was performed to determine whether thermal softening of endotracheal tubes reduced throat complications after intubation.
METHODS


Patients (n = 196) undergoing nasal surgery were randomly allocated into the control group and thermal softening groups. Sore throat and hoarseness were evaluated 1 and 24 hours after extubation. The severity of sore throat was evaluated using the numeric rating scale (NRS). The primary outcome was the incidence of sore throat 1 hour after extubation and sore throat was defined as a painful or scratchy feeling in the throat. The secondary outcomes were the incidence of hoarseness 1 hour after extubation, the incidence of sore throat and hoarseness 24 hours after extubation, severity of sore throat, and vocal cord injuries.
RESULTS


The incidence of sore throat 1 hour after extubation was lower in the thermal softening group than in the control group (35.1% vs 52.7%, P = .02). Moreover, thermal softening decreased the mean NRS score for sore throat in the thermal softening group by 10% an hour after extubation (thermal softening group, 1.29 [95% CI, 0.88-1.70] vs control group, 2.33 [95% CI, 1.77-2.89]; P < .01). At 24 hours after extubation, the incidence of sore throat (38.3% vs 40.7%, P = .77) and hoarseness (34.0% vs 35.2%, 0.95 [0.52-1.74], P = .74) were comparable between the two groups.
CONCLUSIONS


Intubation using endotracheal tubes with thermal softening significantly decreased the incidence of sore throat 1 hour after extubation when compared with endotracheal tubes without thermal softening.",2020,"The incidence of sore throat 1 hour after extubation was lower in the thermal softening group than in the control group (35.1% vs. 52.7%, P = 0.02).",['Patients (n= 196) undergoing nasal surgery'],"['thermal softening of endotracheal tubes', 'control group and thermal softening groups']","['incidence of sore throat 1 hour after extubation and sore throat was defined as a painful or scratchy feeling in the throat', 'hoarseness', 'incidence of hoarseness 1 hour after extubation, the incidence of sore throat and hoarseness 24 hours after extubation, severity of sore throat, and vocal cord injuries', 'throat complications', 'postoperative sore throat', 'incidence of sore throat 1 hour after extubation', 'incidence of sore throat', 'numeric rating scale', 'mean numeric rating scale score for sore throat', 'Sore throat and hoarseness', 'severity of sore throat']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0188970', 'cui_str': 'Operation on nose'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3887441', 'cui_str': 'Scratchy sensation'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",196.0,0.32656,"The incidence of sore throat 1 hour after extubation was lower in the thermal softening group than in the control group (35.1% vs. 52.7%, P = 0.02).","[{'ForeName': 'Je Hyuk', 'Initials': 'JH', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hye-Sun', 'Initials': 'HS', 'LastName': 'Paik', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Armed Forces Capital Hospital, Seongnam, Korea.'}, {'ForeName': 'Ho Geol', 'Initials': 'HG', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13705']
2042,32945777,Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation: Protocol for the Development of a Mobile Randomized Controlled Trial.,"BACKGROUND


Cancer patients who undergo allogeneic hematopoietic stem cell transplantation are among the most medically fragile patient populations with extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Moreover, an increased number of allogeneic hematopoietic stem cell transplantations are being performed worldwide, and this expensive procedure has significant economic consequences. Thus, the health and well-being of family caregivers have attracted widespread attention. Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
OBJECTIVE


This protocol aims to leverage technology to deliver a novel caregiver-facing mobile health intervention named Roadmap 2.0. We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation.
METHODS


The Roadmap 2.0 intervention will consist of a mobile randomized trial comparing a positive psychology intervention arm with a control arm in family caregiver-patient dyads. The primary outcome will be caregiver health-related quality of life, as assessed by the PROMIS Global Health scale at day 120 post-transplant. Secondary outcomes will include other PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety. Semistructured qualitative interviews will be conducted among participants at the completion of the study. We will also measure objective physiological markers (eg, sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through electronic health records.
RESULTS


We plan to enroll 166 family caregiver-patient dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval from our health information technology services. Owing to the COVID-19 pandemic, the study has been briefly put on hold. However, recruitment began in August 2020. We have converted all recruitment, enrollment, and onboarding processes to be conducted remotely through video telehealth. Consent will be obtained electronically through the Roadmap 2.0 app.
CONCLUSIONS


This mobile randomized trial will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver health-related quality of life over a 16-week study period. This study will provide additional data on the effects of wearable wrist sensors on caregiver and patient self-report outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04094844; https://www.clinicaltrials.gov/ct2/show/NCT04094844.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/19288.",2020,"Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
","['Family Caregivers and Patients Undergoing Hematopoietic Stem Cell Transplantation', 'Cancer patients who undergo allogeneic hematopoietic stem cell transplantation', '166 family caregiver-patient dyads for the full data analysis', 'family caregivers of patients undergoing hematopoietic stem cell transplantation']",['positive psychology intervention arm with a control arm in family caregiver-patient dyads'],"['objective physiological markers (eg, sleep, activity, heart rate', 'caregiver health-related quality of life', 'caregiver health-related quality of life, as assessed by the PROMIS Global Health scale', 'PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.40449,"Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rozwadowski', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Manasa', 'Initials': 'M', 'LastName': 'Dittakavi', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mazzoli', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Afton L', 'Initials': 'AL', 'LastName': 'Hassett', 'Affiliation': 'Department of Anesthesia, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Braun', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Barton', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Carlozzi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Muneesh', 'Initials': 'M', 'LastName': 'Tewari', 'Affiliation': 'Department of Internal Medicine, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hanauer', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Sung Won', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, University of Michigan, Ann Arbor, MI, United States.'}]",JMIR research protocols,['10.2196/19288']
2043,32945875,Effect of 2 Integrated Interventions on Alcohol Abstinence and Viral Suppression Among Vietnamese Adults With Hazardous Alcohol Use and HIV: A Randomized Clinical Trial.,"Importance


Hazardous and heavy alcohol use is common among people living with HIV and may decrease antiretroviral therapy (ART) adherence, but limited data exist from randomized clinical trials about the effects of interventions on viral load.
Objective


To compare the efficacy of 2 scalable ART clinic-based interventions on alcohol use and viral suppression.
Design, Setting, and Participants


This 3-group randomized clinical trial was conducted among 440 adults with HIV who were being treated at 7 ART clinics in Thai Nguyen, Vietnam. Adults receiving ART with hazardous alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥4 for men or ≥3 for women) and no plans to leave Thai Nguyen were included. Data were collected from March 2016 to May 2018 and analyzed from June 2018 to February 2020.
Interventions


Participants were randomly assigned (1:1:1) to standard of care (SOC), a combined intervention of motivational enhancement therapy and cognitive behavioral therapy (6 in-person sessions of 1 hour each and 3 optional group sessions), or a brief intervention with similar components as the combined intervention but consisting of 2 shorter in-person sessions and 2 telephone sessions.
Main Outcomes and Measures


The primary study outcomes were percentage of days abstinent from alcohol, confirmed using the alcohol biomarker phosphatidylethanol, and viral suppression at 12 months after enrollment.
Results


A total of 440 eligible individuals (mean [SD] age, 40.2 [5.8] years; 426 [96.8%] men) were enrolled; 147 (33.4%) were assigned to the combined intervention, 147 (33.4%) to the brief intervention, and 146 (33.2%) to SOC. In the combined intervention group, 112 participants (76.2%) attended all 6 sessions, and in the brief intervention group, 124 (84.4%) attended all 4 sessions; in the whole sample, 390 (88.6%) completed 12 months of follow-up. At 12 months, the mean (SE) percentage of days abstinent was 65% (3.1%) among those in the combined intervention group, 65% (3.2%) among those in the brief intervention group, and 50% (3.4%) among those in the in the SOC group (Cohen d for combined intervention vs SOC and brief intervention vs SOC: 39%; 95% CI, 15% to 64%). Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%).
Conclusions and Relevance


In this study, the brief intervention resulted in a significant increase in percentage of days abstinent from alcohol and a significant increase in viral suppression after 12 months. Future implementation science studies evaluating scale-up of the brief intervention are needed.
Trial Registration


ClinicalTrials.gov Identifier: NCT02720237.",2020,"Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%).
","['Adults receiving ART with hazardous alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥4 for men or ≥3 for women) and no plans to leave Thai Nguyen were included', '440 adults with HIV who were being treated at 7 ART clinics in Thai Nguyen, Vietnam', 'Vietnamese Adults With Hazardous Alcohol Use and HIV', '440 eligible individuals (mean [SD] age, 40.2 [5.8] years; 426 [96.8%] men) were enrolled; 147 (33.4', 'people living with HIV', 'Data were collected from March 2016 to May 2018 and analyzed from June 2018 to February 2020']","['2 Integrated Interventions', 'standard of care (SOC), a combined intervention of motivational enhancement therapy and cognitive behavioral therapy (6 in-person sessions of 1 hour each and 3 optional group sessions), or a brief intervention with similar components as the combined intervention but consisting of 2 shorter in-person sessions and 2 telephone sessions']","['Viral suppression', 'Alcohol Abstinence and Viral Suppression', 'viral suppression', 'percentage of days abstinent from alcohol', 'mean (SE) percentage of days abstinent', 'percentage of days abstinent from alcohol, confirmed using the alcohol biomarker phosphatidylethanol, and viral suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C4706350', 'cui_str': 'AUDIT-C (Alcohol Use Disorders Identification Test - Consumption) score'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0678274', 'cui_str': 'Alcohol Abstinence'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0070787', 'cui_str': 'Phosphatidylethanol'}]",440.0,0.0729123,"Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%).
","[{'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, School of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Tran V', 'Initials': 'TV', 'LastName': 'Ha', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Nguyen V T', 'Initials': 'NVT', 'LastName': 'Mai', 'Affiliation': 'Vinmec Healthcare System, Hanoi, Vietnam.'}, {'ForeName': 'Bui X', 'Initials': 'BX', 'LastName': 'Quynh', 'Affiliation': 'University of North Carolina Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Vu', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'University of North Carolina Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Blackburn', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Hershow', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.17115']
2044,32945926,[Treatment of asymptomatic aortic stenosis : RECOVERY trial (randomized comparison of early surgery versus conventional treatment in very severe aortic stenosis)].,,2020,,"['asymptomatic aortic stenosis ', 'very severe aortic stenosis']",['early surgery versus conventional treatment'],[],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0233211,,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kutschka', 'Affiliation': 'Klinik für Thorax‑, Herz- und Gefäßchirurgie, Universitätsmedizin Göttingen, Georg-August-Universität, Robert-Koch-Str.\xa040, 37075, Göttingen, Deutschland. ingo.kutschka@med.uni-goettingen.de.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nitschmann', 'Affiliation': ', Lippetal, Deutschland.'}]",Der Internist,['10.1007/s00108-020-00868-z']
2045,32949267,"A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers.","PURPOSE


To compare pharmacokinetics, safety, tolerability, and immunogenicity between SB8, a bevacizumab biosimilar, and the European Union (EU) and United States (US) reference products (bevacizumab-EU, bevacizumab-US).
METHODS


In this randomized, double-blind, parallel-group, and single-dose study, healthy volunteers were randomized to receive a 3 mg/kg dose of SB8, bevacizumab-EU, or bevacizumab-US via intravenous infusion. Primary endpoints were area under the concentration-time curve from time zero to infinity (AUC inf ) and to the last quantifiable concentration (AUC last ), and maximum observed serum concentration (C max ). Bioequivalence was achieved if 90% confidence intervals (CIs) for the ratios of the geometric least squares means (LSMeans) of primary endpoints were within the predefined bioequivalence margins of 80.00-125.00%. Safety and immunogenicity were also investigated.
RESULTS


The 90% CIs for the geometric LSMean ratios of AUC inf , AUC last  and C max  were all within the prespecified bioequivalence margins. Geometric LSMean ratios for SB8/bevacizumab-EU, SB8/bevacizumab-US and bevacizumab-EU/bevacizumab-US were 88.01%, 88.48% and 100.54% for AUC inf , 88.65%, 89.08% and 100.49% for AUC last  and 99.59%, 101.15% and 101.56% for C max , respectively. Incidence of treatment-emergent adverse events (TEAEs) across treatment groups was comparable (SB8: 50.0%, bevacizumab-EU: 37.5%, bevacizumab-US: 53.8%). Most TEAEs were mild and considered as not related to the study drug. No deaths or treatment discontinuations due to adverse events occurred. Incidence of anti-drug antibodies was also comparable between all groups and no neutralizing antibodies were detected.
CONCLUSION


This study demonstrated pharmacokinetic bioequivalence and similar safety and immunogenicity profiles of SB8 to both reference products, bevacizumab-EU and bevacizumab-US, and of bevacizumab-EU to bevacizumab-US. CLINICALTRIALS.
GOV IDENTIFIER


NCT02453672 (submitted date); EudraCT number: 2015-001,026-41.",2020,"Incidence of treatment-emergent adverse events (TEAEs) across treatment groups was comparable (SB8: 50.0%, bevacizumab-EU: 37.5%, bevacizumab-US: 53.8%).",['healthy volunteers'],"['sb8 (bevacizumab biosimilar) with reference bevacizumab', 'bevacizumab-EU', 'SB8, bevacizumab-EU, or bevacizumab-US via intravenous infusion', 'bevacizumab', 'bevacizumab-EU/bevacizumab', 'bevacizumab-EU and bevacizumab-US, and of bevacizumab-EU to bevacizumab-US', 'European Union (EU) and United States (US) reference products (bevacizumab-EU, bevacizumab-US']","['geometric LSMean ratios of AUC inf , AUC last  and C max', 'neutralizing antibodies', 'Safety and immunogenicity', 'area under the concentration-time curve from time zero to infinity (AUC inf ) and to the last quantifiable concentration (AUC last ), and maximum observed serum concentration (C max ', 'pharmacokinetics, safety, tolerability, and immunogenicity', 'Geometric LSMean ratios', 'Incidence of anti-drug antibodies']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.141577,"Incidence of treatment-emergent adverse events (TEAEs) across treatment groups was comparable (SB8: 50.0%, bevacizumab-EU: 37.5%, bevacizumab-US: 53.8%).","[{'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Medical Affairs, Samsung Bioepis Co., Ltd, Incheon, Korea. dh01.shin@samsung.com.'}, {'ForeName': 'Yoon Jung', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Clinical Development, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Biometrics, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Dahyoung', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Clinical Bioanalysis, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Minjeong', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Medical Affairs, Samsung Bioepis Co., Ltd, Incheon, Korea.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Petkova', 'Affiliation': 'Clinical Pharmacology Unit, SGS LSS, Antwerpen, Lange Beeldekensstraat 267, 2060, Antwerpen, Belgium.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04144-7']
2046,32920164,Building resilience to body image triggers using brief cognitive training on a mobile application: A randomized controlled trial.,"OBJECTIVE


Body image disturbance (BID) is common among women, characterized by persistent and distressing appearance dissatisfaction, and linked with eating disorders. Although effective, cognitive behavioral therapy (CBT) delivered by trained professionals is not easily accessible. This randomized trial evaluated the effects of a CBT-based mobile application designed to increase resilience to body image triggers and reduce BID symptoms.
METHOD


A non-clinical sample of women (N = 90; M age  = 23.52) was randomized to use the mobile application for approximately 4 min of daily exercises for two weeks or to a control condition. Body image was measured at baseline, immediately after two weeks of mobile application use, and at 1-month follow-up. To examine whether using the application was associated with increased resilience to common BID triggers, participants completed an Instagram exposure resilience task upon completion and at 1-month follow-up.
RESULTS


Relative to those in the control condition, participants who used the application demonstrated increased resiliency and reduced BID symptoms. Theses effects were medium-to-large and were maintained at 1-month follow-up.
CONCLUSION


These results underscore the potential usefulness of brief, low-intensity, portable interventions in reducing BID symptoms and in increasing resilience to thin-ideal body messages often portrayed on social media.",2020,"Relative to those in the control condition, participants who used the application demonstrated increased resiliency and reduced BID symptoms.",['A non-clinical sample of women (N\xa0=\xa090; M age \xa0=\xa023.52'],"['cognitive training', 'cognitive behavioral therapy (CBT', 'CBT-based mobile application']","['Body image', 'resiliency and reduced BID symptoms']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0449784,"Relative to those in the control condition, participants who used the application demonstrated increased resiliency and reduced BID symptoms.","[{'ForeName': 'Dinur', 'Initials': 'D', 'LastName': 'Aboody', 'Affiliation': ""Baruch Ivcher School of Psychology, Interdisciplinary Center Herzliya, 8 Ha'universuta St. Herzliya, 46150, Israel. Electronic address: dinur@me.com.""}, {'ForeName': 'Jedidiah', 'Initials': 'J', 'LastName': 'Siev', 'Affiliation': 'Department of Psychology, Swarthmore College, 500 College Ave, Swarthmore, PA, 19081, United States. Electronic address: jsiev1@swarthmore.edu.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Doron', 'Affiliation': ""Baruch Ivcher School of Psychology, Interdisciplinary Center Herzliya, 8 Ha'universuta St. Herzliya, 46150, Israel. Electronic address: gdoron@idc.ac.il.""}]",Behaviour research and therapy,['10.1016/j.brat.2020.103723']
2047,32921872,[Prognostic implications of myocardial injury in patients with and without COVID-19 infection treated in a university hospital].,"INTRODUCTION AND OBJECTIVES


Cardiac troponin, a marker of myocardial injury, is frequently observed in patients with COVID-19 infection. Our objective was to analyze myocardial injury and its prognostic implications in patients with and without COVID-19 infection treated in the same period of time.
METHODS


The present study included patients treated in a university hospital with cardiac troponin I measurements and with suspected COVID-19 infection, confirmed or ruled out by polymerase chain reaction analysis. The impact was analyzed of cardiac troponin I positivity on 30-day mortality.
RESULTS


In total, 433 patients were distributed among the following groups: confirmed COVID-19 (n = 186), 22% with myocardial injury (n = 41); and ruled out COVID-19 (n = 247), 21.5% without myocardial injury (n = 52). The confirmed and ruled out COVID-19 groups had a similar age, sex, and cardiovascular history. Mortality was significantly higher in the confirmed COVID-19 group than in the ruled out group (19.9% vs 5.3%, P < .001). In Cox multivariate regression analysis, cardiac troponin I was a predictor of mortality in both groups (confirmed COVID-19 group: HR, 3.54; 95%CI, 1.70-7.34; P = .001; ruled out COVID-19 group: HR, 5.57; 95%CI, 1.70-18.20; P = .004). The predictive model analyzed by ROC curves was similar in the 2 groups (P = .701), with AUCs of 0.808 in the confirmed COVID-19 group (0.750-0.865) and 0.812 in the ruled out COVID-19 group (0.760-0.864).
CONCLUSIONS


Myocardial injury is detected in 1 in every 5 patients with confirmed or ruled out COVID-19 and predicts 30-day mortality to a similar extent in both circumstances.",2020,"The predictive model analyzed by ROC curves was similar in the 2 groups (P = .701), with AUCs of 0.808 in the confirmed COVID-19 group (0.750-0.865) and 0.812 in the ruled out COVID-19 group (0.760-0.864).
","['patients with COVID-19 infection', 'patients treated in a university hospital with cardiac troponin', '433 patients were distributed among the following groups: confirmed COVID-19 (n\u2009=\u2009186), 22% with myocardial injury (n\u2009=\u200941); and ruled out COVID-19 (n\u2009=\u2009247), 21.5% without myocardial injury (n\u2009=\u200952', 'patients with and without COVID-19 infection treated in the same period of time', 'patients with and without COVID-19 infection treated in a university hospital']",[],"['Mortality', 'cardiac troponin', '30-day mortality', 'ROC curves', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}]",433.0,0.232322,"The predictive model analyzed by ROC curves was similar in the 2 groups (P = .701), with AUCs of 0.808 in the confirmed COVID-19 group (0.750-0.865) and 0.812 in the ruled out COVID-19 group (0.760-0.864).
","[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Bardají', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Carrasquer', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Sánchez-Giménez', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Lal-Trehan', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Del-Moral-Ronda', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Óscar M', 'Initials': 'ÓM', 'LastName': 'Peiró', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Bonet', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Gislaine', 'Initials': 'G', 'LastName': 'Castilho', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Fort-Gallifa', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, España.""}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Benavent', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, España.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Recio', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, España.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gutiérrez', 'Affiliation': ""Laboratori Clínic ICS Camp de Tarragona-Terres de l'Ebre, Instituto Catalán de la Salud, Tarragona, España.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Villavicencio', 'Affiliation': 'Servicio de Cuidados Intensivos, Hospital Universitario de Tarragona Joan XXIII, Tarragona, España.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Auguet', 'Affiliation': 'Universidad Rovira Virgili, Tarragona, España.'}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Boqué', 'Affiliation': 'Universidad Rovira Virgili, Tarragona, España.'}]",Revista espanola de cardiologia,['10.1016/j.recesp.2020.08.009']
2048,32921876,Estimating the fraction of unreported infections in epidemics with a known epicenter: An application to COVID-19.,"We develop an analytically tractable method to estimate the fraction of unreported infections in epidemics with a known epicenter and estimate the number of unreported COVID-19 infections in the U.S. during the first half of March 2020. Our method utilizes the covariation in initial reported infections across U.S. regions and the number of travelers to these regions from the epicenter, along with the results of an early randomized testing study in Iceland. Using our estimates of the number of unreported infections, which are substantially larger than the number of reported infections, we also provide estimates for the infection fatality rate using data on reported COVID-19 fatalities from U.S. counties.",2020,We develop an analytically tractable method to estimate the fraction of unreported infections in epidemics with a known epicenter and estimate the number of unreported COVID-19 infections in the U.S. during the first half of March 2020.,[],[],[],[],[],[],,0.031995,We develop an analytically tractable method to estimate the fraction of unreported infections in epidemics with a known epicenter and estimate the number of unreported COVID-19 infections in the U.S. during the first half of March 2020.,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hortaçsu', 'Affiliation': 'Kenneth C. Griffin Department of Economics, University of Chicago, United States of America.'}, {'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Kenneth C. Griffin Department of Economics, University of Chicago, United States of America.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Schwieg', 'Affiliation': 'Becker Friedman Institute, United States of America.'}]",Journal of econometrics,['10.1016/j.jeconom.2020.07.047']
2049,32925739,"Adding systematic biopsy to magnetic resonance ultrasound fusion targeted biopsy of the prostate in men with previous negative biopsy or enrolled in active surveillance programs: A prospective single center, randomized study.","Magnetic resonance imaging (MRI) targeted biopsy (TBx) of the prostate demonstrated to improve detection rate (DR) of clinically significant prostate cancer (csPCa) in biopsy-naive patients achieving strong level of evidence. Nevertheless, the csPCa yield for TBx alone versus TBx plus systematic biopsy (SBx) after accounting for overlapping of SBx cores with TBx cores, in prior-negative or active surveillance (AS) patients has not been well established.The objective of the study was to investigate benefits in terms of detection rate and pathological stratification of prostate cancer (PCa) using contextual SBx during MRI-TBx.Patients previously submitted to negative-SBx (cohort A) and those enrolled in an AS program (cohort B) who showed at least 1 suspicious area with a PIRADSv2 score ≥ 3 were prospectively and randomly assigned to only TBx strategy versus TBx plus SBx strategy. SBx locations could not encompass the TBx sites, so that the results of each type of biopsy were independent and did not overlap.A total of 312 patients were included in the 2 cohorts (cohort A: 213 cases; cohort B: 99 cases). No significant differences were found in terms of overall PCa-DR (77.6% vs 69.6% respectively; P = .36) and csPCa-DR (48.2% vs 60.9 respectively; P = .12). The MRI-TBx alone cohort showed higher csPCa/PCa ratio (87.5% vs 62.2%; P = .03). The MRI-TBx plus SBx group subanalysis showed significantly higher csPCa-DR obtained at the MRI-TBx cores when compared with the SBx cores (43.7% vs 24.1%, respectively; P = .01). Independently to age, prostatic-specific antigen and prostate imaging-reporting and data system score, either in rebiopsy (OR 0.43, 0.21-0.97) or AS (OR 0.46, 0.32-0.89) setting, SBx cores were negatively associated with the csPCa-DR when combined to TBx cores.MRI-TBx should be considered the elective method to perform prostate biopsy in patients with previous negative SBx and those considered for an AS program. Adding SBx samples to MRI-TBx did not improve detection rate of csPCa.",2020,No significant differences were found in terms of overall PCa-DR (77.6% vs 69.6% respectively; P = .36) and csPCa-DR (48.2% vs 60.9 respectively; P = .12).,"['men with previous negative biopsy or enrolled in active surveillance programs', 'Patients previously submitted to negative-SBx (cohort A) and those enrolled in an AS program (cohort B) who showed at least 1 suspicious area with a PIRADSv2 score\u200a≥\u200a3', '312 patients were included in the 2 cohorts (cohort A: 213 cases; cohort B: 99 cases']","['magnetic resonance ultrasound fusion targeted biopsy', 'TBx strategy versus TBx plus SBx strategy', 'Magnetic resonance imaging (MRI) targeted biopsy (TBx']","['overall PCa-DR', 'detection rate of csPCa', 'csPCa/PCa ratio', 'csPCa-DR', 'detection rate (DR']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",312.0,0.0363428,No significant differences were found in terms of overall PCa-DR (77.6% vs 69.6% respectively; P = .36) and csPCa-DR (48.2% vs 60.9 respectively; P = .12).,"[{'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Porreca', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Del Giudice', 'Affiliation': 'Department of Maternal-Child and Urological Sciences, ""Sapienza"" Rome University, Policlinico Umberto I Hospital, Rome.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Giampaoli', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': ""D'Agostino"", 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Romagnoli', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corsi', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Del Rosso', 'Affiliation': 'Department of Urology, Policlinico Abano Terme, Abano Terme (PD).'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Maggi', 'Affiliation': 'Department of Maternal-Child and Urological Sciences, ""Sapienza"" Rome University, Policlinico Umberto I Hospital, Rome.'}, {'ForeName': 'Benjamin I', 'Initials': 'BI', 'LastName': 'Chung', 'Affiliation': 'Department of Urology, European Institute of Oncology (IEO), Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Ferro', 'Affiliation': 'Department of Urology, European Institute of Oncology, IRCCS.'}, {'ForeName': 'Ottavio', 'Initials': 'O', 'LastName': 'de Cobelli', 'Affiliation': 'Department of Urology, European Institute of Oncology, IRCCS.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lucarelli', 'Affiliation': 'Department of Emergency and Organ Transplantation-Urology, Andrology and Kidney Transplantation Unit, University of Bari, Bari.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Schiavina', 'Affiliation': 'Department of Urology, Alma Mater Studiorum Bologna, Policlinico S. Orsola Malpighi, Bologna, Italy.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'De Berardinis', 'Affiliation': 'Department of Maternal-Child and Urological Sciences, ""Sapienza"" Rome University, Policlinico Umberto I Hospital, Rome.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sciarra', 'Affiliation': 'Department of Maternal-Child and Urological Sciences, ""Sapienza"" Rome University, Policlinico Umberto I Hospital, Rome.'}, {'ForeName': 'Gian Maria', 'Initials': 'GM', 'LastName': 'Busetto', 'Affiliation': 'Department of Maternal-Child and Urological Sciences, ""Sapienza"" Rome University, Policlinico Umberto I Hospital, Rome.'}]",Medicine,['10.1097/MD.0000000000022059']
2050,32925743,Tranexamic acid reduces blood cost in long-segment spinal fusion surgery: A randomized controlled study protocol.,"OBJECTIVE


Long-segment spinal fusion surgery was associated with substantial perioperative blood loss which may increase hospitalization expenses and mortality rates. Substantial studies have reported that tranexamic acid (TXA) could reduce blood products and cost after joint arthroplasty surgery. However, there still exists controversy regarding the efficacy of TXA in long-segment spinal fusion surgery. We performed this protocol to design a randomized controlled study to evaluate the efficacy of TXA in decreasing transfusion rate of allogeneic blood products and transfusion cost in degenerative lumbar scoliosis patients.
METHODS


This study was carried out as a double-blinded, randomized clinical trial on patients with degenerative lumbar scoliosis who prepared for long-segment spinal fusion surgery from December 2018 to December 2019. It was authorized via the Institutional Review Committee in Southwest Medical University (ky2019225). Eighty patients were divided randomly into 2 groups (Experimental group = 40, control group = 40). The patients in the experimental group received 1000 mg of TXA mixed in 100 mL normal saline as a single dose intravenously over 20 minutes before the skin incision was made. Control group received equivalent normal saline without TXA. Primary outcomes included total blood loss, estimated intraoperative blood loss, hematocrit and hemoglobin decline, postoperative drain amount, intra-/postoperative allogeneic transfusion amount and rate, and total transfusion cost. Secondary outcomes included surgical time, thrombotic complications including deep vein thrombosis and pulmonary embolism. All the needed analyses were implemented through utilizing SPSS for Windows Version 20.0.
RESULTS


Table showed the relevant clinical outcomes between experimental group and control group.
CONCLUSION


We hypothesized that TXA was effective and safe in reducing blood transfusion and cost in long-segment spinal fusion surgery.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5854).",2020,Substantial studies have reported that tranexamic acid (TXA) could reduce blood products and cost after joint arthroplasty surgery.,"['long-segment spinal fusion surgery', 'Eighty patients', 'patients with degenerative lumbar scoliosis who prepared for long-segment spinal fusion surgery from December 2018 to December 2019', 'degenerative lumbar scoliosis patients']","['equivalent normal saline without TXA', 'tranexamic acid (TXA', 'TXA mixed in 100 mL normal saline', 'TXA', 'Tranexamic acid']","['blood cost', 'surgical time, thrombotic complications including deep vein thrombosis and pulmonary embolism', 'hospitalization expenses and mortality rates', 'blood transfusion and cost', 'total blood loss, estimated intraoperative blood loss, hematocrit and hemoglobin decline, postoperative drain amount, intra-/postoperative allogeneic transfusion amount and rate, and total transfusion cost']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C2748518', 'cui_str': 'Lumbar scoliosis'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",80.0,0.237383,Substantial studies have reported that tranexamic acid (TXA) could reduce blood products and cost after joint arthroplasty surgery.,"[{'ForeName': 'Linyu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Xufeng', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': ""Department of Orthopedics, the People's Hospital of Jianyang City, Sichuan, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Southwest Medical University.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Southwest Medical University.'}]",Medicine,['10.1097/MD.0000000000022069']
2051,32925744,Effects of a multidisciplinary team-led school-based human papillomavirus vaccination health-promotion programme on improving vaccine acceptance and uptake among female adolescents: A cluster randomized controlled trial.,"INTRODUCTION


Evidence has consistently shown the high efficacy of human papillomavirus (HPV) vaccines in preventing cervical cancers. However, the HPV vaccine uptake rate in Hong Kong is very low. We will develop and evaluate an innovative, theory-based multidisciplinary team-led school-based HPV vaccination health-promotion program (MDL-SHPVP), engaging female adolescents, parents/guardians, and secondary school personnel in multicomponent educational strategies and interactive discussions.
METHODS AND ANALYSIS


A cluster randomized controlled trial is proposed. We will recruit 2520 female adolescents and their parents/guardians from 18 secondary day schools. The MDL-SHPVP is underpinned by the Health Belief Model and Precaution Adoption Process Model. Multicomponent interventions will be offered, including education sessions with small group dialogues with a registered nurse and trained healthcare and lay volunteers, and educational computer games. A team of volunteers will be established to raise HPV, cervical cancer, and HPV vaccine awareness. Outcomes include adolescents' uptake of the HPV vaccine, adolescents' intention to receive HPV vaccination, vaccine acceptance among parents/guardians, and parents'/guardians' and adolescents' HPV knowledge, attitudes, and beliefs. Data will be collected at baseline, 1 month, and 1 year after intervention. The generalized estimating equations analysis will be used for comparing the outcomes between the 2 groups.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (Ref. no.: 2019.055). We will disseminate the study findings via peer-reviewed publications and presentations at relevant events and international and local conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT04438291.",2020,"Outcomes include adolescents' uptake of the HPV vaccine, adolescents' intention to receive HPV vaccination, vaccine acceptance among parents/guardians, and parents'/guardians' and adolescents' HPV knowledge, attitudes, and beliefs.","['2520 female adolescents and their parents/guardians from 18 secondary day schools', 'female adolescents']","['multidisciplinary team-led school-based human papillomavirus vaccination health-promotion programme', 'small group dialogues with a registered nurse and trained healthcare and lay volunteers, and educational computer games', 'human papillomavirus (HPV) vaccines']","[""adolescents' uptake of the HPV vaccine, adolescents' intention to receive HPV vaccination, vaccine acceptance among parents/guardians, and parents'/guardians' and adolescents' HPV knowledge, attitudes, and beliefs"", 'HPV vaccine uptake rate', 'vaccine acceptance and uptake']","[{'cui': 'C4517667', 'cui_str': '2520'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",2520.0,0.193298,"Outcomes include adolescents' uptake of the HPV vaccine, adolescents' intention to receive HPV vaccination, vaccine acceptance among parents/guardians, and parents'/guardians' and adolescents' HPV knowledge, attitudes, and beliefs.","[{'ForeName': 'Janita Pak Chun', 'Initials': 'JPC', 'LastName': 'Chau', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'Suzanne Hoi Shan', 'Initials': 'SHS', 'LastName': 'Lo', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'Vivian Wing Yan', 'Initials': 'VWY', 'LastName': 'Lee', 'Affiliation': 'Centre for Learning Enhancement And Research, The Chinese University of Hong Kong.'}, {'ForeName': 'Grace Chung Yan', 'Initials': 'GCY', 'LastName': 'Lui', 'Affiliation': 'Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong.'}, {'ForeName': 'Kam Ming', 'Initials': 'KM', 'LastName': 'Chan', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, United Christian Hospital, Hospital Authority, Hong Kong.'}, {'ForeName': 'Alexander Yuk Lun', 'Initials': 'AYL', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong.'}]",Medicine,['10.1097/MD.0000000000022072']
2052,32925754,The effect of Baduanjin on intestinal flora in patients with prediabetes mellitus: Study protocol for a randomized controlled trial.,"BACKGROUND


The incidence rate of prediabetes is increasing year by year. Prediabetes is a continuous ever fount of diabetes. Diabetes is closely related to intestinal flora imbalance and insulin resistance (IR). Previous studies have proved that Baduanjin can effectively improve the blood glucose and blood lipid of patients, but there is no relevant research on intestinal flora and IR. Therefore, this study focuses on the influence of Baduanjin on intestinal flora of patients with prediabetes, so as to improve the effect of IR, and finally delay or prevent the occurrence of to diabetes mellitus 2 type (T2DM).
METHODS


This study will recruit 80 patients who meet the diagnostic criteria of prediabetes from Hospital of Chengdu University of traditional Chinese Medicine. Eighty patients will be randomly divided into experimental group and control group, 40 cases in each group. The control group received routine lifestyle intervention, and the experimental group received Baduanjin at least 3 to 5 times a week for a total of 6 months. The researchers monitored the intestinal flora, insulin resistance index, blood glucose, blood lipid, body mass index, and other indicators after 3 months of intervention and 6 months of intervention DISCUSSION:: Based on previous studies, intestinal flora is closely related to the occurrence and development of T2DM-IR. Baduanjin can significantly improve the blood glucose and blood lipid of patients with prediabetes, and has a positive effect on the intestinal flora of the elderly and significantly improve the intestinal microecological balance. This study used randomized controlled trial to explore the control method between Baduanjin and conventional lifestyle, in order to further establish the application of Baduanjin in patients with prediabetes.
TRIAL REGISTRATION


This trial protocol has been approved by the research hospital and registered in China clinical trial registration center on July 6, 2020 (ChiCTR2000034490).",2020,"Baduanjin can significantly improve the blood glucose and blood lipid of patients with prediabetes, and has a positive effect on the intestinal flora of the elderly and significantly improve the intestinal microecological balance.","['patients with prediabetes mellitus', 'Eighty patients', 'patients with prediabetes', '80 patients who meet the diagnostic criteria of prediabetes from Hospital of Chengdu University of traditional Chinese Medicine']","['routine lifestyle intervention', 'Baduanjin']","['intestinal microecological balance', 'blood glucose and blood lipid', 'intestinal flora, insulin resistance index, blood glucose, blood lipid, body mass index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",80.0,0.0345877,"Baduanjin can significantly improve the blood glucose and blood lipid of patients with prediabetes, and has a positive effect on the intestinal flora of the elderly and significantly improve the intestinal microecological balance.","[{'ForeName': 'Xiangui', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Maoyi', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu City, Sichuan, PR China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu City, Sichuan, PR China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu City, Sichuan, PR China.'}, {'ForeName': 'Xuedong', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yi', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shunqi', 'Initials': 'S', 'LastName': 'Liao', 'Affiliation': 'Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000022108']
2053,32926502,The Mediterranean diet increases glucagon-like peptide 1 and oxyntomodulin compared with a vegetarian diet in patients with type 2 diabetes: A randomized controlled cross-over trial.,"AIM


To compare a Mediterranean diet (MED) with a high-fibre vegetarian diet (HFV) in terms of hunger-satiety perception through post-prandial assessment of appetite-related hormones glucagon-like peptide 1 (GLP-1) and oxyntomodulin, as well as self-rated visual analogue scale (VAS) quantification, in overweight/obese subjects with type 2 diabetes (T2D).
MATERIALS AND METHODS


Twelve T2D subjects (Male to female ratio = 7:5), mean age 63 ± 8.5 years, were enrolled in a randomized, controlled, crossover study. Participants consumed an MED meal as well as an isocaloric meal rich in complex carbohydrate as well as an isocaloric MED meal in two different visits with a 1-week washout period between the two visits. Appetite ratings, glucose/insulin, and gastrointestinal hormone concentrations were measured at fasting and every 30' until 210' following meal consumption.
RESULTS


GLP-1 and oxyntomodulin levels were significantly higher following MED meal compared with HFV meals (210' area under the curve, p < 0.022 and p < 0.023, respectively). Both MED and HFV meal resulted in a biphasic pattern of GLP-1 and oxyntomodulin, although MED meal was related to a delayed, significantly higher second GLP-1 peak at 150' compared with that of HFV meal (p < 0.05). MED meal was related to lower glucose profile compared with HFV meal (p < 0.039), whereas we did not observe significant changes in terms of self-reported VAS scores and insulin trend.
CONCLUSIONS


In T2D overweight/obese subjects, an MED meal is more effective than a HFV meal in terms of post-prandial plasma glucose homoeostasis and GLP-1 and oxyntomodulin release. These changes were not confirmed by VAS appetite self-assessment over a 210' period.",2020,"MED meal was related to lower glucose profile compared with HFV meal (P <0.039), whereas we did not observe significant changes in terms of self-reported VAS scores and insulin trend.
","['T2D overweight/obese subjects', 'Twelve T2D subjects (Male to female ratio = 7:5), mean age 63 ± 8.5 years', 'Patients with Type 2 Diabetes', 'overweight/obese subjects with type-2 diabetes (T2D']","['high fiber vegetarian (HFV) meal rich in complex carbohydrate', 'Mediterranean Diet', 'Mediterranean dietetic pattern with a vegetarian pattern']","['second GLP-1 peak', 'GLP-1 and Oxyntomodulin levels', 'biphasic pattern of GLP-1 and Oxyntomodulin, although MED meal', 'Appetite ratings, glucose/insulin and gastrointestinal hormone concentrations', 'self-reported VAS scores and insulin trend']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0042441', 'cui_str': 'Vegetarian'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0556154', 'cui_str': 'Complex carbohydrate'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0086379', 'cui_str': 'Glicentin (33-69)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0040833', 'cui_str': 'trends'}]",12.0,0.0209876,"MED meal was related to lower glucose profile compared with HFV meal (P <0.039), whereas we did not observe significant changes in terms of self-reported VAS scores and insulin trend.
","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Mauro', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Tuccinardi', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Mikiko', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Experimental Medicine, Section of Medical Pathophysiology, Food Science and Endocrinology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Del Toro', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Lavinia', 'Initials': 'L', 'LastName': 'Monte', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Giorgino', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Rampa', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Rossini', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Kyanvash', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Soare', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Rosati', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Piccoli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Nicoli', 'Initials': 'N', 'LastName': 'Napoli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Fioriti', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pozzilli', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Yeganeh M', 'Initials': 'YM', 'LastName': 'Khazrai', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Manfrini', 'Affiliation': 'Unit of Endocrinology and Diabetes, Department of Medicine, Campus Bio-Medico University of Rome, Rome, Italy.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3406']
2054,32926748,Irsogladine maleate alters expression of a tight junction protein in portal hypertensive gastropathy.,"BACKGROUND AND AIM


Portal hypertensive gastropathy (PHG) is characterized by noninflammatory edema and vasodilatation of the lamina propria of the mucosal epithelium. In addition, the alterations of intercellular junction proteins and dilatation of the endothelial gaps have been reported. In this study, we examined whether irsogladine maleate (IM), a gastric mucosal protective agent, has the potential to improve PHG by restoration of tight junctions (TJs).
METHODS


Twenty-four patients with PHG were registered and randomly assigned into two groups: 12 patients in the IM-administration group and 12 patients in the non-administration group. In the administration group, IM (4 mg/day) was administered orally for 12 weeks. Gastric mucosa with a red color in patients with PHG were obtained endoscopically on the registration day and 12 weeks later. The endoscopic findings were evaluated, an immunohistochemical analysis of claudin-3 (a TJ protein) expression in gastric mucosal tissues by a laser microscope was performed, and claudin-3 expression was quantified by western blot analysis.
RESULTS


Irsogladine maleate improved the degree of PHG in 2/12 patients endoscopically, in contrast to none of the 12 patients in the non-administration group. Immunohistochemical analysis showed that expression of claudin-3 increased in 8/12 patients in the IM-administration group and 2/12 patients in the non-administration group (P = 0.036). Western blot analysis revealed that the increase in claudin-3 after 12 weeks was significantly higher in the IM-administration group than in the non-administration group (P = 0.010).
CONCLUSIONS


The present pilot study suggested that IM might improve the gastric mucosa in PHG through restoration of TJ-protein claudin-3.",2020,"Immunohistochemical analysis showed that expression of claudin-3 increased in 8/12 patients in the IM-administration group, and 2/12 patients in the non-administration group (p=0.036).","['Gastric mucosa with a red color in patients with PHG', 'portal hypertensive gastropathy', 'Twenty-four patients with PHG']","['Irsogladine maleate', 'irsogladine maleate (IM']","['claudin-3', 'expression of claudin-3', 'degree of PHG']","[{'cui': 'C0017136', 'cui_str': 'Gastric mucous membrane structure'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580174', 'cui_str': 'Portal hypertensive gastropathy'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0091573', 'cui_str': 'irsogladine maleate'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0580174', 'cui_str': 'Portal hypertensive gastropathy'}]",24.0,0.0230502,"Immunohistochemical analysis showed that expression of claudin-3 increased in 8/12 patients in the IM-administration group, and 2/12 patients in the non-administration group (p=0.036).","[{'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Irie', 'Affiliation': 'Department of Gastroenterology and Medicine, Fukuoka University Nishijin Hospital, Fukuoka, Japan.'}, {'ForeName': 'Naoaki', 'Initials': 'N', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Miyayama', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Umeda', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Takata', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Shinjiro', 'Initials': 'S', 'LastName': 'Inomata', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Morihara', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Takeyama', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Shakado', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Shotaro', 'Initials': 'S', 'LastName': 'Sakisaka', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Fumihito', 'Initials': 'F', 'LastName': 'Hirai', 'Affiliation': 'Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15259']
2055,32931919,The assertive cardiac care trial: A randomised controlled trial of a coproduced assertive cardiac care intervention to reduce absolute cardiovascular disease risk in people with severe mental illness in the primary care setting.,"BACKGROUND


Cardiovascular disease (CVD) accounts for 40% of the excess mortality identified in people with severe mental illness (SMI). Modifiable CVD risk factors are higher and can be exacerbated by the cardiometabolic impact of psychotropic medications. People with SMI frequently attend primary care presenting a valuable opportunity for early identification, prevention and management of cardiovascular health. The ACCT Healthy Hearts Study will test a coproduced, nurse-led intervention delivered with general practitioners to reduce absolute CVD risk (ACVDR) at 12 months compared with an active control group.
METHODS/DESIGN


ACCT is a two group (intervention/active control) individually randomised (1:1) controlled trial (RCT). Assessments will be completed baseline (pre-randomisation), 6 months, and 12 months. The primary outcome is 5-year ACVDR measured at 12 months. Secondary outcomes include 6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12 months. Linear mixed-effects regression will estimate mean difference between groups for primary and secondary continuous outcomes. Economic cost-consequences analysis will be conducted using quality of life and health resource use information and routinely collected government health service use and medication data. A parallel process evaluation will investigate implementation of the intervention, uptake and outcomes.
DISCUSSION


ACCT will deliver a coproduced and person-centred, guideline level cardiovascular primary care intervention to a high need population with SMI. If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation. Trial registration ANZCTR Trial number: ACTRN12619001112156.",2020,"If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation.","['people with severe mental illness (SMI', 'people with severe mental illness in the primary care setting']",['coproduced assertive cardiac care intervention'],"['absolute CVD risk (ACVDR', '5-year ACVDR', '6-month ACVDR; and blood pressure, lipids, HbA1c, BMI, quality of life, physical activity, motivation to change health behaviour, medication adherence, alcohol use and hospitalisation at 6 and 12\u202fmonths']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.192142,"If successful, the intervention could lead to the reduction of the mortality gap and increase opportunities for meaningful social and economic participation.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Chondros', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics Unit, Faculty of Health, Australia.'}, {'ForeName': 'Yong Yi', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics Unit, Faculty of Health, Australia; School of Public Health, The University of Queensland, Australia; Policy and Epidemiology Group, Queensland Centre for Mental Health Research, Australia.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Gunn', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia; NorthWestern Mental Health, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Furler', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, Australia; Camden and Islington NHS Foundation Trust, NW1OPE, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Castle', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Davidson', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Jayaram', 'Affiliation': 'The Department of Psychiatry, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia; NorthWestern Mental Health, Melbourne, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Kenny', 'Affiliation': 'College of Science, Health and Engineering, La Trobe Rural Health School, Violet Vines Marshman Centre for Rural Health Research, La Trobe University, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Australia.'}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Morgan', 'Affiliation': 'Neuropsychiatric Epidemiology Research Unit, School of Population and Global Health, University of Western Australia, Australia; Centre for Clinical Research in Neuropsychiatry, Division of Psychiatry, University of Western Australia, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrap', 'Affiliation': 'Department of Physiology, University of Melbourne, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'McKenzie', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Potiriadis', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Konstancja', 'Initials': 'K', 'LastName': 'Densley', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Palmer', 'Affiliation': 'The Department of General Practice, Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Australia. Electronic address: v.palmer@unimelb.edu.au.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106143']
2056,32932394,Changes in Scleral Tonometry and Anterior Chamber Angle after Short-term Scleral Lens Wear.,"SIGNIFICANCE


Scleral lens wear can alter aqueous fluid and anterior chamber angle dynamics, leading to changes in intraocular pressure (IOP). However, there is limited information supporting this relationship between scleral lens wear, anterior chamber angle (ACA), and IOP changes in an black African population.
PURPOSE


The purpose of this study was to compare scleral IOP and ACA before, during, and after 4 hours of scleral lens wear in healthy neophyte scleral lens wearers from an black African population.
METHODS


This was a prospective study involving 20 eyes of 20 subjects with a mean ± standard deviation age of 28.7 ± 4.3 years. The study was divided into a screening and experimental phase. Scleral lenses from a diagnostic trial set were fit on a randomly selected eye. Scleral IOP was measured using a Schiotz tonometer (Winters, Jungingen, Germany) (weight, 7.5 g) on the superior-temporal sclera, and ACA was assessed using anterior segment optical coherence tomography on the temporal angle before scleral lens wear; at 10 minutes, 2 hours, and 4 hours during wear; and 10 minutes after scleral lens removal.
RESULTS


The mean ± standard deviation base curve of the scleral lens fit in the study eye was 43.4 ± 1.3 D with average tear reservoir thickness of 288.1 ± 122.0 μm at 4 hours. The mean scleral IOP before lens wear was 17.2 ± 3.5 mmHg, decreased to 16.4 ± 4.5 mmHg at 4 hours of scleral lens wear, and was 16.6 ± 3.5 mmHg 10 minutes after lens removal. The temporal ACA before scleral lens application was 43.0 ± 6.6° and varied during the 4 hours of scleral lens wear, ultimately increasing to 45.0 ± 5.4° at 10 minutes after scleral lens removal. The change in IOP and ACA was not statistically significant (F = 0.501, P = .74; and F = 2.399, P = .09, respectively).
CONCLUSIONS


Results suggest that 4 hours of nonfenestrated scleral lens wear did not have a significant impact on IOP or ACA in most of our study population.",2020,"The change in IOP and ACA was not statistically significant (F = 0.501, P = .74; and F = 2.399, P = .09, respectively).
","['healthy neophyte scleral lens wearers from an black African population', '20 eyes of 20 subjects with a mean ± standard deviation age of 28.7 ± 4.3 years']",['Scleral lenses'],"['mean scleral IOP', 'change in IOP and ACA', 'IOP or ACA', 'Scleral Tonometry and Anterior Chamber Angle', 'Scleral IOP', 'intraocular pressure (IOP']","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229238', 'cui_str': 'Structure of iridocorneal angle'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}]",20.0,0.0236254,"The change in IOP and ACA was not statistically significant (F = 0.501, P = .74; and F = 2.399, P = .09, respectively).
","[{'ForeName': 'Chukwuemeka Junior', 'Initials': 'CJ', 'LastName': 'Obinwanne', 'Affiliation': 'Cornea and Contact Lens Department, De Lens Family Eye and Vision Care Center, Abuja, Nigeria.'}, {'ForeName': 'Damian C', 'Initials': 'DC', 'LastName': 'Echendu', 'Affiliation': 'Cornea and Contact Lens Department, De Lens Family Eye and Vision Care Center, Abuja, Nigeria.'}, {'ForeName': 'Osazee', 'Initials': 'O', 'LastName': 'Agbonlahor', 'Affiliation': 'Cornea and Contact Lens Department, De Lens Family Eye and Vision Care Center, Abuja, Nigeria.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Dike', 'Affiliation': 'Cornea and Contact Lens Department, De Lens Family Eye and Vision Care Center, Abuja, Nigeria.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001568']
2057,32932396,Corneal Health during Three Months of Scleral Lens Wear.,"SIGNIFICANCE


This study evaluated the effects scleral lens wear has on corneal health using fluorometry and in vivo confocal microscopy. No subclinical changes on healthy corneas of young subjects were observed during 3 months of scleral lens wear.
PURPOSE


This study aimed to evaluate the effects 3 months of scleral lens wear has on the corneal epithelial barrier function, dendritic cell density, and nerve fiber morphology.
METHODS


Twenty-seven neophytes (mean [standard deviation] age, 21.4 [3.9] years) wore scleral lenses of a fluorosilicone acrylate material bilaterally (97 Dk, 15.6 to 16.0-mm diameter) for 3 months without overnight wear. Subjects were randomized to use either Addipak (n = 12) or PuriLens Plus (n = 15) during lens insertion. Measurements of corneal epithelial permeability to fluorescein were performed with automated scanning fluorophotometer (Fluorotron Master; Ocumetrics, Mountain View, CA) on the central cornea of the right eye and the temporal corneal periphery of the left eye. Images of the distributions of corneal nerve fibers and dendritic cells and nerve fibers were captured in vivo with a confocal laser scanning microscope (Heidelberg Retina Tomograph, Rostock Cornea Module; Heidelberg Engineering, Heidelberg, Germany) on the central and inferior peripheral cornea of the left eye. Corneal measurements and imaging were performed at baseline and after 1 and 3 months of lens wear.
RESULTS


The corneal permeability values in natural log, dendritic cell densities, and nerve fiber morphology did not significantly change from baseline to 1 and 3 months of lens wear, for both central and peripheral corneal regions (P > .05). Dendritic cell density at the inferior cornea was higher than the central cornea throughout the study (P < .001). No relationships were observed between each outcome measurements and the saline solution groups (P > .05).
CONCLUSIONS


Scleral lens wear for 3 months on healthy cornea of young subjects did not affect corneal epithelial barrier function, nerve fiber, and dendritic cell densities. Buffered and nonbuffered saline solutions impacted the corneal health in similar ways.",2020,Dendritic cell density at the inferior cornea was higher than the central cornea throughout the study (P < .001).,"['Twenty-seven neophytes (mean [standard deviation] age, 21.4 [3.9] years) wore scleral lenses of a fluorosilicone acrylate material bilaterally (97 Dk, 15.6 to 16.0-mm diameter) for 3 months without overnight wear']","['Addipak (n = 12) or PuriLens Plus', 'Buffered and nonbuffered saline solutions']","['corneal epithelial barrier function, dendritic cell density, and nerve fiber morphology', 'corneal permeability values in natural log, dendritic cell densities, and nerve fiber morphology', 'corneal health', 'Corneal Health', 'corneal epithelial permeability', 'corneal epithelial barrier function, nerve fiber, and dendritic cell densities', 'Dendritic cell density']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0101303', 'cui_str': 'acrylate'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0027749', 'cui_str': 'Nerve fiber'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0498456,Dendritic cell density at the inferior cornea was higher than the central cornea throughout the study (P < .001).,"[{'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Tse', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Yixiu', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Truong', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Meng C', 'Initials': 'MC', 'LastName': 'Lin', 'Affiliation': 'Clinical Research Center, School of Optometry, University of California, Berkeley, Berkeley, California.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001566']
2058,32933552,Effects of Licorice on clinical symptoms and laboratory signs in moderately ill patients with pneumonia from COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


We investigate the effects of Licorice (Glycyrrhiza glabra L.) root extract, an anti-inflammatory natural medicine, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in patients with confirmed COVID-19 that are moderately ill.
TRIAL DESIGN


This is a single-center, open-label, randomized, clinical trial with parallel-group design. This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran.
PARTICIPANTS


Both male and female patients with ≥18 years of age (≥ 35 kg of weight), admitted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas for treatment, screened for the following criteria.
INCLUSION CRITERIA


1. Confirmed diagnosis of SARS-CoV-2 infection (via polymerase chain reaction [PCR] and/or antibody test). 2. Presenting as moderate COVID-19 pneumonia (via chest computed tomography (CT) and/or X-ray) requiring hospitalization. 3. Hospitalized ≤48 hours. 4. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm.
EXCLUSION CRITERIA


1. Underlying diseases, including chronic heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders. 2. Severe and critical COVID-19 pneumonia. 3. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs. 4. Treatment with Investigational and antiviral therapy in a clinical study within one month before randomization. 5. History of allergy to Licorice. 6. Pregnancy and breastfeeding.
INTERVENTION AND COMPARATOR


Intervention group: The standard treatment regimen for COVID-19 along with a Licorice-based herbal preparation (D-Reglis ®, Irandarouk Pharmaceutical Company, Iran) at a dose of 760 mg three times a day for a period of seven days.
CONTROL GROUP


The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol for a period of seven days.
MAIN OUTCOMES


The recovery rate of clinical symptoms, including fever, dry cough, and tiredness, as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein, are evaluated as primary outcomes within seven days of randomization. Time to improvement of clinical and paraclinical features and length of stay in a hospital, along with the incidence of adverse reactions are also evaluated as the secondary outcomes within seven days of randomization.
RANDOMIZATION


An electronic table of random numbers will be used to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the simple randomization method.
BLINDING (MASKING)


This is an open-label trial without blinding and placebo control.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


A total of 60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group).
TRIAL STATUS


The protocol is Version 1.0, May 31, 2020. Recruitment began July 30, 2020, and is anticipated to be completed by October 30, 2020.
TRIAL REGISTRATION


This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is ""IRCT20200506047323N2"", https://www.irct.ir/trial/47990 . The registration date is 31 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Time to improvement of clinical and paraclinical features and length of stay in a hospital, along with the incidence of adverse reactions are also evaluated as the secondary outcomes within seven days of randomization.
","['Shahid Mohammadi Hospital, Bandar Abbas, Iran', 'patients with confirmed COVID-19 that are moderately ill', 'Both male and female patients with ≥18 years of age (≥ 35 kg of weight), admitted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas for treatment, screened for the following criteria', '60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group', 'moderately ill patients with pneumonia from COVID-19']","['warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs', 'placebo', 'Licorice (Glycyrrhiza glabra L.) root extract', 'Licorice', 'standard treatment regimen for COVID-19 along with a Licorice-based herbal preparation (D-Reglis ®, Irandarouk Pharmaceutical Company, Iran', 'Investigational and antiviral therapy', 'GROUP']","['recovery rate of clinical symptoms, including fever, dry cough, and tiredness, as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein', 'clinical symptoms and laboratory signs', 'Severe and critical COVID-19 pneumonia', 'chronic heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0026457', 'cui_str': 'Monoamine oxidase inhibitor'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017987', 'cui_str': 'Licorice'}, {'cui': 'C0697105', 'cui_str': 'Glycyrrhiza glabra'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0949854', 'cui_str': 'Plant Preparation'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0850149', 'cui_str': 'Dry cough'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1290386', 'cui_str': 'Chronic heart disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0040128', 'cui_str': 'Disorder of thyroid gland'}]",60.0,0.14235,"Time to improvement of clinical and paraclinical features and length of stay in a hospital, along with the incidence of adverse reactions are also evaluated as the secondary outcomes within seven days of randomization.
","[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Safa', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Hassani-Azad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farashahinejad', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Davoodian', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Dadvand', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Hassanipour', 'Affiliation': 'Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fathalipour', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. M.fathalipour@hums.ac.ir.'}]",Trials,['10.1186/s13063-020-04706-3']
2059,32946806,Failure to Improve Verbal Fluency with Transcranial Direct Current Stimulation.,"Previous studies in healthy populations have provided equivocal evidence whether the application of anodal transcranial direct current stimulation (tDCS) over the left prefrontal cortex (PFC) can improve performance in verbal fluency tasks. In this double-blind, randomised within-participant study, we investigated whether anodal tDCS over the left PFC improves verbal fluency performance relative to sham tDCS. Forty eight healthy native German speakers performed two verbal fluency tasks after having received 20 min of anodal or sham tDCS over the left PFC. During stimulation, participants performed a picture naming task, which was expected to increase neuronal activity in the targeted region. We found no modulation of verbal fluency performance following anodal tDCS, with virtually identical overall scores across tDCS conditions. Furthermore, initiation time (i.e., time to produce the first correct utterance) was not affected by tDCS. As an unexpected finding, picture naming latencies were significantly longer during anodal compared to sham tDCS. Yet, changes in the naming task were not predictive of performance changes in the fluency task. Overall, the current study found no evidence that verbal fluency performance in healthy speakers could be improved by excitatory stimulation of the left PFC. We argue that previously observed positive effects could be false positives and should be interpreted with caution. The findings from the current study thus cast further doubt on the utility of tDCS in enhancing cognitive performance in the healthy (young) brain.",2020,"We found no modulation of verbal fluency performance following anodal tDCS, with virtually identical overall scores across tDCS conditions.","['healthy speakers', 'Forty eight healthy native German speakers', 'healthy (young) brain', 'healthy populations']","['verbal fluency tasks after having received 20\u202fmin of anodal or sham tDCS', 'anodal transcranial direct current stimulation (tDCS', 'anodal tDCS', 'tDCS']","['cognitive performance', 'Verbal Fluency', 'verbal fluency tasks', 'picture naming latencies', 'neuronal activity', 'verbal fluency performance', 'Furthermore, initiation time (i.e., time to produce the first correct utterance']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",48.0,0.0992325,"We found no modulation of verbal fluency performance following anodal tDCS, with virtually identical overall scores across tDCS conditions.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Klaus', 'Affiliation': 'Lise Meitner Research Group Cognition and Plasticity, Max Planck Institute for Human Cognitive and Brain Sciences, Stephanstrasse 1A, 04103 Leipzig, Germany. Electronic address: j.klaus@uu.nl.'}, {'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Hartwigsen', 'Affiliation': 'Lise Meitner Research Group Cognition and Plasticity, Max Planck Institute for Human Cognitive and Brain Sciences, Stephanstrasse 1A, 04103 Leipzig, Germany.'}]",Neuroscience,['10.1016/j.neuroscience.2020.09.003']
2060,32946821,Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials.,"BACKGROUND


The DEPICT-1 and DEPICT-2 studies showed that dapagliflozin as an adjunct to insulin in individuals with inadequately controlled type 1 diabetes improved glycaemic control and bodyweight, without increase in risk of hypoglycaemia. We aimed to determine the effect of dapagliflozin on urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) using pooled data from the DEPICT studies.
METHODS


In this post-hoc analysis, we used data pooled from both DEPICT studies (DEPICT-1 ran from Nov 11, 2014, to Aug 25, 2017; DEPICT-2 ran from July 8, 2015, to April 18, 2018), in which participants were aged 18-75 years, with inadequately controlled type 1 diabetes and with a baseline UACR of at least 30 mg/g. In the DEPICT studies, participants were randomly assigned (1:1:1) to receive dapagliflozin (5 mg or 10 mg) or placebo all plus insulin, for 24 weeks, with a 28-week long-term extension (ie, 52 weeks in total). In this post-hoc analysis, we assessed the percentage change from baseline in UACR and in eGFR, up to 52 weeks. UACR, eGFR, and safety were assessed in all eligible participants who had received at least one dose of study drug. HbA 1c , bodyweight, and systolic blood pressure were assessed in all participants who received at least one dose of study drug during the first 24-week period, and who had a baseline and any post-baseline assessment for that parameter. The DEPICT trials were registered with ClinicalTrials.gov, NCT02268214 (DEPICT-1), NCT02460978 (DEPICT-2), and are now complete.
RESULTS


251 participants with albuminuria at baseline were included in this post-hoc analysis; of whom 80 (32%) had been randomly assigned to dapagliflozin 5 mg, 84 (33%) to dapagliflozin 10 mg, and 87 (35%) to placebo. Compared with placebo, treatment with both dapagliflozin doses improved UACR over 52 weeks. At week 52, mean difference in change from baseline versus placebo in UACR was -13·3% (95% CI -37·2 to 19·8) for dapagliflozin 5 mg and -31·1% (-49·9 to -5·2) for dapagliflozin 10 mg. No notable change from baseline was seen in eGFR, with a mean difference in change from baseline versus placebo of 3·27 mL/min per 1·73 m 2  (95% CI -0·92 to 7·45) for dapagliflozin 5 mg and 2·12 mL/min per 1·73 m 2  (-2·03 to 6·27) for dapagliflozin 10 mg. Similar proportions of participants in each treatment group had adverse events and serious adverse events, including hypoglycaemia and diabetic ketoacidosis; no new safety signals were identified in this population.
INTERPRETATION


Treatment with dapagliflozin resulted in UACR reduction, which might provide renoprotective benefits in individuals with type 1 diabetes and albuminuria. Dedicated prospective studies are needed to confirm these findings as prespecified endpoints.
FUNDING


AstraZeneca.",2020,"Similar proportions of participants in each treatment group had adverse events and serious adverse events, including hypoglycaemia and diabetic ketoacidosis; no new safety signals were identified in this population.
","['individuals with inadequately controlled type 1 diabetes', 'eligible participants who had received at least one dose of study drug', '251 participants with albuminuria at baseline were included in this post-hoc analysis; of whom 80 (32', 'individuals with type 1 diabetes and albuminuria', 'participants were aged 18-75 years, with inadequately controlled type 1 diabetes and with a baseline UACR of at least 30 mg/g', 'individuals with type 1 diabetes']","['placebo', 'placebo all plus insulin', 'dapagliflozin']","['urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR', 'HbA 1c , bodyweight, and systolic blood pressure', 'UACR', 'UACR reduction', 'hypoglycaemia and diabetic ketoacidosis; no new safety signals', 'adverse events and serious adverse events', 'UACR, eGFR, and safety']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",251.0,0.625792,"Similar proportions of participants in each treatment group had adverse events and serious adverse events, including hypoglycaemia and diabetic ketoacidosis; no new safety signals were identified in this population.
","[{'ForeName': 'Per-Henrik', 'Initials': 'PH', 'LastName': 'Groop', 'Affiliation': 'Abdominal Center, Nephrology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Helsinki, Finland; Folkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland; Department of Diabetes, Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'Jacob School of Medicine, State University of New York, Buffalo, NY, USA.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""Institute for Endocrinology and Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Gillard', 'Affiliation': 'Clinical and Experimental Endocrinology, UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Edelman', 'Affiliation': 'Department of Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Jendle', 'Affiliation': 'Institute of Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Markus F', 'Initials': 'MF', 'LastName': 'Scheerer', 'Affiliation': 'BioParmaceuticals Medical, AstraZeneca, Wedel, Germany.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Thoren', 'Affiliation': 'Late-stage Development Cardiovascular, Renal and Metabolism, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'Late-stage Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Repetto', 'Affiliation': 'Global Medical Affairs, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium. Electronic address: chantal.mathieu@uzleuven.be.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30280-1']
2061,32946820,"Metformin in women with type 2 diabetes in pregnancy (MiTy): a multicentre, international, randomised, placebo-controlled trial.","BACKGROUND


Although metformin is increasingly being used in women with type 2 diabetes during pregnancy, little data exist on the benefits and harms of metformin use on pregnancy outcomes in these women. We aimed to investigate the effects of the addition of metformin to a standard regimen of insulin on neonatal morbidity and mortality in pregnant women with type 2 diabetes.
METHODS


In this prospective, multicentre, international, randomised, parallel, double-masked, placebo-controlled trial, women with type 2 diabetes during pregnancy were randomly assigned from 25 centres in Canada and four in Australia to receive either metformin 1000 mg twice daily or placebo, added to insulin. Randomisation was done via a web-based computerised randomisation service and stratified by centre and pre-pregnancy BMI (<30 kg/m 2  or ≥30 kg/m 2 ) in a ratio of 1:1 using random block sizes of 4 and 6. Women were eligible if they had type 2 diabetes, were on insulin, had a singleton viable pregnancy, and were between 6 and 22 weeks plus 6 days' gestation. Participants were asked to check their fasting blood glucose level before the first meal of the day, before the last meal of the day, and 2 h after each meal. Insulin doses were adjusted aiming for identical glucose targets (fasting glucose <5·3 mmol/L [95 mg/dL], 2-h postprandial glucose <6·7 mmol/L [120 mg/dL]). Study visits were done monthly and patients were seen every 1-4 weeks as was needed for standard clinical care. At study visits blood pressure and bodyweight were measured; patients were asked about tolerance to their pills, any hospitalisations, insulin doses, and severe hypoglycaemia events; and glucometer readings were downloaded to the central coordinating centre. Participants, caregivers, and outcome assessors were masked to the intervention. The primary outcome was a composite of fetal and neonatal outcomes, for which we calculated the relative risk and 95% CI between groups, stratifying by site and BMI using a log-binomial regression model with an intention-to-treat analysis. Secondary outcomes included several relevant maternal and neonatal outcomes. The trial was registered with ClinicalTrials.gov, NCT01353391.
FINDINGS


Between May 25, 2011, and Oct 11, 2018, we randomly assigned 502 women, 253 (50%) to metformin and 249 (50%) to placebo. Complete data were available for 233 (92%) participants in the metformin group and 240 (96%) in the placebo group for the primary outcome. We found no significant difference in the primary composite neonatal outcome between the two groups (40% vs 40%; p=0·86; relative risk [RR] 1·02 [0·83 to 1·26]). Compared with women in the placebo group, metformin-treated women achieved better glycaemic control (HbA 1c  at 34 weeks' gestation 41·0 mmol/mol [SD 8·5] vs 43·2 mmol/mol [-10]; 5·90% vs 6·10%; p=0·015; mean glucose 6·05 [0·93] vs 6·27 [0·90]; difference -0·2 [-0·4 to 0·0]), required less insulin (1·1 units per kg per day vs 1·5 units per kg per day; difference -0·4 [95% CI -0·5 to -0·2]; p<0·0001), gained less weight (7·2 kg vs 9·0 kg; difference -1·8 [-2·7 to -0·9]; p<0·0001) and had fewer caesarean births (125 [53%] of 234 in the metformin group vs 148 [63%] of 236 in the placebo group; relative risk [RR] 0·85 [95% CI 0·73 to 0·99]; p=0·031). We found no significant difference between the groups in hypertensive disorders (55 [23%] in the metformin group vs 56 [23%] in the placebo group; p=0·93; RR 0·99 [0·72 to 1·35]). Compared with those in the placebo group, metformin-exposed infants weighed less (mean birthweight 3156 g [SD 742] vs 3375 g [742]; difference -218 [-353 to -82]; p=0·002), fewer were above the 97th centile for birthweight (20 [9%] in the metformin group vs 34 [15%] in the placebo group; RR 0·58 [0·34 to 0·97]; p=0·041), fewer weighed 4000 g or more at birth (28 [12%] in the metformin group vs 44 [19%] in the placebo group; RR 0·65 [0·43 to 0·99]; p=0·046), and metformin-exposed infants had reduced adiposity measures (mean sum of skinfolds 16·0 mm [SD 5·0] vs 17·4 [6·2] mm; difference -1·41 [-2·6 to -0·2]; p=0·024; mean neonatal fat mass 13·2 [SD 6·2] vs 14·6 [5·0]; p=0·017). 30 (13%) infants in the metformin group and 15 (7%) in the placebo group were small for gestational age (RR 1·96 [1·10 to 3·64]; p=0·026). We found no significant difference in the cord c-peptide between groups (673 pmol/L [435] in the metformin group vs 758 pmol/L [595] in the placebo group; p=0·10; ratio of means 0·88 [0·72 to 1·02]). The most common adverse event reported was gastrointestinal (38 events in the metformin group and 38 events in the placebo group).
INTERPRETATION


We found several maternal glycaemic and neonatal adiposity benefits in the metformin group. Along with reduced maternal weight gain and insulin dosage and improved glycaemic control, the lower adiposity and infant size measurements resulted in fewer large infants but a higher proportion of small-for-gestational-age infants. Understanding the implications of these effects on infants will be important to properly advise patients who are contemplating the use of metformin during pregnancy.
FUNDING


Canadian Institutes of Health Research, Lunenfeld-Tanenbaum Research Institute, University of Toronto.",2020,"The most common adverse event reported was gastrointestinal (38 events in the metformin group and 38 events in the placebo group).
","['0·85', 'women with type 2 diabetes during pregnancy', 'pregnant women with type 2 diabetes', 'group; RR 0·58', 'women with type 2 diabetes in pregnancy (MiTy', '0·34 to 0·97', 'women with type 2 diabetes during pregnancy were randomly assigned from 25 centres in Canada and four in Australia to receive either', 'group were small for gestational age (RR 1·96', ""Women were eligible if they had type 2 diabetes, were on insulin, had a singleton viable pregnancy, and were between 6 and 22 weeks plus 6 days' gestation""]","['insulin', 'metformin', 'placebo', 'metformin 1000 mg twice daily or placebo, added to insulin', 'Metformin']","['relative risk [RR', 'maternal weight gain and insulin dosage and improved glycaemic control, the lower adiposity and infant size measurements', 'composite of fetal and neonatal outcomes', 'adiposity measures', 'hypertensive disorders', 'neonatal morbidity and mortality', 'several relevant maternal and neonatal outcomes', 'fasting blood glucose level', 'several maternal glycaemic and neonatal adiposity benefits', 'mean neonatal fat mass 13·2', 'caesarean births', 'glycaemic control', '2-h postprandial glucose']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0404843', 'cui_str': 'Viable pregnancy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",502.0,0.606777,"The most common adverse event reported was gastrointestinal (38 events in the metformin group and 38 events in the placebo group).
","[{'ForeName': 'Denice S', 'Initials': 'DS', 'LastName': 'Feig', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada. Electronic address: d.feig@utoronto.ca.'}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Donovan', 'Affiliation': ""Cumming School of Medicine, Department of Medicine, Department of Obstetrics and Gynecology, University of Calgary, Calgary, AB, Canada; Alberta Children's Hospital Research Institute, Calgary, AB, Canada.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sanchez', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Asztalos', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Edmond A', 'Initials': 'EA', 'LastName': 'Ryan', 'Affiliation': 'University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Fantus', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Hutton', 'Affiliation': 'McMaster University Hamilton, ON, Canada.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'Armson', 'Affiliation': 'Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Lorraine L', 'Initials': 'LL', 'LastName': 'Lipscombe', 'Affiliation': ""Department of Medicine, University of Toronto, Toronto, ON, Canada; Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simmons', 'Affiliation': 'Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'Jon F R', 'Initials': 'JFR', 'LastName': 'Barrett', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Karanicolas', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada; Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Tobin', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'H David', 'Initials': 'HD', 'LastName': 'McIntyre', 'Affiliation': 'Mater Research, University of Queensland, South Brisbane, QLD, Australia.'}, {'ForeName': 'Simon Yu', 'Initials': 'SY', 'LastName': 'Tian', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medicine, University Health, Network, Toronto, ON, Canada.'}, {'ForeName': 'Kellie E', 'Initials': 'KE', 'LastName': 'Murphy', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada; Lunenfeld-Tanenbaum Research Institute, Toronto, ON, Canada; Sinai Health System, Mount Sinai Hospital, Toronto, ON, Canada; Department of Obstetrics and Gynecology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30310-7']
2062,32949780,Induction of LTD-like corticospinal plasticity by low-frequency rTMS depends on pre-stimulus phase of sensorimotor μ-rhythm.,"BACKGROUND


Neural oscillations reflect rapidly changing brain excitability states. We have demonstrated previously with EEG-triggered transcranial magnetic stimulation (TMS) of human motor cortex that the positive vs. negative peak of the sensorimotor μ-oscillation reflect corticospinal low-vs. high-excitability states. In vitro experiments showed that induction of long-term depression (LTD) by low-frequency stimulation depends on the postsynaptic excitability state.
OBJECTIVE/HYPOTHESIS


We tested the hypothesis that induction of LTD-like corticospinal plasticity in humans by 1 Hz repetitive TMS (rTMS) is enhanced when rTMS is synchronized with the low-excitability state, but decreased or even shifted towards long-term (LTP)-like plasticity when synchronized with the high-excitability state.
METHODS


We applied real-time EEG-triggered 1-Hz-rTMS (900 pulses) to the hand area of motor cortex in healthy subjects. In a randomized double-blind three-condition crossover design, pulses were synchronized to either the positive or negative peak of the sensorimotor μ-oscillation, or were applied at random phase (control). The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
RESULTS


1-Hz-rTMS at random phase resulted in a trend towards LTD-like corticospinal plasticity. RTMS in the positive peak condition (i.e., the low-excitability state) induced significant LTD-like plasticity. RTMS in the negative peak condition (i.e., the high-excitability state) showed a trend towards LTP-like plasticity, which was significantly different from the other two conditions.
CONCLUSION


The level of corticospinal depolarization reflected by phase of the μ-oscillation determines the degree of corticospinal plasticity induced by low-frequency rTMS, a finding that may guide future personalized therapeutic stimulation.",2020,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
",['healthy subjects'],"['Hz repetitive TMS (rTMS', '1-Hz-rTMS', 'EEG-triggered transcranial magnetic stimulation (TMS']","['amplitude of motor evoked potentials', 'induction of long-term depression (LTD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.095784,"The amplitude of motor evoked potentials was recorded as an index of corticospinal excitability before and after 1-Hz-rTMS.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baur', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Galevska', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Cohen', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ziemann', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany. Electronic address: ulf.ziemann@uni-tuebingen.de.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zrenner', 'Affiliation': 'Department of Neurology & Stroke, University of Tübingen, Germany; Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.09.005']
2063,32949942,The effect of individualized education with support on breast cancer patients' anxiety and depression during radiation therapy: A pilot study.,"PURPOSE


This study was undertaken to determine the effects of individualized education with support intervention on breast cancer patients' anxiety and depression while undergoing radiation therapy (RT). Moreover, the intervention was assessed for its feasibility in the context of Pakistan.
METHODS


A quasi-experimental design was used to conduct this study in RT department of a public hospital in Karachi. A total of 61 breast cancer patients receiving radiation as adjuvant therapy participated in the study. The experimental group (n = 31) received individualized education with support in the form of face-to-face sessions and information booklet prior to the commencement of RT. In addition, the nurse remained available for the consultation during the RT sessions and on telephone throughout the RT period. However, the control group received only information booklet. Patients' anxiety and depression were measured in both of the groups before the commencement of RT, and at the completion of RT by using the Aga Khan University Anxiety and Depression Scale (AKUADS).
RESULTS


A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test. The overall mean anxiety and depression scores of the control group showed no significant difference (p = 0.187). The effect size of the intervention was large (Cohen's d = 2.5).
CONCLUSION


The intervention was effective in reducing anxiety and depression among breast cancer patients receiving RT. Replication of the study on a larger scale in multiple settings on other cancer patients is recommended.",2020,A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test.,"['61 breast cancer patients receiving radiation as adjuvant therapy participated in the study', ""breast cancer patients' anxiety and depression during radiation therapy"", ""breast cancer patients' anxiety and depression while undergoing radiation therapy (RT"", 'RT department of a public hospital in Karachi', 'breast cancer patients receiving RT']","['individualized education', 'individualized education with support intervention', 'individualized education with support in the form of face-to-face sessions and information booklet prior to the commencement of RT']","['overall mean anxiety and depression scores', 'anxiety and depression']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0131595,A significant reduction was found in the overall mean anxiety and depression scores of the experimental group (p = 0.000) from pre-test to post-test.,"[{'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Zaheer', 'Affiliation': 'Institute of Nursing, Combined Military Hospital (CMH) Lahore Medical College, Pakistan. Electronic address: shaziazaheer911@gmail.com.'}, {'ForeName': 'Raisa B', 'Initials': 'RB', 'LastName': 'Gul', 'Affiliation': 'Shifa Tameer-e-Millat University, Shifa College of Nursing, Islamabad, Pakistan.'}, {'ForeName': 'Shireen S', 'Initials': 'SS', 'LastName': 'Bhamani', 'Affiliation': 'Aga Khan University School of Nursing and Midwifery, Karachi, Pakistan.'}, {'ForeName': 'Muhammad A', 'Initials': 'MA', 'LastName': 'Memon', 'Affiliation': 'Atomic Energy Medical Center, Jinnah Post Graduate Medical Center, Karachi, Pakistan.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101826']
2064,32949954,A randomized control trial of meditation compared to music listening to improve cognitive function for breast cancer survivors: Feasibility and acceptability.,"BACKGROUND


and Purpose: Many breast cancer survivors (BCS) experience persistent cognitive and psychological changes associated with their cancer and/or treatment and that have limited treatment options. Therefore, the purpose of this study was to explore the feasibility and effects of a Kirtan Kriya meditation (KK) intervention on cognitive and psychological symptoms compared to an attention control condition, classical music listening (ML), in BCS.
MATERIALS AND METHODS


A randomized control trial design was used. Participants completed eight-week interventions. Cognitive function and psychological symptoms were measured at baseline and post-intervention. Mixed analysis of variance models were examined for all cognitive and psychological outcomes.
RESULTS


27 BCS completed the study. Intervention adherence was 88%. Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's < 0.01). There were no significant group by time effects for cognitive and psychological outcomes, except stress. The ML group reported lower stress at time 2 (p < 0.05).
CONCLUSION


KK and ML are feasible, acceptable, and cost-effective interventions that may be beneficial for survivors' cognition and psychological symptoms. Both interventions were easy to learn, low cost, and required just 12 min/day. Meditation or music listening could offer providers evidence-based suggestions to BCS experiencing cognitive symptoms.
CLINICAL TRIALS REGISTRATION NUMBER


NCT03696056.",2020,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ",['breast cancer survivors'],"['Meditation or music listening', 'music listening', 'classical music listening (ML', 'Kirtan Kriya meditation (KK) intervention', 'meditation']","['cognitive and psychological symptoms', 'time effects for cognitive and psychological outcomes, except stress', ""perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's"", 'cognitive function', 'Cognitive function and psychological symptoms', 'Intervention adherence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.062006,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Henneghan', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Oncology, 1601 Trinity St, Austin, TX, 78712, USA. Electronic address: ahenneghan@utexas.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Harrison', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Inselmann', 'Affiliation': 'Cancer Rehab and Integrative Medicine, 4130 Spicewood Springs Rd. Ste. 100, Austin, TX, 78759, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Fico', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schafer', 'Affiliation': 'The University of Texas at Austin, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Division of Clinical Cancer Genomics City of Hope, 1500 E. Duarte Road, Duarte, CA, 91010, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Patt', 'Affiliation': 'Texas Oncology, The University of Texas at Austin, Department of Oncology, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Diagnostic Medicine, 1601 Trinity St, Austin, TX, 78712, USA.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101228']
2065,32949957,The long-term outcomes of tobacco control strategies based on the cognitive intervention for smoking cessation in COPD patients.,"OBJECTIVE


To evaluate the long-term efficacy of tobacco control strategies based on cognitive intervention for smoking cessation in chronic obstructive pulmonary disease (COPD) patients, and to provide basis for clinical practice.
MATERIALS AND METHODS


102 COPD patients with a long-term history of smoking from the outpatient clinic were recruited in the study. These smokers were randomly divided into intervention group and control group. The intervention group received a cognitive intervention containing individual consultation, telephone follow-ups and self-help materials, etc. The prevalence of quitting smoking, acute exacerbation (AE), lung function and survival were compared in the groups in 10 years.
RESULTS


There were significant differences between the intervention group and the control group in the rate of persistent quitting smoking in half a year (17.6% vs 3.9%) (P < 0.05), the rate of quitting smoking at the 6th month (58.8% vs 33.3%) (P < 0.05). After 3 months (P < 0.01) and 6 months (P < 0.01), the difference in body weight between the intervention group and the control group was statistically significant. Intervention-group patients had fewer AE per year (P < 0.01) and higher FEV1/FVC ratio (P < 0.01) after 5-year and 10-year follow-up. Besides, the FEV1% predicted in the intervention patients was higher than that in control group after 10-year follow-up. The ages of patients in the death group were greater than those in the survival group. Death-group patients had longer smoking times, higher smoking index, and later onset of COPD symptoms. Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P < 0.01). During 10-year follow-up, 30 patient deaths were recorded (the control group: n = 48; 19 deaths, and intervention group: n = 46; 11 deaths), and patients in the control group had lower survival than those in the intervention group. (P < 0.05).
CONCLUSION


The method of quitting smoking based on cognitive intervention is an effective way for COPD patients to quit smoking successfully. Quitting smoking can slower deterioration in lung function and improve the survival of COPD patients.
CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR2000031239 (Chinese clinical trial registry).",2020,Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P ,"['102 COPD patients with a long-term history of smoking from the outpatient clinic were recruited in the study', 'COPD patients', 'chronic obstructive pulmonary disease (COPD) patients']","['tobacco control strategies', 'cognitive intervention containing individual consultation, telephone follow-ups and self-help materials, etc', 'quitting smoking based on cognitive intervention', 'cognitive intervention']","['prevalence of quitting smoking, acute exacerbation (AE), lung function and survival', 'longer smoking times, higher smoking index, and later onset of COPD symptoms', 'higher FEV1/FVC ratio', 'body weight', 'rate of quitting smoking', 'rate of persistent quitting smoking', 'lower survival', 'FEV1/FVC ratio']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",102.0,0.0291403,Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P ,"[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Lei', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: leisi0831@csu.edu.cn.'}, {'ForeName': 'Meilei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 593194666@qq.com.'}, {'ForeName': 'Wenbing', 'Initials': 'W', 'LastName': 'Duan', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 837216794@qq.com.'}, {'ForeName': 'Caiqin', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 1974546139@qq.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: pingchen0731@csu.edu.cn.'}, {'ForeName': 'Shangjie', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: wushangjie@csu.edu.cn.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106155']
2066,32949986,Underuse of oral anticoagulants in privately insured patients with atrial fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib).,"BACKGROUND


Many studies showing underuse of oral anticoagulants (OACs) in patients with atrial fibrillation (AF) predated the advent of the non-vitamin K antagonist OACs. We retrospectively examined use of OACs in a large commercially insured population.
METHODS


Administrative claims data from 4 research partners participating in FDA-Catalyst, a program of the Sentinel Initiative, were queried in September 2017. Patients were included if they were ≥30 years old with ≥365 days of medical/pharmacy coverage, and had ≥2 diagnosis codes for AF, a CHA 2 DS 2 -VASc score ≥2, absence of contraindications to OAC use, and no evidence of OAC use in the 365 days before the index AF diagnosis. The main outcome measures of the current analysis were rates of OAC use in the prior 12 months of cohort identification and factors associated with non-use.
RESULTS


A total of 197,806 AF patients met the eligibility criteria prior to assessment of OAC treatment. Of these, 179,580 (91%) patients were ≥65 years old and 73,286 (37%) patients were ≥80 years old. Half of the patients (98,903) were randomized to the early intervention arm in the IMPACT-AFib trial and constitute the cohort for this analysis. Of these, 32,295 (33%) had no evidence of OAC use in the prior 12 months. Compared with patients with evidence of OAC use in the prior 12 months, patients without OAC use were more likely to be ≥80 years old, women, and have a history of anemia (51% vs 47%) and less likely to have diabetes (41% vs 44%), history of stroke or TIA (15% vs 19%), and history of heart failure (39% vs 48%).
CONCLUSIONS


Despite a high risk of stroke, one-third of privately insured patients with AF and no obvious contraindications to an OAC were not treated with an OAC. There is an unmet need for evidence-based interventions that could lead to greater use of OACs in patients with AF at risk for stroke.",2020,"Half of the patients (98,903) were randomized to the early intervention arm in the IMPACT-AFib trial and constitute the cohort for this analysis.","['Administrative claims data from 4 research partners participating in FDA-Catalyst, a program of the Sentinel Initiative, were queried in September 2017', 'patients with Atrial Fibrillation (IMPACT-AFib', '197,806 AF patients met the eligibility criteria prior to assessment of OAC treatment', '179,580 (91%) patients were ≥65 years old and 73,286 (37%) patients were ≥80 years old', 'patients with AF at risk for stroke', 'patients with atrial fibrillation (AF', 'Patients were included if they were ≥30 years old with ≥365 days of medical/pharmacy coverage, and had ≥2 diagnosis codes for AF, a CHA 2 DS 2 -VASc score ≥2, absence of contraindications to OAC use, and no evidence of OAC use in the 365 days before the index AF diagnosis', 'privately insured patients with atrial fibrillation', 'Half of the patients (98,903']","['oral anticoagulants (OACs', 'OACs', 'oral AntiCoagulanTs', 'oral anticoagulants']","['rates of OAC use', 'history of anemia', 'history of heart failure', 'history of stroke or TIA']","[{'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0559154', 'cui_str': 'H/O: anemia'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}]",197806.0,0.0480647,"Half of the patients (98,903) were randomized to the early intervention arm in the IMPACT-AFib trial and constitute the cohort for this analysis.","[{'ForeName': 'Sana M', 'Initials': 'SM', 'LastName': 'Al-Khatib', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address: alkha001@mc.duke.edu.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Pokorney', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'HealthCore, Inc., Wilmington, DE.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Garcia', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'US Food and Drug Administration, Silver Spring, MD.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Goldsack', 'Affiliation': 'The Clinical Trials Transformation Initiative, Durham, NC.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Harkins', 'Affiliation': 'Humana Healthcare Research, Louisville, KY.'}, {'ForeName': 'Noelle M', 'Initials': 'NM', 'LastName': 'Cocoros', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Lin', 'Affiliation': 'OptumInsight Life Sciences, Boston, MA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Lipowicz', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'McCall', 'Affiliation': 'Rowan Tree Perspectives Consulting, Murrieta, CA.'}, {'ForeName': 'Vinit', 'Initials': 'V', 'LastName': 'Nair', 'Affiliation': 'Humana Healthcare Research, Louisville, KY.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Parlett', 'Affiliation': 'HealthCore, Inc., Wilmington, DE.'}, {'ForeName': 'Cheryl N', 'Initials': 'CN', 'LastName': 'McMahill-Walraven', 'Affiliation': 'Aetna, Inc., Blue Bell, PA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Platt', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2020.07.012']
2067,32952904,Ultrasound-Guided Versus Anatomic Landmark-Guided Steroid Injection of the Subacromial Bursa in the Management of Subacromial Impingement: A Systematic Review of Randomised Control Studies.,"This study is a systematic review of prospective randomised control studies comparing ultrasound-guided steroid injection of the subacromial space with anatomic landmark-guided injection in the treatment of subacromial impingement to determine if there is any difference in pain relief and functional outcome. Mesh terms and free-text words search of electronic databases, reference list of identified studies and grey literature was performed using the PICO format. All identified papers were sifted sequentially by title, abstract and review of full text articles. Four papers qualified and were included in the review and analysis. The total number of patients in the studies was 234 patients with 117 patients randomised to each of landmark-guided and ultrasound-guided injection groups. There was no statistically significant difference in VAS pain scores ( P  = 0.67), SDQ scores ( P  = 0.43), SPADI disability score ( P  = 0.17) and functional outcomes scores ( P  = 0.09) at 4 to 6 weeks when USS-guided subacromial steroid injection was compared with landmark-guided injection. SPADI pain scores ( P  = 0.02) demonstrates significant reduction in favour of landmark-guided injection. There was low to moderate risk of bias. In conclusion, ultrasound-guided subacromial steroid injection does not offer any statistically significant clinical improvement over landmark-guided injection in adults with subacromial impingement.",2020,"There was no statistically significant difference in VAS pain scores ( P  = 0.67), SDQ scores ( P  = 0.43), SPADI disability score ( P  = 0.17) and functional outcomes scores ( P  = 0.09) at 4 to 6 weeks when USS-guided subacromial steroid injection was compared with landmark-guided injection.","['adults with subacromial impingement', 'Subacromial Impingement', '234 patients with 117 patients']","['ultrasound-guided subacromial steroid injection', 'ultrasound-guided steroid injection of the subacromial space with anatomic landmark-guided injection', 'Ultrasound-Guided Versus Anatomic Landmark-Guided Steroid Injection of the Subacromial Bursa']","['functional outcomes scores', 'pain relief and functional outcome', 'SDQ scores', 'SPADI disability score', 'VAS pain scores', 'SPADI pain scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4302319', 'cui_str': 'Subacromial steroid injection'}, {'cui': 'C4305575', 'cui_str': 'Ultrasonography guided steroid injection'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C3178884', 'cui_str': 'Anatomic Landmarks'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0224792', 'cui_str': 'Structure of subacromial bursa'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",234.0,0.0631745,"There was no statistically significant difference in VAS pain scores ( P  = 0.67), SDQ scores ( P  = 0.43), SPADI disability score ( P  = 0.17) and functional outcomes scores ( P  = 0.09) at 4 to 6 weeks when USS-guided subacromial steroid injection was compared with landmark-guided injection.","[{'ForeName': 'Charles I', 'Initials': 'CI', 'LastName': 'Ayekoloye', 'Affiliation': 'Department of Orthopaedics, Oaklands Hospital, 19 Lancaster Road, Salford, M6 8AQ UK.'}, {'ForeName': 'Osondu', 'Initials': 'O', 'LastName': 'Nwangwu', 'Affiliation': 'Department of Orthopaedics, Luton & Dunstable Hospital, Bedfordshire, UK.'}]",Indian journal of orthopaedics,['10.1007/s43465-020-00148-w']
2068,32952920,Zoledronic Acid Attenuates Early Bone Loss at Forearm in Patients with Acute Spinal Cord Injury.,"Study design


Randomized controlled trial.
Objectives


To study the magnitude of bone loss at forearm in persons with acute spinal cord injury (SCI) & the effect of early administration of Zoledronic acid on its' prevention.
Settings


Sawai Man Singh Medical College, Jaipur, India.
Methods


Sixty patients with acute SCI were randomized either to receive standard medical and nursing care or Zoledronic acid infusion in combination with standard medical and nursing care. Areal bone mineral density (aBMD) was measured at the forearm (radius + ulna) once patients were medically stable using Dual Energy X-Ray Absorptiometry (DXA) at baseline and at 3, 6 and 12 months.
Results


Significant differences in aBMD was found between the control & Zoledronic acid group at 1/3 forearm (- 0.064; 95% CI - 0.092 to - 0.036,  p  = 0.001), mid forearm (- 0.059; 95% CI - 0.084 to - 0.034,  p  = 0.001), UD forearm (- 0.048; 95% CI - 0.097 to 0.001,  p  = 0.016) and total forearm (- 0.048; 95% CI - 0.088 to - 0.008,  p  = 0.021) at 1 year in the paraplegic patients with SCI. Similar significant difference was also observed at 1/3 forearm (- 0.046; 95% CI - 0.073 to - 0.019,  p  = 0.002), mid forearm (- 0.063; 95% CI - 0.088 to - 0.037,  p  < 0.0001), UD forearm (- 0.084; 95% CI - 0.101 to - 0.067,  p  < 0.0001) and total forearm (- 0.115; 95% CI - 0.132 to - 0.097,  p  < 0.0001) respectively at 1 year in the quadriplegic patients with SCI. Significant differences in aBMD between the groups at 6 months post infusion was also observed at these sites in quadriplegic patients. [1/3 forearm - 0.022; 95% CI - 0.039 to - 0.005;  p  = 0.015, Mid forearm - 0.023; 95% CI - 0.042 to - 0.004;  p  = 0.019, UD forearm - 0.041; 95% CI - 0.055 to - 0.027;  p  < 0.0001 and Total forearm - 0.049; 95%CI - 0.062 to - 0.036;  p  < 0.0001]. Bone loss was reduced in the Zoledronic acid treated group compared to the standard treatment group in both paraplegic and quadriplegic patients.
Conclusion


Single dose of 5mg intravenous Zoledronic acid is an effective treatment in preventing bone loss at the forearm for 12 months following acute spinal cord injury.",2020,"Bone loss was reduced in the Zoledronic acid treated group compared to the standard treatment group in both paraplegic and quadriplegic patients.
","['Settings\n\n\nSawai Man Singh Medical College,\xa0Jaipur, India', 'Patients with Acute Spinal Cord Injury', 'persons with acute spinal cord injury (SCI', 'Sixty patients with acute SCI']","['Zoledronic acid', 'standard medical and nursing care or Zoledronic acid infusion in combination with standard medical and nursing care', 'Zoledronic Acid']","['Areal bone mineral density (aBMD', 'aBMD', 'bone loss', 'total forearm', 'Bone loss', 'UD forearm']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}]",60.0,0.244719,"Bone loss was reduced in the Zoledronic acid treated group compared to the standard treatment group in both paraplegic and quadriplegic patients.
","[{'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Goenka', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Sawai Man Singh Medical College, Jaipur, Rajasthan 3020004 India.'}, {'ForeName': 'Satyaranjan', 'Initials': 'S', 'LastName': 'Sethi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Sawai Man Singh Medical College, Jaipur, Rajasthan 3020004 India.'}]",Indian journal of orthopaedics,['10.1007/s43465-020-00158-8']
2069,32925713,Research based on the core pathogenesis in the treatment according to traditional Chinese medicine syndrome differentiation for heart failure with normal ejection fraction.,"BACKGROUND


The incidence of heart failure with normal ejection fraction (HFNEF) is increasing yearly, accounting for approximately half of all heart failure cases. Even after standardized treatment, the patient's prognosis is not good. Therefore, it is necessary to explore new treatment methods for HFNEF. Yangyin Shuxin Decoction, a traditional Chinese medicine prescription from our clinical experience in the treatment of HFNEF, has a potential cardioprotective effect. Preliminary clinical trials have shown that this prescription can improve the quality of life of HFNEF. This prompted us to use more objective indicators to further evaluate whether Yangyin Shuxin Decoction can improve the exercise capacity in HENEF patients.
METHODS


This is a single-center parallel randomized controlled trial. The 64 patients who met the inclusion criteria were from the Cardiovascular Clinic. They will be randomly assigned to the treatment group (Yangying Shuxin Decoction combined with standard treatment) or the control group (standard treatment) according to the ratio of 1:1. The course of treatment will be 2 weeks. Both groups were interviewed at the following time points: of at enrollment (V1), and week 2 (V2), week 4 (V3), week 8 (V4), and week 12 (V5) after enrollment. The primary indicator is the peak oxygen consumption (Peak VO2) of the cardiopulmonary exercise test (CPET). Secondary indicators include CPET indicators such as anaerobic threshold oxygen consumption, carbon dioxide ventilation equivalent slope, echocardiographic indicators such as the ratio of mitral peak velocity of early filling to early diastolic mitral annular velocity(E/e'), left atrial volume index (LAVI), left ventricular mass index (LVMI), the peak velocity of tricuspid regurgitation (TR), B-type natriuretic peptide (BNP), New York Heart Association (NYHA) cardiac function grading, and so on. These indicators will be used to evaluate the effect of Yangyin Shuxin Decoction on exercise capacity in patients with HFNEF.
DISCUSSION


At present, it is unclear whether the exercise capacity can be maintained after long-term use of Yangyin Shuxin Decoction. In this study, we will evaluate whether Yangyin Shuxin Decoction can improve the exercise capacity and quality of life of patients with HFNEF. This will provide an objective basis for the therapeutic effect of traditional Chinese medicine on HFNEF.
TRIAL REGISTRATION


This study protocol has been listed in the Chinese Clinical Trial Registry (registration number: ChiCTR-IOR-17014206, http://www.chictr.org.cn/showproj.aspx?proj=24304) on December 28, 2017.",2020,"Yangyin Shuxin Decoction, a traditional Chinese medicine prescription from our clinical experience in the treatment of HFNEF, has a potential cardioprotective effect.","['HENEF patients', '64 patients who met the inclusion criteria were from the Cardiovascular Clinic', 'patients with HFNEF']","['Shuxin Decoction combined with standard treatment', 'Yangyin Shuxin Decoction']","[""CPET indicators such as anaerobic threshold oxygen consumption, carbon dioxide ventilation equivalent slope, echocardiographic indicators such as the ratio of mitral peak velocity of early filling to early diastolic mitral annular velocity(E/e'), left atrial volume index (LAVI), left ventricular mass index (LVMI), the peak velocity of tricuspid regurgitation (TR), B-type natriuretic peptide (BNP), New York Heart Association (NYHA) cardiac function grading, and so on"", 'quality of life of HFNEF', 'exercise capacity', 'peak oxygen consumption (Peak VO2) of the cardiopulmonary exercise test (CPET', 'exercise capacity and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451631', 'cui_str': 'Cardiovascular clinic'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0428784', 'cui_str': 'Peak velocity of tricuspid regurgitation'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}]",,0.0650982,"Yangyin Shuxin Decoction, a traditional Chinese medicine prescription from our clinical experience in the treatment of HFNEF, has a potential cardioprotective effect.","[{'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Xianliang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Jingyuan', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021663']
2070,32925729,Femoral nerve block versus obturator nerve block for pain management after total knee replacement: A randomized controlled trial protocol.,"BACKGROUND


Several studies reported short-term analgesic efficacy of obturator nerve block (ONB), as in comparison with the femoral nerve block (FNB) in the treatment of postoperative pain after the total knee replacement (TKR). The optimal method remains under debate. The purpose of our current work is to compare the safety and efficacy of FNB and ONB for postoperative analgesia after TKR.
METHODS


This prospective, randomized, and controlled study was performed from January 2018 to December 2019. It was authorized via the Institutional Review Committee in NO.971 Hospital of the People's Liberation Army Navy (2019-PLAN-132).Two hundred patients were divided randomly into 2 groups, the control group (n = 100) and study group (n = 100). The experimental group received FNB and control groups received ONB. Primary outcome included pain at different time point (Visual Analogue Scale score of anterior knee pain at rest and in motion). The Visual Analogue Scale scores were marked by patients themselves on a paper with a graduated line starting at 0 (no pain) and ending at 10 (the most painful). Opioid consumption was converted to equivalents of oral morphine uniformly for statistical analysis. Secondary outcomes included the knee range of motion, the hospital stay length as well as the postoperative complications such as pulmonary embolism and deep vein thrombosis.
RESULTS


Table 1 will show the clinical outcomes between the 2 groups.
CONCLUSION


This trial would provide an evidence for the use of different types of peripheral nerve blocks in TKR.",2020,"Secondary outcomes included the knee range of motion, the hospital stay length as well as the postoperative complications such as pulmonary embolism and deep vein thrombosis.
","[""NO.971 Hospital of the People's Liberation Army Navy (2019-PLAN-132).Two hundred patients"", 'January 2018 to December 2019', 'pain management after total knee replacement']","['FNB and control groups received ONB', 'obturator nerve block (ONB', 'FNB and ONB', 'Femoral nerve block versus obturator nerve block']","['Opioid consumption', 'knee range of motion, the hospital stay length as well as the postoperative complications such as pulmonary embolism and deep vein thrombosis', 'pain at different time point (Visual Analogue Scale score of anterior knee pain at rest and in motion', 'Visual Analogue Scale scores']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0394741', 'cui_str': 'Local anesthetic obturator nerve block'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",,0.0884248,"Secondary outcomes included the knee range of motion, the hospital stay length as well as the postoperative complications such as pulmonary embolism and deep vein thrombosis.
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, NO.971 Hospital of the People's Liberation Army Navy, Shangdong, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Fuheng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021956']
2071,32931978,"Outcomes of a new slowly resorbable biosynthetic mesh (Phasix™) in potentially contaminated incisional hernias: A prospective, multi-center, single-arm trial.","BACKGROUND


Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair.
MATERIALS AND METHODS


A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm 2  were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair.
RESULTS


In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences.
CONCLUSION


Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.",2020,"No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites.","['patients with a Ventral Hernia Working Group Grade 3 hernia', 'Patients aged ≥ 18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included', '84 patients were treated with Phasix™ Mesh', 'patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair', 'These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula', 'potentially contaminated incisional hernias', '15 hospitals across Europe']","['new slowly resorbable biosynthetic mesh (Phasix™', 'Phasix™ Mesh', 'new resorbable biosynthetic mesh (Phasix™']","['hernia recurrences', 'rate of resorption', 'acceptable postoperative surgical site occurrence rates', 'rate of surgical site occurrences (SSO), including infections, that required intervention until 3 months after repair', 'recurrence rate', 'quality of life', 'surgical site occurrence development', '32 surgical site occurrences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0342971', 'cui_str': 'Repair of incisional hernia'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",84.0,0.180861,"No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites.","[{'ForeName': 'Mathilde Mj', 'Initials': 'MM', 'LastName': 'van Rooijen', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands. Electronic address: m.vanrooijen@erasmusmc.nl.'}, {'ForeName': 'An P', 'Initials': 'AP', 'LastName': 'Jairam', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Tollens', 'Affiliation': 'Imelda Hospital, Department of General Surgery, Bonheiden, Belgium.'}, {'ForeName': 'Lars N', 'Initials': 'LN', 'LastName': 'Jørgensen', 'Affiliation': 'University of Copenhagen, Bispebjerg Hospital, Department of Surgery, Copenhagen, Denmark.'}, {'ForeName': 'Tammo S', 'Initials': 'TS', 'LastName': 'de Vries Reilingh', 'Affiliation': 'Elkerliek Hospital, Department of Surgery, Helmond, The Netherlands.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Piessen', 'Affiliation': 'University Hospital Lille, Department of Surgery, Lille, France.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Köckerling', 'Affiliation': 'Vivantes Klinikum Spandau, Department of Surgery, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miserez', 'Affiliation': 'University Hospital Leuven, Department of Abdominal Surgery, Leuven, Belgium.'}, {'ForeName': 'Alastair Cj', 'Initials': 'AC', 'LastName': 'Windsor', 'Affiliation': 'University College London Hospital, Department of Colorectal Surgery, London, United Kingdom.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Berrevoet', 'Affiliation': 'University Hospital Ghent, Department of General and Hepatobiliary Surgery, Ghent, Belgium.'}, {'ForeName': 'René H', 'Initials': 'RH', 'LastName': 'Fortelny', 'Affiliation': 'Wilhelminenhospital, Department of General, Visceral and Oncologic Surgery, Vienna, Austria.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Dousset', 'Affiliation': 'Hôpital Cochin, Department of Digestive, Hepatobiliary and Endocrine Surgery, Paris, France.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Woeste', 'Affiliation': 'Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt Am Main, Germany.'}, {'ForeName': 'Henderik L', 'Initials': 'HL', 'LastName': 'van Westreenen', 'Affiliation': 'Isala Zwolle, Department of Surgery, Zwolle, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Gossetti', 'Affiliation': 'Università di Roma Sapienza, Rome, Italy.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lange', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands; IJsselland Ziekenhuis, Department of Surgery, Capelle Aan Den Ijssel, The Netherlands.'}, {'ForeName': 'Geert Wm', 'Initials': 'GW', 'LastName': 'Tetteroo', 'Affiliation': 'IJsselland Ziekenhuis, Department of Surgery, Capelle Aan Den Ijssel, The Netherlands.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Chirurgische Praxis Cottbus, Cottbus Area, Germany.'}, {'ForeName': 'Leonard F', 'Initials': 'LF', 'LastName': 'Kroese', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Jeekel', 'Affiliation': 'Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.053']
2072,32934794,Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial.,"Background:  Delirium is a common and serious complication of major surgery for older adults. Postoperative social and behavioral support (e.g., early mobilization, mealtime assistance) may reduce the incidence and impact of delirium, and these efforts are possible with proactive patient-care programs. This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  Methods:  This will be a randomized, controlled, factorial pilot trial at a large academic medical center. High-risk, non-cardiac surgery patients (≥70 years old) will be recruited. Patients will be allocated to a usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP- and family-based system (n=15). The primary outcome will be the presence of delirium, defined by positive long-form Confusion Assessment Method screening. Secondary outcomes will include additional HELP- and family-based performance metrics along with various neurocognitive and clinical recovery measures. Exploratory outcomes include the incidence of positive family-based delirium assessments post-discharge, 36-item Short Form Survey, PROMIS Cognitive Function Abilities Subset 4a, and 30-day readmission rates.  Ethics and dissemination:  This trial has received approval by the University of Michigan Medical Institutional Review Board (IRBMED). Dissemination plans include presentation at scientific conferences, publication in medical journals, and distribution via educational and news media.  Registration:  ClinicalTrials.gov Identifier NCT04007523, registered on 7/3/2019.",2019,"This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  ","['older adults', 'patient-care programs and family members for high-risk patients', 'High-risk, non-cardiac surgery patients (≥70 years old']","['usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP- and family-based system']","['incidence of positive family-based delirium assessments post-discharge, 36-item Short Form Survey, PROMIS Cognitive Function Abilities Subset 4a, and 30-day readmission rates', 'presence of delirium, defined by positive long-form Confusion Assessment Method screening', 'additional HELP- and family-based performance metrics along with various neurocognitive and clinical recovery measures']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3874055', 'cui_str': 'Paging system'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.190457,"This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery.  ","[{'ForeName': 'Phillip E', 'Initials': 'PE', 'LastName': 'Vlisides', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Jacqueline W', 'Initials': 'JW', 'LastName': 'Ragheb', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Aleda', 'Initials': 'A', 'LastName': 'Leis', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Schoettinger', 'Affiliation': 'Department of Social Work, Michigan Medicine, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hickey', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'McKinney', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Brooks', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Zierau', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Norcott', 'Affiliation': 'Department of Internal Medicine, Division of Geriatric and Palliative Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, MI, 48170, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO, 63110, USA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Min', 'Affiliation': 'Department of Internal Medicine, Division of Geriatric and Palliative Medicine, University of Michigan Medical School, Ann Arbor, MI, 48109, USA.'}]",F1000Research,['10.12688/f1000research.20597.2']
2073,32937170,"Acute exercise increases circulating IGF-1 in Alzheimer's disease patients, but not in older adults without dementia.","OBJECTIVES


Increased Insulin-like growth factor I (IGF-1) has been associated with improvement of cognitive function in response to exercise. Evidences indicate a role for IGF-1 in beta-amyloid clearance and reducing hyperphosphorylation tau in Alzheimer's disease (AD). There is a need to investigate the IGF-1 response to exercise in AD patients due to well-known potential effects of exercise on IGF-1. The aim of this study was to examine circulating IGF-1 levels in AD patients and older adults without dementia after acute exercise and to verify the associations among cardiorespiratory fitness, cognition and IGF-1 levels.
METHOD


Seventy-four older adults (40 older adults without dementia and 34 AD patients) participated in this study. The outcomes included IGF-1 plasma levels and performance in the submaximal exercise stress test. Secondary outcomes included cognitive functions, depressive symptoms, level of physical activity, insulin-resistance, and cholesterol. All participants performed the incremental test on a treadmill and IGF-1 was collected before and after the exercise.
RESULTS


A tendency to the difference of baseline IGF-1 plasma levels between the groups was found. After the acute exercise AD patients also presented higher levels of circulating IGF-1 compared to the Older adults without dementia. Correlations among cardiorespiratory fitness and cognitive functions were found.
CONCLUSION


The findings suggest that AD patients and older adults respond differently to acute exercise in terms of circulating IGF-1 levels. This response seems to indicate either an IGF-1 resistance or a compensatory exercise-induced to lower IGF-1 levels in AD patients. Cardiorespiratory fitness is associated with global cognition, executive function, attention and information processing speed.",2020,A tendency to the difference of baseline IGF-1 plasma levels between the groups was found.,"[""Alzheimer's disease patients"", 'AD patients and older adults', ""Alzheimer's disease (AD"", 'Seventy-four older adults (40 older adults without dementia and 34 AD patients', 'AD patients and older adults without dementia after acute exercise']",['Acute exercise'],"['levels of circulating IGF-1', 'cardiorespiratory fitness and cognitive functions', 'IGF-1 levels', 'IGF-1 plasma levels and performance in the submaximal exercise stress test', 'baseline IGF-1 plasma levels', 'IGF-1 response', 'circulating IGF-1', 'cognitive functions, depressive symptoms, level of physical activity, insulin-resistance, and cholesterol', 'circulating IGF-1 levels']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",74.0,0.0477822,A tendency to the difference of baseline IGF-1 plasma levels between the groups was found.,"[{'ForeName': 'Angelica Miki', 'Initials': 'AM', 'LastName': 'Stein', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; UTFPR, Federal University of Technology - Paraná (UTFPR), Campus Curitiba, Brazil. Electronic address: angelica_stein@yahoo.com.br.'}, {'ForeName': 'Thays Martins Vital', 'Initials': 'TMV', 'LastName': 'da Silva', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Instituto Federal Goiano, Campus Avançado Hidrolândia, Brazil.'}, {'ForeName': 'Flávia Gomes de Melo', 'Initials': 'FGM', 'LastName': 'Coelho', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Postgraduate Program in Physical Education, Federal University of Triangulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'André Veloso', 'Initials': 'AV', 'LastName': 'Rueda', 'Affiliation': 'Departamento de Farmacologia, Instituto de Ciências Biomédicas, Universidade de São Paulo, Campus São Paulo, Brazil.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Camarini', 'Affiliation': 'Departamento de Farmacologia, Instituto de Ciências Biomédicas, Universidade de São Paulo, Campus São Paulo, Brazil.'}, {'ForeName': 'Ruth Ferreira Santos', 'Initials': 'RFS', 'LastName': 'Galduróz', 'Affiliation': 'Instituto de Biociências, Universidade Estadual Paulista (UNESP), Campus Rio Claro, Brazil; Center of Mathematics, Computing and Cognition, University Federal of ABC (UFABC), Campus São Bernardo, Brazil.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112903']
2074,32937192,"Oxytocin effects on the cognition of women with postpartum depression: A randomized, placebo-controlled clinical trial.","BACKGROUND


One of the most common mental disorders in the perinatal period is postpartum depression (PPD), which is associated with impaired emotional functioning due to alterations in different cognitive aspects including thought and facial emotion recognition (FER). Emotional impairments may affect the interaction and care offered to infants and their later development and therefore interventions with potential to minimize impairments associated with PPD are opportune. Oxytocin (OXT) was shown to have therapeutic properties associated with the promotion of affiliative and pro-social behaviors in different mental disorders. Few studies have assessed its therapeutic potential in PPD.
OBJECTIVES


To assess the effects of the acute administration of intranasal OXT (24 IU) on FER of baby faces and negative thoughts after delivery in mothers with and without PPD.
METHODS


We conducted a randomized double-blind, placebo-controlled trial with a crossover design involving mothers with PPD (N = 20) and without PPD (N = 35) in the puerperium. Participants completed a static task of FER of baby faces and a questionnaire of post-natal negative thoughts.
RESULTS


Mothers with PPD had increased scores of negative thoughts about motherhood/infants, but no impairments in FER, when compared to healthy mothers. OXT had no effects on the rates of correct judgments or response times in the FER task, but was associated with response biases to facial happiness and the reduction of negative thoughts in mothers with PPD.
DISCUSSION/CONCLUSION


OXT may have positive effects on maternal affiliative behavior, maternal care, and mother-infant interactions as suggested by changes found in different cognitive aspects, thus minimizing the deleterious effects of PPD on child development.",2020,"RESULTS


Mothers with PPD had increased scores of negative thoughts about motherhood/infants, but no impairments in FER, when compared to healthy mothers.","['women with postpartum depression', 'mothers with and without PPD', 'mothers with PPD', 'mothers with PPD (N\u202f=\u202f20) and without PPD (N\u202f=\u202f35) in the puerperium']","['intranasal OXT', 'OXT', 'placebo', 'Oxytocin', 'Oxytocin (OXT']","['rates of correct judgments or response times', 'FER of baby faces and negative thoughts', 'scores of negative thoughts', 'static task of FER of baby faces and a questionnaire of post-natal negative thoughts']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0034042', 'cui_str': 'Puerperium'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1142075', 'cui_str': 'Negative thoughts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0454729', 'cui_str': 'Natal'}]",,0.382587,"RESULTS


Mothers with PPD had increased scores of negative thoughts about motherhood/infants, but no impairments in FER, when compared to healthy mothers.","[{'ForeName': 'Mariana Fortunata', 'Initials': 'MF', 'LastName': 'Donadon', 'Affiliation': 'Medical School of Ribeirão Preto, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Martin-Santos', 'Affiliation': 'Servicio de Psiquiatria y Psicología, Hospital Clinic, Universidad de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Flávia', 'Initials': 'F', 'LastName': 'L Osório', 'Affiliation': 'Medical School of Ribeirão Preto, São Paulo University, Ribeirão Preto, SP, Brazil; National Institute for Science and Technology (INCT-TM, CNPq), Brasília, Brazil. Electronic address: flaliosorio@gmail.com.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110098']
2075,32937232,A randomised oral fluoride retention study comparing intra-oral kinetics of fluoride-containing dentifrices before and after dietary acid exposure.,"OBJECTIVE


This exploratory, randomised, single-blind, crossover, study evaluated fluoride and calcium ion concentrations and pH following use of one of two 1450 ppm fluoride (NaF), 5% w/w KNO 3  dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse.
DESIGN


Eighteen participants used their assigned dentifrice, rinsed with DI water, then expectorate was collected. Sixty min post-brushing, participants rinsed with OJ or DI water then expectorate was collected. Saliva samples were collected pre-brushing and at 1, 5, 10, 15, 30 and 60 min post-brushing and following the 60 min OJ/DI water rinse. The pH of samples was taken.
RESULTS


Significant differences (p < 0.05) were found in salivary fluoride ion concentrations between test and comparator dentifrices at 30 and 60 min and following the 60 min OJ rinse, favouring the former. Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter. No pH differences were shown prior to OJ/water rinse. Products were generally well-tolerated.
CONCLUSIONS


Results confirmed that acid-labile fluoride is released from the oral cavity following a dietary acid challenge and showed that formulation excipients may impact on retention of such.",2020,"Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter.",[],"['fluoride-containing dentifrices', '1450 ppm fluoride (NaF), 5% w/w KNO 3  dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse']","['tolerated', 'salivary fluoride ion concentrations', 'salivary calcium ion concentration']",[],"[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C1849409', 'cui_str': 'Retinal detachment and occipital encephalocele'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0173050', 'cui_str': 'cocamidopropyl betaine'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0074764', 'cui_str': 'Pyrophosphate sodium'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}]",,0.0288269,"Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter.","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Burnett', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: Gary.R.Burnett@gsk.com.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Nehme', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: drmnehme@gmail.com.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Parkinson', 'Affiliation': ""GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Electronic address: charles.x.parkinson@gsk.com.""}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Karwal', 'Affiliation': 'GSK Consumer Healthcare, One Horizon Center, Golf Course Road, DLF Phase 5, Gurgaon, 12202, India. Electronic address: ritukarwal0283@gmail.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Badrock', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: thomas.badrock@intertek.com.'}, {'ForeName': 'Gavin Vaughan', 'Initials': 'GV', 'LastName': 'Thomas', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: gavin.thomas@intertek.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Intertek Clinical Research Services, Oaklands Office Park, Hooton Rd, Hooton, Cheshire, CH66 7NZ UK. Electronic address: peter.hall@intertek.com.'}]",Archives of oral biology,['10.1016/j.archoralbio.2020.104891']
2076,32940257,Cardiovascular system parameters in participants of Arctic expeditions,"OBJECTIVES


A method of continuous heart rate (HR) and blood pressure (BP) recording was used for the evaluation of the cardiovascular system parameters in participants of short-term (<1 month) high-latitude expeditions, in comparison with the parameters of residents of Central Russia and the Arctic region.
MATERIAL AND METHODS


A dynamic examination of participants of Arctic expeditions (30 men, residents of middle-latitude regions, aged 46.7±1.7 years), workers permanently living in Central Russia (the Moscow region, 44 men, aged 46.7±1.0 years) and residents of the North (the Murmansk region, 35 men, aged 46.6±1.3 years) was performed. The authors used a spiroartheriocardiorythmograph allowing the parallel recording of HR, BP, spectral characteristics of HR variability (HRV) and the variability of systolic BP (sBP) and diastolic BP (dBP), cardiac performance parameters, and spontaneous baroreflex sensitivity (BRS). The parameters were recorded at rest, in a sitting position, over 2 min.
RESULTS


The basic clinical parameters (HR, BP and cardiac performance) did not differ in the workers living in different climatic zones. However, the residents of the North demonstrated a lower total power (TP) of the dBP variability spectrum and a lower relative power of the high-frequency (HF) range in both the sBP and dBP variability spectra. The participants of expeditions to the North had a lower TP of the HRV spectrum (in comparison with both control groups) that did not change during the expeditions; BRS was reduced, while the TP of the sBP spectrum was increased in comparison with the corresponding parameters obtained from the residents of circumpolar regions, and decreased during the expedition in parallel with a decrease in the sBP values. The TP of both the sBP and dBP variability spectra, as well as the power of the HF range in these spectra, were similar in the participants of expeditions to those obtained from the residents of Central Russia, and they considerably surpassed the corresponding parameters in the northerners surveyed.
CONCLUSIONS


The revealed peculiarities of the cardiovascular system in the participants of high-latitude expeditions can be considered as correlates of positive, and adequate in terms of the physiological value, adaptive shifts in the autonomous regulation of the cardiovascular system.",2020,"The basic clinical parameters (HR, BP and cardiac performance) did not differ in the workers living in different climatic zones.","['participants of short-term (<1 month) high-latitude expeditions, in comparison with the parameters of residents of Central Russia and the Arctic region', 'participants of Arctic expeditions', 'participants of Arctic expeditions (30 men, residents of middle-latitude regions, aged 46.7±1.7 years), workers permanently living in Central Russia (the Moscow region, 44 men, aged 46.7±1.0 years) and residents of the North (the Murmansk region, 35 men, aged 46.6±1.3 years']",[],"['TP of the sBP spectrum', 'HR, BP, spectral characteristics of HR variability (HRV) and the variability of systolic BP (sBP) and diastolic BP (dBP), cardiac performance parameters, and spontaneous baroreflex sensitivity (BRS', 'lower TP of the HRV spectrum', 'lower total power (TP) of the dBP variability spectrum', 'sBP values', 'basic clinical parameters (HR, BP and cardiac performance', 'continuous heart rate (HR) and blood pressure (BP']","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015315', 'cui_str': 'Expeditions'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0003740', 'cui_str': 'Arctic Regions'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0026580', 'cui_str': 'Moscow'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",44.0,0.0311069,"The basic clinical parameters (HR, BP and cardiac performance) did not differ in the workers living in different climatic zones.","[{'ForeName': 'Nataliya B', 'Initials': 'NB', 'LastName': 'Pankova', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Irina B', 'Initials': 'IB', 'LastName': 'Alchinova', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Anton B', 'Initials': 'AB', 'LastName': 'Cherepov', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Elena N', 'Initials': 'EN', 'LastName': 'Yakovenko', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}, {'ForeName': 'Mikhail Y', 'Initials': 'MY', 'LastName': 'Karganov', 'Affiliation': 'Institute of General Pathology and Pathophysiology, Moscow, Russia (Laboratory of Physical, Chemical and Ecological Pathophysiology).'}]",International journal of occupational medicine and environmental health,['10.13075/ijomeh.1896.01628']
2077,32942192,Cluster randomized controlled trial (RCT) to support parental contact for children in out-of-home care.,"BACKGROUND


There is an identified need to improve the evidence-base in relation to contact visits for children in the out-of-home-care (OOHC) system, to ensure optimal outcomes.
OBJECTIVE


The aim of this cluster randomized controlled trial (RCT) was to test the effectiveness of a contact intervention for parents having supervised contact with children in long-term OOHC.
PARTICIPANTS


183 study children in 15 clusters (OOHC services) and their parent(s) were randomized to the intervention (8 clusters, 100 children) and control groups (7 clusters, 83 children) in three Australian jurisdictions.
SETTING


The manualized intervention consisted of increasing the preparation and support provided by caseworkers to parents before and after their contact visits.
METHOD


Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization. Interviews included standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent.
RESULTS


Compared with controls, the intention-to-treat (ITT) analyses showed that fewer visits were cancelled by parents in the intervention group at follow-up (-10.27; 95 % CI: -17.04 to -3.50, p = .006). In addition, per-protocol (PP) analyses showed higher caseworker receptivity to contact (6.03; 95 % CI: 0.04-12.03, p = .04), and higher parent satisfaction with contact (7.41; 95 % CI: 0.70-14.11, p = .03) in the intervention group at follow-up.
CONCLUSIONS


While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits. The findings of the current study provide an important contribution to knowledge in an area where few RCTs have been completed, notwithstanding the null findings.",2020,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","['parents having supervised contact with children in long-term OOHC', 'children in out-of-home care', 'Interviews were conducted with carers, parents and caseworkers of the study children at baseline and nine months post-randomization', '183 study children in 15 clusters (OOHC services) and their parent(s']","['kC kContact intervention', 'contact intervention']","['standardized assessment tools measuring child and adult wellbeing and relationships, carer and caseworker ability to support contact, and contact visit cancellations by the parent', 'caseworker receptivity', 'child wellbeing']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0019855', 'cui_str': 'Services, Home Care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",183.0,0.11973,"While the intervention did not have an effect on child wellbeing, as measured by the SDQ, the trial reports significant positive findings and demonstrates the benefits of the kC kContact intervention in providing support to parents to attend contact visits.","[{'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Suomi', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia; Research School of Population Health, The Australian National University, Australia.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lucas', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'McArthur', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Humphreys', 'Affiliation': 'Department of Social Work, The University of Melbourne, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Dobbins', 'Affiliation': 'School of Public Health and Community Medicine, The University of New South Wales, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Taplin', 'Affiliation': 'Institute of Child Protection Studies, The Australian Catholic University, Australia. Electronic address: stephanie.taplin@acu.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104708']
2078,32942203,Examining the effectiveness of an online program to cultivate mindfulness and self-compassion skills (Mind-OP): Randomized controlled trial on Amazon's Mechanical Turk.,"OBJECTIVES


The demand for effective psychological treatments for depression, anxiety, and heightened stress is far outstripping their supply. Accordingly, internet delivered, self-help interventions offer hope to many people, as they can be easily accessed and at a fraction of the price of face-to-face options. Mindfulness and self-compassion are particularly exciting approaches, as evidence suggests interventions that cultivate these skills are effective in reducing depression, anxiety, and heightened stress. We examined the effectiveness of a newly developed program that combines mindfulness, self-compassion, and goal-setting exercises into a brief self-guided intervention (Mind-OP). The secondary aim of this study was to investigate the feasibility of conducting a randomized-controlled trial entirely on a popular crowdsourcing platform, Amazon's Mechanical Turk (MTurk).
METHODS


We randomized 456 participants reporting heightened depression, anxiety, or stress to one of two conditions: the 4-week Mind-OP intervention (n = 227) or to an active control condition (n = 229) where participants watched nature videos superimposed onto relaxing meditation music for four consecutive weeks. We administered measures of anxiety, depression, perceived stress, dispositional and state mindfulness, self-compassion, and nonattachment.
RESULTS


Intent-to-treat and per-protocol analyses revealed that, compared to participants in the control condition, participants in the Mind-OP intervention condition reported significantly less anxiety and stress at the end of the trial, as well as significantly greater mindfulness, self-compassion, and nonattachment.
CONCLUSIONS


Mind-OP appears effective in reducing anxiety symptoms and perceived stress among MTurk participants. We highlight issues (e.g., attrition) related to feasibility of conducting randomized trials on crowdsourcing platforms such as MTurk.",2020,"CONCLUSIONS


Mind-OP appears effective in reducing anxiety symptoms and perceived stress among MTurk participants.","['MTurk participants', '456 participants reporting heightened depression, anxiety, or stress to one of two conditions: the']","[""Amazon's Mechanical Turk"", ""popular crowdsourcing platform, Amazon's Mechanical Turk (MTurk"", 'online program to cultivate mindfulness and self-compassion skills (Mind-OP', '4-week Mind-OP intervention (n\xa0=\xa0227) or to an active control condition (n\xa0=\xa0229) where participants watched nature videos superimposed onto relaxing meditation music']","['anxiety, depression, perceived stress, dispositional and state mindfulness, self-compassion, and nonattachment', 'anxiety symptoms and perceived stress', 'anxiety and stress', 'mindfulness, self-compassion, and nonattachment']","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",456.0,0.0376572,"CONCLUSIONS


Mind-OP appears effective in reducing anxiety symptoms and perceived stress among MTurk participants.","[{'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Beshai', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S0A2, Canada. Electronic address: shadi.beshai@uregina.ca.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Bueno', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S0A2, Canada.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S0A2, Canada.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Feeney', 'Affiliation': 'Department of Management and Marketing, School of Business, Rhode Island College, 600 Mount Pleasant Avenue Providence, RI 02908, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Pitariu', 'Affiliation': 'Faculty of Business Administration, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S0A2, Canada.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103724']
2079,32946257,"Rationale, Theoretical Underpinnings, and Design of HEAR-aware: Providing Adults With Hearing Loss With Tailored Support to Self-Manage Their Hearing Problems via a Smartphone App, as an Alternative to Hearing Aids.","Purpose An alarming two thirds of adults aged 50 years or over with hearing impairment who could benefit from hearing aids do not own any, leaving these adults with no support to self-manage their hearing problems. In the HEAR-aware project, it is hypothesized that self-management can be facilitated via a smartphone app if its educational content is tailored to a person's dynamic stage of readiness to take action on their hearing (stage of change) and to a person's dynamic acoustical situations (as measured via a wearable microphone) and associated challenges (as captured via ecological momentary assessment). As such, the HEAR-aware app would be an ecological momentary intervention. This research note describes the rationale and theoretical underpinnings of the app, as well as the rationale for planning a series of studies to develop and evaluate it. Study Designs After a preparatory phase, Study 1 includes qualitative group interviews to assess user needs. Next, a creative session will be held, in which all stakeholders involved will work toward a specified version of the app. Subsequently, prototypes of the app will be developed and pilot-tested (Pilot Studies 2A and 2B). Users' usage and ratings (usability and quality indicators) of the app's elements will be examined and processed in the app. Lastly, the effectiveness of the app's final version will be examined in a randomized controlled trial (Study 3). Discussion The project's merits and challenges will be discussed.",2020,Users' usage and ratings (usability and quality indicators) of the app's elements will be examined and processed in the app.,"['adults aged 50 years or over with hearing impairment who could benefit from hearing aids do not own any, leaving these adults with no support to self-manage their hearing problems']",[],"[""Users' usage and ratings (usability and quality indicators""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",[],"[{'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.0633229,Users' usage and ratings (usability and quality indicators) of the app's elements will be examined and processed in the app.,"[{'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Pronk', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Otolaryngology-Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Besser', 'Affiliation': 'Sonova AG, Stäfa, Switzerland.'}, {'ForeName': 'Cas', 'Initials': 'C', 'LastName': 'Smits', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Otolaryngology-Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Feenstra-Kikken', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Otolaryngology-Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van Beek', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Otolaryngology-Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Conny', 'Initials': 'C', 'LastName': 'Polleunis', 'Affiliation': 'Schoonenberg HoorSupport, Dordrecht, the Netherlands.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'Kramer', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Otolaryngology-Head and Neck Surgery, Ear & Hearing, Amsterdam Public Health Research Institute, the Netherlands.'}]",American journal of audiology,['10.1044/2020_AJA-19-00079']
2080,32947067,Perspectives of patients and health professionals on important factors influencing rehabilitation following acute pulmonary embolism: A multi-method study.,"BACKGROUND


International guidelines on pulmonary embolism (PE) management and rehabilitation have recently been published. However, the contained recommendation about an efficient follow-up strategy after PE is difficult for health care professionals to implement because limited research exists about what strategies are efficient.
OBJECTIVES


The study aimed to 1) describe and explore perspectives and experiences of health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions.
PATIENTS/METHODS


The study was a multi-method study, nested in a larger randomized controlled trial, combining data from two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention.
RESULTS


Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations. In terms of rehabilitation, repeatedly testing physical performance, resuming exercise under the guidance and support of specialized personnel, and access to peer support, were considered important for increasing motivation and self-efficacy for engaging in physical activity again.
CONCLUSIONS


This study offers suggestions for key elements to include in post-PE management and rehabilitation interventions, as well as the structuring of care. However, research still needs to be undertaken before solid recommendations for the content and structure of successful post-PE management and rehabilitation can be given.",2020,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","['two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention', 'acute pulmonary embolism']","['health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.070874,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","[{'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark; DEFACTUM, Corporate Quality, Central Denmark Region, Aarhus, Denmark. Electronic address: Nanna.Rolving@rm.dk.'}, {'ForeName': 'Jannie Rhod', 'Initials': 'JR', 'LastName': 'Bloch-Nielsen', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Barbara Christina', 'Initials': 'BC', 'LastName': 'Brocki', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Andreasen', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark; Public Health and Epidemiology Group, Department of Health, Science and Technology, Aalborg University, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.016']
2081,32947176,Effectiveness of a school-based road safety educational program for lower secondary school students in Denmark: A cluster-randomized controlled trial.,"Road accidents are one of the leading causes of death and injuries among adolescents and young adults. Road safety education programs aim to promote safe traffic behavior through information, skills training or fear appeals. During the last decade, an intervention type using victim testimonials has been developed. These types of programs aim to promote road safety by connecting a personal narrative of choices and consequences to the beliefs and behaviors of the audience. Studies on the effectiveness of this type of road safety programs among youngsters who are not yet drivers are still limited. This study used a cluster-randomized and controlled trial design to examine the effect of a Danish school-based road safety educational program using testimonials for students in lower secondary schools in Denmark on a) knowledge of risks factors in traffic and b) two types of behavior specifically relevant for the pre-driver target group: seatbelt use and safe bicycle behavior. Our analysis sample comprised 1007 students from 57 schools with a matched baseline and four-month follow-up response. Linear regression analyses suggest a small positive effect on the students' knowledge of the three most important risk factors in traffic but not on the age group most at risk. Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use. Neither was the effectiveness modified by gender, parental educational background, or risky cycling behavior at baseline. Although classroom-based interventions using testimonials may have the potential to increase knowledge of risk factors in traffic among adolescents, translating knowledge into safe traffic behavior is challenging. More studies are needed on how to further adapt the intervention to an age group who are not yet drivers. Such research may focus on mechanisms of change including the age-specific relevance of the ambassador's testimonial and on employing strong elements of action guidance.",2020,"Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use.","['students in lower secondary schools in Denmark on a', 'lower secondary school students in Denmark', '1007 students from 57 schools with a matched baseline and four-month follow-up response', 'youngsters who are not yet drivers', 'adolescents and young adults']","['school-based road safety educational program', 'Danish school-based road safety educational program']","['effectiveness modified by gender, parental educational background, or risky cycling behavior']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",1007.0,0.0370321,"Concerning seatbelt use or overall cycling behavior no effect was found, although a small positive effect was found on helmet use.","[{'ForeName': 'Anders Bo', 'Initials': 'AB', 'LastName': 'Bojesen', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, København K., Denmark.'}, {'ForeName': 'Signe Boe', 'Initials': 'SB', 'LastName': 'Rayce', 'Affiliation': 'VIVE - The Danish Center for Social Science Research, Herluf Trolles Gade 11, 1052, København K., Denmark. Electronic address: sbo@vive.dk.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105773']
2082,32949542,"Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial.","BACKGROUND


Many patients who require migraine preventive treatment have not been able to tolerate or have not responded to multiple previous preventive medications. We aimed to assess the safety and efficacy of galcanezumab, an antibody to calcitonin gene-related peptide, in patients with migraine who had not benefited from preventive medications from two to four categories.
METHODS


CONQUER was a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial done at 64 sites (hospitals, clinics, or research centres) in 12 countries (Belgium, Canada, Czech Republic, France, Germany, Hungary, Japan, the Netherlands, South Korea, Spain, the UK, and the USA). Patients were 18-75 years of age, with episodic or chronic migraine, with migraine onset before the age of 50 years, who had a documented failure of preventive medications from two to four drug categories in the past 10 years owing to lack of efficacy or tolerability, or both. Patients were randomised 1:1 to receive subcutaneous placebo or galcanezumab 120 mg per month (with a 240 mg loading dose administered as two 120 mg injections) for 3 months. For masking purposes, patients receiving placebo also received two injections during the first dosing visit. Randomisation was done by a computer-generated random sequence by means of an interactive web-response system stratified by country and migraine frequency (low frequency episodic migraine, four to fewer than eight migraine headache days per month; high frequency episodic migraine, eight to 14 migraine headache days per month and fewer than 15 headache days per month; chronic migraine, at least eight migraine headache days per month and at least 15 headache days per month). The primary endpoint was the overall mean change from baseline in number of monthly migraine headache days during the 3-month treatment period in all patients who were randomly assigned and received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT03559257, and is now completed.
FINDINGS


Between Sept 10, 2018, and March 21, 2019, 462 participants with episodic (269 [58%]) or chronic (193 [42%]) migraine were randomly assigned and received at least one injection with placebo (n=230) or galcanezumab (n=232). Galcanezumab-treated patients had significantly greater reduction in migraine headache days versus placebo across months 1-3. The galcanezumab group had on average 4·1 fewer monthly migraine headache days compared with baseline (13·4), while the placebo group had on average 1·0 fewer than at baseline (13·0; between-group difference -3·1 [95% CI -3·9 to -2·3]; p<0·0001; effect size=0·72). Types and number of treatment-emergent adverse events were similar between galcanezumab and placebo. Treatment-emergent adverse events were reported in 122 (53%) of 230 patients in the placebo group and 119 (51%) of 232 patients in the galcanezumab group. There were four serious adverse events during the study, two (1%) reported in the placebo group and two (1%) reported in the galcanezumab group.
INTERPRETATION


Galcanezumab was superior to placebo in the preventive treatment of migraine and was safe and well tolerated in patients for whom multiple previous standard-of-care preventive treatments had failed. Galcanezumab might represent an important treatment option for patients who have not benefited from or tolerated previous standard-of-care treatments.
FUNDING


Eli Lilly.",2020,Galcanezumab-treated patients had significantly greater reduction in migraine headache days versus placebo across months 1-3.,"['patients with migraine who had not benefited from preventive medications from two to four categories', 'Between Sept 10, 2018, and March 21, 2019, 462 participants with episodic (269 [58%]) or chronic (193 [42%]) migraine', '64 sites (hospitals, clinics, or research centres) in 12 countries (Belgium, Canada, Czech Republic, France, Germany, Hungary, Japan, the Netherlands, South Korea, Spain, the UK, and the USA', 'Patients were 18-75 years of age, with episodic or chronic migraine, with migraine onset before the age of 50 years, who had a documented failure of preventive medications from two to four drug categories in the past 10 years owing to lack of efficacy or tolerability, or both', 'patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER', 'patients who have not benefited from or tolerated previous standard-of-care treatments']","['galcanezumab and placebo', 'galcanezumab', 'Galcanezumab', 'placebo', 'subcutaneous placebo or galcanezumab']","['overall mean change from baseline in number of monthly migraine headache days', 'Safety and efficacy', 'safety and efficacy', 'migraine headache days', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",462.0,0.540374,Galcanezumab-treated patients had significantly greater reduction in migraine headache days versus placebo across months 1-3.,"[{'ForeName': 'Wim M', 'Initials': 'WM', 'LastName': 'Mulleners', 'Affiliation': 'Neurology Department, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands.'}, {'ForeName': 'Byung-Kun', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Neurology Department, Nowon Eulji Medical Center, Seoul, South Korea.'}, {'ForeName': 'Miguel J A', 'Initials': 'MJA', 'LastName': 'Láinez', 'Affiliation': 'Hospital Clínico Universitario, Universidad Católica de Valencia, Valencia, Spain.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lanteri-Minet', 'Affiliation': 'Pain Department CHU Nice and FHU InovPain Côte Azur University, Nice, France; INSERM/UdA, U1107, Neuro-Dol, Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pozo-Rosich', 'Affiliation': ""Headache Unit, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain; Headache Research Group, Vall d'Hebron Institute of Research, Department de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Tockhorn-Heidenreich', 'Affiliation': 'Eli Lilly, Windlesham, Surrey, UK.'}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'Impel NeuroPharma, Seattle, WA, USA.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Nichols', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Yunes-Medina', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA.'}, {'ForeName': 'Holland C', 'Initials': 'HC', 'LastName': 'Detke', 'Affiliation': 'Eli Lilly, Indianapolis, IN, USA. Electronic address: detke_holland_c@lilly.com.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30279-9']
2083,32953368,Implementation strategy of a CNN model affects the performance of CT assessment of EGFR mutation status in lung cancer patients.,"Objective


To compare CNN models implemented using different strategies in the CT assessment of EGFR mutation status in patients with lung adenocarcinoma.
Methods


1,010 consecutive lung adenocarcinoma patients with known EGFR mutation status were randomly divided into a training set (n=810) and a testing set (n=200). CNN models were constructed based on ResNet-101 architecture but implemented using different strategies: dimension filters (2D/3D), input sizes (small/middle/large and their fusion), slicing methods (transverse plane only and arbitrary multi-view planes), and training approaches (from scratch and fine-tuning a pre-trained CNN). The performance of the CNN models was compared using AUC.
Results


The fusion approach yielded consistently better performance than other input sizes, although the effect often did not reach statistical significance. Multi-view slicing was significantly superior to the transverse method when fine-tuning a pre-trained 2D CNN but not a CNN trained from scratch. The 3D CNN was significantly better than the 2D transverse plane method but only marginally better than the multi-view slicing method when trained from scratch. The highest performance (AUC=0.838) was achieved for the fine-tuned 2D CNN model when built using the fusion input size and multi-view slicing method.
Conclusion


The assessment of EGFR mutation status in patients is more accurate when CNN models use more spatial information and are fine-tuned by transfer learning. Our finding about implementation strategy of a CNN model could be a guidance to other medical 3D images applications. Compared with other published studies which used medical images to identify EGFR mutation status, our CNN model achieved the best performance in a biggest patient cohort.",2019,The 3D CNN was significantly better than the 2D transverse plane method but only marginally better than the multi-view slicing method when trained from scratch.,"['patients with lung adenocarcinoma', '1,010 consecutive lung adenocarcinoma patients with known EGFR mutation status', 'lung cancer patients']",[],['performance of CT assessment of EGFR mutation status'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]",[],"[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",1010.0,0.0226685,The 3D CNN was significantly better than the 2D transverse plane method but only marginally better than the multi-view slicing method when trained from scratch.,"[{'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Xiong', 'Affiliation': 'School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, 200240 China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030 China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Columbia University Medical Center, NY 10032 USA.'}, {'ForeName': 'Schwartz H', 'Initials': 'SH', 'LastName': 'Lawrence', 'Affiliation': 'Department of Radiology, Columbia University Medical Center, NY 10032 USA.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030 China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, 200240 China.'}, {'ForeName': 'Binsheng', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology, Columbia University Medical Center, NY 10032 USA.'}]","IEEE access : practical innovations, open solutions",['10.1109/access.2019.2916557']
2084,32953508,Hazard ratio of progression-free survival is an excellent predictor of overall survival in phase III randomized controlled trials evaluating the first-line chemotherapy for extensive-disease small-cell lung cancer.,"Background


Whether hazard ratio (HR) of progression-free survival (HRpfs), odds ratio (OR) of response rate (ORrr), OR of disease control rate (ORdcr), and OR of 1-year overall survival (ORos1y) used for extensive-disease small-cell lung cancer (ED-SCLC) correlate with HR of overall survival (HRos) at a randomized-trial level, especially for a trial that evaluates molecular-targeted therapy (MTT) or immune-checkpoint inhibitor (ICI), is unclear.
Methods


We included an individually randomized controlled trial (RCT) comparing two regimens as the first-line treatment for chemo-naive ED-SCLC, which have been reported in English-language since 2000. A weighted Spearman's rank correlation coefficient (r) was evaluated.
Results


We finally found 42 eligible articles consisted of 11,478 cases. Estimated r with HRos were as followings: HRpfs (29 trial, 8,573 cases, r=0.87), ORrr (39 trials, 11,030 cases, r=0.47), ORdcr (29 trials, 7,799 cases, r=0.48), and ORos1y (40 trials, 11,250 cases, r=0.69). Phase III subgroup (16 trials, 7,079 cases) yielded an excellent r between HRpfs and HRos of 0.96. ORdcr presented the best correlation with HRos for phase II trial subgroup (r=-0.64); however, this result was mainly calculated from MTT trials. HRpfs may overestimate the efficacy of MMT in a phase II trial. ORrr and ORdcr might undervalue the efficacy of ICI even in a phase III trial.
Conclusions


HRpfs can be a good surrogate of HRos, especially in a phase III trial. Depending on a single outcome in a randomized phase II trial may result in unneeded phase III trial or inappropriate abandonment of the regimen.",2020,"ORdcr presented the best correlation with HRos for phase II trial subgroup (r=-0.64); however, this result was mainly calculated from MTT trials.","['42 eligible articles consisted of 11,478 cases']","['MMT', 'molecular-targeted therapy (MTT) or immune-checkpoint inhibitor (ICI']","['ORos1y', 'hazard ratio (HR) of progression-free survival (HRpfs), odds ratio (OR) of response rate (ORrr), OR of disease control rate (ORdcr), and OR of 1-year overall survival (ORos1y) used for extensive-disease small-cell lung cancer (ED-SCLC) correlate with HR of overall survival (HRos']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0046370', 'cui_str': '2-methylcyclopentadienyl manganese tricarbonyl'}, {'cui': 'C2699893', 'cui_str': 'Targeted Molecular Therapy'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}]",8573.0,0.142523,"ORdcr presented the best correlation with HRos for phase II trial subgroup (r=-0.64); however, this result was mainly calculated from MTT trials.","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Horita', 'Affiliation': 'Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Respiratory Center, Matsusaka Municipal Hospital, Matsusaka, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hara', 'Affiliation': 'Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Department of Pulmonology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}]",Translational lung cancer research,['10.21037/tlcr-20-377']
2085,32953573,Crosslinked hyaluronic acid with liposomes and crocin for management symptoms of dry eye disease caused by moderate meibomian gland dysfunction.,"AIM


To study the effect of uncrosslinked and crosslinked hyaluronic acid combined with other artificial tear components in patients with dry eye caused by moderate meibomian gland dysfunction.
METHODS


Prospective, single-blind, contralateral eye study. Fifty eyes (25 patients) were analyzed. Eye selection for each tear type was random, and the eye drop formulations, 0.4% uncrosslinked hyaluronic acid and 0.2% galactoxyloglucan (tear A) and 0.15% crosslinked hyaluronic acid, crocin, and liposomes (tear B) were used. The determined dosing schedule was three times a day for six weeks, and the study participants underwent a clinical examination before and 45d after lubricant treatment. The Schirmer test, tear breakup time (TBUT) test, and Ocular Surface Disease Index (OSDI) questionnaire were applied before and after instillation period with both types of artificial tears.
RESULTS


On the Schirmer test, a significant improvement was obtained with both tear A ( P <0.01) and tear B ( P <0.01). On the TBUT test, a significant improvement was obtained with tear A ( P <0.01) and tear B ( P <0.01). The OSDI score significantly decreased after instillation period with both artificial tear types ( P <0.01).
CONCLUSION


Uncrosslinked hyaluronic acid combined with other components, such as tamarind seed polysaccharide, and crosslinked hyaluronic acid combined with liposomes and crocin are effective for management symptoms of dry eye disease.",2020,"The OSDI score significantly decreased after instillation period with both artificial tear types ( P <0.01).
","['Fifty eyes (25 patients) were analyzed', 'patients with dry eye caused by moderate meibomian gland dysfunction']","['Uncrosslinked hyaluronic acid combined with other components, such as tamarind seed polysaccharide, and crosslinked hyaluronic acid combined with liposomes and crocin', 'Crosslinked hyaluronic acid with liposomes and crocin', 'uncrosslinked and crosslinked hyaluronic acid combined with other artificial tear components', 'uncrosslinked hyaluronic acid and 0.2% galactoxyloglucan (tear A) and 0.15% crosslinked hyaluronic acid, crocin, and liposomes (tear B']","['OSDI score', 'Schirmer test, tear breakup time (TBUT) test, and Ocular Surface Disease Index (OSDI) questionnaire']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0440297', 'cui_str': 'Tamarind seed'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0056503', 'cui_str': 'crocin'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0039409', 'cui_str': 'Tears'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",50.0,0.0160266,"The OSDI score significantly decreased after instillation period with both artificial tear types ( P <0.01).
","[{'ForeName': 'José-María', 'Initials': 'JM', 'LastName': 'Sánchez-González', 'Affiliation': 'Department of Physics of Condensed Matter, Optics Area, University of Seville, Seville 41012, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'De-Hita-Cantalejo', 'Affiliation': 'Department of Physics of Condensed Matter, Optics Area, University of Seville, Seville 41012, Spain.'}, {'ForeName': 'María Carmen', 'Initials': 'MC', 'LastName': 'Sánchez-González', 'Affiliation': 'Department of Physics of Condensed Matter, Optics Area, University of Seville, Seville 41012, Spain.'}]",International journal of ophthalmology,['10.18240/ijo.2020.09.05']
2086,32953642,Efficacy of the Probiotic Probiotical Confirmed in Acute Gastroenteritis.,"Purpose


Some probiotic strains reduce the duration of acute diarrhea. Because of strain and product specificity, each product needs to be supported by clinical data. This study aimed to test the efficacy of the synbiotic food supplement Probiotical ( Streptococcus thermophilus ,  Lactobacillus rhamnosus ,  Lactobacillus acidophilus ,  Bifidobacterium lactis ,  Bifidobacterium infantis , fructo-oligosaccharides) in children with acute gastroenteritis of likely infectious origin. The primary endpoint was the number of children with normal stool consistency during the treatment duration.
Methods


A total of 46 children (aged 3.6 months to 12 years) with acute gastroenteritis that started less than 48 hours prior to their visit at a hospital-based emergency department were included in this prospective, randomized, placebo-controlled trial. All children were treated with oral rehydration solution and placebo (n=20) or the test product (n=26).
Results


Significantly more children had a normal stool consistency on days 1 and 2 in the probiotic group: 5 children (20%) on day 1 in the probiotic group compared with none in the placebo group ( p =0.046). On day 2, 11 children in the probiotic group (46%) and 3 (16%) in the placebo group ( p =0.024) had a normal stool consistency. The mean duration of diarrhea was shorter in the probiotic group compared with that in the placebo group (3.04±1.36 vs. 4.20±1.34 days) ( p =0.018).
Conclusion


The test product was shown to normalize stool consistency significantly more rapidly than the placebo. These data confirm the findings from a previous study in a larger group of children performed in a primary healthcare setting.",2020,"The mean duration of diarrhea was shorter in the probiotic group compared with that in the placebo group (3.04±1.36 vs. 4.20±1.34 days) ( p =0.018).
","['Acute Gastroenteritis', 'children with acute gastroenteritis of likely infectious origin', '46 children (aged 3.6 months to 12 years) with acute gastroenteritis that started less than 48 hours prior to their visit at a hospital-based emergency department']","['oral rehydration solution and placebo', 'synbiotic food supplement Probiotical ( Streptococcus thermophilus ,  Lactobacillus rhamnosus ,  Lactobacillus acidophilus ,  Bifidobacterium lactis ,  Bifidobacterium infantis , fructo-oligosaccharides', 'placebo']","['number of children with normal stool consistency', 'normalize stool consistency', 'duration of acute diarrhea', 'mean duration of diarrhea', 'normal stool consistency']","[{'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0078516', 'cui_str': 'World Health Organization oral rehydration solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0318180', 'cui_str': 'Streptococcus salivarius subsp. thermophilus'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0314976', 'cui_str': 'Bifidobacterium Infantis'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0474509', 'cui_str': 'Feces normal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",46.0,0.271032,"The mean duration of diarrhea was shorter in the probiotic group compared with that in the placebo group (3.04±1.36 vs. 4.20±1.34 days) ( p =0.018).
","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kluijfhout', 'Affiliation': 'KidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Thanh-Van', 'Initials': 'TV', 'LastName': 'Trieu', 'Affiliation': 'CHL KannerKlinik, Urgences Pédiatriques, Luxembourg, Luxembourg.'}, {'ForeName': 'Yvan', 'Initials': 'Y', 'LastName': 'Vandenplas', 'Affiliation': 'KidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.'}]","Pediatric gastroenterology, hepatology & nutrition",['10.5223/pghn.2020.23.5.464']
2087,32954068,Effect of Sevelamer on Calciprotein Particles in Hemodialysis Patients: The Sevelamer Versus Calcium to Reduce Fetuin-A-Containing Calciprotein Particles in Dialysis (SCaRF) Randomized Controlled Trial.,"Introduction


Calciprotein particles (CPPs) are potentially modifiable mediators of phosphate toxicity in patients with kidney disease. We compared the effects of calcium carbonate (CC) and the non-calcium-based phosphate binder sevelamer on CPP levels in patients undergoing hemodialysis (HD). We hypothesized that treatment with sevelamer would achieve greater reductions in amorphous calcium phosphate-containing CPP (CPP-1) and hydroxyapatite-containing CPP (CPP-2) owing to reduced calcium loading and anti-inflammatory pleiotropic effects.
Methods


We conducted an open-label, randomized controlled trial (RCT) in which 31 stable prevalent HD patients were allocated to receive either sevelamer hydrochloride (SH), sevelamer carbonate (SC), or CC for 24 weeks. Dual primary endpoints were the between groups differences in serum CPP-1 and CPP-2 levels at 24 weeks in SH + SC-treated versus CC-treated patients. Effects on aortic pulse wave velocity (aPWV), inflammatory cytokines (interleukin-6 and -8), and effects across individual treatment arms were also assessed.
Results


Serum CPP-1, but not CPP-2, levels were lower in those randomly assigned to the sevelamer (SH + SC) group compared with the CC group at 24 weeks (-70%, 95% confidence interval [CI] -90% to -15%,  P  = 0.02). In subgroup analysis, this effect was confined to those receiving SC (-83.4%, 95% CI -95.7% to -36.8%,  P  = 0.01). aPWV and interleukin-8 levels were also lower in those who received sevelamer compared with CC at 24 weeks (-2.0 m/s, 95% CI -2.9 to -1.1; -57%, 95% CI -73% to -30%, respectively, both  P  = 0.01). Conventional markers of mineral metabolism remained stable across all treatment groups.
Discussion


Compared with treatment with CC, use of sevelamer for 24 weeks was associated with lower serum CPP-1 levels and a reduction in aPWV and systemic inflammation.",2020,aPWV and interleukin-8 levels were also lower in those who received sevelamer compared with CC at 24 weeks (,"['31 stable prevalent HD patients', 'Hemodialysis Patients', 'patients undergoing hemodialysis (HD', 'patients with kidney disease']","['Sevelamer Versus Calcium', 'calcium carbonate (CC) and the non-calcium-based phosphate binder sevelamer', 'Introduction\n\n\nCalciprotein particles (CPPs', 'sevelamer (SH\xa0+ SC', 'Sevelamer', 'sevelamer hydrochloride (SH), sevelamer carbonate (SC', 'sevelamer']","['CPP levels', 'Serum CPP-1', 'serum CPP-1 and CPP-2 levels', 'aPWV and systemic inflammation', 'aortic pulse wave velocity (aPWV), inflammatory cytokines (interleukin-6 and -8), and effects', 'aPWV and interleukin-8 levels', 'serum CPP-1 levels', 'mineral metabolism']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]","[{'cui': 'C0718050', 'cui_str': 'sevelamer'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0772463', 'cui_str': 'Sevelamer hydrochloride'}, {'cui': 'C1721288', 'cui_str': 'Sevelamer carbonate'}]","[{'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.097942,aPWV and interleukin-8 levels were also lower in those who received sevelamer compared with CC at 24 weeks (,"[{'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Smith', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Fei Fei M', 'Initials': 'FFM', 'LastName': 'Pan', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Tim D', 'Initials': 'TD', 'LastName': 'Hewitson', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Nigel D', 'Initials': 'ND', 'LastName': 'Toussaint', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Holt', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}]",Kidney international reports,['10.1016/j.ekir.2020.06.014']
2088,32954070,Estimation of Changes in Kidney Volume Growth Rate in ADPKD.,"Introduction


In the Mayo Imaging Classification (MIC) for autosomal dominant polycystic kidney disease (ADPKD), the height-adjusted total kidney volume (HtTKV) growth rate is estimated for classification. Estimated HtTKV slope, termed as eHTKV-α, is calculated by the equation [HtTKV at age t] = K(1+α/100) (t-A) , where K = 150 and A = 0 are used in MIC. If eHTKV-α is nearly stable during a standard-of-care period, the change in eHTKV-α from baseline can be used for estimation of the treatment effect on the HtTKV slope.
Methods


The constancy of eHTKV-α (A = 0 and K = 150) was evaluated using 453 placebo-assigned subjects in the Tolvaptan Efficacy and Safety in Management of ADPKD and Its Outcomes (TEMPO) 3:4 trial. A and K were sought out respectively by a converged pattern of regression lines of log10(HtTKV) plotted against age for subgroups divided according to MIC, and by change in eHTKV-α from baseline. A total of 239 standard-of-care patients from the Kyorin University Cohort (KUC) served as validation. Changes in eHTKV-α from baseline were evaluated in 809 tolvaptan-treated subjects in TEMPO 3:4.
Results


In placebo-assigned subjects, eHTKV-α (A = 0 and K = 150) changed significantly from baseline at the third year. As regression lines of placebo-assigned subgroups converged around age 0, A was set as 0, which was confirmed by KUC. K = 130 was selected because of minimal change in eHTKV-α from baseline. The KUC validated the constancy of eHTKV-α (A = 0 and K = 130) but not that of eHTKV-α (A=0 and K=150). In tolvaptan-treated subjects, eHTKV-α remained significantly lower than baseline for 3 years.
Conclusions


eHTKV-α (A = 0 and K = 130) was nearly stable from baseline through follow-up in standard-of-care adults. Treatment effects on the HtTKV slope can be estimated by changes in eHTKV-α from baseline.",2020,"In placebo-assigned subjects, eHTKV-α (A = 0 and K = 150) changed significantly from baseline at the third year.","['809 tolvaptan-treated subjects in TEMPO 3:4', '239 standard-of-care patients from the Kyorin University Cohort (KUC) served as validation']","['placebo', 'eHTKV-α']",[],"[{'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0124791', 'cui_str': 'Kyorin'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],809.0,0.0778939,"In placebo-assigned subjects, eHTKV-α (A = 0 and K = 150) changed significantly from baseline at the third year.","[{'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Higashihara', 'Affiliation': 'Department of Hereditary Kidney Disease Research, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Urology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ouyang', 'Affiliation': 'Otsuka Pharmaceutical Development and Commercialization, Rockville, Maryland, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Otsuka Pharmaceutical Development and Commercialization, Rockville, Maryland, USA.'}, {'ForeName': 'Kikuo', 'Initials': 'K', 'LastName': 'Nutahara', 'Affiliation': 'Department of Urology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Mistuhiro', 'Initials': 'M', 'LastName': 'Tanbo', 'Affiliation': 'Department of Urology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Urology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Taguchi', 'Affiliation': 'Department of Urology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Muto', 'Affiliation': 'Department of Urology, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kaname', 'Affiliation': 'Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Radiology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Horie', 'Affiliation': 'Department of Urology, Juntendo University School of Medicine, Tokyo, Japan.'}]",Kidney international reports,['10.1016/j.ekir.2020.06.011']
2089,32954073,Bioimpedance Analysis-Guided Volume Expansion for the Prevention of Contrast-Induced Acute Kidney Injury (the BELIEVE Pilot Randomized Controlled Trial).,"Introduction


Peri-procedural i.v. fluid administration is important for the prevention of contrast-induced acute kidney injury (CI-AKI). However, standardized fluid management protocols may not be suitable for all patients. We therefore wished to determine whether an individualized fluid administration protocol guided by measuring extracellular water (ECW) using bioimpedance analysis (BIA) would be safe and would reduce the incidence CI-AKI compared to a standardized fluid administration prescription.
Methods


In this pilot, randomized, parallel-group, single-blind, controlled trial, we compared the effect of BIA-guided isotonic bicarbonate administration according to the ratio of ECW to total body water (ECW/TBW) to our standard isotonic bicarbonate protocol in regard to the safety and efficacy of preventing CI-AKI in chronic kidney disease patients undergoing elective cardiac angiography. Our primary outcome was the incidence of CI-AKI, which was defined as a ≥0.3 mg/dl or 150% increase in serum creatinine concentration within 48 to 72 hours after cardiac angiography .
Results


We studied 61 patients, 30 in the bioimpedance group and 31 in the control group. Age was similar (72.5 ± 7 vs. 71.4 ± 7.9 years), as were body mass index (25.5 vs. 25.8 kg/m 2 ) and baseline serum creatinine (1.3 ± 0.3 vs. 1.4 ± 0.4 mg/dl). The peri-procedural fluid volume administered was significantly greater in the BIA-guided hydration group (899.0 ± 252.7 ml vs. 594.4 ± 125.9 ml,  P  < .01). The incidence of CI-AKI was 3.3% in BIA-guided hydration group and 6.5% in the control group (relative risk = 0.52, 95% confidence interval = 0.05-5.40,  P  = 1.00). Adverse events reported were comparable between groups (6.7% vs. 6.5%,  P  = 1.00).
Conclusions


The overall incidence of CI-AKI after cardiac angiography in our patients with mild-to-moderate renal insufficiency was lower than anticipated. Isotonic bicarbonate administration guided by bioimpedance measurements was safe, and probably led to a lower incidence of CI-AKI, although this not reach statistical significance.",2020,"Adverse events reported were comparable between groups (6.7% vs. 6.5%,  P  = 1.00).
","['chronic kidney disease patients undergoing elective cardiac angiography', 'Age was similar (72.5 ± 7 vs. 71.4 ± 7.9 years), as were body mass index (25.5 vs. 25.8 kg/m 2 ) and baseline serum creatinine (1.3 ± 0.3 vs. 1.4 ± 0.4 mg/dl', 'Contrast-Induced Acute Kidney Injury', '61 patients, 30 in the bioimpedance group and 31 in the control group']","['Isotonic bicarbonate', 'Bioimpedance Analysis-Guided Volume Expansion', 'isotonic bicarbonate protocol', 'BIA-guided isotonic bicarbonate']","['Adverse events', 'overall incidence of CI-AKI', 'safety and efficacy', 'incidence of CI-AKI', 'serum creatinine concentration']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002971', 'cui_str': 'Angiocardiography'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",61.0,0.281561,"Adverse events reported were comparable between groups (6.7% vs. 6.5%,  P  = 1.00).
","[{'ForeName': 'Sarassawan', 'Initials': 'S', 'LastName': 'Kananuraks', 'Affiliation': 'Department of Medicine, Division of Nephrology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Montira', 'Initials': 'M', 'LastName': 'Assanatham', 'Affiliation': 'Department of Medicine, Division of Nephrology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sarinya', 'Initials': 'S', 'LastName': 'Boongird', 'Affiliation': 'Department of Medicine, Division of Nephrology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chagriya', 'Initials': 'C', 'LastName': 'Kitiyakara', 'Affiliation': 'Department of Medicine, Division of Nephrology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kanin', 'Initials': 'K', 'LastName': 'Thammavaranucupt', 'Affiliation': 'Renal Unit, Department of Medicine, Faculty of Medicine, Chakri Naruebodindra Medical Institute, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thosaphol', 'Initials': 'T', 'LastName': 'Limpijarnkij', 'Affiliation': 'Department of Medicine, Division of Cardiology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Daruneewan', 'Initials': 'D', 'LastName': 'Warodomwichit', 'Affiliation': 'Department of Medicine, Division of Nutrition and Biochemical Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davenport', 'Affiliation': 'University College London Centre for Nephrology, Royal Free Hospital, University College London, London, UK.'}, {'ForeName': 'Arkom', 'Initials': 'A', 'LastName': 'Nongnuch', 'Affiliation': 'Department of Medicine, Division of Nephrology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Kidney international reports,['10.1016/j.ekir.2020.07.009']
2090,32954233,"Caesarean delivery rates and analgesia effectiveness following injections of sterile water for back pain in labour: A multicentre, randomised placebo controlled trial.","Background


About a third of women experience severe back pain during labour. Injecting small volumes of intracutaneous sterile water into the lumbar region can be used to relieve this pain, however the procedure is controversial and previous reviews call for high quality trials to establish efficacy. We evaluated the impact on birth outcomes and analgesic effects of sterile water injections.
Methods


A multicentre, double-blind trial undertaken between December 2012 and December 2017 in one British and 15 Australian maternity units. Women experiencing severe back-pain in labour were assigned (1:1) by an independently generated randomisation schedule stratified by site to injections of either sterile water or saline placebo. Participants and caregivers were blinded to group allocation. The primary outcome was caesarean delivery rate. Main secondary outcomes included at least 30% or 50% reduction in self-reported pain scores at 30, 60 and 90 minutes after treatment. Intention to treat analysis were used and the level of significance for the multiple clinical outcomes was set at  p <0.001 with the Bonferroni correction applied. The study is registered with the ACTRN Registry number, ACTRN1261100022195.
Findings


Between December 9, 2012, and December 15, 2017, 1166 women were recruited and randomised: 587 women received sterile water injections (SWI) and 579 a saline placebo. Seven women in the SWI group and 12 in the placebo group were excluded as consent was not completed, leaving 580 and 567, respectively, included in the analysis. The proportions of caesarean delivery were 17·1% (82 of 580) in the SWI group and 14·8% (82 of 567) in the placebo (RR 1·16, 95% CI 0·88-1.51;  p  = 0·293). At 30 min post treatment 60·8% (330 of 543) of women in the SWI group reported a 30% reduction in self-reported pain compared to 31·4% (163 of 520) placebo (RR 1·94, 95% CI 1·68-2·24;  p =<0·001) and 43·3% (235 of 534) SWI reported a 50% reduction versus 18·1% (94 of 520) placebo (RR 2·39, 95% CI 1·95-2·94;  p =<0·001). The analgesic effect of SWI compared to placebo remained significant at 60 and 90 min post-treatment. There were no significant differences in other maternal or neonatal outcomes.
Interpretation


Compared to placebo, injections of sterile water did not reduce rates of caesarean delivery. For the main secondary outcome of pain relief the intervention did result in significantly more women reporting at least 30% and 50% reduction in pain for up to 90 min. Water injections have no effect on birth outcomes though can be an effective treatment for the relief of labour-related back pain.Funded by the National Health and Medical Research Council.",2020,Water injections have no effect on birth outcomes though can be an effective treatment for the relief of labour-related back pain.,"['Women experiencing severe back-pain in labour', 'Seven women in the SWI group and 12 in the', 'labour', 'women experience severe back pain during labour', 'December 2012 and December 2017 in one British and 15 Australian maternity units', 'Findings\n\n\nBetween December 9, 2012, and December 15, 2017, 1166 women were recruited and randomised: 587 women received']","['sterile water injections (SWI) and 579 a saline placebo', 'sterile water injections', 'placebo', 'sterile water', 'sterile water or saline placebo']","['analgesic effect of SWI', 'self-reported pain scores', 'rates of caesarean delivery', 'pain relief', 'caesarean delivery rate', 'self-reported pain', 'maternal or neonatal outcomes', 'proportions of caesarean delivery', 'Caesarean delivery rates and analgesia effectiveness', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1163679', 'cui_str': 'Water 1 g/mL solution for injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]","[{'cui': 'C1163679', 'cui_str': 'Water 1 g/mL solution for injection'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1163679', 'cui_str': 'Water 1 g/mL solution for injection'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1166.0,0.724972,Water injections have no effect on birth outcomes though can be an effective treatment for the relief of labour-related back pain.,"[{'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, Midwifery and Social Work, University Of Queensland, St Lucia, Queensland, Australia.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Molly Wardaguga Research Centre, Charles Darwin University, Brisbane, Australia.'}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Collins', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, United Kingdom.""}, {'ForeName': 'Lena B', 'Initials': 'LB', 'LastName': 'Mårtensson', 'Affiliation': 'School of Health Sciences University of Skövde, Sweden.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Randall', 'Affiliation': 'Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Toni-Marie', 'Initials': 'TM', 'LastName': 'Rowe', 'Affiliation': ""Women's and Children's Health Network, Adelaide, South Australia.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Kildea', 'Affiliation': 'Molly Wardaguga Research Centre, Charles Darwin University, Brisbane, Australia.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100447']
2091,32954349,Working memory training increases neural efficiency in Parkinson's disease: a randomized controlled trial.,"Impairment of working memory and executive functions is already frequently observed in early stages of Parkinson's disease. Improvements in working memory performance in this cohort could potentially be achieved via working memory training. However, the specific neural mechanisms underlying different working memory processes such as maintenance as opposed to manipulation are largely under-investigated in Parkinson's disease. Moreover, the plasticity of these correlates as a function of working memory training is currently unknown in this population. Thus, the working memory subprocesses of maintenance and manipulation were assessed in 41 cognitively healthy patients with Parkinson's disease using a newly developed working memory paradigm and functional MRI. Nineteen patients were randomized to a 5-week home-based digital working memory training intervention while the remaining patients entered a control, wait list condition. Working memory task-related activation patterns and context-dependent functional connectivity, as well as the change of these neural correlates as a function of training, were assessed. While both working memory processes activated an extended frontoparietal-cerebellar network, only the manipulation of items within working memory also recruited the anterior striatum. The intervention effect on the neural correlates was small, but decreased activation in areas relevant for working memory could be observed, with activation changes correlating with behavioural change. Moreover, training seemed to result in decreased functional connectivity when pure maintenance was required, and in a reorganization of functional connectivity when items had to be manipulated. In accordance with the neural efficacy hypothesis, training resulted in overall reduced activation and reorganized functional connectivity, with a differential effect on the different working memory processes under investigation. Now, larger trials including follow-up examinations are needed to further explore the long-term effects of such interventions on a neural level and to estimate the clinical relevance to potentially delay cognitive decline in cognitively healthy patients with Parkinson's disease.",2020,"The intervention effect on the neural correlates was small, but decreased activation in areas relevant for working memory could be observed, with activation changes correlating with behavioural change.","[""41 cognitively healthy patients with Parkinson's disease using a newly developed working memory paradigm and functional MRI"", ""Parkinson's disease"", 'Nineteen patients', ""cognitively healthy patients with Parkinson's disease""]","['Working memory training', '5-week home-based digital working memory training intervention']","['neural efficiency', 'functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",41.0,0.0393719,"The intervention effect on the neural correlates was small, but decreased activation in areas relevant for working memory could be observed, with activation changes correlating with behavioural change.","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Giehl', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Ophey', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department of Medical Psychology, Neuropsychology and Gender Studies and Center for Neuropsychological Diagnostics and Intervention (CeNDI), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Hammes', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rehberg', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department of Medical Psychology, Neuropsychology and Gender Studies and Center for Neuropsychological Diagnostics and Intervention (CeNDI), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Lichtenstein', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department for Radiology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Reker', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department of Neurology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Eggers', 'Affiliation': 'Faculty of Medicine and University Hospital of Marburg, Department of Neurology and Center for Mind, Brain and Behavior, University of Marburg, Marburg, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Kalbe', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department of Medical Psychology, Neuropsychology and Gender Studies and Center for Neuropsychological Diagnostics and Intervention (CeNDI), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'van Eimeren', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department of Nuclear Medicine, University of Cologne, Cologne, Germany.'}]",Brain communications,['10.1093/braincomms/fcaa115']
2092,32954382,Are Demographic Factors Associated with Diabetes Risk Perception and Preventive Behavior?,"Objective


To determine the relationship between perceived diabetes susceptibility, demographic factors, diet, and physical activity.
Design


This descriptive, correlational study used multilevel modeling in a secondary analysis of data collected in a randomized controlled trial of genetic-risk testing and risk counseling for type 2 diabetes (T2DM) in primary care.
Sample


409 participants who had undergone genetic-risk testing for T2DM in primary care were randomized into either a standard risk assessment (SRA) arm for type 2 diabetes or an SRA plus results of genetic-risk testing (SRA+G) arm.
Results


Perceived diabetes susceptibility was not significantly related to demographic factors but only to fruit-and-vegetable intake at 12 months after genetic-risk counseling (p = .04). Daily servings of fruits and vegetables had a significant, positive relationship with female gender (p = .006), age (p = .02), and Hispanic ethnicity at 3 (p = .002) and 12 months after baseline (p = .01). Daily servings of fatty foods were inversely related to age at baseline (p = .02) and 3 months later. At all three timepoints, Blacks were consuming more servings of fatty foods than were other groups. A positive relationship between age and moderate activity was significant at 3 months (p = .05). Vigorous activity was inversely related to age; higher among men at all three timepoints; and higher among Hispanics at baseline (p = .0038) and 3 months later (p = .0001).
Conclusions


To plan effective, sustainable interventions, providers must understand the associations among demographic factors, individuals' risk perceptions, and lifestyle changes.",2020,Daily servings of fatty foods were inversely related to age at baseline (p = .02) and 3 months later.,"['type 2 diabetes (T2DM) in primary care', '409 participants who had undergone genetic-risk testing for T2DM in primary care']","['genetic-risk testing and risk counseling', 'standard risk assessment (SRA) arm for type 2 diabetes or an SRA plus results of genetic-risk testing (SRA+G) arm']","['Hispanic ethnicity', 'Daily servings of fatty foods', 'Vigorous activity', 'diabetes susceptibility']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0453819', 'cui_str': 'Fatty food'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",409.0,0.0256974,Daily servings of fatty foods were inversely related to age at baseline (p = .02) and 3 months later.,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Calhoun', 'Affiliation': 'School of Nursing, Duke University, Durham, North Carolina.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Vorderstrasse', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': '7081, 6815 Fayetteville, Rd. Ste. 102, Durham, North Carolina.'}]","Journal of best practices in health professions diversity : research, education and policy",[]
2093,32954412,The evening light environment in hospitals can be designed to produce less disruptive effects on the circadian system and improve sleep.,"STUDY OBJECTIVES


Blue-depleted lighting reduces the disruptive effects of evening artificial light on the circadian system in laboratory experiments, but this has not yet been shown in naturalistic settings. The aim of the current study was to test the effects of residing in an evening blue-depleted light environment (LE) on melatonin levels, sleep, neurocognitive arousal, sleepiness and potential side-effects.
METHODS


The study was undertaken in a new psychiatric hospital unit where dynamic light sources were installed. All light sources in all rooms were blue-depleted in one half of the unit between 1830h and 0700h (melanopic lux range: 7 - 21, melanopic equivalent daylight illuminance range (M-EDI): 6-19, photopic lux range: 55-124), whereas the other had standard lighting (melanopic lux range: 30-70, M-EDI range: 27-63, photopic lux range: 64-136), but was otherwise identical. Twelve healthy adults resided for five days in each light LE in a randomized cross-over trial.
RESULTS


Melatonin levels were less suppressed in the blue-depleted LE (15%) compared with the normal LE (45%) (p=0.011). DLMO was phase advanced more (1:20h) after residing in the blue-depleted LE than after the normal LE (0:46h) (p=0.008). Total sleep time was 8.1 minutes longer (p=0.032), REM sleep 13.9 minutes longer (p<0.001), and neurocognitive arousal was lower (p=0.042) in the blue-depleted LE. There were no significant differences in subjective sleepiness (p=0.16) or side-effects (p=0.09).
CONCLUSION


It is possible to create an evening light environment that has an impact on the circadian system and sleep without serious side-effects. This demonstrates the feasibility and potential benefits of designing buildings or hospital units according to chronobiological principles and provide a basis for studies in both non-clinical and clinical populations.",2020,"Total sleep time was 8.1 minutes longer (p=0.032), REM sleep 13.9 minutes longer (p<0.001), and neurocognitive arousal was lower (p=0.042) in the blue-depleted LE.","['Twelve healthy adults resided for five days in each', ' 6-19, photopic lux range: 55-124), whereas the other had standard lighting (melanopic lux range: 30-70, M-EDI range: 27-63, photopic lux range: 64-136), but was otherwise identical']","['evening blue-depleted light environment (LE', 'light LE']","['melatonin levels, sleep, neurocognitive arousal, sleepiness and potential side-effects', 'Melatonin levels', 'subjective sleepiness', 'Total sleep time', 'DLMO', 'REM sleep 13.9 minutes longer (p<0.001), and neurocognitive arousal']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0439232', 'cui_str': 'min'}]",12.0,0.049746,"Total sleep time was 8.1 minutes longer (p=0.032), REM sleep 13.9 minutes longer (p<0.001), and neurocognitive arousal was lower (p=0.042) in the blue-depleted LE.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vethe', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Scott', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Unit of Applied Clinical Research, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Sand', 'Affiliation': 'Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Olsen', 'Affiliation': 'Department of Psychology, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Morken', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Hanne S', 'Initials': 'HS', 'LastName': 'Heglum', 'Affiliation': 'Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Kaia', 'Initials': 'K', 'LastName': 'Kjørstad', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Faaland', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Cecilie L', 'Initials': 'CL', 'LastName': 'Vestergaard', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Langsrud', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Kallestad', 'Affiliation': 'Department of Mental Health, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Sleep,['10.1093/sleep/zsaa194']
2094,32954415,Frequency of injuries associated with syncope in the prevention of syncope trials.,"AIMS


Syncope can lead to injuries. We determined the frequency, severity, and predictors of injuries due to syncope in cohorts of syncope patients.
METHODS AND RESULTS


Participants were enrolled in the POST2 (fludrocortisone) and POST4 (midodrine) vasovagal syncope (VVS) randomized trials, and POST3 enrolled patients with bifascicular block and syncope. Injury was defined as minor (bruising, abrasions), moderate (lacerations), and severe (fractures, burns, joint pain), and recorded up to 1 year after enrolment. A total of 459 patients (median 39 years) were analysed. There were 710 faints occurred in 186 patients during a 1-year follow-up. Fully 56/186 (30%) of patients were injured with syncope (12% of overall group). There were 102 injuries associated with the 710 faints (14%), of which 19% were moderate or severe injuries. Neither patient age, sex, nor the presence of prodromal symptoms associated with injury-free survival. Patients with bifascicular block were more prone to injury (relative risk 1.98, P = 0.018). Patients with ≥4 faints in the prior year had more injuries than those with fewer faints (relative risk 2.97, P < 0.0001), but this was due to more frequent syncope, and not more injuries per faint. In VVS patients, pharmacological therapy significantly reduced the likelihood of an injury due to a syncopal spell (relative risk 0.64, P = 0.015). Injury severity did not associate with age, sex, or prior-year syncope frequency.
CONCLUSION


Injuries are frequent in syncope patients, but only 4% of injuries were severe. None of age, sex, and prodromal symptoms associate with injury.",2020,"Patients with bifascicular block were more prone to injury (relative risk 1.98, P = 0.018).","['459 patients (median 39\u2009years', 'Participants were enrolled in the POST2 (fludrocortisone) and POST4 (midodrine) vasovagal syncope (VVS) randomized trials, and POST3 enrolled patients with bifascicular block and syncope', 'cohorts of syncope patients']",[],"['moderate or severe injuries', 'likelihood of an injury due to a syncopal spell', 'minor (bruising, abrasions), moderate (lacerations), and severe (fractures, burns, joint pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042420', 'cui_str': 'Vasovagal syncope'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0264914', 'cui_str': 'Bifascicular block'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}]",19.0,0.0385141,"Patients with bifascicular block were more prone to injury (relative risk 1.98, P = 0.018).","[{'ForeName': 'Juliana G', 'Initials': 'JG', 'LastName': 'Jorge', 'Affiliation': 'Department of Cardiac Sciences, Libin Cardiovascular Institute of Alberta, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta T2N 4Z6, Canada.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Pournazari', 'Affiliation': 'Department of Cardiac Sciences, Libin Cardiovascular Institute of Alberta, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta T2N 4Z6, Canada.'}, {'ForeName': 'Satish R', 'Initials': 'SR', 'LastName': 'Raj', 'Affiliation': 'Department of Cardiac Sciences, Libin Cardiovascular Institute of Alberta, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta T2N 4Z6, Canada.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Maxey', 'Affiliation': 'Department of Cardiac Sciences, Libin Cardiovascular Institute of Alberta, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta T2N 4Z6, Canada.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Sheldon', 'Affiliation': 'Department of Cardiac Sciences, Libin Cardiovascular Institute of Alberta, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta T2N 4Z6, Canada.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa246']
2095,32954487,Responder Profile to Pharmaceutical-Grade Chondroitin Sulfate: An Analysis of the CONCEPT Trial.,"INTRODUCTION


The recent CONCEPT study showed that 800 mg/day of pharmaceutical-grade chondroitin sulfate (CS) was superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in patients with symptomatic knee osteoarthritis (OA). We investigate, in the present study, whether a responder profile to CS could be defined (i.e., to determine a patient's profile with the best response to treatment).
METHODS


Subjects from the CS group of the CONCEPT study were included in the present analysis. Within the CS group, various subgroups were created on the basis of different categories of age, sex, body mass index, Kellgren and Lawrence grade, age since the beginning of OA, and baseline level of pain (i.e., VAS) or function (i.e., Lequesne index). The nonparametric Kruskal-Wallis (KW) test was applied to compare the VAS pain/Lequesne index evolutions between the subgroups, and the Dwass, Steel, Critchlow, Fligner (DSCF) procedure was used to compute multiple comparisons. The impact of various covariates on the VAS pain/Lequesne index evolution was assessed by means of multiple regression.
RESULTS


Across all analyses, the probability of response to CS treatment was significantly associated with the duration between the date of diagnosis and the initiation of treatment. In other words, the shorter the interval between the diagnosis and the beginning of the treatment, the higher the response for both pain and function, particularly for patients with a duration of less than 5 years compared to patients with a duration of 10 years or more. No other criteria were found to be consistently associated with the response to CS treatment.
CONCLUSION


The treatment of OA with CS has the highest chance of success if administered in the early stage of the disease. Further research with other clinical outcomes should be carried out prior to widespread application of these findings.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03200288.",2020,"No other criteria were found to be consistently associated with the response to CS treatment.
","['Subjects from the CS group of the CONCEPT study were included in the present analysis', 'patients with symptomatic knee osteoarthritis (OA']","['OA with CS', 'pharmaceutical-grade chondroitin sulfate (CS', 'placebo', 'celecoxib']","['probability of response to CS treatment', 'Lequesne index evolution', 'pain and improving function', 'VAS pain']","[{'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0274737,"No other criteria were found to be consistently associated with the response to CS treatment.
","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, University of Liège, Liège, Belgium. olivier.bruyere@uliege.be.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Dardenne', 'Affiliation': 'Department of Biostatistics, University of Liège, Liège, Belgium.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Donneau', 'Affiliation': 'Department of Biostatistics, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, University of Liège, Liège, Belgium.'}]",Advances in therapy,['10.1007/s12325-020-01484-x']
2096,32954593,"Ramucirumab or placebo plus erlotinib in EGFR-mutated, metastatic non-small-cell lung cancer: East Asian subset of RELAY.","In the global phase III RELAY study, ramucirumab plus erlotinib (RAM+ERL) demonstrated superior progression-free survival (PFS) to placebo plus erlotinib (PL+ERL) in untreated patients with EGFR mutation-positive metastatic NSCLC (HR [95% CI]: 0.59 [0.46-0.76]). This prespecified analysis assessed RAM+ERL efficacy and safety in the RELAY subset enrolled in East Asia (Japan, Taiwan, South Korea, Hong Kong). Randomized (1:1) patients received oral ERL (150 mg/day) plus intravenous RAM (10 mg/kg) or PL Q2W. Primary endpoint was PFS (investigator-assessed). Key secondary endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. Exploratory endpoints included biomarker analyses and time to second progression (PFS2). Median PFS was 19.4 versus 12.5 months for RAM+ERL (n=166) versus PL+ERL (n=170) (HR: 0.636 [0.485-0.833]; P=0.0009). One-year PFS rate was 72.4% versus 52.2%, respectively. PFS benefit was consistent in most subgroups, including by EGFR mutation (Ex19del, Ex21.L858R). ORR and DCR were similar in both arms, but median DoR was longer with RAM+ERL. OS and PFS2 were immature at data cut-off (censoring rates, 81.2%-84.3% and 64.1%-70.5%, respectively). Grade ≥3 treatment-emergent adverse events were more frequent with RAM+ERL (70.7%) than PL+ERL (49.4%). Adverse events leading to treatment discontinuation were similar in both arms (RAM+ERL, 13.3%; PL+ERL, 12.9%), as were post-progression EGFR T790M mutation rates (43%; 50%). With superior PFS over PL+ERL and safety consistent with the overall RELAY population, RAM+ERL is a viable treatment option for EGFR-mutated metastatic NSCLC in East Asia.",2020,"PFS benefit was consistent in most subgroups, including by EGFR mutation (Ex19del, Ex21.L858R).","['RELAY subset enrolled in East Asia (Japan, Taiwan, South Korea, Hong Kong', 'EGFR-mutated, metastatic non-small-cell lung cancer']","['intravenous RAM', 'oral ERL', 'ramucirumab plus erlotinib (RAM+ERL', 'placebo plus erlotinib (PL+ERL', 'Ramucirumab or placebo plus erlotinib']","['ORR and DCR', 'PFS benefit', 'superior progression-free survival (PFS', 'Median PFS', 'biomarker analyses and time to second progression (PFS2', 'Grade ≥3 treatment-emergent adverse events', 'objective response rate (ORR), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety', 'PFS rate', 'OS and PFS2']","[{'cui': 'C0015631', 'cui_str': 'Far east country'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0526951', 'cui_str': 'ramosetron hydrochloride'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.264112,"PFS benefit was consistent in most subgroups, including by EGFR mutation (Ex19del, Ex21.L858R).","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, UCLA/TRIO-US Network, Los Angeles, CA, USA.'}, {'ForeName': 'Chao-Hua', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': 'Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Yoh', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Imamura', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Yuan', 'Initials': 'JY', 'LastName': 'Shih', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Visseren-Grul', 'Affiliation': 'Eli Lilly and Company, Utrecht, Netherlands.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Frimodt-Moller', 'Affiliation': 'Eli Lilly and Company, Copenhagen, Denmark.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Zimmermann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Gosuke', 'Initials': 'G', 'LastName': 'Homma', 'Affiliation': 'Eli Lilly Japan K.K, Kobe, Japan.'}, {'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Enatsu', 'Affiliation': 'Eli Lilly Japan K.K, Kobe, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Kindai University, Faculty of Medicine, Osaka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cancer science,['10.1111/cas.14655']
2097,32954628,"The ""Painting by Numbers Method"" for Education of Students in Crown Preparation.","INTRODUCTION


No commercially available solution to improve the teaching of a crown preparation directly on typodont teeth exists at the moment. To fill this gap and support the supervisors of dental courses, a printable and inexpensive tooth was created for structured self-assessment. The aim of this study was to test this printable tooth under realistic preclinical situations.
MATERIALS AND METHODS


A two-colored, double-layer practice tooth was developed. This tooth was consisting of a layer for a correct preparation and the crown. All printed teeth were produced with a stereolithographic printer. 35 voluntary second-year dental students in the second preclinical course in prosthodontics were randomly divided into two groups. All students had experience with typodont teeth and models. The first group was trained on four standard model teeth. The second group used model teeth for the first and fourth attempt and printed teeth for second and third attempt. The preparations of the students were scanned by an in-lab scanner and the surface deviations in contrast to a perfect preparation were measured. The differences between the first and fourth attempt were calculated. Benefits of the printed tooth were also evaluated by a questionnaire using German school grades completed by the students (1=Excellent, 2=Good, 3=Satisfactory, 4=Adequate, 5=Poor, 6=Unsatisfactory).
RESULTS


The workflow was feasible and cost-effective regarding the production of the printed teeth. The overall rating of the printed tooth in the questionnaire was good (Ø 2.1 ± 0.22). Students reported different advantages of this method in the free text. The comparison of the preparation between the first and fourth attempt showed that there was a significant better preparation with the printed teeth. The complete preparation had median values of 0.05mm (Group1: standard model tooth) and -0.03mm (Group2: printed tooth) (p=.005). Divided into single surfaces the vestibular and occlusal regions were significantly better. The vestibular surface was 0.11mm (Group1) and -0.04mm (Group2) (p=.018). The occlusal surface was 0.13mm (Group1) and -0.05mm (Group2) (p=.009).
CONCLUSIONS


The aim of this study was fulfilled. The printed tooth was tested successfully in a preclinical course. The feasibility of this teaching concept was confirmed by the questionnaire and the analysis of the preparation form. A significant difference to a standard model tooth was measurable. The students had the possibility to learn a correct crown preparation on a standardized two layered tooth with included preparation. This printed tooth enabled the students to control the crown preparation directly on their own.",2020,"The occlusal surface was 0.13mm (Group1) and -0.05mm (Group2) (p=.009).
","['35 voluntary second-year dental students in the second preclinical course in prosthodontics', 'All students had experience with typodont teeth and models', 'students had the possibility to learn a correct crown preparation on a standardized two layered tooth with included preparation']",[],"['overall rating of the printed tooth', 'occlusal surface', 'vestibular surface']","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0033590', 'cui_str': 'Prosthodontics'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",35.0,0.0217737,"The occlusal surface was 0.13mm (Group1) and -0.05mm (Group2) (p=.009).
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Höhne', 'Affiliation': 'The Department of Prosthodontics, University of Würzburg, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Jentzsch', 'Affiliation': 'The Department of Prosthodontics, University of Würzburg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schmitter', 'Affiliation': 'The Department of Prosthodontics, University of Würzburg, Germany.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12599']
2098,32954647,Qishen Yiqi dripping pills for chronic ischaemic heart failure: results of the CACT-IHF randomized clinical trial.,"AIMS


Qishen Yiqi dripping pills (QSYQ) may be beneficial in patients with ischaemic heart failure (IHF). We aimed to assess the efficacy and safety of QSYQ administered together with guideline-directed medical therapy in patients with IHF.
METHODS AND RESULTS


This prospective randomized, double-blind, multicentre placebo-controlled study enrolled 640 patients with IHF between March 2012 and August 2014. Patients were randomly assigned to receive 6 months of QSYQ or placebo in addition to standard treatment. The primary outcome was 6 min walking distance at 6 months. Among the 638 IHF patients (mean age 65 years, 72% men), the 6 min walking distance increased from 336.15 ± 100.84 to 374.47 ± 103.09 m at 6 months in the QSYQ group, compared with 334.40 ± 100.27 to 340.71 ± 104.57 m in the placebo group (mean change +38.32 vs. +6.31 m respectively; P < 0.001). The secondary outcomes in composite clinical events, including all-cause mortality and emergency treatment/hospitalization due to heart failure, were non-significantly lower at 6 months with QSYQ compared with placebo (13% vs. 17%; P = 0.45), and the change of brain natriuretic peptide was non-significantly greater with QSYQ compared with placebo (median change -14.55 vs. -12.30 pg/mL, respectively; P = 0.21). By contrast, the Minnesota Living with Heart Failure Questionnaire score significantly improved with QSYQ compared with placebo (-11.78 vs. -9.17; P = 0.004). Adverse events were minor and infrequent with QSYQ, similar to the placebo group.
CONCLUSIONS


Treatment with QSYQ for 6 months in addition to standard therapy improved exercise tolerance of IHF patients and was well tolerated.",2020,"By contrast, the Minnesota Living with Heart Failure Questionnaire score significantly improved with QSYQ compared with placebo (-11.78 vs. -9.17; P = 0.004).","['640 patients with IHF between March 2012 and August 2014', '638 IHF patients (mean age 65\xa0years, 72% men', 'chronic ischaemic heart failure', 'patients with IHF', 'patients with ischaemic heart failure (IHF']","['QSYQ', 'guideline-directed medical therapy', 'Qishen Yiqi dripping pills', 'Qishen Yiqi dripping pills (QSYQ', 'placebo', 'QSYQ or placebo']","['composite clinical events, including all-cause mortality and emergency treatment/hospitalization due to heart failure', 'efficacy and safety', 'Adverse events', '6\xa0min walking distance', 'Minnesota Living with Heart Failure Questionnaire score', 'tolerated', 'exercise tolerance', 'change of brain natriuretic peptide']","[{'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C2353453', 'cui_str': 'qishen yiqi'}, {'cui': 'C0452837', 'cui_str': 'Dripping'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0013969', 'cui_str': 'Emergency treatment'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]",640.0,0.391407,"By contrast, the Minnesota Living with Heart Failure Questionnaire score significantly improved with QSYQ compared with placebo (-11.78 vs. -9.17; P = 0.004).","[{'ForeName': 'Jingyuan', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital of Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore and Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Henan, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Shutao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Zhongyong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Jiangxi, China.'}, {'ForeName': 'Fengrong', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Liaoning, China.'}, {'ForeName': 'Yonggang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, Shaanxi, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': 'The First Affiliated Hospital of Anhui University of Chinese Medicine, Anhui, China.'}, {'ForeName': 'Tianfu', 'Initials': 'T', 'LastName': 'Niu', 'Affiliation': 'Shanxi Traditional Chinese Medical Hospital, Shanxi, China.'}, {'ForeName': 'Dongqing', 'Initials': 'D', 'LastName': 'An', 'Affiliation': 'Traditional Chinese Medical Hospital of Xinjiang Uygur Autonomous Region, Xinjiang, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': 'Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'The Second Affiliated Hospital of Guiyang College of Traditional Chinese Medicine, Guizhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': 'The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Liaoning, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Affiliated Nanhua Hospital, University of South China, Hunan, China.'}, {'ForeName': 'Fengru', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Ruihong', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Yingqiang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Tiemin', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': ""Affiliated Hospital of Logistics University of Chinese People's Armed Police Force, Tianjin, China.""}, {'ForeName': 'Yuhui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital of Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Xianliang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Yazhu', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Su', 'Affiliation': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Baohe', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Boli', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}]",ESC heart failure,['10.1002/ehf2.12980']
2099,32954688,Oral nano-curcumin on gingival inflammation in patients with gingivitis and mild periodontitis.,"Gingivitis can trigger gingival diseases such as periodontitis. Since the complete removal of microbial plaques by mechanical procedures is not conceivable in some conditions and also chemical mouthwashes have a lot of side effects, finding a new treatment strategy would be useful. In the present study, for the first time, the effects of oral nano-curcumin on gingival inflammation in patients with gingivitis and mild periodontitis were assessed. Forty eight patients with gingivitis and mild periodontitis participated in this clinical trial. In one group the patients were treated with Sina curcumin capsules 80 mg and the other group received a placebo. Clinical parameters, including modified gingival index, papillary bleeding index, and plaque index were determined on days 0, 7, 14, and 28. There were no significant differences in age, sex, papillary bleeding index (PBI), and modified gingival index (MGI) between the two groups at baseline. There was a dropout of two patients (both from the placebo group). The MGI and PBI have a significantly decreasing trend in both case and control groups and the decreases were severe in the case group. The differences between PBI and MGI in the two groups were significant at 14 and 28 days. The plaque index did not significantly change in either group over the study period. The trend of changes in plaque index was not different between the two groups of the study. In the current study, no side effect was found in the patients. Oral nano-curcumin has positive effects on the decrease of inflammation and gingival bleeding in patients with gingivitis and mild periodontitis. Nano-curcumin capsules have a systemic target site with more bioavailability than topical forms.",2020,Oral nano-curcumin has positive effects on the decrease of inflammation and gingival bleeding in patients with gingivitis and mild periodontitis.,"['patients with gingivitis and mild periodontitis', 'Forty eight patients with gingivitis and mild periodontitis']","['Oral nano-curcumin', 'placebo', 'oral nano-curcumin']","['gingival inflammation', 'inflammation and gingival bleeding', 'plaque index', 'age, sex, papillary bleeding index (PBI), and modified gingival index (MGI', 'modified gingival index, papillary bleeding index, and plaque index', 'PBI and MGI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}]",48.0,0.0269231,Oral nano-curcumin has positive effects on the decrease of inflammation and gingival bleeding in patients with gingivitis and mild periodontitis.,"[{'ForeName': 'Meisam', 'Initials': 'M', 'LastName': 'Malekzadeh', 'Affiliation': 'Dental Sciences Research Center, Department of Periodontics, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Seyed Javad', 'Initials': 'SJ', 'LastName': 'Kia', 'Affiliation': 'Dental Sciences Research Center, Department of Oral and Maxillofacial Medicine, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Mashaei', 'Affiliation': 'Dentist, Rasht, Iran.'}, {'ForeName': 'Mahdieh-Sadat', 'Initials': 'MS', 'LastName': 'Moosavi', 'Affiliation': 'Dental Research Center, Dental Research Institute, Department of Oral and Maxillofacial Medicine, Faculty of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}]",Clinical and experimental dental research,['10.1002/cre2.330']
2100,32954697,Perinatal Outcomes in Infants of Mothers with Diabetes in Pregnancy.,"BACKGROUND


The incidence of gestational diabetes mellitus (GDM) is increasing in parallel to the worldwide obesity and type 2 diabetes pandemic. Both GDM and pre-gestational diabetes mellitus (PGDM) are associated with short- and long-term consequences in the offspring. There are few recent studies addressing outcomes of newborns born to women diagnosed with GDM and PGDM in Israel.
OBJECTIVES


To assess perinatal complications in offspring of women with GDM and PGDM.
METHODS


The authors conducted a single-center retrospective case-control study of outcomes of all newborns whose mothers had been diagnosed with diabetes in pregnancy compared to randomly assigned controls born on the same date, whose mothers had no diabetes.
RESULTS


In the study period 2015-2017, 526 mothers diagnosed with GDM or PGDM and their newborn infants were identified. The authors randomly assigned 526 control infants. The rate of women with diabetes in pregnancy was 5.0%. Mothers with GDM and PGDM had higher rates of pre-eclampsia, multiple pregnancies, and preterm deliveries. Mothers with PGDM had significantly higher rates of intrauterine fetal demise (4.3%), congenital anomalies (12.8%), and small-for-gestational-age neonates (10.6%) compared to controls (0%, 3.2%, and 4.2%, respectively, P < 0.001). The risks for preterm or cesarean delivery, large-for-gestational-age neonate, respiratory morbidity, hypoglycemia, and polycythemia were increased in offspring of mothers with diabetes, especially PGDM.
CONCLUSIONS


Despite all the advancements in prenatal care, diabetes in pregnancy, both PGDM and GDM, is still associated with significant morbidities and complications in offspring. Better preconception and inter-pregnancy care might reduce these risks.",2020,"Mothers with GDM and PGDM had higher rates of pre-eclampsia, multiple pregnancies, and preterm deliveries.","['newborns born to women diagnosed with GDM and PGDM in Israel', 'all newborns whose mothers had been diagnosed with diabetes in pregnancy compared to randomly assigned controls born on the same date, whose mothers had no diabetes', 'offspring of women with GDM and PGDM', 'Mothers with GDM and', 'gestational diabetes mellitus (GDM', '526 mothers diagnosed with GDM or PGDM and their newborn infants', 'Infants of Mothers with Diabetes in Pregnancy']",['PGDM'],"['rates of pre-eclampsia, multiple pregnancies, and preterm deliveries', 'congenital anomalies', 'rate of women with diabetes in pregnancy', 'perinatal complications', 'rates of intrauterine fetal demise', 'risks for preterm or cesarean delivery, large-for-gestational-age neonate, respiratory morbidity, hypoglycemia, and polycythemia']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0032989', 'cui_str': 'Multiple pregnancy'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0032461', 'cui_str': 'Polycythaemia'}]",526.0,0.063082,"Mothers with GDM and PGDM had higher rates of pre-eclampsia, multiple pregnancies, and preterm deliveries.","[{'ForeName': 'Arieh', 'Initials': 'A', 'LastName': 'Riskin', 'Affiliation': 'Department of Neonatology, Bnai Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Itzchaki', 'Affiliation': 'Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bader', 'Affiliation': 'Department of Neonatology, Bnai Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Adir', 'Initials': 'A', 'LastName': 'Iofe', 'Affiliation': 'Department of Neonatology, Bnai Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Arina', 'Initials': 'A', 'LastName': 'Toropine', 'Affiliation': 'Department of Neonatology, Bnai Zion Medical Center, Haifa, Israel.'}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Riskin-Mashiah', 'Affiliation': 'Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.'}]",The Israel Medical Association journal : IMAJ,[]
2101,32954753,Effects of different positive end-expiratory pressure titrating strategies on oxygenation and respiratory mechanics during one- lung ventilation: a randomized controlled trial.,"BACKGROUND


Positive end-expiratory pressure (PEEP) is widely used to reduce the risk of hypoxemia and atelectasis during one-lung ventilation (OLV); however, the optimal strategy for PEEP titrating remains unclear.The purpose of the study was to investigate the effects of different PEEP titrating strategies on oxygenation and respiratory mechanics during OLV.
METHODS


Patients undergoing thoracic surgery with general anesthesia were randomly allocated into five groups. In P0 group, PEEP was set to zero; in PLIP2 group, PEEP was set to 2 cmH2O plus the pressure of lower inflection point (LIP) of pressure-volume (P-V) curve; in PLIPS group, PEEP was titrated to achieve maximum static compliance from the averaged LIP pressure value; in groups PSTAT and PDYN, the incremental PEEP values were titrated to achieve maximum static compliance or maximum dynamic compliance from 4 cmH2O. Hemodynamic measurements, respiratory mechanics, and blood gas analyses were recorded at the beginning of OLV, OLV 15 min, OLV 30 min, OLV 45 min, and OLV 60 min. Also, the intrapulmonary shunt (Qs/Qt), physiological dead space to tidal volume ratio (VD/VT), and oxygenation index (OI) were calculated and compared.
RESULTS


Seventy-five patients consented to participate in this study. Dynamic compliance, peak inspiratory pressure (PIP), and plateau inspiratory pressure (Pplat) increased after PEEP titration during OLV. PIP, Qs/ Qt, and OI showed no differences among groups. Group PDYN showed lower Pplat, lower driving pressure, and higher dynamic compliance when compared with zero PEEP group.
CONCLUSIONS


The PEEP titrating strategy according to dynamic compliance can improve respiratory mechanics, whereas it has no significant effects on oxygenation, dead space ratio, and intrapulmonary shunt, suggesting that it is better during OLV for thoracic surgery.",2020,"Group PDYN showed lower Pplat, lower driving pressure, and higher dynamic compliance when compared with zero PEEP group.
","['one- lung ventilation', 'Patients undergoing thoracic surgery with general anesthesia', 'Seventy-five patients consented to participate in this study']","['PEEP titrating strategies', 'positive end-expiratory pressure titrating strategies', 'Positive end-expiratory pressure (PEEP']","['pressure of lower inflection point (LIP) of pressure-volume', 'oxygenation and respiratory mechanics', 'lower Pplat, lower driving pressure, and higher dynamic compliance', 'Dynamic compliance, peak inspiratory pressure (PIP), and plateau inspiratory pressure (Pplat', 'maximum static compliance or maximum dynamic compliance from 4 cmH2O. Hemodynamic measurements, respiratory mechanics, and blood gas analyses', 'intrapulmonary shunt (Qs/Qt), physiological dead space to tidal volume ratio (VD/VT), and oxygenation index (OI']","[{'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C3697386', 'cui_str': 'Airway plateau pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0429680', 'cui_str': 'Dynamic compliance'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429681', 'cui_str': 'Static lung compliance'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0204901', 'cui_str': 'Hemodynamic measurements'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0489642', 'cui_str': 'Intrapulmonary shunt'}, {'cui': 'C0231975', 'cui_str': 'Physiological dead space'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}]",75.0,0.0397109,"Group PDYN showed lower Pplat, lower driving pressure, and higher dynamic compliance when compared with zero PEEP group.
","[{'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital of Nanjing Medical University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lianhua', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Shitong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital of Nanjing Medical University, Shanghai, China. 610619770@139.com.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lian', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China. ming.lian@shgh.cn.'}]",Annals of palliative medicine,['10.21037/apm-19-441']
2102,32954762,The management of hemiplegic shoulder pain in stroke subjects undergoing pulsed radiofrequency treatment of the suprascapular and axillary nerves: a pilot study.,"BACKGROUND


Our trial aims to provide evidence for pain management and rehabilitation in patients with hemiplegic shoulder pain (HSP). HSP is one of the most common pains and disabilities occurring after a stroke. With accumulating evidence, the management of the suprascapular nerve (SSN) or axillary nerve (AN) might effectively relieve the pain and disability associated with HSP. However, no study has compared the effects of pulsed radiofrequency and nerve block of SSN and AN.
METHODS


Twenty patients with chronic stroke (over one year from onset) and HSP [visual analog scale (VAS) for pain ≥30 mm] randomly underwent ultrasound-guided SSN and AN pulsed radiofrequency or nerve block treatment. All patients were evaluated before treatment (T0) and at 4 (T1) and 16 (T2) weeks of follow-up. The primary outcome was the VAS score. Secondary outcomes were the Modified Ashworth Scale (MAS) score, passive shoulder range of motion (PROM), Disability Assessment Scale (DAS) score, and EuroQol-5 dimension questionnaire (EQ-5D).
RESULTS


Significant improvements in the VAS score were observed in both groups at T1 and T2. However, a significant difference was not observed between the two groups (T1: P=0.43; T2: P=0.23). No statistically significant differences were observed in the MAS score between the two groups at T1 (P=0.06) and T2 (P=0.07). In the PROM of shoulder abduction and external rotation, statistically, significant differences were observed between the two groups at T1 (P=0.02*, & P=0.04*) and T2 (P=0.02*, & P=0.00*). Statistically significant differences in shoulder flexion and extension were not observed between the two groups at T1 (P=0.23, & P=0.35) and T2 (P=0.14, & P=0.14). Statistically significant differences in the DAS score were not observed between the 2 groups at T1 (P=0.51, & P=0.33, & P=0.36, & P=0.75) and T2 (P=0.12, & P=0.54, & P=0.41, & P=0.86). No statistically significant differences in the EQ-5D responses were observed between the two groups at T1 (P=0.42) and T2 (P=0.11).
CONCLUSIONS


Pulsed radiofrequency of SSN and AN achieves similar therapeutic effects to the nerve block. Pulsed radiofrequency modulation is superior to nerve block in improving the PROM of shoulder abduction and external rotation.",2020,"In the PROM of shoulder abduction and external rotation, statistically, significant differences were observed between the two groups at T1 (P=0.02*, & P=0.04*) and T2 (P=0.02*, & P=0.00*).","['stroke subjects undergoing', 'patients with hemiplegic shoulder pain (HSP', 'Twenty patients with chronic stroke (over one year from onset) and HSP [visual analog scale (VAS) for pain ≥30 mm] randomly underwent']","['pulsed radiofrequency and nerve block of SSN', 'ultrasound-guided SSN and AN pulsed radiofrequency or nerve block treatment', 'HSP', 'Pulsed radiofrequency modulation', 'pulsed radiofrequency treatment of the suprascapular and axillary nerves']","['Modified Ashworth Scale (MAS) score, passive shoulder range of motion (PROM), Disability Assessment Scale (DAS) score, and EuroQol-5 dimension questionnaire (EQ-5D', 'EQ-5D responses', 'MAS score', 'DAS score', 'VAS score', 'hemiplegic shoulder pain', 'shoulder flexion and extension']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}, {'cui': 'C0228885', 'cui_str': 'Structure of axillary nerve'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]","[{'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",20.0,0.0661042,"In the PROM of shoulder abduction and external rotation, statistically, significant differences were observed between the two groups at T1 (P=0.02*, & P=0.04*) and T2 (P=0.02*, & P=0.00*).","[{'ForeName': 'Congxian', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Analgesia Department of Shandong Provincial Hospital Affiliated to the Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Imaging Department of Shandong Provincial Hospital Affiliated to the Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Analgesia Department of Qingdao Municipal Hospital, Qingdao, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Yidu Central Hospital, Weifang, China.'}, {'ForeName': 'Shengtao', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Analgesia Department of Shandong Provincial Hospital Affiliated to the Shandong First Medical University, Jinan, China. wshengt@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1618']
2103,32954832,Value-based approach to blood pressure telemonitoring and remote counseling in hypertensive patients.,"PURPOSE


Blood pressure telemonitoring and remote counselling (BPTM) improves blood pressure (BP) control in patients with hypertension (HTN). Studies assessing the efficacy of BPTM from a value-based perspective are lacking. We investigated whether BPTM fits all principles of the value-based approach (clinical and economic effectiveness, improvement in patient-reported outcome/experience measures (PROM/PREM)).
MATERIALS AND METHODS


Two hundred and forty ambulatory patients with uncontrolled HTN were randomised in a 2: 1 manner to BPTM ( n  = 160, mean age 47 y.o.) and usual care (UC,  n  = 80; 49 y.o.) with baseline and 3-month follow-up clinic visits. BPTM employed a mobile application (for patients) and a desktop version (for clinician), which allowed communication and exchange of medical data. The main outcomes were changes in office and ambulatory systolic (S) BPs, rate of BP control. The incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were evaluated in economic analysis. The MOS SF-36 score was taken as a PROM, and the PEQ score was used as a PREM.
RESULTS


Larger decreases in office and ambulatory SBPs (-16.8 and -8.9 mm Hg, respectively;  p  < .05) was achieved in BPTM group while the treatment intensity was equal (2.4 drugs). The ICER 11.1 EUR/-1 mm Hg 24-hour SBP/1 year was 75% effective as per willingness-to-pay threshold. BPTM improved PROM (+2.1 in mean MOS SF-36;  p  = .04), reduced long-term mortality (+0.11 life years gained), leading to +0.49 quality-adjusted life years (QALYs) gained as compared with UC. The ICUR was 4 169.4 EUR/QALY gained. Patient-reported experience was higher in the BPTM (+10 PEQ,  p  = .01). The UC group showed minor changes in MOS SF-36 and PEQ (+1.3; +6, respectively;  p  n.s.).
CONCLUSIONS


Being cost-effective, BPTM incorporates both clinical benefits and patient-perceived value. Larger randomised studies are needed to confirm our findings.",2020,"BPTM improved PROM (+2.1 in mean MOS SF-36;  p  = .04), reduced long-term mortality (+0.11 life years gained), leading to +0.49 quality-adjusted life years (QALYs) gained as compared with UC.","['patients with hypertension (HTN', 'Two hundred and forty ambulatory patients with uncontrolled HTN', 'hypertensive patients']","['Blood pressure telemonitoring and remote counselling (BPTM', 'Value-based approach to blood pressure telemonitoring and remote counseling', 'usual care (UC,  n \u2009=\u200980; 49\u2009y.o.) with baseline and 3-month follow-up clinic visits', 'BPTM']","['office and ambulatory SBPs', 'MOS SF-36 and PEQ', 'reduced long-term mortality', 'changes in office and ambulatory systolic (S) BPs, rate of BP control', 'incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR', 'MOS SF-36 score', 'BPTM improved PROM', 'blood pressure (BP) control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026574', 'cui_str': 'mos Oncogenes'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1849718', 'cui_str': 'Autosomal recessive popliteal pterygium syndrome'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}]",240.0,0.0434034,"BPTM improved PROM (+2.1 in mean MOS SF-36;  p  = .04), reduced long-term mortality (+0.11 life years gained), leading to +0.49 quality-adjusted life years (QALYs) gained as compared with UC.","[{'ForeName': 'Mikhail V', 'Initials': 'MV', 'LastName': 'Ionov', 'Affiliation': 'Almazov National Medical Research Center, Ministry of Health of the Russian Federation, Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Zhukova', 'Affiliation': 'Ministry of Health of the Russian Federation, Privolzhsky Research Medical University, Nizhny Novgorod, Russian Federation.'}, {'ForeName': 'Yulia S', 'Initials': 'YS', 'LastName': 'Yudina', 'Affiliation': 'Almazov National Medical Research Center, Ministry of Health of the Russian Federation, Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Natalya G', 'Initials': 'NG', 'LastName': 'Avdonina', 'Affiliation': 'Almazov National Medical Research Center, Ministry of Health of the Russian Federation, Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Igor V', 'Initials': 'IV', 'LastName': 'Emelyanov', 'Affiliation': 'Almazov National Medical Research Center, Ministry of Health of the Russian Federation, Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Dmitri I', 'Initials': 'DI', 'LastName': 'Kurapeev', 'Affiliation': 'Almazov National Medical Research Center, Ministry of Health of the Russian Federation, Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Nadezhda E', 'Initials': 'NE', 'LastName': 'Zvartau', 'Affiliation': 'Almazov National Medical Research Center, Ministry of Health of the Russian Federation, Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Alexandra O', 'Initials': 'AO', 'LastName': 'Konradi', 'Affiliation': 'Almazov National Medical Research Center, Ministry of Health of the Russian Federation, Saint-Petersburg, Russian Federation.'}]",Blood pressure,['10.1080/08037051.2020.1813015']
2104,32954885,Effects of Home-Based Cardiac Rehabilitation on Time to Enrollment and Functional Status in Patients With Ischemic Heart Disease.,"Background Cardiac rehabilitation is an established performance measure for adults with ischemic heart disease, but patient participation is remarkably low. Home-based cardiac rehabilitation (HBCR) may be more practical and feasible, but evidence regarding its efficacy is limited. We sought to compare the effects of HBCR versus facility-based cardiac rehabilitation (FBCR) on functional status in patients with ischemic heart disease. Methods and Results This was a pragmatic trial of 237 selected patients with a recent ischemic heart disease event, who enrolled in HBCR or FBCR between August 2015 and September 2017. The primary outcome was 3-month change in distance completed on a 6-minute walk test. Secondary outcomes included rehospitalization as well as patient-reported physical activity, quality of life, and self-efficacy. Characteristics of the 116 patients enrolled in FBCR and 121 enrolled in HBCR were similar, except the mean time from index event to enrollment was shorter for HBCR (25 versus 77 days;  P <0.001). As compared with patients undergoing FBCR, those in HBCR achieved greater 3-month gains in 6-minute walk test distance (+95 versus +41 m;  P <0.001). After adjusting for demographics, comorbid conditions, and indication, the mean change in 6-minute walk test distance remained significantly greater for patients enrolled in HBCR (+101 versus +40 m;  P <0.001). HBCR participants reported greater improvements in quality of life and physical activity but less improvement in exercise self-efficacy. There were no deaths or cardiovascular hospitalizations. Conclusions Patients enrolled in HBCR achieved greater 3-month functional gains than those enrolled in FBCR. Our data suggest that HBCR may safely derive equivalent benefits in exercise capacity and overall program efficacy in selected patients. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02105246.",2020,"As compared with patients undergoing FBCR, those in HBCR achieved greater 3-month gains in 6-minute walk test distance (+95 versus +41 m;  P <0.001).","['patients with ischemic heart disease', 'Patients With Ischemic Heart Disease', '116 patients enrolled in FBCR and 121 enrolled in HBCR', '237 selected patients with a recent ischemic heart disease event, who enrolled in HBCR or FBCR between August 2015 and September 2017', 'adults with ischemic heart disease']","['HBCR', 'Home-based cardiac rehabilitation (HBCR', 'HBCR versus facility-based cardiac rehabilitation (FBCR', ' Cardiac rehabilitation', 'Home-Based Cardiac Rehabilitation']","['3-month change in distance completed on a 6-minute walk test', 'exercise capacity and overall program efficacy', '6-minute walk test distance', 'quality of life and physical activity', 'rehospitalization as well as patient-reported physical activity, quality of life, and self-efficacy', 'exercise self-efficacy', 'mean change in 6-minute walk test distance', 'deaths or cardiovascular hospitalizations', '3-month functional gains']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",237.0,0.104893,"As compared with patients undergoing FBCR, those in HBCR achieved greater 3-month gains in 6-minute walk test distance (+95 versus +41 m;  P <0.001).","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Schopfer', 'Affiliation': 'Department of Medicine University of California, San Francisco CA.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Whooley', 'Affiliation': 'Department of Medicine University of California, San Francisco CA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Allsup', 'Affiliation': 'Department of Medicine VA Pittsburgh Healthcare System Pittsburgh PA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pabst', 'Affiliation': 'Department of Medicine University of California, San Francisco CA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Department of Medicine University of California, San Francisco CA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Tarasovsky', 'Affiliation': 'Department of Medicine San Francisco VA Health Care System San Francisco CA.'}, {'ForeName': 'Claire S', 'Initials': 'CS', 'LastName': 'Duvernoy', 'Affiliation': 'Division of Cardiology Department of Medicine University of Michigan Ann Arbor MI.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Forman', 'Affiliation': 'Department of Medicine VA Pittsburgh Healthcare System Pittsburgh PA.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016456']
2105,32954927,"Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE).","PURPOSE


Many patients with HR+, HER2- early breast cancer (EBC) will not experience recurrence or have distant recurrence with currently available standard therapies. However, up to 30% of patients with high-risk clinical and/or pathologic features may experience distant recurrence, many in the first few years. Superior treatment options are needed to prevent early recurrence and development of metastases for this group of patients. Abemaciclib is an oral, continuously dosed, CDK4/6 inhibitor approved for HR+, HER2- advanced breast cancer (ABC). Efficacy and safety of abemaciclib in ABC supported evaluation in the adjuvant setting.
METHODS


This open-label, phase III study included patients with HR+, HER2-, high-risk EBC, who had surgery and, as indicated, radiotherapy and/or adjuvant/neoadjuvant chemotherapy. Patients with four or more positive nodes, or one to three nodes and either tumor size ≥ 5 cm, histologic grade 3, or central Ki-67 ≥ 20%, were eligible and randomly assigned (1:1) to standard-of-care adjuvant endocrine therapy (ET) with or without abemaciclib (150 mg twice daily for 2 years). The primary end point was invasive disease-free survival (IDFS), and secondary end points included distant relapse-free survival, overall survival, and safety.
RESULTS


At a preplanned efficacy interim analysis, among 5,637 randomly assigned patients, 323 IDFS events were observed in the intent-to-treat population. Abemaciclib plus ET demonstrated superior IDFS versus ET alone ( P  = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively. Safety data were consistent with the known safety profile of abemaciclib.
CONCLUSION


Abemaciclib when combined with ET is the first CDK4/6 inhibitor to demonstrate a significant improvement in IDFS in patients with HR+, HER2- node-positive EBC at high risk of early recurrence.",2020,"Abemaciclib plus ET demonstrated superior IDFS versus ET alone ( P  = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively.","['patients with HR+, HER2-, high-risk EBC, who had surgery and, as indicated', 'Patients with four or more positive nodes, or one to three\u202fnodes and either tumor size ≥ 5 cm, histologic grade 3, or central Ki-67 ≥ 20', 'patients with HR+, HER2- early breast cancer (EBC']","['CDK4/6 inhibitor', 'Abemaciclib Combined With Endocrine Therapy', 'standard-of-care adjuvant endocrine therapy (ET) with or without abemaciclib', 'radiotherapy and/or adjuvant/neoadjuvant chemotherapy']","['invasive disease-free survival (IDFS), and secondary end points included distant relapse-free survival, overall survival, and safety', 'Efficacy and safety', '2-year IDFS rates', 'IDFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0919553', 'cui_str': 'Histologic grade'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}]",5637.0,0.075697,"Abemaciclib plus ET demonstrated superior IDFS versus ET alone ( P  = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively.","[{'ForeName': 'Stephen R D', 'Initials': 'SRD', 'LastName': 'Johnston', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Department of Obstetrics and Gynecology, Breast Center, LMU University Hospital, Munich, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Clinica Pesquisas e Centro São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Hospital General Universitario Gregorio Marañon, Universidad Complutense, Ciberonc, GEICAM, Madrid, Spain.'}, {'ForeName': 'Zhi Min', 'Initials': 'ZM', 'LastName': 'Shao', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qing Yuan', 'Initials': 'QY', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jorge Luis', 'Initials': 'JL', 'LastName': 'Martinez Rodriguez', 'Affiliation': 'Alivia Clinica de Alta Especialidad, Nuevo Leon, Mexico.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Institut de Cancérologie de l'Ouest Pays de la Loire, Saint Herblain-Angers, France.""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Seoul, Korea.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Guarneri', 'Affiliation': 'Department of Surgery, Oncology, and Gastroenterology, University of Padova, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Boyle', 'Affiliation': 'Mater Hospital Sydney, Patricia Ritchie Centre for Cancer Care and Research, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Universitaire Ziekenhuizen Leuven-Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': ""IOB Institute of Oncology, Quiron Group, Madrid, Barcelona, and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Breast Center, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wardley', 'Affiliation': 'NIHR Manchester Clinical Research Facility at The Christie, and Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology Medicine and Health, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Trakya University Faculty of Medicine, Edirne, Turkey.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Smith', 'Affiliation': 'Artios Pharma, Cambridge, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Frenzel', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Desirée', 'Initials': 'D', 'LastName': 'Headley', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wei', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'San Antonio', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Hulstijn', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Eli Lilly, Indianapolis, IN.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'University of Pittsburgh, NSABP Foundation, Pittsburgh, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.02514']
2106,32954992,"Efficacy of an orally administered combination of  Lactobacillus paracasei  LC11, cranberry and D-mannose for the prevention of uncomplicated, recurrent urinary tract infections in women.","BACKGROUND


Most women experience a urinary tract infection (UTI) at least once in their lifetime. The present study determined the efficacy and safety of a combination of  Lactobacillus paracasei LC11 , cranberry and D-mannose (Lactoflorene Cist ® ) in the prophylaxis of recurrent uncomplicated UTIs in premenopausal women.
METHODS


This single-centre study enrolled premenopausal women aged 18-50 years with an acute UTI and a history of recurrent uncomplicated UTIs. Patients were first treated with fosfomycin (3 g once a day for 2 days) to eliminate any underlying infection, followed by treatment with Lactoflorene Cist ®  once a day for 10 days/month for 90 days (Group 1), Lactoflorene Cist ®  once daily for 90 days (Group 2) or no treatment (Group 3; control). The main study endpoint was the rate of UTI recurrence during the study period. Any adverse events with treatment were also recorded.
RESULTS


A total of 55 women (mean age 39.3 years; range: 20-46) were enrolled in the study. A significantly higher proportion of patients in the control group experienced UTIs during the study period compared with the two treatment groups (52.9% vs 16.0% in Group 1 and 15.5% in group 2;  p  < 0.01). Similarly, a higher proportion of patients in Group 1 (65.8%) and Group 2 (68.7%) remained UTI-free during the study versus the control group. No adverse events were reported in the treated patients.
CONCLUSION


Prophylactic treatment with Lactoflorene Cist ®  was effective and safe in the management of recurrent uncomplicated UTIs in premenopausal women.",2020,A significantly higher proportion of patients in the control group experienced UTIs during the study period compared with the two treatment groups (52.9% vs 16.0% in Group 1 and 15.5% in group 2;  p  < 0.01).,"['55 women (mean age 39.3\u2009years; range: 20-46', 'women', 'enrolled premenopausal women aged 18-50\u2009years with an acute UTI and a history of recurrent uncomplicated UTIs', 'premenopausal women']","['fosfomycin ', 'Lactoflorene Cist ®  once daily for 90\u2009days (Group 2) or no treatment', 'Lactoflorene Cist ®', 'Lactobacillus paracasei  LC11, cranberry and D-mannose', 'Lactobacillus paracasei LC11 , cranberry and D-mannose (Lactoflorene Cist ® ']","['efficacy and safety', 'adverse events', 'rate of UTI recurrence']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0242147', 'cui_str': 'Acute urinary tract infection'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]","[{'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0024742', 'cui_str': 'Mannose'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",55.0,0.0340686,A significantly higher proportion of patients in the control group experienced UTIs during the study period compared with the two treatment groups (52.9% vs 16.0% in Group 1 and 15.5% in group 2;  p  < 0.01).,"[{'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Murina', 'Affiliation': 'Lower Genital Tract Disease Unit, V. Buzzi Hospital-University of Studies of Milan, Milan, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Vicariotto', 'Affiliation': 'Lower Genital Tract Disease Unit, V. Buzzi Hospital-University of Studies of Milan, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Lubrano', 'Affiliation': 'Lower Genital Tract Disease Unit, V. Buzzi Hospital-University of Studies of Milan, Milan, Italy.'}]",Urologia,['10.1177/0391560320957483']
2107,32954994,Facilitating Sexual Assault Reporting on the College Campus: The Role of Procedural Justice in Bystander Decisions to Provide Police Referrals.,"Using a randomly assigned 2 (victim race) × 2 (alcohol consumption) between-subjects factorial design, this study used surveys from a sample of 571 undergraduate students at a mid-sized, public university in the United States to determine the effect of procedural justice on police referral after reading a sexual assault disclosure vignette. Multivariate binary logistic regression models demonstrated that positive perceptions of procedural justice increased police referral following sexual assault disclosure. Victim alcohol consumption and rape myth acceptance decreased police referral. Victim race, victim alcohol consumption, and participant sex did not moderate the effect of procedural justice on police referral. Implications are discussed.",2020,"Victim race, victim alcohol consumption, and participant sex did not moderate the effect of procedural justice on police referral.","['571 undergraduate students at a mid-sized, public university in the United States to determine the effect of procedural justice on police referral after reading a sexual assault disclosure vignette', 'College Campus']",[],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0557806', 'cui_str': 'College'}]",[],[],571.0,0.0168978,"Victim race, victim alcohol consumption, and participant sex did not moderate the effect of procedural justice on police referral.","[{'ForeName': 'Tri Keah S', 'Initials': 'TKS', 'LastName': 'Henry', 'Affiliation': 'Indiana University Bloomington, USA.'}, {'ForeName': 'Travis W', 'Initials': 'TW', 'LastName': 'Franklin', 'Affiliation': 'Sam Houston State University, Huntsville, TX, USA.'}, {'ForeName': 'Cortney A', 'Initials': 'CA', 'LastName': 'Franklin', 'Affiliation': 'Sam Houston State University, Huntsville, TX, USA.'}]",Violence against women,['10.1177/1077801220954289']
2108,32955013,The efficacy of a patient decision aid for improving person-centered decision-making in older adults with obstructive sleep apnea.,"STUDY OBJECTIVES


Person-centered obstructive sleep apnea (OSA) care is a collaborative approach that is respectful of an individual's health priorities. Informed decision-making is essential to person-centered care, especially as patients age. In a feasibility study, we evaluated the effects of a new decision aid (Decide2Rest) on OSA treatment decision-making in older adults.
METHODS


Patients (aged ≥ 60 years) with newly diagnosed OSA were recruited from two healthcare systems and randomized to either Decide2Rest or a control program. Post-intervention outcomes included 1) Decisional Conflict Scale (DCS; 0-100 where 0=low and 100=high conflict), which measures perceptions of uncertainty, whether decisions reflect what matters most to patients and whether patients feel supported in decision making, 2) Preparation for Decision Making scale (PDM; 0-100 where 0=least and 100 most prepared), and OSA knowledge (0-100 where 0=poor and 100 outstanding). Multivariable linear regression models examined relationships between Decide2Rest and outcomes (DCS, PDM, OSA knowledge).
RESULTS


73 patients were randomized to Decide2Rest (N=36; mean age 69 years; 72% male) versus control (N= 37; mean age 69 years; 70% male). Results from the regressions, controlling for study site, indicated that the Decide2Rest program resulted in less decisional conflict (20.5 versus 32.7 on the DCS; p=.014), more preparedness for decision-making (87.8 versus 66.2 on the PDM scale; p<.001), and greater OSA knowledge (75.1 versus 65.3 OSA knowledge score; p=.04) scores than the control group.
CONCLUSIONS


The Decide2Rest program promotes person-centered OSA decision-making for older patients with newly diagnosed OSA. Future studies are needed to optimize implementation of the program.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov, Title: Improving Older Adults' Decision Making for OSAT (eDecide2Rest), Identifier: NCT03138993, URL: https://clinicaltrials.gov/ct2/show/NCT03138993.",2020,"Results from the regressions, controlling for study site, indicated that the Decide2Rest program resulted in less decisional conflict (20.5 versus 32.7 on the DCS; p=.014), more preparedness for decision-making (87.8 versus 66.2 on the PDM scale; p<.001), and greater OSA knowledge (75.1 versus 65.3 OSA knowledge score; p=.04) scores than the control group.
","['older adults', '73 patients were randomized to Decide2Rest (N=36; mean age 69 years; 72% male) versus control (N= 37; mean age 69 years; 70% male', 'Person-centered obstructive sleep apnea (OSA) care', 'Patients (aged ≥ 60 years) with newly diagnosed OSA', 'older adults with obstructive sleep apnea', 'older patients with newly diagnosed OSA']","['new decision aid (Decide2Rest', 'Decide2Rest or a control program']","['Decide2Rest and outcomes (DCS, PDM, OSA knowledge', 'OSA knowledge', 'Decisional Conflict Scale', 'decisional conflict']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",73.0,0.0442605,"Results from the regressions, controlling for study site, indicated that the Decide2Rest program resulted in less decisional conflict (20.5 versus 32.7 on the DCS; p=.014), more preparedness for decision-making (87.8 versus 66.2 on the PDM scale; p<.001), and greater OSA knowledge (75.1 versus 65.3 OSA knowledge score; p=.04) scores than the control group.
","[{'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Fung', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Martin', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Li-Jung', 'Initials': 'LJ', 'LastName': 'Liang', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Ron D', 'Initials': 'RD', 'LastName': 'Hays', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Nananda', 'Initials': 'N', 'LastName': 'Col', 'Affiliation': 'University of New England, Biddeford, Maine.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Patterson', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Josephson', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Mitchell', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Sanchez', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Aysola', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Yeonsu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Dzierzewski', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Zeidler', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Alessi', 'Affiliation': 'Geriatric, Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8798']
2109,32955023,Positive tendency toward synchronous use of acetaminophen and ibuprofen in treating patients with patent ductus arteriosus.,"OBJECTIVE


Spontaneous closure of the ductus arteriosus often fails to occur in premature newborns and this condition can be associated with increased morbidity and mortality. The initial treatment to achieve closure of the opening is pharmacological, and various nonsteroidal anti-inflammatory drugs may be used. The aim of this study was to determine whether combining acetaminophen with ibuprofen is more effective than the individual use of these drugs to treat patent ductus arteriosus (PDA).
METHODS


The present randomized, controlled trial study included 154 premature newborns with PDA. The patients were randomized into 3 groups: the acetaminophen group (n=67), ibuprofen group (n=68), and combination drug group (n=19). Echocardiography was performed before initiating the medication and after completing a first and second course of treatment. Blood markers were measured to assess the safety of the 3 types of therapy.
RESULTS


After the first course of treatment, PDA closure was seen in 76.1% of the infants in the acetaminophen group, 76.4% of those in the ibuprofen group, and 78.9% of the combination therapy group (p=0.97). The closure rate after a second course of treatment was 43.7% in the acetaminophen group, 62.5% in the ibuprofen group, and 100% in the combination group. There were no complications attributed to the 3 methods of treatment used.
CONCLUSION


Concomitant use of acetaminophen and ibuprofen can be an effective option for closure of PDA. Other studies with a larger sample size are recommended in order to confirm these results.",2020,"There were no complications attributed to the 3 methods of treatment used.
","['154 premature newborns with PDA', 'patent ductus arteriosus (PDA', 'patients with patent ductus arteriosus', 'premature newborns']","['acetaminophen', 'acetaminophen with ibuprofen', 'acetaminophen and ibuprofen', 'ibuprofen']","['PDA closure', 'morbidity and mortality', 'closure rate', 'Blood markers']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",154.0,0.0244522,"There were no complications attributed to the 3 methods of treatment used.
","[{'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Oboodi', 'Affiliation': 'Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Khadijeh Sadat', 'Initials': 'KS', 'LastName': 'Najib', 'Affiliation': 'Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Amoozgar', 'Affiliation': 'Department of Pediatric Cardiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Pourarian', 'Affiliation': 'Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Moghtaderi', 'Affiliation': 'Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Mehdizadegan', 'Affiliation': 'Department of Pediatric Cardiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Sabzevari', 'Affiliation': 'Neonatal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Turk Kardiyoloji Dernegi arsivi : Turk Kardiyoloji Derneginin yayin organidir,['10.5543/tkda.2020.03902']
2110,32955081,"Treatment of COVID-19 Patients with Prolonged Post-Symptomatic Viral Shedding with Leflunomide -- a Single-Center, Randomized, Controlled Clinical Trial.","OBJECTIVE


To evaluate the efficacy and safety of leflunomide, an approved dihydroorotate dehydrogenase inhibitor, to treat COVID-19 patients with prolonged post-symptomatic viral shedding.
METHODS


We conducted a prospective, randomized, controlled, open-label trial involving hospitalized adult COVID-19 patients with prolonged PCR positivity. Patients were randomly assigned to receive either leflunomide (50 mg, q12h, three consecutive times, orally; then 20 mg, once daily for 8 days), in addition to nebulized interferon alpha 2a (IFN α-2a, 3 million IU each time, twice daily for 10 days), or nebulized IFN α-2a alone for 10 days. The primary end point was the duration of viral shedding.
RESULTS


A total of 50 COVID-19 patients with prolonged PCR positivity were randomized into 2 groups; 26 were assigned to the leflunomide group, and 24 were assigned to the interferon alone group. Treatment with leflunomide was not associated with a difference from the interferon alone group in the duration of viral shedding (hazard ratio for negative RT-PCR, 0.70; 95% confidence interval, 0.391-1.256; P=0.186). In addition, the patients given leflunomide did not have a substantially shorter length of hospital stay than patients treated with interferon alone, with median (IQRs) durations of 29.0 (19.3-47.3) days and 33.0 (29.3-42.8) days, respectively, P=0.170. Two leflunomide recipients were unable to complete the full 10-day course of administration due to adverse events.
CONCLUSIONS


In COVID-19 patients with prolonged PCR positivity, no benefit in terms of the duration of viral shedding was observed with the combined treatment of leflunomide and IFN α-2a beyond IFN α-2a alone.",2020,"Treatment with leflunomide was not associated with a difference from the interferon alone group in the duration of viral shedding (hazard ratio for negative RT-PCR, 0.70; 95% confidence interval, 0.391-1.256; P=0.186).","['50 COVID-19 patients with prolonged PCR positivity', 'hospitalized adult COVID-19 patients with prolonged PCR positivity', 'COVID-19 patients with prolonged post-symptomatic viral shedding', 'COVID-19 Patients with Prolonged Post-Symptomatic Viral Shedding with Leflunomide -- a Single-Center']","['interferon', 'interferon alone', 'nebulized IFN α-2a alone', 'leflunomide']","['shorter length of hospital stay', 'duration of viral shedding']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0063041', 'cui_str': 'leflunomide'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}]",50.0,0.207998,"Treatment with leflunomide was not associated with a difference from the interferon alone group in the duration of viral shedding (hazard ratio for negative RT-PCR, 0.70; 95% confidence interval, 0.391-1.256; P=0.186).","[{'ForeName': 'Mengmei', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Zhishui', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Xiaochen', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Shaolin', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}, {'ForeName': 'Zhenlian', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'East Campus, Renmin Hospital of Wuhan University, Donghu High-tech District, Wuhan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'East Campus, Renmin Hospital of Wuhan University, Donghu High-tech District, Wuhan, China.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Wan', 'Affiliation': 'East Campus, Renmin Hospital of Wuhan University, Donghu High-tech District, Wuhan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong, Wuhan, China.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1417']
2111,32955088,"Rezafungin versus Caspofungin in a Phase 2, Randomized, Double-Blind Study for the Treatment of Candidemia and Invasive Candidiasis- The STRIVE Trial.","BACKGROUND


Rezafungin (RZF) is a novel echinocandin exhibiting distinctive pharmacokinetics/pharmacodynamics. STRIVE was a phase 2, double-blind, randomized trial designed to compare the safety and efficacy of RZF once weekly (QWk) to caspofungin (CAS) once daily for treatment of candidemia and/or invasive candidiasis (IC).
METHODS


Adults with systemic signs and mycological confirmation of candidemia and/or IC were randomized to RZF 400 mg QWk (400 mg), RZF 400 mg on week 1 then 200 mg QWk (400/200 mg), or CAS 70 mg as a loading dose followed by 50 mg daily for ≤ 4 weeks. Efficacy assessments included overall cure (resolution of signs of candidemia/IC + mycological eradication) at day 14 (primary endpoint), investigator-assessed clinical response at day 14, and 30-day all-cause mortality (ACM) (secondary endpoints), and time to negative blood culture. Safety was evaluated by adverse events and ACM through follow-up.
RESULTS


Of 207 patients enrolled, 183 were in the microbiological intent-to-treat population (~21% IC). Overall cure rates were 60.5% (46/76) for RZF 400 mg, 76.1% (35/46) for RZF 400/200 mg, and 67.2% (41/61) for CAS; investigator-assessed clinical cure rates were 69.7% (53/76), 80.4% (37/46), and 70.5% (43/61), respectively. 30-day ACM was 15.8% for RZF 400 mg, 4.4% for RZF 400/200 mg, and 13.1% for CAS. Candidemia was cleared in 19.5 and 22.8 hours in RZF and CAS patients, respectively. No concerning safety trends were observed; ACM through follow-up was 15.2% (21/138) for RZF and 18.8% (13/69) for CAS.
CONCLUSIONS


RZF was safe and efficacious in the treatment of candidemia and/or IC.",2020,"Overall cure rates were 60.5% (46/76) for RZF 400 mg, 76.1% (35/46) for RZF 400/200 mg, and 67.2% (41/61) for CAS; investigator-assessed clinical cure rates were 69.7% (53/76), 80.4% (37/46), and 70.5% (43/61), respectively.","['candidemia and/or invasive candidiasis (IC', 'Candidemia and Invasive Candidiasis', '207 patients enrolled, 183 were in the microbiological intent-to-treat population (~21% IC', 'Adults with systemic signs and mycological confirmation of candidemia and/or IC']","['RZF 400\xa0mg QWk', 'Rezafungin (RZF', 'Rezafungin versus Caspofungin', 'RZF', 'RZF once weekly (QWk) to caspofungin (CAS', 'CAS 70\xa0mg as a loading dose followed by 50\xa0mg daily for ≤ 4 weeks', 'RZF 400\xa0mg on week 1 then 200\xa0mg QWk']","['Candidemia', 'clinical cure rates', 'safety and efficacy', '30-day ACM', 'investigator-assessed clinical response at day 14, and 30-day all-cause mortality (ACM) (secondary endpoints), and time to negative blood culture', 'Overall cure rates', 'overall cure (resolution of signs of candidemia/IC + mycological eradication']","[{'cui': 'C0877445', 'cui_str': 'Candidemia'}, {'cui': 'C0153252', 'cui_str': 'Invasive candidiasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}]","[{'cui': 'C4726687', 'cui_str': 'Rezafungin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0537894', 'cui_str': 'Caspofungin'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0877445', 'cui_str': 'Candidemia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0852859', 'cui_str': 'Blood culture negative'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0153252', 'cui_str': 'Invasive candidiasis'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}]",207.0,0.36066,"Overall cure rates were 60.5% (46/76) for RZF 400 mg, 76.1% (35/46) for RZF 400/200 mg, and 67.2% (41/61) for CAS; investigator-assessed clinical cure rates were 69.7% (53/76), 80.4% (37/46), and 70.5% (43/61), respectively.","[{'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Thompson', 'Affiliation': 'Dept. of Internal Medicine Division of Infectious Diseases, and Dept. of Medical Microbiology and Immunology University of California Davis Medical Center, Sacramento, California, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Soriano', 'Affiliation': 'Dept of Infectious Diseases, Hospital Clínic de Barcelona, IDIBAPS, University of Barcelona, Spain.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Skoutelis', 'Affiliation': 'Dept of Medicine and Infectious Diseases, Evangelismos General Hospital, Athens, Greece.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Vazquez', 'Affiliation': 'Dept of Medicine/Division of Infectious Disease, Medical College of Georgia/Augusta University, Augusta, Georgia, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Honore', 'Affiliation': 'Dept of Intensive Care, Brugmann University Hospital, Brussels, Belgium.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Horcajada', 'Affiliation': ""Dept of Infectious Diseases, Hospital del Mar, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM). Universitat Autònoma de Barcelona (UAB), Universitat Pompeu Fabra (UPF), Barcelona, Spain.""}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Spapen', 'Affiliation': 'Dept of Intensive Care, University Hospital Brussels, Brussels, Belgium.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bassetti', 'Affiliation': 'Dept of Health Sciences University of Genoa and Policlinico San Martino IST, Genoa, Italy.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ostrosky-Zeichner', 'Affiliation': 'Division of Infectious Diseases, McGovern Medical School, Houston, Texas, USA.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'AD Stat Consulting, Guerneville, California, USA.'}, {'ForeName': 'Rolando M', 'Initials': 'RM', 'LastName': 'Viani', 'Affiliation': 'Cidara Therapeutics, San Diego, California, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Sandison', 'Affiliation': 'Cidara Therapeutics, San Diego, California, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Pappas', 'Affiliation': 'Dept of Internal Medicine Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1380']
2112,32955108,Author response to: Comment on: Short-term outcomes of a multicentre randomized clinical trial comparing D2 versus D3 lymph node dissection for colonic cancer (COLD trial).,,2020,,[],['D2 versus D3 lymph node dissection'],[],[],"[{'cui': 'C2960226', 'cui_str': 'D3 lymph node dissection'}]",[],,0.136922,,"[{'ForeName': 'Aleksei', 'Initials': 'A', 'LastName': 'Petrov', 'Affiliation': ''}]",The British journal of surgery,['10.1002/bjs.11930']
2113,32955117,Comment on: Short-term outcomes of a multicentre randomized clinical trial comparing D2 versus D3 lymph node dissection for colonic cancer (COLD trial).,,2020,,[],['D2 versus D3 lymph node dissection'],[],[],"[{'cui': 'C2960226', 'cui_str': 'D3 lymph node dissection'}]",[],,0.165545,,"[{'ForeName': 'Hena', 'Initials': 'H', 'LastName': 'Hidayat', 'Affiliation': 'Colorectal Department, University Hospital Of North Tees.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Etherson', 'Affiliation': 'Colorectal Department, University Hospital Of North Tees.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Shanmugam', 'Affiliation': 'Colorectal Department, University Hospital Of North Tees.'}]",The British journal of surgery,['10.1002/bjs.11931']
2114,32955118,Comment on: Effect of an individualized versus standard pneumoperitoneum pressure strategy on postoperative recovery: a randomized clinical trial in laparoscopic colorectal surgery.,,2020,,[],"['individualized versus standard pneumoperitoneum pressure strategy', 'laparoscopic colorectal surgery']",['postoperative recovery'],[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.0921164,,"[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of general surgery, Tongde\u2009Hospital\u2009of\u2009Zhejiang\u2009Province, 234 Gucui RD, Hangzhou, 310012, China.'}, {'ForeName': 'Yuanshui', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of general surgery, Tongde\u2009Hospital\u2009of\u2009Zhejiang\u2009Province, 234 Gucui RD, Hangzhou, 310012, China.'}]",The British journal of surgery,['10.1002/bjs.11933']
2115,32955159,Novel methodology for measuring intraoral wear in enamel and dental restorative materials.,"OBJECTIVES


To test the hypotheses that (a) the chairside/handheld dental scanner combined with a metrology software will measure clinical wear in vivo in agreement with measurements from X-ray computed microtomography and; (b) polished monolithic zirconia does not cause accelerated wear of opposing enamel.
MATERIALS AND METHODS


Thirty single crowns were randomized to receive a monolithic zirconia or metal-ceramic crown. Two non-restored opposing teeth in the same quadrants were identified to serve as enamel controls. After cementation, quadrants were scanned using an intraoral dental scanner. Patients were recalled at 6-months and 1-year for re-scanning. Scanned images were compared using a metrology software to determine maximum vertical wear of teeth. The accuracy of the scanning measurements from this new method was compared with X-ray computed microtomography (micro-CT) measurements. Statistical analysis was performed using Mann-Whitney U test to determine significant differences between wear of enamel against zirconia, metal-ceramic or enamel. Linear regression analysis determined agreement between measurements obtained using intraoral scanning and micro-CT.
RESULTS


Regression analysis demonstrated that there is a quantitative agreement between depth and volume measurements produced using intraoral scanning and the micro-CT methodologies. There was no significant difference between the wear of enamel against polished monolithic zirconia crowns and enamel against enamel.
CONCLUSIONS


Intraoral scanning combined with a matching software can accurately quantify clinical wear to verify that monolithic zirconia exhibited comparable wear of enamel compared with metal-ceramic crowns and control enamel. Agreement between the intraoral scanner and the micro-CT was 99.8%. Clinical Trials.gov NCT02289781.",2020,"There was no significant difference between the wear of enamel against polished monolithic zirconia crowns and enamel against enamel.
","['Thirty single crowns', 'intraoral wear in enamel and dental restorative materials']",['monolithic zirconia or metal-ceramic crown'],['wear of enamel against polished monolithic zirconia crowns and enamel against enamel'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0440171', 'cui_str': 'Dental ceramic crown material'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]",30.0,0.054977,"There was no significant difference between the wear of enamel against polished monolithic zirconia crowns and enamel against enamel.
","[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'F Esquivel-Upshaw', 'Affiliation': 'Restorative Dental Sciences, Division of Prosthodontics, University of Florida College of Dentistry, Gainesville, Florida, USA.'}, {'ForeName': 'Shu-Min', 'Initials': 'SM', 'LastName': 'Hsu', 'Affiliation': 'Restorative Dental Sciences, Division of Prosthodontics, University of Florida College of Dentistry, Gainesville, Florida, USA.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Bohórquez', 'Affiliation': ""Herbert Wertheim College of Engineering's Research Service Centers, University of Florida College of Engineering, Gainesville, Florida, USA.""}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Abdulhameed', 'Affiliation': 'Restorative Dentistry, LECOM School of Dental Medicine Bradenton, Florida, USA.'}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Scheiffele', 'Affiliation': ""Herbert Wertheim College of Engineering's Research Service Centers, University of Florida College of Engineering, Gainesville, Florida, USA.""}, {'ForeName': 'Mijin', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Restorative Dental Sciences, Division of Prosthodontics, University of Florida College of Dentistry, Gainesville, Florida, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Neal', 'Affiliation': 'Department of Neurosurgery, University of Florida College of Medicine, Gainesville, Florida, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chai', 'Affiliation': 'Department of Prosthodontics, Northwestern University Dental School, Chicago, Illinois, USA.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Ren', 'Affiliation': 'Department of Chemical Engineering, University of Florida Herbert Wertheim College of Engineering, Gainesville, Florida, USA.'}]",Clinical and experimental dental research,['10.1002/cre2.322']
2116,32955164,Hematological adaptations and detection of recombinant human erythropoietin combined with chronic hypoxia.,"This study evaluated whether recombinant human erythropoietin (rhEpo) treatment combined with chronic hypoxia provided an additive erythropoietic response and whether the Athlete Biological Passport (ABP) sensitivity improved with hypoxia. Two interventions were completed, each containing four weeks baseline, four weeks exposure at sea-level or 2,320m of altitude and four weeks follow-up. Participants were randomly assigned to 20 IU·kg bw -1  rhEpo or placebo injections every second day for three weeks during the exposure period at sea-level (rhEpo n=25, placebo n=9) or at altitude (rhEpo n=12, placebo n=27). Venous blood was analyzed weekly. Combining rhEpo and hypoxia induced larger changes compared with rhEpo or hypoxia alone for [Hb] (P<0.001, P>0.05, respectively), reticulocyte percentage (P<0.001) and OFF-hr score (P<0.01, P<0.001, respectively). The most pronounced effect was observed for reticulocyte percentage with up to ~35% (P<0.001) and ~45% (P<0.001) higher levels compared with rhEpo or hypoxia only, respectively. The ABP sensitivity for the combined treatment was 54 and 35 percentage points higher for [Hb] (P<0.05) and reticulocyte percentage (P<0.05), respectively, but similar for OFF-hr score, compared with rhEpo at sea-level. Across any time point, [Hb] and OFF-hr score combined identified 14 unique true-positive participants (56%) at sea-level and 12 unique true-positive participants (100%) at altitude. However, a concurrent reduction in specificity existed at altitude. In conclusion, rhEpo treatment combined with hypoxic exposure provided an additive erythropoietic response compared to rhEpo or hypoxic exposure alone. Correspondingly, ABP was more sensitive to rhEpo at altitude than at sea-level, but a compromised specificity existed with hypoxic exposure.",2020,"The ABP sensitivity for the combined treatment was 54 and 35 percentage points higher for [Hb] (P<0.05) and reticulocyte percentage (P<0.05), respectively, but similar for OFF-hr score, compared with rhEpo at sea-level.",[],"['recombinant human erythropoietin (rhEpo', 'recombinant human erythropoietin combined with chronic hypoxia', '20 IU·kg bw -1  rhEpo or placebo injections every second day for three weeks during the exposure period at sea-level (rhEpo n=25, placebo n=9) or at altitude (rhEpo n=12, placebo']","['reticulocyte percentage (P<0.001) and OFF-hr score', 'Venous blood', 'Athlete Biological Passport (ABP) sensitivity', 'ABP sensitivity', 'reticulocyte percentage', 'additive erythropoietic response']",[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0585312', 'cui_str': 'Every second'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}]","[{'cui': 'C1167975', 'cui_str': 'Reticulocyte percentage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0442796', 'cui_str': 'Additive'}]",,0.101148,"The ABP sensitivity for the combined treatment was 54 and 35 percentage points higher for [Hb] (P<0.05) and reticulocyte percentage (P<0.05), respectively, but similar for OFF-hr score, compared with rhEpo at sea-level.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bejder', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Denmark.'}, {'ForeName': 'Andreas Breenfeldt', 'Initials': 'AB', 'LastName': 'Andersen', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas Christian', 'Initials': 'TC', 'LastName': 'Bonne', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Linkis', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Denmark.'}, {'ForeName': 'Niels Vidiendal', 'Initials': 'NV', 'LastName': 'Olsen', 'Affiliation': 'Department of Neuroscience and Pharmacology, University of Copenhagen, Denmark.'}, {'ForeName': 'Jesús Rodríguez', 'Initials': 'JR', 'LastName': 'Huertas', 'Affiliation': 'Department of Physiology, Faculty of Sport Sciences, Institute of Nutrition and Food Technology, Biomedical Research Centre, University of Granada, Armilla, Spain.'}, {'ForeName': 'Nikolai Baastrup', 'Initials': 'NB', 'LastName': 'Nordsborg', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Denmark.'}]",Drug testing and analysis,['10.1002/dta.2931']
2117,32955174,Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer.,"BACKGROUND


We previously reported that olaparib led to significantly longer imaging-based progression-free survival than the physician's choice of enzalutamide or abiraterone among men with metastatic castration-resistant prostate cancer who had qualifying alterations in homologous recombination repair genes and whose disease had progressed during previous treatment with a next-generation hormonal agent. The results of the final analysis of overall survival have not yet been reported.
METHODS


In an open-label, phase 3 trial, we randomly assigned patients in a 2:1 ratio to receive olaparib (256 patients) or the physician's choice of enzalutamide or abiraterone plus prednisone as the control therapy (131 patients). Cohort A included 245 patients with at least one alteration in  BRCA1 ,  BRCA2 , or  ATM , and cohort B included 142 patients with at least one alteration in any of the other 12 prespecified genes. Crossover to olaparib was allowed after imaging-based disease progression for patients who met certain criteria. Overall survival in cohort A, a key secondary end point, was analyzed with the use of an alpha-controlled, stratified log-rank test at a data maturity of approximately 60%. The primary and other key secondary end points were reported previously.
RESULTS


The median duration of overall survival in cohort A was 19.1 months with olaparib and 14.7 months with control therapy (hazard ratio for death, 0.69; 95% confidence interval [CI], 0.50 to 0.97; P = 0.02). In cohort B, the median duration of overall survival was 14.1 months with olaparib and 11.5 months with control therapy. In the overall population (cohorts A and B), the corresponding durations were 17.3 months and 14.0 months. Overall, 86 of 131 patients (66%) in the control group crossed over to receive olaparib (56 of 83 patients [67%] in cohort A). A sensitivity analysis that adjusted for crossover to olaparib showed hazard ratios for death of 0.42 (95% CI, 0.19 to 0.91) in cohort A, 0.83 (95% CI, 0.11 to 5.98) in cohort B, and 0.55 (95% CI, 0.29 to 1.06) in the overall population.
CONCLUSIONS


Among men with metastatic castration-resistant prostate cancer who had tumors with at least one alteration in  BRCA1 ,  BRCA2 , or  ATM  and whose disease had progressed during previous treatment with a next-generation hormonal agent, those who were initially assigned to receive olaparib had a significantly longer duration of overall survival than those who were assigned to receive enzalutamide or abiraterone plus prednisone as the control therapy, despite substantial crossover from control therapy to olaparib. (Funded by AstraZeneca and Merck Sharp & Dohme; PROfound ClinicalTrials.gov number, NCT02987543.).",2020,"A sensitivity analysis that adjusted for crossover to olaparib showed hazard ratios for death of 0.42 (95% CI, 0.19 to 0.91) in cohort A, 0.83 (95% CI, 0.11 to 5.98) in cohort B, and 0.55 (95% CI, 0.29 to 1.06) in the overall population.
","['men with metastatic castration-resistant prostate cancer who had qualifying alterations in homologous recombination repair genes and whose disease had progressed during previous treatment with a next-generation hormonal agent', 'patients who met certain criteria', '245 patients with at least one alteration in  BRCA1 ,  BRCA2 , or  ATM , and cohort B included 142 patients with at least one alteration in any of the other 12 prespecified genes', ""256 patients) or the physician's choice of"", 'men with metastatic castration-resistant prostate cancer who had tumors with at least one alteration in  BRCA1 ,  BRCA2 , or  ATM  and whose disease had progressed during previous treatment with a next-generation hormonal agent, those who were initially assigned to receive', 'Metastatic Castration-Resistant Prostate Cancer']","['enzalutamide or abiraterone plus prednisone', 'olaparib', 'enzalutamide or abiraterone']","['hazard ratios for death', 'Overall survival', 'longer duration of overall survival', 'Survival', 'median duration of overall survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}, {'cui': 'C0103097', 'cui_str': 'ammonium tetrathiomolybdate'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",245.0,0.341761,"A sensitivity analysis that adjusted for crossover to olaparib showed hazard ratios for death of 0.42 (95% CI, 0.19 to 0.91) in cohort A, 0.83 (95% CI, 0.11 to 5.98) in cohort B, and 0.55 (95% CI, 0.29 to 1.06) in the overall population.
","[{'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Mateo', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Przemyslaw', 'Initials': 'P', 'LastName': 'Twardowski', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Guilhem', 'Initials': 'G', 'LastName': 'Roubaud', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Burgents', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gresty', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Corcoran', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Adelman', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': ""From the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona (J.M.), the Spanish National Cancer Research Center, Madrid (D.O.), and Instituto de Investigación Biomédica de Málaga, Málaga (D.O.) - all in Spain; Institut Gustave Roussy, University of Paris Saclay, Villejuif (K.F.), the Department of Medical Oncology, Centre Hospitalier Universitaire Besançon, Besançon (A.T.-V.), and the Department of Medical Oncology, Institut Bergonié, Bordeaux (G.R.) - all in France; Centre Hospitalier de l'Université de Montréal-Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal (F.S.), and BC Cancer Agency, Vancouver (K.N.C.) - both in Canada; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (S.S.); Tulane University School of Medicine, New Orleans (O.S.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); John Wayne Cancer Institute, Santa Monica, CA (P.T.); Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey (M.O.); AstraZeneca, Global Medicines Development, Oncology, Gaithersburg, MD (J.K.); Merck, Kenilworth, NJ (J.B.); and Global Medicines Development, Oncology (C.G.), Precision Medicine and Biosamples, R&D Oncology (C.C.), and Translational Medicine (C.A.A.), AstraZeneca, Cambridge, and the Institute of Cancer Research and Royal Marsden, London (J.B.) - both in the United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2022485']
2118,32927269,The effect of remote patient monitoring on the primary care clinic visit frequency among adults with type 2 diabetes.,"AIMS


Healthcare organizations are increasingly using technology to assist in diabetes management based on telemedicine's proven ability to improve glycemic regulation, decrease cost, and overcome barriers to effective healthcare. Nevertheless, it remains unclear how telemedicine intersects with primary care. We aim to measure the impact of a remote monitoring program for diabetes on primary care delivery through analysis of primary care office visit frequency.
METHODS


Patients eligible to participate in our institution's remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care""). The number of scheduled and completed primary care office visits in the 12 months prior to and after the index date were measured for both groups. The index date was the enrollment date or, for the patients who received usual care, the next available enrollment session after eligibility screen. Two-sample t-tests were used to examine the change in frequency of office visits prior to and after enrollment for participants, as well as the difference in visit frequency between enrolled patients versus patients receiving usual care.
RESULTS


There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth. Furthermore, there was no difference in the number of scheduled or completed primary care visits between patients enrolled in telehealth versus those receiving usual care.
CONCLUSION


Participation in telehealth has been shown to be associated with significant HbA1c reductions in prior work, yet our data suggest that remote monitoring is not associated with a change in primary care office visit frequency. This suggests that telehealth may improve diabetes management independently of primary care visits.",2020,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"['adults with type 2 diabetes', 'Patients eligible to participate in our institution\'s remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care']","['remote monitoring program', 'remote patient monitoring']",['number of scheduled or completed primary care clinic visits'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0422587', 'cui_str': 'Diabetes monitoring check done'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]",,0.0160126,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"[{'ForeName': 'Morgan Hampton', 'Initials': 'MH', 'LastName': 'Randall', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Zachary Merle', 'Initials': 'ZM', 'LastName': 'Haulsee', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'William Patrick', 'Initials': 'WP', 'LastName': 'Moran', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth Barnhardt', 'Initials': 'EB', 'LastName': 'Kirkland', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kirklane@musc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104267']
2119,32927285,"Open-label titration of apomorphine sublingual film in patients with Parkinson's disease and ""OFF"" episodes.","INTRODUCTION


The efficacy and safety of apomorphine sublingual film (APL-130277; APL) for the on-demand treatment of ""OFF"" episodes associated with Parkinson's disease (PD) was demonstrated in a double-blind trial. Herein we describe the ability of patients to receive effective and tolerable APL dose titration during the open-label titration phase.
METHODS


Adult patients with levodopa-responsive PD and ""OFF"" episodes were enrolled. In practically defined ""OFF,"" patients were observed for a FULL ""ON"" after their usual morning carbidopa/levodopa (CD/LD) dose and then after titration with APL following each increasing dose (10-35 mg). Antiemetic medication was administered for 3 days before initiation of titration and was continued throughout titration. Motor responses were evaluated predose and postdose using Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. Safety outcomes were evaluated.
RESULTS


Among 141 patients who enrolled in the study and received APL during open-label titration, 109 (77.3%) achieved a FULL ""ON"" (66.1% at 10-20 mg) and 10 did not. Patients who successfully completed APL dose titration tended to be younger, had a longer mean time since PD diagnosis, and had lower levodopa requirements than those who discontinued during titration for any reason. Change in MDS-UPDRS Part III scores from predose to 30 min postdose after titration with the effective dose of APL (n = 109) was similar across all dose groups. In a post hoc analysis, the magnitude of motor response with APL was ~2-fold higher than with CD/LD 15 min postdose, and the observed peak response occurred earlier with APL than with the trend seen for CD/LD (45 vs 90 min, respectively). Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%). Twelve patients discontinued due to TEAEs during APL dose titration, most commonly (≥2%) because of dizziness (2.8%), nausea (2.1%), and somnolence (2.1%).
CONCLUSION


Among eligible patients with PD and ""OFF"" episodes who had their APL dose successfully titrated to an effective and tolerable level, most were able to do so within the first 3 titrated doses but some required further dose escalations. The use of APL can provide benefit for the treatment of ""OFF"" episodes.",2020,"Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%).","['patients with Parkinson\'s disease and ""OFF"" episodes', '141 patients who enrolled in the study and received', 'OFF"" episodes associated with Parkinson\'s disease (PD', 'eligible patients with PD and ""OFF"" episodes who had their', 'Adult patients with levodopa-responsive PD and ""OFF"" episodes were enrolled']","['apomorphine sublingual film', 'APL', 'apomorphine sublingual film (APL-130277; APL', 'FULL ""ON']","['peak response', ""predose and postdose using Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS"", 'Change in MDS-UPDRS Part III scores', 'nausea', 'magnitude of motor response with APL', 'longer mean time since PD diagnosis', 'somnolence', 'dizziness', 'levodopa requirements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}]","[{'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0023487', 'cui_str': 'Acute promyelocytic leukemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}]",141.0,0.03312,"Overall, the most common (≥10%) treatment-emergent adverse events (TEAEs) during APL dose titration were nausea (20.6%), yawning (12.1%), dizziness (11.3%), and somnolence (11.3%).","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Hui', 'Affiliation': 'Keck School of Medicine of USC, University of Southern California, Los Angeles, CA, United States. Electronic address: Jennifer.hui@med.usc.edu.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Fox', 'Affiliation': 'University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada; Division of Neurology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Neeson', 'Affiliation': 'Sunovion Pharmaceuticals Canada Inc., Mississauga, Ontario, Canada.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Bhargava', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pappert', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Navia', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.08.028']
2120,32927324,Enhanced Recovery after Surgery in Elderly Gastric Cancer Patients Undergoing Laparoscopic Total Gastrectomy.,"BACKGROUND


The aim of this study was to evaluate the effects of the enhanced recovery after surgery (ERAS) program versus conventional perioperative care on the short-term postoperative outcomes among elderly patients with gastric cancer who are undergoing laparoscopic total gastrectomy.
METHODS


Elderly patients with gastric cancer (age ≥ 65 y) who are undergoing laparoscopic total gastrectomy were randomized to ERAS or conventional perioperative care groups. Short-term postoperative outcomes, including postoperative hospital stay, mortality, complications, readmission rate, and reoperation rate were compared between the two groups. In addition, blood samples were taken preoperatively (baseline) and on postoperative days 1, 3, and 5. Systemic human leukocyte antigen (HLA)-DR expression on monocytes and C-reactive protein (CRP) were analyzed.
RESULTS


Of the 171 eligible patients, 85 patients were assigned to receive ERAS program treatment (ERAS group) and 86 patients to receive conventional care (conventional group). The patients' characteristics were comparable. Postoperative hospital stay was shorter in the ERAS group than in the conventional group (11 [7-11] versus 13 [8-20] d, P < 0.001). Hospital mortality, overall morbidity, morbidity ≥ Clavien-Dindo (C-D) grade II, readmission rate, and reoperation rate did not show significant differences between the two groups. However, morbidity ≥ C-D grade IIIa was lower in the ERAS group than that in the conventional group (8.2% versus 18.6%, P = 0.047). The ERAS program shortened the number of days to postoperative first flatus, first defecation, semifluid diet, and soft bland diet. Moreover, the ERAS program increased the HLA-DR expression on monocytes and decreased the CRP levels on postoperative days 1, 3, and 5.
CONCLUSIONS


The ERAS program was feasible and effective for elderly patients with gastric cancer who are undergoing laparoscopic total gastrectomy. The benefits of ERAS were associated with improvement of impaired immune function and suppression of inflammatory reaction.",2020,"Moreover, the ERAS program increased the HLA-DR expression on monocytes and decreased the CRP levels on postoperative days 1, 3, and 5.
","['171 eligible patients, 85 patients', '65 y) who are undergoing laparoscopic total gastrectomy', 'Elderly Gastric Cancer Patients Undergoing Laparoscopic Total Gastrectomy', 'Elderly patients with gastric cancer (age\xa0≥', 'elderly patients with gastric cancer who are undergoing laparoscopic total gastrectomy']","['ERAS', 'Systemic human leukocyte antigen ', 'ERAS program', 'surgery (ERAS) program versus conventional perioperative care', 'ERAS program treatment (ERAS', 'conventional care (conventional group']","['CRP levels', 'impaired immune function and suppression of inflammatory reaction', 'HLA-DR expression on monocytes', 'HLA)-DR expression on monocytes and C-reactive protein (CRP', 'Postoperative hospital stay', 'postoperative hospital stay, mortality, complications, readmission rate, and reoperation rate', 'Hospital mortality, overall morbidity, morbidity\xa0≥\xa0Clavien-Dindo (C-D) grade II, readmission rate, and reoperation rate', 'number of days to postoperative first flatus, first defecation, semifluid diet, and soft bland diet', 'morbidity\xa0≥\xa0C-D grade IIIa']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR antigen'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0301572', 'cui_str': 'Bland diet'}]",171.0,0.022227,"Moreover, the ERAS program increased the HLA-DR expression on monocytes and decreased the CRP levels on postoperative days 1, 3, and 5.
","[{'ForeName': 'Shougen', 'Initials': 'S', 'LastName': 'Cao', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Taohua', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': 'Liver Disease Center, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of General Surgery, Dongying People's Hospital, Shandong, China.""}, {'ForeName': 'Zhaojian', 'Initials': 'Z', 'LastName': 'Niu', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Yanbing', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Shandong, China. Electronic address: yanbingzhou999@hotmail.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.07.037']
2121,32927371,Neural affective mechanisms associated with treatment responsiveness in veterans with PTSD and comorbid alcohol use disorder.,"Post-traumatic stress disorder (PTSD) is associated with neuro-physiological abnormalities reflecting increased anticipatory anxiety and reactivity to traumatic cues. It remains unclear whether neural mechanisms associated with PTSD treatment responsiveness, i.e. hyperactivation of the affective salience network in the brain, extend to a comorbid PTSD and substance use disorder population. Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD) were randomly assigned to either prolonged exposure or a non-exposure based treatment. They completed an affective anticipation task while undergoing fMRI, immediately prior and after completing treatment. After controlling for type and length of treatment, larger reduction of PTSD symptoms was associated with decreased anticipatory activation to negative trauma-related cues in the right pre-Supplementary Motor Area (pre-SMA), a region associated with emotion regulation. Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region. Our findings suggest that post-treatment reductions in anticipatory reactivity to trauma-related cues in the pre-SMA and para-hippocampal area are associated with larger PTSD symptom reduction in individuals with co-occurring PTSD and AUD. These results may offer neurofeedback training targets as an alternative to or enhancement of other PTSD treatment modalities in this population.",2020,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","['veterans with PTSD and comorbid alcohol use disorder', 'Thirty-one Veterans with PTSD and co-occurring alcohol use disorder (AUD', 'Post-traumatic stress disorder (PTSD']",['prolonged exposure or a non-exposure based treatment'],"['PTSD symptoms', 'PTSD severity']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",31.0,0.00943451,"Smaller reduction in PTSD severity was associated with enhanced anticipatory activation to those cues within the right para-hippocampal region, an affective processing region.","[{'ForeName': 'Katia M', 'Initials': 'KM', 'LastName': 'Harlé', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States. Electronic address: kharle@ucsd.edu.'}, {'ForeName': 'Alan N', 'Initials': 'AN', 'LastName': 'Simmons', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Andrea D', 'Initials': 'AD', 'LastName': 'Spadoni', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States; Department of Psychiatry, University of California San Diego, La Jolla, CA, United States.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111172']
2122,32931666,Hyperbaric oxygen therapy for COVID-19 patients with respiratory distress: treated cases versus propensity-matched controls.,"Objective


Given the high mortality and prolonged duration of mechanical ventilation of COVID-19 patients, we evaluated the safety and efficacy of hyperbaric oxygen for COVID-19 patients with respiratory distress.
Methods


This is a single-center clinical trial of COVID-19 patients at NYU Winthrop Hospital from March 31 to April 28, 2020. Patients in this trial received hyperbaric oxygen therapy at 2.0 atmospheres of pressure in monoplace hyperbaric chambers for 90 minutes daily for a maximum of five total treatments. Controls were identified using propensity score matching among COVID-19 patients admitted during the same time period. Using competing-risks survival regression, we analyzed our primary outcome of inpatient mortality and secondary outcome of mechanical ventilation.
Results


We treated 20 COVID-19 patients with hyperbaric oxygen. Ages ranged from 30 to 79 years with an oxygen requirement ranging from 2 to 15 liters on hospital days 0 to 14. Of these 20 patients, two (10%) were intubated and died, and none remain hospitalized. Among 60 propensity-matched controls based on age, sex, body mass index, coronary artery disease, troponin, D-dimer, hospital day, and oxygen requirement, 18 (30%) were intubated, 13 (22%) have died, and three (5%) remain hospitalized (with one still requiring mechanical ventilation). Assuming no further deaths among controls, we estimate that the adjusted subdistribution hazard ratios were 0.37 for inpatient mortality (p=0.14) and 0.26 for mechanical ventilation (p=0.046).
Conclusion


Though limited by its study design, our results demonstrate the safety of hyperbaric oxygen among COVID-19 patients and strongly suggests the need for a well-designed, multicenter randomized control trial.",2020,"Assuming no further deaths among controls, we estimate that the adjusted subdistribution hazard ratios were 0.37 for inpatient mortality (p=0.14) and 0.26 for mechanical ventilation (p=0.046).
","['60 propensity-matched controls based on age, sex, body mass index, coronary artery disease, troponin, D-dimer, hospital day, and oxygen requirement, 18 (30%) were intubated, 13 (22%) have died, and three (5%) remain hospitalized (with one still requiring mechanical ventilation', '20 COVID-19 patients with hyperbaric oxygen', 'COVID-19 patients with respiratory distress', 'COVID-19 patients at NYU Winthrop Hospital from March 31 to April 28, 2020', 'COVID-19 patients', 'Ages ranged from 30 to 79 years with an oxygen requirement ranging from 2 to 15 liters on hospital days 0 to 14']","['Hyperbaric oxygen therapy', 'hyperbaric oxygen therapy', 'hyperbaric oxygen']",['safety and efficacy'],"[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475211', 'cui_str': 'L'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0575499,"Assuming no further deaths among controls, we estimate that the adjusted subdistribution hazard ratios were 0.37 for inpatient mortality (p=0.14) and 0.26 for mechanical ventilation (p=0.046).
","[{'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Gorenstein', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Castellano', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Slone', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Gillette', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Alsamarraie', 'Affiliation': 'Division of Wound Care, Department of Surgery, NYU Winthrop Hospital, New York, NY, U.S.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Jacobson', 'Affiliation': 'NYU Long Island School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Wall', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Samrachana', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Population Health, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Jordan L', 'Initials': 'JL', 'LastName': 'Swartz', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Jenica J S', 'Initials': 'JJS', 'LastName': 'McMullen', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Osorio', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Koziatek', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, NYU Grossman School of Medicine, New York, NY, U.S.'}]","Undersea & hyperbaric medicine : journal of the Undersea and Hyperbaric Medical Society, Inc",[]
2123,32932393,Effect of Scleral Lens Oxygen Permeability on Corneal Physiology.,"SIGNIFICANCE


This randomized, masked, crossover clinical study identifies that ≥125 Dk materials should be used for scleral lens daily wear if disruption to corneal oxygen is to be minimized.
PURPOSE


Modern scleral lens use has increased and has proven to be successful where other types and materials have previously failed. Although the required oxygen permeability has been modeled, this has not been established clinically.
METHODS


Fifteen masked participants aged 20.7 ± 2.3 years (10 female) were bilaterally fitted with five different scleral lenses (65, 100, 125, 163, and 180+ Dk) of the same shape profile and one soft silicone hydrogel lens compared with no lens wear on separate occasions in a randomized order. A masked researcher measured corneal thickness and fluid reservoir depth, corneal curvature, objective bulbar and limbal redness, corneal biomechanics, and ocular surface oxygen consumption before and after 8 hours of wear. In addition, comfort scores were obtained using a visual analog scale.
RESULTS


Scleral lenses with oxygen permeability of 65 Dk resulted in greater corneal thickness (1.37 ± 1.25%) after 8 hours of wear versus ≥100 Dk materials (0.58 ± 0.99%; F = 17.215, P < .001) because of stromal thickening; edema with ≥100 Dk materials was associated with fluid reservoir depth (r = 0.231, P = .05). Fluid reservoir depth decreased similarly with all oxygen-permeable lenses from 325.6 ± 99.1 μm to 174.2 ± 100.8 μm after 8 hours of wear (F = 0.961, P = .44). Oxygen consumption reduced with ≤125 Dk lenses (χ = 604.196, P < .001). Soft and scleral lens wear had no effect on corneal curvature, corneal biomechanics, or ocular hyperemia (P > .05). Soft lenses were more comfortable than all the scleral lenses (P < .05), and the 180+ Dk lenses had the best comfort among the sclerals (P < .05).
CONCLUSIONS


A ≥125 Dk is advised for safe scleral lens daily wear. Scleral lens wear leads to an increase in corneal thickness, regardless of lens-material oxygen permeability because of the fluid reservoir depth.",2020,"Oxygen consumption reduced with ≤125 Dk lenses (χ = 604.196, P < .001).","['Fifteen masked participants aged 20.7 ± 2.3 years (10 female', 'Corneal Physiology']","['Scleral Lens Oxygen Permeability', 'silicone hydrogel lens compared with no lens wear on separate occasions']","['Oxygen consumption', 'corneal thickness, regardless of lens-material oxygen permeability', 'Fluid reservoir depth', 'corneal thickness and fluid reservoir depth, corneal curvature, objective bulbar and limbal redness, corneal biomechanics, and ocular surface oxygen consumption', 'corneal thickness', 'corneal curvature, corneal biomechanics, or ocular hyperemia', 'fluid reservoir depth']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness'}, {'cui': 'C0450437', 'cui_str': 'Lens material'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0442537', 'cui_str': 'Reservoir'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0443251', 'cui_str': 'Limbal'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0155169', 'cui_str': 'Ocular hyperemia'}]",15.0,0.0844741,"Oxygen consumption reduced with ≤125 Dk lenses (χ = 604.196, P < .001).","[{'ForeName': 'Sandeep K', 'Initials': 'SK', 'LastName': 'Dhallu', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.'}, {'ForeName': 'Sonia Trave', 'Initials': 'ST', 'LastName': 'Huarte', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.'}, {'ForeName': 'Paramdeep S', 'Initials': 'PS', 'LastName': 'Bilkhu', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.'}, {'ForeName': 'Nikolay', 'Initials': 'N', 'LastName': 'Boychev', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001557']
2124,32933342,Use of electronic recruitment methods in a clinical trial of adults with gout.,"BACKGROUND/AIMS


Electronic-based recruitment methods are increasingly utilized in clinical trials to recruit and enroll research participants. The cost-effectiveness of electronic-based methods and impact on sample generalizability is unknown. We compared recruitment yields, cost-effectiveness, and demographic characteristics across several electronic and traditional recruitment methods.
METHODS


We analyzed data from the diet gout trial recruitment campaign. The diet gout trial was a randomized, controlled, cross-over trial that examined the effects of a dietary approaches to stop hypertension (DASH)-like diet on uric acid levels in adults with gout. We used four electronic medical record and four non-electronic medical record-based recruitment methods to identify and recruit potentially eligible participants. We calculated the response rate, screening visit completion rate, and randomization rate for each method. We also determined cost per response, the screening, and randomization for each method. Finally, we compared the demographic characteristics among individuals who completed the screening visit by recruitment method.
RESULTS


Of the 294 adults who responded to the recruitment campaign, 51% were identified from electronic medical record-based methods. Patient portal messaging, an electronic medical record-based method, resulted in the highest response rate (4%), screening visit completion rate (37%), and randomization rate (21%) among these eight methods. Electronic medical record-based methods ($60) were more cost-effective per response than non-electronic medical record-based methods ($107). Electronic-based methods, including patient portal messaging and Facebook, had the highest proportion of White individuals screened (52% and 60%). Direct mail to non-active patient portal increased enrollment of traditionally under-represented groups, including both women and African Americans.
CONCLUSION


An electronic medical record-based recruitment strategy that utilized the electronic medical record for participant identification and postal mailing for participant outreach was cost-effective and increased participation of under-represented groups. This hybrid strategy represents a promising approach to improve the timely execution and broad generalizability of future clinical trials.",2020,Electronic medical record-based methods ($60) were more cost-effective per response than non-electronic medical record-based methods ($107).,"['women and African Americans', 'adults with gout', '294 adults who responded to the recruitment campaign, 51% were identified from electronic medical record-based methods']",['dietary approaches to stop hypertension (DASH)-like diet'],"['response rate, screening visit completion rate, and randomization rate', 'screening visit completion rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",294.0,0.25622,Electronic medical record-based methods ($60) were more cost-effective per response than non-electronic medical record-based methods ($107).,"[{'ForeName': 'Hailey N', 'Initials': 'HN', 'LastName': 'Miller', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Charleston', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Beiwen', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Gleason', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'White', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison Himmelfarb', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Ford', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Plante', 'Affiliation': 'Department of Medicine, Larner College of Medicine, The University of Vermont, Burlington, VT, USA.'}, {'ForeName': 'Allan C', 'Initials': 'AC', 'LastName': 'Gelber', 'Affiliation': 'Welch Center for Prevention, Epidemiology, and Clinical Research, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520956969']
2125,32937008,Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol.,"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with high incidence of multiorgan dysfunction and death. Angiotensin-converting enzyme 2 (ACE2), which facilitates SARS-CoV-2 host cell entry, may be impacted by angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), two commonly used antihypertensive classes. In a multicenter, international randomized controlled trial that began enrollment on March 31, 2020, participants are randomized to continuation vs withdrawal of their long-term outpatient ACEI or ARB upon hospitalization with COVID-19. The primary outcome is a hierarchical global rank score incorporating time to death, duration of mechanical ventilation, duration of renal replacement or vasopressor therapy, and multiorgan dysfunction severity. Approval for the study has been obtained from the Institutional Review Board of each participating institution, and all participants will provide informed consent. A data safety monitoring board has been assembled to provide independent oversight of the project.",2020,"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with high incidence of multiorgan dysfunction and death.",[],"['Angiotensin-converting enzyme 2 (ACE2', 'ACE inhibitors and ARBs']","['hierarchical global rank score incorporating time to death, duration of mechanical ventilation, duration of renal replacement or vasopressor therapy, and multiorgan dysfunction severity']",[],"[{'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.173724,"Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with high incidence of multiorgan dysfunction and death.","[{'ForeName': 'Jordana B', 'Initials': 'JB', 'LastName': 'Cohen', 'Affiliation': 'Renal-Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Hanff', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Corrales-Medina', 'Affiliation': 'Division of Infectious Diseases, University of Ottawa and The Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'William', 'Affiliation': 'Division of Cardiology, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Renna', 'Affiliation': 'Hypertension Unit, Department of Pathology, Hospital Español de Mendoza, National University of Cuyo, IMBECU-CONICET, Mendoza, Argentina.'}, {'ForeName': 'Nelson R', 'Initials': 'NR', 'LastName': 'Rosado-Santander', 'Affiliation': 'Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, EsSalud, Arequipa, Perú.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Rodriguez-Mori', 'Affiliation': 'Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Perú.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Spaak', 'Affiliation': 'Department of Clinical Sciences, Danderyd University Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Andrade-Villanueva', 'Affiliation': 'Universidad de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Tara I', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': 'Division of Nephrology, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Barbagelata', 'Affiliation': 'Universidad Católica de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Alfonso', 'Affiliation': 'Cardiology Division, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bernales-Salas', 'Affiliation': 'Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, EsSalud, Arequipa, Perú.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Coacalla', 'Affiliation': 'Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, EsSalud, Arequipa, Perú.'}, {'ForeName': 'Carlos Augusto', 'Initials': 'CA', 'LastName': 'Castro-Callirgos', 'Affiliation': 'Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Perú.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Tupayachi-Venero', 'Affiliation': 'Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Perú.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Medina', 'Affiliation': 'Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Perú.'}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': 'Valdivia', 'Affiliation': 'Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Perú.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Villavicencio', 'Affiliation': 'Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Perú.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Vasquez', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Harhay', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Chittams', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Sharkoski', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'James Brian', 'Initials': 'JB', 'LastName': 'Byrd', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Edmonston', 'Affiliation': 'Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Sweitzer', 'Affiliation': 'Division of Cardiology, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.14011']
2126,32939228,Waking Up from Dreamland: Opioid Addiction Precipitance and Support for Redistributive Drug Treatment.,"Motivated by the historical components of the ongoing U.S. opioid epidemic, this study examines how public support for redistributive drug treatment changes with awareness that someone's opioid addiction started with a legally acquired prescription. Using different versions of a vignette, we vary in a randomized design whether someone's addiction to painkillers started with a legally acquired prescription or with the decision to take pills from a friend. After reading the vignette, participants expressed their level of support for a policy that uses income redistribution to fund a program that provides the person in the vignette with drug treatment. We find that participants are less likely to support redistributive drug treatment when a prescription precipitates the addiction. The results imply that emphasizing the medical establishment's role in the opioid epidemic may actually make people less likely to favor using redistributive drug treatment to provide support.",2019,"After reading the vignette, participants expressed their level of support for a policy that uses income redistribution to fund a program that provides the person in the vignette with drug treatment.",[],[],[],[],[],[],,0.0312429,"After reading the vignette, participants expressed their level of support for a policy that uses income redistribution to fund a program that provides the person in the vignette with drug treatment.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chavanne', 'Affiliation': 'Department of Economics, Connecticut College, New London, CT, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Goodyear', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Science, Brown University, Providence, RI, USA.'}]",Journal of drug policy analysis,['10.1515/jdpa-2019-0010']
2127,32942788,Relationship Between Epidural Steroid Dose and Suppression of Hypothalamus-Pituitary-Adrenal Axis.,"BACKGROUND


The suppression of hypothalamic-pituitary-adrenal (HPA) axis is a common complication associated with epidural steroid injections (ESIs). However, the effect of different doses is unknown.
OBJECTIVES


The primary objective was to compare the differences in the duration of HPA suppression following treatment with different doses of ESI; triamcinolone acetate (TA) 40 mg and TA 20 mg. The secondary objectives were to compare the extent of salivary cortisol (SC) reduction, the incidence of adrenal insufficiency (AI), and the differences in a numeric rating scale (NRS) depending on the varying levels of TA dose used for ESI.
STUDY DESIGN


A double-blind, parallel-group, randomized controlled trial.
SETTING


Pain clinics in a university hospital.
METHODS


The patients were treated with TA epidurally and divided into 2 groups (T20 and T40) depending on the dose of TA (20 mg and 40 mg). The SC concentration was measured before and after ESI to calculate the duration of HPA axis suppression, the extent of SC concentration reduction, and the SC recovery rate. Additionally, NRS and adrenocorticotropic hormone stimulation tests were used.
RESULTS


Thirty patients were analyzed. The T40 group showed longer HPA suppression (19.7 ± 3.1 days) compared with that of the T20 group (8.0 ± 2.4 days). The recovery rate of the T40 group was lower than that of the T20 group (P < 0.015). However, there was no difference in the extent of reduction in SC concentration after ESI, the occurrence of AI, and pain reduction.
LIMITATIONS


There were selection bias and no placebo control.
CONCLUSIONS


Although the difference in pain relief according to the ESI dose is not significant, the HPA suppression is prolonged with a higher dose than a lower dose, and the recovery is slower. Therefore, the time interval between consecutive ESIs should be adjusted depending on the steroid dose to ameliorate the adverse effects of steroids.",2020,The recovery rate of the T40 group was lower than that of the T20 group (P < 0.015).,"['Thirty patients were analyzed', 'Pain clinics in a university hospital']","['TA', 'ESI; triamcinolone acetate (TA']","['duration of HPA axis suppression', 'SC concentration after ESI, the occurrence of AI, and pain reduction', 'pain relief', 'SC concentration', 'longer HPA suppression', 'duration of HPA suppression', 'recovery rate', 'extent of salivary cortisol (SC) reduction, the incidence of adrenal insufficiency (AI), and the differences in a numeric rating scale (NRS) depending on the varying levels of TA dose used for ESI', 'HPA suppression']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3665848', 'cui_str': 'Hypothalamic pituitary adrenal axis suppression'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0271738', 'cui_str': 'Hypocortisolism secondary to another disorder'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",30.0,0.0473564,The recovery rate of the T40 group was lower than that of the T20 group (P < 0.015).,"[{'ForeName': 'Sung-Eun', 'Initials': 'SE', 'LastName': 'Sim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo Ju', 'Initials': 'HJ', 'LastName': 'Hong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Kyungmoon', 'Initials': 'K', 'LastName': 'Roh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jaeho', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Ho Sik', 'Initials': 'HS', 'LastName': 'Moon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}]",Pain physician,[]
2128,32942789,"Comparing the Safety and Effectiveness of Radiofrequency Thermocoagulation on Genicular Nerve, Intraarticular Pulsed Radiofrequency with Steroid Injection in the Pain Management of Knee Osteoarthritis.","BACKGROUND


Knee osteoarthritis (KOA) is characterized by the clinical symptoms of chronic knee pain and knee dysfunction, leading to disability and influencing the quality of life in severe cases. Radiofrequency treatment is a new method to reduce KOA-related pain and partially improve knee joint dysfunction without adverse effect.
OBJECTIVE


The present study aimed to assess the treatment efficacy of radiofrequency thermocoagulation on the genicular nerve (RFTGN) and intraarticular pulsed radiofrequency (IAPRF) for KOA.
STUDY DESIGN


Retrospective comparative study design.
SETTING


This study took place at Shengjing Hospital of China Medical University.
METHOD


KOA patients were randomly assigned to the RFTGN, IAPRF, and intraarticular steroid injection (IAS) groups. All procedures were performed under the guidance of computed tomography (CT). The observation indicators of this study were the numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE). The time points for the assessment were 1-week, 1-month, 3-months, and 6-months after the treatment.
RESULTS


The postoperative NRS scores in the 3 groups decreased significantly at all the observation time points as compared to the pretreatment scores (P < 0.05). For the patients in the IAS group, the analgesic effect was in a rebound trend, which was the best at 1-week posttreatment, and was close to the preoperative level at 6-months posttreatment. The short-term (1 week or 1 month) analgesic effect of the RFTGN group was better than that of the IAPRF group, and was similar in the long-term (3 or 6 months). The long-term analgesic effect of RFTGN and IAPRF groups was better than that of IAS group. The results of the OKS score were similar to the NRS score. The RFTGN group showed markedly improved knee function in the long-term than the IAPRF and IAS groups. The short-term treatment satisfaction was similar in each group, and some differences were detected between the groups with respect to long-term treatment satisfaction.
LIMITATION


This study was a single-center retrospective study with a relatively small sample cohort and short follow-up periodCONCLUSION: Both RFTGN and IAPRF could alleviate the knee joint pain and improve the knee joint dysfunction; however, the treatment efficacy of RFTGN was better than that of IAPRF.",2020,The postoperative NRS scores in the 3 groups decreased significantly at all the observation time points as compared to the pretreatment scores (P < 0.05).,"['Knee osteoarthritis (KOA', 'KOA patients', 'Knee Osteoarthritis', 'place at Shengjing Hospital of China Medical University']","['radiofrequency thermocoagulation', 'Radiofrequency Thermocoagulation', 'IAS', 'intraarticular pulsed radiofrequency (IAPRF', 'RFTGN and IAPRF', 'computed tomography (CT', 'Steroid Injection', 'Radiofrequency treatment', 'RFTGN, IAPRF, and intraarticular steroid injection (IAS', 'IAPRF']","['numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE', 'analgesic effect', 'knee function', 'knee joint pain', 'short-term treatment satisfaction', 'knee joint dysfunction', 'postoperative NRS scores', 'OKS score']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0908952', 'cui_str': 'iodoazidosalmeterol'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0214505,The postoperative NRS scores in the 3 groups decreased significantly at all the observation time points as compared to the pretreatment scores (P < 0.05).,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Guangxiao', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Zhenkai', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Shimeng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}]",Pain physician,[]
2129,32945632,Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma.,"BACKGROUND


Platinum-based chemotherapy is standard-of-care first-line treatment for advanced urothelial carcinoma. However, progression-free survival and overall survival are limited by chemotherapy resistance.
METHODS


In a phase 3 trial, we randomly assigned patients with unresectable locally advanced or metastatic urothelial cancer who did not have disease progression with first-line chemotherapy (four to six cycles of gemcitabine plus cisplatin or carboplatin) to receive best supportive care with or without maintenance avelumab. The primary end point was overall survival, assessed among all patients who underwent randomization (overall population) and among those with tumors positive for programmed cell death ligand 1 (PD-L1). Secondary end points included progression-free survival and safety.
RESULTS


Among all 700 patients who underwent randomization, the addition of maintenance avelumab to best supportive care significantly prolonged overall survival as compared with best supportive care alone (control). Overall survival at 1 year was 71.3% in the avelumab group and 58.4% in the control group (median overall survival, 21.4 months vs. 14.3 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.86; P = 0.001). Avelumab also significantly prolonged overall survival in the PD-L1-positive population; overall survival at 1 year was 79.1% in the avelumab group and 60.4% in the control group (hazard ratio, 0.56; 95% CI, 0.40 to 0.79; P<0.001). The median progression-free survival was 3.7 months in the avelumab group and 2.0 months in the control group in the overall population (hazard ratio for disease progression or death, 0.62; 95% CI, 0.52 to 0.75) and 5.7 months and 2.1 months, respectively, in the PD-L1-positive population (hazard ratio, 0.56; 95% CI, 0.43 to 0.73). The incidence of adverse events from any cause was 98.0% in the avelumab group and 77.7% in the control group; the incidence of adverse events of grade 3 or higher was 47.4% and 25.2%, respectively.
CONCLUSIONS


Maintenance avelumab plus best supportive care significantly prolonged overall survival, as compared with best supportive care alone, among patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy. (Funded by Pfizer and Merck [Darmstadt, Germany]; JAVELIN Bladder 100 ClinicalTrials.gov number, NCT02603432.).",2020,"CONCLUSIONS


Maintenance avelumab plus best supportive care significantly prolonged overall survival, as compared with best supportive care alone, among patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy.","['patients with unresectable locally advanced or metastatic urothelial cancer who did not have disease progression with first-line chemotherapy (four to six cycles of', 'patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy', 'Advanced or Metastatic Urothelial Carcinoma', 'advanced urothelial carcinoma']","['Avelumab Maintenance Therapy', 'supportive care with or without maintenance avelumab', 'gemcitabine plus cisplatin or carboplatin', 'Platinum-based chemotherapy']","['progression-free survival and safety', 'Overall survival', 'incidence of adverse events', 'median progression-free survival', 'progression-free survival and overall survival', 'survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",700.0,0.381542,"CONCLUSIONS


Maintenance avelumab plus best supportive care significantly prolonged overall survival, as compared with best supportive care alone, among patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Voog', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Caserta', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Begoña P', 'Initials': 'BP', 'LastName': 'Valderrama', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Haralabos', 'Initials': 'H', 'LastName': 'Kalofonos', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Siniša', 'Initials': 'S', 'LastName': 'Radulović', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Demey', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ullén', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Loriot', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Srikala S', 'Initials': 'SS', 'LastName': 'Sridhar', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Tsuchiya', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Kopyltsov', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Jeanny B', 'Initials': 'JB', 'LastName': 'Aragon-Ching', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Laliberte', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Fowst', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Costa', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Blake-Haskins', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'di Pietro', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Grivas', 'Affiliation': ""From Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St. Bartholomew's Hospital, London (T.P.); Sungkyunkwan University Samsung Medical Center, Seoul, South Korea (S.H.P.); Centre Jean Bernard Clinique Victor Hugo, Le Mans (E.V.), and Gustave Roussy, INSERM Unité 981, Université Paris-Saclay, Villejuif (Y.L.) - both in France; the Medical Oncology Unit, Azienda Ospedaliera S. Maria, Terni (C.C.), and Pfizer, Milan (C.F., A.P.) - both in Italy; the Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain (B.P.V.); the Department of Clinical Medicine, Macquarie University, Sydney (H.G.); the Division of Oncology, Department of Medicine, University General Hospital of Patras, Patras, Greece (H.K.); the Institute for Oncology and Radiology of Serbia, Belgrade (S.R.); the Department of Medical Oncology, Algemeen Ziekenhuis Klina, Brasschaat, Belgium (W.D.); Patient Area Pelvic Cancer, Theme Cancer, Karolinska University Hospital, and the Department of Oncology-Pathology, Karolinska Institute, Solna, Sweden (A.U.); Princess Margaret Cancer Centre, University Health Network, Toronto (S.S.S.); the Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan (N.T.); the State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia (E.K.); the Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York (C.N.S.); the Department of Medical Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (J.B.), and Pfizer, Cambridge (R.L., J.W.) - both in Massachusetts; Inova Schar Cancer Institute, Fairfax, VA (J.B.A.-C.); Yale Cancer Center, New Haven (D.P.P.), and Pfizer, Groton (B.H.) - both in Connecticut; Pfizer, La Jolla, CA (C.D., J.A.B.-H.); Pfizer, Porto Salvo, Portugal (N.C.); and the Department of Medicine, Division of Oncology, University of Washington, and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle (P.G.).""}]",The New England journal of medicine,['10.1056/NEJMoa2002788']
2130,32945775,Effect of Voluntary Participation on Mobile Health Care in Diabetes Management: Randomized Controlled Open-Label Trial.,"BACKGROUND


The role of mobile health care (mHealth) in glycemic control has been investigated, but its impact on self-management skills and its psychological aspects have not been studied.
OBJECTIVE


We evaluated the efficacy of mHealth-based diabetes self-management education and the effect of voluntary participation on its effects.
METHODS


This study was a randomized controlled open-label trial conducted for 6 months at Kangbuk Samsung Hospital. Participants in the control group (n=31) maintained their previous diabetes management strategies. Participants in the intervention group (n=41) additionally received mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals. The primary outcome was change in glycated hemoglobin (HbA 1c ) level over 6 months between the 2 groups (intervention versus control) and within each group (at 6 months versus baseline). The secondary outcomes were changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes) over 6 months between groups and within each group.
RESULTS


A total of 66 participants completed this study. HbA 1c  (P=.04), total cholesterol level (P=.04), and Problem Areas in Diabetes scores (P=.02) significantly decreased; total diet (P=.03) and self-monitoring of blood glucose level scores (P=.01), based on the Summary of Diabetes Self-Care Activities Questionnaire, markedly increased within the intervention group. These significant changes were observed in self-motivated participants who were recruited voluntarily via advertisements.
CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03468283; http://clinicaltrials.gov/ct2/show/NCT03468283.",2020,"CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
","['6 months at Kangbuk Samsung Hospital', 'Participants in the control group (n=31) maintained their previous diabetes management strategies', 'Diabetes Management', '66 participants completed this study']","['Voluntary Participation', 'mHealth-based diabetes self-management education', 'mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals']","['Mobile Health Care', 'total cholesterol level', 'Diabetes scores', 'glycated hemoglobin (HbA 1c ) level', 'self-monitoring of blood glucose level scores', 'Diabetes Self-Care Activities Questionnaire', 'changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",66.0,0.0783678,"CONCLUSIONS


mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.
","[{'ForeName': 'Da Young', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Hyun', 'Initials': 'SH', 'LastName': 'Yoo', 'Affiliation': 'Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyong Pil', 'Initials': 'KP', 'LastName': 'Min', 'Affiliation': 'Huraypositive Inc, Seoul, Republic of Korea.'}, {'ForeName': 'Cheol-Young', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",JMIR mHealth and uHealth,['10.2196/19153']
2131,32955455,Social and Behavior Change Communication Interventions Delivered Face-to-Face and by a Mobile Phone to Strengthen Vaccination Uptake and Improve Child Health in Rural India: Randomized Pilot Study.,"BACKGROUND


In resource-poor settings, lack of awareness and low demand for services constitute important barriers to expanding the coverage of effective interventions. In India, childhood immunization is a priority health strategy with suboptimal uptake.
OBJECTIVE


To assess study feasibility and key implementation outcomes for the Tika Vaani model, a new approach to educate and empower beneficiaries to improve immunization and child health.
METHODS


A cluster-randomized pilot trial with a 1:1 allocation ratio was conducted in rural Uttar Pradesh, India, from January to September 2018. Villages were randomly assigned to either the intervention or control group. In each participating village, surveyors conducted a complete enumeration to identify eligible households and requested participation before randomization. Interventions were designed through formative research using a social marketing approach and delivered over 3 months using strategies adapted to disadvantaged populations: (1) mobile health (mHealth): entertaining educational audio capsules (edutainment) and voice immunization reminders via mobile phone and (2) face-to-face: community mobilization activities, including 3 small group meetings offered to each participant. The control group received usual services. The main outcomes were prespecified criteria for feasibility of the main study (recruitment, randomization, retention, contamination, and adoption). Secondary endpoints tested equity of coverage and changes in intermediate outcomes. Statistical methods included descriptive statistics to assess feasibility, penalized logistic regression and ordered logistic regression to assess coverage, and generalized estimating equation models to assess changes in intermediate outcomes.
RESULTS


All villages consented to participate. Gaps in administrative data hampered recruitment; 14.0% (79/565) of recorded households were nonresident. Only 1.4% (8/565) of households did not consent. A total of 387 households (184 intervention and 203 control) with children aged 0 to 12 months in 26 villages (13 intervention and 13 control) were included and randomized. The end line survey occurred during the flood season; 17.6% (68/387) of the households were absent. Contamination was less than 1%. Participation in one or more interventions was 94.0% (173/184), 78.3% (144/184) for the face-to-face strategy, and 67.4% (124/184) for the mHealth strategy. Determinants including place of residence, mobile phone access, education, and female empowerment shaped intervention use; factors operated differently for face-to-face and mHealth strategies. For 11 of 13 intermediate outcomes, regression results showed significantly higher basic health knowledge among the intervention group, supporting hypothesized causal mechanisms.
CONCLUSIONS


A future trial of a new intervention model is feasible. The interventions could strengthen the delivery of immunization and universal primary health care. Social and behavior change communication via mobile phones proved viable and contributed to standardization and scalability. Face-to-face interactions remain necessary to achieve equity and reach, suggesting the need for ongoing health system strengthening to accompany the introduction of communication technologies.
TRIAL REGISTRATION


International Standard Randomized Controlled Trial Number (ISRCTN) 44840759; https://doi.org/10.1186/ISRCTN44840759.",2020,"For 11 of 13 intermediate outcomes, regression results showed significantly higher basic health knowledge among the intervention group, supporting hypothesized causal mechanisms.
","['Rural India', '387 households (184 intervention and 203 control) with children aged 0 to 12 months in 26 villages (13 intervention and 13 control', 'rural Uttar Pradesh, India, from January to September 2018']","['Social and Behavior Change Communication Interventions Delivered Face-to-Face and by a Mobile Phone to Strengthen Vaccination Uptake', 'social marketing approach and delivered over 3 months using strategies adapted to disadvantaged populations: (1) mobile health (mHealth): entertaining educational audio capsules (edutainment) and voice immunization reminders via mobile phone and (2) face-to-face: community mobilization activities', 'usual services']","['equity of coverage and changes in intermediate outcomes', 'basic health knowledge', 'feasibility of the main study (recruitment, randomization, retention, contamination, and adoption']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}]",387.0,0.0659548,"For 11 of 13 intermediate outcomes, regression results showed significantly higher basic health knowledge among the intervention group, supporting hypothesized causal mechanisms.
","[{'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Johri', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.""}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Chandra', 'Affiliation': 'Independent consultant, New Delhi, India.'}, {'ForeName': 'Karna Georges', 'Initials': 'KG', 'LastName': 'Kone', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.""}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Sylvestre', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montréal, QC, Canada.""}, {'ForeName': 'Alok K', 'Initials': 'AK', 'LastName': 'Mathur', 'Affiliation': 'Indian Institute of Health Management Research University, Jaipur, India.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Harper', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Nandi', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, QC, Canada.'}]",JMIR mHealth and uHealth,['10.2196/20356']
2132,32955554,Efficacy of Smartphone Applications for Smoking Cessation: A Randomized Clinical Trial.,"Importance


Smoking is a leading cause of premature death globally. Smartphone applications for smoking cessation are ubiquitous and address barriers to accessing traditional treatments, yet there is limited evidence for their efficacy.
Objective


To determine the efficacy of a smartphone application for smoking cessation based on acceptance and commitment therapy (ACT) vs a National Cancer Institute smoking cessation application based on US clinical practice guidelines (USCPG).
Design, Setting, and Participants


A 2-group, stratified, double-blind, individually randomized clinical trial was conducted from May 27, 2017, to September 28, 2018, among 2415 adult cigarette smokers (n = 1214 for the ACT-based smoking cessation application group and n = 1201 for the USCPG-based smoking cessation application group) with 3-, 6-, and 12-month postrandomization follow-up. The study was prespecified in the trial protocol. Follow-up data collection started on August 26, 2017, and ended at the last randomized participant's 12-month follow-up survey on December 23, 2019. Data were analyzed from February 25 to April 3, 2020. The primary analysis was performed on a complete-case basis, with intent-to-treat missing as smoking and multiple imputation sensitivity analyses.
Interventions


iCanQuit, an ACT-based smoking cessation application, which taught acceptance of smoking triggers, and the National Cancer Institute QuitGuide, a USCPG-based smoking cessation application, which taught avoidance of smoking triggers.
Main Outcomes and Measures


The primary outcome was self-reported 30-day point prevalence abstinence (PPA) at 12 months after randomization. Secondary outcomes were 7-day PPA at 12 months after randomization, prolonged abstinence, 30-day and 7-day PPA at 3 and 6 months after randomization, missing data imputed with multiple imputation or coded as smoking, and cessation of all tobacco products (including e-cigarettes) at 12 months after randomization.
Results


Participants were 2415 adult cigarette smokers (1700 women [70.4%]; 1666 White individuals [69.0%] and 868 racial/ethnic minorities [35.9%]; mean [SD] age at enrollment, 38.2 [10.9] years) from all 50 US states. The 3-month follow-up data retention rate was 86.7% (2093), the 6-month retention rate was 88.4% (2136), and the 12-month retention rate was 87.2% (2107). For the primary outcome of 30-day PPA at the 12-month follow-up, iCanQuit participants had 1.49 times higher odds of quitting smoking compared with QuitGuide participants (28.2% [293 of 1040] vs 21.1% [225 of 1067]; odds ratio [OR], 1.49; 95% CI, 1.22-1.83; P < .001). Effect sizes were very similar and statistically significant for 7-day PPA at the 12-month follow-up (OR, 1.35; 95% CI, 1.12-1.63; P = .002), prolonged abstinence at the 12-month follow-up (OR, 2.00; 95% CI, 1.45-2.76; P < .001), abstinence from all tobacco products (including e-cigarettes) at the 12-month follow-up (OR, 1.60; 95% CI, 1.28-1.99; P < .001), 30-day PPA at 3-month follow-up (OR, 2.20; 95% CI, 1.68-2.89; P < .001), 30-day PPA at 6-month follow-up (OR, 2.03; 95% CI, 1.63-2.54; P < .001), 7-day PPA at 3-month follow-up (OR, 2.04; 95% CI, 1.64-2.54; P < .001), and 7-day PPA at 6-month follow-up (OR, 1.73; 95% CI, 1.42-2.10; P < .001).
Conclusions and Relevance


This trial provides evidence that, compared with a USCPG-based smartphone application, an ACT-based smartphone application was more efficacious for quitting cigarette smoking and thus can be an impactful treatment option.
Trial Registration


ClinicalTrials.gov Identifier: NCT02724462.",2020,"Effect sizes were very similar and statistically significant for 7-day PPA at the 12-month follow-up (OR, 1.35; 95% CI, 1.12-1.63; P = .002), prolonged abstinence at the 12-month follow-up (OR, 2.00; 95% CI, 1.45-2.76; P < .001), abstinence from all tobacco products (including e-cigarettes) at the 12-month follow-up (OR, 1.60; 95% CI, 1.28-1.99; P < .001), 30-day PPA at 3-month follow-up (OR, 2.20; 95% CI, 1.68-2.89; P < .001), 30-day PPA at 6-month follow-up (OR, 2.03; 95% CI, 1.63-2.54; P < .001), 7-day PPA at 3-month follow-up (OR, 2.04; 95% CI, 1.64-2.54; P < .001), and 7-day PPA at 6-month follow-up (OR, 1.73; 95% CI, 1.42-2.10; P < .001).
","['Participants were 2415 adult cigarette smokers (1700 women [70.4%]; 1666 White individuals [69.0%] and 868 racial/ethnic minorities [35.9%]; mean [SD] age at enrollment, 38.2 [10.9] years) from all 50 US states', 'Smoking Cessation', '27, 2017, to September 28, 2018, among 2415 adult cigarette smokers (n\u2009=\u20091214 for the ACT-based smoking cessation application group and n\u2009=\u20091201 for the USCPG-based smoking cessation application group) with']","['smartphone application', 'USCPG-based smartphone application, an ACT-based smartphone application', 'Smartphone Applications']","['30-day PPA', '6-month retention rate', '12-month retention rate', 'self-reported 30-day point prevalence abstinence (PPA', 'quitting smoking', 'data retention rate', '7-day PPA', 'prolonged abstinence', '7-day PPA at 12 months after randomization, prolonged abstinence, 30-day and 7-day PPA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282451', 'cui_str': 'Clinical Practice Guideline'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0282451', 'cui_str': 'Clinical Practice Guideline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",2415.0,0.137323,"Effect sizes were very similar and statistically significant for 7-day PPA at the 12-month follow-up (OR, 1.35; 95% CI, 1.12-1.63; P = .002), prolonged abstinence at the 12-month follow-up (OR, 2.00; 95% CI, 1.45-2.76; P < .001), abstinence from all tobacco products (including e-cigarettes) at the 12-month follow-up (OR, 1.60; 95% CI, 1.28-1.99; P < .001), 30-day PPA at 3-month follow-up (OR, 2.20; 95% CI, 1.68-2.89; P < .001), 30-day PPA at 6-month follow-up (OR, 2.03; 95% CI, 1.63-2.54; P < .001), 7-day PPA at 3-month follow-up (OR, 2.04; 95% CI, 1.64-2.54; P < .001), and 7-day PPA at 6-month follow-up (OR, 1.73; 95% CI, 1.42-2.10; P < .001).
","[{'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'Bricker', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, Washington.'}, {'ForeName': 'Noreen L', 'Initials': 'NL', 'LastName': 'Watson', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, Washington.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Mull', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, Washington.'}, {'ForeName': 'Brianna M', 'Initials': 'BM', 'LastName': 'Sullivan', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, Washington.'}, {'ForeName': 'Jaimee L', 'Initials': 'JL', 'LastName': 'Heffner', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, Washington.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.4055']
2133,32955601,Ultrasound-guided erector spinae block versus mid-transverse process to pleura block for postoperative analgesia in lumbar spinal surgery.,"BACKGROUND


In recent years, promising results were achieved with the use of ultrasound (US)-guided interfascial plane blocks for effective postoperative analgesia in several surgeries. Erector spina plane (ESP) block and mid-transverse to pleura plane (MTP) block are the latest techniques in this area. The aim of this prospective and randomized study was to compare the postoperative analgesic efficacy of bilateral ESP and MTP blocks in patients undergoing lumbar spinal surgery under general anesthesia (GA).
METHODS


A total of 120 adult patients were included in the study and randomized into 3 groups: group ESP (n = 40), group MTP (n = 40) and group Control (n = 40). The patients in the group ESP received a bilateral block by injecting 20 ml of 0.25% bupivacaine at a vertebrae level in the mid-point of the incision before GA. The same LA was administrated bilaterally at the T12/L1 level in the group MTP. Postoperatively, a multimodal analgesic regimen including an intravenous tramadol patient-controlled analgesia (PCA), paracetamol and dexketoprofen was used in all groups. Postoperative pain was assessed using a visual analogue scale (VAS) during the first 48 postoperative hours. Pethidine was used as a rescue analgesic when VAS score was >3. Primary outcome measure was mean pain scores. Secondary outcome measures were consumption of rescue analgesic and the amount of tramadol delivered by PCA. A p < 0.05 was considered statistically significant.
RESULTS


Mean VAS scores were significantly higher in the group Control than in the group MTP and group ESP at all-time points during 48 h (Control > MTP > ESP; p < 0.001). Mean VAS scores were lower in group ESP than group MTP in postoperative 12 h (p < 0.001). Rescue analgesic consumption, number of bolus demand on PCA, PCA bolus demand dose, total PCA dose, and complications related to opioid consumption were highest in control group and lowest in ESP group (Control > MTP > ESP; p < 0.001).
CONCLUSION


Both ESP and MTP blocks provided effective pain relief after lumbar spinal surgery but the ESP block was superior to MTP block regarding postoperative analgesia in the first 24 h.",2020,Both ESP and MTP blocks provided effective pain relief after lumbar spinal surgery but the ESP block was superior to MTP block regarding postoperative analgesia in the first 24 h.,"['patients undergoing lumbar spinal surgery under general anesthesia (GA', 'A\xa0total of 120 adult patients', 'lumbar spinal surgery']","['ultrasound (US)-guided interfascial plane blocks', 'bilateral block by injecting 20\u202fml of 0.25% bupivacaine', 'Pethidine', 'tramadol patient-controlled analgesia (PCA), paracetamol and dexketoprofen', 'Ultrasound-guided erector spinae block versus mid-transverse process to pleura block', 'ESP', 'ESP and MTP blocks', 'bilateral ESP and MTP blocks']","['postoperative analgesic efficacy', 'mean pain scores', 'visual analogue scale (VAS', 'effective pain relief', 'Mean VAS scores', 'Rescue analgesic consumption, number of bolus demand on PCA, PCA bolus demand dose, total PCA dose, and complications related to opioid consumption', 'Erector spina plane (ESP) block and mid-transverse to pleura plane (MTP) block', 'Postoperative pain', 'consumption of rescue analgesic and the amount of tramadol delivered by PCA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0032225', 'cui_str': 'Pleural structure'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0032225', 'cui_str': 'Pleural structure'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",120.0,0.0622543,Both ESP and MTP blocks provided effective pain relief after lumbar spinal surgery but the ESP block was superior to MTP block regarding postoperative analgesia in the first 24 h.,"[{'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Eskin', 'Affiliation': 'Gülhane Medical School, University of Medical Science, Ankara, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ceylan', 'Affiliation': 'Gülhane Medical School, University of Medical Science, Ankara, Turkey.'}, {'ForeName': 'M Ö', 'Initials': 'MÖ', 'LastName': 'Özhan', 'Affiliation': 'Özel Çankaya Hospital, Ankara, Turkey. metozhan2003@yahoo.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Atik', 'Affiliation': 'Balıkesir University Medical School, Balıkesir, Turkey.'}]",Der Anaesthesist,['10.1007/s00101-020-00848-w']
2134,32955643,Impact of music-based intervention on verbal memory: an experimental behavioral study with older adults.,"Normal age-related declines have been reported in different cognitive functions, such as episodic memory. Some environmental factors have the potential to reduce cognitive decline and promote healthy aging. In this research, we employed musical improvisation as a focal music-based intervention to explore its effects as a modulator of verbal memory. We evaluated two types of verbal memory: a neutral one, employing the Rey Auditory Verbal Learning Test (Study 1), and an emotional one, implementing the Spanish version of Affective Norms for English Words (Study 2) in a volunteer group of older adults. After the acquisition of neutral (Study 1) or emotional (Study 2) verbal information, the participants were exposed to musical improvisation (experimental condition) or two control conditions (rhythmic reproduction as a musically active control condition or a rest condition as a passive control condition) for 3 min. Then, memory was evaluated through two memory tasks (immediate and deferred free-recall and recognition tests). In both studies, we compared memory performance among musicians (with five or more years of music training) and non-musicians. We found a significant improvement in neutral verbal memory among participants involved in musical improvisation, who remembered more words than those in the control conditions. Differences were also found according to the musical experience of the sample, with musicians outperforming non-musicians. The current research supports the late-life cognitive benefits of music-based intervention and music training.",2020,"We found a significant improvement in neutral verbal memory among participants involved in musical improvisation, who remembered more words than those in the control conditions.","['older adults', 'volunteer group of older adults']","['verbal memory: a neutral one, employing the Rey Auditory Verbal Learning Test (Study 1), and an emotional one, implementing the Spanish version of Affective Norms for English Words (Study 2', 'music-based intervention', 'music-based intervention and music training', 'neutral (Study 1) or emotional (Study 2) verbal information, the participants were exposed to musical improvisation (experimental condition) or two control conditions (rhythmic reproduction as a musically active control condition or a rest condition as a passive control condition']","['verbal memory', 'neutral verbal memory']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}]",,0.0336298,"We found a significant improvement in neutral verbal memory among participants involved in musical improvisation, who remembered more words than those in the control conditions.","[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Diaz Abrahan', 'Affiliation': 'Lab. Interdisciplinario de Neurociencia Cognitiva (LINC), Centro de Estudios Multidisciplinarios en Sistemas Complejos y Ciencias del Cerebro (CEMSC3), Instituto de Ciencias Físicas (ICIFI), Escuela de Ciencia y Tecnología (ECyT), Universidad de San Martín (UNSAM), 25 de Mayo 1169, 1er piso, Of. 18, San Martin, 1650, Argentina. abrahanveronika@conicet.gov.ar.'}, {'ForeName': 'Favio', 'Initials': 'F', 'LastName': 'Shifres', 'Affiliation': 'Laboratorio para el Estudio de la Experiencia Musical (LEEM), Departamento de Música, Facultad de Bellas Artes (FBA), Universidad Nacional de La Plata (UNLP), La Plata, Argentina.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Justel', 'Affiliation': 'Lab. Interdisciplinario de Neurociencia Cognitiva (LINC), Centro de Estudios Multidisciplinarios en Sistemas Complejos y Ciencias del Cerebro (CEMSC3), Instituto de Ciencias Físicas (ICIFI), Escuela de Ciencia y Tecnología (ECyT), Universidad de San Martín (UNSAM), 25 de Mayo 1169, 1er piso, Of. 18, San Martin, 1650, Argentina.'}]",Cognitive processing,['10.1007/s10339-020-00993-5']
2135,32955672,Does the Length of the Common Channel as Part of the Total Alimentary Tract Matter? One Year Results from the Multicenter Dutch Common Channel Trial (DUCATI) Comparing Standard Versus Distal Roux-en-Y Gastric Bypass with Similar Biliopancreatic Bowel Limb Lengths.,"PURPOSE


Although the laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is the gold-standard bariatric procedure, it remains uncertain what the optimal bowel limb lengths are to accomplish maximal weight loss while minimizing nutritional deficiencies and related gastro-intestinal complaints. The aim of this randomized controlled multicenter trial is to investigate the effect of significant lengthening of the length of the Roux limb (RL) at the cost of the length of the common channel (CC) while keeping the biliopancreatic limb (BPL) lengths the same on both study arms.
METHODS


Four hundred forty-four patients were randomized to receive either a Very Long Roux Limb LRYGB (VLRL-LRYGB) (variable RL length, BPL 60 cm, and CC 100 cm) or a Standard LRYGB (S-LRYGB) (RL 150 cm, BPL 60 cm, and a variable CC length). Results at 1-year follow-up for weight loss, effect on obesity-related comorbid conditions, complications, re-operation rate, malnutrition rate, and re-admission rate were investigated.
RESULTS


Weight loss at 1-year showed no significant differences for %EWL (84.3% versus 85.3%, p = 0.72) and %TWL (34.2% versus 33.6%, p = 0.359) comparing VLRL-LRYGB versus S-LRYGB. Malabsorption requiring surgical bowel length adjustment was observed in 1.4% in VLRL-LRYGB group versus 0.9% in S-LRYGB group (p = 0.316).
CONCLUSION


Significant lengthening of the RL at the cost of the common channel seems to have no effect on the weight loss at 1-year follow-up, which supports the theory that absorption of nutrients also occurs in the RL. Nevertheless, long-term results of the VLRL-LRYGB have to be awaited to draw final conclusions as part of the discussion towards optimal limb length in LRYGB surgery.",2020,"Significant lengthening of the RL at the cost of the common channel seems to have no effect on the weight loss at 1-year follow-up, which supports the theory that absorption of nutrients also occurs in the RL.",['Four hundred forty-four patients'],"['laparoscopic Roux-en-Y Gastric Bypass (LRYGB', 'Very Long Roux Limb LRYGB (VLRL-LRYGB) (variable RL length, BPL 60\xa0cm, and CC 100\xa0cm) or a Standard LRYGB (S-LRYGB', 'significant lengthening of the length of the Roux limb (RL', 'Standard Versus Distal Roux-en-Y Gastric Bypass with Similar Biliopancreatic Bowel Limb Lengths']","['weight loss, effect on obesity-related comorbid conditions, complications, re-operation rate, malnutrition rate, and re-admission rate', 'weight loss', 'Malabsorption requiring surgical bowel length adjustment', 'Weight loss']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1261315', 'cui_str': 'Limb length'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0024523', 'cui_str': 'Malabsorption syndrome'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]",444.0,0.0283902,"Significant lengthening of the RL at the cost of the common channel seems to have no effect on the weight loss at 1-year follow-up, which supports the theory that absorption of nutrients also occurs in the RL.","[{'ForeName': 'Ralph P M', 'Initials': 'RPM', 'LastName': 'Gadiot', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045, PM, Rotterdam, The Netherlands. ralph_gadiot@yahoo.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leeman', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045, PM, Rotterdam, The Netherlands.'}, {'ForeName': 'L Ulas', 'Initials': 'LU', 'LastName': 'Biter', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045, PM, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dunkelgrun', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045, PM, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Apers', 'Affiliation': 'Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045, PM, Rotterdam, The Netherlands.'}, {'ForeName': ""Gerhard Van't"", 'Initials': 'GV', 'LastName': 'Hof', 'Affiliation': 'Department of Bariatric Surgery, Bariatric Center South-West Netherlands, Bravis Hospital, Bergen op Zoom, The Netherlands.'}, {'ForeName': 'Pierre B', 'Initials': 'PB', 'LastName': 'Feskens', 'Affiliation': 'Department of Bariatric Surgery, Bariatric Center South-West Netherlands, Bravis Hospital, Bergen op Zoom, The Netherlands.'}, {'ForeName': 'Guido H', 'Initials': 'GH', 'LastName': 'Mannaerts', 'Affiliation': 'Department of Surgery, Tawam Hospital/ Johns Hopkins, Al Ain, Abu Dhabi, United Arab Emirates.'}]",Obesity surgery,['10.1007/s11695-020-04982-7']
2136,32955693,Reaching Out to Big Losers: How Different Types of Gamblers are Affected by a Brief Motivational Contact Initiated by the Gambling Provider.,"Telephone and letter-based motivational interventions with high expenditure gamblers have significant short and long term positive effects on gambling and use of responsible gambling tools. This report examines how different subtypes of gamblers, based upon patterns of play, are differentially affected. A randomized controlled trial design with three conditions (n = 1003 in each): feedback intervention by letter, telephone or a no-contact control condition. Subtypes of gamblers were derived by latent class analyses (LCA) based upon gambling behavior pre intervention. The participants were customers of Norsk Tipping gambling platforms. 1003 statistical triplets from the top 0.5% of customers based upon annual expenditure, matched on sex, age, and net losses. Primary outcome measure was gambling theoretical loss (TL), derived from the Norsk Tipping customer database. The LCA identified six subtypes: High Casino, High Sport, High Lottery, High Video lottery terminal (VLT), Lottery/Mix and Bingo/Casino. There were almost no differences in change in TL between the six subtypes of gamblers receiving the letter or telefone interventions respectively. However, the choice of contact by letter or telephone did have different effects for the different gambling subtypes. Sending a letter seems like a cost effective alternative to telephone contact for the High Lottery type, but telephone contact performs better for High Casino, High Sport and High VLT customers. Responsible gambling interventions can be improved by subtyping of gamblers.",2020,Telephone and letter-based motivational interventions with high expenditure gamblers have significant short and long term positive effects on gambling and use of responsible gambling tools.,['three conditions (n\u2009=\u20091003 in each'],"['feedback intervention by letter, telephone or a no-contact control condition', 'Telephone and letter-based motivational interventions']","['change in TL', 'gambling theoretical loss (TL), derived from the Norsk Tipping customer database']","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",1003.0,0.0453056,Telephone and letter-based motivational interventions with high expenditure gamblers have significant short and long term positive effects on gambling and use of responsible gambling tools.,"[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Jonsson', 'Affiliation': 'Department of Psychology, Stockholm University, 106 91, Stockholm, Sweden. jakob.jonsson@psychology.su.se.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hodgins', 'Affiliation': 'Department of Psychology, University of Calgary, 2500 University Dr NW, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Munck', 'Affiliation': 'Department of Education and Special Education, University of Gothenburg, P. O. Box 300, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, 106 91, Stockholm, Sweden.'}]",Journal of gambling studies,['10.1007/s10899-020-09978-7']
2137,32955694,"Feasibility, Acceptance, and Safety of Metacognitive Training for Problem and Pathological Gamblers (Gambling-MCT): A Pilot Study.","Approximately 90% of problem and pathological gamblers remain untreated. This treatment gap may be diminished by the implementation of low-threshold treatment programs. As cognitive distortions play a crucial role in the development and maintenance of gambling problems, interventions targeting gambling-related biases may be particularly effective. The aim of the present study was to examine the feasibility, acceptance, and safety of a novel metacognitive training for individuals with gambling problems (Gambling-MCT). Twenty-five participants were included in an uncontrolled pilot trial with two assessment points (intervention). The intervention comprised eight training modules targeting gambling-specific cognitive distortions. At baseline and post assessment, symptom severity, as measured with the PG-YBOCS, and gambling-related cognitive distortions, as measured with the GABS, were assessed. In addition, interim assessments measuring session-specific changes were conducted. Subjective appraisal was examined after each module and also post treatment. On average, participants took part in 4.16 (SD = 2.84) training sessions. Both intent-to-treat and per protocol analyses showed significant improvements on the PG-YBOCS and the GABS (d z  = 0.37-1.37). After Bonferroni correction for multiple testing, linear mixed models for the analysis of session-specific changes showed no deterioration in participants' mental state after any of the modules. Subjective appraisal of Gambling-MCT was good. The present pilot study provides first evidence for the feasibility, acceptance, and safety of Gambling-MCT. Recruitment of participants remains challenging, emphasizing the importance of overcoming patient-related treatment barriers. Future studies need to investigate the efficacy of Gambling-MCT in randomized controlled trials.",2020,Both intent-to-treat and per protocol analyses showed significant improvements on the PG-YBOCS and the GABS (d z  = 0.37-1.37).,"['Gambling-MCT', 'individuals with gambling problems (Gambling-MCT', 'Problem and Pathological Gamblers', 'Twenty-five participants were included in an uncontrolled pilot trial with two assessment points (intervention']","['novel metacognitive training', 'Metacognitive Training', 'eight training modules targeting gambling-specific cognitive distortions']","['symptom severity, as measured with the PG-YBOCS, and gambling-related cognitive distortions', 'PG-YBOCS and the GABS', 'Feasibility, Acceptance, and Safety', 'feasibility, acceptance, and safety']","[{'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0016910', 'cui_str': 'Gabon'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",25.0,0.106464,Both intent-to-treat and per protocol analyses showed significant improvements on the PG-YBOCS and the GABS (d z  = 0.37-1.37).,"[{'ForeName': 'Josefine', 'Initials': 'J', 'LastName': 'Gehlenborg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. j.gehlenborg@uke.de.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Bücker', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Berthold', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Miegel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}]",Journal of gambling studies,['10.1007/s10899-020-09975-w']
2138,32955714,Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial.,"BACKGROUND


The effectiveness of specialty medications in complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence.
OBJECTIVE


This study aims to determine whether pharmacist interventions improve specialty medication adherence.
METHODS


This is a single-center, pragmatic, randomized controlled trial ongoing since 10 May 2019 at an integrated health system specialty pharmacy. This study evaluates usual care compared with usual care plus patient-tailored adherence interventions. Study design and procedures were informed by focus groups with patients and specialty pharmacists. Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC) < 90% in the previous 4 months are identified by a daily query of the electronic pharmacy database. A pharmacist reviews these patients' electronic health records to identify and exclude ineligible patients. Eligible patients are randomized evenly to the control or intervention arm and stratified by historical clinic nonadherence rates. Patients randomized to the intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons. Interventions and follow-up are provided at the discretion of the intervening pharmacist. The primary outcome is PDC calculated at 8 months post-enrollment. Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum.
DISCUSSION


This trial will evaluate the effect of patient-tailored interventions on specialty medication adherence and will inform how often and why patients are misidentified as nonadherent.
REGISTRATION


The trial was deemed a quality improvement initiative by the Vanderbilt University Institutional Review Board. It was registered in ClinicalTrials.gov (NCT03709277) on 17 October 2018.",2020,"Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum.
","['10 May 2019 at an integrated health system specialty pharmacy', 'Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC)\u2009<\u200990% in the previous 4\xa0months are identified by a daily query of the electronic pharmacy database', 'Eligible patients', '438 participants']","['pharmacist interventions', 'intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons', 'patient-tailored interventions', 'usual care plus patient-tailored adherence interventions']","['Specialty Medication Adherence', 'PDC calculated', 'PDC']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",438.0,0.151243,"Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum.
","[{'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Kibbons', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA. Amanda.m.kibbons@vumc.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Peter', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'DeClercq', 'Affiliation': 'The Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Choi', 'Affiliation': 'The Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Jolly', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cherry', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Bassel', 'Initials': 'B', 'LastName': 'Alhashemi', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Nisha B', 'Initials': 'NB', 'LastName': 'Shah', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}, {'ForeName': 'Autumn D', 'Initials': 'AD', 'LastName': 'Zuckerman', 'Affiliation': 'Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, 726 Melrose Avenue, Nashville, TN, 37211, USA.'}]",Drugs - real world outcomes,['10.1007/s40801-020-00213-8']
2139,32955720,"Randomized Study of the Effects of Vitamin D and Magnesium Co-Supplementation on Muscle Strength and Function, Body Composition, and Inflammation in Vitamin D-Deficient Middle-Aged Women.","This study aimed to investigate the effects of vitamin D and magnesium co-supplementation on muscle strength and function, body composition, and inflammation in vitamin D-deficient middle-aged women. In this study, 83 healthy middle-aged women (40-55 years) with vitamin D deficiency were randomly assigned into two groups: (1) intervention: receiving a 50,000-IU vitamin D soft gel (weekly) plus a 250-mg magnesium tablet (daily); (2) control: receiving a vitamin D placebo (weekly) plus a magnesium placebo (daily), for 8 weeks. Before and after the intervention, anthropometric indices, muscle strength, muscle function, and some inflammatory markers were measured. After 8 weeks of supplementation, significant difference was observed in handgrip strength and time for Time Get Up and Go (TGUG) test between the intervention and placebo groups (P < 0.05). Regarding percentage of fat mass (FM%) and fat free mass (FFM%), and knee extension strength, there was no significant difference between the two groups at the end of intervention (P > .05). Serum 25(OH)-D levels increased significantly (P < 0.001) and its change was significantly different between the two groups, at the end of the intervention (P < 0.001). Serum level of hs-CRP decreased significantly in the intervention group compared to baseline (P < 0.001), and the change in hs-CRP was significant between the two groups at the end of the intervention (P < 0.01). Furthermore, serum level of TNF-α declined significantly in the intervention group compared to baseline (P < 0.001) but, no significant differences were seen between the two groups in regard of serum levels of TNF-α and IL-6 after the intervention (P > 0.05). Our findings show that vitamin D and magnesium co-supplementation, for 8 weeks, in healthy middle-aged women with vitamin D deficiency have beneficial impacts on muscle strength, muscle function, and probably inflammation.",2020,"Serum level of hs-CRP decreased significantly in the intervention group compared to baseline (P < 0.001), and the change in hs-CRP was significant between the two groups at the end of the intervention (P < 0.01).","['83 healthy middle-aged women (40-55 years) with vitamin D deficiency', 'healthy middle-aged women with vitamin D deficiency', 'Vitamin D-Deficient Middle-Aged Women', 'vitamin D-deficient middle-aged women']","['Vitamin D and Magnesium Co-Supplementation', 'placebo', 'vitamin D and magnesium co-supplementation', '50,000-IU vitamin D soft gel (weekly) plus a 250-mg magnesium tablet (daily); (2) control: receiving a vitamin D placebo (weekly) plus a magnesium placebo']","['muscle strength and function, body composition, and inflammation', 'anthropometric indices, muscle strength, muscle function, and some inflammatory markers', 'change in hs-CRP', 'serum levels of TNF-α and IL-6', 'Serum level of hs-CRP', 'serum level of TNF-α', 'Serum 25(OH)-D levels', 'Muscle Strength and Function, Body Composition, and Inflammation', 'handgrip strength and time for Time Get Up and Go', 'percentage of fat mass (FM%) and fat free mass (FFM%), and knee extension strength']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0310589', 'cui_str': 'Vitamin A- and vitamin D-containing product'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]",83.0,0.157574,"Serum level of hs-CRP decreased significantly in the intervention group compared to baseline (P < 0.001), and the change in hs-CRP was significant between the two groups at the end of the intervention (P < 0.01).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Kheyruri', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Sarrafzadeh', 'Affiliation': 'Department of Physical Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Agha Fatemeh', 'Initials': 'AF', 'LastName': 'Hosseini', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Department of Nutrition, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. vafa.m@iums.ac.ir.'}]",Biological trace element research,['10.1007/s12011-020-02387-2']
2140,32955752,The Adapted Resistance Training with Instability Randomized Controlled Trial for Gait Automaticity.,"BACKGROUND


Deficits in the cerebellar locomotor region (CLR) have been associated with loss of gait automaticity in individuals with freezing of gait in Parkinson's disease (freezers); however, exercise interventions that restore gait automaticity in freezers are lacking. We evaluated the effects of the adapted resistance training with instability ([ARTI] complex exercises) compared with traditional motor rehabilitation (without complex exercises) on gait automaticity and attentional set-shifting. We also verified associations between gait automaticity change and CLR activation change previously published.
METHODS


Freezers were randomized either to the experimental group (ARTI, n = 17) or to the active control group (traditional motor rehabilitation, n = 15). Both training groups performed exercises 3 times a week for 12 weeks. Gait automaticity (dual-task and dual-task cost [DTC] on gait speed and stride length), single-task gait speed and stride length, attentional set-shifting (time between Trail Making Test parts B and A), and CLR activation during a functional magnetic resonance imaging protocol of simulated step initiation task were evaluated before and after interventions.
RESULTS


Both training groups improved gait parameters in single task (P < 0.05), but ARTI was more effective than traditional motor rehabilitation in improving DTC on gait speed, DTC on stride length, dual-task stride length, and CLR activation (P < 0.05). Changes in CLR activation were associated with changes in DTC on stride length (r = 0.68, P = 0.002) following ARTI. Only ARTI improved attentional set-shifting at posttraining (P < 0.05).
CONCLUSIONS


ARTI restores gait automaticity and improves attentional set-shifting in freezers attributed to the usage of exercises with high motor complexity. © 2020 International Parkinson and Movement Disorder Society.",2020,"Both training groups improved gait parameters in single task (P < 0.05), but ARTI was more effective than traditional motor rehabilitation in improving DTC on gait speed, DTC on stride length, dual-task stride length, and CLR activation (P < 0.05).","[""individuals with freezing of gait in Parkinson's disease (freezers"", 'Freezers']","['adapted resistance training with instability ([ARTI] complex exercises', 'active control group (traditional motor rehabilitation', 'traditional motor rehabilitation (without complex exercises']","['stride length', 'gait speed and stride length), single-task gait speed and stride length, attentional set-shifting (time between Trail Making Test parts B and A), and CLR activation', 'gait speed, DTC on stride length, dual-task stride length, and CLR activation', 'CLR activation', 'gait automaticity and attentional set-shifting', 'gait automaticity change and CLR activation', 'Gait automaticity (dual-task and dual-task cost [DTC', 'gait parameters', 'attentional set-shifting']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175738', 'cui_str': 'Freezer'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0012194', 'cui_str': 'Dithiocarb'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0156028,"Both training groups improved gait parameters in single task (P < 0.05), but ARTI was more effective than traditional motor rehabilitation in improving DTC on gait speed, DTC on stride length, dual-task stride length, and CLR activation (P < 0.05).","[{'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Vieira-Yano', 'Affiliation': 'Exercise Neuroscience Research Group, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Douglas N', 'Initials': 'DN', 'LastName': 'Martini', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Fay B', 'Initials': 'FB', 'LastName': 'Horak', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, Oregon, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'de Lima-Pardini', 'Affiliation': ""Centre for Neuroscience Studies, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Almeida', 'Affiliation': 'Exercise Neuroscience Research Group, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Vagner P', 'Initials': 'VP', 'LastName': 'Santana', 'Affiliation': 'Exercise Neuroscience Research Group, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lima', 'Affiliation': 'Exercise Neuroscience Research Group, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Alana X', 'Initials': 'AX', 'LastName': 'Batista', 'Affiliation': 'Department of Radiology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Marquesini', 'Affiliation': 'Laboratory of Neuromuscular Adaptations to Strength Training, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jumes', 'Initials': 'J', 'LastName': 'Lira', 'Affiliation': 'Exercise Neuroscience Research Group, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, School of Medicine of the University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Corcos', 'Affiliation': 'Department of Physical Therapy and Human Movement Sciences, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ugrinowitsch', 'Affiliation': 'Laboratory of Neuromuscular Adaptations to Strength Training, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Silva-Batista', 'Affiliation': 'Exercise Neuroscience Research Group, University of Sao Paulo, Sao Paulo, Brazil.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28298']
2141,32955801,"Hydroxychloroquine for prophylaxis of COVID-19 physicians survey: Despite lack of evidence, many would take or give to dear ones, and despite the perceived necessity of an RCT, few would participate.","INTRODUCTION


There was no evidence concerning the prophylaxis with hydroxychloroquine, and only low-grade evidence regarding the use of hydroxychloroquine as a treatment for COVID-19 patients. We performed a survey among Romanian physicians in order to see how many of them would administer prophylactically hydroxychloroquine to themselves or to people close to them, and if they would participate to a randomized controlled trial.
METHODS


Between March 30 and April 02, 2020, a 16-item questionnaire was shared in a Romanian Facebook group of 2645 physicians dedicated to COVID-19 information, asking to be completed by physicians who could be directly involved in the care of these patients.
RESULTS


A total of 785 answers were collected. Nine physicians (1.1%) thought that there was clear evidence on prescribing hydroxychloroquine prophylaxis, 375 (48%) considered the evidence acceptable, 348 (44.3%) considered it weak, whereas 53 (6.8%) answered there was no evidence. 59 (7.5%) respondents were determined to take it (of which 31 = 4% already took), 192 (24.5%) were inclined to take, 271 (34.5%) were not decided yet. 175 (22.3%) of respondents declared they (would) give the treatment to their close ones, and this decision was associated with a higher age (P = 0.003), and the opinion that there was evidence (P < 0.001). When asked about the source of the treatment regimen, 286 (36.4%) indicated a scientific paper, while no scientific paper about the prophylaxis with hydroxychloroquine existed at that time. 718 (91.5%) considered a randomized clinical trial necessary (RCT), but only 333 (42.4%) answered they would enrol in such a trial. There was only a very weak correlation (Kendall's tau _b = 0.255, P < 0.001) between the belief that an RCT is necessary and the willingness to enrol in such an RCT.
CONCLUSIONS


Despite the lack of evidence, many physicians considered the evidence as existing, and were ready to take or to give hydroxychloroquine prophylactically to family. They considered an RCT necessary, but they were not willing to participate.",2020,"There was only a very weak correlation (Kendall's tau _b = 0.255, P < 0.001) between the belief that an RCT is necessary and the willingness to enrol in such an RCT","['Between March 30 and April 02, 2020, a 16-item questionnaire was shared in a Romanian Facebook group of 2645 physicians dedicated to COVID-19 information, asking to be completed by physicians who could be directly involved in the care of these patients', 'COVID-19 patients']","['RCT', 'hydroxychloroquine', 'Hydroxychloroquine']",[],"[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],785.0,0.0736841,"There was only a very weak correlation (Kendall's tau _b = 0.255, P < 0.001) between the belief that an RCT is necessary and the willingness to enrol in such an RCT","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Baicus', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Pinte', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Stoichitoiu', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Badea', 'Affiliation': 'Department of Internal Medicine, Colentina Hospital, Bucharest, Romania.'}]",Journal of evaluation in clinical practice,['10.1111/jep.13484']
2142,32950072,"Effect of aspirin on deaths associated with sepsis in healthy older people (ANTISEPSIS): a randomised, double-blind, placebo-controlled primary prevention trial.","BACKGROUND


Sepsis is a serious global health issue and a major cause of death and disability. The availability of a simple, community-based preventive strategy could substantially reduce the burden of sepsis. We aimed to establish whether low-dose aspirin reduced deaths or hospital admissions associated with sepsis in older people.
METHODS


ANTISEPSIS was a substudy of ASPREE (a randomised controlled primary prevention trial of low-dose aspirin [100 mg per day] compared with placebo in community dwelling older adults conducted in Australia and the USA), with the Australian cohort included in the ANTISEPSIS substudy. Inclusion criteria were participants aged at least 70 years who did not have major illnesses. Participants were block randomised (1:1) via a centralised web portal and stratified by general practice and age. Participants, investigators, and staff were masked to the intervention. Teams of clinical specialist investigators assessed potential sepsis events to establish if they satisfied the primary endpoint of death associated with sepsis. The analyses were by intention-to-treat with univariate survival analysis methods, the log-rank test, and Cox proportional hazards regression. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613000349741.
RESULTS


Between March 10, 2010, and Dec 24, 2014, of 20 288 individuals assessed for eligibility, 16 703 participants aged 70 years and older at trial entry were enrolled and followed up for a median of 4·6 years (IQR 3·6-5·6). 8322 (49·8%) participants were assigned to receive aspirin and 8381 (50·2%) to placebo. 203 deaths were considered to be associated with sepsis. Univariate analysis showed similar rates of death associated with sepsis in the two study groups (hazard ratio for aspirin vs placebo 1·08, 95% CI 0·82-1·43; p=0·57). Adverse events were previously reported in the ASPREE trial.
INTERPRETATION


Daily low-dose aspirin treatment did not reduce deaths associated with sepsis in community dwelling older adults. Our findings do not support the use of aspirin as a primary prevention strategy to reduce the burden of sepsis in this population.
FUNDING


National Health and Medical Research Council of Australia, National Institutes of Health, Monash University.",2020,"Univariate analysis showed similar rates of death associated with sepsis in the two study groups (hazard ratio for aspirin vs placebo 1·08, 95% CI 0·82-1·43; p=0·57).","['community dwelling older adults', 'Between March 10, 2010, and Dec 24, 2014, of 20\u2008288 individuals assessed for eligibility, 16\u2008703 participants aged 70 years and older at trial entry were enrolled and followed up for a median of 4·6 years (IQR 3·6-5·6', 'healthy older people (ANTISEPSIS', 'Inclusion criteria were participants aged at least 70 years who did not have major illnesses', 'community dwelling older adults conducted in Australia and the USA), with the Australian cohort included in the ANTISEPSIS substudy', 'deaths or hospital admissions associated with sepsis in older people']","['placebo', 'low-dose aspirin', 'aspirin']","['Adverse events', 'burden of sepsis']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003424', 'cui_str': 'Antisepsis'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]",16703.0,0.749059,"Univariate analysis showed similar rates of death associated with sepsis in the two study groups (hazard ratio for aspirin vs placebo 1·08, 95% CI 0·82-1·43; p=0·57).","[{'ForeName': 'Damon P', 'Initials': 'DP', 'LastName': 'Eisen', 'Affiliation': 'College of Medicine and Dentistry, James Cook University, Douglas, QLD, Australia; School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia. Electronic address: damon.eisen@jcu.edu.au.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Leder', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'McGuinness', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Department of Infectious Diseases, Alfred Health, Prahran, VIC, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pilcher', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Department of Intensive Care, Alfred Health, Prahran, VIC, Australia.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Moore', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Adithya', 'Initials': 'A', 'LastName': 'Shastry', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; The School of Public Health, Curtin University, Bentley, WA, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Emma S', 'Initials': 'ES', 'LastName': 'McBryde', 'Affiliation': 'Australian Institute of Tropical Health and Medicine, James Cook University, Douglas, QLD, Australia.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30411-2']
2143,32950113,Effects of training on knowledge and attitudes of coronary care unit nurses in relation to teamwork: A quasi-experimental study.,"Teamwork has special significance in patient safety and quality of care in the coronary care units (CCUs). This study aimed to determine the impact of training on attitudes and knowledge of CCU nurses about teamwork. This quasi-experimental study was conducted in the CCUs of Al-Zahra Cardiovascular Hospital, Shiraz, Iran. Participants included 70 nurses with a mean age of 31.33 ± 4.56 years. They were divided into experimental and control groups. Data were collected at the baseline and one month after an intervention using a teamwork knowledge test and Teamwork Attitude Questionnaire. The intervention involved a 4-hour workshop on teamwork. Data were analyzed via SPSS 16.0, using descriptive statistics, chi-square, paired t-test, and independent samples t-test. The mean overall teamwork attitude score of the experimental group following intervention (125.5 ± 12.56) had statistically significant differences from the baseline (110.4 ± 12.6) and the mean score of the control group (112.11 ± 15.17) (P < .001). Furthermore, the mean scores of attitude dimensions improved significantly, except for mutual support and situation monitoring. In addition, in relation to teamwork knowledge, the experimental group had a significantly higher mean score after the intervention (18.6 ± 4.35) compared with the baseline (13.14 ± 4.25) and the control group (14.8 ± 4.07) (P < .001). Training improved knowledge and attitudes of CCU nurses in relation to teamwork. Considering the critical role of mutual support and situation monitoring in nursing performance, we should place more emphasis on them in nursing education and practice. TRIAL REGISTRATION: IRCT2016080123199N2. Date registered 2016-09-22.",2020,The mean overall teamwork attitude score of the experimental group following intervention (125.5 ± 12.56) had statistically significant differences from the baseline (110.4 ± 12.6) and the mean score of the control group (112.11 ± 15.17) (P < .001).,"['coronary care unit nurses in relation to teamwork', 'Participants included 70 nurses with a mean age of 31.33\xa0±\xa04.56 years']",[],"['teamwork knowledge test and Teamwork Attitude Questionnaire', 'mean scores of attitude dimensions', 'mean overall teamwork attitude score', 'mean score', 'knowledge and attitudes', 'knowledge and attitudes of CCU nurses']","[{'cui': 'C0010066', 'cui_str': 'Coronary Care Units'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",70.0,0.0174262,The mean overall teamwork attitude score of the experimental group following intervention (125.5 ± 12.56) had statistically significant differences from the baseline (110.4 ± 12.6) and the mean score of the control group (112.11 ± 15.17) (P < .001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Khademian', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nejatali', 'Initials': 'N', 'LastName': 'Mohebi', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Khademian', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: khademianm@sums.ac.ir.'}]",Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing,['10.1016/j.jvn.2020.05.004']
2144,32950115,Effectiveness of a nurse-led physical activity intervention to decrease cardiovascular disease risk in middle-aged adults: A pilot randomized controlled study.,"The purpose of this study was to evaluate the effectiveness of the nurse-led physical activity (PA) intervention on cardiovascular disease (CVD) risk reduction in individuals with moderate risk. A randomized controlled pilot trial was conducted with 12 individuals who have moderate cardiovascular risk meeting the inclusion criteria. Eleven individuals in the intervention group participated in a 12-week PA program (outdoor group walking with the group 5 days in a week, each lasting for 40 minutes) guided by a nurse. For determining the risk level of CVD, the ""HeartScore program"" was used. Height, weight, blood pressure, and cholesterol values of individuals in the intervention group were measured. At the end of nurse-led outdoor walking activity with the group for 12 weeks, systolic blood pressure (P = .041) and cholesterol (P = .001) values of individuals in the intervention group decreased based on the baseline levels and accordingly CVD risk levels decreased significantly (P = .019). There was no significant difference in the control group. This study demonstrates that health care professionals working in the family health centers can easily determine the CVD risk with the HeartScore. Outdoor group walking program guided by a nurse is effective in decreasing the CVD risk level.",2020,There was no significant difference in the control group.,"['individuals with moderate risk', 'middle-aged adults', '12 individuals who have moderate cardiovascular risk meeting the inclusion criteria']","['nurse-led physical activity intervention', 'nurse-led physical activity (PA) intervention', 'PA program (outdoor group walking with the group 5\xa0days in a week, each lasting for 40\xa0minutes) guided by a nurse']","['outdoor walking activity', 'CVD risk level', 'cardiovascular disease risk', 'CVD risk levels', 'systolic blood pressure', 'Height, weight, blood pressure, and cholesterol values', 'cardiovascular disease (CVD) risk reduction', 'cholesterol']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.0253268,There was no significant difference in the control group.,"[{'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Dağistan Akgöz', 'Affiliation': 'Faculty of Nursing, Akdeniz University, Antalya, Turkey. Electronic address: aysedagistan@akdeniz.edu.tr.'}, {'ForeName': 'Sebahat', 'Initials': 'S', 'LastName': 'Gözüm', 'Affiliation': 'Faculty of Nursing, Akdeniz University, Antalya, Turkey.'}]",Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing,['10.1016/j.jvn.2020.05.002']
2145,32950246,Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial.,"BACKGROUND


The majority of postoperative patients report moderate to severe pain, possibly related to opioid underdosing or overdosing during surgery. Objective guidance of opioid dosing using the Nociception Level (NOL) index, a multiparameter artificial intelligence-driven index designed to monitor nociception during surgery, may lead to a more appropriate analgesic regimen, with effects beyond surgery. We tested whether NOL-guided opioid dosing during general anaesthesia results in less postoperative pain.
METHODS


In this two-centre RCT, 50 patients undergoing abdominal surgery under fentanyl/sevoflurane anaesthesia were randomised to NOL-guided fentanyl dosing or standard care in which fentanyl dosing was based on haemodynamics. The primary endpoint of the study was postoperative pain assessed in the PACU.
RESULTS


Median postoperative pain scores were 3.2 (inter-quartile range 1.3-4.3) and 4.8 (3.0-5.3) in NOL-guided and standard care groups, respectively (P=0.006). Postoperative morphine consumption (standard deviation) was 0.06 (0.07) mg kg -1  (NOL-guided group) and 0.09 (0.09) mg kg -1  (control group; P=0.204). During surgery, fentanyl dosing was not different between groups (NOL-guided group: 6.4 [4.2] μg kg -1 vs standard care: 6.0 [2.2] μg kg -1 , P=0.749), although the variation between patients was greater in the NOL-guided group (% coefficient of variation 66% in the NOL-guided group vs 37% in the standard care group).
CONCLUSIONS


Despite absence of differences in fentanyl and morphine consumption during and after surgery, a 1.6-point improvement in postoperative pain scores was observed in the NOL-guided group. We attribute this to NOL-driven rather than BP- and HR-driven fentanyl dosing during anaesthesia.
CLINICAL TRIAL REGISTRATION


www.trialregister.nl under identifier NL7845.",2020,"During surgery, fentanyl dosing was not different between groups (NOL-guided group: 6.4 [4.2] μg kg -1 vs standard care: 6.0 [2.2] μg kg -1 , P=0.749), although the variation between patients was greater in the NOL-guided group (% coefficient of variation 66% in the NOL-guided group vs 37% in the standard care group).
",['50 patients undergoing abdominal surgery under fentanyl/sevoflurane anaesthesia'],"['sevoflurane anaesthesia', 'NOL-guided fentanyl dosing or standard care in which fentanyl', 'NOL-guided opioid']","['Postoperative morphine consumption (standard deviation', 'Nociception Level (NOL) index', 'postoperative pain assessed in the PACU', 'Median postoperative pain scores', 'postoperative pain scores', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.125131,"During surgery, fentanyl dosing was not different between groups (NOL-guided group: 6.4 [4.2] μg kg -1 vs standard care: 6.0 [2.2] μg kg -1 , P=0.749), although the variation between patients was greater in the NOL-guided group (% coefficient of variation 66% in the NOL-guided group vs 37% in the standard care group).
","[{'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Meijer', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Honing', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Roor', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands; Department of Anesthesiology, Alrijne Hospital, Leiderdorp, Netherlands.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Toet', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands; Department of Anesthesiology, Alrijne Hospital, Leiderdorp, Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Calis', 'Affiliation': 'Department of Anesthesiology, Alrijne Hospital, Leiderdorp, Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Olofsen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Martini', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'van Velzen', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Aarts', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Niesters', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Boon', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Dahan', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands. Electronic address: a.dahan@lumc.nl.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.07.057']
2146,32950295,"Reply to Alireza Ghoreifi and Hooman Djaladat's Letter to the Editor re: Fredrik Liedberg, Petter Kollberg, Marie Allerbo, et al. Preventing Parastomal Hernia After Ileal Conduit by the Use of a Prophylactic Mesh: A Randomised Study. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.07.033.",,2020,,[],[],['Parastomal Hernia'],[],[],"[{'cui': 'C0341539', 'cui_str': 'Parastomal hernia'}]",,0.0188002,,"[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Liedberg', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden. Electronic address: fredrik.liedberg@med.lu.se.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Kollberg', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden; Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Allerbo', 'Affiliation': 'Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Gediminas', 'Initials': 'G', 'LastName': 'Baseckas', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Brändstedt', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Sigurdur', 'Initials': 'S', 'LastName': 'Gudjonsson', 'Affiliation': 'Department of Urology, Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Hagberg', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Regional Cancer Centre South, Lund, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Håkansson', 'Affiliation': 'Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jerlström', 'Affiliation': 'Department of Urology, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Annica', 'Initials': 'A', 'LastName': 'Löfgren', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Patschan', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sörenby', 'Affiliation': 'Institute of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Bläckberg', 'Affiliation': 'Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}]",European urology,['10.1016/j.eururo.2020.09.025']
2147,32950330,The effect of a shelf placement intervention on sales of healthier and less healthy breakfast cereals in supermarkets: A co-designed pilot study.,"Supermarkets are the principal source of grocery food in many high-income countries. Choice architecture strategies show promise to improve the healthiness of food choices. A retailer-academic collaboration was formed to co-design and pilot selected commercially sustainable strategies to increase sales of healthier foods relative to less healthy foods in supermarkets. Two co-design workshops, involving supermarket corporate staff and public health nutrition academics, identified potential interventions. One intervention, more prominent shelf placement of healthier products within one category (breakfast cereals), was selected for testing. A pilot study (baseline, intervention and follow-up, 12-weeks each) was undertaken in six supermarkets (three intervention and three control) in Auckland, New Zealand. Products were ranked by nutrient levels and profile, and after accounting for the supermarkets' space management principles, healthier products were placed at adult eye level. The primary outcome was change in sales of healthier products relative to total category sales. Secondary outcomes were nutrient profile of category sales, in-store product promotions, customer perceptions, and retailer feedback. There was no difference in proportional sales of more prominently positioned healthier products between intervention (56%) and control (56%) stores during the intervention. There were no differences in the nutrient profile of category sales. A higher proportion of less healthy breakfast cereals were displayed in intervention versus control stores (57% vs 43%). Most customers surveyed supported shelf placement as a strategy (265, 88%) but noted brand preferences and price were more salient determinants of purchases. Retailers were similarly supportive but balancing profit, health/nutrition and customer satisfaction was challenging. Shelf placement alone was not an effective strategy to increase purchases of healthier breakfast cereals. This study showed co-design of a healthy eating intervention with a commercial retailer is feasible, but concurrent retail environment factors likely limited the public health impact of the intervention.",2020,There was no difference in proportional sales of more prominently positioned healthier products between intervention (56%) and control (56%) stores during the intervention.,['sales of healthier and less healthy breakfast cereals in supermarkets'],"['healthy eating intervention', 'shelf placement intervention']","['nutrient profile of category sales', 'change in sales of healthier products relative to total category sales', 'nutrient profile of category sales, in-store product promotions, customer perceptions, and retailer feedback', 'healthy breakfast cereals', 'proportional sales']","[{'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}]",,0.0487893,There was no difference in proportional sales of more prominently positioned healthier products between intervention (56%) and control (56%) stores during the intervention.,"[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. Electronic address: leanne.young@auckland.ac.nz.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Rosin', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Grey', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Vandevijvere', 'Affiliation': 'Scientific Institute of Public Health (Sciensano), Rue Juliette Wytsmanstraat 14, 1050, Brussels, Belgium.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Waterlander', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Public Health, P.O. Box 19268, 1000, GG Amsterdam, the Netherlands.'}, {'ForeName': 'Cliona', 'Initials': 'C', 'LastName': 'Ni Mhurchu', 'Affiliation': 'National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113337']
2148,32936981,A pilot randomized trial of an educational intervention to increase genetic counseling and genetic testing among Latina breast cancer survivors.,"Latinas are less likely to participate in genetic counseling (GC) and genetic testing (GT) than non-Hispanic Whites. A multisite, randomized pilot study tested a culturally targeted educational intervention to increase uptake of GC/GT among Latina breast cancer (BC) survivors (N = 52). Participants were recruited in Tampa, FL and Ponce, PR and randomized to: (a) fact sheet about BC survivorship (control) or (b) a culturally targeted educational booklet about GC/GT (intervention). Participants in the intervention condition were also offered no-cost telephone GC followed by free GT with mail-based saliva sample collection. Participants self-reported hereditary breast and ovarian cancer (HBOC) knowledge and emotional distress at baseline and 1- and 3-month follow-ups. We used logistic regression to examine differences in GC/GT uptake by study arm (primary outcome) and repeated measures ANOVA to examine the effects of study arm and time on HBOC knowledge and emotional distress (secondary outcomes). Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention   = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention   = 12.93, 95% CI = 2.82-59.20, p < .01). Study site did not predict uptake of GC (p = .08) but Ponce participants were more likely to complete GT (OR Ponce   = 4.53, 95% CI = 1.04-19.72, p = .04). ANOVAs demonstrated an increase in HBOC knowledge over time across both groups (F(2,88) = 12.24, p < .01, η p   2   = 0.22). We also found a significant interaction of study arm and time, such that intervention participants demonstrated a greater and sustained (to the 3-month follow-up) increase in knowledge than control participants (F(2,88) = 3.66, p = .03, η p   2   = 0.08). No other main or interaction effects were significant (all p's> .15). Study findings demonstrate the potential of our culturally targeted print intervention. Lessons learned from this multisite pilot study for enhancing GC/GT in Latinas include the need to attend to both access to GC/GT and individual factors such as attitudes and knowledge.",2020,"Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention   = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention   = 12.93, 95% CI = 2.82-59.20, p < .01).","['Latina breast cancer (BC) survivors (N\xa0=\xa052', 'Latina breast cancer survivors']","['culturally targeted educational intervention', 'fact sheet about BC survivorship (control) or (b) a culturally targeted educational booklet about GC/GT (intervention', 'educational intervention']","['hereditary breast and ovarian cancer (HBOC) knowledge and emotional distress', 'HBOC knowledge', 'HBOC knowledge and emotional distress']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}]","[{'cui': 'C0677776', 'cui_str': 'Hereditary breast and ovarian cancer syndrome'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",,0.0506475,"Compared to the control arm, intervention participants were more likely to complete GC (OR Intervention   = 13.92, 95% CI = 3.06-63.25, p < .01) and GT (OR Intervention   = 12.93, 95% CI = 2.82-59.20, p < .01).","[{'ForeName': 'Claire C', 'Initials': 'CC', 'LastName': 'Conley', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Eida M', 'Initials': 'EM', 'LastName': 'Castro-Figueroa', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moreno', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dutil', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'García', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Burgos', 'Affiliation': 'Ponce Health Sciences University, Ponce, PR, USA.'}, {'ForeName': 'Charité', 'Initials': 'C', 'LastName': 'Ricker', 'Affiliation': 'University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Jongphil', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Kristi D', 'Initials': 'KD', 'LastName': 'Graves', 'Affiliation': 'Georgetown Lombardi Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Kimlin Tam', 'Initials': 'KT', 'LastName': 'Ashing', 'Affiliation': 'City of Hope Medical Center, Duarte, CA, USA.'}, {'ForeName': 'Gwendolyn P', 'Initials': 'GP', 'LastName': 'Quinn', 'Affiliation': 'New York University, Grossman School of Medicine New York, New York, NY, USA.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Soliman', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Vadaparampil', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1324']
2149,32938496,Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


In some patients, acute, life-threatening respiratory injury produced by viruses such as SARS-CoV and other viral pneumonia are associated with an over-exuberant cytokine release. Elevated levels of blood IL-6 had been identified as a one of the risk factors associated with severe COVID-19 disease. Anti-IL6 inhibitors are among the therapeutic armamentarium for preventing the fatal consequences of acute respiratory and multi organ failure in around 20% of the COVID-19 infected patients. At present, their use is prioritized to patients with severe interstitial pneumonia (Brescia-COVID Scale-COVID 2-3) with hyperinflammation as determined by the presence of elevated IL6 and/or d-dimer, or progressive d-dimer increase, in patients who otherwise are subsidiary to ICU admission. However, many uncertainties remain on the actual role of anti-IL6 inhibitors in this setting, and whether current use and timing is the right one. There is the hypothesis that the use of anti-IL6 inhibitors at an earlier state during the hyperinflammatory syndrome would be beneficial and may avoid progressing to ARDS. On the other hand, the standard of care has changed and nowadays the use of corticosteroids has become part of the SOC in the treatment of COVID-19 pneumonia. Our limited experience suggests that better treatment outcomes can be achieved when combining IL6-inhibitors (e.g. sarilumab) with corticosteroids. The aim of the present study is to evaluate if an earlier therapeutic intervention with sarilumab plus SOC (including corticosteroids) may be more effective than current standard of care alone, in preventing progression to respiratory failure in COVID-19 infected patients with interstitial pneumonia. This study will also provide supportive evidence to that provided by currently ongoing studies on the efficacy and safety of sarilumab in this clinical context.
TRIAL DESIGN


A phase two multi-center randomised controlled trial (RCT) with two parallel arms (1:1 ratio).
PARTICIPANTS


They will be hospitalized patients, of at least 18 years of age, with severe COVID-19 who have positive RT-PCR test and have radiographic evidence of pulmonary infiltrates by imaging or rales/crackles on exam and SpO2 ≤ 94% on room air that requires supplemental oxygen. Patients must present elevation of inflammatory parameters (IL-6 > 40 pg/mL or d-dimer >1.0 mcg/ml) or, alternatively, progressive worsening in at least two of these inflammatory parameters in the prior 24-48h: CRP, LDH, serum ferritin, lymphopenia, or d-dimer.
EXCLUSION CRITERIA


high oxygen requirements (including face mask with reservoir, non-invasive mechanical ventilation or high flow nasal cannula, or mechanical ventilation), admission to ICU, pregnancy or lactation, allergy or hypersensitivity to sarilumab or corticoesteroids, immunosuppressive antibody therapy within the past 5 months, AST/ALT values > 10 x ULN, neutropenia (< 0.5 x 109/L), severe thrombocytopenia (< 50 x 109/L), sepsis caused by an alternative pathogen, diverticulitis with risk of perforation or ongoing infectious dermatitis. The study will be conducted in several hospitals in Spain.
INTERVENTION AND COMPARATOR


Patients randomised to the experimental arm will receive sarilumab + methylprednisolone plus SOC for COVID-19. Patients included in the control arm will receive methylprednisolone plus SOC for COVID-19. Corticosteroids will be given to all patients at a 1mg/kg/d of methylprednisolone for at least 3 days. Clinical follow-up visits will be performed at 3, 5, and 15 days after treatment randomization. Patients in the control group (SOC group without sarilumab) progressing to Brescia- COVID 2-3 plus inflammatory markers, will be given the option to be rescued with sarilumab at the same doses and, in that case, be included in an open-label phase and be followed up for additional weeks (with visits at 3, 7 and 15 days after sarilumab rescue administration). Patients randomly assigned to sarilumab therapy at baseline progressing to Brescia-COVID 2-3 will be rescued according to local clinical practice protocols. A final follow-up visit will be conducted for all patients at day 29 from randomization, regardless of initial treatment assignment.
MAIN OUTCOMES


Primary end point is the proportion of patients progressing to either severe respiratory failure (Brescia-COVID ≥2), ICU admission, or death.
RANDOMIZATION


Randomization codes were produced by means of the PROC PLAN of the SAS system, with a 1:1 assignment ratio, stratifying by centre and using blocks multiple of 2 elements. The randomization schedule will be managed through the eCRF in a concealed manner.
BLINDING (MASKING)


All study drugs will be administered as open label. No blinding methods will be used in this trial.
NUMBERS TO BE RANDOMISED (SIMPLE SIZE)


The target sample size will be 200 COVID-19 patients, who will be allocated randomly to control arm (100) and treatment arm (100).
TRIAL STATUS


Protocol Code: SARTRE Protocol Date: May 05th 2020. Version: 2.0 The study has been approved by the Spanish Competent Authority (AEMPS) as a low intervention clinical trial. Start of recruitment: August, 2020 End of recruitment: May, 2021 TRIAL REGISTRATION: Identifier: EudraCT Number: 2020-002037-15 ; Registration date: 26 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"A final follow-up visit will be conducted for all patients at day 29 from randomization, regardless of initial treatment assignment.
","['Identifier: EudraCT Number: 2020-002037-15 ; Registration date: 26 May 2020', 'hospitalized patients', ' 50 x 109/L), sepsis caused by an alternative pathogen, diverticulitis with risk of perforation or ongoing infectious dermatitis', 'They will be hospitalized patients, of at least 18 years of age, with severe COVID-19 who have positive RT-PCR test and have radiographic evidence of pulmonary infiltrates by imaging or rales/crackles on exam and SpO2 ≤ 94% on room air that requires supplemental oxygen', '200 COVID-19 patients', 'several hospitals in Spain', 'COVID-19 infected patients with interstitial pneumonia', '2020 End of recruitment']","['sarilumab plus SOC (including corticosteroids', 'sarilumab therapy', 'methylprednisolone', 'Sarilumab versus standard of care', 'sarilumab + methylprednisolone plus SOC for COVID-19', 'Corticosteroids', 'methylprednisolone plus SOC']","['severe thrombocytopenia', 'admission to ICU, pregnancy or lactation, allergy or hypersensitivity to sarilumab or corticoesteroids, immunosuppressive antibody therapy', 'Elevated levels of blood IL-6', 'proportion of patients progressing to either severe respiratory failure (Brescia-COVID ≥2), ICU admission, or death']","[{'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0034642', 'cui_str': 'Respiratory crackles'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0206061', 'cui_str': 'Interstitial pneumonia'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]","[{'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",200.0,0.169355,"A final follow-up visit will be conducted for all patients at day 29 from randomization, regardless of initial treatment assignment.
","[{'ForeName': 'Antonio F', 'Initials': 'AF', 'LastName': 'Caballero Bermejo', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Ruiz-Antorán', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain. mariabelen.ruiz@salud.madrid.org.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fernández Cruz', 'Affiliation': 'Infectious Diseases Unit, Internal Medicine Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Diago Sempere', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Callejas Díaz', 'Affiliation': 'Infectious Diseases Unit, Internal Medicine Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Múñez Rubio', 'Affiliation': 'Infectious Diseases Unit, Internal Medicine Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Avendaño-Solá', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ramos Martínez', 'Affiliation': 'Infectious Diseases Unit, Internal Medicine Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': 'Aránzazu', 'Initials': 'A', 'LastName': 'Sancho López', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro - Segovia de Arana, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04633-3']
2150,32942245,Evaluation of the symptom-focused health assessment and empathy program for undergraduate nursing students: A randomized controlled trial.,"BACKGROUND


Health assessments are a vital competency required of nurses. The more traditional ways of teaching and learning this skill require practice and are often limited by time constraints. With the rise of technology-based platforms, students can supplement their learning health assessment skills through other means, such as videos, that not only teach the steps but also allow them to learn in context.
OBJECTIVES


This study describes how a symptom-focused health assessment and empathy (SHAE) program, which primarily involves the use of a case-based health assessment video, was implemented and evaluated.
DESIGN


The study involved a single-centre, single-blind, parallel randomized controlled trial.
SETTINGS


The study was conducted at a university in Singapore.
PARTICIPANTS


Year one undergraduate nursing students enrolled in the Comprehensive Health Assessment (CHA) module during semester two of the academic year 2018/2019 participated in the study.
METHODS


Participants were randomized into one of the two parallel groups: the experimental group or the waitlisted control (WL) group. The experimental group received the SHAE program in addition to conventional learning methods (e-lectures, lab demonstration, and pair practice). The WL group received only the conventional learning methods. Pre- and post-test measures of the study variables such as knowledge, health assessment skills, confidence, empathy, and intention to learn were conducted. The WL group was given access to the SHAE program after the post-test. Analyses of covariance (ANCOVA) were used to compare the means of the study variables between the intervention and WL groups.
RESULTS


Participants in the intervention group had significantly higher scores on knowledge (p = 0.016), confidence (p = 0.03), and health assessment skills (p = 0.004). No significant differences in intention to learn and empathy between the two groups were found.
CONCLUSION


The use of a case-based video has the potential to be a valuable method of teaching health assessments in context to nursing students. The SHAE program has shown beneficial effects on students' knowledge, health assessment skills, and confidence. However, there was no effect on students' intentions to learn and their empathy. Further refinements of the program will need to focus on improving these domains.",2020,"RESULTS


Participants in the intervention group had significantly higher scores on knowledge (p = 0.016), confidence (p = 0.03), and health assessment skills (p = 0.004).","['Participants', 'university in Singapore', 'Year one undergraduate nursing students enrolled in the Comprehensive Health Assessment (CHA) module during semester two of the academic year 2018/2019 participated in the study', 'undergraduate nursing students']","['conventional learning methods', 'SHAE program', 'symptom-focused health assessment and empathy program', 'waitlisted control (WL']","['knowledge', 'knowledge, health assessment skills, confidence, empathy, and intention to learn', 'health assessment skills', 'intention to learn and empathy', ""students' intentions to learn and their empathy""]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",,0.0319629,"RESULTS


Participants in the intervention group had significantly higher scores on knowledge (p = 0.016), confidence (p = 0.03), and health assessment skills (p = 0.004).","[{'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, 117597, Singapore. Electronic address: nurch@nus.edu.sg.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Ignacio', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, 117597, Singapore. Electronic address: nurimjj@nus.edu.sg.'}, {'ForeName': 'Piyanee', 'Initials': 'P', 'LastName': 'Yobas', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Level 2, Clinical Research Centre, Block MD11, 10 Medical Drive, 117597, Singapore. Electronic address: nurpk@nus.edu.sg.'}]",Nurse education today,['10.1016/j.nedt.2020.104566']
2151,32946086,Management of thoracolumbar injury classification and severity score of 4 (TLICS=4) thoracolumbar vertebra fractures: Surgery versus conservative treatment.,"BACKGROUND


This study aims to compare clinical and radiographic outcomes of surgical treatment and conservative treatment with bracing in neurologically intact patients with score 4 of TLICS thoracolumbar vertebra fractures.
METHODS


Patients with traumatic thoracolumbar junction fractures (T11-L2), the score of TLICS 4, and minimum 24-month follow-up were included in this study. Patients were divided into surgery and bracing groups. The groups were compared concerning clinical and demographical features, local kyphotic angles (LKA), vertebra height loss percentage (VHL), Oswestry Disability Index (ODI), Visual Analog Scale (VAS) and time to return to work.
RESULTS


There were 74 patients (71 males, 3 females) in the surgery group and 76 patients (58 males, 18 females) in the bracing group. Although the surgery group showed better improvement in VAS scores within six months postoperatively, no significant difference was observed at the 24th-month evaluation (p<0.001 and p=0.270, respectively). ODI, LKA and VHL were significantly lower in the surgery group (p<0.001, p<0.001 and p<0.001, respectively). In addition, return to work was significantly earlier in the surgery group (p<0.001).
CONCLUSION


The findings obtained in this study suggest that the surgical treatment for TLICS 4 patients with thoracolumbar fractures has better clinical and radiographic outcomes than the bracing. Moreover, returning time to the work of patients is shortened with surgical treatment. The surgical treatment seems to be the first and the appropriate choice in the management of TLICS 4 thoracolumbar vertebral fractures.",2020,"ODI, LKA and VHL were significantly lower in the surgery group (p<0.001, p<0.001 and p<0.001, respectively).","['74 patients (71 males, 3 females) in the surgery group and 76 patients (58 males, 18 females) in the bracing group', 'neurologically intact patients with score 4 of TLICS thoracolumbar vertebra fractures', 'Patients with traumatic thoracolumbar junction fractures (T11-L2), the score of TLICS 4, and minimum 24-month follow-up were included in this study']",[],"['ODI, LKA and VHL', 'clinical and demographical features, local kyphotic angles (LKA), vertebra height loss percentage (VHL), Oswestry Disability Index (ODI), Visual Analog Scale (VAS) and time to return to work', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0424641', 'cui_str': 'Decrease in height'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",4.0,0.0245825,"ODI, LKA and VHL were significantly lower in the surgery group (p<0.001, p<0.001 and p<0.001, respectively).","[{'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Karaali', 'Affiliation': 'Department of Orthopedics and Traumatology, Adana City Hospital, Adana-Turkey.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Ciloglu', 'Affiliation': 'Department of Orthopedics and Traumatology, Adana City Hospital, Adana-Turkey.'}, {'ForeName': 'Altuğ', 'Initials': 'A', 'LastName': 'Duramaz', 'Affiliation': 'Department of Orthopedics and Traumatology, Bakırköy Dr. Sadi Konuk Training and Research Hospital, İstanbul-Turkey.'}, {'ForeName': 'Aslihan', 'Initials': 'A', 'LastName': 'Kusvuran Ozkan', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Özülkü Medical Center, Adana-Turkey.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Ekiz', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, İstanbul Gedik University Faculty of Health Sciences, İstanbul-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2020.30524']
2152,32942043,Rationale and design of the Medical Research Council's Precision Medicine with Zibotentan in Microvascular Angina (PRIZE) trial.,"Microvascular angina is caused by cardiac small vessel disease, and dysregulation of the endothelin system is implicated. The minor G allele of the non-coding single nucleotide polymorphism (SNP) rs9349379 enhances expression of the endothelin 1 gene in human vascular cells, increasing circulating concentrations of ET-1. The prevalence of this allele is higher in patients with ischemic heart disease. Zibotentan is a potent, selective inhibitor of the ET A  receptor. We have identified zibotentan as a potential disease-modifying therapy for patients with microvascular angina. METHODS: We will assess the efficacy and safety of adjunctive treatment with oral zibotentan (10 mg daily) in patients with microvascular angina and assess whether rs9349379 (minor G allele; population prevalence ~36%) acts as a theragnostic biomarker of the response to treatment with zibotentan. The PRIZE trial is a prospective, randomized, double-blind, placebo-controlled, sequential cross-over trial. The study population will be enriched to ensure a G-allele frequency of 50% for the rs9349379 SNP. The participants will receive a single-blind placebo run-in followed by treatment with either 10 mg of zibotentan daily for 12 weeks then placebo for 12 weeks, or vice versa, in random order. The primary outcome is treadmill exercise duration using the Bruce protocol. The primary analysis will assess the within-subject difference in exercise duration following treatment with zibotentan versus placebo. CONCLUSION: PRIZE invokes precision medicine in microvascular angina. Should our hypotheses be confirmed, this developmental trial will inform the rationale and design for undertaking a larger multicenter trial.",2020,"The minor G allele of the non-coding single nucleotide polymorphism (SNP) rs9349379 enhances expression of the endothelin 1 gene in human vascular cells, increasing circulating concentrations of ET-1.","['patients with microvascular angina', 'microvascular angina', 'patients with ischemic heart disease', 'patients with microvascular angina and assess whether rs9349379 (minor G allele; population prevalence ~36']","['placebo', 'oral zibotentan', 'zibotentan versus placebo']","['exercise duration', 'efficacy and safety', 'treadmill exercise duration using the Bruce protocol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206064', 'cui_str': 'Cardiac syndrome X'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0442713', 'cui_str': 'Bruce protocol'}]",,0.469459,"The minor G allele of the non-coding single nucleotide polymorphism (SNP) rs9349379 enhances expression of the endothelin 1 gene in human vascular cells, increasing circulating concentrations of ET-1.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Morrow', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ford', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom; University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mangion', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Kotecha', 'Affiliation': 'Royal Free Hospital, Royal Free London NHS Foundation Trust London, United Kingdom.'}, {'ForeName': 'Roby', 'Initials': 'R', 'LastName': 'Rakhit', 'Affiliation': 'Royal Free Hospital, Royal Free London NHS Foundation Trust London, United Kingdom.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Galasko', 'Affiliation': 'Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hoole', 'Affiliation': 'Department of Interventional Cardiology, Royal Papworth Hospital, Cambridge, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Davenport', 'Affiliation': 'Experimental Medicine and Immunotherapeutics, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kharbanda', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, British Heart Foundation Centre of Research Excellence, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom; Department of Cardiology, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Ferreira', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, British Heart Foundation Centre of Research Excellence, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Mayooran', 'Initials': 'M', 'LastName': 'Shanmuganathan', 'Affiliation': 'Division of Cardiovascular Medicine, Radcliffe Department of Medicine, British Heart Foundation Centre of Research Excellence, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Chiribiri', 'Affiliation': ""Division of Imaging Sciences, Guy's and St Thomas' Hospital NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Divaka', 'Initials': 'D', 'LastName': 'Perera', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Haseeb', 'Initials': 'H', 'LastName': 'Rahman', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Jayanth R', 'Initials': 'JR', 'LastName': 'Arnold', 'Affiliation': 'Department of Cardiovascular Sciences, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds University and Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Liverpool University and Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Husmeier', 'Affiliation': 'School of Mathematics & Statistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Hill', 'Affiliation': 'School of Mathematics & Statistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'School of Mathematics & Statistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Department of Clinical Genetics, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'Department of Clinical Genetics, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Dempster', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Macfarlane', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Whittaker', 'Affiliation': 'Emerging Innovations Unit, Discovery Sciences, R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Alex Mc', 'Initials': 'AM', 'LastName': 'Connachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Sandosh', 'Initials': 'S', 'LastName': 'Padmanabhan', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom. Electronic address: colin.berry@glasgow.ac.uk.'}]",American heart journal,['10.1016/j.ahj.2020.07.007']
2153,32942054,Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention.,"BACKGROUND


Successful methods for scaling-up evidence-based programs are needed to prevent skin cancer among adults who work outdoors in the sun.
METHODS


A randomized trial is being conducted comparing two methods of scaling-up the Sun Safe Workplaces (SSW) intervention. Departments of transportation (DOTs) from 21 U.S. states are participating and their 138 regional districts were randomized following baseline assessment. In districts assigned to the in-person method (n = 46), project staff meets personally with managers, conducts trainings for employees, and provides printed materials. In districts assigned to the digital method (n = 92), project staff conduct these same activities virtually, using conferencing technology, online training, and electronic materials. Delivery of SSW in both groups was tailored to managers' readiness to adopt occupational sun safety. Posttesting will assess manager's support for and use of SSW and employees' sun safety. An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
RESULTS


The state DOTs range in size from 997 to 18,415 employees. At baseline, 1113 managers (49.0%) completed the pretest (91.5% male, 91.1% white, 19.77 years on the job, 66.5% worked outdoors; and 24.4% had high-risk skin types). They were generally supportive of occupational sun safety. A minority reported that the employer had a written policy, half reported training, and two-thirds, messaging on sun protection.
CONCLUSIONS


Digital methods are available that may make scale-up of SSW cost-effective in a national distribution to nearly half of the state DOTs.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03278340.",2020,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","['Departments of transportation (DOTs) from 21\u202fU.S. states are participating and their 138 regional districts', 'adults who work outdoors in the sun']","['scaling-up the Sun Safe Workplaces (SSW) intervention', 'scaling-up an occupational sun protection intervention']",[],"[{'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}]",[],,0.139656,"An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method.
","[{'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Research at Klein Buendel, Inc, A Health Communication and Media Development Firm, Golden, CO, USA. Electronic address: dbuller@kleinbuendel.com.'}, {'ForeName': 'Mary Klein', 'Initials': 'MK', 'LastName': 'Buller', 'Affiliation': 'President at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Meenan', 'Affiliation': 'Investigator at Kaiser Permanente Center for Health Research, Portland, OR, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Emeritus at the University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Research Program Manager at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Eye', 'Affiliation': 'Project Coordinator at Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Walkosz', 'Affiliation': 'Klein Buendel, Inc, Golden, CO, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pagoto', 'Affiliation': 'University of Connecticut, Storrs, CT, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106147']
2154,32948200,Phase II multicenter randomized controlled clinical trial on the efficacy of intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma for the treatment of knee osteoarthritis.,"BACKGROUND


Mesenchymal stromal cells are a safe and promising option to treat knee osteoarthritis as previously demonstrated in different clinical trials. However, their efficacy, optimal dose and addition of adjuvants must be determined. Here, we evaluated the clinical effects of a dose of 100 × 10 6  bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF®) as adjuvant in a randomized clinical trial.
METHODS


A phase II, multicenter, randomized clinical trial with active control was conducted. Sixty patients diagnosed with knee OA were randomly assigned to 3 weekly doses of PRGF® or intraarticular administration of 100 × 10 6  cultured autologous BM-MSCs plus PRGF®. Patients were followed up for 12 months, and pain and function were assessed using VAS and WOMAC and by measuring the knee range of motion range. X-ray and magnetic resonance imaging analyses were performed to analyze joint damage.
RESULTS


No adverse effects were reported after BM-MSC administration or during follow-up. According to VAS, the mean value (SD) for PRGF® and BM-MSC with PRGF® went from 5 (1.8) to 4.5 (2.2) (p = 0.389) and from 5.3 (1.9) to 3.5 (2.5) (p = 0.01), respectively at 12 months. In WOMAC, the mean (SD) baseline and 12-month overall WOMAC scores in patients treated with PRGF® was 31.9 (16.2) and 22.3 (15.8) respectively (p = 0.002) while that for patients treated with BM-MSC plus PRGF® was 33.4 (18.7) and 23.0 (16.6) (p = 0.053). Although statistical significances between groups have been not detected, only patients being treated with BM-MSC plus PRGF® could be considered as a OA treatment responders following OARSI criteria. X-ray and MRI (WORMS protocol) revealed no changes in knee joint space width or joint damage.
CONCLUSIONS


Treatment with BM-MSC associated with PRGF® was shown to be a viable therapeutic option for osteoarthritis of the knee, with clinical improvement at the end of follow-up. Further phase III clinical trials would be necessary to confirm the efficacy. Trial registration Clinical Trials.gov identifier NCT02365142. Nº EudraCT: 2011-006036-23.",2020,No adverse effects were reported after BM-MSC administration or during follow-up.,"['Sixty patients diagnosed with knee OA', 'knee osteoarthritis']","['PRGF® or intraarticular administration of 100\u2009×\u200910 6  cultured autologous BM-MSCs plus PRGF®', 'intra-articular injection of autologous bone marrow mesenchymal stem cells with platelet rich plasma', '100\u2009×\u200910 6  bone marrow mesenchymal stromal cells (BM-MSCs) in combination with Platelet Rich Plasma (PRGF®', 'X-ray and MRI (WORMS protocol']","['mean (SD) baseline and 12-month overall WOMAC scores', 'pain and function', 'adverse effects', 'knee joint space width or joint damage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C4704952', 'cui_str': 'Bone Marrow Mesenchymal Stem Cells'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",60.0,0.0966388,No adverse effects were reported after BM-MSC administration or during follow-up.,"[{'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Lamo-Espinosa', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain. jlamodeespi@unav.es.'}, {'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Blanco', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Complejo Universitario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Sánchez', 'Affiliation': 'Arthroscopic Surgery Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Froilán', 'Initials': 'F', 'LastName': 'Granero-Moltó', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'Sánchez-Guijo', 'Affiliation': 'Department of Haematology, Complejo Hospitalario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Íñigo', 'Initials': 'Í', 'LastName': 'Crespo-Cullel', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Complejo Universitario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Mora', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Diego Delgado', 'Initials': 'DD', 'LastName': 'San Vicente', 'Affiliation': 'Advanced Biological Therapy Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'Pompei-Fernández', 'Affiliation': 'Advanced Biological Therapy Unit, Hospital Vithas San José, Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Jesús Dámaso', 'Initials': 'JD', 'LastName': 'Aquerreta', 'Affiliation': 'Department of Radiology, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Jorge María', 'Initials': 'JM', 'LastName': 'Núñez-Córdoba', 'Affiliation': 'Division of Biostatistics, Research Support Service, Central Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Vitoria Sola', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Valentí-Azcárate', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Enrique J', 'Initials': 'EJ', 'LastName': 'Andreu', 'Affiliation': 'Cell Therapy Area, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del Consuelo Del Cañizo', 'Affiliation': 'Department of Haematology, Complejo Hospitalario de Salamanca-IBSAL, Salamanca, Spain.'}, {'ForeName': 'Juan Ramón', 'Initials': 'JR', 'LastName': 'Valentí-Nin', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Prósper', 'Affiliation': 'Cell Therapy Area, Clínica Universidad de Navarra, 36 Pío XII Avenue, 31008, Pamplona, Spain. fprosper@unav.es.'}]",Journal of translational medicine,['10.1186/s12967-020-02530-6']
2155,32948224,"Egg white hydrolyzate reduces mental fatigue: randomized, double-blind, controlled study.","OBJECTIVES


This study aimed to show that ingesting egg white hydrolyzate (EWH) could improve antioxidant capacity and reduce mental fatigue. Two clinical trials were conducted to examine the antioxidant capacity and the fatigue reduction function of EWH. In Study 1, 19 athlete students were received a single dose of EWH (5 g/day) or placebo. In Study 2, 74 athlete students ingested EWH (5 g/day) or placebo before training for 2 weeks.
RESULTS


Single dose of EWH significantly increased the antioxidant ability compared with the placebo group (p < 0.05), and there was no significant difference between the groups in the oxidative stress test results on Study 1. Two-week intake of EWH significantly decreased mental fatigue compared with the placebo (p < 0.05). This study showed that ingesting EWH improved antioxidant capacity with a single dose and reduced mental fatigue after 2 weeks of ingestion. Trial Registration Japan Medical Association Center for Clinical Trials identifier; JMA-IIA00395 (Study1) and JMA-IIA00396 (Study2), both trials were retrospectively registered on 26 October, 2018.",2020,"Single dose of EWH significantly increased the antioxidant ability compared with the placebo group (p < 0.05), and there was no significant difference between the groups in the oxidative stress test results on Study 1.","['74 athlete students ingested EWH (5\xa0g/day) or', 'Egg white hydrolyzate reduces mental fatigue', '19 athlete students']","['ingesting egg white hydrolyzate (EWH', 'placebo', 'EWH']","['antioxidant capacity', 'mental fatigue', 'antioxidant capacity and reduce mental fatigue', 'antioxidant ability']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0013704', 'cui_str': 'Egg white'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0013704', 'cui_str': 'Egg white'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.47525,"Single dose of EWH significantly increased the antioxidant ability compared with the placebo group (p < 0.05), and there was no significant difference between the groups in the oxidative stress test results on Study 1.","[{'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Oe', 'Affiliation': 'R&D Division, Kewpie Corporation, 2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan.'}, {'ForeName': 'Hisae', 'Initials': 'H', 'LastName': 'Sakamoto', 'Affiliation': 'R&D Division, Kewpie Corporation, 2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'R&D Division, Kewpie Corporation, 2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan.'}, {'ForeName': 'Ryou', 'Initials': 'R', 'LastName': 'Sasahara', 'Affiliation': 'R&D Division, Kewpie Corporation, 2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan.'}, {'ForeName': 'Yasunobu', 'Initials': 'Y', 'LastName': 'Masuda', 'Affiliation': 'R&D Division, Kewpie Corporation, 2-5-7, Sengawa-cho, Chofu-shi, Tokyo, Japan. yasunobu_masuda@kewpie.co.jp.'}, {'ForeName': 'Mizuho', 'Initials': 'M', 'LastName': 'Adachi', 'Affiliation': 'Nippon Sport Science University, 7-1-1 Fukazawa, Setagaya-ku, Tokyo, 158-8508, Japan.'}, {'ForeName': 'Tetsunari', 'Initials': 'T', 'LastName': 'Nishiyama', 'Affiliation': 'Nippon Sport Science University, 7-1-1 Fukazawa, Setagaya-ku, Tokyo, 158-8508, Japan.'}]",BMC research notes,['10.1186/s13104-020-05288-8']
2156,32948270,Letter to the editor: Inspiratory muscle training did not improve exercise capacity and lung function in adult patients with Fontan circulation: A randomized controlled trial.,,2020,,['adult patients with Fontan circulation'],['editor: Inspiratory muscle training'],['exercise capacity and lung function'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5197853', 'cui_str': 'Fontan Circuit'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.0485841,,"[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Department of Rehabilitation, Kobe City Medical Center General Hospital, 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe 650-0047, Japan; Department of Health Informatics, School of Public Health, Graduate School of Medicine, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan. Electronic address: sasaki.kosuke.u73@kyoto-u.jp.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Health Informatics, School of Public Health, Graduate School of Medicine, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Nakayama', 'Affiliation': 'Department of Health Informatics, School of Public Health, Graduate School of Medicine, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.05.069']
2157,32946451,Comparative functional survival and equivalent annual cost of 3 long-lasting insecticidal net (LLIN) products in Tanzania: A randomised trial with 3-year follow up.,"BACKGROUND


Two billion long-lasting insecticidal nets (LLINs) have been procured for malaria control. A functional LLIN is one that is present, is in good physical condition, and remains insecticidal, thereby providing protection against vector-borne diseases through preventing bites and killing disease vectors. The World Health Organization (WHO) prequalifies LLINs that remain adequately insecticidal 3 years after deployment. Therefore, institutional buyers often assume that prequalified LLINs are functionally identical with a 3-year lifespan. We measured the lifespans of 3 LLIN products, and calculated their cost per year of functional life, to demonstrate the economic and public health importance of procuring the most cost-effective LLIN product based on its lifespan.
METHODS AND FINDINGS


A randomised double-blinded trial of 3 pyrethroid LLIN products (10,571 nets in total) was conducted at 3 follow-up points: 10 months (August-October 2014), 22 months (August-October 2015), and 36 months (October-December 2016) among 3,393 households in Tanzania using WHO-recommended methods. Primary outcome was LLIN functional survival (LLIN present and in serviceable condition). Secondary outcomes were (1) bioefficacy and chemical content (residual insecticidal activity) and (2) protective efficacy for volunteers sleeping under the LLINs (bite reduction and mosquitoes killed). Median LLIN functional survival was significantly different between the 3 net products (p = 0.001): 2.0 years (95% CI 1.7-2.3) for Olyset, 2.5 years (95% CI 2.2-2.8) for PermaNet 2.0 (hazard ratio [HR] 0.73 [95% CI 0.64-0.85], p = 0.001), and 2.6 years (95% CI 2.3-2.8) for NetProtect (HR = 0.70 [95% CI 0.62-0.77], p < 0.001). Functional survival was affected by accumulation of holes, leading to users discarding nets. Protective efficacy also significantly differed between products as they aged. Equivalent annual cost varied between US$1.2 (95% CI $1.1-$1.4) and US$1.5 (95% CI $1.3-$1.7), assuming that each net was priced identically at US$3. The 2 longer-lived nets (PermaNet and NetProtect) were 20% cheaper than the shorter-lived product (Olyset). The trial was limited to only the most widely sold LLINs in Tanzania. Functional survival varies by country, so the single country setting is a limitation.
CONCLUSIONS


These results suggest that LLIN functional survival is less than 3 years and differs substantially between products, and these differences strongly influence LLIN value for money. LLIN tendering processes should consider local expectations of cost per year of functional life and not unit price. As new LLIN products come on the market, especially those with new insecticides, it will be imperative to monitor their comparative durability to ensure that the most cost-effective products are procured for malaria control.",2020,"Median LLIN functional survival was significantly different between the 3 net products (p = 0.001): 2.0 years (95% CI 1.7-2.3) for Olyset, 2.5 years (95% CI 2.2-2.8) for PermaNet 2.0 (hazard ratio [HR]","['3,393 households in Tanzania using WHO-recommended methods', 'Tanzania', '10,571 nets in total']","['pyrethroid LLIN products', '3 long-lasting insecticidal net (LLIN']","['Protective efficacy', 'Median LLIN functional survival', 'LLIN functional survival (LLIN present and in serviceable condition', 'Equivalent annual cost', 'LLIN functional survival', 'Functional survival', 'bioefficacy and chemical content (residual insecticidal activity) and (2) protective efficacy for volunteers sleeping under the LLINs (bite reduction and mosquitoes killed']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0597329', 'cui_str': 'Pyrethroid'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0243177', 'cui_str': 'chemical content'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0026584', 'cui_str': 'Family Culicidae'}, {'cui': 'C0162388', 'cui_str': 'Killing'}]",3.0,0.315453,"Median LLIN functional survival was significantly different between the 3 net products (p = 0.001): 2.0 years (95% CI 1.7-2.3) for Olyset, 2.5 years (95% CI 2.2-2.8) for PermaNet 2.0 (hazard ratio [HR]","[{'ForeName': 'Lena M', 'Initials': 'LM', 'LastName': 'Lorenz', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, United States of America.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Massue', 'Affiliation': 'National Institute for Medical Research, Amani Research Centre, Muheza, Tanzania.'}, {'ForeName': 'Zawadi', 'Initials': 'Z', 'LastName': 'Mageni Mboma', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Pigeon', 'Affiliation': 'Plant Protection Products and Biocides Physico-chemistry and Residues Unit, Agriculture and Natural Environment Department, Walloon Agricultural Research Centre, Gembloux, Belgium.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Vector Control Product Testing Unit, Ifakara Health Institute, Bagamoyo, Tanzania.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Kilian', 'Affiliation': 'Tropical Health, Montagut, Spain.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Lines', 'Affiliation': 'Department of Disease Control, Faculty of Infectious and Tropical Diseases, London School of Hygiene &Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Kisinza', 'Affiliation': 'National Institute for Medical Research, Amani Research Centre, Muheza, Tanzania.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Overgaard', 'Affiliation': 'Faculty of Science and Technology, Norwegian University of Life Sciences, Ås, Norway.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Moore', 'Affiliation': 'Vector Control Product Testing Unit, Ifakara Health Institute, Bagamoyo, Tanzania.'}]",PLoS medicine,['10.1371/journal.pmed.1003248']
2158,32946500,Impact of the extension of a performance-based financing scheme to nutrition services in Burundi on malnutrition prevention and management among children below five: A cluster-randomized control trial.,"Malnutrition is a huge problem in Burundi. In order to improve the health system response, the Ministry of Health piloted the introduction of malnutrition prevention and care indicators within its performance-based financing (PBF) scheme. Paying for units of services and for qualitative indicators is expected to enhance provision and quality of these nutrition services. The objective of this study is to assess the impacts of this intervention, on both child acute malnutrition recovery rates at health centre level and prevalence of chronic and acute malnutrition among children at community level. This study follows a cluster-randomized controlled evaluation design: 90 health centres (HC) were randomly selected for the study, 45 of them were randomly assigned to the intervention and received payment related to their performance in malnutrition activities, while the other 45 constituted the control group and got a simple budget allocation. Data were collected from baseline and follow-up surveys of the 90 health centres and 6,480 households with children aged 6 to 23 months. From the respectively 1,067 and 1,402 moderate and severe acute malnutrition transcribed files and registers, findings suggest that the intervention had a positive impact on moderate acute malnutrition recovery rates (OR: 5.59, p = 0.039 -at the endline, 78% in the control group and 97% in the intervention group) but not on uncomplicated severe acute malnutrition recovery rate (OR: 1.16, p = 0.751 -at the endline, 93% in the control group and 92% in the intervention group). The intervention also had a significant increasing impact on the number of children treated for acute malnutrition. Analyses from the anthropometric data collected among 12,679 children aged 6-23 months suggest improvements at health centre level did not translate into better results at community level: prevalence of both acute and chronic malnutrition remained high, precisely at the endline, acute and chronic malnutrition prevalence were resp. 8.80% and 49.90% in the control group and 8.70% and 52.0% in the intervention group, the differences being non-significant. PBF can contribute to a better management of malnutrition at HC level; yet, to address the huge problem of child malnutrition in Burundi, additional strategies are urgently required.",2020,"Analyses from the anthropometric data collected among 12,679 children aged 6-23 months suggest improvements at health centre level did not translate into better results at community level: prevalence of both acute and chronic malnutrition remained high, precisely at the endline, acute and chronic malnutrition prevalence were resp.","['children below five', '90 health centres (HC', '6,480 households with children aged 6 to 23 months', 'children at community level', '12,679 children aged 6-23 months']","['payment related to their performance in malnutrition activities, while the other 45 constituted the control group and got a simple budget allocation', 'PBF']","['uncomplicated severe acute malnutrition recovery rate', 'moderate acute malnutrition recovery rates', 'number of children treated for acute malnutrition']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}]","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]",12679.0,0.0481994,"Analyses from the anthropometric data collected among 12,679 children aged 6-23 months suggest improvements at health centre level did not translate into better results at community level: prevalence of both acute and chronic malnutrition remained high, precisely at the endline, acute and chronic malnutrition prevalence were resp.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Korachais', 'Affiliation': 'Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Nkurunziza', 'Affiliation': 'Global Health Institute, University of Antwerp, Belgium.'}, {'ForeName': 'Manassé', 'Initials': 'M', 'LastName': 'Nimpagaritse', 'Affiliation': 'Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Meessen', 'Affiliation': 'Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium.'}]",PloS one,['10.1371/journal.pone.0239036']
2159,32947459,"The Effects of Common Over-the-Counter Moisturizers on Skin Barrier Function: A Randomized, Observer-Blind, Within-Patient, Controlled Study.","BACKGROUND


Moisturizers possibly improve atopic dermatitis (AD) by restoration of skin barrier, although some have detrimental effects.
OBJECTIVE


The aim of the study was to estimate the effects of several routine moisturizers on barrier functions.
METHODS


This is a randomized, forearm-controlled, observer-blind study. Patients older than 12 years with clear to moderate AD were randomized to 1 of 4 moisturizers (Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Vaseline) applied to nonlesional skin of 1 forearm and no moisturizer to the opposite forearm for 4 weeks. Transepidermal water loss (TEWL), capacitance, pH, and TEWL after tape stripping were evaluated at weeks 0 and 4. In addition, participants without AD underwent baseline measurements only.
RESULTS


Twenty patients with AD completed the study. Baseline measurements between the AD group and 10 non-AD controls were similar. After the intervention (AD group), mean TEWL improved in the treated forearm and worsened in the untreated one, but the difference was not significant. There was no significant change in pH or in TEWL after tape stripping. Capacitance significantly improved in the moisturizer forearm. The study was underpowered as recruitment fell short.
CONCLUSIONS


The effects of moisturizers on nonlesional AD skin were small and need to be addressed when powering future studies. Broadening investigations beyond the classic barrier properties might be useful in future studies.",2020,"After the intervention (AD group), mean TEWL improved in the treated forearm and worsened in the untreated one, but the difference was not significant.","['Twenty patients with AD completed the study', 'Patients older than 12 years with clear to moderate AD']","['4 moisturizers (Cetaphil Cream, Aveeno Eczema Therapy Moisturizing Cream, CeraVe Moisturizing Cream, Vaseline']","['Skin Barrier Function', 'Capacitance', 'mean TEWL', 'Transepidermal water loss (TEWL), capacitance, pH, and TEWL after tape stripping', 'pH or in TEWL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0055144', 'cui_str': 'Cetaphil'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242264', 'cui_str': 'Capacitance, Electrical'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}]",20.0,0.0544485,"After the intervention (AD group), mean TEWL improved in the treated forearm and worsened in the untreated one, but the difference was not significant.","[{'ForeName': 'Yael Anne', 'Initials': 'YA', 'LastName': 'Leshem', 'Affiliation': 'From the Division of Dermatology, Beilinson Hospital, Petach Tikva, Israel.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McClanahan', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, Oregon.'}]","Dermatitis : contact, atopic, occupational, drug",['10.1097/DER.0000000000000623']
2160,32947587,Impact of Skin Suture Pattern on Incision Perfusion Using Intraoperative Laser Angiography: A Randomized Clinical Trial of Patients With Ankle Fractures.,"OBJECTIVES


To assess which skin suture pattern-simple, vertical mattress, horizontal mattress, Allgöwer-Donati (AD), or running subcuticular-enables the greatest degree of perfusion as measured by indocyanine green laser angiography after ankle fracture surgery.
DESIGN


Prospective, randomized.
SETTING


Level 1 Academic Trauma Center.
PATIENTS/PARTICIPANTS


Seventy-five patients undergoing ankle fracture surgery were prospectively randomized to 1 of 5 skin suture patterns (n = 15 per cohort). Patient demographics and operative parameters were similar between groups.
MAIN OUTCOME MEASUREMENTS


Skin perfusion was assessed intraoperatively after skin closure using indocyanine green laser angiography and quantified in fluorescence units. Two perfusion values were collected: (1) mean incision perfusion was the mean of 10 points along the incision and (2) mean perfusion impairment was the perfusion difference between the incision and the skin adjacent to it. We also collected a postoperative patient scar assessment score.
RESULTS


Running subcuticular closure had significantly better mean incision perfusion than all other closure patterns. Mean perfusion impairment also favored running subcuticular closure, which was significantly lower than all other suture patterns except AD. We found no patient perceived cosmetic differences between the 5 suture pattern types.
CONCLUSIONS


Running subcuticular suture pattern resulted in the greatest incision perfusion than simple, horizontal mattress, vertical mattress, and AD techniques after ankle fracture fixation.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Mean perfusion impairment also favored running subcuticular closure, which was significantly lower than all other suture patterns except AD.","['Patients With Ankle Fractures', 'Level 1 Academic Trauma Center', 'Seventy-five patients undergoing ankle fracture surgery']","['Skin Suture Pattern on Incision Perfusion Using Intraoperative Laser Angiography', 'skin suture pattern-simple, vertical mattress, horizontal mattress, Allgöwer-Donati (AD), or running subcuticular', '5 skin suture patterns', 'indocyanine green laser angiography']","['Mean perfusion impairment', 'greatest incision perfusion', 'Skin perfusion was assessed intraoperatively after skin closure using indocyanine green laser angiography and quantified in fluorescence units', 'mean incision perfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0191408', 'cui_str': 'Closure of skin by suture'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",75.0,0.110502,"Mean perfusion impairment also favored running subcuticular closure, which was significantly lower than all other suture patterns except AD.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Shorten', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, University of Vermont Medical Center, Burlington, VT.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Haimes', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Nesbit', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Bartlett', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schottel', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001787']
2161,32947839,Impact of Anticholinergic Medication Burden on Mobility and Falls in the Lifestyle Interventions for Elders (LIFE) Study.,"Anticholinergic cognitive burden (ACB) may be associated with detrimental effects on mobility and physical independence in older adults. We evaluated the incidence of major mobility disability (MMD), persistent major mobility disability (PMMD), and injurious falls among participants within the Lifestyle Interventions for Elders (LIFE) trial according to varied anticholinergic burden levels. Participants aged 70-89 years were randomized to a physical activity (PA) or successful aging (SA) intervention and evaluated by ACB medication use as a summed score of a previously developed ACB scale. Confounders included demographic characteristics, physical function, cognitive function, and fall history. Average participant follow-up was 2.6 years and included outcome assessment for MMD, PMMD, and injurious falls every six months. Adjusted proportional hazards models evaluated the independent effects of ACB scores as well as interaction effects with the intervention. Of the 1635 participants, 986 (60%) used ≥1 anticholinergic medication. Compared to those with no burden, participants with an ACB score of 1 demonstrated increased MMD (HR = 1.42 [1.13-1.78]), PMMD (HR = 1.53 [1.12-2.09]), and injurious falls (HR = 1.60 [1.10-2.32]). Results similar in magnitude were observed for all other ACB levels versus the no burden group. Stepwise dose-response comparisons between ACB groupings did not demonstrate significant differences in outcomes. Stratification by PA or SA interventions demonstrated few differences from the combined overall trial results. Compared to those not taking anticholinergic medications, participants taking anticholinergic medications generally demonstrated increased risk of MMD, PMMD, and injurious falls. Total anticholinergic burden was not associated with a stepwise dose-response relationship in mobility disability and may lack sensitivity to capture varied responses.",2020,"Compared to those not taking anticholinergic medications, participants taking anticholinergic medications generally demonstrated increased risk of MMD, PMMD, and injurious falls.","['older adults', 'Elders (LIFE) Study', 'Participants aged 70-89 years', '1635 participants, 986 (60%) used ≥1 anticholinergic medication']","['physical activity (PA) or successful aging (SA) intervention and evaluated by ACB medication', 'Anticholinergic cognitive burden (ACB']","['ACB levels', 'incidence of major mobility disability (MMD), persistent major mobility disability (PMMD), and injurious falls', 'demographic characteristics, physical function, cognitive function, and fall history', 'mobility and physical independence', 'MMD, PMMD, and injurious falls every six months', 'injurious falls', 'risk of MMD, PMMD, and injurious falls', 'Mobility and Falls', 'PMMD', 'MMD']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0585339', 'cui_str': 'Every six months'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1635.0,0.0385836,"Compared to those not taking anticholinergic medications, participants taking anticholinergic medications generally demonstrated increased risk of MMD, PMMD, and injurious falls.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Squires', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL 32611, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Institute on Aging, Department of Aging and Geriatric Research, University of Florida College of Medicine, Gainesville, FL 32610, USA.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Institute on Aging, Department of Aging and Geriatric Research, University of Florida College of Medicine, Gainesville, FL 32610, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Vouri', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL 32611, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Brown', 'Affiliation': 'Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL 32611, USA.'}]",Journal of clinical medicine,['10.3390/jcm9092989']
2162,32947920,"The Influence of Cyclical Ketogenic Reduction Diet vs. Nutritionally Balanced Reduction Diet on Body Composition, Strength, and Endurance Performance in Healthy Young Males: A Randomized Controlled Trial.","(1) Background: The influence of ketogenic diet on physical fitness remains controversial. We performed a randomized controlled trial to compare the effect of cyclical ketogenic reduction diet (CKD) vs. nutritionally balanced reduction diet (RD) on body composition, muscle strength, and endurance performance. (2) Methods: 25 healthy young males undergoing regular resistance training combined with aerobic training were randomized to CKD ( n  = 13) or RD ( n  = 12). Body composition, muscle strength and spiroergometric parameters were measured at baseline and after eight weeks of intervention. (3) Results: Both CKD and RD decreased body weight, body fat, and BMI. Lean body mass and body water decreased in CKD and did not significantly change in RD group. Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased. Similarly, endurance performance was not changed in CKD group while in RD group peak workload and peak oxygen uptake increased. (4) Conclusions: Our data show that in healthy young males undergoing resistance and aerobic training comparable weight reduction were achieved by CKD and RD. In RD group; improved muscle strength and endurance performance was noted relative to neutral effect of CKD that also slightly reduced lean body mass.",2020,Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased.,"['25 healthy young males undergoing', 'Healthy Young Males', 'healthy young males']","['Cyclical Ketogenic Reduction Diet vs. Nutritionally Balanced Reduction Diet', 'regular resistance training combined with aerobic training', 'cyclical ketogenic reduction diet (CKD) vs. nutritionally balanced reduction diet (RD', 'ketogenic diet', 'CKD']","['Body Composition, Strength, and Endurance Performance', 'Body composition, muscle strength and spiroergometric parameters', 'peak workload and peak oxygen uptake', 'lean body mass', 'Muscle strength parameters', 'weight reduction', 'endurance performance', 'muscle strength and endurance performance', 'body composition, muscle strength, and endurance performance', 'Lean body mass and body water decreased in CKD', 'body weight, body fat, and BMI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005909', 'cui_str': 'Body water'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",25.0,0.026568,Muscle strength parameters were not affected in CKD while in RD group lat pull-down and leg press values increased.,"[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Kysel', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Denisa', 'Initials': 'D', 'LastName': 'Haluzíková', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Radka Petráková', 'Initials': 'RP', 'LastName': 'Doležalová', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Laňková', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Zdeňka', 'Initials': 'Z', 'LastName': 'Lacinová', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Barbora Judita', 'Initials': 'BJ', 'LastName': 'Kasperová', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Jaroslava', 'Initials': 'J', 'LastName': 'Trnovská', 'Affiliation': 'Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Viktorie', 'Initials': 'V', 'LastName': 'Hrádková', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Miloš', 'Initials': 'M', 'LastName': 'Mráz', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}, {'ForeName': 'Zdeněk', 'Initials': 'Z', 'LastName': 'Vilikus', 'Affiliation': 'Department of Sports Medicine, First Faculty of Medicine and General University Hospital, 12000 Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': 'Diabetes Centre, Institute for Clinical and Experimental Medicine, 12000 Prague, Czech Republic.'}]",Nutrients,['10.3390/nu12092832']
2163,32947959,Unimanual Intensive Therapy with or without Unaffected Hand Containment in Children with Hemiplegia. A Randomized Controlled Pilot Study.,"Children with hemiplegia have lower spontaneous use and quality of movement in the affected upper limb. The modified constraint-induced movement therapy (mCIMT) is applied to improve the affected upper limb function. The objective of this study was to study the efficacy of unaffected hand containment to obtain changes in the function of the affected upper limb after applying two unimanual therapies. A randomized controlled pilot study was performed with 16 children diagnosed with congenital infantile hemiplegia, with eight children randomized in each group (average age: 5.54 years; SD: 1.55). mCIMT and unimanual therapy without containment (UTWC) were applied, with a total of 50 h distributed in five weeks (two h/per day). Two assessments were performed (pre- and post-treatment) to evaluate the affected upper limb spontaneous use, measured with the Shiners Hospital Upper Extremity Evaluation (SHUEE), and the quality of movement, measured with the Quality of Upper Extremity Skills Test (QUEST scale). The progression of the variables was different in both groups. The results are expressed in the median of the improvement percent and interquartile range (IQR). The spontaneous use analysis showed an improvement percent of 31.65 (IQR: 2.33, 110.42) in the mCIMT group with respect to 0.00 (IQR: 0.00, 0.00) in the UTWC group. The quality of movement increased in the mCIMT and UTWC groups, 24.21 (IQR: 13.44, 50.39), 1.34 (IQR: 0.00, 4.75), respectively and the greatest increase was obtained in the grasp variable for both groups. The use of unaffected hand containment in mCIMT would produce improvements in the affected upper limb functionality in children with hemiplegia (4-8 years old) compared to the same protocol without containment (UTWC).",2020,"The spontaneous use analysis showed an improvement percent of 31.65 (IQR: 2.33, 110.42) in the mCIMT group with respect to 0.00 (IQR: 0.00, 0.00) in the UTWC group.","['Children with Hemiplegia', 'Children with hemiplegia', 'children with hemiplegia (4-8 years old', '16 children diagnosed with congenital infantile hemiplegia, with eight children randomized in each group (average age: 5.54 years; SD: 1.55']","['modified constraint-induced movement therapy (mCIMT', 'mCIMT and unimanual therapy without containment (UTWC']","['interquartile range (IQR', 'quality of movement', 'Shiners Hospital Upper Extremity Evaluation (SHUEE), and the quality of movement, measured with the Quality of Upper Extremity Skills Test (QUEST scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0392550', 'cui_str': 'Infantile hemiplegia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0524540', 'cui_str': 'Shiner'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",16.0,0.0368662,"The spontaneous use analysis showed an improvement percent of 31.65 (IQR: 2.33, 110.42) in the mCIMT group with respect to 0.00 (IQR: 0.00, 0.00) in the UTWC group.","[{'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Palomo-Carrión', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pinero-Pinto', 'Affiliation': 'Department of Physical Therapy, Faculty of Nursery, Physiotherapy and Podiatry, University of Seville, 49001 Seville, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ando-LaFuente', 'Affiliation': 'Physiotherapy Research Group in Toledo, GIFTO, 45071 Toledo, Spain.'}, {'ForeName': 'Asunción', 'Initials': 'A', 'LastName': 'Ferri-Morales', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bravo-Esteban', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Romay-Barrero', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9092992']
2164,32950444,Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After Mitraclip Implantation: Results From the Mitra-FR Trial.,"OBJECTIVES


This study aimed to identify a subset of patients based on echocardiographic parameters who might have benefited from transcatheter correction using the Mitraclip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial.
BACKGROUND


It has been suggested that differences in the degree of mitral regurgitation (MR) and left ventricular (LV) remodeling may explain the conflicting results between the MITRA-FR and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trials.
METHODS


In a post hoc analysis, we evaluated the interaction between the intervention and subsets of patients defined based on MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24 months.
RESULTS


We observed a neutral impact of the intervention in subsets with the highest MR degree (ERO ≥30 mm 2 , RVOL ≥45 ml or RF ≥50%) as in patients with milder MR degree. The same was seen in subsets with the milder LV remodeling using either diastolic or systolic diameters or volumes. When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-diastolic volume ratio ≥ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients.
CONCLUSIONS


In the MITRA-FR trial, we could not identify a subset of patients defined based on the degree of the regurgitation, LV remodeling or on their combination, including those deemed as having disproportionate MR, that might have benefited from transcatheter correction using the Mitraclip system. (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR]; NCT01920698).",2020,"When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-diastolic volume ratio ≥ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients.
","['subsets with the highest MR degree (ERO\xa0≥30\xa0mm 2 , RVOL\xa0≥45', 'With Severe Secondary Mitral Regurgitation [MITRA-FR', 'Patients', 'Heart\xa0Failure Patients with Functional Mitral Regurgitation) trials', 'patients based on echocardiographic parameters who might have benefited from transcatheter correction using the Mitraclip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial']","['Percutaneous Mitral Valve Repair MitraClip Device', 'Mitraclip Implantation', 'ml or RF', 'MitraClip Percutaneous Therapy']","['MR severity and LV remodeling', 'MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24\xa0months']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1302309', 'cui_str': 'Regurgitant fraction'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0446211,"When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-diastolic volume ratio ≥ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Messika-Zeitoun', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada. Electronic address: DMessika-zeitoun@ottawaheart.ca.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Iung', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France; APHP, Hôpital Bichat, DHU FIRE, Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Armoiry', 'Affiliation': 'Edouard Herriot Hospital, Pharmacy Department/Claude Bernard University- Laboratoire MATEIS, Lyon, France.'}, {'ForeName': 'Jean-Noël', 'Initials': 'JN', 'LastName': 'Trochu', 'Affiliation': ""Université Nantes, CHU Nantes, CNRS, INSERM, l'institut du Thorax, Nantes, France.""}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Donal', 'Affiliation': 'CHU de Rennes, Hôpital Pontchaillou, Rennes, France and LTSI UMR1099, INSERM, Universite de Rennes-1, Rennes, France.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Habib', 'Affiliation': 'APHM, La Timone Hospital, Cardiology Department, Marseille France; Aix Marseille Univ, IRD, APHM, MEPHI, IHU-Méditerranée Infection, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Brochet', 'Affiliation': 'APHP, Hôpital Bichat, DHU FIRE, Paris, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Thibault', 'Affiliation': ""Groupement Hospitalier Est, Hospices Civils de Lyon, Service d'Explorations Fonctionnelles Cardiovasculaires, Bron, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Piriou', 'Affiliation': ""Université Nantes, CHU Nantes, CNRS, INSERM, l'institut du Thorax, Nantes, France.""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cormier', 'Affiliation': 'Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tribouilloy', 'Affiliation': 'Department of Cardiology, Amiens University Hospital, EA 7517 MP3CV, Jules Verne University of Picardie, Amiens, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Guerin', 'Affiliation': 'CHU Nantes, INSERM UMR 1229, Nantes University, Interventional Cardiology unit, Institut du Thorax, Nantes, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': 'Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Maucort-Boulch', 'Affiliation': 'Université Lyon 1, Villeurbanne, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Villeurbanne, France.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'Vahanian', 'Affiliation': 'Université de Paris and INSERM 1148, Paris, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Université Lyon 1, Villeurbanne, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Villeurbanne, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Obadia', 'Affiliation': 'Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France. Electronic address: jean-francois.obadia@chu-lyon.fr.'}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2020.07.021']
2165,32950477,Letter to editor RE: Physical Exam Indicated Cerclage in Twin pregnancy: a Randomized Controlled Trial.,,2020,,['Twin pregnancy'],"['Physical Exam Indicated Cerclage', 'Letter to editor RE']",[],"[{'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]",[],,0.186319,,"[{'ForeName': 'J A P L E E N', 'Initials': 'JAPLEEN', 'LastName': 'Kaur', 'Affiliation': 'Department of Obstetrics and Gynecology , Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh(UT), India -160012.'}, {'ForeName': 'A V I R', 'Initials': 'AVIR', 'LastName': 'Sarkar', 'Affiliation': 'Department of Obstetrics and Gynecology , Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh(UT), India -160012.'}, {'ForeName': 'M I N A K S H I', 'Initials': 'MINAKSHI', 'LastName': 'Rohilla', 'Affiliation': 'Department of Obstetrics and Gynecology , Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh(UT), India -160012. Electronic address: minurohilla@yahoo.com.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.09.019']
2166,32950479,Reply: Physical Exam Indicated Cerclage in Twin pregnancy: a Randomized Controlled Trial.,,2020,,['Twin pregnancy'],['Reply: Physical Exam Indicated Cerclage'],[],"[{'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1292825', 'cui_str': 'Cerclage'}]",[],,0.193605,,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Roman', 'Affiliation': 'Maternal-Fetal Medicine Division, Obstetrics and Gynecology Department, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, United States. Electronic address: amanda.roman@jefferson.edu.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.09.020']
2167,32950505,Social media use while listening to new material negatively affects short-term memory in college students.,"Increased access to electronic devices and the ubiquity of social media has resulted in a rapid rise in the prevalence of students ""multitasking"" while in a classroom setting. While some data indicate the use of electronic devices in class can improve the classroom environment, other studies demonstrate the opposite finding. Moreover, it remains unclear if using social networking sites such as Instagram impacts performance on cognitive tasks when students are presented new material and, if so, what features of Instagram modulate this response. Therefore, in the current study we examined if social media use during or after being presented new information affected short-term memory in college students. Additionally, we assessed if the type or quantity of topics displayed had a modulatory impact on memory. Forty-five college-aged (18-24 years of age) students completed the Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory. Subjects were randomly divided into a group that completed the LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM I after scrolling through their Instagram feed. Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01). Recall ability in the group that used Instagram after hearing the story was not statistically different from the controls. Differences were not observed in the number of topics appearing in subjects' Instagram feeds and no correlation was found between the number of topics on a subject's Instagram feed and memory recall ability. Collectively, these results suggest that individuals who use their phones to browse Instagram during class or in social settings might have a reduced ability to retain the information given to them when compared to those that are not using their phones scrolling on social media.",2020,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"['Forty-five college-aged (18-24 years of age', 'college students', 'College Students']","['LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM']","['Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory', 'Recall ability', 'short-term memory recall ability']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.024727,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"[{'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Spence', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Kierian', 'Initials': 'K', 'LastName': 'Beasley', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Gravenkemper', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hoefler', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ngo', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ortiz', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Campisi', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA. Electronic address: jcampisi@regis.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113172']
2168,32950546,Twice-weekly topical calcipotriene / betamethasone dipropionate foam as proactive management of plaque psoriasis increases time in remission and is well tolerated over 52 weeks (PSO-LONG trial).,"BACKGROUND


Topical psoriasis treatment relies on a reactive, rather than long-term proactive, approach to disease relapse.
OBJECTIVE


Assess long-term efficacy and safety of proactive psoriasis management with twice-weekly calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam.
METHODS


Phase III trial (NCT02899962) included a 4-week open-label lead-in phase (Cal/BD foam once-daily) and 52-week, randomized, double-blind, maintenance phase. 545 patients achieved treatment success PGA 'clear'/'almost clear', ≥2-grade improvement from baseline) and were randomized to 'proactive' management (Cal/BD foam; n = 272) or 'reactive' management (vehicle foam; n = 273) twice-weekly, with rescue treatment of Cal/BD foam once-daily for 4 weeks upon relapse. Primary endpoint: time to first relapse (PGA ≥'mild').
RESULTS


251 (46.1%) randomized patients completed the trial. Median time to first relapse: 56 days (proactive), 30 days (reactive). Patients in the proactive group had an additional 41 days in remission compared with the reactive group over 1 year (P < 0.001). Number of relapses per year of exposure: 3.1 (proactive), 4.8 (reactive). Cal/BD foam was well tolerated.
LIMITATIONS


Maintenance phase dropout rate (53.9%) was within the expected range but provides challenges in statistical analysis.
CONCLUSION


Long-term proactive management with Cal/BD foam demonstrated superior efficacy versus reactive management.",2020,Patients in the proactive group had an additional 41 days in remission compared with the reactive group over 1 year (P < 0.001).,['545 patients'],"['calcipotriene / betamethasone dipropionate', 'proactive psoriasis management with twice-weekly calcipotriene', '0.005%/betamethasone dipropionate', '4-week open-label lead-in phase (Cal/BD foam once-daily']","[""time to first relapse (PGA ≥'mild"", 'tolerated', 'Median time']","[{'cui': 'C4517809', 'cui_str': '545'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4517414', 'cui_str': '0.064'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.227363,Patients in the proactive group had an additional 41 days in remission compared with the reactive group over 1 year (P < 0.001).,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: lebwohl@aol.com.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Liljedahl', 'Affiliation': 'LEO Pharma Ballerup, Denmark.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynde', 'Affiliation': 'Lynde Dermatology, Probity Medical Research, Markham, ON, Canada; Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Marie Holst', 'Initials': 'MH', 'LastName': 'Mørch', 'Affiliation': 'LEO Pharma Ballerup, Denmark.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research, Waterloo, ON, Canada.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Perrot', 'Affiliation': 'Department of Dermatology, University Hospital of St-Etienne, St-Etienne, France.'}, {'ForeName': 'Linda Stein', 'Initials': 'LS', 'LastName': 'Gold', 'Affiliation': 'Department of Dermatology, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Amrit', 'Initials': 'A', 'LastName': 'Takhar', 'Affiliation': 'Wansford and Kings Cliffe Practice, Wansford, Cambridgeshire, UK.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, M6 8HD, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergology, Ludwig Maximilian University Munich, Munich, Germany.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.09.037']
2169,32950549,Music Reduces Pain and Anxiety Associated with Local Anesthesia for Dermatologic Procedures: A Randomized Controlled Trial.,,2020,,['Dermatologic Procedures'],[],['Pain and Anxiety'],"[{'cui': 'C0205489', 'cui_str': 'Dermatologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.229353,,"[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Sorensen', 'Affiliation': 'Division of Dermatology, Washington University in St. Louis, Saint Louis, MO, USA; Division of Biostatistics, Washington University in St. Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Division of Dermatology, Washington University in St. Louis, Saint Louis, MO, USA; Division of Biostatistics, Washington University in St. Louis, Saint Louis, MO, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tabacchi', 'Affiliation': 'Division of Dermatology, Washington University in St. Louis, Saint Louis, MO, USA; Division of Biostatistics, Washington University in St. Louis, Saint Louis, MO, USA.'}, {'ForeName': 'M Laurin', 'Initials': 'ML', 'LastName': 'Council', 'Affiliation': 'Division of Dermatology, Washington University in St. Louis, Saint Louis, MO, USA; Division of Biostatistics, Washington University in St. Louis, Saint Louis, MO, USA. Electronic address: mcouncil@wustl.edu.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.09.034']
2170,32950674,"The use of dry needling versus corticosteroid injection to treat lateral epicondylitis: a prospective, randomized, controlled study.","BACKGROUND


Lateral epicondylitis (LE) is a common disease especially at middle age. To address LE different types of treatments have been used. Corticosteroid (CS) injections and dry needling (DN) are utilized options in the treatment. However, the question of which one is better has not been entirely discussed in the literature. We hypothesized that the use of DN to treat LE would be at least as effective as using CS injections. We compared the pain relief afforded and improvements in functional disability after DN and CS injection.
METHODS


A total of 108 LE patients whose pain was not relieved by 3 weeks of first-line treatment were included in a randomized manner, using an online application into DN or CS groups (54 patients each). The minimum follow-up duration was 6 months. We recorded ""Patient-rated Tennis Elbow Evaluation"" (PRTEE) scores before treatment, and after 3 weeks and 6 months of treatment.
RESULTS


Seven patients were excluded for various reasons, thus 101 patients were finally evaluated. Before treatment, the groups were similar in terms of age, symptom duration, and PRTEE score, but after treatment, DN-treated patients showed better improvement in the PRTEE score than CS-treated patients (p <0.01). Both treatments were effective (both p <0.01). From assessments at 3 weeks and 6 months post-treatment, PRTEE scores decreased over time. Four CS-treated patients (7.6%) developed skin atrophy and whitening. One DN-treated patient (2.04%) could not tolerate the pain of the intervention and withdrew from treatment.
CONCLUSION


DN and CS injection afforded significant improvements during the 6 months of follow-up. However, compared to CS injection, DN was more effective.
LEVEL OF EVIDENCE


Level II; Randomized Controlled Trial; Treatment Study.",2020,"Before treatment, the groups were similar in terms of age, symptom duration, and PRTEE score, but after treatment, DN-treated patients showed better improvement in the PRTEE score than CS-treated patients (p <0.01).","['108 LE patients whose pain was not relieved by 3 weeks of first-line treatment', 'Seven patients were excluded for various reasons, thus 101 patients were finally evaluated', 'lateral epicondylitis']","['DN and CS injection', 'Corticosteroid (CS) injections and dry needling (DN', 'dry needling versus corticosteroid injection']","['functional disability', 'skin atrophy and whitening', 'Patient-rated Tennis Elbow Evaluation"" (PRTEE) scores', 'pain relief']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0151514', 'cui_str': 'Atrophic condition of skin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",108.0,0.0608153,"Before treatment, the groups were similar in terms of age, symptom duration, and PRTEE score, but after treatment, DN-treated patients showed better improvement in the PRTEE score than CS-treated patients (p <0.01).","[{'ForeName': 'Esat', 'Initials': 'E', 'LastName': 'Uygur', 'Affiliation': 'Orthopaedics and Traumatology, İstanbul Medeniyet University, Göztepe Training and Research Hospital, İstanbul, Turkey. Electronic address: esatuygur@gmail.com.'}, {'ForeName': 'Birol', 'Initials': 'B', 'LastName': 'AktaŞ', 'Affiliation': 'Orthopaedics and Traumatology, Acıbadem Hospital, İstanbul, Turkey. Electronic address: ortobirol@gmail.com.'}, {'ForeName': 'Emime', 'Initials': 'E', 'LastName': 'Gül Yilmazoglu', 'Affiliation': 'Physiotherapist, İstanbul Medeniyet University, Erenköy Training and Research Hospital, İstanbul, Turkey. Electronic address: emime061834@gmail.com.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.08.044']
2171,32950693,Analysis of Time to Complete Response after Defibrotide Initiation in Patients with Hepatic Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome after Hematopoietic Cell Transplantation.,"Hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a potentially life-threatening complication that occurs after hematopoietic cell transplantation (HCT). Mortality associated with untreated VOD/SOS with multi-organ dysfunction (MOD) has been reported to be >80%. The recommended dose of defibrotide is 6.25 mg/kg every 6 hours, administered as a 2-hour intravenous infusion, for a minimum of 21 days or until resolution of VOD/SOS signs and symptoms. The objective of this analysis was to evaluate the time to complete response (CR) in patients with VOD/SOS post-HCT treated with defibrotide. Time to defibrotide discontinuation due to CR was used as a surrogate for time to CR in an expanded access study (T-IND; NCT00628498; n = 1000), and was analyzed separately from time to CR data pooled from a phase 2, randomized, dose-finding study (NCT00003966; n = 74 patients who received 25 mg/kg/day) and a phase 3, historically controlled study (NCT00358501; n = 102). For all studies, CR was defined as total serum bilirubin <2 mg/dL with resolution of VOD/SOS-related MOD (renal and/or pulmonary dysfunction); the phase 2 study also required resolution of central nervous system dysfunction. In the T-IND, 390 patients discontinued treatment due to a CR and had sufficient data for analysis. The median time to discontinuation was 22 days (range, 2 to 64 days). Discontinuation due to a CR occurred beyond 21 days in 235 (60%) patients and beyond 28 days in 57 (15%) patients. The pooled phase 2 and 3 studies had 60 patients who achieved a CR; the median time to CR was 24.5 days (range, 7 to 123 days). A CR was achieved beyond 21 days in 32 (53%) patients and beyond 28 days in 24 (40%) patients. The Kaplan-Meier-estimated Day 100 survival rate was substantially higher in patients who discontinued due to a CR than those who did not (92.5% vs 37.3%). Treatment-emergent adverse events occurred in 185/390 (47%) patients who discontinued due to a CR in the T-IND and in 55/60 (92%) patients who achieved a CR in the pooled phase 2 and 3 studies and rates did not differ according to duration of treatment (≤21 days versus >21 days). Together these results highlight the importance of continued defibrotide therapy until resolution of VOD/SOS signs and symptoms, as currently indicated in the approved product labels, which may occur beyond the recommended minimum of 21 days.",2020,The Kaplan-Meier-estimated Day 100 survival rate was substantially higher in patients who discontinued due to a CR than those who did not (92.5% vs 37.3%).,"['Patients with Hepatic Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome after Hematopoietic Cell Transplantation', 'Hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS', 'patients with VOD/SOS post-HCT treated with']",['defibrotide'],"['Mortality', 'total serum bilirubin', 'median time to discontinuation', 'median time to CR', 'Treatment-emergent adverse events', 'time to complete response (CR', 'Kaplan-Meier-estimated Day 100 survival rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019156', 'cui_str': 'Veno-occlusive disease of the liver'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0057257', 'cui_str': 'defibrotide'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1720943', 'cui_str': 'Kaplan-Meier Analysis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0539795,The Kaplan-Meier-estimated Day 100 survival rate was substantially higher in patients who discontinued due to a CR than those who did not (92.5% vs 37.3%).,"[{'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Department of Medical Oncology, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. Electronic address: Paul_Richardson@dfci.harvard.edu.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Smith', 'Affiliation': 'Department of Pediatrics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Kernan', 'Affiliation': 'Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Lehmann', 'Affiliation': 'Department of Pediatric Hematology/Oncology, Center for Stem Cell Transplantation, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ryan', 'Affiliation': 'Jazz Pharmaceuticals, Philadelphia, PA, USA.'}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Grupp', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.09.008']
2172,32950726,Efficacy of antimicrobial photodynamic therapy against halitosis in adolescent patients undergoing orthodontic treatment.,"PURPOSE


The aim of the present randomized controlled clinical trial was to evaluate the efficacy of photodynamic therapy (PDT) on halitosis in adolescent patients undergoing fixed orthodontic treatment.
MATERIALS AND METHODS


Forty-five adolescents with halitosis undergoing orthodontic treatment were equally randomized into three groups: Group - I: provision of treatment through PDT on dorsum of tongue; Group - II: provision of treatment with the help of tongue scrappers (TS); Group - III: provision of treatment with the help of TS and adjunctive PDT. Presence of halitosis confirmed on the basis of gas chromatography and estimation of oral malodour with a cysteine challenge and H 2 S values recorded ≥112 parts per billion (ppb). A portable device Oral Chroma TM  was used for performing breath analysis. A total of 5 bacterial species including P. gingivalis, F. nucleatum, P. intermedia, T. forsythia and T. denticola were studied as the proportion of sites defined as having ≥1.0 × 10 5  bacterial cells.
RESULTS


The mean age of the participants in Group-I, II and III were 15.4 years, 13.8 years, and 14.2 years, respectively. The median values for Group-I, II and III at initial breath analysis were 874 ppb, 613 ppb and 1089 ppb, respectively. After treatment with the respective therapeutic modalities, a statistically significant difference was seen among groups after 2-weeks (p < 0.0001) (Table 3). After applying Kruskal-Wallis test, group-III showed the highest amount of reduction in H 2 S concentration (100%) at final 2-weeks breath analysis compared to group-I and group-II (p = 0.0001). Descriptive statistics for all bacteria showed that group-III (TS + PDT) statistically significantly reduced the proportional distribution of all bacteria at 2-week follow-up (p < 0.0001) compared to group-I or group-II.
CONCLUSION


PDT along with tongue scrapping showed effective immediate reduction of H 2 S concentration and reduction of oral pathogens in adolescent patients undergoing fixed orthodontic treatment only in short-term. Long-term evaluation and complete eradication of halitosis needs to be explored in further clinical trials. In addition, the cost of PDT and its potential side effects should not be disregarded.",2020,"A total of 5 bacterial species including P. gingivalis, F. nucleatum, P. intermedia, T. forsythia and T. denticola were studied as the proportion of sites defined as having ≥1.0 × 10 5  bacterial cells.
","['The mean age of the participants in Group-I, II and III were 15.4 years, 13.8 years, and 14.2 years, respectively', 'Forty-five adolescents with halitosis undergoing orthodontic treatment', 'adolescent patients undergoing fixed orthodontic treatment', 'adolescent patients undergoing fixed orthodontic treatment only in short-term', 'adolescent patients undergoing orthodontic treatment']","['Group - I: provision of treatment through PDT on dorsum of tongue; Group - II: provision of treatment with the help of tongue scrappers (TS); Group - III: provision of treatment with the help of TS and adjunctive PDT', 'antimicrobial photodynamic therapy', 'photodynamic therapy (PDT']","['proportional distribution of all bacteria', 'effective immediate reduction of H 2 S concentration and reduction of oral pathogens', 'highest amount of reduction in H 2 S concentration']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0226952', 'cui_str': 'Structure of dorsum of tongue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0205250', 'cui_str': 'High'}]",45.0,0.0267428,"A total of 5 bacterial species including P. gingivalis, F. nucleatum, P. intermedia, T. forsythia and T. denticola were studied as the proportion of sites defined as having ≥1.0 × 10 5  bacterial cells.
","[{'ForeName': 'Aziz Alshahrani', 'Initials': 'AA', 'LastName': 'Abdul', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Kingdom of Saudi Arabia. Electronic address: alshahraniabdulaziz76@gmail.com.'}, {'ForeName': 'Alhaizaey', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Abdullah Kamran', 'Initials': 'AK', 'LastName': 'Muhammad', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Kingdom of Saudi Arabia.'}, {'ForeName': 'Alshahrani', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Kingdom of Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102019']
2173,32950728,Influence of silver diamine fluoride compared to photodynamic therapy on the bond integrity of resin modified glass ionomer cement to demineralized dentin.,"AIM


To investigate the adhesive bond integrity of demineralized dentin (DD) treated with Silver Diamine Fluoride (SDF) and Photodynamic therapy (PDT) (SBS) bonded to resin modified glass ionomer cement (RMGIC).
MATERIAL AND METHODS


Sixty non-carious molars were mounted within the sections of polyvinyl pipes. Dentinal tubules were exposed, homogenized and polished. 10 samples were left untreated and categorized as group 1. Fifty samples were exposed to acetic acid for artificial demineralization and randomly allocated into 5 groups. Group 2- exposed to conditioner polyacrylic acid (PAA); group 3- samples were treated with 38 % SDF; group 4- samples protected by 3.8 % SDF; group 5- topical application of 38 % SDF along with and potassium iodide (KI) and group 6- DD was treated with PDT. All specimens were bonded to RMGIC, light cured and subjected to shear bond testing in a universal testing machine. Debonded surfaces were observed under optical microscopy at 40x magnification for failure modes. SBS was examined using analysis of variance (ANOVA) with Post-hoc test. For all test p-value less than 0.5 was considered statistically significant.
RESULTS


Bond strength in group 5 specimens, (38 % SDF and KI - 15.91 ± 0.71 MPa) was significantly higher among all study groups (p < 0.05). The minimum SBS observed in group 1 samples, (mineralized dentin bonded to RMGIC- 7.44 ± 0.29 MPa) was significantly lower among tested treatment regimes. Samples in group 2 (DD conditioned with PAA and bonded to RMGIC) (11.39 ± 0.54 MPa), group 3 (DD treated with 38 % SDF) (12.42 ± 0.77 MPa) and group 6 (PDT treated DD) (11.52 ± 0.86 MPa) exhibited comparable outcomes (p > 0.05).
CONCLUSION


Demineralized dentin (DD) treated with 38 % SDF and potassium iodide when bonded to RMGIC exhibited improved bond strength compared to other treatment regimes. Use of methylene blue photosensitizer for PDT, compromised adhesive integrity applied on DD.",2020,Demineralized dentin (DD) treated with 38 % SDF and potassium iodide when bonded to RMGIC exhibited improved bond strength compared to other treatment regimes.,"['resin modified glass ionomer cement to demineralized dentin', 'Sixty non-carious molars']","['SDF; group 4- samples protected by 3.8 % SDF; group 5- topical application of 38 % SDF along with and potassium iodide (KI) and group', 'silver diamine fluoride', 'conditioner polyacrylic acid (PAA', 'acetic acid', 'Demineralized dentin (DD', 'photodynamic therapy', 'demineralized dentin (DD) treated with Silver Diamine Fluoride (SDF) and Photodynamic therapy (PDT) (SBS', 'PDT']","['minimum SBS', 'SBS', 'bond strength']","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0032831', 'cui_str': 'Potassium Iodide'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0054720', 'cui_str': 'Carbomer-940'}, {'cui': 'C0267964', 'cui_str': 'Pancreatic acinar atrophy'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}]","[{'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",60.0,0.0261229,Demineralized dentin (DD) treated with 38 % SDF and potassium iodide when bonded to RMGIC exhibited improved bond strength compared to other treatment regimes.,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alshahrani', 'Affiliation': 'Prosthetic Dental Science Department, College Of Dentistry, King Saud University, Riyadh, 11545, Saudi Arabia. Electronic address: shahraniabd1@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102007']
2174,32950830,Montelukast combined with intranasal mometasone furoate versus intranasal mometasone furoate; a comparative study in treatment of adenoid hypertrophy.,"OBJECTIVES


To evaluate the role of combined therapy using montelukast and intranasal mometasone furoate compared to intranasal mometasone furoate alone in treatment of adenoid hypertrophy regarding efficacy and recurrence rate.
METHODS


The study included 100 children with adenoid hypertrophy, they were randomly assigned to two groups. Group I (50 patients) received combined therapy using montelukast and mometasone furoate nasal spray. Group II (50 patients) received only mometasone furoate nasal spray. Patients were treated for 3 months and observed for 3 months after stoppage of treatment. Patients were evaluated using symptoms scores, Adenoid/Nasopharyngeal ratio and endoscopic grading of adenoid hypertrophy.
RESULTS


After 3 months of treatment, group I showed significant better scores of main symptoms than group II; (P = 0.001), (P = 0.019) and (P = 0.008) for rhinorrhea, mouth breathing and snoring respectively. The mean A/N ratio was 52.8 ± 11.3 in group I better than 62.88 ± 12.10 in group II (P < 0.001). Regarding the adenoid hypertrophy grading, significant reduction in size was found in group I in 34 (68%) patients better than in group II in 18 (36%) patients (P = 0.001). After further 3 months of follow up, the mean A/N ratio was 58.46 ± 10.05 in group I better than 66.36 ± 10.46 in group II (P < 0.001). Recurrence occurred in 8 (23.5%) cases out of 34 improved cases in group I better than 10 (55.5%) cases out of 18 cases in group II (P = 0.02).
CONCLUSION


Combining oral montelukast with intranasal mometasone in treatment of adenoid hypertrophy provided better improvements and less recurrence in comparison with single therapy using intranasal mometasone alone.",2020,"After 3 months of treatment, group I showed significant better scores of main symptoms than group II; (P = 0.001),","['adenoid hypertrophy', '100 children with adenoid hypertrophy']","['mometasone furoate nasal spray', 'intranasal mometasone furoate', 'combined therapy using montelukast and mometasone furoate nasal spray', 'montelukast and intranasal mometasone furoate', 'Montelukast combined with intranasal mometasone furoate', 'intranasal mometasone']","['rhinorrhea, mouth breathing and snoring respectively', 'Recurrence', 'scores of main symptoms', 'symptoms scores, Adenoid/Nasopharyngeal ratio and endoscopic grading of adenoid hypertrophy']","[{'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}]","[{'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0026635', 'cui_str': 'Mouth breathing'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001428', 'cui_str': 'Adenoidal structure'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}]",100.0,0.0279045,"After 3 months of treatment, group I showed significant better scores of main symptoms than group II; (P = 0.001),","[{'ForeName': 'Aboubakr Elshafey', 'Initials': 'AE', 'LastName': 'Ras', 'Affiliation': 'Department of Otorhinolaryngology, Benha Faculty of Medicine, Benha University, Egypt.'}, {'ForeName': 'Mona Hosny', 'Initials': 'MH', 'LastName': 'Hamed', 'Affiliation': 'Department of Otorhinolaryngology, Benha Faculty of Medicine, Benha University, Egypt.'}, {'ForeName': 'Abdelrahman Ahmed', 'Initials': 'AA', 'LastName': 'Abdelalim', 'Affiliation': 'Department of Otorhinolaryngology, Benha Faculty of Medicine, Benha University, Egypt. Electronic address: abdelrahman.ahmed@fmed.bu.edu.eg.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102723']
2175,32950853,Supporting coordination of children with ASD using neurological music therapy: A pilot randomized control trial comparing an elastic touch-display with tambourines.,"AIM


To evaluate the efficacy of Neurologic Music Therapy (NMT) using a traditional and a technological intervention (elastic touch-display) in improving the coordination of children with Autism Spectrum Disorder (ASD), as a primary outcome, and the timing and strength control of their movements as secondary outcomes.
METHODS


Twenty-two children with ASD completed 8 NMT sessions, as a part of a 2-month intervention. Participants were randomly assigned to either use an elastic touch-display (experimental group) or tambourines (control group). We conducted pre- and post- assessment evaluations, including the Developmental Coordination Disorder Questionnaire (DCDQ) and motor assessments related to the control of strength and timing of movements.
OUTCOMES AND RESULTS


All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention. Participants who used the elastic touch-display scored higher on the DCDQ.
CONCLUSIONS AND IMPLICATIONS


NMT is an efficacious treatment to improve the coordination skills of children with ASD. Elastic touch-displays provide more benefits than the use of tambourines.",2020,"All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention.","['children with Autism Spectrum Disorder (ASD', 'children with ASD', 'Twenty-two children with ASD completed 8 NMT sessions, as a part of a 2-month intervention', 'Participants who used the elastic touch-display scored higher on the DCDQ']","['Neurologic Music Therapy (NMT', 'elastic touch-display (experimental group) or tambourines (control group', 'technological intervention (elastic touch-display', 'neurological music therapy', 'elastic touch-display with tambourines']",['Developmental Coordination Disorder Questionnaire (DCDQ) and motor assessments related to the control of strength and timing of movements'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",22.0,0.0293978,"All participants improved their coordination, according to the DCDQ scores, and exhibited better control of their movements according to the strength and timing assessments after the intervention.","[{'ForeName': 'Franceli L', 'Initials': 'FL', 'LastName': 'Cibrian', 'Affiliation': 'Fowler School of Engineering, Chapman University, Orange California, USA. Electronic address: cibrian@chapman.edu.'}, {'ForeName': 'Melisa', 'Initials': 'M', 'LastName': 'Madrigal', 'Affiliation': 'CETYS Universidad, Tijuana, Mexico. Electronic address: melisa.madrigal@cetys.edu.mx.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Avelais', 'Affiliation': 'CETYS Universidad, Tijuana, Mexico. Electronic address: marina.alvelais@cetys.mx.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tentori', 'Affiliation': 'Computer Science Department, Center for Scientific Research and Higher Education of Ensenada (CICESE), Mexico. Electronic address: mtentori@cicese.mx.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103741']
2176,32950885,First night effect on polysomnographic sleep bruxism diagnosis varies among young subjects with different degrees of rhythmic masticatory muscle activity.,"OBJECTIVE


This study investigated the first night effect on the polysomnographic diagnosis of sleep bruxism (SB).
METHODS


Polysomnographic recordings were performed for two consecutive nights in forty-three subjects (mean age 23.7 ± 0.32 years [range: 20.0-33.0]). Sleep variables and rhythmic masticatory muscle activity (RMMA) were scored for two nights. The diagnosis of SB was graded by the frequency of RMMA with cut-off values of two and four times per hour of sleep.
RESULTS


Participants were classified into control (n = 15), low (n = 13) and moderate-high (n = 15) groups. Among the three groups, the concordance of the SB diagnosis was compared between the two nights. Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals. The frequency of RMMA significantly increased from the first to the second night in the moderate-high SB group only. The concordance rate of the severity between the two nights was 93.3% (14/15) in the control group, 76.9% (10/13) in the low SB group and 60% (9/15) in the moderate-high SB group. When the severity was determined on the first night, it remained the same on the second night in 77.8% (14/18) of the control group, 66.7% (10/15) of the low SB group and 90.0% (9/10) of the moderate-high SB group.
CONCLUSION


The results showed that the first night effect on the occurrence of RMMA differed among the different degrees of the RMMA frequency, and suggest that, due to the first night effect, single-night polysomnography may underestimate the moderate-high level of SB but differentiate the low level of SB from controls.",2020,"Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals.","['Polysomnographic recordings were performed for two consecutive nights in forty-three subjects (mean age 23.7\xa0±\xa00.32 years [range: 20.0-33.0', 'young subjects with different degrees of rhythmic masticatory muscle activity', 'Participants were classified into control (n\xa0=\xa015), low (n\xa0=\xa013) and moderate-high (n\xa0=\xa015) groups']",[],"['concordance of the SB diagnosis', 'sleep efficiency, longer sleep latency and higher frequency of arousals', 'Sleep variables and rhythmic masticatory muscle activity (RMMA', 'occurrence of RMMA', 'frequency of RMMA', 'polysomnographic diagnosis of sleep bruxism (SB', 'concordance rate of the severity']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517448', 'cui_str': '0.32'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0751771', 'cui_str': 'Nocturnal Teeth Grinding Disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0024890', 'cui_str': 'Structure of muscle of mastication'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0114225,"Sleep variables showed a significant first-night effect with lower sleep efficiency, longer sleep latency and higher frequency of arousals.","[{'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Haraki', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Tsujisaka', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Toyota', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Oral Rehabilitation, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, Osaka University Graduate School of Dentistry, 1-8, Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Adachi', 'Affiliation': 'Health and Counseling Center, Osaka University, 1-17 Machikaneyama-Cho, Toyonaka, Osaka, 560-0043, Japan; Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Ishigaki', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yatani', 'Affiliation': 'Department of Fixed Prosthodontics, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Taniike', 'Affiliation': 'Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan; Osaka University, United Graduate School of Child Development, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Osaka University Hospital, Sleep Medicine Center, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan; Osaka University, United Graduate School of Child Development, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Oral Physiology, Osaka University Graduate School of Dentistry, 1-8 Yamadaoka, Suita, Osaka, 565-0871, Japan. Electronic address: takafumi@dent.osaka-u.ac.jp.'}]",Sleep medicine,['10.1016/j.sleep.2020.08.012']
2177,32950893,Smartphone based behavioral therapy for pain in multiple sclerosis (MS) patients: A feasibility acceptability randomized controlled study for the treatment of comorbid migraine and ms pain.,"BACKGROUND


Multiple Sclerosis (MS) and Migraine are comorbid neurologic conditions. Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
OBJECTIVE


We sought to conduct a pilot feasibility and acceptability study of the RELAXaHEAD app in MS-Migraine patients and to assess whether there was any change in migraine disability and MS pain-related disability.
METHODS


Randomized controlled study of patients with MS-migraine ages 18-80 years with 4+ headache days/ month who were willing to engage in smartphone based behavioral therapy. Half received the RELAXaHEAD app with progressive muscle relaxation (PMR) and the other half received the app without the PMR. Data was collected for 90 days on measures of recruitment, retention, engagement, and adherence to RELAXaHEAD. Preliminary data was also collected on migraine disability (MIDAS) and MS pain (PES).
RESULTS


Sixty-two subjects with MS-migraine were enrolled in the study (34 in PMR arm, 28 in monitored usual care arm). On average, during the 90 days, participants played the PMR on average 1.8 times per week, and for 12.9 min on days it was played. Forty-one percent (14/34) of the participants played the PMR two or more times weekly on average. Data was entered into the daily diaries, on average, 49% (44/90) of the days. There were major challenges in reaching subjects in follow-up for the efficacy data, and there was no significant change in migraine disability (MIDAS) scores or MS Pain (PES) scores from baseline to the endpoints. During the six-month follow-up, most patients felt either positively or neutral about the relaxation therapy.
CONCLUSION


There was interest in scalable accessible forms of behavioral therapy to treat migraine and MS-related pain in patients with MS and comorbid migraine. Similar to prior studies, a significant minority were willing to practice the PMR at least twice weekly. In the societal shift from telephone to more text and internet-based interactions, follow up was challenging, but those reached indicated that they appreciated the PMR and would recommend it to others. Future work should focus on engagement and efficacy.",2020,"Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
","['patients with MS-migraine ages 18-80 years with 4+ headache days/ month who were willing to engage in smartphone based behavioral therapy', 'Sixty-two subjects with MS-migraine were enrolled in the study (34 in PMR arm, 28 in monitored usual care arm', 'pain in multiple sclerosis (MS) patients']","['RELAXaHEAD app with progressive muscle relaxation (PMR', 'RELAXaHEAD', 'Smartphone based behavioral therapy']","['migraine disability and MS pain-related disability', 'recruitment, retention, engagement, and adherence to RELAXaHEAD', 'migraine disability (MIDAS) scores or MS Pain (PES) scores', 'migraine disability (MIDAS) and MS pain (PES', 'Migraine prevalence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",62.0,0.022569,"Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine.
","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'NYU Langone Health, Department of Neurology, 222 E 41st, Ninth floor, New York, NY, 10017. Electronic address: mia.minen@nyulangone.org.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Schaubhut', 'Affiliation': 'Columbia University, Post-baccalaureate Premed Program, 408 Lewisohn Hall, 2970 Broadway, New York, NY 10027.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Morio', 'Affiliation': 'Columbia University, Post-baccalaureate Premed Program, 408 Lewisohn Hall, 2970 Broadway, New York, NY 10027.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102489']
2178,32950920,The effect of marker size on three-dimensional motion analysis of the foot.,"BACKGROUND


In the field of three-dimensional motion analysis of the foot, there is little agreement on the preferred size of markers to record kinematic parameters. Although currently applied marker sizes show a considerable range, there has been no detailed investigation of the effect of marker size on the calculation of foot kinematics in the current literature.
RESEARCH QUESTION


The objective of this research was to determine whether marker size impacts essential parameters that describe foot biomechanics.
METHODS


Seventeen subjects participated in this randomized repeatability study. All participants had to walk on a treadmill twice to test two sets of markers (set A: small marker, 9.5 mm, 1 g; set B: large marker, 14 mm, 2 g). Three-dimensional motion capturing was used to record the trajectories of the markers. The spatial relation of the markers, as well as vertical motion of the navicular bone and the angle of the medial longitudinal arch were calculated based on the marker trajectories. In addition to motion capturing, skin rigidity was quantified by applying an oscillatory shear force to the skin. Analysis of variance, root-mean-square error calculations and linear fit methods were applied to evaluate effects of marker size on the calculation of foot kinematics and the impact of skin rigidity.
RESULTS


The estimated foot kinematics appeared to be unaffected by the size of the markers. Further, there was no evidence that skin rigidity influenced the error of the marker trajectories. Interestingly, the large markers fell off more frequently.
SIGNIFICANCE


The findings will be of interest to those who use marker-based three-dimensional motion capturing, especially to analyze foot biomechanics. Although the calculation of kinematic parameters appears to be unaffected by marker size, practical aspects, like accidental marker loss, favor the application of small markers.",2020,The estimated foot kinematics appeared to be unaffected by the size of the markers.,['Seventeen subjects participated'],[],"['estimated foot kinematics', 'skin rigidity']","[{'cui': 'C0450331', 'cui_str': '17'}]",[],"[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}]",17.0,0.0404244,The estimated foot kinematics appeared to be unaffected by the size of the markers.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ebrecht', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany. Electronic address: florian.ebrecht@hsw.tu-chemnitz.de.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Sichting', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.007']
2179,32950939,Feasibility and efficacy of a digital CBT intervention for symptoms of Generalized Anxiety Disorder: A randomized multiple-baseline study.,"BACKGROUND AND OBJECTIVES


Cognitive behavioral therapy (CBT) is a first-line treatment for anxiety, but it is not widely available as clinical guidelines recommend. We examined the feasibility and efficacy of a novel smartphone-based fully automated digital CBT intervention, 'Daylight™', to improve symptoms of Generalized Anxiety Disorder (GAD).
METHODS


In this multiple-baseline design, 21 adults (20 F; mean age 43yrs. range 19-65yrs.) with moderate-to-severe symptoms of GAD were randomized to one of three baseline durations (2-, 4-, or 6-weeks) and then received access to digital CBT. Participants completed daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up.
RESULTS


Digital CBT was found to be feasible in terms of engagement, satisfaction, and safety. For preliminary efficacy, improvements were detected in daily and weekly outcomes of anxiety for most participants. Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline. Overall, 70% of participants no longer had clinically significant symptoms of GAD, 61% no longer had significant depressive symptoms, and 40% no longer had significant sleep difficulty at post-intervention.
LIMITATIONS


The study sample was recruited using the internet and was mostly female, limiting the generalizability of the findings.
CONCLUSIONS


Findings support the feasibility and efficacy of Daylight. Further examination in randomized controlled trials is now warranted.",2020,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","['21 adults (20\xa0F; mean age 43yrs', 'range 19-65yrs.) with moderate-to-severe symptoms of GAD', 'Generalized Anxiety Disorder']","['digital CBT intervention', ""novel smartphone-based fully automated digital CBT intervention, 'Daylight™"", 'Cognitive behavioral therapy (CBT']","['depressive symptoms', 'daily ratings of anxiety and worry, weekly measures of anxiety, depressive symptoms, and sleep, and measures of anxiety, worry, wellbeing, quality of life, CBT skill acquisition, and work performance at initial assessment prior to baseline randomization, post-intervention, and follow-up', 'Feasibility and efficacy', 'engagement, satisfaction, and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",21.0,0.0552773,"Despite individual differences, significant improvements occurred with the introduction of digital CBT and not during baseline.","[{'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK. Electronic address: chris.miller@bighealth.com.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Davis', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, Sir William Dunn School of Pathology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stott', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK; University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Adrienne J', 'Initials': 'AJ', 'LastName': 'Heinz', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}, {'ForeName': 'Kate H', 'Initials': 'KH', 'LastName': 'Bentley', 'Affiliation': 'Derner School of Psychology, Adelphi University, Garden City, NY, USA.'}, {'ForeName': 'Guy M', 'Initials': 'GM', 'LastName': 'Goodwin', 'Affiliation': 'University Department of Psychiatry, University of Oxford and Oxford Health NHS Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Bernard S', 'Initials': 'BS', 'LastName': 'Gorman', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Anxiety and Depression Research Centre (ADRC), UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Carl', 'Affiliation': 'Big Health Inc., San Francisco, CA, USA; Big Health Inc., London, UK.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101609']
2180,32950989,"Weight Loss, Dietary Preferences, and Reduction in the Sense of Smell with the Use of a Novel Nasal Device.","INTRODUCTION


Exposure to food odors are known to increase food intake. Olfaction declines from age 50 years.
OBJECTIVE


We examined changes in the sense of smell, body weight, food preferences, and parameters of metabolic status, following the use of a specially designed nasal device.
METHODS


This is a randomized, placebo-controlled study. Participants wore a nasal device (soft silicone insert) for 5-12 h daily (device group) or inserted 2 drops of normal saline into each nostril daily (control group). Follow-up visits occurred every 2 weeks. All participants were given a 500 kcal/day reduced diet and instructed not to change their regular physical activity. Weight, food preferences, olfactory sensitivity, and blood tests were performed at baseline and after 12 weeks.
RESULTS


Of 156 participants, 65 (42%) completed the study. Sense of smell decreased in the device group (from 6.4 ± 0.9 to 4.4 ± 1.5, on a scale of 0-7, p < 0.001), and did not change in the control group. Weight loss decreased by 6.6 ± 3.7% (p = 0.001) and by 5.7 ± 3.5% (p = 0.001) in the respective groups (between-group difference, p > 0.05). Among participants aged ≤50 years, weight loss was greater in the device than in the control group (7.7 ± 4.2% vs. 4.1 ± 2.9%, p = 0.02). Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR) were significantly reduced in the device group (p = 0.02 and p = 0.01, respectively), but not in the control group. Food preferences for sugar (p < 0.02), sweet beverages (p < 0.001), and artificial sweeteners (p < 0.02) were significantly reduced in the device group compared to the control group.
CONCLUSIONS


The use of a novel self-administrated nasal device led to reduced olfactory sensitivity, improved insulin sensitivity, weight loss, and lesser preference for sweets in adults aged ≤50 years.",2020,"Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR) were significantly reduced in the device group (p = 0.02 and p = 0.01, respectively), but not in the control group.","['Of 156 participants, 65 (42%) completed the study', 'adults aged ≤50 years']","['placebo', 'nasal device (soft silicone insert) for 5-12 h daily (device group) or inserted 2 drops of normal saline into each nostril daily (control group']","['Weight, food preferences, olfactory sensitivity, and blood tests', 'weight loss', 'artificial sweeteners', 'insulin sensitivity, weight loss, and lesser preference for sweets', 'Sense of smell', 'Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR', 'sweet beverages', 'Weight Loss, Dietary Preferences, and Reduction in the Sense of Smell', 'Weight loss']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0003920', 'cui_str': 'Artificial sweetener'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",,0.0873482,"Insulin level and the homeostatic model assessment of insulin resistance (HOMA-IR) were significantly reduced in the device group (p = 0.02 and p = 0.01, respectively), but not in the control group.","[{'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Dicker', 'Affiliation': 'Internal Medicine D and Obesity Clinic, Hasharon Hospital, Rabin Medical Center, Petach-Tikva, Israel, daniel3@013.net.'}, {'ForeName': 'Adva', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Beck Medical, Givat-Ada, Israel.'}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Markel', 'Affiliation': 'Haemek Medical Center, Afula, Israel.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Marcovicu', 'Affiliation': 'Internal Medicine D and Obesity Clinic, Hasharon Hospital, Rabin Medical Center, Petach-Tikva, Israel.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Mazzawi', 'Affiliation': 'Otolaryngology Head and Neck Surgery, Haemek Medical Center, Rappaport School of Medicine, Technion, Israel.'}, {'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Sarid', 'Affiliation': 'Western Galilee College, Akko, Israel.'}, {'ForeName': 'Elhanan', 'Initials': 'E', 'LastName': 'Greenberg', 'Affiliation': 'Beck Medical, Givat-Ada, Israel.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Atkinson', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.'}]",Obesity facts,['10.1159/000508976']
2181,32951002,The effect of intranasal oxytocin on visual processing and salience of human faces.,"The mechanisms underlying the role of oxytocin (OT) as a regulator of social behavior in mammals are only partly understood. Recently, it has been proposed that OT increases the salience of social stimuli. We carried out a randomized, double-blind, cross-over study of the effects of OT on binocular rivalry, a visual phenomenon underpinned by the interplay of excitation and inhibition in the cortex. A final sample of 45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches). We demonstrate a robust effect that intranasal OT increases the salience of human faces in binocular rivalry, such that dominance durations of faces are longer-this effect is not modulated by the facial expression. We tentatively show that OT treatment increases dominance durations for non-social stimuli. Our results lend support to the social salience hypothesis of OT, and in addition offer provisional support for the role of OT in influencing excitation-inhibition balance in the brain.",2020,A final sample of 45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches).,['45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches'],"['OT', 'intranasal OT', 'intranasal oxytocin', 'oxytocin (OT']",['visual processing and salience of human faces'],"[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0589087', 'cui_str': 'Visual processing'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",45.0,0.0455496,A final sample of 45 participants viewed images of social stimuli (faces with different emotional expressions) and non-social stimuli (houses and Gabor patches).,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hovey', 'Affiliation': 'Department of Pharmacology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. daniel.hovey@neuro.gu.se.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Martens', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laeng', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Leknes', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Westberg', 'Affiliation': 'Department of Pharmacology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Translational psychiatry,['10.1038/s41398-020-00991-3']
2182,32951067,"A specific dietary fibre supplementation improves cognitive performance-an exploratory randomised, placebo-controlled, crossover study.","RATIONALE


The impact of the microbiota on the gut-brain axis is increasingly appreciated. A growing body of literature demonstrates that use of dietary fibre and prebiotics can manipulate the microbiota and affect host health. However, the influence on cognition and acute stress response is less well understood.
OBJECTIVES


The objective of this study was to investigate the efficacy of a dietary fibre, polydextrose (PDX), in improving cognitive performance and acute stress responses through manipulation of the gut microbiota in a healthy population.
METHODS


In this double-blind, randomised, placebo-controlled, crossover design study, 18 healthy female participants received 12.5 g Litesse®Ultra (> 90% PDX polymer) or maltodextrin for 4 weeks. Cognitive performance, mood, acute stress responses, microbiota composition, and inflammatory markers were assessed pre- and post-intervention.
RESULTS


PDX improved cognitive flexibility as evidenced by the decrease in the number of errors made in the Intra-Extra Dimensional Set Shift (IED) task. A better performance in sustained attention was observed through higher number of correct responses and rejections in the Rapid Visual Information Processing (RVP) task. Although there was no change in microbial diversity, abundance of Ruminiclostridium 5 significantly increased after PDX supplementation compared with placebo. PDX supplementation attenuated the increase of adhesion receptor CD62L on classical monocytes observed in the placebo group.
CONCLUSIONS


Supplementation with the PDX resulted in a modest improvement in cognitive performance. The results indicate that PDX could benefit gut-to-brain communication and modulate behavioural responses.",2020,A better performance in sustained attention was observed through higher number of correct responses and rejections in the Rapid Visual Information Processing (RVP) task.,"['18 healthy female participants received 12.5 g', 'healthy population']","['PDX supplementation', 'Litesse®Ultra (> 90% PDX polymer) or maltodextrin', 'PDX', 'placebo', 'specific dietary fibre supplementation', 'dietary fibre, polydextrose (PDX']","['cognitive performance', 'cognition and acute stress response', 'Cognitive performance, mood, acute stress responses, microbiota composition, and inflammatory markers', 'adhesion receptor CD62L on classical monocytes', 'cognitive flexibility', 'microbial diversity, abundance of Ruminiclostridium']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0071545', 'cui_str': 'polydextrose'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439083', 'cui_str': '>90'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0556106', 'cui_str': 'Dietary fiber supplementation'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0300500', 'cui_str': 'adhesion receptor'}, {'cui': 'C0125090', 'cui_str': 'Lymphocyte antigen CD62L'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",18.0,0.23149,A better performance in sustained attention was observed through higher number of correct responses and rejections in the Rapid Visual Information Processing (RVP) task.,"[{'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Berding', 'Affiliation': 'APC Microbiome Ireland, University College Cork, Cork, Ireland.'}, {'ForeName': 'Caitriona M', 'Initials': 'CM', 'LastName': 'Long-Smith', 'Affiliation': 'APC Microbiome Ireland, University College Cork, Cork, Ireland.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Carbia', 'Affiliation': 'APC Microbiome Ireland, University College Cork, Cork, Ireland.'}, {'ForeName': 'Thomaz F S', 'Initials': 'TFS', 'LastName': 'Bastiaanssen', 'Affiliation': 'APC Microbiome Ireland, University College Cork, Cork, Ireland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'van de Wouw', 'Affiliation': 'APC Microbiome Ireland, University College Cork, Cork, Ireland.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Wiley', 'Affiliation': 'APC Microbiome Ireland, University College Cork, Cork, Ireland.'}, {'ForeName': 'Conall R', 'Initials': 'CR', 'LastName': 'Strain', 'Affiliation': 'APC Microbiome Ireland, University College Cork, Cork, Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Fouhy', 'Affiliation': 'APC Microbiome Ireland, University College Cork, Cork, Ireland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stanton', 'Affiliation': 'APC Microbiome Ireland, University College Cork, Cork, Ireland.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Cryan', 'Affiliation': 'APC Microbiome Ireland, University College Cork, Cork, Ireland. j.cryan@ucc.ie.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Dinan', 'Affiliation': 'APC Microbiome Ireland, University College Cork, Cork, Ireland.'}]",Psychopharmacology,['10.1007/s00213-020-05665-y']
2183,32951084,Tolerability and toxicity of trastuzumab or trastuzumab + lapatinib in older patients: a sub-analysis of the ALTTO trial (BIG 2-06; NCCTG (Alliance) N063D).,"PURPOSE


Little is known about the use of trastuzumab or trastuzumab + lapatinib in older patients. We have performed a sub-analysis of the Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation (ALTTO) trial focused on toxicity and treatment completion of both regimens in older patients (≥ 65 years old) METHODS: The ALTTO trial randomised 8381 patients with early HER2-positive BC in 4 arms. Eligible patients for this study were those having received at least one dose of assigned treatment in either the trastuzumab or trastuzumab + lapatinib arms. Treatment completion was evaluated through the rate of temporary treatment interruptions, permanent treatment discontinuations and lapatinib dose reductions. Toxicity was evaluated via a selected subset of adverse events of interest (AEI). Risk factors for both treatment completion outcomes and toxicity were investigated, including comorbidities and use of 5 or more co-medications at randomization.
RESULTS


A total of 430 patients ≥ 65 year were eligible. Median age was 68 (range 65-80). In comparison with the younger cohort, older patients had a significantly higher number of comorbidities at randomization (p < 0.001). Treatment completion outcomes were worse, particularly in the trastuzumab + lapatinib arm. Adverse events of interest were likewise more common in the trastuzumab + lapatinib arm with higher AEI rates (63.4% in younger vs 78.0% in older, p < 0.001). Concomitant chemotherapy was associated with worse treatment completion outcomes among older patients.
CONCLUSION


Trastuzumab plus lapatinib was significantly more toxic among older patients and had worse treatment completion. Trastuzumab was generally well tolerated.",2020,"In comparison with the younger cohort, older patients had a significantly higher number of comorbidities at randomization (p < 0.001).","['65\xa0year were eligible', 'Median age was 68 (range 65-80', 'older patients (≥', '430 patients\u2009≥', 'older patients', '8381 patients with early HER2-positive BC in 4 arms']","['Concomitant chemotherapy', 'trastuzumab or trastuzumab\u2009+\u2009lapatinib', 'Trastuzumab', 'Lapatinib', 'Trastuzumab plus lapatinib']","['toxic', 'Toxicity', 'Tolerability and toxicity', 'toxicity', 'number of comorbidities', 'tolerated', 'AEI rates']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",8381.0,0.162948,"In comparison with the younger cohort, older patients had a significantly higher number of comorbidities at randomization (p < 0.001).","[{'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Pondé', 'Affiliation': 'AC Camargo Cancer Center, Rua Pires da Mota, 1167, São Paulo, 01529-001, Brazil. noam.ponde@accamargo.org.br.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Agbor-Tarh', 'Affiliation': 'Frontier Science Scotland (FSS), Kincraig, UK.'}, {'ForeName': 'Lissandra', 'Initials': 'L', 'LastName': 'Dal Lago', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Larissa A', 'Initials': 'LA', 'LastName': 'Korde', 'Affiliation': 'National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Florentine', 'Initials': 'F', 'LastName': 'Hilbers', 'Affiliation': 'Breast International Group, Brussels, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum, Offenbach, Germany.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Werner', 'Affiliation': 'Novartis, Basel-City, Switzerland.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'Aminah', 'Initials': 'A', 'LastName': 'Jatoi', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Sotiriou', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05915-9']
2184,32951121,Herbal medicines as anxiolytics prior to third molar surgical extraction. A randomized controlled clinical trial.,"OBJECTIVES


This study aimed to compare the effects of Passiflora incarnata, Erythrina mulungu, and midazolam in controlling anxiety in patients undergoing mandibular third molar extraction.
METHODS


The volunteers underwent extraction of their third mandibular molars in a randomized, placebo-controlled, triple-blind, and parallel clinical trial. Passiflora incarnata (500 mg), Erythrina mulungu (500 mg), or midazolam (15 mg) was orally administered 60 min before the surgery. The anxiety level of participants was evaluated using questionnaires and measurements of physical parameters, including heart rate (HR), blood pressure (BP), and oxygen saturation (SpO 2 ).
RESULTS


A total of 200 volunteers were included in this clinical trial. Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO 2  were observed among the protocols.
CONCLUSIONS


Passiflora incarnata showed a similar effect to midazolam but differed from placebo and mulungu, which were unable to control anxiety in this situation. Therefore, the results suggest that Passiflora configures an herbal medicine with an anxiolytic effect, adequate to use in third molar extractions.
CLINICAL RELEVANCE


The use of Passiflora incarnata may be an alternative to benzodiazepines for controlling anxiety in patients scheduled for oral surgery under local anesthesia.
TRIAL REGISTRATION


ClinicalTrials.gov : ANSI-388.427.",2020,"Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO 2  were observed among the protocols.
","['200 volunteers', 'patients scheduled for oral surgery under local anesthesia', 'patients undergoing mandibular third molar extraction']","['Passiflora incarnata, Erythrina mulungu, and midazolam', 'benzodiazepines', 'Passiflora incarnata (500 mg), Erythrina mulungu', 'Herbal medicines', 'placebo', 'midazolam']","['heart rate (HR), blood pressure (BP), and oxygen saturation (SpO 2 ', 'BP, HR, and SpO 2', 'anxiety level']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C2919980', 'cui_str': 'passiflora incarnata flowering top extract'}, {'cui': 'C4042780', 'cui_str': 'Erythrina mulungu'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",200.0,0.364556,"Considering each procedure independently, no significant differences (p > 0.05) in BP, HR, and SpO 2  were observed among the protocols.
","[{'ForeName': 'Rafael Soares', 'Initials': 'RS', 'LastName': 'da Cunha', 'Affiliation': 'Oral Surgery and Anesthesiology Area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}, {'ForeName': 'Klinger Souza', 'Initials': 'KS', 'LastName': 'Amorim', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, Av. Limeira, 901, Areião, Piracicaba, São Paulo, 13414-903, Brazil. klinger.amorim@outlook.com.'}, {'ForeName': 'Anne Caroline', 'Initials': 'AC', 'LastName': 'Gercina', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, Av. Limeira, 901, Areião, Piracicaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Allan Carlos Araújo', 'Initials': 'ACA', 'LastName': 'de Oliveira', 'Affiliation': 'Oral Surgery and Anesthesiology Area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}, {'ForeName': 'Liciane', 'Initials': 'L', 'LastName': 'Dos Santos Menezes', 'Affiliation': 'Oral Surgery and Anesthesiology Area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}, {'ForeName': 'Francisco Carlos', 'Initials': 'FC', 'LastName': 'Groppo', 'Affiliation': 'Pharmacology, Anesthesiology and Therapeutics Department of the Piracicaba Dental School, University of Campinas, Av. Limeira, 901, Areião, Piracicaba, São Paulo, 13414-903, Brazil.'}, {'ForeName': 'Liane Maciel Almeida', 'Initials': 'LMA', 'LastName': 'Souza', 'Affiliation': 'Oral Surgery and Anesthesiology Area of Dentistry Department, Federal University of Sergipe, St Cláudio Batista, s/n. Cidade Nova, Aracaju, Sergipe, 49060-108, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-020-03468-1']
2185,32951151,Factors Associated with Good Patient Outcomes Following Convalescent Plasma in COVID-19: A Prospective Phase II Clinical Trial.,"INTRODUCTION


Coronavirus disease 2019 (COVID-19) is a viral respiratory syndrome caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This novel virus was discovered in Wuhan City, Hubei Province, China, in December 2019. As of September 6, 2020, confirmed cases have risen to more than 27,000,000 worldwide and more than 885,000 people have died. Currently, no cure or standard treatment for COVID-19 exists. We conducted a prospective single-arm open-label phase II clinical trial assessing the safety and efficacy of convalescent plasma in hospitalized patients with COVID-19.
METHODS


Convalescent plasma with sufficient total anti-SARS-CoV-2 IgG titer (1:320) obtained from recovered donors was administered to adult patients with either severe or critical COVID-19 illness. Primary outcomes were adverse events in association with plasma administration, and hospital mortality. Secondary outcomes included disease progression, recovery, length of stay, and hospital discharge.
RESULTS


Of the 38 patients included in the analysis, 24 (63%) recovered and were discharged, and 14 (37%) died. Patients who received convalescent plasma early in the disease course (severe illness group) as compared to the patients that received convalescent plasma later in the disease progression (critical illness group) had significantly lower hospital mortality 13% vs 55% (p < 0.02) and shorter mean hospital length of stay 15.4 vs 33 days (p < 0.01). One patient experienced a transient transfusion reaction. No other adverse effects of convalescent plasma infusion were observed.
CONCLUSIONS


Our results suggest that convalescent plasma with adequate anti-SARS-CoV-2 antibody titer is safe and has the potential for positive impact on clinical outcomes including recovery and survival if given to patients early in the course of COVID-19 disease.
TRIAL REGISTRATION


ClinicalTrials.gov. Identifier, NCT04343261, IND #19805.",2020,"No other adverse effects of convalescent plasma infusion were observed.
","['Convalescent plasma with sufficient total anti-SARS-CoV-2 IgG titer (1:320) obtained from recovered donors was administered to adult patients with either severe or critical COVID-19 illness', 'Wuhan City, Hubei Province, China, in December 2019', 'COVID-19', 'hospitalized patients with COVID-19']",[],"['adverse events in association with plasma administration, and hospital mortality', 'transient transfusion reaction', 'hospital mortality', 'safety and efficacy', 'disease progression, recovery, length of stay, and hospital discharge', 'mean hospital length of stay']","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]",[],"[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0841188,"No other adverse effects of convalescent plasma infusion were observed.
","[{'ForeName': 'Danyal', 'Initials': 'D', 'LastName': 'Ibrahim', 'Affiliation': 'Trinity Health of New England, Hartford, CT, USA. dibrahim@trinityhealthofne.org.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Dulipsingh', 'Affiliation': 'Diabetes Center, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Zapatka', 'Affiliation': 'Trinity Health of New England, Hartford, CT, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Eadie', 'Affiliation': 'Trinity Health of New England, Hartford, CT, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Crowell', 'Affiliation': 'Research Department, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Research Department, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Dorothy B', 'Initials': 'DB', 'LastName': 'Wakefield', 'Affiliation': 'Research Department, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cook', 'Affiliation': 'Diabetes Center, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Puff', 'Affiliation': 'Diabetes Center, Saint Francis Hospital, Hartford, CT, USA.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Trinity Health of New England, Hartford, CT, USA.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00341-2']
2186,32951215,Disability Prevention Program Improves Life-Space and Falls Efficacy: A Randomized Controlled Trial.,"OBJECTIVES


To evaluate the effects of a home-based disability prevention program on life-space and falls efficacy among low-income older adults.
DESIGN


Single-blind two-arm randomized controlled trial.
SETTING


Participants' homes.
PARTICIPANTS


Participants were low-income cognitively intact older adults (≥65 years old) with restricted daily activities. Our analytic sample for life-space (n = 194) and falls efficacy (n = 233) varied as the life-space measure was introduced 4 months after the trial began.
INTERVENTION


Up to six 1-hour home visits with an occupational therapist; up to four 1-hour home visits with a registered nurse; and up to $1,300 worth of home repairs, modifications, and assistive devices with a handyman, during a course of 4 months.
MEASUREMENTS


Life-space was measured by the Homebound Mobility Assessment; falls efficacy was measured using the 10-item Tinetti Falls Efficacy Scale at baseline and 5 months.
RESULTS


Participants were on average 75 years old, predominantly Black (86%) and female (85%-86%). Compared with participants in the control group, participants receiving the intervention were more likely to have improved versus decreased life-space in areas of bathroom (adjusted odds ratio (OR) = 3.95; 95% confidence interval (CI) = 1.20-12.97), front or back porch, patio, or deck (adjusted OR = 2.67; 95% CI = 1.05-6.79), stairs (adjusted OR = 4.09; 95% CI = 1.34-12.48), leaving the house for any reason other than for health care (adjusted OR = 2.40; 95% CI = 1.01-5.73), and overall life-space (adjusted OR = 2.15; 95% CI = 1.10-4.19). Participants who received the intervention also had an 11% improvement in falls efficacy in performing daily activities (exponentiated coefficient = 1.12; 95% CI = 1.04-1.21).
CONCLUSION


Life-space and falls efficacy were improved through a multicomponent, person-directed, home-based disability prevention intervention. Findings suggest that this intervention should be translated into different settings to promote independent aging.",2020,"Compared with participants in the control group, participants receiving the intervention were more likely to have improved versus decreased life-space in areas of bathroom (adjusted odds ratio (OR) = ","['low-income older adults', ""Participants' homes"", 'Participants were on average 75\u2009years old, predominantly Black (86%) and female (85%-86', 'Participants were low-income cognitively intact older adults (≥65\u2009years old) with restricted daily activities']","['home-based disability prevention program', 'Up to six 1-hour home visits with an occupational therapist; up to four 1-hour home visits with a registered nurse; and up to $1,300 worth of home repairs, modifications, and assistive devices with a handyman']","['Life-Space and Falls Efficacy', 'falls efficacy', '10-item Tinetti Falls Efficacy Scale', 'overall life-space', 'Homebound Mobility Assessment; falls efficacy', 'life-space and falls efficacy', 'Life-space']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2584445', 'cui_str': 'Tinetti falls efficacy scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242798', 'cui_str': 'Home-Bound Persons'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}]",,0.137717,"Compared with participants in the control group, participants receiving the intervention were more likely to have improved versus decreased life-space in areas of bathroom (adjusted odds ratio (OR) = ","[{'ForeName': 'Minhui', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Central South University Xiangya School of Nursing, Changsha, China.'}, {'ForeName': 'Qian-Li', 'Initials': 'QL', 'LastName': 'Xue', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Wolff', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Guralnik', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Leff', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Szanton', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16808']
2187,32951241,"Pre-mixed nitrous oxide/oxygen mixture treatment of pain induced by postoperative dressing change for perianal abscess: Study protocol for a randomized, controlled trial.","AIM


This study aims to evaluate the safety and analgesic efficacy of pre-mixed nitrous oxide/oxygen mixture treatment of pain induced by dressing change for perianal abscess.
DESIGN


This protocol is a randomized, double-blind, placebo-controlled trial.
METHODS


This study will be implemented in the Hospital of Traditional Chinese Medicine. Subjects enrolled in this study are hospitalized patients who suffered from moderate to severe pain due to dressing change after incision and drainage. Two hundred patients will be selected and randomly assigned to either an intervention or a control group. The intervention group will get routine pain treatment plus pre-mixed nitrous oxide/oxygen mixture treatment and the control group will be treated with routine pain management plus medical air treatment. All these patients, medical staff and investigators are blind to the nature of the gas in each cylinder, which is randomized. Data will be collected at baseline (T0), 5 min (T1) after the starting of intervention and 5 min post intervention (T2) for each group. The primary outcome is the level of pain relief at T1 and T2. The secondary outcomes cover physiological parameters, adverse events, satisfaction of patients and health professionals and the acceptance from patients.
DISCUSSION


Results of this study will be discussed and the safety and effect of nitrous oxide/oxygen treatment of pain induced by dressing change will be proven.
IMPACT


When the finding of this study has an active effect on the treatment of pain caused by dressing change, it may provide more options for nursing staff to choose nurse-led analgesia techniques and then improving the level and quality of pain care as well as patients' overall satisfaction with the Anorectal Department in China.",2020,"Data will be collected at baseline (T0), 5 min (T1) after the starting of intervention and 5 min post intervention (T2) for each group.","['Two hundred patients', 'pain induced by postoperative dressing change for perianal abscess', 'hospitalized patients who suffered from moderate to severe pain due to dressing change after incision and drainage']","['pre-mixed nitrous oxide/oxygen mixture treatment', 'routine pain treatment plus pre-mixed nitrous oxide/oxygen mixture treatment and the control group will be treated with routine pain management plus medical air treatment', 'nitrous oxide/oxygen', 'placebo', 'Pre-mixed nitrous oxide/oxygen mixture treatment']","['safety and analgesic efficacy', 'level of pain relief at T1 and T2', 'physiological parameters, adverse events, satisfaction of patients and health professionals and the acceptance from patients']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031019', 'cui_str': 'Perianal abscess'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0085671', 'cui_str': 'Change of dressing'}, {'cui': 'C0152277', 'cui_str': 'Incision AND drainage'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3536832', 'cui_str': 'Air'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",200.0,0.180767,"Data will be collected at baseline (T0), 5 min (T1) after the starting of intervention and 5 min post intervention (T2) for each group.","[{'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Hai-Xiang', 'Initials': 'HX', 'LastName': 'Gao', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Wen-Qiang', 'Initials': 'WQ', 'LastName': 'Bao', 'Affiliation': 'Pain Department, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Jing-Yang', 'Initials': 'JY', 'LastName': 'Mou', 'Affiliation': 'TCM clinic of Puji Pharmacy, Yinchuan, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Meng', 'Affiliation': 'Anorectal Department, Yinchuan Hospital of Traditional Chinese Medicine affiliated to Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ya-Liang', 'Initials': 'YL', 'LastName': 'Dai', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Gao', 'Affiliation': 'School of Public Health and Management, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'School of Basic Medical Sciences, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'Li', 'Affiliation': 'Anorectal Department, Yinchuan Hospital of Traditional Chinese Medicine affiliated to Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Ge', 'Affiliation': 'Anorectal Department, Yinchuan Hospital of Traditional Chinese Medicine affiliated to Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Anorectal Department, Yinchuan Hospital of Traditional Chinese Medicine affiliated to Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Jian-Qiang', 'Initials': 'JQ', 'LastName': 'Yu', 'Affiliation': 'Department of Pharmacology, Pharmaceutical Institute of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yu-Xiang', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}]",Journal of advanced nursing,['10.1111/jan.14515']
2188,32951292,"Comparative evaluation of Gracilaria algae 3% cream versus Clobetasol 0.05% cream in treatment of plaque type psoriasis; A Randomized, split-body, triple-blinded clinical trial.","BACKGROUND


Gracilaria algae is red macro algae which has demonstrated considerable anti-inflammatory effects. Our objective was to compare the efficacy of Gracilaria algae topical cream 3% versus Clobetasol cream 0.05% in treatment of plaque-type psoriasis.
MATERIAL AND METHODS


30 adult patients with baseline modified PASI score ≤12 were randomized to receive either Clobetasol or Gracilaria algae cream on right or left-sided symmetric plaques once daily for 8 weeks and follow-up of 4 weeks. Modified PASI score, patient's satisfaction using VAS and Global Physician Assessment score (GPA) were assessed to evaluate clinical response.
RESULTS


30 patients with 94 symmetrical psoriasis plaques were enrolled in this trial. The mean baseline modified PASI score of both sides was similar; however, at the end of trial, modified PASI score was reduced more on the sides treated with Gracilaria algae cream (0.80±0.19% vs. 0.63±0.25%, P<0.05). No significant difference was found regarding Mean Physician Global Assessment score (PGA) between the 2 groups (p>0.05). Patients' satisfaction was significantly higher in favor of algae cream only at week 8 of the intervention (P<0.05).
CONCLUSION


Gracilaria algae cream can be an effective and safe alternative of Clobetasol in the treatment of plaque type psoriasis. This article is protected by copyright. All rights reserved.",2020,No significant difference was found regarding Mean Physician Global Assessment score (PGA) between the 2 groups (p>0.05).,"['plaque-type psoriasis', '30 patients with 94 symmetrical psoriasis plaques', '30 adult patients with baseline modified PASI score ≤12']","['Gracilaria algae topical cream', 'Clobetasol cream', 'Gracilaria algae 3% cream versus Clobetasol 0.05% cream', 'Clobetasol or Gracilaria algae cream on right or left-sided symmetric plaques once daily for 8\u2009weeks and follow-up of 4\u2009weeks', 'Gracilaria algae cream']","[""Modified PASI score, patient's satisfaction using VAS and Global Physician Assessment score (GPA"", 'modified PASI score', 'plaque type psoriasis', 'mean baseline modified PASI score', 'Mean Physician Global Assessment score (PGA']","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1092970', 'cui_str': 'Gracilaria'}, {'cui': 'C0002028', 'cui_str': 'Algae'}, {'cui': 'C0991551', 'cui_str': 'Cutaneous cream'}, {'cui': 'C0008992', 'cui_str': 'Clobetasol'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",30.0,0.0624814,No significant difference was found regarding Mean Physician Global Assessment score (PGA) between the 2 groups (p>0.05).,"[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Shatalebi', 'Affiliation': 'Novel Drug Delivery Systems Research Center, Department of Pharmaceutics, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Safoura Bokaie', 'Initials': 'SB', 'LastName': 'Jazi', 'Affiliation': 'Novel Drug Delivery Systems Research Center, Department of Pharmaceutics, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Yegdaneh', 'Affiliation': 'Department of Pharmacognosy, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Iraji', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir Hossein', 'Initials': 'AH', 'LastName': 'Siadat', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pegah', 'Initials': 'P', 'LastName': 'Noorshargh', 'Affiliation': 'Alzahra Hospital Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Dermatologic therapy,['10.1111/dth.14317']
2189,32951301,Effect of vitamin D supplementation versus placebo on essential hypertension in patients with vitamin D deficiency: a double-blind randomized clinical trial.,"Findings from randomized trials addressing the effect of vitamin D supplementation and blood pressure are inconsistent and have been the subject of recent debate. This study aimed to assess the effect of vitamin D supplementation on primary hypertension. This double-blind randomized clinical trial was conducted on patients aged 26-84 years with essential hypertension from March 2017 to April 2019. Patients with vitamin D insufficiency (serum vitamin D levels 20-30 ng/ml) or vitamin D deficiency (serum vitamin D levels <20 ng/ml) were enrolled in the study. Patients were randomly assigned to receive vitamin D supplementation or placebo. Systolic and diastolic blood pressure was measured before the intervention and one and two months thereafter. Of 208 patients enrolled, 171 patients remained for analysis. The effect of vitamin D supplementation on systolic blood pressure was statistically significant in the first and second months after the intervention (P=0.004 and P=0.024, respectively). The effect of vitamin D supplementation on diastolic blood pressure was statistically significant in the first month after the intervention (P=0.046), but not in the second month (P=0.885). No evidence of drug side effects was reported in the two groups. The results of this trial are suggestive of the potential benefits of vitamin D supplementation on blood pressure end points. Therefore, the use of vitamin D may be recommended as an adjuvant drug in the treatment of essential hypertension in patients with vitamin D deficiency because it is safe and well-tolerated by the patients and can significantly reduce the systolic and diastolic blood pressure. Trial registration: Iranian Registry of Clinical Trials registration number: IRCT201703129014N151.",2020,No evidence of drug side effects was reported in the two groups.,"['Patients with vitamin D insufficiency (serum vitamin D levels 20-30 ng/ml) or vitamin D deficiency (serum vitamin D levels <20 ng/ml) were enrolled in the study', '208 patients enrolled, 171 patients remained for analysis', 'patients aged 26-84 years with essential hypertension from March 2017 to April 2019', 'patients with vitamin D deficiency', 'primary hypertension']","['vitamin D supplementation', 'vitamin D supplementation or placebo', 'placebo', 'vitamin D']","['systolic and diastolic blood pressure', 'Systolic and diastolic blood pressure', 'systolic blood pressure', 'essential hypertension', 'diastolic blood pressure', 'blood pressure end points']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444930', 'cui_str': 'End'}]",208.0,0.483737,No evidence of drug side effects was reported in the two groups.,"[{'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Sheikh', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Mozaianimonfared', 'Affiliation': 'Department of Cardiology, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Gharakhani', 'Affiliation': 'Department of Cardiology, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Poorolajal', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Ph D', 'Affiliation': 'Department of Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13926']
2190,32951335,Effects of 8 weeks of bed rest with or without resistance exercise intervention on the volume of the muscle tissue and the adipose tissues of the thigh.,"The present study aims to investigate the effects of 8 weeks of bed rest, with or without resistance exercise intervention, on the volumes of muscle tissue and the intramuscular, intermuscular, and subcutaneous adipose tissues of the thigh. Twenty men were included, who were randomly assigned in three groups: resistance exercises group (RE group), resistance exercises with whole-body vibration group (VRE group), and nonexercise control group (CTR group). The RE and VRE groups performed resistance exercises during 8 weeks of bed rest (3 days per week). Additionally, consecutive axial magnetic resonance images were obtained before and after the bed rest. Using these images, the volumes of the muscle tissue and the intramuscular adipose tissue, intermuscular adipose tissue, and subcutaneous adipose tissue of the thigh were evaluated. No significant time-by-group interaction was observed the volumes of the muscle tissue and the intramuscular adipose tissue, intermuscular adipose tissue, and subcutaneous adipose tissue between the RE and VRE groups. Furthermore, the RE and VRE groups were pooled as the resistance exercise intervention group (TR group), wherein their thigh muscle tissue volume was observed to be maintained after the bed rest. However, that of the CTR group significantly decreased. Regarding the thigh intramuscular adipose tissue and intermuscular adipose tissue volumes, no significant difference was observed among the CTR and TR groups. Although subcutaneous adipose tissue volume in the CTR group significantly increased after the bed rest, no changes were observed in that of the TR group. Therefore, the results of the present study suggested that within the 8 weeks of bed rest, adipose tissue adaptation differs depending on the location.",2020,"No significant time-by-group interaction was observed the volumes of the muscle tissue and the intramuscular adipose tissue, intermuscular adipose tissue, and subcutaneous adipose tissue between the RE and VRE groups.",['Twenty men'],"['resistance exercises group (RE group), resistance exercises with whole-body vibration group (VRE group), and nonexercise control group (CTR group', 'resistance exercise intervention', 'bed rest with or without resistance exercise intervention', 'bed rest, with or without resistance exercise intervention', 'CTR']","['subcutaneous adipose tissue volume', 'thigh muscle tissue volume', 'volumes of the muscle tissue and the intramuscular adipose tissue, intermuscular adipose tissue, and subcutaneous adipose tissue', 'volume of the muscle tissue and the adipose tissues of the thigh', 'thigh intramuscular adipose tissue and intermuscular adipose tissue volumes']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}]",20.0,0.0179595,"No significant time-by-group interaction was observed the volumes of the muscle tissue and the intramuscular adipose tissue, intermuscular adipose tissue, and subcutaneous adipose tissue between the RE and VRE groups.","[{'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Ogawa', 'Affiliation': 'Graduate School of Education and Human Development, Nagoya University, Furo, Nagoya, Aichi, Japan.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Belavý', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universitätzu Berlin, Berlin Institute of Health, Institute of Radiology, Berlin, Germany.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Yoshiko', 'Affiliation': 'School of International Liberal Studies, Chukyo University, Toyota, Japan.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Armbrecht', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universitätzu Berlin, Berlin Institute of Health, Institute of Radiology, Berlin, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Miokovic', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universitätzu Berlin, Berlin Institute of Health, Institute of Radiology, Berlin, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universitätzu Berlin, Berlin Institute of Health, Institute of Radiology, Berlin, Germany.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Akima', 'Affiliation': 'Graduate School of Education and Human Development, Nagoya University, Furo, Nagoya, Aichi, Japan.'}]",Physiological reports,['10.14814/phy2.14560']
2191,32943115,Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark.,"OBJECTIVES


The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and mortality have been reported. We aim to test whether BCG vaccination may reduce susceptibility to and/or the severity of COVID-19 and other infectious diseases in health care workers (HCW) and thus prevent work absenteeism.The primary objective is to reduce absenteeism due to illness among HCW during the COVID-19 pandemic. The secondary objectives are to reduce the number of HCW that are infected with SARS-CoV-2, and to reduce the number of hospital admissions among HCW during the COVID-19 pandemic.
HYPOTHESIS


BCG vaccination of HCW will reduce absenteeism by 20% over a period of 6 months.
TRIAL DESIGN


Placebo-controlled, single-blinded, randomised controlled trial, recruiting study participants at several geographic locations. The BCG vaccine is used in this study on a different indication than the one it has been approved for by the Danish Medicines Agency, therefore this is classified as a phase III study.
PARTICIPANTS


The trial will recruit 1,500 HCW at Danish hospitals.To be eligible for participation, a subject must meet the following criteria: Adult (≥18 years); Hospital personnel working at a participating hospital for more than 22 hours per week.A potential subject who meets any of the following criteria will be excluded from participation in this study: Known allergy to components of the BCG vaccine or serious adverse events to prior BCG administration Known prior active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species Previous confirmed COVID-19 Fever (>38 C) within the past 24 hours Suspicion of active viral or bacterial infection Pregnancy Breastfeeding Vaccination with other live attenuated vaccine within the last 4 weeks Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1) b) subjects with solid organ transplantation c) subjects with bone marrow transplantation d) subjects under chemotherapy e) subjects with primary immunodeficiency f) subjects under treatment with any anti-cytokine therapy within the last year g) subjects under treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months h) Active solid or non-solid malignancy or lymphoma within the prior two years Direct involvement in the design or the execution of the BCG-DENMARK-COVID trial Intervention and comparator: Participants will be randomised to BCG vaccine (BCG-Denmark, AJ Vaccines, Copenhagen, Denmark) or placebo (saline). An adult dose of 0.1 ml of resuspended BCG vaccine (intervention) or 0.1 ml of sterile 0.9% NaCl solution (control) is administered intradermally in the upper deltoid area of the right arm. All participants will receive one injection at inclusion, and no further treatment of study participants will take place.
MAIN OUTCOMES


Main study endpoint: Days of unplanned absenteeism due to illness within 180 days of randomisation.Secondary study endpoints: The cumulative incidence of documented COVID-19 and the cumulative incidence of hospital admission for any reason within 180 days of randomisation.Randomisation: Randomisation will be done centrally using the REDCap tool with stratification by hospital, sex and age groups (+/- 45 years of age) in random blocks of 4 and 6. The allocation ratio is 1:1.Blinding (masking): Participants will be blinded to treatment. The participant will be asked to leave the room while the allocated treatment is prepared. Once ready for injection, vaccine and placebo will look similar, and the participant will not be able to tell the difference.The physicians administering the treatment are not blinded.Numbers to be randomised (sample size): Sample size: N=1,500. The 1,500 participants will be randomised 1:1 to BCG or placebo with 750 participants in each group.Trial Status: Current protocol version 5.1, from July 6, 2020.Recruitment of study participants started on May 18, 2020 and we anticipate having finished recruiting by the end of December 2020.
TRIAL REGISTRATION


The trial was registered with EudraCT on April 16, 2020, EudraCT number: 2020-001888-90, and with ClinicalTrials.gov on May 1, 2020, registration number NCT04373291.Full protocol: The full protocol is attached as an additional file, accessible from the Trialswebsite (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Once ready for injection, vaccine and placebo will look similar, and the participant will not be able to tell the difference.","['1,500 participants', 'participants started on May 18, 2020 and we anticipate having finished recruiting by the end of December 2020', 'on April 16, 2020, EudraCT number: 2020-001888-90, and with ClinicalTrials.gov on May 1, 2020', 'health care workers (HCW', '45 years of age) in random blocks of 4 and 6', 'criteria: Adult (≥18 years); Hospital personnel working at a participating hospital for more than 22 hours per week', 'subjects with known infection by the human immunodeficiency virus (HIV-1) b) subjects with solid organ transplantation c) subjects with bone marrow transplantation d) subjects under chemotherapy e) subjects with primary immunodeficiency f) subjects under treatment with any anti-cytokine therapy within the last year g) subjects under treatment with', '1,500 HCW at Danish hospitals', 'recruiting study participants at several geographic locations']","['Pregnancy Breastfeeding Vaccination with other live attenuated vaccine', 'oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months h) Active solid or non-solid malignancy or lymphoma within the prior two years Direct involvement in the design or the execution of the BCG-DENMARK-COVID trial Intervention and comparator', 'BCG vaccine', 'BCG vaccination', 'BCG or placebo', 'BCG vaccine (intervention) or 0.1 ml of sterile 0.9% NaCl solution (control', 'vaccine and placebo', 'Placebo', 'BCG vaccine (BCG-Denmark, AJ Vaccines, Copenhagen, Denmark) or placebo (saline', 'EudraCT']","['absenteeism', 'unplanned absenteeism due to illness', 'cumulative incidence of documented COVID-19 and the cumulative incidence of hospital admission']","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0031228', 'cui_str': 'Hospital Personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0556976', 'cui_str': 'hours/week'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0440790', 'cui_str': 'Solid organ'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0005961', 'cui_str': 'Transplantation of bone marrow'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0398686', 'cui_str': 'Primary immune deficiency disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199974', 'cui_str': 'Cytokine therapy'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0563322', 'cui_str': 'Intravenous steroid injection'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",1500.0,0.519545,"Once ready for injection, vaccine and placebo will look similar, and the participant will not be able to tell the difference.","[{'ForeName': 'Anne Marie Rosendahl', 'Initials': 'AMR', 'LastName': 'Madsen', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark. arosendahl@health.sdu.dk.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Schaltz-Buchholzer', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Center of Research & Disruption of Infectious Diseases (CREDID), Department of Infectious Diseases, Copenhagen University Hospital, Amager and Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bjerregaard-Andersen', 'Affiliation': 'Department of Medicine, Sydvestjysk Hospital, Esbjerg, Denmark.'}, {'ForeName': 'Lars Skov', 'Initials': 'LS', 'LastName': 'Dalgaard', 'Affiliation': 'Department of Medicine, Herning Hospital, Herning, Denmark.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dam', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Sisse Bolm', 'Initials': 'SB', 'LastName': 'Ditlev', 'Affiliation': 'The Copenhagen Center for Translational Research (CCTR), Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gulia', 'Initials': 'G', 'LastName': 'Faizi', 'Affiliation': 'Department of Medicine, Sydvestjysk Hospital, Esbjerg, Denmark.'}, {'ForeName': 'Isik Somuncu', 'Initials': 'IS', 'LastName': 'Johansen', 'Affiliation': 'Department of Infectious Diseases, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Poul-Erik', 'Initials': 'PE', 'LastName': 'Kofoed', 'Affiliation': 'Department of Pediatrics, Lillebaelt Hospital, Kolding, Denmark.'}, {'ForeName': 'Gitte Schultz', 'Initials': 'GS', 'LastName': 'Kristensen', 'Affiliation': 'Department of Medicine, Soenderjylland Hospital, Aabenraa, Denmark.'}, {'ForeName': 'Ellen Christine Leth', 'Initials': 'ECL', 'LastName': 'Loekkegaard', 'Affiliation': 'Department of Gynaecology and Obstetrics, Nordsjaellands Hospital, Hilleroed, Denmark.'}, {'ForeName': 'Christian Backer', 'Initials': 'CB', 'LastName': 'Mogensen', 'Affiliation': 'Department of Medicine, Soenderjylland Hospital, Aabenraa, Denmark.'}, {'ForeName': 'Libin', 'Initials': 'L', 'LastName': 'Mohamed', 'Affiliation': 'Department of Pediatrics, Lillebaelt Hospital, Kolding, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ostenfeld', 'Affiliation': 'Department of Gynaecology and Obstetrics, Nordsjaellands Hospital, Hilleroed, Denmark.'}, {'ForeName': 'Emilie Sundhaugen', 'Initials': 'ES', 'LastName': 'Oedegaard', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Marcus Kjaer', 'Initials': 'MK', 'LastName': 'Soerensen', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wejse', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital, Skejby, Denmark.'}, {'ForeName': 'Aksel Karl Georg', 'Initials': 'AKG', 'LastName': 'Jensen', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Tyra Grove', 'Initials': 'TG', 'LastName': 'Krause', 'Affiliation': 'Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Aaby', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Christine Stabell', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Bandim Health Project, OPEN, Department of Clinical Research, University of Southern Denmark/Odense University Hospital, Odense, Denmark.'}]",Trials,['10.1186/s13063-020-04714-3']
2192,32941336,Comparison of Pneumatonometry and Transpalpebral Tonometry Measurements of Intraocular Pressure during Scleral Lens Wear.,"SIGNIFICANCE


As scleral lens wear becomes more common, understanding the impact of these lenses upon ocular physiology is critically important. Studies on the effect of scleral lens wear upon intraocular pressure (IOP) have used different instruments and have reported conflicting results.
PURPOSE


The purpose of this study was to compare assessment of IOP during scleral lens wear using pneumatonometry and transpalpebral tonometry.
METHODS


Twenty healthy subjects wore a small-diameter (15.2 mm) and a large-diameter (18.0 mm) scleral lens on the right eye, each for 1 hour in randomized order. IOP was assessed with pneumatonometry and transpalpebral tonometry on both eyes before lens application, immediately after lens application, after 1 hour of lens wear, and immediately after lens removal. Paired t test compared mean IOP in the study eye to the control eye. Repeated-measures ANOVA was performed to take instrumentation, lens diameter, and their interaction into account in an analysis of the change in IOP in the study eye.
RESULTS


Mean peripheral IOP measured with pneumatonometry was not significantly different from baseline at any subsequent measurement. Measurements with transpalpebral tonometry, however, were significantly different during scleral lens wear immediately after application and after 1 hour of wear with both diameter lenses (P < .005), but were not significantly different after either sized lens was removed. Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001).
CONCLUSIONS


Assessment of IOP during scleral lens wear varies based upon the instrument that is used. Although further studies are clearly needed to further elucidate this issue, clinicians should continue to monitor optic nerve structure and function in scleral lens wearers, as they do in all patients.",2020,"Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001).
","['Intraocular Pressure during Scleral Lens Wear', 'Twenty healthy subjects wore a small-diameter (15.2 mm) and a large-diameter (18.0 mm) scleral lens on the right eye, each for 1 hour in randomized order']","['scleral lens wear upon intraocular pressure (IOP', 'Pneumatonometry and Transpalpebral Tonometry Measurements', 'pneumatonometry and transpalpebral tonometry']","['Mean peripheral IOP', 'IOP', 'IOP changes']","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0229089', 'cui_str': 'Right eye structure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",20.0,0.042258,"Repeated-measures ANOVA revealed that the instrument used to measure IOP was a significant factor in IOP changes found during lens wear (P ≤ .001).
","[{'ForeName': 'Jennifer Swingle', 'Initials': 'JS', 'LastName': 'Fogt', 'Affiliation': 'The Ohio State University, College of Optometry, Columbus, Ohio.'}, {'ForeName': 'Cherie B', 'Initials': 'CB', 'LastName': 'Nau', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Schornack', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Shorter', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Nau', 'Affiliation': 'Korb & Associates, Boston, Massachusetts.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Harthan', 'Affiliation': 'Illinois College of Optometry, Chicago, Illinois.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001574']
2193,32941649,Evaluating upfront high-dose consolidation after R-CHOP for follicular lymphoma by clinical and genetic risk models.,"High-dose therapy and autologous stem cell transplantation (HDT/ASCT) is an effective salvage treatment for eligible patients with follicular lymphoma (FL) and early progression of disease (POD). Since the introduction of rituximab, HDT/ASCT is no longer recommended in first remission. We here explored whether consolidative HDT/ASCT improved survival in defined subgroups of previously untreated patients. We report survival analyses of 431 patients who received frontline rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for advanced FL, and were randomized to receive consolidative HDT/ASCT. We performed targeted genotyping of 157 diagnostic biopsies, and calculated genotype-based risk scores. HDT/ASCT improved failure-free survival (FFS; hazard ratio [HR], 0.8, P = .07; as-treated: HR, 0.7, P = .04), but not overall survival (OS; HR, 1.3, P = .27; as-treated: HR, 1.4, P = .13). High-risk cohorts identified by FL International Prognostic Index (FLIPI), and the clinicogenetic risk models m7-FLIPI and POD within 24 months-prognostic index (POD24-PI) comprised 27%, 18%, and 22% of patients. HDT/ASCT did not significantly prolong FFS in high-risk patients as defined by FLIPI (HR, 0.9; P = .56), m7-FLIPI (HR, 0.9; P = .91), and POD24-PI (HR, 0.8; P = .60). Similarly, OS was not significantly improved. Finally, we used a machine-learning approach to predict benefit from HDT/ASCT by genotypes. Patients predicted to benefit from HDT/ASCT had longer FFS with HDT/ASCT (HR, 0.4; P = .03), but OS did not reach statistical significance. Thus, consolidative HDT/ASCT after frontline R-CHOP did not improve OS in unselected FL patients and subgroups selected by genotype-based risk models.",2020,"HDT/ASCT improved failure-free survival (FFS; hazard ratio [HR], 0.8, P = .07; as-treated: HR, 0.7, P = .04), but not overall survival (OS; HR, 1.3, P = .27; as-treated: HR, 1.4, P = .13).","['431 patients who received', 'eligible patients with follicular lymphoma (FL) and early progression of disease (POD']","['High-dose therapy and autologous stem cell transplantation (HDT/ASCT', 'HDT/ASCT', 'frontline rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'consolidative HDT/ASCT', 'rituximab, HDT/ASCT']","['failure-free survival', 'OS', 'FFS', 'overall survival', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0627849,"HDT/ASCT improved failure-free survival (FFS; hazard ratio [HR], 0.8, P = .07; as-treated: HR, 0.7, P = .04), but not overall survival (OS; HR, 1.3, P = .27; as-treated: HR, 1.4, P = .13).","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Alig', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Vindi', 'Initials': 'V', 'LastName': 'Jurinovic', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shahrokh Esfahani', 'Affiliation': 'Division of Oncology, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Haebe', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Passerini', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Hellmuth', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Gaitzsch', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Keay', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Natyra', 'Initials': 'N', 'LastName': 'Tahiri', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Zoellner', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenwald', 'Affiliation': 'Institute of Pathology, University of Würzburg, and Comprehensive Cancer Center Mainfranken, Würzburg, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Klapper', 'Affiliation': 'Hematopathology Section, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Stein', 'Affiliation': 'Pathodiagnostik Berlin, Berlin, Germany.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Feller', 'Affiliation': 'Hematopathology Lübeck, Lübeck, Germany.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Ott', 'Affiliation': 'Department of Clinical Pathology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Staiger', 'Affiliation': 'Department of Clinical Pathology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Horn', 'Affiliation': 'Department of Clinical Pathology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Martin L', 'Initials': 'ML', 'LastName': 'Hansmann', 'Affiliation': 'Senckenberg Institute of Pathology, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'Second Medical Department, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Unterhalt', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dreyling', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Ash A', 'Initials': 'AA', 'LastName': 'Alizadeh', 'Affiliation': 'Division of Oncology, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Weigert', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig-Maximilians University (LMU) Munich, Munich, Germany.'}]",Blood advances,['10.1182/bloodadvances.2020002546']
2194,32949103,Early access to antiretroviral therapy versus standard of care among HIV-positive participants in Eswatini in the public health sector: the MaxART stepped-wedge randomized controlled trial.,"INTRODUCTION


The WHO recommends antiretroviral treatment (ART) for all HIV-positive patients regardless of CD4 count or disease stage, referred to as ""Early Access to ART for All"" (EAAA). The health systems effects of EAAA implementation are unknown. This trial was implemented in a government-managed public health system with the aim to examine the ""real world"" impact of EAAA on care retention and viral suppression.
METHODS


In this stepped-wedge randomized controlled trial, 14 public sector health facilities in Eswatini were paired and randomly assigned to stepwise transition from standard of care (SoC) to EAAA. ART-naïve participants ≥18 years who were not pregnant or breastfeeding were eligible for enrolment. We used Cox proportional hazard models with censoring at clinic transition to estimate the effects of EAAA on retention in care and retention and viral suppression combined.
RESULTS


Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and EAAA respectively, 12-month HIV care retention rates were 80% (95% CI: 77 to 83) and 86% (95% CI: 83 to 88). The 12-month combined retention and viral suppression endpoint rates were 44% (95% CI: 40 to 48) under SoC compared to 80% (95% CI: 77 to 83) under EAAA. EAAA increased both retention (HR: 1·60, 95% CI: 1·15 to 2·21, p = 0.005) and retention and viral suppression combined (HR: 4.88, 95% CI: 2.96 to 8.05, p < 0.001). We also identified significant gaps in current health systems ability to provide viral load (VL) monitoring with 80% participants in SoC and 66% in EAAA having a missing VL at last contact.
CONCLUSIONS


The observed improvement in retention in care and on the combined retention and viral suppression provides an important co-benefit of EAAA to HIV-positive adults themselves, at least in the short term. Our results from this ""real world"" health systems trial strongly support EAAA for Eswatini and countries with similar HIV epidemics and health systems. VL monitoring needs to be scaled up for appropriate care management.",2020,The 12-month combined retention and viral suppression endpoint rates were 44% (95% CI: 40 to 48) under SoC compared to 80% (95% CI: 77 to 83) under EAAA.,"['14 public sector health facilities in Eswatini', '3405 participants were enrolled', 'ART-naïve participants ≥18\xa0years who were not pregnant or breastfeeding were eligible for enrolment', 'Between September 2014 and August 2017', 'HIV-positive participants in Eswatini in the public health sector']","['antiretroviral therapy versus standard of care', 'stepwise transition from standard of care (SoC) to EAAA']","['retention and viral suppression', 'retention (HR', '12-month HIV care retention rates', '12-month combined retention and viral suppression endpoint rates']","[{'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",3405.0,0.295478,The 12-month combined retention and viral suppression endpoint rates were 44% (95% CI: 40 to 48) under SoC compared to 80% (95% CI: 77 to 83) under EAAA.,"[{'ForeName': 'Shaukat', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Swaziland.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': 'Center on Methods for Implementation and Prevention Science and Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Walsh', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Boston, MA, USA.'}, {'ForeName': 'Sikhatele', 'Initials': 'S', 'LastName': 'Mazibuko', 'Affiliation': 'Eswatini National ART program (SNAP), Ministry of Health, Mbabane, Swaziland.'}, {'ForeName': 'Munyaradzi', 'Initials': 'M', 'LastName': 'Pasipamire', 'Affiliation': 'Eswatini National ART program (SNAP), Ministry of Health, Mbabane, Swaziland.'}, {'ForeName': 'Boyang', 'Initials': 'B', 'LastName': 'Chai', 'Affiliation': 'Department of Nutrition, Harvard T.H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Reis', 'Affiliation': 'Leiden University Medical Center, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Khudzie', 'Initials': 'K', 'LastName': 'Mlambo', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Swaziland.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Delva', 'Affiliation': 'The South African Department of Science and Technology - National Research Foundation (DST-NRF) Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Khumalo', 'Affiliation': 'Eswatini National Network of People Living with HIV (SWANNEPHA), Mbabane, Swaziland.'}, {'ForeName': 'Mandisa', 'Initials': 'M', 'LastName': 'Zwane', 'Affiliation': 'SAfAIDS, Manzini, Swaziland.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Fleming', 'Affiliation': 'aidsfonds, Amsterdam, the Netherlands.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mafara', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Swaziland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Swaziland.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lejeune', 'Affiliation': 'Clinton Health Access Initiative (CHAI), Mbabane, Swaziland.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Chao', 'Affiliation': 'Center on Methods for Implementation and Prevention Science and Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Public Health, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Velephi', 'Initials': 'V', 'LastName': 'Okello', 'Affiliation': 'Directorate Office, Ministry of Health, Mbabane, Swaziland.'}]",Journal of the International AIDS Society,['10.1002/jia2.25610']
2195,32949370,"Rapidity of CNS Effect on Photoparoxysmal Response for Brivaracetam vs. Levetiracetam: A Randomized, Double-blind, Crossover Trial in Photosensitive Epilepsy Patients.","INTRODUCTION


Both levetiracetam (LEV) and brivaracetam (BRV) eliminate the electroencephalogram photoparoxysmal response (PPR) in the human phase IIa photosensitivity model of epilepsy. The physiochemical properties of BRV differ from those of LEV, having higher potency and lipophilicity plus 10- to 15-fold greater affinity for synaptic vesicle glycoprotein 2A.
OBJECTIVE


We compared the rapidity of the effects of both drugs in the central nervous system (CNS) of patients with photosensitive epilepsy using time to PPR elimination post-intravenous infusion as a pharmacodynamic endpoint.
METHODS


Using a randomized, double-blind, two-period, balanced, crossover design, we tested patients with photosensitive epilepsy with equipotent milligram doses of intravenous LEV 1500 mg versus BRV 100 mg post-15-min intravenous infusion (part 1) and post-5-min intravenous infusion (part 2, same doses). Eight patients per part were deemed sufficient with 80% power to determine a 70% reduction for intravenous BRV:LEV intrapatient time ratio to PPR elimination, with a 0.05 two-sided significance level. Plasma antiseizure medicine concentrations were measured using liquid chromatography/mass spectrometry.
RESULTS


Nine patients [six women; mean age 27.8 years (range 18-42)] completed the study; seven of these participated in both parts 1 and 2. In 31 of 32 instances, patients experienced PPR elimination. In mixed-effects model time analysis, BRV eliminated PPRs more quickly than did LEV (median 2 vs. 7.5 min, respectively). However, no statistically significant difference in BRV:LEV time ratio to PPR elimination was observed for two of our multiple primary outcomes: for the 15-min infusion alone (p = 0.22) or the 5-min infusion alone (p = 0.11). However, BRV was faster when we excluded an outlier patient in part 1 (p = 0.0016). For our remaining primary outcome, parts 1 and 2 data combined, the median intrapatient BRV:LEV time ratio was 0.39 [95% confidence interval (CI) 0.16-0.91], i.e., PPR elimination was 61% faster with BRV, p = 0.039. PPR was completely eliminated in ≤ 2 min in 11 patients with BRV and in four patients with LEV. No period or carryover effects were seen. No serious or severe adverse effects occurred. At PPR elimination (n = 16), median plasma [BRV] was 250 ng/mL (range 30-4100) and median plasma [LEV] was 28.35 μg/mL (range 1-86.7).
CONCLUSION


Outcome studies directly comparing LEV and BRV are needed to define the clinical utility of the response with BRV, which was several minutes faster than that with LEV.
CLINICAL TRIALS


ClinTrials.gov Identifier = NCT03580707; registered 07-09-18.",2020,"However, BRV was faster when we excluded an outlier patient in part 1 (p = 0.0016).","['Photosensitive Epilepsy Patients', 'Nine patients [six women; mean age 27.8\xa0years (range 18-42)] completed the study; seven of these participated in both parts 1 and 2', 'patients with photosensitive epilepsy with equipotent milligram doses of', 'patients with photosensitive epilepsy']","['levetiracetam (LEV) and brivaracetam (BRV', 'Levetiracetam', 'intravenous LEV 1500\xa0mg versus BRV 100\xa0mg post-15-min intravenous infusion (part 1) and post-5-min intravenous infusion']","['PPR elimination', 'median plasma [BRV', 'BRV:LEV time ratio to PPR elimination', 'median plasma [LEV', 'No serious or severe adverse effects', 'Plasma antiseizure medicine concentrations', 'median intrapatient BRV:LEV time ratio', 'PPR', 'BRV', 'intravenous BRV:LEV intrapatient time ratio to PPR elimination']","[{'cui': 'C0393720', 'cui_str': 'Photogenic epilepsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439210', 'cui_str': 'mg'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3893014', 'cui_str': 'Levetiracetam 1500 MG [Elepsia]'}, {'cui': 'C4083398', 'cui_str': 'Brivaracetam 100 MG'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C1264675', 'cui_str': 'Time ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]",11.0,0.244532,"However, BRV was faster when we excluded an outlier patient in part 1 (p = 0.0016).","[{'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Reed', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, West Virginia University, 1124 Health Science Center North, Morgantown, WV, 26506-9520, USA. ronald.reed@hsc.wvu.edu.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Rosenfeld', 'Affiliation': 'Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, MO, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Lippmann', 'Affiliation': 'Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, MO, USA.'}, {'ForeName': 'Rene M J C', 'Initials': 'RMJC', 'LastName': 'Eijkemans', 'Affiliation': 'Head of Biostatistics and Research Support, Julius Center for Health Sciences and Primary Care, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Dorothee G A', 'Initials': 'DGA', 'LastName': 'Kasteleijn-Nolst Trenité', 'Affiliation': 'Department of Neurosurgery and Epilepsy, University Medical Center, Utrecht University, Utrecht, The Netherlands.'}]",CNS drugs,['10.1007/s40263-020-00761-1']
2196,32948554,Protocol and statistical analysis plan for the PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) randomised clinical trial.,"INTRODUCTION


Cardiovascular collapse is a common complication during tracheal intubation of critically ill adults. Whether administration of an intravenous fluid bolus prevents cardiovascular collapse during tracheal intubation remains uncertain. A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
METHODS AND ANALYSIS


The PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) trial is a prospective, multi-centre, non-blinded randomised trial being conducted in 13 academic intensive care units in the USA. The trial will randomise 1065 critically ill adults undergoing tracheal intubation with planned use of positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus. The primary outcome is cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation. The primary analysis will be an unadjusted, intention-to-treat comparison of the primary outcome between patients randomised to fluid bolus administration and patients randomised to no fluid bolus administration using a χ 2  test. The sole secondary outcome is 28-day in-hospital mortality. Enrolment began on 1 February 2019 and is expected to conclude in June 2020.
ETHICS AND DISSEMINATION


The trial was approved by either the central institutional review board at Vanderbilt University Medical Center or the local institutional review board at each trial site. Results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.
TRIAL REGISTRATION NUMBER


NCT03787732.",2020,"A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
","['13 academic intensive care units in the USA', 'patients receiving positive pressure ventilation during tracheal intubation', '1065 critically ill adults undergoing tracheal intubation with planned use of', 'critically ill adults']","['intravenous fluid bolus', 'fluid REsuscitation', 'positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus', 'fluid REsuscitation during Induction and Intubation']","['cardiovascular collapse', '28-day in-hospital mortality', 'cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",1065.0,0.64588,"A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
","[{'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Russell', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA dwrussell@uabmc.edu.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gibbs', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Dargin', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Vonderhaar', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Ochsner Health System, New Orleans, Louisiana, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Joffe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Shekhar', 'Initials': 'S', 'LastName': 'Ghamande', 'Affiliation': 'Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Simanta', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Janna S', 'Initials': 'JS', 'LastName': 'Landsperger', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Robison', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Bentov', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wozniak', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stempek', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts, USA.'}, {'ForeName': 'Heath D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, Baylor Scott & White Medical Center, Temple, Texas, USA.'}, {'ForeName': 'Olivia F', 'Initials': 'OF', 'LastName': 'Krol', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Prekker', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Brewer', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Christopher John', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Janz', 'Affiliation': 'Department of Medicine, Section of Pulmonary/Critical Care Medicine and Allergy/Immunology, Louisiana State University School of Medicine in New Orleans, New Orleans, Louisiana, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036671']
2197,32948579,"Correction: Efficacy of  Bifidobacterium animalis  subsp. lactis (BB-12), B.  infantis  and  Lactobacillus acidophilus  (La-5) probiotics to prevent gut dysbiosis in preterm infants of 28+0-32+6 weeks of gestation: a randomised, placebo-controlled, double-blind, multicentre trial: the PRIMAL Clinical Study Protocol.",,2020,,['preterm infants of 28+0-32+6 weeks of gestation'],"['placebo', 'Bifidobacterium animalis  subsp']",[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",[],,0.392847,,[],BMJ open,['10.1136/bmjopen-2019-032617corr1']
2198,32948800,Effect of acute physical exercise on motor sequence memory.,"Acute physical exercise improves memory functions by increasing neural plasticity in the hippocampus. In animals, a single session of physical exercise has been shown to boost anandamide (AEA), an endocannabinoid known to promote hippocampal plasticity. Hippocampal neuronal networks encode episodic memory representations, including the temporal organization of elements, and can thus benefit motor sequence learning. While previous work established that acute physical exercise has positive effects on declarative memory linked to hippocampal plasticity mechanisms, its influence on memory for motor sequences, and especially on neural mechanisms underlying possible effects, has been less investigated. Here we studied the impact of acute physical exercise on motor sequence learning, and its underlying neurophysiological mechanisms in humans, using a cross-over randomized within-subjects design. We measured behavior, fMRI activity, and circulating AEA levels in fifteen healthy participants while they performed a serial reaction time task before and after a short period of exercise (moderate or high intensity) or rest. We show that exercise enhanced motor sequence memory, significantly for high intensity exercise and tending towards significance for moderate intensity exercise. This enhancement correlated with AEA increase, and dovetailed with local increases in caudate nucleus and hippocampus activity. These findings demonstrate that acute physical exercise promotes sequence learning, thus attesting the overarching benefit of exercise to hippocampus-related memory functions.",2020,"We show that exercise enhanced motor sequence memory, significantly for high intensity exercise and tending towards significance for moderate intensity exercise.",['fifteen healthy participants while they performed a serial reaction time task before and after a short period of exercise (moderate or high intensity) or rest'],"['acute physical exercise', 'physical exercise', 'Acute physical exercise']","['motor sequence memory', 'behavior, fMRI activity, and circulating AEA levels', 'caudate nucleus and hippocampus activity', 'memory functions']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0425946', 'cui_str': 'Short menstrual periods'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007461', 'cui_str': 'Caudate nucleus structure'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",15.0,0.0360965,"We show that exercise enhanced motor sequence memory, significantly for high intensity exercise and tending towards significance for moderate intensity exercise.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Marin Bosch', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland. blanca.marinbosch@unige.ch.'}, {'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Bringard', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Logrieco', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Lauer', 'Affiliation': 'Unit of Toxicology, CURML, Lausanne University Hospital and Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Imobersteg', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Aurélien', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Unit of Toxicology, CURML, Lausanne University Hospital and Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferretti', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Igloi', 'Affiliation': 'Department of Neuroscience, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-72108-1']
2199,32947424,"Does Pregnenolone Adjunct to Risperidone Ameliorate Irritable Behavior in Adolescents With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial?","OBJECTIVES


Pregnenolone is a neurosteroid with modulatory effects on γ-aminobutyric acid neurotransmission. Here, we aimed to evaluate the effectiveness and safety of pregnenolone add-on to risperidone in adolescents with autism spectrum disorders (ASD).
METHODS


Sixty-four ASD patients were randomly allocated to receive either pregnenolone (n = 32) or matching placebo (n = 32) in addition to risperidone. The Aberrant Behavior Checklist-Community Edition scale was used to evaluate the behavioral status of patients at baseline, week 5, and the trial end point. The change in score of irritability subscale was the primary outcome. Frequency of adverse effects due to trial medications was compared between the treatment groups.
RESULTS


Fifty-nine patients completed the trial (30 in pregnenolone and 29 in the placebo arm). Baseline characteristics of both treatment groups were similar (P > 0.05). Repeated measures analysis was suggestive of greater exhibited improvement for the pregnenolone group on irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition over the trial period (F = 3.84, df = 1.96, P = 0.025; F = 4.29, df = 1.39, P = 0.029; F = 6.55, df = 1.67, P = 0.004, respectively). Nonetheless, the alterations in lethargy and inappropriate speech domains scores were similar for both arms (F = 0.93, df = 1.49, P = 0.375; F = 1.10, df = 1.60, P = 0.325, respectively). There was no significant difference in frequency as well as severity of adverse effects between the 2 groups.
CONCLUSIONS


Pregnenolone adjunct to risperidone could attenuate core features associated with ASD.",2020,"Repeated measures analysis was suggestive of greater exhibited improvement for the pregnenolone group on irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition over the trial period (F = 3.84, df = 1.96, P = 0.025; F = 4.29, df = 1.39, P = 0.029; F = 6.55, df = 1.67, P = 0.004, respectively).","['Adolescents With Autism', 'adolescents with autism spectrum disorders (ASD', 'Fifty-nine patients completed the trial (30 in pregnenolone and 29 in the placebo arm', 'Sixty-four ASD patients', 'Spectrum Disorder']","['Pregnenolone', 'Risperidone', 'risperidone', 'matching placebo', 'pregnenolone', 'Placebo']","['Aberrant Behavior Checklist-Community Edition scale', 'effectiveness and safety', 'irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition', 'lethargy and inappropriate speech domains scores', 'score of irritability subscale', 'severity of adverse effects']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033016', 'cui_str': 'Pregnenolone measurement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0033016', 'cui_str': 'Pregnenolone measurement'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C1168248', 'cui_str': 'Inappropriate speech'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",64.0,0.524653,"Repeated measures analysis was suggestive of greater exhibited improvement for the pregnenolone group on irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition over the trial period (F = 3.84, df = 1.96, P = 0.025; F = 4.29, df = 1.39, P = 0.029; F = 6.55, df = 1.67, P = 0.004, respectively).","[{'ForeName': 'Arghavan', 'Initials': 'A', 'LastName': 'Ayatollahi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sayna', 'Initials': 'S', 'LastName': 'Bagheri', 'Affiliation': ''}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ashraf-Ganjouei', 'Affiliation': ''}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Moradi', 'Affiliation': ''}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Mohammadi', 'Affiliation': ''}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': ''}]",Clinical neuropharmacology,['10.1097/WNF.0000000000000405']
2200,32947423,Nalbuphine Exhibited a Better Adjuvant Than Dexmedetomidine in Supraclavicular Brachial Plexus Block in Youths.,"OBJECTIVE


Nalbuphine and dexmedetomidine are both used as anesthesia adjuvants for brachial plexus block, but their efficacy and safety in younger patients are not clear. In this study, we aimed to compare the efficacy and side effects of these 2 drugs in young patients undergoing brachial plexus block.
METHODS


We recruited 48 young patients aged 18 to 30 years requiring supraclavicular brachial plexus block. Subjects were randomly divided into 2 groups. Patients in group levobupivacaine+nalbuphine received 28 mL of 0.5% levobupivacaine and 10 mg of nalbuphine diluted in 2 mL 0.9% saline. Patients in group levobupivacaine+dexmedetomidine (LD) received 28 mL of 0.5% levobupivacaine and 0.75 μg/kg dexmedetomidine diluted in 2 mL 0.9% saline. Demographic information, types of fracture, onset time of motor and sensory blocks, duration of block, side effects, and analgesic use were recorded.
RESULTS


We found that the 2 groups did not differ significantly in the demographic profile and fracture type. Compared with group LD, group LD had significantly shorter sensory and motor block onset time, longer block duration, less analgesic need, and less side effects.
CONCLUSION


In summary, our study suggests that nalbuphine is a better anesthesia adjuvant for supraclavicular brachial plexus block in young patients.",2020,"Compared with group LD, group LD had significantly shorter sensory and motor block onset time, longer block duration, less analgesic need, and less side effects.
","['younger patients', '48 young patients aged 18 to 30 years requiring supraclavicular brachial plexus block', 'Youths', 'young patients', 'young patients undergoing brachial plexus block']","['levobupivacaine+dexmedetomidine (LD) received 28 mL of 0.5% levobupivacaine', 'dexmedetomidine diluted in 2 mL 0.9% saline', 'nalbuphine', 'Nalbuphine and dexmedetomidine', 'Dexmedetomidine', 'levobupivacaine', 'nalbuphine diluted in 2 mL 0.9% saline', 'Nalbuphine']","['efficacy and side effects', 'demographic profile and fracture type', 'shorter sensory and motor block onset time, longer block duration, less analgesic need, and less side effects', 'Demographic information, types of fracture, onset time of motor and sensory blocks, duration of block, side effects, and analgesic use']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}]","[{'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",48.0,0.107087,"Compared with group LD, group LD had significantly shorter sensory and motor block onset time, longer block duration, less analgesic need, and less side effects.
","[{'ForeName': 'Changcheng', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital.'}, {'ForeName': 'Wenji', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Quanzhou Hospital of Traditional Chinese Medicine, Quanzhou.'}, {'ForeName': 'Wenqin', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital.'}, {'ForeName': 'Zhenming', 'Initials': 'Z', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University of China, Quanzhou, Fujian, China.'}, {'ForeName': 'Naizhen', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Quanzhou First Hospital.'}]",Clinical neuropharmacology,['10.1097/WNF.0000000000000410']
2201,32948120,"Sing4Health: protocol of a randomized controlled trial of the effects of a singing group intervention on the well-being, cognitive function and health of older adults.","BACKGROUND


Singing is a multimodal activity that requires physical, cognitive and psychosocial performance, with benefits to various domains of well-being and health in older adults. In recent years, research has increasingly studied group singing as an important cost-effective intervention to promote active and healthy aging. However, the specific factors responsible for these benefits need further experimental support, as most studies do not allow for causal inferences. This study responds to the need for further randomized controlled trials (RCT), with follow-up measurement, on the benefits of group singing in older adults from a low socioeconomic background. Also, while most studies often focus on specific outcome measure dimensions, in this study, the conjoint effect of several physical, psychosocial, psychoemotional and cognitive dimensions are analyzed, testing mediation effects of psychosocial and psychoemotional variables on the well-being and health of the participants.
METHODS


We implement and measure the effects of a singing group program for older adults, with an RCT crossover design study, in a natural context, before and after the intervention and in a follow-up, 6 months after the intervention.
PARTICIPANTS


140 retired older adults (> 60 years) users of a social support institution, will be invited to participate in a singing group program and randomly allocated to an experimental (n = 70) and a control (n = 70) group, which will enroll in the regular activities proposed by the institution. The intervention consists of 34 bi-weekly group singing sessions, of 2 h each, for 4 months. Measures on social and emotional well-being, cognitive function, and health indicators (e.g., blood pressure, glycemia, cholesterol, c-reactive protein, sedimentation rate, respiratory function, body balance, sleep quality, medication intake, and health services attendance) will be collected. Interviews will be conducted on the motivation and perceived benefits of participation.
DISCUSSION


Significant improvements are expected in the outcome measures in the experimental group after the intervention, validating singing groups as a cost-effective intervention for healthy aging. Psychosocial and psychoemotional variables are expected to be mediators of the effects of the program in the cognitive function, well-being and health of the participants.
TRIAL REGISTRATION


NCT03985917 . Registered 14th June 2019 (retrospectively registered).",2020,"DISCUSSION


Significant improvements are expected in the outcome measures in the experimental group after the intervention, validating singing groups as a cost-effective intervention for healthy aging.","['older adults', '140 retired older adults (>\u200960\u2009years) users of a social support institution, will be invited to participate in a singing group program', 'older adults from a low socioeconomic background', 'healthy aging']","['singing group intervention', 'singing group program']","['social and emotional well-being, cognitive function, and health indicators (e.g., blood pressure, glycemia, cholesterol, c-reactive protein, sedimentation rate, respiratory function, body balance, sleep quality, medication intake, and health services attendance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C2963171', 'cui_str': 'Healthy Ageing'}]","[{'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0325504,"DISCUSSION


Significant improvements are expected in the outcome measures in the experimental group after the intervention, validating singing groups as a cost-effective intervention for healthy aging.","[{'ForeName': 'Iolanda Costa', 'Initials': 'IC', 'LastName': 'Galinha', 'Affiliation': 'Centro de Investigação em Psicologia (CIP), da Universidade Autónoma de Lisboa / Universidade do Algarve, CIS-ISTE-IUL; APPSYCI, Rua de Santa Marta, 47, 3° (Room, 304), 1169-023, Lisbon, Portugal. igalinha@autonoma.pt.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Farinha', 'Affiliation': 'Centro de Investigação em Psicologia (CIP), da Universidade Autónoma de Lisboa / Universidade do Algarve from Rua de Santa Marta, 47, 3° (Room, 304), 1169-023, Lisbon, Portugal.'}, {'ForeName': 'Maria Luísa', 'Initials': 'ML', 'LastName': 'Lima', 'Affiliation': 'ISCTE CIS IUL, Av. das Forças Armadas, ISCTE-IUL building, 2w17 Room, 1649-026, Lisbon, Portugal.'}, {'ForeName': 'António Labisa', 'Initials': 'AL', 'LastName': 'Palmeira', 'Affiliation': 'Universidade de Lisboa & Universidade Lusófona de Humanidades e Tecnologias, Campo Grande, 376, 1749-024, Lisbon, Portugal.'}]",BMC geriatrics,['10.1186/s12877-020-01686-6']
2202,32948138,Lower versus higher diagnostic criteria for the detection of gestational diabetes for reducing maternal and perinatal morbidity: study protocol for the GEMS randomised trial.,"BACKGROUND


Gestational diabetes mellitus (GDM) has lifelong implications for the woman and her infant. Treatment reduces adverse maternal and perinatal outcomes although uncertainty remains about the optimal diagnostic criteria. The GEMS Trial aims to assess whether detection and treatment of women with GDM using the lower International Association of Diabetes in Pregnancy Study Groups diagnostic criteria compared with the higher criteria recommended in New Zealand reduces infant morbidity without increasing maternal morbidity.
METHODS


GEMS is a multicentre, randomised trial. Women with a singleton pregnancy at 24 to 34 weeks' gestation are eligible who give written informed consent. Women are randomly allocated to the Lower Criteria Group or the Higher Criteria Group. Women with a normal OGTT by their allocated criteria receive routine care (Higher criteria: fasting plasma glucose < 5.5 mmol/L, AND 2 hour < 9.0 mmol/L; Lower criteria: fasting plasma glucose < 5.1 mmol/L, AND 1 hour < 10.0 mmol/L, AND 2 hour < 8.5 mmol/l). Women with GDM on OGTT by their allocated criteria receive standard care for GDM (Higher criteria: fasting plasma glucose ≥ 5.5 mmol/L, OR 2 hour ≥ 9.0 mmol/L; Lower criteria: fasting plasma glucose ≥ 5.1 mmol/L, OR 1 hour ≥ 10.0 mmol/L, OR 2 hour ≥ 8.5 mmol/L). The primary outcome is large for gestational age (birth weight > 90th centile). Secondary outcomes for the infant include a composite of serious outcomes, gestational age, anthropometry, Apgar score < 4 at 5 minutes, lung disease, use of respiratory support, hypoglycaemia, hyperbilirubinaemia, infection, and encephalopathy; and for the woman, a composite of serious outcomes, preeclampsia, induction of labour, mode of birth, weight gain, postpartum haemorrhage and infectious morbidity. A study with 4,158 women will detect an absolute difference of 2.9% in the proportion of large for gestational age infants from 10.0% using the lower criteria to 12.9% with the higher criteria.
DISCUSSION


The GEMS Trial will provide high-level evidence relevant for clinical practice. If use of the lower diagnostic criteria results in significantly fewer large for gestational age infants and/or improves maternal and perinatal outcomes these criteria should be recommended for diagnosis of gestational diabetes.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry registration number ACTRN12615000290594 . Date registered: 27th March 2015.",2020,"If use of the lower diagnostic criteria results in significantly fewer large for gestational age infants and/or improves maternal and perinatal outcomes these criteria should be recommended for diagnosis of gestational diabetes.
","['Women with a normal OGTT by their allocated criteria receive', ""Women with a singleton pregnancy at 24 to 34 weeks' gestation are eligible who give written informed consent"", '4,158 women', 'Women with GDM on OGTT by their allocated criteria receive', 'women with GDM', 'Gestational diabetes mellitus (GDM']","['standard care for GDM (Higher criteria: fasting plasma glucose\u2009≥\u20095.5\xa0mmol/L, OR 2 hour', 'routine care (Higher criteria: fasting plasma glucose\u2009<\u20095.5\xa0mmol/L, AND 2 hour\u2009<\u20099.0\xa0mmol/L; Lower criteria: fasting plasma glucose\u2009<\u20095.1\xa0mmol/L, AND 1 hour\u2009<\u200910.0\xa0mmol/L, AND 2 hour\u2009<\u20098.5\xa0mmol/l']","['adverse maternal and perinatal outcomes', 'infant include a composite of serious outcomes, gestational age, anthropometry, Apgar score\u2009<\u20094\xa0at 5 minutes, lung disease, use of respiratory support, hypoglycaemia, hyperbilirubinaemia, infection, and encephalopathy; and for the woman, a composite of serious outcomes, preeclampsia, induction of labour, mode of birth, weight gain, postpartum haemorrhage and infectious morbidity', 'large for gestational age (birth weight\u2009>\u200990th centile']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0085584', 'cui_str': 'Encephalopathy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]",4158.0,0.156033,"If use of the lower diagnostic criteria results in significantly fewer large for gestational age infants and/or improves maternal and perinatal outcomes these criteria should be recommended for diagnosis of gestational diabetes.
","[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, The University of Auckland, Building 503, Level 2, 85 Park Road, Auckland Private Bag 92019, 1142, Auckland, New Zealand. c.crowther@auckland.ac.nz.'}, {'ForeName': 'Lesley M E', 'Initials': 'LME', 'LastName': 'McCowan', 'Affiliation': 'Department Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Rowan', 'Affiliation': ""Department of Obstetrics, National Women's Health, Auckland City Hospital, Auckland, New Zealand.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Edlin', 'Affiliation': 'School of Population Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Christopher J D', 'Initials': 'CJD', 'LastName': 'McKinlay', 'Affiliation': 'Liggins Institute, The University of Auckland, Building 503, Level 2, 85 Park Road, Auckland Private Bag 92019, 1142, Auckland, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03252-9']
2203,32948178,Learning outcomes of a flipped classroom teaching approach in an adult-health nursing course: a quasi-experimental study.,"BACKGROUND


New teaching strategies must be developed not only to enhance nurse's competence but also to allow nurses to respond to the complex health care needs of today's society. The purpose of this study was to explore the learning outcomes of a flipped classroom teaching approach in an adult-health nursing course for students in a two-year Bachelor of Science in Nursing program.
METHODS


The study had a quasi-experimental design. An 18-week flipped classroom teaching approach was applied in an adult-health nursing course. In total, 485 nursing students enrolled in the study, with 287 in the experimental group and 198 in the control group. The Self-Evaluated Core Competencies Scale, Metacognitive Inventory for Nursing Students, Self-Directed Learning Readiness Scale, and self-designed learning satisfaction questionnaire were used to evaluate the students' learning outcomes.
RESULTS


The experimental group showed a statistically significant increase in the overall scores for self-evaluated core competencies, the ""self-modification"" subscale of the Metacognitive Inventory for Nursing Students, and in overall self-directed learning readiness; further, they also showed high levels of course satisfaction.
CONCLUSIONS


A flipped classroom teaching approach had a positive impact on student's learning motivation and contributed to better learning outcomes in an adult-health nursing course. The flipped classroom combined with hybrid teaching methods is a suitable and effective learning strategy for a registered nurse (RN) to Bachelor of Science in Nursing (BSN) program to tackle today's complex revolution in nursing curricula, and may enhance nursing students' abilities to address numerous challenges.",2020,"The experimental group showed a statistically significant increase in the overall scores for self-evaluated core competencies, the ""self-modification"" subscale of the Metacognitive Inventory for Nursing Students, and in overall self-directed learning readiness; further, they also showed high levels of course satisfaction.
","['adult-health nursing course for students in a two-year Bachelor of Science in Nursing program', '485 nursing students enrolled in the study, with 287 in the experimental group and 198 in the control group', 'adult-health nursing course']",['flipped classroom teaching approach'],"['Self-Evaluated Core Competencies Scale, Metacognitive Inventory for Nursing Students, Self-Directed Learning Readiness Scale, and self-designed learning satisfaction questionnaire', 'overall scores for self-evaluated core competencies, the ""self-modification"" subscale of the Metacognitive Inventory for Nursing Students, and in overall self-directed learning readiness', 'learning outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",485.0,0.0146476,"The experimental group showed a statistically significant increase in the overall scores for self-evaluated core competencies, the ""self-modification"" subscale of the Metacognitive Inventory for Nursing Students, and in overall self-directed learning readiness; further, they also showed high levels of course satisfaction.
","[{'ForeName': 'Jun-Yu', 'Initials': 'JY', 'LastName': 'Fan', 'Affiliation': 'Department of Nursing & Graduate Institute of Nursing, Chang Gung University of Science and Technology, Division of Nursing, Chang Gung Memorial Hospital, Linkou Branch, 261, Wen-Hua 1st Road, Kwei-Shan, Tao-Yuan, 33303, Taiwan (R.O.C.). jyfan@gw.cgust.edu.tw.'}, {'ForeName': 'Ying-Jung', 'Initials': 'YJ', 'LastName': 'Tseng', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, 261, Wen-Hua 1st Road, Kwei-Shan, Tao-Yuan, 33303, Taiwan (R.O.C.).'}, {'ForeName': 'Li-Fen', 'Initials': 'LF', 'LastName': 'Chao', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, 261, Wen-Hua 1st Road, Kwei-Shan, Tao-Yuan, 33303, Taiwan (R.O.C.).'}, {'ForeName': 'Shiah-Lian', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, National Taichung University of Science and Technology, No.129, Sec. 3, Sanmin Rd., North Dist., Taichung City, 40401, Taiwan (R.O.C.).'}, {'ForeName': 'Sui-Whi', 'Initials': 'SW', 'LastName': 'Jane', 'Affiliation': 'Department of Nursing & Graduate Institute of Nursing, Chang Gung University of Science and Technology, 261, Wen-Hua 1st Road, Kwei-Shan, Tao-Yuan, 33303, Taiwan (R.O.C.).'}]",BMC medical education,['10.1186/s12909-020-02240-z']
2204,32951538,"Rationale, Design, and Implementation of Intensive Risk Factor Treatment in the CREST2 Trial.","BACKGROUND AND PURPOSE


The CREST2 trial (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis) is comparing intensive medical management (IMM) alone to IMM plus revascularization with carotid endarterectomy or transfemoral carotid artery stenting for preventing stroke or death within 44 days after randomization or ipsilateral ischemic stroke thereafter. There are extensive clinical trial data on outcomes after revascularization of asymptomatic carotid stenosis, but not for IMM. As such, the experimental treatment in CREST2 is IMM, which is described in this article.
METHODS


IMM consists of aspirin 325 mg/day and intensive risk factor management, primarily targeting systolic blood pressure <130 mm Hg (initially systolic blood pressure <140 mm Hg) and LDL (low-density lipoprotein) cholesterol <70 mg/dL. Secondary risk factor targets focus on tobacco smoking, non-HDL (high-density lipoprotein), HbA1c (hemoglobin A1c), physical activity, and weight. Risk factor management is performed by site personnel and a lifestyle coaching program delivered by telephone. We report interim risk factor data on 1618 patients at baseline and last follow-up through 24 months.
RESULTS


The mean baseline LDL of 80.5 mg/dL improved to 66.7 mg/dL. The mean baseline systolic blood pressure of 139.7 mm Hg improved to 130.3 mm Hg. The proportion of patients in-target improved from 43% to 61% for systolic blood pressure <130 mm Hg and from 45% to 67% for LDL<70 mg/dL (both changes  P <0.001).
CONCLUSIONS


The rigorous multimodal approach to intensive stroke risk factor management in CREST2 has resulted in significant improvements in risk factor control that will enable a comparison of cutting-edge medical care to revascularization in patients with asymptomatic carotid stenosis.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02089217.",2020,"The proportion of patients in-target improved from 43% to 61% for systolic blood pressure <130 mm Hg and from 45% to 67% for LDL<70 mg/dL (both changes  P <0.001).
","['1618 patients at baseline and last follow-up through 24 months', 'patients with asymptomatic carotid stenosis', 'Asymptomatic Carotid Stenosis']","['aspirin 325 mg/day and intensive risk factor management, primarily targeting systolic blood pressure <130 mm Hg (initially systolic blood pressure <140 mm Hg) and LDL (low-density lipoprotein) cholesterol <70 mg/dL. Secondary risk factor targets', 'IMM plus revascularization with carotid endarterectomy or transfemoral carotid artery stenting']","['tobacco smoking, non-HDL (high-density lipoprotein), HbA1c (hemoglobin A1c), physical activity, and weight', 'mean baseline LDL', 'systolic blood pressure', 'mean baseline systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}]","[{'cui': 'C0992015', 'cui_str': 'Aspirin 325 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1277632', 'cui_str': 'Target systolic blood pressure'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}]",1618.0,0.152957,"The proportion of patients in-target improved from 43% to 61% for systolic blood pressure <130 mm Hg and from 45% to 67% for LDL<70 mg/dL (both changes  P <0.001).
","[{'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Neurology, Medical University of South Carolina, Charleston, SC. (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.).'}, {'ForeName': 'Jenifer H', 'Initials': 'JH', 'LastName': 'Voeks', 'Affiliation': 'Neurology, Medical University of South Carolina, Charleston, SC. (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.).'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Neurology, Medical University of South Carolina, Charleston, SC. (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.).'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Roldan', 'Affiliation': 'Neurology, Medical University of South Carolina, Charleston, SC. (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.).'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'LeMatty', 'Affiliation': 'Neurology, Medical University of South Carolina, Charleston, SC. (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.).'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Haley', 'Affiliation': 'Neurology, Medical University of South Carolina, Charleston, SC. (T.N.T., J.H.V., M.I.C., A.R., T.L., W.H.).'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lopes-Virella', 'Affiliation': 'Medicine, Medical University of South Carolina, Charleston, SC. (M.L.-V.).'}, {'ForeName': 'Seemant', 'Initials': 'S', 'LastName': 'Chaturvedi', 'Affiliation': 'Medical University of South Carolina, Charleston, SC. Neurology (S.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Cardiology, Baptist Health, Lexington, KY (M.J.).'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Heck', 'Affiliation': 'Radiology, Novant Health, Winston-Salem, NC (D.H.).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Howard', 'Affiliation': 'Biostatistics, University of Alabama at Birmingham (G.H.).'}, {'ForeName': 'Brajesh K', 'Initials': 'BK', 'LastName': 'Lal', 'Affiliation': 'Vascular Surgery, University of Maryland, Baltimore. (B.K.L.).'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Meschia', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.).'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Brott', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL (J.F.M., T.G.B.).'}]",Stroke,['10.1161/STROKEAHA.120.030730']
2205,32951632,CPAP increases physical activity in obstructive sleep apnea with cardiovascular disease.,"STUDY OBJECTIVES


Uncertainty exists over whether continuous positive airway pressure (CPAP) treatment improves moderate to vigorous physical activity levels in those with obstructive sleep apnea (OSA). We aimed to determine effects of CPAP on moderate to vigorous physical activity among participants with co-occurring cardiovascular disease and OSA.
METHODS


The Sleep Apnea cardioVascular Endpoints (SAVE) trial recruited participants with confirmed CV disease history and OSA, 45 - 75 years old. 2687 participants (1346 randomized to CPAP plus usual care, and 1341 to usual care alone) were followed up for a mean of 3.7 years. Self-reported physical activity was recorded at baseline, 6-, 24- and 48-months using the Godin-Shepard Leisure Time Exercise Questionnaire (LTEQ). We also determined effects on any limitation of physical activity reported on the physical functioning subscale (PFS) of the 36-item short form questionnaire (SF-36) and proportions of participants reaching guideline recommended physical activity levels.
RESULTS


Among 2601 participants with available data, those in the CPAP group reported significantly more physical activity compared to the usual care group, with approximately 20% higher reported moderate activities on the LTEQ during follow-up (adjusted mean (95% confidence interval [CI]) scores: 8.7, 7.5-9.9 vs 7.3, 6.1-8.5; P = 0.003). The CPAP group also reported less limitation in physical activity (adjusted between-group difference in SF-36 PFS score 1.66, 95% CI 0.87-2.45; P <0.001), and more reported sufficient levels of physical activity to meet recommendations.
CONCLUSIONS


CPAP has positive effects on improving physical activity levels, consistent with long-term health benefits.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov, Name: Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease (SAVE), Identifier: NCT00738179, URL: https://clinicaltrials.gov/ct2/show/NCT00738179 and Registry: Australian New Zealand Clinical Trials Registry, Name: Sleep Apnea CardioVascular Endpoints study - An investigation of continuous positive airway pressure for the treatment of obstructive sleep apnea to prevent cardiovascular disease, Identifier: ACTRN12608000409370, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=83062&isReview=true.",2020,"The CPAP group also reported less limitation in physical activity (adjusted between-group difference in SF-36 PFS score 1.66, 95% CI 0.87-2.45; P <0.001), and more reported sufficient levels of physical activity to meet recommendations.
","['participants with co-occurring cardiovascular disease and OSA.\nMETHODS\n\n\nThe Sleep Apnea cardioVascular Endpoints (SAVE) trial recruited participants with confirmed CV disease history and OSA, 45 - 75 years old', 'https://clinicaltrials.gov/ct2/show/NCT00738179 and Registry', 'obstructive sleep apnea to prevent cardiovascular disease, Identifier', '2687 participants (1346 randomized to', '2601 participants with available data, those in the', 'obstructive sleep apnea with cardiovascular disease', 'those with obstructive sleep apnea (OSA']","['Continuous Positive Airway Pressure Treatment', 'continuous positive airway pressure', 'CPAP plus usual care, and 1341 to usual care alone', 'continuous positive airway pressure (CPAP) treatment', 'CPAP']","['vigorous physical activity levels', 'moderate activities', 'Sleep Apnea CardioVascular Endpoints', 'Self-reported physical activity', 'limitation in physical activity', 'physical activity', 'Godin-Shepard Leisure Time Exercise Questionnaire (LTEQ', 'Obstructive Sleep Apnea', 'physical functioning subscale (PFS', 'SF-36 PFS score', 'physical activity levels']","[{'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2601.0,0.0614092,"The CPAP group also reported less limitation in physical activity (adjusted between-group difference in SF-36 PFS score 1.66, 95% CI 0.87-2.45; P <0.001), and more reported sufficient levels of physical activity to meet recommendations.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stevens', 'Affiliation': 'Adelaide Institute for Sleep Health - A Flinders Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Loffler', 'Affiliation': 'Adelaide Institute for Sleep Health - A Flinders Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Physical Activity Laboratory, Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Yuanming', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, Guangzhou, China.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Lorenzi-Filho', 'Affiliation': 'Instituto do Coracao (Incor) and Hospital Universitario, Sao Paulo, Brazil.'}, {'ForeName': 'Ferran E', 'Initials': 'FE', 'LastName': 'Barbe', 'Affiliation': 'Respiratory Department, IRBLleida, Catalonia, Spain.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'R Doug', 'Initials': 'RD', 'LastName': 'McEvoy', 'Affiliation': 'Adelaide Institute for Sleep Health - A Flinders Centre of Research Excellence, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8792']
2206,32951642,Three-year functional outcome of transosseous-equivalent double-row vs. single-row repair of small and large rotator cuff tears: a double-blinded randomized controlled trial.,"BACKGROUND


The trial aimed to prospectively compare the functional outcomes of patients undergoing arthroscopic rotator cuff repair using transosseous-equivalent double-row (TEDR) or single-row (SR) suture anchor techniques at 3 years postoperatively for both large (>3 cm) and small (<3 cm) tears.
METHODS


Eighty patients with a symptomatic and magnetic resonance imaging (MRI)-proven full-thickness rotator cuff tear, who had failed conservative management of at least 6 months' duration and who had a complete passive range of motion of the affected shoulder, were enrolled in the trial. Patients were randomized to TEDR repair (n = 40) or SR repair (n = 40). Subgroup analysis was conducted for tears <3 cm (TEDR n = 17, SR n = 19) and tears >3 cm (TEDR n = 23, SR n = 21). Primary outcomes included the Oxford Shoulder Score (OSS), the University of California, Los Angeles (UCLA) score, and the Constant-Murley score (CMS). The secondary outcomes included a 0-100-mm visual analog scale (VAS) score for pain, range of motion (ROM), and EQ-5D scores. All patients completed a follow-up of 3 years.
RESULTS


There was a significant difference in the mean OSS postoperative score for tears >3 cm (P = .01) and mean improvement from baseline in the TEDR group (P = .001). For tears >3 cm, mean postoperative scores were also significantly higher in the TEDR group for UCLA (P = .015) and CMS (P = .001). Post hoc testing showed that the differences between these groups was statistically significant (P < .05). For tears <3 cm, a significant postoperative difference in favor of SR repair was seen in the mean CMSs (P = .011), and post hoc testing showed that the difference was statistically significant (P = .015). No significant difference was seen with mean postoperative OSS or UCLA, and post hoc testing did not show a statistically significant difference between groups.
CONCLUSIONS


TEDR repair showed improved functional outcomes for tears >3 cm compared with SR repair. For tears <3 cm, no clear benefit was seen with either technique.",2020,There was a significant difference in the mean OSS postoperative score for tears >3 cm (P = .01) and mean improvement from baseline in the TEDR group (P = .001).,"['patients undergoing', ""Eighty patients with a symptomatic and magnetic resonance imaging (MRI)-proven full-thickness rotator cuff tear, who had failed conservative management of at least 6 months' duration and who had a complete passive range of motion of the affected shoulder, were enrolled in the trial"", 'and large rotator cuff tears']","['SR repair', 'arthroscopic rotator cuff repair using transosseous-equivalent double-row (TEDR) or single-row (SR) suture anchor techniques', 'TEDR repair', 'transosseous-equivalent double-row vs. single-row repair of small', 'TEDR']","['SR repair', 'mean postoperative OSS or UCLA', 'functional outcomes', 'mean CMSs', 'CMS', '0-100-mm visual analog\xa0scale (VAS) score for pain, range of motion (ROM), and EQ-5D scores', 'mean postoperative scores', 'Oxford Shoulder Score (OSS), the University of California, Los Angeles (UCLA) score, and the Constant-Murley score (CMS', 'mean OSS postoperative score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0410017', 'cui_str': 'Full thickness rotator cuff tear'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1720977', 'cui_str': 'Suture Anchors'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",80.0,0.431074,There was a significant difference in the mean OSS postoperative score for tears >3 cm (P = .01) and mean improvement from baseline in the TEDR group (P = .001).,"[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Imam', 'Affiliation': 'Norfolk and Norwich University Hospitals, Norfolk, England; Department of Orthopaedic Surgery and Trauma, Suez Canal University Hospitals, Ismailia, Egypt.'}, {'ForeName': 'Asser', 'Initials': 'A', 'LastName': 'Sallam', 'Affiliation': 'Department of Orthopaedic Surgery and Trauma, Suez Canal University Hospitals, Ismailia, Egypt. Electronic address: assersallam@hotmail.com.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Ernstbrunner', 'Affiliation': 'Department of Orthopaedics, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Boyce', 'Affiliation': 'Bendigo Orthopaedic and Sports Medicine, and University Hospital Geelong, Ryrie and Bellarine Street Geelong, Geelong, VIC, Australia.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Bardakos', 'Affiliation': 'South West London Elective Orthopaedic Centre, Epsom, UK.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Abdelkafy', 'Affiliation': 'Department of Orthopaedic Surgery and Trauma, Suez Canal University Hospitals, Ismailia, Egypt.'}, {'ForeName': 'Moussa', 'Initials': 'M', 'LastName': 'Moussa', 'Affiliation': 'Department of Orthopaedic Surgery and Trauma, Suez Canal University Hospitals, Ismailia, Egypt.'}, {'ForeName': 'Mohamed-Adel', 'Initials': 'MA', 'LastName': 'Ghazal', 'Affiliation': 'Department of Orthopaedic Surgery and Trauma, Suez Canal University Hospitals, Ismailia, Egypt.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.05.005']
2207,32951698,Treatment expectations seem to affect bowel health when using acupuncture during radiotherapy for cancer: Secondary outcomes from a clinical randomized sham-controlled trial.,"OBJECTIVE


To investigate if frequent stools (""diarrhoea""), infrequent stools (""constipation""), capacity in daily activities and Quality of Life (QoL) differed between patients treated with verum or sham acupuncture, and if patients with more positive treatment expectations differed regarding frequent stools and infrequent stools from patients with less positive treatment expectations.
METHODS


In this randomized sham controlled trial, 200 patients received verum traditional penetrating acupuncture or sham acupuncture using a telescopic non-penetrating sham-needle 2-3 times a week during abdominal-pelvic radiotherapy (12 needling sessions during median 5 radiotherapy weeks). The patients registered stool frequency once a week, and registered capacity in daily activities and QoL at the start and end of radiotherapy, and at a one-month follow-up.
RESULTS


In the verum acupuncture group, 29 of 96 answering patients (30 %) experienced frequent stools and 7 (7 %) experienced infrequent stools at least one week of radiotherapy. In the sham acupuncture group, 21 of 97 (22 %) experienced frequent stools (p = 0.175) and 10 (10 %) experienced infrequent stools (p = 0.613). Patients with low treatment expectancy were more likely than other patients to experience frequent stools (60 % versus 26 %, p = 0.014) but not to experience infrequent stools (25 % versus 12 %, p = 0.334).
CONCLUSION


Penetrating acupuncture was not effective for frequent stools or for infrequent stools and did not improve capacity in daily activities or QoL in patients undergoing pelvic-abdominal irradiation for cancer more than non-penetrating acupuncture. Since patients with low acupuncture treatment expectations were more likely to experience frequent stools compared to other patients, non-specific treatment effects warrant further studies.",2020,"CONCLUSION


Penetrating acupuncture was not effective for frequent stools or for infrequent stools and did not improve capacity in daily activities or QoL in patients undergoing pelvic-abdominal irradiation for cancer more than non-penetrating acupuncture.",['200 patients received'],"['verum acupuncture', 'verum or sham acupuncture', 'acupuncture during radiotherapy', 'acupuncture', 'verum traditional penetrating acupuncture or sham acupuncture using a telescopic non-penetrating sham-needle 2-3 times a week during abdominal-pelvic radiotherapy']","['infrequent stools', 'daily activities and Quality of Life (QoL', 'frequent stools', 'experience frequent stools', 'capacity in daily activities or QoL']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0589079', 'cui_str': 'Two to three times a week'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}]","[{'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",200.0,0.295335,"CONCLUSION


Penetrating acupuncture was not effective for frequent stools or for infrequent stools and did not improve capacity in daily activities or QoL in patients undergoing pelvic-abdominal irradiation for cancer more than non-penetrating acupuncture.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Efverman', 'Affiliation': 'Department of Caring Science, Faculty of Health and Occupational Studies, University of Gävle, Gävle, Sweden. Electronic address: anna.efverman@hig.se.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102404']
2208,32951729,"Effects of baru almond oil (Dipteryx alata Vog.) supplementation on body composition, inflammation, oxidative stress, lipid profile, and plasma fatty acids of hemodialysis patients: A randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


The consumption of nuts and edible seeds is associated with the improvement of the metabolic profile and reduction of cardiovascular diseases. However, the effects of its subproducts, such as oil, are still poorly studied. This study aimed to evaluate the effect of the baru almond oil supplementation on inflammation, oxidative stress, body composition, lipid profile, and plasma fatty acids of hemodialysis patients.
METHODS


In a randomized, double-blind, 12-week placebo-controlled clinical study, hemodialysis patients were supplemented with 5 g of baru oil (BG, n = 17) or 5 g of mineral oil (placebo, BP, n = 12). Body composition, renal function, ultra-sensitive C-reactive protein (us-CRP), oxidative stress, plasma fatty acids, and lipid profile were analysed before and after the intervention.
RESULTS


Patients were aged 50.5 ± 2.2 years and the average time of dialyses was 52,1 ± 42,6 months. The BG decreased us-CRP concentration compared to PG (-1.2 ± 0.2 vs. + 0.8 ± 0.2 mg / L,d = 0.88; p =  0.01). Baru almond oil supplementation was not effective in improving body composition, lipid profile, and oxidative stress.
CONCLUSION


Baru almond oil supplementation decreased us-CRP concentration in patients with chronic kidney disease under hemodialysis treatment.",2020,"The BG decreased us-CRP concentration compared to PG (-1.2 ± 0.2 vs. + 0.8 ± 0.2 mg / L,d = 0.88; p =  0.01).","['patients with chronic kidney disease under hemodialysis treatment', 'Patients were aged 50.5\u202f±\u202f2.2 years and the average time of dialyses was 52,1\u202f±\u202f42,6 months', 'hemodialysis patients']","['5\u202fg of baru oil (BG, n\u202f=\u202f17) or 5', 'mineral oil (placebo', 'Baru almond oil supplementation', 'placebo', 'baru almond oil supplementation', 'baru almond oil (Dipteryx alata Vog.) supplementation']","['Body composition, renal function, ultra-sensitive C-reactive protein (us-CRP), oxidative stress, plasma fatty acids, and lipid profile', 'CRP concentration', 'body composition, lipid profile, and oxidative stress', 'body composition, inflammation, oxidative stress, lipid profile, and plasma fatty acids', 'inflammation, oxidative stress, body composition, lipid profile, and plasma fatty acids']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0026156', 'cui_str': 'Mineral Oil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0102271', 'cui_str': 'almond oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1017690', 'cui_str': 'Dipteryx'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.142105,"The BG decreased us-CRP concentration compared to PG (-1.2 ± 0.2 vs. + 0.8 ± 0.2 mg / L,d = 0.88; p =  0.01).","[{'ForeName': 'Raquel M', 'Initials': 'RM', 'LastName': 'Schincaglia', 'Affiliation': 'Laboratório de investigação em nutrição clínica e exercício (Labince), Faculdade de Nutrição, Universidade Federal de Goiás (UFG), Goiânia, GO, 74605-080, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Cuppari', 'Affiliation': 'Departamento de Nefrologia, Universidade Federal de São Paulo e Fundação Oswaldo Ramos, São Paulo, SP, 04021-001, Brazil.'}, {'ForeName': 'Hiasmin F S', 'Initials': 'HFS', 'LastName': 'Neri', 'Affiliation': 'Laboratório de Farmacologia Bioquímica e Molecular, Instituto de Ciências Biológica, Departamento de Farmacologia, Universidade Federal de Goiás (UFG), Goiânia, GO, 74690-090, Brazil.'}, {'ForeName': 'Dennys E', 'Initials': 'DE', 'LastName': 'Cintra', 'Affiliation': 'Laboratório de Genômica Nutricional (LabGeN), Faculdade de Ciências Aplicadas, Universidade Estadual de Campinas (UNICAMP), Limeira, SP, 13484-350, Brazil.'}, {'ForeName': 'Marcella R', 'Initials': 'MR', 'LastName': ""Sant'Ana"", 'Affiliation': 'Laboratório de Genômica Nutricional (LabGeN), Faculdade de Ciências Aplicadas, Universidade Estadual de Campinas (UNICAMP), Limeira, SP, 13484-350, Brazil.'}, {'ForeName': 'João F', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Laboratório de investigação em nutrição clínica e exercício (Labince), Faculdade de Nutrição, Universidade Federal de Goiás (UFG), Goiânia, GO, 74605-080, Brazil. Electronic address: joao_mota@ufg.br.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102479']
2209,32951731,Randomized phase 2 trial of Intravenous Gamma Globulin (IVIG) for the treatment of acute vaso-occlusive crisis in patients with sickle cell disease: Lessons learned from the midpoint analysis.,"Sickle Cell Disease (SCD) is a chronic hemolytic disorder associated with frequent pain episodes, end organ damage and a shortened lifespan. Currently there exist no disease specific targeted therapies for the treatment of acute vaso-occlusive crisis (VOC) and management with analgesics and hydration is purely supportive. Improvement in understanding of disease pathophysiology has resulted in a great interest in disease modifying novel therapies and many are being evaluated in clinical trials. Here we report the results from the pre-specified mid-point analysis of the Phase 2 study of Intravenous Gamma Globulin (IVIG) for the treatment of acute VOC in patients with SCD and lessons learned.",2020,Currently there exist no disease specific targeted therapies for the treatment of acute vaso-occlusive crisis (VOC) and management with analgesics and hydration is purely supportive.,"['patients with sickle cell disease', 'patients with SCD and lessons learned']",['Intravenous Gamma Globulin (IVIG'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017007', 'cui_str': 'Gamma globulin'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}]",[],,0.0648554,Currently there exist no disease specific targeted therapies for the treatment of acute vaso-occlusive crisis (VOC) and management with analgesics and hydration is purely supportive.,"[{'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Manwani', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, United States. Electronic address: dmanwani@montefiore.org.'}, {'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Cell Biology, Albert Einstein College of Medicine, Bronx, NY, United States.'}, {'ForeName': 'Sung Kyun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Cell Biology, Albert Einstein College of Medicine, Bronx, NY, United States.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Amatuni', 'Affiliation': 'Department of Cell Biology, Albert Einstein College of Medicine, Bronx, NY, United States.'}, {'ForeName': 'Hillel W', 'Initials': 'HW', 'LastName': 'Cohen', 'Affiliation': 'Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, United States.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Carullo', 'Affiliation': 'Department of Anesthesiology, Albert Einstein College of Medicine, Bronx, NY, United States.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Morrone', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Davila', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, United States.'}, {'ForeName': 'Patricia Ann', 'Initials': 'PA', 'LastName': 'Shi', 'Affiliation': 'New York Blood Center, New York, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ireland', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, United States.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Keenan', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, United States.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Frenette', 'Affiliation': 'Department of Cell Biology, Albert Einstein College of Medicine, Bronx, NY, United States; Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, United States; Ruth L. and David S. Gottesman Institute for Stem Cell and Regenerative Medicine Research, Albert Einstein College of Medicine, Bronx, NY, United States.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102481']
2210,32951733,The effect of Achillea Millefolium L. on vulvovaginal candidiasis compared with clotrimazole: A randomized controlled trial.,"INTRODUCTION


Vulvovaginal candidiasis is the second most common cause of vulvovaginal infections. The aim of this study is to evaluate the effectiveness of vaginal cream of Achillea millefolium extract in women with vulvovaginal candidiasis in comparison with vaginal clotrimazole.
MATERIALS AND METHODS


This double-blind randomized clinical trial study was conducted on 80 women diagnosed with vulvovaginal candidiasis clinically and by laboratory test; 40 women received vaginal cream clotrimazole 1 % and 40 received vaginal cream containing the aqueous extract of A. millefolium for 7 days. Clinical and laboratory assessments were performed before and after the intervention. Minimum inhibitory concentration of the extract was evaluated with Broth micro-dilution procedure.
RESULTS


The Dermatology life quality index score showed significant reduction in both groups after treatment, but it was significantly more reduced in control group (p < 0.05). Improvement in vulvar erythema was observed in both groups with no statistically difference (p = 0.1). Vaginal culture was negative in term of Candida in 28(77 %) patients of control group and in 18(53 %) patient of experimental group (p < 0.05). The Minimum inhibitory concentration of the extract was 37.5 mg/mL for the standard strain.
DISCUSSION AND CONCLUSION


Study results showed that vaginal cream containing A. millefolium could reduce the complaints of vulvovaginal candidiasis. But, future studies with a larger sample size and different dosages are recommended to assess the outcomes of this new treatment.",2020,"The Dermatology life quality index score showed significant reduction in both groups after treatment, but it was significantly more reduced in control group (p < 0.05).","['80 women diagnosed with vulvovaginal candidiasis clinically and by laboratory test; 40 women received', 'women with vulvovaginal candidiasis in comparison with vaginal clotrimazole']","['vaginal cream clotrimazole 1 % and 40 received vaginal cream containing the aqueous extract of A. millefolium', 'vaginal cream containing A. millefolium', 'vaginal cream of Achillea millefolium extract', 'Achillea Millefolium L', 'clotrimazole']","['Vaginal culture', 'complaints of vulvovaginal candidiasis', 'vulvovaginal candidiasis', 'vulvar erythema', 'Dermatology life quality index score', 'Minimum inhibitory concentration']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}]","[{'cui': 'C0042238', 'cui_str': 'Vaginal cream'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0771936', 'cui_str': 'Yarrow flower extract'}, {'cui': 'C1148469', 'cui_str': 'Yarrow'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0241712', 'cui_str': 'Erythema of vulva'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0427978', 'cui_str': 'MIC'}]",80.0,0.128503,"The Dermatology life quality index score showed significant reduction in both groups after treatment, but it was significantly more reduced in control group (p < 0.05).","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Zakeri', 'Affiliation': 'Fatemeh Zahra Infertility and Reproductive Health Research Center, Babol University of Medical Sciences, Babol, Iran. Electronic address: s.zakeri@mubabol.ac.ir.'}, {'ForeName': 'Seddigheh', 'Initials': 'S', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Fatemeh Zahra Infertility and Reproductive Health Research Center, Babol University of Medical Sciences, Babol, Iran. Electronic address: S.esmaeelzade@mubabol.ac.ir.'}, {'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Gorji', 'Affiliation': 'Traditional Medicine and History of Medical Sciences Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: N.gorji@mubabol.ac.ir.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Memariani', 'Affiliation': 'Traditional Medicine and History of Medical Sciences Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: Z.memariani@mubabol.ac.ir.'}, {'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Moeini', 'Affiliation': 'Traditional Medicine and History of Medical Sciences Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: R.moeini@mubabol.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bijani', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: Alibijani@mubabol.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102483']
2211,32951735,"Educational intervention versus mindfulness-based intervention for ICU nurses with occupational burnout: A parallel, controlled trial.","BACKGROUND


Nurses in the intensive care unit have a high incidence of occupational burnout, which has a serious adverse impact on their physical and mental health. It is imperative, therefore, to explore interventions, especially those that may enhance individual coping resources. Mindfulness has been proven to be one such effective resource. The purpose of this study was to explore the effect of an eight-week mindfulness intervention on occupational burnout in ICU nurses.
METHODS


One hundred six nurses in two ICUs who met the inclusion criteria were recruited to the program, which consisted of an educational intervention related to burnout (EB, n = 53) or a mindfulness-based intervention (MBIB, n = 53), and the results compared. The Maslach Burnout Inventory (MBI), the Mindfulness Attention Awareness Scale (MAAS), and the Acceptance and Action Questionnaire II (AAQ-II) were administered at T0 (before the intervention), T1 (one week after the intervention), T2 (one month after the intervention), and T3 (three months after the intervention). A total of 91 nurses completed the study. Data were analysed by intention-to-treat analysis and repeated-measures ANOVA to observe the effects of the mindfulness-based intervention on occupational burnout.
RESULTS


Nurses' mindfulness, experiential avoidance, emotional exhaustion, depersonalization, and personal accomplishment were all affected by the intervention. The effect could be maintained to the third month post intervention.
CONCLUSION


Mindfulness-based intervention can effectively improve the level of mindfulness and decrease the level of experiential avoidance among ICU nurses, alleviating occupational burnout.",2020,"The Maslach Burnout Inventory (MBI), the Mindfulness Attention Awareness Scale (MAAS), and the Acceptance and Action Questionnaire II (AAQ-II) were administered at T0 (before the intervention), T1 (one week after the intervention), T2 (one month after the intervention), and T3 (three months after the intervention).","['ICU nurses with occupational burnout', '91 nurses completed the study', 'One hundred six nurses in two ICUs who met the inclusion criteria were recruited to the program, which consisted of an educational intervention related to burnout (EB, n\u202f=\u202f53) or a']","['mindfulness-based intervention', 'eight-week mindfulness intervention', 'Educational intervention versus mindfulness-based intervention']","['Maslach Burnout Inventory (MBI), the Mindfulness Attention Awareness Scale (MAAS), and the Acceptance and Action Questionnaire II (AAQ-II', 'level of experiential avoidance', 'experiential avoidance, emotional exhaustion, depersonalization, and personal accomplishment']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0006433', 'cui_str': 'Occupational Burnout'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}]",106.0,0.020366,"The Maslach Burnout Inventory (MBI), the Mindfulness Attention Awareness Scale (MAAS), and the Acceptance and Action Questionnaire II (AAQ-II) were administered at T0 (before the intervention), T1 (one week after the intervention), T2 (one month after the intervention), and T3 (three months after the intervention).","[{'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""Nursing School, West China School of Medicine/West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China; Department of Nursing, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610072, Sichuan, China.""}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'School of Nursing, Chengdu University of Traditional Chinese Medicine, Chengdu, 611137, Sichuan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': ""Healthcare-associated Infection Management Office, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, 610072, Sichuan, China.""}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Nursing, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610072, Sichuan, China.""}, {'ForeName': 'Jingrong', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ""Department of Nursing, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610072, Sichuan, China.""}, {'ForeName': 'Xiuying', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Nursing School, West China School of Medicine/West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China. Electronic address: xiuying_hu@163.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102485']
2212,32951736,Impact of Finnish sauna bathing on circulating markers of inflammation in healthy middle-aged and older adults: A crossover study.,"OBJECTIVES


Finnish sauna bathing is associated with a reduced risk of adverse health outcomes. The acute physiological responses elicited by Finnish sauna bathing that could explain this association remain understudied. This study characterized the acute effect of Finnish sauna bathing on circulating markers of inflammation in healthy middle-aged and older adults.
DESIGN


With the use of a crossover study design, 20 healthy middle-aged and older adults (9 men/11 women, 66 ± 6 years old) performed 3 interventions in random order: 1) 1 x 10 min of Finnish sauna bathing (80 °C, 20 % humidity); 2) 2 x 10 min of Finnish sauna bathing; 3) a time-control period during which participants sat outside of the sauna for 10 min.
MAIN OUTCOMES


Venous blood samples were obtained before (≤15 min) and after (∼65 min) each intervention to determine circulating concentrations of interleukin 6 (IL-6), interleukin 1 receptor antagonist (IL-1RA), and C-reactive protein (CRP).
RESULTS


IL-6 increased in response to 2 x 10 min of sauna bathing (+0.92 pg/mL [+0.16, +1.68], P = 0.02), but not following the 1 x 10 min session (+0.17 pg/mL [-0.13, +0.47], P = 0.26). IL1-RA increased during the 1 x 10 min (+51.27 pg/mL [+20.89, +81.65], P < 0.01) and 2 x 10 min (+30.78 pg/mL [+3.44, +58.12], P = 0.03) sessions. CRP did not change in response to either sauna session (P = 0.34).
CONCLUSION


These results demonstrate that typical Finnish sauna bathing sessions acutely increase IL-6 and IL1-RA in healthy middle-aged and older adults.",2020,"CRP did not change in response to either sauna session (P = 0.34).
","['20 healthy middle-aged and older adults (9 men/11 women, 66\u202f±\u202f6 years old) performed 3 interventions in random order: 1) 1', 'healthy middle-aged and older adults']",['Finnish sauna bathing'],"['IL-6 and IL1-RA', 'IL1-RA', 'CRP', 'IL-6', 'circulating concentrations of interleukin 6 (IL-6), interleukin 1 receptor antagonist (IL-1RA), and C-reactive protein (CRP']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0004836', 'cui_str': 'Sauna'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1704264', 'cui_str': 'Interleukin 1 Inhibitor, Urine'}]",20.0,0.0861761,"CRP did not change in response to either sauna session (P = 0.34).
","[{'ForeName': 'Parya', 'Initials': 'P', 'LastName': 'Behzadi', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montréal, QC, Canada; Department of Pharmacology and Physiology, Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Gravel', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montréal, QC, Canada; Department of Pharmacology and Physiology, Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Paul-Eduard', 'Initials': 'PE', 'LastName': 'Neagoe', 'Affiliation': 'Research Centre, Montreal Heart Institute, Montréal, QC, Canada.'}, {'ForeName': 'Hadiatou', 'Initials': 'H', 'LastName': 'Barry', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montréal, QC, Canada; Department of Pharmacology and Physiology, Faculty of Medicine, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Sirois', 'Affiliation': 'Department of Pharmacology and Physiology, Faculty of Medicine, Université de Montréal, Montréal, QC, Canada; Research Centre, Montreal Heart Institute, Montréal, QC, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gagnon', 'Affiliation': 'Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montréal, QC, Canada; Department of Pharmacology and Physiology, Faculty of Medicine, Université de Montréal, Montréal, QC, Canada; Research Centre, Montreal Heart Institute, Montréal, QC, Canada. Electronic address: daniel.gagnon.3@umontreal.ca.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102486']
2213,32951737,Movie watching during dialysis sessions reduces depression and anxiety and improves quality of life: A randomized clinical trial.,"OBJECTIVE


Evaluate the effect of watching comedy movies as a complementary practice during dialysis on levels of anxiety, depression, quality of life, stress, laboratory findings and intra-dialysis complications.
METHODS


A randomized clinical trial was conducted involving the practice of presenting comedy movies during dialysis. The primary outcome was depression. The secondary outcomes were anxiety, quality of life, stress, laboratory findings and intra-dialysis complications.ResultsTwenty-six patients were in the control group and 35 were in the experimental group. Significant intra-group differences [6.0 to 3.0 (p <0.001) and 8.0 to 4.0 (p <0.001), respectively] and inter-group differences [5.0 vs. 3.0 (p = 0.016) and 7.0 vs. 4.0 (p = 0.017), respectively] were found regarding anxiety and depression scores, with improvements in the experimental group. The experimental group was also less likely to have intra-dialysis complications, such as hypertension (p = 0.003) and headache (p = 0.020), and reported significant improvements in different domains of quality of life [symptoms/problems (p = 0.003); effects of the disease (p = 0.008); pain (p = 0.027); general health state (p = 0.004); and social function (p = 0.036)]. No significant differences were found in salivary cortisol or the results of the biochemical exams, with the exception of a reduction in hematocrit in the control group.ConclusionsThe proposed complementary practice was associated with reductions in anxiety and depression scores and intra-dialysis complications (hypertension and headache) as well as improvements in quality of life in patients with chronic kidney disease.",2020,"The experimental group was also less likely to have intra-dialysis complications, such as hypertension (p = 0.003) and headache (p = 0.020), and reported significant improvements in different domains of quality of life [symptoms/problems (p = 0.003); effects of the disease (p = 0.008); pain (p = 0.027); general health state (p = 0.004); and social function (p = 0.036)].","['practice of presenting comedy movies during dialysis', 'patients with chronic kidney disease']","['Movie watching during dialysis sessions', 'watching comedy movies']","['intra-dialysis complications', 'headache', 'depression and anxiety and improves quality of life', 'quality of life [symptoms/problems', 'pain', 'anxiety, quality of life, stress, laboratory findings and intra-dialysis complications', 'anxiety and depression scores and intra-dialysis complications (hypertension and headache', 'salivary cortisol', 'social function', 'levels of anxiety, depression, quality of life, stress, laboratory findings and intra-dialysis complications', 'quality of life', 'hematocrit', 'depression', 'general health state', 'anxiety and depression scores']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.089925,"The experimental group was also less likely to have intra-dialysis complications, such as hypertension (p = 0.003) and headache (p = 0.020), and reported significant improvements in different domains of quality of life [symptoms/problems (p = 0.003); effects of the disease (p = 0.008); pain (p = 0.027); general health state (p = 0.004); and social function (p = 0.036)].","[{'ForeName': 'Edinara Moraes', 'Initials': 'EM', 'LastName': 'Morais', 'Affiliation': 'Postgraduate Course in Integral Health Care, Regional University of Northwestern Rio Grande Do Sul (UNIJUÍ) and Cruz Alta University (UNICRUZ), Ijuí, Rio Grande Do Sul, Brazil.'}, {'ForeName': 'Paulo Ricardo', 'Initials': 'PR', 'LastName': 'Moreira', 'Affiliation': 'Postgraduate Course in Integral Health Care, Cruz Alta University (UNICRUZ), Rio Grande Do Sul, Brazil.'}, {'ForeName': 'Eliane Roseli', 'Initials': 'ER', 'LastName': 'Winkelmann', 'Affiliation': 'Postgraduate Course in Integral Health Care, Department of Health Sciences, Regional University of Northwestern Rio Grande Do Sul (UNIJUÍ), Ijuí, Rio Grande Do Sul, Brazil. Electronic address: elianew@unijui.edu.br.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102488']
2214,32951743,"Delta-tocotrienol supplementation improves biochemical markers of hepatocellular injury and steatosis in patients with nonalcoholic fatty liver disease: A randomized, placebo-controlled trial.","OBJECTIVE


The aim of this study was to examine the effects of delta-tocotrienol (δ-tocotrienol) supplementation on biochemical markers of hepatocellular injury and steatosis in patients with nonalcoholic fatty liver disease (NAFLD).
DESIGN


The study design was a two-group, randomized, double-blind, placebo-controlled trial. The patients with NAFLD were randomly assigned to receive δ-tocotrienol 300 mg twice daily or placebo for 24 weeks.
ENDPOINTS


The primary endpoints were change from baseline in fatty liver index (FLI) and homeostasis model of insulin resistance (HOMA-IR) after 24 weeks. Secondary endpoints included change from baseline in high sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), alanine transaminase (ALT), aspartate transaminase (AST) and grading of hepatic steatosis on ultrasound. Between-group differences were tested for significance using ANCOVA. Mean differences (MD) with 95 % CIs are reported.
RESULTS


A total of 71 patients (tocotrienol=35, placebo=36) were randomized and included in the intention to treat analysis. Compared with placebo, δ-tocotrienol significantly reduced (MD [95 % CI]) FLI (-8.52 [-10.7, -6.3]; p < 0.001); HOMA-IR (-0.37 [-0.53, -0.21]; p < 0.001), hs-CRP (-0.61[-0.81, -0.42]; p < 0.001), MDA (-0.91 [-1.20, -0.63]; p < 0.001), ALT (-8.86 [-11.5, -6.2]; p < 0.001) and AST (-6.6 [-10.0, -3.08]; p < 0.001). Hepatic steatosis was also reduced by a significantly greater extent with tocotrienol than with placebo (p =0.047). No adverse events were reported.
CONCLUSION


δ-tocotrienol effectively improved biochemical markers of hepatocellular injury and steatosis in patients with NAFLD. δ-tocotrienol supplementation might be considered as a therapeutic option in the management of patients with NAFLD.
TRIAL REGISTRATION


Sri Lankan Clinical Trials Registry (SLCTR/2015/023, 2015-10-03).",2020,Hepatic steatosis was also reduced by a significantly greater extent with tocotrienol than with placebo (p =0.047).,"['patients with NAFLD', 'patients with nonalcoholic fatty liver disease (NAFLD', 'patients with nonalcoholic fatty liver disease', '71 patients (tocotrienol=35, placebo=36']","['Delta-tocotrienol supplementation', 'delta-tocotrienol (δ-tocotrienol) supplementation', 'placebo', 'δ-tocotrienol 300 mg twice daily or placebo', 'δ-tocotrienol supplementation', 'placebo, δ-tocotrienol', 'δ-tocotrienol']","['MDA', 'change from baseline in high sensitivity C-reactive protein (hs-CRP), malondialdehyde (MDA), alanine transaminase (ALT), aspartate transaminase (AST) and grading of hepatic steatosis on ultrasound', 'HOMA-IR', 'adverse events', 'biochemical markers of hepatocellular injury and steatosis', 'hs-CRP', 'Hepatic steatosis', 'change from baseline in fatty liver index (FLI) and homeostasis model of insulin resistance (HOMA-IR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0218003', 'cui_str': 'tocotrienol, delta'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0949647', 'cui_str': 'Tocotrienols'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0151763', 'cui_str': 'Liver damage'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",71.0,0.810324,Hepatic steatosis was also reduced by a significantly greater extent with tocotrienol than with placebo (p =0.047).,"[{'ForeName': 'Muhammad Amjad', 'Initials': 'MA', 'LastName': 'Pervez', 'Affiliation': 'Armed Forces Institute of Pathology, National University of Medical Sciences, Rawalpindi, Pakistan.'}, {'ForeName': 'Dilshad Ahmed', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Armed Forces Institute of Pathology, National University of Medical Sciences, Rawalpindi, Pakistan. Electronic address: dakhan@cpsp.edu.pk.'}, {'ForeName': 'Atiq Ur Rehman', 'Initials': 'AUR', 'LastName': 'Slehria', 'Affiliation': 'Armed Forces Institute of Radiology, National University of Medical Sciences, Rawalpindi, Pakistan.'}, {'ForeName': 'Aamir', 'Initials': 'A', 'LastName': 'Ijaz', 'Affiliation': 'Armed Forces Institute of Pathology, National University of Medical Sciences, Rawalpindi, Pakistan.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102494']
2215,32951744,How adding the abdominal massage to polyethylene glycol can improve symptom and quality of life in patients with functional constipation in comparison with each one of the treatment modalities alone: A randomized clinical trial.,"BACKGROUND


A variety of medical and non-medical treatments have been introduced for functional constipation relief. Here, we aimed to compare the efficacy of a combination of polyethylene glycol (PEG) and abdominal massage with each one of the treatments alone.
MATERIALS AND METHODS


Patients with functional constipation based on Rome IV criteria were randomly assigned into the three treatment groups: group A (abdominal massage for 15 min daily), group B (PEG 20 g daily), and group C (PEG 20 g plus abdominal massage for 15 min daily) for 14 days. PAC-QOL questionnaire, Bristol stool scale were evaluated at baseline and two weeks after treatment. Constipation-associated symptom scores were recorded at baseline, two weeks and four weeks after treatment beginning. Descriptive statistics were provided as the mean ± standard deviation or number and percentage. P-value<0.05 was considered statistically significant.
RESULTS


Forty eight, 47 and 48 patients in group A, B, and C completed the study, respectively. PAC-QOL, Bristol and Constipation-associated symptom scores showed a significant improvement in all study groups two weeks after the treatment compared to the baseline. At the end of treatment, the rate of straining, incomplete evacuation sensation, finger evacuation and the number of defecation was significantly lower in the group C (P < 0.04). Bristol score were significantly improved in group B (P = 0.029) in compare to other groups. The total quality of life score was also significantly improved in the group C (P = 0.028).
CONCLUSION


A combination of abdominal massage and PEG is safe, tolerable and more effective than each one of the treatments alone.",2020,"PAC-QOL, Bristol and Constipation-associated symptom scores showed a significant improvement in all study groups two weeks after the treatment compared to the baseline.","['Forty eight, 47 and 48 patients in group A, B, and C completed the study, respectively', 'patients with functional constipation', 'Patients with functional constipation based on Rome IV criteria']","['polyethylene glycol (PEG) and abdominal massage', 'abdominal massage to polyethylene glycol', 'abdominal massage and PEG', 'group A (abdominal massage for 15\u202fmin daily), group B (PEG 20\u202fg daily), and group C (PEG 20\u202fg plus abdominal massage']","['rate of straining, incomplete evacuation sensation, finger evacuation and the number of defecation', 'Constipation-associated symptom scores', 'symptom and quality of life', 'total quality of life score', 'PAC-QOL, Bristol and Constipation-associated symptom scores', 'PAC-QOL questionnaire, Bristol stool scale', 'Bristol score']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0483249,"PAC-QOL, Bristol and Constipation-associated symptom scores showed a significant improvement in all study groups two weeks after the treatment compared to the baseline.","[{'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mokhtare', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: marjanmokhtare@yahoo.com.'}, {'ForeName': 'Shahdieh', 'Initials': 'S', 'LastName': 'Karimi', 'Affiliation': 'Internal Medicine, Iran University of Medical Sciences, Tehran, Iran. Electronic address: shadi.karimi93@yahoo.com.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Bahardoust', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran; Department of Epidemiology, School of Public Health, Iran University of Medical Science, Tehran, Iran. Electronic address: mansourbahari93@gmail.com.'}, {'ForeName': 'Mohammadjavad', 'Initials': 'M', 'LastName': 'Sotoudeheian', 'Affiliation': 'Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran. Electronic address: so.mohammadjavad1374@gmail.com.'}, {'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Ghazi', 'Affiliation': 'Fellowship of Gastroenterology, Iran University of Medical Sciences, Tehran, Iran. Electronic address: drghazi2017@gmail.com.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Babaei-Ghazani', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Tehran, Iran; Department of Physical Medicine and Rehabilitation, University of Montreal Health Center, Montreal, Canada. Electronic address: babaei-ghazani.a@iums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102495']
2216,32951746,The effect of Quercus (Oak Gal) vaginal cream versus metronidazole vaginal gel on bacterial vaginosis: A double‑blind randomized controlled trial.,"OBJECTIVE


This study was aimed to compare the effect of an Oak Gall extract‑based cream and a metronidazole Gel on the bacterial vaginosis among women in reproductive age.
MATERIAL AND METHODS


This was a double-blind, randomized controlled trial performed on 84 women with BV in reproductive age. Accordingly, the women were randomly assigned to the Oak Gall (n = 42) or metronidazole (n = 42) groups. Diagnosis of BV was confirmed when at least 3 of the 4 Amsel criteria were met by the participants (whitish-grey or thin homogeneous discharge, pH ≥ 4.5, the release of a fishy odor on the addition of 10 % KOH, and detection of clue cells > 20 % in the microscopic examination). For each group, either a methanol extract of Oak Gall vaginal cream or a metronidazole vaginal gel (5 g) was used as intravaginal for 5 consecutive days, and all the signs or symptoms were assessed by passing 4-7 days from the treatment completion.
RESULTS


At baseline, the two groups were homogenous in terms of the vaginal burning, odor, dysuria, dyspareunia, and itching. Also, all women in both groups were free of symptoms (vaginal itching and burning sensation, bad odor, dysuria, and dyspareunia) by passing one week from the intervention (p < 0.001). The percent of bacterial vaginosis treatment was in 33(82.1 %) patients in terms of Oak Gall group and in 34(87.5 %) patients of Metronidazole group (p=0.56). Notably, Oak Gall was as effective and safe as metronidazole in the treatment of BV in reproductive-aged women.
CONCLUSION


Oak Gall could be recommended for women in reproductive age who are uncomfortable with the potential side effects of synthetic drugs.",2020,"At baseline, the two groups were homogenous in terms of the vaginal burning, odor, dysuria, dyspareunia, and itching.","['women in reproductive age', 'reproductive-aged women', '84 women with BV in reproductive age']","['Quercus (Oak Gal) vaginal cream', 'Metronidazole', 'metronidazole vaginal gel', 'methanol extract of Oak Gall vaginal cream or a metronidazole vaginal gel', 'metronidazole', 'Oak Gall extract‑based cream', 'metronidazole Gel']","['effective and safe', 'vaginal burning, odor, dysuria, dyspareunia, and itching', 'percent of bacterial vaginosis treatment', 'free of symptoms (vaginal itching and burning sensation, bad odor, dysuria, and dyspareunia', 'bacterial vaginosis']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0330302', 'cui_str': 'Genus Quercus'}, {'cui': 'C0060993', 'cui_str': 'Galanin'}, {'cui': 'C0042238', 'cui_str': 'Vaginal cream'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C1253511', 'cui_str': 'Metronidazole Vaginal Gel'}, {'cui': 'C0001963', 'cui_str': 'Methanol'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0236083', 'cui_str': 'Burning feeling vagina'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0436342', 'cui_str': 'Free of symptoms'}, {'cui': 'C0042256', 'cui_str': 'Pruritus of vagina'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",84.0,0.335658,"At baseline, the two groups were homogenous in terms of the vaginal burning, odor, dysuria, dyspareunia, and itching.","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Afzali', 'Affiliation': 'Department of Midwifery, Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: afzalielham@yahoo.com.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Siahposh', 'Affiliation': 'Medicinal Plants Research Center and Department of Pharmacognosy, Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: siahpoosh-a@ajums.ac.ir.'}, {'ForeName': 'Mohamad Hossein', 'Initials': 'MH', 'LastName': 'Haghighi-Zadeh', 'Affiliation': 'Department of Statistics, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: mhhaghighy@yahoo.com.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Farajzadeh', 'Affiliation': 'Department of Medical Microbiology, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: farajzadeh-a@ajums.ac.ir.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Abbaspoor', 'Affiliation': 'Department of Midwifery, Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Abbaspoor-z@ajums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102497']
2217,32951751,Development and validation of an evidence-based auricular acupressure intervention for managing chemotherapy-induced nausea and vomiting in breast cancer patients.,"BACKGROUND


Auricular therapy (AT) has been utilized as a promising complementary health approach to alleviating chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients. However, current evidence on AT for CINV management has been inconclusive, and relevant AT treatment protocols have varied considerably in the intervention dosage and acupoint formula without an evidence-informed intervention protocol tailored to CINV symptoms. This study aimed to develop an evidence-based AT intervention protocol for CINV management in breast cancer patients receiving chemotherapy.
METHODS


This study adopted the Medical Research Council Framework for Developing and Evaluating Complex Interventions (the MRC framework) to guide the AT intervention development process. The process consists of four steps: identification of the evidence base, identification of theories and practice standards, identification of cancer symptom characteristics, and modelling and validation. The preliminary AT intervention was then evaluated through a content validity study to identify its theoretical and practical appropriateness. The content validity index (CVI) was used to determine the consensus level of the panel.
RESULTS


A preliminary AT intervention protocol, including a true AT intervention and a sham AT intervention, was developed based on research evidence identified from five systematic reviews, the homuncular reflex theory, the zang-fu organs and meridian theory, relevant AT practice standards, and the natural symptom progress of CINV. The true AT was designed as a daily manual acupressure for five consecutive days. While the sham AT was designed with the same intervention duration and acupoint formula as the true AT without manual acupressure. The content validity study demonstrated excellent consensus among the expert panel to support the AT intervention as a theoretically and practically feasible program with the item-level CVI ranging from 0.83 to 1.0 and the scale-level CVI reaching 1.0.
CONCLUSION


This study followed the MRC framework to develop an evidence-based AT intervention for CINV management which is well supported by systematic review research evidence, AT theories and practice standards, CINV symptom characteristics, and expert panel consensus. The AT intervention would be further evaluated in a pilot randomised controlled trial to confirm its utility, feasibility and acceptability in clinical settings.",2020,"The content validity study demonstrated excellent consensus among the expert panel to support the AT intervention as a theoretically and practically feasible program with the item-level CVI ranging from 0.83 to 1.0 and the scale-level CVI reaching 1.0.
","['breast cancer patients receiving chemotherapy', 'breast cancer patients']","['auricular acupressure intervention', 'Auricular therapy (AT']","['nausea and vomiting', 'nausea and vomiting (CINV', 'content validity index (CVI']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0472058,"The content validity study demonstrated excellent consensus among the expert panel to support the AT intervention as a theoretically and practically feasible program with the item-level CVI ranging from 0.83 to 1.0 and the scale-level CVI reaching 1.0.
","[{'ForeName': 'Jing-Yu', 'Initials': 'JY', 'LastName': 'Tan', 'Affiliation': 'The Hong Kong Polytechnic University, School of Nursing, Hung Hom, Kowloon, Hong Kong Special Administrative Region; Charles Darwin University, College of Nursing and Midwifery Brisbane Centre, Level 11, 410 Ann Street, Brisbane, QLD, 4000, Australia. Electronic address: benjamin.tan@cdu.edu.au.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Fujian Provincial Cancer Hospital, Department of Breast Oncology, Fuma Road, Jinan District, Fuzhou, Fujian, 340014, China.'}, {'ForeName': 'Lorna K P', 'Initials': 'LKP', 'LastName': 'Suen', 'Affiliation': 'The Hong Kong Polytechnic University, School of Nursing, Hung Hom, Kowloon, Hong Kong Special Administrative Region.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Molassiotis', 'Affiliation': 'The Hong Kong Polytechnic University, School of Nursing, Hung Hom, Kowloon, Hong Kong Special Administrative Region.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'The Hong Kong Polytechnic University, School of Nursing, Hung Hom, Kowloon, Hong Kong Special Administrative Region; Charles Darwin University, College of Nursing and Midwifery Brisbane Centre, Level 11, 410 Ann Street, Brisbane, QLD, 4000, Australia.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102502']
2218,32951754,The effects of eugenol nanoemulsion on pain caused by arteriovenous fistula cannulation in hemodialysis patients: A randomized double-blinded controlled cross-over trial.,,2020,,['hemodialysis patients'],['eugenol nanoemulsion'],['pain'],"[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015153', 'cui_str': 'Eugenol'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.418149,,"[{'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Mansori', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran. Electronic address: kamyarmansori@yahoo.com.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Soltani-Kermanshahi', 'Affiliation': 'Social Determinants of Health Research Center, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: msoltani@semums.ac.ir.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102506']
2219,32951763,Hypoglycemic efficacy and safety of Momordica charantia (bitter melon) in patients with type 2 diabetes mellitus.,"INTRODUCTION


Momordica charantia (bitter melon) is widely used for its glucose-lowering effects. This study was conducted to assess the efficacy and safety of M. charantia as an adjuvant treatment in patients with type 2 diabetes.
METHODS


We performed a randomized, placebo-controlled study. Blood glucose levels, lipid profile, and adverse events were investigated after 12 weeks of treatment. Ninety subjects were included in the final analysis for glucose lowering efficacy of bitter melon.
RESULTS


There were no differences in age, sex, or glycated hemoglobin (HbA1c) levels between the bitter melon extract and placebo groups. After treatment with bitter melon extract for 12 weeks, the HbA1c levels of the bitter melon and placebo groups remained unchanged; however, the average fasting glucose level of the bitter melon group decreased (p = 0.014). No serious adverse events were reported during the treatment period.
CONCLUSIONS


Our data showed that bitter melon has effects of glucose lowering in patients with type 2 diabetes.",2020,"There were no differences in age, sex, or glycated hemoglobin (HbA1c) levels between the bitter melon extract and placebo groups.","['patients with type 2 diabetes mellitus', 'patients with type 2 diabetes', 'Ninety subjects were included in the final analysis for glucose lowering efficacy of bitter melon']","['Momordica charantia (bitter melon', 'placebo']","['average fasting glucose level', 'age, sex, or glycated hemoglobin (HbA1c) levels', 'Hypoglycemic efficacy and safety', 'efficacy and safety', 'Blood glucose levels, lipid profile, and adverse events', 'HbA1c levels', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0330482', 'cui_str': 'Momordica charantia'}]","[{'cui': 'C0330482', 'cui_str': 'Momordica charantia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",90.0,0.0801362,"There were no differences in age, sex, or glycated hemoglobin (HbA1c) levels between the bitter melon extract and placebo groups.","[{'ForeName': 'Soo Kyoung', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea; Institute of Health Sciences, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Institute of Health Sciences, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea; Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea.'}, {'ForeName': 'Jung Hwa', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea; Institute of Health Sciences, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea.'}, {'ForeName': 'NalAe', 'Initials': 'N', 'LastName': 'Yoon', 'Affiliation': 'Institute of Health Sciences, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea; Department of Anatomy and Neurobiology, Institute of Health Sciences, Gyeongsang National University School of Medicine, Jinju, 52727, Gyeongnam, Republic of Korea.'}, {'ForeName': 'Sang Soo', 'Initials': 'SS', 'LastName': 'Kang', 'Affiliation': 'Institute of Health Sciences, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea; Department of Anatomy and Neurobiology, Institute of Health Sciences, Gyeongsang National University School of Medicine, Jinju, 52727, Gyeongnam, Republic of Korea.'}, {'ForeName': 'Gu Seob', 'Initials': 'GS', 'LastName': 'Roh', 'Affiliation': 'Institute of Health Sciences, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea; Department of Anatomy and Neurobiology, Institute of Health Sciences, Gyeongsang National University School of Medicine, Jinju, 52727, Gyeongnam, Republic of Korea.'}, {'ForeName': 'Jong Ryeal', 'Initials': 'JR', 'LastName': 'Hahm', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea; Institute of Health Sciences, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Republic of Korea. Electronic address: jrhahm@gnu.ac.kr.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102524']
2220,32951766,"The Acute Effects of Manual and Instrument-Assisted Cervical Spine Manipulation on Pressure Pain Threshold, Pressure Pain Perception, and Muscle-Related Variables in Asymptomatic Subjects: A Randomized Controlled Trial.","OBJECTIVE


The purpose of this study was to compare the immediate effects in asymptomatic participants of manual and instrument-assisted cervical manipulation on pressure pain thresholds, pressure pain perception, and muscle mechanical properties (tone, stiffness, and elasticity) over muscles anatomically related and unrelated to the manipulated level.
METHODS


Fifty-nine asymptomatic participants (34 women and 25 men; age [mean ± standard deviation] = 21.1 ± 1.6 years) were randomly assigned to 4 groups in a double-blind, randomized, placebo-controlled trial. Two groups received cervical (C3/C4) manipulation, 1 manual and the other instrument-assisted; the third group received a sham manipulation; and the fourth group served as the control. Bilateral pressure pain threshold, pressure pain perception, muscle tone, stiffness, and elasticity in the upper trapezius and biceps brachii were evaluated before and immediately after the interventions.
RESULTS


At baseline, there were no differences among the groups on any variable. After the interventions, a significant increase in pressure pain threshold was observed with both manual and instrument-assisted manipulation at local and distal sites (P < .05), whereas no changes were observed in either the control or the placebo group. The perception of pain pressure did not change significantly in any group. The interventions did not promote any statistically significant differences in muscle tone, elasticity, or stiffness at any site (local or distal).
CONCLUSION


Cervical (C3/C4) manual and instrument-assisted manipulations produced an increase in pressure pain threshold bilaterally and over muscles related and unrelated to the vertebral segment, but had no effect on muscle tone, elasticity, or stiffness.",2020,"The interventions did not promote any statistically significant differences in muscle tone, elasticity, or stiffness at any site (local or distal).
","['asymptomatic participants of', 'Asymptomatic Subjects', 'Fifty-nine asymptomatic participants (34 women and 25 men; age [mean ± standard deviation]\u202f=\u202f21.1 ± 1.6 years']","['Manual and Instrument-Assisted Cervical Spine Manipulation', 'placebo', 'Cervical (C3/C4) manual and instrument-assisted manipulations', 'cervical (C3/C4) manipulation, 1 manual and the other instrument-assisted; the third group received a sham manipulation', 'manual and instrument-assisted cervical manipulation']","['pressure pain threshold', 'Bilateral pressure pain threshold, pressure pain perception, muscle tone, stiffness, and elasticity in the upper trapezius and biceps brachii', 'perception of pain pressure', 'pressure pain thresholds, pressure pain perception, and muscle mechanical properties (tone, stiffness, and elasticity', 'Pressure Pain Threshold, Pressure Pain Perception, and Muscle-Related Variables', 'muscle tone, elasticity, or stiffness', 'pressure pain', 'muscle tone, elasticity, or stiffness at any site (local or distal']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0203928', 'cui_str': 'Manipulation of the cervical spine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0600576', 'cui_str': 'Neck manipulation'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205108', 'cui_str': 'Distal'}]",59.0,0.148268,"The interventions did not promote any statistically significant differences in muscle tone, elasticity, or stiffness at any site (local or distal).
","[{'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Nogueira', 'Affiliation': 'Vale do Sousa Higher School of Health, Polytechnic Health School of the North, Cooperativa de Ensino Superior Politécnico e Universitário (CESPU), Gandra, Portugal; Physiotherapy Department, School of Health, Polytechnic Institute of Porto, Center for Rehabilitation Research-Center of Human Studies and Human Activity, Porto, Portugal. Electronic address: nunogueira@gmail.com.'}, {'ForeName': 'Natália', 'Initials': 'N', 'LastName': 'Oliveira-Campelo', 'Affiliation': 'Physiotherapy Department, School of Health, Polytechnic Institute of Porto, Center for Rehabilitation Research-Center of Human Studies and Human Activity, Porto, Portugal.'}, {'ForeName': 'Ângela', 'Initials': 'Â', 'LastName': 'Lopes', 'Affiliation': 'Physiotherapy Department, School of Health, Polytechnic Institute of Porto, Center for Rehabilitation Research-Center of Human Studies and Human Activity, Porto, Portugal.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Torres', 'Affiliation': 'Vale do Sousa Higher School of Health, Polytechnic Health School of the North, Cooperativa de Ensino Superior Politécnico e Universitário (CESPU), Gandra, Portugal; Physiotherapy Department, School of Health, Polytechnic Institute of Porto, Center for Rehabilitation Research-Center of Human Studies and Human Activity, Porto, Portugal.'}, {'ForeName': 'Andreia S P', 'Initials': 'ASP', 'LastName': 'Sousa', 'Affiliation': 'Physiotherapy Department, School of Health, Polytechnic Institute of Porto, Center for Rehabilitation Research-Center of Human Studies and Human Activity, Porto, Portugal.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': 'School of Health Sciences and Institute of Biomedicine (iBiMED), University of Aveiro, Aveiro, Portugal.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.05.007']
2221,32951780,"Red light: A novel, non-pharmacological intervention to promote alertness in shift workers.","INTRODUCTION


Night work requires inversion of the natural, diurnal human activity-rest cycle and is associated with decreased alertness and some measures of performance, reduced safety, adverse health effects, and chronic disruption of the melatonin cycle that has been associated with increased risk for several major diseases. Previous studies show that red light exposures at night can promote alertness and improve performance while not negatively affecting melatonin secretion.
METHOD


This ongoing crossover, mixed (within- and between-subjects) design field study is testing the efficacy and acceptance of red light delivered to day-shift and night-shift workers using personal light glasses while they are at work. Each participant experienced three lighting interventions at the eyes: red light (50 lx, 630 nm, the treatment intervention), blue light (50 lx, 460 nm, the positive control intervention), and dim white light (10 lx, 3,000 K, the placebo control). During the interventions, participants underwent visual performance testing, submitted salivary melatonin and cortisol samples, and provided subjective reports of sleepiness, sleep disturbance, and general health over the 20-week protocol. Due to the ongoing nature of the study, only the performance and subjective reports are presented here.
RESULTS


Preliminary results indicate that response times were improved by the red and blue interventions, but not accuracy and hit rates. Blue light was associated with improvements to self-reported sleep disturbances compared to dim light.
CONCLUSIONS


These field results partially support our laboratory results that showed a positive effect of red light for promoting alertness and certain performance outcomes during the day and at night. Practical Applications: Red light may be used to improve response times in shift workers. Continued research will elucidate the lighting interventions' effects on melatonin and objective sleep measures (actigraphy).",2020,"Blue light was associated with improvements to self-reported sleep disturbances compared to dim light.
",['shift workers'],"['lighting interventions at the eyes: red light (50\u202flx, 630\u202fnm, the treatment intervention), blue light (50\u202flx, 460\u202fnm, the positive control intervention), and dim white light', 'Red light']","['response times', 'sleep disturbances', 'accuracy and hit rates', 'melatonin and objective sleep measures (actigraphy']","[{'cui': 'C0425104', 'cui_str': 'Shift worker'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0303896', 'cui_str': 'Blue light'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0563228', 'cui_str': 'White light'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}]",3000.0,0.0148726,"Blue light was associated with improvements to self-reported sleep disturbances compared to dim light.
","[{'ForeName': 'Mariana G', 'Initials': 'MG', 'LastName': 'Figueiro', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, 21 Union Street, Troy, NY 12280, United States. Electronic address: figuem@rpi.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pedler', 'Affiliation': 'Lighting Research Center, Rensselaer Polytechnic Institute, 21 Union Street, Troy, NY 12280, United States.'}]",Journal of safety research,['10.1016/j.jsr.2020.06.003']
2222,32951794,Efficacy of text messaging apprentices to reinforce ergonomics and safety voice training.,"INTRODUCTION


Injuries and work-related musculoskeletal disorders (MSDs) are common among masons. SAfety Voice for Ergonomics (SAVE) integrates training in ergonomic and safety problem-solving skills into masonry apprenticeship training. The purpose of this study was to assess the efficacy of text messaging to reinforce SAVE program content.
METHOD


SAVE effectiveness was evaluated at masonry apprenticeship training centers across the United States by comparing three experimental groups: (1) Ergonomics training, (2) Ergonomics and Safety Voice training, and a (3) Control. Apprentices received SAVE training with their standard instruction. To reinforce classroom training, refresher training was implemented by sending weekly text messages for six months. Half of the text messages required a response, which tested knowledge or assessed behavior, while the remaining reiterated knowledge. Apprentices (n = 119) received SAVE text messages. Response rates and percentage of correct responses were compared with chi-square tests and independent group t-tests. Multivariable logistic regression analysis predicted apprentice response with selected demographic and work experience variables. Finally, feedback on of the use of text messaging was obtained.
RESULT


Of 119 participants, 61% (n = 72) responded to at least one text message. Logistic regression revealed that being a high school graduate and a brick and block mason significantly affected the odds of responding. Sixty-nine percent of apprentices agreed that text messages reinforced SAVE content.
CONCLUSION


Even though there was no training center requirement to respond, the high response rate suggests that text messaging can effectively be used to reinforce ergonomics and safety voice training for both knowledge and behavior. Practical Application: The prevalent use of text messaging creates opportunities to reinforce health and safety training and engage workers, especially for populations that may be at various locations over time such as construction sites. Instructors and practitioners should consider the utility of text messaging for supporting their training and safety programs.",2020,Logistic regression revealed that being a high school graduate and a brick and block mason significantly affected the odds of responding.,[],"['SAVE text messages', 'SAVE training with their standard instruction', 'Ergonomics training, (2) Ergonomics and Safety Voice training, and a (3) Control']",['Response rates and percentage of correct responses'],[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042944', 'cui_str': 'Voice training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",119.0,0.0238435,Logistic regression revealed that being a high school graduate and a brick and block mason significantly affected the odds of responding.,"[{'ForeName': 'Laurel D', 'Initials': 'LD', 'LastName': 'Kincl', 'Affiliation': 'College of Public Health and Human Sciences, Oregon State University, Corvallis, OR, USA. Electronic address: laurel.kincl@oregonstate.edu.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Hess', 'Affiliation': 'Labor Education and Research Center, University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Weeks', 'Affiliation': ""Department of Rehabilitation Research, St. Luke's Rehabilitation Institute, Spokane, WA, USA.""}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Vaughan', 'Affiliation': 'College of Public Health and Human Sciences, Oregon State University, Corvallis, OR, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Anton', 'Affiliation': 'Department of Physical Therapy, Eastern Washington University, Spokane, WA, USA.'}]",Journal of safety research,['10.1016/j.jsr.2020.04.007']
2223,32951870,Retention of removable complete dentures made with different posterior palatal seal techniques and oral health quality of life: A clinical study.,"STATEMENT OF PROBLEM


How different methods of recording posterior palatal seal affect removable complete-denture retention and oral health quality of life is unclear.
PURPOSE


The purpose of this clinical study was to compare the retention and oral health quality of life (OHIP-14) between conventional and arbitrary posterior palatal seal techniques in participants with removable complete dentures.
MATERIAL AND METHODS


Edentulous patients were recruited according to definitive criteria. The participants were randomly divided into conventional and arbitrary seal. After the delivery of the denture, the retention was evaluated with a force gauge dynamometer and at 3, 6, 9, and 12 months. Denture satisfaction was evaluated with the OHIP-14 questionnaire. Data were statistically analyzed by using the t test and repeated measure ANOVA (α=.05).
RESULTS


The mean ±standard deviation values (N) for conventional seal at 0, 3, 6, 9, and 12 months by dynamometer in the anterior region ranged from 4.73 ±0.78 to 4.90 ±0.81 and in the posterior region between 5.07 ±0.84 and 5.31 ±0.99. Dynamometer values for arbitrary seal in the anterior region were from 4.56 ±0.77 to 4.88 ±0.81, and in the posterior, it varied between 4.74 ±0.74 and 5.15 ±0.81. Force gauge values (N) for conventional and arbitrary seal were in the range of 18.35 ±2.84 to 20.69 ±3.89. The general mean ±SD OHIP-14 was higher for the conventional seal at 3.12 ±0.25 than for the arbitrary seal at 2.73 ±0.23 The difference between the conventional and arbitrary seal techniques was not statistically significant (P>.05) CONCLUSIONS: No significant difference in complete denture retention was detected between the 2 posterior palatal seal techniques. Oral health quality of life was higher with the conventional seal technique.",2020,The difference between the conventional and arbitrary seal techniques was not statistically significant ,"['participants with removable complete dentures', 'Edentulous patients were recruited according to definitive criteria']","['conventional and arbitrary posterior palatal seal techniques', 'conventional and arbitrary seal']","['mean ±standard deviation values (N) for conventional seal', 'Denture satisfaction', 'retention and oral health quality of life (OHIP-14', 'Oral health quality of life', 'oral health quality of life', 'complete denture retention', 'Dynamometer values', 'Force gauge values (N) for conventional and arbitrary seal', 'general mean ±SD OHIP-14']","[{'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0494118,The difference between the conventional and arbitrary seal techniques was not statistically significant ,"[{'ForeName': 'Sanjana Rebecca', 'Initials': 'SR', 'LastName': 'Tharakan', 'Affiliation': 'Postgraduate student, Department of Prosthodontics, Sri Ramaswami Memorial Dental College, Ramapuram, India.'}, {'ForeName': 'Naveen Gopi', 'Initials': 'NG', 'LastName': 'Chander', 'Affiliation': 'Professor, Department of Prosthodontics, Sri Ramaswami Memorial Dental College, Ramapuram, India. Electronic address: drgopichander@gmail.com.'}, {'ForeName': 'Kuttae Viswanathan', 'Initials': 'KV', 'LastName': 'Anitha', 'Affiliation': 'Reader, Department of Prosthodontics, Sri Ramaswami Memorial Dental College, Ramapuram, India.'}, {'ForeName': 'Muthukumar', 'Initials': 'M', 'LastName': 'Balasubramaniam', 'Affiliation': 'Professor & Head, Department of Prosthodontics, Sri Ramaswami Memorial Dental College, Ramapuram, India.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.08.005']
2224,32951928,"Re: Fredrik Liedberg, Petter Kollberg, Marie Allerbo, et al. Preventing Parastomal Hernia After Ileal Conduit by the Use of a Prophylactic Mesh: A Randomised Study. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.07.033.",,2020,,[],[],['Parastomal Hernia'],[],[],"[{'cui': 'C0341539', 'cui_str': 'Parastomal hernia'}]",,0.0222472,,"[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ghoreifi', 'Affiliation': 'Institute of Urology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Djaladat', 'Affiliation': 'Institute of Urology, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA. Electronic address: djaladat@med.usc.edu.'}]",European urology,['10.1016/j.eururo.2020.09.022']
2225,32951965,Immediate dental implant placement with a horizontal gap more than two millimetres: a randomized clinical trial.,"The purpose of this study was to evaluate the horizontal dimensional changes in buccal alveolar bone immediately after dental implant placement in the upper premolar area with horizontal gaps >2mm. A total of 48 patients were enrolled in this randomized clinical trial and were randomly assigned to one of three groups. Group I (flap with graft; n=16) patients received an immediate implant with bone graft, membrane, and primary flap closure. Group II (flap without graft; n=16) patients received an immediate implant with primary flap closure only. Group III (flapless without graft; n=16) patients received an immediate implant without graft, membrane, or primary closure. Cone beam computed tomography (CBCT) scans were obtained preoperatively, immediately after implant placement, and at 6 months postoperative to evaluate horizontal dimensional changes in the buccal alveolar bone. Pain intensity was measured using a numerical rating scale. CBCT examinations revealed that bone had filled the horizontal gap in all three groups. Group II showed the greatest horizontal dimensional changes in the buccal alveolar bone, followed by group I. The least amount of change was recorded for group III. Furthermore, significantly less postoperative pain was recorded in group III when compared to the other groups. Short-term results suggest that the 'flapless without graft' technique shows similar results to the 'flap with graft technique' for immediate implant placement in the maxillary premolar extraction site with a horizontal gap >2mm, when the bone plate is intact.",2020,"Group II showed the greatest horizontal dimensional changes in the buccal alveolar bone, followed by group I. The least amount of change was recorded for group III.","['A total of 48 patients', 'n=16) patients received an', 'buccal alveolar bone immediately after dental implant placement in the upper premolar area with horizontal gaps >2mm']","['immediate implant with bone graft, membrane, and primary flap closure', 'immediate implant with primary flap closure only', 'Immediate dental implant placement', 'Cone beam computed tomography (CBCT) scans', 'immediate implant without graft, membrane, or primary closure']","['Pain intensity', 'postoperative pain']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",48.0,0.0295061,"Group II showed the greatest horizontal dimensional changes in the buccal alveolar bone, followed by group I. The least amount of change was recorded for group III.","[{'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Naji', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Abdelsameaa', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Alqutaibi', 'Affiliation': 'Prosthodontics Department, College of Dentistry, Taibah University, Al Madinah Al Munawwarah, Saudi Arabia; Prosthodontics Department, College of Dentistry, Ibb University, Ibb, Yemen. Electronic address: Alqutaibiprosthodontist@gmail.com.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Said Ahmed', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.08.015']
2226,32951999,Sublingual Sufentanil Tablet System Versus Continuous Morphine Infusion for Postoperative Analgesia in Cardiac Surgery Patients.,"OBJECTIVE(S)


To assess the effectiveness and side effects of a patient-controlled sublingual sufentanil tablet system for postoperative analgesia after cardiac surgery and to compare it to a nurse-controlled continuous morphine infusion.
DESIGN


Prospective, open-label, randomized controlled trial.
SETTING


Single university academic center.
PARTICIPANTS


Adult patients undergoing cardiac surgery, which included a sternotomy.
INTERVENTIONS


Sublingual sufentanil tablet system versus nurse-controlled continuous morphine infusion.
MEASUREMENTS AND MAIN RESULTS


A total of 483 cardiac surgery patients were screened for eligibility, of whom 64 patients completed the study. No statistically significant differences were found for baseline characteristics between both groups. All mean numeric rating scale (NRS) pain scores from after extubation until intensive care unit discharge were ≤3 in both groups. The cumulative mean NRS pain score from 24 hours after extubation (primary outcome) (t = hours after extubation) was significantly different in favor of the morphine group: (t = 0-24) (0.8 [0.7] v 1.3 [0.8]; p = 0.006). Later cumulative mean pain scores were also in favor of the morphine group: (t = 24-48) (0.2 [0.3] v 0.6 [0.5]; p = 0.001) and (t = 48-63) (0.0 [0.0] v 0.1 [0.2]; p = 0.013). The cumulative opioid dose (in milligrams intravenous morphine equivalents) was significantly higher in the morphine group compared with the sublingual sufentanil group (241.94 [218.73] v 39.84 [21.96]; p = 0.0001). No differences were found for the incidences of postoperative nausea and vomiting, sedation, hypoventilation, bradycardia, or hypotension between both groups (secondary outcomes).
CONCLUSIONS


Despite resulting in statistically significantly higher pain scores, a patient-controlled sublingual sufentanil tablet system offers adequate analgesia after cardiac surgery and reduces opioid consumption when compared with continuous morphine infusion.",2020,"No differences were found for the incidences of postoperative nausea and vomiting, sedation, hypoventilation, bradycardia, or hypotension between both groups (secondary outcomes).
","['postoperative analgesia after cardiac surgery', 'Cardiac Surgery Patients', 'Single university academic center', 'Adult patients undergoing cardiac surgery, which included a sternotomy', '483 cardiac surgery patients were screened for eligibility, of whom 64 patients completed the study']","['Sublingual sufentanil tablet system versus nurse-controlled continuous morphine infusion', 'Sublingual Sufentanil Tablet System Versus Continuous Morphine Infusion', 'sublingual sufentanil', 'morphine']","['cumulative opioid dose', 'cumulative mean NRS pain score', 'postoperative nausea and vomiting, sedation, hypoventilation, bradycardia, or hypotension', 'All mean numeric rating scale (NRS) pain scores', 'Later cumulative mean pain scores', 'opioid consumption', 'pain scores']","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C3203358', 'cui_str': 'Hypoventilation'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",483.0,0.192892,"No differences were found for the incidences of postoperative nausea and vomiting, sedation, hypoventilation, bradycardia, or hypotension between both groups (secondary outcomes).
","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Van Tittelboom', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, UZ Brussels, Jette, Belgium. Electronic address: vincentvantittelboom@gmail.com.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Poelaert', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, UZ Brussels, Jette, Belgium.'}, {'ForeName': 'Manu L N G', 'Initials': 'MLNG', 'LastName': 'Malbrain', 'Affiliation': 'Department of Intensive Care, UZ Brussels, Faculty of Medicine and Pharmacy, Jette, Belgium.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'La Meir', 'Affiliation': 'Department of Cardiac Surgery, UZ Brussels, Faculty of Medicine and Pharmacy, Jette, Belgium.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Staessens', 'Affiliation': 'Department of Perfusion, UZ Brussels, Jette, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Poelaert', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, UZ Brussels, Faculty of Medicine and Pharmacy, Jette, Belgium.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.08.030']
2227,32952009,Treatment of Chronic Kidney Disease-Related Metabolic Acidosis With Fruits and Vegetables Compared to NaHCO 3  Yields More and Better Overall Health Outcomes and at Comparable Five-Year Cost.,"OBJECTIVES


Current guidelines recommend treatment of metabolic acidosis in chronic kidney disease (CKD) with Na + -based alkali but base-producing fruits and vegetables (F + V) might yield more and better health outcomes, making the intervention cost-effective.
DESIGN AND METHODS


In this post hoc analysis of a clinical trial we randomized 108 macroalbuminuric, nondiabetic CKD stage 3 participants with metabolic acidosis to receive F + V (n = 36) calculated to reduce dietary acid by half, oral NaHCO 3  (HCO 3 - , n = 36) 0.3 mEq/kg body weight/day, or Usual Care (UC, n = 36) assessed annually for 5 years. We calculated a mean overall health score for the groups as follows: 1 for improved, 0 for no change, and -1 for worsened at 5 years for plasma total CO 2 , low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, change in medication dose (reduction = 1, increased = -1, no change = 0), and 1 for met goal and 0 for not meeting goal for estimated glomerular filtration rate (>30 mL/min/1.73 m 2 ) and systolic blood pressure (<130 mm Hg). We also assessed the number of participants with cardiovascular disease events (myocardial infarctions + strokes) and group medication and hospitalization costs.
RESULTS


Net plasma total CO 2  increase at 5 years was no different between HCO 3 -  and F + V. Average health scores at 5 years differed among groups (P < .01) with F + V (7.4 [mean] ± 1.6 [standard deviation]) being descriptively larger than HCO 3 -  and UC (2.9 ± 1.6 and 1.2 ± 1.6, respectively). The number of participants suffering cardiovascular disease events differed among groups (P = .009) with none (0) in F + V, 6 in UC, and 2 in HCO 3 - . Total 5-year household cost per beneficial health outcome differed among groups (P = .005) with UC being highest and that for HCO 3 -  and F + V being comparable.
CONCLUSIONS


Metabolic acidosis improved comparably with F + V or standard oral NaHCO 3 , but F + V yielded ancillary beneficial health outcomes, fewer participants with adverse cardiovascular events, and per-household cost that was comparable to NaHCO 3 .",2020,"The number of participants suffering cardiovascular disease events differed among groups (P = .009) with none (0) in F + V, 6 in UC, and 2 in HCO 3 - .","['108 macroalbuminuric, nondiabetic CKD stage 3 participants with metabolic acidosis to receive', 'participants with cardiovascular disease events (myocardial infarctions\xa0+\xa0strokes) and group medication and hospitalization costs']","['F\xa0+\xa0V (n\xa0=\xa036) calculated to reduce dietary acid by half, oral NaHCO 3  (HCO 3 - , n\xa0=\xa036) 0.3 mEq/kg body weight/day, or Usual Care (UC, n\xa0=\xa036) assessed annually for 5\xa0years']","['mean overall health score', 'Metabolic acidosis', 'glomerular filtration rate', 'plasma total CO 2 , low-density lipoprotein cholesterol, high-density lipoprotein cholesterol', 'Overall Health Outcomes', 'health scores', 'systolic blood pressure', 'Total 5-year household cost per beneficial health outcome', 'number of participants suffering cardiovascular disease events']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0560587', 'cui_str': 'mEq/kg body weight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",108.0,0.0496378,"The number of participants suffering cardiovascular disease events differed among groups (P = .009) with none (0) in F + V, 6 in UC, and 2 in HCO 3 - .","[{'ForeName': 'Nimrit', 'Initials': 'N', 'LastName': 'Goraya', 'Affiliation': 'Department of Internal Medicine, Texas A&M College of Medicine, Temple, Texas; Department of Internal Medicine, Baylor Scott and White Health, Temple, Texas.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Munoz-Maldonado', 'Affiliation': 'Statistical Savvy Consulting, Georgetown, Texas.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Simoni', 'Affiliation': 'Department of Surgery, Texas Tech University Health Sciences Center, Lubbock, Texas.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Wesson', 'Affiliation': 'Department of Internal Medicine, Texas A&M Health Sciences Center College of Medicine, Dallas, Texas; Baylor Scott and White Health and Wellness Center, Dallas, Texas. Electronic address: dewconsulting@dewconsultingllc.onmicrosoft.com.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2020.08.001']
2228,32952034,Pareidolia in Radiology Education: A Randomized Controlled Trial of Metaphoric Signs in Medical Student Teaching.,"OBJECTIVE


A radiology sign that references a resemblance to something which is not actually present within an image has been termed a 'metaphoric' sign. Metaphoric signs are widely described in the literature and commonly used in teaching as a form of pattern recognition, or 'pareidolia'. However, the educational benefit of metaphoric signs has not been previously assessed. We aimed to assess the utility of metaphoric signs in medical student teaching.
MATERIALS AND METHODS


Fifteen radiology cases were prepared into two lecture formats for medical student education. A 'test' lecture utilizing metaphoric radiology signs to describe the appearance of the cases and a 'control' lecture where pathology was compared to normal anatomical appearances without reference to metaphoric signs. Forty-nine volunteer medical students were randomized with cluster sampling to receive either the test or control lecture. Four days later, students were quizzed to determine retention of knowledge and to assess interest in the lecture on a visual analogue scale from 0 to 100.
RESULTS


The median interest level of the test group (69.5) was higher than the control group (50) (p = 0.001). The mean quiz score was higher in the test group (34.5) than in the control group (29) (Difference 5.5, 95% confidence interval 0.08-10.92, p = 0.047).
CONCLUSION


The use of metaphoric signs in radiology education of medical students increased interest, descriptive ability and short-term knowledge retention, compared to the same material taught with normal anatomy correlation. Metaphoric signs should be considered as a useful radiology teaching tool.",2020,"The use of metaphoric signs in radiology education of medical students increased interest, descriptive ability and short-term knowledge retention, compared to the same material taught with normal anatomy correlation.","['Medical Student Teaching', 'Forty-nine volunteer medical students', 'Fifteen radiology cases', 'Pareidolia in Radiology Education']",[],"['mean quiz score', 'median interest level']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0340868,"The use of metaphoric signs in radiology education of medical students increased interest, descriptive ability and short-term knowledge retention, compared to the same material taught with normal anatomy correlation.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Gibney', 'Affiliation': 'Department of Radiology, Mater Misericordiae University Hospital, Dublin, Ireland; Department of Radiology, Vancouver General Hospital, 899 West 10th Ave, Vancouver, British Columbia, Canada, V5Z 1M9. Electronic address: bgibney1@gmail.com.'}, {'ForeName': 'Ghadir H', 'Initials': 'GH', 'LastName': 'Kassab', 'Affiliation': 'Department of Radiology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Ciaran E', 'Initials': 'CE', 'LastName': 'Redmond', 'Affiliation': 'Department of Radiology, Vancouver General Hospital, 899 West 10th Ave, Vancouver, British Columbia, Canada, V5Z 1M9.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Buckley', 'Affiliation': 'Department of Radiology, Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'MacMahon', 'Affiliation': 'Department of Radiology, Mater Misericordiae University Hospital, Dublin, Ireland; School of Medicine, University College Dublin, Dublin, Ireland. Electronic address: https://twitter.com/BrianTGibney.'}]",Academic radiology,['10.1016/j.acra.2020.08.017']
2229,32948867,"Effects of whey protein and dietary fiber intake on insulin sensitivity, body composition, energy expenditure, blood pressure, and appetite in subjects with abdominal obesity.","BACKGROUND


Recently, we demonstrated that whey protein (WP) combined with low dietary fiber improved lipemia, a risk factor for cardiovascular disease in subjects with abdominal obesity. In the present study, we investigated the effects of intake of WP and dietary fiber from enzyme-treated wheat bran on other metabolic parameters of the metabolic syndrome.
METHODS


The study was a 12-week, double-blind, randomized, controlled, parallel intervention study. We randomized 73 subjects with abdominal obesity to 1 of 4 iso-energetic dietary interventions: 60 g per day of either WP hydrolysate or maltodextrin (MD) combined with high-fiber (HiFi; 30 g dietary fiber/day) or low-fiber (LoFi; 10 g dietary fiber/day) cereal products. We assessed changes in insulin sensitivity, gut hormones (GLP-1, GLP-2, GIP, and peptide YY), body composition, 24-h BP, resting energy expenditure and respiratory exchange ratio (RER), and appetite.
RESULTS


Sixty-five subjects completed the trial. Subjective hunger ratings were lower after 12 weeks of WP compared with MD, independent of fiber content (P = 0.02). We found no effects on ratings of satiety, fullness or prospective food consumption for either of the interventions. Intake of WP combined with LoFi increased the postprandial peptide YY response. There were no effects of WP or fiber on insulin sensitivity, body composition, energy expenditure, incretins, or 24-h BP.
CONCLUSIONS


WP consumption for 12 weeks reduced subjective ratings of hunger in subjects with abdominal obesity. Neither WP nor dietary fiber from wheat bran affected insulin sensitivity, 24-h BP, gut hormone responses, body composition, or energy expenditure compared with MD and low dietary fiber.",2020,"Subjective hunger ratings were lower after 12 weeks of WP compared with MD, independent of fiber content (P = 0.02).","['subjects with abdominal obesity', 'Sixty-five subjects completed the trial', '73 subjects with abdominal obesity to 1 of 4 iso-energetic dietary interventions']","['WP consumption', 'whey protein (WP) combined with low dietary fiber improved lipemia', 'WP combined with LoFi', 'WP hydrolysate or maltodextrin (MD) combined with high-fiber (HiFi; 30\u2009g dietary fiber/day) or low-fiber (LoFi; 10\u2009g dietary fiber/day) cereal products', 'whey protein and dietary fiber intake', 'WP and dietary fiber from enzyme-treated wheat bran']","['WP or fiber on insulin sensitivity, body composition, energy expenditure, incretins, or 24-h BP', 'postprandial peptide YY response', 'insulin sensitivity, 24-h BP, gut hormone responses, body composition, or energy expenditure', 'insulin sensitivity, gut hormones (GLP-1, GLP-2, GIP, and peptide YY), body composition, 24-h BP, resting energy expenditure and respiratory exchange ratio (RER), and appetite', 'insulin sensitivity, body composition, energy expenditure, blood pressure, and appetite', 'subjective ratings of hunger', 'ratings of satiety, fullness or prospective food consumption', 'Subjective hunger ratings']","[{'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0474451', 'cui_str': 'Dietary fiber intake'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043138', 'cui_str': 'Wheat bran'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0912332', 'cui_str': 'Glucagon-like peptide 2'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",73.0,0.0563907,"Subjective hunger ratings were lower after 12 weeks of WP compared with MD, independent of fiber content (P = 0.02).","[{'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Fuglsang-Nielsen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark. rasmusfuglsang@gmail.com.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Rakvaag', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Knud Erik Bach', 'Initials': 'KEB', 'LastName': 'Knudsen', 'Affiliation': 'Department of Animal Science, Aarhus University, Tjele, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Gregersen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",European journal of clinical nutrition,['10.1038/s41430-020-00759-4']
2230,32947994,A Pilot Evaluation of a Smartphone Application for Workplace Depression.,"Interventions delivered via mobile apps show particular promise in tackling the burden of common mental disorders. Appropriately targeting these interventions to at-risk populations is critical to their success. This pilot study aimed to assess the usability, feasibility, acceptability, and preliminary effects of an app-based intervention designed to target depressive symptoms in a stressed working population. Anchored, a smartphone app including a 30-day program of mindfulness and cognitive and behavioural therapeutic components, was tested in a pre-post pilot study with participants recruited via social media advertisements. Eligible participants (N = 81) were Australian adults who were employed and reported elevated stress levels on a single-item screening measure. Follow-up assessment occurred 5 weeks after baseline. The primary outcome measure was change in depressive symptoms, with secondary outcomes measuring change in anxiety, wellbeing, stress, resilience, exercise, alcohol use, absenteeism, and work performance. User feedback and in-app data were analysed to assess engagement and intervention adherence. At follow-up, there were significant reductions in depressive symptoms (t 61  = 6.35;  p  < 0.001) and anxiety symptoms (t 60  = 7.35;  p  < 0.001), along with significantly reduced cases of likely new onset depression compared to baseline (24% vs. 6%,  p =  0.012). Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001). Participants reported no significant changes in work performance, absenteeism or exercise. There were satisfactory levels of app usability, feasibility, and acceptability. Most participants found the app easy to use (93.2%), understood the app content well (83.0%), and rated the app highly or very highly overall (72.9%). User feedback suggestions were predominantly focused on improving app navigation and user interface. This pilot study provides encouraging evidence that Anchored has potentially beneficial effects, and is usable, feasible, and acceptable as an app-based intervention for the working population experiencing elevated stress. Further testing of Anchored in a randomised controlled trial is required to investigate its efficacy as an intervention for workplace mental ill-health.",2020,"Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001).","['Eligible participants (N = 81) were Australian adults who were employed and reported elevated stress levels on a single-item screening measure', 'stressed working population', 'participants recruited via social media advertisements', 'Workplace Depression', 'workplace mental ill-health']",['Smartphone Application'],"['wellbeing', 'usability, feasibility, acceptability', 'anxiety symptoms', 'change in depressive symptoms, with secondary outcomes measuring change in anxiety, wellbeing, stress, resilience, exercise, alcohol use, absenteeism, and work performance', 'satisfactory levels of app usability, feasibility, and acceptability', 'work performance, absenteeism or exercise', 'depressive symptoms', 'new onset depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",81.0,0.281056,"Significant improvements were also seen in wellbeing (t 60  = -5.64;  p  < 0.001), resilience (t 60  = -3.89;  p  < 0.001), stress (t 61  = 11.18;  p  < 0.001), and alcohol use (t 60  = 3.40;  p  = 0.001).","[{'ForeName': 'Daniel A J', 'Initials': 'DAJ', 'LastName': 'Collins', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Harvey', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Lavender', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': 'Brain and Mind Centre, Central Clinical School, Faculty of Medicine and Health, University of Sydney,Sydney, NSW 2050, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Deady', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186753']
2231,32948045,Comparison of the Effects of Visual and Auditory Distractions on Fistula Cannulation Pain among Older Patients Undergoing Hemodialysis: A Randomized Controlled Clinical Trial.,"Pain associated with fistula cannulation is a challenge for nurses who provide care to older patients undergoing hemodialysis. Several non-pharmacological methods have been suggested for relieving fistula cannulation pain, but the benefits of visual and auditory distraction methods among older patients undergoing hemodialysis have not been investigated yet. Therefore, this study aimed to compare the effects of visual and auditory distractions on fistula cannulation pain among older patients undergoing hemodialysis. This randomized controlled clinical trial was conducted on 120 older patients undergoing hemodialysis. They were randomly assigned to three groups of visual distraction, auditory distraction, and the control ( n  = 40 in each group) using a simple random assignment method. The distraction interventions continued for three consecutive sessions and the numeric rating scale of pain severity was used for data collection. Descriptive and inferential statistics were used for data analysis using SPSS. It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001). However, visual distraction had a better effect on the reduction of pain severity. Therefore, while both visual and auditory distractions reduced pain severity in older patients undergoing hemodialysis, visual distraction was more effective. Nurses are encouraged to incorporate visual distraction as a safe and non-pharmacologic technique into routine nursing care for reducing older patients' suffering and improving their wellbeing when fistula cannulation is performed.",2020,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001).,"['Older Patients Undergoing Hemodialysis', 'older patients undergoing hemodialysis', 'older patients undergoing', '120 older patients undergoing hemodialysis']","['Visual and Auditory Distractions', 'hemodialysis, visual distraction', 'fistula cannulation', 'visual and auditory distractions', 'visual distraction, auditory distraction, and the control']","['fistula cannulation pain', 'Fistula Cannulation Pain', 'Pain', 'numeric rating scale of pain severity', 'pain severity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",120.0,0.0398348,It was found that pain severity significantly reduced after the distraction interventions in either the auditory or visual distraction groups and also after all three distraction sessions ( p  = 0.001).,"[{'ForeName': 'Mina Ghadimi', 'Initials': 'MG', 'LastName': 'Aghbolagh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Bahrami', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Rejeh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Majideh', 'Initials': 'M', 'LastName': 'Heravi-Karimooi', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran 3319118651, Iran.'}, {'ForeName': 'Seyed Davood', 'Initials': 'SD', 'LastName': 'Tadrisi', 'Affiliation': 'Trauma Research Center, Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran 1435916471, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway.'}]","Geriatrics (Basel, Switzerland)",['10.3390/geriatrics5030053']
2232,32949918,A high-protein meal does not improve blood pressure or vasoactive biomarker responses to acute exercise in humans.,"Blood pressure (BP) responses to exercise yield prognostic information beyond resting BP. While habitual higher dietary protein intake is associated with reduced resting BP, few studies have assessed the impact of high-protein meals on acute BP and vasoactive biomarker responses to exercise. To test the hypothesis that consuming a higher-protein, lower fat meal (HP; 30 g protein, 17 g fat, 52 g carbohydrate) would attenuate the BP response to exercise and result in a more robust post-exercise hypotensive response compared to a lower-protein, higher-fat meal (LP; 13 g protein, 25 g fat, 54 g carbohydrate), we recruited 31 pre-hypertensive subjects to complete this randomized, double-blind, cross-over acute feeding study. One hundred sixty-five minutes after consuming the test HP or LP meal, subjects exercised on a cycle ergometer at 70% VO 2  max for 30 minutes. Blood pressure was measured prior to the meal and periodically before, during, and after exercise for a 315-minute period. Blood samples were periodically collected to quantify plasma arginine, arginine metabolites (asymmetric dimethylarginine, symmetric dimethylarginine; ADMA, SDMA), endothelin-1, nitrates, and nitrites in a subset of subjects (n = 15) as shown in Supplemental Table S1. Consuming the HP meal did not influence the BP responses to exercise, including the post-exercise return to baseline BP or systolic BP area under the curve. While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered. These results suggest that consuming a higher-protein, lower-fat meal does not influence BP or vasoactive biomarker responses to exercise compared to a lower-protein, higher-fat meal.",2020,"While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered.","['humans', '31 pre-hypertensive subjects']","['carbohydrate', 'HP meal']","['postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites', 'plasma arginine, arginine metabolites (asymmetric dimethylarginine, symmetric dimethylarginine; ADMA, SDMA), endothelin-1, nitrates, and nitrites', 'BP responses', 'post-exercise return to baseline BP or systolic BP area under the curve', 'blood pressure or vasoactive biomarker responses', 'Blood pressure', 'BP response', 'Blood pressure (BP) responses']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0067305', 'cui_str': ""N,N'-dimethylarginine""}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.037945,"While the HP meal resulted in greater postprandial plasma arginine concentrations, ADMA, SDMA, endothelin-1, nitrates, and nitrites were unaltered.","[{'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Bergia', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State St, West Lafayette, IN 47907.'}, {'ForeName': 'Wayne W', 'Initials': 'WW', 'LastName': 'Campbell', 'Affiliation': 'Department of Nutrition Science, Purdue University, 700 West State St, West Lafayette, IN 47907. Electronic address: campbellw@purdue.edu.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Roseguini', 'Affiliation': 'Department of Health & Kinesiology, Purdue University, 800 W Stadium Ave, West Lafayette, IN 47907.'}, {'ForeName': 'Jung Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Food Science and Technology Programme, c/o Department of Chemistry, National University of Singapore, 3 Science Drive 3, Singapore 117543. Electronic address: chmkje@nus.edu.sg.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.001']
2233,32949941,Exploring the use of Immersive Virtual Reality to enhance Psychological Well-Being in Pediatric Oncology: A pilot randomized controlled trial.,"PURPOSE


To investigate whether Immersive Virtual Reality (VR) has a greater positive influence on oncology patients' physical and emotional mood states when compared to an iPad attentional control condition. Our secondary objective was to understand what factors influenced VR effectiveness.
METHOD


Participants were 90 oncology inpatients, aged 7-19 years, and their primary parent caregiver. Using a randomized controlled study design patients were allocated to VR (three content groups) or an iPad control condition. Pre-post-intervention self-report state measures were collected using visual analogue scales and an objective measure of physiological arousal (pulse rate). Post-intervention, patients reported on level of immersion, enjoyment and simulator sickness.
RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes. However, patients accessing Immersive VR consistently reported greater positive shifts in mood state and reductions in negative symptoms when compared with iPad. No change was observed in physiological arousal levels (pulse rate) in either condition before, during or immediately after intervention. Moderation analysis showed that the degree of child illness (PedsQL), sex, age, and level of immersion were important in influencing the magnitude of differences between the VR and iPad conditions on mood, anxiety and pain.
CONCLUSIONS


These preliminary findings support the use of Immersive VR in clinical oncology settings to improve patient well-being. Further studies examining the application of Immersive VR in supporting children adjusting to hospitalization and cancer treatment are therefore warranted. Factors found to moderate VR effectiveness provide important clinical implications.",2020,"RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes.","['Participants were 90 oncology inpatients, aged 7-19 years, and their primary parent caregiver', 'Pediatric Oncology']","['Immersive VR', 'Immersive Virtual Reality', 'Immersive Virtual Reality (VR', 'iPad control condition']","['physiological arousal levels (pulse rate', 'physiological arousal (pulse rate', 'mood, anxiety and pain', 'level of immersion, enjoyment and simulator sickness', 'VR effectiveness', 'degree of child illness (PedsQL), sex, age, and level of immersion', 'negative symptoms']","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",90.0,0.0255989,"RESULTS


Patients benefited from both Immersive VR and novel iPad intervention with no statistically significant differences found between conditions on child outcomes.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Tennant', 'Affiliation': ""School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia; Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia. Electronic address: michelle.tennant@mcri.edu.au.""}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Youssef', 'Affiliation': ""School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Centre for Adolescent Health, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McGillivray', 'Affiliation': 'School of Psychology, Faculty of Health, Deakin University, Geelong, Victoria, 3220, Australia; Deakin Child Study Centre, School of Psychology, Deakin University, Burwood, Victoria, 3125, Australia.'}, {'ForeName': 'Tara-Jane', 'Initials': 'TJ', 'LastName': 'Clark', 'Affiliation': ""Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McMillan', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia.""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'McCarthy', 'Affiliation': ""Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, 3052, Australia; Children's Cancer Centre, The Royal Children's Hospital, Parkville, Victoria, 3052, Australia; Department of Paediatrics, University of Melbourne, Parkville, Victoria, 3052, Australia.""}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101804']
2234,32949991,Motor imagery combined with action observation training optimized for individual motor skills further improves motor skills close to a plateau.,"The acquisition of high-level motor skills beyond a ""plateau"" is important in sports training and rehabilitation. We aimed to investigate whether motor skills close to a plateau state can be improved further by performing motor imagery (MI) training while observing movements with difficulty levels optimized for individual motor skills. The subjects were divided randomly into four groups (n = 10 per group): the control group and three groups of MI combined with action observation (MI + AO) training with varying difficulty levels. The task was to rotate the two cork balls 20 times counterclockwise using the left hand. The subjects performed 30 and 10 successful trials of this task before and after MI + AO training, respectively. In the three training groups, MI training was performed while observing videos showing ball rotation movements adjusted to the same level, a moderately higher level, or a remarkably higher level of difficulty than that achieved by the individual subjects. The improvement rate of the ball rotation time after MI + AO training was significantly higher in the moderate-difficulty than in the control group and remarkably higher level of difficulty group. The other two MI + AO training groups did not differ significantly compared with the control group. The vividness of the MI during MI + AO training was significantly greater in the moderate-difficulty vs. the remarkably-high-difficulty group. These results suggest that performing MI training while observing movement at a level that is moderately higher than an individual's ability can promote improvements in motor skills (close to a plateau state) in rehabilitation and sports training. The vividness of MI may be an important index for determining the difficulty level of the movement to be observed during MI + AO training.",2020,The vividness of the MI during MI + AO training was significantly greater in the moderate-difficulty vs. the remarkably-high-difficulty group.,[],"['MI training', 'MI combined with action observation (MI\xa0+\xa0AO) training with varying difficulty levels', 'Motor imagery combined with action observation training', 'motor imagery (MI) training']","['motor skills', 'vividness of the MI during MI\xa0+\xa0AO training', 'motor skills close', 'improvement rate of the ball rotation time after MI\xa0+\xa0AO training']",[],"[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0112839,The vividness of the MI during MI + AO training was significantly greater in the moderate-difficulty vs. the remarkably-high-difficulty group.,"[{'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Aoyama', 'Affiliation': 'Department of Physical Therapy, Ibaraki Prefectural University of Health Sciences, 4669-2 Ami, Ami-Machi, Inashiki-gun, Ibaraki, Japan. Electronic address: aoyamato@ipu.ac.jp.'}, {'ForeName': 'Fuminari', 'Initials': 'F', 'LastName': 'Kaneko', 'Affiliation': 'Department of Rehabilitation Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan. Electronic address: f-kaneko@keio.jp.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kohno', 'Affiliation': 'Centre for Medical Sciences, Ibaraki Prefectural University of Health Sciences, 4669-2 Ami, Ami-Machi, Inashiki-gun, Ibaraki, Japan. Electronic address: kohno@ipu.ac.jp.'}]",Human movement science,['10.1016/j.humov.2020.102683']
2235,32952701,Predicting Equations and Resting Energy Expenditure Changes in Overweight Adults.,"Introduction


The aim of the study is to show the differences between the measured and estimated values of resting energy expenditure and any changes occurring after the 6-month weight loss intervention program.
Methods


We included 33 healthy adults aged 25-49 years with an average body mass index 29.1±2.7 kg/m 2 for female and 29.8±2.8 kg/m 2  for male. The measured resting energy expenditure was obtained by indirect calorimeter MedGem® Microlife and estimated resting energy expenditure by the Harris-Benedict equation, the Mifflin-St Jeor equation, the Owen equation, the Wright equation, and by the Tanita body composition analyser. All measurements and calculations were carried out before and after the 6-month intervention. Results were compared using paired t-tests. P value less than 0.05 was considered statistically significant.
Results


A comparison of the measured resting energy expenditure of female subjects with the estimated resting energy expenditure using the Harris-Benedict equation, the Mifflin-St Jeor equation and the Wright equation showed a statistically significant difference. A comparison of the measured resting energy expenditure of male subjects with the estimated resting energy expenditure using the Harris-Benedict equation and the Wright equation showed a statistically significant difference. There was a significant difference in the measured resting energy expenditure and estimated resting energy expenditure using Tanita.
Conclusions


We concluded that the most comparable equation for our sample was the Owen's equation. After losing weight, the measured resting energy expenditure has decreased, which must be taken into account in further diet therapy.",2020,"There was a significant difference in the measured resting energy expenditure and estimated resting energy expenditure using Tanita.
","['female subjects', 'male subjects', 'Overweight Adults', '33 healthy adults aged 25-49 years with an average body mass index 29.1±2.7 kg/m 2 for female and 29.8±2.8 kg/m 2  for male']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",[],[],33.0,0.0287289,"There was a significant difference in the measured resting energy expenditure and estimated resting energy expenditure using Tanita.
","[{'ForeName': 'Mojca', 'Initials': 'M', 'LastName': 'Stubelj', 'Affiliation': 'University of Primorska, Faculty of Health Sciences, Polje 42, 6310 Izola, Slovenia.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Teraž', 'Affiliation': 'Science and Research Centre Koper, Institute for Kinesiology Research, Garibaldijeva 1, 6000 Koper, Slovenia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Poklar Vatovec', 'Affiliation': 'University of Primorska, Faculty of Health Sciences, Polje 42, 6310 Izola, Slovenia.'}]",Zdravstveno varstvo,['10.2478/sjph-2020-0005']
2236,32952713,Optimisation of Heart Failure Management in Nursing Homes Using Point-of-Care Ultrasonography: Harmonious Trial Rationale and Design.,"Introduction


Heart failure is common in the nursing home population and presents many diagnostic and therapeutic challenges. Point-of-care ultrasonography is a bedside method that can be used to assess volume status more reliably than clinical examination. This trial was conceived to test whether point-of-care ultrasonography-guided management improves heart failure outcomes among nursing home residents.
Methods


Nursing home residents with heart failure will be enrolled in a multi-centre, prospective, randomised controlled trial. Residents will first be screened for heart failure. Patients with heart failure will be randomised in 1:1 fashion into two groups. Nursing home physicians will adjust diuretic therapy according to volume status for six months. Point-of-care ultrasonography will be used in the test group and clinical examination in the control group. The primary endpoint will be heart failure deterioration, defined as a composite of any of the following four events: the need for an intravenous diuretic application, the need for an emergency service intervention, the need for unplanned hospitalisation for non-injury causes, or death from whatever cause.
Expected results


The expected prevalence of heart failure among nursing home residents is above 10%. Point-of-care ultrasonography-guided heart failure management will reduce the number of deteriorations of heart failure in the nursing home population.
Conclusion


This study will explore the usefulness of point-of-care ultrasonography for heart failure management in the nursing home population.",2020,"This trial was conceived to test whether point-of-care ultrasonography-guided management improves heart failure outcomes among nursing home residents.
","['Methods\n\n\nNursing home residents with heart failure', 'Patients with heart failure', 'nursing home residents']","['care ultrasonography-guided management', 'point-of-care ultrasonography']","['heart failure outcomes', 'heart failure', 'heart failure deterioration, defined as a composite of any of the following four events: the need for an intravenous diuretic application, the need for an emergency service intervention, the need for unplanned hospitalisation for non-injury causes, or death from whatever cause']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0494474,"This trial was conceived to test whether point-of-care ultrasonography-guided management improves heart failure outcomes among nursing home residents.
","[{'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Homar', 'Affiliation': 'University of Ljubljana, Faculty of Medicine, Department of Family Medicine, Poljanski nasip 58, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Švab', 'Affiliation': 'University of Ljubljana, Faculty of Medicine, Department of Family Medicine, Poljanski nasip 58, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Mitja', 'Initials': 'M', 'LastName': 'Lainščak', 'Affiliation': 'University of Ljubljana, Faculty of Medicine, Vrazov trg 2, 1000 Ljubljana, Slovenia.'}]",Zdravstveno varstvo,['10.2478/sjph-2020-0017']
2237,32952830,Randomized controlled trial comparing 400μg sublingual misoprostol versus placebo for prevention of primary postpartum hemorrhage.,"Introduction


obstetric hemorrhage is estimated to cause 25% of all maternal deaths and is the leading direct cause of maternal mortality worldwide. The World Health Organization recommended the use of uterotonics that should be offered for all women who will give birth but in some countries or in special situations oxytocin is not available. The goal of this study is to determine whether the 400μg dose of Misoprostol decreases the incidence of postpartum hemorrhage (PPH) of women who did not show signs of hemorrhage.
Methods


a prospective randomized double blind controlled trial was conducted between February 2012 and June 2012, among women in the active stage of labor attending the Obstetric Gynecology Department, University Hospital Farhat Hached of Sousse, Tunisia. Women with term singleton pregnancies greater than 32 weeks of amenorrhea with anticipated vaginal delivery were eligible for the study. Participants were randomly assigned to receive 400 μg sublingual Misoprostol or 2 ets of placebo immediately after cord clamping. The primary outcome measures were an estimation of blood loss including the subjective finding of vaginal hemorrhage > 500 ml, the decrease of hemoglobin and hematocrit, a change in hemodynamic parameters, and the need for additional dose of oxytocin. Secondary outcomes were occurrence of possible side effects such as: headache, nausea, vomiting, pyrexia, diarrhea and abdominal pain.
Results


a total of 211 patients were randomized: 111 in the Misoprostol group (Cytotec*) and 100 patients in the placebo group. The two groups were similar in terms of sociodemographic characteristics. Significant difference between the 400-μg of Misoprostol and placebo group were recorded in mean postpartum blood and PPH occurrence. The difference in pre- and postpartum hemoglobin loss (expressed in grams per 100 ml) was 1.21 ± 1.05 for the Misoprostol group and 1.51 ± 0.74 for the placebo group with significant difference (p = 0.02). No differences were observed in the occurrence of headache, dizziness, vomiting, diarrhea and metallic taste but the incidence of shivering was more than twice as great among women receiving Misoprostol than among those treated with placebo with a significant difference (p = 0.01). Similarly, women who received Misoprostol had a significantly higher mean temperature after delivery in comparison with those receiving placebo.
Conclusion


misoprostol, administered as 400 μg after delivery, appears to be effective for the prevention of post-partum hemorrhage, but its side effects appears to be significant.",2020,"No differences were observed in the occurrence of headache, dizziness, vomiting, diarrhea and metallic taste but the incidence of shivering was more than twice as great among women receiving Misoprostol than among those treated with placebo with a significant difference (p = 0.01).","['February 2012 and June 2012, among women in the active stage of labor attending the Obstetric Gynecology Department, University Hospital Farhat Hached of Sousse, Tunisia', 'Women with term singleton pregnancies greater than 32 weeks of amenorrhea with anticipated vaginal delivery were eligible for the study', 'women who did not show signs of hemorrhage', 'primary postpartum hemorrhage', '211 patients were randomized: 111 in the']","['Misoprostol', 'misoprostol', '400μg sublingual misoprostol', '400 μg sublingual Misoprostol', 'placebo']","['incidence of postpartum hemorrhage (PPH', 'estimation of blood loss including the subjective finding of vaginal hemorrhage > 500 ml, the decrease of hemoglobin and hematocrit, a change in hemodynamic parameters, and the need for additional dose of oxytocin', 'occurrence of headache, dizziness, vomiting, diarrhea and metallic taste but the incidence of shivering', 'occurrence of possible side effects such as: headache, nausea, vomiting, pyrexia, diarrhea and abdominal pain', 'pre- and postpartum hemoglobin loss', 'mean temperature', 'mean postpartum blood and PPH occurrence']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041388', 'cui_str': 'Tunisia'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0269899', 'cui_str': 'Atonic postpartum hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0303403', 'cui_str': 'Indium-111'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0240327', 'cui_str': 'Metallic taste'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",211.0,0.748113,"No differences were observed in the occurrence of headache, dizziness, vomiting, diarrhea and metallic taste but the incidence of shivering was more than twice as great among women receiving Misoprostol than among those treated with placebo with a significant difference (p = 0.01).","[{'ForeName': 'Rym', 'Initials': 'R', 'LastName': 'Zgaya', 'Affiliation': 'Department of Gynecology and Obstetrics, Farhat Hached University Hospital, Sousse, Tunisia.'}, {'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Ghadhab', 'Affiliation': 'Department of Gynecology and Obstetrics, Farhat Hached University Hospital, Sousse, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Triki', 'Affiliation': 'Faculty of Medicine, Sousse, Tunisia.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Briki', 'Affiliation': 'Department of Gynecology and Obstetrics, Farhat Hached University Hospital, Sousse, Tunisia.'}]",The Pan African medical journal,['10.11604/pamj.2020.36.186.22538']
2238,32952888,Acemannan induces rapid early osseous defect healing after apical surgery: A 12-month follow-up of a randomized controlled trial.,"Background/purpose


Acemannan is an osteoinductive material. This study's objective was to compare the outcomes of bone defect healing using 3-dimensional images after apical surgery with or without adding acemannan sponges.
Materials and methods


Twenty-two anterior teeth from 9 males and 13 females requiring apical surgery were included in this randomized controlled trial. Post-surgery, the bone defects were randomly divided into three groups: blood clot control, 5-, or 10-mg acemannan sponge groups. CBCT scans were taken immediately (baseline), 3-, 6-, and 12-month post-surgery. Sagittal serial sections (1 mm thick slices parallel to the long axis of the tooth) of the defect image were created. The defect boundary was located and the total bone defect volume (BDV) was calculated from the sum of the volume of the serial defect sections. The bone healing was assessed by the percentage of total bone defect volume reduction (%ΔBDV). The paired t-test and one-way ANOVA were used to analyze the differences within each group and between groups, respectively.
Results


The baseline mean BDV of the control, 5-, and 10-mg acemannan groups were not significantly different ( p  > 0.05). After treatment, the mean BDV for each group was reduced in a time-dependent manner. Compared with the control group, the 5- and 10-mg acemannan groups had a significantly greater %ΔBDV (approximately 2- and 1.89-fold) at 3-months post-surgery, respectively ( p  < 0.05). However, at the 6- and 12- month follow-up, the %ΔBDV was not significantly different between the groups.
Conclusion


These data suggest acemannan enhanced early bone healing after apical surgery.",2020,"However, at the 6- and 12- month follow-up, the %ΔBDV was not significantly different between the groups.
","['Materials and methods\n\n\nTwenty-two anterior teeth from 9 males and 13 females requiring apical surgery', 'apical surgery']","['acemannan', '3-dimensional images after apical surgery with or without adding acemannan sponges', 'Acemannan', 'blood clot control, 5-, or 10-mg acemannan sponge groups']","['bone healing', 'mean BDV', 'baseline mean BDV', 'total bone defect volume (BDV', 'ΔBDV']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0050408', 'cui_str': 'acemannan'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0001762', 'cui_str': 'Afterimage'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",22.0,0.0437338,"However, at the 6- and 12- month follow-up, the %ΔBDV was not significantly different between the groups.
","[{'ForeName': 'Cuong', 'Initials': 'C', 'LastName': 'Le Van', 'Affiliation': 'Dental Biomaterials Science Program, Graduate School, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Hien Pham', 'Initials': 'HP', 'LastName': 'Thi Thu', 'Affiliation': 'Department of Endodontics, National Hospital of Odonto-Stomatology, Hanoi, Viet Nam.'}, {'ForeName': 'Polkit', 'Initials': 'P', 'LastName': 'Sangvanich', 'Affiliation': 'Department of Chemistry, Faculty of Science, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Vannaporn', 'Initials': 'V', 'LastName': 'Chuenchompoonut', 'Affiliation': 'Department of Radiology, Faculty of Dentistry, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pasutha', 'Initials': 'P', 'LastName': 'Thunyakitpisal', 'Affiliation': 'Research Unit of Herbal Medicine, Biomaterial, and Material for Dental Treatment, Department of Anatomy, Faculty of Dentistry, Chulalongkorn University, Henri-Dunant Rd, Patumwan, Bangkok, 10330, Thailand.'}]",Journal of dental sciences,['10.1016/j.jds.2019.09.012']
2239,32953086,Evaluation and pilot implementation of essential interventions for the management of hypertension and prevention of cardiovascular diseases in primary health care in the Republic of Tajikistan.,"Background:  Non-communicable diseases (NCDs) are the leading cause of death worldwide and are a major burden in Tajikistan. The health system of Tajikistan is still shaped by the country's Soviet legacy and the pace of reform has been slow, with high patient out-of-pocket expenditure. The aim of this study is to determine the feasibility of implementing and evaluating essential interventions for the management of hypertension and prevention of cardiovascular disease in primary health care in Tajikistan.  Methods and analysis:  A pragmatic, sequential mixed methods explanatory design, composed of quantitative and qualitative strands will be used with greater weighting of the quantitative strand. A single geographic district was nominated by the Ministry of Health and chosen for implementation. All primary health care centres in the district that meet inclusion criteria will be included; half will be randomly assigned to the intervention arm and half to the control arm. The overall process is organized into seven steps: (1) refresh clinical decision-making tools including open source WHO PEN and HEARTS resources; (2) update training package for primary health care workers; (3) collection of baseline data; (4) training staff in intervention clinics; (5) implementation of protocols and implementation coaching; (6) collection of follow-up data after 12 months; (7) evaluation of results and sharing experience.  Ethics and dissemination:  Ethical review and approval have been obtained. Findings will be disseminated at the participant level, national level through a national conference of key stakeholders, and internationally through publication in an open-access peer review journal.",2019,"The health system of Tajikistan is still shaped by the country's Soviet legacy and the pace of reform has been slow, with high patient out-of-pocket expenditure.","['All primary health care centres in the district that meet inclusion criteria will be included; half', 'primary health care in Tajikistan', 'primary health care in the Republic of Tajikistan']",['essential interventions'],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039247', 'cui_str': 'Tajikistan'}]","[{'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0401091,"The health system of Tajikistan is still shaped by the country's Soviet legacy and the pace of reform has been slow, with high patient out-of-pocket expenditure.","[{'ForeName': 'Dylan R J', 'Initials': 'DRJ', 'LastName': 'Collins', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Laatikainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Helsinki, Finland.'}, {'ForeName': 'Mekhri', 'Initials': 'M', 'LastName': 'Shoismatuloeva', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Isfandiyor', 'Initials': 'I', 'LastName': 'Mahmudzoha', 'Affiliation': 'Ministry of Health and Social Protection, Dushanbe, Tajikistan.'}, {'ForeName': 'Zakriya', 'Initials': 'Z', 'LastName': 'Rahimov', 'Affiliation': 'Ministry of Health and Social Protection, Dushanbe, Tajikistan.'}, {'ForeName': 'Dilorom', 'Initials': 'D', 'LastName': 'Sultonova', 'Affiliation': 'Service of State Supervision for Medical Activities and Social Protection of the Population of the Republic of Tajikistan, Dushanbe, Tajikistan.'}, {'ForeName': 'Bunafsha', 'Initials': 'B', 'LastName': 'Jonova', 'Affiliation': 'Republican Clinical and Training Centre of Family Medicine, Dushanbe, Tajikistan.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Farrington', 'Affiliation': 'World Health Organization Regional Office for Europe, Copenhagen, Denmark.'}]",F1000Research,['10.12688/f1000research.20234.1']
2240,32953097,"Comment on ""Comparing open conventional carpal tunnel release with mini-incision technique in the treatment of carpal tunnel syndrome - a non-randomized clinical trial"".",,2020,,[],['Comparing open conventional carpal tunnel release with mini-incision technique'],[],[],"[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0196576', 'cui_str': 'Decompression of median nerve'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],,0.0155988,,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Haiser', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Chloe L', 'Initials': 'CL', 'LastName': 'Jordan', 'Affiliation': 'Imperial College School of Medicine, Imperial College London, London, United Kingdom.'}]",Annals of medicine and surgery (2012),['10.1016/j.amsu.2020.07.048']
2241,32953142,Local Usage of  Nigella sativa  Oil as an Innovative Method to Attenuate Primary Dysmenorrhea: A Randomized Double-blind Clinical Trial.,"Objectives


We sought to determine the effect of topical application of  Nigella sativa  (black seed) oil, on the primary dysmenorrhea intensity.
Methods


We conducted a randomized, double-blind clinical trial on 124 female students, 18-22 years old, living in the dormitories of Sabzevar Universities. After a primary assessment, participants were randomly divided into two groups. The first group rubbed two drops of  N. sativa  oil, and the second group rubbed liquid olive oil, as the placebo. Massage was performed on the fontanel lobe 3, at night, three days before menstruation, for eight consecutive days (about five days after menses). This procedure was repeated for three menstrual cycles. After three cycles, pain severity was measured by the visual analog scale. Data analysis was carried out using the Mann-Whitney U test and analysis of covariance (ANCOVA).
Results


This study was conducted on 124 female students. The mean age of students, mean age of first menarche, body mass index, and pain severity were not significantly different in the two groups ( p  > 0.050). No adverse effects were observed during the study. The results of ANCOVA showed that pain intensity in  N. sativa  oil group was significantly decreased compared to that of the placebo group (0.6 score;  p  < 0.050).
Conclusions


N .  sativa  could be a promising, safe, and easily available analgesic supplement in women suffering from primary dysmenorrhea.",2020,"sativa  could be a promising, safe, and easily available analgesic supplement in women suffering from primary dysmenorrhea.","['Primary Dysmenorrhea', '124 female students', 'women suffering from primary dysmenorrhea', '124 female students, 18-22 years old, living in the dormitories of Sabzevar Universities']","['placebo', 'Nigella sativa  (black seed) oil', 'N. sativa  oil, and the second group rubbed liquid olive oil, as the placebo']","['visual analog scale', 'body mass index, and pain severity', 'adverse effects', 'pain intensity', 'pain severity']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",124.0,0.217759,"sativa  could be a promising, safe, and easily available analgesic supplement in women suffering from primary dysmenorrhea.","[{'ForeName': 'Ezat', 'Initials': 'E', 'LastName': 'Samadipour', 'Affiliation': 'Department of Nursing, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Rakhshani', 'Affiliation': 'Department of Statistic, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Kooshki', 'Affiliation': 'Non-Communicable Diseases Research Center, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Amin', 'Affiliation': 'Cellular and Molecular Research Center, Department of Physiology and Pharmacology, Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Oman medical journal,['10.5001/omj.2020.109']
2242,32953174,"Effects of the Intervention ""Reflective STRENGTH-Giving Dialogues"" for Older Adults Living with Long-Term Pain: A Pilot Study.","Background


Long-term musculoskeletal pain is a major, often undertreated, disabling health problem among an increasing number of older adults. Reflective STRENGTH-giving dialogues (STRENGTH) may be a tool to support older adults living with long-term pain. The main aim of this pilot study was to investigate the immediate and longitudinal effect of the intervention STRENGTH on levels of pain, wellbeing, occurrence of depression symptoms, and sense of coherence (SOC) among community-dwelling older adults suffering from musculoskeletal pain compared to a control group.
Methods


The study was semiexperimental with an intervention group and a control group. The effect of a single STRENGTH intervention was reported on the Numeric Rating Scale (NRS) regarding pain and wellbeing. To evaluate the longitudinal effect of STRENGTH, using the Brief Pain Inventory-Short Form (BPI-SF), the Geriatric Depression Scale-20 (GDS-20), SOC-13 at baseline (T1), and six months after the intervention/no intervention (T2), a total of 30 older adults, aged 72 to 97 years (Mdn 86 years), were included consecutively and fulfilled the intervention series ( n  = 18) or untreated controls ( n  = 12).
Results


The intervention with STRENGTH decreases pain (NRS 6 Mdn versus NRS 4 Mdn,  p  < 0.001) and increases wellbeing (NRS 7 Mdn versus NRS 8 Mdn,  p  < 0.001). After a six-month study period with STRENGTH, no longitudinal effect difference was found compared to baseline. Compared to the control group, there was an increasing trend between decreased pain level and increased SOC level for STRENGTH intervention.
Conclusions


This pilot study supports STRENGTH's effect as a pain-alleviating model that provides a decrease in pain levels and an increase of wellbeing in older adults with long-term pain. STRENGTH dialogues could be a useful intervention to provide individually holistic care in older adults living with long-term pain.",2020,"The intervention with STRENGTH decreases pain (NRS 6 Mdn versus NRS 4 Mdn,  p  < 0.001) and increases wellbeing (NRS 7 Mdn versus NRS 8 Mdn,  p  < 0.001).","['older adults living with long-term pain', 'community-dwelling older adults suffering from musculoskeletal pain compared to a control group', 'older adults with long-term pain', 'Older Adults Living with Long-Term Pain', '30 older adults, aged 72 to 97 years (Mdn 86 years), were included consecutively and fulfilled the intervention series ( n \u2009=\u200918) or untreated controls ( n \u2009=\u200912']","['Intervention ""Reflective STRENGTH-Giving Dialogues', 'STRENGTH, using the Brief Pain Inventory-Short Form (BPI-SF']","['Numeric Rating Scale (NRS) regarding pain and wellbeing', 'pain levels', 'levels of pain, wellbeing, occurrence of depression symptoms, and sense of coherence (SOC', 'pain level and increased SOC level', 'pain']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}]",30.0,0.029726,"The intervention with STRENGTH decreases pain (NRS 6 Mdn versus NRS 4 Mdn,  p  < 0.001) and increases wellbeing (NRS 7 Mdn versus NRS 8 Mdn,  p  < 0.001).","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hedén', 'Affiliation': 'Faculty of Caring Science, Work Life and Social Welfare, University of Borås, Borås, Sweden.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Berglund', 'Affiliation': 'School of Health Sciences, University of Skövde, Skövde, Sweden.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Gillsjö', 'Affiliation': 'School of Health Sciences, University of Skövde, Skövde, Sweden.'}]",Journal of aging research,['10.1155/2020/7597524']
2243,32953180,CPR Compression Rotation Every One Minute Versus Two Minutes: A Randomized Cross-Over Manikin Study.,"Background


The current basic life support guidelines recommend two-minute shifts for providing chest compressions when two rescuers are performing cardiopulmonary resuscitation. However, various studies have found that rescuer fatigue can occur within one minute, coupled with a decay in the quality of chest compressions. Our aim was to compare chest compression quality metrics and rescuer fatigue between alternating rescuers in performing one- and two-minute chest compressions.
Methods


This prospective randomized cross-over study was conducted at Songklanagarind Hospital, Hat Yai, Songkhla, Thailand. We enrolled sixth-year medical students and residents and randomly grouped them into pairs to perform 8 minutes of chest compression, utilizing both the one-minute and two-minute scenarios on a manikin. The primary end points were chest compression depth and rate. The secondary end points included rescuers' fatigue, respiratory rate, and heart rate.
Results


One hundred four participants were recruited. Compared with participants in the two-minute group, participants in the one-minute group had significantly higher mean (standard deviation, SD) compression depth (mm) (45.8 (7.2) vs. 44.5 (7.1),  P =0.01) but there was no difference in the mean (SD) rate (compressions per min) (116.1 (12.5) vs. 117.8 (12.4),  P =0.08), respectively. The rescuers in the one-minute group had significantly less fatigue ( P  < 0.001) and change in respiratory rate ( P  < 0.001), but there was no difference in the change of heart rate ( P =0.59) between the two groups.
Conclusion


There were a significantly higher compression depth and lower rescuer fatigue in the 1-minute chest compression group compared with the 2-minute group. This trial is registered with TCTR20170823001.",2020,"The rescuers in the one-minute group had significantly less fatigue ( P  < 0.001) and change in respiratory rate ( P  < 0.001), but there was no difference in the change of heart rate ( P =0.59) between the two groups.
","['Songklanagarind Hospital, Hat Yai, Songkhla, Thailand', 'Results\n\n\nOne hundred four participants were recruited']",['CPR Compression Rotation'],"['respiratory rate', 'mean (SD) rate', ""rescuers' fatigue, respiratory rate, and heart rate"", 'fatigue', 'compression depth and lower rescuer fatigue', 'change of heart rate', 'higher mean (standard deviation, SD) compression depth', 'chest compression depth and rate']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0062773', 'cui_str': 'Histone acetyltransferase'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",104.0,0.087756,"The rescuers in the one-minute group had significantly less fatigue ( P  < 0.001) and change in respiratory rate ( P  < 0.001), but there was no difference in the change of heart rate ( P =0.59) between the two groups.
","[{'ForeName': 'Nutthapong', 'Initials': 'N', 'LastName': 'Pechaksorn', 'Affiliation': 'Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}, {'ForeName': 'Veerapong', 'Initials': 'V', 'LastName': 'Vattanavanit', 'Affiliation': 'Critical Care Medicine Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}]",Emergency medicine international,['10.1155/2020/5479209']
2244,32953707,Clinical Outcomes of Total Hip Arthroplasty for Displaced Femoral Neck Fractures in Patients 80 Years of Age and Older Selected by Clinical Frailty Score.,"Purpose


The utility of total hip arthroplasty (THA) for the treatment of displaced femoral neck fractures in elderly patients (≥80 years of age) remains controversial as a patient's general condition is an essential factor impacting recovery. This study aims to determine if THA is a valuable option for appropriately selected elderly patients.
Materials and Methods


All patients underwent cementless THA using a direct lateral approach with a rectangular stem. Eighty-two patients ≥80 years of age underwent THA due to a displaced femoral neck. Clinical frailty scale (CFS) scores <5 were indicated for THA. The modified Harris hip score (mHHS), visual analogue scale (VAS), and patient satisfaction were used to assess outcomes.
Results


Nine of 82 patients died in the study period with another underlying disease. One, a 90-year-old male with pneumonia expired in the intensive care unit at 7-day postoperatively, while the other eight died due to causes unrelated to THA. Of the remaining 73 patients: (i) mean mHHS score increased to 80.57±21.36 at 1-year postoperatively; (ii) VAS was 2.3±0.9 points six-months postoperatively; and (iii) 78.7% of patients reported that they were very satisfied or satisfied 1-year postoperatively. The number of perioperative complications was 10.8% (9 hips) without the need for revision surgery.
Conclusion


The use of THA in patients ≥80 years of age with low CFS scores (<5) described here yielded favorable results and a relatively low rate of complications. However, a well-controlled comparative study or randomized trial is required to further refine selection criteria for THA in this patient population.",2020,"The number of perioperative complications was 10.8% (9 hips) without the need for revision surgery.
","['displaced femoral neck fractures in elderly patients (≥80 years of age', 'patients ≥80 years of age with low CFS scores (<5', 'Nine of 82 patients died in the study period with another underlying disease', 'Patients 80 Years of Age and Older Selected by Clinical Frailty Score', 'Eighty-two patients ≥80 years of age underwent THA due to a displaced femoral neck', 'appropriately selected elderly patients']","['THA', 'Total Hip Arthroplasty', 'cementless THA', 'total hip arthroplasty (THA']","['Clinical frailty scale (CFS) scores', 'modified Harris hip score (mHHS), visual analogue scale (VAS), and patient satisfaction', 'mean mHHS score', 'number of perioperative complications']","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",82.0,0.0348768,"The number of perioperative complications was 10.8% (9 hips) without the need for revision surgery.
","[{'ForeName': 'Suenghwan', 'Initials': 'S', 'LastName': 'Jo', 'Affiliation': 'Department of Orthopaedics, School of Medicine, Chosun University, Gwangju, Korea.'}, {'ForeName': 'Se Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Jeonbuk National University Hospital, Jeonju, Korea.'}, {'ForeName': 'Sun-Jung', 'Initials': 'SJ', 'LastName': 'Yoon', 'Affiliation': 'Department of Orthopedic Surgery, Jeonbuk National University Hospital, Jeonju, Korea.'}]",Hip & pelvis,['10.5371/hp.2020.32.3.148']
2245,32953816,Comparison between a transurethral prostate split and transurethral prostate resection for benign prostatic hyperplasia treatment in a small prostate volume: a prospective controlled study.,"Background


Transurethral resection of the prostate (TURP) was considered the golden standard to treat benign prostatic hyperplasia (BPH) for decades. However, TURP was associated with low efficiency to alleviate the lower urinary tract symptoms (LUTS) and a significantly higher risk of bladder neck contracture (BNC) for patients with small-volume BPH. Our study aims to compare the therapeutic effect of a transurethral split of the prostate (TUSP) with TURP for patients with small-volume BPH (<30 mL).
Methods


In this study, 101 small-volume BPH patients were randomly divided into two groups (TUSP and TURP group). The patient's baseline characteristics and perioperative outcomes were recorded. The follow-up was done at six months, one year and two years after surgical treatment.
Results


No significant differences were observed between the two groups for the baseline characteristics, including age, prostate volume, prostate-specific antigen (PSA) level, concurrent disease, post-void residual (PVR), maximum urinary flow rate (Q max ), international prostate symptoms score (IPSS), and quality of life (QoL) score. The operative time and hemoglobin decrease were significantly lower in the TUSP group compared to the TURP group. However, no significant differences were observed between both groups for catheterization time, postoperative hospital stay, and incidence of transurethral resection syndrome (TURS). However, of the late complications, the incidence of BNC in the TUSP group was significantly lower than the TURP group. No significant differences were found between both groups for other complications, including postoperative bleeding, micturition urgency, micturition frequency, micturition pain, urinary tract infection, recatheterization, transient incontinence, and continuous incontinence. Follow-up results showed that the IPSS of the TUSP group was significantly lower than the TURP group, while the Q max  of the TUSP group was significantly higher than the TURP group.
Conclusions


This study shows that TUSP may be an efficient and safe treatment for small-volume BPH (<30 mL) with a lower incidence of postoperative BNC and better longtime clinical outcomes than TURP. It suggested that TUSP could be an ideal treatment choice for small-volume BPH.",2020,"No significant differences were found between both groups for other complications, including postoperative bleeding, micturition urgency, micturition frequency, micturition pain, urinary tract infection, recatheterization, transient incontinence, and continuous incontinence.","['101 small-volume BPH patients', 'patients with small-volume BPH (<30 mL']","['transurethral prostate split and transurethral prostate resection', '\n\n\nTransurethral resection of the prostate (TURP', 'TUSP', 'TURP', 'transurethral split of the prostate (TUSP) with TURP']","['bladder neck contracture (BNC', 'lower urinary tract symptoms (LUTS', 'catheterization time, postoperative hospital stay, and incidence of transurethral resection syndrome (TURS', 'age, prostate volume, prostate-specific antigen (PSA) level, concurrent disease, post-void residual (PVR), maximum urinary flow rate (Q max ), international prostate symptoms score (IPSS), and quality of life (QoL) score', 'postoperative bleeding, micturition urgency, micturition frequency, micturition pain, urinary tract infection, recatheterization, transient incontinence, and continuous incontinence', 'operative time and hemoglobin decrease', 'incidence of BNC']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C0542404', 'cui_str': 'Stenosis of bladder neck'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0349610', 'cui_str': 'TUR syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0227716', 'cui_str': 'Structure of neck of urinary bladder'}, {'cui': 'C0009917', 'cui_str': 'Contracture'}]",101.0,0.0194367,"No significant differences were found between both groups for other complications, including postoperative bleeding, micturition urgency, micturition frequency, micturition pain, urinary tract infection, recatheterization, transient incontinence, and continuous incontinence.","[{'ForeName': 'Bohan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shigeng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Chengfang', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Chuanjun', 'Initials': 'C', 'LastName': 'Du', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Gaofei', 'Initials': 'G', 'LastName': 'He', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.'}]",Annals of translational medicine,['10.21037/atm-20-5462']
2246,32953837,"Editorial Commentary:  Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study .",,2020,,['patients with advanced renal cell carcinoma (TIVO-3'],['Tivozanib versus sorafenib'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C2827667', 'cui_str': 'tivozanib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]",[],,0.038318,,"[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Westerman', 'Affiliation': 'Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Wood', 'Affiliation': 'Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Annals of translational medicine,['10.21037/atm.2020.03.217']
2247,32953885,A Prognostic Model Based on Six Metabolism-Related Genes in Colorectal Cancer.,"An increasing number of studies have shown that abnormal metabolism processes are closely correlated with the genesis and progression of colorectal cancer (CRC). In this study, we systematically explored the prognostic value of metabolism-related genes (MRGs) for CRC patients. A total of 289 differentially expressed MRGs were screened based on The Cancer Genome Atlas (TCGA) and the Molecular Signatures Database (MSigDB), and 72 differentially expressed transcription factors (TFs) were obtained from TCGA and the Cistrome Project database. The clinical samples obtained from TCGA were randomly divided at a ratio of 7 : 3 to obtain the training group ( n  = 306) and the test group ( n  = 128). After univariate and multivariate Cox regression analyses, we constructed a prognostic model based on 6 MRGs (AOC2, ENPP2, ADA, GPD1L, ACADL, and CPT2). Kaplan-Meier survival analysis of the training group, validation group, and overall samples proved that the model had statistical significance in predicting the outcomes of patients. Independent prognosis analysis suggested that this risk score might serve as an independent prognosis factor for CRC patients. Moreover, we combined the prognostic model and the clinical characteristics in a nomogram to predict the overall survival of CRC patients. Furthermore, gene set enrichment analysis (GSEA) was conducted to identify the enriched Kyoto Encyclopedia of Genes and Genomes (KEGG) pathways in the high- and low-risk groups, which might provide novel therapeutic targets for CRC patients. We discovered through the protein-protein interaction (PPI) network and TF-MRG regulatory network that 7 hub genes were retrieved from the PPI network and 4 kinds of differentially expressed TFs (NR3C1, MYH11, MAF, and CBX7) positively regulated 4 prognosis-associated MRGs (GSTM5, PTGIS, ENPP2, and P4HA3).",2020,"Kaplan-Meier survival analysis of the training group, validation group, and overall samples proved that the model had statistical significance in predicting the outcomes of patients.","['CRC patients', 'Colorectal Cancer']",[],"['6 MRGs (AOC2, ENPP2, ADA, GPD1L, ACADL, and CPT2', 'Kaplan-Meier survival analysis', 'overall survival']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1384621', 'cui_str': 'ENPP2 protein, human'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.02242,"Kaplan-Meier survival analysis of the training group, validation group, and overall samples proved that the model had statistical significance in predicting the outcomes of patients.","[{'ForeName': 'Yuan-Lin', 'Initials': 'YL', 'LastName': 'Sun', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Hospital, Jilin University, Changchun, 130021 Jilin Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Hospital, Jilin University, Changchun, 130021 Jilin Province, China.'}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Guo', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Hospital, Jilin University, Changchun, 130021 Jilin Province, China.'}, {'ForeName': 'Zi-Hao', 'Initials': 'ZH', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Hospital, Jilin University, Changchun, 130021 Jilin Province, China.'}, {'ForeName': 'Yue-Chao', 'Initials': 'YC', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Hospital, Jilin University, Changchun, 130021 Jilin Province, China.'}]",BioMed research international,['10.1155/2020/5974350']
2248,32953913,Comparing the effect of group training and telemedicine on exercise during pregnancy: An application of the health belief model.,"INTRODUCTION


Many women refuse to exercise during pregnancy due to lack of awareness and not receiving training. The aim of this study was to investigate and compare the effect of group and telemedicine education on exercise during pregnancy by using the health belief model (HBM).
MATERIALS AND METHODS


This quasi-experimental study was carried out in 2019 in Zahedan, and a total of 135 pregnant women participated in it. Samples were randomly assigned to the following three groups: group training ( n  = 45), telemedicine ( n  = 45), and control ( n  = 45). Group training was presented in three sessions, and the telemedicine group received the educational content through mobile applications. The samples completed the HBM questionnaire before and 6 weeks after the intervention. In addition, within 6 weeks after the intervention, they completed the exercise activity schedule. SPSS software Ver. 16 (IBM Corp, Armonk, NY, USA) was used for analysis, and data were analyzed by ANOVA, Tukey's  post-hoc  test, Kruskal-Wallis test, and Mann-Whitney test.
RESULTS


After intervention, the scores of HBM constructs and exercise levels in group training, telemedicine group, and control group, respectively, were as follows: perceived susceptibility 25.91 ± 3.24, 25.51 ± 1.97, and 22.55 ± 3.78; perceived severity 27.48 ± 2.27, 25.13 ± 2.29, and 22.51 ± 3.88; perceived benefits 27.28 ± 2.97, 25.68 ± 3, and 22.8 ± 3.05; perceived barriers 10.69 ± 2.69, 10.66 ± 3.19, and 14.17 ± 3.14; cues to action 24.71 ± 4.35, 23.9 ± 2.48, and 22.84 ± 3.02; self-efficacy 26.17 ± 3.05, 25.2 ± 2.82, and 22.51 ± 3.38; and exercise levels 70.99 ± 20.43, 56.51 ± 21.99, and 37.62 ± 29.66. Group training and telemedicine led to significant improvement in all HBM constructs and exercise levels ( P  < 0.05,  P  < 0.0001, and  P  = 0.003, respectively). Group training provided more improvement than telemedicine in the scores of perceived severity ( P  < 0.0001), perceived benefits ( P  = 0.001), cues to action ( P  = 0.02), and mean exercise time ( P  = 0.001).
CONCLUSION


The results of this study showed that the HBM is a proper model for exercise education in pregnant women. It is recommended to use HBM as a group training and telehealth in promoting the rate of exercise in pregnant women.",2020,"Group training and telemedicine led to significant improvement in all HBM constructs and exercise levels ( P  < 0.05,  P  < 0.0001, and  P  = 0.003, respectively).","['pregnant women', '16', '2019 in Zahedan, and a total of 135 pregnant women participated in it', 'pregnancy']","['telemedicine education', 'group training and telemedicine', 'HBM', 'telemedicine group received the educational content through mobile applications', 'telemedicine']","['HBM questionnaire', 'mean exercise time', 'HBM constructs and exercise levels', 'scores of HBM constructs and exercise levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",135.0,0.0440616,"Group training and telemedicine led to significant improvement in all HBM constructs and exercise levels ( P  < 0.05,  P  < 0.0001, and  P  = 0.003, respectively).","[{'ForeName': 'Zahra Sheibani', 'Initials': 'ZS', 'LastName': 'Matin', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Khayat', 'Affiliation': 'Pregnancy Health Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Navidian', 'Affiliation': 'Pregnancy Health Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Fanaei', 'Affiliation': 'Pregnancy Health Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_88_20']
2249,32952429,Effect of Adjunct Psychosocial Skills Training on Social Functioning of Schizophrenia Patients Who Get Occupational Therapy in a Community Mental Health Center: A Comparative Study.,"Introduction


Antipsychotic drugs are effective in relieving symptoms in the treatment of schizophrenia, but decreased social functioning is resistant to drugs. In this study, the effect of adjunct Psychosocial Skills Training (PSST) on social functioning for schizophrenia patients who receive service in the community mental health center (CMHC) was investigated.
Method


Schizophrenia patients who received routine case management and occupational therapy in CMHC (n=22), patients receiving PSST in addition to CMHC service (n=21) and patients who were followed up in the Psychotic Disorders Outpatient Clinic as control group (n=21), three groups were formed. In the initial evaluations of the participants, the sociodemographic data form was filled. Social functioning and severity of clinical symptoms were evaluated at the beginning and at end of three-month follow-up period with the Social Functionality Scale (SFS), Personal and Social Performance Scale (PSP), Positive and Negative Syndrome Scale (PANSS).
Results


At the end of the follow-up period, there was a significant decrease in PANSS total scores, a significant increase in PSP and SFS total scores in the last test evaluations of the study groups. There was not any statistically significant change in the control group. The decrease in PANSS total score in PSST group is significantly higher than CMHC group. There was no significant difference between PSP and SFS scores between intervention groups.
Conclusion


The psychiatric rehabilitation in CMHC has a positive effect on the social functioning and clinical symptoms of schizophrenic patients. Adjunct PSST to routine service seems to help relieving clinical symptoms.",2020,"At the end of the follow-up period, there was a significant decrease in PANSS total scores, a significant increase in PSP and SFS total scores in the last test evaluations of the study groups.","['in a Community Mental Health Center', 'schizophrenic patients', 'Schizophrenia Patients', 'schizophrenia patients who receive service in the community mental health center (CMHC', 'Method\n\n\nSchizophrenia patients who received routine case management and occupational therapy in CMHC (n=22), patients receiving', 'n=21) and patients who were followed up in the Psychotic Disorders Outpatient Clinic as control group (n=21), three groups were formed']","['CMHC', 'Get Occupational Therapy', 'Adjunct Psychosocial Skills Training', 'adjunct Psychosocial Skills Training (PSST', 'PSST in addition to CMHC service']","['PSP and SFS total scores', 'PANSS total score', 'social functioning', 'Social Functioning', 'Personal and Social Performance Scale (PSP), Positive and Negative Syndrome Scale (PANSS', 'PSP and SFS scores', 'Social functioning and severity of clinical symptoms', 'PANSS total scores']","[{'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0009474', 'cui_str': 'CMHC'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0131696,"At the end of the follow-up period, there was a significant decrease in PANSS total scores, a significant increase in PSP and SFS total scores in the last test evaluations of the study groups.","[{'ForeName': 'İmran Gökçen Yilmaz', 'Initials': 'İGY', 'LastName': 'Karaman', 'Affiliation': 'Eskişehir Osmangazi University, Faculty of Medicine, Department of Psychiatry, Eskişehir, Turkey.'}, {'ForeName': 'Meltem İzcı', 'Initials': 'Mİ', 'LastName': 'Kasal', 'Affiliation': 'İzmir Katip Çelebi University Atatürk Training and Research Hospital, Department of Psychiatry, İzmir, Turkey.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'İngeç', 'Affiliation': 'İzmir Katip Çelebi University Atatürk Training and Research Hospital, Department of Psychiatry, İzmir, Turkey.'}, {'ForeName': 'Cennet', 'Initials': 'C', 'LastName': 'Yastibaş', 'Affiliation': 'Dokuz Eylül University, Department of Psychology, İzmir, Turkey.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Gülyüksel', 'Affiliation': 'İzmir Katip Çelebi University Atatürk Training and Research Hospital, Department of Psychiatry, İzmir, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Güleç', 'Affiliation': 'İzmir Katip Çelebi University Atatürk Training and Research Hospital, Department of Psychiatry, İzmir, Turkey.'}]",Noro psikiyatri arsivi,['10.29399/npa.24885']
2250,32952469,The Impact of Soft Tissue Techniques in the Management of Migraine Headache: A Randomized Controlled Trial.,"Objective


Individuals with migraine often present with postural faults and muscle tension that are associated with myofascial trigger points (MTrPs). These trigger points may be a contributory factor to the development of migraine headaches. There are many treatments aimed at eliminating MTrPs, such as soft tissue techniques, laser therapy, and needling therapies. Thus, we performed a randomized controlled trial study to investigate the efficacy of soft tissue techniques in the management of migraine headache.
Methods


This study was conducted among individuals with migraine headache in Shiraz in 2018. Forty participants were randomly divided into 2 groups: the soft tissue techniques (treatment) group and the placebo control group. Participants in the treatment group were treated over 6 sessions in 2 weeks (combined MTrP therapy and stretching). Headache parameters, drug consumption, score on the Headache Disability Index, and pressure pain threshold (PPT) were measured before and after the intervention and after a 1-month follow-up period. Data were analyzed with 2 × 3 repeated-measures analyses of variance to investigate the differences in variables between the 2 groups.
Results


Compared with baseline and the control group, the treatment group showed a significant reduction in headache parameters ( P  < .001), drug consumption ( P  < .001), and Headache Disability Index score ( P  < .001) immediately after the intervention and after a 1-month follow-up period (all  P s < .001). PPT levels increased in the treatment group in comparison with the control group ( P  < .001).
Conclusion


The soft tissue techniques were helpful for improving certain aspects of migraine, such as headache parameters, drug consumption, functional disability, and PPT levels of cervical muscles.",2019,"The soft tissue techniques were helpful for improving certain aspects of migraine, such as headache parameters, drug consumption, functional disability, and PPT levels of cervical muscles.","['Forty participants', 'individuals with migraine headache in Shiraz in 2018', 'Migraine Headache']","['Soft Tissue Techniques', 'soft tissue techniques (treatment) group and the placebo control group', 'soft tissue techniques']","['PPT levels', 'headache parameters', 'Headache parameters, drug consumption, score on the Headache Disability Index, and pressure pain threshold (PPT', 'headache parameters, drug consumption, functional disability, and PPT levels of cervical muscles', 'Headache Disability Index score', 'drug consumption']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",40.0,0.0286519,"The soft tissue techniques were helpful for improving certain aspects of migraine, such as headache parameters, drug consumption, functional disability, and PPT levels of cervical muscles.","[{'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Rezaeian', 'Affiliation': 'Department of Physical Therapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Department of Physical Therapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Nourbakhsh', 'Affiliation': 'Physical Therapy Department, University of North Georgia, Dahlonega, Georgia.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Physical Therapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Nourozi', 'Affiliation': 'Social Determinants of Health Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",Journal of chiropractic medicine,['10.1016/j.jcm.2019.12.001']
2251,32952470,Comparative Effectiveness of 2 Manual Therapy Techniques in the Management of Lumbar Radiculopathy: A Randomized Clinical Trial.,"Objective


The purpose of this study was to compare the effectiveness of Dowling's and Mulligan's manual therapy techniques on pain and disability in the management of lumbar disc herniation with radiculopathy (LDHR).
Methods


A total of 40 individuals with LDHR were randomly allocated into 2 groups, 20 participants each in PINS and SMWLM groups. Each participant was assessed at baseline, 4 weeks, and 8 weeks postintervention. The primary outcomes measured were pain (visual analog scale) and disability (Roland-Morris Disability Questionnaire). Secondary variables were quality of life (Short-Form 36 Health Survey), sciatica bothersomeness (Sciatica Bothersomeness Index), sciatica frequency (Sciatica Frequency Index), and general perception of recovery (Global Rating of Change Scale). Repeated-measures analysis of variance was used to compute within-group and between-groups interactions.
Results


No significant differences were observed in the baseline characteristics of participants in both groups. The results indicate that there were significant time effects for all outcomes in the study ( P  < .001) within each group. However, there was no significant difference between the 2 groups on any outcome variable (P > .05).
Conclusion


The findings indicate that there was no difference in pain or disability between the 2 manual therapy techniques in the management of LDHR.",2019,The findings indicate that there was no difference in pain or disability between the 2 manual therapy techniques in the management of LDHR.,"['Lumbar Radiculopathy', 'lumbar disc herniation with radiculopathy (LDHR', '40 individuals with LDHR']","[""Dowling's and Mulligan's manual therapy techniques""]","['pain and disability', 'pain or disability', 'quality of life (Short-Form 36 Health Survey), sciatica bothersomeness (Sciatica Bothersomeness Index), sciatica frequency (Sciatica Frequency Index), and general perception of recovery (Global Rating of Change Scale', 'pain (visual analog scale) and disability (Roland-Morris Disability Questionnaire']","[{'cui': 'C1263855', 'cui_str': 'Lumbar radiculopathy'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",40.0,0.0865722,The findings indicate that there was no difference in pain or disability between the 2 manual therapy techniques in the management of LDHR.,"[{'ForeName': 'Bashir', 'Initials': 'B', 'LastName': 'Bello', 'Affiliation': 'Department of Physiotherapy, Faculty of Allied Health Sciences, Bayero University, Kano, Kano, Nigeria.'}, {'ForeName': 'Musa Sani', 'Initials': 'MS', 'LastName': 'Danazumi', 'Affiliation': 'Department of Physiotherapy, Faculty of Allied Health Sciences, Bayero University, Kano, Kano, Nigeria.'}, {'ForeName': 'Bashir', 'Initials': 'B', 'LastName': 'Kaka', 'Affiliation': 'Department of Physiotherapy, Faculty of Allied Health Sciences, Bayero University, Kano, Kano, Nigeria.'}]",Journal of chiropractic medicine,['10.1016/j.jcm.2019.10.006']
2252,32952471,Pain Tolerance: The Influence of Cold or Heat Therapy.,"Objectives


Resources of heat or cold therapies have been widely used for their low cost, analgesic action and for assisting the rehabilitation of acute or chronic injuries. The objective of this study was to search for associations between skin surface temperature and pressure pain tolerance thresholds (PPTs) of healthy individuals undergoing cryotherapy and thermotherapy.
Methods


This is an experimental clinical trial with 22 healthy university students aged between 18 and 35 years. Volunteers underwent thermography and algometry assessments at 6 points in both knees before, immediately after, and 20 minutes after the application of frozen (cryotherapy) or heated (thermotherapy) gel bags in the right knee for 20 minutes. Data were analyzed by 1-way analysis of variance, Student's  t  test, and Pearson or Spearman correlation tests.
Results


There was a significant change in skin surface temperature after cryotherapy and thermotherapy, which was maintained after 20 minutes of withdrawal ( P  < .001). After the intervention, no significant differences were observed regarding the PPT compared to the baseline measurements, nor between the experimental and control knees.
Conclusion


Cryotherapy and thermotherapy produced significant changes in the temperature of the evaluated points after their application. Despite this, no differences in pain tolerance were observed, and there was little association between skin surface temperature and PPT in the knees of healthy women after application of the resources.",2019,"There was a significant change in skin surface temperature after cryotherapy and thermotherapy, which was maintained after 20 minutes of withdrawal ( P  < .001).","['22 healthy university students aged between 18 and 35 years', 'healthy individuals undergoing cryotherapy and thermotherapy']","['frozen (cryotherapy) or heated (thermotherapy) gel bags', 'Cold or Heat Therapy']","['skin surface temperature', 'Pain Tolerance', 'pain tolerance']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0020548', 'cui_str': 'Thermotherapy'}]","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0020548', 'cui_str': 'Thermotherapy'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",22.0,0.0228388,"There was a significant change in skin surface temperature after cryotherapy and thermotherapy, which was maintained after 20 minutes of withdrawal ( P  < .001).","[{'ForeName': 'Natalia C O', 'Initials': 'NCO', 'LastName': 'Vargas E Silva', 'Affiliation': 'Master Program in Health Promotion, Adventist University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Anderson L', 'Initials': 'AL', 'LastName': 'Rubio', 'Affiliation': 'Master Program in Health Promotion, Adventist University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Fabio M', 'Initials': 'FM', 'LastName': 'Alfieri', 'Affiliation': 'Master Program in Health Promotion, Adventist University of Sao Paulo, Sao Paulo, Brazil.'}]",Journal of chiropractic medicine,['10.1016/j.jcm.2019.03.002']
2253,32954765,Effect of a two-way quality feedback nursing model on patients with chronic obstructive pulmonary disease.,"BACKGROUND


In recent years, the incidence of chronic obstructive pulmonary disease (COPD) has been increasing gradually, becoming a relatively intractable public health problem faced by all of society. The corresponding conventional nursing interventions are not effective for the rehabilitation of COPD patients and cannot meet clinical needs. In this study, a new nursing model, a two-way quality feedback nursing model, was applied for the treatment of COPD patients.
METHODS


This retrospective study included 120 moderate COPD patients admitted to our hospital between January 2018 and December 2018, and the patients were equally divided into the experimental group (n=60) and the control group (n=60) according to the nursing strategy received by patients. The control group received routine nursing care, the two-way quality feedback nursing model was applied in the experimental group, and the nursing effects in the two groups were compared.
RESULTS


The patient compliance of the experimental group to nursing care was 91.67%, that of the control group was 78.33% (P<0.05), and the scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL) in the experimental group at discharge were higher than those in the control group (P<0.05).
CONCLUSIONS


The application of the two-way quality feedback nursing model in COPD patients could improve patient compliance and significantly improve the QoL of patients, with good application value.",2020,"The patient compliance of the experimental group to nursing care was 91.67%, that of the control group was 78.33% (P<0.05), and the scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL) in the experimental group at discharge were higher than those in the control group (P<0.05).
","['patients with chronic obstructive pulmonary disease', 'chronic obstructive pulmonary disease (COPD', 'COPD patients', '120 moderate COPD patients admitted to our hospital between January 2018 and December 2018, and the patients were equally divided into the experimental group (n=60) and the control group (n=60) according to the nursing strategy received by patients']","['routine nursing care, the two-way quality feedback nursing model']","['scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL', 'nursing care']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0730605', 'cui_str': 'Moderate chronic obstructive pulmonary disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0079849', 'cui_str': 'Model, Nursing'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0282165', 'cui_str': 'Environmental Impact'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028678', 'cui_str': 'nursing'}]",120.0,0.0132109,"The patient compliance of the experimental group to nursing care was 91.67%, that of the control group was 78.33% (P<0.05), and the scores for social relationship, environmental impact, psychological condition, and physiological condition of quality of life (QoL) in the experimental group at discharge were higher than those in the control group (P<0.05).
","[{'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Yinhua', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Xiaolan', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Department of Geriatrics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing, China. fangfang7778@126.com.'}]",Annals of palliative medicine,['10.21037/apm-20-1532']
2254,32954768,Randomized clinical trial to assess the mPADSS scale in recovery and home discharge after endoscopy.,"BACKGROUND


current clinical practice guidelines recommend the use of objective scales as a criterion for post-endoscopy sedation discharge.
OBJECTIVE


to assess the recovery time, complications and patient satisfaction level using the mPADSS scale.
MATERIAL AND METHODS


demographic data and medical history were collected. Vital signs, anxiety and abdominal pain were measured pre-endoscopy. Patients were randomized into a control group, discharged according to the usual practice, and the intervention group, who underwent the mPADSS scale every ten minutes, until an objective score was reached.
RESULTS


one hundred and eighteen patients were randomized (78 colonoscopies, 32 gastroscopies, three gastro + colonoscopies and 15 endoscopic retrograde cholangiopancreatographies/endoscopic ultrasound [ERCP/USE]). With regard to medical history, there were 36 cases of elevated blood pressure and 19 diabetes cases, 15 with anticoagulant/antiplatelet and 21 with hypnotic/anxiolytic medication. An average of 160 mg of propofol was required per patient, with additional flumazenil and midazolam in 49. There were two episodes of vomiting and three of mild desaturation, all of them in the control group. Sixty patients were included in the control group and 58 in the mPADSS group, who were discharged in 15 and 10 minutes on average respectively (p < 0.005); 24-48h telephone call follow-up data were available for 105 subjects. There were four readmissions (three control and one mPADSS). There were no differences in pain and post-sedation symptoms and the level of satisfaction in terms of attention and duration of stay was similar in both groups.
CONCLUSIONS


this study shows the efficiency, safety and patient satisfaction using the mPADSS scale. Thus, its use is recommend.",2020,"There were no differences in pain and post-sedation symptoms and the level of satisfaction in terms of attention and duration of stay was similar in both groups.
","['36 cases of elevated blood pressure and 19 diabetes cases, 15 with anticoagulant/antiplatelet and 21 with hypnotic/anxiolytic medication', 'Sixty patients were included in the control group and 58 in the mPADSS group, who were discharged in 15 and 10 minutes on average respectively (p < 0.005); 24-48h telephone call follow-up data were available for 105 subjects', 'one hundred and eighteen patients were randomized (78 colonoscopies, 32 gastroscopies, three', 'demographic data and medical history were collected']","['propofol', 'flumazenil and midazolam', 'gastro + colonoscopies and 15 endoscopic retrograde cholangiopancreatographies/endoscopic ultrasound [ERCP/USE']","['recovery time, complications and patient satisfaction level', 'pain and post-sedation symptoms and the level of satisfaction in terms of attention and duration of stay', 'efficiency, safety and patient satisfaction', 'Vital signs, anxiety and abdominal pain', 'vomiting']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0016293', 'cui_str': 'Flumazenil'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",118.0,0.0716134,"There were no differences in pain and post-sedation symptoms and the level of satisfaction in terms of attention and duration of stay was similar in both groups.
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'de Benito Sanz', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega, España.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Martínez de la Torre', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}, {'ForeName': 'M ª Almudena', 'Initials': 'MªA', 'LastName': 'Salvador de Las Heras', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Calleja Carbajosa', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}, {'ForeName': 'Patricia Virginia', 'Initials': 'PV', 'LastName': 'Sesma Fernández', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Pérez Sierra', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'García-Alonso', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega, España.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pérez-Miranda Castillo', 'Affiliation': 'Aparato Digestivo, Hospital Universitario Río Hortega.'}]",Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva,['10.17235/reed.2020.6420/2019']
2255,32955913,"Modulatory Effects of Triphala and Manjistha Dietary Supplementation on Human Gut Microbiota: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.","Objectives:  Triphala (which contains  Emblica officinalis, Terminalia bellerica,  and  Terminalia chebula ) and manjistha ( Rubia cordifolia ), have received increased clinical attention. The aim of the study was to evaluate the effects of triphala, manjistha, or placebo dietary supplementation on gut microbiota as such studies in humans are lacking.  Design:  This was a 4-week randomized, double-blind, placebo-controlled pilot trial.  Setting:  This trial was conducted at the University of California Davis, Department of Dermatology.  Subjects:  A total of 31 healthy human subjects were randomized to 3 groups.  Interventions:  The 3 groups were instructed to take 2,000 mg of either triphala, manjistha or placebo daily for 4 weeks.  Outcome Measures:  The impact of treatment on gut microbiota composition was evaluated following a 4-week dietary intervention by profiling fecal communities with 16S rRNA profiling in triphala ( n  = 9), manjistha ( n  = 9), or placebo ( n  = 11) treated subjects that completed the intervention.  Results:  An average of 336 phylotypes were detected in each sample (range: 161 to 648). The analysis of gut microbiota in placebo control and herb-supplemented participants indicated that responses were highly personalized, and no taxa were uniformly altered by the medicinal herb supplementation protocol. Subjects in both treatment groups displayed a trend toward decreased Firmicutes to Bacteroidetes ratio and increased relative abundance of  Akkermansia muciniphila . Both medicinal herb treatments reduced the relative abundance of Rikenellaceae, primarily reflecting changes in  Alistipes  spp.  Conclusions:  Dietary supplementation with medicinal herbs altered fecal microbial communities. Despite the lack of a clear response signature, a group of bacterial taxa were identified that were more commonly altered in herb-supplemented participants compared to placebo controls. Clinicaltrials.gov identifier NCT03477825.",2020,"Both medicinal herb treatments reduced the relative abundance of Rikenellaceae, primarily reflecting changes in  Alistipes  spp.  ","['31 healthy human subjects', 'altered fecal microbial communities', 'University of California Davis, Department of Dermatology', 'Human Gut Microbiota', 'fecal communities with 16S rRNA profiling in triphala ( n \u2009=\u20099), manjistha ( n \u2009=\u20099), or', 'Subjects']","['Dietary supplementation with medicinal herbs', 'Triphala and Manjistha Dietary Supplementation', 'placebo', 'triphala, manjistha or placebo', 'Placebo', 'triphala, manjistha, or placebo dietary supplementation']","['Firmicutes to Bacteroidetes ratio and increased relative abundance of  Akkermansia muciniphila ', 'gut microbiota composition', 'relative abundance of Rikenellaceae']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C1958185', 'cui_str': 'triphala'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C1958185', 'cui_str': 'triphala'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1490590', 'cui_str': 'Akkermansia muciniphila'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1080664', 'cui_str': 'Rikenellaceae'}]",31.0,0.466214,"Both medicinal herb treatments reduced the relative abundance of Rikenellaceae, primarily reflecting changes in  Alistipes  spp.  ","[{'ForeName': 'Christine T', 'Initials': 'CT', 'LastName': 'Peterson', 'Affiliation': 'Department of Family Medicine and Public Health, Center of Excellence for Research and Training in Integrative Health, University of California San Diego, School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Aunna', 'Initials': 'A', 'LastName': 'Pourang', 'Affiliation': 'Department of Dermatology, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Dermatology, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Jordan N', 'Initials': 'JN', 'LastName': 'Kohn', 'Affiliation': 'Department of Psychiatry, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Uchitel', 'Affiliation': 'Department of Biology, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Harjot', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Department of Naturopathic Medicine, Bastyr University San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Mills', 'Affiliation': 'Department of Family Medicine and Public Health, Center of Excellence for Research and Training in Integrative Health, University of California San Diego, School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Peterson', 'Affiliation': 'Tumor Microenvironment and Cancer Immunology Program, Sanford Burnham Prebys Medical Discovery Institute, La Jolla, CA, USA.'}, {'ForeName': 'Raja K', 'Initials': 'RK', 'LastName': 'Sivamani', 'Affiliation': 'Department of Dermatology, University of California Davis, Sacramento, CA, USA.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0148']
2256,32955934,"Reply by Kuck to Letter Regarding Article, ""Preventive or Deferred Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT): A Multicenter Randomized Trial"".",,2020,,['Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT'],['Preventive or Deferred Ablation of Ventricular Tachycardia'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}]","[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}]",[],,0.0185024,,"[{'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Kuck', 'Affiliation': 'LANS Cardio, Hamburg, Germany.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.049410']
2257,32955936,"Letter by Krisai et al Regarding Article, ""Preventive or Deferred Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT): A Multicenter Randomized Trial"".",,2020,,['Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT'],['Preventive or Deferred Ablation of Ventricular Tachycardia'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}]","[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}]",[],,0.0202076,,"[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Krisai', 'Affiliation': ""Electrophysiology and Ablation Unit and L'Institut de rythmologie et modélisation cardiaque (LIRYC), Centre hospitalier universitaire de Bordeaux, Bordeaux-Pessac, France.""}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Vlachos', 'Affiliation': ""Electrophysiology and Ablation Unit and L'Institut de rythmologie et modélisation cardiaque (LIRYC), Centre hospitalier universitaire de Bordeaux, Bordeaux-Pessac, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Jaïs', 'Affiliation': ""Electrophysiology and Ablation Unit and L'Institut de rythmologie et modélisation cardiaque (LIRYC), Centre hospitalier universitaire de Bordeaux, Bordeaux-Pessac, France.""}]",Circulation,['10.1161/CIRCULATIONAHA.120.047003']
2258,32955964,"Administration of Herbarium Mixture ( Guazuma ulmifolia/Tecoma stans ) on Metabolic Profile in Type 2 Diabetes Mellitus Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.","The use of herbarium mixture has been empirical, and the properties are not yet known. The aim of this study was to evaluate the effect of oral administration of herbarium mixture ( Guazuma ulmifolia [G. ulmifolia]/Tecoma stans [T. stans] ) on metabolic profile in patients with type 2 diabetes mellitus (T2DM). A randomized, double-blind, placebo-controlled, clinical trial was carried out in 40 patients with T2DM. They were between 40 and 65 years of age, with body mass index (BMI) between 25.0 and 34.9 kg/m 2  and HbA1c >7.0%. BMI, waist circumference, fasting glucose, HbA1c, lipids, kidney, and liver function were measured. The patients were randomly assigned to receive the herbarium mixture ( G. ulmifolia/T. stans ) 400 mg before each meal, or placebo for 90 days. Herbarium mixture group showed decreased waist circumference (99 ± 14 vs. 98 ± 15 cm;  P  = .019), fasting glucose (12.0 ± 5.7 vs. 10.3 ± 5.1 mM;  P  = .019), and HbA1c (9.9% ± 2.7% vs. 8.9% ± 2.5%,  P  = .002). In conclusion, the administration of herbarium mixture ( G. ulmifolia/T. stans ) improved the glycemic profile in patients with T2DM. ClinicalTrial registration: NCT03313856 ClinicalTrials.gov.",2020,"Herbarium mixture group showed decreased waist circumference (99 ± 14 vs. 98 ± 15 cm;  P  = .019), fasting glucose (12.0 ± 5.7 vs. 10.3 ± 5.1 mM;  P  = .019), and HbA1c (9.9% ± 2.7% vs. 8.9% ± 2.5%,  P  = .002).","['40 patients with T2DM', 'Type 2 Diabetes Mellitus Patients', 'patients with type 2 diabetes mellitus (T2DM', 'They were between 40 and 65 years of age, with body mass index (BMI) between 25.0 and 34.9\u2009kg/m 2  and HbA1c >7.0', 'patients with T2DM']","['herbarium mixture', 'Herbarium Mixture ( Guazuma ulmifolia/Tecoma stans ', 'herbarium mixture ( G. ulmifolia/T. stans ) 400\u2009mg before each meal, or placebo', 'placebo', 'Placebo', 'herbarium mixture ( Guazuma ulmifolia [G. ulmifolia]/Tecoma stans [T. stans] ', 'herbarium mixture ( G. ulmifolia/T. stans ']","['waist circumference', 'BMI, waist circumference, fasting glucose, HbA1c, lipids, kidney, and liver function', 'glycemic profile', 'fasting glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C1027735', 'cui_str': 'Tecoma'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}]",40.0,0.682622,"Herbarium mixture group showed decreased waist circumference (99 ± 14 vs. 98 ± 15 cm;  P  = .019), fasting glucose (12.0 ± 5.7 vs. 10.3 ± 5.1 mM;  P  = .019), and HbA1c (9.9% ± 2.7% vs. 8.9% ± 2.5%,  P  = .002).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Pascoe-González', 'Affiliation': 'Department of Physiology, Health Science University Center, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'María Guadalupe', 'Initials': 'MG', 'LastName': 'Ramos-Zavala', 'Affiliation': 'Department of Physiology, Health Science University Center, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Buenrostro Ahued', 'Affiliation': 'Department of Physiology, Health Science University Center, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Sandra Ofelia', 'Initials': 'SO', 'LastName': 'Hernández-González', 'Affiliation': 'Medical Research Unit in Clinical Epidemiology, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Institute of Social Security, Guadalajara, Mexico.'}, {'ForeName': 'Ernesto Germán', 'Initials': 'EG', 'LastName': 'Cardona-Muñoz', 'Affiliation': 'Department of Physiology, Health Science University Center, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Leonel', 'Initials': 'L', 'LastName': 'García-Benavides', 'Affiliation': 'Department of Physiology, Health Science University Center, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Grover-Páez', 'Affiliation': 'Department of Physiology, Health Science University Center, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.'}]",Journal of medicinal food,['10.1089/jmf.2020.0082']
2259,32955966,Process evaluation of an autism-specific workplace tool for employers.,"BACKGROUND


Limited studies exist exploring employers' capacity in hiring and supporting employees on the autism spectrum, and even fewer have considered interventions targeting employers' skills and knowledge in enhancing employment opportunities. In response to this need, the Integrated Employment Success Tool (IEST TM ) was developed and its effectiveness established in a randomized controlled trial (RCT). Furthermore, a process evaluation was conducted to determine the usability and implementation of the IEST TM .
AIMS/OBJECTIVES


The process evaluation was conducted to determine employers' perceived usability, implementation, and perceived barriers and facilitators in using the IEST TM .
MATERIAL AND METHODS


Employers ( N  = 29) provided their feedback  via  an online questionnaire. Of these, 11 participants were interviewed, further exploring their experiences. Data were analysed  via  descriptive statistics and thematic analysis.
RESULTS


While employers' frequency and usage of the IEST TM  varied across workplaces, it was predominantly used to increase employers' knowledge of autism and implement workplace strategies. A major barrier was the paper-based format of the intervention, with more than 60% of employers indicating the need for an online version.
CONCLUSIONS AND SIGNIFICANCE


The process evaluation was a critical step in understanding  why  the IEST TM  was effective, and how it could be further optimized for prospective employers.",2020,"While employers' frequency and usage of the IEST TM  varied across workplaces, it was predominantly used to increase employers' knowledge of autism and implement workplace strategies.","['autism-specific workplace tool for employers', 'Employers ( N \u2009=\u200929', '11 participants were interviewed, further exploring their experiences']",['provided their feedback  via  an online questionnaire'],[],"[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],11.0,0.0554154,"While employers' frequency and usage of the IEST TM  varied across workplaces, it was predominantly used to increase employers' knowledge of autism and implement workplace strategies.","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Scott', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, Australia.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Falkmer', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kuzminski', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, Australia.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Falkmer', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, Australia.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Girdler', 'Affiliation': 'School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Perth, Australia.'}]",Scandinavian journal of occupational therapy,['10.1080/11038128.2020.1820571']
2260,32955967,"Randomized Phase 2 Trial of Reproxalap, a Novel Reactive Aldehyde Species Inhibitor, in Patients with Noninfectious Anterior Uveitis: Model for Corticosteroid Replacement.","Purpose:  Topical corticosteroids used to treat ocular inflammation are associated with a high risk of clinically significant toxicities. Therefore, corticosteroid-sparing medications to treat ocular inflammation are needed. Noninfectious anterior uveitis (NAU) is a sight-threatening ocular inflammatory condition typically treated with topical corticosteroids. This corticosteroid-controlled comparator trial examines the safety and efficacy of reproxalap, a novel inhibitor of reactive aldehyde species (RASP), for the treatment of ocular inflammation, by using NAU as a model.  Methods:  Forty-five patients with mild-to-moderate acute NAU were randomly assigned 1:1:1 to receive reproxalap 0.5% ophthalmic solution (4 times daily for 6 weeks), prednisolone 1% ophthalmic solution (Pred Forte ® , 4 times daily taper for 6 weeks), or a combination of reproxalap 0.5% ophthalmic solution (4 times daily for 6 weeks) and prednisolone 1% ophthalmic solution (twice daily taper for 6 weeks).  Results:  All treatments improved anterior cell count and grade, and no differences were observed in change from baseline between groups. Reproxalap monotherapy and combination therapy were statistically noninferior to prednisolone. The proportion of patients requiring rescue therapy was comparable across treatment groups. No safety issues were identified for reproxalap-treated patients, whereas treatment with prednisolone resulted in an average increase of intraocular pressure of ∼2 mm Hg.  Conclusions:  Reproxalap may be a safe and effective alternative to topical corticosteroids for patients with NAU and other forms of ocular inflammation. These results represent initial clinical evidence of the importance of RASP in ocular inflammation and the applicability of RASP inhibition to immune modulation in ocular disease. Clinical trial (NCT02406209).",2020,"All treatments improved anterior cell count and grade, and no differences were observed in change from baseline between groups.","['Noninfectious anterior uveitis (NAU', 'Methods:  Forty-five patients with mild-to-moderate acute NAU', 'Patients with Noninfectious Anterior Uveitis', 'patients with NAU and other forms of ocular inflammation']","['topical corticosteroids', 'prednisolone 1% ophthalmic solution (Pred Forte ® , 4 times daily taper for 6 weeks), or a combination of reproxalap 0.5% ophthalmic solution', 'prednisolone 1% ophthalmic solution', 'reproxalap 0.5% ophthalmic solution', 'Corticosteroid Replacement', 'prednisolone', 'Reproxalap monotherapy and combination therapy', 'reproxalap', 'Reproxalap', 'corticosteroid-sparing medications']","['proportion of patients requiring rescue therapy', 'anterior cell count and grade', 'intraocular pressure']","[{'cui': 'C0042165', 'cui_str': 'Anterior uveitis'}, {'cui': 'C0574387', 'cui_str': 'Nauruan language'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",45.0,0.122216,"All treatments improved anterior cell count and grade, and no differences were observed in change from baseline between groups.","[{'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mandell', 'Affiliation': 'Aldeyra Therapeutics, Inc., Lexington, Massachusetts, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Aldeyra Therapeutics, Inc., Lexington, Massachusetts, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Chu', 'Affiliation': 'Metropolitan Eye Research and Surgery Institute, Palisades Park, New Jersey, USA.'}, {'ForeName': 'C Stephen', 'Initials': 'CS', 'LastName': 'Foster', 'Affiliation': 'Massachusetts Eye Research and Surgery Institution, Waltham, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sheppard', 'Affiliation': 'Virginia Eye Consultants, Norfolk, Virginia, USA.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Brady', 'Affiliation': 'Aldeyra Therapeutics, Inc., Lexington, Massachusetts, USA.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2020.0056']
2261,32956008,Verbal Contingencies in the Lidcombe Program: A Noninferiority Trial.,"Purpose The Lidcombe Program is an efficacious and effective intervention for early stuttering. The treatment is based on parent verbal response contingent stimulation procedures, which are assumed to be responsible for treatment effect. The present trial tested this assumption. Method The design was a parallel, open plan, noninferiority randomized controlled trial. In the experimental arm, the five Lidcombe Program verbal contingencies were removed from parent instruction. The primary outcome was beyond-clinic percentage syllables stuttered at 18-month follow-up. Seventy-four children and their parents were randomized to one of the two treatment arms. Results Findings of noninferiority were inconclusive for the primary outcome of stuttering severity, based on a margin of 1.0 percentage syllables stuttered. Conclusions The inconclusive finding of noninferiority means it is possible that verbal contingencies make some contribution to the Lidcombe Program treatment effect. However, considering all primary and secondary outcomes, an overriding impression from the trial is a similarity of outcomes between the control and experimental arms. The clinical applications of the trial are discussed, along with further research that is needed.",2020,"Results Findings of noninferiority were inconclusive for the primary outcome of stuttering severity, based on a margin of 1.0 percentage syllables stuttered.","['Lidcombe Program', 'Seventy-four children and their parents']",['Lidcombe Program'],"['Verbal Contingencies', 'beyond-clinic percentage syllables stuttered']","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0038506', 'cui_str': 'Stuttering'}]",74.0,0.0786426,"Results Findings of noninferiority were inconclusive for the primary outcome of stuttering severity, based on a margin of 1.0 percentage syllables stuttered.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Donaghy', 'Affiliation': 'Australian Catholic University, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': ""O'Brian"", 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Onslow', 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'School of Public Health, The University of Queensland, Herston, Australia.'}, {'ForeName': 'Ross G', 'Initials': 'RG', 'LastName': 'Menzies', 'Affiliation': 'Australian Stuttering Research Centre, University of Technology Sydney, New South Wales, Australia.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00155']
2262,32956103,Blood pressure excursions in acute ischemic stroke patients treated with intravenous thrombolysis.,"OBJECTIVE


To investigate the association of blood pressure BP excursions, defined as greater than 185 SBP or greater than 105 DBP, with the probability of intracranial hemorrhage (ICH) and worse functional outcomes in patients with acute ischemic stroke (AIS) treated with tissue plasminogen activator (tPA).
METHODS


We performed a post hoc analysis of the CLOTBUST-ER trial. Serial BP measurements were conducted using automated cuff recording according to the recommended BP protocol guidelines for tPA administration. The outcomes were prespecified efficacy and safety endpoints of CLOTBUST-ER.
RESULTS


The mean number of serial BP recordings per patient was 37. Of the 674 patients, 227 (34%) had at least one BP excursion (>185/105 mmHg) during the first 24 h following tPA-bolus. The majority of BP excursions (46%) occurred within the first 75 min from tPA-bolus. Patients with at least one BP excursion in the first 24 h following tPA bolus had significantly lower rates of independent functional outcome at 90 days (31 vs. 40.1%, P = 0.028). The total number of BP excursions was associated with decreased odds of 24-h clinical recovery (OR = 0.88, 95% CI:0.80-0.96), 24-h neurological improvement (OR = 0.87, 95% CI: 0.81-0.94), 7-day functional improvement (common OR = 0.92, 95% CI: 0.87-0.97), 90-day functional improvement (common OR = 0.94, 95% CI: 0.88-0.98) and 90-day independent functional outcome (OR = 0.90, 95% CI: 0.82-0.98) in analyses adjusted for potential confounders. DBP excursions were independently associated with increased odds of any intracranial hemorrhage (OR = 1.26, 95% CI: 1.04-1.53).
CONCLUSION


BP excursions above guideline thresholds during the first 24 h following tPA administration for AIS are common and are independently associated with adverse clinical outcomes.",2020,"The total number of BP excursions was associated with decreased odds of 24-h clinical recovery (OR = 0.88, 95% CI:0.80-0.96), 24-h neurological improvement (OR = 0.87, 95% CI: 0.81-0.94), 7-day functional improvement (common OR = 0.92, 95% CI: 0.87-0.97), 90-day functional improvement (common OR = 0.94, 95% CI: 0.88-0.98) and 90-day independent functional outcome (OR = 0.90, 95% CI: 0.82-0.98) in analyses adjusted for potential confounders.","['acute ischemic stroke patients treated with', '674 patients, 227 (34%) had at least one', 'patients with acute ischemic stroke (AIS) treated with']","['tissue plasminogen activator (tPA', 'intravenous thrombolysis']","['BP excursions', 'blood pressure BP excursions', 'BP excursion', 'mean number of serial BP recordings', 'Blood pressure excursions', 'intracranial hemorrhage', 'rates of independent functional outcome', '90-day functional improvement', 'DBP excursions', '24-h clinical recovery', 'total number of BP excursions', '24-h neurological improvement', 'efficacy and safety endpoints of CLOTBUST-ER', '7-day functional improvement', 'majority of BP excursions']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",674.0,0.163019,"The total number of BP excursions was associated with decreased odds of 24-h clinical recovery (OR = 0.88, 95% CI:0.80-0.96), 24-h neurological improvement (OR = 0.87, 95% CI: 0.81-0.94), 7-day functional improvement (common OR = 0.92, 95% CI: 0.87-0.97), 90-day functional improvement (common OR = 0.94, 95% CI: 0.88-0.98) and 90-day independent functional outcome (OR = 0.90, 95% CI: 0.82-0.98) in analyses adjusted for potential confounders.","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tsivgoulis', 'Affiliation': ""Second Department of Neurology, 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Aristeidis H', 'Initials': 'AH', 'LastName': 'Katsanos', 'Affiliation': ""Second Department of Neurology, 'Attikon' University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.""}, {'ForeName': 'Pitchaiah', 'Initials': 'P', 'LastName': 'Mandava', 'Affiliation': 'Stroke Outcomes Laboratory, Department of Neurology, Baylor College of Medicine.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Köhrmann', 'Affiliation': 'Department of Neurology, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Soinne', 'Affiliation': 'Department of Neurology, Helsinki University Hospital and Clinical Neurosciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Barreto', 'Affiliation': 'Department of Neurology, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Sharma', 'Affiliation': 'Yong Loo Lin School of medicine, National University of Singapore and Division of Neurology, Department of Medicine, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mikulik', 'Affiliation': ""International Clinical Research Centre and Department of Neurology, St. Anne's University Hospital in Brno and Medical Faculty, Masaryk University, Brno, Czech Republic.""}, {'ForeName': 'Keith W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Rothlisberger', 'Affiliation': 'Cerevast Medical, Inc., Bothell, Washington.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Grotta', 'Affiliation': 'Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, Texas, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Molina', 'Affiliation': ""Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Saqqur', 'Affiliation': 'Department of Medicine (Neurology), University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Mavridis', 'Affiliation': 'Department of Primary Education, School of Education, University of Ioannina, Ioannina.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Psaltopoulou', 'Affiliation': 'Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Milan R', 'Initials': 'MR', 'LastName': 'Vosko', 'Affiliation': 'Department of Neurology 2, Med Campus III, Kepler University Hospital, Linz, Austria.'}, {'ForeName': 'Jochen B', 'Initials': 'JB', 'LastName': 'Fiebach', 'Affiliation': 'Center for Stroke Research Berlin, Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Else Charlotte', 'Initials': 'EC', 'LastName': 'Sandset', 'Affiliation': 'Department of Neurology, Stroke Unit, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Kent', 'Affiliation': 'Texas A&M Health Science Center-Houston campus, University of Texas.'}, {'ForeName': 'Anne W', 'Initials': 'AW', 'LastName': 'Alexandrov', 'Affiliation': 'Department of Neurology, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Schellinger', 'Affiliation': 'Departments of Neurology and Neurogeriatry, John Wesling Medical Center Minden, Ruhr University Bochum, Minden, Germany.'}, {'ForeName': 'Andrei V', 'Initials': 'AV', 'LastName': 'Alexandrov', 'Affiliation': 'Department of Neurology, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hypertension,['10.1097/HJH.0000000000002628']
2263,32956163,Evaluating the Associations Between Exposure to Tobacco Interventions During Inpatient Treatment and Substance Use Outcomes: Findings From a Natural Experiment.,"OBJECTIVE


In this study, we took advantage of a natural experiment that occurred within a substance use disorders (SUD) treatment setting which first saw the implementation of an evidence-based practice (EBP) for tobacco cessation, followed by the implementation of a tobacco-free policy (TFP) that included a campus-wide tobacco ban. We sought to examine how implementation of the EBP and TFP was associated with substances use outcomes, in addition to tobacco use, up to 3-months posttreatment.
METHODS


Data were collected from patients in a substance use disorders treatment program at baseline, discharge, 1-, and 3-months posttreatment. Using a quasi-experimental design and generalized estimating equations, we modelled how patients' (N = 480) exposure to one of 3 interventions (1: treatment as usual [TAU], 2: EBP, and 3: EBP + TFP) was associated with overall abstinence from tobacco, alcohol, and other substances over time. Measures of tobacco use frequency, amount, and quit attempts were also modelled among a sub-sample of participants who self-reported using tobacco before treatment.
RESULT


Exposure to the EBP + TFP was associated with increased tobacco abstinence (odds ratio [OR] = 1.93, 95% confidence interval [CI] [1.29, 2.90]) over time, including decreases in tobacco use frequency (OR = 0.78, 95% CI [0.68, 0.89]) and amount (OR = 0.80, 95% CI [0.67, 0.96]), and increased in likelihood of making a quit attempt (OR = 1.75, 95% CI [1.10, 2.80]) compared to TAU. Exposure was not associated with alcohol and/or other substance use.
CONCLUSIONS


Comprehensive tobacco interventions that include EBP + TFP can promote tobacco cessation and reduced tobacco use following inpatient SUD treatment, without adversely affecting the use of other substances.",2020,"CONCLUSIONS


Comprehensive tobacco interventions that include EBP + TFP can promote tobacco cessation and reduced tobacco use following inpatient SUD treatment, without adversely affecting the use of other substances.","['Data were collected from patients in a substance use disorders treatment program at baseline, discharge, 1-, and 3-months posttreatment']","['EBP + TFP', 'usual [TAU], 2: EBP, and 3: EBP + TFP', 'Tobacco Interventions']","['tobacco use frequency, amount, and quit attempts', 'likelihood of making a quit attempt', 'tobacco use frequency', 'tobacco abstinence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.0770679,"CONCLUSIONS


Comprehensive tobacco interventions that include EBP + TFP can promote tobacco cessation and reduced tobacco use following inpatient SUD treatment, without adversely affecting the use of other substances.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Romano', 'Affiliation': ""School of Public Health and Health Systems, University of Waterloo, Waterloo, ON (IR, MJC, SS), Homewood Research Institute, Guelph, ON (IR, MJC, SS, YL, JM, BR), Homewood Health Centre, Guelph, ON (DB, DR), Peter Boris Centre for Addiction Research, St. Joseph's Healthcare Hamilton, Hamilton, ON (JM), Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON (JM), Centre for Addiction and Mental Health, Toronto, ON (BR).""}, {'ForeName': 'Mary Jean', 'Initials': 'MJ', 'LastName': 'Costello', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sousa', 'Affiliation': ''}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bruce', 'Affiliation': ''}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Roth', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacKillop', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Rush', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000737']
2264,32956433,Effect of Short-Term Aging on the Flexural Strength of a Novel Experimental CAD/CAM Fiber-Reinforced Composite Material: A Pilot Study.,"PURPOSE


To investigate the three-point flexural strength of a novel CAD/CAM fiber-reinforced composite (FRC) material following different aging conditions.
MATERIALS AND METHODS


The specimens were randomly assigned to one of five groups based on aging condition: (1) control (no treatment); (2) short-term water storage; (3) thermal degradation with autoclaving; (4) chemical degradation with hydrochloric acid; and (5) chemical degradation with citric acid (n = 10 per group). The specimens in the control group received no treatment. Following each treatment protocol, the three-point bending test was used to calculate the flexural strength. Data were statistically analyzed (α = .05), and scanning electron microscopy (SEM) analysis of the specimens was conducted.
RESULTS


No significant differences in flexural strength were observed among the groups (P = .199). In addition, no distinct morphologic differences were detected in the SEM images of the specimens.
CONCLUSION


The flexural strength of this novel CAD/CAM FRC material was unaffected by different aging methods.",2020,No significant differences in flexural strength were observed among the groups (P = .199).,[],['aging condition: (1) control (no treatment); (2) short-term water storage; (3) thermal degradation with autoclaving; (4) chemical degradation with hydrochloric acid; and (5) chemical degradation with citric acid'],"['flexural strength of this novel CAD/CAM FRC material', 'flexural strength']",[],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0020259', 'cui_str': 'Hydrochloric Acid'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}]","[{'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0520510', 'cui_str': 'Material'}]",,0.016051,No significant differences in flexural strength were observed among the groups (P = .199).,"[{'ForeName': 'Isil', 'Initials': 'I', 'LastName': 'Cekic-Nagas', 'Affiliation': ''}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Nagas', 'Affiliation': ''}, {'ForeName': 'Ferhan', 'Initials': 'F', 'LastName': 'Egilmez', 'Affiliation': ''}, {'ForeName': 'Gulfem', 'Initials': 'G', 'LastName': 'Ergun', 'Affiliation': ''}, {'ForeName': 'Pekka K', 'Initials': 'PK', 'LastName': 'Vallittu', 'Affiliation': ''}, {'ForeName': 'Lippo', 'Initials': 'L', 'LastName': 'Lassila', 'Affiliation': ''}]",The International journal of prosthodontics,['10.11607/ijp.6428']
2265,32956446,Impact of White Blood Cell Count on Clinical Outcomes in Patients Treated with Aspirin-Free Ticagrelor Monotherapy after Percutaneous Coronary Intervention: Insights from the GLOBAL LEADERS Trial.,"AIMS


To investigate the efficacy and safety of ticagrelor monotherapy in patients undergoing percutaneous coronary intervention (PCI) stratified according to the baseline white blood cell (WBC) count.
METHODS AND RESULTS


This is a post-hoc analysis of the GLOBAL LEADERS trial, a multicentre, open-label, randomized all-comer trial in patients undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual anti-platelet therapy [DAPT]) with the reference strategy (12-month aspirin monotherapy following 12-month DAPT). Patients were stratified into two WBC groups, either < or ≥median WBC count of 7.8 x 109 cells/L (lower or higher WBC group, respectively). The primary endpoint was a composite of all-cause mortality or new Q-wave myocardial infarction (MI) at 2 years.Out of 14,576 patients included in the present study, 7,212 patients (49.5%) were classified as the lower WBC group, who had a significantly lower risk of both ischemic and bleeding outcomes at 2 years. At 2 years, the experimental strategy was associated with a significant lower incidence of the primary endpoint compared with the reference strategy in the lower WBC group (2.8% vs. 4.2%; hazard ratio [HR]: 0.67; 95% CI: 0.52-0.86) but not in the higher WBC group (4.8% vs. 4.7%; HR: 1.01; 95% CI: 0.82-1.25; pinteraction=0.013). There were no significant differences in the risks of BARC type 3 or 5 bleeding between two antiplatelet strategies regardless of the WBC groups.
CONCLUSIONS


Increased WBC counts, which may reflect degree of inflammation, at the time of index procedure may attenuate the anti-ischemic benefits of ticagrelor monotherapy observed in patients with lower WBC counts.",2020,"At 2 years, the experimental strategy was associated with a significant lower incidence of the primary endpoint compared with the reference strategy in the lower WBC group (2.8% vs. 4.2%; hazard ratio [HR]: 0.67; 95% CI: 0.52-0.86) but not in the higher WBC group (4.8% vs. 4.7%; HR: 1.01; 95% CI: 0.82-1.25; pinteraction=0.013).","['Patients Treated with Aspirin-Free Ticagrelor Monotherapy after Percutaneous Coronary Intervention', 'patients undergoing PCI', 'patients undergoing percutaneous coronary intervention (PCI) stratified according to the baseline white blood cell (WBC) count', '14,576 patients included in the present study, 7,212 patients (49.5%) were classified as the lower WBC group, who had a significantly lower risk of both ischemic and bleeding outcomes at 2 years']","['ticagrelor monotherapy following 1-month dual anti-platelet therapy [DAPT', 'ticagrelor monotherapy']","['risks of BARC type 3 or 5 bleeding', 'efficacy and safety', 'WBC counts', 'composite of all-cause mortality or new Q-wave myocardial infarction (MI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C5197905', 'cui_str': 'Dual Anti-Platelet Therapy'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",14576.0,0.0557924,"At 2 years, the experimental strategy was associated with a significant lower incidence of the primary endpoint compared with the reference strategy in the lower WBC group (2.8% vs. 4.2%; hazard ratio [HR]: 0.67; 95% CI: 0.52-0.86) but not in the higher WBC group (4.8% vs. 4.7%; HR: 1.01; 95% CI: 0.82-1.25; pinteraction=0.013).","[{'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Thoraxcentre, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Ramzi', 'Initials': 'R', 'LastName': 'Khamis', 'Affiliation': 'NHLI, Imperial College London, London, UK.'}, {'ForeName': 'Ranil', 'Initials': 'R', 'LastName': 'de Silva', 'Affiliation': 'NHLI, Imperial College London, London, UK.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital and Sigmund Freud University, Medical Faculty, Vienna, Austria.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Vrolix', 'Affiliation': 'Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Jasionowicz', 'Affiliation': 'Polsko-Amerykańskie Kliniki Serca (PAKS) Nysa, Poland.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen and Kerckhoff Heartand Thorax Center, University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), Université de Paris, Assistance Publique-Hôpitaux de Paris -Diderot, Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, University of Bern, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Cardiovascular Research Unit, Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvaa110']
2266,32956479,Efficacy of a Cycloplegic Agent Administered as a Spray in the Pediatric Population.,"PURPOSE


To evaluate the efficacy and tolerability of cyclopentolate 1% administered as a spray in pediatric patients between 3 and 6 years old.
METHODS


In this prospective, randomized, parallel group study, healthy volunteers were randomly assigned to receive cyclopentolate 1% as a single drop or a single puff into closed eyes.
RESULTS


There were 61 patients included in the study; 31 received cyclopentolate 1% as drops and 30 received cyclopentolate 1% as spray. The mean age at presentation was 4.5 ± 1.07 years (range: 3 to 6 years) and 4.2 ± 1.06 years (range: 3 to 6 years) in the drops and spray groups, respectively. The distress level was significantly lower at the time of receiving cyclopentolate as a spray (P < .0001), with the exception of patients aged 6 years. There were no significant differences in pupil diameter between the two groups (P = .51), whereas 5 of 30 patients (16.6%) with dark irises who received cyclopentolate spray did not have adequate cycloplegia to allow for accurate refraction.
CONCLUSIONS


Cycloplegia achieved with cyclopentolate 1% administered as a spray may be an option in uncooperative children because it is less distressing compared to cyclopentolate 1% drops. However, physicians should be aware that cycloplegia obtained is only partially effective in children with dark irises. [J Pediatr Ophthalmol Strabismus. 2020;57(5):301-304.].",2020,"There were no significant differences in pupil diameter between the two groups (P = .51), whereas 5 of 30 patients (16.6%) with dark irises who received cyclopentolate spray did not have adequate cycloplegia to allow for accurate refraction.
","['Pediatric Population', 'The mean age at presentation was 4.5 ± 1.07 years (range: 3 to 6 years) and 4.2 ± 1.06 years (range: 3 to 6 years) in the drops and spray groups, respectively', 'healthy volunteers', 'uncooperative children', 'pediatric patients between 3 and 6 years old', '61 patients included in the study; 31 received']","['cyclopentolate', 'Cycloplegic Agent', 'cyclopentolate 1% as spray', 'cyclopentolate spray']","['pupil diameter', 'efficacy and tolerability', 'distress level']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C4708781', 'cui_str': '1.06'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0424350', 'cui_str': 'Uncooperative behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0010582', 'cui_str': 'Cyclopentolate'}, {'cui': 'C0010586', 'cui_str': 'Cycloplegic preparation'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0232605,"There were no significant differences in pupil diameter between the two groups (P = .51), whereas 5 of 30 patients (16.6%) with dark irises who received cyclopentolate spray did not have adequate cycloplegia to allow for accurate refraction.
","[{'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Vagge', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Del Noce', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pellegrini', 'Affiliation': ''}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cappelli', 'Affiliation': ''}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Musolino', 'Affiliation': ''}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Bernabei', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Giannaccare', 'Affiliation': ''}, {'ForeName': 'Carlo E', 'Initials': 'CE', 'LastName': 'Traverso', 'Affiliation': ''}]",Journal of pediatric ophthalmology and strabismus,['10.3928/01913913-20200803-01']
2267,32956481,Superior Rectus Transposition With Medial Rectus Recession Versus Medial Rectus Recession in Esotropic Duane Retraction Syndrome.,"PURPOSE


To compare the results of augmented superior rectus transposition (with or without medial rectus recession) with simple medial rectus recession in the treatment of patients with esotropic Duane retraction syndrome.
METHODS


This was a prospective, randomized, and interventional comparative study of 20 patients with esotropic type 1 Duane retraction syndrome. Patients were randomly divided into two groups. In the first group (superior rectus transposition group), superior rectus transposition with or without medial rectus recession was performed. In the second group (non-superior rectus transposition group), unilateral medial rectus recession was performed.
RESULTS


Each group included 10 patients. Esotropia improved from 20.4 prism diopters (PD) preoperatively to 0.6 PD postoperatively in the superior rectus transposition group and from 22.5 PD preoperatively to 0.9 PD postoperatively in the non-superior rectus transposition group. Face turn improved from 11.5° preoperatively to 0.5° postoperatively in the superior rectus transposition group and from 12° preoperatively to 1.5° postoperatively in the non-superior rectus transposition group. Abduction improved in the superior rectus transposition group from -3.9 preoperatively to -3.1 postoperatively and from -3.9 preoperatively to -3.6 postoperatively in the non-superior rectus transposition group. Vertical deviation developed in two cases in the superior rectus transposition group.
CONCLUSIONS


Both superior rectus transposition and medial rectus recession are effective in the elimination of esotropia and face turn in patients with esotropic Duane retraction syndrome. Superior rectus transposition is more effective in improving abduction, but it can be complicated by vertical deviation. [J Pediatr Ophthalmol Strabismus. 2020;57(5):309-318.].",2020,Abduction improved in the superior rectus transposition group from -3.9 preoperatively to -3.1 postoperatively and from -3.9 preoperatively to -3.6 postoperatively in the non-superior rectus transposition group.,"['patients with esotropic Duane retraction syndrome', '20 patients with esotropic type 1 Duane retraction syndrome', 'Esotropic Duane Retraction Syndrome']","['unilateral medial rectus recession was performed', 'Superior Rectus Transposition With Medial Rectus Recession Versus Medial Rectus Recession', 'superior rectus transposition and medial rectus recession', 'superior rectus transposition with or without medial rectus recession', 'augmented superior rectus transposition (with or without medial rectus recession) with simple medial rectus recession']","['Abduction', 'Esotropia', 'Vertical deviation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013261', 'cui_str': ""Duane's syndrome""}, {'cui': 'C0994516', 'cui_str': 'Type 1 Duane Retraction Syndrome'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0395295', 'cui_str': 'Medial rectus recession'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582818', 'cui_str': 'Superior rectus muscle structure'}, {'cui': 'C0040674', 'cui_str': 'Transposition procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0014877', 'cui_str': 'Esotropia'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]",20.0,0.0135517,Abduction improved in the superior rectus transposition group from -3.9 preoperatively to -3.1 postoperatively and from -3.9 preoperatively to -3.6 postoperatively in the non-superior rectus transposition group.,"[{'ForeName': 'Mohamed E I', 'Initials': 'MEI', 'LastName': 'Abdallah', 'Affiliation': ''}, {'ForeName': 'Elsayed M', 'Initials': 'EM', 'LastName': 'Eltoukhi', 'Affiliation': ''}, {'ForeName': 'Ahmed R', 'Initials': 'AR', 'LastName': 'Awadein', 'Affiliation': ''}, {'ForeName': 'Rasha H', 'Initials': 'RH', 'LastName': 'Zedan', 'Affiliation': ''}]",Journal of pediatric ophthalmology and strabismus,['10.3928/01913913-20200506-02']
2268,32956506,Alkalinized lidocaine solution as a first-line local anesthesia protocol for intradetrusor injection of onabotulinum toxin A: Results from a double-blinded randomized controlled trial.,"AIMS


Local anesthesia protocols for intradetrusor onabotulinum toxin A (BoNTA) injection lack standardization. We aimed to determine if an alkalinized lidocaine solution is more effective than lidocaine only.
METHODS


Patients of both genders aged 18 or above enlisted for intradetrusor BoNTA injection (idiopathic, neurogenic, and bladder pain syndrome) were included in a double-blinded randomized controlled trial after obtaining their informed consent. All participants filled a bladder diary and a urine culture was performed. Subjects were randomized 1:1 to Protocol A (20 ml 2% lidocaine + 10 ml 8.4% sodium bicarbonate) or Protocol B (20 ml 2% lidocaine + 10 ml 0.9% saline solution). A Numeric Rating Scale (0-10) was used to assess the level of pain immediately after the procedure (primary endpoint). Secondary endpoints included pain after 1 h, urinary tract infection, acute urinary retention, and hematuria related to the procedure.
RESULTS


A total of 116 patients were randomized. Baseline characteristics (age, sex, indication, and bladder diary parameters) of patients in Group A and B were similar. Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01). No differences were observed 1 h after treatment (Protocol A and B, respectively, 0.54 ± 0.17 vs. 0.69 ± 0.19, p = .487). The only adverse event reported was mild-to-moderate self-limited hematuria in 15.4% of patients.
CONCLUSIONS


The use of an alkalinized lidocaine solution has proven to be significantly superior to lidocaine only as local anesthesia before intradetrusor BoNTA injection, suggesting that this may be considered a first-line option.",2020,"Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01).","['Patients of both genders aged 18 or above enlisted for intradetrusor BoNTA injection (idiopathic, neurogenic, and bladder pain syndrome', '116 patients were randomized']","['Alkalinized lidocaine solution', 'lidocaine\u2009+\u200910\u2009ml 8.4% sodium bicarbonate) or Protocol B (20\u2009ml 2% lidocaine\u2009', 'lidocaine', 'alkalinized lidocaine solution']","['level of pain', 'Pain scores', 'pain after 1\u2009h, urinary tract infection, acute urinary retention, and hematuria related to the procedure', 'Numeric Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C1720830', 'cui_str': 'Bladder Pain Syndrome'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",116.0,0.555031,"Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 ± 0.31 vs. 4.44 ± 0.36, p < .01).","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pereira E Silva', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ponte', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Lopes', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Palma Dos Reis', 'Affiliation': 'Department of Urology, Centro Hospitalar Universitário Lisboa Norte, Lisboa, Portugal.'}]",Neurourology and urodynamics,['10.1002/nau.24519']
2269,32956528,"Making use of three-dimensional models of teeth, manufactured by stereolithographic technology, in practical teaching of endodontics.","INTRODUCTION


Making use of 3D printed teeth models in teaching students offers an innovative approach. The mistakes made by the students at the access cavity stage were assessed with the aid of 3D models, as well as their overall, hands-on learning progress was evaluated.
MATERIAL AND METHODS


Ninety 3D models of teeth were constructed using stereolithographic technology and then randomly divided into 9 groups. One dentistry student was randomly assigned to each group; then performed primary access cavity in 10 identical 3D models. Then the teeth were evaluated in the order of their preparation, relative to the model tooth.
RESULTS


The material of 14 (15.5%) out of 90 teeth models sustained significant damage during the preparation. As regards the remaining 76 (84.5%) 3D models, the students committed the greatest number of mistakes on the incisors, and fewer on the molars and the least in the premolars. The difference in the number of errors between particular groups of teeth was statistically significant (p=0.0001). The number of errors committed in subsequent repetitions among all students was significantly different for the incisors (p=0.00215) and premolars (p=0.00383), whereas insignificant in the case of molars (p= 0.77116).
CONCLUSIONS


Thanks to perfect representation of teeth anatomy, making use of 3D models in the teaching of endodontics may well be recommended as holding substantial potential in improving overall quality of training at the preclinical stage, with a view to appreciably reducing overall risk of encountering complications during the actual clinical work.",2020,The difference in the number of errors between particular groups of teeth was statistically significant (p=0.0001).,['Ninety 3D models of teeth were constructed using'],['stereolithographic technology'],"['number of errors', 'number of errors committed in subsequent repetitions']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",90.0,0.0197643,The difference in the number of errors between particular groups of teeth was statistically significant (p=0.0001).,"[{'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Kustra', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Institute of Dentistry, Faculty of Medicine, Jagiellonian University Medical College, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Dobroś', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Institute of Dentistry, Faculty of Medicine, Jagiellonian University Medical College, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Zarzecka', 'Affiliation': 'Department of Conservative Dentistry with Endodontics, Institute of Dentistry, Faculty of Medicine, Jagiellonian University Medical College, Poland.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12604']
2270,32956551,The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: soft tissue findings from a randomized controlled clinical trial.,"AIM


to compare soft tissue dimensional changes and relative differences in soft and hard tissue volumes 4 months after single tooth extraction and 3 different treatment modalities: spontaneous healing (SH) and alveolar ridge preservation by means of a deproteneized bovine bone mineral and a collagen matrix, with (IMPL/DBBM/CM) or without (DBBM/CM) immediate implant placement.
MATERIALS AND METHODS


STL files from study casts obtained at baseline and after 4 months were matched to calculate buccal soft tissues linear and volumetric changes. DICOM file from CBCTs were superimposed to STL files allowing the evaluation of soft tissue thickness at baseline and 4 month.
RESULTS


mean horizontal reduction accounted for 1.46 ± 0,20 (SH), 0.85 ± 0.38 (DBBM-CM) and 0.84 ± 0,30 IMPL/DBBM-CM, with no statistically differences. Soft tissue thickness had a significant mean increase of 0.95 for SH group, compared to a non-significant mean decrease for DBBM-CM (0.20) and IMPL/DBBM-CM group (0.07).
CONCLUSION


a preservation technique with DBBM-CM, with or without immediate implant placement, didn't reduce the horizontal linear and volumetric changes at the buccal soft tissue profile significantly at 4 months after tooth extraction when compared to spontaneous healing. This is due to a significant increase in soft tissue thickness in spontaneously healing sites.",2020,", didn't reduce the horizontal linear and volumetric changes at the buccal soft tissue profile significantly at 4 months after tooth extraction when compared to spontaneous healing.",[],"['deproteneized bovine bone mineral and a collagen matrix, with (IMPL/DBBM/CM) or without (DBBM/CM) immediate implant placement', 'immediate implant placement', 'DBBM-CM, with or without immediate implant placement']","['Soft tissue thickness', 'soft tissue thickness', 'alveolar ridge preservation', 'horizontal linear and volumetric changes at the buccal soft tissue profile', 'DBBM-CM', 'mean horizontal reduction']",[],"[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0258817,", didn't reduce the horizontal linear and volumetric changes at the buccal soft tissue profile significantly at 4 months after tooth extraction when compared to spontaneous healing.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Clementini', 'Affiliation': 'Department of Periodontology, Università Vita-Salute, Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Castelluzzo', 'Affiliation': 'Department of Periodontology, Università Vita-Salute, Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ciaravino', 'Affiliation': 'Department of Periodontology, Università Vita-Salute, Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Agostinelli', 'Affiliation': 'Department of Periodontology, Università Vita-Salute, Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vignoletti', 'Affiliation': 'Department of Periodontology, Università Vita-Salute, Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ambrosi', 'Affiliation': 'Department of Periodontology, Università Vita-Salute, Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Sanctis', 'Affiliation': 'Department of Periodontology, Università Vita-Salute, Ospedale San Raffaele, Milan, Italy.'}]",Journal of clinical periodontology,['10.1111/jcpe.13369']
2271,32956615,A national consensus management pathway for paediatric inflammatory multisystem syndrome temporally associated with COVID-19 (PIMS-TS): results of a national Delphi process.,"Paediatric inflammatory multisystem syndrome temporally associated with COVID-19 (PIMS-TS) is a novel condition that was first reported in April, 2020. We aimed to develop a national consensus management pathway for the UK to provide guidance for clinicians caring for children with PIMS-TS. A three-phase online Delphi process and virtual consensus meeting sought consensus over the investigation, management, and research priorities from multidisciplinary clinicians caring for children with PIMS-TS. We used 140 consensus statements to derive a consensus management pathway that describes the initial investigation of children with suspected PIMS-TS, including blood markers to help determine the severity of disease, an echocardiogram, and a viral and septic screen to exclude other infectious causes of illness. The importance of a multidisciplinary team in decision making for children with PIMS-TS is highlighted throughout the guidance, along with the recommended treatment options, including supportive care, intravenous immunoglobulin, methylprednisolone, and biological therapies. These include IL-1 antagonists (eg, anakinra), IL-6 receptor blockers (eg, tocilizumab), and anti-TNF agents (eg, infliximab) for children with Kawasaki disease-like phenotype and non-specific presentations. Use of a rapid online Delphi process has made it possible to generate a national consensus pathway in a timely and cost-efficient manner in the middle of a global pandemic. The consensus statements represent the views of UK clinicians and are applicable to children in the UK suspected of having PIMS-TS. Future evidence will inform updates to this guidance, which in the interim provides a solid framework to support clinicians caring for children with PIMS-TS. This process has directly informed new PIMS-TS specific treatment groups as part of the adaptive UK RECOVERY trial protocol, which is the first formal randomised controlled trial of therapies for PIMS-TS globally.",2020,We aimed to develop a national consensus management pathway for the UK to provide guidance for clinicians caring for children with PIMS-TS.,"['children with Kawasaki disease-like phenotype and non-specific presentations', 'children with PIMS-TS']","['COVID-19 (PIMS-TS', 'IL-6 receptor blockers (eg, tocilizumab), and anti-TNF agents (eg, infliximab']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026691', 'cui_str': 'Acute febrile mucocutaneous lymph node syndrome'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}]",[],,0.0360889,We aimed to develop a national consensus management pathway for the UK to provide guidance for clinicians caring for children with PIMS-TS.,"[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Harwood', 'Affiliation': ""Department of Paediatric Surgery, Alder Hey Children's Hospital, Liverpool, UK; School of Life Sciences, University of Liverpool, Liverpool, UK. Electronic address: Rachel.Harwood@liverpool.ac.uk.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Allin', 'Affiliation': ""National Perinatal Epidemiology Unit, Nuffield Department of Health, University of Oxford, Oxford, UK; Department of Paediatric Surgery, Ozxford Children's Hospital, Oxford, UK.""}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton Foundation NHS Trust and Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Whittaker', 'Affiliation': 'Department of Paediatrics, Imperial College Healthcare NHS Trust, London, UK; Section of Paediatric Infectious Disease, Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Padmanabhan', 'Initials': 'P', 'LastName': 'Ramnarayan', 'Affiliation': ""Children's Acute Transport Service, Great Ormond Street Hospital for Children, London, UK.""}, {'ForeName': 'Athimalaipet V', 'Initials': 'AV', 'LastName': 'Ramanan', 'Affiliation': 'Department of Paediatric Rheumatology, Bristol Royal Hospital for Children, Bristol, UK; Royal National Hospital for Rheumatic Diseases, Bath, UK; University of Bristol, Bristol, UK.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Kaleem', 'Affiliation': ""Department of Paediatric Radiology, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Tulloh', 'Affiliation': 'Department of Paediatric Cardiology, Bristol Royal Hospital for Children, Bristol, UK; University of Bristol, Bristol, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'University College London Great Ormond Street Institute of Child Health and Great Ormond Street Hospital NHS Trust, NIHR Biomedical Research Centre, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Almond', 'Affiliation': ""Department of Paediatric Surgery, Alder Hey Children's Hospital, Liverpool, UK; School of Life Sciences, University of Liverpool, Liverpool, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Davis', 'Affiliation': 'Paediatric Intensive Care Unit, Bristol Royal Hospital for Children, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levin', 'Affiliation': 'Department of Paediatrics, Imperial College Healthcare NHS Trust, London, UK; Section of Paediatric Infectious Disease, Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tometzki', 'Affiliation': 'Department of Paediatric Cardiology, Bristol Royal Hospital for Children, Bristol, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton Foundation NHS Trust and Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Knight', 'Affiliation': 'National Perinatal Epidemiology Unit, Nuffield Department of Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kenny', 'Affiliation': ""Department of Paediatric Surgery, Alder Hey Children's Hospital, Liverpool, UK; School of Life Sciences, University of Liverpool, Liverpool, UK; NHS England/Improvement, Redditch, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30304-7']
2272,32956682,"A feasibility study of application and potential effects of a single session transcranial direct current stimulation (tDCS) on competitive anxiety, mood state, salivary levels of cortisol and alpha amylase in elite athletes under a real-world competition.","OBJECTIVE


To examine feasibility and potential effects of a single session tDCS over the dorsolateral prefrontal cortex (DLPFC) on competitive anxiety, mood state, and autonomic and endocrine stress responses in elite archer athletes under a real world competition.
METHODS


Twelve male elite archers volunteered to participate in this pilot trial. Participants were randomized in order to take left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System) in a within-subject study design. This study included three official competitions. About 45 min before the competition, the tDCS stimulation process was started and the participants were stimulated for 20 min with 2 mA current. Psychophysiological responses, including Brunel Mood Scale and Competitive state anxiety inventory-2-revied, were collected 15 min before each competition. Additionally, salivary cortisol (sCort) and salivary alpha-amylase (sAA) were collected 1 hour and 10 min before competition as well as 10 min and 1 hour after competition.
RESULTS


Findings demonstrated that anodal tDCS was feasible and could lead to enhance mood state (vigor, tension and fatigue) and a decrease in competitive anxiety, as compared to cathodal and sham stimulation (all p < 0.05). However, self-confidence remained unaffected by the tDCS (p > 0.05). Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05). Correlations between competitive anxiety and mood states with physiological stress markers (sCort and sAA) were not significant (all p > 0.05).
CONCLUSIONS


The present study provides the first preliminary evidence that anodal tDCS over the DLPFC is feasible and could modulate competitive anxiety and physiological stress responses to the acute stress of competition (potentially by a top-down regulation of HPA and SAM systems as well as the vagal system). Findings support the notion that non-invasive brain stimulation might be advantageous to enhance sport performance under competitive situations. However, additional studies in a larger sample size and different sport activities are encouraged to substantiate the findings.",2020,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"['elite athletes under a real-world competition', 'elite archer athletes under a real world competition', 'Twelve male elite archers volunteered to participate in this pilot trial']","['anodal tDCS', 'single session transcranial Direct Current Stimulation (tDCS', 'left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System', 'single session tDCS']","['lower salivary cortisol and alpha-amylase response', 'competitive anxiety and mood states with physiological stress markers (sCort and sAA', 'competitive anxiety, mood state, salivary levels of cortisol and alpha amylase', 'competitive anxiety', 'competitive anxiety, mood state, and autonomic and endocrine stress responses', 'Psychophysiological responses, including Brunel Mood Scale and Competitive State Anxiety inventory-2-Revied', 'salivary cortisol (sCort) and salivary alpha-amylase (sAA', 'enhance mood state (vigor, tension and fatigue']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",12.0,0.0310646,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"[{'ForeName': 'Amir Hossien', 'Initials': 'AH', 'LastName': 'Mehrsafar', 'Affiliation': 'Department of Sport Psychology, Faculty of Sport Sciences, University of Tehran, Tehran, Iran. Electronic address: a.mehrsafar@ut.ac.ir.'}, {'ForeName': 'Miguel Angel Serrano', 'Initials': 'MAS', 'LastName': 'Rosa', 'Affiliation': 'Department of Psychobiology, Faculty of Psychology, University of Valencia, Valencia, Spain; Laboratory of Cognitive and Affective Neuroscience, Faculty of psychology, University of Valencia, Valencia, Spain. Electronic address: m.angel.serrano@uv.es.'}, {'ForeName': 'Ali Moghadam', 'Initials': 'AM', 'LastName': 'Zadeh', 'Affiliation': 'Department of Psychology, Faculty of Psychology and Education, University of Tehran, Tehran, Iran. Electronic address: amoghadamzadeh@ut.ac.ir.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg E, Denmark. Electronic address: gazerani@hst.aau.dk.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113173']
2273,32956694,Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters.,"OBJECTIVE


To assess the effect on hemostasis parameters of a new combined oral contraceptive (COC).
STUDY DESIGN


In this randomized, single centre, open-label, exploratory study, healthy women received either 15 mg estetrol /3 mg drospirenone (E4/DRSP) (n=39), 30 mcg ethinylestradiol /150 mcg levonorgestrel (EE/LNG) (n=30), or 20 mcg ethinylestradiol /3 mg drospirenone (EE/DRSP) (n=32) for six 28-day cycles. Blood was collected at baseline, cycle 3, and cycle 6. Median change from baseline was evaluated for procoagulant, anticoagulant, and fibrinolytic parameters, and for sex hormone-binding globulin (SHBG).
RESULTS


Median change of endogenous thrombin potential (ETP) based activated protein C sensitivity resistance (APCr) at cycle 6 was +30% for E4/DRSP, +165% for EE/LNG (p-value<0.05 vs E4/DRSP), and +219% for EE/DRSP (p-value<0.05 vs E4/DRSP). Changes to prothrombin fragment 1+2 and SHBG for E4/DRSP, EE/LNG, and EE/DRSP were +23%, +71%, and +64% (p-value<0.05 vs E4/DRSP); and +55%, +74% and +251% (p-value <0.05 vs E4/DRSP), respectively. At cycle 6, changes to other hemostasis parameters for E4/DRSP were similar or smaller than for EE/LNG or EE/DRSP.
CONCLUSIONS


In this study, changes in hemostasis parameters after treatment with 6 cycles of E4/DRSP were smaller or similar to those observed for EE/LNG. Similar, but more pronounced changes were also observed versus EE/DRSP, which supports the hypothesis that the effect of COCs on hemostasis parameters is mainly mediated by the estrogenic component. Further studies are needed to provide more insight into the venous thromboembolic risk of E4/DRSP.
IMPLICATIONS STATEMENT


This study reports that the effects on hemostasis parameters of a COC containing 15 mg E4/3 mg DRSP are less or similar to those for EE/LNG or EE/DRSP. It also demonstrates that the choice of estrogen modulates the effects of COCs on hemostasis parameters.",2020,"At cycle 6, changes to other hemostasis parameters for E4/DRSP were similar or smaller than for EE/LNG or EE/DRSP.
",['healthy women received either 15 mg estetrol /3'],"['ethinylestradiol /3', 'ethinylestradiol /150 mcg levonorgestrel (EE/LNG', 'drospirenone', 'COC containing 15 mg E4/3 mg DRSP', 'E4/DRSP', 'new combined oral contraceptive (COC', 'EE/DRSP', 'drospirenone (E4/DRSP', 'new oral contraceptive containing estetrol and drospirenone']","['hemostasis parameters', 'endogenous thrombin potential (ETP) based activated protein C sensitivity resistance (APCr']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014899', 'cui_str': '15 alpha-Hydroxyestriol'}]","[{'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009906', 'cui_str': 'Oral Contraceptives, Combined'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0014899', 'cui_str': '15 alpha-Hydroxyestriol'}]","[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0483249', 'cui_str': 'Protein C (activated)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0347076,"At cycle 6, changes to other hemostasis parameters for E4/DRSP were similar or smaller than for EE/LNG or EE/DRSP.
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Douxfils', 'Affiliation': 'Qualiblood SA, Namur, Belgium; Department of Pharmacy, Namur Thrombosis and Hemostasis Center, NAmur Research Institute for LIfe Sciences, University of Namur, Namur, Belgium.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Klipping', 'Affiliation': 'Dinox BV, Groningen, the Netherlands.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Duijkers', 'Affiliation': 'Dinox BV, Groningen, the Netherlands.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Kinet', 'Affiliation': 'Estetra SPRL, Liège, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Mawet', 'Affiliation': 'Estetra SPRL, Liège, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maillard', 'Affiliation': 'Estetra SPRL, Liège, Belgium.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Jost', 'Affiliation': 'Estetra SPRL, Liège, Belgium. Electronic address: mjost@mithra.com.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rosing', 'Affiliation': 'Department of Biochemistry, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Foidart', 'Affiliation': 'Estetra SPRL, Liège, Belgium; University of Liège, Liège, Belgium.'}]",Contraception,['10.1016/j.contraception.2020.08.015']
2274,32956698,"Growth from Birth through Six Months for Infants of Mothers in the ""Women First"" Preconception Maternal Nutrition Trial.","OBJECTIVE


To evaluate whether the fetal linear growth effects of maternal nutrition supplementation would be maintained through 6 months postnatal age.
STUDY DESIGN


The Women First trial (WF) was a multi-country individually randomized clinical trial that compared the impact of maternal nutrition supplementation initiated preconception (Arm 1) vs at ∼11 weeks gestation (Arm 2), vs. no supplement (Arm 3); the intervention was discontinued at delivery. Trial sites were Democratic Republic of Congo, Guatemala, India, and Pakistan. Analysis includes 2421 infants born to 2408 randomized women. Primary outcome was the trajectory of length-for-age Z-scores (LAZ) by arm, based on assessments at birth and 1, 3, and 6 months. We fitted longitudinal models on growth from birth to 6 months using generalized estimating equations; maternal intervention effects were evaluated, adjusting for site and baseline maternal covariates.
RESULTS


Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI, 0.15,0.35; P < .001) and 0.19 (95% CI, 0.09,0.28; P<0.001), respectively. Compared to Arm 3, average overall adjusted relative risks (95% CI) for stunting (LAZ <-2) were lower for Arms 1 and 2: 0.76 (0.66,0.87, P<0.001) and 0.77 (0.67,0.88; P<0.001), respectively.
CONCLUSIONS


Improved linear growth in early infancy observed for the 2 intervention arms supports the critical importance of maternal nutrition prior to conception and in the early phase of gestation.",2020,"RESULTS


Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI, 0.15,0.35; P < .001) and 0.19 (95% CI, 0.09,0.28; P<0.001), respectively.",['2421 infants born to 2408 randomized women'],"['maternal nutrition supplementation initiated preconception', 'maternal nutrition supplementation']",['trajectory of length-for-age Z-scores (LAZ'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1720845', 'cui_str': 'Maternal Nutritional Physiological Phenomenon'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",2408.0,0.359219,"RESULTS


Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI, 0.15,0.35; P < .001) and 0.19 (95% CI, 0.09,0.28; P<0.001), respectively.","[{'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO, USA. Electronic address: Nancy.Krebs@cuanschutz.edu.'}, {'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Hambidge', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO, USA.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Westcott', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO, USA.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Garcés', 'Affiliation': 'Institute of Nutrition in Central America and Panama (INCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Lester', 'Initials': 'L', 'LastName': 'Figueroa', 'Affiliation': 'Institute of Nutrition in Central America and Panama (INCAP), Guatemala City, Guatemala.'}, {'ForeName': 'Antoinette K', 'Initials': 'AK', 'LastName': 'Tsefu', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Adrien L', 'Initials': 'AL', 'LastName': 'Lokangaka', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, India.""}, {'ForeName': 'Sangappa M', 'Initials': 'SM', 'LastName': 'Dhaded', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, India.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumera Aziz', 'Initials': 'SA', 'LastName': 'Ali', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Carl L', 'Initials': 'CL', 'LastName': 'Bose', 'Affiliation': 'University of North Carolina, Raleigh, NC, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Columbia University Medical Center, NY, NY, USA.'}, {'ForeName': 'Vanessa R', 'Initials': 'VR', 'LastName': 'Thorsten', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'Amaanti', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'Dhuly', 'Initials': 'D', 'LastName': 'Chowdhury', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.09.032']
2275,32952978,Impact of Educational Interventions on Psychological Distress During Allogeneic Hematopoietic Stem Cell Transplantation: A Randomised Study.,"Background


Physical and psychological factors, like wrong attitudes and behaviours, can negatively influence the health outcomes of the patients receiving allogeneic hematopoietic stem cell transplantation (AHSCT). Educational interventions aiming to improve knowledge on side effects, risks, complications and preventive behaviour can reduce psychological distress, and improve quality of life (QoL). We aimed to compare a standard approach with therapeutic patient education (TPE) to analyse the impact on AHSCT patients' QoL, psychological distress and knowledge of AHSCT side effects, risks complications and preventive behaviour.
Material and methods


A prospective interventional study was conducted analysing data of 36 patients who received one of two different educational approaches, which were a standard approach (not-exposed) or TPE (exposed).
Results


In the exposed group QoL improved 14 days after transplantation (42.2 vs 25.6; p<0.03) and at time of discharge (36.6 vs 54.4; p<0.005). Anxiety and depression were better controlled in the exposed group, both at hospitalisation and discharge (anxiety: 48.1 vs 53.2; 46.4 vs 51.6. p<0.04; depression: 49 vs 55.3; 48 vs 54.3, p<0.03). Knowledge of AHSCT risks and complications improved in exposed patients, both at admission (10.1/15 vs 8/15 correct answers; p<0.01) and discharge (10.7/15 vs 8.8/15 correct answer; p<0.03).
Conclusions


The TPE for AHSCT patients improved knowledge, reduced anxiety and depression, which consequently increasing QoL. Therefore, we recommend our approach to further engage patients in the treatment plan, which should specifically take place prior to AHSCT initiation.",2020,In the exposed group QoL improved 14 days after transplantation (42.2 vs 25.6; p<0.03) and at time of discharge (36.6 vs 54.4; p<0.005).,"['patients receiving allogeneic hematopoietic stem cell transplantation (AHSCT', '36 patients who received one of two different educational approaches, which were a standard approach (not-exposed) or TPE (exposed']","['standard approach with therapeutic patient education (TPE', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'Educational Interventions']","['Anxiety and depression', 'Knowledge of AHSCT risks and complications', 'Psychological Distress', 'quality of life (QoL', 'knowledge, reduced anxiety and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}]",,0.0510103,In the exposed group QoL improved 14 days after transplantation (42.2 vs 25.6; p<0.03) and at time of discharge (36.6 vs 54.4; p<0.005).,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cioce', 'Affiliation': 'UOC Ematologia e Trapianto di Cellule Staminali Emopoietiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Franziska Michaela', 'Initials': 'FM', 'LastName': 'Lohmeyer', 'Affiliation': 'Direzione scientifica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Rossana', 'Initials': 'R', 'LastName': 'Moroni', 'Affiliation': 'Direzione scientifica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Marinella', 'Initials': 'M', 'LastName': 'Magini', 'Affiliation': 'UOC Nutrizione clinica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Giraldi', 'Affiliation': 'UOC Nutrizione clinica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Garau', 'Affiliation': 'UOC Ematologia e Trapianto di Cellule Staminali Emopoietiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Maria Carola', 'Initials': 'MC', 'LastName': 'Gifuni', 'Affiliation': 'UOC Ematologia e Trapianto di Cellule Staminali Emopoietiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Vezio', 'Initials': 'V', 'LastName': 'Savoia', 'Affiliation': 'Servizio di Psico-Oncologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Celli', 'Affiliation': 'Facoltà di Medicina e Psicologia, Università ""La Sapienza"", Roma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Botti', 'Affiliation': 'UOC Ematologia, Azienda USL-IRCCS di Reggio Emilia, Italy.'}, {'ForeName': 'Gianpaolo', 'Initials': 'G', 'LastName': 'Gargiulo', 'Affiliation': 'UOC Ematologia, Università ""Federico II"", Napoli, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bonifazi', 'Affiliation': 'Istituto di Ematologia ""Seràgnoli"", Policlinico Universitario S.Orsola-Malpighi, Bologna, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ciceri', 'Affiliation': 'IRCCS Ospedale San Raffaele, Milano, Italy.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Serra', 'Affiliation': 'Direzione SITRA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Zega', 'Affiliation': 'Direzione SITRA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Sica', 'Affiliation': 'Istituto di Ematologia, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bacigalupo', 'Affiliation': 'Istituto di Ematologia, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'De Stefano', 'Affiliation': 'Istituto di Ematologia, Università Cattolica del Sacro Cuore, Roma, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Moscato', 'Affiliation': 'Istituto di Sanità pubblica, Università Cattolica del Sacro Cuore, Roma, Italy.'}]",Mediterranean journal of hematology and infectious diseases,['10.4084/MJHID.2020.067']
2276,32953181,Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision under WALANT: A Prospective Series of 34 Patients from a Low-Resource Tertiary Setting.,"Background


Additional studies on clinical outcomes to determine the optimal time delay from injection of local anesthesia to skin incision for WALANT surgeries are needed. The authors aimed to propose the optimal time delay from local injection to skin incision for WALANT surgeries of the hand and wrist by analyzing intraoperative blood loss, postoperative pain scores, and complication rates.
Methods


Thirty-four patients were consecutively recruited and allocated by either 7-min or 30-min delay for skin incision from local injection of epinephrine with lidocaine. Intraoperative bleeding and postoperative pain scores were analyzed between both groups by Mann-Whitney  U -test, while complication rates were compared using Fisher's exact test.
Results


The present study did not find significant differences in mean intraoperative blood loss (8 ± 5.8 mL vs. 5 ± 2.2 mL,  p =0.074), complication rates (18% vs. 0%,  p =0.227), and mean pain scores (1.2 ± 0.5 vs. 1.4 ± 0.5,  p =0.307) between the 7-min and 30-min groups.
Conclusion


The authors conclude that a waiting time of 7 min from the injection of local anesthesia is sufficient to achieve comparable clinical outcomes for minor hand and wrist surgeries under WALANT.",2020,"The present study did not find significant differences in mean intraoperative blood loss (8 ± 5.8 mL vs. 5 ± 2.2 mL,  p =0.074), complication rates (18% vs. 0%,  p =0.227), and mean pain scores (1.2 ± 0.5 vs. 1.4 ± 0.5,  p =0.307) between the 7-min and 30-min groups.
","['Methods\n\n\nThirty-four patients', '34 Patients from a Low-Resource Tertiary Setting']","['Skin Incision under WALANT', 'epinephrine with lidocaine']","['mean pain scores', 'intraoperative blood loss, postoperative pain scores, and complication rates', 'mean intraoperative blood loss', 'complication rates', 'Intraoperative bleeding and postoperative pain scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}]","[{'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",34.0,0.0881853,"The present study did not find significant differences in mean intraoperative blood loss (8 ± 5.8 mL vs. 5 ± 2.2 mL,  p =0.074), complication rates (18% vs. 0%,  p =0.227), and mean pain scores (1.2 ± 0.5 vs. 1.4 ± 0.5,  p =0.307) between the 7-min and 30-min groups.
","[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Hernandez', 'Affiliation': 'Department of Orthopaedics, East Avenue Medical Center, East Avenue, Diliman, Quezon City 1101, Metro Manila, Philippines.'}, {'ForeName': 'Mamer', 'Initials': 'M', 'LastName': 'Rosario', 'Affiliation': 'Department of Orthopaedics, East Avenue Medical Center, East Avenue, Diliman, Quezon City 1101, Metro Manila, Philippines.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Mendoza-Torres', 'Affiliation': 'Department of Orthopaedics, East Avenue Medical Center, East Avenue, Diliman, Quezon City 1101, Metro Manila, Philippines.'}, {'ForeName': 'Carl Ryan Marino', 'Initials': 'CRM', 'LastName': 'Taguba', 'Affiliation': 'Department of Orthopaedics, East Avenue Medical Center, East Avenue, Diliman, Quezon City 1101, Metro Manila, Philippines.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Department of Orthopaedics, East Avenue Medical Center, East Avenue, Diliman, Quezon City 1101, Metro Manila, Philippines.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Battad', 'Affiliation': 'Department of Orthopaedics, East Avenue Medical Center, East Avenue, Diliman, Quezon City 1101, Metro Manila, Philippines.'}]",Advances in orthopedics,['10.1155/2020/9351354']
2277,32953229,Long-Term Efficacy of Subcutaneous C1 Inhibitor in Pediatric Patients with Hereditary Angioedema.,"Background:  Hereditary angioedema (HAE) due to C1 inhibitor (C1INH) deficiency is characterized by recurrent attacks of edema of the skin and mucosal tissues. Symptoms usually present during childhood (mean age at first attack, 10 years). Earlier symptom onset may predict a more severe disease course. Subcutaneous (SC) C1INH is indicated for routine prophylaxis to prevent HAE attacks in adolescents and adults. We analyzed the long-term efficacy of C1INH (SC) in subjects ≤17 years old treated in an open-label extension (OLE) of the pivotal phase III Clinical Study for Optimal Management of Preventing Angioedema with Low-Volume Subcutaneous C1 Inhibitor Replacement Therapy (COMPACT) trial.  Methods:  Eligible subjects (age ≥6 years, with ≥4 attacks over 2 consecutive months before entry into the OLE or placebo-controlled COMPACT trial) were treated with C1INH (SC) 40 or 60 IU/kg twice weekly for 52-140 weeks. Subgroup analyses by age (≤17 vs. >17 years) were performed for key efficacy endpoints.  Results:  Ten subjects were ≤17 years old [mean (range) age, 13.3 (8-16) years, 3 subjects <12 years old; exposure range, 51-133 weeks]. All 10 pediatric subjects experienced ≥50% reduction (mean, 93%) in number of attacks versus the prestudy period, with a 97% reduction in the median number of attacks/month (0.11). All subjects had <1 attack/4-week period and 4 had <1 attack/year (1 subject was attack free). No subject discontinued treatment due to a treatment-related adverse event.  Conclusions:  Data from pediatric subjects treated with C1INH (SC) for up to 2.55 years and adult subjects revealed similar efficacy. C1INH (SC) is effective and well tolerated as long-term prophylaxis in children, adolescents, and adults with HAE.",2020,"All 10 pediatric subjects experienced ≥50% reduction (mean, 93%) in number of attacks versus the prestudy period, with a 97% reduction in the median number of attacks/month (0.11).","['Pediatric Patients with Hereditary Angioedema', 'Results:  Ten subjects were ≤17 years old [mean (range) age, 13.3 (8-16) years, 3 subjects <12 years old; exposure range, 51-133 weeks', 'adolescents and adults', 'Subgroup analyses by age (≤17 vs. >17 years', 'Eligible subjects (age ≥6 years, with ≥4 attacks over 2 consecutive months before entry into the OLE or placebo-controlled COMPACT trial', 'subjects ≤17 years old treated in an open-label extension (OLE) of the pivotal phase III Clinical Study for Optimal Management of Preventing Angioedema with Low-Volume Subcutaneous C1 Inhibitor Replacement Therapy (COMPACT) trial', 'All subjects had <1 attack/4-week period and 4 had <1 attack/year (1 subject was attack free', 'children, adolescents, and adults with HAE']","['C1INH (SC', 'Subcutaneous C1 Inhibitor', 'Subcutaneous (SC) C1INH']",['number of attacks'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0002994', 'cui_str': 'Angioedema'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",10.0,0.0237439,"All 10 pediatric subjects experienced ≥50% reduction (mean, 93%) in number of attacks versus the prestudy period, with a 97% reduction in the median number of attacks/month (0.11).","[{'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': 'University of California at Irvine, Irvine, California, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Caballero', 'Affiliation': 'Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Iftikhar', 'Initials': 'I', 'LastName': 'Hussain', 'Affiliation': 'Vital Prospects Clinical Research Institute, Tulsa, Oklahoma, USA.'}, {'ForeName': 'Avner', 'Initials': 'A', 'LastName': 'Reshef', 'Affiliation': 'Barzilai Medical Centre, Ashkelon, Israel.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Birmingham, Alabama, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Baker Allergy, Asthma and Dermatology Research Center, Portland, Oregon, USA.'}, {'ForeName': 'Lawrence B', 'Initials': 'LB', 'LastName': 'Schwartz', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cicardi', 'Affiliation': 'University of Milan, Milan, Italy.'}, {'ForeName': 'Subhransu', 'Initials': 'S', 'LastName': 'Prusty', 'Affiliation': 'CSL Behring GmbH Standort Behringwerke Marburg, Marburg, Germany.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Feuersenger', 'Affiliation': 'CSL Behring GmbH Standort Behringwerke Marburg, Marburg, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Pragst', 'Affiliation': 'CSL Behring GmbH Standort Behringwerke Marburg, Marburg, Germany.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Manning', 'Affiliation': 'Medical Research of Arizona, Scottadale, Arizona, USA.'}]","Pediatric allergy, immunology, and pulmonology",['10.1089/ped.2020.1143']
2278,32953293,Comparision of Efficacy and Safety of Orlistat vs Placebo in Obese Patients in Pakistan.,"Introduction Obesity has become a rising health concern in Pakistan. Several primary measures, such as dietary restrictions and regular exercise, are taken to limit the severe consequences of obesity. Still, such measures alone have been proven to be often short term and therefore, inadequate. In this study, we will evaluate the role of pharmacological management via orlistat in obesity. Methods and Materials A total of 120 patients were enrolled in this study and were divided randomly into two groups (drug arm and placebo arm) of 60 patients each. A standard dose of 120 mg capsules of orlistat given three times a day was administered to the participants of the drug arm group. A placebo was given to the participants in the second group. Baseline investigations were conducted on day 0 of the study, and follow-up visits were planned to take place in week 24 for all participants. Any side effects or adverse events were inquired about and documented in these visits. Results In the orlistat arm, we noted a significant reduction in both body mass index (BMI) (0.04) and waist circumference (0.04). Reduction in weight was more in the orlistat arm than in the placebo arm. However, it is non-significant when compared between day 0 and week 24. Adverse events, such as oily spotting (31.91%), flatus with discharge (27.65%), faecal urgency (25.53%) and fatty stool (35.553%), were significantly higher in the orlistat arm. Conclusion Orlistat has shown positive results in reducing weight, BMI and waist circumference; however, patients should be counselled about potential side effects caused by the mechanism of action of Orlistat.",2020,"Adverse events, such as oily spotting (31.91%), flatus with discharge (27.65%), faecal urgency (25.53%) and fatty stool (35.553%), were significantly higher in the orlistat arm.","['Obese Patients in Pakistan', 'A total of 120 patients', 'arm) of 60 patients each']","['Orlistat vs Placebo', 'placebo', 'orlistat']","['body mass index (BMI) (0.04) and waist circumference', 'Adverse events, such as oily spotting', 'adverse events', 'flatus with discharge', 'Reduction in weight', 'fatty stool', 'weight, BMI\xa0and waist circumference', 'faecal urgency', 'dietary restrictions and regular exercise, are taken to limit the severe consequences of obesity']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0076275', 'cui_str': 'orlistat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517407', 'cui_str': '0.04'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0038238', 'cui_str': 'Fatty stool'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",120.0,0.0456377,"Adverse events, such as oily spotting (31.91%), flatus with discharge (27.65%), faecal urgency (25.53%) and fatty stool (35.553%), were significantly higher in the orlistat arm.","[{'ForeName': 'Asghar Hussain', 'Initials': 'AH', 'LastName': 'Syed', 'Affiliation': 'Family Medicine, Ziauddin University, Karachi, PAK.'}, {'ForeName': 'Areeba', 'Initials': 'A', 'LastName': 'Meraj', 'Affiliation': 'Internal Medicine, Civil Hospital Karachi, Karachi, PAK.'}, {'ForeName': 'Laxman', 'Initials': 'L', 'LastName': 'Bhandari', 'Affiliation': 'Internal Medicine, Nidan Hospital, Lalitpur, NPL.'}, {'ForeName': 'Faria', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': 'Internal Medicine, Dow University of Health Sciences, Karachi, PAK.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Shaikh', 'Affiliation': 'Internal Medicine, Dow University of Health Sciences, Karachi, PAK.'}, {'ForeName': 'Kanza', 'Initials': 'K', 'LastName': 'Baig', 'Affiliation': 'Internal Medicine, Jinnah Sindh Medical University, Karachi, PAK.'}, {'ForeName': 'Besham', 'Initials': 'B', 'LastName': 'Kumar', 'Affiliation': 'Internal Medicine, Jinnah Postgraduate Medical Centre, Karachi, PAK.'}]",Cureus,['10.7759/cureus.9775']
2279,32953352,Calcium Dobesilate Versus Flavonoids for the Treatment of Early Hemorrhoidal Disease: A Randomized Controlled Trial.,"Background and Aim Early hemorrhoidal disease is usually treated conservatively with fiber diet and medical therapy with flavonoids or calcium dobesilate. The purpose of this study was to compare the efficacy of these two agents in the treatment of early hemorrhoidal disease. Materials and Methods Patients having grade I and grade II hemorrhoidal disease were recruited in the study. One group received flavonoid therapy and the other group took calcium dobesilate treatment for three weeks. The symptoms and size of hemorrhoids were then assessed at the fourth week. Results  In this study, 70.2% of patients were male and 29.8% of patients were female. Of the total patients, 58.65% of patients were below 45 years of age and 41.34% of patients were above 45 years of age. Moreover, 83.65% of patients had grade II hemorrhoids, whereas 16.34% of patients had grade I hemorrhoids; 80.8% of patients showed a decrease in frequency and amount of bleeding after being treated by flavonoids, whereas 67.3% showed a decrease in frequency and amount of bleeding after administration of calcium dobesilate. A decrease in the size of hemorrhoids was seen in 67.3% of patients after treatment with flavonoids and 38.46% after giving calcium dobesilate. Conclusions Treatment of early hemorrhoidal with flavonoid therapy was more effective in improving the symptoms of disease as compared to calcium dobesilate treatment.",2020,A decrease in the size of hemorrhoids was seen in 67.3% of patients after treatment with flavonoids and 38.46% after giving calcium dobesilate.,"['having grade I and grade II hemorrhoidal disease', 'Early Hemorrhoidal Disease', 'early hemorrhoidal disease', '70.2% of patients were male and 29.8% of patients were female', 'Of the total patients, 58.65% of patients were below 45 years of age and 41.34% of patients were above 45 years of age']","['Calcium Dobesilate Versus Flavonoids', 'flavonoid therapy', 'fiber diet and medical therapy with flavonoids or calcium dobesilate']","['symptoms and size of hemorrhoids', 'frequency and amount of bleeding', 'size of hemorrhoids', 'grade II hemorrhoids']","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0006694', 'cui_str': 'calcium dobesilate'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.0383302,A decrease in the size of hemorrhoids was seen in 67.3% of patients after treatment with flavonoids and 38.46% after giving calcium dobesilate.,"[{'ForeName': 'Shabbar H', 'Initials': 'SH', 'LastName': 'Changazi', 'Affiliation': 'Surgical Special Unit, Services Hospital, Lahore, PAK.'}, {'ForeName': 'Samiullah', 'Initials': 'S', 'LastName': 'Bhatti', 'Affiliation': 'Surgery, Services Hospital, Lahore, PAK.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Choudary', 'Affiliation': 'Surgery, Services Hospital, Lahore, PAK.'}, {'ForeName': 'Muhammad Naeem Afzal', 'Initials': 'MNA', 'LastName': 'Rajput', 'Affiliation': 'Surgery, Services Hospital, Lahore, PAK.'}, {'ForeName': 'Zahid', 'Initials': 'Z', 'LastName': 'Iqbal', 'Affiliation': 'Internal Medicine, Services Hospital, Lahore, PAK.'}, {'ForeName': 'Qamar A', 'Initials': 'QA', 'LastName': 'Ahmed', 'Affiliation': 'Surgery, Services Institute of Medical Services, Lahore, PAK.'}]",Cureus,['10.7759/cureus.9845']
2280,32953920,Biomechanical Comparison of Augmentation of Engineered Tendon-Fibrocartilage-Bone Composite With Acellular Dermal Graft Using Double Rip-Stop Technique for Canine Rotator Cuff Repair.,"Background


The retear rate after rotator cuff repair remains unacceptably high. Various biological engineered scaffolds have been proposed to reduce the retear rate. We have developed a double rip-stop repair with medial row knot (DRSK) technique to enhance suture-tendon strength and a novel engineered tendon-fibrocartilage-bone composite (TFBC) for rotator cuff repair.
Hypothesis


DRSK rotator cuff repair augmented with TFBC will have better biomechanical properties than that of DRSK repair with an acellular dermal graft (DG).
Study Design


Controlled laboratory study.
Methods


Fresh-frozen canine shoulders (n = 30) and knees (n = 10) were used. TFBCs were harvested from the patellar tendon-tibia complex and prepared for rotator cuff repair. The infraspinatus tendon was sharply detached from its bony attachment and randomly assigned to the (1) control group: DRSK repair alone, (2) TFBC group: DRSK repair with TFBC, and (3) DG group: DRSK repair with DG. All specimens were tested to failure, and videos were recorded. The footprint area, tendon thickness, load to create 3-mm gap formation, failure load, failure modes, and stiffness were recorded and compared. Data were recorded as mean ± SD.
Results


The mean load to create a 3-mm gap in both the control group (206.8 ± 55.7 N) and TFBC group (208.9 ± 39.1 N) was significantly higher than that in the DG group (157.7 ± 52.3 N) ( P  < .05 for all). The failure load of the control group (275.7 ± 75.0 N) and TFBC group (275.2 ± 52.5 N) was significantly higher compared with the DG group (201.5 ± 49.7 N) ( P  < .05 for both comparisons). The stiffness of the control group (26.4 ± 4.7 N/mm) was significantly higher than of the TFBC group (20.4 ± 4.4 N/mm) and the DG group (21.1 ± 4.8 N/mm) ( P  < .05 for both comparisons).
Conclusion


TFBC augmentation showed superior biomechanical performance to DG augmentation in rotator cuff tears repaired using the DRSK technique, while there was no difference between the TFBC and control groups.
Clinical Relevance


TFBC may help to reduce retear or gap formation after rotator cuff repair using the DRSK technique.",2020,"Clinical Relevance


TFBC may help to reduce retear or gap formation after rotator cuff repair using the DRSK technique.","['Canine Rotator Cuff Repair', 'Methods\n\n\nFresh-frozen canine shoulders (n = 30) and knees (n = 10) were used']","['double rip-stop repair with medial row knot (DRSK) technique to enhance suture-tendon strength and a novel engineered tendon-fibrocartilage-bone composite (TFBC', 'DRSK repair alone, (2) TFBC group: DRSK repair with TFBC, and (3) DG group: DRSK repair with DG', 'TFBC', 'Engineered Tendon-Fibrocartilage-Bone Composite', 'Acellular Dermal Graft Using Double Rip-Stop Technique']","['TFBCs', 'failure load', 'mean load to create a 3-mm gap', 'superior biomechanical performance', 'footprint area, tendon thickness, load to create 3-mm gap formation, failure load, failure modes, and stiffness']","[{'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0297981', 'cui_str': 'RIPK1 protein, human'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0560032', 'cui_str': 'knot'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0014279', 'cui_str': 'Engineering'}, {'cui': 'C0684077', 'cui_str': 'Fibrocartilage'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0449871', 'cui_str': 'Use of graft'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",10.0,0.0701499,"Clinical Relevance


TFBC may help to reduce retear or gap formation after rotator cuff repair using the DRSK technique.","[{'ForeName': 'Zhanwen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Zeling', 'Initials': 'Z', 'LastName': 'Long', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Amadio', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gingery', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Moran', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Steinmann', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Chunfeng', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120939001']
2281,32954008,Mild inflammation causes a reduction in resting-state amplitude of low-frequency fluctuation in healthy adult males.,"Systemic inflammation has been associated with negative mood states and human sickness behaviour. Previous studies have shown an association between systemic inflammation and changes in task-related blood-oxygen-level-dependent activity and functional connectivity within large-scale networks. However, no study has examined the effect of inflammation on the magnitude of blood-oxygen-level-dependent low-frequency fluctuations at rest. We used a double-blind placebo-controlled crossover design to randomise 20 male subjects (aged 20-50 years) to receive either a  Salmonella typhi  vaccine or a placebo saline injection at two separate sessions. All participants underwent a resting-state functional magnetic resonance scan and a measure of inflammation (interleukin 6) and mood (Profile of Mood States) 3 h after injection. We compared the whole brain amplitude of low-frequency fluctuations between the vaccine and placebo conditions using a repeated measures design. Vaccine condition was associated with greater interleukin 6 levels (p < 0.001). Vaccine condition was also associated with lower amplitude of low-frequency fluctuations in the right and left frontal pole, superior frontal gyrus, paracingulate gyrus (Cluster 1) and the right mid and inferior frontal gyrus (Cluster 2) (p < 0.001, false discovery rate corrected). Lower amplitude of low-frequency fluctuations pertaining to first cluster correlated with greater total Profile of Mood States score (worse mood) (r = -0.38; p = 0.04). These results imply possible excitation/inhibition imbalance mechanisms during inflammation that may be a relevant target in psychiatric disease, especially mood disorders.",2020,"Vaccine condition was also associated with lower amplitude of low-frequency fluctuations in the right and left frontal pole, superior frontal gyrus, paracingulate gyrus (Cluster 1) and the right mid and inferior frontal gyrus (Cluster 2) (p < 0.001, false discovery rate corrected).","['20 male subjects (aged 20-50\u2009years', 'healthy adult males']","['placebo', 'Salmonella typhi  vaccine or a placebo saline injection', 'resting-state functional magnetic resonance scan']","['total Profile of Mood States score (worse mood', 'interleukin 6 levels']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036125', 'cui_str': 'Salmonella Typhi'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1509146', 'cui_str': 'Bad mood'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",20.0,0.22298,"Vaccine condition was also associated with lower amplitude of low-frequency fluctuations in the right and left frontal pole, superior frontal gyrus, paracingulate gyrus (Cluster 1) and the right mid and inferior frontal gyrus (Cluster 2) (p < 0.001, false discovery rate corrected).","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Stefanov', 'Affiliation': 'Institute of Infection, Immunity & Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McLean', 'Affiliation': 'Institute of Neurological Sciences, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Allan', 'Affiliation': 'Institute of Neurological Sciences, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cavanagh', 'Affiliation': 'Institute of Infection, Immunity & Inflammation, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Krishnadas', 'Affiliation': 'Institute of Neuroscience & Psychology, University of Glasgow, Glasgow, UK.'}]",Brain and neuroscience advances,['10.1177/2398212820949353']
2282,32954043,The effect of pain management group on chronic pain and pain related co-morbidities and symptoms. A stepped-wedge cluster randomized controlled trial. A study protocol.,"Introduction


In primary care settings, pain-management group therapy is a tool potentially cost-effective but very much underused.
Methods


Our purpose here is to provide useful scientific information on the effect of pain-management group participation on chronic pain and pain-related co-morbidities and symptoms, as well as practical information for primary and occupational health services to initiate pain-management group activity.This study will be carried out at primary care Occupational Health Helsinki (Helsinki city employees' occupational health services), with the Finnish Institute of Occupational Health as the research partner.This is a stepped-wedge cluster randomized controlled trial among both male and female municipal employees aged 18 to 65, all of whom had visited an occupational doctor, nurse, psychologist, or physiotherapist because of any chronic pain unrelated to malignant disease. An additional inclusion criterion is work disability risk being elevated, based on a short screening questionnaire (modified Örebro questionnaire). Each participant and each interviewer will be blinded at randomization.Three groups, 10 subjects in each, begin directly after recruitment with 6 weekly 2-h meetings and a follow-up meeting 6 months later. Three waiting-list groups begin 4 months later. Subjects complete self-administered questionnaires before and after the sixth meetings, also 6 months later. Primary outcomes are pain intensity, current work ability, pain self-efficacy, fear-avoidance beliefs, chronic pain acceptance, depressive symptoms, sleep problems, sickness absence days, and number of occupational health care contacts from OH's medical records.
Results


We will publish our results in a peer-reviewed scientific journals.",2020,"An additional inclusion criterion is work disability risk being elevated, based on a short screening questionnaire (modified Örebro questionnaire).","['male and female municipal employees aged 18 to 65, all of whom had visited an occupational doctor, nurse, psychologist, or physiotherapist because of any chronic pain unrelated to malignant disease', ""primary care Occupational Health Helsinki (Helsinki city employees' occupational health services""]","['pain-management group therapy', 'pain management']","[""pain intensity, current work ability, pain self-efficacy, fear-avoidance beliefs, chronic pain acceptance, depressive symptoms, sleep problems, sickness absence days, and number of occupational health care contacts from OH's medical records"", 'chronic pain and pain related co-morbidities and symptoms']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0028801', 'cui_str': 'Occupational health service'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0653411,"An additional inclusion criterion is work disability risk being elevated, based on a short screening questionnaire (modified Örebro questionnaire).","[{'ForeName': 'Marjatta', 'Initials': 'M', 'LastName': 'Reilimo', 'Affiliation': 'Occupational Health Helsinki, Helsinginkatu 24, 00101, Helsinki, Finland.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Kaila-Kangas', 'Affiliation': 'Work Ability and Working Careers, Finnish Institute of Occupational Health, P.O Box 40, FI-00032, Helsinki, Finland.'}, {'ForeName': 'Rahman', 'Initials': 'R', 'LastName': 'Shiri', 'Affiliation': 'Work Ability and Working Careers, Finnish Institute of Occupational Health, P.O Box 40, FI-00032, Helsinki, Finland.'}, {'ForeName': 'Marjukka', 'Initials': 'M', 'LastName': 'Laurola', 'Affiliation': 'Occupational Health Helsinki, Helsinginkatu 24, 00101, Helsinki, Finland.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Miranda', 'Affiliation': 'Occupational Health Helsinki, Helsinginkatu 24, 00101, Helsinki, Finland.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100577']
2283,32954067,Effect of the ASCENT Intervention to Increase Knowledge of Kidney Allocation Policy Changes Among Dialysis Providers.,"Introduction


The Allocation System Changes for Equity in Kidney Transplantation (ASCENT) trial was a cluster-randomized pragmatic, effectiveness-implementation study designed to test whether a multicomponent educational intervention targeting leadership, clinic staff, and patients in dialysis facilities improved knowledge and awareness of the 2014 Kidney Allocation System (KAS) change.
Methods


Participants included 690 dialysis facility medical directors, nephrologists, social workers, and other staff within 655 US dialysis facilities, with 51% ( n  = 334) in the intervention group and 49% ( n  = 321) in the control group. Intervention activities included a webinar targeting medical directors and facility staff, an approximately 10-minute educational video targeting dialysis staff, an approximately 10-minute educational video targeting patients, and a facility-specific audit and feedback report of transplant performance. The control group received a standard United Network for Organ Sharing brochure. Provider knowledge was a secondary outcome of the ASCENT trial and the primary outcome of this study; knowledge was assessed as a cumulative score on a 5-point Likert scale (higher score = greater knowledge). Intention-to-treat analysis was used.
Results


At baseline, nonintervention providers had a higher mean knowledge score (mean ± SD, 2.45 ± 1.43) than intervention providers (mean ± SD, 2.31 ± 1.46). After 3 months, the average knowledge score was slightly higher in the intervention (mean ± SD, 3.14 ± 1.28) versus nonintervention providers (mean ± SD, 3.07 ± 1.24), and the estimated mean difference in knowledge scores between the groups at follow-up minus the mean difference at baseline was 0.25 (95% confidence interval [CI], 0.11-0.48;  P  = 0.039). The effect size (0.41) was low to moderate.
Conclusion


Dialysis facility provider education could help extend the impact of a national policy change in organ allocation.",2020,"At baseline, nonintervention providers had a higher mean knowledge score (mean ± SD, 2.45 ± 1.43) than intervention providers (mean ± SD, 2.31 ± 1.46).","['Methods\n\n\nParticipants included 690 dialysis facility medical directors, nephrologists, social workers, and other staff within 655 US dialysis facilities, with 51% ( n \xa0= 334) in the intervention group and 49% ( n \xa0= 321) in the control group', 'Dialysis Providers']","['multicomponent educational intervention', 'webinar targeting medical directors and facility staff, an approximately 10-minute educational video targeting dialysis staff, an approximately 10-minute educational video targeting patients, and a facility-specific audit and feedback report of transplant performance', 'standard United Network for Organ Sharing brochure', 'ASCENT Intervention']","['average knowledge score', 'cumulative score on a 5-point Likert scale', 'knowledge and awareness of the 2014 Kidney Allocation System (KAS) change', 'knowledge scores', 'mean knowledge score']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0260039', 'cui_str': 'Nephrologist'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025081', 'cui_str': 'Medical Directors'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.16502,"At baseline, nonintervention providers had a higher mean knowledge score (mean ± SD, 2.45 ± 1.43) than intervention providers (mean ± SD, 2.31 ± 1.46).","[{'ForeName': 'Wairimu', 'Initials': 'W', 'LastName': 'Magua', 'Affiliation': 'Department of Surgery, Division of Transplantation, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Mohua', 'Initials': 'M', 'LastName': 'Basu', 'Affiliation': 'Department of Surgery, Division of Transplantation, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Stephen O', 'Initials': 'SO', 'LastName': 'Pastan', 'Affiliation': 'Department of Medicine, Renal Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Joyce J', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Division of Transplantation, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Department of Surgery, Division of Transplantation, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Gander', 'Affiliation': 'Center for Research and Evaluation, Kaiser Permanente Georgia, Atlanta, Georgia, USA.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Mohan', 'Affiliation': 'Department of Medicine, Division of Nephrology, College of Physicians and Surgeons, Columbia University, New York, New York, USA.'}, {'ForeName': 'Cam', 'Initials': 'C', 'LastName': 'Escoffery', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Plantinga', 'Affiliation': 'Department of Medicine, Renal Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Melanson', 'Affiliation': 'Department of Surgery, Division of Transplantation, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Garber', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Patzer', 'Affiliation': 'Department of Surgery, Division of Transplantation, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",Kidney international reports,['10.1016/j.ekir.2020.06.027']
2284,32954239,STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial.,"Background


Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of recurrent stroke and other cardiovascular diseases and commonly suffer from reduced quality of life. We aimed to determine whether the disease management programme STROKE-CARD can prevent cardiovascular diseases and improve quality of life in these patients.
Methods


In this pragmatic open-label two-centre randomised controlled trial with blinded outcome assessment, we randomly assigned patients with acute ischaemic stroke or TIA (ABCD 2  score ≥3) in a 2:1 ratio to receive STROKE-CARD care or standard care. STROKE-CARD care is a disease management programme by a multidisciplinary stroke team that comprises a standardised 3-month visit and access to a web-based patient portal targeting risk factor management, post-stroke complications, comorbidities and cardiovascular warning signs, rehabilitation demands, and patient education, counselling, and self-empowerment. Co-primary outcomes were analysed on an intention-to-treat basis and were: (i) major cardiovascular disease events defined as nonfatal ischaemic or haemorrhagic stroke, nonfatal myocardial infarction, or vascular death occurring between hospital discharge and 12 months; and (ii) health-related quality of life at 12 months quantified with the EuroQol-5-Dimensions-3-Levels (EQ-5D-3L) overall utility score. This trial is registered with ClinicalTrials.gov, number NCT02156778.
Findings


Of 2149 patients enrolled between January 2014 and December 2017 (mean age 69 years, 41% female, 83% with ischaemic stroke, 17% with TIA), 1438 were assigned to STROKE-CARD care and 711 to standard care. Major cardiovascular disease events occurred in 78 patients in the STROKE-CARD care group (5.4%) and in 59 patients in the standard care group (8.3%) (hazard ratio, 0.63; 95% confidence interval: 0.45-0.88; P=0.007). STROKE-CARD care also led to a better EQ-5D-3L overall utility score at 12 months (P<0.001). Among pre-specified secondary outcomes, STROKE-CARD care improved all individual EQ-5D-3L dimensions and functional outcome on the modified Rankin Scale at 12 months. Post hoc explanatory analyses identified considerable demands for additional rehabilitation and refinement of preventive therapy regimes at the 3-month visit and high proportions of post-stroke complications and warning signs of imminent cardiovascular diseases within the first three months.
Interpretation


The pragmatic and easily implementable STROKE-CARD care programme reduced cardiovascular risk and improved health-related quality of life and functional outcome in patients with acute ischaemic stroke or TIA.
Funding


Tirol Kliniken, Tyrolean Health Insurance Company, Tyrol Health Care Funds, Boehringer Ingelheim, Nstim Services, Sanofi, Bayer Healthcare.",2020,"Interpretation


The pragmatic and easily implementable STROKE-CARD care programme reduced cardiovascular risk and improved health-related quality of life and functional outcome in patients with acute ischaemic stroke or TIA.
","['after acute ischaemic stroke or TIA', 'mean age 69 years, 41% female, 83% with ischaemic stroke, 17% with TIA), 1438 were assigned to STROKE-CARD care and 711 to standard care', '\n\n\nPatients with ischaemic stroke or transient ischaemic attack (TIA', 'patients with acute ischaemic stroke or TIA (ABCD 2  score ≥3) in a 2:1 ratio to receive', 'patients with acute ischaemic stroke or TIA', '2149 patients enrolled between January 2014 and December 2017']",['STROKE-CARD care or standard care'],"['EQ-5D-3L overall utility score', 'Major cardiovascular disease events', 'intention-to-treat basis and were: (i) major cardiovascular disease events defined as nonfatal ischaemic or haemorrhagic stroke, nonfatal myocardial infarction, or vascular death occurring between hospital discharge and 12 months; and (ii) health-related quality of life at 12 months quantified with the EuroQol-5-Dimensions-3-Levels (EQ-5D-3L) overall utility score', 'quality of life', 'individual EQ-5D-3L dimensions and functional outcome on the modified Rankin Scale', 'cardiovascular risk and improved health-related quality of life and functional outcome']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",2149.0,0.149713,"Interpretation


The pragmatic and easily implementable STROKE-CARD care programme reduced cardiovascular risk and improved health-related quality of life and functional outcome in patients with acute ischaemic stroke or TIA.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Willeit', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Toell', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Boehme', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Krebs', 'Affiliation': ""Department of Neurology, St. John's of God Hospital, Vienna, Austria.""}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Mayer', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': ""Department of Neurology, St. John's of God Hospital, Vienna, Austria.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Seekircher', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Tschiderer', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Willeit', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Rumpold', 'Affiliation': 'Department of Medical Psychology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Schoenherr', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Griesmacher', 'Affiliation': 'Central Institute of Medical and Chemical Laboratory Diagnostics, University Hospital of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ferrari', 'Affiliation': ""Department of Neurology, St. John's of God Hospital, Vienna, Austria.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Knoflach', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Lang', 'Affiliation': ""Department of Neurology, St. John's of God Hospital, Vienna, Austria.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kiechl', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Willeit', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100476']
2285,32954299,Backward locomotor treadmill training combined with transcutaneous spinal direct current stimulation in stroke: a randomized pilot feasibility and safety study.,"Walking impairment impacts nearly 66% of stroke survivors and is a rising cause of morbidity worldwide. Despite conventional post-stroke rehabilitative care, the majority of stroke survivors experience continued limitations in their walking speed, temporospatial dynamics and walking capacity. Hence, novel and comprehensive approaches are needed to improve the trajectory of walking recovery in stroke survivors. Herein, we test the safety, feasibility and preliminary efficacy of two approaches for post-stroke walking recovery: backward locomotor treadmill training and transcutaneous spinal direct current stimulation. In this double-blinded study, 30 chronic stroke survivors (>6 months post-stroke) with mild-severe residual walking impairment underwent six 30-min sessions (three sessions/week) of backward locomotor treadmill training, with concurrent anodal ( N  = 19) or sham transcutaneous spinal direct current stimulation ( N  = 11) over the thoracolumbar spine, in a 2:1 stratified randomized fashion. The primary outcomes were: per cent participant completion, safety and tolerability of these two approaches. In addition, we collected data on training-related changes in overground walking speed, cadence, stride length (baseline, daily, 24-h post-intervention, 2 weeks post-intervention) and walking capacity (baseline, 24-h post-intervention, 2 weeks post-intervention), as secondary exploratory aims testing the preliminary efficacy of these interventions. Eighty-seven per cent ( N  = 26) of randomized participants completed the study protocol. The majority of the study attrition involved participants with severe baseline walking impairment. There were no serious adverse events in either the backward locomotor treadmill training or transcutaneous spinal direct current stimulation approaches. Also, both groups experienced a clinically meaningful improvement in walking speed immediately post-intervention that persisted at the 2-week follow-up. However, in contrast to our working hypothesis, anodal-transcutaneous spinal direct current stimulation did not enhance the degree of improvement in walking speed and capacity, relative to backward locomotor treadmill training + sham, in our sample. Backward locomotor treadmill training and transcutaneous spinal direct current stimulation are safe and feasible approaches for walking recovery in chronic stroke survivors. Definitive efficacy studies are needed to validate our findings on backward locomotor treadmill training-related changes in walking performance. The results raise interesting questions about mechanisms of locomotor learning in stroke, and well-powered transcutaneous spinal direct current stimulation dosing studies are needed to understand better its potential role as a neuromodulatory adjunct for walking rehabilitation.",2020,There were no serious adverse events in either the backward locomotor treadmill training or transcutaneous spinal direct current stimulation approaches.,"['stroke', 'chronic stroke survivors', '30 chronic stroke survivors (>6\u2009months post-stroke) with mild-severe residual walking impairment', 'participants with severe baseline walking impairment']","['Backward locomotor treadmill training and transcutaneous spinal direct current stimulation', 'locomotor treadmill training', 'Backward locomotor treadmill training combined with transcutaneous spinal direct current stimulation', 'backward locomotor treadmill training, with concurrent anodal ( N \u2009=\u200919) or sham transcutaneous spinal direct current stimulation ( N \u2009=\u200911) over the thoracolumbar spine']","['per cent participant completion, safety and tolerability', 'overground walking speed, cadence, stride length (baseline, daily, 24-h post-intervention, 2 weeks post-intervention) and walking capacity', 'walking performance', 'serious adverse events']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}]","[{'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",30.0,0.149825,There were no serious adverse events in either the backward locomotor treadmill training or transcutaneous spinal direct current stimulation approaches.,"[{'ForeName': 'Oluwole O', 'Initials': 'OO', 'LastName': 'Awosika', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Saira', 'Initials': 'S', 'LastName': 'Matthews', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Staggs', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Pierce', 'Initials': 'P', 'LastName': 'Boyne', 'Affiliation': 'College of Allied Health and Sciences, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Rizik', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Sucharew', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Mungcal', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Rohitha', 'Initials': 'R', 'LastName': 'Moudgal', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': 'Biomechanics-Ergonomics Research Laboratories, Department of Environmental Health, University of Cincinnati Medical College, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Dunning', 'Affiliation': 'College of Allied Health and Sciences, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Woo', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Brett M', 'Initials': 'BM', 'LastName': 'Kissela', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.'}]",Brain communications,['10.1093/braincomms/fcaa045']
2286,32954301,Activity or connectivity? A randomized controlled feasibility study evaluating neurofeedback training in Huntington's disease.,"Non-invasive methods, such as neurofeedback training, could support cognitive symptom management in Huntington's disease by targeting brain regions whose function is impaired. The aim of our single-blind, sham-controlled study was to collect rigorous evidence regarding the feasibility of neurofeedback training in Huntington's disease by examining two different methods, activity and connectivity real-time functional MRI neurofeedback training. Thirty-two Huntington's disease gene-carriers completed 16 runs of neurofeedback training, using an optimized real-time functional MRI protocol. Participants were randomized into four groups, two treatment groups, one receiving neurofeedback derived from the activity of the supplementary motor area, and another receiving neurofeedback based on the correlation of supplementary motor area and left striatum activity (connectivity neurofeedback training), and two sham control groups, matched to each of the treatment groups. We examined differences between the groups during neurofeedback training sessions and after training at follow-up sessions. Transfer of training was measured by measuring the participants' ability to upregulate neurofeedback training target levels without feedback (near transfer), as well as by examining change in objective, a priori defined, behavioural measures of cognitive and psychomotor function (far transfer) before and at 2 months after training. We found that the treatment group had significantly higher neurofeedback training target levels during the training sessions compared to the control group. However, we did not find robust evidence of better transfer in the treatment group compared to controls, or a difference between the two neurofeedback training methods. We also did not find evidence in support of a relationship between change in cognitive and psychomotor function and learning success. We conclude that although there is evidence that neurofeedback training can be used to guide participants to regulate the activity and connectivity of specific regions in the brain, evidence regarding transfer of learning and clinical benefit was not robust.",2020,We found that the treatment group had significantly higher neurofeedback training target levels during the training sessions compared to the control group.,"[""Huntington's disease"", ""Thirty-two Huntington's disease gene-carriers completed 16 runs of""]","['neurofeedback derived from the activity of the supplementary motor area, and another receiving neurofeedback based on the correlation of supplementary motor area and left striatum activity (connectivity neurofeedback training', 'neurofeedback training']","['neurofeedback training target levels', 'cognitive and psychomotor function and learning success']","[{'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0010097', 'cui_str': 'Corpus striatum structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",,0.0443931,We found that the treatment group had significantly higher neurofeedback training target levels during the training sessions compared to the control group.,"[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Papoutsi', 'Affiliation': ""UCL Huntington's Disease Centre, Queen Square Institute of Neurology, University College London, London WC1B 5EH, UK.""}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Magerkurth', 'Affiliation': 'Birkbeck-UCL Centre for Neuroimaging, University College London, London WC1H 0AP, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Josephs', 'Affiliation': 'Wellcome Centre for Human Neuroimaging, Queen Square Institute of Neurology, University College London, London WC1N 3AR, UK.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'Pépés', 'Affiliation': 'University of Oxford, Harris Manchester College, Oxford OX1 3TD, UK.'}, {'ForeName': 'Temi', 'Initials': 'T', 'LastName': 'Ibitoye', 'Affiliation': ""UCL Huntington's Disease Centre, Queen Square Institute of Neurology, University College London, London WC1B 5EH, UK.""}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Reilmann', 'Affiliation': 'George Huntington Institute, 48149 Münster, Germany.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Hunt', 'Affiliation': 'Eastman Dental Institute, University College London, London WC1X 8LD, UK.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Payne', 'Affiliation': 'Eastman Dental Institute, University College London, London WC1X 8LD, UK.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Weiskopf', 'Affiliation': 'Wellcome Centre for Human Neuroimaging, Queen Square Institute of Neurology, University College London, London WC1N 3AR, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Langbehn', 'Affiliation': 'Carver College of Medicine, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Geraint', 'Initials': 'G', 'LastName': 'Rees', 'Affiliation': 'Wellcome Centre for Human Neuroimaging, Queen Square Institute of Neurology, University College London, London WC1N 3AR, UK.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Tabrizi', 'Affiliation': ""UCL Huntington's Disease Centre, Queen Square Institute of Neurology, University College London, London WC1B 5EH, UK.""}]",Brain communications,['10.1093/braincomms/fcaa049']
2287,32954315,11β-Hydroxysteroid dehydrogenase type 1 inhibition in idiopathic intracranial hypertension: a double-blind randomized controlled trial.,"Treatment options for idiopathic intracranial hypertension are limited. The enzyme 11β-hydroxysteroid dehydrogenase type 1 has been implicated in regulating cerebrospinal fluid secretion, and its activity is associated with alterations in intracranial pressure in idiopathic intracranial hypertension. We assessed therapeutic efficacy, safety and tolerability and investigated indicators of  in vivo  efficacy of the 11β-hydroxysteroid dehydrogenase type 1 inhibitor AZD4017 compared with placebo in idiopathic intracranial hypertension. A multicenter, UK, 16-week phase II randomized, double-blind, placebo-controlled trial of 12-week treatment with AZD4017 or placebo was conducted. Women aged 18-55 years with active idiopathic intracranial hypertension (>25 cmH 2 O lumbar puncture opening pressure and active papilledema) were included. Participants received 400 mg of oral AZD4017 twice daily compared with matching placebo over 12 weeks. The outcome measures were initial efficacy, safety and tolerability. The primary clinical outcome was lumbar puncture opening pressure at 12 weeks analysed by intention-to-treat. Secondary clinical outcomes were symptoms, visual function, papilledema, headache and anthropometric measures.  In vivo  efficacy was evaluated in the central nervous system and systemically. A total of 31 subjects [mean age 31.2 (SD = 6.9) years and body mass index 39.2 (SD = 12.6) kg/m 2 ] were randomized to AZD4017 ( n  = 17) or placebo ( n  = 14). At 12 weeks, lumbar puncture pressure was lower in the AZD4017 group (29.7 cmH 2 O) compared with placebo (31.3 cmH 2 O), but the difference between groups was not statistically significant (mean difference: -2.8, 95% confidence interval: -7.1 to 1.5;  P  =   0.2). An exploratory analysis assessing mean change in lumbar puncture pressure within each group found a significant decrease in the AZD4017 group [mean change: -4.3 cmH 2 O (SD = 5.7);  P  =   0.009] but not in the placebo group [mean change: -0.3 cmH 2 O (SD = 5.9);  P  =   0.8]. AZD4017 was safe, with no withdrawals related to adverse effects. Nine transient drug-related adverse events were reported. One serious adverse event occurred in the placebo group (deterioration requiring shunt surgery).  In vivo  biomarkers of 11β-hydroxysteroid dehydrogenase type 1 activity (urinary glucocorticoid metabolites, hepatic prednisolone generation, serum and cerebrospinal fluid cortisol:cortisone ratios) demonstrated significant enzyme inhibition with the reduction in serum cortisol:cortisone ratio correlating significantly with reduction in lumbar puncture pressure ( P  = 0.005,  R  = 0.70). This is the first phase II randomized controlled trial in idiopathic intracranial hypertension evaluating a novel therapeutic target. AZD4017 was safe and well tolerated and inhibited 11β-hydroxysteroid dehydrogenase type 1 activity  in vivo . Reduction in serum cortisol:cortisone correlated with decreased intracranial pressure. Possible clinical benefits were noted in this small cohort. A longer, larger study would now be of interest.",2020,AZD4017 was safe and well tolerated and inhibited 11β-hydroxysteroid dehydrogenase type 1 activity  in vivo .,"['31 subjects [mean age 31.2 (SD\u2009=\u20096.9) years and body mass index 39.2 (SD\u2009=\u200912.6) kg/m 2 ', 'idiopathic intracranial hypertension', 'Women aged 18-55\u2009years with active idiopathic intracranial hypertension (>25 cmH 2 O lumbar puncture opening pressure and active papilledema']","['11β-hydroxysteroid dehydrogenase type 1 inhibitor AZD4017', 'AZD4017 or placebo', 'placebo', '400\u2009mg of oral AZD4017 twice daily compared with matching placebo', '11β-Hydroxysteroid dehydrogenase type 1 inhibition', 'AZD4017']","['11β-hydroxysteroid dehydrogenase type 1 activity (urinary glucocorticoid metabolites, hepatic prednisolone generation, serum and cerebrospinal fluid cortisol:cortisone ratios', 'lumbar puncture opening pressure at 12\u2009weeks analysed by intention-to-treat', 'intracranial pressure', 'therapeutic efficacy, safety and tolerability', 'symptoms, visual function, papilledema, headache and anthropometric measures', 'adverse effects', 'safe and well tolerated', 'serum cortisol:cortisone', 'initial efficacy, safety and tolerability', 'lumbar puncture pressure']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191319', 'cui_str': '31.2'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0033845', 'cui_str': 'Benign intracranial hypertension'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030353', 'cui_str': 'Optic papillitis'}]","[{'cui': 'C0020392', 'cui_str': 'Hydroxysteroid Dehydrogenases'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3501337', 'cui_str': 'AZD4017'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0020392', 'cui_str': 'Hydroxysteroid Dehydrogenases'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0030353', 'cui_str': 'Optic papillitis'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",31.0,0.497996,AZD4017 was safe and well tolerated and inhibited 11β-hydroxysteroid dehydrogenase type 1 activity  in vivo .,"[{'ForeName': 'Keira', 'Initials': 'K', 'LastName': 'Markey', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Botfield', 'Affiliation': 'Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Ottridge', 'Affiliation': 'Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Matthews', 'Affiliation': 'Birmingham Neuro-Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham B15 2WB, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Department of Neurology, The Walton Centre NHS Foundation Trust, Liverpool L9 7LJ, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Woolley', 'Affiliation': 'Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Connar', 'Initials': 'C', 'LastName': 'Westgate', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Yiangou', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Zerin', 'Initials': 'Z', 'LastName': 'Alimajstorovic', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Pushkar', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Institute of Neurological Sciences, Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow G51 4TF, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Rick', 'Affiliation': 'Nottingham Clinical Trials Unit, Queens Medical Centre, Nottingham NG7 2UH, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ives', 'Affiliation': 'Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Angela E', 'Initials': 'AE', 'LastName': 'Taylor', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Lorna C', 'Initials': 'LC', 'LastName': 'Gilligan', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Jenkinson', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Arlt', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Scotton', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Fairclough', 'Affiliation': 'Emerging Innovations Unit, Discovery Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge CB2 0SL, UK.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Singhal', 'Affiliation': 'Upper GI Unit and Minimally Invasive Unit, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham B9 5SS, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Stewart', 'Affiliation': 'Medical School, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Jeremy W', 'Initials': 'JW', 'LastName': 'Tomlinson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology & Metabolism (OCDEM), NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Headington, Oxford OX3 7LJ, UK.'}, {'ForeName': 'Gareth G', 'Initials': 'GG', 'LastName': 'Lavery', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Mollan', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham B15 2TT, UK.'}]",Brain communications,['10.1093/braincomms/fcz050']
2288,32954338,Intranasal oxytocin enhances approach-related EEG frontal alpha asymmetry during engagement of direct eye contact.,"The neuropeptide oxytocin is suggested to play a major role in a variety of complex human behaviours, including interpersonal bonding, trust and attachment. Recent theories have suggested that the role oxytocin plays in these complex social behaviours involves a modulation of motivational tendencies of approach-/avoidance-related behaviours. However, to date, direct neurophysiological evidence supporting this notion is limited. In this double-blind, randomized, placebo-controlled study with parallel design, we assessed the effects of administered intranasal oxytocin in 40 adult men on gaze behaviour and a neural marker of approach/avoidance motivational tendencies. Specifically, electroencephalography recordings were performed during the engagement of eye contact with a live model in a naturalistic two-person social context and electroencephalographic frontal alpha asymmetry, an established neurophysiological index of motivational tendencies for approach-/avoidance-related behaviours, was assessed. Compared to placebo, a single dose of oxytocin (24 international units) was shown to increase relative left-sided frontal asymmetry upon direct eye contact with a live model, which is indicative of an increase in approach-related motivational tendencies towards the presented eye contact stimulus. Notably, the treatment effect was most prominently observed in participants with lower self-reported social motivation (higher Motivation subscale scores on the Social Responsiveness Scale), indicating that participants with lower social motivation benefitted the most from the administered oxytocin. No treatment-specific changes were identified in terms of gaze behaviour towards the eye region of the live model. Together, these observations add neurophysiological evidence to the hypothesized role of oxytocin in modulating approach-/avoidance-related tendencies and suggest that inter-subject variability in person-dependent factors need to be considered to evaluate the potential benefit of intranasal oxytocin as a treatment. This notion is of particular relevance to the variety of neuropsychiatric populations such as autism spectrum disorder, social anxiety disorder and depression, for which intranasal oxytocin is increasingly considered a potential treatment.",2020,"Compared to placebo, a single dose of oxytocin (24 international units) was shown to increase relative left-sided frontal asymmetry upon direct eye contact with a live model, which is indicative of an increase in approach-related motivational tendencies towards the presented eye contact stimulus.",['40 adult men on gaze behaviour and a neural marker of approach/avoidance motivational tendencies'],"['intranasal oxytocin', 'oxytocin', 'placebo', 'neuropeptide oxytocin', 'Intranasal oxytocin']",['social motivation (higher Motivation subscale scores'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C4082107', 'cui_str': 'High motivation'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}]",40.0,0.165472,"Compared to placebo, a single dose of oxytocin (24 international units) was shown to increase relative left-sided frontal asymmetry upon direct eye contact with a live model, which is indicative of an increase in approach-related motivational tendencies towards the presented eye contact stimulus.","[{'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Soriano', 'Affiliation': 'Research Group for Neurorehabilitation, Department of Rehabilitation Sciences, KU Leuven, 3001 Leuven, Belgium.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Daniels', 'Affiliation': 'Research Group for Neurorehabilitation, Department of Rehabilitation Sciences, KU Leuven, 3001 Leuven, Belgium.'}, {'ForeName': 'Jellina', 'Initials': 'J', 'LastName': 'Prinsen', 'Affiliation': 'Research Group for Neurorehabilitation, Department of Rehabilitation Sciences, KU Leuven, 3001 Leuven, Belgium.'}, {'ForeName': 'Kaat', 'Initials': 'K', 'LastName': 'Alaerts', 'Affiliation': 'Research Group for Neurorehabilitation, Department of Rehabilitation Sciences, KU Leuven, 3001 Leuven, Belgium.'}]",Brain communications,['10.1093/braincomms/fcaa093']
2289,32957204,Evaluation of the implant stability and the marginal bone level changes during the first three months of dental implant healing process: A prospective clinical study.,"Achievement of adequate implant stability is one of the determinants for long-term successful osseointegration. Resonance frequency analysis was developed to monitor implant stability and is now a well-recognized, non-invasive tool for determining the appropriate time for functional loading. However, there have been few studies with continuous evaluation and comparison of implant stability and marginal bone level changes between two different macro designs and clinical situations during the implant healing process. Thus, the purpose of this clinical trial is to evaluate the implant stability and marginal bone level changes of straight and conical implants during the implant healing process. In this prospective clinical trial, 25 participants were randomized to either straight or conical implants. A total of 32 titanium dental implants with a length of 9 mm or 11 mm were installed in the maxilla and the mandible according to the manufacturer's instructions. A resonance frequency analyzer was used to measure the implant stability quotient (ISQ) at the time of implant placement and after 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 weeks of healing. The changes in the peri-implant marginal bone level were evaluated from digital radiographic films taken at the time of implant placement and after 4 weeks, 8 weeks, and 12 weeks of healing. The preliminary results of this study revealed higher ISQ values and better healing tendency for conical implants in comparison with straight implants in the maxilla. Similar ISQ values and healing tendency were observed for straight and conical implants in the mandible. No significant differences in marginal bone loss were found between the straight and conical implants. However, in the mandible, slightly more marginal bone loss was found with the conical implants than straight implants after 12 weeks of healing. In conclusion, ISQ healing tendency and marginal bone loss are influenced by implant macro-design and jaw regions. Straight implants revealed similar ISQ healing tendency and marginal bone loss in both the mandible and maxilla. Conical implants were confirmed more beneficial for maintenance of implant stability and marginal bone level in the maxilla.",2020,"However, in the mandible, slightly more marginal bone loss was found with the conical implants than straight implants after 12 weeks of healing.","[""32 titanium dental implants with a length of 9\xa0mm or 11\xa0mm were installed in the maxilla and the mandible according to the manufacturer's instructions"", '25 participants']",['straight or conical implants'],"['implant stability and marginal bone level', 'ISQ values', 'healing tendency', 'Similar ISQ values and healing tendency', 'marginal bone loss', 'implant stability quotient (ISQ', 'ISQ healing tendency and marginal bone loss', 'peri-implant marginal bone level']","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0347985', 'cui_str': 'During values'}]",25.0,0.0429769,"However, in the mandible, slightly more marginal bone loss was found with the conical implants than straight implants after 12 weeks of healing.","[{'ForeName': 'Yi-Han', 'Initials': 'YH', 'LastName': 'Su', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Division of Prosthodontics, Department of Dentistry, Taipei Medical University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Bou-Yue', 'Initials': 'BY', 'LastName': 'Peng', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Peter-D', 'Initials': 'PD', 'LastName': 'Wang', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Department of Periodontics, College of Dental Medicine, Columbia University, New York, USA.'}, {'ForeName': 'Sheng-Wei', 'Initials': 'SW', 'LastName': 'Feng', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Division of Prosthodontics, Department of Dentistry, Taipei Medical University Hospital, Taipei, Taiwan. Electronic address: shengwei@tmu.edu.tw.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103899']
2290,32957209,Accelerated loading frequency does not influence the fatigue behavior of polymer infiltrated ceramic network or lithium disilicate glass-ceramic restorations.,"This study aimed to evaluate the influence of loading frequency on the fatigue mechanical behavior of adhesively cemented polymer-infiltrated ceramic-network (PICN) and lithium disilicate (LD) simplified monolithic restorations. Thirty (30) disc-shaped specimens (Ø = 10 mm; thickness = 1.0 mm) of each ceramic material (PICN - Enamic, Vita Zahnfabrik or LD - IPS e.max CAD, Ivoclar Vivadent) were produced and adhesively cemented onto dentin analogue discs made of fiber and epoxy resin material (Ø = 10 mm; thickness = 2.0 mm). PICN and LD cemented assemblies were randomly allocated into 2 groups (n = 15) according to the loading frequency used for the fatigue testing (20 Hz or 2 Hz), composing the PICN_20, PICN_2, LD_20 and LD_2 testing groups. Fatigue tests were run using the step-stress approach (initial load = 200 N; step-size = 100 N; 10,000 cycles per step) and the collected data (fatigue failure load - FFL and number of cycles for failure - CFF) were analyzed by survival tests (Kaplan Meier and Mantel-Cox) and Weibull analysis. Fractographic analysis of failed specimens were also performed. No statistically significant differences were detected in relation to FFL and CFF between the groups within the same ceramic material (PICN_20: 1127 N/102,667 cycles = PICN_2: 1120 N/102,000 cycles; LD_20: 980 N/88,000 cycles = LD_2: 900 N/80,000 cycles). All failures were radial cracks in the cementation surface. Therefore, the use of a 20 Hz loading frequency shows to be a viable alternative to accelerate cyclic fatigue tests without affecting the fatigue mechanical behavior and the failure pattern of simplified restorations made of lithium disilicate glass ceramic or polymer infiltrated ceramic network bonded to the dentin analogue.",2020,"No statistically significant differences were detected in relation to FFL and CFF between the groups within the same ceramic material (PICN_20: 1127 N/102,667 cycles = PICN_2: 1120 N/102,000 cycles; LD_20: 980 N/88,000 cycles = LD_2: 900 N/80,000 cycles).","['PICN and LD cemented assemblies', 'Thirty (30) disc-shaped specimens (Ø =\xa010\xa0mm; thickness =\xa01.0\xa0mm) of each ceramic material (PICN - Enamic, Vita Zahnfabrik or LD - IPS e.max CAD, Ivoclar Vivadent) were produced and adhesively cemented onto dentin analogue discs made of fiber and epoxy resin material (Ø =\xa010\xa0mm; thickness =\xa02.0\xa0mm']",['adhesively cemented polymer-infiltrated ceramic-network (PICN) and lithium disilicate (LD) simplified monolithic restorations'],"['Fatigue tests', 'relation to FFL and CFF']","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C4308553', 'cui_str': 'ENAMIC'}, {'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0124269', 'cui_str': 'Ivoclar'}, {'cui': 'C0148539', 'cui_str': 'Vivadent'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0014631', 'cui_str': 'Epoxy resin'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0333511,"No statistically significant differences were detected in relation to FFL and CFF between the groups within the same ceramic material (PICN_20: 1127 N/102,667 cycles = PICN_2: 1120 N/102,000 cycles; LD_20: 980 N/88,000 cycles = LD_2: 900 N/80,000 cycles).","[{'ForeName': 'Helder Callegaro', 'Initials': 'HC', 'LastName': 'Velho', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: heldercvelho@hotmail.com.'}, {'ForeName': 'Kiara Serafini', 'Initials': 'KS', 'LastName': 'Dapieve', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: kiara_s_d@hotmail.com.'}, {'ForeName': 'Gabriel Kalil', 'Initials': 'GK', 'LastName': 'Rocha Pereira', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fraga', 'Affiliation': 'Department of Conservative Dentistry, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul State, Brazil. Electronic address: sara.odonto@yahoo.com.br.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}, {'ForeName': 'Andressa Borin', 'Initials': 'AB', 'LastName': 'Venturini', 'Affiliation': 'MSciD and PhD Post-Graduate Program in Oral Science, Faculty of Dentistry, Federal University of Santa Maria (UFSM), Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: andressa.venturini@hotmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103905']
2291,32957242,Influence of Deep Margin Elevation and preparation design on the fracture strength of indirectly restored molars.,"The objectives of this in-vitro study were to investigate the influence of Deep Margin Elevation (DME) and the preparation design (cusp coverage) on the fracture strength and repairability of CAD/CAM manufactured lithium disilicate (LS 2 ) restorations on molars. Sound extracted human molars (n = 60) were randomly divided into 4 groups (n = 15) (inlay without DME (InoD); inlay with DME (IWD); onlay without DME (OnoD); onlay with DME (OnWD)). All samples were aged (1.2 × 10 6  cycles of 50N, 8000 cycles of 5-55 °C) followed by oblique static loading until fracture. Fracture strength was measured in Newton and the fracture analysis was performed using a (scanning electron) microscope. Data was statistically analyzed using two-way ANOVA and contingency tables. DME did not affect the fracture strength of LS 2  restorations to a statistically significant level (p = .15). Onlays were stronger compared to inlays (p = .00). DME and preparation design did not interact (p = .97). However, onlays with DME were significantly stronger than inlays without DME (p = .00). More repairable fractures were observed among inlays (p = .00). Catastrophic, crown-root fractures were more prevalent in onlays (p = .00). DME did not influence repairability of fractures or fracture types to a statistically significant level (p > .05). Within the limitations of this in-vitro study, DME did not statistical significantly affect the fracture strength, nor the fracture type or repairability of LS 2  restorations in molars. Cusp coverage did increase the fracture strength. However, oblique forces necessary to fracture both inlays and onlays, either with or without DME, by far exceeded the bite forces that can be expected under physiological clinical conditions. Hence, both inlays and onlays are likely to be fracture resistant during clinical service.",2020,DME did not influence repairability of fractures or fracture types to a statistically significant level (p > .05).,"['All samples were aged (1.2\xa0×\xa010 6  cycles of 50N, 8000 cycles of 5-55\xa0°C) followed by oblique static loading until fracture', 'CAD/CAM manufactured lithium disilicate (LS 2 ) restorations on molars', 'Sound extracted human molars (n\xa0=\xa060']","['15) (inlay without DME (InoD); inlay with DME (IWD); onlay without DME (OnoD); onlay with DME (OnWD', 'DME']","['repairable fractures', 'fracture strength of indirectly restored molars', 'Deep Margin Elevation (DME', 'Catastrophic, crown-root fractures', 'Fracture strength', 'fracture strength']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C3840857', 'cui_str': '8000'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0058217', 'cui_str': 'dimethyl ether'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}]",60.0,0.0204494,DME did not influence repairability of fractures or fracture types to a statistically significant level (p > .05).,"[{'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Bresser', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, Groningen, the Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'van de Geer', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, Groningen, the Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gerdolle', 'Affiliation': 'Private Practice, Montreux, Switzerland.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Schepke', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, Groningen, the Netherlands.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Cune', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, Groningen, the Netherlands; St. Antonius Hospital, Department of Oral Maxillofacial Surgery, Prosthodontics and Special Dental Care, Nieuwegein, the Netherlands; University of Utrecht, University Medical Center Utrecht, Department of Oral Maxillofacial Surgery, Prosthodontics and Special Dental Care, Utrecht, the Netherlands.'}, {'ForeName': 'M M M', 'Initials': 'MMM', 'LastName': 'Gresnigt', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Center for Dentistry and Oral Hygiene, Department of Restorative Dentistry and Biomaterials, Groningen, the Netherlands; Martini Hospital, Department of Special Dental Care, Groningen, the Netherlands. Electronic address: marcogresnigt@yahoo.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103950']
2292,32957253,Fatigue performance of fully-stabilized zirconia polycrystals monolithic restorations: The effects of surface treatments at the bonding surface.,"This study evaluated the distinct conditioning effect of the intaglio surface of bonded fully-stabilized zirconia (FSZ) simplified restorations on the mechanical fatigue behavior of the set prior to and after aging. Ceramic disc shaped specimens (Ø= 10 mm and 1 mm thick) were randomly allocated into 14 groups considering: ""surface treatments"" (Ctrl: no-treatment; PM: universal primer; GLZ: low-fusing porcelain glaze; SNF: 5 nm SiO 2  nanofilm deposition; AlOx: air-abrasion with aluminum oxide; SiC: air-abrasion with silica-coated aluminum oxide; 7%Si: air-abrasion with 7% silica-coated aluminum oxide); and ""aging"" (baseline: 24 h at 37 °C in water; or aged: 90 days at 37 °C in water + 12,000 thermal cycles). The discs were treated, luted with resin cement onto the dentin analog, subjected to aging or not, and then tested under a step-stress fatigue test at 20 Hz, 10,000 cycles/step, step-size of 100N starting at 200N, and proceeding until failure detection. Fractographic, topographic, surface roughness, contact angle, and atomic force microscopy analyzes were performed. The surface treatments at baseline led to statistically similar fatigue failure loads (953N-1313N), except for GLZ (1313N), which was significantly higher than 7%Si (953 N). Meanwhile, Ctrl had 40% pre-test failures (debonding) after aging, and therefore the worst fatigue performance (notable decrease in fatigue results), while all the other groups presented superior and statistically similar fatigue behavior (973-1271N). In fact, when considering baseline Vs aging conditions, stable fatigue results could only be noted when using surface treatments. In conclusion, internal surface treatments of FSZ ceramic restorations are mandatory for fatigue behavior stability after aging the restorative set, while non-treatment induced unstable results.",2020,"The surface treatments at baseline led to statistically similar fatigue failure loads (953N-1313N), except for GLZ (1313N), which was significantly higher than 7%Si (953 N).","['fully-stabilized zirconia polycrystals monolithic restorations', 'Ceramic disc shaped specimens (Ø= 10\xa0mm and 1\xa0mm thick']","['surface treatments"" (Ctrl: no-treatment; PM: universal primer; GLZ: low-fusing porcelain glaze; SNF: 5\xa0nm SiO 2  nanofilm deposition; AlOx: air-abrasion with aluminum oxide; SiC: air-abrasion with silica-coated aluminum oxide; 7%Si: air-abrasion with 7% silica-coated aluminum oxide); and ""aging"" (baseline: 24\xa0h at 37\xa0°C in water; or aged: 90 days at 37\xa0°C in water\xa0+\xa012,000 thermal cycles', 'FSZ ceramic restorations', 'bonded fully-stabilized zirconia (FSZ) simplified restorations']","['Fractographic, topographic, surface roughness, contact angle, and atomic force microscopy analyzes', 'worst fatigue performance', 'mechanical fatigue behavior', 'Fatigue performance', 'fatigue behavior', 'fatigue behavior stability']","[{'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0206415', 'cui_str': 'Oligonucleotide Primers'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011392', 'cui_str': 'Dental porcelain material'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0002374', 'cui_str': 'Aluminum Oxide'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0242849', 'cui_str': 'Atomic Force Microscopy'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0285306,"The surface treatments at baseline led to statistically similar fatigue failure loads (953N-1313N), except for GLZ (1313N), which was significantly higher than 7%Si (953 N).","[{'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Cadore-Rodrigues', 'Affiliation': 'Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: anacadorerodrigues@gmail.com.'}, {'ForeName': 'Pablo Soares', 'Initials': 'PS', 'LastName': 'Machado', 'Affiliation': 'Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: P17_SM@hotmail.com.'}, {'ForeName': 'Jivago Schumacher de', 'Initials': 'JS', 'LastName': 'Oliveira', 'Affiliation': 'Chemical Engineering, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: jivago.s.o@hotmail.com.'}, {'ForeName': 'Sérgio Luiz', 'Initials': 'SL', 'LastName': 'Jahn', 'Affiliation': 'Chemical Engineering, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: sergiojahn@gmail.com.'}, {'ForeName': 'Gustavo Luiz', 'Initials': 'GL', 'LastName': 'Callegari', 'Affiliation': 'Physics Department, Federal University of Santa Maria, Santa Maria, Brazil. Electronic address: glcallegari@gmail.com.'}, {'ForeName': 'Lucio Strazzabosco', 'Initials': 'LS', 'LastName': 'Dorneles', 'Affiliation': 'Physics Department, Federal University of Santa Maria, Santa Maria, Brazil. Electronic address: lsdorneles@gmail.com.'}, {'ForeName': 'Thiago Augusto de Lima', 'Initials': 'TAL', 'LastName': 'Burgo', 'Affiliation': 'Physics Department, Federal University of Santa Maria, Santa Maria, Brazil. Electronic address: burgounicamp@gmail.com.'}, {'ForeName': 'Marilia Pivetta', 'Initials': 'MP', 'LastName': 'Rippe', 'Affiliation': 'Post-Graduate Program in Oral Science, Prosthodontic Unit, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: mariliarip@hotmail.com.'}, {'ForeName': 'Gabriel Kalil', 'Initials': 'GK', 'LastName': 'Rocha Pereira', 'Affiliation': 'Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: gabrielkrpereira@hotmail.com.'}, {'ForeName': 'Luiz Felipe', 'Initials': 'LF', 'LastName': 'Valandro', 'Affiliation': 'Oral Science, Federal University of Santa Maria, Santa Maria, Rio Grande do Sul State, Brazil. Electronic address: valandrolf@gmail.com.'}]",Journal of the mechanical behavior of biomedical materials,['10.1016/j.jmbbm.2020.103962']
2293,32957340,Analgesic effects of low-dose ketamine after spinal fusion in adults: A protocol of prospective randomized trial.,"BACKGROUND


Patients with spinal fusion often have opioid tolerance and chronic pain, which makes it difficult to control postoperative pain. In this double-blind, randomized, prospective study, we assessed the safety and efficacy of intravenous low-dose ketamine for the treatment of pain in patients undergoing the lumbar spinal fusion.
METHODS


This randomized, prospective, double-blind and placebo-controlled study was approved via the hospital institutional review committee. Patients were registered with signed written consent. All the floor nurses, recovery room and surgeons, patients, statisticians as well as research assistants were unaware of the grouping. The patients were randomly divided into ketamine group and control group by random number table. Nausea, vomiting or vomiting, the intensity of pain, adverse events, cumulative morphine consumption, as well as the amount of extra antiemetics or analgesics were evaluated at 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after the operation. P < .05 was considered to be the statistically significant. The Statistical Package for the software of Social Sciences 20.0 was utilized for statistical analysis.
CONCLUSIONS


For the present trial, we assumed that intravenous ketamine could improve the satisfaction of patient by reducing the total consumption of morphine equivalent and the pain scores.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5896).",2020,"Nausea, vomiting or vomiting, the intensity of pain, adverse events, cumulative morphine consumption, as well as the amount of extra antiemetics or analgesics were evaluated at 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after the operation.","['patients undergoing the lumbar spinal fusion', 'adults']","['low-dose ketamine', 'placebo', 'intravenous low-dose ketamine', 'ketamine']","['Analgesic effects', 'safety and efficacy', 'Nausea, vomiting or vomiting, the intensity of pain, adverse events, cumulative morphine consumption, as well as the amount of extra antiemetics or analgesics', 'total consumption of morphine equivalent and the pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.297415,"Nausea, vomiting or vomiting, the intensity of pain, adverse events, cumulative morphine consumption, as well as the amount of extra antiemetics or analgesics were evaluated at 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after the operation.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Handan Central Hospital, Hebei Province, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Yongxue', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022162']
2294,32957353,Observation for the effect of rTMS combined with magnetic stimulation at Neiguan (PC6) and Sanyinjiao (SP6) points on limb function after stroke: A study protocol.,"BACKGROUND


Stroke is the primary cause of adult disability in China, which causes serious personal, family, and social burden. ""Central peripheral central"" closed-loop rehabilitation theory is proved to be an effective neural rehabilitation model. Based on this theory, repetitive transcranial magnetic stimulation (rTMS) combined with magnetic stimulation of Neiguan (PC6) and Sanyinjiao (SP6) may be an effective treatment for limb dysfunction after stroke. However, the efficacy and mechanism of repetitive magnetic stimulation of M1 region combined with magnetic stimulation of Neiguan and Sanyinjiao points on limb dysfunction after stroke has not been confirmed.
METHODS/DESIGN


This study is a prospective, randomized, controlled, open trial. We randomly divided 42 subjects, aged 35 to 80 years, diagnosed with ischemic stroke within 1 month, into 2 groups with a ratio of 1:1. On the basis of this medical treatment, patients in the experimental group received 1 Hz rTMS in M1 area on the contralateral side, and 3 Hz rTMS treatment at Neiguan point and Sanyinjiao point on the affected side. The control group was treated with acupuncture (body acupuncture). All patients were treated once a day and followed up for 10 days. The National Institute of Health Stroke Scale score, simplified fulg Meyer, modified Barthel index, and cortical excitability were evaluated on the day of enrollment and the 10th day of treatment respectively. The modified Barthe index was followed up on the 30th day of treatment, and the adverse reactions were recorded at any time. The mechanism of rTMS will be revealed by Barthe index before treatment, on the 10th day of treatment and on the 30th day of follow-up. The results were analyzed by spss19.0 software, and the quantitative indexes were analyzed by t test and rank sum test. χ test was used for non-grade counting, and rank sum test was used for grade counting. All statistical tests were performed with bilateral test. If P value is less than or equal to .05, the difference will be considered statistically significant.
CONCLUSION


The purpose of this study was to determine the effect of repetitive magnetic stimulation of M1 region combined with magnetic stimulation of Neiguan and Sanyinjiao points on limb function after stroke. Through this study, we expect to explore a new scheme for the treatment of poststroke dyskinesia, and prove that compared with rTMS and acupuncture alone, the closed-loop rehabilitation theory based on ""center peripheral center"" can be more efficient and safe in the treatment of poststroke limb dysfunction.
TRIAL REGISTRATION


The trial was registered in China clinical trial registry (http://www.chictr.org.cn/index.aspx), ID: ChiCTR1900026890 (October 25, 2019).",2020,"The National Institute of Health Stroke Scale score, simplified fulg Meyer, modified Barthel index, and cortical excitability were evaluated on the day of enrollment and the 10th day of treatment respectively.","['limb function after stroke', '42 subjects, aged 35 to 80 years, diagnosed with ischemic stroke within 1 month, into 2 groups with a ratio of 1:1']","['M1 region combined with magnetic stimulation of Neiguan and Sanyinjiao points', 'rTMS and acupuncture', '1\u200aHz rTMS', 'acupuncture (body acupuncture', 'rTMS combined with magnetic stimulation at Neiguan (PC6) and Sanyinjiao (SP6) points', 'repetitive transcranial magnetic stimulation (rTMS) combined with magnetic stimulation of Neiguan (PC6) and Sanyinjiao (SP6']","['adverse reactions', 'limb function', 'National Institute of Health Stroke Scale score, simplified fulg Meyer, modified Barthel index, and cortical excitability', 'limb dysfunction']","[{'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0450548', 'cui_str': 'SP6'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",,0.0451603,"The National Institute of Health Stroke Scale score, simplified fulg Meyer, modified Barthel index, and cortical excitability were evaluated on the day of enrollment and the 10th day of treatment respectively.","[{'ForeName': 'Penglong', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Zucheng', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Dongling', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'Department of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000022207']
2295,32957356,The efficacy of nursing intervention to reduce preoperative anxiety in patients with total knee arthroplasty: A protocol of prospective randomized trial.,"BACKGROUND


Some patients undergoing the total knee arthroplasty (TKA) have suboptimal postoperative results, and preoperative anxiety may be one of the reasons for these unsatisfactory results. We perform this randomized control study protocol to determine the effectiveness of nursing intervention, on the basis of motivational interview, to decrease the preoperative anxiety in patients receiving TKA.
METHODS


This is a double-blinded, single-center, placebo-controlled and randomized trial, which will be conducted from December 2020 to June 2021. The protocol of this study was approved by the West China Hospital of Sichuan University (W20200803-28). Sixty patients who will undergo TKA are included in our study. Patients are randomly divided into experiential group (with 30 patients) and the control group (with 30 patients). The control group and experimental group receive an informative and separate session via nursing about the operation preparation and operation process. Both the control group and the experimental group are given habitual treatment, but the experimental group need to receive additional motivational interviews. The primary outcomes are the Hospital Anxiety and Depression Scale and the Amsterdam Preoperative Anxiety and Information Scale. Secondary outcome is postoperative pain, which is assessed by visual analogue scale .
RESULTS


Figure 1 will display the comparison of preoperative and postoperative total average anxiety scores in control group and the experimental group.
CONCLUSION


Preoperative psychological distress is familiar in our patients. We hypothesized that nursing intervention may be associated with reduced preoperative anxiety in the patients receiving TKA.",2020,The primary outcomes are the Hospital Anxiety and Depression Scale and the Amsterdam Preoperative Anxiety and Information Scale.,"['December 2020 to June 2021', 'patients receiving TKA', 'patients with total knee arthroplasty', 'West China Hospital of Sichuan University (W20200803-28', 'patients undergoing the total knee arthroplasty (TKA', 'Sixty patients who will undergo TKA are included in our study']","['placebo', 'informative and separate session via nursing about the operation preparation and operation process', 'nursing intervention']","['postoperative pain, which is assessed by visual analogue scale ', 'preoperative and postoperative total average anxiety scores', 'preoperative anxiety', 'Hospital Anxiety and Depression Scale and the Amsterdam Preoperative Anxiety and Information Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0515531,The primary outcomes are the Hospital Anxiety and Depression Scale and the Amsterdam Preoperative Anxiety and Information Scale.,"[{'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Neurological Comprehensive Ward.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics.'}, {'ForeName': 'Chaofeng', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'Department of Neurological Comprehensive Ward.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Nursing, West China Hospital of Sichuan University/West China Nursing College, Sichuan, China.'}]",Medicine,['10.1097/MD.0000000000022213']
2296,32957394,Fluid Management in Patients with Acute Respiratory Distress Syndrome and Diabetes Mellitus: A propensity score matched analysis of the fluid and catheter treatment trial.,"Diabetes mellitus results in an attenuated inflammatory response, reduces pulmonary microvascular permeability, and may decrease the risk of developing acute respiratory distress syndrome (ARDS). Studies have shown that patients with ARDS are better managed by a conservative as compared to liberal fluid management strategy. However, it is not known if the same fluid management principles hold true for patients with comorbid diabetes mellitus and ARDS.As diabetes mellitus results in reduced pulmonary microvascular permeability and an attenuated inflammatory response, we hypothesize that in the setting of ARDS, diabetic patients will be able to tolerate a positive fluid balance better than patients without diabetes.The Fluid and Catheter Treatment Trial (FACTT) randomized patients with ARDS to conservative versus liberal fluid management strategies. In a secondary analysis of this trial, we calculated the interaction of diabetic status and differing fluid strategies on outcomes. Propensity score subclassification matching was used to control for the differing baseline characteristics between patients with and without diabetes.Nine hundred fifty-six patients were analyzed. In a propensity score matched analysis, the difference in the effect of a conservative as compared to liberal fluid management strategy on ventilator free days was 2.23 days (95% CI: -0.97 to 5.43 days) in diabetic patients, and 2.37 days (95% CI: -0.21 to 4.95 days) in non-diabetic patients. The difference in the effect of a conservative as compared to liberal fluid management on 60 day mortality was 2% (95% CI: -11.8% to 15.8%) in diabetic patients, and -7.9% (95% CI: -21.7% to 5.9%) in non-diabetic patients.When comparing a conservative fluid management strategy to a liberal fluid management strategy, diabetic patients with ARDS did not have a statistically significant difference in outcomes than non-diabetic patients.",2020,"Diabetes mellitus results in an attenuated inflammatory response, reduces pulmonary microvascular permeability, and may decrease the risk of developing acute respiratory distress syndrome (ARDS).","['Nine hundred fifty-six patients were analyzed', 'Mellitus', 'Patients with Acute Respiratory Distress Syndrome and Diabetes', 'patients with ARDS', 'patients with comorbid diabetes mellitus and ARDS.As diabetes mellitus', 'diabetic patients with ARDS']",['Fluid Management'],['pulmonary microvascular permeability'],"[{'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0748355', 'cui_str': 'Acute respiratory distress'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0162336', 'cui_str': 'Microvascular Permeability'}]",,0.201232,"Diabetes mellitus results in an attenuated inflammatory response, reduces pulmonary microvascular permeability, and may decrease the risk of developing acute respiratory distress syndrome (ARDS).","[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Achanta', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hayden', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital.'}, {'ForeName': 'Boyd Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital.'}]",Medicine,['10.1097/MD.0000000000022311']
2297,32955177,Osimertinib in Resected  EGFR -Mutated Non-Small-Cell Lung Cancer.,"BACKGROUND


Osimertinib is standard-of-care therapy for previously untreated epidermal growth factor receptor ( EGFR ) mutation-positive advanced non-small-cell lung cancer (NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown.
METHODS


In this double-blind, phase 3 trial, we randomly assigned patients with completely resected  EGFR  mutation-positive NSCLC in a 1:1 ratio to receive either osimertinib (80 mg once daily) or placebo for 3 years. The primary end point was disease-free survival among patients with stage II to IIIA disease (according to investigator assessment). The secondary end points included disease-free survival in the overall population of patients with stage IB to IIIA disease, overall survival, and safety.
RESULTS


A total of 682 patients underwent randomization (339 to the osimertinib group and 343 to the placebo group). At 24 months, 90% of the patients with stage II to IIIA disease in the osimertinib group (95% confidence interval [CI], 84 to 93) and 44% of those in the placebo group (95% CI, 37 to 51) were alive and disease-free (overall hazard ratio for disease recurrence or death, 0.17; 99.06% CI, 0.11 to 0.26; P<0.001). In the overall population, 89% of the patients in the osimertinib group (95% CI, 85 to 92) and 52% of those in the placebo group (95% CI, 46 to 58) were alive and disease-free at 24 months (overall hazard ratio for disease recurrence or death, 0.20; 99.12% CI, 0.14 to 0.30; P<0.001). At 24 months, 98% of the patients in the osimertinib group (95% CI, 95 to 99) and 85% of those in the placebo group (95% CI, 80 to 89) were alive and did not have central nervous system disease (overall hazard ratio for disease recurrence or death, 0.18; 95% CI, 0.10 to 0.33). Overall survival data were immature; 29 patients died (9 in the osimertinib group and 20 in the placebo group). No new safety concerns were noted.
CONCLUSIONS


In patients with stage IB to IIIA  EGFR  mutation-positive NSCLC, disease-free survival was significantly longer among those who received osimertinib than among those who received placebo. (Funded by AstraZeneca; ADAURA ClinicalTrials.gov number, NCT02511106.).",2020,"At 24 months, 90% of the patients with stage II to IIIA disease in the osimertinib group (95% confidence interval [CI], 84 to 93) and 44% of those in the placebo group (95% CI, 37 to 51) were alive and disease-free (overall hazard ratio for disease recurrence or death, 0.17; 99.06% CI, 0.11 to 0.26; P<0.001).","['682 patients underwent randomization (339 to the osimertinib group and 343 to the placebo group', 'randomly assigned patients with completely resected  EGFR  mutation-positive NSCLC in a 1:1 ratio to receive either']","['placebo', 'osimertinib (80 mg once daily) or placebo']","['efficacy and safety', 'alive and disease-free (overall hazard ratio for disease recurrence or death', 'disease-free survival', 'alive and disease-free', 'central nervous system disease', 'Overall survival data', 'overall survival, and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",682.0,0.762947,"At 24 months, 90% of the patients with stage II to IIIA disease in the osimertinib group (95% confidence interval [CI], 84 to 93) and 44% of those in the placebo group (95% CI, 37 to 51) were alive and disease-free (overall hazard ratio for disease recurrence or death, 0.17; 99.06% CI, 0.11 to 0.26; P<0.001).","[{'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'John', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grohe', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Goldman', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Laktionov', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Huu-Vinh', 'Initials': 'HV', 'LastName': 'Vu', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Kye-Young', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Charuwan', 'Initials': 'C', 'LastName': 'Akewanlop', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Chong-Jen', 'Initials': 'CJ', 'LastName': 'Yu', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Marinis', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bonanno', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domine', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Lingmin', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hodge', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Ajlan', 'Initials': 'A', 'LastName': 'Atasoy', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Rukazenkov', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': ""From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangzhou (Y.-L.W.), the Thoracic Surgery Department, National Cancer Center-National Clinical Research Center for Cancer-Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.H.), and the Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.) - all in China; the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), and the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Department of Medical Oncology, Austin Health, Melbourne, VIC, Australia (T.J.); the Department of Respiratory Diseases, Evangelische Lungenklinik, Berlin (C.G.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and the Department of Oncology, Hospital Universitario Fundación Jiménez Díaz, Madrid (M.D.); the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.W.G.); the Center of Innovative Technologies and Oncology, N.N. Blokhin Russian Cancer Center, Russian Academy of Medical Sciences, Moscow (K.L.); the Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine (S.-W.K.), and the Precision Medicine Lung Cancer Center, Konkuk University Medical Center (K.-Y.L.) - both in Seoul, South Korea; the Department of Thoracic Surgery, Cho Ray Hospital, Ho Chi Minh City, Vietnam (H.-V.V.); the Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand (C.A.); the Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan (C.-J.Y.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.), and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua (L.B.) - both in Italy; the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre and the University of Toronto, Toronto (F.A.S.); Late Oncology Statistics, AstraZeneca, Gaithersburg, MD (L.Z.); Late Oncology Statistics (R.H.) and Oncology Research and Development (A.A., Y.R.), AstraZeneca, Cambridge, United Kingdom; and Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2027071']
2298,32955200,"Safety, Tolerability, and Physiological Effects of AXA1665, a Novel Composition of Amino Acids, in Subjects With Child-Pugh A and B Cirrhosis.","INTRODUCTION


AXA1665 is a novel investigational amino acid (AA) composition specifically designed to impact AA imbalance, ammoniagenesis, and dysregulated anabolic activity associated with cirrhosis.
METHODS


This 2-part study examined AXA1665 effects on safety, tolerability, and hepatic/muscle physiology in subjects with Child-Pugh A and B cirrhosis. Part 1 established plasma ammonia and AA concentration baselines with a standardized protein supplement. Part 2 included two 15-day domiciled periods separated by a 14-day washout. In period 1, subjects were randomly distributed to 2 groups: AXA1665 14.7 g t.i.d. (group 1) or control t.i.d. (group 2). In period 2, subjects from group 1 crossed over to control and those in group 2 crossed over to AXA1665 4.9 g t.i.d. All subjects were maintained on standard of care (standardized meals; 30-minute daily, supervised, mandatory physical activity; and daily late-evening snack).
RESULTS


In parts 1 and 2, 23 and 17 participants were enrolled, respectively. Dose-dependent increases were observed in plasma concentrations of AXA1665-constituent AAs. Fasted branched-chain AA-to-aromatic AA and valine-to-phenylalanine ratios were both increased (AXA1665 14.7 g t.i.d. control-adjusted change: 44.3% ± 2.7% and 47.2% ± 3.9%, respectively; P < 0.0001). Despite provision of additional nitrogen, mean fasted plasma ammonia concentration at day 15 numerically decreased (-21.1% in AXA1665 14.7 g t.i.d. vs -3.8% in control; P > 0.05). AXA1665 14.7 g t.i.d. produced a leaner body composition and significantly decreased Liver Frailty Index at day 15 vs control (-0.70 ± 0.15 vs -0.14 ± 0.17; P < 0.05). AXA1665 was safe and well tolerated.
DISCUSSION


AXA1665 has potential to mitigate core metabolic derangements associated with cirrhosis.",2020,"Despite provision of additional nitrogen, mean fasted plasma ammonia concentration at day 15 numerically decreased (-21.1% in AXA1665 14.7 g t.i.d.","['subjects with Child-Pugh A and B cirrhosis', 'Subjects With Child-Pugh A and B Cirrhosis', 'In parts 1 and 2, 23 and 17 participants were enrolled, respectively']","['AXA1665 14.7 g t.i.d', 'AXA1665', 'AXA1665 4.9 g t.i.d']","['Liver Frailty Index', 'plasma concentrations of AXA1665-constituent AAs', 'safety, tolerability, and hepatic/muscle physiology', 'safe and well tolerated', 'leaner body composition', 'Safety, Tolerability', 'mean fasted plasma ammonia concentration']","[{'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0449719', 'cui_str': 'Part'}]",[],"[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0729650', 'cui_str': 'Constituents'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1278131', 'cui_str': 'Plasma ammonia measurement'}]",,0.0297791,"Despite provision of additional nitrogen, mean fasted plasma ammonia concentration at day 15 numerically decreased (-21.1% in AXA1665 14.7 g t.i.d.","[{'ForeName': 'Manu V', 'Initials': 'MV', 'LastName': 'Chakravarthy', 'Affiliation': '1Axcella Health Inc., Cambridge, Massachusetts, USA; 2Orange County Research Center, Tustin, California, USA; 3Flagship Pioneering, Cambridge, Massachusetts, USA; 4Division of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Neutel', 'Affiliation': ''}, {'ForeName': 'Scharmen', 'Initials': 'S', 'LastName': 'Confer', 'Affiliation': ''}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Tatsuta', 'Affiliation': ''}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Rebello', 'Affiliation': ''}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Comb', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hamill', 'Affiliation': ''}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Tramontin', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Carroll', 'Affiliation': ''}, {'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Afeyan', 'Affiliation': ''}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000222']
2299,32955273,Promoting resilience: A preschool intervention enhances the adolescent adjustment of children exposed to early adversity.,"Two hundred ninety-four children from low-income families (58% White, 17% Latinx, 25% Black; 54% girls; Mage = 4.49 years old at study entry) were recruited from Head Start classrooms to participate in a randomized-controlled trial of the project Research-based, Developmentally Informed (REDI) preschool intervention and then followed longitudinally for 10 years through 9th grade. At study entry, parents reported on their children's exposure to adverse childhood experiences (ACEs). Youth reported on their feelings of social-emotional distress and school bonding after making the transition into middle school (7th grade) and high school (9th grade). Multilevel latent profile analyses revealed three profiles of adolescent distress and school bonding. Increased rates of ACEs in early childhood predicted membership in adolescent profiles characterized by heightened social-emotional distress and reduced levels of school bonding. The REDI intervention that focused on promoting early social-emotional and language skills in preschool moderated the impact of early ACEs on adolescent adjustment and promoted youth resilience, significantly buffering children from the negative impact of early ACEs on their levels of social-emotional distress and school bonding. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The REDI intervention that focused on promoting early social-emotional and language skills in preschool moderated the impact of early ACEs on adolescent adjustment and promoted youth resilience, significantly buffering children from the negative impact of early ACEs on their levels of social-emotional distress and school bonding.","['adolescent adjustment of children exposed to early adversity', 'Two hundred ninety-four children from low-income families (58% White, 17% Latinx, 25% Black; 54% girls; Mage = 4.49 years old at study entry) were recruited from Head Start classrooms to participate in a randomized-controlled trial of the project Research-based, Developmentally Informed (REDI) preschool intervention and then followed longitudinally for 10 years through 9th grade']",['preschool intervention'],"['rates of ACEs', 'early social-emotional and language skills', 'adolescent distress and school bonding', 'adverse childhood experiences (ACEs', 'heightened social-emotional distress and reduced levels of school bonding', 'social-emotional distress and school bonding', 'feelings of social-emotional distress and school bonding']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.0182751,"The REDI intervention that focused on promoting early social-emotional and language skills in preschool moderated the impact of early ACEs on adolescent adjustment and promoted youth resilience, significantly buffering children from the negative impact of early ACEs on their levels of social-emotional distress and school bonding.","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Sanders', 'Affiliation': 'Department of Psychology, Pennsylvania State University.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Welsh', 'Affiliation': 'Department of Human Development and Family Studies, Pennsylvania State University.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Bierman', 'Affiliation': 'Department of Psychology, Pennsylvania State University.'}, {'ForeName': 'Brenda S', 'Initials': 'BS', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, Pennsylvania State University.'}]","School psychology (Washington, D.C.)",['10.1037/spq0000406']
2300,32955293,"Big smile, small self: Awe walks promote prosocial positive emotions in older adults.","Aging into later life is often accompanied by social disconnection, anxiety, and sadness. Negative emotions are self-focused states with detrimental effects on aging and longevity. Awe-a positive emotion elicited when in the presence of vast things not immediately understood-reduces self-focus, promotes social connection, and fosters prosocial actions by encouraging a ""small self."" We investigated the emotional benefits of a novel ""awe walk"" intervention in healthy older adults. Sixty participants took weekly 15-min outdoor walks for 8 weeks; participants were randomly assigned to an awe walk group, which oriented them to experience awe during their walks, or to a control walk group. Participants took photographs of themselves during each walk and rated their emotional experience. Each day, they reported on their daily emotional experience outside of the walk context. Participants also completed pre- and postintervention measures of anxiety, depression, and life satisfaction. Compared with participants who took control walks, those who took awe walks experienced greater awe during their walks and exhibited an increasingly ""small self"" in their photographs over time. They reported greater joy and prosocial positive emotions during their walks and displayed increasing smile intensity over the study. Outside of the walk context, participants who took awe walks reported greater increases in daily prosocial positive emotions and greater decreases in daily distress over time. Postintervention anxiety, depression, and life satisfaction did not change from baseline in either group. These results suggest cultivating awe enhances positive emotions that foster social connection and diminishes negative emotions that hasten decline. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Postintervention anxiety, depression, and life satisfaction did not change from baseline in either group.","['Big smile, small self', 'older adults', 'Sixty participants took weekly 15-min outdoor walks for 8 weeks; participants', 'healthy older adults']","['control walk group', 'novel ""awe walk"" intervention']","['daily prosocial positive emotions', 'anxiety, depression, and life satisfaction', 'prosocial positive emotions', 'joy and prosocial positive emotions', 'daily distress', 'Postintervention anxiety, depression, and life satisfaction', 'smile intensity']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0037363', 'cui_str': 'Smiling'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0037363', 'cui_str': 'Smiling'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",60.0,0.0671627,"Postintervention anxiety, depression, and life satisfaction did not change from baseline in either group.","[{'ForeName': 'Virginia E', 'Initials': 'VE', 'LastName': 'Sturm', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Ashlin R K', 'Initials': 'ARK', 'LastName': 'Roy', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Isabel J', 'Initials': 'IJ', 'LastName': 'Sible', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Eena L', 'Initials': 'EL', 'LastName': 'Kosik', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Christina R', 'Initials': 'CR', 'LastName': 'Veziris', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Chow', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Nathaniel A', 'Initials': 'NA', 'LastName': 'Morris', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Neuhaus', 'Affiliation': 'Department of Biostatistics, University of California, San Francisco.'}, {'ForeName': 'Joel H', 'Initials': 'JH', 'LastName': 'Kramer', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Holley', 'Affiliation': 'Department of Psychiatry, San Francisco State University.'}, {'ForeName': 'Dacher', 'Initials': 'D', 'LastName': 'Keltner', 'Affiliation': 'Department of Psychology, University of California, Berkeley.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000876']
2301,32955451,Nonprofessional Peer Support to Improve Mental Health: Randomized Trial of a Scalable Web-Based Peer Counseling Course.,"BACKGROUND


Millions of people worldwide are underserved by the mental health care system. Indeed, most mental health problems go untreated, often because of resource constraints (eg, limited provider availability and cost) or lack of interest or faith in professional help. Furthermore, subclinical symptoms and chronic stress in the absence of a mental illness diagnosis often go unaddressed, despite their substantial health impact. Innovative and scalable treatment delivery methods are needed to supplement traditional therapies to fill these gaps in the mental health care system.
OBJECTIVE


This study aims to investigate whether a self-guided web-based course can teach pairs of nonprofessional peers to deliver psychological support to each other.
METHODS


In this experimental study, a community sample of 30 dyads (60 participants, mostly friends), many of whom presented with mild to moderate psychological distress, were recruited to complete a web-based counseling skills course. Dyads were randomized to either immediate or delayed access to training. Before and after training, dyads were recorded taking turns discussing stressors. Participants' skills in the helper role were assessed before and after taking the course: the first author and a team of trained research assistants coded recordings for the presence of specific counseling behaviors. When in the client role, participants rated the session on helpfulness in resolving their stressors and supportiveness of their peers. We hypothesized that participants would increase the use of skills taught by the course and decrease the use of skills discouraged by the course, would increase their overall adherence to the guidelines taught in the course, and would perceive posttraining counseling sessions as more helpful and their peers as more supportive.
RESULTS


The course had large effects on most helper-role speech behaviors: helpers decreased total speaking time, used more restatements, made fewer efforts to influence the speaker, and decreased self-focused and off-topic utterances (ds=0.8-1.6). When rating the portion of the session in which they served as clients, participants indicated that they made more progress in addressing their stressors during posttraining counseling sessions compared with pretraining sessions (d=1.1), but they did not report substantive changes in feelings of closeness and supportiveness of their peers (d=0.3).
CONCLUSIONS


The results provide proof of concept that nonprofessionals can learn basic counseling skills from a scalable web-based course. The course serves as a promising model for the development of web-based counseling skills training, which could provide accessible mental health support to some of those underserved by traditional psychotherapy.",2020,"The course had large effects on most helper-role speech behaviors: helpers decreased total speaking time, used more restatements, made fewer efforts to influence the speaker, and decreased self-focused and off-topic utterances (ds=0.8-1.6).","['community sample of 30 dyads (60 participants, mostly friends), many of whom presented with mild to moderate psychological distress, were recruited to complete a web-based counseling skills course', 'Mental Health']","['Scalable Web-Based Peer Counseling Course', 'immediate or delayed access to training']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],60.0,0.0411658,"The course had large effects on most helper-role speech behaviors: helpers decreased total speaking time, used more restatements, made fewer efforts to influence the speaker, and decreased self-focused and off-topic utterances (ds=0.8-1.6).","[{'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Bernecker', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Joseph Jay', 'Initials': 'JJ', 'LastName': 'Williams', 'Affiliation': 'Department of Computer Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Norian A', 'Initials': 'NA', 'LastName': 'Caporale-Berkowitz', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin, Austin, TX, United States.'}, {'ForeName': 'Akash R', 'Initials': 'AR', 'LastName': 'Wasil', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts Amherst, Amherst, MA, United States.'}]",Journal of medical Internet research,['10.2196/17164']
2302,32957571,Quercetin Supplementation Improves Neuromuscular Function Recovery from Muscle Damage.,"This study was aimed at investigating whether quercetin (Q) may improve the recovery of neuromuscular function and biochemical parameters in the 7 days following an eccentric exercise-induced muscle damage (EEIMD). Sixteen men (25.9 ± 3.3 y) ingested Q (1000 mg/day) or placebo (PLA) for 14 days following a double-blind crossover study design. A neuromuscular (NM) test was performed pre-post, 24 h, 48 h, 72 h, 96 h and 7 days after an intense eccentric exercise. The force-velocity relationship of the elbow flexor muscles and their maximal voluntary isometric contraction (MVIC) were recorded simultaneously to the electromyographic signals (EMG). Pain, joint angle, arm circumference, plasma creatine kinase (CK) and lactate-dehydrogenase (LDH) were also assessed. The results showed that Q supplementation significantly attenuated the strength loss compared to PLA. During the recovery, force-velocity relationship and mean fibers conduction velocity (MFCV) persisted significantly less when participants consumed PLA rather than Q, especially at the highest angular velocities ( p  < 0.02). A greater increase in biomarkers of damage was also evident in PLA with respect to Q. Q supplementation for 14 days seems able to ameliorate the recovery of eccentric exercise-induced weakness, neuromuscular function impairment and biochemical parameters increase probably due to its strong anti-inflammatory and antioxidant action.",2020,"During the recovery, force-velocity relationship and mean fibers conduction velocity (MFCV) persisted significantly less when participants consumed PLA rather than Q, especially at the highest angular velocities ( p  < 0.02).",['Sixteen men (25.9 ± 3.3 y) ingested Q (1000 mg/day) or'],"['quercetin (Q', 'Quercetin Supplementation', 'placebo (PLA']","['biomarkers of damage', 'force-velocity relationship of the elbow flexor muscles and their maximal voluntary isometric contraction (MVIC', 'recovery, force-velocity relationship and mean fibers conduction velocity (MFCV', 'strength loss', 'Pain, joint angle, arm circumference, plasma creatine kinase (CK) and lactate-dehydrogenase (LDH']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",,0.231259,"During the recovery, force-velocity relationship and mean fibers conduction velocity (MFCV) persisted significantly less when participants consumed PLA rather than Q, especially at the highest angular velocities ( p  < 0.02).","[{'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Bazzucchi', 'Affiliation': 'Laboratory of Exercise Physiology, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Patrizio', 'Affiliation': 'Laboratory of Exercise Physiology, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Ceci', 'Affiliation': 'Laboratory of Biochemistry of Movement, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Guglielmo', 'Initials': 'G', 'LastName': 'Duranti', 'Affiliation': 'Laboratory of Biochemistry of Movement, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Sabatini', 'Affiliation': 'Laboratory of Biochemistry of Movement, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sgrò', 'Affiliation': 'Endocrinology Unit, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Di Luigi', 'Affiliation': 'Endocrinology Unit, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Sacchetti', 'Affiliation': 'Laboratory of Exercise Physiology, Department of Movement, Human and Health Sciences, University of Rome ""Foro Italico"", Piazza Lauro De Bosis 6, 00135 Roma, Italy.'}]",Nutrients,['10.3390/nu12092850']
2303,32957604,Impact of Three-Year Intermittent Preventive Treatment Using Artemisinin-Based Combination Therapies on Malaria Morbidity in Malian Schoolchildren.,"Previous studies have shown that a single season of intermittent preventive treatment in schoolchildren (IPTsc) targeting the transmission season has reduced the rates of clinical malaria, all-cause clinic visits, asymptomatic parasitemia, and anemia. Efficacy over the course of multiple years of IPTsc has been scantly investigated.
METHODS


An open, randomized-controlled trial among schoolchildren aged 6-13 years was conducted from September 2007 to January 2010 in Kolle, Mali. Students were included in three arms: sulphadoxine-pyrimethamine+artesunate (SP+AS), amodiaquine+artesunate (AQ+AS), and control (C). All students received two full doses, given 2 months apart, and were compared with respect to the incidence of clinical malaria, all-cause clinic visits, asymptomatic parasitemia, and anemia.
RESULTS


A total of 296 students were randomized. All-cause clinic visits were in the SP+AS versus control (29 (20.1%) vs. 68 (47.2%); 20 (21.7%) vs. 41 (44.6%); and 14 (21.2%) vs. 30 (44.6%);  p  < 0.02) in 2007, 2008, and 2009, respectively. The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%);  p  < 0.002) in 2007 and 2008, respectively. Hemoglobin concentration was significantly higher in children receiving SP+AS (11.96, 12.06, and 12.62 g/dL) than in control children (11.60, 11.64, and 12.15 g/dL;  p  < 0.001) in 2007, 2008, and 2009, respectively. No impact on clinical malaria was observed.
CONCLUSION


IPTsc with SP+AS reduced the rates of all-cause clinic visits and anemia during a three-year implementation.",2020,"The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%);  p  < 0.002) in 2007 and 2008, respectively.","['schoolchildren aged 6-13 years was conducted from September 2007 to January 2010 in Kolle, Mali', 'A total of 296 students', 'Malian Schoolchildren']","['sulphadoxine-pyrimethamine+artesunate (SP+AS), amodiaquine+artesunate (AQ+AS), and control (C', 'Artemisinin-Based Combination Therapies']","['All-cause clinic visits', 'rates of all-cause clinic visits and anemia', 'Malaria Morbidity', 'Efficacy', 'prevalence of asymptomatic parasitemia', 'Hemoglobin concentration', 'clinical malaria']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0038679', 'cui_str': 'Sulfadoxine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}]",296.0,0.0715299,"The prevalence of asymptomatic parasitemia was lower in the SP+AS compared to control (38 (7.5%) vs. 143 (28.7%); and 47 (12.7%) vs. 75 (21.2%);  p  < 0.002) in 2007 and 2008, respectively.","[{'ForeName': 'Hamma', 'Initials': 'H', 'LastName': 'Maiga', 'Affiliation': 'Institut National de Santé Publique, Bamako 1771, Mali.'}, {'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Barger', 'Affiliation': 'Spokane Emergency Physicians, Spokane, WA 99201, USA.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Guindo', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Oumar B', 'Initials': 'OB', 'LastName': 'Traore', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Mamadou', 'Initials': 'M', 'LastName': 'Tekete', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Dara', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Zoumana I', 'Initials': 'ZI', 'LastName': 'Traore', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Aly', 'Initials': 'A', 'LastName': 'Kodio', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Ousmane B', 'Initials': 'OB', 'LastName': 'Toure', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Ogobara K', 'Initials': 'OK', 'LastName': 'Doumbo', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}, {'ForeName': 'Abdoulaye A', 'Initials': 'AA', 'LastName': 'Djimde', 'Affiliation': 'Malaria Research and Training Center/Department of Epidemiology of Parasitic Diseases, Faculty of Medicine and Dentistry, Faculty of Pharmacy/University of Sciences, Techniques and Technologies of Bamako, Bamako 1805, Mali.'}]",Tropical medicine and infectious disease,['10.3390/tropicalmed5030148']
2304,32957612,"Effect of Daily Intake of Green Tea Catechins on Cognitive Function in Middle-Aged and Older Subjects: A Randomized, Placebo-Controlled Study.","Epidemiological studies in Japan, including the Nakajima study and the Tsurugaya study, have indicated that green tea consumption may improve cognitive impairment. Catechins, which are typical polyphenols contained in green tea, have been reported to have antioxidative, anti-inflammatory, and neuroprotective effects. However, their impact on human cognitive function remains unclear. Therefore, we performed a double-blind, randomized, controlled study to investigate the effect of 336.4 mg of decaffeinated green tea catechins (GTC) on cognitive function after a single dose and after 12 weeks of daily intake. This study included Japanese adults between the ages of 50 and 69 years with a Mini-Mental State Examination Japanese version score of >24 and self-assessed cognitive decline. The Cognitrax testing battery was used to evaluate cognitive function. The incorrect response rate on the Continuous Performance Test significantly decreased after a single dose of GTC. After 12 weeks of daily GTC intake, the response time for Part 4 of the 4-part Continuous Performance Test, which is a two-back test, was shortened. These results suggest that daily intake of GTC might have beneficial effects on working memory.",2020,The incorrect response rate on the Continuous Performance Test significantly decreased after a single dose of GTC.,"['Japanese adults between the ages of 50 and 69 years with a Mini-Mental State Examination Japanese version score of >24 and self-assessed cognitive decline', 'Middle-Aged and Older Subjects']","['decaffeinated green tea catechins (GTC', 'GTC', 'Placebo', 'Green Tea Catechins']","['Cognitive Function', 'cognitive function', 'incorrect response rate', 'cognitive impairment', 'response time']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.149687,The incorrect response rate on the Continuous Performance Test significantly decreased after a single dose of GTC.,"[{'ForeName': 'Yoshitake', 'Initials': 'Y', 'LastName': 'Baba', 'Affiliation': 'Central Research Institute, ITO EN, Ltd., 21 Mekami, Makinohara, Shizuoka 421-0516, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Inagaki', 'Affiliation': 'Central Research Institute, ITO EN, Ltd., 21 Mekami, Makinohara, Shizuoka 421-0516, Japan.'}, {'ForeName': 'Sae', 'Initials': 'S', 'LastName': 'Nakagawa', 'Affiliation': 'Central Research Institute, ITO EN, Ltd., 21 Mekami, Makinohara, Shizuoka 421-0516, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Tokyo Skytree Station Medical Clinic, Ryobi Building F4 33-13 Mukojima 3-chome, Sumida-ku, Tokyo 131-0033, Japan.'}, {'ForeName': 'Makaoto', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Central Research Institute, ITO EN, Ltd., 21 Mekami, Makinohara, Shizuoka 421-0516, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Takihara', 'Affiliation': 'Central Research Institute, ITO EN, Ltd., 21 Mekami, Makinohara, Shizuoka 421-0516, Japan.'}]","Molecules (Basel, Switzerland)",['10.3390/molecules25184265']
2305,32018166,Diurnal rhythm of plasma EPA and DHA in healthy adults.,"Knowledge of the diurnal variation in circulating omega-3 polyunsaturated fatty acids (n-3 PUFAs) may be an important consideration for the development of dosing protocols designed to optimise tissue delivery of these fatty acids. The objective of the current study was to examine the variation in plasma concentrations of eicosapentaenoic acid (EPA; 20:5n-3) and docosahexaenoic acid (DHA; 22:6n-3) over a 24-h period in healthy adults under eating and sleeping conditions generally approximate to a free-living environment. Twenty-one healthy participants aged 25-44 years took part in a single laboratory visit encompassing an overnight stay. EPA and DHA were measured in plasma samples collected every two hours from 22:00 until 22:00 the following day, with all meals being provided at conventional times. Cosinor analysis was used to estimate the diurnal variation in each fatty acid from pooled data across all participants. A significant diurnal variation in the pooled plasma concentrations of both fatty acids was detected. However, evidence of distinct rhythmicity was strongest for DHA. The timing of the peak concentration of DHA was 17:43 with a corresponding nadir at 05:43. In comparison, the observed acrophase for EPA was delayed by three hours, occurring at 20:41, with a nadir at 08:41. This is the first time that the diurnal variation in these important bioactive fatty acids has been described in a sample of healthy adults following a normal pattern of eating and sleeping. In the absence of any dietary intake of EPA and DHA, circulating levels of these fatty acids fall during the overnight period and reach their lowest point in the morning. Consumption of n-3 PUFAs at night time, which counteracts this pattern, may have functional significance.",2020,A significant diurnal variation in the pooled plasma concentrations of both fatty acids was detected.,"['healthy adults under eating and sleeping conditions generally approximate to a free-living environment', 'healthy adults', 'healthy adults following a normal pattern of eating and sleeping', 'Twenty-one healthy participants aged 25-44 years took part in a single laboratory visit encompassing an overnight stay']",['omega-3 polyunsaturated fatty acids (n-3 PUFAs'],"['EPA and DHA', 'peak concentration of DHA', 'Diurnal rhythm of plasma EPA and DHA']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",21.0,0.0535585,A significant diurnal variation in the pooled plasma concentrations of both fatty acids was detected.,"[{'ForeName': 'Philippa A', 'Initials': 'PA', 'LastName': 'Jackson', 'Affiliation': 'Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon Tyne NE1 8ST, United Kingdom. Electronic address: philippa.jackson@northumbria.ac.uk.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Husberg', 'Affiliation': 'BASF AS, Oslo, Norway.'}, {'ForeName': 'Svein-Olaf', 'Initials': 'SO', 'LastName': 'Hustvedt', 'Affiliation': 'BASF AS, Oslo, Norway.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton., Southampton SO16 6YD, United Kingdom; National Institute of Health Research Southampton Biomedical Research Centre, University Hospital Southampton National Health Service Foundation Trust and University of Southampton, Southampton SO16 6YD, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': 'Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon Tyne NE1 8ST, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Avery', 'Affiliation': 'Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon Tyne NE1 8ST, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Forster', 'Affiliation': 'Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon Tyne NE1 8ST, United Kingdom.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Kennedy', 'Affiliation': 'Brain Performance and Nutrition Research Centre, Northumbria University, Newcastle Upon Tyne NE1 8ST, United Kingdom.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102054']
2306,32146983,A Comparative Diabetic Foot Wound Measurement Trial Using Wound Tracker Professional Versus Aranz Imaging System and Conventional Ruler Measurement.,"This is a prospective clinical trial comparing Wound Tracker Professional iOS compatible device with Acetate tracing and Aranz medical wound measuring systems. The study compares 3 different wound measurement systems in 20 patients. Wound Tracker Professional device demonstrated statistically significant difference when compared with the acetate tracing; however, there was no statistically significant difference when compared with the Aranz system. Wound Tracker Professional iOS compatible system is an easily accessible and affordable wound measuring system that can easily be implemented by the clinician in a wound care setting.",2020,"Wound Tracker Professional device demonstrated statistically significant difference when compared with the acetate tracing; however, there was no statistically significant difference when compared with the Aranz system.",['20 patients'],['Wound Tracker Professional Versus Aranz Imaging System and Conventional Ruler Measurement'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",[],20.0,0.0210967,"Wound Tracker Professional device demonstrated statistically significant difference when compared with the acetate tracing; however, there was no statistically significant difference when compared with the Aranz system.","[{'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Reyzelman', 'Affiliation': 'Department of Medicine, California School of Podiatric Medicine at Samuel Merritt University, 3100 Telegraph Avenue, Oakland, CA 94609, USA. Electronic address: areyzelman@samuelmerritt.edu.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'McCray', 'Affiliation': 'Center for Clinical Research, 1107 Mountain Boulevard, Oakland, CA 94611, USA.'}, {'ForeName': 'Lacey Beth', 'Initials': 'LB', 'LastName': 'Peck', 'Affiliation': 'Oregon Foot Care Centers, 200 N.E. 4th Avenue, Hillsboro, OR 97127, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'New Mexico VA Healthcare System, 1501 San Pedro SE, Albuquerque, NM 87108, USA.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Koelewyn', 'Affiliation': 'Northport VA Medical Center/Stony Brook University Hospital, 79 Middleville Road, Northport, NY 11768, USA.'}]",Clinics in podiatric medicine and surgery,['10.1016/j.cpm.2019.12.012']
2307,32349074,Mechanical Ventilation Guided by Uncalibrated Esophageal Pressure May Be Potentially Harmful.,"BACKGROUND


Esophageal balloon calibration was proposed in acute respiratory failure patients to improve esophageal pressure assessment. In a clinical setting characterized by a high variability of abdominal load and intrathoracic pressure (i.e., pelvic robotic surgery), the authors hypothesized that esophageal balloon calibration could improve esophageal pressure measurements. Accordingly, the authors assessed the impact of esophageal balloon calibration compared to conventional uncalibrated approach during pelvic robotic surgery.
METHODS


In 30 adult patients, scheduled for elective pelvic robotic surgery, calibrated end-expiratory and end-inspiratory esophageal pressure, and the associated respiratory variations were obtained at baseline, after pneumoperitoneum-Trendelenburg application, and with positive end-expiratory pressure (PEEP) administration and compared to uncalibrated values measured at 4-ml filling volume, as per manufacturer recommendation. Data are expressed as median and [25th, 75th percentile].
RESULTS


Ninety calibrations were successfully performed. Chest wall elastance worsened with pneumoperitoneum-Trendelenburg and PEEP (19.0 [15.5, 24.6] and 16.7 [11.4, 21.7] cm H2O/l) compared to baseline (8.8 [6.3, 9.8] cm H2O/l; P < 0.0001 for both comparisons). End-expiratory and end-inspiratory calibrated esophageal pressure progressively increased from baseline (3.7 [2.2, 6.0] and 7.7 [5.9, 10.2] cm H2O) to pneumoperitoneum-Trendelenburg (6.2 [3.8, 10.2] and 16.1 [13.1, 20.6] cm H2O; P = 0.014 and P < 0.001) and PEEP (8.8 [7.7, 15.6] and 18.9 [16.3, 22.0] cm H2O; P < 0.0001 vs. baseline for both comparison; P < 0.001 and P = 0.002 vs. pneumoperitoneum-Trendelenburg) and, at each study step, they were persistently lower than uncalibrated esophageal pressure (P < 0.0001 for all comparisons). Overall, difference among uncalibrated and calibrated esophageal pressure was 5.1 [3.8, 8.4] cm H2O at end-expiration and 3.8 [3.0, 6.3] cm H2O at end-inspiration. Uncalibrated esophageal pressure swing was always lower than calibrated one (P < 0.0001 for all comparisons) with a difference of -1.0 [-1.8, -0.4] cm H2O.
CONCLUSIONS


In a clinical setting with variable chest wall mechanics, uncalibrated measurements substantially overestimated absolute values and underestimated respiratory variations of esophageal pressure. Calibration could substantially improve mechanical ventilation guided by esophageal pressure.",2020,"Uncalibrated esophageal pressure swing was always lower than calibrated one (P < 0.0001 for all comparisons) with a difference of -1.0 [-1.8, -0.4] cm","['30 adult patients, scheduled for elective pelvic robotic surgery, calibrated end-expiratory and end-inspiratory esophageal pressure', 'acute respiratory failure patients']",['Mechanical Ventilation Guided by Uncalibrated Esophageal Pressure'],"['Chest wall elastance', 'End-expiratory and end-inspiratory calibrated esophageal pressure', 'uncalibrated and calibrated esophageal pressure', 'PEEP', 'Uncalibrated esophageal pressure swing', 'esophageal pressure measurements', 'uncalibrated esophageal pressure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}]","[{'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",30.0,0.262733,"Uncalibrated esophageal pressure swing was always lower than calibrated one (P < 0.0001 for all comparisons) with a difference of -1.0 [-1.8, -0.4] cm","[{'ForeName': 'Gianmaria', 'Initials': 'G', 'LastName': 'Cammarota', 'Affiliation': 'From the Department of Anesthesiology and Intensive Care, Maggiore della Carità University Hospital, Novara, Italy (G.C., I.S., R.P.) Department of Translational Medicine, Eastern Piedmont University, Novara, Italy (G.L., E.S., F.V., E.Boniolo, R.T., F.D.C., R.V.) Anesthesiology, Critical Care, and Pain Medicine Division, Department of Medicine and Surgery, University of Parma, Parma, Italy (E.Bignami) Anesthesia and Intensive Care, Policlinico S. Matteo IRCCS Foundation, Pavia, Italy (S.M., A.O., F.M.) Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, Unit of Anaesthesia and Intensive Care, University of Pavia, Pavia, Italy (E.A., F.M.).'}, {'ForeName': 'Gianluigi', 'Initials': 'G', 'LastName': 'Lauro', 'Affiliation': ''}, {'ForeName': 'Erminio', 'Initials': 'E', 'LastName': 'Santangelo', 'Affiliation': ''}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Sguazzotti', 'Affiliation': ''}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Perucca', 'Affiliation': ''}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Verdina', 'Affiliation': ''}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Boniolo', 'Affiliation': ''}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Tarquini', 'Affiliation': ''}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bignami', 'Affiliation': ''}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mongodi', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Arisi', 'Affiliation': ''}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Orlando', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Della Corte', 'Affiliation': ''}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Vaschetto', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Mojoli', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003327']
2308,32957850,"Does it make a difference to be more ""on the same page""? Investigating the role of alliance convergence for outcomes in two different samples.","Objective : To better understand the complexity of dyadic processes, such as the mechanisms of the working alliance, researchers recommend taking advantage of innovations in data analytic procedures when studying the interactions between therapists and patients that are associated with favorable therapeutic outcomes. Inspired by a recent line of alliance research using dyadic multilevel modeling, the present study investigated the hypothesis that convergence in the patient-therapist working alliance (i.e., increased similarity in ratings of the alliance across treatment) would be associated with better outcomes.  Method : Data were retrieved from two samples: 1. A randomized controlled trial for treatment resistant depression ( N  = 96 dyads), and 2. An archival dataset of naturalistic psychotherapies from public health care ( N  = 139 dyads). Multilevel growth curve analysis was employed to investigate the degree of change in session-to-session agreement of global WAI ratings between therapists and patients (i.e., alliance convergence) as a predictor of symptom reduction in the BDI-II and the SCL-90R.  Results : Contrary to our expectations, alliance convergence did not predict outcome in either sample, but was negatively associated with symptom severity in Study 2. Implications for understanding the complexity of dyadic processes and alliance work in psychotherapy are discussed.",2020,"Contrary to our expectations, alliance convergence did not predict outcome in either sample, but was negatively associated with symptom severity in Study 2.",['public health care ( N \u2009=\u2009139 dyads'],[],[],"[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C5191072', 'cui_str': '139'}]",[],[],139.0,0.0484727,"Contrary to our expectations, alliance convergence did not predict outcome in either sample, but was negatively associated with symptom severity in Study 2.","[{'ForeName': 'Helene A', 'Initials': 'HA', 'LastName': 'Nissen-Lie', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ole André', 'Initials': 'OA', 'LastName': 'Solbakken', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Falkenström', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Wampold', 'Affiliation': 'University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Holmqvist', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Ekeblad', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Jon T', 'Initials': 'JT', 'LastName': 'Monsen', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1823030']
2309,32957859,A Church-based Culturally Sensitive Physical Activity Intervention in African American Women.,"The purpose of this pilot study was to test a church-based, culturally sensitive, six-week intervention called GET FIT DON'T QUIT. The intervention aimed to increase knowledge and change beliefs about physical activity, and to improve social facilitation to increase self-regulation, in order to promote physical activity in African-American women. A two-group pretest/posttest, quasi-experimental design was conducted in a convenience sample ( N  = 37) of African-American women. Participants were randomly assigned to the intervention or control group by church affiliation. The six-week intervention consisted of teaching and roundtable discussions, and email reminders to be physically active. There were significant differences ( p  < .05) in the level of self-efficacy, self-regulation, and friend social support. There were no significant differences in knowledge of physical activity guidelines, beliefs, and family social support. These pilot study results suggested that multiple factors are associated with physical activity engagement in African-American women.",2020,"There were significant differences ( p  < .05) in the level of self-efficacy, self-regulation, and friend social support.","['convenience sample ( N  = 37) of African-American women', 'African American Women', 'African-American women']","['Church-based Culturally Sensitive Physical Activity Intervention', 'teaching and roundtable discussions, and email reminders to be physically active', 'intervention or control group by church affiliation']","['physical activity engagement', 'level of self-efficacy, self-regulation, and friend social support', 'knowledge of physical activity guidelines, beliefs, and family social support']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",,0.0131767,"There were significant differences ( p  < .05) in the level of self-efficacy, self-regulation, and friend social support.","[{'ForeName': 'Elicia S', 'Initials': 'ES', 'LastName': 'Collins', 'Affiliation': 'Clayton State University, Morrow, GA, USA.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Buchholz', 'Affiliation': 'Rush University, Chicago, IL, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Cranford', 'Affiliation': 'Georgia State University, Atlanta, GA, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'McCrory', 'Affiliation': 'Boston University, Boston, MA, USA.'}]",Western journal of nursing research,['10.1177/0193945920961405']
2310,32957971,Decreased costs and retained QoL due to the 'PACE Steps to Success' intervention in LTCFs: cost-effectiveness analysis of a randomized controlled trial.,"BACKGROUND


The number of residents in long-term care facilities (LTCFs) in need of palliative care is growing in the Western world. Therefore, it is foreseen that significantly higher percentages of budgets will be spent on palliative care. However, cost-effectiveness analyses of palliative care interventions in these settings are lacking. Therefore, the objective of this paper was to assess the cost-effectiveness of the 'PACE Steps to Success' intervention. PACE (Palliative Care for Older People) is a 1-year palliative care programme aiming at integrating general palliative care into day-to-day routines in LTCFs, throughout seven EU countries.
METHODS


A cluster RCT was conducted. LTCFs were randomly assigned to intervention or usual care. LTCFs reported deaths of residents, about whom questionnaires were filled in retrospectively about resource use and quality of the last month of life. A health care perspective was adopted. Direct medical costs, QALYs based on the EQ-5D-5L and costs per quality increase measured with the QOD-LTC were outcome measures.
RESULTS


Although outcomes on the EQ-5D-5L remained the same, a significant increase on the QOD-LTC (3.19 points, p value 0.00) and significant cost-savings were achieved in the intervention group (€983.28, p value 0.020). The cost reduction mainly resulted from decreased hospitalization-related costs (€919.51, p value 0.018).
CONCLUSIONS


Costs decreased and QoL was retained due to the PACE Steps to Success intervention. Significant cost savings and improvement in quality of end of life (care) as measured with the QOD-LTC were achieved. A clinically relevant difference of almost 3 nights shorter hospitalizations in favour of the intervention group was found. This indicates that timely palliative care in the LTCF setting can prevent lengthy hospitalizations while retaining QoL. In line with earlier findings, we conclude that integrating general palliative care into daily routine in LTCFs can be cost-effective.
TRIAL REGISTRATION


ISRCTN14741671 .",2020,"The cost reduction mainly resulted from decreased hospitalization-related costs (€919.51, p value 0.018).
",['for Older People'],"['PACE (Palliative Care', 'LTCFs']","['cost-effectiveness', 'quality of end of life (care', 'Decreased costs and retained QoL', 'hospitalization-related costs', 'QOD-LTC', 'cost-savings']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C4521843', 'cui_str': 'US Military Commissioned Officer O5'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}]",,0.077783,"The cost reduction mainly resulted from decreased hospitalization-related costs (€919.51, p value 0.018).
","[{'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Wichmann', 'Affiliation': 'IQ Health Care, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands. Anne.Wichmann@radboudumc.nl.'}, {'ForeName': 'Eddy M M', 'Initials': 'EMM', 'LastName': 'Adang', 'Affiliation': 'Department for Health Evidencef, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Kris C P', 'Initials': 'KCP', 'LastName': 'Vissers', 'Affiliation': 'Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Szczerbińska', 'Affiliation': 'Unit for Research on Aging Society, Epidemiology and Preventive Medicine Chair, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Kylänen', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Payne', 'Affiliation': 'Division of Health Research, Lancaster University, Lancaster, England.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gambassi', 'Affiliation': 'Faculty of Medicine and Surgery, Fondazione Policlinico Universitario A. Gemelli, IRCCS and Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Bregje D', 'Initials': 'BD', 'LastName': 'Onwuteaka-Philipsen', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tinne', 'Initials': 'T', 'LastName': 'Smets', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Brussel, Belgium.'}, {'ForeName': 'Lieve', 'Initials': 'L', 'LastName': 'Van den Block', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Brussel, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Deliens', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Brussel, Belgium.'}, {'ForeName': 'Myrra J F J', 'Initials': 'MJFJ', 'LastName': 'Vernooij-Dassen', 'Affiliation': 'IQ Health Care, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Engels', 'Affiliation': 'Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC medicine,['10.1186/s12916-020-01720-9']
2311,32958010,From sensitization to adoption? A qualitative study of the implementation of a digitally supported intervention for clinical decision making in polypharmacy.,"OBJECTIVE


Formative evaluation of the implementation process for a digitally supported intervention in polypharmacy in Germany. Qualitative research was conducted within a cluster randomized controlled trial (C-RCT). It focused on understanding how the intervention influences behavior-related outcomes in the prescription and medication review process.
METHODS/SETTING


Twenty-seven general practitioners (GPs) were included in the study in the two groups of the C-RCT, the intervention, and the wait list control group. Behavior-related outcomes were investigated using three-step data analysis (content analytic approach, documentary method, and design of a model of implementation pathways).
RESULTS


Content analysis showed that physicians were more intensely aware of polypharmacy-related risks, described positive learning effects of the digital technology on their prescribing behavior, and perceived a change in communication with patients and pharmacists. Conversely, they felt uncertain about their own responsibility when prescribing. Three main dimensions were discovered which influenced adoption behavior: (1) the physicians' interpretation of the relevance of pharmaceutical knowledge provided by the intervention in changing decision-making situations in polypharmacy; (2) their medical code of ethics for clinical decision making in the context of progressing digitalization; and (3) their concepts of evidence-based medicine on the basis of professional experiences with polypharmacy in primary care settings. In our sample, both simple and complex pathways from sensitization to adoption were observed. The resulting model on adoption behavior includes a paradigmatic description of different pathways and a visualization of different observed levels and applied methodological approaches. We assumed that the GP habitus can weaken or strengthen interventional effects towards intervention uptake. This formative evaluation strategy is beneficial for the identification of behavior-related implementation barriers and facilitators.
CONCLUSION


Our analyses of the adoption behavior of a digitally supported intervention in polypharmacy revealed both simple and complex pathways from awareness to adoption, which may impact the implementation of the intervention and therefore, its effectiveness. Future consideration of adoption behavior in the planning and evaluation of digitally supported interventions may enhance uptake and support the interpretation of effects.
TRIAL REGISTRATION


NCT03430336 , 12 February 2018.",2020,"RESULTS


Content analysis showed that physicians were more intensely aware of polypharmacy-related risks, described positive learning effects of the digital technology on their prescribing behavior, and perceived a change in communication with patients and pharmacists.","['Twenty-seven general practitioners (GPs) were included in the study in the two groups of the C-RCT, the intervention, and the wait list control group', 'polypharmacy in Germany']",[],[],"[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]",[],[],,0.0552635,"RESULTS


Content analysis showed that physicians were more intensely aware of polypharmacy-related risks, described positive learning effects of the digital technology on their prescribing behavior, and perceived a change in communication with patients and pharmacists.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Söling', 'Affiliation': 'Institute for Medical Sociology, Health Services Research and Rehabilitation Science, Department of Health Services Research, University of Cologne, Cologne, Germany. sara.soeling@uk-koeln.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Köberlein-Neu', 'Affiliation': 'Center for Health Economics and Health Services Research, Schumpeter School of Business and Economics, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Beate Sigrid', 'Initials': 'BS', 'LastName': 'Müller', 'Affiliation': 'Institute of General Practice, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Truc Sophia', 'Initials': 'TS', 'LastName': 'Dinh', 'Affiliation': 'Institute of General Practice, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Muth', 'Affiliation': 'Institute of General Practice, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Pfaff', 'Affiliation': 'Institute for Medical Sociology, Health Services Research and Rehabilitation Science, Department of Health Services Research, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Karbach', 'Affiliation': 'Department Sociology in Rehabilitation, Faculty of Rehabilitation Sciences, Technical University Dortmund, Dortmund, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Implementation science : IS,['10.1186/s13012-020-01043-6']
2312,32950343,Intra-articular Injections of the Hip and Knee With Triamcinolone vs Ketorolac: A Randomized Controlled Trial.,"BACKGROUND


Clinicians commonly utilize intra-articular injections to treat symptomatic primary arthritis. Steroid injections are common yet have immune-modulating effects and can alter gene expression which may delay definitive arthroplasty and further damage cartilage. Nonsteroidal anti-inflammatory injections may offer a safer profile due to their differing mechanism of action; however, there is a relative dearth of information regarding their efficacy. This noninferiority study compares the effectiveness of triamcinolone vs ketorolac in treating symptoms of moderate to advanced primary osteoarthritis of the hip and knee.
METHODS


In total, 110 patients (52 hips and 58 knees) with moderate to severe radiographic primary osteoarthritis of the hip or knee were randomized in a double-blinded study to receive an ultrasound-guided intra-articular injection of ketorolac or triamcinolone. Patient-reported outcome measures were collected pre-injection and at 1 week, 1 month, and 3 months.
RESULTS


For hips and knees, intra-articular injections with either ketorolac or triamcinolone led to statistically significant improvements in patient-reported outcome measures. The treatment effect size was largest at 1 week and decreased over time. Primary analysis of variance comparisons revealed no significant differences between ketorolac and triamcinolone. For knee injections, post hoc secondary analysis suggests slight added durability in the triamcinolone group. Adverse effects were minimal with both interventions.
CONCLUSION


Intra-articular ketorolac injections provide comparable improvement to triamcinolone for primary hip and knee osteoarthritis. Ketorolac is an additional low-cost option for conservative management of primary osteoarthritis, and due to its differing mechanism of action, it may not propagate additional cartilage damage or preclude from early surgical intervention if unsuccessful.
TRIAL REGISTRATION NUMBER


NCT04441112.",2020,Primary analysis of variance comparisons revealed no significant differences between ketorolac and triamcinolone.,"['primary hip and knee osteoarthritis', '110 patients (52 hips and 58 knees) with moderate to severe radiographic primary osteoarthritis of the hip or knee', 'moderate to advanced primary osteoarthritis of the hip and knee']","['ketorolac', 'Steroid injections', 'Triamcinolone', 'triamcinolone vs ketorolac', 'triamcinolone', 'ultrasound-guided intra-articular injection of ketorolac or triamcinolone', 'Nonsteroidal anti-inflammatory injections', 'Intra-articular Injections of the Hip and Knee', 'Ketorolac']",['Adverse effects'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}]",110.0,0.179479,Primary analysis of variance comparisons revealed no significant differences between ketorolac and triamcinolone.,"[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Jurgensmeier', 'Affiliation': 'University of Washington, School of Medicine, Seattle, Washington.'}, {'ForeName': 'Darin', 'Initials': 'D', 'LastName': 'Jurgensmeier', 'Affiliation': 'Saint Alphonsus Joint Preservation & Reconstruction, Department of Orthopedics, Boise, Idaho.'}, {'ForeName': 'Derek E', 'Initials': 'DE', 'LastName': 'Kunz', 'Affiliation': 'Saint Alphonsus Joint Preservation & Reconstruction, Department of Orthopedics, Boise, Idaho.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Fuerst', 'Affiliation': 'University of Washington, School of Medicine, WWAMI Medical Education Program, Moscow, Idaho.'}, {'ForeName': 'Lucian C', 'Initials': 'LC', 'LastName': 'Warth', 'Affiliation': 'IU Health Saxony Hospital, Department of Orthopedics, Fishers, Indiana.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Daines', 'Affiliation': 'Saint Alphonsus Joint Preservation & Reconstruction, Department of Orthopedics, Boise, Idaho.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.08.036']
2313,32950349,"The effect of yoga on uterine artery Doppler indices, maternal and fetal complications in pregnant women: A quasi-experimental study.","BACKGROUND


Today, the effect of yoga has been examined on various physical and psychological dimensions of pregnant women. However, there are still sparse studies on the effect of yoga on the uterine artery indices as well as maternal and fetal complications.
OBJECTIVE


The aim was to determine the effect of yoga on uterine artery Doppler indices, maternal and fetal Complications.
METHODS


This quasi-experiential study was conducted, on 100 pregnant women. The participants were assigned to yoga and control groups. In the yoga group, the participants exercised yoga for 1 h. On the other hand, the control group received routine care.
RESULTS


The results showed that in the yoga group, the functional indices of the uterine artery (S/D, PI, RI, and DN) improved more significantly compared to the control (p = 0.01). The results also showed that in the yoga group, maternal complications (diabetes and preeclampsia), as well as fetal complications (SAG, IUGR), were significantly lower compared to the control (p = 0.01).
CONCLUSION


This study revealed the positive effects of yoga on improving fetal development indices and reducing maternal and fetal complications following pregnancy. It can be used as a Complementary therapy alongside other treatments for mothers.",2020,"The results showed that in the yoga group, the functional indices of the uterine artery (S/D, PI, RI, and DN) improved more significantly compared to the control (p = 0.01).","['pregnant women', 'mothers', '100 pregnant women']",['routine care'],"['fetal complications (SAG, IUGR', 'functional indices of the uterine artery (S/D, PI, RI, and DN', 'uterine artery Doppler indices, maternal and fetal Complications', 'maternal complications (diabetes and preeclampsia', 'fetal development indices and reducing maternal and fetal complications', 'uterine artery Doppler indices, maternal and fetal complications']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0851390', 'cui_str': 'Foetal complications'}, {'cui': 'C0574427', 'cui_str': 'Sango language'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0015928', 'cui_str': 'Fetal Development'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",100.0,0.0235501,"The results showed that in the yoga group, the functional indices of the uterine artery (S/D, PI, RI, and DN) improved more significantly compared to the control (p = 0.01).","[{'ForeName': 'Salehoddin', 'Initials': 'S', 'LastName': 'Bouya', 'Affiliation': 'Internal Medicine and Nephrology, Clinical Immunology Research Center, Ali-ebne Abitaleb Hospital, Zahedan University of Medical Sciences, Iran.'}, {'ForeName': 'Leli', 'Initials': 'L', 'LastName': 'Rezaie Keikhaie', 'Affiliation': 'Department of Infectious Disease, School of Medicine, Zabol University of Medical Science, Zabol, Iran.'}, {'ForeName': 'SaraSadat', 'Initials': 'S', 'LastName': 'Hosseini', 'Affiliation': 'Medical-Surgical Nursing, Department of Nursing, Neyshabur University of Medical Science, Neyshabur, Iran.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Rezaie Keikhaie', 'Affiliation': 'Department of Obstetrics and Gynecology, Zabol University of Medical Sciences, Zabol, Iran. Electronic address: krezak1990@gmail.com.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2020.07.003']
2314,32950400,Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.,"We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.",2020,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","['Latino emergency department patients', 'English and/or Spanish speaking self-identified adult Latino ED patients', 'Latino patients', 'unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD']","['automated bilingual computerized alcohol screening and brief intervention (AB-CASI', 'bilingual digital health tool']","['mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school', 'number of binge drinking days assessed using the 28-day timeline followback method']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.0627793,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","[{'ForeName': 'Federico E', 'Initials': 'FE', 'LastName': 'Vaca', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: federico.vaca@yale.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: james.dziura@yale.edu.'}, {'ForeName': 'Fuad', 'Initials': 'F', 'LastName': 'Abujarad', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: fuad.abujarad@yale.edu.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: michael.pantalon@yale.edu.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hsiao', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America; Yale School of Medicine, Department of Pediatrics, Section of Emergency Medicine, 100 York St, Suite 1F, New Haven, CT 06511, United States of America. Electronic address: allen.hsiao@yale.edu.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'University of Texas at El Paso, Latino Alcohol and Health Disparities Research Center (LAHDR), Psychology Building; Rooms 102 and 104, The University of Texas at El Paso, El Paso, TX 79968, United States of America. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': ""D'Onofrio"", 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: gail.donofrio@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106128']
2315,32950413,Is There Still Hope for Infrapopliteal PCB Angioplasty?: Positive Data From the ACOART-BTK Single-Center Randomized Trial.,,2020,,[],[],[],[],[],[],,0.0782123,,"[{'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Spiliopoulos', 'Affiliation': '2nd Department of Radiology, National and Kapodistrian University of Athens, ""Attikon"" University General Hospital, Athens, Greece. Electronic address: stavspiliop@med.uoa.gr.'}, {'ForeName': 'Lazaros', 'Initials': 'L', 'LastName': 'Reppas', 'Affiliation': '2nd Department of Radiology, National and Kapodistrian University of Athens, ""Attikon"" University General Hospital, Athens, Greece.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.07.027']
2316,32950416,Randomized Controlled Trial of Acotec Drug-Eluting Balloon Versus Plain Balloon for Below-the-Knee Angioplasty.,"OBJECTIVES


The aim of this study was to investigate the efficacy and safety of the Litos drug-coated balloon (DCB) versus plain old balloon angioplasty (POBA) for reduction of late lumen loss (LLL) in patients with critical limb ischemia undergoing below-the-knee (BTK) intervention.
BACKGROUND


Restenosis after balloon angioplasty of BTK arteries approximates 70%. Previous studies of DCBs in BTK arteries produced conflicting results.
METHODS


ACOART-BTK (Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos® in Below-the-Knee Arteries to Treat Critical Limb Ischemia) is a randomized controlled single-center study. Inclusion criteria were critical limb ischemia (Rutherford class ≥4) and significant stenosis or occlusion >40 mm of at least 1 BTK vessel with distal runoff successfully treated with angioplasty. Six-month angiographic LLL was the primary endpoint. Occlusive restenosis at 6 months and clinically driven target lesion revascularization at 12 months were secondary endpoints.
RESULTS


From January 2016 through January 2019, 105 patients with 129 BTK lesions were enrolled in the study. Mean lesion length was 168 ± 109 mm in the DCB group and 187 ± 113 mm in the POBA group (p = 0.30). Almost 70% of lesions were occluded at baseline in both groups. On 6-month angiography, mean LLL was 0.51 ± 0.60 mm in the DCB group and 1.31 ± 0.72 mm in the POBA group (p < 0.001); rates of occlusive restenosis were 8.6% and 48.4%, respectively (p < 0.001). Twelve-month clinically driven target lesion revascularization occurred in 6 of 62 DCB-treated lesions (10%) versus 27 of 66 POBA-treated lesions (41%) (p < 0.001). Complete healing at 12 months was observed in 42 of 47 DCB-treated limbs (89.4) versus 35 of 47 POBA-treated limbs (74.5%) (p = 0.05); no major amputations occurred.
CONCLUSIONS


Litos DCBs strikingly reduced LLL, vessel reocclusion, and clinically driven target lesion revascularization compared with POBA in BTK angioplasty.",2020,Mean lesion length was 168 ± 109 mm in the DCB group and 187 ± 113 mm in the POBA group (p = 0.30).,"['patients with critical limb ischemia undergoing below-the-knee (BTK) intervention', 'From January 2016 through January 2019, 105 patients with 129 BTK lesions were enrolled in the study']","['Litos drug-coated balloon (DCB', 'Acotec Drug-Eluting Balloon Versus Plain Balloon', 'angioplasty', 'plain old balloon angioplasty (POBA']","['Occlusive restenosis', 'Complete healing', 'rates of occlusive restenosis', 'efficacy and safety', 'LLL, vessel reocclusion', 'late lumen loss (LLL', 'target lesion revascularization', 'Mean lesion length', 'stenosis or occlusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}]","[{'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0854571', 'cui_str': 'Reocclusion'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",105.0,0.093439,Mean lesion length was 168 ± 109 mm in the DCB group and 187 ± 113 mm in the POBA group (p = 0.30).,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Liistro', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy. Electronic address: francescoliistro@hotmail.com.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Angioli', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ventoruzzo', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ducci', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Matteo Rocco', 'Initials': 'MR', 'LastName': 'Reccia', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Ricci', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Falsini', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Scatena', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pieroni', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Cardiovascular Department, San Donato Hospital, Arezzo, Italy.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.06.045']
2317,32950419,Aspirin-Free Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study.,"OBJECTIVES


The aim of this study was to evaluate the hypothesis that prasugrel monotherapy following successful everolimus-eluting stent implantation is feasible and safe in patients with stable coronary artery disease (CAD).
BACKGROUND


Recent studies have suggested that short dual-antiplatelet therapy strategies may provide an adequate balance between ischemic and bleeding risks. However, the complete omission of aspirin immediately after percutaneous coronary intervention (PCI) has not been tested so far.
METHODS


The study was a multicenter, single-arm, open-label trial with a stopping rule based on the occurrence of definite stent thrombosis (if >3, trial enrollment would be terminated). Patients undergoing successful everolimus-eluting stent implantation for stable CAD with SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores <23 were included. All participants were on standard dual-antiplatelet therapy at the time of index PCI. Aspirin was discontinued on the day of the index procedure but given prior to the procedure; prasugrel was administered in the catheterization laboratory immediately after the successful procedure, and aspirin-free prasugrel became the therapy regimen from that moment. Patients were treated solely with prasugrel for 3 months. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 3 months.
RESULTS


From February 22, 2018, to May 7, 2019, 201 patients were enrolled. All patients underwent PCI for stable CAD. Overall, 98.5% of patients were adherent to prasugrel at 3-month follow-up. The primary ischemic and bleeding endpoints occurred in 1 patient (0.5%). No stent thrombosis events occurred.
CONCLUSIONS


Aspirin-free prasugrel monotherapy following successful everolimus-eluting stent implantation demonstrated feasibility and safety without any stent thrombosis in selected low-risk patients with stable CAD. These findings may help underpin larger randomized controlled studies to evaluate the aspirin-free strategy compared with traditional dual-antiplatelet therapy following PCI. (Acetyl Salicylic Elimination Trial: The ASET Pilot Study [ASET]; NCT03469856).",2020,"No stent thrombosis events occurred.
","['patients with stable coronary artery disease (CAD', 'Patients undergoing successful everolimus-eluting stent implantation for stable CAD with SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores\xa0<23 were included', 'Patients', 'selected low-risk patients with stable CAD', 'From February 22, 2018, to May 7, 2019, 201 patients were enrolled']","['Stable CAD', 'everolimus-eluting stent implantation', 'Coronary Artery Stenting', 'Aspirin', 'aspirin', 'Aspirin-Free Prasugrel Monotherapy']","['primary ischemic and bleeding endpoints', 'stent thrombosis events', 'composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 3\xa0months']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",201.0,0.0631436,"No stent thrombosis events occurred.
","[{'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands; Department of Cardiology, Toho University Medical Center Ohashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Patricia O', 'Initials': 'PO', 'LastName': 'Guimarães', 'Affiliation': 'Heart Institute - InCor, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'De Martino', 'Affiliation': 'Department of Internal Medicine, Discipline of Cardiology, University of Triangulo Mineiro, Uberaba, Brazil.'}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Tinoco', 'Affiliation': 'Instituto Cardiovascular de Linhares LTDA - UNICOR, Linhares, Brazil.'}, {'ForeName': 'Expedito E', 'Initials': 'EE', 'LastName': 'Ribeiro', 'Affiliation': 'Heart Institute - InCor, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Cavalcante', 'Affiliation': 'Boston Scientific, Marlborough, Massachusetts.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Moulin', 'Affiliation': 'Associação Evangélica Beneficiente Espírito Santense, Vila Velha, Brazil.'}, {'ForeName': 'Breno A A', 'Initials': 'BAA', 'LastName': 'Falcão', 'Affiliation': 'Hospital Dr. Carlos Alberto Studart Gomes de Messejana, Fortaleza, Brazil.'}, {'ForeName': 'Rogerio S', 'Initials': 'RS', 'LastName': 'Leite', 'Affiliation': 'Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia, Porto Alegre, Brazil.'}, {'ForeName': 'Fernanda Barbosa', 'Initials': 'FB', 'LastName': 'de Almeida Sampaio', 'Affiliation': 'Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gustavo R', 'Initials': 'GR', 'LastName': 'Morais', 'Affiliation': 'Hospital Nossa Senhora das Neves, João Pessoa, Brazil.'}, {'ForeName': 'George C', 'Initials': 'GC', 'LastName': 'Meireles', 'Affiliation': 'Hospital do Servidor Público Estadual - IAMSPE, São Paulo, Brazil.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Campos', 'Affiliation': 'Heart Institute - InCor, University of São Paulo, São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland; Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Lemos', 'Affiliation': 'Heart Institute - InCor, University of São Paulo, São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo, Brazil. Electronic address: pedro.lemos@atscien.com.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.06.023']
2318,32950590,A placebo-controlled randomised trial of budesonide for primary biliary cholangitis following an insufficient response to UDCA.,"BACKGROUND & AIMS


In patients with primary biliary cholangitis (PBC) the utility of budesonide, a synthetic corticosteroid displaying high first-pass metabolism, is unresolved. In a placebo-controlled, double-blind trial, we evaluated the added-value of budesonide in those with PBC and ongoing risk of progressive disease despite ursodeoxycholic acid (UDCA).
METHODS


We evaluated 62 patients with PBC who had histologically confirmed hepatic inflammatory activity, according to the Ishak-score, and an alkaline phosphatase (ALP) >1.5x upper limit of normal (ULN), after at least 6 months of UDCA therapy. Participants were randomly assigned 2:1 to receive budesonide (9 mg/day) or placebo once daily, for 36 months, with UDCA treatment (12-16 mg/kg body weight/day) maintained. Primary efficacy was defined as improvement of liver histology with respect to inflammation and no progression of fibrosis. Secondary outcomes included changes in biochemical markers of liver injury.
RESULTS


Recruitment challenges resulted in a study underpowered compared to original intent. The primary histologic endpoint, comparing patients with paired biopsies only (n= 43), was not met (p>0.05). The proportion of patients with ALP <1.67xULN, ≥15% decrease and normal bilirubin, was higher in the budesonide group than in the placebo group at 12, 24, and 36 months (p<0.05, each). In contrast to placebo, budesonide reduced mean ALP, and 35% of budesonide-treated patients had normalisation of ALP (Placebo: 9%; p=0.023). Serious adverse events occurred in 10 patients receiving budesonide and 7 patients receiving placebo.
CONCLUSION


Budesonide add-on therapy in patients with PBC, and insufficient response to UDCA, did not associate with improvement in liver histology; improvements in biochemical markers of disease activity were demonstrated in secondary analyses.",2020,"The proportion of patients with ALP <1.67xULN, ≥15% decrease and normal bilirubin, was higher in the budesonide group than in the placebo group at 12, 24, and 36 months (p<0.05, each).","['patients with PBC', '62 patients with PBC who had histologically confirmed hepatic inflammatory activity, according to the Ishak-score, and an alkaline phosphatase (ALP) >1.5x upper limit of normal (ULN), after at least 6 months of UDCA therapy', 'patients with primary biliary cholangitis (PBC', '10 patients receiving']","['ALP (Placebo', 'Budesonide', 'UDCA treatment', 'budesonide', 'ursodeoxycholic acid (UDCA', 'placebo', 'placebo, budesonide']","['liver histology with respect to inflammation and no progression of fibrosis', 'changes in biochemical markers of liver injury', 'normal bilirubin', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}, {'cui': 'C0858307', 'cui_str': 'Bilirubin normal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",62.0,0.439914,"The proportion of patients with ALP <1.67xULN, ≥15% decrease and normal bilirubin, was higher in the budesonide group than in the placebo group at 12, 24, and 36 months (p<0.05, each).","[{'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Hirschfield', 'Affiliation': 'Toronto Centre for Liver Disease, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada. Electronic address: gideon.hirschfield@uhn.ca.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Beuers', 'Affiliation': 'Department of Gastroenterology & Hepatology and Tytgat Institute for Liver and Intestinal Research, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kupcinskas', 'Affiliation': 'Department of Gastroenterology & Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ott', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bergquist', 'Affiliation': 'Department of Gastroenterology & Hepatology, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Färkkilä', 'Affiliation': 'Helsinki University and Helsinki University Hospital, Clinic of Gastroenterology, Helsinki Finland.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Manns', 'Affiliation': 'Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Parés', 'Affiliation': 'Liver Unit, Hospital Clínic, IDIBAPS, University of Barcelona, CIBERehd, Barcelona, Spain.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Spengler', 'Affiliation': 'Department of Internal Medicine I, University of Bonn, Bonn, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stiess', 'Affiliation': 'Research and Development, Dr. Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Greinwald', 'Affiliation': 'Research and Development, Dr. Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pröls', 'Affiliation': 'Research and Development, Dr. Falk Pharma GmbH, Freiburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wendum', 'Affiliation': ""Service d'Anatomie et Cytologie Pathologiques Hôpital Saint-Antoine, 184, rue du Faubourg Saint-Antoine 75571 PARIS cedex 12; Sorbonne Université, INSERM UMR_S938, Centre de Recherche Saint-Antoine(CRSA), 75012 Paris, France.""}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Drebber', 'Affiliation': 'Institute of Pathology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Poupon', 'Affiliation': ""Service d'Hépatologie, Centre national de référence des maladies inflammatoires du foie et des voies biliaires, Hôpital Saint-Antoine, Paris, France.""}]",Journal of hepatology,['10.1016/j.jhep.2020.09.011']
2319,32950597,Size of Lugol-unstained lesions as a predictor for risk of progression in premalignant lesions of the esophagus.,"BACKGROUND AND AIMS


At present, surveillance strategy for pre-malignant esophageal lesions in China is based solely on the pathologic diagnosis in Lugol's chromoendoscopy (LCE). In this study, we sought to determine the degree to which various unstained features under LCE may lead to improved ability to predict the risk of progression in esophageal lesions.
METHODS


We re-examined and followed up on 1058 subjects who had Lugol-unstained lesions (LUL) together with a pathologic diagnosis, which was lower than severe dysplasia at baseline screening based on a population-based randomized controlled trial over a median time of 5.8 years. We established a logistic regression model and calculated the adjusted cumulative incidence of severe dysplasia or malignancy.
RESULTS


LUL size was predictive of progression to malignant lesions in individuals with a nondysplastic diagnosis (adjusted OR  6-10 mm VS ≤5 mm  =6.7; 95% CI, 1.7-25.7; adjusted OR  >10 mm VS ≤5 mm  =27.9; 95% CI, 7.3-105.7), and the corresponding adjusted cumulative incidence of malignant lesions was 3.6 and 13.2 per 100 persons. This is higher than that of small (≤5mm) lesions, which showed mild dysplasia (2.7 per 100 persons), a condition for which surveillance every 3 years is recommended. 65.3% of interval cancers missed at surveillance under the current approach would be detected if individuals with medium (6-10 mm) and large (>10 mm) nondysplastic LULs were additional monitored.
CONCLUSIONS


We propose a modified surveillance strategy that combines findings under LCE examination and the pathologic analysis, where follow-up endoscopy is recommended for individuals with relatively large nondysplastic lesions.",2020,"RESULTS


LUL size was predictive of progression to malignant lesions in individuals with a nondysplastic diagnosis (adjusted OR  6-10 mm VS ≤5 mm  =6.7; 95% CI, 1.7-25.7; adjusted OR  >10 mm VS ≤5 mm  =27.9; 95% CI, 7.3-105.7), and the corresponding adjusted cumulative incidence of malignant lesions was 3.6 and 13.2 per 100 persons.","['individuals with relatively large nondysplastic lesions', '1058 subjects who had Lugol-unstained lesions (LUL) together with a pathologic diagnosis, which was lower than severe dysplasia at baseline screening based on a population-based randomized controlled trial over a median time of 5.8 years']",[],['malignant lesions'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0065234', 'cui_str': ""Lugol's solution""}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0334048', 'cui_str': 'Severe dysplasia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",1058.0,0.170061,"RESULTS


LUL size was predictive of progression to malignant lesions in individuals with a nondysplastic diagnosis (adjusted OR  6-10 mm VS ≤5 mm  =6.7; 95% CI, 1.7-25.7; adjusted OR  >10 mm VS ≤5 mm  =27.9; 95% CI, 7.3-105.7), and the corresponding adjusted cumulative incidence of malignant lesions was 3.6 and 13.2 per 100 persons.","[{'ForeName': 'Mengfei', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Rd, Beijing, 100142, P.R. China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Rd, Beijing, 100142, P.R. China.'}, {'ForeName': 'Chuanhai', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Rd, Beijing, 100142, P.R. China.'}, {'ForeName': 'Ruiping', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Anyang Cancer Hospital, Anyang, Henan Province, P.R. China.'}, {'ForeName': 'Anxiang', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Endoscopy center, Anyang Cancer Hospital, Anyang, Henan Province, P.R. China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of pathology, Anyang Cancer Hospital, Anyang, Henan Province, P.R. China.'}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Hua County People's Hospital, Anyang, Henan Province, P.R. China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Duan', 'Affiliation': 'Department of Gastroenterology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Endoscopy Center, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Rd, Beijing, 100142, P.R. China.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Rd, Beijing, 100142, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Rd, Beijing, 100142, P.R. China.'}, {'ForeName': 'Yaqi', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Rd, Beijing, 100142, P.R. China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Rd, Beijing, 100142, P.R. China.'}, {'ForeName': 'Noel S', 'Initials': 'NS', 'LastName': 'Weiss', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle, Washington. Electronic address: nweiss@uw.edu.'}, {'ForeName': 'Zhonghu', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Rd, Beijing, 100142, P.R. China. Electronic address: zhonghuhe@foxmail.com.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ke', 'Affiliation': 'Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Laboratory of Genetics, Peking University Cancer Hospital & Institute, #52 Fucheng Rd, Beijing, 100142, P.R. China. Electronic address: keyang@bjmu.edu.cn.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.09.020']
2320,32950613,A 4-week exercise and protein program improves muscle mass and physical functioning in older adults - A pilot study.,"BACKGROUND


Prehabilitation might attenuate common surgery-induced losses in muscle mass and physical performance. Beneficial effects of physical exercise with protein supplementation have been reported in older adults, but typically after an intervention of at least 12 weeks. The time-window for pre-surgery training is often limited to around 30 days, and it is not known if it is possible to achieve comparable results in such a short time window.
OBJECTIVES


The aim of this study was to pilot-test the effectiveness of a controlled four-week combined exercise and protein supplementation program on skeletal muscle-related outcomes in a Dutch older adult population.
DESIGN


This study was a one-armed pilot trial.
PARTICIPANTS


Seventeen older men and women, aged 55-75y, not scheduled for surgery.
INTERVENTION


A 4-week intervention program consisting of a twice-weekly supervised resistance and high-intensity aerobic exercise training of 75 min, combined with daily protein supplementation (2 doses of 15.5 g/day at breakfast and lunch).
MEASUREMENT


After two and four weeks, isometric quadriceps maximal voluntary contraction (MVC) was assessed via Biodex and quadriceps cross-sectional area (CSA) via magnetic resonance imaging. Other outcome measures were handgrip strength, chair rise time and maximal aerobic capacity (VO 2 -max), as assessed from a submaximal exercise test.
RESULTS


Compliance to the supervised training sessions (99.3%) and the protein supplementation (97%) was very high. The 4-week exercise and protein program led to an increase in quadriceps CSA of 2.3 ± 0.7 cm 2  (P = 0.008) in the dominant leg and 3.2 ± 0.7 cm 2  (P < 0.001) in the non-dominant leg. Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003). Chair rise test time improved with -3.8 ± 0.5 s (P < 0.0001), and VO 2 -max improved with 3.3 ± 1.1 ml/min/kg (P = 0.014). We observed no changes in body weight and handgrip strength.
CONCLUSION


A 4-week exercise and protein intervention led to improvements in muscle-related outcomes in older adults with low levels of physical activity.",2020,"Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003).","['older adults', 'Seventeen older men and women, aged 55-75y, not scheduled for surgery', 'older adults with low levels of physical activity', 'Dutch older adult population']","['combined exercise and protein supplementation program', 'exercise and protein intervention', 'exercise and protein program', 'intensity aerobic exercise training of 75\u202fmin, combined with daily protein supplementation', 'physical exercise with protein supplementation']","['muscle mass and physical functioning', 'isometric quadriceps maximal voluntary contraction (MVC', 'Isometric quadriceps MVC', 'Chair rise test time', 'VO 2 -max', 'handgrip strength, chair rise time and maximal aerobic capacity (VO 2 -max), as assessed from a submaximal exercise test', 'body weight and handgrip strength']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",17.0,0.0475282,"Isometric quadriceps MVC increased in the dominant leg (Δ14 ± 4 Nm, P = 0.001) and in the non-dominant leg (Δ17 ± 5 Nm, P = 0.003).","[{'ForeName': 'Pol', 'Initials': 'P', 'LastName': 'Grootswagers', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands. Electronic address: pol.grootswagers@wur.nl.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'de Regt', 'Affiliation': 'Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Jacintha', 'Initials': 'J', 'LastName': 'Domić', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Dronkers', 'Affiliation': 'Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands; Research group Innovation and Movement Care, University of Applied Science, Utrecht, the Netherlands.'}, {'ForeName': 'Marlieke', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Science Office, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Witteman', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands; Department of Physical Therapy, Gelderse Vallei Hospital, Ede, the Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hopman', 'Affiliation': 'Department of Physiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mensink', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, P.O. Box 17, 6700 AA Wageningen, the Netherlands.'}]",Experimental gerontology,['10.1016/j.exger.2020.111094']
2321,32950645,Rationale and protocol for translating basic habituation research into family-based childhood obesity treatment: Families becoming healthy together study.,"This publication describes the rationale and protocol, including design, aims, intervention, and measures, of Families Becoming Healthy Together, a randomized clinical trial examining the effect of a limited RED (non-nutrient-dense, energy-dense) food variety prescription delivered within an 18-month family-based behavioral obesity treatment (FBT) on body mass index (BMI) and habituation rate to RED foods. One hundred fifty-six children (ages: 8-12 y; BMI: ≥ 85th percentile-for-age) and a caregiver (BMI: ≥ 25 kg/m 2 ), both with overweight or obesity, will be randomized to one of two, interventions: FBT or FBT + Variety. All participants will receive 29 sessions of FBT and be prescribed the Traffic Light Diet (1000-1500 kcal/day, ≤ 2 RED food servings/day), and a physical activity goal (≥ 60 min/day [child] or 150 min/week [adult] of moderate-vigorous physical activity (MVPA)). FBT + Variety will also identify two RED foods, a dinner entrée and snack food, and develop meal plans that reduce variety of RED foods by regularly consuming these foods and limiting consumption of other RED foods. Measures of anthropometrics, dietary intake, habituation of salivary response to food cues, and physical activity will be assessed at 0, 6, 12, and 18-months. This study translates a line of basic behavioral research examining how dietary variety influences habituation into a dietary prescription that will be tested within an efficacy trial. It is hypothesized that a novel, limited dietary variety prescription within FBT should promote a faster food habituation rate, reducing energy intake and amplifying long-term weight loss in children.",2020,One hundred fifty-six children (ages: 8-12,"['family-based childhood obesity treatment', 'One hundred fifty-six children (ages: 8-12', 'y; BMI: ≥ 85th percentile-for-age) and a caregiver (BMI: ≥ 25\u202fkg/m 2 ), both with overweight or obesity', 'children']","['FBT or FBT\u202f+\u202fVariety', 'FBT and be prescribed the Traffic Light Diet', 'physical activity goal (≥ 60\u202fmin/day [child] or 150\u202fmin/week [adult] of moderate-vigorous physical activity (MVPA', 'limited RED (non-nutrient-dense, energy-dense) food variety prescription delivered within an 18-month family-based behavioral obesity treatment (FBT']","['anthropometrics, dietary intake, habituation of salivary response to food cues, and physical activity', 'body mass index (BMI) and habituation rate to RED foods']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332575', 'cui_str': 'Red color'}]",156.0,0.050562,One hundred fifty-six children (ages: 8-12,"[{'ForeName': 'Steve M', 'Initials': 'SM', 'LastName': 'Douglas', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Grace M', 'Initials': 'GM', 'LastName': 'Hawkins', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Kristoffer S', 'Initials': 'KS', 'LastName': 'Berlin', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Crouter', 'Affiliation': 'Department of Kinesiology, Recreation, and Sport Studies, University of Tennessee, Knoxville, TN, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, School of Medicine, and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital/Brown Alpert Medical School, Providence, RI, USA.'}, {'ForeName': 'Hollie A', 'Initials': 'HA', 'LastName': 'Raynor', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville, TN, USA. Electronic address: hraynor@vols.utk.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106153']
2322,32950650,The p Factor Consistently Predicts Long-Term Psychiatric and Functional Outcomes in Anxiety-Disordered Youth.,"OBJECTIVE


Pediatric anxiety disorders can have a chronic course and are considered gateway disorders to adult psychopathology, but no consistent predictors of long-term outcome have been identified. A single latent symptom dimension that reflects features shared by all mental health disorders, the p factor, is thought to reflect mechanisms that cut across mental disorders. Whether p predicts outcome in youth with psychiatric disorders has not been examined. We tested whether the p factor predicted long-term psychiatric and functional outcomes in a large naturalistically followed-up cohort of anxiety-disordered youth.
METHOD


Youth enrolled in a randomized controlled treatment trial of pediatric anxiety during childhood/adolescence were followed-up on average six years posttreatment and then annually for four years. Structural equation modeling was used to estimate p at baseline. p and previously established predictors were modeled as predictors of long-term outcome.
RESULTS


Higher levels of p at baseline were related to more mental health disorders, poorer functioning, and greater impairment across all measures at all follow-up time points. p predicted outcome above and beyond previously identified predictors, including diagnostic comorbidity at baseline. Post hoc analyses showed that p predicted long-term anxiety outcomes, but not acute treatment outcome, suggesting that p may be uniquely associated with long-term outcome.
CONCLUSION


Youth with anxiety disorders who present with a liability towards broad mental health problems may be at a higher risk for poor long-term outcome across mental health and functional domains. Efforts to assess and address this broad liability may enhance long-term outcome.",2020,"RESULTS


Higher levels of p at baseline were related to more mental health disorders, poorer functioning, and greater impairment across all measures at all follow-up time points.","['Youth with anxiety disorders', 'youth with psychiatric disorders', 'Youth enrolled']",[],"['mental health disorders, poorer functioning', 'diagnostic comorbidity']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",[],"[{'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",,0.0743218,"RESULTS


Higher levels of p at baseline were related to more mental health disorders, poorer functioning, and greater impairment across all measures at all follow-up time points.","[{'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Cervin', 'Affiliation': 'Lund University, Sweden. Electronic address: matti.cervin@med.lu.se.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Norris', 'Affiliation': 'Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Golda', 'Initials': 'G', 'LastName': 'Ginsburg', 'Affiliation': 'University of Connecticut School of Medicine, West Hartford, Connecticut.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Gosch', 'Affiliation': 'd Philadelphia College of Osteopathic Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Compton', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, California.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Albano', 'Affiliation': 'Columbia University, New York.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Sakolsky', 'Affiliation': 'University of Pittsburgh School of Medicine, Pennsylvania.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Birmaher', 'Affiliation': 'University of Pittsburgh School of Medicine, Pennsylvania.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Keeton', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Temple University, Philadelphia, Pennsylvania.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.08.440']
2323,32950737,"A pragmatic stepped-wedge cluster randomized trial to evaluate the effectiveness and cost-effectiveness of active case finding for household contacts within a routine tuberculosis program, San Juan de Lurigancho, Lima, Peru.","BACKGROUND


Active case finding (ACF) in household contacts of tuberculosis (TB) patients is now recommended for National TB Programs (NTP) in low- and middle-income countries. However, evidence supporting these recommendations remains limited. This study evaluates the effectiveness and cost-effectiveness of ACF for household contacts of TB cases in a large TB endemic district of Lima, Peru.
METHODS


A pragmatic stepped-wedge cluster randomized controlled trial was conducted in 34 health centers of San Juan de Lurigancho district. Centers were stratified by TB rate and randomly allocated to initiate ACF in groups of eight or nine centers at four-month intervals. In the intervention arm, NTP providers visited households of index patients to screen contacts for active TB. The control arm was routine passive case finding (PCF) of symptomatic TB cases. The primary outcomes were the crude and adjusted active TB case rates among household contacts. Program costs were directly measured, and the cost-effectiveness of the ACF intervention was determined.
FINDINGS


3,222 index TB cases and 12,566 household contacts were included in the study. ACF identified more household contact TB cases than PCF, 199·29/10,000 contacts/year vs. 132·13 (incidence rate ratio of 1·51 (95% CI 1·21 to 1·88)). ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
CONCLUSION


ACF of TB case household contacts detected significantly more secondary TB cases than PCF alone, but was not cost-effective in this setting. In threshold analyses, ACF becomes cost-effective if associated with case detection rates 2·5 times higher than existing PCF programs.",2020,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","['household contacts of tuberculosis (TB) patients', '34 health centers of San Juan de Lurigancho district', 'household contacts of TB cases in a large TB endemic district of Lima, Peru', '3,222 index TB cases and 12,566 household contacts were included in the study']","['PCF', 'ACF']","['effectiveness and cost-effectiveness', 'crude and adjusted active TB case rates among household contacts', 'Program costs']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.240111,"ACF was associated with an incremental cost-effectiveness ratio of US $16,400 per disability-adjusted life year averted and not cost-effective assuming a willingness-to-pay threshold for Peru of US $6,360.
","[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Rojas Peña', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Perú.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Mori', 'Affiliation': 'Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Perú.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zamudio', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Perú.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Kaufman', 'Affiliation': 'Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Otero', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Perú; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Perú.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Gotuzzo', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Perú; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Perú.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Seas', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Perú; Facultad de Medicina, Universidad Peruana Cayetano Heredia, Lima, Perú; Departamento de Enfermedades Infecciosas, Tropicales y Dermatológicas, Hospital Cayetano Heredia, Lima, Perú.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Brewer', 'Affiliation': 'Departments of Medicine and Epidemiology, David Geffen School of Medicine, Jonathan & Karin Fielding School of Public Health, University of California, Los Angeles, California, United States of America.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.09.034']
2324,32950748,Efficacy and Safety of Continued Treatment with Mirikizumab in a Phase 2 Trial of Patients with Ulcerative Colitis.,"BACKGROUND & AIMS


Mirikizumab is an antibody against the p19 subunit of interleukin 23 that has demonstrated clinical efficacy and was well tolerated following 12 weeks of induction treatment in a phase 2 trial of patients with moderate to severe ulcerative colitis. We present results of the open-label extended induction period in patients who did not initially respond to treatment with mirikizumab.
METHODS


This study was a continuation of I6T-MC-AMAC, a double-blind trial, performed at 75 sites in 14 countries, in which patients with moderate to severe ulcerative colitis were randomly assigned to 12 weeks induction therapy with 50 mg, 200 mg, or 600 mg mirikizumab or placebo. Patients without a clinical response (a 9-point decrease in Mayo subscore of ≥2 points and ≥35% from baseline and either a decrease of rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1) at week 12 were offered the opportunity participate in an open-label, extended induction study for another 12 weeks, in which they received either 600 mg intravenous mirikizumab (n=20) or, following a protocol amendment, 1000 mg intravenous mirikizumab (n=64) every 4 weeks. At week 24, patients with a clinical response continued the extension maintenance period and received 200 mg subcutaneous mirikizumab. Endpoints included clinical remission (Mayo subscores of 0 for rectal bleeding, 0 or 1 with a 1-point decrease from baseline), clinical response, endoscopic remission (Mayo endoscopic subscore of 0), or endoscopic improvement (endoscopic subscore of 0 or 1), at study weeks 24 and 52. Data were analysed for patients who received mirikizumab or placebo during the induction phase of the study.
RESULTS


Among participants who did not respond to induction mirikizumab, 50.0% of those who received the 12-week extension of 600 mg mirikizumab and 43.8% who the extension of 1000 mg mirikizumab achieved a clinical response; 15.0% and 9.4% achieved clinical remission, respectively. Endoscopic improvement was achieved by 20.0% of subjects in the 600 mg mirikizumab group and 15.6% subjects in the 1000 mg mirikizumab group. Among initial nonresponders to mirikizumab who had clinical response at study week 24 and continued into maintenance therapy, 65.8% maintained the clinical response, 26.3% achieved clinical remission, and 34.2% had endoscopic improvement at week 52. No new safety concerns were identified.
CONCLUSIONS


Extended doses of mirikizumab (600 mg and 1000 mg) for an additional 12 weeks produce a clinical response in up to 50% of patients who did not have a clinical response to 12 weeks of induction doses (50 mg, 200 mg, or 600 mg). Most of the responders to the extended doses maintained clinical response for up to 52 weeks.",2020,Endoscopic improvement was achieved by 20.0% of subjects in the 600 mg mirikizumab group and 15.6% subjects in the 1000 mg mirikizumab group.,"['Patients with Ulcerative Colitis', '75 sites in 14 countries, in which patients with moderate to severe ulcerative colitis', 'patients with moderate to severe ulcerative colitis', 'patients who did not initially respond to treatment with mirikizumab']","['mirikizumab or placebo', '200 mg subcutaneous mirikizumab', 'mirikizumab', 'I6T-MC-AMAC', 'Mirikizumab']","['Mayo subscore', 'clinical response', 'clinical remission', 'Efficacy and Safety', 'endoscopic improvement', 'Endoscopic improvement', 'rectal bleeding subscore of ≥1 or a rectal bleeding subscore', 'clinical remission (Mayo subscores of 0 for rectal bleeding, 0 or 1 with a 1-point decrease from baseline), clinical response, endoscopic remission (Mayo endoscopic subscore of 0), or endoscopic improvement (endoscopic subscore of 0 or 1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0993855,Endoscopic improvement was achieved by 20.0% of subjects in the 600 mg mirikizumab group and 15.6% subjects in the 1000 mg mirikizumab group.,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University California San Diego, La Jolla, CA, United States. Electronic address: wsandborn@ucsd.edu.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ferrante', 'Affiliation': 'Universitair Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'Bal R', 'Initials': 'BR', 'LastName': 'Bhandari', 'Affiliation': 'Delta Research Partners, Bastrop, LA, United States.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Berliba', 'Affiliation': 'Arsenia EM, Chisinau, Moldova (the Republic of).'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Kitasato Institute Hospital Center for Advanced IBD Research and Treatment, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Tuttle', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Krueger', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Friedrich', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Durante', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Vipin', 'Initials': 'V', 'LastName': 'Arora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'April N', 'Initials': 'AN', 'LastName': 'Naegeli', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schmitz', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, United States.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Western University, Robarts Clinical Trials Inc, London, ON, Canada.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.09.028']
2325,32950763,Stress-induced modulation of multiple memory systems during retrieval requires noradrenergic arousal.,"Stress has been shown to favor dorsal striatum-dependent 'habit' memory over hippocampus-dependent 'cognitive' memory during learning. Here, we investigated whether stress may modulate the engagement of these 'cognitive' and 'habit' systems also during memory retrieval and if so, whether such a stress-induced shift in the control of memory retrieval depends on noradrenergic activation. To this end, participants acquired a probabilistic classification learning (PCL) task that can be solved by both the 'cognitive' and the 'habit' system, reflected in the distinct behavioral strategies. Twenty-four hours later, participants received either the beta-adrenergic receptor antagonist propranolol or a placebo before they underwent a psychosocial stressor or a non-stressful control manipulation, followed by a retrieval version of the PCL task. Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory. Stressed participants that had received a placebo fell back to a 'cognitive' strategy during retrieval, which was linked to an impairment in retrieval performance. Propranolol blocked this stress-induced shift towards the less efficient strategy. Moreover, our results showed that salivary cortisol was related to the retrieval strategy only when paralleled by increased autonomic arousal. Together, these results indicate that stress effects on the modulation of multiple memory system during retrieval necessitate noradrenergic arousal, with relevant implications for retrieval performance under stress.",2020,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.",[],"['Propranolol', 'placebo', 'beta-adrenergic receptor antagonist propranolol or a placebo']","['autonomic arousal', 'salivary cortisol']",[],"[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}]","[{'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0560178,"Overall, participants showed a practice-dependent shift from 'cognitive' to 'habit' memory.","[{'ForeName': 'Gundula', 'Initials': 'G', 'LastName': 'Zerbes', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Franziska Magdalena', 'Initials': 'FM', 'LastName': 'Kausche', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany.'}, {'ForeName': 'Jana Christina', 'Initials': 'JC', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry, University Clinic Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Schwabe', 'Affiliation': 'Department of Cognitive Psychology, University of Hamburg, Germany. Electronic address: lars.schwabe@uni-hamburg.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104867']
2326,32950829,Effects of perioperative magnesium sulfate with controlled hypotension on intraoperative bleeding and postoperative ecchymosis and edema in open rhinoplasty.,"PURPOSE


This randomized, double-blind study was planned to evaluate the effect of perioperative magnesium sulfate with controlled hypotension on intraoperative bleeding, postoperative ecchymosis and edema, and side-effects.
MATERIALS AND METHOD


Forty-nine patients undergoing open rhinoplasty were divided into two groups - magnesium sulfate and control. The magnesium sulfate group received 30-50 mg·kg -1  intravenously as a bolus before induction of anesthesia, followed by 10-20 mg·kg -1  h -1  by continuous intravenous infusion during surgery. Anesthesia was induced with propofol 3 mg·kg -1 , fentanyl 15 μg·kg -1  and cisatracurium 0.6 mg·kg -1 . Mean arterial pressure was maintained at 50 to 60 mmHg under controlled hypotensive anesthesia with magnesium sulfate titration. Hemodynamic variables, operational bleeding, early postoperative side-effects and postoperative first-, third- and seventh-day ecchymosis and edema were compared between the groups. Ecchymosis and edema were evaluated using a graded scale from 0 to 4.
RESULTS


In the magnesium sulfate group, mean arterial pressure decreased during most of the perioperative period. Intraoperative bleeding also decreased. A distinct reduction in ecchymosis and edema was observed in both the upper and lower eyelids on the first, third and seventh days. Patients in the magnesium sulfate group also had a more peaceful postoperative course with less postoperative nausea vomiting, and shivering.
CONCLUSION


Magnesium sulfate with controlled hypotension can lower ecchymosis and edema of the upper and lower eyelids in rhinoplasty surgery by reducing bleeding.",2020,"Patients in the magnesium sulfate group also had a more peaceful postoperative course with less postoperative nausea vomiting, and shivering.
",['Forty-nine patients undergoing open rhinoplasty'],"['propofol 3\xa0mg·kg -1 , fentanyl 15\xa0μg·kg -1  and cisatracurium 0.6\xa0mg·kg -1 ', 'magnesium sulfate titration', 'magnesium sulfate and control', 'perioperative magnesium sulfate with controlled hypotension', 'Magnesium sulfate with controlled hypotension', 'magnesium sulfate']","['Hemodynamic variables, operational bleeding, early postoperative side-effects and postoperative first-, third- and seventh-day ecchymosis and edema', 'intraoperative bleeding and postoperative ecchymosis and edema', 'postoperative nausea vomiting, and shivering', 'intraoperative bleeding, postoperative ecchymosis and edema, and side-effects', 'ecchymosis and edema', 'Ecchymosis and edema', 'Mean arterial pressure', 'Intraoperative bleeding', 'mean arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0396086', 'cui_str': 'Open rhinoplasty'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020650', 'cui_str': 'Induced hypotension'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0036973', 'cui_str': 'Shivering or rigors'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",49.0,0.0351178,"Patients in the magnesium sulfate group also had a more peaceful postoperative course with less postoperative nausea vomiting, and shivering.
","[{'ForeName': 'Muge', 'Initials': 'M', 'LastName': 'Kosucu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anesthesiology, 61080 Trabzon, Turkey. Electronic address: mugekk73@hotmail.com.'}, {'ForeName': 'Ersagun', 'Initials': 'E', 'LastName': 'Tugcugil', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anesthesiology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Neurosurgery, 61080 Trabzon, Turkey.'}, {'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Omur', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anesthesiology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Livaoglu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Plastic and Reconstructive Surgery, 61080 Trabzon, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102722']
2327,32958371,Long-term BAROS scores and independent obesity-related co-morbidity predictors of failure after laparoscopic Roux-en-Y gastric bypass.,"BACKGROUND


Long-term (>5 yr) studies assessing outcomes after laparoscopic Roux-en-Y gastric bypass (LRYGB) using the Bariatric Analysis and Reporting Outcome System (BAROS) are limited. Evidence of predictors of failure long-term after LRYGB is also lacking.
OBJECTIVES


To compare BAROS scores at 5 and 10 years post LRYGB and to establish whether individual obesity-related co-morbidities are associated with suboptimal outcomes at these time points.
SETTING


Single bariatric unit.
METHODS


BAROS scores were analyzed in patients who were 5 years (group A) and 10 years (group B) post LRYGB. Obesity-related co-morbidities as predictors of failure of surgery (defined by % excess weight loss [%EWL] <50% or BAROS total score ≤1) were examined. Intergroup comparative analysis of outcomes and logistic regression modeling to determine predictors of weight loss failure were conducted.
RESULTS


A total of 88 patients were 5 years post LRYGB (group A), and 91 patients were 10 years post LRYGB (group B). A total of 52.3% (46/88) in group A and 54.9% (50/91) in group B had failure of weight loss defined by %EWL <50%. There were no significant differences in percentage of total weight loss, %EWL, or BAROS scores between the 2 groups (21.8% versus 22.0%, P = .897; 48.5% versus 47.1%, P = .993; and 3.7 versus 3.3, P = .332, respectively). No individual obesity-related co-morbidity at time of surgery was associated with suboptimal outcomes (%EWL <50% or BAROS total score ≤1) at 5 years or 10 years after LRYGB.
CONCLUSIONS


Long-term outcomes assessed by the BAROS score appear sustainable between 5 and 10 years after LRYGB surgery, and weight loss achieved at 5 years is maintained at 10 years. Preoperative presence of specific obesity-related co-morbidities was not associated with failure of surgery long-term.",2020,"There were no significant differences in percentage of total weight loss, %EWL, or BAROS scores between the 2 groups (21.8% versus 22.0%, P = .897; 48.5% versus 47.1%, P = .993; and 3.7 versus 3.3, P = .332, respectively).","['88 patients were 5 years post LRYGB (group A), and 91 patients were 10 years post LRYGB (group B', 'patients who were 5 years (group A) and 10 years (group B) post LRYGB', 'Single bariatric unit']","['laparoscopic Roux-en-Y gastric bypass (LRYGB', 'laparoscopic Roux-en-Y gastric bypass']","['failure of weight loss', 'weight loss', 'BAROS scores', 'individual obesity-related co-morbidity', 'percentage of total weight loss, %EWL, or BAROS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",88.0,0.0327004,"There were no significant differences in percentage of total weight loss, %EWL, or BAROS scores between the 2 groups (21.8% versus 22.0%, P = .897; 48.5% versus 47.1%, P = .993; and 3.7 versus 3.3, P = .332, respectively).","[{'ForeName': 'Krashna', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Department of Upper GI and Bariatric Surgery, Luton and Dunstable University Hospital, Luton, United Kingdom. Electronic address: krashna@doctors.org.uk.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Askari', 'Affiliation': 'Department of Upper GI and Bariatric Surgery, Luton and Dunstable University Hospital, Luton, United Kingdom.'}, {'ForeName': 'Ravikrishna', 'Initials': 'R', 'LastName': 'Mamidanna', 'Affiliation': 'Department of Upper GI and Bariatric Surgery, Luton and Dunstable University Hospital, Luton, United Kingdom.'}, {'ForeName': 'Vigyan', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Department of Upper GI and Bariatric Surgery, Luton and Dunstable University Hospital, Luton, United Kingdom.'}, {'ForeName': 'Tanveer', 'Initials': 'T', 'LastName': 'Adil', 'Affiliation': 'Department of Upper GI and Bariatric Surgery, Luton and Dunstable University Hospital, Luton, United Kingdom.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.07.037']
2328,32958377,Effect of motor imagery on enjoyment in knee-injury prevention and rehabilitation training: A randomized crossover study.,"OBJECTIVES


The novel MOTor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS) model takes a uniquely holistic approach by integrating mental and physical aspects into current training programs. The aim of this trial was to evaluate enjoyment of MOTIFS training as compared to Care-as-Usual (CaU) knee injury and/or rehabilitation training. The primary hypothesis was that enjoyment would be greater following MOTIFS training than CaU training.
DESIGN


Block-randomized 2×2 cross-over trial.
METHODS


Thirty athletes (18-31years, 50% women) currently or previously active in team ball sports, with no pain or injury preventing jump and/or directional changes. MOTIFS training integrates sport-specific experiences and equipment into physical exercises to increase individualized realism and meaning. The CaU condition included solely physical exercise. The main outcome was the Physical Activity Enjoyment Scale (PACES). Secondary outcomes included Self-Assessment Manikin (SAM; subscales Valence, Arousal, Dominance), Perceived exertion, pulse, duration, and movement quality.
RESULTS


PACES scores were better following MOTIFS training than CaU (point estimate 24.67; 95% CI: 19.0; 30.3). Between-groups differences in SAM Valence (median 2, quartiles 1;3), Arousal (median 1, quartiles 0;2.25), and Dominance (median 0.5, quartiles 0;2), and RPE (median 1, quartiles -0.3;2), training duration (mean 5.34, 95% CI: -0.17; -0.73), and pulse (median 7.50, quartiles 0.25;16.75) were higher following MOTIFS training than CaU training.
CONCLUSIONS


Results suggest that the MOTIFS model, which integrates simultaneous physical and psychological interventions, is a clinically plausible method of influencing enjoyment and other psychological outcomes. Further studies may explore effects of the MOTIFS principles on injury prevention and rehabilitation training.",2020,"RESULTS


PACES scores were better following MOTIFS training than CaU (point estimate 24.67; 95% CI: 19.0; 30.3).","['Thirty athletes (18-31years, 50% women) currently or previously active in team ball sports, with no pain or injury preventing jump']","['Care-as-Usual (CaU) knee injury and/or rehabilitation training', 'motor imagery', 'MOTIFS training']","['SAM Valence', 'training duration', 'Self-Assessment Manikin (SAM; subscales Valence, Arousal, Dominance), Perceived exertion, pulse, duration, and movement quality', 'Physical Activity Enjoyment Scale (PACES', 'RPE']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]","[{'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",30.0,0.0946022,"RESULTS


PACES scores were better following MOTIFS training than CaU (point estimate 24.67; 95% CI: 19.0; 30.3).","[{'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Cederström', 'Affiliation': 'Department of Health Sciences, Lund University, Sweden. Electronic address: niklas.cederstrom@med.lu.se.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Granér', 'Affiliation': 'Department of Psychology, Lund University, Sweden.'}, {'ForeName': 'Gustav', 'Initials': 'G', 'LastName': 'Nilsson', 'Affiliation': 'Malmö Idrottsklinik, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ageberg', 'Affiliation': 'Department of Health Sciences, Lund University, Sweden.'}]",Journal of science and medicine in sport,['10.1016/j.jsams.2020.09.004']
2329,32958408,High-intensity interval training in patients with left ventricular assist devices: A pilot randomized controlled trial.,"BACKGROUND


Left ventricular assist device (LVAD) implantation is an established treatment for patients with advanced heart failure. To date, studies evaluating the impact of aerobic training in patients with LVADs have focused on moderate-intensity exercise.
METHODS


This pilot randomized controlled trial compared the effects of high-intensity interval training (HIIT) with those of moderate-intensity continuous training (MICT) on peak oxygen consumption (V̇O 2  peak) in patients with LVADs. Secondary outcomes included 6-minute walk test distance, flow-mediated dilation, and anthropometry. Assessments were conducted at baseline and after 12 weeks of supervised training performed 3 times weekly. Participants were randomized to HIIT (4 sets of 4 minutes at 80%-90% V̇O 2  reserve, alternating with 3 minutes at 50%-60% V̇O 2  reserve) or MICT groups (28 minutes continuously at 50%-60% V̇O 2  reserve). Within and between-group differences were analyzed using linear mixed models. Data are expressed as marginal means with 95% confidence intervals or as mean ± SD.
RESULTS


A total of 21 participants were randomized (HIIT: age 57.7 ± 13.1 years; n = 11 and MICT: age 55.6 ± 14.2 years; n = 10) (mean ± SD). No major adverse events occurred in response to training in either group. HIIT significantly improved V̇O 2  peak (15.6 [13.2-17.8] to 18.4 [16.0-20.8] ml/kg/min) (marginal mean [95% CI]) compared with MICT (16.2 [13.8-18.7] to 17.2 [14.6-19.7] ml/kg/min; p < 0.05 between groups). No significant group differences were detected in secondary outcomes.
CONCLUSION


In patients with LVADs, HIIT was well tolerated and increased aerobic capacity more than MICT. These preliminary findings support the prescription of high-intensity exercise in clinically stable patients with LVADs but warrant validation in a larger sample and across a broader range of physiologic and clinical outcomes.
CLINICAL TRIAL REGISTRATION


URL: https://www.anzctr.org.au, unique identifier: ACTRN12616001596493.",2020,HIIT significantly improved V̇O 2  peak (15.6 [13.2-17.8] to 18.4 [16.0-20.8] ml/kg/min) (marginal mean [95% CI]) compared with MICT (16.2 [13.8-18.7] to 17.2 [14.6-19.7] ml/kg/min; p < 0.05 between groups).,"['patients with advanced heart failure', 'A total of 21 participants were randomized (HIIT: age 57.7 ± 13.1 years; n\u202f=\u202f11 and MICT: age 55.6 ± 14.2 years; n\u202f=\u202f10) (mean ± SD', 'patients with left ventricular assist devices', 'patients with LVADs']","['MICT', 'Left ventricular assist device (LVAD) implantation', 'High-intensity interval training', 'aerobic training', 'high-intensity interval training (HIIT) with those of moderate-intensity continuous training (MICT']","['peak oxygen consumption (V̇O 2  peak', '6-minute walk test distance, flow-mediated dilation, and anthropometry', 'adverse events', 'tolerated and increased aerobic capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",21.0,0.283557,HIIT significantly improved V̇O 2  peak (15.6 [13.2-17.8] to 18.4 [16.0-20.8] ml/kg/min) (marginal mean [95% CI]) compared with MICT (16.2 [13.8-18.7] to 17.2 [14.6-19.7] ml/kg/min; p < 0.05 between groups).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Scheer', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Lam', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Spence', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hayward', 'Affiliation': ""Heart Failure and Transplant Unit, Victor Chang Cardiac Research Institute, St Vincent's Hospital, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kaye', 'Affiliation': 'Heart Failure Research Group, Baker Heart and Diabetes Institute, Melbourne, Australia; Department of Cardiology, The Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Leet', 'Affiliation': 'Department of Cardiology, The Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Fuller', 'Affiliation': 'Department of Cardiology, The Alfred Hospital, Melbourne, Australia; School of Health Sciences, Swinburne University, Melbourne, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Perth, Australia; Cardiovascular Research Group, School of Human Sciences (Exercise and Sport Science), University of Western Australia, Perth, Australia; Allied Health Department, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'Cardiovascular Research Group, School of Human Sciences (Exercise and Sport Science), University of Western Australia, Perth, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia; Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Perth, Australia; Allied Health Department, Fiona Stanley Hospital, Perth, Australia. Electronic address: Andrew.Maiorana@health.wa.gov.au.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.08.005']
2330,32958584,A Randomized Controlled Trial on Efficacy of Surgical Excision of non-dysplastic Leukoplakia to Prevent Oral Cancer.,"The aim of this study was to evaluate the effectiveness of surgical excision to prevent cancer in patients with non-dysplastic oral leukoplakia (OL). This study was the first randomized controlled clinical trial comparing surgical treatment with standard care in this group of patients. Patients were divided into two groups. The first group underwent standard care, i.e. smoking counseling, follow-up visits every six months, and control biopsy when indicated. The second group underwent surgical excision, together with standard care. Oral cancer onset was the primary outcome; secondary outcomes included healing, recurrence after surgery, onset of new lesions, and worsening of the primary lesions. The differences in distribution of the patients' and lesions' characteristics were investigated through non-parametrical tests (Wilcoxon Rank-Sum and Fisher's Exact). Univariate and multivariate logistic regressions have been performed in order to estimate the Odds Ratio of the treatment on the recurrence or worsening of the lesions. A total of 260 patients took part in the study of which 132 were women (50.8%); during the follow-up period, two subjects developed oral cancer, one for each arm. Surgical treatment, when compared with standard care, was associated with a lower probability of the treated zone to remain healed during the follow up period (OR = 7.43; 95% CI=2.96-22.66). In conclusion, it is possible to assumed that regular clinical follow-up could be considered a reliable standard of care among patients with non-dysplastic OLs.",2020,"Surgical treatment, when compared with standard care, was associated with a lower probability of the treated zone to remain healed during the follow up period (OR = 7.43; 95% CI=2.96-22.66).","['260 patients took part in the study of which 132 were women (50.8%); during the follow-up period, two subjects developed oral cancer, one for each arm', 'patients with non-dysplastic OLs', 'patients with non-dysplastic oral leukoplakia (OL']","['surgical excision, together with standard care', 'surgical excision', 'Surgical Excision of non-dysplastic Leukoplakia']","['lower probability of the treated zone to remain healed', 'healing, recurrence after surgery, onset of new lesions, and worsening of the primary lesions']","[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0399474', 'cui_str': 'Dysplastic oral leukoplakia'}, {'cui': 'C0023532', 'cui_str': 'Leukoplakia of oral mucosa'}]","[{'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0023531', 'cui_str': 'Leukoplakia'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",260.0,0.0365848,"Surgical treatment, when compared with standard care, was associated with a lower probability of the treated zone to remain healed during the follow up period (OR = 7.43; 95% CI=2.96-22.66).","[{'ForeName': 'Paolo G', 'Initials': 'PG', 'LastName': 'Arduino', 'Affiliation': 'Surgical Sciences, University of Turin paologiacomo.arduino@unito.it.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lodi', 'Affiliation': 'Scienze Biomediche, Chirurgiche e Odontoiatriche, Università degli Studi di Milano.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cabras', 'Affiliation': 'Surgical Sciences, University of Turin.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Macciotta', 'Affiliation': 'Polytechnic University of Turin.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Gambino', 'Affiliation': 'Surgical Sciences, University of Turin.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Conrotto', 'Affiliation': 'Surgical Sciences, University of Turin.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Karimi', 'Affiliation': 'Surgical Sciences, University of Turin.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'El Haddad', 'Affiliation': 'Surgical Sciences, University of Turin.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Carbone', 'Affiliation': 'Surgical Sciences, University of Turin.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Broccoletti', 'Affiliation': 'Surgical Sciences, University of Turin.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0234']
2331,32958697,Association of elevated hs-CRP and multiple infarctions with outcomes of minor stroke or TIA: subgroup analysis of CHANCE randomised clinical trial.,"BACKGROUND AND PURPOSE


The relationship of high-sensitive C-reactive protein (hs-CRP) levels and infarction numbers with the prognosis of stroke is uncertain. This study evaluated the association of different hs-CRP levels and infarction numbers with the prognosis of acute minor ischaemic stroke or transient ischaemic attack (TIA).
METHODS


A subset of 807 patients with both hs-CRP measurement and baseline MRI was included from the Clopidogrel in High-risk Patients with Acute Non-disabling Cerebrovascular Events trial. The primary efficacy outcome was the occurrence of an ischaemic stroke at the 1-year follow-up. Infarction numbers were classified as multiple acute infarctions (MAIs), single acute infarction and no acute infarction (NAI). The association between different hs-CRP levels with different infarction numbers and the risk of any outcome was analysed using multivariable Cox regression models.
RESULTS


Among the 807 patients, 84 (10.4%) patients had a recurrent ischaemic stroke within 1 year. After adjustment for conventional confounding factors, patients with both elevated hs-CRP levels and MAIs were associated with approximately 4.7-fold of risk of ischaemic stroke within 1 year (16.7% vs 3.5%, HR 4.68, 95% CI 1.54 to 14.23, p=0.007), compared with those with non-elevated hs-CRP levels and NAI. Similar results were observed for the composite events.
CONCLUSIONS


Combined elevated hs-CRP levels and MAIs may increase 1-year stroke risk stratification efficiency in patients with minor ischaemic stroke or TIA compared with using those markers alone, which indicated that the combination of inflammatory and imaging markers might improve the effectiveness of risk stratification concerning minor ischaemic stroke or TIA.ClinicalTrials.gov Registry (NCT00979589).",2020,"Combined elevated hs-CRP levels and MAIs may increase 1-year stroke risk stratification efficiency in patients with minor ischaemic stroke or TIA compared with using those markers alone, which indicated that the combination of inflammatory and imaging markers might improve the effectiveness of risk stratification concerning minor ischaemic stroke or TIA.ClinicalTrials.gov Registry (NCT00979589).","['patients with minor ischaemic stroke or TIA', '807 patients with both hs-CRP measurement and baseline MRI was included from the']",['Clopidogrel'],"['recurrent ischaemic stroke', 'multiple acute infarctions (MAIs), single acute infarction and no acute infarction (NAI', 'ischaemic stroke', '1-year stroke risk stratification efficiency', 'occurrence of an ischaemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",807.0,0.331491,"Combined elevated hs-CRP levels and MAIs may increase 1-year stroke risk stratification efficiency in patients with minor ischaemic stroke or TIA compared with using those markers alone, which indicated that the combination of inflammatory and imaging markers might improve the effectiveness of risk stratification concerning minor ischaemic stroke or TIA.ClinicalTrials.gov Registry (NCT00979589).","[{'ForeName': 'Guangyao', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiejie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'Wang', 'Affiliation': ""Neurovascular Division, Department of Neurology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China yilong528@gmail.com yongjunwang@ncrcnd.org.cn.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China yilong528@gmail.com yongjunwang@ncrcnd.org.cn.'}]",Stroke and vascular neurology,['10.1136/svn-2020-000369']
2332,32958699,Genomic analysis of germline variation associated with survival of colorectal cancer patients treated with chemotherapy plus biologics in CALGB/SWOG 80405 (Alliance).,"BACKGROUND


Irinotecan/5-FU (FOLFIRI) or oxaliplatin/5-FU (FOLFOX), combined with bevacizumab or cetuximab, are approved, first-line treatments for metastatic colorectal cancer (mCRC). We aimed at identifying germline variants associated with survival in mCRC patients treated with these regimens in CALGB/SWOG 80405.
METHODS


Patients with mCRC receiving either FOLFOX or FOLFIRI were randomized to either cetuximab or bevacizumab. DNA from peripheral blood was genotyped for ~700,000 single-nucleotide polymorphisms (SNPs). The association between SNPs and overall survival (OS) was tested in 613 patients of genetically-estimated European ancestry using Cox proportional hazards models.
RESULTS


The four most significant SNPs associated with OS were three haplotypic SNPs between MGST1 and LMO3 (representative hazard ratios (HR) 1.56, p-value 1.30x10-6), and rs11644916 in AXIN1 (HR 1.39, p-value 4.26x10-6). AXIN1 is a well-established tumor suppressor gene in CRC, and rs11644916 (G>A) conferred shorter OS. Median OS for patients with the AA, AG or GG genotypes was 18.4, 25.6, or 36.4 months, respectively. In 90 stage IV CRC patients from TCGA, rs11649255 in AXIN1 (in almost complete linkage disequilibrium (LD) with rs11644916), was associated with shorter OS (HR 2.24, p-value 0.0096). Using rs11648673 in AXIN1 (in very high LD with rs11644916 and with functional evidence), luciferase activity in three CRC cell lines was reduced.
CONCLUSIONS


This is the first large GWAS ever conducted in mCRC patients treated with first-line standard treatment in a randomized phase III trial. A common SNP in AXIN1 confers worse OS and the effect is replicated in TCGA. Further studies in CRC experimental models are required.",2020,"Median OS for patients with the AA, AG or GG genotypes was 18.4, 25.6, or 36.4 months, respectively.","['colorectal cancer patients treated with chemotherapy plus biologics in CALGB/SWOG 80405', 'metastatic colorectal cancer (mCRC', 'Patients with mCRC receiving either FOLFOX or FOLFIRI', '613 patients of genetically-estimated European ancestry using Cox proportional hazards models']","['Irinotecan/5-FU (FOLFIRI) or oxaliplatin/5-FU (FOLFOX), combined with bevacizumab or cetuximab', 'cetuximab or bevacizumab']","['shorter OS', 'SNPs and overall survival (OS', 'haplotypic SNPs between MGST1 and LMO3 (representative hazard ratios (HR', 'Median OS']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0010235', 'cui_str': 'Cox Proportional Hazards Models'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0360402,"Median OS for patients with the AA, AG or GG genotypes was 18.4, 25.6, or 36.4 months, respectively.","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': 'Eshelman School of Pharmacy, University of North Carolina at Chapel Hill innocent@unc.edu.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Sibley', 'Affiliation': 'Duke Cancer Institute, Duke University.'}, {'ForeName': 'Sushant A', 'Initials': 'SA', 'LastName': 'Patil', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Etheridge', 'Affiliation': 'Eshelman School of Pharmacy, Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Duke Cancer Institute.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Plummer', 'Affiliation': 'Center for Public Health Genomics, University of Virginia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Casey', 'Affiliation': 'Department of Public Health Sciences, University of Virginia.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital.""}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'McLeod', 'Affiliation': 'Precision Medicine, USF Taneja College of Pharmacy.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Auman', 'Affiliation': 'Pathology and Lab Medicine, UNC at Chapel Hill.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Furukawa', 'Affiliation': 'Division of Clinical Genome Research.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Kubo', 'Affiliation': 'Core for Genomic Medicine, RIKEN Center for Integrative Medical Sciences.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Norris Comprehensive Cancer Center, University of Southern California.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Parker', 'Affiliation': 'Genetics, University of North Carolina School of Medicine.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'Department of Medicine, Committee on Clinical Pharmacology and Pharmacogenomics, Comprehensive Cancer Center, University of Chicago.'}, {'ForeName': 'Kouros', 'Initials': 'K', 'LastName': 'Owzar', 'Affiliation': 'Biostatistics and Bioinformatics, Duke University.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2021']
2333,32958702,Early intervention with lenalidomide in patients with high-risk chronic lymphocytic leukemia.,"PURPOSE


Infectious complications constitute a leading cause of morbidity and mortality in chronic lymphocytic leukemia (CLL). Patients respond poorly to vaccines, particularly pneumococcal polysaccharide and influenza vaccines. Additionally, patients with genetically high risk disease are at increased risk for early disease progression and death. Lenalidomide, an oral immunomodulatory agent with demonstrated clinical activity in CLL, can potentially restore immune system dysfunction associated with CLL while improving disease outcomes.
EXPERIMENTAL DESIGN


Phase 2 study randomized 49 patients with genetically high-risk CLL or SLL (defined as unmutated IGHV, deletion(17p) or (11q), and/or complex abnormal karyotype), to receive lenalidomide either concurrent (Arm A) or sequential to (Arm B) 2 doses of 13-valent protein-conjugated pneumococcal vaccine (PCV13) administered 2 months apart, in patients not meeting IWCLL treatment criteria.
RESULTS


Four serotypes (3, 4, 5, 6B) achieved the additional seroprotection definition of a 4-fold increase in arm A, and 6 serotypes (3, 4, 5, 6B, 19A, 19F) in arm B. All patients achieved the defined concentration of 0.35ug/ml for at least one serotype tested. No significant difference was observed with the addition of lenalidomide. At median time on treatment of 3.6 years, median PFS was 5.8 years (95% CI 3.1-NR). PFS at 1, 2 and 3 year was 85% (95% CI 72-93), 79% (64-88), and 72% (95% CI 57-83) respectively.
CONCLUSION


Lenalidomide is efficacious with manageable toxicities as an early intervention strategy in patients with high-risk CLL, but did not enhance humoral response to PCV13 vaccine. This trial was registered with ClinicalTrials.gov Identifier: NCT01351896.",2020,"PFS at 1, 2 and 3 year was 85% (95% CI 72-93), 79% (64-88), and 72% (95% CI 57-83) respectively.
","['chronic lymphocytic leukemia (CLL', '49 patients with genetically high-risk CLL or SLL (defined as unmutated IGHV, deletion(17p) or (11q), and/or complex abnormal karyotype', 'patients with high-risk chronic lymphocytic leukemia', 'patients with high-risk CLL', 'patients with genetically high risk disease']","['lenalidomide', 'lenalidomide either concurrent (Arm A) or sequential to (Arm B) 2 doses of 13-valent protein-conjugated pneumococcal vaccine (PCV13', 'Lenalidomide']","['risk for early disease progression and death', 'additional seroprotection definition', 'PFS', 'median PFS']","[{'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0855095', 'cui_str': 'Malignant lymphoma, small lymphocytic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0476431', 'cui_str': 'Karyotype evaluation abnormal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",49.0,0.160773,"PFS at 1, 2 and 3 year was 85% (95% CI 72-93), 79% (64-88), and 72% (95% CI 57-83) respectively.
","[{'ForeName': 'Shanmugapriya', 'Initials': 'S', 'LastName': 'Thangavadivel', 'Affiliation': 'EHL, The Ohio State University.'}, {'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Comprehensive Cancer Center, Ohio State University.'}, {'ForeName': 'Narendranath', 'Initials': 'N', 'LastName': 'Epperla', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Rike', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University Wexner Medical Center.'}, {'ForeName': 'Xiaokui', 'Initials': 'X', 'LastName': 'Mo', 'Affiliation': 'Center for Biostatistics, Ohio State University.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Badawi', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center.'}, {'ForeName': 'Darlene', 'Initials': 'D', 'LastName': 'Bystry', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center.'}, {'ForeName': 'Mitch A', 'Initials': 'MA', 'LastName': 'Phelps', 'Affiliation': 'Arthur G. James Comprehensive Cancer Center and Solove Research Institute, College of Pharmacy, Ohio State University.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Andritsos', 'Affiliation': 'Department of Internal Medicine, Ohio State University.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Rogers', 'Affiliation': 'Division of Hematology, Ohio State University.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Hematology, The Ohio State University Comprehensive Cancer Center.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Woyach', 'Affiliation': 'Division of Hematology, Department of Medicine, The Ohio State University.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Division of Hematology, Department of Medicine, The Ohio State University Medical School.'}, {'ForeName': 'Farrukh T', 'Initials': 'FT', 'LastName': 'Awan', 'Affiliation': 'Internal Medicine, The University of Texas Southwestern Medical Center farrukh.awan@utsouthwestern.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1280']
2334,32959203,Effectiveness of an intensive care unit family education intervention on delirium knowledge: a pre-test post-test quasi-experimental study.,"PURPOSE


To create, validate, and refine an intensive care unit (ICU) delirium education intervention to prepare family members to partner with the ICU care team to detect delirium symptoms and prevent and manage delirium using nonpharmacological strategies.
METHODS


In this pre-test post-test quasi-experimental study, consecutive eligible family members of critically ill patients admitted to an ICU completed an ICU Family Education Delirium intervention in two parts: 1) six-minute video on ICU delirium (risk factors, prevention/management, symptoms, communication with the ICU care team), and 2) two case vignettes to practice detecting delirium using family-administered delirium detection questionnaires (Family Confusion Assessment Method [FAM-CAM] and Sour Seven). Family members' delirium knowledge was measured before, immediately after, and two weeks following the intervention using the Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ).
RESULTS


Of 99 family members recruited over eight months, 81 (82%) completed the intervention and 63 (63/81, 78%) completed all follow-up questionnaires. Family members' delirium knowledge improved significantly following the intervention (pre-CIDKQ, 14; 95% confidence interval [CI], 13 to 15; post-CIDKQ, 17; 95% CI, 16 to 17; P < 0.001) and was retained two weeks after the intervention (CIDKQ 16; 95% CI, 16 to 17; P < 0.001). This included increased knowledge regarding delirium risk factors (e.g., medication, mechanical ventilation), prevention/management (e.g., orientation, day/night routine), and symptoms of delirium. More family members correctly detected delirium symptoms in case vignettes using the Sour Seven (92%) compared with the FAM-CAM (78%).
CONCLUSIONS


A video-based ICU delirium education intervention is effective in educating family members about prevention, detection, and management of delirium.",2020,"More family members correctly detected delirium symptoms in case vignettes using the Sour Seven (92%) compared with the FAM-CAM (78%).
","['Of 99 family members recruited over eight months, 81 (82%) completed the intervention and 63 (63/81, 78%) completed all follow-up questionnaires', 'consecutive eligible family members of critically ill patients admitted to an ICU completed an ICU Family Education Delirium intervention in two parts: 1']","['intensive care unit (ICU) delirium education intervention', 'video-based ICU delirium education intervention', 'six-minute video on ICU delirium (risk factors, prevention/management, symptoms, communication with the ICU care team), and 2) two case vignettes to practice detecting delirium using family-administered delirium detection questionnaires (Family Confusion Assessment Method [FAM-CAM] and Sour Seven', 'intensive care unit family education intervention']","['delirium knowledge', 'Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ', 'delirium symptoms', 'knowledge regarding delirium risk factors (e.g., medication, mechanical ventilation), prevention/management (e.g., orientation, day/night routine), and symptoms of delirium']","[{'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0150577', 'cui_str': 'Education of family'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449719', 'cui_str': 'Part'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4524095', 'cui_str': 'Intensive care unit delirium'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0060056', 'cui_str': 'FAM protocol'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0150577', 'cui_str': 'Education of family'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4524095', 'cui_str': 'Intensive care unit delirium'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]",,0.0437768,"More family members correctly detected delirium symptoms in case vignettes using the Sour Seven (92%) compared with the FAM-CAM (78%).
","[{'ForeName': 'Karla D', 'Initials': 'KD', 'LastName': 'Krewulak', 'Affiliation': 'Department of Critical Care Medicine, Alberta Health Services& University of Calgary, Ground Floor, McCaig Tower, 3134 Hospital Drive NW, Calgary, AB, T2N 5A1, Canada.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Bull', 'Affiliation': 'College of Nursing, Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wesley Ely', 'Affiliation': ""Tennessee Valley Veteran's Affairs Geriatric Research Education Clinical Center (VA GRECC), Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Davidson', 'Affiliation': 'Department of Education, Development and Research, University of California, San Diego Health, San Diego, CA, USA.'}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Stelfox', 'Affiliation': 'Department of Critical Care Medicine, Alberta Health Services& University of Calgary, Ground Floor, McCaig Tower, 3134 Hospital Drive NW, Calgary, AB, T2N 5A1, Canada.'}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Fiest', 'Affiliation': 'Department of Critical Care Medicine, Alberta Health Services& University of Calgary, Ground Floor, McCaig Tower, 3134 Hospital Drive NW, Calgary, AB, T2N 5A1, Canada. kmfiest@ucalgary.ca.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01810-5']
2335,32959223,"Comparison of the Effect of Ceratonia siliqua L. (Carob) Syrup and Vitamin E on Sperm Parameters, Oxidative Stress Index, and Sex Hormones in Infertile Men: a Randomized Controlled Trial.","Herbal products with an antioxidant capacity can boost male reproductive functions. The empiric use of Ceratonia siliqua (carob) for its antioxidant properties is common among infertile men in Iran and Turkey. The objective of this study is to investigate the effects of C. siliqua (carob) on semen parameters, oxidative stress markers, and pregnancy rate in a parallel randomized, controlled study. A total of 60 infertile men with oligozoospermia, asthenospermia, and teratospermia were recruited from April 2018 to March 2019. Participants were divided randomly into the following two groups: carob syrup twice a day or vitamin E 100 mg twice a day for 3 months. Semen analysis was performed and hormonal levels and stress oxidative markers were measured in each treatment arm after 3 months. The quality of semen parameters improved in the carob group compared with Vit E semen count (p = 0.04 Cohen's d = .51), morphology (p = 0.001 Cohen's d = .93) and motility parameters (p = 0.002 Cohen's d = .90) were significantly higher in the carob group. No significant difference can be detected in post-treatment hormonal parameters and oxidative markers between groups, except for total antioxidant capacity(TAC) which was higher after post-treatment in carob group. A significantly higher pregnancy rate was found among the carob group. The administration of carob may be an effective agent for the improvement of semen parameters, probably related both to its involvement in the changing of testosterone level and to its antioxidant properties. Nevertheless, additional studies to evaluate the optimal dose and duration of treatment are needed. The trial has been registered in the Iranian Registry of Clinical Trials (Registration number: IRCT20171209037794N1.",2020,"No significant difference can be detected in post-treatment hormonal parameters and oxidative markers between groups, except for total antioxidant capacity(TAC) which was higher after post-treatment in carob group.","['Infertile Men', 'infertile men in Iran and Turkey', '60 infertile men with oligozoospermia, asthenospermia, and teratospermia were recruited from April 2018 to March 2019']","['Ceratonia siliqua L. (Carob) Syrup and Vitamin E', 'carob syrup twice a day or vitamin', 'Ceratonia siliqua (carob', 'C. siliqua (carob']","['motility parameters', 'Sperm Parameters, Oxidative Stress Index, and Sex Hormones', 'post-treatment hormonal parameters and oxidative markers', 'quality of semen parameters', 'total antioxidant capacity(TAC', 'semen parameters, oxidative stress markers, and pregnancy rate', 'hormonal levels and stress oxidative markers', 'pregnancy rate']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0028960', 'cui_str': 'Oligospermia'}, {'cui': 'C0403823', 'cui_str': 'Asthenospermia'}, {'cui': 'C0403824', 'cui_str': 'Teratozoospermia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0349918', 'cui_str': 'ceratonia'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0065146', 'cui_str': 'Carob'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}]","[{'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.104704,"No significant difference can be detected in post-treatment hormonal parameters and oxidative markers between groups, except for total antioxidant capacity(TAC) which was higher after post-treatment in carob group.","[{'ForeName': 'Mir Mohammad Reza', 'Initials': 'MMR', 'LastName': 'Aghajani', 'Affiliation': 'Infertility and Reproductive Health Research Center. Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Soleiman', 'Initials': 'S', 'LastName': 'Mahjoub', 'Affiliation': 'Infertility and Reproductive Health Research Center. Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Faraz', 'Initials': 'F', 'LastName': 'Mojab', 'Affiliation': 'Pharmaceutical Sciences Research Center and School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Namdari', 'Affiliation': 'Community Oral Health Department, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Neda Mahdinezhad', 'Initials': 'NM', 'LastName': 'Gorji', 'Affiliation': 'Infertility and Reproductive Health Research Center. Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dashtaki', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Parvaneh', 'Initials': 'P', 'LastName': 'Mirabi', 'Affiliation': 'Infertility and Reproductive Health Research Center. Health Research Institute, Babol University of Medical Sciences, Babol, Iran. parvaneh_mirabi@yahoo.com.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-020-00314-3']
2336,32959232,Prognostic value of preoperative glucose to lymphocyte ratio in patients with resected pancreatic cancer.,"BACKGROUND


Inflammatory factors and fasting blood glucose were verified to be associated with the prognosis of pancreatic ductal adenocarcinoma. The goal of this study is to confirm the prognostic role of preoperative blood glucose to lymphocyte ratio for patients with resected pancreatic ductal adenocarcinoma.
METHODS


A total of 259 pancreatic ductal adenocarcinoma patients were enrolled and randomly divided into training cohort and validation cohort. The training cohort was used to generate an optimal cutoff value and the validation cohort was used to further validate the model.
RESULTS


A total of 259 patients were incorporated in this study and randomly divided into the training cohort (n = 130, 1/2 of 259) and the validation cohort (129, 1/2 of 259). The optimal cutoff value of glucose to lymphocyte ratio was calculated to be 3.47 for overall survival. Cox regression analysis found that preoperative blood glucose to lymphocyte ratio was independent risk factor (p = 0.040) for overall survival. Prognostic values of glucose to lymphocyte ratio on overall survival were observed in younger male patients with pancreatic body and tail cancer, American Joint Committee on Cancer 8th N1 stage, without microvascular and peripancreatic fat invasion, and Carbohydrate antigen 19-9 higher than 200 U/ml. A prognostic prediction model of overall survival was designed and presented in nomogram.
CONCLUSION


Preoperative blood glucose to lymphocyte ratio is an independent biomarker to predict the overall survival for pancreatic ductal adenocarcinoma patients who underwent curative resection.",2020,Cox regression analysis found that preoperative blood glucose to lymphocyte ratio was independent risk factor (p = 0.040) for overall survival.,"['A total of 259 patients', '259 pancreatic ductal adenocarcinoma patients', 'patients with resected pancreatic cancer', 'patients with resected pancreatic ductal adenocarcinoma', 'pancreatic ductal adenocarcinoma patients who underwent curative resection', 'younger male patients with pancreatic body and tail cancer']",[],"['optimal cutoff value of glucose to lymphocyte ratio', 'preoperative blood glucose to lymphocyte ratio', 'overall survival']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0227582', 'cui_str': 'Structure of body of pancreas'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",[],"[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",259.0,0.0207054,Cox regression analysis found that preoperative blood glucose to lymphocyte ratio was independent risk factor (p = 0.040) for overall survival.,"[{'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Yaolin', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Dansong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Tiantao', 'Initials': 'T', 'LastName': 'Kuang', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Wenchuan', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Dayong', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital Fudan University, Ward 9, Building No.1, 180 Fenglin Road, Shanghai, China. lou.wenhui@zs-hospital.sh.cn.'}]",International journal of clinical oncology,['10.1007/s10147-020-01782-y']
2337,32959291,Psychedelische Trips - auf Placebo! : Schlaganfallrisiko.,,2020,,[],[],[],[],[],[],,0.181712,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hüll', 'Affiliation': 'Klinik für Geronto- und Neuropsychiatrie, Neubronnstraße 25, 79312, Emmendingen, Deutschland. m.huell@zfp-emmendingen.de.'}]",MMW Fortschritte der Medizin,['10.1007/s15006-020-4377-9']
2338,32959370,A Pilot Randomized Controlled Trial of a Nutrition and Dietary Intervention for Early Care and Education Providers.,"BACKGROUND


The aim of this study is to evaluate the feasibility and preliminary impact of the Create Healthy Futures program, a self-paced, 6-lesson, web-based intervention on promoting healthy eating for Early Care and Education (ECE) providers, using a group-randomized controlled trial design with 3 repeated measurements.
METHODS


Nine ECE facilities in Ohio were recruited and randomly assigned to intervention (N = 4) and comparison (N = 5). The 111 participants are mostly female (97.3%), college graduated (59.5%), and overweight or obese (75.2%). Nutrition-related psychosocial and environmental factors and individual behaviors were assessed at baseline, post-test, and 3-month follow-up. We used mixed model analyses to compare changes between time points, controlling for ethnicity, age, and center effect, and calculated effect size to assess the magnitude of change.
RESULTS


We observed significant between-group changes in improving nutrition knowledge (p = .003), increasing perceived support for staff wellness (p = .038), and reducing perceived barriers to eating fruits and vegetables (p = .004) and promoting nutrition in classrooms (p = .038), with small to medium effect sizes. The study demonstrated high feasibility with 94.1% enrollment rate, 87.5% intervention completion rate, and 83.8% retention rate.
CONCLUSIONS


This pilot study demonstrated high feasibility and acceptability of nutrition intervention programs using an online platform among ECE providers.",2020,"We observed significant between-group changes in improving nutrition knowledge (p = .003), increasing perceived support for staff wellness (p = .038), and reducing perceived barriers to eating fruits and vegetables (p = .004) and promoting nutrition in classrooms (p = .038), with small to medium effect sizes.","['healthy eating for Early Care and Education (ECE) providers', 'Nine ECE facilities in Ohio were recruited and randomly assigned to intervention', 'Early Care and Education Providers', '111 participants are mostly female (97.3%), college graduated (59.5%), and overweight or obese (75.2']","['Nutrition and Dietary Intervention', 'nutrition intervention programs']","['nutrition knowledge', 'perceived support for staff wellness', 'reducing perceived barriers to eating fruits and vegetables']","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",111.0,0.103981,"We observed significant between-group changes in improving nutrition knowledge (p = .003), increasing perceived support for staff wellness (p = .038), and reducing perceived barriers to eating fruits and vegetables (p = .004) and promoting nutrition in classrooms (p = .038), with small to medium effect sizes.","[{'ForeName': 'Ru-Jye', 'Initials': 'RJ', 'LastName': 'Chuang', 'Affiliation': 'Department of Epidemiology, Human Genetics and Environmental Sciences, Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, 1200 Pressler Street, RAS E615, Houston, TX, 77030, USA.'}, {'ForeName': 'Jill N', 'Initials': 'JN', 'LastName': 'Cox', 'Affiliation': 'Penn State Extension Better Kid Care, 2182 Sandy Drive, Suite 204, State College, PA, 16803, USA.'}, {'ForeName': 'Claudia C', 'Initials': 'CC', 'LastName': 'Mincemoyer', 'Affiliation': 'Penn State University, 2182 Sandy Drive, Suite 204, State College, PA, 16803, USA.'}, {'ForeName': 'Shreela V', 'Initials': 'SV', 'LastName': 'Sharma', 'Affiliation': '>Department of Epidemiology, Human Genetics and Environmental Sciences, Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, 1200 Pressler Street, RAS E643, Houston, TX, 77030, USA.'}]",The Journal of school health,['10.1111/josh.12951']
2339,32959431,Investigating the effects of a virtual reality-based stress management programme on inpatients with mental disorders: A pilot randomised controlled trial.,"This study aimed to examine the effects and feasibility of a virtual screen-based stress management programme (V-DESSERTS) on inpatients with mental disorders. A single-blinded, pilot randomised controlled trial was conducted in a tertiary hospital in Singapore. Convenience sampling was used and participants were randomised into either the intervention group or the waitlisted control group (WL). The intervention group received individual-based, twice-daily sessions of the programme. Each session comprised education and virtual screen-based relaxation practice. Data were collected through self-reported questionnaires and physiological measures. The intervention group showed a significant increase in perceived relaxation and knowledge in comparison with the WL group. However, inconclusive results were observed on subjective and objective stress. The findings in this study indicated that the V-DESSERTS programme is feasible to be implemented for patients with schizophrenia, depression and bipolar disorders.",2020,The intervention group showed a significant increase in perceived relaxation and knowledge in comparison with the WL group.,"['tertiary hospital in Singapore', 'inpatients with mental disorders', 'patients with schizophrenia, depression and bipolar disorders']","['waitlisted control group (WL', 'virtual screen-based stress management programme (V-DESSERTS', 'virtual reality-based stress management programme']","['subjective and objective stress', 'perceived relaxation and knowledge']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0453505', 'cui_str': 'Dessert'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0455419,The intervention group showed a significant increase in perceived relaxation and knowledge in comparison with the WL group.,"[{'ForeName': 'Hui Lin Emily', 'Initials': 'HLE', 'LastName': 'Tan', 'Affiliation': 'National University Hospital, Singapore.'}, {'ForeName': 'Cecilia Mui Lee', 'Initials': 'CML', 'LastName': 'Chng', 'Affiliation': 'National University Hospital, Singapore.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lau', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore.'}, {'ForeName': 'Piyanee', 'Initials': 'P', 'LastName': 'Klainin-Yobas', 'Affiliation': 'Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore.'}]",International journal of psychology : Journal international de psychologie,['10.1002/ijop.12713']
2340,32959458,Hypersensitivity to Calcitonin Gene-Related Peptide in Post-Traumatic Headache.,"OBJECTIVE


To demonstrate that calcitonin gene-related peptide (CGRP) induces headache exacerbation with migraine-like features in patients with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (TBI).
METHODS


A randomized, double-blind, placebo-controlled, 2-way crossover study. Analyses were intention-to-treat. Eligible patients were aged 18 to 65 years and had a history of persistent PTH after mild TBI for at least 12 months. Patients were randomized to receive intravenous infusion 1.5 μg/min of CGRP or placebo (isotonic saline) over 20 minutes on two separate experimental days. A 12-hour observational period was used to evaluate the following outcomes: 1) difference in incidence of headache exacerbation with migraine-like features, 2) difference in area under the curve for headache intensity scores.
RESULTS


Thirty patients (mean age, 37 years; 25 women [83%]) were randomized and completed the study. During the 12-hour observational period, 21 of 30 patients (70%) developed headache exacerbation with migraine-like features after CGRP, compared with six patients (20%) after placebo (P < 0.001). The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (P < 0.001).
INTERPRETATION


Patients with persistent PTH are hypersensitive to CGRP, which underscores its pathophysiological importance. Furthermore, CGRP-targeted therapies might provide a novel mechanism-based treatment option for patients with persistent PTH.
TRIAL REGISTRATION


Clinical.Trials.gov (NCT03791515). This article is protected by copyright. All rights reserved.",2020,"The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (P < 0.001).
","['Thirty patients (mean age, 37\u2009years; 25 women [83', 'Eligible patients were aged 18 to 65\u2009years and had a history of persistent PTH after mild TBI for at least 12\u2009months', 'patients with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (TBI', 'patients with persistent PTH']","['placebo', 'Calcitonin Gene-Related Peptide', 'calcitonin gene-related peptide (CGRP', 'intravenous infusion 1.5\u2009μg/min of CGRP or placebo (isotonic saline']","['headache intensity scores', 'headache exacerbation with migraine-like features, 2) difference in area under the curve for headache intensity scores', 'headache exacerbation with migraine-like features']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0032816', 'cui_str': 'Posttraumatic headache'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.678888,"The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (P < 0.001).
","[{'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Afrim', 'Initials': 'A', 'LastName': 'Iljazi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Haidar M', 'Initials': 'HM', 'LastName': 'Al-Khazali', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Casper E', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik W', 'Initials': 'HW', 'LastName': 'Schytz', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Annals of neurology,['10.1002/ana.25915']
2341,32959481,A Guided Internet-delivered intervention for adjustment disorders: A randomized controlled trial.,"Evidence of self-help interventions for Adjustment Disorder (AjD) is limited. This study aims at testing in a RCT the effectiveness of a disorder-specific, Internet-delivered CBT (ICBT) intervention for AjD. Participants were randomly allocated to either an ICBT with brief weekly telephone support (n=34) or a waiting list group (n=34). Beck's inventories for depression and anxiety were used as primary outcomes. The secondary outcomes were adjustment disorder symptoms, posttraumatic growth, positive and negative affect, and quality of life. In all, 76.5% of the participants completed the intervention. Compared to the control group, participants in the intervention condition showed significantly greater improvement in all outcomes (Cohen's d ranged from.54 to 1.21) except in anxiety symptoms measured by Beck's Anxiety Inventory (d=.27). Only ICBT group showed a significant improvement in posttraumatic growth, positive and negative affect, and quality of life. Number of cases that achieved clinically meaningful change in all outcome measures was also higher in the ICBT group. All therapeutic gains were maintained at 3, 6, and 12-month follow-ups. The current study provides evidence on the effectiveness of ICBT interventions to reduce the impact of AjD. Results suggest that brief self-help intervention with minimal therapist support is more effective than the mere passage of time in reducing the distress symptoms associated to the disorder and also can confer additional benefits.",2020,"Compared to the control group, participants in the intervention condition showed significantly greater improvement in all outcomes (Cohen's d ranged from.54 to 1.21) except in anxiety symptoms measured by Beck's Anxiety Inventory (d=.27).",['AjD. Participants'],"['ICBT with brief weekly telephone support (n=34) or a waiting list group', 'Guided Internet-delivered intervention', 'ICBT interventions', 'disorder-specific, Internet-delivered CBT (ICBT) intervention', 'ICBT']","['posttraumatic growth, positive and negative affect, and quality of life', 'anxiety symptoms', 'adjustment disorder symptoms, posttraumatic growth, positive and negative affect, and quality of life']","[{'cui': 'C0001546', 'cui_str': 'Adjustment disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]","[{'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0001546', 'cui_str': 'Adjustment disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0662501,"Compared to the control group, participants in the intervention condition showed significantly greater improvement in all outcomes (Cohen's d ranged from.54 to 1.21) except in anxiety symptoms measured by Beck's Anxiety Inventory (d=.27).","[{'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Rachyla', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mor', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castilla', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition (CIBEROBN, Madrid, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Quero', 'Affiliation': 'Universitat Jaume I, Castellón, Spain.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2518']
2342,32959502,Plasma D-dimer concentrations predicting stroke risk and rivaroxaban benefit in patients with heart failure and sinus rhythm: an analysis from the COMMANDER-HF trial.,"BACKGROUND


D-dimer is a marker of fibrin degradation that reflects intra-vascular coagulation. Therefore, plasma concentrations of D-dimer might predict thromboembolic risk and rivaroxaban treatment effect.
AIMS


To investigate the association between D-dimer levels and the risk of stroke and other thrombotic, bleeding and fatal events, and whether D-dimer concentrations could predict rivaroxaban 2.5mg/bd (vs. placebo) effect in patients enrolled in the COMMANDER-HF trial who were in sinus rhythm, had HFrEF and coronary artery disease.
METHODS


Survival models with treatment-by-plasma D-dimer interaction. Baseline measurement of D-dimer was available in 4,107 (82%) of 5,022 patients enrolled. Median (percentile 25-75  ) follow-up was 21 (12.9-32.8) months.
RESULTS


The median (percentile 25-75  ) plasma concentration of D-dimer was 360 (215-665)ng/mL. The D-dimer tertiles were: 1) ≤255; 2) 256-515; 3) >515ng/mL. Patients within the tertile-3 were older, and had lower BMI, blood pressure, hemoglobin, eGFR, and LVEF. Higher plasma D-dimer concentrations were independently associated with higher rates of death, stroke, and venous thromboembolism. For example, the all-cause death adjusted HR (95%CI) of tertile-3 vs. tertile-1 was 1.77 (1.48-2.11), p<0.001. The effect of rivaroxaban was similar in each tertile of D-dimer for all outcomes except stroke. Patients within the tertile-3 had the greatest absolute and relative stroke reduction (HR [95%CI] tertile-1=1.16 [0.49-2.74], tertile-2=1.45 [0.77-2.73], and tertile-3=0.36 [0.18-0.70]; interaction p  =0.008). The number-needed-to-treat to prevent one stroke in tertile-3 was 36.
CONCLUSION


In COMMANDER-HF, rivaroxaban reduced the risk of stroke but the benefit may be confined to patients with D-dimer concentrations above 515ng/mL. Prospective trials are warranted to confirm these findings.",2020,"515ng/mL. Patients within the tertile-3 were older, and had lower BMI, blood pressure, hemoglobin, eGFR, and LVEF.","['Survival models with treatment-by-plasma D-dimer interaction', 'patients with heart failure and sinus rhythm', 'patients enrolled in the COMMANDER-HF trial who were in sinus rhythm, had HFrEF and coronary artery disease', '5,022 patients enrolled']","['rivaroxaban', 'placebo']","['relative stroke reduction', 'Higher plasma D-dimer concentrations', 'lower BMI, blood pressure, hemoglobin, eGFR, and LVEF', 'death, stroke, and venous thromboembolism']","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C4521843', 'cui_str': 'US Military Commissioned Officer O5'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",5022.0,0.278366,"515ng/mL. Patients within the tertile-3 were older, and had lower BMI, blood pressure, hemoglobin, eGFR, and LVEF.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Université de Lorraine, Nancy, France.""}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore, Duke-National University of Singapore, Singapore.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Berlin-Brandenburg Center for Regenerative Therapies, Berlin, Germany.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Byra', 'Affiliation': 'Janssen Research and Development, Raritan, New, Jersey.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'La Police', 'Affiliation': 'Janssen Research and Development, Raritan, New, Jersey.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics and Clinical Trials, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Greenberg', 'Affiliation': 'Cardiology Division, Department of Medicine, University of California, San Diego, La Jolla.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Université de Lorraine, Nancy, France.""}]",European journal of heart failure,['10.1002/ejhf.2003']
2343,32959548,[Application of three-in-one intelligent screening in outpatient department of children's hospital during the COVID-19 epidemic].,"OBJECTIVE


: To evaluate the application of three-in-one intelligent screening in outpatient pre-inspection in Children's Hospital.
METHODS


We randomly enrolled 100 children pre-screened by traditional in the outpatient department of Children's Hospital Zhejiang University School of Medicine from February 6th to 16th, 2020, and another 100 children by the intelligent three-in-one mode from February 17th to 27th, 2020. The traditional triage was conducted by nurses based on face-to-face, one-by-one interview of the epidemiological history and consultation department, and the temperature was measured before manual triage. The intelligent three-in-one model of pre-inspection and triage combined online rapid pre-inspection and triage, on-site manual confirmation, as well as synchronized online health education system. For on-line registered patients, the system automatically sent the COVID-19 epidemiological pre-screening triage questionnaire one hour before the appointment, requiring parents to complete and submit online before arriving at the hospital. The on-site registered patients were controlled at 100 m outside of the hospital entrance. The nurses guided the parents to scan the QR code and fill in the COVID-19 epidemiological pre-examination triage questionnaire. At the entrance of the hospital, the nurse checked the guide sheet and took the temperature again. The children with red guidance sheet for isolation clinic were checked again and confirmed by pre-examination nurses, and accompanied to the isolation clinic by a special channel. The children with yellow guidance sheet were guided to fever clinic; parents with green guidance sheet took their children to the designated area by themselves, and then went to the corresponding consultation area after on-site manual pre inspection and registration. The whole process of health education was associated with outpatient notes, and the system automatically posted the corresponding outpatient instructions and education courses. Parents would read the courses on their mobile phones and counsel online. The time of pre-examination and the coincidence rate of triage were compared between the two groups.
RESULTS


The three-in-one intelligent pre-inspection mode took an average of (25.6±8.0) seconds for each child, which was significantly shorter than the traditional pre-inspection mode (74.8±36.4 seconds) ( t =13.182,  P <0.01). The triage coincidence rate of the intelligent pre-inspection model was 98%, which was similar to that of traditional model (97%,  χ 2 =0.251,  P >0.05).
CONCLUSIONS


The three-in-one intelligent pre-inspection model can effectively shorten the patient pre-check time, with similar triage coincidence rate to traditional model.",2020,"The triage coincidence rate of the intelligent pre-inspection model was 98%, which was similar to that of traditional model (97%,  χ 2 =0.251,  P >0.05).
","[""100 children pre-screened by traditional in the outpatient department of Children's Hospital Zhejiang University School of Medicine from February 6th to 16th, 2020, and another 100 children by the intelligent three-in-one mode from February 17th to 27th, 2020"", ""outpatient department of children's hospital during the COVID-19 epidemic""]",[],"['triage coincidence rate', 'time of pre-examination and the coincidence rate of triage']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}]",[],"[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",100.0,0.0214723,"The triage coincidence rate of the intelligent pre-inspection model was 98%, which was similar to that of traditional model (97%,  χ 2 =0.251,  P >0.05).
","[{'ForeName': 'Meiping', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tong', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}, {'ForeName': 'Cangcang', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': 'Zhejiang GooCan Information Technology Co., Ltd, Hangzhou 310052, China.'}, {'ForeName': 'Tianlin', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}, {'ForeName': 'Guohong', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}, {'ForeName': 'Hongzhen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou 310052, China.""}]",Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences,['10.3785/j.issn.1008-9292.2020.08.09']
2344,32959557,[Influence on orbicularis oculi muscle in the patients with facial neuritis treated with the penetra-ting needling at Cuanzhu (BL2) and Yuyao (EX-HN4) combined with the perpendicular needling at Shenmai (BL62)].,"OBJECTIVE


To explore the therapeutic effect on incomplete eyelid in the patients with facial neuritis treated with the penetrating needling at Cuanzhu (BL2) and Yuyao (EX-HN4) combined with the perpendicular needling at Shenmai (BL62).
METHODS


A total of 64 patients with facial neuritis, in compliance with the inclusion criteria, were randomized into a treatment group and a control group, with 32 cases in each. In the treatment group, the penetrating needling was applied to BL2 and EX-HN4 on the affected side, combined with the perpendicular needling at bilateral BL62. Besides, on the affected side, the penetrating needling was applied from Yangbai (GB14) toward four directions, named Shangxing (GV23), Touwei (ST8), Cuanzu (BL2) and Sizukong (TE23), the mutual penetrating needling was adopted between Dicang (ST4) and Jiache (ST6). Between Yingxiang (LI20) and Xiaguan (ST7), a row-arranged needling technique was applied. All of the needles were retained for 10 to 30 min in each treatment. The treatment was given once daily and the treatment for 10 days was as 1 course. A total of 2 courses of treatment were required. In the control group, prednisone acetate （30 mg/d）, was administered consecutively for 5 days. Afterward, the dose was reduced to be 10 mg/d and the medication stopped after taking consecutively for 1 week. Muscular injection with vitamin B 12  （0.5 mg） and B 1  （0.1 mg） was given, once daily. 10 days later, vitamin B1 was taken for oral administration, 10 mg each time, three times a day, for 10 days totally. Before and after the treatment, the clinical effect was compared between the two groups in terms of the analysis on the Hourse-Brackman (H-B) grade of facial nerve function, the distance between the upper and the lower eyelids, muscle strength, degree of eyelid closure and electromyogram (EMG).
RESULTS


The total effective rate of treatment group was 96.9 % (31/32), better than 84.4%（27/32） in the control group ( P <0.05). After treatment, in the treatment group, the distance between the upper and lower eyelids, the muscle strength, the degree of eyelid closure, the wave amplitude of motor nerve conduction and the latent period, as well as the blink reflex were all improved as compared with those before the treatment ( P <0.01,  P <0.05). In the control group, the distance between the upper and lower eyelids, the muscle strength, the degree of eyelid closure, the latent period of motor nerve conduction and the blink reflex were all improved as compared with those before the treatment ( P <0.01,  P <0.05). After the treatment, the results of the distance between the upper and lower eyelids, the muscle strength, the degree of eyelid closure, the wave amplitude of motor nerve conduction and the latent period, as well as the blink reflex in the treatment group were all better than those in the control group ( P <0.05， P <0.01).
CONCLUSION


The treatment with the penetrating needling at Cuanzhu (BL2) and Yuyao (EX-HN4) combined with the perpendicular needling at Shenmai (BL62) greatly promotes the recovery of orbicularis oculi muscle in the patients with facial neuritis, reduces the complications and presents the satisfactory clinical effect.",2020,"The total effective rate of treatment group was 96.9 % (31/32), better than 84.4%（27/32） in the control group ( P <0.05).","['patients with facial neuritis', 'patients with facial neuritis treated with the', '64 patients with facial neuritis, in compliance with the inclusion criteria']","['penetra-ting needling at Cuanzhu (BL2) and Yuyao (EX-HN4) combined with the perpendicular needling at Shenmai (BL62', 'Yingxiang (LI20) and Xiaguan (ST7', 'prednisone acetate （', 'named Shangxing (GV23), Touwei (ST8), Cuanzu (BL2) and Sizukong (TE23), the mutual penetrating needling was adopted between Dicang (ST4) and Jiache (ST6', 'Muscular injection with vitamin B 12  （0.5 mg） and B 1  （0.1 mg）', 'vitamin B1', 'penetrating needling at Cuanzhu (BL2) and Yuyao (EX-HN4) combined with the perpendicular needling at Shenmai (BL62']","['muscle strength, the degree of eyelid closure, the wave amplitude of motor nerve conduction and the latent period, as well as the blink reflex', 'Hourse-Brackman (H-B) grade of facial nerve function, the distance between the upper and the lower eyelids, muscle strength, degree of eyelid closure and electromyogram (EMG', 'total effective rate', 'distance between the upper and lower eyelids, the muscle strength, the degree of eyelid closure, the latent period of motor nerve conduction and the blink reflex', 'distance between the upper and lower eyelids, the muscle strength, the degree of eyelid closure, the wave amplitude of motor nerve conduction and the latent period, as well as the blink reflex']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751131', 'cui_str': 'Facial Neuritis'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0723760', 'cui_str': 'Ting'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1295725', 'cui_str': 'Perpendicular axis'}, {'cui': 'C0603925', 'cui_str': 'fructus schizandrae, radix ginseng, radix ophiopogonis drug combination'}, {'cui': 'C0450656', 'cui_str': 'BL62'}, {'cui': 'C0450504', 'cui_str': 'ST7'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0450503', 'cui_str': 'ST6'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1293738', 'cui_str': 'Eyelid closure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0027788', 'cui_str': 'Nerve conduction'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0596003', 'cui_str': 'Blink reflex'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0234290', 'cui_str': 'Seventh cranial nerve function'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",64.0,0.0152609,"The total effective rate of treatment group was 96.9 % (31/32), better than 84.4%（27/32） in the control group ( P <0.05).","[{'ForeName': 'Li-Wei', 'Initials': 'LW', 'LastName': 'Xu', 'Affiliation': 'Department of Chinese Medicine, Affiliated Hospital of Chengde Medical College, Chengde 067000, Hebei Province, China.'}, {'ForeName': 'Xing-Miao', 'Initials': 'XM', 'LastName': 'Quan', 'Affiliation': 'Department of Chinese Medicine, Affiliated Hospital of Chengde Medical College, Chengde 067000, Hebei Province, China.'}, {'ForeName': 'Chun-Xia', 'Initials': 'CX', 'LastName': 'Song', 'Affiliation': 'Department of Chinese Medicine, Affiliated Hospital of Chengde Medical College, Chengde 067000, Hebei Province, China.'}, {'ForeName': 'Yu-Lan', 'Initials': 'YL', 'LastName': 'Liu', 'Affiliation': 'Department of Chinese Medicine, Affiliated Hospital of Chengde Medical College, Chengde 067000, Hebei Province, China.'}, {'ForeName': 'Hong-Yan', 'Initials': 'HY', 'LastName': 'Xu', 'Affiliation': 'Department of Chinese Medicine, Affiliated Hospital of Chengde Medical College, Chengde 067000, Hebei Province, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190894']
2345,32959567,[Percutaneous pedicle screw fixation combined with vertebroplasty for the treatment of Genant Ⅲ degree osteoporotic vertebral compression fractures].,"OBJECTIVE


To investigate the clinical effect of percutaneous pedicle screw fixation(PPSF) combined with percutaneous vertebroplasty (PVP) in the treatment of Genant Ⅲ degree osteoporotic vertebral compression fractures (OVCFs).
METHODS


The hospitalized 83 patients with Genant Ⅲ degree OVCFs treated by PPSF combined with PVP from June 2015 to June 2017 were retrospectively analyzed, and 83 patients treated by PVP alone from January 2013 to June 2016 were randomly selected as the control group. There were 19 males and 64 females with an average age of (73.6±11.0) years in combined group with treatment of PPSF and PVP. There were 15 malesand 68 females with an average age of (75.5±10.6) years in control group. The anterior edge height of the vertebral body and Cobb angle before operation, 1 day, and 6, 12, 24 months after operation were compared between two groups. Visual analogue scale(VAS) and Oswestry Disability Index (ODI) were used to assess the pain level and daily lumbar dysfunction for patients, respectively. The complications were observed.
RESULTS


The follow-up time of all patients was more than 2 years. The combined group and control group were (24.3±10.2) months and (27.5±14.8) months, respectively. There were no statistically significant differences in the anterior edge height of the vertebral body and Cobb angle at 1 day after surgery between two groups ( P >0.05), and there were statistically significant differences at 6, 12, 24 months after surgery between two groups ( P <0.01). The difference in ODI and VAS scores at 6 and 12 months after operation between two groups was statistically significant ( P <0.05). Postoperative complications incontrol group were higher than those in the combined group.
CONCLUSION


PPSF combined with PVP for the treatment of Genant Ⅲ degree OVCFs is superior to PVP alone in terms of vertebral height loss, patient satisfaction, and complications.",2020,The difference in ODI and VAS scores at 6 and 12 months after operation between two groups was statistically significant ( P <0.05).,"['Genant Ⅲ degree osteoporotic vertebral compression fractures', '19 males and 64 females with an average age of (73.6±11.0) years in combined group with treatment of PPSF and PVP', 'Genant Ⅲ degree osteoporotic vertebral compression fractures (OVCFs', 'hospitalized 83 patients with Genant Ⅲ degree OVCFs treated by PPSF combined with PVP from June 2015 to June 2017 were retrospectively analyzed, and 83 patients treated by PVP alone from January 2013 to June 2016 were randomly selected as the control group', '15 malesand 68 females with an average age of (75.5±10.6) years in control group']","['Percutaneous pedicle screw fixation combined with vertebroplasty', 'percutaneous pedicle screw fixation(PPSF) combined with percutaneous vertebroplasty (PVP']","['Visual analogue scale(VAS) and Oswestry Disability Index (ODI', 'anterior edge height of the vertebral body and Cobb angle', 'pain level and daily lumbar dysfunction', 'ODI and VAS scores', 'vertebral height loss, patient satisfaction, and complications']","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0424641', 'cui_str': 'Decrease in height'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",83.0,0.0127262,The difference in ODI and VAS scores at 6 and 12 months after operation between two groups was statistically significant ( P <0.05).,"[{'ForeName': 'Zhi-Kun', 'Initials': 'ZK', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200336, China.'}, {'ForeName': 'You-Jia', 'Initials': 'YJ', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200336, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200336, China.'}, {'ForeName': 'Xiao-Dong', 'Initials': 'XD', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthopaedics, Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200336, China.'}, {'ForeName': 'Guang-Fei', 'Initials': 'GF', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200336, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopaedics, Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200336, China.'}, {'ForeName': 'Yi-Fan', 'Initials': 'YF', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedics, Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200336, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200336, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.09.004']
2346,32959568,[Clinical application of zoledronic acid combined with vitamin K2 in percutaneous vertebroplasty for multi-segment osteoporotic vertebral compression fractures].,"OBJECTIVE


To explore the clinical effect of zoledronic acid combined with vitamin K2 regimen in percutaneous vertebroplasty for multi-segment osteoporotic vertebral compression fractures(OVCFs).
METHODS


This study was a retrospective control study. A total of 364 patients with OVCFs who were admitted to our spinal surgery department from January 2014 to January 2017 were selected as the study subjects. According to whether zoledronic acid combined with vitamin K2 was used to treat osteoporosis after surgery, the patients were divided into control group and experimental group. Among them, 257 patients in the control group were treated with calcium carbonate and vitamin D regimen, while 107 patients in the experimental group were treated with zoledronic acid combined with vitamin K2 regimen on the basis of the control group. Visual analogue scale (VAS) score and Oswestry Disability Index (ODI) were used to evaluate the clinical effect. Pre- and post-operative bone mineral density of lumbar spine and proximal femur, vertebral height ratio of responsible vertebral body and Cobb angle of vertebral body were observed by image data. Serological indicators related to bone metabolism were detected by laboratory. The complications such as fever, dizziness, osteoarthritis, muscular and soft tissue pain and adjacent vertebral re-fracture were compared between two groups.
RESULTS


There was no significant difference in general data between the two groups ( P <0.05). There was no significant difference in VAS score between experimental group and control group before and 24 hours after operation ( P >0.05);VAS score in the experimental group was significantly lower than that in the control group 1 month, 3 months and 1 year after operation( P <0.05). There was no significant difference in ODI between two groups before operation( P >0.05), and at the 24 hours, 3 months, 1 year after operation, the experimental group was significantly lower than the control group ( P <0.05). There was no significant difference in the vertebral height ratio of the responsible vertebral body and the Cobb angle before operation between two groups ( P >0.05). The vertebral height ratio of the responsible vertebral body in experimental group was significantly higher than that in control group and Cobb angle in experimental group was significantly lower than that in control group at 3 months and 1 year after operation ( P <0.05). There was no significant difference in preoperative bone mineral density of lumbar spine and proximal femur between two groups ( P >0.05), but at 3 months and 1 year after operation, the bone mineral density of lumbar spine and proximal femur in experimental group was significantly lower than that in control group ( P < 0.05). There was no significant difference in preoperative bone metabolic markers such as total type I collagen amino-terminal elongation peptide, β-collagen degradation products and 25-hydroxyvitamin D between two groups ( P >0.05). At 1 year after operation the total type I collagen amino-terminal elongation peptide and β-collagen degradation products in experimental group was significantly lower than that in the control group ( P <0.05), but the 25-hydroxyvitamin D operation in experimental group was significantly higher than that in control group( P <0.05). The incidence of postoperative complications such as fever, dizziness, osteoarthritis, muscle and soft tissue pain and adjacent vertebral re-fracture in experimental group was significantly lower than that in control group ( P <0.05).
CONCLUSION


Zoledronic acid injection combined with vitamin K2 regimen can be used for anti-osteoporosis treatment of OVCFs vertebroplasty. It has a definite curative effect and a high safety factor. It is worth popularizing.",2020,"There was no significant difference in preoperative bone mineral density of lumbar spine and proximal femur between two groups ( P >0.05), but at 3 months and 1 year after operation, the bone mineral density of lumbar spine and proximal femur in experimental group was significantly lower than that in control group ( P < 0.05).","['percutaneous vertebroplasty for multi-segment osteoporotic vertebral compression fractures(OVCFs', 'multi-segment osteoporotic vertebral compression fractures', '257 patients in the control group', '364 patients with OVCFs who were admitted to our spinal surgery department from January 2014 to January 2017 were selected as the study subjects']","['Zoledronic acid injection combined with vitamin K2 regimen', 'zoledronic acid combined with vitamin K2', 'zoledronic acid combined with vitamin K2 regimen', 'calcium carbonate and vitamin D regimen']","['bone mineral density of lumbar spine and proximal femur', 'ODI', 'preoperative bone metabolic markers such as total type I collagen amino-terminal elongation peptide, β-collagen degradation products and 25-hydroxyvitamin D', 'incidence of postoperative complications such as fever, dizziness, osteoarthritis, muscle and soft tissue pain and adjacent vertebral re-fracture', '25-hydroxyvitamin D operation', 'vertebral height ratio of responsible vertebral body and Cobb angle of vertebral body', 'bone metabolism', 'VAS score', 'general data', 'preoperative bone mineral density of lumbar spine and proximal femur', 'Visual analogue scale (VAS) score and Oswestry Disability Index (ODI', 'complications such as fever, dizziness, osteoarthritis, muscular and soft tissue pain and adjacent vertebral re-fracture', 'total type I collagen amino-terminal elongation peptide and β-collagen degradation products', 'vertebral height ratio of the responsible vertebral body', 'vertebral height ratio of the responsible vertebral body and the Cobb angle before operation']","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C4301710', 'cui_str': 'zoledronic acid Injection'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0719097', 'cui_str': 'Calcium Carbonate / Vitamin D'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}]",364.0,0.0110458,"There was no significant difference in preoperative bone mineral density of lumbar spine and proximal femur between two groups ( P >0.05), but at 3 months and 1 year after operation, the bone mineral density of lumbar spine and proximal femur in experimental group was significantly lower than that in control group ( P < 0.05).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""The Third Department of Orthopaedics, the Second People's Hospital of Nanyang, Nanyang 473000, Henan, China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""The Third Department of Orthopaedics, the Second People's Hospital of Nanyang, Nanyang 473000, Henan, China.""}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.09.006']
2347,32959579,[Anatomical study on the feasibility of a new self-guided pedicle tap].,"OBJECTIVE


To evaluate the accuracy and safety of pedicle screw placement using a new self-guided pedicle tap.
METHODS


According to the anatomical characteristics of the pedicle, a new self-guided pedicle tap was developed. Six adult spinal specimens including 4 males and 2 females were selected and tapped thread on the right and left sides of each pair of pedicles from the same segment T 1  to L 5  with traditional taps (control group) and new self-guided pedicle taps (experimental group), respectively. And the pedicle screws were placed. The screwing time was recorded and compared between two groups. CT scanning was completed to observe the accuracy and safety of the screw placement according to the Heary classification of imaging results.
RESULTS


The screwing time of thoracic and lumbar vertebrae in the experimental group were (5.87±1.25) min and(5.45±1.67) min, respectively. While those in the control group were (6.12±1.69) min and (6.22±2.13) min, respectively. Then there was no significant difference in screwing time of thoracic and lumbar vertebrae between two groups ( P >0.05). The Heary grade of the pedicle screw showed that Heary gradeⅠand Heary gradeⅠ+Ⅱwere respectively 86 (84.31%) and 96 (94.12%) in the experimental group, 72 (71.29%) and 84 (83.17%) in control group, and the difference between two groups was statistically significant ( P <0.05).
CONCLUSION


The new self-guided pedicle tap can accurately and safely insert the thoracolumbar pedicle screw, with low cost, easy operation, and good clinical application value.",2020,Then there was no significant difference in screwing time of thoracic and lumbar vertebrae between two groups ( P >0.05).,['Six adult spinal specimens including 4 males and 2 females'],"['pedicle screw placement', 'CT scanning', 'L 5  with traditional taps (control group) and new self-guided pedicle taps', 'new self-guided pedicle tap']","['Heary grade of the pedicle screw', 'screwing time', 'accuracy and safety', 'screwing time of thoracic and lumbar vertebrae']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0456605', 'cui_str': 'Pedicle'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",,0.0185898,Then there was no significant difference in screwing time of thoracic and lumbar vertebrae between two groups ( P >0.05).,"[{'ForeName': 'Yong-Tao', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'Xiao-Ji', 'Initials': 'XJ', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'Jia-Cheng', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'Xiao-Jian', 'Initials': 'XJ', 'LastName': 'Cao', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.09.017']
2348,32959582,[Effect of moxibustion on inflammatory factors and oxidative stress factors in patients with knee osteoarthritis: a randomized controlled trial].,"OBJECTIVE


To compare the clinical efficacy between moxibustion and acupuncture for knee osteoarthritis (KOA), and to observe the effect on serum tumor necrosis factor-α(TNF-α), interleukin-1β(IL-1β), superoxide dismutase (SOD) and malondialdehyde (MDA).
METHODS


A total of 60 patients with KOA were randomized into a moxibustion group (30 cases, 2 cases dropped off) and an acupuncture group (30 cases, 2 cases dropped off). In the aucpuncture group, acupuncture was applied at Neixiyan (EX-LE 4), Dubi (ST 35), Heding (EX-LE 2), Xuehai (SP 10), Liangqiu (ST 34), Zusanli (ST 36) and  ashi  point on the affected side for 30 min.In the moxibustion group, moxibustion was adopted at knee for 60 min. The treatment was given once every two days for 4 weeks, totally 14 times. Before and after treatment, the western ontario and McMaster universities osteoarthritis index (WOMAC) score was compared, and the therapeutic effect was evaluated in the two groups. The contents of serum TNF-αand IL-1β, the activity of serum SOD and the serum level of MDA were detected in the two groups.
RESULTS


Compared before treatment, the WOMAC scores and the contents of serum TNF-α, IL-1β and MDA after treatment were reduced ( P <0.05), the activity of serum SOD was increased ( P <0.05) in the two groups. In the moxibustion group, the WOMAC score and the contents of serum TNF-α, IL-1β and MDA after treatment were lower than the acupuncture group ( P <0.05), the activity of serum SOD was higher than the acupuncture group ( P <0.05). The total effective rate was 89.3% (25/28) in the moxibustion group, which was superior to 42.9% (12/28) in the acupuncture group ( P <0.05).
CONCLUSION


Moxibustion and acupuncture can relieve KOA symptoms, and the therapeutic effect of moxibustion is superior to acupuncture. The mechanism may be related to the reduction of serum inflammatory factor and oxidative stress factor.",2020,"Compared before treatment, the WOMAC scores and the contents of serum TNF-α, IL-1β and MDA after treatment were reduced ( P <0.05), the activity of serum SOD was increased ( P <0.05) in the two groups.","['knee osteoarthritis (KOA', '60 patients with KOA', 'patients with knee osteoarthritis']","['moxibustion and acupuncture', 'Moxibustion and acupuncture', 'acupuncture', 'TNF-αand', 'moxibustion']","['WOMAC scores and the contents of serum TNF-α, IL-1β and MDA', 'KOA symptoms', 'therapeutic effect', 'IL-1β, the activity of serum SOD and the serum level of MDA', 'western ontario and McMaster universities osteoarthritis index (WOMAC) score', 'total effective rate', 'serum tumor necrosis factor-α(TNF-α), interleukin-1β(IL-1β), superoxide dismutase (SOD) and malondialdehyde (MDA', 'contents of serum', 'activity of serum SOD', 'WOMAC score and the contents of serum TNF-α, IL-1β and MDA', 'inflammatory factors and oxidative stress factors']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",60.0,0.0298896,"Compared before treatment, the WOMAC scores and the contents of serum TNF-α, IL-1β and MDA after treatment were reduced ( P <0.05), the activity of serum SOD was increased ( P <0.05) in the two groups.","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'College of Basic Medicine, Hebei Univerisity of TCM, Shijiazhuang 050091, China.'}, {'ForeName': 'Rui-Qing', 'Initials': 'RQ', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei Univerisity of TCM, Shijiazhuang 050091, China.'}, {'ForeName': 'Jing-Xuan', 'Initials': 'JX', 'LastName': 'Liu', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei Univerisity of TCM, Shijiazhuang 050091, China.'}, {'ForeName': 'Zi-di', 'Initials': 'ZD', 'LastName': 'Zhang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei Univerisity of TCM, Shijiazhuang 050091, China.'}, {'ForeName': 'Ye-Juan', 'Initials': 'YJ', 'LastName': 'Jia', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei Univerisity of TCM, Shijiazhuang 050091, China.'}, {'ForeName': 'Jiu-Heng', 'Initials': 'JH', 'LastName': 'Lv', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei Univerisity of TCM, Shijiazhuang 050091, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'College of Basic Medicine, Hebei Univerisity of TCM, Shijiazhuang 050091, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei Univerisity of TCM, Shijiazhuang 050091, China.'}, {'ForeName': 'Chun-Sheng', 'Initials': 'CS', 'LastName': 'Jia', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hebei Univerisity of TCM, Shijiazhuang 050091, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200310-k0011']
2349,32959583,[Clinical observation of dynamic scalp acupuncture combined with task-oriented mirror therapy for upper limbs function impairment in patients with hemiplegia after ischemic stroke].,"OBJECTIVE


To explore the effect of dynamic scalp acupuncture combined with task-oriented mirror therapy (TOMT) for upper limb motor function and activity ability of daily living in patients with hemiplegia after ischemic stroke.
METHODS


Seventy-eight patients with hemiplegia after ischemic stroke were randomly divided into a dynamic scalp acupuncture group, a TOMT group, and a scalp acupuncture group, 26 cases in each group (1 case dropped off in the TOMT group and the scalp acupuncture group respectively). All three groups received routine rehabilitation training and medication treatment. The TOMT group was treated with TOMT for 40 min a day, 5 days a week for 8 weeks. The scalp acupuncture group was treated with TOMT after the scalp acupuncture, and the dynamic scalp acupuncture group was treated with TOMT during the scalp acupuncture treatment. The scalp acupuncture treatment was applied at ipsilateral up 1/5 and mid 2/5 of  Dingnie Qianxiexian  and  Dingnie Houxiexian , and the needles were retained for 40 min. The scalp acupuncture treatment was given once a day, 5 days a week for 8 weeks. Before treatment and after 4 weeks and 8 weeks of treatment, the functions of upper limb and hand were evaluated by simplified Fugl-Meyer assessment (FMA) scale upper limb part and functional test for the hemiplegic upper extremity-Hong Kong version (FTHUE-HK) grade, the muscle tension of the upper extremity flexor elbow muscle group was assessed by modified Ashworth scale (MAS) and the activity ability of daily living was assessed by modified Barthel index (MBI).
RESULTS


After 4 weeks and 8 weeks of treatment, the FMA scores, FTHUE-HK grades and MBI scores in the three groups were better than those before treatment ( P <0.01,  P <0.05), and MAS scores after 4 weeks of treatment in the three groups were better than those before treatment ( P <0.05). After 4 weeks and 8 weeks of treatment, the FMA scores, FTHUE-HK grades and MBI scores in the dynamic scalp acupuncture group were better than those in the TOMT group and the scalp acupuncture group ( P <0.05), and these items in the scalp acupuncture group were better than those in the TOMT group ( P <0.05).
CONCLUSION


The dynamic scalp acupuncture combined with TOMT treatment can effectively improve the upper limb function and the activities ability of daily living in patients with hemiplegia after ischemic stroke, which is better than TOMT after scalp acupuncture and simple TOMT treatment.",2020,"After 4 weeks and 8 weeks of treatment, the FMA scores, FTHUE-HK grades and MBI scores in the dynamic scalp acupuncture group were better than those in the TOMT group and the scalp acupuncture group ( P <0.05), and these items in the scalp acupuncture group were better than those in the TOMT group ( P <0.05).
","['patients with hemiplegia after ischemic stroke', 'Seventy-eight patients with hemiplegia after ischemic stroke']","['dynamic scalp acupuncture', 'routine rehabilitation training and medication treatment', 'TOMT group and the scalp acupuncture', 'TOMT', 'dynamic scalp acupuncture combined with task-oriented mirror therapy (TOMT', 'scalp acupuncture', 'dynamic scalp acupuncture combined with task-oriented mirror therapy', 'TOMT during the scalp acupuncture treatment']","['simplified Fugl-Meyer assessment (FMA) scale upper limb part and functional test for the hemiplegic upper extremity-Hong Kong version (FTHUE-HK) grade, the muscle tension', 'MAS scores', 'modified Ashworth scale (MAS) and the activity ability of daily living was assessed by modified Barthel index (MBI', 'upper limb function', 'FMA scores, FTHUE-HK grades and MBI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",78.0,0.0257552,"After 4 weeks and 8 weeks of treatment, the FMA scores, FTHUE-HK grades and MBI scores in the dynamic scalp acupuncture group were better than those in the TOMT group and the scalp acupuncture group ( P <0.05), and these items in the scalp acupuncture group were better than those in the TOMT group ( P <0.05).
","[{'ForeName': 'Zheng-Lu', 'Initials': 'ZL', 'LastName': 'Yin', 'Affiliation': ""Department of Rehabilitation, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou 225002, Jiangsu Province, China.""}, {'ForeName': 'Zhao-Xiang', 'Initials': 'ZX', 'LastName': 'Meng', 'Affiliation': ""Department of Rehabilitation, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou 225002, Jiangsu Province, China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Ge', 'Affiliation': ""Department of Rehabilitation, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou 225002, Jiangsu Province, China.""}, {'ForeName': 'Min-Jie', 'Initials': 'MJ', 'LastName': 'Zhang', 'Affiliation': ""Department of Rehabilitation, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou 225002, Jiangsu Province, China.""}, {'ForeName': 'Ling-Hui', 'Initials': 'LH', 'LastName': 'Huang', 'Affiliation': ""Department of Rehabilitation, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou 225002, Jiangsu Province, China.""}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190819-0001']
2350,32959584,[Comparative study on effect of electroacupuncture at lower  he -sea point of stomach and  he -sea matching front- mu  points for gastroparesis].,"OBJECTIVE


To explore the efficacy difference of electroacupuncture at lower  he -sea point and  he -sea matching front- mu  points for the treatment of gastroparesis.
METHODS


A total of 63 patients with gastroparesis were randomly divided into a lower  he  point group (group A, 32 cases, 2 cases dropped off) and a  he  matching  mu  points group (group B, 31 cases, 1 case dropped off). The group A was treated with electroacupuncture at Zusanli (ST 36), and the group B was treated with electroacupuncture at Zusanli (ST 36) and Zhongwan (CV 12). Both groups were treated with continuous wave (2 Hz in frequency) for 30 min, once a day, 5 times a week for 3 weeks. The gastroparesis cardinal symptom index (GCSI) score, gastric half-emptying time (T 1/2 ) and the 180 min gastric residual rate of the two groups before and after treatment were observed, and the clinical effective rate was compared.
RESULTS


After treatment, the total GCSI scores, T 1/2  and the 180 min gastric residual rates in both groups were lower than those before treatment ( P <0.01), and the 180 min gastric residual rate and T 1/2  in the group A were lower than those in the group B ( P <0.05). The total effective rate was 93.3% (28/30) in the group A, which was superior to 70.0% (21/30) in the group B ( P <0.05).
CONCLUSION


Electroacupuncture at lower  he -sea point and  he -sea matching front- mu  points can both be used to treat gastroparesis, but electroacupuncture at Zusanli (ST 36) has a better effect. The acupoints of Zusanli (ST 36) and Zhongwan (CV 12) may have antagonistic effects.",2020,"After treatment, the total GCSI scores, T 1/2  and the 180 min gastric residual rates in both groups were lower than those before treatment ( P <0.01), and the 180 min gastric residual rate and T 1/2  in the group",['63 patients with gastroparesis'],"['electroacupuncture at Zusanli', 'electroacupuncture', 'Electroacupuncture', 'electroacupuncture at Zusanli (ST 36) and Zhongwan (CV 12']","['clinical effective rate', 'total GCSI scores, T 1/2  and the 180 min gastric residual rates', 'total effective rate', 'gastroparesis cardinal symptom index (GCSI) score, gastric half-emptying time (T 1/2 ) and the 180 min gastric residual rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0967114', 'cui_str': 'goblet cell silencer inhibitor'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3665864', 'cui_str': 'Gastric residual assessment'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",63.0,0.0257111,"After treatment, the total GCSI scores, T 1/2  and the 180 min gastric residual rates in both groups were lower than those before treatment ( P <0.01), and the 180 min gastric residual rate and T 1/2  in the group","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Shandong University of TCM, Jinan 250014, China.'}, {'ForeName': 'Hui-Qing', 'Initials': 'HQ', 'LastName': 'Ma', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Shandong University of TCM, Jinan 250014, China.'}, {'ForeName': 'Zhen-Jie', 'Initials': 'ZJ', 'LastName': 'Yang', 'Affiliation': 'Deparrtment of Acupuncture-Moxibustion and Tuina, Qilu Hospital of Shandong University, Jinan 250012.'}, {'ForeName': 'Hui-Ting', 'Initials': 'HT', 'LastName': 'Shao', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Shandong University of TCM, Jinan 250014, China.'}, {'ForeName': 'Gong-Lei', 'Initials': 'GL', 'LastName': 'Yue', 'Affiliation': 'Deparrtment of Acupuncture-Moxibustion and Tuina, Qilu Hospital of Shandong University, Jinan 250012.'}, {'ForeName': 'Guang-Zhong', 'Initials': 'GZ', 'LastName': 'Du', 'Affiliation': 'Deparrtment of Acupuncture-Moxibustion and Tuina, Qilu Hospital of Shandong University, Jinan 250012.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20191025-k0002']
2351,32959585,[Acupuncture based on meridian diagnosis for chronic atrophic gastritis].,"OBJECTIVE


To compare the efficacy between acupoint selection of meridian diagnosis and regular acupoint selection for chronic atrophic gastritis (CAG).
METHODS


A total of 70 cases of CAG were randomly divided into an observation group (35 cases, 5 cases dropped off) and a control group (35 cases, 5 dropped off). In the observation group, according to the hand diagnosis of meridians and the results of 80-channels energy determinator, based on the principle of child-mother relation acupoint combination, the  luo -connecting point and back- shu  points were added for excess syndrome, and the  yuan -primary point, front- mu  points and  he -sea point of foot meridians were added for deficiency syndrome; in addition, the acupoints of the eight extraordinary meridians were added based on the nature of acupoints. In the control group, Zhongwan (CV 12), Neiguan (PC 6), Zusanli (ST 36) and Gongsun (SP 4) were selected as the primary acupoints, and additional acupoints were added according to syndrome differentiation. The two groups were treated twice a week (Tuesday and Thursday, respectively), totally for 6 months. Six months after treatment, the follow-up was conducted. The clinical symptom score, gastroenteropathy patient reported outcomes (PRO) scale score before treatment, after treatment and during follow-up as well as the score of pathological changes of gastric mucosa before and after treatment were compared between the two groups.
RESULTS


After treatment and during follow-up, the clinical symptom scores and gastroenteropathy PRO scale scores were decreased in the two groups ( P <0.01,  P <0.001); at the follow-up, the gastroenteropathy PRO scale score in the observation group was lower than that in the control group ( P <0.01). After treatment, the scores of pathological changes of gastric mucosa in the two groups were decreased ( P <0.01), and the score in the observation group was lower than that in the control group ( P <0.05).
CONCLUSION


The acupoint selection of meridian diagnosis is superior to regular acupoint selection for CAG, which has better efficacy, more significant improvement on gastric mucosa pathology, and more stable long-term effect.",2020,"After treatment, the scores of pathological changes of gastric mucosa in the two groups were decreased ( P <0.01), and the score in the observation group was lower than that in the control group ( P <0.05).
","['chronic atrophic gastritis', 'A total of 70 cases of CAG', 'chronic atrophic gastritis (CAG']","['Acupuncture', 'meridian diagnosis and regular acupoint selection']","['gastroenteropathy PRO scale score', 'clinical symptom scores and gastroenteropathy PRO scale scores', 'gastric mucosa pathology', 'scores of pathological changes of gastric mucosa', 'outcomes (PRO) scale score', 'score of pathological changes of gastric mucosa']","[{'cui': 'C0017154', 'cui_str': 'Atrophic gastritis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0017178', 'cui_str': 'Disorder of gastrointestinal tract'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017136', 'cui_str': 'Gastric mucous membrane structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",70.0,0.0164594,"After treatment, the scores of pathological changes of gastric mucosa in the two groups were decreased ( P <0.01), and the score in the observation group was lower than that in the control group ( P <0.05).
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture-Moxibustion, Huguosi TCM Hospital of Beijing University of CM, Beijing 100035, China.'}, {'ForeName': 'Yu-Xiao', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture-Moxibustion, Huguosi TCM Hospital of Beijing University of CM, Beijing 100035, China.'}, {'ForeName': 'Yi-Xuan', 'Initials': 'YX', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture-Moxibustion, Huguosi TCM Hospital of Beijing University of CM, Beijing 100035, China.'}, {'ForeName': 'Rong-Dan', 'Initials': 'RD', 'LastName': 'Xue', 'Affiliation': 'Department of Acupuncture-Moxibustion, Huguosi TCM Hospital of Beijing University of CM, Beijing 100035, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture-Moxibustion, Huguosi TCM Hospital of Beijing University of CM, Beijing 100035, China.'}, {'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Cao', 'Affiliation': 'Department of Acupuncture-Moxibustion, Huguosi TCM Hospital of Beijing University of CM, Beijing 100035, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Department of Acupuncture-Moxibustion, Huguosi TCM Hospital of Beijing University of CM, Beijing 100035, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture-Moxibustion, Huguosi TCM Hospital of Beijing University of CM, Beijing 100035, China.'}, {'ForeName': 'Yu-Wei', 'Initials': 'YW', 'LastName': 'He', 'Affiliation': 'Department of Acupuncture-Moxibustion, Huguosi TCM Hospital of Beijing University of CM, Beijing 100035, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture-Moxibustion, Huguosi TCM Hospital of Beijing University of CM, Beijing 100035, China.'}, {'ForeName': 'Peng-Ran', 'Initials': 'PR', 'LastName': 'Song', 'Affiliation': 'Department of Acupuncture-Moxibustion, Huguosi TCM Hospital of Beijing University of CM, Beijing 100035, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190717-k0005']
2352,32959586,[Therapeutic effect on chronic obstructive pulmonary disease of lung  qi  deficiency at the stable stage treated with ginger-separated moxibustion and Chinese herbal medicine atomization].,"OBJECTIVE


To compare the clinical effect on chronic obstructive pulmonary disease (COPD) of lung  qi  deficiency at the stable stage treated with ginger-separated moxibustion and Chinese herbal medicine atomizaiton.
METHODS


A total of 90 patients with COPD of lung  qi  deficiency at the stable stage were randomized into an observation group (45 cases, 1 case dropped off) and a control group (45 cases, 2 cases dropped off). In the observation group, the ginger-separated moxibustion was applied to Dazhui (GV 14), Feishu (BL 13) and Gaohuangshu (BL 43), 2 moxa cones at each acupoint in each treatment. Additionally, the atomized inhalation with  bufei  decoction and  erchen  decoction was combined for 20 min, once every two days. The treatment for 10 times was taken as one course and 2 courses of treatment were required for 20 min. In the control group, ambroxol hydrochloride oral solution (10 mL) and compound methoxynamine capsules (2 capsules), were taken orally. Additionally, salbutamol aerosol was combined, 1 spray each time, three times a day, consecutively for 40 days. Before treatment and in 1-year followup after treatment, percentage of the forced expiratory volume in the first second predicated value (FEV1%) and its ratio to the forced vital capacity (FVC) (FEV1/FVC%) were determined in patients of the two groups. Before and after treatment, and in 3 months, 6 months and 1 year of followup after treatment, the score of COPD assessment test (CAT) and the score of traditional Chinese medicine (TCM) symptom were observed in the two groups separately. The clinical effect was assessed in 3-month followup after treatment and the frequency of the acute attack of COPD was followed up in 1 year after treatment in patients of the two groups.
RESULTS


In 1-year followup, FEV1% and FEV1/FVC% were increased in patients of the two groups ( P <0.05). After treatment and in the followup of 3 months, 6 months and 1 year after treatment, CAT scores were reduced as compared with thoes before treatment in the two groups successively ( P <0.01,  P <0.05). In 1-year followup after treatment, CAT score in the observation group was lower than the control group ( P <0.05). After treatment and in the followup of 3 months, 6 months and 1 year after treatment, the TCM symptom scores of cough, asthma, lassitude and spontaneous sweating were all reduced as compared with those before treatment in the observation group ( P <0.01), and the scores of cough and asthma were reduced as compared with those before treatment in the control group successively ( P <0.01,  P <0.05). After treatment and in the followup of 3 months, 6 months and 1 year after treatment, the scores of lassitude and spontaneous sweating in the observation group were lower than the control group successively ( P <0.01). In the followup of 6 months and 1 year after treatment, the scores of cough in the observation group were lower than the control group ( P <0.05). The total effective rates were 88.6% (39/44) in the observation group and 93.0% (40/43) in the control group, without significance difference ( P >0.05). In 1-year followup, the acute recurrence rate of COPD was 20.5% (9/44) in the observation group, lower than 32.6% (14/43) in the control group ( P <0.05).
CONCLUSION


As compared with western medication, the combination of ginger-separated moxibustion and Chinese herbal medicine atomizaiton achieves the superior effects of improving the lung functions, reducing the clinical symptoms and decreasing the frequency of acute attack in patients with COPD of lung  qi  deficiency at the stable stage.",2020,"In 1-year followup, FEV1% and FEV1/FVC% were increased in patients of the two groups ( P <0.05).",['90 patients with COPD of lung  qi  deficiency at the stable stage'],"['ambroxol hydrochloride oral solution (10 mL) and compound methoxynamine capsules', 'ginger-separated moxibustion and Chinese herbal medicine atomization', 'ginger-separated moxibustion and Chinese herbal medicine atomizaiton', 'atomized inhalation with  bufei  decoction and  erchen  decoction', 'salbutamol aerosol', 'ginger-separated moxibustion']","['score of COPD assessment test (CAT) and the score of traditional Chinese medicine (TCM) symptom', 'scores of cough and asthma', 'scores of lassitude and spontaneous sweating', 'percentage of the forced expiratory volume in the first second predicated value (FEV1%) and its ratio to the forced vital capacity (FVC) (FEV1/FVC', 'acute recurrence rate of COPD', 'CAT scores', 'lung functions', 'total effective rates', 'CAT score', 'scores of cough', 'FEV1% and FEV1/FVC', 'frequency of the acute attack of COPD', 'TCM symptom scores of cough, asthma, lassitude and spontaneous sweating']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C1367795', 'cui_str': 'Ambroxol hydrochloride'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0086525', 'cui_str': 'Lassitude'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",90.0,0.050031,"In 1-year followup, FEV1% and FEV1/FVC% were increased in patients of the two groups ( P <0.05).","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Shanghai Jing'an District Tianmu West Road Community Health Service Center, Shanghai 200070, China.""}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Shanghai University of TCM, Shanghai 201203; Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai 200030.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190903-0002']
2353,32959587,[Effect of  Fu 's subcutaneous needling on thickness and elasticity of affected muscles in shoulder neck pain based on ultrasonic elastography].,"OBJECTIVE


To observe the effect of  Fu 's subcutaneous needling on thickness and elasticity of affected muscles in subjects with shoulder neck pain by ultrasonic elastography.
METHODS


A total of 30 subjects with upper trapezius pain and local tenderness, or stiffness and funicular nodules were observed randomly, right shoulders were as observation group and left shoulders were as control group. Simple resistance training was adopted in the control group. At the same time of the resistance training, sweeping technique of  Fu 's subcutaneous needling was adopted at the local tenderness or the stiffness and funicular nodules of upper trapezius in the observation group. The treatment was given once in both groups. Before and immediately after treatment, thickness and elasticity of bilateral upper trapezius and supraspinatus were observed by ultrasonic elastography, and the variations of visual analogue scale (VAS) score were observed in the two groups.
RESULTS


Compared before treatment, the elasticity of upper trapezius and supraspinatus were decreased after treatment in both groups ( P <0.05), and those in the observation group were lower than the control group ( P <0.05). Compared before treatment, the VAS scores after treatment were decreased in both groups ( P <0.05), and that in the observation group was lower than the control group ( P <0.05).
CONCLUSION


Fu 's subcutaneous needling can increase the elasticity and release the muscular tension of affected muscles, and relieve pain in subjects with shoulder neck pain.",2020,"Compared before treatment, the elasticity of upper trapezius and supraspinatus were decreased after treatment in both groups ( P <0.05), and those in the observation group were lower than the control group ( P <0.05).","['30 subjects with upper trapezius pain and local tenderness, or stiffness and funicular nodules', 'subjects with shoulder neck pain by ultrasonic elastography', 'shoulder neck pain based on ultrasonic elastography', 'subjects with shoulder neck pain']","[""Fu 's subcutaneous needling"", 'Simple resistance training']","['VAS scores', 'thickness and elasticity of bilateral upper trapezius and supraspinatus', 'elasticity of upper trapezius and supraspinatus', 'variations of visual analogue scale (VAS) score']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1955928', 'cui_str': 'Tissue Elasticity Imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",30.0,0.0143048,"Compared before treatment, the elasticity of upper trapezius and supraspinatus were decreased after treatment in both groups ( P <0.05), and those in the observation group were lower than the control group ( P <0.05).","[{'ForeName': 'Yong-Hong', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Guangdong 999 Brain Hospital, Guangzhou 510510, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Guangdong 999 Brain Hospital, Guangzhou 510510, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Department of Rehabilitation, Guangdong 999 Brain Hospital, Guangzhou 510510, China.'}, {'ForeName': 'Fei-Yan', 'Initials': 'FY', 'LastName': 'Huang', 'Affiliation': 'Department of Rehabilitation, Guangdong 999 Brain Hospital, Guangzhou 510510, China.'}, {'ForeName': 'Chu-Rong', 'Initials': 'CR', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation, Guangdong 999 Brain Hospital, Guangzhou 510510, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190817-k0001']
2354,32959588,[Adjuvant therapy of  Wentong  acupuncture for elderly patients of primary osteoporosis with intestinal dysfunction: a randomized controlled trial].,"OBJECTIVE


To observe the effects of  Wentong  acupuncture on bone mineral density (BMD), bone metabolism and intestinal function in elderly patients of primary osteoporosis with intestinal dysfunction.
METHODS


A total of 128 elderly patients of primary osteoporosis with intestinal dysfunction were randomly divided into an observation group and a control group, 64 cases in each group. Patients in the control group were treated with oral administration of vitamin D calcium chewable tablets (0.6 g, once a day) and calcitriol capsules (0.25 μg, three times a day); the treatment was given for 6 months. On the basis of the treatment in the control group, patients in the observation group were additionally treated with  Wentong  acupuncture at Shenshu (BL 23), Mingmen (GV 4), Pishu (BL 20), Dachangshu (BL 25), Tianshu (ST 25) and Zusanli (ST 36), etc. for 30 min each time, once a day. After 1-week treatment, the patients took a rest for 2 days; the treatment was given for 6 months. Before and after treatment, the BMD of lumbar spine, femoral neck and femoral trochanter was detected by dual energy X-ray absorptiometry, and the serum levels of bone alkaline phosphatase (NBAP), osteocalcin (OC), matrix metalloproteinase-2 (MMP-2) and calcitonin (CT) were detected by ELISA method. The primary symptom scores of intestinal function, serum diamine oxidase (DAO) and D-lactic acid (D-Lac) levels were compared between the two groups before and after treatment, and the clinical efficacy of the two groups was evaluated.
RESULTS


The total effective rate was 85.9% (55/64) in the observation group, which was higher than 71.9% (46/64) in the control group ( P <0.05). After treatment, BMD were increased ( P <0.05), and serum bone metabolism indexes were improved in the two groups ( P <0.05); the BMD and serum bone metabolism indexes in the observation group were better than those in the control group ( P <0.05). After treatment, the primary symptom scores of intestinal function, serum DAO and D-Lac levels in the observation group were decreased ( P <0.05), and the indexes in the observation group were lower than those in the control group ( P <0.05).
CONCLUSION


The adjuvant therapy of  Wentong  acupuncture could increase BMD, improve bone metabolism and regulate intestinal function in elderly patients of primary osteoporosis with intestinal dysfunction.",2020,"After treatment, the primary symptom scores of intestinal function, serum DAO and D-Lac levels in the observation group were decreased ( P <0.05), and the indexes in the observation group were lower than those in the control group ( P <0.05).
","['elderly patients of primary osteoporosis with intestinal dysfunction', '128 elderly patients of primary osteoporosis with intestinal dysfunction']","['Wentong  acupuncture at Shenshu (BL 23), Mingmen (GV 4), Pishu (BL 20), Dachangshu (BL 25), Tianshu (ST 25) and Zusanli', 'calcitriol capsules', 'vitamin D calcium chewable tablets', 'Wentong  acupuncture']","['intestinal function, serum diamine oxidase (DAO) and D-lactic acid (D-Lac) levels', 'clinical efficacy', 'total effective rate', 'bone metabolism', 'primary symptom scores of intestinal function, serum DAO and D-Lac levels', 'serum levels of bone alkaline phosphatase (NBAP), osteocalcin (OC), matrix metalloproteinase-2 (MMP-2) and calcitonin (CT', 'serum bone metabolism indexes', 'BMD and serum bone metabolism indexes', 'BMD', 'BMD of lumbar spine, femoral neck and femoral trochanter', 'bone mineral density (BMD), bone metabolism and intestinal function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0410438', 'cui_str': 'Primary osteoporosis'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0304290', 'cui_str': 'Chewable tablet'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019587', 'cui_str': 'Amine oxidase (copper-containing)'}, {'cui': 'C3658295', 'cui_str': 'Propanoic Acid, 2-Hydroxy-, (2R)-'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023139', 'cui_str': 'Lauric acid'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0172537', 'cui_str': 'Gelatinase A'}, {'cui': 'C0006668', 'cui_str': 'Calcitonin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}]",128.0,0.0227336,"After treatment, the primary symptom scores of intestinal function, serum DAO and D-Lac levels in the observation group were decreased ( P <0.05), and the indexes in the observation group were lower than those in the control group ( P <0.05).
","[{'ForeName': 'Xiao-Qiang', 'Initials': 'XQ', 'LastName': 'Yao', 'Affiliation': 'Center of Acupuncture and Moxibustion, Affiliated Hospital of Gansu University of CM, Lanzhou 730000, China; Gansu Provincial Huangfumi Acupuncture Hospital, Lanzhou 730000.'}, {'ForeName': 'Xian-Li', 'Initials': 'XL', 'LastName': 'Zheng', 'Affiliation': 'Center of Acupuncture and Moxibustion, Affiliated Hospital of Gansu University of CM, Lanzhou 730000, China; Gansu Provincial Huangfumi Acupuncture Hospital, Lanzhou 730000.'}, {'ForeName': 'Jia-Xing', 'Initials': 'JX', 'LastName': 'Gao', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Gansu University of CM.'}, {'ForeName': 'Ya-Jie', 'Initials': 'YJ', 'LastName': 'Zhou', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Gansu University of CM.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20191205-0005']
2355,32951337,Validation of the clinical applicability of knowledge-based planning models in single-isocenter volumetric-modulated arc therapy for multiple brain metastases.,"PURPOSE


To validate the clinical applicability of knowledge-based (KB) planning in single-isocenter volumetric-modulated arc therapy (VMAT) for multiple brain metastases using the k-fold cross-validation (CV) method.
METHODS


This study comprised 60 consecutive patients with multiple brain metastases treated with single-isocenter VMAT (28 Gy in five fractions). The patients were divided randomly into five groups (Groups 1-5). The data of Groups 1-4 were used as the training and validation dataset and those of Group 5 were used as the testing dataset. Four KB models were created from three of the training and validation datasets and then applied to the remaining Groups as the fourfold CV phase. As the testing phase, the final KB model was applied to Group 5 and the dose distributions were calculated with a single optimization process. The dose-volume indices (DVIs), modified Ian Paddick Conformity Index (mIPCI), modulation complexity scores for VMAT plans (MCSv), and the total number of monitor units (MUs) of the final KB plan were compared to those of the clinical plan (CL) using a paired Wilcoxon signed-rank test.
RESULTS


In the fourfold CV phase, no significant differences were observed in the DVIs among the four KB plans (KBPs). In the testing phase, the final KB plan was statistically equivalent to the CL, except for planning target volumes (PTVs) D 2%  and D 50%  . The differences between the CL and KBP in terms of the PTV D 99.5%  , normal brain, and D max  to all organs at risk (OARs) were not significant. The KBP achieved a lower total number of MUs and higher MCSv than the CL with no significant difference.
CONCLUSIONS


We demonstrated that a KB model in a single-isocenter VMAT for multiple brain metastases was equivalent in dose distribution, MCSv, and total number of MUs to a CL with a single optimization.",2020,"In the testing phase, the final KB plan was statistically equivalent to the CL, except for planning target volumes (PTVs)","['multiple brain metastases', '60 consecutive patients with multiple brain metastases treated with single-isocenter VMAT (28\xa0Gy in five fractions']",['knowledge-based (KB) planning in single-isocenter volumetric-modulated arc therapy (VMAT'],"['total number of MUs and higher MCSv', 'dose-volume indices (DVIs), modified Ian Paddick Conformity Index (mIPCI), modulation complexity scores for VMAT plans (MCSv), and the total number of monitor units (MUs) of the final KB plan', 'normal brain, and D max  to all organs at risk (OARs', 'planning target volumes (PTVs']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]","[{'cui': 'C0022752', 'cui_str': 'Knowledge Bases (Computer)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3489631', 'cui_str': 'Intensity-Modulated Arc Therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0022752', 'cui_str': 'Knowledge Bases (Computer)'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}, {'cui': 'C0454199', 'cui_str': 'Planning target volume'}]",60.0,0.0117103,"In the testing phase, the final KB plan was statistically equivalent to the CL, except for planning target volumes (PTVs)","[{'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Kishi', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Hirashima', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Mukumoto', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Takehana', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Uto', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Matsuo', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mizowaki', 'Affiliation': 'Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Journal of applied clinical medical physics,['10.1002/acm2.13022']
2356,32951358,Efficacy and Safety of Tocilizumab for Polyarticular-Course Juvenile Idiopathic Arthritis in the Open-Label 2-Year Extension of a Phase 3 Trial.,"OBJECTIVE


Report the 2-year efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis (pcJIA).
METHODS


Patients 2 to 17 years of age with active pcJIA whose treatment with methotrexate failed received 16 weeks of open-label intravenous tocilizumab in part 1 (every 4 weeks: 8 mg/kg or 10 mg/kg for body weight [BW] <30 kg; 8 mg/kg for BW ≥30 kg). Patients with ≥JIA-ACR30 response at week 16 were randomly assigned (1:1) to receive tocilizumab or placebo in part 2. Patients remained in part 2 until week 40 or occurrence of JIA flare. On starting part 3, all patients received open-label tocilizumab. At week 104 of the study, efficacy was assessed using JIA-ACR50/70/90 response rates, achievement of inactive disease, and Juvenile Arthritis Disease Activity Score-71 (JADAS-71). Safety was assessed in the all-exposure population per 100 patient-years (PY) of exposure.
RESULTS


Overall, 188 patients entered part 1, 166 part 2, and 160 part 3. At week 104, among 188 patients in the modified-intent-to-treat group who received tocilizumab, JIA-ACR50/70/90 response rates were 80.3%/77.1%/59.6%; median JADAS-71 decreased from 3.6 at week 40 to 0.7 at week 104; 51.1% of patients achieved inactive disease; and 31 of 66 patients who were receiving glucocorticoids discontinued them. Adverse event (AE) and serious AE rates were 406.5/100PY and 11.1/100PY. Infections rates were 151.4/100PY and serious infections rates were 5.2/100PY.
CONCLUSION


Patients treated with tocilizumab for pcJIA showed high-level disease control for up to 2 years. The tocilizumab safety profile was consistent with that previously reported.",2020,Adverse event (AE) and serious AE rates were 406.5/100PY and 11.1/100PY.,"['Patients 2 to 17 years of age with active pcJIA whose treatment with', 'Polyarticular-Course Juvenile Idiopathic Arthritis', 'Patients with ≥JIA-ACR30 response at week 16', '188 patients entered part 1, 166 part 2, and 160 part 3', 'patients with polyarticular-course juvenile idiopathic arthritis (pcJIA']","['Tocilizumab', 'open-label tocilizumab', 'tocilizumab', 'methotrexate failed received 16 weeks of open-label intravenous tocilizumab', 'tocilizumab or placebo']","['Safety', 'median JADAS-71', 'Adverse event (AE) and serious AE rates', 'Infections rates', 'Efficacy and Safety', '2-year efficacy and safety', 'high-level disease control', 'JIA-ACR50/70/90 response rates, achievement of inactive disease, and Juvenile Arthritis Disease Activity Score-71 (JADAS-71']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0240789', 'cui_str': 'Polyarticular'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]",188.0,0.0902528,Adverse event (AE) and serious AE rates were 406.5/100PY and 11.1/100PY.,"[{'ForeName': 'Hermine I', 'Initials': 'HI', 'LastName': 'Brunner', 'Affiliation': ""Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Nicolino', 'Initials': 'N', 'LastName': 'Ruperto', 'Affiliation': 'Istituto Giannina Gaslini, Pediatria II, Rheumatologia, Paediatric Rheumatology International Trials Organisation (PRINTO) Coordinating Centre, Genoa, Italy.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Zuber', 'Affiliation': 'Andrzej Frycz Modrzewski Krakow University, Kracow, Poland.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Cuttica', 'Affiliation': 'Hospital General de Niños Pedro de Elizalde, Buenos Aires, Argentina.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Keltsev', 'Affiliation': 'Department of Pediatric Cardiology and Rheumatology, Samara Regional Clinical Hospital, Samara, Russia.'}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Xavier', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Burgos-Vargas', 'Affiliation': 'Hospital General de México and Universidad Nacional Autónoma de México, Mexico City, Mexico.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Calvo Penades', 'Affiliation': 'Paediatric Rheumatology Department, Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Earl D', 'Initials': 'ED', 'LastName': 'Silverman', 'Affiliation': 'Department of Paediatrics, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Graciela', 'Initials': 'G', 'LastName': 'Espada', 'Affiliation': 'Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ferrandiz Zavaler', 'Affiliation': 'Rheumatology Service, Instituto Nacional de Salud del Niño, Lima, Perú, Peru.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': ""Department of Pediatrics, Section of Rheumatology, , Joseph M. Sanzari Children's Hospital, Hackensack Meridian School of Medicine, Hackensack, NJ, USA.""}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Duarte', 'Affiliation': 'Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra, Mexico City, Mexico.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Job-Deslandre', 'Affiliation': 'Service de Rhumatologie A, Hôpital Cochin, AP-HP, Université Paris-Descartes, Paris, France.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Joos', 'Affiliation': 'ZNA Jan Palfijn Antwerpen, Antwerp, University Hospital, Ghent, Belgium.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Douglass', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Sunethra', 'Initials': 'S', 'LastName': 'Wimalasundera', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Kamal N', 'Initials': 'KN', 'LastName': 'Bharucha', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wells', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lovell', 'Affiliation': ""Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Martini', 'Affiliation': 'Istituto Giannina Gaslini, Pediatria II, Rheumatologia, Paediatric Rheumatology International Trials Organisation (PRINTO) Coordinating Centre, Genoa, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'De Benedetti', 'Affiliation': 'IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41528']
2357,32951360,Attended vs unattended systolic blood pressure measurement: A randomized comparison in patients with cardiovascular disease.,"Recent clinical guidelines recommend lower blood pressure (BP) goals for most patients, and recent trends have favored use of automated unattended BP measurements in the office setting to minimize observer error and white-coat effects. Patients attending a routinely scheduled CVD clinic visit were prospectively randomized to BP measured using an attended, followed by an unattended method, or vice versa, after a controlled rest period. All study BP measurements were obtained in triplicate using the automated Omron HEM-907XL BP monitor, and averaged. The outcome was difference in SBP. Routinely measured clinic BP from the same visit was extracted from the medical record, and compared with attended and unattended BP. A total of 102 patients were randomized, and mean age was 63 years, 52% female and 75% Caucasian. Attended and unattended SBP was 125.4 ± 20.4 and 122.6 ± 21.0 mm Hg, mean ± SD, respectively. Routine clinic SBP was 130.6 ± 23.6 mm Hg. Attended SBP was 2.7 mm Hg higher than the unattended measurement (95% CI 1.3-4.1; P = .0002). Routine clinic SBP was 5.2 mm Hg higher than attended SBP (95% CI 2.4-8.0; P = .0003) and 8.0 mm Hg higher than unattended SBP (95% CI 5.4-10.5; P < .0001). Attended measurement of BP is significantly higher than unattended measurement and the difference is physiologically meaningful, even in a CVD cohort with generally well-controlled hypertension. Furthermore, routine clinic SBP substantially overestimates both attended and unattended automated SBP, with important implications for treatment decisions like dose and/or drug escalation.",2020,Attended SBP was 2.7 mm Hg higher than the unattended measurement (95% CI 1.3-4.1; P = .0002).,"['Patients attending a routinely scheduled CVD clinic visit', 'A total of 102 patients were randomized, and mean age was 63\xa0years, 52% female and 75% Caucasian', 'patients with cardiovascular disease']",[],"['blood pressure (BP) goals', 'Attended SBP', 'systolic blood pressure measurement', 'clinic BP', 'SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C1306620', 'cui_str': 'Blood pressure systolic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",102.0,0.0648411,Attended SBP was 2.7 mm Hg higher than the unattended measurement (95% CI 1.3-4.1; P = .0002).,"[{'ForeName': 'Ellen C', 'Initials': 'EC', 'LastName': 'Keeley', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Villanueva', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, Gainesville, FL, USA.'}, {'ForeName': 'Yiqing E', 'Initials': 'YE', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, Gainesville, FL, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, Gainesville, FL, USA.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Handberg', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'Department of Pharmacotherapy and Translational Research, College of Pharmacy, Gainesville, FL, USA.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Pepine', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Rhonda M', 'Initials': 'RM', 'LastName': 'Cooper-DeHoff', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, College of Medicine, Gainesville, FL, USA.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.14037']
2358,32951537,Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline: The COMPASS MRI Substudy.,"BACKGROUND AND PURPOSE


Covert brain infarcts are associated with cognitive decline. It is not known whether therapies that prevent symptomatic stroke prevent covert infarcts. COMPASS compared rivaroxaban with and without aspirin with aspirin for the prevention of stroke, myocardial infarction, and vascular death in participants with stable vascular disease and was terminated early because of benefits of rivaroxaban 2.5 mg twice daily plus aspirin over aspirin. We obtained serial magnetic resonance imagings and cognitive tests in a consenting subgroup of COMPASS patients to examine treatment effects on infarcts, cerebral microbleeds, and white matter hyperintensities.
METHODS


Baseline and follow-up magnetic resonance imagings were completed in 1445 participants with a mean (SD) interval of 2.0 (0.7) years. Whole-brain T1, T2 fluid-attenuated inversion recovery, T2* sequences were centrally interpreted by blinded, trained readers. Participants had serial measurements of cognition and function. The primary end point was the proportion of participants with incident covert infarcts. Secondary end points were the composite of clinical stroke and covert brain infarcts, cerebral microbleeds, and white matter hyperintensities.
RESULTS


At baseline, 493 (34.1%) participants had infarcts. Incident covert infarcts occurred in 55 (3.8%) participants. In the overall trial rivaroxaban plus aspirin reduced ischemic stroke by 49% (0.7% versus 1.4%; hazard ratio [95% CI], 0.51 [0.38-0.68]). In the magnetic resonance imaging substudy the effects of rivaroxaban+aspirin versus aspirin were: covert infarcts: 2.7% versus 3.5% (odds ratio [95% CI], 0.77 [0.37-1.60]); Covert infarcts or ischemic stroke: 2.9% versus 5.3% (odds ratio [95% CI], 0.53 [0.27-1.03]). Incident microbleeds occurred in 6.6% of participants and 65.7% of participants had an increase in white matter hyperintensities volume with no effect of treatment for either end point. There was no effect on cognitive tests.
CONCLUSIONS


Covert infarcts were not significantly reduced by treatment with rivaroxaban and aspirin but estimates for the combination of ischemic stroke and covert infarcts were consistent with the effect on ischemic stroke in the overall trial.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01776424.",2020,"In the overall trial rivaroxaban plus aspirin reduced ischemic stroke by 49% (0.7% versus 1.4%; hazard ratio [95% CI], 0.51 [0.38-0.68]).","['1445 participants with a mean (SD) interval of 2.0 (0.7) years', 'participants with stable vascular disease', 'consenting subgroup of COMPASS patients']","['rivaroxaban', 'aspirin with aspirin', 'aspirin over aspirin', 'rivaroxaban plus aspirin', 'Rivaroxaban', 'rivaroxaban+aspirin versus aspirin', 'aspirin']","['Incident covert infarcts', 'composite of clinical stroke and covert brain infarcts, cerebral microbleeds, and white matter hyperintensities', 'proportion of participants with incident covert infarcts', 'white matter hyperintensities volume', 'serial measurements of cognition and function', 'ischemic stroke', 'stroke, myocardial infarction, and vascular death', 'Covert infarcts or ischemic stroke', 'Incident microbleeds', 'cognitive tests']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0751955', 'cui_str': 'Brain Infarct'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",1445.0,0.524355,"In the overall trial rivaroxaban plus aspirin reduced ischemic stroke by 49% (0.7% versus 1.4%; hazard ratio [95% CI], 0.51 [0.38-0.68]).","[{'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Smith', 'Affiliation': 'Hotchkiss Brain Institute, University of Calgary, AB, Canada (E.E.S.).'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Reeh', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Casanova', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clinicos Latino America and Instituto Cardiovascular de Rosario, Argentina (R.D.).'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Research Institute, FOSCAL-Bucaramanga, Colombia (P.L.-J.).'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Ertl', 'Affiliation': 'Comprehensive Heart Failure Center, University and University Hospital, Würzburg, Germany (G.E., S.S.).'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Störk', 'Affiliation': 'Comprehensive Heart Failure Center, University and University Hospital, Würzburg, Germany (G.E., S.S.).'}, {'ForeName': 'Gilles R', 'Initials': 'GR', 'LastName': 'Dagenais', 'Affiliation': 'Institut Universitaire de Cardiologie et Pneumologie de Quebec, Quebec City, Canada (G.R.D.).'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Lonn', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ryden', 'Affiliation': 'Karolinska Institutet, Stockholm, Sweden (L.R.).'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'Monash University, Melbourne, Australia (A.M.T., J.D.V.).'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Varigos', 'Affiliation': 'Monash University, Melbourne, Australia (A.M.T., J.D.V.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard, Medical School, Boston, MA (D.L.B.).""}, {'ForeName': 'Kelley R H', 'Initials': 'KRH', 'LastName': 'Branch', 'Affiliation': 'University of Washington Medical Centre, Seattle (K.R.H.B.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Probstfield', 'Affiliation': 'University of Washington, Seattle (K.R.H.B., J.L.P.).'}, {'ForeName': 'Jae-Hyung', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'The Catholic University of Korea, Seoul, Korea (J.-H.K.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': ""O'Donnell"", 'Affiliation': 'National University of Ireland Galway, Galway, Ireland (M.O.).'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': 'University of Medicine and Pharmacology Carol Davila University and Emergency Hospital, Bucharest, Romania (D.V.).'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'Centre for Cardiovascular Science, University of Edinburgh, Scotland, United Kingdom (K.A.A.F.).'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'FuWai Hospital, Beijing, China (Y.L., L.L., J.Z.).'}, {'ForeName': 'Lisheng', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'FuWai Hospital, Beijing, China (Y.L., L.L., J.Z.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'FuWai Hospital, Beijing, China (Y.L., L.L., J.Z.).'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Research Centre for Preventative Medicine, Moscow, Russia (N.P.).'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy (A.P.M.).'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, Sao Paulo, Brazil (A.A.).'}, {'ForeName': 'Leopoldo S', 'Initials': 'LS', 'LastName': 'Piegas', 'Affiliation': 'University of Sao Paulo, Sao Paulo, Brazil (L.S.P.).'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Budapest, Hungary (K.K., M.K.).'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Budapest, Hungary (K.K., M.K.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer AG, Leverkusen, Germany (S.D.B.).'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, ON, Canada (M.S., R.G.H., J.B., J.W.E., S.J.C., L.D., K.W.R., A.C., E.M.L., S.Y.).'}]",Stroke,['10.1161/STROKEAHA.120.029762']
2359,32951706,Progressive muscle-strength protocol for the functionality of upper limbs and quality of life in individuals with Parkinson's disease: Pilot study.,"The effects of physical-therapy intervention on the motor function of upper limbs and the quality of life in patients with Parkinson's disease (PD) are not fully understood. We evaluated the effects of a progressive muscle-strengthening protocol for upper limbs on the functionality and quality of life. Patients were divided into two groups: Intervention (n = 6) and Control (n = 7). Assessment tools used were: Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Questionnaire, Nine-Hole Peg Test (9HPT), Test d'Évaluation des Membres Supérieurs de Personnes Âgées (TEMPA), 10-Repetition Maximum (10-RM) and handgrip dynamometer, which were applied pre- and post-intervention, with follow-up for one month after the last training session. Only, the Intervention group (post-intervention) showed significant statistical differences, with the following outcomes: UPDRS III (p = 0.042); 9HPT, right (p = 0.028) and left side (p = 0.028); TEMPA for total right side (p = 0.028), left side (p = 0.028) and total bilateral tasks (p = 0.028); TEMPA task 2 - open a jar and take a spoonful of coffee (p = 0.028), task 3 - pick up a pitcher and pour water into a glass for right (p = 0.046) and left side (p = 0.028), task 5 - write on an envelope and stick on a stamp (p = 0.028), and task 6 - shuffle and deal playing cards (p = 0.028). We observed significant statistical differences between groups (post-intervention) for TEMPA task 6 (p = 0.032), total right side (p = 0.032), and total bilateral tasks (p = 0.032). An increase in the maximum load in the post-intervention stage, based on the 10-RM test, was observed on the right (p = 0.003) and left (p = 0.007) sides. Our results showed an improvement in upper-limb functionality in PD patients submitted to progressive muscle-strength training, although not in quality of life.",2020,"We observed significant statistical differences between groups (post-intervention) for TEMPA task 6 (p = 0.032), total right side (p = 0.032), and total bilateral tasks (p = 0.032).","[""individuals with Parkinson's disease"", ""patients with Parkinson's disease (PD""]","['progressive muscle-strengthening protocol', 'Progressive muscle-strength protocol', 'physical-therapy intervention']","['maximum load', 'total right side', 'functionality and quality of life', 'total bilateral tasks', 'upper-limb functionality', 'left side', 'motor function of upper limbs and the quality of life', ""Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Questionnaire, Nine-Hole Peg Test (9HPT), Test d'Évaluation des Membres Supérieurs de Personnes Âgées (TEMPA), 10-Repetition Maximum (10-RM) and handgrip dynamometer""]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}]",,0.0106682,"We observed significant statistical differences between groups (post-intervention) for TEMPA task 6 (p = 0.032), total right side (p = 0.032), and total bilateral tasks (p = 0.032).","[{'ForeName': 'Thais Vianna', 'Initials': 'TV', 'LastName': 'Correa', 'Affiliation': 'Graduate Program of Physical Education, Universidade Federal do Rio de Janeiro, Brazil; Institute of Neurology Deolindo Couto, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'da Silva Rocha Paz', 'Affiliation': 'Graduate Program of Physical Education, Universidade Federal do Rio de Janeiro, Brazil; Institute of Neurology Deolindo Couto, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Allodi', 'Affiliation': 'Graduate Program of Physiology, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Vera Lúcia Santos', 'Initials': 'VLS', 'LastName': 'de Britto', 'Affiliation': 'Graduate Program of Physical Education, Universidade Federal do Rio de Janeiro, Brazil; Institute of Neurology Deolindo Couto, Universidade Federal do Rio de Janeiro, Brazil.'}, {'ForeName': 'Clynton Lourenço', 'Initials': 'CL', 'LastName': 'Correa', 'Affiliation': 'Graduate Program of Physical Education, Universidade Federal do Rio de Janeiro, Brazil; Institute of Neurology Deolindo Couto, Universidade Federal do Rio de Janeiro, Brazil. Electronic address: clyntoncorrea@hucff.ufrj.br.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102432']
2360,32951708,The effects of eugenol nanoemulsion on pain caused by arteriovenous fistula cannulation in hemodialysis patients: A randomized double-blinded controlled cross-over trial.,"OBJECTIVES


Local anesthetic and antinociceptive activity of eugenol, as the main ingredient of clove, was determined in previous researches. This study aimed to assess the efficacy of its topical nanoemulsion gel vs. placebo in controlling pain caused by arteriovenous fistula (AVF) needling in patients undergoing hemodialysis (HD).
DESIGN


In this double-blinded cross-over trial, the patients were randomly allocated to eugenol gel 4% (n = 34) and placebo gel (n  = 34) groups. For each patient, a tip of finger unit of gel was applied 2 cm around the insertion site of hemodialysis needles. After 10 min, AVF needling was done. AVF needling-related pain was assessed using visual analogue scale (VAS) immediately after the puncture. All patients were tested at three different states: (1) before using any intervention; (2) after using either the eugenol or placebo gel; and (3) after crossing over the groups.
RESULTS


There was a significant difference between the mean of patients' pain severity score in the three states (p = 0.001). It was reported as low as 3.29 ± 0.67 in patients who received eugenol nanoemulsion. Also, the highest pain severity score (5.03 ± 0.57) was reported at the no-intervention state.
CONCLUSIONS


It seems that topical application of eugenol nanoemulsion may significantly decrease AVF cannulation related pain intensity score in patients undergoing HD. However, further studies with larger sample size and longer intervention period should be done for better judgment on its efficiency and safety.",2020,There was a significant difference between the mean of patients' pain severity score in the three states (p = 0.001).,"['hemodialysis patients', 'patients undergoing HD', 'patients undergoing hemodialysis (HD']","['eugenol gel', 'AVF needling', 'eugenol nanoemulsion', 'placebo gel', 'eugenol or placebo gel', 'topical nanoemulsion gel vs. placebo']","['visual analogue scale (VAS', ""mean of patients' pain severity score"", 'AVF needling-related pain', 'highest pain severity score', 'AVF cannulation related pain intensity score', 'pain']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015153', 'cui_str': 'Eugenol'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.232089,There was a significant difference between the mean of patients' pain severity score in the three states (p = 0.001).,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Maghbool', 'Affiliation': 'Department of Pathology, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Tomaj', 'Initials': 'T', 'LastName': 'Khosravi', 'Affiliation': 'Student Research Committee, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Vojdani', 'Affiliation': 'Department of Anesthesiology, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Mahsa Rostami', 'Initials': 'MR', 'LastName': 'Chaijan', 'Affiliation': 'Department of Persian Medicine, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Esmaeili', 'Affiliation': 'Department of Medical Nanotechnology, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Amani', 'Affiliation': 'Natural Products and Medicinal Plants Research Center, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rezayat', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nasimi Doost Azgomi', 'Affiliation': 'Traditional Medicine, Hydrotherapy Research Center, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Shadan S', 'Initials': 'SS', 'LastName': 'Mehraban', 'Affiliation': 'Department of Obstetrics and Gynecology, Richmond University Medical Center, Staten Island, NY, USA.'}, {'ForeName': 'Mohammad Hashem', 'Initials': 'MH', 'LastName': 'Hashempur', 'Affiliation': 'Department of Persian Medicine, Fasa University of Medical Sciences, Fasa, Iran; Noncommunicable Diseases Research Center, Fasa University of Medical Sciences, Fasa, Iran. Electronic address: hashempur@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102440']
2361,32951710,Use of l-3-n-Butylphthalide within 24 h after intravenous thrombolysis for acute cerebral infarction.,"OBJECTIVE


Observe the clinical efficacy of l-3-n-Butylphthalide (NBP) in acute ischemic stroke (AIS) patients within 24 h after intravenous thrombolysis using recombinant tissue plasminogen activator (hereafter termed ""IT"").
METHODS


One-hundred and seventy-eight patients with AIS were divided randomly into two groups: NBP and control. The former was given a NBP injection within 24 h after IT. After intravenous injection of NBP for 8-10 days, patients switched to soft capsules of NBP before or during meals. NBP treatment was continued for ≥30 days after hospital discharge. In the control group, NBP was not injected within 24 h after IT, and NBP capsules were not given after 8-10 days. Both groups were reviewed for CT or MRI 24 h after IT. The National Institutes of Health Stroke Scale (NIHSS) score was calculated. The number of patients with a modified Rankin scale (mRS) 0-2 before, 24 h, and 90 days after IT was documented. Prevalence of cerebral hemorrhage and reocclusion of blood vessels after IT was calculated.
RESULTS


There were no differences in sex, age, blood pressure, blood glucose, or cerebral-infarction types between the two groups before treatment. The NIHSS score 24 h after IT and the percentage of mRS scores 0-2 were not significantly different between the two groups. Compared with the control group, the NIHSS score in the NBP group was significantly improved at 90 days, and the number of patients with a mRS score 0-2 increased significantly. There was no significant difference in hemorrhage prevalence after IT between the two groups. Prevalence of blood-vessel occlusion after IT was significantly lower in the NBP group than that in the control group.
CONCLUSION


Use of NBP within 24 h after IT can reduce the prevalence of reocclusion of blood vessels without increasing the risk of cerebral hemorrhage.",2020,The NIHSS score 24 h after IT and the percentage of mRS scores 0-2 were not significantly different between the two groups.,"['acute cerebral infarction', 'One-hundred and seventy-eight patients with AIS', 'acute ischemic stroke (AIS) patients within 24 h after intravenous thrombolysis using']","['recombinant tissue plasminogen activator', 'l-3-n-Butylphthalide (NBP', 'l-3-n-Butylphthalide', 'NBP and control', 'NBP']","['Prevalence of blood-vessel occlusion', 'sex, age, blood pressure, blood glucose, or cerebral-infarction types', 'Health Stroke Scale (NIHSS) score', 'prevalence of reocclusion of blood vessels', 'percentage of mRS scores', 'cerebral hemorrhage and reocclusion of blood vessels', 'NIHSS score', 'hemorrhage prevalence']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0604267', 'cui_str': 'L-3'}, {'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0854571', 'cui_str': 'Reocclusion'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",178.0,0.0189759,The NIHSS score 24 h after IT and the percentage of mRS scores 0-2 were not significantly different between the two groups.,"[{'ForeName': 'Mingzhe', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: neurologywangmingzhe@shutcm.edu.cn.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of General Surgery, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: Fengyu@shutcm.edu.com.'}, {'ForeName': 'Yike', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: yikiyuan@163.com.'}, {'ForeName': 'Liqing', 'Initials': 'L', 'LastName': 'Gui', 'Affiliation': 'Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: betty_glq@126.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'North Bund Community Health Center, Hongkou District, Shanghai, 200080, China. Electronic address: 1263506323@qq.com.'}, {'ForeName': 'Penglin', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: a2854272039@qq.com.'}, {'ForeName': 'Baofeng', 'Initials': 'B', 'LastName': 'Qin', 'Affiliation': 'Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: sgyy2138@shutcm.edu.cn.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Sima', 'Affiliation': 'Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: 1746485080@qq.com.'}, {'ForeName': 'Qiudong', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Integrative Neurology, Pudong Traditional Chinese Medicine Hospital, Shanghai, 200000, China. Electronic address: drwangqiudong@163.com.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: panwd@medmail.com.cn.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102442']
2362,32951711,Feasibility analysis of external application of Xiao-Shuan-San in preventing PICC-related thrombosis.,"PURPOSE


We aim to analyze the feasibility of external application of Xiao-Shuan-Santo prevent peripherally inserted central catheter (PICC) -related thrombosis.
METHODS


A total of 218 patients with PICC catheterization were randomly divided into a control group (n = 103) and a treatment group (n = 115). Patients in the treatment group received additional external application of Xiao-Shuan-San. The changes of coagulation index, the incidence of PICC-related thrombosis and other complications, and the maximum blood flow rate (Vmax) of axillary vein were observed at 1 day before catheterization and 30 days after PICC.
RESULTS


At 30 days after PICC, the incidence of PICC-related thrombosis and other adverse events in the treatment group were obviously lower than that in the control group (P < 0.05), and the decreased Vmax value of axillary vein in the control group (11.75±1.91 cm/s) was more visible than that in the treatment group (14.63±3.03 cm/s), accompanied by a statistical significance (P < 0.05).
CONCLUSIONS


External application of Xiao-Shuan-San could reduce the incidence of PICC-related thrombosis and other complications.",2020,"The changes of coagulation index, the incidence of PICC-related thrombosis and other complications, and the maximum blood flow rate (Vmax) of axillary vein were observed at 1 day before catheterization and 30 days after PICC.
",['218 patients with PICC catheterization'],"['external application of Xiao-Shuan-San', 'additional external application of Xiao-Shuan-San', 'Xiao-Shuan-Santo']","['incidence of PICC-related thrombosis and other adverse events', 'changes of coagulation index, the incidence of PICC-related thrombosis and other complications, and the maximum blood flow rate (Vmax) of axillary vein', 'Vmax value of axillary vein']","[{'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0004456', 'cui_str': 'Structure of axillary vein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",218.0,0.0273837,"The changes of coagulation index, the incidence of PICC-related thrombosis and other complications, and the maximum blood flow rate (Vmax) of axillary vein were observed at 1 day before catheterization and 30 days after PICC.
","[{'ForeName': 'Jie-Ping', 'Initials': 'JP', 'LastName': 'Li', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, Yuhuangding Hospital Affiliated to Qingdao University, Yantai, 264000, China.'}, {'ForeName': 'Wen-Wen', 'Initials': 'WW', 'LastName': 'Jiang', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, Yuhuangding Hospital Affiliated to Qingdao University, Yantai, 264000, China; Centre of Integrated Chinese and Western Medicine, School of Basic Medicine, Qingdao University, Qingdao, 266071, China.'}, {'ForeName': 'Wei-Kang', 'Initials': 'WK', 'LastName': 'Bi', 'Affiliation': 'Department of Clinical Medicine, Weifang Medical University, Weifang, 261000, China.'}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Jiang', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, Yuhuangding Hospital Affiliated to Qingdao University, Yantai, 264000, China.'}, {'ForeName': 'Ze-Kun', 'Initials': 'ZK', 'LastName': 'Li', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, Yuhuangding Hospital Affiliated to Qingdao University, Yantai, 264000, China; Centre of Integrated Chinese and Western Medicine, School of Basic Medicine, Qingdao University, Qingdao, 266071, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, Yuhuangding Hospital Affiliated to Qingdao University, Yantai, 264000, China.'}, {'ForeName': 'Shao-Bing', 'Initials': 'SB', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Medicine, Weifang Medical University, Weifang, 261000, China.'}, {'ForeName': 'Ming-Jun', 'Initials': 'MJ', 'LastName': 'Bi', 'Affiliation': 'Emergency Center, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, 264000, China. Electronic address: bimingjun00@163.com.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, Yuhuangding Hospital Affiliated to Qingdao University, Yantai, 264000, China; Centre of Integrated Chinese and Western Medicine, School of Basic Medicine, Qingdao University, Qingdao, 266071, China. Electronic address: liqin701015@163.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102448']
2363,32951712,Vacuum myofascial therapy device for non-specific neck pain. A single blind randomized clinical trial.,"OBJECTIVES


This study aimed to investigate the efficacy of a vacuum myofascial therapy device (VT) for improving pressure pain thresholds (PPTs), range of motion (ROM), neck pain-related disability, pain, and quality of life in patients with non-specific neck pain.
METHODS


A randomized controlled trial in which thirty-eight participants with non-specific neck pain (NP) were randomly assigned to either an experimental (VT) or a comparison physical therapy program (PTP) group. The VT group (n = 19) received five sessions of treatment with a vacuum myofascial therapy device while the PTP group (n = 19) received five sessions of massage, ultrasound therapy (US), and transcutaneous electric nerve stimulation (TENS) over two weeks. The outcome measures were the numerical pain rating scale (NPRS), range of motion, quality of life (SF-12), neck disability Index (NDI), and PPTs at the end of treatment and at one-month follow-up.
RESULTS


Although both groups experienced improvements in pain, neck disability, range of motion, and pressure pain, these only were statistically significant in the VT group. At one-month follow-up, the VT group still showed improvements in pain, neck disability, and range of motion.
DISCUSSION


Vacuum myofascial therapy applied with a device offers similar results to other vacuum-based techniques such as cupping therapy. Moreover, in this device the parameters are digitally controlled, which allows for the precise reproduction of treatment.",2020,"Although both groups experienced improvements in pain, neck disability, range of motion, and pressure pain, these only were statistically significant in the VT group.","['non-specific neck pain', 'thirty-eight participants with non-specific neck pain (NP', 'patients with non-specific neck pain']","['vacuum myofascial therapy device while the PTP group (n\u202f=\u202f19) received five sessions of massage, ultrasound therapy (US), and transcutaneous electric nerve stimulation (TENS', 'Vacuum myofascial therapy device', 'experimental (VT) or a comparison physical therapy program (PTP', 'vacuum myofascial therapy device (VT', 'Vacuum myofascial therapy']","['pain, neck disability, range of motion, and pressure pain', 'numerical pain rating scale (NPRS), range of motion, quality of life (SF-12), neck disability Index (NDI), and PPTs at the end of treatment and at one-month follow-up', 'pressure pain thresholds (PPTs), range of motion (ROM), neck pain-related disability, pain, and quality of life', 'pain, neck disability, and range of motion']","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",38.0,0.0414854,"Although both groups experienced improvements in pain, neck disability, range of motion, and pressure pain, these only were statistically significant in the VT group.","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Rodríguez-Huguet', 'Affiliation': 'Department of Nursing and Physical Therapy. University of Cádiz. Avenida Ana de Viya, 52. 11009, Cádiz, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rodríguez-Huguet', 'Affiliation': 'Department of Traumatology and Orthopedic Surgery. Jerez de la Frontera Hospital. Ronda de Circunvalación. 11407, Jerez de la Frontera, Cádiz, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Lomas-Vega', 'Affiliation': 'Department of Health Sciences, University of Jaén, Paraje Las Lagunillas s/n. 23071, Jaén, Spain.'}, {'ForeName': 'Alfonso Javier', 'Initials': 'AJ', 'LastName': 'Ibáñez-Vera', 'Affiliation': 'Department of Health Sciences, University of Jaén, Paraje Las Lagunillas s/n. 23071, Jaén, Spain. Electronic address: ajibanez@ujaen.es.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodríguez-Almagro', 'Affiliation': 'Department of Health Sciences, University of Jaén, Paraje Las Lagunillas s/n. 23071, Jaén, Spain.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102449']
2364,32951715,The effect of melatonin on treatment of patients with non-alcoholic fatty liver disease: a randomized double blind clinical trial.,"OBJECTIVES


Many factors implicated in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) are including oxidative stress, insulin resistance and abnormal production of adipokines. The aim of this clinical trial was to evaluate the effect of melatonin supplement on some important biochemical markers and signs related to NAFLD.
DESIGN


A randomized double-blind, placebo-controlled, clinical trial.
SETTING


Twenty-four participants in the melatonin group and 21 participants in the placebo group completed the study.
INTERVENTION


Participants received 6 mg melatonin or placebo daily, 1 h before bedtime. The intervention period was 12 weeks.
MAIN OUTCOME MEASURES


Anthropometric measurements, systolic and diastolic blood pressure, liver enzymes, high sensitive C‑reactive protein (hs-CRP), fatty liver grade, also leptin and adiponectin serum levels, were measured at the baseline and the end of intervention.
RESULTS


A significant improvement was observed in weight (p = 0.043), waist circumference (p = 0.027), abdominal circumference (p = 0.043), systolic (p = 0.039), and diastolic (p = 0.015) blood pressure, leptin serum levels (p = 0.032), hs-CRP (p = 0.024), alanine aminotransferase (p = 0.011), aspartate aminotransferase (p = 0.034), also the grade of fatty liver (p = 0.020) in melatonin treated group compared with the placebo.
CONCLUSIONS


Administration of 6 mg/day melatonin had improvement effect on many factors related to NAFLD such as liver enzymes, hs-CRP, anthropometric measurements, blood pressure, leptin serum levels and the grade of fatty liver.",2020,"A significant improvement was observed in weight (p = 0.043), waist circumference (p = 0.027), abdominal circumference (p = 0.043), systolic (p = 0.039), and diastolic (p = 0.015) blood pressure, leptin serum levels (p = 0.032), hs-CRP (p = 0.024), alanine aminotransferase (p = 0.011), aspartate aminotransferase (p = 0.034), also the grade of fatty liver (p = 0.020) in melatonin treated group compared with the placebo.
","['Twenty-four participants in the melatonin group and 21 participants in the placebo group completed the study', 'patients with non-alcoholic fatty liver disease']","['melatonin', 'placebo', 'melatonin supplement', 'melatonin or placebo']","['weight', 'abdominal circumference', 'Anthropometric measurements, systolic and diastolic blood pressure, liver enzymes, high sensitive C‑reactive protein (hs-CRP), fatty liver grade, also leptin and adiponectin serum levels', 'blood pressure, leptin serum levels', 'aspartate aminotransferase', 'systolic', 'grade of fatty liver', 'alanine aminotransferase', 'waist circumference', 'diastolic', 'NAFLD such as liver enzymes, hs-CRP, anthropometric measurements, blood pressure, leptin serum levels and the grade of fatty liver', 'hs-CRP']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]",24.0,0.668331,"A significant improvement was observed in weight (p = 0.043), waist circumference (p = 0.027), abdominal circumference (p = 0.043), systolic (p = 0.039), and diastolic (p = 0.015) blood pressure, leptin serum levels (p = 0.032), hs-CRP (p = 0.024), alanine aminotransferase (p = 0.011), aspartate aminotransferase (p = 0.034), also the grade of fatty liver (p = 0.020) in melatonin treated group compared with the placebo.
","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Bahrami', 'Affiliation': 'Hyperlipidemia Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Makan', 'Initials': 'M', 'LastName': 'Cheraghpour', 'Affiliation': 'Cancer Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jafarirad', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Nutrition Department, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: Jafarirad-s@ajums.ac.ir.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Research Institute for Infectious Disease of Digestive System, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Asadi', 'Affiliation': 'Department of Radiology, School of Medicine, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Hyperlipidemia Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Yari', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102452']
2365,32951720,A Pragmatic Controlled Trial of a Brief Yoga and Mindfulness-Based Program for Psychological and Occupational Health in Education Professionals.,"OBJECTIVES


To examine changes in psychological and occupational wellbeing in education professionals that attended a brief yoga and mindfulness-based program.
DESIGN


Pragmatic controlled trial comparing education professionals that attended a yoga mindfulness-based program (n = 9) to a waitlist control group (n = 22).
SETTING


The 3-day program was delivered at the Kripalu Center for Yoga & Health in Massachusetts.
INTERVENTION


The 3-day yoga mindfulness program included 5 hours per day of yoga, mindfulness exercises, formal meditation, didactic, and experiential activities.
MAIN OUTCOME MEASURES


Measures of psychological and occupational wellbeing were completed before (baseline), immediately after (post-program), and two months after the program (follow-up).
RESULTS


Relative to controls (n = 21), the RISE group (n = 9) showed significant improvements in positive affect (p = .033), negative affect (p = .044), mindfulness (p = .001), empowerment (p = .022), self-compassion (p = .001), and work engagement from baseline to post-program. From baseline to follow-up, the RISE group showed significant improvements in stress (p = .008), negative affect (p = .013), mindfulness (p = .001), empowerment (p = .007), and self-compassion (p = .001) compared to the control group.
CONCLUSIONS


The yoga mindfulness program was associated with improvements in educators' psychological and occupational wellbeing immediately following and 2-months following the program. Future research with a larger sample size is needed to confirm these results.",2020,The yoga mindfulness program was associated with improvements in educators' psychological and occupational wellbeing immediately following and 2-months following the program.,['Education Professionals'],"['Brief Yoga and Mindfulness-Based Program', 'yoga mindfulness-based program (n\u2009=\u20099) to a waitlist control group (n\u2009=\u200922', 'yoga mindfulness program', '3-day yoga mindfulness program included 5\u2009hours per day of yoga, mindfulness exercises, formal meditation, didactic, and experiential activities']","['stress', ""educators' psychological and occupational wellbeing"", 'psychological and occupational wellbeing', 'self-compassion']","[{'cui': 'C0013647', 'cui_str': 'Professional Education'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1442467', 'cui_str': '5 hours'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",,0.0139262,The yoga mindfulness program was associated with improvements in educators' psychological and occupational wellbeing immediately following and 2-months following the program.,"[{'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Dyer', 'Affiliation': 'Kripalu Center for Yoga & Health, 57 Interlaken Rd, Stockbridge, MA, 01262, USA. Electronic address: natalieleighdyer@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Borden', 'Affiliation': 'Kripalu Center for Yoga & Health, 57 Interlaken Rd, Stockbridge, MA, 01262, USA.'}, {'ForeName': 'Jeffery A', 'Initials': 'JA', 'LastName': 'Dusek', 'Affiliation': 'Kripalu Center for Yoga & Health, 57 Interlaken Rd, Stockbridge, MA, 01262, USA.'}, {'ForeName': 'Sat Bir S', 'Initials': 'SBS', 'LastName': 'Khalsa', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA, 02115, USA.""}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102470']
2366,32951725,"Effects of the laying on of hands on anxiety, stress and autonomic response of employees in a hospital: A double-blind randomized controlled trial.","Mental and behavioral disorders result in increased absenteeism and abandonment of work. The objective of this study was to evaluate the anxiety, stress, depression, negative and positive affects, and hematological and autonomic responses of employees in a public hospital exposed to laying on of hands with (LHS) or without Spiritual connection (control-LHW).
METHODOLOGY


Eighty-four employees with anxiety/stress were enrolled and randomly allocated into two groups of intervention LHS by Spiritist ""passe"" and control-LHW by volunteers with healing intent. Anxiety, stress and depression were evaluated by Depression Anxiety and Stress Scale (DASS21). Negative and positive affects by Subjective Well-being Scale (SWS), cardiac autonomic modulation by heart rate variability and cytokines and blood count were assessed by blood sample.
RESULTS


Our study showed a significant improvement in the neutrophils (p = 0.041; d = 0.70) and cardiac parasympathetic activity, and reduction in VLF (p < 0.005) in the LHS. There was reduction in erythrocyte parameters and interleukin 10 (p < 0.005) in the control-LHW. In both groups there was a significant reduction in anxiety, stress, depression and negative affects after one session (p < 0.005).
CONCLUSION


Laying on of hands with Spiritual connection by Spiritist ""passe"" appears to be effective in increasing cardiac vagal activity and regulation of immune responses of employees in a public hospital with stress/anxiety.",2020,There was reduction in erythrocyte parameters and interleukin 10 (p < 0.005) in the control-LHW.,"['Eighty-four employees with anxiety/stress', 'employees in a hospital', 'employees in a public hospital exposed to laying on of hands with (LHS) or without Spiritual connection (control-LHW']","['laying', 'intervention LHS by Spiritist ""passe"" and control-LHW by volunteers with healing intent']","['neutrophils', 'Anxiety, stress and depression', 'anxiety, stress, depression and negative affects', 'cardiac parasympathetic activity, and reduction in VLF', 'Subjective Well-being Scale (SWS), cardiac autonomic modulation by heart rate variability and cytokines and blood count', 'anxiety, stress, depression, negative and positive affects, and hematological and autonomic responses', 'erythrocyte parameters', 'Depression Anxiety and Stress Scale (DASS21', 'anxiety, stress and autonomic response']","[{'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0969660', 'cui_str': 'Laying-on-of-Hands'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0969660', 'cui_str': 'Laying-on-of-Hands'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}]",84.0,0.0184514,There was reduction in erythrocyte parameters and interleukin 10 (p < 0.005) in the control-LHW.,"[{'ForeName': 'Élida Mara', 'Initials': 'ÉM', 'LastName': 'Carneiro', 'Affiliation': 'Integrative and Complementary Practices Center - NUPIC, Clinics Hospital, Uberaba, MG, Brazil; Federal University of Triângulo Mineiro, Uberaba, MG, Brazil; Medical Spiritist Association of Uberaba (AMEUBE), Uberaba, MG, Brazil. Electronic address: elidamc16@gmail.com.'}, {'ForeName': 'Livia Figueira Avezum', 'Initials': 'LFA', 'LastName': 'Oliveira', 'Affiliation': 'Integrative and Complementary Practices Center - NUPIC, Clinics Hospital, Uberaba, MG, Brazil; Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Djalma Alexandre Alves', 'Initials': 'DAA', 'LastName': 'da Silva', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Jéssica Beatriz Ferreira', 'Initials': 'JBF', 'LastName': 'Sousa', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Rodolfo Pessato', 'Initials': 'RP', 'LastName': 'Timóteo', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Octávio Barbosa', 'Initials': 'OB', 'LastName': 'Neto', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Adriana de Paula', 'Initials': 'AP', 'LastName': 'Silva', 'Affiliation': 'Integrative and Complementary Practices Center - NUPIC, Clinics Hospital, Uberaba, MG, Brazil; Federal University of Triângulo Mineiro, Uberaba, MG, Brazil; Medical Spiritist Association of Uberaba (AMEUBE), Uberaba, MG, Brazil.'}, {'ForeName': 'Virmondes', 'Initials': 'V', 'LastName': 'Rodrigues Junior', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Luiz Antônio Pertili Rodrigues', 'Initials': 'LAPR', 'LastName': 'de Resende', 'Affiliation': 'Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Maria de Fátima', 'Initials': 'MF', 'LastName': 'Borges', 'Affiliation': 'Integrative and Complementary Practices Center - NUPIC, Clinics Hospital, Uberaba, MG, Brazil; Federal University of Triângulo Mineiro, Uberaba, MG, Brazil; Medical Spiritist Association of Uberaba (AMEUBE), Uberaba, MG, Brazil.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102475']
2367,32959670,Evaluation of a Resiliency Focused Health Coaching Intervention for Middle School Students: Building Resilience for Healthy Kids Program.,"INTRODUCTION


Youth mental health issues are a growing public health concern. Resilience has been identified as a mitigating factor for adverse mental health outcomes. Schools have shown an increasing interest in strategies to support students' mental health. The purpose of this study was to evaluate a school-based 1:1 health coaching program designed to build resilience by teaching students coping skills and strategies to increase their self-efficacy.
STUDY DESIGN


Single group intervention study with pre/post measures.
SETTING/PARTICIPANTS


Sixth grade students (aged 11-12 years) attending an urban middle school.
INTERVENTION


Youth participated in up to 6 resiliency-focused, 1:1 health coaching sessions completed over 8 weeks and conducted during the school day. Health coaches utilized motivational interviewing techniques to set and work toward resilience-related goals focused on improving coping skills and self-efficacy with youth during the intervention (January through March 2020).
MAIN OUTCOME MEASURES


The Child and Youth Resilience Measure-Revised and other mental health assessments were completed at baseline and immediately following completion of the intervention to evaluate outcomes. Paired sample t-tests and Hedges'  g  effect sizes were conducted to evaluate intervention effectiveness. Student participation rates were assessed throughout the intervention.
RESULTS


287 youth participated in the study (87% participation rate) and participated in over 85% of health coaching sessions offered. A paired samples t-test revealed the youth resilience significantly increased from pre ( M  = 75.7,  SD  = 6.9) to post ( M  = 77.6,  SD  = 6.8) intervention ( t [257] = 3.73,  p  < .001) and the size of the effect was medium ( g  = 0.29, 95% CI = 0.11, 0.46).
CONCLUSIONS


The findings demonstrate that health coaching can be an effective strategy for improving resiliency in youth. Future studies evaluating how to effectively disseminate this intervention strategy are planned.",2020,287 youth participated in the study (87% participation rate) and participated in over 85% of health coaching sessions offered.,"['Sixth grade students (aged 11-12 years) attending an urban middle school', 'Healthy Kids Program', 'Middle School Students', '287 youth participated in the study (87% participation rate) and participated in over 85% of health coaching sessions offered']","['Resiliency Focused Health Coaching Intervention', 'Youth participated in up to 6 resiliency-focused, 1:1 health coaching sessions', 'health coaching', 'school-based 1:1 health coaching program']","['Student participation rates', 'Child and Youth Resilience Measure-Revised and other mental health assessments', 'youth resilience']","[{'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2720502', 'cui_str': 'Mental health assessment'}]",287.0,0.0365812,287 youth participated in the study (87% participation rate) and participated in over 85% of health coaching sessions offered.,"[{'ForeName': 'Joey A', 'Initials': 'JA', 'LastName': 'Lee', 'Affiliation': 'Department of Health Sciences, 14676University of Colorado Colorado Springs, Colorado Springs, CO, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Heberlein', 'Affiliation': ""2932Children's Hospital Colorado, Colorado Springs, CO, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pyle', 'Affiliation': ""2932Children's Hospital Colorado, Colorado Springs, CO, USA.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Caughlan', 'Affiliation': ""2932Children's Hospital Colorado, Colorado Springs, CO, USA.""}, {'ForeName': 'Darvi', 'Initials': 'D', 'LastName': 'Rahaman', 'Affiliation': ""2932Children's Hospital Colorado, Colorado Springs, CO, USA.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Sabin', 'Affiliation': ""2932Children's Hospital Colorado, Colorado Springs, CO, USA.""}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Kaar', 'Affiliation': ""2932Children's Hospital Colorado, Colorado Springs, CO, USA.""}]",American journal of health promotion : AJHP,['10.1177/0890117120959152']
2368,32959761,Waterless Hand Cleansing with Chlorhexidine during the Neonatal Period by Mothers and Other Household Members: Findings from a Randomized Controlled Trial.,"Observational data suggest maternal handwashing with soap prevents neonatal mortality. We tested the impact of a chlorhexidine-based waterless hand cleansing promotion on the behavior of mothers and other household members. In rural Bangladesh in 2014, we randomized consenting pregnant women to chlorhexidine provision and hand cleansing promotion or standard practices. We compared hand cleansing with chlorhexidine or handwashing with soap before baby care, among mothers and household members in the two groups, and measured chlorhexidine use in the intervention arm. Chlorhexidine was observed in the baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes. Hand cleansing before baby care was observed 5.6 times more frequently among mothers in the intervention arm than in the controls (95% CI = 4.0-7.7). Hand cleansing was significantly more frequently observed in the intervention arm among women other than the mother (RR = 10.9) and girls (RR = 37.0). Men and boys in the intervention arm cleansed hands before 29% and 44% of baby care events, respectively, compared with 0% in the control arm. The median number of grams consumed during the neonatal period was 176 (IQR = 95-305 g), about 7.8 g/day (IQR = 4.2-13.8 g). Promotion of waterless chlorhexidine increased hand cleansing behavior among mothers and other household members. Discrepancy between observed use and measured chlorhexidine consumption suggested courtesy bias in structured observations. A waterless hand cleanser may represent one component of the multimodal strategies to prevent neonatal infections in low-resource settings.",2020,"Chlorhexidine was observed in the baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes.","['Mothers and Other Household Members', 'mothers and other household members', ""baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes""]","['chlorhexidine', 'Chlorhexidine', 'chlorhexidine provision and hand cleansing promotion or standard practices', 'chlorhexidine-based waterless hand cleansing promotion']","['hand cleansing behavior', 'median number of grams consumed during the neonatal period', 'Hand cleansing', 'neonatal mortality']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}]",,0.0768261,"Chlorhexidine was observed in the baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes.","[{'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Begum', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Crabtree-Ide', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Mohammad Rofi', 'Initials': 'MR', 'LastName': 'Uddin', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Weaver', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Md Golam', 'Initials': 'MG', 'LastName': 'Dostogir Harun', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Jelena V', 'Initials': 'JV', 'LastName': 'Allen', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Sharifa', 'Initials': 'S', 'LastName': 'Nasreen', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Shams', 'Initials': 'S', 'LastName': 'El Arifeen', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0773']
2369,32959786,Mobile-Enhanced Prevention Support Study for Men Who Have Sex With Men and Transgender Women Leaving Jail: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Men who have sex with men (MSM) and transgender women, particularly those who have experienced criminal justice involvement, have particularly high HIV burdens, and a majority of those in jail have substance use disorders (SUDs). MSM and transgender women also experience elevated rates of incarceration. Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use. Further, the impact experienced by one's social and sexual networks experienced at the time of detention and release have important health implications for MSM and transgender women.
OBJECTIVE


The purpose of this study is to test a new intervention-Mobile-Enhanced Prevention Support (MEPS)-that involves a GPS-based mobile app called GeoPassport (referred to as GeoPass in practice), incentives, and peer support for promoting HIV prevention, substance use treatment, and use of related services.
METHODS


A two-arm, unblinded, randomized controlled trial will seek to enroll 300 HIV-negative MSM and transgender women, aged 18-49 years, with SUDs, who are either in jail or have recently left jail. Participants will be enrolled by study staff and randomized to the MEPS intervention group or usual care group. The intervention group will receive customized wellness goals in addition to GeoPass, cash incentives, and the support of a trained peer mentor for 6 months. Data collection will consist of a baseline survey and three follow-up surveys at 3, 6, and 9 months postenrollment, either in person or by phone or videoconference when necessary. The primary outcomes include establishing a primary care provider; being prescribed and adhering to pre-exposure prophylaxis (PrEP) for HIV; screening for HIV, STIs, and hepatitis C virus; and engagement in recommended treatment for SUDs. Secondary outcomes include obtaining treatment for any identified infections and avoiding recidivism.
RESULTS


Enrollment began in November 2019 and study completion is expected in 2023.
CONCLUSIONS


This study will advance our knowledge base on patient navigation and peer mentor interventions. Peer navigation services have been studied for the treatment of HIV, but less often in the context of HIV and STI prevention among sexual and gender minority populations at the time of re-entry into the community from jail. The MEPS study will examine the acceptability and feasibility of combining peer mentor services with a mobile app to facilitate service utilization and participant-peer mentor communication. MEPS will assess patterns of PrEP uptake and utilization in MSM and transgender women leaving jail. The study will provide heretofore unavailable data from persons leaving jail regarding HIV PrEP, STI screening, substance abuse treatment, and service utilization patterns and experiences, including geocoded data for those in the intervention arm.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT04036396); https://www.clinicaltrials.gov/ct2/show/NCT04036396.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/18106.",2020,"Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use.","['Men', 'Men who have sex with men (MSM) and transgender women, particularly those who have experienced criminal justice involvement, have particularly high HIV burdens, and a majority of those in jail have substance use disorders (SUDs', '300 HIV-negative MSM and transgender women, aged 18-49 years, with SUDs, who are either in jail or have recently left jail', 'With Men and Transgender Women Leaving Jail']","['customized wellness goals in addition to GeoPass, cash incentives, and the support of a trained peer mentor for 6 months', 'MEPS', 'new intervention-Mobile-Enhanced Prevention Support (MEPS)-that involves a GPS-based mobile app called GeoPassport', 'Peer navigation services', 'MEPS intervention group or usual care group']","['obtaining treatment for any identified infections and avoiding recidivism', 'establishing a primary care provider; being prescribed and adhering to pre-exposure prophylaxis (PrEP) for HIV; screening for HIV, STIs, and hepatitis C virus; and engagement in recommended treatment for SUDs']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086072', 'cui_str': 'Criminal Justice'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]",,0.129595,"Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use.","[{'ForeName': 'Gabriel G', 'Initials': 'GG', 'LastName': 'Edwards', 'Affiliation': 'Department of General Internal Medicine and Health Services Research, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Reback', 'Affiliation': 'Center for HIV Identification, Prevention, and Treatment Services, University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Cunningham', 'Affiliation': 'Department of General Internal Medicine and Health Services Research, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Hilliard', 'Affiliation': 'Los Angeles Centers for Alcohol and Drug Abuse, Los Angeles, CA, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McWells', 'Affiliation': 'Los Angeles Centers for Alcohol and Drug Abuse, Los Angeles, CA, United States.'}, {'ForeName': 'Sukrit', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Preventative and Social Medicine, Charles R Drew University, Los Angeles, CA, United States.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Weiss', 'Affiliation': 'Center for HIV Identification, Prevention, and Treatment Services, University of California, Los Angeles, Los Angeles, CA, United States.'}, {'ForeName': 'Nina T', 'Initials': 'NT', 'LastName': 'Harawa', 'Affiliation': 'Department of General Internal Medicine and Health Services Research, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, United States.'}]",JMIR research protocols,['10.2196/18106']
2370,32959898,"The effect of a behavioural management tool in adults with mild to moderate periodontitis. A single-blind, randomized controlled trial.","OBJECTIVE


To compare a behavioural management program (test) to a standard communication approach (control) to reduce plaque, improve clinical outcomes and patient's compliance with oral self-care.
BACKGROUND


Since psychological factors affect oral health-related behaviours, approaches directed at changing behaviours and improving compliance might improve the effect of oral health education.
MATERIALS AND METHODS


This was a randomized, single-blind, parallel-design trial involving 71 patients with mild to moderate periodontitis. During a run-in period, all participants began using a power toothbrush. Two sessions of non-surgical periodontal therapy were performed post-baseline, along with one of the two oral healthcare communication approaches. Plaque and bleeding scores, probing pocket depth (PPD) and clinical attachment level (CAL) were recorded at the screening visit, baseline visit and at 8 and 14 weeks post-baseline. Patients were asked to fill in oral self-care diaries. Experience questionnaires were administered to both clinicians and patients to assess subjective experience of the clinician-patient interactions during the visits.
RESULTS


In both groups, a significant reduction in plaque and bleeding scores was observed from baseline to 8 weeks after baseline, which then remained stable at week 14, but no differences between the groups were noted. An improvement in CAL and PPD was recorded at week 8 post-baseline in the test compared to the control group. No inter-group differences in the clinician's and subject's experience questionnaires were observed.
CONCLUSION


Both approaches significantly promoted periodontal health. However, changing lifestyle requires repeated communication/engagement over time and a behavioural management program based upon two visits did not provide additional benefit compared to a standard approach.",2020,An improvement in CAL and PPD was recorded at week 8 post-baseline in the test compared to the control group.,"['71 patients with mild to moderate periodontitis', 'adults with mild to moderate periodontitis']","['behavioural management tool', 'behavioural management program (test) to a standard communication approach (control']","['plaque and bleeding scores', 'periodontal health', ""clinician's and subject's experience questionnaires"", 'CAL and PPD', 'Plaque and bleeding scores, probing pocket depth (PPD) and clinical attachment level (CAL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",71.0,0.113953,An improvement in CAL and PPD was recorded at week 8 post-baseline in the test compared to the control group.,"[{'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Donos', 'Affiliation': 'Centre for Oral Immunobiology & Regenerative Medicine and Centre for Oral Clinical Research, Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jeanie E', 'Initials': 'JE', 'LastName': 'Suvan', 'Affiliation': 'Unit of Periodontology, Eastman Dental Institute, University College London (UCL), London, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Calciolari', 'Affiliation': 'Centre for Oral Immunobiology & Regenerative Medicine and Centre for Oral Clinical Research, Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Nibali', 'Affiliation': 'Centre for Oral Immunobiology & Regenerative Medicine and Centre for Oral Clinical Research, Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rollnick', 'Affiliation': 'Cochrane School of Primary Care & Public Health, Cardiff University, Cardiff, UK.'}]",Journal of periodontal research,['10.1111/jre.12790']
2371,32960160,Effects of Combined Training With Linear Periodization and Non-Periodization on Sleep Quality of Adults With Obesity.,"Background : Combined exercise training has proven effective in preventing and treating sleep disorders among obese adults. However, structured progression of intensity in sleep parameters remains poorly investigated within this population.  Purpose : To verify the effects of non-periodized and linear periodization combined training on the sleep quality of obese adults.  Methods : This was a randomized controlled trial involving adults with body mass index ≥ 30 kg/m2, allocated to 3 groups: control (CG;  n  = 13), non-periodized training (NG;  n  = 9), and with linear periodization (PG;  n  = 13). Groups PG and NG trained for 16 weeks in 3 weekly sessions lasting of 60 minutes. The NG trained in 50-59% heart rate reserve (HRR) e 2 × 10-12 repetition maximum (RM) and the PG with progression in 3 mesocycles: 40-49%;50-59%; 60-69% HRR e 2x12-14; 2x10-12; 2 × 8-10 RM, with the total volume equated. Sleep quality was evaluated by the Pittsburgh Sleep Quality Index. For statistics, we used Generalized Estimation Equations considering p ≤ 0.05.  Results : Sleep latency was reduced in both training groups after intervention (NG-Δ = -25.56 minutes  p  = .028; PG-Δ = -22.23 minutes  p  = .035), while significant improvements in sleep efficiency were found only in the NG (Δ = 20.67%;  p  = .042).  Conclusion : Despite the NG's apparent superiority, which model has the best sleep effects on obese adults cannot be stated. Hence, caution is needed while extrapolating the results.",2020,Sleep latency was reduced in both training groups after intervention (NG-Δ = -25.56 minutes  p  = .028; PG-Δ = ,"['Adults With Obesity', 'adults with body mass index', 'obese adults']","['control (CG;  n  =\xa013), non-periodized training', 'non-periodized and linear periodization combined training', 'exercise training', 'Combined Training With Linear Periodization and Non-Periodization']","['Sleep latency', 'sleep efficiency', 'Pittsburgh Sleep Quality Index', 'heart rate reserve (HRR', 'sleep quality', 'Sleep quality', 'Sleep Quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.055576,Sleep latency was reduced in both training groups after intervention (NG-Δ = -25.56 minutes  p  = .028; PG-Δ = ,"[{'ForeName': 'Larissa Dos Santos', 'Initials': 'LDS', 'LastName': 'Leonel', 'Affiliation': 'Federal University of Santa Catarina.'}, {'ForeName': 'Willen Remon', 'Initials': 'WR', 'LastName': 'Tozetto', 'Affiliation': 'Federal University of Santa Catarina.'}, {'ForeName': 'Rodrigo Sudatti', 'Initials': 'RS', 'LastName': 'Delevatti', 'Affiliation': 'Federal University of Santa Catarina.'}, {'ForeName': 'Giovani Firpo', 'Initials': 'GF', 'LastName': 'Del Duca', 'Affiliation': 'Federal University of Santa Catarina.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1817294']
2372,32960175,"Effectiveness of a Web-Based SUpport PRogram (SUPR) for Hearing Aid Users Aged 50+: Two-Arm, Cluster Randomized Controlled Trial.","BACKGROUND


Hearing aid (HA) use is known to improve health outcomes for people with hearing loss. Despite that, HA use is suboptimal, and communication issues and hearing-related activity limitations and participation restrictions often remain. Web-based self-management communication programs may support people with hearing loss to effectively self-manage the impact of hearing loss in their daily lives.
OBJECTIVE


The goal of the research is to examine the short- and long-term effects of a web-based self-management SUpport PRogram (SUPR) on communication strategy use (primary outcome) and a range of secondary outcomes for HA users aged 50 years and older.
METHODS


Clients of 36 HA dispensing practices were randomized to SUPR (SUPR recipients; n=180 HA users) and 34 to care as usual (controls; n=163 HA users). SUPR recipients received a practical support booklet and online materials delivered via email over the course of their 6-month HA rehabilitation trajectory. They were encouraged to appoint a communication partner and were offered optional email contact with the HA dispensing practice. The online materials included 3 instruction videos on HA handling, 5 videos on communication strategies, and 3 testimonial videos. Care as usual included a HA fitting rehabilitation trajectory only. Measurements were carried out at baseline, immediately postintervention, 6 months postintervention, and 12 months postintervention. The primary outcome measure was self-reported use of communication strategies (3 subscales of the Communication Profile for the Hearing Impaired [CPHI]). Secondary outcome measures included self-reported personal adjustment to hearing loss (CPHI); use, satisfaction and benefit of HAs and SUPR (use questionnaire; International Outcome Inventory for Hearing Aids [IOI-HA], Alternative Interventions [IOI-AI]); recommendation of HA dispensing services; self-efficacy for HA handling (Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids [MARS-HA]); readiness to act on hearing loss (University of Rhode Island Change Assessment adapted for hearing loss [URICA-HL]); and hearing disability (Amsterdam Inventory for Auditory Disability and Handicap [AIADH]).
RESULTS


Linear mixed model analyses (intention to treat) showed no significant differences between the SUPR and control group in the course of communication strategy use (CPHI). Immediately postintervention, SUPR recipients showed significantly higher self-efficacy for advanced HA handling than the controls, which was sustained at 12 months (MARS-HA; mean difference immediately postintervention: 5.3, 95% CI 0.3 to 10.4; P=.04). Also, SUPR recipients showed significantly greater HA satisfaction than controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.09 to 0.5; P=.006), which was sustained at 12 months, and significantly greater HA use than the controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.02 to 0.5; P=.03), which was not sustained at 12 months.
CONCLUSIONS


This study provides ground to recommend adding SUPR to standard HA dispensing care, as long-term, modest improvements in HA outcomes were observed. Further research is needed to evaluate what adjustments to SUPR are needed to establish long-term effectiveness on outcomes in the psychosocial domain.
TRIAL REGISTRATION


ISRCTN77340339; http://www.isrctn.com/ISRCTN77340339.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1136/bmjopen-2016-015012.",2020,"Immediately postintervention, SUPR recipients showed significantly higher self-efficacy for advanced HA handling than the controls, which was sustained at 12 months (MARS-HA; mean difference immediately postintervention: 5.3, 95% CI 0.3 to 10.4; P=.04).","['people with hearing loss', 'SUPR recipients', 'Hearing Aid', 'HA users aged 50 years and older', 'Clients of 36 HA dispensing practices were randomized to SUPR (SUPR recipients; n=180 HA users) and 34 to care as usual (controls; n=163 HA users', 'Users Aged 50', 'Hearing Aids']","['Web-Based SUpport PRogram (SUPR', 'instruction videos on HA handling, 5 videos on communication strategies, and 3 testimonial videos', 'web-based self-management SUpport PRogram (SUPR', 'Hearing aid (HA']","['HA satisfaction', 'self-reported use of communication strategies (3 subscales of the Communication Profile for the Hearing Impaired [CPHI', 'HA outcomes', 'self-reported personal adjustment to hearing loss (CPHI); use, satisfaction and benefit of HAs and SUPR (use questionnaire; International Outcome Inventory for Hearing Aids', 'self-efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0919808', 'cui_str': 'Hearing aid user'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]","[{'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1384666', 'cui_str': 'Hearing loss'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.135359,"Immediately postintervention, SUPR recipients showed significantly higher self-efficacy for advanced HA handling than the controls, which was sustained at 12 months (MARS-HA; mean difference immediately postintervention: 5.3, 95% CI 0.3 to 10.4; P=.04).","[{'ForeName': 'Janine Fj', 'Initials': 'JF', 'LastName': 'Meijerink', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Ear and Hearing, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Pronk', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Ear and Hearing, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Birgit I', 'Initials': 'BI', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Jansen', 'Affiliation': 'Schoonenberg HoorSupport, Dordrecht, Netherlands.'}, {'ForeName': 'Sophia E', 'Initials': 'SE', 'LastName': 'Kramer', 'Affiliation': 'Otolaryngology-Head and Neck Surgery, Ear and Hearing, Amsterdam Public Health research institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}]",Journal of medical Internet research,['10.2196/17927']
2373,32960178,Understanding the Steps Toward Mobile Early Intervention for Mothers and Their Infants Exiting the Neonatal Intensive Care Unit: Descriptive Examination.,"BACKGROUND


Neonatal intensive care unit (NICU) history, combined with systemic inequities for mothers of nondominant cultures and mothers who are socioeconomically disadvantaged, places infants at an extraordinary risk for poor developmental outcomes throughout life. Although receipt of early intervention (EI) is the best single predictor of developmental outcomes among children with and at risk for early developmental delays, mothers and infants with the greatest needs are least likely to receive EI. Mobile internet-based interventions afford substantial advantages for overcoming logistical challenges that often prevent mothers who are economically disadvantaged from accessing EI. However, the bridge from the NICU to a mobile internet intervention has been virtually unexplored.
OBJECTIVE


This study aims to examine progression flow from NICU exit referral to an early mobile internet intervention to increase EI access and promote parent mediation of infant social-emotional and communication development.
METHODS


Three NICUs serving the urban poor in a Midwestern city were provided support in establishing an electronic NICU exit referral mechanism into a randomized controlled trial of a mobile internet intervention for mothers and their infants. Measurement domains to reflect the bridge to service included each crucial gateway required for navigating the path into Part C EI, including referral, screening, assessment, and intervention access. An iterative process was used and documented to facilitate each NICU in establishing an individualized accountability plan for sharing referral materials with mothers before their NICU exit. Subsequent to the referral, progression flow was documented on the basis of a real-time electronic recording of service receipt and contact records. Mother and infant risk characteristics were also assessed. Descriptive analyses were conducted to summarize and characterize each measurement domain.
RESULTS


NICU referral rates for EI were 3 to 4 times higher for open-shared versus closed-single gatekeeper referral processes. Of 86 referred dyads, 67 (78%) were screened, and of those screened, 51 (76%) were eligible for assessment. Of the 51 assessment-eligible mothers and infants, 35 dyads (69%) completed the assessment and 31 (89%) went on to complete at least one remote coaching intervention session. The dyads who accessed and engaged in intervention were racially and ethnically diverse and experiencing substantial adversity.
CONCLUSIONS


The transition from the NICU to home was fraught with missed opportunities for an EI referral. Beyond the referral, the most prominent reason for not participating in screening was that mothers could not be located after exiting the NICU. Stronger NICU referral mechanisms for EI are needed. It may be essential to initiate mobile interventions before exiting the NICU for maintaining post-NICU contact with some mothers. In contrast to a closed, single point of referral gatekeeper systems in NICUs, open, shared referral gating systems may be less stymied by individual service provider biases and disruptions.",2020,"RESULTS


NICU referral rates for EI were 3 to 4 times higher for open-shared versus closed-single gatekeeper referral processes.","['51 assessment-eligible mothers and infants, 35 dyads (69%) completed the assessment and 31 (89%) went on to complete at least one remote coaching intervention session', 'Three NICUs serving the urban poor in a Midwestern city', 'mothers who are economically disadvantaged from accessing EI', 'Of 86 referred dyads, 67 (78%) were screened, and of those screened, 51 (76%) were eligible for assessment', 'for mothers and their infants']","['Mobile internet-based interventions', 'mobile internet intervention']",[],"[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]",[],51.0,0.0587987,"RESULTS


NICU referral rates for EI were 3 to 4 times higher for open-shared versus closed-single gatekeeper referral processes.","[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Baggett', 'Affiliation': 'Mark Chaffin Center for Healthy Development, School of Public Health, Georgia State Universtiy, Atlanta, GA, United States.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': 'Oregon Research Institute, Eugene, OR, United States.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Landry', 'Affiliation': 'University of Texas Health Sciences Center- Houston, Houston, TX, United States.'}, {'ForeName': 'Edward G', 'Initials': 'EG', 'LastName': 'Feil', 'Affiliation': 'Oregon Research Institute, Eugene, OR, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Whaley', 'Affiliation': 'University of Kansas, Kansas City, KS, United States.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Schnitz', 'Affiliation': ""Juniper Gardens Children's Project, University of Kansas, Kansas City, KS, United States.""}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Leve', 'Affiliation': 'Oregon Research Institute, Eugene, OR, United States.'}]",Journal of medical Internet research,['10.2196/18519']
2374,32960179,"Digital Cardiovascular Biomarker Responses to Transcutaneous Cervical Vagus Nerve Stimulation: State-Space Modeling, Prediction, and Simulation.","BACKGROUND


Transcutaneous cervical vagus nerve stimulation (tcVNS) is a promising alternative to implantable stimulation of the vagus nerve. With demonstrated potential in myriad applications, ranging from systemic inflammation reduction to traumatic stress attenuation, closed-loop tcVNS during periods of risk could improve treatment efficacy and reduce ineffective delivery. However, achieving this requires a deeper understanding of biomarker changes over time.
OBJECTIVE


The aim of the present study was to reveal the dynamics of relevant cardiovascular biomarkers, extracted from wearable sensing modalities, in response to tcVNS.
METHODS


Twenty-four human subjects were recruited for a randomized double-blind clinical trial, for whom electrocardiography and photoplethysmography were used to measure heart rate and photoplethysmogram amplitude responses to tcVNS, respectively. Modeling these responses in state-space, we (1) compared the biomarkers in terms of their predictability and active vs sham differentiation, (2) studied the latency between stimulation onset and measurable effects, and (3) visualized the true and model-simulated biomarker responses to tcVNS.
RESULTS


The models accurately predicted future heart rate and photoplethysmogram amplitude values with root mean square errors of approximately one-fifth the standard deviations of the data. Moreover, (1) the photoplethysmogram amplitude showed superior predictability (P=.03) and active vs sham separation compared to heart rate; (2) a consistent delay of greater than 5 seconds was found between tcVNS onset and cardiovascular effects; and (3) dynamic characteristics differentiated responses to tcVNS from the sham stimulation.
CONCLUSIONS


This work furthers the state of the art by modeling pertinent biomarker responses to tcVNS. Through subsequent analysis, we discovered three key findings with implications related to (1) wearable sensing devices for bioelectronic medicine, (2) the dominant mechanism of action for tcVNS-induced effects on cardiovascular physiology, and (3) the existence of dynamic biomarker signatures that can be leveraged when titrating therapy in closed loop.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02992899; https://clinicaltrials.gov/ct2/show/NCT02992899.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1016/j.brs.2019.08.002.",2020,The models accurately predicted future heart rate and photoplethysmogram amplitude values with root mean square errors of approximately one-fifth the standard deviations of the data.,['Twenty-four human subjects'],"['electrocardiography and photoplethysmography', 'Transcutaneous cervical vagus nerve stimulation (tcVNS']","['heart rate and photoplethysmogram amplitude responses', 'superior predictability']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]",24.0,0.288599,The models accurately predicted future heart rate and photoplethysmogram amplitude values with root mean square errors of approximately one-fifth the standard deviations of the data.,"[{'ForeName': 'Asim H', 'Initials': 'AH', 'LastName': 'Gazi', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, United States.'}, {'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, United States.'}, {'ForeName': 'Kristine L S', 'Initials': 'KLS', 'LastName': 'Richardson', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, United States.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, United States.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA, United States.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Atlanta, GA, United States.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, United States.'}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': 'School of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, United States.'}]",JMIR mHealth and uHealth,['10.2196/20488']
2375,32960242,Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery: A Randomized Clinical Trial.,"Importance


Obesity increases the risk of both cesarean delivery and surgical-site infection. Despite widespread use, it is unclear whether prophylactic negative pressure wound therapy reduces surgical-site infection after cesarean delivery in obese women.
Objective


To evaluate whether prophylactic negative pressure wound therapy, initiated immediately after cesarean delivery, lowers the risk of surgical-site infections compared with standard wound dressing in obese women.
Design, Setting, and Participants


Multicenter randomized trial conducted from February 8, 2017, through November 13, 2019, at 4 academic and 2 community hospitals across the United States. Obese women undergoing planned or unplanned cesarean delivery were eligible. The study was terminated after 1624 of 2850 participants were recruited when a planned interim analysis showed increased adverse events in the negative pressure group and futility for the primary outcome. Final follow-up was December 18, 2019.
Interventions


Participants were randomly assigned to either undergo prophylactic negative pressure wound therapy, with application of the negative pressure device immediately after repair of the surgical incision (n = 816), or receive standard wound dressing (n = 808).
Main Outcomes and Measures


The primary outcome was superficial or deep surgical-site infection according to the Centers for Disease Control and Prevention definitions. Secondary outcomes included other wound complications, composite of surgical-site infections and other wound complications, and adverse skin reactions.
Results


Of the 1624 women randomized (mean age, 30.4 years, mean body mass index, 39.5), 1608 (99%) completed the study: 806 in the negative pressure group (median duration of negative pressure, 4 days) and 802 in the standard dressing group. Superficial or deep surgical-site infection was diagnosed in 29 participants (3.6%) in the negative pressure group and 27 (3.4%) in the standard dressing group (difference, 0.36%; 95% CI, -1.46% to 2.19%, P = .70). Of 30 prespecified secondary end points, 25 showed no significant differences, including other wound complications (2.6% vs 3.1%; difference, -0.53%; 95% CI, -1.93% to 0.88%; P = .46) and composite of surgical-site infections and other wound complications (6.5% vs 6.7%; difference, -0.27%; 95% CI, -2.71% to 2.25%; P = .83). Adverse skin reactions were significantly more frequent in the negative pressure group (7.0% vs 0.6%; difference, 6.95%; 95% CI, 1.86% to 12.03%; P < .001).
Conclusions and Relevance


Among obese women undergoing cesarean delivery, prophylactic negative pressure wound therapy, compared with standard wound dressing, did not significantly reduce the risk of surgical-site infection. These findings do not support routine use of prophylactic negative pressure wound therapy in obese women after cesarean delivery.
Trial Registration


ClinicalTrials.gov Identifier: NCT03009110.",2020,"Superficial or deep surgical-site infection was diagnosed in 29 participants (3.6%) in the negative pressure group and 27 (3.4%) in the standard dressing group (difference, 0.36%; 95% CI, -1.46% to 2.19%, P = .70).","['obese women', 'Obese Women', 'obese women after cesarean delivery', '1624 of 2850 participants', 'Obese women undergoing planned or unplanned cesarean delivery were eligible', '1624 women randomized (mean age, 30.4 years, mean body mass index, 39.5), 1608 (99%) completed the study: 806 in the negative pressure group (median duration of negative pressure, 4 days) and 802 in the standard dressing group', 'February 8, 2017, through November 13, 2019, at 4 academic and 2 community hospitals across the United States', 'obese women undergoing cesarean delivery', 'After Cesarean Delivery']","['Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing', 'standard wound dressing', 'prophylactic negative pressure wound therapy, with application of the negative pressure device immediately after repair of the surgical incision (n\u2009=\u2009816), or receive standard wound dressing', 'prophylactic negative pressure wound therapy']","['wound complications', 'wound complications, composite of surgical-site infections and other wound complications, and adverse skin reactions', 'Adverse skin reactions', 'Superficial or deep surgical-site infection', 'adverse events', 'risk of surgical-site infection', 'superficial or deep surgical-site infection according to the Centers for Disease Control and Prevention definitions', 'Surgical-Site Infection', 'composite of surgical-site infections and other wound complications']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]",2850.0,0.233264,"Superficial or deep surgical-site infection was diagnosed in 29 participants (3.6%) in the negative pressure group and 27 (3.4%) in the standard dressing group (difference, 0.36%; 95% CI, -1.46% to 2.19%, P = .70).","[{'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, Washington University School of Medicine in St Louis, Missouri.'}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Department of Obstetrics and Gynecology, Ochsner Health, New Orleans, Louisiana.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Trudell', 'Affiliation': 'Division of Maternal Fetal Medicine, BJC Medical Group St Louis, Missouri.'}, {'ForeName': 'Ebony B', 'Initials': 'EB', 'LastName': 'Carter', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Shanks', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Woolfolk', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Aaron B', 'Initials': 'AB', 'LastName': 'Caughey', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Warren', 'Affiliation': 'Department of Medicine, Washington University School of Medicine in St Louis, Missouri.'}, {'ForeName': 'Anthony O', 'Initials': 'AO', 'LastName': 'Odibo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of South Florida School of Medicine, Tampa.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Colditz', 'Affiliation': 'Department of Surgery, Washington University School of Medicine in St Louis, Missouri.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Department of Obstetrics and Gynecology, Dell School of Medicine, University of Texas at Austin.'}, {'ForeName': 'Lorie', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham.'}]",JAMA,['10.1001/jama.2020.13361']
2376,32960456,Introduction of a Management Toolkit for Lewy Body Dementia: A Pilot Cluster-Randomized Trial.,"BACKGROUND


Lewy body dementia, comprising both dementia with Lewy bodies and Parkinson's disease dementia, is challenging to manage because of a complex symptom profile and lack of clear evidence-based management guidelines.
OBJECTIVES


We assessed the feasibility of undertaking a cluster randomized study of the introduction of an evidence-based management toolkit for Lewy body dementia, assessing the outcomes for patients and carers as secondary measures.
METHODS


We randomized 23 memory/dementia, movement disorder, or nonspecialist secondary care services to the management toolkit or usual care. People with dementia with Lewy bodies or Parkinson's disease dementia underwent assessments of cognition, motor and neuropsychiatric symptoms, and global outcome at baseline and 3 and 6 months. Healthcare, personal and social care costs, and carer-related outcomes of carer stress, depression, and anxiety were also examined.
RESULTS


A total of 131 participants were recruited (target 120), for whom 6-month data were available on 108 (83%). There was a benefit of being in the intervention arm for carers (reduced Zarit Burden Scale [P < 0.01], reduced depressive symptoms [P < 0.05]), who also reported less marked patient deterioration on the global outcome measure (P < 0.05). There were no significant differences in other outcomes or in costs between groups.
CONCLUSIONS


The introduction of an evidence-based management toolkit for Lewy body dementia was feasible and associated with some benefits, especially for carers. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC. on behalf of International Parkinson and Movement Disorder Society.",2020,"There was a benefit of being in the intervention arm for carers (reduced Zarit Burden Scale [P < 0.01], reduced depressive symptoms [P < 0.05]), who also reported less marked patient deterioration on the global outcome measure (P < 0.05).","['2020', 'Lewy Body Dementia', ""People with dementia with Lewy bodies or Parkinson's disease dementia"", 'A total of 131 participants were recruited (target 120), for whom 6-month data were available on 108 (83']",[],"['Healthcare, personal and social care costs, and carer-related outcomes of carer stress, depression, and anxiety', 'reduced depressive symptoms']","[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4517530', 'cui_str': '108'}]",[],"[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",131.0,0.08697,"There was a benefit of being in the intervention arm for carers (reduced Zarit Burden Scale [P < 0.01], reduced depressive symptoms [P < 0.05]), who also reported less marked patient deterioration on the global outcome measure (P < 0.05).","[{'ForeName': 'John T', 'Initials': 'JT', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'McKeith', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Thomas', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bamford', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hill', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Allan', 'Affiliation': 'Institute of Health Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Finch', 'Affiliation': 'Department of Nursing, Midwifery and Health, Faculty of Health & Life Sciences, Northumbria University, Newcastle, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McNally', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Ajenthan', 'Initials': 'A', 'LastName': 'Surendranathan', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Joseph P M', 'Initials': 'JPM', 'LastName': 'Kane', 'Affiliation': ""Centre for Public Health, Queen's University, Belfast, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dunn', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Bentley', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Barker', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burn', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, UK.'}, {'ForeName': 'John-Paul', 'Initials': 'JP', 'LastName': 'Taylor', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle, UK.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28282']
2377,32960464,Impact of the Goal-directed Medication review Electronic Decision Support System (G-MEDSS)© on Drug Burden Index: a cluster-randomised clinical trial in primary care.,"AIM


The Goal-directed Medication review Electronic Decision Support System (G-MEDSS) assesses and reports a patient's goals, attitudes to deprescribing and Drug Burden Index (DBI) score, a measure of cumulative exposure to anticholinergic and sedative medications. This study evaluated the effect of implementing G-MEDSS in Home Medicines Reviews (HMRs) on DBI exposure and clinical outcomes.
METHODS


A cluster-randomised clinical trial was performed across Australia. Accredited Clinical Pharmacists were randomised into intervention (G-MEDSS with usual care HMR) or comparison groups (usual care HMR alone). Patients were recruited by pharmacists from those routinely referred by general practitioners for HMR. The primary outcome was the proportion of patients with any reduction in DBI at 3-months follow-up. Secondary outcomes included change in DBI continuous score at 3-months, HMR recommendations to change DBI and clinical outcomes.
RESULTS


There were 201 patient participants at baseline (n=88 intervention, n=113 comparison), with 159 followed-up at 3-months (n=63 intervention, n=96 comparison). The proportion of patients with a reduction in DBI was not significantly different at 3-months (intervention 17%, comparison 11%; adjusted odds ratio (aOR) 1.44, 95%CI 0.56-3.80). Regarding secondary outcomes, there was no difference in change in DBI score at 3-months. However, the HMR report made recommendations to reduce DBI for a significantly greater proportion of patients in the intervention than in the comparison group (intervention 37%, comparison 14%; aOR 3.20, 95%CI 1.50-6.90). No changes were observed in clinical outcomes.
CONCLUSION


Implementation of G-MEDSS within HMR did not reduce patients' DBI at 3-months compared with usual care HMR.",2020,"The proportion of patients with a reduction in DBI was not significantly different at 3-months (intervention 17%, comparison 11%; adjusted odds ratio (aOR)","['Patients were recruited by pharmacists from those routinely referred by general practitioners for HMR', '201 patient participants at baseline (n=88 intervention, n=113 comparison), with 159 followed-up at 3-months (n=63 intervention, n=96 comparison']","['implementing G-MEDSS', 'Goal-directed Medication review Electronic Decision Support System (G-MEDSS', 'intervention (G-MEDSS with usual care HMR) or comparison groups (usual care HMR alone']","['adjusted odds ratio (aOR', 'proportion of patients with any reduction in DBI', 'change in DBI continuous score at 3-months, HMR recommendations to change DBI and clinical outcomes', 'DBI score', 'DBI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0553514', 'cui_str': 'Referral source'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",201.0,0.154378,"The proportion of patients with a reduction in DBI was not significantly different at 3-months (intervention 17%, comparison 11%; adjusted odds ratio (aOR)","[{'ForeName': 'Lisa Kouladjian', 'Initials': 'LK', 'LastName': ""O'Donnell"", 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Danijela', 'Initials': 'D', 'LastName': 'Gnjidic', 'Affiliation': 'Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Mouna', 'Initials': 'M', 'LastName': 'Sawan', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Reeve', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Chen', 'Affiliation': 'Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'J Simon', 'Initials': 'JS', 'LastName': 'Bell', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Sarah N', 'Initials': 'SN', 'LastName': 'Hilmer', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.'}]",British journal of clinical pharmacology,['10.1111/bcp.14557']
2378,32952089,Health insurance literacy: How best to measure and does it matter to health care access and affordability?,"BACKGROUND


Health insurance is complex, cost are continuously rising, and people are assuming more of these costs. Health insurance literacy (HIL) is related to healthcare access, yet there is no agreement about how best to measure HIL.
OBJECTIVES


Contrast two HIL measures. First, evaluating their association with demographic characteristics, insurance type, and health status. Second, comparing how these distinct measures relate to access, forgone care, and financial burden of health care.
METHODS


Data are from a 2017 telephone survey focused on health insurance coverage and access. Participants were randomly assigned either the 4-item likelihood of proactive use scale or a 4-item measure of confidence in use of insurance. Logistic regressions assess correlates of each HIL measure and their association with a range of access measures.
RESULTS


For both measures, 25% of insured adults report high HIL. Few demographic and health status measures are associated with high HIL and they are different for each measure. For both measures, high HIL translates into reports of having a usual source of care and confidence in getting care when needed. The HIL measures behave in opposite ways for forgone care due to costs and problems paying medical bills. Adults scoring high on the likelihood measure are more likely to forgo care and report financial burden. By contrast, adults scoring high on the confidence measure are less likely to forgo care and report burdensome medical bills.
CONCLUSIONS


The two measures capture different concepts and raise the question of whether reporting a likely behavior or being confident of that behavior are predictive when it is time to use health insurance. Because HIL is measured at the same time as the outcomes, we reason that the likelihood measure is capturing peoples' past experience using insurance and may result in more proactive use of insurance in the future.",2020,"By contrast, adults scoring high on the confidence measure are less likely to forgo care and report burdensome medical bills.
","['Health insurance literacy', 'Data are from a 2017 telephone survey focused on health insurance coverage and access']",[],"['access, forgone care, and financial burden of health care']","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0444454', 'cui_str': 'Access'}]",[],"[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.0288406,"By contrast, adults scoring high on the confidence measure are less likely to forgo care and report burdensome medical bills.
","[{'ForeName': 'Kathleen Thiede', 'Initials': 'KT', 'LastName': 'Call', 'Affiliation': 'University of Minnesota, School of Public Health, State Health Access Data Assistance Center 2221 University Avenue, Suite 345, Minneapolis, MN, 55414, United States. Electronic address: callx001@umn.edu.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Conmy', 'Affiliation': 'Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, Room 447D--Hubert H. Humphrey Building 200 Independence Avenue SW, Washington, DC, 20201, United States.'}, {'ForeName': 'Giovann', 'Initials': 'G', 'LastName': 'Alarcón', 'Affiliation': 'University of Minnesota, School of Public Health, State Health Access Data Assistance Center 2221 University Avenue, Suite 345, Minneapolis, MN, 55414, United States.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Hagge', 'Affiliation': 'Minnesota Department of Health, Health Economics Program, Golden Rule Building 85 7th Place E, St Paul, MN, 55101, United States.'}, {'ForeName': 'Alisha Baines', 'Initials': 'AB', 'LastName': 'Simon', 'Affiliation': 'Minnesota Department of Health, Health Economics Program, Golden Rule Building 85 7th Place E, St Paul, MN, 55101, United States.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.09.002']
2379,32952230,Relationship between the polymorphism in the interleukin 1-β and the treatment time of patients subjected to a modified piezocision technique.,"Aim


We aimed to evaluate the correlation between the polymorphism of the interleukin 1-Beta (IL1-β, +3954 C>T) and tooth movement, in a group of Colombian patients undergoing surgically accelerated orthodontic tooth movement.
Methods


The study was nested to a controlled clinical trial. Blood samples were taken from 11 women and 29 healthy Colombian male volunteers between 18 and 40 years old, after 1 year of starting orthodontic treatment. The patients presented malocclusion class I, with grade II or III. To detect the genetic polymorphism of the nucleotide +3954 C to T in the IL-1β gene, we used a real-time PCR assay.
Results


Eleven individuals presented the allele 2 (T) heterozygous with the allele 1 (T/C) and 19 individuals were homozygous for the allele 1 (C/C). When analyzing the presence of the SNP, no significant differences were found in any of the variables. The best treatment was reflected in Group 3 (selective upper and lower alveolar decortication and 3D collagen matrix) and Group 4 (only selective alveolar decortication in the upper arch, with 3D collagen matrix), with 27% and 35% more speed respectively than in the control group.
Conclusions


Our analyses indicated that a reduction in the total treatment time can be mostly potentiated by using decortication and collagen matrices and not for the presence of the allele 2 in the IL-1β. Nevertheless, it is important that further studies investigate if the polymorphism could be associated with the speed of tooth movement and analyze the baseline protein levels.",2020,Our analyses indicated that a reduction in the total treatment time can be mostly potentiated by using decortication and collagen matrices and not for the presence of the allele 2 in the IL-1β.,"['patients presented malocclusion class', '11 women and 29 healthy Colombian male volunteers between 18 and 40 years old, after 1 year of starting orthodontic treatment', 'Colombian patients undergoing surgically accelerated orthodontic tooth movement']",[],['interleukin 1-Beta'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}]",[],"[{'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}]",11.0,0.0374632,Our analyses indicated that a reduction in the total treatment time can be mostly potentiated by using decortication and collagen matrices and not for the presence of the allele 2 in the IL-1β.,"[{'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Aristizábal', 'Affiliation': 'Universidad del Valle, Facultad de Salud, Escuela de Odontología, Departamento de Ortodoncia, Cali. Colombia.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Rios', 'Affiliation': 'University of Michigan, School of Dentistry, Department of Periodontics and Oral Medicine. Michigan, USA.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Rey', 'Affiliation': 'Universidad CES, Facultad de Odontología, Departmento de Ortodoncia. Medellin, Colombia.'}, {'ForeName': 'María Antonia', 'Initials': 'MA', 'LastName': 'Álvarez', 'Affiliation': 'Universidad CES, Facultad de Odontología, Departmento de Ortodoncia. Medellin, Colombia.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Parra', 'Affiliation': 'Universidad del Valle, Facultad de Salud, Escuela de Ciencias Básicas, Departamento de Microbiología. Cali. Colombia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ortiz', 'Affiliation': 'Universidad del Valle, Facultad de Salud, Escuela de Ciencias Básicas, Departamento de Morfología, Cali. Colombia.'}]","Colombia medica (Cali, Colombia)",['10.25100/cm.v51i1.4141']
2380,32952231,"Implementation of a new Single-Pass Whole-Body Computed Tomography Protocol: Is it safe, effective and efficient in patients with severe trauma?","Purpose


The objective of this study was to evaluate the implementation of a new single-pass whole-body computed tomography Protocol in the management of patients with severe trauma.
Methods


This was a descriptive evaluation of polytrauma patients who underwent whole-body computed tomography. Patients were divided into three groups: 1. Blunt trauma hemodynamically stable 2. Blunt trauma hemodynamically unstable and 3. Penetrating trauma. Demographics, whole-body computed tomography parameters and outcome variables were evaluated.
Results


Were included 263 patients. Median injury severity score was 22 (IQR: 16-22). Time between arrival to the emergency department and completing the whole-body computed tomography was under 30 minutes in most patients [Group 1: 28 minutes (IQR: 14-55), Group 2: 29 minutes (IQR: 16-57), and Group 3: 31 minutes (IQR: 13-50;  p = 0.96)]. 172 patients (65.4%) underwent non-operative management. The calculated and the real survival rates did not vary among the groups either [Group 1: TRISS 86.4% vs. real survival rate 85% ( p = 0.69); Group 2: TRISS 69% vs. real survival rate 74% ( p = 0.25); Group 3: TRISS 93% vs. real survival rate 87% ( p = 0.07)].
Conclusion


This new single-pass whole-body computed tomography protocol was safe, effective and efficient to decide whether the patient with severe trauma requires a surgical intervention independently of the mechanism of injury or the hemodynamic stability of the patient. Its use could also potentially reduce the rate of unnecessary surgical interventions of patients with severe trauma including those with penetrating trauma.",2020,"The calculated and the real survival rates did not vary among the groups either [Group 1: TRISS 86.4% vs. real survival rate 85% ( p = 0.69); Group 2: TRISS 69% vs. real survival rate 74% ( p = 0.25); Group 3: TRISS 93% vs. real survival rate 87% ( p = 0.07)].
","['polytrauma patients who underwent whole-body computed tomography', 'patients with severe trauma', 'Blunt trauma hemodynamically unstable and 3', 'Blunt trauma hemodynamically stable 2', '263 patients', 'patients with severe trauma including those with penetrating trauma', '172 patients (65.4%) underwent non-operative management']","['new single-pass whole-body computed tomography Protocol', 'new Single-Pass Whole-Body Computed Tomography Protocol']","['Median injury severity score', 'real survival rate', 'real survival rates']","[{'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0043253', 'cui_str': 'Blunt injury'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0445262', 'cui_str': 'Single pass'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",263.0,0.037571,"The calculated and the real survival rates did not vary among the groups either [Group 1: TRISS 86.4% vs. real survival rate 85% ( p = 0.69); Group 2: TRISS 69% vs. real survival rate 74% ( p = 0.25); Group 3: TRISS 93% vs. real survival rate 87% ( p = 0.07)].
","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ordoñez', 'Affiliation': 'Universidad del Valle, Facultad de Salud, Escuela de Medicina, Sección de Cirugía de Trauma y EmergenciasCali, Colombia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'García', 'Affiliation': 'Fundación Valle del Lili, Radiology Department, Cali, Colombia.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Parra', 'Affiliation': 'Broward General Level I Trauma Center, Department of Trauma Critical Care. Fort Lauderdale, FL. EEUU.'}, {'ForeName': 'Edison', 'Initials': 'E', 'LastName': 'Angamarca', 'Affiliation': 'Universidad del Valle, Facultad de Salud, Escuela de Medicina, Sección de Cirugía de Trauma y EmergenciasCali, Colombia.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Guzmán-Rodríguez', 'Affiliation': 'Fundación Valle del Lili, Centro de Investigaciones Clínicas (CIC), Cali, Colombia.'}, {'ForeName': 'Claudia P', 'Initials': 'CP', 'LastName': 'Orlas', 'Affiliation': ""Harvard Medical School & Harvard T.H. Chan School of Public Health, Brigham & Women's Hospital, Department of Surgery, Center for Surgery and Public Health Boston, MA, EEUU.""}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Herrera-Escobar', 'Affiliation': ""Harvard Medical School & Harvard T.H. Chan School of Public Health, Brigham & Women's Hospital, Department of Surgery, Center for Surgery and Public Health Boston, MA, EEUU.""}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Rincón', 'Affiliation': 'Fundación Valle del Lili, Radiology Department, Cali, Colombia.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Meléndez', 'Affiliation': 'Universidad del Valle, Facultad de Salud, Escuela de Medicina, Sección de Cirugía de Trauma y EmergenciasCali, Colombia.'}, {'ForeName': 'Jose Julián', 'Initials': 'JJ', 'LastName': 'Serna', 'Affiliation': 'Fundación Valle del Lili, Division of Trauma and Acute Care Surgery, Cali, Colombia.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Padilla', 'Affiliation': 'Universidad ICESI, Facultad de Medicina, Cali, Colombia.'}, {'ForeName': 'Ana Milena', 'Initials': 'AM', 'LastName': 'Del Valle', 'Affiliation': 'Universidad del Valle, Facultad de Salud, Escuela de Medicina, Sección de Cirugía de Trauma y EmergenciasCali, Colombia.'}, {'ForeName': 'Alberto F', 'Initials': 'AF', 'LastName': 'García', 'Affiliation': 'Fundación Valle del Lili, Division of Trauma and Acute Care Surgery, Cali, Colombia.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Holguín', 'Affiliation': 'Fundación Valle del Lili, Radiology Department, Cali, Colombia.'}]","Colombia medica (Cali, Colombia)",['10.25100/cm.v51i1.4224']
2381,32952283,Group Cohesion and Climate in Cognitive Behavioral Therapy for Individuals with a First-Time DUI.,"Few studies have examined group cohesion and climate in the substance use disorder treatment literature. We examined whether group cohesion and climate are associated with increased self-efficacy outcomes and reduced drinks per week, binge drinking and DUI behaviors, in a sample of individuals with a first-time DUI receiving either cognitive behavioral therapy (CBT) or usual care. Additionally, we examined whether CBT moderates these relationships. Group measures and drinking outcomes were not significantly associated. This study is the first to provide an in-depth analysis on group processes in DUI settings, and as such, provides important insights into how group processes may differ in a mandated DUI context.",2020,Group measures and drinking outcomes were not significantly associated.,"['individuals with a first-time DUI receiving either', 'Individuals with a First-Time DUI']",['cognitive behavioral therapy (CBT) or usual care'],"['self-efficacy outcomes and reduced drinks per week, binge drinking and DUI behaviors', 'drinking outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.015216,Group measures and drinking outcomes were not significantly associated.,"[{'ForeName': 'Maricela', 'Initials': 'M', 'LastName': 'Cruz', 'Affiliation': 'Department of Statistics, University of California, Irvine.'}, {'ForeName': 'Karen Chan', 'Initials': 'KC', 'LastName': 'Osilla', 'Affiliation': 'RAND Corporation, Santa Monica.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Paddock', 'Affiliation': 'RAND Corporation, Santa Monica.'}]",Alcoholism treatment quarterly,['10.1080/07347324.2019.1613941']
2382,32952428,How Effective are Psychosocial Group Workings in Improving Treatment Compliance and Self-Efficacy? An Experimental Study with Substance Users.,"Introduction


Group work is one of the most effective treatment methods in rehabilitation of substance use behavior. In addition, the individual's motivation to quit substance and self-efficacy perceptions of quitting are important factors for the course of the treatment. Therefore, the aim of this study was to investigate the effect of group work process on motivational processes (intrinsic and extrinsic motivation, interpersonal help seeking and confidence-in-treatment subscales) and self-efficacy perception of substance users.
Method


This is an experimental study with 43 substance users. The Treatment Motivation Questionnaire subscales were used to measure the effect of the group work on the dimensions of treatment motivation (intrinsic motivation, extrinsic motivation, confidence-in-treatment, interpersonal help seeking), and the General Self-Efficacy Scale was used to measure the effect of group work on the self-efficacy perceptions.
Results


The group work resulted in a significant increase in participants' intrinsic motivation and confidence-in-treatment. However, group work did not result in any significant change in extrinsic motivation, interpersonal help seeking and the perception of self-efficacy. In the follow-up process, a significant decrease was observed in the participants' self-efficacy perceptions.
Conclusions


Group work with substance users increases the intrinsic motivation and confidence-in-treatment. Therefore, group work practices will increase the effectiveness of substance use treatment.",2020,"However, group work did not result in any significant change in extrinsic motivation, interpersonal help seeking and the perception of self-efficacy.",['43 substance users'],[],"['Treatment Motivation Questionnaire subscales', 'treatment motivation (intrinsic motivation, extrinsic motivation, confidence-in-treatment, interpersonal help seeking', ""participants' self-efficacy perceptions"", 'intrinsic motivation and confidence', ""participants' intrinsic motivation and confidence-in-treatment"", 'extrinsic motivation, interpersonal help seeking and the perception of self-efficacy', 'motivational processes (intrinsic and extrinsic motivation, interpersonal help seeking and confidence-in-treatment subscales) and self-efficacy perception']","[{'cui': 'C0338666', 'cui_str': 'Misuses drugs'}]",[],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0392342', 'cui_str': 'Extrinsic motivation'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0205102', 'cui_str': 'Internal'}]",,0.0220674,"However, group work did not result in any significant change in extrinsic motivation, interpersonal help seeking and the perception of self-efficacy.","[{'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Görgülü', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center, Rochester, NY, USA.'}]",Noro psikiyatri arsivi,['10.29399/npa.24810']
2383,32952509,Short-Term Efficacy of Kinesiotaping versus Extracorporeal Shockwave Therapy for Plantar Fasciitis: A Randomized Study.,"Background


Plantar fasciitis is a degenerative condition that is one of the most common causes of heel and foot pain. Among noninvasive management of plantar fasciitis, extracorporeal shockwave therapy (ESWT) has been extensively studied and found to be effective, but few studies have assessed the effectiveness of kinesiotaping (KT) method.
Objective


This study aimed to show the effectiveness of KT compared with ESWT in the management of plantar fasciitis.
Methods


A total of 84 patients with plantar fasciitis were enrolled from a single center and randomized into KT and ESWT treatment groups in a 1:1 ratio (i.e., 42 patients in each group); only one foot was considered for each patient. Both KT and ESWT were applied once a week for 6 weeks. Patients' pain, functional status and quality of life were evaluated with the visual analog scale (VAS), Foot Function Index (FFI) and the Short-Form-36 (SF-36) health survey, respectively. Patients' fat pat and plantar fascia thickness were measured using ultrasonography. All evaluations were performed before and immediately after the 6-week intervention.
Results


In the KT group, six patients were lost to follow-up; therefore, the final analysis only included 36 patients. After the intervention, there was a statistically significant improvement in the VAS and SF-36 scores of both groups ( P  = 0.001), but the FFI score improvement was statistically significant only in the KT group ( P  = 0.001). In both groups, the mean thickness of plantar fascia decreased after treatment and the mean thickness of the fat pat increased; however, the change was not statistically significant ( P  = 0.935 and  P  = 0.832, respectively).
Conclusion


Both KT and ESWT treatments improved pain levels and quality of life in patients with plantar fasciitis, but KT also improved functionality. Multicentered studies with larger sample size and longer follow-ups are required to further validate these findings.",2020,"In both groups, the mean thickness of plantar fascia decreased after treatment and the mean thickness of the fat pat increased; however, the change was not statistically significant ( P  = 0.935 and  P  = 0.832, respectively).
","['patients with plantar fasciitis', 'Plantar Fasciitis', '84 patients with plantar fasciitis']","['extracorporeal shockwave therapy (ESWT', 'Kinesiotaping versus Extracorporeal Shockwave Therapy', 'KT and ESWT', 'ESWT', 'KT']","['FFI score improvement', 'fat pat and plantar fascia thickness', ""Patients' pain, functional status and quality of life"", 'mean thickness of plantar fascia', 'VAS and SF-36 scores', 'visual analog scale (VAS), Foot Function Index (FFI) and the Short-Form-36 (SF-36) health survey', 'pain levels and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",84.0,0.0261023,"In both groups, the mean thickness of plantar fascia decreased after treatment and the mean thickness of the fat pat increased; however, the change was not statistically significant ( P  = 0.935 and  P  = 0.832, respectively).
","[{'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Tezel', 'Affiliation': 'Physical Medicine and Rehabilitation Clinic, Ministry of Health Ankara Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Umay', 'Affiliation': 'Physical Medicine and Rehabilitation Clinic, Ministry of Health Ankara Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Bulut', 'Affiliation': 'Physical Medicine and Rehabilitation Clinic, Ministry of Health Ankara Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Aytul', 'Initials': 'A', 'LastName': 'Cakci', 'Affiliation': 'Physical Medicine and Rehabilitation Clinic, Ministry of Health Ankara Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}]",Saudi journal of medicine & medical sciences,['10.4103/sjmms.sjmms_624_19']
2384,32952511,Role of Glucuronidation Pathway in Quetiapine Metabolism: An  In vivo  Drug-Drug Interaction Study between Quetiapine and Probenecid.,"Background


Uridine 5'-diphospho-glucuronosyltransferase (UGT) enzymes play a significant role in the metabolism of quetiapine, and coadministration with a UGT inhibitor/inducer drug may change its pharmacokinetic profile.
Objective


The objective of this study was to assess the impact of probenecid, a UGT enzyme inhibitor, on the pharmacokinetic profile of quetiapine.
Materials and Methods


Twelve treatment-naïve, 7-week-old male Sprague-Dawley rats (weighting 161 ± 22 g) were randomly and equally divided into control, quetiapine-alone and quetiapine plus probenecid groups. The quetiapine plus probenecid group received a single oral dose of probenecid (50 mg/kg) followed by 50 mg/kg of quetiapine; the quetiapine-alone group only received 50 mg/kg of quetiapine. Blood samples (0.2 ml) were collected from all rats after 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 h of the drug administration in heparinized tubes. The pre-established liquid chromatography-mass spectrometry method was utilized to ascertain the plasma concentration of quetiapine and the control group was used to prepare the controlled standard.
Results


Significant pharmacokinetic differences were observed between the quetiapine-alone and quetiapine plus probenecid groups in terms of C max  (392 ± 209 vs. 1323 ± 343 ug/L, respectively,  P  = 0.004), AUC 0-∞  ( P  = 0.04) and T max  ( P  = 0.004). Further, in the combined drug group, there was a decrease in drug clearance (CL/F) (from 27 ± 11 to 16 ± 3 L/h/kg;  P  = 0.005) and an increase in the volume of distribution (Vd) ( P  = 0.01), but there was no significant difference between both groups in terms of half-lives ( P  = 0.27). No significant within-group variability of pharmacokinetic parameters was observed ( P  = 0.25).
Conclusion


The results of this animal study suggest that glucuronidation by UGT enzyme system may also play an important role in quetiapine metabolism, which, if proven in future human studies, would imply that the bioavailability and pharmacokinetic parameters of quetiapine may require alterations when co-administered with probenecid to avoid development of quetiapine toxicity.",2020,"No significant within-group variability of pharmacokinetic parameters was observed ( P  = 0.25).
","['Materials and Methods\n\n\nTwelve treatment-naïve, 7-week-old male Sprague-Dawley rats (weighting 161 ± 22 g']","['quetiapine-alone group only received 50 mg/kg of quetiapine', 'quetiapine-alone and quetiapine plus probenecid', 'quetiapine plus probenecid', 'quetiapine', 'probenecid', 'Quetiapine and Probenecid']","['volume of distribution (Vd', 'drug clearance (CL/F', 'pharmacokinetic parameters']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034715', 'cui_str': 'Sprague-Dawley rat'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0450404', 'cui_str': '22G'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033209', 'cui_str': 'Probenecid'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C4085663', 'cui_str': 'Drug clearance'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0178131,"No significant within-group variability of pharmacokinetic parameters was observed ( P  = 0.25).
","[{'ForeName': 'Haseeb', 'Initials': 'H', 'LastName': 'Sattar', 'Affiliation': 'Department of Clinical Pharmacy, Wuhan Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Sarmad Sheraz', 'Initials': 'SS', 'LastName': 'Jadoon', 'Affiliation': 'Department of Pharmacology, Hubei University of Traditional Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Pharmacy, Wuhan Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shihong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Pharmacy, Wuhan Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Mingzhen', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Department of Clinical Pharmacy, Wuhan Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Clinical Pharmacy, Wuhan Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Ramzan', 'Affiliation': 'Department of Internal Medicine, Pakistan institute of Medical Sciences Affiliated to Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad, Pakistan.'}, {'ForeName': 'Weiyong', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Pharmacy, Wuhan Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Saudi journal of medicine & medical sciences,['10.4103/sjmms.sjmms_441_19']
2385,32952527,Effects of nicorandil on myocardial infarct size in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: study design and protocol for the randomized controlled trial.,"Previous studies have shown that nicorandil has a protective effect on cardiomyocytes. However, there is no study to investigate whether perioperative intravenous nicorandil can further reduce the myocardial infarct size in patients with ST-segment elevation myocardial infarction (STEMI) compared to the current standard of percutaneous coronary intervention (PCI) regimen. The CHANGE (China-Admini stration of Nicorandil Group) study is a multicenter, prospective, randomized, double-blind and parallel-controlled clinical study of STEMI patients undergoing primary PCI in China, aiming to evaluate the efficacy and safety of intravenous nicorandil in ameliorating the myocar dial infarct size in STEMI patients undergoing primary PCI and provide evidence-based support for myocardial protection strategies of STEMI patients.",2020,"The CHANGE (China-Admini stration of Nicorandil Group) study is a multicenter, prospective, randomized, double-blind and parallel-controlled clinical study of STEMI patients undergoing primary PCI in China, aiming to evaluate the efficacy and safety of intravenous nicorandil in ameliorating the myocar dial infarct size in STEMI patients undergoing primary PCI and provide evidence-based support for myocardial protection strategies of STEMI patients.","['patients with ST-segment elevation myocardial infarction (STEMI', 'patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention', 'STEMI patients undergoing primary PCI in China', 'STEMI patients undergoing primary PCI and provide evidence-based support for myocardial protection strategies of STEMI patients']",['nicorandil'],['myocardial infarct size'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0068700', 'cui_str': 'Nicorandil'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.211693,"The CHANGE (China-Admini stration of Nicorandil Group) study is a multicenter, prospective, randomized, double-blind and parallel-controlled clinical study of STEMI patients undergoing primary PCI in China, aiming to evaluate the efficacy and safety of intravenous nicorandil in ameliorating the myocar dial infarct size in STEMI patients undergoing primary PCI and provide evidence-based support for myocardial protection strategies of STEMI patients.","[{'ForeName': 'Xiao-Si', 'Initials': 'XS', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, the First Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Li-Chao', 'Initials': 'LC', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology, the First Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Zi-Chao', 'Initials': 'ZC', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, the First Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Zou', 'Affiliation': 'Department of Cardiology, the First Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, the First People's Hospital of Yunlin, Guangxi, China.""}, {'ForeName': 'Xin-Chun', 'Initials': 'XC', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Department of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Jin-Wen', 'Initials': 'JW', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology, Hainan Hospital of PLA General Hospital, Hainan, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Affiliated Hospital of Zunyi Medical College, Guizhou, China.'}, {'ForeName': 'Zong-Zhuang', 'Initials': 'ZZ', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Guizhou Provincial People's Hospital, Guizhou, China.""}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, the Second Hospital of Hebei Medical University, Hebei, China.'}, {'ForeName': 'Ren-Qiang', 'Initials': 'RQ', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, the Second Affiliated Hospital of Nanchang University, Jiangxi, China.'}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, the First Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yun-Dai', 'Initials': 'YD', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, the First Medical Center of Chinese PLA General Hospital, Beijing, China.'}]",Journal of geriatric cardiology : JGC,['10.11909/j.issn.1671-5411.2020.08.002']
2386,32955832,Acute high-intensity interval training improves motor skill acquisition.,"BACKGROUND


It is well established that acute exercise improves cognitive function. However, less is known about the effects of exercise on motor skill acquisition. Therefore, this study investigated the effects of acute high-intensity interval training (HIIT) on motor skill acquisition.
METHODS


Sixty individuals (27 males, 33 females) between 18 and 40 years of age participated in two testing sessions separated by one week. During visit 1, participants performed one block of a continuous tracking, force control task to establish baseline ability. Participants were then randomized to either an aerobic-only HIIT group (HIIT-A), an aerobic/resistance HIIT group (HIIT-AR), or a resting control group. Both exercise groups performed a 20-minute, digital versatile disc (DVD)-delivered HIIT exercise protocol during visit 2. Following exercise or rest, all participants performed five blocks of the same force control task to assess skill acquisition.
RESULTS


On visit 2, the HIIT-A group had a significantly lower total performance error (E) compared to the control group (P<0.05). Both exercise groups (HIIT-A and HIIT-AR) had a significantly lower peak amplitude error (PE) following exercise compared to the control group (P<0.05). No significant group differences were observed for temporal error (TE). Additionally, no significant differences were observed between the exercise groups (P>0.05).
CONCLUSIONS


These findings suggest that acute HIIT-A improves motor skill acquisition compared to rest. Furthermore, improvements in acquisition appeared to be a result of improved spatial accuracy. Therefore, performing HIIT-A prior to practicing a motor task may help reduce total error during the motor skill acquisition phase.",2020,Both exercise groups (HIIT-A and HIIT-AR) had a significantly lower peak amplitude error (PE) following exercise compared to the control group (P<0.05).,"['Sixty individuals (27 males, 33 females) between 18 and 40 years of age participated in two testing sessions separated by one week']","['digital versatile disc (DVD)-delivered HIIT exercise protocol', 'aerobic-only HIIT group (HIIT-A), an aerobic/resistance HIIT group (HIIT-AR), or a resting control group', 'acute high-intensity interval training (HIIT']","['motor skill acquisition', 'temporal error (TE', 'cognitive function', 'total performance error (E', 'peak amplitude error (PE']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",60.0,0.0371916,Both exercise groups (HIIT-A and HIIT-AR) had a significantly lower peak amplitude error (PE) following exercise compared to the control group (P<0.05).,"[{'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Kendall', 'Affiliation': 'Department of Kinesiology, Taylor University, Upland, CA, USA - brad_kendall@taylor.edu.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Siekirk', 'Affiliation': 'Division of Kinesiology, Health and Sport Studies, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lai', 'Affiliation': 'Division of Kinesiology, Health and Sport Studies, Wayne State University, Detroit, MI, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10580-2']
2387,32955836,Dynamics of ventilation parameters at different load intensities and the options to influence it by a breathing exercise.,"BACKGROUND


Minimizing the energy required for breathing muscles is based on the adaptation of the respiratory muscles which is reflected in the reduction of breathing frequency (BF) and tidal volume (V<inf>T</inf>) increase. This may be influenced through a targeted BE and the quality of breathing may be linked to endurance performance. Aim of this study was assess dynamic ventilation parameters at different load intensities and their changes due to the systematic breathing exercise (BE).
METHODS


Study recruit 36 runners of both sexes with a mean age 16.8±1.6 years. A random distribution was performed. The intervention program consisted of a set of BE aimed at the activation of the diaphragm. We monitored the dynamics of ventilation parameters at intensities 2, 3, 4 W/kg during a stepped test on a bicycle ergometer.
RESULTS


The BE was focused on the activation of the diaphragm for a 12.2±3.6 minutes per day, sixteen weeks. After eight weeks, there were significant changes in V<inf>T</inf> and BF (P<0.05). After sixteen weeks there was a significant increase in V<inf>T</inf> of 5.7-18.3% (P<0.01), depending on the load level, BF values decreased significantly by 5.4-14.4% (P<0.01). V<inf>E</inf> and VO<inf>2</inf> values were without changes. There were no significant changes in the control group.
CONCLUSIONS


It was confirmed that the two-month BE intervention focused on the activation of the diaphragm is sufficient and resulted in a significant change in the values of dynamic ventilation parameters. After four months of intervention, the changes are significantly greater compared with values found after a two-month intervention period.",2020,V<inf>E</inf> and VO<inf>2</inf> values were without changes.,['Study recruit 36 runners of both sexes with a mean age 16.8±1.6 years'],['systematic breathing exercise (BE'],"['dynamic ventilation parameters', 'breathing frequency (BF) and tidal volume', 'load level, BF values']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",36.0,0.0160417,V<inf>E</inf> and VO<inf>2</inf> values were without changes.,"[{'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Bahenský', 'Affiliation': 'Department of Sports Science, Faculty of Education, University of South Bohemia, České Budějovice, Czech Republic - pbahensky@pf.jcu.cz.'}, {'ForeName': 'Václav', 'Initials': 'V', 'LastName': 'Bunc', 'Affiliation': 'Sports Motor Skills Laboratory, Faculty of Sports, Physical Training and Education, Charles University, Prague, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Marko', 'Affiliation': 'Department of Sports Science, Faculty of Education, University of South Bohemia, České Budějovice, Czech Republic.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Malátová', 'Affiliation': 'Department of Sports Science, Faculty of Education, University of South Bohemia, České Budějovice, Czech Republic.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10793-X']
2388,32955839,Effects of pelvic and core strength training on biomechanical risk factors for anterior cruciate ligament injuries.,"BACKGROUND


Little is known about the changes in biomechanical risk factors for an anterior cruciate ligament (ACL) injury after participation in a pelvic and core strength training (PCST) program in female team players.
METHODS


This is a randomized controlled trial for which a total of 29 female soccer players were recruited from a soccer club and split into two groups, namely, experimental group (EG, N.=18; mean [SD] age, 17.8 [2.0 years], weight 64.0 [6.6] kg and height 1.7 [0.0] m) and control group (control, N.=11; mean [SD] age, 16.2 [1.2] years, weight 61.6 [7.3] kg and height 1.7 [0.0] m). The EG participated in an in-season 8-week PCST program (twice/week). Participants in the CG performed their normal training without additional pelvic and core strengthening. Pre- and postintervention knee frontal plane projection angle (FPPA), hip, knee and ankle peak flexion angles and jump height were collected during bilateral and unilateral drop jumps.
RESULTS


PCST significantly reduced FPPA at dynamic landing, in both dominant (-7.1º) and non-dominant lower extremities (-8º). Further, this training significantly increased the peak hip (24.4º) and knee flexion angles (14.94º), but not the peak ankle dorsiflexion angle (P>0.05) which, significantly decreased in the CG (-3.5º). Following the intervention, EG significantly increased measures obtained for both bilateral (2.84 cm) and unilateral jumps (1.33 cm for the dominant leg and 1.22 cm for the non-dominant leg) (P<0.05), not so for CG (P<0.05).
CONCLUSIONS


PCST resulted in improvements on ACL injury risk factors and vertical drop jump performance, suggesting that strengthening this body part warrants not only injury prevention, but increases jumping performance.",2020,"Following the intervention, EG significantly increased measures obtained for both bilateral (2.84 cm) and unilateral jumps (1.33 cm for the dominant leg and 1.22 cm for the non-dominant leg) (P<0.05), not so for CG (P<0.05).
","['anterior cruciate ligament injuries', '29 female soccer players were recruited from a soccer club and split into two groups, namely, experimental group (EG, N.=18; mean [SD] age, 17.8 [2.0 years], weight 64.0 [6.6] kg and height 1.7 [0.0] m) and control group (control, N.=11; mean [SD] age, 16.2 [1.2] years, weight 61.6 [7.3] kg and height 1.7 [0.0] m', 'anterior cruciate ligament (ACL) injury after participation in a pelvic and', 'female team players']","['PCST', 'normal training without additional pelvic and core strengthening', 'pelvic and core strength training', 'core strength training (PCST) program']","['FPPA at dynamic landing', 'peak hip (24.4º) and knee flexion angles', 'peak ankle dorsiflexion angle', 'ACL injury risk factors and vertical drop jump performance', 'biomechanical risk factors', 'unilateral jumps', 'Pre- and postintervention knee frontal plane projection angle (FPPA), hip, knee and ankle peak flexion angles and jump height']","[{'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",29.0,0.014644,"Following the intervention, EG significantly increased measures obtained for both bilateral (2.84 cm) and unilateral jumps (1.33 cm for the dominant leg and 1.22 cm for the non-dominant leg) (P<0.05), not so for CG (P<0.05).
","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ferri-Caruana', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Science of Physical Activity and Sport, University of Valencia, Valencia, Spain - ana.maria.ferri@uv.es.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Prades-Insa', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Science of Physical Activity and Sport, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Serra-AÑÓ', 'Affiliation': 'UBIC Research Group, Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Valencia, Spain.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10552-8']
2389,32955841,The effects of a 6-month moderate-intensity Hatha yoga-based training program on health-related fitness in middle-aged sedentary women: a randomized controlled study.,"BACKGROUND


There is paucity of data examining the effectiveness of long-term Hatha yoga-based (HY) programs focused on the health-related fitness (H-RF) of asymptomatic, sedentary women. The purpose of this study was to examine the effects of a 6-month HY-based training program on H-RF components in sedentary middle-aged women.
METHODS


Eighty sedentary women were randomly assigned into either the HY group (HYG) (N.=42) or the control group (CG) (N.=38). The 6-month HYG program involved a progressive series of Vinyasa Flow poses performed 3 times/week for 60 minutes (40 minutes within the exercise zone of 60-75% HR<inf>max</inf>). The CG participants did not undergo any physical training or education. Health-related fitness parameters included measures of pre- and post-training: body composition, muscular strength and maximal voluntary isometric torques of elbow flexors and knee extensors, cardio-respiratory fitness, lower back and hamstring flexibility and a static-dynamic balance.
RESULTS


Two-way mixed design ANOVA revealed significant main effects for all the indicators of H-RF. Tukey post-hoc tests confirmed that the HYG demonstrated significant improvements in every variable tested. Examples of the benefits achieved include (all P<.001): an average loss of 1.03 kg and a 4.82% decrease in body fat, 14.6% and 13.1% gains in isometric strength of the knee extensors and elbow flexors respectively, an increase in relative VO<inf>2max</inf> of 6.1% (33.12±5.30 to 35.14±4.82 mL/kg/min), a 4-cm or 10.4% increase in their MSAR, and an average improved Balance Index of 5.6 mm/s. Reversely, the CG showed non-significant changes in H-RF variables (all P>0.05; percent range from -1.4% to 1.1%).
CONCLUSIONS


By participating in a moderate-intensity 6-month HY-based training program, middle-aged women can significantly improve their HR-F status. The application of progressive target heart rate goals facilitated greater than expected improvements in cardio-respiratory fitness and improvements in body composition.",2020,The application of progressive target heart rate goals facilitated greater than expected improvements in cardio-respiratory fitness and improvements in body composition.,"['middle-aged sedentary women', 'sedentary middle-aged women', 'Eighty sedentary women', 'By participating in a moderate-intensity 6-month HY-based training program, middle-aged women']","['moderate-intensity Hatha yoga-based training program', '6-month HY-based training program', 'control group (CG']","['cardio-respiratory fitness and improvements in body composition', 'HR-F status', 'Balance Index', 'body fat', 'composition, muscular strength and maximal voluntary isometric torques of elbow flexors and knee extensors, cardio-respiratory fitness, lower back and hamstring flexibility and a static-dynamic balance', 'isometric strength of the knee extensors and elbow flexors', 'health-related fitness', 'H-RF variables']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0230102', 'cui_str': 'Lower back structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",80.0,0.0265605,The application of progressive target heart rate goals facilitated greater than expected improvements in cardio-respiratory fitness and improvements in body composition.,"[{'ForeName': 'Michał T', 'Initials': 'MT', 'LastName': 'Boraczyński', 'Affiliation': 'Department of Health Sciences, Olsztyn University, Olsztyn, Poland - michal.boraczynski@gmail.com.'}, {'ForeName': 'Tomasz W', 'Initials': 'TW', 'LastName': 'Boraczyński', 'Affiliation': 'Department of Health Sciences, Olsztyn University, Olsztyn, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Wójcik', 'Affiliation': 'Department of Environmental Sciences, University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gajewski', 'Affiliation': 'Department of Physical Education, Józef Piłsudski University of Physical Education in Warsaw, Warsaw, Poland.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Laskin', 'Affiliation': 'School of Physical Therapy and Rehabilitation Sciences, University of Montana, Missoula, MT, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10549-8']
2390,32956255,Suicide Risk Management Protocol for a Randomized Controlled Trial of Cardiac Patients Reporting Hopelessness.,"BACKGROUND


Investigators conducting studies that include potentially suicidal individuals are obligated to develop a suicide risk management (SRM) protocol. There is little available in the literature to guide researchers in SRM protocol development.
OBJECTIVES


To describe an SRM protocol developed for a randomized controlled trial (RCT) currently enrolling cardiac patients who report moderate to severe levels of hopelessness.
METHODS


The SRM protocol identifies suicidal ideation and measures ideation severity through use of the Columbia-Suicide Severity Rating Scale (C-SSRS) risk factor questions. Based on responses, study participants are deemed safe or at low, moderate, or high risk for suicide. The SRM protocol guides research staff through a plan of action based on risk level. The protocol further guides staff through a plan over the course of this prospective study-from hospital enrollment to home-based visits.
RESULTS


Research staff are well-trained to identify suicidal ideation risk factors, initiate specific questioning about suicidal intent, determine level of risk, identify protective factors and a safe environment, and make referrals if needed. Of the 51 patients hospitalized with cardiac disease who reported moderate to severe hopelessness, 43 scored at a safe suicide risk level and eight scored at low risk. Thirty-five of the 51 patients enrolled in the RCT. Of the 35 participants who received home visits to date, there have been three instances of low and one instance of moderate suicide risk. The SRM protocol has been consistently and accurately used by research personnel in both hospital and home settings. One modification has been made to the protocol since study activation, namely the addition of an assessment of counseling history and encouragement of continued counseling. Booster training sessions of research staff will continue throughout the course of the RCT.
DISCUSSION


Use of the SRM protocol identifies study participants who are safe or at risk for suicide in both hospital and home settings, and research staff can refer participants accordingly.
CONCLUSION


The SRM protocol developed for this RCT can serve as a model in the development of SRM protocols for future research in acute care, community, or home-based settings.",2020,The SRM protocol identifies suicidal ideation and measures ideation severity through use of the Columbia-Suicide Severity Rating Scale (C-SSRS) risk factor questions.,"['51 patients hospitalized with cardiac disease who reported moderate to severe hopelessness, 43 scored at a safe suicide risk level and eight scored at low risk', 'enrolling cardiac patients who report moderate to severe levels of hopelessness', 'Cardiac Patients Reporting Hopelessness', '35 participants who received home visits', 'Thirty-five of the 51 patients enrolled in the RCT']",[],['suicidal ideation and measures ideation severity through use of the Columbia-Suicide Severity Rating Scale (C-SSRS) risk factor questions'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]",51.0,0.0394905,The SRM protocol identifies suicidal ideation and measures ideation severity through use of the Columbia-Suicide Severity Rating Scale (C-SSRS) risk factor questions.,"[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Dunn', 'Affiliation': 'University of Illinois at Chicago College of Nursing, Chicago, IL.'}, {'ForeName': 'Holli A', 'Initials': 'HA', 'LastName': 'DeVon', 'Affiliation': 'University of California Los Angeles School of Nursing, Los Angeles, CA.'}, {'ForeName': 'Eileen G', 'Initials': 'EG', 'LastName': 'Collins', 'Affiliation': 'University of Illinois at Chicago College of Nursing, Chicago, IL.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Luong', 'Affiliation': 'University of Illinois at Chicago College of Nursing, Chicago, IL.'}, {'ForeName': 'Madison P', 'Initials': 'MP', 'LastName': 'Buursma', 'Affiliation': 'University of Illinois at Chicago College of Nursing, Chicago, IL.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gutierrez-Kapheim', 'Affiliation': 'University of Illinois at Chicago College of Nursing, Chicago, IL.'}, {'ForeName': 'Ulf G', 'Initials': 'UG', 'LastName': 'Bronas', 'Affiliation': 'University of Illinois at Chicago College of Nursing, Chicago, IL.'}]",Nursing research,['10.1097/NNR.0000000000000474']
2391,32956262,"Effects of Short-Term Unilateral Strength Training on Measures of Postural Control When Wearing ""Operationally Relevant"" Backpack Loads.","Krajewski, KT, Bansbach, HM, McLean, L, McKenzie, C, Rawcliffe, A, Graham, SM, Flanagan, SD, Pourmoghaddam, A, Dettmer, M, and Connaboy, C. Effects of short-term unilateral strength training on measures of postural control when wearing ""operationally relevant"" backpack loads. J Strength Cond Res 34(10): 2743-2750, 2020-To examine the effects of ""operationally relevant"" loads on postural stability and to determine the effects of unilateral and bilateral strength training programs on postural stability in healthy, recruit-aged men. Fifteen subjects were randomly assigned to either a unilateral (UL; n = 7) or bilateral (BL; n = 8) strength training group, which performed strength training 3 times a week for 4 weeks. Subjects completed the following pretest and post-test assessments: 1 repetition maximum in bilateral (1RM-BL) and unilateral (1RM-UL) stance positions and bilateral and unilateral balance tasks with eyes open and eyes closed. Balance tasks were performed over 3 loading conditions: body mass (BM), 50% BM, and 70% BM. Sample entropy (SE) and root mean square (RMS) were calculated from the center of pressures collected during each balance assessment. The UL strength training group showed significant improvement after training in both 1RM-UL (p < 0.01) and 1RM-BL (p < 0.01). The BL strength training group only showed significant improvement in 1RM-BL (p = 0.01). There was a significant main effect of load on RMS (p < 0.05) across all balance tasks with RMS increasing with increasing load. Sample entropy was found to decrease with increasing load in the unilateral eyes open and bilateral stance tasks. Significant increases in strength (∼10 to -29%) were observed; however, increased strength alone is not enough to mitigate the effects of load carriage on the postural control, even when training is performed in stance positions that are posturally challenging. Therefore, ""operationally relevant"" loads negatively impact postural stability in novice load carriers when assessing nonlinear measures.",2020,The UL strength training group showed significant improvement after training in both 1RM-UL (p < 0.01) and 1RM-BL (p < 0.01).,"['healthy, recruit-aged men', 'J Strength Cond Res 34(10', 'Fifteen subjects']","['unilateral and bilateral strength training programs', 'BL strength training', 'Short-Term Unilateral Strength Training', 'repetition maximum in bilateral (1RM-BL) and unilateral (1RM-UL) stance positions and bilateral and unilateral balance tasks with eyes open and eyes closed', 'unilateral (UL; n = 7) or bilateral (BL; n = 8) strength training group, which performed strength training']","['Measures of Postural Control', 'bilateral stance tasks', 'Krajewski, KT, Bansbach, HM, McLean, L, McKenzie, C, Rawcliffe, A, Graham, SM, Flanagan, SD, Pourmoghaddam, A, Dettmer, M, and Connaboy, C. Effects', 'strength', 'Sample entropy (SE) and root mean square (RMS', '1RM-BL', 'postural stability']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0138427,The UL strength training group showed significant improvement after training in both 1RM-UL (p < 0.01) and 1RM-BL (p < 0.01).,"[{'ForeName': 'Kellen T', 'Initials': 'KT', 'LastName': 'Krajewski', 'Affiliation': 'Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bansbach', 'Affiliation': 'Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'McLean', 'Affiliation': 'Edinburgh Napier University, Edinburgh, Scotland, United Kingdom.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Edinburgh Napier University, Edinburgh, Scotland, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rawcliffe', 'Affiliation': 'Department of Occupational Medicine, HQ ARITC, UK Ministry of Defence, United Kingdom.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Graham', 'Affiliation': 'Edinburgh Napier University, Edinburgh, Scotland, United Kingdom.'}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'Flanagan', 'Affiliation': 'Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Pourmoghaddam', 'Affiliation': 'Memorial Bone & Joint Research Foundation, Houston, Texas.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Dettmer', 'Affiliation': 'Memorial Bone & Joint Research Foundation, Houston, Texas.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Connaboy', 'Affiliation': 'Department of Sports Medicine and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003794']
2392,32956264,Mud Pack With Menthol and Arnica Montana Accelerates Recovery Following a High-Volume Resistance Training Session for Lower Body in Trained Men.,"Bartolomei, S, Nigro, F, D'Amico, A, Cortesi, M, and Di Michele, R. Mud pack with menthol and Arnica montana accelerates recovery following a high-volume resistance training session for lower body in trained men. J Strength Cond Res XX(X): 000-000, 2020-The aim of this study was to compare the effects of a mud pack, containing menthol and Arnica montana, on the recovery responses following a high-volume resistance protocol. Ten resistance-trained men (mean ± SD: age = 25.3 ± 6.1 years; body mass = 79.1 ± 10.6 kg; height = 178.9 ± 7.5 cm) performed a high-volume resistance workout for lower body squat and leg extension, (5 sets of 10 reps at 70% of one repetition maximum for both exercises). All the subject used mud (MUD) or a placebo (PL) in randomized counterbalanced crossover design. MUD or PL were applied 4 times: 3, 19, 27, and 45 hours after the workout, on the skin surface above the quadriceps muscle of both legs. Muscle performance (countermovement jump power [CMJP], isokinetic leg press at 75 cm·s and 25 cm·s [ISOK75 and ISOK25, respectively], isometric squat [ISQ]), and morphology (muscle thickness of vastus lateralis [VLMT]), were measured before exercise (baseline [BL]), and 15 minutes (15P), 24 hours (24P), and 48 hours (48P) postexercise. In addition, muscle soreness was assessed at the same time points using a visual analog scale (VAS). No significant interactions (p > 0.05) between the trials were detected for CMJP, ISOK75, ISQ, and VLMT. A significant interaction between trials was noted for ISOK25 (p = 0.022) and for VAS (p = 0.001). ISOK25 was significantly (p < 0.01) reduced from BL at 15P, 24P and 48P in PL, whereas changes were significant (p < 0.05) at 15P and 24P only in MUD. The present findings indicate that MUD may enhance the recovery rate of strength and reduce muscle soreness after high-volume exercise. Muscle morphology do not seem to be influenced by mud packs.",2020,A significant interaction between trials was noted for ISOK25,"['Trained Men', 'Ten resistance-trained men (mean ± SD: age = 25.3 ± 6.1 years; body mass = 79.1 ± 10.6 kg; height = 178.9 ± 7.5 cm) performed a high-volume resistance workout for lower body squat and leg extension, (5 sets of 10 reps at 70% of one repetition maximum for both exercises']","['ISOK25', 'placebo (PL', 'J Strength Cond Res XX(X', 'mud pack, containing menthol and Arnica montana', 'High-Volume Resistance Training Session', 'Mud Pack With Menthol and Arnica Montana Accelerates Recovery']","['recovery rate of strength and reduce muscle soreness', 'visual analog scale (VAS', 'CMJP, ISOK75, ISQ, and VLMT', 'ISOK25', 'Muscle performance (countermovement jump power [CMJP], isokinetic leg press at 75 cm·s and 25 cm·s', 'muscle soreness', ""Bartolomei, S, Nigro, F, D'Amico, A, Cortesi, M"", 'ISOK75 and ISOK25, respectively], isometric squat [ISQ]), and morphology (muscle thickness of vastus lateralis [VLMT]), were measured before exercise (baseline [BL]), and 15 minutes (15P), 24 hours (24P), and 48 hours (48P) postexercise']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0949364', 'cui_str': 'Mud Packs'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0331307', 'cui_str': 'Arnica montana'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0585043', 'cui_str': 'Before exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]",,0.0609809,A significant interaction between trials was noted for ISOK25,"[{'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Bartolomei', 'Affiliation': 'Department of Biomedical and Neuoromotor Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Nigro', 'Affiliation': 'Department for Life Quality Studies, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'DʼAmico', 'Affiliation': 'Department for Life Quality Studies, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cortesi', 'Affiliation': 'Department for Life Quality Studies, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Di Michele', 'Affiliation': 'Department of Biomedical and Neuoromotor Sciences, University of Bologna, Bologna, Italy.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003751']
2393,32956419,Early antiretroviral therapy for HIV-infected patients admitted to an intensive care unit (EARTH-ICU): A randomized clinical trial.,"BACKGROUND


Highly active antiretroviral therapy (HAART) has reduced HIV-related morbidity and mortality at all stages of infection and reduced transmission of HIV. Currently, the immediate start of HAART is recommended for all HIV patients, regardless of the CD4 count. There are several concerns, however, about starting treatment in critically ill patients. Unpredictable absorption of medication by the gastrointestinal tract, drug toxicity, drug interactions, limited reserve to tolerate the dysfunction of other organs resulting from hypersensitivity to drugs or immune reconstitution syndrome, and the possibility that subtherapeutic levels of drug may lead to viral resistance are the main concerns. The objective of our study was to compare the early onset (up to 5 days) with late onset (after discharge from the ICU) of HAART in HIV-infected patients admitted to the ICU.
METHODS


This was a randomized, open-label clinical trial enrolling HIV-infected patients admitted to the ICU of a public hospital in southern Brazil. Patients randomized to the intervention group had to start treatment with HAART within 5 days of ICU admission. For patients in the control group, treatment should begin after discharge from the ICU. The patients were followed up to determine mortality in the ICU, in the hospital and at 6 months. The primary outcome was hospital mortality. The secondary outcome was mortality at 6 months.
RESULTS


The calculated sample size was 344 patients. Unfortunately, we decided to discontinue the study due to a progressively slower recruitment rate. A total of 115 patients were randomized. The majority of admissions were for AIDS-defining illnesses and low CD4. The main cause of admission was respiratory failure. Regarding the early and late study groups, there was no difference in hospital (66.7% and 63.8%, p = 0.75) or 6-month (68.4% and 79.2%, p = 0.20) mortality. After multivariate analysis, the only independent predictors of in-hospital mortality were shock and dialysis during the ICU stay. For the mortality outcome at 6 months, the independent variables were shock and dialysis during the ICU stay and tuberculosis at ICU admission.
CONCLUSIONS


Although the early termination of the study precludes definitive conclusions being made, early HAART administration for HIV-infected patients admitted to the ICU compared to late administration did not show benefit in hospital mortality or 6-month mortality. ClinicalTrials.gov, NCT01455688. Registered 20 October 2011, https://clinicaltrials.gov/show/NCT01455688.",2020,"Regarding the early and late study groups, there was no difference in hospital (66.7% and 63.8%, p = 0.75) or 6-month (68.4% and 79.2%, p = 0.20) mortality.","['HIV-infected patients admitted to the ICU of a public hospital in southern Brazil', '344 patients', 'HIV-infected patients admitted to the ICU', '115 patients were randomized', 'HIV-infected patients admitted to an intensive care unit (EARTH-ICU', 'critically ill patients']","['HAART', 'active antiretroviral therapy (HAART']","['mortality at 6 months', 'hospital mortality or 6-month mortality', 'hospital mortality', 'hospital']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0242744', 'cui_str': 'Earth (Planet)'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0887947', 'cui_str': 'Highly active anti-retroviral therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",115.0,0.135629,"Regarding the early and late study groups, there was no difference in hospital (66.7% and 63.8%, p = 0.75) or 6-month (68.4% and 79.2%, p = 0.20) mortality.","[{'ForeName': 'Márcio M', 'Initials': 'MM', 'LastName': 'Boniatti', 'Affiliation': 'Critical Care Department, Hospital de Clínicas de Porto Alegre, Universidade La Salle, Porto Alegre, Brazil.'}, {'ForeName': 'José Augusto S', 'Initials': 'JAS', 'LastName': 'Pellegrini', 'Affiliation': 'Critical Care Department, Hospital de Clínicas de Porto Alegre, Universidade La Salle, Porto Alegre, Brazil.'}, {'ForeName': 'Leonardo S', 'Initials': 'LS', 'LastName': 'Marques', 'Affiliation': 'Critical Care Department, Hospital Nossa Senhora da Conceição, Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Josiane F', 'Initials': 'JF', 'LastName': 'John', 'Affiliation': 'Critical Care Department, Hospital de Clínicas de Porto Alegre, Universidade La Salle, Porto Alegre, Brazil.'}, {'ForeName': 'Luiz G', 'Initials': 'LG', 'LastName': 'Marin', 'Affiliation': 'Critical Care Department, Hospital Nossa Senhora da Conceição, Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Lina R D M', 'Initials': 'LRDM', 'LastName': 'Maito', 'Affiliation': 'Critical Care Department, Hospital São Vicente de Paulo, Passo Fundo, Brazil.'}, {'ForeName': 'Thiago C', 'Initials': 'TC', 'LastName': 'Lisboa', 'Affiliation': 'Critical Care Department, Hospital de Clínicas de Porto Alegre, Instituto de Pesquisa HCor, Universidade La Salle, Porto Alegre, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Instituto de Pesquisa HCor, Sao Paulo, Brazil.'}, {'ForeName': 'Diego R', 'Initials': 'DR', 'LastName': 'Falci', 'Affiliation': 'Infectious Disease Department, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}]",PloS one,['10.1371/journal.pone.0239452']
2394,31050355,"Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study.","AIMS


Rituximab is standard care in a number of lymphoma subtypes, including follicular lymphoma (FL), although many patients are resistant to rituximab, or develop resistance with repeated treatment, and a high proportion relapse. Obinutuzumab is a novel anti-CD20 monoclonal antibody with improved efficacy over rituximab. It is approved for previously untreated chronic lymphocytic leukaemia (CLL), and for use with bendamustine in patients with rituximab-relapsed/refractory FL.
METHODS


Using a previously described population pharmacokinetic (PK) model of obinutuzumab in patients with non-Hodgkin lymphoma and CLL, we conducted an exposure-response analysis using data from 6 clinical trials in patients with CD20+ B-cell malignancies (CLL11, GADOLIN, GATHER, GAUDI, GAUGUIN and GAUSS) to describe the PK properties of obinutuzumab, identify covariates influencing exposure, and explore how exposure affects safety, efficacy and pharmacodynamics.
RESULTS


A 2-compartment model with linear and time-dependent clearance described obinutuzumab PK. Disease type and subtype, body weight, baseline tumour size, and sex had the largest effects on PK. Obinutuzumab exposure was not associated with occurrence or severity of adverse events, but higher exposure appeared to be associated with greater efficacy, particularly longer progression-free survival. However, in multivariate Cox regression analysis, progression-free survival benefit in the obinutuzumab plus bendamustine arm was independent of exposure.
CONCLUSION


The updated population PK model reported here accurately describes the PK of obinutuzumab patients with non-Hodgkin lymphoma and CLL. The selected obinutuzumab dosing regimen offers clinical benefit in a majority of rituximab-refractory FL patients treated with bendamustine, irrespective of variability in exposure, whilst minimising adverse events.",2019,The updated population PK model reported here accurately describes the PK of obinutuzumab patients with non-Hodgkin lymphoma and CLL.,"['rituximab-refractory follicular lymphoma patients', 'patients with CD20+ B-cell malignancies (CLL11', 'obinutuzumab patients with non-Hodgkin lymphoma and CLL', 'patients with non-Hodgkin lymphoma and CLL', 'patients with rituximab-relapsed/refractory FL']","['Rituximab', 'Obinutuzumab', 'obinutuzumab', 'rituximab']","['Pharmacokinetics, exposure, efficacy and safety', 'progression-free survival', 'occurrence or severity of adverse events', 'progression-free survival benefit']","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0247724,The updated population PK model reported here accurately describes the PK of obinutuzumab patients with non-Hodgkin lymphoma and CLL.,"[{'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Gibiansky', 'Affiliation': 'QuantPharm LLC, North Potomac, MD, USA.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Gibiansky', 'Affiliation': 'QuantPharm LLC, North Potomac, MD, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Buchheit', 'Affiliation': 'Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Frey', 'Affiliation': 'Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brewster', 'Affiliation': 'Clinical Development, Roche Innovation Center Welwyn, Welwyn Garden City, UK.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'Pharma Development Clinical Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Jamois', 'Affiliation': 'Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.13974']
2395,31173468,Patient-reported outcomes in patients chronic viral hepatitis without cirrhosis: The impact of hepatitis B and C viral replication.,"BACKGROUND & AIM


Chronic infections with hepatitis B or C (HBV and HCV) are associated with adverse clinical outcomes and patient-reported outcomes (PROs). The aim is to compare PRO scores in patients with chronic HBV and HCV without advanced liver disease before and after suppression/clearance of their infection.
METHODS


Patients with HCV and HBV infection prior to initiation of antiviral treatment and after viral suppression/eradication completed PRO questionnaires.
RESULTS


We included 132 patients with HBV and 132 matched patients with HCV. Baseline PRO scores were significantly higher in patients with HBV in the domains of Physical Functioning, Role Physical, Bodily Pain, Social Functioning, and Role Emotional of SF-36, SF-6D utility, Emotional and Fatigue domains of CLDQ, Presenteeism and total Work Productivity Impairment of WPAI:SHP in comparison to patients with HCV by 5.8%-13.2% of a PRO score range (all P < 0.05). After viral suppression (HBV DNA < 20 IU/mL after 48 weeks of treatment for HBV) or eradication (SVR-12 for HCV), only Physical Functioning and Role Physical scores remained higher in HBV by 6.7%-9.9%, while other PRO scores became similar between HBV and HCV groups (P > 0.05). The most prominent improvement of PROs in HCV was noted in Vitality, Emotional, Fatigue and Worry domains. In addition, General Health, Worry and Work Productivity scores were the most improved in HBV.
CONCLUSIONS


Prior to treatment, PRO scores were lower in patients with HCV in comparison to HBV. After successful treatment, both groups of patients experienced improvement in some PRO domains confirming the positive impact of treatment.",2019,"Baseline PRO scores were significantly higher in patients with HBV in the domains of Physical Functioning, Role Physical, Bodily Pain, Social Functioning, and Role Emotional of SF-36, SF-6D utility,","['132 patients with HBV and 132 matched patients with HCV', 'Patients with HCV and HBV infection prior to initiation of antiviral treatment and after viral suppression/eradication completed PRO questionnaires', 'patients chronic viral hepatitis without cirrhosis', 'patients with chronic HBV and HCV without advanced liver disease before and after suppression/clearance of their infection']",['viral suppression (HBV DNA'],"['Baseline PRO scores', 'PROs in HCV', 'Physical Functioning, Role Physical, Bodily Pain, Social Functioning, and Role Emotional of SF-36, SF-6D utility', 'PRO scores', 'Vitality, Emotional, Fatigue and Worry domains', 'Emotional and Fatigue domains of CLDQ, Presenteeism and total Work Productivity Impairment', 'General Health, Worry and Work Productivity scores', 'Physical Functioning and Role Physical scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0276623', 'cui_str': 'Chronic viral hepatitis'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]",132.0,0.0276271,"Baseline PRO scores were significantly higher in patients with HBV in the domains of Physical Functioning, Role Physical, Bodily Pain, Social Functioning, and Role Emotional of SF-36, SF-6D utility,","[{'ForeName': 'Zobair M', 'Initials': 'ZM', 'LastName': 'Younossi', 'Affiliation': 'Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Stepanova', 'Affiliation': 'Center for Outcomes Research in Liver Disease, Washington, District of Columbia.'}, {'ForeName': 'Issah', 'Initials': 'I', 'LastName': 'Younossi', 'Affiliation': 'Center for Outcomes Research in Liver Disease, Washington, District of Columbia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Papatheodoridis', 'Affiliation': 'Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Harry L A', 'Initials': 'HLA', 'LastName': 'Janssen', 'Affiliation': 'Toronto Centre for Liver Disease, University Health Network, Toronto, Canada.'}, {'ForeName': 'Kosh', 'Initials': 'K', 'LastName': 'Agarwal', 'Affiliation': 'Institute of Liver Studies, London, United Kingdom.'}, {'ForeName': 'Mindie H', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Gane', 'Affiliation': 'Auckland Clinical Studies, Auckland, New Zealand.'}, {'ForeName': 'Naoky', 'Initials': 'N', 'LastName': 'Tsai', 'Affiliation': 'Queens Medical Center, University of Hawaii, Honolulu, Hawaii.'}, {'ForeName': 'Fatema', 'Initials': 'F', 'LastName': 'Nader', 'Affiliation': 'Center for Outcomes Research in Liver Disease, Washington, District of Columbia.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14171']
2396,31238715,Pre-pregnancy parental BMI and offspring blood pressure in infancy.,"AIMS


A growing body of evidence suggests that a higher maternal pre-pregnancy body mass index results in higher offspring's blood pressure, but there is inconsistency about the impact of father's body mass index. Furthermore, evidence is limited with regard to low and middle income countries. We aimed to determine the association between parental pre-pregnancy body mass index and offspring's blood pressure during the first year of life.
METHODS


In 587 infants of the BReastfeeding Attitude and Volume Optimization (BRAVO) trial systolic and diastolic blood pressure were measured twice at the right leg in a supine position, using an automatic oscillometric device at day 7, month 1, 2, 4, 6, 9 and 12. Parental pre-pregnancy body mass index was based on self-reported weight and height. Linear mixed models were performed to investigate the associations between parental pre-pregnancy body mass index and offspring blood pressure patterns.
RESULTS


Each unit increase in maternal body mass index was associated with 0.24 mmHg (95% confidence interval 0.05; 0.44) and 0.13 mmHg (0.01; 0.25) higher offspring's mean systolic and diastolic blood pressure, respectively, during the first year of life. A higher offspring blood pressure with increased maternal pre-pregnancy body mass index was seen at birth and remained higher during the first year of life. The association with systolic blood pressure remained similar after including birth size and offspring's weight and height over time. The association with diastolic blood pressure attenuated slightly to a non-significant result after including these variables. Paternal body mass index was not associated with offspring's blood pressure.
CONCLUSION


Higher maternal pre-pregnancy body mass index, but not paternal pre-pregnancy body mass index, is associated with higher offspring blood pressure already from birth onwards.",2019,A higher offspring blood pressure with increased maternal pre-pregnancy body mass index was seen at birth and remained higher during the first year of life.,['587 infants of the'],[],"['blood pressure with increased maternal pre-pregnancy body mass index', 'Paternal body mass index', 'systolic blood pressure', 'mean systolic and diastolic blood pressure', 'BReastfeeding Attitude and Volume Optimization (BRAVO) trial systolic and diastolic blood pressure', 'Pre-pregnancy parental BMI and offspring blood pressure', 'maternal body mass index', 'diastolic blood pressure']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0337493', 'cui_str': 'Paternal'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",,0.0308112,A higher offspring blood pressure with increased maternal pre-pregnancy body mass index was seen at birth and remained higher during the first year of life.,"[{'ForeName': 'Maria Adriana Cornelia', 'Initials': 'MAC', 'LastName': 'Jansen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands.'}, {'ForeName': 'Geertje W', 'Initials': 'GW', 'LastName': 'Dalmeijer', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands.'}, {'ForeName': 'Siti Rf', 'Initials': 'SR', 'LastName': 'Saldi', 'Affiliation': 'Department of Child Health/Center for Clinical Epidemiology and Evidence Based Medicine (CEEBM), Cipto Mangunkusumo National General Hospital, Indonesia.'}, {'ForeName': 'Diederick E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Baharuddin', 'Affiliation': 'Budi Kemuliaan Hospital, Indonesia.'}, {'ForeName': 'Cuno Spm', 'Initials': 'CS', 'LastName': 'Uiterwaal', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands.'}, {'ForeName': 'Nikmah S', 'Initials': 'NS', 'LastName': 'Idris', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands.'}]",European journal of preventive cardiology,['10.1177/2047487319858157']
2397,31308062,Dose-Ranging and Cohort-Expansion Study of Monalizumab (IPH2201) in Patients with Advanced Gynecologic Malignancies: A Trial of the Canadian Cancer Trials Group (CCTG): IND221.,"PURPOSE


Monalizumab binds CD94/NKG2A, preventing HLA-E inhibition of tumor lymphocytes. A dose-ranging/cohort expansion trial of monalizumab for recurrent gynecologic malignancies was conducted to determine the recommended phase II dose (RP2D) and to explore clinical activity, pharmacokinetics, pharmacodynamics, safety, and immunogenicity.
PATIENTS AND METHODS


Participants (and part 2 expansion cohorts) included (i) platinum-sensitive ovarian, (ii) platinum-resistant ovarian, (iii) squamous cervical (CX), and (iv) epithelial endometrial (END) carcinomas. Part 1 assessed monalizumab at 1, 4, or 10 mg/kg every 2 weeks. In part 2, ≥4 patients/cohort underwent pre- and on-treatment tumor biopsies. Preset criteria determined cohort expansion.
RESULTS


A total of 58 participants were evaluable. The RP2D was 10 mg/kg i.v. every 2 weeks. Dose proportionality and 100% NKG2A saturation were observed. Related adverse events were mild: headache, abdominal pain, fatigue, nausea, and vomiting. Grade 3 related adverse events were nausea (1), vomiting (1), dehydration (1), fatigue (2), anorexia (1), dyspnea (1), and proctitis (1). Dose-limiting toxicities were not observed. Hematologic and biochemical changes were mild and not dose related. Best response was SD: part 1, 7 of 18 (39%) [3.4 months (1.4-5.5)], and part 2, 7 of 39 (18%) [1.7 months (CX) to 14.8 months (END)]. Neither a predictive biomarker for SD nor evidence of pharmacodynamic effects was identified. There was a trend to significance between a reduction in lymphocyte HLA-E total score and pharmacodynamics.
CONCLUSIONS


Monalizumab 10 mg/kg i.v. every 2 week is well tolerated in patients with pretreated gynecologic cancers. Short-term disease stabilization was observed. Future studies should assess combinations with other agents, including immunotherapeutics.",2019,"There was a trend to significance between a reduction in lymphocyte HLA-E total score and pharmacodynamics.
","['Participants (and part 2 expansion cohorts) included (i) platinum-sensitive ovarian, (ii) platinum-resistant ovarian, (iii) squamous cervical (CX), and (iv) epithelial endometrial (END) carcinomas', 'A total of 58 participants were evaluable', 'patients with pretreated gynecologic cancers', 'Patients with Advanced Gynecologic Malignancies', 'recurrent gynecologic malignancies']","['Monalizumab (IPH2201', 'monalizumab']","['Hematologic and biochemical changes', 'Dose-limiting toxicities', 'clinical activity, pharmacokinetics, pharmacodynamics, safety, and immunogenicity', 'NKG2A saturation', 'lymphocyte HLA-E total score and pharmacodynamics', 'nausea (1), vomiting (1), dehydration (1), fatigue (2), anorexia (1), dyspnea (1), and proctitis (1', 'headache, abdominal pain, fatigue, nausea, and vomiting']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0476089', 'cui_str': 'Endometrial carcinoma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",[],"[{'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0033246', 'cui_str': 'Proctitis'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",58.0,0.0520336,"There was a trend to significance between a reduction in lymphocyte HLA-E total score and pharmacodynamics.
","[{'ForeName': 'Anna V', 'Initials': 'AV', 'LastName': 'Tinker', 'Affiliation': 'BC Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Holger W', 'Initials': 'HW', 'LastName': 'Hirte', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Provencher', 'Affiliation': 'CHUM, Montreal, Quebec, Canada.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ritter', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'Hatem A', 'Initials': 'HA', 'LastName': 'Azim', 'Affiliation': 'Innate Pharma, Research and Development, Marseille, France.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Paralejas', 'Affiliation': 'BC Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Grenier', 'Affiliation': 'CHUM, Montreal, Quebec, Canada.'}, {'ForeName': 'Shirley-Ann', 'Initials': 'SA', 'LastName': 'Hahn', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Ramsahai', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Seymour', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Ontario, Canada. lseymour@ctg.queensu.ca.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0298']
2398,31309975,Treatment-Emergent Influenza Variant Viruses With Reduced Baloxavir Susceptibility: Impact on Clinical and Virologic Outcomes in Uncomplicated Influenza.,"BACKGROUND


Single-dose baloxavir rapidly reduces influenza virus titers and symptoms in patients with uncomplicated influenza, but viruses with reduced in vitro susceptibility due to amino acid substitutions at position 38 of polymerase acidic protein (PA/I38X) sometimes emerge.
METHODS


We evaluated the kinetics, risk factors, and effects on clinical and virologic outcomes of emergence of PA/I38X-substituted viruses.
RESULTS


Viruses containing PA/I38X substitutions were identified 3-9 days after baloxavir treatment in 9.7% (36/370) of patients, of whom 85.3% had transient virus titer rises. Median time to sustained cessation of infectious virus detection was 192, 48, and 96 hours in the baloxavir recipients with PA/I38X-substituted viruses, without PA/I38X-substituted viruses, and placebo recipients, respectively. The corresponding median times to alleviation of symptoms were 63.1, 51.0, and 80.2 hours, respectively. After day 5, symptom increases occurred in 11.5%, 8.0%, and 13.0%, respectively, and in 8.9% of oseltamivir recipients. Variant virus emergence was associated with lower baseline neutralizing antibody titers.
CONCLUSIONS


The emergence of viruses with PA/I38X substitutions following baloxavir treatment was associated with transient rises in infectious virus titers, prolongation of virus detectability, initial delay in symptom alleviation, and uncommonly with symptom rebound. The potential transmissibility of PA/I38X-substituted viruses requires careful study.
CLINICAL TRIAL REGISTRATION


NCT02954354.",2020,"Median time to sustained cessation of infectious virus detection was 192, 48, and 96 hours in the baloxavir recipients with PA/I38X-substituted viruses, without PA/I38X-substituted viruses, and placebo recipients, respectively.","['patients with uncomplicated influenza', 'Treatment-Emergent Influenza Variant Viruses With Reduced Baloxavir Susceptibility', 'Uncomplicated Influenza']",['baloxavir'],"['Median time to sustained cessation of infectious virus detection', 'infectious virus titers, prolongation of virus detectability, initial delay in symptom alleviation', 'median times to alleviation of symptoms', 'symptom increases']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]","[{'cui': 'C4734224', 'cui_str': 'baloxavir'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1294356', 'cui_str': 'Detection of virus'}, {'cui': 'C2713348', 'cui_str': 'Virus Titer'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C5197672', 'cui_str': 'Symptom Exaggeration'}]",,0.0730268,"Median time to sustained cessation of infectious virus detection was 192, 48, and 96 hours in the baloxavir recipients with PA/I38X-substituted viruses, without PA/I38X-substituted viruses, and placebo recipients, respectively.","[{'ForeName': 'Takeki', 'Initials': 'T', 'LastName': 'Uehara', 'Affiliation': 'Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Kawaguchi', 'Affiliation': 'Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Omoto', 'Affiliation': 'Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Aeron C', 'Initials': 'AC', 'LastName': 'Hurt', 'Affiliation': 'Department of Microbiology and Immunology, Peter Doherty Institute for Infection and Immunity, University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Menno D', 'Initials': 'MD', 'LastName': 'De Jong', 'Affiliation': 'Department of Medical Microbiology, Academic Medical Center, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Hirotsu', 'Affiliation': 'Hirotsu Clinic, Kawasaki, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Sugaya', 'Affiliation': 'Department of Pediatrics, Keiyu Hospital, Yokohama, Japan.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Baba', 'Affiliation': 'Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Shishido', 'Affiliation': 'Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsuchiya', 'Affiliation': 'Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Portsmouth', 'Affiliation': 'Shionogi Inc., Florham Park, New Jersey.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kida', 'Affiliation': 'Research Center for Zoonosis Control, Hokkaido University, Sapporo, Japan.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz244']
2399,31358540,"Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab.","PURPOSE


Atezolizumab [anti-programmed death-ligand 1 (PD-L1)] selectively targets PD-L1 to block its interaction with receptors programmed death 1 and B7.1, thereby reinvigorating antitumor T-cell activity. We evaluated the long-term safety and activity of atezolizumab, along with biological correlates of clinical activity endpoints, in a cohort of patients with melanoma in an ongoing phase Ia study (NCT01375842).
PATIENTS AND METHODS


Patients with unresectable or metastatic melanoma were enrolled to receive atezolizumab 0.1 to 20 mg/kg or ≥10 mg/kg every 3 weeks. Primary study objectives were safety and tolerability. Secondary objectives included investigator-assessed efficacy measures; pharmacodynamic and predictive biomarkers of antitumor activity were explored.
RESULTS


Forty-five patients were enrolled and were evaluable for safety. Most treatment-related adverse events (AE) were grade 1/2 (60%). Fatigue (44%), pruritus (20%), pyrexia (18%), and rash (18%) were the most common treatment-related AEs of any grade. No treatment-related deaths occurred. Overall response rate was 30% among 43 efficacy- evaluable patients, with a median duration of response of 62 months [95% CI, 35-not estimable (NE)]. Clinically meaningful long-term survival was observed, with a median overall survival of 23 months (95% CI, 9-66). Baseline biomarkers of tumor immunity [PD-L1 expression on immune cells, T effector (Teff), and antigen presentation gene signatures) and tumor mutational burden (TMB) were associated with improved response, progression-free survival, and overall survival.
CONCLUSIONS


Atezolizumab was well tolerated, with durable responses and survival in patients with melanoma. PD-L1 expression, TMB, and Teff signatures may indicate improved benefit with atezolizumab in these patients.",2019,"Overall response rate was 30% among 43 efficacy- evaluable patients, with a median duration of response of 62 months [95% CI, 35-not estimable (NE)].","['Forty-five patients were enrolled and were evaluable for safety', 'patients with melanoma in an ongoing phase Ia study (NCT01375842', 'Patients with Metastatic Melanoma', 'Patients with unresectable or metastatic melanoma', 'patients with melanoma']","['atezolizumab 0.1 to 20 mg/kg or ≥10 mg/kg every 3 weeks', 'atezolizumab', 'Atezolizumab [anti-programmed death-ligand 1 (PD-L1', 'Atezolizumab']","['pruritus', 'Overall response rate', 'safety and tolerability', 'response, progression-free survival, and overall survival', 'Baseline biomarkers of tumor immunity [PD-L1 expression on immune cells, T effector (Teff), and antigen presentation gene signatures) and tumor mutational burden (TMB', 'rash', 'investigator-assessed efficacy measures; pharmacodynamic and predictive biomarkers of antitumor activity', 'Clinically meaningful long-term survival', 'median overall survival', 'pyrexia', 'Safety, Clinical Activity, and Biological Correlates of Response', 'Fatigue']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}]","[{'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0206431', 'cui_str': 'Antigen Presentation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",45.0,0.238583,"Overall response rate was 30% among 43 efficacy- evaluable patients, with a median duration of response of 62 months [95% CI, 35-not estimable (NE)].","[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, California. ohamid@theangelesclinic.org.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Molinero', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bolen', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sosman', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muñoz-Couselo', 'Affiliation': ""Vall d'Hebrón University Hospital and Vall d'Hebrón Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Harriet M', 'Initials': 'HM', 'LastName': 'Kluger', 'Affiliation': 'Yale University School of Medicine and Yale Cancer Center, New Haven, Connecticut.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Powderly', 'Affiliation': 'Carolina BioOncology Institute, Huntersville, North Carolina.'}, {'ForeName': 'Indrani', 'Initials': 'I', 'LastName': 'Sarkar', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ballinger', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Fassò', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': ""O'Hear"", 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Chen', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Priti S', 'Initials': 'PS', 'LastName': 'Hegde', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-3488']
2400,31420360,Nomogram to Predict the Benefit of Intensive Treatment for Locoregionally Advanced Head and Neck Cancer.,"PURPOSE


Previous studies indicate that the benefit of therapy depends on patients' risk for cancer recurrence relative to noncancer mortality (ω ratio). We sought to test the hypothesis that patients with head and neck cancer (HNC) with a higher ω ratio selectively benefit from intensive therapy.
EXPERIMENTAL DESIGN


We analyzed 2,688 patients with stage III-IVB HNC undergoing primary radiotherapy (RT) with or without systemic therapy on three phase III trials (RTOG 9003, RTOG 0129, and RTOG 0522). We used generalized competing event regression to stratify patients according to ω ratio and compared the effectiveness of intensive therapy as a function of predicted ω ratio (i.e., ω score). Intensive therapy was defined as treatment on an experimental arm with altered fractionation and/or multiagent concurrent systemic therapy. A nomogram was developed to predict patients' ω score on the basis of tumor, demographic, and health factors. Analysis was by intention to treat.
RESULTS


Decreasing age, improved performance status, higher body mass index, node-positive status, P16-negative status, and oral cavity primary predicted a higher ω ratio. Patients with ω score ≥0.80 were more likely to benefit from intensive treatment [5-year overall survival (OS), 70.0% vs. 56.6%; HR of 0.73, 95% confidence interval (CI): 0.57-0.94;  P  = 0.016] than those with ω score <0.80 (5-year OS, 46.7% vs. 45.3%; HR of 1.02, 95% CI: 0.92-1.14;  P  = 0.69;  P  = 0.019 for interaction). In contrast, the effectiveness of intensive therapy did not depend on risk of progression.
CONCLUSIONS


Patients with HNC with a higher ω score selectively benefit from intensive treatment. A nomogram was developed to help select patients for intensive therapy.",2019,"Patients with ω score ≥0.80 were more likely to benefit from intensive treatment [5-year overall survival (OS), 70.0% vs. 56.6%; HR of 0.73, 95% confidence interval (CI): 0.57-0.94;  P  = 0.016] than those with ω score <0.80 (5-year OS, 46.7% vs. 45.3%; HR of 1.02, 95% CI: 0.92-1.14;  P  = 0.69;  P  = 0.019 for interaction).","['patients with head and neck cancer (HNC) with a higher ω ratio selectively benefit from intensive therapy', '2,688 patients with stage III-IVB HNC undergoing primary radiotherapy (RT) with or without systemic therapy on three phase III trials (RTOG 9003, RTOG 0129, and RTOG 0522', 'Locoregionally Advanced Head and Neck Cancer']",[],"['5-year overall survival (OS', 'performance status, higher body mass index, node-positive status, P16-negative status, and oral cavity primary', 'risk of progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",2688.0,0.15266,"Patients with ω score ≥0.80 were more likely to benefit from intensive treatment [5-year overall survival (OS), 70.0% vs. 56.6%; HR of 0.73, 95% confidence interval (CI): 0.57-0.94;  P  = 0.016] than those with ω score <0.80 (5-year OS, 46.7% vs. 45.3%; HR of 1.02, 95% CI: 0.92-1.14;  P  = 0.69;  P  = 0.019 for interaction).","[{'ForeName': 'Loren K', 'Initials': 'LK', 'LastName': 'Mell', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California. lmell@ucsd.edu.'}, {'ForeName': 'Hanjie', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Phuc Felix', 'Initials': 'PF', 'LastName': 'Nguyen-Tân', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montreal, Montreal, Quebec, Canada.""}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Kaveh', 'Initials': 'K', 'LastName': 'Zakeri', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Lucas K', 'Initials': 'LK', 'LastName': 'Vitzthum', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Frank', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Schiff', 'Affiliation': 'Department of Radiation Oncology, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Andy M', 'Initials': 'AM', 'LastName': 'Trotti', 'Affiliation': 'Department of Radiation Oncology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Bonner', 'Affiliation': 'Department of Radiation Oncology, Hazelrig-Salter Radiation Oncology Center, The University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Christopher U', 'Initials': 'CU', 'LastName': 'Jones', 'Affiliation': 'Radiological Associates of Sacramento, Sacramento, California.'}, {'ForeName': 'Sue S', 'Initials': 'SS', 'LastName': 'Yom', 'Affiliation': 'Department of Radiation Oncology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Wade L', 'Initials': 'WL', 'LastName': 'Thorstad', 'Affiliation': 'Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Wong', 'Affiliation': 'Division of Hematology Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Shenouda', 'Affiliation': 'Department of Radiation Oncology, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Qiang E', 'Initials': 'QE', 'LastName': 'Zhang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Quynh-Thu', 'Initials': 'QT', 'LastName': 'Le', 'Affiliation': 'Department of Radiation Oncology, Stanford University School of Medicine, Stanford, California.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1832']
2401,31515458,Response to Anti-EGFR Therapy in Patients with BRAF non-V600-Mutant Metastatic Colorectal Cancer.,"PURPOSE


While mutations in BRAF in metastatic colorectal cancer (mCRC) most commonly occur at the V600 amino acid, with the advent of next-generation sequencing, non-V600 BRAF mutations are increasingly identified in clinical practice. It is unclear whether these mutants, like BRAF V600E, confer resistance to anti-EGFR therapy.
EXPERIMENTAL DESIGN


We conducted a multicenter pooled analysis of consecutive patients with non-V600 BRAF-mutated mCRCs identified between 2010 and 2017. Non-V600 BRAF mutations were divided into functional classes based on signaling mechanism and kinase activity: activating and RAS-independent (class 2) or kinase-impaired and RAS-dependent (class 3).
RESULTS


Forty patients with oncogenic non-V600 BRAF-mutant mCRC received anti-EGFR antibody treatment [ n  = 12 (30%) class 2 and  n  = 28 (70%) class 3]. No significant differences in clinical characteristics were observed by mutation class. In contrast, while only 1 of 12 patients with class 2 BRAF mCRC responded, 14 of 28 patients with class 3 BRAF responded to anti-EGFR therapy (response rate, 8% and 50%, respectively,  P  = 0.02). Specifically, in first- or second-line, 1 of 6 (17%) patients with class 2 and 7 of 9 (78%) patients with class 3 BRAF mutants responded ( P  = 0.04). In third- or later-line, none of 6 patients with class 2 and 7 of 19 (37%) patients with class 3 BRAF mutants responded ( P  = 0.14).
CONCLUSIONS


Response to EGFR antibody treatment in mCRCs with class 2 BRAF mutants is rare, while a large portion of CRCs with class 3 BRAF mutants respond. Patients with colorectal cancer with class 3 BRAF mutations should be considered for anti-EGFR antibody treatment. See related commentary by Fontana and Valeri, p. 6896 .",2019,No significant differences in clinical characteristics were observed by mutation class.,"['Patients with colorectal cancer with class 3 BRAF mutations', 'consecutive patients with non-V600 BRAF-mutated mCRCs identified between 2010 and 2017. Non-V600 BRAF mutations', 'Patients with BRAF non-V600-Mutant Metastatic Colorectal Cancer', 'metastatic colorectal cancer (mCRC', 'Forty patients with oncogenic non-V600 BRAF-mutant mCRC']","['functional classes based on signaling mechanism and kinase activity: activating and RAS-independent (class 2) or kinase-impaired and RAS-dependent (class 3', 'Anti-EGFR Therapy']",['clinical characteristics'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C2004436', 'cui_str': 'Activity therapy'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}]",40.0,0.0160218,No significant differences in clinical characteristics were observed by mutation class.,"[{'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Yaeger', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kotani', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Mondaca', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Aparna R', 'Initials': 'AR', 'LastName': 'Parikh', 'Affiliation': 'Massachusetts General Hospital Cancer Center and Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Van Seventer', 'Affiliation': 'Massachusetts General Hospital Cancer Center and Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.'}, {'ForeName': 'HuiYong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Molecular Pharmacology and Chemistry, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Claire N', 'Initials': 'CN', 'LastName': 'Thant', 'Affiliation': 'Program in Molecular Pharmacology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'de Stanchina', 'Affiliation': 'Department of Molecular Pharmacology and Chemistry, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Rosen', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Ryan B', 'Initials': 'RB', 'LastName': 'Corcoran', 'Affiliation': 'Massachusetts General Hospital Cancer Center and Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Ebi', 'Affiliation': 'Division of Molecular Therapeutics, Aichi Cancer Center Research Institute, Nagoya, Aichi, Japan. hebi@aichi-cc.jp.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2004']
2402,32964868,Single-incision versus four-port laparoscopic cholecystectomy in an ambulatory surgery setting: A prospective randomised double-blind controlled trial.,"Background


Single-incision laparoscopic cholecystectomy (SILC) can be done as a day-case procedure and may have advantages over conventional laparoscopic cholecystectomy (LC). We present the results of our study looking at post-operative pain and post-operative recovery time.
Methods


This was a single-institution randomised double-blind controlled trial. Seventy-three patients with symptomatic cholelithiasis were randomized to SILC (n = 37) or LC (n = 36). The primary endpoint was to compare post-operative pain. We also compared surgical time, procedural difficulty, adverse events, additional ports used and conversion rate, success of day surgery process, return to work, aesthetic satisfaction, quality of life and 4-year incisional hernia rate.
Results


In the SILC group, post-operative analgesic requirements were lower on day 7, there was an earlier return to work and cosmetic satisfaction was significantly higher. The SILC procedure presented a higher technical difficulty. Operative time, surgical complications, post-operative pain, success of the day-case process, return to normal activity, quality of life scores and incisional hernia rates were similar for both the procedures.
Conclusions


SILC has advantages over LC in terms of late post-operative analgesic requirements and aesthetic results; however, it is technically harder to perform. There was no benefit in terms of day surgery outcomes.",2020,"In the SILC group, post-operative analgesic requirements were lower on day 7, there was an earlier return to work and cosmetic satisfaction was significantly higher.","['Seventy-three patients with symptomatic cholelithiasis', 'ambulatory surgery setting']","['\n\n\nSingle-incision laparoscopic cholecystectomy (SILC', 'Single-incision versus four-port laparoscopic cholecystectomy', 'conventional laparoscopic cholecystectomy (LC', 'SILC', 'LC']","['earlier return to work and cosmetic satisfaction', 'post-operative analgesic requirements', 'Operative time, surgical complications, post-operative pain, success of the day-case process, return to normal activity, quality of life scores and incisional hernia rates', 'surgical time, procedural difficulty, adverse events, additional ports used and conversion rate, success of day surgery process, return to work, aesthetic satisfaction, quality of life and 4-year incisional hernia rate', 'post-operative pain']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0282046', 'cui_str': 'Day Surgery'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0439234', 'cui_str': 'year'}]",73.0,0.246574,"In the SILC group, post-operative analgesic requirements were lower on day 7, there was an earlier return to work and cosmetic satisfaction was significantly higher.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Subirana', 'Affiliation': 'Department of General Surgery, Hospital Moisès Broggi, Consorci Sanitari Integral, Barcelona, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Rey', 'Affiliation': ""Department of General Surgery, Hospital General de l'Hospitalet, Consorci Sanitari Integral, Barcelona, Spain.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Barri', 'Affiliation': ""Department of General Surgery, Hospital General de l'Hospitalet, Consorci Sanitari Integral, Barcelona, Spain.""}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Robres', 'Affiliation': ""Department of General Surgery, Hospital General de l'Hospitalet, Consorci Sanitari Integral, Barcelona, Spain.""}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Parra', 'Affiliation': ""Department of Anesthesiology, Hospital General de l'Hospitalet, Consorci Sanitari Integral, Barcelona, Spain.""}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Martín', 'Affiliation': ""Department of Clinical Epidemiology, Hospital General de l'Hospitalet, Consorci Sanitari Integral, Barcelona, Spain.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Memba', 'Affiliation': 'Department of General Surgery, Hospital Universitari Joan XXIII de Tarragona, Tarragona, Spain.'}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Mullerat', 'Affiliation': 'Department of General Surgery, Hospital Moisès Broggi, Consorci Sanitari Integral, Barcelona, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Jorba', 'Affiliation': 'Department of General Surgery, Hospital Universitari Joan XXIII de Tarragona, Tarragona, Spain.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_97_20']
2403,32964883,Preservation of the left colic artery and superior rectal artery in laparoscopic surgery can reduce anastomotic leakage in sigmoid colon cancer.,"Background


The aim was to study the clinical significance in the preservation of the left colic artery (LCA) and superior rectal artery (SRA) for the laparoscopic resection of sigmoid colon cancer (SCC).
Patients and Methods


A total of 316 patients with SCC were divided into two groups. Group A received D3 resection with preservation of LCA and SRA, whereas Group B ligatured artery at the root of the inferior mesenteric artery. The operation time, number of resected lymph nodes, blood loss and anastomotic leakage rate were compared.
Results


In Group A, the average operation time was 283.02 ± 51.48 min, the average blood loss was 111.81 ± 77.08 ml and the average lymph node dissection was 14.8 ± 7.7. There was no statistical significance in blood loss and number of resected lymph nodes between Group A and B (P > 0.05). Longer operating time were observed in Group A as compared to Group B (P < 0.05). The anastomotic leakage rate had statistical significance between these two groups (P < 0.05).
Conclusions


Preservation of LCA and SRA was safe and feasible for the laparoscopic surgery of SCC, which could reduce anastomotic leakage rate.",2020,There was no statistical significance in blood loss and number of resected lymph nodes between Group A and B (P > 0.05).,"['sigmoid colon cancer (SCC', 'Patients and Methods\n\n\nA total of 316 patients with SCC', 'sigmoid colon cancer']","['D3 resection with preservation of LCA and SRA', 'LCA and SRA', 'laparoscopic surgery', 'left colic artery (LCA) and superior rectal artery (SRA']","['average operation time', 'anastomotic leakage', 'blood loss and number of resected lymph nodes', 'operation time, number of resected lymph nodes, blood loss and anastomotic leakage rate', 'Longer operating time', 'anastomotic leakage rate', 'average blood loss']","[{'cui': 'C0153436', 'cui_str': 'Malignant tumor of sigmoid colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450356', 'cui_str': '316'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0226322', 'cui_str': 'Structure of colic artery'}, {'cui': 'C0226331', 'cui_str': 'Structure of superior rectal artery'}, {'cui': 'C0226318', 'cui_str': 'Structure of left colic artery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}]",316.0,0.0346752,There was no statistical significance in blood loss and number of resected lymph nodes between Group A and B (P > 0.05).,"[{'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of General Surgery, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Mengjun', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of General Surgery, Lanling People's Hospital, Linyi, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Qingsi', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Department of General Surgery, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Guorui', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': 'Department of General Surgery, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Qu', 'Affiliation': 'Department of General Surgery, Qilu Hospital of Shandong University, Jinan, China.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_15_20']
2404,32964915,Care Starts at Home: Emotional State and Appeals to Altruism may Reduce Demand for Overused Health Services in the UK.,"BACKGROUND


Overuse of unnecessary services, screening tests, and treatments is an ongoing problem for national health care systems. Overuse is at least partly driven by patient demand.
PURPOSE


This study examined whether altering patients' emotional state and appealing to patient altruism would reduce demand for three commonly overused UK health services.
METHODS


In an online experiment, 1,267 UK volunteers were randomized to anxiety, compassion, or neutral conditions before viewing three overuse vignettes. In each vignette, use of the health service was recommended against by the doctor and participants were further randomized to one of three altruism frames, emphasizing the impact of overuse on the self, the self and others locally, or the self and others nationally. Participants rated the likelihood that they would pursue the health service and, assuming that they did not, how long they would be willing-to-wait for it.
RESULTS


Altruism frame had a small effect on intentions to use the health service. Those in the local or national (vs. self) frame were 4.7 and 6.1 percentage points, respectively, less likely to ask for the service. Emotion induction had no direct effect on outcomes. However, self-reporting higher levels of anxiety or compassion post-induction was associated with a small, greater likelihood in intentions to ask for the health service or willingness-to-wait, respectively. No interactions between frame and emotion were observed.
CONCLUSIONS


As a low-cost initiative, emphasizing the benefits to the self and local or national communities could be embedded in appeals designed to appropriately reduce health care overuse in the UK.",2020,Emotion induction had no direct effect on outcomes.,"['1,267 UK volunteers were randomized to anxiety, compassion, or neutral conditions before viewing three overuse vignettes']",[],['small effect on intentions to use the health service'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0449911', 'cui_str': 'View'}]",[],"[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",1267.0,0.0479352,Emotion induction had no direct effect on outcomes.,"[{'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Powell', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Economics, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gabbay', 'Affiliation': 'Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Nathan S', 'Initials': 'NS', 'LastName': 'Consedine', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa058']
2405,32964918,"Double-blind, randomized, placebo-controlled trial with N-acetylcysteine for treatment of severe acute respiratory syndrome caused by COVID-19.","BACKGROUND


A local increase in angiotensin 2 after inactivation of angiotensin-converting enzyme 2 by SARS-CoV-2 may induce a redox imbalance in alveolar epithelium cells, causing apoptosis, increased inflammation and, consequently, impaired gas exchange. We hypothesized that N-acetylcysteine (NAC) administration could restore this redox homeostasis and suppress unfavorable evolution in Covid-19 patients.
OBJECTIVE


To determine whether NAC in high doses can avoid respiratory failure in patients with Covid-19.
METHODS


It was a double-blind, randomized, placebo-controlled, unicentric trial, conducted at the Emergency Department of Hospital das Clínicas, São Paulo, Brazil. We enrolled 135 patients with severe Covid-19 (confirmed or suspected), with an oxyhemoglobin saturation of less than 94% or respiratory rate higher than 24 breaths/min. Patients were randomized to receive NAC 21 g (approximately 300 mg/kg) for 20 hours, or dextrose 5%. Primary endpoint was the need for mechanical ventilation. Secondary endpoints were time of mechanical ventilation, admission to ICU, time in ICU, and mortality.
RESULTS


Baseline characteristics were very similar in the two groups, with no significant difference in age, sex, comorbidities, medicines taken, and disease severity. Also, groups were similar in laboratory tests and chest CT scan findings. Sixteen patients (23.9%) in the Placebo group were submitted to endotracheal intubation and mechanical ventilation, compared to 14 patients (20.6%) in the NAC group (p=0.675). No difference was observed in secondary endpoints.
CONCLUSION


Administration of NAC in high doses did not affect the evolution of severe Covid-19.",2020,"Sixteen patients (23.9%) in the Placebo group were submitted to endotracheal intubation and mechanical ventilation, compared to 14 patients (20.6%) in the NAC group (p=0.675).","['severe acute respiratory syndrome caused by COVID-19', 'patients with Covid-19', '135 patients with severe Covid-19 (confirmed or suspected), with an oxyhemoglobin saturation of less than 94% or respiratory rate higher than 24 breaths/min', 'Emergency Department of Hospital das Clínicas, São Paulo, Brazil']","['endotracheal intubation and mechanical ventilation', 'placebo', 'NAC', 'N-acetylcysteine', 'Placebo', 'N-acetylcysteine (NAC']","['time of mechanical ventilation, admission to ICU, time in ICU, and mortality', 'evolution of severe Covid-19', 'need for mechanical ventilation']","[{'cui': 'C1175175', 'cui_str': 'Severe acute respiratory syndrome'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",135.0,0.686173,"Sixteen patients (23.9%) in the Placebo group were submitted to endotracheal intubation and mechanical ventilation, compared to 14 patients (20.6%) in the NAC group (p=0.675).","[{'ForeName': 'Julio Cesar Garcia', 'Initials': 'JCG', 'LastName': 'de Alencar', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Claudia de Lucena', 'Initials': 'CL', 'LastName': 'Moreira', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alicia Dudy', 'Initials': 'AD', 'LastName': 'Müller', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cleuber Esteves', 'Initials': 'CE', 'LastName': 'Chaves', 'Affiliation': 'Pharmacy Division, Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marina Akemi', 'Initials': 'MA', 'LastName': 'Fukuhara', 'Affiliation': 'Pharmacy Division, Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Elizabeth Aparecida', 'Initials': 'EA', 'LastName': 'da Silva', 'Affiliation': 'Pharmacy Division, Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria de Fátima Silva', 'Initials': 'MFS', 'LastName': 'Miyamoto', 'Affiliation': 'Pharmacy Division, Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vanusa Barbosa', 'Initials': 'VB', 'LastName': 'Pinto', 'Affiliation': 'Pharmacy Division, Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cauê Gasparotto', 'Initials': 'CG', 'LastName': 'Bueno', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Felippe', 'Initials': 'F', 'LastName': 'Lazar', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luz Marina', 'Initials': 'LM', 'LastName': 'Gomez', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Clara Saad', 'Initials': 'MCS', 'LastName': 'Menezes', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Julio Flavio Meirelles', 'Initials': 'JFM', 'LastName': 'Marchini', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lucas Oliveira', 'Initials': 'LO', 'LastName': 'Marino', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rodrigo Antônio', 'Initials': 'RA', 'LastName': 'Brandão', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Heraldo Possolo', 'Initials': 'HP', 'LastName': 'Souza', 'Affiliation': 'Emergency Medicine Department, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1443']
2406,32965030,Efficacy of topical Calendula officinalis on prevalence of radiation-induced dermatitis: A randomised controlled trial.,"OBJECTIVES


A randomised controlled trial was undertaken to compare the efficacy of topical Calendula officinalis (Calendula) versus standard of care (Sorbolene: 10% glycerine in cetomacragol cream) in reducing the prevalence of radiation-induced dermatitis in women undergoing breast cancer radiotherapy.
METHODS


A total of 271 women were screened and 82 were randomised. The primary outcome was prevalence of acute radiation-induced dermatitis (RTOG grade 2+) assessed at multiple skin sites. A chi-squared test was conducted for the primary outcome with a worst-case scenario imputation.
RESULTS


The recruitment target (n = 178) was not achieved. A total of n = 81 participants were analysed (n = 40 Calendula; n = 41 Sorbolene). There was no detectable difference in prevalence of radiation-induced dermatitis grade 2+ between the Calendula (53%) and Sorbolene (62%) groups (primary analysis OR = 0.87, 95% CI: [0.36, 2.09], P = 0.92; covariate adjusted complete case analysis OR 0.40, 95% CI: [0.13, 1.20], P = 0.10).
CONCLUSION


This randomised controlled trial showed no difference between Calendula and standard of care (Sorbolene) for the prevention of radiation-induced dermatitis. However, the study was underpowered (limited recruitment) for the primary comparison.",2020,"There was no detectable difference in prevalence of radiation-induced dermatitis grade 2+ between the Calendula (53%) and Sorbolene (62%) groups (primary analysis OR = 0.87, 95% CI: [0.36, 2.09], P = 0.92; covariate adjusted complete case analysis OR 0.40, 95% CI: [0.13, 1.20], P = 0.10).
","['prevalence of radiation-induced dermatitis', 'A total of 271 women were screened and 82 were randomised', 'women undergoing breast cancer radiotherapy', 'A total of n\xa0=\xa081 participants were analysed (n\xa0=\xa040 Calendula; n\xa0=\xa041 Sorbolene']","['topical Calendula officinalis (Calendula) versus standard of care', 'Calendula and standard of care (Sorbolene', 'topical Calendula officinalis']","['prevalence of radiation-induced dermatitis', 'prevalence of radiation-induced dermatitis grade 2', 'prevalence of acute radiation-induced dermatitis (RTOG grade 2+) assessed at multiple skin sites']","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0752223', 'cui_str': 'Marigold'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0752222', 'cui_str': 'Calendula officinalis'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0752223', 'cui_str': 'Marigold'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",271.0,0.344656,"There was no detectable difference in prevalence of radiation-induced dermatitis grade 2+ between the Calendula (53%) and Sorbolene (62%) groups (primary analysis OR = 0.87, 95% CI: [0.36, 2.09], P = 0.92; covariate adjusted complete case analysis OR 0.40, 95% CI: [0.13, 1.20], P = 0.10).
","[{'ForeName': 'Shihab', 'Initials': 'S', 'LastName': 'Siddiquee', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'McGee', 'Affiliation': ""Freemasons Foundation Centre for Men's Health, University of Adelaide, Adelaide, Australia.""}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Vincent', 'Affiliation': ""Freemasons Foundation Centre for Men's Health, University of Adelaide, Adelaide, Australia.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Giles', 'Affiliation': 'Department of Allied Health and Human Performance, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Clothier', 'Affiliation': 'Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Carruthers', 'Affiliation': 'Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Penniment', 'Affiliation': 'Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia.'}]",The Australasian journal of dermatology,['10.1111/ajd.13434']
2407,32965037,Melatonin for Acute Treatment of Migraine in Children and Adolescents: A Pilot Randomized Trial.,"OBJECTIVE


To determine what dose of melatonin is most effective for treating migraine acutely in children and adolescents.
BACKGROUND


Acute migraine medications may not work for all patients and may cause side effects. Melatonin is effective for migraine prevention in adults and has been used acutely for procedural pain in children. Our goal was to determine whether a ""high"" or ""low"" dose of melatonin is more effective for treating migraine acutely in youth.
METHODS


In this pilot, randomized, open-label, single-center, dose-finding trial, children and adolescents aged 4-17 years with episodic migraine were randomized to ""high-dose"" or ""low-dose"" dose melatonin (<40 kg: 4 mg vs. 1 mg; ≥40 kg: 8 mg vs. 2 mg). The primary outcome measure was change in mean pain score between time 0 and 2 hours. Secondary outcomes included 2-hour pain-relief and pain-freedom rates.
RESULTS


Eighty-four participants (n = 42 per group) were enrolled in this study. Mean (SD) participant age was 11.8 (3.5) years and 55% (46/84) were female. Mean (SD) headache days/month was 5.6 (3.8). Sixty-six (79%) participants provided outcome data and were included in the analyses, n = 24 in the high-dose group and n = 22 in the low-dose group. The drop-out rate was 43% (18/42) in the high-dose group vs. 48% (20/42) in the low-dose group. Mean (SD) change in pain intensity at 2 hours was -2.7 (2.1) cm in the high-dose group vs. -2.3 (2.1) cm in the low-dose group (p = .581), a difference of 0.4 cm (95% CI: -1.17 to 1.92). Two-hour pain-freedom rate was 41% (7/17) vs. 27% (4/15) in the high-dose vs. low-dose groups (p = .415), and 2-hour pain-relief rate was 94% (16/17) vs. 80% (12/15), (p = .482). There were no serious adverse events. Napping occurred in the majority (67% (14/21) high dose vs. 47% (9/19) low dose). Higher mg/kg dose of melatonin and napping were each independently associated with greater headache benefit.
CONCLUSIONS


As an acute treatment for pediatric migraine, both low and high doses of melatonin were associated with pain reduction; however, study drop-out was high. Higher dose and napping after treatment predicted greater benefit.",2020,The drop-out rate was 43% (18/42) in the high-dose group vs. 48% (20/42) in the low-dose group.,"['n\xa0=\xa042 per group) were enrolled in this study', 'Eighty-four participants ', 'children and adolescents', 'Sixty-six (79%) participants provided outcome data and were included in the analyses, n\xa0', 'Children and Adolescents', 'children and adolescents aged 4-17\xa0years with episodic migraine', 'Mean (SD) participant age was 11.8 (3.5) years and 55% (46/84) were female']","['melatonin', 'high-dose"" or ""low-dose"" dose melatonin', 'Melatonin']","['mean pain score', 'Mean (SD) change in pain intensity', 'headache benefit', 'Mean (SD) headache days/month', '2-hour pain-relief and pain-freedom rates', '2-hour pain-relief rate', 'pain-freedom rate', 'serious adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.322068,The drop-out rate was 43% (18/42) in the high-dose group vs. 48% (20/42) in the low-dose group.,"[{'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gelfand', 'Affiliation': 'Department of Neurology, UCSF Child & Adolescent Headache Program, San Francisco, CA, USA.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Ross', 'Affiliation': 'Department of Pediatrics, UCSF Child & Adolescent Headache Program, San Francisco, CA, USA.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Irwin', 'Affiliation': 'Department of Neurology, UCSF Child & Adolescent Headache Program, San Francisco, CA, USA.'}, {'ForeName': 'Kaitlin A', 'Initials': 'KA', 'LastName': 'Greene', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Qubty', 'Affiliation': 'Pediatric Headache Program, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'I Elaine', 'Initials': 'IE', 'LastName': 'Allen', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, CA, USA.'}]",Headache,['10.1111/head.13934']
2408,32956756,"Efficacy and safety of mepolizumab in hypereosinophilic syndrome: a Phase III, randomized, placebo-controlled trial.","BACKGROUND


Anti-interleukin-5 therapy is a potential treatment for patients with hypereosinophilic syndrome (HES), although its clinical efficacy is unclear.background OBJECTIVE: To investigate the clinical efficacy and safety of mepolizumab versus placebo in patients with HES.
METHODS


This randomized, multicenter, double-blind, placebo-controlled, Phase III trial was conducted across 39 centers in 13 countries. Eligible patients had FIP1L1-PDGFRA-negative HES, experienced ≥2 flares (worsening of HES-related symptoms or blood eosinophil count requiring therapeutic escalation) in the previous 12 months and had a screening blood eosinophil count ≥1000 cells/μL. Patients were randomized (1:1) to subcutaneous mepolizumab (300 mg) or placebo every 4 weeks for 32 weeks, plus existing HES therapy. The primary outcome was the proportion of patients with ≥1 flare (worsening of HES-related symptoms necessitating therapy escalation or ≥2 courses of blinded rescue oral corticosteroids) during the study; in addition, patients who withdrew early from the study were counted as having a flare. Safety endpoints were also assessed.
RESULTS


The proportion of patients experiencing ≥1 flare/withdrawing from the study was 50% lower with mepolizumab versus placebo (15/54 [28%] vs 30/54 [56%]; p=0.002). Logistic regression analysis was consistent with the primary analysis (odds ratio: 0.28; 95% confidence interval: 0.12, 0.64; p=0.003). Similar proportions of patients in the mepolizumab and placebo groups experienced on-treatment adverse events (48/54 [89%] vs 47/54 [87%]).results CONCLUSION: Compared with placebo, mepolizumab significantly reduced the occurrence of flares in patients with HES, with no new safety signals identified.
CONCLUSION


",2020,"Logistic regression analysis was consistent with the primary analysis (odds ratio: 0.28; 95% confidence interval: 0.12, 0.64; p=0.003).","['hypereosinophilic syndrome', 'patients with HES', 'patients with hypereosinophilic syndrome (HES', 'Eligible patients had FIP1L1-PDGFRA-negative HES, experienced ≥2 flares (worsening of HES-related symptoms or blood eosinophil count requiring therapeutic escalation) in the previous 12 months and had a screening blood eosinophil count ≥1000 cells/μL. Patients', '39 centers in 13 countries']","['mepolizumab versus placebo', 'Anti-interleukin-5 therapy', 'plus existing HES therapy', 'mepolizumab', 'subcutaneous mepolizumab', 'placebo']","['Efficacy and safety', 'occurrence of flares', 'treatment adverse events', 'proportion of patients with ≥1 flare (worsening of HES-related symptoms necessitating therapy escalation or ≥2 courses of blinded rescue oral corticosteroids']","[{'cui': 'C0206141', 'cui_str': 'Idiopathic hypereosinophilic syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0860389', 'cui_str': 'Interleukin-5 therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0206141', 'cui_str': 'Idiopathic hypereosinophilic syndrome'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0206141', 'cui_str': 'Idiopathic hypereosinophilic syndrome'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",,0.685115,"Logistic regression analysis was consistent with the primary analysis (odds ratio: 0.28; 95% confidence interval: 0.12, 0.64; p=0.003).","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Roufosse', 'Affiliation': 'Department of Internal Medicine, Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: froufoss@ulb.ac.be.'}, {'ForeName': 'Jean-Emmanuel', 'Initials': 'JE', 'LastName': 'Kahn', 'Affiliation': 'Department of Internal Medicine, Hôpital Ambroise Paré, Université Versailles-Saint Quentin-en-Yvelines, Boulogne-Billancourt, France.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Rothenberg', 'Affiliation': ""Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, and the Department of Pediatrics, University of Cincinnati, Cincinnati, OH, USA.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Wardlaw', 'Affiliation': 'Institute for Lung Health, University of Leicester, Leicester, UK.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Klion', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Suyong Yun', 'Initials': 'SY', 'LastName': 'Kirby', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Martyn J', 'Initials': 'MJ', 'LastName': 'Gilson', 'Affiliation': 'Respiratory Research and Development, GSK, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Jane H', 'Initials': 'JH', 'LastName': 'Bentley', 'Affiliation': 'Clinical Statistics, GSK, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Bradford', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Yancey', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Steinfeld', 'Affiliation': 'Respiratory Research & Development, GSK, Collegeville, PA, USA.'}, {'ForeName': 'Gerald J', 'Initials': 'GJ', 'LastName': 'Gleich', 'Affiliation': 'Department of Dermatology, School of Medicine, University of Utah, Salt Lake City, UT, USA.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.08.037']
2409,32956890,"Ultrasound-Guided Erector Spinae Plane Block vs. modified-Thoracolumbar Interfascial Plane Block for Lumbar Discectomy Surgery: A Randomized, Controlled Study.","OBJECTIVES


This study aimed to compare the ultrasound (US)-guided erector spinae plane block (ESPB) and modified-thoracolumbar interfascial plane (mTLIP) block for postoperative pain management in lumbar discectomy surgery patients.
MATERIAL AND METHODS


A total of 90 patients scheduled for lumbar discectomy were randomly assigned into three groups (n = 30 per group): an ESPB group, a mTLIP group, and a control group. In the ESPB and mTLIP groups, a single-shot US-guided block was administered with 20 ml of 0.25% bupivacaine bilaterally. All patients received intravenous patient-controlled postoperative analgesia with fentanyl, one g intravenous paracetamol every six hours. Fentanyl consumption, visual analog pain scores (VAS), rescue analgesia, block procedure time, and side-effects.
RESULTS


Postoperative opioid consumption at all time intervals were significantly lower both in ESPB and mTLIP groups compared to the control group (p<0.05). No significant difference was observed concerning intraoperative and postoperative opioid consumption between the ESPB and the mTLIP group (p<0.001). Passive VAS at PACU, 2 nd , 4 th , 8 th  hours, and active VAS at PACU, 2 nd , 4 th , 8 th , 16 th  hours were significantly lower in the ESPB group and mTLIP group compared to the control group (p<0.05). The use of rescue analgesia was significantly lower in the ESPB and mTLIP groups than in the control group (9/30, 7/30, and 21/30, respectively, p<0.001). The block procedure time was similar between groups (p=0.198).
CONCLUSIONS


US-guided ESPB and mTLIP may provide adequate pain control after discectomy surgery. However, there is a non-superiority between ESPB and the mTLIP group.",2020,"RESULTS


Postoperative opioid consumption at all time intervals were significantly lower both in ESPB and mTLIP groups compared to the control group (p<0.05).","['lumbar discectomy surgery patients', '90 patients scheduled for lumbar discectomy', 'Lumbar Discectomy Surgery']","['bupivacaine', 'mTLIP', 'ESPB', 'intravenous patient-controlled postoperative analgesia with fentanyl, one g intravenous paracetamol', 'ultrasound (US)-guided erector spinae plane block (ESPB) and modified-thoracolumbar interfascial plane (mTLIP) block', 'Ultrasound-Guided Erector Spinae Plane Block vs. modified-Thoracolumbar Interfascial Plane Block']","['intraoperative and postoperative opioid consumption', 'Postoperative opioid consumption', 'rescue analgesia', 'block procedure time', 'Fentanyl consumption, visual analog pain scores (VAS), rescue analgesia, block procedure time, and side-effects']","[{'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",90.0,0.0508988,"RESULTS


Postoperative opioid consumption at all time intervals were significantly lower both in ESPB and mTLIP groups compared to the control group (p<0.05).","[{'ForeName': 'Bahadir', 'Initials': 'B', 'LastName': 'Ciftci', 'Affiliation': 'Medipol University School of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey. Electronic address: aliahiskalioglu@hotmail.com.'}, {'ForeName': 'Mürsel', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Medipol University School of Medicine, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'Erkan Cem', 'Initials': 'EC', 'LastName': 'Celik', 'Affiliation': 'Ataturk University School of Medicine, Department of Anesthesiology and Reanimation, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ahmet Murat', 'Initials': 'AM', 'LastName': 'Yayik', 'Affiliation': 'Ataturk University School of Medicine, Department of Anesthesiology and Reanimation, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Muhammed Enes', 'Initials': 'ME', 'LastName': 'Aydin', 'Affiliation': 'Ataturk University School of Medicine, Department of Anesthesiology and Reanimation, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahiskalioglu', 'Affiliation': 'Ataturk University School of Medicine, Department of Anesthesiology and Reanimation, Erzurum, Turkey; Clinical Research, Development and Design Application and Research Center, Ataturk University School of Medicine, Erzurum, Turkey.'}]",World neurosurgery,['10.1016/j.wneu.2020.09.077']
2410,32956906,Reality check: An experimental manipulation of inferential confusion in eating disorders.,"BACKGROUND AND OBJECTIVES


Inferential confusion (IC) entails confusing an imagined possibility with a sensory-based possibility, and acting upon the imagined possibility as if it was real. Although IC was formulated in the context of obsessive-compulsive disorder (OCD), this reasoning bias has shown to be relevant to other obsessive-compulsive spectrum disorders, such as eating disorders (EDs). The goal of this study was to induce IC experimentally in individuals with EDs relative to healthy controls (HC).
METHODS


Thirty-six women (ED group, n = 18; HC group, n = 18) were assigned to one of two experimental conditions: in the High IC condition, participants watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC. In the Low IC condition, participants watched videos without sequences missing. Participants completed measures of IC, negative affect and compulsive behaviors after watching the videos.
RESULTS


One-way ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors. ED participants also neutralized more after watching the videos and endorsed higher trait IC.
LIMITATIONS


There was no clinical control group.
CONCLUSIONS


These findings suggest that individuals with EDs display a greater vulnerability to IC, as they are more prone to compulsive behaviors when IC is triggered. This investigation may foster our understanding of the relationship between EDs and OCD through the examination of cognitive factors that are implicated in both disorders.",2020,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"['Thirty-six women (ED group, n\xa0=\xa018', 'individuals with EDs relative to healthy controls (HC', 'eating disorders']","['watched ED-themed videos with key sequences missing - provoking a distrust of the senses and lending more space for the imagination, thus triggering IC']","['urge to engage in compulsive behaviors', 'IC, negative affect and compulsive behaviors']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1867020', 'cui_str': 'Scalp, ear, nipple syndrome'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0020913', 'cui_str': 'Use of imagination'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",36.0,0.0589645,ANOVA indicated that ED participants assigned to the High IC condition reported a greater urge to engage in compulsive behaviors.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ouellet-Courtois', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychology Department, Canada. Electronic address: catherine.ouellet-courtois@umontreal.ca.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Aardema', 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}, {'ForeName': 'Kieron', 'Initials': 'K', 'LastName': ""O'Connor"", 'Affiliation': 'OCD Spectrum Study Center, Montreal Mental Health University Institute, 7331 Hochelaga Montreal, Quebec, H1N 3V2, Canada; Université de Montréal, Psychiatry Department, 2900, Boul. Édouard-Montpetit Montreal, Quebec, H3T 1J4, Canada.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101614']
2411,32956960,Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial.,"BACKGROUND


The transgenerational transmission of affective disorders calls for integrating promotion of child development in the services offered to families with parental depression. The main objective of the present research was to examine the effectiveness and differences in the impact of two relevant interventions in Greece.
METHODS


Thirty families of depressed patients were randomly assigned to the six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session Let's Talk about the Children group. Depressed parents and the eldest of their children were assessed prior to the interventions and 4, 10, and 18 months following baseline assessment.
RESULTS


In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems. Child's prosocial behavior, perceived social support, and health-related quality of life were significantly improved in both groups. All positive effects were evident four months following baseline assessment and could be still documented at 1.5-year follow-up. Mixed linear models showed that family functioning and parenting to a lesser extent were associated with the greatest changes in children's psychosocial outcomes in both interventions..
LIMITATIONS


The lack of data regarding parents that refused to receive the interventions may limit generalizability of results. A further limitation is the lack of a no-intervention control group.
CONCLUSIONS


The study offers a preliminary evidence base for integrating preventive interventions for child mental health in routine clinical practice with adult depressed patients.",2020,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","['families with parental depression', 'Thirty families of depressed patients', 'child mental health in routine clinical practice with adult depressed patients']","['Mental health promotion and prevention interventions', 'six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session']","[""parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems"", ""Child's prosocial behavior, perceived social support, and health-related quality of life""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",32.0,0.0624,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece. Electronic address: ggiannak@med.uoa.gr.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Solantaus', 'Affiliation': 'MIELI Mental Health Finland, Helsinki, Finland.'}, {'ForeName': 'Chara', 'Initials': 'C', 'LastName': 'Tzavara', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Kolaitis', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.070']
2412,32956964,Efficacy of learning through play plus intervention to reduce maternal depression in women with malnourished children: A randomized controlled trial from Pakistan ✰ .,"BACKGROUND


The risk factors and adverse outcomes related to maternal depression and child malnutrition are a leading cause of morbidity and mortality in low and middle-income countries (LMIC) including Pakistan. Above 25% of women suffer from maternal depression. Up to 50% children are under-nourished which contributes to 35% of all under-5 deaths in the country.
AIM


To determine the efficacy of Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention to reduce maternal depression in mothers with undernourished children.
METHODS


In this randomised controlled trial, all eligible mothers presenting to the paediatric departments were invited to participate in the study. Out of the total 256 mothers screened, 107 were included, 54 of those were randomly allocated to LTP Plus group and 53 to treatment as usual (TAU). Edinburgh Postnatal Depression Scale (EPDS) was used to screen for depression. Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D) were used to measure the severity of depression, mother-child attachment, level of support and health related quality of life dimensions. Assessments were completed at baseline, end of intervention (3 months from baseline) and at 6 months from baseline.
RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
CONCLUSION


The outcomes of LTP Plus intervention for mothers of malnourished children show promising results in reducing maternal depression and improving child outcomes. A full trial with longer-term outcomes and cost-effectiveness needs to be conducted.",2020,"RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","['Out of the total 256 mothers screened, 107 were included, 54 of those', 'mothers with undernourished children', 'eligible mothers presenting to the paediatric departments were invited to participate in the study', 'mothers of malnourished children', 'women with malnourished children']","['Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention', 'learning through play plus intervention', 'LTP Plus group and 53 to treatment as usual (TAU', 'LTP Plus intervention']","['Edinburgh Postnatal Depression Scale (EPDS', 'depression (p<0.001), social support', 'maternal depression', 'severity of depression, mother-child attachment, level of support and health related quality of life dimensions', 'maternal depression and improving child outcomes', 'quality of life', 'Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1533125', 'cui_str': 'Euro'}]",,0.148806,"RESULTS


Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","[{'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'University of Manchester United Kingdom; Lancashire Care NHS Foundation Trust. Electronic address: Nusrat.husain@manchester.ac.uk.'}, {'ForeName': 'Tayyeba', 'Initials': 'T', 'LastName': 'Kiran', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Lancashire Care NHS Foundation Trust; Pakistan Institute of Living and Learning.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'University of Liverpool United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Raza-Ur-Rehman', 'Affiliation': 'Dow University of Health Sciences.'}, {'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Saeed', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Shehla', 'Initials': 'S', 'LastName': 'Naeem', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sami Ul', 'Initials': 'SU', 'LastName': 'Haq', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Jaffery', 'Affiliation': 'Karachi Medical and Dental College Pakistan.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'Centre for Addiction & Mental Health, Toronto, Canada.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chaudhry', 'Affiliation': 'Pakistan Institute of Living and Learning.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.001']
2413,32957009,Meal skipping and cognition along a spectrum of restrictive eating.,"OBJECTIVE


Inadequate nutrition adversely impacts brain development and cognitive functioning (Pollitt et al., 1983). Studies examining the acute impact of eating regular meals on cognition have reported inconsistent findings, necessitating the exploration of individual differences in samples contributing to equivocal results. The present study examines the impact of skipping lunch on cognitive ability in college-aged students by including eating restraint as a moderator.
METHODS


Participants were 99 college-aged students (M = 19.7 years, SD = 1.5) randomized to a blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting, and eating disorder symptomology.
RESULTS


Regressing long and short-term memory on the lunch manipulation, eating restraint scores, and their interaction revealed significant interactions: those who had lunch had superior memory performance, but only for those reporting lower levels of eating restraint. Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
CONCLUSIONS


Results suggest that skipping lunch may have immediate consequences on cognition, however, cognitive enhancing effects may be diminished in the presence of even low levels of eating restraint. Findings highlight the significance of purported subclinical levels of eating restraint and may inform health education strategies.",2020,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","['college-aged students by including eating restraint as a moderator', 'Participants were 99 college-aged students (M\xa0=\xa019.7\xa0years, SD\xa0=\xa01.5) randomized to a']","['skipping lunch', ""blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting""]","['cognitive ability', 'superior memory performance', 'lunch manipulation, eating restraint scores']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0492838,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA. Electronic address: nandinid@stanford.edu.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Bidopia', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gaurie', 'Initials': 'G', 'LastName': 'Mittal', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Alphin', 'Affiliation': 'Duke University Department of Family Medicine and Community Health, Durham, NC, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Marsh', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gavan J', 'Initials': 'GJ', 'LastName': 'Fitzsimons', 'Affiliation': 'Duke University Fuqua School of Business, Durham, NC, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Strauman', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Zucker', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA; Duke University School of Medicine Department of Psychiatry & Behavioral Sciences, Durham, NC, USA.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101431']
2414,32957034,Landing biomechanics are not immediately altered by a single-dose patellar tendon isometric exercise protocol in male athletes with patellar tendinopathy: A single-blinded randomized cross-over trial.,"OBJECTIVES


To a) determine the acute effects of a single-dose patellar tendon isometric exercise protocol on involved limb landing biomechanics in individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy demonstrated changes in pain following a single-dose patellar tendon isometric exercise protocol.
DESIGN


Single-blinded randomized cross-over trial.
SETTING


Laboratory; PARTICIPANTS: 28 young male athletes with symptomatic (n = 13, age: 19.62 ± 1.61) and asymptomatic (n = 15, age: 21.13 ± 1.88) patellar tendinopathy.
MAIN OUTCOME MEASURES


Participants completed a single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol, randomized and separated by 7-10 days. Pain-levels during a single-limb decline squat (SLDS) and three-dimensional biomechanics were collected during a double-limb jump-landing task before and after each intervention protocol. A mixed-model repeated measures ANOVA was conducted to compare change scores for all dependent variables.
RESULTS


There were no group × intervention interactions for change in pain (F (1, 26)  = 0.555, p = 0.463). There was one significant group × intervention interaction for vertical ground reaction force (VGRF) (F (1, 26)  = 5.33, p = 0.029). However, post-hoc testing with Bonferroni correction demonstrated no statistical significance for group (SYM: t = -1.679, p = 0.119; ASYM: t = -1.7, p = 0.107) or intervention condition (isometric: t = -2.58, p = 0.016; sham-TENS: 0.72, p = 0.460). There were no further significant group × intervention interactions (p > 0.05).
CONCLUSIONS


A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.",2020,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"['individuals with patellar tendinopathy and asymptomatic patellar tendon pathology, and b) determine if individuals with patellar tendinopathy', '28 young male athletes with symptomatic (n\xa0=\xa013, age: 19.62\xa0±\xa01.61) and asymptomatic (n\xa0=\xa015, age: 21.13\xa0±\xa01.88) patellar tendinopathy', 'male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology', 'male athletes with patellar tendinopathy']","['sham-TENS', 'single-dose patellar tendon isometric exercise protocol', 'single-limb decline squat (SLDS', 'single-dose patellar tendon isometric exercise protocol and a sham-TENS protocol', 'patellar tendon isometric exercise protocol']","['Pain-levels', 'landing biomechanics or pain levels', 'vertical ground reaction force (VGRF', 'limb landing biomechanics', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191374', 'cui_str': '1.88'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",28.0,0.197403,A single-dose patellar tendon isometric exercise protocol did not have acute effects on landing biomechanics or pain levels in male athletes with patellar tendinopathy or asymptomatic patellar tendon pathology.,"[{'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Pietrosimone', 'Affiliation': 'Doctor of Physical Therapy Division, Department of Orthopedic Surgery, School of Medicine, Duke University, Durham, NC, USA. Electronic address: laura.pietrosimone@duke.edu.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Berkoff', 'Affiliation': 'Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sean I', 'Initials': 'SI', 'LastName': 'Docking', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Cook', 'Affiliation': 'La Trobe Sports and Exercise Research Centre, LaTrobe University, Bundooram, Australia.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Orthopedics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.09.003']
2415,32957077,Effect of Resistance-Training Programs Differing in Set Configuration on Maximal Strength and Explosive-Action Performance.,"PURPOSE


To compare the effects of 2 upper-body strength-training programs differing in set configuration on bench press 1-repetition maximum (BP1RM), bench press throw peak velocity against 30 kg (BPT30), and handball throwing velocity.
METHODS


Thirty-five men were randomly assigned to a traditional group (TRG; n = 12), rest redistribution group (RRG; n = 13), or control group (n = 10). The training program was conducted with the bench press exercise and lasted 6 weeks (2 sessions per week): TRG-6 sets × 5 repetitions with 3 minutes of interset rest; RRG-1 set × 30 repetitions with 31 seconds of interrepetition rest. The total rest period (15 min) and load intensity (75% 1RM) were the same for both experimental groups. Subjects performed all repetitions at maximal intended velocity, and the load was adjusted on a daily basis from velocity recordings.
RESULTS


A significant time × group interaction was observed for both BP1RM and BPT30 (P < .01) due to the higher values observed at posttest compared with pretest for TRG (effect size [ES] = 0.77) and RRG (ES = 0.56-0.59) but not for the control group (ES ≤ 0.08). The changes in BP1RM and BPT30 did not differ between TRG and RRG (ES = 0.04 and 0.05, respectively). No significant differences in handball throwing velocity were observed between the pretest and posttest (ES = 0.16, 0.22, and 0.02 for TRG, RRG, and control group, respectively).
CONCLUSIONS


Resistance-training programs based on not-to-failure traditional and rest redistribution set configurations induce similar changes in BP1RM, BPT30, and handball throwing velocity.",2020,A significant time × group interaction was observed for both BP1RM and BPT30 (P < .01) due to the higher values observed at posttest compared with pretest for TRG (effect size [ES] = 0.77) and RRG (ES = 0.56-0.59) but not for the control group (ES ≤ 0.08).,['Thirty-five men'],[],"['total rest period (15\xa0min) and load intensity', 'bench press 1-repetition maximum (BP1RM), bench press throw peak velocity against 30\xa0kg (BPT30), and handball throwing velocity', 'Maximal Strength and Explosive-Action Performance', 'BP1RM, BPT30, and handball throwing velocity', 'BP1RM and BPT30', 'handball throwing velocity']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0441472', 'cui_str': 'Action'}]",35.0,0.0279199,A significant time × group interaction was observed for both BP1RM and BPT30 (P < .01) due to the higher values observed at posttest compared with pretest for TRG (effect size [ES] = 0.77) and RRG (ES = 0.56-0.59) but not for the control group (ES ≤ 0.08).,"[{'ForeName': 'Jesualdo', 'Initials': 'J', 'LastName': 'Cuevas-Aburto', 'Affiliation': ''}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Jukic', 'Affiliation': ''}, {'ForeName': 'Jorge Miguel', 'Initials': 'JM', 'LastName': 'González-Hernández', 'Affiliation': ''}, {'ForeName': 'Danica', 'Initials': 'D', 'LastName': 'Janicijevic', 'Affiliation': ''}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Barboza-González', 'Affiliation': ''}, {'ForeName': 'Luis Javier', 'Initials': 'LJ', 'LastName': 'Chirosa-Ríos', 'Affiliation': ''}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-1005']
2416,32957331,Effect of sitting and lying Liuzijue for lung rehabilitation in acute exacerbation of chronic obstructive pulmonary disease patients with non-invasive ventilation: Study protocol for a randomized controlled trial.,"INTRODUCTION


Chronic obstructive pulmonary disease (COPD) is a lung disease with the highest incidence and high mortality in the world. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) can significantly accelerate the progression of the disease. Pulmonary rehabilitation is one of the effective treatment methods in COPD patients, but few studies have focused on the effect of pulmonary rehabilitation in AECOPD patients. Liuzijue can improve the pulmonary function and relieve symptoms of COPD patients. However, due to the influence of disease and non-invasive ventilation (NIV), AECOPD patients have poor compliance with getting out of bed at the early stage. Sitting and lying Liuzijue is more suitable in AECOPD patients with NIV. Therefore, this study will evaluate the effect of sitting and lying Liuzijue for lung function, exercise endurance, and quality of life in AEOPD patients with NIV.
METHODS


This study is a clinical randomized controlled trial. Sixty four AECOPD patients with NIV will be randomly divided into the experimental group and the control group. All participants will be treated with routine treatment and nursing according to their specific condition. The experimental group will be combined with sitting and lying Liuzijue on the basis of the control group. The duration of the exercise will be 3 months. The primary outcomes are the pulmonary function test and 6-minute walking test (6MWT). The secondary outcome measures include blood gas parameters, dyspnea index (the Modified Medical Research Council Dyspnea Scale [mMRC]), the body-mass, airflow obstruction, dyspnea and exercise capacity (BODE) index, anxiety, and depression (Hospital Anxiety and Depression Scale [HADS]), and quality of life (St·George Respiratory Questionnaire [SGRQ]). The measurement of outcomes will be evaluated at week 13.
DISCUSSION


It's imperative to focus on pulmonary rehabilitation in AECOPD patients. The purpose of this study is to evaluate the effect of sitting and lying Liuzijue for pulmonary rehabilitation in AECOPD patients with NIV.
TRIAL REGISTRATION


ChiCTR2000034530, Registered on July 8th, 2020.",2020,"The secondary outcome measures include blood gas parameters, dyspnea index (the Modified Medical Research Council Dyspnea Scale [mMRC]), the body-mass, airflow obstruction, dyspnea and exercise capacity (BODE) index, anxiety, and depression (Hospital Anxiety and Depression Scale [HADS]), and quality of life (St·George Respiratory Questionnaire [SGRQ]).","['COPD patients', 'chronic obstructive pulmonary disease patients with non-invasive ventilation', 'AECOPD patients with NIV', 'Sixty four AECOPD patients with NIV', 'AECOPD patients', 'AEOPD patients with NIV', 'chronic obstructive pulmonary disease (AECOPD']","['sitting and lying Liuzijue', 'Liuzijue']","['pulmonary function test and 6-minute walking test (6MWT', 'lung function, exercise endurance, and quality of life', 'pulmonary function', 'blood gas parameters, dyspnea index (the Modified Medical Research Council Dyspnea Scale [mMRC]), the body-mass, airflow obstruction, dyspnea and exercise capacity (BODE) index, anxiety, and depression (Hospital Anxiety and Depression Scale [HADS]), and quality of life (St·George Respiratory Questionnaire [SGRQ']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",64.0,0.0376081,"The secondary outcome measures include blood gas parameters, dyspnea index (the Modified Medical Research Council Dyspnea Scale [mMRC]), the body-mass, airflow obstruction, dyspnea and exercise capacity (BODE) index, anxiety, and depression (Hospital Anxiety and Depression Scale [HADS]), and quality of life (St·George Respiratory Questionnaire [SGRQ]).","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yi', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Rensong', 'Initials': 'R', 'LastName': 'Yue', 'Affiliation': 'Department of Endocrinology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, P.R. China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Ruolan', 'Initials': 'R', 'LastName': 'Ding', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jian', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qiurun', 'Initials': 'Q', 'LastName': 'Zhong', 'Affiliation': 'Nursing School, Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000022111']
2417,32957332,Effect of Shexiang Tongxin dropping pill on stable coronary artery disease patients with normal fractional flow reserve and coronary microvascular disease: A study protocol.,"INTRODUCTION


Coronary microvascular disease (CMVD) can affect the structure, function, and metabolism of the heart, and has an important impact on the occurrence, development and prognosis of coronary artery disease (CAD). Shexiang Tongxin dropping pill (STDP) can dilate blood vessels, alleviate inflammation, reduce endothelial damage, and improve coronary microvascular function in mice with myocardial infarction. This study aims to assess the impact of STDP on stable coronary artery disease (SCAD) patients with normal FFR and CMVD.
METHODS AND ANALYSIS


This is a single-center, prospective randomized trial that will enroll 64 SCAD patients, CAD with normal FFR and CMVD. Patients will be randomly divided into study group and control group in a 1:1 fashion. On the basis of conventional drug treatment, the former will receive STDP while the latter will not. The follow-up period of the subjects is 12 months, and clinical follow-up will be conducted before discharge, 30 days, 3 months, 6 months, and 12 months after procedure to complete the detection of relevant indicators. The primary endpoint is the change of index of microcirculatory resistance (ΔIMR) at 12-month follow-up.
DISCUSSION


The present study will be the first randomized control study to evaluate the efficacy and safety of STDP on SCAD patients, CAD with normal FFR and CMVD, which will provide a broader idea and more experimental basis for improving the treatment of CMVD.
TRIAL REGISTRATION


This is a protocol for the randomized clinical trial which has been registered in the Chinese clinical Trial Registry with an identifier: ChiCTR2000032429.",2020,"Shexiang Tongxin dropping pill (STDP) can dilate blood vessels, alleviate inflammation, reduce endothelial damage, and improve coronary microvascular function in mice with myocardial infarction.","['stable coronary artery disease patients with normal fractional flow reserve and coronary microvascular disease', 'mice with myocardial infarction', 'stable coronary artery disease (SCAD) patients with normal FFR and CMVD', '64 SCAD patients, CAD with normal FFR and CMVD']","['Shexiang Tongxin dropping pill (STDP', 'STDP', 'Shexiang Tongxin dropping pill']","['coronary microvascular function', 'efficacy and safety', 'change of index of microcirculatory resistance (ΔIMR']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0206064', 'cui_str': 'Cardiac syndrome X'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C4079279', 'cui_str': 'shexiang tongxin'}, {'cui': 'C0440421', 'cui_str': 'Droppings'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",64.0,0.0754199,"Shexiang Tongxin dropping pill (STDP) can dilate blood vessels, alleviate inflammation, reduce endothelial damage, and improve coronary microvascular function in mice with myocardial infarction.","[{'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, Key Laboratory of Cardiovascular Intervention and Regenerative Medicine of Zhejiang Province, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Xiaopeng', 'Initials': 'X', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'Jiefang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Chongying', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': ''}, {'ForeName': 'Junhui', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Guosheng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Fuyu', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022126']
2418,32957334,Effect of different form of upper limb muscles training on dyspnea in chronic obstructive pulmonary disease: A study protocol.,"INTRODUCTION


In activities involving upper limbs, patients with chronic obstructive pulmonary disease (COPD) report an increase in dyspnea. For this reason, the authors of the recommendations about pulmonary rehabilitation propose to perform upper limbs muscle strengthening in patients with COPD. However, the modalities of strengthening are not clearly established.The aim of this study is to compare the effects of upper limbs endurance strengthening versus upper limbs force strengthening, in patients with COPD during a pulmonary rehabilitation program.
METHODS


This study is a randomized, open-label, bi-center controlled trial in parallel groups distributed in a ratio (1:1) comparing upper limbs force strengthening (group F) to the upper limbs endurance strengthening (group E) during a pulmonary rehabilitation program in patients with COPD stages 2 to 4 (A-D).After randomization, patients will be allocated to follow: A 4 weeks pulmonary rehabilitation program with upper limbs resistance strengthening (group F). A 4 weeks pulmonary rehabilitation program with upper limbs endurance strengthening (group E).The primary outcome is dyspnea measured with the London Chest Activity of daily Living questionnaire. The secondary outcomes are dyspnea (using Modified Medical Research Council dyspnea Scale, dyspnea-12 questionnaire, multidimensional dyspnea profile questionnaire), upper limb exercise capacity (using the 6-minute Peg Board and Ring Test), Maximal voluntary strength of deltoid, biceps, and brachial triceps.The sample size calculated is 140 patients per group, or 280 in total.
DISCUSSION


The modalities of upper limb strengthening are not very well known, and evidence based is lacking to recommend endurance or resistance upper limb strengthening.We anticipate that the results of this study will be of relevance to clinical practice. They will bring information about the best modality of upper limb strengthening to use during a pulmonary rehabilitation program.
TRIAL REGISTRATION


IdRCB n°2018-A00955-50; V1.1 du 11/07/2018; REHABSUP, clinical trial.gov (NCT03611036), registered August 02, 2018, https://clinicaltrials.gov/ct2/show/NCT03611036.",2020,A 4 weeks pulmonary rehabilitation program with upper limbs endurance strengthening (group E).The primary outcome is dyspnea measured with the London Chest Activity of daily Living questionnaire.,"['patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'chronic obstructive pulmonary disease', '140 patients per group, or 280 in total', 'patients with COPD during a pulmonary rehabilitation program']","['pulmonary rehabilitation program with upper limbs resistance strengthening (group F', 'pulmonary rehabilitation program with upper limbs endurance strengthening', 'upper limb muscles training', 'upper limbs force strengthening (group F) to the upper limbs endurance strengthening (group E) during a pulmonary rehabilitation program', 'upper limbs endurance strengthening versus upper limbs force strengthening']","['dyspnea', 'dyspnea (using Modified Medical Research Council dyspnea Scale, dyspnea-12 questionnaire, multidimensional dyspnea profile questionnaire), upper limb exercise capacity (using the 6-minute Peg Board and Ring Test), Maximal voluntary strength of deltoid, biceps, and brachial triceps', 'dyspnea measured with the London Chest Activity of daily Living questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441839', 'cui_str': 'Group E'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0454320', 'cui_str': 'Upper limb exercises'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0769542,A 4 weeks pulmonary rehabilitation program with upper limbs endurance strengthening (group E).The primary outcome is dyspnea measured with the London Chest Activity of daily Living questionnaire.,"[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, Morlaix.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Péran', 'Affiliation': 'Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, Morlaix.'}, {'ForeName': 'Anne Cécile', 'Initials': 'AC', 'LastName': 'Berriet', 'Affiliation': 'Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, Morlaix.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Le Ber', 'Affiliation': 'Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, Morlaix.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Le Mevel', 'Affiliation': 'Pulmonary Rehabilitation Unit, Morlaix Hospital Centre, Morlaix.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Courtois-Communier', 'Affiliation': ""INSERM Centre d'Investigation Clinique 1412, University Hospital of Brest.""}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Department of Internal Medicine and Chest Diseases, EA3878 (GETBO), CIC INSERM 1412, University Hospital of Brest, European University of Occidental Brittany, Brest, France.'}]",Medicine,['10.1097/MD.0000000000022131']
2419,32957336,The prolongation effect of ilaprazole-based standard triple therapy for Helicobacter pylori.,"BACKGROUND


Helicobacter pylori (HP) infection causes many diseases, such as peptic ulcers, gastritis and gastric cancer, and MALToma. It has been gradually accepted that all HP-infected patients should be treated because HP is regarded as an infection. Therefore, the importance of selecting the optimal treatment regimen has increased. Although the 14-day standard triple therapy (STT) is recommended in the current guidelines, prolonging treatment duration is controversial in real practice because of inconsistent results from previous data and the risk of adverse effects. Additionally, the effect of STT using ilaprazole has not been reported until now. We aimed to compare the eradication rate between 7 and 10 days STT using ilaprazole.
METHODS


A prospective randomized controlled trial was conducted, which was divided into 2 treatment groups: the control group was 7 days of STT, and the test group was 10 days of STT. The eradication regimen was 10 mg ilaprazole, 500 mg clarithromycin, and 1000 mg amoxicillin twice daily. We included patients who were diagnosed with positive results of H pylori examination. We compared the HP eradication rate according to treatment duration, CYP2C19 subtype and endoscopic diagnosis.
RESULTS


We enrolled a total of 254 patients consisting of 127 patients in each treatment arm. The eradication rates of the control and test groups were 65.4% (82/127) and 74.8% (95/127), respectively, in the intention-to-treat analysis (P = .1). In the per-protocol analysis, 70.3% (83/118) and 82.6% (94/115) were eradicated in each group, which was statistically significant (P = .027). The CYP2C19 subtype was examined in 230 patients. The eradication rate was 79.2% (57/72), 75.4% (92/122), and 72.2% (26/36) in each group, which was not significantly different (P = .704).
CONCLUSION


Ten-day STT was more effective than 7-day STT for HP eradication. The eradication rate was not affected by the CYP2C19 genotype.",2020,"The eradication rate was 79.2% (57/72), 75.4% (92/122), and 72.2% (26/36) in each group, which was not significantly different (","['Helicobacter pylori', '254 patients consisting of 127 patients in each treatment arm', 'patients who were diagnosed with positive results of H pylori examination', '230 patients']","['14-day standard triple therapy (STT', 'clarithromycin', 'amoxicillin', 'ilaprazole-based standard triple therapy']","['eradication rates', 'eradication rate', 'HP eradication rate']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1881129', 'cui_str': 'ilaprazole'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",254.0,0.0711825,"The eradication rate was 79.2% (57/72), 75.4% (92/122), and 72.2% (26/36) in each group, which was not significantly different (","[{'ForeName': 'Seung Woo', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul.'}, {'ForeName': 'Sung Jin', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul.'}, {'ForeName': 'Sae Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Eulji University.'}, {'ForeName': 'Sung Hee', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Eulji University.'}, {'ForeName': 'Kyung Ho', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Konyang University.'}, {'ForeName': 'Sun Moon', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, College of Medicine, Konyang University.'}, {'ForeName': 'Jae Kyu', 'Initials': 'JK', 'LastName': 'Sung', 'Affiliation': 'Division of Gastroenterology Department of Internal Medicine, Chungnam National University School of Medicine, Republic of Korea.'}, {'ForeName': 'Dong Soo', 'Initials': 'DS', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul.'}]",Medicine,['10.1097/MD.0000000000022137']
2420,32957397,Preoperative nursing visit reduces preoperative anxiety and postoperative complications in patients with laparoscopic cholecystectomy: A randomized clinical trial protocol.,"BACKGROUND


Anxiety is a kind of emotional disorder caused by acute conditions or trigger. It is manifested in the components of the autonomic nervous system, for instance, stress, anxiety, nervosity, and discomfort. Most patients with anxiety are more active, nervous, and alert to various stimuli. Inappropriate management of early postoperative anxiety will not only prolong recovery but also increase the risk of other complications. We conduct a randomized clinical trial to investigate the influences of nursing visits against the preoperative anxiety and postoperative complications in patients undergoing laparoscopic cholecystectomy (LC).
METHODS


This is a single center, placebo-controlled randomized trial, which will be performed from August 2020 to December 2020. The trial is performed in accordance with the SPIRIT Checklist for randomized studies. It is authorized by the Ethics Committee of Taizhou Hospital of Zhejiang Province (D20211-34). Two hundred patients undergoing LC will be included in this study. Patients are randomly divided into 2 groups: experiential group (n = 100) or control group (n = 100). The experimental group is given preoperative nursing visit to each patient 1 day before the operation, whereas the control group did not receive the preoperative nursing intervention. The patients in experience group also received education on the surgery team and the environment of operating room, the process of anesthesia, advantages of laparoscopic surgery, and the postoperative care from recovery room to discharge. The primary outcomes include State-Trait anxiety level and postoperative visual analogue scale. Secondary outcomes include total consumption of analgesics and postoperative complications.
RESULTS


Figure (a) will show the comparison of outcomes between 2 groups.
CONCLUSION


The preoperative nursing visit may decrease the anxiety and the complications after operation in patients receiving LC.
TRIAL REGISTRATION


This study protocol is registered in Research Registry (researchregistry5924).",2020,The primary outcomes include State-Trait anxiety level and postoperative visual analogue scale.,"['patients undergoing laparoscopic cholecystectomy (LC', 'patients with laparoscopic cholecystectomy', 'August 2020 to December 2020', 'Two hundred patients undergoing LC', 'patients receiving LC']","['Preoperative nursing visit', 'nursing visits', 'control group did not receive the preoperative nursing intervention', 'experiential group (n\u200a=\u200a100) or control group', 'placebo']","['total consumption of analgesics and postoperative complications', 'State-Trait anxiety level and postoperative visual analogue scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",200.0,0.0585976,The primary outcomes include State-Trait anxiety level and postoperative visual analogue scale.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Vascular surgical hernia and abdominal surgery, Taizhou Hospital of Zhejiang Province, Zhejiang, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022314']
2421,32957403,"Safety and efficacy of a self-developed Chinese pelvic repair system and Avaulta repair system for the treatment of pelvic organ prolapse in women: A multicenter, prospective, randomized, parallel-group study.","The pelvic organ prolapse (POP) repair systems used in China are imported and expensive. Our aim was to compare the efficacy and safety of a self-developed pelvic floor repair system versus the Avaulta system.This was a multicenter, randomized, parallel-group, noninferiority trial of 132 patients with POP stage ≥II from the Tongji Hospital Affiliated to Tongji University and the General Hospital of Ningxia Medical University enrolled from 02/2014 to 03/2015. The patients were randomized 1:1 to POP repair using the self-developed system or the Avaulta system. Perioperative conditions, POP quantification, pelvic floor impact questionnaire-7, and prolapse quality of life questionnaires, gynecological ultrasound, and postoperative complications were compared. Patients were followed at 1.5, 3, and 6 months.According to the POP quantification scores obtained at 6 months after surgery, the cure rates of the self-developed and Avaulta groups were 98.3% and 100.0%, respectively (P > .999). At 6 months follow-up, the pelvic floor impact questionnaire-7 scores of the self-developed and Avaulta groups were both improved (P < .001 vs baseline), with no between-group difference observed (P = .488). There were no differences between the 2 groups for subjective symptoms of POP (all P > .05). There were no significant differences between the 2 groups regarding complications (all P > .05).The self-developed pelvic reconstruction system is safe and effective for the treatment of POP and improves the patients' quality of life, without difference compared to the Avaulta system.",2020,"self-developed pelvic reconstruction system is safe and effective for the treatment of POP and improves the patients' quality of life, without difference compared to the Avaulta system.","['pelvic organ prolapse in women', '132 patients with POP stage ≥II from the Tongji Hospital Affiliated to Tongji University and the General Hospital of Ningxia Medical University enrolled from 02/2014 to 03/2015']","['POP repair using the self-developed system or the Avaulta system', 'self-developed pelvic floor repair system versus the Avaulta system', 'self-developed Chinese pelvic repair system and Avaulta repair system']","['Safety and efficacy', 'efficacy and safety', 'Perioperative conditions, POP quantification, pelvic floor impact questionnaire-7, and prolapse quality of life questionnaires, gynecological ultrasound, and postoperative complications', 'pelvic floor impact questionnaire-7 scores', 'POP quantification scores', 'subjective symptoms of POP', 'complications', 'cure rates']","[{'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0198782', 'cui_str': 'Reconstruction of pelvic floor'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1293218', 'cui_str': 'Pelvis repair'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",132.0,0.0472483,"self-developed pelvic reconstruction system is safe and effective for the treatment of POP and improves the patients' quality of life, without difference compared to the Avaulta system.","[{'ForeName': 'Yiqin', 'Initials': 'Y', 'LastName': 'Ouyang', 'Affiliation': 'Department of Gynecology and Obstetrics, Tongji Hospital of Tongji University.'}, {'ForeName': 'Rujun', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': ""The Fifth People's Hospital of Shanghai, Shanghai.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chu', 'Affiliation': 'Department of Gynecology and Obstetrics, Tongji Hospital of Tongji University.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Gynecology and Obstetrics, Tongji Hospital of Tongji University.'}, {'ForeName': 'Xueyu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Gynecology and Obstetrics, Tongji Hospital of Tongji University.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Gao', 'Affiliation': 'Department of Gynecology and Obstetrics, Tongji Hospital of Tongji University.'}, {'ForeName': 'Huaifang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Gynecology and Obstetrics, Tongji Hospital of Tongji University.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': 'Department of Gynecology and Obstetrics, Tongji Hospital of Tongji University.'}]",Medicine,['10.1097/MD.0000000000022332']
2422,32957406,Psychological nursing intervention reduces psychological distress in patients with thyroid cancer: A randomized clinical trial protocol.,"BACKGROUND


Thyroidectomy has been considered an effective method to treat thyroid cancer. However, about 20% of patients have psychological distress before surgery. Psychological distress is considered common mental illnesses and it has been reported that the patients who suffer psychological distress have poor clinical outcomes than the patients without psychosocial disorder. Therefore, we design this randomized controlled study to explore the effect of psychological nursing intervention against quality of life and psychological distress of the patients with thyroid cancer.
METHOD


The trial will be conducted from September 2020 to December 2020 at Wuhan Fourth Hospital on the basis of the International Council for Harmonisation's Good Clinical Practice Guidelines and the principles of the Helsinki Declaration. The study was authorized via the Research Ethics Committee of the Wuhan Fourth Hospital (Approval number: 20200721-046). This study is a single-center, randomized, 2-arm, evaluator-blinded clinical trial. In all, 90 patients with thyroid cancer undergoing thyroidectomy will be enrolled in this study. The inclusion criteria includes: patients aged between 20 and 60 years old; ASA I-II classification; normal platelet coagulation and count function. The exclusion criteria contains: people with the intellectual and cognitive impairment (behavioral-cognitive intervention); BMI above 35 kg/m; the history of renal and hepatic dysfunction; and patients refuse to participate in this study. Both the patients in psychological intervention group and control group should receive the routine care, while the psychological intervention group also needs to receive the additional proper psychological nursing interventions. The emotional disorders are detected with the Chinese version of Profile of Mood States-Brief. And the patients' life quality is evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questionnaire (QLQ-C30, version 3.0). All the data are collated into Microsoft Excel 2010 and analyzed with SPSS 12.0 (IBM).
RESULTS


It is assumed that psychological nursing intervention could alleviate the psychological distress of patients with thyroid cancer and improve their quality of life.
CONCLUSION


This study can provide the reliable evidence regarding the influence of psychological nursing intervention against the life quality and psychological distress of the patients with thyroid cancer.
TRIAL REGISTRATION


This study protocol is registered in Research Registry (researchregistry5937).",2020,"It is assumed that psychological nursing intervention could alleviate the psychological distress of patients with thyroid cancer and improve their quality of life.
","['patients who suffer psychological distress', 'exclusion criteria contains: people with the intellectual and cognitive impairment (behavioral-cognitive intervention); BMI above 35\u200akg/m', ""September 2020 to December 2020 at Wuhan Fourth Hospital on the basis of the International Council for Harmonisation's Good Clinical Practice Guidelines and the principles of the Helsinki Declaration"", '90 patients with thyroid cancer undergoing', ' patients aged between 20 and 60 years old; ASA I-II classification; normal platelet coagulation and count function', 'patients with thyroid cancer']","['Psychological nursing intervention', 'thyroidectomy', 'psychological nursing intervention', 'psychological intervention', 'routine care, while the psychological intervention group also needs to receive the additional proper psychological nursing interventions']","['psychological distress', 'quality of life and psychological distress', 'Cancer Quality of Life Questionnaire-Core Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282451', 'cui_str': 'Clinical Practice Guideline'}, {'cui': 'C0018898', 'cui_str': 'Declaration of Helsinki'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}]",90.0,0.0636757,"It is assumed that psychological nursing intervention could alleviate the psychological distress of patients with thyroid cancer and improve their quality of life.
","[{'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Pain, Wuhan Fourth Hospital, Hubei, China.'}, {'ForeName': 'Yigang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022346']
2423,32957414,"The efficacy and safety of hachimijiogan for mild Alzheimer disease in an exploratory, open standard treatment controlled, randomized allocation, multicenter trial: A study protocol.","BACKGROUND


Dementia among the Japanese aged 65 years or over population is estimated to approach about 700 million cases by 2025, and a corresponding rapid increase in Alzheimer disease (AD) can also be expected. The ballooning number of dementia patients, including AD, is creating major medical and social challenges. At present, only 3 drugs are recognized for the treatment of mild AD, and these are only used to alleviate symptoms. Although new therapies are needed to treat mild AD, insufficient development of disease-modifying drugs is being done.
METHODS/DESIGN


The aim of this exploratory, open standard, treatment-controlled, randomized allocation, multicenter trial is to determine the efficacy of the traditional Japanese Kampo medicine hachimijiogan (HJG) on the cognitive dysfunction of mild AD.Eighty-six patients with AD diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 and as mild AD according to the Mini Mental State Examination (MMSE ≥21) will be included. All will already have been taking the same dose of Donepezil, Galantamine, or Rivastigmine for more than 3 months. The patients will be randomly assigned to receive additional treatment with HJG or to continue mild AD treatment without additional HJG. The primary endpoint is the change from baseline of the Alzheimer's Disease Assessment Scale-cognitive component- Japanese version (ADAS-Jcog). ADAS-Jcog is a useful index for detecting change over time that investigates memory and visuospatial cognition injury from the early stage. The secondary endpoints are the changes from baseline of the Instrumental Activity of Daily Life, Apathy scale, and Nueropsychiatric Inventory scores. In this protocol, we will examine the Geriatric depression scale and do Metabolome analysis as exploratory endpoints. The recruitment period will be from August 2019 to July 2021.
DISCUSSION


This is the first trial of Kampo medicine designed to examine the efficacy of HJG for the cognitive dysfunction of patients with mild AD.
TRIAL REGISTRATION


This trial was registered on the Japan Registry of Clinical trials on 2 August 2, 2019 (jRCTs 071190018).",2020,"This is the first trial of Kampo medicine designed to examine the efficacy of HJG for the cognitive dysfunction of patients with mild AD.
","['Dementia among the Japanese aged 65 years or over population', 'patients with mild AD', 'Japan Registry of Clinical trials on 2 August 2, 2019 (jRCTs 071190018', 'mild AD.Eighty-six patients with AD diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 and as mild AD according to the Mini Mental State Examination (MMSE ≥21']","['hachimijiogan', 'traditional Japanese Kampo medicine hachimijiogan (HJG', 'HJG or to continue mild AD treatment without additional HJG', 'HJG', 'Donepezil, Galantamine, or Rivastigmine']","['efficacy and safety', ""change from baseline of the Alzheimer's Disease Assessment Scale-cognitive component- Japanese version (ADAS-Jcog"", 'Geriatric depression scale', 'Instrumental Activity of Daily Life, Apathy scale, and Nueropsychiatric Inventory scores']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}]","[{'cui': 'C0062075', 'cui_str': 'hachimijiogan'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0752221', 'cui_str': 'Kampo Medicine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0649350', 'cui_str': 'rivastigmine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.131464,"This is the first trial of Kampo medicine designed to examine the efficacy of HJG for the cognitive dysfunction of patients with mild AD.
","[{'ForeName': 'Mosaburo', 'Initials': 'M', 'LastName': 'Kainuma', 'Affiliation': 'Community Medicine Education Unit, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kouta', 'Initials': 'K', 'LastName': 'Funakoshi', 'Affiliation': 'Department of Clinical Research Promotion, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ouma', 'Affiliation': 'Department of Neurology, School of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Ken-Ichiro', 'Initials': 'KI', 'LastName': 'Yamashita', 'Affiliation': 'Department of Clinical Neurophysiology, Faculty of Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ohara', 'Affiliation': 'Department of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Aoi', 'Initials': 'A', 'LastName': 'Yoshiiwa', 'Affiliation': 'Department of General Medicine, Oita University, Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Murata', 'Affiliation': 'Department of General Internal Medicine, Kyushu University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, School of Medicine, Fukuoka University, Fukuoka, Japan.'}]",Medicine,['10.1097/MD.0000000000022370']
2424,32965226,Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents' intrinsic motivation. The neurofeedback element reinforces relaxation abilities.
OBJECTIVE


This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care.
METHODS


This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters.
RESULTS


The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021.
CONCLUSIONS


Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents.
TRIAL REGISTRATION


Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19881.",2020,"This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems.","['a sample of traumatized adolescents in residential care', 'Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms', 'Traumatized Adolescents']","['Game-Based Meditation Therapy', 'game-based meditation therapy', 'Muse (InteraXon Inc', 'Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control']","['posttraumatic symptoms (self-report and mentor report) and stress (self-report', 'neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest', 'all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters', 'psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression', 'posttraumatic stress and neurobiological stress systems']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2366566', 'cui_str': 'Muse'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",,0.102227,"This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems.","[{'ForeName': 'Angela A T', 'Initials': 'AAT', 'LastName': 'Schuurmans', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Nijhof', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Scholte', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, Netherlands.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Popma', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Vrije Universiteit medisch centrum De Bascule, Amsterdam, Netherlands.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Otten', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, Netherlands.'}]",JMIR research protocols,['10.2196/19881']
2425,32965227,Optimizing an Acceptance and Commitment Therapy Microintervention Via a Mobile App With Two Cohorts: Protocol for Micro-Randomized Trials.,"BACKGROUND


Given gaps in the treatment of mental health, brief adaptive interventions have become a public health imperative. Transdiagnostic interventions may be particularly appropriate given high rates of medical comorbidity and the broader reach of transdiagnostic therapies. One such approach utilized herein is acceptance and commitment therapy (ACT), which is focused on increasing engagement with values, awareness, and openness to internal experiences. ACT theory posits that experiential avoidance is at the center of human suffering, regardless of diagnosis, and, as such, seeks to reduce unworkable experiential avoidance.
OBJECTIVE


Our objective is to provide the rationale and protocol for examining the safety, feasibility, and effectiveness of optimizing an ACT-based intervention via a mobile app among two disparate samples, which differ in sociodemographic characteristics and symptom profiles.
METHODS


Twice each day, participants are prompted via a mobile app to complete assessments of mood and activity and are then randomly assigned to an ACT-based intervention or not. These interventions are questions regarding engagement with values, awareness, and openness to internal experiences. Participant responses are recorded. Analyses will examine completion of assessments, change in symptoms from baseline assessment, and proximal change in mood and activity. A primary outcome of interest is proximal change in activity (eg, form and function of behavior and energy consumed by avoidance and values-based behavior) following interventions as a function of time, symptoms, and behavior, where we hypothesize that participants will focus more energy on values-based behaviors. Analyses will be conducted using a weighted and centered least squares approach. Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50).
RESULTS


Recruitment began on September 10, 2019, for the bipolar sample and on October 5, 2019, for the college sample. Participation in the study began on October 18, 2019.
CONCLUSIONS


This study examines an ACT-based intervention among two disparate samples. Should ACT demonstrate feasibility and preliminary effectiveness in each sample, a large randomized controlled trial applying ACT across diagnoses and demographics would be indicated. The public health implications of such an approach may be far-reaching.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04098497; https://clinicaltrials.gov/ct2/show/NCT04098497; ClinicalTrials.gov NCT04081662; https://clinicaltrials.gov/ct2/show/NCT04081662.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17086.",2020,"Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50).
",['sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50'],['ACT-based intervention or not'],"['proximal change in activity (eg, form and function of behavior and energy consumed by avoidance and values-based behavior) following interventions as a function of time, symptoms, and behavior']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2.0,0.264177,"Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50).
","[{'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Kroska', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Hoel', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Victory', 'Affiliation': 'Department of Psychiatry, University of Michigan-Ann Arbor, Ann Arbor, MI, United States.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': 'Department of Statistics, Harvard University, Cambridge, MA, United States.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan-Ann Arbor, Ann Arbor, MI, United States.'}, {'ForeName': 'Zachary N', 'Initials': 'ZN', 'LastName': 'Stowe', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cochran', 'Affiliation': 'Department of Population Health Sciences, University of Wisconsin-Madison, Madison, WI, United States.'}]",JMIR research protocols,['10.2196/17086']
2426,32965230,Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial.,"BACKGROUND


Research has underscored the need to develop socioculturally tailored interventions to improve adherence behaviors in minority patients with hypertension (HTN) and type 2 diabetes (T2D). Novel mobile health (mHealth) approaches are potential methods for delivering tailored interventions to minority patients with increased cardiovascular risk.
OBJECTIVE


This study aims to develop and evaluate the acceptability and preliminary efficacy of a tailored mHealth adherence intervention versus attention control (AC) on medication adherence, systolic blood pressure (SBP), diastolic blood pressure (DBP), and hemoglobin A 1c  (HbA 1c ) at 3 months in 42 Black patients with uncontrolled HTN and/or T2D who were initially nonadherent to their medications.
METHODS


This was a two-phase pilot study consisting of a formative phase and a clinical efficacy phase. The formative phase consisted of qualitative interviews with 10 members of the target patient population (7/10, 70% female; mean age 65.8 years, SD 5.6) to tailor the intervention based on the Information-Motivation-Behavioral skills model of adherence. The clinical efficacy phase consisted of a 3-month pilot randomized controlled trial to evaluate the tailored mHealth intervention versus an AC. The tablet-delivered intervention included a tailoring survey, an individualized adherence profile, and a personalized list of interactive adherence-promoting modules, whereas AC included the tailoring survey and health education videos delivered on the tablet. Acceptability was assessed through semistructured exit interviews. Medication adherence was assessed using the 8-item Morisky Medication Adherence Scale, whereas blood pressure and HbA 1c  were assessed using automated devices.
RESULTS


In phase 1, thematic analysis of the semistructured interviews revealed the following 5 major barriers to adherence: disruptions in daily routine, forgetfulness, concerns about adverse effects, preference for natural remedies, and burdens of medication taking. Patients recommended the inclusion of modules that address improving patient-provider communication, peer vignettes, and stress reduction strategies to facilitate adherence. A total of 42 Black patients (23/42, 55% male; mean age 57.6 years, SD 11.1) participated in the clinical efficacy pilot trial. At 3 months, both groups showed significant improvements in adherence (mean 1.35, SD 1.60; P<.001) and SBP (-4.76 mm Hg; P=.04) with no between-group differences (P=.50 and P=.10). The decreases in DBP and HbA 1c  over time were nonsignificant (-1.97 mm Hg; P=.20; and -0.2%; P=.45, respectively). Patients reported high acceptability of the intervention for improving their adherence.
CONCLUSIONS


This pilot study demonstrated preliminary evidence on the acceptability of a tailored mHealth adherence intervention among a sample of Black patients with uncontrolled HTN and T2D who were initially nonadherent to their medications. Future research should explore whether repeated opportunities to use the mHealth intervention would result in improvements in behavioral and clinical outcomes over time. Modifications to the intervention as a result of the pilot study should guide future efforts.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01643473; http://clinicaltrials.gov/ct2/show/ NCT01643473.",2020,The decreases in DBP and HbA 1c  over time were nonsignificant,"['minority patients with increased cardiovascular risk', '42 Black patients (23/42, 55% male; mean age 57.6 years, SD 11.1) participated in the clinical efficacy pilot trial', 'Black patients with uncontrolled HTN and T2D who were initially nonadherent to their medications', 'minority patients with hypertension (HTN) and type 2 diabetes (T2D', '10 members of the target patient population (7/10, 70% female; mean age 65.8 years, SD 5.6) to tailor the intervention based on the Information-Motivation-Behavioral skills model of adherence', '42 Black patients with uncontrolled HTN', 'Black Patients With Uncontrolled Hypertension and Type 2']","['tailored mHealth adherence intervention versus attention control (AC', 'tailored mHealth adherence intervention', 'Tailored Mobile Health Intervention', 'tailored mHealth intervention']","['adherence behaviors', 'medication adherence, systolic blood pressure (SBP), diastolic blood pressure (DBP), and hemoglobin A 1c  (HbA 1c ', 'Medication adherence', 'adverse effects, preference for natural remedies, and burdens of medication taking', '8-item Morisky Medication Adherence Scale', 'adherence', 'blood pressure and HbA 1c', 'DBP and HbA 1c  over time', 'Acceptability', 'Medication Adherence', 'SBP']","[{'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0516638', 'cui_str': 'Self-initiated health seeking behavior'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",42.0,0.0574425,The decreases in DBP and HbA 1c  over time were nonsignificant,"[{'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Schoenthaler', 'Affiliation': 'Department of Population Health, NYU school of Medicine, Center for Healthful Behavior Change, NYU Langone Health, New York, NY, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Leon', 'Affiliation': 'Department of Clinical Psychology, Fordham University, New York, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Center for Personalized Health, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, United States.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Steinhaeuser', 'Affiliation': 'Radiant Point Technologies, Inc., Honolulu, HI, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wardzinski', 'Affiliation': 'Radiant Point Technologies, Inc., Honolulu, HI, United States.'}]",JMIR mHealth and uHealth,['10.2196/17135']
2427,32965237,Telomerase Activation to Reverse Immunosenescence in Elderly Patients With Acute Coronary Syndrome: Protocol for a Randomized Pilot Trial.,"BACKGROUND


Inflammation plays a key role in the pathophysiology of coronary heart disease (CHD) and its acute manifestation, acute coronary syndrome (ACS). Aging is associated with a decline of the immune system, a process known as immunosenescence. This is characterized by an increase in highly proinflammatory T cells that are involved in CHD progression, plaque destabilization, and myocardial ischemia-reperfusion injury. Telomere dysfunction has been implicated in immunosenescence of T lymphocytes. Telomerase is the enzyme responsible for maintaining telomeres during cell divisions. It has a protective effect on cells under oxidative stress and helps regulate flow-mediated dilation in microvasculature.
OBJECTIVE


The TACTIC (Telomerase ACTivator to reverse Immunosenescence in Acute Coronary Syndrome) trial will investigate whether a telomerase activator, TA-65MD, can reduce the proportion of senescent T cells in patients with ACS with confirmed CHD. It will also assess the effect of TA-65MD on decreasing telomere shortening, reducing oxidative stress, and improving endothelial function.
METHODS


The study was designed as a single-center, randomized, double-blind, parallel-group, placebo-controlled phase II trial. Recruitment started in January 2019. A total of 90 patients, aged 65 years or older, with treated ACS who have had CHD confirmed by angiography will be enrolled. They will be randomized to one of two groups: TA-65MD oral therapy (8 mg twice daily) or placebo taken for 12 months. The primary outcome is the effect on immunosenescence determined by a decrease in the proportion of CD8+ TEMRA (T effector memory cells re-expressing CD45RA [CD45 expressing exon A]) cells at 12 months. Secondary outcomes include leukocyte telomere length, endothelial function, cardiac function as measured by echocardiography and NT-proBNP (N-terminal fragment of the prohormone brain-type natriuretic peptide), systemic inflammation, oxidative stress, and telomerase activity.
RESULTS


The study received National Health Service (NHS) ethics approval on August 9, 2018; Medicines and Healthcare products Regulatory Agency approval on October 19, 2018; and NHS Health Research Authority approval on October 22, 2018. The trial began recruiting participants in January 2019 and completed recruitment in March 2020; the trial is due to report results in 2021.
CONCLUSIONS


This pilot trial in older patients with CHD will explore outcomes not previously investigated outside in vitro or preclinical models. The robust design ensures that bias has been minimized. Should the results indicate reduced frequency of immunosenescent CD8+ T cells as well as improvements in telomere length and endothelial function, we will plan a larger, multicenter trial in patients to determine if TA-65MD is beneficial in the treatment of CHD in elderly patients.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN16613292; http://www.isrctn.com/ISRCTN16613292 and European Union Drug Regulating Authorities Clinical Trials Database (EudraCT), European Union Clinical Trials Register 2017-002876-26; https://tinyurl.com/y4m2so8g.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19456.",2020,The primary outcome is the effect on immunosenescence determined by a decrease in the proportion of CD8+ TEMRA (T effector memory cells re-expressing CD45RA [CD45 expressing exon A]) cells at 12 months.,"['older patients with CHD', 'Elderly Patients With Acute Coronary Syndrome', '90 patients, aged 65 years or older, with treated ACS who have had CHD confirmed by angiography will be enrolled', 'elderly patients', 'patients with ACS with confirmed CHD']","['placebo', 'TA-65MD', 'TA-65MD oral therapy']","['proportion of CD8+ TEMRA (T effector memory cells re-expressing CD45RA [CD45 expressing exon A]) cells', 'leukocyte telomere length, endothelial function, cardiac function as measured by echocardiography and NT-proBNP']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0312737', 'cui_str': 'Immunologic cell'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0108789', 'cui_str': 'Lymphocyte antigen CD45RA'}, {'cui': 'C0054961', 'cui_str': 'Lymphocyte antigen CD45'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",90.0,0.503371,The primary outcome is the effect on immunosenescence determined by a decrease in the proportion of CD8+ TEMRA (T effector memory cells re-expressing CD45RA [CD45 expressing exon A]) cells at 12 months.,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Bawamia', 'Affiliation': 'James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Bennaceur', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dunn', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Marsay', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Amoah', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Adetayo', 'Initials': 'A', 'LastName': 'Kasim', 'Affiliation': 'Wolfson Research Institute for Health and Wellbeing, Durham University, Durham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Filby', 'Affiliation': 'Flow Cytometry Core Facility, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Austin', 'Affiliation': 'James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hancock', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Ioakim', 'Initials': 'I', 'LastName': 'Spyridopoulos', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle Upon Tyne, United Kingdom.'}]",JMIR research protocols,['10.2196/19456']
2428,32965464,Effect of Escalating and Deescalating Financial Incentives vs Usual Care to Improve Antidepressant Adherence: A Pilot Randomized Clinical Trial.,,2020,,[],['Escalating and Deescalating Financial Incentives vs Usual Care'],['Antidepressant Adherence'],[],"[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0686583,,"[{'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Marcus', 'Affiliation': 'University of Pennsylvania School of Social Policy and Practice, Philadelphia.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Reilly', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Zentgraf', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Olfson', 'Affiliation': 'Department of Psychiatry, Columbia University, New York, New York.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.3000']
2429,32965471,Mindfulness Improves Brain-Computer Interface Performance by Increasing Control Over Neural Activity in the Alpha Band.,"Brain-computer interfaces (BCIs) are promising tools for assisting patients with paralysis, but suffer from long training times and variable user proficiency. Mind-body awareness training (MBAT) can improve BCI learning, but how it does so remains unknown. Here, we show that MBAT allows participants to learn to volitionally increase alpha band neural activity during BCI tasks that incorporate intentional rest. We trained individuals in mindfulness-based stress reduction (MBSR; a standardized MBAT intervention) and compared performance and brain activity before and after training between randomly assigned trained and untrained control groups. The MBAT group showed reliably faster learning of BCI than the control group throughout training. Alpha-band activity in electroencephalogram signals, recorded in the volitional resting state during task performance, showed a parallel increase over sessions, and predicted final BCI performance. The level of alpha-band activity during the intentional resting state correlated reliably with individuals' mindfulness practice as well as performance on a breath counting task. Collectively, these results show that MBAT modifies a specific neural signal used by BCI. MBAT, by increasing patients' control over their brain activity during rest, may increase the effectiveness of BCI in the large population who could benefit from alternatives to direct motor control.",2020,"Here, we show that MBAT allows participants to learn to volitionally increase alpha band neural activity during BCI tasks that incorporate intentional rest.",[],"['Mind-body awareness training (MBAT', 'mindfulness-based stress reduction (MBSR; a standardized MBAT intervention', 'Brain-computer interfaces (BCIs', 'MBAT']","['final BCI performance', 'level of alpha-band activity', 'learning of BCI', 'Mindfulness Improves Brain-Computer Interface Performance']",[],"[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}]",,0.0128676,"Here, we show that MBAT allows participants to learn to volitionally increase alpha band neural activity during BCI tasks that incorporate intentional rest.","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Stieger', 'Affiliation': 'Department of Biomedical Engineering, Carnegie Mellon University, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Engel', 'Affiliation': 'Department of Psychology, University of Minnesota, Minneapolis, MN 55414, USA.'}, {'ForeName': 'Haiteng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Biomedical Engineering, Carnegie Mellon University, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Cline', 'Affiliation': 'Department of Biomedical Engineering, University of Minnesota, Minneapolis, MN 55414, USA.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Kreitzer', 'Affiliation': 'Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, Minneapolis, MN 55414, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Department of Biomedical Engineering, Carnegie Mellon University, Pittsburgh, PA 15213, USA.'}]","Cerebral cortex (New York, N.Y. : 1991)",['10.1093/cercor/bhaa234']
2430,32965476,Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial.,"Importance


Adding clopidogrel to aspirin for 3 months after transcatheter atrial septal defect (ASD) closure results in a lower incidence of new-onset migraine attacks. However, the outcomes at 6- to 12-month follow-up (after clopidogrel cessation at 3 months) remain largely unknown.
Objective


To assess the incidence of migraine attacks at 6- and 12-month follow-up after transcatheter ASD closure.
Design, Setting, and Participants


This prespecified analysis of a randomized, double-blind clinical trial included patients with no prior history of migraine undergoing ASD closure from 6 university hospitals in Canada from December 2008 to November 2014. Patients were followed up at 3, 6, and 12 months, and a migraine headache questionnaire was administered at each time. Analysis began June 2019.
Interventions


Patients were randomized (1:1) to receive dual antiplatelet therapy (aspirin plus clopidogrel; n = 84) vs single antiplatelet therapy (aspirin plus placebo; n = 87) for 3 months following transcatheter ASD closure. After 3 months, only single antiplatelet therapy (aspirin) was pursued.
Main Outcomes and Measures


Incidence and severity of migraine attacks at 6- and 12-month follow-up.
Results


The mean (SD) age of the study population was 38 (12) years, with 106 women (62%). A total of 27 patients (15.8%) had new-onset migraine attacks within the 3 months following ASD closure (8 of 84 [9.5%] vs 19 of 87 [21.8%] in the initial clopidogrel and placebo groups, respectively; P = .03). After cessation of clopidogrel and aspirin monotherapy, the percentage of patients with migraine attacks decreased over time, with 8 (4.7%) and 4 patients (2.3%) continuing to have migraine attacks at 6 and 12 months, respectively (vs 3 months: P < .001). The severity of migraine attacks progressively decreased over time; no moderate or severe attacks occurred at 6 and 12 months (vs 3 months: P < .001). There were no differences between groups in the rate of migraine attacks at 6 months (initial clopidogrel group: 2 of 84 [2.4%]; initial placebo group: 6 of 87 [6.9%]; P = .28) and 12 months (initial clopidogrel group: 3 of 84 [3.6%]; initial placebo group: 1 of 87 [1.1%]; P = .36) after ASD closure. Only 2 patients (1.2%; 1 patient per group) presented with new-onset migraine attacks after 3 months.
Conclusions and Relevance


New-onset migraine attacks after ASD closure improved or resolved spontaneously within 6 to 12 months in most patients. No significant rebound effect was observed after clopidogrel cessation at 3 months. These results demonstrate a low rate of migraine events beyond 3 months following transcatheter ASD closure and support the early discontinuation of clopidogrel therapy if administered.
Trial Registration


ClinicalTrials.gov Identifier: NCT00799045.",2020,There were no differences between groups in the rate of migraine attacks at 6 months (initial clopidogrel group: 2 of 84 [2.4%]; initial placebo group: 6 of 87 [6.9%]; P = .28) and 12 months (initial clopidogrel group: 3 of 84 [3.6%]; initial placebo group: 1 of 87 [1.1%]; P = .36) after ASD closure.,"['The mean (SD) age of the study population was 38 (12) years, with 106 women (62', 'patients with no prior history of migraine undergoing ASD closure from 6 university hospitals in Canada from December 2008 to November 2014']","['transcatheter ASD closure', 'Transcatheter Atrial Septal Defect Closure', 'clopidogrel and aspirin monotherapy', 'dual antiplatelet therapy (aspirin plus clopidogrel; n\u2009=\u200984) vs single antiplatelet therapy (aspirin plus placebo', 'Clopidogrel and Aspirin vs Aspirin Alone', 'clopidogrel to aspirin', 'antiplatelet therapy (aspirin']","['incidence of migraine attacks', 'Measures\n\n\nIncidence and severity of migraine attacks', 'migraine attacks', 'migraine headache questionnaire', 'Migraine Headaches', 'new-onset migraine attacks', 'severity of migraine attacks', 'rate of migraine attacks', 'moderate or severe attacks']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0455512', 'cui_str': 'H/O: migraine'}, {'cui': 'C0189965', 'cui_str': 'Atrioseptoplasty'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0189965', 'cui_str': 'Atrioseptoplasty'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",27.0,0.125546,There were no differences between groups in the rate of migraine attacks at 6 months (initial clopidogrel group: 2 of 84 [2.4%]; initial placebo group: 6 of 87 [6.9%]; P = .28) and 12 months (initial clopidogrel group: 3 of 84 [3.6%]; initial placebo group: 1 of 87 [1.1%]; P = .36) after ASD closure.,"[{'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Wintzer-Wehekind', 'Affiliation': 'Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Horlick', 'Affiliation': 'Department of Cardiology, Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Cardiology, Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Asim N', 'Initials': 'AN', 'LastName': 'Cheema', 'Affiliation': ""Department of Cardiology, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Labinaz', 'Affiliation': 'Department of Cardiology, Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Najaf', 'Initials': 'N', 'LastName': 'Nadeem', 'Affiliation': 'Department of Cardiology, Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Osten', 'Affiliation': 'Department of Cardiology, Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Côté', 'Affiliation': 'Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'Josep Ramon', 'Initials': 'JR', 'LastName': 'Marsal', 'Affiliation': ""Epidemiology Unit of the Cardiology Department, Vall d'Hebron Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Rivest', 'Affiliation': 'Department of Neurology, Hôtel Dieu de Lévis, Quebec City, Quebec, Canada.'}, {'ForeName': 'Alier', 'Initials': 'A', 'LastName': 'Marrero', 'Affiliation': 'Department of Neurology, Centre Hospitalier Universitaire Georges L. Dumont, Moncton, New Brunswick, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Houde', 'Affiliation': 'Department of Pediatric Cardiology, Centre Hospitalier Universitaire de Québec, Quebec City, Quebec, Canada.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Rodés-Cabau', 'Affiliation': 'Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada.'}]",JAMA cardiology,['10.1001/jamacardio.2020.4297']
2431,32965493,Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous Ulceration: A Randomized Clinical Trial.,"Importance


One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux.
Objective


To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration.
Design, Setting, and Participants


Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months' duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019.
Interventions


Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team.
Main Outcomes and Measures


The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness.
Results


The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year.
Conclusions and Relevance


Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence.
Trial Registration


ClinicalTrials.gov identifier: ISRCTN02335796.",2020,"Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002).","['A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence', 'Venous Ulceration', '226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92', '224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92', '6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others', 'patients with venous leg ulceration', 'participants who are treated with early endovenous ablation of lower extremity superficial reflux', ""Participants\n\n\nBetween October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months' duration and superficial venous reflux""]","['compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n\u2009=\u2009224) or compression with deferred endovenous treatment of superficial venous reflux', 'early endovenous ablation of superficial venous reflux', 'Early Endovenous Ablation']","['cost-effective', 'time to first ulcer recurrence', 'ulcer recurrence rate and cost-effectiveness', 'Time to ulcer healing', 'Ulcers', 'healing of venous leg ulcers', 'overall incidence of ulcer recurrence']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0587532', 'cui_str': 'Vascular surgery department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0333293', 'cui_str': 'Healing ulcer'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2242647', 'cui_str': 'Endovenous ablation'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2242647', 'cui_str': 'Endovenous ablation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0333293', 'cui_str': 'Healing ulcer'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",450.0,0.105144,"Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002).","[{'ForeName': 'Manjit S', 'Initials': 'MS', 'LastName': 'Gohel', 'Affiliation': 'Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Mora MSc', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Szigeti', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Epstein', 'Affiliation': 'Department of Applied Economics, University of Granada, Granada, Spain.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Heatley', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bulbulia', 'Affiliation': 'Gloucestershire Hospitals National Health Service Foundation Trust, Cheltenham, United Kingdom.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Cullum', 'Affiliation': 'University of Manchester & Manchester University National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Nyamekye', 'Affiliation': 'Worcestershire Acute Hospitals National Health Service Trust, Worcestershire, United Kingdom.'}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Poskitt', 'Affiliation': 'Gloucestershire Hospitals National Health Service Foundation Trust, Cheltenham, United Kingdom.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renton', 'Affiliation': 'North West London Hospitals National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Alun H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2020.3845']
2432,32965495,"Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults With Molluscum Contagiosum: Two Phase 3 Randomized Clinical Trials.","Importance


Molluscum contagiosum (MC) is a common viral skin infection that primarily affects children. Cantharidin, a topical vesicant, has a long history of use for MC in compounded formulations, but the safety and efficacy of doses, regimens, and application methods have not been demonstrated in large-scale trials.
Objective


To determine the safety and efficacy of VP-102, a drug-device combination containing cantharidin, 0.7% (w/v), compared with vehicle in individuals with MC.
Design, Setting, and Participants


Two phase 3, randomized, double-blind, vehicle-controlled trials of identical design (Cantharidin Application in Molluscum Patients [CAMP-1 and CAMP-2]) were conducted in 31 centers across the US. A total of 528 individuals aged 2 years or older with MC participated. CAMP-1 was conducted from March 21 to November 26, 2018, and CAMP-2 was conducted from February 14 to September 26, 2018.
Interventions


Participants were randomized (3:2) to topical application of VP-102 or vehicle to all treatable lesions every 21 days until complete lesion clearance or up to 4 treatments.
Main Outcomes and Measures


The primary efficacy outcome was the proportion of VP-102-treated participants achieving complete clearance of all MC lesions (baseline and new) compared with those who received the vehicle at the end-of-study visit on day 84. Intent-to-treat analysis was conducted for the efficacy population. Secondary efficacy outcomes included the proportion of participants achieving complete clearance of lesions at days 21, 42, and 63. Safety outcomes included assessment of adverse events, including expected local skin reactions.
Results


Of the 528 participants enrolled, 527 received treatment (CAMP-1, n = 265; CAMP-2, n = 262). A total of 267 of 527 participants (50.7%) were male; mean (SD) ages for CAMP-1 and CAMP-2 were 7.5 (5.3) years and 7.4 (8.0) years for the VP-102 groups and 6.3 (4.7) years and 7.3 (6.7) years for the vehicle groups. Treatment with VP-102 demonstrated superior efficacy to vehicle in the percentage of participants with complete clearance of MC lesions at the end of the study visit for CAMP-1 (VP-102: 46.3% vs vehicle: 17.9%; P < .001) and CAMP-2 (VP-102: 54.0% vs vehicle: 13.4%; P < .001). Adverse events were observed in 99% (CAMP-1) and 95% (CAMP-2) of VP-102-treated participants and 73% (CAMP-1) and 66% (CAMP-2) of vehicle-treated participants. The most common adverse events included application site vesicles, pain, pruritus, erythema, and scab. Most adverse events were mild or moderate in severity.
Conclusions and Relevance


In the 2 phase 3 trials reported herein, VP-102 was statistically significantly superior to vehicle in achieving complete clearance of MC lesions at the end of the study visit in both trials, with adverse events that were generally mild to moderate and confined to application sites. These findings show that VP-102 is potentially an effective and safe treatment for MC, a common skin condition with no US Food and Drug Administration-approved treatments.
Trial Registrations


ClinicalTrials.gov Identifiers: NCT03377790 and NCT03377803.",2020,"The most common adverse events included application site vesicles, pain, pruritus, erythema, and scab.","['528 participants enrolled', 'Children and Adults With Molluscum Contagiosum', 'Molluscum Patients [CAMP-1 and CAMP-2]) were conducted in 31 centers across the US', '528 individuals aged 2 years or older with MC participated', 'individuals with MC.\nDesign, Setting, and Participants', 'A total of 267 of 527 participants (50.7%) were male; mean (SD) ages for CAMP-1 and CAMP-2 were 7.5 (5.3) years and 7.4 (8.0) years for the VP-102 groups and 6.3 (4.7) years and 7.3 (6.7) years for the vehicle groups']","['VP-102', 'topical application of VP-102 or vehicle to all treatable lesions every 21 days until complete lesion clearance or up to 4 treatments', 'Importance\n\n\nMolluscum contagiosum (MC']","['Adverse events', 'adverse events, including expected local skin reactions', 'complete clearance of MC lesions', 'proportion of participants achieving complete clearance of lesions', 'proportion of VP-102-treated participants achieving complete clearance of all MC lesions (baseline and new', 'application site vesicles, pain, pruritus, erythema, and scab']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026393', 'cui_str': 'Molluscum contagiosum infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3873150', 'cui_str': 'Every twenty one days'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026393', 'cui_str': 'Molluscum contagiosum infection'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0026393', 'cui_str': 'Molluscum contagiosum infection'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0877097', 'cui_str': 'Application site vesicles'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0074125', 'cui_str': 'SCAB protocol'}]",528.0,0.392585,"The most common adverse events included application site vesicles, pain, pruritus, erythema, and scab.","[{'ForeName': 'Lawrence F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': 'School of Medicine, University of California, San Diego.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'McFalda', 'Affiliation': 'Clarkston Skin Research, Clarkston, Michigan.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Brabec', 'Affiliation': ""Midwest Children's Health Research Institute, Lincoln, Nebraska.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Siegfried', 'Affiliation': 'Department of Pediatrics, St Louis University, St Louis, Missouri.'}, {'ForeName': 'Pearl', 'Initials': 'P', 'LastName': 'Kwong', 'Affiliation': 'Solutions Through Advanced Research, Jacksonville, Florida.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McBride', 'Affiliation': 'Instat Consulting, Inc, Chatham, New Jersey.'}, {'ForeName': 'Jayson', 'Initials': 'J', 'LastName': 'Rieger', 'Affiliation': 'Verrica Pharmaceuticals Inc, West Chester, Pennsylvania.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Willson', 'Affiliation': 'Verrica Pharmaceuticals Inc, West Chester, Pennsylvania.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Verrica Pharmaceuticals Inc, West Chester, Pennsylvania.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Burnett', 'Affiliation': 'Verrica Pharmaceuticals Inc, West Chester, Pennsylvania.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.3238']
2433,32965593,"Transcranial random noise stimulation over the primary motor cortex in PD-MCI patients: a crossover, randomized, sham-controlled study.","Mild cognitive impairment (MCI) is a very common non-motor feature of Parkinson's disease (PD) and the non-amnestic single-domain is the most frequent subtype. Transcranial random noise stimulation (tRNS) is a non-invasive technique, which is capable of enhancing cortical excitability. As the main contributor to voluntary movement control, the primary motor cortex (M1) has been recently reported to be involved in higher cognitive functioning. The aim of this study is to evaluate the effects of tRNS applied over M1 in PD-MCI patients in cognitive and motor tasks. Ten PD-MCI patients, diagnosed according to the Movement Disorder Society, Level II criteria for MCI, underwent active (real) and placebo (sham) tRNS single sessions, at least 1 week apart. Patients underwent cognitive (Digit Span Forward and Backward, Digit Symbol, Visual Search, Letter Fluency, Stroop Test) and motor assessments (Unified Parkinson's Disease Rating Scale [UPDRS-ME], specific timed trials for bradykinesia, 10-m walk and Timed up and go tests) before and after each session. A significant improvement in motor ability (UPDRS-ME and lateralized scores, ps from 0.049 to 0.003) was observed after real versus sham tRNS. On the contrary, no significant differences were found in other motor tasks and cognitive assessment both after real and sham stimulations. These results confirm that tRNS is a safe and effective tool for improving motor functioning in PD-MCI. Future studies using a multisession tRNS applied over multitargeted brain areas (i.e., dorsolateral prefrontal cortex and M1) are required to clarify the role of tRNS regarding rehabilitative intervention in PD.",2020,"On the contrary, no significant differences were found in other motor tasks and cognitive assessment both after real and sham stimulations.","['PD-MCI patients', 'PD-MCI patients in cognitive and motor tasks']","['tRNS', 'placebo', 'Transcranial random noise stimulation', 'Transcranial random noise stimulation (tRNS']","['motor ability (UPDRS-ME and lateralized scores', 'motor tasks and cognitive assessment', 'Mild cognitive impairment (MCI', ""cognitive (Digit Span Forward and Backward, Digit Symbol, Visual Search, Letter Fluency, Stroop Test) and motor assessments (Unified Parkinson's Disease Rating Scale [UPDRS-ME], specific timed trials for bradykinesia, 10-m walk and Timed up and go tests""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0271377,"On the contrary, no significant differences were found in other motor tasks and cognitive assessment both after real and sham stimulations.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Monastero', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Via La Loggia 1, 90129, Palermo, Italy. roberto.monastero@unipa.it.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Baschi', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Via La Loggia 1, 90129, Palermo, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Nicoletti', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pilati', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Via La Loggia 1, 90129, Palermo, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Pagano', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Via La Loggia 1, 90129, Palermo, Italy.'}, {'ForeName': 'Calogero Edoardo', 'Initials': 'CE', 'LastName': 'Cicero', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zappia', 'Affiliation': 'Department of Medical and Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", Section of Neurosciences, University of Catania, Catania, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Brighina', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics, University of Palermo, Via La Loggia 1, 90129, Palermo, Italy.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-020-02255-2']
2434,32965602,Correction to: Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis.,This article originally published with the family name and given names of all authors transposed.,2020,This article originally published with the family name and given names of all authors transposed.,['subjects with moderate-to-severe rheumatoid arthritis'],['biosimilar ABP 798 with rituximab reference product'],[],"[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",[],,0.233974,This article originally published with the family name and given names of all authors transposed.,"[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Burmester', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Free University and Humboldt University Berlin, Charité University Medicine Berlin, Charitéplatz 1, 10117, Berlin, Germany. gerd.burmester@charite.de.'}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Drescher', 'Affiliation': 'Veszprém Csolnoky Ferenc County Hospital, Veszprém, Hungary.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Hrycaj', 'Affiliation': 'Rheumatology, Koscian Municipal Hospital, Koscian, Poland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Metroplex Clinical Research Center, Dallas, TX, USA.'}]",Clinical rheumatology,['10.1007/s10067-020-05410-y']
2435,32965617,Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials.,"BACKGROUND


The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases. However, a subgroup analysis of Crohn's disease (CD) in the main trial displayed a close to significant difference favouring originator infliximab, and more scientific data have therefore been requested.
OBJECTIVE


The aim was to assess treatment efficacy, safety, and immunogenicity in an explorative subgroup analysis in CD and ulcerative colitis (UC) in the NOR-SWITCH trials.
PATIENTS AND METHODS


The 52-week, randomised, non-inferiority, double-blind, multicentre, phase 4 NOR-SWITCH study was followed by a 26-week open extension trial where all patients received treatment with CT-P13. Treatment efficacy, safety, and immunogenicity in CD and UC were assessed throughout the 78-week study period.
RESULTS


The main and extension trials included 155 and 93 patients with CD and 93 and 80 patients with UC, respectively. Demographic and baseline characteristics were comparable in both treatment arms within patient groups. There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC. Moreover, comparable results were also demonstrated for trough serum levels, presence of anti-drug antibodies, and reported adverse events.
CONCLUSION


Efficacy, safety, and immunogenicity of both the originator and biosimilar infliximab were comparable in CD and UC in the NOR-SWITCH main and extension trials. These explorative subgroup analyses confirm that there are no significant concerns related to switching from originator infliximab to CT-P13 in CD and UC.
TRIAL REGISTRATION


ClinicalTrials.gov, number NCT02148640.",2020,"There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC.","['155 and 93 patients with CD and 93 and 80 patients with UC, respectively']","['originator and biosimilar infliximab', 'CT-P13']","['treatment efficacy, safety, and immunogenicity', 'Efficacy, safety, and immunogenicity', ""activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC"", 'Treatment efficacy, safety, and immunogenicity in CD and UC', 'trough serum levels, presence of anti-drug antibodies, and reported adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C3884615', 'cui_str': 'CT-P13'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.241068,"There were no differences in the main and extension trials regarding changes in activity indices, C-reactive protein, faecal calprotectin, patient's and physician's global assessment of disease activity and patient-reported outcome measures in CD and UC.","[{'ForeName': 'Kristin K', 'Initials': 'KK', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Gastroenterology, Akershus University Hospital, Sykehusveien 75, 1478, Lørenskog, Norway. kristin.kaasen.jorgensen@ahus.no.'}, {'ForeName': 'Guro L', 'Initials': 'GL', 'LastName': 'Goll', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Sexton', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Bolstad', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway.'}, {'ForeName': 'Inge C', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Research Support Services CTU, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Asak', 'Affiliation': 'Department of Gastroenterology, Gjøvik Hospital, Gjøvik, Norway.'}, {'ForeName': 'Ingrid P', 'Initials': 'IP', 'LastName': 'Berset', 'Affiliation': 'Department of Gastroenterology, Ålesund Hospital, Ålesund, Norway.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Blomgren', 'Affiliation': 'Department of Gastroenterology, Haugesund Hospital, Haugesund, Norway.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Dvergsnes', 'Affiliation': 'Department of Gastroenterology, Sørlandet Hospital, Kristiansand, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Florholmen', 'Affiliation': 'Department of Gastroenterology, University Hospital North Norway, Tromsø, Norway.'}, {'ForeName': 'Svein O', 'Initials': 'SO', 'LastName': 'Frigstad', 'Affiliation': 'Department of Medicine, Vestre Viken Bærum Hospital, Gjettum, Norway.'}, {'ForeName': 'Magne', 'Initials': 'M', 'LastName': 'Henriksen', 'Affiliation': 'Department of Gastroenterology, Østfold Hospital, Fredrikstad, Norway.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hagfors', 'Affiliation': 'Patient Representative, Landsforeningen for Fordøyelsessykdommer, Oslo, Norway.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Huppertz-Hauss', 'Affiliation': 'Department of Gastroenterology, Telemark Hospital, Skien, Norway.'}, {'ForeName': 'Espen A', 'Initials': 'EA', 'LastName': 'Haavardsholm', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Rolf A', 'Initials': 'RA', 'LastName': 'Klaasen', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Moum', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Noraberg', 'Affiliation': 'Department of Gastroenterology, Sørlandet Hospital, Arendal, Norway.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Prestegård', 'Affiliation': 'Department of Gastroenterology, Lillehammer Hospital, Lillehammer, Norway.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Rydning', 'Affiliation': 'Department of Gastroenterology, Akershus University Hospital, Sykehusveien 75, 1478, Lørenskog, Norway.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Sagatun', 'Affiliation': ""Department of Gastroenterology, Sankt Olav's Hospital, Trondheim, Norway.""}, {'ForeName': 'Kathrine A', 'Initials': 'KA', 'LastName': 'Seeberg', 'Affiliation': 'Department of Gastroenterology, Vestfold Hospital, Tønsberg, Norway.'}, {'ForeName': 'Roald', 'Initials': 'R', 'LastName': 'Torp', 'Affiliation': 'Department of Gastroenterology, Hamar Hospital, Hamar, Norway.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Vold', 'Affiliation': 'Department of Gastroenterology, Bodø Hospital, Bodø, Norway.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Warren', 'Affiliation': 'Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Ystrøm', 'Affiliation': 'Department of Gastroenterology, Elverum Hospital, Elverum, Norway.'}, {'ForeName': 'Knut E A', 'Initials': 'KEA', 'LastName': 'Lundin', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Kvien', 'Affiliation': 'Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Jahnsen', 'Affiliation': 'Department of Gastroenterology, Akershus University Hospital, Sykehusveien 75, 1478, Lørenskog, Norway.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00438-7']
2436,32965622,"Evaluation of the efficacy of sexual intercourse on distal ureteral stones in women: a prospective, randomized, controlled study.","AIM


To evaluate the efficacy of sexual intercourse in the expulsion of distal ureteric stones in women.
MATERIALS AND METHODS


A total of seventy woman patients with distal ureteral or intramural stone were randomly divided into two groups. Group 1 included 35 patients who were advised to do sexual intercourse 3-4 times/week with the administration of symptomatic treatment, and group 2 (control group) included 35 patients receiving symptomatic treatment only and were instructed not to do sexual intercourse or masturbation during the study. After 4 weeks follow up; the expulsion rate, need for analgesic and ureterorenoscopic lithotripsy were compared for each group.
RESULTS


The mean ages of the patients in groups 1 and 2 were 36.4 ± 10.8, 37.1 ± 12.4, respectively. The mean stone size was 7.01 ± 1.6 in group 1, 6.67 ± 1.4 mm in group 2 (p: 0.3). Stone expulsion rate, in the first 2 weeks for group 1 was 80% (28/35), while 51.4% (18/35) in group 2 (p < 0.001). In the 4th week, the expulsion rate for group 1 was 85.7%, but 60% in group 2 (p < 0.001). The mean expulsion time was shorter in group 1 (12 ± 4.2 days) than group 2 (16.1 ± 6.4 days) (p < 0.01). The analgesic needs in groups 1 and 2 were found to be 1.9 ± 0.7, 2.6 ± 0.8 times/a day respectively, and were significantly lower in group 1 (p < 0.001).
CONCLUSION


At least three or four sexual intercourses per week seem to increase the spontaneous passage for distal or intramural ureteral stones in women. Furthermore, sexual intercourse reduces the need for analgesics.",2020,The mean expulsion time was shorter in group 1 (12 ± 4.2 days) than group 2 (16.1 ± 6.4 days) (p < 0.01).,"['women', 'seventy woman patients with distal ureteral or intramural stone', '35 patients who were advised to do sexual intercourse 3-4\xa0times/week with the administration of symptomatic treatment, and group 2 (control group) included 35 patients receiving symptomatic treatment only and were instructed not to do sexual intercourse or masturbation during the study']",['sexual intercourse'],"['mean expulsion time', 'Stone expulsion rate', 'spontaneous passage for distal or intramural ureteral stones', 'expulsion rate', 'distal ureteral stones', 'expulsion rate, need for analgesic and ureterorenoscopic lithotripsy', 'analgesic needs', 'mean stone size']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024906', 'cui_str': 'Masturbation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}]",70.0,0.0309914,The mean expulsion time was shorter in group 1 (12 ± 4.2 days) than group 2 (16.1 ± 6.4 days) (p < 0.01).,"[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Turgut', 'Affiliation': 'Faculty of Health Science, Avrasya University, Trabzon, Turkey. drhasanturgut@hotmail.com.'}]",International urology and nephrology,['10.1007/s11255-020-02661-1']
2437,32957418,"Effects of electroacupuncture therapy for depression: Study protocol for a multicentered, randomized controlled trial.","INTRODUCTION


As a major public health problem, depression has a negative impact on individuals and society. The aim of this well-designed trial is to evaluate the efficacy and safety of electroacupuncture (EA) treatment for depression.
METHODS/DESIGN


A 3-arm parallel, nonblinded, randomized controlled trial will be performed in 4 hospitals (centers). A total of 144 participants will be divided into 3 groups: EA group, manual acupuncture (MA) group, and western medicine group. Participants in EA group and MA group will receive 12 sessions of acupuncture treatment for 4 weeks. Participants allocated to western medicine group will only take 20 mg fluoxetine orally per day for 4 weeks. The primary outcome is Hamilton Depression Scale. Secondary outcomes are Self-Rating Depression Scale, Depression Scale of traditional Chinese medicine (Depression Scale of Traditional Chinese Medicine), brain fMRI and blood biomarkers including neurotransmitters serotonin, dopamine, noradrenaline, inflammatory cytokines inerleukin (IL)-1β, tumor necrosis factor-α, IL-6, and neurotrophin BDNF. All the outcomes will be assessed at baseline, 4 weeks after EA treatment onset and 6-month follow-up.
DISCUSSION


The results of this trial will verify the efficacy and safety of EA treatment for depressive patients and provide acupuncturists and clinicians with robust clinical evidence.
TRIAL REGISTRATION


Chinese Clinical Trial Registry identifier: ChiCTR1900023420. Version 1. Registered on 26 May 2019. http://www.chictr.org.cn/edit.aspx?pid=37621&htm=4.",2020,"The results of this trial will verify the efficacy and safety of EA treatment for depressive patients and provide acupuncturists and clinicians with robust clinical evidence.
","['depressive patients and provide acupuncturists and clinicians with robust clinical evidence', '4 hospitals (centers', '144 participants']","['EA', 'manual acupuncture (MA) group, and western medicine group', 'fluoxetine', 'acupuncture', 'electroacupuncture therapy', 'electroacupuncture (EA']","['efficacy and safety', 'Hamilton Depression Scale', 'Self-Rating Depression Scale, Depression Scale of traditional Chinese medicine (Depression Scale of Traditional Chinese Medicine), brain fMRI and blood biomarkers including neurotransmitters serotonin, dopamine, noradrenaline, inflammatory cytokines inerleukin (IL)-1β, tumor necrosis factor-α, IL-6, and neurotrophin BDNF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1556023', 'cui_str': 'Acupuncturist'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}]",144.0,0.170361,"The results of this trial will verify the efficacy and safety of EA treatment for depressive patients and provide acupuncturists and clinicians with robust clinical evidence.
","[{'ForeName': 'Wa', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Institute of Acupuncture and Anesthesia.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Institute of Acupuncture and Anesthesia.'}, {'ForeName': 'Ai-Wen', 'Initials': 'AW', 'LastName': 'Chen', 'Affiliation': 'Institute of Acupuncture and Anesthesia.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Shen', 'Affiliation': 'Institute of Acupuncture and Anesthesia.'}]",Medicine,['10.1097/MD.0000000000022380']
2438,32957420,"Short and medium-term effects of a multicomponent physical exercise program with a Mediterranean diet on bone mineral density, gait, balance, and fall risk for patients with Alzheimer disease: Randomized controlled clinical trial study protocol.","INTRODUCTION


Reduced bone mineral density and increased risk of falls are related with Alzheimer disease, and these increase likelihood of bone osteoporotic fractures causing serious complications such as disability, fear of falling, loss autonomy, decreased quality of life, and anticipated mortality in elderly patients. Gait and balance disturb are 2 factors to favor falls in elderly, and in patients with cognitive impairment, the risk of falls increases to double. Exercise and Mediterranean diet produce beneficial effects for aging, cognitive decline, and are widely recommended to reduce the effects of osteoporosis, fall risk, and related fragility fractures. The primary objective of this study is to evaluate the short and medium-term effects during 6 months, of a multicomponent physical exercise program with a Mediterranean diet on bone mineral density, fall risk, balance, and gait by a controlled clinical trial in patients with Alzheimer disease.
METHODS


The study is a 6-month, randomized controlled parallel-group, single-blinded clinical trial. Institutionalized patients with Alzheimer disease will be included. The intervention group will perform a multicomponent physical exercise program in reduced groups, with a frequency of 3 sessions per week, associated with a Mediterranean diet. This program includes strength, balance, and aerobic resistance exercises, and in the main part of the session, also ludic exercises to improve agility, coordination, and balance. The control group will receive usual care. The outcomes to assess are the change of physical functions, such as gait and balance, and the change of bone mineral density by calcaneal quantitative ultrasound, during the study follow-up at 1, 3, and 6 months. This clinical trial will generate more and new evidence on the effects of a multicomponent physical exercise program and Mediterranean diet in patients with Alzheimer disease on risk of falls and osteoporotic fractures, the relation of these with bone mineral density, gait and balance, and the correlations between them.
ETHICS AND DISSEMINATION


This study protocol has been approved by the Ethics Committee of the University of Salamanca. The results will be published in peer-reviewed journals and disseminated in national and international conferences, to the participants and their families, and the general public through the associations of people with AD.
TRIAL REGISTRATION ID


ClínicalTrials.gov ID: NCT04439097.",2020,"Exercise and Mediterranean diet produce beneficial effects for aging, cognitive decline, and are widely recommended to reduce the effects of osteoporosis, fall risk, and related fragility fractures.","['Institutionalized patients with Alzheimer disease', 'patients with Alzheimer disease on risk of falls and osteoporotic fractures', 'patients with Alzheimer disease', 'elderly patients']","['multicomponent physical exercise program with a Mediterranean diet', 'multicomponent physical exercise program and Mediterranean diet', 'Exercise and Mediterranean diet', 'multicomponent physical exercise program']","['change of physical functions, such as gait and balance, and the change of bone mineral density', 'bone mineral density, gait, balance, and fall risk', 'bone mineral density, fall risk, balance, and gait', 'agility, coordination, and balance']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",,0.0434416,"Exercise and Mediterranean diet produce beneficial effects for aging, cognitive decline, and are widely recommended to reduce the effects of osteoporosis, fall risk, and related fragility fractures.","[{'ForeName': 'Ana Silvia', 'Initials': 'AS', 'LastName': 'Puente-González', 'Affiliation': 'Department of Nursing and Physical Therapy. University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Sánchez-González', 'Affiliation': 'Department of Nursing and Physical Therapy. University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Juan Elicio', 'Initials': 'JE', 'LastName': 'Hernández-Xumet', 'Affiliation': 'Department of Physical Medicine and Pharmacology, University of La Laguna, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'María Carmen', 'Initials': 'MC', 'LastName': 'Sánchez-Sánchez', 'Affiliation': 'Department of Nursing and Physical Therapy. University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Fausto José', 'Initials': 'FJ', 'LastName': 'Barbero-Iglesias', 'Affiliation': 'Department of Nursing and Physical Therapy. University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Méndez-Sánchez', 'Affiliation': 'Department of Nursing and Physical Therapy. University of Salamanca, Salamanca, Spain.'}]",Medicine,['10.1097/MD.0000000000022385']
2439,32957482,"Oxygen: The Rate-Limiting Factor for Episodic Memory Performance, Even in Healthy Young Individuals.","Cognition is a crucial element of human functionality. Like any other physical capability, cognition is both enabled and limited by tissue biology. The aim of this study was to investigate whether oxygen is a rate-limiting factor for any of the main cognitive domains in healthy young individuals. Fifty-six subjects were randomly assigned to either increased oxygen supply using hyperbaric oxygen (two atmospheres of 100% oxygen) or to a ""sham"" treatment (a simulation of increased pressure in a chamber with normal air). While in the chamber, participants went through a battery of tests evaluating the major cognitive domains including information processing speed, episodic memory, working memory, cognitive flexibility, and attention. The results demonstrated that from all evaluated cognitive domains, a statistically significant improvement was found in the episodic memory of the hyper-oxygenized group. The hyper-oxygenized group demonstrated a better learning curve and a higher resilience to interference. To conclude, oxygen delivery is a rate-limiting factor for memory function even in healthy young individuals under normal conditions. Understanding the biological limitations of our cognitive functions is important for future development of interventional tools that can be used in daily clinical practice.",2020,"The results demonstrated that from all evaluated cognitive domains, a statistically significant improvement was found in the episodic memory of the hyper-oxygenized group.","['Healthy Young Individuals', 'healthy young individuals', 'healthy young individuals under normal conditions', 'Fifty-six subjects']","['increased oxygen supply using hyperbaric oxygen (two atmospheres of 100% oxygen) or to a ""sham"" treatment (a simulation of increased pressure in a chamber with normal air', 'Oxygen']","['episodic memory', 'major cognitive domains including information processing speed, episodic memory, working memory, cognitive flexibility, and attention']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231162', 'cui_str': 'Normal general body function'}]","[{'cui': 'C0311412', 'cui_str': 'Increased oxygen supply'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0004178', 'cui_str': 'Atmosphere'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0677038', 'cui_str': 'Increase in pressure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",56.0,0.0265434,"The results demonstrated that from all evaluated cognitive domains, a statistically significant improvement was found in the episodic memory of the hyper-oxygenized group.","[{'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Suzin', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Halpert Frolinger', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Yogev', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hadanny', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Catalogna', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Rassovsky', 'Affiliation': 'Department of Psychology, Bar Ilan University, Ramat-Gan 5290002, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Efrati', 'Affiliation': 'The Sagol Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Zerifin 70300, Israel.'}]",Biomolecules,['10.3390/biom10091328']
2440,32957522,"Vitamin C and E Treatment Blunts Sprint Interval Training-Induced Changes in Inflammatory Mediator-, Calcium-, and Mitochondria-Related Signaling in Recreationally Active Elderly Humans.","Sprint interval training (SIT) has emerged as a time-efficient training regimen for young individuals. Here, we studied whether SIT is effective also in elderly individuals and whether the training response was affected by treatment with the antioxidants vitamin C and E. Recreationally active elderly (mean age 65) men received either vitamin C (1 g/day) and vitamin E (235 mg/day) or placebo. Training consisted of nine SIT sessions (three sessions/week for three weeks of 4-6 repetitions of 30-s all-out cycling sprints) interposed by 4 min rest. Vastus lateralis muscle biopsies were taken before, 1 h after, and 24 h after the first and last SIT sessions. At the end of the three weeks of training, SIT-induced changes in relative mRNA expression of reactive oxygen/nitrogen species (ROS)- and mitochondria-related proteins, inflammatory mediators, and the sarcoplasmic reticulum Ca 2+  channel, the ryanodine receptor 1 (RyR1), were blunted in the vitamin treated group. Western blots frequently showed a major (>50%) decrease in the full-length expression of RyR1 24 h after SIT sessions; in the trained state, vitamin treatment seemed to provide protection against this severe RyR1 modification. Power at exhaustion during an incremental cycling test was increased by ~5% at the end of the training period, whereas maximal oxygen uptake remained unchanged; vitamin treatment did not affect these measures. In conclusion, treatment with the antioxidants vitamin C and E blunts SIT-induced cellular signaling in skeletal muscle of elderly individuals, while the present training regimen was too short or too intense for the changes in signaling to be translated into a clear-cut change in physical performance.",2020,"At the end of the three weeks of training, SIT-induced changes in relative mRNA expression of reactive oxygen/nitrogen species (ROS)- and mitochondria-related proteins, inflammatory mediators, and the sarcoplasmic reticulum Ca 2+  channel, the ryanodine receptor 1 (RyR1), were blunted in the vitamin treated group.","['young individuals', 'elderly individuals', 'skeletal muscle of elderly individuals', 'and E. Recreationally active elderly (mean age 65) men']","['vitamin E', 'SIT', 'antioxidants vitamin C and E blunts SIT', 'antioxidants vitamin C', 'placebo', 'Sprint interval training (SIT', 'Vitamin C and E Treatment Blunts Sprint', 'vitamin C']","['relative mRNA expression of reactive oxygen/nitrogen species (ROS)- and mitochondria-related proteins, inflammatory mediators', 'maximal oxygen uptake', 'full-length expression']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",,0.0596438,"At the end of the three weeks of training, SIT-induced changes in relative mRNA expression of reactive oxygen/nitrogen species (ROS)- and mitochondria-related proteins, inflammatory mediators, and the sarcoplasmic reticulum Ca 2+  channel, the ryanodine receptor 1 (RyR1), were blunted in the vitamin treated group.","[{'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Wyckelsma', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Venckunas', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Brazaitis', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gastaldello', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Audrius', 'Initials': 'A', 'LastName': 'Snieckus', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Nerijus', 'Initials': 'N', 'LastName': 'Eimantas', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Neringa', 'Initials': 'N', 'LastName': 'Baranauskiene', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Andrejus', 'Initials': 'A', 'LastName': 'Subocius', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Skurvydas', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Mati', 'Initials': 'M', 'LastName': 'Pääsuke', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, University of Tartu, 50090 Tartu, Estonia.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gapeyeva', 'Affiliation': 'Institute of Sport Sciences and Physiotherapy, University of Tartu, 50090 Tartu, Estonia.'}, {'ForeName': 'Priit', 'Initials': 'P', 'LastName': 'Kaasik', 'Affiliation': 'Laboratory of Functional Morphology, University of Tartu, 50090 Tartu, Estonia.'}, {'ForeName': 'Reedik', 'Initials': 'R', 'LastName': 'Pääsuke', 'Affiliation': 'Department of Traumatology and Orthopaedics, Tartu University Hospital, 50090 Tartu, Estonia.'}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Jürimäe', 'Affiliation': 'Laboratory of Kinanthropometry; University of Tartu, 50090 Tartu, Estonia.'}, {'ForeName': 'Brigitte A', 'Initials': 'BA', 'LastName': 'Graf', 'Affiliation': 'Food and Nutrition Department of Health Professions, Faculty of Health, Manchester Metropolitan University, Manchester M1 5GF, UK.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Kayser', 'Affiliation': 'Institute of Sports Sciences, University of Lausanne, 1015 Lausanne, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Place', 'Affiliation': 'Institute of Sports Sciences, University of Lausanne, 1015 Lausanne, Switzerland.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Andersson', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Sigitas', 'Initials': 'S', 'LastName': 'Kamandulis', 'Affiliation': 'Institute of Sport Science and Innovations, Lithuanian Sports University, 44221 Kaunas, Lithuania.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Westerblad', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, 171 77 Stockholm, Sweden.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9090879']
2441,32957817,Truncal vs Branch Ligation of Inferior Thyroid Arteries in Total Thyroidectomy: Does It Affect Postoperative Hypoparathyroidism?,"OBJECTIVE


Postthyroidectomy hypoparathyroidism remains a significant challenge. Truncal ligation of the inferior thyroid arteries (ITAs) may lead to an increased risk of hypoparathyroidism; however, dissection along the thyroid capsule with branch ligation of the thyroid arteries could be a safer option. This study's objective was to compare the effect of truncal versus branch ligation of the ITAs on the rate of postoperative hypoparathyroidism.
STUDY DESIGN


Randomized prospective trial in line with the CONSORT guidelines.
SETTING


The study was conducted at a high-volume tertiary care setting.
METHODS


We randomized 319 patients into 2 groups: truncal ITA ligation (n = 157) and branch ITA ligation (n = 162). The primary outcomes were serum calcium and parathormone levels on the second postoperative day, followed by the levels on months 1, 3, 6, and 12. The need for exogenous replacements was noted. The secondary outcomes, such as operative time, blood loss, and other complications, were also recorded.
RESULTS


Our study revealed a significant difference in the incidence of transient hypocalcemia in patients undergoing truncal ITA ligation and branch ITA ligation (22.9% vs 3.1%,  P  < .05). The results showed that the levels of serum calcium and parathormone dropped on the second postoperative day and that 36 patients from the truncal ITA ligation group required exogenous calcium and vitamin D replacement. In contrast, only 5 patients from the branch ITA ligation group required the same.
CONCLUSIONS


This is the largest randomized trial of patients undergoing thyroidectomy, and it shows that dissection along the thyroid capsule with branch ligation of the ITAs is more likely to preserve parathyroid function as opposed to truncal ligation of ITAs.",2020,"Truncal ligation of the inferior thyroid arteries (ITAs) may lead to an increased risk of hypoparathyroidism; however, dissection along the thyroid capsule with branch ligation of the thyroid arteries could be a safer option.","['patients undergoing', '319 patients into 2 groups', 'The study was conducted at a high-volume tertiary care setting']","['truncal versus branch ligation of the ITAs', 'thyroidectomy', 'Truncal ligation of the inferior thyroid arteries (ITAs', 'Truncal vs Branch Ligation of Inferior Thyroid Arteries in Total Thyroidectomy', 'branch ITA ligation', 'truncal ITA ligation']","['levels of serum calcium and parathormone', 'serum calcium and parathormone levels', 'operative time, blood loss, and other complications', 'transient hypocalcemia', 'branch ITA ligation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}]","[{'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0226264', 'cui_str': 'Structure of inferior thyroid artery'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}]",319.0,0.0752902,"Truncal ligation of the inferior thyroid arteries (ITAs) may lead to an increased risk of hypoparathyroidism; however, dissection along the thyroid capsule with branch ligation of the thyroid arteries could be a safer option.","[{'ForeName': 'Talat', 'Initials': 'T', 'LastName': 'Waseem', 'Affiliation': 'Shalamar Endocrine and Surgical Oncology Center, Division of Surgical Oncology and Endocrine Surgery, Department of Surgery, Shalamar Medical and Dental College, Lahore, Pakistan.'}, {'ForeName': 'Safia Zahir', 'Initials': 'SZ', 'LastName': 'Ahmed', 'Affiliation': 'Shalamar Endocrine and Surgical Oncology Center, Division of Surgical Oncology and Endocrine Surgery, Department of Surgery, Shalamar Medical and Dental College, Lahore, Pakistan.'}, {'ForeName': 'Hadia', 'Initials': 'H', 'LastName': 'Baig', 'Affiliation': 'Shalamar Endocrine and Surgical Oncology Center, Division of Surgical Oncology and Endocrine Surgery, Department of Surgery, Shalamar Medical and Dental College, Lahore, Pakistan.'}, {'ForeName': 'Muhammad Hasham', 'Initials': 'MH', 'LastName': 'Ashraf', 'Affiliation': 'Shalamar Endocrine and Surgical Oncology Center, Division of Surgical Oncology and Endocrine Surgery, Department of Surgery, Shalamar Medical and Dental College, Lahore, Pakistan.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Azim', 'Affiliation': 'Shalamar Endocrine and Surgical Oncology Center, Division of Surgical Oncology and Endocrine Surgery, Department of Surgery, Shalamar Medical and Dental College, Lahore, Pakistan.'}, {'ForeName': 'Khawaja M', 'Initials': 'KM', 'LastName': 'Azim', 'Affiliation': 'Shalamar Endocrine and Surgical Oncology Center, Division of Surgical Oncology and Endocrine Surgery, Department of Surgery, Shalamar Medical and Dental College, Lahore, Pakistan.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820957283']
2442,32724076,Plasma levels of DPP4 activity and sDPP4 are dissociated from inflammation in mice and humans.,"Dipeptidyl peptidase-4 (DPP4) modulates inflammation by enzymatic cleavage of immunoregulatory peptides and through its soluble form (sDPP4) that directly engages immune cells. Here we examine whether reduction of DPP4 activity alters inflammation. Prolonged DPP4 inhibition increases plasma levels of sDPP4, and induces sDPP4 expression in lymphocyte-enriched organs in mice. Bone marrow transplantation experiments identify hematopoietic cells as the predominant source of plasma sDPP4 following catalytic DPP4 inhibition. Surprisingly, systemic DPP4 inhibition increases plasma levels of inflammatory markers in regular chow-fed but not in high fat-fed mice. Plasma levels of sDPP4 and biomarkers of inflammation are lower in metformin-treated subjects with type 2 diabetes (T2D) and cardiovascular disease, yet exhibit considerable inter-individual variation. Sitagliptin therapy for 12 months reduces DPP4 activity yet does not increase markers of inflammation or levels of sDPP4. Collectively our findings dissociate levels of DPP4 enzyme activity, sDPP4 and biomarkers of inflammation in mice and humans.",2020,Sitagliptin therapy for 12 months reduces DPP4 activity yet does not increase markers of inflammation or levels of sDPP4.,[],"['Dipeptidyl peptidase-4 (DPP4', 'Sitagliptin therapy']","['DPP4 activity', 'DPP4 activity alters inflammation', 'Plasma levels of sDPP4 and biomarkers of inflammation', 'plasma levels of inflammatory markers']",[],"[{'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0392516,Sitagliptin therapy for 12 months reduces DPP4 activity yet does not increase markers of inflammation or levels of sDPP4.,"[{'ForeName': 'Laurie L', 'Initials': 'LL', 'LastName': 'Baggio', 'Affiliation': 'Department of Medicine, Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Elodie M', 'Initials': 'EM', 'LastName': 'Varin', 'Affiliation': 'Department of Medicine, Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Koehler', 'Affiliation': 'Department of Medicine, Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Xiemin', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Medicine, Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Susanna R', 'Initials': 'SR', 'LastName': 'Stevens', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Drucker', 'Affiliation': 'Department of Medicine, Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, Toronto, ON, Canada. drucker@lunenfeld.ca.'}]",Nature communications,['10.1038/s41467-020-17556-z']
2443,32728026,Placebos without deception reduce self-report and neural measures of emotional distress.,"Several recent studies suggest that placebos administered without deception (i.e., non-deceptive placebos) can help people manage a variety of highly distressing clinical disorders and nonclinical impairments. However, whether non-deceptive placebos represent genuine psychobiological effects is unknown. Here we address this issue by demonstrating across two experiments that during a highly arousing negative picture viewing task, non-deceptive placebos reduce both a self-report and neural measure of emotional distress, the late positive potential. These results show that non-deceptive placebo effects are not merely a product of response bias. Additionally, they provide insight into the neural time course of non-deceptive placebo effects on emotional distress and the psychological mechanisms that explain how they function.",2020,"Additionally, they provide insight into the neural time course of non-deceptive placebo effects on emotional distress and the psychological mechanisms that explain how they function.",[],"['placebos', 'Placebos']",['emotional distress'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",,0.140427,"Additionally, they provide insight into the neural time course of non-deceptive placebo effects on emotional distress and the psychological mechanisms that explain how they function.","[{'ForeName': 'Darwin A', 'Initials': 'DA', 'LastName': 'Guevarra', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor, 530 Church St., Ann Arbor, MI, 48109, USA. guevarra@umich.edu.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Moser', 'Affiliation': 'Department of Psychology, Michigan State University, 316 Physics Rd., East Lansing, MI, 48824, USA.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder, 1905 Colorado Ave., Boulder, CO, 80309, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Kross', 'Affiliation': 'Department of Psychology, University of Michigan, Ann Arbor, 530 Church St., Ann Arbor, MI, 48109, USA.'}]",Nature communications,['10.1038/s41467-020-17654-y']
2444,32957900,Resistance exercise versus aerobic exercise combined with metformin therapy in the treatment of type 2 diabetes: a 12-week comparative clinical study.,"BACKGROUNDS


Both exercise and metformin are used to control blood glucose levels in patients with type 2 diabetes mellitus (T2DM) while no previous studies have investigated the effect of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM patients.
OBJECTIVES


This study was conducted to compare the effects of resistance exercise combined with metformin versus aerobic exercise with metformin in T2DM patients Methods: Fifty-seven T2DM patients with a mean age of 46.2±8.3 years were randomized to three study groups, each group included nineteen patients. The first group conducted a resistance exercise program (REP, 50-60% of 1RM, for 40-50 min) combined with metformin, the second group conducted an aerobic exercise program (AEP, 50-70% maxHR, for 40-50 min) combined with metformin, and the third group received only metformin without exercise intervention (Met group). The study program was conducted trice weekly for executive twelve weeks. Fasting blood glucose (FBG), glycated hemoglobin (HbA1c), homeostatic model assessment of insulin resistance (HOMAIR), and maximal oxygen uptake (VO2max) were evaluated before and after study intervention.
RESULTS


Significant differences were reported after the 12-week intervention inter-groups in the outcome variables (p˂0.05). FBG, HbA1c, HOMA-IR, and VO2max improved significantly in REP group (p˂0.001) and also in the AEP group (p=0.016, p=0.036, p=0.024, and p=0.019 respectively) while the Met group showed only significant reduction in FBG (p=0.049), and non-significant changes in HbA1c, HOMA-IR, and VO2max (p˃0.05). REP group achieved greater improvements than AEP group (FBG, p=0.034; HbA1c%, p=0.002; HOMA-IR, p˂0.001; and VO2max, p=0.024).
CONCLUSIONS


Both resistance and aerobic exercise programs combined with metformin are effective in controlling T2DM. Resistance exercise combined with metformin is more effective than aerobic exercise combined with metformin in the treatment of T2DM.",2020,"REP group achieved greater improvements than AEP group (FBG, p=0.034; HbA1c%, p=0.002; HOMA-IR, p˂0.001; and VO2max, p=0.024).
","['type 2 diabetes', 'T2DM patients Methods: Fifty-seven T2DM patients with a mean age of 46.2±8.3 years', 'patients with type 2 diabetes mellitus (T2DM', 'T2DM patients']","['REP', 'AEP', 'Resistance exercise versus aerobic exercise combined with metformin therapy', 'exercise and metformin', 'resistance exercise combined with metformin versus aerobic exercise with metformin', 'aerobic exercise combined with metformin', 'metformin', 'Resistance exercise combined with metformin', 'resistance exercise program (REP, 50-60% of 1RM, for 40-50 min) combined with metformin, the second group conducted an aerobic exercise program (AEP, 50-70% maxHR, for 40-50 min) combined with metformin, and the third group received only metformin without exercise intervention']","['FBG, HbA1c, HOMA-IR, and VO2max', 'HbA1c, HOMA-IR, and VO2max (p˃0.05', 'FBG', 'Fasting blood glucose (FBG), glycated hemoglobin (HbA1c), homeostatic model assessment of insulin resistance (HOMAIR), and maximal oxygen uptake (VO2max']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",57.0,0.0283744,"REP group achieved greater improvements than AEP group (FBG, p=0.034; HbA1c%, p=0.002; HOMA-IR, p˂0.001; and VO2max, p=0.024).
","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia; 2Department of Physical Therapy, Kasr Al-Aini Hospital, Cairo University, Giza. Egypt.'}]","Endocrine, metabolic & immune disorders drug targets",['10.2174/1871530320999200918143227']
2445,32957926,Antinociceptive effects of magnesium sulfate for monitored anesthesia care during hysteroscopy: a randomized controlled study.,"BACKGROUND


Opioids are the most effective antinociceptive agents, they have undesirable side effects such as respiratory depressant and postoperative nausea and vomiting. The purpose of the study was to evaluate the antinociceptive efficacy of adjuvant magnesium sulphate to reduce intraoperative and postoperative opioids requirements and their related side effects during hysteroscopy.
METHODS


Seventy patients scheduled for hysteroscopy were randomly divided into 2 groups. Patients in the magnesium group (Group M) received intravenous magnesium sulfate 50 mg/kg in 100 ml of isotonic saline over 15 min before anesthesia induction and then 15 mg/kg per hour by continuous intravenous infusion. Patients in the control group (Group C) received an equal volume of isotonic saline as placebo. All patients were anesthetized under a BIS guided monitored anesthesia care with propofol and fentanyl. Intraoperative hemodynamic variables were recorded and postoperative pain scores were assessed with verbal numerical rating scale (VNRS) 1 min, 15 min, 30 min, 1 h, and 4 h after recovery of consciousness. The primary outcome of our study was total amount of intraoperative and postoperative analgesics administered.
RESULTS


Postoperative serum magnesium concentrations in Group C were significantly decreased than preoperative levels (0.86 ± 0.06 to 0.80 ± 0.08 mmol/L, P = 0.001) while there was no statistical change in Group M (0.86 ± 0.07 to 0.89 ± 0.07 mmol/L, P = 0.129). Bradycardia did not occur in either group and the incidence of hypotension was comparable between the two groups. Total dose of fentanyl given to patients in Group M was less than the one administered to Group C [100 (75-150) vs 145 (75-175) μg, median (range); P < 0.001]. In addition, patients receiving magnesium displayed lower VNRS scores at 15 min, 30 min, 1 h, and 4 h postoperatively.
CONCLUSIONS


In hysteroscopy, adjuvant magnesium administration is beneficial to reduce intraoperative fentanyl requirement and postoperative pain without cardiovascular side effects. Our study indicates that if surgical patients have risk factors for hypomagnesemia, assessing and correcting magnesium level will be necessary.
TRIAL REGISTRATION


ChiCTR1900024596 . date of registration: July 18th 2019.",2020,Total dose of fentanyl given to patients in Group M was less than the one administered to Group C,"['Seventy patients scheduled for hysteroscopy', 'monitored anesthesia care during hysteroscopy', 'All patients were anesthetized under a BIS guided monitored anesthesia care with']","['magnesium', 'fentanyl', 'propofol and fentanyl', 'adjuvant magnesium sulphate', 'isotonic saline as placebo', 'magnesium sulfate', 'intravenous magnesium sulfate 50\u2009mg/kg in 100\u2009ml of isotonic saline']","['verbal numerical rating scale (VNRS', 'Postoperative serum magnesium concentrations', 'incidence of hypotension', 'total amount of intraoperative and postoperative analgesics administered', 'antinociceptive efficacy', 'VNRS scores', 'postoperative pain scores', 'Bradycardia']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}]",70.0,0.208628,Total dose of fentanyl given to patients in Group M was less than the one administered to Group C,"[{'ForeName': 'Peng-Fei', 'Initials': 'PF', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Jing-Yan', 'Initials': 'JY', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, North Sichuan Medical College, Nanchong, 637000, Sichuan, China. 419931094@qq.com.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Yun-Feng', 'Initials': 'YF', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Guo-Qiang', 'Initials': 'GQ', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01158-9']
2446,32957929,Effects of different sufentanil target concentrations on the MAC BAR  of sevoflurane in patients with carbon dioxide pneumoperitoneum stimulus.,"BACKGROUND


This study aims to observe the effects of different target controlled plasma sufentanil concentrations on the minimum alveolar concentration (MAC) of sevoflurane for blocking adrenergic response (BAR) in patients undergoing laparoscopic cholecystectomy with carbon dioxide pneumoperitoneum stimulation.
METHODS


Eighty-five patients undergoing laparoscopic cholecystectomy, aged 30-65 years, with American Society of Anesthesiologists physical status I-II, were enrolled in this study. All the patients were randomly divided into 5 groups (S 0 , S 1 , S 2 , S 3 , S 4 ) with different sufentanil plasma target concentration (0.0, 0.1, 0.3, 0.5, 0.7 ng ml - 1 ). Anesthesia was induced by inhalation of 8% sevoflurane in 100% oxygen, and 0.6 mg kg - 1  of rocuronium was intravenously injected to facilitate the insertion of a laryngeal mask airway. The end-tidal sevoflurane concentration and sufentanil plasma target concentration were adjusted according to respective preset value in each group. The hemodynamic response to pneumoperitoneum stimulus was observed after the end-tidal sevoflurane concentration had been maintained stable at least for 15 min. The MAC BAR  of sevoflurane was measured by a sequential method. Meanwhile, epinephrine (E) and norepinephrine (NE) concentrations in the blood were also determined before and after pneumoperitoneum stimulus in each group.
RESULTS


When the method of independent paired reversals was used, the MAC BAR  of sevoflurane in groups S 0 , S 1 , S 2 , S 3 , S 4  was 5.333% (confidence interval [CI] 95%: 5.197-5.469%), 4.533% (95% CI: 4.451-4.616%), 2.861% (95% CI: 2.752-2.981%), 2.233% (95% CI: 2.142-2.324%) and 2.139% (95% CI: 2.057-2.219%), respectively. Meanwhile, when the isotonic regression analysis was used, the MAC BAR  of sevoflurane in groups S 0 , S 1 , S 2 , S 3 , S 4  was 5.329% (95% CI: 5.321-5.343%), 4.557% (95% CI: 4.552-4.568%), 2.900% (95% CI: 2.894-2.911%), 2.216% (95% CI: 2.173-2.223%) and 2.171% (95% CI: 2.165-2.183%), respectively. The MAC BAR  was not significantly different between groups S 3  and S 4  when using 0.5 and 0.7 ng ml - 1  of sufentanil plasma target concentrations. No significant difference was found in the change of E or NE concentration between before and after pneumoperitoneum stimulation in each group.
CONCLUSIONS


The MAC BAR  of sevoflurane can be decreased with increasing sufentanil plasma target concentrations. A ceiling effect of the decrease occurred at a sufentanil plasma target concentration of 0.5 ng ml - 1 . When the sympathetic adrenergic response was inhibited in half of the patients to pneumoperitoneum stimulation in each group, the changes of E and NE concentrations showed no significant differences.
TRIAL REGISTRATION


The study was registered at http://www.chictr.org.cn ( ChiCTR1800015819 , 23, April, 2018).",2020,The MAC BAR  was not significantly different between groups S 3  and S 4  when using 0.5 and 0.7 ng ml - 1  of sufentanil plasma target concentrations.,"['Eighty-five patients undergoing laparoscopic cholecystectomy, aged 30-65\u2009years, with American Society of Anesthesiologists physical status I-II', 'patients undergoing laparoscopic cholecystectomy with carbon dioxide pneumoperitoneum stimulation', 'patients with carbon dioxide pneumoperitoneum stimulus']","['rocuronium', 'sufentanil', 'sevoflurane']","['Meanwhile, epinephrine (E) and norepinephrine (NE) concentrations', 'MAC BAR', 'sympathetic adrenergic response', 'change of E or NE concentration', 'end-tidal sevoflurane concentration and sufentanil plasma target concentration', 'MAC BAR  of sevoflurane', 'hemodynamic response to pneumoperitoneum stimulus']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1959953', 'cui_str': 'End tidal sevoflurane concentration'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",85.0,0.155202,The MAC BAR  was not significantly different between groups S 3  and S 4  when using 0.5 and 0.7 ng ml - 1  of sufentanil plasma target concentrations.,"[{'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Anaesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Anaesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China. 879921874@qq.com.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Department of Anaesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Anaesthesiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}, {'ForeName': 'Guoyuan', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Laboratory, Affiliated Hospital of North Sichuan Medical College, Nanchong, 637000, Sichuan, China.'}]",BMC anesthesiology,['10.1186/s12871-020-01160-1']
2447,32957959,"Parents and children active together: a randomized trial protocol examining motivational, regulatory, and habitual intervention approaches.","BACKGROUND


Regular physical activity (PA) is associated with many health benefits during childhood, and tracks into desirable PA patterns and health profiles in adulthood. Interventions designed to support these behaviours among young children are critical. Family-based interventions focusing on parent-child activities together (i.e., co-activity) among preschool-aged children are warranted. Targeting parental support practices can increase the frequency of co-activity, however interventions must move beyond merely building intention and planning skills for successful maintenance. Interventions designed to increase co-activity habit strength may facilitate the sustainability and thus impact child PA. The purpose of this study is to compare the effects of three intervention conditions designed to increase child PA through co-activity: a standard education condition (information about benefits), a planning (action planning, coping planning) + education condition and a habit (context-dependent repetition from prompts and cues) + planning +education condition.
METHODS/DESIGN


A longitudinal three-arm parallel design randomized trial will compare three conditions over six months. Families are eligible if they have at least one child between 3y and 5y that is not meeting 60mins/day of moderate to vigorous physical activity (MVPA). The primary outcome (child MVPA) is assessed via accelerometry at baseline, six weeks, three months and six months (primary endpoint). Intervention materials targeting co-activity are delivered post baseline assessment, with booster sessions at six weeks and three months. Parental co-activity habit, parent-child co-activity and other behavioural constructs are also assessed via questionnaire at all measurement occasions. As tertiary outcomes, parental PA is measured via accelerometry and co-activity is measured via a Bluetooth-enabled proximity feature. A total of 106 families have been recruited thus far from the Greater Victoria region. The study is ongoing with a minimum target of 150 families and an anticipated recruitment completion date of August 2022.
DISCUSSION


This protocol describes the implementation of a randomized trial evaluating the effectiveness of a habit formation group compared with a planning group and an education only group to increase child PA through targeting parent-child co-activity. This information could prove useful in informing public health initiatives to promote PA among families with preschool-aged children.
TRIAL REGISTRATION


This trial was prospectively registered on clinicaltrials.gov in February 2016, identifier NCT03055871 .",2020,"Targeting parental support practices can increase the frequency of co-activity, however interventions must move beyond merely building intention and planning skills for successful maintenance.","['preschool-aged children', 'families with preschool-aged children', '106 families have been recruited thus far from the Greater Victoria region', 'Families are eligible if they have at least one child between 3y and 5y that is not meeting 60mins/day of moderate to vigorous physical activity (MVPA', '150 families and an anticipated recruitment completion date of August 2022']","['Regular physical activity (PA', 'habit formation', 'planning (action planning, coping planning)\u2009+\u2009education condition and a habit (context-dependent repetition from prompts and cues)\u2009+\u2009planning +education condition', 'planning group and an education only group to increase child PA through targeting parent-child co-activity']",['parental PA is measured via accelerometry and co-activity'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",106.0,0.0998405,"Targeting parental support practices can increase the frequency of co-activity, however interventions must move beyond merely building intention and planning skills for successful maintenance.","[{'ForeName': 'Stina J', 'Initials': 'SJ', 'LastName': 'Grant', 'Affiliation': 'Behavioural Medicine Laboratory, School of Exercise Science, Physical and Health Education University of Victoria, Victoria, Canada.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Chris M', 'Initials': 'CM', 'LastName': 'Blanchard', 'Affiliation': 'Department of Medicine, Dalhousie University, Room 205 Centre for Clinical Research, 5790 University Avenue, Halifax, Nova Scotia, B3H 1V7, Canada. chris.blanchard@dal.ca.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Carson', 'Affiliation': 'University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gardner', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Darren E R', 'Initials': 'DER', 'LastName': 'Warburton', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'Behavioural Medicine Laboratory, School of Exercise Science, Physical and Health Education University of Victoria, Victoria, Canada.'}]",BMC public health,['10.1186/s12889-020-09465-z']
2448,32958459,"BioMatrix versus Orsiro Stent for Coronary Artery Disease: A Multicenter, Randomized, Open-Label Study.","AIMS


To compare the safety and efficacy of a thin-strut biodegradable polymer sirolimus-eluting cobalt-chromium stent (Orsiro) to a thick-strut biodegradable polymer biolimus-eluting stent (BioMatrix).
METHODS AND RESULTS


This randomized, open-label, non-inferiority trial was conducted among patients undergoing percutaneous coronary intervention. The primary endpoint was target lesion failure (TLF),. Between 21st July 2014 and 28th September 2017, we randomly assigned 2341 patients to BioMatrix stents (n=1,166) or Orsiro stents (n=1,175 ). We analysed 2327 patients who finished 18-month follow-up. The mean patient age was 63.5 years, and 1565 (67.3%) patients presented with acute coronary syndrome. At 18 months, 34 (2.9%) patients with BioMatrix stents and 24 (2.1%) with Orsiro stents experienced TLF (hazard ratio: 0.70, upper limit of one-sided 95% confidence interval: 1.18, P for non-inferiority &lt;0.0001). No significant differences were noted in rates of cardiac death (16 [1.4%] vs. 12 [1.0%], P=0.558), target lesion-related myocardial infarction (0 [0%] vs. 3 [0.3%], P = 0.250), target lesion revascularization (18 [1.6%] vs. 10 [0.9%], P=0.124), or stent thrombosis (0 [0%] vs. 2 [0.2%], P=0.50).
CONCLUSIONS


In patients with a high prevalence of acute coronary syndrome, Orsiro stents were not inferior to BioMatrix stents. Both showed excellent clinical outcomes.",2020,"No significant differences were noted in rates of cardiac death (16 [1.4%] vs. 12 [1.0%], P=0.558), target lesion-related myocardial infarction (0 [0%] vs. 3 [0.3%], P = 0.250), target lesion revascularization (18 [1.6%] vs. 10 [0.9%], P=0.124), or stent thrombosis (0 [0%] vs. 2 [0.2%], P=0.50).
","['2327 patients who finished 18-month follow-up', 'patients undergoing percutaneous coronary intervention', 'Coronary Artery Disease', 'Between 21st July 2014 and 28th September 2017, we randomly assigned 2341 patients to', 'mean patient age was 63.5 years, and 1565 (67.3%) patients presented with acute coronary syndrome']","['Orsiro stents', 'BioMatrix versus Orsiro Stent', 'thin-strut biodegradable polymer sirolimus-eluting cobalt-chromium stent (Orsiro', 'BioMatrix stents']","['safety and efficacy', 'rates of cardiac death', 'target lesion revascularization', 'target lesion-related myocardial infarction', 'target lesion failure (TLF', 'stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",2341.0,0.154974,"No significant differences were noted in rates of cardiac death (16 [1.4%] vs. 12 [1.0%], P=0.558), target lesion-related myocardial infarction (0 [0%] vs. 3 [0.3%], P = 0.250), target lesion revascularization (18 [1.6%] vs. 10 [0.9%], P=0.124), or stent thrombosis (0 [0%] vs. 2 [0.2%], P=0.50).
","[{'ForeName': 'Chang-Hwan', 'Initials': 'CH', 'LastName': 'Yoon', 'Affiliation': 'Seoul National University Bundang Hospital, Seongnam, Rebublic of Korea.'}, {'ForeName': 'Young Jin', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Jin Joo', 'Initials': 'JJ', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Si-Hyuck', 'Initials': 'SH', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Sun-Hwa', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jung-Won', 'Initials': 'JW', 'LastName': 'Suh', 'Affiliation': ''}, {'ForeName': 'Young-Seok', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Tae-Jin', 'Initials': 'TJ', 'LastName': 'Youn', 'Affiliation': ''}, {'ForeName': 'Myeong-Kon', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Kwang Soo', 'Initials': 'KS', 'LastName': 'Cha', 'Affiliation': ''}, {'ForeName': 'Seung-Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Bum-Kee', 'Initials': 'BK', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Seung-Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': ''}, {'ForeName': 'Woong-Chol', 'Initials': 'WC', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Jae-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Sang-Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Chae', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00185']
2449,32958468,Patients use fewer analgesics following supervised exercise therapy and patient education: an observational study of 16 499 patients with knee or hip osteoarthritis.,"OBJECTIVES


To investigate changes in analgesic use before and after supervised exercise therapy and patient education in patients with knee or hip osteoarthritis (OA).
METHODS


We recruited 16 499 of 25 933 eligible patients (64%; mean age 64.9; SD 9.6; 73% women) from the Good Life with osteoArthritis in Denmark (GLA:D) registry. Change in proportions of analgesic users (categorised according to analgesic risk profile; opioids > non-steroidal anti-inflammatory drugs > paracetamol) was assessed from before to after an 8-week supervised exercise therapy and patient education programme targeting knee or hip OA pain and functional limitations.
RESULTS


Patients reported 13.2 mm (95% CI 12.8 to 13.6) less pain (visual analogue scale 0-100 mm) at follow-up compared with baseline. The proportion of analgesic users reduced from 62.2% (95% CI 61.5 to 63.0) at baseline to 44.1% (95% CI 43.3 to 44.9) at follow-up (absolute change: 18.1% (95% CI 17.3 to 19.0)). Among patients using analgesics at baseline, 52% changed to a lower risk analgesic or discontinued analgesic use. The proportion of opioid users after the exercise therapy was 2.5% (95% CI 2.1 to 2.9) lower than baseline; this represents a relative reduction of 36%.
CONCLUSION


Among patients with knee or hip OA using analgesics, more than half either discontinued analgesic use or shifted to lower risk analgesics following an 8-week structured exercise therapy and patient education programme (GLA:D). These data encourage randomised controlled trial evaluation of whether supervised exercise therapy, combined with patient education, can reduce analgesic use, including opioids, among patients with knee and hip OA pain.",2020,The proportion of analgesic users reduced from 62.2% (95% CI 61.5 to 63.0) at baseline to 44.1% (95% CI 43.3 to 44.9) at follow-up (absolute change: 18.1% (95% CI 17.3 to 19.0)).,"['patients with knee or hip osteoarthritis (OA', 'We recruited 16 499 of 25 933 eligible patients (64%; mean age 64.9; SD 9.6; 73% women) from the Good Life with osteoArthritis in Denmark (GLA:D) registry', '16\u2009499 patients with knee or hip osteoarthritis', 'patients with knee or hip OA using analgesics', 'patients with knee and hip OA pain']","['supervised exercise therapy and patient education', 'supervised exercise therapy']","['proportion of analgesic users', 'proportion of opioid users', 'pain (visual analogue scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C5191368', 'cui_str': '933'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",25933.0,0.114666,The proportion of analgesic users reduced from 62.2% (95% CI 61.5 to 63.0) at baseline to 44.1% (95% CI 43.3 to 44.9) at follow-up (absolute change: 18.1% (95% CI 17.3 to 19.0)).,"[{'ForeName': 'Jonas Bloch', 'Initials': 'JB', 'LastName': 'Thorlund', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark jthorlund@health.sdu.dk.'}, {'ForeName': 'Ewa M', 'Initials': 'EM', 'LastName': 'Roos', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Goro', 'Affiliation': 'School of Medicine, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Emily Gromelsky', 'Initials': 'EG', 'LastName': 'Ljungcrantz', 'Affiliation': 'School of Medicine, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Dorte Thalund', 'Initials': 'DT', 'LastName': 'Grønne', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark.'}, {'ForeName': 'Søren T', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101265']
2450,32958483,Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial.,"INTRODUCTION


Approximately one out of six patients in primary care suffers from depression, which often remains undetected. Evidence regarding the efficacy of depression screening in primary care, however, is inconsistent. A previous single-centre randomised controlled trial (RCT) in cardiac patients, the DEPSCREEN-INFO trial, provided the first evidence that written feedback to patients following a positive depression screening reduces depression severity and leads to more comprehensive patient engagement in mental healthcare. To amplify these effects, the feedback should be tailored according to patients' needs and preferences. The GET.FEEDBACK.GP RCT will test the efficacy of this patient-targeted feedback intervention in primary care.
METHODS AND ANALYSIS


The multicentre three-arm GET.FEEDBACK.GP RCT aims to recruit a total of 1074 primary care patients from North, East and South Germany. Patients will be screened for depression using the Patient Health Questionnaire-9 (PHQ-9). In the case of a positive depression screening result (PHQ-9 score ≥10), the participant will be randomised into one of three groups to either receive (a) patient-targeted and general practitioner (GP)-targeted feedback regarding the depression screening results, (b) only GP-targeted feedback or (c) no feedback. Patients will be followed over a period of 12 months. The primary outcome is depression severity (PHQ-9) 6 months after screening. Secondary outcomes include patient engagement in mental healthcare, professional depression care and cost-effectiveness. According to a statistical analysis plan, the primary endpoint of all randomised patients will be analysed regarding the intention-to-treat principle.
ETHICS AND DISSEMINATION


The Ethics Committee of the Hamburg Medical Association approved the study. A clinical trial company will ensure data safety, monitoring and supervision. The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening. Its results have the potential to influence future depression guidelines and will be disseminated in scientific as well as patient-friendly language.
TRIAL REGISTRATION NUMBER


NCT03988985.",2020,The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening.,"['1074 primary care patients from North, East and South Germany', 'cardiac patients']","['Depression screening using patient-targeted feedback', 'patient-targeted feedback intervention', 'receive (a) patient-targeted and general practitioner (GP)-targeted feedback regarding the depression screening results, (b) only GP-targeted feedback or (c) no feedback']","['patient engagement in mental healthcare, professional depression care and cost-effectiveness', 'depression severity (PHQ-9']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",1074.0,0.195457,The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening.,"[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kohlmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany s.kohlmann@uke.de.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Lehmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Eisele', 'Affiliation': 'Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lea-Elena', 'Initials': 'LE', 'LastName': 'Braunschneider', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Marx', 'Affiliation': 'Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Zapf', 'Affiliation': 'Department of Biostatistics and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Biostatistics and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gallinat', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Joos', 'Affiliation': 'Department of Primary Care, University Medical Centre Tübingen, Tübingen, Germany.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Resmark', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Antonius', 'Initials': 'A', 'LastName': 'Schneider', 'Affiliation': 'Department of Primary Care, Technical University of Munich Hospital Rechts der Isar, Munchen, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Allwang', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Technical University of Munich Hospital Rechts der Isar, Munchen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Szecsenyi', 'Affiliation': 'Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nikendei', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy for General Internal Medicine and Psychosomatics, University Medical Centre of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schulz', 'Affiliation': 'Department of Primary Care, University Medical Centre Jena, Jena, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Brenk-Franz', 'Affiliation': 'Department of Psychosocial Medicine and Psychotherapy, University Medical Centre Jena, Jena, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scherer', 'Affiliation': 'Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Löwe', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-035973']
2451,32958487,Nurse-led patient-centred intervention to increase written advance directives for outpatients in early-stage palliative care: study protocol for a randomised controlled trial with an embedded explanatory qualitative study.,"INTRODUCTION


Discussing the evolution of life-threatening diseases and end-of-life issues remains difficult for patients, relatives and professionals. Helping people discuss and formalise their preferences in end-of-life care, as planned in the Go Wish intervention, could reduce health-related anxiety in the advance care planning (ACP) and advance directive (AD) process. The aims of this study are (1) to test the effectiveness of the Go Wish intervention among outpatients in early-stage palliative care and (2) to understand the role of defence mechanisms in end-of-life discussions among nurses, patients and relatives.
METHODS AND ANALYSIS


A mixed-methods study will be performed. A cluster randomised controlled trials with three parallel arms will be conducted with 45 patients with chronic progressive diseases impacting life expectancy in each group: (1) Group A, Go Wish intervention for patients and their relatives; (2) Group A, Go Wish intervention for patients alone and (3) Group B, for patients (with a waiting list), who will receive the standardised information on ADs (usual care). Randomisation will be at the nurse level as each patient is referred to one of the 20 participating nurses (convenience sample of 20 nurses). A qualitative study will be conducted to understand the cognitive and emotional processes and experiences of nurses, patients and relatives confronted with end-of-life discussions. The outcome measurements include the completion of ADs (yes/no), anxiety, quality of communication about end-of-life care, empowerment, quality of life and attitudes towards ADs.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Human Research Ethics Committee of the Canton of Geneva, Switzerland (no. 2019-00922). The findings will be disseminated to practice (nurses, patients and relatives), to national and international scientific conferences, and peer-reviewed journals covering nursing science, psychology and medicine.
TRIAL REGISTRATION NUMBER


NCT04065685.",2020,"Discussing the evolution of life-threatening diseases and end-of-life issues remains difficult for patients, relatives and professionals.","['outpatients in early-stage palliative care', '45 patients with chronic progressive diseases impacting life expectancy in each group', '20 participating nurses (convenience sample of 20 nurses', 'outpatients in early-stage palliative care and (2']",['Nurse-led patient-centred intervention to increase written advance directives'],"['completion of ADs (yes/no), anxiety, quality of communication about end-of-life care, empowerment, quality of life and attitudes towards ADs']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039548', 'cui_str': 'Terminal care'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",45.0,0.102533,"Discussing the evolution of life-threatening diseases and end-of-life issues remains difficult for patients, relatives and professionals.","[{'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Iglesias', 'Affiliation': 'School of Health Sciences (HEdS-FR), HES-SO University of Applied Sciences and Arts Western Switzerland, Friourg, Switzerland katia.iglesias@hefr.ch.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Busnel', 'Affiliation': 'Geneva Institution for Homecare and Assistance (imad), Geneva, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Dufour', 'Affiliation': 'School of Management and Engineering Vaud (HEIG-VD), HES-SO University of Applied Sciences and Arts Western Switzerland, Yverdon, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pautex', 'Affiliation': 'Division of Palliative Medicine, Department of rehabilitation and geriatrics, University Hospitals Geneva, Geneva, Switzerland.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Séchaud', 'Affiliation': 'Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2020-037144']
2452,32965797,Short-term water deprivation attenuates the exercise pressor reflex in older female adults.,"Older adults have reduced fluid intake and impaired body fluid and electrolyte regulation. Older female adults exhibit exaggerated exercise blood pressure (BP) responses, which is associated with an increased risk of adverse cardiovascular events. However, it is unclear if dysregulated body fluid homeostasis contributes to altered exercise BP responses in older female adults. We tested the hypothesis that short-term water deprivation (WD) increases exercise BP responses in older female adults. Fifteen female adults (eight young [25 ± 6 years] and seven older [65 ± 6 years]) completed two experimental conditions in random crossover fashion; a euhydration control condition and a stepwise reduction in water intake over three days concluding with a 16-hr WD period. During both trials, beat-to-beat BP (photoplethysmography) and heart rate (electrocardiogram) were continuously assessed during rest, handgrip exercise (30% MVC), and post-exercise ischemia (metaboreflex isolation). At screening, older compared to young female adults had greater systolic and diastolic BP (p ≤ .02). Accelerometer-assessed habitual physical activity was not different between groups (p = .65). Following WD, 24-hr urine flow rate decreased, whereas thirst, urine specific gravity, and plasma osmolality increased (condition: p < .05 for all), but these WD-induced changes were not different between age groups (interaction: p ≥ .31 for all). Resting systolic and diastolic BP values were higher in older compared to young adults (p < .01 for both), but were not different between experimental conditions (p ≥ .20). In contrast to our hypothesis, WD was associated with attenuated systolic BP responses during handgrip exercise (post hoc: p < .01) and post-exercise ischemia (post hoc: p = .03) in older, but not young, female adults. These data suggest that reduced water intake-induced challenges to body fluid homeostasis do not contribute to exaggerated exercise BP responses in post-menopausal female adults.",2020,"Resting systolic and diastolic BP values were higher in older compared to young adults (p < .01 for both), but were not different between experimental conditions (p ≥ .20).","['Older adults', 'older female adults', 'post-menopausal female adults', 'Older female adults', 'Fifteen female adults (eight young [25\xa0±\xa06\xa0years] and seven older [65\xa0±']","['short-term water deprivation (WD', 'Short-term water deprivation']","['systolic and diastolic BP', 'exercise pressor reflex', 'post-exercise ischemia', '24-hr urine flow rate', 'systolic BP responses', 'exercise blood pressure (BP) responses', 'urine specific gravity, and plasma osmolality', 'Resting systolic and diastolic BP values', 'exercise BP responses', 'Accelerometer-assessed habitual physical activity', 'beat-to-beat BP (photoplethysmography) and heart rate (electrocardiogram']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0043048', 'cui_str': 'Water Deprivation'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202517', 'cui_str': 'Urinalysis, specific gravity measurement'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",15.0,0.057706,"Resting systolic and diastolic BP values were higher in older compared to young adults (p < .01 for both), but were not different between experimental conditions (p ≥ .20).","[{'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Melissa A H', 'Initials': 'MAH', 'LastName': 'Witman', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Wenner', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Stocker', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}]",Physiological reports,['10.14814/phy2.14581']
2453,32960521,HCG trigger versus GnRH agonist trigger in PCOS patients undergoing IVF cycles: frozen embryo transfer outcomes.,"OBJECTIVE


The use of Gonadotrophin releasing hormone agonist (GnRHa), with freeze-all strategy followed by frozen embryo transfer (FET) has been found to eliminate the risk of ovarian hyperstimulation syndrome (OHSS) in women with polycystic ovarian syndrome (PCOS) undergoing IVF cycles. However, physicians still hesitate to routinely use GnRHa as a trigger, replacing human chorionic gonadotrophin (hCG), for concerns of compromised cycle outcome. We aimed to evaluate outcomes following the transfer of embryos in FET cycles obtained from GnRHa trigger in comparison with hCG trigger in PCOS patients of Asian origin.
METHODS


Prospective observational cohort study. 210 PCOS patients undergoing IVF in an antagonist protocol who were randomized in the previous study (to evaluate if GnRHa trigger is a better alternative than hCG in PCOS patients to prevent OHSS; Group A: GnRHa trigger (n=92)] and Group B: hCG trigger (n=101)], were followed up in FET cycles to assess the outcomes.
RESULTS


The odds of cumulative live birth rate per stimulation cycle favors GnRHa trigger against the hCG trigger [OR=2.15; (CI 1.2-3.83); p=0.008]. A significantly higher number of mature oocytes (19.1±11.7 versus 14.1±4.3; p<0.001) and blastocysts (4.2±1.63 versus 3.26±1.22; p<0.001) were available in the GnRHa group as compared to the hCG group.
CONCLUSION


The cumulative live birth rate was better following transfer of frozen-thawed embryos generated from GnRHa-triggered cycles compared to hCG trigger. Hence, in PCOS undergoing IVF, as a good practice point, hCG trigger should be replaced by a GnRHa trigger with vitrification of all embryos followed by FET.",2020,The cumulative live birth rate was better following transfer of frozen-thawed embryos generated from GnRHa-triggered cycles compared to hCG trigger.,"['PCOS patients undergoing IVF cycles', '210 PCOS patients undergoing IVF in an antagonist protocol', 'women with polycystic ovarian syndrome (PCOS) undergoing IVF cycles', 'PCOS patients of Asian origin']","['Gonadotrophin releasing hormone agonist (GnRHa), with freeze-all strategy followed by frozen embryo transfer (FET', 'HCG', 'hCG']","['cumulative live birth rate', 'cumulative live birth rate per stimulation cycle favors GnRHa trigger against the hCG trigger', 'number of mature oocytes']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425357', 'cui_str': 'Asian origin'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}]",210.0,0.111623,The cumulative live birth rate was better following transfer of frozen-thawed embryos generated from GnRHa-triggered cycles compared to hCG trigger.,"[{'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Deepika', 'Affiliation': 'Milann, the fertility Centre, Bangalore, India.'}, {'ForeName': 'Rathore', 'Initials': 'R', 'LastName': 'Suvarna', 'Affiliation': 'Milann, the fertility Centre, Bangalore, India.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sumi', 'Affiliation': 'Milann, the fertility Centre, Bangalore, India.'}, {'ForeName': 'Dhoble', 'Initials': 'D', 'LastName': 'Snehal', 'Affiliation': 'Milann, the fertility Centre, Bangalore, India.'}, {'ForeName': 'Vohra', 'Initials': 'V', 'LastName': 'Arveen', 'Affiliation': 'Milann, the fertility Centre, Bangalore, India.'}, {'ForeName': 'Kamath', 'Initials': 'K', 'LastName': 'Anuja', 'Affiliation': 'Milann, the fertility Centre, Bangalore, India.'}, {'ForeName': 'Pranesh', 'Initials': 'P', 'LastName': 'Gautham', 'Affiliation': 'Milann, the fertility Centre, Bangalore, India.'}, {'ForeName': 'Rao', 'Initials': 'R', 'LastName': 'Kamini', 'Affiliation': 'Milann, the fertility Centre, Bangalore, India.'}]",JBRA assisted reproduction,['10.5935/1518-0557.20200028']
2454,32960532,"More Predictable Return of Motor Function with Mepivacaine Versus Bupivacaine Spinal Anesthetic in Total Hip and Total Knee Arthroplasty: A Double-Blinded, Randomized Clinical Trial.","BACKGROUND


Spinal anesthesia provides several benefits for patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA), but historically comes at the cost of slow and unpredictable return of lower-extremity motor function related to the use of long-acting local anesthetics. In this prospective, double-blinded, randomized clinical trial we sought to determine if an alternative local anesthetic, mepivacaine, would allow more consistent return of motor function compared with low-dose bupivacaine spinal anesthesia during primary THA and TKA.
METHODS


This trial was conducted at a single academic institution. Prior to trial initiation an internal pilot study determined that 154 patients were required to achieve 80% power. Patients were randomized in a 1:1 fashion with use of advanced computerized stratification based on procedure, age group, sex, and body mass index. Following the surgical procedure, motor function was assessed every 15 minutes in the nonoperative lower extremity according to the Bromage scale and discontinued once Bromage 0 was achieved (spontaneous movement at hip, knee, and ankle).
RESULTS


Return of lower-extremity function was more predictable in patients who received mepivacaine than in those who received low-dose bupivacaine. Among patients who received mepivacaine, 1% achieved motor function return beyond 5 hours compared with 11% of patients who received bupivacaine (p = 0.013). The mean time to return of lower-extremity motor function was 26 minutes quicker in patients who received mepivacaine (185 minutes; 95% confidence interval, 174 to 196 minutes) compared with low-dose bupivacaine (210 minutes; 95% confidence interval, 193 to 228 minutes) (p = 0.016). There were no significant differences in safety outcomes including pain scores, time to participation in physical therapy, incidence of orthostatic hypotension, urinary retention, or transient neurologic symptoms in patients receiving mepivacaine compared with low-dose bupivacaine.
CONCLUSIONS


In patients undergoing primary THA and TKA, spinal anesthesia with mepivacaine allowed more consistent return of lower-extremity motor function compared with low-dose bupivacaine, without a concomitant increase in complications potentially associated with spinal anesthetics. This is particularly of value in an era of short-stay and outpatient surgical procedures.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"There were no significant differences in safety outcomes including pain scores, time to participation in physical therapy, incidence of orthostatic hypotension, urinary retention, or transient neurologic symptoms in patients receiving mepivacaine compared with low-dose bupivacaine.
","['patients undergoing primary THA and TKA, spinal anesthesia with', 'Total Hip and Total Knee Arthroplasty', 'patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA', '154 patients were required to achieve 80% power']","['bupivacaine', 'mepivacaine', 'Mepivacaine', 'Bupivacaine Spinal Anesthetic', 'bupivacaine spinal anesthesia']","['pain scores, time to participation in physical therapy, incidence of orthostatic hypotension, urinary retention, or transient neurologic symptoms', 'motor function return', 'motor function', 'mean time to return of lower-extremity motor function', 'lower-extremity motor function', 'Return of lower-extremity function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C5191279', 'cui_str': '154'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",154.0,0.258569,"There were no significant differences in safety outcomes including pain scores, time to participation in physical therapy, incidence of orthostatic hypotension, urinary retention, or transient neurologic symptoms in patients receiving mepivacaine compared with low-dose bupivacaine.
","[{'ForeName': 'Cody C', 'Initials': 'CC', 'LastName': 'Wyles', 'Affiliation': '1Department of Orthopedic Surgery (C.C.W., M.W.P., R.T.T., R.J.S., M.J.T., K.I.P., and M.P.A.), Division of Biomedical Statistics and Informatics (D.R.L.), and Department of Anesthesiology and Perioperative Medicine (A.W.A., H.M.S., and C.M.D.), Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Pagnano', 'Affiliation': ''}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Trousdale', 'Affiliation': ''}, {'ForeName': 'Rafael J', 'Initials': 'RJ', 'LastName': 'Sierra', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Taunton', 'Affiliation': ''}, {'ForeName': 'Kevin I', 'Initials': 'KI', 'LastName': 'Perry', 'Affiliation': ''}, {'ForeName': 'Dirk R', 'Initials': 'DR', 'LastName': 'Larson', 'Affiliation': ''}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Amundson', 'Affiliation': ''}, {'ForeName': 'Hugh M', 'Initials': 'HM', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Duncan', 'Affiliation': ''}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Abdel', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00231']
2455,32960536,Does the Treatment After Kasai Procedure Influence Biliary Atresia Outcome and Native Liver Survival?,"OBJECTIVES


Biliary atresia (BA) is a rare and progressive idiopathic disease affecting the biliary tract that can lead to end-stage liver disease. The main treatment is Kasai portoenterostomy (KP). The use of adjuvant therapy (AT; prophylactic antibiotics and steroids) after KP aims to prevent cholangitis and reduce the need for liver transplantation (LT), but there is a lack of evidence on their effectiveness. We investigated the impact of significant changes in the post-KP protocol on the overall outcomes of BA.
METHODS


We enrolled 43 consecutive infants undergoing KP at Bambino Gesù Children's Hospital between July 2012 and October 2018. We compared AT (AT group; n=25) against no treatment (AT-free group; n = 18).
RESULTS


No significant differences in anthropometric and laboratory parameters were shown between the 2 groups at baseline and every study evaluation (1, 3, and 6 months). The incidences of clinical complications of liver disease were similar. Six months post-KP, the achievement of serum total bilirubin ≤1.5 mg/dL and satisfactory Pediatric End-Stage Liver Disease scores were not significantly different between the 2 groups. Cholangitis was observed in 30% of patients in the first 6 months postoperatively: 33% and 28% in the AT-free and AT groups, respectively (P = 0.18). Survival to LT listing at 12 months and without LT at 24 months were not significantly different between the 2 groups (P > 0.05).
CONCLUSIONS


AT after KP confirmed conflicting results; therefore, multicentered, prospective, randomized control studies are needed to better understand its utility after KP, especially in the multidrug resistance spread era.",2020,"Survival to LT listing at 12 months and without LT at 24 months were not significantly different between the 2 groups (P > 0.05).
","[""43 consecutive infants undergoing KP at Bambino Gesù Children's Hospital between July 2012 and October 2018""]",['adjuvant therapy (AT; prophylactic antibiotics and steroids'],"['serum total bilirubin', 'Survival to LT listing', 'anthropometric and laboratory parameters', 'Biliary Atresia Outcome and Native Liver Survival', 'satisfactory Pediatric End-Stage Liver Disease scores', 'clinical complications of liver disease', 'Cholangitis']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032722', 'cui_str': 'Hepatic portoenterostomy'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005411', 'cui_str': 'Congenital biliary atresia'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C4316678', 'cui_str': 'Pediatric end stage liver disease score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0008311', 'cui_str': 'Cholangitis'}]",43.0,0.0668329,"Survival to LT listing at 12 months and without LT at 24 months were not significantly different between the 2 groups (P > 0.05).
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pietrobattista', 'Affiliation': ""*Department of Hepatology, Gastroenterology and Nutrition †Division of Abdominal Transplantation and Hepatobiliopancreatic Surgery, Bambino Gesù Children's Hospital IRCCS, 00165 Rome, Italy.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Mosca', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Liccardo', 'Affiliation': ''}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Alterio', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Grimaldi', 'Affiliation': ''}, {'ForeName': 'MariaSole', 'Initials': 'M', 'LastName': 'Basso', 'Affiliation': ''}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Saffioti', 'Affiliation': ''}, {'ForeName': 'Claudia Della', 'Initials': 'CD', 'LastName': 'Corte', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spada', 'Affiliation': ''}, {'ForeName': 'Manila', 'Initials': 'M', 'LastName': 'Candusso', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002837']
2456,32960886,Effects of telephone-based health coaching on patient-reported outcomes and health behavior change: A randomized controlled trial.,"OBJECTIVE


Telephone based health coaching (TBHC) seems to be a promising approach to foster self-management in patients with chronic conditions. The aim of this study was to evaluate the effectiveness of a TBHC on patient-reported outcomes and health behavior for people living with chronic conditions in Germany.
METHODS


Patients insured at a statutory health insurance were randomized to an intervention group (IG; TBHC) and a control group (CG; usual care), using a stratified random allocation before giving informed consent (Zelen's single-consent design). The TBHC was based on motivational interviewing, goal setting, and shared decision-making and carried out by trained nurses. All outcomes were assessed yearly for three years. We used mixed effects models utilizing all available data in a modified intention-to-treat sample for the main analysis. Participants and study centers were included as random effects. All models were adjusted for age, education and campaign affiliation.
RESULTS


Of the 10,815 invited patients, 4,283 returned their questionnaires at baseline. The mean age was 67.23 years (SD = 9.3); 55.5% were female. According to the model, TBHC was statistically significant superior to CG regarding 6 of 19 outcomes: physical activity in hours per week (p = .030) and in metabolic rate per week (p = .048), BMI (p = .009) (although mainly at baseline), measuring blood pressure (p< .001), patient activation (p< .001), and health literacy (p< .001). Regarding stages of change (p = .005), the IG group also showed statistically different results than the CG group, however the conclusion remains inconclusive. Within-group contrasts indicating changes from baseline to follow-ups and significant between-group comparisons regarding these changes supported the findings. Standardized effect sizes were small. TBHC did not show any effect on mental QoL, health status, alcohol, smoking, adherence, measuring blood sugar, foot monitoring, anxiety, depression and distress. Campaign-specific subgroup effects were detected for 'foot monitoring by a physician' and 'blood sugar measurement'.
CONCLUSION


TBHC interventions might have small effects on some patient reported and behavioral outcomes.
PRACTICE IMPLICATIONS


Future research should focus on analyzing which intervention components are effective and who profits most from TBHC interventions.
REGISTRATION


German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS): DRKS00000584.",2020,"Regarding stages of change (p = .005), the IG group also showed statistically different results than the CG group, however the conclusion remains inconclusive.","['people living with chronic conditions in Germany', '10,815 invited patients', 'The mean age was 67.23 years (SD = 9.3); 55.5% were female', 'Patients insured at a statutory health insurance', 'patients with chronic conditions']","['TBHC', 'Telephone based health coaching (TBHC', 'control group (CG; usual care', 'intervention group (IG; TBHC', 'telephone-based health coaching']","['BMI', 'mental QoL, health status, alcohol, smoking, adherence, measuring blood sugar, foot monitoring, anxiety, depression and distress', 'metabolic rate', 'blood pressure', 'physical activity', 'health behavior change', 'health literacy', 'patient activation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}]",10815.0,0.0789462,"Regarding stages of change (p = .005), the IG group also showed statistically different results than the CG group, however the conclusion remains inconclusive.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dwinger', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Rezvani', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Herbarth', 'Affiliation': 'Kaufmännische Krankenkasse, Statutory Health Insurance, Hannover, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",PloS one,['10.1371/journal.pone.0236861']
2457,32958026,The effect of physiotherapy including frequent changes of body position and stimulation to physical activity for infants hospitalised with acute airway infections. Study protocol for a randomised controlled trial.,"BACKGROUND


Every year, many infants are infected with the respiratory syncytial virus (RSV) or other agents and need hospitalisation due to bronchiolitis. The disease causes much suffering and high costs. Thus, it is important that the treatment methods are both effective and cost-efficient. The use of different physiotherapy treatment methods is debated, and not all methods are evaluated scientifically. The clinical praxis in Sweden that includes frequent changes of body position and stimulation to physical activity has not previously been evaluated. The aim of this clinical study is to evaluate this praxis.
METHODS


This study is a clinical two-centre individually randomised controlled trial (RCT) with three parallel groups. The participants will be randomly assigned to an individualised physiotherapy intervention, a non-individualised intervention, or a control group. All three groups will receive the standard care at the ward, and the two intervention groups will receive additional treatment, including different movements of the body. The primary outcome measure is a clinical index based on determinants for hospitalisation. Baseline assessments will be compared with the assessments after 24 h. The secondary outcome measures include vital signs, the parents' observations, time spent at the hospital ward, and referrals to an intensive care unit. We also want see if there is any immediate effect of the first intervention, after 20 min.
DISCUSSION


This study will add knowledge about the effect of two physiotherapy interventions that are commonly in use in Swedish hospitals for infants with bronchiolitis or other acute lower respiratory tract infections.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03575091 . Registered July 2, 2018-retrospectively registered.",2020,"The participants will be randomly assigned to an individualised physiotherapy intervention, a non-individualised intervention, or a control group.","['infants hospitalised with acute airway infections', 'Swedish hospitals for infants with bronchiolitis or other acute lower respiratory tract infections']","['physiotherapy', 'individualised physiotherapy intervention, a non-individualised intervention, or a control group', 'physiotherapy interventions']","['clinical index based on determinants for hospitalisation', ""vital signs, the parents' observations, time spent at the hospital ward, and referrals to an intensive care unit""]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",,0.155962,"The participants will be randomly assigned to an individualised physiotherapy intervention, a non-individualised intervention, or a control group.","[{'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Andersson-Marforio', 'Affiliation': 'Department of Health Sciences, Lund University, Margaretavägen 1B, S-22240, Lund, Sweden. sonja.andersson_marforio@med.lu.se.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Lundkvist Josenby', 'Affiliation': 'Department of Health Sciences, Lund University, Margaretavägen 1B, S-22240, Lund, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ekvall Hansson', 'Affiliation': 'Department of Health Sciences, Lund University, Margaretavägen 1B, S-22240, Lund, Sweden.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hansen', 'Affiliation': ""Children's Hospital, Skåne University Hospital, S-22185, Lund, Sweden.""}]",Trials,['10.1186/s13063-020-04681-9']
2458,32958075,The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study.,"BACKGROUND


We evaluated the efficacy of fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, in patients with chronic migraine (CM) with and without medication overuse (MO).
METHODS


In a 12-week, phase 3 trial, patients with CM were randomized to fremanezumab quarterly (675 mg/placebo/placebo), monthly (675 mg/225 mg/225 mg), or placebo. Post hoc analyses assessed the impact of fremanezumab in patients with and without MO (monthly use of acute headache medication ≥15 days, migraine-specific acute medication ≥10 days, or combination medication ≥10 days) on efficacy outcomes, including headache days of at least moderate severity (HDs), and six-item Headache Impact Test (HIT-6) and Migraine-Specific Quality of Life (MSQoL) questionnaire scores.
RESULTS


Of 1130 patients enrolled, 587 (51.9%) had baseline MO. Fremanezumab reduced placebo-adjusted least-squares mean (95% confidence interval) monthly HDs (- 2.2 [- 3.1 to - 1.2] and - 2.7 [- 3.7 to - 1.8]; P < 0.0001) in patients with MO and without MO (quarterly - 1.4 [- 2.3 to - 0.5], P = 0.0026; monthly - 1.4 [- 2.3 to - 0.6], P = 0.0017). Significantly more fremanezumab-treated patients had ≥ 50% reduction in HDs versus placebo, regardless of baseline MO (with: quarterly 70/201 [34.8%], monthly 78/198 [39.4%] vs placebo 26/188 [13.8%]; without: quarterly 71/174 [40.8%], monthly 75/177 [42.4%] vs placebo 41/183 [22.4%]). Fremanezumab improved HIT-6 and MSQoL scores. Significantly more fremanezumab-treated patients reverted to no MO (quarterly 111/201 [55.2%], monthly 120/198 [60.6%]) versus placebo (87/188 [46.3%]).
CONCLUSIONS


Fremanezumab is effective for prevention of migraine in patients with CM, regardless of MO, and demonstrated a benefit over placebo in reducing MO.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02621931 (HALO CM), registered December 12, 2012.",2020,"Significantly more fremanezumab-treated patients had ≥ 50% reduction in HDs versus placebo, regardless of baseline MO (with: quarterly 70/201 [34.8%], monthly 78/198 [39.4%] vs placebo 26/188 [13.8%]; without: quarterly 71/174 [40.8%], monthly 75/177 [42.4%] vs placebo 41/183 [22.4%]).","['patients with CM', 'patients with chronic migraine (CM) with and without medication overuse (MO', '1130 patients enrolled, 587 (51.9%) had baseline MO', 'patients with and without MO (monthly use of acute headache medication ≥15\u2009days, migraine-specific acute medication ≥10\u2009days, or combination medication ≥10\u2009days) on', 'patients with chronic migraine']","['fremanezumab', 'Fremanezumab reduced placebo', 'placebo', 'Fremanezumab', 'fremanezumab quarterly (675\u2009mg/placebo/placebo']","['Fremanezumab improved HIT-6 and MSQoL scores', 'efficacy outcomes, including headache days of at least moderate severity (HDs), and six-item Headache Impact Test (HIT-6) and Migraine-Specific Quality of Life (MSQoL) questionnaire scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C3266697', 'cui_str': 'Medication overuse'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C4517854', 'cui_str': '675'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1130.0,0.393423,"Significantly more fremanezumab-treated patients had ≥ 50% reduction in HDs versus placebo, regardless of baseline MO (with: quarterly 70/201 [34.8%], monthly 78/198 [39.4%] vs placebo 26/188 [13.8%]; without: quarterly 71/174 [40.8%], monthly 75/177 [42.4%] vs placebo 41/183 [22.4%]).","[{'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Thomas Jefferson University, 900 Walnut Street, Second Floor, Philadelphia, PA, 19107, USA. Stephen.Silberstein@jefferson.edu.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Seminerio', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Sait', 'Initials': 'S', 'LastName': 'Ashina', 'Affiliation': 'BIDMC Comprehensive Headache Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Zaza', 'Initials': 'Z', 'LastName': 'Katsarava', 'Affiliation': 'Evangelical Hospital Unna, Unna, Germany.'}]",The journal of headache and pain,['10.1186/s10194-020-01173-8']
2459,32958076,Effectiveness of a peer-based intervention on loneliness and social isolation of older Chinese immigrants in Canada: a randomized controlled trial.,"BACKGROUND


Social isolation is a key concern for immigrant older adults. We examined the effectiveness of a peer-based intervention in reducing loneliness, social isolation, and improving psychosocial well-being with a sample of aging Chinese immigrants.
METHODS


Sixty community-dwelling older Chinese immigrants aged 65 and older were randomly assigned to an intervention group and a control group (n = 30 each) in a randomized control parallel trial design. Intervention group participants received an eight-week peer support intervention. Twenty-four volunteers aged 48 to 76 engaged in two-on-one peer support through home visits and telephone calls to provide emotional support, problem-solving support, and community resource sharing. Social workers who are not blinded to the group assignment measured the changes of both the intervention group and the control group participants in a range of psychosocial outcomes including three primary outcomes (loneliness, social support, barriers to social participation) and five secondary outcomes (depressive symptoms, anxiety, life satisfaction, happiness, and purpose in life).
RESULTS


The 30 intervention group participants showed a statistically significant decrease in loneliness and increase in resilience when compared to the 30 control group participants. They reported fewer barriers to social participation, fewer depressive symptoms, increased life satisfaction, and happiness while no such improvements were observed in the control group.
CONCLUSIONS


There is a need to further examine the use of peer-based interventions for both program effectiveness and delivery efficiency. In the era of population aging and increasing immigration, diverse aging adults can be trained to fill volunteer support roles via peer-based intervention approaches.
TRIAL REGISTRATION


ISRCTN, ISRCTN14572069 , Registered 23 December 2019 - Retrospectively registered.",2020,The 30 intervention group participants showed a statistically significant decrease in loneliness and increase in resilience when compared to the 30 control group participants.,"['Registered 23 December 2019 - Retrospectively registered', 'older Chinese immigrants in Canada', 'immigrant older adults', 'Twenty-four volunteers aged 48 to 76 engaged in two-on-one peer support through home visits and telephone calls to provide emotional support, problem-solving support, and community resource sharing', 'Sixty community-dwelling older Chinese immigrants aged 65 and older']","['peer-based intervention', 'eight-week peer support intervention']","['loneliness and increase in resilience', 'depressive symptoms, increased life satisfaction, and happiness', 'outcomes (loneliness, social support, barriers to social participation) and five secondary outcomes (depressive symptoms, anxiety, life satisfaction, happiness, and purpose in life', 'loneliness and social isolation']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]",24.0,0.0850471,The 30 intervention group participants showed a statistically significant decrease in loneliness and increase in resilience when compared to the 30 control group participants.,"[{'ForeName': 'Daniel W L', 'Initials': 'DWL', 'LastName': 'Lai', 'Affiliation': 'Faculty of Social Sciences, Hong Kong Baptist University, Hong Kong, China. daniel_lai@hkbu.edu.hk.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Ou', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Celia Y P', 'Initials': 'CYP', 'LastName': 'Li', 'Affiliation': ""The Calgary Chinese Elderly Citizens' Association, Calgary, Canada.""}]",BMC geriatrics,['10.1186/s12877-020-01756-9']
2460,32958156,Multi-Disciplinary Trauma Evaluation and Management Simulation (MD-TEAMS) training for emergency medicine and general surgery residents.,"BACKGROUND


Successful trauma resuscitation relies on multi-disciplinary collaboration. In most academic programs, general surgery (GS) and emergency medicine (EM) residents rarely train together before functioning as a team.
METHODS


In our Multi-Disciplinary Trauma Evaluation and Management Simulation (MD-TEAMS), EM and GS residents completed manikin-based trauma scenarios and were evaluated on resuscitation and communication skills. Residents were surveyed on confidence surrounding training objectives.
RESULTS


Residents showed improved confidence running trauma scenarios in multi-disciplinary teams. Residents received lower communication scores from same-discipline vs cross-discipline faculty. EM residents scored higher in evaluation and planning domains; GS residents scored higher in action processes; groups scored equally in team management. Strong correlation existed between team leader communication and resuscitative skill completion.
CONCLUSION


MD-TEAMS demonstrated correlation between communication and resuscitation checklist item completion and communication differences by resident specialty. In the future, we plan to evaluate training-related resident behavior changes and specialty-specific communication differences by residents.",2020,EM residents scored higher in evaluation and planning domains; GS residents scored higher in action processes; groups scored equally in team management.,['emergency medicine and general surgery residents'],['Multi-Disciplinary Trauma Evaluation and Management Simulation (MD-TEAMS) training'],['confidence running trauma scenarios'],"[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",,0.0370276,EM residents scored higher in evaluation and planning domains; GS residents scored higher in action processes; groups scored equally in team management.,"[{'ForeName': 'Katharine E', 'Initials': 'KE', 'LastName': 'Caldwell', 'Affiliation': 'Department of Surgery, Washington University in St. Louis, St. Louis, MO, United States. Electronic address: kecaldwell@wustl.edu.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Lulla', 'Affiliation': 'Division of Emergency Medicine, Washington University in St. Louis, St. Louis, MO, United States.'}, {'ForeName': 'Collyn T', 'Initials': 'CT', 'LastName': 'Murray', 'Affiliation': 'Division of Emergency Medicine, Washington University in St. Louis, St. Louis, MO, United States.'}, {'ForeName': 'Rahul R', 'Initials': 'RR', 'LastName': 'Handa', 'Affiliation': 'Department of Surgery, Washington University in St. Louis, St. Louis, MO, United States.'}, {'ForeName': 'Ernesto J', 'Initials': 'EJ', 'LastName': 'Romo', 'Affiliation': 'Division of Emergency Medicine, Washington University in St. Louis, St. Louis, MO, United States.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Wagner', 'Affiliation': 'Division of Emergency Medicine, Washington University in St. Louis, St. Louis, MO, United States.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Wise', 'Affiliation': 'Department of Surgery, Washington University in St. Louis, St. Louis, MO, United States.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Leonard', 'Affiliation': 'Department of Surgery, Washington University in St. Louis, St. Louis, MO, United States.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Awad', 'Affiliation': 'Department of Surgery, Washington University in St. Louis, St. Louis, MO, United States.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.09.013']
2461,32958203,Comparison of vasodilatory properties between desflurane and sevoflurane using perfusion index: a randomised controlled trial.,"BACKGROUND


The perfusion index (PI), calculated from the photoplethysmographic waveform, reflects peripheral vasomotor tone. As such, the PI serves as a surrogate for quantitative measures of drug-induced vasoconstriction or vasodilation. This study aimed to compare the effect on the PI of desflurane and sevoflurane at equi-anaesthetic concentrations in patients undergoing single-agent inhalation anaesthesia, where equi-anaesthetic dose was based on the known minimum alveolar concentration of these agents.
METHODS


We randomly allocated patients scheduled for arthroscopic knee surgery to receive either desflurane or sevoflurane general anaesthesia after target-controlled induction of anaesthesia with propofol. Anaesthesia was maintained at age-corrected minimum alveolar concentration 1.0, under neuromuscular block (rocuronium). The PI and haemodynamic data were recorded every minute for 35 min after induction of anaesthesia and after standardised nociceptive stimulation. The primary outcome was PI, compared between the groups over time (repeated-measures analysis of variance). Secondary outcomes included MAP and HR.
RESULTS


Sixty-nine participants (mean [range] age: 42 yr [19-65 yr]; 49% females) were assigned to either desflurane (n=34) or sevoflurane (n=35). The PI remained higher under desflurane compared with sevoflurane, both before (mean difference [MD]: 3.3; 95% confidence intervals [CIs]: 2.0-4.7; P<0.001) and after tetanic stimulation (MD: 2.8; 95% CI: 2.0-3.7; P<0.001). Higher PI paralleled lower MAP in participants assigned to desflurane anaesthesia (P<0.001), both before (MD: 8 mm Hg; 95% CI: 4-12) and after nociceptive stimulation (MD: 14 mm Hg; 95% CI: 7-22). HR was similar throughout.
CONCLUSIONS


These findings suggest that at equipotent doses, desflurane exerts more potent vasodilatory properties and lowers blood pressure by a magnitude potentially associated with harm.
CLINICAL TRIAL REGISTRATION


NCT03570164.",2020,"Higher PI paralleled lower MAP in participants assigned to desflurane anaesthesia (P<0.001), both before (MD: 8 mm Hg; 95% CI: 4-12) and after nociceptive stimulation (MD: 14 mm Hg; 95% CI: 7-22).","['patients undergoing single-agent inhalation anaesthesia', 'Sixty-nine participants (mean [range] age: 42 yr [19-65 yr]; 49% females']","['arthroscopic knee surgery', 'desflurane and sevoflurane', 'propofol', 'desflurane or sevoflurane general anaesthesia', 'desflurane anaesthesia', 'desflurane', 'sevoflurane']","['PI and haemodynamic data', 'MAP and HR', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4082765', 'cui_str': 'Arthroscopic knee operation'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C2964282', 'cui_str': 'Perfusion Index'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.368602,"Higher PI paralleled lower MAP in participants assigned to desflurane anaesthesia (P<0.001), both before (MD: 8 mm Hg; 95% CI: 4-12) and after nociceptive stimulation (MD: 14 mm Hg; 95% CI: 7-22).","[{'ForeName': 'Kyoung-Ho', 'Initials': 'KH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Ha', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae-Geum', 'Initials': 'JG', 'LastName': 'Shim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Eun-Ah', 'Initials': 'EA', 'LastName': 'Cho', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: hoho4321.lee@daum.net.'}, {'ForeName': 'Jae-Hoon', 'Initials': 'JH', 'LastName': 'Byun', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.07.050']
2462,32958269,Water only fasting and its effect on chemotherapy administration in gynecologic malignancies.,"OBJECTIVE


As a protective response, during starvation organisms withdraw energy from growth and reproduction to focus on cellular maintenance. Cancer cells cannot undergo this differential response which has been theorized as an adjunct to improve both the effect of chemotherapy treatment and reduce treatment side effects. We sought to investigate the feasibility and effect of short-term fasting in patients receiving chemotherapy for gynecologic malignancy.
METHODS


A randomized control trial was conducted of women with gynecologic malignancies receiving at least 6 planned chemotherapy cycles. Fasting patients maintaining a water-only fast for 24 h before and 24 h following each chemotherapy cycle were compared to nonfasting patients. Treatment related side effects and quality of life (QOL) was assessed using NCCN-FACT FOSI-18 questionnaire.
RESULTS


Analysis included data from 120 cycles of chemotherapy. The majority of patients had stage 3 and 4 malignancy requiring multi-agent chemotherapy. Eleven patients had ovarian, 8 had uterine, and 1 had cervical cancer. Ninety percent received taxane and platinum-based doublet therapy. Weight loss and unanticipated hospitalizations were similar between treatment groups. Fewer dose reductions or delays were seen in the fasting group. There was no significant difference in mean QOL scores, but fasting group QOL scores improved over the course of treatment to a level that reached the minimal clinically important difference.
CONCLUSION


A 48-h fast is well tolerated without increasing weight loss, hospital admissions, or chemotherapy dose reduction/delays. Fasting resulted in fewer treatment modifications and improved quality of life scores over the course of treatment.",2020,"There was no significant difference in mean QOL scores, but fasting group QOL scores improved over the course of treatment to a level that reached the minimal clinically important difference.
","['Eleven patients had ovarian, 8 had uterine, and 1 had cervical cancer', 'women with gynecologic malignancies receiving at least 6 planned chemotherapy cycles', 'patients had stage 3 and 4 malignancy requiring multi-agent chemotherapy', 'gynecologic malignancies', 'patients receiving chemotherapy for gynecologic malignancy']",['taxane and platinum-based doublet therapy'],"['Weight loss and unanticipated hospitalizations', 'mean QOL scores', 'side effects and quality of life (QOL', 'QOL scores', 'quality of life scores']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0594678,"There was no significant difference in mean QOL scores, but fasting group QOL scores improved over the course of treatment to a level that reached the minimal clinically important difference.
","[{'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Riedinger', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tennessee at Knoxville Graduate School of Medicine, 1924 Alcoa Highway, Box U-27 Knoxville, Tennessee 37920, United States of America. Electronic address: CRiedinger@utmck.edu.'}, {'ForeName': 'Kristopher J', 'Initials': 'KJ', 'LastName': 'Kimball', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tennessee at Knoxville Graduate School of Medicine, 1924 Alcoa Highway, Box U-27 Knoxville, Tennessee 37920, United States of America.'}, {'ForeName': 'Larry C', 'Initials': 'LC', 'LastName': 'Kilgore', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tennessee at Knoxville Graduate School of Medicine, 1924 Alcoa Highway, Box U-27 Knoxville, Tennessee 37920, United States of America.'}, {'ForeName': 'Clayton W', 'Initials': 'CW', 'LastName': 'Bell', 'Affiliation': 'Department of Family Medicine, University of Tennessee at Knoxville Graduate School of Medicine, UT Internal Medicine & Integrated Health1932 Alcoa Highway, Ste C-470 Knoxville, TN 37920, United States of America.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Heidel', 'Affiliation': 'Department of Surgery, University of Tennessee at Knoxville Graduate School of Medicine, l924 Alcoa Highway, Box U-11, Knoxville, Tennessee 37920-6999, United States of America.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Boone', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tennessee at Knoxville Graduate School of Medicine, 1924 Alcoa Highway, Box U-27 Knoxville, Tennessee 37920, United States of America.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.008']
2463,32958299,Re: Thulium Laser Transurethral Vaporesection of the Prostate Versus Transurethral Resection of the Prostate for Men with Lower Urinary Tract Symptoms or Urinary Retention (UNBLOCS): A Randomized Controlled Trial.,,2020,,['Men with Lower Urinary Tract Symptoms or Urinary Retention (UNBLOCS'],['Laser Transurethral Vaporesection of the Prostate Versus Transurethral Resection of the Prostate'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]",[],,0.036213,,"[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Enikeev', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia. Electronic address: dvenikeev@gmail.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Taratkin', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Glybochko', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}]",European urology,['10.1016/j.eururo.2020.09.011']
2464,32958311,Rapid nutritional assessment and intervention in orthopedic rehabilitation patients.,"OBJECTIVES


The aim of this study was to identify the effect of early nutritional assessment and nutritional intervention on outcomes of older adult patients after discharge from an acute care hospital following fall related fracture.
METHODS


This was a feasibility pilot study with post intervention data. One group pretest-posttest study design was implemented. All participants were admitted to a rehabilitation facility in the Southwestern US after a fall related fracture.
MEASURES


Discharge destination, Functional Independence Measure (FIM), and length of stay (LOS).
RESULTS


A total of 69% of the participants were discharged home. Total FIM scores improved (p<0.01). No significant association was identified between prealbumin change and total FIM change. Patients who had improved prealbumin experienced improved FIM and shorter LOS; however, no significant correlations were determined between LOS and prealbumin change.
CONCLUSION


Nutritional interventions are important for recovery during rehabilitation of a fall-related fracture.
SUMMARY


This project supports early nutritional evaluation and intervention for older adult patients after major orthopedic procedure. Participants who received early intervention had improved outcomes. (194 characters).",2020,Total FIM scores improved (p<0.01).,"['All participants were admitted to a rehabilitation facility in the Southwestern US after a fall related fracture', 'older adult patients after discharge from an acute care hospital following fall related fracture', 'orthopedic rehabilitation patients', 'older adult patients after major orthopedic procedure']",['early nutritional assessment and nutritional intervention'],"['Total FIM scores', 'LOS and prealbumin change', 'Discharge destination, Functional Independence Measure (FIM), and length of stay (LOS', 'prealbumin change and total FIM change', 'FIM and shorter LOS']","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3845566', 'cui_str': 'Rehabilitation facility'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0524852', 'cui_str': 'Orthopaedic procedure'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0028708', 'cui_str': 'Assessment of nutritional status'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4274266', 'cui_str': 'Functional Independence Measure score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",,0.0189037,Total FIM scores improved (p<0.01).,"[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Niyati', 'Affiliation': 'College of Nursing and Health Innovation, University of Texas at Arlington, 411 S. Nedderman, Box 19407, Arlington, TX 76019, USA.'}, {'ForeName': 'Zara', 'Initials': 'Z', 'LastName': 'Sajwani', 'Affiliation': 'College of Nursing and Health Innovation, University of Texas at Arlington, 411 S. Nedderman, Box 19407, Arlington, TX 76019, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Daniel', 'Affiliation': 'College of Nursing and Health Innovation, University of Texas at Arlington, 411 S. Nedderman, Box 19407, Arlington, TX 76019, USA. Electronic address: kdaniel@uta.edu.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.09.001']
2465,32958495,"Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults.","INTRODUCTION


To find effective and safe treatments for COVID-19, the WHO recommended to systemically evaluate experimental therapeutics in collaborative randomised clinical trials. As COVID-19 was spreading in Europe, the French national institute for Health and Medical Research (Inserm) established a transdisciplinary team to develop a multi-arm randomised controlled trial named DisCoVeRy. The objective of the trial is to evaluate the clinical efficacy and safety of different investigational re-purposed therapeutics relative to Standard of Care (SoC) in patients hospitalised with COVID-19.
METHODS AND ANALYSIS


DisCoVeRy is a phase III, open-label, adaptive, controlled, multicentre clinical trial in which hospitalised patients with COVID-19 in need of oxygen therapy are randomised between five arms: (1) a control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β-1a + SoC and (5) hydroxychloroquine + SoC. The primary endpoint is the clinical status at Day 15 on the 7-point ordinal scale of the WHO Master Protocol (V.3.0, 3 March 2020). This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe. A sample size of 3100 patients (620 patients per arm) is targeted. This trial has begun on 22 March 2020. Since 5 April 2020, DisCoVeRy has been an add-on trial of the Solidarity consortium of trials conducted by the WHO in Europe and worldwide. On 8 June 2020, 754 patients have been included.
ETHICS AND DISSEMINATION


Inserm is the sponsor of DisCoVeRy. Ethical approval has been obtained from the institutional review board on 13 March 2020 (20.03.06.51744) and from the French National Agency for Medicines and Health Products (ANSM) on 9 March 2020. Results will be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04315948 Eudra-CT 2020-000936-23.",2020,This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe.,"['hospitalised patients with COVID-19 in need of oxygen therapy', '3100 patients (620 patients per arm) is targeted', 'On 8 June 2020, 754 patients have been included', 'hospitalised adults', 'patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe', 'patients hospitalised with COVID-19']","['investigational re-purposed therapeutics relative to Standard of Care (SoC', 'control group managed with SoC and four therapeutic arms with re-purposed antiviral agents: (2) remdesivir + SoC, (3) lopinavir/ritonavir + SoC, (4) lopinavir/ritonavir associated with interferon (IFN)-β-1a + SoC and (5) hydroxychloroquine + SoC']","['clinical efficacy and safety', 'clinical status at Day 15 on the 7-point ordinal scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C4517705', 'cui_str': '3100'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",3100.0,0.254259,This trial involves patients hospitalised in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe.,"[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Ader', 'Affiliation': 'Infectious and tropical diseases department, Centre Hospitalier Universitaire de Lyon, F-69004 Lyon, and Inserm 1111-Centre International de Recherche en Infectiologie (CIRI), Université Claude Bernard Lyon 1, CNRS, UMR5308, Ecole Normale Supérieure de Lyon, Univ Lyon, F-69007, Lyon, France florence.ader@chu-lyon.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-041437']
2466,32958502,Short-term efficacy of home-based heart rate variability biofeedback on sleep disturbance in patients with incurable cancer: a randomised open-label study.,"OBJECTIVES


Early palliative care reportedly contributes to the quality of life by improving coping skills in patients with cancer. The aims of the study are to (1) Build a self-coping system that makes it possible to perform a session of home-based heart rate variability biofeedback (HRV-BF) with resonant breathing in patients with sleep disturbance and to acquire its techniques early on, and (2) Examine its short-term efficacy and feasibility.
METHODS


A randomised, open-label, comparative study was conducted in the presence or absence of home-based HRV-BF with resonant breathing using a portable HRV-BF device prior to bedtime. The participants were 50 patients with incurable cancer with sleep disturbance who underwent a hospital practice of HRV-BF with resonant breathing. The primary end point was the rate of change in sleep efficiency for 10-14 days. The Japanese version of the Pittsburgh Sleep Quality Index (subjective indicator) and actigraphy sleep parameters (objective indicators) were used for sleep assessments.
RESULTS


The completion rate and implementation rate in the home-based HRV-BF group (n=25) were 96.0% and 91.4%, respectively. This group showed a significant improvement in sleep efficiency, sleep duration and the low-frequency component of HRV. Sleep latency worsened in this group, but a significant difference was not observed.
CONCLUSIONS


A home practice of HRV-BF with resonant breathing made it possible to acquire its techniques early on and improve sleep and autonomic function; therefore, our study showed high short-term efficacy and feasibility required for a self-coping system.",2020,"This group showed a significant improvement in sleep efficiency, sleep duration and the low-frequency component of HRV.","['50 patients with incurable cancer with sleep disturbance who underwent a hospital practice of HRV-BF with resonant breathing', 'patients with incurable cancer', 'patients with sleep disturbance', 'patients with cancer']","['biofeedback', 'home-based heart rate variability biofeedback (HRV-BF) with resonant breathing', 'home-based HRV-BF with resonant breathing using a portable HRV-BF device prior to bedtime']","['completion rate and implementation rate', 'sleep efficiency, sleep duration and the low-frequency component of HRV', 'Sleep latency', 'Pittsburgh Sleep Quality Index (subjective indicator) and actigraphy sleep parameters (objective indicators', 'sleep disturbance', 'rate of change in sleep efficiency', 'heart rate variability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0225810', 'cui_str': 'Structure of base of heart'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0179310', 'cui_str': 'Biofeedback system'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",50.0,0.0163213,"This group showed a significant improvement in sleep efficiency, sleep duration and the low-frequency component of HRV.","[{'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Hasuo', 'Affiliation': 'Psychosomatic Medicine, Kansai Medical University, Hirakata, Osaka, Japan hasuohid@hirakata.kmu.ac.jp.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kanbara', 'Affiliation': 'Psychosomatic Medicine, Kansai Medical University, Hirakata, Osaka, Japan.'}, {'ForeName': 'Hisaharu', 'Initials': 'H', 'LastName': 'Shizuma', 'Affiliation': 'Psychosomatic Medicine, Kansai Medical University, Hirakata, Osaka, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Morita', 'Affiliation': 'Psychosomatic Medicine, Kansai Medical University, Hirakata, Osaka, Japan.'}, {'ForeName': 'Mikihiko', 'Initials': 'M', 'LastName': 'Fukunaga', 'Affiliation': 'Psychosomatic Medicine, Kansai Medical University, Hirakata, Osaka, Japan.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002324']
2467,32958537,The cost-effectiveness of using performance-based financing to deliver the basic package of health services in Afghanistan.,"Performance-based financing (PBF) is a mechanism to improve the quality and the utilisation of health benefit packages. There is a dearth of economic evaluations of PBF in the 'real world'. Afghanistan implemented PBF between 2010 and 2015 and evaluated the programme using a pragmatic cluster-randomised control trial. We conducted a cost-effectiveness analysis of the PBF programme in Afghanistan, compared with the standard of care, from the provider payer's perspective. The incremental cost-effectiveness ratio of PBF compared with the standard of care was US$1242 per disability-adjusted life year averted; not cost-effective when compared with an opportunity cost threshold of US$349. Incentive payments were the main contributor to PBF financial cost (70%) followed by data verification (23%), staff time (5%) and administration (2%). The unit cost per case of antenatal care (ANC), skilled birth attendance (SBA) and postnatal care (PNC) services in the standard of care was US$0.96 (95% CI 0.92-1.0), US$4.8 (95% CI 4.1-6.3) and US$1.3 (95% CI 1.2-1.4), respectively, whereas the cost of ANC, SBA and PNC services per case in PBF areas were US$4.72 (95% CI 4.68-5.7), US$48.5 (95% CI 48.0-52.5) and US$5.4 (95% CI 5.1-5.9), respectively. To conclude, our study found that PBF, as implemented in the Afghan context, was not the best use of funds to strengthen the delivery of maternal and child health services. The cost-effectiveness of alternative PBF designs needs to be appraised before using PBF at scale to support health benefit packages. PBF needs to be considered in the context of funding the range of constraints that inhibit health service performance improvement.",2020,"Incentive payments were the main contributor to PBF financial cost (70%) followed by data verification (23%), staff time (5%) and administration (2%).",['Afghanistan'],"['PBF programme', 'Performance-based financing (PBF']","['cost-effectiveness', 'unit cost per case of antenatal care (ANC), skilled birth attendance (SBA) and postnatal care (PNC) services', 'staff time', 'incremental cost-effectiveness ratio of PBF', 'cost of ANC, SBA and PNC services per case in PBF areas', 'PBF financial cost']","[{'cui': 'C0001732', 'cui_str': 'Afghanistan'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243097', 'cui_str': 'financing'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0376243', 'cui_str': 'finances'}]",,0.0615825,"Incentive payments were the main contributor to PBF financial cost (70%) followed by data verification (23%), staff time (5%) and administration (2%).","[{'ForeName': 'Ahmad S', 'Initials': 'AS', 'LastName': 'Salehi', 'Affiliation': 'Department of Global Health Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, London, UK ahmad.salehi@lshtm.ac.uk.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Borghi', 'Affiliation': 'Department of Global Health Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Blanchet', 'Affiliation': 'Centre for Education and Research in Humanitarian Action (CERAH), University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vassall', 'Affiliation': 'Department of Global Health Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, London, UK.'}]",BMJ global health,['10.1136/bmjgh-2020-002381']
2468,32958583,Proof of concept of a personalized genetic risk tool to promote smoking cessation: High acceptability and reduced cigarette smoking.,"Relatively little is known about the possible effects of personalized genetic risk information on smoking, the leading preventable cause of morbidity and mortality. We examined the acceptability and potential behavior change associated with a personalized genetically-informed risk tool (RiskProfile) among current smokers. Current smokers (n=108) were enrolled in a pre-post study with three visits. At Visit 1, participants completed a baseline assessment and genetic testing via 23andMe. Participants' raw genetic data (CHRNA5 variants) and smoking heaviness were used to create a tailored RiskProfile tool that communicated personalized risks of smoking-related diseases and evidence-based recommendations to promote cessation. Participants received their personalized RiskProfile intervention at Visit 2, approximately 6 weeks later. Visit 3 involved a telephone-based follow-up assessment 30 days after intervention. Of enrolled participants, 83% were retained across the three visits. Immediately following intervention, acceptability of RiskProfile was high (M=4.4; SD=0.6 on scale of 1 to 5); at 30-day follow-up, 89% of participants demonstrated accurate recall of key intervention messages. In the full analysis set of this single-arm trial, cigarettes smoked per day decreased from intervention to 30-day follow-up [11.3 vs. 9.8, difference=1.5, 95% CI (0.6-2.4), p=.001]. A personalized genetically-informed risk tool was found to be highly acceptable and associated with a reduction in smoking, although the absence of a control group must be addressed in future research. This study demonstrates proof of concept for translating key basic science findings into a genetically-informed risk tool that was used to promote progress toward smoking cessation.",2020,"Immediately following intervention, acceptability of RiskProfile was high (M=4.4; SD=0.6 on scale of 1 to 5); at 30-day follow-up, 89% of participants demonstrated accurate recall of key intervention messages.","[""Participants' raw genetic data (CHRNA5 variants) and smoking heaviness"", 'Current smokers (n=108) were enrolled in a pre-post study with three visits', 'current smokers']","['personalized genetically-informed risk tool (RiskProfile', 'personalized RiskProfile intervention']","['acceptability and potential behavior change', 'acceptability of RiskProfile']","[{'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]",108.0,0.0315177,"Immediately following intervention, acceptability of RiskProfile was high (M=4.4; SD=0.6 on scale of 1 to 5); at 30-day follow-up, 89% of participants demonstrated accurate recall of key intervention messages.","[{'ForeName': 'Alex T', 'Initials': 'AT', 'LastName': 'Ramsey', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis School of Medicine aramsey@wustl.edu.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Bourdon', 'Affiliation': 'Brown School of Social Work; Department of Psychiatry, Washington University in St. Louis School of Medicine.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bray', 'Affiliation': 'Psychiatry, Washington University in St. Louis School of Medicine.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Dorsey', 'Affiliation': 'Psychiatry, Washington University in St. Louis School of Medicine.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Zalik', 'Affiliation': 'Washington University in St. Louis School of Medicine.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Pietka', 'Affiliation': 'Washington University in St. Louis School of Medicine.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Salyer', 'Affiliation': 'Washington University in St. Louis School of Medicine.'}, {'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Washington University in St. Louis.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Public Health, University of Wisconsin-Madison School of Medicine and Public Health.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafo', 'Affiliation': 'Experimental Psychology, University of Bristol.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': 'Psychiatry, Washington University in St. Louis School of Medicine.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0328']
2469,32958718,"A prospective, randomized, open-label trial of early versus late favipiravir in hospitalized patients with COVID-19.","Favipiravir is an oral broad-spectrum inhibitor of viral RNA-dependent RNA polymerase that is approved for treatment of influenza in Japan. We conducted a prospective, randomized, open-label, multicenter trial of favipiravir for the treatment of COVID-19 at 25 hospitals across Japan. Eligible patients were adolescents and adults admitted with COVID-19 who were asymptomatic or mildly ill and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients were randomly assigned at a 1:1 ratio to early or late favipiravir therapy (the same regimen starting on day 6 instead of day 1). The primary endpoint was viral clearance by day 6. The secondary endpoint was change in viral load by day 6. Exploratory endpoints included time to defervescence and resolution of symptoms. Eighty-nine patients were enrolled, of whom 69 were virologically evaluable. Viral clearance occurred within 6 days in 66.7% and 56.1% of the early and late treatment groups (adjusted hazard ratio [aHR], 1.42; 95% confidence interval [95% CI], 0.76-2.62). Of 30 patients who had a fever (≥37.5°C) on day 1, time to defervescence was 2.1 days and 3.2 days in the early and late treatment groups (aHR, 1.88; 95%CI, 0.81-4.35). During therapy, 84.1% developed transient hyperuricemia. Favipiravir did not significantly improve viral clearance as measured by RT-PCR by day 6 but was associated with numerical reduction in time to defervescence. Neither disease progression nor death occurred to any of the patients in either treatment group during the 28-day participation (Japan Registry of Clinical Trials jRCTs041190120).",2020,Favipiravir did not significantly improve viral clearance as measured by RT-PCR by day 6 but was associated with numerical reduction in time to defervescence.,"['COVID-19 at 25 hospitals across Japan', 'influenza in Japan', 'Eligible patients were adolescents and adults admitted with COVID-19 who were asymptomatic or mildly ill and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1', '30 patients who had a fever (≥37.5°C) on day 1', 'Eighty-nine patients were enrolled, of whom 69 were virologically evaluable', 'hospitalized patients with COVID-19']","['favipiravir', 'Favipiravir', 'late favipiravir therapy']","['transient hyperuricemia', 'viral clearance', 'time to defervescence and resolution of symptoms', 'Viral clearance', 'time to defervescence', 'change in viral load', 'disease progression nor death']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",89.0,0.103757,Favipiravir did not significantly improve viral clearance as measured by RT-PCR by day 6 but was associated with numerical reduction in time to defervescence.,"[{'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Doi', 'Affiliation': 'Departments of Microbiology and Infectious Diseases, Fujita Health University School of Medicine, Toyoake, Aichi, Japan yoheidoi@fujita-hu.ac.jp.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Hibino', 'Affiliation': 'Department of Emergency and General Internal Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Hase', 'Affiliation': 'Department of Infectious Diseases, Japanese Red Cross Narita Hospital, Narita, Chiba, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Respiratory Medicine, Sagamihara Kyodo Hospital, Sagamihara, Kanagawa, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kasamatsu', 'Affiliation': 'Infection Control and Clinical Laboratory, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Hirose', 'Affiliation': 'Department of Respiratory Medicine, Fujita Health University Bantane Hospital, Nagoya, Aichi, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Mutoh', 'Affiliation': 'Department of Infectious Diseases, Tosei General Hospital, Seto, Aichi, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Homma', 'Affiliation': 'Department of Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Terada', 'Affiliation': 'Department of Respiratory Medicine, Saiseikai Niigata Hospital, Niigata, Niigata, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Center for Infectious Diseases, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Fumihiro', 'Initials': 'F', 'LastName': 'Kashizaki', 'Affiliation': 'Department of Respiratory Medicine, Isehara Kyoto Hospital, Isehara, Kanagawa, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Respiratory Medicine, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Aichi, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Koba', 'Affiliation': 'Department of Respiratory Medicine, Komatsu Municipal Hospital, Komatsu, Ishikawa, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Kasahara', 'Affiliation': 'Department of Rheumatology, NTT East Sapporo Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Yokota', 'Affiliation': 'Department of Infectious Diseases, Tokyo Metropolitan Health and Medical Corporation Ebara Hospital, Ohta, Tokyo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Infection Prevention and Control Department, Yokohama City University Hospital, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yoshida', 'Affiliation': 'Department of Chest Surgery, Shimonoseki City Hospital, Shimonoseki, Yamaguchi, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kita', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Kanazawa Medical Center, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Department of Infectious Diseases, International University of Health and Welfare Narita Hospital, Narita, Chiba, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kamio', 'Affiliation': 'Department of Intensive Care, Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Kodama', 'Affiliation': 'Department of General Internal Medicine, Fukuoka Tokushukai Hospital, Kasuga, Fukuoka, Japan.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Department of General Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Ikeda', 'Affiliation': 'Department of General Internal Medicine, Eiju General Hospital, Taito, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shinoda', 'Affiliation': 'Department of Respiratory Medicine, Tokyo Shinagawa Hospital, Shinagawa, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Nakatsumi', 'Affiliation': 'Department of Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Horiguchi', 'Affiliation': 'Department of Respiratory Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mitsunaga', 'Initials': 'M', 'LastName': 'Iwata', 'Affiliation': 'Department of Emergency and General Internal Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Akifumi', 'Initials': 'A', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Regenerative Medicine and Stem Cell Biology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Sumi', 'Initials': 'S', 'LastName': 'Banno', 'Affiliation': 'Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Takenao', 'Initials': 'T', 'LastName': 'Koseki', 'Affiliation': 'Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Teramachi', 'Affiliation': 'Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Miyata', 'Affiliation': 'Center for Clinical Trial and Research Support, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Tajima', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Maeki', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Nakayama', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Chang Kweng', 'Initials': 'CK', 'LastName': 'Lim', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Saijo', 'Affiliation': 'Department of Virology I, National Institute of Infectious Diseases, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Osaka, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Osaka, Japan.'}, {'ForeName': 'Daijiro', 'Initials': 'D', 'LastName': 'Kabata', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Osaka, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Shintani', 'Affiliation': 'Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Osaka, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Yuzawa', 'Affiliation': 'Department of Nephrology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Respiratory Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01897-20']
2470,32958820,Chemoradiotherapy with extended nodal irradiation and/or erlotinib in locally advanced oesophageal squamous cell cancer: long-term update of a randomised phase 3 trial.,"BACKGROUND


To report the long-term outcomes of a phase III trial designed to test two hypotheses: (1) elective nodal irradiation (ENI) is superior to conventional field irradiation (CFI), and (2) chemoradiotherapy plus erlotinib is superior to chemoradiotherapy in locally advanced oesophageal squamous cell cancer (ESCC).
METHODS


Patients with locally advanced ESCC were randomly assigned (1:1:1:1 ratio) to one of the four groups: A: radiotherapy adoption of ENI with two cycles of concurrent TP chemotherapy (paclitaxel and cisplatin) plus erlotinib; B: radiotherapy adoption of ENI with two cycles of concurrent TP; C: radiotherapy adoption of CFI with two cycles of concurrent TP plus erlotinib and D: radiotherapy adoption of CFI with two cycles of concurrent TP. A total of 60 Gy of radiation doses was delivered over 30 fractions. We explored the impact of epidermal growth factor receptor (EGFR) expression on the efficacy of erlotinib plus chemoradiotherapy.
RESULTS


A total of 352 patients (88 assigned to each treatment group) were enrolled. The 5-year survival rates were 44.9%, 34.8%, 33.8% and 19.6% in groups A, B, C and D, respectively (P = 0.013). ENI significantly improved OS compared with standard CFI (median, 38.5 vs 22.6 months; HR, 0.74; P = 0.018). The addition of erlotinib significantly improved OS (median, 39.4 vs 27.4 months; HR, 0.75; P = 0.025). Patients with overexpressing EGFR treated with erlotinib had a better OS and PFS than those without erlotinib.
CONCLUSIONS


Concurrent chemoradiotherapy with ENI and/or erlotinib improved long-term survival in locally advanced ESCC.
CLINICAL TRIAL REGISTRATION


Trial registration: NCT00686114.",2020,"ENI significantly improved OS compared with standard CFI (median, 38.5 vs 22.6 months; HR, 0.74; P = 0.018).","['locally advanced oesophageal squamous cell cancer (ESCC', '352 patients (88 assigned to each treatment group) were enrolled', 'Patients with locally advanced ESCC', 'Patients with overexpressing EGFR treated with', 'locally advanced oesophageal squamous cell cancer']","['conventional field irradiation (CFI), and (2) chemoradiotherapy plus erlotinib', 'Chemoradiotherapy with extended nodal irradiation and/or erlotinib', 'concurrent TP chemotherapy (paclitaxel and cisplatin) plus erlotinib', 'erlotinib', 'erlotinib plus chemoradiotherapy', 'chemoradiotherapy with ENI', 'elective nodal irradiation (ENI', 'concurrent TP plus erlotinib and D: radiotherapy']","['long-term survival', '5-year survival rates', 'OS', 'OS and PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",352.0,0.204383,"ENI significantly improved OS compared with standard CFI (median, 38.5 vs 22.6 months; HR, 0.74; P = 0.018).","[{'ForeName': 'Congying', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Radiation and Medical Oncology, Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Jing', 'Affiliation': 'Department of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Honglei', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ""Department of Radiation Oncology, No. 1 People's Hospital of Huaian, Huaian, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, 518116, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, 518116, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Radiation Oncology, Taizhou Hospital of Zhejiang Province, Linhai, China.'}, {'ForeName': 'Anping', 'Initials': 'A', 'LastName': 'Zheng', 'Affiliation': 'Department of Radiation Oncology, Anyang Cancer Hospital, Anyang, China.'}, {'ForeName': 'Duojie', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Lingyu', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Medical Oncology, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Anhui Provincial Hospital, Anhui, China.'}, {'ForeName': 'Conghua', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Radiation Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xilong', 'Initials': 'X', 'LastName': 'Lian', 'Affiliation': 'Department of Radiation Oncology, Kaohsiung Medical University Hospital Cancer Centre, Kaohsiung, Taiwan.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Du', 'Affiliation': 'Department of Radiation Oncology, Central Hospital of Lishui City, Lishui, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Bian', 'Affiliation': 'Department of Radiation Oncology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Bangxian', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Department of Radiation Oncology, Affiliated Hospital of North Sichuan Medical College, Nanchong, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xia', 'Affiliation': 'Department of Radiation Oncology, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ruifei', 'Initials': 'R', 'LastName': 'Xie', 'Affiliation': 'Department of Biostatistics, Hangzhou Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, Sun Yat-Sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Lvhua', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, 518116, China. wlhwq@yahoo.com.'}, {'ForeName': 'Shixiu', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, 518116, China. wushixiu@medmail.com.cn.'}]",British journal of cancer,['10.1038/s41416-020-01054-6']
2471,32959110,"The impact of acetylsalicylic acid dosed at bedtime on circadian rhythms of blood pressure in the high-risk group of cardiovascular patients-a randomized, controlled trial.","PURPOSE


Time of drug administration may significantly influence its effect. The aim of the present study was to investigate the effect of ASA (administrated in the morning or in the evening) on the anti-hypertensive effect and diurnal blood pressure profile in the high-risk group of cardiovascular patients.
METHODS


All patients (n = 114) had been diagnosed with coronary heart disease and arterial hypertension prior to the enrolment and had been treated with 75 mg per day of ASA in the morning. The patients were randomly assigned to one of the two study groups receiving 75 mg of ASA per day in a single antiplatelet therapy for 3 months in the morning (n = 58) or in the evening (n = 56). The control group (n = 61) consisted of patients with arterial hypertension but without coronary heart disease, not receiving ASA. In all the patients, during each visit, clinical blood pressure (BP) and ambulatory blood pressure measurements (ABPM) were performed.
RESULTS


There was a significant reduction in 24-h BP and blood pressure at night in the ASA group evening group compared with the ASA morning group and the control group.
CONCLUSIONS


The present study demonstrated that compared with the use of ASA in the morning, its administration in the evening may lead to favourable drop in the ABPM and an improvement of the diurnal profile in the high-risk group of cardiovascular patients who are not naïve to ASA.",2020,"There was a significant reduction in 24-h BP and blood pressure at night in the ASA group evening group compared with the ASA morning group and the control group.
","['high-risk group of cardiovascular patients', 'patients with arterial hypertension but without coronary heart disease, not receiving ASA', 'All patients (n\u2009=\u2009114) had been diagnosed with coronary heart disease and arterial hypertension prior to the enrolment and had been treated with 75\xa0mg per day of ASA in the morning']","['acetylsalicylic acid', 'ASA', 'receiving 75\xa0mg of ASA']","['24-h BP and blood pressure', 'clinical blood pressure (BP) and ambulatory blood pressure measurements (ABPM', 'circadian rhythms of blood pressure', 'diurnal blood pressure profile']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332170', 'cui_str': 'Morning'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}]",,0.0789838,"There was a significant reduction in 24-h BP and blood pressure at night in the ASA group evening group compared with the ASA morning group and the control group.
","[{'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Krasińska', 'Affiliation': 'Department of Hypertension, Angiology and Internal Diseases, Poznan University of Medical Sciences, Długa 1/2, 61-848, Poznań, Poland. beata.bkrasinska@gmail.com.'}, {'ForeName': 'Lech', 'Initials': 'L', 'LastName': 'Paluszkiewicz', 'Affiliation': 'Department of Thoracic And Cardiovascular Surgery/Perioperative diagnostics Bad Oeynhausen, Heart and Diabetes Center NRW, Ruhr-University of Bochum, Bochum, Germany.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Miciak-Ławicka', 'Affiliation': 'Department of Hypertension, Angiology and Internal Diseases, Poznan University of Medical Sciences, Długa 1/2, 61-848, Poznań, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Krasinski', 'Affiliation': 'Imperial College London School of Medicine, London, UK.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rzymski', 'Affiliation': 'Department of Environmental Medicine, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Tykarski', 'Affiliation': 'Department of Hypertension, Angiology and Internal Diseases, Poznan University of Medical Sciences, Długa 1/2, 61-848, Poznań, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Krasiński', 'Affiliation': 'Department of General and Vascular Surgery, Poznan University of Medical Sciences, Poznan, Poland.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02997-8']
2472,32959182,"Comparison of two-dimensional high-definition, ultra high-definition and three-dimensional endovision systems: an ex-vivo randomised study.","BACKGROUND


Two-dimensional high-definition (2D HD) endovision system is preferred for laparoscopic surgery. Recently, new generation three-dimensional (3D) HD and ultra-HD (4K) endovision systems are introduced to improve the safety and efficacy of laparoscopic surgery. There is limited evidence on superiority of one technology over the others. This experimental trial was designed to evaluate 2D HD, 3D HD and 4K HD endovision systems in performance of standardized tasks.
METHODS


This was a randomized, cross-over experimental study. Twenty-one surgical residents who were exposed to laparoscopic surgery were enrolled. Participants were randomly assigned into three groups. Each group performed standardised tasks i.e. peg transfer, precision cutting, navigating in space and intra-corporeal suturing using 2D HD, 4K HD and 3D HD endovision systems on a box trainer. Procedures were recorded as 2D HD videos and analysed later. Participant's perceived workload was assessed using Surg-TLX questionnaire. Primary endpoints were execution time in seconds and error score. Secondary endpoint was workload assessment.
RESULTS


The 3D HD had shorter execution time compared to 2D HD and 4K HD in all tasks except precision cutting (p = 0.004, 0.03, 0.001, 0.001 and p = 0.002, 0.191, 0.006, 0.005 in peg transfer, precision cutting, navigating in space and intra-corporeal suturing respectively). The 4K HD was significantly faster than 2D HD only in navigating in space task (p = 0.002). The error score between 3D HD and 4K HD were comparable in all tasks. The 2D HD had significantly more error scores compared to 4K HD, 3D HD in peg transfer task (p = 0.005, 0.014, respectively). 3D HD had significantly less workload than 2D HD and 4K HD in most of the dimensions of Surg-TLX CONCLUSIONS: 3D HD endovision system in comparison to 2D HD and 4K HD, may lead to faster execution without compromising safety of a task and is associated with less workload.",2020,Each group performed standardised tasks,['Twenty-one surgical residents who were exposed to laparoscopic surgery were enrolled'],['standardised tasks'],"['execution time in seconds and error score', 'shorter execution time', 'error score between 3D HD and 4K HD', 'workload assessment', 'error scores']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]",[],"[{'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",21.0,0.0370364,Each group performed standardised tasks,"[{'ForeName': 'Hemanga K', 'Initials': 'HK', 'LastName': 'Bhattacharjee', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India. dr_hkb75@yahoo.com.'}, {'ForeName': 'Shafneed', 'Initials': 'S', 'LastName': 'Chaliyadan', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Ashwani K', 'Initials': 'AK', 'LastName': 'Mishra', 'Affiliation': 'National Drug Dependence Treatment Centre (NDDTC), All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Harshit', 'Initials': 'H', 'LastName': 'Agarwal', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Suhani', 'Initials': 'S', 'LastName': 'Suhani', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Joshi', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Rajinder', 'Initials': 'R', 'LastName': 'Parshad', 'Affiliation': 'Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}]",Surgical endoscopy,['10.1007/s00464-020-07980-z']
2473,32961255,"Tildrakizumab efficacy, drug survival, and safety are comparable in patients with psoriasis with and without metabolic syndrome: Long-term results from two phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2).","BACKGROUND


Data for the effect of metabolic syndrome (MetS) on efficacy and safety of biologic agents for psoriasis treatment are limited.
OBJECTIVE


To evaluate long-term tildrakizumab efficacy, drug survival, and safety in patients with psoriasis by baseline MetS status.
METHODS


Post hoc analyses of up to 3 years of efficacy data and 5 years of safety data from the phase 3, double-blind, randomized controlled reSURFACE 1 and 2 trial (NCT01722331; NCT01729754) base and extension studies were conducted for patients receiving continuous tildrakizumab 100 or 200 mg.
RESULTS


Of 338 (n = 124/214) and 307 (n = 147/160) patients continuously receiving tildrakizumab 100 and 200 mg, respectively, throughout the studies, 26/44 (21%/21%) and 34/30 (23%/19%) met MetS criteria. Proportions of Psoriasis Area and Severity Index (PASI) 75 responders in reSURFACE 1/2 were generally comparable in patients with vs without MetS at week 52 (tildrakizumab 100 mg, 85%/86% vs 86%/94%; tildrakizumab 200 mg, 76%/87% vs 76%/87%) and through week 148. Results were similar for PASI 90/100 responders. Tildrakizumab's safety profile did not vary by MetS status.
LIMITATIONS


Small sample size and post hoc analysis limit interpretation.
CONCLUSION


Long-term tildrakizumab efficacy and safety were comparable between patients with and without MetS.",2020,"Proportions of Psoriasis Area and Severity Index (PASI) 75 responders in reSURFACE 1/2 were generally comparable in patients with vs without MetS at week 52 (tildrakizumab 100 mg, 85%/86% vs 86%/94%; tildrakizumab 200 mg, 76%/87% vs 76%/87%) and through week 148.","['Of 338 (n = 124/214) and 307 (n = 147/160) patients continuously receiving', 'patients with and without MetS', 'patients with psoriasis by baseline MetS status', 'patients with psoriasis with and without metabolic syndrome']","['Tildrakizumab', 'tildrakizumab', 'continuous tildrakizumab 100 or 200 mg']","['Tildrakizumab efficacy, drug survival, and safety', 'Proportions of Psoriasis Area and Severity Index (PASI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.209411,"Proportions of Psoriasis Area and Severity Index (PASI) 75 responders in reSURFACE 1/2 were generally comparable in patients with vs without MetS at week 52 (tildrakizumab 100 mg, 85%/86% vs 86%/94%; tildrakizumab 200 mg, 76%/87% vs 76%/87%) and through week 148.","[{'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: lebwohl@aol.com.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology and Saint Louis University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Mendelsohn', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., Princeton, NJ.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Parno', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., Princeton, NJ.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Rozzo', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., Princeton, NJ.'}, {'ForeName': 'M Alan', 'Initials': 'MA', 'LastName': 'Menter', 'Affiliation': 'Division of Dermatology, Baylor Scott & White, and Texas A&M College of Medicine, Dallas, TX.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.09.047']
2474,32961273,High-Definition Transcranial Direct Current Stimulation Facilitates Emotional Face Processing in Individuals with High Autistic Traits: A Sham-Controlled Study.,"The deficit in emotional face processing is a critical impairment for individuals with high autistic traits. The temporalparietal junction(TPJ) is considered to be closely related to emotional face processing. The aim of this study was to examine the effect of highdefinition transcranial direct current stimulation (HD-tDCS) over the right temporal-parietal junction (rTPJ) on facial emotion processing of individuals with high autistic traits using eye-tracking technology. Twenty-nine participants with high autistic traits completed an eyetracking task (including happy, fearful and neutral faces) before and after five consecutive days of stimulation (anodal or sham). Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation. Moreover, this increased effect of mouth recognition with anodal rTPJ HD-tDCS was shown in both happy and fearful faces, but no remarkable difference was found in neutral faces. These findings suggest that right TPJ anodal HD-tDCS can facilitate emotional face processing in individuals with high autistic traits.",2020,"Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation.","['Twenty-nine participants with high autistic traits', 'individuals with high autistic traits', 'individuals with high autistic traits using eye-tracking technology', 'Individuals with High Autistic Traits']","['High-Definition Transcranial Direct Current Stimulation Facilitates Emotional Face Processing', 'TPJ anodal HD-tDCS', 'anodal HD-tDCS', 'highdefinition transcranial direct current stimulation (HD-tDCS', 'anodal rTPJ HD-tDCS', 'eyetracking task (including happy, fearful and neutral faces', 'right temporal-parietal junction (rTPJ']","['facial emotion processing', 'fixation time and fixation count', 'neutral faces']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",29.0,0.0460479,"Results showed that anodal HD-tDCS significantly increased fixation time and fixation count in the mouth area, but this effect was not found after the sham stimulation.","[{'ForeName': 'Yuxi', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Xuan', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Qianhui', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': 'Department of First Clinical Medical College, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of First Clinical Medical College, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Gongjun', 'Initials': 'G', 'LastName': 'Ji', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Fengqiong', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Department of Neurology, First Affiliated Hospital of Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China. Electronic address: wangkai1964@126.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Psychology, Chaohu Clinical Medical College, Anhui Medical University, Hefei 230032, China; Anhui Province Key Laboratory of Cognition and Neuropsychiatric Disorders, Hefei 230032, China; Collaborative Innovation Center for Neuropsychiatric Disorders and Mental Health, Anhui Medical University, Hefei 230032, China. Electronic address: zhanglei17236@aliyun.com.'}]",Neuroscience letters,['10.1016/j.neulet.2020.135396']
2475,32961347,Low-dose rituximab lowers serum Exosomal miR-150-5p in AChR-positive refractory myasthenia gravis patients.,"Two potentially related microRNAs (miRNAs; miR-150-5p and miR-146a-5p) were examined after low-dose rituximab (RTX) treatment in patients with acetylcholine receptor antibody (AChR)-positive refractory myasthenia gravis (MG). In this prospective, open-label, and self-controlled pilot trial, 12 AChR-positive refractory MG patients were administrated a single, low dose of RTX and followed up at six months. Results showed that RTX decreased the serum exosomal miR-150-5p, scores on three clinical indices (MGFA, MMT, ADL), and patients' prednisolone requirement. Additionally, CD19+ and CD27+ B cells decreased, showing a strong correlation with miR-150-5p. In conclusion, low-dose RTX is effective for AChR-positive refractory MG treatment. Furthermore, our data support the role of miR-150-5p as a potential biomarker for MG.",2020,"Additionally, CD19+ and CD27+ B cells decreased, showing a strong correlation with miR-150-5p.","['AChR-positive refractory myasthenia gravis patients', '12 AChR-positive refractory MG patients']","['Low-dose rituximab', 'RTX', 'acetylcholine receptor antibody ', 'rituximab (RTX']","['serum exosomal miR-150-5p, scores on three clinical indices (MGFA, MMT, ADL', 'CD19+ and CD27+ B cells']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0046370', 'cui_str': '2-methylcyclopentadienyl manganese tricarbonyl'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0054949', 'cui_str': 'Lymphocyte antigen CD27'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}]",12.0,0.0396666,"Additionally, CD19+ and CD27+ B cells decreased, showing a strong correlation with miR-150-5p.","[{'ForeName': 'Huahua', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China.'}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Jing', 'Affiliation': ""Department of Neurology, Jing'an District Centre Hospital of Shanghai, Fudan University, China.""}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China.'}, {'ForeName': 'Sushan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China. Electronic address: luosushan@fudan.edu.cn.'}, {'ForeName': 'Chongbo', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China; Department of Neurology, Jing'an District Centre Hospital of Shanghai, Fudan University, China. Electronic address: zhao_chongbo@fudan.edu.cn.""}]",Journal of neuroimmunology,['10.1016/j.jneuroim.2020.577383']
2476,32961360,COVID-19 hits a trial: Arguments against hastily deviating from the plan.,"The COVID-19 pandemic has substantially impacted the conduct of clinical trials. While initially preparing for a period of time, where it would likely be impossible to supervise trials in the usual way and precautionary measures had to be implemented to care for medication supply and general safety of study participants it is now important to consider, how the impact of the pandemic on trial outcome can be assessed, which measures are needed to decide, how to proceed with the trial and what is needed to compensate to irregularity introduced by the pandemic situation. Obviously not all trials will suffer to the same degree: some trials may be close to finalizing recruitment, others may not yet have started. Similarly not all clinical trials investigate vulnerable patient populations, but some will and may in addition have recruited to an extent that beneficial effects achieved in the initial phase of the trial may be outweighed by an increase e.g. in mortality that impacts both treatment groups. The situation is further complicated by the fact that the pandemic reached different countries in the world and even cities in one country at different points in time with different severity. Our example is a randomized and double-blind clinical trial comparing digitoxin and placebo in patients with advanced chronic heart failure. This trial has recruited roughly 1/3 of the overall 2400 patients when the disease outbreak reached Germany. We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post- COVID-19 periods of trial conduct regarding the question, whether the treatment effect can be considered consistent and with this generalizable. This is dependent on the size of the treatment effect and the impact of the pandemic. We argue, that in case of doubt, it may be wise to proceed with the original study plan.",2020,"We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post-","['patients with advanced chronic heart failure', '2400 patients when the disease outbreak reached Germany']",['digitoxin and placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0012258', 'cui_str': 'Digitoxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],2400.0,0.116561,"We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post-","[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Großhennig', 'Affiliation': 'Institut für Biometrie, Medizinische Hochschule Hannover, Germany. Electronic address: grosshennig.anika@mh-hannover.de.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institut für Biometrie, Medizinische Hochschule Hannover, Germany. Electronic address: koch.armin@mh-hannover.de.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106155']
2477,32961410,Intranasal oxytocin and the stress-buffering effects of social support during experimentally induced pain: The role of attachment security.,"BACKGROUND


This study examined whether intranasal oxytocin enhances the stress-buffering effects of social support during experimentally induced pain, taking into account the role of individual differences in attachment security.
METHODS


Female participants (N = 193) were randomly assigned to oxytocin (24 IU intranasal) or placebo and to receive support or no support from a friend (2 × 2 factorial design with repeated measures)). Participants underwent the Cold Pressor Task (CPT) and were monitored for heart rate variability (HRV: RMSSD) and heart rate and reported pain levels. The Experiences in Close Relationships Questionnaire was used to measure attachment.
RESULTS


Oxytocin reduced RMSSD (p = 0.003, partial ɳ 2  = 0.03) and increased heart rate (p = 0.039, partial ɳ 2  = 0.03) in individuals who received support, possibly reflecting an enhanced attentional state. Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
LIMITATIONS


Only female participants were examined. Future studies are needed to determine sex differences in how oxytocin shapes stress-buffering effects of support.
CONCLUSIONS


Oxytocin may enhance the salience of social proximity and may be a mechanism underlying previously reported social influences on cardiovascular and mental health. However, oxytocin effects depend on interpersonal insecurities and may trigger discomfort in avoidantly attached individuals. Caution about oxytocin's therapeutic promise is warranted.",2020,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","['Only female participants', 'Female participants (N\xa0=\xa0193']","['intranasal oxytocin', 'oxytocin', 'placebo and to receive support or no support from a friend', 'Oxytocin', 'Cold Pressor Task (CPT', 'Intranasal oxytocin']","['heart rate variability (HRV: RMSSD) and heart rate and reported pain levels', 'pain intensity', 'RMSSD', 'heart rate', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",193.0,0.159338,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2  = 0.06).
","[{'ForeName': 'M M E', 'Initials': 'MME', 'LastName': 'Riem', 'Affiliation': 'Behavioural Science Institute, Radboud University, The Netherlands; Department of Clinical Child and Family Studies, VU University, Amsterdam, The Netherlands. Electronic address: m.riem@psych.ru.nl.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Kunst', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Mentaal Beter, Breda, The Netherlands. Electronic address: L.E.Kunst@tilburguniversity.edu.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands. Electronic address: W.J.Kop@tilburguniversity.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.057']
2478,32961445,"Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study.","OBJECTIVES


In the phase III CASPIAN study, first-line durvalumab plus etoposide in combination with either cisplatin or carboplatin (EP) significantly improved overall survival (primary endpoint) versus EP alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) at the interim analysis. Here we report patient-reported outcomes (PROs).
MATERIALS AND METHODS


Treatment-naïve patients with ES-SCLC received 4 cycles of durvalumab plus EP every 3 weeks followed by maintenance durvalumab every 4 weeks until progression, or up to 6 cycles of EP every 3 weeks. PROs, assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13), were prespecified secondary endpoints. Changes from baseline to disease progression or 12 months in prespecified key disease-related symptoms (cough, dyspnea, chest pain, fatigue, appetite loss) were analyzed with a mixed model for repeated measures. Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL) from randomization was analyzed.
RESULTS


In the durvalumab plus EP and EP arms, 261 and 260 patients were PRO-evaluable. Patients in both arms experienced numerically reduced symptom burden over 12 months or until progression for key symptoms. For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009). Patients experienced longer TTD with durvalumab plus EP versus EP for all symptoms (hazard ratio [95% CI] for key symptoms: cough 0.78 [0.600‒1.026]; dyspnea 0.79 [0.625‒1.006]; chest pain 0.76 [0.575‒0.996]; fatigue 0.82 [0.653‒1.027]; appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL.
CONCLUSION


Addition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL compared with EP.",2020,"For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009).","['Treatment-naïve patients with ES-SCLC received 4 cycles of', 'patients with extensive-stage small-cell lung cancer (ES-SCLC', 'extensive-stage small-cell lung cancer (CASPIAN']","['first-line durvalumab plus platinum-etoposide versus platinum-etoposide', 'cisplatin or carboplatin (EP', 'EP alone', 'durvalumab plus EP']","['appetite loss 0.70 [0.542‒0.899]), functioning, and global health status/QoL.\nCONCLUSION\n\n\nAddition of durvalumab to first-line EP maintained QoL and delayed worsening of patient-reported symptoms, functioning, and global health status/QoL', 'Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13', 'Cancer (EORTC', 'appetite loss', 'chest pain 0.76', 'symptom burden', 'symptoms (cough, dyspnea, chest pain, fatigue, appetite loss', 'overall survival', 'Time to deterioration (TTD) of symptoms, functioning, and global health status/quality of life (QoL']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.142705,"For the improvements from baseline in appetite loss, the between-arm difference was statistically significant, favoring durvalumab plus EP (difference, -4.5; 99% CI: -9.04, -0.04; nominal p = 0.009).","[{'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Goldman', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: jwgoldman@mednet.ucla.edu.'}, {'ForeName': 'Marina Chiara', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Yuanbin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cancer & Hematology Centers of Western Michigan, Grand Rapids, MI, USA.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Dvorkin', 'Affiliation': 'BHI of Omsk Region Clinical Oncology Dispensary, Omsk, Russia.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Odessa National Medical University, Odessa, Ukraine.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Statsenko', 'Affiliation': 'Omsk Regional Cancer Center, Omsk, Russian Federation.'}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Ji', 'Affiliation': 'Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.'}, {'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Voitko', 'Affiliation': 'Kyiv City Clinical Oncological Centre, Kiev, Ukraine.'}, {'ForeName': 'Libor', 'Initials': 'L', 'LastName': 'Havel', 'Affiliation': 'Thomayer Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Artem', 'Initials': 'A', 'LastName': 'Poltoratskiy', 'Affiliation': 'Petrov Research Institute of Oncology, St Petersburg, Russian Federation.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Losonczy', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Lung Clinic, Munich-Gauting, Germany.'}, {'ForeName': 'Nikunj', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Laud', 'Affiliation': 'Statistical Services Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Shire', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.003']
2479,32961461,"Effectiveness of an integrated breastfeeding education program to improve self-efficacy and exclusive breastfeeding rate: A single-blind, randomised controlled study.","BACKGROUND


Low self-efficacy affects new mothers' ability to sustain breastfeeding. Interventions that increase self-efficacy could improve sustained breastfeeding.
OBJECTIVES


To develop an integrated breastfeeding education program based on self-efficacy theory, and evaluate the effect of the intervention on first-time mothers' breastfeeding self-efficacy and attitudes.
DESIGN


A single-blind, randomised controlled trial.
SETTING


A prenatal clinic of a teaching hospital.
PARTICIPANTS


First-time mothers with a singleton pregnancy (12-32 weeks' gestation) and their support partners were selected by convenience sampling (N = 104) and allocated by block-randomization to an intervention or control group.
METHODS


A 3-week breastfeeding intervention program was developed based on self-efficacy theory. The intervention group received the breastfeeding program; the control group received standard care. Data between groups were compared for scores on breastfeeding self-efficacy, infant feeding attitude, and breastfeeding practice, which were assessed using the Breastfeeding Self-Efficacy Scale-Short Form, the Iowa Infant Feeding Attitude Scale, and a structured questionnaire, respectively. Repeated data measurements were collected at baseline, 36-weeks' gestation, and postpartum at 1-week, and 1-, 3-, and 6-months.
RESULTS


Ninety-three mothers completed the study. Data were compared for the self-efficacy intervention group (n = 50) with the control group (n = 43). Baseline measures did not differ between groups. The intervention group had significantly higher breastfeeding self-efficacy at 36 weeks' gestation (mean difference (MD): 7.3, p < .001), and postpartum at 1-week (p < .001), 1-month (p < .001) and 3-months (p < .01) with MD: 6.7, 7.9, and 8.1, respectively; differences in scores from baseline were also significantly greater from 36 weeks' gestation to 3-months (MD from 9.1~9.9, p < .001) and 6-months postpartum (MD: 7.0, p < .05). Infant feeding attitude scores significantly improved from 36 weeks' gestation to 6-months postpartum for the intervention group (MD from 3.5~7.4, p < .05). Rates for exclusive and predominant breastfeeding postpartum were significantly higher for the intervention group vs control (p < .02) at 1-week (98% vs. 86%), 1-month (100% vs. 90.7%), and 3-months (94% vs. 76.7%). Odds ratio (OR) postpartum for exclusive and predominant breastfeeding was greater for the intervention group at 3-months (OR = 4.7, 95% Confidence interval (CI), 1.2 -18.6; p = .05) and for exclusive breastfeeding at 6-months (OR: 2.82, 95% CI 1.0-8.1; p = .05).
CONCLUSIONS


The breastfeeding education intervention improved breastfeeding self-efficacy, infant feeding attitudes, and exclusive breastfeeding rates. The breastfeeding education program could be effective for sustaining breastfeeding in new mothers.
TRIAL REGISTRATION


Registered with www.clinicaltrials.gov (NCT03807726).",2020,Rates for exclusive and predominant breastfeeding postpartum were significantly higher for the intervention group vs control (p < .02) at 1-week,"[""First-time mothers with a singleton pregnancy (12-32 weeks' gestation) and their support partners were selected by convenience sampling (N\xa0=\xa0104) and allocated by"", 'A prenatal clinic of a teaching hospital', 'Ninety-three mothers completed the study']","['breastfeeding program; the control group received standard care', 'integrated breastfeeding education program', 'block-randomization to an intervention or control group']","['breastfeeding self-efficacy, infant feeding attitude, and breastfeeding practice', 'Odds ratio (OR) postpartum for exclusive and predominant breastfeeding', 'Infant feeding attitude scores', 'Breastfeeding Self-Efficacy Scale-Short Form, the Iowa Infant Feeding Attitude Scale', 'Rates for exclusive and predominant breastfeeding postpartum', 'breastfeeding self-efficacy, infant feeding attitudes, and exclusive breastfeeding rates', 'self-efficacy', 'self-efficacy and exclusive breastfeeding rate', 'breastfeeding self-efficacy']","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418914', 'cui_str': 'Breastfeeding education'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",104.0,0.0829758,Rates for exclusive and predominant breastfeeding postpartum were significantly higher for the intervention group vs control (p < .02) at 1-week,"[{'ForeName': 'Juei-Fen', 'Initials': 'JF', 'LastName': 'Tseng', 'Affiliation': 'Department of Nursing, Tri-service General Hospital, Taipei, Taiwan; School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, 11031 Taipei, Taiwan.'}, {'ForeName': 'Su-Ru', 'Initials': 'SR', 'LastName': 'Chen', 'Affiliation': 'School of Nursing and Post-Baccalaureate Program in Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan. Electronic address: suru@tmu.edu.tw.'}, {'ForeName': 'Heng-Kien', 'Initials': 'HK', 'LastName': 'Au', 'Affiliation': 'Department of Obstetrics, Taipei Medical University Hospital, Taipei, Taiwan; Department of Obstetrics and Gynecology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; TMU Research Center for Cell Therapy and Regeneration Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Roselyn', 'Initials': 'R', 'LastName': 'Chipojola', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, 11031 Taipei, Taiwan; Kamuzu College of Nursing, Lilongwe, Malawi.'}, {'ForeName': 'Gabrielle T', 'Initials': 'GT', 'LastName': 'Lee', 'Affiliation': 'Applied Psychology, Faculty of Education, Western University, London, ON, Canada. Electronic address: glee329@uwo.ca.'}, {'ForeName': 'Pi-Hsia', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, 11031 Taipei, Taiwan. Electronic address: pihsia@tmu.edu.tw.'}, {'ForeName': 'Meei-Ling', 'Initials': 'ML', 'LastName': 'Shyu', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, 11031 Taipei, Taiwan. Electronic address: meeiling@tmu.edu.tw.'}, {'ForeName': 'Shu-Yu', 'Initials': 'SY', 'LastName': 'Kuo', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, 250 Wuxing Street, 11031 Taipei, Taiwan. Electronic address: sykuo@tmu.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103770']
2480,32961500,One-day Acceptance and Commitment Therapy workshop for preventing persistent post-surgical pain and dysfunction in at-risk veterans: A randomized controlled trial protocol.,"OBJECTIVE


Persistent post-surgical pain is common among patients undergoing surgery, is detrimental to patients' quality of life, and can precipitate long-term opioid use. The purpose of this randomized controlled trial is to assess the effects of a behavioral intervention offered prior to surgery for patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning.
METHODS


Described herein is an ongoing randomized, patient- and assessor-blind, attention-controlled multisite clinical trial. Four hundred and thirty Veterans indicated for total knee arthroplasty (TKA) with distress and/or pain will be recruited for this study. Participants will be randomly assigned to a one-day (~5 h) Acceptance and Commitment Therapy workshop or one-day education and attention control workshop. Approximately two weeks following their TKA surgery, patients receive an individualized booster session via phone. Following their TKA, patients complete assessments at 1 week, 6 weeks, 3 months, and 6 months.
RESULTS


The primary outcomes are pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills. Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT. This study is conducted mostly with older Veterans; therefore, results may not generalize to women and younger adults who are underrepresented in this veteran population.
CONCLUSIONS


The results of this study will provide the first evidence from a large-scale, patient- and assessor-blind controlled trial on the effectiveness of a brief behavioral intervention for the prevention of persistent post-surgical pain and dysfunction.",2020,Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT.,"['patients undergoing surgery', 'older Veterans', 'patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning', 'Four hundred and thirty Veterans', 'at-risk veterans', 'women and younger adults who are underrepresented in this veteran population']","['Acceptance and Commitment Therapy workshop or one-day education and attention control workshop', 'behavioral intervention']","['pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills', 'total knee arthroplasty (TKA) with distress and/or pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",430.0,0.299537,Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT.,"[{'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Roddy', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Derrecka M', 'Initials': 'DM', 'LastName': 'Boykin', 'Affiliation': 'South Central Mental Illness, Research and Clinical Center, Michael E. DeBakey VA Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hadlandsmyth', 'Affiliation': 'Department of Anesthesia, Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Marchman', 'Affiliation': 'Department of Psychology, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Green', 'Affiliation': 'Michael E. DeBakey Veteran Affairs Medical Center, Houston, TX, United States of America.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Buckwalter', 'Affiliation': 'Department of Orthopedics and Rehabilitation, Carver College of Medicine, University of Iowa, United States of America.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Garvin', 'Affiliation': 'Department of Psychiatry, University of Iowa Hospitals and Clinics, Iowa City, IA, United States of America.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Zimmerman', 'Affiliation': 'College of Public Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Jaewon', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Cortesi', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Merlyn', 'Initials': 'M', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Embree', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, IA, United States of America. Electronic address: barbara-rakel@uiowa.edu.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Dindo', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America; Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America. Electronic address: lilian.dindo@bcm.edu.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110250']
2481,32961507,The effects of acute work stress and appraisal on psychobiological stress responses in a group office environment.,"BACKGROUND


The high prevalence of office stress and its detrimental health consequences are of concern to individuals, employers and society at large. Laboratory studies investigating office stress have mostly relied on data from participants that were tested individually on abstract tasks. In this study, we examined the effect of psychosocial office stress and work interruptions on the psychobiological stress response in a realistic but controlled group office environment. We also explored the role of cognitive stress appraisal as an underlying mechanism mediating the relationship between work stressors and the stress response.
METHODS AND MATERIALS


Ninety participants (44 female; mean age 23.11 ± 3.80) were randomly assigned to either a control condition or one of two experimental conditions in which they were exposed to psychosocial stress with or without prior work interruptions in a realistic multi-participant laboratory setting. To induce psychosocial stress, we adapted the Trier Social Stress Test for Groups to an office environment. Throughout the experiment, we continuously monitored heart rate and heart rate variability. Participants repeatedly reported on their current mood, calmness, wakefulness and perceived stress and gave saliva samples to assess changes in salivary cortisol and salivary alpha-amylase. Additionally, cognitive appraisal of the psychosocial stress test was evaluated.
RESULTS


Our analyses revealed significant group differences for most outcomes during or immediately after the stress test (i.e., mood, calmness, perceived stress, salivary cortisol, heart rate, heart rate variability) and during recovery (i.e., salivary cortisol and heart rate). Interestingly, the condition that experienced work interruptions showed a higher increase of cortisol levels but appraised the stress test as less threatening than individuals that experienced only psychosocial stress. Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
DISCUSSION


The results showed that experimentally induced work stress led to significant responses of subjective measures of stress, the hypothalamic-pituitary-adrenal axis and the autonomic nervous system. However, there appears to be a discrepancy between the psychological and biological responses to preceding work interruptions. Appraising psychosocial stress as less threatening but still as challenging could be an adaptive way of coping and reflect a state of engagement and eustress.",2020,"Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
",['Ninety participants (44 female; mean age 23.11 ± 3.80'],['control condition or one of two experimental conditions in which they were exposed to psychosocial stress with or without prior work interruptions in a realistic multi-participant laboratory setting'],"['heart rate and heart rate variability', 'stress test (i.e., mood, calmness, perceived stress, salivary cortisol, heart rate, heart rate variability) and during recovery (i.e., salivary cortisol and heart rate', 'psychobiological stress responses', 'psychobiological stress response', 'subjective measures of stress, the hypothalamic-pituitary-adrenal axis and the autonomic nervous system', 'cortisol levels', 'current mood, calmness, wakefulness and perceived stress and gave saliva samples', 'salivary cortisol and salivary alpha-amylase']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}]",90.0,0.0154888,"Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
","[{'ForeName': 'Jasmine I', 'Initials': 'JI', 'LastName': 'Kerr', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland. Electronic address: jkerr@ethz.ch.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Naegelin', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Raphael P', 'Initials': 'RP', 'LastName': 'Weibel', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrario', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'La Marca', 'Affiliation': 'Chair of Clinical Psychology and Psychotherapy, Department of Psychology, University of Zurich, Binzmuehlestrasse 14, 8050 Zurich, Switzerland; Clinica Holistica Engiadina, Plaz 40, 7542 Susch, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'von Wangenheim', 'Affiliation': 'Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoelscher', 'Affiliation': 'Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland.'}, {'ForeName': 'Victor R', 'Initials': 'VR', 'LastName': 'Schinazi', 'Affiliation': 'Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland; Department of Psychology, Bond University, 14 University Drive, Robina Queensland 4226, Australia.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104837']
2482,32961514,The Effect of Intradermal Botulinum Toxin a injections on painful diabetic polyneuropathy.,"BACKGROUND AND AIMS


Botulinum toxin type A (BTX-A) have been recently administered to improve Diabetic neuropathies; however, the efficacy of this treatment for relieving pain in painful diabetic polyneuropathy (DPN) has not been studied yet. Herein, we investigated the efficacy of botulinum toxin A (BTX-A) on DPN.
METHODS


This prospective, randomized, double-blind, controlled trial was performed in Imam Hossein Medical Center, pain clinic (Tehran, Iran). Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs were randomly assigned to one of these three groups: 1. Group D1 received 150 units of BTX-A in one foot and normal saline 0.9% in the other foot, 2. Group D2 received BTX-A 150 units in both feet, 3. Group N received normal saline 0.9% in both feet. All injections were performed intradermally using insulin syringes in 20 different points of foot. Visual analogue scale (VAS) and neuropathy pain scale (NPS) were used to compare the groups.
RESULTS


The improvement of VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation was significant when comparing BTX-A and placebo groups. However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups. Furthermore, the percentage of changes after treatment indicated that sharp pain was improved more than other complaints (80%, 81%, and 37% for D1, D2, and N groups; respectively).
CONCLUSION


Intradermal administration of BTX-A was effective in improving VAS and all of the items of NPS in patients with diabetic polyneuropathy, except for dull and cold sensation.",2020,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","['painful diabetic polyneuropathy', 'patients with diabetic polyneuropathy', 'Imam Hossein Medical Center, pain clinic (Tehran, Iran', 'painful diabetic polyneuropathy (DPN', 'Diabetic patients (141 cases), between 40 and 70 years old with polyneuropathy in lower limbs']","['Intradermal Botulinum Toxin a injections', 'BTX-A in one foot and normal saline', 'botulinum toxin A (BTX-A', 'BTX', 'placebo', 'normal saline', 'BTX-A']","['dull and cold sensations improvement', 'sharp pain', 'VAS, pain intensity, sharp and hot sensation, sensitive and unpleasant sensation, deep and surface sensation', 'Visual analogue scale (VAS) and neuropathy pain scale (NPS']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0271680', 'cui_str': 'Diabetic polyneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0278144', 'cui_str': 'Dull pain'}, {'cui': 'C0234192', 'cui_str': 'Cold'}, {'cui': 'C0455270', 'cui_str': 'Sharp pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",,0.20487,"However, dull and cold sensations improvement (p = 0.114, and p = 0.653; respectively) did not show a significant difference between BTX-A injection and placebo groups.","[{'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Taheri', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meghdad', 'Initials': 'M', 'LastName': 'Sedaghat', 'Affiliation': 'Department of Internal Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Solhpour', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Rostami', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Safarpour Lima', 'Affiliation': 'Department of Neurology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: b.safarpour@sbmu.ac.ir.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.09.019']
2483,32961528,A Randomized Controlled Trial of Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis.,"OBJECTIVES


To test whether administration of prasugrel after coronary artery bypass grafting (CABG) reduces saphenous vein graft (SVG) thrombosis. Use of aspirin after CABG improves graft patency, but administration of other antiplatelet agents has yielded equivocal results.
METHODS


We performed a double-blind trial randomizing patients to prasugrel or placebo after CABG at four United States centers. Almost all patients were receiving aspirin. Follow-up angiography, optical coherence tomography (OCT), intravascular ultrasound (IVUS), and near-infrared spectroscopy (NIRS) were performed at 12 months. The primary efficacy endpoint was prevalence of OCT-detected SVG thrombus. The primary safety endpoint was incidence of Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding.
RESULTS


The study was stopped early due to slow enrollment after randomizing 84 patients. Mean age was 64 ± 6 years; 98% of the patients were men. Follow-up angiography was performed in 59 patients. IVUS was performed in 52 patients, OCT in 53 patients, and NIRS in 33 patients. Thrombus was identified by OCT in 56% vs 50% of patients in the prasugrel vs placebo groups, respectively (P=.78). Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19). The 1-year incidence of major adverse cardiovascular events was 14.3% vs 2.4% in the prasugrel and placebo groups, respectively (P=.20), without significant differences in GUSTO severe bleeding (P=.32).
CONCLUSION


Early SVG failure occurred in approximately one-third of patients. Prasugrel did not decrease prevalence of SVG thrombus 12 months after CABG.",2020,Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19).,"['after CABG at four United States centers', '59 patients', 'Mean age was 64 ± 6 years; 98% of the patients were men', 'Early Saphenous Vein Graft Thrombosis']","['prasugrel after coronary artery bypass grafting (CABG', 'IVUS', 'prasugrel or placebo', 'Follow-up angiography, optical coherence tomography (OCT), intravascular ultrasound (IVUS), and near-infrared spectroscopy (NIRS', 'placebo', 'Prasugrel', 'aspirin']","['Angiographic SVG failure', 'saphenous vein graft (SVG) thrombosis', '1-year incidence of major adverse cardiovascular events', 'GUSTO severe bleeding', 'graft patency', 'prevalence of OCT-detected SVG thrombus', 'Early SVG failure', 'incidence of Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0038418', 'cui_str': 'Streptokinase'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",59.0,0.37887,Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19).,"[{'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Danek', 'Affiliation': ''}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Karatasakis', 'Affiliation': ''}, {'ForeName': 'Kazeen', 'Initials': 'K', 'LastName': 'Abdullah', 'Affiliation': ''}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Iwnetu', 'Affiliation': ''}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Kalsaria', 'Affiliation': ''}, {'ForeName': 'Kendrick', 'Initials': 'K', 'LastName': 'Shunk', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zimmet', 'Affiliation': ''}, {'ForeName': 'Mladen', 'Initials': 'M', 'LastName': 'Vidovich', 'Affiliation': ''}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Bavry', 'Affiliation': ''}, {'ForeName': 'Bavana V', 'Initials': 'BV', 'LastName': 'Rangan', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Roesle', 'Affiliation': ''}, {'ForeName': 'Decebal', 'Initials': 'D', 'LastName': 'Griza', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Stanley', 'Affiliation': ''}, {'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': ''}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': ''}, {'ForeName': 'Emmanouil S', 'Initials': 'ES', 'LastName': 'Brilakis', 'Affiliation': ''}, {'ForeName': 'Shuaib M', 'Initials': 'SM', 'LastName': 'Abdullah', 'Affiliation': 'Shuaib Abdullah, MD, Veterans Affairs North Texas Health Care System, 4500 South Lancaster, 111A, Dallas, TX 75216 USA. shuaib.abdullah@utsouthwestern.edu.'}]",The Journal of invasive cardiology,[]
2484,32961529,Randomized COmparison of Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Radial Artery Patency: The OPEN-Radial Trial.,"BACKGROUND


Radial artery occlusion (RAO) occurs after transradial access (TRA), limiting future ipsilateral access. Pragmatic RAO-lowering strategies need to be developed.
METHODS


Patients undergoing transradial cardiac catheterization were randomized to receive postprocedural hemostasis with either a single-bladder radial compression band (group 1) or a double-balloon band capable of simultaneous ipsilateral ulnar artery compression (group 2). Hemostatic compression was performed for 120 minutes. Patients in group 2 received ipsilateral ulnar artery compression for the first 60 minutes of radial hemostasis. The primary endpoint of the study was achievement of patent hemostasis, defined as radial artery patency at 15 minutes after onset of hemostatic compression. Radial artery patency was measured at 15 minutes, 60 minutes, 90 minutes, and 120 minutes after onset of compression and 1 hour after removal of the compression bands.
RESULTS


A total of 253 patients were randomized (127 in group 1 and 126 in group 2). Patent hemostasis was achieved significantly more frequently in group 2 vs group 1 (96.8% vs 74.8%, respectively; P<.001). RAO at 1 hour post band removal was significantly lower in group 2 vs group 1 (1.6% vs 10.2%, respectively; P<.001). Rebound bleeding occurred less frequently in group 2 vs group 1 (1.6% vs 7.9%, respectively; P=.03).
CONCLUSION


Ipsilateral ulnar compression performed for the initial 1 hour during the radial hemostatic process after TRA using a dedicated double-balloon device is associated with higher rates of patent hemostasis and lower incidence of RAO compared with a single-balloon band.",2020,"Patent hemostasis was achieved significantly more frequently in group 2 vs group 1 (96.8% vs 74.8%, respectively; P<.001).","['Patients undergoing transradial cardiac catheterization', '253 patients']","['ipsilateral ulnar artery compression', 'postprocedural hemostasis with either a single-bladder radial compression band (group 1) or a double-balloon band capable of simultaneous ipsilateral ulnar artery compression', 'Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression']","['Radial artery patency', 'Patent hemostasis', 'Rebound bleeding', 'achievement of patent hemostasis, defined as radial artery patency', 'Hemostatic compression', 'RAO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0162858', 'cui_str': 'Structure of ulnar artery'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",253.0,0.215156,"Patent hemostasis was achieved significantly more frequently in group 2 vs group 1 (96.8% vs 74.8%, respectively; P<.001).","[{'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Bhavin A', 'Initials': 'BA', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Tejas M', 'Initials': 'TM', 'LastName': 'Patel', 'Affiliation': 'Apex Heart Institute, Ahmedabad, India. tejaspatel@apexheart.in.'}]",The Journal of invasive cardiology,[]
2485,32961569,The Role of Coconut Oil in Treating Patients Affected by Plaque-Induced Gingivitis: A Pilot Study.,"OBJECTIVES


The aim of the study was to evaluate the coconut oil pulling efficacy as adjuvant in reducing plaque formation and in treating plaque-induced gingivitis.
MATERIALS AND METHODS


A sample of 20 patients was divided into two groups: a study and a control group. In the study group, coconut oil, in form of mouthwash, was administered to a sample of patients affected by gingivitis, aged between 18 and 35. The protocol established a daily application of the product for 30 days, where clinical parameters for plaque formation and gingivitis-plaque index (PI), bleeding index (BI)-will be evaluated during the recalls on a specific periodontal chart. The control group did not associate a coadjuvant to the normal daily oral health procedures and the same clinical parameters were evaluated at t0 and after 30 days (t1). The data were statistically analyzed using Student's  t -test, establishing the significance level as  p  < 0.05.
RESULTS


PI and BI decreased in both groups, with a more relevant and significant drop in the study group, from a mean value of PI of 58.0 to 19.3 and a mean value of BI of 33.5 to 5.0. In the control group, the values decreased, respectively, from 53.9 to 29.1 for PI, and from 33.5 to 16.2. Furthermore, no significant side effect was reported during coconut oil pulling therapy.
CONCLUSIONS


The collected data showed significant and promising improvements in reducing plaque formation and gingivitis. However, further researches have to be performed to have more consistent and statistically significant data on larger samples and to fully understand the mechanisms of action and effectiveness.",2020,The control group did not associate a coadjuvant to the normal daily oral health procedures and the same clinical parameters were evaluated at t0 and after 30 days (t1).,"['20 patients', 'patients affected by gingivitis, aged between 18 and 35', 'Treating Patients Affected by Plaque-Induced Gingivitis']","['coconut oil', 'Coconut Oil']","['PI and BI', 'plaque formation', 'plaque formation and gingivitis-plaque index (PI), bleeding index', 'plaque formation and gingivitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0056060', 'cui_str': 'Coconut Oil'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",20.0,0.0257104,The control group did not associate a coadjuvant to the normal daily oral health procedures and the same clinical parameters were evaluated at t0 and after 30 days (t1).,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ripari', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Filippone', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Zumbo', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Covello', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Zara', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Iole', 'Initials': 'I', 'LastName': 'Vozza', 'Affiliation': 'Department of Oral and Maxillo-facial Sciences, Sapienza University of Rome, Rome, Italy.'}]",European journal of dentistry,['10.1055/s-0040-1714194']
2486,32961589,Recovery after enhanced versus conventional care laparoscopic hysterectomy performed in the afternoon: A randomized controlled trial.,"OBJECTIVE


To compare enhanced recovery after surgery (ERAS) and conventional care (CC) protocols on outcomes of laparoscopic hysterectomy (LH) performed in the afternoon.
METHODS


A single-center randomized controlled trial was conducted on 120 women undergoing LH who were randomly divided into the intervention group (IG; n=60) and control group (CG; n=60). Women in the IG were treated according to the ERAS protocol and those in the CG according to the CC protocol. The primary outcome was the length of hospitalization. Secondary outcomes were postoperative opioid use, postoperative pain and emesis, complications, operative bleeding, and time.
RESULTS


More women discharged during 24 hours in the IG than in the CG (88% vs 55%, P<0.001). The time to actual discharge (19 vs 22 hours, P<0.001) and ready-to-discharge time (15 vs 21 hours, P<0.001) were shorter and the use of oxycodone was lower (0 mg [0-0 vs 2.5 mg [0-10], P<0.001) in the IG than in the CG, respectively. Otherwise, no other significant differences between the groups were observed. The follow-up time was one month.
CONCLUSION


The ERAS protocol reduces hospital stay and decreases the use of opioids with no impairment in surgical outcome of LH. ClinicalTrials.gov: NCT03828981.",2020,"More women discharged during 24 hours in the IG than in the CG (88% vs 55%, P<0.001).",['120 women undergoing LH'],"['laparoscopic hysterectomy (LH', 'afternoon', 'surgery (ERAS) and conventional care (CC) protocols', 'conventional care laparoscopic hysterectomy', 'oxycodone']","['hospital stay', 'time to actual discharge', 'length of hospitalization', 'postoperative opioid use, postoperative pain and emesis, complications, operative bleeding, and time', 'ready-to-discharge time']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3267156', 'cui_str': 'Operative bleeding'}]",120.0,0.0997711,"More women discharged during 24 hours in the IG than in the CG (88% vs 55%, P<0.001).","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kilpiö', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Päivi S M', 'Initials': 'PSM', 'LastName': 'Härkki', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Maarit J', 'Initials': 'MJ', 'LastName': 'Mentula', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Väänänen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Päivi I', 'Initials': 'PI', 'LastName': 'Pakarinen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13382']
2487,32961617,"Irbesartan treatment does not influence plasma levels of the dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone in participants with type 2 diabetes and microalbuminuria: an IRMA2 sub-study.","AIM


Angiotensin receptor blockers (ARBs) reduce vascular complications in diabetes independently of blood pressure. Experimental studies suggested that ARBs may restore the detoxifying enzyme glyoxalase 1, thereby lowering dicarbonyls such as methylglyoxal. Human data on the effects of ARBs on plasma dicarbonyl levels are lacking. We investigated, in individuals with type 2 diabetes, whether irbesartan lowered plasma levels of the dicarbonyls methylglyoxal, glyoxal, 3-deoxyglucosone and their derived advanced glycation end products (AGEs), and increased d-lactate, reflecting greater methylglyoxal flux.
METHODS


We analysed a subset of the Irbesartan in Patients with T2D and Microalbuminuria (IRMA2) study. We measured plasma dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone, free AGEs and d-lactate using ultra-performance liquid chromatography tandem mass-spectrometry (UPLC-MS/MS) in the treatment arm receiving 300 mg irbesartan (n = 121) and a placebo group (n = 101) at baseline and after 1 and 2 years. Effect of treatment was analysed with repeated measurements ANOVA.
RESULTS


There was a slight, but significant difference in baseline median methylglyoxal levels [placebo 1119 (907-1509) nmol/l vs. irbesartan 300 mg 1053 (820-1427) nmol/l], but no significant changes were observed in any of the plasma dicarbonyls over time in either group and there was no effect of irbesartan treatment on plasma free AGEs or d-lactate levels at either 1 or 2 years.
CONCLUSION


Irbesartan treatment does not change plasma levels of the dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone, free AGEs or d-lactate in type 2 diabetes. This indicates that increased dicarbonyls in type 2 diabetes are not targetable by ARBs, and other approaches to lower systemic dicarbonyls are needed in type 2 diabetes. (Clinical Trial Registry No: #NCT00317915).",2020,"CONCLUSION


Irbesartan treatment does not change plasma levels of the dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone, free AGEs or d-lactate in type 2 diabetes.","['participants with type 2 diabetes and microalbuminuria', 'individuals with type 2 diabetes, whether irbesartan lowered plasma levels of the dicarbonyls methylglyoxal, glyoxal, 3-deoxyglucosone and their derived advanced glycation end products (AGEs), and increased d-lactate, reflecting greater methylglyoxal flux', 'Patients with T2D and Microalbuminuria (IRMA2) study']","['placebo', 'ARBs', 'Angiotensin receptor blockers (ARBs']","['baseline median methylglyoxal levels', 'plasma dicarbonyls', 'plasma dicarbonyl levels', 'plasma dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone, free AGEs and d-lactate using ultra-performance liquid chromatography tandem mass-spectrometry (UPLC-MS/MS', 'plasma free AGEs or d-lactate levels']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034338', 'cui_str': 'Pyruvaldehyde'}, {'cui': 'C0017992', 'cui_str': 'Glyoxal'}, {'cui': 'C0047359', 'cui_str': '3-deoxyglucosone'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0522080', 'cui_str': 'D-lactate'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0034338', 'cui_str': 'Pyruvaldehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017992', 'cui_str': 'Glyoxal'}, {'cui': 'C0047359', 'cui_str': '3-deoxyglucosone'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C0522080', 'cui_str': 'D-lactate'}, {'cui': 'C0008565', 'cui_str': 'Liquid chromatography measurement'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}]",,0.0999158,"CONCLUSION


Irbesartan treatment does not change plasma levels of the dicarbonyls methylglyoxal, glyoxal and 3-deoxyglucosone, free AGEs or d-lactate in type 2 diabetes.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piazza', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre.'}, {'ForeName': 'N M J', 'Initials': 'NMJ', 'LastName': 'Hanssen', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Scheijen', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre.'}, {'ForeName': 'M P H', 'Initials': 'MPH', 'LastName': 'van de Waarenburg', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre.'}, {'ForeName': 'M M J', 'Initials': 'MMJ', 'LastName': 'van Greevenbroek', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hovind', 'Affiliation': 'Steno Diabetes Center Copenhagen.'}, {'ForeName': 'C D A', 'Initials': 'CDA', 'LastName': 'Stehouwer', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre.'}, {'ForeName': 'H-H', 'Initials': 'HH', 'LastName': 'Parving', 'Affiliation': 'Medical Endocrinology, University Hospital of Copenhagen.'}, {'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Schalkwijk', 'Affiliation': 'Internal Medicine, Maastricht University Medical Centre.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14405']
2488,32961681,The Influence of Hippotherapy on the Body Posture in a Sitting Position among Children with Cerebral Palsy.,"The purpose of this study was to assess the influence of hippotherapy (therapy with horses) on posture and body function among children with cerebral palsy. A case-control study included forty-five children aged 6-12 years, classified as Gross Motor Function Classification System (GMFCS) level I or II, with spastic diplegia or hemiplegia. The participants were randomly divided into three groups: study I (n = 15), study II (n = 15) and control (n = 15). The children from the study groups attended 30min hippotherapy sessions for 12 consecutive weeks, twice (study group I) or once (study group II) a week. The Sitting Assessment Scale (SAS) was used. A comparison of SAS showed an improvement in almost all the assessed categories among the children who participated in hippotherapy. In study group I, statistically significant differences were noted in the assessment of head position control, arm function (in both cases,  p  = 0.012) and trunk control ( p  = 0.005) and in study group II in the assessment of trunk control ( p  = 0.028). Hippotherapy has a positive influence on the body posture and function of individual body parts in a sitting position among children with cerebral palsy.",2020,"In study group I, statistically significant differences were noted in the assessment of head position control, arm function (in both cases,  p  = 0.012) and trunk control ( p  = 0.005) and in study group II in the assessment of trunk control ( p  = 0.028).","['children who participated in hippotherapy', 'forty-five children aged 6-12 years, classified as Gross Motor Function Classification System ', 'children with cerebral palsy', 'Children with Cerebral Palsy']","['Hippotherapy', 'hippotherapy (therapy with horses', 'SAS']","['trunk control', 'Sitting Assessment Scale (SAS', 'posture and body function', 'head position control, arm function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0582540', 'cui_str': 'Head position finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",45.0,0.0101334,"In study group I, statistically significant differences were noted in the assessment of head position control, arm function (in both cases,  p  = 0.012) and trunk control ( p  = 0.005) and in study group II in the assessment of trunk control ( p  = 0.028).","[{'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Matusiak-Wieczorek', 'Affiliation': 'Sports Medicine Institute, Social and Preventive Medicine Department, Medical University of Lodz, 92-213 Lodz, Poland.'}, {'ForeName': 'Elzbieta', 'Initials': 'E', 'LastName': 'Dziankowska-Zaborszczyk', 'Affiliation': 'Epidemiology and Biostatistics Institute, Social and Preventive Medicine Department, Medical University of Lodz, 90-752 Lodz, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Synder', 'Affiliation': 'Orthopedics Department, Medical University of Lodz, 92-213 Lodz, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Borowski', 'Affiliation': 'Orthopedics Department, Medical University of Lodz, 92-213 Lodz, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17186846']
2489,32961793,Conventional and Virtual Reality Mirror Therapies in Upper Obstetric Brachial Palsy: A Randomized Pilot Study.,"The abilities of children diagnosed with Obstetric Brachial Palsy (OBP) are limited by brachial plexus injuries. Thus, their participation in the community is hindered, which involves a lower quality of life due to worse performance in activities of daily living as a consequence of the functional limitations of the affected upper limb. Conventional Mirror Therapy (Conventional MT) and Virtual Therapy improve the affected upper limb functionality. Therefore, the aim of this study was to compare the effects of Conventional MT and Virtual Reality MT on the spontaneous use of the affected upper limb and quality of life of children with upper Obstetric Brachial Palsy between 6 and 12 years of age. A randomized pilot study was performed. Twelve children were randomly assigned to perform Conventional Mirror Therapy or Virtual Reality Mirror Therapy for four weeks. Ten children completed the treatment. Two assessments (pre/post-intervention) were carried out to assess the spontaneous use of the affected upper limb and the quality of life using the Children's Hand-use Experience Questionnaire (CHEQ) and the Pediatric Quality of Life Inventory Generic Core Scales (PedsQL TM 4.0), respectively. There was a statistically significant increment in spontaneous use, observed in independent tasks ( p  = 0.02) and in the use of the affected hand with grasp ( p  = 0.04), measured with the CHEQ, for the Virtual Reality MT group. There were no statistically significant changes ( p  > 0.05) for the Conventional MT group in the spontaneous use of the affected upper limb. Regarding the quality of life, statistically significant changes were obtained in the Physical and Health activity categories of the parents' questionnaire ( p  = 0.03) and in the total score of the children's questionnaire ( p  = 0.04) in the Virtual Reality MT group, measured using the PedsQL TM 4.0. Statistically significant changes were not obtained for the quality of life in the Conventional MT group. This study suggests that, compared to Conventional MT, Virtual Reality MT would be a home-based therapeutic complement to increase independent bimanual tasks using grasp in the affected upper limb and improve the quality of life of children diagnosed with upper OBP in the age range of 6-12 years.",2020,"Regarding the quality of life, statistically significant changes were obtained in the Physical and Health activity categories of the parents' questionnaire ( p  = 0.03) and in the total score of the children's questionnaire ( p  = 0.04) in the Virtual Reality MT group, measured using the PedsQL TM 4.0.","['children diagnosed with Obstetric Brachial Palsy (OBP', 'Upper Obstetric Brachial Palsy', 'children diagnosed with upper OBP in the age range of 6-12 years', 'children with upper Obstetric Brachial Palsy between 6 and 12 years of age', 'Twelve children']","['Conventional MT and Virtual Reality MT', 'Conventional and Virtual Reality Mirror Therapies', 'Conventional Mirror Therapy (Conventional MT) and Virtual Therapy', 'Conventional Mirror Therapy or Virtual Reality Mirror Therapy']","['Physical and Health activity categories', ""quality of life using the Children's Hand-use Experience Questionnaire (CHEQ) and the Pediatric Quality of Life Inventory Generic Core Scales"", 'quality of life', 'spontaneous use']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]",12.0,0.0449876,"Regarding the quality of life, statistically significant changes were obtained in the Physical and Health activity categories of the parents' questionnaire ( p  = 0.03) and in the total score of the children's questionnaire ( p  = 0.04) in the Virtual Reality MT group, measured using the PedsQL TM 4.0.","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Yeves-Lite', 'Affiliation': 'San-José Institute Foundation, Avda. de la Hospitalidad, s/n, 28054 Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Zuil-Escobar', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, CEU-San Pablo University, Urb. Montepríncipe, s/n., 28668 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Martínez-Cepa', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, CEU-San Pablo University, Urb. Montepríncipe, s/n., 28668 Madrid, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Romay-Barrero', 'Affiliation': 'Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Asunción', 'Initials': 'A', 'LastName': 'Ferri-Morales', 'Affiliation': 'Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Palomo-Carrión', 'Affiliation': 'Department of Nursing, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, Spain.'}]",Journal of clinical medicine,['10.3390/jcm9093021']
2490,32961806,Feasibility of Ultra-Low-Dose CT for Bronchoscopy of Peripheral Lung Lesions.,"Background and objectives : Thin-section computed tomography (CT) is essential for identifying small bronchi during bronchoscopy using radial endobronchial ultrasound. Some patients should receive an additional CT for a thin-section image. We performed a retrospective study with a prospectively collected database to identify the optimal radiation dose for thin-section CT during peripheral bronchoscopy.  Materials and Methods : In total, 91 patients with peripheral lung lesions underwent thin-section CT (both standard CT as a reference and ultra-low-dose CT (ultra-LDCT)). The patients were randomly assigned to one of four groups according to the ultra-LDCT parameters: group 1 = 120 kVp, 25 mAs; group 2 = 100 kVp, 15 mAs; group 3 = 120 kVp, 5 mAs; and group 4 = 100 kVp, 5 mAs. Two radiologists and two physicians analyzed both the standard CT and ultra-LDCT.  Results : The effective doses (EDs) of ultra-LDCT significantly differed among the four groups (median EDs were 0.88, 0.34, 0.19, and 0.12 mSv for groups 1-4, respectively;  p  < 0.001). Median differences in peripheral airway wall thickness were higher in group 4 than in other groups (differences in median wall thickness measured by two radiologists were 0.4-0.5 mm and 0.8-0.9 mm for groups 1-3 and group 4, respectively). Bronchus signs on ultra-LDCT in groups 1 and 2 were well correlated with those of the standard-dose CT (accuracies of two radiologists and two pulmonary physicians were 95-100%).  Conclusions : Our results indicate that ultra-LDCT with ED of >0.34 mSv (ED of group 2) is feasible for peripheral bronchoscopy.",2020,"Median differences in peripheral airway wall thickness were higher in group 4 than in other groups (differences in median wall thickness measured by two radiologists were 0.4-0.5 mm and 0.8-0.9 mm for groups 1-3 and group 4, respectively).","['91 patients with peripheral lung lesions underwent', 'Bronchoscopy of Peripheral Lung Lesions']","['ultra-LDCT', 'thin-section CT', 'Ultra-Low-Dose CT', 'Thin-section computed tomography (CT', 'Materials and Methods ']","['peripheral airway wall thickness', 'median wall thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}]","[{'cui': 'C4075962', 'cui_str': 'Low dose computed tomography of thorax'}, {'cui': 'C0026040', 'cui_str': 'Thin Sectioning'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",91.0,0.0308828,"Median differences in peripheral airway wall thickness were higher in group 4 than in other groups (differences in median wall thickness measured by two radiologists were 0.4-0.5 mm and 0.8-0.9 mm for groups 1-3 and group 4, respectively).","[{'ForeName': 'Jung Seop', 'Initials': 'JS', 'LastName': 'Eom', 'Affiliation': 'Department of Internal Medicine, Pusan National University School of Medicine, Busan 43241, Korea.'}, {'ForeName': 'Geewon', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': 'Biomedical Research Institute, Pusan National University Hospital, Busan 43241, Korea.'}, {'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Roh', 'Affiliation': 'Department of Internal Medicine, Pusan National University School of Medicine, Busan 43241, Korea.'}, {'ForeName': 'Hyun Sung', 'Initials': 'HS', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Pusan National University School of Medicine, Busan 43241, Korea.'}, {'ForeName': 'Yeon Joo', 'Initials': 'YJ', 'LastName': 'Jeong', 'Affiliation': 'Biomedical Research Institute, Pusan National University Hospital, Busan 43241, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56090479']
2491,32961834,Effect of Electronic Activity Monitors and Pedometers on Health: Results from the TAME Health Pilot Randomized Pragmatic Trial.,"Background:  Brief counseling and self-monitoring with a pedometer are common practice within primary care for physical activity promotion. It is unknown how high-tech electronic activity monitors compare to pedometers within this setting. This study aimed to investigate the outcomes, through effect size estimation, of an electronic activity monitor-based intervention to increase physical activity and decrease cardiovascular disease risk.  Method:  The pilot randomized controlled trial was pre-registered online at clinicaltrials.gov (NCT02554435). Forty overweight, sedentary participants 55-74 years of age were randomized to wear a pedometer or an electronic activity monitor for 12 weeks. Physical activity was measured objectively for 7 days at baseline and follow-up by a SenseWear monitor and cardiovascular disease risk was estimated by the Framingham risk calculator.  Results:  Effect sizes for behavioral and health outcomes ranged from small to medium. While these effect sizes were favorable to the intervention group for physical activity (PA) (d = 0.78) and general health (d = 0.39), they were not favorable for measures.  Conclusion:  The results of this pilot trial show promise for this low-intensity intervention strategy, but large-scale trials are needed to test its efficacy.",2020,"While these effect sizes were favorable to the intervention group for physical activity (PA) (d = 0.78) and general health (d = 0.39), they were not favorable for measures.  ","['Forty overweight, sedentary participants 55-74 years of age']","['electronic activity monitor-based intervention', 'Electronic Activity Monitors and Pedometers', 'electronic activity monitor']","['physical activity (PA', 'Physical activity', 'general health', 'Health']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",40.0,0.0880024,"While these effect sizes were favorable to the intervention group for physical activity (PA) (d = 0.78) and general health (d = 0.39), they were not favorable for measures.  ","[{'ForeName': 'Zakkoyya H', 'Initials': 'ZH', 'LastName': 'Lewis', 'Affiliation': 'College of Science, Department of Kinesiology and Health Promotion, California State Polytechnic University Pomona, 3801 West Temple Ave., Pomona, CA 91768, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Ottenbacher', 'Affiliation': 'School of Health Professions, Division of Rehabilitation Sciences, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}, {'ForeName': 'Steve R', 'Initials': 'SR', 'LastName': 'Fisher', 'Affiliation': 'School of Health Professions, Department of Physical Therapy, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}, {'ForeName': 'Kristofer', 'Initials': 'K', 'LastName': 'Jennings', 'Affiliation': 'Department of Biostatistics, MD Anderson Cancer Center, 1400 Pressler St., Unit 1411, Houston, TX 77030-4008, USA.'}, {'ForeName': 'Arleen F', 'Initials': 'AF', 'LastName': 'Brown', 'Affiliation': 'School of Medicine, Division of General Internal Medicine and Health Services Research, University of California Los Angeles, 1100 Glendon, Ave., Los Angeles, CA 90095, USA.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Swartz', 'Affiliation': 'Department of Pediatrics, Division of Pediatrics, MD Anderson Cancer Center, 7777 Knight Rd., Houston, TX 77054, USA.'}, {'ForeName': 'Eloisa', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Sealy Center on Aging, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Lyons', 'Affiliation': 'School of Health Professions, Department of Nutrition and Metabolism, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17186800']
2492,32961848,Body Image Relates to Exercise-Induced Antinociception and Mood Changes in Young Adults: A Randomized Longitudinal Exercise Intervention.,"Background:  An important motivation for adolescents and young adults to engage in aerobic exercise (AE) is to improve fitness, body composition and physical appearance. These parameters have an impact on bodily perception as conceptualized by the 'body image' (BI) construct. AE is known to have positive effects on pain perception, mood, and body image (BI). However, no study has hitherto investigated their interrelationship within one study.  Methods:  Participants were randomly assigned to an intervention group (IG,  n  = 16, 6 months of AE) or a passive control group (CG,  n  = 10). Frankfurt Body-Concept Scales (FKKS), Positive and Negative Affect Scale (PANAS), State and Trait Anxiety Inventory, warmth and heat pain thresholds (WPT, HPT), pain tolerance, and graded exercise test data from baseline (T0) and the end of the intervention (T6) were analyzed using a paired  t -test ( p  < 0.05).  Results:  A significant increase in the BI dimension 'physical efficacy' was identified from T0 to T6, which correlated positively with PANAS Positive Affect Scale and HPT.  Conclusion:  Data in young adults undergoing AE indicate that changes in the BI sub-category 'physical efficacy' are closely linked with changes in positive affect and antinociception. These novel findings suggest that BI plays a role in antinociception and positive affect.",2020,"A significant increase in the BI dimension 'physical efficacy' was identified from T0 to T6, which correlated positively with PANAS Positive Affect Scale and HPT.  ","['Young Adults', 'adolescents and young adults', 'young adults undergoing AE']","['aerobic exercise (AE', 'intervention group (IG,  n  = 16, 6 months of AE) or a passive control']","['Frankfurt Body-Concept Scales (FKKS), Positive and Negative Affect Scale (PANAS), State and Trait Anxiety Inventory, warmth and heat pain thresholds (WPT, HPT), pain tolerance, and graded exercise test data', ""BI dimension 'physical efficacy"", 'pain perception, mood, and body image (BI']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",,0.0351208,"A significant increase in the BI dimension 'physical efficacy' was identified from T0 to T6, which correlated positively with PANAS Positive Affect Scale and HPT.  ","[{'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Maurer', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Deckert', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Levenig', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, 44780 Bochum, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Schörkmaier', 'Affiliation': 'German Center for Neurodegenerative Diseases, 53105 Bonn, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Stangier', 'Affiliation': 'German Center for Neurodegenerative Diseases, 53105 Bonn, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Attenberger', 'Affiliation': 'Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Hasenbring', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, 44780 Bochum, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Boecker', 'Affiliation': 'Functional Neuroimaging Group, Clinic for Diagnostic and Interventional Radiology, University Hospital Bonn, 53127 Bonn, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17186801']
2493,32959589,[Effect of acupoint application therapy at different timing points on gastrointestinal function recovery and heart rate variability after laparoscopic resection of colorectal cancer].,"OBJECTIVE


To observe the effect of acupoint application therapy at different timing points on the gastrointestinal function recovery and heart rate variability (HRV) after laparoscopic resection of colorectal cancer under the instruction of enhanced recovery after surgery (ERAS).
METHODS


A total of 105 patients for the selective laparoscopic resection of colorectal cancer were selected and randomized into a preoperative acupoint application group (35 cases, 3 cases dropped off), a postoperative acupoint application group (35 cases, 1 case dropped out) and a control group (35 cases, 2 cases dropped off). In the control group, ERAS interventions were provided, such as health education, fluid supplementation and multi-mode analgesia. On the base of the treatment as the control group, in the preoperative acupoint application group and the postoperative acupoint application group, 3 days before operation and 6 h after operation, the acupoint application therapy was given respectively. The acupoints were Zusanli (ST 36), Shangjuxu (ST 37), Sanyinjiao (SP 6), Neiguan (PC 6) and Xiajuxu (ST 39). The acupoint application was exerted for 6 h each time, once daily till the first postoperative exhaust and defecation presented. It was to observe the time of the first postoperative exhaust, defecation and food intake, the score of visual analogue scale (VAS) 1 to 3 days after operation, the total score of gastrointestinal symptom rating scale (GSRS) before and 1 week after operation, as well as the related indicators of HRV [standard deviation of NN intervals (SDNN) and the ratio of low-frequency power and high frequency power (LF/HF)] in the three groups successively. Besides, the adverse reactions were recorded during intervention in the three groups.
RESULTS


Compared with the control group, the time of the first postoperative exhaust and the time of the first postoperative defecation were all earlier in the preoperative acupoint application group and the postoperative acupoint application group respectively ( P <0.05), and VAS scores 1 to 3 days after operation and total GSRS scores 1 week after operation were all reduced ( P <0.05); the time of first food intake was earlier after operation ( P <0.05), and SDNN and LF/LF were increased 1 day and 3 days after operation in the preoperative acupoint application group ( P <0.05). Compared with the postoperative acupoint application group, in the preoperative acupoint application group, the time of the first postoperative exhaust and the time of the first postoperative defecation were all earlier ( P <0.05), VAS scores were reduced in 1 to 3 days after operation ( P <0.05), and SDNN 1 day and 3 days after operation and LF/HF 1 day after operation were all increased ( P <0.05). No adverse reaction was detected in patients of the three groups.
CONCLUSION


Under the instruction of ERAS, the preoperative acupoint application effectively promotes the postoperative gastrointestinal function recovery, improves HRV and autonomous nerve function in the patients after laparoscopic resection of colorectal cancer. The therapeutic effect of this therapy is better than the postoperative acupoint application.",2020,"No adverse reaction was detected in patients of the three groups.
","['after laparoscopic resection of colorectal cancer', '105 patients for the selective laparoscopic resection of colorectal cancer', 'patients after laparoscopic resection of colorectal cancer']","['postoperative acupoint application', 'acupoint application therapy', 'preoperative acupoint application']","['postoperative gastrointestinal function recovery, improves HRV and autonomous nerve function', 'VAS scores', 'adverse reactions', 'gastrointestinal function recovery and heart rate variability', 'time of the first postoperative exhaust and the time of the first postoperative defecation', 'time of first food intake', 'gastrointestinal function recovery and heart rate variability (HRV', 'HRV [standard deviation of NN intervals (SDNN) and the ratio of low-frequency power and high frequency power (LF/HF', 'time of the first postoperative exhaust, defecation and food intake, the score of visual analogue scale (VAS', 'adverse reaction', 'total score of gastrointestinal symptom rating scale (GSRS', 'total GSRS scores', 'SDNN and LF/LF']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",105.0,0.0140119,"No adverse reaction was detected in patients of the three groups.
","[{'ForeName': 'Meng-Wei', 'Initials': 'MW', 'LastName': 'Zhi', 'Affiliation': 'School of Nursing, Nanjing University of Chinese Medicine, Nanjing 210023, Jiangsu Province, China.'}, {'ForeName': 'Xin-Juan', 'Initials': 'XJ', 'LastName': 'Dai', 'Affiliation': 'Department of Nursing, 3Department of General Surgery, Jiangsu Provincial TCM Hospital, Nanjing 210029.'}, {'ForeName': 'Zhi-Wei', 'Initials': 'ZW', 'LastName': 'Jiang', 'Affiliation': 'Department of General Surgery, Jiangsu Provincial TCM Hospital, Nanjing 210029.'}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Xu', 'Affiliation': 'Department of Nursing, 3Department of General Surgery, Jiangsu Provincial TCM Hospital, Nanjing 210029.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Nursing, 3Department of General Surgery, Jiangsu Provincial TCM Hospital, Nanjing 210029.'}, {'ForeName': 'Rui-Yi', 'Initials': 'RY', 'LastName': 'Xie', 'Affiliation': 'Department of Nursing, 3Department of General Surgery, Jiangsu Provincial TCM Hospital, Nanjing 210029.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200327-k0003']
2494,32959590,[Efficacy and mechanism of fire needling bloodletting for lower extremity varicose veins].,"OBJECTIVE


To compare the clinical effect of lower extremity varicose veins between fire needling bloodletting and operation, and to explore the possible mechanism.
METHODS


A total of 60 patients were randomized into an observation group and a control group, 30 cases in each one. In the control group，the operation was adopted. The fire needling bloodletting was applied in the observation group, twice a week for 4 weeks. Before and after treatment, the venous clinical severity score (VCSS) and venous disability score (VDS) were recorded, the hemorheological indexes [blood viscosity, plasma viscosity, hematocrit, fibrinogen and erythrocyte sedimentation rate (ESR)], immune inflammatory response indexes[serum C-reactive protein (CRP), tumor necrosis factor-α(TNF-α) and interleukin-6 (IL-6)], vascular endothelial cell function indexes [the number of circulatingendothelial cell (CEC), plasma endothelin (ET-1) and NO)] and apoptosis indexes (Bcl-2, Bax and Caspase-3) were detected in the two groups.
RESULTS


Compared before treatment, the scores of VCSS and VDS, hemorheological indexes, immune inflammatory response indexes and levels of plasma NO after treatment were reduced in the two groups ( P <0.05). The level of serum Bax after treatment was reduced in the observation group ( P <0.05). The number of CEC and levels of plasma ET-1 after treatment were increased in the two groups ( P <0.05). The levels of serum Bcl-2 and Caspase-3 after treatment were increased in the observation group ( P <0.05). In the observation group, the scores of VCSS and VDS, hemorheological indexes，immune inflammatory response indexes, vascular endothelial cell function indexes and level of serum Bax after treatment were lower than the control group ( P <0.05), and the levels of Bcl-2 and Caspase-3 were higher than the control group ( P <0.05).
CONCLUSION


Fire needling bloodletting could effectively treat lower extremity varicose veins, and the mechanism may be related to the improvement of hemorheology, downregulation of immune inflammatory response, improvement of vascular endothelial cell function and inhibition of apoptosis.",2020,The levels of serum Bcl-2 and Caspase-3 after treatment were increased in the observation group ( P <0.05).,"['60 patients', 'lower extremity varicose veins']",['fire needling bloodletting'],"['hemorheological indexes [blood viscosity, plasma viscosity, hematocrit, fibrinogen and erythrocyte sedimentation rate (ESR)], immune inflammatory response indexes[serum C-reactive protein (CRP), tumor necrosis factor-α(TNF-α) and interleukin-6 (IL-6)], vascular endothelial cell function indexes [the number of circulatingendothelial cell (CEC), plasma endothelin (ET-1) and NO)] and apoptosis indexes (Bcl-2, Bax and Caspase-3', 'scores of VCSS and VDS, hemorheological indexes, immune inflammatory response indexes and levels of plasma', 'number of CEC and levels of plasma ET-1', 'scores of VCSS and VDS, hemorheological indexes，immune inflammatory response indexes, vascular endothelial cell function indexes and level of serum Bax', 'levels of Bcl-2 and Caspase-3', 'levels of serum Bcl-2 and Caspase-3', 'venous clinical severity score (VCSS) and venous disability score (VDS', 'level of serum Bax']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}]","[{'cui': 'C0014007', 'cui_str': 'Dismissed from job'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005848', 'cui_str': 'Blood viscosity'}, {'cui': 'C0427685', 'cui_str': 'Plasma viscosity measurement'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1257792', 'cui_str': 'Vascular Endothelial Cells'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079284', 'cui_str': 'Endothelin'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0376515', 'cui_str': 'bcl-2 Genes'}, {'cui': 'C0219474', 'cui_str': 'Bax Protein'}, {'cui': 'C0291573', 'cui_str': 'Caspase-3'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",60.0,0.0250705,The levels of serum Bcl-2 and Caspase-3 after treatment were increased in the observation group ( P <0.05).,"[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Gansu Provincial Hospital of TCM, Lanzhou 730050, China.'}, {'ForeName': 'Lian-Li', 'Initials': 'LL', 'LastName': 'Qiu', 'Affiliation': 'Gansu Provincial Hospital of TCM, Lanzhou 730050, China.'}, {'ForeName': 'Yan-Yi', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'Gansu Provincial Hospital of TCM, Lanzhou 730050, China.'}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Gu', 'Affiliation': 'Gansu Academy of TCM.'}, {'ForeName': 'Qiang-Guang', 'Initials': 'QG', 'LastName': 'Liu', 'Affiliation': 'Gansu Provincial Hospital of TCM, Lanzhou 730050, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190815-k0004']
2495,32959591,[Effect of electroacupuncture combined with  Yuyin  pill on sex hormone and Th2 cytokines in patients of decreased ovarian reserve function with liver-kidney  yin  deficiency].,"OBJECTIVE


To observe the effect of electroacupuncture (EA) combined with  Yuyin  pill on clinical symptoms, levels of serum sex hormone and Th2 cytokines in patients of decreased ovarian reserve function (DOR) with liver-kidney  yin  deficiency, and to compare the efficacy between EA combined with  Yuyin  pill and  Yuyin  pill alone.
METHODS


Sixty patients with DOR were randomly divided into an observation group (30 cases, 2 cases dropped off) and a control group (30 cases, 1 case dropped off). The patients in the control group were treated with  Yuyin  pill, 1 pill each time, 3 times a day. Based on the treatment of the control group, the patients in the observation group were additionally treated with acupuncture at Guanyuan (CV 4), Zhongji (CV 3), Guilai (ST 29), Zigong (EX-CA 1), Zusanli (ST 36), Sanyinjiao (SP 6), Taixi (KI 3) and Taichong (LR 3); EA was applied at bilateral Zusanli (ST 36) and Sanyinjiao (SP 6), with continuous wave, in frequency of 20 Hz and current intensity of 1 to 4 mA, for 20 min. The treatment was given 3 times a week. All the patients terminated treatment during menstrual period, and the treatment was given for 3 continuous menstrual cycles. The menstrual condition score and systemic symptom score were compared between the two groups before and after treatment. The levels of serum sex hormones on 2nd to 3rd day of menstruation, including follicle stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2), and the serums levels of interleukin (IL) -4 and IL-10 secreted by Th2 cytokines were compared between the two groups before and after treatment.
RESULTS


After the treatment, the menstruation condition scores and systemic symptom scores in the two groups were reduced ( P <0.05), and the scores in the observation group were lower than those in the control group ( P <0.05). After the treatment, the levels of serum FSH, LH and FSH/LH were reduced ( P <0.05), and the E2 levels were increased in the two groups ( P <0.05), and the levels of FSH, LH in the observation group were lower than those in the control group ( P <0.05), and the E2 level was higher than that in the control group ( P <0.05). After the treatment, the levels of serum IL-4 and IL-10 in the two groups were increased ( P <0.05), and the levels of IL-4 and IL-10 in the observation group were higher than those in the control group ( P <0.05).
CONCLUSION


EA combined with  Yuyin  pill could significantly improve menstruation, systemic symptoms and serum sex hormone levels in patients of decreased ovarian reserve function with liver-kidney  yin  deficiency, which may restore ovarian function by up-regulating the expression of Th2 cytokines.",2020,"After the treatment, the levels of serum FSH, LH and FSH/LH were reduced ( P <0.05), and the E2 levels were increased in the two groups ( P <0.05), and the levels of FSH, LH in the observation group were lower than those in the control group ( P <0.05), and the E2 level was higher than that in the control group ( P <0.05).","['patients of decreased ovarian reserve function (DOR) with liver-kidney  yin  deficiency', 'patients of decreased ovarian reserve function with liver-kidney  yin  deficiency', 'Sixty patients with DOR']","['electroacupuncture combined with  Yuyin  pill', 'EA combined with  Yuyin  pill and  Yuyin  pill alone', 'EA combined with  Yuyin  pill', 'electroacupuncture (EA) combined with  Yuyin  pill', 'acupuncture at Guanyuan (CV 4), Zhongji (CV 3), Guilai (ST 29), Zigong (EX-CA 1), Zusanli (ST 36), Sanyinjiao (SP 6), Taixi (KI 3) and Taichong (LR 3); EA']","['menstrual condition score and systemic symptom score', 'E2 level', 'levels of IL-4 and IL-10', 'levels of serum sex hormones', 'menstruation, systemic symptoms and serum sex hormone levels', 'E2 levels', 'levels of serum FSH, LH and FSH/LH', 'menstruation condition scores and systemic symptom scores', 'levels of FSH, LH', 'follicle stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2), and the serums levels of interleukin (IL) -4 and IL-10 secreted by Th2 cytokines', 'levels of serum IL-4 and IL-10']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0085257', 'cui_str': 'Yin deficiency'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0626533', 'cui_str': 'SP 6'}]","[{'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0455276', 'cui_str': 'Serum follicle stimulating hormone measurement'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",60.0,0.0257155,"After the treatment, the levels of serum FSH, LH and FSH/LH were reduced ( P <0.05), and the E2 levels were increased in the two groups ( P <0.05), and the levels of FSH, LH in the observation group were lower than those in the control group ( P <0.05), and the E2 level was higher than that in the control group ( P <0.05).","[{'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'Feng', 'Affiliation': 'First Affiliated Hospital of Heilongjiang University of CM, Harbin 150036, China.'}, {'ForeName': 'Zi-Qian', 'Initials': 'ZQ', 'LastName': 'Jia', 'Affiliation': 'Heilongjiang University of CM.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'First Affiliated Hospital of Heilongjiang University of CM, Harbin 150036, China.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Heilongjiang University of CM.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Chang', 'Affiliation': 'Heilongjiang University of CM.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Heilongjiang University of CM.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190925-0003']
2496,32959909,Progesterone for preterm birth prevention in women with short cervical length: outcomes in children at 2 years.,"OBJECTIVE


To evaluate, in children born to women with a short cervix, and otherwise low-risk , the long-term outcomes after antenatal vaginal progesterone versus placebo (follow-up of the Triple P trial).
METHODS


The Triple P trial randomized low risk women (n=80) with a short cervix at screening (≤30mm), to progesterone (n=41) or placebo (n=39). At 2'years corrected age children were invited for a neurodevelopmental assessment using the Bayley Scales of Infant and Toddler Development-third edition (BSID-III) and a neurological and physical examination by a blinded assessor. Parents filled out the Ages and Stages Questionnaire, the Child Behaviour Checklist (CBCL) and a general health questionnaire. The main outcome of interest was the mean BSID-III cognitive and motor score. Additionally, a composite score of abnormal developmental outcome included BSID-III <-1SD, CBCL in clinical range, parental reported physical problems (i.e. >'1 surgery or >'1 hospital admittance) or mortality. Our sample size, dictated by the original sample of the Triple P trial, gave us 80% power to detect a mean difference (MD) of 15 points (1SD) between groups for the BSID-III tests.
RESULTS


Of the 80 children born to the randomised women, 1 child in the progesterone group and 2 children in the placebo group died in the neonatal period. Follow-up data were obtained from 59/77 children (77%) and BSID-III outcomes in 57 children (n=28 progesterone vs n=29 placebo) born at a median gestational age (GA) of 38+6'weeks (IQR 37+3; 40+1'weeks) with a median birthweight of 3240 grams (IQR 2785; 3620grams), Mean BSID-III cognitive developmental scores were 101.6 and 105.0 , mean difference (MD) [95% Confidence Interval (CI)] -3.4 [ 95% -9.3 to 2.6], p=0.29 ) while mean motor scores were 102.4 and 107.3 , MD -4.9 [95% CI -11.2 to 1.4], p='0.13) for progesterone and placebo, respectively. No differences in physical outcomes (including genital and neurological examination) were seen between groups.
CONCLUSION


In this sample of children born to low risk women with a short cervix at screening no relevant differences in neurodevelopmental, behavioural, health care related and physical outcomes were found in the offspring between those exposed to vaginal progesterone or placebo. This article is protected by copyright. All rights reserved.",2020,"In this sample of children born to low risk women with a short cervix at screening no relevant differences in neurodevelopmental, behavioural, health care related and physical outcomes were found in the offspring between those exposed to vaginal progesterone or placebo.","['follow-up of the Triple P trial', '80 children born to the randomised women, 1 child in the', 'n=39', ""At 2'years corrected age children"", 'children born to women with a short cervix, and otherwise low-risk , the long-term outcomes after antenatal', 'women with short cervical length', 'low risk women (n=80) with a short cervix at screening (≤30mm), to progesterone (n=41) or']","['progesterone', 'vaginal progesterone versus placebo', 'Progesterone', 'placebo']","['physical outcomes (including genital and neurological examination', 'neurodevelopmental, behavioural, health care related and physical outcomes', 'mean motor scores', 'Child Behaviour Checklist (CBCL) and a general health questionnaire', 'BSID-III', 'Mean BSID-III cognitive developmental scores', 'mean BSID-III cognitive and motor score', 'Bayley Scales of Infant and Toddler Development-third edition (BSID-III) and a neurological and physical examination']","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",80.0,0.27062,"In this sample of children born to low risk women with a short cervix at screening no relevant differences in neurodevelopmental, behavioural, health care related and physical outcomes were found in the offspring between those exposed to vaginal progesterone or placebo.","[{'ForeName': 'C J J', 'Initials': 'CJJ', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam UMC, Academic Medical Center, 1105DE, Amsterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""van 't Hooft"", 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam UMC, Academic Medical Center, Amsterdam, 1105DE, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schneeberger', 'Affiliation': 'Amsterdam UMC, Academic Medical Center, 1105DE, Amsterdam, The Netherlands.'}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'van der Lee', 'Affiliation': ""Pediatric clinical Research Office, Emma Children's Hospital, Amsterdam UMC and Knowledge Institute of the Dutch Association of Medical Specialists, Utrecht, The Netherlands.""}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Simons', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam UMC, Academic Medical Center, 1105DE, Amsterdam, The Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'van Os', 'Affiliation': ""Wilhelmina Children's Hospital, University Medical Centre Utrecht, 3584EA, Utrecht, The Netherlands.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Ven', 'Affiliation': 'Midwifery practice Velp, 6883AX, Velp, The Netherlands.'}, {'ForeName': 'C J M', 'Initials': 'CJM', 'LastName': 'de Groot', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam UMC, Academic Medical Center, 1105DE, Amsterdam, The Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, 3800, Australia.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'van Wassenaer-Leemhuis', 'Affiliation': ""Pediatric Clinical Research Office, Emma Children's Hospital, Amsterdam UMC, Academic Medical Center, 1105DE, Amsterdam, The Netherlands.""}]",Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology,['10.1002/uog.23126']
2497,32959996,"Two-year outcomes of Whānau Pakari, a multi-disciplinary assessment and intervention for children and adolescents with weight issues: A randomized clinical trial.","OBJECTIVE


To determine whether 12-month BMI SDS reductions persisted at 24 months in a multi-disciplinary assessment and intervention program for children and adolescents with obesity, and whether secondary outcomes improved.
METHODS


This was a community-based 12-month RCT in Aotearoa/New Zealand. Eligible participants were aged 5 to 16 years with BMI ≥98th centile or BMI >91st centile with weight-related comorbidities. The low-intensity control received comprehensive home-based baseline assessments and advice, and 6-monthly follow-up. The high-intensity intervention received the same assessments and advice, but also weekly multidisciplinary sessions. Primary outcome was BMI SDS at 12 months. Secondary outcomes included cardiovascular and metabolic markers.
RESULTS


121 participants (60% of participants at baseline) were assessed at 24 months. BMI SDS reduction at 12 months was lost at 24 months in the modified intention-to-treat analysis [Control -0.03 (95%CI -0.14, 0.09) and Intervention -0.02 (-0.12, 0.08); P = .93]. However, sweet drink intake was reduced, water intake increased, and there were improvements in cardiovascular fitness in the high-intensity intervention. ≥70% attendance in the high-intensity intervention resulted in a persistent BMI SDS reduction of -0.22 after 24 months (95%CI -0.38, -0.06).
CONCLUSIONS


This trial was negative in terms of primary outcome at 24 months. However, high engagement led to sustained treatment effect, and there were multiple improvements in health measures.",2020,"≥70% attendance in the high-intensity intervention resulted in a persistent BMI SDS reduction of -0.22 after 24 months (95%CI -0.38, -0.06).
","['Eligible participants were aged 5 to 16\u2009years with BMI ≥98th centile or BMI\u2009>91st centile with weight-related comorbidities', '121 participants (60% of participants at baseline) were assessed at 24\u2009months', 'children and adolescents with weight issues', 'children and adolescents with obesity']","['Whānau Pakari, a multi-disciplinary assessment and intervention']","['health measures', 'persistent BMI SDS reduction', 'cardiovascular and metabolic markers', 'BMI SDS', 'water intake', 'cardiovascular fitness', 'BMI SDS reductions', 'BMI SDS reduction']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}]",121.0,0.220363,"≥70% attendance in the high-intensity intervention resulted in a persistent BMI SDS reduction of -0.22 after 24 months (95%CI -0.38, -0.06).
","[{'ForeName': 'Yvonne C', 'Initials': 'YC', 'LastName': 'Anderson', 'Affiliation': 'Department of Paediatrics, Taranaki District Health Board, New Plymouth, New Zealand.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Wynter', 'Affiliation': 'Department of Paediatrics, Taranaki District Health Board, New Plymouth, New Zealand.'}, {'ForeName': 'Niamh A', 'Initials': 'NA', 'LastName': ""O'Sullivan"", 'Affiliation': 'Department of Paediatrics, Taranaki District Health Board, New Plymouth, New Zealand.'}, {'ForeName': 'Cervantée E K', 'Initials': 'CEK', 'LastName': 'Wild', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Cameron C', 'Initials': 'CC', 'LastName': 'Grant', 'Affiliation': 'Department of Paediatrics, Child and Youth Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tami L', 'Initials': 'TL', 'LastName': 'Cave', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'José G B', 'Initials': 'JGB', 'LastName': 'Derraik', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}]",Pediatric obesity,['10.1111/ijpo.12693']
2498,32960007,Salbutamol combined with budesonide in treatment of pediatric bronchial asthma and its effect on eosinophils.,"BACKGROUND


To investigate and discuss the salbutamol combined with budesonide in treatment of pediatric bronchial asthma (BA) and its effect on eosinophils (EOS).
METHODS


98 BA children admitted and treated in our hospital from July 2016 to June 2017 were collected and divided into control group (n=49) and observation group (n=49) according to random number table. The children in control group were treated with budesonide and those in observation group were treated with salbutamol combined with budesonide. The clinical efficacy, pulmonary functions and levels of T-lymphocyte subsets [including cluster of differentiation 3 (CD3)+, CD4+, CD8+ and CD4+/CD8+] in the immune system between two groups were compared after the treatment; the levels of eosinophil cationic protein (ECP) and eotaxin in the children were compared before the treatment and at 1, 4 and 8 weeks after the treatment; the changes in EOS counts in blood and induced sputum of the children before and after the treatment were compared, and the EOS apoptosis rate was compared at 1, 4 and 8 weeks after the treatment.
RESULTS


The effective rate of treatment in observation group was significantly higher than that in control group (p<0.05). After the treatment, the indexes of pulmonary function in observation group were obviously better than those in control group (p<0.05). Compared with those in control group, the levels of CD3+, CD4+ and CD4+/CD8+ of the children in observation group were elevated remarkably, while the CD8+ level was lowered (p<0.05). The levels of ECP and eotaxin in the two groups were decreased after the treatment compared with those before the treatment, and the levels in observation group were superior to those in control group (p<0.05). After the treatment, the EOS counts of the both groups of children were lower than those before the treatment, and the decrease in observation group was more notable than that in control group. At 1, 4 and 8 weeks after the treatment, the EOS apoptosis rate in observation group was obviously higher than that in control group (p<0.05).
CONCLUSIONS


The treatment of salbutamol combined with budesonide for pediatric BA has significant therapeutic effects; it can restore the pulmonary functions rapidly and improve the immunity of the lung, reduce the levels of eotaxin, ECP and EOS of the child patients and promote EOS apoptosis.",2020,The effective rate of treatment in observation group was significantly higher than that in control group (p<0.05).,"['pediatric bronchial asthma (BA', '98 BA children admitted and treated in our hospital from July 2016 to June 2017 were collected and divided into control group (n=49) and observation group (n=49) according to random number table']","['salbutamol combined with budesonide', 'Salbutamol combined with budesonide', 'budesonide']","['levels of ECP and eotaxin', 'clinical efficacy, pulmonary functions and levels of T-lymphocyte subsets [including cluster of differentiation 3 (CD3)+, CD4+, CD8+ and CD4+/CD8', 'EOS counts', 'EOS apoptosis rate', 'levels of eosinophil cationic protein (ECP) and eotaxin', 'levels of CD3+, CD4+ and CD4+/CD8', 'EOS counts in blood and induced sputum', 'CD8+ level', 'eosinophils', 'pediatric bronchial asthma', 'indexes of pulmonary function', 'effective rate']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0950373', 'cui_str': 'Eosinophilic cationic protein'}, {'cui': 'C0250604', 'cui_str': 'Eotaxin-1'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0080202', 'cui_str': 'T-Cell Subsets'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",98.0,0.0171781,The effective rate of treatment in observation group was significantly higher than that in control group (p<0.05).,"[{'ForeName': 'Suihua', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Guangdong Second Provincial General Hospital, Guangzhou, P.R.China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Mei', 'Affiliation': 'Department of Pharmacy, Guangdong Second Provincial General Hospital, Guangzhou, P.R.China - qal5uw@163.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Qian', 'Affiliation': ""Department of Pharmacy, Children's Hospital of Yuexiu District, Guangzhou, P.R.China.""}, {'ForeName': 'Xianghong', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Pharmacy, Children's Hospital of Yuexiu District, Guangzhou, P.R.China.""}, {'ForeName': 'Cuimiao', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'Department of Pharmacy, Guangdong Second Provincial General Hospital, Guangzhou, P.R.China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Quan', 'Affiliation': 'Department of Pharmacy, Guangdong Second Provincial General Hospital, Guangzhou, P.R.China.'}]",Minerva pediatrica,['10.23736/S0026-4946.20.06003-X']
2499,32960155,Using Bodyweight as Resistance Can Be a Promising Avenue to Promote Interval Training: Enjoyment Comparisons to Treadmill-Based Protocols.,"Purpose : Even though multiple training methods appear to be effective to improve cardiorespiratory fitness, they also need to be perceived as tolerable or enjoyable by exercisers to maximize long-term behavioral maintenance. Therefore, the purpose of the current study was to compare perceived enjoyment between whole-body interval training (SIT-WB), treadmill-based interval training (SIT-T) and moderate-intensity continuous training (MICT).  Method : Forty-one healthy adult men (age: 23.7 ± 0.7 years, height: 1.79 ± 0.01 m, body mass: 78.5 ± 1.7 kg; V̇O 2max : 46.7 ± 7.3 ml.kg -1 .min -1 ) were randomly assigned to SIT-WB, SIT-T, or MICT and underwent 16 weeks of training (3x/w). SIT-WB and SIT-T completed eight 20 s bouts interspersed by 10 s passive recovery, differing as to the exercise mode performed (i.e., calisthenics exercises and treadmill running, respectively) whereas MICT participants ran for 30 min at an intensity below the second ventilatory threshold. Perceived enjoyment was assessed 10 min post-exercise at weeks 1, 5, 9, 13, and 16, using the Physical Activity Enjoyment Scale.  Results : Compliance was high (~90%) across all three training groups ( p  = .803). All training modes were rated as enjoyable and no significant within- (F (4, 152)  = 1.132,  p  = .344) or between-group (F (2, 38)  = 0.662,  p  = .521) differences were found during the intervention period.  Conclusions : These results suggest that SIT-WB can be employed as an enjoyable low-cost alternative to traditional treadmill-based SIT and MICT for up to 16 weeks.",2020,Compliance was high (~90%) across all three training groups ( p  = .803).,"['Method : Forty-one healthy adult men (age: 23.7\xa0± 0.7\xa0years, height: 1.79\xa0± 0.01 m, body mass: 78.5\xa0± 1.7 kg; V̇O 2max : 46.7\xa0± 7.3']","['MICT participants ran for 30\xa0min at an intensity below the second ventilatory threshold', 'whole-body interval training (SIT-WB), treadmill-based interval training (SIT-T) and moderate-intensity continuous training (MICT']","['Physical Activity Enjoyment Scale', 'Perceived enjoyment', 'Compliance']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517512', 'cui_str': '1.7'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037216', 'cui_str': 'SITS'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",41.0,0.0125718,Compliance was high (~90%) across all three training groups ( p  = .803).,"[{'ForeName': 'Gustavo Z', 'Initials': 'GZ', 'LastName': 'Schaun', 'Affiliation': 'Federal University of Pelotas.'}, {'ForeName': 'Cristine L', 'Initials': 'CL', 'LastName': 'Alberton', 'Affiliation': 'Federal University of Pelotas.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1817293']
2500,32960272,CYP2B6 Genotype and Weight Gain Differences Between Dolutegravir and Efavirenz.,"BACKGROUND


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


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


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


CYP2B6 metaboliser genotype was associated with weight gain in PLWH starting efavirenz-based ART. Weight gain was similar between CYP2B6 extensive metabolizers in the efavirenz arm and in the dolutegravir arm, suggesting that impaired weight gain among CYP2B6 slow or intermediate metabolizers could explain the increased weight gain on dolutegravir compared with efavirenz observed in ADVANCE and other studies.",2020,"In the efavirenz arm CYP2B6 metaboliser genotype was associated with weight gain (P = .009), with extensive metabolizers gaining the most weight, and with changes in regional fat in women, but not in men.","['342 participants in the dolutegravir arm and 168 in the efavirenz arm who consented to genotyping', 'people living with human immunodeficiency virus (HIV; PLWH) starting efavirenz-based antiretroviral therapy (ART']","['efavirenz /emtricitabine/tenofovir disoproxil fumarate (TDF) and dolutegravir/emtricitabine/TDF arms', 'efavirenz', 'Efavirenz']","['weight gain', 'Weight gain', 'weight and regional fat on DXA', 'CYP2B6 Genotype and Weight Gain Differences', 'baseline CD4 count, baseline human immunodeficiency virus type 1 (HIV-1) RNA, and CYP2B6 metaboliser genotype']","[{'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C2929052', 'cui_str': 'tenofovir disoproxil and emtricitabine'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0534137', 'cui_str': 'CYP2B6 protein, human'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",342.0,0.122371,"In the efavirenz arm CYP2B6 metaboliser genotype was associated with weight gain (P = .009), with extensive metabolizers gaining the most weight, and with changes in regional fat in women, but not in men.","[{'ForeName': 'Rulan', 'Initials': 'R', 'LastName': 'Griesel', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Maartens', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Chirehwa', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Simiso', 'Initials': 'S', 'LastName': 'Sokhela', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Godspower', 'Initials': 'G', 'LastName': 'Akpomiemie', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Moorhouse', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Phumla', 'Initials': 'P', 'LastName': 'Sinxadi', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1073']
2501,32960309,Outcomes after nonoperatively treated non-displaced Lisfranc injury: a retrospective case series of 55 patients.,"BACKGROUND


Current knowledge of the role of the nonoperative treatment of Lisfranc injuries is based on a few retrospective case series. Hence, consensus on which patients can be treated nonoperatively does not exist. The aim of this study was to investigate outcomes after nonoperative treatment of Lisfranc injuries.
METHODS


In this study, patients were collected by recruiting all computer tomography-confirmed Lisfranc injuries treated during a 5-year period at a major trauma hospital. Between 2 and 6 years after suffering the injury, patients completed the visual analogue scale foot and ankle questionnaire.
RESULTS


In total, 55 patients returned adequately completed questionnaires and were included in the study. Of those, 22 patients had avulsion fractures and 33 had simple non-displaced intra-articular fractures. Of these patients, 30 (55%) scored over 90 points in both the pain and function subscales of the VAS-FA, and 35 (64%) scored over 90 points overall. In addition, three (5%) patients scored under 60 points in both the pain and function subscales of the VAS-FA, and four (7%) scored under 60 points overall. Only one patient with avulsion fractures underwent secondary surgery.
CONCLUSION


Nonoperative treatment has a role in the treatment of Lisfranc injuries, and the results of our study support the view that avulsion and simple intra-articular fractures with < 2 mm of displacement can be treated nonoperatively with high functional outcomes. The results of nonoperative and operative treatment should be compared in a prospective randomized controlled study setting in future studies.
LEVEL OF EVIDENCE


IV, retrospective case series.",2020,"Of these patients, 30 (55%) scored over 90 points in both the pain and function subscales of the VAS-FA, and 35 (64%) scored over 90 points overall.","['22 patients had avulsion fractures and 33 had simple non-displaced intra-articular fractures', 'patients were collected by recruiting all computer tomography-confirmed Lisfranc injuries treated during a 5-year period at a major trauma hospital', '55 patients', '55 patients returned adequately completed questionnaires and were included in the study']",[],"['visual analogue scale foot and ankle questionnaire', 'pain and function subscales of the VAS-FA']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332758', 'cui_str': 'Avulsion fracture'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0332715', 'cui_str': 'Fracture, intra-articular'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C4523968', 'cui_str': 'Lisfranc injury'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0218586,"Of these patients, 30 (55%) scored over 90 points in both the pain and function subscales of the VAS-FA, and 35 (64%) scored over 90 points overall.","[{'ForeName': 'Ville T', 'Initials': 'VT', 'LastName': 'Ponkilainen', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine and Life Sciences and Tampere University Hospital, University of Tampere, Teiskontie 35, PL2000, 33521, Tampere, Finland. ville.ponkilainen@tuni.fi.'}, {'ForeName': 'Nikke', 'Initials': 'N', 'LastName': 'Partio', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine and Life Sciences and Tampere University Hospital, University of Tampere, Teiskontie 35, PL2000, 33521, Tampere, Finland.'}, {'ForeName': 'Essi E', 'Initials': 'EE', 'LastName': 'Salonen', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine and Life Sciences and Tampere University Hospital, University of Tampere, Teiskontie 35, PL2000, 33521, Tampere, Finland.'}, {'ForeName': 'Heikki-Jussi', 'Initials': 'HJ', 'LastName': 'Laine', 'Affiliation': 'Pohjola Sairaala, Kelloportinkatu 1, 33100, Tampere, Finland.'}, {'ForeName': 'Heikki M', 'Initials': 'HM', 'LastName': 'Mäenpää', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine and Life Sciences and Tampere University Hospital, University of Tampere, Teiskontie 35, PL2000, 33521, Tampere, Finland.'}, {'ForeName': 'Ville M', 'Initials': 'VM', 'LastName': 'Mattila', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine and Life Sciences and Tampere University Hospital, University of Tampere, Teiskontie 35, PL2000, 33521, Tampere, Finland.'}, {'ForeName': 'Heidi H', 'Initials': 'HH', 'LastName': 'Haapasalo', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine and Life Sciences and Tampere University Hospital, University of Tampere, Teiskontie 35, PL2000, 33521, Tampere, Finland.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03599-w']
2502,32960313,Evaluation of effectiveness and stability of aligner treatments using the Peer Assessment Rating Index.,"AIMS


The aims of this study were to measure treatment effects of aligner treatments in adult patients directly after treatment and the stability of these effects after a short-term retention period using the Peer Assessment Rating (PAR) Index.
METHODS


This double-center trial consecutively screened 98 adult patients of whom 33 patients were treated according to predefined inclusion and exclusion criteria. The study sample was shown to be representative for adult orthodontic reality with regard to gender, age, and distribution of malocclusion type. Malocclusion severity was rated by using the PAR Index measured at baseline (T0), after finishing orthodontic treatment with Invisalign® (T1; Align Technology Inc., Santa Clara, CA, USA) and after a mean retention period of 10 months (T2). Furthermore, to better understand the observed treatment modality, specific treatment characteristics were recorded and analyzed.
RESULTS


The average PAR score at T0 was 22.18 (standard deviation [SD] ± 8.68). Posttreatment PAR score was 4.64 (SD ± 4.23) at T1 and was stable after a retention period of 10.07 months at T2 (SD ± 126.80 days; PAR 4.36, SD ± 3.93). All of the study cases showed a significant reduction of the total PAR score between T0 and T1 (p < 0.001), but no further difference between T1 and T2 (PAR 4.64 vs. 4.36). Cases were either classified 'improved' (n = 23) or 'greatly improved' (n = 10); no case was classified into the third PAR Index category 'worse or no different'. On average, 72 aligners (SD ± 22) with 12 attachments per treatment (SD ± 4) were used to align teeth. Six patients needed a case refinement with a mean of 23 (SD ± 8) further aligners. The maximum number of needed ClinCheck® (Align Technology Inc., Santa Clara, CA, USA) treatment plan revisions was 18 (mean 7, SD ± 4).
CONCLUSION


The detected improvement rate indicated a good standard of orthodontic treatment using aligners. Treatment effects were stable throughout a short-term retention period using a specific retention protocol. Effectiveness and stability were equally achieved in mild, moderate, and rather severe cases within this consecutive sample. A critical focus should be placed on accurate treatment planning in order to make tooth movements predictable, realistic, and stable.",2020,"All of the study cases showed a significant reduction of the total PAR score between T0 and T1 (p < 0.001), but no further difference between T1 and T2 (PAR 4.64 vs. 4.36).","['98\xa0adult patients of whom 33\xa0patients were treated according to predefined inclusion and exclusion criteria', 'adult orthodontic reality with regard to gender, age, and distribution of malocclusion type', 'adult patients']",[],"['Effectiveness and stability', 'total PAR score', 'average PAR score', 'Peer Assessment Rating (PAR) Index', 'Posttreatment PAR score', 'Malocclusion severity', 'PAR Index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429164', 'cui_str': 'Peer assessment rating (orthodontic index)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024636', 'cui_str': 'Malocclusion'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0589654,"All of the study cases showed a significant reduction of the total PAR score between T0 and T1 (p < 0.001), but no further difference between T1 and T2 (PAR 4.64 vs. 4.36).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Graf', 'Affiliation': 'Department of Orthodontics, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Kerpener Str.\xa032, 50931, Cologne, Germany. isabelle.graf@uk-koeln.de.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Puppe', 'Affiliation': 'Department of Orthodontics, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Kerpener Str.\xa032, 50931, Cologne, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Schwarze', 'Affiliation': 'Private Orthodontic Practice, Cologne, Germany.'}, {'ForeName': 'Karolin', 'Initials': 'K', 'LastName': 'Höfer', 'Affiliation': 'Department of Operative Dentistry and Periodontology, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hildegard', 'Initials': 'H', 'LastName': 'Christ', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Braumann', 'Affiliation': 'Department of Orthodontics, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Kerpener Str.\xa032, 50931, Cologne, Germany.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-020-00249-z']
2503,32960329,"Transarterial chemoembolization of colorectal cancer liver metastasis: improved tumor response by DSM-TACE versus conventional TACE, a prospective, randomized, single-center trial.","OBJECTIVES


To prospectively evaluate the therapy response of third-line TACE with DSM or lipiodol in the treatment of CRLM using MRI.
METHODS


In this prospective, randomized, single-center trial, patients were randomly assigned to receive TACE therapy with either lipiodol or DSM as the embolization agent. Therapy response was evaluated using MRI. Local tumor response was determined according to RECIST 1.1, and survival data was analyzed using the Kaplan-Meier estimator.
RESULTS


Fifty patients (35 male, 15 female) were randomized and included in the survival analysis, whereas 31 patients completed therapy and were considered for evaluation of tumor responses (cTACE: n = 13, DSM-TACE: n = 18). In the cTACE group, PR was observed in 23%, SD in 15%, and PD in 62%. In the DSM-TACE-group, PR was observed in 22% of patients, SD in 56%, and PD in 22% (p = 0.047). In addition, the DSM-TACE group showed statistically significant tumor volume reduction (p = 0.006). Median apparent diffusion coefficient values were not significantly different between both groups at baseline (p = 0.26) and study endpoint (p = 0.83). Median survival in the cTACE group was 13 months (95% confidence interval, range 5-40 months) compared to 16 months (95% confidence interval, range 1-48 months) in the DSM-TACE group, exhibiting no statistically significant difference (p = 0.75).
CONCLUSION


DSM-TACE showed a significant difference reducing tumor volume and in tumor response according to RECIST 1.1 compared to cTACE. Thus, patients with CRLM might not only benefit from short embolization effect of DSM-TACE but also from better tumor responses. Apparent diffusion coefficients were not significantly different between both groups and cannot be used as a biomarker for monitoring for therapeutic effect of TACE.
KEY POINTS


• To our knowledge, this is the first prospective study that directly compared cTACE and DSM-TACE in patients with CRLM. • DSM-TACE showed a significant difference reducing tumor volume (p = 0.006) and in tumor response according to RECIST 1.1 (p = 0.047) compared to cTACE. • Survival analysis showed a median survival of 13 months in the cTACE group compared to 16 months in the DSM-TACE group (p = 0.75).",2020,DSM-TACE showed a significant difference reducing tumor volume (p = 0.006) and in tumor response according to RECIST 1.1 (p = 0.047) compared to cTACE.,"['colorectal cancer liver metastasis', '31 patients completed therapy and were considered for evaluation of tumor responses (cTACE: n\u2009=\u200913, DSM-TACE: n\u2009=\u200918', 'Fifty patients (35 male, 15 female', 'patients with CRLM']","['DSM-TACE', 'Transarterial chemoembolization', 'TACE therapy with either lipiodol or DSM', 'DSM or lipiodol', 'cTACE', 'DSM-TACE versus conventional TACE', 'cTACE and DSM-TACE']","['Median apparent diffusion coefficient values', 'tumor volume reduction', 'tumor response', 'Median survival', 'survival data', 'tumor volume and in tumor response', 'Local tumor response', 'Therapy response', 'PR', 'tumor volume', 'median survival']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0529196', 'cui_str': 'Tumor Necrosis Factor-alpha Converting Enzyme'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0529196', 'cui_str': 'Tumor Necrosis Factor-alpha Converting Enzyme'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0947677', 'cui_str': 'Lipiodol UltraFluid'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.0129,DSM-TACE showed a significant difference reducing tumor volume (p = 0.006) and in tumor response according to RECIST 1.1 (p = 0.047) compared to cTACE.,"[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Vogl', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Marko', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Marcel C', 'Initials': 'MC', 'LastName': 'Langenbach', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Nagy N N', 'Initials': 'NNN', 'LastName': 'Naguib', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Filmann', 'Affiliation': 'Institute of Biostatistics and Mathematical Modeling, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Hammerstingl', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Gruber-Rouh', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt, Germany. tgruberrouh@googlemail.com.'}]",European radiology,['10.1007/s00330-020-07253-2']
2504,32960347,Minimally invasive surgery versus an arthroscopic procedure for the first metatarsophalangeal arthrodesis: A comparative study of the effectiveness and safety profile.,"INTRODUCTION


First metatarsophalangeal (MTP) arthrodesis is a common procedure for treating degeneration in the MTP joint. Open arthrodesis is a conventional procedure that provides acceptable results but is more invasive than minimally invasive or arthroscopic arthrodesis. However, little is known about the different outcomes between minimally invasive surgery (MIS) and arthroscopic surgery (AS) for MTP arthrodesis. This study was performed to compare the outcomes of the first MTP joint preparation for arthrodesis regarding the effectiveness of articular surface preparation and safety between MIS and the arthroscopic procedure in cadaveric specimens.
METHODS


Sixteen cadaveric feet were collected in this study from eight cadavers. The potential exclusion criteria were significantly decomposed or deformed joint. All feet were randomly allocated into two groups, eight feet for the MIS (under fluoroscopic control) group and eight feet for the arthroscopic group. One foot in the AS group was excluded because the position of an arthroscopic portal was incorrect. All feet were operated on by four fellowship-trained foot and ankle orthopedic surgeons who also had prior clinical experience with the arthroscopic and minimal invasive procedure. Following a complete procedure in each specimen, all feet were dissected and the areas of joint preparation on the metatarsal and phalangeal sides were recorded via photography and the ImageJ program. Injury to the adjacent structure was noted in each specimen. All data were analyzed via the IBM SPSS program version 22 and GraphPad to compare the outcomes between the two groups.
RESULTS


The average age of the cadavers was 68.6 ± 12.3 years. The average areas of joint preparation on the metatarsal and phalangeal sides were 136.97 and 99.08 mm 2 , respectively. The average areas of joint preparation on the metatarsal sides were 154.26 and 117.21 mm 2  in the MIS and arthroscopic groups, respectively (p value = 0.353). The average areas of joint preparation on the phalangeal sides were 82.46 and 118.08 mm 2  in the MIS and arthroscopic groups, respectively (p value = 0.151). Regarding the ratio of prepared area/mean estimated fusion contact area, there was no significant difference of a ratio on metatarsal side with p value as 0.285. However, a higher level of ratio on phalangeal side was found in the arthroscopic group with p value as 0.085. For the safety profiles, the rate of adjacent injury was insignificantly higher in the MIS group (37.5%) than the arthroscopic group (0%) (p value = 0.20). All injuries were found at the extensor hallucis longus tendon.
CONCLUSIONS


There were no significant differences of the effectiveness of articular surface preparation between the MIS and arthroscopic groups. However, the arthroscopic procedure seemed to provide higher rate of prepared surface area on phalangeal side and be safer to the adjacent structures than MIS for this arthrodesis.",2020,There were no significant differences of the effectiveness of articular surface preparation between the MIS and arthroscopic groups.,"['All feet were operated on by four fellowship-trained foot and ankle orthopedic surgeons who also had prior clinical experience with the arthroscopic and minimal invasive procedure', 'cadaveric specimens', 'first metatarsophalangeal arthrodesis', 'Sixteen cadaveric feet were collected in this study from eight cadavers']","['arthroscopic procedure', 'MIS (under fluoroscopic control', 'Minimally invasive surgery', 'First metatarsophalangeal (MTP) arthrodesis', 'minimally invasive surgery (MIS) and arthroscopic surgery (AS']","['rate of adjacent injury', 'higher level of ratio on phalangeal side', 'effectiveness of articular surface preparation', 'average areas of joint preparation on the metatarsal sides']","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0188832', 'cui_str': 'Metatarsophalangeal fusion'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}]","[{'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0188832', 'cui_str': 'Metatarsophalangeal fusion'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}]","[{'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0025584', 'cui_str': 'Metatarsal bone structure'}, {'cui': 'C0441987', 'cui_str': 'Side'}]",,0.0176531,There were no significant differences of the effectiveness of articular surface preparation between the MIS and arthroscopic groups.,"[{'ForeName': 'Chayanin', 'Initials': 'C', 'LastName': 'Angthong', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand. chatthara@yahoo.com.'}, {'ForeName': 'Prasit', 'Initials': 'P', 'LastName': 'Rajbhandari', 'Affiliation': 'Department of Orthopaedics, Manmohan Memorial Teaching Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Henry Ricardo', 'Initials': 'HR', 'LastName': 'Handoyo', 'Affiliation': 'Surabaya Orthopedi and Traumatology, Faculty of Medicine Widya Mandala Catholic University, Surabaya, Indonesia.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02788-y']
2505,32960350,A randomised trial to assess the educational benefit of a smartphone otoscope in undergraduate medical training.,"PURPOSE


Competent otoscopy is a key otolaryngology skill for a broad range of medical careers, yet undergraduate's confidence to perform otoscopy is reported as low. Smartphone otoscopes have been suggested to improve undergraduates learning of normal eardrum anatomy because unlike the traditional otoscope, the learner and educator share the same image. This study aimed to evaluate whether a smartphone otoscope could enhance medical undergraduates recognition of common ear pathology.
METHODS


52 medical students were randomised into a standard group that used a traditional otoscope and an intervention group that used a smartphone otoscope. Both groups received a short didactic presentation on the recognition of common ear pathologies and were asked to diagnose four simulated pathologies. Both groups received feedback and guidance on how to better visualise the tympanic membrane. Force response items and 5-point Likert scales loaded on an electronic platform recorded their diagnosis and their perceptions towards the otoscope.
RESULTS


The smartphone-group (n = 20) had higher overall rates of correct diagnosis compared to control (n = 22) (84% vs. 39%, p = < 0.001). Only the grommet station did not show a significant improvement between the two groups (100% vs. 91%, p = 0.49). 90% (n = 20) of participants felt the smartphone otoscope was preferential for their learning. The same number expressed that they want to use it in future learning. The remainder were indifferent.
CONCLUSIONS


The smartphone otoscope enabled learners to better observe and recognise middle ear pathology. This popular learning tool has the potential to accelerate the learning curve of otoscopy and therefore improve the proficiency of future doctors at recognising middle ear diseases.",2020,"The smartphone-group (n = 20) had higher overall rates of correct diagnosis compared to control (n = 22) (84% vs. 39%, p = < 0.001).","['undergraduate medical training', '52 medical students']","['traditional otoscope and an intervention group that used a smartphone\xa0otoscope', 'smartphone\xa0otoscope', 'smartphone otoscope', 'short didactic presentation']",['overall rates of correct diagnosis'],"[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0182098', 'cui_str': 'Otoscope'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",52.0,0.0350001,"The smartphone-group (n = 20) had higher overall rates of correct diagnosis compared to control (n = 22) (84% vs. 39%, p = < 0.001).","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Schuster-Bruce', 'Affiliation': ""Department of Ear, Nose and Throat, Head and Neck surgery, St George's University Hospitals Foundation Trust, London, UK. James.schuster.bruce@gmail.com.""}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': ""Department of Ear, Nose and Throat, Head and Neck surgery, St George's University Hospitals Foundation Trust, London, UK.""}, {'ForeName': 'Minh', 'Initials': 'M', 'LastName': 'Van', 'Affiliation': ""St George's University, London, UK.""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Rogel-Salazar', 'Affiliation': 'Blackett Laboratory, Department of Physics, Imperial College London, London, UK.'}, {'ForeName': 'Enyinnaya', 'Initials': 'E', 'LastName': 'Ofo', 'Affiliation': ""Department of Ear, Nose and Throat, Head and Neck surgery, St George's University Hospitals Foundation Trust, London, UK.""}, {'ForeName': 'Eamon', 'Initials': 'E', 'LastName': 'Shamil', 'Affiliation': ""Department of Ear, Nose and Throat, Head and Neck surgery, St George's University Hospitals Foundation Trust, London, UK.""}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06373-1']
2506,32960408,Early Tumor Shrinkage and Depth of Response in the Second-Line Treatment for KRAS exon2 Wild-Type Metastatic Colorectal Cancer: An Exploratory Analysis of the Randomized Phase 2 Trial Comparing Panitumumab and Bevacizumab in Combination with FOLFIRI (WJOG6210G).,"BACKGROUND


Predictive markers for the clinical outcomes of second-line treatment in patients with metastatic colorectal cancer (mCRC) remain unclear.
OBJECTIVE


This retrospective biomarker study was conducted to explore predictive markers for patients with KRAS exon 2 wild-type mCRC who were treated with FOLFIRI plus panitumumab (Pani) or bevacizumab (Bev) in the WJOG6210G trial.
PATIENTS AND METHODS


The associations of early tumor shrinkage (ETS), tumor location, and VEGF-D with progression-free survival (PFS) and overall survival (OS) were analyzed using a Cox proportional hazards model. Spearman's correlation coefficient was used to analyze the association of depth of response (DpR) with PFS and OS. Serum VEGF-D levels were measured in samples collected before treatment using magnetic bead panel Milliplex xMAP kits.
RESULTS


In total, 101 patients (Pani, n = 49; Bev, n = 52) were enrolled in this study. Patients with ETS had longer PFS (Pani: hazard ratio (HR) 0.40, P = 0.009; Bev: HR 0.078, P = 0.0002) and OS (Pani: HR 0.49, P = 0.044; Bev: HR 0.35, P = 0.048) than patients without ETS. The DpR was moderately correlated with PFS and OS in Pani (rs = 0.75, P < 0.001; rs = 0.60, P < 0.001) and Bev groups (rs = 0.68, P < 0.001; rs = 0.44, P = 0.002). No significant differences were observed in PFS and OS between the two treatment groups even if in left-sided tumors. No significant interaction between VEGF-D levels and treatment was observed in PFS and OS.
CONCLUSIONS


ETS and DpR serve as surrogate markers of PFS and OS in the second-line treatment with FOLFIRI plus targeted agent for mCRC.",2020,"Patients with ETS had longer PFS (Pani: hazard ratio (HR) 0.40, P = 0.009; Bev: HR 0.078, P = 0.0002) and OS (Pani: HR 0.49, P = 0.044; Bev: HR 0.35, P = 0.048) than patients without ETS.","['patients with metastatic colorectal cancer (mCRC', 'patients with KRAS exon 2 wild-type mCRC who were treated with', 'KRAS exon2 Wild-Type Metastatic Colorectal Cancer', '101 patients (Pani, n\u2009=\u200949; Bev, n\u2009=\u200952']","['Panitumumab and Bevacizumab', 'FOLFIRI plus panitumumab (Pani) or bevacizumab (Bev']","['early tumor shrinkage (ETS), tumor location, and VEGF-D with progression-free survival (PFS) and overall survival (OS', 'longer PFS', 'PFS and OS', 'Early Tumor Shrinkage and Depth of Response', 'VEGF-D levels', 'Serum VEGF-D levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0664390', 'cui_str': 'Vascular Endothelial Growth Factor-D'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",101.0,0.0754459,"Patients with ETS had longer PFS (Pani: hazard ratio (HR) 0.40, P = 0.009; Bev: HR 0.078, P = 0.0002) and OS (Pani: HR 0.49, P = 0.044; Bev: HR 0.35, P = 0.048) than patients without ETS.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Izawa', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Kimio', 'Initials': 'K', 'LastName': 'Yonesaka', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sunakawa', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Masuishi', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Department of Gastroenterology, Chiba Cancer Center Hospital, Chiba, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shimonagakubo, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okuda', 'Affiliation': 'Department of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Kondoh', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Kita-Kyushu, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastrointestinal Surgery, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Aizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takako Eguchi', 'Initials': 'TE', 'LastName': 'Nakajima', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan. tnakajima@kuhp.kyoto-u.ac.jp.'}]",Targeted oncology,['10.1007/s11523-020-00750-w']
2507,32962317,"Effect of Water Supplementation on Cognitive Performances and Mood among Male College Students in Cangzhou, China: Study Protocol of a Randomized Controlled Trial.","Introduction : Water accounts for about 75% of brain mass. Cognitive performances and mood may be impaired by hypohydration and improved by water supplementation. Two surveys conducted in China demonstrated that a large proportion of adults and children drank less fluid than the amounts recommended by the Chinese Nutrition Society. The association between hypohydration and cognitive performance has not been reported in China. The purpose of this study is to explore the effect of water supplementation on cognitive performances and mood among male college students in Cangzhou, China.  Methods and Analysis : A randomized controlled trial is designed to test the hypothesis. A total of 68 male college students aged 18-25 years will be recruited and randomly assigned into water-supplementation group (WS group,  n  = 34) and no water-supplementation group (NW group,  n  = 34) after an overnight fasting, i.e., without eating foods and drinking fluid for 12 h. The first morning urine will be collected to determine urine osmolality on the water supplementation day. Cognitive performances and mood will be performed before water supplementation by researchers with questionnaire. Subjects in the WS group will drink 400 mL purified water within 5 min, while those in NW group will not drink any fluid. One hour later, urine will be collected and urine osmolality, cognitive performances and mood will be measured again. Mixed model of repeated measures ANOVA will be used to investigate the effect of water supplementation on cognitive performances. The study would provide information about the benefit of water supplementation on cognitive performances.  Ethics and Dissemination : The study protocol is reviewed and approved by the Ethical Review Committee of the Chinese Nutrition Society. Ethical approval project identification code is CNS-2015-001. Results will be published according to the CONSORT statement and will be reported in peer-reviewed journals.  Trial registration : Chinese clinical trial registry. Identifier: ChiCTR-IOR-15007020. Registry name ""The effect of hydration on cognitive performance"".",2017,Cognitive performances and mood may be impaired by hypohydration and improved by water supplementation.,"['Male College Students in Cangzhou, China', '68 male college students aged 18-25 years', 'male college students in Cangzhou, China']","['Water Supplementation', 'water-supplementation group (WS group,  n  = 34) and no water-supplementation group (NW group,  n  = 34) after an overnight fasting, i.e., without eating foods and drinking fluid for 12 h', 'water supplementation']","['cognitive performances and mood', 'cognitive performances', 'Cognitive Performances and Mood']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}]",68.0,0.121658,Cognitive performances and mood may be impaired by hypohydration and improved by water supplementation.,"[{'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University; 38 Xue Yuan Road, Hai Dian District, Beijing 100191, China.'}, {'ForeName': 'Songming', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Chinese Nutrition Society; 6 Guang An Men Nei Street, Xi Cheng District, Beijing 100053, China.'}, {'ForeName': 'Zhenchuang', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture; 12 Zhong Guan Cun Nan Street, Hai Dian District, Beijing 100081, China.'}, {'ForeName': 'Mengqi', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention; 29 Nan Wei Road, Xi Chen District, Beijing 100050, China.'}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University; 38 Xue Yuan Road, Hai Dian District, Beijing 100191, China.'}]",International journal of environmental research and public health,['10.3390/ijerph14090966']
2508,32962406,The effect of pituitary adenylate cyclase-activating peptide-38 and vasoactive intestinal peptide in cluster headache.,"BACKGROUND


Previously reported increases in serum levels of vasodilating neuropeptides pituitary adenylate cyclase-activating peptide-38 (PACAP38) and vasoactive intestinal peptide (VIP) during attacks of cluster headache could indicate their involvement in cluster headache attack initiation. We investigated the attack-inducing effects of PACAP38 and vasoactive intestinal peptide in cluster headache, hypothesising that PACAP38, but not vasoactive intestinal peptide, would induce cluster-like attacks in episodic active phase and chronic cluster headache patients.
METHODS


In a double-blind crossover study, 14 episodic cluster headache patients in active phase, 15 episodic cluster headache patients in remission phase and 15 chronic cluster headache patients were randomly allocated to receive intravenous infusion of PACAP38 (10 pmol/kg/min) or vasoactive intestinal peptide (8 pmol/kg/min) over 20 min on two study days separated by at least 7 days. We recorded headache intensity, incidence of cluster-like attacks, cranial autonomic symptoms and vital signs using a questionnaire (0-90 min).
RESULTS


In episodic cluster headache active phase, PACAP38 induced cluster-like attacks in 6/14 patients and vasoactive intestinal peptide induced cluster-like attacks in 5/14 patients ( p  = 1.000). In chronic cluster headache, PACAP38 and vasoactive intestinal peptide both induced cluster-like attacks in 7/15 patients ( p  = 0.765). In episodic cluster headache remission phase, neither PACAP38 nor vasoactive intestinal peptide induced cluster-like attacks.
CONCLUSIONS


Contrary to our hypothesis, attack induction was lower than expected and roughly equal by PACAP38 and vasoactive intestinal peptide in episodic active phase and chronic cluster headache patients, which contradicts the PAC 1 -receptor as being solely responsible for attack induction. Trial registration:  clinicaltrials.gov (identifier NCT03814226).",2020,"Contrary to our hypothesis, attack induction was lower than expected and roughly equal by PACAP38 and vasoactive intestinal peptide in episodic active phase and chronic cluster headache patients, which contradicts the PAC 1 -receptor as being solely responsible for attack induction.","['14 episodic cluster headache patients in active phase, 15 episodic cluster headache patients in remission phase and 15 chronic cluster headache patients', 'cluster headache']","['PACAP38 and vasoactive intestinal peptide', 'vasoactive intestinal peptide', 'intravenous infusion of PACAP38', 'pituitary adenylate cyclase-activating peptide-38 and vasoactive intestinal peptide']","['headache intensity, incidence of cluster-like attacks, cranial autonomic symptoms and vital signs using a questionnaire (0-90\u2009min']","[{'cui': 'C0393739', 'cui_str': 'Episodic cluster headache'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}]","[{'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001492', 'cui_str': 'Adenylate cyclase'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0042395', 'cui_str': 'vasoactive intestinal peptide'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439232', 'cui_str': 'min'}]",14.0,0.083924,"Contrary to our hypothesis, attack induction was lower than expected and roughly equal by PACAP38 and vasoactive intestinal peptide in episodic active phase and chronic cluster headache patients, which contradicts the PAC 1 -receptor as being solely responsible for attack induction.","[{'ForeName': 'Anne Luise H', 'Initials': 'ALH', 'LastName': 'Vollesen', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Snoer', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Basit', 'Initials': 'B', 'LastName': 'Chaudhry', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anja Sofie', 'Initials': 'AS', 'LastName': 'Petersen', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hagedorn', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoffmann', 'Affiliation': ""Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Rigmor H', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420940689']
2509,32962422,The effect of transcranial pulsed current stimulation at 4 and 75 Hz on EEG theta and high gamma band power: A pilot study.,"Transcranial pulsed current stimulation (tPCS) is an emerging non-invasive brain stimulation technique that has shown significant effects on cortical excitability. To date, electrophysiological measures of the efficiency of monophasic tPCS have not been reported. Therefore, we explored the effects of monophasic anodal and cathodal-tPCS (a-tPCS/c-tPCS) at theta (4 Hz) and gamma (75 Hz) frequencies on theta and high gamma electroencephalography (EEG) oscillatory power. In a single-blind randomized sham-controlled cross-over design, 15 healthy participants were randomly assigned into five experimental sessions in which they received a-PCS/c-tPCS at 4 and 75 Hz or sham stimulation over the left primary motor cortex (M1) for 15 min at an intensity of 1.5 mA. Changes in theta and high gamma oscillatory power were recorded at baseline, immediately after, and 30 minutes after stimulation using EEG at rest with eyes open. A-tPCS at 4 Hz showed a significant increase in theta power compared to sham, whereas c-tPCS at 4 Hz had no significant effect on theta power. A-tPCS at 75 Hz produced no changes in high gamma power compared to sham. Importantly, c-tPCS at 75 Hz led to a significant reduction in high gamma power compared to baseline, as well as compared to c-tPCS at 4 Hz and sham stimulation. The results demonstrate the modulation of oscillatory brain activity by monophasic tPCS, and highlight the need for future studies on a larger scale to confirm these initial findings.",2020,"A-tPCS at 4 Hz showed a significant increase in theta power compared to sham, whereas c-tPCS at 4 Hz had no significant effect on theta power.",['15 healthy participants'],"['Transcranial pulsed current stimulation (tPCS', 'PCS/c-tPCS at 4 and 75 Hz or sham stimulation over the left primary motor cortex (M1', 'transcranial pulsed current stimulation at 4 and 75 Hz on EEG theta and high gamma band power', 'monophasic anodal and cathodal-tPCS (a-tPCS/c-tPCS) at theta (4 Hz) and gamma (75 Hz) frequencies on theta and high gamma electroencephalography (EEG) oscillatory power']",['theta power'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0205186', 'cui_str': 'Monophasic'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}]",15.0,0.0508888,"A-tPCS at 4 Hz showed a significant increase in theta power compared to sham, whereas c-tPCS at 4 Hz had no significant effect on theta power.","[{'ForeName': 'Thusharika', 'Initials': 'T', 'LastName': 'Dissanayaka', 'Affiliation': 'Monash University, 2541, 6/63, Frankston-flinders road, Frankston, Frankston, Victoria, Australia, 3199; thusharika.dissanayaka@monash.edu.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zoghi', 'Affiliation': 'La Trobe University, 2080, Melbourne, Victoria, Australia; m.zoghi@latrobe.edu.au.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Melbourne, Australia; aron.hill@monash.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': 'Melbourne, Australia; michael.j.farrell@monash.edu.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Egan', 'Affiliation': 'Monash University, Monash Biomedical Imaging; School of Psychological Sciences, Melbourne, Victoria, Australia.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Monash University, 2541, Clayton, Victoria, Australia; shapour.jaberzadeh@monash.edu.'}]",Brain connectivity,['10.1089/brain.2020.0756']
2510,32962443,Evaluation of cardiovascular and renal outcomes with ertugliflozin: what is the VERdict from the VERTIS-CV trial?,"INTRODUCTION


A growing number of antidiabetic agents have demonstrated cardiovascular and renal benefits in cardiovascular outcome trials (CVOTs), despite such trials being principally required to rule out excess cardiovascular risk.
AREAS COVERED


This article addresses the Evaluation of Ertugliflozin Efficacy and Safety Cardiovascular Outcomes (VERTIS-CV) trial, its background, design, results, and implications. In patients at least 40 years of age with atherosclerotic cardiovascular disease (ASCVD), the VERTIS-CV trial demonstrated ertugliflozin was non-inferior to placebo for major adverse cardiovascular events, though not superior. Ertugliflozin significantly reduced hospitalization for heart failure compared to placebo. The composite renal outcome was not significantly different between groups. Ertugliflozin was generally well tolerated with a safety profile commensurate with other sodium-glucose co-transporter-2 inhibitors (SGLT-2) inhibitors.
EXPERT OPINION


In patients with type 2 diabetes and ASCVD, ertugliflozin appears safe with a noted non-significant trend toward improved renal outcomes. Approximately 23.7% of patients in the VERTIS-CV trial had heart failure, the highest among SGLT-2 inhibitor CVOTs. The VERTIS-CV trial reaffirms the reduction in heart failure hospitalizations as a likely class effect of SGLT-2 inhibitors. While the trial supports the use of ertugliflozin beyond glycemic control, agents with confirmed superiority for improved cardiovascular outcomes and mortality may be preferred.",2020,The composite renal outcome was not significantly different between groups.,['patients at least 40\xa0years of age with atherosclerotic cardiovascular disease (ASCVD'],"['ertugliflozin', 'Ertugliflozin', 'placebo']","['heart failure hospitalizations', 'hospitalization for heart failure', 'heart failure', 'renal outcomes', 'composite renal outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",,0.116426,The composite renal outcome was not significantly different between groups.,"[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cowart', 'Affiliation': 'Department of Pharmacotherapeutics & Clinical Research, Taneja College of Pharmacy , Tampa, FL, USA.'}, {'ForeName': 'Nicholas W', 'Initials': 'NW', 'LastName': 'Carris', 'Affiliation': 'Department of Pharmacotherapeutics & Clinical Research, Taneja College of Pharmacy , Tampa, FL, USA.'}]",Expert opinion on pharmacotherapy,['10.1080/14656566.2020.1822327']
2511,32962539,Mental Fatigue Reduces Training Volume in Resistance Exercise: A Cross-Over and Randomized Study.,"The present study aimed to determine the effect of mental fatigue (MF) on total training volume (TTV; number of repetitions x number of sets x load) and on ratings of perceived exertion (RPE; Borg, 1982) in the half-back squat exercise (HBSE). Nine male subjects ( M  age = 22.6 years,  SD =   2.3;  M  height = 172.3 cm , SD =   6.8;  M  weight = 76.2 kg , SD =   9.8;  M  years of resistance training experience = 4.1,  SD  = 2.3 years) recruited from a university population were study participants in this participant-blind cross-over and randomized study. Participants underwent either the Stroop task - a highly demanding cognitive task (CT) - or a control condition (CON) in which they viewed a documentary exhibition for 30 minutes. Perception of MF and motivation were assessed after treatments using a visual analog scale of 100 mm. Participants then engaged in a countermovement jump (CMJ) test and three sets of HBSE until they reached momentary concentric failure, reporting RPE at the end of each exercise set. Following the CT, participants showed a significantly increased self-perception of MF in relation to the CON condition ( p  = 0.01;  d  = 1.2), but this did not affect their motivation to engage in subsequent tests ( p  = 0.99;  d  = 0.006). Neither the CMJ performances nor the RPE were statistically different between CT and CON conditions ( p  = 0.33;  d  = 0.09 and  p  = 0.20 ; η 2  = 0.20, respectively). TTV was significantly lower in the CT relative to the CON experimental condition (Δ = -15.8%;  p  = 0.04;  η 2  = 0.48). Prolonged involvement in a CT was associated with reduced volume on a resistance exercise, though this effect was not associated with changes in CMJ performance or motivation to exercise.",2020,"Neither the CMJ performances nor the RPE were statistically different between CT and CON conditions ( p  = 0.33;  d  = 0.09 and  p  = 0.20 ; η 2  = 0.20, respectively).","['Nine male subjects ( M  age\u2009=\u200922.6\u2009years,  SD\u2009=\u2009 \u20092.3;  M  height\u2009=\u2009172.3\u2009cm , SD\u2009=\u2009 \u20096.8;  M  weight\u2009=\u200976.2\u2009kg , SD\u2009=\u2009 \u20099.8;  M  years of resistance training experience\u2009=\u20094.1,  SD \u2009=\u20092.3\u2009years) recruited from a university population were study participants in this participant-blind cross-over and randomized study']","['half-back squat exercise (HBSE', 'Stroop task - a highly demanding cognitive task (CT) - or a control condition (CON', 'mental fatigue (MF']","['motivation to engage in subsequent tests', 'TTV', 'self-perception of MF', 'CMJ performance or motivation to exercise', 'total training volume (TTV; number of repetitions x number of sets x load', 'Perception of MF and motivation', 'CMJ performances nor the RPE']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",9.0,0.0555088,"Neither the CMJ performances nor the RPE were statistically different between CT and CON conditions ( p  = 0.33;  d  = 0.09 and  p  = 0.20 ; η 2  = 0.20, respectively).","[{'ForeName': 'Victor Sabino de', 'Initials': 'VS', 'LastName': 'Queiros', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal-RN, Brazil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Dantas', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal-RN, Brazil.'}, {'ForeName': 'Leonardo de Sousa', 'Initials': 'LS', 'LastName': 'Fortes', 'Affiliation': 'Department of Physical Education, Federal University of Paraíba, João Pessoa-PB, Brazil.'}, {'ForeName': 'Luiz Felipe da', 'Initials': 'LFD', 'LastName': 'Silva', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal-RN, Brazil.'}, {'ForeName': 'Gilson Mendes da', 'Initials': 'GMD', 'LastName': 'Silva', 'Affiliation': 'Department of Physical Education, Maurício de Nassau University Center, Campina Grande-PB, Brazil.'}, {'ForeName': 'Paulo Moreira Silva', 'Initials': 'PMS', 'LastName': 'Dantas', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal-RN, Brazil.'}, {'ForeName': 'Breno Guilherme de Araújo Tinôco', 'Initials': 'BGAT', 'LastName': 'Cabral', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal-RN, Brazil.'}]",Perceptual and motor skills,['10.1177/0031512520958935']
2512,32962569,Effects of osteoblast autophagy on glucocorticoid-induced femoral head necrosis.,"OBJECTIVES


This study aims to explore the mechanism by which osteoblast autophagy participated in glucocorticoid-induced femoral head necrosis (FHN).
MATERIALS AND METHODS


Thirty male specific-pathogen-free C57 mice (age, one month; weighing 20-25 g) were randomly divided into blank control, dexamethasone and rapamycin-dexamethasone groups (n=10). After six weeks of intervention, right femoral head was obtained to observe morphology and to calculate percentage of empty lacunae. MC3T3-E1 cells were randomly divided into normal, dexamethasone, rapamycin and dexamethasone-rapamycin groups, and cultured for 24 h. Microtubule-associated protein 1 light chain 3 (LC3)-I, LC3-II, mammalian target of rapamycin (mTOR) and Beclin-1 protein expressions were detected by Western blot.
RESULTS


In rapamycin-dexamethasone group, some bone trabeculae in medullary cavity ruptured and atrophied, and subchondral bone underwent local necrosis. The total apoptosis rates of dexamethasone and rapamycin-dexamethasone groups surpassed that of blank control group, and the former two groups had significantly different rates (p<0.001). LC3-II/LC3-I of dexamethasone group was lower than those of rapamycin and dexamethasone-rapamycin groups (p<0.001), and the ratio of rapamycin group surpassed that of dexamethasone-rapamycin group (p<0.001). Dexamethasone group had higher mTOR protein expression than those of rapamycin and dexamethasone- rapamycin groups (p<0.001), and the expression of rapamycin group was lower than that of dexamethasone-rapamycin group (p<0.001). The Beclin-1 protein expression of dexamethasone group was lower than those of rapamycin and dexamethasone- rapamycin groups (p<0.001), and the expression of rapamycin group exceeded that of dexamethasone-rapamycin group (p<0.05).
CONCLUSION


Osteoblast autophagy may play a crucial protective role in dexamethasone-induced FHN. The attenuation of autophagy may be related to the affected expressions of key autophagy regulators mTOR and Beclin-1.",2020,"Dexamethasone group had higher mTOR protein expression than those of rapamycin and dexamethasone- rapamycin groups (p<0.001), and the expression of rapamycin group was lower than that of dexamethasone-rapamycin group (p<0.001).","['Thirty male specific-pathogen-free C57 mice (age, one month; weighing 20-25 g', 'groups (n=10']","['blank control, dexamethasone and rapamycin-dexamethasone', 'dexamethasone and rapamycin-dexamethasone', 'rapamycin and dexamethasone- rapamycin', 'dexamethasone-rapamycin', 'dexamethasone', 'rapamycin and dexamethasone-rapamycin', 'Dexamethasone', 'rapamycin-dexamethasone', 'dexamethasone, rapamycin and dexamethasone-rapamycin groups, and cultured for 24 h. Microtubule-associated protein 1 light chain 3 (LC3)-I, LC3-II, mammalian target of rapamycin (mTOR']","['Beclin-1 protein expression', 'total apoptosis rates', 'mTOR protein expression']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0162470', 'cui_str': 'Specific Pathogen Free'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0026045', 'cui_str': 'Microtubule Associated Proteins'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0293060', 'cui_str': 'FKBP12-Rapamycin Associated Protein'}]","[{'cui': 'C4255099', 'cui_str': 'Beclin-1 Protein'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0293060', 'cui_str': 'FKBP12-Rapamycin Associated Protein'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",30.0,0.0197136,"Dexamethasone group had higher mTOR protein expression than those of rapamycin and dexamethasone- rapamycin groups (p<0.001), and the expression of rapamycin group was lower than that of dexamethasone-rapamycin group (p<0.001).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yaozeng', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopedics, First Affiliated Hospital of Soochow University, Suzhou 215006, Jiangsu Province, People's Republic of China. xuyzfahsu@aliyun.com.""}, {'ForeName': 'Jiannong', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Chenjun', 'Initials': 'C', 'LastName': 'Zhai', 'Affiliation': ''}]",Joint diseases and related surgery,['10.5606/ehc.2020.73036']
2513,32962591,Does mini-midvastus approach have an advantageous effect on rapid recovery protocols over medial parapatellar approach in total knee arthroplasty?,"OBJECTIVES


This study aims to compare the effects of mini-midvastus (MMV) versus medial parapatellar (MPP) approach on rapid recovery protocols during total knee arthroplasty (TKA).
PATIENTS AND METHODS


This prospective, randomized, single-blinded study was performed in 54 patients (4 males, 50 females; mean age 64.1±6.4 years) diagnosed as primary knee osteoarthritis and planned for unilateral TKA between May 2018 and March 2019. Patients were randomly assigned as MMV (1 male, 26 females; mean age 65±6.4 years) and MPP (3 males, 24 females; mean age 63.2±6.3 years) groups. Rapid recovery TKA protocol and discharge criteria were assembled and all patients were evaluated preoperatively, and at postoperative first and third months. Length of hospital stay (LOS) was recorded for all patients. Hemoglobin and hematocrit values, radiologic assessment of alignment, knee range of motion (ROM), quadriceps muscle strength, visual analog scale (VAS), 30-sec chair-stand test, stair-climb test, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), and Short Form-36 (SF-36) were used for evaluations by blinded observers.
RESULTS


There was no significant difference in demographic variables between two groups. Operative time in MMV Group (78.1±2.7 min) was significantly longer than the MPP Group (65.9±2.6 min) (p<0.0005). LOSs in the MMV and MPP Groups were 27.6±3.1 hours and 29.1±6.7 hours with no significant difference. There was no statistically significant difference in postoperative measurements between groups in hemoglobin and hematocrit values, radiologic alignment of components, knee ROM, VAS, 30-sec chair-stand test, stair-climb test, WOMAC, KOOS, and SF-36 evaluations (p>0.05). In terms of quadriceps muscle strength gain, we could not find any difference between groups in pre- and postoperative difference of changes (p>0.05).
CONCLUSION


With the use of contemporary rapid recovery protocols during TKA, MMV approach had no superiority over MPP approach when quadriceps muscle strength, LOS, pain, function, and quality of life were assessed. Longer operative time in the MMV approach compared to MPP approach may be considered as a disadvantage.",2020,"In terms of quadriceps muscle strength gain, we could not find any difference between groups in pre- and postoperative difference of changes (p>0.05).
","['total knee arthroplasty (TKA', '54 patients (4 males, 50 females; mean age 64.1±6.4 years) diagnosed as primary knee osteoarthritis and planned for unilateral TKA between May 2018 and March 2019', '1 male, 26 females; mean age 65±6.4 years) and MPP (3 males, 24 females; mean age 63.2±6.3 years) groups']","['mini-midvastus (MMV) versus medial parapatellar (MPP) approach', 'MPP', 'MMV', 'TKA']","['demographic variables', 'Hemoglobin and hematocrit values, radiologic assessment of alignment, knee range of motion (ROM), quadriceps muscle strength, visual analog scale (VAS), 30-sec chair-stand test, stair-climb test, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), and Short Form-36 (SF-36', 'LOSs', 'Longer operative time', 'quadriceps muscle strength, LOS, pain, function, and quality of life', 'Operative time', 'Rapid recovery TKA protocol and discharge criteria', 'hemoglobin and hematocrit values, radiologic alignment of components, knee ROM, VAS, 30-sec chair-stand test, stair-climb test, WOMAC, KOOS, and SF-36 evaluations (p>0.05', 'Length of hospital stay (LOS', 'postoperative measurements']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0442141', 'cui_str': 'Medial parapatellar approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0442141', 'cui_str': 'Medial parapatellar approach'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",54.0,0.0968514,"In terms of quadriceps muscle strength gain, we could not find any difference between groups in pre- and postoperative difference of changes (p>0.05).
","[{'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Zora', 'Affiliation': ''}, {'ForeName': 'Harun R', 'Initials': 'HR', 'LastName': 'Güngör', 'Affiliation': 'Pamukkale Üniversitesi Tıp Fakültesi Ortopedi ve Travmatoloji Anabilim Dalı, 20070 Pamukkale, Denizli, Türkiye. hrgungor@gmail.com.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Bayrak', 'Affiliation': ''}, {'ForeName': 'Raziye', 'Initials': 'R', 'LastName': 'Şavkın', 'Affiliation': ''}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Büker', 'Affiliation': ''}]",Joint diseases and related surgery,['10.5606/ehc.2020.76387']
2514,32962593,Effects of intraarticular ketamine combined with periarticular bupivacaine on postoperative pain after arthroscopic meniscectomy.,"OBJECTIVES


This study aims to evaluate the effects of two different doses of intraarticular ketamine on visual analog scale (VAS) scores at rest and movement, time to first analgesic requirement, and 24-h morphine consumption in patients undergoing arthroscopic meniscectomy as well as to assess the frequency of postoperative nausea&vomiting, respiratory depression, pruritus, urinary retention, and constipation and to compare the time to discharge.
PATIENTS AND METHODS


This prospective randomized double-blind study was performed between August 2013 and August 2014 on 75 patients (32 males, 43 females; mean age 46.7±13 years; range, 18 to 75 years) with American Society of Anesthesiologists scores of I-II scheduled for unilateral meniscectomy. Patients were randomized to receive 0.5 mg.kg -1  ketamine (group K1), 1 mg.kg -1  ketamine (group K2) or saline (group S) to a total volume of 20 mL intraarticularly at the end of the surgery. All patients were performed periarticular 10 mL 0.5% bupivacaine infiltration. Visual analog scale at rest and during passive knee movement was used to evaluate pain both preoperatively and at postoperative 0, 30 min, and 1, 2, 4, 6, 12, and 24 h. Time to first analgesic requirement and morphine consumption were recorded.
RESULTS


Visual analog scale scores at rest and during movement at postoperative 0 were significantly reduced in group K2 compared with group S (p<0.05). The first analgesic requirement time was significantly longer in group K1 (76.9±25.2 min) and group K2 (93.4±26.1 min) than group S (29.3±7.1 min). Morphine consumption was lower in group K2 compared to group K1 and group S at postoperative 30 min, and 1 and 2 h. However, 24-h morphine consumption was similar in all groups.
CONCLUSION


Intraarticular injection of 0.5 mg.kg -1  and 1 mg.kg -1  ketamine for postoperative pain management provided similar analgesic efficacy. However, high dose ketamine more noticeably decreased opioid requirement in the early postoperative period.",2020,"Morphine consumption was lower in group K2 compared to group K1 and group S at postoperative 30 min, and 1 and 2 h.","['August 2013 and August 2014 on 75 patients (32 males, 43 females; mean age 46.7±13 years; range, 18 to 75 years) with American Society of Anesthesiologists scores of I-II scheduled for unilateral meniscectomy', 'patients undergoing arthroscopic meniscectomy', 'after arthroscopic meniscectomy']","['bupivacaine', 'ketamine (group K2) or saline', 'ketamine', 'intraarticular ketamine combined with periarticular bupivacaine', 'intraarticular ketamine']","['Visual analog scale scores', 'opioid requirement', 'visual analog scale (VAS) scores at rest and movement, time to first analgesic requirement, and 24-h morphine consumption', 'analgesic requirement time', 'analgesic efficacy', 'Visual analog scale', 'Morphine consumption', '24-h morphine consumption', 'postoperative pain', 'frequency of postoperative nausea&vomiting, respiratory depression, pruritus, urinary retention, and constipation and to compare the time to discharge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0187901', 'cui_str': 'Chondrectomy of semilunar cartilage of knee'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0814667,"Morphine consumption was lower in group K2 compared to group K1 and group S at postoperative 30 min, and 1 and 2 h.","[{'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Sağır', 'Affiliation': 'Balıkesir Üniversitesi Tıp Fakültesi Anesteziyoloji ve Reanimasyon Anabilim Dalı, 10145 Bigadiç, Balıkesir, Türkiye. ozlemsagir@yahoo.com.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Tatar', 'Affiliation': ''}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Ugün', 'Affiliation': ''}, {'ForeName': 'Hafize Fisun', 'Initials': 'HF', 'LastName': 'Demir', 'Affiliation': ''}, {'ForeName': 'Ayşe Neslihan', 'Initials': 'AN', 'LastName': 'Balkaya', 'Affiliation': ''}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Meriç', 'Affiliation': ''}, {'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Kocaoğlu', 'Affiliation': ''}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Köroğlu', 'Affiliation': ''}]",Joint diseases and related surgery,['10.5606/ehc.2020.75274']
2515,32962685,Scaled-up nutrition education on pulse-cereal complementary food practice in Ethiopia: a cluster-randomized trial.,"BACKGROUND


Improving children's weight status through nutrition education (NE) for mothers about using pulses in complementary feeding has been demonstrated in pilot studies, but no effect on stunting was reported. The aim of the study was to assess the impact of a 9-month pulse-nutrition education program on improving mothers' knowledge, attitude, and practices (KAP) towards pulses, as well as its effect on children's diet diversity, and nutritional status. The NE was delivered by Health Extension Workers (HEWs).
METHODS


A cluster randomized study was employed for the community-based interventional study. Twelve randomly selected villages in Sidama Zone, Southern Ethiopia were included in the study. A total of 772 mother-child pairs involved in the study; where 386 mother-child pairs in the intervention group received additional messages about pulse-cereal complementary food, and 386 pairs (the control) received only routine health education for 9 months. A survey on mothers' KAP and anthropometric measurements of the children were taken at baseline, midpoint, and end point. ANOVA and descriptive statistics were used to analyzed data.
RESULTS


At baseline and end point, maternal KAP and the dietary diversity score of the children (mean age at end point 18.8 ± 2.9 mo) were assessed. Intervention mothers' KAP improved (p < 0.001) at midpoint and end point compared to that of the control group, as did frequency of pulse consumption and Dietary Diversity Score (DDS) among children. At 9 months, the prevalence of stunting, wasting, and underweight was significantly reduced in the intervention group compared to the control group (p = 0.001).
CONCLUSIONS


NE delivered by HEWs improved KAP of mothers regarding pulse consumption and dietary diversity of children led to improved nutritional status of the children. Training HEWs on the use of pulses for complementary food may be an effective way to improve the health of children in Ethiopian communities.
TRIAL REGISTRATION


Clinicaltrials.gov # NCT02638571 . Date of registration: 12/18/2015. Prospectively registered.",2020,"At 9 months, the prevalence of stunting, wasting, and underweight was significantly reduced in the intervention group compared to the control group (p = 0.001).
","['772 mother-child pairs involved in the study; where 386 mother-child pairs in the intervention group received', 'Twelve randomly selected villages in Sidama Zone, Southern Ethiopia were included in the study']","['additional messages about pulse-cereal complementary food, and 386 pairs (the control) received only routine health education', 'pulse-nutrition education program', 'nutrition education (NE']","[""mothers' knowledge, attitude, and practices (KAP"", 'prevalence of stunting, wasting, and underweight', 'pulse consumption and Dietary Diversity Score (DDS', 'maternal KAP and the dietary diversity score']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",12.0,0.0630381,"At 9 months, the prevalence of stunting, wasting, and underweight was significantly reduced in the intervention group compared to the control group (p = 0.001).
","[{'ForeName': 'Getenesh Berhanu', 'Initials': 'GB', 'LastName': 'Teshome', 'Affiliation': 'School of Nutrition, Food Science and Technology, Hawassa University, Hawassa, Ethiopia. getemimib@gmail.com.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Whiting', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Green', 'Affiliation': 'SAHMRI, Australia, Adelaide, Australia.'}, {'ForeName': 'Demmelash', 'Initials': 'D', 'LastName': 'Mulualem', 'Affiliation': 'School of Nutrition, Food Science and Technology, Hawassa University, Hawassa, Ethiopia.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada.'}]",BMC public health,['10.1186/s12889-020-09262-8']
2516,32960514,Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment.,"BACKGROUND


It is thought that a reduction in the frequency of basal insulin injections might facilitate treatment acceptance and adherence among patients with type 2 diabetes. Insulin icodec is a basal insulin analogue designed for once-weekly administration that is in development for the treatment of diabetes.
METHODS


We conducted a 26-week, randomized, double-blind, double-dummy, phase 2 trial to investigate the efficacy and safety of once-weekly insulin icodec as compared with once-daily insulin glargine U100 in patients who had not previously received long-term insulin treatment and whose type 2 diabetes was inadequately controlled (glycated hemoglobin level, 7.0 to 9.5%) while taking metformin with or without a dipeptidyl peptidase 4 inhibitor. The primary end point was the change in glycated hemoglobin level from baseline to week 26. Safety end points, including episodes of hypoglycemia and insulin-related adverse events, were also evaluated.
RESULTS


A total of 247 participants were randomly assigned (1:1) to receive icodec or glargine. Baseline characteristics were similar in the two groups; the mean baseline glycated hemoglobin level was 8.09% in the icodec group and 7.96% in the glargine group. The estimated mean change from baseline in the glycated hemoglobin level was -1.33 percentage points in the icodec group and -1.15 percentage points in the glargine group, to estimated means of 6.69% and 6.87%, respectively, at week 26; the estimated between-group difference in the change from baseline was -0.18 percentage points (95% CI, -0.38 to 0.02, P = 0.08). The observed rates of hypoglycemia with severity of level 2 (blood glucose level, <54 mg per deciliter) or level 3 (severe cognitive impairment) were low (icodec group, 0.53 events per patient-year; glargine group, 0.46 events per patient-year; estimated rate ratio, 1.09; 95% CI, 0.45 to 2.65). There was no between-group difference in insulin-related key adverse events, and rates of hypersensitivity and injection-site reactions were low. Most adverse events were mild, and no serious events were deemed to be related to the trial medications.
CONCLUSIONS


Once-weekly treatment with insulin icodec had glucose-lowering efficacy and a safety profile similar to those of once-daily insulin glargine U100 in patients with type 2 diabetes. (Funded by Novo Nordisk; NN1436-4383 ClinicalTrials.gov number, NCT03751657.).",2020,"There was no between-group difference in insulin-related key adverse events, and rates of hypersensitivity and injection-site reactions were low.","['patients with type 2 diabetes', 'patients who had not previously received long-term insulin treatment and whose type 2 diabetes was inadequately controlled (glycated hemoglobin level, 7.0 to 9.5%) while taking metformin with or without a dipeptidyl peptidase 4 inhibitor', 'A total of 247 participants']","['icodec or glargine', 'glargine']","['glycated hemoglobin level', 'efficacy and safety', 'episodes of hypoglycemia and insulin-related adverse events', 'level 3 (severe cognitive impairment', 'mean baseline glycated hemoglobin level', 'rates of hypoglycemia with severity of level 2 (blood glucose level', 'insulin-related key adverse events, and rates of hypersensitivity and injection-site reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}]",247.0,0.321802,"There was no between-group difference in insulin-related key adverse events, and rates of hypersensitivity and injection-site reactions were low.","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Janež', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silver', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Begtrup', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Hansen', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Jia', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Goldenberg', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2022474']
2517,30778821,Network Analysis of Behaviors in the Depression and Autism Realms: Inter-Relationships and Clinical Implications.,"Depression-, anxiety-, OCD- and autism-related behaviors were assessed in 118 high-functioning individuals with autism spectrum disorders (ASD) and in 2016 controls. The ASD group had a higher rate of clinical depression and markedly higher ""insomnia"" and ""restlessness"" scores. Network analysis and hierarchical cluster analysis in the ASD group revealed that depression and anxiety items clustered together, but separately from autism-related items. Compared to controls, ""insomnia"" and ""restlessness"" items in the ASD network of depression items were much more central (higher closeness, and betweenness centrality). Combined networks of depression-, anxiety-, and OCD-related items revealed that the control group depression item module was not preserved in ASD. The results indicate that depression is atypical in autism and suggest specific intervention targets.",2020,"Network analysis and hierarchical cluster analysis in the ASD group revealed that depression and anxiety items clustered together, but separately from autism-related items.",['118 high-functioning individuals with autism spectrum disorders (ASD) and in 2016 controls'],[],"['rate of clinical depression', 'Depression-, anxiety-, OCD- and autism-related behaviors', 'insomnia"" and ""restlessness"" scores']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",118.0,0.0308178,"Network analysis and hierarchical cluster analysis in the ASD group revealed that depression and anxiety items clustered together, but separately from autism-related items.","[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Montazeri', 'Affiliation': 'Child Study Center, Yale University School of Medicine, 230 S. Frontage Rd, New Haven, CT, 06519, USA. farhad.montazeri-lemraski@yale.edu.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'de Bildt', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Department of Psychiatry, University of Groningen, University of Groningen Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Dekker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Department of Psychiatry, University of Groningen, University of Groningen Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Anderson', 'Affiliation': 'Child Study Center, Yale University School of Medicine, 230 S. Frontage Rd, New Haven, CT, 06519, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03914-4']
2518,30814561,The Effect of Visual Capture Towards Subjective Embodiment Within the Full Body Illusion.,"Typically, multisensory illusion paradigms emphasise the importance of synchronous visuotactile integration to induce subjective embodiment towards another body. However, the extent to which embodiment is due to the 'visual capture' of congruent visuoproprioceptive information alone remains unclear. Thus, across two experiments (total N = 80), we investigated how mere visual observation of a mannequin body, viewed from a first-person perspective, influenced subjective embodiment independently from concomitant visuotactile integration. Moreover, we investigated whether slow, affective touch on participants' own, unseen body (without concomitant touch on the seen mannequin) disrupted visual capture effects to a greater degree than fast, non-affective touch. In total, 40% of participants experienced subjective embodiment towards the mannequin body following mere visual observation, and this effect was significantly higher than conditions which included touch to participants own, unseen body. The velocity of the touch that participants received (affective/non-affective) did not differ in modulating visual capture effects. Furthermore, the effects of visual capture and perceived pleasantness of touch was not modulated by subthreshold eating disorder psychopathology. Overall, this study suggests that congruent visuoproprioceptive cues can be sufficient to induce subjective embodiment of a whole body, in the absence of visuotactile integration and beyond mere confabulatory responses.",2019,The velocity of the touch that participants received (affective/non-affective) did not differ in modulating visual capture effects.,[],['Visual Capture'],['visual capture effects'],[],"[{'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0357221,The velocity of the touch that participants received (affective/non-affective) did not differ in modulating visual capture effects.,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Carey', 'Affiliation': 'Department of Psychology, University of York, York, United Kingdom. mac541@york.ac.uk.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Crucianelli', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Preston', 'Affiliation': 'Department of Psychology, University of York, York, United Kingdom.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Fotopoulou', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}]",Scientific reports,['10.1038/s41598-019-39168-4']
2519,30883859,Emulating a trial of joint dynamic strategies: An application to monitoring and treatment of HIV-positive individuals.,"Decisions about when to start or switch a therapy often depend on the frequency with which individuals are monitored or tested. For example, the optimal time to switch antiretroviral therapy depends on the frequency with which HIV-positive individuals have HIV RNA measured. This paper describes an approach to use observational data for the comparison of joint monitoring and treatment strategies and applies the method to a clinically relevant question in HIV research: when can monitoring frequency be decreased and when should individuals switch from a first-line treatment regimen to a new regimen? We outline the target trial that would compare the dynamic strategies of interest and then describe how to emulate it using data from HIV-positive individuals included in the HIV-CAUSAL Collaboration and the Centers for AIDS Research Network of Integrated Clinical Systems. When, as in our example, few individuals follow the dynamic strategies of interest over long periods of follow-up, we describe how to leverage an additional assumption: no direct effect of monitoring on the outcome of interest. We compare our results with and without the ""no direct effect"" assumption. We found little differences on survival and AIDS-free survival between strategies where monitoring frequency was decreased at a CD4 threshold of 350 cells/μl compared with 500 cells/μl and where treatment was switched at an HIV-RNA threshold of 1000 copies/ml compared with 200 copies/ml. The ""no direct effect"" assumption resulted in efficiency improvements for the risk difference estimates ranging from an 7- to 53-fold increase in the effective sample size.",2019,We found little differences on survival and AIDS-free survival between strategies where monitoring frequency was decreased at a CD4 threshold of 350 cells/μl compared with 500 cells/μl and where treatment was switched at an HIV-RNA threshold of 1000 copies/ml compared with 200 copies/ml.,['HIV-positive individuals'],[],['survival and AIDS-free survival'],"[{'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0565284,We found little differences on survival and AIDS-free survival between strategies where monitoring frequency was decreased at a CD4 threshold of 350 cells/μl compared with 500 cells/μl and where treatment was switched at an HIV-RNA threshold of 1000 copies/ml compared with 200 copies/ml.,"[{'ForeName': 'Ellen C', 'Initials': 'EC', 'LastName': 'Caniglia', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Robins', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Cain', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sabin', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Logan', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Abgrall', 'Affiliation': 'APHP Hôpital Avicenne, Bobigny, France.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Hernández-Díaz', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'Inserm, Université Paris Sud, Orsay, France.'}, {'ForeName': 'Remonie', 'Initials': 'R', 'LastName': 'Seng', 'Affiliation': 'Inserm, Université Paris Sud, Orsay, France.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Drozd', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Seage Iii', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Bonnet', 'Affiliation': 'Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Le Marec', 'Affiliation': 'Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Moore', 'Affiliation': 'School of Medicine, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reiss', 'Affiliation': 'Academisch Medisch Centrum Geneeskunde, Amsterdam, The Netherlands.'}, {'ForeName': 'Ard', 'Initials': 'A', 'LastName': 'van Sighem', 'Affiliation': 'Academisch Medisch Centrum Geneeskunde, Amsterdam, The Netherlands.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Mathews', 'Affiliation': 'Department of Medicine, University of California San Diego Health, San Diego, California.'}, {'ForeName': 'Inma', 'Initials': 'I', 'LastName': 'Jarrín', 'Affiliation': 'National Center of Epidemiology, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Alejos', 'Affiliation': 'National Center of Epidemiology, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Deeks', 'Affiliation': 'School of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Muga', 'Affiliation': 'Germans Trias Hospital, Barcelona, Spain.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Boswell', 'Affiliation': 'Fenway Health, Boston, Massachusetts.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ferrer', 'Affiliation': 'Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': 'Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': 'Southern Alberta HIV Program, Calgary, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pacheco', 'Affiliation': 'Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Napravnik', 'Affiliation': 'Department of Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jose', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Phillips', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Justice', 'Affiliation': 'School of Public Health, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Tate', 'Affiliation': 'School of Public Health, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Heiner C', 'Initials': 'HC', 'LastName': 'Bucher', 'Affiliation': 'Universitätsspital Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Egger', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Hansjakob', 'Initials': 'H', 'LastName': 'Furrer', 'Affiliation': 'Division of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Miro', 'Affiliation': 'University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casabona', 'Affiliation': ""Institut Català d'Oncologia, Barcelona, Spain.""}, {'ForeName': 'Kholoud', 'Initials': 'K', 'LastName': 'Porter', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Giota', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'Department of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, Athens, Greece.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Crane', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Costagliola', 'Affiliation': 'University Pierre and Marie Curie, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Saag', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}]",Statistics in medicine,['10.1002/sim.8120']
2520,30955869,Epitope load identifies kidney transplant recipients at risk of allosensitization following minimization of immunosuppression.,"Human leukocyte antigen (HLA) mismatching and minimization of immunosuppression are two major risk factors for the development of de novo donor-specific antibodies, which are associated with reduced kidney graft survival. Antibodies do not recognize whole HLA antigens but rather individual epitopes, which are short sequences of amino acids in accessible positions. However, compatibility is still assessed by the simple count of mismatched HLA antigens. We hypothesized that the number of mismatched epitopes, or (""epitope load"") would identify patients at the highest risk of developing donor specific antibodies following minimization of immunosuppression. We determined epitope load in 89 clinical trial participants who converted from cyclosporine to everolimus 3 months after kidney transplantation. Twenty-nine participants (32.6%) developed de novo donor specific antibodies. Compared to the number of HLA mismatches, epitope load was more strongly associated with the development of donor specific antibodies. Participants with an epitope load greater than 27 had a 12-fold relative risk of developing donor-specific antibodies compared to those with an epitope load below that threshold. Using that threshold, epitope load would have missed only one participant who subsequently developed donor specific antibodies, compared to 8 missed cases based on a 6-antigen mismatch. DQ7 was the most frequent antigenic target of donor specific antibodies in our population, and some DQ7 epitopes appeared to be more frequently involved than others. Assessing epitope load before minimizing immunosuppression may be a more efficient tool to identify patients at the highest risk of allosensitization.",2019,Participants with an epitope load greater than 27 had a 12-fold relative risk of developing donor-specific antibodies compared to those with an epitope load below that threshold.,"['kidney transplant recipients at risk of allosensitization following minimization of immunosuppression', '89 clinical trial participants who converted from cyclosporine to everolimus 3 months after kidney transplantation', 'Participants with an epitope load greater than 27 had a']",['Human leukocyte antigen (HLA'],"['12-fold relative risk of developing donor-specific antibodies', 'de novo donor specific antibodies', 'kidney graft survival']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C3839712', 'cui_str': 'Allosensitization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003316', 'cui_str': 'Epitope'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}]","[{'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}]",29.0,0.0268037,Participants with an epitope load greater than 27 had a 12-fold relative risk of developing donor-specific antibodies compared to those with an epitope load below that threshold.,"[{'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Snanoudj', 'Affiliation': 'Service de Néphrologie, Hémodialyse et Transplantation Rénale, Hôpital Foch, Suresnes, France; CESP, INSERM, Université Paris-Sud, UVSQ, Université Paris-Saclay, Villejuif, France. Electronic address: r.snanoudj@hopital-foch.com.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': ""Service de Néphrologie et Transplantation d'organe, CHU Rangueil, Toulouse, France.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Cassuto', 'Affiliation': 'Service de Néphrologie, Hôpital Pasteur, CHU de Nice, Nice, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Caillard', 'Affiliation': 'Service de Néphrologie et Transplantation, CHU de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Metzger', 'Affiliation': 'CESP, INSERM, Université Paris-Sud, UVSQ, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Merville', 'Affiliation': 'Service de Néphrologie et Transplantation, Hôpital Pellegrin, Bordeaux, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thierry', 'Affiliation': 'Service de Néphrologie et Transplantation, CHU de Poitiers, Poitiers, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Jollet', 'Affiliation': 'Laboratoire HLA, EFS de Poitiers, Poitiers, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grimbert', 'Affiliation': 'Service de Néphrologie et Transplantation, Hôpital Henri Mondor, Créteil, France.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Anglicheau', 'Affiliation': 'Service de Transplantation et Néphrologie, Hôpital Necker, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hazzan', 'Affiliation': 'Service de Néphrologie, Hôpital Claude Huriez, CHRU de Lille, Lille, France.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Choukroun', 'Affiliation': 'Service de Néphrologie, CHU Amiens-Picardie, Amiens, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Hurault De Ligny', 'Affiliation': 'Service de Néphrologie et Transplantation, CHU de Caen, Caen, France.'}, {'ForeName': 'Bénedicte', 'Initials': 'B', 'LastName': 'Janbon', 'Affiliation': 'Service de Néphrologie et Transplantation, CHU de Grenoble, Grenoble, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vuiblet', 'Affiliation': 'Service de Néphrologie, Hôpital Maison Blanche, Reims, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Devys', 'Affiliation': 'Etablissement français du sang - Centre Pays de Loire, Angers, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Le Meur', 'Affiliation': 'Service de Néphrologie, CHU de Brest, Brest, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Delahousse', 'Affiliation': 'Service de Néphrologie, Hémodialyse et Transplantation Rénale, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Morelon', 'Affiliation': 'Service de Transplantation, Néphrologie et Immunologie Clinique, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Bailly', 'Affiliation': 'Service de Néphrologie, Hôpital Bretonneau, CHU de Tours, Tours, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Girerd', 'Affiliation': 'Service de Néphrologie, CHU Nancy Brabois, Nancy, France.'}, {'ForeName': 'Kahina', 'Initials': 'K', 'LastName': 'Amokrane', 'Affiliation': ""Laboratoire d'Immunologie et Histocompatibilité Hôpital Saint-Louis, Paris, France; INSERM UMRs 1160, Institut Universitaire d'Hématologie, Université Paris Diderot, Paris, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Legendre', 'Affiliation': 'Service de Transplantation et Néphrologie, Hôpital Necker, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Hertig', 'Affiliation': 'Service de Néphrologie et Transplantation, Hôpital Tenon, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rondeau', 'Affiliation': 'Service de Néphrologie et Transplantation, Hôpital Tenon, Paris, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Taupin', 'Affiliation': ""Laboratoire d'Immunologie et Histocompatibilité Hôpital Saint-Louis, Paris, France; INSERM UMRs 1160, Institut Universitaire d'Hématologie, Université Paris Diderot, Paris, France.""}]",Kidney international,['10.1016/j.kint.2018.12.029']
2521,31005271,Cost-effectiveness of lipid lowering with statins and ezetimibe in chronic kidney disease.,"Statin-based treatments reduce cardiovascular disease (CVD) risk in patients with non-dialysis chronic kidney disease (CKD), but it is unclear which regimen is the most cost-effective. We used the Study of Heart and Renal Protection (SHARP) CKD-CVD policy model to evaluate the effect of statins and ezetimibe on quality-adjusted life years (QALYs) and health care costs in the United States (US) and the United Kingdom (UK). Net costs below $100,000/QALY (US) or £20,000/QALY (UK) were considered cost-effective. We investigated statin regimens with or without ezetimibe 10 mg. Treatment effects on cardiovascular risk were estimated per 1-mmol/L reduction in low-density lipoprotein (LDL) cholesterol as reported in the Cholesterol Treatment Trialists' Collaboration meta-analysis, and reductions in LDL cholesterol were estimated for each statin/ezetimibe regimen. In the US, atorvastatin 40 mg ($0.103/day as of January 2019) increased life expectancy by 0.23 to 0.31 QALYs in non-dialysis patients with stages 3B to 5 CKD, at a net cost of $20,300 to $78,200/QALY. Adding ezetimibe 10 mg ($0.203/day) increased life expectancy by an additional 0.05 to 0.07 QALYs, at a net cost of $43,600 to $91,500/QALY. The cost-effectiveness findings and policy implications in the UK were similar. In summary, in patients with non-dialysis-dependent CKD, the evidence suggests that statin/ezetimibe combination therapy is a cost-effective treatment to reduce the risk of CVD.",2019,"Net costs below $100,000/QALY (US) or £20,000/QALY (UK) were considered cost-effective.","['patients with non-dialysis chronic kidney disease (CKD', 'patients with non-dialysis-dependent CKD', 'chronic kidney disease']","['statins and ezetimibe', 'lipid lowering with statins and ezetimibe', 'ezetimibe', 'atorvastatin']","['low-density lipoprotein (LDL) cholesterol', 'Net costs below $100,000/QALY (US) or £20,000/QALY (UK', 'life expectancy', 'LDL cholesterol', 'cardiovascular disease (CVD) risk', 'quality-adjusted life years (QALYs) and health care costs', 'cardiovascular risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.016101,"Net costs below $100,000/QALY (US) or £20,000/QALY (UK) were considered cost-effective.","[{'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Schlackow', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, UK.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': 'Kent', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Herrington', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, UK; Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Emberson', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, UK; Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, UK; Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Reith', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, UK.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, UK.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, UK; Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Baigent', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, UK; Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, UK.'}, {'ForeName': 'Borislava', 'Initials': 'B', 'LastName': 'Mihaylova', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, UK; Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, UK. Electronic address: boby.mihaylova@dph.ox.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2019.01.028']
2522,31030167,Walnuts change lipoprotein composition suppressing TNFα-stimulated cytokine production by diabetic adipocyte.,"Walnut consumption can provide both vascular and metabolic health benefits, and walnut-induced changes in lipoprotein particle chemical payloads may be responsible for these health benefits. To explore this possibility with a focus on metabolic health, this study investigated the impact of walnut consumption on lipoprotein lipid composition and changes in LDL anti-inflammatory properties, as reported by inflamed adipocyte. Hypercholesterolemic, postmenopausal females were treated with 40 g/day (i.e., 1.6 servings/day; n=15) of walnuts for 4 weeks. Fatty acids and their oxygenated metabolites, i.e., oxylipins, were quantified in isolated lipoproteins. Human primary adipocytes were exposed to LDL and TNFα-stimulated adipokine production was measured. Walnut treatment elevated α-linolenic acid and its epoxides in all lipoproteins and depleted mid-chain alcohols in VLDL and LDL, but not HDL. Walnuts also reduced TNFα-induced diabetic adipocyte production of IL-6 (-48%, P=.0006) and IL-8 (-30%, P=.01), changes inversely correlated with levels of α-linolenic acid-derived epoxides but not α-linolenic acid itself. In conclusion, modest walnut consumption can alter lipoprotein lipid profiles and enhance their ability to inhibit TNFα-dependent pro-inflammatory responses in human diabetic primary adipocytes. Moreover, this study suggests the oxylipins, rather than the parent fatty acids, mediate LDL action of adipocytes.",2019,"Walnuts also reduced TNFα-induced diabetic adipocyte production of IL-6 (-48%, P=.0006) and IL-8","['Hypercholesterolemic, postmenopausal females']",[],"['IL-8', 'LDL and TNFα-stimulated adipokine production', 'lipoprotein lipid composition and changes in LDL anti-inflammatory properties', 'lipoprotein lipid profiles', 'TNFα-induced diabetic adipocyte production of IL-6']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.0344236,"Walnuts also reduced TNFα-induced diabetic adipocyte production of IL-6 (-48%, P=.0006) and IL-8","[{'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Borkowski', 'Affiliation': 'Dept. of Nutritional Sciences, The Pennsylvania State University, University Park, PA; West Coast Metabolomics Center, Genome Center, University of California Davis, Davis, CA; Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA. Electronic address: kborkowski@ucdavis.edu.'}, {'ForeName': 'Sun J', 'Initials': 'SJ', 'LastName': 'Yim', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA.'}, {'ForeName': 'Roberta R', 'Initials': 'RR', 'LastName': 'Holt', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hackman', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA.'}, {'ForeName': 'Carl L', 'Initials': 'CL', 'LastName': 'Keen', 'Affiliation': 'Department of Nutrition, University of California Davis, Davis, CA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newman', 'Affiliation': 'West Coast Metabolomics Center, Genome Center, University of California Davis, Davis, CA; Department of Nutrition, University of California Davis, Davis, CA; Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA.'}, {'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Shearer', 'Affiliation': 'Dept. of Nutritional Sciences, The Pennsylvania State University, University Park, PA.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2019.03.004']
2523,31048072,Alternative classification of identical concepts in different terminologies: Different ways to view the world.,"In previous research, we have studied concepts that occur in pairs of medical terminologies and are known to be identical, because they have the same ID number in the Unified Medical Language System (UMLS). We observed that such concepts rarely have exactly the same sets of children (=subconcepts) in the two terminologies. The number of common children was found to vary widely. A special situation was identified where the children in one terminology relate to the common parent in a very different way than the children in the other terminology. For example, children in one terminology might subdivide a parent concept by anatomical location in one terminology and by disease kind in the other terminology. We coined the term ""alternative classification"" (of the same parent concept) for such situations. In previous work, only human experts could recognize alternative classifications. In this paper, we present a mathematically expressed criterion for likely cases of alternative classifications. We compare the recommendations of this criterion, expressed by a mathematical quantity called ""EFI"" becoming zero, with the decisions of a human expert. It is found that the human expert agreed with the criterion in 72% of all cases, which is a big improvement over having no computable criterion at all. Besides alternative classifications, common parent concepts in a pair of terminologies might also indicate a possible import of a child concept missing in one terminology, different granularities, or errors in either one of the two terminologies. In this paper, we further investigate different kinds of alternative classifications.",2019,"It is found that the human expert agreed with the criterion in 72% of all cases, which is a big improvement over having no computable criterion at all.",[],[],[],[],[],[],,0.0146277,"It is found that the human expert agreed with the criterion in 72% of all cases, which is a big improvement over having no computable criterion at all.","[{'ForeName': 'Vipina K', 'Initials': 'VK', 'LastName': 'Keloth', 'Affiliation': 'New Jersey Institute of Technology, Newark, NJ, USA. Electronic address: vk396@njit.edu.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Gai', 'Initials': 'G', 'LastName': 'Elhanan', 'Affiliation': 'Desert Research Institute, Reno, Nevada, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Geller', 'Affiliation': 'New Jersey Institute of Technology, Newark, NJ, USA.'}]",Journal of biomedical informatics,['10.1016/j.jbi.2019.103193']
2524,31642037,Using Matching-Adjusted Indirect Comparisons and Network Meta-analyses to Compare Efficacy of Brexanolone Injection with Selective Serotonin Reuptake Inhibitors for Treating Postpartum Depression.,"BACKGROUND


Brexanolone injection, the first therapy approved by the US FDA for the treatment of postpartum depression (PPD) in adults, has been shown to produce a significantly greater decrease in the Hamilton Rating Scale for Depression (HAM-D) total score than placebo in randomised controlled trials (RCTs) of women with PPD.
OBJECTIVES


Given the rapid effect of brexanolone injection (within 60 h) sustained throughout the length of the trials (30 days), we sought to compare its efficacy data against selective serotonin reuptake inhibitors (SSRIs), the class of antidepressants most commonly prescribed for PPD, using HAM-D and Edinburgh Postnatal Depression Scale (EPDS) outcomes from currently available RCTs.
METHODS


We extracted data from 26 studies identified in a systematic literature review of pharmacological and pharmacological/nonpharmacological combination therapies in PPD. Six studies were suitable to form evidence networks through which to perform indirect treatment comparisons (ITCs) of HAM-D and EPDS outcomes between brexanolone and SSRIs. Having assessed the comparability and suitability of the available evidence for analysis, we discovered significant heterogeneity in the study designs, most notably in the placebo arms of the trials. We therefore conducted matching-adjusted indirect comparisons (MAICs) between brexanolone and the placebo arms of comparator studies, subsequently using the MAIC results of brexanolone versus placebo, and results for SSRIs versus placebo, to form ITCs of brexanolone versus SSRIs at three separate time points-day 3, week 4 and last observation. ITCs were calculated as the differences in change from baseline (CFB) in HAM-D and, separately, CFB in EPDS, between treatments, and reported with 95% confidence intervals (CIs).
RESULTS


For all time points, MAICs showed larger differences in CFB for brexanolone compared with SSRIs. Differences (95% CIs) between brexanolone and SSRIs were 12.79 (8.04-17.53) [day 3], 5.87 (- 1.62 to 13.37) [week 4] and 0.97 (- 6.35 to 8.30) [last observation] for the HAM-D. For the EPDS, the differences in CFB were 7.98 (5.32-10.64) [day 3], 6.35 (3.13-9.57) [week 4] and 4.05 (0.79-7.31) [last observation]. Other analytical approaches are also presented to demonstrate the similarity of results, using a network meta-analysis approach, and the importance of using the MAIC method to control for the important heterogeneity between placebo arms.
CONCLUSIONS


Acknowledging the limitations of ITCs and this evidence base, when compared with SSRIs, these analyses suggest that brexanolone demonstrated larger differences in CFB for both patient- and clinician-reported PPD outcomes and at all investigated time points after adjusting for differences between placebos in the included studies.",2019,"For all time points, MAICs showed larger differences in CFB for brexanolone compared with SSRIs.",['women with PPD'],"['brexanolone injection', 'brexanolone versus placebo', 'brexanolone', 'Brexanolone Injection with Selective Serotonin Reuptake Inhibitors', 'placebo']","['HAM-D and Edinburgh Postnatal Depression Scale (EPDS) outcomes', 'CFB', 'Hamilton Rating Scale for Depression (HAM-D) total score', 'ITCs']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}]","[{'cui': 'C4765158', 'cui_str': 'brexanolone Injection'}, {'cui': 'C4548848', 'cui_str': 'brexanolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0203939', 'cui_str': 'Osteopathic manipulation, indirect forces'}]",,0.160662,"For all time points, MAICs showed larger differences in CFB for brexanolone compared with SSRIs.","[{'ForeName': 'Miranda C', 'Initials': 'MC', 'LastName': 'Cooper', 'Affiliation': 'BresMed Health Solutions Ltd, Sheffield, UK.'}, {'ForeName': 'Hannah S', 'Initials': 'HS', 'LastName': 'Kilvert', 'Affiliation': 'BresMed Health Solutions Ltd, Manchester, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hodgkins', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Neil S', 'Initials': 'NS', 'LastName': 'Roskell', 'Affiliation': 'BresMed Health Solutions Ltd, Manchester, UK.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Eldar-Lissai', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA. Adi.Eldar-Lissai@sagerx.com.'}]",CNS drugs,['10.1007/s40263-019-00672-w']
2525,31648772,Femoral Access With or Without Vascular Closure Device or Radial Access in Acute Coronary Syndrome.,,2019,,['Acute Coronary Syndrome'],['Femoral Access With or Without Vascular Closure Device or Radial\xa0Access'],[],"[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3504161', 'cui_str': 'Vascular Closure Devices'}, {'cui': 'C0442038', 'cui_str': 'Radial'}]",[],,0.138837,,"[{'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Gragnano', 'Affiliation': ''}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Manavifar', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gargiulo', 'Affiliation': ''}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Sunnåker', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Galea', 'Affiliation': ''}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Frigoli', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Calabrò', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.06.027']
2526,31813028,Ejaculatory disorders after prostatic artery embolization: a reassessment of two prospective clinical trials.,"PURPOSE


This study aims to specify and explain the previous findings of unexpectedly high rates of ejaculatory disorders, i.e. 56%, found after prostatic artery embolization (PAE) in a randomized controlled trial comparing safety and efficacy of PAE and transurethral resection of the prostate (TURP).
PATIENTS AND METHODS


Case report forms of the randomized controlled trial were analyzed to specify the grade of postoperative ejaculatory dysfunction 3 months postoperatively. In addition, study participants with assessable ejaculation were asked to complete the four-item Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD) referring to their ejaculatory function at present, as well as before treatment and 3 months after. Potential explanations for ejaculatory disorders after PAE were derived from histological examination of five radical prostatectomy specimens of patients that underwent PAE 6 weeks before radical prostatectomy within a proof-of-concept trial at the study site, St. Gallen Cantonal Hospital. An experienced uropathologist systematically examined the whole-gland embedded tissue with focus on structures that are involved into ejaculation.
RESULTS


While patients after TURP predominantly suffered from anejaculation (52%), diminished ejaculation was found more often after PAE (40%). Significantly higher MSHQ-EjD scores were found 3 months after PAE and at a median follow-up of 31 months. Histological examination showed marked changes of structures involved into ejaculation (e.g., prostatic glands, seminal vesicles, ejaculatory ducts) after PAE.
CONCLUSION


Although anejaculation occurs less frequently after PAE (16%) compared to TURP (52%), patients have to be informed about the relevant risk of ejaculatory disorders, especially diminished ejaculation.",2020,"Although anejaculation occurs less frequently after PAE (16%) compared to TURP (52%), patients have to be informed about the relevant risk of ejaculatory disorders, especially diminished ejaculation.","['participants with assessable ejaculation', 'Ejaculatory disorders after prostatic artery embolization']","['prostatic artery embolization (PAE', 'PAE and transurethral resection of the prostate (TURP', 'TURP']","['MSHQ-EjD scores', 'ejaculation', 'Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD) referring to their ejaculatory function', 'structures involved into ejaculation (e.g., prostatic glands, seminal vesicles, ejaculatory ducts']","[{'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0235969', 'cui_str': 'Disorder of ejaculation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0036628', 'cui_str': 'Seminal vesicle structure'}, {'cui': 'C0013747', 'cui_str': 'Ejaculatory duct structure'}]",,0.0316888,"Although anejaculation occurs less frequently after PAE (16%) compared to TURP (52%), patients have to be informed about the relevant risk of ejaculatory disorders, especially diminished ejaculation.","[{'ForeName': 'Gautier', 'Initials': 'G', 'LastName': 'Müllhaupt', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland. gautier.muellhaupt@kssg.ch.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hechelhammer', 'Affiliation': 'Department of Radiology and Nuclear Medicine, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Pierre-André', 'Initials': 'PA', 'LastName': 'Diener', 'Affiliation': 'Department of Pathology, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Engeler', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Güsewell', 'Affiliation': 'Clinical Trials Unit, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Schmid', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Mordasini', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Abt', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}]",World journal of urology,['10.1007/s00345-019-03036-7']
2527,31833792,Aglepristone and cloprostenol combination in the termination of late-term pregnancy in queens.,"OBJECTIVES


Termination rates for the highly recommended aglepristone (AGL) treatment are low in late-term pregnancy in queens. We studied the effects of an AGL and cloprostenol (CLO) combination in the termination of late-term pregnancy.
METHODS


Pregnant queens were assigned to two groups. Queens in the AGL group (n = 10) received AGL 10 mg/kg, twice, 24 h apart. Queens in the AGL-CLO group (n = 9) were additionally injected with a single dose of CLO (5 μg/kg) 24 h after the second dose of AGL. Progesterone, 17beta(β)-oestradiol, cortisol, oxytocin and prostaglandin F2alpha (PGF2α) metabolite were measured in sera obtained at days 0, 1 and 2, and on the day of abortion.
RESULTS


Average gestational age in both groups was similar (AGL 38.61 ± 0.91 days vs AGL-CLO 39.39 ± 1.35 days;  P  >0.05). Termination rates were 80% and 100% in the AGL and AGL-CLO groups, respectively ( P  <0.05). Fetal expulsion time was significantly longer ( P  <0.001) in the AGL group (96.9 ± 6 h) compared with the AGL-CLO group (69.8 ± 3.3 h). Duration of abortion was 19.8 ± 2.6 h and 12.6 ± 1.4 h in the AGL and AGL-CLO groups, respectively ( P  <0.05). Both treatments were well tolerated. Significantly ( P  <0.05) lower serum progesterone concentrations were observed in both groups at the day of abortion and concentrations in the AGL-CLO group (4.19 ± 0.80 ng/ml) were lower than in the AGL group (9.89 ± 2.21 ng/ml;  P  <0.05).
CONCLUSIONS AND RELEVANCE


AGL and CLO combination increases pregnancy termination rate in late-term pregnant queens. In addition, CLO contributes to a decrease in luteal function in AGL-treated late-term pregnant queens.",2020,"Significantly ( P  <0.05) lower serum progesterone concentrations were observed in both groups at the day of abortion and concentrations in the AGL-CLO group (4.19 ± 0.80 ng/ml) were lower than in the AGL group (9.89 ± 2.21 ng/ml;  P  <0.05).
","['Pregnant queens', 'late-term pregnancy in queens']","['aglepristone (AGL', 'AGL and cloprostenol (CLO) combination', 'AGL', 'CLO combination', 'Aglepristone and cloprostenol combination']","['Termination rates', 'luteal function', 'Duration of abortion', 'tolerated', 'Progesterone, 17beta(β)-oestradiol, cortisol, oxytocin and prostaglandin F2alpha (PGF2α) metabolite', 'Fetal expulsion time', 'serum progesterone concentrations', 'pregnancy termination rate']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy'}]","[{'cui': 'C0963581', 'cui_str': 'aglepristone'}, {'cui': 'C0009030', 'cui_str': 'Cloprostenol'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0012471', 'cui_str': 'Dinoprost'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0392535', 'cui_str': 'Termination of pregnancy'}]",,0.0604686,"Significantly ( P  <0.05) lower serum progesterone concentrations were observed in both groups at the day of abortion and concentrations in the AGL-CLO group (4.19 ± 0.80 ng/ml) were lower than in the AGL group (9.89 ± 2.21 ng/ml;  P  <0.05).
","[{'ForeName': 'Kubra', 'Initials': 'K', 'LastName': 'Karakas Alkan', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Veterinary Medicine, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Alkan', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Veterinary Medicine, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Gizem', 'Initials': 'G', 'LastName': 'Tez', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Veterinary Medicine, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Halit', 'Initials': 'H', 'LastName': 'Kanca', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Veterinary Medicine, Ankara University, Ankara, Turkey.'}]",Journal of feline medicine and surgery,['10.1177/1098612X19892087']
2528,32964933,Rural-urban differences in body mass index and obesity-related behaviors among low-income preschoolers.,"BACKGROUND


With one in eight preschoolers classified as obese in the USA, childhood obesity remains a significant public health issue. This study examined rural-urban differences in low-income preschoolers' body mass index z-scores (BMIz), eating behaviors, dietary quality, physical activity (PA) and screen time.
METHODS


Pre-intervention data from 572 preschooler-parent dyads participating in a randomized, controlled obesity prevention trial in the Midwest USA were analyzed. We examined the associations among living in rural versus urban areas, child BMIz and child obesity-related behaviors, including eating behaviors, dietary quality, PA and screen time.
RESULTS


Rural children had higher BMIz, more emotional overeating behaviors and more time spent playing outdoors compared with urban children. We found no associations between children living in rural versus urban areas and dietary quality and screen time.
CONCLUSIONS


The study found that rural-urban differences in BMIz may start as early as 3-4 years of age, if not earlier. To reverse the weight-related health disparities between rural and urban low-income preschoolers, structural changes in rural locations and family supports around coping skills may be needed.",2020,"RESULTS


Rural children had higher BMIz, more emotional overeating behaviors and more time spent playing outdoors compared with urban children.","['572 preschooler-parent dyads participating in a randomized, controlled obesity prevention trial in the Midwest USA', 'rural-urban differences in low-income preschoolers', 'Rural children']",[],"['time spent playing outdoors', 'emotional overeating behaviors', 'dietary quality and screen time', 'body mass index z-scores (BMIz), eating behaviors, dietary quality, physical activity (PA) and screen time', 'eating behaviors, dietary quality, PA and screen time']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0326286,"RESULTS


Rural children had higher BMIz, more emotional overeating behaviors and more time spent playing outdoors compared with urban children.","[{'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Contreras', 'Affiliation': 'Michigan State University Extension, Michigan State University, East Lansing, MI 48824, USA.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Martoccio', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland College Park, College Park, MD 20742, USA.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Brophy-Herb', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University, East Lansing, MI 48824, USA.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Horodynski', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI 48824, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Peterson', 'Affiliation': 'Department of the Nutritional Sciences, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Miller', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Senehi', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Sturza', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Kaciroti', 'Affiliation': 'Department of Pediatrics and Department of Biostatistics, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Lumeng', 'Affiliation': 'Department of Pediatrics and Department of Nutritional Sciences, University of Michigan, Ann Arbor, MI 48109, USA.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdaa162']
2529,32964939,The freeze-all strategy versus agonist triggering with low-dose hCG for luteal phase support in IVF/ICSI for high responders: a randomized controlled trial.,"STUDY QUESTION


Does the freeze-all strategy in high-responders increase pregnancy rates and improve safety outcomes when compared with GnRH agonist triggering followed by low-dose hCG intensified luteal support with a fresh embryo transfer?
SUMMARY ANSWER


Pregnancy rates after either fresh embryo transfer with intensified luteal phase support using low-dose hCG or the freeze-all strategy did not vary significantly; however, moderate-to-severe ovarian hyperstimulation syndrome (OHSS) occurred more frequently in the women who attempted a fresh embryo transfer.
WHAT IS KNOWN ALREADY


Two strategies following GnRH agonist triggering (the freeze-all approach and a fresh embryo transfer attempt using a low-dose of hCG for intensified luteal phase support) are safer alternatives when compared with conventional hCG triggering with similar pregnancy outcomes. However, these two strategies have never been compared head-to-head in an unrestricted predicted hyper-responder population.
STUDY DESIGN, SIZE, DURATION


This study included women with an excessive response to ovarian stimulation (≥18 follicles measuring ≥11 mm) undergoing IVF/ICSI in a GnRH antagonist suppressed cycle between 2014 and 2017. Our primary outcome was clinical pregnancy at 7 weeks after the first embryo transfer. Secondary outcomes included live birth and the development of moderate-to-severe OHSS.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Following GnRH agonist triggering, women were randomized either to cryopreserve all good-quality embryos followed by a frozen embryo transfer in an subsequent artificial cycle or to perform a fresh embryo transfer with intensified luteal phase support (1500 IU hCG on the day of oocyte retrieval, plus oral estradiol 2 mg two times a day, plus 200 mg of micronized vaginal progesterone three times a day).
MAIN RESULTS AND THE ROLE OF CHANCE


A total of 212 patients (106 in each arm) were recruited in the study, with three patients (one in the fresh embryo transfer group and two in the freeze-all group) later withdrawing their consent to participate in the study. One patient in the freeze-all group became pregnant naturally (clinical pregnancy diagnosed 38 days after randomization) prior to the first frozen embryo transfer. The study arms did not vary significantly in terms of the number of oocytes retrieved and embryos produced/transferred. The intention to treat clinical pregnancy and live birth rates (with the latter excluding four cases lost to follow-up: one in the fresh transfer and three in the freeze-all arms, respectively) after the first embryo transfer did not vary significantly among the fresh embryo transfer and freeze-all study arms: 51/105 (48.6%) versus 57/104 (54.8%) and 41/104 (39.4%) versus 42/101 (41.6%), respectively (relative risk for clinical pregnancy 1.13, 95% CI 0.87-1.47; P = 0.41). However, moderate-to-severe OHSS occurred solely in the group that received low-dose hCG (9/105, 8.6%, 95% CI 3.2% to 13.9% vs 0/104, 95% CI 0 to 3.7, P < 0.01).
LIMITATIONS, REASONS FOR CAUTION


The sample size calculation was based on a 19% absolute difference in terms of clinical pregnancy rates, therefore smaller differences, as observed in the trial, cannot be reliably excluded as non-significant.
WIDER IMPLICATIONS OF THE FINDINGS


This study offers the first comparative analysis of two common strategies applied to women performing IVF/ICSI with a high risk to develop OHSS. While pregnancy rates did not vary significantly, a fresh embryo transfer with intensified luteal phase support may still not avoid the risk of moderate-to-severe OHSS and serious consideration should be made before recommending it as a routine first-line treatment. Future trials may allow us to confirm these findings.
STUDY FUNDING/COMPETING INTEREST(S)


The authors have no conflicts of interest to disclose. No external funding was obtained for this study.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov identifier NCT02148393.
TRIAL REGISTRATION DATE


28 May 2014.
DATE OF FIRST PATIENT’S ENROLMENT


30 May 2014.",2020,"Does the freeze-all strategy in high-responders increase pregnancy rates and improve safety outcomes when compared with GnRH agonist triggering followed by low-dose hCG intensified luteal support with a fresh embryo transfer?
","['women with an excessive response to ovarian stimulation (≥18 follicles measuring ≥11 mm) undergoing IVF/ICSI in a GnRH antagonist suppressed cycle between 2014 and 2017', 'women performing IVF/ICSI with a high risk to develop OHSS', '212 patients (106 in each arm) were recruited in the study, with three patients (one in the fresh embryo transfer group and two in the freeze-all group) later withdrawing their consent to participate in the study']",['micronized vaginal progesterone'],"['pregnancy rates', 'moderate-to-severe ovarian hyperstimulation syndrome (OHSS', 'intention to treat clinical pregnancy and live birth rates', 'number of oocytes retrieved and embryos produced/transferred', 'live birth and the development of moderate-to-severe OHSS', 'clinical pregnancy rates', 'clinical pregnancy', 'moderate-to-severe OHSS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",212.0,0.170746,"Does the freeze-all strategy in high-responders increase pregnancy rates and improve safety outcomes when compared with GnRH agonist triggering followed by low-dose hCG intensified luteal support with a fresh embryo transfer?
","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Santos-Ribeiro', 'Affiliation': 'IVIRMA Lisboa, Avenida Infante Dom Henrique 333 H 1-9, Lisbon, Portugal.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Mackens', 'Affiliation': 'Center for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Popovic-Todorovic', 'Affiliation': 'Center for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Racca', 'Affiliation': 'Center for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Nikolaos P', 'Initials': 'NP', 'LastName': 'Polyzos', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Medicine, Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Lisbet', 'Initials': 'L', 'LastName': 'Van Landuyt', 'Affiliation': 'Center for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Drakopoulos', 'Affiliation': 'Center for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'de Vos', 'Affiliation': 'Center for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Tournaye', 'Affiliation': 'Center for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Blockeel', 'Affiliation': 'Center for Reproductive Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa226']
2530,32965000,Dehydroepiandrosterone supplementation improves ovarian reserve and pregnancy rates in poor responders.,"OBJECTIVE


We investigated whether DHEA supplementation had an impact on ovarian reserve parameters and pregnancy rates in patients with poor ovarian response (POR) and primary ovarian insufficiency (POI).
PATIENTS AND METHODS


A total of 34 people, 6 patients with POI and 28 patients with POR, were included in the study. The patients in the POR group consisted of two different groups: diminished ovarian reserve (DOR) and premature ovarian failure (PMOF). Patients in the POI and POR group were given 50 mg DHEA supplementation daily for 5 months. The primary outcome was to determine spontaneous clinical pregnancy rates. The monthly changes in the serum hormone levels and AFC were recorded for five months. AMH levels were also measured before and after treatment.
RESULTS


The total follow-up time was 152 cycles. The number of pregnancies during the follow-up period was 9. The ratio of pregnancies to the number of patients was 26.5% and the rate per cycle was 5.9%. While 8 of 9 pregnancies resulted in a live birth, one resulted in a miscarriage. The rate of abortion was 11.1%. The mean AFC was 0 to 5 before treatment. Following DHEA administration, a significant increase was detected in 30.8% of the patients. There was an increase in AMH levels after DHEA, but this was not significant. The live birth rate and pregnancy rate per cycle were significantly higher in POR patients than those in POF. Patients with POF had no pregnancy. Although the PMOF patients were younger than the DOR patients, the rate of pregnancy (36% vs. 29%), and pregnancy rates per cycle (8.5% vs. 6.35%) were higher in the DOR group. The rates of live birth were the same in the PMOF and DOR groups (29% vs. 29%).
CONCLUSIONS


Oral DHEA supplementation improves both ovarian reserve and pregnancy rates in women with POR.",2020,"The rates of live birth were the same in the PMOF and DOR groups (29% vs. 29%).
","['Patients with POF had no pregnancy', 'women with POR', 'patients with poor ovarian response (POR) and primary ovarian insufficiency (POI', '34 people, 6 patients with POI and 28 patients with POR, were included in the study']","['Oral DHEA supplementation', 'Dehydroepiandrosterone supplementation', 'DHEA supplementation']","['spontaneous clinical pregnancy rates', 'AMH levels', 'pregnancy rates per cycle', 'live birth rate and pregnancy rate per cycle', 'ovarian reserve parameters and pregnancy rates', 'number of pregnancies', 'rate of pregnancy', 'mean AFC', 'serum hormone levels and AFC', 'ovarian reserve (DOR) and premature ovarian failure (PMOF', 'live birth', 'rates of live birth', 'ovarian reserve and pregnancy rates', 'rate of abortion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",6.0,0.227669,"The rates of live birth were the same in the PMOF and DOR groups (29% vs. 29%).
","[{'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Ozcil', 'Affiliation': 'Department of Obstetrics and Gynecology, Mustafa Kemal University School of Medicine, Hatay, Turkey. mustafadoganozcil2@gmail.com.'}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202009_22856']
2531,32965002,"Postoperative treatment with phytotheraphy Graminex G63 (CERNILEN-Flogo®) after greenlight laser XPS (180W) photovaporization of the prostate (PVP), can affect patient's quality of life?","OBJECTIVE


Phytotherapic treatment as Cernilen-flogo® is commonly used to treat chronic pelvic pain, chronic prostatitis, and BPE (benign prostatic enlargement). In our study, for the first time, we aim to evaluate postoperatively Cernilen-flogo® therapy in patients with BPE/LUTS (lower urinary tract symptoms) previously treated with Greenlight laser XPS (180W) photovaporization of prostate (PVP) to improve surgical outcomes.
MATERIALS AND METHODS


We collected data from patients treated with PVP for BPE/LUTS international prostate symptom score (IPSS) >20 unresponding to conventional treatment. Two groups of patients were analyzed: Group A including 15 patients (50%) treated postoperatively with Cernilen-flogo® vs. no treatment Group B. One expert surgeon performed all the procedures.
RESULTS


30 patients included with BPE/LUTs previously treated with PVP. There was no difference between patients' demographic, median age, prostate volume and PSA (prostate specific antigen) level. All patients had a postoperative evaluation after 30-45 days. Patients with postoperative complications (acute urinary retention, postoperative hematuria) were excluded from our study. All patients had a preoperative and postoperative evaluation of IPSS, bother score (BS) and pelvic discomfort (visual analogic scale VAS). Preoperatively there was no significative difference in IPSS, BS and VAS. IPSS Group A was postoperatively 7.13 (SD 1.64) and Group B was 7.33 (SD 1.58) (p=0.67); BS Group A was postoperatively 1.33 (SD 0.81), Group B was 1.73 (SD 1.09) (p=0.30), and VAS Group A was 2.73 (SD 1.9) and Group B was 4.33 (SD 1.58) (p=0.004) showing a statistically significative difference between the two groups in pelvic discomfort with a better outcome in patients treated with Cernilen-flogo®.
CONCLUSIONS


Our study showed that Cernilen-flogo® treatment after PVP is effective and minimize patient's pelvic discomfort showed by lower VAS level resulting in better postoperatively patient's quality of life (QOL).",2020,"Preoperatively there was no significative difference in IPSS, BS and VAS.","['We collected data from patients treated with PVP for BPE/LUTS international prostate symptom score (IPSS) >20 unresponding to conventional treatment', 'patients with BPE/LUTS (lower urinary tract symptoms', '30 patients included with BPE/LUTs previously treated with', 'Patients with postoperative complications (acute urinary retention, postoperative hematuria']","['greenlight laser XPS (180W) photovaporization of the prostate (PVP', 'IPSS', 'phytotheraphy Graminex G63 (CERNILEN-Flogo®', 'postoperatively Cernilen-flogo® therapy', 'PVP', 'Cernilen-flogo® vs. no treatment Group B. One expert surgeon performed all the procedures', 'Greenlight laser XPS (180W) photovaporization of prostate (PVP']","['preoperative and postoperative evaluation of IPSS, bother score (BS) and pelvic discomfort (visual analogic scale VAS', 'IPSS, BS and VAS', 'pelvic discomfort', ""patients' demographic, median age, prostate volume and PSA (prostate specific antigen) level""]","[{'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220663', 'cui_str': 'Blepharophimosis syndrome'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C2700282', 'cui_str': 'Electron Spectroscopy for Chemical Analysis'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1535975', 'cui_str': 'Pelvic discomfort'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0522017,"Preoperatively there was no significative difference in IPSS, BS and VAS.","[{'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Di Pasquale', 'Affiliation': 'Department of Urology, ""S. Salvatore"" Hospital, Urology Unit, L\'Aquila, Italy; ASL Abruzzo 1, L\'Aquila, Italy. alessandra.cassani73@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cassani', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Masciovecchio', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zasa', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ranieri', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Romano', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Di Clemente', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202009_22858']
2532,32962898,A nurse- and peer-led psycho-educational intervention to support women with gynaecological cancers receiving curative radiotherapy: The PeNTAGOn randomised controlled trial - ANZGOG 1102.,"OBJECTIVE


Radiotherapy for gynaecological cancer is associated with multiple adverse effects. This randomised controlled trial evaluated the impact of a combined nurse- and peer-led psycho-educational intervention on psychological distress, preparation for treatment, quality of life, psychosexual function, unmet needs and vaginal stenosis.
METHODS


Eligible women had a confirmed diagnosis of gynaecological cancer, scheduled to receive radiotherapy with curative intent, aged ≥18 years, and able to read and write English. Participants randomly assigned one-to-one to either four nurse-led consultations plus four peer-led telephone sessions, or to usual care. Participants completed study measures at baseline, immediately before first radiotherapy (FU1), and four weeks (FU2), three (FU3), six (FU4), and 12 months (FU5) post radiotherapy. The primary outcomes were psychological distress at FU1 and FU2 measured by the Hospital Anxiety and Depression Scale.
RESULTS


Of 840 eligible participants, 625 were approached and 319 (51%) consented; 158 assigned to intervention, 160 to usual care with 1 withdrawing before randomisation. Between-groups differences for primary outcomes were trivial- and small-sized, (both p > 0.05). Notable effects on secondary outcomes favouring the intervention at FU2 included preparation for treatment (sensory/psychological concerns, d = 0.57; and procedural concerns, d = 0.52) and specific needs domains (sexuality needs, d = 0.38; and health system and information needs, d = 0.41).
CONCLUSIONS


There was no evidence that a nurse- and peer-led intervention had a beneficial effect on psychological distress compared to usual care. However, improved treatment readiness and lower health system and sexuality needs indicate the intervention may have addressed outcomes known to be important to this population.",2020,There was no evidence that a nurse- and peer-led intervention had a beneficial effect on psychological distress compared to usual care.,"['women with gynaecological cancers receiving', 'Eligible women had a confirmed diagnosis of gynaecological cancer, scheduled to receive radiotherapy with curative intent, aged ≥18\xa0years, and able to read and write English', '840 eligible participants, 625 were approached and 319 (51%) consented; 158 assigned to intervention, 160 to usual care with 1 withdrawing before randomisation']","['curative radiotherapy', 'combined nurse- and peer-led psycho-educational intervention', 'four nurse-led consultations plus four peer-led telephone sessions, or to usual care', 'nurse- and peer-led psycho-educational intervention']","['psychological distress', 'psychological distress, preparation for treatment, quality of life, psychosexual function, unmet needs and vaginal stenosis', 'psychological distress at FU1 and FU2 measured by the Hospital Anxiety and Depression Scale', 'FU2 included preparation for treatment (sensory/psychological concerns, d\xa0=\xa00.57; and procedural concerns, d\xa0=\xa00.52) and specific needs domains (sexuality needs, d\xa0=\xa00.38; and health system and information needs, d\xa0=\xa00.41']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0586740', 'cui_str': 'Able to read'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C4517838', 'cui_str': '625'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C4517456', 'cui_str': '0.38'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",840.0,0.189686,There was no evidence that a nurse- and peer-led intervention had a beneficial effect on psychological distress compared to usual care.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schofield', 'Affiliation': 'Behavioural Sciences Unit, Peter MacCallum Cancer Centre, 305 Grattan Street, Parkville, VIC 3000, Australia; Department of Psychological Science, Iverson Health Innovation Research Institute Swinburne University of Technology, John St, Hawthorn, VIC 3122, Australia; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, VIC 3010, Australia. Electronic address: Pschofield@swin.edu.au.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gough', 'Affiliation': 'Cancer Care Delivery Research, Department of Cancer Experiences, Peter MacCallum Cancer Centre, 305 Grattan Street, Parkville, VIC 3000, Australia. Electronic address: Karla.gough@petermac.org.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pascoe', 'Affiliation': 'Behavioural Sciences Unit, Peter MacCallum Cancer Centre, 305 Grattan Street, Parkville, VIC 3000, Australia; Institute for Health and Sport, Victoria University, Ballarat Road, Footscray, VIC 3011, Australia. Electronic address: Michaela.Pascoe@vu.edu.au.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bergin', 'Affiliation': 'Cancer Council Victoria, 615 St Kilda Road, Melbourne, VIC 3004, Australia. Electronic address: Rebecca.Bergin@cancervic.org.au.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'White', 'Affiliation': ""Cancer Nursing Research Unit, Level 6-North, Chris O'Brien Lifehouse, The University of Sydney, NSW 2006, Australia. Electronic address: Kate.white@sydney.edu.au.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mileshkin', 'Affiliation': 'Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, VIC 3010, Australia; Department of Medical Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Parkville, VIC 3000, Australia. Electronic address: Linda.mileshkin@petermac.org.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bernshaw', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Parkville, VIC 3000, Australia. Electronic address: David.Bernshaw@petermac.org.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kinnane', 'Affiliation': 'Department of Radiation Oncology, Peter MacCallum Cancer Centre, 305 Grattan Street, Parkville, VIC 3000, Australia. Electronic address: Nicole.kinnane@petermac.org.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jackson', 'Affiliation': 'Prince of Wales Clinical School, UNSW Sydney, NSW 2052, Australia. Electronic address: Michael.Jackson2@health.nsw.gov.au.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Do', 'Affiliation': 'Department of Radiation Oncology, Liverpool Cancer Therapy Centre, 1 Campbell St, Liverpool, NSW 2170, Australia; South Western Sydney Clinical School, University of New South Wales Medicine, 18 High St, Kensington, NSW 2052, Australia. Electronic address: Viet.do@health.nsw.gov.au.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'Department of Gynaecological Oncology, Westmead Hospital, Hawkesbury Road, Westmead, NSW 2145, Australia. Electronic address: Alison.brand@health.nsw.gov.au.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Aranda', 'Affiliation': 'Cancer Council Australia, 14/477 Pitt St, Sydney, NSW 2000, Australia. Electronic address: Sanchia.aranda@cancer.org.au.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cheuk', 'Affiliation': ""Cancer Care Services, Joyce Tweddell Building, Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD 4029, Australia. Electronic address: Robyn.Cheuk@health.qld.gov.au.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Drosdowsky', 'Affiliation': 'Cancer Care Delivery Research, Department of Cancer Experiences, Peter MacCallum Cancer Centre, 305 Grattan Street, Parkville, VIC 3000, Australia. Electronic address: Allison.Drosdowsky@petermac.org.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Penberthy', 'Affiliation': 'Behavioural Sciences Unit, Peter MacCallum Cancer Centre, 305 Grattan Street, Parkville, VIC 3000, Australia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Juraskova', 'Affiliation': 'Centre of Medical Psychology and Evidence-based Decision-making (CeMPED), School of Psychology, The University of Sydney, Brennan MacCallum Building A18, Manning Road, Camperdown, NSW 2050, Australia. Electronic address: ilona.juraskova@sydney.edu.au.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.09.016']
2533,32962906,Clinical outcomes comparison of distal radius fractures between two conservative treatment methods: Below-arm cast versus reverse sugar tong splint.,"BACKGROUND


The purpose of this prospective randomized study was to compare a new reverse sugar tong splint technique with a below-arm cast, in terms of patient radiological and clinical outcomes.
METHODS


One hundred and forty patients who presented to our clinic between April 2017 and March 2019 were randomly divided into two groups: 70 received reverse sugar tong (RST group) and 70 received below arm cast (BAC group). Clinical and radiological follow-up was performed 7-10 days, three weeks, 5 or 6 weeks, 12 weeks and one year after the treatment. Clinical outcomes including wrist range of motion, complication rates, Health Assessment Questionnaire (HAQ) score at end of treatment, Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire and Mayo Elbow Performance score (MEPS) score at 12 weeks and last follow-up.
RESULTS


Finally, sixty-five patients were treated with BAC, and their average age was 58.2 years and sixty-two patients with an average age of 57.4 years were treated with RST were completed the radiological and clinical one-year follow-up. There were no significant differences in range of motion, radiological parameters, the Q-DASH and MEPS scores between the groups the 12th week and last visit; however, the HAQ score was significantly higher in the cast group during the 6th visit (p < 0.001). The BAC group had a higher complication rate (40%) than the RST group (19.3%) (p = 0.01).
CONCLUSION


Patient treated with RST had a higher functional status at end of treatment and lower complications when comparing traditional below arm cast.
LEVEL OF EVIDENCE


Level I prognostic randomized controlled trial.",2020,"There were no significant differences in range of motion, radiological parameters, the Q-DASH and MEPS scores between the groups the 12th week and last visit; however, the HAQ score was significantly higher in the cast group during the 6th visit (p < 0.001).","['Finally, sixty-five patients were treated with BAC, and their average age was 58.2 years and sixty-two patients with an average age of 57.4 years were treated with', 'One hundred and forty patients who presented to our clinic between April 2017 and March 2019']","['RST', 'conservative treatment methods: Below-arm cast versus reverse sugar tong splint', 'reverse sugar tong (RST group) and 70 received below arm cast (BAC']","['wrist range of motion, complication rates, Health Assessment Questionnaire (HAQ) score at end of treatment, Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire and Mayo Elbow Performance score (MEPS) score', 'distal radius fractures', 'range of motion, radiological parameters, the Q-DASH and MEPS scores', 'complication rate', 'functional status', 'HAQ score']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0035934', 'cui_str': 'Rubinstein-Taybi syndrome'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0183964', 'cui_str': 'Tong'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}]","[{'cui': 'C0575717', 'cui_str': 'Wrist joint - range of movement'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2960025', 'cui_str': 'Health assessment questionnaire score'}]",65.0,0.0445159,"There were no significant differences in range of motion, radiological parameters, the Q-DASH and MEPS scores between the groups the 12th week and last visit; however, the HAQ score was significantly higher in the cast group during the 6th visit (p < 0.001).","[{'ForeName': 'Savaş', 'Initials': 'S', 'LastName': 'Çamur', 'Affiliation': 'Department of Orthopedics and Traumatology, Umraniye Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Bayram', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey. Electronic address: dr.serkanbayram89@gmail.com.'}, {'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Polat', 'Affiliation': 'Department of Orthopedics and Traumatology, Umraniye Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Muhammet Sefa', 'Initials': 'MS', 'LastName': 'Özcan', 'Affiliation': 'Department of Orthopedics and Traumatology, Şişli Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sefa Giray', 'Initials': 'SG', 'LastName': 'Batıbay', 'Affiliation': 'Department of Orthopedics and Traumatology, Ankara Occupational and Environmental Diseases Hospital, Ankara, Turkey.'}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2020.08.011']
2534,32962926,Impact of targeted trainer feedback via video review on trainee performance of laparoscopic cholecystectomy.,"INTRODUCTION


Tools for improving operative performance for surgical trainees are increasingly desirable, particularly in the context of EWTD and 'run-through' training programmes. In addition, positive direct trainer feedback to trainees can improve skill acquisition and motivation, whilst negative feedback may have the opposite effect. 1  We aimed to examine the impact of targeted trainer feedback based on video analysis on trainee confidence and objective operative performance in laparoscopic cholecystectomy.
METHODS


Selected procedures designated as training cases were recorded. These were assessed by the trainers using the Independence-Scaled Procedural Assessment Score for laparoscopic cholecystectomy. Targeted feedback based on video review of selected procedures was then delivered by the trainers to the trainees. Trainees completed a self-reported questionnaire based on their response to this feedback. Subsequent to the feedback intervention, further training procedures were recorded and assessed.
RESULTS


A total of 6 trainees and 4 trainers participated in the study. For the pre-intervention assessment 15 cases were recorded, with a further 13 for the post-intervention assessment (total n = 28). The overall scores for the procedures performed post video feedback were improved, with a trend towards statistical significance (p = 0.08). However, there was a statistically significant improvement in the scores for performance of the triangle of Calot dissection after the feedback intervention (p = 0.009). The response rate to the questionnaire was 100%, with all trainees agreeing that they felt more confident and competent after the feedback intervention.
CONCLUSION


Targeted feedback to trainees based on post-procedure video review improves trainee confidence and may also improve performance. ACGME Core Competencies; Patient Care and Procedural Skills; Practice Based Learning and Improvement.",2020,"However, there was a statistically significant improvement in the scores for performance of the triangle of Calot dissection after the feedback intervention (p = 0.009).",['A total of 6 trainees and 4 trainers participated in the study'],['laparoscopic cholecystectomy'],"['skill acquisition and motivation', 'trainee confidence', 'overall scores', 'scores for performance of the triangle of Calot dissection', 'trainee confidence and objective operative performance', 'response rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",6.0,0.0391477,"However, there was a statistically significant improvement in the scores for performance of the triangle of Calot dissection after the feedback intervention (p = 0.009).","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Surgery, Mayo University Hospital, Castlebar, Co. Mayo, Ireland. Electronic address: laurenoconnell@rcsi.ie.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McKevitt', 'Affiliation': 'Department of Surgery, Mayo University Hospital, Castlebar, Co. Mayo, Ireland.'}, {'ForeName': 'Waqar', 'Initials': 'W', 'LastName': 'Khan', 'Affiliation': 'Department of Surgery, Mayo University Hospital, Castlebar, Co. Mayo, Ireland.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Waldron', 'Affiliation': 'Department of Surgery, Mayo University Hospital, Castlebar, Co. Mayo, Ireland.'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Department of Surgery, Mayo University Hospital, Castlebar, Co. Mayo, Ireland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Barry', 'Affiliation': 'Department of Surgery, Mayo University Hospital, Castlebar, Ireland; Discipline of Surgery, National University of Ireland, Galway, Ireland; National Director for Specialty Training in General Surgery, Royal College of Surgeons in Ireland, Dublin, Ireland.'}]",The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland,['10.1016/j.surge.2020.08.011']
2535,32962934,"Intraoperative Remifentanil Infusion and Postoperative Pain Outcomes After Cardiac Surgery-Results from Secondary Analysis of a Randomized, Open-Label Clinical Trial.","DESIGN


Report of secondary pain outcomes from a prospective, randomized, open-label clinical trial that compared remifentanil and fentanyl on perioperative hyperglycemic response in cardiac surgery.
SETTING


Single institution, tertiary university hospital.
PARTICIPANTS


The study comprised 116 adult elective cardiac surgical patients.
INTERVENTIONS


Participants were randomly assigned to receive either intermittent fentanyl boluses (F) or continuous remifentanil infusion (R) intraoperatively.
MEASUREMENTS AND MAIN RESULTS


Postoperative pain was evaluated with pain scores every 6 hours for 48 hours. Pain threshold to mechanical stimuli was measured around the sternotomy incision at 48 and 96 hours. The development of chronic pain was assessed using the numeric rating scale at 1, 3, 6, and 12 months after discharge. The final analysis included 106 patients. Pain scores and wound hyperalgesia were not significantly different postoperatively between the groups. The incidence of chronic pain at 3 months was comparable in both groups (61% in group F v 58% in group R; p = 0.79). Pain of more-than-mild degree was seen in 13 (32%) patients in group F and 8 (19%) in group R (p = 0.25) at 3 months. Median pain scores were not significantly different between the groups at 1, 3, 6, and 12 months after discharge from the hospital.
CONCLUSIONS


The present study's findings suggested that intraoperative remifentanil infusion does not significantly worsen pain outcomes in patients undergoing elective cardiac surgery.",2020,"Median pain scores were not significantly different between the groups at 1, 3, 6, and 12 months after discharge from the hospital.
","['cardiac surgery', '116 adult elective cardiac surgical patients', '106 patients', 'patients undergoing elective cardiac surgery', 'Single institution, tertiary university hospital']","['intraoperative remifentanil infusion', 'remifentanil and fentanyl', 'intermittent fentanyl boluses (F) or continuous remifentanil infusion (R) intraoperatively', 'Intraoperative Remifentanil']","['Pain scores and wound hyperalgesia', 'pain scores', 'chronic pain', 'numeric rating scale', 'pain outcomes', 'incidence of chronic pain', 'Pain', 'Median pain scores', 'perioperative hyperglycemic response', 'Pain threshold to mechanical stimuli', 'Postoperative Pain Outcomes']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",116.0,0.212556,"Median pain scores were not significantly different between the groups at 1, 3, 6, and 12 months after discharge from the hospital.
","[{'ForeName': 'Kathirvel', 'Initials': 'K', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA. Electronic address: subramaniamk@upmc.edu.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ibarra', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Ruppert', 'Affiliation': 'Department of Epidemiology, Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Kushi', 'Initials': 'K', 'LastName': 'Mallikarjun', 'Affiliation': 'St Louis School of Medicine, Washington University, St Louis, MO.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Orebaugh', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.08.064']
2536,32965047,Follow-up of offspring and mothers with gestational diabetes treated with metformin or glibenclamide: A randomized controlled trial.,"A 9-year follow-up of a randomized controlled trial showed metformin to have better neonatal outcomes than glibenclamide. Treatment options for moderate gestational diabetes mellitus include metformin and glibenclamide. A randomized controlled trial[3] performed 9 years ago comparing the use of metformin and glibenclamide showed significantly better neonatal outcomes with the use of metformin. The present study followed up 78 (49%) of 159 women that were randomized, along with their offspring, to compare adiposity, anthropometric measurements, and prevalence of diabetes between the two treatment groups.",2020,"The present study followed up 78 (49%) of 159 women that were randomized, along with their offspring, to compare adiposity, anthropometric measurements, and prevalence of diabetes between the two treatment groups.","['up 78 (49%) of 159 women', 'moderate gestational diabetes mellitus']","['glibenclamide', 'metformin and glibenclamide', 'metformin', 'metformin or glibenclamide']",['neonatal outcomes'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",159.0,0.108702,"The present study followed up 78 (49%) of 159 women that were randomized, along with their offspring, to compare adiposity, anthropometric measurements, and prevalence of diabetes between the two treatment groups.","[{'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Paul', 'Affiliation': 'Department of Pediatrics, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Priyambada', 'Affiliation': 'Department of Pediatrics, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Abraham', 'Affiliation': 'Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Manimegalai', 'Affiliation': 'Department of Dietetics, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Paul', 'Affiliation': 'Department of Endocrinology Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Princy', 'Affiliation': 'Department of Bio-Statistics, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Antonisamy', 'Affiliation': 'Department of Bio-Statistics, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'Department of Endocrinology Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Hilda', 'Initials': 'H', 'LastName': 'Yenuberi', 'Affiliation': 'Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Jiji E', 'Initials': 'JE', 'LastName': 'Mathews', 'Affiliation': 'Department of Obstetrics and Gynecology, Christian Medical College, Vellore, Tamil Nadu, India.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13380']
2537,32965052,Mandibular two-implant overdentures with CAD-CAM milled bars with distal extensions or retentive anchors: a randomized controlled trial.,"OBJECTIVE


This randomized controlled trial (RCT) aimed to demonstrate the noninferiority of mandibular 2-implant overdentures (IODs) on a CAD-CAM milled bar with long distal extensions (MBDE) against IODs on retentive anchors (RA).
METHODS


Forty edentulous participants rehabilitated with a maxillary conventional denture and a mandibular 2-IOD participated in this trial. They were randomized into two groups [Control group (CG): RA + gold matrices; Experimental group (EG): MBDE + gold clip]. The outcomes included implant survival rate (ISR), chewing efficiency [quantitative (VoH) and subjective (SA) assessments], peri-implant marginal bone-levels (PI-MBL), maximum bite-force (MBF), and patient-reported outcomes [oral health impact profile (OHIP-EDENT) and denture satisfaction index (DSI)]. Outcomes were recorded at baseline (BL), two weeks (T 0  ), 6-months (T 1  ) and at 1-year (T 2  ) after the intervention. Intra- and inter-group analyses were performed using regression models with ⍺=0.05.
RESULTS


38 participants completed the T 2  visit (CG: n=19, age=74.7±7.8y; EG: n=19, age=70.3±10.7y). At T 2  , there was no implant loss in either of the groups (ISR=100%). There were no significant differences between the groups for the PI-MBL changes (p=0.754). Improvements occurred faster in the EG than in the CG, but over the observation time, there were no differences between the trial groups for VoH, MBF, OHIP-EDENT, and the DSI, except for SA being significantly better in the EG group (p=0.022).
CONCLUSIONS


The results of this RCT confirm that mandibular 2-IODs with a CAD-CAM milled bar with long distal extensions are not an inferior treatment to the conventional IODs on retentive anchors in the short term (1-year).",2020,There were no significant differences between the groups for the PI-MBL changes (p=0.754).,"['38 participants completed the T 2  visit (CG: n=19, age=74.7±7.8y; EG: n=19, age=70.3±10.7y', 'Forty edentulous participants rehabilitated with a maxillary conventional denture and a mandibular 2-IOD participated in this trial']","['CAD-CAM milled bar with long distal extensions (MBDE', 'Control group (CG): RA + gold matrices; Experimental group (EG): MBDE + gold clip', 'CAD-CAM milled bars with distal extensions or retentive anchors', 'mandibular 2-implant overdentures (IODs']","['implant survival rate (ISR), chewing efficiency [quantitative (VoH) and subjective (SA) assessments], peri-implant marginal bone-levels (PI-MBL), maximum bite-force (MBF), and patient-reported outcomes [oral health impact profile (OHIP-EDENT) and denture satisfaction index (DSI', 'implant loss', 'PI-MBL changes']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0457285', 'cui_str': 'Conventional denture'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0162514', 'cui_str': 'CAD-CAM'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",40.0,0.157746,There were no significant differences between the groups for the PI-MBL changes (p=0.754).,"[{'ForeName': 'Murali', 'Initials': 'M', 'LastName': 'Srinivasan', 'Affiliation': 'Center of General-, Special care-, & Geriatric dentistry, Center of Dental Medicine, University of Zurich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schimmel', 'Affiliation': 'Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine, University of Geneva, Switzerland.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Buser', 'Affiliation': 'Department of Reconstructive Dentistry and Gerodontology, School of Dental Medicine, University of Bern, Switzerland, Bern.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Maniewicz', 'Affiliation': 'Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine, University of Geneva, Switzerland.'}, {'ForeName': 'François R', 'Initials': 'FR', 'LastName': 'Herrmann', 'Affiliation': 'Division of Geriatrics, Dept. of Rehabilitation and Geriatics, Geneva University Hospitals, Trois-Chêne, Geneva, Switzerland.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine, University of Geneva, Switzerland.'}]",Clinical oral implants research,['10.1111/clr.13668']
2538,32965057,"Protocol for a single patient therapy plan: A randomised, double-blind, placebo-controlled N-of-1 trial to assess the efficacy of cannabidiol in patients with intractable epilepsy.","AIM


This paper describes the use of the single patient therapy plan (SPTP). The SPTP has been designed to assess the efficacy at an individual level of a commercially available cannabinoid product, cannabidiol, in reducing seizure frequency in paediatric patients with intractable epilepsy.
METHODS


The SPTP is a randomised, double-blind, placebo-controlled N-of-1 trial designed to assess the efficacy of treatment in a neurology outpatient setting. The primary objective of the SPTP is to assess the efficacy of cannabidiol in reducing seizure frequency in each patient with intractable epilepsy, with change in seizure frequency being the primary outcome of interest. The analysis adopts a Bayesian approach, which provides results in the form of posterior probabilities that various levels of benefit (based on the primary outcome measure, seizure frequency) have been achieved under active treatment compared to placebo, accompanied by decision rules that provide thresholds for deciding whether treatment has been successful in the individual patient. The SPTP arrangement is most accurately considered part of clinical practice rather than research, since it is aimed at making clinical treatment decisions for individual patients and is not testing a hypothesis or collecting aggregate data. Therefore, Human Research Ethics Committee approval was considered not to be required, although it is recommended that hospital Clinical Ethics Committees provide ethical oversight.
CONCLUSION


These SPTP resources are made available so that they may inform clinical practice in the treatment of severe epilepsy or adapted for use in other conditions.",2020,"The SPTP is a randomised, double-blind, placebo-controlled N-of-1 trial designed to assess the efficacy of treatment in a neurology outpatient setting.","['paediatric patients with intractable epilepsy', 'patients with intractable epilepsy']","['placebo', 'SPTP']",['seizure frequency'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0149775', 'cui_str': 'Fit frequency'}]",,0.40951,"The SPTP is a randomised, double-blind, placebo-controlled N-of-1 trial designed to assess the efficacy of treatment in a neurology outpatient setting.","[{'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Ong', 'Affiliation': 'Victoria Department of Health and Human Services, Melbourne, Victoria, Australia.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Carlin', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fahey', 'Affiliation': ""Monash Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Freeman', 'Affiliation': ""Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Scheffer', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Gillam', 'Affiliation': 'The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Neuroscience Trials Australia, Melbourne, Victoria, Australia.'}, {'ForeName': 'Md Hamidul', 'Initials': 'MH', 'LastName': 'Huque', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Legge', 'Affiliation': ""Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Dirnbauer', 'Affiliation': ""Monash Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lilley', 'Affiliation': ""Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Slota-Kan', 'Affiliation': 'Victoria Department of Health and Human Services, Melbourne, Victoria, Australia.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Cranswick', 'Affiliation': ""Royal Children's Hospital, Melbourne, Victoria, Australia.""}]",Journal of paediatrics and child health,['10.1111/jpc.15078']
2539,32965075,"Efficacy and safety of polyethylene glycol loxenatide (PEX168) monotherapy in type 2 diabetes patients: a multicenter, randomized, double-blind, placebo-controlled, phase 3a clinical trial.","AIM


To evaluate the efficacy and safety of PEX168 monotherapy in type 2 diabetes (T2DM) patients in China.
MATERIALS AND METHODS


In a multicentered, randomized, double-blinded placebo-controlled phase 3a clinical trial, 361 patients with inadequate glycemic control (HbA1c, 7.0-10.5%; fasting plasma glucose, <13.9 mmol/L) were randomized (1:1:1) for weekly subcutaneous injections: placebo, PEX168/100 μg, or PEX168/200 μg. The 24-week treatment was followed by a 28-week extension, during which placebo-treated patients were randomly assigned to PEX168/100 μg or PEX168/200 μg. The primary efficacy endpoint was the HbA1c change from baseline to week 24.
RESULTS


The three groups had similar demographics and baseline characteristics. The HbA1c least-square mean [LSM (95% CI)] change from baseline to week 24 was greater for PEX168/100 μg [-1.02% (-1.21, -0.83)] and PEX168/200 μg [-1.34% (-1.54, -1.15)] than for placebo [-0.17% (-0.36, 0.02)]; (superiority: p < 0.0001). The proportions of patients with <7% HbA1c in the placebo, PEX168/100 μg, and PEX168/200 μg groups were 15.7%, 34.7%, and 46.6%, respectively. Common gastrointestinal adverse events (AEs) were nausea (5.6%, 10.0%, and 0% for PEX168/100 μg, PEX168/200 μg, and placebo, respectively) and vomiting (2.4%, 8.3%, and 0% for PEX168/100 μg, PEX168/200 μg, and placebo, respectively). Six (1.6%) patients [PEX168/100 μg: N = 2 (1.6%), PEX168/200 μg: N = 3 (2.5%), and placebo: N = 1 (0.8%)] discontinued treatment due to AEs. Four (1.2%) patients [PEX168/100 μg: N = 3 (2.5%), and PEX168/200 μg: N = 1 (0.9%)] developed PEX168 anti-drug antibodies.
CONCLUSION


PEX168 monotherapy significantly improved glycemic control in T2DM patients with a safety profile resembling that of other GLP-1 receptor agonists. This article is protected by copyright. All rights reserved.",2020,"Common gastrointestinal adverse events (AEs) were nausea (5.6%, 10.0%, and 0% for PEX168/100 μg, PEX168/200 μg, and placebo, respectively) and vomiting (2.4%, 8.3%, and 0% for PEX168/100 μg, PEX168/200 μg, and placebo, respectively).","['361 patients with inadequate glycemic control (HbA1c, 7.0-10.5%; fasting plasma glucose, <13.9\u2009mmol/L', 'μg', 'type 2 diabetes (T2DM) patients in China', '2 diabetes patients']","['subcutaneous injections: placebo, PEX168/100\u2009μg, or PEX168/200\u2009μg', 'PEX168 monotherapy', 'polyethylene glycol loxenatide (PEX168', 'placebo-treated patients were randomly assigned to PEX168/100\u2009μg or PEX168/200\u2009μg', 'placebo', 'monotherapy']","['efficacy and safety', 'nausea', 'Efficacy and safety', 'vomiting', 'HbA1c change', 'glycemic control', 'HbA1c least-square mean [LSM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4079755', 'cui_str': 'PEX168'}, {'cui': 'C4077947', 'cui_str': 'polyethylene glycol loxenatide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",361.0,0.663396,"Common gastrointestinal adverse events (AEs) were nausea (5.6%, 10.0%, and 0% for PEX168/100 μg, PEX168/200 μg, and placebo, respectively) and vomiting (2.4%, 8.3%, and 0% for PEX168/100 μg, PEX168/200 μg, and placebo, respectively).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shuai', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Gangyi', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'The Center of Clinical Research of Endocrinology and Metabolic Diseases in Chongqing and Department of Endocrinology, Chongqing Three Gorges Central Hospital, Chongqing, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Nanjing First Hospital, Nanjing, China.'}, {'ForeName': 'Daoxiong', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Endocrinology, People's Hospital of Hainan, Haikou, China.""}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, Central Hospital of Minhang District, Minhang Hospital affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The First Affiliated Hospital of Hainan Medical University, Haikou, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology Medicine, Lianyungang First People's Hospital, Affiliated Hospital of Xuzhou Medical College, Lianyungang, China.""}, {'ForeName': 'Wenying', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14198']
2540,32965143,Merging Yoga and Occupational Therapy for Parkinson's Disease: A Feasibility and Pilot Program.,"The purpose of this study was to assess feasibility and changes in outcome measures following the Merging Yoga and Occupational Therapy for Parkinson's Disease (MY-OT for PD) program: a 14-session program which combined community-based yoga for PD, and fall-risk focused group occupational therapy sessions. Seventeen participants completed an 8-week control period consisting of their normal participation, and an 8-week intervention period (14 MY-OT for PD sessions). There were fewer self-reported falls in the intervention (6) vs. control periods (10). One fall risk factor management scale (the Fall Prevention and Management Questionnaire, p=.02), and balance (p<.01) showed significant improvement between the control and intervention. The MY-OT for PD program is an encouraging occupational therapist-led program, which may improve balance and reduce self-reported falls.",2020,"One fall risk factor management scale (the Fall Prevention and Management Questionnaire, p=.02), and balance (p<.01) showed significant improvement between the control and intervention.","[""Parkinson's Disease"", 'Seventeen participants']",['Merging Yoga and Occupational Therapy'],['fall risk factor management scale'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0450331', 'cui_str': '17'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",17.0,0.0108235,"One fall risk factor management scale (the Fall Prevention and Management Questionnaire, p=.02), and balance (p<.01) showed significant improvement between the control and intervention.","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Swink', 'Affiliation': 'Eastern Colorado VA Geriatric Research Education and Clinical Center (GRECC), Aurora, CO, USA.'}, {'ForeName': 'Brett W', 'Initials': 'BW', 'LastName': 'Fling', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Sharp', 'Affiliation': 'Department of Statistics, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Fruhauf', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Atler', 'Affiliation': 'Department of Occupational Therapy, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Arlene A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Department of Occupational Therapy, Colorado State University, Fort Collins, CO, USA.'}]",Occupational therapy in health care,['10.1080/07380577.2020.1824302']
2541,32965160,VESTIBULAR MODULATION OF SKIN SYMPATHETIC NERVE ACTIVITY IN SOPITE SYNDROME INDUCED BY LOW-FREQUENCY SINUSOIDAL MOTION.,"Sopite syndrome, centred around the drowsiness, lethargy and irritability associated with motion sickness, can be induced by exposure to low-frequency motion. It is known that the vestibular apparatus plays an important role in the pathogenesis of motion sickness, which features several autonomic responses, and we have previously documented increased vestibular modulation of skin sympathetic nerve activity (SSNA) and an increase in skin blood flow associated with nausea. Here we assessed whether imperceptibly slow sinusoidal motion, sufficient to induce sopite syndrome but not nausea, also modulates SSNA and skin blood flow. Participants were seated upright and exposed to a randomised set of sinusoidal linear accelerations, ranging from 0.03 Hz at 0.5 mG to 0.2 Hz at 5 mG, via a motorised platform. At all frequencies vestibular modulation was greater than the cardiac modulation of SSNA, but cardiac modulation and skin blood flow were both significantly lower during the motion than at baseline. We conclude that sopite syndrome is associated with a marked modulation of sympathetic outflow to the skin and cutaneous vasoconstriction.",2020,"At all frequencies vestibular modulation was greater than the cardiac modulation of SSNA, but cardiac modulation and skin blood flow were both significantly lower during the motion than at baseline.",[],[],['cardiac modulation and skin blood flow'],[],[],"[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.0167152,"At all frequencies vestibular modulation was greater than the cardiac modulation of SSNA, but cardiac modulation and skin blood flow were both significantly lower during the motion than at baseline.","[{'ForeName': 'Monique R', 'Initials': 'MR', 'LastName': 'Foster', 'Affiliation': 'School of Medicine, Western Sydney University, Australia.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'School of Medicine, Western Sydney University, Australia.'}, {'ForeName': 'Kenny C S', 'Initials': 'KCS', 'LastName': 'Kwok', 'Affiliation': 'School of Civil Engineering, University of Sydney, Australia.'}, {'ForeName': 'Vaughan G', 'Initials': 'VG', 'LastName': 'Macefield', 'Affiliation': 'Human Autonomic Neurophysiology, Baker IDI Heart and Diabetes Institute, Australia.'}]",Journal of neurophysiology,['10.1152/jn.00177.2020']
2542,32965223,The Impact of Previsit Contextual Data Collection on Patient-Provider Communication and Patient Activation: Study Protocol for a Randomized Controlled Trial.,"BACKGROUND


Patient-centered care is respectful of and responsive to individual patient preferences, needs, and values. To provide patient-centered care, clinicians need to know and incorporate patients' context into their communication and care with patients. Patient contextual data (PCD) encompass social determinants of health and patients' needs, values, goals, and preferences relevant to their care. PCD can be challenging to collect as a routine component of the time-limited primary care visit.
OBJECTIVE


This study aims to determine if patient-provider communication and patient activation are different for patient users and patient nonusers of an electronic health record (EHR)-integrated PCD tool and assess if the impact of using PCD on patient-provider communication and patient activation differs for Black and White patients.
METHODS


We describe a randomized controlled trial of a prospective cohort of non-Hispanic White and Black patients who receive primary care services at a midwestern academic health care system in the United States. We will evaluate whether providing PCD through a consumer informatics tool enhances patient-provider communication, as measured by the Communication Assessment Tool, and we will evaluate patient activation, as measured by the Patient Activation Measure for PCD tool users and nonusers. Furthermore, owing to racial disparities in care and communication, we seek to determine if the adoption and use of the tool might narrow the differences between patient groups.
RESULTS


The trial was funded in November 2017 and received local ethics review approval in February 2019. The study began recruitment in April 2019 and enrollment concluded in October 2019 with 301 participants. The analysis was completed in May 2020, and trial results are expected to be published in winter 2020.
CONCLUSIONS


Recently, there has been increased attention to the role of health information technology tools to enable patients to collaborate with providers through the sharing of PCD. The adoption of such tools may overcome the barriers of current EHRs by directly engaging patients to submit their contextual data. Effectively, these tools would support the EHR in providing a more holistic understanding of the patient. Research further supports that individuals who have robust digital engagement using consumer informatics tools have higher participation in treatment follow-up and self-care across populations. Therefore, it is critical to investigate interventions that elicit and share patients' social risks and care preferences with the health care team as a mechanism to improve individualized care and reduce the gap in health outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03766841; https://clinicaltrials.gov/ct2/show/NCT03766841.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/20309.",2020,Research further supports that individuals who have robust digital engagement using consumer informatics tools have higher participation in treatment follow-up and self-care across populations.,"['patient users and patient nonusers of an', 'Black and White patients', 'non-Hispanic White and Black patients who receive primary care services at a midwestern academic health care system in the United States', 'April 2019 and enrollment concluded in October 2019 with 301 participants']","['electronic health record (EHR)-integrated PCD tool', 'PCD', 'Previsit Contextual Data Collection']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}]","[{'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]",[],,0.102701,Research further supports that individuals who have robust digital engagement using consumer informatics tools have higher participation in treatment follow-up and self-care across populations.,"[{'ForeName': 'Jeana M', 'Initials': 'JM', 'LastName': 'Holt', 'Affiliation': 'College of Nursing, University of Wisconsin-Milwaukee, Milwaukee, WI, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Cusatis', 'Affiliation': 'Hematology and Oncology Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Winn', 'Affiliation': 'School of Pharmacy, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Asan', 'Affiliation': 'School of Systems and Enterprises, Stevens Institute of Technology, Hoboken, NJ, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Spanbauer', 'Affiliation': 'Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Joni S', 'Initials': 'JS', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Center for Advancing Population Science, Milwaukee, WI, United States.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Flynn', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Melek', 'Initials': 'M', 'LastName': 'Somai', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Purushottam', 'Initials': 'P', 'LastName': 'Laud', 'Affiliation': 'Institute for Health and Equity, Medical College of Wisconsin, Milwaukee, WI, United States.'}, {'ForeName': 'Bradley H', 'Initials': 'BH', 'LastName': 'Crotty', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, United States.'}]",JMIR research protocols,['10.2196/20309']
2543,32965224,SMS Text Messages for Parents for the Prevention of Child Drowning in Bangladesh: Acceptability Study.,"BACKGROUND


In many cases, greater use is being made of mobile phone text messages as a means of communication between patients and health care providers in countries around the world.
OBJECTIVE


We studied the use of mobile phones and the factors related to the acceptability of text messages for parents for the prevention of child drowning in Bangladesh.
METHODS


From a randomized controlled trial involving 800 parents, 10% (80/800) were selected, and socioeconomic status, mobile phone use, and acceptability of SMS text messages for drowning prevention were measured. Participants with at least one child under 5 years of age were selected from rural areas in Rajshahi District in Bangladesh. Mobile phone-based SMS text messages were sent to the participants. Multivariate regression was used to determine the factors related to the acceptability of text messages for the prevention of child drowning in Bangladesh.
RESULTS


The acceptability of SMS text messages for the prevention of child drowning in Bangladesh was significantly lower among women (odds ratio [OR] 0.50, 95% CI 0.12-1.96, P=.02) than among men, lower for parents older than 30 years (OR 0.17, 95% CI 0.14-1.70, P=.01) compared to parents younger than 30 years, higher among parents who had an education (OR 1.63, 95% CI 1.11-5.80, P=.04) than among illiterate parents, and higher among parents with a monthly household income over 7000 Bangladeshi Taka (approximately US $82.54; OR 1.27, 95% CI 1.06-1.96, P=.05) than among parents whose monthly income was less than 7000 Bangladeshi Taka.
CONCLUSIONS


The high percentage of mobile phone use and the acceptability of SMS text messages for parents for the prevention of child drowning are encouraging, in terms of identifying the best strategy for using such technologies, and deserve further evaluation.",2020,"Multivariate regression was used to determine the factors related to the acceptability of text messages for the prevention of child drowning in Bangladesh.
","['Parents for the Prevention of Child Drowning in Bangladesh', '800 parents, 10% (80/800) were selected, and socioeconomic status, mobile phone use, and acceptability of SMS text messages for drowning prevention were measured', 'parents for the prevention of child drowning in Bangladesh', 'patients and health care providers in countries around the world', 'Participants with at least one child under 5 years of age were selected from rural areas in Rajshahi District in Bangladesh']",[],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0013142', 'cui_str': 'Drowning'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C4505320', 'cui_str': 'Mobile Phone Use'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",[],[],800.0,0.136981,"Multivariate regression was used to determine the factors related to the acceptability of text messages for the prevention of child drowning in Bangladesh.
","[{'ForeName': 'Md Mosharaf', 'Initials': 'MM', 'LastName': 'Hossain', 'Affiliation': 'Faculty of Business, Economics and Social Development, Universiti Malaysia Terengganu, Kuala Nerus, Terengganu, Malaysia.'}, {'ForeName': 'Kulanthayan', 'Initials': 'K', 'LastName': 'Mani', 'Affiliation': 'Safe Kids Malaysia and Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Ruhani', 'Initials': 'R', 'LastName': 'Mat Min', 'Affiliation': 'Faculty of Business, Economics and Social Development, Universiti Malaysia Terengganu, Kuala Nerus, Terengganu, Malaysia.'}]",JMIR mHealth and uHealth,['10.2196/16958']
2544,32965238,School-Based Multicomponent Intervention to Promote Physical Activity and Reduce Sedentary Time of Disadvantaged Children Aged 6-10 Years: Protocol for a Randomized Controlled Trial.,"BACKGROUND


In our modern society, physical activity (PA) is decreasing and sedentary time (ST) is increasing, especially for children from disadvantaged neighborhoods. School-based interventions to promote PA and decrease ST are therefore required among this population in order to change children's lifestyle habits. Moreover, attentional capacities and academic achievement can be enhanced by chronic PA during childhood. The relationships between these variables have been poorly studied with this population.
OBJECTIVE


The objective of this study is to present the rationale and methods for a randomized controlled trial among 6-10-year-old children with low socioeconomic status that will (1) evaluate the effectiveness of a school-based intervention designed to promote PA and reduce ST and (2) study the relationships between PA, ST, motor skills, attentional capacities, and academic achievement.
METHODS


A randomized controlled trial was conducted in 2 eligible primary schools. During academic year 2016-2017, 1 school was randomly assigned as the experiment one and the other was assigned as the control one. Five assessments times were used: baseline (T1 [November 2016] to T2 [June 2017]), follow-up (T3 [November 2017] to T4 [June 2018]), and final assessment (T5 [June 2019]). The school-based intervention included various components on different levels of the socioecological model: (1) curriculum-based program for children; (2) sensitization workshops and newsletters for parents; (3) training workshops for teachers; (4) environmental adaptation of playgrounds and reorganization of recess time; (5) time adaptation of lunch breaks; and (6) collaboration with political groups. PA, ST, motor skills, and attentional capacities were evaluated and academic achievement was recorded.
RESULTS


The presented intervention and its different assessments have been successfully implemented. In order to achieve the 2 objectives of this randomized controlled trial, data analyses are about to be completed.
CONCLUSIONS


The implementation of this randomized controlled trial can help to determine effective strategies to promote PA in the context of increasing prevalence of physical inactivity among children with sedentary lifestyle which will be useful for researchers, stakeholders, and public policy makers.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03983447; https://clinicaltrials.gov/ct2/show/NCT03983447.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/17815.",2020,School-based interventions to promote PA and decrease ST are therefore required among this population in order to change children's lifestyle habits.,"['children with sedentary lifestyle', '6-10-year-old children with low socioeconomic status that will (1', 'children from disadvantaged neighborhoods', '2 eligible primary schools', 'Aged 6-10 Years', 'During academic year 2016-2017, 1 school', 'Disadvantaged Children']","['School-Based Multicomponent Intervention', 'socioecological model: (1) curriculum-based program for children; (2) sensitization workshops and newsletters for parents; (3) training workshops for teachers; (4) environmental adaptation of playgrounds and reorganization of recess time; (5) time adaptation of lunch breaks; and (6) collaboration with political groups']","['PA, ST, motor skills, attentional capacities, and academic achievement', 'attentional capacities and academic achievement', 'PA, ST, motor skills, and attentional capacities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0178620', 'cui_str': 'Environmental adaptation'}, {'cui': 'C0442596', 'cui_str': 'School playground'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]",2.0,0.106121,School-based interventions to promote PA and decrease ST are therefore required among this population in order to change children's lifestyle habits.,"[{'ForeName': 'Caroline Maite Marie', 'Initials': 'CMM', 'LastName': 'Bernal', 'Affiliation': ""Universite de Pau & des Pays de l'Adour, e2s UPPA, MEPS, Tarbes, France.""}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Lhuisset', 'Affiliation': ""Universite de Pau & des Pays de l'Adour, e2s UPPA, MEPS, Tarbes, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Fabre', 'Affiliation': ""Universite de Pau & des Pays de l'Adour, e2s UPPA, MEPS, Tarbes, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Bois', 'Affiliation': ""Universite de Pau & des Pays de l'Adour, e2s UPPA, MEPS, Tarbes, France.""}]",JMIR research protocols,['10.2196/17815']
2545,32965277,"Efficacy and Safety of Switching to Dolutegravir With Boosted Darunavir in Virologically Suppressed Adults With HIV-1: A Randomized, Open-Label, Multicenter, Phase 3, Noninferiority Trial: The DUALIS Study.","Background


Dolutegravir (DTG) and boosted darunavir (bDRV) are potent antiretrovirals with a high resistance barrier and might be valuable switch options for people with HIV (PWH).
Methods


DUALIS, a randomized, open-label, phase 3b, noninferiority clinical trial, compared the switch to DTG + bDRV (2DR) with continuation of 2 nucleoside reverse transcriptase inhibitors (2NRTI) + bDRV (3DR). PWH with HIV RNA <50 copies/mL taking 2NRTI + bDRV (3DR) for ≥24 weeks (1 accepted blip <200 copies/mL) were randomized to either switch to DTG 50 mg + DRV 800 mg (boosted with 100 mg of ritonavir) or continue taking 3DR. The primary end point (PE) was the proportion of HIV RNA <50 copies/mL at week (W) 48. Change in NRTI backbone was not classified as failure. The estimated sample size for PE analysis was 292; the noninferiority margin was ≤-10.0%.
Results


In total, 263 subjects were randomized and treated (2DR n = 131, 3DR n = 132; 90.1% male; 89.7% Caucasian; median age [interquartile range], 48 [39-54] years). At W48, 86.3% (n = 113/131) of the 2DR subject and 87.9% (n = 116/132) of the 3DR subjects had HIV RNA <50 copies/mL; the difference between arms was -1.6% (95.48% CI, based on the adjusted alpha level accounting for the interim analysis at W24, -9.9% to +6.7%; discontinuations due to adverse events: 2DR, 4.6% [n = 6]; 3DR, 0.8% [n = 1]). Kaplan-Meier estimates of confirmed HIV RNA ≥50 copies/mL at W48 were 1.6% (n = 2) in the 2DR and 3.1% (n = 4) in the 3DR group. Development of treatment-emergent resistance was not observed.
Conclusions


Switching to DTG + bDRV was noninferior to continuing 3DR in subjects already treated with bDRV.",2020,"At W48, 86.3% (n = 113/131) of the 2DR subject and 87.9% (n = 116/132) of the 3DR subjects had HIV RNA <50 copies/mL; the difference between arms was -1.6% (95.48% CI, based on the adjusted alpha level accounting for the interim analysis at W24, -9.9% to +6.7%; discontinuations due to adverse events: 2DR, 4.6% [n = 6]; 3DR, 0.8% [n = 1]).","['people with HIV (PWH', 'Virologically Suppressed Adults', '263 subjects were randomized and treated (2DR n\u2005=\u2005131, 3DR n\u2005=\u2005132; 90.1% male; 89.7% Caucasian; median age [interquartile range], 48 [39-54] years']","['\n\n\nDolutegravir (DTG) and boosted darunavir (bDRV', 'DTG 50 mg\u2005+\u2005DRV 800 mg (boosted with 100 mg of ritonavir', 'HIV-1', 'DTG\u2005+\u2005bDRV (2DR) with continuation of 2 nucleoside reverse transcriptase inhibitors (2NRTI)\u2005+\u2005bDRV (3DR']",['Efficacy and Safety'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",263.0,0.251797,"At W48, 86.3% (n = 113/131) of the 2DR subject and 87.9% (n = 116/132) of the 3DR subjects had HIV RNA <50 copies/mL; the difference between arms was -1.6% (95.48% CI, based on the adjusted alpha level accounting for the interim analysis at W24, -9.9% to +6.7%; discontinuations due to adverse events: 2DR, 4.6% [n = 6]; 3DR, 0.8% [n = 1]).","[{'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': 'Technical University of Munich, School of Medicine, University Hospital Rechts der Isar, Munich, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Kümmerle', 'Affiliation': 'Private Practice, Ebertplatz, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Technical University of Munich, School of Medicine, University Hospital Rechts der Isar, Munich, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Cordes', 'Affiliation': 'Private Practice, Berlin, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Heiken', 'Affiliation': 'Private Practice, Georgstrasse, Hannover, Germany.'}, {'ForeName': 'Hans-Jürgen', 'Initials': 'HJ', 'LastName': 'Stellbrink', 'Affiliation': 'ICH Study Center, Hamburg, Germany.'}, {'ForeName': 'Ivanka', 'Initials': 'I', 'LastName': 'Krznaric', 'Affiliation': 'Private Practice, Zentrum für Infektiologie Prenzlauer Berg, Berlin, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Scholten', 'Affiliation': 'Private Practice, Hohenstaufenring, Köln, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Jensen', 'Affiliation': 'University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wyen', 'Affiliation': 'Private Practice, Ebertplatz, Germany.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Viehweger', 'Affiliation': 'Private Practice, Berlin, Germany.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Lehmann', 'Affiliation': 'Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sprinzl', 'Affiliation': 'Department of Medicine I, University Hospital Mainz, Mainz, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Stoehr', 'Affiliation': 'Private Practice, IfI Institute, Hamburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bickel', 'Affiliation': 'Private Practice, Infektiologiukum, Frankfurt, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Jessen', 'Affiliation': 'Private Practice, Jessen2, Berlin, Germany.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Obst', 'Affiliation': 'Department of Gastroenterology, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Spornraft-Ragaller', 'Affiliation': 'University Hospital Dresden, Fetscherstr, Germany.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Khaykin', 'Affiliation': 'Private Practice, MainFachArzt, Frankfurt, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wolf', 'Affiliation': 'MUC Research Clinical Research Organization (CRO), Munich, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Boesecke', 'Affiliation': 'Bonn University Hospital, Bonn, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Open forum infectious diseases,['10.1093/ofid/ofaa356']
2546,32965318,Knowledge and attitude of candidates to gastroplasty about perioperative: randomized clinical trial.,"OBJECTIVES


to evaluate the effectiveness of educational intervention in the knowledge and attitude of candidates for gastroplasty.
METHODS


randomized controlled clinical trial with 56 preoperative patients (intervention=28; control=28). The control group received routine care from the health institution and the intervention group participated in a book-mediated educational intervention. Forms were used for clinical-epidemiological characterization and evaluation of knowledge/attitude about bariatric surgery, which were reapplied seven weeks after intervention. RBR-297fzx.
RESULTS


in the pre-test there was no significant difference between the groups (p=0.254). In the post-test, the group that received verbal guidance had a mean score of 19.5 (± 6.17) and the group reading the booklet averaged 31.1 (± 2.96), p=0.000. The attitude is adequate, especially for care such as vitamin supplement intake, water intake and physical activity practice.
CONCLUSIONS


the educational intervention mediated by booklet was effective in improving knowledge and attitude when compared to verbal guidance. Thus, it can be replicated during the preoperative preparation.",2020,the pre-test there was no significant difference between the groups (p=0.254).,['56 preoperative patients (intervention=28; control=28'],"['RBR-297fzx', 'routine care from the health institution and the intervention group participated in a book-mediated educational intervention', 'educational intervention', 'verbal guidance']",['knowledge and attitude'],"[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",56.0,0.05918,the pre-test there was no significant difference between the groups (p=0.254).,"[{'ForeName': 'Lívia Moreira', 'Initials': 'LM', 'LastName': 'Barros', 'Affiliation': 'Universidade da Integração Internacional da Lusofonia Afro-Brazileira. Redenção, Ceará, Brazil.'}, {'ForeName': 'Francisca Antônia do Vale', 'Initials': 'FADV', 'LastName': 'Gomes', 'Affiliation': 'Universidade Federal do Ceará. Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Flávio Neves', 'Initials': 'FN', 'LastName': 'Carneiro', 'Affiliation': 'Universidade Federal do Ceará. Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Nelson Miguel', 'Initials': 'NM', 'LastName': 'Galindo Neto', 'Affiliation': 'Instituto Federal de Pernambuco. Pesqueira, Pernambuco, Brazil.'}, {'ForeName': 'Natasha Marques', 'Initials': 'NM', 'LastName': 'Frota', 'Affiliation': 'Universidade da Integração Internacional da Lusofonia Afro-Brazileira. Redenção, Ceará, Brazil.'}, {'ForeName': 'Joselany Áfio', 'Initials': 'JÁ', 'LastName': 'Caetano', 'Affiliation': 'Universidade Federal do Ceará. Fortaleza, Ceará, Brazil.'}]",Revista brasileira de enfermagem,['10.1590/0034-7167-2018-0869']
2547,32965361,Neutrophil count to albumin ratio as a new predictor of mortality in patients with COVID-19 ınfection.,"BACKGROUND


Coronavirus Disease 2019 is an acute inflammatory respiratory disease. It causes many changes in hemogram parameters. Low albumin levels are associated with mortality risk in hospitalized patients. The aim of the present study is to reveal the place of neutrophil count to albumin ratio in predicting mortality in patients with COVID-19.
METHODS


144 patients, 65 females and 79 males, were included in the study. Patients were divided into 2 groups. Group 1 was the non-severe group (n:85), and Group 2 was severe (n:59). Demographic data, neutrophil, lymphocyte and platelet counts, albumin and C-reactive protein (CRP) levels were recorded. Neutrophil count to albumin ratio (NAR) was calculated by dividing the absolute neutrophil counts by the albumin levels. The NAR and levels of the two groups were then compared.
RESULTS


There were no significant differences in gender and platelet count (201 vs. 211 K/mL) between the groups (p>0,05). Ages (62.0 ± 14.3 vs 68.6 ± 12.2 years), albumin (33.1 vs 29.9 gr/L), CRP (33 vs 113 mg/l), neutrophil count (4 vs 7.24 K/mL), WBC counts (6.70 vs 8.50 K/mL), NAR values (113.5 vs 267.2) and number of Death (5 vs 33) were found to be statistically higher (p <0.001) in Group 2 than in Group 1. The NAR value of 201.5 showed mortality in all patients with COVID-19 to have 71.1% sensitivity and 71.7% specificity (AUC:0.736, 95% CI: 0.641-0.832, p<0.001).
CONCLUSION


The present study showed that NAR levels can be a cheap and simple marker for predicting mortality in patients with COVID-19.",2020,"There were no significant differences in gender and platelet count (201 vs. 211 K/mL) between the groups (p>0,05).","['hospitalized patients', 'patients with COVID-19', 'patients with COVID-19 ınfection', '144 patients, 65 females and 79 males, were included in the study']",[],"['NAR values', 'neutrophil count', 'number of Death', 'WBC counts ', 'Demographic data, neutrophil, lymphocyte and platelet counts, albumin and C-reactive protein (CRP) levels', 'Neutrophil count to albumin ratio', 'Low albumin levels', 'gender and platelet count', 'Neutrophil count to albumin ratio (NAR']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C1532109', 'cui_str': 'Ratio value'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0860864', 'cui_str': 'Decreased albumin'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]",,0.0349063,"There were no significant differences in gender and platelet count (201 vs. 211 K/mL) between the groups (p>0,05).","[{'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Varim', 'Affiliation': '. Associate Professor, Department of Internal Medicine, Sakarya University Medicine Faculty, Sakarya, Turkey.'}, {'ForeName': 'Selcuk', 'Initials': 'S', 'LastName': 'Yaylaci', 'Affiliation': '. Associate Professor, Department of Internal Medicine, Sakarya University Medicine Faculty, Sakarya, Turkey.'}, {'ForeName': 'Taner', 'Initials': 'T', 'LastName': 'Demirci', 'Affiliation': '. Associate Professor, Department of Internal Medicine, Sakarya University Medicine Faculty, Sakarya, Turkey.'}, {'ForeName': 'Tezcan', 'Initials': 'T', 'LastName': 'Kaya', 'Affiliation': '. Associate Professor, Department of Internal Medicine, Sakarya University Medicine Faculty, Sakarya, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Nalbant', 'Affiliation': '. Associate Professor, Department of Internal Medicine, Sakarya University Medicine Faculty, Sakarya, Turkey.'}, {'ForeName': 'Hamad', 'Initials': 'H', 'LastName': 'Dheir', 'Affiliation': '. Associate Professor, Department of Internal Medicine Division of Nephrology, Sakarya University Medicine Faculty, Sakarya, Turkey.'}, {'ForeName': 'Didar', 'Initials': 'D', 'LastName': 'Senocak', 'Affiliation': '. Associate Professor, Department of Internal Medicine, Sakarya University Medicine Faculty, Sakarya, Turkey.'}, {'ForeName': 'Rumeysa', 'Initials': 'R', 'LastName': 'Kurt', 'Affiliation': '. Medical Doctor, Department of Internal Medicine, Sakarya University Medicine Faculty, Sakarya, Turkey.'}, {'ForeName': 'Hasret', 'Initials': 'H', 'LastName': 'Cengiz', 'Affiliation': '. Hasret Cengiz, Medical Doctor, Department of Endocrinology, Sakarya University Medicine Faculty, Sakarya, Turkey.'}, {'ForeName': 'Cengiz', 'Initials': 'C', 'LastName': 'Karacaer', 'Affiliation': '. Hasret Cengiz, Medical Doctor, Department of Endocrinology, Sakarya University Medicine Faculty, Sakarya, Turkey.'}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.S2.77']
2548,32965395,"Rationale and design of the ""Tocilizumab in patients with moderate to severe COVID-19: an open-label multicentre randomized controlled"" trial (TOCIBRAS).","INTRODUCTION


Pro-inflammatory markers play a significant role in the disease severity of patients with COVID-19. Thus, anti-inflammatory therapies are attractive agents for potentially combating the uncontrolled inflammatory cascade in these patients. We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
METHODS AND ANALYSIS


This open-label multicentre randomized controlled trial will compare clinical outcomes of tocilizumab plus standard of care versus standard of care alone in patients with moderate to severe COVID-19. Two of the following four criteria are required for protocol enrolment: D-dimer > 1,000ng/mL; C reactive protein > 5mg/dL, ferritin > 300mg/dL, and lactate dehydrogenase > upper limit of normal. The primary objective will be to compare the clinical status on day 15, as measured by a 7-point ordinal scale applied in COVID-19 trials worldwide. The primary endpoint will be assessed by an ordinal logistic regression assuming proportional odds ratios adjusted for stratification variables (age and sex).
ETHICS AND DISSEMINATION


The TOCIBRAS protocol was approved by local and central (national) ethical committees in Brazil following current national and international guidelines/directives. Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment. The data derived from this trial will be published regardless of the results. If proven active, this strategy could alleviate the consequences of the inflammatory response in COVID-19 patients and improve their clinical outcomes.",2020,"We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
","['patients with moderate to severe COVID-19', 'patients with COVID-19', 'Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment']","['tocilizumab', 'tocilizumab plus standard of care versus standard of care alone', 'Tocilizumab']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],,0.229721,"We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.
","[{'ForeName': 'Danielle Leão Cordeiro de', 'Initials': 'DLC', 'LastName': 'Farias', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Prats', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Regis Goulart', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Otávio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Organização de Pesquisa Acadêmica, Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Luciano César Pontes de', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brasil.'}, {'ForeName': 'Renato Delascio', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, Estados Unidos.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Avezum', 'Affiliation': 'Centro Internacional de Pesquisa, Hospital Alemão Oswaldo Cruz - São Paulo (SP), Brasil.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Kawano-Dourado', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Lucas Petri', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Salomón Soriano Ordinola', 'Initials': 'SSO', 'LastName': 'Rojas', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Cleyton Zanardo de', 'Initials': 'CZ', 'LastName': 'Oliveira', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Luis Eduardo Coelho', 'Initials': 'LEC', 'LastName': 'Andrade', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Alex Freire', 'Initials': 'AF', 'LastName': 'Sandes', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Maria Carolina', 'Initials': 'MC', 'LastName': 'Pintão', 'Affiliation': 'Fleury Medicina e Laboratórios - São Paulo (SP), Brasil.'}, {'ForeName': 'Claudio Galvão de', 'Initials': 'CG', 'LastName': 'Castro Júnior', 'Affiliation': 'Organização de Pesquisa Acadêmica, Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Scheinberg', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Viviane Cordeiro', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.'}]",Revista Brasileira de terapia intensiva,['10.5935/0103-507X.20200060']
2549,32965505,Personalized predictions of treatment outcome in patients with post-stroke depressive symptoms.,"OBJECTIVE


Post-stroke depressive symptoms have a vast individual and societal impact. However, research into interventions for such symptoms show contradictory results; it is unclear what works for which patients. In addition, clinical prediction tools are lacking. This study aimed to develop a prognostic index model for treatment outcome in patients with post-stroke depressive symptoms.
METHODS


Data from a randomized controlled trial (n = 61) evaluating 2 interventions for post-stroke depressive symptoms were used to predict post-treatment post-stroke depressive symptoms and participation. From 18 pre-treatment variables of patients and caregivers, predictors were selected using elastic net regression. Based on this selection, prognostic index scores (i.e. predictions) for both outcomes were computed for each individual patient.
RESULTS


The depression model included all pre-treatment variables, explaining 44% of the variance. The strongest predictors were: lesion location, employment, participation, comorbidities, mobility, sex, and pre-treatment depression. Six predictors of post-treatment participation were identified, explaining 51% of the variance: mobility, pre-treatment participation, age, satisfaction with participation, caregiver strain, and psychological distress of the spouse. The cross-validated prognostic index scores correlated highly with the actual outcome scores (depression: correlation = 0.672; participation: correlation = 0.718).
CONCLUSION


Post-stroke depressive symptoms form a complex and multifactorial problem. Treatment outcome is influenced by the characteristics of the stroke, the patient, and their spouse. The results show that psychological distress is probably no obstacle to attempting to improve participation. The personalized predictions (prognostic index scores) of treatment outcome show promising results, which, after further replication and validation, could aid clinicians with treatment selection.",2020,"The cross-validated prognostic index scores correlated highly with the actual outcome scores (depression: correlation = 0.672; participation: correlation = 0.718).
",['patients with post-stroke depressive symptoms'],[],"['lesion location, employment, participation, comorbidities, mobility, sex, and pre-treatment depression', 'characteristics of the stroke, the patient, and their spouse', 'satisfaction with participation, caregiver strain, and psychological distress of the spouse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",[],"[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",,0.0596369,"The cross-validated prognostic index scores correlated highly with the actual outcome scores (depression: correlation = 0.672; participation: correlation = 0.718).
","[{'ForeName': 'Johanne C C', 'Initials': 'JCC', 'LastName': 'Rauwenhoff', 'Affiliation': 'School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Bronswijk', 'Affiliation': ''}, {'ForeName': 'Frenk', 'Initials': 'F', 'LastName': 'Peeters', 'Affiliation': ''}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bol', 'Affiliation': ''}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Geurts', 'Affiliation': ''}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Heugten', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2744']
2550,32965537,"Author's Reply to Letters to the Editor: ""A comparison of endoscopic transtympanic myringoplasty and endoscopic type I tympanoplasty for repairing medium- to large-sized tympanic membrane perforation: a randomized clinical trial"".",,2020,,[],['endoscopic transtympanic myringoplasty and endoscopic type I tympanoplasty'],[],[],"[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0442388', 'cui_str': 'Transtympanic approach'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]",[],,0.0406288,,"[{'ForeName': 'Viraporn', 'Initials': 'V', 'LastName': 'Atchariyasathian', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand. viraporn.a@psu.ac.th.'}, {'ForeName': 'Rata', 'Initials': 'R', 'LastName': 'Suwannajak', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Yuvatiya', 'Initials': 'Y', 'LastName': 'Plodpai', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Pittayapon', 'Initials': 'P', 'LastName': 'Pitathawatchai', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06376-y']
2551,32965539,"A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy.","PURPOSE


The purpose of this clinical study was to be the first to explore whether ART-123, a recombinant human soluble thrombomodulin, prevents oxaliplatin-induced peripheral neuropathy (OIPN).
METHODS


This randomized, phase IIa trial enrolled stage II/III colon cancer patients who received adjuvant mFOLFOX6 chemotherapy. Participants were randomly allocated to 3 arms in a double-blind manner: placebo (placebo: days 1-3); 1-day ART (ART-123: day 1, placebo: days 2-3); and 3-day ART (ART-123: days 1-3). ART-123 (380 U/kg/day) or placebo was infused intravenously before each 2-week cycle of mFOLFOX6. OIPN was assessed with the Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) score by participants and the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) by investigators.
RESULTS


Seventy-nine participants (placebo n = 28, 1-day ART n = 27, 3-day ART n = 24) received study drugs. The least-squares mean FACT/GOG-Ntx-12 scores at cycle 12 from the mixed effect model for repeated measures were 28.9 with placebo, 36.3 with 1-day ART (vs. placebo: 7.3 [95% CI 1.9 to12.8, p = 0.009]), and 32.3 with 3-day ART (vs. placebo: 3.4 [95% CI -.1 to 9.0, p = 0.222]). The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5 [95% CI -48.4 to 4.0], p = 0.108), and 45.8% with 3-day ART (vs. placebo: -18.5 [95% CI -44.2 to 9.4], p = 0.264). Common adverse events were consistent with those reported with mFOLFOX6; no severe bleeding adverse events occurred.
CONCLUSION


ART-123 showed a potential preventive effect against OIPN with good tolerability. A larger study with 1-day ART is warranted. NCT02792842, registration date: June 8, 2016.",2020,"The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5","['Seventy-nine participants (placebo n\u2009=\u200928, 1-day ART n\u2009=\u200927, 3-day ART n\u2009=\u200924) received study drugs', 'III colon cancer patients who received']","['ART-123', 'placebo', 'recombinant thrombomodulin (ART-123', 'adjuvant mFOLFOX6 chemotherapy', 'placebo (placebo: days 1-3); 1-day ART (ART-123: day 1, placebo']","['OIPN', 'severe bleeding adverse events', 'Neurotoxicity-12 (FACT/GOG-Ntx-12) score', 'cumulative incidence of NCI-CTCAE grade\u2009≥\u20092 sensory neuropathy']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1174887', 'cui_str': 'ART123'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]",,0.727589,"The cumulative incidence of NCI-CTCAE grade ≥ 2 sensory neuropathy at cycle 12 was 64.3% with placebo, 40.7% with 1-day ART (vs. placebo: -23.5","[{'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Gastrointestinal Cancer Center, Sano Hospital, 2-5-1 Shimizugaoka, Tarumi-ku, Kobe-shi, Hyogo, 655-0031, Japan. tomomakotaka6410@yahoo.co.jp.'}, {'ForeName': 'Yoji', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Anesthesiology, Shimane University Faculty of Medicine, 89-1 Enyacho, Izumo City, Shimane, 693-8501, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterological Surgery, Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki-shi, Hyogo, 660-8511, Japan.'}, {'ForeName': 'Hironaga', 'Initials': 'H', 'LastName': 'Satake', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, 2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo, 650-0047, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, 1-8-1 Kishinoura, Yahatanishi-ku, Kitakyusyu-shi, Fukuoka, 806-8501, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Tonan Hospital, Kita 4-jo Nishi 7-chome 3-8, Chuo-ku, Sapporo-shi, Hokkaido, 060-0004, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, 1-5-54 Ujinakanda, Minami-ku, Hiroshima-shi, Hiroshima, 734-8530, Japan.'}, {'ForeName': 'Toshiyoshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan.'}, {'ForeName': 'Tsunekazu', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastrointestinal Surgery, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Harihara', 'Affiliation': 'Department of Surgery, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-8625, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nagata', 'Affiliation': 'Department of Surgery, Kitakyushu General Hospital, 1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu, 802-8517, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kurihara', 'Affiliation': 'Department of Surgery, Nerima General Hospital, 1-24-1 Asahigaoka, Nerima-ku, Tokyo, 176-8530, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.'}, {'ForeName': 'Genichi', 'Initials': 'G', 'LastName': 'Kusakawa', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Sakai', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Uchida', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Mikihiro', 'Initials': 'M', 'LastName': 'Takamoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kimoto', 'Affiliation': 'Clinical Development Center, Asahi Kasei Pharma Corporation, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, 100-0006, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04135-8']
2552,32965581,Balneotherapy with a psychoeducation program for the promotion of a balanced care in family caregivers of older adults.,"This study aimed to analyze the efficacy of an intervention program for informal caregivers of elderly dependent that combined balneotherapy with group psychoeducation (BT-PE) based on the balanced care model. The BT-PE intervention (N = 124) was compared with a comparison group only exposed to balneotherapy (BT) (N = 76). The two modalities included both primary and secondary informal caregivers. A three-way mixed ANOVA was conducted to determine the effects of two between-subjects´ factors (intervention group and caregiver type) and one within-subjects´ factor (time) on burden, depression, anxiety, maladjustment and care satisfaction. Results showed less burden and more care satisfaction in both primary and secondary caregivers participating in the BT-PE program after the interventions. Primary caregivers also showed lower levels of maladjustment in the experimental group at post-intervention. Although depressive symptoms and anxiety decreased significantly in both intervention groups, BT-PE did not show lower scores compared with the application of sole BT. The relevance of caregivers´ psychoeducation on the balanced care model and its combination with balneotherapy is highlighted.",2020,"Although depressive symptoms and anxiety decreased significantly in both intervention groups, BT-PE did not show lower scores compared with the application of sole BT.","['family caregivers of older adults', 'informal caregivers of elderly dependent that combined']","['balneotherapy (BT', 'intervention program', 'BT-PE intervention', 'balneotherapy with group psychoeducation (BT-PE', 'Balneotherapy with a psychoeducation program']","['depressive symptoms and anxiety', 'burden, depression, anxiety, maladjustment and care satisfaction', 'care satisfaction']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0085867', 'cui_str': 'Balneotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037423', 'cui_str': 'Social maladjustment'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",124.0,0.0228224,"Although depressive symptoms and anxiety decreased significantly in both intervention groups, BT-PE did not show lower scores compared with the application of sole BT.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Noriega', 'Affiliation': 'Department of Psychology and Pedagogy, School of Medicine, Universidad San Pablo-CEU, CEU Universities, Campus de Montepríncipe, 28925, Alcorcón, Madrid, Spain. cristina.noriegagarcia@ceu.es.'}, {'ForeName': 'María Dolores', 'Initials': 'MD', 'LastName': 'Ortiz', 'Affiliation': 'Unión Democrática de Pensionistas y Jubilados de España (UDP), Madrid, Spain.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Martínez', 'Affiliation': 'Unión Democrática de Pensionistas y Jubilados de España (UDP), Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'López', 'Affiliation': 'Department of Psychology and Pedagogy, School of Medicine, Universidad San Pablo-CEU, CEU Universities, Campus de Montepríncipe, 28925, Alcorcón, Madrid, Spain.'}]",International journal of biometeorology,['10.1007/s00484-020-02018-4']
2553,32965585,Rationale and Design of the H-REPLACE Study: Safety and Efficacy of LMWH Versus Rivaroxaban in ChinEse Patients HospitaLized with Acute Coronary SyndromE.,"BACKGROUND


Acute coronary syndrome (ACS) is a serious and life-threatening condition. Anticoagulation during the acute phase of ACS is effective in reducing ischemic events. The most widely used parenteral anticoagulation agent in ACS patients is enoxaparin. Rivaroxaban is a novel oral anticoagulant with potent anti-Xa activity, which might be an attractive alternative drug to enoxaparin. In fact, rivaroxaban was consistently shown to be non-inferior to enoxaparin therapy in terms of reduction of recurrent venous thromboembolism events.
OBJECTIVE


This prospective, randomized, open-label, active-controlled, multicenter study is designed to compare the safety and efficacy of rivaroxaban versus enoxaparin in patients with ACS, who missed the primary reperfusion therapy window and before selective revascularization.
METHODS AND RESULTS


Up to 2055 participants receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly assigned to either oral rivaroxaban 2.5 mg twice daily or rivaroxaban 5 mg twice daily or subcutaneous enoxaparin 1 mg/kg twice daily until hospital discharge for a maximum of 8 days or 12 h before revascularization therapy. The primary safety endpoint is the International Society on Thrombosis and Hemostasis definition of bleeding events [minor, clinically relevant non-major and major bleeding]. The primary efficacy endpoint is a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, re-revascularization or stroke, and major bleeding events. Secondary endpoints include cardiac-related rehospitalization and all-cause death. Patients will be followed for 12 months after randomization.
CONCLUSIONS


The H-REPLACE trial offers an opportunity to assess clinical outcomes of rivaroxaban versus enoxaparin during the acute phase of ACS and may provide an alternative anticoagulation strategy for ACS patients, who missed the primary reperfusion therapy window and before selective revascularization.
TRIAL REGISTRATION


ClinicalTrials.gov; NCT03363035.",2020,"The primary efficacy endpoint is a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, re-revascularization or stroke, and major bleeding events.","['ChinEse Patients HospitaLized with Acute Coronary SyndromE', '2055 participants receiving background treatment of', 'patients with ACS, who missed the primary reperfusion therapy window and before selective revascularization']","['rivaroxaban', 'LMWH Versus Rivaroxaban', 'aspirin plus clopidogrel or ticagrelor', 'Rivaroxaban', '5\xa0mg twice daily or subcutaneous', 'oral rivaroxaban 2.5\xa0mg twice daily or rivaroxaban', 'enoxaparin']","['International Society on Thrombosis and Hemostasis definition of bleeding events [minor, clinically relevant non-major and major bleeding', 'cardiac-related rehospitalization and all-cause death', 'safety and efficacy', 'ischemic events', 'composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, re-revascularization or stroke, and major bleeding events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4731644', 'cui_str': 'rivaroxaban 2.5 MG'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",2055.0,0.0643077,"The primary efficacy endpoint is a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, re-revascularization or stroke, and major bleeding events.","[{'ForeName': 'Yichao', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.""}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.""}, {'ForeName': 'Xinqun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.""}, {'ForeName': 'Zhenfei', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China.""}, {'ForeName': 'Shenghua', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ""Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, People's Republic of China. zhoushenghua@csu.edu.cn.""}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-07076-9']
2554,32963266,Local anaesthesia decreases nerve growth factor induced masseter hyperalgesia.,"The aim of this investigation was to evaluate the effects of local anaesthesia on nerve growth factor (NGF) induced masseter hyperalgesia. Healthy participants randomly received an injection into the right masseter muscle of either isotonic saline (IS) given as a single injection (n = 15) or an injection of NGF (n = 30) followed by a second injection of lidocaine (NGF + lidocaine; n = 15) or IS (NGF + IS; n = 15) in the same muscle 48 h later. Mechanical sensitivity scores of the right and left masseter, referred sensations and jaw pain intensity and jaw function were assessed at baseline, 48 h after the first injection, 5 min after the second injection and 72 h after the first injection. NGF caused significant jaw pain evoked by chewing at 48 and 72 h after the first injection when compared to the IS group, but without significant differences between the NGF + lidocaine and NGF + IS groups. However, the mechanical sensitivity of the right masseter 5 min after the second injection in the NGF + lidocaine group was significantly lower than the second injection in the NGF + IS and was similar to the IS group. There were no significant differences for the referred sensations. Local anaesthetics may provide relevant information regarding the contribution of peripheral mechanisms in the maintenance of persistent musculoskeletal pain.",2020,"NGF caused significant jaw pain evoked by chewing at 48 and 72 h after the first injection when compared to the IS group, but without significant differences between the NGF + lidocaine and NGF + IS groups.",['Healthy participants'],"['NGF\u2009+\u2009lidocaine', 'NGF', 'lidocaine (NGF\u2009+\u2009lidocaine; n\u2009=\u200915) or IS (NGF\u2009+\u2009IS; n\u2009=\u200915) in the same muscle 48\xa0h later', 'isotonic saline (IS) given as a single injection (n\u2009=\u200915) or an injection of NGF', 'local anaesthesia', 'lidocaine']","['jaw pain evoked by chewing', 'mechanical sensitivity', 'Mechanical sensitivity scores of the right and left masseter, referred sensations and jaw pain intensity and jaw function']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0236000', 'cui_str': 'Jaw pain'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0446219,"NGF caused significant jaw pain evoked by chewing at 48 and 72 h after the first injection when compared to the IS group, but without significant differences between the NGF + lidocaine and NGF + IS groups.","[{'ForeName': 'Yuri M', 'Initials': 'YM', 'LastName': 'Costa', 'Affiliation': 'Department of Biosciences, Piracicaba Dental School, University of Campinas, Av. Limeira, 901, Piracicaba, CEP 13414-903, Brazil. yuricosta@fop.unicamp.br.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Exposto', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Eduardo E', 'Initials': 'EE', 'LastName': 'Castrillon', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Paulo César R', 'Initials': 'PCR', 'LastName': 'Conti', 'Affiliation': 'Department of Prosthodontics, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Leonardo R', 'Initials': 'LR', 'LastName': 'Bonjardim', 'Affiliation': 'Section of Head and Face Physiology, Department of Biological Sciences, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Section of Orofacial Pain and Jaw Function, Department of Dentistry and Oral Health, Aarhus University, Aarhus, Denmark.'}]",Scientific reports,['10.1038/s41598-020-71620-8']
2555,32963294,Omega-3 index and blood pressure responses to eating foods naturally enriched with omega-3 polyunsaturated fatty acids: a randomized controlled trial.,"Diets low in seafood omega-3 polyunsaturated fatty acids (PUFAs) are very prevalent. Such diets have recently been ranked as the sixth most important dietary risk factor-1.5 million deaths and 33 million disability-adjusted life-years worldwide are attributable to this deficiency. Wild oily fish stocks are insufficient to feed the world's population, and levels of eicosapentaenoic acid and docosahexaenoic acid (DHA) in farmed fish have more than halved in the last 20 years. Here we report on a double-blinded, controlled trial, where 161 healthy normotensive adults were randomly allocated to eat at least three portions/week of omega-3-PUFA enriched (or control) chicken-meat, and to eat at least three omega-3-PUFA enriched (or control) eggs/week, for 6 months. We show that regular consumption of omega-3-PUFA enriched chicken-meat and eggs significantly increased the primary outcome, the red cell omega-3 index (mean difference [98.75% confidence interval] from the group that ate both control foods, 1.7% [0.7, 2.6]). Numbers of subjects with a very high-risk omega-3 index (index < 4%) were more than halved amongst the group that ate both enriched foods. Furthermore, eating the enriched foods resulted in clinically relevant reductions in diastolic blood pressure (- 3.1 mmHg [- 5.8, - 0.3]). We conclude that chicken-meat and eggs, naturally enriched with algae-sourced omega-3-PUFAs, may serve as alternative dietary sources of these essential micronutrients. Unlike many lifestyle interventions, long-term population health benefits do not depend on willingness of individuals to make long-lasting difficult dietary changes, but on the availability of a range of commonly eaten, relatively inexpensive, omega-3-PUFA enriched foods.",2020,"Furthermore, eating the enriched foods resulted in clinically relevant reductions in diastolic blood pressure (- 3.1 mmHg [- 5.8, - 0.3]).","['Numbers of subjects with a very high-risk omega-3 index (index\u2009<\u20094', '161 healthy normotensive adults']","['omega-3-PUFA enriched (or control) chicken-meat, and to eat at least three omega-3-PUFA', 'omega-3 polyunsaturated fatty acids']","['Omega-3 index and blood pressure responses', 'red cell omega-3 index', 'diastolic blood pressure']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0677521', 'cui_str': 'Chicken - meat'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",161.0,0.161961,"Furthermore, eating the enriched foods resulted in clinically relevant reductions in diastolic blood pressure (- 3.1 mmHg [- 5.8, - 0.3]).","[{'ForeName': 'Alice V', 'Initials': 'AV', 'LastName': 'Stanton', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland. astanton@rcsi.ie.'}, {'ForeName': 'Kirstyn', 'Initials': 'K', 'LastName': 'James', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Brennan', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': ""O'Donovan"", 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Buskandar', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Shortall', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Thora', 'Initials': 'T', 'LastName': 'El-Sayed', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Kennedy', 'Affiliation': 'Devenish Nutrition, Belfast, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hayes', 'Affiliation': 'Devenish Nutrition, Belfast, UK.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Fahey', 'Affiliation': 'University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Pender', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Simon A M', 'Initials': 'SAM', 'LastName': 'Thom', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Moran', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Williams', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}, {'ForeName': 'Eamon', 'Initials': 'E', 'LastName': 'Dolan', 'Affiliation': 'Royal College of Surgeons in Ireland, RCSI Education & Research Centre, The Smurfit Building, Beaumont Hospital, Beaumont Road, Dublin 9, DO9 YD60, Ireland.'}]",Scientific reports,['10.1038/s41598-020-71801-5']
2556,32963362,The association between urine neutrophil gelatinase-associated lipocalin and UTI in people with neurogenic lower urinary tract dysfunction.,"STUDY DESIGN


Secondary analysis of urine samples collected from a prospective within-subject clinical trial.
OBJECTIVES


Describe the baseline variation in urine neutrophil gelatinase-associated lipocalin (uNGAL) levels in adults with neurogenic lower urinary tract dysfunction (NLUTD) and determine if uNGAL levels vary according to likelihood of having a UTI.
SETTING


Greater Washington D.C. region.
METHODS


Urine samples were collected from a cohort of adults with NLUTD from a clinical trial. Samples were divided into groups of ""Not UTI"", ""Unlikely UTI"", and ""Likely UTI"" based on symptoms and urine culture results. uNGAL was compared between groups using Kruskal-Wallis and post hoc Dunn's test. Mixed effects logistic model was used to assess the association of uNGAL and Likely UTI.
RESULTS


Twenty-seven participants provided a total of 104 samples. uNGAL levels were lowest for the No UTI group (n = 29; 37 ng/ml interquartile range (IQR) (15, 71)), intermediate for the Unlikely UTI group (n = 67; 95 ng/ml IQR (37, 161)) and highest for the Likely UTI group (n = 8; 187 ng/ml IQR(146, 224)). uNGAL levels were higher in those with Likely UTI compared to both Unlikely UTI (p < 0.05) and No UTI (p < 0.01). uNGAL had an association with Likely UTI (OR 1.01, 95% CI (1.00-1.02), p = 0.049).
CONCLUSIONS


Adults with NLUTD have notable variation in uNGAL levels in the absence of symptoms potentially due to UTI. uNGAL levels are higher in those who are likely to have UTI have higher uNGAL levels compared to those with non-specific symptoms and/or less growth on urine culture. uNGAL may have utility as a marker of UTI in people with NLUTD.
SPONSORSHIP


Patient-Centered Outcomes Research Institute (PCORI) funded this work. Bioporto provided partial salary support for SLG, IL, and OKL. NGAL ELISAs were provided by Bioporto in kind.",2020,uNGAL levels were higher in those with Likely UTI compared to both Unlikely UTI (p < 0.05) and No UTI (p < 0.01).,"['Twenty-seven participants provided a total of 104 samples', 'Secondary analysis of urine samples collected from a prospective within-subject clinical trial', 'Greater Washington D.C. region', 'Urine samples were collected from a cohort of adults with NLUTD from a clinical trial', 'people with neurogenic lower urinary tract dysfunction', 'people with NLUTD', 'adults with neurogenic lower urinary tract dysfunction (NLUTD']",[],"['uNGAL levels', 'urine neutrophil gelatinase-associated lipocalin (uNGAL) levels']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0012764', 'cui_str': 'District of Columbia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",27.0,0.127886,uNGAL levels were higher in those with Likely UTI compared to both Unlikely UTI (p < 0.05) and No UTI (p < 0.01).,"[{'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Forster', 'Affiliation': 'Biomedical Research Institute, Rockville, MD, 20850, USA. forstercs@upmc.edu.'}, {'ForeName': 'Olivia K', 'Initials': 'OK', 'LastName': 'Lamanna', 'Affiliation': 'Biomedical Research Institute, Rockville, MD, 20850, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rounds', 'Affiliation': 'MedStar National Rehabilitation Hospital, Washington, DC, 20010, USA.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Sprague', 'Affiliation': ""Children's National Hospital, Washington, DC, 20010, USA.""}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Ljungberg', 'Affiliation': 'MedStar National Rehabilitation Hospital, Washington, DC, 20010, USA.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Groah', 'Affiliation': 'MedStar National Rehabilitation Hospital, Washington, DC, 20010, USA.'}]",Spinal cord,['10.1038/s41393-020-00552-x']
2557,32963436,Comparison of Commercially Available Balanced Salt Solution and Ringer's Lactate on Extent of Correction of Metabolic Acidosis in Critically Ill Patients.,"Introduction


Appropriate early fluid resuscitation is ubiquitous for critically ill patients with metabolic acidosis. Owing to harmful effects of normal saline, commercially prepared balanced salt solutions are being used. However, there is no study comparing use of Ringer's lactate (RL) and commercially available balanced salt solutions in critically ill patients.
Materials and methods


A randomized controlled trial was conducted during July 2016 to December 2017. Fifty adult patients admitted to intensive care unit with metabolic acidosis were randomized into group RL or group acetate solution (AC). Respective trial fluid was administered at 20 mL/kg/hour for first hour and 10 mL/kg/hour for second hour. Arterial blood gas analysis samples were taken 15 minutes apart. The fluid resuscitation was continued till pH got corrected to 7.3 or 2 hours, whichever was earlier. The primary aim was to compare time to correct metabolic acidosis in both the groups. The secondary outcomes were the extent of correction of metabolic acidosis, total volume of fluid used, and total cost per patient.
Results


Demographic parameters, APACHE II score, and baseline investigations were comparable. The metabolic acidosis got corrected in 12 patients in group AC and 10 patients in group RL ( p  value = 0.66). The mean time for correction of metabolic acidosis was 57 ± 3.85 minutes in group RL and 56.25 ± 4.22 minutes in group AC ( p  value =0.95). The extent of correction of metabolic acidosis and total volume of fluid used was also comparable ( p  value = 0.05). However, the cost of fluid used was significantly higher in group AC ( p  value < 0.01).
Conclusion


During administration of balanced salt solutions, RL or AC, in critically ill patients with metabolic acidosis, AC did not confer any advantage in time to or extent of correction of metabolic acidosis.
Clinical significance


There is no difference in acid-base status with use of different types of balanced salt solutions for resuscitation in critically ill patients.
How to cite this article


Rawat N, Sahni N, Yaddanapudi L. Comparison of Commercially Available Balanced Salt Solution and Ringer's Lactate on Extent of Correction of Metabolic Acidosis in Critically Ill Patients. Indian J Crit Care Med 2020;24(7):539-543.",2020,The extent of correction of metabolic acidosis and total volume of fluid used was also comparable ( p  value = 0.05).,"['Fifty adult patients admitted to intensive care unit with metabolic acidosis', 'critically ill patients with metabolic acidosis', 'Critically Ill Patients', 'critically ill patients', 'July 2016 to December 2017']","['normal saline', ""Ringer's lactate (RL"", 'RL or group acetate solution (AC', ""Commercially Available Balanced Salt Solution and Ringer's Lactate"", 'balanced salt solutions, RL or AC']","['mean time for correction of metabolic acidosis', 'metabolic acidosis', 'Metabolic Acidosis', 'Arterial blood gas analysis samples', 'extent of correction of metabolic acidosis, total volume of fluid used, and total cost per patient', 'metabolic acidosis and total volume of fluid', 'time to correct metabolic acidosis', 'cost of fluid used']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C3653289', 'cui_str': 'Salt solutions'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449896', 'cui_str': 'Fluid used'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",50.0,0.0493282,The extent of correction of metabolic acidosis and total volume of fluid used was also comparable ( p  value = 0.05).,"[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Rawat', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Neeru', 'Initials': 'N', 'LastName': 'Sahni', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Lakshminarayana', 'Initials': 'L', 'LastName': 'Yaddanapudi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]","Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine",['10.5005/jp-journals-10071-23488']
2558,32965623,Melatonin ingestion before intradialytic exercise improves immune responses in hemodialysis patients.,"PURPOSE


The present study aimed to investigate the effects of melatonin (MEL) intake on systemic inflammation and immune responses during intradialytic exercise.
METHODS


Thirteen hemodialysis (HD) patients volunteered to participate in the current randomized-crossover study. Immunological responses were monitored in four HD sessions at different conditions: [Exercise (EX) + MEL], [EX + Placebo (PLA)], [Control (CON) + MEL] and [CON + PLA]. MEL (3 mg) or PLA was ingested 1 h before starting exercise or the equivalent time in CON condition. During all sessions, peripheral blood samples were collected to assess c-reactive protein, complete blood count, and immune cells phenotypes before HD (T0), immediately after exercise (T1) and 1 h after exercise (T2) or at corresponding times in the CON condition.
RESULTS


HD therapy induced a significant decrease in natural killer (NK) (p = 0.001, d = 0.85; p < 0.001, d = 1.19, respectively) and CD8 +  T-lymphocytes rates (p = 0.001, d = 0.57; p < 0.001, d = 0.75, respectively) at T1 and T2 compared to T0. MEL intake prevented the decrease in NK and CD8 +  T-lymphocytes, increased the proportion of CD4 +  T-lymphocytes at T1 and T2 compared to T0 (p = 0.002, d = 1.18; p = 0.001, d = 1.04, respectively) and decreased the proportion of CD14 ++ CD16 +  Monocytes at T2 compared to T0 (p = 0.02, d = 1.57) in peripheral blood during HD therapy. Similar results were found in [EX + MEL] and [EX + PLA] conditions.
CONCLUSION


This pilot study provides the first evidence that MEL intake alone or associated with intradialytic exercise displays potential immunoregulatory and anti-inflammatory effects. The combination of MEL with intradialytic exercise may be an appropriate anti-inflammatory therapy for HD patients.",2020,"MEL intake prevented the decrease in NK and CD8 +  T-lymphocytes, increased the proportion of CD4 +  T-lymphocytes at T1 and T2 compared to T0 (p = 0.002, d = 1.18; p = 0.001, d = 1.04, respectively) and decreased the proportion of CD14 ++ CD16 +  Monocytes at T2 compared to T0 (p = 0.02, d = 1.57) in peripheral blood during HD therapy.","['Thirteen hemodialysis (HD) patients volunteered to participate in the current randomized-crossover study', 'HD patients', 'hemodialysis patients']","['MEL', 'Exercise (EX)\u2009+\u2009MEL], [EX\u2009+\u2009Placebo (PLA)], [Control (CON)\u2009+\u2009MEL] and [CON\u2009+\u2009PLA', 'melatonin (MEL) intake', 'Melatonin ingestion before intradialytic exercise', 'MEL with intradialytic exercise']","['Immunological responses', 'CD8 +  T-lymphocytes rates', 'proportion of CD4 +  T-lymphocytes', 'proportion of CD14 ++ CD16 +  Monocytes', 'natural killer\xa0(NK', 'c-reactive protein, complete blood count, and immune cells phenotypes before HD (T0), immediately after exercise (T1) and 1\xa0h after exercise (T2', 'NK and CD8 +  T-lymphocytes', 'immune responses']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C2724208', 'cui_str': '++'}, {'cui': 'C0108747', 'cui_str': 'Lymphocyte antigen CD16'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0427385', 'cui_str': 'Cell phenotype determination'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}]",13.0,0.017596,"MEL intake prevented the decrease in NK and CD8 +  T-lymphocytes, increased the proportion of CD4 +  T-lymphocytes at T1 and T2 compared to T0 (p = 0.002, d = 1.18; p = 0.001, d = 1.04, respectively) and decreased the proportion of CD14 ++ CD16 +  Monocytes at T2 compared to T0 (p = 0.02, d = 1.57) in peripheral blood during HD therapy.","[{'ForeName': 'Houssem', 'Initials': 'H', 'LastName': 'Marzougui', 'Affiliation': 'Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia. hammouda.o@parisnanterre.fr.'}, {'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Ben Dhia', 'Affiliation': 'High Institute of Sport and Physical Education, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Maaloul', 'Affiliation': 'Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Ikram', 'Initials': 'I', 'LastName': 'Agrebi', 'Affiliation': 'Nephrology Department, Hedi Chaker University Hospital, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Hanen', 'Initials': 'H', 'LastName': 'Chaker', 'Affiliation': 'Nephrology Department, Hedi Chaker University Hospital, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Khaoula', 'Initials': 'K', 'LastName': 'Kammoun', 'Affiliation': 'Nephrology Department, Hedi Chaker University Hospital, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ben Hmida', 'Affiliation': 'Nephrology Department, Hedi Chaker University Hospital, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ayadi', 'Affiliation': 'Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Choumous', 'Initials': 'C', 'LastName': 'Kallel', 'Affiliation': 'Laboratory of Hematology, Habib Bourguiba University Hospital, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical Activity, Health and Learning (LINP2), UFR STAPS, UPL, Paris Nanterre University, 92000, Nanterre, France.'}, {'ForeName': 'Mouna', 'Initials': 'M', 'LastName': 'Turki', 'Affiliation': 'Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Masmoudi', 'Affiliation': 'Immunology Department, Habib Bourguiba University Hospital, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Hend', 'Initials': 'H', 'LastName': 'Hachicha', 'Affiliation': 'Immunology Department, Habib Bourguiba University Hospital, University of Sfax, Sfax, Tunisia.'}]",International urology and nephrology,['10.1007/s11255-020-02643-3']
2559,32965655,"PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis.","BACKGROUND


Psoriasis vulgaris is commonly treated with topical corticosteroids and vitamin D analogues. Although potent and super-potent topical corticosteroids are very effective at clearing psoriasis, with short-term reactive treatment durations, symptoms usually recur after treatment discontinuation, necessitating long-term disease management strategies. A foam formulation of calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g, is approved for the daily treatment of psoriasis for up to 4 weeks. Here, we describe a clinical trial protocol for evaluating the long-term safety and efficacy of twice-weekly Cal/BD foam as a proactive topical maintenance therapy for plaque psoriasis for up to 52 weeks.
OBJECTIVE


The aim of this trial was to evaluate the safety and efficacy of Cal/BD foam when applied twice weekly for up to 52 weeks as proactive maintenance therapy, with the goal of preventing or delaying disease relapse as long as possible while minimizing adverse effects.
METHODS


Once-daily Cal/BD foam treatment responders from an initial 4-week open-label period were randomized to receive Cal/BD foam or foam vehicle applied to previously cleared plaques twice weekly for up to 52 weeks. In case of relapse, affected subjects in either group received rescue therapy with once-daily Cal/BD foam for 4 weeks on active areas. Thus, the trial (NCT02899962) compared the long-term use of Cal/BD foam in a proactive approach with a conventional, reactive approach.
PLANNED OUTCOMES


Efficacy endpoints included the time to first relapse, the number of relapse-free days, and the number of relapses during the maintenance phase. Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02899962.",2020,"Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
","['plaque psoriasis for up to 52\xa0weeks', 'in Psoriasis']","['Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam', 'calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50\xa0μg', 'betamethasone dipropionate']","['adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function', 'safety and efficacy', 'time to first relapse, the number of relapse-free days, and the number of relapses']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0714231,"Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': 'Department of Dermatology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Alonso-Llamazares', 'Affiliation': 'Department of Dermatology, VA Medical Center, Miami, FL, USA.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester BRC University of Manchester, Manchester, UK.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yamauchi', 'Affiliation': 'Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA. lebwohl@aol.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01497-6']
2560,32965659,Long-Term Ivacaftor in People Aged 6 Years and Older with Cystic Fibrosis with Ivacaftor-Responsive Mutations.,"INTRODUCTION


Mutations in the cystic fibrosis transmembrane conductance regulator gene (CFTR) affect the quantity and/or function of CFTR protein reaching the cell surface. Ivacaftor, a CFTR potentiator that enhances chloride transport, increases the channel-open probability of normal and dysfunctional CFTR. Initially approved for people with CF (pwCF) with G551D-CFTR gating mutations, ivacaftor demonstrated clinical benefit in pwCF with other gating mutations and certain residual function mutations, including R117H-CFTR, in clinical studies. We evaluated the long-term safety and efficacy of ivacaftor in pwCF aged 6 years and older with non-G551D-CFTR ivacaftor-responsive mutations.
METHODS


Efficacy and safety data from a phase 3, multicenter, open-label, extension study for participants from Study 110 (R117H-CFTR mutations), Study 111 (non-G551D-CFTR gating mutations), and Study 113 (n-of-1 pilot study in participants with residual CFTR function) were analyzed. Following washout from the randomized parent study, participants received oral ivacaftor 150 mg once every 12 h for 104 weeks.
RESULTS


Forty-one of 121 participants completed treatment through 104 weeks; 59 participants who did not complete the extension study continued treatment with commercial ivacaftor. The most common adverse events were pulmonary exacerbation (46.3%) and cough (33.9%). Most treatment-emergent adverse events were mild/moderate in severity and consistent with manifestations of CF or the ivacaftor safety profile. Rapid, durable improvement occurred across all efficacy endpoints.
CONCLUSIONS


Ivacaftor was generally safe and well tolerated with no new safety concerns for up to 104 weeks in pwCF with ivacaftor-responsive mutations. The pattern of improvement across efficacy endpoints was durable and generally consistent with parent-study outcomes.
TRIAL REGISTRATION


NCT01707290.",2020,"CONCLUSIONS


Ivacaftor was generally safe and well tolerated with no new safety concerns for up to 104 weeks in pwCF with ivacaftor-responsive mutations.","['Forty-one of 121 participants completed treatment through 104\xa0weeks; 59 participants who did not complete the extension study continued treatment with commercial ivacaftor', 'People', 'Aged 6 Years and Older with Cystic Fibrosis with Ivacaftor-Responsive Mutations', 'pwCF aged 6\xa0years and older with non-G551D-CFTR ivacaftor-responsive mutations', 'participants from Study 110 (R117H-CFTR mutations), Study 111 (non-G551D-CFTR gating mutations), and Study 113 (n-of-1 pilot study in participants with residual CFTR function']","['oral ivacaftor', 'ivacaftor']","['cough', 'safe and well tolerated']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}]",121.0,0.0483752,"CONCLUSIONS


Ivacaftor was generally safe and well tolerated with no new safety concerns for up to 104 weeks in pwCF with ivacaftor-responsive mutations.","[{'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Pilewski', 'Affiliation': 'University of Pittsburgh, UPMC Montefiore Hospital, NW628, 3459 Fifth Ave, Pittsburgh, PA, 15213, USA. pilewskijm@upmc.edu.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'De Boeck', 'Affiliation': 'Faculty of Medicine, University Hospital of Leuven, Herestraat 49, 3000, Leuven, Belgium.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Nick', 'Affiliation': 'National Jewish Health, 1400 Jackson St, Denver, CO, 80206, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, 50 Northern Ave, Boston, MA, 02210, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'DeSouza', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, 50 Northern Ave, Boston, MA, 02210, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Higgins', 'Affiliation': 'Vertex Pharmaceuticals (Europe) Limited, 2 Kingdom St, London, W2 6BD, UK.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Moss', 'Affiliation': 'Center of Excellence in Pulmonary Biology, Stanford University School of Medicine, 770 Welch Rd #350, Palo Alto, CA, 94304, USA.'}]",Pulmonary therapy,['10.1007/s41030-020-00129-2']
2561,32965691,"Effects of different mean arterial pressure targets on plasma volume, ANP and glycocalyx - A randomised trial.","BACKGROUND


Arterial haematocrit (Hct) has been shown to decrease after anaesthesia induction, most probably because of an increased plasma volume (PV). The primary objective was to quantify change in PV if mean arterial pressure (MAP) was kept at baseline level or allowed to decrease to 60 mmHg. Our secondary objective was to evaluate underlying mechanisms of this response.
METHODS


Twenty-four coronary artery bypass patients were randomised to a higher (90 mmHg, intervention group) or lower (60 mmHg, control group) MAP by titration of norepinephrine. During the experimental procedure, no fluids were administered. Baseline PV was measured by  125  I-albumin and the change in PV was calculated from the change in Hct. Changes in MAP, plasma  125  I-albumin, colloid osmotic pressure, albumin, Mid Regional-pro Atrial Natriuretic Peptide (MR-proANP) and endothelial glycocalyx components were measured from baseline to 50 min after anaesthesia induction.
RESULTS


The MAP during the trial was 93 ± 9 mmHg in the intervention group and 62 ± 5 mmHg in the control group. PV increased with up to 420 ± 180 ml in the control group and 45 ± 130 ml in the intervention group (p<0.001). Albumin and colloid osmotic pressure decreased significantly more in the control group. MR-proANP increased in the control group but no shedding of the glycocalyx layer was detected in either of the groups.
CONCLUSION


Allowing mean arterial pressure to fall to 60 mmHg during anesthesia induction, increases the plasma volume due to reabsorption of interstitial water, with no ANP-induced degradation of the endothelial glycocalyx.",2020,The MAP during the trial was 93 ± 9 mmHg in the intervention group and 62 ± 5 mmHg in the control group.,['Twenty-four coronary artery bypass patients'],['norepinephrine'],"['Albumin and colloid osmotic pressure', 'Baseline PV', 'glycocalyx layer', 'PV', 'plasma volume (PV', 'PV if mean arterial pressure (MAP', 'MR-proANP', 'Changes in MAP, plasma  125  I-albumin, colloid osmotic pressure, albumin, Mid Regional-pro Atrial Natriuretic Peptide (MR-proANP) and endothelial glycocalyx components']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0029393', 'cui_str': 'Osmotic pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",24.0,0.08616,The MAP during the trial was 93 ± 9 mmHg in the intervention group and 62 ± 5 mmHg in the control group.,"[{'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Damén', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, and Sahlgrenska University Hospital, Section of Cardiothoracic Anaesthesia and Intensive Care, Gothenburg, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Saadati', 'Affiliation': 'Department of Radiation Physics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Forssell-Aronsson', 'Affiliation': 'Department of Radiation Physics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Hesse', 'Affiliation': 'Department of Laboratory Medicine, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentzer', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Helsingborg Hospital, Helsingborg and Lund University, Helsingborg, Sweden.'}, {'ForeName': 'Sven-Erik', 'Initials': 'SE', 'LastName': 'Ricksten', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, and Sahlgrenska University Hospital, Section of Cardiothoracic Anaesthesia and Intensive Care, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Nygren', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences at the Sahlgrenska Academy, University of Gothenburg, and Sahlgrenska University Hospital, Section of Cardiothoracic Anaesthesia and Intensive Care, Gothenburg, Sweden.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13710']
2562,32965787,"Airway mechanics after withdrawal of a leukotriene receptor antagonist in children with mild-persistent asthma: double blind, randomized, cross-over study.","BACKGROUND


To determine the response of airway mechanics and the changes in asthma symptoms to stepping down of leukotriene receptor antagonist (LTRA) therapy.
METHODS


Thirty children (mean age: 7.1 years) with mild, well-controlled, and persistent asthma who took LTRA as maintenance treatment were randomized into a double-blind, placebo-controlled, cross-over study. Each group received an LTRA (montelukast) or placebo daily for 2 weeks, followed by a 1-week washout period, and then the alternate treatment for 2 weeks. Spirometry and impulse oscillation system (IOS) measurements before and after 4 puffs of salbutamol inhalation, fractional exhaled nitric oxide (FeNO), and the childhood asthma control test (C-ACT) were evaluated at baseline, the end of placebo treatment, and the end of LTRA treatment.
RESULTS


Changes of FEV 1  /FVC (P = 0.113) and FEV 1  (P = 0.109) from baseline to post-treatment did not differ significantly between the placebo and montelukast groups. In the placebo group, prebronchodilator (pre-) FEV 1  /FVC was decreased (83% vs. 86%) and bronchodilator response (BDR) in FEV 1  was diminished (10.7% vs. 6.4%) at post-treatment compared to baseline. However, the montelukast group had no significant changes of pre-FEV 1  /FVC (P = 0.865) and BDR in FEV 1  (P = 0.461). In addition, compared to the montelukast group, the placebo group showed no significant changes in Rrs5 (total airway resistance), Rrs5-20 (peripheral airway resistance), FeNO, and symptoms by the C-ACT.
CONCLUSION


In children with well-controlled mild-persistent asthma, changes in spirometry, IOS, FeNO and C-ACT results did not differ between the placebo and montelukast groups within 2 weeks. This article is protected by copyright. All rights reserved.",2020,(P = 0.113) and FEV 1  (P = 0.109) from baseline to post-treatment did not differ significantly between the placebo and montelukast groups.,"['children with mild-persistent asthma', 'Thirty children (mean age: 7.1 years) with mild, well-controlled, and persistent asthma who took LTRA as maintenance treatment']","['leukotriene receptor antagonist (LTRA) therapy', 'leukotriene receptor antagonist', 'LTRA (montelukast) or placebo', 'placebo', 'montelukast', 'FVC']","['Rrs5 (total airway resistance), Rrs5-20 (peripheral airway resistance), FeNO, and symptoms by the C-ACT', 'Spirometry and impulse oscillation system (IOS) measurements', 'fractional exhaled nitric oxide (FeNO), and the childhood asthma control test (C-ACT', 'prebronchodilator (pre-) FEV 1  /FVC', 'pre-FEV 1  /FVC', 'bronchodilator response (BDR) in FEV 1']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1960046', 'cui_str': 'Mild persistent asthma'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0595726', 'cui_str': 'Leukotriene receptor antagonist'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0595726', 'cui_str': 'Leukotriene receptor antagonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]","[{'cui': 'C0232024', 'cui_str': 'Total airway resistance'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C1272570', 'cui_str': 'Test control'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}]",30.0,0.269106,(P = 0.113) and FEV 1  (P = 0.109) from baseline to post-treatment did not differ significantly between the placebo and montelukast groups.,"[{'ForeName': 'Ju Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Departments of Pediatrics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, 13496, Korea.'}, {'ForeName': 'Shinhae', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Departments of Pediatrics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, 13496, Korea.'}, {'ForeName': 'Youn Ho', 'Initials': 'YH', 'LastName': 'Shin', 'Affiliation': 'Department of Pediatrics, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, 06135, Korea.'}, {'ForeName': 'Eun Kyo', 'Initials': 'EK', 'LastName': 'Ha', 'Affiliation': 'Department of pediatrics, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seung Won', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Data Science, Sejong University College of Software Convergence, Seoul, Korea.'}, {'ForeName': 'Mi Ae', 'Initials': 'MA', 'LastName': 'Kim', 'Affiliation': 'Departments of Internal Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, 13496, Korea.'}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Yoon', 'Affiliation': 'Department of Pediatrics, Myongji Hospital, Seonam University College of Medicine, Goyang, Republic of Korea.'}, {'ForeName': 'Hey Sung', 'Initials': 'HS', 'LastName': 'Baek', 'Affiliation': 'Department of Pediatrics, Kandong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sun Hee', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, Kyung Hee University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong Man', 'Initials': 'YM', 'LastName': 'Han', 'Affiliation': 'Departments of Pediatrics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, 13496, Korea.'}]",Pediatric pulmonology,['10.1002/ppul.25085']
2563,32960626,"Effects of a low-carbohydrate diet on body composition and performance in road cycling: a randomized, controlled trial.","Low-carbohydrate diets are frequently used to improve performance in endurance sports, often with contradictory results. This study aimed to assess whether a low-carbohydrate diet can outperform an isocaloric conventional diet for improving body composition and performance in a sample of twenty-six trained male road cyclists (previous experience in cyclosportive events, 7.6 ± 4.4 years; age, 26.9 ± 4.9 years; weekly training volume, 7.8 ± 2.9 hours; height, 176 ± 7 centimeters; body fat percentage, 9.7 ± 0.8 %; weight, 65.3 ± 2.3 kg). Detraining and pretreatment periods in which nutrition and training were standardized were followed by an eight-week long intervention in which cyclists consumed either a low-carbohydrate diet (15 % of calories from carbohydrates) or a conventional endurance sports diet while maintaining the same training volumes and intensities. Body composition was assessed through electrical impedance, and performance was evaluated through a twenty-minute time trial performed on a smart bike trainer. The results revealed an overall improvement over time in absolute and relative power, body mass, and body fat for both groups, whilst the improvement in absolute power was comparable. The improvements seen in relative power (p = 0.042), body mass (p = 0.006), and body fat (p = 0.01) were significantly higher in the low-carbohydrate group. We concluded that eight weeks of a low-carbohydrate diet significantly reduced body weight and body fat percentage, and improved 20-minute relative power values in a sample of road cyclists when compared to an isocaloric conventional diet.",2020,"The improvements seen in relative power (p = 0.042), body mass (p = 0.006), and body fat (p = 0.01) were significantly higher in the low-carbohydrate group.","['road cycling', 'a sample of twenty-six trained male road cyclists (previous experience in cyclosportive events, 7.6 ± 4.4 years; age, 26.9 ± 4.9 years; weekly training volume, 7.8 ± 2.9 hours; height, 176 ± 7 centimeters; body fat percentage, 9.7 ± 0.8 %; weight, 65.3 ± 2.3 kg']","['low-carbohydrate diet', 'isocaloric conventional diet', 'Detraining and pretreatment periods in which nutrition and training were standardized were followed by an eight-week long intervention in which cyclists consumed either a low-carbohydrate diet (15 % of calories from carbohydrates) or a conventional endurance sports diet', 'Low-carbohydrate diets']","['relative power', 'body composition and performance', 'body fat', 'Body composition', 'body weight and body fat percentage', 'body mass', 'overall improvement over time in absolute and relative power, body mass, and body fat']","[{'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",26.0,0.017905,"The improvements seen in relative power (p = 0.042), body mass (p = 0.006), and body fat (p = 0.01) were significantly higher in the low-carbohydrate group.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Sitko', 'Affiliation': 'Facultad de Ciencias de la Salud y del Deporte. Universidad de Zaragoza.'}, {'ForeName': 'Rafel', 'Initials': 'R', 'LastName': 'Cirer-Sastre', 'Affiliation': ""Institut Nacional d'Educació Física de Catalunya (INEFC). Universitat de Lleida (UdL).""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Corbi', 'Affiliation': ""Institut Nacional d'Educació Física de Catalunya (INEFC). Universitat de Lleida (UdL).""}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'López Laval', 'Affiliation': 'Facultad de Ciencias de la Salud y del Deporte. Universidad de Zaragoza.'}]",Nutricion hospitalaria,['10.20960/nh.03103']
2564,32960643,"Short-term branched-chain amino acid supplementation does not enhance vertical jump in professional volleyball players. A double-blind, controlled, randomized study.","To the best of the authors' knowledge, no previous studies have described the effect of branched-chain amino acids (BCAA) on vertical performance during a week in professional volleyball players. This study assessed BCAA supplementation for a week, aiming to improve vertical jump performance in male professional volleyball players. Twelve male volleyballers were randomly assigned to a BCAA group (n = 6) or a control group (n = 6). The BCAA group ingested 21 g over a week, 7 g per day on Monday, Wednesday, and Friday, before a volleyball training session, while the control group drank a placebo drink. Participants performed 8 maximal countermovement jumps (CMJ); the 3 CMJs on Monday and Wednesday were evaluated after warm-up, after plyometric training, and at the end of the training session; and the 2 CMJs on Friday were evaluated after warm-up, and at the end of the training session. Compared with baseline, significant differences in CMJ over the week were seen neither in the BCAA group (p < 0.000; SE = 0.31) nor between groups. The results indicated that 21 g of BCAA supplementation over a week did not improve vertical jump performance in professional volleyball players.",2020,"Compared with baseline, significant differences in CMJ over the week were seen neither in the BCAA group (p < 0.000; SE = 0.31) nor between groups.","['Twelve male volleyballers', 'male professional volleyball players', 'professional volleyball players']","['control group drank a placebo drink', 'branched-chain amino acids (BCAA', 'BCAA supplementation', 'Short-term branched-chain amino acid supplementation', 'BCAA']","['vertical jump performance', 'CMJ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0556085', 'cui_str': 'Branched chain amino acid supplementation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",12.0,0.0458344,"Compared with baseline, significant differences in CMJ over the week were seen neither in the BCAA group (p < 0.000; SE = 0.31) nor between groups.","[{'ForeName': 'Juan Pedro', 'Initials': 'JP', 'LastName': 'Martín-Martínez', 'Affiliation': 'Facultad Ciencias del Deporte. Universidad de Extremadura.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Calleja Gonzalez', 'Affiliation': 'Facultad Ciencias del Deporte. Universidad de Extremadura.'}, {'ForeName': 'José Carmelo', 'Initials': 'JC', 'LastName': 'Adsuar Sala', 'Affiliation': 'Facultad Ciencias del Deporte. Universidad de Extremadura.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Gómez-Pomares', 'Affiliation': 'Facultad Ciencias del Deporte. Universidad de Extremadura.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Carlos-Vivas', 'Affiliation': 'Facultad Ciencias del Deporte. Universidad de Extremadura.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pérez-Gómez', 'Affiliation': 'Facultad Ciencias del Deporte. Universidad de Extremadura.'}]",Nutricion hospitalaria,['10.20960/nh.03032']
2565,32960651,"Effects of the Anti-stigma Workplace Intervention ""Working Mind"" in a Canadian Health-Care Setting: A Cluster-Randomized Trial of Immediate Versus Delayed Implementation: Effets d'une intervention en milieu de travail anti-stigmates, l'Esprit au travail, dans un milieu canadien de soins de santé: un essai randomisé en grappes d'une mise en œuvre immédiate plutôt que reportée.","OBJECTIVES


The Working Mind is a program designed to reduce stigmatizing attitudes toward mental illness, improve resilience, and promote mental health in the general workplace. Previous research has revealed positive program effects in a variety of workplace settings. This study advances previous work in implementing randomization and a control group to assess the intervention's efficacy.
METHODS


The program was evaluated using a cluster-randomized design, with pretest, posttest, and a 3-month follow-up in 2 implementation groups across 4 sites.
RESULTS


The Working Mind program was effective at decreasing mental health stigma and increasing self-reported resilience and coping skills at the pre-post assessment in both delivery groups. The program's effects were maintained to the time of 3-month follow-up. Qualitative data provided further evidence that participants benefited from the program.
CONCLUSIONS


This study represents an advancement over past research and provides further support for efficacy of the Working Mind program. Directions for future research, including replication using rigorous methodological procedures and examination of program effects over longer follow-up intervals, are discussed.",2020,The Working Mind program was effective at decreasing mental health stigma and increasing self-reported resilience and coping skills at the pre-post assessment in both delivery groups.,['Canadian Health-Care Setting'],"['Immediate Versus Delayed Implementation', ""d'une intervention en milieu de travail anti-stigmates, l'Esprit au travail, dans un milieu canadien de soins de santé: un essai randomisé en grappes d'une mise en œuvre immédiate plutôt que reportée"", 'Anti-stigma Workplace Intervention ""Working Mind']",['mental health stigma and increasing self-reported resilience and coping skills'],"[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}]",,0.0194142,The Working Mind program was effective at decreasing mental health stigma and increasing self-reported resilience and coping skills at the pre-post assessment in both delivery groups.,"[{'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Dobson', 'Affiliation': 'University of Calgary, Alberta, Canada.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Markova', 'Affiliation': 'University of Calgary, Alberta, Canada.'}, {'ForeName': 'Alainna', 'Initials': 'A', 'LastName': 'Wen', 'Affiliation': 'University of Notre Dame, IN, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Smith', 'Affiliation': 'Nova Scotia Health Authority, NS, USA.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743720961738']
2566,32960658,"The relation between the placebo response, observed treatment effect, and failure to meet primary endpoint: A systematic review of clinical trials of preventative pharmacological migraine treatments.","OBJECTIVE


To evaluate the association between the degree of response to placebo in migraine studies and the observed difference between drug and placebo across studies of preventative treatments for migraine.
METHODS


A systematic review was performed using MEDLINE and the Cochrane Central Register of Controlled Clinical Trials from January 1988 to June 2019. Randomized, double-blind, parallel-group, placebo-controlled trials on oral or injection preventative treatments for migraine were included. Single- and multi-variable linear regression analyses were performed on the placebo-subtracted response rate (i.e. placebo responders subtracted from active responders), and the proportion of placebo responders. Fisher's exact tests were performed on the level of placebo response and the success in meeting the study's primary endpoint.
RESULTS


After adjusting for route of administration and number of randomized subjects, there was a statistically significant association between the proportion of patients who were placebo responders and the placebo-subtracted response rate (b = -0.27,  p  = 0.02). There was a statistically significant difference in trial success rate (60%) between studies with ≤20% placebo responders and studies with > 30% placebo responders ( p  = 0.03).
CONCLUSION


Considering the detrimental impact that high placebo response can have on clinical trials, it is imperative to find effective solutions to decrease the placebo response and increase assay sensitivity.",2020,"There was a statistically significant difference in trial success rate (60%) between studies with ≤20% placebo responders and studies with > 30% placebo responders ( p  = 0.03).
",['January 1988 to June 2019'],['placebo'],"['trial success rate', 'placebo-subtracted response rate']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1719767', 'cui_str': 'Subtract - dosing instruction fragment'}]",,0.464192,"There was a statistically significant difference in trial success rate (60%) between studies with ≤20% placebo responders and studies with > 30% placebo responders ( p  = 0.03).
","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Evans', 'Affiliation': 'WCG Analgesic Solutions, Wayland, MA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Romero', 'Affiliation': 'Boston Headache Institute, PainCare, Waltham, MA, USA.'}, {'ForeName': 'Egilius Lh', 'Initials': 'EL', 'LastName': 'Spierings', 'Affiliation': 'Boston Headache Institute, PainCare, Waltham, MA, USA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Katz', 'Affiliation': 'WCG Analgesic Solutions, Wayland, MA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420960020']
2567,32960662,Randomized clinical trial on 7-days-a-week postoperative radiotherapy vs. concurrent postoperative radio-chemotherapy in locally advanced cancer of the oral cavity/oropharynx.,"OBJECTIVE


To compare the efficacy and tolerance of 7-days-a-week accelerated postoperative radiotherapy (p-CAIR)  vs  postoperative radio-chemotherapy (p-RTCT).
METHODS


Between September 2007 and October 2013 111 patients were enrolled and randomly assigned to receive 63 Gy in 1.8 Gy fractions 7-days-a-week ( n  = 57, p-CAIR) or 63 Gy in 1.8 Gy fractions 5-days-a-week with concurrent cisplatin 80-100 mg per square meter of body-surface area on days 1, 22 and 43 of the radiotherapy course (p-RTCT). It represents approximately 40% of the intended trial size, that was closed prematurely due to slowing accrual. Only high-risk patients with squamous cell cancer of the oropharynx/oral cavity, considered fit for concurrent treatment were enrolled.
RESULTS


The rate of locoregional control (LRC) did not differ significantly between treatment arms ( p  = 0.18, HR = 0.56), 5 year LRC tended, however, to favour p-RTCT (81%)  vs  p-CAIR (62%). There was no difference in overall survival between treatment arms ( p  = 0.90, HR = 1.03).The incidence and severity of acute mucosal reactions and late reactions did not differ significantly between treatment arms. Haematological toxicity of p-RTCT was, however, considerably increased compared to p-CAIR.
CONCLUSION


Concurrent postoperative RTCT tended to improve locoregional control rate as compared to p-CAIR. This, however, did not transferred into improved overall survival. Postoperative RTCT was associated with a substantial increase in haematological toxicity that negatively affected treatment compliance in this arm.
ADVANCES IN KNOWLEDGE


To our knowledge this is the first trial that compares accelerated radiotherapy and radio-chemotherapy in postoperative treatment for oralcavity/oropharyngeal cancer.",2020,"There was no difference in overall survival between treatment arms ( p  = 0.90, HR = 1.03).The incidence and severity of acute mucosal reactions and late reactions did not differ significantly between treatment arms.","['oralcavity/oropharyngeal cancer', 'locally advanced cancer of the oral cavity/oropharynx', 'Between September 2007 and', 'Only high-risk patients with squamous cell cancer of the oropharynx/oral cavity, considered fit for concurrent treatment were enrolled', 'October 2013 111 patients']","['63\u2009Gy in 1.8\u2009Gy fractions 5-days-a-week with concurrent cisplatin', '7-days-a-week postoperative radiotherapy vs. concurrent postoperative radio-chemotherapy', 'radiotherapy and radio-chemotherapy', '7-days-a-week accelerated postoperative radiotherapy (p-CAIR)  vs  postoperative radio-chemotherapy (p-RTCT']","['locoregional control rate', 'severity of acute mucosal reactions and late reactions', 'rate of locoregional control (LRC', 'Haematological toxicity', 'haematological toxicity', 'overall survival']","[{'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0054732', 'cui_str': 'carboxyaminoimidazole ribotide'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",111.0,0.103538,"There was no difference in overall survival between treatment arms ( p  = 0.90, HR = 1.03).The incidence and severity of acute mucosal reactions and late reactions did not differ significantly between treatment arms.","[{'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Wozniak', 'Affiliation': 'Department of Radiation Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Misiołek', 'Affiliation': 'Department of Laryngology, Silesian Medical University, Katowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Idasiak', 'Affiliation': 'Radiotherapy Clinic and Teaching Hospital, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Dębosz-Suwińska', 'Affiliation': 'Department of Radiation Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Jaworska', 'Affiliation': 'Department of Pathology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Wieslaw', 'Initials': 'W', 'LastName': 'Bal', 'Affiliation': 'Department of Chemotherapy, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Boguslaw', 'Initials': 'B', 'LastName': 'Maciejewski', 'Affiliation': 'Department of Radiation Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Leszek', 'Initials': 'L', 'LastName': 'Miszczyk', 'Affiliation': 'Department of Radiation Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Składowski', 'Affiliation': 'Radiotherapy Clinic and Teaching Hospital, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Suwinski', 'Affiliation': 'Radiotherapy Clinic and Teaching Hospital, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, Poland.'}]",The British journal of radiology,['10.1259/bjr.20200288']
2568,32960669,Evaluation of a Tube Voltage-Tailored Contrast Medium Injection Protocol for Coronary CT Angiography: Results From the Prospective VOLCANIC Study.,"OBJECTIVE.  The purpose of this study was to prospectively evaluate, using software support, the feasibility and the quantitative and qualitative image quality parameters of a tube voltage-tailored contrast medium (CM) application protocol for patient-specific injection during coronary CT angiography (CCTA).  SUBJECTS AND METHODS.  In the Voltage-Based Contrast Media Adaptation in Coronary Computed Tomography Angiography (VOLCANIC-CTA) study, a single-center trial, 120 patients referred for CCTA were prospectively assigned to a tube voltage-tailored CM injection protocol. Automated tube voltage levels were selected in 10-kV intervals and ranged from 70 to 130 kV, and the iodine delivery rate (IDR) was adapted to the tube voltage level using dedicated software. The administered CM volume (370 mg I/mL) ranged from 33 mL at 70 kV (IDR, 0.7 g I/s) to 65 mL at 130 kV (IDR, 1.7 g I/s). Attenuation was measured in the aorta and coronary arteries to calculate quantitative signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), and 5-point scales were used to evaluate overall image quality. Radiation metrics were also assessed and compared among the protocols.  RESULTS.  The mean age of the study patients was 62.5 ± 11.9 (SD) years. Image quality was rated as diagnostic in all patients. Contrast attenuation peaked at 70 kV ( p  < 0.001), whereas SNR and CNR parameters showed no significant differences between tube voltage levels ( p  ≥ 0.085). Additionally, no significant differences in subjective image quality parameters were found among the different protocols ( p  ≥ 0.139). The lowest radiation dose values were observed in the group assigned to the 70-kV protocol, which had a median radiation effective dose of 2.0 mSv ( p  < 0.001).  CONCLUSION.  The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.",2020,The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.,"['The mean age of the study patients was 62.5 ± 11.9 (SD) years', 'Coronary CT Angiography', 'patient-specific injection during coronary CT angiography (CCTA', '120 patients referred for CCTA']","['tube voltage-tailored contrast medium (CM) application protocol', 'tube voltage-tailored CM injection protocol', 'Tube Voltage-Tailored Contrast Medium Injection Protocol']","['quantitative signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), and 5-point scales', 'Radiation metrics', 'Image quality', 'subjective image quality parameters', 'lowest radiation dose values', 'tube voltage levels', 'iodine delivery rate (IDR']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",120.0,0.0253303,The proposed tube voltage-tailored injection protocol allows individualized scanning of patients undergoing CCTA and significantly reduces CM and radiation dose while maintaining a high diagnostic image quality.,"[{'ForeName': 'Simon S', 'Initials': 'SS', 'LastName': 'Martin', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Dante A', 'Initials': 'DA', 'LastName': 'Giovagnoli', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Andres F', 'Initials': 'AF', 'LastName': 'Abadia', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Vingiani', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Philipp L von Knebel', 'Initials': 'PLVK', 'LastName': 'Doeberitz', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Hubert E', 'Initials': 'HE', 'LastName': 'Smith', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Fischer', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Varga-Szemes', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Vogl', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Carlo N De', 'Initials': 'CN', 'LastName': 'Cecco', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'U Joseph', 'Initials': 'UJ', 'LastName': 'Schoepf', 'Affiliation': 'Department of Radiology and Radiological Science, Division of Cardiovascular Imaging, Medical University of South Carolina, Charleston, SC.'}]",AJR. American journal of roentgenology,['10.2214/AJR.20.22777']
2569,32960673,A preoperative radiomics model for the identification of lymph node metastasis in patients with Early-stage cervical squamous cell carcinoma.,"OBJECTIVES


To develop and validate a radiomics modelfor preoperative identification of lymph node metastasis (LNM) in patients with early-stage cervical squamous cell carcinoma (CSCC).
METHODS


Total of 190 eligible patients were randomly divided intotraining( n  = 100) andvalidation ( n  = 90) cohorts. Handcrafted features and deep-learning features were extracted from  T 2 -weighted fat suppressionimages. The minimum redundancy maximum relevancealgorithm and LASSO regression with 10-fold cross-validation were used for key features selection. A radiomics model that incorporated the handcrafted-signature, deep-signature and squamous cell carcinoma antigen (SCC-Ag) levels was developed by logistic regression. The modelperformance was assessed and validatedwith respect to its calibration, discrimination and clinical usefulness.
RESULTS


Three handcrafted features and three deep-learning features were selected and used to build handcrafted- and deep-signature. The model, which incorporated the handcrafted-signature, deep-signature and SCC-Ag showed satisfactory calibration and discrimination in the training cohort (AUC: 0.852, 95% CI: 0.761-0.943) and the validation cohort (AUC: 0.815, 95% CI: 0.711-0.919). Decision curve analysis indicated the clinical usefulness of the radiomics model. The radiomics model yielded greater AUCs than either the radiomics signature (AUC = 0.806 and 0.779, respectively) or the SCC-Ag (AUC = 0.735 and 0.688, respectively) alone in both the training andvalidation cohorts.
CONCLUSION


The presented radiomics model can be used for preoperative identification of LNM inpatientswith early-stage CSCC. Its performance outperforms that ofSCC-Ag level analysis alone.
ADVANCES IN KNOWLEDGE


A radiomics model incorporated radiomics signature and SCC-Ag levels demonstrated good performance in identifying LNM in patientswithearly-stage CSCC.",2020,"The radiomics model yielded greater AUCs than either the radiomics signature (AUC = 0.806 and 0.779, respectively) or the SCC-Ag (AUC = 0.735 and 0.688, respectively) alone in both the training andvalidation cohorts.
","['patients with Early-stage cervical squamous cell carcinoma', 'Total of 190 eligible patients were randomly divided intotraining( n  = 100) andvalidation ( n  = 90) cohorts', 'patients with early-stage cervical squamous cell carcinoma (CSCC']",[],"['handcrafted-signature, deep-signature and squamous cell carcinoma antigen (SCC-Ag) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0279671', 'cui_str': 'Squamous cell carcinoma of cervix'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0075091', 'cui_str': 'Squamous cell carcinoma antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",190.0,0.027531,"The radiomics model yielded greater AUCs than either the radiomics signature (AUC = 0.806 and 0.779, respectively) or the SCC-Ag (AUC = 0.735 and 0.688, respectively) alone in both the training andvalidation cohorts.
","[{'ForeName': 'Lifen', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'The Second School of Clinical Medical, Southern Medical University, 1023 Shatai Nan Road, Baiyun District, Guangzhou 510515, Guangdong, China.'}, {'ForeName': 'Huasheng', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Ruichun', 'Initials': 'R', 'LastName': 'Long', 'Affiliation': ""Department of anesthesiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Haotian', 'Initials': 'H', 'LastName': 'Xia', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Jinglei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, 106 ZhongshanEr Road, Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Zaiyi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'The Second School of Clinical Medical, Southern Medical University, 1023 Shatai Nan Road, Baiyun District, Guangzhou 510515, Guangdong, China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'The Second School of Clinical Medical, Southern Medical University, 1023 Shatai Nan Road, Baiyun District, Guangzhou 510515, Guangdong, China.'}]",The British journal of radiology,['10.1259/bjr.20200358']
2570,32960684,Re: Bipolar Vaporization of the Prostate May Cause Higher Complication Rates Compared to Bipolar Loop Resection: A Randomized Prospective Trial.,,2020,,[],['Bipolar Loop Resection'],[],[],"[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",[],,0.0361977,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001268.02']
2571,32960716,Re: Effect of Water Composition and Timing of Ingestion on Urinary Lithogenic Profile in Healthy Volunteers: A Randomized Crossover Trial.,,2020,,['Healthy Volunteers'],['Water Composition and Timing of Ingestion'],['Urinary Lithogenic Profile'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",[],,0.0487953,,"[{'ForeName': 'Dean G', 'Initials': 'DG', 'LastName': 'Assimos', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001280.01']
2572,32960827,"Oral Glutathione and Growth in Cystic Fibrosis: A Multi-Center, Randomized, Placebo-Controlled, Double-Blind Trial.","OBJECTIVES


The nutritional status of children with cystic fibrosis (CF) is associated with mortality and morbidity. Intestinal inflammation may contribute to impaired digestion, absorption and nutrient utilization in patients with CF and oral glutathione may reduce inflammation, promoting improved nutritional status in patients with CF.
METHODS


The GROW study was a prospective, multi-center, randomized, placebo-controlled, double-blind, Phase II clinical trial in pancreatic insufficient patients with CF between the ages of 2-10 years. Patients received reduced glutathione or placebo orally daily for 24 weeks. The primary endpoint was the difference in change in weight-for-age z-scores from baseline through week 24 between treatment groups. Secondary endpoints included other anthropometrics, serum and fecal inflammatory markers in addition to other clinical outcomes.
RESULTS


58 participants completed the study. No significant differences were seen between glutathione (n = 30) and placebo (n = 28) groups in the 6 month change in weight-for-age z-score (-0.08; 95% CI: -0.22, 0.06; p = 0.25); absolute change in weight (kg) (-0.18; 95% CI: -0.55, 0.20; p = 0.35); or absolute change in BMI kg/m (-0.06; 95% CI: -0.37, 0.25; p = 0.69). There were no significant differences in other secondary endpoints. Overall, glutathione was safe and well tolerated.
CONCLUSIONS


Oral glutathione supplementation did not impact growth or change serum or fecal inflammatory markers in pancreatic insufficient children with CF when compared to placebo.",2020,"No significant differences were seen between glutathione (n = 30) and placebo (n = 28) groups in the 6 month change in weight-for-age z-score (-0.08; 95% CI: -0.22, 0.06; p = 0.25); absolute change in weight (kg) (-0.18; 95% CI: -0.55, 0.20; p = 0.35); or absolute change in BMI kg/m","['58 participants completed the study', 'children with cystic fibrosis (CF', 'Cystic Fibrosis', 'pancreatic insufficient children with CF', 'pancreatic insufficient patients with CF between the ages of 2-10 years']","['Oral glutathione supplementation', 'placebo', 'Oral Glutathione', 'reduced glutathione or placebo', 'Placebo']","['Overall, glutathione was safe and well tolerated', 'change in weight-for-age z-scores', 'impact growth or change serum or fecal inflammatory markers', 'anthropometrics, serum and fecal inflammatory markers in addition to other clinical outcomes', 'mortality and morbidity']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",58.0,0.571257,"No significant differences were seen between glutathione (n = 30) and placebo (n = 28) groups in the 6 month change in weight-for-age z-score (-0.08; 95% CI: -0.22, 0.06; p = 0.25); absolute change in weight (kg) (-0.18; 95% CI: -0.55, 0.20; p = 0.35); or absolute change in BMI kg/m","[{'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Bozic', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Christopher H', 'Initials': 'CH', 'LastName': 'Goss', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Rabindra M', 'Initials': 'RM', 'LastName': 'Tirouvanziam', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Baines', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kloster', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Liebe', 'Initials': 'L', 'LastName': 'Antoine', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Drucy', 'Initials': 'D', 'LastName': 'Borowitz', 'Affiliation': 'Cystic Fibrosis Foundation, Bethesda, Maryland.'}, {'ForeName': 'Sarah Jane', 'Initials': 'SJ', 'LastName': 'Schwarzenberg', 'Affiliation': ""University of Minnesota Masonic Children's Hospital, Minneapolis, Minnesota.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002948']
2573,32960955,Physiotherapy in addition to vacuum bell therapy in patients with pectus excavatum.,"OBJECTIVES


Vacuum bell and exercise therapy are non-invasive treatments for pectus excavatum (PE). The purpose of this study was to determine the effects of the physiotherapy programme applied in addition to vacuum bell treatment in patients with PE.
METHODS


The study included 26 male patients with PE aged 11-18 years. Patients were randomly divided into 2 groups: group 1 received only vacuum bell treatment; group 2 had vacuum bell therapy and physiotherapy. Patient demographic and disease-related characteristics, type of sternal depression, perception of their deformity, postural evaluations, treatment satisfaction and quality of life were evaluated before and 12 weeks after treatment.
RESULTS


From external chest circumference measurements related to PE, sternal depression and anthropometric index values showed improvement in both groups (P < 0.05), but better results were observed in group 2 than in group 1 (P < 0.05). Modified percent depth and scores from the T3 region (distance between the most prominent point of the sternum and the spinous process of the vertebra at the same level) showed improvement only in group 2 (P < 0.01), whereas severity of PE, the patient's perception of his deformity and parental physiological quality-of-life scores improved in both groups (P < 0.05). Posture, satisfaction with treatment and the patients' physiological quality-of-life scores were significantly better in group 2 (P < 0.05).
CONCLUSIONS


Due to the additional improvements and greater satisfaction in the group receiving physiotherapy, we think that a proper rehabilitation programme should be applied simultaneously with the vacuum bell treatment in patients with PE.
CLINICAL TRIAL REGISTRATION: CLINICALTRIALS.GOV


NCT04167865.",2020,"Posture, satisfaction with treatment and the patients' physiological quality-of-life scores were significantly better in group 2 (P < 0.05).
","['patients with PE', '26 male patients with PE aged 11-18\u2009years', 'patients with PE.\nMETHODS', 'patients with pectus excavatum']","['physiotherapy', 'Physiotherapy', 'vacuum bell treatment; group 2 had vacuum bell therapy and physiotherapy', 'physiotherapy programme', 'Vacuum bell and exercise therapy']","['Patient demographic and disease-related characteristics, type of sternal depression, perception of their deformity, postural evaluations, treatment satisfaction and quality of life', ""severity of PE, the patient's perception of his deformity and parental physiological quality-of-life scores"", 'PE, sternal depression and anthropometric index values', 'physiological quality-of-life scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016842', 'cui_str': 'Congenital pectus excavatum'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1699693', 'cui_str': 'Sternal depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0016842', 'cui_str': 'Congenital pectus excavatum'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",26.0,0.0613133,"Posture, satisfaction with treatment and the patients' physiological quality-of-life scores were significantly better in group 2 (P < 0.05).
","[{'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Ihsan', 'Initials': 'I', 'LastName': 'Alaca', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Yüksel', 'Affiliation': 'Chest Wall Deformities and Pectus Association, Istanbul, Turkey.'}]",Interactive cardiovascular and thoracic surgery,['10.1093/icvts/ivaa161']
2574,32960998,"Performance, acceptability, and validation of a phone application bowel diary.","AIMS


To assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary).
METHODS


Women reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice-daily phone notifications. Women were randomized to complete up to three consecutive 14-day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test-retest reliability was assessed with intraclass correlations (ICCs).
RESULTS


Paired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to-strongly correlated for BMs per week (r = .61), urgency BMs per week (r = .76), FIE per week (r = .66), urgency FIE per week (r = .72). Test-retest reliability was good (ICC = .81 BMs per week, .79 urgency BMs per week, .74 FIE per week, and .62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0-100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper.
CONCLUSION


The PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real-time diary completion that obviated staff data entry.",2020,Test-retest reliability was good,['Women reporting refractory accidental bowel leakage (ABL'],['phone application electronic bowel diary (PFDN Bowel eDiary'],"['Diary events', 'System usability scale (SUS) assessed eDiary usability', 'Performance, acceptability, and validation of a phone application bowel diary', 'urgency BMs per week ', 'performance, acceptability, external validity, and reliability', 'presence or absence of urgency and Bristol stool scale consistency', 'bowel movements (BM) and fecal incontinence episodes (FIE', 'mean SUS score', 'urgency FIE']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0331857,Test-retest reliability was good,"[{'ForeName': 'Halina M', 'Initials': 'HM', 'LastName': 'Zyczynski', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh/Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': ""Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women's and Infants Hospital, Providence, Rhode Island, USA.""}, {'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Arya', 'Affiliation': 'Department of Obstetrics and Gynecology, Hospital of University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Department of Reproductive Medicine, UC San Diego Health Care System, San Diego, California, USA.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Rahn', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Durham, NC, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurourology and urodynamics,['10.1002/nau.24520']
2575,32960999,"Which combination is most effective in women with idiopathic overactive bladder, including bladder training, biofeedback, and electrical stimulation? A prospective randomized controlled trial.","OBJECTIVE


To evaluate the efficacy of single and combined use of biofeedback (BF) and electrical stimulation (ES) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB).
MATERIAL AND METHODS


Seventy women were randomized into four groups as follows: Group 1 received BT alone (n = 18), Group 2 received BT + BF (n = 17), Group 3 received BT + ES (n = 18), and Group 4 received BT + BF + ES (n = 17). BF and ES were performed 3 days a week, 20 min a day, a total of 24 sessions for 8 weeks. All women were evaluated in terms of incontinence severity (pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and number of pads), QoL (incontinence impact questionnaire), treatment success (positive response rate), cure/improvement rate, treatment satisfaction (Likert scale), and discomfort level (visual analog scale).
RESULTS


At the end of the treatment, severity of incontinence, frequency of voiding, incontinence episodes, and treatment satisfaction significantly improved in Group 3 and Group 4 compared with the other two groups. In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2. In Group 2 and Group 3, statistically significant improvements were seen in nocturia and QoL compared with Group 1. Moreover, statistically significant improvements in nocturia and QoL were found in Group 4 compared with the other three groups. There was no difference in the discomfort level of application between the groups.
CONCLUSION


We conclude that in the first-line conservative treatment of women with idiopathic OAB: (i) adding BF and/or ES to BT increases treatment effectiveness, (ii) clinical efficiency is greater when the combination includes ES, (iii) BT + BF + ES (triple combination) is the most effective treatment option in reducing nocturia and improving QoL.",2020,"In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2.","['women with idiopathic overactive bladder', 'women with idiopathic overactive bladder (OAB', 'women with idiopathic OAB', 'Seventy women were randomized into four groups as follows']","['biofeedback (BF) and electrical stimulation (ES) added to bladder training (BT', 'BT\xa0+\xa0BF', 'BT + BF + ES', 'BT alone', 'BT\xa0+\xa0ES']","['nocturia and QoL', 'severity of incontinence, frequency of voiding, incontinence episodes, and treatment satisfaction', 'nocturia and improving QoL', 'incontinence severity (pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and number of pads), QoL (incontinence impact questionnaire), treatment success (positive response rate), cure/improvement rate, treatment satisfaction (Likert scale), and discomfort level (visual analog scale', 'discomfort level of application', 'incontinence-related quality of life (QoL', 'cure/improvement and positive response rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0150474', 'cui_str': 'Urinary bladder training'}]","[{'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",70.0,0.0805382,"In Group 3 and Group 4, high statistically significant values were found in cure/improvement and positive response rates as opposed to Group 1 and Group 2.","[{'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Firinci', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Necmettin', 'Initials': 'N', 'LastName': 'Yildiz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Alkan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Zafer', 'Initials': 'Z', 'LastName': 'Aybek', 'Affiliation': 'Department of Urology, Faculty of Medicine, Pamukkale University, Denizli, Turkey.'}]",Neurourology and urodynamics,['10.1002/nau.24522']
2576,32961034,Thorough QT/QTc Study Evaluating the Effect of Macimorelin on Cardiac Safety Parameters in Healthy Participants.,"Macimorelin is an orally active growth hormone secretagogue indicated for the diagnosis of adult growth hormone deficiency. The primary objective of this study was to evaluate the effect of macimorelin on the baseline and placebo-corrected mean QT interval using Fridericia's formula (ΔΔQTcF). Secondary objectives were to determine QTcF for moxifloxacin; evaluate the effects of macimorelin on other cardiac intervals (PR, QRS, RR), heart rate, and electrocardiogram morphology parameters; characterize pharmacokinetics; and assess safety of macimorelin. The phase 1 thorough QT/QTc study, designed according to the International Council for Harmonisation E14 guideline, was a randomized, placebo-controlled, double-blind, 3-way complete crossover study comparing the effect of macimorelin 2.0 mg/kg with placebo and moxifloxacin 400 mg (positive control). Data were collected over a 3-month span from male (n=36) and female participants (n=24) aged 18 to 55 years with body mass index between 18.5 and 30.0 kg/m 2  . Fifty-six participants received all 3 treatments. The ΔΔQTcF for macimorelin showed a prolongation with a maximum mean value of 9.61 milliseconds (2-sided 90% confidence interval, 7.81 milliseconds and 11.41 milliseconds) at 4 hours after dosing. The 2-sided 90% confidence interval of this value also exceeded the 10 millisecond threshold at 3 hours after dosing. Assay sensitivity was confirmed with moxifloxacin. Other electrocardiogram parameters evaluated were not influenced by macimorelin. Macimorelin did not raise other safety concerns and was well tolerated. In summary, a single supratherapeutic dose of macimorelin prolonged cardiac repolarization according to the regulatory guideline.",2020,Macimorelin did not raise other safety concerns and was well tolerated.,"['Data were collected over a 3-month span from male (n=36) and female participants (n=24) aged 18 to 55 years with body mass index between 18.5 and 30.0\xa0kg/m 2  ', 'Healthy Participants']","['moxifloxacin', 'placebo', 'macimorelin 2.0 mg/kg with placebo and moxifloxacin 400\xa0mg (positive control', 'Macimorelin', ""placebo-corrected mean QT interval using Fridericia's formula (ΔΔQTcF"", 'macimorelin']","['Cardiac Safety Parameters', 'cardiac intervals (PR, QRS, RR), heart rate, and electrocardiogram morphology parameters; characterize pharmacokinetics; and assess safety of macimorelin', 'Assay sensitivity', 'tolerated', 'cardiac repolarization']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2986922', 'cui_str': 'macimorelin'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1126029', 'cui_str': 'moxifloxacin 400 MG'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C2986922', 'cui_str': 'macimorelin'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.289537,Macimorelin did not raise other safety concerns and was well tolerated.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lissy', 'Affiliation': 'Nuvisan GmbH, Neu-Ulm, Germany.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Demmel', 'Affiliation': 'Nabios GmbH, Munich, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sachse', 'Affiliation': 'Aeterna Zentaris GmbH, Frankfurt, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Ammer', 'Affiliation': 'Aeterna Zentaris GmbH, Frankfurt, Germany.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Kelepouris', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, New Jersey, USA.'}, {'ForeName': 'Vlady', 'Initials': 'V', 'LastName': 'Ostrow', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, New Jersey, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.872']
2577,32964096,Peer effects in smoking cessation: An instrumental variables analysis of a worksite intervention in Thailand.,"While smoking is widely acknowledged to be a social activity, limited evidence exists on the extent to which friends influence each other during worksite-based tobacco cessation interventions. Drawing on data from adult smokers (N = 1823) in a large, cluster randomized controlled trial in worksites in Thailand, this study examines the presence of social spillovers in the decision to abstain from smoking. We leverage a unique aspect of social network structure in these data-the existence of non-overlapping friendship networks-to address the challenge of isolating the effects of peers on smoking behavior from the confounding effects of endogenous friend selection and bidirectional peer influence. We find that individuals with workplace friends who have abstained from smoking during the trial are significantly more likely to abstain themselves. Instrumental variables estimates suggest that abstinence after 3 and 12 months increases 26 and 32 percentage points, respectively, for each additional workplace friend who abstains. These findings highlight the potential for workplace interventions to use existing social networks to magnify the effect of individual-level behavior change, particularly in low- and middle-income countries where tobacco cessation support tends to be limited.",2020,"Instrumental variables estimates suggest that abstinence after 3 and 12 months increases 26 and 32 percentage points, respectively, for each additional workplace friend who abstains.","['Thailand', 'individuals with workplace friends who have abstained from smoking during the trial', 'smoking cessation', 'adult smokers (N\xa0=\xa01823']",[],[],"[{'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],[],,0.0279978,"Instrumental variables estimates suggest that abstinence after 3 and 12 months increases 26 and 32 percentage points, respectively, for each additional workplace friend who abstains.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lowenstein', 'Affiliation': 'Division of Health Policy and Management, University of California, Berkeley School of Public Health, Berkeley, California, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Dow', 'Affiliation': 'Division of Health Policy and Management, University of California, Berkeley School of Public Health, Berkeley, California, USA.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'White', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies and Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA.'}]",SSM - population health,['10.1016/j.ssmph.2020.100659']
2578,32964124,Acquisition of Procedural Skills in Preregistration Physiotherapy Education Comparing Mental Practice Against No Mental Practice: The Learning of Procedures in Physiotherapy Education Trial - A Development of Concept Study.,"Introduction


Procedural skills are a central element in the education of physiotherapists. Procedural skills relate to the execution of a practical task. An educational intervention, which can be used to support skill acquisition of procedural skills, is mental practice (MP). Several studies have investigated the use of MP or imaging in medical education. This pilot study evaluated the application of MP on the acquisition of procedural skills in physiotherapy education.
Methods


This pilot randomised controlled study recruited a convenience sample of 37 BSc physiotherapy student participants. Two different complex task procedures (transfer and vestibular rehabilitation) were trained during this study. Participants in both the transfer (task procedure 1) and the vestibular rehabilitation (task procedure 2) arm of the study were randomly assigned to either MP or no MP.
Results


For the transfer task, median performance at post-acquisition testing showed a moderate effect size in favour of the group using MP ( r : -0.3), but the findings were not statistically significant ( P : 0.2). Similar results were found for the vestibular rehabilitation task ( r : 0.29;  P : 0.21). In addition, the self-reported confidence was higher in the MP group.
Conclusion


Moderate effect sizes were identified in favour of MP at post-acquisition testing. In addition, the between-group difference was higher than the minimally important difference. The feasibility of the study was high based on quantitative feasibility measures such as the recruitment rate. Both these findings suggest larger well-powered studies should be considered to confirm the findings of this pilot study.",2020,"For the transfer task, median performance at post-acquisition testing showed a moderate effect size in favour of the group using MP ( r : -0.3), but the findings were not statistically significant ( P : 0.2).","['Preregistration Physiotherapy Education', 'Participants in both the transfer (task procedure 1) and the vestibular rehabilitation (task procedure 2) arm of the study', '37 BSc physiotherapy student participants']","['MP or no MP', 'Physiotherapy Education', 'complex task procedures (transfer and vestibular rehabilitation', 'Mental Practice Against No Mental Practice', 'MP']",['vestibular rehabilitation task'],"[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]",37.0,0.0541803,"For the transfer task, median performance at post-acquisition testing showed a moderate effect size in favour of the group using MP ( r : -0.3), but the findings were not statistically significant ( P : 0.2).","[{'ForeName': 'Karl Martin', 'Initials': 'KM', 'LastName': 'Sattelmayer', 'Affiliation': 'Physiotherapy, School of Health Sciences, Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Kavi C', 'Initials': 'KC', 'LastName': 'Jagadamma', 'Affiliation': 'Physiotherapy, School of Health Sciences, Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Hilfiker', 'Affiliation': 'School of Health Sciences, University of Applied Sciences and Arts Western Switzerland Valais (HES-SO Valais-Wallis), Leukerbad, Switzerland.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Baer', 'Affiliation': 'Physiotherapy, School of Health Sciences, Queen Margaret University, Edinburgh, UK.'}]",Journal of medical education and curricular development,['10.1177/2382120520927382']
2579,32964141,Does Visual Speed of Processing Training Improve Health-Related Quality of Life in Assisted and Independent Living Communities?: A Randomized Controlled Trial.,"Background and Objectives


Visual speed of processing training had clinically and statistically significant beneficial effects on health-related quality of life among 2,802 healthy community-dwelling adults aged 65-94 years at 2 and 5 years post-training in the Advanced Cognitive Training for Independent and Vital Elderly randomized controlled trial. We examined whether that effect would be found among older adults in assisted and independent living communities.
Research Design and Methods


We conducted a two-arm, parallel randomized controlled trial stratified by assisted versus independent settings in 31 senior living communities and enrolled 351 adults aged 55-102 years. The targeted intervention dose was 10 hr at baseline with 4-hr boosters at 5 and 11 months. The intervention group received computerized visual speed of processing training, while the attention control group solved computerized crossword puzzles. The health-related quality of life outcomes were the Short-Form 36-item Health Survey's mental and physical component  T  scores. Linear mixed-effect models were used.
Results


Visual speed of processing, assisted living, and their interaction had no clinically or statistically significant effects on the physical component  T  scores. However, visual speed of processing ( p  = .022), assisted living ( p  = .022), and their interaction ( p  = .007) had clinically and statistically significant effects on the mental component  T  scores. The estimated marginal means revealed a small effect-sized positive 2.2 point visual speed of processing training effect in the independent living communities, but a clinically important harmful -4.2 point visual speed of processing training effect in the assisted living communities.
Discussion and Implications


Given the medium-sized harmful effect of visual speed of processing training among those in the assisted living communities, caution is advised when using these two visual speed of processing training modalities in assisted living communities until further research verifies or refutes our findings and the underlying etiological pathways.",2020,"Results


Visual speed of processing, assisted living, and their interaction had no clinically or statistically significant effects on the physical component  T  scores.","['2,802 healthy community-dwelling adults aged 65-94 years at 2 and 5 years post-training in the Advanced Cognitive Training for Independent and Vital Elderly randomized controlled trial', 'older adults in assisted and independent living communities', '31 senior living communities and enrolled 351 adults aged 55-102 years']","['computerized visual speed of processing training, while the attention control group solved computerized crossword puzzles', 'processing training']","['assisted living', 'Visual speed of processing, assisted living', ""Short-Form 36-item Health Survey's mental and physical component  T  scores"", 'visual speed of processing', 'health-related quality of life', 'health-related quality of life outcomes']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021189', 'cui_str': 'Independent Living'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0423995', 'cui_str': 'Puzzled'}, {'cui': 'C0589104', 'cui_str': 'Process training'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",351.0,0.151522,"Results


Visual speed of processing, assisted living, and their interaction had no clinically or statistically significant effects on the physical component  T  scores.","[{'ForeName': 'Fredric D', 'Initials': 'FD', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Health, Management and Policy, College of Public Health, The University of Iowa.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Jones', 'Affiliation': 'Department of Biostatistics, College of Public Health, The University of Iowa.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Dotson', 'Affiliation': 'Department of Community and Behavioral Health, College of Public Health, The University of Iowa.'}]",Innovation in aging,['10.1093/geroni/igaa029']
2580,32964140,A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial.,"Digital health applications (apps) have the potential to improve health behaviors and outcomes. We aimed to examine the effectiveness of a consumer web-based app linked to primary care electronic health records (EHRs). CONNECT was a multicenter randomized controlled trial involving patients with or at risk of cardiovascular disease (CVD) recruited from primary care (Clinical Trial registration ACTRN12613000715774). Intervention participants received an interactive app which was pre-populated and refreshed with EHR risk factor data, diagnoses and, medications. Interactive risk calculators, motivational messages and lifestyle goal tracking were also included. Control group received usual health care. Primary outcome was adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications). Secondary outcomes included attainment of risk factor targets and eHealth literacy. In total, 934 patients were recruited; mean age 67.6 (±8.1) years. At 12 months, the proportion with >80% days covered with recommended medicines was low overall and there was no difference between the groups (32.8% vs. 29.9%; relative risk [RR] 1.07 [95% CI, 0.88-1.20]  p  = 0.49). There was borderline improvement in the proportion meeting BP and LDL targets in intervention vs. control (17.1% vs. 12.1% RR 1.40 [95% CI, 0.97-2.03]  p  = 0.07). The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control,  p  = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control,  p  = 0.02). In conclusion, a consumer app integrated with primary health care EHRs was not effective in increasing medication adherence. Borderline improvements in risk factors and modest behavior changes were observed.",2020,"The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control,  p  = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control,  p  = 0.02).","['934 patients were recruited; mean age 67.6 (±8.1) years', 'patients with or at risk of cardiovascular disease (CVD) recruited from primary care (Clinical Trial registration ACTRN12613000715774']","['interactive app which was pre-populated and refreshed with EHR risk factor data, diagnoses and, medications', 'consumer web-based app linked to primary care electronic health records (EHRs', 'usual health care', 'digital health intervention']","['risk factors and modest behavior changes', 'proportion meeting BP and LDL targets', 'attainment of risk factor targets and eHealth literacy', 'e-health literacy scores', 'adherence to guideline-recommended medications (≥80% of days covered for blood pressure (BP) and statin medications', 'attainment of physical activity targets', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",934.0,0.128827,"The intervention was associated with increased attainment of physical activity targets (87.0% intervention vs. 79.7% control,  p  = 0.02) and e-health literacy scores (72.6% intervention vs. 64.0% control,  p  = 0.02).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Westmead Applied Research Centre, Sydney, NSW Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Coorey', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mulley', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Scaria', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Neubeck', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, Scotland.'}, {'ForeName': 'Nashid', 'Initials': 'N', 'LastName': 'Hafiz', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Westmead Applied Research Centre, Sydney, NSW Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Pitt', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Weir', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Forbes', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, Scotland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Bampi', 'Affiliation': 'Fiona Bampi - Cancer Australia, Australian Government, Sydney, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Coenen', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Enright', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Westmead Applied Research Centre, Sydney, NSW Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Centre for Transplant and Renal Research, Westmead Institute for Medical Research, The University of Sydney, Westmead, NSW Australia.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': 'Centre for Primary Health Care and Equity, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Zwar', 'Affiliation': 'Faculty of Health Sciences & Medicine, Bond University, Gold Coast, QLD Australia.'}, {'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Westmead Applied Research Centre, Sydney, NSW Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rodgers', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Heeley', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Panaretto', 'Affiliation': 'Centre for Chronic Disease, The University of Queensland, Brisbane, QLD Australia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lau', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, Sydney, NSW Australia.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Hayman', 'Affiliation': 'Queensland Health, Brisbane, QLD Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Usherwood', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Westmead Applied Research Centre, Sydney, NSW Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peiris', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, NSW Australia.'}]",NPJ digital medicine,['10.1038/s41746-020-00325-z']
2581,32964166,Randomized controlled trial evaluating a collaborative model of care for transitioning children with medical complexity from hospital to home healthcare: Study protocol.,"This article describes the study protocol for an evaluation of an innovative model of care that supports home health nurses (HHN) who serve children with medical complexity ( CMC). CMC constitute a small proportion of children, but have very high need for health services, are hospitalized frequently, and account for significant proportion of pediatric healthcare expenditures. High-quality home health nursing services are important for CMC, but models of care of home healthcare, after discharge of CMC from the hospital, have not been tested. Our project aims are to develop, implement, and test a model of care, called ICollab, to improve home healthcare delivery for CMC. The ICollab model consists of collaboration between HHN, primary-care physicians and clinicians of the complex care program of a tertiary-care children's hospital in the care of CMC. In this randomized clinical trial, we will recruit 110 CMC discharged home on home health nursing services. The intervention group (n = 55) will receive the ICollab intervention for 6 months post-discharge from the hospital, in addition to usual care. Children in the control group (n = 55) will receive only usual care. Outcome measures will include healthcare utilization metrics (hospitalization rates, emergency room visit rates, and days to readmission), caregiver burden and caregiver satisfaction with home healthcare, HHN retention, and HHN collaboration with other healthcare providers. We hypothesize that ICollab will reduce healthcare utilization and caregiver burden, and improve caregiver satisfaction with home healthcare, increase HHN retention, and increase HHN collaboration with other healthcare providers. Results of this study have the potential to provide a critically needed evidence-base for interventions to improve the quality of healthcare delivery for CMC. This study is registered on clinicaltrials.gov (NCT03978468) and is ongoing.",2020,"Outcome measures will include healthcare utilization metrics (hospitalization rates, emergency room visit rates, and days to readmission), caregiver burden and caregiver satisfaction with home healthcare, HHN retention, and HHN collaboration with other healthcare providers.","['transitioning children with medical complexity from hospital to home healthcare', '110 CMC discharged home on home health nursing services', 'care that supports home health nurses (HHN) who serve children with medical complexity ( CMC']","['ICollab intervention', 'collaborative model of care', 'CMC']","['healthcare utilization metrics (hospitalization rates, emergency room visit rates, and days to readmission), caregiver burden and caregiver satisfaction with home healthcare, HHN retention, and HHN collaboration with other healthcare providers']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3536806', 'cui_str': 'Home Health Care Nursing'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0042799', 'cui_str': 'Home Nurses'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing status'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",110.0,0.0699176,"Outcome measures will include healthcare utilization metrics (hospitalization rates, emergency room visit rates, and days to readmission), caregiver burden and caregiver satisfaction with home healthcare, HHN retention, and HHN collaboration with other healthcare providers.","[{'ForeName': 'Savithri', 'Initials': 'S', 'LastName': 'Nageswaran', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Easterling', 'Affiliation': 'Department of Social Sciences & Health Policy, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Cobi W', 'Initials': 'CW', 'LastName': 'Ingram Lcsw', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Skaar', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Miller-Fitzwater', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Ip', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100652']
2582,32964203,Uric Acid Lowering and Biomarkers of Kidney Damage in CKD Stage 3: A Post Hoc Analysis of a Randomized Clinical Trial.,"Rationale & Objective


Hyperuricemia is associated with chronic kidney disease (CKD) progression. We evaluated whether lowering serum uric acid levels improves levels of biomarkers of kidney damage.
Study Design


Post hoc analysis of clinical trial participants.
Setting & Participants


A double-blind randomized placebo-controlled study designed to lower serum uric acid levels. 80 patients with stage 3 CKD and asymptomatic hyperuricemia were randomly assigned to allopurinol treatment or placebo (300 mg/d) for 12 weeks.
Exposure/Predictor


Allopurinol treatment versus placebo.
Outcomes & Measures


We evaluated the change from baseline for the following urinary biomarkers of kidney damage: albumin-creatinine ratio (ACR), neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule 1 (KIM-1), and transforming growth factor β1 (TGF-β1). Additionally, we evaluated CKD Epidemiology Collaboration (CKD-EPI)-estimated glomerular filtration rate (eGFR) and cystatin C eGFR.
Analytical Approach


Generalized linear mixed modeling was used.
Results


After 12 weeks, allopurinol (compared to placebo) significantly lowered serum uric acid levels with an estimate of -3.3 mg/dL (95% CI, -4.1 to -2.5 mg/dL;  P  < 0.001). Estimates for the change for allopurinol versus placebo over time were 1.09 (95% CI, 0.77-1.54) for ACR, 0.77 (95% CI, 0.36-1.63) for NGAL, and 2.36 (95% CI, 0.97-5.70) for TGF-β1. The model did not converge for KIM-1, but Wilcoxon signed rank test showed no significant difference in change from baseline between study groups. There was no significant change observed in CKD-EPI eGFR or cystatin C eGFR.
Limitations


Post hoc analysis and short duration of the study.
Conclusions


Uric acid-lowering with allopurinol is not associated with improvement in levels of biomarkers of kidney damage in patients with asymptomatic hyperuricemia and stage 3 CKD.
Funding


The study was funded by the National Institutes of Health through a career development award, K23DK088833, and the Clinical and Translational Science Award UL1TR002537.
Trial Registration


NCT01228903.",2020,"The model did not converge for KIM-1, but Wilcoxon signed rank test showed no significant difference in change from baseline between study groups.","['in\xa0CKD Stage 3', '80 patients with stage 3 CKD and asymptomatic hyperuricemia', 'patients with asymptomatic hyperuricemia and stage 3 CKD']","['allopurinol treatment or placebo', 'dL', 'Allopurinol', 'placebo', 'allopurinol']","['serum uric acid levels', 'CKD Epidemiology Collaboration (CKD-EPI)-estimated glomerular filtration rate (eGFR) and cystatin C eGFR', 'CKD-EPI eGFR or cystatin C eGFR', 'kidney damage: albumin-creatinine ratio (ACR), neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule 1 (KIM-1), and transforming growth factor β1 (TGF-β1', 'Uric Acid Lowering and Biomarkers of Kidney Damage']","[{'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348944', 'cui_str': 'Hyperuricemia without signs of inflammatory arthritis and tophaceous disease'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",80.0,0.502869,"The model did not converge for KIM-1, but Wilcoxon signed rank test showed no significant difference in change from baseline between study groups.","[{'ForeName': 'Loni', 'Initials': 'L', 'LastName': 'Perrenoud', 'Affiliation': 'Division of Renal Diseases and Hypertension, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Kruse', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Carver College of Medicine, Iowa City, IA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Andrews', 'Affiliation': 'Division of Renal Diseases and Hypertension, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': 'Division of Renal Diseases and Hypertension, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Chaorong', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Institute for Clinical and Translational Science, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ten Eyck', 'Affiliation': 'Institute for Clinical and Translational Science, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Zepeda-Orozco', 'Affiliation': 'Division of Pediatric Nephrology, Dialysis and Transplantation, Stead Family Department of Pediatrics, University of Iowa, Iowa City, IA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Jalal', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Carver College of Medicine, Iowa City, IA.'}]",Kidney medicine,['10.1016/j.xkme.2019.11.007']
2583,32964215,Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies.,"BACKGROUND


Ustekinumab is currently approved globally in Crohn's disease (CD) and psoriatic diseases. Recent phase 3 data demonstrate safety/efficacy in ulcerative colitis (UC). Crohn's disease and UC phase 3 programs had similar study designs, facilitating integrated safety analyses.
METHODS


Data from 6 ustekinumab phase 2/3 CD and UC studies were pooled, and safety was evaluated through 1 year. Patients received 1 placebo or ustekinumab (generally 130 mg or ~6 mg/kg) intravenous induction, then subcutaneous (90 mg) maintenance every 8/12 weeks. Analyses incorporated all patients who received ≥1 ustekinumab dose. Safety outcomes are presented as percentages of patients (induction) and as number of patients with events per 100 patient-years of follow-up (through 1 year). For key safety events, 95% confidence intervals (CIs) are provided, as appropriate. Hazard ratios with 95% CIs from time-to-event analyses for serious adverse events and serious infections were also performed.
RESULTS


Through 1 year, 2574 patients received ustekinumab (1733 patient-years of follow-up). The number of patients with adverse events per 100 patient-years (placebo 165.99 [95% CI, 155.81-176.67] vs ustekinumab 118.32 [95% CI, 113.25-123.55]), serious AEs (27.50 [95% CI, 23.45-32.04] vs 21.23 [95% CI, 19.12-23.51]), infections (80.31 [95% CI, 73.28-87.84] vs 64.32 [95% CI, 60.60-68.21]), serious infections (5.53 [95% CI, 3.81-7.77] vs 5.02 [95% CI, 4.02-6.19]), and malignancies excluding nonmelanoma skin cancer (0.17 [95% CI, 0.00-0.93] vs 0.40 [95% CI, 0.16-0.83]) were similar between placebo and ustekinumab.
CONCLUSIONS


The safety profile of ustekinumab across the pooled inflammatory bowel disease population through 1 year was favorable and generally comparable to placebo. These data are consistent with the established safety profile of ustekinumab across indications.
CLINICALTRIALS.GOV NUMBERS


NCT00265122; NCT00771667; NCT01369329; NCT01369342; NCT01369355; NCT02407236.",2020,The safety profile of ustekinumab across the pooled inflammatory bowel disease population through 1 year was favorable and generally comparable to placebo.,"['2574 patients received', ""Crohn's disease (CD) and psoriatic diseases"", 'Inflammatory Bowel Disease', 'Data from 6 ustekinumab phase 2/3 CD and UC studies']","['placebo or ustekinumab', 'ustekinumab', 'placebo', 'Ustekinumab']","['infections', 'serious infections', 'malignancies excluding nonmelanoma skin cancer', 'Hazard ratios', 'number of patients with adverse events', 'serious AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0699893', 'cui_str': 'Skin carcinoma'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.580852,The safety profile of ustekinumab across the pooled inflammatory bowel disease population through 1 year was favorable and generally comparable to placebo.,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials, Robarts Research Institute, Western University, London, Ontario, Canada.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Humanitas Clinical Research Center-IRCCS and Humanitas University, Department of Biomedical Sciences, Milan, Italy.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': ""O'Brien"", 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Elyssa', 'Initials': 'E', 'LastName': 'Ott', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Baker', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Yiying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Volger', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Tikhonov', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gasink', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Subrata', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Institute of Translational Medicine and NIHR Biomedical Research Center, University of Birmingham, United Kingdom.'}]",Inflammatory bowel diseases,['10.1093/ibd/izaa236']
2584,32964282,Midface Lift Plus Lipofilling Preferential in Patients with Negative Lower Eyelid Vectors: A Randomized Controlled Trial.,"INTRODUCTION


In conducting this study, it was our presumption that lipofilling is a necessary and simultaneous adjunct to lifting the middle third of the face in patients with negative lower eyelid vectors, enabling satisfactory and enduring aesthetic results.
MATERIALS AND METHODS


Eligible patients met the following criteria: (1) primary midface lift in subperiosteal plane; (2) negative inferior eyelid vectors at preoperative baseline; (3) postoperative monitoring for ~ 2 years; (4) standard pre- and postoperative photo-documentation; (5) proficiency in Italian language; and (6) signed consent for study participation. Informed consent pertaining to photography allowed for subsequent publication. Pertinent patient data were also collected as follows: age, sex, duration of follow-up, type of surgical procedure, related secondary procedures, quantity of fat injected, nature of incision, and patient satisfaction level. Complete randomness was thus conferred during computer-assisted patient assignment to one of two study arms: midface lift only (group 1) or midface lift plus facial lipofilling as a concurrent operation (group 2). All patients completed Italian versions of the FACE-Q module, which were issued by e-mail approximately 2 years postoperatively. Two plastic surgeons reviewed all postoperative photographs of treated patients and rated outcomes on a scale of 1-5. Statistical analysis was powered by standard software expressing categorical data as numbers and percentages and quantitative data as means ± standard deviations.
RESULTS


Between January 2016 and March 2018, a total of 56 patients (women 48; men 8) subjected to primary midface lifts in subperiosteal plane at our Plastic Surgery Department met all criteria for study enrollment. Mean patient age was 56.5 years (range 40-70 years), and the mean follow-up period was 2.1 years (range 2-5 years). Differences in postoperative FACE-Q scoring by the two groups were significant (p < 0.01) across all domains. Outcomes in patients of group 2 remained stable during long-term follow-up, whereas significantly more secondary procedures were pursued by patients of group 1 (p < 0.01). Compared with group 1, the two reviewers encountered significantly greater satisfaction with surgical outcomes among patients of group 2 (p < 0.01).
CONCLUSIONS


In FACE-Q scoring, those undergoing lift-and-fill procedures reported the highest satisfaction levels.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,Differences in postoperative FACE-Q scoring by the two groups were significant (p < 0.01) across all domains.,"['Eligible patients met the following criteria: (1', 'Between January 2016 and March 2018, a total of 56 patients (women 48; men 8) subjected to primary midface lifts in subperiosteal plane at our Plastic Surgery Department met all criteria for study enrollment', 'Mean patient age was 56.5\xa0years (range 40-70\xa0years), and the mean follow-up period was 2.1\xa0years (range 2-5\xa0years', 'Patients with Negative Lower Eyelid Vectors']","['primary midface lift in subperiosteal plane; (2) negative inferior eyelid vectors at preoperative baseline; (3) postoperative monitoring for\u2009~\u20092\xa0years; (4) standard pre- and postoperative photo-documentation; (5) proficiency in Italian language', 'midface lift plus facial lipofilling as a concurrent operation']","['satisfaction with surgical outcomes', 'postoperative FACE-Q scoring']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0587528', 'cui_str': 'Plastic surgery department'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589109', 'cui_str': 'Postoperative monitoring'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]",56.0,0.0478922,Differences in postoperative FACE-Q scoring by the two groups were significant (p < 0.01) across all domains.,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Barone', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy. maurosabbarone@gmail.com.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Cogliandro', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Salzillo', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ciarrocchi', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Abu Hanna', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Russo', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Tenna', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Persichetti', 'Affiliation': 'Plastic and Reconstructive Surgery Unit, Campus Bio-Medico University of Rome, Via Alvaro Del Portillo 200, Rome, Italy.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01971-0']
2585,32964433,Author response to: Comment on: Effect of an individualized versus standard pneumoperitoneum pressure strategy on postoperative recovery: a randomized clinical trial in laparoscopic colorectal surgery.,,2020,,[],"['individualized versus standard pneumoperitoneum pressure strategy', 'laparoscopic colorectal surgery']",['postoperative recovery'],[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",,0.0743765,,"[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Diaz-Cambronero', 'Affiliation': 'Hospital Universitari i Politecnic La Fe, Anesthesiology.'}]",The British journal of surgery,['10.1002/bjs.11932']
2586,32964458,The effects of an educational programme about preeclampsia on women's awareness: a randomised control trial.,"AIM


To examine the effects of an interventional programme about preeclampsia on high-risk preeclampsia Jordanian women's awareness and pregnancy outcomes.
BACKGROUND


Preeclampsia is a leading cause of maternal death and illness globally, and has a high rate in Jordan compared to other countries. Increasing preeclampsia awareness is recommended to prevent its serious complications.
METHODS


A randomized controlled trial was conducted at a public hospital in Jordan. A consecutive sample of 113 pregnant high-risk preeclampsia women was recruited and divided randomly into interventional and control groups. A questionnaire comprising seven terms on demographics and 51 questions assessing women's awareness on preeclampsia was used. The intervention group received a 2-h educational programme about preeclampsia with self-monitoring of blood pressure and urine protein and routine care, while the control group received a 2-h educational programme relevant to urinary tract infection and received routine care. A pretest was carried out at baseline and 2 weeks after the intervention, a post-test was performed for the two groups.
RESULTS


The results revealed a significant difference in mean scores for awareness of preeclampsia in the interventional group compared to the control group after conducting the education programme. A significant difference was also found between both groups in terms of Apgar scores at 1st min and 5th min and mean diastolic BP. CONCLUSION AND IMPLICATIONS FOR NURSING, HEALTH AND EDUCATION POLICY: Preeclampsia educational programme is effective in improving preeclampsia awareness and some pregnancy outcomes. Midwifery and nursing educators are highly encouraged to train midwives and nurses to be effective health professionals. Health educational programmes need to be designed by professionals based on an updated evidence and women's needs. It is of importance that these programmes focus on involving women in their health care by self-monitoring and providing women with the necessary resources to improve pregnancy outcomes.",2020,A significant difference was also found between both groups in terms of Apgar scores at 1st min and 5th min and mean diastolic BP.,"['public hospital in Jordan', '113 pregnant high-risk preeclampsia women', ""women's awareness""]","['interventional programme about preeclampsia', 'Preeclampsia educational programme', 'educational programme about preeclampsia', '2-h educational programme about preeclampsia with self-monitoring of blood pressure and urine protein and routine care, while the control group received a 2-h educational programme relevant to urinary tract infection and received routine care']","['Apgar scores', 'mean diastolic BP', 'mean scores for awareness of preeclampsia', 'preeclampsia awareness']","[{'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]","[{'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]",113.0,0.0591804,A significant difference was also found between both groups in terms of Apgar scores at 1st min and 5th min and mean diastolic BP.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Alnuaimi', 'Affiliation': 'Maternal and Child Health Nursing Department, Faculty of Nursing, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Abuidhail', 'Affiliation': 'Department of Maternal, Child and Family Health Nursing, Faculty of Nursing, Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Abuzaid', 'Affiliation': 'Jordan University of Science and Technology, Irbid, Jordan.'}]",International nursing review,['10.1111/inr.12626']
2587,32964468,Feasibility and early effectiveness of the Tell-us Card communication tool to increase in-hospital patient participation: a cluster randomised controlled pilot study.,"BACKGROUND


Patient participation is fundamental to nursing care and has beneficial effects on patient outcomes. However, it is not well embedded yet and little is known on how nurses could effectively stimulate patient participation in hospital care. The Tell-us Card is a communication tool for inviting patients to talk about their preferences and needs, and to increase patient participation in daily care.
OBJECTIVES


To assess feasibility and early effectiveness of the Tell-us Card communication tool for enhanced patient participation during hospitalisation.
DESIGN AND METHOD


A pilot cluster randomised controlled study design was used including four nursing wards. Effectiveness was measured with the Individualized Care Scale (ICS) and the Quality from the Patients' Perspective (QPP) questionnaire. Linear mixed model analysis was used for analysis. Feasibility was assessed with an evaluative questionnaire for patients and nurses and by reviewing the content of Tell-us Cards using the Fundamentals of Care Framework (FOCF) for analysis. Ethical approval was attained.
RESULTS


Data of 265 patients showed a significant increase at one intervention ward on the ICS (effect size 0.61, p = 0.02) and most ICS subscales. No effect was visible on the QPP. The majority of patients regarded the intervention as beneficial; nurses however experienced barriers with incorporating the Tell-us Card into daily care. Analysis of the Tell-us Card content showed many elements of the FOCF being mentioned, with most patients indicating psychosocial needs like being involved and informed.
CONCLUSIONS


This pilot study showed a positive early effect of the Tell-us Card communication tool on patient participation, although integration in daily nursing care appeared to be complex and an optimal fit has not yet been reached. Patients were positive about the intervention and wrote meaningful issues on the Tell-us Cards. More research is needed on how to incorporate patient participation effectively in complex hospital care.",2020,"RESULTS


Data of 265 patients showed a significant increase at one intervention ward on the ICS (effect size 0.61, p = 0.02) and most ICS subscales.","['hospital patient participation', 'four nursing wards']",['Tell-us Card communication tool'],"[""Individualized Care Scale (ICS) and the Quality from the Patients' Perspective (QPP) questionnaire""]","[{'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0279501,"RESULTS


Data of 265 patients showed a significant increase at one intervention ward on the ICS (effect size 0.61, p = 0.02) and most ICS subscales.","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van Belle', 'Affiliation': 'Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Getty', 'Initials': 'G', 'LastName': 'Huisman-De Waal', 'Affiliation': 'Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'Vermeulen', 'Affiliation': 'Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Heinen', 'Affiliation': 'Radboud Institute for Health Sciences, IQ Healthcare, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Scandinavian journal of caring sciences,['10.1111/scs.12909']
2588,32960889,Bifidobacterium animalis subsp lactis HN019 presents antimicrobial potential against periodontopathogens and modulates the immunological response of oral mucosa in periodontitis patients.,"OBJECTIVE


To evaluate the effects of Bifidobacterium animalis subsp. lactis HN019 (HN019) on clinical periodontal parameters (plaque accumulation and gingival bleeding), on immunocompetence of gingival tissues [expression of beta-defensin (BD)-3, toll-like receptor 4 (TLR4), cluster of differentiation(CD)-57 and CD-4], and on immunological properties of saliva (IgA levels) in non-surgical periodontal therapy in generalized chronic periodontitis (GCP) patients. Adhesion to buccal epithelial cells (BEC) and the antimicrobial properties of HN019 were also investigated.
MATERIALS AND METHODS


Thirty patients were recruited and monitored clinically at baseline (before scaling and root planing-SRP) and after 30 and 90 days. Patients were randomly assigned to Test (SRP+Probiotic, n = 15) or Control (SRP+Placebo, n = 15) group. Probiotic lozenges were used for 30 days. Gingival tissues and saliva were immunologically analyzed. The adhesion of HN019 with or without Porphyromonas gingivalis in BEC and its antimicrobial properties were investigated in in vitro assays. Data were statistically analyzed (p<0.05).
RESULTS


Test group presented lower plaque index (30 days) and lower marginal gingival bleeding (90 days) when compared with Control group. Higher BD-3, TLR4 and CD-4 expressions were observed in gingival tissues in Test group than in Control group. HN019 reduced the adhesion of P. gingivalis to BEC and showed antimicrobial potential against periodontopathogens.
CONCLUSION


Immunological and antimicrobial properties of B. lactis HN019 make it a potential probiotic to be used in non-surgical periodontal therapy of patients with GCP.
CLINICAL RELEVANCE


B. lactis HN019 may be a potential probiotic to improve the effects of non-surgical periodontal therapy. Name of the registry and registration number (ClinicalTrials.gov): ""Effects of probiotic therapy in the treatment of periodontitis""-NCT03408548.",2020,"Higher BD-3, TLR4 and CD-4 expressions were observed in gingival tissues in Test group than in Control group.","['generalized chronic periodontitis (GCP) patients', 'periodontitis patients', 'patients with GCP', 'Thirty patients were recruited and monitored clinically at baseline (before scaling and root planing-SRP) and after 30 and 90 days']","['Bifidobacterium animalis subsp', 'probiotic therapy', 'Control (SRP+Placebo', 'Probiotic lozenges']","['marginal gingival bleeding', 'Higher BD-3, TLR4 and CD-4 expressions', 'clinical periodontal parameters (plaque accumulation and gingival bleeding), on immunocompetence of gingival tissues [expression of beta-defensin (BD)-3, toll-like receptor 4 (TLR4), cluster of differentiation(CD)-57 and CD-4], and on immunological properties of saliva (IgA levels', 'lower plaque index', 'adhesion of P. gingivalis to BEC', 'Gingival tissues and saliva']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0074512', 'cui_str': 'SRP (Signal Recognition Particle)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C2242626', 'cui_str': 'Probiotic therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0887942', 'cui_str': 'beta-Defensins'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0020987', 'cui_str': 'Immunologic competence'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0014597', 'cui_str': 'Epithelial cell'}]",30.0,0.0273598,"Higher BD-3, TLR4 and CD-4 expressions were observed in gingival tissues in Test group than in Control group.","[{'ForeName': 'Marcos M', 'Initials': 'MM', 'LastName': 'Invernici', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Flávia A C', 'Initials': 'FAC', 'LastName': 'Furlaneto', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Sérgio L', 'Initials': 'SL', 'LastName': 'Salvador', 'Affiliation': 'Department of Clinical Analyses, School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Arthur C', 'Initials': 'AC', 'LastName': 'Ouwehand', 'Affiliation': 'Dupont, Nutrition and Health, Kantvik, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Salminen', 'Affiliation': 'Functional Foods Forum, University of Turku, Turku, Finland.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Mantziari', 'Affiliation': 'Functional Foods Forum, University of Turku, Turku, Finland.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Vinderola', 'Affiliation': 'Instituto de Lactología Industrial (UNL-CONICET), National University of the Litoral, Santa Fe, Argentina.'}, {'ForeName': 'Edilson', 'Initials': 'E', 'LastName': 'Ervolino', 'Affiliation': 'Division of Histology, Department of Basic Sciences, Dental School of Araçatuba, São Paulo State University, São Paulo, Brazil.'}, {'ForeName': 'Sandro Isaías', 'Initials': 'SI', 'LastName': 'Santana', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Pedro Henrique Felix', 'Initials': 'PHF', 'LastName': 'Silva', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Michel R', 'Initials': 'MR', 'LastName': 'Messora', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil.'}]",PloS one,['10.1371/journal.pone.0238425']
2589,32960920,"Effects of passive, active, and mixed playing strategies on external and internal loads in female tennis players.","This study aimed to investigate the effects of different playing strategies on external and internal loads in female tennis players during match play. Also, the underlying effects on the technical-tactical actions and activity profiles were examined. Twelve well-trained female players (age: 25±5 years; maximum oxygen uptake: 40.9±4.3 ml/kg/min) played points against an opponent of similar ability outdoors on red-clay courts. The players played points over five playing conditions. Before each condition, the players were instructed to apply either a passive, an active, or their own playing strategy (free play) to succeed. The five conditions were played in a randomized order, whereas the condition with the own strategy was always played first and served as control. During play, the external and internal loads were investigated by 10 Hz global positioning system, 100 Hz inertial measurement unit, short-range telemetry, capillary blood, and visual analog scale procedures. A 25 Hz video camera was used to examine the technical-tactical actions and activity profiles. Compared to the control condition, the passive, active, and mixed playing strategy conditions induce up to large effects on the external loads (running distances with high acceleration and deceleration), up to moderate effects on the internal loads (energy expenditures spent with high metabolic power, lactate concentration, and rating of effort), and up to very large effects on the technical-tactical actions (number of ground strokes and errors) and activity profiles (strokes per rally, rally duration, work to rest ratio, and effective playing time). Our study shows that passive, active, and mixed playing strategies have an impact on the external and internal loads, technical-tactical actions, and activity profiles of female tennis players during match play. This finding should be considered for practical purposes like match analyses and training procedures in the tennis environment.",2020,"Compared to the control condition, the passive, active, and mixed playing strategy conditions induce up to large effects on the external loads (running distances with high acceleration and deceleration), up to moderate effects on the internal loads (energy expenditures spent with high metabolic power, lactate concentration, and rating of effort), and up to very large effects on the technical-tactical actions (number of ground strokes and errors) and activity profiles (strokes per rally, rally duration, work to rest ratio, and effective playing time).","['female tennis players', 'Twelve well-trained female players (age: 25±5 years; maximum oxygen uptake: 40.9±4.3 ml/kg/min) played points against an opponent of similar ability outdoors on red-clay courts', 'female tennis players during match play']","['passive, active, and mixed playing strategies']","['technical-tactical actions (number of ground strokes and errors) and activity profiles (strokes per rally, rally duration, work to rest ratio, and effective playing time', 'technical-tactical actions and activity profiles']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0174105,"Compared to the control condition, the passive, active, and mixed playing strategy conditions induce up to large effects on the external loads (running distances with high acceleration and deceleration), up to moderate effects on the internal loads (energy expenditures spent with high metabolic power, lactate concentration, and rating of effort), and up to very large effects on the technical-tactical actions (number of ground strokes and errors) and activity profiles (strokes per rally, rally duration, work to rest ratio, and effective playing time).","[{'ForeName': 'Matthias W', 'Initials': 'MW', 'LastName': 'Hoppe', 'Affiliation': 'Institute of Movement and Training Science I, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hotfiel', 'Affiliation': 'Center for Musculoskeletal Surgery Osnabrück (OZMC), Klinikum Osnabrück, Osnabrück, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Stückradt', 'Affiliation': 'Department of Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Grim', 'Affiliation': 'Center for Musculoskeletal Surgery Osnabrück (OZMC), Klinikum Osnabrück, Osnabrück, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Ueberschär', 'Affiliation': 'Institute for Applied Training Science (IAT), Leipzig, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Freiwald', 'Affiliation': 'Department of Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baumgart', 'Affiliation': 'Department of Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}]",PloS one,['10.1371/journal.pone.0239463']
2590,32960954,Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery.,"BACKGROUND


The Hypotension Prediction Index is a commercially available algorithm, based on arterial waveform features, that predicts hypotension defined as mean arterial pressure less than 65 mmHg for at least 1 min. We therefore tested the primary hypothesis that index guidance reduces the duration and severity of hypotension during noncardiac surgery.
METHODS


We enrolled adults having moderate- or high-risk noncardiac surgery with invasive arterial pressure monitoring. Participating patients were randomized to hemodynamic management with or without index guidance. Clinicians caring for patients assigned to guidance were alerted when the index exceeded 85 (range, 0 to 100) and a treatment algorithm based on advanced hemodynamic parameters suggested vasopressor administration, fluid administration, inotrope administration, or observation. Primary outcome was the amount of hypotension, defined as time-weighted average mean arterial pressure less than 65 mmHg. Secondary outcomes were time-weighted mean pressures less than 60 and 55 mmHg.
RESULTS


Among 214 enrolled patients, guidance was provided for 105 (49%) patients randomly assigned to the index guidance group. The median (first quartile, third quartile) time-weighted average mean arterial pressure less than 65 mmHg was 0.14 (0.03, 0.37) in guided patients versus 0.14 (0.03, 0.39) mmHg in unguided patients: median difference (95% CI) of 0 (-0.03 to 0.04), P = 0.757. Index guidance therefore did not reduce amount of hypotension less than 65 mmHg, nor did it reduce hypotension less than 60 or 55 mmHg. Post hoc, guidance was associated with less hypotension when analysis was restricted to episodes during which clinicians intervened.
CONCLUSIONS


In this pilot trial, index guidance did not reduce the amount of intraoperative hypotension. Half of the alerts were not followed by treatment, presumably due to short warning time, complex treatment algorithm, or clinicians ignoring the alert. In the future we plan to use a lower index alert threshold and a simpler treatment algorithm that emphasizes prompt treatment.
EDITOR’S PERSPECTIVE


",2020,"Index guidance therefore did not reduce amount of hypotension less than 65 mmHg, nor did it reduce hypotension less than 60 or 55 mmHg.","['214 enrolled patients, guidance was provided for 105 (49', 'enrolled adults having moderate- or high-risk noncardiac surgery with invasive arterial pressure monitoring']",['hemodynamic management with or without index guidance'],"['hypotension', 'amount of hypotension, defined as time-weighted average mean arterial pressure less', 'hypotension less', 'duration and severity of hypotension', 'intraoperative hypotension', 'time-weighted mean pressures less']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0428890', 'cui_str': 'Invasive arterial pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C0445074', 'cui_str': 'Mean pressure'}]",214.0,0.0978421,"Index guidance therefore did not reduce amount of hypotension less than 65 mmHg, nor did it reduce hypotension less than 60 or 55 mmHg.","[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': ''}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Shimada', 'Affiliation': ''}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Khanna', 'Affiliation': ''}, {'ForeName': 'Jacek B', 'Initials': 'JB', 'LastName': 'Cywinski', 'Affiliation': ''}, {'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Irefin', 'Affiliation': ''}, {'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': ''}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': ''}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': ''}, {'ForeName': 'Yuwei', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Saha', 'Affiliation': ''}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': ''}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003557']
2591,32961041,Improving rehabilitation in sarcopenia: a randomized-controlled trial utilizing a muscle-targeted food for special medical purposes.,"BACKGROUND


Sarcopenia is a disease associated with aging and a negative prognosis. Consensus-based treatment consists in targeting muscle mass and function through physical exercise, optimization of protein intake, and vitamin D supplementation, but evidence is lacking. We evaluated the safety and efficacy of a muscle-targeted nutritional support on the outcome of a physical exercise rehabilitation programme.
METHODS


In a single-site, double-blind, randomized, controlled trial (NCT03120026; May 2017 to December 2018), old (≥65 years) adults [N = 140 (63% female patients; age, 81 ± 6 years)] without severe cognitive impairment, who were found to have sarcopenia by European Working Group on Sarcopenia in Older People 2010 criteria and hospitalized for physical rehabilitation, were randomized to receive until discharge (for at least 4 weeks and up to 8 weeks) a whey protein-based nutritional formula enriched with leucine and vitamin D or an iso-caloric control formula twice daily in addition to a standard hospital diet. The primary endpoint was the change in 4 m gait speed per month. Key secondary endpoints addressed the change in physical performance: chair-stand test, timed up and go test, and short physical performance battery. Other secondary outcomes were the change in functional status, muscle strength and mass, cognitive status, and quality of life. The proportion of patients who improved their rehabilitation intensity profile and overall economic benefits (using length of stay and duration of rehabilitation as surrogate measures) were also evaluated.
RESULTS


A total of 161 patients were screened and 140 were randomized to study interventions. Thirteen patients (experimental, n = 6; placebo, n = 7) discontinued the intervention because they disliked the product and intention-to-treat analyses were based on patients reassessed at discharge [n = 127 (66% female patients; age, 81 ± 6 years)]. Supplementation with the experimental formula (n = 64) resulted in greater increase in mean gait speed {0.061 m/s/month [95% confidence interval (CI), 0.043 to 0.080]} than placebo [n = 63; -0.001 m/s/month (95%CI, -0.008 to 0.006)]: mean difference, 0.063 m/s/month (95%CI, 0.043 to 0.082) (P < 0.001). A significant effect was also found for muscle mass (P < 0.03) and all key secondary outcomes, functional and cognitive endpoints (P < 0.001 for all). Supplementation resulted also in higher proportion of patients improving their rehabilitation intensity profile (P = 0.003) and being discharged home (P = 0.002); shorter rehabilitation (P < 0.001); and hospital stay (P < 0.001).
CONCLUSIONS


In old adults with sarcopenia admitted to hospital for rehabilitation the consumption of a whey protein-based nutritional formula enriched with leucine and vitamin D improved physical performance and function, as well as muscle mass, and reduced the intensity and costs of care.",2020,"Supplementation with the experimental formula (n = 64) resulted in greater increase in mean gait speed {0.061 m/s/month [95% confidence interval (CI), 0.043 to 0.080]} than placebo [n = 63; -0.001 m/s/month (95%CI, -0.008 to 0.006)]: mean difference, 0.063 m/s/month (95%CI, 0.043 to 0.082) (P < 0.001).","['sarcopenia', 'Thirteen patients (experimental, n = 6; placebo, n = 7) discontinued the intervention because they disliked the product and intention-to-treat analyses were based on patients reassessed at discharge [n = 127 (66% female patients; age, 81 ± 6 years', 'A total of 161 patients were screened and 140', 'old adults with sarcopenia admitted to hospital for rehabilitation the consumption of a whey protein-based nutritional formula enriched with', '2017 to December 2018), old (≥65 years) adults [N = 140 (63% female patients; age, 81 ± 6 years)] without severe cognitive impairment, who were found to have sarcopenia by European Working Group on Sarcopenia in Older People 2010 criteria and hospitalized for physical rehabilitation']","['leucine and vitamin D', 'whey protein-based nutritional formula enriched with leucine and vitamin D or an iso-caloric control formula twice daily in addition to a standard hospital diet', 'placebo', 'muscle-targeted nutritional support']","['change in 4 m gait speed per month', 'change in functional status, muscle strength and mass, cognitive status, and quality of life', 'functional and cognitive endpoints', 'muscle mass', 'hospital stay', 'safety and efficacy', 'change in physical performance: chair-stand test, timed up and go test, and short physical performance battery', 'higher proportion of patients improving their rehabilitation intensity profile', 'mean gait speed ']","[{'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",161.0,0.144778,"Supplementation with the experimental formula (n = 64) resulted in greater increase in mean gait speed {0.061 m/s/month [95% confidence interval (CI), 0.043 to 0.080]} than placebo [n = 63; -0.001 m/s/month (95%CI, -0.008 to 0.006)]: mean difference, 0.063 m/s/month (95%CI, 0.043 to 0.082) (P < 0.001).","[{'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS, Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Cereda', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Klersy', 'Affiliation': 'Biometry and Clinical Epidemiology Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Milena Anna', 'Initials': 'MA', 'LastName': 'Faliva', 'Affiliation': 'Azienda di Servizi alla Persona (ASP) di Pavia, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Peroni', 'Affiliation': 'Azienda di Servizi alla Persona (ASP) di Pavia, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Nichetti', 'Affiliation': 'Azienda di Servizi alla Persona (ASP) di Pavia, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Gasparri', 'Affiliation': 'Azienda di Servizi alla Persona (ASP) di Pavia, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Iannello', 'Affiliation': 'Directorate General, Azienda di Servizi alla Persona (ASP) di Pavia, Pavia, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Spadaccini', 'Affiliation': 'Azienda di Servizi alla Persona (ASP) di Pavia, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Infantino', 'Affiliation': 'Azienda di Servizi alla Persona (ASP) di Pavia, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Caccialanza', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': 'Department of Biology, College of Science, University of Bahrain, Kingdom of Bahrain.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12532']
2592,32961065,Feasibility and Effects on the Gut Microbiota of a 12-Week High Intensity Interval Training plus Lifestyle Education Intervention on Inactive Adults with Celiac Disease.,"This study assessed the feasibility and benefits of high intensity interval training (HIIT) plus lifestyle education among inactive adults with celiac disease. 41 participants were randomized to receive the intervention (HIIT+) for 12-weeks or waitlist control (WLC). Testing was completed at baseline, immediately post- and 3-months post-intervention. Generalized estimating equations were used to assess changes in the outcome variables over time between the groups. Mean percent of age-predicted maximum heart rate was 97.9% and average rating of perceived exertion (RPE) was 6.33 (out of 10) during HIIT intervals. Following the intervention, the HIIT+ group showed enrichment in relative abundance of Parabacteroides and Defluviitaleaceae_UCG¬_011 while WLC showed enrichment in relative abundance of Roseburia intestinalis, Klebsiella and Adlercreutzia. A unique set of taxa were differentially abundant between the groups at 3-months post-intervention. HIIT+ participants experienced a reduction in resting heart rate (-6.6 bpm) immediately post-intervention compared to WLC. Further research is needed to establish an optimal HIIT protocol that may improve VO2max and metabolic syndrome biomarkers. Findings from this pilot study provide preliminary evidence that a HIIT+ intervention is feasible for inactive adults with celiac disease and leads to favourable changes in resting HR alongside potentially beneficial shifts in gut microbiota. Trial registration number: ClinicalTrials.gov number NCT03520244 Novelty • High intensity interval training leads to potentially beneficial changes in the gut microbiota of adults with celiac disease. • A high intensity interval training exercise intervention is feasible and well tolerated for patients with celiac disease.",2020,Findings from this pilot study provide preliminary evidence that a HIIT+ intervention is feasible for inactive adults with celiac disease and leads to favourable changes in resting HR alongside potentially beneficial shifts in gut microbiota.,"['inactive adults with celiac disease', 'adults with celiac disease', 'Inactive Adults with Celiac Disease', '41 participants', 'patients with celiac disease']","['HIIT+ intervention', '12-Week High Intensity Interval Training plus Lifestyle Education Intervention', 'high intensity interval training (HIIT) plus lifestyle education', 'intensity interval training exercise intervention', 'High intensity interval training', 'intervention (HIIT+) for 12-weeks or waitlist control (WLC']","['relative abundance of Roseburia intestinalis, Klebsiella and Adlercreutzia', 'resting heart rate', 'maximum heart rate']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1196244', 'cui_str': 'Roseburia intestinalis'}, {'cui': 'C0022727', 'cui_str': 'Klebsiella'}, {'cui': 'C2280992', 'cui_str': 'Adlercreutzia'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}]",41.0,0.0533807,Findings from this pilot study provide preliminary evidence that a HIIT+ intervention is feasible for inactive adults with celiac disease and leads to favourable changes in resting HR alongside potentially beneficial shifts in gut microbiota.,"[{'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Warbeck', 'Affiliation': 'University of Calgary, 2129, Calgary, Alberta, Canada , T2N 1N4 ; cbwarbec@ucalgary.ca.'}, {'ForeName': 'A Justine', 'Initials': 'AJ', 'LastName': 'Dowd', 'Affiliation': 'University of Calgary, 2129, Faculty of Kinesiology, Calgary, Alberta, Canada ; jdowd@ucalgary.ca.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Kronlund', 'Affiliation': 'University of Calgary, 2129, Calgary, Alberta, Canada ; ljkronlu@ucalgary.ca.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Parmar', 'Affiliation': 'University of Calgary, 2129, Calgary, Alberta, Canada ; parmarc@ucalgary.ca.'}, {'ForeName': 'Julia T', 'Initials': 'JT', 'LastName': 'Daun', 'Affiliation': 'University of Calgary, 2129, Calgary, Alberta, Canada ; jtdaun@ucalgary.ca.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Wytsma-Fisher', 'Affiliation': 'University of Calgary, 2129, Calgary, Alberta, Canada ; kawytsma@ucalgary.ca.'}, {'ForeName': 'Guillaume Y', 'Initials': 'GY', 'LastName': 'Millet', 'Affiliation': 'University of Calgary , Kinesiology , 2500 University Drive NW , Calgary, Alberta, Canada , T2N 1N4 ; gmillet@ucalgary.ca.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Schick', 'Affiliation': 'University of Calgary, 2129, Calgary, Alberta, Canada ; a.schick@ucalgary.ca.'}, {'ForeName': 'Raylene A', 'Initials': 'RA', 'LastName': 'Reimer', 'Affiliation': 'University of Calgary , Faculties of Kinesiology and Medicine , Room 440 KNB , Calgary, Alberta, Canada , T2N 1N4 ; reimer@ucalgary.ca.'}, {'ForeName': 'Tak', 'Initials': 'T', 'LastName': 'Fung', 'Affiliation': 'Unversity of Calgary, Calgary, Alberta, Canada ; tfung@ucalgary.ca.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'University of Calgary , Department of Kinesiology , Calgary, Alberta, Canada ; nculosre@ucalgary.ca.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0459']
2593,32961119,"Adjuvant nivolumab versus ipilimumab in resected stage IIIB-C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial.","BACKGROUND


Previously, findings from CheckMate 238, a double-blind, phase 3 adjuvant trial in patients with resected stage IIIB-C or stage IV melanoma, showed significant improvements in recurrence-free survival and distant metastasis-free survival with nivolumab versus ipilimumab. This report provides updated 4-year efficacy, initial overall survival, and late-emergent safety results.
METHODS


This multicentre, double-blind, randomised, controlled, phase 3 trial was done in 130 academic centres, community hospitals, and cancer centres across 25 countries. Patients aged 15 years or older with resected stage IIIB-C or IV melanoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 were randomly assigned (1:1) to receive nivolumab or ipilimumab via an interactive voice response system and stratified according to disease stage and baseline PD-L1 status of tumour cells. Patients received intravenous nivolumab 3 mg/kg every 2 weeks or intravenous ipilimumab 10 mg/kg every 3 weeks for four doses, and then every 12 weeks until 1 year of treatment, disease recurrence, unacceptable toxicity, or withdrawal of consent. The primary endpoint was recurrence-free survival by investigator assessment, and overall survival was a key secondary endpoint. Efficacy analyses were done in the intention-to-treat population (all randomly assigned patients). All patients who received at least one dose of study treatment were included in the safety analysis. The results presented in this report reflect the 4-year update of the ongoing study with a database lock date of Jan 30, 2020. This study is registered with ClinicalTrials.gov, NCT02388906.
FINDINGS


Between March 30 and Nov 30, 2015, 906 patients were assigned to nivolumab (n=453) or ipilimumab (n=453). Median follow-up was 51·1 months (IQR 41·6-52·7) with nivolumab and 50·9 months (36·2-52·3) with ipilimumab; 4-year recurrence-free survival was 51·7% (95% CI 46·8-56·3) in the nivolumab group and 41·2% (36·4-45·9) in the ipilimumab group (hazard ratio [HR] 0·71 [95% CI 0·60-0·86]; p=0·0003). With 211 (100 [22%] of 453 patients in the nivolumab group and 111 [25%] of 453 patients in the ipilimumab group) of 302 anticipated deaths observed (about 73% of the originally planned 88% power needed for significance), 4-year overall survival was 77·9% (95% CI 73·7-81·5) with nivolumab and 76·6% (72·2-80·3) with ipilimumab (HR 0·87 [95% CI 0·66-1·14]; p=0·31). Late-emergent grade 3-4 treatment-related adverse events were reported in three (1%) of 452 and seven (2%) of 453 patients. The most common late-emergent treatment-related grade 3 or 4 adverse events reported were diarrhoea, diabetic ketoacidosis, and pneumonitis (one patient each) in the nivolumab group, and colitis (two patients) in the ipilimumab group. Two previously reported treatment-related deaths in the ipilimumab group were attributed to study drug toxicity (marrow aplasia in one patient and colitis in one patient); no further treatment-related deaths were reported.
INTERPRETATION


At a minimum of 4 years' follow-up, nivolumab demonstrated sustained recurrence-free survival benefit versus ipilimumab in resected stage IIIB-C or IV melanoma indicating a long-term treatment benefit with nivolumab. With fewer deaths than anticipated, overall survival was similar in both groups. Nivolumab remains an efficacious adjuvant treatment for patients with resected high-risk melanoma, with a safety profile that is more tolerable than that of ipilimumab.
FUNDING


Bristol Myers Squibb and Ono Pharmaceutical.",2020,"At a minimum of 4 years' follow-up, nivolumab demonstrated sustained recurrence-free survival benefit versus ipilimumab in resected stage IIIB-C or IV melanoma indicating a long-term treatment benefit with nivolumab.","['resected stage IIIB-C and stage IV melanoma (CheckMate 238', 'Patients aged 15 years or older with resected stage IIIB-C or IV melanoma and an Eastern Cooperative Oncology Group performance status of 0 or 1', '130 academic centres, community hospitals, and cancer centres across 25 countries', 'Between March 30 and Nov 30, 2015', '906 patients were assigned to nivolumab (n=453) or', 'patients with resected stage IIIB-C or stage IV melanoma', 'patients with resected high-risk melanoma']","['intravenous nivolumab 3 mg/kg every 2 weeks or intravenous ipilimumab', 'nivolumab or ipilimumab', 'ipilimumab', 'Adjuvant nivolumab versus ipilimumab', 'Nivolumab']","['sustained recurrence-free survival benefit', 'recurrence-free survival by investigator assessment, and overall survival', 'deaths', 'adverse events', 'drug toxicity (marrow aplasia', '4-year overall survival', 'recurrence-free survival', 'diarrhoea, diabetic ketoacidosis, and pneumonitis', 'overall survival', 'recurrence-free survival and distant metastasis-free survival']","[{'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013221', 'cui_str': 'Poisoning by drug AND/OR medicinal substance'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0000846', 'cui_str': 'Agenesis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",906.0,0.794635,"At a minimum of 4 years' follow-up, nivolumab demonstrated sustained recurrence-free survival benefit versus ipilimumab in resected stage IIIB-C or IV melanoma indicating a long-term treatment benefit with nivolumab.","[{'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy. Electronic address: paolo.ascierto@gmail.com.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Del Vecchio', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandalá', 'Affiliation': 'Papa Giovanni XIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Arance', 'Affiliation': 'Hospital Clínic de Barcelona-IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon, Pierre Bénite, France.'}, {'ForeName': 'C Lance', 'Initials': 'CL', 'LastName': 'Cowey', 'Affiliation': 'Texas Oncology-Baylor Charles A Sammons Cancer Center, Dallas, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenker', 'Affiliation': 'Oncology Center Sf Nectarie, Craiova, Romania.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Department of Dermatology, Aix-Marseille University, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Márquez-Rodas', 'Affiliation': 'Department of Medical Oncology, General University Hospital Gregorio Marañón and CIBERONC, Madrid, Spain.'}, {'ForeName': 'Marcus O', 'Initials': 'MO', 'LastName': 'Butler', 'Affiliation': 'Department of Immuno-oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'Department of Oncology, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'de la Cruz-Merino', 'Affiliation': 'Department of Clinical Oncology, Hospital University Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Arenberger', 'Affiliation': 'Department of Dermatology, Charles University Third Faculty of Medicine and University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Division of Cancer Services, Gallipoli Medical Research Foundation, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Medical Oncology, Tasman Health Care, Southport, QLD, Australia.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Fecher', 'Affiliation': 'Department of Medical Oncology, Internal Medicine, University of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Millward', 'Affiliation': 'Department of Internal Medicine, University of Western Australia and Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Nikhil I', 'Initials': 'NI', 'LastName': 'Khushalani', 'Affiliation': 'Department of Cutaneous Oncology, H Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Queirolo', 'Affiliation': 'IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Lobo', 'Affiliation': 'Oncology Clinical Development, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'de Pril', 'Affiliation': 'Department of Global Regulatory and Safety Sciences, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Loffredo', 'Affiliation': 'Clinical Biomarkers, Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Department of Medical Oncology, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30494-0']
2594,32961126,"Does a Nasal Airway Facilitate Nasotracheal Intubation or Not? A Prospective, Randomized, and Controlled Study.","PURPOSE


Nasotracheal intubation (NTI) is generally preferred for maxillofacial surgery to provide a more suitable and wide surgery area for the surgeons. The purpose of the study was to evaluate whether using a nasal airway just before the NTI may facilitate NTI or not.
METHODS


This prospective, randomized, and controlled study was performed on patients who were admitted to our hospital for maxillofacial surgery. In group 1, a nasal airway was used just before the NTI during mask ventilation, and patients in the group were ventilated without nasal airway. Airway group was the primary predictor of the study. The NTI duration was the primary outcome variable, and the number of attempts was the secondary outcome variable. Difficulty of ventilation and complications were the other variables that were recorded.
RESULTS


A total of 70 patients were included in the study and divided into 2 groups. There was no statistically significant relationship between the duration of NTI and other variables, but the significance value for sternomental distance, ventilation difficulty, and epistaxis was P < .10. The NTI duration (the primary outcome variable) and the number of attempts (the secondary outcome variable) are statistically lower in the nasal airway group (group 1) than the control group (group 2). Ventilation difficulty was significantly higher in group 2 when compared with group 1 (P = .04). The model and regression coefficients for both variables are statistically significant in terms of duration of NTI and number of attempt values that they were lower in nasal airway group than the control group. There were no statistically significant differences between the groups in terms of complications (P < .05).
CONCLUSIONS


The present study has shown that inserting a nasal airway into the nostril just before the NTI may facilitate the intubation process by preparing the nasal passage.",2020,"There were no statistically significant differences between the groups in terms of complications (P < .05).
","['patients who were admitted to our hospital for maxillofacial surgery', 'A total of 70 patients were included in the study and divided into 2 groups']","['Nasotracheal intubation (NTI', 'ventilated without nasal airway']","['Difficulty of ventilation and complications', 'duration of NTI and number of attempt values', 'number of attempts', 'Ventilation difficulty', 'sternomental distance, ventilation difficulty, and epistaxis', 'NTI duration', 'duration of NTI', 'complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0150683', 'cui_str': 'Nasopharyngeal airway device'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1959922', 'cui_str': 'Sternomental distance'}]",70.0,0.0355266,"There were no statistically significant differences between the groups in terms of complications (P < .05).
","[{'ForeName': 'Dilek Günay', 'Initials': 'DG', 'LastName': 'Canpolat', 'Affiliation': 'Associate Professor in Anesthesiology, Department of Oral and Maxillofacial Surgery, Erciyes University, Kayseri, Turkey. Electronic address: dgcanpolat@gmail.com.'}, {'ForeName': 'Seher Orbay', 'Initials': 'SO', 'LastName': 'Yasli', 'Affiliation': 'Assistant Professor in Anesthesiology, Department of Oral and Maxillofacial Surgery, Erciyes University, Kayseri, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.08.029']
2595,32961531,Effect of the Use of Intranasal Spray of Essential Oils in Patients with Perennial Allergic Rhinitis: A Prospective Study.,"INTRODUCTION


Among allergic rhinitis (AR) symptoms, nasal obstruction particularly affects the quality of life. Antihistamines and intranasal corticosteroids are the most frequently prescribed symptomatic drugs, but their efficacy is often incomplete. Essential oils (EO) have shown an anti-inflammatory effect and potential in treating patients with AR. The aim of this study was to evaluate the effectiveness of a hypertonic EO-based nasal spray on perennial AR (PAR) symptoms.
METHODS


This prospective, open-label, non-randomized, multicentric trial included 43 patients with PAR sensitized to mites, not controlled for more than a year. All were treated with Puressentiel® Respiratory-Decongestant Nasal Spray for 30 days. Their usual treatment remained unchanged during the study period. Before and after treatment, each participant filled out a rhinitis questionnaire, the Allergic Rhinitis Control Test (ARCT). A nasal inspiratory peak flow (NIPF) was performed.
RESULTS


The mean ARCT was 16.4 and 20.5 at D0 and D30, respectively (p < 0.001); the mean increase between D0 and D30 was 4.1 (p < 0.001). The proportion of patients with controlled rhinitis after 30 days of treatment was 69.8 versus 14% before treatment (p < 0.001). The mean NIPF was 86.5 L/min and 105.1 L/min at D0 and D30, respectively (p < 0.001); the mean increase between D0 and D30 was 18.5 L/min.
CONCLUSION


A hypertonic EO-based nasal spray could be a new and natural option in the management of PAR. It could also be used as an add-on therapy when nasal symptoms are not fully controlled.",2020,"The mean ARCT was 16.4 and 20.5 at D0 and D30, respectively (p < 0.001); the mean increase between D0 and D30 was 4.1 (p < 0.001).","['Patients with Perennial Allergic Rhinitis', 'patients with AR', '43 patients with PAR sensitized to mites, not controlled for more than a year']","['Antihistamines and intranasal corticosteroids', 'hypertonic EO-based nasal spray', 'Intranasal Spray of Essential Oils', 'Essential oils (EO', 'Puressentiel® Respiratory-Decongestant Nasal Spray']","['mean NIPF', 'proportion of patients with controlled rhinitis', 'perennial AR (PAR) symptoms', 'mean ARCT', 'nasal inspiratory peak flow (NIPF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0026231', 'cui_str': 'Mite'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0042398', 'cui_str': 'Nasal Decongestants'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0857465', 'cui_str': 'Peak flow'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1272570', 'cui_str': 'Test control'}]",43.0,0.0183154,"The mean ARCT was 16.4 and 20.5 at D0 and D30, respectively (p < 0.001); the mean increase between D0 and D30 was 4.1 (p < 0.001).","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Caimmi', 'Affiliation': 'Department of Pulmonology, Division of Allergy, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, University of Montpellier, Montpellier, France, davide.caimmi@gmail.com.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Neukirch', 'Affiliation': 'Departments of Pneumology A and B and INSERM U1152, Bichat-Claude Bernard University Hospital, Paris, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Louis', 'Affiliation': 'Department of Pulmonary Medicine, CHU Sart-Tilman, IGIGA Research Group, University of Liege, Liège, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Malard', 'Affiliation': ""Service d'ORL et de Chirurgie Cervico-Faciale, University Hospital of Nantes, Hôtel Dieu, Nantes, France.""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Thabut', 'Affiliation': 'Departments of Pneumology A and B and INSERM U1152, Bichat-Claude Bernard University Hospital, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Demoly', 'Affiliation': 'Department of Pulmonology, Division of Allergy, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, University of Montpellier, Montpellier, France.'}]",International archives of allergy and immunology,['10.1159/000510592']
2596,32961537,PATIENT ENGAGEMENT WITH INTERACTIVE TEXT MESSAGE SYSTEM IMPROVES SUCCESSFUL COLONOSCOPY RATES IN AN OUTPATIENT ENDOSCOPY CENTER.,"INTRODUCTION


Text message based interventions reduce colonoscopy no show rates and improved bowel preparation scores. In this non-randomized study, we assessed whether an interactive text messaging system could improve colonoscopy outcomes.
METHODS


Colonoscopy pre-procedural instructions were programmed into a dedicated software platform created for this study. In the intervention arm, text messages were sent to veterans during a 4-week study period. Validated pre-procedural satisfaction questionnaires were completed by patients during standard protocol and intervention periods. Demographics and colonoscopy outcomes data were compared between standard protocol and intervention arms, including procedure completion rate on scheduled date, Boston bowel preparation score (BPPS), adenoma detection rate (ADR), and satisfaction.
RESULTS


Of 241 patients, 128 were in the standard protocol arm and 113 in the intervention arm. Higher proportions receiving text messages underwent colonoscopy on their scheduled date (69.9%) compared to standard protocol (50.8%, p=0.015). Patients with ≥3 interactions with the system had 80.6% likelihood of completing colonoscopy on the scheduled date compared to 56.9% with <3 interactions and 50.8% with standard protocol (p<0.001). Frequency of interaction with the system was similar between older (>65 years) and younger patients (p=1.0). Among older patients, colonoscopy was completed successfully in 84.2% when alert-based human interactions occurred compared to 65.6% in those without and 47.9% with standard protocol (p=0.018). More than 90% indicated they would recommend the system to patients undergoing future colonoscopy.
CONCLUSION


An interactive text messaging system improves successful colonoscopy rates in a VA setting, with greatest impact in older patients.",2020,"Among older patients, colonoscopy was completed successfully in 84.2% when alert-based human interactions occurred compared to 65.6% in those without and 47.9% with standard protocol (p=0.018).","['older patients', '241 patients']",['interactive text messaging system'],"['procedure completion rate on scheduled date, Boston bowel preparation score (BPPS), adenoma detection rate (ADR), and satisfaction', 'successful colonoscopy rates', 'colonoscopy outcomes']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",241.0,0.0943786,"Among older patients, colonoscopy was completed successfully in 84.2% when alert-based human interactions occurred compared to 65.6% in those without and 47.9% with standard protocol (p=0.018).","[{'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Rogers', 'Affiliation': ''}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Shy', 'Affiliation': ''}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Ramgopal', 'Affiliation': ''}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Hengehold', 'Affiliation': ''}, {'ForeName': 'Aymen', 'Initials': 'A', 'LastName': 'Almuhaidb', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weaver', 'Affiliation': ''}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Quader', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Roediger', 'Affiliation': ''}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'C Prakash', 'Initials': 'CP', 'LastName': 'Gyawali', 'Affiliation': ''}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Sayuk', 'Affiliation': ''}]","Digestive diseases (Basel, Switzerland)",['10.1159/000511767']
2597,32961542,Memantine effects on auditory discrimination and training in schizophrenia patients.,"The uncompetitive low-affinity NMDA receptor antagonist, memantine, acutely increases electrophysiological measures of auditory information processing in both healthy subjects (HS) and patients with schizophrenia. Memantine effects on functional measures of auditory discrimination performance and learning are not known; conceivably, beneficial effects on these measures might suggest a role for memantine in augmenting the cognitive and functional impact of auditory targeted cognitive training (TCT). Here, carefully characterized HS (n = 20) and schizophrenia patients (n = 22) were tested in measures of auditory discrimination performance (words-in-noise (WIN), quick speech-in-noise (QuickSIN), gaps-in-noise) and auditory frequency modulation learning (a component of TCT) on 2 days about a week apart, after ingesting either placebo or 20 mg memantine po, in a double-blind, within-subject cross-over random order design. Memantine modestly enhanced functional measures of auditory discrimination in both schizophrenia patients (WIN) and HS (WIN and QuickSIN), as well as auditory frequency modulation learning in schizophrenia patients. These findings converge with a growing literature showing that memantine can enhance a range of metrics of auditory function. These properties could contribute to the apparent benefits of memantine as an adjunctive treatment in schizophrenia, and suggest that memantine might augment learning and potentially clinical gains from auditory-based TCT.",2020,"The uncompetitive low-affinity NMDA receptor antagonist, memantine, acutely increases electrophysiological measures of auditory information processing in both healthy subjects (HS) and patients with schizophrenia.","['healthy subjects (HS) and patients with schizophrenia', 'schizophrenia patients']","['placebo or 20\u2009mg memantine', 'Memantine', 'memantine', 'auditory discrimination performance (words-in-noise (WIN), quick speech-in-noise (QuickSIN), gaps-in-noise) and auditory frequency modulation learning (a component of TCT']","['functional measures of auditory discrimination', 'auditory discrimination and training']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0234747', 'cui_str': 'Sound discrimination'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0234747', 'cui_str': 'Sound discrimination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",22.0,0.0446759,"The uncompetitive low-affinity NMDA receptor antagonist, memantine, acutely increases electrophysiological measures of auditory information processing in both healthy subjects (HS) and patients with schizophrenia.","[{'ForeName': 'Neal R', 'Initials': 'NR', 'LastName': 'Swerdlow', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA. nswerdlow@health.ucsd.edu.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Bhakta', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Talledo', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Kotz', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Roberts', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Royce Ellen', 'Initials': 'RE', 'LastName': 'Clifford', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Yash', 'Initials': 'Y', 'LastName': 'Joshi', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Juan L', 'Initials': 'JL', 'LastName': 'Molina', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Light', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of California, San Diego, La Jolla, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00865-8']
2598,32961568,Evaluation of Efficacy of Coenzyme Q10 as an Adjunct to Nonsurgical Periodontal Therapy and Its Effect on Crevicular Superoxide Dismutase in Patients with Chronic Periodontitis.,"OBJECTIVES


To assess the efficacy of coenzyme Q10 (CoQ10) as an adjunct to nonsurgical periodontal therapy and its effect on superoxide dismutase (SOD) in gingival crevicular fluid (GCF) in patients with chronic periodontitis (CP).
MATERIALS AND METHODS


A total of 16 patients aged between 30 and 50 years having mild to moderate CP of both sexes having pocket depth of 5 to 7 mm in four nonadjacent interproximal sites were selected. The sites were randomized and divided into treatment and control groups. CoQ10 and a placebo gel were administered in the treatment and control sites, respectively, at baseline after scaling and root planing (SRP). GCF was collected using microcapillary method at baseline and 3 months and was assessed for SOD using enzyme-linked immunosorbent assay reader at 450 nm wavelength. Probing pocket depth, gingival index, and plaque index were assessed at baseline, 1 month, and 3 months, respectively.
STATISTICAL ANALYSIS


For each assessment point, data were statistically analyzed using Student's  t -test and paired  t -test. Level of significance was set at  p  < 0.05.
RESULTS


On intergroup comparison, there was no statistically significant difference between the clinical parameters of both the groups at all the time intervals ( p  > 0.05), but there was a significant increase in the level of SOD in the test group ( p  > 0.05) compared with the control group at 3 months.
CONCLUSIONS


Adjunctive use of CoQ10 with SRP can boost the antioxidant concentration, but it is not superior to SRP in the treatment of CP.",2020,"On intergroup comparison, there was no statistically significant difference between the clinical parameters of both the groups at all the time intervals ( p  > 0.05), but there was a significant increase in the level of SOD in the test group ( p  > 0.05) compared with the control group at 3 months.
","['Patients with Chronic Periodontitis', 'patients with chronic periodontitis (CP', '16 patients aged between 30 and 50 years having mild to moderate CP of both sexes having pocket depth of 5 to 7 mm in four nonadjacent interproximal sites were selected']","['placebo gel', 'Coenzyme Q10', 'CoQ10 with SRP', 'coenzyme Q10 (CoQ10']","['superoxide dismutase (SOD', 'Probing pocket depth, gingival index, and plaque index', 'Crevicular Superoxide Dismutase', 'level of SOD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",16.0,0.0280619,"On intergroup comparison, there was no statistically significant difference between the clinical parameters of both the groups at all the time intervals ( p  > 0.05), but there was a significant increase in the level of SOD in the test group ( p  > 0.05) compared with the control group at 3 months.
","[{'ForeName': 'Swagat', 'Initials': 'S', 'LastName': 'Pranam', 'Affiliation': 'Department of Periodontology, Manav Rachna Dental College, Haryana, India.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Palwankar', 'Affiliation': 'Department of Periodontology, Manav Rachna Dental College, Haryana, India.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Pandey', 'Affiliation': 'Department of Periodontology, Manav Rachna Dental College, Haryana, India.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Goyal', 'Affiliation': 'Department of Periodontology, Manav Rachna Dental College, Haryana, India.'}]",European journal of dentistry,['10.1055/s-0040-1716596']
2599,32961875,Tele-Assisted Behavioral Intervention for Families with Children with Autism Spectrum Disorders: A Randomized Control Trial.,"BACKGROUND


Telehealth is useful for both autism spectrum disorder (ASD) diagnosis and treatment, but studies with a direct comparison between teletherapy and traditional in-person therapy are limited.
METHODS


This randomized control trial-ISRCTN (International Standard Randomised Controlled Trial Number) primary clinical trial registry ID ISRCTN15312724-was aimed at comparing the effect of a tele-assisted and in-person intervention based on a behavioral intervention protocol for families with children affected by ASDs. Forty-two parents with children with autism (30 months to 10 years old) were randomly assigned to 12 sessions of an applied behavioral analysis (ABA) intervention implemented in an individual and group setting, either with or without the inclusion of tele-assistance. Pre- and postintervention assessments were conducted using the Home Situation Questionnaire (HSQ-ASD) and the Parental Stress Index (PSI/SF).
RESULTS


Substantial improvements in the perception and management of children's behavior by parents, as well as in the influence of a reduction in parent stress levels on said children's behavior through the use of a tele-assisted intervention, were obtained.
CONCLUSIONS


This randomized controlled trial demonstrates the evidence-based potential for telehealth to improve treatment of ASDs.",2020,"Pre- and postintervention assessments were conducted using the Home Situation Questionnaire (HSQ-ASD) and the Parental Stress Index (PSI/SF).
","['Families with Children with Autism', 'families with children affected by ASDs', 'Spectrum Disorders', 'Forty-two parents with children with autism (30 months to 10 years old']","['behavioral intervention protocol', 'Tele-Assisted Behavioral Intervention', 'tele-assisted and in-person intervention', 'applied behavioral analysis (ABA) intervention implemented in an individual and group setting, either with or without the inclusion of tele-assistance']",['Home Situation Questionnaire (HSQ-ASD) and the Parental Stress Index (PSI/SF'],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C1999012', 'cui_str': 'Parental role conflict'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439472', 'cui_str': 'lb/sq. in'}]",42.0,0.120457,"Pre- and postintervention assessments were conducted using the Home Situation Questionnaire (HSQ-ASD) and the Parental Stress Index (PSI/SF).
","[{'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Marino', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Chilà', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Failla', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Crimi', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Minutoli', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Alfio', 'Initials': 'A', 'LastName': 'Puglisi', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Antonino Andrea', 'Initials': 'AA', 'LastName': 'Arnao', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Tartarisco', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Ruta', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vagni', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Pioggia', 'Affiliation': 'Institute for Biomedical Research and Innovation (IRIB), National Research Council of Italy (CNR), 98164 Messina, Italy.'}]",Brain sciences,['10.3390/brainsci10090649']
2600,32961878,Poor Sleep Quality Decreases Concurrent Training Benefits in Markers of Metabolic Syndrome and Quality of Life of Morbidly Obese Patients.,"Background:  Sleep quality (SQ) plays a role in multiple activities of daily living, but little is known about its role in concurrent training [CT, high-intensity interval (HIIT) plus resistance training (RT)] adaptations for metabolic syndrome (MetS) and health-related quality of life (HRQoL) markers. The aim of the present study was to determine the effects of a 20-week CT programme on MetS and HRQoL markers according to the SQ of morbidly obese patients.  Methods:  Twenty-nine morbidly obese patients were allocated to one of two groups: good sleep quality (GSQ, n = 15, 38.07 ± 12.26 years) and poor sleep quality (PSQ, n = 14, 40.79 ± 11.62 years). HRQoL, body mass index, waist circumference (WC), systolic and diastolic blood pressure (SDP and DBP, respectively), and plasma outcomes were measured.  Results:  The GSQ group reported significant changes (pre- vs. post-intervention) in WC (114.0 ± 3.1 vs. 110.4 ± 3.4 cm, p = 0.012), systolic blood pressure (SBP) (137.0 ± 4.3 vs. 125.6 ± 1.8 mmHg, p = 0.006), and HRQoL general health (51.33 ± 21.08 vs. 64.33 ± 16.24, p = 0.020). By contrast, the PSQ group showed significant changes only in SQ (9.00 ± 2.42 vs. 5.36 ± 2.84, p = 0.004).  Conclusions:  Morbidly obese PSQ patients showed a lower response for improving MetS and HRQoL markers after a 20-week CT programme than GSQ peers. However, there was a greater effect size for decreasing WC and SBP in favour of the GSQ compared with the PSQ group, suggesting that there are limitations to CT benefits on these outcomes in the PSQ group. These results call for more complex future studies.",2020,Morbidly obese PSQ patients showed a lower response for improving MetS and HRQoL markers after a 20-week CT programme than GSQ peers.,"['Morbidly obese PSQ patients', 'morbidly obese patients', 'Morbidly Obese Patients', 'Twenty-nine morbidly obese patients']","['PSQ', 'GSQ', '20-week CT programme']","['MetS and HRQoL markers', 'systolic blood pressure (SBP', 'good sleep quality', 'HRQoL general health', 'HRQoL, body mass index, waist circumference (WC), systolic and diastolic blood pressure (SDP and DBP, respectively), and plasma outcomes', 'poor sleep quality']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450351', 'cui_str': '29'}]","[{'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",29.0,0.0506513,Morbidly obese PSQ patients showed a lower response for improving MetS and HRQoL markers after a 20-week CT programme than GSQ peers.,"[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Delgado-Floody', 'Affiliation': 'Department of Physical Education, Sport and Recreation, Universidad de La Frontera, Temuco 4780000, Chile.'}, {'ForeName': 'Pedro Ángel', 'Initials': 'PÁ', 'LastName': 'Latorre-Román', 'Affiliation': 'Department of Didactics of Corporal Expression, University of Jaen, 23400 Jaen, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jerez-Mayorga', 'Affiliation': 'Faculty of Rehabilitation Sciences, Universidad Andres Bello, Santiago 7591538, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Caamaño-Navarrete', 'Affiliation': 'Faculty of Education, Universidad Católica de Temuco, Temuco 4780000, Chile.'}, {'ForeName': 'Johnattan', 'Initials': 'J', 'LastName': 'Cano-Montoya', 'Affiliation': 'School of Kinesiology, Faculty of Health Sciences, Universidad San Sebastian, Valdivia 5090000, Chile.'}, {'ForeName': 'José Alberto', 'Initials': 'JA', 'LastName': 'Laredo-Aguilera', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Carmona-Torres', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Cobo-Cuenca', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Diana P', 'Initials': 'DP', 'LastName': 'Pozuelo-Carrascosa', 'Affiliation': 'Multidisciplinary Research Group in Care (IMCU), Universidad de Castilla-La Mancha, 45004 Toledo, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Álvarez', 'Affiliation': 'Quality of Life and Wellness Research Group API4, Laboratory of Human Performance, Department of Physical Activity Sciences, Universidad de Los Lagos, Osorno 5290000, Chile.'}]",International journal of environmental research and public health,['10.3390/ijerph17186804']
2601,32961895,A Quality Control System for Automated Prostate Segmentation on T2-Weighted MRI.,"Computer-aided detection and diagnosis (CAD) systems have the potential to improve robustness and efficiency compared to traditional radiological reading of magnetic resonance imaging (MRI). Fully automated segmentation of the prostate is a crucial step of CAD for prostate cancer, but visual inspection is still required to detect poorly segmented cases. The aim of this work was therefore to establish a fully automated quality control (QC) system for prostate segmentation based on T2-weighted MRI. Four different deep learning-based segmentation methods were used to segment the prostate for 585 patients. First order, shape and textural radiomics features were extracted from the segmented prostate masks. A reference quality score (QS) was calculated for each automated segmentation in comparison to a manual segmentation. A least absolute shrinkage and selection operator (LASSO) was trained and optimized on a randomly assigned training dataset (N = 1756, 439 cases from each segmentation method) to build a generalizable linear regression model based on the radiomics features that best estimated the reference QS. Subsequently, the model was used to estimate the QSs for an independent testing dataset (N = 584, 146 cases from each segmentation method). The mean ± standard deviation absolute error between the estimated and reference QSs was 5.47 ± 6.33 on a scale from 0 to 100. In addition, we found a strong correlation between the estimated and reference QSs (rho = 0.70). In conclusion, we developed an automated QC system that may be helpful for evaluating the quality of automated prostate segmentations.",2020,Computer-aided detection and diagnosis (CAD) systems have the potential to improve robustness and efficiency compared to traditional radiological reading of magnetic resonance imaging (MRI).,[],['Computer-aided detection and diagnosis (CAD) systems'],"['mean ± standard deviation absolute error', 'reference quality score (QS']",[],"[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1756.0,0.0220048,Computer-aided detection and diagnosis (CAD) systems have the potential to improve robustness and efficiency compared to traditional radiological reading of magnetic resonance imaging (MRI).,"[{'ForeName': 'Mohammed R S', 'Initials': 'MRS', 'LastName': 'Sunoqrot', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway.'}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Selnæs', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Sandsmark', 'Affiliation': 'Department of Radiology and Nuclear Medicine, St. Olavs Hospital, Trondheim University Hospital, 7030 Trondheim, Norway.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Nketiah', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway.'}, {'ForeName': 'Olmo', 'Initials': 'O', 'LastName': 'Zavala-Romero', 'Affiliation': 'Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, FL 33136, USA.'}, {'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Stoyanova', 'Affiliation': 'Department of Radiation Oncology, University of Miami Miller School of Medicine, Miami, FL 33136, USA.'}, {'ForeName': 'Tone F', 'Initials': 'TF', 'LastName': 'Bathen', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway.'}, {'ForeName': 'Mattijs', 'Initials': 'M', 'LastName': 'Elschot', 'Affiliation': 'Department of Circulation and Medical Imaging, NTNU-Norwegian University of Science and Technology, 7030 Trondheim, Norway.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10090714']
2602,32962031,"Perspectives and Impact of a Parent-Child Intervention on Dietary Intake and Physical Activity Behaviours, Parental Motivation, and Parental Body Composition: A Randomized Controlled Trial.","Adults and children in Canada are not meeting physical activity guidelines nor consuming sufficient nutrient-rich foods. High engagement in these unhealthy behaviours can lead to obesity and its associated diseases. Parent-child interventions aimed at obesity prevention/treatment have assisted families with making positive changes to their nutrition and physical activity behaviours. Given that the home environment shapes early health behaviours, it is important to target both parents and children when addressing diet and physical activity. One method that has been shown to improve health outcomes is co-active coaching. The current study explored the impact of a three-month co-active coaching and/or health education intervention on the dietary intake and physical activity behaviours of parents with overweight/obesity and their children (ages 2.5-10; of any weight). Body composition (i.e., body mass index [BMI] and waist circumference), changes in parental motivation with respect to physical activity and dietary behaviours, and parental perceptions of program improvements were collected. A concurrent mixed methods study comprised of a randomized controlled trial and a descriptive qualitative design was utilized. Fifty parent-child dyads were recruited and randomly assigned to the control ( n  = 25) or intervention ( n  = 25) group. Assessments were completed at baseline, mid-intervention (six weeks), post-intervention (three months), and six-month follow-up. A linear mixed effects model was utilized for quantitative analysis. Inductive content analysis was used to extract themes from parent interviews. No significant results were observed over time for the dependent measures. Parents in both control and intervention groups reported varied program experiences, including developing changes in perspective, increased awareness of habits, and heightened accountability for making positive changes in themselves, and consequently, their families. Parents also shared barriers they faced when implementing changes (e.g., time, weather, stress). Qualitatively, both groups reported benefitting from this program, with the intervention group describing salient benefits from engaging in coaching. This research expands on the utility of coaching as a method for behaviour change, when compared to education only, in parents with overweight/obesity and their children.",2020,"Parents in both control and intervention groups reported varied program experiences, including developing changes in perspective, increased awareness of habits, and heightened accountability for making positive changes in themselves, and consequently, their families.","['parents with overweight/obesity and their children (ages 2.5-10; of any weight', 'Fifty parent-child dyads', 'parents with overweight/obesity and their children', 'Adults and children in Canada']","['Parent-Child Intervention', 'three-month co-active coaching and/or health education intervention']","['health outcomes', 'Body composition (i.e., body mass index', 'BMI] and waist circumference), changes in parental motivation with respect to physical activity and dietary behaviours, and parental perceptions of program improvements', 'Dietary Intake and Physical Activity Behaviours, Parental Motivation, and Parental Body Composition', 'dietary intake and physical activity behaviours']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",,0.031059,"Parents in both control and intervention groups reported varied program experiences, including developing changes in perspective, increased awareness of habits, and heightened accountability for making positive changes in themselves, and consequently, their families.","[{'ForeName': 'Shazya', 'Initials': 'S', 'LastName': 'Karmali', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Battram', 'Affiliation': 'Food and Nutritional Sciences, Western University, Brescia University College, London, ON N6G 1H2, Canada.'}, {'ForeName': 'Shauna M', 'Initials': 'SM', 'LastName': 'Burke', 'Affiliation': 'School of Health Studies, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Cramp', 'Affiliation': 'Middlesex London Health Unit, London, ON N6A 3N7, Canada.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Mantler', 'Affiliation': 'School of Health Studies, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Morrow', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Ng', 'Affiliation': 'Department of Programs and Practice Support, College of Family Physicians of Canada, Mississauga, ON L4W 5A4, Canada.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Pearson', 'Affiliation': 'School of Kinesiology, Faculty of Health and Behavioural Sciences, Lakehead University, Thunder Bay, ON P7B 5E1, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Petrella', 'Affiliation': 'Department of Family Practice, Faculty of Medicine, University of British Columbia, Vancouver, BC V6T 1Z3, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Tucker', 'Affiliation': 'School of Occupational Therapy, Western University, London, ON N6A 3K7, Canada.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Irwin', 'Affiliation': 'Health & Rehabilitation Sciences, Western University, London, ON N6A 3K7, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17186822']
2603,32964829,The treatment of mild OSA with CPAP or mandibular advancement device and the effect on blood pressure and endothelial function after one year of treatment.,"STUDY OBJECTIVES


To evaluate and compare the effects of continuous positive airway pressure (CPAP), use of a mandibular advancement device (MAD), and no treatment on 24-h ambulatory blood pressure monitoring (ABPM) and peripheral arterial tonometry (PAT) at 6 and 12 months follow-up in individuals with mild obstructive sleep apnea (OSA), and in subgroup who had an AHI of < 5 and adherence of ≥ 4 hours per night (effective treatment subgroups).
METHODS


The inclusion criteria were individuals with mild OSA, any gender, aged between 18 and 65 years, with a BMI of ≤ 35Kg/m². Patients were randomized into CPAP, MAD and no-treatment groups. The evaluations included physical examination, full polysomnography, 24-h ABPM and PAT at baseline, after 6 and 12 months. A generalized linear mixed model was used for comparisons.
RESULTS


The CPAP and MAD groups had lower AHIs than the control group at 6 and 12 months, and the CPAP group had higher SpO2 than the MAD group. The MAD group had more hours of treatment per night and better adaptation to treatment than the CPAP group (MAD: 5.7 ± 2.7 h/per night; CPAP: 3.8 ± 3.4 h/per night; MAD: 16% did not adapt; CPAP: 42% did not adapt). No differences were found in the total sample and effective treatment in relation to PAT or 24-h ABPM outcomes.
CONCLUSIONS


Treatment of mild OSA with CPAP or MAD did not improve BP or endothelial function after one year, even in patients with effective treatment.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov, Title: Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea, Identifier: NCT01461486, URL: https://clinicaltrials.gov/ct2/show/NCT01461486.",2020,"The CPAP and MAD groups had lower AHIs than the control group at 6 and 12 months, and the CPAP group had higher SpO2 than the MAD group.","['The inclusion criteria were individuals with mild OSA, any gender, aged between 18 and 65 years, with a BMI of ≤ 35Kg/m²', 'individuals with mild obstructive sleep apnea (OSA), and in subgroup who had an AHI of < 5 and adherence of ≥ 4 hours per night (effective treatment subgroups']","['CPAP', 'continuous positive airway pressure (CPAP', 'CPAP or MAD', 'mandibular advancement device (MAD']","['total sample and effective treatment in relation to PAT or 24-h ABPM outcomes', 'blood pressure and endothelial function', '24-h ambulatory blood pressure monitoring (ABPM) and peripheral arterial tonometry (PAT', 'physical examination, full polysomnography, 24-h ABPM and PAT', 'BP or endothelial function']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C2091299', 'cui_str': 'Mandibular Advancement Devices'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]",,0.0510309,"The CPAP and MAD groups had lower AHIs than the control group at 6 and 12 months, and the CPAP group had higher SpO2 than the MAD group.","[{'ForeName': 'Thais Moura', 'Initials': 'TM', 'LastName': 'Guimarães', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de Sao Paulo, São Paulo, Brasil.'}, {'ForeName': 'Dalva', 'Initials': 'D', 'LastName': 'Poyares', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de Sao Paulo, São Paulo, Brasil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Oliveira E Silva', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de Sao Paulo, São Paulo, Brasil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Luz', 'Affiliation': 'Departamento de Pneumologia, Universidade Federal de Sao Paulo, São Paulo, Brasil.'}, {'ForeName': 'Glaury', 'Initials': 'G', 'LastName': 'Coelho', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de Sao Paulo, São Paulo, Brasil.'}, {'ForeName': 'Cibele Dal', 'Initials': 'CD', 'LastName': 'Fabbro', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de Sao Paulo, São Paulo, Brasil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Tufik', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de Sao Paulo, São Paulo, Brasil.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bittencourt', 'Affiliation': 'Departamento de Psicobiologia, Universidade Federal de Sao Paulo, São Paulo, Brasil.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8822']
2604,32065309,Bupivacaine vs. lidocaine: a comparison of local anesthetic efficacy in impacted third molar surgery.,"OBJECTIVES


The aim of this study was to compare the anesthetic efficacy, the duration of anesthesia, and the postoperative analgesia of lidocaine and bupivacaine and to determine any difference in hemodynamic parameters in patients who required impacted third molar removal.
MATERIALS AND METHODS


Thirty-eight patients between the ages of 18 and 40, with no systemic disease, were included in the study, with an indication of impacted lower third molar extraction. One of two local anesthetic agents (Marcaine and Jetokain Simplex) was randomly selected for tooth extractions. The parameters evaluated were the onset of anesthetic agent action, the duration of operation, the duration of postoperative analgesia, and postoperative visual analog scale scores. Hemodynamic parameters were observed and evaluated preoperatively and during the operation. All data were evaluated statistically.
RESULTS


When the time of anesthesia onset was analyzed according to both anesthetic solutions, the difference was in favor of lidocaine (p = 0.01). The duration of action was longer in the bupivacaine group than in the lidocaine group (p = 0.00002). VAS values for the pain obtained during injection were lower in the lidocaine group (p = 0.009).However, according to the results of our study, the postoperative analgesic efficacy of bupivacaine is similar to that of lidocaine (p = 0.087).
CONCLUSION


After evaluation of these results, we can recommend the use of lidocaine and bupivacaine safely in dentistry practice. But long-duration effect of bupivacaine and the rapid effect of lidocaine may make lidocaine more preferable.
CLINICAL RELEVANCE


It is important to determine the clinically effective and safe anesthetic solution.",2020,"VAS values for the pain obtained during injection were lower in the lidocaine group (p = 0.009).However, according to the results of our study, the postoperative analgesic efficacy of bupivacaine is similar to that of lidocaine (p = 0.087).
","['patients who required impacted third molar removal', 'Thirty-eight patients between the ages of 18 and 40, with no systemic disease, were included in the study, with an indication of impacted lower third molar extraction', 'impacted third molar surgery']","['bupivacaine', 'local anesthetic agents (Marcaine and Jetokain Simplex', 'Bupivacaine vs. lidocaine', 'lidocaine and bupivacaine', 'lidocaine']","['postoperative analgesic efficacy', 'duration of action', 'onset of anesthetic agent action, the duration of operation, the duration of postoperative analgesia, and postoperative visual analog scale scores', 'Hemodynamic parameters', 'local anesthetic efficacy', 'anesthetic efficacy', 'hemodynamic parameters', 'VAS values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C2945665', 'cui_str': 'Marcaine'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",38.0,0.0336274,"VAS values for the pain obtained during injection were lower in the lidocaine group (p = 0.009).However, according to the results of our study, the postoperative analgesic efficacy of bupivacaine is similar to that of lidocaine (p = 0.087).
","[{'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Velioglu', 'Affiliation': 'Faculty of Dentistry, Oral Surgery Department, Ege University, Bornova, Izmir, Turkey.'}, {'ForeName': 'Aylin Sipahi', 'Initials': 'AS', 'LastName': 'Calis', 'Affiliation': 'Faculty of Dentistry, Oral Surgery Department, Ege University, Izmir, Turkey. aysipahi@gmail.com.'}, {'ForeName': 'Huseyin', 'Initials': 'H', 'LastName': 'Koca', 'Affiliation': 'Faculty of Dentistry, Oral Surgery Department, Ege University, Izmir, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Velioglu', 'Affiliation': 'Faculty of Dentistry, Prosthetic Dentistry Department, İzmir Katip Celebi University, Izmır, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03224-5']
2605,30617849,"Self-initiated continuation of and adherence to HIV pre-exposure prophylaxis (PrEP) after PrEP demonstration project roll-off in men who have sex with men: associations with risky decision making, impulsivity/disinhibition, and sensation seeking.","The objective of this study was to examine differences in the levels of risky decision making and other frontal system behavior constructs in relation to self-initiated continuance of HIV pre-exposure prophylaxis (PrEP) and PrEP adherence outcomes among men who have sex with men (MSM) following completion of a clinical PrEP trial. At the last PrEP trial visit, study provided PrEP was discontinued and participants were navigated to the community for PrEP continuation. In this cross-sectional analysis, 84/187 (45%) MSM who completed a prospective observational post-PrEP trial follow-up visit at the University of California San Diego were included. PrEP adherence was measured using dried blood spot tenofovir diphosphate (TFV-DP) levels. Risky decision making was assessed using the Iowa Gambling Task (IGT) and the Balloon Analogue Risk Task (BART), while impulsivity/disinhibition, sensation seeking, and substance use were assessed via standardized self-report questionnaires. A total of 58/84 (69%) of MSM who completed the 12-month post-study visit continued PrEP. Of those, n = 46 (79%) reached TFV-DP levels associated with adequate adherence. Individuals who elected to continue PrEP 12 months post-trial had riskier decision making on BART, but less impulsivity/disinhibition compared to individuals who did not continue PrEP. Neither risky decision making nor impulsivity/disinhibition/sensation seeking nor substance use correlated with PrEP adherence. Our findings suggest that those with risky decision making may have greater insight into their HIV risks, and therefore be more likely to continue to use PrEP. However, elevated impulsivity/disinhibition, indicative of greater neurobehavioral alterations, was negatively associated with PrEP continuance and is a potential target for future interventions to help people link to PrEP.",2019,"Individuals who elected to continue PrEP 12 months post-trial had riskier decision making on BART, but less impulsivity/disinhibition compared to individuals who did not continue PrEP.","['84/187 (45%) MSM who completed a prospective observational post-PrEP trial follow-up visit at the University of California San Diego were included', 'men who have sex with men', 'men who have sex with men (MSM) following completion of a clinical PrEP trial']","['Self-initiated continuation of and adherence to HIV pre-exposure prophylaxis (PrEP', 'HIV pre-exposure prophylaxis (PrEP']","['dried blood spot tenofovir diphosphate (TFV-DP) levels', 'Iowa Gambling Task (IGT) and the Balloon Analogue Risk Task (BART), while impulsivity/disinhibition, sensation seeking, and substance use', 'impulsivity/disinhibition', 'PrEP adherence', 'TFV-DP levels']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0662582,"Individuals who elected to continue PrEP 12 months post-trial had riskier decision making on BART, but less impulsivity/disinhibition compared to individuals who did not continue PrEP.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hoenigl', 'Affiliation': 'University of California San Diego (UCSD), San Diego, CA, USA. mhoenigl@ucsd.edu.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Morgan', 'Affiliation': 'University of California San Diego (UCSD), San Diego, CA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Franklin', 'Affiliation': 'University of California San Diego (UCSD), San Diego, CA, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pasipanodya', 'Affiliation': 'University of California San Diego (UCSD), San Diego, CA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dawson', 'Affiliation': 'University of California San Diego (UCSD), San Diego, CA, USA.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Hanashiro', 'Affiliation': 'University of California San Diego (UCSD), San Diego, CA, USA.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Ellorin', 'Affiliation': 'University of California San Diego (UCSD), San Diego, CA, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Blumenthal', 'Affiliation': 'University of California San Diego (UCSD), San Diego, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Heaton', 'Affiliation': 'University of California San Diego (UCSD), San Diego, CA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Moore', 'Affiliation': 'University of California San Diego (UCSD), San Diego, CA, USA.'}, {'ForeName': 'Sheldon R', 'Initials': 'SR', 'LastName': 'Morris', 'Affiliation': 'University of California San Diego (UCSD), San Diego, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurovirology,['10.1007/s13365-018-0716-3']
2606,32962055,"Breastfeeding at 1, 3 and 6 Months after Birth According to the Mode of Birth: A Correlation Study.","BACKGROUND


Breastfeeding is a determinant of child and maternal health. However, evidence is limited on how mode of birth influences breastfeeding. Research aim: To examine the mode of birth and breastfeeding duration and the type of lactation at one, three and six months after birth in XXX, during 2017.
METHODS


Correlation study on breastfeeding duration and type of lactation during the six months after birth, and mode of birth, in a randomised sample. Women ≥18 years of age with term singleton infants, were included. Collected data through interviews and hospital records. Pearson's and Spearman's correlation analyses were conducted. SPSSv21 and α = 0.05 were used.
RESULTS


Breastfeeding duration was shorter in women with greater parity (-0.055 **) ( p  < 0.01) and epidural analgesia (0.057 **) ( p  < 0.01), and longer in mothers with episiotomy (-0.267 **) ( p  < 0.01). Episiotomy was associated with breastfeeding at one month (0.112 **) ( p  < 0.01), and at six months (0.347 *) ( p  < 0.01). The prevalence of breastfeeding was lower in women who received epidural analgesia at three months (-0.140 **) ( p  < 0.01) and higher at six months (0.013 **) ( p  < 0.01). The percentages of breastfeeding at three months were significantly greater in women with no perineal tears (2.1) ( p  < 0.05). At six months, small rates of breastfeeding were found in women with greater parity (0.051 **) ( p  < 0.01). No significant association was detected, neither between the type of lactation and the mode of birth, nor between breastfeeding duration and the mode of birth.
CONCLUSIONS


Epidural analgesia, episiotomy, perineal tears and parity influence the type of lactation and duration of breastfeeding during the six months after birth. The results suggest no association between the type of lactation and the mode of birth or between breastfeeding duration and the mode of birth.",2020,The prevalence of breastfeeding was lower in women who received epidural analgesia at three months (-0.140,"['women with greater parity ', 'Women ≥18 years of age with term singleton infants']",['epidural analgesia'],"['small rates of breastfeeding', 'Episiotomy', 'percentages of breastfeeding', 'type of lactation and the mode of birth, nor between breastfeeding duration and the mode of birth', 'epidural analgesia', 'prevalence of breastfeeding']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.0335807,The prevalence of breastfeeding was lower in women who received epidural analgesia at three months (-0.140,"[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Agea-Cano', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Linares-Abad', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'Antonio Gregorio', 'Initials': 'AG', 'LastName': 'Ceballos-Fuentes', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Calero-García', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, University of Jaén, 23071 Jaén, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186828']
2607,32962057,Effects of Simulation Practicum Using Flipped Learning for Korean Nursing Students.,"This study aimed to examine the effects of simulation practicum using flipped learning on nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and learning satisfaction of Korean nursing students. This study used a quasi-experimental pretest-posttest control group design. The samples used were from 101 nursing students (Intervention 1:  n  = 34; Intervention 2:  n  = 34; Control:  n  = 33) over 20 years old in G provinces, Korea. For the experimental interventions, participants in the intervention group 1 were applied by simulation practicum using flipped learning, and those in intervention group 2 were applied by simulation practicum. Participants in the control group were applied by lecture-based practicum using a model. The measures were the study participants' general characteristics survey, the nursing competency scale, the core basic nursing skill (subcutaneous injection) performance scale, the self-efficacy scale, and the learning satisfaction scale. There were statistically significant differences in nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction among the three groups. It was seen in this study that simulation practicum using flipped learning was the most effective teaching and learning method for the nursing practicum of Korean nursing students. The simulation practicum using flipped learning can be useful in providing nursing practicum to nursing students.",2020,"There were statistically significant differences in nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction among the three groups.","['101 nursing students (Intervention 1:  n  = 34', 'Korean Nursing Students', 'Korean nursing students']","['Intervention 2:  n  = 34; Control:  n  = 33) over 20 years old in G provinces, Korea', 'Simulation Practicum Using Flipped Learning', 'simulation practicum using flipped learning', 'simulation practicum using flipped learning, and those in intervention group 2 were applied by simulation practicum']","['nursing competency scale, the core basic nursing skill (subcutaneous injection) performance scale, the self-efficacy scale, and the learning satisfaction scale', 'nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction', 'nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and learning satisfaction']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",101.0,0.0135524,"There were statistically significant differences in nursing competency, core basic nursing skill (subcutaneous injection) performance, self-efficacy, and the learning satisfaction among the three groups.","[{'ForeName': 'Minkyung', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'Department of Nursing, College of Science and Technology, Daejin University, Pocheon-si, Gyeonggi-do 11159, Korea.'}, {'ForeName': 'Sohyune R', 'Initials': 'SR', 'LastName': 'Sok', 'Affiliation': 'College of Nursing Science, Kyung Hee University, Seoul 02447, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186829']
2608,32962176,Predictors of Changes in Alcohol Craving Levels during a Virtual Reality Cue Exposure Treatment among Patients with Alcohol Use Disorder.,"BACKGROUND/OBJECTIVE


Determining the predictive variables associated with levels of alcohol craving can ease the identification of patients who can benefit from treatments. This study aimed to describe changes (improvement or no change/deterioration) in alcohol craving levels and explore the predictors of these changes from admission to discharge in outpatients with alcohol use disorder (AUD) undergoing treatment-as-usual (TAU), or treatment-as-usual supplemented with virtual reality cue-exposure therapy (TAU + VR-CET).
METHOD


A prospective cohort study was conducted amongst 42 outpatients with AUD (n = 15 TAU + VR-CET and n = 27 TAU) from a clinical setting. Changes in the levels of alcohol craving between admission and discharge were assessed with the Multidimensional Alcohol Craving Scale. Sociodemographic characteristics (age, gender, education, and socioeconomic and civil status), cognitive-affective behavioral patterns (AUD severity, abstinence duration, psychiatric comorbidity, state anxiety, attentional bias, and substance use), and type of treatment (TAU + VR-CET and only TAU) were also evaluated.
RESULTS


The TAU + VR-CET group showed greater changes of improvement in the levels of alcohol craving than the TAU group (χ 2  = 10.996;  p  = 0.001). Intragroup changes in alcohol craving from pre to post-treatment were significant in the TAU + VR-CET group (χ 2  = 13.818;  p  = 0.003) but not within the TAU group (χ 2  = 2.349;  p  = 0.503). The odds of an improvement in any of the craving levels between pre- and post-test was 18.18 (1/0.055) times higher in the TAU + VR-CET group with respect to the TAU group. The use of illicit drugs in the month prior to the test increased the odds of having a positive change by 18.18 (1/0.055) with respect to not having consumed.
CONCLUSIONS


Including VR-CET in TAU programs may provide benefits in the treatment of AUDs mainly among patients with intense alcohol craving and individuals having used illicit substances prior to treatment.",2020,Intragroup changes in alcohol craving from pre to post-treatment were significant in the TAU + VR-CET group (χ 2  = 13.818;  p  = 0.003) but not within the TAU group (χ 2  = 2.349;  p  = 0.503).,"['Patients with Alcohol Use Disorder', '42 outpatients with AUD (n = 15 TAU + VR-CET and n = 27 TAU) from a clinical setting', 'outpatients with alcohol use disorder (AUD) undergoing treatment-as-usual (TAU), or treatment-as-usual supplemented with', 'patients with intense alcohol craving and individuals having used illicit substances prior to treatment']","['virtual reality cue-exposure therapy (TAU + VR-CET', 'Virtual Reality Cue Exposure Treatment']","['Multidimensional Alcohol Craving Scale', 'Sociodemographic characteristics (age, gender, education, and socioeconomic and civil status), cognitive-affective behavioral patterns (AUD severity, abstinence duration, psychiatric comorbidity, state anxiety, attentional bias, and substance use), and type of treatment (TAU + VR-CET and only TAU', 'alcohol craving', 'levels of alcohol craving', 'craving levels', 'Alcohol Craving Levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007735', 'cui_str': 'Cephalothin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",42.0,0.0146005,Intragroup changes in alcohol craving from pre to post-treatment were significant in the TAU + VR-CET group (χ 2  = 13.818;  p  = 0.003) but not within the TAU group (χ 2  = 2.349;  p  = 0.503).,"[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hernández-Serrano', 'Affiliation': ""Department of Physical Therapy, Escola Universitària de la Salut i l'Esport (EUSES)-University of Girona, Carrer Francesc Macià, 65, Campus of Salt, 17190 Girona PC, Spain.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ghiţă', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Natàlia', 'Initials': 'N', 'LastName': 'Figueras-Puigderrajols', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'Fernández-Ruiz', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Monras', 'Affiliation': 'Addictive Behaviors Unit, Hospital Clinic of Barcelona, Carrer de Villarroel, 170, 08036 Barcelona PC, Spain.'}, {'ForeName': 'Lluïsa', 'Initials': 'L', 'LastName': 'Ortega', 'Affiliation': 'Addictive Behaviors Unit, Hospital Clinic of Barcelona, Carrer de Villarroel, 170, 08036 Barcelona PC, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mondon', 'Affiliation': 'Addictive Behaviors Unit, Hospital Clinic of Barcelona, Carrer de Villarroel, 170, 08036 Barcelona PC, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Teixidor', 'Affiliation': 'Addictive Behaviors Unit, Hospital Clinic of Barcelona, Carrer de Villarroel, 170, 08036 Barcelona PC, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Gual', 'Affiliation': 'Addictive Behaviors Unit, Hospital Clinic of Barcelona, Carrer de Villarroel, 170, 08036 Barcelona PC, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Ugas-Ballester', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Fernández', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Montserrat', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Porras-Garcia', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ferrer-Garcia', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gutiérrez-Maldonado', 'Affiliation': ""Department of Clinical Psychology and Psychobiology, Faculty of Psychology, University of Barcelona, Passeig de Vall d'Hebron, 175, 08035 Barcelona PC, Spain.""}]",Journal of clinical medicine,['10.3390/jcm9093018']
2609,32962313,"A Youth-Led, Social Marketing Intervention Run by Adolescents to Encourage Healthy Lifestyles among Younger School Peers (EYTO-Kids Project): A Protocol for Pilot Cluster Randomized Controlled Trial (Spain).","INTRODUCTION


The EYTO-kids (European Youth Tackling Obesity in Adolescents and Children) study aims to increase fruit and/or vegetable consumption and physical activity, decrease sedentary lifestyles, and reduce the intake of sugary drinks and fast food using an innovative methodology based on social marketing and youth involvement.
METHODS


This study is a pilot school-based cluster randomized controlled 10-month intervention spanning two academic years (2015-2016 and 2016-2017), with eight primary schools and three high schools randomized into and designated the control group and eight primary schools and four high schools designated the intervention group in Reus, Spain. At least 301 younger school peers per group should be included. At the intervention high schools, the adolescent creators (ACs) receive an initial 16-h training session. In total, 26-32 high school ACs (12-14 years) from the four high schools will design and implement four health-promotion activities (1 h/each) for their younger (8-10 years), primary school peers. The control group will not receive any intervention. The outcomes (fruit, vegetable, fast food and sugary drink consumption; physical activity; and sedentary behaviors) of the control and intervention groups will be measured pre- and post-intervention.
CONCLUSION


This study describes a protocol for pilot, peer-led, social marketing and youth-involved intervention, where adolescents design and implement activities for their younger peers to promote healthy lifestyles.",2017,"INTRODUCTION


The EYTO-kids (European Youth Tackling Obesity in Adolescents and Children) study aims to increase fruit and/or vegetable consumption and physical activity, decrease sedentary lifestyles, and reduce the intake of sugary drinks and fast food using an innovative methodology based on social marketing and youth involvement.
","['In total, 26-32 high school ACs (12-14 years) from the four high schools will design and implement four health-promotion activities (1 h/each) for their younger (8-10 years), primary school peers', 'Younger School Peers (EYTO-Kids Project', 'pilot school-based cluster randomized controlled 10-month intervention spanning two academic years (2015-2016 and 2016-2017), with eight primary schools and three high schools randomized into and designated the control group and eight primary schools and four high schools designated the intervention group in Reus, Spain', '301 younger school peers per group should be included', 'kids (European Youth Tackling Obesity in Adolescents and Children']",[],"['outcomes (fruit, vegetable, fast food and sugary drink consumption; physical activity; and sedentary behaviors']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]",,0.0313091,"INTRODUCTION


The EYTO-kids (European Youth Tackling Obesity in Adolescents and Children) study aims to increase fruit and/or vegetable consumption and physical activity, decrease sedentary lifestyles, and reduce the intake of sugary drinks and fast food using an innovative methodology based on social marketing and youth involvement.
","[{'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Tarro', 'Affiliation': 'Health Education and Promotion, Functional Nutrition, Oxidation and Cardiovascular Diseases Group (NFOC-Salut), Facultat de Medicina i Ciències de la Salut, Universitat Rovira i Virgili, C/Sant Llorenç 21, 43204 Reus, Spain.'}, {'ForeName': 'Magaly', 'Initials': 'M', 'LastName': 'Aceves-Martins', 'Affiliation': 'Health Education and Promotion, Functional Nutrition, Oxidation and Cardiovascular Diseases Group (NFOC-Salut), Facultat de Medicina i Ciències de la Salut, Universitat Rovira i Virgili, C/Sant Llorenç 21, 43204 Reus, Spain.'}, {'ForeName': 'Ignasi', 'Initials': 'I', 'LastName': 'Papell-Garcia', 'Affiliation': 'Eurecat Reus: Technological Centre of Nutrition and Health (CTNS) -TECNIO-URV-CEICS, Av. Universitat 1, 43204 Reus, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Arola', 'Affiliation': 'Eurecat Reus: Technological Centre of Nutrition and Health (CTNS) -TECNIO-URV-CEICS, Av. Universitat 1, 43204 Reus, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Giralt', 'Affiliation': 'Health Education and Promotion, Functional Nutrition, Oxidation and Cardiovascular Diseases Group (NFOC-Salut), Facultat de Medicina i Ciències de la Salut, Universitat Rovira i Virgili, C/Sant Llorenç 21, 43204 Reus, Spain.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Llauradó', 'Affiliation': 'Health Education and Promotion, Functional Nutrition, Oxidation and Cardiovascular Diseases Group (NFOC-Salut), Facultat de Medicina i Ciències de la Salut, Universitat Rovira i Virgili, C/Sant Llorenç 21, 43204 Reus, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solà', 'Affiliation': 'Health Education and Promotion, Functional Nutrition, Oxidation and Cardiovascular Diseases Group (NFOC-Salut), Facultat de Medicina i Ciències de la Salut, Universitat Rovira i Virgili, C/Sant Llorenç 21, 43204 Reus, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph14080923']
2610,32962461,The role of a neonatal hypothermia alert device in promoting weight gain in LBW infants.,"BACKGROUND


Neonatal hypothermia is a significant risk factor for preterm and low birth weight (LBW) newborns, especially in India. Kangaroo Mother Care (KMC) is one recommended method of thermal control. A wearable device, TempWatch, has been developed to monitor for and detect hypothermia and to promote KMC for preterm and LBW infants.
PURPOSE


This randomized controlled trial was designed to evaluate TempWatch's impact on weight gain, amount of KMC received, and length of hospital stay for LBW infants as compared to standard care.
METHODS


Otherwise healthy LBW infants (with birthweights 1500-2300 g) admitted to a KMC ward of a government hospital in New Delhi, India were randomly allocated to a TempWatch group or a control group and wore the device until their time of discharge. 50 infants were enrolled in each group. All participants received standard-of-care temperature monitoring, and those in the control group were monitored using the hand-touch method. Each group also received sixth-hourly temperature monitoring. Infants' daily weight and the number of hypothermia episodes they experienced per day were recorded, and mothers of infants in both groups completed daily KMC diaries.
RESULTS


The TempWatch group experienced statistically significant weight gain as compared to the control group (0.06 vs. 0.02 kg,  p  = .024). There were no statistically significant differences between the groups in the number of hypothermia events detected, the amount of KMC received.
CONCLUSION


TempWatch promotes statistically significant weight gain for LBW infants as compared to standard care.",2020,"There were no statistically significant differences between the groups in the number of hypothermia events detected, the amount of KMC received.
","['LBW infants', 'Otherwise healthy LBW infants (with birthweights 1500-2300\u2009g) admitted to a KMC ward of a government hospital in New Delhi', '50 infants were enrolled in each group']","['Kangaroo Mother Care (KMC', 'neonatal hypothermia alert device']","['number of hypothermia events', 'weight gain, amount of KMC received, and length of hospital stay', ""Infants' daily weight and the number of hypothermia episodes"", 'weight gain']","[{'cui': 'C0021288', 'cui_str': 'Low birth weight infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0919592', 'cui_str': 'Hypothermia neonatal'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",50.0,0.0646981,"There were no statistically significant differences between the groups in the number of hypothermia events detected, the amount of KMC received.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Azad', 'Affiliation': 'Department of Pediatrics, Swami Dayanand Hospital, New Delhi, India.'}, {'ForeName': 'Surender Singh', 'Initials': 'SS', 'LastName': 'Bisht', 'Affiliation': 'Department of Pediatrics, Swami Dayanand Hospital, New Delhi, India.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Tyagi', 'Affiliation': 'Department of Pediatrics, Swami Dayanand Hospital, New Delhi, India.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Jaipal', 'Affiliation': 'Department of Pediatrics, Swami Dayanand Hospital, New Delhi, India.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2020.1814244']
2611,32962477,Glucagon-like peptide-1 receptor agonist liraglutide therapy for psoriasis patients with type 2 diabetes: a randomized-controlled trial.,"OBJECTIVE


There were some clinical studies on GLP-1R agonist liraglutide therapy for psoriasis patients with type 2 diabetes, but there is a lack of randomized controlled trials and the mechanism of which remains unclear.
METHOD


A total of 25 psoriasis patients with type 2 diabetes were randomized 1: 1 divided into the control group ( n  = 13) or liraglutide group ( n  = 12) for 12 weeks. We determined the PASI, the DLQI, histopathology of psoriasis skin, and the expression of IL-17, IL-23, and TNF-α in the psoriasis skin.
RESULTS


After 12 weeks of treatment, the mean DLQI of the treatment group decreased from 22.00 ± 5.85 to 3.82 ± 3.60 ( p  < .05). Compared to week 12, the change in the baseline value of PASI and DLQI in the treatment group showed a significant difference compared with the control group ( p  < .05). The pathological changes of psoriasis skin and the expression of IL-17, IL-23, TNF-α in the psoriasis skin were improved in the treatment group. No serious adverse events occurred.
CONCLUSION


The skin lesions in psoriasis patients with type 2 diabetes were significantly improved after treatment with liraglutide, which may be related to the inhibition of the expression of inflammatory factors such as IL-23, IL-17, and TNF-α.",2020,"The pathological changes of psoriasis skin and the expression of IL-17, IL-23, TNF-α in the psoriasis skin were improved in the treatment group.","['25 psoriasis patients with type 2 diabetes', 'psoriasis patients with type 2 diabetes']","['liraglutide', 'GLP-1R agonist liraglutide therapy', 'Glucagon-like peptide-1 receptor agonist liraglutide therapy']","['mean DLQI', 'pathological changes of psoriasis skin and the expression of IL-17, IL-23, TNF-α in the psoriasis skin', 'baseline value of PASI and DLQI', 'skin lesions']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}]",25.0,0.0251982,"The pathological changes of psoriasis skin and the expression of IL-17, IL-23, TNF-α in the psoriasis skin were improved in the treatment group.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Yunjie', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Hongjiang', 'Initials': 'H', 'LastName': 'Ye', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Xiaoqiong', 'Initials': 'X', 'LastName': 'He', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Shengping', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Xaingqi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Zhulin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fujian, China.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1826392']
2612,32962480,Efficacy of Biocage in treating single-segment lumbar degenerative disease in patients with high risk of non-fusion: a prospective controlled study with at least 2 years' follow-up.,"OBJECTIVE


To evaluate the clinical efficacy of an allogeneic bone cage (Biocage; Beijing Datsing Bio-Tech Co., Ltd., Beijing, China) for treatment of single-segment lumbar degenerative disease in patients with a high risk of non-fusion.
METHODS


From January 2013 to December 2016, 67 patients who underwent lumbar fusion were divided into the Biocage group (n = 33) and polyether ether ketone (PEEK) group (n = 34). The patients were followed up for 24 to 48 months. The mean intervertebral height of the fusion level, fusion rate, height of the intervertebral foramen, visual analog scale score, and Oswestry disability index were compared.
RESULTS


The PEEK group had a lower fusion rate than the Biocage group (88.24% vs. 90.91%), although the difference was not statistically significant. During follow-up, the height of the intervertebral space was similar between the Biocage and PEEK groups (12.88 ± 0.45 and 12.84 ± 1.01 mm, respectively). The height of the intervertebral foramen was larger in the Biocage than PEEK group (20.67 ± 1.34 vs. 20.00 ± 2.05 mm). Good clinical efficacy was achieved in both groups.
CONCLUSION


The Biocage is efficient and safe for treatment of single-segment lumbar degenerative disease in patients with a high risk of non-fusion.",2020,"During follow-up, the height of the intervertebral space was similar between the Biocage and PEEK groups (12.88 ± 0.45 and 12.84 ± 1.01 mm, respectively).","['patients with high risk of non-fusion', 'patients with a high risk of non-fusion.\nMETHODS\n\n\nFrom January 2013 to December 2016, 67 patients who underwent lumbar fusion', 'patients with a high risk of non-fusion']","['polyether ether ketone (PEEK', 'Biocage', 'allogeneic bone cage (Biocage']","['height of the intervertebral space', 'height of the intervertebral foramen', 'mean intervertebral height of the fusion level, fusion rate, height of the intervertebral foramen, visual analog scale score, and Oswestry disability index', 'lower fusion rate', 'Good clinical efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}]","[{'cui': 'C0014994', 'cui_str': 'ethyl ether'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0337189', 'cui_str': 'Cage'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0223088', 'cui_str': 'Structure of intervertebral space'}, {'cui': 'C0223085', 'cui_str': 'Structure of intervertebral foramen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442106', 'cui_str': 'Intervertebral'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",,0.0203965,"During follow-up, the height of the intervertebral space was similar between the Biocage and PEEK groups (12.88 ± 0.45 and 12.84 ± 1.01 mm, respectively).","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'National & Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, The First Affiliated Hospital to Army Medical University (Southwest Hospital), Chongqing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Tian-Yong', 'Initials': 'TY', 'LastName': 'Hou', 'Affiliation': 'National & Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, The First Affiliated Hospital to Army Medical University (Southwest Hospital), Chongqing, China.'}, {'ForeName': 'Ze-Hua', 'Initials': 'ZH', 'LastName': 'Zhang', 'Affiliation': 'National & Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, The First Affiliated Hospital to Army Medical University (Southwest Hospital), Chongqing, China.'}, {'ForeName': 'Jun-Chao', 'Initials': 'JC', 'LastName': 'Xing', 'Affiliation': 'National & Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, The First Affiliated Hospital to Army Medical University (Southwest Hospital), Chongqing, China.'}, {'ForeName': 'Hong-Wei', 'Initials': 'HW', 'LastName': 'Lu', 'Affiliation': 'National & Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, The First Affiliated Hospital to Army Medical University (Southwest Hospital), Chongqing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'National & Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, The First Affiliated Hospital to Army Medical University (Southwest Hospital), Chongqing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'National & Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, The First Affiliated Hospital to Army Medical University (Southwest Hospital), Chongqing, China.'}, {'ForeName': 'Jian-Zhong', 'Initials': 'JZ', 'LastName': 'Xu', 'Affiliation': 'National & Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, The First Affiliated Hospital to Army Medical University (Southwest Hospital), Chongqing, China.'}, {'ForeName': 'Wen-Jie', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': 'National & Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, The First Affiliated Hospital to Army Medical University (Southwest Hospital), Chongqing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': 'National & Regional Engineering Laboratory of Tissue Engineering, Department of Orthopedics, The First Affiliated Hospital to Army Medical University (Southwest Hospital), Chongqing, China.'}]",The Journal of international medical research,['10.1177/0300060520945500']
2613,32962487,Ranibizumab plus fufang xueshuantong capsule versus ranibizumab alone for exudative age-related macular degeneration.,"OBJECTIVE


To compare the efficacy of ranibizumab plus fufang xueshuantong capsule (cFXST) with the efficacy of ranibizumab alone in treatment of exudative age-related macular degeneration.
METHODS


This prospective, randomized, controlled, pilot study included 38 eyes from 38 patients with exudative age-related macular degeneration (AMD) that were randomly allocated into two cohorts of 19 eyes each: ranibizumab (C r ) and ranibizumab plus cFXST (C fr ). All patients received three monthly injections of ranibizumab. Patients in C fr  also received daily oral supplementation of cFXST. Best corrected visual acuity (BCVA) and thickness of the choroidal neovascularization-pigment epithelial detachment (CNV-PED) complex (measured by optical coherence tomography) were recorded at baseline and at 1 and 3 months after the first intravitreal injection of ranibizumab.
RESULTS


In the C fr , the CNV-PED complex thickness was reduced by 31.7% and 36.1% at 1 and 3 months, respectively; these reductions were significantly greater than the 19.7% and 24.2% reductions in the C r . BCVA improvement was significantly greater in the C fr  than in the C r  after 3 months; the proportion of patients with functional response was also greater in the C fr  than in the C r  (16/16 vs. 8/17).
CONCLUSION


Oral cFXST increases the efficacy of short-term ranibizumab treatment for exudative AMD.",2020,"BCVA improvement was significantly greater in the C fr  than in the C r  after 3 months; the proportion of patients with functional response was also greater in the C fr  than in the C r  (16/16 vs. 8/17).
","['38 eyes from 38 patients with exudative age-related macular degeneration (AMD', 'exudative age-related macular degeneration', 'exudative AMD']","['ranibizumab (C r ) and ranibizumab plus cFXST (C fr ', 'Oral cFXST', 'ranibizumab plus fufang xueshuantong capsule (cFXST', 'Ranibizumab plus fufang xueshuantong capsule versus ranibizumab alone', 'daily oral supplementation of cFXST', 'ranibizumab alone', 'ranibizumab']","['BCVA improvement', 'Best corrected visual acuity (BCVA) and thickness of the choroidal neovascularization-pigment epithelial detachment (CNV-PED) complex', 'CNV-PED complex thickness']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1956628', 'cui_str': 'Panax notoginseng extract'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0339546', 'cui_str': 'Retinal pigment epithelial detachment'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]",38.0,0.072237,"BCVA improvement was significantly greater in the C fr  than in the C r  after 3 months; the proportion of patients with functional response was also greater in the C fr  than in the C r  (16/16 vs. 8/17).
","[{'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Pan', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jun-Long', 'Initials': 'JL', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yuan-Lu', 'Initials': 'YL', 'LastName': 'Shuai', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Zi-Zhong', 'Initials': 'ZZ', 'LastName': 'Hu', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yu-Zhi', 'Initials': 'YZ', 'LastName': 'Ding', 'Affiliation': 'Department of Ophthalmology, Zhongda Hospital Southeast University, Nanjing, China.'}, {'ForeName': 'Qing-Huai', 'Initials': 'QH', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}]",The Journal of international medical research,['10.1177/0300060520931618']
2614,32962509,Non-immersive 3D virtual stimulus alter the time production task performance and increase the EEG theta power in dorsolateral prefrontal cortex.,"Aim : The study investigated the cortical activity changes and time production task performance induced by changes in motion speed of a non-immersive 3D virtual stimulus.  Material and Methods : Twenty-one individuals were participated in the crossover study with the visual-time reproduction task under three-speed conditions: original, slow and fast virtual stimulus. In addition, the electroencephalographic analysis of the theta band power in the dorsolateral prefrontal cortex was done simultaneously with time production task execution.  Results : The results demonstrated that in the slow speed condition, there is an increase in the error in the time production task after virtual reality (p < 0.05). There is also increased EEG theta power in the right dorsolateral prefrontal cortex in all speed conditions (p < 0.05).  Conclusions : We propose that the modulations of speed of virtual stimulus may underlie the accumulation of temporal pulses, which could be responsible for changes in the performance of the production task of the time intervals and a substantial increase in right dorsolateral prefrontal cortex activity related to attention and memory, acting in cognitive domains of supraseconds.",2020,There is also increased EEG theta power in the right dorsolateral prefrontal cortex in all speed conditions (p < 0.05).  ,"['Twenty-one individuals were participated in the crossover study with the visual-time reproduction task under three-speed conditions: original, slow and fast virtual stimulus']",['Material and Methods '],"['cortical activity changes and time production task performance', 'time production task', 'EEG theta power', 'time production task performance']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",21.0,0.0239566,There is also increased EEG theta power in the right dorsolateral prefrontal cortex in all speed conditions (p < 0.05).  ,"[{'ForeName': 'Diandra Caroline Martins E', 'Initials': 'DCME', 'LastName': 'Silva', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Marinho', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}, {'ForeName': 'Silmar', 'Initials': 'S', 'LastName': 'Teixeira', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Teles', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Marques', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Escórcio', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}, {'ForeName': 'Thayaná', 'Initials': 'T', 'LastName': 'Fernandes', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'Freitas', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}, {'ForeName': 'Monara', 'Initials': 'M', 'LastName': 'Nunes', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Ayres', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Ayres', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}, {'ForeName': 'Juliana Bittencourt', 'Initials': 'JB', 'LastName': 'Marques', 'Affiliation': 'Laboratory of neurophysiology and neuropsychology of attention, Veiga de Almeida University, Cabo Frio, 28909-000, Brazil.'}, {'ForeName': 'Maurício', 'Initials': 'M', 'LastName': 'Cagy', 'Affiliation': 'Masters and PhD Program in Biomedical Engineering, Federal University of Rio de Janeiro, Rio de Janeiro, 21941-450, Brazil.'}, {'ForeName': 'Daya S', 'Initials': 'DS', 'LastName': 'Gupta', 'Affiliation': 'Department of Biology, Camden County College, Blackwood, NJ, USA.'}, {'ForeName': 'Victor Hugo', 'Initials': 'VH', 'LastName': 'Bastos', 'Affiliation': 'Brain Mapping and Functionality, Laboratory, Federal University of Delta do Parnaíba, Parnaíba, 64202-020, Brazil.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1826945']
2615,32962523,Feasibility and effects of high-intensity interval training in older adults living with HIV.,"Adults with HIV on therapy can live a normal lifespan but exhibit advanced ageing which includes reduced cardiorespiratory fitness. Our objective was to determine the feasibility and effects of high-intensity interval training (HIIT) combined with resistance training (RT) in older adults with HIV. We conducted a cross-over pilot study within a randomized exercise trial in sedentary adults with HIV ≥50 years of age. First, participants were randomized to 4 months of continuous high-intensity aerobic exercise (AEX) and RT 3x/week or standard of care control. Then, the control group completed 4 months of HIIT + RT (3x/week). Among the 32 individuals enrolled, 26 eligible participants were randomized. Most participants were African American (63%) and male (95%) with a mean (SD) age of 61.5 (6.7) years and VO 2 peak of 24.5 (4.9) ml/kg/min. Attendance and adherence to both exercise training interventions were high. The clinically significant increases in VO 2 peak (ml/kg/min) after HIIT (3.09 ±1.04, p=0.02) and AEX (2.09 ±0.72, p=0.01) represented improvements of 17.1% and 7.7%, respectively. Both groups had improvements in exercise endurance (time on the treadmill) and strength (all p< 0.01). This pilot study supports HIIT as an efficient means to deliver high-intensity AEX to improve cardiorespiratory fitness toward the goal of attenuating the accelerated ageing process in adults with HIV.",2020,Both groups had improvements in exercise endurance (time on the treadmill) and strength (all p< 0.01).,"['older adults living with HIV', '32 individuals enrolled, 26 eligible participants were randomized', 'Most participants were African American (63%) and male (95%) with a mean (SD) age of 61.5 (6.7) years and VO 2 peak of 24.5 (4.9) ml/kg/min', 'older adults with HIV', 'adults with HIV', 'sedentary adults with HIV ≥50 years of age']","['exercise training interventions', 'continuous high-intensity aerobic exercise (AEX) and RT 3x/week or standard of care control', 'high-intensity interval training (HIIT) combined with resistance training (RT', 'high-intensity interval training', 'HIIT + RT']","['exercise endurance (time on the treadmill) and strength', 'VO 2 peak']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",26.0,0.159362,Both groups had improvements in exercise endurance (time on the treadmill) and strength (all p< 0.01).,"[{'ForeName': 'Brandon C', 'Initials': 'BC', 'LastName': 'Briggs', 'Affiliation': 'Geriatrics and Extended Care, Salem Veterans Affairs Medical Center , Salem, VA, USA.'}, {'ForeName': 'Alice S', 'Initials': 'AS', 'LastName': 'Ryan', 'Affiliation': 'Baltimore Geriatric Research, Education, and Clinical Center (GRECC), The Veterans Affairs Maryland Health Care System , Baltimore, MD, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'Baltimore Geriatric Research, Education, and Clinical Center (GRECC), The Veterans Affairs Maryland Health Care System , Baltimore, MD, USA.'}, {'ForeName': 'Krisann K', 'Initials': 'KK', 'LastName': 'Oursler', 'Affiliation': 'Geriatrics and Extended Care, Salem Veterans Affairs Medical Center , Salem, VA, USA.'}]",Journal of sports sciences,['10.1080/02640414.2020.1818949']
2616,32962531,Old and Depressed? What We Think About Ending Their Suffering-Attitudes Toward Euthanasia for Elderly Suffering From Physical Versus Mental Illness.,"This study aims to extend our knowledge regarding attitudes toward euthanasia. Specifically, the effect of patient's age and illness type. 123 participants were randomly assigned to 1 of 4 groups completed the Assessing Right to Die Attitudes (ARDA) questionnaire after reading a patients age (79 vs. 29 year old) and illness type (cancer vs. depression) description. Findings revealed more positive attitudes toward euthanasia when the patient was physically ill, as opposed to mentally ill. Participants' attitude towards euthanasia was more positive when the patient was elderly. Illness type as a function of the patient's age did not significantly influence attitudes towards euthanasia. The results of the current study reinforce the individual influence of illness type and of patient age on attitudes toward euthanasia, and suggest additional avenues for further research regarding their combined influence.",2020,Illness type as a function of the patient's age did not significantly influence attitudes towards euthanasia.,"['after reading a patients age (79 vs. 29\u2009year old) and illness type (cancer vs. depression) description', 'Suffering-Attitudes', 'Elderly Suffering From Physical Versus Mental Illness', '123 participants']",['Assessing Right to Die Attitudes (ARDA) questionnaire'],['positive attitudes toward euthanasia'],"[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0035617', 'cui_str': 'Right to Die'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0015187', 'cui_str': 'Euthanasia'}]",123.0,0.0338934,Illness type as a function of the patient's age did not significantly influence attitudes towards euthanasia.,"[{'ForeName': 'Shir', 'Initials': 'S', 'LastName': 'Moshe', 'Affiliation': 'Academic College of Tel Aviv-Yaffo, Yaffo, Israel.'}, {'ForeName': 'Avital', 'Initials': 'A', 'LastName': 'Gershfeld-Litvin', 'Affiliation': 'Academic College of Tel Aviv-Yaffo, Yaffo, Israel.'}]",Omega,['10.1177/0030222820961241']
2617,32962536,Use of the color Doppler twinkle artifact for teaching ultrasound guided peripheral vascular access.,"BACKGROUND


The optimal method for teaching ultrasound guided peripheral IV (USGPIV) insertion is unknown. Poor needle tip visualization has been cited for USGPIV failure. Twinkle artifact (TA), visualized with color Doppler, is used in other clinical settings. Our objective was to investigate whether teaching students USGPIV placement utilizing TA would enhance needle tip visualization and improve first pass success.
METHODS


This was a prospective, randomized study of premedical and preclinical medical students without prior USGPIV experience. Students were given a standardized didactic session on USGPIV placement before being randomized and separated to learn and practice USGPIV with or without TA (control). The students were given 5 min to perform USGPIV on phantom models. The primary outcome was the rate of first pass success. Secondary outcomes included total time to cannulation, rate of posterior venous wall puncture, and total number of attempts.
RESULTS


Rates of first pass success were similar in both the TA (82%) and control groups (57%),  p  = 0.095. There was a difference in the mean time to cannulation. The TA group achieved success at 50.76 s (SD 26.93) while the control group achieved success at 85.30 s (SD 65.47),  p  = 0.048.
CONCLUSION


In this study of utilizing TA to aid in USGPIV placement, students were able to achieve successful cannulation in a shorter amount of time. There was no significant difference in first pass success. Future studies should utilize a larger sample size and evaluate the utility of TA when placing USGPIV on patients.",2020,"RESULTS


Rates of first pass success were similar in both the TA (82%) and control groups (57%),  p  = 0.095.",['premedical and preclinical medical students without prior USGPIV experience'],"['Twinkle artifact (TA), visualized with color Doppler', 'standardized didactic session on USGPIV placement before being randomized and separated to learn and practice USGPIV with or without TA (control']","['mean time to cannulation', 'Rates of first pass success', 'total time to cannulation, rate of posterior venous wall puncture, and total number of attempts', 'rate of first pass success']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0522507', 'cui_str': 'With color'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0226509', 'cui_str': 'Structure of wall of vein'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0580583,"RESULTS


Rates of first pass success were similar in both the TA (82%) and control groups (57%),  p  = 0.095.","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gardecki', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Liam P', 'Initials': 'LP', 'LastName': 'Hughes', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Saami', 'Initials': 'S', 'LastName': 'Zakaria', 'Affiliation': 'Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Resa E', 'Initials': 'RE', 'LastName': 'Lewiss', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Goodsell', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Risler', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Shughart', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Norton', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Au', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}]",The journal of vascular access,['10.1177/1129729820959907']
2618,32962657,Effects of propofol and sevoflurane on hepatic blood flow: a randomized controlled trial.,"BACKGROUND


Maintaining adequate perioperative hepatic blood flow (HBF) supply is essential for preservation of postoperative normal liver function. Propofol and sevoflurane affect arterial and portal HBF. Previous studies have suggested that propofol increases total HBF, primarily by increasing portal HBF, while sevoflurane has only minimal effect on total HBF. Primary objective was to compare the effect of propofol (group P) and sevoflurane (group S) on arterial, portal and total HBF and on the caval and portal vein pressure during major abdominal surgery. The study was performed in patients undergoing pancreaticoduodenectomy because - in contrast to hepatic surgical procedures - this is a standardized surgical procedure without potential anticipated severe hemodynamic disturbances, and it allows direct access to the hepatic blood vessels.
METHODS


Patients were randomized according to the type of anesthetic drug used. For both groups, Bispectral Index (BIS) monitoring was used to monitor depth of anesthesia. All patients received goal-directed hemodynamic therapy (GDHT) guided by the transpulmonary thermodilution technique. Hemodynamic data were measured, recorded and guided by Pulsioflex™. Arterial, portal and total HBF were measured directly, using ultrasound transit time flow measurements (TTFM) and were related to hemodynamic variables.
RESULTS


Eighteen patients were included. There was no significant difference between groups in arterial, portal and total HBF. As a result of the GDHT, pre-set hemodynamic targets were obtained in both groups, but MAP was significantly lower in group S (p = 0.01). In order to obtain these pre-set hemodynamic targets, group S necessitated a significantly higher need for vasopressor support (p < 0.01).
CONCLUSION


Hepatic blood flow was similar under a propofol-based and a sevoflurane-based anesthetic regimen. Related to the application of GDHT, pre-set hemodynamic goals were maintained in both groups, but sevoflurane-anaesthetized patients had a significantly higher need for vasopressor support.
TRIAL REGISTRATION


Study protocol number is AGO/2017/002 - EC/2017/0164. EudraCT number is 2017-000071-90. Clin.trail.gov, NCT03772106 , Registered 4/12/2018, retrospective registered.",2020,"There was no significant difference between groups in arterial, portal and total HBF.","['Patients', 'patients undergoing pancreaticoduodenectomy because - in contrast to hepatic surgical procedures ', 'Eighteen patients were included', 'major abdominal surgery']","['propofol', 'Propofol and sevoflurane', 'propofol and sevoflurane', 'goal-directed hemodynamic therapy (GDHT) guided by the transpulmonary thermodilution technique', 'sevoflurane']","['Bispectral Index (BIS) monitoring', 'hepatic blood flow', 'total HBF', 'Hemodynamic data', 'arterial, portal and total HBF', 'ultrasound transit time flow measurements (TTFM', 'Arterial, portal and total HBF', 'arterial, portal and total HBF and on the caval and portal vein pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0441668', 'cui_str': 'Thermodilution technique'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032718', 'cui_str': 'Portal vein structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",18.0,0.0547106,"There was no significant difference between groups in arterial, portal and total HBF.","[{'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'van Limmen', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium. Jurgen.vanlimmen@ugent.be.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Wyffels', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Berrevoet', 'Affiliation': 'Department of General and Hepatic-pancreatico-biliary Surgery and Liver transplantation, Ghent University Hospital, Corneel Heymanslaan 10, Ghent, 9000, Belgium.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Vanlander', 'Affiliation': 'Department of General and Hepatic-pancreatico-biliary Surgery and Liver transplantation, Ghent University Hospital, Corneel Heymanslaan 10, Ghent, 9000, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Coeman', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wouters', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'De Hert', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'De Baerdemaeker', 'Affiliation': 'Department of Anaesthesiology and Perioperative Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000, Ghent, Belgium.'}]",BMC anesthesiology,['10.1186/s12871-020-01150-3']
2619,32962673,Assessment of the effect of platelet rich plasma on the healing of operated sacrococcygeal pilonidal sinus by lay-open technique: a randomized clinical trial.,"BACKGROUND


Sacrococcygeal pilonidal sinus disease (PSD) is an infection of the skin and subcutaneous tissue at the upper part of the natal cleft of the buttocks. Excision and healing by granulation ""lay-open"" method is still more preferable than other methods of midline closure or using flaps but the healing time is lengthy. The present study was performed to assess the healing promotion effect of platelet-rich plasma (PRP) on the pilonidal sinus wounds treated by the lay-open method.
METHODS


One hundred patients suffering from PSD were randomly divided into two groups, they were treated by the lay-open method, at General surgery department, Kafr El-Sheik University hospital, Egypt, during the period from December 2018 to December 2019. Group (A) was adopted the regular dressing postoperatively, while group (B) was treated with PRP injection into the wound at 4 and 12 postoperative days.
RESULTS


Accelerated rate of wound healing was detected in group (B) in day 10, with a significant difference detected in days 15, 20, 25 and 30 postoperative, with a mean time of complete healing 45 ± 2.6 days in group B, while it was 57 ± 2.4 days in group A with a p-value of 0.001 which indicates considerable effect in the treated group.
CONCLUSIONS


PRP injection is an effective new technique in accelerating the healing of pilonidal wound after surgery, with a significant decrease in post-operative pain, complications and an early return to work.
TRIAL REGISTRATION


retrospectively registered.
TRIAL REGISTRATION NUMBER


12/35/1016 issued on December 2018 from the Institution Review Board at Kafr El Sheikh University. ClinicalTrials.gov identifier: NCT04430413.",2020,"RESULTS


Accelerated rate of wound healing was detected in group (B) in day 10, with a significant difference detected in days 15, 20, 25 and 30 postoperative, with a mean time of complete healing 45 ± 2.6 days in group B, while it was 57 ± 2.4 days in group A with a p-value of 0.001 which indicates considerable effect in the treated group.
","['One hundred patients suffering from PSD were randomly divided into two groups, they were treated by the lay-open method, at General surgery department, Kafr El-Sheik University hospital, Egypt, during the period from December 2018 to December 2019']","['platelet-rich plasma (PRP', 'PRP injection', 'platelet rich plasma']",['rate of wound healing'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031925', 'cui_str': 'Pilonidal cyst'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0347984', 'cui_str': 'During'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",100.0,0.027822,"RESULTS


Accelerated rate of wound healing was detected in group (B) in day 10, with a significant difference detected in days 15, 20, 25 and 30 postoperative, with a mean time of complete healing 45 ± 2.6 days in group B, while it was 57 ± 2.4 days in group A with a p-value of 0.001 which indicates considerable effect in the treated group.
","[{'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Gohar', 'Affiliation': 'General Surgery Department, Kafr El Shiekh University Hospital, Kafr El Shiekh, Egypt. dr.mmmg.1990@gmail.com.'}, {'ForeName': 'Reda F', 'Initials': 'RF', 'LastName': 'Ali', 'Affiliation': 'General Surgery Department, Kafr El Shiekh University Hospital, Kafr El Shiekh, Egypt.'}, {'ForeName': 'Khaled A', 'Initials': 'KA', 'LastName': 'Ismail', 'Affiliation': 'General Surgery Department, Kafr El Shiekh University Hospital, Kafr El Shiekh, Egypt.'}, {'ForeName': 'Taha A', 'Initials': 'TA', 'LastName': 'Ismail', 'Affiliation': 'General Surgery Department, Kafr El Shiekh University Hospital, Kafr El Shiekh, Egypt.'}, {'ForeName': 'Nahla A', 'Initials': 'NA', 'LastName': 'Nosair', 'Affiliation': 'Clinical Pathology Department, Kafr El Shiekh University Hospital, Kafr El Shiekh, Egypt.'}]",BMC surgery,['10.1186/s12893-020-00865-x']
2620,32962674,A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol.,"BACKGROUND


Since the development of three-dimensional conformal radiotherapy and intensity-modulated radiotherapy (IMRT), no prospective study has investigated whether concurrent chemoradiotherapy (SIB-IMRT with 60 Gy) remains superior to radiotherapy (SIB-IMRT) alone for unresectable esophageal cancer (EC). Furthermore, the optimal therapeutic regimen for patients who cannot tolerate concurrent chemoradiotherapy is unclear. We recently completed a phase I/II radiation dose-escalation trial using simultaneous integrated boost (SIB), elective nodal irradiation, and concurrent chemotherapy for unresectable EC. We now intend to conduct a prospective, phase III, randomized study of SIB-IMRT with or without concurrent chemotherapy. We aim to find a safe, practical, and effective therapeutic regimen to replace the conventional segmentation (1.8-2.0 Gy) treatment mode (radiotherapy ± chemotherapy) for unresectable EC.
METHODS


This two-arm, open, randomized, multicenter, phase III trial will recruit esophageal squamous cell carcinoma patients (stage IIA-IVB [UICC 2002]; IVB only with metastasis to the supraclavicular or celiac lymph nodes). In all, 164 patients will be randomized using a 1:1 allocation ratio, and stratified by study site and disease stage, especially the extent of lymph node metastasis. Patients in the SIB arm will receive definitive SIB radiotherapy (95% planning target volume/planning gross tumor volume, 50.4 Gy/59.92 Gy/28 f, equivalent dose in 2-Gy fractions = 60.62 Gy). Patients in the SIB + concurrent chemotherapy arm will receive definitive SIB radiotherapy with weekly paclitaxel and a platinum-based drug (5-6 weeks). Four cycles of consolidated chemoradiotherapy will also be recommended. The primary objective is to compare the 1-year, 2-year, and 3-year overall survival of the SIB + chemotherapy group and SIB groups. Secondary objectives include progression-free survival, local recurrence-free rate, completion rate, and adverse events. Detailed radiotherapy protocol and quality-assurance procedures have been incorporated into this trial.
DISCUSSION


In unresectable, locally advanced EC, a safe and effective total radiotherapy dose and reasonable segmentation doses are required for the clinical application of SIB-IMRT + two-drug chemotherapy. Whether this protocol will replace the standard treatment regimen will be prospectively investigated. The effects of SIB-IMRT in patients with poor physical condition who cannot tolerate definitive chemoradiotherapy will also be investigated.
TRIAL REGISTRATION


clinicaltrials.gov ( NCT03308552 , November 1, 2017).",2020,"Patients in the SIB arm will receive definitive SIB radiotherapy (95% planning target volume/planning gross tumor volume, 50.4 Gy/59.92 Gy/28 f, equivalent dose in 2-Gy fractions = 60.62 Gy).","['164 patients', 'patients who cannot tolerate concurrent', 'patients with esophageal cancer', 'patients with poor physical condition who cannot tolerate definitive', 'esophageal squamous cell carcinoma patients (stage IIA-IVB [UICC 2002]; IVB only with metastasis to the supraclavicular or celiac lymph nodes']","['definitive SIB radiotherapy', 'chemoradiotherapy (SIB-IMRT with 60\u2009Gy', 'SIB-IMRT', 'SIB-IMRT with or without concurrent chemotherapy', 'chemoradiotherapy', 'definitive SIB radiotherapy with weekly paclitaxel and a platinum-based drug', 'radiotherapy (SIB-IMRT) alone', 'simultaneous integrated boost (SIB), elective nodal irradiation, and concurrent chemotherapy', 'conventional segmentation (1.8-2.0\u2009Gy) treatment mode (radiotherapy ± chemotherapy', 'consolidated chemoradiotherapy', 'simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy', 'dimensional conformal radiotherapy and intensity-modulated radiotherapy (IMRT']","['1-year, 2-year, and 3-year overall survival', 'progression-free survival, local recurrence-free rate, completion rate, and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0441768', 'cui_str': 'Stage 2A'}, {'cui': 'C0441914', 'cui_str': 'UICC'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0229766', 'cui_str': 'Celiac lymph node group'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",164.0,0.119858,"Patients in the SIB arm will receive definitive SIB radiotherapy (95% planning target volume/planning gross tumor volume, 50.4 Gy/59.92 Gy/28 f, equivalent dose in 2-Gy fractions = 60.62 Gy).","[{'ForeName': 'Lin-Rui', 'Initials': 'LR', 'LastName': 'Gao', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department 4th of Radiation Oncology, Anyang Cancer Hospital, Anyang, 455000, China.'}, {'ForeName': 'Yidian', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department 4th of Radiation Oncology, Anyang Cancer Hospital, Anyang, 455000, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Ni', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Chang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Zongmei', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Wenyang', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Bi', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Jianyang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Yirui', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Qinfu', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Jima', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Oncology, Affiliated Tengzhou Central People's Hospital of Jining Medical University, Jining Medical University, Tengzhou, 277599, China. lilingtz@163.com.""}, {'ForeName': 'Zefen', 'Initials': 'Z', 'LastName': 'Xiao', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. xiaozefen@sina.com.'}]",BMC cancer,['10.1186/s12885-020-07387-y']
2621,32962677,Testing a physical education-delivered autonomy supportive intervention to promote leisure-time physical activity in lower secondary school students: the PETALS trial.,"BACKGROUND


Inadequate physical activity in young people is associated with several physical and mental health concerns. Physical education (PE) is a potentially viable existing network for promoting physical activity in this population. However, little research has been conducted on whether PE teachers can influence students' engagement in leisure-time physical activity. The present study therefore examined the efficacy of an intervention aimed at increasing PE teachers' autonomy support on students' leisure-time physical activity (the PETALS trial). The intervention was guided by the trans-contextual model (TCM) explaining the processes by which PE teachers' provision of autonomy support during PE promotes students' motivation and engagement in physical activity in their leisure time.
METHODS


The study adopted a cluster-randomized, waitlist control intervention design with randomization by school. Participants were PE teachers (N = 29, 44.83%female; M age = 42.83, SD = 9.53 yrs) and their lower secondary school students (N = 502, 43.82%female; M age = 14.52, SD = 0.71 yrs). We measured TCM constructs, including perceived autonomy support, autonomous motivation in PE and leisure time, beliefs and intentions towards leisure-time physical activity, and physical activity behavior at baseline, post-intervention, and at one-, three-, and six-months. Study hypotheses were tested through a series of ANOVAs and structural equation models using post-intervention and one-month follow-up data.
RESULTS


We found no changes in TCM constructs or physical activity behavior in either group at post-intervention or at 1 month. Path analyses supported two propositions of the TCM as change variables: perceived autonomy support had a significant effect on autonomous motivation in PE and autonomous motivation in PE had a significant effect on autonomous motivation in leisure time. Although we found a direct effect of autonomous motivation in leisure time on physical activity, we did not find support for the third premise of the TCM that autonomous motivation in leisure time indirectly affects physical activity through beliefs and intentions.
CONCLUSIONS


Current findings did not support the efficacy of the PETALS intervention at changing physical activity behavior and TCM constructs. More research is required to determine whether the TCM predictive validity is supported when other model variables are manipulated through experimental and intervention studies.
TRIAL REGISTRATION


ISRCTN, ISRCTN39374060 . Registered 19 July 2018. Prospectively registered.",2020,We found no changes in TCM constructs or physical activity behavior in either group at post-intervention or at 1 month.,"['young people', 'lower secondary school students', 'Participants were PE teachers (N\u2009=\u200929, 44.83%female; M age\u2009=\u200942.83, SD\u2009=\u20099.53\u2009yrs) and their lower secondary school students (N\u2009=\u2009502, 43.82%female; M age\u2009=\u200914.52, SD\u2009=\u20090.71\u2009yrs']","['Physical education (PE', 'intervention was guided by the trans-contextual model (TCM', 'physical education-delivered autonomy supportive intervention']","['perceived autonomy support, autonomous motivation in PE and leisure time, beliefs and intentions towards leisure-time physical activity, and physical activity behavior', 'TCM constructs or physical activity behavior', 'autonomous motivation in PE and autonomous motivation', 'autonomous motivation in leisure time']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]",,0.0460103,We found no changes in TCM constructs or physical activity behavior in either group at post-intervention or at 1 month.,"[{'ForeName': 'Jekaterina', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Keskussairaalantie 4, 40600, Jyväskylä, Finland. schneiderjekaterina@gmail.com.'}, {'ForeName': 'Juho', 'Initials': 'J', 'LastName': 'Polet', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Keskussairaalantie 4, 40600, Jyväskylä, Finland.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hassandra', 'Affiliation': 'Department of Physical Education and Sport Science, University of Thessaly, Thessaly, Greece.'}, {'ForeName': 'Taru', 'Initials': 'T', 'LastName': 'Lintunen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Keskussairaalantie 4, 40600, Jyväskylä, Finland.'}, {'ForeName': 'Arto', 'Initials': 'A', 'LastName': 'Laukkanen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Keskussairaalantie 4, 40600, Jyväskylä, Finland.'}, {'ForeName': 'Nelli', 'Initials': 'N', 'LastName': 'Hankonen', 'Affiliation': 'Faculty of Social Sciences, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Mirja', 'Initials': 'M', 'LastName': 'Hirvensalo', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Keskussairaalantie 4, 40600, Jyväskylä, Finland.'}, {'ForeName': 'Tuija H', 'Initials': 'TH', 'LastName': 'Tammelin', 'Affiliation': 'LIKES Research Centre for Physical Activity and Health, Jyväskylä, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Törmäkangas', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Keskussairaalantie 4, 40600, Jyväskylä, Finland.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Hagger', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Keskussairaalantie 4, 40600, Jyväskylä, Finland.'}]",BMC public health,['10.1186/s12889-020-09518-3']
2622,32969699,Modeling longitudinal variation in affective response to exercise across a 16-week randomized control trial (RCT).,"Objective:  Consistent with the Science of Behavior Change (SOBC) experimental medicine approach, this early phase intervention development study examines the influence of an intervention strategy (exercise training) on a behavioral health outcome (exercise engagement) in the service of addressing a widespread threat to public health (physical inactivity).  Method:  Physically inactive participants ( N  = 201) were randomly assigned to one of four exercise training conditions fully crossed on intensity (moderate, vigorous) and duration (short, long). Training occurred over 16-weeks and in-bout assessments of affective response (valence) and ratings of perceived exertion (RPE) were collected during Weeks 1, 4, 8, and 16. Cardiorespiratory fitness (VO₂max) was assessed pre- or postintervention and exercise behavior was assessed at 6-months postintervention follow-up.  Results:  Across conditions, affective response to exercise did not change, on average, over 16-weeks. Conversely, RPE decreased slightly, on average, over time. Participants completing vigorous intensity exercise reported more negatively valenced affective response and higher RPE, on average, across weeks. Greater total exercise volume completed and greater change in VO₂max were associated with more negatively valenced affective response, on average. Baseline affective response scores were positively associated with exercise minutes at follow-up; however, average affective response scores across the intervention were not associated with minutes of exercise at follow-up.  Conclusions:  Affective response to exercise did not become more positive in valence over time as a function of training volume or change in VO₂max. Implications for translating these findings to inform future intervention development efforts are discussed. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Across conditions, affective response to exercise did not change, on average, over 16-weeks.",['Method:  Physically inactive participants ( N  = 201'],"['pre- or postintervention and exercise', 'intervention strategy (exercise training', 'exercise training conditions fully crossed on intensity (moderate, vigorous) and duration (short, long', 'vigorous intensity exercise']","['behavior', 'average affective response scores', 'affective response (valence) and ratings of perceived exertion (RPE', 'Greater total exercise volume', 'Baseline affective response scores', 'Cardiorespiratory fitness (VO₂max']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",201.0,0.0266697,"Across conditions, affective response to exercise did not change, on average, over 16-weeks.","[{'ForeName': 'Courtney J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychology and Neuroscience.'}, {'ForeName': 'Arielle S', 'Initials': 'AS', 'LastName': 'Gillman', 'Affiliation': 'Department of Psychology and Neuroscience.'}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Giordano', 'Affiliation': 'Department of Psychology and Neuroscience.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Department of Psychology and Neuroscience.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0001023']
2623,32969700,Balance of group sizes in randomized controlled trials published in American Psychological Association journals.,"OBJECTIVE


We evaluated whether sample size differences between arms of two-arm parallel group randomized controlled trials (RCTs) published in American Psychological Association (APA)-affiliated journals were consistently smaller than expected by chance with simple randomization.
METHOD


We searched PsycINFO for two-arm parallel group RCTs in APA-affiliated journals published January 2007 to September 2017 that used individual randomization (1:1 allocation ratio), reported the number of participants randomized, and did not describe employing restrictive randomization (e.g., blocking). We queried authors because randomization processes were often not described in articles, and we conducted a post hoc logistic regression analysis to attempt to identify factors associated with overly balanced groups.
RESULTS


We identified 203 eligible trials, but after the author query, it was determined that only 115 used simple randomization. Among those 115 trials, there was a significantly greater number of trials with smaller sample size differences between trial arms than would be expected by chance ( p  < .001); 89 of 115 (77%) had differences in trial arm sample sizes smaller than the 50% prediction interval threshold for these differences. Greater proportionate imbalance may be associated with larger trial size (odds ratio of 0.27, 95% CI [0.08, 0.94] for  N  > 200 vs.  N  ≤ 100); greater balance may be more common in higher impact journals, though this was not statistically significant.
CONCLUSIONS


Education is needed to ensure that randomization procedures are implemented as intended and fully and accurately reported and that balanced group sample sizes are not understood as an indicator of trial quality. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Greater proportionate imbalance may be associated with larger trial size (odds ratio of 0.27, 95% CI [0.08, 0.94] for  N  > 200 vs.  N  ≤ 100); greater balance may be more common in higher impact journals, though this was not statistically significant.
",[],[],[],[],[],[],,0.355944,"Greater proportionate imbalance may be associated with larger trial size (odds ratio of 0.27, 95% CI [0.08, 0.94] for  N  > 200 vs.  N  ≤ 100); greater balance may be more common in higher impact journals, though this was not statistically significant.
","[{'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Cañedo-Ayala', 'Affiliation': 'Lady Davis Institute for Medical Research.'}, {'ForeName': 'Danielle B', 'Initials': 'DB', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Levis', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chiovitti', 'Affiliation': 'Lady Davis Institute for Medical Research.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0001020']
2624,32969703,Effects of mindfulness training on posttraumatic stress symptoms from a community-based pilot clinical trial among survivors of intimate partner violence.,"Objective:  Exposure to intimate partner violence (IPV) is a significant public health issue associated with deleterious mental and medical health comorbidities, including posttraumatic stress disorder (PTSD). The hallmark symptoms of posttraumatic stress (PTS), even when not meeting the threshold for a diagnosis of PTSD, appear to be underpinned by poor self-regulation in multiple domains, including emotion, cognitive control, and physiological stress. Mindfulness-based stress reduction (MBSR) holds promise for treating PTS symptoms because evidence suggests it targets these domains. The current study was a pilot randomized clinical trial designed to examine changes in emotion regulation, attentional function, and physiological stress dysregulation among women IPV survivors with elevated PTS symptoms after participation in a group-based, 8-week MBSR program.  Method:  In total, 29 participants were randomized to receive MBSR ( n  = 19) or an active control ( n  = 10). Assessments were conducted at study entry, as well as 8 and 12 weeks later.  Results:  Between-group differences on primary outcomes were nonsignificant; however, when exploring within groups, statistically significant decreases in PTS symptoms, F(1.37, 16.53) = 5.19,  p  < .05, and emotion dysregulation, F(1.31, 14.46) = 9.36,  p  < .01, were observed after MBSR but not after the control intervention. Further, decreases in PTSD and emotion dysregulation were clinically significant for MBSR participants but not control participants.  Conclusions:  These preliminary data signal that MBSR may improve PTS symptoms and emotion regulation and suggest further study of the effectiveness of PTSD interventions guided by integrative models of MBSR mechanisms and psychophysiological models of stress regulation. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Further, decreases in PTSD and emotion dysregulation were clinically significant for MBSR participants but not control participants.  ","['women IPV survivors with elevated PTS symptoms after participation in a group-based, 8-week MBSR program', 'intimate partner violence (IPV', 'survivors of intimate partner violence', '29 participants']","['mindfulness training', 'MBSR', 'active control', 'Mindfulness-based stress reduction (MBSR']","['posttraumatic stress symptoms', 'PTSD and emotion dysregulation', 'PTS symptoms and emotion regulation', 'PTS symptoms', 'emotion regulation, attentional function, and physiological stress dysregulation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0151872', 'cui_str': 'Prothrombin time increased'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}]",29.0,0.0230815,"Further, decreases in PTSD and emotion dysregulation were clinically significant for MBSR participants but not control participants.  ","[{'ForeName': 'Autumn M', 'Initials': 'AM', 'LastName': 'Gallegos', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center.'}, {'ForeName': 'Kathi L', 'Initials': 'KL', 'LastName': 'Heffner', 'Affiliation': 'School of Nursing, University of Rochester Medical Center.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cerulli', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Luck', 'Affiliation': 'Department of Medical Humanities and Bioethics, University of Rochester Medical Center.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Department of Psychology, University of Rochester.'}, {'ForeName': 'Wilfred R', 'Initials': 'WR', 'LastName': 'Pigeon', 'Affiliation': 'Department of Psychiatry, University of Rochester Medical Center.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000975']
2625,32969708,Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor for ≥24 Weeks in People With CF and ≥1 F508del Allele: Interim Results of an Open-Label Phase Three Clinical Trial.,,2020,,['People With CF and ≥1 F508del Allele'],['Elexacaftor/Tezacaftor/Ivacaftor'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}]","[{'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}]",[],,0.0314959,,"[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Griese', 'Affiliation': 'Ludwig Maximilian University and German Center for Lung Research, Munich, Germany; matthias.griese@med.uni-muenchen.de.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Costa', 'Affiliation': 'University of Messina, 18980, Messina, Italy.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Linnemann', 'Affiliation': 'Emory University, 1371, Atlanta, Georgia, United States.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Mall', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'McKone', 'Affiliation': ""St. Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Polineni', 'Affiliation': 'University of Kansas Medical Center, Kansas City, Kansas, United States.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Quon', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Felix C', 'Initials': 'FC', 'LastName': 'Ringshausen', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Taylor-Cousar', 'Affiliation': 'National Jewish Health, Denver, Colorado, United States.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Withers', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, 9553, Exeter, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Moskowitz', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, United States.'}, {'ForeName': 'Cori L', 'Initials': 'CL', 'LastName': 'Daines', 'Affiliation': 'University of Arizona, Banner University Medical Center, Tucson, Arizona, United States.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202008-3176LE']
2626,32969833,An Internet-Based Intervention Augmented With a Diet and Physical Activity Consultation to Decrease the Risk of Dementia in At-Risk Adults in a Primary Care Setting: Pragmatic Randomized Controlled Trial.,"BACKGROUND


There is a need to develop interventions to reduce the risk of dementia in the community by addressing lifestyle factors and chronic diseases over the adult life course.
OBJECTIVE


This study aims to evaluate a multidomain dementia risk reduction intervention, Body Brain Life in General Practice (BBL-GP), targeting at-risk adults in primary care.
METHODS


A pragmatic, parallel, three-arm randomized trial involving 125 adults aged 18 years or older (86/125, 68.8% female) with a BMI of ≥25 kg/m 2  or a chronic health condition recruited from general practices was conducted. The arms included (1) BBL-GP, a web-based intervention augmented with an in-person diet and physical activity consultation; (2) a single clinician-led group, Lifestyle Modification Program (LMP); and (3) a web-based control. The primary outcome was the Australian National University Alzheimer Disease Risk Index Short Form (ANU-ADRI-SF).
RESULTS


Baseline assessments were conducted on 128 participants. A total of 125 participants were randomized to 3 groups (BBL-GP=42, LMP=41, and control=42). At immediate, week 18, week 36, and week 62 follow-ups, the completion rates were 43% (18/42), 57% (24/42), 48% (20/42), and 48% (20/42), respectively, for the BBL-GP group; 71% (29/41), 68% (28/41), 68% (28/41), and 51% (21/41), respectively, for the LMP group; and 62% (26/42), 69% (29/42), 60% (25/42), and 60% (25/42), respectively, for the control group. The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups. These comparisons were all significant at the 5% level for estimates adjusted for baseline differences (immediate: difference in means -3.86, 95% CI -6.81 to -0.90, P=.01; week 18: difference in means -4.05, 95% CI -6.81 to -1.28, P<.001; week 36: difference in means -4.99, 95% CI -8.04 to -1.94, P<.001; and week 62: difference in means -4.62, 95% CI -7.62 to -1.62, P<.001).
CONCLUSIONS


A web-based multidomain dementia risk reduction program augmented with allied health consultations administered within the general practice context can reduce dementia risk exposure for at least 15 months. This study was limited by a small sample size, and replication on a larger sample with longer follow-up will strengthen the results.
TRIAL REGISTRATION


Australian clinical trials registration number (ACTRN): 12616000868482; https://anzctr.org.au/ACTRN12616000868482.aspx.",2020,The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups.,"['125 participants', 'risk adults in primary care', '128 participants', '125 adults aged 18 years or older (86/125, 68.8% female) with a BMI of ≥25 kg/m 2  or a chronic health condition recruited from general practices was conducted']","['Internet-Based Intervention Augmented With a Diet and Physical Activity Consultation', 'multidomain dementia risk reduction intervention, Body Brain Life', 'BBL-GP, a web-based intervention augmented with an in-person diet and physical activity consultation; (2) a single clinician-led group, Lifestyle Modification Program (LMP); and (3) a web-based control']","['Risk of Dementia', 'ANU-ADRI-SF score', 'Australian National University Alzheimer Disease Risk Index Short Form (ANU-ADRI-SF', 'completion rates', 'dementia risk exposure']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",125.0,0.168262,The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups.,"[{'ForeName': 'Kaarin J', 'Initials': 'KJ', 'LastName': 'Anstey', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Cherbuin', 'Affiliation': 'Centre for Research on Ageing, Health and Wellbeing, Australian National University, Canberra, Australia.'}, {'ForeName': 'Sarang', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Wicking Dementia Resaerch & Education Centre, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'McMaster', 'Affiliation': 'Centre for Research on Ageing, Health and Wellbeing, Australian National University, Canberra, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': ""D'Este"", 'Affiliation': 'National Centre for Epidemiology and Public Health, Australian National University, Canberra, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lautenschlager', 'Affiliation': 'Academic Unit for Psychiatry of Old Age, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Rebok', 'Affiliation': 'Johns Hopkins Centre on Aging and Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McRae', 'Affiliation': 'Centre for Research on Ageing, Health and Wellbeing, Australian National University, Canberra, Australia.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Torres', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Cox', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Constance Dimity', 'Initials': 'CD', 'LastName': 'Pond', 'Affiliation': 'Department of General Practice, University of Newcastle, Newcastle, Australia.'}]",Journal of medical Internet research,['10.2196/19431']
2627,32969834,Virtual Reality Meditation Among Youth Experiencing Homelessness: Pilot Randomized Controlled Trial of Feasibility.,"BACKGROUND


Homelessness among youth is devastating, with high rates of substance use disorders and mental health comorbidity. Mindfulness-based interventions that include meditation and mindfulness skills training reduce stress and symptoms of anxiety or depression. However, engaging high-risk youth in interventions is challenging. Virtual reality is a more flexible platform for delivering meditation and may be appealing to youth.
OBJECTIVE


The study objectives were to evaluate the feasibility of delivering virtual reality meditation and of collecting outcome measures, including anxiety and physiologic stress.
METHODS


A sample of 30 youth experiencing homelessness was enrolled in the study. Youth were randomized to receive 10 minutes of one of three interventions: (1) virtual reality meditation, (2) audio meditation (through a web-based platform), or (3) virtual reality imagery of historical pictures and text. Subjects who consented to the study attended two research visits. The first visit collected survey measures of demographics, mental health, and substance use, and oriented subjects to the intervention platforms. The second visit (1-3 days later) delivered the intervention and collected pre and post outcome measures of anxiety and physiologic stress (salivary cortisol). Changes in anxiety and cortisol at the second visit were compared across groups using a linear regression model in which the primary analysis compared virtual reality meditation to audio meditation and secondary analyses compared virtual reality meditation to virtual reality imagery.
RESULTS


Anxiety scores decreased in all groups, with a larger reduction among the virtual reality meditation group (difference=10.8) compared to the web-based meditation or virtual reality images groups (difference=5.8 and 5.0, respectively). After controlling for baseline values, there were no significant group differences in changes in anxiety scores or cortisol levels. In comparing virtual reality meditation and audio meditation, the effect size for anxiety was moderate (Cohen d=0.58) while the effect size for cortisol was small (Cohen d=0.08).
CONCLUSIONS


Preliminary results suggest that virtual reality meditation has a moderate benefit for anxiety but not physiologic stress. Future research is needed to confirm these results in a larger sample and to investigate whether the effects are sustained or increase with repeated use of virtual reality mediation. Virtual reality meditation appears feasible to deliver among homeless youth and merits further study.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04004520; https://clinicaltrials.gov/ct2/show/NCT04004520.",2020,"RESULTS


Anxiety scores decreased in all groups, with a larger reduction among the virtual reality meditation group (difference=10.8) compared to the web-based meditation or virtual reality images groups (difference=5.8 and 5.0, respectively).","['Subjects who consented to the study attended two research visits', 'Youth Experiencing Homelessness', '30 youth experiencing homelessness was enrolled in the study', 'homeless youth']","['virtual reality meditation', 'virtual reality meditation to audio meditation and secondary analyses compared virtual reality meditation to virtual reality imagery', 'virtual reality meditation, (2) audio meditation (through a web-based platform), or (3) virtual reality imagery of historical pictures and text', 'Mindfulness-based interventions that include meditation and mindfulness skills training', 'Virtual Reality Meditation', 'Virtual reality meditation', 'virtual reality meditation and audio meditation']","['Anxiety scores', 'anxiety and physiologic stress', 'anxiety and physiologic stress (salivary cortisol', 'anxiety scores or cortisol levels', 'stress and symptoms of anxiety or depression']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0242663', 'cui_str': 'Homeless Children'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",30.0,0.0776992,"RESULTS


Anxiety scores decreased in all groups, with a larger reduction among the virtual reality meditation group (difference=10.8) compared to the web-based meditation or virtual reality images groups (difference=5.8 and 5.0, respectively).","[{'ForeName': 'Laura Johnson', 'Initials': 'LJ', 'LastName': 'Chavez', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH, United States.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kelleher', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH, United States.""}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Slesnick', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Holowacz', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Ellison', 'Initials': 'E', 'LastName': 'Luthy', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': 'College of Nursing, Columbus, OH, United States.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': 'College of Nursing, Columbus, OH, United States.'}]",JMIR mental health,['10.2196/18244']
2628,32962684,Promotion of mental health in young adults via mobile phone app: study protocol of the ECoWeB (emotional competence for well-being in Young adults) cohort multiple randomised trials.,"BACKGROUND


Promoting well-being and preventing poor mental health in young people is a major global priority. Building emotional competence (EC) skills via a mobile app may be an effective, scalable and acceptable way to do this. However, few large-scale controlled trials have examined the efficacy of mobile apps in promoting mental health in young people; none have tailored the app to individual profiles.
METHOD/DESIGN


The Emotional Competence for Well-Being in Young Adults cohort multiple randomised controlled trial (cmRCT) involves a longitudinal prospective cohort to examine well-being, mental health and EC in 16-22 year olds across 12 months. Within the cohort, eligible participants are entered to either the PREVENT trial (if selected EC scores at baseline within worst-performing quartile) or to the PROMOTE trial (if selected EC scores not within worst-performing quartile). In both trials, participants are randomised (i) to continue with usual practice, repeated assessments and a self-monitoring app; (ii) to additionally receive generic cognitive-behavioural therapy self-help in app; (iii) to additionally receive personalised EC self-help in app. In total, 2142 participants aged 16 to 22 years, with no current or past history of major depression, bipolar disorder or psychosis will be recruited across UK, Germany, Spain, and Belgium. Assessments take place at baseline (pre-randomisation), 1, 3 and 12 months post-randomisation. Primary endpoint and outcome for PREVENT is level of depression symptoms on the Patient Health Questionnaire-9 at 3 months; primary endpoint and outcome for PROMOTE is emotional well-being assessed on the Warwick-Edinburgh Mental Wellbeing Scale at 3 months. Depressive symptoms, anxiety, well-being, health-related quality of life, functioning and cost-effectiveness are secondary outcomes. Compliance, adverse events and potentially mediating variables will be carefully monitored.
CONCLUSIONS


The trial aims to provide a better understanding of the causal role of learning EC skills using interventions delivered via mobile phone apps with respect to promoting well-being and preventing poor mental health in young people. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective Mobile-health public health strategies for preventing poor mental health and promoting well-being.
TRIAL REGISTRATION


ClinicalTrials.gov ( www.clinicaltrials.org ). Number of identification: NCT04148508 November 2019.",2020,"Building emotional competence (EC) skills via a mobile app may be an effective, scalable and acceptable way to do this.","['young people', 'young adults', 'Young adults', '16-22\u2009year olds across 12\u2009months', '2142 participants aged 16 to 22\u2009years, with no current or past history of major depression, bipolar disorder or psychosis will be recruited across UK, Germany, Spain, and Belgium']","['ECoWeB (emotional competence', 'usual practice, repeated assessments and a self-monitoring app; (ii) to additionally receive generic cognitive-behavioural therapy self-help in app; (iii) to additionally receive personalised EC self-help in app']","['Emotional Competence', 'Compliance, adverse events', 'level of depression symptoms on the Patient Health Questionnaire-9 at 3\u2009months; primary endpoint and outcome for PROMOTE is emotional well-being assessed on the Warwick-Edinburgh Mental Wellbeing Scale', 'Depressive symptoms, anxiety, well-being, health-related quality of life, functioning and cost-effectiveness']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1444635', 'cui_str': 'Current or past'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0579049', 'cui_str': 'Generic cognitive behavioral therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",2142.0,0.265965,"Building emotional competence (EC) skills via a mobile app may be an effective, scalable and acceptable way to do this.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Newbold', 'Affiliation': 'Mood Disorders Centre, School of Psychology, Sir Henry Wellcome Building for Mood Disorders Research, University of Exeter, Exeter, EX4 4LN, UK.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Warren', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Burnett', 'Affiliation': 'Mood Disorders Centre, School of Psychology, Sir Henry Wellcome Building for Mood Disorders Research, University of Exeter, Exeter, EX4 4LN, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Aas', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, LMU, Munich, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'Universitat Jaume I, Castelló de la Plana, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Burkhardt', 'Affiliation': 'audEERING, Munich, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ehring', 'Affiliation': 'Department of Psychology, LMU Munich, Munich, Germany.'}, {'ForeName': 'J R J', 'Initials': 'JRJ', 'LastName': 'Fontaine', 'Affiliation': 'Department of Work, Organization and Society, Ghent University, Ghent, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Frost', 'Affiliation': 'Monsenso ApS, Copenhagen, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Garcia-Palacios', 'Affiliation': 'Universitat Jaume I, Castelló de la Plana, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Greimel', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, LMU, Munich, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hoessle', 'Affiliation': 'Department of Psychology, LMU Munich, Munich, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hovasapian', 'Affiliation': 'Department of Work, Organization and Society, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Vei', 'Initials': 'V', 'LastName': 'Huyghe', 'Affiliation': 'Department of Work, Organization and Society, Ghent University, Ghent, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lochner', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, LMU, Munich, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Molinari', 'Affiliation': 'CIBER Fisiopatología Obesidad y Nutrición (CIBERObn), Instituto Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Pekrun', 'Affiliation': 'Department of Psychology, University of Essex, UK, and Institute for Positive Psychology and Education, Australian Catholic University, Sydney, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Platt', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, LMU, Munich, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rosenkranz', 'Affiliation': 'Department of Psychology, LMU Munich, Munich, Germany.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Scherer', 'Affiliation': 'University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schlegel', 'Affiliation': 'University of Bern, Bern, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Schulte-Korne', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, LMU, Munich, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Suso', 'Affiliation': 'Universitat Jaume I, Castelló de la Plana, Spain.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Voigt', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, LMU, Munich, Germany.'}, {'ForeName': 'E R', 'Initials': 'ER', 'LastName': 'Watkins', 'Affiliation': 'Mood Disorders Centre, School of Psychology, Sir Henry Wellcome Building for Mood Disorders Research, University of Exeter, Exeter, EX4 4LN, UK. e.r.watkins@exeter.ac.uk.'}]",BMC psychiatry,['10.1186/s12888-020-02857-w']
2629,32962709,"Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study.","BACKGROUND


This study evaluated the efficacy, safety and tolerability of the novel inhaled phosphodiesterase-4 inhibitor CHF6001 added-on to formoterol in patients with chronic obstructive pulmonary disease (COPD).
METHODS


Randomised, double-blind, placebo- and active-controlled, parallel-group study. Eligible patients had symptomatic COPD, post-bronchodilator forced expiratory volume in 1 s (FEV 1 ) 30-70% predicted, and history of ≥1 moderate/severe exacerbation. Patients were randomised to extrafine CHF6001 400, 800, 1200 or 1600 μg twice daily (BID), budesonide, or placebo for 24 weeks.
PRIMARY OBJECTIVES


To investigate CHF6001 dose-response for pre-dose FEV 1  after 12 weeks, and to identify the optimal dose. Moderate-to-severe exacerbations were a secondary endpoint.
RESULTS


Of 1130 patients randomised, 91.9% completed. Changes from baseline in pre-dose FEV 1  at Week 12 were small in all groups (including budesonide), with no CHF6001 dose-response, and no significant treatment-placebo differences. For moderate-to-severe exacerbations, CHF6001 rate reductions versus placebo were 13-28% (non-significant). In post-hoc analyses, CHF6001 effects were larger in patients with a chronic bronchitis phenotype (rate reductions versus placebo 24-37%; non-significant), and were further increased in patients with chronic bronchitis and eosinophil count ≥150 cells/μL (49-73%, statistically significant for CHF6001 800 and 1600 μg BID). CHF6001 was well tolerated with no safety signal (including in terms of gastrointestinal adverse events).
CONCLUSIONS


CHF6001 had no effect in the primary lung function analysis, although was well-tolerated with no gastrointestinal adverse event signal. Post-hoc analyses focused on exacerbation risk indicate specific patient subgroups who may receive particular benefit from CHF6001.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT02986321 ). Registered 8 Dec 2016.",2020,"Changes from baseline in pre-dose FEV 1  at Week 12 were small in all groups (including budesonide), with no CHF6001 dose-response, and no significant treatment-placebo differences.","['patients with chronic obstructive pulmonary disease (COPD', '400, 800, 1200 or 1600', 'Eligible patients had symptomatic COPD, post-bronchodilator forced expiratory volume in 1\u2009s (FEV 1 ) 30-70% predicted, and history of ≥1 moderate/severe exacerbation', 'COPD', '1130 patients randomised, 91.9% completed']","['budesonide, or placebo', 'CHF6001', 'phosphodiesterase-4 inhibitor CHF6001', 'placebo', 'extrafine CHF6001']","['chronic bronchitis and eosinophil count ≥150 cells/μL', 'efficacy, safety and tolerability', 'Moderate-to-severe exacerbations', 'Efficacy and safety', 'CHF6001 rate reductions', 'tolerated with no safety signal', 'CHF6001 effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4045849', 'cui_str': 'CHF6001'}, {'cui': 'C2936609', 'cui_str': 'Phosphodiesterase 4 inhibitor'}]","[{'cui': 'C0008677', 'cui_str': 'Chronic bronchitis'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C4045849', 'cui_str': 'CHF6001'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.590172,"Changes from baseline in pre-dose FEV 1  at Week 12 were small in all groups (including budesonide), with no CHF6001 dose-response, and no significant treatment-placebo differences.","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK. dsingh@meu.org.uk.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Emirova', 'Affiliation': 'Global Clinical Development, Chiesi, Parma, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Francisco', 'Affiliation': 'Global Clinical Development, Chiesi, Parma, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Santoro', 'Affiliation': 'Global Clinical Development, Chiesi, Parma, Italy.'}, {'ForeName': 'Mirco', 'Initials': 'M', 'LastName': 'Govoni', 'Affiliation': 'Global Clinical Development, Chiesi, Parma, Italy.'}, {'ForeName': 'Marie Anna', 'Initials': 'MA', 'LastName': 'Nandeuil', 'Affiliation': 'Global Clinical Development, Chiesi, Parma, Italy.'}]",Respiratory research,['10.1186/s12931-020-01512-y']
2630,32962710,Reduction of routine use of radiography in patients with ankle fractures leads to lower costs and has no impact on clinical outcome: an economic evaluation.,"BACKGROUND


To evaluate the cost-effectiveness of a reduction in the number of routine radiographs in the follow-up of patients with ankle fractures.
METHODS


We performed an economic evaluation alongside the multicentre, randomised WARRIOR trial. Participants were randomised to a reduced imaging follow-up protocol (i.e. radiographs at week 6 and 12 follow-up obtained on clinical indication) or usual care (i.e. routine radiography at weeks 6 and 12). The Olerud & Molander Ankle Score (OMAS) was used to assess ankle function and the EQ-5D-3L was used to estimate Quality-Adjusted Life Years (QALYs). Costs and resource use were assessed using self-reported questionnaires and medical records, and analysed from a societal perspective. Multiple imputation was used for missing data, and data were analysed using seemingly unrelated regression analysis and bootstrapping.
RESULTS


In total, 246 patients had data available for analysis (reduced imaging = 118; usual care = 128). Fewer radiographs were obtained in the reduced imaging group (median = 4) compared with the usual-care group (median = 5). Functional outcome was comparable in both groups. The difference in QALYs was - 0.008 (95% CI:-0.06 to 0.04) and the difference in OMAS was 0.73 (95% CI:-5.29 to 6.76). Imaging costs were lower in the reduced imaging group (-€48; 95% CI:- €72 to -€25). All other cost categories did not statistically differ between the groups. The probability of the reduced imaging protocol being cost-effectiveness was 0.45 at a wiliness-to-pay of €20,000 per QALY.
CONCLUSIONS


Reducing the number of routine follow-up radiographs has a low probability of being cost-effective compared with usual care. Functional outcome, health-related quality of life and societal costs were comparable in both groups, whereas imaging costs were marginally lower in the reduced imaging group. Given this, adherence to a reduced imaging follow-up protocol for those with routine ankle fractures can be followed without sacrificing quality of care, and may result in reduced costs.
TRIAL REGISTRATION


The trial was registered on 26-05-2014 in the Netherlands Trial Registry, with reference number NL4477 ( www.trialregister.nl/trial/4477 ).",2020,Imaging costs were lower in the reduced imaging group (-€48; 95% CI:- €72 to -€25).,"['patients with ankle fractures', '26-05-2014 in the Netherlands Trial Registry, with reference number NL4477 ( www.trialregister.nl/trial/4477 ', '246 patients had data available for analysis (reduced imaging\u2009=\u2009118; usual care\u2009=\u2009128']","['radiography', 'reduced imaging follow-up protocol (i.e. radiographs at week 6 and 12 follow-up obtained on clinical indication) or usual care (i.e. routine radiography']","['OMAS', 'imaging costs', 'Olerud & Molander Ankle Score (OMAS', 'Imaging costs', 'QALYs', 'Functional outcome, health-related quality of life and societal costs', 'Functional outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",246.0,0.186244,Imaging costs were lower in the reduced imaging group (-€48; 95% CI:- €72 to -€25).,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'van Gerven', 'Affiliation': 'Department of Traumasurgery, Leiden University Medical Center, P.O. Box 9600, 2300, RC, Leiden, the Netherlands. p.van_gerven@lumc.nl.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Movement Sciences research institute, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Rubinstein', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Movement Sciences research institute, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Termaat', 'Affiliation': 'Department of Traumasurgery, Leiden University Medical Center, P.O. Box 9600, 2300, RC, Leiden, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'El Moumni', 'Affiliation': 'Department of Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Zuidema', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Krijnen', 'Affiliation': 'Department of Traumasurgery, Leiden University Medical Center, P.O. Box 9600, 2300, RC, Leiden, the Netherlands.'}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Schipper', 'Affiliation': 'Department of Traumasurgery, Leiden University Medical Center, P.O. Box 9600, 2300, RC, Leiden, the Netherlands.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Movement Sciences research institute, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC health services research,['10.1186/s12913-020-05725-1']
2631,32962724,A whole family-based physical activity promotion intervention: findings from the families reporting every step to health (FRESH) pilot randomised controlled trial.,"INTRODUCTION


This study assessed the feasibility and acceptability of FRESH (Families Reporting Every Step to Health), a theory-based child-led family physical activity (PA) intervention delivered online. We also assessed the preliminary effectiveness of the intervention on outcomes of interest and whether pre-specified criteria were met to progress to a full-scale definitive trial.
METHODS


In a three-armed randomised pilot trial, 41 families (with a 7-11-year-old index child) were allocated to a: 'family' (FAM), 'pedometer-only' (PED), or a no-treatment control (CON) arm. The FAM arm received access to the FRESH website, allowing participants to select step challenges to 'travel' to target cities around the world, log their steps, and track progress as families virtually globetrot. FAM and PED arms also received family sets of pedometers. All family members could participate in the evaluation. Physical (e.g., fitness, blood pressure), psychosocial (e.g., social support), behavioural (e.g., objectively-measured PA), and economic (e.g., expenditure for PA) data were collected at baseline, 8- and 52-weeks.
RESULTS


At 8- and 52-weeks, 98 and 88% of families were retained, respectively. Most children liked participating in the study (> 90%) and thought it was fun (> 80%). Compared to the PED (45%) and CON (39%) arms, a higher percentage of children in the FAM (81%) arm reported doing more activities with their family. Adults agreed that FRESH encouraged their family do more PA and made their family more aware of the amount of PA they do. No notable between-group differences were found for childrens' minutes in moderate-to-vigorous PA. Sizeable changes of 9.4 (95%CI: 0.4, 18.4) and 15.3 (95%CI: 6.0, 24.5) minutes in moderate-to-vigorous PA was found for adults in the FAM group compared to those in the PED or CON groups, respectively. No other notable differences were found.
CONCLUSION


This study demonstrates feasibility and acceptability of the FRESH intervention. All progression criteria were at least partially satisfied. However, we failed to recruit the target sample size and did not find a signal of effectiveness on PA particularly long-term or in children. Further refinements are required to progress to a full-scale trial.
TRIAL REGISTRATION


This study was prospectively registered ( ISRCTN12789422 ) on 16/03/2016.",2020,Most children liked participating in the study (> 90%) and thought it was fun (> 80%).,['41 families (with a 7-11-year-old index child'],"[""family' (FAM), 'pedometer-only' (PED), or a no-treatment control (CON"", 'FRESH', 'A whole family-based physical activity promotion intervention', 'FRESH intervention']","['Physical (e.g., fitness, blood pressure), psychosocial (e.g., social support), behavioural (e.g., objectively-measured PA), and economic (e.g., expenditure for PA) data']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}]",41.0,0.0421623,Most children liked participating in the study (> 90%) and thought it was fun (> 80%).,"[{'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Guagliano', 'Affiliation': 'MRC Epidemiology Unit and Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK. Justin.Guagliano@mrc-epid.cam.ac.uk.'}, {'ForeName': 'Sofie M', 'Initials': 'SM', 'LastName': 'Armitage', 'Affiliation': 'MRC Epidemiology Unit and Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Helen Elizabeth', 'Initials': 'HE', 'LastName': 'Brown', 'Affiliation': 'MRC Epidemiology Unit and Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Coombes', 'Affiliation': 'Norwich Medical School and Centre for Diet and Activity Research, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Fusco', 'Affiliation': 'Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Centre for Family Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Norwich Medical School and Centre for Diet and Activity Research, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Morton', 'Affiliation': 'MRC Epidemiology Unit and Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Esther M F', 'Initials': 'EMF', 'LastName': 'van Sluijs', 'Affiliation': 'MRC Epidemiology Unit and Centre for Diet and Activity Research, University of Cambridge, Cambridge, UK.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01025-3']
2632,32962735,Dietary mannose supplementation in phosphomannomutase 2 deficiency (PMM2-CDG).,"BACKGROUND


PMM2-CDG (CDG-Ia) is the most frequent N-glycosylation disorder. While supplying mannose to PMM2-deficient fibroblasts corrects the altered N-glycosylation in vitro, short term therapeutic approaches with mannose supplementation in PMM2-CDG patients have been unsuccessful. Mannose found no further mention in the design of a potential therapy for PMM2-CDG in the past years, as it applies to be ineffective. This retrospective study analyzes the first long term mannose supplementation in 20 PMM2-CDG patients. Mannose was given at a total of 1-2 g mannose/kg b.w./d divided into 5 single doses over a mean time of 57,75 ± 25,85 months. Protein glycosylation, blood mannose concentration and clinical presentation were monitored in everyday clinical practice.
RESULTS


After a mean time period of more than 1 year the majority of patients showed significant improvements in protein glycosylation.
CONCLUSION


Dietary mannose supplementation shows biological effects in PMM2-CDG patients improving glycosylation in the majority of patients. A double-blind randomized study is needed to examine the role of mannose in the design of a therapy for children with PMM2-CDG in more detail.",2020,"Mannose found no further mention in the design of a potential therapy for PMM2-CDG in the past years, as it applies to be ineffective.","['20 PMM2-CDG patients', 'children with PMM2-CDG in more detail', 'phosphomannomutase 2 deficiency (PMM2-CDG']","['PMM2-CDG', 'Dietary mannose supplementation']","['Protein glycosylation, blood mannose concentration and clinical presentation', 'protein glycosylation', 'biological effects']","[{'cui': 'C0349653', 'cui_str': 'Carbohydrate-deficient glycoprotein syndrome type I'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0349653', 'cui_str': 'Carbohydrate-deficient glycoprotein syndrome type I'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0024742', 'cui_str': 'Mannose'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0376322', 'cui_str': 'Protein Glycosylation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0024742', 'cui_str': 'Mannose'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",20.0,0.0379872,"Mannose found no further mention in the design of a potential therapy for PMM2-CDG in the past years, as it applies to be ineffective.","[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Taday', 'Affiliation': ""Department of General Pediatrics, University Children's Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Grüneberg', 'Affiliation': ""Department of General Pediatrics, University Children's Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany.""}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'DuChesne', 'Affiliation': ""Department of General Pediatrics, University Children's Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany.""}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Reunert', 'Affiliation': ""Department of General Pediatrics, University Children's Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany.""}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Marquardt', 'Affiliation': ""Department of General Pediatrics, University Children's Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany. marquat@uni-muenster.de.""}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01528-z']
2633,32962743,Neuroplasticity induced by general anaesthesia: study protocol for a randomised cross-over clinical trial exploring the effects of sevoflurane and propofol on the brain - A 3-T magnetic resonance imaging study of healthy volunteers.,"BACKGROUND


Although used extensively worldwide, the effects of general anaesthesia on the human brain remain largely elusive. Moreover, general anaesthesia may contribute to serious conditions or adverse events such as postoperative cognitive dysfunction and delirium. To understand the basic mechanisms of general anaesthesia, this project aims to study and compare possible de novo neuroplastic changes induced by two commonly used types of general anaesthesia, i.e. inhalation anaesthesia by sevoflurane and intravenously administered anaesthesia by propofol. In addition, we wish to to explore possible associations between neuroplastic changes, neuropsychological adverse effects and subjective changes in fatigue and well-being.
METHODS


This is a randomised, participant- and assessor-blinded, cross-over clinical trial. Thirty healthy volunteers (male:female ratio 1:1) will be randomised to general anaesthesia by either sevoflurane or propofol. Multimodal magnetic resonance imaging (MRI) of the brain will be performed before and after general anaesthesia and repeated after 1 and 8 days. Each magnetic resonance imaging session will be accompanied by cognitive testing and questionnaires on fatigue and well-being. After a wash-out period of 4 weeks, the volunteers will receive the other type of anaesthetic (sevoflurane or propofol), followed by the same series of tests. Primary outcomes: changes in T1-weighted 3D anatomy and diffusion tensor imaging.
SECONDARY OUTCOMES


changes in resting-state functional magnetic resonance imaging, fatigue, well-being, cognitive function, correlations between magnetic resonance imaging findings and the clinical outcomes (questionnaires and cognitive function). Exploratory outcomes: changes in cerebral perfusion and oxygen metabolism, lactate, and response to visual stimuli.
DISCUSSION


To the best of our knowledge, this is the most extensive and advanced series of studies with head-to-head comparison of two widely used methods for general anaesthesia. Recruitment was initiated in September 2019.
TRIAL REGISTRATION


Approved by the Research Ethics Committee in the Capital Region of Denmark, ref. H-18028925 (6 September 2018). EudraCT and Danish Medicines Agency: 2018-001252-35 (23 March 2018). www.clinicaltrials.gov , ID: NCT04125121 . Retrospectively registered on 10 October 2019.",2020,"SECONDARY OUTCOMES


changes in resting-state functional magnetic resonance imaging, fatigue, well-being, cognitive function, correlations between magnetic resonance imaging findings and the clinical outcomes (questionnaires and cognitive function).","['Thirty healthy volunteers (male:female ratio 1:1', 'healthy volunteers']","['sevoflurane and intravenously administered anaesthesia by propofol', 'sevoflurane or propofol', 'sevoflurane and propofol', 'anaesthetic (sevoflurane or propofol', 'Multimodal magnetic resonance imaging (MRI', 'EudraCT']","['resting-state functional magnetic resonance imaging, fatigue, well-being, cognitive function, correlations between magnetic resonance imaging findings and the clinical outcomes (questionnaires and cognitive function', 'cerebral perfusion and oxygen metabolism, lactate, and response to visual stimuli', 'T1-weighted 3D anatomy and diffusion tensor imaging']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}]",30.0,0.116675,"SECONDARY OUTCOMES


changes in resting-state functional magnetic resonance imaging, fatigue, well-being, cognitive function, correlations between magnetic resonance imaging findings and the clinical outcomes (questionnaires and cognitive function).","[{'ForeName': 'Signe Sloth', 'Initials': 'SS', 'LastName': 'Madsen', 'Affiliation': 'Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark. signe.sloth.madsen@regionh.dk.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Møller', 'Affiliation': 'Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Karsten Skovgaard', 'Initials': 'KS', 'LastName': 'Olsen', 'Affiliation': 'Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Mark Bitsch', 'Initials': 'MB', 'LastName': 'Vestergaard', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, University of Copenhagen, Valdemar Hansens Vej 1-23, entrance 5, 2600, Glostrup, Denmark.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Lindberg', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, University of Copenhagen, Valdemar Hansens Vej 1-23, entrance 5, 2600, Glostrup, Denmark.'}, {'ForeName': 'Henrik Bo Wiberg', 'Initials': 'HBW', 'LastName': 'Larsson', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mårtensson', 'Affiliation': 'Faculty of Medicine, Department of Clinical Sciences Lund, Logopedics, Phoniatrics and Audiology, Lund University, 22100 Lund, Sweden.'}, {'ForeName': 'Mads U', 'Initials': 'MU', 'LastName': 'Werner', 'Affiliation': 'Multidisciplinary Pain Center, The Neuroscience Center, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Sofia Alexandra Gaspar', 'Initials': 'SAG', 'LastName': 'Santos', 'Affiliation': 'Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Mohammad Sohail', 'Initials': 'MS', 'LastName': 'Asghar', 'Affiliation': 'Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}]",Trials,['10.1186/s13063-020-04468-y']
2634,32962749,A tai chi/qigong intervention for older adults living with HIV: a study protocol of an exploratory clinical trial.,"BACKGROUND


Almost half of people living with HIV (PLWH) in the USA are over 50 years of age; this is expected to increase to 70% by 2020. Yet, few interventions exist for older PLWH that address psychological and physical symptoms combined, both prevalent in this population. There is a need to find innovative and accessible interventions that can help older PLWH to manage their symptoms. Mind-body interventions, like tai chi/qigong (TCQ), improve both physical and psychological health. TCQ is a series of slow, low-impact meditative movements that integrates breathwork, meditation, and stances.
METHODS


The present study is an exploratory clinical trial that will evaluate the acceptability and feasibility of a 12-week, small group TCQ intervention (n = 24), a sham qigong control condition (n = 24), and a standard of care control condition (n = 24) for older people living with HIV/AIDS. It will also explore any preliminary associations between the TCQ intervention and symptom alleviation. Participants will be recruited from community-based health and social services organizations in Miami, FL, and randomized to one of the 3 conditions.
DISCUSSION


We will assess feasibility and acceptability through questionnaires and adherence to TCQ. We will assess preliminary associations with symptoms such as depression, anxiety, social support, chronic HIV-related fatigue, and clinical outcomes. These will be described through proportions, means, and changes over time through graphing techniques. Outcomes will be assessed at baseline, at post-intervention, and at 3 months follow-up. These preliminary analyses also will provide information necessary to estimate effect size and power needed for a larger clinical trial.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03840525 . Registered on 16 July 2018.",2020,"Mind-body interventions, like tai chi/qigong (TCQ), improve both physical and psychological health.","['people living with HIV (PLWH', 'older adults living with HIV', 'older people living with HIV/AIDS', 'Participants will be recruited from community-based health and social services organizations in Miami, FL, and randomized to one of the 3 conditions']","['TCQ', 'tai chi/qigong intervention', 'Mind-body interventions, like tai chi/qigong (TCQ', 'sham qigong control condition (n\u2009=\u200924), and a standard of care control condition', 'small group TCQ intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.134083,"Mind-body interventions, like tai chi/qigong (TCQ), improve both physical and psychological health.","[{'ForeName': 'Gladys E', 'Initials': 'GE', 'LastName': 'Ibañez', 'Affiliation': 'Department of Epidemiology, Florida International University, 11200 SW 8th St AHC5, Miami, FL, 33199, USA. gibanez@fiu.edu.'}, {'ForeName': 'Kristopher', 'Initials': 'K', 'LastName': 'Fennie', 'Affiliation': 'Division of Natural Sciences, New College of Florida, 5800 Bay Shore Road, Sarasota, FL, 34243, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Larkey', 'Affiliation': 'College of Nursing and Health Innovation, Arizona State University, 550 N 3rd St, Phoenix, AZ, 85004, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics, Florida International University, 11200 SW 8th St AHC5, Miami, FL, 33199, USA.'}, {'ForeName': 'Angel B', 'Initials': 'AB', 'LastName': 'Algarin', 'Affiliation': 'Department of Epidemiology, Florida International University, 11200 SW 8th St AHC5, Miami, FL, 33199, USA.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Valdivia', 'Affiliation': 'Department of Biostatistics, Florida International University, 11200 SW 8th St AHC5, Miami, FL, 33199, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lavretsky', 'Affiliation': 'Department of Psychiatry, Semel Institute for Neuroscience and Human Behavior, The University of California, Los Angeles (UCLA), 760 Westwood Plaza, Los Angeles, CA, 90095, USA.'}]",Trials,['10.1186/s13063-020-04728-x']
2635,32962799,"Letter to the Editor on ""Chronic Pain Self-Management Support With Pain Science Education and Exercise (COMMENCE) for People With Chronic Pain and Multiple Comorbidities: A Randomized Controlled Trial"".",,2020,,['People With Chronic Pain and Multiple Comorbidities'],['Pain Science Education and Exercise'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.145114,,"[{'ForeName': 'Erika T', 'Initials': 'ET', 'LastName': 'Yih', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School and Spaulding Rehabilitation Hospital, Boston, MA.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Silver', 'Affiliation': ""Department of Physical Medicine and Rehabilitation, Harvard Medical School, Massachusetts General Hospital, Brigham and Women's Hospital, and Spaulding Rehabilitation Hospital, Boston, MA.""}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.06.032']
2636,32962936,Sugammadex for Fast-Track Surgery in Children Undergoing Cardiac Surgery: A Randomized Controlled Study.,"OBJECTIVE


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


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


University hospital.
PARTICIPANTS


The study comprised 60 children undergoing cardiac surgery.
INTERVENTIONS


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


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


Sugammadex can shorten the extubation time and reduce the incidence of postoperative atelectasis, with fewer adverse events, in children undergoing cardiac surgery. It may be beneficial to use sugammadex for fast-track surgery in children undergoing cardiac surgery.",2020,"Sugammadex can shorten the extubation time and reduce the incidence of postoperative atelectasis, with fewer adverse events, in children undergoing cardiac surgery.","['60 children undergoing cardiac surgery', 'Children Undergoing Cardiac Surgery', 'University hospital', 'children undergoing cardiac surgery']","['sugammadex', 'neostigmine, 30 µg/kg, and atropine, 15 µg/kg', 'Sugammadex']","['hospitalization expenses', 'safety and efficacy', 'extubation time', 'recovery time to a train-of-four of 0.9 and extubation time', 'heart rate', 'incidence of postoperative atelectasis', 'length of hospital stay', 'mean arterial pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0340074', 'cui_str': 'Postoperative atelectasis'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",60.0,0.179327,"Sugammadex can shorten the extubation time and reduce the incidence of postoperative atelectasis, with fewer adverse events, in children undergoing cardiac surgery.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Wenzhou Central Hospital, Wenzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Department of Anesthesiology, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Women and Children's Hospital of Jiaxing University, Jiaxing, China. Electronic address: zhang650679@163.com.""}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.08.069']
2637,32962950,Correction of the knee coronal plane deformity using the screws plus reconstruction plate versus cannulated screws.,"INTRODUCTION


Knee angular deformity is a common finding occurring in the childhood that can cause gait disturbances and early compartment osteoarthritis. Despite various surgical approaches presented to correct the angular deformities of the knee, there is still a search for the best approach. Thus, the present study was conducted to compare the results of using cannulated screw (CS) versus screw plus reconstruction plate (SpRP) for correction of angular deformities through a two-year follow-up study.
HYPOTHESIS


Percutaneous CS implantation is as efficacious as SpRP implantation for the correction of angular deformities of the knee.
MATERIAL AND METHODS


This randomised clinical trial (RCT) was conducted on 63 patients with angular deformities who were randomly divided into two groups including treatment with cannulated screw (CS) (n=32) and treatment with screw plus reconstruction plate (SpRP) (n=31). All the patients underwent the alignment view radiography of both lower limbs before surgical procedure and then within 3, 6, 12, 18 months and 2 years following the surgery. Afterwards, the patients' mechanical axis of the knees, medial proximal tibial angle (MPTA), lateral distal femoral angle (LDFA), and varus/valgus angles were assessed and compared.
RESULTS


Results of the study showed that MPTA and LDFA significantly turned to the normal range during the 18 months follow-up in both treatment groups (p-value<0.001). Varus and valgus angles were corrected in both techniques as well postoperatively (p-value<0.001). Ultimate correction was achieved earlier in the CS treated group (12 months versus 18 months later).
DISCUSSION


Findings of the study revealed that the percutaneous CS implantation was successful similar to the SpRP implantation for correction of the angular deformity, while earlier ultimate angular correction and less pain complaint were among the superiorities of the CS.
LEVEL OF THE STUDY


II, comparative prospective study.",2020,Varus and valgus angles were corrected in both techniques as well postoperatively (p-value<0.001).,['63 patients with angular deformities'],"['screws plus reconstruction plate versus cannulated screws', 'cannulated screw (CS) versus screw plus reconstruction plate (SpRP', 'Percutaneous CS implantation', 'cannulated screw (CS', 'percutaneous CS implantation', 'screw plus reconstruction plate (SpRP']","['Varus and valgus angles', 'MPTA and LDFA', 'pain complaint', 'mechanical axis of the knees, medial proximal tibial angle (MPTA), lateral distal femoral angle (LDFA), and varus/valgus angles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]","[{'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",63.0,0.0217714,Varus and valgus angles were corrected in both techniques as well postoperatively (p-value<0.001).,"[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Tahririan', 'Affiliation': 'Department of Orthopedics, Kashani Hospital, Isfahan, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Mohammadsharifi', 'Affiliation': 'Department of Orthopedics, Kashani Hospital, Isfahan, Iran. Electronic address: iman.m.sharifi@gmail.com.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.04.020']
2638,32962980,A prognostic model based on PAM50 and clinical variables (PAM50MET) for metastatic hormone-receptor-positive HER2-negative breast cancer.,"PURPOSE


Predicting prognosis in HR+/HER2-negative MBC might be clinically useful; however, no validated prognostic biomarkers exist in this setting to date.
EXPERIMENTAL DESIGN


In phase III, EGF30008 trial, 484 patients with HER2-negative MBC who received letrozole and placebo or lapatinib were selected. PAM50 data, ECOG PS, visceral disease, number of metastasis, biopsy type, and age were evaluated. A progression-free survival (PFS) Cox model was evaluated. The final model (PAM50MET) with a prespecified cutoff was validated in patients (n=261) with HR+/HER2-negative aBC from BOLERO-2 (phase III trial that evaluated exemestane and placebo or everolimus).
RESULTS


In EGF30008, prognostic models with PAM50 plus clinical variables yielded higher C-index values versus models with only PAM50 or clinical variables. The PAM50MET model combined 21 variables: 2 PAM50 subtypes, basal signature, 14 genes, and 4 clinical variables. In EGF30008, the optimized cutoff was associated with PFS (hazard ratio [HR]=0.37; 95% confidence interval [CI] 0.29-0.47;  P <0.0001) and overall survival (OS; HR=0.37; 0.27-0.51;  P <0.0001). The median (months) (95% CI) PFS and OS were 22.24 (19.0-24.9) and not reached in PAM50MET-low versus 9.13 (8.15-11.0) and 33.0 (28.0-40.0) in PAM50MET-high groups, respectively. In BOLERO-2, the PAM50MET-low was associated with better PFS (HR=0.72; 95% CI 0.53-0.96;  P =0.028) and OS (HR=0.51; 95% CI 0.35-0.69;  P <0.0001). The median (months) (95% CI) PFS and OS were 6.93 (5.57-11.0) and 36.9 (33.4-NA) in PAM50MET-low versus 5.23 (4.2-6.8) and 23.5 (20.2-28.3) in PAM50MET-high groups, respectively.
CONCLUSION


PAM50MET is prognostic in HR+/HER2-negative MBC, and further evaluation might help identify candidates for ET only or novel therapies.",2020,"In BOLERO-2, the PAM50MET-low was associated with better PFS (HR=0.72; 95% CI 0.53-0.96;  P =0.028) and OS (HR=0.51; 95% CI 0.35-0.69;  P <0.0001).","['patients (n=261) with HR+/HER2-negative aBC from BOLERO-2', '484 patients with HER2-negative MBC who received']","['exemestane and placebo or everolimus', 'letrozole and placebo or lapatinib']","['A progression-free survival (PFS', 'PAM50 data, ECOG PS, visceral disease, number of metastasis, biopsy type, and age', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0244436', 'cui_str': 'Bolero'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}]","[{'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449798', 'cui_str': 'Number of metastases'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",484.0,0.0728994,"In BOLERO-2, the PAM50MET-low was associated with better PFS (HR=0.72; 95% CI 0.53-0.96;  P =0.028) and OS (HR=0.51; 95% CI 0.35-0.69;  P <0.0001).","[{'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'Department of Medical Oncology, Hospital Clinic de Barcelona alprat@clinic.cat.'}, {'ForeName': 'Yi-Hsuan', 'Initials': 'YH', 'LastName': 'Tsai', 'Affiliation': 'Pharmacology, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'Department of Medical Oncology, Hospital Clinic de Barcelona.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'SOLTI breast cancer research group.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Adamo', 'Affiliation': 'Medical Oncology, Hospital Clinic.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': 'Medical Oncology, Translational Genomics and Targeted Therapeutics in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS).'}, {'ForeName': 'Fara', 'Initials': 'F', 'LastName': 'Brasó-Maristany', 'Affiliation': 'Oncology, Hospital Clinic of Barcelona.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galván', 'Affiliation': 'Medical Oncology, Hospital Clinic.'}, {'ForeName': 'Jan C', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Precision Medicine, Novartis Pharma AG.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rodrik-Outmezguine', 'Affiliation': 'OPM, Novartis (United States).'}, {'ForeName': 'Stephen R D', 'Initials': 'SRD', 'LastName': 'Johnston', 'Affiliation': 'Breast Unit, Royal Marsden Hospital.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Ciruelos', 'Affiliation': 'Medical Oncology Department, Hospital 12 de Octubre.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Parker', 'Affiliation': 'Genetics, University of North Carolina School of Medicine.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2793']
2639,32962981,Cognitive Function Following Diabetic Ketoacidosis in Children With New-Onset or Previously Diagnosed Type 1 Diabetes.,"OBJECTIVE


This study assessed whether a single diabetic ketoacidosis (DKA) episode is associated with cognitive declines in children with newly diagnosed type 1 diabetes and whether the same is true in children who had previously been diagnosed after accounting for variations in glycemic control and other relevant factors.
RESEARCH DESIGN AND METHODS


We prospectively enrolled 758 children, 6-18 years old, who presented with DKA in a randomized multisite clinical trial evaluating intravenous fluid protocols for DKA treatment. DKA was moderate/severe in 430 children and mild in 328 children. A total of 392 children with DKA had new onset of type 1 diabetes, and the rest were previously diagnosed. Neurocognitive assessment occurred 2-6 months after the DKA episode. A comparison group of 376 children with type 1 diabetes, but no DKA exposure, was also enrolled.
RESULTS


Among all patients, moderate/severe DKA was associated with lower intelligence quotient (IQ) (β = -0.12,  P  < 0.001), item-color recall (β = -0.08,  P  = 0.010), and forward digit span (β = -0.06,  P  = 0.04). Among newly diagnosed patients, moderate/severe DKA was associated with lower item-color recall (β = -0.08,  P  = 0.04). Among previously diagnosed patients, repeated DKA exposure and higher HbA 1c  were independently associated with lower IQ (β = -0.10 and β = -0.09, respectively,  P  < 0.01) and higher HbA 1c  was associated with lower item-color recall (β = -0.10,  P  = 0.007) after hypoglycemia, diabetes duration, and socioeconomic status were accounted for.
CONCLUSIONS


A single DKA episode is associated with subtle memory declines soon after type 1 diabetes diagnosis. Sizable IQ declines are detectable in children with known diabetes, suggesting that DKA effects may be exacerbated in children with chronic exposure to hyperglycemia.",2020,"Among all patients, moderate/severe DKA was associated with lower intelligence quotient (IQ) (β = -0.12,  P  < 0.001), item-color recall (β = -0.08,  P  = 0.010), and forward digit span (β = -0.06,  P  = 0.04).","['children with newly diagnosed type 1 diabetes', 'children with chronic exposure to hyperglycemia', '430 children and mild in 328 children', '376 children with type 1 diabetes, but no DKA exposure, was also enrolled', 'children with known diabetes', 'Children With New-Onset or Previously Diagnosed Type 1 Diabetes', '392 children with DKA had new onset of type 1 diabetes, and the rest were previously diagnosed', 'We prospectively enrolled 758 children, 6-18 years old, who presented with DKA in a randomized multisite clinical trial evaluating intravenous fluid protocols for DKA treatment']",['DKA'],"['lower intelligence quotient (IQ', 'forward digit span', 'item-color recall', 'Cognitive Function', 'hypoglycemia, diabetes duration, and socioeconomic status', 'moderate/severe DKA', 'Neurocognitive assessment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}]","[{'cui': 'C0423903', 'cui_str': 'Low intelligence'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",758.0,0.0520046,"Among all patients, moderate/severe DKA was associated with lower intelligence quotient (IQ) (β = -0.12,  P  < 0.001), item-color recall (β = -0.08,  P  = 0.010), and forward digit span (β = -0.06,  P  = 0.04).","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Ghetti', 'Affiliation': 'Department of Psychology, University of California, Davis, Davis, CA sghetti@ucdavis.edu.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Emergency Medicine, UC Davis Health, UC Davis School of Medicine, Sacramento, CA.'}, {'ForeName': 'Arleta', 'Initials': 'A', 'LastName': 'Rewers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, University of Colorado Denver, Aurora, CO.""}, {'ForeName': 'Sage R', 'Initials': 'SR', 'LastName': 'Myers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Jeff E', 'Initials': 'JE', 'LastName': 'Schunk', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Stoner', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Garro', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, Rhode Island Hospital, The Warren Alpert Medical School, Brown University, Providence, RI.'}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Quayle', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine in St. Louis, St. Louis, MO.""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Brown', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's National Medical Center, The School of Medicine & Health Sciences, The George Washington University, Washington, DC.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Trainor', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Tzimenatos', 'Affiliation': 'Department of Emergency Medicine, UC Davis Health, UC Davis School of Medicine, Sacramento, CA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DePiero', 'Affiliation': 'Division of Emergency Medicine, Nemours/Alfred I. duPont Hospital for Children, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'McManemy', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Lise E', 'Initials': 'LE', 'LastName': 'Nigrovic', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Maria Y', 'Initials': 'MY', 'LastName': 'Kwok', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, New York Presbyterian Morgan Stanley Children's Hospital, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY.""}, {'ForeName': 'Clinton S', 'Initials': 'CS', 'LastName': 'Perry', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, Davis, CA.'}, {'ForeName': 'Cody S', 'Initials': 'CS', 'LastName': 'Olsen', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Glaser', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc20-0187']
2640,32920614,Post preparation: cleanness achieved by different irrigating protocols.,"The aim of this study was to evaluate the ability of different irrigation protocols to remove from the walls of the root canal and entrance to dentinal tubules the smear layer produced during preparation for a fiber post. Fifty decoronated human lower premolars were treated endodontically and the apical third of the canal was filled with a single gutta-percha point using warm vertical compaction. Ten millimeters were left free for post preparation, which was done by sequential use of a Largo #1 drill and Exacto #3 pilot drill (Angelus, Brazil), with irrigation with distilled water upon each instrument change. Samples were distributed randomly into 5 groups (n=10). G 1: No irrigation after post preparation. G 2: Distilled water activated for 60 s + distilled water. G 3: 5.25% NaOCl 15 s+ distilled water. G 4: 17% EDTA (Farmadental, Argentina) 60 s + 5.25% NaOCl 15 s + distilled water. G 5: 10% polyacrylic acid (Densell) 15 s + distilled water. Irrigant was activated mechanically with a low-speed conical brush. Roots were then split longitudinally in vestibular-lingual direction. Each surface was observed under SEM in its different thirds. Microphotographs were taken at 150X and 600X magnification and results analyzed statistically using Kruskall Wallis and Friedman tests (p<0.05). The results [mean (standard deviation)] were: for 150X: G1 11.00 (1.33), G2 7.50 (3.13), G3 6.30 (2.58), G4 2.20 (2.80), G5 4.30 (1.50), and for 600X G1 11.40 (0.84), G2 10.00 (1.94), G3 7.70 (3.33), G4 5.80 (3.70), G5 7.20 (2.65). The statistical analysis showed significant differences between irrigants (p<0.05) but not between root thirds (p>0.05). The EDTA+NaOCl combination and polyacrylic acid showed greater capacity to remove the smear layer created during post preparation.",2020,The EDTA+NaOCl combination and polyacrylic acid showed greater capacity to remove the smear layer created during post preparation.,['Fifty decoronated human lower premolars'],['polyacrylic acid (Densell) 15 s + distilled water'],[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0054720', 'cui_str': 'Carbomer-940'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",[],10.0,0.0283356,The EDTA+NaOCl combination and polyacrylic acid showed greater capacity to remove the smear layer created during post preparation.,"[{'ForeName': 'Marcela L', 'Initials': 'ML', 'LastName': 'Roitman', 'Affiliation': 'Universidad de Buenos Aires, Facultad de Odontología, Cátedra de Endodoncia, Buenos Aires, Argentina. mlroitman@gmail.com.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Picca', 'Affiliation': 'Universidad de Buenos Aires, Facultad de Odontología, Cátedra de Materiales Dentales, Buenos Aires, Argentina.'}, {'ForeName': 'Ricardo L', 'Initials': 'RL', 'LastName': 'Macchi', 'Affiliation': 'Universidad de Buenos Aires, Facultad de Odontología, Cátedra de Materiales Dentales, Buenos Aires, Argentina.'}]",Acta odontologica latinoamericana : AOL,[]
2641,32963063,Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitudinal follow-up protocol.,"INTRODUCTION


Through addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.
METHODS AND ANALYSIS


Women participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.
DISCUSSION


Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.
ETHICS AND DISSEMINATION


The ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more 'mainstream' strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.
TRAIL REGISTRATION NUMBER


This trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.",2020,"DISCUSSION


Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.
","['Australian primary care patients', 'Women participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey']",[],['uptake of LARC'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],[],,0.172989,"DISCUSSION


Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.
","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mazza', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Victoria, Australia Danielle.Mazza@monash.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Amos', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Watson', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGeechan', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'Centre for Health Economics Research & Evaluation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Peipert', 'Affiliation': 'Department of Obstetrics & Gynecology, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Lucke', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Taft', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'McNamee', 'Affiliation': 'Family Planning Victoria, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kirsten I', 'Initials': 'KI', 'LastName': 'Black', 'Affiliation': 'Royal Prince Alfred Hospital, The University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-035895']
2642,32963066,Impact of a two-way short message service (SMS) to support maternally administered childhood mid-upper arm circumference monitoring and expand malnutrition screening in Kenya: the Mama Aweza trial protocol.,"INTRODUCTION


Over 52 million children under 5 years of age become wasted each year, but only 17% of these children receive treatment. Novel methods to identify and deliver treatment to malnourished children are necessary to achieve the sustainable development goals target for child health. Mobile health (mHealth) programmes may provide an opportunity to rapidly identify malnourished children in the community and link them to care.
METHODS AND ANALYSIS


This randomised controlled trial will recruit 1200 children aged 6-12 months at routine vaccine appointments in Migori and Homa Bay Counties, Kenya. Caregiver-infant dyads will be randomised to either a maternally administered malnutrition monitoring system (MAMMS) or standard of care (SOC). Study staff will train all caregivers to measure their child's mid-upper arm circumference (MUAC). Caregivers in the MAMMS arm will be given two colour coded and graduated insertion MUAC tapes and be enrolled in a mHealth system that sends weekly short message service (SMS) messages prompting caregivers to measure and report their child's MUAC by SMS. Caregivers in the SOC arm will receive routine monitoring by community health volunteers coupled with a quarterly visit from study staff to ensure adequate screening coverage. The primary outcome is identification of childhood malnutrition, defined as MUAC <12.5 cm, in the MAMMS arm compared with the SOC arm. Secondary outcomes will assess the accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition among children 6-18 months of age. Finally, we will explore the acceptability, fidelity and feasibility of implementing the MAMMS within existing nutrition programmes.
ETHICS AND DISSEMINATION


The study was approved by review boards at the University of Washington and the Kenya Medical Research Institute. A data and safety monitoring board has been convened, and the results of the trial will be published in peer-reviewed scientific journals, presented at appropriate conferences and to key stakeholders.
TRIAL REGISTRATION NUMBER


NCT03967015; Pre-results.",2020,Secondary outcomes will assess the accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition among children 6-18 months of age.,"['1200 children aged 6-12 months at routine vaccine appointments in Migori and Homa Bay Counties, Kenya', 'malnourished children', 'Kenya']","['MAMMS', 'maternally administered malnutrition monitoring system (MAMMS) or standard of care (SOC', 'two-way short message service (SMS', 'Mobile health (mHealth) programmes']","['accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition', 'identification of childhood malnutrition']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]",1200.0,0.129427,Secondary outcomes will assess the accuracy of maternal versus health worker MUAC measurements and determinants of acute malnutrition among children 6-18 months of age.,"[{'ForeName': 'Kirkby D', 'Initials': 'KD', 'LastName': 'Tickell', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA kirkbt@uw.edu.'}, {'ForeName': 'Mareme M', 'Initials': 'MM', 'LastName': 'Diakhate', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jeanne L', 'Initials': 'JL', 'LastName': 'Goodman', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Unger', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Rubin Means', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Keshet', 'Initials': 'K', 'LastName': 'Ronen', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levin', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Esther M', 'Initials': 'EM', 'LastName': 'Choo', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Achieng', 'Affiliation': 'Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Masheti', 'Affiliation': 'Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Benson O', 'Initials': 'BO', 'LastName': 'Singa', 'Affiliation': 'Centre for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Christine J', 'Initials': 'CJ', 'LastName': 'McGrath', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}]",BMJ open,['10.1136/bmjopen-2019-036660']
2643,32963087,Neonatal videolaryngoscopy as a teaching aid: the trainees' perspective.,"INTRODUCTION


Neonatal intubation is a challenging skill to acquire. A randomised controlled trial (RCT) found junior trainees had higher intubation success rates if their supervisor shared their airway view on a videolaryngoscope screen compared with intubations where the supervisor could not see the videolaryngoscope screen. The intubations in the trial were supervised by a group of experienced neonatologists who developed an intubation teaching package that aimed to be informative, consistent and supportive. We surveyed the trainees to assess their experiences of the intubation attempts.
METHODS


Trainees participating in the RCT completed questionnaires anonymously after each intubation attempt. Questionnaires used 5-point Likert scales and free comment sections. Quantitative analysis was performed using descriptive statistics. In a qualitative analysis, free comments were coded to identify central recurring themes.
RESULTS


Two hundred and six questionnaires were completed by 36 trainees. The majority reported that the guidance received during intubation was helpful, the postprocedure feedback was educational and their confidence levels were increased. Trainees appreciated a controlled environment and calm, consistent guidance. They found intubations in the delivery room, those involving unstable infants, large audiences and parental presence more stressful. Responses were positive whether the videolaryngoscope screen was visible or covered, emphasising the importance of consistent guidance. Overall, 16% of intubations were reported as intimidating.
CONCLUSION


The shared airway view offered by videolaryngoscopy was well received. In addition, taking measures to control the setting, with standardised guidance and feedback, improved confidence and created a more positive learning experience.",2020,A randomised controlled trial (RCT) found junior trainees had higher intubation success rates if their supervisor shared their airway view on a videolaryngoscope screen compared with intubations where the supervisor could not see the videolaryngoscope screen.,"['Trainees participating in the RCT completed questionnaires anonymously after each intubation attempt', 'Two hundred and six questionnaires were completed by 36 trainees']",['Neonatal videolaryngoscopy'],"['Questionnaires used 5-point Likert scales and free comment sections', 'positive learning experience', 'intubation success rates']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",206.0,0.0437232,A randomised controlled trial (RCT) found junior trainees had higher intubation success rates if their supervisor shared their airway view on a videolaryngoscope screen compared with intubations where the supervisor could not see the videolaryngoscope screen.,"[{'ForeName': 'Joyce E', 'Initials': 'JE', 'LastName': ""O'Shea"", 'Affiliation': ""Department of Neonatology, Royal Hospital for Children, Glasgow, UK joyce.o'shea@ggc.scot.nhs.uk.""}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Kirolos', 'Affiliation': 'Department of Neonatology, Royal Hospital for Children, Glasgow, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Thio', 'Affiliation': ""Department of Newborn Research, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'C Omar Farouk', 'Initials': 'COF', 'LastName': 'Kamlin', 'Affiliation': ""Department of Newborn Research, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Davis', 'Affiliation': ""Department of Newborn Research, The Royal Women's Hospital, Parkville, Victoria, Australia.""}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2020-319619']
2644,32963103,Neural effects of oxytocin and mimicry in frontotemporal dementia: A randomized cross-over study.,"OBJECTIVE


The objective of this study was to determine whether intranasal oxytocin, alone or in combination with instructed mimicry of facial expressions, would augment neural activity in patients with FTD in brain regions associated with empathy, emotion processing and the simulation network, as indexed by blood-oxygen-level dependent (BOLD) signal during functional magnetic resonance imaging (fMRI).
METHODS


In a placebo-controlled, randomized cross-over design, 28 patients with FTD received 72 IU of intranasal oxytocin or placebo and then completed a fMRI facial expression mimicry task.
RESULTS


Oxytocin alone, and in combination with instructed mimicry, increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
CONCLUSIONS


The findings demonstrate latent capacity to augment neural activity in affected limbic and other frontal and temporal regions during social cognition in patients with FTD, and support the promise and need for further investigation of these interventions as therapeutics in FTD.
CLASSIFICATION OF EVIDENCE


This study provides Class III evidence that a single dose of 72 IU intranasal oxytocin augments BOLD signal in patients with FTD during viewing of emotional facial expressions.",2020,"RESULTS


Oxytocin alone, and in combination with instructed mimicry, increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
","['patients with FTD', 'frontotemporal dementia', 'patients with FTD in brain regions associated with empathy, emotion processing and the simulation network, as indexed by blood-oxygen-level dependent (BOLD) signal during functional magnetic resonance imaging (fMRI', 'patients with FTD during viewing of emotional facial expressions', '28 patients with FTD received 72 IU of']","['intranasal oxytocin, alone or in combination with instructed mimicry of facial expressions', 'oxytocin', 'placebo', 'Oxytocin', 'intranasal oxytocin or placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal dementia'}, {'cui': 'C0236642', 'cui_str': ""Pick's disease""}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0233577', 'cui_str': 'Mimicry'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],28.0,0.3629,"RESULTS


Oxytocin alone, and in combination with instructed mimicry, increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
","[{'ForeName': 'Lindsay D', 'Initials': 'LD', 'LastName': 'Oliver', 'Affiliation': 'From the Graduate Program in Neuroscience, Schulich School of Medicine and Dentistry, Western University, London, OntarioCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, OntarioParkwood Institute Research, London, OntarioDepartment of Psychology, University of British Columbia, VancouverRobarts Research Institute, Western University, London, OntarioBrain and Mind Institute, Department of Psychiatry, Department of Anatomy and Cell Biology, Western University, London, OntarioDepartment of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'From the Graduate Program in Neuroscience, Schulich School of Medicine and Dentistry, Western University, London, OntarioCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, OntarioParkwood Institute Research, London, OntarioDepartment of Psychology, University of British Columbia, VancouverRobarts Research Institute, Western University, London, OntarioBrain and Mind Institute, Department of Psychiatry, Department of Anatomy and Cell Biology, Western University, London, OntarioDepartment of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Coleman', 'Affiliation': 'From the Graduate Program in Neuroscience, Schulich School of Medicine and Dentistry, Western University, London, OntarioCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, OntarioParkwood Institute Research, London, OntarioDepartment of Psychology, University of British Columbia, VancouverRobarts Research Institute, Western University, London, OntarioBrain and Mind Institute, Department of Psychiatry, Department of Anatomy and Cell Biology, Western University, London, OntarioDepartment of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kryklywy', 'Affiliation': 'From the Graduate Program in Neuroscience, Schulich School of Medicine and Dentistry, Western University, London, OntarioCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, OntarioParkwood Institute Research, London, OntarioDepartment of Psychology, University of British Columbia, VancouverRobarts Research Institute, Western University, London, OntarioBrain and Mind Institute, Department of Psychiatry, Department of Anatomy and Cell Biology, Western University, London, OntarioDepartment of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bartha', 'Affiliation': 'From the Graduate Program in Neuroscience, Schulich School of Medicine and Dentistry, Western University, London, OntarioCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, OntarioParkwood Institute Research, London, OntarioDepartment of Psychology, University of British Columbia, VancouverRobarts Research Institute, Western University, London, OntarioBrain and Mind Institute, Department of Psychiatry, Department of Anatomy and Cell Biology, Western University, London, OntarioDepartment of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario.'}, {'ForeName': 'Derek G V', 'Initials': 'DGV', 'LastName': 'Mitchell', 'Affiliation': 'From the Graduate Program in Neuroscience, Schulich School of Medicine and Dentistry, Western University, London, OntarioCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, OntarioParkwood Institute Research, London, OntarioDepartment of Psychology, University of British Columbia, VancouverRobarts Research Institute, Western University, London, OntarioBrain and Mind Institute, Department of Psychiatry, Department of Anatomy and Cell Biology, Western University, London, OntarioDepartment of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Finger', 'Affiliation': 'From the Graduate Program in Neuroscience, Schulich School of Medicine and Dentistry, Western University, London, OntarioCampbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, OntarioParkwood Institute Research, London, OntarioDepartment of Psychology, University of British Columbia, VancouverRobarts Research Institute, Western University, London, OntarioBrain and Mind Institute, Department of Psychiatry, Department of Anatomy and Cell Biology, Western University, London, OntarioDepartment of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario. Elizabeth.Finger@lhsc.on.ca.'}]",Neurology,['10.1212/WNL.0000000000010933']
2645,32970315,"Bioequivalence Study Comparing Fixed-Dose Combination of Clopidogrel and Aspirin with Coadministration of Individual Formulations in Chinese Subjects Under Fed Conditions: A Phase I, Open-Label, Randomized, Crossover Study.","INTRODUCTION


Simultaneous administration of acetylsalicylic acid (ASA) and clopidogrel has demonstrated efficacy in the treatment of acute coronary syndrome. Clopidogrel + ASA in a fixed-dose combination (FDC) provides a pharmaceutical option to enhance adherence to the coadministration of dual antiplatelet therapy (DAPT). Herein, we evaluate the bioequivalence of enteric ASA and clopidogrel in an FDC compared with simultaneous administration of the individual formulations.
METHODS


This study is a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study conducted in healthy Chinese male and female subjects under fed conditions. Subjects were randomized to receive, in each period, a single dose of (1) a combination tablet containing 75-mg clopidogrel and 100-mg enteric ASA (test formulation) or (2) coadministration of one 75-mg clopidogrel tablet and one 100-mg enteric-coated ASA tablet (reference formulations) under fed conditions. Plasma samples were analyzed for ASA, salicylic acid, clopidogrel, and the clopidogrel metabolite SR26334. For ASA, the reference-scaled average bioequivalence (RSABE) analysis was conducted for C max  of ASA because within-subject standard deviation (SD W ) was ≥ 0.294 for log-transformed C max .
RESULTS


The point estimate (test/reference geometric mean ratio) was between 0.80 and 1.25, and the upper one-sided 95% confidence interval (CI) for the scaled average bioequivalence metric was ≤ 0 (-0.08). AUC of ASA as SD W  was < 0.294 for log-transformed AUC last  and AUC. Estimates of 90% CIs for log-transformed AUC last  and AUC ratios were within the bioequivalence range of 0.80 to 1.25 (0.98-1.08 and 1.00-1.10, respectively). For clopidogrel, the 90% CIs for the ratios comparing log-transformed C max , AUC last , and AUC ratios of clopidogrel following administration of test versus reference formulation were calculated using the ABE method and were well within the acceptable range of 0.80 to 1.25 (1.02-1.12, 0.92-0.99, and 0.92-0.98, respectively).
CONCLUSION


FDC of ASA and clopidogrel was bioequivalent to the simultaneous administration of the individual formulations in healthy Chinese subjects under fed conditions.
TRIAL REGISTRATION


CTR20190376.",2020,AUC of ASA as SD W  was < 0.294 for log-transformed AUC,"['healthy Chinese subjects under fed conditions', 'acute coronary syndrome', 'healthy Chinese male and female subjects under fed conditions', 'Chinese Subjects Under Fed Conditions']","['Clopidogrel and Aspirin with Coadministration of Individual Formulations', 'combination tablet containing 75-mg clopidogrel and 100-mg enteric ASA (test formulation) or (2) coadministration of one 75-mg clopidogrel tablet and one 100-mg enteric-coated ASA tablet (reference formulations) under fed conditions', 'clopidogrel', 'Clopidogrel\u2009+\u2009ASA', 'AUC', 'acetylsalicylic acid (ASA) and clopidogrel']","['AUC ratios', 'ratios comparing log-transformed C max , AUC last , and AUC ratios of clopidogrel']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1248670', 'cui_str': 'clopidogrel Oral Tablet'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]",,0.234126,AUC of ASA as SD W  was < 0.294 for log-transformed AUC,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Ming', 'Affiliation': 'Research and Development, Sanofi, New York, USA.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical, Sanofi, Beijing, China.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ping', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Xinghe', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China. wangxh@bjsjth.cn.'}]",Advances in therapy,['10.1007/s12325-020-01486-9']
2646,32970367,Basic Psychological Need-Satisfying Activities during the COVID-19 Outbreak.,"BACKGROUND


The rapidly spreading novel coronavirus outbreak (COVID-19) worldwide may increase fear and stress, and has a cost for people's well-being and their motivation toward activities. In this study, we applied principles from Self-Determination Theory to develop and test activities to satisfy basic psychological needs (autonomy, competence, and relatedness) to enhance the experience of need satisfaction, autonomous self-regulation, and subjective vitality, and to decrease the experience of need frustration, controlled self-regulation, amotivation, and perceived stress.
METHOD


Using a 10-day experimental research design among an Iranian sample (N = 208, M age   = 23.52, SD = 5.00), we randomly allocated participants to either an experimental (basic psychological need-satisfying activities intervention, n = 98) or a control (neutral comparison group, n = 110) condition.
RESULTS


Repeated measure ANCOVA showed that participants in the experimental condition reported greater psychological need satisfaction, autonomous self-regulation, subjective vitality, and lesser psychological need frustration, amotivation, and perceived stress than did participants in the control condition.
CONCLUSION


We conclude that the intervention was successful in helping participants enhance their motives and well-being and reduce their stress when life is surrounded by uncertainty and during social distancing restrictions.",2020,"RESULTS


Repeated measure ANCOVA showed that participants in the experimental condition reported greater psychological need satisfaction, autonomous self-regulation, subjective vitality, and lesser psychological need frustration, amotivation, and perceived stress than did participants in the control condition.
","['Iranian sample (N\xa0=\xa0208, M age  \xa0']","['experimental (basic psychological need-satisfying activities intervention, n\xa0=\xa098) or a control (neutral comparison group, n\xa0=\xa0110) condition']","['psychological need satisfaction, autonomous self-regulation, subjective vitality, and lesser psychological need frustration, amotivation, and perceived stress']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0016770', 'cui_str': 'Feeling frustrated'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",,0.0147129,"RESULTS


Repeated measure ANCOVA showed that participants in the experimental condition reported greater psychological need satisfaction, autonomous self-regulation, subjective vitality, and lesser psychological need frustration, amotivation, and perceived stress than did participants in the control condition.
","[{'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Behzadnia', 'Affiliation': 'Department of Motor Behavior, Faculty of Physical Education and Sport Sciences, University of Tabriz, Tabriz, Iran.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'FatahModares', 'Affiliation': 'Department of Sport Management, Faculty of Physical Education and Sport Sciences, Urmia University, Urmia, Iran.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12228']
2647,32970395,Efficacy of the exhalation delivery system with fluticasone in patients who remain symptomatic on standard nasal steroid sprays.,"BACKGROUND


Standard nasal steroid sprays are often first-line treatment for chronic rhinosinusitis (CRS), but many patients remain symptomatic despite their use. The exhalation delivery system with fluticasone (EDS-FLU) has been shown to be efficacious in mixed populations of symptomatic patients, but the question remains whether benefits would be similar in those already on traditional steroid sprays. The goal of this study was to compare EDS-FLU treatment outcomes in patients who have previously failed nasal steroids.
METHODS


Using pooled data from the NAVIGATE I and II trials, EDS-FLU efficacy was compared in the subgroup treated with a conventional nasal steroid at trial entry (mean duration, ≈3 years) to efficacy in the overall study population. Sensitivity analyses were performed for more restrictive definitions of the subgroup changing from prior standard nasal steroids.
RESULTS


Of 482 total subjects, 218 (45.2%) reported using standard nasal steroid sprays at entry (mean duration, 1051 days). Across multiple outcome measures, improvements for ""switchers"" receiving EDS-FLU (least squares mean change from baseline vs EDS plus placebo) were comparable with improvements in the overall population. For EDS-FLU 372 μg, comparable improvements were observed in congestion (-0.73 vs -0.62), rhinorrhea (-0.71 vs -0.57), facial pain/pressure (-0.48 vs -0.41), and sense of smell (-0.35 vs -0.30) at week 4 and 22-item Sino-Nasal Outcome Test (-21.01 vs -20.52), Patient Global Impression of Change, and other outcomes at week 16. Results for EDS-FLU 186 μg were similar.
CONCLUSION


EDS-FLU comparably improves symptoms, irrespective of whether patients are symptomatic while using conventional nasal steroids before treatment.",2020,"For EDS-FLU 372 μg, comparable improvements were observed in congestion (-0.73 vs -0.62), rhinorrhea (-0.71 vs -0.57), facial pain/pressure (","['patients who remain symptomatic on standard nasal steroid sprays', 'Of\xa0482 total subjects, 218 (45.2%) reported using standard nasal steroid sprays at entry (mean duration, 1051 days', 'chronic rhinosinusitis (CRS', 'patients who have previously failed nasal steroids']","['conventional nasal steroid', 'fluticasone (EDS-FLU', 'fluticasone']","['facial pain/pressure ', 'sense of smell', 'congestion', 'switchers"" receiving EDS-FLU', 'rhinorrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0450319', 'cui_str': '1051'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}]","[{'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0700148', 'cui_str': 'Congestion'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}]",,0.0951543,"For EDS-FLU 372 μg, comparable improvements were observed in congestion (-0.73 vs -0.62), rhinorrhea (-0.71 vs -0.57), facial pain/pressure (","[{'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Senior', 'Affiliation': 'Division of Rhinology, Allergy, and Skull Base Surgery, Department of Otolaryngology-Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Rodney J', 'Initials': 'RJ', 'LastName': 'Schlosser', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bosso', 'Affiliation': 'Division of Rhinology, Department of Otorhinolaryngology-Head and Neck Surgery, Perelman Center for Advanced Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Soler', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC.'}]",International forum of allergy & rhinology,['10.1002/alr.22693']
2648,32970396,Dapagliflozin in Patients with Chronic Kidney Disease.,"BACKGROUND


Patients with chronic kidney disease have a high risk of adverse kidney and cardiovascular outcomes. The effect of dapagliflozin in patients with chronic kidney disease, with or without type 2 diabetes, is not known.
METHODS


We randomly assigned 4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m 2  of body-surface area and a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin (10 mg once daily) or placebo. The primary outcome was a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes.
RESULTS


The independent data monitoring committee recommended stopping the trial because of efficacy. Over a median of 2.4 years, a primary outcome event occurred in 197 of 2152 participants (9.2%) in the dapagliflozin group and 312 of 2152 participants (14.5%) in the placebo group (hazard ratio, 0.61; 95% confidence interval [CI], 0.51 to 0.72; P<0.001; number needed to treat to prevent one primary outcome event, 19 [95% CI, 15 to 27]). The hazard ratio for the composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal causes was 0.56 (95% CI, 0.45 to 0.68; P<0.001), and the hazard ratio for the composite of death from cardiovascular causes or hospitalization for heart failure was 0.71 (95% CI, 0.55 to 0.92; P = 0.009). Death occurred in 101 participants (4.7%) in the dapagliflozin group and 146 participants (6.8%) in the placebo group (hazard ratio, 0.69; 95% CI, 0.53 to 0.88; P = 0.004). The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes. The known safety profile of dapagliflozin was confirmed.
CONCLUSIONS


Among patients with chronic kidney disease, regardless of the presence or absence of diabetes, the risk of a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes was significantly lower with dapagliflozin than with placebo. (Funded by AstraZeneca; DAPA-CKD ClinicalTrials.gov number, NCT03036150.).",2020,The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes.,"['patients with chronic kidney disease, with or without type 2 diabetes', 'Patients with chronic kidney disease', 'participants with type 2 diabetes and in those without type 2 diabetes', 'patients with chronic kidney disease', '4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m 2  of body-surface area and a', 'Patients with Chronic Kidney Disease']","['placebo', 'urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin', 'Dapagliflozin', 'dapagliflozin']","['composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes', 'stage kidney disease, or death from renal causes', 'hazard ratio for the composite of death from cardiovascular causes or hospitalization for heart failure', 'Death', 'death from renal or cardiovascular causes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",4304.0,0.730754,The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes.,"[{'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefánsson', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Fan-Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Roberto D', 'Initials': 'RD', 'LastName': 'Toto', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'From the Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (H.J.L.H.); the George Institute for Global Health, Sydney (H.J.L.H., D.C.W.); Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden (B.V.S., M.L., C.D.S., A.-M.L.); the National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City (R.C.-R.); the Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA (G.M.C.); the Study Design and Biostatistics Center, University of Utah Health Sciences, Salt Lake City (T.G.); the Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China (F.-F.H.); KfH Kidney Center, Munich, and Department of Medicine 4, University of Erlangen-Nuremberg, Erlangen - both in Germany (J.F.E.M.); the Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow (J.J.V.M.), and the Department of Renal Medicine, University College London, London (D.C.W.) - both in the United Kingdom; Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the Department of Internal Medicine, UT Southwestern Medical Center, Dallas (R.D.T.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2024816']
2649,32966290,"Efficacy and safety of praziquantel and dihydroartemisinin piperaquine combination for treatment and control of intestinal schistosomiasis: A randomized, non-inferiority clinical trial.","BACKGROUND


Despite the reported success in reducing morbidity, praziquantel alone is insufficient for the control and elimination of schistosomiasis, partly due to its poor efficacy against the juvenile worms. Artemisinin derivatives are effective against juvenile worms but are less effective against adult worms. We compared the safety and efficacy of praziquantel and Dihydroartemisinin-piperaquine combination against the standard praziquantel alone for treatment of intestinal schistosomiasis.
METHODS


In this randomized, open-label, non-inferiority trial, 639 Schistosoma mansoni infected children were enrolled and randomized to receive either praziquantel alone or praziquantel plus Dihydroartemisinin-piperaquine combination. Two stool samples were collected on consecutive days at baseline, 3 and 8 weeks post-treatment and analyzed using thick smear Kato Katz method. Efficacy was assessed by cure and egg reduction rates at 3 and 8 weeks post-treatment. Adverse events were assessed within four hours of drugs intake. The primary outcome was cure rates at 8 weeks of post-treatment. Secondary outcomes were egg reduction rates at 8 weeks of post-treatment and treatment-associated adverse events.
RESULTS


At 3 weeks of post-treatment, cure rates were 88.3% (263/298, 95% CI = 84.1%- 91.4%) and 81.2% (277/341, 95% CI = 76.7%- 85.0%) for the combination therapy and praziquantel alone, respectively (p < 0.01, odds ratio (OR) = 1.74, 95% CI of OR = 1.11 to 2.69). At 8 weeks, there was a significant drop in the cure rates in praziquantel alone group to 63.9% (218/341, 95% CI = 58.7%- 68.8%) compared to 81.9% (244/298, 95% CI = 77.1%- 85.8%) in the combination therapy group (p < 0.0001, OR = 2.55, 95%CI of OR = 1.75 to 3.69). Egg reduction rates at 8 weeks post-treatment were significantly higher in the combination therapy group 93.6% (95% CI = 90.8%- 96.4%) compared to 87.9% (95% CI = 84.4%- 91.4%) in the praziquantel only group (p = 0.01). On both Univariate and Multivariate regression analysis, type of treatment received was a significant predictor of cure at week 8 post-treatment. Overall, 30.8% (95% CI = 27.2%- 34.4%) of the study participants experienced mild and transient treatment-associated adverse events, post-treatment abdominal pain (27.1%) being the most common adverse event observed. There was no significant difference in the overall occurrence of adverse events between the two treatment groups.
CONCLUSION


Praziquantel and Dihydroartemisinin piperaquine combination therapy is safe, and more efficacious compared to praziquantel alone for the treatment of intestinal schistosomiasis. Further studies are needed to explore if the combination therapy can be considered as an option for mass drug administration to control and eventually eliminate schistosomiasis.",2020,Egg reduction rates at 8 weeks post-treatment were significantly higher in the combination therapy group 93.6% (95% CI = 90.8%- 96.4%) compared to 87.9% (95% CI = 84.4%- 91.4%) in the praziquantel only group (p = 0.01).,"['639 Schistosoma mansoni infected children', 'intestinal schistosomiasis']","['praziquantel and dihydroartemisinin piperaquine combination', 'praziquantel alone or praziquantel plus Dihydroartemisinin-piperaquine combination', 'Praziquantel and Dihydroartemisinin piperaquine combination therapy', 'praziquantel and Dihydroartemisinin-piperaquine combination']","['mild and transient treatment-associated adverse events, post-treatment abdominal pain', 'Egg reduction rates', 'egg reduction rates at 8 weeks of post-treatment and treatment-associated adverse events', 'overall occurrence of adverse events', 'Adverse events', 'safety and efficacy', 'Efficacy and safety', 'Efficacy', 'cure rates', 'cure and egg reduction rates']","[{'cui': 'C0036319', 'cui_str': 'Schistosoma mansoni'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242497', 'cui_str': 'Intestinal schistosomiasis'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",639.0,0.259822,Egg reduction rates at 8 weeks post-treatment were significantly higher in the combination therapy group 93.6% (95% CI = 90.8%- 96.4%) compared to 87.9% (95% CI = 84.4%- 91.4%) in the praziquantel only group (p = 0.01).,"[{'ForeName': 'Rajabu Hussein', 'Initials': 'RH', 'LastName': 'Mnkugwe', 'Affiliation': 'Department of Clinical Pharmacology, School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Omary', 'Initials': 'O', 'LastName': 'Minzi', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Safari', 'Initials': 'S', 'LastName': ""Kinung'hi"", 'Affiliation': 'National Institute for Medical Research (NIMR), Mwanza Research Centre, Mwanza, Tanzania.'}, {'ForeName': 'Appolinary', 'Initials': 'A', 'LastName': 'Kamuhabwa', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Aklillu', 'Affiliation': 'Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska University Hospital-Huddinge, Karolinska Institutet, Stockholm, Sweden.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008619']
2650,32966293,Novel dual HIV maintenance therapy with nevirapine plus lamivudine retain viral suppression through 144 weeks-A proof-of-concept study.,"OBJECTIVES


The aim of this proof-of-concept study is to test feasibility and efficacy of NVP plus Lamivudine (3TC) as novel simplified HIV maintenance dual therapy (DT) strategy.
METHODS


Patients under combined antiretroviral treatment (cART) with fully suppressed HIV plasma viral load (pVL) >24 months-whereof >6 months on an NVP- containing regimen-were switched to oral NVP plus 3TC for 24 weeks. Patients could then decide whether to continue DT or return to the previous cART. HIV pVL was monitored monthly until week 144. The primary outcome was confirmed viral failure (RNA >100 copies/ml). Low-level detection of HIV-RNA in plasma was compared in each patient with pre-study viral load measurements.
RESULTS


Twenty patients were included, switched to DT and all completed week 24. One patient decided thereafter to discontinue study participation for personal reasons. After a total of 144 observation weeks, none of the patients failed. The frequency of low- level HIV-RNA detection was not different from the period before randomization.
CONCLUSIONS


Our findings are surprising but given the nature of a proof-of-concept study, the results do not support the use of this dual regimen. However, as this dual HIV maintenance strategy was feasible and effective, over a period of 144 weeks, we suggest NVP plus 3TC warrants further evaluation as potential maintenance option in patients tolerating nevirapine. A properly sized multicentre non-inferiority trial is ongoing to further evaluate the value of this DT maintenance strategy.",2020,"The frequency of low- level HIV-RNA detection was not different from the period before randomization.
","['Patients under combined antiretroviral treatment (cART) with fully suppressed HIV plasma viral load ', 'patients tolerating nevirapine', 'Twenty patients were included, switched to DT and all completed week 24']","['NVP plus Lamivudine (3TC', 'oral NVP plus 3TC', 'nevirapine plus lamivudine']","['viral failure', 'HIV pVL', 'frequency of low- level HIV-RNA detection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",20.0,0.0637505,"The frequency of low- level HIV-RNA detection was not different from the period before randomization.
","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Kahlert', 'Affiliation': 'Infectious Diseases and Hospital Epidemiology, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cipriani', 'Affiliation': 'Infectious Diseases and Hospital Epidemiology, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vernazza', 'Affiliation': 'Infectious Diseases and Hospital Epidemiology, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}]",PloS one,['10.1371/journal.pone.0237770']
2651,32966294,"The effects of poloxamer and sodium alginate mixture (Guardix-SG®) on range of motion after axillary lymph node dissection: A single-center, prospective, randomized, double-blind pilot study.","PURPOSE


Restricted shoulder mobility is a major upper extremity dysfunction associated with lower quality of life and disability after breast cancer surgery. We hypothesized that a poloxamer and sodium alginate mixture (Guardix-SG®) applied after axillary lymph node dissection (ALND) would significantly improve shoulder range of motion (ROM) in patients with breast cancer.
METHODS


We conducted a double-blind, randomized, prospective study to evaluate the clinical efficacy and safety of Guardix-SG® for the prevention of upper extremity dysfunction after ALND. The primary outcome measure was shoulder ROM at baseline (T0) and 3 (T1), 6 (T2), and 12 months (T3) after surgery. Secondary outcome measures were the Disabilities of the Arm, Shoulder, and Hand score(DASH), pain associated with movement, which was assessed using a numeric rating scale, and lymphedema assessed using body composition analyzer.
RESULTS


A total of 83 women with breast cancer were randomly assigned to either the Guardix-SG® group or the control group. In the Guardix-SG® group (n = 37), Guardix-SG® was applied to the axillary region after ALND. In the control group (n = 46), ALND was performed without using Guardix-SG®. Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182). No adverse effect was observed in either group.
CONCLUSIONS


The results of this study have shown that Guardix-SG® help improve shoulder ROM without causing adverse effects in patients who underwent breast cancer surgery. However, there was no statistically significant difference from the control group. A further large-scale study is needed to obtain a more conclusive conclusion.
TRIAL REGISTRATION


CRISKCT0003386; https://cris.nih.go.kr (20181207).",2020,"Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182).","['83 women with breast cancer', 'upper extremity dysfunction after ALND', 'breast cancer surgery', 'patients who underwent breast cancer surgery', 'patients with breast cancer']","['poloxamer and sodium alginate mixture (Guardix-SG®', 'Guardix-SG®']","['Disabilities of the Arm, Shoulder, and Hand score(DASH), pain associated with movement, which was assessed using a numeric rating scale, and lymphedema assessed using body composition analyzer', 'adverse effect', 'shoulder ROM', 'shoulder range of motion (ROM', 'shoulder ROM at baseline (T0) and 3 (T1), 6 (T2']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1698635', 'cui_str': 'Upper extremity dysfunction'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600615', 'cui_str': 'Poloxamer'}, {'cui': 'C0142791', 'cui_str': 'Sodium alginate'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C3852262', 'cui_str': 'guardix'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",83.0,0.183932,"Comparing ROM for shoulder flexion before surgery (178.2°) and 12 months after surgery (172.3°), that was restored 12 months after surgery in the Guardix-SG® group, and there was no statistically significant difference between that at before surgery and 12 months after surgery (p = 0.182).","[{'ForeName': 'Sae Byul', 'Initials': 'SB', 'LastName': 'Lee', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Sung-Chan', 'Initials': 'SC', 'LastName': 'Gwark', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Cheol Min', 'Initials': 'CM', 'LastName': 'Kang', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Guiyun', 'Initials': 'G', 'LastName': 'Sohn', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jisun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Il Yong', 'Initials': 'IY', 'LastName': 'Chung', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jong Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Hee Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Beom Seok', 'Initials': 'BS', 'LastName': 'Ko', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Sei-Hyun', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Junghwa', 'Initials': 'J', 'LastName': 'Do', 'Affiliation': 'Department of Rehabilitation Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jae Yong', 'Initials': 'JY', 'LastName': 'Jeon', 'Affiliation': 'Department of Rehabilitation Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jinsung', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Ulsan University Hospital, Ulsan, Korea.'}, {'ForeName': 'Eunhae', 'Initials': 'E', 'LastName': 'Um', 'Affiliation': 'Department of Surgery, Inje University Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Tae In', 'Initials': 'TI', 'LastName': 'Yoon', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Dongnam institute of Radiological and medical science, Busan, Korea.'}, {'ForeName': 'Sung-Ui', 'Initials': 'SU', 'LastName': 'Jung', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Kosin University Gospel Hospital, Busan, Korea.'}, {'ForeName': 'Minkyu', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Byung Ho', 'Initials': 'BH', 'LastName': 'Son', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0238284']
2652,32966320,Comparison of hypobaric hypoxia symptoms between a recalled exposure and a current exposure.,"BACKGROUND


Aircrew members are required to attend hypoxia awareness training regularly to strengthen their memory of their personal hypoxia symptoms by undergoing training inside a hypobaric chamber. The aim of this study was to examine the association between hypoxia symptoms experienced during two training sessions that were 4 years apart.
METHODS


This was a crossover study to compare hypoxia symptoms and self-reported physiological effects of trapped gas between a previous training session and a current training session in an altitude chamber. The subjects were military crew members who undertook a 25,000-feet refresher training course in 2018. We used a structured questionnaire to obtain the target information before and during hypoxia exposure. Data were analyzed using SPSS software.
RESULTS


A total of 341 trainees participated in this survey and completely filled out the questionnaire. Gastrointestinal tract discomfort caused by the expansion of trapped gas was the main physiological reaction during the previous and current training sessions. Frequently reported symptoms were poor concentration (30.5%), impaired cognitive function (20.5%), visual disturbances (16.4%), hot flashes (15.8%), and paresthesia (12.6%) during both exposures. However, the proportions of participants reporting poor concentration (P = 0.378) and visual disturbances (P = 0.594) were not significantly different between the recalled and current training sessions. The five most common symptoms among the subjects with less than 1,000 flight hours were poor concentration (29.8%), visual disturbance (27.3%), impaired cognitive function (14.9%), dizziness/lightheadedness (11.6%), and hot flashes (9.9%), which overlapped substantially with the symptoms reported by other subjects. The occurrence of those five most common symptoms in the group with more than 1,000 flight hours did not significantly differ between the recalled training session and the current training session.
CONCLUSIONS


The most common hypoxia symptoms reported were similar between the recalled and current training sessions in an environment with a low oxygen concentration. This finding was also clearly affected by the duration of flight experience. Moreover, GI effects of the expansion of trapped gas were commonly observed at low atmospheric pressure.",2020,Gastrointestinal tract discomfort caused by the expansion of trapped gas was the main physiological reaction during the previous and current training sessions.,"['341 trainees participated in this survey and completely filled out the questionnaire', 'subjects were military crew members who undertook a 25,000-feet refresher training course in 2018']",[],"['visual disturbances', 'hot flashes', 'paresthesia', 'dizziness/lightheadedness', 'Gastrointestinal tract discomfort', 'visual disturbance', 'impaired cognitive function']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]",[],"[{'cui': 'C0547030', 'cui_str': 'Visual disturbance'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",341.0,0.0192821,Gastrointestinal tract discomfort caused by the expansion of trapped gas was the main physiological reaction during the previous and current training sessions.,"[{'ForeName': 'Min-Yu', 'Initials': 'MY', 'LastName': 'Tu', 'Affiliation': 'Aviation Physiology Research Laboratory, Kaohsiung Armed Forces General Hospital Gangshan Branch, Kaohsiung City, Taiwan.'}, {'ForeName': 'Kwo-Tsao', 'Initials': 'KT', 'LastName': 'Chiang', 'Affiliation': 'Aviation Physiology Research Laboratory, Kaohsiung Armed Forces General Hospital Gangshan Branch, Kaohsiung City, Taiwan.'}, {'ForeName': 'Chao-Chien', 'Initials': 'CC', 'LastName': 'Cheng', 'Affiliation': 'Aviation Physiology Research Laboratory, Kaohsiung Armed Forces General Hospital Gangshan Branch, Kaohsiung City, Taiwan.'}, {'ForeName': 'Fang-Ling', 'Initials': 'FL', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital Beitou Branch, National Defense Medical Center, Taipei City, Taiwan.'}, {'ForeName': 'Yu-His', 'Initials': 'YH', 'LastName': 'Wen', 'Affiliation': 'Aviation Physiology Research Laboratory, Kaohsiung Armed Forces General Hospital Gangshan Branch, Kaohsiung City, Taiwan.'}, {'ForeName': 'Sing-Hong', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Aviation Physiology Research Laboratory, Kaohsiung Armed Forces General Hospital Gangshan Branch, Kaohsiung City, Taiwan.'}, {'ForeName': 'Chung-Yu', 'Initials': 'CY', 'LastName': 'Lai', 'Affiliation': 'Graduate Institute of Aerospace and Undersea Medicine, National Defense Medical Center, Taipei City, Taiwan.'}]",PloS one,['10.1371/journal.pone.0239194']
2653,32842112,Comparison of Neurocognitive Outcomes in Postoperative Adolescents with Unilateral Coronal Synostosis.,"Unilateral coronal nonsyndromic craniosynostosis is associated with asymmetric skull growth, which may influence cerebral long-term function. Twenty affected adolescents who underwent cranial vault remodeling at a mean age of 8.2 months (12 from the Yale Craniofacial Clinic and eight from the Children's Hospital of Philadelphia) all completed a double-blinded neurodevelopmental assessment at an average age of 12.1 years. The study cohort included 55 percent female and 50 percent right-sided craniosynostosis. Mean verbal intelligence quotient was highest at 117.3, and mean performance intelligence quotient was 106.4, for a mean full-scale intelligence quotient of 112.5. Patients performed above the national average on all academic achievements except for numerical operations, which was significantly lower than word reading (p = 0.022). Patients performed below average on all Beery-Buktenica visual motor tests; motor-coordination was poorer than both visual motor integration and visual perception (p = 0.027 and p = 0.005). Significant positive correlations existed between paternal education/visual perception (r = 0.450; p = 0.046) and household income/verbal intelligence quotient (r = 0.628; p = 0.004). Patients with right unilateral coronal nonsyndromic craniosynostosis had improved spelling compared with left-sided patients on multivariate regression (p = 0.033). Female patients had higher motor coordination (p = 0.024). Breast-fed patients had better performance intelligence quotient (p = 0.024), visual motor integration (p = 0.014), and visual perception (p = 0.031). Adolescents who underwent cranial vault remodeling at two institutions had above average intelligence quotient scores, but worse mathematical and visual motor achievement compared with control subjects. Left-side craniosynostosis patients performed worse in spelling than right-side patients. Breast-feeding was an independent predictor for improved performance intelligence quotient, visual motor achievement, and visual perception performance. Study findings are limited by the cohort size. A larger population study is required, which could validate or modify the study conclusions.",2020,"Breast-fed patients had better performance intelligence quotient (p = 0.024), visual motor integration (p = 0.014), and visual perception (p = 0.031).","['55 percent female and 50 percent right-sided craniosynostosis', 'Postoperative Adolescents with Unilateral Coronal Synostosis', ""Twenty affected adolescents who underwent cranial vault remodeling at a mean age of 8.2 months (12 from the Yale Craniofacial Clinic and eight from the Children's Hospital of Philadelphia) all completed a double-blinded neurodevelopmental assessment at an average age of 12.1 years""]",[],"['mean performance intelligence quotient', 'worse mathematical and visual motor achievement', 'household income/verbal intelligence quotient', 'Mean verbal intelligence quotient', 'paternal education/visual perception', 'visual perception', 'visual motor integration and visual perception', 'performance intelligence quotient, visual motor achievement, and visual perception performance', 'performance intelligence quotient', 'visual motor integration', 'higher motor coordination']","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2931150', 'cui_str': 'Unilateral Coronal Synostosis'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0205950', 'cui_str': 'Structure of vault of skull'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582578', 'cui_str': 'Performance intelligence quotient'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0582577', 'cui_str': 'Verbal intelligence quotient'}, {'cui': 'C0337493', 'cui_str': 'Paternal'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",20.0,0.037582,"Breast-fed patients had better performance intelligence quotient (p = 0.024), visual motor integration (p = 0.014), and visual perception (p = 0.031).","[{'ForeName': 'Robin T', 'Initials': 'RT', 'LastName': 'Wu', 'Affiliation': 'New Haven, Conn.; and Philadelphia, Pa. From the Section of Plastic and Reconstructive Surgery, Department of Surgery, and the Yale Child Study Center, Yale University School of Medicine; and the Division of Plastic Surgery, Department of Surgery, Perelman School of Medicine at the University of Pennsylvania.'}, {'ForeName': 'Kyle S', 'Initials': 'KS', 'LastName': 'Gabrick', 'Affiliation': ''}, {'ForeName': 'Anusha', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Landi', 'Affiliation': ''}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Bartlett', 'Affiliation': ''}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Persing', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Alperovich', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007067']
2654,32885455,Impact of MnSOD and GPx1 Genotype at Different Levels of Enteral Nutrition Exposure on Oxidative Stress and Mortality: A Post hoc Analysis From the FeDOx Trial.,"BACKGROUND


Converting nutrition support to energy results in mitochondrial free radical production, possibly increasing oxidative stress. Highly prevalent single nucleotide variants (SNV) exist for the genes encoding antioxidant enzymes responsible for the detoxification of reactive oxygen species. Our objective was to explore the interaction between nutrition support and genetic SNV's for two anti-oxidant proteins (rs4880 SNV for manganese superoxide dismutase and rs1050450 SNV for glutathione peroxidase 1) on oxidative stress and secondarily on intensive care unit (ICU) mortality.
METHODS


We performed a post-hoc analysis on 34 mechanically ventilated sepsis patients from a randomized control feeding trial. Participants were dichotomized into those who carried both the rs4880 and the rs1050450 at-risk alleles (Risk Group) versus all others (Nonrisk Group). We explored the interaction between genotype and percent time spent in the upper median of energy exposure on oxidative stress and ICU mortality.
RESULTS


Adjusting for confounders, the slope of log F2-isoprostane levels across percentage of days spent in the upper median of daily kilocalories per kilogram (kcal/kg) was 0.01 higher in the Risk Group compared to the Non-Risk Group (p=0.01). Every 1 percent increase in days spent in the upper median of daily kcal/kg was associated with an adjusted 10.3 percent increased odds of ICU mortality amongst participants in the Risk Group (odds ratio [OR]=1.103, p=0.06) but was highly insignificant in the Nonrisk group (OR=0.991, P=0.79).
CONCLUSION


Nutrition support may lead to increased oxidative stress and worse clinical outcomes in a large percent of ICU patients with an at-risk genotype.",2020,Highly prevalent single nucleotide variants (SNV) exist for the genes encoding antioxidant enzymes responsible for the detoxification of reactive oxygen species.,"['34 mechanically ventilated sepsis patients', 'Participants were dichotomized into those who carried both the rs4880 and the rs1050450 at-risk alleles (Risk Group) versus all others (Nonrisk Group']",[],"['Oxidative Stress and Mortality', 'oxidative stress', 'slope of log F2-isoprostane levels', 'ICU mortality']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0949861', 'cui_str': 'F2-Isoprostane'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",34.0,0.165438,Highly prevalent single nucleotide variants (SNV) exist for the genes encoding antioxidant enzymes responsible for the detoxification of reactive oxygen species.,"[{'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'McKeever', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Peterson', 'Affiliation': 'Department of Clinical Nutrition, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Lateef', 'Affiliation': 'Department of Clinical Nutrition, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Freels', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Diamond', 'Affiliation': 'Department of Pathology, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Braunschweig', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, Illinois, USA.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.2012']
2655,32589775,"Safety, Tolerability, and Pharmacokinetics of Remdesivir, An Antiviral for Treatment of COVID-19, in Healthy Subjects.","Remdesivir (RDV), a single diastereomeric monophosphoramidate prodrug that inhibits viral RNA polymerases, has potent in vitro antiviral activity against severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). RDV received the US Food and Drug Administration (FDA)'s emergency use authorization in the United States and approval in Japan for treatment of patients with severe coronavirus disease 2019 (COVID-19). This report describes two phase I studies that evaluated the safety and pharmacokinetics (PKs) of single escalating and multiple i.v. doses of RDV (solution or lyophilized formulation) in healthy subjects. Lyophilized formulation was evaluated for potential future use in clinical trials due to its storage stability in resource-limited settings. All adverse events were grade 1 or 2 in severity. Overall, RDV exhibited a linear profile following single-dose i.v. administration over 2 hours of RDV solution formulation across the dose range of 3-225 mg. Both lyophilized and solution formulations provided comparable PK parameters. High intracellular concentrations of the active triphosphate (~ 220-fold to 370-fold higher than the in vitro half-maximal effective concentration against SARS-CoV-2 clinical isolate) were achieved following infusion of 75 mg or 150 mg lyophilized formulation over 30 minutes or 2 hours. Following multiple-doses of RDV 150 mg once daily for 7 or 14 days, RDV exhibited a PK profile similar to single-dose administration. Metabolite GS-441524 accumulated ~ 1.9-fold after daily dosing. Overall, RDV exhibited favorable safety and PK profiles that supported once-daily dosing.",2020,"Following multiple-doses of RDV 150 mg once daily for 7 or 14 days, RDV exhibited a PK profile similar to single-dose administration.","['patients with severe coronavirus disease 2019 (COVID-19', 'healthy subjects', 'Healthy Subjects']","['RDV (solution or lyophilized formulation', 'RDV']","['safety and pharmacokinetics (PKs', 'Metabolite GS-441524', 'High intracellular concentrations of the active triphosphate', 'Safety, Tolerability, and Pharmacokinetics of Remdesivir']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0077289', 'cui_str': 'tris(chloroethyl)phosphate'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}]",,0.0892101,"Following multiple-doses of RDV 150 mg once daily for 7 or 14 days, RDV exhibited a PK profile similar to single-dose administration.","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Humeniuk', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Mathias', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Huyen', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Gong', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Chng', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Vu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'German', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}]",Clinical and translational science,['10.1111/cts.12840']
2656,31378553,Examination of heterogeneity in treatment response to antipsychotic medications.,,2019,,[],[],[],[],[],[],,0.0220531,,"[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bareis', 'Affiliation': 'Division of Behavioral Health Services and Policy Research, Department of Psychiatry, Columbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA. Electronic address: natalie.bareis@nyspi.columbia.edu.'}, {'ForeName': 'T Scott', 'Initials': 'TS', 'LastName': 'Stroup', 'Affiliation': 'Division of Behavioral Health Services and Policy Research, Department of Psychiatry, Columbia University and the New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA. Electronic address: scott.stroup@nyspi.columbia.edu.'}]",Schizophrenia research,['10.1016/j.schres.2019.07.033']
2657,31378555,Impact of first episode psychosis treatment on heavy cannabis use: Secondary analysis on RAISE-ETP study.,,2019,,[],[],[],[],[],[],,0.020132,,"[{'ForeName': 'Karl C', 'Initials': 'KC', 'LastName': 'Alcover', 'Affiliation': 'Behavioral Health Innovations, Washington State University, Spokane, WA, United States of America.'}, {'ForeName': 'Oladunni', 'Initials': 'O', 'LastName': 'Oluwoye', 'Affiliation': 'Behavioral Health Innovations, Washington State University, Spokane, WA, United States of America; Department of Medical Education and Clinical Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, United States of America. Electronic address: Oladunni.oluwoye@wsu.edu.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Kriegel', 'Affiliation': 'Behavioral Health Innovations, Washington State University, Spokane, WA, United States of America.'}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'McPherson', 'Affiliation': 'Department of Medical Education and Clinical Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, United States of America; Providence Medical Research Center, Providence Health Care, Spokane, WA, United States of America.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McDonell', 'Affiliation': 'Behavioral Health Innovations, Washington State University, Spokane, WA, United States of America; Department of Medical Education and Clinical Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2019.07.014']
2658,32963028,SARS-CoV-2 organising pneumonia: 'Has there been a widespread failure to identify and treat this prevalent condition in COVID-19?',"Reviews of COVID-19 CT imaging along with postmortem lung biopsies and autopsies indicate that the majority of patients with COVID-19 pulmonary involvement have secondary organising pneumonia (OP) or its histological variant, acute fibrinous and organising pneumonia, both well-known complications of viral infections. Further, many publications on COVID-19 have debated the puzzling clinical characteristics of 'silent hypoxemia', 'happy hypoxemics' and 'atypical ARDS', all features consistent with OP. The recent announcement that RECOVERY, a randomised controlled trial comparing dexamethasone to placebo in COVID-19, was terminated early due to excess deaths in the control group further suggests patients present with OP given that corticosteroid therapy is the first-line treatment. Although RECOVERY along with other cohort studies report positive effects with corticosteroids on morbidity and mortality of COVID-19, treatment approaches could be made more effective given that secondary OP often requires prolonged duration and/or careful and monitored tapering of corticosteroid dose, with 'pulse' doses needed for the well-described fulminant subtype. Increasing recognition of this diagnosis will thus lead to more appropriate and effective treatment strategies in COVID-19, which may lead to a further reduction of need for ventilatory support and improved survival.",2020,"Increasing recognition of this diagnosis will thus lead to more appropriate and effective treatment strategies in COVID-19, which may lead to a further reduction of need for ventilatory support and improved survival.",[],"['dexamethasone', 'COVID-19 CT imaging', 'placebo', 'corticosteroids']",[],[],"[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.102187,"Increasing recognition of this diagnosis will thus lead to more appropriate and effective treatment strategies in COVID-19, which may lead to a further reduction of need for ventilatory support and improved survival.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Kory', 'Affiliation': ""Advocate Aurora Critical Care Service, Aurora St Luke's Medical Center, Milwaukee, Wisconsin, USA pierrekory@icloud.com.""}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Kanne', 'Affiliation': 'School of Medicine and Public Health, University of Wisconsin-Madison, Madison, Wisconsin, USA.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000724']
2659,32963047,"A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis.","OBJECTIVES


Recent advances in systemic sclerosis (SSc) show that it involves a T-helper type-2-oriented immune response with interleukin (IL)-4 and IL-13. Romilkimab is an engineered, humanised, bispecific immunoglobulin-G4 antibody that binds and neutralises IL-4/IL-13 making it ideal for exploration in fibrosis.
METHODS


Patients aged ≥18 years diagnosed with diffuse cutaneous SSc (dcSSc), and with or without immunosuppressive background therapy, were randomised (1:1) to subcutaneous romilkimab 200 mg or placebo one time per week for 24 weeks in this double-blind, proof-of-concept, phase II study. The primary endpoint was change in modified Rodnan skin score (mRSS) from baseline to week 24.
RESULTS


Ninety-seven patients were randomised to romilkimab (n=48) or placebo (n=49) for 24 weeks. Least-squares mean (SE) change in mRSS was -4.76 (0.86) for romilkimab versus -2.45 (0.85) for placebo yielding a mean (SE) (90% CI) difference of -2.31 (1.21) (-4.32 to -0.31; p=0.0291, one-sided). Treatment-emergent AEs were balanced between placebo (n=41; 84%) and romilkimab (n=40; 80%). Most were mild-to-moderate and discontinuations were low (three overall). There were two deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo)), neither were considered treatment related. Two patients in the placebo group had a cardiovascular treatment-emergent SAE (one cardiac failure, one cardiomyopathy), but there were no cardiac safety signals with romilkimab.
CONCLUSION


This study demonstrated significant effects on skin changes with romilkimab in early dcSSc that require confirmation with a longer and more comprehensive phase III study to determine clinical relevance.
TRIAL REGISTRATION NUMBER


NCT02921971.",2020,"There were two deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo)), neither were considered treatment related.","['early diffuse cutaneous systemic sclerosis', 'Patients aged ≥18 years diagnosed with diffuse cutaneous SSc (dcSSc), and with or without immunosuppressive background therapy', 'Ninety-seven patients']","['romilkimab (SAR156597', 'placebo', 'subcutaneous romilkimab 200\u2009mg or placebo', 'romilkimab']","['cardiovascular treatment-emergent SAE (one cardiac failure, one cardiomyopathy', 'deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo', 'modified Rodnan skin score (mRSS', 'Least-squares mean (SE) change in mRSS']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439073', 'cui_str': '97'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1262147', 'cui_str': 'Scleroderma renal crisis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",97.0,0.626656,"There were two deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo)), neither were considered treatment related.","[{'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Paris Descartes University, Paris, France yannick.allanore@cch.aphp.fr.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wung', 'Affiliation': 'Sanofi R&D, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Soubrane', 'Affiliation': 'Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Esperet', 'Affiliation': 'Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Marrache', 'Affiliation': 'Immunology and Inflammation, Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Bejuit', 'Affiliation': 'Statistics and Programming, Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Lahmar', 'Affiliation': 'Global Safety, Sanofi R&D, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Rheumatology Clinic, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'Centre for Rheumatology and and Connective Tissue Diseases, University College London Division of Medicine, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218447']
2660,32963461,Dose-dense paclitaxel plus carboplatin  vs . epirubicin and cyclophosphamide with paclitaxel as adjuvant chemotherapy for high-risk triple-negative breast cancer.,"Objective


The objective of this open-label, randomized study was to compare dose-dense paclitaxel plus carboplatin (PCdd) with dose-dense epirubicin and cyclophosphamide followed by paclitaxel (ECdd-P) as an adjuvant chemotherapy for early triple-negative breast cancer (TNBC).
Methods


We included Chinese patients with high recurrence risk TNBC who underwent primary breast cancer surgery. They were randomly assigned to receive PCdd [paclitaxel 150 mg/m 2  on d 1 and carboplatin, the area under the curve, (AUC)=3 on d 2] or ECdd-P (epirubicin 80 mg/m 2  divided in 2 d and cyclophosphamide 600 mg/m 2  on d 1 for 4 cycles followed by paclitaxel 175 mg/m 2  on d 1 for 4 cycles) every 2 weeks with granulocyte colony-stimulating factor (G-CSF) support. The primary endpoint was 3-year disease-free survival (DFS); the secondary endpoints were overall survival (OS) and safety.
Results


The intent-to-treat population included 143 patients (70 in the PCdd arm and 73 in the ECdd-P arm). Compared with the ECdd-P arm, the PCdd arm had significantly higher 3-year DFS [93.9%  vs . 79.1%; hazard ratio (HR)=0.310; 95% confidence interval (95% CI), 0.137-0.704; log-rank, P=0.005] and OS (98.5%  vs . 92.9%; HR=0.142; 95% CI, 0.060-0.825; log-rank, P=0.028). Worse neutropenia (grade 3/4) was found in the ECdd-P than the PCdd arm (47.9%  vs . 21.4%, P=0.001).
Conclusions


PCdd was superior to ECdd-P as an adjuvant chemotherapy for early TNBC with respect to improving the 3-year DFS and OS. PCdd also yielded lower hematological toxicity. Thus, PCdd might be a preferred regimen for early TNBC patients with a high recurrence risk.",2020,Worse neutropenia (grade 3/4) was found in the ECdd-P than the PCdd arm (47.9%  vs .,"['early TNBC patients with a high recurrence risk', 'early triple-negative breast cancer (TNBC', 'high-risk triple-negative breast cancer', '143 patients (70 in the PCdd arm and 73 in the ECdd-P arm', 'Chinese patients with high recurrence risk TNBC who underwent primary breast cancer surgery']","['paclitaxel plus carboplatin', 'epirubicin and cyclophosphamide with paclitaxel', 'PCdd [paclitaxel 150 mg/m 2  on d 1 and carboplatin, the area under the curve, (AUC)=3 on d 2] or ECdd-P (epirubicin 80 mg/m 2  divided in 2 d and cyclophosphamide 600 mg/m 2  on d 1 for 4 cycles followed by paclitaxel 175 mg/m 2  on d 1 for 4 cycles) every 2 weeks with granulocyte colony-stimulating factor (G-CSF) support', 'paclitaxel plus carboplatin (PCdd) with dose-dense epirubicin and cyclophosphamide followed by paclitaxel (ECdd-P']","['Worse neutropenia', '3-year DFS', 'OS', 'overall survival (OS) and safety', 'hematological toxicity', '3-year disease-free survival (DFS', '3-year DFS and OS']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0071530', 'cui_str': 'Polychlorodibenzo-p-dioxin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0071530', 'cui_str': 'Polychlorodibenzo-p-dioxin'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.130849,Worse neutropenia (grade 3/4) was found in the ECdd-P than the PCdd arm (47.9%  vs .,"[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Mu', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Tongtong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.'}]",Chinese journal of cancer research = Chung-kuo yen cheng yen chiu,['10.21147/j.issn.1000-9604.2020.04.06']
2661,32963470,Interaction of Heavy Drinking Patterns and Depression Severity Predicts Efficacy of Quetiapine Fumarate XR in Lowering Alcohol Intake in Alcohol Use Disorder Patients.,"Background


Shared etiological pathways of dopamine and serotonin neurotransmission play a central role in heavy alcohol intake and exacerbation in the symptoms of depression.We investigated the treatment efficacy of Quetiapine fumarate extended release (XR) in lowering alcohol intake in alcohol use disorder (AUD) patients indicated by the shared alleviation of depression ratings and patterns of heavy drinking.
Methods


Hundred and eight male and female heavy drinking AUD patients in the age range of 18 to 64 years. participated in a randomized clinical trial (RCT) to receive 12 weeks of quetiapine XR or placebo (N = 115). Participants were sub-grouped by the severity grading of depression using Montgomery-Asberg Depression Rating Scale (MADRS) (clinically relevant ⩾8 [CR], clinically non-relevant ⩽7 [CNR]) at baseline in both the groups. Drinking history and depression ratings were assessed at the patients' visits.
Results


Heavy drinking days (HDD) and total drinks (TD) were significantly fewer in CR patients at the treatment end. A true positive response in AUROC analysis supported the lowering of TD in CR patients. The number of drinking days (NDD) and average drinks per drinking day (AvgD) were lower in the CNR patients at treatment-end. Significant associations with increasing effect sizes were observed for all the heavy drinking measures (HDD, TD, NDD, and AvgD) and MADRS scores by the end of the treatment course.
Conclusions


Baseline elevated depressive symptoms could likely predict the course of heavy alcohol drinking during the treatment, and efficacy outcome of a treatment. AUD patients with baseline clinically significant depression had a progressive lowering in heavy drinking markers significantly corresponding to the lowering of depression symptoms by the end of treatment with Quetiapine fumarate XR.ClinicalTrials.gov: NCT#0049862 (https://clinicaltrials.gov/ct2/show/NCT00498628?term=litten&draw=2&rank=3).",2020,Heavy drinking days (HDD) and total drinks (TD) were significantly fewer in CR patients at the treatment end.,"['Methods\n\n\nHundred and eight male and female heavy drinking AUD patients in the age range of 18 to 64 years', 'alcohol use disorder (AUD) patients', 'Alcohol Use Disorder Patients']","['Quetiapine fumarate extended release (XR', 'Quetiapine fumarate XR.ClinicalTrials.gov', 'quetiapine XR or placebo', 'Quetiapine Fumarate XR']","['Heavy drinking days (HDD) and total drinks (TD', 'Drinking history and depression ratings', 'depression symptoms', 'heavy drinking measures (HDD, TD, NDD, and AvgD) and MADRS scores', 'progressive lowering in heavy drinking markers', 'severity grading of depression using Montgomery-Asberg Depression Rating Scale (MADRS) (clinically relevant ⩾8 [CR], clinically non-relevant ⩽7 [CNR', 'number of drinking days (NDD) and average drinks per drinking day (AvgD']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0724680', 'cui_str': 'Quetiapine fumarate'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",8.0,0.0483862,Heavy drinking days (HDD) and total drinks (TD) were significantly fewer in CR patients at the treatment end.,"[{'ForeName': 'Vatsalya', 'Initials': 'V', 'LastName': 'Vatsalya', 'Affiliation': 'Department of Medicine, University of Louisville, Louisville, KY, USA.'}, {'ForeName': 'Maiying', 'Initials': 'M', 'LastName': 'Kong', 'Affiliation': 'Department of Biostatistics and Bioinformatics, University of Louisville, KY, USA.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Marsano', 'Affiliation': 'Department of Medicine, University of Louisville, Louisville, KY, USA.'}, {'ForeName': 'Zimple', 'Initials': 'Z', 'LastName': 'Kurlawala', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Louisville, KY, USA.'}, {'ForeName': 'Kan V', 'Initials': 'KV', 'LastName': 'Chandras', 'Affiliation': 'Fort Valley State University, Warner Robbins, GA, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism NIH, Bethesda, MD, USA.'}, {'ForeName': 'Vijay A', 'Initials': 'VA', 'LastName': 'Ramchandani', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism NIH, Bethesda, MD, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'McClain', 'Affiliation': 'Department of Medicine, University of Louisville, Louisville, KY, USA.'}]",Substance abuse : research and treatment,['10.1177/1178221820955185']
2662,32963522,"Effectiveness of Propofol versus Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Ear, Nose, and Throat Surgery in Tikur Anbessa Specialized Hospital and Yekatit 12th Hospital, Addis Ababa, Ethiopia.","Background


Postoperative nausea and vomiting (PONV) remain as common and unpleasant and highly distressful experience following ear, nose, and throat surgery. During ENT surgery, the incidence of PONV could be significantly reduced in patients who receive dexamethasone and propofol as prophylaxis. However, the comparative effectiveness of the two drugs has not been assessed. The aim of this study was to compare the effectiveness of propofol and dexamethasone for prevention of PONV in ear, nose, and throat surgery.
Methods


This study was conducted in 80 patients, with ASA I and II, aged 18-65 years, and scheduled for ENT surgery between December 20, 2017, and March 20, 2018. Patients were randomly assigned to Group A and Group B. Immediately after the procedure, Group A patients received single dose of intravenous (IV) dexamethasone (10 mg/kg) and Group B patients were given propofol (0.5 mg/kg, IV), and equal follow-up was employed. The incidence of PONV was noted at 6th, 12th, and 24th hour of drug administration. Independent  t -test and Mann-Whitney test were used for comparison of symmetric numerical and asymmetric data between groups, respectively. Categorical data were analyzed with the chi-square test, and  p  value of < 0.05 was considered as level of significance.
Results


The incidences of PONV throughout the 24-hour postoperative period were 35% in the propofol group and 25% in the dexamethasone group. Statistical significance was found in incidence of PONV (0% versus 22.5%) and use of antiemetic (0% versus 5%) between dexamethasone and propofol groups, respectively, at 12-24 hours. Over 24 hours, 5% in dexamethasone group and 12.5% in propofol group developed moderate PONV, while none of the participants felt severe PONV.
Conclusions


Dexamethasone was more effective than propofol to prevent PONV with lower requirements of rescue antiemetics.",2020,"Statistical significance was found in incidence of PONV (0% versus 22.5%) and use of antiemetic (0% versus 5%) between dexamethasone and propofol groups, respectively, at 12-24 hours.","['in Ear, Nose, and Throat Surgery in Tikur Anbessa Specialized Hospital and Yekatit 12th Hospital, Addis Ababa, Ethiopia', '80 patients, with ASA I and II, aged 18-65 years, and scheduled for ENT surgery between December 20, 2017, and March 20, 2018']","['propofol', 'dexamethasone', 'Dexamethasone', 'Propofol versus Dexamethasone', 'propofol and dexamethasone', 'dexamethasone and propofol', 'intravenous (IV) dexamethasone']","['incidences of PONV', 'incidence of PONV', 'moderate PONV', 'Postoperative Nausea and Vomiting']","[{'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.078429,"Statistical significance was found in incidence of PONV (0% versus 22.5%) and use of antiemetic (0% versus 5%) between dexamethasone and propofol groups, respectively, at 12-24 hours.","[{'ForeName': 'Abere', 'Initials': 'A', 'LastName': 'Tilahun Bantie', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Health Sciences, Adigrat University, Adigrat, Ethiopia.'}, {'ForeName': 'Wosenyeleh', 'Initials': 'W', 'LastName': 'Admasu', 'Affiliation': 'School of Anesthesiology, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Sintayehu', 'Initials': 'S', 'LastName': 'Mulugeta', 'Affiliation': ""Department of Anesthesiology, College of Health Sciences, Mekelle University, Mek'ele, Ethiopia.""}, {'ForeName': 'Abera Regassa', 'Initials': 'AR', 'LastName': 'Bacha', 'Affiliation': 'Department of Anesthesiology, College of Medicine and Health Sciences, Axum University, Axum, Ethiopia.'}, {'ForeName': 'Desalegn', 'Initials': 'D', 'LastName': 'Getnet Demsie', 'Affiliation': 'Department of Pharmacy, College of Medicine and Health Sciences, Adigrat University, Adigrat, Ethiopia.'}]",Anesthesiology research and practice,['10.1155/2020/4258137']
2663,32963565,Chinese Herbal Formula Xuefu Zhuyu for Tension-Type Headache with  Qi -Stagnation and Blood-Stasis Pattern (CheruXTH): Study Protocol for a Randomized Controlled Trial.,"Background


Tension-type headache (TTH) is the most common headache disorder. Current treatments for TTH have been reported to be associated with insufficient long-term benefits and unwanted adverse events (AEs). The Chinese herbal formula Xuefu Zhuyu (XFZY) has been utilized in TTH treatment, but the evidence supporting its efficacy remains unclear. This study will evaluate the efficacy and safety of XFZY for TTH.
Methods


This multicenter, double-blind, randomized, placebo-controlled trial will be undertaken in China. A total of 174 eligible participants will be randomly assigned to either an XFZY group or a placebo group (20 ml each dose, three times daily for 4 weeks) at a ratio of 1 : 1. The primary outcome is the change in mean headache intensity measured by a 10 cm visual analogue scale (VAS). Secondary outcomes include the area-under-the headache curve (AUC), headache frequency, rescue medication use,  qi-stagnation and blood-stasis  pattern measurement, quality of life measured by the EuroQol-5-Dimensions-5-Level (EQ-5D-5L), global evaluation of medication, and health economic indexes.  Discussion . The results of the study are expected to provide evidence of high methodological and reporting quality on the efficacy and safety of XFZY for TTH. This trail is registered with ChiCTR1900026716 (registered on 19 October, 2019).",2020,"Secondary outcomes include the area-under-the headache curve (AUC), headache frequency, rescue medication use,  qi-stagnation and blood-stasis  pattern measurement, quality of life measured by the EuroQol-5-Dimensions-5-Level (EQ-5D-5L), global evaluation of medication, and health economic indexes.  ",['174 eligible participants'],"['placebo', 'XFZY', '\n\n\nTension-type headache (TTH']","['efficacy and safety', 'area-under-the headache curve (AUC), headache frequency, rescue medication use,  qi-stagnation and blood-stasis  pattern measurement, quality of life measured by the EuroQol-5-Dimensions-5-Level (EQ-5D-5L), global evaluation of medication, and health economic indexes', 'Qi -Stagnation and Blood-Stasis Pattern (CheruXTH', 'change in mean headache intensity measured by a 10\u2009cm visual analogue scale (VAS']","[{'cui': 'C4517604', 'cui_str': '174'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1956470', 'cui_str': 'Xuefu Zhuyu'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0333138', 'cui_str': 'Stasis'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",174.0,0.630928,"Secondary outcomes include the area-under-the headache curve (AUC), headache frequency, rescue medication use,  qi-stagnation and blood-stasis  pattern measurement, quality of life measured by the EuroQol-5-Dimensions-5-Level (EQ-5D-5L), global evaluation of medication, and health economic indexes.  ","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China.'}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shaojun', 'Initials': 'S', 'LastName': 'Liao', 'Affiliation': 'Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China.'}, {'ForeName': 'Pengqin', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China.'}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China.'}, {'ForeName': 'Zehuai', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/5653169']
2664,32963567,Effect of Huoxiang Zhengqi Pill on Early Neurological Deterioration in Patients with Acute Ischemic Stroke Undergoing Recanalization Therapy and Predictive Effect of Essen Score.,"Early neurologic deterioration (END) in the acute phase of ischemic stroke is a serious clinical event, which is closely related to poor prognosis. Therefore, it is important to identify presentation features that predict END and take relevant treatment measures, as they could help to prevent the deterioration of high-risk patients. The prospective intervention study was carried out from January 2018 to December 2019. We included consecutive patients hospitalized for acute ischemic stroke (AIS) within 6 hours of onset. Patients were randomly assigned (1 : 1) to recanalization therapy plus Huoxiang Zhengqi Pill (HXZQ) (intervention group) or standard recanalization therapy alone (control group). The primary outcome was the development of END according to predefined criteria within the first 1 week of stroke onset. Poisson regression was used to identify predictors for END. Of the 155 patients enrolled in the study (age, 63 ± 11 years; 28.4% female), 20 (12.9%) developed END. Univariate analysis showed that the use of HXZQ and Essen stroke risk score (ESRS) (low risk group) were protective factors for END, while advanced age was a risk factor for END. However, in multivariate analysis, only ESRS (OR, 0.232; 95%CI, 0.058-0.928;  P =0.039) and the use of HXZQ (OR, 0.297; 95%CI, 0.096-0.917;  P =0.035) were statistically significant. ESRS can be used as the prediction factor of END. HXZQ has small side effects and wide indication. It could be used in the treatment of AIS.",2020,"Univariate analysis showed that the use of HXZQ and Essen stroke risk score (ESRS) (low risk group) were protective factors for END, while advanced age was a risk factor for END.","['155 patients enrolled in the study (age, 63\u2009±\u200911 years; 28.4% female), 20 (12.9%) developed END', 'consecutive patients hospitalized for acute ischemic stroke (AIS) within 6 hours of onset', 'Patients with Acute Ischemic Stroke Undergoing Recanalization Therapy and Predictive Effect of Essen Score', 'January 2018 to December 2019']","['HXZQ', 'ESRS', 'recanalization therapy plus Huoxiang Zhengqi Pill (HXZQ) (intervention group) or standard recanalization therapy alone (control group', 'Huoxiang Zhengqi Pill']","['HXZQ and Essen stroke risk score (ESRS', 'development of END according to predefined criteria within the first 1 week of stroke onset', 'Early Neurological Deterioration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",155.0,0.0423829,"Univariate analysis showed that the use of HXZQ and Essen stroke risk score (ESRS) (low risk group) were protective factors for END, while advanced age was a risk factor for END.","[{'ForeName': 'Zhi-Xin', 'Initials': 'ZX', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Guangdong Second Provincial General Hospital, Southern Medical University, Guangzhou 510317, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'P3 Biosafety Laboratory, Guangdong Second Provincial General Hospital, Southern Medical University, Guangzhou 510317, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, The Second School of Clinical Medicine, Southern Medical University, Guangzhou 510317, China.'}, {'ForeName': 'Ying-Yi', 'Initials': 'YY', 'LastName': 'Dai', 'Affiliation': 'Department of Neurology, Guangdong Second Provincial General Hospital, Southern Medical University, Guangzhou 510317, China.'}, {'ForeName': 'Songbin', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Guangdong Second Provincial General Hospital, Southern Medical University, Guangzhou 510317, China.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Guangdong Second Provincial General Hospital, Southern Medical University, Guangzhou 510317, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/6912015']
2665,32963638,"Impacts of Respiratory Muscle Training on Respiratory Functions, Maximal Exercise Capacity, Functional Performance, and Quality of Life in School-Aged Children with Postoperative Congenital Diaphragmatic Hernia.","Objectives


Congenital diaphragmatic hernia (CDH) is a birth defect affecting the respiratory functions, functional performance, and quality of life (QOL) in school-aged children. Rarely have studies been conducted to evaluate the impacts of respiratory muscle training on school-aged children with postoperative CDH. The current study was designed to evaluate the impacts of respiratory muscle training on respiratory function, maximal exercise capacity, functional performance, and QOL in these children.
Methods


This study is a randomized control study. 40 children with CDH (age: 9-11 years) were assigned randomly into two groups. The first group conducted an incentive spirometer exercise combined with inspiratory muscle training (study group,  n  = 20), whereas the second group conducted only incentive spirometer exercise (control group,  n  = 20), thrice weekly for twelve consecutive weeks. Respiratory functions, maximal exercise capacity, functional performance, and pediatric quality of life inventory (PedsQL) were assessed before and after the treatment program . Results . Regarding the posttreatment analysis, the study group showed significant improvements in all outcome measures (FVC%,  p  < 0.001; FEV1%,  p  = 0.002; VO 2 max,  p  = 0.008; VE/VCO 2  slope,  p  = 0.002; 6-MWT,  p  < 0.001; and PedsQL,  p  < 0.001), whereas the control group did not show significant changes ( p  > 0.05).
Conclusion


Respiratory muscle training may improve respiratory functions, maximal exercise capacities, functional performance, and QOL in children with postoperative CDH. Clinical commendations have to be considered to include respiratory muscle training in pulmonary rehabilitation programs in children with a history of CDH.",2020,"Respiratory functions, maximal exercise capacity, functional performance, and pediatric quality of life inventory (PedsQL) were assessed before and after the treatment program .","['school-aged children', 'children with postoperative CDH', '40 children with CDH (age: 9-11 years', 'children with a history of CDH', 'school-aged children with postoperative CDH', 'School-Aged Children with Postoperative Congenital Diaphragmatic Hernia']","['incentive spirometer exercise combined with inspiratory muscle training (study group,  n  = 20), whereas the second group conducted only incentive spirometer exercise (control group', 'Congenital diaphragmatic hernia (CDH', 'Respiratory Muscle Training', 'respiratory muscle training']","['Respiratory Functions, Maximal Exercise Capacity, Functional Performance, and Quality of Life', 'respiratory function, maximal exercise capacity, functional performance, and QOL', 'respiratory functions, functional performance, and quality of life (QOL', 'Respiratory functions, maximal exercise capacity, functional performance, and pediatric quality of life inventory (PedsQL', 'respiratory functions, maximal exercise capacities, functional performance, and QOL']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0235833', 'cui_str': 'Congenital diaphragmatic hernia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0235833', 'cui_str': 'Congenital diaphragmatic hernia'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",40.0,0.0404221,"Respiratory functions, maximal exercise capacity, functional performance, and pediatric quality of life inventory (PedsQL) were assessed before and after the treatment program .","[{'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Alshimaa R', 'Initials': 'AR', 'LastName': 'Azab', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Zizi M', 'Initials': 'ZM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",Disease markers,['10.1155/2020/8829373']
2666,32963641,"A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Hyaluronidase PH20 Administered Intravenously in Healthy Volunteers.","Background


Recombinant human hyaluronidase PH20 (rHuPH20) is used in subcutaneous formulations (eg, RITUXAN HYCELA [rituximab and hyaluronidase human], HERCEPTIN HYLECTA [trastuzumab and hyaluronidase-oysk], PHESGO [pertuzumab/trastuzumab/hyaluronidase-zzxf], and Darzalex FASPRO [daratumumab and hyaluronidase-fihj]) to increase the dispersion and absorption of coadministered therapeutics. Although unlikely, subcutaneous products that include rHuPH20 could be mistaken for the intravenous formulation of the corresponding drugs (eg, RITUXAN [rituximab], HERCEPTIN [trastuzumab], and DARZALEX [daratumumab]). To understand the potential effects of inadvertent intravenous injection of rHuPH20, we investigated the safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of rHuPH20 administered intravenously.
Objectives


This Phase I, open-label, single-center study in healthy volunteers was designed to assess the safety profile, tolerability, PK, and PD of rHuPH20 administered intravenously.
Methods


Healthy volunteers received 5 mL intravenous infusion of either 10,000 U (n = 12) or 30,000 U (n = 12) rHuPH20 over 5 minutes. Blood samples for PK and PD analysis were obtained at baseline and at various times after initiation of infusion. Adverse events and laboratory parameters were measured to assess the safety profile and tolerability of the intravenous infusion. The PK of rHuPH20 was assessed using both an enzymatic assay and a mass-based immunoassay, and plasma hyaluronan concentrations were measured as a PD marker using an HPLC-MS/MS disaccharide assay.
Results


All 24 volunteers (mean age = 36.5 years) completed the study, and no serious adverse events were reported in either treatment group. Overall, 2 adverse events (both Grade 1) were reported; catheter site pain in the 10,000 U group and hypotension in the 30,000 U group. Plasma concentrations of rHuPH20 increased during the 5-minute intravenous infusion (median t max  = 6 minutes from intravenous initiation) followed by a rapid plasma clearance (t 1/2  ∼10 minutes from intravenous initiation). Plasma hyaluronan concentrations increased with dose and time (t max  range = 45‒120 minutes from intravenous initiation) and returned to baseline within 1 week of administration. Changes in both PK and PD measurements appeared proportional to dose.
Conclusions


The study demonstrated that intravenous administration of up to 30,000 U rHuPH20 was well tolerated, rapidly cleared from the plasma, and did not appear to be associated with any serious adverse effects at doses used in subcutaneous therapeutic products. ( Curr Ther Res Clin Exp . 2020; 81).",2020,Plasma hyaluronan concentrations increased with dose and time (t max  range = 45‒120 minutes from intravenous initiation) and returned to baseline within 1 week of administration.,"['Healthy volunteers', 'Healthy Volunteers', 'healthy volunteers', 'All 24 volunteers (mean age\u202f=\u202f36.5 years']","['rHuPH20 administered intravenously', '\n\n\nRecombinant human hyaluronidase PH20 (rHuPH20', 'rHuPH20', 'Recombinant Human Hyaluronidase PH20']","['hypotension', 'enzymatic assay and a mass-based immunoassay, and plasma hyaluronan concentrations', 'safety profile and tolerability', 'safety profile, pharmacokinetics (PK), and pharmacodynamics (PD', 'Plasma concentrations of rHuPH20', 'catheter site pain', 'Plasma hyaluronan concentrations', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics', 'safety profile, tolerability, PK, and PD of rHuPH20 administered intravenously']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1720035', 'cui_str': 'Recombinant human hyaluronidase'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C2717977', 'cui_str': 'Enzymatic Assays'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020980', 'cui_str': 'Immunoassay method'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1720035', 'cui_str': 'Recombinant human hyaluronidase'}, {'cui': 'C0949103', 'cui_str': 'Catheter site pain'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]",24.0,0.0409629,Plasma hyaluronan concentrations increased with dose and time (t max  range = 45‒120 minutes from intravenous initiation) and returned to baseline within 1 week of administration.,"[{'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Printz', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, California.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Dychter', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, California.'}, {'ForeName': 'Emanuel P', 'Initials': 'EP', 'LastName': 'DeNoia', 'Affiliation': 'Icon Development Solutions, San Antonio, Texas.'}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Harrigan', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, California.'}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Sugarman', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, California.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Zepeda', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Souratha', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, California.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Kang', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, California.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Maneval', 'Affiliation': 'Halozyme Therapeutics, Inc, San Diego, California.'}]","Current therapeutic research, clinical and experimental",['10.1016/j.curtheres.2020.100604']
2667,32963688,"Artemisia Annua  sublingual immunotherapy for seasonal allergic rhinitis: A multicenter, randomized trial.","Background


Artemisia annua  is the most common outdoor aeroallergen throughout Northern China; however, no multicenter study has investigated sublingual immunotherapy (SLIT) as a treatment option for  Artemisia annua -induced allergic rhinitis (AR). The aim of this study was to evaluate the efficacy and safety of an innovative SLIT for  Artemisia annua -related AR.
Methods


This was a randomized, double-blind, placebo-controlled, multicenter, phase 3 clinical trial conducted in China (NCT XXX). A total of 702  Artemisia annua -sensitized eligible patients were randomized in a ratio of 2:1 to receive  Artemisia annua -SLIT or placebo. The treatment lasted 32 weeks; including 5-weeks up-dosing phase and 27-weeks maintenance phase. The primary endpoint was the daily combined score of medication and rhinoconjunctivitis symptom (CSMRS), and secondary endpoints were daily total nasal symptom score (dTNSS) and daily rescue medication score (dRMS) during peak pollen period. Safety of treatment was evaluated according to adverse events (AEs) experienced.
Results


Mean daily CSMRS was significantly improved during the peak pollen period in the SLIT group compared with the placebo group (1.46 ± 0.47 vs 1.88 ± 0.42, P < 0.0001 in full analysis set [FAS]; 1.49 ± 0.52 vs 1.95 ± 0.46, P < 0.0001 in per protocol set [PPS]); representing a 22.3% and 23.6% reduction, respectively, relative to placebo. In specifically  Artemisia annua  monosensitized patients, mean daily CSMRS reductions were demonstrated as 24.1% and 27.0% in the FAS and PPS populations, respectively, when comparing the active treatment to placebo treatment. Similarly, SLIT decreased dTNSS in peak pollen period by 19.0% in FAS and 22.3% in PPS, respectively, relative to placebo. In coincidence, dRMS in peak pollen period was reduced by 22.0% in FAS and 26.0% in PPS. 65.8% patients in SLIT group experienced treatment-related AEs, none of which was serious.
Conclusion


This study indicates that SLIT with  Artemisia annua  drops is an effective and safe treatment option in Chinese patients with  Artemisia Annua -induced AR.",2020,"Mean daily CSMRS was significantly improved during the peak pollen period in the SLIT group compared with the placebo group (1.46 ± 0.47 vs 1.88 ± 0.42, P < 0.0001 in full analysis set [FAS]; 1.49 ± 0.52 vs 1.95 ± 0.46, P ","['Artemisia annua -induced allergic rhinitis (AR', 'seasonal allergic rhinitis', 'Chinese patients with  Artemisia Annua -induced AR', 'A total of 702  Artemisia annua -sensitized eligible patients']","['innovative SLIT', 'Artemisia annua -SLIT or placebo', 'sublingual immunotherapy (SLIT', 'China (NCT XXX', 'Artemisia Annua  sublingual immunotherapy', 'placebo', 'SLIT']","['daily combined score of medication and rhinoconjunctivitis symptom (CSMRS), and secondary endpoints were daily total nasal symptom score (dTNSS) and daily rescue medication score (dRMS', 'peak pollen period', 'efficacy and safety', 'Mean daily CSMRS', 'mean daily CSMRS reductions']","[{'cui': 'C0686899', 'cui_str': 'Artemisia annua'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0686899', 'cui_str': 'Artemisia annua'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C1832370', 'cui_str': 'Desmin-related myofibrillar myopathy'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032385', 'cui_str': 'Pollen'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",702.0,0.351362,"Mean daily CSMRS was significantly improved during the peak pollen period in the SLIT group compared with the placebo group (1.46 ± 0.47 vs 1.88 ± 0.42, P < 0.0001 in full analysis set [FAS]; 1.49 ± 0.52 vs 1.95 ± 0.46, P ","[{'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Lou', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, 100730, China.'}, {'ForeName': 'Xueyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Allergy, No. 202 Hospital of PLA (General Hospital of Northern Theater Command), Shenyang 110003, China.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Otorhinolaryngology, Second Hospital of Shanxi Medical University, Taiyuan, 030001, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Xing', 'Affiliation': ""Department of Otorhinolaryngology, Peking University People's Hospital, Beijing, 100044, China.""}, {'ForeName': 'Qinna', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, First Hospital of Shanxi Medical University, Taiyuan, 030001, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': 'Department of Otolaryngology, West China Hospital, Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Shaoqiang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Otorhinolaryngology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'Huifang', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Otorhinolaryngology, Tianjin Medical University General Hospital, Tianjin, 300052, China.'}, {'ForeName': 'Ruixia', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, General Hospital of Ningxia Medical University, Yinchuan 750004, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Otorhinolaryngology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830011, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology, Shanxi Provincial People's Hospital, Xi'an, 710068, China.""}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Department of Otorhinolaryngology, Qingdao Municipal Hospital, Qingdao, 266011, China.'}, {'ForeName': 'Chengshuo', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, 100730, China.'}, {'ForeName': 'Luo', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, 100730, China.'}]",The World Allergy Organization journal,['10.1016/j.waojou.2020.100458']
2668,32963955,"""Effects of flap modification on third molar extraction outcomes""-A randomised split mouth study.","Aim


The main purpose of this experimental study was to compare whether modifications in flap design influence the post-operative outcome of third molar surgeries.
Materials and methods


This study was designed as a randomized, single-blinded,split-mouth cross-over comparative study. The predictor variables were the flap type; Conventional Ward's was used to expose the tooth with a difference in the anterior release incision between the groups.Oblique anterior releasing incision and vertical anterior releasing incisions were used for the control and study group respectively.The primary outcome variables were pain measured using VAS (Visual analogue scale), swelling in mm; mouth opening measured in mm, periodontal probing depth in a mm, wound healing by modified Landry's score and surgical accessibility. Statistical significance was set at 5% (α = 0.05).
Result


Twenty five patients with bilateral, mirror-image impacted mandibular third molars participated in the study.The study group was associated with moderate swelling that was not statistically significant. .The outcome variables i.e. pain, wound healing, mouth opening, and periodontal pocket depth had no statistical difference on comparing the two groups. In terms of accessibility, the control group was found to be better with the statistical significance of p = 0.00184.
Conclusion


Modifying conventional Ward's design influences the degree of swelling and surgical accessibility. Vertical anterior releasing incision in conventional Ward's has no advantage over conventional Ward's with oblique anterior releasing incision.",2020,"In terms of accessibility, the control group was found to be better with the statistical significance of p = 0.00184.
","['Twenty five patients with bilateral, mirror-image impacted mandibular third molars participated in the study']","['Oblique anterior releasing incision and vertical anterior releasing incisions', 'Vertical anterior releasing incision', 'flap modification']","['degree of swelling and surgical accessibility', 'pain, wound healing, mouth opening, and periodontal pocket depth', 'moderate swelling', ""pain measured using VAS (Visual analogue scale), swelling in mm; mouth opening measured in mm, periodontal probing depth in a mm, wound healing by modified Landry's score and surgical accessibility""]","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0031094', 'cui_str': 'Periodontal pocket'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1882337', 'cui_str': 'Periodontal probe'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",25.0,0.0635697,"In terms of accessibility, the control group was found to be better with the statistical significance of p = 0.00184.
","[{'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Sridharan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Ramapuram, Chennai, 600089, Tamil Nadu, India.'}, {'ForeName': 'Komagan Prabhu', 'Initials': 'KP', 'LastName': 'Nakkeeran', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Ramapuram, Chennai, 600089, Tamil Nadu, India.'}, {'ForeName': 'Gnanam', 'Initials': 'G', 'LastName': 'Andavan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Ramapuram, Chennai, 600089, Tamil Nadu, India.'}, {'ForeName': 'Krishna Kumar', 'Initials': 'KK', 'LastName': 'Raja V B', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Ramapuram, Chennai, 600089, Tamil Nadu, India.'}]",Journal of oral biology and craniofacial research,['10.1016/j.jobcr.2020.08.010']
2669,32963954,Comparison of piezosurgery and conventional rotatory technique in transalveolar extraction of mandibular third molars: A pilot study.,"Objectives


To compare the postoperative outcomes in impacted mandibular third molar extraction using piezosurgery and conventional rotary technique; and to assess the stress levels in both the techniques by measuring salivary cortisol levels.
Methods


Ten patients with symmetrical impacted lower third molars were included in this split mouth pilot study. Measurements for mouth opening and swelling were taken preoperatively on the day of surgery and 1 week after surgery. Pain was evaluated using Visual Analog Scale (VAS) from first postoperative day for six consecutive days. Saliva collection for analysis of cortisol levels was done at four time intervals - before starting the procedure, immediately after the procedure, 20 min and 1 week later. The mean in two groups was compared using paired t-test/Wilcoxon signed rank test as applicable. Friedman test was used to compare multiple readings of pain and salivary cortisol.
Results


Reduction in mouth opening was more in rotary group than piezosurgery group but was not statistically significant (p = 0.092). Increase in facial swelling was more in the rotary group than piezosurgery group with statistically significant values (p = 0.020). Rotary group had higher values for postoperative pain as compared to piezosurgery on all the days and the difference was statistically significant on each day except second postoperative day. Salivary cortisol levels were elevated in both the groups with the mean values higher in group I (rotary) than in group II (Piezosurgery).
Conclusion


Extraction of impacted lower third molar results in more favourable outcome when carried out by piezosurgery technique. Further studies are needed to compare the salivary cortisol response in rotary and piezosurgery techniques.",2020,"Results


Reduction in mouth opening was more in rotary group than piezosurgery group but was not statistically significant (p = 0.092).","['Methods\n\n\nTen patients with symmetrical impacted lower third molars', 'transalveolar extraction of mandibular third molars']","['piezosurgery and conventional rotary technique', 'piezosurgery and conventional rotatory technique']","['Results\n\n\nReduction in mouth opening', 'postoperative pain', 'Salivary cortisol levels', 'Visual Analog Scale (VAS', 'Pain', 'salivary cortisol response', 'facial swelling', 'multiple readings of pain and salivary cortisol']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",10.0,0.0570919,"Results


Reduction in mouth opening was more in rotary group than piezosurgery group but was not statistically significant (p = 0.092).","[{'ForeName': 'Nouman', 'Initials': 'N', 'LastName': 'Rashid', 'Affiliation': 'Department of Dentistry, Oral and Maxillofacial Surgery, All India Institute of Medical Sciences (AIIMS), Virbhadra Road, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Vivekanandhan', 'Initials': 'V', 'LastName': 'Subbiah', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences (AIIMS), Virbhadra Road, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Padmanidhi', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Department of Dentistry, Oral and Maxillofacial Surgery, All India Institute of Medical Sciences (AIIMS), Virbhadra Road, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Dentistry, Oral and Maxillofacial Surgery, All India Institute of Medical Sciences (AIIMS), Virbhadra Road, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Adity', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Department of Dentistry, Oral and Maxillofacial Surgery, All India Institute of Medical Sciences (AIIMS), Virbhadra Road, Rishikesh, Uttarakhand, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Neeraj', 'Affiliation': 'Department of Dentistry, Oral and Maxillofacial Surgery, All India Institute of Medical Sciences (AIIMS), Virbhadra Road, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Srinivas Gosla', 'Initials': 'SG', 'LastName': 'Reddy', 'Affiliation': 'Department of Dentistry, Oral and Maxillofacial Surgery, All India Institute of Medical Sciences (AIIMS), Virbhadra Road, Rishikesh, Uttarakhand, India.'}, {'ForeName': 'Ashi', 'Initials': 'A', 'LastName': 'Chug', 'Affiliation': 'Department of Dentistry, Oral and Maxillofacial Surgery, All India Institute of Medical Sciences (AIIMS), Virbhadra Road, Rishikesh, Uttarakhand, India.'}]",Journal of oral biology and craniofacial research,['10.1016/j.jobcr.2020.08.021']
2670,32963979,Effect of Foot Massage on Patients with Chemotherapy Induced Nausea and Vomiting: A Randomized Clinical Trial.,"Introduction:  Cancer is a global problem and it is a leading cause of death worldwide. Nausea, vomiting and retching (NVR) are one of the common side effects that are seen among the majority of the patients undergoing chemotherapy. Foot massage is a complementary therapy that reduces chemotherapy-induced nausea and vomiting and improves the quality of life among cancer patients undergoing chemotherapy. This study aim to measure the effectiveness of foot massage in reduction of nausea, vomiting & retching on patients undergoing chemotherapy treatment.  Methods:  A randomized clinical trial study was used to assess the effect of foot massage on patients with Chemotherapy-induced nausea and vomiting among patients undergoing highly emetogenic chemotherapy. Simple random sampling by the lottery method was used to select newly diagnosed cancer patients who underwent highly emetogenic chemotherapy (N = 82). Rhodes index of nausea, vomiting and retching questionnaire were used for data collection. SPSS 19, two-sample t test, paired t test and chi-square test were used for data analysis.  Results:  Nausea, vomiting, and retching were significantly reduced in the experimental group compared to the control group after the intervention. There was a significant difference between pre-intervention and post-intervention scores within the group.  Conclusion:  The findings of the study revealed that the foot massage therapy is effective in reducing chemotherapy-induced nausea and vomiting among patients undergone highly emetogenic chemotherapy. The study helped to conclude that foot massage can be considered effective intervention in chemotherapy patients.",2020,Foot massage is a complementary therapy that reduces chemotherapy-induced nausea and vomiting and improves the quality of life among cancer patients undergoing chemotherapy.,"['patients undergoing chemotherapy treatment', 'Patients with Chemotherapy Induced Nausea and Vomiting', 'patients with Chemotherapy-induced nausea and vomiting among patients undergoing highly emetogenic chemotherapy', 'newly diagnosed cancer patients who underwent highly emetogenic chemotherapy (N = 82', 'chemotherapy patients', 'cancer patients undergoing chemotherapy', 'patients undergone highly emetogenic chemotherapy']","['Foot massage', 'foot massage', 'Foot Massage']","['Nausea, vomiting and retching (NVR', 'nausea, vomiting & retching', 'Rhodes index of nausea, vomiting and retching questionnaire', 'nausea and vomiting', 'Nausea, vomiting, and retching', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0232602', 'cui_str': 'Retching'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",82.0,0.0526159,Foot massage is a complementary therapy that reduces chemotherapy-induced nausea and vomiting and improves the quality of life among cancer patients undergoing chemotherapy.,"[{'ForeName': 'Cluny', 'Initials': 'C', 'LastName': 'Asha', 'Affiliation': 'Department of Medical-Surgical Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-06, India.'}, {'ForeName': 'Kumari Jayaram', 'Initials': 'KJ', 'LastName': 'Manjini', 'Affiliation': 'Department of Medical-Surgical Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-06, India.'}, {'ForeName': 'Biswajit', 'Initials': 'B', 'LastName': 'Dubashi', 'Affiliation': 'Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-06, India Introduction.'}]",Journal of caring sciences,['10.34172/jcs.2020.018']
2671,32963981,The Effect of Supportive-Training Intervention on the Burnout ofMothers with Disabled Child: A Randomized Clinical Trial.,"Introduction:  Mothers with a disabled child experience excessive stress, fatigue, frustration, and depression. Failure of mothers to effectively deal with these symptoms can lead to chronic fatigue and, in the long run, burnout. The objective of the present study was to determine the effect of supportive-training intervention on the burnout of mothers with disabled children.  Methods:  In this randomized controlled trial, 70 mothers with disabled children studying in special schools were selected in one of the urban areas of Iran. They were divided into two groups of intervention and control, using Minimization Random Method. In the intervention group, mothers participated in supportive-training sessions once a week for a period of 6 weeks. The control group did not receive any special interventions. The data collection tool was a demographic data form and Shirom-Melamed Burnout Questionnaire (SMBQ). Burnout was evaluated as primary outcome at the beginning of the study and one month after the end of the intervention. The data were analyzed by SPSS software version 18.  Results:  Based on the results, there was no significant difference between the mean score of burnout in the intervention and control groups before the intervention. However, after the intervention, the mean score of burnout in the intervention group was significantly lower than that of the control group.  Conclusion:  Considering the positive effect of supportive-training intervention on the burnout of mothers of disabled children, this intervention is recommended by nurses and other health care providers in special schools, health centers, and supportive institutions.",2020,"However, after the intervention, the mean score of burnout in the intervention group was significantly lower than that of the control group.  ","['mothers with disabled children', 'Mothers with a disabled child experience excessive stress, fatigue, frustration, and depression', 'mothers of disabled children', '70 mothers with disabled children studying in special schools were selected in one of the urban areas of Iran', 'Burnout ofMothers with Disabled Child']","['supportive-training intervention', 'Supportive-Training Intervention', 'control group did not receive any special interventions', 'supportive-training sessions']",['mean score of burnout'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0259916', 'cui_str': 'Child, Disabled'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0016770', 'cui_str': 'Feeling frustrated'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}]",70.0,0.024505,"However, after the intervention, the mean score of burnout in the intervention group was significantly lower than that of the control group.  ","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Masoumi', 'Affiliation': 'Department of Medical Surgical Nursing, Student Research Committee, School of Nursing and Midwifery, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Abdoli', 'Affiliation': 'Geriatric Care Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Tabandeh', 'Initials': 'T', 'LastName': 'Sadeghi', 'Affiliation': 'Non-Communicable Diseases Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}]",Journal of caring sciences,['10.34172/jcs.2020.020']
2672,32966830,"Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial.","BACKGROUND


Preferred neoadjuvant regimens for early-stage triple-negative breast cancer (TNBC) include anthracycline-cyclophosphamide and taxane-based chemotherapy. IMpassion031 compared efficacy and safety of atezolizumab versus placebo combined with nab-paclitaxel followed by doxorubicin plus cyclophosphamide as neoadjuvant treatment for early-stage TNBC.
METHODS


This double-blind, randomised, phase 3 study enrolled patients in 75 academic and community sites in 13 countries. Patients aged 18 years or older with previously untreated stage II-III histologically documented TNBC were randomly assigned (1:1) to receive chemotherapy plus intravenous atezolizumab at 840 mg or placebo every 2 weeks. Chemotherapy comprised of nab-paclitaxel at 125 mg/m 2  every week for 12 weeks followed by doxorubicin at 60 mg/m 2  and cyclophosphamide at 600 mg/m 2  every 2 weeks for 8 weeks, which was then followed by surgery. Stratification was by clinical breast cancer stage and programmed cell death ligand 1 (PD-L1) status. Co-primary endpoints were pathological complete response in all-randomised (ie, all randomly assigned patients in the intention-to-treat population) and PD-L1-positive (ie, patients with PD-L1-expressing tumour infiltrating immune cells covering ≥1% of tumour area) populations. This study is registered with ClinicalTrials.gov (NCT03197935), Eudra (CT2016-004734-22), and the Japan Pharmaceutical Information Center (JapicCTI-173630), and is ongoing.
FINDINGS


Between July 7, 2017, and Sept 24, 2019, 455 patients were recruited and assessed for eligibility. Of the 333 eligible patients, 165 were randomly assigned to receive atezolizumab plus chemotherapy and 168 to placebo plus chemotherapy. At data cutoff (April 3, 2020), median follow-up was 20·6 months (IQR 8·7-24·9) in the atezolizumab plus chemotherapy group and 19·8 months (8·1-24·5) in the placebo plus chemotherapy group. Pathological complete response was documented in 95 (58%, 95% CI 50-65) patients in the atezolizumab plus chemotherapy group and 69 (41%, 34-49) patients in the placebo plus chemotherapy group (rate difference 17%, 95% CI 6-27; one-sided p=0·0044 [significance boundary 0·0184]). In the PD-L1-positive population, pathological complete response was documented in 53 (69%, 95% CI 57-79) of 77 patients in the atezolizumab plus chemotherapy group versus 37 (49%, 38-61) of 75 patients in the placebo plus chemotherapy group (rate difference 20%, 95% CI 4-35; one-sided p=0·021 [significance boundary 0·0184]). In the neoadjuvant phase, grade 3-4 adverse events were balanced and treatment-related serious adverse events occurred in 37 (23%) and 26 (16%) patients, with one patient per group experiencing an unrelated grade 5 adverse event (traffic accident in the atezolizumab plus chemotherapy group and pneumonia in the placebo plus chemotherapy group).
INTERPRETATION


In patients with early-stage TNBC, neoadjuvant treatment with atezolizumab in combination with nab-paclitaxel and anthracycline-based chemotherapy significantly improved pathological complete response rates with an acceptable safety profile.
FUNDING


F Hoffmann-La Roche/Genentech.",2020,"Pathological complete response was documented in 95 (58%, 95% CI 50-65) patients in the atezolizumab plus chemotherapy group and 69 (41%, 34-49) patients in the placebo plus chemotherapy group (rate difference 17%, 95% CI 6-27; one-sided p=0·0044 [significance boundary 0·0184]).","['333 eligible patients', 'patients with early-stage triple-negative breast cancer (IMpassion031', 'Patients aged 18 years or older with previously untreated stage II-III', 'early-stage triple-negative breast cancer (TNBC', 'Between July 7, 2017, and Sept 24, 2019, 455 patients were recruited and assessed for eligibility', 'enrolled patients in 75 academic and community sites in 13 countries']","['sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy', 'chemotherapy plus intravenous atezolizumab at 840 mg or placebo', 'Neoadjuvant atezolizumab', 'atezolizumab plus chemotherapy', 'atezolizumab in combination with nab-paclitaxel and anthracycline-based chemotherapy', 'placebo combined with nab-paclitaxel', 'Chemotherapy comprised of nab-paclitaxel', 'placebo plus chemotherapy', 'doxorubicin at 60 mg/m 2  and cyclophosphamide', 'atezolizumab', 'doxorubicin plus cyclophosphamide', 'anthracycline-cyclophosphamide and taxane-based chemotherapy']","['efficacy and safety', 'Pathological complete response', 'pathological complete response', 'pathological complete response rates', 'serious adverse events']","[{'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0215136', 'cui_str': 'taxane'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",455.0,0.693364,"Pathological complete response was documented in 95 (58%, 95% CI 50-65) patients in the atezolizumab plus chemotherapy group and 69 (41%, 34-49) patients in the placebo plus chemotherapy group (rate difference 17%, 95% CI 6-27; one-sided p=0·0044 [significance boundary 0·0184]).","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mittendorf', 'Affiliation': ""Dana-Farber/Brigham and Women's Cancer Center, Boston, MA, USA. Electronic address: emittendorf@bwh.harvard.edu.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa em Oncologia, Hospital São Lucas, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Koehler', 'Affiliation': 'Gemeinschaftspraxis für Haematologie und Onkologie Langen, Langen, Germany.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Telli', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Ferrario', 'Affiliation': 'Jewish General Hospital-McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Punie', 'Affiliation': 'Department of General Medical Oncology and Multidisciplinary Breast Centre, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Penault-Llorca', 'Affiliation': 'Department of Biopathology, Centre Jean Perrin and University Clermont Auvergne/INSERM U1240, Clermont-Ferrand, France.'}, {'ForeName': 'Shilpen', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Anh Nguyen', 'Initials': 'AN', 'LastName': 'Duc', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Liste-Hermoso', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Maiya', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Molinero', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen Y', 'Initials': 'SY', 'LastName': 'Chui', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, Department of Gynecology and Obstetrics and Comprehensive Cancer Center of the Ludwig-Maximilians-University, Munich, Germany.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31953-X']
2673,32966832,Rapid reduction in plaque inflammation by sonodynamic therapy in patients with symptomatic femoropopliteal peripheral artery disease: A randomized controlled trial.,"BACKGROUND


Inflammation is actively involved in the clinical manifestation of peripheral artery disease (PAD). Sonodynamic therapy (SDT), a novel non-invasive, plaque-based, macrophage-targeted anti-inflammatory regimen for atherosclerosis has the potential to improve walking performance by reducing plaque inflammation.
METHODS


This phase-2, randomized, sham-controlled, double-blind clinical trial enrolled 32 participants with symptomatic femoropopliteal PAD. The primary outcome was the 30-day change in the target-to-background ratio (TBR) within the most diseased segment (MDS) of the femoropopliteal artery assessed through positron emission tomography/computed tomography (PET/CT). The secondary outcomes were changes in walking performance, limb perfusion, lesional morphology and quality of life measurements.
RESULTS


The mean age was 64.7 years and 63% were male. Thirty-one completed follow-up. SDT significantly decreased the MDS TBR by 0.53 (95% CI, -0.70 to -0.36, P < 0.001) compared with control. Furthermore, SDT increased peak walking time by 118.6 s (95% CI, 74.3 to 163.0, P < 0.001), increased ankle-brachial index by 0.11 (95% CI, 0.07 to 0.14, P < 0.001), decreased lesional diameter and area stenosis by 7.2% (95% CI, -8.6 to -4.5, P < 0.001) and 9.6% (95% CI, -24.5 to -5.3, P = 0.005), respectively, and increased the walking speed score of the Walking Impairment Questionnaire by 16.1 (95% CI, 2.6 to 29.5, P = 0.021) and the physical functioning score of the 36-item Short-Form Health Survey by 10.0 (95% CI, 5.0 to 20.0, P = 0.003) compared with control. These improvements were maintained in the SDT group up to 6-month.
CONCLUSIONS


SDT rapidly reduced plaque inflammation and improved walking performance among patients with symptomatic PAD.
TRIAL REGISTRATION


Clinical Trials NCT03457662.",2020,"Furthermore, SDT increased peak walking time by 118.6 s (95% CI, 74.3 to 163.0, P < 0.001), increased ankle-brachial index by 0.11 (95% CI, 0.07 to 0.14, P < 0.001), decreased lesional diameter and area stenosis by 7.2% (95% CI, -8.6 to -4.5, P ","['32 participants with symptomatic femoropopliteal PAD', 'patients with symptomatic PAD', 'The mean age was 64.7\u202fyears and 63% were male', 'patients with symptomatic femoropopliteal peripheral artery disease']","['Sonodynamic therapy (SDT', 'sonodynamic therapy']","['walking speed score of the Walking Impairment Questionnaire', 'plaque inflammation', 'changes in walking performance, limb perfusion, lesional morphology and quality of life measurements', 'MDS TBR', 'lesional diameter and area stenosis', '30-day change in the target-to-background ratio (TBR) within the most diseased segment (MDS) of the femoropopliteal artery assessed through positron emission tomography/computed tomography (PET/CT', 'physical functioning score of the 36-item Short-Form Health Survey', 'plaque inflammation and improved walking performance', 'ankle-brachial index', 'peak walking time']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0190886', 'cui_str': 'Perfusion of limb'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",32.0,0.373441,"Furthermore, SDT increased peak walking time by 118.6 s (95% CI, 74.3 to 163.0, P < 0.001), increased ankle-brachial index by 0.11 (95% CI, 0.07 to 0.14, P < 0.001), decreased lesional diameter and area stenosis by 7.2% (95% CI, -8.6 to -4.5, P ","[{'ForeName': 'Yongxing', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Jingxue', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of PET/CT, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, PR China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Yuanqi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Jiemei', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Mengjiao', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of PET/CT, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, PR China.'}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Qiannan', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Zhengyan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Bicheng', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Fengyu', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China; Department of Epidemiology and Biostatistics, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Haiyu', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China; Department of Epidemiology and Biostatistics, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Laboratory of Photo- and Sono-theranostic Technologies and Condensed Matter Science and Technology Institute, Harbin Institute of Technology, Harbin, PR China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, Harbin Medical University, Harbin, PR China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital, Cardiovascular Institute, Harbin Medical University, Harbin, PR China; Department of Pathophysiology and Key Laboratory of Cardiovascular Pathophysiology, Harbin Medical University, Key Laboratory of Cardiovascular Medicine Research (Harbin Medical University), Ministry of Education, Harbin, PR China. Electronic address: yetian@ems.hrbmu.edu.cn.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.09.035']
2674,32966877,Real-world exposure to graphic warning labels on cigarette packages in US smokers: The CASA randomized trial protocol.,"BACKGROUND


The US lags behind >120 countries in implementing graphic warning labels (GWLs) on cigarette packs. US courts prevented implementation of FDA's 2012 rule requiring GWLs citing the need for more evidence on effectiveness. After more research, in 2020, the FDA proposed a revised rule mandating GWLs. This trial will test how the introduction of GWLs influence cognitions and behavior in US smokers.
METHOD


To investigate the ""real world"" impact of GWLs in US smokers, we are conducting a randomized trial involving a 3-month intervention and 8-month follow-up. The study recruited California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1) Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack. Throughout the 3-month intervention, participants purchased study-packaged cigarettes and reported daily cognitions and behavior through ecological momentary assessments. We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
RESULTS


The trial enrolled 359 participants (average age 39 years; average cigarette consumption half a pack/day). The 3 study groups were balanced on age, gender, race-ethnicity, education and income (17% low income) as well as on smoking related variables.
CONCLUSIONS


This 3-month real-world randomized trial will test the effect of repackaging cigarettes from standard US packs to GWL plain packs on smokers' perceptions of the risks of smoking, their perception of the appeal of their cigarettes, and on their smoking behavior.",2020,"We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
","['US smokers', 'California smokers between September 2016 through December 2019 and randomly assigned them into 3 groups (1', '359 participants (average age 39\u202fyears; average cigarette consumption half a pack/day']","['Blank Pack devoid of any cigarette branding; (2) GWL Pack featuring 1 of 3 rotating images added to blank pack; or (3) their usual Standard US Pack', 'Real-world exposure to graphic warning labels', 'repackaging cigarettes from standard US packs to GWL plain packs']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",[],359.0,0.0172592,"We will validate self-reported tobacco use with saliva cotinine concentrations following the 3-month intervention and 8-month follow-up.
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pierce John', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: jppierce@ucsd.edu.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Strong David', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: dstrong@ucsd.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stone Matthew', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: m3stone@ucsd.edu.'}, {'ForeName': 'Villaseñor', 'Initials': 'V', 'LastName': 'Adriana', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: adriana.villasenor@sdcounty.ca.gov.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Dimofte Claudiu', 'Affiliation': 'Department of Marketing, San Diego State University, 5500 Campanile Dr, San Diego, CA 92182, United States. Electronic address: cdimofte@sdsu.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leas Eric', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ecleas@ucsd.edu.'}, {'ForeName': 'Oratowski', 'Initials': 'O', 'LastName': 'Jesica', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: joratowski@ucsd.edu.'}, {'ForeName': 'Brighton', 'Initials': 'B', 'LastName': 'Elizabeth', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ebrighton@ucsd.edu.'}, {'ForeName': 'Hurst', 'Initials': 'H', 'LastName': 'Samantha', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States. Electronic address: shurst@ucsd.edu.'}, {'ForeName': 'Pulvers', 'Initials': 'P', 'LastName': 'Kimberley', 'Affiliation': 'Department of Psychology, Social and Behavioral Sciences Building, California State University, San Marcos 200 E Barham Dr, San Marcos, CA, 92096, United States. Electronic address: kpulvers@csusm.edu.'}, {'ForeName': 'Kealey', 'Initials': 'K', 'LastName': 'Sheila', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ruifeng', 'Affiliation': 'Division of Biostatistics, Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: ruc075@ucsd.edu.'}, {'ForeName': 'Messer', 'Initials': 'M', 'LastName': 'Karen', 'Affiliation': 'Cancer Control Program, Moores Cancer Center, UC San Diego, 3855 Health Sciences Drive, La Jolla, CA 92093-0901, United States; Division of Biostatistics, Department of Family Medicine and Public Health, UC San Diego, 9500 Gilman Drive, La Jolla, CA 92093, United States. Electronic address: kmesser@ucsd.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106152']
2675,32966919,"Effects of vitamin D supplementation on core symptoms, serum serotonin, and interleukin-6 in children with autism spectrum disorders: A randomized clinical trial.","OBJECTIVES


Children with autism spectrum disorders (ASD) have lower serum vitamin D and higher serotonin and interleukin (IL)-6 levels compared with healthy children. The aim of this study was to evaluate the effect of vitamin D on core symptoms and serum levels of serotonin and IL-6 in these children.
METHODS


This parallel randomized double-blind, placebo-controlled trial was conducted with 43 children with ASD (7 girls and 36 boys; 8.91 ± 2.87 y of age). Children were randomly allocated to receive either vitamin D drop (300 IU/kg up to a maximum of 6000 IU daily) or placebo for 15 wk. Serum levels of 25-hydroxyvitamin (OH)D, IL-6, and serotonin were measured at baseline and at the end of the trial. Also, the severity of autism and the social and individual maturity of the children were measured by the Childhood Autism Rating Scale (CARS), the Autism Treatment Assessment Checklist (ATEC), and Aberrant Behavior Checklist-Community (ABC-C) questionnaires before and after intervention. Randomization and allocation to groups were done using computer-generated numbers.
RESULTS


More than 86% of patients had vitamin D deficiency at the beginning of the study. Serum levels of 25(OH)D increased significantly in the vitamin D group (P = 0.001). The clinical symptoms of autism measured by CARS and ATEC scales were alleviated significantly (P = 0.021 and P = 0.020, respectively); however, the serum levels of serotonin and IL-6 and the scale of ABC-C remained without a significant change.
CONCLUSION


These findings suggest that vitamin D supplementation may improve ASD symptoms; however, more studies with longer duration are indispensable to confirm our results.",2020,Serum levels of 25(OH)D increased significantly in the vitamin D group (P = 0.001).,"['43 children with ASD (7 girls and 36 boys; 8.91 ±', 'children with autism spectrum disorders', 'Children with autism spectrum disorders (ASD']","['vitamin D supplementation', 'placebo', 'vitamin D']","['Childhood Autism Rating Scale (CARS), the Autism Treatment Assessment Checklist (ATEC), and Aberrant Behavior Checklist-Community (ABC-C) questionnaires', 'Serum levels of 25(OH)D', 'ASD symptoms', 'serum levels of serotonin and IL-6 and the scale of ABC-C', 'CARS and ATEC scales', 'core symptoms, serum serotonin, and interleukin-6', 'serum vitamin D and higher serotonin and interleukin (IL)-6 levels', 'vitamin D deficiency', 'Serum levels of 25-hydroxyvitamin (OH)D, IL-6, and serotonin']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C2209695', 'cui_str': 'Serum serotonin'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]",43.0,0.328924,Serum levels of 25(OH)D increased significantly in the vitamin D group (P = 0.001).,"[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Javadfar', 'Affiliation': 'Student Research Committee, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Abdollahzad', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran; Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: hadi_nut@yahoo.com.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Moludi', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Rezaeian', 'Affiliation': 'Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Houshang', 'Initials': 'H', 'LastName': 'Amirian', 'Affiliation': 'Department of Psychiatry, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Ali Akbar', 'Initials': 'AA', 'LastName': 'Foroughi', 'Affiliation': 'Department of Clinical Psychology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Seyed Mostafa', 'Initials': 'SM', 'LastName': 'Nachvak', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Goharmehr', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Mostafai', 'Affiliation': 'Department of Nutritional Sciences, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110986']
2676,32966959,Within-person networks of clinical features of social anxiety disorder during cognitive and interpersonal therapy.,"Analysis of longitudinal within-person networks over the course of therapy allows an identification of possible targets of treatment. This study examined within-person networks of clinical features in social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy. Patients (n = 80) were randomized to either CT or IPT in a 10 week residential program. They completed a measure of clinical features two times a week. The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses. The multilevel vector autoregressive (mlVAR) model was used to analyze the data, producing a temporal, contemporaneous, and between-person network. In the temporal network and as expected, more homework compliance in a half-week predicted less social anxiety and less social avoidance the subsequent half-week. Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus. Unexpectedly, less social avoidance predicted more self-focus and less self-focus predicted less social function and social joy. In the contemporaneous network, self-focus, anxiety and avoidance displayed a conditional independence structure. The estimated temporal network suggests that homework compliance and social function are promising targets of treatment.",2020,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","['social anxiety disorder (SAD) patients during cognitive (CT) and interpersonal (IPT) therapy', 'The 60 (75 %) patients who had completed at least 18 measurements were included in the analyses', 'Patients (n = 80']","['cognitive and interpersonal therapy', 'CT or IPT']","['social function and social joy', 'social anxiety', 'social avoidance', 'homework compliance']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",80.0,0.0147056,"Also better social function predicted less social avoidance, whereas more social anxiety predicted more self-focus.","[{'ForeName': 'Asle', 'Initials': 'A', 'LastName': 'Hoffart', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: asle.hoffart@modum-bad.no.'}, {'ForeName': 'Sverre Urnes', 'Initials': 'SU', 'LastName': 'Johnson', 'Affiliation': 'Research Institute, Modum Bad Psychiatric Center, Badeveien 287, N-3370, Vikersund, Norway; Department of Psychology, University of Oslo, PB 1094, Blindern, N-0317, Oslo, Norway. Electronic address: Sverre.Johnson@modum-bad.no.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102312']
2677,32966971,Exenatide and Renal Outcomes in Patients with Type 2 Diabetes and Diabetic Kidney Disease.,"BACKGROUND


Cardiovascular outcomes in clinical trials with type 2 diabetes mellitus (T2DM) patients have shown that glucagon-like peptide-1 receptor agonist can have a beneficial effect on the kidney. This trial aimed to assess the effects of exenatide on renal outcomes in patients with T2DM and diabetic kidney disease (DKD).
METHODS


We performed a randomized parallel study encompassing 4 general hospitals. T2DM patients with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 and macroalbuminuria, defined as 24-h urinary albumin excretion rate (UAER) >0.3 g/24 h were randomized 1:1 to receive exenatide twice daily plus insulin glargine (intervention group) or insulin lispro plus glargine (control group) for 24 weeks. The primary outcome was the UAER percentage change from the baseline after 24 weeks of intervention. The rates of hypoglycemia, adverse events (AEs), and change in eGFR during the follow-up were measured as safety outcomes.
RESULTS


Between March 2016 and April 2019, 92 patients were randomized and took at least 1 dose of the study drug. The mean age of the participants was 56 years. At baseline, the median UAER was 1,512.0 mg/24 h and mean eGFR was 70.4 mL/min/1.73 m2. After 24 weeks of treatment, the UAER percentage change was significantly lower in the intervention group than in the control group (p = 0.0255). Moreover, the body weight declined by 1.3 kg in the intervention group (the difference between the 2 groups was 2.7 kg, p = 0.0001). Compared to the control group, a lower frequency of hypoglycemia and more gastrointestinal AEs were observed in the intervention group.
CONCLUSION


Exenatide plus insulin glargine treatment for 24 weeks resulted in a reduction of albuminuria in T2DM patients with DKD.",2020,"After 24 weeks of treatment, the UAER percentage change was significantly lower in the intervention group than in the control group (p = 0.0255).","['type 2 diabetes mellitus (T2DM) patients', '92 patients', 'patients with T2DM and diabetic kidney disease (DKD', 'Between March 2016 and April 2019', '4 general hospitals', 'Patients with Type 2 Diabetes and Diabetic Kidney Disease', 'T2DM patients with DKD', 'T2DM patients with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 and macroalbuminuria, defined as 24-h urinary albumin excretion rate (UAER) >0.3 g/24 h']","['exenatide twice daily plus insulin glargine (intervention group) or insulin lispro plus glargine', 'Exenatide plus insulin glargine', 'exenatide', 'Exenatide']","['reduction of albuminuria', 'UAER percentage change', 'median UAER', 'safety outcomes', 'body weight', 'rates of hypoglycemia, adverse events (AEs), and change in eGFR', 'frequency of hypoglycemia and more gastrointestinal AEs', 'renal outcomes']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}, {'cui': 'C4068885', 'cui_str': '0.3'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",92.0,0.0767787,"After 24 weeks of treatment, the UAER percentage change was significantly lower in the intervention group than in the control group (p = 0.0255).","[{'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Huijie', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Meiping', 'Initials': 'M', 'LastName': 'Guan', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Shuyue', 'Initials': 'S', 'LastName': 'Sheng', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Mo', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, China.'}, {'ForeName': 'Mengchen', 'Initials': 'M', 'LastName': 'Zou', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jianlu', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, China.'}, {'ForeName': 'Xianyu', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Gugen', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology & Metabolism, Guangdong Second Provincial General Hospital, Guangzhou, China.'}, {'ForeName': 'Yaoming', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Endocrinology & Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China, xueyaoming999@126.com.'}]",American journal of nephrology,['10.1159/000510255']
2678,32967000,A robust and reproducible connectome fingerprint of ketamine is highly associated with the connectomic signature of antidepressants.,"Over the past decade, various N-methyl-D-aspartate modulators have failed in clinical trials, underscoring the challenges of developing novel rapid-acting antidepressants based solely on the receptor or regional targets of ketamine. Thus, identifying the effect of ketamine on the brain circuitry and networks is becoming increasingly critical. In this longitudinal functional magnetic resonance imaging study of data from 265 participants, we used a validated predictive model approach that allows the full assessment of brain functional connectivity, without the need for seed selection or connectivity summaries. First, we identified a connectome fingerprint (CFP) in healthy participants (Cohort A, n = 25) during intravenous infusion of a subanesthetic dose of ketamine, compared to normal saline. We then demonstrated the robustness and reproducibility of the discovered ketamine CFP in two separate healthy samples (Cohort B, n = 22; Cohort C, n = 18). Finally, we investigated the ketamine CFP connectivity at 1-week post treatment in major depressive disorder patients randomized to 8 weeks of sertraline or placebo (Cohort D, n = 200). We found a significant, robust, and reproducible ketamine CFP, consistent with reduced connectivity within the primary cortices and within the executive network, but increased connectivity between the executive network and the rest of the brain. Compared to placebo, the ketamine CFP connectivity changes at 1 week predicted response to sertraline at 8 weeks. In each of Cohorts A-C, ketamine significantly increased connectivity in a previously identified antidepressant CFP. Investigating the brain connectivity networks, we successfully identified a robust and reproducible ketamine biomarker that is related to the mechanisms of antidepressants.",2020,"We found a significant, robust, and reproducible ketamine CFP, consistent with reduced connectivity within the primary cortices and within the executive network, but increased connectivity between the executive network and the rest of the brain.","['healthy participants (Cohort A, n\u2009=\u200925) during', '265 participants', 'major depressive disorder patients']","['intravenous infusion of a subanesthetic dose of ketamine', 'ketamine', 'ketamine CFP', 'sertraline or placebo', 'placebo', 'connectome fingerprint (CFP', 'normal saline']","['ketamine CFP connectivity', 'ketamine CFP connectivity changes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C3494406', 'cui_str': 'Connectome'}, {'cui': 'C0016126', 'cui_str': 'Fingerprints'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C3494406', 'cui_str': 'Connectome'}, {'cui': 'C0016126', 'cui_str': 'Fingerprints'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",265.0,0.0674463,"We found a significant, robust, and reproducible ketamine CFP, consistent with reduced connectivity within the primary cortices and within the executive network, but increased connectivity between the executive network and the rest of the brain.","[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA. chadi.abdallah@bcm.edu.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Nemati', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Averill', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Fouda', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Deepak C', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'San Francisco VA Medical Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}, {'ForeName': 'Naomi R', 'Initials': 'NR', 'LastName': 'Driesen', 'Affiliation': 'Clinical Neuroscience Division, VA National Center for PTSD, West Haven, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00864-9']
2679,32967039,The gluten challenge is still the best option for children with a difficult diagnosis like non-coeliac gluten sensitivity.,"Gluten-related diseases, such as coeliac disease, wheat allergy and non-coeliac gluten sensitivity, are increasingly being diagnosed in children. Non-coeliac gluten sensitivity is an unclear and controversial entity, unlike the other two conditions. The recommended diagnosis is a double-blind, placebo-controlled gluten provocation test. Similarly, the test may be performed on children with suspected gluten-related diseases in very specific circumstances and under medical supervision. One example is patients who have started a gluten-free diet without undergoing a duodenal biopsy.",2020,"Gluten-related diseases, such as coeliac disease, wheat allergy and non-coeliac gluten sensitivity, are increasingly being diagnosed in children.","['children with a difficult diagnosis like non-coeliac gluten sensitivity', 'patients who have started a gluten-free diet without undergoing a duodenal biopsy', 'children with suspected gluten-related diseases in very specific circumstances and under medical supervision']",['placebo'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2711053', 'cui_str': 'Non-celiac gluten sensitivity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0399805', 'cui_str': 'Biopsy of duodenum'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0311418,"Gluten-related diseases, such as coeliac disease, wheat allergy and non-coeliac gluten sensitivity, are increasingly being diagnosed in children.","[{'ForeName': 'Chandra Sekhar', 'Initials': 'CS', 'LastName': 'Devulapalli', 'Affiliation': 'Norwegian Labour and Welfare Administration, Oslo, Norway.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15577']
2680,32967390,Efficacy of Intradiscal Ozone Therapy with or without Periforaminal Steroid Injection on Lumbar Disc Herniation: A Double-Blinded Controlled Study.,"BACKGROUND


Intradiscal ozone therapy, a minimally invasive technique, is used in patients that do not respond to standard conservative therapies for low back pain due to degenerative disc-induced lumbar disc herniation (LDH). Many studies on clinical efficacy lack a standardized injection method and are limited by inadequate study design.
OBJECTIVE


This study aimed to determine the efficacy of periforaminal steroid injection together with intradiscal ozone therapy.
STUDY DESIGN


A prospective, double-blinded, randomized controlled trial.
SETTING


A tertiary care center.
METHODS


This study was conducted in 65 patients with low back and leg pain caused by LDH. Group 1 received intradiscal ozone therapy (n = 35) and Group 2 received intradiscal ozone therapy with periforaminal steroid injection (n = 30). Patients were evaluated for pain using the visual analogue scale (VAS), for disability using Oswestry Disability Index (ODI), and for quality of life using the short form 36 health survey administered pre-injection and at one and 6 months post-injection. All procedures were performed under sterile conditions using C-arm fluoroscopy.
RESULTS


Significant improvements were observed in pain, disability, and quality of life in both groups post-treatment compared to pre-injection. Mean pre-injection VAS was not significantly different between the groups (VAS: 7.8 ± 1.1 for Group 1, 7.8 ± 1.2 for Group 2). VAS values at 6 months for Group 1 and Group 2 were as follows: 3.6 ± 2.4, 4.1 ± 1.6, respectively) (P < 0.001). Mean pre-injection ODI was not significantly different between the groups (ODI: 20.9 ± 9.6 for Group 1, 25.2 ± 10.3 for Group 2). ODI values at 6 months for Group 1 and Group 2 were as follows: 12.8 ± 9.2, 14.3 ± 7.2, respectively) (P < 0.001). However, there were no significant differences between the groups. Similarly, there was no significant difference between the 2 groups on any of these parameters.
LIMITATIONS


A limited number of patients and limited follow-up time.
CONCLUSION


This study showed that intradiscal ozone injection alone was sufficient to treat low back and leg pain caused by LDH and that periforaminal steroid injection does not provide additional benefit, which is contrary to the literature.",2020,"RESULTS


Significant improvements were observed in pain, disability, and quality of life in both groups post-treatment compared to pre-injection.","['65 patients with low back and leg pain caused by LDH', 'Lumbar Disc Herniation', 'A tertiary care center']","['intradiscal ozone therapy with periforaminal steroid injection', 'Intradiscal Ozone Therapy with or without Periforaminal Steroid Injection', 'intradiscal ozone injection alone', 'periforaminal steroid injection together with intradiscal ozone therapy', 'intradiscal ozone therapy']","['pain using the visual analogue scale (VAS), for disability using Oswestry Disability Index (ODI), and for quality of life', 'ODI values', 'pain, disability, and quality of life', 'VAS values', 'Mean pre-injection VAS', 'Mean pre-injection ODI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C1512934', 'cui_str': 'Intradiscal route'}, {'cui': 'C4727847', 'cui_str': 'Ozone therapy'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",65.0,0.0853782,"RESULTS


Significant improvements were observed in pain, disability, and quality of life in both groups post-treatment compared to pre-injection.","[{'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Ercalik', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Division of Pain Medicine, Sisli Hamidiye Etfal Training and Research Hospital, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kilic', 'Affiliation': '1Department of Physical Medicine and Rehabilitation, Division of Pain Medicine, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Turkey; 2Department of Neurosurgery, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Turkey.'}]",Pain physician,[]
2681,32963704,Dexmedetomidine Improves Lung Function by Promoting Inflammation Resolution in Patients Undergoing Totally Thoracoscopic Cardiac Surgery.,"Objective


Totally thoracoscopic cardiac surgery under cardiopulmonary bypass combined with one-lung ventilation has been identified as the trend in cardiac surgery. The aim of this study was to examine the effects of the selective  α   2  adrenergic receptor agonist dexmedetomidine on the pulmonary function of patients who underwent mitral valve surgery using the totally thoracoscopic technique.
Methods


Fifty-seven patients who underwent thoracoscopic mitral valve surgery between July 2019 and December 2019 were selected. The patients were randomly divided into the control (Con) group ( n  = 28) and the dexmedetomidine (DEX) group ( n  = 29) using the random number table method. Arterial blood gas analyses were performed, and the oxygenation (PaO 2 /FiO 2 ) and respiratory indexes (P(A-a)O/PaO 2 ) were calculated 5 min after tracheal intubation (T1), 2 h after operation (T2), 6 h after operation (T3), and 24 h after operation (T4). Moreover, the serum cytokines interleukin-6 (IL-6), tumor necrosis factor- α  (TNF- α ), and intercellular adhesion molecule-1 (ICAM-1) were detected using the enzyme-linked immunosorbent method at all time points. Chest radiography was performed 24 h after surgery. Peripheral blood samples were collected before and after the operation for a complete hemogram. Additionally, the procalcitonin concentration was measured and recorded when the patients were transported to the intensive care unit (ICU). The postoperative extubation time, length of ICU stay, and pulmonary infection rate were also recorded.
Results


Inflammatory reaction after surgery was evident. However, the inflammatory cytokines IL-6, TNF- α , and ICAM-1 in the DEX group were lower than those in the Con group after surgery (T2 to T4;  P  < 0.05). Neutrophil counts and procalcitonin concentration were higher in the Con group than in the DEX group ( P  < 0.05). In addition, in the DEX group, pulmonary exudation on chest radiography was lower, and pulmonary function, as shown by an increase in oxidation index and decrease in the respiratory index, improved after surgery ( P  < 0.05). Moreover, the duration of mechanical ventilation in the Con group was 3.4 h longer than that in the DEX group.
Conclusion


Dexmedetomidine has a protective effect on pulmonary function in patients undergoing mitral valve surgery using a totally video-assisted thoracoscopic technique, which may be related to a reduction in the concentration of inflammatory cytokines in the early perioperative period.",2020,Neutrophil counts and procalcitonin concentration were higher in the Con group than in the DEX group ( P  < 0.05).,"['Methods\n\n\nFifty-seven patients who underwent thoracoscopic mitral valve surgery between July 2019 and December 2019 were selected', 'patients who underwent mitral valve surgery using the totally thoracoscopic technique', 'patients undergoing mitral valve surgery', 'Patients Undergoing Totally Thoracoscopic Cardiac Surgery']","['DEX', 'Chest radiography', 'Dexmedetomidine', 'selective  α   2  adrenergic receptor agonist dexmedetomidine', 'dexmedetomidine (DEX', 'thoracoscopic cardiac surgery under cardiopulmonary bypass combined with one-lung ventilation']","['duration of mechanical ventilation', 'respiratory index', 'postoperative extubation time, length of ICU stay, and pulmonary infection rate', 'Peripheral blood samples', 'pulmonary function', 'pulmonary exudation on chest radiography', 'Neutrophil counts and procalcitonin concentration', 'oxidation index', 'inflammatory cytokines IL-6, TNF- α , and ICAM-1', 'procalcitonin concentration', 'serum cytokines interleukin-6 (IL-6), tumor necrosis factor- α  (TNF- α ), and intercellular adhesion molecule-1 (ICAM-1']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0001648', 'cui_str': 'Adrenergic receptor agonist'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0451423', 'cui_str': 'Respiratory index'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",57.0,0.0182755,Neutrophil counts and procalcitonin concentration were higher in the Con group than in the DEX group ( P  < 0.05).,"[{'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': ""Department of Anesthesiology, Cardiovascular Institute of Guangdong Province, Guangdong Provincial People's Hospital, Guangzhou, Guangdong 510030, China.""}, {'ForeName': 'Mintai', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': ""Department of Anesthesiology, Cardiovascular Institute of Guangdong Province, Guangdong Provincial People's Hospital, Guangzhou, Guangdong 510030, China.""}, {'ForeName': 'Hongqian', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ""Department of Anesthesiology, Cardiovascular Institute of Guangdong Province, Guangdong Provincial People's Hospital, Guangzhou, Guangdong 510030, China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Clinical Laboratory, Guangdong Provincial People's Hospital Zhuhai Hospital, Zhuhai Golden Bay Center Hospital, Zhuhai, Guangdong 519000, China.""}, {'ForeName': 'Qingshi', 'Initials': 'Q', 'LastName': 'Zeng', 'Affiliation': ""Department of Anesthesiology, Cardiovascular Institute of Guangdong Province, Guangdong Provincial People's Hospital, Guangzhou, Guangdong 510030, China.""}]",Oxidative medicine and cellular longevity,['10.1155/2020/8638301']
2682,32963754,Effects of Vestibular Rehabilitation on Fatigue and Activities of Daily Living in People with Parkinson's Disease: A Pilot Randomized Controlled Trial Study.,"One of the most disabling nonmotor symptoms in persons with Parkinson's disease is fatigue, which can decrease the quality of life by restricting the function and activities of daily living (ADL). Nonetheless, sufficient evidence for treating fatigue, including drug or nondrug treatment, is not available. In this study, we evaluated the probable effects of vestibular rehabilitation on fatigue and ADL in patients with Parkinson's disease.  Methods . This was a single-blind clinical trial study in which patients with Parkinson's disease voluntarily participated based on the inclusion and exclusion criteria. The patients were randomly assigned to the case and control groups. The case group received 24 sessions of vestibular rehabilitation protocol, and conventional rehabilitation was performed in the control group (i.e., 3 sessions each week, each lasted about 60 minutes). Both groups were also given fatigue management advice. Fatigue was measured by the Parkinson Fatigue Scale (PFS) and the Modified Fatigue Impact Scale (MFIS). ADL was measured by the Functional Independence Measure (FIM). All changes were measured from the baseline at the completion of the intervention.  Results . Both fatigue ( P  ≤ 0.001) and ADL ( P  ≤ 0.001) improved significantly more in the vestibular intervention group than in the control one.  Conclusion . Vestibular rehabilitation may improve fatigue and ADL and therefore can be used as an effective intervention for patients with Parkinson's disease, which was also found to be well tolerated.",2020,Both fatigue ( P  ≤ 0.001) and ADL ( P  ≤ 0.001) improved significantly more in the vestibular intervention group than in the control one.  ,"[""persons with Parkinson's disease"", ""patients with Parkinson's disease voluntarily participated based on the inclusion and exclusion criteria"", ""patients with Parkinson's disease"", ""People with Parkinson's Disease""]","['Vestibular Rehabilitation', 'Vestibular rehabilitation', 'vestibular rehabilitation', '24 sessions of vestibular rehabilitation protocol, and conventional rehabilitation']","['Functional Independence Measure (FIM', 'ADL', 'Parkinson Fatigue Scale (PFS) and the Modified Fatigue Impact Scale (MFIS', 'fatigue and ADL', 'Fatigue and Activities of Daily Living', 'Fatigue']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}]",,0.0350547,Both fatigue ( P  ≤ 0.001) and ADL ( P  ≤ 0.001) improved significantly more in the vestibular intervention group than in the control one.  ,"[{'ForeName': 'Amirabas', 'Initials': 'A', 'LastName': 'Abasi', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Raji', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurology, Warren Alpert School of Medicine at Brown University, Providence, RI, USA.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Hadian', 'Affiliation': 'School of Rehabilitation, Brain and Spinal Injury Research Center (BASIR), Institute of Neuroscience, Tehran University of Medical Sciences (TUMS), International Campus TUMS, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Hoseinabadi', 'Affiliation': 'Department of Audiology, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somaye', 'Initials': 'S', 'LastName': 'Abbasi', 'Affiliation': 'Department of Occupational Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Baghestani', 'Affiliation': 'Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Parkinson's disease,['10.1155/2020/8624986']
2683,32963795,Effectiveness of a peer-led adolescent mental health intervention on HIV virological suppression and mental health in Zimbabwe: protocol of a cluster-randomised trial.,"Background


Adolescents living with HIV (ALHIV) experience a high burden of mental health disorder which is a barrier to antiretroviral therapy adherence. In Zimbabwe, trained, mentored peer supporters living with HIV (Community Adolescent Treatment Supporters - CATS) have been found to improve adherence, viral suppression and psychosocial well-being among ALHIV. The Friendship Bench is the largest integrated mental health programme in Africa. We hypothesise that combining the CATS programme and Friendship Bench will improve mental health and virological suppression among ALHIV compared with the CATS programme alone.
Methods


We will conduct a cluster-randomised controlled trial in 60 clinics randomised 1:1 in five provinces. ALHIV attending the control arm clinics will receive standard CATS support and clinic support following the Ministry of Health guidelines. Those attending the intervention arm clinics will receive Friendship Bench problem-solving therapy, delivered by trained CATS. Participants with the signs of psychological distress will be referred to the clinic for further assessment and management. The primary outcome is HIV virological failure (≥1000 copies/ml) or death at 48 weeks. Secondary outcomes include the proportion of adolescents with common mental disorder symptoms (defined as Shona Symptom Questionnaire (SSQ-14) score ≥8), proportion with depression symptoms (defined as Patient Health Questionnaire (PHQ-9) score ≥11), symptom severity (mean SSQ-14 and PHQ-9 scores) and EQ-5D score for health-related quality of life.
Conclusions


This trial evaluates the effectiveness of peer-delivery of mental health care on mental health and HIV viral load among ALHIV. If effective this intervention has the potential to be scaled-up to improve these outcomes.Trial registration: PACTR201810756862405. 08 October 2018.",2020,This trial evaluates the effectiveness of peer-delivery of mental health care on mental health and HIV viral load among ALHIV.,"['60 clinics randomised 1:1 in five provinces', '\n\n\nAdolescents living with HIV (ALHIV) experience a high burden of mental health disorder', 'Participants with the signs of psychological distress']","['peer-led adolescent mental health intervention', 'peer-delivery of mental health care', 'Friendship Bench problem-solving therapy, delivered by trained CATS']","['proportion of adolescents with common mental disorder symptoms (defined as Shona Symptom Questionnaire (SSQ-14) score ≥8), proportion with depression symptoms (defined as Patient Health Questionnaire (PHQ-9) score ≥11), symptom severity (mean SSQ-14 and PHQ-9 scores) and EQ-5D score for health-related quality of life', 'HIV virological failure (≥1000 copies/ml) or death', 'HIV virological suppression and mental health', 'mental health and virological suppression']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0036989', 'cui_str': 'Shona'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",60.0,0.238439,This trial evaluates the effectiveness of peer-delivery of mental health care on mental health and HIV viral load among ALHIV.,"[{'ForeName': 'Silindweyinkosi', 'Initials': 'S', 'LastName': 'Chinoda', 'Affiliation': 'Friendship Bench, Harare, Zimbabwe.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Mutsinze', 'Affiliation': 'Africaid, Harare, Zimbabwe.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Simms', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Rhulani', 'Initials': 'R', 'LastName': 'Beji-Chauke', 'Affiliation': 'Friendship Bench, Harare, Zimbabwe.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Verhey', 'Affiliation': 'Friendship Bench, Harare, Zimbabwe.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': ""Childrens' Investment Fund Foundation, London, UK.""}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Barker', 'Affiliation': ""Childrens' Investment Fund Foundation, London, UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Mugurungi', 'Affiliation': 'AIDS & TB Unit, Ministry of Health and Child Care, Zimbabwe.'}, {'ForeName': 'Tsitsi', 'Initials': 'T', 'LastName': 'Apollo', 'Affiliation': 'AIDS & TB Unit, Ministry of Health and Child Care, Zimbabwe.'}, {'ForeName': 'Epiphany', 'Initials': 'E', 'LastName': 'Munetsi', 'Affiliation': 'Friendship Bench, Harare, Zimbabwe.'}, {'ForeName': 'Dorcas', 'Initials': 'D', 'LastName': 'Sithole', 'Affiliation': 'Ministry of Health and Child Care, Zimbabwe and Mental Health Services, Zimbabwe.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Dixon', 'Initials': 'D', 'LastName': 'Chibanda', 'Affiliation': 'Friendship Bench, Harare, Zimbabwe.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Willis', 'Affiliation': 'Africaid, Harare, Zimbabwe.'}]","Global mental health (Cambridge, England)",['10.1017/gmh.2020.14']
2684,32963985,Comparison of the Efficacy of Honey Gel and Clotrimazole Cream in the Treatment of Vaginal Candidiasis Signs: A Randomized Clinical Trial.,"Introduction:  Due to the increasing resistance to synthetic antifungal drugs, the use of drugs with a natural origin, with low side effects and low prices is a priority. This study was performed to evaluate the effect of topical honey gel and clotrimazole cream in treatment of signs of vaginal candidiasis.  Methods:  This randomized clinical trial was conducted to evaluate the topical use of honey and clotrimazole in the signs of vulvovaginal candidiasis in clinics and medical centers in Tabriz. The study was performed on 106 non-pregnant women (18 to 45 years old) who had clinical signs of candidiasis. Patients were randomly divided into two groups receiving honey gel and clotrimazole vaginal cream (53 people per group). Each group was treated for 8 days. Before, 4, and 8 days after the intervention, patients recorded the sings of disease and possible side effects of drugs using a researcher-made questionnaire. The results were analyzed using SPSS software ver. 22. Inter-group comparison was carried out using McNemar, Cochran Q and independent t tests. P value < 0.05 was considered statistically significant.  Results:  sults: In the three evaluation periods, a significant reduction in the sings was observed compared to the before starting of treatment regimes. The results of the cultures were similar and there was no significant difference between the two honey gel and clotrimazole cream groups.  Conclusion:  Our results may suggest that honey gel could have promising benefits in the treatment of vulvovaginal candidiasis as the main drug or as an adjunct to other antifungal drugs.",2020,The results of the cultures were similar and there was no significant difference between the two honey gel and clotrimazole cream groups.  ,"['vulvovaginal candidiasis in clinics and medical centers in Tabriz', '106 non-pregnant women (18 to 45 years old) who had clinical signs of candidiasis', 'Vaginal Candidiasis Signs']","['topical honey gel and clotrimazole cream', 'Honey Gel and Clotrimazole Cream', 'clotrimazole cream', 'honey gel and clotrimazole vaginal cream', 'honey and clotrimazole']",[],"[{'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}, {'cui': 'C0006852', 'cui_str': 'Candidiasis of vagina'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1251893', 'cui_str': 'Clotrimazole Topical Cream'}, {'cui': 'C1251895', 'cui_str': 'Clotrimazole Vaginal Cream'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}]",[],106.0,0.0283887,The results of the cultures were similar and there was no significant difference between the two honey gel and clotrimazole cream groups.  ,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Seifinadergoli', 'Affiliation': 'Department of Midwifery & Reproductive Health, School of Nursing & Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nahidi', 'Affiliation': 'Department of Midwifery & Reproductive Health, School of Nursing & Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdolrasoul', 'Initials': 'A', 'LastName': 'Safaiyan', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Health, Road Traffic Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Javadzadeh', 'Affiliation': 'Biotechnology Research Center, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Eteraf Oskouei', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of caring sciences,['10.34172/jcs.2020.024']
2685,32963989,Personalised exhaled nitric oxygen fraction ( F   ENO )-driven asthma management in primary care: a  F   ENO  subgroup analysis of the ACCURATE trial.,"Background


The aim of this study was to identify patients who benefit most from exhaled nitric oxide fraction ( F   ENO )-driven asthma management in primary care, based on prespecified subgroups with different levels of  F   ENO .
Methods


We used data from 179 adults with asthma from a 12-month primary care randomised controlled trial with 3-monthly assessments of  F   ENO , asthma control, medication usage, costs of medication, severe asthma exacerbations and quality of life. In the original study, patients were randomised to either a symptom-driven treatment strategy (controlled asthma (Ca) strategy) or a  F   ENO +symptom-driven strategy (FCa). In both groups, patients were categorised by their baseline level of  F   ENO  as low (<25 ppb), intermediate (25-50 ppb) and high (>50 ppb). At 12 months, we compared, for each prespecified  F   ENO  subgroup, asthma control, asthma-related quality of life, medication usage, and costs of medication between the Ca and FCa strategy.
Results


We found a difference between the Ca and FCa strategy for the mean dosage of beclomethasone strategy of 223 µg (95% CI 6-439), p=0.04) and for the total costs of asthma medication a mean reduction of US$159 (95% CI US$33-285), p=0.03) in patients with a low baseline  F   ENO  level. No differences were found for asthma control, severe asthma exacerbations and asthma-related quality of life in patients with a low baseline  F   ENO  level. Furthermore, in patients with intermediate or high level of  F   ENO , no differences were found.
Conclusions


In primary care,  F   ENO -driven asthma management is effective in patients with a low  F   ENO  level, for whom it is possible to down-titrate medication, while preserving asthma control and quality of life.",2020,"No differences were found for asthma control, severe asthma exacerbations and asthma-related quality of life in patients with a low baseline  F   ENO  level.","['patients who benefit most from exhaled nitric oxide fraction ( F   ENO )-driven asthma management in primary care, based on prespecified subgroups with different levels of  F   ENO ', 'primary care', '179 adults with asthma from a 12-month primary care']","['symptom-driven treatment strategy (controlled asthma (Ca) strategy) or a  F   ENO +symptom-driven strategy (FCa', 'beclomethasone', 'Personalised exhaled nitric oxygen fraction ( F   ENO )-driven asthma management']","['asthma control, severe asthma exacerbations and asthma-related quality of life', 'asthma control, asthma-related quality of life, medication usage, and costs of medication between the Ca and FCa strategy', 'total costs of asthma medication', 'severe asthma exacerbations and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0016712', 'cui_str': ""Freund's adjuvant""}, {'cui': 'C0004905', 'cui_str': 'Beclomethasone'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0016712', 'cui_str': ""Freund's adjuvant""}, {'cui': 'C0439810', 'cui_str': 'Total'}]",179.0,0.121079,"No differences were found for asthma control, severe asthma exacerbations and asthma-related quality of life in patients with a low baseline  F   ENO  level.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Boer', 'Affiliation': 'Dept of Biomedical Data Sciences, Section of Medical Decision Making, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Persijn J', 'Initials': 'PJ', 'LastName': 'Honkoop', 'Affiliation': 'Dept of Biomedical Data Sciences, Section of Medical Decision Making, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Rik J B', 'Initials': 'RJB', 'LastName': 'Loijmans', 'Affiliation': 'Dept of General Practice, Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Jiska B', 'Initials': 'JB', 'LastName': 'Snoeck-Stroband', 'Affiliation': 'Dept of Biomedical Data Sciences, Section of Medical Decision Making, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Willem J J', 'Initials': 'WJJ', 'LastName': 'Assendelft', 'Affiliation': 'Dept of Primary and Community Care, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Tjard R J', 'Initials': 'TRJ', 'LastName': 'Schermer', 'Affiliation': 'Dept of Primary and Community Care, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Jacob K', 'Initials': 'JK', 'LastName': 'Sont', 'Affiliation': 'Dept of Biomedical Data Sciences, Section of Medical Decision Making, Leiden University Medical Centre, Leiden, The Netherlands.'}]",ERJ open research,['10.1183/23120541.00351-2019']
2686,32963990,Does an mHealth system reduce health service use for asthma?,"Background


Breathe is a mobile health (mHealth) application developed for the self-management of asthma in adults. There is evidence to suggest that mHealth interventions can be used for asthma control; however, their effects on the use of health services remain poorly understood. We sought to determine whether Breathe reduces health services use amongst asthma patients who used the app compared to controls who did not.
Methods


The impact of Breathe on health services use was estimated using a quasi-experimental approach. Two groups of subjects who had participated in a previous randomised clinical trial were included: an intervention group of asthma patients who used the app for 12 months, and a group of controls who did not use the app but received equivalent quality asthma care. A third, external control group of asthma patients were matched to the intervention participants. Generalised linear mixed models were used to determine relative changes in rates of asthma hospitalisations, emergency department (ED) visits, outpatient physician visits and completion of pulmonary function tests (PFTs) over time.
Results


A total of 677 individuals with asthma were included in the study: 132 in the intervention group, and 149 and 396 in the internal and external control groups, respectively. There were no statistically significant differences in the change of asthma hospitalisations, ED visits, physician office visits or completion of PFTs between the intervention group and either control group.
Conclusions


Use of the Breathe app is not associated with changes in health services use in adults with asthma.",2020,"There were no statistically significant differences in the change of asthma hospitalisations, ED visits, physician office visits or completion of PFTs between the intervention group and either control group.
","['adults with asthma', 'asthma in adults', 'Two groups of subjects who had participated in a previous randomised clinical trial were included: an intervention group of asthma patients who used the app for 12\u2005months, and a group of controls who did not use the app but received equivalent quality asthma care', 'asthma patients who used the app compared to controls who did not', '677 individuals with asthma were included in the study: 132 in the intervention group, and 149 and 396 in the internal and external control groups, respectively']",[],"['change of asthma hospitalisations, ED visits, physician office visits or completion of PFTs', 'rates of asthma hospitalisations, emergency department (ED) visits, outpatient physician visits and completion of pulmonary function tests (PFTs) over time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0031834', 'cui_str': ""Physician's Office""}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",677.0,0.0357145,"There were no statistically significant differences in the change of asthma hospitalisations, ED visits, physician office visits or completion of PFTs between the intervention group and either control group.
","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'To', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'M Diane', 'Initials': 'MD', 'LastName': 'Lougheed', 'Affiliation': 'ICES, Toronto, ON, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'McGihon', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Jingqin', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Division of Respirology, Dept of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Licskai', 'Affiliation': 'Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.'}]",ERJ open research,['10.1183/23120541.00340-2019']
2687,32963999,Response to mepolizumab treatment is sustained across 4-weekly dosing periods.,"Background


Mepolizumab (100 mg delivered  s.c.  every 4 weeks) is indicated for add-on maintenance treatment for patients with severe eosinophilic asthma. Mepolizumab has been shown to reduce exacerbations and the requirement for daily oral corticosteroids, and improve asthma control and symptoms. However, data on the durability of the response to mepolizumab during dosing periods are limited. The aim of this study was to investigate the efficacy profile in patients with severe eosinophilic asthma over the 4-weekly dosing period for various fixed mepolizumab doses.
Methods


This was a  post hoc  analysis of data from the phase IIb/III DREAM study. Patients ≥12 years of age with severe eosinophilic asthma were randomised (1:1:1:1) to receive intravenous mepolizumab 75 mg (equivalent to 100 mg  s.c.),  250 mg, 750 mg or placebo, plus standard of care, every 4 weeks for 52 weeks. The number of exacerbations and eDiary data (peak expiratory flow, rescue medication use and symptom scores) from two periods in each 4-weekly dosing interval (days 1-14 and 15-28) over the 52-week treatment period were analysed.
Findings


eDiary data and the proportion of patients experiencing ≥1 exacerbation were similar during the first and second 2 weeks of a dosing period across all mepolizumab doses.
Interpretation


These results demonstrate that the response to mepolizumab is sustained over the 4-weekly dosing period with no differences across a 10-fold dose range and supports the use of the current mepolizumab dosing regimen in patients with severe eosinophilic asthma.",2020,"Findings


eDiary data and the proportion of patients experiencing ≥1 exacerbation were similar during the first and second 2 weeks of a dosing period across all mepolizumab doses.
","['patients with severe eosinophilic asthma', 'Patients ≥12\u2005years of age with severe eosinophilic asthma', 'patients with severe eosinophilic asthma over the 4-weekly dosing period for various fixed mepolizumab doses']","['intravenous mepolizumab 75 mg (equivalent to 100 mg  s.c.),  250 mg, 750 mg or placebo', '\n\n\nMepolizumab (100 mg delivered  s.c', 'Mepolizumab', 'mepolizumab']","['number of exacerbations and eDiary data (peak expiratory flow, rescue medication use and symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.129169,"Findings


eDiary data and the proportion of patients experiencing ≥1 exacerbation were similar during the first and second 2 weeks of a dosing period across all mepolizumab doses.
","[{'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Respiratory Medicine Unit and Oxford Respiratory NIHR BRC, Nuffield Dept of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'Genomics and Precision Medicine, University of Arizona College of Medicine, Tucson, AZ, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Dept of Pulmonary Medicine, Mainz University Hospital, Mainz, Germany.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Chanez', 'Affiliation': 'Clinique des bronches allergies et sommeil, INSERM C2VN Center and CIC Nord APHM, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Elisabeth H', 'Initials': 'EH', 'LastName': 'Bel', 'Affiliation': 'Dept of Respiratory Medicine, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Howarth', 'Affiliation': 'Global Medical Franchise, GSK, Brentford, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bratton', 'Affiliation': 'Clinical Statistics, GSK, Stockley Park, UK.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Albers', 'Affiliation': 'Respiratory Medical Franchise, GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Yancey', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.'}]",ERJ open research,['10.1183/23120541.00068-2020']
2688,32964296,"Comparative prospective study of early outcomes after osteosynthesis with locked intramedullary nailing or plating for closed femoral shaft fractures at the National Orthopaedic Hospital Enugu, Nigeria.","AIM OF THE STUDY


This was to compare the early outcome of closed femoral shaft fractures treated with locked intramedullary nailing and plating at the National Orthopaedic Hospital Enugu.
METHODS


The study was a prospective study over 12-month period at the National Orthopaedic Hospital Enugu. Ethical clearance was obtained from the hospital ethical committee. Written informed consent was obtained from all prospectively recruited participants. Patients who met the inclusion criteria were randomly selected by simple balloting into either intramedullary nailing group or plating group. The patients were evaluated at presentation and postoperatively within 48 hours, then at two weeks, six weeks, 12 weeks and 18 weeks, respectively. Participants were evaluated using Thoresen criteria.
RESULTS


A total of 52 femoral shaft fractures in 50 patients were included and analysed using SPSS version 20.0. Bone union was obtained in all the patients in the intramedullary nailing group at 12 weeks and in 84.6% patients in the plating group between 12 and 18 weeks. The overall wound infection rate was 11.5% in the locked intramedullary group and 7.7% in the plating group. Similarly, the overall limb length discrepancy was 11.5% in the locked intramedullary nailing group and 19.2% in the plating group. Based on the Thoresen criteria, good to excellent outcome was achieved in 65.4% of patients in the locked intramedullary nailing group.
DISCUSSION


The patients in both groups were evaluated clinically, radiologically and functionally based on the Thoresen criteria and significantly higher number of patients in the intramedullary nailing group (17; 65.4%) than the plating group had good to excellent outcome (x 2  = 9.734; p = 0.020).
CONCLUSION


The early outcome of treatment of closed femoral shaft fractures in adults is significantly better following locked intramedullary nailing than plating.",2020,The early outcome of treatment of closed femoral shaft fractures in adults is significantly better following locked intramedullary nailing than plating.,"['closed femoral shaft fractures at the National Orthopaedic Hospital Enugu, Nigeria', 'Patients who met the inclusion criteria', '52 femoral shaft fractures in 50 patients']","['intramedullary nailing', 'osteosynthesis with locked intramedullary nailing or plating', 'locked intramedullary nailing', 'intramedullary nailing group or plating group', 'locked intramedullary nailing and plating']","['overall wound infection rate', 'Ethical clearance', 'closed femoral shaft fractures', 'overall limb length discrepancy', 'Bone union']","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0272753', 'cui_str': 'Fracture of shaft of femur'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0272753', 'cui_str': 'Fracture of shaft of femur'}, {'cui': 'C0410785', 'cui_str': 'Limb length discrepancy'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",52.0,0.0225594,The early outcome of treatment of closed femoral shaft fractures in adults is significantly better following locked intramedullary nailing than plating.,"[{'ForeName': 'Remigius T', 'Initials': 'RT', 'LastName': 'Ekwunife', 'Affiliation': 'Department Of Orthopaedics & Traumatology, National Orthopedic Hospital, Enugu, Nigeria. remyclassic@yahoo.com.'}, {'ForeName': 'Emmanuel C', 'Initials': 'EC', 'LastName': 'Iyidobi', 'Affiliation': 'Department Of Orthopaedics & Traumatology, National Orthopedic Hospital, Enugu, Nigeria.'}, {'ForeName': 'Ugochukwu N', 'Initials': 'UN', 'LastName': 'Enweani', 'Affiliation': 'City Specialist Hospital, Enugu, Nigeria.'}, {'ForeName': 'Cajetan U', 'Initials': 'CU', 'LastName': 'Nwadinigwe', 'Affiliation': 'Department Of Orthopaedics & Traumatology, National Orthopedic Hospital, Enugu, Nigeria.'}, {'ForeName': 'Charles I', 'Initials': 'CI', 'LastName': 'Okwesili', 'Affiliation': 'Department of Surgery, College of Medicine, University of Nigeria, Enugu Campus, Nsukka, Nigeria.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Ekwedigwe', 'Affiliation': 'Department of Surgery, Enugu State University Teaching Hospital Parklane, Enugu, Nigeria.'}, {'ForeName': 'Bernard O', 'Initials': 'BO', 'LastName': 'Obande', 'Affiliation': 'Department of Surgery, Federal Medical Center, Makurdi Benue State, Makurdi, Nigeria.'}]",International orthopaedics,['10.1007/s00264-020-04746-z']
2689,32964308,Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity.,"PURPOSE


Repetitive Transcranial Magnetic Stimulation (rTMS) has been demonstrated to be effective in body weight control in individuals with obesity. Most clinical trials on rTMS provided a reassuring safety profile. In the present work, we present an extensive analysis on both severe and mild Adverse Events (AEs) in obese individuals treated with rTMS.
METHODS


We examined the intensity, duration, correlation with the treatment, up to 1 year after the end of rTMS treatment.
RESULTS


Descriptive analysis included a total of 63 subjects undergoing a 5-week deep rTMS experimental treatment for obesity (age 48.3 ± 10.4 years; BMI 36.3 ± 4.4 kg/m 2 ): 31 patients were treated with high-frequency rTMS (HF), 13 with low-frequency rTMS (LF), and 19 were sham treated (Sham). Thirty-two subjects (50.8%) reported a total of 52 AEs, including mainly moderate (51.9%) events. The most frequently reported side effects were headaches of moderate intensity (40.4%) and local pain/discomfort (19.2%) and resulted significantly more frequent in HF group compared to other groups (p < 0.05). No significant differences among groups were found for the other reported AEs: drowsiness, insomnia, paresthesia, vasovagal reactions, hypertensive crisis. No AEs potentially related to the rTMS arised up to 1 year from the end of the treatment.
CONCLUSIONS


This is the first comprehensive safety analysis in obese patients treated with rTMS. The analysis did not reveal any unexpected safety concerns. Only headaches and local pain/discomfort have been significantly more frequent in the HF group, confirming the good tolerability of rTMS even in the obese population potentially more susceptible to side effects of brain stimulation.",2020,"No significant differences among groups were found for the other reported AEs: drowsiness, insomnia, paresthesia, vasovagal reactions, hypertensive crisis.","['obese patients treated with rTMS', 'obese individuals treated with rTMS', 'individuals with obesity', 'obesity', '63 subjects undergoing a 5-week deep rTMS experimental treatment for obesity (age 48.3\u2009±\u200910.4\u2009years; BMI 36.3\u2009±\u20094.4\u2009kg/m 2 ): 31 patients were treated with high-frequency rTMS (HF), 13 with low-frequency rTMS (LF), and 19 were sham treated (Sham']","['rTMS', 'Repetitive Transcranial Magnetic Stimulation (rTMS', 'deep transcranial magnetic stimulation']","['AEs: drowsiness, insomnia, paresthesia, vasovagal reactions, hypertensive crisis', 'Safety and tolerability', 'local pain/discomfort', 'headaches of moderate intensity', 'headaches and local pain/discomfort']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191376', 'cui_str': '10.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0042420', 'cui_str': 'Vasovagal syncope'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]",63.0,0.056414,"No significant differences among groups were found for the other reported AEs: drowsiness, insomnia, paresthesia, vasovagal reactions, hypertensive crisis.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ferrulli', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Via Mangiagalli 31, 20133, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Massarini', 'Affiliation': 'Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Via Milanese 300, 20099, Sesto San Giovanni (MI), Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Macrì', 'Affiliation': 'Department of Endocrinology, Nutrition and Metabolic Diseases, IRCCS MultiMedica, Via Milanese 300, 20099, Sesto San Giovanni (MI), Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Luzi', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Via Mangiagalli 31, 20133, Milan, Italy. livio.luzi@multimedica.it.'}]",Endocrine,['10.1007/s12020-020-02496-x']
2690,32964356,"Letter to the editor regarding ""A randomized controlled trial: comparing extracorporeal shock wave therapy versus local corticosteroid injection for the treatment of carpal tunnel syndrome"".",,2020,,['carpal tunnel syndrome'],['extracorporeal shock wave therapy versus local corticosteroid injection'],[],"[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",[],,0.0526131,,"[{'ForeName': 'Cong-Xian', 'Initials': 'CX', 'LastName': 'Chen', 'Affiliation': ""Department of Ultrasound, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Zeng', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': ""Department of Ultrasound, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China. lois1@163.com.""}]","Medical oncology (Northwood, London, England)",['10.1007/s12032-020-01418-1']
2691,32964377,Cognitive Behavioral Therapy and Mindfulness-Based Cognitive Therapy in Children and Adolescents with Type 2 Diabetes.,"PURPOSE OF REVIEW


Among adults with type 2 diabetes (T2D), cognitive behavioral therapy (CBT), acceptance and commitment therapy, and mindfulness interventions have demonstrated improvement in depression, anxiety, and glycemic control. We assessed whether these treatment modalities have shown usefulness in adolescents with T2D or at risk for T2D.
RECENT FINDINGS


Data are limited on the use of the abovementioned therapeutic interventions and include only adolescent girls at risk for T2D. CBT was as useful as health education sessions. At 1 year, greater decreases in depression, insulin resistance, and BMI were observed in girls randomized to mindfulness compared with CBT groups. Given the positive outcome of mindfulness intervention in adults and in adolescent girls at risk for T2D, future studies should involve males at risk for T2D, and adolescents diagnosed with T2D. Longer interventions and booster meetings for maintenance should be studied.",2020,"At 1 year, greater decreases in depression, insulin resistance, and BMI were observed in girls randomized to mindfulness compared with CBT groups.","['adolescents with T2D or at risk for T2D', 'Children and Adolescents with Type 2 Diabetes', 'adults with type 2 diabetes (T2D', 'adults and in adolescent girls']","['Cognitive Behavioral Therapy and Mindfulness-Based Cognitive Therapy', 'mindfulness intervention', 'cognitive behavioral therapy (CBT']","['depression, insulin resistance, and BMI', 'depression, anxiety, and glycemic control']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0188652,"At 1 year, greater decreases in depression, insulin resistance, and BMI were observed in girls randomized to mindfulness compared with CBT groups.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Pinhas-Hamiel', 'Affiliation': ""Pediatric Endocrine and Diabetes Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel. orit.hamiel@sheba.health.gov.il.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hamiel', 'Affiliation': 'Baruch Ivcher School of Psychology, Herzlyia Inter-Disciplinary Center, Herzliya, Israel.'}]",Current diabetes reports,['10.1007/s11892-020-01345-5']
2692,32964381,Efficacy of Intensive Cerebellar Intermittent Theta Burst Stimulation (iCiTBS) in Treatment-Resistant Schizophrenia: a Randomized Placebo-Controlled Study.,"Trans-cranial magnetic stimulation (TMS) can noninvasively modulate specific brain regions to dissipate symptoms in treatment-resistant schizophrenia (TRS). Citing impaired resting state connectivity between cerebellum and prefrontal cortex in schizophrenia, we aimed to study the effect of intermittent theta burst stimulation (iTBS) targeting midline cerebellum in TRS subjects on a randomized rater blinded placebo control study design. In this study, 36 patients were randomly allocated (using block randomization method) to active and sham iTBS groups. They were scheduled to receive ten iTBS sessions, two per day (total of 1200 pulses) for 5 days in a week. The Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale (BPRS), Schizophrenia Cognition Rating Scale (SCoRS), Simpson-Angus Extrapyramidal Side Effects Scale (SAS), and Clinical Global Impression (CGI) were assessed at baseline, after last session, and at 2 weeks post-rTMS. Thirty patients (16 and 14 in active and sham groups) completed the study. Intention to treat analysis (ITT) using mixed (growth curve) model analysis was conducted. No significant group (active vs sham) × time (pretreatment-end of 10th session-end of 2 weeks post iTBS) interaction was found for any of the variable. No major side effects were reported. Our study fails to show a significant effect of intensive cerebellar iTBS (iCiTBS) on schizophrenia psychopathology, cognitive functions, and global improvement, compared with sham stimulation, in treatment resistant cases. However, we conclude that it is safe and well tolerated. Trials using better localization technique with large sample, longer duration, and better dosing protocols are needed.",2020,No major side effects were reported.,"['Treatment-Resistant Schizophrenia', '36 patients', 'Thirty patients (16 and 14 in active and sham groups) completed the study', 'TRS subjects']","['intermittent theta burst stimulation (iTBS', 'Intensive Cerebellar Intermittent Theta Burst Stimulation (iCiTBS', 'placebo', 'Trans-cranial magnetic stimulation (TMS', 'Placebo', 'intensive cerebellar iTBS (iCiTBS']","['Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale (BPRS), Schizophrenia Cognition Rating Scale (SCoRS), Simpson-Angus Extrapyramidal Side Effects Scale (SAS), and Clinical Global Impression (CGI', 'safe and well tolerated', 'schizophrenia psychopathology, cognitive functions, and global improvement']","[{'cui': 'C3544321', 'cui_str': 'Treatment-resistant schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",36.0,0.25617,No major side effects were reported.,"[{'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Chauhan', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun, Uttrakhand, 248001, India.'}, {'ForeName': 'Shobit', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun, Uttrakhand, 248001, India. shobit.garg@gmail.com.'}, {'ForeName': 'Sai Krishna', 'Initials': 'SK', 'LastName': 'Tikka', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences (AIIMS), Raipur, India.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Khattri', 'Affiliation': 'Department of Psychiatry, Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun, Uttrakhand, 248001, India.'}]","Cerebellum (London, England)",['10.1007/s12311-020-01193-9']
2693,32964624,The effect of in-session exposure in Fear-Avoidance treatment of chronic low back pain: A randomized controlled trial.,"BACKGROUND


Treatment based on the Fear-Avoidance (FA) model has been found to be effective with chronic low back pain (CLBP), and in-vivo exposure of fear evoking movements is proposed as a key change mechanism. Exposure tasks may be conducted in the session (in-session exposure; ISE), in other real life situations (between sessions exposure) as part of homework assignments, or both. Utilizing a randomized, controlled dismantling study design, the aim of this study was to examine the unique effects of ISE in FA-treatment of CLBP.
METHODS


Patients (N = 90) with CLBP as primary medical complaint were randomized to receive six sessions of either a) FA-treatment with ISE (FA-ISE) or b) FA-treatment without ISE (FA), allowing for between sessions exposure in both treatment groups. Patients were assessed with a large battery of outcome measures at four time-points (pre-treatment, post-treatment, after a booster-session and at 1 year follow-up) including pain intensity, pain catastrophizing, self-efficacy, physical performance and quality of life.
RESULTS


Both treatment groups (FA-ISE, FA) demonstrated statistically significant improvements on primary and most secondary outcomes, with mostly non-significant between-group differences.
CONCLUSIONS


No added benefit was found for the inclusion of ISE of feared movements in FA-treatment for CLBP, delivered in a group format to participants with moderate elevated levels of fear-avoidance beliefs.
SIGNIFICANCE


This study adds to the existing research literature demonstrating FA-treatment to be effective with CLBP, but further experimental studies are needed in order to examine under what circumstances ISE of feared movements may add to positive treatment outcomes.",2020,"No added benefit was found for the inclusion of ISE of feared movements in FA-treatment for CLBP, delivered in a group format to participants with moderate elevated levels of fear-avoidance beliefs.
","['Patients (N = 90) with CLBP as primary medical complaint', 'chronic low back pain']","['FA-treatment with ISE (FA-ISE) or b) FA-treatment without ISE (FA', 'ISE']","['pain intensity, pain catastrophizing, self-efficacy, physical performance and quality of life', 'fear-avoidance beliefs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0201747', 'cui_str': 'Ion selective electrode measurement'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",90.0,0.051397,"No added benefit was found for the inclusion of ISE of feared movements in FA-treatment for CLBP, delivered in a group format to participants with moderate elevated levels of fear-avoidance beliefs.
","[{'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Ryum', 'Affiliation': 'Department of Psychology, Norwegian University of Science and Technology, Norway.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Hartmann', 'Affiliation': 'Department of Physical medicine and Rehabilitation, Levanger Hospital, Norway.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Borchgrevink', 'Affiliation': 'Department of Psychology, Norwegian University of Science and Technology, Norway.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'de Ridder', 'Affiliation': 'Department of Public Health and Surveillance, Scientific Institute of Public Health, Belgium.'}, {'ForeName': 'Tore C', 'Initials': 'TC', 'LastName': 'Stiles', 'Affiliation': 'Department of Psychology, Norwegian University of Science and Technology, Norway.'}]","European journal of pain (London, England)",['10.1002/ejp.1659']
2694,32964693,Clinical and cost-effectiveness of nurse-led cognitive behavioral group therapy for recovery of self-esteem among individuals with mental disorders: A single-group pre-post study.,"AIM


To investigate whether the addition of a nurse-led cognitive behavioral group therapy for recovery of self-esteem (CBGTRS) program to usual care for individuals with mental disorders can improve clinical outcomes and reduce direct medical costs.
METHODS


This study employed single-group pre-post design, and recruited 51 community-dwelling individuals with mental disorders. Participants received 12 weekly CBGTRS sessions by a nurse in addition to usual care. The primary outcome measure was the level of self-esteem, with other clinical outcomes and direct medical costs. The clinical outcomes were measured at pre-intervention (T0), intervention midpoint (T1), immediate post-intervention (T2), and 3 months post-intervention (T3). Direct medical costs were calculated for 3 months pre-intervention (A0), 3 months post-intervention (A1), between 4-6 months post-intervention (A2), and between 7-9 months post-intervention (A3).
RESULTS


Self-esteem scores were significantly improved from T0 to T2 and T3 (p = .009 and .006, respectively); within-group effect sizes were .49 (small) for T0-T2, and .51 (medium) for T0-T3. Other secondary clinical outcomes for mood, cognitive bias, global functioning, and quality of life were also improved by T3 (all p < .05). The mean total direct medical costs were significantly reduced from A0 (49,569.51 JPY) to A2 and A3 (21,845.76 JPY and 25,981.69 JPY, respectively) (p = .003 and .017, respectively).
CONCLUSIONS


The results suggest that nurse-led CBGTRS for mental disorders is a potentially effective approach in improving self-esteem and other clinical outcomes, and in reducing direct medical costs. Further controlled studies that address the limitations of this study are required.",2020,"Other secondary clinical outcomes for mood, cognitive bias, global functioning, and quality of life were also improved by T3 (all p < .05).","['individuals with mental disorders', '51 community-dwelling individuals with mental disorders']",['nurse-led cognitive behavioral group therapy'],"['level of self-esteem, with other clinical outcomes and direct medical costs', 'mean total direct medical costs', 'recovery of self-esteem', 'Self-esteem scores', 'pre-intervention (T0), intervention midpoint (T1), immediate post-intervention (T2), and 3\u2009months post-intervention (T3', 'Direct medical costs', 'mood, cognitive bias, global functioning, and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",51.0,0.0400006,"Other secondary clinical outcomes for mood, cognitive bias, global functioning, and quality of life were also improved by T3 (all p < .05).","[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Kunikata', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Kagawa Prefectural University of Health Sciences, Takamatsu, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yoshinaga', 'Affiliation': 'School of Nursing, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Center for Next Generation of Community Health, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Furushima', 'Affiliation': 'Department of Drug Evaluation and Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12371']
2695,32964717,Effect of Combining Furosemide With Standard Hydration Therapy on Contrast-Induced Acute Kidney Injury Following Coronary Angiography or Intervention in a High-Risk Population.,"This study aimed to investigate whether combining furosemide with standard hydration therapy results in increased preventive effects on contrast-induced acute kidney injury (CI-AKI) following coronary angiography (CA) or percutaneous coronary intervention (PCI). Patients (n = 230) were enrolled in the study and were randomized to the furosemide group or the control group. Patients in the furosemide group received 0.2 to 0.5 mg/kg of furosemide as a continuous intravenous infusion for 24 hours postoperatively and the same standard hydration regimen received by the control group. Blood samples were obtained 24 hours before and 48 hours after the procedure and urine volume was recorded postprocedure. Patients were followed up for an average of 6 months after the procedure. The incidence of CI-AKI in the furosemide group was significantly lower than that in the control group (8.7% vs 18.3%,  P  = .034). Multivariate logistic regression showed that age-glomerular filtration rate-ejection fraction score and V/estimated glomerular filtration rate ratio were independent risk factors for CI-AKI. During the average 6-month follow-up, incidence of major adverse cardiovascular events (MACEs) in the furosemide group was also significantly lower. Furosemide combined with standard hydration therapy may reduce the incidence of CI-AKI and MACEs following CA or PCI.",2020,Furosemide combined with standard hydration therapy may reduce the incidence of CI-AKI and MACEs following CA or PCI.,"['Patients (n = 230', 'Contrast-Induced Acute Kidney Injury Following Coronary Angiography or Intervention in a High-Risk Population']","['Furosemide combined with standard hydration therapy', 'furosemide', 'coronary angiography (CA) or percutaneous coronary intervention (PCI', 'Furosemide With Standard Hydration Therapy', 'furosemide with standard hydration therapy']","['incidence of CI-AKI and MACEs', 'Blood samples', 'age-glomerular filtration rate-ejection fraction score and V/estimated glomerular filtration rate ratio', 'incidence of CI-AKI', 'incidence of major adverse cardiovascular events (MACEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",230.0,0.0534097,Furosemide combined with standard hydration therapy may reduce the incidence of CI-AKI and MACEs following CA or PCI.,"[{'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'School of Medicine, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Gaoliang', 'Initials': 'G', 'LastName': 'Yan', 'Affiliation': 'Department of Cardiology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'School of Medicine, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Jinling Hospital Department Cardiology, Nanjing University, School of Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qigao', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Jinling Hospital Department Cardiology, Nanjing University, School of Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jianbin', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Jinling Hospital Department Cardiology, Nanjing University, School of Medicine, Nanjing, Jiangsu, China.'}, {'ForeName': 'Chengchun', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'School of Medicine, Southeast University, Nanjing, Jiangsu, China.'}]",Angiology,['10.1177/0003319720959968']
2696,32964771,Executive Function Training for Preschool Children With ADHD: A Randomized Controlled Trial.,"OBJECTIVE


This randomized controlled study explored the efficacy, feasibility, and acceptability of executive function training (EFT) for preschool children with ADHD.
METHOD


The current study design was an 8 week randomized parallel groups, single-blinded trial, using EFT-P. A total of 96 children with an ADHD diagnosis at age 4 to 5 years old were randomized into the intervention group and waitlist group. In the intervention group, 46 out of 50 participants completed the 8-week program, compared with 39 out of 46 in the waiting group. The level of ADHD symptoms and the executive function (EF) were evaluated by both neuropsychological tests from NEPSY Second Edition (NEPSY-II) and Behavior Rating Inventory of Executive Function Preschool version (BRIEF-P).
RESULTS


The EFT is feasible to administer and is acceptable for preschool children, with a 93% retention rate. Results showed that following the intervention, the visual-motor precision ( p  = .024), ADHD diagnostic state ( p  = .01), and oppositional defiant symptoms ( p  = .023) improved significantly in preschool children. However, the symptoms of ADHD and other EF evaluations were found to be insignificant.
CONCLUSION


The EFT is feasible, acceptable, and potentially effective to reduce symptoms and improve EF for preschool children with ADHD. The next step is to extend the program time and provide more frequent practice of activities between the children and the therapist and/or parent, to improve the effectiveness.",2020,"Results showed that following the intervention, the visual-motor precision ( p  = .024), ADHD diagnostic state ( p  = .01), and oppositional defiant symptoms ( p  = .023) improved significantly in preschool children.","['Preschool Children', 'preschool children with ADHD', 'preschool children', '96 children with an ADHD diagnosis at age 4 to 5\u2009years old']","['executive function training (EFT', 'Executive Function Training', 'ADHD', 'EFT', 'intervention group and waitlist group']","['level of ADHD symptoms and the executive function (EF', 'oppositional defiant symptoms', 'ADHD diagnostic state', 'visual-motor precision', 'neuropsychological tests from NEPSY Second Edition (NEPSY-II) and Behavior Rating Inventory of Executive Function Preschool version (BRIEF-P']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0589092', 'cui_str': 'Executive functions training'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",96.0,0.0432911,"Results showed that following the intervention, the visual-motor precision ( p  = .024), ADHD diagnostic state ( p  = .01), and oppositional defiant symptoms ( p  = .023) improved significantly in preschool children.","[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Shuai', 'Affiliation': 'Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'De Montfort University, Leicester, UK.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, China.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'De Montfort University, Leicester, UK.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, China.'}, {'ForeName': 'Runsen', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Central South University, Chinese National Clinical Research Centre on Mental Disorders (Xiangya), Chinese National Technology Institute on Mental Disorders, Hunan Key Laboratory of Psychiatry and Mental Health, China.'}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, China.'}]",Journal of attention disorders,['10.1177/1087054720956723']
2697,32967404,Intradiscal Pulsed Radiofrequency Application Duration Effect on Lumbar Discogenic Low Back Pain.,"BACKGROUND


Discogenic pain is recognized as the most important and most common cause of low back pain (LBP). Intradiscal pulsed radiofrequency (ID-PRF) is used for the treatment of chronic discogenic pain.
OBJECTIVES


We investigated the effects of the duration of percutaneous monopolar ID-PRF application on chronic discogenic LBP.
STUDY DESIGN


Retrospective study.
SETTING


Department of Anesthesiology and Pain Medicine, Neurosurgery at Wooridul Spine Hospital.
METHODS


Forty-five patients were included in this retrospective study. The patients were assigned into 2 groups according to the duration of the PRF procedure they underwent (7-minute group = 17 patients vs. 15-minute group = 28 patients). The main outcome measures tested were pain score, as determined by the Numeric Rating Scale (NRS-11) and the Oswestry Disability Index (ODI), at baseline, at 2-week, and 6-month follow-up visits. Success was defined as a reduction in NRS-11 of 50% or more or an ODI reduction of 40% or more.
RESULTS


The mean posttreatment pain scores at 2 weeks and 6 months were significantly lower (P < 0.05) in both groups, but the differences between the groups were not significant. ODI scores were also significantly lower compared with the baseline, but the differences between the groups were not significant. At the 6-month follow-up, 12 patients (70.6%) in the 7-minute group and 20 patients (71.4%) in the 15-minute group reported more than 50% reduction in the pain score (P = 0.16), and there was no significant difference between the 2 groups in the number of patients with more than 40% reduction in ODI score (P = 0.23).
LIMITATIONS


This study was performed with a small sample size and there was no control group. Additional well-designed and well-controlled studies that include parameters such as the stimulation duration, mode, and intensity of PRF are needed to fully assess the efficiency of ID-PRF.
CONCLUSIONS


ID-PRF was shown to be effective for the treatment of discogenic LBP regardless of duration of ID-PRF application (7 vs. 15 minutes).",2020,"The mean posttreatment pain scores at 2 weeks and 6 months were significantly lower (P < 0.05) in both groups, but the differences between the groups were not significant.","['Forty-five patients', 'Department of Anesthesiology and Pain Medicine, Neurosurgery at Wooridul Spine Hospital', 'chronic discogenic pain']","['Intradiscal pulsed radiofrequency (ID-PRF', 'Intradiscal Pulsed Radiofrequency Application Duration Effect', 'percutaneous monopolar ID-PRF application']","['mean posttreatment pain scores', 'Lumbar Discogenic Low Back Pain', 'ODI scores', 'ODI reduction', 'pain score, as determined by the Numeric Rating Scale (NRS-11) and the Oswestry Disability Index (ODI', 'ODI score', 'pain score']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3662528', 'cui_str': 'Discogenic pain'}]","[{'cui': 'C1512934', 'cui_str': 'Intradiscal route'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1291733', 'cui_str': 'Posttreatment pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",45.0,0.0303313,"The mean posttreatment pain scores at 2 weeks and 6 months were significantly lower (P < 0.05) in both groups, but the differences between the groups were not significant.","[{'ForeName': 'Chan Hong', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Daegu Wooridul Spine Hospital, Jung-Gu, Daegu, Republic of Korea.'}, {'ForeName': 'Sang Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Wooridul Spine Hospital, Korea.'}, {'ForeName': 'Pyng Bok', 'Initials': 'PB', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Bundang Hospital, Korea.'}]",Pain physician,[]
2698,32967406,High-Voltage Intraarticular Pulsed Radiofrequency for Chronic Knee Pain Treatment: A Single-Center Retrospective Study.,"BACKGROUND


Intraarticular pulsed radiofrequency (IAPRF) for the treatment of painful knee osteoarthritis (KOA) is a less invasive treatment method. It has fewer adverse effects and can quickly reduce KOA-related pain and improve knee joint dysfunction.
OBJECTIVES


We compared the effectiveness of high- and low-voltage IAPRF for the treatment of chronic knee pain.
STUDY DESIGN


Retrospective comparative study design.
SETTING


This study took place at Shengjing Hospital of China Medical University.
METHODS


A total of 57 patients with KOA who were hospitalized between July 2018 and July 2019 were randomly allocated into the high-voltage (n = 29) and low-voltage (n = 28) IAPRF groups. IAPRF was performed under the guidance of computed tomography (CT). Numeric Rating Scale (NRS-11), Oxford Knee Score (OKS), degree of pain relief, global perceived effect, and side effects at baseline and 1 week, 2 weeks, 1 month, 3 months, and 6 months after the procedure were recorded and analyzed.
RESULTS


NRS-11 scores decreased significantly in both groups after the procedure, but gradually increased after the 6-month follow-up period. There was a significant difference in NRS-11 scores between the 2 groups at all follow-up periods postprocedure. OKS were similar between the 2 groups. Patients with pain relief rate 50% or greater at 1, 3, and 6 months after the procedure accounted for 72.41%, 72.41%, and 55.17% in the high-voltage group, and 46.43%, 46.43%, and 28.57% in the low-voltage group, respectively. The difference between the 2 groups was statistically significant. No significant adverse reactions were observed in the 2 groups, however, patient satisfaction in the high-voltage group was significantly higher compared with patients in the low-voltage group.
LIMITATIONS


This study was a single-center retrospective study with a relatively small sample cohort and short follow-up period.
CONCLUSIONS


CT-guided high-voltage IAPRF is more beneficial in reducing knee pain and improving knee function compared with low-voltage IAPRF. In addition, patients who received high-voltage IAPRF were more satisfied with their treatment.",2020,There was a significant difference in NRS-11 scores between the 2 groups at all follow-up periods postprocedure.,"['Chronic Knee Pain Treatment', '57 patients with KOA who were hospitalized between July 2018 and July 2019', 'chronic knee pain', 'place at Shengjing Hospital of China Medical University', 'painful knee osteoarthritis (KOA']","['Intraarticular pulsed radiofrequency (IAPRF', 'CT-guided high-voltage IAPRF', 'high- and low-voltage IAPRF', 'High-Voltage Intraarticular Pulsed Radiofrequency', 'IAPRF']","['NRS-11 scores', 'Numeric Rating Scale (NRS-11), Oxford Knee Score (OKS), degree of pain relief, global perceived effect, and side effects', 'patient satisfaction', 'adverse reactions', 'knee pain and improving knee function', 'OKS', 'pain relief rate']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",57.0,0.033429,There was a significant difference in NRS-11 scores between the 2 groups at all follow-up periods postprocedure.,"[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Shimeng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Guangxiao', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Zhenkai', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Shengjing Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Department of Pain Management, Shengjing Hospital of China Medical University, Shenyang, China.'}]",Pain physician,[]
2699,32967413,"Subcapsular local anesthesia approach in percutaneous liver biopsy: Less pain, more Comfort.","BACKGROUND/AIM


To compare the subjective level of pain in patients who underwent an ultrasound-guided percutaneous liver biopsy (PLB) after either pericapsular anesthesia (PA) or subcapsular anesthesia (SA), based on the Numeric Rating Scale (NRS).
MATERIALS AND METHODS


A total of 323 patients, mean age 51, range 21-82 years; 160 (49.5%) male, referred to the Interventional Radiology Clinic of Kocaeli University Faculty of Medicine for image-guided PLB, between June 2019 and May 2020 were included and randomized into two groups by anesthetic type; the first (n=171) consisted of patients undergoing SA while the second (n=152) included patients undergoing PA. The intensity of pain at 0, 1, and 6 hours after PLB was evaluated between the groups using NRS.
RESULTS


At hours 0, 1, and 6, the median [range] NRS scores in the subcapsular and pericapsular groups were 2 [1-2] versus 3 [2-4] (p<0.001), 1 [0-1] versus 1 [1-2] (p<0.001), and 0 [0-0] versus 1 [0-1] (p<0.001), respectively. Subgroup analysis revealed that the patients who underwent the subcostal procedure with subcapsular anesthesia reported the lowest pain scores and intercostal procedure with pericapsular anesthesia reported the worst pain scores for each time point: 0 hours 1 [1-2] versus 3 [3-4], p<0.001; one hour 1 [0-1] versus 1 [1-2], p<0.001; and six hours 0 [0-0] versus 0 [0-1], p<0.001, respectively.
CONCLUSION


Subcapsular anesthesia is a well-tolerated procedure compared to a pericapsular procedure. Furthermore, the application of a subcapsular anesthetic with a subcostal approach was reported to result in the lowest pain and greatest patient comfort.",2020,"Subgroup analysis revealed that the patients who underwent the subcostal procedure with subcapsular anesthesia reported the lowest pain scores and intercostal procedure with pericapsular anesthesia reported the worst pain scores for each time point: 0 hours 1 [1-2] versus 3 [3-4], p<0.001; one hour 1","['percutaneous liver biopsy', 'male, referred to the Interventional Radiology Clinic of Kocaeli University Faculty of Medicine for image-guided PLB, between June 2019 and May 2020 were included and randomized into two groups by anesthetic type; the first (n=171) consisted of patients undergoing SA while the second (n=152) included patients undergoing PA', 'patients who underwent an', 'A total of 323 patients, mean age 51, range 21-82 years; 160 (49.5']","['ultrasound-guided percutaneous liver biopsy (PLB) after either pericapsular anesthesia (PA) or subcapsular anesthesia (SA', 'Subcapsular anesthesia', 'subcapsular anesthesia']","['worst pain scores', 'Numeric Rating Scale (NRS', 'lowest pain scores', 'intensity of pain', 'median [range] NRS scores', 'subjective level of pain']","[{'cui': 'C0558534', 'cui_str': 'Percutaneous liver biopsy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0034602', 'cui_str': 'Interventional radiology - specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1305863', 'cui_str': 'Anesthesia type'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205152', 'cui_str': 'Subcapsular'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0558534', 'cui_str': 'Percutaneous liver biopsy'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205152', 'cui_str': 'Subcapsular'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",323.0,0.0604371,"Subgroup analysis revealed that the patients who underwent the subcostal procedure with subcapsular anesthesia reported the lowest pain scores and intercostal procedure with pericapsular anesthesia reported the worst pain scores for each time point: 0 hours 1 [1-2] versus 3 [3-4], p<0.001; one hour 1","[{'ForeName': 'ÖzgÜr', 'Initials': 'Ö', 'LastName': 'Çakir', 'Affiliation': ''}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Aksu', 'Affiliation': ''}]",Turkish journal of medical sciences,['10.3906/sag-2006-346']
2700,32967430,Dupilumab as Add-on Therapy for Chronic Rhinosinusitis With Nasal Polyposis in Aspirin Exacerbated Respiratory Disease.,"BACKGROUND


Aspirin-exacerbated respiratory disease (AERD) affects 7% of asthmatics. Usual therapies are inadequate for asthma and/or nasal polyposis, leading to decreased quality of life.
OBJECTIVE


Our objective was to evaluate the efficacy of dupilumab in AERD patients with uncontrolled, chronic rhinosinusitis with nasal polyposis (CRSwNP).
METHODS


Patients 18 years and older with a physician diagnosis of AERD and sino-nasal outcome test 22 (SNOT 22) score ≥19 despite standard medical therapy were eligible for the study. Patients received one month of placebo dosing, followed by 6 months of dupilumab. Patients were blinded to the order of therapy. Wilcoxon-paired rank sum test was used to compare study outcomes at baseline and the completion of the study.
RESULTS


Ten patients completed the study. The median baseline SNOT 22 score improved from 46 [IQR: 34 to 64.8] to 9.5 [IQR: 2.5 to 19] after 6 months of therapy (p = 0.0050). The median baseline Lund MacKay score improved from 21.5 [IQR: 17 to 23.3] to 4 [IQR: 1.2 to 6] after 6 months of therapy (p = 0.0050). There was also improvement in the following secondary outcomes: asthma control test (ACT), mini asthma quality of life questionnaire (AQLQ), and University of Pennsylvania Smell Identification test (UPSIT). Exhaled nitric oxide (FeNO), total serum IgE, 24-hour urinary leukotriene E 4 , and serum thymus and activation regulated cytokine (TARC) also decreased. There were no significant study-related adverse events.
CONCLUSION


Dupilumab was highly effective as add-on therapy for CRSwNP in AERD, improving patient-reported outcomes, sinus opacification, and markers of T2 inflammation.",2020,"There was also improvement in the following secondary outcomes: asthma control test (ACT), mini asthma quality of life questionnaire (AQLQ), and University of Pennsylvania Smell Identification test (UPSIT).","['AERD patients with uncontrolled, chronic rhinosinusitis with nasal polyposis (CRSwNP', 'Patients 18\u2009years and older with a physician diagnosis of AERD and sino-nasal outcome test 22', 'Chronic Rhinosinusitis With Nasal Polyposis in Aspirin Exacerbated Respiratory Disease']","['placebo', 'dupilumab']","['Exhaled nitric oxide (FeNO), total serum IgE, 24-hour urinary leukotriene E 4 , and serum thymus and activation regulated cytokine (TARC', 'median baseline SNOT 22 score', 'median baseline Lund MacKay score', 'secondary outcomes: asthma control test (ACT), mini asthma quality of life questionnaire (AQLQ), and University of Pennsylvania Smell Identification test (UPSIT']","[{'cui': 'C3853540', 'cui_str': 'Aspirin exacerbated respiratory disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}, {'cui': 'C0040112', 'cui_str': 'Thymus Extracts'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C2919855', 'cui_str': 'Mini asthma quality of life questionnaire'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0551184,"There was also improvement in the following secondary outcomes: asthma control test (ACT), mini asthma quality of life questionnaire (AQLQ), and University of Pennsylvania Smell Identification test (UPSIT).","[{'ForeName': 'S Shahzad', 'Initials': 'SS', 'LastName': 'Mustafa', 'Affiliation': 'Division of Allergy, Immunology, Rheumatology, Rochester Regional Health, Rochester, New York.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Vadamalai', 'Affiliation': 'Division of Critical Care, Mercy Hospital, Springfield, Missouri.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Scott', 'Affiliation': 'Division of Allergy, Immunology, Rheumatology, Rochester Regional Health, Rochester, New York.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ramsey', 'Affiliation': 'Division of Allergy, Immunology, Rheumatology, Rochester Regional Health, Rochester, New York.'}]",American journal of rhinology & allergy,['10.1177/1945892420961969']
2701,32967495,Effect of intersphincteric fistula tract ligation versus anal fistulectomy on pain scores and serum levels of vascular endothelial growth factor and interleukin-2 in patients with simple anal fistulas.,"OBJECTIVE


This study was performed to explore the effects of ligation of the intersphincteric fistula tract (LIFT) on pain scores and serum levels of vascular endothelial growth factor (VEGF) and interleukin (IL)-2 in patients with simple anal fistulas.
METHODS


Ninety patients with simple anal fistulas were evenly randomized into a study group (treated with LIFT) and a control group (treated with traditional anal fistulectomy) according to a random number table. The surgical outcomes, basic operation conditions (operation time, hospital stay, and anal continence), and postoperative wound healing rates were compared between the two groups.
RESULTS


The study group had significantly better operation conditions (better anal continence and shorter length of hospital stay), a higher postoperative wound healing rate, lower pain scores, higher VEGF and IL-2 levels, and higher overall efficacy rate than the control group. However, the incidence of postoperative complications was not significantly different between the two groups.
CONCLUSIONS


Patients who underwent LIFT had better surgical outcomes, higher wound healing rates, better anal continence, a shorter length of hospital stay, and less severe postoperative pain than those who underwent simple anal fistulectomy. Increased levels of VEGF and IL-2 after surgery may promote wound healing.",2020,"The study group had significantly better operation conditions (better anal continence and shorter length of hospital stay), a higher postoperative wound healing rate, lower pain scores, higher VEGF and IL-2 levels, and higher overall efficacy rate than the control group.","['Ninety patients with simple anal fistulas', 'patients with simple anal fistulas']","['intersphincteric fistula tract (LIFT', 'intersphincteric fistula tract ligation versus anal fistulectomy', 'LIFT', 'control group (treated with traditional anal fistulectomy']","['severe postoperative pain', 'pain scores and serum levels of vascular endothelial growth factor and interleukin-2', 'pain scores and serum levels of vascular endothelial growth factor (VEGF) and interleukin (IL)-2', 'incidence of postoperative complications', 'surgical outcomes, basic operation conditions (operation time, hospital stay, and anal continence), and postoperative wound healing rates', 'operation conditions (better anal continence and shorter length of hospital stay', 'surgical outcomes, higher wound healing rates, better anal continence, a shorter length of hospital stay', 'postoperative wound healing rate, lower pain scores, higher VEGF and IL-2 levels, and higher overall efficacy rate']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0149889', 'cui_str': 'Anorectal fistula'}]","[{'cui': 'C0341379', 'cui_str': 'Intersphincteric fistula'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0193125', 'cui_str': 'Anal fistulectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1290944', 'cui_str': 'Anorectal continence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",90.0,0.0391366,"The study group had significantly better operation conditions (better anal continence and shorter length of hospital stay), a higher postoperative wound healing rate, lower pain scores, higher VEGF and IL-2 levels, and higher overall efficacy rate than the control group.","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Zhanbo', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Bianfang', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Xuebin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Fagang', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}, {'ForeName': 'Longtao', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': ""Anorectal Department, Dongying People's Hospital, Dongying, Shandong, China.""}]",The Journal of international medical research,['10.1177/0300060520949072']
2702,32967500,GPX3  methylation is associated with hematologic improvement in low-risk myelodysplastic syndrome patients treated with Pai-Neng-Da.,"OBJECTIVE


The aim of this prospective randomized controlled clinical trial was to explore the relationship between  GPX3  methylation and Pai-Neng-Da (PND) in the treatment of patients with low-risk myelodysplastic syndrome (MDS).
METHODS


There were 82 low-risk MDS patients who were randomly divided into the following two groups: androl, thalidomide, and PND capsule (ATP group, n = 41); or androl and thalidomide (AT group, n = 41). Hemoglobin and neutrophil and platelet counts and changes in  GPX3  methylation level were assessed.
RESULTS


The plasma hemoglobin level increased in both groups after treatment. However, the platelet count increased only in the ATP group. Patients in the ATP group had a better platelet response than the AT group, and  GPX3  methylation markedly decreased after treatment with ATP but not after treatment with AT. Moreover, male patients had a significantly lower  GPX3  methylation level than female patients, while platelet counts from male patients increased dramatically after the ATP regimens compared with female patients.  GPX3  methylation changes were negatively correlated with platelet changes in ATP group.
CONCLUSION


PND can improve hematological parameters and decrease the  GPX3  methylation level. Decreasing  GPX3  methylation is associated with the hematologic response that includes platelet in  GPX3  methylation. China Clinical Trial Bureau (ChiCTR;  http://www.chictr.org.cn/ ) registration number : ChiCTR-IOR-15006635.",2020,"Patients in the ATP group had a better platelet response than the AT group, and  GPX3  methylation markedly decreased after treatment with ATP but not after treatment with AT.","['patients with low-risk myelodysplastic syndrome (MDS', '82 low-risk MDS patients']","['Pai-Neng-Da (PND', 'androl, thalidomide, and PND capsule (ATP group, n\u2009=\u200941); or androl and thalidomide', 'PND']","['platelet counts', 'platelet response', 'GPX3  methylation', 'GPX3  methylation level', 'Hemoglobin and neutrophil and platelet counts and changes in  GPX3  methylation level', 'platelet count', 'hematological parameters', 'Decreasing  GPX3', 'plasma hemoglobin level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}]","[{'cui': 'C4310131', 'cui_str': 'pai-neng-da'}, {'cui': 'C1956415', 'cui_str': 'Paroxysmal nocturnal dyspnea'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0474563', 'cui_str': 'Measurement of total hemoglobin concentration in plasma specimen'}]",82.0,0.0423834,"Patients in the ATP group had a better platelet response than the AT group, and  GPX3  methylation markedly decreased after treatment with ATP but not after treatment with AT.","[{'ForeName': 'Shujun', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Gao', 'Affiliation': 'Medical Genetics Center, School of Medicine, Ningbo University, Ningbo, Zhejiang, China.'}, {'ForeName': 'Zhonghua', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Medical Genetics Center, School of Medicine, Ningbo University, Ningbo, Zhejiang, China.'}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Lai', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Sheng', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Zhijuan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Jiaping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Shiwei', 'Initials': 'S', 'LastName': 'Duan', 'Affiliation': 'Medical Genetics Center, School of Medicine, Ningbo University, Ningbo, Zhejiang, China.'}, {'ForeName': 'Guifang', 'Initials': 'G', 'LastName': 'Ouyang', 'Affiliation': 'Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.'}]",The Journal of international medical research,['10.1177/0300060520956894']
2703,32967513,Psychological state of patients with sudden deafness and the effect of psychological intervention on recovery.,"OBJECTIVE


To determine the effect of personalized psychological interventions on the recovery of patients with sudden deafness.
METHODS


Participants were 438 patients with sudden deafness who were randomly allocated to observation and control groups. Patients in the control group received routine nursing care and drug treatment. Patients in the observation group received personalized psychological interventions, routine nursing care and drug treatment. The Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS) were used to measure anxiety and depression. The Simple Coping Style Questionnaire (SCSQ) and the Satisfaction With Life Scale (SWLS) were used to evaluate coping styles, attitude toward life and quality of life.
RESULTS


Patients in both groups had similar SAS and SDS scores at the time of admission. After treatment, there was a significant difference in SAS and SDS scores between the observation and control groups, indicating that the observation group had less anxiety and depression. Both groups had increased SCSQ and SWLS scores following treatment, indicating improvements in positive coping and satisfaction with life.
CONCLUSION


Effective psychological interventions may change negative thoughts, increase response rate and improve quality of life.",2020,"Both groups had increased SCSQ and SWLS scores following treatment, indicating improvements in positive coping and satisfaction with life.
","['Participants were 438 patients with sudden deafness who were randomly allocated to observation and control groups', 'patients with sudden deafness']","['personalized psychological interventions, routine nursing care and drug treatment', 'psychological intervention', 'personalized psychological interventions', 'routine nursing care and drug treatment']","['SAS and SDS scores', 'SCSQ and SWLS scores', 'Simple Coping Style Questionnaire (SCSQ) and the Satisfaction With Life Scale (SWLS', 'Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS', 'positive coping and satisfaction with life', 'response rate and improve quality of life', 'coping styles, attitude toward life and quality of life', 'anxiety and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1148477', 'cui_str': 'Sudden Deafness'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",438.0,0.022125,"Both groups had increased SCSQ and SWLS scores following treatment, indicating improvements in positive coping and satisfaction with life.
","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, The Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Liangliang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Otorhinolaryngology, The School Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Xiaoyong', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, The Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}, {'ForeName': 'Zhenghui', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, The Second Affiliated Hospital, Xi'an Jiaotong University, Xi'an, People's Republic of China.""}]",The Journal of international medical research,['10.1177/0300060520957536']
2704,32967528,The impact of mindfulness training on performance in a group decision-making task: Evidence from an experimental study.,"It is widely assumed that mindfulness training will lead to a range of benefits, from improved attentional capacities to better decision-making. Indeed, many large corporations have begun to provide workplace mindfulness training with the aim of improving group-based decision-making. Yet, there has been little empirical work testing the effects of mindfulness training on complex group-based task performance. In a randomised experimental study ( N  = 332), we examine the effects of two different durations of mindfulness training on strategic decision-making using the classic NASA survival task, assessing individual and then group performance. We expected that a longer training duration (seven daily sessions) would be associated with better group performance relative to a ""one-off"" training session. We did not find such an association: groups in the longer training condition made slightly, but not significantly, more errors than groups in the one-off condition. We did not find any differences across training conditions when examining individual performance. Our findings should be interpreted in light of numerous studies demonstrating the benefits of even short durations of mindfulness practice on cognitive performance. We conclude that our lengthier mindfulness training duration did not confer measurable benefits over a one-off training session at either the individual or the group level on a strategic decision-making task.",2020,"We did not find such an association: groups in the longer training condition made slightly, but not significantly, more errors than groups in the one-off condition.",[],['mindfulness training'],[],[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.014008,"We did not find such an association: groups in the longer training condition made slightly, but not significantly, more errors than groups in the one-off condition.","[{'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Parsons', 'Affiliation': 'Interacting Minds Centre, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Thomas Hessellund', 'Initials': 'TH', 'LastName': 'Nielsen', 'Affiliation': 'Department of Management, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Arnault-Quentin', 'Initials': 'AQ', 'LastName': 'Vermillet', 'Affiliation': 'Interacting Minds Centre, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Lykke Hansen', 'Affiliation': 'Interacting Minds Centre, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Mitkidis', 'Affiliation': 'Interacting Minds Centre, Aarhus University, Aarhus, Denmark.'}]",Quarterly journal of experimental psychology (2006),['10.1177/1747021820958190']
2705,32964512,The efficacy of two different oral hygiene regimens on the incidence and severity of oral mucositis in pediatric patients receiving hematopoietic stem cell transplantation: A prospective interventional study.,"AIMS


This prospective interventional study aimed to assess the efficacy of supersaturated calcium phosphate rinse and the use of an extra-soft toothbrush twice a day when added to the existing oral hygiene protocol regimen (0.12% chlorhexidine gluconate + 3% sodium bicarbonate + nystatin 5000 U/mL) in reducing the severity of oral mucositis among pediatric patients receiving chemotherapy for the hematopoietic stem cell transplant.
METHODS


Forty-five patients that received chemotherapy for the hematopoietic stem cell transplant were randomly allocated to three groups of 15 patients each. Group A was advised to follow the existing oral hygiene protocol regimen (Control), group B was advised to brush their teeth twice daily using an extra-soft toothbrush and to follow the control regimen, and lastly group C was advised to use supersaturated calcium phosphate rinse and to follow the control regimen. Oral mucositis was recorded according to World Health Organization criteria from the day of admission (day 1) to the day of discharge (day 28). The incidence of oral mucositis between the three groups was compared using the Kruskall-Wallis test while the severity of oral mucositis between the three groups was compared using a one-way ANOVA test.
RESULTS


The results of the study showed no significant difference in the incidence of oral mucositis between the three groups; however, there was a lower severity of oral mucositis in the supersaturated calcium phosphate rinse group when compared to the control group or the group who used an extra-soft toothbrush with the control regimen.
CONCLUSION


Although marginally fewer cases and lower severity of oral mucositis was observed in the group using supersaturated calcium phosphate rinse, the lack of statistical significance suggests that the evidence for their use is not conclusive. The results of this study also showed that the introduction of an extra-soft toothbrush into the oral hygiene regimen did not significantly reduce the incidence of oral mucositis and may actually be responsible for an increase in the severity of oral mucositis.",2020,"Although marginally fewer cases and lower severity of oral mucositis was observed in the group using supersaturated calcium phosphate rinse, the lack of statistical significance suggests that the evidence for their use is not conclusive.","['Forty-five patients that received chemotherapy for the hematopoietic stem cell transplant', 'pediatric patients receiving chemotherapy for the hematopoietic stem cell transplant', 'pediatric patients receiving hematopoietic stem cell transplantation']","['supersaturated calcium phosphate rinse', 'chlorhexidine gluconate + 3% sodium bicarbonate + nystatin 5000 U/mL', 'oral hygiene regimens']","['Oral mucositis', 'incidence of oral mucositis', 'incidence and severity of oral mucositis', 'oral mucositis', 'severity of oral mucositis']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0028741', 'cui_str': 'Nystatin'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.00970127,"Although marginally fewer cases and lower severity of oral mucositis was observed in the group using supersaturated calcium phosphate rinse, the lack of statistical significance suggests that the evidence for their use is not conclusive.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mubaraki', 'Affiliation': 'Department of Preventive Dentistry, Riyadh Colleges of Dentistry and Pharmacy, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sharat Chandra', 'Initials': 'SC', 'LastName': 'Pani', 'Affiliation': 'Department of Preventive Dentistry, Riyadh Colleges of Dentistry and Pharmacy, Riyadh, Saudi Arabia.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Alseraihy', 'Affiliation': 'Department of Pediatric Hematology∖Oncology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Abed', 'Affiliation': ""Department of Sedation and Special Care Dentistry, Guy's & St Thomas' Foundation Trust, London, UK.""}, {'ForeName': 'Zikra', 'Initials': 'Z', 'LastName': 'Alkhayal', 'Affiliation': 'Department of Dentistry, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.'}]","Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry",['10.1111/scd.12525']
2706,32964565,Chronic immunoglobulin maintenance therapy in myasthenia gravis.,"BACKGROUND


Long-term treatment of myasthenia gravis (MG) includes symptomatic and course-modifying therapies that target the immune system. Recently, both IVIG and subcutaneous immunoglobulin (SCIG) have emerged as viable options for chronic therapy, considering the favourable safety-efficacy profile and possible immunosuppressant sparing properties. We aimed to investigate the outcomes of the long term care of generalized MG with immunoglobulins (Ig).
METHODS


This is a retrospective, repeated-measures design study. We analyzed charts of generalized MG (gMG) patients, treated with IVIG/SCIG for at least 6 months, from January 2015 to January 2020. The primary outcome was the mean change in Myasthenia Gravis Impairment Index (MGII) after treatment with Ig, comparing baseline to IVIG and SCIG treatment periods. Secondary outcomes included the changes in pyridostigmine, immunosuppressive medications and patient-reported outcome ""percentage of normal"" (%N) (0-100%).
RESULTS


Thirty-four patients were treated with chronic Ig therapy (30 IVIG/SCIG, 3 SCIG, 1 IVIG). Mean duration of IVIG and SCIG periods were 21.8±19.4 (range 3-64) and 19.5±11.3 (range 5-45) months respectively. There was a significant reduction in MGII scores (27.7±15.7 baseline; 22.0±17.4 IVIG period;19.5±18.1 SCIG period;F=17.9; df =1.7;p<0.01), pyridostigmine and immunosuppressant use (p=0.00). %N had a significant positive association with both treatments (p=0.00).
CONCLUSION


Our study results suggest that patients can be successfully transitioned to IVIG and from IVIG to SCIG in the chronic treatment of gMG with reductions in impairments and use of other medications and improvement in overall status with Ig therapy. Prospective, randomized studies are needed to clarify costs and comparative effectiveness.",2020,"There was a significant reduction in MGII scores (27.7±15.7 baseline; 22.0±17.4 IVIG period;19.5±18.1 SCIG period;F=17.9; df =1.7;p<0.01), pyridostigmine and immunosuppressant use (p=0.00).","['Thirty-four patients were treated with chronic Ig therapy (30 IVIG/SCIG, 3 SCIG, 1 IVIG', 'for at least 6 months, from January 2015 to January 2020', 'myasthenia gravis']","['Chronic immunoglobulin maintenance therapy', 'generalized MG with immunoglobulins (Ig', 'pyridostigmine', 'IVIG and subcutaneous immunoglobulin (SCIG', 'IVIG/SCIG']","['changes in pyridostigmine, immunosuppressive medications and patient-reported outcome ""percentage of normal', 'Mean duration of IVIG and SCIG periods', 'MGII scores', 'mean change in Myasthenia Gravis Impairment Index (MGII']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021022', 'cui_str': 'Immunoglobulin therapy'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0472367', 'cui_str': 'Generalized myasthenia'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",34.0,0.0723462,"There was a significant reduction in MGII scores (27.7±15.7 baseline; 22.0±17.4 IVIG period;19.5±18.1 SCIG period;F=17.9; df =1.7;p<0.01), pyridostigmine and immunosuppressant use (p=0.00).","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Alcantara', 'Affiliation': 'Ellen & Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Sarpong', 'Affiliation': 'Ellen & Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Barnett-Tapia', 'Affiliation': 'Ellen & Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Katzberg', 'Affiliation': 'Ellen & Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'Ellen & Martin Prosserman Centre for Neuromuscular Diseases, Toronto General Hospital, University Health Network, University of Toronto, Toronto, Canada.'}]",European journal of neurology,['10.1111/ene.14547']
2707,32964773,Teleaudiology hearing aid fitting follow-up consultations for adults: single blinded crossover randomised control trial and cohort studies.,"OBJECTIVE


To evaluate and compare the effectiveness and quality of standard face-to-face and teleaudiology hearing aid fitting follow-up consultations and blended services for adult hearing aid users.
DESIGN AND STUDY SAMPLE


Fifty-six participants were randomly allocated to two equal groups, with equal numbers of new and experienced users. One standard and one teleaudiology follow-up consultation were delivered by an audiologist, the latter assisted by a facilitator. The order was reversed for the second group. Outcome measurement tools were applied to assess aspects of participants' communication, fitting (physical, sensorial), quality of life, and service. Cross-sectional and longitudinal outcomes were analysed.
RESULTS


Most participants presented with moderate, sloping, and symmetrical sensorineural hearing loss. The duration of teleaudiology (42.96 ± 2.73 min) was equivalent to face-to-face consultations (41.25 ± 2.61 min). All modes of service delivery significantly improved outcomes for communication, fitting, and quality of life ( p  > 0.05). Satisfaction for both consultation modes was high, although significantly greater with standard consultations. The mode and order of delivery of the consultations did not influence the outcomes.
CONCLUSION


Teleaudiology hearing aid follow-up consultations can deliver significant improvements, and do not differ from standard consultations. Blended services also deliver significant improvements. Satisfaction can be negatively impacted by technical or human-related issues.",2020,"All modes of service delivery significantly improved outcomes for communication, fitting, and quality of life ( p  > 0.05).","['adult hearing aid users', 'adults', 'Fifty-six participants']","['standard face-to-face and teleaudiology hearing aid fitting follow-up consultations and blended services', 'Teleaudiology hearing aid fitting follow-up consultations']","['communication, fitting, and quality of life', 'duration of teleaudiology', ""participants' communication, fitting (physical, sensorial), quality of life, and service"", 'Satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0422322', 'cui_str': 'Follow-up consultation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",56.0,0.0477665,"All modes of service delivery significantly improved outcomes for communication, fitting, and quality of life ( p  > 0.05).","[{'ForeName': 'Karina F M', 'Initials': 'KFM', 'LastName': 'Tao', 'Affiliation': 'Ear Sciences Centre, Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Tais de C', 'Initials': 'TC', 'LastName': 'Moreira', 'Affiliation': 'Department of Social Responsibility, Hospital Moinhos de Vento, Porto Alegre, Brazil.'}, {'ForeName': 'Dona M P', 'Initials': 'DMP', 'LastName': 'Jayakody', 'Affiliation': 'Ear Sciences Centre, Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'De Wet', 'Initials': 'W', 'LastName': 'Swanepoel', 'Affiliation': 'Ear Sciences Centre, Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Brennan-Jones', 'Affiliation': 'Ear Health Team, Telethon Kids Institute, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'Coetzee', 'Affiliation': 'Ear Sciences Centre, Medical School, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Eikelboom', 'Affiliation': 'Ear Sciences Centre, Medical School, The University of Western Australia, Perth, Australia.'}]",International journal of audiology,['10.1080/14992027.2020.1805804']
2708,32964776,Greater Occipital Nerve Stimulation Boosts Associative Memory in Older Individuals: A Randomized Trial.,"Transcutaneous electrical stimulation (tES) is a new approach that aims to stimulate the brain. Recently, we have developed tES approaches to enhance plasticity that modulate cortical activity via the greater occipital nerve (ON) in a ""bottom-up"" way. Thirty subjects between the ages of 55 and 70 years were enrolled and tested using a double-blind, sham-controlled, and randomized design. Half of the participants received active stimulation, while the other half received sham stimulation. Our results demonstrate that ON-tES can enhance memory in older individuals after one session, with effects persisting up to 28 days after stimulation. The hypothesized mechanism by which ON-tES enhances memory is activation of the locus coeruleus-noradrenaline (LC-NA) pathway. It is likely that this pathway was activated after ON-tES, as supported by observed changes in α-amylase concentrations, a biomarker for noradrenaline. There were no significant or long-lasting side effects observed during stimulation. Clinicaltrial.gov (NCT03467698).",2020,There were no significant or long-lasting side effects observed during stimulation.,"['Thirty subjects between the ages of 55 and 70 years', 'Older Individuals']","['Transcutaneous electrical stimulation (tES', 'Greater Occipital Nerve Stimulation Boosts Associative Memory', 'ON-tES']",['long-lasting side effects'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0228814', 'cui_str': 'Greater occipital nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1283707', 'cui_str': 'Occipital nerve'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",30.0,0.221199,There were no significant or long-lasting side effects observed during stimulation.,"[{'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Luckey', 'Affiliation': 'Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'S Lauren', 'Initials': 'SL', 'LastName': 'McLeod', 'Affiliation': 'University of Texas at Dallas, Richardson, TX, USA.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Robertson', 'Affiliation': 'Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Wing Ting', 'Initials': 'WT', 'LastName': 'To', 'Affiliation': 'Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Vanneste', 'Affiliation': 'Trinity College Dublin, Dublin, Ireland.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320943573']
2709,32964788,Significant Improvement of Somatic Symptom Disorder With Brief Psychoeducational Intervention by PMHNP in Primary Care.,"BACKGROUND


Patients with somatic symptom disorders (SSD) are prevalent in primary care, urgent care, and emergency rooms and present with reduced quality of life, increased disability, and suicidality . Criteria for SSD include (1) somatic symptoms that cause distress and disrupt life; (2) concurrent physical illness with thoughts and feelings that are disproportionate to the seriousness of the illness; and (3) distress which is persistent and causes suffering. The frequency of SSD in the general population is 5% to 7%; however, in primary care, it is 5% to 35% . Because patients present with anxiety, depression, and/or pain, providers are flummoxed when diagnostic findings do not match symptom intensity.
AIMS


The purpose of this project was to provide an intervention for patients with SSD and measure its effectiveness on their somatic symptoms.
METHOD


This study provided a single-session, 30-minute psychoeducational intervention for patients to explain brain pathways for pain and the body's response to stress, including scientific benefits of exercise and healthy diet. Patients were asked questions using the motivational interviewing technique OARS (open-ended question, affirmation, reflection, summary) and were encouraged to talk about their concerns. The study used a pre- and post-intervention visual analogue scale and a self-reported Patient Health Questionnaire-15 both before and 3 weeks post-intervention.
RESULTS


Measurements showed significant symptom improvement immediately after the intervention with sustained improvement 3 weeks post-intervention.
CONCLUSIONS


This intervention demonstrates an effective treatment for this insidious illness, which plagues up to 35% of patients in primary care.",2020,"This study provided a single-session, 30-minute psychoeducational intervention for patients to explain brain pathways for pain and the body's response to stress, including scientific benefits of exercise and healthy diet.","['patients with SSD', 'Patients with somatic symptom disorders (SSD']","['pre- and post-intervention visual analogue scale and a self-reported Patient Health Questionnaire-15 both before and 3 weeks post-intervention', 'motivational interviewing technique OARS', 'PMHNP', 'psychoeducational intervention']",['frequency of SSD'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4087321', 'cui_str': 'Somatic symptom disorder'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4076391', 'cui_str': 'Motivational interviewing technique'}]","[{'cui': 'C0436350', 'cui_str': 'Symptom frequency'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0239442,"This study provided a single-session, 30-minute psychoeducational intervention for patients to explain brain pathways for pain and the body's response to stress, including scientific benefits of exercise and healthy diet.","[{'ForeName': 'Kim K', 'Initials': 'KK', 'LastName': 'Johnson', 'Affiliation': 'Kim K. Johnson, DNP, PMHNP-BC, NP-C, RN, School of Nursing, Middle Georgia State University, Macon, GA, USA.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Bennett', 'Affiliation': 'Carole Bennett, PhD, APRN, PMHCS-BC, Waters College of Health Professions, Georgia Southern University, Statesboro, GA, USA.'}, {'ForeName': 'Haresh', 'Initials': 'H', 'LastName': 'Rochani', 'Affiliation': 'Haresh Rochani, DrPH, MPH, MBBS, Biostatistics, K. E. Peace Center for Biostatistics, Georgia Southern University, Statesboro, GA, USA.'}]",Journal of the American Psychiatric Nurses Association,['10.1177/1078390320960524']
2710,32964809,Cross-trial prediction in psychotherapy: External validation of the Personalized Advantage Index using machine learning in two Dutch randomized trials comparing CBT versus IPT for depression.,"Abstract   Objective:  Optimizing treatment selection may improve treatment outcomes in depression. A promising approach is the Personalized Advantage Index (PAI), which predicts the optimal treatment for a given individual. To determine the generalizability of the PAI, models needs to be externally validated, which has rarely been done.  Method:  PAI models were developed within each of two independent trials, with substantial between-study differences, that both compared CBT and IPT for depression (STEPd:  n  = 151 and FreqMech:  n  = 200). Subsequently, both PAI models were tested in the other dataset.  Results:  In the STEPd study, post-treatment depression was significantly different between individuals assigned to their PAI-indicated treatment versus those assigned to their non-indicated treatment ( d  = .57). In the FreqMech study, post-treatment depression was not significantly different between patients receiving their indicated treatment versus those receiving their non-indicated treatment ( d  = .20). Cross-trial predictions indicated that post-treatment depression was not significantly different between those receiving their indicated treatment and those receiving their non-indicated treatment ( d  = .16 and  d  = .27). Sensitivity analyses indicated that cross-trial prediction based on only overlapping variables didn't improve the results.  Conclusion:  External validation of the PAI has modest results and emphasizes between-study differences and many other challenges.",2020,"In the STEPd study, post-treatment depression was significantly different between individuals assigned to their PAI-indicated treatment versus those assigned to their non-indicated treatment ( d  = .57).",[],"['CBT', 'PAI']",[],[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0032145', 'cui_str': 'Plasminogen activator inhibitor'}]",[],,0.0455391,"In the STEPd study, post-treatment depression was significantly different between individuals assigned to their PAI-indicated treatment versus those assigned to their non-indicated treatment ( d  = .57).","[{'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Van Bronswijk', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Sanne J E', 'Initials': 'SJE', 'LastName': 'Bruijniks', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Lorenzo-Luaces', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University, Bloomington, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Derubeis', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, USA.'}, {'ForeName': 'Lotte H J M', 'Initials': 'LHJM', 'LastName': 'Lemmens', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Frenk P M L', 'Initials': 'FPML', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical Psychology, Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1823029']
2711,32964818,Yoga's impact on risk and protective factors for disordered eating: a pilot prevention trial.,"Yoga has been proposed as a strategy for improving risk and protective factors for eating disorders, but few prevention trials have been conducted. The purpose of this pilot study was to assess the feasibility and acceptability of a yoga series in female college students (n = 52). Participants were randomized to a yoga intervention (three 50-minute yoga classes/week for 10 weeks conducted by certified yoga teachers who received a 3-day intensive training) or a control group. Risk and protective factors, assessed at baseline, 5 and 10 weeks, included body dissatisfaction, negative affect, loneliness, self-compassion, positive affect, and mindfulness. Mixed models controlling for baseline levels of outcome variables were run. On average, participants attended 20 out of 30 yoga classes, and the majority of participants reported high levels of satisfaction with the yoga series. Appearance orientation decreased and positive affect increased in the yoga group relative to the control group. After controlling for baseline levels, the yoga group had a significantly higher positive affect than the control group. Changes in other outcomes were not statistically significant, as compared to the control condition. Future yoga research directions are discussed including education about body image, measure and sample selection, and use of an implementation science framework.",2020,"After controlling for baseline levels, the yoga group had a significantly higher positive affect than the control group.","['female college students (n\xa0=\xa052', 'disordered eating']","['yoga intervention', 'certified yoga teachers who received a 3-day intensive training']","['body dissatisfaction, negative affect, loneliness, self-compassion, positive affect, and mindfulness', 'Appearance orientation', 'feasibility and acceptability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",52.0,0.046783,"After controlling for baseline levels, the yoga group had a significantly higher positive affect than the control group.","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Pacanowski', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware , Newark, Delaware, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Diers', 'Affiliation': 'Minneapolis, Minnesota, USA.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Sanford Center for Bio-Behavioral Research , Fargo, North Dakota, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mackenzie', 'Affiliation': 'Department of Behavioral Health and Nutrition, University of Delaware , Newark, Delaware, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Neumark-Sztainer', 'Affiliation': 'University of Minnesota , Minneapolis, Minnesota, USA.'}]",Eating disorders,['10.1080/10640266.2020.1763110']
2712,13289630,Actinomycin C trial in the treatment of malignant lymphadenopathy.,,1955,,['malignant lymphadenopathy'],['Actinomycin C'],[],"[{'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0497156', 'cui_str': 'Lymphadenopathy'}]","[{'cui': 'C0054404', 'cui_str': 'Cactinomycin'}]",[],,0.0192693,,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'CROIZAT', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'LACOSTE', 'Affiliation': ''}]",La Presse medicale,[]
2713,32969469,Impact of an Education Program on Ibd Patient's Skills: Results of A Randomized Controlled Multicenter Study (Ecipe).,"BACKGROUND


A better patient's knowledge on their Inflammatory Bowel Disease (IBD) could improve its outcome and quality of life. The aim of this study was to assess if an education program improves IBD patients' skills as regards to their disease.
METHODS


The GETAID group conducted a prospective multicenter randomized controlled study. IBD patients were included at diagnosis, or after a significant event in the disease course. Patients were randomized between ""educated"" or control groups for 6 months. Education was performed by trained healthcare professionals. A psycho-pedagogic score (ECIPE) was evaluated by a ""blinded"" physician at baseline and after 6 and 12 months (M6 and M12). The primary endpoint was the increase of ECIPE score at M6 of more than 20%.
RESULTS


263 patients were included in 19 centers (Male:40%; Median age:30.8; CD:73%). 133 patients were randomized in the educated group, and 130 in the control group. The median relative increase of the ECIPE score at M6 was higher in the educated group as compared to the control group (16.7%(0-42.1%) vs 7%(0-18.8%) respectively p=0.0008). The primary endpoint was met in 46% vs 24% of the patients in the educated and control groups respectively (p=0.0003). A total of 92 patients met the primary endpoint. In multivariate analysis, predictors of an increase of at least 20% of the ECIPE score were randomization in the educated group (OR=2.59) and no previous surgery (OR=1.92).
CONCLUSION


These findings support the set-up of education programs in centers involved in the management of IBD patients.",2020,The median relative increase of the ECIPE score at M6 was higher in the educated group as compared to the control group (16.7%(0-42.1%) vs 7%(0-18.8%) respectively p=0.0008).,"['263 patients', ""Ibd Patient's Skills"", '92 patients met the primary endpoint', '133 patients were randomized in the educated group, and 130 in the control group']","['Education Program', 'education program']","['A psycho-pedagogic score (ECIPE', 'ECIPE score at M6', 'ECIPE score']","[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",263.0,0.110174,The median relative increase of the ECIPE score at M6 was higher in the educated group as compared to the control group (16.7%(0-42.1%) vs 7%(0-18.8%) respectively p=0.0008).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Moreau', 'Affiliation': 'Gastroenterology Department, Hôpital Rangueil, Toulouse.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hammoudi', 'Affiliation': 'Gastroenterology Department, AP-HP, Hôpital Saint-Louis, INSERM UMRS 1160, Université Paris Diderot, Sorbonne Paris-Cité University, Paris, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Marthey', 'Affiliation': 'Gastroenterology Department, Hôpital du Kremlin-Bicetre, Kremlin Bicetre, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Trang-Poisson', 'Affiliation': 'Gastroenterology Department Hotel-Dieu, Nantes, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nachury', 'Affiliation': ""CHU Lille, Maladies de l'appareil digestif, Lille, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Altwegg', 'Affiliation': 'Gastroenterology Department, Hôpital St-Eloi, Montpellier, France.'}, {'ForeName': 'J-C', 'Initials': 'JC', 'LastName': 'Grimaud', 'Affiliation': 'Gastroenterology Department, Hôpital Nord, Marseille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Orempuller', 'Affiliation': 'Gastroenterology Department, Hôpital Rangueil, Toulouse.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Hébuterne', 'Affiliation': 'Gastroenterology Department, Hôpital Archet, Nice, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aubourg', 'Affiliation': 'Gastroenterology Department, Hôpital Trousseau, Tours, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Baudry', 'Affiliation': 'Gastroenterology Department, AP-HP, Hôpital Saint-Louis, INSERM UMRS 1160, Université Paris Diderot, Sorbonne Paris-Cité University, Paris, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Seksik', 'Affiliation': 'Department of Gastroenterology, INSERM, Centre de recherche Saint-Antoine, Sorbonne Université, AP-HP Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Roblin', 'Affiliation': 'Gastroenterology Department, Hôpital de St-Etienne, St-Etienne, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nahon', 'Affiliation': 'Gastroenterology Department, Hôpital de Montfermeil, Montfermeil, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Savoye', 'Affiliation': 'Gastroenterology Department, Hôpital Charles Nicolle, Rouen, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Mesnard', 'Affiliation': 'Gastroenterology Department, Hôpital Dron, Tourcoing, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stefanescu', 'Affiliation': 'Gastroenterology Department, Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': 'Gastroenterology Department, Institut Mutualiste Monsouris, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Coffin', 'Affiliation': 'Gastroenterology Department, Hôpital Louis Mourier, Colombes, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fumery', 'Affiliation': 'Gastroenterology Department, Hôpital Nord, Amiens, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Carbonnel', 'Affiliation': 'Gastroenterology Department, Hôpital du Kremlin-Bicetre, Kremlin Bicetre, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Desseaux', 'Affiliation': 'SBIM, Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Allez', 'Affiliation': 'Gastroenterology Department, AP-HP, Hôpital Saint-Louis, INSERM UMRS 1160, Université Paris Diderot, Sorbonne Paris-Cité University, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjaa195']
2714,32969489,"Dupilumab provides favourable long-term safety and efficacy in children aged ≥ 6 to < 12 years with uncontrolled, severe atopic dermatitis: results from an open-label phase IIa study and subsequent phase III open-label extension study.","BACKGROUND


Children aged ≥6 to <12 years with severe atopic dermatitis (AD) have limited treatment options. In a 16-week, randomized, placebo-controlled, phase III trial in children, dupilumab, a monoclonal antibody inhibiting interleukin (IL)-4/IL-13 signaling, significantly improved signs and symptoms with acceptable safety; longer-term safety and efficacy data are lacking.
OBJECTIVES


To report the pharmacokinetic profile and long-term safety and efficacy of dupilumab in children (aged ≥6 to <12 years) with severe AD.
METHODS


Children (aged ≥6 to <12 years) with severe AD were enrolled in a global, multicentre, phase IIa, open-label, ascending-dose, sequential-cohort study and subsequent open-label extension (OLE) study. Patients received single-dose dupilumab 2 or 4 mg/kg followed by 8-week pharmacokinetic sampling, then 2 or 4 mg/kg weekly for 4 weeks (phase IIa), followed by the same weekly regimen (OLE). Primary endpoints were dupilumab concentration-time profile and treatment-emergent adverse events (TEAEs); secondary assessments included Eczema Area and Severity Index (EASI) and Peak Pruritus Numeric Rating Scale (PP-NRS) score.
RESULTS


Of 38 children enrolled, 37 completed phase IIa, 33 continued to the OLE. Nonlinear, target-mediated pharmacokinetics characterized dupilumab concentrations (week24-48 mean serum concentrations: 2 mg/kg:61-77 mg/L; 4 mg/kg:143-181 mg/L). TEAEs were mostly mild to moderate and transient; none led to treatment discontinuation. Most commonly reported TEAEs were nasopharyngitis (2 mg/kg:47%; 4 mg/kg:56%) and AD exacerbation (29%/13%). Single-dose dupilumab rapidly improved AD with further improvements through week52. Mean EASI and PP-NRS improved by -37%/-33% and -17%/-20% at week2 (phase IIa) and -92%/-84% and -70%/-58% at week52 (OLE), respectively.
CONCLUSIONS


These safety and efficacy results support use of dupilumab as continuous long-term treatment for children aged ≥6 to <12 years with severe AD.",2020,"Mean EASI and PP-NRS improved by -37%/-33% and -17%/-20% at week2 (phase IIa) and -92%/-84% and -70%/-58% at week52 (OLE), respectively.
","['children aged ≥6 to <12 years with severe AD', 'children (aged ≥6 to <12 years) with severe AD', 'Children aged ≥6 to <12 years with severe atopic dermatitis (AD', 'children aged ≥ 6 to < 12 years with uncontrolled, severe atopic dermatitis', 'Children (aged ≥6 to <12 years) with severe AD were enrolled in a global, multicentre, phase IIa, open-label, ascending-dose, sequential-cohort study and subsequent open-label extension (OLE) study', '38 children enrolled, 37 completed phase IIa, 33 continued to the OLE']","['single-dose dupilumab 2 or 4 mg/kg followed by 8-week pharmacokinetic sampling', 'placebo', 'dupilumab', 'Dupilumab']","['Mean EASI and PP-NRS', 'nasopharyngitis ', 'dupilumab concentration-time profile and treatment-emergent adverse events (TEAEs); secondary assessments included Eczema Area and Severity Index (EASI) and Peak Pruritus Numeric Rating Scale (PP-NRS) score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",38.0,0.11131,"Mean EASI and PP-NRS improved by -37%/-33% and -17%/-20% at week2 (phase IIa) and -92%/-84% and -70%/-58% at week52 (OLE), respectively.
","[{'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity & Cardiovascular Disease, University of Sheffield, Sheffield, U.K.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center of Inflammation Medicine, University of Lübeck, Lubeck, Germany.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': 'Departments of Dermatology and Pediatrics, University of California San Diego School of Medicine, San Diego, CA, U.S.A.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'Arkwright', 'Affiliation': 'Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, U.K.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Basking Ridge, NJ, U.S.A.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, U.S.A.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Akinlade', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, U.S.A.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boklage', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, U.S.A.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Guillemin', 'Affiliation': 'Sanofi, Chilly Mazarin, France.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Kosloski', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, U.S.A.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, U.S.A.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': ""O'Malley"", 'Affiliation': 'Sanofi, Cambridge, MA, U.S.A.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Sanofi, Cambridge, MA, U.S.A.'}, {'ForeName': 'N M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, NY, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.19460']
2715,32969518,Accuracy of arrhythmia detection in implantable cardiac monitors a prospective randomized clinical trial comparing reveal LINQ TM  and confirm Rx TM .,"BACKGROUND


Implantable cardiac monitors (ICMs) are increasingly used to detect arrhythmias in various clinical situations. However, the data transmission time and accuracy of detecting cardiac arrhythmias is unclear.
OBJECTIVE


The objective of this study was to compare the efficiency of data transmission and arrhythmia detection accuracy of the Reveal LINQ TM   with TruRhythm™ Detection with the Confirm Rx TM  with SharpSense™ Technology.
METHODS


In this prospective study, 142 patients were randomized 1:1 to receive Reveal LINQ TM   or Confirm Rx TM  ICM system. Arrhythmic events include atrial fibrillation (AF), pauses and bradycardia. Data transmission time, defined as the time from event occurrence to physician notification. All the arrhythmic events are adjudicated for accuracy.
RESULTS


A total of 3,510 events were transmitted in 61 patients over 7.1 ± 3.5 months. Both the transmission time for all events (448 ± 271 vs 610 ± 515 minutes, p< = 0.02) and for patient activated triggers (24 ± 103 vs 475 ± 426 minutes, p<0.0001) were significantly shorter in the Confirm Rx TM  group. The total number of events was also higher in the Confirm Rx group (25.5 ± 45.6 vs 0.9 ± 1.1 events per patient month, p<0.01) which is likely due to event transmission setting differences between the two groups. Kaplan-Meir analysis showed that the Confirm Rx group detected true arrhythmic episodes sooner with higher percentage of diagnosed patients during 6-month follow-up (p = 0.006). Patient-averaged true positive detection rates were not statistically significant in the two groups (LINQ™ vs Confirm Rx, AF: 52% vs 38%; bradycardia: 67% vs 59%; pause: 24% vs 20%; tachycardia: 81% vs 94%).
CONCLUSION


Compared to the Reveal LINQ™, Confirm Rx™ has shorter event transmission time, more frequent event detections, shorter duration to diagnose true arrhythmic events, and higher percentage of diagnosed patients. The accuracy of arrhythmia detection in both ICMs remains suboptimal. This article is protected by copyright. All rights reserved.",2020,"Patient-averaged true positive detection rates were not statistically significant in the two groups (LINQ™ vs Confirm Rx, AF: 52% vs 38%; bradycardia: 67% vs 59%; pause: 24% vs 20%; tachycardia: 81% vs 94%).
CONCLUSION


",['142 patients'],['Reveal LINQ TM  \xa0or Confirm Rx TM  ICM system'],"['bradycardia', 'true arrhythmic episodes', 'total number of events', 'Arrhythmic events include atrial fibrillation (AF), pauses and bradycardia', 'Patient-averaged true positive detection rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0015350', 'cui_str': 'Matrix, Extracellular'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",142.0,0.0262682,"Patient-averaged true positive detection rates were not statistically significant in the two groups (LINQ™ vs Confirm Rx, AF: 52% vs 38%; bradycardia: 67% vs 59%; pause: 24% vs 20%; tachycardia: 81% vs 94%).
CONCLUSION


","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ip', 'Affiliation': 'Sparrow Clinical Research Institute, Lansing, MI.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Jaffe', 'Affiliation': 'Munson Medical Center, Traverse City, MI.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Castellani', 'Affiliation': 'Sparrow Clinical Research Institute, Lansing, MI.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Sparrow Clinical Research Institute, Lansing, MI.'}, {'ForeName': 'Carson', 'Initials': 'C', 'LastName': 'Castellani', 'Affiliation': 'Michigan State University, East Lansing, MI.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Ip', 'Affiliation': 'Michigan State University, East Lansing, MI.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14076']
2716,32969531,Return to training in the COVID-19 era: The physiological effects of face masks during exercise.,"COVID-19 outbreak has a profound impact on almost every aspect of life. Universal masking is recommended as a means of source control. Routinely exercising in a safe environment is an important strategy for healthy living during this crisis. As sports clubs and public spaces may serve a source of viral transmission, masking may become an integral part of physical activity. This study aimed to assess the physiological effects of wearing surgical masks and N95 respirators during short term strenuous workout. This was a multiple cross-over trial of healthy volunteers. Using a standard cycle ergometry ramp protocol, each subject performed a maximal exercise test without a mask, with a surgical mask, and with an N95 respirator. Physiological parameters and time to exhaustion were compared. Each subject served his own control. Sixteen male volunteers (mean age and BMI of 34 ±4 years and 28.72 ±3.78 kg/m2, respectively) completed the protocol. Heart rate, respiratory rate, blood pressure, oxygen saturation, and time to exhaustion did not differ significantly. Exercising with N95 mask was associated with a significant increase in end-tidal carbon-dioxide (EtCO 2  ) levels. The differences were more prominent as the load increased, reaching 8mmHg at exhaustion (none vs. N95, p=0.001). In conclusion, in healthy subjects, short term moderate-strenuous aerobic physical activity with a mask is feasible, safe, and associated with only minor changes in physiological parameters, particularly a mild increase in EtCO 2  . Subjects suffering from lung diseases should have a cautious evaluation before attempting physical activity with any mask.",2020,"Heart rate, respiratory rate, blood pressure, oxygen saturation, and time to exhaustion did not differ significantly.","['healthy volunteers', 'healthy subjects', 'Sixteen male volunteers (mean age and BMI of 34 ±4 years and 28.72 ±3.78 kg/m2, respectively) completed the protocol', 'Subjects suffering from lung diseases', 'healthy living during this crisis']","['wearing surgical masks and N95 respirators', 'standard cycle ergometry ramp protocol, each subject performed a maximal exercise test without a mask, with a surgical mask, and with an N95 respirator']","['Physiological parameters and time to exhaustion', 'end-tidal carbon-dioxide (EtCO 2  ) levels', 'Heart rate, respiratory rate, blood pressure, oxygen saturation, and time to exhaustion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}]","[{'cui': 'C0181758', 'cui_str': 'Surgical face mask'}, {'cui': 'C0429406', 'cui_str': 'Pattern ERG N95'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C1276408', 'cui_str': 'Ramp protocol'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",16.0,0.0239805,"Heart rate, respiratory rate, blood pressure, oxygen saturation, and time to exhaustion did not differ significantly.","[{'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Epstein', 'Affiliation': 'Internal Medicine ""B"" department, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Korytny', 'Affiliation': 'Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Yoni', 'Initials': 'Y', 'LastName': 'Isenberg', 'Affiliation': 'Internal Medicine ""B"" department, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Erez', 'Initials': 'E', 'LastName': 'Marcusohn', 'Affiliation': 'Department of Cardiology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zukermann', 'Affiliation': 'Department of Cardiology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Boaz', 'Initials': 'B', 'LastName': 'Bishop', 'Affiliation': 'Department of Nephrology, Rambam Medical Center, Haifa, Israel.'}, {'ForeName': ""Sa'ar"", 'Initials': 'S', 'LastName': 'Minha', 'Affiliation': 'Department of Cardiology, Shamir Medical Center, Zerifin, Israel.'}, {'ForeName': 'Aeyal', 'Initials': 'A', 'LastName': 'Raz', 'Affiliation': 'Department of Anesthesiology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Asaf', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'Medical Intensive Care unit, Rambam Health Care Campus, Haifa, Israel.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13832']
2717,32969535,Adaptation to a ketogenic diet modulates adaptive and mucosal immune markers in trained male endurance athletes.,"This study examined the effect of short-term adaptation to a ketogenic diet (KD) on resting and post-exercise immune markers. In a randomised, repeated-measures, cross-over study, eight trained, male, endurance athletes ingested a 31-day low-carbohydrate (CHO), KD (energy intake: 4% CHO; 78% fat) or their habitual diet (HD) (energy intake: 43% CHO; 38% fat). On days 0 and 31, participants ran to exhaustion at 70% VO 2max  . A high-CHO (2 g⋅kg -1  ) meal was ingested prior to the pre-HD, post-HD and pre-KD trials, with CHO (~55 g⋅h -1  ) ingested during exercise. Whereas, a low-CHO (<10 g) meal was ingested prior to the post-KD trial, with fat ingested during exercise. Blood and saliva samples were collected at pre-exercise, exhaustion and 1-h post-exhaustion. T-cell-related cytokine gene expression within peripheral blood mononuclear cells (PBMC) and whole-blood inflammatory cytokine production were determined using 24 h multi-antigen-stimulated whole-blood cultures. Multi-antigen-stimulated PBMC IFN-γ mRNA expression and the IFN-γ/IL-4 mRNA expression ratio were higher at exhaustion in the post- compared with pre-KD trial (p=0.003 and p=0.004); however, IL-4 and IL-10 mRNA expression were unaltered (p>0.05). Multi-antigen-stimulated whole-blood IL-10 production was higher in the post- compared with pre-KD trial (p=0.028); whereas, IL-1β, IL-2, IL-8 and IFN-γ production were lower in the post- compared with pre-HD trial (p<0.01). Salivary immunoglobulin A (SIgA) secretion rate was higher in the post- compared with pre-KD trial (p<0.001). In conclusion, short-term adaptation to a KD in endurance athletes may alter the pro- and anti-inflammatory immune cell cytokine response to a multi-antigen in vitro and SIgA secretion rate.",2020,"Multi-antigen-stimulated whole-blood IL-10 production was higher in the post- compared with pre-KD trial (p=0.028); whereas, IL-1β, IL-2, IL-8 and IFN-γ production were lower in the post- compared with pre-HD trial (p<0.01).",['trained male endurance athletes'],"['short-term adaptation to a ketogenic diet (KD', 'endurance athletes ingested a 31-day low-carbohydrate (CHO), KD (energy intake: 4% CHO; 78% fat) or their habitual diet (HD', 'ketogenic diet']","['Salivary immunoglobulin A (SIgA) secretion rate', 'IL-4 and IL-10 mRNA expression', 'IL-1β, IL-2, IL-8 and IFN-γ production', 'blood IL-10 production', 'T-cell-related cytokine gene expression within peripheral blood mononuclear cells (PBMC) and whole-blood inflammatory cytokine production', 'IFN-γ/IL-4 mRNA expression ratio', 'Blood and saliva samples']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}]","[{'cui': 'C0443735', 'cui_str': 'Salivary immunoglobulin A'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",,0.0371888,"Multi-antigen-stimulated whole-blood IL-10 production was higher in the post- compared with pre-KD trial (p=0.028); whereas, IL-1β, IL-2, IL-8 and IFN-γ production were lower in the post- compared with pre-HD trial (p<0.01).","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Shaw', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Merien', 'Affiliation': 'AUT Roche Diagnostics Laboratory, School of Science, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Braakhuis', 'Affiliation': 'Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Keaney', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Dulson', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13833']
2718,32969541,"Internet-based therapy vs. face-to-face therapy for alcohol use disorder, a randomised controlled non-inferiority trial.","BACKGROUND AND AIM


Most people with alcohol use disorder (AUD) are never treated. Internet-based interventions are effective in reducing alcohol consumption and could help overcome some of the barriers to people not seeking or receiving treatment. The aim of the current study was to compare internet-delivered and face-to-face treatment among adult users with AUD.
DESIGN


Randomized controlled non-inferiority trial with a parallel design, comparing internet-delivered cognitive-behavioural therapy (ICBT) (n=150) with face-to-face CBT (n=151), at three- and six-month follow-ups.
SETTING


A specialized clinic for people with AUD in Stockholm, Sweden. Participants were recruited between 8 December, 2015, and 5 January, 2018.
PARTICIPANTS


301 patients (mean age 50 years [SD 12.3]) with AUD, of whom 115 (38%) were female and 186 (62%) were male.
INTERVENTION AND COMPARATOR


Participants were randomized in blocks of 20 at a ratio of 1:1 to five modules of therapist-guided ICBT or to five modules of face-to-face CBT, delivered over a three-month period. The same treatment material and the same therapists were used in both groups.
MEASUREMENTS


The primary outcome was standard drinks of alcohol consumed during the previous week at six-month follow-up, analysed according to intention-to-treat. The prespecified non-inferiority limit was 5 standard drinks of alcohol and d=0.32 for secondary outcomes.
RESULTS


The difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the six-month follow-up (internet=12.33 and face-to-face=11.43, difference=0.89, 95 CI=-1.1 to 2.88). The secondary outcome, Alcohol Use Disorder Identification Test score, failed to show non-inferiority of internet compared with face-to-face in the intention-to-treat analysis at six-month follow-up (internet=12.26 and face-to-face=11.57, d=0.11, 95 CI=-0.11 to 0.34).
CONCLUSIONS


Internet-delivered treatment was non-inferior to face-to-face treatment in reducing alcohol consumption among help-seeking patients with alcohol use disorder but failed to show non-inferiority on some secondary outcomes.",2020,"The difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the six-month follow-up (internet=12.33 and face-to-face=11.43,","['Participants were recruited between 8 December, 2015, and 5 January, 2018', 'adult users with AUD', 'people with alcohol use disorder (AUD', 'A specialized clinic for people with AUD in Stockholm, Sweden', '301 patients (mean age 50 years [SD 12.3]) with AUD, of whom 115 (38%) were female and 186 (62%) were male']","['internet-delivered cognitive-behavioural therapy (ICBT) (n=150) with face-to-face CBT', 'therapist-guided ICBT or to five modules of face-to-face CBT', 'Internet-based therapy vs. face-to-face therapy']","['alcohol consumption', 'standard drinks of alcohol', 'Alcohol Use Disorder Identification Test score, failed to show non-inferiority of internet compared with face-to-face in the intention-to-treat analysis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C2732658', 'cui_str': 'Alcohol use disorders identification test score'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]",,0.0935829,"The difference in alcohol consumption between the internet and the face-to-face group was non-inferior in the intention-to-treat analysis of data from the six-month follow-up (internet=12.33 and face-to-face=11.43,","[{'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Johansson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Sinadinovic', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Gajecki', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Lindner', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Berman', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ulric', 'Initials': 'U', 'LastName': 'Hermansson', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Andreasson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}]","Addiction (Abingdon, England)",['10.1111/add.15270']
2719,32969562,Mindfulness training preserves sustained attention and resting state anticorrelation between default-mode network and dorsolateral prefrontal cortex: A randomized controlled trial.,"Mindfulness training can enhance cognitive control, but the neural mechanisms underlying such enhancement in children are unknown. Here, we conducted a randomized controlled trial (RCT) with sixth graders (mean age 11.76 years) to examine the impact of 8 weeks of school-based mindfulness training, relative to coding training as an active control, on sustained attention and associated resting-state functional brain connectivity. At baseline, better performance on a sustained-attention task correlated with greater anticorrelation between the default mode network (DMN) and right dorsolateral prefrontal cortex (DLPFC), a key node of the central executive network. Following the interventions, children in the mindfulness group preserved their sustained-attention performance (i.e., fewer lapses of attention) and preserved DMN-DLPFC anticorrelation compared to children in the active control group, who exhibited declines in both sustained attention and DMN-DLPFC anticorrelation. Further, change in sustained-attention performance correlated with change in DMN-DLPFC anticorrelation only within the mindfulness group. These findings provide the first causal link between mindfulness training and both sustained attention and associated neural plasticity. Administered as a part of sixth graders' school schedule, this RCT supports the beneficial effects of school-based mindfulness training on cognitive control.",2020,"At baseline, better performance on a sustained-attention task correlated with greater anticorrelation between the default mode network (DMN) and right dorsolateral prefrontal cortex (DLPFC), a key node of the central executive network.",['sixth graders (mean age 11.76\u2009years'],"['Mindfulness training', 'school-based mindfulness training', 'school-based mindfulness training, relative to coding training as an active control']","['sustained attention and resting state anticorrelation', 'sustained-attention performance', 'lapses of attention) and preserved DMN-DLPFC anticorrelation']","[{'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]",,0.028885,"At baseline, better performance on a sustained-attention task correlated with greater anticorrelation between the default mode network (DMN) and right dorsolateral prefrontal cortex (DLPFC), a key node of the central executive network.","[{'ForeName': 'Clemens C C', 'Initials': 'CCC', 'LastName': 'Bauer', 'Affiliation': 'Department of Brain and Cognitive Sciences and McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Liron', 'Initials': 'L', 'LastName': 'Rozenkrantz', 'Affiliation': 'Department of Brain and Cognitive Sciences and McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Caballero', 'Affiliation': 'Department of Brain and Cognitive Sciences and McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Nieto-Castanon', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, Massachusetts, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Scherer', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'West', 'Affiliation': 'Harvard Graduate School of Education, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mrazek', 'Affiliation': 'Department of Psychological and Brain Sciences, University of California, Santa Barbara, California, USA.'}, {'ForeName': 'Dawa T', 'Initials': 'DT', 'LastName': 'Phillips', 'Affiliation': 'Empowerment Holdings, Santa Barbara, California, USA.'}, {'ForeName': 'John D E', 'Initials': 'JDE', 'LastName': 'Gabrieli', 'Affiliation': 'Department of Brain and Cognitive Sciences and McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Whitfield-Gabrieli', 'Affiliation': 'Department of Brain and Cognitive Sciences and McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}]",Human brain mapping,['10.1002/hbm.25197']
2720,32969563,Cabozantinib plus Docetaxel and Prednisone in Metastatic Castrate Resistant Prostate Cancer.,"OBJECTIVE


To evaluate the safety and efficacy of cabozantinib combined with docetaxel.
SUBJECTS AND METHODS


This was a phase 1/2 multicenter study in patients with mCRPC. Docetaxel (75 mg/m 2  every 3 weeks with daily prednisone 10 mg) was combined with escalating doses of daily cabozantinib (20, 40, and 60 mg). Based on the results of the phase 1 study, the investigation was expanded into a randomized study of docetaxel/prednisone with the maximum tolerated dose (MTD) of cabozantinib vs. docetaxel/prednisone.
RESULTS


A total of 44 men with mCRPC were enrolled on this phase 1/2 trial. The MTD=40 mg cabozantinib with docetaxel was determined. Dose limiting toxicities were neutropenic fever and palmer-plantar erythrodysesthesia and there was 1 death due to a thromboembolic event. In addition, grade 3 or 4 myelosuppression, hypophosphatemia, and neuropathy were seen in 3 or more patients. In the phase 1, the median time to progression (TTP) and overall survival was 13.6 and 16.3 months, respectively. In the phase 2 study, which was terminated early due to poor accrual, median TTP and overall survival favored the combination (n=13) compared to docetaxel/prednisone (n=12; 21.0 vs. 6.6 months; p=0.035 and 23.8 vs. 15.6 months; p=0.072, respectively).
CONCLUSION


Despite the limited number of patients in this study, preliminary data suggests cabozantinib can be safely added to docetaxel with possible enhanced efficacy.",2020,Dose limiting toxicities were neutropenic fever and palmer-plantar erythrodysesthesia and there was 1 death due to a thromboembolic event.,"['Metastatic Castrate Resistant Prostate Cancer', 'patients with mCRPC', '44 men with mCRPC']","['cabozantinib vs. docetaxel/prednisone', 'Cabozantinib plus Docetaxel and Prednisone', 'cabozantinib combined with docetaxel', 'docetaxel', 'Docetaxel', 'docetaxel/prednisone']","['median time to progression (TTP) and overall survival', 'median TTP and overall survival', 'neutropenic fever and palmer-plantar erythrodysesthesia', 'safety and efficacy', 'grade 3 or 4 myelosuppression, hypophosphatemia, and neuropathy']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}]",44.0,0.0319574,Dose limiting toxicities were neutropenic fever and palmer-plantar erythrodysesthesia and there was 1 death due to a thromboembolic event.,"[{'ForeName': 'Ravi A', 'Initials': 'RA', 'LastName': 'Madan', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'Fatima H', 'Initials': 'FH', 'LastName': 'Karzai', 'Affiliation': 'National Cancer Institute, NIH, USA.'}, {'ForeName': 'Munjid', 'Initials': 'M', 'LastName': 'Al Harthy', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Yale School of Medicine, USA.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Yale School of Medicine, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Arlen', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Rosner', 'Affiliation': 'Walter Reed National Military Medical Center, Center for Prostate Disease Research, USA.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cordes', 'Affiliation': 'National Cancer Institute, NIH, USA.'}, {'ForeName': 'Marijo', 'Initials': 'M', 'LastName': 'Bilusic', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'Cody J', 'Initials': 'CJ', 'LastName': 'Peer', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Dawson', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Washington, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Couvillon', 'Affiliation': 'National Cancer Institute, NIH, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hankin', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'Moniquea', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'Guin', 'Initials': 'G', 'LastName': 'Chun', 'Affiliation': 'National Cancer Institute, NIH, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Owens', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Marte', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'Min-Jung', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Developmental Therapeutics Branch, USA.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Developmental Therapeutics Branch, USA.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yuno', 'Affiliation': 'Developmental Therapeutics Branch, USA.'}, {'ForeName': 'Jane B', 'Initials': 'JB', 'LastName': 'Trepel', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'Sunmin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Developmental Therapeutics Branch, USA.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Biostatistics and Data Management Section, Center for Cancer Research, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Dahut', 'Affiliation': 'Genitourinary Malignacies Branch, Bethesda, USA.'}]",BJU international,['10.1111/bju.15227']
2721,32967762,[Down-regulation of SIRT1 and PGC-1α expression caused by hyperoxia induces mitochondrial dysfunction in human alveolar epithelial cells].,"Objective To investigate SIRT1-PGC-1α signaling pathway-mediated effect of hyperoxia on mitochondrial function in A549 human alveolar epithelial cells and its possible mechanism. Methods Human alveolar epithelial cells in logarithmic growth phase were randomly divided into control group and hyperoxia group. The control group was cultured in a 37DegreesCelsius, 50 mL/L CO 2  saturated humidity incubator, and the hyperoxia group was treated with 950 mL/L O 2 . Following 24-hour culture, Mito SOX TM  staining was used to detect the level of mitochondrial reactive oxygen species (Mito-ROS) and JC-1 staining to detect the mitochondrial membrane potential. Real-time quantitative PCR was performed to detect the mitochondrial DNA content and the mRNA levels of SIRT1, PGC-1α, nuclear respiratory factor 1 (NRF1) and mitochondrial transcription factor A (TFAM), and Western blotting to detect the protein levels of SIRT1, PGC-1α, NRF1 and TFAM. Results Compared with the control group, the Mito-ROS of the hyperoxia group increased significantly, while the membrane potential decreased obviously; the mitochondrial DNA content of the hyperoxia group went down, and the mRNA and protein expression of SIRT1, PGC-1α, NRF1 and TFAM dropped. Conclusion Hyperoxia induces mitochondrial dysfunction in human alveolar epithelial cells by inhibiting the expression of SIRT1 and PGC-1α.",2020,"Compared with the control group, the Mito-ROS of the hyperoxia group increased significantly, while the membrane potential decreased obviously; the mitochondrial DNA content of the hyperoxia group went down, and the mRNA and protein expression of SIRT1, PGC-1α, NRF1 and TFAM dropped.","['A549 human alveolar epithelial cells', 'human alveolar epithelial cells', 'Methods Human alveolar epithelial cells in logarithmic growth phase']",['hyperoxia'],"['mitochondrial DNA content and the mRNA levels of SIRT1, PGC-1α, nuclear respiratory factor 1 (NRF1) and', 'mRNA and protein expression of SIRT1, PGC-1α, NRF1 and TFAM dropped', 'Mito-ROS', 'mitochondrial DNA content']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0225698', 'cui_str': 'Pneumocyte'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0242706', 'cui_str': 'Hyperoxia'}]","[{'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C1565068', 'cui_str': 'NRF1 Transcription Factor'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}]",,0.0199608,"Compared with the control group, the Mito-ROS of the hyperoxia group increased significantly, while the membrane potential decreased obviously; the mitochondrial DNA content of the hyperoxia group went down, and the mRNA and protein expression of SIRT1, PGC-1α, NRF1 and TFAM dropped.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China.'}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Newborn Medicine, Affiliated Hospital of Southwest Medical University, Birth Defects Clinical Medical Research Center of Sichuan Province, Luzhou 646000, China. *Corresponding author, E-mail: dongwenbin2000@163.com.'}]",Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology,[]
2722,32967775,Effect of Icosapent Ethyl on Gynoid Fat and Bone Mineral Health in the Metabolic Syndrome: a Preliminary Report.,"PURPOSE


The metabolic syndrome (MetS) is a systemic disorder associated with reduced atheroprotective gynoid fat and bone mineral content (BMC). The goal of this pilot study was to assess whether administration of icosapent ethyl (IPE), a purified formulation of eicosapentaenoic acid, would maintain gynoid fat and BMC over a 9-month treatment period.
METHODS


Patients with MetS aged ≥40 years were randomly assigned to receive 4 g daily of IPE (2 g BID with food) or placebo (paraffin oil 2 g BID with food) for 9 months. Data were collected at baseline and 9 months later. The data included anthropometric measures, biochemical analysis, and whole body fat mass, including gynoid fat. Bone mineral density and BMC were measured by using dual-energy X-ray absorptiometry. A two-tailed P value ≤ 0.05 was considered statistically significant.
FINDINGS


The study sample consisted of 13 patients with MetS (mean age, 61.6 years; age range, 44-77 years; 77% female and 23% male). Compared with the IPE group, the placebo group experienced statistically significant mean reductions in percent gynoid fat (pre/post, 46.8%-43.5%; P = 0.02), BMC (pre/post, 2461 g-2423 g; P = 0.02), and bone mineral density (pre/post, 1.24 g/cm 2  to 1.22 g/cm 2 ; P = 0.05) over the 9-month study period.
IMPLICATIONS


The results of this pilot study raise the possibility that IPE supplementation may preserve gynoid fat distribution and bone mineral health in patients with MetS. Larger, randomized longitudinal studies are necessary to determine the potential long-term metabolic benefits of IPE treatment.",2020,"Compared with the IPE group, the placebo group experienced statistically significant mean reductions in percent gynoid fat (pre/post, 46.8%-43.5%; P = 0.02), BMC (pre/post, 2461 ","['g-2423', 'Metabolic Syndrome', '13 patients with MetS (mean age, 61.6 years; age range, 44-77 years; 77% female and 23% male', 'patients with MetS', 'Patients with MetS aged ≥40 years']","['icosapent ethyl (IPE', 'Icosapent Ethyl', 'placebo (paraffin oil 2', 'IPE supplementation', 'IPE', 'eicosapentaenoic acid', 'placebo']","['bone mineral density', 'BMC', 'Gynoid Fat and Bone Mineral Health', 'Bone mineral density and BMC', 'gynoid fat distribution and bone mineral health', 'percent gynoid fat']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026156', 'cui_str': 'Mineral Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0424629', 'cui_str': 'Peripheral obesity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",13.0,0.0814381,"Compared with the IPE group, the placebo group experienced statistically significant mean reductions in percent gynoid fat (pre/post, 46.8%-43.5%; P = 0.02), BMC (pre/post, 2461 ","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: mmiller@som.umaryland.edu.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Ryan', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA; Baltimore VA Geriatric Research, Education and Clinical Center, Baltimore, MD, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Reed', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Goggins', 'Affiliation': 'Department of Medicine, Georgetown University School of Medicine, Washington, DC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sorkin', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA; Baltimore VA Geriatric Research, Education and Clinical Center, Baltimore, MD, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA; Baltimore VA Geriatric Research, Education and Clinical Center, Baltimore, MD, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.09.005']
2723,32967799,"A phase 3, double-blind, parallel-group study to evaluate the efficacy and safety of tezacaftor in combination with ivacaftor in participants 6 through 11 years of age with cystic fibrosis homozygous for F508del or heterozygous for the F508del-CFTR mutation and a residual function mutation.","BACKGROUND


The CFTR modulator tezacaftor/ivacaftor was efficacious and generally safe and well tolerated in Phase 3 studies in participants ≥12 years of age with cystic fibrosis (CF) homozygous for the F508del-CFTR mutation or heterozygous with a residual function-CFTR mutation (F/F or F/RF respectively). We evaluated tezacaftor/ivacaftor's efficacy and safety over 8 weeks in participants 6 through 11 years of age with these mutations.
METHODS


Participants were randomized 4:1 to tezacaftor/ivacaftor or a blinding group (placebo for F/F, ivacaftor for F/RF). The primary endpoint was within-group change from baseline in the lung clearance index 2·5 (LCI 2·5 ) through Week 8. Secondary endpoints were change from baseline in sweat chloride (SwCl), cystic fibrosis questionnaire-revised (CFQ-R) respiratory domain score, and safety.
RESULTS


Sixty-seven participants received at least one study drug dose. Of those, 54 received tezacaftor/ivacaftor (F/F, 42; F/RF, 12), 10 placebo, and 3 ivacaftor; 66 completed the study. The within-group change in LCI 2·5  was significantly reduced (improved) by -0·51 (95% CI: -0·74, -0·29). SwCl concentration decreased (improved) by -12·3 mmol/L and CFQ-R respiratory domain score increased (improved, nonsignificantly) by 2·3 points. There were no serious adverse events (AEs) or AEs leading to tezacaftor/ivacaftor discontinuation or interruption. The most common AEs (≥10%) in participants receiving tezacaftor/ivacaftor were cough, headache, and productive cough.
CONCLUSIONS


Tezacaftor/ivacaftor improved lung function (assessed using LCI) and CFTR function (measured by SwCl concentration) in participants 6 through 11 years of age with F/F or F/RF genotypes. Tezacaftor/ivacaftor was safe and well tolerated; no new safety concerns were identified.",2020,There were no serious adverse events (AEs) or AEs leading to tezacaftor/ivacaftor discontinuation or interruption.,"['participants ≥12 years of age with cystic fibrosis (CF) homozygous for the F508del-CFTR mutation or heterozygous with a residual function-CFTR mutation (F/F or F/RF respectively', 'Participants', 'participants 6 through 11 years of age with cystic fibrosis homozygous for F508del or heterozygous for the F508del-CFTR mutation and a residual function mutation', 'participants 6 through 11 years of age with these mutations']","['0·51', 'tezacaftor/ivacaftor', 'ivacaftor', 'Tezacaftor/ivacaftor', 'tezacaftor/ivacaftor or a blinding group (placebo for F/F, ivacaftor for F/RF', 'tezacaftor']","['safe and well tolerated; no new safety concerns', 'lung clearance index 2·5', 'CFQ-R respiratory domain score', 'SwCl concentration', 'efficacy and safety', 'cough, headache, and productive cough', 'LCI 2·5', 'change from baseline in sweat chloride (SwCl), cystic fibrosis questionnaire-revised (CFQ-R) respiratory domain score, and safety', 'lung function (assessed using LCI) and CFTR function', 'serious adverse events (AEs) or AEs leading to tezacaftor/ivacaftor discontinuation or interruption']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0855766', 'cui_str': 'Residual function'}]","[{'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0239134', 'cui_str': 'Productive cough'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",6.0,0.131127,There were no serious adverse events (AEs) or AEs leading to tezacaftor/ivacaftor discontinuation or interruption.,"[{'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Davies', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom. Electronic address: j.c.davies@imperial.ac.uk.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Sermet-Gaudelus', 'Affiliation': 'INSERM U1151, Institut Necker Enfants Malades, Université Paris Sorbonne, Paris, France, Hôpital Necker-Enfants malades, Paris, France.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Naehrlich', 'Affiliation': 'Department of Pediatrics, Justus Liebig University Giessen, Giessen, Germany; Universities of Giessen and Marburg Lung Center, The German Center for Lung Research, Giessen, Germany.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Harris', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Short', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Haseltine', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Panorchan', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Owen', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, United States.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Wainwright', 'Affiliation': 'The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.07.023']
2724,32967805,Effects of home-based inspiratory muscle training on sickle cell disease (SCD) patients.,"INTRODUCTION


Inspiratory muscle training (IMT) has been shown to be an efficient method of improving exercise tolerance and inspiratory and expiratory muscle strength in several diseases. The effects of IMT on patients with sickle cell anemia (SCD) are relatively unknown. Our study aimed to evaluate the effects of IMT on adult SCD patients, regarding respiratory muscle strength (RMS) variables, lung function, exercise tolerance, blood lactation concentration, limitation imposed by dyspnea during daily activities and impact of fatigue on the quality of life.
METHODS


This was a randomized single-blind study, with an IMT design comprising true load (TG) and sham load (SG) groups. Initial assessment included spirometry, volumetric capnography (VCap) and measurement of RMS by maximal inspiratory and expiratory pressure (PImax and PEmax). The Medical Research Council dyspnea scale and modified fatigue impact scale were also applied and blood lactate concentration was measured before and after the 6-minute walk test. After this initial assessment, the patient used the IMT device at home daily, returning every 6 weeks for RMS reassessment. Both groups used the same device and were unaware of which group they were in. After a period totaling 18 weeks, patients underwent the final evaluation, as initially performed.
RESULTS


Twenty-five patients in total participated until the end of the study (median age 42 years). There were no significant differences between TG and SG based on age, sex, body mass index or severity of genotype. At the end of the training, both groups showed a significant increase in PEmax and PImax, improvement in Vcap and in exercise tolerance and dyspnea reduction while performing daily life activities. The same was observed in patients grouped according to disease severity (HbSS and HbSβ 0 vs HbSC and HbSβ + ), without differences between groups.
CONCLUSION


Home-based inspiratory muscle training benefits outpatients with SCD, including the sham load group.
TRIAL REGISTRATION


http://www.ensaiosclinicos.gov.br; registration number: RBR-6g8n92.",2020,"At the end of the training, both groups showed a significant increase in PEmax and PImax, improvement in Vcap and in exercise tolerance and dyspnea reduction while performing daily life activities.","['Twenty-five patients in total participated until the end of the study (median age 42 years', 'sickle cell disease (SCD) patients', 'patients with sickle cell anemia (SCD', 'adult SCD patients']","['IMT design comprising true load (TG) and sham load (SG', 'IMT', 'home-based inspiratory muscle training', 'Inspiratory muscle training (IMT', 'Home-based inspiratory muscle training']","['respiratory muscle strength (RMS) variables, lung function, exercise tolerance, blood lactation concentration, limitation imposed by dyspnea during daily activities and impact of fatigue on the quality of life', 'Medical Research Council dyspnea scale and modified fatigue impact scale', 'Initial assessment included spirometry, volumetric capnography (VCap) and measurement of RMS by maximal inspiratory and expiratory pressure (PImax and PEmax', 'PEmax and PImax, improvement in Vcap and in exercise tolerance and dyspnea reduction', 'blood lactate concentration']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0376529', 'cui_str': 'Capnography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",,0.0308916,"At the end of the training, both groups showed a significant increase in PEmax and PImax, improvement in Vcap and in exercise tolerance and dyspnea reduction while performing daily life activities.","[{'ForeName': 'Fábio', 'Initials': 'F', 'LastName': 'Galvão', 'Affiliation': 'Universidade Estadual Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Camila Tatiana', 'Initials': 'CT', 'LastName': 'Zanoni', 'Affiliation': 'Universidade Estadual Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Marcos Mello', 'Initials': 'MM', 'LastName': 'Moreira', 'Affiliation': 'Universidade Estadual Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Ilma Aparecida', 'Initials': 'IA', 'LastName': 'Paschoal', 'Affiliation': 'Universidade Estadual Campinas (UNICAMP), Campinas, SP, Brazil.'}, {'ForeName': 'Sara Teresinha Olalla', 'Initials': 'STO', 'LastName': 'Saad', 'Affiliation': 'Universidade Estadual Campinas (UNICAMP), Campinas, SP, Brazil. Electronic address: sara@unicamp.br.'}]","Hematology, transfusion and cell therapy",['10.1016/j.htct.2020.08.005']
2725,32967939,MRI and 18FET-PET predict survival benefit from bevacizumab plus radiotherapy in patients with IDH wild-type glioblastoma: results from the randomized ARTE trial.,"PURPOSE


To explore a prognostic or predictive role of magnetic resonance imaging (MRI) and O-(2- 18 F-fluoroethyl)-L-tyrosine ( 18 FET) positron emission tomography (PET) parameters for outcome in the randomized multi-center trial ARTE that compared bevacizumab plus radiotherapy with radiotherpay alone in elderly patients with glioblastoma.
EXPERIMENTAL DESIGN


Patients with isocitrate dehydrogenase wild-type glioblastoma aged 65 years or older were included in this post-hoc analysis. Tumor volumetric and apparent diffusion coefficient (ADC) analyses of serial MRI scans from 67 patients and serial  18 FET-PET tumor-to-brain intensity ratios (TBR) from 31 patients were analyzed blinded for treatment arm and outcome. Multivariate Cox regression analysis was done to account for established prognostic factors and treatment arm.
RESULTS


Overall survival benefit from bevacizumab plus radiotherapy compared to radiotherapy alone was observed for larger pre-treatment MRI contrast-enhancing tumor (hazard ratio [HR] per cm 3  0.94, 95% confidence interval [CI] 0.89-0.99) and for higher ADC (HR 0.18, CI 0.05-0.66). Higher  18 FET-TBR on pre-treatment PET scans was associated with inferior overall survival in both arms. Response assessed by standard MRI-based RANO criteria was associated with overall survival in the bevacizumab plus radiotherapy arm by trend only (p=0.09). High  18 FET-TBR of non-contrast-enhancing tumor portions during bevacizumab therapy was associated with inferior overall survival on multivariate analysis (HR 5.97, CI 1.16-30.8).
CONCLUSION


Large pre-treatment contrast-enhancing tumor mass and higher ADC identify patients who may experience a survival benefit from bevacizumab plus radiotherapy. Persistent  18 FET-PET signal of no longer contrast-enhancing tumor after concomitant bevacizumab plus radiotherapy suggests pseudoresponse and predicts poor outcome.
TRIAL REGISTRATION


NCT01443676.",2020,"High  18 FET-TBR of non-contrast-enhancing tumor portions during bevacizumab therapy was associated with inferior overall survival on multivariate analysis (HR 5.97, CI 1.16-30.8).
","['67 patients and serial  18 FET-PET tumor-to-brain intensity ratios (TBR) from 31 patients', 'patients with IDH wild-type glioblastoma', 'Patients with isocitrate dehydrogenase wild-type glioblastoma aged 65 years or older', 'elderly patients with glioblastoma']","['magnetic resonance imaging (MRI) and O-(2- 18 F-fluoroethyl)-L-tyrosine ( 18 FET) positron emission tomography (PET', 'bevacizumab plus radiotherapy with radiotherpay alone', 'bevacizumab', 'bevacizumab plus radiotherapy', 'radiotherapy']","['inferior overall survival', 'Overall survival benefit', 'Tumor volumetric and apparent diffusion coefficient (ADC) analyses of serial MRI scans', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0643582', 'cui_str': '11-(2-fluoroethyl)estradiol'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0302995', 'cui_str': 'Fluorine-18'}, {'cui': 'C0041485', 'cui_str': 'Tyrosine'}, {'cui': 'C0643582', 'cui_str': '11-(2-fluoroethyl)estradiol'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",31.0,0.381841,"High  18 FET-TBR of non-contrast-enhancing tumor portions during bevacizumab therapy was associated with inferior overall survival on multivariate analysis (HR 5.97, CI 1.16-30.8).
","[{'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Wirsching', 'Affiliation': 'Neurology, University Hospital of Zurich hans-georg.wirsching@usz.ch.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Roelcke', 'Affiliation': 'Cantonal Hospital Aarau.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weller', 'Affiliation': 'Neurosurgery, Medical Center of the University of Munich.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hundsberger', 'Affiliation': 'Department of Neurology and hematology/oncology, Cantonal Hospital St Gallen.'}, {'ForeName': 'Andreas Felix', 'Initials': 'AF', 'LastName': 'Hottinger', 'Affiliation': 'University Hospital of Lausanne.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'von Moos', 'Affiliation': 'Kantonsspital Chur, Mediacal Oncology and Hematology.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Caparrotti', 'Affiliation': 'University Hospital of Geneva.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Conen', 'Affiliation': 'Medicine, McMaster University.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Remonda', 'Affiliation': 'Cantonal Hospital Aarau.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Roth', 'Affiliation': 'Laboratory of Molecular Neuro-Oncology, Department of Neurology, University Hospital and University of Zurich.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Ochsenbein', 'Affiliation': 'Universitätsklinik und Poliklinik für Medizinische Onkologie, Inselspital.'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Tabatabai', 'Affiliation': 'Neurology & Neurooncology, Eberhard Karls University & University Hospital Tübingen.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Laboratory of Molecular Neuro-Oncology, Department of Neurology, University Hospital and University of Zurich.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2096']
2726,32967974,A stepped-wedge randomized trial and qualitative survey of HIV pre-exposure prophylaxis uptake in the Eswatini population.,"Clinical trials have shown that antiretroviral drugs used as pre-exposure prophylaxis (PrEP) are highly effective for preventing HIV acquisition. PrEP efforts, including in sub-Saharan Africa, have almost exclusively focused on certain priority groups, particularly female sex workers, men having sex with men, pregnant women, serodiscordant couples, and young women. As part of a PrEP demonstration project involving the general population at six primary health care facilities in Eswatini (formerly Swaziland), we conducted a randomized trial of a health care facility-based PrEP promotion package designed to increase PrEP uptake. Over the 18-month study duration, 33.6% (517 of 1538) of adults identified by health care workers as being at risk of acquiring HIV took up PrEP, and 30.0% of these individuals attended all scheduled appointments during the first 6 months after initiation of PrEP. The PrEP promotion package was associated with a 55% (95% confidence interval, 15 to 110%;  P  = 0.036) relative increase in the number of individuals taking up PrEP, with an absolute increase of 2.2 individuals per month per health care facility. When asked how PrEP uptake could be improved in 217 accompanying in-depth qualitative interviews, interviewees recommended an expansion of PrEP promotion activities beyond health care facilities to communities. Although a health care facility-based promotion package improved PrEP uptake, both uptake and retention remained low. Expanding promotion activities to the community is needed to achieve greater PrEP coverage among adults at risk of HIV infection in Eswatini and similar settings.",2020,"The PrEP promotion package was associated with a 55% (95% confidence interval, 15 to 110%;  P  = 0.036) relative increase in the number of individuals taking up PrEP, with an absolute increase of 2.2 individuals per month per health care facility.","['Eswatini population', 'female sex workers, men having sex with men, pregnant women, serodiscordant couples, and young women', 'general population at six primary health care facilities in Eswatini (formerly Swaziland']",['health care facility-based PrEP promotion package'],['PrEP uptake'],"[{'cui': 'C0038983', 'cui_str': 'Swaziland'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]",,0.0278846,"The PrEP promotion package was associated with a 55% (95% confidence interval, 15 to 110%;  P  = 0.036) relative increase in the number of individuals taking up PrEP, with an absolute increase of 2.2 individuals per month per health care facility.","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Geldsetzer', 'Affiliation': 'Division of Primary Care and Population Health, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94035, USA. till.baernighausen@uni-heidelberg.de pgeldsetzer@stanford.edu.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hettema', 'Affiliation': 'Clinton Health Access Initiative, Mbabane H100, Eswatini.'}, {'ForeName': 'Shannon A', 'Initials': 'SA', 'LastName': 'McMahon', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Dalal', 'Affiliation': 'Department of Global HIV, Hepatitis and STI Programmes, World Health Organization, CH-1211 Geneva 27, Switzerland.'}, {'ForeName': 'Rachel P', 'Initials': 'RP', 'LastName': 'Chase', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA 94115, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kohler', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Simiao', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany.'}, {'ForeName': 'Phiwayinkhosi', 'Initials': 'P', 'LastName': 'Dlamini', 'Affiliation': 'Clinton Health Access Initiative, Mbabane H100, Eswatini.'}, {'ForeName': 'Mxolisi', 'Initials': 'M', 'LastName': 'Mavuso', 'Affiliation': 'Clinton Health Access Initiative, Mbabane H100, Eswatini.'}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Hughey', 'Affiliation': 'Clinton Health Access Initiative, Mbabane H100, Eswatini.'}, {'ForeName': 'Sindy', 'Initials': 'S', 'LastName': 'Matse', 'Affiliation': 'Eswatini National AIDS Programme, Ministry of Health, Government of the Kingdom of Eswatini, Mbabane H100, Eswatini.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Heidelberg Institute of Global Health (HIGH), Heidelberg University, 69120 Heidelberg, Germany. till.baernighausen@uni-heidelberg.de pgeldsetzer@stanford.edu.'}]",Science translational medicine,['10.1126/scitranslmed.aba4487']
2727,32968038,Effectiveness of workplace intervention strategies in lower back pain prevention: a review.,"The aim of this study was to identify effective work place intervention strategies for the prevention of low back pain (LBP). The study focused on interventions to two major groups: personal interventions and technical interventions. Data basis were searched for with inclusion criteria: study design based on randomised controlled trial; outcome measures including non-specific LBP occurrence expressed by prevalence or intensity; intervention met the definition of the technical and/or personal (physical exercises, behavioural training, educational) intervention programme. Eighteen papers were selected for full analysis. The diversification of quantitative indicators of differences between control and intervention groups were carried out using Cohen's d index. The results of analysis showed strong differences in effects among intervention strategies, as well as among different cases within similar intervention strategies. LBP severity before intervention and the length of intervention were discussed as potentially influencing factors. The results of the analysis suggest that the most effective strategies for LBP prevention include technical modifications of the workstand and education based on practical training. Behavioural and physical training seems to be of lesser importance. LBP severity before intervention and the time when the measurements of outcome measures take place play an important role in the effectiveness of intervention.",2020,"The results of analysis showed strong differences in effects among intervention strategies, as well as among different cases within similar intervention strategies.","['Eighteen papers were selected for full analysis', 'lower back pain prevention', 'low back pain (LBP']","['Behavioural and physical training', 'technical and/or personal (physical exercises, behavioural training, educational) intervention programme', 'personal interventions and technical interventions', 'workplace intervention strategies']",['LBP severity'],"[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",18.0,0.0243982,"The results of analysis showed strong differences in effects among intervention strategies, as well as among different cases within similar intervention strategies.","[{'ForeName': 'Roman-Liu', 'Initials': 'RL', 'LastName': 'Danuta', 'Affiliation': 'Central Institute for Labour Protection - National Research Institute (CIOP-PIB), Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'KamiŃska', 'Affiliation': 'Central Institute for Labour Protection - National Research Institute (CIOP-PIB), Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Tokarski', 'Affiliation': 'Central Institute for Labour Protection - National Research Institute (CIOP-PIB), Poland.'}]",Industrial health,['10.2486/indhealth.2020-0130']
2728,32968158,Effect of cholecalciferol on serum hepcidin and parameters of anaemia and CKD-MBD among haemodialysis patients: a randomized clinical trial.,"In this multicentre double-blind randomized clinical trial, we investigated the effects of oral cholecalciferol supplementation on serum hepcidin and parameters related to anaemia and CKD-MBD among haemodialysis patients. Participants were assigned in a 2:2:1:1 ratio to either (1) thrice-weekly 3,000-IU cholecalciferol, (2) once-monthly cholecalciferol (equivalent to 9,000 IU/week), (3) thrice-weekly placebo, or (4) once-monthly placebo. We also examined the effect modifications by selected single nucleotide polymorphisms in vitamin D-related genes. Out of 96 participants, 94 were available at Month 3, and 88 completed the 6-month study. After adjustment for baseline values, serum hepcidin levels were higher at Day 3 in the combined cholecalciferol (vs. placebo) group, but were lower at Month 6 with increased erythropoietin resistance. Cholecalciferol increased serum 1,25(OH) 2 D levels, resulting in a greater proportion of patients who reduced the dose of active vitamin D at Month 6 (31% vs. 10% in the placebo group). Cholecalciferol also suppressed intact PTH only among patients with severe vitamin D deficiency. In conclusion, cholecalciferol supplementation increases serum hepcidin-25 levels in the short term and may increase erythropoietin resistance in the long term among haemodialysis patients. Both thrice-weekly and once-monthly supplementation effectively increases serum 1,25(OH) 2 D levels, and hence, reduces active vitamin D drugs.Clinical Trial Registry: This study was registered at ClinicalTrials.gov and University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) as NCT02214563 (registration date: 12/08/2014) and UMIN000011786 (registration date: 15/08/2014), respectively (please refer to the links below). ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/record/NCT02214563 . UMIN-CTR: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000017152&language=E .",2020,"Both thrice-weekly and once-monthly supplementation effectively increases serum 1,25(OH) 2 D levels, and hence, reduces active vitamin D drugs.","['96 participants, 94 were available at Month 3, and 88 completed the 6-month study', 'haemodialysis patients', 'patients with severe vitamin D deficiency']","['combined cholecalciferol (vs. placebo', 'cholecalciferol', 'placebo, or (4) once-monthly placebo', 'oral cholecalciferol supplementation', 'thrice-weekly 3,000-IU cholecalciferol, (2) once-monthly cholecalciferol', 'Cholecalciferol', 'cholecalciferol supplementation']","['serum hepcidin and parameters related to anaemia and CKD-MBD', 'serum 1,25(OH) 2 D levels', 'serum hepcidin and parameters of anaemia and CKD-MBD', 'serum hepcidin levels', 'serum hepcidin-25 levels', 'erythropoietin resistance', 'serum 1,25(OH) 2 D levels, and hence, reduces active vitamin D drugs']","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585302', 'cui_str': 'Once monthly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C4076240', 'cui_str': 'Chronic kidney disease mineral and bone disorder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",96.0,0.589539,"Both thrice-weekly and once-monthly supplementation effectively increases serum 1,25(OH) 2 D levels, and hence, reduces active vitamin D drugs.","[{'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Obi', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Hamano', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan. hamatea@kid.med.osaka-u.ac.jp.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Inter-Organ Communication Research in Kidney Disease, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shimomura', 'Affiliation': 'Department of Inter-Organ Communication Research in Kidney Disease, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Namba-Hamano', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Mikami', 'Affiliation': 'Department of Internal Medicine, Higashikouri Hospital, Hirakata, Osaka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nishi', 'Affiliation': 'Nishi Clinic, Osaka, Osaka, Japan.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Akebono Clinic, Kumamoto, Kumamoto, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Kamoto', 'Affiliation': 'Futaba Clinic, Osaka, Osaka, Japan.'}, {'ForeName': 'Yasue', 'Initials': 'Y', 'LastName': 'Obi', 'Affiliation': 'Obi Clinic, Osaka, Osaka, Japan.'}, {'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Tomosugi', 'Affiliation': 'Division of Advanced Medicine, Medical Research Institute, Kanazawa Medical University, Kawakita, Ishikawa, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Tsubakihara', 'Affiliation': 'Division of Management in Health Care Sciences, Graduate School of Health Care Sciences, Jikei Institute, Osaka, Osaka, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Isaka', 'Affiliation': 'Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.'}]",Scientific reports,['10.1038/s41598-020-72385-w']
2729,32968171,The effect of transcranial random noise stimulation (tRNS) over bilateral posterior parietal cortex on divergent and convergent thinking.,"Creativity pervades many areas of everyday life and is considered highly relevant in several human living domains. Previous literature suggests that the posterior parietal cortex (PPC) is related to creativity. However, none of previous studies have compared the effect of transcranial random noise stimulation (tRNS) over bilateral PPC on both verbal and visual divergent thinking (DT) and Remote Associates Test (RAT) in the same experimental design. Forty healthy participants were randomly assigned to tRNS (100-500 Hz) over bilateral PPC or sham group, for 15 min and current was set at 1.5 mA. Participants' creativity skills were assessed before and after brain stimulation with the Unusual Uses and the Picture Completion subtests from the Torrance Test of Creative Thinking and the RAT. ANCOVA (baseline scores as covariate) results indicated that tRNS group had significantly higher scores at post-test in RAT and visual originality compared to sham group. Unusual Uses, on the other hand, was not significant. Improvement in RAT suggests the involvement of PPC during via insight solution which may reflect internally directed attention that helps the recombination of remotely associated information. The improvement in visual originality dimension from DT may be due to a higher internally directed attention while reducing externally oriented attention.",2020,The improvement in visual originality dimension from DT may be due to a higher internally directed attention while reducing externally oriented attention.,['Forty healthy participants'],"[""bilateral PPC or sham group, for 15\xa0min and current was set at 1.5\xa0mA. Participants' creativity skills were assessed before and after brain stimulation with the Unusual Uses and the Picture Completion subtests from the Torrance Test of Creative Thinking and the RAT"", 'tRNS', 'transcranial random noise stimulation (tRNS']",['visual originality dimension'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3853037', 'cui_str': 'Posterior Parietal Cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",40.0,0.116756,The improvement in visual originality dimension from DT may be due to a higher internally directed attention while reducing externally oriented attention.,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Peña', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain. javier.pena@deusto.es.'}, {'ForeName': 'Agurne', 'Initials': 'A', 'LastName': 'Sampedro', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain.'}, {'ForeName': 'Naroa', 'Initials': 'N', 'LastName': 'Ibarretxe-Bilbao', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain.'}, {'ForeName': 'Leire', 'Initials': 'L', 'LastName': 'Zubiaurre-Elorza', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain.'}, {'ForeName': 'Aralar', 'Initials': 'A', 'LastName': 'Aizpurua', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Ojeda', 'Affiliation': 'Department of Methods and Experimental Psychology, Faculty of Psychology and Education, University of Deusto, Avda. Universidades 24, 48007, Bilbao, , Basque Country, Spain.'}]",Scientific reports,['10.1038/s41598-020-72532-3']
2730,32968274,Local exposure to inequality raises support of people of low wealth for taxing the wealthy.,"Psychological research shows that social comparison of individuals with peers or others shapes attitude formation 1,2 . Opportunities for such comparisons have increased with global inequality 3,4 ; everyday experiences can make economic disparities more salient through signals of social class 5,6 . Here we show that, among individuals with a lower socioeconomic status, such local exposure to inequality drives support for the redistribution of wealth. We designed a placebo-controlled field experiment conducted in South African neighbourhoods in which individuals with a low socioeconomic status encountered real-world reminders of inequality through the randomized presence of a high-status car. Pedestrians were asked to sign a petition to increase taxes on wealthy individuals to help with the redistribution of wealth. We found an increase of eleven percentage points in the probability of signing the petition in the presence of inequality, when taking into account the experimental placebo effect. The placebo effect suppresses the probability that an individual signs the petition in general, which is consistent with evidence that upward social comparison reduces political efficacy 4 . Measures of economic inequality were constructed at the neighbourhood level and connected to a survey of individuals with a low socioeconomic status. We found that local exposure to inequality was positively associated with support for a tax on wealthy individuals to address economic disparities. Inequality seems to affect preferences for the redistribution of wealth through local exposure. However, our results indicate that inequality may also suppress participation; the political implications of our findings at regional or country-wide scales therefore remain uncertain.",2020,We found that local exposure to inequality was positively associated with support for a tax on wealthy individuals to address economic disparities.,"['South African neighbourhoods in which individuals with a low socioeconomic status encountered real-world reminders of inequality through the randomized presence of a high-status car', 'individuals with peers or others shapes attitude formation 1,2 ']",['placebo'],[],"[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0242503', 'cui_str': 'Unequal'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0306861,We found that local exposure to inequality was positively associated with support for a tax on wealthy individuals to address economic disparities.,"[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Sands', 'Affiliation': 'Political Science, University of California, Merced, CA, USA. msands2@ucmerced.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'de Kadt', 'Affiliation': 'Political Science, University of California, Merced, CA, USA. ddekadt@ucmerced.edu.'}]",Nature,['10.1038/s41586-020-2763-1']
2731,30808774,Effects of Age and Immune Landscape on Outcome in HER2-Positive Breast Cancer in the NCCTG N9831 (Alliance) and NSABP B-31 (NRG) Trials.,"PURPOSE


Young age has been shown to be an independent predictor of poor outcome in breast cancer. In HER2-positive breast cancer, the effects of aging remain largely unknown.
EXPERIMENTAL DESIGN


A total of 4,547 patients were included [3,132 from North Central Cancer Treatment Group (NCCTG) N9831 and 1,415 from National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31]. Pathologic stromal tumor-infiltrating lymphocyte (sTIL) and molecular tumor infiltrating lymphocyte (mTIL) signatures were evaluated.
RESULTS


In NCCTG N9831, comparable benefit of trastuzumab was observed in all patients [age ≤ 40; HR, 0.43; 95% confidence interval (CI), 0.28-0.66;  P  < 0.001; and age > 40; HR, 0.56; 95% CI, 0.45-0.69;  P  < 0.001]. Similar results were observed in NSABP B-31 (age ≤ 40; HR, 0.45; 95% CI, 0.29-0.68;  P  < 0.001; and age > 40; HR, 0.42; 95% CI, 0.33-0.54;  P  < 0.001). Among patients who received chemotherapy alone, younger age was associated with poor outcome in the hormone receptor-positive subset, but not the hormone receptor-negative subset, in both trials. Although there was no association between sTILs and age, a small, but significant increase in mTIL CD45 and some immune subset signatures were observed. Among patients who received chemotherapy alone, patients over 40 years of age with lymphocyte-predominant breast cancer had excellent outcome, with 95% remaining recurrence free at 15 years.
CONCLUSIONS


Among patients treated with trastuzumab, there was no significant difference in outcome related to age. Our study suggests that trastuzumab can negate the poor prognosis associated with young age.",2019,"Among patients treated with trastuzumab, there was no significant difference in outcome related to age.","['patients who received chemotherapy alone, patients over 40 years of age with lymphocyte-predominant breast cancer', '4,547 patients were included [3,132 from North Central Cancer Treatment Group (NCCTG) N9831 and 1,415 from National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31']","['trastuzumab', 'chemotherapy']","['mTIL CD45', 'Pathologic stromal tumor-infiltrating lymphocyte (sTIL) and molecular tumor infiltrating lymphocyte (mTIL) signatures', 'NSABP B-31']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0243402', 'cui_str': 'B 31'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0054961', 'cui_str': 'Lymphocyte antigen CD45'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0879615', 'cui_str': 'Stromal tumor'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0243402', 'cui_str': 'B 31'}]",4547.0,0.0713906,"Among patients treated with trastuzumab, there was no significant difference in outcome related to age.","[{'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Chumsri', 'Affiliation': 'Division of Hematology and Medical Oncology, Mayo Clinic, Jacksonville, Florida. chumsri.saranya@mayo.edu.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Serie', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Pogue-Geile', 'Affiliation': 'National Surgical Adjuvant Breast and Bowel Project (now NRG Oncology), Pittsburgh, Pennsylvania.'}, {'ForeName': 'Aixa E', 'Initials': 'AE', 'LastName': 'Soyano-Muller', 'Affiliation': 'Division of Hematology and Medical Oncology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Mashadi-Hossein', 'Affiliation': 'NanoString Inc., Seattle, Washington.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Warren', 'Affiliation': 'NanoString Inc., Seattle, Washington.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'Division of Hematology and Medical Oncology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Colon-Otero', 'Affiliation': 'Division of Hematology and Medical Oncology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Knutson', 'Affiliation': 'Department of Immunology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Division of Hematology and Medical Oncology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Division of Hematology and Medical Oncology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'E Aubrey', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'Department of Cancer Biology, Mayo Clinic, Jacksonville, Florida.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2206']
2732,15444968,Prolonged anesthesia with serotonin (5 HT); experimental study.,,1956,,[],['serotonin (5 HT'],[],[],"[{'cui': 'C0036751', 'cui_str': 'Serotonin'}]",[],,0.0105341,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'CAHN', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'PIERRE', 'Affiliation': ''}]",Anesthesie et analgesie,[]
2733,18146696,Omentum free transplant in esophageal surgery; experimental study.,,1949,,[],[],[],[],[],[],,0.0145232,,"[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'WESTERMEYER', 'Affiliation': ''}]",Revista medica de Chile,[]
2734,13215352,Trial to treat prostatic hypertrophy with cortisone.,,1954,,[],['cortisone'],[],[],"[{'cui': 'C0010137', 'cui_str': 'Cortisone'}]",[],,0.0352871,,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'SOTIRIOU', 'Affiliation': ''}]",La Presse medicale,[]
2735,13250378,Trial of treatment of bladder bilharziasis with an ascorbohypophosphito-antimonio-tartrate of calcium and potassium.,,1955,,[],['ascorbohypophosphito-antimonio-tartrate of calcium and potassium'],[],[],"[{'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C0039328', 'cui_str': 'Tartrates'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]",[],,0.02953,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'BATAILLARD', 'Affiliation': ''}]",Bulletin de la Societe de pathologie exotique et de ses filiales,[]
2736,32969580,D-dimer enhances risk targeted thromboprophylaxis in ambulatory cancer patients.,"BACKGROUND


Thromboprophylaxis for ambulatory cancer patients is effective, although uncertainties remain on who should be targeted. Using D-dimer values from individuals enrolled to the AVERT trial, we sought to identify and validate a more efficient VTE risk threshold for thromboprophylaxis.
METHODS


The AVERT trial compared thromboprophylaxis with apixaban to placebo among cancer patients with a Khorana Risk Score ≥ 2. The D-dimer measured at randomization was used to calculate an individualized 6-month VTE risk using the validated CATScore. A modified intention to treat analysis was used to assess efficacy (VTE) and safety (major and overall bleeding) in the a) complete cohort, b) ≥8% and <8% 6-month VTE risk thresholds.
RESULTS


574 patients were randomized in the AVERT trial, 466 (81%) with baseline D-dimer were included in the study. 237 subjects received apixaban, 229 received placebo. In the complete cohort, there were 13 (5·5%) VTE events in the apixaban arm compared to 26 (11·4%) events in the placebo arm (aHR-0·49 (0.25-0.95), p<0·05). Number needed to treat (NNT) to prevent one VTE=17. 82(35%) and 72(31%) patients in the apixaban and placebo arms, respectively had a 6-month VTE risk ≥8%. In this sub-group, 7(8·4%) VTE events occurred with apixaban and 19(26·3%) events with placebo (aHR-0·33 (0·14-0·81), p<0.05), NNT=6. Individuals with a VTE risk <8% derived no benefit from apixaban thromboprophylaxis (aHR-0·89 (0·30-2·65), p=0·84). Increased rates of overall bleeding were observed with apixaban in both the complete (aHR-2·11 (1·09-4·09), p<0.05) and ≥8% predicted risk cohorts (aHR-2·87 (0·91-9·13), p=0·07).
CONCLUSIONS


A 6-month VTE risk threshold of ≥8% increases the efficiency of risk targeted thromboprophylaxis in ambulatory cancer patients.
IMPLICATIONS FOR PRACTICE


Ambulatory cancer patients receiving chemotherapy have an increased risk of venous thromboembolism (VTE). A Khorana Risk Score (KRS) ≥2 is currently the suggested threshold for thromboprophylaxis. Using baseline D-dimer values from individuals enrolled to the AVERT trial, this retrospective validation study identifies a 6-month VTE risk of ≥8% as a more efficient threshold for thromboprophylaxis. At this threshold, the number needed to treat to prevent one VTE is 6 compared to 17 in with a KRS≥2. Conversely, individuals with a predicted risk of <8% derive no clinical benefit from thromboprophylaxis. Future prospective studies should validate this threshold for outpatient thromboprophylaxis.",2020,"Individuals with a VTE risk <8% derived no benefit from apixaban thromboprophylaxis (aHR-0·89 (0·30-2·65), p=0·84).","['237 subjects received', 'cancer patients with a Khorana Risk Score ≥\u20092', 'ambulatory cancer patients', '574 patients were randomized in the AVERT trial, 466 (81%) with baseline D-dimer were included in the study', 'Individuals with a VTE risk <8% derived no benefit from apixaban thromboprophylaxis (aHR-0·89 (0·30-2·65), p=0·84', 'Ambulatory cancer patients receiving']","['D-dimer enhances risk targeted thromboprophylaxis', 'apixaban to placebo', 'apixaban and placebo', 'placebo', 'placebo (aHR-0·33', 'apixaban', 'chemotherapy']","['efficacy (VTE) and safety (major and overall bleeding', 'efficiency of risk targeted thromboprophylaxis', 'risk of venous thromboembolism (VTE', 'rates of overall bleeding', 'VTE events']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1312385', 'cui_str': 'AHR protein, human'}]","[{'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1312385', 'cui_str': 'AHR protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",574.0,0.100616,"Individuals with a VTE risk <8% derived no benefit from apixaban thromboprophylaxis (aHR-0·89 (0·30-2·65), p=0·84).","[{'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Division of Hematology and Oncology, University of North Carolina, Chapel Hill, 27514.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Nigel S', 'Initials': 'NS', 'LastName': 'Key', 'Affiliation': 'Division of Hematology and Oncology, University of North Carolina, Chapel Hill, 27514.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Ilich', 'Affiliation': 'Division of Hematology and Oncology, University of North Carolina, Chapel Hill, 27514.'}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Canada.'}]",The oncologist,['10.1002/onco.13540']
2737,32969627,A favorable effect on nutritional status of 12-week tailored texture-modified sous-vide cooking meals in institutionalized elderly women with oropharyngeal dysphagia: an intervention study.,"BACKGROUND


Dysphagic patients are not always able to meet their energy, micro and macronutrients needs for various causes and therefore are at high risk of malnutrition. The aim of the present study is to evaluate the effectiveness on satisfaction of the meal (by a 10-cm visuanalogical scale), food intake (by visual estimation of food waste), nutritional status (anthropometric measures, Mini Nutritional Assessment (MNA), vitamin D, B12, folic acid), functional (handgrip) and blood chemistry metabolic parameters of a tailored texturemodified sous-vide cooking meals (TTMSVC), well balanced in macro and micronutrients, in elderly women suffering from oropharyngeal dysphagia at long-term care facilities.
METHODS


A 12-week intervention study was conducted on female elderly subjects affected by oropharyngeal dysphagia of level 3-5. The treated group received TTMSVC with the consistencies standardized using viscosimeter (5000-10000mP/s). The control group maintained pureed hospital diet.
RESULTS


50 subjects, 25 in treatment group and 25 in control group, with mean ± SD age 89.12±4.18 and Mini Mental State Examination (MMSE) 20.58±1.63 were enrolled. The treatment and control groups were similar at baseline. The changes over time between the two groups showed significant differences for food intake, meal appreciation, Body Mass Index (BMI), calf circumference, arm circumference, MNA, prealbumin, albumin, folic acid, vitamin D, ionized calcium, C-Reactive Protein (CRP), (Tumor Necrosis Factor) TNF alpha, handgrip. Significant positive correlations were observed in the treatment group between the meal appreciation and prealbumin and vitamin D.
CONCLUSIONS


This study demonstrated that elderly dysphagic women at long-term care facilities can eat better and increase nutritional status by eating 12-week tailored appealing TTMSVC.",2020,"The changes over time between the two groups showed significant differences for food intake, meal appreciation, Body Mass Index (BMI), calf circumference, arm circumference, MNA, prealbumin, albumin, folic acid, vitamin D, ionized calcium, C-Reactive Protein (CRP), (Tumor Necrosis Factor)","['Dysphagic patients', 'institutionalized elderly women with oropharyngeal dysphagia', 'elderly dysphagic women at long-term care facilities', 'female elderly subjects affected by oropharyngeal dysphagia of level 3-5', '50 subjects, 25 in treatment group and 25 in control group, with mean ± SD age 89.12±4.18 and Mini Mental State Examination (MMSE) 20.58±1.63 were enrolled', 'elderly women suffering from oropharyngeal dysphagia at long-term care facilities']","['tailored texture-modified sous-vide cooking meals', 'control group maintained pureed hospital diet', 'TTMSVC with the consistencies standardized using viscosimeter']","['food intake, meal appreciation, Body Mass Index (BMI), calf circumference, arm circumference, MNA, prealbumin, albumin, folic acid, vitamin D, ionized calcium, C-Reactive Protein (CRP), (Tumor Necrosis Factor', 'nutritional status (anthropometric measures, Mini Nutritional Assessment (MNA), vitamin D, B12, folic acid), functional (handgrip) and blood chemistry metabolic parameters of a tailored texturemodified sous-vide cooking meals (TTMSVC), well balanced in macro and micronutrients']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0267071', 'cui_str': 'Oropharyngeal dysphagia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}]","[{'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005774', 'cui_str': 'Blood chemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}]",,0.0195563,"The changes over time between the two groups showed significant differences for food intake, meal appreciation, Body Mass Index (BMI), calf circumference, arm circumference, MNA, prealbumin, albumin, folic acid, vitamin D, ionized calcium, C-Reactive Protein (CRP), (Tumor Necrosis Factor)","[{'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Milena A', 'Initials': 'MA', 'LastName': 'Faliva', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona &quot;Istituto Santa Margherita&quot;', University of Pavia, Pavia, Italy.""}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Peroni', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona &quot;Istituto Santa Margherita&quot;', University of Pavia, Pavia, Italy - gabriella.peroni01@universitadipavia.it.""}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': 'Department of Biology, College of Science, University of Bahrain, Sakhir Campus, Sakhir, Bahrain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Gasparri', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona &quot;Istituto Santa Margherita&quot;', University of Pavia, Pavia, Italy.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Fazia', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Bernardinelli', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Infantino', 'Affiliation': 'Department of Public Health, Experimental and Forensic Medicine, Unit of Human and Clinical Nutrition, University of Pavia, Pavia, Italy.'}]",Minerva endocrinologica,['10.23736/S0391-1977.20.03232-0']
2738,32969628,A new breakfast brioche containing bergamot fiber prevents insulin and glucose increase in healthy volunteers: a pilot study.,"BACKGROUND


Despite the abundance of studies on the beneficial effects of a fiber rich diet as well as polyphenols deriving from Citrus fruits on postprandial serum glucose and insulin, clinical evidences on their synergic effects on healthy subjects have never been published. We aimed to investigate the feasibility of a new dietary approach in controlling glucose and insulin response at breakfast time by testing a brioche enriched with wheat bran and bergamot fiber.
METHODS


We enrolled 11 healthy volunteers in a cross-over study. Participants consumed a classic brioche at breakfast and our functional brioche, containing wheat bran and bergamot fiber, on another day. Vital functions, biochemical parameters (including glucose and insulin), anthropometric measurements as well as resting energy expenditure and fat oxidation were evaluated before and after the intake of both meals.
RESULTS


The mean age was ~25 years. The mean BMI was 23.5 kg/m2. The consumption of the functional brioche reduced the glucose CMAX(0-120 min) by ~6% and prevented the insulin increase over time by 30%, finally demonstrating insulin CMAX(0-120 min) and iAUC(0-120 min) values significantly lower compared to classic brioche (respectively p-value=0.04 and 0.03). The stepwise multivariable analysis confirmed the association between the consumption of the functional brioche containing bran and bergamot fiber and glucose CMAX(0-120 min) (B=-0.45; p=0.034), and insulin iAUC(0-120 min) (B=-764 p=0.036).
CONCLUSIONS


The association of wheat bran and bergamot fiber significantly influences glucose metabolism and may exert insulin-like effects on healthy volunteers. If confirmed, Bergabrioche would be a useful tool in preventing diabetes and controlling the glycometabolic status of Type 2 diabetic patients.",2020,"Vital functions, biochemical parameters (including glucose and insulin), anthropometric measurements as well as resting energy expenditure and fat oxidation were evaluated before and after the intake of both meals.
","['11 healthy volunteers in a cross-over study', 'Type 2 diabetic patients', 'healthy volunteers', 'healthy subjects']",['wheat bran and bergamot fiber'],"['mean BMI', 'Vital functions, biochemical parameters (including glucose and insulin), anthropometric measurements as well as resting energy expenditure and fat oxidation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0043138', 'cui_str': 'Wheat bran'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",11.0,0.0203507,"Vital functions, biochemical parameters (including glucose and insulin), anthropometric measurements as well as resting energy expenditure and fat oxidation were evaluated before and after the intake of both meals.
","[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Mare', 'Affiliation': 'Department of Medical and Surgical Sciences, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Mazza', 'Affiliation': 'Department of Medical and Surgical Sciences, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Yvelise', 'Initials': 'Y', 'LastName': 'Ferro', 'Affiliation': 'Department of Health Sciences, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Gliozzi', 'Affiliation': 'Department of Health Sciences, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Nucera', 'Affiliation': 'Department of Health Sciences, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Paone', 'Affiliation': 'Department of Health Sciences, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Ilenia', 'Initials': 'I', 'LastName': 'Aversa', 'Affiliation': 'Department of Clinical and Experimental Medicine, Nutrition Unit, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Pujia', 'Affiliation': 'Department of Medical and Surgical Sciences, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Marafioti', 'Affiliation': 'Department of Medical and Surgical Sciences, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Musolino', 'Affiliation': 'Department of Health Sciences, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mollace', 'Affiliation': 'Department of Health Sciences, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Montalcini', 'Affiliation': 'Department of Clinical and Experimental Medicine, Nutrition Unit, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy - tmontalcini@unicz.it.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Pujia', 'Affiliation': 'Department of Medical and Surgical Sciences, Campus Universitario di Germaneto, University &quot;Magna Græcia&quot; of Catanzaro, Catanzaro, Italy.'}]",Minerva endocrinologica,['10.23736/S0391-1977.20.03243-5']
2739,32969686,Mindfulness interventions improve momentary and trait measures of attentional control: Evidence from a randomized controlled trial.,"Mindfulness interventions have been shown to improve several subcomponents of attention; however, the psychological mechanisms driving these improvements are unknown. Mindfulness interventions train individuals to monitor present moment experiences while adopting an attitude of acceptance toward these experiences. We conducted a theoretically driven randomized controlled trial to test the putative mechanisms of mindfulness training that drive improvements in attentional control. Participants were randomly assigned to 1 of 3 conditions: (a) monitor and accept (MA) training, a standard 8-week mindfulness-based stress reduction (MBSR) intervention that included cultivation of both monitoring and acceptance skills; (b) monitor only (MO) training, a well-matched modified 8-week MBSR-adapted intervention that focused on monitoring skills only; or (c) no treatment (NT) control. Momentary attentional control was measured via ecological momentary assessment for 3 days at baseline and postintervention. Trait attentional control was assessed at baseline and postintervention using traditional self-report. Participants also completed a dichotic listening task to assess sustained attention at baseline and postintervention. We found that MA and MO participants improved in momentary and trait attentional control (but not attention task performance) relative to NT participants. Analyses of indirect effects were consistent with the possibility that increased momentary attentional control partially accounts for MA/MO intervention-related increases in trait attentional control. This randomized controlled trial provides one of the first experimental tests of the mechanisms of mindfulness interventions that drive improvements in attention outcomes. These findings support the notion that present-focused monitoring skills training drives mindfulness intervention-related improvements in momentary attentional control, which in turn fosters greater trait attentional control. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,We found that MA and MO participants improved in momentary and trait attentional control (but not attention task performance) relative to NT participants.,[],"['mindfulness training', 'dichotic listening task', 'Mindfulness interventions', 'monitor and accept (MA) training, a standard 8-week mindfulness-based stress reduction (MBSR) intervention that included cultivation of both monitoring and acceptance skills; (b) monitor only (MO) training, a well-matched modified 8-week MBSR-adapted intervention that focused on monitoring skills only; or (c) no treatment (NT) control', 'MA']","['Trait attentional control', 'attentional control', 'momentary and trait attentional control', 'trait attentional control', 'Momentary attentional control']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0274135,We found that MA and MO participants improved in momentary and trait attentional control (but not attention task performance) relative to NT participants.,"[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Chin', 'Affiliation': 'Department of Psychology, Carnegie Mellon University.'}, {'ForeName': 'Emily K', 'Initials': 'EK', 'LastName': 'Lindsay', 'Affiliation': 'Department of Psychology, University of Pittsburgh.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Greco', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh.'}, {'ForeName': 'Kirk Warren', 'Initials': 'KW', 'LastName': 'Brown', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University.'}, {'ForeName': 'Aidan G C', 'Initials': 'AGC', 'LastName': 'Wright', 'Affiliation': 'Department of Psychology, University of Pittsburgh.'}, {'ForeName': 'J David', 'Initials': 'JD', 'LastName': 'Creswell', 'Affiliation': 'Department of Psychology, Carnegie Mellon University.'}]",Journal of experimental psychology. General,['10.1037/xge0000969']
2740,32969758,"A Phase 2, Double-Blind, Randomized, Dose-Ranging Trial Of  Reldesemtiv  In Patients With ALS.","OBJECTIVE


To evaluate safety, dose response, and preliminary efficacy of  reldesemtiv  over 12 weeks in patients with amyotrophic lateral sclerosis (ALS).  Methods:  Patients (≤2 years since diagnosis) with slow upright vital capacity (SVC) of ≥60% were randomized 1:1:1:1 to  reldesemtiv  150, 300, or 450 mg twice daily (bid) or placebo; active treatment was 12 weeks with 4-week follow-up. Primary endpoint was change in percent predicted SVC at 12 weeks; secondary measures included ALS Functional Rating Scale-Revised (ALSFRS-R) and muscle strength mega-score.  Results:  Patients ( N  = 458) were enrolled; 85% completed 12-week treatment. The primary analysis failed to reach statistical significance ( p  = 0.11); secondary endpoints showed no statistically significant effects (ALSFRS-R,  p  = 0.09; muscle strength mega-score,  p  = 0.31). Post hoc analyses pooling all active  reldesemtiv -treated patients compared against placebo showed trends toward benefit in all endpoints (progression rate for SVC, ALSFRS-R, and muscle strength mega-score (nominal p values of 0.10, 0.01 and 0.20 respectively)).  Reldesemtiv  was well tolerated, with nausea and fatigue being the most common side effects. A dose-dependent decrease in estimated glomerular filtration rate was noted, and transaminase elevations were seen in approximately 5% of patients. Both hepatic and renal abnormalities trended toward resolution after study drug discontinuation.  Conclusions:  Although the primary efficacy analysis did not demonstrate statistical significance, there were trends favoring  reldesemtiv  for all three endpoints, with effect sizes generally regarded as clinically important. Tolerability was good; modest hepatic and renal abnormalities were reversible. The impact of  reldesemtiv  on patients with ALS should be assessed in a pivotal Phase 3 trial. (ClinicalTrials.gov Identifier: NCT03160898).",2020,"patients compared against placebo showed trends toward benefit in all endpoints (progression rate for SVC, ALSFRS-R, and muscle strength mega-score (nominal p values of 0.10, 0.01 and 0.20 respectively)).  ","['Patients (≤2 years since diagnosis) with slow upright vital capacity (SVC) of ≥60', 'Patients With ALS', 'patients with ALS', 'patients with amyotrophic lateral sclerosis (ALS', 'Patients ( N \u2009=\u2009458) were enrolled; 85% completed 12-week treatment']",['placebo'],"['ALS Functional Rating Scale-Revised (ALSFRS-R) and muscle strength mega-score', 'hepatic and renal abnormalities', 'endpoints (progression rate for SVC, ALSFRS-R, and muscle strength mega-score', 'Tolerability', 'transaminase elevations', 'estimated glomerular filtration rate', 'tolerated, with nausea and fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",458.0,0.229379,"patients compared against placebo showed trends toward benefit in all endpoints (progression rate for SVC, ALSFRS-R, and muscle strength mega-score (nominal p values of 0.10, 0.01 and 0.20 respectively)).  ","[{'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Jinsy A', 'Initials': 'JA', 'LastName': 'Andrews', 'Affiliation': 'The Eleanor and Lou Gehrig ALS Center, The Neurological Institute, New York, NY, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Genge', 'Affiliation': 'Montreal Neurological Institute, Montreal, QC, Canada.'}, {'ForeName': 'Carlayne', 'Initials': 'C', 'LastName': 'Jackson', 'Affiliation': 'University of Texas Health Science Center, San Antonio, TX, USA.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Lechtzin', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Miller', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Bettina M', 'Initials': 'BM', 'LastName': 'Cockroft', 'Affiliation': 'Cytokinetics, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Cytokinetics, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Cytokinetics, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wolff', 'Affiliation': 'Cytokinetics, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Fady I', 'Initials': 'FI', 'LastName': 'Malik', 'Affiliation': 'Cytokinetics, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Bodkin', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Brooks', 'Affiliation': 'Atrium Health Neurosciences Institute-Carolinas Neuromuscular/ALS MDA Care Center, Charlotte, NC, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Caress', 'Affiliation': 'Wake Forest Health Sciences, Winston-Salem, NC, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Dionne', 'Affiliation': 'CHU de Québec, Université Laval, Quebec, Canada.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Fee', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Goutman', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': 'The ALS & Neuromuscular Center, UCI Health, Orange, CA, USA.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'Hardiman', 'Affiliation': 'Trinity College, Beaumont Hospital, Dublin, Ireland.'}, {'ForeName': 'Ghazala', 'Initials': 'G', 'LastName': 'Hayat', 'Affiliation': 'St. Louis University, St. Louis, MO, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Heiman-Patterson', 'Affiliation': 'Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Daragh', 'Initials': 'D', 'LastName': 'Heitzman', 'Affiliation': 'Texas Neurology, Dallas, TX, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Henderson', 'Affiliation': ""Royal Brisbane and Women's Hospital, Herston, Australia.""}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Johnston', 'Affiliation': 'University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Kiernan', 'Affiliation': 'Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kolb', 'Affiliation': 'Wexner Medical Center, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Korngut', 'Affiliation': 'University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': ""St. Joseph's Hospital and Medical Center, Neurological Institute, AZ, USA Barrow Phoenix.""}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Matte', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Jesus S', 'Initials': 'JS', 'LastName': 'Mora', 'Affiliation': 'Hospital San Rafael, Madrid, Germany.'}, {'ForeName': 'Merrilee', 'Initials': 'M', 'LastName': 'Needham', 'Affiliation': 'Perron Institute, Department of Neurology, Fiona Stanley Hospital, The University of Notre Dame Australia, Murdoch University, Perth, Australia.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Oskarsson', 'Affiliation': 'Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Pattee', 'Affiliation': 'Neurology Associates, Lincoln, NE, USA.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Pioro', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pulley', 'Affiliation': 'University of Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Quan', 'Affiliation': 'University of Colorado Denver, Aurora, CO, USA.'}, {'ForeName': 'Kourosh', 'Initials': 'K', 'LastName': 'Rezania', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Schellenberg', 'Affiliation': 'University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schultz', 'Affiliation': 'Flinders Medical Centre, Bedford Park, Australia.'}, {'ForeName': 'Christen', 'Initials': 'C', 'LastName': 'Shoesmith', 'Affiliation': 'London Health Sciences Centre, London, ON, Canada.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Simmons', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Statland', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Shumaila', 'Initials': 'S', 'LastName': 'Sultan', 'Affiliation': 'West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Swenson', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Leonard H Van Den', 'Initials': 'LHVD', 'LastName': 'Berg', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Tuan', 'Initials': 'T', 'LastName': 'Vu', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Vucic', 'Affiliation': 'Westmead Hospital, Sydney, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Whyte-Rayson', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wymer', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Lorne', 'Initials': 'L', 'LastName': 'Zinman', 'Affiliation': 'ALS/Neuromuscular Clinic Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Rudnicki', 'Affiliation': 'Cytokinetics, Inc, South San Francisco, CA, USA.'}]",Amyotrophic lateral sclerosis & frontotemporal degeneration,['10.1080/21678421.2020.1822410']
2741,32969781,Amelioration of Sleep Disordered Breathing with Supplemental Oxygen in Older Adults.,"Elderly adults demonstrate increased propensity for breathing instability during sleep compared with younger adults and this may contribute to increased prevalence of sleep disordered breathing (SDB) in this population. Hence, in older adults with SDB, we examined whether addition of supplemental oxygen (O 2 ) will stabilize breathing during sleep and alleviate SDB. We hypothesized that exposure to supplemental O 2  during non-rapid eye movement (NREM) sleep will stabilize breathing and alleviate SDB by reducing ventilatory chemoresponsiveness and widening the carbon dioxide (CO 2 ) reserve. We studied 10 older adults with mild-moderate SDB who were randomized to undergo noninvasive bilevel mechanical with exposure to room air or supplemental O 2  (Oxy) to determine the CO 2  reserve, apneic threshold(AT) and controller and plant gains. Supplemental O 2  was introduced during sleep to achieve a steady state O 2  saturation ≥95% and fraction of inspired O 2  at 40-50%. The CO 2  reserve increased significantly during Oxy vs. room air (-4.2 ± 0.5 mmHg vs -3.2 ± 0.5 mmHg, p=0.03). Compared with room air, Oxy was associated with a significant decline in the controller gain (1.9 ± 0.4 L/min/mmHg vs. 2.5 ± 0.5 L/min/mmHg, p=0.04), with reductions in the apnea hypopnea index (11.8 ± 2.0/hour vs. 24.4 ± 5.6/hour, p=0.006) and central-apnea-hypopnea index (1.7 ± 0.6/hour vs. 6.9 ± 3.9/hour, p=0.03). The AT and plant gain were unchanged. Thus, a reduced slope of CO 2  response resulted in an increased CO 2  reserve. In conclusion, supplemental O 2  reduced SDB in older adults during NREM sleep via reduction in chemoresponsiveness and central respiratory events.",2020,"The CO 2  reserve increased significantly during Oxy vs. room air (-4.2 ± 0.5 mmHg vs -3.2 ± 0.5 mmHg, p=0.03).","['older adults', 'older adults with SDB', 'Older Adults', '10 older adults with mild-moderate SDB', 'Elderly adults']","['supplemental O 2  reduced SDB', 'noninvasive bilevel mechanical with exposure to room air or supplemental O 2  (Oxy) to determine the CO 2  reserve, apneic threshold(AT) and controller and plant gains', 'Sleep Disordered Breathing with Supplemental Oxygen', 'supplemental O 2  during non-rapid eye movement (NREM) sleep will stabilize breathing and alleviate SDB']","['controller gain', 'AT and plant gain', 'breathing instability', 'apnea hypopnea index', 'central-apnea-hypopnea index', 'CO 2  reserve']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",10.0,0.0306001,"The CO 2  reserve increased significantly during Oxy vs. room air (-4.2 ± 0.5 mmHg vs -3.2 ± 0.5 mmHg, p=0.03).","[{'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Rastogi', 'Affiliation': 'Medical Service (11M), Sleep Medicine Section, John D. Dingell VA Medical Center, United States.'}, {'ForeName': 'M Safwan', 'Initials': 'MS', 'LastName': 'Badr', 'Affiliation': 'Department of Internal Medicine, Wayne State University School of Medicine, United States.'}, {'ForeName': 'Abdullahi', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Department of Medicine, Wayne State University School of Medicine, United States.'}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Chowdhuri', 'Affiliation': 'Medical Service (11M), Sleep Medicine Section, John D. Dingell VA Medical Center, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00253.2020']
2742,32969828,Development and Evaluation of an Accelerometer-Based Protocol for Measuring Physical Activity Levels in Cancer Survivors: Development and Usability Study.,"BACKGROUND


The collection of self-reported physical activity using validated questionnaires has known bias and measurement error.
OBJECTIVE


Accelerometry, an objective measure of daily activity, increases the rigor and accuracy of physical activity measurements. Here, we describe the methodology and related protocols for accelerometry data collection and quality assurance using the Actigraph GT9X accelerometer data collection in a convenience sample of ovarian cancer survivors enrolled in GOG/NRG 0225, a 24-month randomized controlled trial of diet and physical activity intervention versus attention control.
METHODS


From July 2015 to December 2019, accelerometers were mailed on 1337 separate occasions to 580 study participants to wear at 4 time points (baseline, 6, 12, and 24 months) for 7 consecutive days. Study staff contacted participants via telephone to confirm their availability to wear the accelerometers and reviewed instructions and procedures regarding the return of the accelerometers and assisted with any technology concerns.
RESULTS


We evaluated factors associated with wear compliance, including activity tracking, use of a mobile app, and demographic characteristics with chi-square tests and logistic regression. Compliant data, defined as ≥4 consecutive days with ≥10 hours daily wear time, exceeded 90% at all study time points. Activity tracking, but no other characteristics, was significantly associated with compliant data at all time points (P<.001). This implementation of data collection through accelerometry provided highly compliant and usable activity data in women who recently completed treatment for ovarian cancer.
CONCLUSIONS


The high compliance and data quality associated with this protocol suggest that it could be disseminated to support researchers who seek to collect robust objective activity data in cancer survivors residing in a wide geographic area.",2020,"Activity tracking, but no other characteristics, was significantly associated with compliant data at all time points (P<.001).","['Cancer Survivors', 'From July 2015 to December 2019, accelerometers were mailed on 1337 separate occasions to 580 study participants to wear at 4 time points (baseline, 6, 12, and 24 months) for 7 consecutive days', 'women who recently completed treatment for ovarian cancer', 'convenience sample of ovarian cancer survivors enrolled in GOG/NRG 0225']","['Accelerometer-Based Protocol', 'Actigraph GT9X accelerometer data collection', 'diet and physical activity intervention versus attention control']","['rigor and accuracy of physical activity measurements', 'Activity tracking', 'wear compliance, including activity tracking, use of a mobile app, and demographic characteristics']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",580.0,0.0624126,"Activity tracking, but no other characteristics, was significantly associated with compliant data at all time points (P<.001).","[{'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Crane', 'Affiliation': 'Department of Biobehavioral Health Sciences, College of Nursing, University of Arizona, Tucson, AZ, United States.'}, {'ForeName': 'Meghan B', 'Initials': 'MB', 'LastName': 'Skiba', 'Affiliation': 'Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'Department of Biostatistics, Roswell Park Cancer Institute, Buffalo, NY, United States.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Garcia', 'Affiliation': 'Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Thomson', 'Affiliation': 'Department of Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, United States.'}]",JMIR mHealth and uHealth,['10.2196/18491']
2743,32969832,Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial.,"BACKGROUND


Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative-enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain.
OBJECTIVE


Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain.
METHODS


This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative-enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge.
RESULTS


A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms.
CONCLUSIONS


This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19496.",2020,"Video narrative-enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain.
","['Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain', 'mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96', '1302 patients were enrolled over 24 months', 'patients who present to emergency departments with back pain and kidney stone pain']","['risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative-enhanced probabilistic ORT', 'probabilistic and narrative-enhanced opioid risk communication']","['Demographics and ORT scores', 'back pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004600', 'cui_str': 'Back'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",1302.0,0.114005,"Video narrative-enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain.
","[{'ForeName': 'Zachary F', 'Initials': 'ZF', 'LastName': 'Meisel', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Erica B', 'Initials': 'EB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Abby R', 'Initials': 'AR', 'LastName': 'Dolan', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Esha', 'Initials': 'E', 'LastName': 'Bansal', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Karin V', 'Initials': 'KV', 'LastName': 'Rhodes', 'Affiliation': 'Department of Population Health Management, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY, United States.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Hess', 'Affiliation': 'Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Carolyn C', 'Initials': 'CC', 'LastName': 'Cannuscio', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Marilyn M', 'Initials': 'MM', 'LastName': 'Schapira', 'Affiliation': 'Department of General and Internal Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Jeanmarie', 'Initials': 'J', 'LastName': 'Perrone', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Rodgers', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Zyla', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Bell', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'McCollum', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Shofer', 'Affiliation': 'Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.'}]",JMIR research protocols,['10.2196/19496']
2744,32970172,Effects of β-Lactam Antibiotics on Gut Microbiota Colonization and Metabolites in Late Preterm Infants.,"We usually refer to the critical period for intestinal flora establishment as infancy because the infant gut microbiota is characterized by low diversity and poor stability compared with that of adults. Moreover, it is also vulnerable to interference from a variety of factors. As β-lactam antibiotics are typically used in newborn infants with infectious diseases, we used 16S rDNA sequencing and LC-MS metabolomics to analyze fecal microbes and metabolites in 16 late preterm infants with or without β-lactam antibiotic treatment. The subjects were assigned to two groups: one not treated with antibiotics and another receiving β-lactam antibiotic treatment for less than seven days. Significant changes in fecal microbes and metabolites were observed in the late preterm infants treated with antibiotics, including a reduction in the diversity of the gut microbiota overall and some beneficial bacteria such as Bacteroides, whereas some opportunistic pathogenic bacteria such as Enterococcus showed an overgrowth trend. In addition, significant changes in some crucial metabolites were observed, such as amino acids and bile acids. These findings show that treatment with β-lactam antibiotics might affect the intestinal flora and its metabolites in late preterm infants in a short time period.",2020,"Significant changes in fecal microbes and metabolites were observed in the late preterm infants treated with antibiotics, including a reduction in the diversity of the gut microbiota overall and some beneficial bacteria such as Bacteroides, whereas some opportunistic pathogenic bacteria such as Enterococcus showed an overgrowth trend.","['newborn infants with infectious diseases', '16 late preterm infants with or without β-lactam antibiotic treatment', 'Late Preterm Infants']","['β-lactam antibiotics', 'antibiotics and another receiving β-lactam antibiotic treatment', 'β-Lactam Antibiotics']","['intestinal flora and its metabolites', 'amino acids and bile acids', 'Gut Microbiota Colonization and Metabolites', 'fecal microbes and metabolites']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C3898619', 'cui_str': 'Late preterm infant'}, {'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",16.0,0.0168328,"Significant changes in fecal microbes and metabolites were observed in the late preterm infants treated with antibiotics, including a reduction in the diversity of the gut microbiota overall and some beneficial bacteria such as Bacteroides, whereas some opportunistic pathogenic bacteria such as Enterococcus showed an overgrowth trend.","[{'ForeName': 'Siliang', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Department of Pediatrics, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Qingmei', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Bingmei', 'Initials': 'B', 'LastName': 'Wei', 'Affiliation': 'Department of Pediatrics, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.'}, {'ForeName': 'Yujun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China. chenyujun1006@163.com.'}]",Current microbiology,['10.1007/s00284-020-02198-7']
2745,32970234,The impact of Hayward green kiwifruit on dietary protein digestion and protein metabolism.,"PURPOSE


The purpose of the study was to determine if an actinidin protease aids gastric digestion and the protein anabolic response to dietary protein.
METHODS


Hayward green kiwifruit (containing an actinidin protease) and Hort 16A gold kiwifruit (devoid of actinidin protease) were given in conjunction with a beef meal to healthy older subjects. Twelve healthy older males (N = 6) and females (N = 6) were studied with a randomized, double-blinded, crossover design to assess muscle and whole-body protein metabolism before and after ingestion of kiwifruit and 100 g of ground beef. Subjects consumed 2 of each variety of kiwifruit daily for 14 d prior to each metabolic study, and again during each study with beef intake.
RESULTS


Hayward green kiwifruit consumption with beef resulted in a more rapid increase in peripheral plasma essential amino acid concentrations. There were significant time by kiwifruit intake interactions for plasma concentrations of EAAs, branched chain amino acids (BCAAs), and leucine (P < 0.01). However, there was no difference in the total amount of EAAs absorbed. As a result, there were no differences between kiwifruit in any of the measured parameters of protein kinetics.
CONCLUSION


Consumption of Hayward green kiwifruit, with a beef meal facilitates protein digestion and absorption of the constituent amino acids as compared to Hort 16A gold kiwifruit.
CLINICAL TRIAL


NCT04356573, April 21, 2020 ""retrospectively registered"".",2020,"RESULTS


Hayward green kiwifruit consumption with beef resulted in a more rapid increase in peripheral plasma essential amino acid concentrations.","['healthy older subjects', 'Twelve healthy older males (N\u2009=\u20096) and females (N\u2009=\u20096']","['Hayward green kiwifruit (containing an actinidin protease) and Hort 16A gold kiwifruit (devoid of actinidin protease', 'Hayward green kiwifruit']","['peripheral plasma essential amino acid concentrations', 'plasma concentrations of EAAs, branched chain amino acids (BCAAs), and leucine']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0971874', 'cui_str': 'Actinidia deliciosa'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0050639', 'cui_str': 'Actinidin'}, {'cui': 'C0030940', 'cui_str': 'Peptide Hydrolases'}, {'cui': 'C0018026', 'cui_str': 'Gold'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}]",12.0,0.0721214,"RESULTS


Hayward green kiwifruit consumption with beef resulted in a more rapid increase in peripheral plasma essential amino acid concentrations.","[{'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Church', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Carlene', 'Initials': 'C', 'LastName': 'Starck', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Schutzler', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Gohar', 'Initials': 'G', 'LastName': 'Azhar', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Il-Young', 'Initials': 'IY', 'LastName': 'Kim', 'Affiliation': 'Department of Molecular Medicine, Lee Gil Ya Cancer and Diabetes Institute, College of Medicine, Gachon University, Incheon, Republic of Korea.'}, {'ForeName': 'Arny A', 'Initials': 'AA', 'LastName': 'Ferrando', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Moughan', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA. rwolfe2@uams.edu.'}]",European journal of nutrition,['10.1007/s00394-020-02363-5']
2746,32970235,Postprandial glycemic response differed by early life nutritional exposure in a longitudinal cohort: a single- and multi-biomarker approach.,"PURPOSE


Populations malnourished in early life are at increased risk for cardiometabolic diseases. We assessed if improved nutrition predicts cardiometabolic function, as assessed by postprandial biomarker responses.
METHODS


Participants had been randomized at the village level to receive one of two nutritional supplements as children. At mean age 44 y (range 37-53 years), we obtained plasma samples before and 2 h after a mixed-component meal challenge. We assayed biomarkers including lipids, glycemic measurements, and inflammatory cytokines. We compared postprandial biomarker responses among those who received the improved nutrition intervention from conception through to their second birthday (the first 1000 days) to those with other exposure status, including those who received the improved nutrition intervention at other ages, and those who received the less nutritious supplement.
RESULTS


Among 1027 participants (59.4% female), 22.9% were exposed to improved nutrition in the first 1000 days. Insulin increased the most in response to the meal challenge (over twofold), and non-esterified fatty acids decreased the most (by half). Glucose increased postprandial by 11.4% in the exposed group, compared with 15.7% in the other exposure group (p < 0.05), which remained significant after adjusting for confounders (- 4.7%; 95% confidence interval: - 9.3%, - 0.01%). Responses to the prandial challenges for the other biomarkers did not differ by intervention group (all p > 0.05).
CONCLUSION


Early life exposure to improved nutrition was associated with a more favorable postprandial glucose response in this population. We did not observe a difference in overall cardiometabolic responses between the exposure groups.",2020,"Glucose increased postprandial by 11.4% in the exposed group, compared with 15.7% in the other exposure group (p < 0.05), which remained significant after adjusting for confounders (- 4.7%; 95% confidence interval: - 9.3%, - 0.01%).","['1027 participants (59.4% female', 'Participants had been randomized at the village level to receive one of two nutritional supplements as children', 'At mean age 44 y (range 37-53 years']","['improved nutrition intervention at other ages, and those who received the less nutritious supplement']","['postprandial biomarker responses', 'lipids, glycemic measurements, and inflammatory cytokines', 'overall cardiometabolic responses', 'Postprandial glycemic response', 'Glucose increased postprandial', 'favorable postprandial glucose response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",1027.0,0.0358242,"Glucose increased postprandial by 11.4% in the exposed group, compared with 15.7% in the other exposure group (p < 0.05), which remained significant after adjusting for confounders (- 4.7%; 95% confidence interval: - 9.3%, - 0.01%).","[{'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Ngoc-Anh', 'Initials': 'NA', 'LastName': 'Le', 'Affiliation': 'Biomarker Core Laboratory, Foundation for Atlanta Veterans Education and Research (FAVER), Atlanta Veterans Affairs Health Care System (AVAHCS), Atlanta, GA, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramìrez-Zea', 'Affiliation': 'INCAP Research Center for the Prevention of Chronic Diseases (CIIPEC), Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Room 7007, 1518 Clifton Rd NE, Atlanta, GA, 30322, USA.'}, {'ForeName': 'K M Venkat', 'Initials': 'KMV', 'LastName': 'Narayan', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Room 7007, 1518 Clifton Rd NE, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Room 7007, 1518 Clifton Rd NE, Atlanta, GA, 30322, USA. aryeh.stein@emory.edu.'}]",European journal of nutrition,['10.1007/s00394-020-02389-9']
2747,32970236,Healthcare expenditure and its predictors in a cohort of Australians living with sciatica.,"PURPOSE


To estimate the healthcare resource utilisation of an Australian cohort of people with sciatica and explore individual-level factors associated with expenditure.
METHODS


Healthcare utilisation (services and medication) data from a randomised, double-blind, placebo-controlled trial of pregabalin in patients with sciatica (n = 185) were analysed to estimate healthcare expenditure of participants over 12 months. Associations between key baseline socio-economic, pain and quality of life characteristics and healthcare expenditure were examined using generalised linear imputation models.
RESULTS


On average, participants accessed AUD$1,134 of healthcare over the year, predominantly made up of $114 of medication and $914 of health services, which included $418 of physiotherapy services. Participants randomised to receive pregabalin incurred higher expenditure ($1,263 compared to $1,001 for placebo), which was largely driven by pregabalin ($158) and greater health services ($107). Healthcare expenditure was significantly higher for participants prescribed pregabalin, earning greater than $1,700 per week ($88,400 per year) and reporting poorer quality of life (physical and mental).
CONCLUSION


Our results suggest inefficiency in the use of healthcare resources due to increased healthcare resource utilisation in people with sciatica treated with pregabalin, compared to placebo. Costs of treating sciatica varied based on individual quality of life and socio-economic characteristics.",2020,"Healthcare expenditure was significantly higher for participants prescribed pregabalin, earning greater than $1,700 per week ($88,400 per year) and reporting poorer quality of life (physical and mental).
","['Australian cohort of people with sciatica and explore individual-level factors associated with expenditure', 'people with sciatica treated with', 'cohort of Australians living with sciatica', 'patients with sciatica (n\u2009=\u2009185']","['pregabalin', 'placebo']","['poorer quality of life (physical and mental', 'healthcare resource utilisation', 'Healthcare expenditure', 'baseline socio-economic, pain and quality of life characteristics and healthcare expenditure']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.48603,"Healthcare expenditure was significantly higher for participants prescribed pregabalin, earning greater than $1,700 per week ($88,400 per year) and reporting poorer quality of life (physical and mental).
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Chye', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Level 5, 1 King Street, Newtown, Sydney, 2041, Australia. achye@georgeinstitute.org.au.'}, {'ForeName': 'Chung-Wei Christine', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'The Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hancock', 'Affiliation': 'Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Harris', 'Affiliation': 'South Western Sydney Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'The Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'The Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McLachlan', 'Affiliation': 'Sydney Pharmacy School, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mathieson', 'Affiliation': 'The Institute for Musculoskeletal Health, Sydney, Australia.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Koes', 'Affiliation': 'Department of General Practice, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Day', 'Affiliation': ""St Vincent's Clinical School, Faculty of Medicine, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Level 5, 1 King Street, Newtown, Sydney, 2041, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Level 5, 1 King Street, Newtown, Sydney, 2041, Australia.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Angell', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Level 5, 1 King Street, Newtown, Sydney, 2041, Australia.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06605-2']
2748,32968676,"Determine the BMI levels, self-concept and healthy life behaviours of children during a school based obesity training programme.","Sedentary lifestyles and unhealthy nutrition, in particular, cause childhood obesity. The purpose of this semi-experimental research is to determine the changes in body mass index, self-concept, and healthy lifestyle behaviours of children during a training programme to prevent obesity. Children 9 and 15 years old were included from two public secondary schools. A total of 1609 students completed the study in the intervention and control groups (1022 vs 587, respectively). The training programme for the intervention group at the schools had three sessions in 12 weeks and was about obesity, body mass index (BMI) calculation, a healthy lifestyle and coping with stress. Data was collected through a sociodemographic data form, healthy lifestyle behaviours data form, Piers-Harris Children's Self-Concept Scale and weight-height measurements during the first and last weeks of the programme (except for the sociodemographic form). Before training, BMI's of children in the intervention group were higher than in the control group (19.61 ± 3.8 vs 19.00 ± 3.5, respectively). The gap between BMI scores of the groups was narrowed after the training (p > 0.05). The mean score on the Self-Concept Scale increased in the intervention group after the training (63.21 ± 9.5) as compared to before the training (61.16 ± 10.4); whereas in the control group, there were no differences found (p = 0.908). In the intervention group, the number of children who had breakfast after the training (81.1%) increased compared to before the training (74.1%) (p = 0.001). The trainings were provided to students to increase healthy nutrition, physical activity and to decrease sedentary lifestyles.",2020,"The mean score on the Self-Concept Scale increased in the intervention group after the training (63.21 ± 9.5) as compared to before the training (61.16 ± 10.4); whereas in the control group, there were no differences found (p = 0.908).","['1609 students completed the study in the intervention and control groups (1022 vs 587, respectively', 'Children 9 and 15 years old were included from two public secondary schools', 'children during a school based obesity training programme']",[],"['healthy nutrition, physical activity', 'mean score on the Self-Concept Scale', 'BMI scores', 'number of children who had breakfast', 'BMI levels, self-concept and healthy life behaviours']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],"[{'cui': 'C5200690', 'cui_str': 'Healthy Nutrition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",1609.0,0.0158959,"The mean score on the Self-Concept Scale increased in the intervention group after the training (63.21 ± 9.5) as compared to before the training (61.16 ± 10.4); whereas in the control group, there were no differences found (p = 0.908).","[{'ForeName': 'Naime', 'Initials': 'N', 'LastName': 'Altay', 'Affiliation': 'Gazi University, Health Sciences Faculty Nursing Department, Ankara, Turkey.'}, {'ForeName': 'Ebru Kılıcarslan', 'Initials': 'EK', 'LastName': 'Toruner', 'Affiliation': 'Gazi University, Health Sciences Faculty Nursing Department, Ankara, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Akgun-Citak', 'Affiliation': 'Gazi University, Health Sciences Faculty Nursing Department, Ankara, Turkey.'}]",AIMS public health,['10.3934/publichealth.2020043']
2749,32968703,Application of  n -of-1 Clinical Trials in Personalized Nutrition Research: A Trial Protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR).,"Personalized dietary recommendations can help with more effective disease prevention. This study aims to investigate the individual postprandial glucose response to diets with diverse macronutrient proportions at both the individual level and population level, and explore the potential of the novel single-patient ( n -of-1) trial for personalization of diet. Secondary outcomes include individual phenotypic responses and the effects of dietary ingredients on the composition of gut microbiota. Westlake N-of-1 Trials for Macronutrient Intake is a multiple crossover feeding trial consisting of 3 successive 12-d dietary intervention pairs including a 6-d washout period before each 6-d isocaloric dietary intervention: a 6-d high-fat, low-carbohydrate diet, and a 6-d low-fat, high-carbohydrate diet. The results will help provide personalized dietary recommendations for macronutrients in terms of postprandial blood glucose responses. The proposed  n -of-1 trial methods could help in optimizing individual health and advancing health care. This trial was registered with clinicaltrials.gov (NCT04125602).",2020,"This study aims to investigate the individual postprandial glucose response to diets with diverse macronutrient proportions at both the individual level and population level, and explore the potential of the novel single-patient ( n -of-1) trial for personalization of diet.",[],['Macronutrient Intake'],"['postprandial blood glucose responses', 'individual phenotypic responses and the effects of dietary ingredients on the composition of gut microbiota']",[],"[{'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.0376797,"This study aims to investigate the individual postprandial glucose response to diets with diverse macronutrient proportions at both the individual level and population level, and explore the potential of the novel single-patient ( n -of-1) trial for personalization of diet.","[{'ForeName': 'Yunyi', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Zhejiang Provincial Laboratory of Life Sciences and Biomedicine, Key Laboratory of Growth Regulation and Translational Research of Zhejiang Province, School of Life Sciences, Westlake University, Hangzhou, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Zhejiang Provincial Laboratory of Life Sciences and Biomedicine, Key Laboratory of Growth Regulation and Translational Research of Zhejiang Province, School of Life Sciences, Westlake University, Hangzhou, China.'}, {'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Zhejiang Provincial Laboratory of Life Sciences and Biomedicine, Key Laboratory of Growth Regulation and Translational Research of Zhejiang Province, School of Life Sciences, Westlake University, Hangzhou, China.'}, {'ForeName': 'Ju-Sheng', 'Initials': 'JS', 'LastName': 'Zheng', 'Affiliation': 'Zhejiang Provincial Laboratory of Life Sciences and Biomedicine, Key Laboratory of Growth Regulation and Translational Research of Zhejiang Province, School of Life Sciences, Westlake University, Hangzhou, China.'}]",Current developments in nutrition,['10.1093/cdn/nzaa143']
2750,32968708,Fish oil supplementation reduces osteoarthritis-specific pain in older adults with overweight/obesity.,"Objectives


OA is a leading cause of chronic pain and disability. Next to inflammation, vascular pathology has been hypothesized to play a role in its aetiology and progression. Owing to side effects and the low efficacy of pharmacological treatments, dietary supplements are popular as alternative treatments, but evidence of efficacy is limited. We tested whether fish oil and curcumin supplementation can reduce chronic pain and OA burden in older adults.
Methods


A 16-week randomized, double-blind, placebo-controlled, 2 × 2 factorial design supplementation trial with fish oil (2000 mg/day docosahexaenoic acid + 400 mg/day eicosapentaenoic acid), curcumin (160 mg/day) or a combination of both was undertaken in sedentary overweight/obese older adults. Secondary outcomes included treatment-induced changes in self-reported chronic pain and OA burden and whether changes were related to changes in small artery elasticity (surrogate marker for microvascular function), CRP (inflammatory marker) and well-being.
Results


The majority of participants (131 of 152) reported chronic pain, which was predominantly OA specific. Fish oil significantly reduced OA-specific pain ( P  = 0.002, Cohen's  d  = 0.56) and burden ( P  = 0.015, Cohen's  d  = 0.45) compared with no fish oil treatment; reductions were correlated with improvements in microvascular function and well-being. Curcumin, alone or in combination with fish oil, did not reduce pain measures.
Conclusion


Our findings indicate potential for fish oil to alleviate OA pain and burden in overweight/obese older adults. Further investigations should be undertaken in patients with clinically diagnosed OA to evaluate fish oil alone and as an adjunct to conventional pharmacotherapy and to investigate underlying mechanisms.
Trial registration


Australian and New Zealand Clinical Trials Register, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370788, ACTRN12616000732482p.",2020,"Fish oil significantly reduced OA-specific pain ( P  = 0.002, Cohen's  d  = 0.56) and burden ( P  = 0.015, Cohen's  d  = 0.45) compared with no fish oil treatment; reductions were correlated with improvements in microvascular function and well-being.","['older adults', 'older adults with overweight/obesity', 'sedentary overweight/obese older adults', 'overweight/obese older adults', 'patients with clinically diagnosed OA']","['fish oil (2000\u2009mg/day docosahexaenoic acid + 400\u2009mg/day eicosapentaenoic acid), curcumin', 'Curcumin, alone or in combination with fish oil', 'fish oil and curcumin supplementation', 'Fish oil supplementation', 'placebo']","['chronic pain and OA burden', 'OA-specific pain', 'osteoarthritis-specific pain', 'small artery elasticity (surrogate marker for microvascular function), CRP (inflammatory marker) and well-being', 'treatment-induced changes in self-reported chronic pain and OA burden', 'pain measures', 'chronic pain', 'microvascular function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0226001', 'cui_str': 'Structure of small artery'}, {'cui': 'C0086589', 'cui_str': 'Marker, Surrogate'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.571947,"Fish oil significantly reduced OA-specific pain ( P  = 0.002, Cohen's  d  = 0.56) and burden ( P  = 0.015, Cohen's  d  = 0.45) compared with no fish oil treatment; reductions were correlated with improvements in microvascular function and well-being.","[{'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Kuszewski', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, New South Wales.'}, {'ForeName': 'Rachel H X', 'Initials': 'RHX', 'LastName': 'Wong', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, New South Wales.'}, {'ForeName': 'Peter R C', 'Initials': 'PRC', 'LastName': 'Howe', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, New South Wales.'}]",Rheumatology advances in practice,['10.1093/rap/rkaa036']
2751,32968774,Validity of Data Collected from Randomized Behavioral Clinical Trials During the COVID-19 Pandemic.,,2020,,[],[],[],[],[],[],,0.10268,,"[{'ForeName': 'Constance A', 'Initials': 'CA', 'LastName': 'Mara', 'Affiliation': ""Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Peugh', 'Affiliation': ""Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine.""}]",Journal of pediatric psychology,['10.1093/jpepsy/jsaa078']
2752,32969884,Gunsight Procedure Versus the Purse-String Procedure for Closing Wounds After Stoma Reversal: A Multicenter Prospective Randomized Trial.,"BACKGROUND


Stoma reversal is associated with a high risk of wound infection. The gunsight and purse-string closure techniques are both effective alternatives for stoma reversal, but comparative studies are lacking.
OBJECTIVE


The purpose of this study was to compare the gunsight procedure with the purse-string closure technique when closing wounds after loop stoma reversal.
DESIGN


This was a nonblinded, multicenter prospective randomized study (clinicaltrials.gov No. NCT02053948).
SETTINGS


The study was conducted at a general surgery unit of 7 tertiary academic medical centers.
PATIENTS


A total of 143 patients undergoing loop stoma reversal were included in the study (72 in the gunsight group and 71 in the purse-string group) between November 2013 and December 2017.
INTERVENTION


Patients were randomly assigned to undergo either gunsight or purse-string closure procedure.
MAIN OUTCOME MEASURES


Primary outcome was wound healing time. Secondary outcomes were the incidence of surgical site infection, morbidity, and patient satisfaction.
RESULTS


No differences were found between the 2 groups in terms of surgical site infection, intraoperative blood loss, and postoperative hospital stay. The gunsight procedure had a shorter wound healing time compared with the purse-string procedure (17 vs 25 d; p < 0.001). A patient satisfaction questionnaire showed that the gunsight group had a higher score level of patient satisfaction with respect to wound healing time (p < 0.001) and total patient satisfaction score (p = 0.01) than the purse-string group.
LIMITATIONS


Treatment teams were not blinded, and there was operator dependence of techniques.
CONCLUSIONS


The gunsight and purse-string techniques are effective procedures for stoma reversal and both have a low incidence of surgical site infection. The gunsight technique is associated with shorter wound healing time, higher levels of patient satisfaction with regard to healing time, and overall final score and is recommended as the closure technique of choice. See Video Abstract at http://links.lww.com/DCR/B319. EL PROCEDIMIENTO DE GUNSIGHT VERSUS EL PROCEDIMIENTO DE JARETA, PARA EL CIERRE DE HERIDAS, DESPUéS DE REVERSIóN DE ESTOMA: UN ENSAYO, MULTICéNTRICO, PROSPECTIVO Y RANDOMIZADO: La reversión de estoma está asociada con un alto riesgo de infección de la herida. Las técnicas de gunsight y de jareta, son eficaces alternativas en la reversión de estoma, pero faltan estudios comparativos.Comparar el procedimiento de gunsight con la técnica de jareta, después de la reversión de estoma en asa.Estudio multicéntrico, prospectivo y randomizado ciego (NCT02053948).Realizado en la unidad de cirugía general, de siete centros médicos académicos terciarios.Se incluyeron en el estudio, un total de 143 pacientes sometidos a reversión de estoma de asa (72 en el grupo de gunsight y 71 en el grupo de jareta) entre noviembre de 2013 y diciembre de 2017.Los pacientes fueron asignados aleatoriamente, para someterse a un procedimiento de cierre de gunsight o de jareta.El resultado primario fue el tiempo de cicatrización de la herida. Los resultados secundarios fueron la incidencia de infección del sitio quirúrgico, morbilidad y satisfacción del paciente.No se encontraron diferencias entre los dos grupos en términos de infección del sitio quirúrgico, pérdida de sangre intraoperatoria o estadía hospitalaria postoperatoria. El procedimiento de gunsight tuvo un tiempo más corto en la cicatrización de la herida, en comparación con el procedimiento de jareta (17 días frente a 25 días, p <0,001). Un cuestionario de satisfacción del paciente, mostró que el grupo de gunsight tenía una puntuación más alta en relación al tiempo de cicatrización de la herida (p <0.001) y la puntuación total en satisfacción del paciente (p = 0.01), que en el grupo de jareta.Los equipos de tratamiento quirúrgico, no fueron cegados y hubo en los cirujanos, dependencia en las técnicas.Las técnicas de gunsight y de jareta son procedimientos efectivos para la reversión de estoma y ambas tienen una baja incidencia de infección en el sitio quirúrgico. La técnica de gunsight está asociada con un tiempo más corto en cicatrización de heridas, mejores niveles en satisfacción del tiempo de cicatrización y en la puntuación general final. Se recomienda como la técnica de cierre de elección. Consulte Video Resumen en http://links.lww.com/DCR/B319. (Traducción-Dr Fidel Ruiz Healy).",2020,"No differences were found between the 2 groups in terms of surgical site infection, intraoperative blood loss, and postoperative hospital stay.","['y 71 en el grupo de jareta) entre noviembre', 'y ambas tienen una baja incidencia de infección en el sitio quirúrgico', '143 patients undergoing loop stoma reversal were included in the study (72 in the gunsight group and 71 in the purse-string group) between November 2013 and December 2017', 'general surgery unit of 7 tertiary academic medical centers', 'After Stoma Reversal']","['Gunsight Procedure', 'gunsight procedure with the purse-string closure technique', 'gunsight or purse-string closure procedure', 'DESPUéS', 'y diciembre']","['surgical site infection, intraoperative blood loss, and postoperative hospital stay', 'shorter wound healing time', 'total patient satisfaction score', 'wound healing time', 'incidence of surgical site infection, morbidity, and patient satisfaction']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443313', 'cui_str': 'Stringing'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0443313', 'cui_str': 'Stringing'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",143.0,0.0205797,"No differences were found between the 2 groups in terms of surgical site infection, intraoperative blood loss, and postoperative hospital stay.","[{'ForeName': 'Jia Gang', 'Initials': 'JG', 'LastName': 'Han', 'Affiliation': ""General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Hong Wei', 'Initials': 'HW', 'LastName': 'Yao', 'Affiliation': ""General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Jian Ping', 'Initials': 'JP', 'LastName': 'Zhou', 'Affiliation': ""General Surgery, the First Hospital of China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""General Surgery, Shengjing Hospital of China Medical University, Shenyang, People's Republic of China.""}, {'ForeName': 'Gui Ying', 'Initials': 'GY', 'LastName': 'Wang', 'Affiliation': ""General Surgery, the Fourth Hospital of Hebei Medical University, Hebei, People's Republic of China.""}, {'ForeName': 'Zhan Long', 'Initials': 'ZL', 'LastName': 'Shen', 'Affiliation': ""General Surgery, Peking University People's Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Jian Feng', 'Initials': 'JF', 'LastName': 'Gong', 'Affiliation': ""General Surgery, Jinling Hospital, Jiangsu, People's Republic of China.""}, {'ForeName': 'Zhen Jun', 'Initials': 'ZJ', 'LastName': 'Wang', 'Affiliation': ""General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001755']
2753,32969946,"Senna Versus Magnesium Oxide for the Treatment of Chronic Constipation: A Randomized, Placebo-Controlled Trial.","INTRODUCTION


This is the first prospective, double-blinded, randomized, placebo-controlled trial to evaluate the safety and efficacy of a stimulant laxative compared with an osmotic agent for the treatment of chronic idiopathic constipation.
METHODS


Patients were randomly administered stimulant laxative (senna, 1.0 g), osmotic agent (magnesium oxide [MgO], 1.5 g), or placebo for 28 consecutive days. The primary endpoint was overall symptom improvement. Secondary endpoints were spontaneous bowel movement (SBM), complete SBM, and patient assessment of constipation quality of life (QOL).
RESULTS


Ninety patients (mean age, 42 years; 93% women; mean duration of symptoms, 9.9 years) were enrolled; all completed the study. The response rate for overall improvement was 11.7% in the placebo group, 69.2% in the senna group, and 68.3% in the MgO group (P < 0.0001). Change in SBM was significantly greater in the senna and MgO groups than that in the placebo group (P < 0.001). Similarly, change in complete SBM was significantly greater in the senna and MgO groups than that in the placebo group (P < 0.01). On the patient assessment of constipation QOL, significant improvements were seen in the senna and MgO groups compared with those in the placebo group (senna, P < 0.05; MgO, P < 0.001). The frequency of severe treatment-related adverse events was 0%.
DISCUSSION


Senna and MgO significantly improved the frequency of bowel movements and QOL score and seem to be effective in the treatment of constipation.",2020,"The response rate for overall improvement was 11.7% in the placebo group, 69.2% in the senna group, and 68.3% in the MgO group (P < 0.0001).","['chronic idiopathic constipation', 'Chronic Constipation', 'Ninety patients (mean age, 42 years; 93% women; mean duration of symptoms, 9.9 years) were enrolled; all completed the study', 'Patients were randomly administered']","['stimulant laxative (senna, 1.0 g), osmotic agent (magnesium oxide [MgO], 1.5 g), or placebo', 'stimulant laxative', 'placebo', 'Placebo', 'Senna Versus Magnesium Oxide']","['frequency of bowel movements and QOL score', 'response rate for overall improvement', 'spontaneous bowel movement (SBM), complete SBM, and patient assessment of constipation quality of life (QOL', 'safety and efficacy', 'change in complete SBM', 'constipation QOL', 'Change in SBM', 'frequency of severe treatment-related adverse events', 'overall symptom improvement']","[{'cui': 'C0267509', 'cui_str': 'Chronic idiopathic constipation'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C0330722', 'cui_str': 'Cassia acutifolia'}, {'cui': 'C0029391', 'cui_str': 'Osmosis'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0024477', 'cui_str': 'Magnesium Oxide'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.270747,"The response rate for overall improvement was 11.7% in the placebo group, 69.2% in the senna group, and 68.3% in the MgO group (P < 0.0001).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Morishita', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Tomita', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Sumire', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Pharmacy, Hospital of Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Tadayuki', 'Initials': 'T', 'LastName': 'Oshima', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Fukui', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Miwa', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000942']
2754,32969962,Open- and closed-label placebo and nocebo suggestions about a sham transdermal patch.,"OBJECTIVE


Placebo effects may occur when it is known that an inert substance is given (i.e., open-label placebo). It is not yet clear whether these effects are similar to concealed (i.e. closed-label) placebo effects for itch, or whether nocebo effects can be induced under open-label conditions.
METHODS


Healthy volunteers (n=112) were randomized to an open-label (I) or closed-label (II) positive suggestions group, or an open-label (III) or closed-label (IV) negative suggestions group. Participants were told, as cover story, that a transdermal caffeine patch would be applied that positively influences cognitive abilities and, as a side effect, positively or negatively (depending on group allocation) influences itch. Participants in the open-label groups were given a rationale explaining placebo and nocebo effect mechanisms. Itch (the primary outcome) was induced at baseline and post-suggestions by histamine iontophoresis.
RESULTS


Analyses of variance revealed significantly lower itch in the positive compared to the negative suggestions groups for both open- and closed-label contexts (all p≤.008, Cohen's d≥0.47). Self-rated skin response was less severe following positive versus negative suggestions (all p≤.017, Cohen's d≥0.33), but no effects on physical skin response were found (all p≥.23, Cohen's d≤0.30).
CONCLUSION


Itch can be reduced by positive compared to negative suggestions under both open- and closed-label conditions. These findings indicate that open-label suggestions may potentially be a tool to utilize placebo effects for self-reported outcomes in clinical practice, for example by explaining the role of expectancy in treatment. It needs to be investigated further under which circumstances an open-label rationale may impact placebo and nocebo effects.",2020,"Analyses of variance revealed significantly lower itch in the positive compared to the negative suggestions groups for both open- and closed-label contexts (all p≤.008, Cohen's d≥0.47).",['Healthy volunteers (n=112'],"['placebo', 'Open- and closed-label placebo', 'open-label (I) or closed-label (II) positive suggestions group, or an open-label (III) or closed-label (IV) negative suggestions group']","['Self-rated skin response', 'physical skin response']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",112.0,0.105296,"Analyses of variance revealed significantly lower itch in the positive compared to the negative suggestions groups for both open- and closed-label contexts (all p≤.008, Cohen's d≥0.47).","[{'ForeName': 'Stefanie H', 'Initials': 'SH', 'LastName': 'Meeuwis', 'Affiliation': 'Leiden University, Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden, the Netherlands.'}, {'ForeName': 'Henriët', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': 'Leiden University, Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden, the Netherlands.'}, {'ForeName': 'Adriana P M', 'Initials': 'APM', 'LastName': 'Lavrijsen', 'Affiliation': 'Department of Dermatology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Leiden University, Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden, the Netherlands.'}, {'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Leiden University, Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden, the Netherlands.'}]",Psychosomatic medicine,['10.1097/PSY.0000000000000862']
2755,32970035,Body-Worn Versus Bell-and-Pad Alarm Device for the Management of Monosymptomatic Nocturnal Enuresis in Children: A Randomized Controlled Trial.,"PURPOSE


The purpose of this study was to compare the effectiveness of bell-and-pad alarm therapy to body-worn alarm therapy for the management of monosymptomatic enuresis in children 6 to 16 years of age.
DESIGN


A prospective, randomized, adaptive clinical control trial.
SUBJECTS AND SETTING


The sample comprised 86 children who attended a continence clinic for treatment of monosymptomatic enuresis and met the criteria for enuresis alarm therapy as per International Children's Continence Society (ICCS) guidelines. Subjects were randomly allocated to an experimental group (body-worn alarm, n = 41) or a control group (bell-and-pad alarm, n = 45). The study setting was a single-site specialist continence service in regional Victoria, Australia. Treatment was administered in the child's home.
METHODS


Alarm therapy was administered by the child and/or parent for an initial period of 8 weeks at which time the child underwent a review with the continence nurse specialist. If the child had achieved 14 consecutive dry nights, the therapy was deemed successful and ceased. Children who had not become dry continued therapy for a further 8 weeks up to a maximum of 16 weeks, with a final review was instituted. Each child kept a diary for the duration of alarm therapy to report on frequency of wet/dry nights, times of alarm, response to alarm, and response to sensation to void (without alarm). The 2 types of alarm devices were compared with respect to categorical variables using dichotomous cross-tabulations and χ tests of independence based on the most positive outcome versus the other outcomes.
RESULTS


Dryness in accordance with the criteria outlined by the ICCS guidelines was achieved in 18 children (43.9%) in the body-worn alarm group versus 29 children (64.4%) in the routine (bell-and-pad) group (P = .056). The bell-and-pad alarm performed better on 7 out of the 9 indicators, including the primary outcome measure of the child attained dryness for 14 nights or more, nightly alarm use, alarm woke child, alarm woke parent (P = .022), false (positive) alarms (P = .039), child turned alarm off and went back to sleep (P = .003), and child was compliant with alarm use. The body-worn device produced higher proportions of the most positive outcomes for 2 of the 9 indicators: relapse (P = .076) and false (negative) nonalarms (P = .066).
CONCLUSIONS


Study findings suggests that the bell-and-pad alarm is preferable to the body-worn alarm. Additional research is recommended using other body-worn alarm devices across a larger population in order to establish the more definitive findings needed for clinical decision-making.",2020,"The bell-and-pad alarm performed better on 7 out of the 9 indicators, including the primary outcome measure of the child attained dryness for 14 nights or more, nightly alarm use, alarm woke child, alarm woke parent (P = .022), false (positive) alarms (P =","[""86 children who attended a continence clinic for treatment of monosymptomatic enuresis and met the criteria for enuresis alarm therapy as per International Children's Continence Society (ICCS) guidelines"", 'monosymptomatic enuresis in children 6 to 16 years of age', 'Monosymptomatic Nocturnal Enuresis in Children']","['Body-Worn Versus Bell-and-Pad Alarm Device', 'bell-and-pad alarm therapy to body-worn alarm therapy']","['frequency of wet/dry nights, times of alarm, response to alarm, and response to sensation to void (without alarm', 'child attained dryness for 14 nights or more, nightly alarm use, alarm woke child, alarm woke parent (P = .022), false (positive) alarms', 'child turned alarm off and went back to sleep']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014394', 'cui_str': 'Enuresis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0178997', 'cui_str': 'Nocturnal bladder warning system'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0270327', 'cui_str': 'Nocturnal enuresis'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",86.0,0.0885035,"The bell-and-pad alarm performed better on 7 out of the 9 indicators, including the primary outcome measure of the child attained dryness for 14 nights or more, nightly alarm use, alarm woke child, alarm woke parent (P = .022), false (positive) alarms (P =","[{'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Peck', 'Affiliation': 'Blake Peck, School of Health, Federation University Australia, Ballarat, Victoria, Australia. Bronwyn Peck, Grampians Regional Continence Service, Ballarat Health Services, Ballarat, Victoria, Australia. Jack Harvey, School of Science, Psychology and Sport Federation University Australia, Ballarat, Victoria, Australia. Andrea Green, Grampians Regional Continence Service, Ballarat Health Services, Ballarat, Victoria, Australia. Kerrie Svedas, Grampians Regional Continence Service, Ballarat Health Services, Ballarat, Victoria, Australia. Shirley Whitaker, Grampians Regional Continence Service, Ballarat Health Services, Ballarat, Victoria, Australia. Mark Nethercote, Grampians Regional Continence Service, Ballarat Health Services, Ballarat, Victoria, Australia. Rosemarie Shea, St John of God Ballarat, Ballarat, Victoria, Australia.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Peck', 'Affiliation': ''}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Harvey', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Kerrie', 'Initials': 'K', 'LastName': 'Svedas', 'Affiliation': ''}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Whitaker', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nethercote', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Rosemarie Shea', 'Affiliation': ''}]","Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society",['10.1097/WON.0000000000000678']
2756,32970104,Efficacy of Plinabulin vs Pegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Adults With Non-Small Cell Lung Cancer: A Phase 2 Randomized Clinical Trial.,"Importance


Plinabulin is a novel, non-granulocyte colony-stimulating factor (GCSF) small molecule with both anticancer and neutropenia-prevention effects.
Objective


To assess the efficacy and safety of plinabulin compared with pegfilgrastim for the prevention of chemotherapy-induced neutropenia following docetaxel chemotherapy in patients with non-small lung cancer.
Design, Setting, and Participants


This was a randomized, open-label, phase 2 clinical trial of 4 treatment arms that was conducted in 19 cancer treatment centers in the United States, China, Russia, and Ukraine. Participants were adult patients with non-small cell lung cancer whose cancer had progressed after platinum-based chemotherapy. Data were collected from April 2017 through March 2018 and analyzed from August 2019 through February 2020.
Interventions


All patients received docetaxel 75 mg/m2 on day 1 and were randomly assigned to 1 of 3 doses of plinabulin (5, 10, or 20 mg/m2) on day 1 or to pegfilgrastim 6 mg on day 2. Patients were treated every 21 days for 4 chemotherapy cycles.
Main Outcomes and Measures


The primary end point was the determination of the recommended phase 3 dose of plinabulin based on the days of severe neutropenia during chemotherapy cycle 1. Daily complete blood cell counts and absolute neutrophil counts were drawn during times of anticipated neutropenia during cycle 1.
Results


Of the 55 patients randomized and evaluated, the mean (SD) age was 61.3 (10.2) years, and 38 (69.1%) were men. With each escalation of the plinabulin dose, the incidence of any grade of neutropenia decreased. There were no significant differences in mean (SD) days of severe neutropenia among those treated with pegfilgrastim (0.15 [0.38] days) when dosed at day 2 vs plinabulin 20 mg/m2 (0.36 [0.93] days; P = .76) when dosed at day 1, and no safety signals were detected.
Conclusions and Relevance


Single dose-per-cycle plinabulin has a similar neutropenia protection benefit as pegfilgrastim. Plinabulin 40 mg fixed dose, which is pharmacologically equivalent to 20 mg/m2, will be compared with pegfilgrastim 6 mg in the phase 3 portion of this trial. Noninferior days of severe neutropenia will be the primary end point, and bone pain reduction, thrombocytopenia reduction, and quality of life maintenance will be secondary end points.
Trial Registration


ClinicalTrials.gov Identifier: NCT03102606.",2020,"With each escalation of the plinabulin dose, the incidence of any grade of neutropenia decreased.","['19 cancer treatment centers in the United States, China, Russia, and Ukraine', 'the mean (SD) age was 61.3 (10.2) years, and 38 (69.1%) were men', 'Participants were adult patients with non-small cell lung cancer whose cancer had progressed after platinum-based chemotherapy', 'Adults With Non-Small Cell Lung Cancer', 'Data were collected from April 2017 through March 2018 and analyzed from August 2019 through February 2020', 'patients with non-small lung cancer']","['docetaxel chemotherapy', 'pegfilgrastim', 'plinabulin', 'docetaxel', 'Plinabulin vs Pegfilgrastim']","['severe neutropenia', 'efficacy and safety', 'mean (SD) days of severe neutropenia', 'bone pain reduction, thrombocytopenia reduction, and quality of life maintenance', 'Daily complete blood cell counts and absolute neutrophil counts']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0265783', 'cui_str': 'Congenital hypoplasia of lung'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0151825', 'cui_str': 'Bone pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}]",55.0,0.0885841,"With each escalation of the plinabulin dose, the incidence of any grade of neutropenia decreased.","[{'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Blayney', 'Affiliation': 'Stanford Cancer Institute, Stanford, California.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Oncology, Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu Cancer Hospital and Jiangsu Institute of Cancer Research, Nanjing, China.'}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnipropetrovsk Medical Academy, Ukraine. Dnepropetrovsk, Ukraine.'}, {'ForeName': 'Ihor', 'Initials': 'I', 'LastName': 'Vynnychenko', 'Affiliation': 'Sumy Regional Clinical Oncology Dispensary, Sumy State University, Sumy, Ukraine.'}, {'ForeName': 'Nadezhda', 'Initials': 'N', 'LastName': 'Kovalenko', 'Affiliation': 'Volgograd Regional Clinical Oncology Dispensary, Volgograd, Russia.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Mid Florida Hematology and Oncology Center, Orange City.'}, {'ForeName': 'Emad', 'Initials': 'E', 'LastName': 'Ibrahim', 'Affiliation': 'Redlands Community Hospital, Redlands, California.'}, {'ForeName': 'Dmitriy Petrovich', 'Initials': 'DP', 'LastName': 'Udovista', 'Affiliation': 'SBI of Healthcare Oncology Dispensary No. 2, Ministry of Health of Krasnodar Region, Sochi, Russia.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Mohanlal', 'Affiliation': 'BeyondSpring Pharmaceuticals, New York, New York.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ogenstad', 'Affiliation': 'Statogen Consulting, Wake Forest, North Carolina.'}, {'ForeName': 'Ene', 'Initials': 'E', 'LastName': 'Ette', 'Affiliation': 'Anoixis Corporation, Natick, Massachusetts.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Wanchun Bulin Pharmaceuticals Limited, Dalian, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'BeyondSpring Pharmaceuticals, New York, New York.'}, {'ForeName': 'Yuan-Kai', 'Initials': 'YK', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",JAMA oncology,['10.1001/jamaoncol.2020.4429']
2757,32970162,Results of a randomized controlled phase III trial: efficacy of polyphenol-containing cystus® tea mouthwash solution for the reduction of mucositis in head and neck cancer patients undergoing external beam radiotherapy.,"PURPOSE


To determine the effect of Cystus® tea (Naturprodukte Dr. Pandalis GmbH & Co. KG) as mouthwash compared to sage tea on oral mucositis in patients undergoing radio(chemo)therapy for head and neck cancer.
METHODS


In this randomized, prospective phase III study, 60 head and neck cancer patients with primary or postoperative radio(chemo)therapy were included between 04/2012 and 06/2014. They received either sage or Cystus® tea for daily mouthwash under therapy. Mucositis was scored twice a week following the Radiation Therapy Oncology Group and the European Organization for Research and Treatment Cancer (RTOG/EORTC) scoring system. Dental parameters were also recorded. Statistical evaluation of the primary endpoint was performed using t‑test and log rank test.
RESULTS


Data from 57 patients could be evaluated. Patient characteristics showed no significant difference between the two groups (n = 27 sage; n = 30 Cystus®). A total of 55 patients received the prescribed dose (60-66 Gy postoperative; 70-76.8 Gy primary). Mucositis grade 3 was observed in 23 patients (n = 11 sage; n = 12 Cystus®) and occurred between day 16 and 50 after start of therapy. There was no significant difference between the two groups in latency (p = 0.75) and frequency (p = 0.85) of the occurrence of mucositis grade 3. The self-assessment of the oral mucosa and the tolerability of the tea also showed no significant differences. Occurrence of dental pathologies appeared to increase over time after radiotherapy.
CONCLUSION


Cystus® and sage tea have a similar effect on the occurrence of radiation-induced mucositis regarding latency and incidence. Cystus® tea mouthwash solution is tolerated well and can be applied in addition to intensive oral care and hygiene along with the application of fluorides.",2020,Patient characteristics showed no significant difference between the two groups (n = 27 sage; n = 30 Cystus®).,"['60\xa0head and neck cancer patients with primary or postoperative radio(chemo)therapy were included between 04/2012 and 06/2014', 'head and neck cancer patients undergoing external beam radiotherapy', 'patients undergoing radio(chemo)therapy for head and neck cancer']","['sage or Cystus® tea', 'polyphenol-containing cystus® tea mouthwash solution', 'sage tea', 'Cystus® and sage tea', 'Cystus® tea (Naturprodukte Dr. Pandalis GmbH & Co. KG']","['Occurrence of dental pathologies', 'mucositis', 'Mucositis', 'Mucositis grade\xa03']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C1122976', 'cui_str': 'Sage'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]",,0.0436231,Patient characteristics showed no significant difference between the two groups (n = 27 sage; n = 30 Cystus®).,"[{'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Ebert', 'Affiliation': 'German Cancer Research Center (DKFZ), Heidelberg, Germany. nadja.ebert@uniklinikum-dresden.de.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kensche', 'Affiliation': 'Clinic of Operative and Pediatric Dentistry, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Löck', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Wahyu Wijaya', 'Initials': 'WW', 'LastName': 'Hadiwikarta', 'Affiliation': 'German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hänsch', 'Affiliation': 'Clinic of Operative and Pediatric Dentistry, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Dörr', 'Affiliation': ''}, {'ForeName': 'Mechthild', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hannig', 'Affiliation': 'Clinic of Operative and Pediatric Dentistry, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baumann', 'Affiliation': 'German Cancer Research Center (DKFZ), Heidelberg, Germany.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01684-y']
2758,32966105,Donor Cell Fate in Particulated Juvenile Allograft Cartilage for the Repair of Articular Cartilage Defects.,"BACKGROUND


Particulated juvenile allograft cartilage (PJAC) has demonstrated good clinical efficacy in repairing articular cartilage defects, but the related repair mechanism after transplant and the biological characteristics of the transplanted cells are still unclear.
PURPOSE


To study the efficacy of PJAC in repairing full-thickness cartilage defects and the specific fate of donor cells to provide experimental evidence for its clinical application.
STUDY DESIGN


Controlled laboratory study.
METHODS


Twenty female Guizhou minipigs were randomly divided into an experimental group and a control group. An 8-mm cylindrical full-thickness cartilage defect was created in the femoral trochlea of 1 knee in all minipigs. The experimental group received transplant of PJAC from 5 male juvenile Guizhou minipigs (PJAC group; n = 10) and the control group received autologous cartilage chips (ACC group; n = 10). Follow-up assessments were conducted at 1 month and 3 months to track the transplanted cells by the male-specific sex-determining region Y-linked (SRY) gene; tissue sections were hybridized in situ, and O'Driscoll histological scoring was performed according to hematoxylin and eosin staining, safranin O and fast green staining, and toluidine blue O staining, as well as immunohistochemical evaluation of aggrecan and Sry-type HMG-box 9 (SOX9).
RESULTS


All 20 Guizhou minipigs were followed; no infection or incision healing disorder occurred after the operation. By SRY in situ hybridization, the SRY signal of the transplanted cells was positive in the repaired tissue of the defect, and the SRY positive signal could still be detected in repaired tissue at 3 months postoperatively. The average number of positive cells was 68.6 ± 11.91 at 1 month and 32.6 ± 3.03 at 3 months (confocal microscope: ×400), and the difference was statistically significant. The O'Driscoll histological scores were 14 ± 0.71 in the ACC group and 9.8 ± 0.84 in the PJAC group at 1 month, and 18 ± 1.20 in the ACC group and 17.4 ± 1.14 in the PJAC group at 3 months. The scores were statistically significant between the ACC group and PJAC group at 1 month. The positive rates of SOX9 in the PJAC and ACC groups at 1 month were 67.6% ± 3.78% and 63.4% ± 5.30%, respectively, and the difference was not statistically significant ( P  > .05). The positive rates of SOX9 in the PJAC and ACC groups at 3 months were 68.8% ± 2.69% and 17.1% ± 1.26%, respectively, and the difference was statistically significant ( P  < .05). The positive rates of aggrecan in the PJAC and ACC groups at 1 month were 40.5% ± 2.78% and 42.4% ± 0.54% respectively, and the difference was not statistically significant ( P  > .05). The positive rates of aggrecan in the PJAC and ACC groups at 3 months were 40.8% ± 1.50% and 30.1% ± 2.44%, respectively, and the difference was not statistically significant ( P  > .05).
CONCLUSION


An animal model was established with Guizhou minipigs, and the cartilage defect was repaired with PJAC from male minipigs. The SRY gene positive signal could be detected from the repaired tissue by in situ hybridization, indicating that the transplanted cells survived at least 3 months. The key genes of cartilage formation, SOX9 and aggrecan, were expressed at 1 month and 3 months, and SOX9 expression was stronger in the PJAC group than the ACC group at 3 months.
CLINICAL RELEVANCE


This study suggests that it is feasible to study the biological characteristics of transplanted cells in the cartilage region by the sex-determining gene.",2020,"The key genes of cartilage formation, SOX9 and aggrecan, were expressed at 1 month and 3 months, and SOX9 expression was stronger in the PJAC group than the ACC group at 3 months.
","['Twenty female Guizhou minipigs', 'from 5 male juvenile Guizhou minipigs (PJAC group; n = 10) and the']","['PJAC', 'Particulated juvenile allograft cartilage (PJAC', 'control group received autologous cartilage chips (ACC', 'transplant of PJAC']","[""O'Driscoll histological scores"", 'infection or incision healing disorder', 'cartilage formation, SOX9 and aggrecan', 'positive rates of SOX9', 'positive rates of aggrecan', 'SOX9 expression', 'average number of positive cells']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039011', 'cui_str': 'Miniature Swine'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0598067', 'cui_str': 'Cartilage formation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0081487', 'cui_str': 'Aggrecan'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]",5.0,0.0335541,"The key genes of cartilage formation, SOX9 and aggrecan, were expressed at 1 month and 3 months, and SOX9 expression was stronger in the PJAC group than the ACC group at 3 months.
","[{'ForeName': 'Changgui', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Yunong', 'Initials': 'Y', 'LastName': 'Ao', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Duan', 'Affiliation': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}]",The American journal of sports medicine,['10.1177/0363546520958700']
2759,32966120,Aging reduces the maximal level of peripheral fatigue tolerable and impairs exercise capacity.,"The aim of the present study was to determine the magnitude of the maximal level of peripheral fatigue attainable (fatigue threshold) during all-out intermittent isometric knee-extensor protocol in both young (24±1years, N=12) and older participants (60±2years, N=12) to provide new insights on the effects of aging on neuromuscular function. Participants performed two experimental sessions, in which they performed 60 maximal voluntary contractions (MVC; 3s-contraction, 2s-relaxation). One trial was performed in the unfatigued state (CTRL) and one other following fatiguing neuromuscular electrical stimulation of the quadriceps (F NMES ). Peripheral fatigue was quantified via pre/post-exercise decrease in quadriceps twitch-force (∆P tw ). Critical force (CF) was determined as the mean force output of the last 12 contractions while W' was calculated as the area above CT. While F NMES  led to significant decrease in P tw  prior to performing the 60 MVCs protocol (P<0.05), ∆P tw  was not different between CTRL and F NMES  for both the young (P=0.49) and the old (P=0.52) group. However, this peripheral fatigue threshold was significantly greater in young vs old participants (∆P tw  = -48±10 vs -29±13%, respectively, P<0.05). In CTRL, W' was 55 ± 13 % lower in the old compared to the young group (P<0.01), but CT was similar (326±10 vs 322±12N, respectively, P=0.94). ∆P tw  was correlated with W', independently of age (r 2 =0.84, P<0.001). Exercise performance decreases with aging consequent to a lower tolerance to peripheral fatigue. However, the peripheral fatigue threshold mechanism persists with healthy aging and continues to play its protective role to preserve locomotor muscle function during exercise.",2020,"While F NMES  led to significant decrease in P tw  prior to performing the 60 MVCs protocol (P<0.05), ∆P tw  was not different between CTRL and F NMES  for both the young (P=0.49) and the old (P=0.52) group.","['both young (24±1years, N=12) and older participants (60±2years, N=12']",['peripheral fatigue attainable (fatigue threshold) during all-out intermittent isometric knee-extensor protocol'],"['Critical force (CF', 'Peripheral fatigue', 'maximal level of peripheral fatigue tolerable and impairs exercise capacity', 'peripheral fatigue threshold', 'quadriceps twitch-force (∆P tw ']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}]",60.0,0.0251441,"While F NMES  led to significant decrease in P tw  prior to performing the 60 MVCs protocol (P<0.05), ∆P tw  was not different between CTRL and F NMES  for both the young (P=0.49) and the old (P=0.52) group.","[{'ForeName': 'Slim', 'Initials': 'S', 'LastName': 'Zarzissi', 'Affiliation': 'University of Sfax, High Institute of Sport and Physical Education, Education, Motor Skills, Sport and Health (EM2S) laboratory, LR19JS01, Sfax, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Bouzid', 'Affiliation': 'University of Sfax, High Institute of Sport and Physical Education, Education, Motor Skills, Sport and Health (EM2S) laboratory, LR19JS01, Sfax, Tunisia.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Zghal', 'Affiliation': 'University of Sfax, High Institute of Sport and Physical Education, Education, Motor Skills, Sport and Health (EM2S) laboratory, LR19JS01, Sfax, Tunisia.'}, {'ForeName': 'Haithem', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': 'University of Sfax, High Institute of Sport and Physical Education, Education, Motor Skills, Sport and Health (EM2S) laboratory, LR19JS01, Sfax, Tunisia.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hureau', 'Affiliation': 'University of Strasbourg, Faculty of Medicine, Mitochondria, Oxidative Stress and Muscular Protection laboratory (UR 3072), Strasbourg, France; University of Strasbourg, Faculty of Sport Sciences, European Centre for Education, Research and Innovation in Exercise Physiology (CEERIPE), Strasbourg, France.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00151.2020']
2760,32966123,Effects of L-type voltage-gated Ca 2+  channel blockade on cholinergic and thermal sweating in habitually trained and untrained men.,"We evaluated the hypothesis that the activation of L-type voltage-gated Ca 2+  channels contribute to exercise training-induced augmentation in cholinergic sweating. On separate days, 10 habitually trained and 10 untrained men participated in two experimental protocols. Prior to each protocol, we administered 1% verapamil (Verapamil, L-type voltage-gated Ca 2+  channel blocker) and saline (Control) at forearm skin sites on both arms via transdermal iontophoresis. In Protocol 1, we administered low (0.001%) and high (1%) doses of pilocarpine at both the verapamil-treated and untreated forearm sites. In protocol 2, participants were passively heated by immersing their limbs in hot water (43°C) until rectal temperature increased by 1.0°C above baseline resting levels. Sweat rate at all forearm sites were continuously measured throughout both protocols. Pilocarpine-induced sweating in Control was higher in trained than in untrained men for both concentrations of pilocarpine (both P≤0.001). Pilocarpine-induced sweating at the low dose site was attenuated at the Verapamil versus Control site in both groups (both P≤0.004), albeit the reduction was greater in trained as compared to untrained men (P=0.005). The verapamil-mediated reduction in sweating remained intact at the high dose pilocarpine site in the untrained (P=0.004) but not the trained men (P=0.180). Sweating did not differ between Control and Verapamil sites with increases in rectal temperature in both groups (interaction, P=0.571). We show that activation of L-type voltage-gated Ca 2+  channels modulates sweat production in habitually trained men induced by a low dose of pilocarpine. However, no effect on sweating was observed during passive heating in either group.",2020,Pilocarpine-induced sweating in Control was higher in trained than in untrained men for both concentrations of pilocarpine (both P≤0.001).,"['habitually trained men', '10 habitually trained and 10 untrained men participated in two experimental protocols', 'habitually trained and untrained men']","['verapamil-treated and untreated forearm sites', 'Pilocarpine', 'verapamil (Verapamil, L-type voltage-gated Ca 2+  channel blocker) and saline (Control', 'L-type voltage-gated Ca 2+  channel blockade', 'Verapamil', 'pilocarpine', 'verapamil']","['sweating in Control', 'sweating', 'rectal temperature', 'Sweating', 'cholinergic and thermal sweating', 'Sweat rate']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0031923', 'cui_str': 'Pilocarpine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0242893', 'cui_str': 'Acetylcholine Agents'}]",,0.0322647,Pilocarpine-induced sweating in Control was higher in trained than in untrained men for both concentrations of pilocarpine (both P≤0.001).,"[{'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Fuculty of Education, Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Faculty of Health and Sport Sciences, Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Japan.'}, {'ForeName': 'Glen P', 'Initials': 'GP', 'LastName': 'Kenny', 'Affiliation': 'School of Human Kinetics, Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Fuculty of Education, Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Laboratory for Human Performance Research, Laboratory for Human Performance Research, Osaka International University, Osaka, Japan.'}, {'ForeName': 'Narihiko', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Applied Physiology Laboratory, Laboratory for Applied Human Physiology, Graduate School of Human Development and Environment, Kobe University, Kobe, Japan.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00167.2020']
2761,32966280,Molecular classification of the placebo effect in nausea.,"In this proof-of-concept study, we tested whether placebo effects can be monitored and predicted by plasma proteins. In a randomized controlled design, 90 participants were exposed to a nauseating stimulus on two separate days and were randomly allocated to placebo treatment or no treatment on the second day. Significant placebo effects on nausea, motion sickness, and (in females) gastric activity could be verified. Using label-free tandem mass spectrometry, 74 differentially regulated proteins were identified as correlates of the placebo effect. Gene ontology (GO) enrichment analyses identified acute-phase proteins and microinflammatory proteins to be involved, and the identified GO signatures predicted day-adjusted scores of nausea indices in the placebo group. We also performed GO enrichment analyses of specific plasma proteins predictable by the experimental factors or their interactions and identified 'grooming behavior' as a prominent hit. Finally, Receiver Operator Characteristics (ROC) allowed to identify plasma proteins differentiating placebo responders from non-responders, comprising immunoglobulins and proteins involved in oxidation reduction processes and complement activation. Plasma proteomics is a promising tool to identify molecular correlates and predictors of the placebo effect in humans.",2020,"Significant placebo effects on nausea, motion sickness, and (in females) gastric activity could be verified.",['90 participants were exposed to a nauseating stimulus on two separate days'],['placebo'],"['nausea', 'nausea, motion sickness, and (in females) gastric activity']","[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",90.0,0.243193,"Significant placebo effects on nausea, motion sickness, and (in females) gastric activity could be verified.","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Meissner', 'Affiliation': 'Institute of Medical Psychology, Faculty of Medicine, LMU Munich, Munich, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Lutter', 'Affiliation': 'Institute of Diabetes and Obesity, Helmholtz Diabetes Center, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'von Toerne', 'Affiliation': 'Research Unit Protein Science, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Haile', 'Affiliation': 'Institute of Medical Psychology, Faculty of Medicine, LMU Munich, Munich, Germany.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Woods', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Metabolic Diseases Institute, University of Cincinnati, Cincinnati, Ohio, United States of America.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Hoffmann', 'Affiliation': 'Institute of Medical Psychology, Faculty of Medicine, LMU Munich, Munich, Germany.'}, {'ForeName': 'Uli', 'Initials': 'U', 'LastName': 'Ohmayer', 'Affiliation': 'Research Unit Protein Science, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Stefanie M', 'Initials': 'SM', 'LastName': 'Hauck', 'Affiliation': 'Research Unit Protein Science, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}, {'ForeName': 'Matthias H', 'Initials': 'MH', 'LastName': 'Tschoep', 'Affiliation': 'Institute of Diabetes and Obesity, Helmholtz Diabetes Center, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany.'}]",PloS one,['10.1371/journal.pone.0238533']
2762,32966475,Defatted flaxseed flour improves weight loss and lipid profile in overweight and obese adults: a randomized controlled trial.,"SCOPE


Studies have suggested that foods rich in dietary fiber may contribute to body weight loss and lower triacylglycerol (TG) levels. This study aimed to investigate the effect of flaxseed meal (FM) (a by-product of flaxseed after oil processing) supplemented biscuits on body weight, body composition, and blood lipids in overweight and obese participants.
METHOD AND RESULTS


In a double-blind randomized controlled trial, 53 overweight and obese adults (18-36 years of age) were recruited and randomized to consume control biscuits or biscuits supplemented with FM for their breakfast for 60 days (approximately 100 g per day). Significant group × time interaction (P = 0.011) was observed for body weight, and the body weight of the FM group was significantly lower than that of the control group (P = 0.049). We also found significant group × time interactions for body mass index (BMI) (P = 0.008), TG (P = 0.041) and interleukin-6 (IL-6) (P = 0.016). In addition, after 60 days of intervention, the body weight, BMI and TG levels of the FM group significantly decreased compared to those of the control group. On day 60, the serum concentration of IL-6 in the FM group was significantly lower than that in the control group.
CONCLUSIONS


FM supplemented biscuits have a beneficial effect on body weight, BMI and TG of overweight and obese subjects (ClinicalTrials.gov registration number: ChiCTR1900022833).",2020,"On day 60, the serum concentration of IL-6 in the FM group was significantly lower than that in the control group.
","['overweight and obese adults', 'overweight and obese participants', '53 overweight and obese adults (18-36 years of age']","['flaxseed meal (FM', 'consume control biscuits or biscuits supplemented with FM', 'Defatted flaxseed flour']","['body weight, body composition, and blood lipids', 'time interactions for body mass index (BMI', 'serum concentration of IL-6', 'body weight, BMI and TG of overweight', 'time interaction', 'body weight, and the body weight', 'body weight, BMI and TG levels', 'body weight loss and lower triacylglycerol (TG) levels', 'weight loss and lipid profile', 'interleukin-6 (IL-6']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0023753', 'cui_str': 'Linum'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0995001', 'cui_str': 'Flaxseed extract'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",53.0,0.0437717,"On day 60, the serum concentration of IL-6 in the FM group was significantly lower than that in the control group.
","[{'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Kuang', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China. duoli@qdu.edu.cn and School of Public Health, Qingdao University, Qingdao, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China. duoli@qdu.edu.cn and School of Public Health, Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China. duoli@qdu.edu.cn and School of Public Health, Qingdao University, Qingdao, China.'}, {'ForeName': 'Kelei', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China. duoli@qdu.edu.cn and School of Public Health, Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China. duoli@qdu.edu.cn and School of Public Health, Qingdao University, Qingdao, China.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China. duoli@qdu.edu.cn and School of Public Health, Qingdao University, Qingdao, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': 'Department of Clinical Nutrition, Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao, China. duoli@qdu.edu.cn and School of Public Health, Qingdao University, Qingdao, China.'}]",Food & function,['10.1039/d0fo00838a']
2763,32966558,Results of a feasibility study of Helpers Stay Quit Training for smoking relapse prevention.,"INTRODUCTION


Most smoking quit attempts end in relapse, and interventions focused on relapse prevention are lacking. Helpers Stay Quit (HSQ) is a novel behavioral relapse prevention intervention that teaches newly abstinent smokers to offer a ""helping conversation"" (HC) to help others quit tobacco.
METHODS


Pre-post intervention feasibility study with state quitline participants ≥ 14 days abstinent. Measures at baseline, 3- and 6 months included: smoking status, offering of HCs, and cessation self-efficacy. Primary outcomes: self-reported 7-day point prevalence abstinence; offering HCs. Cox models explored association of HCs with relapse. Preliminary effects analysis using propensity score matching compared 30-day abstinence of quitline clients with study sample at 7-months.
RESULTS


Participants (N=104) were: mean age of 53 years (SD 13.9 years), 48.1% male, mean of cigarettes smoked/day of 16.2 (SD 9.7). Compared to participants who remained abstinent (n=82), relapsers (n=22) had fewer HCs over 6 months (2.6 vs. 7.2 (95%CI: 1.4, 7.8, p = 0.006). Using adjusted Cox regression, the hazard ratio of relapse for each HC was 0.85 (95%CI: 0.74, 0.99, p = 0.03). Compared to a matched sample of quitline clients not exposed to HSQ, study participants were 49% more likely to report 30-day abstinence at 7-month quitline follow-up (95% CI: 40%, 59%, p<0.0001).
CONCLUSIONS


HSQ, delivered to newly abstinent smokers who received standard quitline treatment, was associated with less self-reported relapse. These promising preliminary study results warrant further research to evaluate HSQ as a novel behavioral intervention to prevent smoking relapse.
IMPLICATIONS


To date, behavioral interventions for smoking relapse prevention that teach abstainers cessation skills to apply to themselves have not shown effectiveness. This feasibility study examines the preliminary efficacy of a conceptually novel, ""help others"" behavioral intervention approach for relapse prevention in newly abstinent smokers recruited from a state quitline. Helpers Stay Quit teaches the newly abstinent smoker communication and listening skills to encourage other smokers in their personal social network to quit. Exploratory analysis using propensity score matching suggest that participants exposed to HSQ were significantly more likely to self-report 30-day abstinence at quitline 7-month follow-up than other quitline clients.",2020,"Compared to participants who remained abstinent (n=82), relapsers (n=22) had fewer HCs over 6 months (2.6 vs. 7.2","['newly abstinent smokers recruited from a state quitline', 'Participants (N=104) were: mean age of 53 years (SD 13.9 years), 48.1% male, mean of cigarettes smoked/day of 16.2 (SD 9.7', 'quitline clients with study sample at', 'state quitline participants ≥ 14 days abstinent']","['standard quitline treatment', 'Helpers Stay Quit Training', 'conceptually novel, ""help others"" behavioral intervention approach']","['self-reported 7-day point prevalence abstinence; offering HCs', 'Helpers Stay Quit teaches', 'hazard ratio of relapse', 'self-report 30-day abstinence', '30-day abstinence', 'smoking status, offering of HCs, and cessation self-efficacy', 'Helpers Stay Quit (HSQ']","[{'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0032052', 'cui_str': 'Human placental lactogen'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",104.0,0.0233105,"Compared to participants who remained abstinent (n=82), relapsers (n=22) had fewer HCs over 6 months (2.6 vs. 7.2","[{'ForeName': 'Myra L', 'Initials': 'ML', 'LastName': 'Muramoto', 'Affiliation': 'Dept. of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Hopkins', 'Affiliation': 'Department of Anthropology, Texas A&M University, College Station, Texas.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Dept. of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Dept. of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bell', 'Affiliation': 'Dept. of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Connolly', 'Affiliation': ''}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa176']
2764,32966563,Immediate Biochemical Changes After Gait Biofeedback in Individuals With Anterior Cruciate Ligament Reconstruction.,"CONTEXT


Gait biomechanics are linked to biochemical changes that contribute to the development of posttraumatic knee osteoarthritis in individuals with anterior cruciate ligament reconstruction (ACLR). It remains unknown if modifying peak loading during gait using real-time biofeedback will result in acute biochemical changes related to cartilage metabolism.
OBJECTIVE


To determine if acutely manipulating peak vertical ground reaction force (vGRF) during gait influences acute changes in serum cartilage oligomeric matrix protein concentration (sCOMP) among individuals with ACLR.
DESIGN


Crossover study.
PATIENTS OR OTHER PARTICIPANTS


Thirty individuals with unilateral ACLR participated (70% female, age = 20.43 ± 2.91 years old, body mass index = 24.42 ± 4.25, months post-ACLR = 47.83 ± 26.97). Additionally, we identified a subgroup of participants who demonstrated an increase in sCOMP after the control or natural loading condition (sCOMPCHANGE > 0 ng/mL, n = 22, 70% female, age = 20.32 ± 3.00 years old, body mass index = 24.73 ± 4.33, months post-ACLR = 47.27 ± 29.32).
MAIN OUTCOME MEASURE(S)


Serum was collected before and immediately after each condition to determine sCOMPCHANGE.
INTERVENTION(S)


All participants attended 4 sessions that involved 20 minutes of walking on a force-measuring treadmill consisting of a control condition (natural loading) followed by random ordering of 3 loading conditions with real-time biofeedback: (1) symmetric vGRF between limbs, (2) a 5% increase in vGRF (high loading), and (3) a 5% decrease in vGRF (low loading),. A general linear mixed model was used to determine differences in sCOMPCHANGE between altered loading conditions and the control group in the entire cohort and the subgroup.
RESULTS


The sCOMPCHANGE was not different across loading conditions for the entire cohort (F3,29 = 1.34, P = .282). Within the subgroup, sCOMPCHANGE was less during high loading (1.95 ± 24.22 ng/mL, t21 = -3.53, P = .005) and symmetric loading (9.93 ± 21.45 ng/mL, t21 = -2.86, P = .025) compared with the control condition (25.79 ± 21.40 ng/mL).
CONCLUSIONS


Increasing peak vGRF during gait decreased sCOMP in individuals with ACLR who naturally demonstrated an increase in sCOMP after 20 minutes of walking.
TRIAL REGISTRY


ClinicalTrials.gov (NCT03035994).",2020,"The sCOMPCHANGE was not different across loading conditions for the entire cohort (F3,29 = 1.34, P = .282).","['Individuals With Anterior Cruciate Ligament Reconstruction', 'individuals with anterior cruciate ligament reconstruction (ACLR', 'Thirty individuals with unilateral ACLR participated (70% female, age = 20.43 ± 2.91 years old, body mass index = 24.42 ± 4.25, months post-ACLR = 47.83 ± 26.97', 'individuals with ACLR', 'after the control or natural loading condition (sCOMPCHANGE > 0 ng/mL, n = 22, 70% female, age = 20.32 ± 3.00 years old, body mass index = 24.73 ± 4.33, months post-ACLR = 47.27 ± 29.32']","['Gait Biofeedback', 'walking on a force-measuring treadmill consisting of a control condition (natural loading) followed by random ordering of 3 loading conditions with real-time biofeedback: (1) symmetric vGRF']","['symmetric loading', 'sCOMP', 'Immediate Biochemical Changes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]","[{'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0601900', 'cui_str': 'COMP (Cartilage Oligomeric Matrix Protein)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",30.0,0.0605497,"The sCOMPCHANGE was not different across loading conditions for the entire cohort (F3,29 = 1.34, P = .282).","[{'ForeName': 'Brittney A', 'Initials': 'BA', 'LastName': 'Luc-Harkey', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Franz', 'Affiliation': 'Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill and North Carolina State University, Raleigh.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'Department of Exercise and Sport Science, MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'J Troy', 'Initials': 'JT', 'LastName': 'Blackburn', 'Affiliation': 'Department of Exercise and Sport Science, MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Darin A', 'Initials': 'DA', 'LastName': 'Padua', 'Affiliation': 'Department of Exercise and Sport Science, MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Schwartz', 'Affiliation': 'Department of Biostatistics, MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Davis-Wilson', 'Affiliation': 'Department of Exercise and Sport Science, MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Spang', 'Affiliation': 'Department of Orthopaedics, MOTION Science Institute, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pietrosimone', 'Affiliation': 'Department of Exercise and Sport Science, MOTION Science Institute, University of North Carolina at Chapel Hill.'}]",Journal of athletic training,['10.4085/1062-6050-0372.19']
2765,32966568,A Social-Marketing Intervention and Concussion-Reporting Beliefs.,"CONTEXT


Concussion-symptom education remains the primary approach used by athletic trainers to address underreporting of possible sport-related concussions. Social marketing represents an untapped approach to promote concussion reporting by communicating the benefits or consequences of reporting or not reporting, respectively.
OBJECTIVE


To apply expectancy value theory and identify how marketing the possible consequences of concealing concussion symptoms influenced young adults' concussion-reporting beliefs to increase the likelihood of reporting.
DESIGN


Randomized controlled clinical trial.
SETTING


Laboratory.
PATIENTS OR OTHER PARTICIPANTS


A total of 468 competitive collegiate club sport athletes at a large US university who engaged in 1 of 46 sports with various levels of concussion risk.
INTERVENTION(S)


Participants were randomly assigned by team to 1 of 3 conditions. The treatment condition was a social-marketing program focused on the possible consequences of the reporting decision. The control condition was traditional concussion-symptom education based on the National Collegiate Athletic Association's publication, ""Concussion: A Fact Sheet for Student-Athletes."" An additional condition mirrored the traditional symptom education but included a less clinical delivery.
MAIN OUTCOME MEASURE(S)


Positive and negative beliefs regarding concussion reporting were assessed. We applied expectancy value theory, which posits that changing beliefs in the short term will produce greater reporting intentions in the long term.
RESULTS


Club sport athletes exposed to consequence-based social marketing showed higher levels of positive reporting beliefs and lower levels of negative reporting beliefs than athletes exposed to traditional or revised symptom education. We observed no differences between the traditional and revised symptom-education programs. Exposure to consequence-based marketing decreased negative beliefs about reporting (B = -0.165, P = .01) and increased positive beliefs about reporting (B = 0.165, P = .01).
CONCLUSIONS


Social marketing offers athletic trainers another strategic tool for motivating athletes to report concussion symptoms by translating scientific findings into marketable statements and then communicating the benefits of reporting or the negative consequences of concealing concussion symptoms.",2020,"Exposure to consequence-based marketing decreased negative beliefs about reporting (B = -0.165, P = .01) and increased positive beliefs about reporting (B = 0.165, P = .01).
","['Student-Athletes', '468 competitive collegiate club sport athletes at a large US university who engaged in 1 of 46 sports with various levels of concussion risk']",['Concussion'],['positive reporting beliefs and lower levels of negative reporting beliefs'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",468.0,0.0262032,"Exposure to consequence-based marketing decreased negative beliefs about reporting (B = -0.165, P = .01) and increased positive beliefs about reporting (B = 0.165, P = .01).
","[{'ForeName': 'Dee', 'Initials': 'D', 'LastName': 'Warmath', 'Affiliation': 'Department of Financial Planning, Housing, and Consumer Economics, College of Family and Consumer Sciences, University of Georgia, Athens.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Winterstein', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Madison.'}]",Journal of athletic training,['10.4085/1062-6050-242-19']
2766,32966683,Sperm DNA methylation changes after short-term nut supplementation in healthy males consuming a Western-style diet.,"BACKGROUND


Many environmental and lifestyle factors have been implicated in the decline of sperm quality, with diet being one of the most plausible factors identified in recent years. Moreover, several studies have reported a close association between the alteration of specific sperm DNA methylation signatures and semen quality.
OBJECTIVES


To evaluate the effect of tree nuts consumption on sperm DNA methylation patterns in healthy individuals reporting eating a Western-style diet.
MATERIAL AND METHODS


This is a post-hoc analysis conducted in a subset of participants (healthy, non-smoking, and young) from the FERTINUTS 14-wk randomized-controlled, parallel-trial, recruited between December 2015 and February 2017. The participants included in the current study (n=72) were randomly selected in a proportion 2:1 from the original FERTINUTS trial between the 98 participants that completed the entire dietary intervention (nut group, n=48; control group, n=24). Sperm DNA methylation patterns were examined at baseline and after 14 weeks in 48 individuals consuming 60 g/d of mixed nuts (nuts group) and in 24 individuals following the usual Western-style diet avoiding consumption of nuts (control group).
RESULTS


Over the course of the trial, no significant changes in global methylation were observed between groups. However, in the nuts group, we identified 36 genomic regions that were significantly differentially methylated between the baseline and the end of the trial and 97.2% of the regions displayed hypermethylation. We identified no such change in the control group over the same period of time. We also utilized the recently developed germ line age calculator to determine if nut consumption resulted in alterations to the epigenetic age of cells and no significant differences were found.
DISCUSSION AND CONCLUSION


Adding nuts to a regular Western-style diet subtly impacts sperm DNA methylation in specific regions, demonstrating that there are some sperm epigenome regions that could respond to diet.",2020,", no significant changes in global methylation were observed between groups.","['participants included in the current study (n=72) were randomly selected in a proportion 2:1 from the original FERTINUTS trial between the 98 participants that completed the entire dietary intervention (nut group, n=48; control group, n=24', 'healthy individuals reporting eating a Western-style diet', 'healthy males consuming a Western-style diet', 'participants (healthy, non-smoking, and young) from the FERTINUTS 14-wk randomized-controlled, parallel-trial, recruited between December 2015 and February 2017']","['tree nuts consumption', 'usual Western-style diet avoiding consumption of nuts (control group']",['global methylation'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C3714627', 'cui_str': 'Tree nut'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}]",72.0,0.0423172,", no significant changes in global methylation were observed between groups.","[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Salas-Huetos', 'Affiliation': 'Human Nutrition Unit, Biochemistry and Biotechnology Department, Faculty of Medicine and Health Sciences, Universitat Rovira i Virgili (URV), 43201, Reus, Spain.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'James', 'Affiliation': 'Andrology and IVF Laboratory, Division of Urology, Department of Surgery, University of Utah School of Medicine, 84108, Salt Lake City, UT, USA.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Human Nutrition Unit, Biochemistry and Biotechnology Department, Faculty of Medicine and Health Sciences, Universitat Rovira i Virgili (URV), 43201, Reus, Spain.'}, {'ForeName': 'Mònica', 'Initials': 'M', 'LastName': 'Bulló', 'Affiliation': ""Institut d'Investigació Sanitària Pere i Virgili (IISPV), 43204, Reus, Spain.""}, {'ForeName': 'Kenneth I', 'Initials': 'KI', 'LastName': 'Aston', 'Affiliation': 'Andrology and IVF Laboratory, Division of Urology, Department of Surgery, University of Utah School of Medicine, 84108, Salt Lake City, UT, USA.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Carrell', 'Affiliation': 'Andrology and IVF Laboratory, Division of Urology, Department of Surgery, University of Utah School of Medicine, 84108, Salt Lake City, UT, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Jenkins', 'Affiliation': 'Andrology and IVF Laboratory, Division of Urology, Department of Surgery, University of Utah School of Medicine, 84108, Salt Lake City, UT, USA.'}]",Andrology,['10.1111/andr.12911']
2767,32966703,"Food Structure Modulates the Bioavailability of Triglycerides and Vitamin D, and Partly that of Lutein: A Randomized Trial with a Crossover Design in Adults.","SCOPE


The specific effect of the food matrix structure on fat-soluble micronutrient bioavailability is only partly understood. We aimed at evaluating fat-soluble micronutrient bioavailability in humans after consumption of foods displaying similar composition but different structure.
METHODS AND RESULTS


Twelve healthy subjects were enrolled in a randomized, open label, crossover postprandial trial. Four different model foods were used to deliver the micronutrients: custard, pudding, sponge cake and biscuit. Vitamin D 3  , lutein and triglyceride chylomicron responses, evaluated as postprandial areas under the curve, were then assayed. Custard triglyceride response was higher than pudding and biscuit responses (up to +122.7%, p < 0.0001). Sponge cake vitamin D 3  response was higher than biscuit response (+26.6%, p = 0.047). No difference between the model foods were observed regarding lutein responses. TG responses peaked at 3h for all conditions, while vitamin D 3  and lutein peaks were delayed by 1h with the biscuit matrix compared to other model foods.
CONCLUSION


Food structure can significantly impact on triglyceride and vitamin D 3  bioavailability in terms of absorbed amounts and/or maximum absorption time. Our data also highlight positive correlations between triglyceride, vitamin D and lutein responses. These results are of particular interest to develop functional foods for population subgroups such as the elderly. This article is protected by copyright. All rights reserved.",2020,"Sponge cake vitamin D 3  response was higher than biscuit response (+26.6%, p = 0.047).","['humans after consumption of foods displaying similar composition but different structure', 'Adults', 'Twelve healthy subjects']","['Sponge cake vitamin D', 'Lutein']","['Custard triglyceride response', 'biscuit response', 'Vitamin D 3  , lutein and triglyceride chylomicron responses', 'triglyceride, vitamin D and lutein responses', 'Bioavailability of Triglycerides and Vitamin D', 'TG responses', 'lutein responses']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0452620', 'cui_str': 'Sponge cake'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}]","[{'cui': 'C0453512', 'cui_str': 'Custard'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",12.0,0.0333842,"Sponge cake vitamin D 3  response was higher than biscuit response (+26.6%, p = 0.047).","[{'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Gleize', 'Affiliation': 'INRAE, Avignon Université, UMR SQPOV, Avignon, 84914, France.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Hiolle', 'Affiliation': 'STLO, INRAE, AGROCAMPUS OUEST, Rennes, 35042, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Meunier', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Recherche en Nutrition Humaine Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'CHU Clermont-Ferrand, DRCI, Clermont-Ferrand, France.'}, {'ForeName': 'Ruddy', 'Initials': 'R', 'LastName': 'Richard', 'Affiliation': 'CHU Clermont-Ferrand, Centre de Recherche en Nutrition Humaine Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Savary-Auzeloux', 'Affiliation': 'University Clermont Auvergne, INRAE, Unité de Nutrition Humaine, UMR1019, Clermont-Ferrand, F-63000, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Buffière', 'Affiliation': 'University Clermont Auvergne, INRAE, Unité de Nutrition Humaine, UMR1019, Clermont-Ferrand, F-63000, France.'}, {'ForeName': 'Marie-Agnès', 'Initials': 'MA', 'LastName': 'Peyron', 'Affiliation': 'University Clermont Auvergne, INRAE, Unité de Nutrition Humaine, UMR1019, Clermont-Ferrand, F-63000, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Halimi', 'Affiliation': 'Aix-Marseille Univ, INRAE, INSERM, C2VN, Marseille, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Caris-Veyrat', 'Affiliation': 'INRAE, Avignon Université, UMR SQPOV, Avignon, 84914, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Nau', 'Affiliation': 'STLO, INRAE, AGROCAMPUS OUEST, Rennes, 35042, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Reboul', 'Affiliation': 'Aix-Marseille Univ, INRAE, INSERM, C2VN, Marseille, France.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000228']
2768,32966714,Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes.,"BACKGROUND


The cardiovascular effects of ertugliflozin, an inhibitor of sodium-glucose cotransporter 2, have not been established.
METHODS


In a multicenter, double-blind trial, we randomly assigned patients with type 2 diabetes and atherosclerotic cardiovascular disease to receive 5 mg or 15 mg of ertugliflozin or placebo once daily. With the data from the two ertugliflozin dose groups pooled for analysis, the primary objective was to show the noninferiority of ertugliflozin to placebo with respect to the primary outcome, major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). The noninferiority margin was 1.3 (upper boundary of a 95.6% confidence interval for the hazard ratio [ertugliflozin vs. placebo] for major adverse cardiovascular events). The first key secondary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure.
RESULTS


A total of 8246 patients underwent randomization and were followed for a mean of 3.5 years. Among 8238 patients who received at least one dose of ertugliflozin or placebo, a major adverse cardiovascular event occurred in 653 of 5493 patients (11.9%) in the ertugliflozin group and in 327 of 2745 patients (11.9%) in the placebo group (hazard ratio, 0.97; 95.6% confidence interval [CI], 0.85 to 1.11; P<0.001 for noninferiority). Death from cardiovascular causes or hospitalization for heart failure occurred in 444 of 5499 patients (8.1%) in the ertugliflozin group and in 250 of 2747 patients (9.1%) in the placebo group (hazard ratio, 0.88; 95.8% CI, 0.75 to 1.03; P = 0.11 for superiority). The hazard ratio for death from cardiovascular causes was 0.92 (95.8% CI, 0.77 to 1.11), and the hazard ratio for death from renal causes, renal replacement therapy, or doubling of the serum creatinine level was 0.81 (95.8% CI, 0.63 to 1.04). Amputations were performed in 54 patients (2.0%) who received the 5-mg dose of ertugliflozin and in 57 patients (2.1%) who received the 15-mg dose, as compared with 45 patients (1.6%) who received placebo.
CONCLUSIONS


Among patients with type 2 diabetes and atherosclerotic cardiovascular disease, ertugliflozin was noninferior to placebo with respect to major adverse cardiovascular events. (Funded by Merck Sharp & Dohme and Pfizer; VERTIS CV ClinicalTrials.gov number, NCT01986881.).",2020,The hazard ratio for death from cardiovascular causes was 0.92,"['Type 2 Diabetes', 'patients with type 2 diabetes and atherosclerotic cardiovascular disease to', '8238 patients who received at least one dose of', 'patients with type 2 diabetes and atherosclerotic cardiovascular disease', '8246 patients underwent randomization and were followed for a mean of 3.5 years']","['Ertugliflozin', 'ertugliflozin vs. placebo', 'placebo', 'receive 5 mg or 15 mg of ertugliflozin or placebo', 'ertugliflozin or placebo', 'ertugliflozin']","['hazard ratio for death from cardiovascular causes', 'Cardiovascular Outcomes', 'Amputations', 'adverse cardiovascular event', 'composite of death from cardiovascular causes or hospitalization for heart failure', 'major adverse cardiovascular events (a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke', 'hazard ratio for death from renal causes, renal replacement therapy, or doubling of the serum creatinine level', 'Death from cardiovascular causes or hospitalization for heart failure']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}]",8246.0,0.755502,The hazard ratio for death from cardiovascular causes was 0.92,"[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pratley', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mancuso', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Masiukiewicz', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Charbonnel', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Frederich', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Silvina', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cosentino', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Weichung J', 'Initials': 'WJ', 'LastName': 'Shih', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': ""From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (C.P.C.); AdventHealth Translational Research Institute, Orlando, FL (R.P.); the University of Tennessee Health Science Center, Memphis (S.D.-J.); Pfizer, Groton, CT (J.M., U.M., R.F., S.G.T.); Merck, Kenilworth, NJ (S.H., I.G.); the Department of Endocrinology, University of Nantes, Nantes, France (B.C.); Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey, New Brunswick (W.J.S.); Pfizer, Berlin (S.G.); the Unit of Cardiology, Karolinska Institute and Karolinska University Hospital, Stockholm (F.C.); the University of Toronto, Toronto (D.Z.I.C); and the University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004967']
2769,32969200,Modulation of gut mucosal microbiota as a mechanism of probiotics-based adjunctive therapy for ulcerative colitis.,"This was a pilot study aiming to evaluate the effects of probiotics as adjunctive treatment for ulcerative colitis (UC). Twenty-five active patients with UC were assigned to the probiotic (n = 12) and placebo (n = 13) groups. The probiotic group received mesalazine (60 mg kg -1   day -1  ) and oral probiotics (containing Lactobacillus casei Zhang, Lactobacillus plantarum P-8 and Bifidobacterium animalis subsp. lactis V9) twice daily for 12 weeks, while the placebo group received the same amounts of mesalazine and placebo. The clinical outcomes were assessed. The gut mucosal microbiota was profiled by PacBio single-molecule, real-time (SMRT) sequencing of the full-length 16S rRNA of biopsy samples obtained by colonoscopy. A significantly greater magnitude of reduction was observed in the UC disease activity index (UCDAI) in the probiotic group compared with the placebo group (P = 0.043), accompanying by a higher remission rate (91.67% for probiotic-receivers versus 69.23% for placebo-receivers, P = 0.034). The probiotics could protect from diminishing of the microbiota diversity and richness. Moreover, the gut mucosal microbiota of the probiotic-receivers had significantly more beneficial bacteria like Eubacterium ramulus (P < 0.05), Pediococcus pentosaceus (P < 0.05), Bacteroides fragilis (P = 0.02) and Weissella cibaria (P = 0.04). Additionally, the relative abundances of the beneficial bacteria correlated significantly but negatively with the UCDAI score, suggesting that the probiotics might alleviate UC symptoms by modulating the gut mucosal microbiota. Our research has provided new insights into the mechanism of symptom alleviation in UC by applying probiotic-based adjunctive treatment.",2020,"A significantly greater magnitude of reduction was observed in the UC disease activity index (UCDAI) in the probiotic group compared with the placebo group (P = 0.043), accompanying by a higher remission rate (91.67% for probiotic-receivers versus 69.23% for placebo-receivers, P = 0.034).","['Twenty-five active patients with UC', 'ulcerative colitis (UC', 'ulcerative colitis']","['mesalazine and placebo', 'probiotics', 'oral probiotics (containing Lactobacillus casei Zhang, Lactobacillus plantarum P-8 and Bifidobacterium animalis subsp', 'placebo', 'probiotics-based adjunctive therapy', 'mesalazine']","['Pediococcus pentosaceus', 'Bacteroides fragilis', 'Weissella cibaria', 'gut mucosal microbiota', 'UC disease activity index (UCDAI', 'remission rate', 'beneficial bacteria like Eubacterium ramulus']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0445656', 'cui_str': 'Pediococcus pentosaceus'}, {'cui': 'C1066567', 'cui_str': 'Weissella cibaria'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0317500', 'cui_str': 'Eubacterium ramulus'}]",25.0,0.0533351,"A significantly greater magnitude of reduction was observed in the UC disease activity index (UCDAI) in the probiotic group compared with the placebo group (P = 0.043), accompanying by a higher remission rate (91.67% for probiotic-receivers versus 69.23% for placebo-receivers, P = 0.034).","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'Feiyan', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'Chengcong', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'Lai-Yu', 'Initials': 'LY', 'LastName': 'Kwok', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Cong', 'Affiliation': 'The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'YanFang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'Wenyi', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}, {'ForeName': 'XiaoFeng', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, 100029, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education P. R. C., Key Laboratory of Dairy Products Processing, Ministry of Agriculture and Rural Affairs P. R. C., Inner Mongolia Agricultural University, Hohhot, 010018, China.'}]",Microbial biotechnology,['10.1111/1751-7915.13661']
2770,32969262,Effect of a Workplace Weight-Loss Program for Overweight and Obese Healthcare Workers.,"PURPOSE


Examining the effect of a workplace weight-loss program on weight loss, and physical, behavioral and mental well-being among overweight/obese healthcare workers.
DESIGN


Quasi experimental design.
SETTING


Single healthcare setting.
PARTICIPANTS


Forty-one (48.0 ± 11.2 years) day-time shift healthcare employees with body mass index [BMI] >29 kg/m 2 .
INTERVENTION


Sixteen-week program with weekly group meetings/activities and individual appointments with nutrition/health experts.
MEASURES


Objective (weight, BMI, blood pressure) and self-reported measures were collected at baseline, conclusion of the intervention and 3 to 6 months post-intervention.
ANALYSIS


Repeated measure analysis accounting for confounders.
RESULTS


Participants had an average of 13 pounds (5.6%) weight loss (224.2 ± 6.4 vs. 211.6 ± 6.4 lbs.;  P  < 0.0001) upon program completion with significant decreases in BMI (37.7 ± 1.0 vs. 35.1 ± 1.0 kg/m 2 ;  P  < 0.0001). Extreme obesity (BMI≥40 kg/m 2 ) rate was reduced from 36.6% to 17.1% ( P  < 0.0001). There were decreases in diastolic blood pressure (76.0 ± 1.4 vs. 68.7 ± 1.5 mmHg;  P  = 0.001) and self-reported blood glucose (119.9 ± 4.4 vs. 105.5 ± 4.6 mg/dL;  P  = 0.03). Participants had improvements in weekly physical activity (25% change;  P  = 0.01), nutrition behavior (33% change,  P  < 0.0001), sleep quality (23% change,  P  = 0.005), and depression (72% change,  P  < 0.0001). Twenty-seven participants had post-intervention follow-up data. On average participants regained 8 pounds, which was less than the initial weight loss (16 lbs., N = 27).
CONCLUSION


The results suggest the program may benefit healthcare employees. Further emphasis should be placed on post-intervention weight management to prevent weight regain.",2020,"Participants had improvements in weekly physical activity (25% change;  P  = 0.01), nutrition behavior (33% change,  P  < 0.0001), sleep quality (23% change,  P  = 0.005), and depression (72% change,  P  < 0.0001).","['Overweight and Obese Healthcare Workers', 'Single healthcare setting', 'overweight/obese healthcare workers', 'Participants had an average of 13 pounds (5.6%) weight loss (224.2 ± 6.4 vs. 211.6 ± 6.4 lbs', 'Twenty-seven participants had post-intervention follow-up data', 'Forty-one (48.0 ± 11.2 years) day-time shift healthcare employees with body mass index']","['Workplace Weight-Loss Program', 'workplace weight-loss program', 'Sixteen-week program with weekly group meetings/activities and individual appointments with nutrition/health experts']","['BMI', 'initial weight loss', 'nutrition behavior', 'self-reported blood glucose', 'weekly physical activity', 'weight loss, and physical, behavioral and mental well-being', 'Extreme obesity (BMI≥40 kg/m 2 ) rate', 'sleep quality', 'depression', 'Objective (weight, BMI, blood pressure) and self-reported measures', 'diastolic blood pressure']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439511', 'cui_str': 'times/day'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.0256968,"Participants had improvements in weekly physical activity (25% change;  P  = 0.01), nutrition behavior (33% change,  P  < 0.0001), sleep quality (23% change,  P  = 0.005), and depression (72% change,  P  < 0.0001).","[{'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Nepper', 'Affiliation': '6217Nebraska Methodist Health System, Omaha, NE, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'McAtee', 'Affiliation': 'Department of Nutrition and Health Sciences, 14719University of Nebraska-Lincoln, Lincoln, NE, USA.'}, {'ForeName': 'Weiwen', 'Initials': 'W', 'LastName': 'Chai', 'Affiliation': 'Department of Nutrition and Health Sciences, 14719University of Nebraska-Lincoln, Lincoln, NE, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120960393']
2771,32969330,"'I have the confidence to ask' : thickening agency among adolescent girls in Karnataka, South India.","Gender norms serve to normalise gender inequalities and constrain girls' agency. This paper examines how girls' agency, along a continuum, is influenced by the interplay between constraining and enabling influences in the girls' environments. We analyse data from a qualitative study nested within a cluster randomised evaluation of  Samata , a multi-layered programme supporting adolescent girls to stay in school and delay marriage in Karnataka, South India. Specifically, we compare agency among 22 girls from intervention communities and 9 girls in control communities using data from the final round of interviews in a qualitative cohort. Using the concept of 'thin' and 'thick' agency on a continuum, we identified shocks like mothers' death or illness, poverty stress, gender norms and poor school performance as thinning influences. Good school examination results; norms in support of education; established educational aspirations; supportive parents, siblings and teachers; and strategic government and  Samata  resources enabled thicker agency. The intervention programme's effect increased in parallel to the gradient from thin to thicker agency among girls in progressively supportive family contexts. Engagement with the programme was however selective; families adhering to harmful gender norms were not receptive to outreach. In line with diffusion theory, late adopters required additional peer encouragement to change norms.",2020,The intervention programme's effect increased in parallel to the gradient from thin to thicker agency among girls in progressively supportive family contexts.,"['22 girls from intervention communities and 9 girls in control communities using data from the final round of interviews in a qualitative cohort', 'supporting adolescent girls to stay in school and delay marriage in Karnataka, South India', 'adolescent girls in Karnataka, South India']",['multi-layered programme'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}]",[],22.0,0.0279346,The intervention programme's effect increased in parallel to the gradient from thin to thicker agency among girls in progressively supportive family contexts.,"[{'ForeName': 'Satyanarayana', 'Initials': 'S', 'LastName': 'Ramanaik', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), IT Park, Bangalore, India.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Collumbien', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Pujar', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), IT Park, Bangalore, India.'}, {'ForeName': 'Lottie', 'Initials': 'L', 'LastName': 'Howard-Merrill', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'Beniamino', 'Initials': 'B', 'LastName': 'Cislaghi', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Prakash', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), IT Park, Bangalore, India.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Javalkar', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), IT Park, Bangalore, India.'}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Thalinja', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), IT Park, Bangalore, India.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Beattie', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Moses', 'Affiliation': 'Center for Global Public Health, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Shajy', 'Initials': 'S', 'LastName': 'Isac', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), IT Park, Bangalore, India.'}, {'ForeName': 'Mitzy', 'Initials': 'M', 'LastName': 'Gafos', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'Parinita', 'Initials': 'P', 'LastName': 'Bhattacharjee', 'Affiliation': 'Center for Global Public Health, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Heise', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins Bloomberg School of Public Health and Johns Hopkins University School of Nursing, Baltimore, MD, USA.'}]","Culture, health & sexuality",['10.1080/13691058.2020.1812118']
2772,32969384,Comparative Study of Slow Infusion versus Bolus Doses of Albumin and Furosemide Infusion to Mobilize Refractory Ascites in Decompensated Chronic Liver Disease.,"BACKGROUND


Combined use of furosemide with albumin is an approved therapy to overcome diuretic resistance in treatment of ascites in decompensated chronic liver disease. Bolus dosing of diuretics has its own limitations due to pre-existing hypotension, post diuretic sodium retention and braking phenomenon. Slow albumin and furosemide Infusion has been shown to mobilize large ascites with improved diuresis and hemodynamic stability in decompensated chronic liver disease. This study was undertaken to compare efficacy and safety of infusion therapy vs bolus therapy in term the management of refractory ascites.
METHODS


Decompensated chronic liver disease patients with refractory ascites were randomly assigned into two groups of 15 each - Bolus therapy (intravenous albumin and furosemide as boluses) and Infusion therapy (furosemide infusion at 2mg/hour and albumin at 2g/hour for three days). Diuresis, natriuresis, change in abdominal girth and body weight, and hemodynamic stability (change in SBP) were compared between the two groups.
RESULTS


Infusion therapy, as compared to bolus therapy, showed a significantly better diuresis (mean urinary output increment 483ml vs 243ml, p <0.001), natriuresis (mean urinary sodium excretion increment 35.2 mEq/L vs 16.6 mEq/L, p = 0.004),decrease in abdominal circumference (6.1cm vs 3.0cm, p<0.001) and decrease in body weight (5.53 Kg vs 2.86 Kg, p < 0.001). The complications of renal impairment were also lower in the Infusion group.
CONCLUSION


Infusion of furosemide and albumin is a potential safer and effective therapeutic option in the management of refractory ascites with better natriuresis, higher urine output, and higher decrement in abdominal circumference and body weight, and lesser side effects.",2020,"RESULTS


Infusion therapy, as compared to bolus therapy, showed a significantly better diuresis (mean urinary output increment 483ml vs 243ml, p <0.001), natriuresis (mean urinary sodium excretion increment 35.2 mEq/L vs 16.6 mEq/L, p = 0.004),decrease in abdominal circumference (6.1cm vs 3.0cm, p<0.001) and decrease in body weight (5.53 Kg vs 2.86 Kg, p < 0.001).","['decompensated chronic liver disease', 'Decompensated chronic liver disease patients with refractory ascites', 'Decompensated Chronic Liver Disease']","['Albumin and Furosemide Infusion', 'Slow albumin and furosemide Infusion', 'furosemide with albumin', 'Bolus therapy (intravenous albumin and furosemide as boluses) and Infusion therapy (furosemide infusion at 2mg/hour and albumin', 'furosemide and albumin', 'diuretics', 'Slow Infusion']","['Diuresis, natriuresis, change in abdominal girth and body weight, and hemodynamic stability (change in SBP', 'abdominal circumference', 'diuresis', 'efficacy and safety', 'abdominal circumference and body weight', 'complications of renal impairment', 'body weight', 'natriuresis (mean urinary sodium excretion']","[{'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3532188', 'cui_str': 'Refractory ascites'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}]","[{'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0027477', 'cui_str': 'Natriuresis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.0514268,"RESULTS


Infusion therapy, as compared to bolus therapy, showed a significantly better diuresis (mean urinary output increment 483ml vs 243ml, p <0.001), natriuresis (mean urinary sodium excretion increment 35.2 mEq/L vs 16.6 mEq/L, p = 0.004),decrease in abdominal circumference (6.1cm vs 3.0cm, p<0.001) and decrease in body weight (5.53 Kg vs 2.86 Kg, p < 0.001).","[{'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Pathak', 'Affiliation': 'Department of Gastroenterology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu.'}, {'ForeName': 'Ajay Kumar', 'Initials': 'AK', 'LastName': 'Yadav', 'Affiliation': 'Department of Internal Medicine, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Thapaliya', 'Affiliation': 'Department of Internal Medicine, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Brindeshwari', 'Initials': 'B', 'LastName': 'Kafle', 'Affiliation': 'Department of Gastroenterology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu.'}, {'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Jha', 'Affiliation': 'Department of Gastroenterology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Khadga', 'Affiliation': 'Department of Gastroenterology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu.'}]",Journal of Nepal Health Research Council,['10.33314/jnhrc.v18i2.2116']
2773,31368759,Experimental manipulation of extraverted and introverted behavior and its effects on well-being.,"Research in personality psychology has remained predominantly correlational. For example, 3 decades of research demonstrate a robust cross-sectional relationship between extraversion and positive affect. A handful of studies, however, have examined this link experimentally, showing that extraversion boosts positive affect over short durations. If this is true, behaving in an extraverted manner should be a reliable method for increasing positive affect and, thus, suitable as a well-being-increasing practice. The current study instructed participants to engage in both extraverted and introverted behavior, each for 1 week. Participants increased in well-being when they were assigned to act extraverted and decreased in well-being when they were assigned to act introverted. These findings suggest that changing behavior associated with personality is possible and can impact well-being. More broadly, this study adds to a growing body of research on the potential of experimental methods in personality psychology. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,Participants increased in well-being when they were assigned to act extraverted and decreased in well-being when they were assigned to act introverted.,[],[],[],[],[],[],,0.0233797,Participants increased in well-being when they were assigned to act extraverted and decreased in well-being when they were assigned to act introverted.,"[{'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Margolis', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Lyubomirsky', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. General,['10.1037/xge0000668']
2774,31972826,Postactivation Potentiation in Blood Flow-Restricted Complex Training.,"Cleary, CJ and Cook, SB. Postactivation potentiation in blood flow-restricted complex training. J Strength Cond Res 34(4): 905-910, 2020-Complex training uses a high-load (HL) resistance exercise to elicit postactivation potentiation (PAP) that is typically observed through enhanced plyometric performance. Blood flow-restricted (BFR) resistance exercise uses low loads to induce similar muscular adaptations to HL resistance exercise; however, the efficacy and feasibility of BFR complex training are unknown. Fifteen college-aged men (mean ± SD; age: 20.3 ± 0.9 years; relative back-squat one-repetition maximum [1RM]: 1.78 ± 0.3 kg·kg) with at least 2 years of resistance training experience completed 3 sessions: a familiarization session with 1RM testing, and 2 complex training sessions of 3 presquat vertical jumps (VJs), condition-specific back squats (HL: 5 repetitions at 85% 1RM, BFR: 30 repetitions at 30% 1RM), and a single postsquat VJ. Postactivation potentiation was calculated as (postsquat VJ height ÷ max presquat VJ height) [BULLET OPERATOR] 100. Electromyography (EMG) of the vastus lateralis and hamstrings was collected, quantified to root mean square values, and normalized to peak 1RM activity. Postsquat VJ height was significantly reduced in both conditions, and PAP did not occur because it was less than 100% (HL: 96.1 ± 5.1%, BFR: 90.8 ± 7.8%, p = 0.010). Vastus lateralis and hamstrings EMG amplitude was highest (p < 0.001) in the HL condition. High-load and BFR complex training decreased subsequent VJ height in these individuals, and this might have been due to an ineffective complex training protocol and individual factors such as training status and relative strength.",2020,Vastus lateralis and hamstrings EMG amplitude was highest (p < 0.001) in the HL condition.,"['Res 34(4', 'Fifteen college-aged men (mean ± SD; age: 20.3 ± 0.9 years; relative back-squat one-repetition maximum [1RM]: 1.78 ± 0.3 kg·kg) with at least 2 years of resistance training experience completed 3 sessions: a']","['High-load and BFR complex training', 'familiarization session with 1RM testing, and 2 complex training sessions of 3 presquat vertical jumps (VJs), condition-specific back squats (HL: 5 repetitions at 85% 1RM, BFR: 30 repetitions at 30% 1RM', '2020-Complex training uses a high-load (HL) resistance exercise to elicit postactivation potentiation (PAP', 'Blood flow-restricted (BFR) resistance exercise', 'J Strength Cond']","['Postactivation potentiation', 'Cleary, CJ and Cook, SB', 'subsequent VJ height', 'Postsquat VJ height', 'Electromyography (EMG) of the vastus lateralis and hamstrings', 'Vastus lateralis and hamstrings EMG amplitude']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}]",,0.0130733,Vastus lateralis and hamstrings EMG amplitude was highest (p < 0.001) in the HL condition.,"[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cleary', 'Affiliation': 'Robert Kertzer Exercise Physiology Laboratory, Department of Kinesiology, Durham, New Hampshire.'}, {'ForeName': 'Summer B', 'Initials': 'SB', 'LastName': 'Cook', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003497']
2775,31977000,The protein C activator AB002 rapidly interrupts thrombus development in baboons.,"Although thrombin is a key enzyme in the coagulation cascade and is required for both normal hemostasis and pathologic thrombogenesis, it also participates in its own negative feedback via activation of protein C, which downregulates thrombin generation by enzymatically inactivating factors Va and VIIIa. Our group and others have previously shown that thrombin's procoagulant and anticoagulant activities can be effectively disassociated to varying extents through site-directed mutagenesis. The thrombin mutant W215A/E217A (WE thrombin) has been one of the best characterized constructs with selective activity toward protein C. Although animal studies have demonstrated that WE thrombin acts as an anticoagulant through activated protein C (APC) generation, the observed limited systemic anticoagulation does not fully explain the antithrombotic potency of this or other thrombin mutants. AB002 (E-WE thrombin) is an investigational protein C activator thrombin analog in phase 2 clinical development (clinicaltrials.gov NCT03963895). Here, we demonstrate that this molecule is a potent enzyme that is able to rapidly interrupt arterial-type thrombus propagation at exceedingly low doses (<2 µg/kg, IV), yet without substantial systemic anticoagulation in baboons. We demonstrate that AB002 produces APC on platelet aggregates and competitively inhibits thrombin-activatable fibrinolysis inhibitor (carboxypeptidase B2) activation in vitro, which may contribute to the observed in vivo efficacy. We also describe its safety and activity in a phase 1 first-in-human clinical trial. Together, these results support further clinical evaluation of AB002 as a potentially safe and effective new approach for treating or preventing acute thrombotic and thromboembolic conditions. This trial was registered at www.clinicaltrials.gov as #NCT03453060.",2020,"The thrombin mutant W215A/E217A (WE thrombin) has been one of the best characterized constructs with selective activity toward protein C. Although animal studies have demonstrated that WE thrombin acts as an anticoagulant through activated protein C (APC) generation, the observed limited systemic anticoagulation does not fully explain the antithrombotic potency of this or other thrombin mutants.",[],"['thrombin', 'AB002 ', 'E-WE thrombin']",['safety and activity'],[],"[{'cui': 'C0040018', 'cui_str': 'Thrombin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0455567,"The thrombin mutant W215A/E217A (WE thrombin) has been one of the best characterized constructs with selective activity toward protein C. Although animal studies have demonstrated that WE thrombin acts as an anticoagulant through activated protein C (APC) generation, the observed limited systemic anticoagulation does not fully explain the antithrombotic potency of this or other thrombin mutants.","[{'ForeName': 'Erik I', 'Initials': 'EI', 'LastName': 'Tucker', 'Affiliation': 'Aronora, Inc, Portland, OR.'}, {'ForeName': 'Norah G', 'Initials': 'NG', 'LastName': 'Verbout', 'Affiliation': 'Aronora, Inc, Portland, OR.'}, {'ForeName': 'Brandon D', 'Initials': 'BD', 'LastName': 'Markway', 'Affiliation': 'Aronora, Inc, Portland, OR.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wallisch', 'Affiliation': 'Aronora, Inc, Portland, OR.'}, {'ForeName': 'Christina U', 'Initials': 'CU', 'LastName': 'Lorentz', 'Affiliation': 'Aronora, Inc, Portland, OR.'}, {'ForeName': 'Monica T', 'Initials': 'MT', 'LastName': 'Hinds', 'Affiliation': 'Department of Biomedical Engineering and.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Shatzel', 'Affiliation': 'Department of Biomedical Engineering and.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Pelc', 'Affiliation': 'Department of Biochemistry and Molecular Biology, School of Medicine, Saint Louis University, St. Louis, MO.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wood', 'Affiliation': 'Department of Biochemistry and Molecular Biology, School of Medicine, Saint Louis University, St. Louis, MO.'}, {'ForeName': 'Owen J T', 'Initials': 'OJT', 'LastName': 'McCarty', 'Affiliation': 'Department of Biomedical Engineering and.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Di Cera', 'Affiliation': 'Department of Biochemistry and Molecular Biology, School of Medicine, Saint Louis University, St. Louis, MO.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Gruber', 'Affiliation': 'Aronora, Inc, Portland, OR.'}]",Blood,['10.1182/blood.2019002771']
2776,32045911,Late Neurological Deterioration after Acute Intracerebral Hemorrhage: A post hoc Analysis of the ATACH-2 Trial.,"BACKGROUND


Neurological deterioration (ND) has a major influence on the prognosis of intracerebral hemorrhage (ICH); however, factors associated with ND occurring after 24 h of ICH onset are unknown.
METHODS


We performed exploratory analyses of data from the Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 trial, which compared intensive and standard blood pressure lowering treatment in ICH. NDs were captured on the adverse event case report form. Logistic regression analysis was performed to examine the independent predictors of late ND.
RESULTS


Among 1,000 participants with acute ICH, 82 patients (8.2%) developed early ND (≤24 h), and 64 (6.4%) had late ND. Baseline hematoma volume (adjusted OR [aOR] per 1-cm3 increase 1.04, 95% CI 1.02-1.06, p < 0.0001), hematoma volume increase in 24 h (aOR 2.24, 95% CI 1.23-4.07, p = 0.008), and the presence of intraventricular hemorrhage (IVH; aOR 2.38, 95% CI 1.32-4.29, p = 0.004) were independent predictors of late ND (vs. no late ND). Late ND was a significant risk factor for poor 90-day outcome (OR 3.46, 95% CI 1.82-6.56). No statistically significant difference in the incidence of late ND was noted between the 2 treatment groups.
CONCLUSIONS


Initial hematoma volume, early hematoma volume expansion, and IVH are independent predictors of late ND after ICH. Intensive reduction in the systolic blood pressure level does not prevent the development of late ND.",2020,"Baseline hematoma volume (adjusted OR [aOR] per 1-cm3 increase 1.04, 95% CI 1.02-1.06, p < 0.0001), hematoma volume increase in 24 h (aOR 2.24, 95% CI 1.23-4.07, p = 0.008), and the presence of intraventricular hemorrhage (IVH; aOR 2.38, 95% CI 1.32-4.29, p = 0.004) were independent predictors of late ND (vs. no late ND).","['1,000 participants with acute ICH, 82 patients (8.2%) developed early ND (≤24 h), and 64 (6.4%) had late ND', 'Acute Intracerebral Hemorrhage']",[],"['incidence of late ND', 'Late Neurological Deterioration', 'systolic blood pressure level', 'hematoma volume increase', 'Baseline hematoma volume', 'presence of intraventricular hemorrhage']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}]",1000.0,0.118604,"Baseline hematoma volume (adjusted OR [aOR] per 1-cm3 increase 1.04, 95% CI 1.02-1.06, p < 0.0001), hematoma volume increase in 24 h (aOR 2.24, 95% CI 1.23-4.07, p = 0.008), and the presence of intraventricular hemorrhage (IVH; aOR 2.38, 95% CI 1.32-4.29, p = 0.004) were independent predictors of late ND (vs. no late ND).","[{'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Okazaki', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan, s-okazaki@umin.ac.jp.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Fukuda-Doi', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ihara', 'Affiliation': 'Department of Neurology, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, Missouri, USA.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506117']
2777,32974974,The impact of occlusive versus non-occlusive application of 5-aminolaevulinic acid (BF-200 ALA) on the efficacy and tolerability of photodynamic therapy for actinic keratosis on the scalp and face: a prospective within-patient comparison trial.,"BACKGROUND


Photodynamic therapy (PDT) is an effective treatment for actinic keratoses (AK). PDT is usually performed with occlusion of the photosensitizer prior to subsequent illumination. This study aimed to compare the efficacy and tolerability of occlusive versus non-occlusive application of a 5-aminolaevulinic gel (BT-200 ALA) for PDT of multiple AK on the scalp or face.
METHODS


Prospective, investigator-blinded, within-patient comparison study on 45 patients. PDT with occlusion of ALA was performed in a target area on one randomized side of the scalp or face. One week later a contralateral target area received the same treatment except that no occlusion of the ALA gel was performed. 3 and 6 months after PDT the clearance rate of a predetermined target lesion and the total clearance rate of all AK within the treated areas were determined. PDT-induced pain and skin phototoxicity and cosmetic outcome were also recorded.
RESULTS


Clearance rate of the target AK and total AK clearance rate at 3 months after PDT was 88.4% and 90.6% for occlusive PDT and 58.1% (p = 0.001) and 70.4% (p = 0.04) for non-occlusive PDT. The corresponding values at 6 months after PDT were 69.7% and 72.1% for occlusive PDT and 30.2% (p < 0.001) and 35.6% (p = 0.001) for non-occlusive PDT. Pain score and skin phototoxicity were significantly higher after occlusive ALA application. No difference was observed with respect to cosmetic outcome.
CONCLUSION


Occlusive application of ALA significantly improves the efficacy of PDT but is associated with more pain and increased phototoxicity.",2020,"No difference was observed with respect to cosmetic outcome.
","['actinic keratoses (AK', 'actinic keratosis on the scalp and face', '45 patients']","['PDT with occlusion of ALA', 'Photodynamic therapy (PDT', '5-aminolaevulinic gel (BT-200 ALA', 'photodynamic therapy', '5-aminolaevulinic acid (BF-200 ALA']","['pain and increased phototoxicity', 'clearance rate of a predetermined target lesion and the total clearance rate', 'Pain score and skin phototoxicity', 'PDT-induced pain and skin phototoxicity and cosmetic outcome', 'efficacy and tolerability', 'cosmetic outcome', 'Clearance rate of the target AK and total AK clearance rate']","[{'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C3490787', 'cui_str': 'BF-200 ALA'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162830', 'cui_str': 'Phototoxic dermatitis'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}]",45.0,0.0397044,"No difference was observed with respect to cosmetic outcome.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Meierhofer', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Silic', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Urban', 'Affiliation': 'Trauma Hospital Klagenfurt, Klagenfurt am Wörthersee, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tanew', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Radakovic', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Vienna, Austria.'}]","Photodermatology, photoimmunology & photomedicine",['10.1111/phpp.12613']
2778,32975020,Does a physical therapist-administered physical activity intervention reduce sedentary time after total knee replacement: An exploratory study?,,2020,,['total knee replacement'],['physical therapist-administered physical activity intervention'],[],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0172209,,"[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Coleman', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'White', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Thoma', 'Affiliation': 'Division of Physical Therapy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Mathews', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Meredith B', 'Initials': 'MB', 'LastName': 'Christiansen', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Schmitt', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Jakiela', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}, {'ForeName': 'Hiral', 'Initials': 'H', 'LastName': 'Master', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, Delaware, USA.'}]",Musculoskeletal care,['10.1002/msc.1517']
2779,32966573,Immunogenicity of a Live-Attenuated Dengue Vaccine Using a Heterologous Prime-Boost Strategy in a Phase I Randomized Clinical Trial.,"BACKGROUND


Dengue is a global health problem, and the development of a tetravalent dengue vaccine with durable protection is a high priority. A heterologous prime boost strategy has the advantage of eliciting immune responses through different mechanisms and therefore may be superior to homologous prime boost strategies for generating durable tetravalent immunity.
METHODS


In this phase 1 first in human heterologous prime boost study, 80 volunteers were assigned to 4 groups and received a tetravalent dengue virus (DENV-1-4) purified inactivated vaccine (TDENV-PIV) with alum adjuvant and a tetravalent dengue virus (DENV-1-4) live attenuated vaccine (TDENV-LAV) in different orders and dosing schedules (28 or 180 days apart).
RESULTS


All vaccination regimens had acceptable safety profiles, and there were no vaccine-related serious adverse events. TDEN-PIV followed by TDEN-LAV induced higher neutralizing antibody titers and a higher rate of tetravalent seroconversions compared to TDEN-LAV followed by TDEN-PIV. Both TDEN-PIV followed by TDEN-LAV groups demonstrated 100% tetravalent seroconversion 28 days following the booster dose which was maintained for most of these subjects through the day 180 measurement.
CONCLUSION


A heterologous prime-boost vaccination strategy for dengue merits additional evaluation for safety, immunogenicity, and potential for clinical benefit.(Trial Registered at ClinicalTrials.gov: NCT02239614).",2020,TDEN-PIV followed by TDEN-LAV induced higher neutralizing antibody titers and a higher rate of tetravalent seroconversions compared to TDEN-LAV followed by TDEN-PIV.,['80 volunteers'],"['Live-Attenuated Dengue Vaccine', 'tetravalent dengue virus (DENV-1-4) purified inactivated vaccine (TDENV-PIV) with alum adjuvant and a tetravalent dengue virus (DENV-1-4) live attenuated vaccine (TDENV-LAV']","['Immunogenicity', 'neutralizing antibody titers']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C0011315', 'cui_str': 'Dengue virus'}, {'cui': 'C0011313', 'cui_str': 'Dengue virus, type 1'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",80.0,0.241263,TDEN-PIV followed by TDEN-LAV induced higher neutralizing antibody titers and a higher rate of tetravalent seroconversions compared to TDEN-LAV followed by TDEN-PIV.,"[{'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Koren', 'Affiliation': 'Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD.'}, {'ForeName': 'Kristopher M', 'Initials': 'KM', 'LastName': 'Paolino', 'Affiliation': 'Clinical Trials Center, Walter Reed Army Institute of Research, Silver Spring, MD.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Pilot Bioproduction Facility, Walter Reed Army Institute of Research, Silver Spring, MD.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'De La Barrera', 'Affiliation': 'Pilot Bioproduction Facility, Walter Reed Army Institute of Research, Silver Spring, MD.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Currier', 'Affiliation': 'Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Gromowski', 'Affiliation': 'Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD.'}, {'ForeName': 'Naomi E', 'Initials': 'NE', 'LastName': 'Aronson', 'Affiliation': 'Uniformed Services University of the Health Sciences, Bethesda, MD.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Keiser', 'Affiliation': 'Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD.'}, {'ForeName': 'Marvin J', 'Initials': 'MJ', 'LastName': 'Sklar', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Sondergaard', 'Affiliation': 'Clinical Trials Center, Walter Reed Army Institute of Research, Silver Spring, MD.'}, {'ForeName': 'Louis E', 'Initials': 'LE', 'LastName': 'Jasper', 'Affiliation': 'U.S. Army Medical Materiel Development Activity (USAMMDA), Frederick, MD.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Endy', 'Affiliation': 'SUNY Upstate Medical University, Institute for Global Health and Translational Sciences, Syracuse, NY.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jarman', 'Affiliation': 'Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa603']
2780,32966574,"RBX7455, a Room Temperature-Stable, Orally-Administered Investigational Live Biotherapeutic, is Safe, Effective, and Shifts Patients' Microbiomes in a Phase 1 Study for Recurrent Clostridioides difficile Infections.","BACKGROUND


Recurrent Clostridioides difficile infections (rCDI) are a global public health threat. To reduce rCDI, microbiota-restoring therapies are needed, particularly standardized, easy-to-administer formulations.
METHODS


This Phase I open-label trial assessed the safety, efficacy in preventing rCDI recurrence, and intestinal microbiome effects of RBX7455, a room temperature-stable, orally administered investigational live biotherapeutic. Adult participants with one or more prior episodes of rCDI received: four RBX7455 capsules twice daily for four days (Group 1); four RBX7455 capsules twice daily for two days (Group 2); or two RBX7455 capsules twice daily for two days (Group 3). For all groups, the first dose was administered in clinic, with remaining doses self-administered at home. Adverse events were monitored during and for 6 months after treatment. Treatment success was defined as rCDI prevention through 8 weeks after treatment. Participants' microbiome composition was assessed prior to and for 6 months after treatment.
RESULTS


Nine of 10 Group 1 patients (90%), 8 of 10 Group 2 patients (80%), and 10 of 10 Group 3 patients (100%) were recurrence-free at the 8-week endpoint with durability to 6 months. Seventy-five treatment-emergent adverse events were observed in 27 participants with no serious investigational product-related events. Prior to treatment, participants' microbiomes were dissimilar from the RBX7455 composition with decreased Bacteroidia- and Clostridia-class bacteria, whereas after treatment, responders' microbiomes showed increased Bacteroidia and Clostridia.
CONCLUSIONS


Three dosing regimens of RBX7455 were safe and effective at preventing rCDI. Responders' microbiomes converged toward the composition of RBX7455. These results support its continued clinical evaluation.
CLINICAL TRIALS REGISTRATION


NCT02981316.",2020,"Prior to treatment, participants' microbiomes were dissimilar from the RBX7455 composition with decreased Bacteroidia- and Clostridia-class bacteria, whereas after treatment, responders' microbiomes showed increased Bacteroidia and Clostridia.
","['Adult participants with one or more prior episodes of rCDI received: four', '27 participants with no serious investigational product-related events']","['RBX7455 capsules', 'RBX7455']","['Adverse events', 'Bacteroidia and Clostridia', 'recurrence-free', 'RBX7455 composition with decreased Bacteroidia- and Clostridia-class bacteria']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1634514', 'cui_str': 'Class Bacteroidia'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",,0.029679,"Prior to treatment, participants' microbiomes were dissimilar from the RBX7455 composition with decreased Bacteroidia- and Clostridia-class bacteria, whereas after treatment, responders' microbiomes showed increased Bacteroidia and Clostridia.
","[{'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Khanna', 'Affiliation': 'Division of Gastroenterology and Hepatology Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Darrell S', 'Initials': 'DS', 'LastName': 'Pardi', 'Affiliation': 'Division of Gastroenterology and Hepatology Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Rebiotix Inc, a Ferring Company, Roseville, MN, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Shannon', 'Affiliation': 'BioRankings LLC, St. Louis, MO, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gonzalez', 'Affiliation': 'Division of Gastroenterology and Hepatology Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Blount', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1430']
2781,32966585,"Nighttime Agitation and Restless Legs Syndrome in Persons With Alzheimer's Disease: Study Protocol for a Double-Blind, Placebo-Controlled, Randomized Trial (NightRest).","Nighttime agitation is a prevalent symptom in persons with Alzheimer's disease (AD). Effective treatments are absent due to our limited knowledge of its etiology. We hypothesized that restless legs syndrome (RLS), a common neurological sensorimotor disorder of uncomfortable leg sensations that appear at night and interfere with sleep, might be a cause for nighttime agitation in persons with AD. RLS is infrequently identified in persons with AD because traditional diagnosis is dependent on patients answering complex questions about their symptoms. With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of gabapentin enacarbil (GEn) compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects. We hypothesize that frequency of RLS behaviors will mediate the relationship between GEn and nighttime agitation. This study is an 8-week, double-blind, placebo-controlled, randomized pilot clinical trial, followed by an 8-week open-label trial, that is being conducted in long-term care settings and private homes. The results of this study may shift, personalize, and improve standards of care for treatment of nighttime agitation; reduce aggression and other nighttime agitation behaviors; and improve sleep.
TARGETS


Persons with AD with nighttime agitation potentially caused by RLS.
INTERVENTION DESCRIPTION


Diagnose RLS and determine the effect of GEn.
MECHANISMS OF ACTION


The frequency of RLS behaviors will mediate the relationship between GEn and nighttime agitation.
OUTCOMES


Determine the effect of GEn on nighttime agitation, sleep, and antipsychotic medications.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03082755 (Date of registration March 6, 2017). [Research in Gerontological Nursing, xx(x), xx-xx.].",2020,"With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of gabapentin enacarbil (GEn) compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects.","[""Persons With Alzheimer's Disease"", 'Persons with AD with nighttime agitation potentially caused by RLS', 'persons with AD', ""persons with Alzheimer's disease (AD""]","['placebo', 'GEn', 'Placebo', 'gabapentin enacarbil (GEn']","['Nighttime Agitation and Restless Legs Syndrome', 'nighttime agitation, sleep, and antipsychotic medications', 'Nighttime agitation', 'nighttime agitation, sleep, antipsychotic medications']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2700226', 'cui_str': 'Gabapentin enacarbil'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.449575,"With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of gabapentin enacarbil (GEn) compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects.","[{'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Richards', 'Affiliation': ''}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Rangel', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Loera', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hanlon', 'Affiliation': ''}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Lozano', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kovach', 'Affiliation': ''}, {'ForeName': 'Nalaka', 'Initials': 'N', 'LastName': 'Gooneratne', 'Affiliation': ''}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Fry', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Allen', 'Affiliation': ''}]",Research in gerontological nursing,['10.3928/19404921-20200918-01']
2782,32966587,The effect of mannitol on oxidation-reduction potential in patients undergoing deceased donor renal transplantation - A randomized controlled trial.,"BACKGROUND


Mannitol, an osmotic diuretic, is proposed to be an oxygen radical scavenger. Mannitol is often used in renal transplantation to attenuate oxidative stress and thus to protect renal graft function. We tested the hypothesis that mannitol reduces overall oxidative stress during deceased donor renal transplantation.
METHODS


We randomly assigned 34 patients undergoing deceased donor renal transplantation to receive a solution of mannitol or placebo shortly before graft reperfusion until the end of surgery. We evaluated oxidative stress by measuring the static oxidative-reduction potential (sORP) and the capacity of the oxidative-reduction potential (cORP). sORP and cORP were measured preoperatively, before and within 10 minutes after graft reperfusion, and postoperatively.
RESULTS


17 patients were enrolled in the mannitol group and 17 patients were enrolled in the placebo group. Mannitol had no significant effect on sORP (148.5 mV [136.2; 160.2]) as compared to placebo (143.6 mV [135.8; 163.2], p = 0.99). There was also no significant difference in cORP between the mannitol (0.22µC [0.16; 0.36]) and the placebo group (0.22 µC [0.17; 0.38], P = 0.76).
CONCLUSION


Mannitol showed no systemic redox scavenging effects during deceased donor renal transplantation. To evaluate the direct effect of mannitol on the renal graft further studies are needed.",2020,"There was also no significant difference in cORP between the mannitol (0.22µC [0.16; 0.36]) and the placebo group (0.22 µC [0.17; 0.38], P = 0.76).
","['34 patients undergoing deceased donor renal transplantation to receive a', '17 patients were enrolled in the mannitol group and 17 patients were enrolled in the placebo group', 'patients undergoing deceased donor renal transplantation ', 'deceased donor renal transplantation']","['mannitol', 'placebo', 'solution of mannitol or placebo', 'Mannitol']","['systemic redox scavenging effects', 'sORP and cORP', 'overall oxidative stress', 'cORP', 'sORP', 'static oxidative-reduction potential (sORP) and the capacity of the oxidative-reduction potential (cORP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0730392', 'cui_str': 'Donor renal transplantation'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",34.0,0.381711,"There was also no significant difference in cORP between the mannitol (0.22µC [0.16; 0.36]) and the placebo group (0.22 µC [0.17; 0.38], P = 0.76).
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reiterer', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Clinical Department of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Sljivic', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Falkner von Sonnenburg', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kabon', 'Affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13713']
2783,32966603,Video-Enhanced Care Management for Medically Complex Older Adults with Cognitive Impairment.,"OBJECTIVE


This pilot study assessed feasibility of video-enhanced care management for complex older veterans with suspected mild cognitive impairment (CI) and their care partners, compared with telephone delivery.
DESIGN


Pilot randomized controlled trial.
SETTING


Durham Veterans Affairs Health Care System.
PARTICIPANTS


Participants were enrolled as dyads, consisting of veterans aged 65 years or older with complex medical conditions (Care Assessment Need score ≥90) and suspected mild CI (education-adjusted Modified Telephone Interview for Cognitive Status score 20-31) and their care partners.
INTERVENTION


The 12-week care management intervention consisted of monthly calls from a study nurse covering medication management, cardiovascular disease risk reduction, physical activity, and sleep behaviors, delivered via video compared with telephone.
MEASUREMENTS


Dyads completed baseline and follow-up assessments to assess feasibility, acceptability, and usability.
RESULTS


Forty veterans (mean (standard deviation (SD)) age = 72.4 (6.1) years; 100% male; 37.5% Black) and their care partners (mean (SD) age = 64.7 (10.8) years) were enrolled and randomized to telephone or video-enhanced care management. About a third of veteran participants indicated familiarity with relevant technology (regular tablet use and/or experience with videoconferencing); 53.6% of internet users were comfortable or very comfortable using the internet. Overall, 43 (71.7%) care management calls were completed in the video arm and 52 (86.7%) were completed in the telephone arm. Usability of the video telehealth platform was rated higher for participants already familiar with technology used to deliver the intervention (mean (SD) System Usability Scale scores: 65.0 (17.0) vs 55.6 (19.6)). Veterans, care partners, and study nurses reported greater engagement, communication, and interaction in the video arm.
CONCLUSION


Video-delivered care management calls were feasible and preferred over telephone for some complex older adults with mild CI and their care partners. Future research should focus on understanding how to assess and incorporate patient and family preferences related to uptake and maintenance of video telehealth interventions.",2020,Usability of the video telehealth platform was rated higher for participants already familiar with technology used to deliver the intervention (mean (SD) System Usability Scale scores: 65.0 (17.0) vs 55.6 (19.6)).,"['Forty veterans (mean (standard deviation (SD)) age = 72.4 (6.1) years; 100% male; 37.5% Black) and their care partners (mean (SD) age = 64.7 (10.8) years', 'Medically Complex Older Adults with Cognitive Impairment', 'Participants were enrolled as dyads, consisting of veterans aged 65\u2009years or older with complex medical conditions (Care Assessment Need score ≥90) and suspected mild CI (education-adjusted Modified Telephone Interview for Cognitive Status score 20-31) and their care partners', 'complex older adults with mild CI and their care partners', 'complex older veterans with suspected mild cognitive impairment (CI) and their care partners', 'Durham Veterans Affairs Health Care System']","['care management intervention consisted of monthly calls from a study nurse covering medication management, cardiovascular disease risk reduction, physical activity, and sleep behaviors, delivered via video compared with telephone', 'Video-Enhanced Care Management', 'video-enhanced care management', 'telephone or video-enhanced care management', 'Video-delivered care management calls were feasible and preferred over telephone']","['feasibility, acceptability, and usability']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0454851', 'cui_str': 'Durham'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0735304,Usability of the video telehealth platform was rated higher for participants already familiar with technology used to deliver the intervention (mean (SD) System Usability Scale scores: 65.0 (17.0) vs 55.6 (19.6)).,"[{'ForeName': 'Susan N', 'Initials': 'SN', 'LastName': 'Hastings', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Mahanna', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Theodore S Z', 'Initials': 'TSZ', 'LastName': 'Berkowitz', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Smith', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Choate', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Jaime M', 'Initials': 'JM', 'LastName': 'Hughes', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Juliessa', 'Initials': 'J', 'LastName': 'Pavon', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Katina', 'Initials': 'K', 'LastName': 'Robinson', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hendrix', 'Affiliation': 'Center for the Study of Human Aging and Development, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Van Houtven', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Gentry', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Rose', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Plassman', 'Affiliation': 'Center for the Study of Human Aging and Development, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Potter', 'Affiliation': 'Department of Psychiatry, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Oddone', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, North Carolina, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16819']
2784,32966722,"Lower-Dose Zinc for Childhood Diarrhea - A Randomized, Multicenter Trial.","BACKGROUND


The World Health Organization recommends 20 mg of zinc per day for 10 to 14 days for children with acute diarrhea; in previous trials, this dosage decreased diarrhea but increased vomiting.
METHODS


We randomly assigned 4500 children in India and Tanzania who were 6 to 59 months of age and had acute diarrhea to receive 5 mg, 10 mg, or 20 mg of zinc sulfate for 14 days. The three primary outcomes were a diarrhea duration of more than 5 days and the number of stools (assessed in a noninferiority analysis) and the occurrence of vomiting (assessed in a superiority analysis) within 30 minutes after zinc administration.
RESULTS


The percentage of children with diarrhea for more than 5 days was 6.5% in the 20-mg group, 7.7% in the 10-mg group, and 7.2% in the 5-mg group. The difference between the 20-mg and 10-mg groups was 1.2 percentage points (upper boundary of the 98.75% confidence interval [CI], 3.3), and that between the 20-mg and 5-mg groups was 0.7 percentage points (upper boundary of the 98.75% CI, 2.8), both of which were below the noninferiority margin of 4 percentage points. The mean number of diarrheal stools was 10.7 in the 20-mg group, 10.9 in the 10-mg group, and 10.8 in 5-mg group. The difference between the 20-mg and 10-mg groups was 0.3 stools (upper boundary of the 98.75% CI, 1.0), and that between the 20-mg and 5-mg groups was 0.1 stools (upper boundary of the 98.75% CI, 0.8), both of which were below the noninferiority margin (2 stools). Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86). Lower doses were also associated with less vomiting beyond 30 minutes after administration.
CONCLUSIONS


Lower doses of zinc had noninferior efficacy for the treatment of diarrhea in children and were associated with less vomiting than the standard 20-mg dose. (Funded by the Bill and Melinda Gates Foundation; ZTDT ClinicalTrials.gov number, NCT03078842.).",2020,"Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86).","['children with acute diarrhea', '4500 children in India and Tanzania who were 6 to 59 months of age and had acute diarrhea', 'Childhood Diarrhea ']",['zinc sulfate'],"['percentage of children with diarrhea', 'Vomiting', 'occurrence of vomiting', 'diarrhea duration of more than 5 days and the number of stools', 'mean number of diarrheal stools', 'vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C4517780', 'cui_str': '4500'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0444858', 'cui_str': 'AM 6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",4500.0,0.0686028,"Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86).","[{'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Dhingra', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Rodrick', 'Initials': 'R', 'LastName': 'Kisenge', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Dhingra', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Somji', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bakari', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Saikat', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Prabhabati', 'Initials': 'P', 'LastName': 'Devi', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Enju', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Chauhan', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Om P', 'Initials': 'OP', 'LastName': 'Semwal', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sazawal', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Manji', 'Affiliation': ""From the Center for Public Health Kinetics, New Delhi, India (U.D., P. Dhingra, A.D., S.D., P. Devi, A.C., J.K., O.P.S., S. Sazawal); Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (R.K., S. Somji, M.B., S.A., K.M.); Harvard T.H. Chan School of Public Health (C.R.S., C.P.D.) and Boston Children's Hospital (E.L., C.P.D.), Boston; and the World Health Organization, Geneva (R.B., P.A., J.S.).""}]",The New England journal of medicine,['10.1056/NEJMoa1915905']
2785,32966755,Aprepitant For Cough in Lung Cancer: A Randomised Placebo-Controlled Trial and Mechanistic Insights.,"RATIONALE


Effective cough treatments are a significant unmet need in lung cancer patients. Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of Neurokinin 1 (NK-1) receptors, a mechanism also implicated in cough.
OBJECTIVE


To assess aprepitant in lung cancer patients with cough and evaluate mechanisms in vagal nerve tissue.
METHODS


Randomised double-blind crossover trial of lung cancer patients with bothersome cough. They received three days of aprepitant or matched placebo; following a three day wash out, patients crossed to the alternative treatment. The primary endpoint was awake cough frequency measured at screening and day 3 of each treatment; secondary endpoints included patient-reported outcomes. In vitro, the depolarization of isolated guinea pig and human vagus nerve sections in grease gap recording chambers, indicative of sensory nerve activation, was measured to evaluate mechanism.
MEASUREMENTS AND MAIN RESULTS


Twenty lung cancer patients enrolled, mean age 66years (±7.7), 60% female, 80% non-small cell cancer, 50% advanced stage and 55% WHO performance status 1. Cough frequency improved with aprepitant, reducing by 22.2%(95%CI 2.8-37.7%) over placebo whilst awake (p=0.03), 30.3%(95%CI 12.7-44.3) over 24hours (p=0.002) and 59.8%(95%CI 15.1-86.0) during sleep (p=0.081). Patient-reported outcomes all significantly improved. Substance P depolarised both guinea pig and human vagus nerve. Aprepitant significantly inhibited substance P induced depolarisation by 78% in guinea pig (p=0.0145) and 94% in human vagus (p=0.0145).
DISCUSSION


Substance P activation of NK-1 receptors appears to be an important mechanism driving cough in lung cancer, and NK-1 antagonists show promise as anti-tussive therapies. Clinical trial registration available at www.http://www.isrctn.com/, ID: ISRCTN16200035.",2020,"Aprepitant significantly inhibited substance P induced depolarisation by 78% in guinea pig (p=0.0145) and 94% in human vagus (p=0.0145).
","['Lung Cancer', 'lung cancer patients with cough', 'lung cancer patients with bothersome cough', 'lung cancer patients', 'Twenty lung cancer patients enrolled, mean age 66years (±7.7), 60% female, 80% non-small cell cancer, 50% advanced stage and 55% WHO performance status 1']","['aprepitant or matched placebo', 'placebo', 'Placebo']","['substance P induced depolarisation', 'nausea and vomiting', 'awake cough frequency', 'Cough frequency']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",20.0,0.460251,"Aprepitant significantly inhibited substance P induced depolarisation by 78% in guinea pig (p=0.0145) and 94% in human vagus (p=0.0145).
","[{'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'The University of Manchester Faculty of Biology Medicine and Health, 12203, Division of Infection, Immunity and Respiratory Medicine, Manchester, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Harle', 'Affiliation': 'The University of Manchester, 5292, Division of Molecular & Clinical Cancer Sciences, Manchester, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dockry', 'Affiliation': 'The University of Manchester, 5292, Division of Infection, Immunity and Respiratory Medicine, Manchester, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'The University of Manchester, 5292, Division of Infection, Immunity and Respiratory Medicine, Manchester, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Russell', 'Affiliation': 'The Christie NHS Foundation Trust, 5294, Manchester, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Molassiotis', 'Affiliation': 'The Hong Kong Polytechnic University, 26680, School of Nursing, Kowloon, Hong Kong.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Yorke', 'Affiliation': 'The University of Manchester, 5292, Division of Nursing, Midwifery & Social Work, Manchester, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Robinson', 'Affiliation': 'Imperial College London, 4615, Respiratory Pharmacology, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Birrell', 'Affiliation': 'Imperial College London, 4615, Respiratory Pharmacology, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Belvisi', 'Affiliation': 'Imperial College London, 4615, Respiratory Pharmacology, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Blackhall', 'Affiliation': 'The University of Manchester, 5292, Division of Molecular & Clinical Cancer Sciences, Manchester, United Kingdom of Great Britain and Northern Ireland.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202006-2359OC']
2786,32966810,"Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND


Surufatinib showed superior efficacy in extrapancreatic neuroendocrine tumours (NETs) in the phase 3 SANET-ep study. In SANET-p, we aimed to assess the efficacy and safety of surufatinib in patients with advanced pancreatic NETs.
METHODS


SANET-p was a multicentre, randomised, double-blind, placebo-controlled, phase 3 study, done in 21 hospitals across China. Eligible patients were adults (aged 18 years or older) with progressive, advanced, well differentiated pancreatic NETs, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and progression on up to two kinds of previous systemic regimens for advanced disease. Patients were randomly assigned (2:1) via an interactive web response system to receive 300 mg of surufatinib or placebo, taken orally once per day in consecutive 4-week treatment cycles until disease progression, intolerable toxicity, withdrawal of consent, poor compliance, use of other antitumour medication, pregnancy, loss to follow-up, or if the investigator deemed discontinuation in the patient's best interest. Randomisation was done centrally using stratified block randomisation (block size three), stratified by pathological grade, previous systemic antitumour treatment, and ECOG performance status score. Patients, investigators, research staff, and the sponsor study team were masked to treatment allocation. Crossover to surufatinib was permitted for patients in the placebo group with disease progression. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population, which included all patients in randomisation. A pre-planned interim analysis was done at 70% of the predicted progression-free survival events. This study is registered at ClinicalTrials.gov, NCT02589821.
FINDINGS


Between Feb 18, 2016, and Nov 11, 2019, of 264 patients who were screened, 172 (65%) patients were randomly assigned to receive surufatinib (n=113) or placebo (n=59). The median follow-up was 19·3 months (95% CI 9·3-19·4) in the surufatinib group and 11·1 months (5·7-35·9) in the placebo group. The median investigator-assessed progression-free survival was 10·9 months (7·5-13·8) for surufatinib versus 3·7 months (2·8-5·6) for placebo (hazard ratio 0·49, 95% CI 0·32-0·76; p=0·0011). The trial met the early stopping criteria at the interim analysis and was terminated on recommendation from the independent data monitoring committee. The most common grade 3 or worse treatment-related adverse events were hypertension (43 [38%] of 113 with surufatinib vs four [7%] of 59 with placebo), proteinuria (11 [10%] vs one [2%]), and hypertriglyceridaemia (eight [7%] vs none). Treatment-related serious adverse events were reported in 25 (22%) patients in the surufatinib group and four (7%) patients in the placebo group. There were three on-treatment deaths in the surufatinib group, including two deaths due to adverse events (gastrointestinal haemorrhage [possibly treatment-related] and cerebral haemorrhage [unlikely to be treatment-related]), and one death attributed to disease progression. One on-treatment death in the placebo group was attributed to disease progression.
INTERPRETATION


Surufatinib significantly improves progression-free survival and has an acceptable safety profile in patients with progressive, advanced pancreatic NETs, and could be a potential treatment option in this patient population.
FUNDING


Hutchison MediPharma.",2020,The median investigator-assessed progression-free survival was 10·9 months (7·5-13·8) for surufatinib versus 3·7 months (2·8-5·6) for placebo (hazard ratio,"['patients with advanced pancreatic NETs', '21 hospitals across China', 'Between Feb 18, 2016, and Nov 11, 2019, of 264 patients who were screened, 172 (65%) patients', 'advanced pancreatic neuroendocrine tumours (SANET-p', 'Eligible patients were adults (aged 18 years or older) with progressive, advanced, well differentiated pancreatic NETs, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and progression on up to two kinds of previous systemic regimens for advanced disease', 'group with disease progression', 'patients with progressive, advanced pancreatic NETs']","['interactive web response system to receive 300 mg of surufatinib or placebo', 'surufatinib', 'placebo']","['hypertriglyceridaemia', 'proteinuria', 'adverse events (gastrointestinal haemorrhage', 'disease progression', 'efficacy and safety', 'median investigator-assessed progression-free survival', 'cerebral haemorrhage', 'treatment deaths', 'progression-free survival', 'serious adverse events', 'investigator-assessed progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0242363', 'cui_str': 'Pancreatic endocrine tumor'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.710105,The median investigator-assessed progression-free survival was 10·9 months (7·5-13·8) for surufatinib versus 3·7 months (2·8-5·6) for placebo (hazard ratio,"[{'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China. Electronic address: jmxu2003@yahoo.com.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Xianjun', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Abdominal Oncology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Enxiao', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yihebali', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'National Cancer Center and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': 'Department of General Surgery, Zhongshan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Dianrong', 'Initials': 'D', 'LastName': 'Xiu', 'Affiliation': 'Department of General Surgery, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""People's Liberation Army Cancer Center of Nanjing Jinling Hospital, Nanjing, China.""}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Yuejuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Clinical and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Clinical and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Clinical and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30493-9']
2787,32966811,"Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND


Therapeutic options for advanced neuroendocrine tumours (NETs) are limited. We investigated the efficacy and safety of surufatinib (HMPL-012, sulfatinib) in patients with extrapancreatic NETs.
METHODS


SANET-ep was a randomised, double-blind, placebo-controlled, phase 3 trial undertaken at 24 hospitals across China. Patients (aged 18 years or older) with unresectable or metastatic, well differentiated, extrapancreatic NETs, with an Eastern Cooperative Oncology Group performance status of 0 or 1, and progression on no more than two types of previous systemic regimens were enrolled. Patients were centrally randomly assigned (2:1) using stratified block randomisation (block size 3) via an interactive web response system to receive oral surufatinib at 300 mg per day or matching placebo. Randomisation was stratified by tumour origin, pathological grade, and previous treatment. Patients, investigators, research staff and the sponsor study team were masked to treatment allocation. Crossover to the surufatinib group was allowed for patients in the placebo group at disease progression. The primary endpoint was investigator-assessed progression-free survival, which was analysed in the intention-to-treat population. A preplanned interim analysis was done at 70% of predicted progression-free survival events. This study was registered with ClinicalTrials.gov, NCT02588170. Follow-up is ongoing.
FINDINGS


Between Dec 9, 2015, and March 31, 2019, 198 patients were randomly assigned to surufatinib (n=129) or placebo (n=69). Median follow-up was 13·8 months (95% CI 11·1-16·7) in the surufatinib group and 16·6 months (9·2-not calculable) in the placebo group. Investigator-assessed median progression-free survival was 9·2 months (95% CI 7·4-11·1) in the surufatinib group versus 3·8 months (3·7-5·7) in the placebo group (hazard ratio 0·33; 95% CI 0·22-0·50; p<0·0001). As the trial met the predefined criteria for early discontinuation of the study at the interim analysis, the study was terminated early, as recommended by the independent data monitoring committee. The most common treatment-related adverse events of grade 3 or worse were hypertension (47 [36%] of 129 patients in the surufatinib group vs nine [13%] of 68 patients in the placebo group) and proteinuria (25 [19%] vs zero). Treatment-related serious adverse events were reported in 32 (25%) of 129 patients in the surufatinib group and nine (13%) of 68 patients in the placebo group. Treatment-related deaths occurred in three patients in the surufatinib group (disseminated intravascular coagulation and hepatic encephalopathy, liver injury, and death with unknown reason) and one patient in the placebo group (cachexia and respiratory failure).
INTERPRETATION


Progression-free survival was significantly longer in patients given surufatinib compared with patients given placebo, and surufatinib has a favourable benefit-to-risk profile in patients with progressive, advanced, well differentiated extrapancreatic NETs. Our results suggest that surufatinib might be a new treatment option for this population.
FUNDING


Hutchison MediPharma.",2020,Treatment-related serious adverse events were reported in 32 (25%) of 129 patients in the surufatinib group and nine (13%) of 68 patients in the placebo group.,"['advanced extrapancreatic neuroendocrine tumours (SANET-ep', '24 hospitals across China', 'patients with extrapancreatic NETs', 'advanced neuroendocrine tumours (NETs', 'Patients (aged 18 years or older) with unresectable or metastatic, well differentiated, extrapancreatic NETs, with an Eastern Cooperative Oncology Group performance status of 0 or 1, and progression on no more than two types of previous systemic regimens were enrolled', '198 patients were randomly assigned to surufatinib (n=129) or', 'Between Dec 9, 2015, and March 31, 2019']","['placebo', 'surufatinib (HMPL-012, sulfatinib', 'stratified block randomisation (block size 3) via an interactive web response system to receive oral surufatinib at 300 mg per day or matching placebo']","['progression-free survival events', 'Progression-free survival', 'deaths', 'Investigator-assessed median progression-free survival', 'hypertension', 'serious adverse events', 'investigator-assessed progression-free survival']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",198.0,0.726932,Treatment-related serious adverse events were reported in 32 (25%) of 129 patients in the surufatinib group and nine (13%) of 68 patients in the placebo group.,"[{'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China. Electronic address: jmxu2003@yahoo.com.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yihebali', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Abdominal Oncology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Enxiao', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': ""Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Zhongshan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Xingya', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Jieer', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': 'Department of Abdominal Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xianjun', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""People's Liberation Army Cancer Center of Nanjing Jinling Hospital, Nanjing, China.""}, {'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Oncology, The Sixth Affiliated Hospital, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases l, Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Dianrong', 'Initials': 'D', 'LastName': 'Xiu', 'Affiliation': 'Department of General Surgery, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Thoracic Oncology, Jilin Provincial Cancer Hospital, Changchun, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Development and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Department of Clinical Development and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Department of Clinical Development and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Clinical Development and Regulatory Affairs, Hutchison MediPharma, Shanghai, China.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30496-4']
2788,32967068,Effect of Vitamin D Supplement on Vulvovaginal Atrophy of the Menopause.,"The effects of oral vitamin D supplements on vaginal health in postmenopausal women with vulvovaginal atrophy (VVA) was evaluated. A double-blinded, randomized placebo-controlled trial was conducted for 12 weeks to investigate changes on vaginal maturation index (VMI), vaginal pH, and the visual analog scale (VAS) of VVA symptoms. The vitamin D group received oral ergocalciferol, at 40,000 IU per week, while the placebo group received an identical placebo capsule. Eighty postmenopausal women were enrolled. There were no significant differences in baseline characteristics between both groups. In an intention-to-treat analysis, VMI, vaginal pH, and VAS of VVA symptoms showed no significant differences between both groups at the six and 12 weeks. However, the mean difference of VMI in the vitamin D group between baseline and at six weeks showed significant improvement (5.5 + 16.27,  p  <0.05). Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline. The oral vitamin D supplementation for 12 weeks potentially improves vaginal health outcomes in postmenopausal women with VVA symptoms, demonstrated by the improved mean VMI, vaginal pH, and VAS at six and 12 weeks between baseline, however, no significant differences were observed from the placebo treatment.",2020,"Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline.","['Eighty postmenopausal women were enrolled', 'postmenopausal women with vulvovaginal atrophy (VVA', 'postmenopausal women with VVA symptoms']","['oral ergocalciferol', 'Vitamin D Supplement', 'vitamin D', 'oral vitamin D supplements', 'placebo capsule', 'placebo', 'oral vitamin D supplementation']","['VMI, vaginal pH, and VAS of VVA symptoms', 'vaginal health', 'Vulvovaginal Atrophy of the Menopause', 'mean VMI, vaginal pH, and VAS', 'vaginal health outcomes', 'VMI', 'mean vaginal pH and VAS', 'vaginal maturation index (VMI), vaginal pH, and the visual analog scale (VAS) of VVA symptoms']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0857741', 'cui_str': 'Vulvovaginal atrophy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",80.0,0.39508,"Moreover, the mean vaginal pH and VAS of VVA patients in the vitamin D group were significantly improved at both six and 12 weeks compared to baseline.","[{'ForeName': 'Thawinee', 'Initials': 'T', 'LastName': 'Kamronrithisorn', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Manonai', 'Affiliation': 'Female Pelvic Medicine and Reconstructive Surgery Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Sakda Arj-Ong', 'Initials': 'SA', 'LastName': 'Vallibhakara', 'Affiliation': 'ASEAN Institute for Health Development, Mahidol University, Nakhon Pathom 73170, Thailand.'}, {'ForeName': 'Areepan', 'Initials': 'A', 'LastName': 'Sophonsritsuk', 'Affiliation': 'Reproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}, {'ForeName': 'Orawin', 'Initials': 'O', 'LastName': 'Vallibhakara', 'Affiliation': 'Reproductive Endocrinology and Infertility Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand.'}]",Nutrients,['10.3390/nu12092876']
2789,32967132,Vitamin D Correction Down-Regulates Serum Amyloid P Component Levels in Vitamin D Deficient Arab Adults: A Single-Arm Trial.,"Vitamin D (VD) has been observed to have anti-inflammatory properties. However, the effects of VD supplementation on the serum amyloid P component (SAP) has not been established. This study aimed to investigate the effect of VD supplementation on serum SAP levels in Arab adults. A total of 155 VD-deficient adult Saudis (56 males and 99 females) were recruited in this non-randomized, 6-month, single-arm trial. The intervention was as follows; cholecalciferol 50,000 international units (IU) every week for the first 2 months, followed by 50,000 twice a month for the next two months, and for the last two months, 1000 IU daily. Serum 25(OH)D, SAP, C-reactive protein (CRP), lipid profile, and glucose were assessed at baseline and post-intervention. At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants. Remarkably, this reduction in SAP was more significant in males than females after stratification. SAP was inversely correlated with VD overall (r = -0.17,  p  < 0.05), and only in males (r = -0.27,  p  < 0.05) after stratification according to sex after 6 months of VD supplementation. Such a relationship was not observed at baseline. VD supplementation can favorably modulate serum SAP concentrations in Arab adults, particularly in males.",2020,"At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants.","['A total of 155 VD-deficient adult Saudis (56 males and 99 females', 'Vitamin D Deficient Arab Adults', 'Arab adults, particularly in males', 'Arab adults']","['VD supplementation', 'Vitamin D Correction Down', 'Vitamin D (VD', 'cholecalciferol']","['SAP', 'serum SAP levels', 'VD levels', 'SAP levels', 'serum SAP concentrations', 'Serum 25(OH)D, SAP, C-reactive protein (CRP), lipid profile, and glucose']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0282540', 'cui_str': 'Arabs'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0002721', 'cui_str': 'Amyloid P component'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.0318965,"At post-intervention, VD levels were significantly increased, while SAP levels significantly decreased in all study participants.","[{'ForeName': 'Osama E', 'Initials': 'OE', 'LastName': 'Amer', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Malak N K', 'Initials': 'MNK', 'LastName': 'Khattak', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Alnaami', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}, {'ForeName': 'Naji J', 'Initials': 'NJ', 'LastName': 'Aljohani', 'Affiliation': 'Specialized Diabetes and Endocrine Center, King Fahad Medical City, Riyadh 11525, Saudi Arabia.'}, {'ForeName': 'Nasser M', 'Initials': 'NM', 'LastName': 'Al-Daghri', 'Affiliation': 'Biochemistry Department, College of Science, King Saud University, Riyadh 11451, Saudi Arabia.'}]",Nutrients,['10.3390/nu12092880']
2790,32967151,"Effects of  Tetraselmis chuii  Microalgae Supplementation on Ergospirometric, Haematological and Biochemical Parameters in Amateur Soccer Players.","This study aimed to analyse the effects of  Tetraselmis chuii  (TC) microalgae supplementation during thirty days on ergospirometric, haematological and biochemical parameters in amateur soccer players. Thirty-two amateur soccer players divided into a control group (CG;  n  = 16; 22.36 ± 1.36 years; 68.36 ± 3.53 kg) and a supplemented group (SG;  n  = 16; 22.23 ± 2.19 years; 69.30 ± 5.56 kg) participated in the double-blind study. SG ingested 200 mg of the TC per day, while CG ingested 200 mg per day of lactose powder. Supplementation was carried out for thirty days. The participants performed a maximal treadmill test until exhaustion. The ergospirometric values at different ventilatory thresholds and haematological values were obtained after the test. Heart rate decreased after supplementation with TC ( p  < 0.05). Oxygen pulse, relative and absolute maximum oxygen consumption increased in SG (pre vs. post; 19.04 ± 2.53 vs. 22.08 ± 2.25; 53.56 ± 3.26 vs. 56.74 ± 3.43; 3.72 ± 0.35 vs. 3.99 ± 0.25;  p  < 0.05). Haemoglobin and mean corpuscular haemoglobin increased in SG (pre vs. post; 15.12 ± 0.87 vs. 16.58 ± 0.74  p  < 0.01; 28.03 ± 1.57 vs. 30.82 ± 1.21;  p  < 0.05). On the other hand, haematocrit and mean platelet volume decreased in SG ( p  < 0.05). TC supplementation elicited improvements in ergospirometric and haematological values in amateur soccer players. TC supplementation could be valuable for improving performance in amateur athletes.",2020,Haemoglobin and mean corpuscular haemoglobin increased in SG (pre vs. post; 15.12 ± 0.87 vs. 16.58 ± 0.74  p  < 0.01; 28.03 ± 1.57 vs. 30.82 ± 1.21;  p  < 0.05).,"['Amateur Soccer Players', 'amateur athletes', 'Thirty-two amateur soccer players divided into a control group (CG;  n  = 16; 22.36 ± 1.36 years; 68.36 ± 3.53 kg) and a supplemented group (SG;  n  = 16; 22.23 ± 2.19 years; 69.30 ± 5.56 kg) participated in the double-blind study', 'amateur soccer players']","['Tetraselmis chuii  (TC) microalgae supplementation', 'TC supplementation', 'Tetraselmis chuii  Microalgae Supplementation']","['Oxygen pulse, relative and absolute maximum oxygen consumption', 'haematocrit and mean platelet volume', 'Heart rate', 'Haemoglobin and mean corpuscular haemoglobin', 'Ergospirometric, Haematological and Biochemical Parameters', 'ergospirometric and haematological values']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4708912', 'cui_str': '1.36'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517793', 'cui_str': '5.56'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C2936330', 'cui_str': 'Microphytes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0200665', 'cui_str': 'Platelet mean volume determination'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0369183', 'cui_str': 'Mean corpuscular hemoglobin determination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0954851,Haemoglobin and mean corpuscular haemoglobin increased in SG (pre vs. post; 15.12 ± 0.87 vs. 16.58 ± 0.74  p  < 0.01; 28.03 ± 1.57 vs. 30.82 ± 1.21;  p  < 0.05).,"[{'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Robles-Gil', 'Affiliation': 'Department of Didactics of Musical, Plastic and Corporal Expression, School of Teacher Training, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rodrigo', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Department of Physiology, School of Sport Sciences, University of Extremadura, University Avenue, s/n CP: 10003 Cáceres, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186885']
2791,32967160,Non-Immersive Virtual Reality for Post-Stroke Upper Extremity Rehabilitation: A Small Cohort Randomized Trial.,"Immersive and non-immersive virtual reality (NIVR) technology can supplement and improve standard physiotherapy and neurorehabilitation in post-stroke patients. We aimed to use MIRA software to investigate the efficiency of specific NIVR therapy as a standalone intervention, versus standardized physiotherapy for upper extremity rehabilitation in patients post-stroke. Fifty-five inpatients were randomized to control groups (applying standard physiotherapy and dexterity exercises) and experimental groups (applying NIVR and dexterity exercises). The two groups were subdivided into subacute (<six months post-stroke) and chronic (>six months to four years post-stroke survival patients). The following standardized tests were applied at baseline and after two weeks post-therapy: Fugl-Meyer Assessment for Upper Extremity (FMUE), the Modified Rankin Scale (MRS), Functional Independence Measure (FIM), Active Range of Motion (AROM), Manual Muscle Testing (MMT), Modified Ashworth Scale (MAS), and Functional Reach Test (FRT). The Kruskal-Wallis test was used to determine if there were significant differences between the groups, followed with pairwise comparisons. The Wilcoxon Signed-Rank test was used to determine the significance of pre to post-therapy changes. The Wilcoxon Signed-Rank test showed significant differences in all four groups regarding MMT, FMUE, and FIM assessments pre- and post-therapy, while for AROM, only experimental groups registered significant differences. Independent Kruskal-Wallis results showed that the subacute experimental group outcomes were statistically significant regarding the assessments, especially in comparison with the control groups. The results suggest that NIVR rehabilitation is efficient to be administered to post-stroke patients, and the study design can be used for a further trial, in the perspective that NIVR therapy can be more efficient than standard physiotherapy within the first six months post-stroke.",2020,"The Wilcoxon Signed-Rank test showed significant differences in all four groups regarding MMT, FMUE, and FIM assessments pre- and post-therapy, while for AROM, only experimental groups registered significant differences.","['Post-Stroke Upper Extremity Rehabilitation', 'Fifty-five inpatients', 'post-stroke patients', 'patients post-stroke']","['NIVR rehabilitation', 'Immersive and non-immersive virtual reality (NIVR) technology', 'control groups (applying standard physiotherapy and dexterity exercises) and experimental groups (applying NIVR and dexterity exercises']","['Modified Rankin Scale (MRS), Functional Independence Measure (FIM), Active Range of Motion (AROM), Manual Muscle Testing (MMT), Modified Ashworth Scale (MAS), and Functional Reach Test (FRT', 'MMT, FMUE, and FIM assessments pre- and post-therapy']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",55.0,0.0314642,"The Wilcoxon Signed-Rank test showed significant differences in all four groups regarding MMT, FMUE, and FIM assessments pre- and post-therapy, while for AROM, only experimental groups registered significant differences.","[{'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Miclaus', 'Affiliation': 'Faculty of Medicine, Transilvania University of Brasov, 500036 Brasov, Romania.'}, {'ForeName': 'Nadinne', 'Initials': 'N', 'LastName': 'Roman', 'Affiliation': 'Faculty of Medicine, Transilvania University of Brasov, 500036 Brasov, Romania.'}, {'ForeName': 'Silviu', 'Initials': 'S', 'LastName': 'Caloian', 'Affiliation': 'Faculty of Medicine, Transilvania University of Brasov, 500036 Brasov, Romania.'}, {'ForeName': 'Brindusa', 'Initials': 'B', 'LastName': 'Mitoiu', 'Affiliation': 'Rehabilitation Department, ""Carol Davila"" University of Medicine and Pharmacy, 0050474 Bucuresti, Romania.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Suciu', 'Affiliation': 'Department of Rehabilitation, Physical Medicine and Rheumatology, ""Victor Babeș"" University of Medicine and Pharmacy in Timisoara, 300041 Timisoara, Romania.'}, {'ForeName': 'Roxana Ramona', 'Initials': 'RR', 'LastName': 'Onofrei', 'Affiliation': 'Department of Rehabilitation, Physical Medicine and Rheumatology, ""Victor Babeș"" University of Medicine and Pharmacy in Timisoara, 300041 Timisoara, Romania.'}, {'ForeName': 'Ecaterina', 'Initials': 'E', 'LastName': 'Pavel', 'Affiliation': 'Faculty of Letters, Transilvania University of Brasov, 500030 Brasov, Romania.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Neculau', 'Affiliation': 'Faculty of Medicine, Transilvania University of Brasov, 500036 Brasov, Romania.'}]",Brain sciences,['10.3390/brainsci10090655']
2792,32975171,Shoulder and scapula muscle training plus conventional physiotherapy versus conventional physiotherapy only: a randomized controlled trial of patients with lateral elbow tendinopathy.,"BACKGROUND


Previous studies have suggested that weakening of shoulder and scapula muscles have been associated with increased pain, and decreased functional abilities in patients with lateral elbow tendinopathy (LET).
PURPOSE


To compare the effects of shoulder and scapula muscle training plus conventional physiotherapy with conventional physiotherapy only.
METHODS


A group of 48 patients with LET was randomly allocated into two groups: shoulder and scapula muscle training plus conventional physiotherapy ( n  = 24), and conventional physiotherapy ( n  = 24). All patients received 12 sessions of treatment for 4 weeks. Furthermore, both groups were instructed to continue their own exercise program at home until four months after the end of treatment. Pain intensity, grip strength, and functional status were measured preintervention, postintervention, and 4 months after the end of intervention (4-month follow-up).
RESULTS


The shoulder and scapula muscle training plus conventional physiotherapy group showed significantly more reduction in pain and greater improvement in functional status compared with conventional physiotherapy group, but there was no significant difference in pain-free grip strength for two groups.
CONCLUSION


Conventional physiotherapy combined with shoulder and scapula muscle training could be more effective in improving the pain and functional abilities of patients with LET compared with conventional physiotherapy only.",2020,"The shoulder and scapula muscle training plus conventional physiotherapy group showed significantly more reduction in pain and greater improvement in functional status compared with conventional physiotherapy group, but there was no significant difference in pain-free grip strength for two groups.
","['A group of 48 patients with LET', 'patients with lateral elbow tendinopathy (LET', 'patients with lateral elbow tendinopathy']","['shoulder and scapula muscle training plus conventional physiotherapy', 'Shoulder and scapula muscle training plus conventional physiotherapy', 'shoulder and scapula muscle training plus conventional physiotherapy ( n  =\xa024), and conventional physiotherapy', 'Conventional physiotherapy combined with shoulder and scapula muscle training']","['functional abilities', 'pain-free grip strength', 'reduction in pain', 'Pain intensity, grip strength, and functional status', 'functional status', 'pain and functional abilities']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C4277745', 'cui_str': 'Elbow Tendinopathy'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0036277', 'cui_str': 'Bone structure of scapula'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",48.0,0.0628067,"The shoulder and scapula muscle training plus conventional physiotherapy group showed significantly more reduction in pain and greater improvement in functional status compared with conventional physiotherapy group, but there was no significant difference in pain-free grip strength for two groups.
","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Mostafaee', 'Affiliation': 'Department of Physical Therapy, School of Paramedical Sciences, Mashhad University of Medical Sciences , Mashhad, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Divandari', 'Affiliation': 'Department of Physical Therapy, School of Paramedical Sciences, Mashhad University of Medical Sciences , Mashhad, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Negahban', 'Affiliation': 'Department of Physical Therapy, School of Paramedical Sciences, Mashhad University of Medical Sciences , Mashhad, Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Kachooei', 'Affiliation': 'Orthopedic Research Center, Mashhad University of Medical Sciences , Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Moradi', 'Affiliation': 'Orthopedic Research Center, Mashhad University of Medical Sciences , Mashhad, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Ebrahimzadeh', 'Affiliation': 'Orthopedic Research Center, Mashhad University of Medical Sciences , Mashhad, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Tabesh', 'Affiliation': 'Department of Medical Informatics, School of Medicine, Mashhad University of Medical Sciences , Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Daghiani', 'Affiliation': 'Department of Physical Therapy, School of Paramedical Sciences, Mashhad University of Medical Sciences , Mashhad, Iran.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1821417']
2793,32975189,"Imiquimod versus podophyllotoxin, with and without human papillomavirus vaccine, for anogenital warts: the HIPvac factorial RCT.","BACKGROUND


The comparative efficacy, and cost-effectiveness, of imiquimod or podophyllotoxin cream, either alone or in combination with the quadrivalent HPV vaccine (Gardasil ® , Merck Sharp & Dohme Corp., Merck & Co., Inc., Whitehouse Station, NJ, USA) in the treatment and prevention of recurrence of anogenital warts is not known.
OBJECTIVE


The objective was to compare the efficacy of imiquimod and podophyllotoxin creams to treat anogenital warts and to assess whether or not the addition of quadrivalent human papillomavirus vaccine increases wart clearance or prevention of recurrence.
DESIGN


A randomised, controlled, multicentre, partially blinded factorial trial. Participants were randomised equally to four groups, combining either topical treatment with quadrivalent human papillomavirus vaccine or placebo. Randomisation was stratified by gender, a history of previous warts and human immunodeficiency virus status. There was an accompanying economic evaluation, conducted from the provider perspective over the trial duration.
SETTING


The setting was 22 sexual health clinics in England and Wales.
PARTICIPANTS


Participants were patients with a first or repeat episode of anogenital warts who had not been treated in the previous 3 months and had not previously received quadrivalent human papillomavirus vaccine.
INTERVENTIONS


Participants were randomised to 5% imiquimod cream (Aldara ® ; Meda Pharmaceuticals, Takeley, UK) for up to 16 weeks or 0.15% podophyllotoxin cream (Warticon ® ; GlaxoSmithKlein plc, Brentford, UK) for 4 weeks, which was extended to up to 16 weeks if warts persisted. Participants were simultaneously randomised to quadrivalent human papillomavirus vaccine (Gardasil) or saline control at 0, 8 and 24 weeks. Cryotherapy was permitted after week 4 at the discretion of the investigator.
MAIN OUTCOME MEASURES


The main outcome measures were a combined primary outcome of wart clearance at week 16 and remaining wart free at week 48. Efficacy analysis was by logistic regression with multiple imputation for missing follow-up values; economic evaluation considered the costs per quality-adjusted life-year.
RESULTS


A total of 503 participants were enrolled and attended at least one follow-up visit. The mean age was 31 years, 66% of participants were male (24% of males were men who have sex with men), 50% had a previous history of warts and 2% were living with human immunodeficiency virus. For the primary outcome, the adjusted odds ratio for imiquimod cream versus podophyllotoxin cream was 0.81 (95% confidence interval 0.54 to 1.23), and for quadrivalent human papillomavirus vaccine versus placebo, the adjusted odds ratio was 1.46 (95% confidence interval 0.97 to 2.20). For the components of the primary outcome, the adjusted odds ratio for wart free at week 16 for imiquimod versus podophyllotoxin was 0.77 (95% confidence interval 0.52 to 1.14) and for quadrivalent human papillomavirus vaccine versus placebo was 1.30 (95% confidence interval 0.89 to 1.91). The adjusted odds ratio for remaining wart free at 48 weeks (in those who were wart free at week 16) for imiquimod versus podophyllotoxin was 0.98 (95% confidence interval 0.54 to 1.78) and for quadrivalent human papillomavirus vaccine versus placebo was 1.39 (95% confidence interval 0.73 to 2.63). Podophyllotoxin plus quadrivalent human papillomavirus vaccine had inconclusive cost-effectiveness compared with podophyllotoxin alone.
LIMITATIONS


Hepatitis A vaccine as control was replaced by a saline placebo in a non-identical syringe, administered by someone outside the research team, for logistical reasons. Sample size was reduced from 1000 to 500 because of slow recruitment and other delays.
CONCLUSIONS


A benefit of the vaccine was not demonstrated in this trial. The odds of clearance at week 16 and remaining clear at week 48 were 46% higher with vaccine, and consistent effects were seen for both wart clearance and recurrence separately, but these differences were not statistically significant. Imiquimod and podophyllotoxin creams had similar efficacy for wart clearance, but with a wide confidence interval. The trial results do not support earlier evidence of a lower recurrence with use of imiquimod than with use of podophyllotoxin. Podophyllotoxin without quadrivalent human papillomavirus vaccine is the most cost-effective strategy at the current vaccine list price. A further larger trial is needed to definitively investigate the effect of the vaccine; studies of the immune response in vaccine recipients are needed to investigate the mechanism of action.
TRIAL REGISTRATION


Current Controlled Trials. Current Controlled Trials ISRCTN32729817 and EudraCT 2013-002951-14.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 47. See the NIHR Journals Library website for further project information.",2020,"Imiquimod and podophyllotoxin creams had similar efficacy for wart clearance, but with a wide confidence interval.","['The mean age was 31 years, 66% of participants were male (24% of males were men who have sex with men), 50% had a previous history of warts and 2% were living with human immunodeficiency virus', '503 participants were enrolled and attended at least one follow-up visit', 'Participants were patients with a first or repeat episode of anogenital warts who had not been treated in the previous 3 months and had not previously received quadrivalent human papillomavirus vaccine', 'anogenital warts', '22 sexual health clinics in England and Wales']","['saline placebo', 'imiquimod', 'imiquimod or podophyllotoxin cream, either alone or in combination with the quadrivalent HPV vaccine (Gardasil ® , Merck Sharp & Dohme Corp., Merck & Co., Inc., Whitehouse Station, NJ, USA', 'imiquimod and podophyllotoxin creams', 'podophyllotoxin cream', 'topical treatment with quadrivalent human papillomavirus vaccine or placebo', 'podophyllotoxin', 'Podophyllotoxin plus quadrivalent human papillomavirus vaccine', 'vaccine', 'Cryotherapy', 'placebo', 'quadrivalent human papillomavirus vaccine (Gardasil) or saline control', 'imiquimod cream (Aldara ® ; Meda Pharmaceuticals, Takeley, UK) for up to 16 weeks or 0.15% podophyllotoxin cream (Warticon ® ; GlaxoSmithKlein plc, Brentford, UK', 'imiquimod versus podophyllotoxin', 'Imiquimod and podophyllotoxin creams', 'Podophyllotoxin without quadrivalent human papillomavirus vaccine', 'Imiquimod versus podophyllotoxin, with and without human papillomavirus vaccine']","['wart clearance', 'odds of clearance', 'adjusted odds ratio for imiquimod cream', 'adjusted odds ratio for remaining wart free', 'adjusted odds ratio for wart free']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0009663', 'cui_str': 'Genital warts'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C1721787', 'cui_str': 'Gardasil'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1252977', 'cui_str': 'imiquimod Topical Cream'}, {'cui': 'C0718327', 'cui_str': 'Aldara'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0592268', 'cui_str': 'Warticon'}]","[{'cui': 'C0043037', 'cui_str': 'Verruca'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1252977', 'cui_str': 'imiquimod Topical Cream'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",503.0,0.405304,"Imiquimod and podophyllotoxin creams had similar efficacy for wart clearance, but with a wide confidence interval.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gilson', 'Affiliation': 'University College London Centre for Clinical Research in Infection and Sexual Health, Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Diarmuid', 'Initials': 'D', 'LastName': 'Nugent', 'Affiliation': 'University College London Centre for Clinical Research in Infection and Sexual Health, Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Doré', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Macey L', 'Initials': 'ML', 'LastName': 'Murray', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Meadows', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Haddow', 'Affiliation': 'University College London Centre for Clinical Research in Infection and Sexual Health, Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lacey', 'Affiliation': 'Centre for Immunology and Infection, Hull York Medical School, University of York, York, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sandmann', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jit', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Soldan', 'Affiliation': 'Statistics, Modelling and Economics Department, Public Health England, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Tetlow', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Caverly', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Mayura', 'Initials': 'M', 'LastName': 'Nathan', 'Affiliation': 'Homerton Anogenital Neoplasia Service, Homerton University Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Copas', 'Affiliation': 'Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24470']
2794,32975202,Drug-drug interaction of rivaroxaban and calcium channel blockers in patients aged 80 years and older with nonvalvular atrial fibrillation.,"Objectives For revealing the peculiarities of the drug-drug interaction of rivaroxaban (substrate CYP3A4 and P-gp) and calcium channel blockers (CCBs) (verapamil - inhibitor CYP3A4 and P-gp and amlodipine - substrate CYP3A4) in patients 80 years and older with nonvalvular atrial fibrillation (NAF) we studied 128 patients. Methods All patients were divided into groups depending on the therapy taken: the 1st - rivaroxaban + amlodipine (n=51), the 2nd - rivaroxaban + verapamil (n=30), the control group - rivaroxaban without CCBs (n=47). A trough steady-state plasma concentration (C min,ss) of rivaroxaban, prothrombin time (PT) in the blood plasma and the event of clinically relevant non-major (CRNM) bleeding were assessed for each patient. Results Patient in group 2 had higher C min,ss of rivaroxaban, PT and CRNM than subjects in the control group (Me 73.8 [50.6-108.8] ng/mL vs. 40.5 [25.6-74.3] ng/mL; Me 14.8 [13.4-17.3] s vs. 13.8 [12.6-14.4] s; 34% vs. 13%, respectively, p<0.05 for all). When compared, the PT and complication rate in group 1 with the control group C min,ss of rivaroxaban were practically the same (p>0.05 for all). Conclusions In patients ≥80 years with NAF, the use of rivaroxaban in combination with verapamil may not be safe and can lead to CRNM bleeding.",2020,"Results Patient in group 2 had higher C min,ss of rivaroxaban, PT and CRNM than subjects in the control group (Me 73.8 [50.6-108.8] ng/mL vs. 40.5 [25.6-74.3] ng/mL; Me 14.8 [13.4-17.3] s vs. 13.8 [12.6-14.4] s; 34% vs. 13%, respectively, p<0.05 for all).","['patients aged 80 years and older with nonvalvular atrial fibrillation', '128 patients', 'patients 80 years and older with nonvalvular atrial fibrillation (NAF']","['rivaroxaban', 'rivaroxaban\xa0+ amlodipine', 'verapamil', 'control group\xa0- rivaroxaban without CCBs', 'rivaroxaban and calcium channel blockers', 'rivaroxaban\xa0+ verapamil', 'rivaroxaban (substrate CYP3A4 and P-gp) and calcium channel blockers (CCBs) (verapamil\xa0- inhibitor CYP3A4 and P-gp and amlodipine\xa0- substrate CYP3A4']","['PT and complication rate', 'A trough steady-state plasma concentration (C min,ss) of rivaroxaban, prothrombin time (PT) in the blood plasma and the event of clinically relevant non-major (CRNM) bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C1142644', 'cui_str': 'cytochrome P450 3A4 protein, human'}, {'cui': 'C0069906', 'cui_str': 'P-Glycoproteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",128.0,0.0220277,"Results Patient in group 2 had higher C min,ss of rivaroxaban, PT and CRNM than subjects in the control group (Me 73.8 [50.6-108.8] ng/mL vs. 40.5 [25.6-74.3] ng/mL; Me 14.8 [13.4-17.3] s vs. 13.8 [12.6-14.4] s; 34% vs. 13%, respectively, p<0.05 for all).","[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Sychev', 'Affiliation': 'Department of Clinical Pharmacology and Therapy of Federal State Budgetary Educational Institution of Further Professional Education ""Russian Medical Academy of Continuous Professional Education"" of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mirzaev', 'Affiliation': 'Department of Personalized Medicine, Research Institute of Molecular and Personalized Medicine of Federal State Budgetary Educational Institution of Further Professional Education ""Russian Medical Academy of Continuous Professional Education"" of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Cherniaeva', 'Affiliation': 'Department of Internal and Preventive Medicine of Federal State Budgetary Institution of Higher Professional Education ""Central State Medical Academy of the Presidential Administration of the Russian Federation"", Marshal Timoshenko street,19, building 1A, 121359, Moscow, Russia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kulikova', 'Affiliation': 'Department of Clinical Pharmacology and Therapy of Federal State Budgetary Educational Institution of Further Professional Education ""Russian Medical Academy of Continuous Professional Education"" of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Bochkov', 'Affiliation': 'Department of Personalized Medicine, Research Institute of Molecular and Personalized Medicine of Federal State Budgetary Educational Institution of Further Professional Education ""Russian Medical Academy of Continuous Professional Education"" of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Shevchenko', 'Affiliation': 'Department of Personalized Medicine, Research Institute of Molecular and Personalized Medicine of Federal State Budgetary Educational Institution of Further Professional Education ""Russian Medical Academy of Continuous Professional Education"" of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Gorbatenkova', 'Affiliation': 'State Budgetary Institution of Health ""Hospital for War Veterans No. 2"" of the Department of Health of Moscow, Volgogradsky prospect, Moscow, Russia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Golovina', 'Affiliation': 'Department of Clinical Pharmacology and Therapy of Federal State Budgetary Educational Institution of Further Professional Education ""Russian Medical Academy of Continuous Professional Education"" of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Ostroumova', 'Affiliation': 'Department of Therapy and Polymorbid Pathology of Federal State Budgetary Educational Institution of Further Professional Education ""Russian Medical Academy of Continuous Professional Education"" of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Damirya', 'Initials': 'D', 'LastName': 'Bahteeva', 'Affiliation': 'Department of Clinical Pharmacology and Therapy of Federal State Budgetary Educational Institution of Further Professional Education ""Russian Medical Academy of Continuous Professional Education"" of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rytkin', 'Affiliation': 'Department of Clinical Pharmacology and Therapy of Federal State Budgetary Educational Institution of Further Professional Education ""Russian Medical Academy of Continuous Professional Education"" of the Ministry of Healthcare of the Russian Federation, Moscow, Russia.'}]",Drug metabolism and personalized therapy,['10.1515/dmpt-2020-0127']
2795,32975296,REAC-induced endogenous bioelectric currents in the treatment of venous ulcers: a three-arm randomized controlled prospective study.,"INTRODUCTION


Endogenous bioelectric fields (EBFs) play a fundamental role in promoting repair and regeneration processes, including in leg venous ulcers (LVUs). Unfortunately, the mechanism underlying the production of EBFs is easily altered by infectious, traumatic, and epigenetic factors. This alteration is one of the determining factors for the chronicity of LVUs. This study investigates how radioelectric asymmetric conveyer (REAC) technology treatments, specifically designed to optimize EBFs, and in particular tissue optimization-reparative (TO-RPR) treatment, can improve the results of standard dressing with and without elastic compression in LVU patients.
METHODS


A total of 30 patients were enrolled (12 males and 18 females) and randomized into three groups. All patients completed the study. Group A was treated with standard dressing, elastic compression, and REAC TO-RPR treatment; Group B was treated with standard dressing and REAC TO-RPR treatment; and Group C was treated with standard dressing and elastic compression.
RESULTS


The results show that the combination of REAC treatment and standard dressing associated with elastic compression has the greatest therapeutic efficacy in promoting the healing process for ulcers, reducing perceived pain, and improving the quality of life of the patients treated.
CONCLUSIONS


Further studies will be useful to investigate these prospective results.",2020,"The results show that the combination of REAC treatment and standard dressing associated with elastic compression has the greatest therapeutic efficacy in promoting the healing process for ulcers, reducing perceived pain, and improving the quality of life of the patients treated.
","['LVU patients', 'venous ulcers', '30 patients were enrolled (12 males and 18 females']","['standard dressing, elastic compression, and REAC TO-RPR treatment; Group B was treated with standard dressing and REAC TO-RPR treatment; and Group C was treated with standard dressing and elastic compression', 'REAC', 'REAC-induced endogenous bioelectric currents']",['quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042344', 'cui_str': 'Stasis ulcer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",30.0,0.0239052,"The results show that the combination of REAC treatment and standard dressing associated with elastic compression has the greatest therapeutic efficacy in promoting the healing process for ulcers, reducing perceived pain, and improving the quality of life of the patients treated.
","[{'ForeName': 'Concettina', 'Initials': 'C', 'LastName': 'Elio', 'Affiliation': 'Interuniversity Center for Phlebolymphology, Magna Graecia University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Fontani', 'Affiliation': 'Department of Regenerative Medicine, Rinaldi Fontani Institute, Florence, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Rinaldi', 'Affiliation': 'Department of Regenerative Medicine, Rinaldi Fontani Institute, Florence, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Gasbarro', 'Affiliation': 'Department of Morphology, Surgery, and Experimental Medicine, Section of Clinical Surgery, University of Ferrara, Ferrara, Italy.'}]","Acta dermatovenerologica Alpina, Pannonica, et Adriatica",[]
2796,32975556,"HPV Vaccination Prior to Loop Electroexcision Procedure does not Prevent Recurrent Cervical High Grade Squamous Intraepithelial Lesions in Women Living with HIV: a Randomized, Double-blind, Placebo-controlled Trial.","BACKGROUND


Women living with HIV, especially in sub-Saharan Africa, are at high risk for cervical high-grade squamous intraepithelial lesions (HSIL) and cervical cancer. These women have high HSIL recurrence rates after loop electroexcision procedure (LEEP). Retrospective studies suggest that HPV vaccination improves response to treatment of cervical HSIL.
METHODS


We performed a double-blind, randomized clinical trial enrolling 180 women living with HIV in Johannesburg, South Africa diagnosed with cervical HSIL by colposcopic biopsy. Women received quadrivalent HPV vaccine or placebo (1:1) at entry, week 4, and week 26. LEEP was performed at week 4. Colposcopic directed biopsies and cervical cytology were performed at week 26 and 52. The primary endpoint, cervical HSIL by histology or cytology at either week 26 or 52, was compared between arms using Chi-square analysis.
RESULTS


Participant characteristics included median age 39 years, median CD4 489 cells/mm3, and 94% had HIV suppression. 174 women completed the vaccine/placebo series and had evaluable results at week 26 or 52. The proportion experiencing the primary endpoint was similar in the vaccine and placebo groups, 53% vs. 45% (RR 1.16, 95% CI .87-1.6, P=.29). HSIL recurrence was associated with a LEEP biopsy result of HSIL and detection of HSIL at the margins of LEEP sample.
CONCLUSION


This study did not support HPV vaccination to prevent recurrent HSIL after LEEP in women living with HIV. Recurrent HSIL was high despite virologic suppression. Improved treatments are needed for HSIL to reduce the burden of cervical cancer among women living with HIV.",2020,"The proportion experiencing the primary endpoint was similar in the vaccine and placebo groups, 53% vs. 45% (RR 1.16, 95% CI .87-1.6, P=.29).","['174 women completed the', 'Women Living with HIV', 'Women living with HIV, especially in sub-Saharan Africa, are at high risk for cervical high-grade squamous intraepithelial lesions (HSIL) and cervical cancer', '180 women living with HIV in Johannesburg, South Africa diagnosed with cervical HSIL by colposcopic biopsy', 'Participant characteristics included median age 39 years, median CD4 489 cells/mm3, and 94% had HIV suppression', 'women living with HIV']","['HPV vaccination', 'HPV Vaccination Prior to Loop Electroexcision Procedure', 'LEEP', 'vaccine/placebo', 'quadrivalent HPV vaccine or placebo', 'Placebo']","['cervical HSIL by histology or cytology', 'Colposcopic directed biopsies and cervical cytology', 'HSIL recurrence', 'burden of cervical cancer', 'HSIL recurrence rates', 'Recurrent Cervical High Grade Squamous Intraepithelial Lesions']","[{'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1512433', 'cui_str': 'Cervical high grade squamous intraepithelial lesion'}, {'cui': 'C0333875', 'cui_str': 'High-grade squamous intraepithelial lesion'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}]","[{'cui': 'C1512433', 'cui_str': 'Cervical high grade squamous intraepithelial lesion'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0856201', 'cui_str': 'Cervical cytology'}, {'cui': 'C0333875', 'cui_str': 'High-grade squamous intraepithelial lesion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",180.0,0.782454,"The proportion experiencing the primary endpoint was similar in the vaccine and placebo groups, 53% vs. 45% (RR 1.16, 95% CI .87-1.6, P=.29).","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Firnhaber', 'Affiliation': 'Department of Medicine, Division of Infectious Disease, University of Colorado Medical School, Aurora, CO.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Swarts', 'Affiliation': 'Department of Clinical Medicine Clinical HIV Research Unit University of Witwatersrand, Johannesburg South Africa.'}, {'ForeName': 'Vuyokazi', 'Initials': 'V', 'LastName': 'Jezile', 'Affiliation': 'Department of Clinical Medicine Clinical HIV Research Unit University of Witwatersrand, Johannesburg South Africa.'}, {'ForeName': 'Masango', 'Initials': 'M', 'LastName': 'Mulongo', 'Affiliation': 'Department of Clinical Medicine Clinical HIV Research Unit University of Witwatersrand, Johannesburg South Africa.'}, {'ForeName': 'Bridgette', 'Initials': 'B', 'LastName': 'Goeieman', 'Affiliation': 'Right to Care Helen Joseph Hospital Johannesburg South Africa.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Right to Care Helen Joseph Hospital Johannesburg South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Faesen', 'Affiliation': 'Right to Care Helen Joseph Hospital Johannesburg South Africa.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Michelow', 'Affiliation': 'Department of Anatomical Pathology, University of the Witwatersrand, Johannesburg South Africa.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wilkin', 'Affiliation': 'Division of Infectious Diseases, Weill-Cornell Medical College, New York, NY.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1456']
2797,32975624,Dexmedetomidine combined with suprascapular nerve block and axillary nerve block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair.,"PURPOSE


Suprascapular nerve block (SSNB) is the most commonly used block for the relief of postoperative pain from arthroscopic rotator cuff repair and can be used in combination with axillary nerve block (ANB). Dexmedetomidine (DEX) is a type of alpha agonist that can elongate the duration of regional block. The aim of this study was to compare the effects of the use of dexmedetomidine combined with SSNB and ANB with those of the use of SSNB and ANB alone on postoperative pain, satisfaction, and pain-related cytokines within the first 48 h after arthroscopic rotator cuff repair.
METHODS


Forty patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled in this single-center, double-blinded randomized controlled trial study. Twenty patients were randomly allocated to group 1 and received ultrasound-guided SSNB and ANB using a mixture of 0.5 ml (50 μg) of DEX and 9.5 ml of 0.75% ropivacaine preemptively. The other 20 patients were allocated to group 2 and underwent ultrasound-guided SSNB and ANB alone using a mixture of 0.5 ml of normal saline and 9.5 ml of ropivacaine. The visual analog scale (VAS) for pain and patient satisfaction (SAT) scores were postoperatively checked within 48 h. The plasma interleukin (IL)-6, IL-8, IL-1β, cortisol, and serotonin levels were also postoperatively measured within 48 h.
RESULTS


Group 1 showed a significantly lower mean VAS (visual analog scale of pain) score 1, 3, 6, 12, 18 and 24 h after operation, and a significantly higher mean SAT (patient satisfaction) score 1, 3, 6, 12, 18, 24 and 36 h after the operation than group 2. Group 1 showed a significantly lower mean plasma IL-8 level 1 and 48 h after the operation, and a significantly lower mean IL-1β level 48 h after the operation than group 2. Group 1 showed a significantly lower mean plasma serotonin level 12 h after the operation than group 2. The mean timing of rebound pain in group 1 was significantly later than that in group 2 (36 h > 23 h, p = 0.007). Six patients each in groups 1 and 2 showed rebound pain. The others did not show rebound pain.
CONCLUSIONS


Ultrasound-guided SSNA and ANB with DEX during arthroscopic rotator cuff repair resulted in a significantly lower mean VAS score and a significantly higher mean SAT score within 48 h after the operation than SSNB and ANB alone. Additionally, SSNB and ANB with DEX tended to result in a later mean timing of rebound pain accompanied by significant changes in IL-8, IL-1β, and serotonin levels within 48 h after the operation. The present study could provide the basis for selecting objective parameters of postoperative pain in deciding the optimal use of medication for relieving pain.
LEVEL OF EVIDENCE


Level I.
TRIAL REGISTRATION


2015-20, ClinicalTrials.gov Identifier: NCT04398589.
IRB NUMBER


2015-20, Hallym University Chuncheon Sacred Heart Hospital.",2020,"The plasma interleukin (IL)-6, IL-8, IL-1β, cortisol, and serotonin levels were also postoperatively measured within 48 h.
","['20 patients', 'arthroscopic rotator cuff repair', 'Twenty patients', 'Forty patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled in this single-center']","['SSNB and ANB alone', 'DEX and 9.5\xa0ml of 0.75% ropivacaine', 'DEX', 'Dexmedetomidine combined with suprascapular nerve block and axillary nerve block', 'Suprascapular nerve block (SSNB', 'ultrasound-guided SSNB and ANB alone using a mixture of 0.5\xa0ml of normal saline and 9.5\xa0ml of ropivacaine', 'dexmedetomidine combined with SSNB and ANB', 'ultrasound-guided SSNB and ANB', 'Dexmedetomidine (DEX']","['postoperative pain, satisfaction, and pain-related cytokines', 'mean SAT score', 'mean VAS (visual analog scale of pain) score', 'IL-8, IL-1β, and serotonin levels', 'plasma interleukin (IL)-6, IL-8, IL-1β, cortisol, and serotonin levels', 'mean plasma serotonin level', 'mean VAS score', 'rebound pain', 'mean plasma IL-8 level', 'mean timing of rebound pain', 'visual analog scale (VAS) for pain and patient satisfaction (SAT) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0860482', 'cui_str': 'Axillary nerve block'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0202217', 'cui_str': 'Serotonin measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",20.0,0.126737,"The plasma interleukin (IL)-6, IL-8, IL-1β, cortisol, and serotonin levels were also postoperatively measured within 48 h.
","[{'ForeName': 'Jae Jun', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Anesthesiology and Pain Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical College, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Do-Young', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Chuncheon Sacred Heart Hospital, Hallym University Medical College, 77, Sakju-ro, Chuncheon-si, Gangwon-do, 24253, Republic of Korea.'}, {'ForeName': 'Jung-Taek', 'Initials': 'JT', 'LastName': 'Hwang', 'Affiliation': 'Department of Orthopedic Surgery, Chuncheon Sacred Heart Hospital, Hallym University Medical College, 77, Sakju-ro, Chuncheon-si, Gangwon-do, 24253, Republic of Korea. drakehjt@hanmail.net.'}, {'ForeName': 'Dong-Keun', 'Initials': 'DK', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacology, Hallym University Medical College, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Han Na', 'Initials': 'HN', 'LastName': 'Lee', 'Affiliation': 'Anesthesiology and Pain Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical College, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Ji Su', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Anesthesiology and Pain Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical College, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Sang-Soo', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Chuncheon Sacred Heart Hospital, Hallym University Medical College, 77, Sakju-ro, Chuncheon-si, Gangwon-do, 24253, Republic of Korea.'}, {'ForeName': 'Sung Mi', 'Initials': 'SM', 'LastName': 'Hwang', 'Affiliation': 'Anesthesiology and Pain Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical College, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Moon', 'Affiliation': 'Department of Orthopedic Surgery, Kangwon National University Hospital, Kangwon National University Medical College, Chuncheon-si, Republic of Korea.'}, {'ForeName': 'Jae-Hoon', 'Initials': 'JH', 'LastName': 'Shim', 'Affiliation': 'Department of Orthopedic Surgery, Chuncheon Sacred Heart Hospital, Hallym University Medical College, 77, Sakju-ro, Chuncheon-si, Gangwon-do, 24253, Republic of Korea.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06288-8']
2798,32975679,"Effect of Empagliflozin on Liver Steatosis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease Without Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial.","INTRODUCTION


Despite the high prevalence of non-alcoholic fatty liver disease (NAFLD) and its associated co-morbidities, no efficient treatment in a high percentage of individuals is available. Beneficial effects of sodium-glucose co-transporter 2 inhibitors on fatty liver have been investigated in people with type 2 diabetes (T2DM). The aim of this study was to explore the effect of empagliflozin on liver steatosis and fibrosis in patients with NAFLD without T2DM.
METHODS


In this prospective randomized, double-blind, placebo-controlled clinical trial, participants with NAFLD were randomized to empagliflozin (10 mg/day) (n = 43) or placebo (n = 47) for 24 weeks. Hepatic steatosis and fibrosis were assessed using transient elastography to measure the controlled attenuation parameter (CAP) and liver stiffness measurement (LSM). The primary outcome was the change in CAP score at 24 weeks.
RESULTS


There was significant decrease in CAP score in both groups but no significant difference was observed between the two groups (P = 0.396). LSM was significantly decreased in the empagliflozin-treated group (6.03 ± 1.40 to 5.33 ± 1.08 kPa; P = 0.001), while no change was found in the placebo group. In subgroups analysis of patients with significant steatosis at baseline (CAP ≥ 302 dB/m), steatosis significantly improved in the empagliflozin group (37.2% vs. 17%; P = 0.035). There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
CONCLUSIONS


Empagliflozin improves liver steatosis and, more importantly, measures of liver fibrosis in patients with NAFLD without T2DM.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, IRCT20190122042450N1.",2020,"There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
","['people with type\xa02 diabetes (T2DM', 'Without Diabetes', 'participants with NAFLD', '302\xa0dB/m', 'Patients With Non-Alcoholic Fatty Liver Disease', 'patients with NAFLD without T2DM', 'patients with significant steatosis at baseline (CAP\u2009≥']","['empagliflozin', 'placebo', 'sodium-glucose co-transporter\xa02 inhibitors', 'Empagliflozin', 'Placebo']","['change in CAP score', 'controlled attenuation parameter (CAP) and liver stiffness measurement (LSM', 'Hepatic steatosis and fibrosis', 'grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels', 'Liver Steatosis and Fibrosis', 'LSM', 'liver fibrosis', 'liver steatosis and fibrosis', 'liver steatosis', 'CAP score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]",,0.63044,"There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
","[{'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Taheri', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Malek', 'Affiliation': 'Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran. malek.m@iums.ac.ir.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Ismail-Beigi', 'Affiliation': 'Department of Medicine, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Zamani', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Masoudreza', 'Initials': 'M', 'LastName': 'Sohrabi', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Reza Babaei', 'Affiliation': 'Department of Interventional Radiology, Firouzgar Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad E', 'Initials': 'ME', 'LastName': 'Khamseh', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Advances in therapy,['10.1007/s12325-020-01498-5']
2799,32975703,"Comparison of the effects of air-powder abrasion, chemical decontamination, or their combination in open-flap surface decontamination of implants failed for peri-implantitis: an ex vivo study.","OBJECTIVES


To compare, using an ex vivo model, the biofilm removal of three surface decontamination methods following surgical exposure of implants failed for severe peri-implantitis.
MATERIALS AND METHODS


The study design was a single-blind, randomized, controlled, ex vivo investigation with intra-subject control. Study participants were 20 consecutive patients with at least 4 hopeless implants, in function for >12 months and with progressive bone loss exceeding 50%, which had to be explanted. Implants of each patient were randomly assigned to the untreated control group or one of the three decontamination procedures: mechanical debridement with air-powder abrasion, chemical decontamination with hydrogen peroxide and chlorhexidine gluconate, or combined mechanical-chemical decontamination. Following surgical exposure, implants selected as control were retrieved, and afterwards, test implants were decontaminated according to allocation and carefully explanted with a removal kit. Microbiological analysis was expressed in colony-forming-units (CFU/ml).
RESULTS


A statistically significant difference (p < 0.001) in the concentrations of CFU/ml was found between implants treated with mechanical debridement (531.58 ± 372.07) or combined mechanical-chemical decontamination (954.05 ± 2219.31) and implants untreated (37,800.00 ± 46,837.05) or treated with chemical decontamination alone (29,650.00 ± 42,596.20). No statistically significant difference (p = 1.000) was found between mechanical debridement used alone or supplemented with chemical decontamination. Microbiological analyses identified 21 microbial species, without significant differences between control and treatment groups.
CONCLUSIONS


Bacterial biofilm removal from infected implant surfaces was significantly superior for mechanical debridement than chemical decontamination.
CLINICAL RELEVANCE


The present is the only ex vivo study based on decontamination methods for removing actual and mature biofilm from infected implant surfaces in patients with peri-implantitis.",2020,"A statistically significant difference (p < 0.001) in the concentrations of CFU/ml was found between implants treated with mechanical debridement (531.58 ± 372.07) or combined mechanical-chemical decontamination (954.05 ± 2219.31) and implants untreated (37,800.00 ± 46,837.05) or treated with chemical decontamination alone (29,650.00 ± 42,596.20).","['patients with peri-implantitis', 'Study participants were 20 consecutive patients with at least 4 hopeless implants, in function for >12 months and with progressive bone loss exceeding 50%, which had to be explanted']","['mechanical debridement with air-powder abrasion, chemical decontamination with hydrogen peroxide and chlorhexidine gluconate, or combined mechanical-chemical decontamination', 'air-powder abrasion, chemical decontamination, or their combination', 'mechanical debridement']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]",[],20.0,0.0695772,"A statistically significant difference (p < 0.001) in the concentrations of CFU/ml was found between implants treated with mechanical debridement (531.58 ± 372.07) or combined mechanical-chemical decontamination (954.05 ± 2219.31) and implants untreated (37,800.00 ± 46,837.05) or treated with chemical decontamination alone (29,650.00 ± 42,596.20).","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Pranno', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Maria Paola', 'Initials': 'MP', 'LastName': 'Cristalli', 'Affiliation': 'Department of Biotechnologies and Medical Surgical Sciences, Sapienza University of Rome, 6. Caserta St., 00161, Rome, Italy. mariapaola.cristalli@uniroma1.it.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mengoni', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Sauzullo', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Annibali', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Polimeni', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'La Monaca', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, Sapienza University of Rome, Rome, Italy.'}]",Clinical oral investigations,['10.1007/s00784-020-03578-w']
2800,32967391,The Analgesic Efficacy of Pecto-Intercostal Fascial Block Combined with Pectoral Nerve Block in Modified Radical Mastectomy: A Prospective Randomized Trial.,"BACKGROUND


Pectoral nerve (Pecs) block is one of the most promising regional analgesic techniques for breast surgery. However, Pecs II block may not provide analgesia of the medial aspect of the breast or the entire nipple-areolar complex.
OBJECTIVES


The aim of the present study was to investigate the efficacy of combining the pecto-intercostal fascial block (PIFB) and Pecs II block for perioperative analgesia following modified radical mastectomy (MRM).
STUDY DESIGN


A prospective randomized study.
SETTING


An academic medical center.
METHODS


Sixty women undergoing unilateral MRM were randomly divided into 2 groups. The Pecs II group received Pecs II block using 20 mL bupivacaine 0.25% between the serratus anterior and the external intercostal muscles, and 10 mL bupivacaine 0.25% between the pectoralis major and minor muscles, together with sham PIFB using 15 mL normal saline solution in the interfascial plane between the pectoralis major muscle and the external intercostal muscle. PIFB-Pecs II group received the same Pecs II block combined with PIFB using 15 mL bupivacaine 0.25%.
RESULTS


The median (interquartile range [IQR]) time to the first morphine dose was significantly longer in the PIFB-Pecs II group (327.5 [266.3-360.0] minutes) than the Pecs II group (196 [163.8-248.8] minutes) (P < 0.001, 95% confidence interval [CI] 79.98, 150.00).The median (IQR) cumulative morphine consumption was higher in the Pecs II group (14.0 [11.0-18.0] mg) than the PIFB-Pecs II group (8.0 [7.0-9.0] mg) (P < 0.001; CI, 4.0-8.0). Intraoperative consumption of fentanyl was significantly lower in PIFB-Pecs II group with a median (IQR) of 0 (0-15 mu g) than the Pecs II group median 57.5 (0-75 mu g) (P = 0.022, CI; 0-60). The Visual Analog Scale scores for the first 12 postoperative hours were lower in the PIFB-Pecs II group than the Pecs II group at rest and on moving the ipsilateral arm (P < 0.001). The dermatomal block on the lateral chest wall was comparable between the 2 studied groups. PIFB-Pecs II provided extensive sensory block on the anterior chest wall, whereas Pecs II block failed to achieve any sensory block.
LIMITATIONS


This study was limited by its small sample size.
CONCLUSIONS


The combination of Pecs II and PIFB provide better perioperative analgesia for MRM than Pecs II alone.",2020,The Visual Analog Scale scores for the first 12 postoperative hours were lower in the PIFB-Pecs II group than the Pecs II group at rest and on moving the ipsilateral arm (P < 0.001).,"['An academic medical center', 'Modified Radical Mastectomy', 'Sixty women undergoing unilateral MRM']","['bupivacaine', 'modified radical mastectomy (MRM', 'bupivacaine 0.25% between the pectoralis major and minor muscles, together with sham PIFB using 15 mL normal saline solution', 'PIFB-Pecs II provided extensive sensory block', 'Pecto-Intercostal Fascial Block Combined with Pectoral Nerve Block', 'pecto-intercostal fascial block (PIFB) and Pecs II block']","['Visual Analog Scale scores', 'median (interquartile range [IQR]) time', 'median (IQR) cumulative morphine consumption', 'Intraoperative consumption of fentanyl']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0055065', 'cui_str': 'CEP combination'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]",60.0,0.0509106,The Visual Analog Scale scores for the first 12 postoperative hours were lower in the PIFB-Pecs II group than the Pecs II group at rest and on moving the ipsilateral arm (P < 0.001).,"[{'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Abu Elyazed', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Abdelghany', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Shaimaa F', 'Initials': 'SF', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Pain physician,[]
2801,32967392,"The Efficacy of Scrambler Therapy for the Management of Head, Neck and Thoracic Cancer Pain: A Randomized Controlled Trial.","BACKGROUND


Pain is still a common feature in all types of cancers including head and neck and thoracic cancer. Neuromodulatory techniques have gained popularity over opioids in recent times because of the risks associated with chronic opioid therapy. There are no clinical trials evaluating the efficacy of scrambler therapy (ST) for the management of pain due to head and neck and thoracic cancer.
OBJECTIVE


This trial was undertaken to evaluate the efficacy of scrambler therapy (ST) for pain relief and to assess the possible effect of ST on the dosage of opioids in patients suffering from cancer pain.
STUDY DESIGN


A randomized control trial (RCT) was performed.
SETTING


The trial was conducted at the Pain and Palliative Care Unit of the Dr. B.R. Ambedkar Institute Rotary Cancer Hospital of All India Institute of Medical Sciences, New Delhi, India.
METHOD


Forty patients were included in each of the 2 arms, control and Intervention. In both arms, patients were given pain management drugs. In the intervention group, patients additionally received 10 consecutive sessions of ST with one follow-up after 7 days. A numeric rating scale (NRS-11) was used to measure pain. Drug dosage was also recorded.
RESULTS


Overall, pain decreased in both arms. However, pain decreased more in the intervention arm as compared to the control arm. The total change in the mean score of the NRS-11 from baseline to follow-up was 3.1 and 6.19 in the control and ST arms, respectively. Differences between pain scores in both arms became significant from day 3 onwards. Mean morphine dose was significantly lower in the intervention arm from day 7 onwards.
LIMITATIONS


The study followed the patients until one week after the last treatment session and encouraged patients to return for treatment if their pain returned to previous levels within 10 days. Moreover, patients in the control arm received the standard of care in the form of pharmacological treatment but did not receive either transcutaneous electrical nerve stimulation (TENS) or a sham (placebo) procedure.
CONCLUSIONS


The trial showed that ST is an effective treatment for the management of pain due to head and neck and thoracic cancer. On the basis of this study, the use of ST for the management of refractory cancer pain in head and neck and thoracic cancer is recommended.",2020,"The total change in the mean score of the NRS-11 from baseline to follow-up was 3.1 and 6.19 in the control and ST arms, respectively.","['Head, Neck and Thoracic Cancer Pain', 'The trial was conducted at the Pain and Palliative Care Unit of the Dr. B.R. Ambedkar Institute Rotary Cancer Hospital of All India Institute of Medical Sciences, New Delhi, India', 'refractory cancer pain in head and neck and thoracic cancer', 'patients suffering from cancer pain', 'Forty patients were included in each of the 2 arms, control and Intervention']","['ST', 'transcutaneous electrical nerve stimulation (TENS) or a sham (placebo) procedure', 'scrambler therapy (ST', 'Scrambler Therapy']","['numeric rating scale (NRS-11', 'Mean morphine dose', 'Overall, pain', 'pain scores', 'pain']","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0153661', 'cui_str': 'Malignant neoplasm of thorax'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0019999', 'cui_str': 'Cancer hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",40.0,0.0368248,"The total change in the mean score of the NRS-11 from baseline to follow-up was 3.1 and 6.19 in the control and ST arms, respectively.","[{'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Kashyap', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sada Nand', 'Initials': 'SN', 'LastName': 'Dwivedi', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, Dr. B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.'}]",Pain physician,[]
2802,32967393,Ashi Acupuncture Versus Local Anesthetic Trigger Point Injections in the Treatment of Abdominal Myofascial Pain Syndrome: A Randomized Clinical Trial.,"BACKGROUND


Chronic pelvic pain (CPP) is defined as recurrent or continuous pain in the lower abdomen or pelvis, non-menstrual or non-cyclic, lasting at least 6 months. There is strong evidence that up to 85% of patients with CPP have serious dysfunction of the musculoskeletal system, including abdominal myofascial syndrome (AMPS). AMPS is characterized as deep abdominal pain, originating from hyperirritable trigger points, usually located within a musculoskeletal range or its fascia of coating. In the literature, there are few studies that address AMPS.
OBJECTIVE


This study aimed to compare the responses of ashi acupuncture treatment and local anesthetic injection in the treatment of chronic pelvic pain secondary to abdominal myofascial pain syndrome in women.
STUDY DESIGN


Randomized controlled clinical trial.
SETTING


Tertiary University Hospital.
METHODS


Women with a clinical diagnosis of CPP secondary to AMPS were randomized and evaluated using instruments to assess clinical pain, namely, the visual analogue scale (VAS), numerical categorial scale (NCS), and the McGill Questionnaire, after receiving treatment with ashi acupuncture (group A, n = 16) or local anesthetic injections (group B, n = 19). They were reevaluated after one week and one, 3, and 6 months after each treatment, in addition to assessments of pain and adverse events performed during the sessions.
RESULTS


Ashi acupuncture and local anesthetic injections were both effective in reducing clinical pain assessed through the analyzed variables among study participants. There was no difference between the groups and there was a strong correlation between these pain assessment instruments.
LIMITATIONS


The absence of blinding to the different forms of treatment among the patients and the researcher directly involved in the treatment, the absence of a placebo group, the selective exclusion of women with comorbidities and other causes of CPP, and the difference between the number of sessions used for each technique.
CONCLUSION


Treatments with ashi acupuncture and local anesthetic injections were effective in reducing clinical pain in women with abdominal myofascial pain syndrome.",2020,"There was no difference between the groups and there was a strong correlation between these pain assessment instruments.
","['Abdominal Myofascial Pain Syndrome', 'chronic pelvic pain secondary to abdominal myofascial pain syndrome in women', 'Women with a clinical diagnosis of CPP secondary to AMPS', 'Tertiary University Hospital', 'women with abdominal myofascial pain syndrome']","['Acupuncture Versus Local Anesthetic Trigger Point Injections', 'acupuncture treatment and local anesthetic injection', 'acupuncture and local anesthetic injections', 'ashi acupuncture', 'local anesthetic injections']","['clinical pain, namely, the visual analogue scale (VAS), numerical categorial scale (NCS', 'pain and adverse events', 'clinical pain']","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0001465', 'cui_str': 'Adenosine phosphate'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0185340', 'cui_str': 'Injection of trigger points'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.156752,"There was no difference between the groups and there was a strong correlation between these pain assessment instruments.
","[{'ForeName': 'Andreia Moreira de Souza', 'Initials': 'AMS', 'LastName': 'Mitidieri', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Maria Carolina Dalla Vecchia', 'Initials': 'MCDV', 'LastName': 'Baltazar', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Ana Paula Moreira', 'Initials': 'APM', 'LastName': 'da Silva', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Maria Beatriz Ferreira', 'Initials': 'MBF', 'LastName': 'Gurian', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Omero Benedicto', 'Initials': 'OB', 'LastName': 'Poli-Neto', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Francisco Jose', 'Initials': 'FJ', 'LastName': 'Candido-Dos-Reis', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Antonio Alberto', 'Initials': 'AA', 'LastName': 'Nogueira', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}, {'ForeName': 'Julio Cesar', 'Initials': 'JC', 'LastName': 'Rosa-E-Silva', 'Affiliation': 'Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo.'}]",Pain physician,[]
2803,32967432,Efficacy of Preoperative Usage of Dexamethasone in Diabetic Patients Undergoing Total Hip or Knee Arthroplasty for Control of Nausea and Vomiting.,"BACKGROUND


Dexamethasone has been used in surgical patients to decrease nausea, vomiting, and postoperative pain. However, it is not well studied how much dexamethasone complicates glucose control in diabetic patients and whether this leads to poor surgical outcomes.
METHODS


We analyzed 256 diabetic patients who underwent elective hip and knee arthroplasty and evaluated the groups that received dexamethasone intraoperatively (201 patients), those who received dexamethasone postoperatively (237 patients), and those who did not receive the steroid intraoperatively (55 patients) and postoperatively (19 patients).
RESULTS


256 diabetic patients were included in the study. The mean age of the group was 68.7 (SD ± 9-10) years. Patients were divided into 123 males (48%) and 133 females (52%). 174 (78%) patients had a total knee replacement operation, and 82 (32%) patients had total hip replacement operation. The mean hemoglobin A1c was 6.728 (SD ± 0.99). The mean ASA score was 2.86 (SD ± 0.38). 201 (78.5%) patients received preoperative or intraoperative dexamethasone, and 237 (92.6%) patients received it postoperatively. The mean blood glucose for all patients raised from 131.9 to 172.2 mg/dL ( P  = .012) postoperatively, 206.1 mg/dL in the first 24 hours, and 146.2 mg/dL ( P  = .39) in the second postoperative day. The change was significant in patients who had poorly controlled diabetes ( P  < .01) preoperatively. There was no significant difference in our study regarding dexamethasone use and effect on postoperative nausea ( P  = 1.0) and vomiting ( P  = .52). There was an improvement in pain scores in the patients who received dexamethasone postoperatively which was statistically significant ( P  = .054).
CONCLUSION


Dexamethasone use in diabetic patients for control of postoperative nausea and vomiting in those undergoing elective total knee and hip arthroplasty had a negative impact on glycemic control specifically in those with poorly controlled diabetes and should be avoided.",2020,"There was an improvement in pain scores in the patients who received dexamethasone postoperatively which was statistically significant ( P  = .054).
","['256 diabetic patients who underwent elective hip and knee arthroplasty and evaluated the groups that received', 'Patients were divided into 123 males (48%) and 133 females (52', '256 diabetic patients', 'diabetic patients', '174 (78%) patients had a total knee replacement operation, and 82 (32%) patients had total hip replacement operation', 'Diabetic Patients Undergoing Total Hip or Knee Arthroplasty for Control of Nausea and Vomiting']","['dexamethasone', 'Dexamethasone', 'preoperative or intraoperative dexamethasone']","['mean blood glucose', 'postoperative nausea', 'mean hemoglobin A1c', 'pain scores', 'mean ASA score', 'vomiting', 'nausea, vomiting, and postoperative pain']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",256.0,0.0218902,"There was an improvement in pain scores in the patients who received dexamethasone postoperatively which was statistically significant ( P  = .054).
","[{'ForeName': 'Tarik J', 'Initials': 'TJ', 'LastName': 'Wasfie', 'Affiliation': 'Department of Surgery and Orthopedic, Ascension Genesys Medical Center, Grand Blanc, MI, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Groton', 'Affiliation': 'Department of Surgery and Orthopedic, Ascension Genesys Medical Center, Grand Blanc, MI, USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Cwalina', 'Affiliation': 'Department of Surgery and Orthopedic, Ascension Genesys Medical Center, Grand Blanc, MI, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Hella', 'Affiliation': 'Department of Academic Research, Ascension Genesys Medical Center, Grand Blanc, MI, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Barber', 'Affiliation': 'Department of Academic Research, Ascension Genesys Medical Center, Grand Blanc, MI, USA.'}]",The American surgeon,['10.1177/0003134820947391']
2804,32967439,The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study: A Pragmatic Randomized Trial.,"BACKGROUND


In-person clinic follow-up within 7 days after discharge from a heart failure hospitalization is associated with lower 30-day readmission. However, health systems and patients may find it difficult to complete an early postdischarge clinic visit, especially during the current pandemic. We evaluated the effect on 30-day readmission and death of follow-up within 7 days postdischarge guided by an initial structured nonphysician telephone visit compared with follow-up guided by an initial clinic visit with a physician.
METHODS AND RESULTS


We conducted a pragmatic randomized trial in a large integrated healthcare delivery system. Adults being discharged home after hospitalization for heart failure were randomly assigned to either an initial telephone visit with a nurse or pharmacist to guide follow-up or an initial in-person clinic appointment with primary care physicians providing usual care within the first 7 days postdischarge. Telephone appointments included a structured protocol enabling medication titration, laboratory ordering, and booking urgent clinic visits as needed under physician supervision. Outcomes included 30-day readmissions and death and frequency and type of completed follow-up within 7 days of discharge. Among 2091 participants (mean age 78 years, 44% women), there were no significant differences in 30-day heart failure readmission (8.6% telephone, 10.6% clinic,  P =0.11), all-cause readmission (18.8% telephone, 20.6% clinic,  P =0.30), and all-cause death (4.0% telephone, 4.6% clinic,  P =0.49). Completed 7-day follow-up was higher in 1027 patients randomized to telephone follow-up (92%) compared with 1064 patients assigned to physician clinic follow-up (79%,  P <0.001). Overall frequency of clinic visits during the first 7 days postdischarge was lower in participants assigned to nonphysician telephone guided follow-up (48%) compared with physician clinic-guided follow-up (77%,  P <0.001).
CONCLUSIONS


Early, structured telephone follow-up after hospitalization for heart failure can increase 7-day follow-up and reduce in-person visits with comparable 30-day clinical outcomes within an integrated care delivery framework.
REGISTRATION


URL: https://www.clinicaltrials.gov; Unique identifier: NCT03524534.",2020,"Completed 7-day follow-up was higher in 1027 patients randomized to telephone follow-up (92%) compared with 1064 patients assigned to physician clinic follow-up (79%,  P <0.001).","['Adults being discharged home after hospitalization for heart failure', '2091 participants (mean age 78 years, 44% women']","['initial telephone visit with a nurse or pharmacist to guide follow-up or an initial in-person clinic appointment with primary care physicians providing usual care within the first 7 days postdischarge', 'initial structured nonphysician telephone visit compared with follow-up guided by an initial clinic visit with a physician']","['30-day readmission and death', 'cause readmission', 'Overall frequency of clinic visits', '30-day heart failure readmission', '30-day readmissions and death and frequency and type of completed follow-up within 7 days of discharge', 'Heart Failure Readmission Intervention']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",2091.0,0.134487,"Completed 7-day follow-up was higher in 1027 patients randomized to telephone follow-up (92%) compared with 1064 patients assigned to physician clinic follow-up (79%,  P <0.001).","[{'ForeName': 'Keane K', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Kaiser Permanente Santa Clara Medical Center, CA (K.K.L., A.S.).'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Thomas', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}, {'ForeName': 'Thida C', 'Initials': 'TC', 'LastName': 'Tan', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}, {'ForeName': 'Thomas K', 'Initials': 'TK', 'LastName': 'Leong', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Steimle', 'Affiliation': 'Department of Cardiology, Kaiser Permanente Santa Clara Medical Center, CA (K.K.L., A.S.).'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Go', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, CA (K.K.L., R.C.T., T.C.T., T.K.L., A.S.G.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.120.006553']
2805,32967450,"A Single Centre Prospective Comparative Study of Two Single Use Flexible Ureteroscopes - LithoVue (Boston Scientific, USA) And Uscope PU3022a (Zhuhai Pusen, China).","INTRODUCTION AND OBJECTIVE


Single-use flexible ureteroscopes have benefit of decreasing infection transmission, avoiding sterilization need and no maintenance cost. Primary objective was to compare in-vivo performance and surgical outcomes with two single-use ureteroscopes: LithoVue (Boston Scientific, USA) and Uscope PU3022A (Pusen, Zhuhai, China) PU3022a with secondary objective being to compare in-vivo vision by independent endourologist blinded to scope manufacturer.
METHODS


50 patients undergoing RIRS with <2cm renal stones, were prospectively allocated: Group 1 (25 patients) for LithoVue and group 2 (25 patients) for Uscope. Pre-, intra- and postoperative parameters were evaluated. Vision of both scopes with and without accessory was evaluated by an independent endourologist, blinded to make of scope. Stone clearance was assessed with X-ray KUB and USG KUB at one month. Students' t-test for quantitative and chi-square for categorical data used.
RESULTS


Pre- and intra-operative parameters like need for ureteral dilatation(p>0.05), ureteral access-sheath size (p=0.78), accessibility to pelvicalyceal system(p>0.05) and manoeuvrability(p>0.05) were comparable in both groups. Lower-pole access was possible in all cases of LithoVue, slightly difficult in 3 cases of Uscope(p>0.5). Intraoperative vision was hazy in 4 cases of LithoVue and 8 cases of Uscope (p=0.32) during lasing along with 3 cases of Uscope with accessory (p=0.24). Blinded endourologist reported more cases of hazy vision with or without accessory or lasing in Uscope arm (p>0.05). One device had malfunction in LithoVue arm. Complete stone clearance achieved in all cases at 1 month.
CONCLUSIONS


We conclude that performance of these two single-use scopes, LithoVue and Uscope is comparable in clinical settings with similar clinical outcomes and complications.",2020,Intraoperative vision was hazy in 4 cases of LithoVue and 8 cases of Uscope (p=0.32) during lasing along with 3 cases of Uscope with accessory (p=0.24).,['50 patients undergoing RIRS with <2cm renal stones'],"['two single-use ureteroscopes: LithoVue (Boston Scientific, USA) and Uscope PU3022A (Pusen, Zhuhai, China) PU3022a', 'Flexible Ureteroscopes - LithoVue']","['vivo performance and surgical outcomes', 'Complete stone clearance', 'Stone clearance', 'Intraoperative vision']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0184213', 'cui_str': 'Ureteroscope'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0392306', 'cui_str': 'Flexible ureteroscope'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",50.0,0.0557162,Intraoperative vision was hazy in 4 cases of LithoVue and 8 cases of Uscope (p=0.32) during lasing along with 3 cases of Uscope with accessory (p=0.24).,"[{'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Patil', 'Affiliation': 'Muljibhai Patel Urological Hospital, 29025, Urology, Muljibhai Patel Urological Hospital, V V Desai Road, Nadiad, India, 387001; dr.abhip@gmail.com.'}, {'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Muljibhai Patel Urological Hospital, 29025, Nadiad, Gujarat, India; shank789agrawal@gmail.com.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Muljibhai Patel Urological Hospital, 29025, Urology, Nadiad, Gujarat, India; drabhisheksingh82@gmail.com.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Ganpule', 'Affiliation': 'Muljibhai Patel Urological Hospital, 29025, Department of Urology, Nadiad, Gujarat, India; doctorarvind1@gmail.com.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Sabnis', 'Affiliation': 'Muljibhai Patel Urological Hospital, 29025, Urology, Nadiad, Gujarat, India; rbsabnis@gmail.com.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Muljibhai Patel Urological Hospital, 29025, Urology, Nadiad, Gujarat, India; mrdesai@mpuh.org.'}]",Journal of endourology,['10.1089/end.2020.0409']
2806,32967467,See Like an Expert: Gaze-Augmented Training Enhances Skill Acquisition in a Virtual Reality Robotic Suturing Task.,"INTRODUCTION


The da Vinci skills simulator (DVSS) is an effective platform for robotic skills training. Novel training methods using expert gaze patterns to guide trainees have demonstrated superiority to traditional instruction. Portable head-mounted eye-trackers (HMET) offer the opportunity for eye tracking technology to enhance surgical robotic simulation training.
OBJECTIVE


To evaluate if training guided by expert gaze patterns can improve trainee performance over standard movement training techniques during robotic simulation.
METHODS


Medical students were recruited and randomized into gaze training (GT, n=9) and movement training (MT, n=8) groups. First, the participants reviewed an instructional video, GT group emulating expert gaze patterns and the MT group (n=8) standard movement-based instruction. Training consisted of ten repetitions of ""Suture Sponge 3"" on the DVSS while wearing HMET; the first three repetitions were followed by group-appropriate video coaching (gaze vs. movement feedback) while the remaining repetitions were without feedback. Finally, two multitasking repetitions with a secondary bell-counting task were completed. Primary outcomes included DVSS scores during training and multitasking. Secondary outcomes included metrics collected from the HMET (gaze patterns and gaze entropy).
RESULTS


Total score, efficiency, and penalties improved significantly over the training in both groups; the GT group achieved higher scores on every attempt. Total scores in the GT group were higher than the MT group post-video review (20.3±21.8 vs. 3.0±6.2, p=0.047), after coaching repetitions (61.8±18.8 vs 30.1±26.2, p=0.01), and at the last training attempt (73.0±16.5 vs. 63.1±17.4, p = 0.247). During multitasking, the GT group maintained higher total scores (75±10.1 vs. 63.3±15.3, p=0.01), efficiency (86.3±7.4 vs. 77.4±11.2, p=0.009), and superior secondary task performance (error: 6.3%±0.06 vs 10.7%±0.11, p=0.20). Gaze entropy (cognitive-load indicator) and gaze pattern analysis showed similar trends.
CONCLUSION


Gaze-augmented training leads to more efficient movements through adoption of expert gaze patterns that withstand additional stressors.",2020,"During multitasking, the GT group maintained higher total scores (75±10.1 vs. 63.3±15.3, p=0.01), efficiency (86.3±7.4 vs. 77.4±11.2, p=0.009), and superior secondary task performance (error: 6.3%±0.06 vs 10.7%±0.11, p=0.20).",['Medical students'],"['Expert: Gaze-Augmented Training Enhances Skill Acquisition', 'da Vinci skills simulator (DVSS', 'Portable head-mounted eye-trackers (HMET', 'training guided by expert gaze patterns', 'Suture Sponge 3"" on the DVSS while wearing HMET; the first three repetitions were followed by group-appropriate video coaching (gaze vs. movement feedback) while the remaining repetitions were without feedback', 'instructional video, GT group emulating expert gaze patterns and the MT group (n=8) standard movement-based instruction', 'gaze training (GT, n=9) and movement training']","['Gaze entropy (cognitive-load indicator) and gaze pattern analysis', 'Total scores', 'DVSS scores during training and multitasking', 'total scores', 'metrics collected from the HMET (gaze patterns and gaze entropy', 'superior secondary task performance', 'Total score, efficiency, and penalties', 'efficiency', 'trainee performance']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0181909', 'cui_str': 'Mount'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0032699', 'cui_str': 'Phylum Porifera'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0181909', 'cui_str': 'Mount'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0369999,"During multitasking, the GT group maintained higher total scores (75±10.1 vs. 63.3±15.3, p=0.01), efficiency (86.3±7.4 vs. 77.4±11.2, p=0.009), and superior secondary task performance (error: 6.3%±0.06 vs 10.7%±0.11, p=0.20).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Melnyk', 'Affiliation': 'University of Rochester Medical Center, 6923, Urology, Rochester, New York, United States; Rachel_melnyk@urmc.rochester.edu.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Campbell', 'Affiliation': 'University of Rochester Medical Center, 6923, Urology, Rochester, New York, United States; Timothy_Campbell@URMC.Rochester.edu.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Holler', 'Affiliation': 'University of Rochester Medical Center, 6923, Urology, Rochester, New York, United States; Tyler_holler@urmc.rochester.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Cameron', 'Affiliation': 'University of Rochester Medical Center, 6923, Urology, Rochester, New York, United States; kxc6643@rit.edu.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Saba', 'Affiliation': 'University of Rochester Medical Center, 6923, Urology, 601 Elmwood Ave, Rochester, Rochester, New York, United States, 14642; Patrick_Saba@urmc.rochester.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Witthaus', 'Affiliation': 'University of Rochester Medical Center, 6923, Urology, Rochester, New York, United States; Michael_Witthaus@urmc.rochester.edu.'}, {'ForeName': 'Jean Volny', 'Initials': 'JV', 'LastName': 'Joseph', 'Affiliation': 'University of Rochester Medical Center, Urology , 601 Elmwood Avenue, Box 656, Rochester, New York, United States, 14642; jean_joseph@urmc.rochester.edu.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Ghazi', 'Affiliation': 'University of Rochester Medical Center, Urology , 400S White Spruce Blv, Rochester, New York, United States, 14642; ahmed_ghazi@urmc.rochester.edu.'}]",Journal of endourology,['10.1089/end.2020.0445']
2807,32967598,Prophylactic Wound Drainage in Renal Transplant: A Survey of Practice Patterns in Australia and New Zealand.,"OBJECTIVES


Drains are used routinely in many centers at the conclusion of kidney transplant, despite a paucity of evidence to guide practice in kidney transplant. Studies have not shown benefit from prophylactic drain placement following other major abdominal and vascular operations, and usage is consequently declining. Our aim was to understand practice patterns and rationale for behavior in drain placement and management in kidney transplant.
MATERIALS AND METHODS


We conducted an online survey of surgeons who routinely perform kidney transplants across Australia and New Zealand.
RESULTS


The response rate was 66% (43/66). Of respondents, 61% reported routine drain insertion, whereas 21% seldom inserted drains. Concerns about bleeding and anticoagulation (63%) and routine practice (58%) were the dominant reasons for drain insertion. The factors selected as most significant in determining drain removal were both volume and time (44%) and volume alone (33%). A volume of ⟨ 50 mL/day (51%) was the most commonly reported threshold for removal. The postoperative period of days 3 to 5 was the most commonly selected time point for drain removal (63%). Seventy-four percent of respondents would consider enrolling their patients in a randomized controlled trial to determine the benefits and harms of drain insertion.
CONCLUSIONS


Although drain insertion is a common practice, transplant surgeons in Australia and New Zealand reported sufficient uncertainty concerning the potential benefits and harms to warrant design and conduct of a randomized controlled trial.",2020,Concerns about bleeding and anticoagulation (63%) and routine practice (58%) were the dominant reasons for drain insertion.,"['A Survey of Practice Patterns in Australia and New Zealand', 'We conducted an online survey of surgeons who routinely perform kidney transplants across Australia and New Zealand', 'Renal Transplant']","['prophylactic drain placement', 'Prophylactic Wound Drainage', 'drain insertion']","['response rate', 'drain removal', 'routine drain insertion']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}, {'cui': 'C0406834', 'cui_str': 'Wound discharge finding'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.268058,Concerns about bleeding and anticoagulation (63%) and routine practice (58%) were the dominant reasons for drain insertion.,"[{'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Mugino', 'Affiliation': 'From the Royal Prince Alfred Hospital Institute of Academic Surgery, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Lam', 'Affiliation': ''}, {'ForeName': 'Ahmer', 'Initials': 'A', 'LastName': 'Hameed', 'Affiliation': ''}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Sandroussi', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Chadban', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pleass', 'Affiliation': ''}, {'ForeName': 'Jerome Martin', 'Initials': 'JM', 'LastName': 'Laurence', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2020.0071']
2808,32967605,"Self-Care Education Program as a New Pathway Toward Improving Quality of Life in Kidney Transplant Patients: A Single-Blind, Randomized, Controlled Trial.","OBJECTIVES


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


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


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


A self-care education program is a more effective approach to improve the knowledge and skills of transplant patients. Thus, we suggest an emphasis on teaching self-care knowledge and skills for transplant patients in nursing care education programs. This can ultimately lead to quality of life improvement in kidney transplant patients.",2020,A significant difference was observed in the mean score of quality of life between both groups after intervention (P ⟨ .001).,"['kidney transplant patients', 'Kidney Transplant Patients', 'transplant patients', '59 patients who met inclusion criteria were selected using a convenience sampling technique', 'transplant patients in nursing care education programs']","['self-care education program', 'bedside self-care education program', 'routine care']","['Quality of Life', 'quality of life', 'mean score of quality of life']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",59.0,0.0337106,A significant difference was observed in the mean score of quality of life between both groups after intervention (P ⟨ .001).,"[{'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Aghakhani', 'Affiliation': 'From the Patient Safety Research Center, Nursing and Midwifery Faculty, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Masumeh', 'Initials': 'M', 'LastName': 'Hemmati Maslakpak', 'Affiliation': ''}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Jalali', 'Affiliation': ''}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Parizad', 'Affiliation': ''}]",Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation,['10.6002/ect.2020.0044']
2809,32967616,Underwater versus conventional endoscopic mucosal resection for small size non-pedunculated colorectal polyps: a randomized controlled trial : (UEMR vs. CEMR for small size non-pedunculated colorectal polyps).,"BACKGROUND


Underwater endoscopic mucosal resection (UEMR) is a recently developed technique and can be performed during water-aided or ordinary colonoscopy for the treatment of colorectal polyps. The objective of this clinical trial was to evaluate the efficacy and safety of UEMR in comparison with conventional endoscopic mucosal resection (CEMR) of small non-pedunculated colorectal polyps.
METHODS


Patients with small size, non-pedunculated colorectal polyps (4-9 mm in size) who underwent colonoscopic polypectomy were enrolled in this multicenter randomized controlled clinical trial. The patients were randomly allocated to two groups, an UEMR group and a CEMR group. Efficacy and safety were compared between groups.
RESULTS


In the intention-to-treat (ITT) analysis, the complete resection rate was 83.1% (59/71) in the UEMR group and 87.3% (62/71) in the CEMR group. The en-bloc resection rate was 94.4% (67/71) in the UEMR group and 91.5% (65/71) in the CEMR group (difference 2.9%; 90% CI - 4.2 to 9.9%), showed noninferiority (noninferiority margin - 5.7% < - 4.2%). No significant difference in procedure time (81 s vs. 72 s, P = 0.183) was observed. Early bleeding was observed in 1.4% of patients in the CEMR group (1/71) and 1.4% of patients in the UEMR group (1/71). None of the patients in the UEMR group complained of postprocedural bloody stool, whereas two patients in the CEMR group (2/64) reported this adverse event.
CONCLUSION


Our results indicate that UEMR is safer and just as effective as CEMR in En-bloc resection for the treatment of small colorectal polyps as such, UEMR is recommended as an alternative approach to excising small and non-pedunculated colorectal adenomatous polyps.
TRIAL REGISTRATION


Clinical Trials.gov, NCT03833492 . Retrospectively registered on February 7, 2019.",2020,"No significant difference in procedure time (81 s vs. 72 s, P = 0.183) was observed.","['Patients with small size, non-pedunculated colorectal polyps (4-9\u2009mm in size) who underwent', 'small size non-pedunculated colorectal polyps']","['Underwater versus conventional endoscopic mucosal resection', 'UEMR', 'CEMR', 'Underwater endoscopic mucosal resection (UEMR', 'conventional endoscopic mucosal resection (CEMR', 'colonoscopic polypectomy']","['efficacy and safety', 'en-bloc resection rate', 'Early bleeding', 'postprocedural bloody stool', 'Efficacy and safety', 'procedure time', 'complete resection rate', 'adverse event']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1700928', 'cui_str': 'Strip Biopsy'}, {'cui': 'C0589347', 'cui_str': 'Colonoscopic polypectomy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.062598,"No significant difference in procedure time (81 s vs. 72 s, P = 0.183) was observed.","[{'ForeName': 'Zhixin', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'College of Medicine, Ningbo University, Ningbo, 315211, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Gastroenterology, Ninghai Second Hospital, Ningbo, 315600, China.'}, {'ForeName': 'Hongyao', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Department of Gastroenterology, Haishu Second Hospital, Ningbo, 315000, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'College of Medicine, Ningbo University, Ningbo, 315211, China.'}, {'ForeName': 'Chunnian', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Ningbo Clinical and Pathological Diagnosis Center, Ningbo, 315021, China.'}, {'ForeName': 'Jiarong', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'College of Medicine, Ningbo University, Ningbo, 315211, China.'}, {'ForeName': 'Yarong', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': 'Department of Gastroenterology, Ninghai Second Hospital, Ningbo, 315600, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Ningbo First Hospital, Ningbo, 315010, China. nbdyyywhw@163.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, Ningbo First Hospital, Ningbo, 315010, China. xulei22@163.com.'}]",BMC gastroenterology,['10.1186/s12876-020-01457-y']
2810,32967619,Advance care planning with people with dementia: a process evaluation of an educational intervention for general practitioners.,"BACKGROUND


General practitioners (GPs) are advised to offer advance care planning (ACP) to people with dementia (PWD). In a randomized controlled trial, an educational intervention for GPs aimed at initiating and optimizing ACP proved to be effective. During the intervention most GPs were accompanied by their practice nurse (PN). To provide insights into the intervention's successful components and what could be improved, we conducted a process evaluation and explored implementation, mechanisms of impact and contextual factors.
METHODS


We used the Medical Research Council guidance for process evaluations. Implementation was explored identifying reach and acceptability. We performed descriptive analyses of participants' characteristics; selection, inclusion and intervention attendance; a GP post-intervention survey on initiating ACP; a post intervention focus group with trainers of the intervention. Mechanisms of impact were explored identifying adoption and appropriateness. We used: participants' intervention ratings; a GP post-intervention survey on conducting ACP; ACP documentation in PWD's medical files; post-intervention interviews with PWD/FC dyads. All data was used to identify contextual factors.
RESULTS


The intervention was implemented by a small percentage of the total Dutch GP population invited, who mostly included motivated PWD/FC dyads with relatively little burden, and PWD with limited cognitive decline. The mechanisms of impact for GPs were: interactively learning to initiate ACP with training actors with a heterogeneous group of GPs and PNs. For PWD/FCs dyads, discussing non-medical preferences was most essential regarding their SDM experience and QoL. Some dyads however found ACP stressful and not feasible. Younger female GPs more often initiated ACP. Male PWD and those with mild dementia more often had had ACP. These characteristics and the safe and intimate training setting, were important contextual facilitators.
CONCLUSION


We recommend Interventions aimed at improving ACP initiation with PWD by GPs to include interactive components and discussion of non-medical preferences. A safe environment and a heterogeneous group of participants facilitates such interventions. However, in practice not all FC/PWD dyads will be ready to start. Therefore, it is necessary to check their willingness when ACP is offered.",2020,"For PWD/FCs dyads, discussing non-medical preferences was most essential regarding their SDM experience and QoL.","['people with dementia', 'general practitioners', 'Male PWD and those with mild dementia more often had had ACP', 'total Dutch GP population invited, who mostly included motivated PWD/FC dyads with relatively little burden, and PWD with limited cognitive decline', 'people with dementia (PWD']","['educational intervention', 'GP post-intervention survey on initiating ACP', 'Advance care planning', ""GP post-intervention survey on conducting ACP; ACP documentation in PWD's medical files; post-intervention interviews with PWD/FC dyads""]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]",[],,0.0454545,"For PWD/FCs dyads, discussing non-medical preferences was most essential regarding their SDM experience and QoL.","[{'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Tilburgs', 'Affiliation': 'Department of IQ Healthcare, Radboudumc, Nijmegen, The Netherlands. Bram.Tilburgs@radboudumc.nl.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Koopmans', 'Affiliation': 'Department of primary and community care, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Schers', 'Affiliation': 'Department of primary and community care, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Carolien', 'Initials': 'C', 'LastName': 'Smits', 'Affiliation': 'Research Group Innovating with Older Adults, Windesheim University of Applied Sciences, Zwolle, The Netherlands.'}, {'ForeName': 'Myrra', 'Initials': 'M', 'LastName': 'Vernooij-Dassen', 'Affiliation': 'Department of IQ Healthcare, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Perry', 'Affiliation': 'Department of primary and community care, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Engels', 'Affiliation': 'Department of anesthesiology, pain and palliative medicine, Radboudumc, Nijmegen, The Netherlands.'}]",BMC family practice,['10.1186/s12875-020-01265-z']
2811,32967637,Clinical practice guideline on the prevention and management of neonatal extravasation injury: a before-and-after study design.,"BACKGROUND


Extravasation injury resulting from intravenous therapies delivered via peripheral intravenous catheters or umbilical and peripherally inserted central venous catheters is a common iatrogenic complication occurring in neonatal intensive care units. This study aimed to evaluate the effectiveness of an evidence-based clinical practice guideline in the prevention and management of neonatal extravasation injury by nurses.
METHODS


A controlled before-and-after study was conducted in a neonatal unit. The clinical practice guideline was developed, and a multifaceted educational program was delivered to nurses. Neonatal outcomes, including the rates of peripheral intravenous extravasation and extravasation from a central line, were collected at the pre- and post-intervention periods. Post-intervention data for nurses, including the nurses' level of knowledge and adherence, were collected at six months after the program.
RESULTS


104 and 109 neonates were recruited in the pre-intervention period (control) and the post-intervention period (intervention), respectively. The extravasation rate before and after the intervention was 14.04 and 2.90 per 1,000 peripheral intravenous catheters days, respectively. The adjusted odds ratio of peripheral intravenous extravasation post-intervention compared with that of pre-intervention was 0.20 (95% confidence interval: 0.05-0.74; p = 0.02) after adjusting for peripheral intravenous catheter days. The extravasation from a central line rate of the control and intervention groups post-intervention was 4.94 and zero per 1,000 central venous catheter days, respectively. Fifty-nine registered nurses were recruited. At six months post-program, there were significant improvements in the nurses' level of knowledge and adherence.
CONCLUSIONS


These findings suggest that the implementation of an evidence-based clinical practice guideline significantly reduced the rate of peripheral intravenous extravasation and extravasation from a central line in neonates. However, to maintain nurses' knowledge and adherence to the evidence-based practice, the educational program will have to be conducted periodically and incorporated into the nurses' induction program.
TRIAL REGISTRATION


ClinicalTrials.gov, Identifiers: NCT04321447 . Registered 20 March 2020 - Retrospectively registered.",2020,"The extravasation from a central line rate of the control and intervention groups post-intervention was 4.94 and zero per 1,000 central venous catheter days, respectively.","['104 and 109 neonates were recruited in the pre-intervention period (control) and the post-intervention period (intervention), respectively', 'neonatal extravasation injury by nurses', 'Fifty-nine registered nurses were recruited']",[],"['extravasation rate', 'rate of peripheral intravenous extravasation and extravasation', ""nurses' level of knowledge and adherence"", 'rates of peripheral intravenous extravasation and extravasation from a central line']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1299641', 'cui_str': 'Extravasation injury'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}]",[],"[{'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}]",,0.0774775,"The extravasation from a central line rate of the control and intervention groups post-intervention was 4.94 and zero per 1,000 central venous catheter days, respectively.","[{'ForeName': 'Kam Ming', 'Initials': 'KM', 'LastName': 'Chan', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, United Christian Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Janita Pak Chun', 'Initials': 'JPC', 'LastName': 'Chau', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong. janitachau@cuhk.edu.hk.'}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong.'}, {'ForeName': 'Genevieve Po Gee', 'Initials': 'GPG', 'LastName': 'Fung', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, United Christian Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Wai Wa', 'Initials': 'WW', 'LastName': 'Lui', 'Affiliation': 'Pharmacy Department, United Christian Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Meme Suk Ying', 'Initials': 'MSY', 'LastName': 'Chan', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, United Christian Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Suzanne Hoi Shan', 'Initials': 'SHS', 'LastName': 'Lo', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong.'}]",BMC pediatrics,['10.1186/s12887-020-02346-9']
2812,32967638,A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial.,"BACKGROUND


In order to achieve improved weight status, behavioral pediatric obesity treatment is resource intensive. Mobile Health (mHealth) is more accessible than standard care but effective approaches are scarce. Therefore, the aim of this feasibility trial was to study trial design, mHealth usage, compliance, and acceptability of a novel mHealth approach in pediatric obesity treatment.
METHODS


This six-month parallel two-arm feasibility trial took place at three pediatric outpatient clinics in Stockholm, Sweden. Participants, 5-12 years, starting obesity treatment were randomized to using an mHealth support system as an addition to standard care (intervention) or to standard care alone (control). The intervention included daily self-monitoring of weight transferred to a mobile application (app) used by parents, a website in which clinicians could track treatment progress, prespecified treatment goals for change in degree of obesity shown in the app and on the website, and text message interactions between clinicians and parents. The main outcome was description of feasibility. Height and weight were measured at baseline, three, and 6 months to explore changes in body mass index standard deviation score (BMI SDS).
RESULTS


Of 40 children eligible for inclusion, 28 agreed to participate (54% girls) and were randomized to intervention (n = 15) or control (n = 13). Weight was measured at home regularly throughout the entire trial period by 12/15 children in the intervention group. Attendance at appointments were better in the intervention group (p = 0.024). Both parents and clinicians had a positive experience and found the mHealth support system accessible. At 6 months the intervention group had a greater reduction of 0.24 units in BMI SDS than standard care (- 0.23 vs. 0.01, p = 0.002).
CONCLUSIONS


The mHealth support system was a feasible and innovative treatment approach which, in addition to standard care, generated better treatment results than standard care alone. Future research should evaluate the treatment effects over a longer follow-up time in a larger study sample.
TRIAL REGISTRATION


This trial was retrospectively registered at ClinicalTrials.gov , ID: NCT03380598 , on November 8, 2017.",2020,Attendance at appointments were better in the intervention group (p = 0.024).,"['Participants, 5-12\u2009years, starting obesity treatment', 'pediatric outpatient clinics in Stockholm, Sweden', '40 children eligible for inclusion, 28 agreed to participate (54% girls', 'pediatric obesity treatment']","['novel interactive mobile health support system', 'mHealth support system as an addition to standard care (intervention) or to standard care alone (control']","['body mass index standard deviation score (BMI SDS', 'BMI SDS', 'Height and weight', 'Weight']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0748877', 'cui_str': 'Social Support System'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",40.0,0.118951,Attendance at appointments were better in the intervention group (p = 0.024).,"[{'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Johansson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Division of Pediatrics, Karolinska Institutet, CLINTEC, Novum, Blickagangen 6A, 141 57, Huddinge, Sweden.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Hagman', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Division of Pediatrics, Karolinska Institutet, CLINTEC, Novum, Blickagangen 6A, 141 57, Huddinge, Sweden.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Danielsson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Division of Pediatrics, Karolinska Institutet, CLINTEC, Novum, Blickagangen 6A, 141 57, Huddinge, Sweden. pernilla.danielsson.liljeqvist@ki.se.'}]",BMC pediatrics,['10.1186/s12887-020-02338-9']
2813,32967646,Protocol of a randomized controlled trial to test the effects of client-centered Representative Payee Services on antiretroviral therapy adherence among marginalized people living with HIV.,"BACKGROUND


Client-Centered Representative Payee (CCRP) is an intervention modifying implementation of a current policy of the US Social Security Administration, which appoints organizations to serve as financial payees on behalf of vulnerable individuals receiving Social Security benefits. By ensuring beneficiaries' bills are paid while supporting their self-determination, this structural intervention may mitigate the effects of economic disadvantage to improve housing and financial stability, enabling self-efficacy for health outcomes and improved antiretroviral therapy adherence. This randomized controlled trial will test the impact of CCRP on marginalized people living with HIV (PLWH). We hypothesize that helping participants to pay their rent and other bills on time will improve housing stability and decrease financial stress.
METHODS


PLWH (n = 160) receiving services at community-based organizations will be randomly assigned to the CCRP intervention or the standard of care for 12 months. Fifty additional participants will be enrolled into a non-randomized (""choice"") study allowing participant selection of the CCRP intervention or control. The primary outcome is HIV medication adherence, assessed via the CASE adherence index, viral load, and CD4 counts. Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months. Viral load, CD4, and appointment adherence data will be collected at baseline, 6, 12, 18, and 24 months from medical records. Outcomes will be compared by treatment group in the randomized trial, in the non-randomized cohort, and in the combined cohort. Qualitative data will be collected from study participants, eligible non-participants, and providers to explore underlying mechanisms of adherence, subjective responses to the intervention, and implementation barriers and facilitators.
DISCUSSION


The aim of this study is to determine if CCRP improves health outcomes for vulnerable PLWH. Study outcomes may provide information about supports needed to help economically fragile PLWH improve health outcomes and ultimately improve HIV health disparities. In addition, findings may help to refine service delivery including the provision of representative payee to this often-marginalized population. This protocol was prospectively registered on May 22, 2018 with ClinicalTrials.gov (NCT03561103) .",2020,"Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months.","['Fifty additional participants', 'PLWH (n\u2009', 'marginalized people living with HIV (PLWH', '160) receiving services at community-based organizations', 'marginalized people living with HIV']","['CCRP intervention or control', 'Client-Centered Representative Payee (CCRP', 'CCRP', 'client-centered Representative Payee Services', 'CCRP intervention']","['antiretroviral therapy adherence', 'HIV health disparities', 'ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care', 'Viral load, CD4, and appointment adherence data', 'HIV medication adherence, assessed via the CASE adherence index, viral load, and CD4 counts']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",,0.254784,"Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months.","[{'ForeName': 'Abisola', 'Initials': 'A', 'LastName': 'Olaniyan', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, 130 De Soto Street, 6120 Public Health, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Creasy', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, 130 De Soto Street, 6120 Public Health, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'Department of Social Work, College of Arts and Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Maria Mori', 'Initials': 'MM', 'LastName': 'Brooks', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maulsby', 'Affiliation': 'Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Musgrove', 'Affiliation': 'Birmingham AIDS Outreach, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hagan', 'Affiliation': 'Action Wellness, Philadelphia, PA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Courtenay', 'Initials': 'C', 'LastName': 'Sashin', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Farmartino', 'Affiliation': 'The Open Door, Inc., Pittsburgh, PA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hawk', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, 130 De Soto Street, 6120 Public Health, Pittsburgh, PA, 15261, USA. meh96@pitt.edu.'}]",BMC public health,['10.1186/s12889-020-09500-z']
2814,32967663,"Correction to: Evaluation of the impact of breastfeeding support groups in primary health centres in Andalusia, Spain: a study protocol for a cluster randomized controlled trial (GALMA project).",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,"['primary health centres in Andalusia, Spain']",[],[],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],[],,0.0915398,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Rodríguez-Gallego', 'Affiliation': 'Virgen del Rocío University Hospital (Seville), Centro Universitario de Enfermería Cruz Roja, University of Seville, Sevilla, Spain.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Leon-Larios', 'Affiliation': 'Nursing Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Sevilla, Spain. fatimaleon@us.es.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Ruiz-Ferron', 'Affiliation': 'Nursing Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Sevilla, Spain.'}, {'ForeName': 'Maria-de-Las-Mercedes', 'Initials': 'MD', 'LastName': 'Lomas-Campos', 'Affiliation': 'Nursing Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Sevilla, Spain.'}]",BMC public health,['10.1186/s12889-020-09528-1']
2815,32967685,"Lung function, pharmacokinetics, and tolerability of inhaled indacaterol maleate and acetate in asthma patients.","BACKGROUND


Indacaterol maleate delivered with the Breezhaler® inhalation device is a long-acting β 2 -agonist approved for chronic obstructive pulmonary disease. In the development of a once daily, inhaled fixed dose combination (FDC) of indacaterol, glycopyrronium bromide (a long-acting muscarinic antagonist), and mometasone furoate (an inhaled corticosteroid [ICS]) for the treatment of patients with asthma, the acetate salt of indacaterol is used instead of the maleate salt. Here, we investigated the lung function, pharmacokinetics (PK) and safety of indacaterol maleate 150 μg once daily (o.d.) and indacaterol acetate 150 μg o.d. in comparison with placebo.
METHODS


This was a randomised, double-blind, three-period crossover study (ClinicalTrials.gov identifier, NCT03257995) in patients with asthma on background ICS therapy. Patients with percent predicted pre-bronchodilator forced expiratory volume per second (FEV 1 ) ≥50% and ≤ 90% were included in the study. Patients received indacaterol maleate 150 μg o.d., indacaterol acetate 150 μg o.d., or placebo on top of stable background ICS in randomised sequence. Trough FEV 1  was assessed after 14 days of treatment. PK of indacaterol salts were assessed at steady state after 14 days of treatment; peak expiratory flow (PEF) rate and rescue medication use were collected with a combined PEF-meter/electronic diary throughout the study.
RESULTS


Of the 54 adult patients (median age of 48 years), 51 patients completed the study. Both indacaterol salts demonstrated statistically significant improvements in trough FEV 1  of 186 mL (maleate) and 146 mL (acetate) compared with placebo (both P < 0.001). FEV 1  AUC 0-4h  improved by 248 mL (maleate) and 245 mL (acetate), and PEF by 33 L/min (maleate) and 30.8 L/min (acetate) versus placebo. Systemic exposure of indacaterol (AUC 0-24h,ss  and C max,ss  on Day 14) was comparable after administration of both salt forms. Both salt forms demonstrated a good safety profile and were well tolerated, with a difference in the reporting frequency of AEs of coughing (maleate, 23.5%; acetate, 0%).
CONCLUSIONS


In patients with asthma, indacaterol maleate and acetate elicited comparable and significant improvements in lung function compared with placebo and achieved comparable systemic exposure. Both indacaterol salts were safe and well tolerated.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03257995 June 06, 2017.",2020,"Both salt forms demonstrated a good safety profile and were well tolerated, with a difference in the reporting frequency of AEs of coughing (maleate, 23.5%; acetate, 0%).
","['Patients with percent predicted pre-bronchodilator forced expiratory volume per second (FEV 1 ) ≥50% and\u2009≤\u200990% were included in the study', 'asthma patients', 'patients with asthma on background ICS therapy', 'patients with asthma, the acetate salt of', '51 patients completed the study', '54 adult patients (median age of 48\u2009years']","['indacaterol salts', 'inhaled fixed dose combination (FDC) of indacaterol, glycopyrronium bromide', 'mometasone furoate', 'placebo', 'PK of indacaterol salts', 'indacaterol maleate', 'indacaterol acetate 150\u2009μg o.d', 'corticosteroid [ICS', 'indacaterol acetate 150\u2009μg o.d., or placebo', 'indacaterol', 'inhaled indacaterol maleate and acetate', 'Indacaterol maleate']","['peak expiratory flow (PEF) rate and rescue medication use', 'Lung function, pharmacokinetics, and tolerability', 'trough FEV', 'lung function', 'safe and well tolerated', 'lung function, pharmacokinetics (PK) and safety', 'Trough FEV 1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0565930', 'cui_str': '/second'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2920417', 'cui_str': 'Indacaterol maleate'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",54.0,0.52267,"Both salt forms demonstrated a good safety profile and were well tolerated, with a difference in the reporting frequency of AEs of coughing (maleate, 23.5%; acetate, 0%).
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Northeast Medical Research Associates Inc., North Dartmouth, MA, USA.'}, {'ForeName': 'Soniya', 'Initials': 'S', 'LastName': 'Vaidya', 'Affiliation': 'Axcella Health, Cambridge, MA, USA.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Jauernig', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ethell', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Wagner', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Rajkumar', 'Initials': 'R', 'LastName': 'Radhakrishnan', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Tillmann', 'Affiliation': 'Novartis Institutes for Biomedical Research, Basel, Switzerland. hanns-christian.tillmann@novartis.com.'}]",Respiratory research,['10.1186/s12931-020-01501-1']
2816,32975909,Effects of dehydroepiandrosterone on quality of life in premenopausal women with rheumatoid arthritis: A preliminary randomized clinical trial.,"AIM


Chronic inflammation and subsequent use of glucocorticoids can lead to relative adrenocortical insufficiency in patients with rheumatoid arthritis (RA). Previously, adrenocortical hormone, dehydroepiandrosterone (DHEA) was shown as a potential therapy for autoimmune disorders. However, data regarding effects of DHEA in RA are limited. The aim of this study was to investigate the effects of DHEA on quality of life (QOL) in premenopausal rheumatoid arthritis patients.
METHOD


In this randomized double blinded, controlled trial 46 premenopausal rheumatoid arthritis patients were assigned to receive 50 mg/d DHEA (23 patients) or placebo (23 patients) for 12 weeks. Disease Activity Score of 28 joints - erythrocyte sedimentation rate (DAS28-ESR) questionnaire, visual analog score and swollen and tender joint counts (both 0-28) were used for assessment of disease activity. Persian-validated World Health Organization Quality of Life Brief version (WHOQOL BREF) questionnaire was used to assess quality of life.
RESULTS


In comparison to the control group more improvement in QOL (P = .025) and environment health (P = .001) was observed in the DHEA group. After adjustment for age and disease duration DHEA was associated with more improvement in QOL (P = .01), psychological (P = .02) and physical health (P = .03). A trend toward a decrease in ESR was observed in DHEA group (P = .06). DAS was improved in both groups; however, there was no significant change in DAS28 between groups (P = .88). Frequency of adverse events albeit minor was similar in both groups.
CONCLUSION


Our study supports a slightly superior effect of DHEA over placebo to improve QOL in premenopausal female patients with rheumatoid arthritis. We did not find improvement in DAS in the DHEA group over placebo.",2020,In comparison to the control group more improvement in QOL (P = .025) and environment health (P = .001) was observed in the DHEA group.,"['46 premenopausal rheumatoid arthritis patients', 'premenopausal rheumatoid arthritis patients', 'premenopausal female patients with rheumatoid arthritis', 'premenopausal women with rheumatoid arthritis', 'patients with rheumatoid arthritis (RA']","['glucocorticoids', 'DHEA', 'placebo', '50\xa0mg/d DHEA', 'adrenocortical hormone, dehydroepiandrosterone (DHEA', 'dehydroepiandrosterone']","['physical health', 'DAS28', 'quality of life (QOL', 'QOL', 'ESR', 'DAS', 'Persian-validated World Health Organization Quality of Life Brief version (WHOQOL BREF) questionnaire', 'quality of life', 'environment health', 'Disease Activity Score of 28 joints - erythrocyte sedimentation rate (DAS28-ESR) questionnaire, visual analog score and swollen and tender joint counts']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count'}]",,0.375743,In comparison to the control group more improvement in QOL (P = .025) and environment health (P = .001) was observed in the DHEA group.,"[{'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Sandoughi', 'Affiliation': 'Department of Internal Medicine, Ali-Ebn e Abitaleb Hospital, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Mahmoud Ali', 'Initials': 'MA', 'LastName': 'Kaykhaei', 'Affiliation': 'Department of Internal Medicine, Ali-Ebn e Abitaleb Hospital, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Langarizadeh', 'Affiliation': 'Department of Internal Medicine, Ali-Ebn e Abitaleb Hospital, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Dashipour', 'Affiliation': 'Department of Food Sciences and Nutrition, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",International journal of rheumatic diseases,['10.1111/1756-185X.13975']
2817,32975922,Subclinical hypothyroidism in pregnancy: controversies on diagnosis and treatment.,"The negative impact of even subtle maternal thyroid hormone deficiency on pregnancy outcome and intellectual development of progeny has been known for many years but unfortunately the diagnosis and treatment of subclinical hypothyroidism in pregnant women still evokes controversies. Due to physiological changes in thyroid function and thyroid hormones metabolism occuring during pregnancy the trimester-specific reference ranges for thyroid-stimulating hormone (TSH) and free thyroid hormones should be established, but because of inter-assay differences and other confounders including ethnicity and iodine intake such norms are reliable only for local populations and unique laboratory method. In turn, the fixed reference ranges suggested by endocrine societies may carry a risk of misclassification some healthy pregnant women to be hypothyroid. The value of levothyroxine treatment on pregnancy and children cognitive outcomes is not clear. Therapeutic benefits in decreasing miscarriage and preterm delivery rates were observed when intervention was held in the first trimester in women with TSH level 2.5-10 mU/l, mainly ≥4.0 mU/l. The possible harmful effect of treatment includes preterm delivery, gestational diabetes, hypertension and pre-eclampsia. The only three prospective, randomized, placebo controlled trials evaluating efficacy of levothyroxine therapy on children intelligence quotient were started in the second trimester, may be too late to demonstrate differences between treatment and placebo groups. Awaiting for the results of future trials clinician should be aware that low-dose levothyroxine 25-50 µg daily is probably not harmful and may be beneficial but mechanistic implementation of therapy in each pregnant women with TSH >2.5mU/l seems too simplistic.",2020,"Therapeutic benefits in decreasing miscarriage and preterm delivery rates were observed when intervention was held in the first trimester in women with TSH level 2.5-10 mU/l, mainly ≥4.0 mU/l.","['Subclinical hypothyroidism in pregnancy', 'pregnant women with TSH >2.5mU', 'healthy pregnant women']","['levothyroxine', 'levothyroxine therapy', 'placebo']","['preterm delivery, gestational diabetes, hypertension and pre-eclampsia', 'children intelligence quotient', 'miscarriage and preterm delivery rates']","[{'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}]","[{'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.104699,"Therapeutic benefits in decreasing miscarriage and preterm delivery rates were observed when intervention was held in the first trimester in women with TSH level 2.5-10 mU/l, mainly ≥4.0 mU/l.","[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Gietka-Czernel', 'Affiliation': ''}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Glinicki', 'Affiliation': ''}]",Polish archives of internal medicine,['10.20452/pamw.15626']
2818,32970554,Development and Usability Testing of a Web-based COVID-19 Self-triage Platform.,"INTRODUCTION


The development and deployment of a web-based, self-triage tool for severe respiratory syndrome coronavirus 2 (COVID-19 disease) aimed at preventing surges in healthcare utilization could provide easily understandable health guidance with the goal of mitigating unnecessary emergency department (ED) and healthcare visits. We describe the iterative development and usability testing of such a tool. We hypothesized that adult users could understand and recall the recommendations provided by a COVID-19 web-based, self-triage tool.
METHODS


We convened a multidisciplinary panel of medical experts at two academic medical schools in an iterative redesign process of a previously validated web-based, epidemic screening tool for the current COVID-19 pandemic. We then conducted a cross-sectional usability study over a 24-hour period among faculty, staff, and students at the two participating universities. Participants were randomly assigned a pre-written health script to enter into the self-triage website for testing. The primary outcome was immediate recall of website recommendations. Secondary outcomes included usability measures. We stratified outcomes by demographic characteristics.
RESULTS


A final sample of 877 participants (mean age, 32 years [range, 19-84 years]; 65.3% female) was used in the analysis. We found that 79.4% of the participants accurately recalled the recommendations provided by the website. Almost all participants (96.9%) found the website easy to use and navigate.
CONCLUSION


Adult users of a COVID-19 self-triage website, recruited from an academic setting, were able to successfully recall self-care instructions from the website and found it user-friendly. This website appears to be a feasible way to provide evidence-based health guidance to adult patients during a pandemic. Website guidance could be used to reduce unnecessary ED and healthcare visits.",2020,"Adult users of a COVID-19 self-triage website, recruited from an academic setting, were able to successfully recall self-care instructions from the website and found it user-friendly.","['877 participants (mean age, 32 years [range, 19-84 years]; 65.3% female', 'faculty, staff, and students at the two participating universities', 'Adult users of a COVID-19 self-triage website, recruited from an academic setting']",['pre-written health script to enter into the self-triage website for testing'],"['website easy to use and navigate', 'usability measures', 'immediate recall of website recommendations']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0040861', 'cui_str': 'Triage'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}]",877.0,0.0903413,"Adult users of a COVID-19 self-triage website, recruited from an academic setting, were able to successfully recall self-care instructions from the website and found it user-friendly.","[{'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Schrager', 'Affiliation': 'Emory University School of Medicine, Department of Emergency Medicine, Atlanta, Georgia.'}, {'ForeName': 'Keke', 'Initials': 'K', 'LastName': 'Schuler', 'Affiliation': 'National Center for Disaster Medicine and Public Health, Department, Bethesda, Maryland.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Isakov', 'Affiliation': 'Emory University School of Medicine, Department of Emergency Medicine, Atlanta, Georgia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': 'Emory University School of Medicine, Department of Emergency Medicine, Atlanta, Georgia.'}, {'ForeName': 'Anna Q', 'Initials': 'AQ', 'LastName': 'Yaffee', 'Affiliation': 'Emory University School of Medicine, Department of Emergency Medicine, Atlanta, Georgia.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Jacobson', 'Affiliation': 'Rollins School of Public Health, Department of Health Policy and Management, Atlanta, Georgia.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Parker', 'Affiliation': 'Emory University School of Medicine, Department of Emergency Medicine, Atlanta, Georgia.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Goolsby', 'Affiliation': 'Uniformed Services University of the Health Sciences, Department of Military and Emergency Medicine, Bethesda, Maryland.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.7.48217']
2819,32970558,Barrier Enclosure for Endotracheal Intubation in a Simulated COVID-19 Scenario: A Crossover Study.,"INTRODUCTION


Barrier enclosures have been developed to reduce the risk of COVID-19 transmission to healthcare providers during intubation, but little is known about their impact on procedure performance. We sought to determine whether a barrier enclosure delays time to successful intubation by experienced airway operators.
METHODS


We conducted a crossover simulation study at a tertiary academic hospital. Participants watched a four-minute video, practiced one simulated intubation with a barrier enclosure, and then completed one intubation with and one without the barrier enclosure (randomized to determine order). The primary outcome measure was time from placement of the video laryngoscope at the lips to first delivered ventilation. Secondary outcomes were periprocedural complications and participant responses to a post-study survey.
RESULTS


Proceduralists (n = 50) from emergency medicine and anesthesiology had median intubation times of 23.6 seconds with practice barrier enclosure, 20.5 seconds with barrier enclosure, and 16.7 seconds with no barrier. Intubation with barrier enclosure averaged 4.5 seconds longer (95% confidence interval, 2.7-6.4, p < .001) than without, but was less than the predetermined clinical significance threshold of 10 seconds. Three complications occurred, all during the practice intubation. Barrier enclosure made intubation more challenging according to 48%, but 90% indicated they would consider using it in clinical practice.
CONCLUSION


Experienced airway operators performed intubation using a barrier enclosure with minimal increased time to procedure completion in this uncomplicated airway model. Given potential to reduce droplet spread, use of a barrier enclosure may be an acceptable adjunct to endotracheal intubation for those familiar with its use.",2020,Experienced airway operators performed intubation using a barrier enclosure with minimal increased time to procedure completion in this uncomplicated airway model.,[],"['minute video, practiced one simulated intubation with a barrier enclosure, and then completed one intubation with and one without the barrier enclosure']","['time from placement of the video laryngoscope at the lips to first delivered ventilation', 'periprocedural complications and participant responses to a post-study survey', 'median intubation times']",[],"[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",,0.297641,Experienced airway operators performed intubation using a barrier enclosure with minimal increased time to procedure completion in this uncomplicated airway model.,"[{'ForeName': 'Torrey A', 'Initials': 'TA', 'LastName': 'Laack', 'Affiliation': 'Mayo Clinic, Department of Emergency Medicine, Rochester, Minnesota.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pollok', 'Affiliation': 'Mayo Clinic, Mayo Clinic Multidisciplinary Simulation Center, Rochester, Minnesota.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Sandefur', 'Affiliation': 'Mayo Clinic, Department of Emergency Medicine, Rochester, Minnesota.'}, {'ForeName': 'Aidan F', 'Initials': 'AF', 'LastName': 'Mullan', 'Affiliation': 'Mayo Clinic, Division of Biomedical Statistics and Informatics, Rochester, Minnesota.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Russi', 'Affiliation': 'Mayo Clinic, Department of Emergency Medicine, Rochester, Minnesota.'}, {'ForeName': 'Suraj M', 'Initials': 'SM', 'LastName': 'Yalamuri', 'Affiliation': 'Mayo Clinic, Department of Anesthesiology, Rochester, Minnesota.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.7.48574']
2820,32970811,Implementation of French recommendations for the prevention and the treatment of hospital-acquired pneumonia: a cluster-randomized trial.,"BACKGROUND


We determined whether an audit on the adherence to guidelines for hospital-acquired pneumonia (HAP) for can improve the outcomes of patients in intensive care units (ICUs).
METHODS


This study was conducted at 35 ICUs in 30 hospitals. We included consecutive adult patients hospitalized in ICUs for three days or more. After a three-month baseline period followed by the dissemination of recommendations, an audit on the compliance to recommendations (audit period) was followed by a three-month cluster-randomized trial. We randomly assigned ICUs to either audit and feedback (intervention group) or participation to a national registry (control group). The primary outcome was the duration of ICU stay.
RESULTS


Among 1,856 patients enrolled, 602, 669, and 585 were recruited in the baseline, audit, and intervention periods, respectively. The composite measure of compliance was 47(38-56)% in the intervention group and 42(25-53)% in the control group (p=0.001). As compared to the baseline period, the ICU length of stay was reduced by 3.2 days in the intervention group (p=0.07) and by 2.8 days in the control group (p=0.02). The duration of ICU stay was 7 (5-14) in the control group and 9 (5-20) days in the intervention group (p=0.10). After adjustment for unbalanced baseline characteristics, the hazard ratio for being discharged alive from ICU in the control group was 1.17 (95% CI, 0.69 to 2.01; p=0.10).
CONCLUSIONS


The publication of French guidelines for HAP was associated with a reduction of the ICU length of stay. However, the realization of an audit to improve their application did not further improve outcomes.",2020,"As compared to the baseline period, the ICU length of stay was reduced by 3.2 days in the intervention group (p=0.07) and by 2.8 days in the control group (p=0.02).","['hospital-acquired pneumonia', 'consecutive adult patients hospitalized in ICUs for three days or more', '35 ICUs in 30 hospitals', '1,856 patients enrolled, 602, 669, and 585 were recruited in the baseline, audit, and intervention periods, respectively', 'patients in intensive care units (ICUs']",['audit and feedback (intervention group) or participation to a national registry (control group'],"['ICU length of stay', 'hazard ratio for being discharged alive from ICU', 'duration of ICU stay']","[{'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",1856.0,0.0813837,"As compared to the baseline period, the ICU length of stay was reduced by 3.2 days in the intervention group (p=0.07) and by 2.8 days in the control group (p=0.02).","[{'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roquilly', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hotel Dieu, CHU Nantes, Nantes, France.'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Chanques', 'Affiliation': 'Surgical Intensive Care Unit, Centre Hospitalier Universitaire, Montpellier, France.'}, {'ForeName': 'Sigismond', 'Initials': 'S', 'LastName': 'Lasocki', 'Affiliation': ""Département Anesthésie Réanimation, CHU d'Angers, Université d'Angers, Angers, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Foucrier', 'Affiliation': 'Anaesthesia Intensive Care Unit, Centre Hospitalier Universitaire de Beaujon (AP/HP), Beaujon, France.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Fermier', 'Affiliation': 'Intensive Care Unit, Simone Veil Hospital, Blois, France.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'De Courson', 'Affiliation': 'Department of Neuro-Critical Care, Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Carrie', 'Affiliation': 'Surgical and trauma Intensive Care, Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Danguy des Deserts', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hospital Inter-Armée Clermont Tonnerre, Brest, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Gakuba', 'Affiliation': 'Department of Anesthesiology and Critical Care, CHU Caen, Caen, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Constantin', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hôpital Gabriel Montpied, CHU Clermont Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Lagarde', 'Affiliation': 'Neuroréanimation-Anesthésie Neuroradiologie Interventionnelle, Hôpital Gabriel Montpied, CHU Clermont Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Holleville', 'Affiliation': 'Department of neuro-critical care, AP/HP, Creteil, France.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Blidi', 'Affiliation': 'Intensive Care Unit, Eaubonne Hospital, Eaubonne, France.'}, {'ForeName': 'Achille', 'Initials': 'A', 'LastName': 'Sossou', 'Affiliation': 'Department of Anesthesiology and Critical Care, Emile Roux Hospital, Le Puy en Velay, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Cailliez', 'Affiliation': 'Intensive Care Unit, Lorient Hospital, Lorient, France.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Monard', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hôpital Édouard Herriot, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Oudotte', 'Affiliation': 'Department of Neuro-Critical Care, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Calypso', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Department of Anesthesiology and Critical Care Medicine, Hôpital Nord, Marseille, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': 'Aix-Marseille University, Assistance Publique Hôpitaux de Marseille, Emergency Intensive Care Unit, Hopital la Timone, Marseille, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Isetta', 'Affiliation': 'Department of Anesthesiology and Cardiothoracic Intensive Care, Pierre Zobda-Quitman, Martinique, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Perrigault', 'Affiliation': 'Neuro-Intensive Care Unit, Centre Hospitalier Universitaire, Montpellier, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Lakhal', 'Affiliation': 'Department of Anesthesiology and Critical Care, Guillaume and Rene Laennec Hospital, CHU Nantes, Nantes, France.'}, {'ForeName': 'Armine', 'Initials': 'A', 'LastName': 'Rouhani', 'Affiliation': 'Severe Burn Intensive Care Unit, Hotel Dieu, CHU Nantes, Nantes, France.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': 'Department of Anesthesiology and Critical Care, Hotel Dieu, CHU Nantes, Nantes, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Guerci', 'Affiliation': 'Surgical Intensive Care Unit, Centre Hospitalier Universitaire, Nancy, France.'}, {'ForeName': 'Alexy', 'Initials': 'A', 'LastName': 'Tran Dinh', 'Affiliation': 'Anaesthesia Intensive Care Unit, Centre Hospitalier Universitaire de Bichat (AP/ HP), Paris, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chousterman', 'Affiliation': 'Department of Anesthesiology and Critical Care, Severe Burn Unit, Centre Hospitalier Universitaire de Lariboisiere (AP/HP), Paris, France.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Cupaciu', 'Affiliation': 'Anaesthesia Intensive Care Unit, Centre Hospitalier Universitaire de Saint Louis (AP/ HP), Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dahyot-Fizelier', 'Affiliation': 'Surgical Intensive Care Unit, Centre Hospitalier Universitaire, Poitiers, France.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Bellier', 'Affiliation': 'Neuro-Intensive Care Unit, Centre Hospitalier Universitaire, Poitiers, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Au Duong', 'Affiliation': 'Intensive Care Unit, Department of Anesthesiology and Critical Care, Rangueil Hospital, Centre Hospitalier Universitaire, Toulouse, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mansour', 'Affiliation': 'Department of Anesthesiology and Critical Care, Pontchaillou Hospital, CHU Rennes, Rennes, France.'}, {'ForeName': 'Jérome', 'Initials': 'J', 'LastName': 'Morel', 'Affiliation': 'Department of Anesthesiology and Critical Care, CHU Saint Etienne, Saint Etienne, France.'}, {'ForeName': 'Ghilain', 'Initials': 'G', 'LastName': 'Beauplet', 'Affiliation': 'Department of Anesthesiology, Intensive care and Perioperative medicine - Hautepierre Hospital, Strasbourg, France.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vibet', 'Affiliation': 'Microbiotas Hosts Antibiotics Bacterial Resistances (MiHAR), Université de Nantes, Nantes, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Feuillet', 'Affiliation': 'DRCI, Plateforme de Méthodologie et de Biostatistique, CHU Nantes, Nantes, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Sébille', 'Affiliation': 'DRCI, Plateforme de Méthodologie et de Biostatistique, CHU Nantes, Nantes, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Leone', 'Affiliation': 'Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Department of Anesthesiology and Critical Care Medicine, Hôpital Nord, Marseille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1441']
2821,32970837,Comparison of absorbable and permanent sutures for laparoscopic sacrocervicopexy: a randomized controlled trial.,"INTRODUCTION


Pelvic organ prolapse is a common cause of morbidity and decreased quality of life among women and is treatable by laparoscopic sacrocolpopexy. Recent data suggest that absorbable sutures are a feasible and appealing option for mesh attachment given a potential decreased risk of complications related to mesh erosion. The aim of the present study was to demonstrate the non-inferiority of absorbable sutures to permanent sutures for laparoscopic sacrocervicopexy.
MATERIAL AND METHODS


We performed a randomized, single blinded, non-inferiority trial comparing late-absorbable sutures (group A) to non-absorbable sutures (group B) for anterior and posterior vaginal mesh fixation during laparoscopic sacrocervicopexy at a single center in Italy. The primary outcome was prolapse correction at 12 months after surgery, defined as the absence of a pelvic organ prolapse leading edge reaching or extending below the level of the hymen and the absence of bulge symptoms. Secondary outcomes included intraoperative parameters, postoperative characteristics, and long-term morbidity. Statistical analyses were performed using STATA version 16.
RESULTS


A total of 150 patients with pelvic organ prolapse were prospectively randomized 1:1 into two groups (A or B). Baseline characteristics and intraoperative parameters including blood loss, operation time, and intraoperative complications were comparable between groups. The success rate was 100% in both groups and no differences in prolapse correction were observed. The rates of de novo urinary incontinence and persistent urinary incontinence were also similar between groups. The rate of mesh erosion at 12 months was 0% in group A and 4% in group B (p = 0.24).
CONCLUSIONS


Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success. Moreover we did not see any differences in terms of operative parameters, intraoperative and post-operative characteristics, althought the study was no powered to these outcomes.",2020,Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success.,"['150 patients with pelvic organ prolapse', 'laparoscopic sacrocervicopexy']","['absorbable sutures to permanent sutures', 'Late absorbable sutures', 'absorbable sutures', 'late-absorbable sutures (group A) to non-absorbable sutures (group B) for anterior and posterior vaginal mesh fixation during laparoscopic sacrocervicopexy', 'absorbable and permanent sutures']","['blood loss, operation time, and intraoperative complications', 'absence of a pelvic organ prolapse leading edge reaching or extending below the level of the hymen and the absence of bulge symptoms', 'intraoperative parameters, postoperative characteristics, and long-term morbidity', 'success rate', 'rates of de novo urinary incontinence and persistent urinary incontinence', 'rate of mesh erosion', 'prolapse correction']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]",150.0,0.375679,Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success.,"[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Tagliaferri', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Policlinico Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Ruggieri', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Policlinico Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Taccaliti', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Policlinico Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Gentile', 'Affiliation': 'Department of Obstetrics and Gynecology, General Regional Hospital ""F. Miulli"", Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Didonna', 'Affiliation': 'Department of Obstetrics and Gynecology, General Regional Hospital ""F. Miulli"", Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': ""D'Asta"", 'Affiliation': 'Department of Obstetrics and Gynecology, General Regional Hospital ""F. Miulli"", Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Legge', 'Affiliation': 'Department of Obstetrics and Gynecology, General Regional Hospital ""F. Miulli"", Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Guida', 'Affiliation': 'Department of Obstetrics and Gynecology, General Regional Hospital ""F. Miulli"", Acquaviva delle Fonti, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Policlinico Agostino Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Guido', 'Affiliation': 'Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Policlinico Agostino Gemelli IRCCS, Rome, Italy.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13997']
2822,32970924,Physical activity and fitness: The feasibility and preliminary effectiveness of wearable activity tracker technology incorporating altruistic motivation in youth.,"PURPOSE


The purpose of this study was to examine the feasibility and preliminary effectiveness of using wearable activity tracker technology, integrated with altruistic motivation in children to increase physical activity (PA), fitness, and prosocial behavior.
DESIGN AND METHODS


A quasiexperimental design was employed in two 4th grade classrooms in a rural southern state. The intervention was a wearable PA tracker and a web-based curriculum with activities to earn power points redeemable to provide life-saving food to undernourished kids internationally. Seventeen children in the intervention group participated in the 10-week PA program and 18 children were in the wait listed control group. Three measures were assessed in both groups at baseline and postintervention: (a) PA measured with accelerometers, (b) fitness levels measured with shuttle run, and (c) prosocial behavior measured with Strengths and Difficulties questionnaire.
RESULTS


Of the 35 children enrolled, the majority were nine years old (n = 28), black (n = 31) and female (n = 23). An overall enrollment rate of 88%, attrition rate of 9%, and an accelerometer noncompliance rate of 25% was determined to assess feasibility. There was no statistical significance between the control and intervention group outcome variables. The average minutes of PA in the control group decreased 8 min from baseline to postintervention (p = .05). In the intervention group, PA decreased by 10 min from baseline to postintervention (p = .12). In both the control and intervention groups, prosocial behavior scores decreased (p = .09 control; p = .62 intervention). The fitness scores, VO 2  max, did not significantly change (intervention p = .21; control p = .35).
PRACTICE IMPLICATIONS


Developing effective interventions that foster PA and dissuade sedentary behaviors are essential to enhancing PA and fitness levels. The recruitment, retention, and accelerometer wear adherence suggest this setting, with this population is feasible. The intervention is deliverable, however, the potential of wearable activity trackers and the effect of prosocial behavior that benefits others in increasing PA and improving cardiorespiratory fitness, should be further researched by building on the successful elements of this study.",2020,The average minutes of PA in the control group decreased 8 min from baseline to postintervention (p = .05).,"['majority were nine years old ', 'Seventeen children in the intervention group participated in the 10-week PA program and 18 children were in the wait listed control group', 'youth', 'n\u2009=\u200928), black (n\u2009=\u200931) and female (n\u2009=\u200923', '35 children enrolled', 'two 4th grade classrooms in a rural southern state']","['wearable activity tracker technology', 'wearable activity tracker technology, integrated with altruistic motivation']","['physical activity (PA), fitness, and prosocial behavior', 'fitness scores, VO 2  max', 'PA measured with accelerometers, (b) fitness levels measured with shuttle run, and (c) prosocial behavior measured with Strengths and Difficulties questionnaire', 'prosocial behavior scores', 'Physical activity and fitness', 'average minutes of PA', 'PA', 'accelerometer noncompliance rate', 'attrition rate']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",35.0,0.0224105,The average minutes of PA in the control group decreased 8 min from baseline to postintervention (p = .05).,"[{'ForeName': 'Angela A', 'Initials': 'AA', 'LastName': 'Duck', 'Affiliation': 'University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Katherine C', 'Initials': 'KC', 'LastName': 'Hall', 'Affiliation': 'University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Klamm', 'Affiliation': 'University of Mississippi Medical Center, Jackson, Mississippi, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Temple', 'Affiliation': 'Southwest Mississippi Community College, Summit, Mississippi, USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Robinson', 'Affiliation': 'University of Mississippi Medical Center, Jackson, Mississippi, USA.'}]",Journal for specialists in pediatric nursing : JSPN,['10.1111/jspn.12313']
2823,32967576,Effects of a Feedback-Demanding Stroke Clock on Acute Stroke Management: A Randomized Study.,"BACKGROUND AND PURPOSE


This randomized study aimed to evaluate whether the use of a stroke clock demanding active feedback from the stroke physician accelerates acute stroke management.
METHODS


For this randomized controlled study, a large-display alarm clock was installed in the computed tomography room, where admission, diagnostic work-up, and intravenous thrombolysis occurred. Alarms were set at the following target times after admission: (1) 15 minutes (neurological examination completed); (2) 25 minutes (computed tomography scanning and international normalized ratio determination by point-of-care laboratory completed); and (3) 30 minutes (intravenous thrombolysis started). The responsible stroke physician had to actively provide feedback by pressing a buzzer button. The alarm could be avoided by pressing the button before time out. Times to therapy decision (primary end point, defined as the end of all diagnostic work-up required for decision for or against recanalizing treatment), neurological examination, imaging, point-of-care laboratory, needle, and groin puncture were assessed by a neutral observer. Functional outcome (modified Rankin Scale) was assessed at day 90.
RESULTS


Of 107 participants, 51 stroke clock patients exhibited better stroke-management metrics than 56 control patients. Times from door to (1) end of all indicated diagnostic work-up (treatment decision time; 16.73 versus 26.00 minutes,  P <0.001), (2) end of neurological examination (7.28 versus 10.00 minutes,  P <0.001), (3) end of computed tomography (11.17 versus 14.00 minutes,  P =0.002), (4) end of computed tomography angiography (14.00 versus 17.17 minutes,  P =0.001), (5) end of point-of-care laboratory testing (12.14 versus 20.00 minutes,  P <0.001), and (6) needle times (18.83 versus 47.00 minutes,  P =0.016) were improved. In contrast, door-to-groin puncture times and functional outcomes at day 90 were not significantly different.
CONCLUSIONS


This study showed that the use of a stroke clock demanding active feedback significantly improves acute stroke-management metrics and, thus, represents a potential low-cost strategy for streamlining time-sensitive stroke treatment.",2020,"In contrast, door-to-groin puncture times and functional outcomes at day 90 were not significantly different.
","['107 participants, 51 stroke clock patients', 'Acute Stroke Management']",['Feedback-Demanding Stroke Clock'],"['Functional outcome (modified Rankin Scale', 'stroke-management metrics', 'acute stroke-management metrics', 'neurological examination', 'diagnostic work-up required for decision for or against recanalizing treatment), neurological examination, imaging, point-of-care laboratory, needle, and groin puncture']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}]",107.0,0.0644424,"In contrast, door-to-groin puncture times and functional outcomes at day 90 were not significantly different.
","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Fousse', 'Affiliation': 'Department of Neurology, Saarland University Medical Center, Homburg, Germany. (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grün', 'Affiliation': 'Department of Neurology, Saarland University Medical Center, Homburg, Germany. (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.).'}, {'ForeName': 'Stefan A', 'Initials': 'SA', 'LastName': 'Helwig', 'Affiliation': 'Department of Neurology, Saarland University Medical Center, Homburg, Germany. (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.).'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Walter', 'Affiliation': 'Department of Neurology, Saarland University Medical Center, Homburg, Germany. (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.).'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bekhit', 'Affiliation': 'Institute of Medical Biometry, Epidemiology, and Medical Informatics, Saarland University Medical Center, Homburg, Germany. (A.B., S. Wagenpfeil).'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wagenpfeil', 'Affiliation': 'Institute of Medical Biometry, Epidemiology, and Medical Informatics, Saarland University Medical Center, Homburg, Germany. (A.B., S. Wagenpfeil).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lesmeister', 'Affiliation': 'Department of Neurology, Saarland University Medical Center, Homburg, Germany. (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kettner', 'Affiliation': 'Department of Neuroradiology, Saarland University Medical Center, Homburg, Germany. (M.K., S.R., R.M.-B., A.S., U.Y., W.R.).'}, {'ForeName': 'Safwan', 'Initials': 'S', 'LastName': 'Roumia', 'Affiliation': 'Department of Neuroradiology, Saarland University Medical Center, Homburg, Germany. (M.K., S.R., R.M.-B., A.S., U.Y., W.R.).'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Mühl-Benninghaus', 'Affiliation': 'Department of Neuroradiology, Saarland University Medical Center, Homburg, Germany. (M.K., S.R., R.M.-B., A.S., U.Y., W.R.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Simgen', 'Affiliation': 'Department of Neuroradiology, Saarland University Medical Center, Homburg, Germany. (M.K., S.R., R.M.-B., A.S., U.Y., W.R.).'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Neuroradiology, Saarland University Medical Center, Homburg, Germany. (M.K., S.R., R.M.-B., A.S., U.Y., W.R.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ruckes', 'Affiliation': 'Interdisciplinary Center of Clinical Studies, Johannes Gutenberg University, Mainz, Germany (C.R., K.K.).'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Kronfeld', 'Affiliation': 'Interdisciplinary Center of Clinical Studies, Johannes Gutenberg University, Mainz, Germany (C.R., K.K.).'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Bachhuber', 'Affiliation': 'Department of Neurology, Saarland University Medical Center, Homburg, Germany. (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.).'}, {'ForeName': 'Iris Q', 'Initials': 'IQ', 'LastName': 'Grunwald', 'Affiliation': 'Department of Neuroscience, Medical School, Anglia Ruskin University, Chelmsford, United Kingdom and Division of Imaging Science and Technology, School of Medicine, University of Dundee, United Kingdom (I.Q.G.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bertsch', 'Affiliation': 'Institute of Clinical Chemistry, Laboratory Medicine and Transfusion Medicine, Paracelsus Medical University, Nuremberg, Germany (T.B.).'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Reith', 'Affiliation': 'Department of Neuroradiology, Saarland University Medical Center, Homburg, Germany. (M.K., S.R., R.M.-B., A.S., U.Y., W.R.).'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Fassbender', 'Affiliation': 'Department of Neurology, Saarland University Medical Center, Homburg, Germany. (M.F., D.G., S.A.H., S. Walter, M.L., M.B., K.F.).'}]",Stroke,['10.1161/STROKEAHA.120.029222']
2824,32967704,Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial.,"BACKGROUND


Chronic widespread pain (CWP), including fibromyalgia (FM), affects one in every ten adults and is one of the leading causes of sick leave and emotional distress. Due to an unclear etiology and a complex pathophysiology, FM is a condition with few, if any, effective and safe treatments. However, current research within the field of vagal nerve innervation suggests psychophysiological and electrical means by which FM may be treated. This study will investigate the efficacy of two different noninvasive vagal nerve stimulation techniques for the treatment of FM.
METHODS


The study will use a randomized, single-blind, sham-controlled design to investigate the treatment efficacy of motivational nondirective resonance breathing (MNRB™) and transcutaneous vagus nerve stimulation (Nemos® tVNS) on patients diagnosed with FM. Consenting FM patients (N = 112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway, will be randomized into one of four independent groups. Half of these participants (N = 56) will be randomized to either an experimental tVNS group or a sham tVNS group. The other half (N = 56) will be randomized to either an experimental MNRB group or a sham MNRB group. Both active and sham treatment interventions will be delivered twice per day at home, 15 min/morning and 15 min/evening, for a total duration of 2 weeks (14 days). Participants are invited to the clinic twice, once for pre- and once for post-intervention data collection. The primary outcome is changes in photoplethysmography-measured heart rate variability. Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pressure pain limit determined by computerized pressure cuff algometry, blood pressure, and health-related quality of life.
DISCUSSION


The described randomized controlled trial aims to compare the efficacy of two vagal nerve innervation interventions, MNRB and tVNS, on heart rate variability and pain intensity in patients suffering from FM. This project tests a new and potentially effective means of treating a major public and global health concern where prevalence is high, disability is severe, and treatment options are limited.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03180554 . Registered on August 06, 2017.",2020,"Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pressure pain limit determined by computerized pressure cuff algometry, blood pressure, and health-related quality of life.
","['patients diagnosed with FM', 'fibromyalgia', 'patients suffering from FM', 'Consenting FM patients (N\u2009=\u2009112) who are referred to the Department of Pain Management and Research at Oslo University Hospital, in Oslo, Norway']","['Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation', 'vagal nerve innervation interventions, MNRB and tVNS', 'experimental tVNS group or a sham tVNS', 'noninvasive vagal nerve stimulation techniques', 'motivational nondirective resonance breathing (MNRB™) and transcutaneous vagus nerve stimulation (Nemos® tVNS', 'experimental MNRB group or a sham MNRB']","['self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pressure pain limit determined by computerized pressure cuff algometry, blood pressure, and health-related quality of life', 'changes in photoplethysmography-measured heart rate variability', 'heart rate variability and pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0231881', 'cui_str': 'Resonance'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0021516', 'cui_str': 'Innervation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.203999,"Secondary outcomes include self-reported pain intensity on a numeric rating scale, changes in pain detection threshold, pain tolerance threshold, and pressure pain limit determined by computerized pressure cuff algometry, blood pressure, and health-related quality of life.
","[{'ForeName': 'Charles Ethan', 'Initials': 'CE', 'LastName': 'Paccione', 'Affiliation': 'Doctoral Fellow in Medicine and Health Sciences, Faculty of Medicine, University of Oslo, Klaus Torgårds 3, 0372, Oslo, Norway. Charles.Ethan.Paccione@columbia.edu.'}, {'ForeName': 'Lien My', 'Initials': 'LM', 'LastName': 'Diep', 'Affiliation': 'Oslo Center for Biostatistics and Epidemiology, Sognsvannsveien 9, 0372, Oslo, Norway.'}, {'ForeName': 'Audun', 'Initials': 'A', 'LastName': 'Stubhaug', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Ullevål, Kirkeveien 166, 0853, Oslo, Norway.'}, {'ForeName': 'Henrik Børsting', 'Initials': 'HB', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Pain Management and Research, Oslo University Hospital, Ullevål, Kirkeveien 166, 0853, Oslo, Norway.'}]",Trials,['10.1186/s13063-020-04703-6']
2825,32967713,Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS).,"BACKGROUND


The self-management of osteoarthritis (OA) and low back pain (LBP) through activity and skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial.
METHODS


This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland, between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants' cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters.
RESULTS


Fourteen clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (intervention: mean (SD) = 4.92 (1.31), range 2-7; UP: mean (SD) = 5.08 (2.43), range 1-9). One hundred twenty participants (83.3% of n = 144 expected) were recruited (intervention n = 59; UP n = 61), with follow-up data obtained from 80.8% (n = 97) at 6 weeks, 84.2% (n = 101) at 2 months and 71.7% (n = 86) at 6 months. Most participants received treatment as allocated (intervention n = 49; UP n = 54). The qualitative interviews (12 participants; 10 physiotherapists (PTs) found the intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between-group effects.
CONCLUSIONS


While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial.
TRIAL REGISTRATION


ISRCTN ISRCTN49875385 . Registered on 26 March 2014.",2020,"The qualitative interviews (12 participants; 10 physiotherapists (PTs) found the intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required.","['Fourteen clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (intervention: mean (SD)\u2009=\u20094.92 (1.31), range 2-7; UP: mean (SD)\u2009=\u20095.08 (2.43), range 1-9', 'One hundred twenty participants (83.3% of n\u2009=\u2009144 expected) were recruited (intervention n\u2009=\u200959; UP n\u2009=\u200961', 'and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland, between September 2014 and November 2015', 'osteoarthritis and low back pain (SOLAS', 'Patients with OA of the hip, knee, lumbar spine']","['SOLAS intervention to usual individual physiotherapy', 'theory-driven group-based complex intervention versus usual physiotherapy']",[],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]",[],14.0,0.167081,"The qualitative interviews (12 participants; 10 physiotherapists (PTs) found the intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required.","[{'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Hurley', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Room A302, Health Sciences Centre, Belfield, Dublin 4, Ireland. deirdre.hurleyosing@ucd.ie.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Jeffares', 'Affiliation': ""Division of Population Health Sciences, Royal College of Surgeons in Ireland, St Stephen's Green, Dublin 2, Ireland.""}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Hall', 'Affiliation': 'Faculty of Medicine, Memorial University, St Johns, Newfoundland, Canada.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Keogh', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Room A302, Health Sciences Centre, Belfield, Dublin 4, Ireland.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Toomey', 'Affiliation': 'Health Behaviour Change Research Group, School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McArdle', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Room A302, Health Sciences Centre, Belfield, Dublin 4, Ireland.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'McDonough', 'Affiliation': ""School of Physiotherapy, Royal College of Surgeons in Ireland, St Stephen's Green, Dublin 2, Ireland.""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Guerin', 'Affiliation': 'School of Psychology, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Segurado', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Room A302, Health Sciences Centre, Belfield, Dublin 4, Ireland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Matthews', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Room A302, Health Sciences Centre, Belfield, Dublin 4, Ireland.'}]",Trials,['10.1186/s13063-020-04671-x']
2826,32967726,Electrolytes supplementation can decrease the risk of nephrotoxicity in patients with solid tumors undergoing chemotherapy with cisplatin.,"BACKGROUND


Cisplatin is an important drug in the treatment of various Cancers. However, this drug causes nephrotoxicity that is linked to electrolyte derangement. The aim of this study was to evaluate the effect of electrolyte supplementation in reducing kidney injury in patients receiving cisplatin-based regimen.
METHODS


This was non-randomized interventional study conducted at Ocean Road Cancer Institute (ORCI) among patients with confirmed solid tumors. Patients who received cisplatin-based chemotherapy at a dose of ≥50 mg with intravenous normal saline supplemented with Magnesium, Calcium and Potassium (triple electrolyte supplementation) were compared with those who received cisplatin-based chemotherapy with normal saline alone. The patients were followed up for 4 weeks and serum creatinine was measured at every visit. Nephrotoxicity was defined as serum creatinine elevation > 1.5 times that at baseline.
RESULTS


A total of 99 patients were recruited, whereby 49 patients (49.5%) received electrolyte supplementation (treatment group) and 50 patients (51.5%) did not receive electrolyte supplementation (control group). The incidence risk of nephrotoxicity was 20.41% (n = 10) in the treatment group and 54% (n = 27) in the control group. Patients in the control group were 2.6 times more likely to experience nephrotoxicity as compared to treatment group [Relative Risks (RR); 2.6, 95%CI; 1.5-4.9, P < 0.0001]. The most common malignancy was cervical cancer, n = 43 (87.8%) in treatment group and n = 45 (90.0%) in the control group (P = 0.590). The Kaplan-Meier analysis and the log-rank test revealed that electrolytes supplementation was associated with extended survival with less nephrotoxicity incidences [P = 0.0004; Hazard ratio (HR) 0.3149; 95% CI 0.165 to 0.6011].
CONCLUSIONS


Electrolytes supplementation decreases the risk of nephrotoxicity after chemotherapy with cisplatin. A randomized controlled trial with a larger sample size is recommended to evaluate the robustness of these findings.",2020,The incidence risk of nephrotoxicity was 20.41% (n = 10) in the treatment group and 54% (n = 27) in the control group.,"['patients with solid tumors undergoing chemotherapy with', 'A total of 99 patients were recruited, whereby 49 patients (49.5%) received', 'patients with confirmed solid tumors', 'patients receiving cisplatin-based regimen']","['electrolyte supplementation', 'cisplatin-based chemotherapy', 'cisplatin', 'Electrolytes supplementation', 'intravenous normal saline supplemented with Magnesium, Calcium and Potassium (triple electrolyte supplementation', 'Cisplatin', 'cisplatin-based chemotherapy with normal saline alone', 'electrolyte supplementation (control group']","['experience nephrotoxicity', 'serum creatinine', 'incidence risk of nephrotoxicity', 'serum creatinine elevation', 'risk of nephrotoxicity', 'Nephrotoxicity', 'extended survival with less nephrotoxicity incidences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",99.0,0.200158,The incidence risk of nephrotoxicity was 20.41% (n = 10) in the treatment group and 54% (n = 27) in the control group.,"[{'ForeName': 'Omary M S', 'Initials': 'OMS', 'LastName': 'Minzi', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania. minziobejayesu@gmail.com.'}, {'ForeName': 'Tatu E', 'Initials': 'TE', 'LastName': 'Lyimo', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.'}, {'ForeName': 'Francis F', 'Initials': 'FF', 'LastName': 'Furia', 'Affiliation': 'Department of Paediatrics and Child Health, School of Medicine, Muhimbili University of Health and Allied Sciences, P. O. Box 65001, Dar es Salaam, Tanzania.'}, {'ForeName': 'Alphonce I', 'Initials': 'AI', 'LastName': 'Marealle', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.'}, {'ForeName': 'Manase', 'Initials': 'M', 'LastName': 'Kilonzi', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.'}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Bwire', 'Affiliation': 'Department of Pharmaceutical Microbiology, School of Pharmacy, Muhimbili University of Health and Allied Sciences, P. O. Box 65013, Dar es Salaam, Tanzania.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Malichewe', 'Affiliation': 'Department of Radiology, MUHAS, P.O. Box 65000, Dar es Salaam, Tanzania.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-00448-9']
2827,32967742,"Casein glycomacropeptide is well tolerated in healthy adults and changes neither high-sensitive C-reactive protein, gut microbiota nor faecal butyrate: a restricted randomised trial.","Casein glycomacropeptide (CGMP) is a bioactive milk-derived peptide with potential anti-inflammatory effects. Animal studies suggest that CGMP may work by altering gut microbiota composition and enhancing butyrate production. Its effects on intestinal homeostasis, microbiota and metabolites in humans are unknown. The aim of the present study was to assess both the intestinal and systemic immunomodulatory effects of orally ingested CGMP. We hypothesised that a daily oral CGMP intake would reduce high-sensitive C-reactive protein in healthy adults. In a single-centre limited but randomised, double-blinded, reference-controlled study, we compared the effects of a four-week intervention of either 25 grams of oral powder-based chocolate-flavoured CGMP or a reference drink. We included twenty-four healthy adults who all completed the study. CGMP had no systemic or intestinal immunomodulatory effects compared with a reference drink, either with regard to high-sensitive C-reactive protein, or faecal calprotectin level, faecal microbiota composition or faecal short-chain fatty acid content. CGMP ingestion did not affect satiety or body weight, and it caused no severe adverse events. The palatability of CGMP was acceptable and adherence was high. CGMP did not induce or change gastrointestinal symptoms. In conclusion, we found no immunomodulatory effects of CGMP in healthy adults. In a minor group of healthy adults, oral ingestion of 25 grams of CGMP during four weeks was safe, well tolerated, had acceptable palatability, and was without any effects on body weight.",2020,"CGMP had no systemic or intestinal immunomodulatory effects compared with a reference drink, either with regard to high-sensitive C-reactive protein, or faecal calprotectin level, faecal microbiota composition or faecal short-chain fatty acid content.","['twenty-four healthy adults who all completed the study', 'healthy adults']","['Casein glycomacropeptide (CGMP', 'orally ingested CGMP', 'oral powder-based chocolate-flavoured CGMP or a reference drink', 'CGMP', 'Casein glycomacropeptide']","['safe, well tolerated, had acceptable palatability', 'systemic or intestinal immunomodulatory effects', 'faecal calprotectin level, faecal microbiota composition or faecal short-chain fatty acid content', 'intestinal homeostasis, microbiota and metabolites', 'gut microbiota composition and enhancing butyrate production', 'satiety or body weight', 'body weight', 'change gastrointestinal symptoms', 'palatability of CGMP']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0286762', 'cui_str': 'caseinomacropeptide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1160731', 'cui_str': 'Oral powder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0286762', 'cui_str': 'caseinomacropeptide'}]",24.0,0.195539,"CGMP had no systemic or intestinal immunomodulatory effects compared with a reference drink, either with regard to high-sensitive C-reactive protein, or faecal calprotectin level, faecal microbiota composition or faecal short-chain fatty acid content.","[{'ForeName': 'Pernille G', 'Initials': 'PG', 'LastName': 'Wernlund', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Hvas', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Dahlerup', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Martin I', 'Initials': 'MI', 'LastName': 'Bahl', 'Affiliation': 'National Food Institute, Technical University of Denmark, Denmark.'}, {'ForeName': 'Tine R', 'Initials': 'TR', 'LastName': 'Licht', 'Affiliation': 'National Food Institute, Technical University of Denmark, Denmark.'}, {'ForeName': 'Knud E', 'Initials': 'KE', 'LastName': 'B Knudsen', 'Affiliation': 'Department of Animal Science, Aarhus University, Tjele, Denmark.'}, {'ForeName': 'Jørgen S', 'Initials': 'JS', 'LastName': 'Agnholt', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}]",The British journal of nutrition,['10.1017/S0007114520003736']
2828,32967873,Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts (EuRIDICE): study protocol for a prospective randomised multi-centre double-blind placebo-controlled clinical trial in the Netherlands.,"INTRODUCTION


Delirium in critically ill adults is associated with prolonged hospital stay, increased mortality and greater cognitive and functional decline. Current practice guideline recommendations advocate the use of non-pharmacological strategies to reduce delirium. The routine use of scheduled haloperidol to treat delirium is not recommended given a lack of evidence regarding its ability to resolve delirium nor improve relevant short-term and longer-term outcomes. This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.
METHODS AND ANALYSIS


EuRIDICE is a prospective, multi-centre, randomised, double-blind, placebo-controlled trial. Study population consists of adult intensive care unit (ICU) patients without acute neurological injury who have delirium based on a positive Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the ICU (CAM-ICU) assessment. Intervention is intravenous haloperidol 2.5 mg (or matching placebo) every 8 hours, titrated daily based on ICDSC or CAM-ICU positivity to a maximum of 5 mg every 8 hours, until delirium resolution or ICU discharge. Main study endpoint is delirium and coma-free days (DCFD) up to 14 days after randomisation. Secondary endpoints include (1) 28-day and 1-year mortality, (2) cognitive and functional performance at 3 and 12 months, (3) patient and family delirium and ICU experience, (4) psychological sequelae during and after ICU stay, (4) safety concerns associated with haloperidol use and (5) cost-effectiveness. Differences in DCFDs between haloperidol and placebo group will be analysed using Poisson regression analysis. Study recruitment started in February 2018 and continues.
ETHICS AND DISSEMINATION


The study has been approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam (MEC2017-511) and by the Institutional Review Boards of the participating sites. Its results will be disseminated via peer-reviewed publication and conference presentations.
TRIAL REGISTRATION


NCT03628391.",2020,"This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.
","['adult Critically ill patiEnts (EuRIDICE', 'adult critically ill patients to reduce days spent with coma or delirium', 'Study population consists of adult intensive care unit (ICU) patients without acute neurological injury who have delirium based on a positive Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the ICU (CAM-ICU) assessment']","['halopeRIdol', 'haloperidol 2.5\u2009mg (or matching placebo', 'placebo', 'haloperidol']","['burden of Delirium', 'DCFDs', 'efficacy and safety', 'delirium and coma-free days (DCFD', '1) 28-day and 1-year mortality, (2) cognitive and functional performance at 3 and 12 months, (3) patient and family delirium and ICU experience, (4) psychological sequelae during and after ICU stay, (4) safety concerns associated with haloperidol use and (5) cost-effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0751792', 'cui_str': 'Injury of nervous system'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.593027,"This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium.
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Smit', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Trogrlić', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'Department of Pharmacy and Health Systems Sciences, Northeastern University Bouve College of Health Sciences, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'Osse', 'Affiliation': 'Department of Psychiatry, Erasmus MC - University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Huibert H', 'Initials': 'HH', 'LastName': 'Ponssen', 'Affiliation': 'Department of Intensive Care, Albert Schweitzer Hospital Location Dordwijk, Dordrecht, Zuid-Holland, Netherlands.'}, {'ForeName': 'Arjen J C', 'Initials': 'AJC', 'LastName': 'Slooter', 'Affiliation': 'Department of Intensive Care Medicine and UMC Utrecht Brain Center, University Medical Centre Utrecht Brain Centre, Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Nicole G M', 'Initials': 'NGM', 'LastName': 'Hunfeld', 'Affiliation': 'Department of Pharmacy and Department of Intensive Care Adults, Erasmus MC - University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Wim J R', 'Initials': 'WJR', 'LastName': 'Rietdijk', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Diederik', 'Initials': 'D', 'LastName': 'Gommers', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'van der Jagt', 'Affiliation': 'Department of Intensive Care Adults, Erasmus MC- University Medical Center, Rotterdam, Zuid-Holland, Netherlands m.vanderjagt@erasmusmc.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036735']
2829,32967874,"Integrated communication support program for oncologists, caregivers and patients with rapidly progressing advanced cancer to promote patient-centered communication: J-SUPPORT 1904 study protocol for a randomised controlled trial.","INTRODUCTION


Communication is an essential aspect of care for patients with progressive serious illnesses. This study aims to evaluate the efficacy of a new, integrated communication support program for oncologists, patients with rapidly progressing advanced cancer and their caregivers.
METHODS AND ANALYSIS


The proposed integrated communication support programme is in the randomised control trial stage. It comprises a cluster of oncologists from comprehensive cancer centre hospitals in a metropolitan area in Japan. A total of 20 oncologists, 200 patients with advanced pancreatic cancer and the patients' caregivers are enrolled in this study as of the writing of this protocol report. Oncologists are randomly assigned to the intervention group (IG) or control group (CG). Patients and caregivers are allocated to the same group as their oncologists. The IG oncologists receive a 2.5-hour individual communication skills training, and patients and caregivers receive a half-hour coaching intervention to facilitate prioritising and discussing questions and concerns; the CG participants do not receive any training. Follow-up data will be collected quarterly for 6 months for a year and then annually for up to 3 years. The primary endpoint is the intergroup difference between before-intervention and after-intervention patient-centred communication behaviours during oncology visits.
ETHICS AND DISSEMINATION


This study is conducted in accordance with the ethical guidelines for clinical studies published by Japan's Ministry of Education, Cultural, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of National Cancer Center, Japan on 4 July 2018 (ID: 2017-474).
TRIAL STATUS


This study is currently enrolling participants. Enrolment period ends 31 July 2020; estimated follow-up date is 31 March 2023.
TRIAL REGISTRATION NUMBER


UMIN Clinical Trial Registry (UMIN000033612); pre-results.",2020,"The primary endpoint is the intergroup difference between before-intervention and after-intervention patient-centred communication behaviours during oncology visits.
","['patients with rapidly progressing advanced cancer and their caregivers', 'oncologists, caregivers and patients with rapidly progressing advanced cancer to promote patient-centered communication', ""200 patients with advanced pancreatic cancer and the patients' caregivers"", 'comprehensive cancer centre hospitals in a metropolitan area in Japan', 'patients with progressive serious illnesses']","['2.5-hour individual communication skills training, and patients and caregivers receive a half-hour coaching intervention to facilitate prioritising and discussing questions and concerns; the CG participants do not receive any training', 'integrated communication support program', 'Integrated communication support program', 'intervention group (IG) or control group (CG']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],200.0,0.0842864,"The primary endpoint is the intergroup difference between before-intervention and after-intervention patient-centred communication behaviours during oncology visits.
","[{'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Fujimori', 'Affiliation': 'Division of Behavioral Science and Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan mfujimor@ncc.go.jp.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Sato', 'Affiliation': 'Division of Behavioral Science and Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Jinno', 'Affiliation': 'Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Chuo-ku, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine Department of Medical Biochemistry, Sendai, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary Pancreatic Oncology, National Cancer Center-Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Ozaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Medical Oncology, Public Interest Incorporated Foundation Cancer Institute Hospital of JFCR, Koto-ku, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Takayama', 'Affiliation': ""Department of Medicine, Institute of Gastroenterology, Tokyo Women's Medical University Hospital, Shinjuku-ku, Japan.""}, {'ForeName': 'Tempei', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Department of Clinical Trial Data Management, Tokyo University Graduate School of Medicine, Bunkyo-ku, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Majima', 'Affiliation': 'President, Pancreatic Cancer Action Network, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Division of Behavioral Science and Division of Health Care Research, Center for Public Health Sciences, National Cancer Center, Chuo-ku, Japan.'}]",BMJ open,['10.1136/bmjopen-2019-036745']
2830,32967877,Efficacy and safety of intravenous immunoglobulin with rituximab versus rituximab alone in childhood-onset steroid-dependent and frequently relapsing nephrotic syndrome: protocol for a multicentre randomised controlled trial.,"INTRODUCTION


Guidelines for the treatment of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS) are lacking. Given the substantial impact of SDNS/FRNS on quality of life, strategies aiming to provide long-term remission while minimising treatment side effects are needed. Several studies confirm that rituximab is effective in preventing early relapses in SDNS/FRNS; however, the long-term relapse rate remains high (~70% at 2 years). This trial will assess the association of intravenous immunoglobulins (IVIgs) to rituximab in patients with SDNS/FRNS and inform clinicians on whether IVIg's immunomodulatory properties can alter the course of the disease and reduce the use of immunosuppressive drugs and their side effects.
METHODS AND ANALYSIS


We conduct an open-label multicentre, randomised, parallel group in a 1:1 ratio, controlled, superiority trial to assess the safety and efficacy of a single infusion of rituximab followed by IVIg compared with rituximab alone in childhood-onset FRNS/SDNS. The primary outcome is the occurrence of first relapse within 24 months. Patients are allocated to receive either rituximab alone (375 mg/m²) or rituximab followed by IVIg, which includes an initial Ig dose of 2 g/kg, followed by 1.5 g/kg injections once a month for the following 5 months (maximum dose: 100 g).
ETHICS AND DISSEMINATION


The study has been approved by the ethics committee (Comité de Protection des Personnes) of Ouest I and authorised by the French drug regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé). Results of the primary study and the secondary aims will be disseminated through peer-reviewed publications.
TRIAL REGISTRATION NUMBER


NCT03560011.",2020,"INTRODUCTION


Guidelines for the treatment of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS) are lacking.","['patients with SDNS/FRNS', 'childhood-onset FRNS/SDNS', 'childhood-onset steroid-dependent and frequently relapsing nephrotic syndrome']","['SDNS/FRNS', 'intravenous immunoglobulin with rituximab versus rituximab alone', 'rituximab', 'intravenous immunoglobulins (IVIgs) to rituximab', 'rituximab alone']","['Efficacy and safety', 'safety and efficacy', 'occurrence of first relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.194947,"INTRODUCTION


Guidelines for the treatment of steroid-dependent nephrotic syndrome (SDNS) and frequently relapsing nephrotic syndrome (FRNS) are lacking.","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France julien.hogan@aphp.fr.'}, {'ForeName': 'Aubriana', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Department of Surgery, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Sellier-Leclerc', 'Affiliation': 'Department of Pediatric Nephrology, Hôpital Femme Mère Enfant, Bron, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vrillon', 'Affiliation': 'Department of Pediatric Nephrology, Hopital Brabois enfants, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Francoise', 'Initials': 'F', 'LastName': 'Broux', 'Affiliation': 'Department of Pediatric Nephrology, University Hospital Centre Rouen, Rouen, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Nobili', 'Affiliation': 'Department of Pediatric Nephrology, University Hospital Centre Besancon, Besancon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Harambat', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Bordeaux Groupe hospitalier Pellegrin, Bordeaux, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Bessenay', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Audard', 'Affiliation': 'Department of Nephrology and Transplantation, Henri Mondor Hospital, APHP, Université Paris-Est, Créteil, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Faudeux', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Nice, Nice, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Morin', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Montpellier, Montpellier, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Pietrement', 'Affiliation': ""Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Reims Hôpital d'enfants, Reims, France.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tellier', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Djamal', 'Initials': 'D', 'LastName': 'Djeddi', 'Affiliation': 'Department of Paediatrics, Amiens University Hospital and University of Amiens, Amiens, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Eckart', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lahoche', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Régional Universitaire de Lille, Lille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Roussey-Kesler', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ulinski', 'Affiliation': 'Department of Pediatric Nephrology, Hopital Trousseau la Roche-Guyon, Paris, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Boyer', 'Affiliation': 'Department of Pediatric Nephrology, Hopital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Plaisier', 'Affiliation': 'Department of Nephrology, Hopital Tenon, Paris, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Cloarec', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Régional Universitaire de Tours, Tours, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Jolivot', 'Affiliation': 'Department of Nephrology, Groupement Hospitalier Edouard Herriot, Lyon, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Guigonis', 'Affiliation': 'Department of Pediatric Nephrology, Centre Hospitalier Universitaire de Limoges, Limoges, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Guilmin-Crepon', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Baudouin', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dossier', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Deschênes', 'Affiliation': 'Department of Pediatric Nephrology, Robert Debré Hospital, APHP, Paris, France.'}]",BMJ open,['10.1136/bmjopen-2020-037306']
2831,32967883,Phase II study of concomitant radiotherapy with atezolizumab in oligometastatic soft tissue sarcomas: STEREOSARC trial protocol.,"INTRODUCTION


Up to 50% of soft tissue sarcoma (STS) patients develop metastases in the course of their disease. Cytotoxic therapy is a standard treatment in this setting but yields average tumour response rates of 25% at first line and ≤10% at later lines. In oligometastatic stage, stereotactic body radiation therapy (SBRT) allows reaching high control rates at treated sites (≥80%) and is potentially equally effective to surgery in term of overall survival. In order to shift the balance towards antitumour immunity by multisite irradiation, radiation could be combined with inhibitors of the immunosuppressive pathways.
METHODS AND ANALYSIS


STEREOSARC is a prospective, multicentric, randomised phase II, designed to evaluate the efficacy of SBRT associated with immunotherapy versus SBRT only. Randomisation is performed with a 2:1 ratio within two arms. The primary objective is to evaluate the efficacy, in term of progression-free survival (PFS) rate at 6 months, of immunomodulated stereotactic multisite irradiation in oligometastatic sarcoma patients. The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution. Patients will be randomised in two groups: SBRT with atezolizumab and SBRT alone. The total number of included patients should be 103.
TRIAL REGISTRATION


The trial is registered on ClinicalTrials.gov (ID: NCT03548428).
ETHICS AND DISSEMINATION


This study has been approved by Comité de Protection des Personnes du sud-ouest et outre-mer 4 on 18 October 2019 (Reference CPP2019-09-076-PP) and from National Agency for Medical and Health products Safety (Reference: MEDAECNAT-2019-08-00004_2017-004239-35) on 18 September 2019.The results will be disseminated to patients upon individual request or through media release from scientific meetings. The results will be communicated through scientific meetings and publications.",2020,"The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution.","['et outre-mer 4 on 18 October 2019', 'oligometastatic sarcoma patients', 'oligometastatic soft tissue sarcomas']","['SBRT with atezolizumab and SBRT alone', 'immunomodulated stereotactic multisite irradiation', 'Cytotoxic therapy', 'SBRT', 'concomitant radiotherapy with atezolizumab', 'stereotactic body radiation therapy (SBRT']","['PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution', 'progression-free survival (PFS) rate']","[{'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0876936', 'cui_str': 'Mathematical Model'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}]",,0.112088,"The secondary objectives include PFS by immune response criteria, overall survival, quality-of-life evaluation and developing mathematical models of tumour growth and dissemination predictive of oligometastatic versus polymetastatic evolution.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'le Guevelou', 'Affiliation': 'Radiation oncology department, Centre de Lutte Contre le Cancer, Centre Francois Baclesse, Caen, France.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Debaigt', 'Affiliation': 'clinical research department, UNICANCER, Paris, Île-de-France, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada-Bouzid', 'Affiliation': ""Medical oncology department, Centre Antoine Lacassagne, Nice, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Viotti', 'Affiliation': ""Medical oncology department, Centre Antoine Lacassagne, Nice, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Nazim', 'Initials': 'N', 'LastName': 'Khalladi', 'Affiliation': 'Biomolecular pathology department, Centre de Lutte Contre le Cancer, Centre François Baclesse, Caen, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thibouw', 'Affiliation': 'Medical oncology department, Georges-Francois Leclerc Centre, Dijon, Bourgogne-Franche-Comté, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': 'Medical oncology department, Centre Oscar Lambret, lille, France.'}, {'ForeName': 'Marie Pierre', 'Initials': 'MP', 'LastName': 'Sunyach', 'Affiliation': 'Centre Léon Bérard, Lyon, Rhône-Alpes, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Moureau-Zabotto', 'Affiliation': ""Paoli-Calmettes Institute, Marseille, Provence-Alpes-Côte d'Azur, France.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Benchalal', 'Affiliation': 'Eugène Marquis Cancer Institute, Rennes, Bretagne, France.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Veresezan', 'Affiliation': 'Radiation oncology department, CHU Rouen Biochimie Médicale, Rouen, Haute-Normandie, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ducassou', 'Affiliation': 'Radiation oncology department, IUCT Oncopole, Toulouse, Languedoc-Roussillon-Midi, France.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'le Pechoux', 'Affiliation': 'Radiation oncology department, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jolnerovski', 'Affiliation': 'clinical research department, UNICANCER, Paris, Île-de-France, France.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Bazille', 'Affiliation': 'Biomolecular pathology department, CHU Caen, Caen, Basse-Normandie, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Vaur', 'Affiliation': 'Biomolecular pathology department, Centre de Lutte Contre le Cancer, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Escande', 'Affiliation': 'Radiation oncology department, Oscar Lambret Cancer Centre, Lille, Hauts-de-France, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Serre', 'Affiliation': 'Radiation oncology department, CHU Limoges, Limoges, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lovera', 'Affiliation': 'clinical research department, UNICANCER, Paris, Île-de-France, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Radiation oncology department, Centre de Lutte Contre le Cancer, Centre Francois Baclesse, Caen, France jthariat@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-038391']
2832,32968391,Comparative response of Desmopressin versus Combination Therapy (Desmopressin + Oxybutynin) in Children with Nocturnal Enuresis.,"Objective


To assess the safety as well as efficacy of desmopressin monotherapy alone and in combination (desmopressin + oxybutynin) in treating nocturnal urinary incontinence among children with 7 to 13 years.
Methods


This randomized controlled trial has been carried out in National Institute of Child Health from September 2018 to March 2019 with the utilization of convenient sampling technique. Data has been collected after taking ethical approval and informed consent of the Parents with complete confidentiality. The sample size was 84 and equal number of patients was divided in two groups. Group-I was given desmopressin at monotherapy at a dose of 0.2 mg and Group-II was given desmopressin and oxybutynin at the dose of 0.2 mg desmopressin and 5 mg oxybutynin patients were diagnosed on the basis of history. Routine lab investigation included Urine DR and ultrasound abdomen.
Results


In this study significant differences between two groups were found with respect to socio economic status, lack of education of parents (P Less than 0.05). The frequency, urgency and incontinence of this ailment was significantly controlled by combination therapy (desmopressin + oxybutynin) as compared to desmopressin as monotherapy (P Less than 0.05) as patient was followed after one, two and three monthly basis.
Conclusion


Desmopressin combination with oxybutynin is more effective as compared to monotherapy treatment. The affectivity of the combination therapy was very high with least side effects and all the children recovered from the condition at third month of treatment. Furthermore, headache was observed to be common with monotherapy and loss of appetite was observed with combination therapy.",2020,The affectivity of the combination therapy was very high with least side effects and all the children recovered from the condition at third month of treatment.,"['Children with Nocturnal Enuresis', 'children with 7 to 13 years', 'National Institute of Child Health from September 2018 to March 2019 with the utilization of convenient sampling technique']","['desmopressin', 'desmopressin monotherapy alone and in combination (desmopressin + oxybutynin', 'combination therapy (desmopressin + oxybutynin', 'desmopressin at monotherapy', 'desmopressin and oxybutynin at the dose of 0.2 mg desmopressin', 'Desmopressin versus Combination Therapy (Desmopressin + Oxybutynin']","['headache', 'Urine DR and ultrasound abdomen', 'nocturnal urinary incontinence', 'appetite', 'frequency, urgency and incontinence of this ailment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270327', 'cui_str': 'Nocturnal enuresis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0069805', 'cui_str': 'oxybutynin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",,0.0194892,The affectivity of the combination therapy was very high with least side effects and all the children recovered from the condition at third month of treatment.,"[{'ForeName': 'Asiya', 'Initials': 'A', 'LastName': 'Kazi', 'Affiliation': 'Dr. Asiya Kazi, MBBS, Pharmacology Department, Bahria University Medical & Dental College, Sailors Street, Adjacent PNS Shifa, Defence Phase 2, Karachi, Pakistan.'}, {'ForeName': 'Kemchand N', 'Initials': 'KN', 'LastName': 'Moorani', 'Affiliation': 'Prof. Dr. Khemchand N. Moorani, MBBS, MCPS, FCPS. Department of Paediatric Nephrology, National Institute of Child Health and Human Development (NICHD), Karachi, Pakistan.'}, {'ForeName': 'Shabih', 'Initials': 'S', 'LastName': 'Zehra', 'Affiliation': 'Dr. Shabih Zehra, MBBS, MCPS, FCPS. Department of Radiology, PNS Shifa Hospital DHA, Karachi, Pakistan.'}, {'ForeName': 'Ijaz Hussain', 'Initials': 'IH', 'LastName': 'Zaidi', 'Affiliation': 'Prof. Dr. Ijaz Hussain Zaidi Faisal, MBBS, PhD. Pharmacology Department, Bahria University Medical & Dental College, Sailors Street, Adjacent PNS Shifa, Defence Phase 2, Karachi, Pakistan.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.6.1957']
2833,32968393,A randomized control study on anesthetic effects of flurbiprofen axetil combined with propofol on patients with liver cancer receiving microwave ablation.,"Objective


To evaluate the anesthetic effects of flurbiprofen axetil combined with propofol on patients with liver cancer receiving microwave ablation.
Methods


Sixty patients (SA grade: I-II) who underwent microwave ablation for liver cancer in our hospital from May 2018 to May 2019 were selected and randomly divided into a study group and a control group (n=30) that were anesthetized through target-controlled infusion of propofol combined with intravenous infusion of flurbiprofen axetil and target-controlled infusion of propofol alone, respectively. The mean arterial pressure (MAP), heart rate (HR), blood oxygen saturation (SpO 2 ), numerical rating scale (NRS) score, adverse reactions and anesthetic effects (induction time, recovery time) of the two groups were compared before anesthesia (T0), at the beginning of puncture (T1), at the beginning of microwave ablation (T2), at the end of microwave ablation (T3) and one hour after surgery (T4).
Results


MAP and HR of the study group were higher than those of the control group (P<0.05) at T2. There was no difference in SpO 2  between the two groups (P>0.05). The anesthesia induction time and recovery time of the study group were significantly shorter than those of the control group (P<0.05). There was no difference in the NRS score between the two groups at T1 (P>0.05), but the study group had lower scores at T2-T4 (P<0.05). The incidence rate of postoperative adverse reactions was 13.33% in the study group and 46.67% in the control group, with a significant difference (P<0.05).
Conclusion


Flurbiprofen axetil in combination with propofol exert evident anesthetic effects on patients with liver cancer receiving microwave ablation. The time of preoperative anesthesia induction and postoperative recovery time can be markedly shortened, and intraoperative vital signs can be maintained stable. This method is thus worthy of clinical promotion.",2020,"There was no difference in the NRS score between the two groups at T1 (P>0.05), but the study group had lower scores at T2-T4 (P<0.05).","['Sixty patients (SA grade: I-II) who underwent microwave ablation for liver cancer in our hospital from May 2018 to May 2019', 'patients with liver cancer receiving microwave ablation']","['propofol combined with intravenous infusion of flurbiprofen axetil and target-controlled infusion of propofol', 'propofol', 'Flurbiprofen axetil', 'flurbiprofen axetil combined with propofol']","['time of preoperative anesthesia induction and postoperative recovery time', 'anesthesia induction time and recovery time', 'incidence rate of postoperative adverse reactions', 'mean arterial pressure (MAP), heart rate (HR), blood oxygen saturation (SpO 2 ), numerical rating scale (NRS) score, adverse reactions and anesthetic effects (induction time, recovery time', 'anesthetic effects', 'NRS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2223560', 'cui_str': 'Time of induction of anesthesia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3179301', 'cui_str': 'Anesthetic Effects'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.0230436,"There was no difference in the NRS score between the two groups at T1 (P>0.05), but the study group had lower scores at T2-T4 (P<0.05).","[{'ForeName': 'Xingshi', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Xingshi Gu, Department of Interventional Radiology, Second Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, P. R. China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Yuan', 'Affiliation': 'Qiang Yuan, Department of Interventional Radiology, Second Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, P. R. China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Jian Zhang, Department of Interventional Radiology, Second Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, P. R. China.'}, {'ForeName': 'Yawen', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Yawen Yang, Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou 215000, Jiangsu Province, P. R. China.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.6.2091']
2834,32968400,"Study on the changes in TSH, TPO-Ab and other indicators due to Vitamin D deficiency in Pregnant Women with subclinical hypothyroidism in the first trimester.","Objective


To investigate the effect of vitamin D deficiency on the levels of thyroid stimulating hormone (TSH), thyroid peroxidase antibody (TPO-Ab), interleukin-1 (IL-1) and high-sensitivity C-reactive protein (hs-CRP) in pregnant women with early pregnancy complicated by subclinical hypothyroidism.
Methods


A total of 172 pregnant women with subclinical hypothyroidism in the first trimester diagnosed and treated in a given hospital from August 2014 to May 2018 were selected, and their levels of vitamin D were determined. Depending on the abnormality of their vitamin D levels, the study participants were divided into two groups: the study group (vitamin D≤20 ng/L) and the control group (vitamin D>20 ng/L). The levels of TSH, TPO-Ab, IL-1 and hsCRP in the two groups were measured.
Results


The levels of TSH, hsCRP and TPO-Ab in the study group were significantly higher than those in the control group (P<0.05). The comparison between the two groups in terms of IL-1 showed no statistically significant difference.
Conclusion


Vitamin D deficiency in the first trimester is associated with in an increased level of TSH in the first trimester, thereby aggravating subclinical hypothyroidism. The mechanism may be associated with the impact of vitamin D deficiency on hs-CRP and other body inflammation indicators, as well as on thyroid autoantibodies and other immune indicators, but has no effect on IL-1 levels.",2020,"The levels of TSH, hsCRP and TPO-Ab in the study group were significantly higher than those in the control group (P<0.05).","['172 pregnant women with subclinical hypothyroidism in the first trimester diagnosed and treated in a given hospital from August 2014 to May 2018 were selected, and their levels of vitamin D were determined', 'Pregnant Women with subclinical hypothyroidism in the first trimester', 'pregnant women with early pregnancy complicated by subclinical hypothyroidism']","['control group (vitamin D>20 ng/L', 'vitamin D deficiency']","['thyroid stimulating hormone (TSH), thyroid peroxidase antibody (TPO-Ab), interleukin-1 (IL-1) and high-sensitivity C-reactive protein (hs-CRP', 'IL-1 levels', 'level of TSH', 'levels of TSH, TPO-Ab, IL-1 and hsCRP', 'levels of TSH, hsCRP and TPO-Ab']","[{'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0076635', 'cui_str': 'Thyroid microsomal antibody'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",172.0,0.0654685,"The levels of TSH, hsCRP and TPO-Ab in the study group were significantly higher than those in the control group (P<0.05).","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Xue Zhou, Department of Endocrinology, Baoding first Central Hospital, Baoding, Hebei 071000, P.R.China.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Ben Li, Dept. of Thoracic Surgery, Affiliated Hospital of Hebei University, Baoding, Hebei 071000, P.R.China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Chao Wang, Department of Endocrinology, Baoding first Central Hospital, Baoding, Hebei 071000, P.R.China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Zhihong Li, Department of Endocrinology, Baoding first Central Hospital, Baoding, Hebei 071000, P.R.China.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.6.1982']
2835,32968404,Clinical study of different doses of atorvastatin combined with febuxostat in patients with gout and carotid atherosclerosis.,"Objective


To evaluate the efficacy of atorvastatin combined with febuxostat in the treatment of gout patients with carotid atherosclerosis and to observe the effects on serum tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and C-reactive protein (CRP) levels, carotid plaques, and the adverse reactions.
Methods


Seventy patients with gout and carotid atherosclerosis admitted to Affiliated Hospital of Hebei University from January 2014 to June 2017 were randomly divided into a treatment group and a control group. The treatment group received oral febuxostat 40 mg/day combined with atorvastatin 40 mg/day. The control group was given 40 mg/day febuxostat combined with 20 mg/day atorvastatin for 90 days. The effects of treatment on TNF-α, IL-1β, and CRP levels and carotid plaques of the patients were observed.
Results


After 90 days of treatment, serum TNF-α, IL-1β, and CRP levels, as well as HUA and total cholesterol (TC), decreased in both groups after treatment. There were significant differences observed (p < 0.05). The carotid artery plaques in the two groups were significantly smaller after treatment (P<0.05). There was no significant difference in adverse reactions between the two groups (P > 0.05).
Conclusion


Double doses of atorvastatin combined with febuxostat can effectively reduce uric acid to improve the inflammatory state in patients and reduce carotid plaques without increasing the incidence of adverse reactions.",2020,The carotid artery plaques in the two groups were significantly smaller after treatment (P<0.05).,"['patients with gout and carotid atherosclerosis', 'gout patients with carotid atherosclerosis', 'Seventy patients with gout and carotid atherosclerosis admitted to Affiliated Hospital of Hebei University from January 2014 to June 2017']","['atorvastatin combined with febuxostat', 'oral febuxostat 40 mg/day combined with atorvastatin', 'febuxostat combined with 20 mg/day atorvastatin']","['TNF-α, IL-1β, and CRP levels and carotid plaques', 'adverse reactions', 'carotid artery plaques', 'serum TNF-α, IL-1β, and CRP levels, as well as HUA and total cholesterol (TC', 'serum tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and C-reactive protein (CRP) levels, carotid plaques, and the adverse reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2608989', 'cui_str': 'febuxostat 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0751633', 'cui_str': 'Carotid Artery Plaque'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",70.0,0.0255321,The carotid artery plaques in the two groups were significantly smaller after treatment (P<0.05).,"[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Zheng Zhang, Department of Rheumatology and Immunology, Affiliated Hospital of Hebei University, Baoding, Hebei 071000, P. R. China.'}, {'ForeName': 'Ming-Hua', 'Initials': 'MH', 'LastName': 'Xu', 'Affiliation': 'Ming-hua Xu, Department of Rheumatology and Immunology, Affiliated Hospital of Hebei University, Baoding, Hebei 071000, P. R. China.'}, {'ForeName': 'Feng-Ju', 'Initials': 'FJ', 'LastName': 'Wei', 'Affiliation': 'Feng-ju Wei, Department of Traditional Chinese Medicine Department, Affiliated Hospital of Hebei University, Baoding, Hebei 071000, P. R. China.'}, {'ForeName': 'Li-Na', 'Initials': 'LN', 'LastName': 'Shang', 'Affiliation': 'Li-na Shang, Department of Ultrasound, Affiliated Hospital of Hebei University, Baoding, Hebei 071000, P. R. China.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.6.2945']
2836,32971179,"High-intensity interval training on body composition, functional capacity and biochemical markers in healthy young versus older people.","BACKGROUND


The aim of the following study was to identify the effects of a 12-week high-intensity interval training (HIIT) program on the modification of parameters of body composition, aerobic capacity, functional capacity as well as lipid and glucose homeostasis markers in healthy young people vs older adults.
DESIGN


Experimental trial.
METHODS


Healthy young (YNG, 21 ± 1 years, BMI 26.01 ± 2.64, n = 10) and older (OLD, 66 ± 5 years, BMI 27.43 ± 3.11, n = 10) males were subjected to 12 weeks of HIIT. Prior to and immediately after the HIIT program, dual-energy X-ray absorptiometry, one-repetition maximum (1-RM) dominant leg strength, maximal oxygen uptake (VO 2max ) and functional capacity tests were performed. Blood samples were also taken.
RESULTS


Flexibility (P = 0.000), static balance (P = 0.004), timed up and go test (TUG) (P = 0.015), physical performance (P = 0.005), 1-RM dominant leg strength (P = 0.012), and VO 2max  (P = 0.000) were better in YNG versus OLD. HIIT improved the 1-RM dominant leg strength (P = 0.025), VO 2max  (P = 0.000), % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006). TUG was improved by the training only in the OLD group (P = 0.016), but insulin (P = 0.002) and the homeostasis model assessment - insulin sensitivity (HOMA-IS) (P = 0.000) decreased only in the YNG group. HOMA-IS was correlated moderately and positive with BMI (R = 0.474, P = 0.035) and whole-body fat mass (R = 0.517, P = 0.019).
CONCLUSIONS


HIIT for 12 weeks improves parameters of body composition, functional capacity and fasting serum lipid and glucose homeostasis markers in healthy young and older participants.",2020,"HIIT improved the 1-RM dominant leg strength (P = 0.025), VO 2max  (P = 0.000), % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006).","['Healthy young (YNG, 21\u202f±\u202f1\u202fyears, BMI 26.01\u202f±\u202f2.64, n\u202f=\u202f10) and older (OLD, 66\u202f±\u202f5\u202fyears, BMI 27.43\u202f±\u202f3.11, n\u202f=\u202f10) males', 'healthy young and older participants', 'healthy young versus older people', 'healthy young people vs older adults']","['high-intensity interval training (HIIT) program', 'High-intensity interval training']","['homeostasis model assessment - insulin sensitivity (HOMA-IS', 'HOMA-IS', 'repetition maximum (1-RM) dominant leg strength, maximal oxygen uptake (VO 2max ) and functional capacity tests', 'TUG', 'static balance', 'body composition, functional capacity and biochemical markers', 'body composition, functional capacity and fasting serum lipid and glucose homeostasis markers', 'Flexibility', 'leg lean mass', 'body composition, aerobic capacity, functional capacity as well as lipid and glucose homeostasis markers', 'timed up and go test (TUG', '1-RM dominant leg strength', 'physical performance', 'VO 2max', 'fasting cholesterol', 'fasting glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",,0.0125358,"HIIT improved the 1-RM dominant leg strength (P = 0.025), VO 2max  (P = 0.000), % whole-body fat mass (P = 0.031), leg lean mass (P = 0.047), fasting cholesterol (P = 0.017) and fasting glucose (P = 0.006).","[{'ForeName': 'Gabriel Nasri', 'Initials': 'GN', 'LastName': 'Marzuca-Nassr', 'Affiliation': 'Departamento de Medicina Interna, Facultad of Medicine, Universidad de La Frontera, Temuco, Chile; Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile. Electronic address: gabriel.marzuca@ufrontera.cl.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Artigas-Arias', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile; Departamento de Procesos Terapéuticos, Facultad de Ciencias de la Salud, Universidad Católica de Temuco, Temuco, Chile.'}, {'ForeName': 'María Angélica', 'Initials': 'MA', 'LastName': 'Olea', 'Affiliation': 'Departamento de Educación Física, Deporte y Recreación, Facultad de Educación, Ciencias Sociales y Humanidades, Universidad de la Frontera, Temuco, Chile.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'SanMartín-Calísto', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Nolberto', 'Initials': 'N', 'LastName': 'Huard', 'Affiliation': 'Centro de Biología Molecular y Farmacogenética, Departamento de Ciencias Básicas, Facultad of Medicine, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Durán-Vejar', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Beltrán-Fuentes', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Muñoz-Fernández', 'Affiliation': 'Carrera de Kinesiología, Facultad de Medicina, Universidad de La Frontera, Chile.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Alegría-Molina', 'Affiliation': 'Magíster en Terapia Física con menciones, Facultad de Medicina, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Sapunar', 'Affiliation': 'Departamento de Medicina Interna, Facultad of Medicine, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Salazar', 'Affiliation': 'Centro de Biología Molecular y Farmacogenética, Departamento de Ciencias Básicas, Facultad of Medicine, Universidad de La Frontera, Temuco, Chile.'}]",Experimental gerontology,['10.1016/j.exger.2020.111096']
2837,32971190,Relative and Absolute Risk Reductions in Cardiovascular and Kidney Outcomes With Canagliflozin Across KDIGO Risk Categories: Findings From the CANVAS Program.,"RATIONALE & OBJECTIVE


Canagliflozin reduces the risk of cardiovascular and kidney outcomes in type 2 diabetes. This study aimed to assess the relative and absolute effects of canagliflozin on clinical outcomes across different Kidney Disease: Improving Global Outcomes (KDIGO) risk categories based on estimated glomerular filtration rate (eGFR) and urinary albumin:creatinine ratio (UACR.
STUDY DESIGN


Post-hoc analysis of the Canagliflozin Cardiovascular Assessment Study (CANVAS) Program.
SETTINGS


& Participants: The CANVAS Program randomized 10,142 participants with type 2 diabetes at high cardiovascular risk and an eGFR of ≥30 mL/min/1.73 m 2  to canagliflozin or placebo.
INTERVENTION(S)


Canagliflozin or matching placebo.
OUTCOMES


The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death, with a set of other cardiovascular and kidney pre-specified outcomes.
RESULTS


Of 10,142 participants, 10,031 (98.9%) had available baseline eGFR and UACR data. The proportions of participants in low-, moderate-, high-, and very high-risk categories were 58.6%, 25.8%, 10.6%, and 5.0%, respectively. The relative effect of canagliflozin on the primary outcome (HR 0.86, 95% CI 0.75-0.97) was consistent across KDIGO risk categories (P-trend=0.21), with similar results for other cardiovascular and kidney outcomes. Absolute reductions in the primary outcome were greater within higher KDIGO risk categories (P-trend=0.03) with a similar pattern of effect for the composite of cardiovascular death or hospitalization for heart failure (P-trend=0.06) and for chronic eGFR slope (P-trend=0.04).
LIMITATIONS


Predominantly a low kidney risk population, relatively few participants in higher KDIGO risk categories, and exclusion of individuals with eGFR <30 mL/min/1.73 m 2 .
CONCLUSIONS


While the relative effects of canagliflozin are similar across KDIGO risk categories, absolute risk reductions are likely greater for individuals at higher KDIGO risk. The KDIGO classification system may be able to identify individuals who might derive greater benefits for end-organ protection from treatment with canagliflozin.",2020,"Absolute reductions in the primary outcome were greater within higher KDIGO risk categories (P-trend=0.03) with a similar pattern of effect for the composite of cardiovascular death or hospitalization for heart failure (P-trend=0.06) and for chronic eGFR slope (P-trend=0.04).
","['type 2 diabetes', 'Of 10,142 participants, 10,031 (98.9%) had available baseline eGFR and UACR data', ' Participants', '10,142 participants with type 2 diabetes at high cardiovascular risk and an eGFR of ≥30 mL/min/1.73 m 2  to']","['canagliflozin', 'canagliflozin or placebo', 'Canagliflozin', 'Canagliflozin or matching placebo']","['glomerular filtration rate (eGFR) and urinary albumin:creatinine ratio', 'cardiovascular death or hospitalization for heart failure', 'risk of cardiovascular and kidney outcomes', 'higher KDIGO risk categories', 'chronic eGFR slope', 'composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death, with a set of other cardiovascular and kidney pre-specified outcomes']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",10142.0,0.354133,"Absolute reductions in the primary outcome were greater within higher KDIGO risk categories (P-trend=0.03) with a similar pattern of effect for the composite of cardiovascular death or hospitalization for heart failure (P-trend=0.06) and for chronic eGFR slope (P-trend=0.04).
","[{'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'de Zeeuw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Fulcher', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Blais', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li MBiostat', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Concord Repatriation General Hospital, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Centre for Nephrology, University College London, London, UK. Electronic address: d.wheeler@ucl.ac.uk.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.06.018']
2838,32971253,Effects of 13-valent Pneumococcal Conjugate Vaccination of adults on lower respiratory tract infections and antibiotic use in primary care: secondary analysis of a double-blind randomized placebo-controlled study.,"OBJECTIVES


The efficacy of 13-valent pneumococcal conjugate vaccine (PCV13) in adults to prevent community-acquired pneumonia (CAP) and lower respiratory tract infections (LRTI) not requiring hospitalization is unknown. We determined the effect of PCV13 on CAP, LRTI, and antibiotic use in the primary care setting.
METHODS


Community-dwelling immunocompetent adults over 65 years of age were randomized to PCV13 or placebo as part of the double-blind Community-Acquired Pneumonia immunization Trial in Adults (CAPiTA). CAP and LRTI episodes and antibiotic prescription data were extracted from general practitioner information systems of 40,426 subjects. Vaccine efficacy (VE) of PCV13 was determined using Poisson regression with robust standard errors, comparing CAP and non-CAP LRTI episodes, LRTI-specific, and total antibiotic prescriptions.
RESULTS


20,195 participants received PCV13 and 20,231 placebo. A total of 1,564 and 1,659 CAP episodes occurred in the PCV13 and placebo group, respectively; VE (95% CI): 5.5% (-2.6% - 13.0%). Non-CAP LRTI episodes occurred 7,535 and 7,817 times in the PCV13 and placebo group, respectively; VE (95% CI): 3.4% (-2.0% - 8.5%). A total of 8,835 and 9,245 LRTI-related antibiotic courses were prescribed in the PCV13 and placebo arm, respectively; VE (95% CI): 4.2% (-1.0% - 9.1%). Antibiotic courses for any indication were prescribed 43,386 and 43,309 times, respectively; VE (95% CI): -0.4% (-4.9% - 3.9%).
CONCLUSIONS


PCV13 vaccination in the elderly is unlikely to cause a relevant reduction in the incidence of CAP, LRTI, LRTI-related antibiotic use or total antibiotic use in primary care.",2020,"CAP LRTI episodes occurred 7,535 and 7,817 times in the PCV13 and placebo group, respectively; VE (95% CI): 3.4% (-2.0% - 8.5%).","['Community-dwelling immunocompetent adults over 65\xa0years of age', 'adults on lower respiratory tract infections and antibiotic use in primary care', 'adults to prevent community-acquired pneumonia (CAP) and lower respiratory tract infections (LRTI', '40,426 subjects']","['PCV13 or placebo', '13-valent pneumococcal conjugate vaccine (PCV13', '13-valent Pneumococcal Conjugate Vaccination', 'PCV13 and 20,231 placebo', 'PCV13', 'placebo', 'PCV13 vaccination']","['CAP, LRTI, and antibiotic use', 'CAP LRTI episodes', 'Vaccine efficacy (VE) of PCV13']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C3661918', 'cui_str': 'Pneumococcal conjugate vaccination'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.572271,"CAP LRTI episodes occurred 7,535 and 7,817 times in the PCV13 and placebo group, respectively; VE (95% CI): 3.4% (-2.0% - 8.5%).","[{'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'van Werkhoven', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands. Electronic address: c.h.vanwerkhoven@umcutrecht.nl.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Bolkenbaas', 'Affiliation': 'Affiliation of the work performed: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Huijts', 'Affiliation': 'Affiliation of the work performed: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Theo J M', 'Initials': 'TJM', 'LastName': 'Verheij', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Marc J M', 'Initials': 'MJM', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Medical Microbiology, University Medical Center Utrecht, Utrecht University, the Netherlands.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.09.011']
2839,32971262,Another's pain in my brain: No evidence that placebo analgesia affects the sensory-discriminative component in empathy for pain.,"The shared representations account of empathy suggests that sharing other people's emotions relies on neural processes similar to those engaged when directly experiencing such emotions. Recent research corroborated this by showing that placebo analgesia induced for first-hand pain resulted in reduced pain empathy and decreased activation in shared neural networks. However, those studies did not report any placebo-related variation of somatosensory engagement during pain empathy. The experimental paradigms used in these studies did not direct attention towards a specific body part in pain, which may explain the absence of effects for somatosensation. The main objective of this preregistered study was to implement a paradigm overcoming this limitation, and to investigate whether placebo analgesia may also modulate the sensory-discriminative component of empathy for pain. We induced a localized, first-hand placebo analgesia effect in the right hand of 45 participants by means of a placebo gel and conditioning techniques, and compared this to the left hand as a control condition. Participants underwent a pain task in the MRI scanner, receiving painful or non-painful electrical stimulation on their left or right hand, or witnessing another person receiving such stimulation. In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses. We thus report no evidence for somatosensory sharing in empathy, while replicating previous studies showing overlapping brain activity in the affective-motivational component for first-hand and empathy for pain. Hence, in a more rigorous test aiming to overcome limitations of previous work, we again find no causal evidence for the engagement of somatosensory sharing in empathy. Our study refines the understanding of the neural underpinnings of empathy for pain, and the use of placebo analgesia in investigating such models.",2020,"In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses.","[""Another's pain in my brain"", '45 participants by means of a']","['placebo', 'pain task in the MRI scanner, receiving painful or non-painful electrical stimulation on their left or right hand, or witnessing another person receiving such stimulation', 'placebo gel and conditioning techniques']","['behavioral nor neural responses', 'pain empathy']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",45.0,0.195586,"In contrast to a robust localized placebo analgesia effect for self-experienced pain, the empathy condition showed no differences between the two hands, neither for behavioral nor neural responses.","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hartmann', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Riva', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria. Electronic address: claus.lamm@univie.ac.at.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117397']
2840,32971593,Blossom smart expander technology for tissue expander-based breast reconstruction facilitates shorter duration to full expansion: A pilot study.,"BACKGROUND


This study evaluated the Blossom system, an innovative self-filling, rate-controlled, pressure-responsive saline tissue expander (TE) system. We investigated the feasibility of utilizing this technology to facilitate implant-based and combined flap with implant-based breast reconstruction in comparison to conventional tissue expansion.
METHODS


In this prospective, single-center, single-surgeon pilot study, participants underwent either implant-based breast reconstruction or a combination of autologous flap and implantbased breast reconstruction. Outcome measures included time to full expansion, complications, total expansion volume, and pain scores.
RESULTS


Fourteen patients (TEs; n=22), were included in this study. The mean time to full expansion was 13.4 days (standard error of the mean [SEM], 1.3 days) in the combination group and 11.7 days (SEM, 1.4 days) in the implant group (P=0.78). The overall major complication rate was 4.5% (n=1). No statistically significant differences were found in the complication rate between the combination group and the implant group. The maximum patient-reported pain scores during the expansion process were low, but were significantly higher in the combination group (mean, 2.00±0.09) than in the implant group (mean, 0.29±0.25; P=0.005).
CONCLUSIONS


The reported average duration for conventional subcutaneous TE expansion is 79.4 days, but this pilot study using the Blossom system achieved an average expansion duration of less than 14 days in both groups. The Blossom system may accommodate single-stage breast reconstruction. The overall complication rate of this study was 4.5%, which is promising compared to the reported complication rates of two-stage breast reconstruction with TEs (20%-45%).",2020,No statistically significant differences were found in the complication rate between the combination group and the implant group.,['Fourteen patients (TEs; n=22'],"['combined flap with implant-based breast reconstruction', 'implant-based breast reconstruction or a combination of autologous flap and implantbased breast reconstruction']","['mean time to full expansion', 'overall complication rate', 'complication rate', 'time to full expansion, complications, total expansion volume, and pain scores', 'complication rates', 'overall major complication rate', 'pain scores']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0401048,No statistically significant differences were found in the complication rate between the combination group and the implant group.,"[{'ForeName': 'Youna K', 'Initials': 'YK', 'LastName': 'Choi', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, Palo Alto, CA, USA.'}, {'ForeName': 'Danielle H', 'Initials': 'DH', 'LastName': 'Rochlin', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, Palo Alto, CA, USA.'}, {'ForeName': 'Dung H', 'Initials': 'DH', 'LastName': 'Nguyen', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Stanford University Medical Center, Palo Alto, CA, USA.'}]",Archives of plastic surgery,['10.5999/aps.2020.00535']
2841,32971764,"Effects of Chewing Exerciser on the Recovery of Masticatory Function Recovery after Orthognathic Surgery: A Single-Center Randomized Clinical Trial, a Preliminary Study.","Background and Objectives : The aim of this study was to evaluate the effects of the chewing exerciser (CE) on the functional recovery of the masticatory muscles after orthognathic surgery.  Material and Methods:  This randomized clinical trial was conducted in patients undergoing bimaxillary orthognathic surgery including bilateral sagittal split ramus osteotomy. Postoperative physiotherapy (PT) was performed for 3 weeks starting 3 weeks after the surgery. The patients were randomly divided into two groups: control (Con) (conventional PT) group and CE group (use of CE in addition to conventional PT). The masticatory function was evaluated based on three standards: bite force (BF), amount of mouth opening (MO), and surface electromyography (sEMG) of the anterior temporal muscle (TA), masseter muscle (MM), sternocleidomastoid muscle, and anterior belly of digastric muscle before, 3 weeks (before PT) and 6 weeks after the surgery (after PT).  Results:  Finally, 22 subjects participated in this study: 10 patients for Con group and 12 patients for CE group. In both groups, the BF, which was reduced significantly after the surgery, recovered after the PT similar to that before the surgery. In both groups, the MO was also significantly reduced by the surgery. However, it did not recover as much, as it was before the surgery after applying the PT. There was no difference in BF and MO between the two groups. All muscles did not show significant changes in sEMG by surgery and PT at both resting and clenching states.  Conclusion:  Applying CE as a PT after orthognathic surgery did not cause any harmful side effects. In both groups, the weakened muscle activity after orthognathic surgery (OGS) was adequately restored 6 weeks after the surgery. However, CE did not offer a statistically significant benefit to the masticatory function in the recovery process after OGS.",2020,"However, CE did not offer a statistically significant benefit to the masticatory function in the recovery process after OGS.","['patients undergoing', '22 subjects participated in this study: 10 patients for Con group and 12 patients for CE group', 'after Orthognathic Surgery']","['chewing exerciser (CE', 'control (Con) (conventional PT) group and CE group (use of CE in addition to conventional PT', 'Postoperative physiotherapy (PT', 'bimaxillary orthognathic surgery including bilateral sagittal split ramus osteotomy', 'CE', 'Chewing Exerciser']","['bite force (BF), amount of mouth opening (MO), and surface electromyography (sEMG) of the anterior temporal muscle (TA), masseter muscle (MM), sternocleidomastoid muscle, and anterior belly of digastric muscle', 'sEMG', 'masticatory function', 'weakened muscle activity', 'BF and MO', 'Masticatory Function Recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]","[{'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3178772', 'cui_str': 'Sagittal Split Ramus Osteotomy'}]","[{'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039487', 'cui_str': 'Structure of temporalis muscle'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0224156', 'cui_str': 'Structure of anterior belly of digastric muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}]",22.0,0.0340369,"However, CE did not offer a statistically significant benefit to the masticatory function in the recovery process after OGS.","[{'ForeName': 'Hoon Joo', 'Initials': 'HJ', 'LastName': 'Yang', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}, {'ForeName': 'Ik Jae', 'Initials': 'IJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}, {'ForeName': 'Akram Abdo', 'Initials': 'AA', 'LastName': 'Almansoori', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}, {'ForeName': 'Yoojung', 'Initials': 'Y', 'LastName': 'Son', 'Affiliation': 'Clinical Translational Research Center for Dental Science, Seoul National University Dental Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Bongju', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Clinical Translational Research Center for Dental Science, Seoul National University Dental Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Soung-Min', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}, {'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56090483']
2842,32971774,Pre-Sleep Low Glycemic Index Modified Starch Does Not Improve Next-Morning Fuel Selection or Running Performance in Male and Female Endurance Athletes.,"To determine the effects of pre-sleep supplementation with a novel low glycemic index (LGI) carbohydrate (CHO) on next-morning substrate utilization, gastrointestinal distress (GID), and endurance running performance (5-km time-trial, TT). Using a double-blind, randomized, placebo (PLA) controlled, crossover design, trained participants ( n  = 14; 28 ± 9 years, 8/6 male/female, 55 ± 7 mL/kg/min) consumed a LGI, high glycemic index (HGI), or 0 kcal PLA supplement ≥ 2 h after their last meal and <30 min prior to sleep. Upon arrival, resting energy expenditure (REE), substrate utilization, blood glucose, satiety, and GID were assessed. An incremental exercise test (IET) was performed at 55, 65, and 75% peak volume of oxygen consumption (VO 2peak ) with GID, rating of perceived exertion (RPE) and substrate utilization recorded each stage. Finally, participants completed the 5-km TT. There were no differences in any baseline measure. During IET, CHO utilization tended to be greater with LGI (PLA, 56 ± 11; HGI, 60 ± 14; LGI, 63 ± 14%,  p  = 0.16,  η 2  = 0.14). GID was unaffected by supplementation at any point ( p  > 0.05). Performance was also unaffected by supplement (PLA, 21.6 ± 9.5; HGI, 23.0 ± 7.8; LGI, 24.1 ± 4.5 min,  p  = 0.94,  η 2  = 0.01). Pre-sleep CHO supplementation did not affect next-morning resting metabolism, BG, GID, or 5-km TT performance. The trend towards higher CHO utilization during IET after pre-sleep LGI, suggests that such supplementation increases morning CHO availability.",2020,"Pre-sleep CHO supplementation did not affect next-morning resting metabolism, BG, GID, or 5-km TT performance.","['trained participants ( n  = 14; 28 ± 9 years, 8/6 male/female, 55 ± 7 mL/kg/min) consumed a', 'Male and Female Endurance Athletes']","['pre-sleep supplementation with a novel low glycemic index (LGI) carbohydrate (CHO', 'Pre-Sleep Low Glycemic Index Modified Starch', 'placebo', 'LGI, high glycemic index (HGI), or 0 kcal PLA supplement ≥ 2 h after their last meal and <30 min prior to sleep', 'Pre-sleep CHO supplementation']","['Performance', 'next-morning substrate utilization, gastrointestinal distress (GID), and endurance running performance (5-km time-trial, TT', 'oxygen consumption (VO 2peak ) with GID, rating of perceived exertion (RPE) and substrate utilization recorded each stage', 'CHO utilization', 'GID', 'next-morning resting metabolism, BG, GID, or 5-km TT performance', 'morning CHO availability', 'Upon arrival, resting energy expenditure (REE), substrate utilization, blood glucose, satiety, and GID']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0548823', 'cui_str': 'Distress gastrointestinal'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",,0.412373,"Pre-sleep CHO supplementation did not affect next-morning resting metabolism, BG, GID, or 5-km TT performance.","[{'ForeName': 'Monique D', 'Initials': 'MD', 'LastName': 'Dudar', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Emilie D', 'Initials': 'ED', 'LastName': 'Bode', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Karly R', 'Initials': 'KR', 'LastName': 'Fishkin', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Rochelle A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Madeleine M', 'Initials': 'MM', 'LastName': 'Carre', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Noa R', 'Initials': 'NR', 'LastName': 'Mills', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ormsbee', 'Affiliation': 'Department of Nutrition, Food, and Exercise Sciences, Institute of Sport Sciences and Medicine, Florida State University, Tallahassee, FL 32306, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Ives', 'Affiliation': 'Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}]",Nutrients,['10.3390/nu12092888']
2843,32971921,Motor Control Stabilisation Exercise for Patients with Non-Specific Low Back Pain: A Prospective Meta-Analysis with Multilevel Meta-Regressions on Intervention Effects.,"Low-to-moderate quality meta-analytic evidence shows that motor control stabilisation exercise (MCE) is an effective treatment of non-specific low back pain. A possible approach to overcome the weaknesses of traditional meta-analyses would be that of a prospective meta-analyses. The aim of the present analysis was to generate high-quality evidence to support the view that motor control stabilisation exercises (MCE) lead to a reduction in pain intensity and disability in non-specific low back pain patients when compared to a control group. In this prospective meta-analysis and sensitivity multilevel meta-regression within the MiSpEx-Network, 18 randomized controlled study arms were included. Participants with non-specific low back pain were allocated to an intervention (individualized MCE, 12 weeks) or a control group (no additive exercise intervention). From each study site/arm, outcomes at baseline, 3 weeks, 12 weeks, and 6 months were pooled. The outcomes were current pain (NRS or VAS, 11 points scale), characteristic pain intensity, and subjective disability. A random effects meta-analysis model for continuous outcomes to display standardized mean differences between intervention and control was performed, followed by sensitivity multilevel meta-regressions. Overall, 2391 patients were randomized; 1976 (3 weeks, short-term), 1740 (12 weeks, intermediate), and 1560 (6 months, sustainability) participants were included in the meta-analyses. In the short-term, intermediate and sustainability, moderate-to-high quality evidence indicated that MCE has a larger effect on current pain (SMD = -0.15, -0.15, -0.19), pain intensity (SMD = -0.19, -0.26, -0.26) and disability (SMD = -0.15, -0.27, -0.25) compared with no exercise intervention. Low-quality evidence suggested that those patients with comparably intermediate current pain and older patients may profit the most from MCE. Motor control stabilisation exercise is an effective treatment for non-specific low back pain. Sub-clinical intermediate pain and middle-aged patients may profit the most from this intervention.",2020,"Participants with non-specific low back pain were allocated to an intervention (individualized MCE, 12 weeks) or a control group (no additive exercise intervention).","['2391 patients were randomized; 1976 (3 weeks, short-term), 1740 (12 weeks, intermediate), and 1560 (6 months, sustainability) participants were included in the meta-analyses', 'Patients with Non-Specific Low Back Pain', 'non-specific low back pain', 'Participants with non-specific low back pain', 'Sub-clinical intermediate pain and middle-aged patients', 'non-specific low back pain patients']","['Motor control stabilisation exercise', 'motor control stabilisation exercise (MCE', 'intervention (individualized MCE, 12 weeks) or a control group (no additive exercise intervention', 'motor control stabilisation exercises (MCE', 'MCE', 'Motor Control Stabilisation Exercise']","['pain intensity', 'current pain', 'disability', 'pain intensity and disability', 'current pain (NRS or VAS, 11 points scale), characteristic pain intensity, and subjective disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282458', 'cui_str': 'Meta-Analysis'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442796', 'cui_str': 'Additive'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",2391.0,0.0427174,"Participants with non-specific low back pain were allocated to an intervention (individualized MCE, 12 weeks) or a control group (no additive exercise intervention).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Niederer', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University Frankfurt, 60487 Frankfurt am Main, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Engel', 'Affiliation': 'University Outpatient Clinic, Centre of Sports Medicine, University of Potsdam, 14469 Potsdam, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine and Exercise Physiology, Goethe University Frankfurt, 60487 Frankfurt am Main, Germany.'}, {'ForeName': 'Adamantios', 'Initials': 'A', 'LastName': 'Arampatzis', 'Affiliation': 'Department of Training and Movement Sciences, Humboldt-Universität zu Berlin, 10115 Berlin, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Goethe University Frankfurt, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Beck', 'Affiliation': 'University Hospital Carl Gustav Carus at Technical University Dresden, 01307 Dresden, Germany.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Moreno Catalá', 'Affiliation': 'Department of Training and Movement Sciences, Humboldt-Universität zu Berlin, 10115 Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brenner-Fliesser', 'Affiliation': 'Sociology of Physical Activity and Health, University of Potsdam, 14469 Potsdam, Germany.'}, {'ForeName': 'Claas', 'Initials': 'C', 'LastName': 'Güthoff', 'Affiliation': 'Centre for Clinical Research, Department of Trauma and Orthopaedic Surgery, Unfallkrankenhaus Berlin, 12683 Berlin, Germany.'}, {'ForeName': 'Thore', 'Initials': 'T', 'LastName': 'Haag', 'Affiliation': 'Orthopädiezentrum Theresie, 80339 München, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hönning', 'Affiliation': 'Centre for Clinical Research, Department of Trauma and Orthopaedic Surgery, Unfallkrankenhaus Berlin, 12683 Berlin, Germany.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Pfeifer', 'Affiliation': 'Pain Management, Center of Orthopaedics and Trauma Surgery, Heidelberg University Hospital, 69118 Heidelberg, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Platen', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, 44801 Bochum, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Schiltenwolf', 'Affiliation': 'Pain Management, Center of Orthopaedics and Trauma Surgery, Heidelberg University Hospital, 69118 Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schneider', 'Affiliation': 'Orthopädiezentrum Theresie, 80339 München, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Trompeter', 'Affiliation': 'Department of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, 44801 Bochum, Germany.'}, {'ForeName': 'Pia-Maria', 'Initials': 'PM', 'LastName': 'Wippert', 'Affiliation': 'Sociology of Physical Activity and Health, University of Potsdam, 14469 Potsdam, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Mayer', 'Affiliation': 'University Outpatient Clinic, Centre of Sports Medicine, University of Potsdam, 14469 Potsdam, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9093058']
2844,32972179,"Anticoagulation therapy in cancer associated thromboembolism - new studies, new guidelines.","Low molecular weight heparin (LMWH) has become a standard of treatment of cancer-associated thromboembolism (CAT). Until recently, direct oral anticoagulants (DOAC) have not had data about efficacy and safety in cancer patients. However, in the last two years, four randomized open-label studies comparing DOAC and LMWH in the treatment of CAT have been published. The first one was a large trial with edoxaban, followed by two smaller studies with rivaroxaban and apixaban, and, recently, by another large trial with apixaban. There are some differences among the studies concerning design, inclusion and exclusion criteria, length of treatment. In summary, DOAC are associated with a trend to the reduction of the risk of recurrence of venous thromboembolism; however, this is at the expense of some increase in bleeding risk. This risk is differential; the prevailing site of bleeding is the upper part of gastrointestinal tract, and, to a lesser extent, genitourinary tract. The updated guidelines for the treatment of CAT suggest DOAC as an alternative, however with careful consideration of the risk of bleeding and the risk of drug interactions. So far, the guidelines have mentioned edoxaban and rivaroxaban. With emerging evidence, apixaban is expected to play a role as well.",2020,"In summary, DOAC are associated with a trend to the reduction of the risk of recurrence of venous thromboembolism; however, this is at the expense of some increase in bleeding risk.",['cancer patients'],"['rivaroxaban', 'edoxaban', 'rivaroxaban and apixaban', 'Anticoagulation therapy', 'apixaban', 'Low molecular weight heparin (LMWH']","['bleeding risk', 'risk of recurrence of venous thromboembolism']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",,0.0241,"In summary, DOAC are associated with a trend to the reduction of the risk of recurrence of venous thromboembolism; however, this is at the expense of some increase in bleeding risk.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hirmerová', 'Affiliation': ''}]",Vnitrni lekarstvi,[]
2845,32972259,"Threat appraisals, neuroticism, and intrusive memories: a robust mediational approach with replication.","Background:  The appraisal of a stressor substantially influences how we adapt to it. We used an experimental paradigm to test and replicate the effects of threat appraisals on subsequent intrusive memories, as well as their moderation by neuroticism.  Method : In three studies (total  N  = 562), participants were randomly assigned to an aversive or control video and then asked to report their threat appraisals of the video. Intrusive memories were assessed at one, three, five, and seven days. We used a robust framework for testing causal mediational effects and their magnitude, including sensitivity analyses and new effect size metrics.  Results:  We found that threat appraisals mediated the effect of the video on intrusive memories (studies 1-3), and for people higher in neuroticism, the causal mediational pathway was stronger (study 1 and 2).  Conclusions:  These findings provide methodologically strong evidence that threat appraisals have causal effects on subsequent intrusive memories and that neuroticism enhances this effect, lending empirical support to appraisal theories of posttraumatic stress disorder.",2020,"We found that threat appraisals mediated the effect of the video on intrusive memories (studies 1-3), and for people higher in neuroticism, the causal mediational pathway was stronger (study 1 and 2).  ",[],['aversive or control video'],"['Intrusive memories', 'Threat appraisals, neuroticism, and intrusive memories']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0561837', 'cui_str': 'Intrusive memories'}, {'cui': 'C1842981', 'cui_str': 'Neuroticism Traits'}]",,0.0397423,"We found that threat appraisals mediated the effect of the video on intrusive memories (studies 1-3), and for people higher in neuroticism, the causal mediational pathway was stronger (study 1 and 2).  ","[{'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Mancini', 'Affiliation': 'Department of Psychology, Pace University, Pleasantville, NY, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Aldrich', 'Affiliation': 'Department of Psychology, New York University, NY, USA.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Shevorykin', 'Affiliation': 'Department of Psychology, Pace University, Pleasantville, NY, USA.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Veith', 'Affiliation': 'Department of Psychology, Pace University, Pleasantville, NY, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'John', 'Affiliation': 'Department of Psychology, Pace University, Pleasantville, NY, USA.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1825693']
2846,32968371,Oral Nifidepine versus IV labetalol in severe preeclampsia: A randomized control trial.,"Objective


To compare oral Nifidepine and IV labetalol in terms of rapidity of BP control in severe preeclampsia.
Methods


All patients coming to Services Hospital from March 2017 to February 2019 with diagnosis of severe preeclampsia ≥ 24 weeks gestation were randomized to either receive Nifidepine or Labetalol. Primary outcome measure was time taken to control BP and number of doses required. Secondary outcome measures were side effects of drugs, APGAR score, NICU admission and perinatal mortality.
Results


Two hundred four patients were included in trial with 102 patients in each group. Labetalol took 22.6± 13.5minutes and Nifidepine took 22.09± 11.7 minutes to achieve target BP (p>0.05). Labetalol required 2.3± 1.58 doses and Nifidepine 2.2± 1.58 doses to control BP ( p>0.05). No maternal side effects were seen in 86 (84.31%) and 92(90.19%) patients in both groups (p>0.05). Mean gestational age at birth was 34.8 ±2.73weeks in Labetalol and 35.2±2.48 weeks in Nifidepine group (p>0.05). In labetalol group, 43 (42.15%) babies had APGAR Score < 7/10 and 23(22.54%) babies required admission to NICU while in Nifidepine group 42 (41.17%) babies had Apgar score < 7/10 & 30(29.4%) babies were admitted to NICU(p>0.05). There were 21(20.5%) perinatal deaths in labetalol Group-And 19(18.6%) in Nifidepine group (p>0.05).
Conclusion


Oral Nifidepine and IV labetalol are equally efficacious in controlling BP in patients with severe pre eclampsia without any significant side effects.",2020,No maternal side effects were seen in 86 (84.31%) and 92(90.19%) patients in both groups (p>0.05).,"['Two hundred four patients were included in trial with 102 patients in each group', 'severe preeclampsia', 'patients coming to Services Hospital from March 2017 to February 2019 with diagnosis of severe preeclampsia ≥', '24 weeks gestation', 'patients with severe pre eclampsia']","['Oral Nifidepine versus IV labetalol', 'Nifidepine and IV labetalol', 'Labetalol', 'Nifidepine', 'Nifidepine or Labetalol', 'labetalol']","['APGAR Score', 'time taken to control BP and number of doses required', 'Mean gestational age at birth', 'side effects of drugs, APGAR score, NICU admission and perinatal mortality', 'perinatal deaths', 'maternal side effects']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0341950', 'cui_str': 'Severe pre-eclampsia'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}]","[{'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",204.0,0.0630709,No maternal side effects were seen in 86 (84.31%) and 92(90.19%) patients in both groups (p>0.05).,"[{'ForeName': 'Tayyiba', 'Initials': 'T', 'LastName': 'Wasim', 'Affiliation': 'Dr. Tayyiba Wasim, FCPS, Department of Gynecology, Services Institute of Medical Sciences, Lahore, Pakistan.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Agha', 'Affiliation': 'Dr. Shazia Agha, FCPS, Department of Gynecology, Services Institute of Medical Sciences, Lahore, Pakistan.'}, {'ForeName': 'Kanwal', 'Initials': 'K', 'LastName': 'Saeed', 'Affiliation': 'Dr. Kanwal Saeed, FCPS-I, Department of Gynecology, Services Institute of Medical Sciences, Lahore, Pakistan.'}, {'ForeName': 'Anam', 'Initials': 'A', 'LastName': 'Riaz', 'Affiliation': 'Dr. Anam Riaz, FCPS-I, Department of Gynecology, Services Institute of Medical Sciences, Lahore, Pakistan.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.6.2591']
2847,32968383,Effectiveness of Pre-operative Respiratory Muscle Training versus Conventional Treatment for Improving Post operative Pulmonary Health after Coronary Artery Bypass Grafting.,"Objective


To evaluate the Effectiveness of Pre-operative Respiratory Muscle Training versus Conventional Treatment for Improving post-operative pulmonary health after Coronary Artery Bypass Graft Surgery (CABG).
Methods


A Prospective Randomized clinical trial was performed on sixty patients who underwent elective CABG at Faisalabad Institute of Cardiology. At the time of admission all patients were subjected to 6-minutes' walk test (6MWT) as baseline. The subjects were then divided into two groups. The Group-I was subjected to respiratory muscle training whereas the Group-2 received the routine preoperative care. The 6-minute walk test (6MWT) was then repeated a day before surgery (pre-operative) and before discharge (post-operatively). Duration of post-operative mechanical ventilation, oxygen therapy and hospital stay were also noted as outcome measures of this study.
Results


The pre-operative and post-operative readings showed that the patients in the interventional group performed better than the control group in their 6MWT with P-value of less than 0.05. Similarly the interventional group had shorter duration of mechanical ventilation, dependence on oxygen therapy and postoperative hospital stay as compared with the control group showing P-values below 0.05.
Conclusion


The results showed that respiratory muscle training results in improved postoperative functional capacity and reduces of hospital stay.",2020,The pre-operative and post-operative readings showed that the patients in the interventional group performed better than the control group in their 6MWT with P-value of less than 0.05.,"['post-operative pulmonary health after Coronary Artery Bypass Graft Surgery (CABG', 'sixty patients who underwent elective CABG at Faisalabad Institute of Cardiology', 'Post operative Pulmonary Health after Coronary Artery Bypass Grafting']","['respiratory muscle training whereas the Group-2 received the routine preoperative care', 'Pre-operative Respiratory Muscle Training versus Conventional Treatment']","['Duration of post-operative mechanical ventilation, oxygen therapy and hospital stay', 'postoperative functional capacity and reduces of hospital stay', 'shorter duration of mechanical ventilation, dependence on oxygen therapy and postoperative hospital stay', 'pre-operative and post-operative readings', '6-minute walk test (6MWT']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033061', 'cui_str': 'Preoperative care'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C4523862', 'cui_str': 'Dependence on oxygen therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}]",60.0,0.0295927,The pre-operative and post-operative readings showed that the patients in the interventional group performed better than the control group in their 6MWT with P-value of less than 0.05.,"[{'ForeName': 'Wajeeha', 'Initials': 'W', 'LastName': 'Sahar', 'Affiliation': 'Wajeeha Sahar, Department of Physiotherapy, Faisalabad Institute of Cardiology, Faisalabad, Pakistan.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Ajaz', 'Affiliation': 'Noor Ajaz, KKT-Orthopedic and Spine Center, Faisalabad, Pakistan.'}, {'ForeName': 'Zulfiqar', 'Initials': 'Z', 'LastName': 'Haider', 'Affiliation': 'Zulfiqar Haider, FRCS-CTh. Punjab Institute of Cardiology, Lahore, Pakistan. Department of Cardiac Surgery, Punjab Institute of Cardiology, Jail Road, Lahore, Pakistan.'}, {'ForeName': 'Anjum', 'Initials': 'A', 'LastName': 'Jalal', 'Affiliation': 'Anjum Jalal, FRCS-CTh. Office of the Executive Director, Faisalabad Institute of Cardiology, Faisalabad, Pakistan.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.6.2899']
2848,32968390,Trauma Evaluation and Management TEAM® course for medical students in Pakistan.,"Objectives


To assess the immediate effect of TEAM® on trauma related knowledge of undergraduate medical students and to highlight the stakeholders' acceptability of TEAM® for trauma training of undergraduate medical students.
Methods


Effectiveness of TEAM® course in terms of knowledge gain was assessed using 20-item-MCQs at three different timings to three cohorts of medical students from year 2017 (Group A), 2018 (Group B) and 2019 (Group C). Group A attempted the test after traditional teaching in wards, Group B attempted it after reading books and videos of TEAM®, along with traditional trauma teaching. Finally Group C attempted the test after TEAM® course along with videos and books. Students and faculty also filled evaluation questionnaire for their acceptability assessment. Kruskal-Wallis Test was applied for comparison between scores of the three groups. The evaluation questionnaire of students as well as for faculty was evaluated by determining frequencies and percentages.
Results


A statistically significant difference is found after comparing the scores of the three groups (p< 0.00). More than 85% of the students were of a view that this course would help in their future practice and application. Similarly, 80% of the faculty would prefer to be involved in TEAM® teaching in future.
Conclusion


There is an improvement in trauma cognitive knowledge, after the TEAM® program. Students and faculty strongly supported its introduction in the undergraduate curriculum and hence acceptable to both.",2020,"There is an improvement in trauma cognitive knowledge, after the TEAM® program.","['medical students in Pakistan', 'undergraduate medical students']",['TEAM®'],"['knowledge gain', 'trauma cognitive knowledge']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",,0.0268781,"There is an improvement in trauma cognitive knowledge, after the TEAM® program.","[{'ForeName': 'Rufina', 'Initials': 'R', 'LastName': 'Soomro', 'Affiliation': 'Dr. Rufina Soomro, MBBS, FCPS. Department of General Surgery, Liaquat National Hospital & Medical College, Karachi, Pakistan.'}, {'ForeName': 'Sobia', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Dr. Sobia Ali, MBBS, MHPE. Department of Health Professions Education, Liaquat National Hospital & Medical College, Karachi, Pakistan.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.6.2588']
2849,32968415,Repair of non-traumatic femoral head necrosis by marrow core decompression with bone grafting and porous tantalum rod implantation.,"Objective


To compare the clinical effects of marrow core decompression with bone grafting and marrow core decompression with porous tantalum rod implantation in treating avascular necrosis of non-traumatic femoral head.
Methods


This prospective study selected 60 patients (74 hips) with avascular necrosis of femoral head admitted to Daping Hospital from January 2018 to March 2019. According to treatment methods, the 60 patients were randomly divided into two groups, i.e. 30 patients in one group were treated by marrow core decompression with bone grafting, and the other 30 patients in the other group were treated with marrow core decompression and porous tantalum rod implantation.
Results


All implantation treatments were successful. No significant difference was found in surgical duration, hemorrhage volume and duration of hospitalization stay between the two groups during follow-up. All Harris scores were significantly improved (P<0.05) following treatment compared to those before treatment. The Harris score of patients treated with porous tantalum rod implantation was higher than that of patients treated with bone grafting (P<0.05) after 12 months following treatment and such a difference was significant.
Conclusion


The combination of marrow core decompression and porous tantalum rod implantation can better improve the functions of hip joints with early femoral head necrosis than marrow core decompression with bone grafting, and can also prevent articular cartilage from collapsing gradually.",2020,"No significant difference was found in surgical duration, hemorrhage volume and duration of hospitalization stay between the two groups during follow-up.","['60 patients', '60 patients (74 hips) with avascular necrosis of femoral head admitted to Daping Hospital from January 2018 to March 2019']","['marrow core decompression and porous tantalum rod implantation', 'marrow core decompression with bone grafting and marrow core decompression with porous tantalum rod implantation', 'marrow core decompression with bone grafting', 'marrow core decompression with bone grafting and porous tantalum rod implantation']","['surgical duration, hemorrhage volume and duration of hospitalization stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0039297', 'cui_str': 'Tantalum'}, {'cui': 'C0035086', 'cui_str': 'Renal osteodystrophy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",60.0,0.0222394,"No significant difference was found in surgical duration, hemorrhage volume and duration of hospitalization stay between the two groups during follow-up.","[{'ForeName': 'Keyun', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': 'Keyun Peng, Orthopedic Central Joint and Limb Surgery, Army Medical Center of PLA (Daping Hospital), Army Medical University, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Yu Wang, Orthopedic Central Joint and Limb Surgery, Army Medical Center of PLA (Daping Hospital), Army Medical University, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Jifeng Zhu, Orthopedic Central Joint and Limb Surgery, Army Medical Center of PLA (Daping Hospital), Army Medical University, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Chengling', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Chengling Li, Orthopedic Central Joint and Limb Surgery, Army Medical Center of PLA (Daping Hospital), Army Medical University, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Ziming Wang, Orthopedic Central Joint and Limb Surgery, Army Medical Center of PLA (Daping Hospital), Army Medical University, Yuzhong District, Chongqing, China.'}]",Pakistan journal of medical sciences,['10.12669/pjms.36.6.2176']
2850,32968425,Remote ischaemic preconditioning influences the levels of acylcarnitines in vascular surgery: a randomised clinical trial.,"Background


Vascular surgery patients have reduced tissues` blood supply, which may lead to mitochondrial dysfunction and accumulation of acylcarnitines (ACs). It has been suggested that remote ischaemic preconditioning (RIPC) has its organ protective effect via promoting mitochondrial function. The aim of this study was to evaluate the effect of RIPC on the profile of ACs in the vascular surgery patients.
Methods


This is a randomised, sham-controlled, double-blinded, single-centre study. Patients undergoing open surgical repair of abdominal aortic aneurysm, surgical lower limb revascularisation surgery or carotid endarterectomy were recruited non-consecutively. The RIPC protocol consisting of 4 cycles of 5 min of ischaemia, followed by 5 min of reperfusion, was applied. A blood pressure cuff was used for RIPC or a sham procedure. Blood was collected preoperatively and approximately 24 h postoperatively. The profile of ACs was analysed using the AbsoluteIDQp180 kit (Biocrates Life Sciences AG, Innsbruck, Austria).
Results


Ninety-eight patients were recruited and randomised into the study groups and 45 patients from the RIPC group and 47 patients from the sham group were included in final analysis. There was a statistically significant difference between the groups regarding the changes in C3-OH ( p  = 0.023)-there was a decrease (- 0.007 µmol/L, ± 0.020 µmol/L,  p  = 0.0233) in the RIPC group and increase (0.002 µmol/L, ± 0.015 µmol/L,  p  = 0.481) in the sham group. Additionally, a decrease from baseline to 24 h after surgery ( p  < 0.05) was detected both in the sham and the RIPC group in the levels of following ACs: C2, C8, C10, C10:1, C12, C12:1, C14:1, C14:2, C16, C16:1, C18, C18:1, C18:2. In the sham group, there was an increase ( p  < 0.05) in the levels of C0 (carnitine) and a decrease in the level of C18:1-OH. In the RIPC group, a decrease ( p  < 0.05) was noted in the levels of C3-OH, C3-DC (C4-OH), C6:1, C9, C10:2.
Conclusions


It can be concluded that RIPC may have an effect on the levels of ACs and might therefore have protective effects on mitochondria in the vascular surgery patients. Further larger studies conducted on homogenous populations are needed to make more definite conclusions about the effect of RIPC on the metabolism of ACs.
Trial registration


ClinicalTrials.gov database, NCT02689414. Registered 24 February 2016-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02689414.",2020,"In the RIPC group, a decrease ( p  < 0.05) was noted in the levels of C3-OH, C3-DC (C4-OH), C6:1, C9, C10:2.
","['Ninety-eight patients were recruited and randomised into the study groups and 45 patients from the RIPC group and 47 patients from the sham group were included in final analysis', 'vascular surgery patients', 'vascular surgery', 'Patients undergoing open surgical repair of abdominal aortic aneurysm, surgical lower limb revascularisation surgery or carotid endarterectomy were recruited non-consecutively', '\n\n\nVascular surgery patients']","['Remote ischaemic preconditioning', 'RIPC']","['level of C18:1-OH', 'levels of C3-OH, C3-DC (C4-OH), C6:1, C9, C10:2', 'levels of C0 (carnitine', 'C3-OH', 'blood pressure cuff']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}]",98.0,0.45311,"In the RIPC group, a decrease ( p  < 0.05) was noted in the levels of C3-OH, C3-DC (C4-OH), C6:1, C9, C10:2.
","[{'ForeName': 'Teele', 'Initials': 'T', 'LastName': 'Kasepalu', 'Affiliation': 'Department of Surgery, Institute of Clinical Medicine, University of Tartu, Puusepa 8, 50406 Tartu, Estonia.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kuusik', 'Affiliation': 'Department of Biochemistry, Institute of Biomedicine and Translational Medicine, Centre of Excellence for Genomics and Translational Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Urmas', 'Initials': 'U', 'LastName': 'Lepner', 'Affiliation': 'Department of Surgery, Institute of Clinical Medicine, University of Tartu, Puusepa 8, 50406 Tartu, Estonia.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Starkopf', 'Affiliation': 'Tartu University Hospital, Tartu, Estonia.'}, {'ForeName': 'Mihkel', 'Initials': 'M', 'LastName': 'Zilmer', 'Affiliation': 'Department of Biochemistry, Institute of Biomedicine and Translational Medicine, Centre of Excellence for Genomics and Translational Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Jaan', 'Initials': 'J', 'LastName': 'Eha', 'Affiliation': 'Department of Cardiology, Institute of Clinical Medicine, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Mare', 'Initials': 'M', 'LastName': 'Vähi', 'Affiliation': 'Institute of Mathematics and Statistics, University of Tartu, Tartu, Estonia.'}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Kals', 'Affiliation': 'Department of Surgery, Institute of Clinical Medicine, University of Tartu, Puusepa 8, 50406 Tartu, Estonia.'}]",Nutrition & metabolism,['10.1186/s12986-020-00495-3']
2851,32968544,"An app-, web- and social support-based weight loss intervention for adults with obesity: the 'HelpMeDoIt!' feasibility randomised controlled trial.","Background


Social support has an important role in successful weight loss. The aim of this study was to assess the feasibility and acceptability of an app-, web- and social support-based intervention in supporting adults with obesity to achieve weight loss.
Methods


The intervention and evaluation methods were tested in a feasibility randomised controlled trial. Adults in the Greater Glasgow and Clyde Health Board area of Scotland with a body mass index ≥ 30 kg/m 2  were recruited and randomised 2:1 (intervention to control). The feasibility and acceptability of the intervention and trial methods were assessed against pre-specified progression criteria, via process, economic and outcome evaluation. Three primary outcomes were explored: BMI, diet and physical activity, as well as a number of secondary outcomes. The intervention group had access to the HelpMeDoIt! intervention for 12 months. This encouraged them to (i) set goals, (ii) monitor progress and (iii) harness social support by inviting 'helpers' from their existing social network. The control group received a healthy lifestyle leaflet.
Results


One hundred and nine participants were recruited, with 84 participants (77%) followed-up at 12 months. The intervention and trial methods were feasible and acceptable. Participants and helpers were generally positive. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it. Interview data indicated that HelpMeDoIt! promoted social support from existing social networks to support weight loss. This support was often given outside of the app.Outcomes were compared using linear regression models, with randomised group, the baseline measurement of the outcome, age and gender as predictor variables. These analyses were exploratory and underpowered to detect effects. However, all pre-specified primary outcome effects (BMI, diet and physical activity) had wide confidence intervals and were therefore consistent with clinically relevant benefits. Objective physical activity measures perhaps showed most potential (daily step count ( p  = 0.098; 1187 steps [- 180, 2555])) and sedentary time ( p  = 0.022; - 60.8 min [- 110.5, - 11.0]). However, these outcomes were poorly completed.
Conclusions


The study demonstrated that a novel social support intervention involving support from participants' close social networks, delivered via app and website, has potential to promote weight loss and is feasible and acceptable.
Trial registration


ISRCTN, ISRCTN85615983. Registered 25 September 2014.",2020,"Objective physical activity measures perhaps showed most potential (daily step count ( p  = 0.098; 1187 steps [- 180, 2555])) and sedentary time ( p  = 0.022; - 60.8 min [- 110.5, - 11.0]).","['adults with obesity', 'One hundred and nine participants were recruited, with 84 participants (77%) followed-up at 12\u2009months', 'Adults in the Greater Glasgow and Clyde Health Board area of Scotland with a body mass index ≥\u200930\u2009kg/m 2', 'adults with obesity to achieve weight loss']","['novel social support intervention', 'HelpMeDoIt', 'app-, web- and social support-based weight loss intervention', 'app-, web- and social support-based intervention', 'healthy lifestyle leaflet']","['sedentary time', 'Objective physical activity measures', 'feasibility and acceptability', 'BMI, diet and physical activity, as well as a number of secondary outcomes', 'effects (BMI, diet and physical activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",109.0,0.1362,"Objective physical activity measures perhaps showed most potential (daily step count ( p  = 0.098; 1187 steps [- 180, 2555])) and sedentary time ( p  = 0.022; - 60.8 min [- 110.5, - 11.0]).","[{'ForeName': 'Sharon Anne', 'Initials': 'SA', 'LastName': 'Simpson', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley Street, Glasgow, G3 7HR UK.'}, {'ForeName': 'Lynsay', 'Initials': 'L', 'LastName': 'Matthews', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley Street, Glasgow, G3 7HR UK.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Pugmire', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley Street, Glasgow, G3 7HR UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Robertson Centre, Boyd Orr Building, Glasgow, G12 8QQ UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Health Economics and Health Technology Assessment Unit (HEHTA), Institute of Health and Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ UK.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park Way, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hughes', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park Way, Cardiff, CF14 4YS UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kelson', 'Affiliation': 'College of Engineering, Mathematics and Physical Sciences, School of Mathematics/The Alan Turing Institute, University of Exeter, Harrison Building, Streatham Campus, North Park Road, Exeter, EX4 4QF UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Morgan-Trimmer', 'Affiliation': ""Institute of Health Research, College of Medicine and Health, University of Exeter, College House, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), Cardiff School of Social Sciences, Cardiff University, Cardiff, CF10 3AT UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Utkina-Macaskill', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley Street, Glasgow, G3 7HR UK.'}, {'ForeName': 'Laurence Anthony Russell', 'Initials': 'LAR', 'LastName': 'Moore', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Berkeley Square, 99 Berkeley Street, Glasgow, G3 7HR UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00656-4']
2852,32968565,Does Point of Care Ultrasound Improve Resuscitation Markers in Undifferentiated Hypotension? An International Randomized Controlled Trial From The Sonography in Hypotension and Cardiac Arrest in the Emergency Department (SHoC-ED) Series.,"Introduction Point of Care Ultrasound (PoCUS) protocols are commonly used to guide resuscitation for patients with undifferentiated hypotension, yet there is a paucity of evidence for any outcome benefit. We undertook an international multicenter randomized controlled trial (RCT) to assess the impact of a PoCUS protocol on key clinical outcomes. Here we report on resuscitation markers.  Methods Adult patients presenting to six emergency departments (ED) in Canada and South Africa with undifferentiated hypotension (systolic blood pressure (SBP) <100mmHg or a Shock Index >1.0) were randomized to receive a PoCUS protocol or standard care (control). Reported physiological markers include shock index (SI), and modified early warning score (MEWS), with biochemical markers including venous bicarbonate and lactate, at baseline and four hours.  Results A total of 273 patients were enrolled, with data collected for 270. Baseline characteristics were similar for each group. Improvements in mean values for each marker during initial treatment were similar between groups: Shock Index; mean reduction in Control 0.39, 95% CI 0.34 to 0.44 vs. PoCUS 0.33, 0.29 to 0.38; MEWS, mean reduction in Control 2.56, 2.22 to 2.89 vs. PoCUS 2.91, 2.49 to 3.32; Bicarbonate, mean reduction in Control 2.71 mmol/L, 2.12 to 3.30 mmol/L vs. PoCUS 2.30 mmol/L, 1.75 to 2.84 mmol/L, and venous lactate, mean reduction in Control 1.39 mmol/L, 0.93 to 1.85 mmol/L vs. PoCUS 1.31 mmol/L, 0.88 to 1.74 mmol/L. Conclusion We found no meaningful difference in physiological and biochemical resuscitation markers with or without the use of a PoCUS protocol in the resuscitation of undifferentiated hypotensive ED patients. We are unable to exclude improvements in individual patients or in specific shock types.",2020,"Improvements in mean values for each marker during initial treatment were similar between groups: Shock Index; mean reduction in Control 0.39, 95% CI 0.34 to 0.44 vs. PoCUS 0.33, 0.29 to 0.38; MEWS, mean reduction in Control 2.56, 2.22 to 2.89 vs. PoCUS 2.91, 2.49 to 3.32; Bicarbonate, mean reduction in Control 2.71 mmol/L, 2.12 to 3.30 mmol/L vs. PoCUS 2.30 mmol/L, 1.75 to 2.84 mmol/L, and venous lactate, mean reduction in Control 1.39 mmol/L, 0.93 to 1.85 mmol/L vs. PoCUS 1.31 mmol/L, 0.88 to 1.74 mmol/L. Conclusion","['273 patients were enrolled, with data collected for 270', 'Methods Adult patients presenting to six emergency departments (ED)\xa0in Canada and South Africa with undifferentiated hypotension (systolic blood pressure (SBP', 'undifferentiated hypotensive ED patients']","['Care Ultrasound (PoCUS) protocols', 'PoCUS protocol or standard care (control', 'PoCUS protocol']","['physiological markers include shock index (SI), and modified early warning score (MEWS), with biochemical markers including\xa0venous bicarbonate and lactate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2919784', 'cui_str': 'Modified early warning score'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",273.0,0.116562,"Improvements in mean values for each marker during initial treatment were similar between groups: Shock Index; mean reduction in Control 0.39, 95% CI 0.34 to 0.44 vs. PoCUS 0.33, 0.29 to 0.38; MEWS, mean reduction in Control 2.56, 2.22 to 2.89 vs. PoCUS 2.91, 2.49 to 3.32; Bicarbonate, mean reduction in Control 2.71 mmol/L, 2.12 to 3.30 mmol/L vs. PoCUS 2.30 mmol/L, 1.75 to 2.84 mmol/L, and venous lactate, mean reduction in Control 1.39 mmol/L, 0.93 to 1.85 mmol/L vs. PoCUS 1.31 mmol/L, 0.88 to 1.74 mmol/L. Conclusion","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Atkinson', 'Affiliation': 'Emergency Medicine, Saint John Regional Hospital, Saint John, CAN.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'Emergency Medicine, Saint John Regional Hospital, Saint John, CAN.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Milne', 'Affiliation': 'Family Medicine, Fraser Valley Health, Vancouver, CAN.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Diegelmann', 'Affiliation': 'Emergency Medicine, University of Maryland, Baltimore, USA.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Lamprecht', 'Affiliation': 'Emergency Medicine, Stellenbosch University, Cape Town, ZAF.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Stander', 'Affiliation': 'Emergency Medicine, Mediclinic, Cape Town, ZAF.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lussier', 'Affiliation': 'Emergency Medicine, University of Manitoba, Winnipeg, CAN.'}, {'ForeName': 'Chau', 'Initials': 'C', 'LastName': 'Pham', 'Affiliation': 'Emergency Medicine, University of Manitoba, Winnipeg, CAN.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Henneberry', 'Affiliation': 'Emergency Medicine, Dalhousie University, Halifax, CAN.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Fraser', 'Affiliation': 'Emergency Medicine, Saint John Regional Hospital, Saint John, CAN.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Howlett', 'Affiliation': 'Emergency Medicine, Saint John Regional Hospital, Saint John, CAN.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Mekwan', 'Affiliation': 'Emergency Medicine, Horizon Health Network, Saint John, CAN.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ramrattan', 'Affiliation': 'Emergency Medicine, Dalhousie University, Saint John, CAN.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Middleton', 'Affiliation': 'Emergency Medicine, Saint John Regional Hospital, Saint John, CAN.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Van Hoving', 'Affiliation': 'Emergency Medicine, Stellenbosch University, Cape Town, ZAF.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Peach', 'Affiliation': 'Emergency Medicine, Dalhousie University, Saint John, CAN.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Dahn', 'Affiliation': 'Emergency Medicine, Dalhousie University, Halifax, CAN.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Hurley', 'Affiliation': 'Emergency Medicine, Dalhousie University, Halifax, CAN.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'MacSween', 'Affiliation': 'Emergency Medicine, Dalhousie University, Halifax, CAN.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Richardson', 'Affiliation': 'Emergency Medicine, Dalhousie University, Halifax, CAN.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Stoica', 'Affiliation': 'Research Services, Horizon Health Network, Saint John, CAN.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Hunter', 'Affiliation': 'Science, University of Ottawa, Ottawa, CAN.'}, {'ForeName': 'Jack P', 'Initials': 'JP', 'LastName': 'Atkinson', 'Affiliation': 'Faculty of Science, Dalhousie University, Halifax, CAN.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Olszynski', 'Affiliation': 'Emergency Medicine, University of Saskatchewan, Saskatoon, CAN.'}, {'ForeName': 'Ankona', 'Initials': 'A', 'LastName': 'Banerjee', 'Affiliation': 'Medical Services, WorkSafeNB, Saint John, CAN.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Emergency Medicine, Dalhousie University, Saint John, CAN.'}]",Cureus,['10.7759/cureus.9899']
2853,32968804,Effects of Oral Contraception and Lifestyle Modification on Incretins and TGF-ß Superfamily Hormones in PCOS.,"OBJECTIVE


To examine effects of common treatments for PCOS on a panel of hormones(reproductive/metabolic).
DESIGN


Secondary analysis of blood from a RCT of three 16-week preconception interventions designed to improve PCOS-related abnormalities: continuous oral contraceptives(OCP, N=34 subjects), intensive lifestyle modification(Lifestyle, N =31) or combination of both(Combined, N=29).
MATERIALS AND METHODS


Post-treatment levels of activin A and B, inhibin B and follistatin as well as IGF-1, IGFBP-2, glucagon, GLP-1 and 2 and Oxyntomodulin were compared to baseline and change from baseline in these parameters were correlated with outcomes.
RESULTS


OCP use was associated with a significant suppression in activin A, inhibin A and AMH, but significant increase in follistatin. IGF-1, IGFBP-2, glucagon and GLP-2 levels were significantly decreased. Oxyntomodulin was profoundly suppressed by OCP[ratio of geometric means: 0.09, 95% CI(0.05, 0.18),p<.001]. None of the analytes were significantly affected by Lifestyle; whereas, effects of Combined were similar to OCP alone, although attenuated. Oxyntomodulin was significantly positively associated with change in total ovarian volume[rs = 0.27; 95% CI: (0.03, 0.48);p=0.03] and insulin sensitivity index[rs = 0.48; 95% CI: (0.27, 0.64);p<.001] and inversely correlated with change in AUC glucose[rs = -0.38; 95% CI: (-0.57, -0.16);p=0.001]. None of the hormonal changes were associated with live birth, only Activin A was associated with ovulation[risk ratio per 1 ng/mL increase in change in Activin A: 6.0(2.2, 16.2); p<.001].
CONCLUSIONS


In women with PCOS, OCP(and not Lifestyle) affects a wide variety of reproductive/metabolic hormones, but their treatment response does not correlate with live birth.",2020,"IGF-1, IGFBP-2, glucagon and GLP-2 levels were significantly decreased.",[],"['intensive lifestyle modification(Lifestyle, N =31) or combination of both(Combined, N=29', 'Oral Contraception and Lifestyle Modification']","['activin A, inhibin A and AMH', 'live birth', 'Oxyntomodulin', 'follistatin', 'activin A and B, inhibin B and follistatin as well as IGF-1, IGFBP-2, glucagon, GLP-1 and 2 and Oxyntomodulin', 'IGF-1, IGFBP-2, glucagon and GLP-2 levels']",[],"[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0100748', 'cui_str': 'Activin A'}, {'cui': 'C0883157', 'cui_str': 'Inhibin A'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0086379', 'cui_str': 'Glicentin (33-69)'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0971174', 'cui_str': 'Inhibin B'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123257', 'cui_str': 'Insulin-like growth factor binding protein 2'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0912332', 'cui_str': 'Glucagon-like peptide 2'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.174059,"IGF-1, IGFBP-2, glucagon and GLP-2 levels were significantly decreased.","[{'ForeName': 'Aesha', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Dodson', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Penny M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, Penn State College of Health and Human Development, University Park, PA.'}, {'ForeName': 'Allen R', 'Initials': 'AR', 'LastName': 'Kunselman', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Christy M', 'Initials': 'CM', 'LastName': 'Stetter', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Gnatuk', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Estes', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Allison', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Sarwer', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Sluss', 'Affiliation': 'Department of Pathology, Massachusetts General Hospital, Boston, MA TX.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology (AD, CC), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Dokras', 'Affiliation': 'Department of Obstetrics and Gynecology (AD, CC), Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, PA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa682']
2854,32968914,Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout.,"BACKGROUND


Transrectal Natural Orifice Transluminal Endoscopic Surgery is currently limited by the inherent risk of surgical site infection due to peritoneal contamination after rectotomy. Coloshield has been developed as a temporary colon occlusion device to facilitate rectal washout. However, effectiveness and safety has not been evaluated in humans.
METHODS


Twenty-two patients have been randomly assigned to undergo proctological intervention with a rectal washout with and without the use of Coloshield. Patients and assessors were blinded. Boston Bowel Preparation Scale (BBPS) has been determined 30 min as well as immediately after rectal washout. Feasibility, pain, intra- and postoperative morbidity as well as bowel function and continence 6 weeks after surgery were assessed.
RESULTS


BBPS 30 min after rectal washout with and without Coloshield was in mean 2.42 ± 1.02 and 2.12 ± 0.89 (p = 0.042). Mean BBPS immediately after rectal washout was 2.39 ± 1.02 and 2.24 ± 0.66 (p = 0.269). Mean BBPS immediately after rectal washout and 30 min thereafter did not differ (p = 0.711). Coloshield application was feasible without any complications. The median (interquartile range) numeric rating scale for pain 4 h after surgery was 1 (0-1) and 3 (0-4) (p = 0.212). Six weeks after surgery 0/11 and 1/11 patients suffered from evacuation difficulties (p = 1.0) and the median Vaizey-Wexner score was 1 (0-3) and 1 (0-2) (p = 0.360).
CONCLUSIONS


Coloshield application in humans is feasible and safe. Slight benefits in rectal preparation by washout are found when Coloshield is used. Colon occlusion by Coloshield for transrectal NOTES should be evaluated within clinical studies.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02579330.",2020,Mean BBPS immediately after rectal washout and 30 min thereafter did not differ (p = 0.711).,['Twenty-two patients have been randomly assigned to undergo'],"['proctological intervention with a rectal washout with and without the use of Coloshield', 'colon-occlusion device']","['median (interquartile range) numeric rating scale for pain', 'median Vaizey-Wexner score', 'effectiveness and safety', 'Feasibility, pain, intra- and postoperative morbidity', 'Boston Bowel Preparation Scale (BBPS', 'Mean BBPS']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0193144', 'cui_str': 'Rectal irrigation'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0235328', 'cui_str': 'Obstruction of colon'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.257171,Mean BBPS immediately after rectal washout and 30 min thereafter did not differ (p = 0.711).,"[{'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Cordewener', 'Affiliation': 'Pelvic Floor Unit, Clarunis, University Center for Gastrointestinal and Liver Diseases, 4002, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Zürcher', 'Affiliation': 'Department of Surgery, Spital Thun STS AG, Krankenhausstrasse 12, 3600, Thun, Switzerland.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Müller', 'Affiliation': 'Department of Visceral and Transplantation Surgery, University Hospital Zürich, Rämistrasse 100, 8032, Zurich, Switzerland.'}, {'ForeName': 'Beat P', 'Initials': 'BP', 'LastName': 'Müller-Stich', 'Affiliation': 'Department of Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zerz', 'Affiliation': 'eSwiss Medical and Surgical Center, Klinik Stephanshorn, Brauerstrasse 97, 9016, St. Gallen, Switzerland.'}, {'ForeName': 'Georg R', 'Initials': 'GR', 'LastName': 'Linke', 'Affiliation': 'Department of Surgery, Spital Thun STS AG, Krankenhausstrasse 12, 3600, Thun, Switzerland.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Steinemann', 'Affiliation': 'Pelvic Floor Unit, Clarunis, University Center for Gastrointestinal and Liver Diseases, 4002, Basel, Switzerland. Daniel.steinemann@unibas.ch.'}]",Surgical endoscopy,['10.1007/s00464-020-07992-9']
2855,32968915,A comparative prospective study of short-term outcomes of extended view totally extraperitoneal (e-TEP) repair versus laparoscopic intraperitoneal on lay mesh (IPOM) plus repair for ventral hernia.,"BACKGROUND


Currently, minimally invasive approach is preferred for the treatment of ventral hernias. After the introduction of extended view totally extraperitoneal (e-TEP) technique, there has been a constant debate over the choice of better approach. In this study, we compare the short-term outcomes of e-TEP and laparoscopic IPOM Plus repair for ventral hernias.
METHODS


This is a comparative, prospective single-center study done at GEM Hospital and research center Coimbatore, India from July 2018 to July 2019. All patients who underwent elective ventral hernia surgery with defect size of 2 to 6 cm were included. Patient demographics, hernia characteristics, operative and perioperative findings, and postoperative complications were systematically recorded and analyzed.
RESULTS


We evaluated 92 cases (n = 92), 46 in each group. Mean age, sex, BMI, location of hernia, primary and incisional hernia, and comorbidity were comparable in both the groups. Mean defect size for IPOM Plus and e-TEP was 4 cm and 3.89 cm, respectively. Operative time was significantly higher for e-TEP, while postoperative pain (VAS), analgesic requirement, and postoperative hospital stay were significantly less as compared to IPOM Plus. However, 2 cases (4.35%) of e-TEP had recurrence but none in IPOM Plus group.
CONCLUSION


e-TEP is an evolving procedure and comparable to IPOM Plus in terms of postoperative pain, analgesic requirement, cost of mesh, and length of hospital stay. More randomized controlled and multicentric studies are required with longer follow-up to validate our findings.",2020,"Operative time was significantly higher for e-TEP, while postoperative pain (VAS), analgesic requirement, and postoperative hospital stay were significantly less as compared to IPOM","['92 cases (n\u2009=\u200992), 46 in each group', 'ventral hernia', 'All patients who underwent elective ventral hernia surgery with defect size of 2 to 6\xa0cm were included']","['e-TEP and laparoscopic IPOM Plus repair', 'extended view totally extraperitoneal ', 'IPOM', 'e-TEP) repair versus laparoscopic intraperitoneal on lay mesh (IPOM) plus repair']","['Mean age, sex, BMI, location of hernia, primary and incisional hernia, and comorbidity', 'Operative time', 'postoperative pain, analgesic requirement, cost of mesh, and length of hospital stay', 'postoperative pain (VAS), analgesic requirement, and postoperative hospital stay', 'Patient demographics, hernia characteristics, operative and perioperative findings, and postoperative complications', 'Mean defect size for IPOM']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0852648,"Operative time was significantly higher for e-TEP, while postoperative pain (VAS), analgesic requirement, and postoperative hospital stay were significantly less as compared to IPOM","[{'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'GEM Hospital and Research Centre, Coimbatore, India. neeraj891677@yahoo.com.'}, {'ForeName': 'Nalankilli V', 'Initials': 'NV', 'LastName': 'Palanisamy', 'Affiliation': 'GEM Hospital and Research Centre, Coimbatore, India.'}, {'ForeName': 'Ramakrishnan', 'Initials': 'R', 'LastName': 'Parthasarathi', 'Affiliation': 'GEM Hospital and Research Centre, Coimbatore, India.'}, {'ForeName': 'Sandeep C', 'Initials': 'SC', 'LastName': 'Sabnis', 'Affiliation': 'GEM Hospital and Research Centre, Coimbatore, India.'}, {'ForeName': 'Sunil Kumar', 'Initials': 'SK', 'LastName': 'Nayak', 'Affiliation': 'GEM Hospital and Research Centre, Coimbatore, India.'}, {'ForeName': 'Chinnusamy', 'Initials': 'C', 'LastName': 'Palanivelu', 'Affiliation': 'GEM Hospital and Research Centre, Coimbatore, India.'}]",Surgical endoscopy,['10.1007/s00464-020-07990-x']
2856,32968933,"Artificial Intelligence-Assisted Colonoscopy for Detection of Colon Polyps: a Prospective, Randomized Cohort Study.","BACKGROUND AND AIMS


Improving the rate of polyp detection is an important measure to prevent colorectal cancer (CRC). Real-time automatic polyp detection systems, through deep learning methods, can learn and perform specific endoscopic tasks previously performed by endoscopists. The purpose of this study was to explore whether a high-performance, real-time automatic polyp detection system could improve the polyp detection rate (PDR) in the actual clinical environment.
METHODS


The selected patients underwent same-day, back-to-back colonoscopies in a random order, with either traditional colonoscopy or artificial intelligence (AI)-assisted colonoscopy performed first by different experienced endoscopists (> 3000 colonoscopies). The primary outcome was the PDR. It was registered with clinicaltrials.gov . (NCT047126265).
RESULTS


In this study, we randomized 150 patients. The AI system significantly increased the PDR (34.0% vs 38.7%, p < 0.001). In addition, AI-assisted colonoscopy increased the detection of polyps smaller than 6 mm (69 vs 91, p < 0.001), but no difference was found with regard to larger lesions.
CONCLUSIONS


A real-time automatic polyp detection system can increase the PDR, primarily for diminutive polyps. However, a larger sample size is still needed in the follow-up study to further verify this conclusion.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT047126265.",2020,"The AI system significantly increased the PDR (34.0% vs 38.7%, p < 0.001).",['150 patients'],"['traditional colonoscopy or artificial intelligence (AI)-assisted colonoscopy performed first by different experienced endoscopists', 'Artificial Intelligence-Assisted Colonoscopy']","['detection of polyps smaller', 'polyp detection rate (PDR', 'PDR']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",150.0,0.114583,"The AI system significantly increased the PDR (34.0% vs 38.7%, p < 0.001).","[{'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Tongyin', 'Initials': 'T', 'LastName': 'Xing', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Aiming', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Yadong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Xiaobei', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China. luoxiaobei63@126.com.'}, {'ForeName': 'Side', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China. liuside2011@163.com.'}, {'ForeName': 'Zelong', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China. hzl198886@163.com.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-020-04802-4']
2857,32968936,Effectiveness of Atorvastatin in the Treatment of Asymptomatic Heart Failure After Myocardial Infarction: A Clinical Study.,"INTRODUCTION


Silent heart failure after myocardial infarction has not been effectively treated. Atorvastatin has certain efficacy in the treatment of heart failure. Our clinical study aimed to investigate the effectiveness of atorvastatin in patients with asymptomatic heart failure after myocardial infarction.
METHODS


A total of 162 patients with asymptomatic heart failure after myocardial infarction in our hospital from August 2018 to August 2019 were randomly divided into the observation group (81 cases were treated with atorvastatin on the basis of routine therapy) and the control group (81 cases were treated with routine symptomatic treatment). The clinical curative effect, the level of related inflammatory cytokines, cardiac function index, and vascular endothelial function were compared between the two groups.
RESULTS


Before intervention, there was no significant difference in tumor necrosis factor (TNFα), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), plasma N-terminal B-type natriuretic peptide (NT-ProBNP), left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), left ventricular posterior wall thickness (LVPWT), asymmetric dimethyarginine (ADMA), activity of nitric oxide synthase (NOS), nitric oxide (NO) and flow-mediated dilation (FMD) between the two groups. After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups. The clinical curative effect, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD in the observation group showed significantly greater results than those in the control group (P < 0.05).
CONCLUSION


Atorvastatin exerted a great effect in treating asymptomatic heart failure after myocardial infarction, which can evidently reduce the level of related inflammatory cytokines, improve cardiac function, and regulate vascular endothelial function. Hence, atorvastatin is considered a valid and alternative approach in clinical practice.",2020,"After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups.","['Asymptomatic Heart Failure', 'heart failure', 'After Myocardial Infarction', 'patients with asymptomatic heart failure after myocardial infarction', '162 patients with asymptomatic heart failure after myocardial infarction in our hospital from August 2018 to August 2019']","['Atorvastatin', 'atorvastatin']","['clinical curative effect, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD', 'level of related inflammatory cytokines, cardiac function index, and vascular endothelial function', 'TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD', 'tumor necrosis factor (TNFα), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), plasma N-terminal B-type natriuretic peptide (NT-ProBNP), left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), left ventricular posterior wall thickness (LVPWT), asymmetric dimethyarginine (ADMA), activity of nitric oxide synthase (NOS), nitric oxide (NO) and flow-mediated dilation (FMD']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",162.0,0.0159963,"After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Ran', 'Initials': 'XR', 'LastName': 'Cui', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Yang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. 13933058601@163.com.'}, {'ForeName': 'Ji-Dong', 'Initials': 'JD', 'LastName': 'Zhang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}]",Advances in therapy,['10.1007/s12325-020-01441-8']
2858,32969040,"A randomised crossover trial of closed loop automated oxygen control in preterm, ventilated infants.","AIM


To determine if closed loop automated oxygen control resulted in a reduction in the duration and severity of desaturation episodes and the number of blood gases and chest radiographs in preterm, ventilated infants.
METHODS


Infants were studied on two consecutive days for 12 hours on each day. They were randomised to receive standard care (standard period) or standard care with a closed loop automated oxygen control system (automated oxygen control period) first.
RESULTS


Twenty-four infants with a median gestational age of 25.7 (range 23.1 - 32.6) weeks were studied at a median postconceptional age of 27.4 (range 24.3 - 34.9) weeks. During the automated oxygen control period, there were fewer desaturations that lasted > 30seconds (p=0.032) or > 60seconds (p= 0.002), infants spent a higher proportion of the time within their target SpO 2  range during the automated oxygen control period (p<0.001) and fewer manual adjustments were made to the inspired oxygen concentration (mean 0.58 versus mean 11.29) (p. <0.001). There were no significant differences in the number of blood gases (p=0.872) or chest radiographs (p= 0.366) between the two periods.
CONCLUSION


Closed loop automated oxygen delivery resulted in fewer prolonged desaturations with more time spent in the targeted oxygen range.",2020,"There were no significant differences in the number of blood gases (p=0.872) or chest radiographs (p= 0.366) between the two periods.
","['Infants were studied on two consecutive days for 12 hours on each day', 'preterm, ventilated infants', 'Twenty-four infants with a median gestational age of 25.7 (range 23.1 - 32.6) weeks were studied at a median postconceptional age of 27.4 (range 24.3 - 34.9) weeks']","['standard care (standard period) or standard care with a closed loop automated oxygen control system (automated oxygen control period) first', 'closed loop automated oxygen control']","['inspired oxygen concentration', 'duration and severity of desaturation episodes and the number of blood gases and chest radiographs', 'number of blood gases (p=0.872) or chest radiographs']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5192328', 'cui_str': '27.4'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0428648', 'cui_str': 'Inspired oxygen concentration'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",24.0,0.161216,"There were no significant differences in the number of blood gases (p=0.872) or chest radiographs (p= 0.366) between the two periods.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sturrock', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, UK.""}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Ambulkar', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, UK.""}, {'ForeName': 'Emma E', 'Initials': 'EE', 'LastName': 'Williams', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, UK.""}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sweeney', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, UK.""}, {'ForeName': 'Nadja F', 'Initials': 'NF', 'LastName': 'Bednarczuk', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, UK.""}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Dassios', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, UK.""}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15585']
2859,32969104,Development and evaluation of an adapted physical activity program in anorexia nervosa inpatients: A pilot study.,"BACKGROUND AND CONTEXT


Problematic use of physical activity is frequent in subjects with anorexia nervosa (AN). Although it increases resistance to therapeutic treatment, paradoxically, physical activity in AN can also improve mental and physical health. Based on the literature review we hypothesized that adding an adapted physical activity (APA) program to treatment programs could be more beneficial than a total suppression of physical activities. We designed this open study to evaluate the outcome of AN inpatients after an APA program implementation as well as the perceived effect of APA.
METHOD


Forty-one women with AN (17.2 (±2.5) years old, BMI of 16.86 (±2.0)) were included. An eight-session (1 h30/session/week) standardized APA program was delivered and evaluated by structured questionnaires assessing exercise dependence, perceived physical activity, eating disorder (ED) symptoms, body mass index (BMI), along with an interview before and after the APA program.
RESULTS


Twenty-nine women complete the PA program and evaluation. BMI and perceived PA score significantly increased, ED and exercise dependence scores significantly decreased (p < .01). Participants appreciated the program.
DISCUSSION/CONCLUSION


The inpatient program which included APA program helped AN inpatients in decreasing their ED symptoms and their dependence to PA, without any deleterious effect on BMI. Furthermore, APA was appreciated by participants. HIGHLIGHTS : An adapted physical activity (APA) program which contained an educational component was specifically designed for anorexia nervosa (AN) inpatients and showed beneficial outcomes. The tested APA program did not constrain the body mass index increase in AN inpatients. The dependence to PA of the AN inpatients and their eating disorder symptoms were significantly decreased after the completion of the present APA program. The participants appreciated the proposed APA program. This study clearly pleads to conducting a multicentre randomized controlled trial in order to extend the present results into full clinical impacts.",2020,"BMI and perceived PA score significantly increased, ED and exercise dependence scores significantly decreased (p < .01).","['Forty-one women with AN (17.2 (±2.5) years old, BMI of 16.86 (±2.0)) were included', 'anorexia nervosa inpatients', 'anorexia nervosa (AN) inpatients', 'Twenty-nine women complete the PA program and evaluation', 'subjects with anorexia nervosa (AN']",['adapted physical activity program'],"['ED and exercise dependence scores', 'eating disorder symptoms', 'structured questionnaires assessing exercise dependence, perceived physical activity, eating disorder (ED) symptoms, body mass index (BMI', 'BMI and perceived PA score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",41.0,0.0146208,"BMI and perceived PA score significantly increased, ED and exercise dependence scores significantly decreased (p < .01).","[{'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Kern', 'Affiliation': 'EA 2931, LINP2-APSA, Université Paris Nanterre, Nanterre, France.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Morvan', 'Affiliation': 'EA 4430 CLIPSYD Clinique Psychanalyse Développement, Université Paris Nanterre, Nanterre, France.'}, {'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Mattar', 'Affiliation': 'Nutrition Program, Department of Natural Sciences, Lebanese American University, Beirut, Lebanon.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Molina', 'Affiliation': 'EA 4430 CLIPSYD Clinique Psychanalyse Développement, Université Paris Nanterre, Nanterre, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tailhardat', 'Affiliation': 'EA 2931, LINP2-APSA, Université Paris Nanterre, Nanterre, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Peguet', 'Affiliation': 'EA 2931, LINP2-APSA, Université Paris Nanterre, Nanterre, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'De Tournemire', 'Affiliation': 'CHI Poissy Saint Germain, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Hirot', 'Affiliation': ""Service hospitalo-universitaire de santé mentale de l'adolescent et du jeune adulte de la FSEF Paris, Paris, France.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Rizk', 'Affiliation': 'INSERM U1178, Maison de Solenn, Paris, France.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Godart', 'Affiliation': ""Service hospitalo-universitaire de santé mentale de l'adolescent et du jeune adulte de la FSEF Paris, Paris, France.""}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Fautrelle', 'Affiliation': 'Institut National Universitaire Champollion, STAPS, Équipe Interdisciplinaire en Activités Physiques, Rodez, France.'}]",European eating disorders review : the journal of the Eating Disorders Association,['10.1002/erv.2779']
2860,32969169,"Battlefield acupuncture added no benefit as an adjunct analgesic in emergency department for abdominal, low back or limb trauma pain.","OBJECTIVES


To ascertain whether ear acupuncture (modified Battlefield technique) as an adjunct (Adj-BFA) to standard analgesia care (SAC) significantly reduces pain scores compared with sham acupuncture (Adj-Sham) or SAC alone, when delivered by medical and nursing practitioners in an ED.
METHODS


A randomised controlled trial using a convenience sample of 90 patients attending an ED with acute abdominal, limb trauma or low back pain were allocated to three treatment arms: Adj-BFA, Adj-Sham and SAC. The primary outcome of change in pain scores out-of-10 (NPRS-10) from triage were assessed immediately after intervention and at 1 and 2 h post-intervention. Secondary outcomes were the percentage of patients reporting 'adequate analgesia' or ≥30% reduction in pain score, analgesic medication use (in morphine equivalent dose [milligrammes]), analgesics and needle costs (Australian dollars), adverse effects and patient satisfaction (Likert scale).
RESULTS


There was no significant difference in pain scores (P = 0.582) or secondary outcomes measures between Adj-BFA, Adj-Sham and SAC.
CONCLUSION


The present study on 90 patients did not show a significant difference in analgesia outcomes in the first 2 h using Adj-BFA for acute pain in the ED, and there were no significant differences for secondary outcomes between treatment arms. Given the mixed results of recent BFA trials, further research using the original BFA technique on different painful conditions, as either stand-alone or as-adjunct to non-opioid analgesia are needed before BFA can be recommended as a technique for acute pain management in the ED.",2020,"There was no significant difference in pain scores (P = 0.582) or secondary outcomes measures between Adj-BFA, Adj-Sham and SAC","['emergency department for abdominal, low back or limb trauma pain', '90 patients attending an ED with acute abdominal, limb trauma or low back pain', '90 patients']","['Battlefield acupuncture', 'Adj-BFA, Adj-Sham and SAC', 'ear acupuncture (modified Battlefield technique', 'sham acupuncture (Adj-Sham) or SAC alone', 'standard analgesia care (SAC', 'SAC']","[""percentage of patients reporting 'adequate analgesia' or ≥30% reduction in pain score, analgesic medication use (in morphine equivalent dose [milligrammes]), analgesics and needle costs (Australian dollars), adverse effects and patient satisfaction (Likert scale"", 'analgesia outcomes', 'pain scores', 'change in pain scores out-of-10 (NPRS-10']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0752217', 'cui_str': 'Ear Acupuncture'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0562019', 'cui_str': 'dollar'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",90.0,0.250603,"There was no significant difference in pain scores (P = 0.582) or secondary outcomes measures between Adj-BFA, Adj-Sham and SAC","[{'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Jan', 'Affiliation': 'School of Medicine, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Emogene S', 'Initials': 'ES', 'LastName': 'Aldridge', 'Affiliation': 'Emergency Department, St John of God Murdoch Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Visser', 'Affiliation': 'Chronic Pain Education and Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Rogers', 'Affiliation': 'School of Medicine, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Hince', 'Affiliation': 'Department of Biostatistics, Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Woosey', 'Affiliation': 'Emergency Department, St John of God Murdoch Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Max K', 'Initials': 'MK', 'LastName': 'Bulsara', 'Affiliation': 'Department of Biostatistics, Institute for Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Lorna Kp', 'Initials': 'LK', 'LastName': 'Suen', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}]",Emergency medicine Australasia : EMA,['10.1111/1742-6723.13642']
2861,32969197,Weight Reduction Through a Cognitive Behavioral Therapy Lifestyle Intervention in PCOS: The Primary Outcome of a Randomized Controlled Trial.,"OBJECTIVE


Long-term weight loss is important and difficult to achieve for many women with polycystic ovary syndrome (PCOS). Lifestyle interventions (LS) in PCOS have shown moderate short-term effects. Three-component LS that combine nutrition advice, exercise, and cognitive behavioral therapy have not been tested in long-term interventions.
METHODS


Women (N = 183) with PCOS who were trying to conceive and had BMI > 25 kg/m 2  were assigned to 20 group sessions of cognitive behavioral therapy combined with nutrition advice and exercise (LS with or without Short Message Service [SMS] via mobile phone) or care as usual (CAU).
RESULTS


More weight loss was observed in LS than in CAU (P < 0.001). Adding SMS was even more effective (P = 0.017). In CAU, 13 of 60 (21.8%) succeeded in achieving a 5% weight loss, as did 32 of 60 (52.8%) in LS without SMS and 54 of 63 (85.7%) in LS with SMS. The odds of achieving a 5% weight loss were 7.0 (P < 0.001) in LS compared with CAU. More than 18 of 60 (29.0%) of the women in CAU gained weight versus 5 of 60 (8.5%) and 2 of 63 (3.1%) in LS without or with SMS, respectively. The overall dropout rate was 116 of 183 (63.4%).
CONCLUSIONS


A three-component LS program resulted in reasonable weight loss in women with PCOS. Adding SMS resulted in more weight loss.",2020,The odds of achieving a 5% weight loss were 7.0 (P < 0.001) in LS compared with CAU.,"['Women (N\u2009=\u2009183) with PCOS who were trying to conceive and had BMI\u2009>\u200925 kg/m 2', 'PCOS', 'women with polycystic ovary syndrome (PCOS', 'women with PCOS']","['SMS', 'cognitive behavioral therapy combined with nutrition advice and exercise (LS with or without Short Message Service [SMS] via mobile phone) or care as usual (CAU', 'Lifestyle interventions (LS', 'Cognitive Behavioral Therapy Lifestyle Intervention']","['weight loss', 'overall dropout rate', 'odds of achieving a 5% weight loss', 'Weight Reduction', 'reasonable weight loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0420843', 'cui_str': 'Trying to conceive'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0444892', 'cui_str': 'CAU'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",183.0,0.128628,The odds of achieving a 5% weight loss were 7.0 (P < 0.001) in LS compared with CAU.,"[{'ForeName': 'Geranne', 'Initials': 'G', 'LastName': 'Jiskoot', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Timman', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Annemerle', 'Initials': 'A', 'LastName': 'Beerthuizen', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dietz de Loos', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Busschbach', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'Laven', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, the Netherlands.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22980']
2862,32972467,Efficacy of a transdiagnostic cognitive-behavioral intervention for eating disorder psychopathology delivered through a smartphone app: a randomized controlled trial.,"BACKGROUND


Although effective treatments exist for diagnostic and subthreshold-level eating disorders (EDs), a significant proportion of affected individuals do not receive help. Interventions translated for delivery through smartphone apps may be one solution towards reducing this treatment gap. However, evidence for the efficacy of smartphones apps for EDs is lacking. We developed a smartphone app based on the principles and techniques of transdiagnostic cognitive-behavioral therapy for EDs and evaluated it through a pre-registered randomized controlled trial.
METHODS


Symptomatic individuals (those who reported the presence of binge eating) were randomly assigned to the app (n = 197) or waiting list (n = 195). Of the total sample, 42 and 31% exhibited diagnostic-level bulimia nervosa and binge-eating disorder symptoms, respectively. Assessments took place at baseline, 4 weeks, and 8 weeks post-randomization. Analyses were intention-to-treat. The primary outcome was global levels of ED psychopathology. Secondary outcomes were other ED symptoms, impairment, and distress.
RESULTS


Intervention participants reported greater reductions in global ED psychopathology than the control group at post-test (d = -0.80). Significant effects were also observed for secondary outcomes (d's = -0.30 to -0.74), except compensatory behavior frequency. Symptom levels remained stable at follow-up. Participants were largely satisfied with the app, although the overall post-test attrition rate was 35%.
CONCLUSION


Findings highlight the potential for this app to serve as a cost-effective and easily accessible intervention for those who cannot receive standard treatment. The capacity for apps to be flexibly integrated within current models of mental health care delivery may prove vital for addressing the unmet needs of people with EDs.",2020,"Significant effects were also observed for secondary outcomes (d's = -0.30 to -0.74), except compensatory behavior frequency.",['Symptomatic individuals (those who reported the presence of binge eating'],"['transdiagnostic cognitive-behavioral intervention', 'transdiagnostic cognitive-behavioral therapy', 'waiting list']","['Symptom levels', 'global ED psychopathology', 'ED symptoms, impairment, and distress', 'overall post-test attrition rate', 'diagnostic-level bulimia nervosa and binge-eating disorder symptoms', 'global levels of ED psychopathology']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}]",,0.216814,"Significant effects were also observed for secondary outcomes (d's = -0.30 to -0.74), except compensatory behavior frequency.","[{'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Linardon', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Street, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Shatte', 'Affiliation': 'Federation University, School of Science, Engineering & Information Technology, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rosato', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Street, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Street, Geelong, VIC 3220, Australia.'}]",Psychological medicine,['10.1017/S0033291720003426']
2863,32972478,A service evaluation of a group mindfulness-based intervention for distressing voices: how do findings from a randomized controlled trial compare with routine clinical practice?,"BACKGROUND


Person-based cognitive therapy (PBCT) was developed as a treatment for psychosis. The effectiveness of group PBCT was examined in the Mindfulness for Voices (M4V) randomized controlled trial and generated promising results. Group PBCT was implemented as a trans-diagnostic treatment for distressing voices within the Sussex Voices Clinic (SVC), a specialist secondary care mental health service.
AIM


To conduct a service evaluation of engagement, outcomes and cost of group PBCT within SVC, and to compare engagement and outcomes from routine practice with the M4V trial. Secondary aims were to explore predictors of levels of engagement and change in group PBCT.
METHOD


Service level data from 95 SVC patients were evaluated. Descriptive statistics, hypothesis tests and linear regression models were used. The primary clinical outcome was voice-related distress. Engagement levels and pre-post effect sizes were estimated; associated predictors were explored.
RESULTS


Fifty-nine per cent of patients completed group PBCT within SVC, compared with 72% within M4V. Completers within SVC had lower baseline depression scores compared with non-completers. There were significant improvements in voice-related distress (Cohen's d = -0.47; p = 0.001), subjective recovery (Cohen's d = 0.35; p = 0.001) and depression (Cohen's d = -0.20; p = 0.044); these outcomes were comparable to M4V. Higher baseline subjective recovery and lower depression both predicted improvement in voice-related distress. Therapy within SVC cost an average of £214 per patient.
CONCLUSION


PBCT groups can be delivered trans-diagnostically in routine clinical practice. Engagement was lower when compared with an RCT, but outcomes were comparable. The low level of resources involved suggests that group PBCT can offer value for money.",2020,"There were significant improvements in voice-related distress (Cohen's d = -0.47; p = 0.001), subjective recovery (Cohen's d = 0.35; p = 0.001) and depression (Cohen's d = -0.20; p = 0.044); these outcomes were comparable to M4V. Higher baseline subjective recovery and lower depression both predicted improvement in voice-related distress.","['Service level data from 95 SVC patients were evaluated', 'distressing voices']",['Person-based cognitive therapy (PBCT'],"['subjective recovery', 'depression', 'baseline depression scores', 'voice-related distress']","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.193533,"There were significant improvements in voice-related distress (Cohen's d = -0.47; p = 0.001), subjective recovery (Cohen's d = 0.35; p = 0.001) and depression (Cohen's d = -0.20; p = 0.044); these outcomes were comparable to M4V. Higher baseline subjective recovery and lower depression both predicted improvement in voice-related distress.","[{'ForeName': 'Anna-Marie', 'Initials': 'AM', 'LastName': 'Jones', 'Affiliation': 'R&D Department, Sussex Education Centre, Sussex Partnership NHS Foundation Trust, Nevill Avenue, HoveBN3 7HZ, UK.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Strauss', 'Affiliation': 'R&D Department, Sussex Education Centre, Sussex Partnership NHS Foundation Trust, Nevill Avenue, HoveBN3 7HZ, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hayward', 'Affiliation': 'R&D Department, Sussex Education Centre, Sussex Partnership NHS Foundation Trust, Nevill Avenue, HoveBN3 7HZ, UK.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000624']
2864,32972483,Tailoring cognitive behavioural therapy to subtypes of voice-hearing using a novel tabletised manual: a feasibility study.,"BACKGROUND


Cognitive behavioural therapy for psychosis (CBTp) is a recommended treatment for psychotic experiences, but its effectiveness has been questioned. One way of addressing this may be to tailor therapy materials to the phenomenology of specific psychotic experiences.
AIM


In this study, we investigated the acceptability of a novel treatment manual for subtypes of 'voice-hearing' experiences (i.e. auditory verbal hallucinations). An uncontrolled, single-arm design was used to assess feasibility and acceptability of using the manual in routine care for people with frequent voice-hearing experiences.
METHOD


The manual was delivered on a smart tablet and incorporated recent research evidence and theory into its psychoeducation materials. In total, 24 participants completed a baseline assessment; 19 started treatment, 15 completed treatment and 12 participants completed a follow-up assessment (after 10 sessions of using the manual).
RESULTS


Satisfaction with therapy scores and acceptability ratings were high, while completion rates suggested that the manual may be more appropriate for help with participants from Early Intervention in Psychosis services rather than Community Mental Health Teams.
CONCLUSION


Within-group changes in symptom scores suggested that overall symptom severity of hallucinations - but not other psychosis features, or beliefs about voices - are likely to be the most appropriate primary outcome for further evaluation in a full randomised controlled trial.",2020,"An uncontrolled, single-arm design was used to assess feasibility and acceptability of using the manual in routine care for people with frequent voice-hearing experiences.
","[""subtypes of 'voice-hearing' experiences (i.e. auditory verbal hallucinations"", '24 participants completed a baseline assessment; 19 started treatment, 15 completed treatment and 12 participants completed a follow-up assessment (after 10 sessions of using the manual', 'psychosis (CBTp', 'people with frequent voice-hearing experiences']","['Cognitive behavioural therapy', 'Tailoring cognitive behavioural therapy']",['acceptability ratings'],"[{'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C4273841', 'cui_str': 'Cognitive behavioral therapy for psychosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",24.0,0.0520713,"An uncontrolled, single-arm design was used to assess feasibility and acceptability of using the manual in routine care for people with frequent voice-hearing experiences.
","[{'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Dodgson', 'Affiliation': 'Northumberland, Tyne & Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Alderson-Day', 'Affiliation': 'Department of Psychology, Durham University, Durham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Smailes', 'Affiliation': 'Department of Psychology, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faye', 'Initials': 'F', 'LastName': 'Ryles', 'Affiliation': 'Northumberland, Tyne & Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Mayer', 'Affiliation': 'Department of Psychology, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Glen-Davison', 'Affiliation': 'Department of Psychology, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Mitrenga', 'Affiliation': 'Department of Psychology, Durham University, Durham, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Fernyhough', 'Affiliation': 'Department of Psychology, Durham University, Durham, UK.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465820000661']
2865,32972554,Targeted Left Ventricular Lead Implantation Strategy for Non-Left Bundle Branch Block Patients: The ENHANCE CRT Study.,"OBJECTIVES


This study compared clinical outcomes between an increased electrical delay in the left ventricular region (QLV)-based LV lead implantation approach (QLV arm) and anatomical implantation approach (control arm) in patients with non-left bundle branch block.
BACKGROUND


Limited data exist on cardiac resynchronization therapy effectiveness in patients with non-left bundle branch block. Clinicians generally deliver cardiac resynchronization therapy through an anatomical implantation approach; however, targeting the QLV may serve as an individualized implantation strategy in non-left bundle branch block patients.
METHODS


The study enrolled 248 subjects at 29 U.S. centers. Subjects were randomized in a 2:1 ratio between a QLV-based implantation approach and anatomical implantation approach and were implanted with a St. Jude Medical quadripolar cardiac resynchronization therapy defibrillator system. The primary endpoint was the clinical composite score after 12 months of follow-up.
RESULTS


The study analyzed 191 available subjects at 12 months of follow-up (128 QLV arm, 63 control arm). Of these, 39 subjects (26 in the QLV arm and 13 in the control arm) had heart failure events (8 cardiac deaths and 31 heart failure hospitalizations). Aside from New York Heart Association functional class, there were no other significant differences in baseline characteristics between the 2 arms. The responder rate at 12 months measured by the clinical composite score was 67.2% in the QLV arm and 73.0% in the control arm (p = 0.506).
CONCLUSIONS


Although patient-tailored left ventricular lead placement guided by QLV is promising, we observed no difference in outcome between the QLV-based implantation approach and the conventional anatomical implantation approach.",2020,"The responder rate at 12 months measured by the clinical composite score was 67.2% in the QLV arm and 73.0% in the control arm (p = 0.506).
","['Non-Left Bundle Branch Block Patients', '248 subjects at 29 U.S. centers', '191 available subjects at 12\xa0months of follow-up (128 QLV arm, 63 control arm', '39 subjects (26 in the QLV arm and 13 in the control arm) had heart failure events (8 cardiac deaths and 31 heart failure hospitalizations', 'patients with non-left bundle branch block']","['left ventricular region (QLV)-based LV lead implantation approach (QLV arm) and anatomical implantation approach (control arm', 'QLV-based implantation approach and anatomical implantation approach and were implanted with a St. Jude Medical quadripolar cardiac resynchronization therapy defibrillator system']","['responder rate', 'clinical composite score']","[{'cui': 'C0023211', 'cui_str': 'Left bundle branch block'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",248.0,0.102803,"The responder rate at 12 months measured by the clinical composite score was 67.2% in the QLV arm and 73.0% in the control arm (p = 0.506).
","[{'ForeName': 'Jagmeet P', 'Initials': 'JP', 'LastName': 'Singh', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts. Electronic address: jsingh@mgh.harvard.edu.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Berger', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Doshi', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lloyd', 'Affiliation': 'Emory University Hospital, Atlanta, Georgia.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Moore', 'Affiliation': 'St. John Hospital and Medical Center, Detroit, Michigan.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'North Mississippi Medical Center, Tupelo, Mississippi.'}, {'ForeName': 'Emile G', 'Initials': 'EG', 'LastName': 'Daoud', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2020.04.034']
2866,32972965,Effect of home-based newborn care on neonatal and infant mortality: a cluster randomised trial in India.,"BACKGROUND


Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates.
METHODS


This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms-SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at 'endline' period (2008-2009) assessed by an independent team from January to April 2010 in the study clusters.
FINDINGS


A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.
INTERPRETATION


Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births.
TRIAL REGISTRATION NUMBER


The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181).",2020,"The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.
","['five districts in India', 'sick neonates and young infants using']","['routine health services', 'oral and injectable antibiotics and community mobilisation', 'home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW', 'home-based newborn care']","['proportion of facility births', 'risk of neonatal mortality', 'neonatal and infant mortality rates', 'neonatal mortality', 'Baseline mortality rates', 'risks of early neonatal mortality, young infant mortality and infant mortality', 'risks of neonatal, early neonatal, young infant, infant mortality', 'neonatal and young infant mortality rates', 'neonatal and infant mortality']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021278', 'cui_str': 'Mortality, Infant'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1271991', 'cui_str': 'Early neonatal death'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",,0.0793595,"The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.
","[{'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Rasaily', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India reeta.rasaily@gmail.com.'}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Saxena', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Pandey', 'Affiliation': 'Patna Medical College Hospital (PMCH), Patna, India.'}, {'ForeName': 'Bishan S', 'Initials': 'BS', 'LastName': 'Garg', 'Affiliation': 'Mahatma Gandhi Institute of Medical Sciences (MGIMS), Wardha, India.'}, {'ForeName': 'Saraswati', 'Initials': 'S', 'LastName': 'Swain', 'Affiliation': 'National Institute of Applied Human Research & Development (NIAHRD), Cuttack, India.'}, {'ForeName': 'Sharad D', 'Initials': 'SD', 'LastName': 'Iyengar', 'Affiliation': 'Action Research and Training for Health (ARTH), Udaipur, India.'}, {'ForeName': 'Vinita', 'Initials': 'V', 'LastName': 'Das', 'Affiliation': 'King George Medical University (KGMU), Lucknow, India.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Patna Medical College Hospital (PMCH), Patna, India.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Mahatma Gandhi Institute of Medical Sciences (MGIMS), Wardha, India.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India.'}, {'ForeName': 'Shiv', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Indian Council of Medical Research (ICMR), New Delhi, India.'}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'National Institute of Medical Statistics, New Delhi, India.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Harshpal Singh', 'Initials': 'HS', 'LastName': 'Sachdev', 'Affiliation': 'Sitaram Bhartia Institute of Science and Research (SBISR), New Delhi, India.'}, {'ForeName': 'Mari Jeeva', 'Initials': 'MJ', 'LastName': 'Sankar', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Siddarth', 'Initials': 'S', 'LastName': 'Ramji', 'Affiliation': 'Maulana Azad Medical College (MAMC), New Delhi, India.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Paul', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Abhay T', 'Initials': 'AT', 'LastName': 'Bang', 'Affiliation': 'Society for Education, Action and Research in Community Health (SEARCH), Gadchiroli, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ global health,['10.1136/bmjgh-2017-000680']
2867,32973056,"Effectiveness of three-dimensional printed and virtual reality models in learning the morphology of craniovertebral junction deformities: a multicentre, randomised controlled study.","OBJECTIVES


To compare the effectiveness of three-dimensional printed (3DP), virtual reality (VR) and conventional normal physical (NP) models in clinical education regarding the morphology of craniovertebral junction (CVJ) deformities.
DESIGN


Prospective, multicentre, randomised controlled study.
SETTING


Three teaching hospitals in China.
PARTICIPANTS


One hundred and fifty-three participants in their first year of a 3-year medical residency programme.
INTERVENTIONS


All participants were randomised to one of the three groups to learn the morphology of CVJ deformities using 3DP, VR or NP models.
PRIMARY OUTCOME MEASURES


The objective outcomes were evaluated using three-level objective testing. In the first-level test, the participants were required to identify 15 anatomical landmarks on radiographs without CVJ deformities. In the second-level test, all participants were asked to identify the same 15 landmarks on radiographs showing classic CVJ deformities. In the third-level test, the participants were required to describe the key features of three classic cases of CVJ deformities depicted on radiographs. Each participant was also asked to answer four subjective questions to evaluate the importance and usefulness of the educational materials.
RESULTS


In the first-level test, the 3DP, VR and NP groups achieved similar correct rates. In the second-level test, the correct rate was higher in the 3DP group (82.1%±13.6%) than the VR and NP groups (76.9%±16.9% and 69.9%±20.0%, p=0.002). In the third-level test, the 3DP group achieved better correct rates regarding the description of key CVJ deformities features (66.2%±20.0%, p=0.049) than the other groups. The subjective tests showed that the 3DP model method was considered the most valuable approach for learning CVJ deformities.
CONCLUSIONS


The objective and subjective results show that the 3DP model is more effective teaching instrument than the NP model for learning the pathomorphology of CVJ deformities. The VR model also showed great efficacy, second to 3DP model, in improving participants' understanding of CVJ deformities.",2020,"In the third-level test, the 3DP group achieved better correct rates regarding the description of key CVJ deformities features (66.2%±20.0%, p=0.049) than the other groups.","['craniovertebral junction deformities', 'One hundred and fifty-three participants in their first year of a 3-year medical residency programme', 'Three teaching hospitals in China']","['CVJ deformities using 3DP, VR or NP models', 'three-dimensional printed (3DP), virtual reality (VR) and conventional normal physical (NP) models', 'three-dimensional printed and virtual reality models']","['CVJ deformities features', 'correct rate']","[{'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035184', 'cui_str': 'Medical Residency'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",153.0,0.0288685,"In the third-level test, the 3DP group achieved better correct rates regarding the description of key CVJ deformities features (66.2%±20.0%, p=0.049) than the other groups.","[{'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'Orthopaedic Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Surgery, Chinese Academy of Medical Sciences & Peking Union Medical College Plastic Surgery Hospital and Institute, Shijingshan District, Beijing, China.'}, {'ForeName': 'Haomin', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Orthopedic Surgery, Shanghai Jiaotong University Affiliated Sixth People Hospital South Campus, Shanghai, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Orthopaedic Surgery, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Orthopaedic Surgery, Shandong Provincial Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Orthopaedic Surgery, Shandong Provincial Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Orthopaedic Surgery, Peking Union Medical College Hospital, Beijing, China tianye2019trail@163.com.'}]",BMJ open,['10.1136/bmjopen-2020-036853']
2868,32973057,Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial.,"INTRODUCTION


Left bundle branch area pacing (LBBaP) has been accepted as a physiological pacing method that can yield narrow paced QRS waves. For patients with failed biventricular pacing (Bi-V), LBBaP is another feasible option. However, no randomised controlled study has evaluated the efficacy and safety of LBBaP in heart failure patients with left bundle branch block (LBBB). Therefore, we aimed to conduct this type of randomised controlled trial.
METHODS AND ANALYSIS


This study is a single-centre, randomised controlled non-inferiority trial. This study will be conducted at the cardiac centre of Beijing Anzhen Hospital. From January 2020 to December 2022, 180 heart failure patients with reduced left ventricular ejection fraction (LVEF ≤35%) and LBBB undergoing Bi-V implantation will be consecutively enrolled in this study. Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V). The primary outcome is LVEF. The secondary outcomes are NT-proBNP, duration of the QRS complex, end systolic volume, end diastolic volume, the 6-minute walking test and quality of life (SF-36 scale), all causes of mortality, cardiovascular death, rehospitalisation rate of heart failure, other rehospitalisation rates, major complication rates, procedure costs and hospitalised dates.
ETHICS AND DISSEMINATION


This study has been approved by the Beijing Anzhen Hospital Medical Ethics Committee (No. ks201932). The results of this study will be presented at domestic and international conferences. We hypothesise that LBBaP is non-inferior compared with Bi-V for treating patients with heart failure and LBBB. This trial will provide evidence-based recommendations for electrophysiologists.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR2000028726).",2020,Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V).,"['patients with heart failure and LBBB', 'heart failure patients with left bundle branch block (LBBB', 'heart failure patients with left bundle branch block', 'From January 2020 to December 2022, 180 heart failure patients with reduced left ventricular ejection fraction (LVEF ≤35%) and LBBB undergoing Bi-V implantation will be consecutively enrolled in this study', 'cardiac centre of Beijing Anzhen Hospital']","['left bundle branch area pacing versus biventricular pacing', 'Left bundle branch area pacing (LBBaP', 'LBBaP']","['LVEF', 'Efficacy and safety', 'NT-proBNP, duration of the QRS complex, end systolic volume, end diastolic volume, the 6-minute walking test and quality of life (SF-36 scale), all causes of mortality, cardiovascular death, rehospitalisation rate of heart failure, other rehospitalisation rates, major complication rates, procedure costs and hospitalised dates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0023211', 'cui_str': 'Left bundle branch block'}, {'cui': 'C0006384', 'cui_str': 'Bundle branch block'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0459156', 'cui_str': 'Left bundle branch structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C2936372', 'cui_str': 'Biventricular Pacing'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}]","[{'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0429097', 'cui_str': 'QRS complex feature'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011008', 'cui_str': 'Date'}]",,0.205921,Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V).,"[{'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Junmeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zefeng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mengge', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, Beijing Anzhen Hospital, Capital Medical University, the Key Laboratory of Remodeling-Related Cardiovascular Diseases, Ministry of Education, Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jieruo', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China wuyongquan67@163.com.'}]",BMJ open,['10.1136/bmjopen-2020-036972']
2869,32973113,Staged angioplasty versus regular carotid artery stenting in patients with carotid artery stenosis at high risk of hyperperfusion: a randomised clinical trial.,"BACKGROUND AND PURPOSE


Hyperperfusion (HP) is a devastating complication associated with carotid artery stenting (CAS) or endarterectomy. The efficacy and safety of staged angioplasty (SAP) in patients with CAS at high risk of HP remains unclear. We sought to determine whether SAP is superior to regular CAS in patients with high risk of HP.
METHODS


A randomised, multicentre open-label clinical trial with blinded outcome assessment (STEP) was conducted. Patients with severe carotid stenosis at high risk of HP were randomly assigned (1:1) to the SAP or regular CAS group. The primary endpoint was hyperperfusion syndrome (HPS) and intracerebral haemorrhage (ICH) within 30 days after the procedure.
RESULTS


From November 2014 to January 2017, a total of 64 patients were enrolled in 11 centres. 33 patients were allocated to the SAP group and 31 to the regular CAS group. At 30 days, the rate of primary endpoint was 0.0% (0/33) in the SAP group and 9.7% (3/31) in the regular CAS group (absolute risk reduction (ARR), 9.7%; 95% CI -20.1% to 0.7%; p=0.11). As one of the secondary endpoints, the incidence of HP phenomenon (HPP) was lower in the SAP group than the regular CAS group (0.0% vs 22.6%, ARR,-22.6%; 95% CI -36.8% to -10.2%; p=0.04).
CONCLUSION


The rate of HPS and ICH was not significantly lower in SAP group; the extended secondary endpoint of HPP, however, significantly reduced, which suggested that SAP may be a safe and effective carotid revascularisation procedure to prevent HP.
TRIAL REGISTRATION NUMBER


NCT02224209.",2020,"The rate of HPS and ICH was not significantly lower in SAP group; the extended secondary endpoint of HPP, however, significantly reduced, which suggested that SAP may be a safe and effective carotid revascularisation procedure to prevent HP.
","['Patients with severe carotid stenosis at high risk of HP', 'From November 2014 to January 2017, a total of 64 patients were enrolled in 11 centres', 'patients with carotid artery stenosis at high risk of hyperperfusion', '33 patients', 'patients with CAS at high risk of HP remains unclear', 'patients with high risk of HP']","['staged angioplasty (SAP', 'SAP', 'SAP or regular CAS', 'carotid artery stenting (CAS) or endarterectomy', 'Staged angioplasty versus regular carotid artery stenting']","['hyperperfusion syndrome (HPS) and intracerebral haemorrhage (ICH', 'rate of HPS and ICH', 'efficacy and safety', 'incidence of HP phenomenon (HPP', 'rate of primary endpoint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0850458', 'cui_str': 'Carotid stent'}]","[{'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0850458', 'cui_str': 'Carotid stent'}, {'cui': 'C0014098', 'cui_str': 'Endarterectomy'}]","[{'cui': 'C1611713', 'cui_str': 'Cerebral hyperperfusion syndrome'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520739', 'cui_str': 'Hereditary pyropoikilocytosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",64.0,0.230252,"The rate of HPS and ICH was not significantly lower in SAP group; the extended secondary endpoint of HPP, however, significantly reduced, which suggested that SAP may be a safe and effective carotid revascularisation procedure to prevent HP.
","[{'ForeName': 'Dapeng', 'Initials': 'D', 'LastName': 'Mo', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Baixue', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Huaizhang', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Yaxuan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Neurology, Shaanxi Provincial People's Hospital, Xi'an, China.""}, {'ForeName': 'Qingan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Neurosurgery, Harbin Medical University Fourth Hospital, Harbin, China.'}, {'ForeName': 'Chengzhe', 'Initials': 'C', 'LastName': 'Fan', 'Affiliation': 'Neurology, Beijing An Zhen Hospital, Beijing, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Deng', 'Affiliation': ""Neurosurgery, Tangdu Hospital, The Second Affiliated Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jinglin', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Neurology, Daxing Teaching Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Neurology, Shandong University Qilu Hospital, Jinan, China.'}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Neurology, Baotou Central Hospital, Baotou, China.'}, {'ForeName': 'Guilian', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': ""Neurology, Xi'an Jiaotong University Second Affiliated Hospital, Xi'an, China.""}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Neurology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ma', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Guangge', 'Initials': 'G', 'LastName': 'Peng', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Beijing, China.'}, {'ForeName': 'Zhongrong', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Interventional Neuroradiology, Beijing Tiantan Hospital, Beijing, China doctorzhongrongm@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke and vascular neurology,['10.1136/svn-2020-000391']
2870,32968947,"Placebo-Controlled, Double-Blind Study of Empagliflozin (EMPA) and Implantable Cardioverter-Defibrillator (EMPA-ICD) in Patients with Type 2 Diabetes (T2DM): Rationale and Design.","INTRODUCTION


Type 2 diabetes (T2DM) is associated with cardiovascular death, including sudden cardiac death due to arrhythmias. Patients with an implantable cardioverter-defibrillator (ICD) are also at high risk of developing a clinically significant ventricular arrhythmia. It has been reported that sodium-glucose cotransporter 2 (SGLT2) inhibitors can reduce cardiovascular deaths; however, the physiological mechanisms of this remain unclear. It is, however, well known that SGLT2 inhibitors increase blood ketone bodies, which have been suggested to have sympatho-suppressive effects. Empagliflozin (EMPA) is an SGLT2 inhibitor. The current clinical trial titled ""Placebo-controlled, double-blind study of empagliflozin (EMPA) and implantable cardioverter-defibrillator (EMPA-ICD) in patients with type 2 diabetes (T2DM)"" was designed to investigate the antiarrhythmic effects of EMPA.
METHODS


The EMPA-ICD study is a prospective, multicenter, placebo-controlled, double-blind, randomized, investigator-initiated clinical trial currently in progress. A total of 210 patients with T2DM (hemoglobin A1c 6.5-10.0%) will be randomized (1:1) to receive once-daily placebo or EMPA, 10 mg, for 24 weeks. The primary endpoint is the number of clinically significant ventricular arrhythmias for 24 weeks before and 24 weeks after study drug administration, as documented by the ICD. The secondary endpoints of the study are the change from baseline concentrations in blood ketone and catecholamine 24 weeks after drug treatment.
CONCLUSION


The EMPA-ICD study is the first clinical trial to assess the effect of an SGLT2 inhibitor on clinically significant ventricular arrhythmias in patients with T2DM and an ICD.
TRIAL REGISTRATION


Unique trial number, jRCTs031180120 ( https://jrct.niph.go.jp/latest-detail/jRCTs031180120 ).",2020,"The primary endpoint is the number of clinically significant ventricular arrhythmias for 24 weeks before and 24 weeks after study drug administration, as documented by the ICD.","['Patients with Type\xa02 Diabetes (T2DM', 'patients with type\xa02 diabetes (T2DM', '210 patients with T2DM (hemoglobin', 'patients with T2DM and an ICD']","['placebo or EMPA', 'empagliflozin (EMPA) and implantable cardioverter-defibrillator (EMPA-ICD', 'Empagliflozin (EMPA', 'Implantable Cardioverter-Defibrillator (EMPA-ICD', 'placebo', 'implantable cardioverter-defibrillator (ICD', 'Placebo', 'SGLT2 inhibitor']","['number of clinically significant ventricular arrhythmias', 'cardiovascular deaths', 'blood ketone and catecholamine 24\xa0weeks after drug treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",210.0,0.405225,"The primary endpoint is the number of clinically significant ventricular arrhythmias for 24 weeks before and 24 weeks after study drug administration, as documented by the ICD.","[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Fujiki', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Iijima', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Okabe', 'Affiliation': 'Department of Cardiology, Tachikawa General Hospital, Nagaoka, Niigata, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Niwano', 'Affiliation': 'Cardiovascular Medicine, Kitasato University, Sagamihara, Kanagawa, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Tsujita', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Naito', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, Maebashi, Gunma, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kusano', 'Affiliation': 'Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan.'}, {'ForeName': 'Ritsushi', 'Initials': 'R', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Nitta', 'Affiliation': 'Department of Cardiology, Sakakibara Heart Institute, Fuchu, Tokyo, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Miura', 'Affiliation': 'Department of Cardiovascular, Renal and Metabolic Medicine, Sapporo Medical University School of Medicine, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Mitsuhashi', 'Affiliation': 'Department of Cardiology, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Ieda', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Niigata City General Hospital, Niigata, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomita', 'Affiliation': 'Department of Cardiology and Nephrology, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan.'}, {'ForeName': 'Yasuchika', 'Initials': 'Y', 'LastName': 'Takeishi', 'Affiliation': 'Department of Cardiovascular Medicine, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Toshihisa', 'Initials': 'T', 'LastName': 'Anzai', 'Affiliation': 'Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiology, Pulmonology, and Nephrology, Yamagata University Faculty of Medicine, Yamagata, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Iwate Medical University, Morioka, Iwate, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Cardiology, Graduate School of Medical Science, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Shiga, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Maemura', 'Affiliation': 'Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Yoshida', 'Affiliation': 'Department of Medial Statistics, Osaka City University, Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ota', 'Affiliation': 'Data Management Group, Department of Clinical Research Support, Center for Clinical Research and Innovation, Osaka City University Hospital, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Kitamura', 'Affiliation': 'Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Yoshifusa', 'Initials': 'Y', 'LastName': 'Aizawa', 'Affiliation': 'Department of Cardiology, Tachikawa General Hospital, Nagaoka, Niigata, Japan.'}, {'ForeName': 'Ippei', 'Initials': 'I', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Izumi', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Ozaki', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Minamino', 'Affiliation': 'Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. t.minamino@juntendo.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00924-9']
2871,32968968,"See One, Do One, Forget One: Early Skill Decay After Paracentesis Training.","INTRODUCTION


Internal medicine residents perform paracentesis, but programs lack standard methods for assessing competence or maintenance of competence and instead rely on number of procedures completed. This study describes differences in resident competence in paracentesis over time.
METHODS


From 2016 to 2017, internal medicine residents (n = 118) underwent paracentesis simulation training. Competence was assessed using the Paracentesis Competency Assessment Tool (PCAT), which combines a checklist, global scale, and entrustment score. The PCAT also delineates two categorical cut-point scores: the Minimum Passing Standard (MPS) and the Unsupervised Practice Standard (UPS). Residents were randomized to return to the simulation lab at 3 and 6 months (group A, n = 60) or only 6 months (group B, n = 58). At each session, faculty raters assessed resident performance. Data were analyzed to compare resident performance at each session compared with initial training scores, and performance between groups at 6 months.
RESULTS


After initial training, all residents met the MPS. The number achieving UPS did not differ between groups: group A = 24 (40%), group B = 20 (34.5%), p = 0.67. When group A was retested at 3 months, performance on each PCAT component significantly declined, as did the proportion of residents meeting the MPS and UPS. At the 6-month test, residents in group A performed significantly better than residents in group B, with 52 (89.7%) and 20 (34.5%) achieving the MPS and UPS, respectively, in group A compared with 25 (46.3%) and 2 (3.70%) in group B (p < .001 for both comparison).
DISCUSSION


Skill in paracentesis declines as early as 3 months after training. However, retraining may help interrupt skill decay. Only a small proportion of residents met the UPS 6 months after training. This suggests using the PCAT to objectively measure competence would reclassify residents from being permitted to perform paracentesis independently to needing further supervision.",2020,This suggests using the PCAT to objectively measure competence would reclassify residents from being permitted to perform paracentesis independently to needing further supervision.,"['From 2016 to 2017, internal medicine residents (n\u2009=\u2009118) underwent']","['paracentesis simulation training', 'PCAT']",['number achieving UPS'],"[{'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",,0.0174027,This suggests using the PCAT to objectively measure competence would reclassify residents from being permitted to perform paracentesis independently to needing further supervision.,"[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Sall', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA. dana.sall@gmail.com.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Warm', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Kinnear', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kelleher', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Jandarov', 'Affiliation': 'Department of Environmental Health, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06242-x']
2872,32968994,[CARD study: relevance for the treatment of advanced prostate cancer].,"BACKGROUND


Various life-prolonging therapy options are available for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
OBJECTIVE


The optimal therapy sequence for mCRPC has been discussed for years. With the final results of the CARD study, important prospective data are available to enlighten the discussion about the therapy sequence.
MATERIAL AND METHOD


CARD is a randomised phase IV trial in patients with mCRPC who were previously treated with docetaxel and an anti-androgen receptor (ARTA). The study showed significant efficacy benefits in favour of further treatment with cabazitaxel versus a second ARTA therapy. The study results are presented and discussed in the context of previous study data with regard to their importance for everyday clinical practice.
RESULTS


The CARD study data confirm cabazitaxel as an effective therapy option for mCRPC patients previously treated with docetaxel and an ARTA. Cabazitaxel was safe to apply. The study results confirm the cross resistance between the two ARTAs Abiraterone and Enzalutamide.
CONCLUSION


In mCRPC patients eligible for chemotherapy, the therapy sequence should be chosen so that the patients also receive cabazitaxel. A direct therapy sequence with two ARTAs should be avoided or, at least, only considered if other substances are contraindicated.",2020,Cabazitaxel was safe to apply.,"['advanced prostate cancer', 'mCRPC patients previously treated with', 'metastatic castration-resistant prostate cancer (mCRPC', 'patients with mCRPC who were previously treated with']","['docetaxel', 'docetaxel and an anti-androgen receptor (ARTA', 'cabazitaxel']",[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002842', 'cui_str': 'Antiandrogen'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}]",[],,0.0116076,Cabazitaxel was safe to apply.,"[{'ForeName': 'Axel S', 'Initials': 'AS', 'LastName': 'Merseburger', 'Affiliation': 'Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Urology, Lübeck.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bannowsky', 'Affiliation': 'imland Klinik Rendsburg, Urologie, Rendsburg.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Becker', 'Affiliation': 'Onkologie Lerchenfeld, Onkologie Lerchenfeld, Hamburg.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Universitätsklinikum Hamburg Eppendorf Medizinische Klinik und Poliklinik II Onkologie Hämatologie, Zentrum für Onkologie, Hamburg.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Eichenauer', 'Affiliation': 'Urologikum MVZ, Urologikum MVZ, Hamburg.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lehmann', 'Affiliation': 'Gesundheitszentrum Kiel-Mitte, Urologische Gemeinschaftspraxis Prüner Gang, Kiel.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Mickisch', 'Affiliation': 'Centrum für Operative Urologie Bremen, Centrum für Operative Urologie Bremen, Bremen.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Steuber', 'Affiliation': 'Universitätsklinikum Hamburg-Eppendorf, Martini-Klinik, Prostatakrebszentrum, Hamburg.'}, {'ForeName': 'Gunhild', 'Initials': 'G', 'LastName': 'von Amsberg', 'Affiliation': 'Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum, Hamburg.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'von Kügelgen', 'Affiliation': 'Urologisch-proktologische Gemeinschaftspraxis, Gruppenpraxis Rosen, Wedel.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wülfing', 'Affiliation': 'Asklepios Klinik Altona, Urologie, Hamburg.'}]",Aktuelle Urologie,['10.1055/a-1247-4155']
2873,32969007,US Army Combat Medic Performance With Portable Ultrasound to Detect Sonographic Findings of Pneumothorax in a Cadaveric Model.,"BACKGROUND


Ultrasound, due to recent advances in portability and versatility, has become a valuable clinical adjunct in austere, resource-limited settings and is well demonstrated to be an accurate/efficient means to detect pneumothorax. The purpose of this study was to evaluate the impact of hands-on ultrasound training on ultrasound-naive US Army combat medics' ability to detect sonographic findings of pneumothorax with portable ultrasound in a cadaver model.
METHODS


Ultrasound-naive US Army combat medics assigned to conventional military units were recruited from a single US Army installation and randomized to receive either didactic training only, or ""blended"" (didactic and hands-on) training on ultrasound detection of pneumothorax. Blinded participants were asked to perform a thoracic ultrasound exam on ventilated human cadaver models. Primary outcome measured was sensitivity and specificity of detecting sonographic findings of pneumothorax between cohorts.
RESULTS


Forty-three participants examined a total of 258 hemithoraces. The didactic-only cohort (n = 24) detected sonographic findings of pneumothorax with a sensitivity of 68% and specificity of 57%. The blended cohort (n = 19) detected sonographic findings of pneumothorax with an overall sensitivity of 91% and specificity of 80%. Detection sensitivities were similar between B-mode versus M-mode use.
CONCLUSION


US Army combat medics can use portable U/S to detect sonographic findings of pneumothorax in a human cadaver model with high sensitivity after a brief, blended (didactic and hands-on) training intervention.",2020,The didactic-only cohort (n = 24) detected sonographic findings of pneumothorax with a sensitivity of 68% and specificity of 57%.,"['Ultrasound-naive US Army combat medics assigned to conventional military units were recruited from a single US Army installation', 'Forty-three participants examined a total of 258 hemithoraces']","['didactic training only, or ""blended"" (didactic and hands-on) training on ultrasound detection of pneumothorax', 'thoracic ultrasound exam on ventilated human cadaver models', 'ultrasound training']","['sonographic findings of pneumothorax', 'Detection sensitivities', 'sensitivity and specificity of detecting sonographic findings of pneumothorax between cohorts']","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0030450', 'cui_str': 'Paramedical Personnel'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",258.0,0.0238824,The didactic-only cohort (n = 24) detected sonographic findings of pneumothorax with a sensitivity of 68% and specificity of 57%.,"[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Meadows', 'Affiliation': ''}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Monti', 'Affiliation': ''}, {'ForeName': 'Mohamad A', 'Initials': 'MA', 'LastName': 'Umar', 'Affiliation': ''}, {'ForeName': 'Kerri A', 'Initials': 'KA', 'LastName': 'Van Arnem', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Chin', 'Affiliation': ''}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Mitchell', 'Affiliation': ''}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Love', 'Affiliation': ''}]",Journal of special operations medicine : a peer reviewed journal for SOF medical professionals,[]
2874,32969022,Cannabidiol in conjunction with clobazam: analysis of four randomized-controlled trials.,"OBJECTIVES


To assess the efficacy and safety profile of add-on cannabidiol (CBD) in patients with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) on clobazam and in the overall population of four randomized, controlled phase 3 trials.
METHODS


Patients received plant-derived, highly purified CBD medicine (Epidiolex ®  in US; Epidyolex ®  in Europe; 100 mg/mL oral solution) at a dose of 10 or 20 mg/kg/day, or placebo for 14 weeks. A subgroup analysis of patients on clobazam and meta-analysis by syndrome were conducted. The primary endpoint was percentage reduction in primary seizure type during the treatment period.
RESULTS


396 patients with LGS (49% on clobazam) and 318 patients with DS (64% on clobazam) were included. CBD treatment resulted in a reduction in primary seizure frequency vs placebo in the overall population (treatment ratio [95% confidence interval]: LGS, 0.70 [0.62-0.80]; DS, 0.71 [0.60-0.83]) and in patients receiving clobazam (LGS, 0.56 [0.47-0.67]; DS, 0.63 [0.52-0.77]). The antiseizure efficacy of CBD was also demonstrated across other endpoints vs placebo (≥50% responder rate, total seizure frequency, number of seizure-free days, and Subject/Caregiver Global Impression of Change scores) in the overall populations and in patients receiving clobazam. There were higher incidences of somnolence and sedation in patients on CBD and clobazam. Most incidences of elevated transaminases occurred in patients on concomitant valproate and, to a lesser extent, clobazam.
CONCLUSIONS


Add-on CBD was effective in reducing seizures in the overall populations and in conjunction with clobazam. Somnolence and sedation occurred more frequently in patients on CBD and clobazam.",2020,CBD treatment resulted in a reduction in primary seizure frequency vs placebo in the overall population (treatment ratio [95% confidence interval]:,"['396 patients with LGS (49% on', 'patients with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) on', '318 patients with DS (64% on', 'Patients received']","['CBD', 'plant-derived, highly purified CBD medicine (Epidiolex ®  in US; Epidyolex ®  in Europe; 100\xa0mg/mL oral solution', 'cannabidiol (CBD', 'placebo', 'clobazam']","['elevated transaminases', 'primary seizure frequency', 'somnolence and sedation', 'percentage reduction in primary seizure type', 'total seizure frequency, number of seizure-free days, and Subject/Caregiver Global Impression of Change scores', 'antiseizure efficacy of CBD', 'Somnolence and sedation']","[{'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238111', 'cui_str': 'Lennox-Gastaut syndrome'}, {'cui': 'C0751122', 'cui_str': 'Severe myoclonic epilepsy in infancy'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4731581', 'cui_str': 'Epidiolex'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0991536', 'cui_str': 'Oral solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0055891', 'cui_str': 'clobazam'}]","[{'cui': 'C0438717', 'cui_str': 'Transaminases increased'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}]",396.0,0.31064,CBD treatment resulted in a reduction in primary seizure frequency vs placebo in the overall population (treatment ratio [95% confidence interval]:,"[{'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Gunning', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland, Zwolle, The Netherlands.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Mazurkiewicz-Beldzinska', 'Affiliation': 'Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Richard F M', 'Initials': 'RFM', 'LastName': 'Chin', 'Affiliation': 'Royal Hospital for Sick Children, Edinburgh, UK.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Bhathal', 'Affiliation': 'Centro Médico Teknon, Neurocenter Barcelona, Barcelona, Spain.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Nortvedt', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Greenwich Biosciences, Inc, Carlsbad, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Checketts', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}]",Acta neurologica Scandinavica,['10.1111/ane.13351']
2875,32969391,Comparison of Outcomes Between Mometasone Furoate Intranasal Spray and Oral Montelukast in Patients with Allergic Rhinitis.,"BACKGROUND


Allergic rhinitis is a common ailment with rising trend and worldwide prevalence of some 400 million.
METHODS


This prospective randomized crosssectional study was done at the Department of Otorhinolaryngology and Head and Neck Surgery, Tribhuvan University, Teaching Hospital, Kathmandu, Nepal from June 2016 to August 2017. They were randomly assigned to two groups by lottery method. Group A received mometasone furoate intranasal spray and Group B received oral montelukast for a total duration of one month. Prior to starting medication and one month after medications, total nasal symptom score was documented. Statistical analysis was done using SPSS version 18.
RESULTS


Total of 126 patients between 16 to 52 years were enrolled in the study. The mean duration of symptoms was 3.93 years. The mean value of serum total IgE was 833.49 IU/ml. The mean pre and post medication score for mometasone furoate intranasal spray group was 16.32 and 5.44 respectively, which was significant. Similarly, the mean pre and post medication score for oral montelukast group was 15.24 and 7.87 respectively which was also found to be significant. Comparing the means of scores for both the groups, mometasone furoate was found to be more effective than oral montelukast.
CONCLUSIONS


Both mometasone furoate intranasal spray and oral montelukast were effective in the treatment of patient with allergic rhinitis. Oral montelukast can therefore be used as a first line treatment for patients with allergic rhinitis.",2020,"Comparing the means of scores for both the groups, mometasone furoate was found to be more effective than oral montelukast.
","['patient with allergic rhinitis', 'Patients with Allergic Rhinitis', 'patients with allergic rhinitis', 'Total of 126 patients between 16 to 52 years were enrolled in the study', 'Department of Otorhinolaryngology and Head and Neck Surgery, Tribhuvan University, Teaching Hospital, Kathmandu, Nepal from June 2016 to August 2017']","['mometasone furoate intranasal spray and Group B received oral montelukast', 'mometasone furoate', 'mometasone furoate intranasal spray', 'Mometasone Furoate Intranasal Spray and Oral Montelukast', 'mometasone furoate intranasal spray and oral montelukast', 'Oral montelukast']","['mean pre and post medication score', 'total nasal symptom score', 'mean duration of symptoms', 'mean value of serum total IgE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029892', 'cui_str': 'Otolaryngology'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]","[{'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}]",126.0,0.0251199,"Comparing the means of scores for both the groups, mometasone furoate was found to be more effective than oral montelukast.
","[{'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhattachan', 'Affiliation': 'Department of ENT- Head and Neck Surgery, Tribhuvan University Teaching Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Yogesh', 'Initials': 'Y', 'LastName': 'Neupane', 'Affiliation': 'Department of ENT- Head and Neck Surgery, Tribhuvan University Teaching Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Bibhu', 'Initials': 'B', 'LastName': 'Pradhan', 'Affiliation': 'Department of ENT- Head and Neck Surgery, Tribhuvan University Teaching Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Naramaya', 'Initials': 'N', 'LastName': 'Thapa', 'Affiliation': 'Department of ENT- Head and Neck Surgery, Tribhuvan University Teaching Hospital, Kathmandu, Nepal.'}]",Journal of Nepal Health Research Council,['10.33314/jnhrc.v18i2.2509']
2876,31815509,"Patient motivational language in the prediction of symptom change, clinically significant response, and time to response in psychotherapy for generalized anxiety disorder.","Existing research demonstrates that patient change-talk (CT), or self-arguments for change, associates variably with favorable outcomes, whereas counter change-talk (CCT), or self-arguments against change, associates consistently with poorer outcomes. However, most studies on change language have focused on posttreatment versus more proximal outcomes. Addressing this gap, we examined Session 1 CT and CCT as predictors of during-treatment worry change, likelihood of clinically significant response during treatment, and time to response across cognitive-behavioral therapy (CBT;  n  = 43) and CBT integrated with motivational interviewing (MI;  n  = 42) for generalized anxiety disorder. We also explored whether treatment moderated these associations. Multilevel modeling revealed that, across both treatments, more CT associated with lower midtreatment worry level ( p  = .04), whereas more CCT associated with lower worry level ( p  = .048) and a slower rate of worry reduction at midtreatment ( p  = .04). Treatment moderated only the associations between CT and both midtreatment worry level ( p  = .03) and rate of change ( p  = .03). CBT patients with higher versus lower CT had lower worry and a faster rate of worry reduction; in MI-CBT, CT was unrelated to these outcomes. Survival analyses revealed that, across both treatments, more CT associated with a greater likelihood of response ( p  = .004) and approached a faster time to response ( p  = .05), and more CCT associated with a lower likelihood of response ( p  = .001) and approached a slower time to response ( p  = .06). Motivational language predicts proximal outcomes and may be useful in treatment selection. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Multilevel modeling revealed that, across both treatments, more CT associated with lower midtreatment worry level ( p  = .04), whereas more CCT associated with lower worry level ( p  = .048) and a slower rate of worry reduction at midtreatment ( p  = .04).",[],"['CBT', 'CBT integrated with motivational interviewing (MI;  n  = 42']","['generalized anxiety disorder', 'rate of worry reduction', 'rate of change', 'slower rate of worry reduction']",[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439834', 'cui_str': 'Slow'}]",,0.018171,"Multilevel modeling revealed that, across both treatments, more CT associated with lower midtreatment worry level ( p  = .04), whereas more CCT associated with lower worry level ( p  = .048) and a slower rate of worry reduction at midtreatment ( p  = .04).","[{'ForeName': 'Brien J', 'Initials': 'BJ', 'LastName': 'Goodwin', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts Amherst.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Constantino', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Massachusetts Amherst.'}, {'ForeName': 'Henny A', 'Initials': 'HA', 'LastName': 'Westra', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Button', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'Department of Psychology, Ryerson University.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000269']
2877,32869847,First Trimester DEX Treatment Is Not Associated with Altered Brain Activity During Working Memory Performance in Adults.,"CONTEXT


Prenatal dexamethasone (DEX) treatment is sometimes used in pregnancies at risk for congenital adrenal hyperplasia (CAH) to prevent virilization in female fetuses with CAH. In boys and in fetuses not having CAH, there is no benefit of early DEX treatment and the risks of this therapy must be thoroughly investigated. High doses of prenatal glucocorticoid might alter the developmental trajectory of the brain into adulthood, even for CAH unaffected subjects treated with DEX for a short term during the first trimester.
OBJECTIVE


The present study investigated brain activation during working memory performance in DEX-treated subjects compared with controls.
DESIGN, SETTING, AND PARTICIPANTS


We tested 18 participants who were exposed to DEX during the first trimester of fetal life but did not have CAH (8 females; mean age 20.78 [standard deviation (SD), 2.67] years) and 40 control participants (24 females; mean age 20.53 [SD, 2.64]) from a single research institute. Participants underwent functional magnetic resonance imaging on a 3T scanner during a verbal and visuospatial working memory task.
RESULTS


We did not observe any differences in brain activity during working memory performance. However, DEX-treated subjects responded faster during the experimental condition of the verbal WM task.
CONCLUSIONS


First trimester DEX treatment did not seem to result in altered working memory-related brain activity at adult age. Our findings contribute to the risk-benefit assessment of prenatal DEX treatment in the context of CAH.",2020,We did not observe any differences in brain activity during working memory performance.,"['Adults', 'female fetuses with CAH', 'We tested 18 participants who were exposed to DEX during the first trimester of fetal life but did not have CAH (8 females; mean age 20.78 [standard deviation (SD), 2.67] years) and 40 control participants (24 females; mean age 20.53 [SD, 2.64]) from a single research institute']","['DEX', 'prenatal glucocorticoid', 'dexamethasone', 'functional magnetic resonance imaging', 'DEX-treated subjects compared with controls']","['Altered Brain Activity', 'altered working memory-related brain activity', 'brain activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0001627', 'cui_str': 'Congenital adrenal hyperplasia'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035172', 'cui_str': 'Research Institutes'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",18.0,0.0396656,We did not observe any differences in brain activity during working memory performance.,"[{'ForeName': 'Annelies', 'Initials': 'A', 'LastName': ""Van't Westeinde"", 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Pediatric Endocrinology Unit (QB83), Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Zimmermann', 'Affiliation': 'Section for Cognitive Systems, DTU Compute, Technical University of Denmark Lyngby, Denmark.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Messina', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Pediatric Endocrinology Unit (QB83), Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Karlsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Pediatric Endocrinology Unit (QB83), Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Padilla', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Department of Neonatology Norrbacka, Karolinska vägen, Sweden.""}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Lajic', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Pediatric Endocrinology Unit (QB83), Karolinska University Hospital, Stockholm, Sweden.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa611']
2878,30967869,A Rare Genetic Defect of  MBL2  Increased the Risk for Progression of IgA Nephropathy.,"The aim of this study was to investigate the association between lectin pathway-related genetic variations and progression in IgA nephropathy. Biopsy-proven IgAN patients with eGFR ≥15 ml/min/1.73 m 2  at baseline and a minimum follow-up of 12-months were enrolled. A total of 1,007 patients and 121 healthy controls were enrolled from two Chinese renal centers. The discovery cohort consisted of 606 patients, and the validation cohort consisted of 401 patients. First, promoters, all exons and their boundary regions of  MBL2  and  FCN2  were sequenced in 50 patients, and then 37 variations were identified. Of these variations, 7 expression-associated variations were selected and genotyped in the whole discovery cohort. We found that rs1800450 in  MBL2  and rs7851696 in  FCN2  were associated with an increased risk for ESRD as well as serum MBL or L-ficolin levels. However, only rs1800450 was successively validated for its association with ESRD (HR, 15.91; 3.27-77.34;  P  = 0.001) in the fully adjusted model in the validation cohort. In addition, 2.7% of patients, and 2.5% of healthy controls carried rs1800450-AA. IgAN patients with rs1800450-AA lacked expression of MBL in both serum and renal tissue and had more severe tubulointerstitial damage. Furthermore, a combined effect of rs1800450-AA with a previously reported clinical risk score was observed in which patients with both a high clinical risk score (≥1%) and rs1800450-AA had a strikingly increased 10-years ESRD risk by 37.1-fold (7.17 to 192.13-fold). In summary, IgAN patients carrying  MBL2  rs1800450-AA have a high risk for renal function deterioration, probably due to inactivation of the complement MBL pathway.",2019,IgAN patients with rs1800450-AA lacked expression of MBL in both serum and renal tissue and had more severe tubulointerstitial damage.,"['Biopsy-proven IgAN patients with eGFR ≥15 ml/min/1.73 m 2  at baseline and a minimum follow-up of 12-months were enrolled', '1,007 patients and 121 healthy controls were enrolled from two Chinese renal centers', '606 patients, and the validation cohort consisted of 401 patients', 'IgA nephropathy']",[],"['severe tubulointerstitial damage', 'clinical risk score', '10-years ESRD risk', 'serum MBL or L-ficolin levels']","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0753748', 'cui_str': 'L-ficolin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1007.0,0.0202103,IgAN patients with rs1800450-AA lacked expression of MBL in both serum and renal tissue and had more severe tubulointerstitial damage.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ouyang', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Manman', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shuwen', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yuanmeng', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jingyuan', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Frontiers in immunology,['10.3389/fimmu.2019.00537']
2879,31222796,Simultaneous phenotyping of CYP2E1 and CYP3A using oral chlorzoxazone and midazolam microdoses.,"AIMS


Chlorzoxazone is the paradigm marker substrate for CYP2E1 phenotyping in vivo. Because at the commonly used milligram doses (250-750 mg) chlorzoxazone acts as an inhibitor of the CYP3A4/5 marker substrate midazolam, previous attempts failed to combine both drugs in a common phenotyping cocktail. Microdosing chlorzoxazone could circumvent this problem.
METHOD


We enrolled 12 healthy volunteers in a trial investigating the dose-exposure relationship of single ascending chlorzoxazone oral doses over a 10,000-fold range (0.05-500 mg) and assessed the effect of 0.1 and 500 mg of chlorzoxazone on oral midazolam pharmacokinetics (0.003 mg).
RESULTS


Chlorzoxazone area under the concentration-time curve was dose-linear in the dose range between 0.05 and 5 mg. A nonlinear increase occurred with doses ≥50 mg, probably due to saturated presystemic metabolic elimination. While midazolam area under the concentration-time curve increased 2-fold when coadministered with 500 mg of chlorzoxazone, there was no pharmacokinetic interaction between chlorzoxazone and midazolam microdoses.
CONCLUSION


The chlorzoxazone microdose did not interact with the CYP3A marker substrate midazolam, enabling the simultaneous administration in a phenotyping cocktail. This microdose assay is now ready to be further validated and tested as a phenotyping procedure assessing the impact of induction and inhibition of CYP2E1 on chlorzoxazone microdose pharmacokinetics.",2019,"We enrolled 12 healthy volunteers in a trial investigating the dose-exposure relationship of single ascending chlorzoxazone oral doses over a 10,000-fold range (0.05-500 mg) and assessed the effect of 0.1 and 500 mg of chlorzoxazone on oral midazolam pharmacokinetics (0.003 mg).
",['12 healthy volunteers'],"['chlorzoxazone', 'Chlorzoxazone', 'chlorzoxazone on oral midazolam pharmacokinetics', 'CYP3A marker substrate midazolam', 'midazolam']","['concentration-time curve', 'pharmacokinetic interaction']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0008296', 'cui_str': 'Chlorzoxazone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1868980', 'cui_str': 'Pharmacokinetic interaction'}]",12.0,0.0501719,"We enrolled 12 healthy volunteers in a trial investigating the dose-exposure relationship of single ascending chlorzoxazone oral doses over a 10,000-fold range (0.05-500 mg) and assessed the effect of 0.1 and 500 mg of chlorzoxazone on oral midazolam pharmacokinetics (0.003 mg).
","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Hohmann', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Blank', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Burhenne', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Mikus', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Walter E', 'Initials': 'WE', 'LastName': 'Haefeli', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacoepidemiology, University Hospital Heidelberg, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14040']
2880,32974881,"Evaluation of the ECOHIS and the CARIES-QC among an Australian ""Aboriginal"" population.","PURPOSE


An evaluation of the reliability and validity of two child oral health-related quality of life (COHRQoL) measures among Australian Aboriginal children who participated in a randomised trial was undertaken.
METHODS


Study participants completed the Early Childhood Oral Health Impact Scale (ECOHIS) and the Caries Impacts and Experiences Questionnaire for Children (CARIES-QC). The questionnaires were completed a second time to test the scales' test-retest reliability. Internal consistency, convergent and discriminant validity were evaluated through Cronbach's alpha, correlation of the scale scores with the global oral health evaluation, and comparison of scale scores among children with varying levels of caries experience, respectively.
RESULTS


Worse COHRQoL was reported by parents who rated their child's oral health as poor and by children who rated their teeth as being a lot of problem. Cronbach's alpha for the child impact section (CIS), family impact section (FIS), total ECOHIS score and the total CARIES-QC scale were 0.88, 0.81, 0.91 and 0.84, respectively. Spearman's correlations between scale scores and global oral health ratings of the CIS, FIS, total ECOHIS and the CARIES-QC were 0.42, 0.34, 0.45 and 0.70, respectively, p < 0.001. The Kruskal-Wallis test of scale scores with grouped caries experience was statistically significant, p < 0.005. Test-retest reliabilities for the ECOHIS were CIS ICC = 0.91, FIS ICC = 0.89, total ECOHIS ICC = 0.93 and for the CARIES-QC, ICC = 0.61.
CONCLUSIONS


Both the ECOHIS and the CARIES-QC were reliable and valid scales for use among an Australian Aboriginal population for assessing COHRQoL of preschool children.
TRIAL REGISTRATION


ACTRN12616001537448, date of registration-08 November 2016.",2020,"Both the ECOHIS and the CARIES-QC were reliable and valid scales for use among an Australian Aboriginal population for assessing COHRQoL of preschool children.
",['Australian Aboriginal children who participated in a randomised trial was undertaken'],[],"['child impact section (CIS), family impact section (FIS), total ECOHIS score and the total CARIES-QC scale', 'quality of life (COHRQoL) measures', 'Early Childhood Oral Health Impact Scale (ECOHIS) and the Caries Impacts and Experiences Questionnaire for Children (CARIES-QC', 'scale scores and global oral health ratings of the CIS, FIS, total ECOHIS and the CARIES-QC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0543899,"Both the ECOHIS and the CARIES-QC were reliable and valid scales for use among an Australian Aboriginal population for assessing COHRQoL of preschool children.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Arrow', 'Affiliation': 'Western Australia Dental Health Services, Research and Evaluation, Health Department of Western Australia, Perth, Australia. parrow@ozemail.com.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brennan', 'Affiliation': 'Australian Research Centre for Population Oral Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Mackean', 'Affiliation': 'Southgate Institute for Health, Society and Equity, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'McPhee', 'Affiliation': 'Kimberley Aboriginal Medical Services, Broome, Australia.'}, {'ForeName': 'Sanjeewa', 'Initials': 'S', 'LastName': 'Kularatna', 'Affiliation': 'Australian Centre for Health Services Innovation, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jamieson', 'Affiliation': 'Australian Research Centre for Population Oral Health, University of Adelaide, Adelaide, Australia.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02646-8']
2881,32974894,Transient stent placement versus tubeless procedure after ureteroscopy retrograde surgery stone extraction (Fast Track Stent study 2): A randomized prospective evaluation.,"OBJECTIVES


To determine whether in pre-stented patients undergoing ureteroscopic stone removal (ureteroscopy retrograde surgery) a tubeless procedure provides a better outcome compared with short-term (6 h) ureteral stenting using an external ureteral catheter.
METHODS


In this single academic center study (Fast Track Stent study 2), carried out between May 2016 and April 2018, 121 patients with renal or ureteral calculi were initially treated with double-J insertion. Before secondary ureteroscopy retrograde surgery, patients were prospectively randomized into two groups: tubeless versus ureteral catheter insertion for 6 h after ureteroscopy retrograde surgery. Exclusion criteria were acute urinary tract infection, solitary kidney or stone diameter >25 mm. Study end-points were stent-related symptoms assessed by a validated questionnaire (ureteral stent symptom questionnaire), administered both before and 4 weeks after surgery. Numerical ureteral stent symptom questionnaire scores were compared using the Mann-Whitney-U-test. The level of significance was defined as P < 0.05.
RESULTS


Ureteroscopy retrograde surgery procedures carried out by 13 surgeons resulted in >90% stone removal in all patients (n = 121), with a mean operation time of 19.9 versus 18.0 min for ureteral catheter versus tubeless, respectively (P = 0.37). Patient groups did not differ significantly in their ureteral stent symptom questionnaire scores (urinary index P = 0.24; pain index P = 0.35). Patients showed a significant preference for tubeless procedure over ureteral catheter reinsertion (Question GQ P < 0.0001). The reintervention rate was 13.3% for the tubeless procedure (n = 8) and 1.6% for the ureteral catheter group (n = 1), respectively (P = 0.034).
CONCLUSIONS


Short-term ureteral catheter and no stent insertion after ureteroscopy retrograde surgery stone extraction in pre-stented patients result in comparable quality of life. However, the reintervention rate is higher for tubeless procedures.",2020,"RESULTS


Ureteroscopy retrograde surgery procedures carried out by 13 surgeons resulted in >90% stone removal in all patients (n = 121), with a mean operation time of 19.9 versus 18.0 min for ureteral catheter versus tubeless, respectively (P = 0.37).","['121 patients with renal or ureteral calculi were initially treated with double-J insertion', 'Exclusion criteria were acute urinary tract infection, solitary kidney or stone diameter >25\xa0mm']","['Transient stent placement versus tubeless procedure after ureteroscopy retrograde surgery stone extraction', 'tubeless versus ureteral catheter insertion for 6\xa0h after ureteroscopy retrograde surgery', 'ureteroscopy retrograde surgery', 'short-term (6\xa0h) ureteral stenting using an external ureteral catheter', 'ureteroscopic stone removal (ureteroscopy retrograde surgery', 'Short-term ureteral catheter and no stent insertion after ureteroscopy retrograde surgery stone extraction']","['mean operation time', 'Numerical ureteral stent symptom questionnaire scores', 'reintervention rate', 'stone removal', 'quality of life', 'tubeless procedure over ureteral catheter reinsertion', 'ureteral stent symptom questionnaire scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0242147', 'cui_str': 'Acute urinary tract infection'}, {'cui': 'C0266294', 'cui_str': 'Renal agenesis, unilateral'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0179799', 'cui_str': 'Ureteral catheter'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]",121.0,0.0665746,"RESULTS


Ureteroscopy retrograde surgery procedures carried out by 13 surgeons resulted in >90% stone removal in all patients (n = 121), with a mean operation time of 19.9 versus 18.0 min for ureteral catheter versus tubeless, respectively (P = 0.37).","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Reicherz', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Maas', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Wenzel', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dahlkamp', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Jüri', 'Initials': 'J', 'LastName': 'Palisaar', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Bodman', 'Affiliation': 'Uroviva Klinik AG, Bülach, Switzerland.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Noldus', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bach', 'Affiliation': 'Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14291']
2882,32974907,"Nifedipine Does Not Alter the Pharmacokinetics of Venlafaxine Enantiomers in Healthy Subjects Phenotyped for CYP2D6, CYP2C19, and CYP3A.","Venlafaxine (VEN) is a P-glycoprotein (P-gp) substrate, and nifedipine has been described by in vitro and experimental studies as a P-gp inhibitor. The present study aimed to investigate whether nifedipine alters the kinetic disposition of VEN enantiomers and their metabolites in healthy subjects. A crossover study was conducted in 10 healthy subjects phenotyped as extensive metabolizers for cytochrome P450 (CYP) 2D6, CYP2C19, and CYP3A. In phase 1, the subjects received a single oral dose of 150 mg racemic VEN, and in phase 2, a single oral dose of 40 mg nifedipine was administered with the VEN treatment. Plasma concentrations of VEN enantiomers and their metabolites O-desmethylvenlafaxine and N, O- didesmethylvenlafaxine (ODV and DDV, respectively) were evaluated by liquid chromatography with tandem mass spectrometry up to 72 hours after drug administration. Phase 2 was compared with phase 1 using the 90% confidence interval (CI) of the ratio of geometric means for C max  and area under the curve (AUC). AUC enantiomeric ratios S-(+)/R-(-) were evaluated within each and between phases using the Wilcoxon test (P ≤ .05). The kinetic disposition of VEN was enantioselective (phase 1) with VEN S-(+)/R-(-) AUC ratio median of 2.83 (AUC 0-∞  , 526 vs 195 ng·h/mL). However, AUC median did not differ between enantiomers for the metabolites ODV (1971 vs 2226 ng·h/mL) and DDV (199 vs 151 ng·h/mL). The 90%CI of the ratio of geometric means showed that the phases are bioequivalent. A single oral dose of 40 mg nifedipine did not alter VEN enantiomer pharmacokinetics in healthy subjects.",2020,"AUC ratio median of 2.83 (AUC 0-∞  , 526 vs 195 ng·h/mL).","['10 healthy subjects phenotyped as extensive metabolizers for cytochrome P450', 'Healthy Subjects Phenotyped for CYP2D6, CYP2C19, and CYP3A', 'healthy subjects']","['VEN S-(+)/R', 'Venlafaxine (VEN', 'Nifedipine', 'nifedipine', 'single oral dose of 150 mg racemic VEN']","['Plasma concentrations of VEN enantiomers and their metabolites O-desmethylvenlafaxine and N, O- didesmethylvenlafaxine (ODV and DDV, respectively', 'AUC enantiomeric ratios S-(+)/R', 'ratio of geometric means for C max  and area under the curve (AUC', 'VEN enantiomer pharmacokinetics', 'AUC ratio median', 'Pharmacokinetics of Venlafaxine Enantiomers']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C0057223', 'cui_str': 'Cytochrome p450 CYP2D6 enzyme'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1880288', 'cui_str': 'Desvenlafaxine'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0969471', 'cui_str': 'N,O-didesmethylvenlafaxine'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",10.0,0.0383251,"AUC ratio median of 2.83 (AUC 0-∞  , 526 vs 195 ng·h/mL).","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Tozatto', 'Affiliation': 'Department of Clinical, Toxicological and Bromatological Analyses, School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Jhohann Richard de Lima', 'Initials': 'JRL', 'LastName': 'Benzi', 'Affiliation': 'Department of Clinical, Toxicological and Bromatological Analyses, School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Rocha', 'Affiliation': 'Department of Clinical, Toxicological and Bromatological Analyses, School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Eduardo Barbosa', 'Initials': 'EB', 'LastName': 'Coelho', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Vera Lucia', 'Initials': 'VL', 'LastName': 'Lanchote', 'Affiliation': 'Department of Clinical, Toxicological and Bromatological Analyses, School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil.'}]",Journal of clinical pharmacology,['10.1002/jcph.1745']
2883,32974931,Iron status and self-reported fatigue in blood donors.,"Fatigue is a reported symptom of iron depletion, but studies in blood donors show no conclusive link. We conducted an observational analysis of data from the STRIDE randomized trial to evaluate association of iron status with self-reported fatigue.
STUDY DESIGN AND METHODS


Three blood centers randomly assigned 692 frequent donors to education or iron supplementation treatments. Biomarkers for iron status were measured during 20 to 24 months of follow-up. A fatigue score was derived from an 11-item questionnaire at baseline and final visits, and associations between iron status and fatigue were assessed.
RESULTS


Final lab and questionnaire data were evaluable from 337 subjects. At baseline, female sex, older age, and anemia were associated with fatigue, but iron status was not. Mean (±SD) fatigue score change was 0.0 (±0.5). Mean (±SD) increase in iron stores was 1.0 (±3.5) mg/kg, but changes in body iron stores were not associated with fatigue score changes (0.01 per mg/kg; 95% CI, -0.01 to 0.02) or with fatigue (RR, 1.01; 95% CI, 0.99 to 1.04). The only factor associated with fatigue score changes was baseline fatigue (0.36; 95% CI, 0.25 to 0.48).
CONCLUSION


Among high-frequency donors, neither iron status at baseline nor changes in iron status predicted fatigue during follow-up, with improvements limited to those with higher levels of baseline fatigue. Assessment of the association between iron and fatigue in blood donors benefits from careful consideration of study design and the study population.",2020,"The only factor associated with fatigue score changes was baseline fatigue (0.36; 95% CI, 0.25 to 0.48).
","['Three blood centers randomly assigned 692 frequent donors to', '337 subjects']",['education or iron supplementation treatments'],"['fatigue score changes', 'Mean (±SD) fatigue score change', 'body iron stores', 'A fatigue score', 'Mean (±SD) increase in iron stores']","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",692.0,0.0920332,"The only factor associated with fatigue score changes was baseline fatigue (0.36; 95% CI, 0.25 to 0.48).
","[{'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Spencer', 'Affiliation': 'American Red Cross, Scientific Affairs, Dedham, Massachusetts, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Wise', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Ritchard G', 'Initials': 'RG', 'LastName': 'Cable', 'Affiliation': 'American Red Cross, Scientific Affairs, Dedham, Massachusetts, USA.'}, {'ForeName': 'Alan E', 'Initials': 'AE', 'LastName': 'Mast', 'Affiliation': 'Blood Research Institute, Versiti, Milwaukee, Wisconsin, USA.'}]",Transfusion,['10.1111/trf.16095']
2884,32973566,Minimal Influence of Hypobaria on Heart Rate Variability in Hypoxia and Normoxia.,"Introduction


The present study evaluated the putative effect of hypobaria on resting HRV in normoxia and hypoxia.
Methods


Fifteen young pilot trainees were exposed to five different conditions in a randomized order: normobaric normoxia (NN, P B  = 726 ± 5 mmHg, F I O 2  = 20.9%), hypobaric normoxia (HN, P B  = 380 ± 6 mmHg, F I O 2 ≅40%), normobaric hypoxia (NH, P B  = 725 ± 4 mmHg, F I O 2 ≅11%); and hypobaric hypoxia (HH at 3000 and 5500 m, HH3000 and HH5500, P B  = 525 ± 6 and 380 ± 8 mmHg, respectively, F I O 2  = 20.9%). HRV and pulse arterial oxygen saturation (SpO 2 ) were measured at rest seated during a 6 min period in each condition. HRV parameters were analyzed (Kubios HVR Standard, V 3.0) for time (RMSSD) and frequency (LF, HF, LF/HF ratio, and total power). Gas exchanges were collected at rest for 10 min following HRV recording.
Results


SpO 2  decreased in HH3000 (95 ± 3) and HH5500 (81 ± 5), when compared to NN (99 ± 0). SpO 2  was higher in NH (86 ± 4) than HH5500 but similar between HN (98 ± 2) and NN. Participants showed lower RMSSD and total power values in NH and HH5500 when compared to NN. In hypoxia, LF/HF ratio was greater in HH5500 than NH, whereas in normoxia, LF/HF ratio was lower in HN than NN. Minute ventilation was higher in HH5500 than in all other conditions.
Discussion


The present study reports a slight hypobaric effect either in normoxia or in hypoxia on some HRV parameters. In hypoxia, with a more prominent sympathetic activation, the hypobaric effect is likely due to the greater ventilation stimulus and larger desaturation. In normoxia, the HRV differences may come from the hyperoxic breathing and slight breathing pattern change due to hypobaria in HN.",2020,Participants showed lower RMSSD and total power values in NH and HH5500 when compared to NN.,['Methods\n\n\nFifteen young pilot trainees'],[],"['time (RMSSD) and frequency (LF, HF, LF/HF ratio, and total power', 'hypoxia, LF/HF ratio', 'HRV and pulse arterial oxygen saturation (SpO 2 ', 'lower RMSSD and total power values', 'HRV parameters', 'hypobaric hypoxia', 'normoxia, LF/HF ratio', 'Minute ventilation']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}]",,0.0243554,Participants showed lower RMSSD and total power values in NH and HH5500 when compared to NN.,"[{'ForeName': 'Mathias Roland', 'Initials': 'MR', 'LastName': 'Aebi', 'Affiliation': 'Swiss Aeromedical Center, Swiss Air Force, Dübendorf, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bourdillon', 'Affiliation': 'Institute of Sport Sciences, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Bron', 'Affiliation': 'Swiss Aeromedical Center, Swiss Air Force, Dübendorf, Switzerland.'}, {'ForeName': 'Grégoire P', 'Initials': 'GP', 'LastName': 'Millet', 'Affiliation': 'Institute of Sport Sciences, University of Lausanne, Lausanne, Switzerland.'}]",Frontiers in physiology,['10.3389/fphys.2020.01072']
2885,32973577,A Novel Treatment of Opioid Cravings With an Effect Size of .73 for Unilateral Transcranial Photobiomodulation Over Sham.,"Background


Opioid use disorders (OUDs) are an epidemic causing catastrophic consequences to individuals, families, and society despite treatments including psychotherapy, substitution therapy or receptor blockers, and psychoeducation. We have developed a novel treatment that combines unilateral transcranial photobiomodulation (t-PBM) to the hemisphere with a more positive valence by Dual Brain Psychology (DBP).
Methods


We used a randomized, double blind, placebo-controlled protocol in which 22 patients with significant opioid cravings and a history of recent or current OUD attended three 1-h weekly sessions. After baseline measures of opioid craving and other psychometrics, subjects received two unilateral t-PBM applications (810 nm CW LED, 250 mW/cm 2 , 60 J/cm 2 , 4 min) or a sham (foil-covered LED) at F3 or F4. Prior to any treatment we used two tests to determine which hemisphere was more associated with a negative outlook and cravings and treated that side before the more positive hemisphere. Primary outcome measure was an opioid craving scale (OCS). Secondary outcomes were weekly Hamilton Depression (HDRS) and Anxiety (HARS) Rating Scales prior to treatments and at follow-up.
Results


Immediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071. The effect size for the differences between active and sham was 0.73. For the active treatment from before and after treatment the effect size was 1.51 and for the sham, 0.45. The HDRS improved from a baseline of 15.1 to 8.8 (SD 10.3) a week after the active treatment and to 13.3 (SD 12.9) after the sham (p = 0.0071). HARS improved from 14.7 to 8.0 (SD 13.2) after the active treatments and to 14.3 (SD 16.0) after the sham, p = 0.08. Active treatment of the positive hemisphere after the negative hemisphere significantly improved the OCS, but there was no significant difference after the sham treatment. One patient complained of 2 h of abdominal bloating and dropped out; no other adverse effects were observed.
Discussion


Unilateral t-PBM to the hemisphere with a more positive hemispheric emotional valence was an effective and safe treatment for opioid cravings as well as for depression and anxiety. Our results also lend support to the underlying premises of DBP.",2020,"Immediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071.",['22 patients with significant opioid cravings and a history of recent or current OUD attended three 1-h weekly sessions'],"['unilateral transcranial photobiomodulation (t-PBM', 'placebo', 'unilateral t-PBM applications']","['abdominal bloating', 'OCS', 'positive hemispheric emotional valence', 'weekly Hamilton Depression (HDRS) and Anxiety (HARS', 'adverse effects', 'opioid craving scale (OCS', 'HDRS', 'HARS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",22.0,0.301561,"Immediately after treatment the OCS improved significantly for both the sham and active treatments, but one week later the active treatment showed a 51.0% (SD 33.7) decrease in OCS while a week after the sham treatments there was a decrease of only 15.8% (SD 35.0) (by Wilcoxon Sign Rank Test, p = 0.004) and by a mixed model it was p = 0.0071.","[{'ForeName': 'Fredric', 'Initials': 'F', 'LastName': 'Schiffer', 'Affiliation': 'MindLight, LLC, Newton Highlands, MA, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Reichmann', 'Affiliation': 'Independent Consultant, Danvers, MA, United States.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Flynn', 'Affiliation': 'MindLight, LLC, Newton Highlands, MA, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Hamblin', 'Affiliation': 'Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McCormack', 'Affiliation': 'MindLight, LLC, Newton Highlands, MA, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00827']
2886,32973581,Effectiveness and Cost-Effectiveness of Internet-Based Cognitive Behavioral Therapy for Insomnia in Clinical Settings.,"Background


Internet-delivered cognitive-behavior treatment for insomnia (iCBT-I) has the potential to fill the gap created by the discrepancy between insomnia cases and number of trained professionals. Although the effectiveness of this method was proven in multiple studies conducted in research settings, its feasibility in routine care is still unclear. Predictors, mediators, and moderators of treatment effect remain uncertain since previous studies often give contradictory results. The present study aims to investigate clinical effectiveness and cost-effectiveness of an internet-based CBT-I program Sleepsy in comparison with care as usual (CAU) among patients with CI recruited from clinical settings. Baseline data will be further analyzed to find predictors of treatment outcome.
Methods/Design


The proposed study is a parallel-group randomized controlled trial comparing CAU plus iCBT-I with CAU in a clinical setting. One hundred ten participants will be referred from the medical doctors in Moscow. Both groups will have access to CAU, which corresponds to the treatment prescribed by the referring doctor. Patients of the first group will additionally get access to the iCBT-I program with the opportunity to contact a specialist (guidance on request) in a secured environment. The primary outcome is insomnia severity change from pre- to post-treatment. Secondary outcomes include change of subjective sleep characteristics, life quality, fatigue, daytime sleepiness, comorbid affective disorders, dysfunctional beliefs about sleep, sleep hygiene, healthcare consumption, productivity losses, and longer term outcomes at 3 months follow-up. Predictor analysis will include baseline scores of the aforementioned outcomes along with treatment expectancies and personality traits.
Discussion


The proposed study is one of the first studies evaluating whether iCBT-I also works in routine care. We expect that recruitment of the participants let us determine the target group more precisely and exclude health problems interfering with treatment. Using CAU as control condition may result in a loss of power to detect a meaningful difference. Nevertheless, this approach is reasonable since it reconstructs the clinical situation faced by practicing doctors.",2020,"Background


Internet-delivered cognitive-behavior treatment for insomnia (iCBT-I) has the potential to fill the gap created by the discrepancy between insomnia cases and number of trained professionals.","['One hundred ten participants will be referred from the medical doctors in Moscow', 'patients with CI recruited from clinical settings']","['CAU plus iCBT-I with CAU', 'internet-based CBT-I program Sleepsy', 'Internet-Based Cognitive Behavioral Therapy', '\n\n\nInternet-delivered cognitive-behavior treatment']","['Effectiveness and Cost-Effectiveness', 'clinical effectiveness and cost-effectiveness', 'change of subjective sleep characteristics, life quality, fatigue, daytime sleepiness, comorbid affective disorders, dysfunctional beliefs about sleep, sleep hygiene, healthcare consumption, productivity losses, and longer term outcomes', 'insomnia severity change from pre- to post-treatment']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0026580', 'cui_str': 'Moscow'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",110.0,0.0845994,"Background


Internet-delivered cognitive-behavior treatment for insomnia (iCBT-I) has the potential to fill the gap created by the discrepancy between insomnia cases and number of trained professionals.","[{'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'Pchelina', 'Affiliation': 'Institute of Psychology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Poluektov', 'Affiliation': 'Sleep Medicine Department, University Clinical Hospital No3, I.M. Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Institute of Psychology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Institute of Psychology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Simone B', 'Initials': 'SB', 'LastName': 'Duss', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Department of Neurology, Inselspital, Bern University Hospital, University Bern, Bern, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bassetti', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Department of Neurology, Inselspital, Bern University Hospital, University Bern, Bern, Switzerland.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00838']
2887,32975024,Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: A post hoc analysis from the MATCH study.,"OBJECTIVES


To investigate the cardiovascular safety of mirabegron add-on treatment to tamsulosin in male patients with residual overactive bladder symptoms.
METHODS


This was a post hoc analysis of MATCH, the first double-blind, placebo-controlled study comparing mirabegron and placebo as add-on therapy to tamsulosin for treatment of overactive bladder in men with lower urinary tract symptoms. The analysis focused on treatment-emergent adverse events relating to the cardiovascular system or blood pressure, and changes in vital signs during 12 weeks of follow-up.
RESULTS


Cardiovascular-related treatment-emergent adverse events were reported by 6/566 patients, although only one serious treatment-emergent adverse event was related to treatment (unstable angina in the tamsulosin + placebo group). Hypertension (two patients) and increased blood pressure (one patient) were reported in the tamsulosin + placebo group, but there were no blood pressure-related treatment-emergent adverse events among tamsulosin + mirabegron patients. There were no clinically meaningful changes from baseline in blood pressure, and changes in pulse rate were small (+1.2 bpm in the tamsulosin + mirabegron group). Increased pulse rate was more frequent with tamsulosin + mirabegron than with tamsulosin + placebo in older patients, although within the normal range.
CONCLUSIONS


Cardiovascular-related adverse events were uncommon in both treatment groups. Mirabegron is a well-tolerated add-on therapy to tamsulosin in Japanese and Korean males with residual overactive bladder symptoms.",2020,"Hypertension (two patients) and increased blood pressure (one patient) were reported in the tamsulosin + placebo group, but there were no blood pressure-related treatment-emergent adverse events among tamsulosin + mirabegron patients.","['older patients', 'men with lower urinary tract symptoms', 'Japanese and Korean males with residual overactive bladder symptoms', 'male patients with residual overactive bladder symptoms']","['mirabegron and placebo', 'tamsulosin\u2009+\u2009placebo', 'tamsulosin', 'placebo']","['blood pressure-related treatment-emergent adverse events', 'blood pressure, and changes in pulse rate', 'blood pressure, and changes in vital signs', 'blood pressure', 'Hypertension', 'Cardiovascular-related treatment-emergent adverse events', 'Cardiovascular safety', 'pulse rate']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0788985,"Hypertension (two patients) and increased blood pressure (one patient) were reported in the tamsulosin + placebo group, but there were no blood pressure-related treatment-emergent adverse events among tamsulosin + mirabegron patients.","[{'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Katoh', 'Affiliation': 'Clinic at Tobu Railway Co Ltd, Tokyo, Japan.'}, {'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Kakizaki', 'Affiliation': 'Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Kyu-Sung', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Katou', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamamoto', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Jar Jar', 'Initials': 'JJ', 'LastName': 'Jong', 'Affiliation': 'Astellas Pharma, Singapore.'}, {'ForeName': 'Budiwan', 'Initials': 'B', 'LastName': 'Sumarsono', 'Affiliation': 'Astellas Pharma, Singapore.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Uno', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Bioengineering and LUTD Research, Nihon University School of Engineering, Koriyama, Japan.'}]",Lower urinary tract symptoms,['10.1111/luts.12339']
2888,32975061,"A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial.","PURPOSE


To investigate the efficacy and safety of a newly developed thermo-responsive sol-gel, ABT13107, for reducing the formation of intrauterine adhesions (IUAs) after hysteroscopic surgery.
MATERIALS AND METHODS


In this multicenter, prospective, randomized trial (Canadian Task Force classification I), 192 women scheduled to undergo a hysteroscopic surgery at one of the eight university hospitals in South Korea were randomized into the ABT13107 group or the comparator (Hyalobarrier®) group in a 1:1 ratio. During hysteroscopic surgery, ABT13107 or Hyalobarrier® was injected to sufficiently cover the entire intrauterine cavity.
RESULTS


The patients returned to their respective sites for safety assessments at postoperative weeks 1 and 4 and for efficacy assessments at postoperative week 4. The post-surgery incidence of IUAs was 23.4% in the ABT13107 group and 25.8% in the comparator group; this difference met the criteria for ABT13107 to be considered as not inferior to the comparator. No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups. Most adverse events were mild in severity, and no serious adverse events occurred.
CONCLUSION


ABT13107, a new anti-adhesive barrier containing hyaluronic acid, was not inferior to the highly viscous hyaluronic acid anti-adhesive barrier, Hyalurobarrier® in IUA formation after hysteroscopic surgery (Clinical trial registration No. NCT04007211).",2020,"No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups.","['192 women scheduled to undergo a hysteroscopic surgery at one of the eight university hospitals in South Korea', 'Intrauterine Adhesions after Hysteroscopic Surgery']","['Hyaluronic Acid Sol-Gel', 'ABT13107 group or the comparator (Hyalobarrier®']","['efficacy and safety', 'extent of adhesions, types of adhesions, or the cumulative American Fertility Society score', 'post-surgery incidence of IUAs']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0751614', 'cui_str': 'Surgical Procedures, Hysteroscopic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0241593', 'cui_str': 'Adhesions of uterus'}]",192.0,0.121343,"No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups.","[{'ForeName': 'Dong Yun', 'Initials': 'DY', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics & Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sa Ra', 'Initials': 'SR', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics & Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seul Ki', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics & Gynecology, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Jong Kil', 'Initials': 'JK', 'LastName': 'Joo', 'Affiliation': 'Department of Obstetrics & Gynecology, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Woo Shun', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Medytox Inc., Seoul, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Obstetrics & Gynecology, Guro Hospital, College of Medicine, Korea University, Seoul, Korea.'}, {'ForeName': 'SiHyun', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Obstetrics & Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joon Cheol', 'Initials': 'JC', 'LastName': 'Park', 'Affiliation': 'Department of Obstetrics & Gynecology, Keimyung University School of Medicine, Daegu, Korea. jcpark@dsmc.or.kr.'}, {'ForeName': 'Sung Hoon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics & Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. kimsung@amc.seoul.kr.'}]",Yonsei medical journal,['10.3349/ymj.2020.61.10.868']
2889,32975088,[Effects of Different Chemoradiotherapy Regimens on Early Survival Outcomes in Patients with Locally Advanced Nasopharyngeal Carcinoma].,"Objective


To compare the early survival outcomes of patients with locally advanced nasopharyngeal carcinoma received EPF (epirubicin, cisplatin and fluorouracil) induced chemotherapy combined with concurrent nimotuzumab with radiotherapy (CNRT) or DPF (docetaxel, cisplatin and fluorouracil) induced chemotherapy combined with concurrent chemoradiotherapy (CCRT).
Methods


Patients with locally advanced nasopharyngeal carcinoma (stage Ⅲ to Ⅳb) from March 2010 to September 2017 were included. The primary endpoint was disease-free survival (DFS). The secondary endpoints were distant metastasis-free survival (DMFS), local recurrence-free survival (LRFS), and overall survival (OS). Propensity score matching was used to balance the differences in clinical characteristics between the two groups. Kaplan-Meier method and log-rank test were used to compare the survival differences between the two groups. Multivariate Cox proportional hazards model was used to identify potential prognostic factors.
Results


After matching, a total of 153 patients were enrolled, including 51 patients in the EPF combined with CNRT group and 102 patients in the DPF combined with CCRT group. There was no difference in 2-year DFS (82.4% vs. 85.3%,  P =0.880), OS (88.2% vs. 96.0%,  P =0.410), LRFS (100.0% vs. 92.1%,  P =0.278), and DMFS (82.3% vs. 88.2%,  P =0.120) between EPF combined with CNRT group and DPF combined with CCRT group. Treatment regimen (EPF combined with CNRT vs. DPF combined with CCRT) was not an independent prognostic factor of DFS (hazard ratio ( HR )=0.530,  P =0.075). In the subgroup analyses, EPF combined with CNRT could reduce the risk of disease progression in T 3  ( HR =0.174,  P =0.045), N 1 /N 2  ( HR =0.432,  P =0.036), and male patients ( HR =0.437,  P =0.044). During concurrent radiotherapy, the incidence of grade 3-4 neutropenia in EPF combined with CNRT was significantly lower than that of DPF combined with CCRT ( P =0.007).
Conclusion


EPF combined with CNRT regimen is similar to DPF combined with CCRT regimen in survival outcomes, but the patients with T 3 , N 1 /N 2 , and male nasopharyngeal carcinoma may benefit from EPF combined with CNRT regimen.",2020,"The secondary endpoints were distant metastasis-free survival (DMFS), local recurrence-free survival (LRFS), and overall survival (OS).","['Patients with Locally Advanced Nasopharyngeal Carcinoma', 'patients with locally advanced nasopharyngeal carcinoma', 'Patients with locally advanced nasopharyngeal carcinoma (stage Ⅲ to Ⅳb) from March 2010 to September 2017 were included', '153 patients were enrolled, including 51 patients in the EPF combined with CNRT group and 102 patients in the DPF combined with CCRT group']","['CNRT', 'EPF (epirubicin, cisplatin and fluorouracil) induced chemotherapy combined with concurrent nimotuzumab with radiotherapy (CNRT) or DPF (docetaxel, cisplatin and fluorouracil) induced chemotherapy combined with concurrent chemoradiotherapy (CCRT', 'Chemoradiotherapy Regimens', 'CCRT', 'EPF combined with CNRT vs. DPF combined with CCRT']","['survival differences', 'distant metastasis-free survival (DMFS), local recurrence-free survival (LRFS), and overall survival (OS', 'Early Survival Outcomes', '2-year DFS', 'disease-free survival (DFS', 'DMFS', 'LRFS', 'OS', 'risk of disease progression', 'survival outcomes', 'incidence of grade 3-4 neutropenia', 'early survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1570308', 'cui_str': 'Nimotuzumab'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1570308', 'cui_str': 'Nimotuzumab'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",153.0,0.133985,"The secondary endpoints were distant metastasis-free survival (DMFS), local recurrence-free survival (LRFS), and overall survival (OS).","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Head and Neck Oncology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Head and Neck Oncology, West China Hospital, Sichuan University, Chengdu 610041, China.'}]",Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition,['10.12182/20200960107']
2890,32975131,Timed physical exercise does not influence circadian rhythms and glucose tolerance in rotating night shift workers: The EuRhythDia study.,"OBJECTIVES


Night shift workers are at cardiometabolic risk due to circadian misalignment. We investigated whether infrequent exercise before each night shift that intentionally would not improve physical performance improves glucose tolerance and 24-h blood pressure profiles and synchronizes circadian rhythms of melatonin and cortisol in rotating night shift workers.
METHODS


A total of 24 rotating night shift workers (mean age, 35.7 ± 11.8 years) were randomized to exercise or no intervention. Workers in the exercise group performed 15.2 ± 4.5 exercise sessions within 2 h before each night shift. Before and after 12 weeks of exercise intervention and 12 weeks after the intervention, spiroergometry, oral glucose tolerance testing and 24-h blood pressure profiles were performed. Plasma melatonin and cortisol levels were measured in 3-hourly intervals during one 24-h period on each study day.
RESULTS


Exercise did not significantly change serum glucose nor insulin levels during oral glucose tolerance testing. Timed physical exercise had no effect on physical performance, nor did it change the circadian rhythms of melatonin and cortisol or influence 24-h blood pressure profiles.
CONCLUSION


Physical exercise before each night shift at a low intensity level that does not improve physical performance does not affect circadian timing, glucose tolerance or 24-h blood pressure profiles in rotating night shift workers.",2020,"Timed physical exercise had no effect on physical performance, nor did it change the circadian rhythms of melatonin and cortisol or influence 24-h blood pressure profiles.
","['24 rotating night shift workers (mean age, 35.7\u2009±\u200911.8\u2009years', 'rotating night shift workers']","['exercise intervention', 'exercise or no intervention', 'Physical exercise', 'Timed physical exercise']","['Plasma melatonin and cortisol levels', 'circadian rhythms and glucose tolerance', 'physical performance', 'change serum glucose nor insulin levels', 'circadian rhythms of melatonin and cortisol or influence 24-h blood pressure profiles', 'circadian timing, glucose tolerance or 24-h blood pressure profiles', 'glucose tolerance and 24-h blood pressure profiles']","[{'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0555008', 'cui_str': 'Night shift worker'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449243', 'cui_str': 'Timing'}]",24.0,0.0167964,"Timed physical exercise had no effect on physical performance, nor did it change the circadian rhythms of melatonin and cortisol or influence 24-h blood pressure profiles.
","[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Hannemann', 'Affiliation': 'Institute of Clinical Pharmacology and Toxicology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Laing', 'Affiliation': 'Institute of Clinical Pharmacology and Toxicology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Glismann', 'Affiliation': 'Institute of Clinical Pharmacology and Toxicology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Debra J', 'Initials': 'DJ', 'LastName': 'Skene', 'Affiliation': 'Chronobiology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Benita', 'Initials': 'B', 'LastName': 'Middleton', 'Affiliation': 'Chronobiology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Staels', 'Affiliation': 'Univ. Lille, Inserm, CHU Lille, Institut Pasteur de Lille, U1011-EGID, Lille, France.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Cardiology, University Medical Center Aachen, Aachen, Germany.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Grant', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Federici', 'Affiliation': ""Center for Atherosclerosis, School of Medicine, University of Rome 'Tor Vergata', Rome, Italy.""}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'University Institute for Preventive and Rehabilitative Sports Medicine, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Böger', 'Affiliation': 'Institute of Clinical Pharmacology and Toxicology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Diabetes & vascular disease research,['10.1177/1479164120950616']
2891,32975159,Effect of a Housing Intervention on Selected Cardiovascular Risk Factors Among Homeless Adults With Mental Illness: 24-Month Follow-Up of a Randomized Controlled Trial.,"Background Cardiovascular disease is a leading cause of mortality among people experiencing homelessness. This study investigated whether housing intervention affects cardiovascular disease risk factors among homeless adults with mental illnesses over a 24-month period. Methods and Results We conducted a randomized controlled trial of a Housing First intervention that provided community-based scattered-site housing and support services. Five hundred seventy-five participants were randomized to the intervention (n=301) or treatment as usual (TAU) (n=274). Analyses were performed according to the intention-to-treat principle using generalized estimating equations. There were no differences in change over 24 months between the 2 groups for blood pressure, tobacco, and cocaine/crack use. However, the intervention had an impact on reducing the number of days of alcohol intoxication by 1.58 days compared with TAU (95% CI, -2.88 to -0.27,  P =0.0018). Over the 24-month period, both the intervention and TAU groups had significant reductions in tobacco and cocaine use. Conclusions The intervention, compared with TAU, did not result in greater improvements in many of the selected cardiovascular risk factors. Since the study took place in a service-rich city with a range of pre-existing supportive services and universal health insurance, the high level of usual services available to the TAU group may have contributed to reductions in their cardiovascular disease risk factors. Further research is needed to develop interventions to reduce risk factors of cardiovascular disease among people experiencing homelessness and mental illness beyond existing treatments. REGISTRATION www.isrctn.comURL: www.isrctn.com. Unique Identifier: ISRCTN42520374.",2020,"There were no differences in change over 24 months between the 2 groups for blood pressure, tobacco, and cocaine/crack use.","['people experiencing homelessness', 'Five hundred seventy-five participants', 'homeless adults with mental illnesses over a 24-month period', 'Homeless Adults With Mental Illness']","['Housing First intervention that provided community-based scattered-site housing and support services', 'Housing Intervention', 'housing intervention']","['Selected Cardiovascular Risk Factors', 'blood pressure, tobacco, and cocaine/crack use', 'cardiovascular disease risk factors', 'number of days of alcohol intoxication']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439742', 'cui_str': 'Scattered'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}]",575.0,0.137546,"There were no differences in change over 24 months between the 2 groups for blood pressure, tobacco, and cocaine/crack use.","[{'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Chum', 'Affiliation': 'Brock University St. Catharines ON Canada.'}, {'ForeName': 'Ri', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Unity Health Toronto Toronto ON Canada.'}, {'ForeName': 'Rosane', 'Initials': 'R', 'LastName': 'Nisenbaum', 'Affiliation': 'Unity Health Toronto Toronto ON Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Campo"", 'Affiliation': 'Unity Health Toronto Toronto ON Canada.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Stergiopoulos', 'Affiliation': 'Unity Health Toronto Toronto ON Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Unity Health Toronto Toronto ON Canada.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.016896']
2892,32975164,Improving measurement feedback systems for measurement-based care.,"Abstract   Objectives:  Measurement feedback systems (MFS) are a class of health information technologies developed to facilitate measurement-based care. The individual clinical decision support features within MFS are diverse and their influence on clinicians is largely unknown. This study tested the impact of MFS features on clinicians' progress assessments and treatment decisions in different scenarios.  Method:  Clinicians ( n  = 299) were randomly assigned to view one of six combinations of the following MFS features: graph, expected change trajectory line, alert, and treatment suggestions. The assigned feature combination was paired with three vignettes and clinical data representing three clinical scenarios: patient deterioration, no progress, and approaching remission. Clinicians answered questions after each vignette, and at the conclusion.  Results:  MFS features differentially impacted clinicians' progress assessment accuracy, their likelihood of making a treatment change, and their treatment choices. Which feature was most impactful varied depending on the clinical scenario. Clinicians reported graphs influenced their assessments and choices significantly more than the other features, and the majority stated they would prefer to use all of the features.  Conclusions:  Specific MFS features impact clinicians' assessments and choices to greater degrees, and the impact of those features can be influenced by the clinical state of the patient.",2020,"MFS features differentially impacted clinicians' progress assessment accuracy, their likelihood of making a treatment change, and their treatment choices.",['Method:  Clinicians ( n \u2009=\u2009299'],['Measurement feedback systems (MFS'],[],"[{'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}]",[],299.0,0.0407696,"MFS features differentially impacted clinicians' progress assessment accuracy, their likelihood of making a treatment change, and their treatment choices.","[{'ForeName': 'A Paige', 'Initials': 'AP', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, USA.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Fagan', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1823031']
2893,32975391,Combined exercise training improves blood pressure at rest and during exercise in young obese prehypertensive men.,"BACKGROUND


Regular exercise is an effective intervention to yield health-related benefits, though an optimal dosage and its ability to improve hemodynamics at rest and during exercise are yet to be established. Therefore, this study aimed to assess the effects of a combined (aerobic and resistance) exercise training program on hemodynamic variables at rest and during exercise in young obese prehypertensive men.
METHODS


Twenty obese prehypertensive men (age: 20±1.2 years) were randomly assigned to either the combined exercise training group (CBT, n=10), or the control group (CON, n=10). The CBT underwent a supervised combined exercise training program incorporating four 60-min sessions per week over 12 weeks, whereas the CON remained in habitual activities. We assessed BP, peak oxygen consumption (V̇ O2peak), body composition, muscular strength, and hemodynamic responses to incremental exercise at baseline and post intervention.
RESULTS


The study revealed significant improvements in resting systolic blood pressure (SBP) of 4.3% (P<0.05), and rate-pressure product (RPP) of 11.3% (P<0.05) following 12 weeks of training. Significant reductions in SBP and RPP during exercise were also present at every exercise intensity. Moreover, the CBT training improved V̇ O2peak by 18.2% (P<0.01), upper body muscle strength by 15.1% (P<0.01), and reduced body fat (P<0.01).
CONCLUSIONS


The CBT is effective in reducing SBP and myocardial oxygen demand at rest and during exercise. It can also improve cardiorespiratory fitness, muscular strength, and reduce body fat; especially in terms of abdominal obesity. Thus, we suggest the use of the CBT program for the prevention of future hypertension in young obese prehypertensive men.",2020,"Moreover, the CBT training improved V̇ O2peak by 18.2% (P<0.01), upper body muscle strength by 15.1% (P<0.01), and reduced body fat (P<0.01).
","['Twenty obese prehypertensive men (age: 20±1.2 years', 'young obese prehypertensive men']","['combined exercise training group (CBT', 'CBT', 'CBT program', 'Combined exercise training', 'combined (aerobic and resistance) exercise training program']","['resting systolic blood pressure (SBP', 'V̇ O2peak', 'rate-pressure product (RPP', 'blood pressure', 'upper body muscle strength', 'SBP and RPP', 'BP, peak oxygen consumption (V̇ O2peak), body composition, muscular strength, and hemodynamic responses to incremental exercise', 'cardiorespiratory fitness, muscular strength, and reduce body fat', 'SBP and myocardial oxygen demand']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",20.0,0.0147352,"Moreover, the CBT training improved V̇ O2peak by 18.2% (P<0.01), upper body muscle strength by 15.1% (P<0.01), and reduced body fat (P<0.01).
","[{'ForeName': 'Jatuporn', 'Initials': 'J', 'LastName': 'Phoemsapthawee', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand - jatuporn.w@ku.th.'}, {'ForeName': 'Bhuwanat', 'Initials': 'B', 'LastName': 'Sriton', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11222-2']
2894,32975441,"EEG biomarkers acquired during a short, straight-line simulated drive to predict impairment from cannabis intoxication.","OBJECTIVE


As cannabis use becomes more widely accepted, there is growing interest in its effects on brain function, specifically how it may impact daily functional activities such as driving, operating machinery, and other safety-related tasks. There are currently no validated methods for quantifying impairment from acute cannabis intoxication. The objective of this study was to identify neurophysiological correlates associated with driving simulator performance in subjects who were acutely intoxicated with cannabis. These signatures could help create an EEG-based profile of impairment due to acute cannabis intoxication.
METHODS


Each subject completed a three-visit study protocol. Subjects were consented and screened on the first visit. On the second and third visits, subjects were administered either 500 mg of cannabis with 6.7% delta-9-tetrahydrocannabinol (THC) or placebo using a Volcano© Digit Vaporizer in a counterbalanced fashion. EEG was acquired from subjects as they performed a series of neurocognitive tasks and an approximately 45-minute simulated drive that included a rural straight-away absent of any other cars or obstacles during the final 10 minutes. EEG data was acquired using a STAT X24 wireless sensor headset during a simulated driving scenario from 10 subjects during the THC and placebo visits. Metrics of driving performance were extracted from the driving simulator and synchronized with EEG data using a common clock.
RESULTS


A within-subjects analysis showed that the standard deviation of lane position (SDLP) was significantly worse and heart rate was elevated during the dosed visit compared to the placebo visit. Consistent with our prior findings, EEG power in the Theta frequency band (4-7 Hz) in the dosed condition was significantly decreased from the placebo condition. Theta power was negatively correlated with the SDLP driving performance metric, while there were no significant correlations between any EEG measure and SDLP in the placebo condition.
CONCLUSIONS


These results, in combination with prior work on the effect of cannabis intoxication during neurocognitive tasks, suggest that neurophysiological signatures associated with acute cannabis intoxication are robust and consistent across tasks, and that these signatures are significantly correlated with impaired performance in a driving simulator. Taken together, EEG data acquired during a short neurocognitive testbed and during a simulated drive may provide specific profiles of impairment associated with acute cannabis intoxication. Further research is needed to establish the impaired cognitive processes associated with these EEG biomarkers.",2020,"Theta power was negatively correlated with the SDLP driving performance metric, while there were no significant correlations between any EEG measure and SDLP in the placebo condition.
",['subjects who were acutely intoxicated with cannabis'],"['placebo', '500\u2009mg of cannabis with 6.7% delta-9-tetrahydrocannabinol']","['standard deviation of lane position (SDLP', 'EEG measure and SDLP', 'heart rate', 'SDLP driving performance metric']","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",,0.120117,"Theta power was negatively correlated with the SDLP driving performance metric, while there were no significant correlations between any EEG measure and SDLP in the placebo condition.
","[{'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Brown', 'Affiliation': 'National Advanced Driving Simulator, The University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Richard', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Meghdadi', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Poole', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Fink', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Stevanović Karić', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'McConnell', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Rupp', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Schmitt', 'Affiliation': 'National Advanced Driving Simulator, The University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Gaffney', 'Affiliation': 'National Advanced Driving Simulator, The University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Milavetz', 'Affiliation': 'National Advanced Driving Simulator, The University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Berka', 'Affiliation': 'Advanced Brain Monitoring, Carlsbad, California.'}]",Traffic injury prevention,['10.1080/15389588.2020.1814957']
2895,32975454,Comparison of Accuracy and Clinical Outcomes of Robot-Assisted Versus Fluoroscopy-Guided Pedicle Screw Placement in Posterior Cervical Surgery.,"STUDY DESIGN


This was a prospective controlled study.
OBJECTIVE


To compare the accuracy and clinical outcomes of robot-assisted (RA) and fluoroscopy-guided (FG) pedicle screw placement in posterior cervical surgery.
METHODS


This study included 58 patients. The primary outcome measures were the 1-time success rate and the accuracy of pedicle screw placement according to the Gertzbein-Robbins scales. The secondary outcome measures, including the operative time, intraoperative blood loss, hospital stay, cumulative radiation time, radiation dose, intraoperative advent events, and postoperative complications, were recorded and analyzed. The Japanese Orthopedics Association (JOA) scores and Neck Disability Index (NDI) were used to assess the neurological function of patients before and at 3 and 6 months after surgery.
RESULTS


The rate of grade A was significantly higher in the RA group than in the FG group (90.6% and 71.1%;  P  < .001). The clinically acceptable accuracy was 97.2% in the RA group and 90.7% in the FG group ( P  = .009). Moreover, the 1-time success rate was significantly higher in the RA group than in the FG group. The RA group had less radiation time ( P  < .001) and less radiation dose ( P  = .002) but longer operative time ( P  = .001). There were no significant differences in terms of intraoperative blood loss, hospital stay, intraoperative adverse events, postoperative complications, JOA scores, and NDI scores at each follow-up time point between the 2 groups.
CONCLUSIONS


The RA technique achieved higher accuracy and 1-time success rate of pedicle screw placement in posterior cervical surgery while achieving comparable clinical outcomes.",2020,"There were no significant differences in terms of intraoperative blood loss, hospital stay, intraoperative adverse events, postoperative complications, JOA scores, and NDI scores at each follow-up time point between the 2 groups.
","['58 patients', 'Posterior Cervical Surgery']","['pedicle screw placement', 'Robot-Assisted Versus Fluoroscopy-Guided Pedicle Screw Placement', 'robot-assisted (RA', 'fluoroscopy-guided (FG) pedicle screw placement']","['operative time', '1-time success rate', 'clinically acceptable accuracy', 'operative time, intraoperative blood loss, hospital stay, cumulative radiation time, radiation dose, intraoperative advent events, and postoperative complications', 'rate of grade A', 'radiation time', 'Japanese Orthopedics Association (JOA) scores and Neck Disability Index (NDI', '1-time success rate and the accuracy of pedicle screw placement according to the Gertzbein-Robbins scales', 'intraoperative blood loss, hospital stay, intraoperative adverse events, postoperative complications, JOA scores, and NDI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}]",58.0,0.0759074,"There were no significant differences in terms of intraoperative blood loss, hospital stay, intraoperative adverse events, postoperative complications, JOA scores, and NDI scores at each follow-up time point between the 2 groups.
","[{'ForeName': 'Xin-Jin', 'Initials': 'XJ', 'LastName': 'Su', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Lv', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ying-Chao', 'Initials': 'YC', 'LastName': 'Han', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qing-Xin', 'Initials': 'QX', 'LastName': 'Song', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Li-Feng', 'Initials': 'LF', 'LastName': 'Lao', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Shen', 'Affiliation': '71140Shanghai Jiao Tong University, Shanghai, China.'}]",Global spine journal,['10.1177/2192568220960406']
2896,32975529,Electronic Health Record Portal Messages and Interactive Voice Response Calls to Improve Rates of Early Season Influenza Vaccination: Randomized Controlled Trial.,"BACKGROUND


Patient reminders for influenza vaccination, delivered via an electronic health record patient portal and interactive voice response calls, offer an innovative approach to engaging patients and improving patient care.
OBJECTIVE


The goal of this study was to test the effectiveness of portal and interactive voice response outreach in improving rates of influenza vaccination by targeting patients in early September, shortly after vaccinations became available.
METHODS


Using electronic health record portal messages and interactive voice response calls promoting influenza vaccination, outreach was conducted in September 2015. Participants included adult patients within a large multispecialty group practice in central Massachusetts. Our main outcome was electronic health record-documented early influenza vaccination during the 2015-2016 influenza season, measured in November 2015. We randomly assigned all active portal users to 1 of 2 groups: (1) receiving a portal message promoting influenza vaccinations, listing upcoming clinics, and offering online scheduling of vaccination appointments (n=19,506) or (2) receiving usual care (n=19,505). We randomly assigned all portal nonusers to 1 of 2 groups: (1) receiving interactive voice response call (n=15,000) or (2) receiving usual care (n=43,596). The intervention also solicited patient self-reports on influenza vaccinations completed outside the clinic. Self-reported influenza vaccination data were uploaded into the electronic health records to increase the accuracy of existing provider-directed electronic health record clinical decision support (vaccination alerts) but were excluded from main analyses.
RESULTS


Among portal users, 28.4% (5549/19,506) of those randomized to receive messages and 27.1% (5294/19,505) of the usual care group had influenza vaccinations documented by November 2015 (P=.004). In multivariate analysis of portal users, message recipients were slightly more likely to have documented vaccinations when compared to the usual care group (OR 1.07, 95% CI 1.02-1.12). Among portal nonusers, 8.4% (1262/15,000) of those randomized to receive calls and 8.2% (3586/43,596) of usual care had documented vaccinations (P=.47), and multivariate analysis showed nonsignificant differences. Over half of portal messages sent were opened (10,112/19,479; 51.9%), and over half of interactive voice response calls placed (7599/14,984; 50.7%) reached their intended target, thus we attained similar levels of exposure to the messaging for both interventions. Among portal message recipients, 25.4% of message openers (2570/10,112) responded to a subsequent question on receipt of influenza vaccination; among interactive voice response recipients, 72.5% of those reached (5513/7599) responded to a similar question.
CONCLUSIONS


Portal message outreach to a general primary care population achieved a small but statistically significant improvement in rates of influenza vaccination (OR 1.07, 95% CI 1.02-1.12). Interactive voice response calls did not significantly improve vaccination rates among portal nonusers (OR 1.03, 95% CI 0.96-1.10). Rates of patient engagement with both modalities were favorable.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02266277; https://clinicaltrials.gov/ct2/show/NCT02266277.",2020,"Interactive voice response calls did not significantly improve vaccination rates among portal nonusers (OR 1.03, 95% CI 0.96-1.10).","['Participants included adult patients within a large multispecialty group practice in central Massachusetts', 'Early Season Influenza Vaccination']","['interactive voice response call (n=15,000) or (2) receiving usual care (n=43,596', 'Electronic Health Record Portal Messages and Interactive Voice Response Calls', 'portal and interactive voice response outreach', 'portal message promoting influenza vaccinations, listing upcoming clinics, and offering online scheduling of vaccination appointments (n=19,506) or (2) receiving usual care (n=19,505']","['influenza vaccinations', 'rates of influenza vaccination', 'Interactive voice response calls', 'vaccination rates']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018262', 'cui_str': 'Group Practice'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.404764,"Interactive voice response calls did not significantly improve vaccination rates among portal nonusers (OR 1.03, 95% CI 0.96-1.10).","[{'ForeName': 'Jessica G', 'Initials': 'JG', 'LastName': 'Wijesundara', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Mayuko', 'Initials': 'M', 'LastName': 'Ito Fukunaga', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ogarek', 'Affiliation': 'Center for Gerontology and Healthcare Research, Brown University, Providence, MA, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Lloyd', 'Initials': 'L', 'LastName': 'Fisher', 'Affiliation': 'Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Preusse', 'Affiliation': 'Reliant Medical Group, Worcester, MA, United States.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Sundaresan', 'Affiliation': 'Reliant Medical Group, Worcester, MA, United States.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Garber', 'Affiliation': 'Meyers Primary Care Institute, Worcester, MA, United States.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'Meyers Primary Care Institute, Worcester, MA, United States.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Cutrona', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, United States.'}]",Journal of medical Internet research,['10.2196/16373']
2897,32975705,Dentifrices or gels containing MMP inhibitors prevent dentine loss: in situ studies.,"OBJECTIVES


Evaluate the effect of dentifrices or gels containing MMP inhibitors on dentine loss in situ.
MATERIALS AND METHODS


Acrylic palatal appliances containing bovine dentine blocks were divided into two rows, corresponding to the groups erosion (ERO) and erosion associated with abrasion (ERO+ABR). For ERO, the appliances were immersed in a cola drink for 5 min, 4 times/day, while for ERO+ABR, the blocks were brushed for 15 sec with a dentifrice slurry after the second and third erosive challenges. Ten volunteers took part in study 1 (S1), where the dentifrices evaluated contained 1100 ppm fluoride as NaF, 0.61% green tea extract, or 0.012% chlorhexidine digluconate. Thirteen volunteers participated in study 2 (S2), in which the treatment was performed only once (1 min) with gels containing 400 μM EGCG (EGCG400), 0.012% chlorhexidine, 1 mM FeSO 4 , 1.23% F (NaF), placebo, or received no treatment. Dentine loss was analyzed by profilometry (μm).
RESULTS


Regarding S1, ERO+ABR induced significantly higher dentine loss compared with ERO and all dentifrices tested led to significantly lower dentine loss when compared with placebo. For S2, regardless of the conditions or times of evaluation, gels containing EGCG, CHX, or FeSO 4  led to significantly less wear compared with the other groups.
CONCLUSION


Both dentifrices and gels containing MMP inhibitors significantly reduced dentine loss.
CLINICAL RELEVANCE


Dentifrices and gels containing MMP inhibitors are able to increase the protection against dentine wear, although gels have a better effect when compared with fluoride gel, lasting up to 10 days after a single application.",2020,", ERO+ABR induced significantly higher dentine loss compared with ERO and all dentifrices tested led to significantly lower dentine loss when compared with placebo.","['Thirteen volunteers participated in study 2 (S2', 'Ten volunteers took part in study 1 (S1', 'Acrylic palatal appliances containing bovine dentine blocks']","['chlorhexidine digluconate', 'Dentifrices or gels containing MMP inhibitors', 'dentifrices or gels containing MMP inhibitors', 'placebo', 'gels containing 400 μM EGCG (EGCG400), 0.012% chlorhexidine, 1 mM FeSO 4 , 1.23% F (NaF), placebo, or received no treatment', 'MMP inhibitors']","['Dentine loss', 'erosion (ERO) and erosion associated with abrasion (ERO+ABR', 'dentine loss']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1513016', 'cui_str': 'MMP Inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C4517394', 'cui_str': '0.012'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C2343853', 'cui_str': 'fesoterodine'}, {'cui': 'C4517495', 'cui_str': '1.23'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}]",13.0,0.0385574,", ERO+ABR induced significantly higher dentine loss compared with ERO and all dentifrices tested led to significantly lower dentine loss when compared with placebo.","[{'ForeName': 'Melissa Thiemi', 'Initials': 'MT', 'LastName': 'Kato', 'Affiliation': 'Department of Dentistry, University of Centro Oeste Paulista - FACOPH, 72 Luiz Gimenez Mocegose, Piratininga, SP, Brazil.'}, {'ForeName': 'Angelica Reis', 'Initials': 'AR', 'LastName': 'Hannas', 'Affiliation': 'Department of Oral Biology, Bauru School of Dentistry, University of São Paulo, 9-75 Al. Octávio Pinheiro Brisolla, Bauru, SP, Brazil.'}, {'ForeName': 'Cristiane de Almeida Baldini', 'Initials': 'CAB', 'LastName': 'Cardoso', 'Affiliation': 'Department of Dentistry, Cruzeiro do Sul University, 868 Galvão Bueno, São Paulo, SP, Brazil.'}, {'ForeName': 'Luiza de Paula Silva', 'Initials': 'LPS', 'LastName': 'Cassiano', 'Affiliation': 'Department of Dentistry, Aparício Carvalho University Center, 241 Ararás street, Eldorado, Porto Velho, RO, Brazil.'}, {'ForeName': 'Paula Andery', 'Initials': 'PA', 'LastName': 'Naves', 'Affiliation': 'Department of Dentistry, Cruzeiro do Sul University, 868 Galvão Bueno, São Paulo, SP, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Magalhães', 'Affiliation': 'Department of Oral Biology, Bauru School of Dentistry, University of São Paulo, 9-75 Al. Octávio Pinheiro Brisolla, Bauru, SP, Brazil.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Tjäderhane', 'Affiliation': 'Institute of Dentistry, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Marília Afonso Rabelo', 'Initials': 'MAR', 'LastName': 'Buzalaf', 'Affiliation': 'Department of Oral Biology, Bauru School of Dentistry, University of São Paulo, 9-75 Al. Octávio Pinheiro Brisolla, Bauru, SP, Brazil. mbuzalaf@fob.usp.br.'}]",Clinical oral investigations,['10.1007/s00784-020-03530-y']
2898,32975708,Randomized phase II clinical trial and biomarker analysis of paclitaxel plus epirubicin versus vinorelbine plus epirubicin as neoadjuvant chemotherapy in locally advanced HER2-negative breast cancer with TEKT4 variations.,"PURPOSE


Resistance to paclitaxel remains a major challenge in treating breast cancer. Our preclinical study suggested that TEKT4 germline variations in breast cancer are associated with paclitaxel resistance and increase vinorelbine sensitivity. This clinical trial compared the efficacy of paclitaxel and vinorelbine in breast cancer neoadjuvant chemotherapy.
METHODS


In this open-label, single-center, phase II trial, female patients with human epidermal growth factor receptor 2 (HER2)-negative, stage IIB-IIIC breast cancer harboring TEKT4 germline variations were randomly assigned to the paclitaxel plus epirubicin (PE) or vinorelbine plus epirubicin (NE). The primary endpoint was the pathologic complete response (pCR) rate, and the secondary endpoints were the objective response rate (ORR) and safety. Targeted sequencing of a panel comprising 484 breast-related genes was performed to identify pCR-associated somatic mutations in each group.
RESULTS


91 Patients were assigned to PE (46 patients) or NE (45 patients). NE numerically increased the pCR rate (22.2% versus 8.7%, P = 0.074). The ORRs for NE and PE were 82.2% and 76.1%, respectively. Interestingly, NE (15.4%) showed a significantly higher pCR rate than PE (0%) in the hormone receptor (HR)-positive subgroup (P = 0.044). Both regimens were well tolerated, with grade 3 and 4 toxicities reported at the expected levels. The biomarker analysis showed that UNC13D mutation predicted the pCR rate in NE (P = 0.011).
CONCLUSIONS


Although the primary endpoint was not met, NE might bring clinical benefit to HR-positive patients or patients simultaneously carrying UNC13D mutations.",2020,"NE numerically increased the pCR rate (22.2% versus 8.7%, P = 0.074).","['breast cancer neoadjuvant chemotherapy', 'female patients with human epidermal growth factor receptor 2 (HER2)-negative, stage IIB-IIIC breast cancer harboring TEKT4 germline variations', '91 Patients were assigned to PE (46 patients) or NE (45 patients', 'locally advanced HER2-negative breast cancer with TEKT4 variations']","['paclitaxel plus epirubicin (PE) or vinorelbine plus epirubicin (NE', 'vinorelbine plus epirubicin', 'paclitaxel and vinorelbine', 'paclitaxel', 'paclitaxel plus epirubicin', 'NE']","['pCR rate', 'objective response rate (ORR) and safety', 'pathologic complete response (pCR) rate', 'ORRs for NE and PE', 'tolerated, with grade 3 and 4 toxicities']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",91.0,0.0454224,"NE numerically increased the pCR rate (22.2% versus 8.7%, P = 0.074).","[{'ForeName': 'Yi-Zhou', 'Initials': 'YZ', 'LastName': 'Jiang', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Li-Ping', 'Initials': 'LP', 'LastName': 'Ge', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'He', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Wen-Jia', 'Initials': 'WJ', 'LastName': 'Zuo', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Guang-Yu', 'Initials': 'GY', 'LastName': 'Liu', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Gen-Hong', 'Initials': 'GH', 'LastName': 'Di', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Zhong-Hua', 'Initials': 'ZH', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China. zhonghuawang95@hotmail.com.""}, {'ForeName': 'Ke-Da', 'Initials': 'KD', 'LastName': 'Yu', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China. yukeda@163.com.""}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Shao', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai, 200032, People's Republic of China. zhimingshao@yahoo.com.""}]",Breast cancer research and treatment,['10.1007/s10549-020-05940-8']
2899,32975739,"Changes in Bone Turnover, Inflammatory, Oxidative Stress, and Metabolic Markers in Women Consuming Iron plus Vitamin D Supplements: a Randomized Clinical Trial.","We aimed to investigate whether combination of vitamin D and iron supplementation, comparing vitamin D alone, could modify bone turnover, inflammatory, oxidative stress, and metabolic markers. Eighty-seven women with hemoglobin (Hb) ≤ 12.7 g/dL and 25OHD ≤ 29 ng/mL vitamin D deficiency/insufficiency aged 18-45 years were randomly assigned into two groups: (1) receiving either 1000 IU/day vitamin D3 plus 27 mg/day iron (D-Fe); (2) vitamin D3 plus placebo supplements (D-P), for 12 weeks. In D-Fe group, significant decrease in red blood cells (RBC) (P = 0.001) and hematocrit (Hct) (P = 0.004) and increases in mean corpuscular hemoglobin concentration (MCHC) (P = 0.001), 25OHD (P < 0.001), osteocalcin (P < 0.001), high-density cholesterol (HDL) (P = 0.041), and fasting blood sugar (FBS) (P < 0.001) were observed. D-P group showed significant decrease in RBC (P < 0.001), Hb (P < 0.001), Hct (P < 0.001), mean corpuscular volume (MCV) (P = 0.004), mean corpuscular hemoglobin (MCH) (P < 0.001), MCHC (P = 0.005), serum ferritin (P < 0.001), and low-density cholesterol (LDL) (P = 0.016) and increases of 25OHD (P < 0.001), osteocalcin (P < 0.001), C-terminal telopeptide (CTX) (P = 0.025), triglyceride (TG) (P = 0.004), FBS (P < 0.001), and interleukin-6 (IL-6) (P = 0.001) at week 12. After the intervention, the D-P group had between-group increases in mean change in the osteocalcin (P = 0.007) and IL-6 (P = 0.033), and decreases in the RBC (P < 0.001), Hb (P < 0.001), Hct (P < 0.001), and MCV (P = 0.001), compared with the D-Fe group. There were significant between-group changes in MCH (P < 0.001), MCHC (P < 0.001), ferritin (P < 0.001), and serum iron (P = 0.018). Iron-vitamin D co-supplementation does not yield added benefits for improvement of bone turnover, inflammatory, oxidative stress, and metabolic markers, whereas, vitamin D alone may have some detrimental effects on inflammatory and metabolic markers. IRCT registration number: IRCT201409082365N9.",2020,"Iron-vitamin D co-supplementation does not yield added benefits for improvement of bone turnover, inflammatory, oxidative stress, and metabolic markers, whereas, vitamin D alone may have some detrimental effects on inflammatory and metabolic markers.","['Women', 'D deficiency/insufficiency aged 18-45 years', 'Eighty-seven women with hemoglobin (Hb']","['vitamin D and iron supplementation, comparing vitamin D alone', 'Iron-vitamin D co-supplementation', 'Consuming Iron plus Vitamin D Supplements', 'dL and 25OHD ≤ 29 ng/mL vitamin', 'vitamin D3 plus 27 mg/day iron (D-Fe); (2) vitamin D3 plus placebo']","['MCV', 'triglyceride (TG', 'interleukin-6 (IL-6', 'fasting blood sugar (FBS', 'red blood cells (RBC', 'mean corpuscular hemoglobin (MCH', 'mean change in the osteocalcin', 'bone turnover, inflammatory, oxidative stress, and metabolic markers', 'osteocalcin', 'FBS', 'C-terminal telopeptide (CTX', 'RBC', 'mean corpuscular hemoglobin concentration (MCHC', 'MCHC', 'Bone Turnover, Inflammatory, Oxidative Stress, and Metabolic Markers', 'mean corpuscular volume (MCV', 'hematocrit (Hct', 'MCH', 'high-density cholesterol (HDL', 'low-density cholesterol (LDL', 'IL-6', 'serum ferritin', '25OHD', 'ferritin']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0524587', 'cui_str': 'Mean cell volume - finding'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0369183', 'cui_str': 'Mean corpuscular hemoglobin determination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0474535', 'cui_str': 'Mean corpuscular hemoglobin concentration determination'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}]",87.0,0.366264,"Iron-vitamin D co-supplementation does not yield added benefits for improvement of bone turnover, inflammatory, oxidative stress, and metabolic markers, whereas, vitamin D alone may have some detrimental effects on inflammatory and metabolic markers.","[{'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Department of Nutrition, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, P.O.BOX: 1449614535, Iran. vafa.m@iums.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Azizi-Soleiman', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Safavi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Seyyed Morteza', 'Initials': 'SM', 'LastName': 'Kazemi', 'Affiliation': 'Bone, Joint, and Related Tissue Research Center, Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zaeri', 'Affiliation': 'Department of Biostatistics, Faculty of Paramedical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Sadeghi', 'Affiliation': ""School of Public Health, Department of Nutrition and Food Science, Texas Woman's University, Denton Campus, Denton, TX, 76204, USA.""}]",Biological trace element research,['10.1007/s12011-020-02400-8']
2900,32975783,Effect of ultrafiltration profiling on outcomes among maintenance hemodialysis patients: a pilot randomized crossover trial.,"BACKGROUND


More rapid fluid removal during hemodialysis is associated with adverse cardiovascular outcomes and longer dialysis recovery times. The effect of ultrafiltration (UF) profiling, independent of concomitant sodium profiling, on markers of intradialytic hemodynamics and other outcomes has been inadequately studied.
METHODS


Four-phase, blinded crossover trial. Participants (UF rates > 10 mL/h/kg) were assigned in random order to receive hemodialysis with UF profiling (constantly declining UF rate, intervention) vs. hemodialysis with conventional UF (control). Each 3-week 9-treatment period was followed by a 1-week 3-treatment washout period. Participants crossed into each study arm twice (2 phases/arm); 18 treatments per treatment type. The primary outcomes were intradialytic hypotension, pre- to post-dialysis troponin T change, and change from baseline in left ventricular global longitudinal strain. Other outcomes included intradialytic symptoms and blood volume measured-plasma refill (post-dialysis volume status measure), among others. Each participant served as their own control.
RESULTS


On average, the 34 randomized patients (mean age 56 years, 24% female, mean dialysis vintage 6.3 years) had UF rates > 10 mL/h/kg in 56% of treatments during the screening period. All but 2 patients completed the 15-week study (prolonged hospitalization, kidney transplant). There was no significant difference in intradialytic hypotension, troponin T change, or left ventricular strain between hemodialysis with UF profiling and conventional UF. With UF profiling, participants had significantly lower odds of light-headedness and plasma refill compared to hemodialysis with conventional UF.
CONCLUSIONS


Ultrafiltration (UF) profiling did not reduce the odds of treatment-related cardiac stress but did reduce the odds of light-headedness and post-dialysis hypervolemia.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03301740 (registered October 4, 2017).",2020,"There was no significant difference in intradialytic hypotension, troponin T change, or left ventricular strain between hemodialysis with UF profiling and conventional UF.","['34 randomized patients (mean age 56\xa0years, 24% female, mean dialysis vintage 6.3\xa0years) had UF rates\u2009>\u200910\xa0mL/h/kg in 56% of treatments during the screening period', 'Participants (UF rates\u2009>\u200910\xa0mL/h/kg', 'maintenance hemodialysis patients']","['Ultrafiltration (UF', 'hemodialysis with UF profiling (constantly declining UF rate, intervention) vs. hemodialysis with conventional UF (control', 'ultrafiltration profiling', 'ultrafiltration (UF']","['intradialytic hypotension, troponin T change, or left ventricular strain', 'intradialytic hypotension, pre- to post-dialysis troponin T change, and change from baseline in left ventricular global longitudinal strain', 'light-headedness and plasma refill', '15-week study (prolonged hospitalization, kidney transplant', 'intradialytic symptoms and blood volume measured-plasma refill']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0439391', 'cui_str': 'mL/h'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1264635', 'cui_str': 'Post-dialysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0220870', 'cui_str': 'Lightheadedness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.294154,"There was no significant difference in intradialytic hypotension, troponin T change, or left ventricular strain between hemodialysis with UF profiling and conventional UF.","[{'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Flythe', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina (UNC) Kidney Center, UNC School of Medicine, 7024 Burnett-Womack CB #7155, Chapel Hill, NC, 27599-7155, USA. jflythe@med.unc.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Tugman', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina (UNC) Kidney Center, UNC School of Medicine, 7024 Burnett-Womack CB #7155, Chapel Hill, NC, 27599-7155, USA.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Narendra', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina (UNC) Kidney Center, UNC School of Medicine, 7024 Burnett-Womack CB #7155, Chapel Hill, NC, 27599-7155, USA.'}, {'ForeName': 'Magdalene M', 'Initials': 'MM', 'LastName': 'Assimon', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of North Carolina (UNC) Kidney Center, UNC School of Medicine, 7024 Burnett-Womack CB #7155, Chapel Hill, NC, 27599-7155, USA.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'Yueting', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Brunelli', 'Affiliation': 'DaVita Clinical Research, Needham, MA, USA.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Hinderliter', 'Affiliation': 'Division of Cardiology, Department of Medicine, UNC School of Medicine, Chapel Hill, NC, USA.'}]",Journal of nephrology,['10.1007/s40620-020-00862-6']
2901,32974034,"Feasibility of a progressive protocol of high-intensity interval training for overweight/obese, sedentary African American women: a retrospective analysis.","Background


African American (AA) women have a higher prevalence of obesity and related metabolic dysfunction and lower level of physical activity compared to white counterparts. Determining feasible exercise alternatives for AA women is, therefore, paramount. Time-efficient high-intensity interval training (HIIT) might be particularly suited for AA women who cite time constraints as a frequent barrier to exercise adherence. The purpose of this study was to assess the feasibility of a 14-week progressive HIIT protocol for previously-sedentary overweight/obese AA women.
Methods


Twenty-eight healthy, premenopausal (age, 20-40 yr), sedentary, nondiabetic, overweight/obese AA women volunteered to participate in the randomized controlled clinical trial from which these data were retrospectively analysed. After assessment, participants were randomly allocated to a HIIT group ( n  = 14) or a no-exercise control group. The HIIT intervention consisted of 24-min sessions performed three times per week for 14 weeks during which work-interval intensity (75 to 90% of heart rate reserve; HRR) and duration (30 to 60 s) and work/recovery ratio (1:7 to 1:3) were progressed in four stages. Feasibility was assessed based on adherence (attrition rate), perceptual response (RPE) and success rate, which was calculated based on the degree to which target intensities for work intervals were achieved/maintained.
Results


Five of 14 participants (35%) in the HIIT group dropped out during the intervention. One-way repeated-measures ANOVA revealed a significant difference across stages for success rate ( p  = 0.018) with post-hoc analysis indicating a significant difference between stage 1 and the other stages and stage 4 and the other stages. There was no significant difference in RPE across stages ( p  = 0.057).
Conclusion


Albeit based on a limited number of participants, we found an attrition rate that was higher than what has been reported previously for HIIT (~ 17.6%) when previously-sedentary overweight/obese AA women performed a protocol with work-interval intensity progressed from 75 to 90% HRR during a 14-week intervention. With respect to intensity, the precipitous drop for achievement of the target HR during the fourth stage (weeks 8-14) for those who did complete the protocol implies that it might be advisable to restrict work-interval intensity to < 90% HRR.
Trial registration


ClinicalTrials.gov. (NCT04293367). Registered 03 March 2020 - Retrospectively registered.",2020,One-way repeated-measures ANOVA revealed a significant difference across stages for success rate ( p  = 0.018) with post-hoc analysis indicating a significant difference between stage 1 and the other stages and stage 4 and the other stages.,"['Methods\n\n\nTwenty-eight', 'healthy, premenopausal (age, 20-40\u2009yr), sedentary, nondiabetic, overweight/obese AA women volunteered', '\n\n\nAfrican American (AA) women', 'overweight/obese, sedentary African American women', 'previously-sedentary overweight/obese AA women']","['HIIT group ( n \u2009=\u200914) or a no-exercise control group', 'progressive HIIT protocol', 'progressive protocol of high-intensity interval training', 'Time-efficient high-intensity interval training (HIIT']","['success rate', 'adherence (attrition rate), perceptual response (RPE) and success rate', 'attrition rate']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442799', 'cui_str': 'Efficient'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",28.0,0.0874129,One-way repeated-measures ANOVA revealed a significant difference across stages for success rate ( p  = 0.018) with post-hoc analysis indicating a significant difference between stage 1 and the other stages and stage 4 and the other stages.,"[{'ForeName': 'Avigdor D', 'Initials': 'AD', 'LastName': 'Arad', 'Affiliation': 'Division of Endocrinology, Diabetes and Bone, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY USA.'}, {'ForeName': 'Jeanine B', 'Initials': 'JB', 'LastName': 'Albu', 'Affiliation': 'Division of Endocrinology, Diabetes and Bone, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY USA.'}, {'ForeName': 'Fred J', 'Initials': 'FJ', 'LastName': 'DiMenna', 'Affiliation': 'Division of Endocrinology, Diabetes and Bone, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY USA.'}]","BMC sports science, medicine & rehabilitation",['10.1186/s13102-020-00207-7']
2902,32974043,Assessing the acceptability of a text messaging service and smartphone app to support patient adherence to medications prescribed for high blood pressure: a pilot study.,"Aims and objectives


This paper describes a pilot non-randomised controlled study of a highly tailored 56-day text messaging and smartphone app prototype intervention to increase adherence to anti-hypertensive medication in primary care. The aim of this study was to evaluate the acceptability of the intervention and obtain patients' views about the intervention content, the delivery mode, and the mechanisms by which the intervention supported medication adherence.
Methods


Patients diagnosed with hypertension were invited and recruited to the study via general practice text messages and attended a face to face meeting with a member of the researcher team. Participants were asked to test the text messaging intervention for 28 consecutive days and switch to the smartphone app for 28 more days. Participants completed baseline and follow-up questionnaires and took part in semi-structured telephone interviews. Digital log files captured patients' engagement with the intervention. Participant transcripts were analysed using thematic analysis. Descriptive statistics were used to summarise data from questionnaires and log files. A mixed methods analysis generated data to respond to the research questions.
Results


Seventy-nine patients expressed interest to participate in this study, of whom 23 (64% male, 82% above 60 years old) were registered to take part. With one drop-out, 22 participants tested the text messaging delivery mode (with 20 being interviewed) and four of them (17%) switched to the app (with 3 being interviewed). All participants engaged and interacted with the text messages and app notifications, and all participants found the intervention content and delivery mode acceptable. They also self-reported that the interactive elements of the intervention motivated them to take their medications as prescribed.
Conclusion


This study provides evidence that the digital intervention is acceptable by hypertensive patients recruited in primary care. Future research could usefully investigate its feasibility and effectiveness using rigorous research methods.
Trial registration


ISRCTN12805654.",2020,"All participants engaged and interacted with the text messages and app notifications, and all participants found the intervention content and delivery mode acceptable.","['Patients diagnosed with hypertension were invited and recruited\xa0to the study via general practice text messages and attended a\xa0face to face meeting with a member of\xa0the researcher team', '22 participants tested the text\xa0messaging delivery mode (with 20 being interviewed) and four of them (17%) switched to the app (with 3 being interviewed', 'Seventy-nine patients expressed interest to participate in this study, of whom 23 (64% male, 82% above 60\u2009years old', 'primary care', 'hypertensive patients recruited in primary care']","['digital intervention', 'text\xa0messaging intervention', 'smartphone app prototype intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]",[],22.0,0.0448086,"All participants engaged and interacted with the text messages and app notifications, and all participants found the intervention content and delivery mode acceptable.","[{'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Kassavou', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, Behavioural Science Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Charlotte Emily', 'Initials': 'CE', 'LastName': ""A'Court"", 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, Behavioural Science Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jagmohan', 'Initials': 'J', 'LastName': 'Chauhan', 'Affiliation': 'Department of Computer Science and Technology, Mobile Systems Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'James David', 'Initials': 'JD', 'LastName': 'Brimocombe', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, Behavioural Science Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Debi', 'Initials': 'D', 'LastName': 'Bhattacharya', 'Affiliation': 'School of Pharmacy, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Naughton', 'Affiliation': 'School of Health Science, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hardeman', 'Affiliation': 'School of Health Science, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Mascolo', 'Affiliation': 'Department of Computer Science and Technology, Mobile Systems Group, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Department of Public Health and Primary Care, The Primary Care Unit, Behavioural Science Group, University of Cambridge, Cambridge, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00666-2']
2903,32974044,"Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES): a randomised controlled pilot feasibility trial for low mood in acquired brain injury.","Background


Acquired brain injury (ABI) affects approximately 79.3 million individuals annually and is linked with elevated rates of depression and low mood. Existing methods for treating depression in ABI have shown mixed efficacy. Behavioural activation (BA) is a potentially promising intervention. Its premise is that individuals with low mood avoid planning and engaging in activities due to low expectations of a positive outcome. Consequently, their exposure to positive reinforcement is reduced, exacerbating low mood. BA aims to break this cycle by encouraging activity planning and engagement. It is unknown whether cognitive demands of traditional BA may undermine efficacy in ABI. Here, we assess the feasibility and acceptability of two groups designed to increase activity engagement. In the activity planning group (traditional BA), the importance of meaningful and positive activity will be discussed and participants encouraged to plan/engage in activities in everyday life. The activity engagement group (experiential BA) instead focuses on engagement in positive experiences (crafts, games, discussion)  within  the group. The primary aims are to evaluate the feasibility and acceptability of the two groups in ABI. A secondary aim is to explore relative efficacy of the groups compared to an equivalent period of waitlist controls.
Method


This study outlines a parallel-arm pilot feasibility trial for individuals with low mood and ABI that compares a traditional vs experiential BA group vs waitlist controls. Adults (≥ 18 years) will be recruited from local ABI services and randomised to condition. Feasibility and acceptability will be assessed via recruitment, retention, attendance and participant feedback. Groups will be compared (pre- and post-intervention and 1 month follow-up) by assessing self-reported activity engagement. Secondary outcomes include self-report measures of depression, anxiety, post-traumatic distress related to the ABI, motivation, participation and sense of control over one's life.
Ethics and dissemination


The trial has been approved by the Health Research Authority of the NHS in the UK (East of England-Cambridge Central, REF 18/EE/0305). Results will inform future research on interventions for mood in ABI and be disseminated broadly via peer-reviewed journals, conference presentations and social media.
Trial registration


ClinicalTrials.gov, NCT03874650 pre-results. Protocol version 2.1, March 5, 2019.",2020,This study outlines a parallel-arm pilot feasibility trial for individuals with low mood and ABI that compares a traditional vs experiential BA group vs waitlist controls.,"['individuals with low mood and ABI that compares a traditional vs experiential BA group vs waitlist controls', 'Adults (≥\u200918\u2009years']","['activity engagement group (experiential BA', 'activity planning group (traditional BA']","['Mood, Activity Participation, and Leisure Engagement Satisfaction (MAPLES', 'Feasibility and acceptability', ""self-report measures of depression, anxiety, post-traumatic distress related to the ABI, motivation, participation and sense of control over one's life"", 'Behavioural activation (BA', 'feasibility and acceptability', 'activity engagement']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0330996', 'cui_str': 'Genus Acer'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0021783', 'cui_str': 'External-Internal Control'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",,0.123716,This study outlines a parallel-arm pilot feasibility trial for individuals with low mood and ABI that compares a traditional vs experiential BA group vs waitlist controls.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kusec', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, 15 Chaucer Road, Cambridge, CB2 7EF UK.'}, {'ForeName': 'Fionnuala C', 'Initials': 'FC', 'LastName': 'Murphy', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, 15 Chaucer Road, Cambridge, CB2 7EF UK.'}, {'ForeName': 'Polly V', 'Initials': 'PV', 'LastName': 'Peers', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, 15 Chaucer Road, Cambridge, CB2 7EF UK.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Lawrence', 'Affiliation': 'Evelyn Community Head Injury Services, Cambridgeshire Community Services, Dynamic Health Building, Brookfields Hospital, 351 Mill Road, Cambridge, CB1 3DF UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Cameron', 'Affiliation': 'The National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Trust, Post Box 113, Queen Square, London, WC1N 3BG UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Morton', 'Affiliation': 'Evelyn Community Head Injury Services, Cambridgeshire Community Services, Dynamic Health Building, Brookfields Hospital, 351 Mill Road, Cambridge, CB1 3DF UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bateman', 'Affiliation': 'School of Health and Social Care, University of Essex, Wivenhoe Park, Colchester, CO4 3SQ UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Watson', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, 15 Chaucer Road, Cambridge, CB2 7EF UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Manly', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, 15 Chaucer Road, Cambridge, CB2 7EF UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00660-8']
2904,32974041,Comparison of first-line and second-line use of fingolimod in relapsing MS: The open-label EARLIMS study.,"Background


Treatment of MS often begins with low-efficacy injectable disease-modifying therapy (iDMT).
Objectives


To compare the effect of fingolimod 0.5 mg/day on clinical, MRI, patient-reported, and safety outcomes, in treatment-naïve and previously treated (≥1 iDMT) patients with early MS.
Methods


EARLIMS was a multicentre, open-label, non-randomized, parallel-group phase 3 b/4 study in Australia and Spain. Patients with relapsing-remitting MS, Expanded Disability Status Scale (EDSS) score <4.0, and ≥1-5 years since diagnosis, received daily fingolimod for 48 weeks. The primary endpoint was annualized relapse rate (ARR).
Results


Of 347 patients enrolled at 51 sites (treatment-naïve, 200 [57.6%]; previously treated, 147 [42.4%]), 320 completed the study (treatment-naïve, 184 [92.0%]; previously treated, 136 [92.5%]), but the study remained underpowered (planned enrolment, n = 432). Fingolimod reduced ARR to similar levels in both treatment-naïve (mean ARR [95% confidence interval], 0.21 [0.14, 0.29]) and previously treated groups (0.30 [0.20, 0.41]; p = 0.1668). There were no new safety signals.
Conclusions


Fingolimod appeared equally effective as first- or second-line therapy in relapsing MS. There was a trend for better outcomes with fingolimod in treatment-naïve patients than in those previously treated with >1 iDMT.",2020,"Fingolimod reduced ARR to similar levels in both treatment-naïve (mean ARR [95% confidence interval], 0.21 [0.14, 0.29]) and previously treated groups (0.30 [0.20, 0.41]; p = 0.1668).","[' previously treated, 147 [42.4%]), 320 completed the study (treatment-naïve, 184 [92.0%]; previously treated, 136 [92.5%]), but the study remained underpowered (planned enrolment, n\u2009=\u2009432', 'relapsing MS', '347 patients enrolled at 51 sites (treatment-naïve, 200 [57.6', 'treatment-naïve and previously treated (≥1 iDMT) patients with early MS', 'Patients with relapsing-remitting MS, Expanded Disability Status Scale (EDSS) score <4.0, and ≥1-5\u2009years since diagnosis, received daily fingolimod for 48\u2009weeks']",[],['annualized relapse rate (ARR'],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0439230', 'cui_str': 'week'}]",[],"[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",347.0,0.0426259,"Fingolimod reduced ARR to similar levels in both treatment-naïve (mean ARR [95% confidence interval], 0.21 [0.14, 0.29]) and previously treated groups (0.30 [0.20, 0.41]; p = 0.1668).","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Fernández', 'Affiliation': 'Department of Neurology, Instituto de Investigación Biomédica de Málaga, Hospital Regional Universitario, Málaga, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Izquierdo', 'Affiliation': 'Unidad de Esclerosis Múltiple, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Aguera', 'Affiliation': 'Neurología, Hospital Universitario Reina Sofía - IMIBIC, Córdoba, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ramo', 'Affiliation': 'Departamento de Neurociencias, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': 'Hospital Universitario Nuestra Señora de Candelaria, Tenerife, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Silva', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Novartis Pharmaceuticals Australia, NSW, Australia.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Butzkueven', 'Affiliation': 'MS and Neuroimmunology Unit, Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Chenyu', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Barnett', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Multiple sclerosis journal - experimental, translational and clinical",['10.1177/2055217320957358']
2905,32974752,Comparison of greater curvature and lesser curvature circular-stapled esophagogastrostomy after esophagectomy in patients with esophageal cancer: a prospective randomized controlled trial.,"PURPOSE


Using a circular stapler to create an anastomosis for esophagogastrostomy after esophagectomy is well accepted; however, it remains uncertain if the greater curvature (GC) or lesser curvature (LC) of the gastric conduit is better for the anastomosis. We conducted this prospective study to compare the integrity of esophagogastrostomy between the esophagus and the GC or LC side of the gastric conduit.
METHODS


The subjects of this study were 70 patients who underwent esophagectomy and were randomized to a ""GC"" group and an ""LC"" group (n = 35 each). The primary and secondary end points were anastomotic leakage (AL) and anastomotic stricture (AS), respectively.
RESULTS


The overall AL rate was 22.1%, without a significant difference between the groups. Stump leakage developed in eight of nine patients in the GC group, whereas leakage developed at the esophagogastric anastomosis in five of six patients in the LC group. The rate of stump leakage was significantly higher than that of esophagogastric AL in the GC group. The overall AS rate was 4.4%, with a significant difference between the groups (0% in the GC group vs. 9.1% in the LC group).
CONCLUSIONS


AL rates were comparable in the two groups, but the sites of leakage were significantly different.",2020,"Stump leakage developed in eight of nine patients in the GC group, whereas leakage developed at the esophagogastric anastomosis in five of six patients in the LC group.","['patients with esophageal cancer', '70 patients who underwent']","['greater curvature and lesser curvature circular-stapled esophagogastrostomy after esophagectomy', 'esophagectomy', 'GC"" group and an ""LC']","['anastomotic leakage (AL) and anastomotic stricture (AS), respectively', 'overall AL rate', 'rate of stump leakage', 'overall AS rate', 'Stump leakage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0227223', 'cui_str': 'Structure of greater curvature of stomach'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0192352', 'cui_str': 'Esophagogastrostomy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0677554', 'cui_str': 'Anastomosis - action'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0002690', 'cui_str': 'Amputation stump'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}]",70.0,0.0398644,"Stump leakage developed in eight of nine patients in the GC group, whereas leakage developed at the esophagogastric anastomosis in five of six patients in the LC group.","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan. k-sasaki@m.kufm.kagoshima-u.ac.jp.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Omoto', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Uchikado', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okumura', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Noda', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tsuruda', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Kita', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Arigami', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Mori', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kurahara', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nakajyo', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Chihaya', 'Initials': 'C', 'LastName': 'Koriyama', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Natsugoe', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ohtsuka', 'Affiliation': 'Department of Digestive Surgery, Breast and Thyroid Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan.'}]",Surgery today,['10.1007/s00595-020-02147-8']
2906,32975823,Thermal suit connected to a forced-air warming unit for preventing intraoperative hypothermia: a randomised controlled trial.,"BACKGROUND


Inadvertent intraoperative hypothermia is a common occurrence in surgical patients. A thermal suit is an option for passive insulation. However, active warming is known to be more effective. Therefore, we hypothesised a forced-air warming unit connected to the thermal suit is superior to a commercial forced-air warming blanket and a warming mattress in breast cancer surgery.
METHODS


Forty patients were randomised to this prospective, clinical trial to wear either the thermal suit or conventional hospital clothes under general anaesthesia. The Thermal suit group had a forced-air warming unit set to 38 °C and connected to the legs of the suit. The Hospital clothes group had a lower body blanket set to 38 °C and a warming mattress set to 37 °C. Core temperature was measured with zero-heat-flux sensor. The primary outcome was core temperature on admission to the recovery room.
RESULTS


There was no difference in mean core temperatures at anaesthetic induction (P=0.4) or on admission to the recovery room (P=0.07). One patient in the Thermal suit group (5%) vs. six patients in the Hospital clothes group (32%) suffered from intraoperative hypothermia (P=0.04, 95% CI 1.9 to 49%). Mean skin temperatures were higher in the Thermal suit group during anaesthesia. No burns or skin irritations were reported. Two patients in the Thermal suit group sweated.
CONCLUSIONS


A thermal suit connected to a forced-air warming unit was not superior to a commercial forced-air warming blanket, although the incidence of intraoperative hypothermia was lower in patients treated with a thermal suit.",2020,There was no difference in mean core temperatures at anaesthetic induction (P=0.4) or on admission to the recovery room (P=0.07).,"['Forty patients', 'surgical patients']","['Thermal suit connected to a forced-air warming unit', 'thermal suit or conventional hospital clothes under general anaesthesia']","['mean core temperatures at anaesthetic induction', 'Mean skin temperatures', 'core temperature on admission to the recovery room', 'intraoperative hypothermia', 'No burns or skin irritations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}]",40.0,0.0619649,There was no difference in mean core temperatures at anaesthetic induction (P=0.4) or on admission to the recovery room (P=0.07).,"[{'ForeName': 'Sirkka-Liisa', 'Initials': 'SL', 'LastName': 'Lauronen', 'Affiliation': 'Department of Anaesthesia, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Marja-Tellervo', 'Initials': 'MT', 'LastName': 'Mäkinen', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki, Helsinki University Hospital.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Annila', 'Affiliation': 'Department of Anaesthesia, Tays Hatanpää, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Huhtala', 'Affiliation': 'Tampere University, Faculty of Social Sciences, Tampere, Finland.'}, {'ForeName': 'Arvi', 'Initials': 'A', 'LastName': 'Yli-Hankala', 'Affiliation': 'Department of Anaesthesia, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Maija-Liisa', 'Initials': 'ML', 'LastName': 'Kalliomäki', 'Affiliation': 'Department of Anaesthesia, Tampere University Hospital, Tampere, Finland.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13714']
2907,32975829,Portable gluten sensors: qualitative assessments by adults and adolescents with coeliac disease.,"BACKGROUND


Portable gluten sensors are now commercially available to the public, although there is genuine uncertainty within the medical community over whether they should be used for coeliac disease management. The present study described qualitatively the experience of using a portable gluten sensor for 15 adults and 15 adolescents with coeliac disease participating in a 3-month pilot clinical trial.
METHODS


Participants were 30 individuals, aged 13-70 years, with biopsy-confirmed coeliac disease on a gluten-free diet. All received a portable gluten sensor and were randomised to low, medium, and high numbers of single-use capsules. Open-ended questions addressed likes and dislikes using the portable gluten sensor after 3 months. Major themes were identified and described.
RESULTS


Participants liked that the portable gluten sensor provided extra assurance to check foods presented as gluten-free, the convenient size and portability, the added sense of control, and overall peace-of-mind. Participants disliked having attention drawn to them when using the sensor and feeling as if they were deterring others from eating. Participants also disliked the physical difficulty associated with using the capsules, questionable accuracy and the inability to test fermented foods. Adults were more enthusiastic about the sensor than adolescents.
CONCLUSIONS


Positive and negative experiences may be expected when using commercially available portable gluten sensors to help manage coeliac disease. As future versions of this and other gluten sensors become available, it will be important to investigate the relationship between users' experience with the sensors and long-term outcomes such as mucosal healing and quality of life.",2020,"RESULTS


Participants liked that the portable gluten sensor provided extra assurance to check foods presented as gluten-free, the convenient size and portability, the added sense of control, and overall peace-of-mind.","['15 adults and 15 adolescents with coeliac disease participating in a 3-month pilot clinical trial', 'adults and adolescents with coeliac disease', 'Participants were 30 individuals, aged 13-70\xa0years, with biopsy-confirmed coeliac disease on a gluten-free diet']",['portable gluten sensor'],['mucosal healing and quality of life'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]","[{'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",15.0,0.0266346,"RESULTS


Participants liked that the portable gluten sensor provided extra assurance to check foods presented as gluten-free, the convenient size and portability, the added sense of control, and overall peace-of-mind.","[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Wolf', 'Affiliation': 'Department of Health & Behavior Studies, Program in Nutrition, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vipperman-Cohen', 'Affiliation': 'Department of Health & Behavior Studies, Program in Nutrition, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'P H R', 'Initials': 'PHR', 'LastName': 'Green', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Reilly', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zybert', 'Affiliation': 'Department of Health & Behavior Studies, Program in Nutrition, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12810']
2908,32975835,Pharmacokinetics and pharmacodynamics of lysergic acid diethylamide microdoses in healthy participants.,"""Microdoses"" of lysergic acid diethylamide (LSD) are used recreationally to enhance mood and cognition. Increasing interest has also been seen in developing LSD into a medication. Therefore, we performed a pharmacokinetic-pharmacodynamic study using very low doses of LSD. Single doses of LSD base (5, 10, and 20 µg) and placebo were administered in a double-blind, randomized, placebo-controlled crossover study in 23 healthy participants. Test days were separated by at least 5 days. Plasma levels of LSD and subjective effects were assessed up to 6 h after administration. Pharmacokinetic parameters were determined using compartmental modeling. Concentration-subjective effect relationships were described using pharmacokinetic-pharmacodynamic modeling. Mean (95% confidence interval) maximal LSD concentrations were 151 pg/mL (127-181), 279 pg/mL (243-320), and 500 pg/mL (413-607) after 5, 10, and 20 µg LSD administration, respectively. Maximal concentrations were reached after 1.1 h. The mean elimination half-life was 2.7 h (1.5-6.2). The 5 µg dose of LSD elicited no significant acute subjective effects. The 10 µg dose of LSD significantly increased ratings of ""under the influence"" and ""good drug effect"" compared with placebo. These effects began an average of 1.1 h after 10 µg LSD administration, peaked at 2.5 h, and ended at 5.1 h. The 20 µg dose of LSD significantly increased ratings of ""under the influence,"" ""good drug effects,"" and ""bad drug effects."" LSD concentrations dose-proportionally increased at doses as low as 5-20 µg and decreased with a half-life of 3 h. The threshold dose of LSD base for psychotropic effects was 10 µg.",2020,"The 10 µg dose of LSD significantly increased ratings of ""under the influence"" and ""good drug effect"" compared with placebo.","['23 healthy participants', 'healthy participants']","['lysergic acid diethylamide microdoses', 'placebo', 'lysergic acid diethylamide (LSD', 'LSD']","['Plasma levels of LSD and subjective effects', 'ratings of ""under the influence,"" ""good drug effects,"" and ""bad drug effects', 'mean elimination half-life', 'maximal LSD concentrations', 'acute subjective effects', 'Maximal concentrations', 'ratings of ""under the influence"" and ""good drug effect', 'LSD concentrations dose']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024334', 'cui_str': 'Lysergic acid diethylamide'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",23.0,0.317833,"The 10 µg dose of LSD significantly increased ratings of ""under the influence"" and ""good drug effect"" compared with placebo.","[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Nadia R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, The Netherlands.'}, {'ForeName': 'Natasha L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, The Netherlands.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Dolder', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, The Netherlands.'}, {'ForeName': 'Eef L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, The Netherlands.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Duthaler', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, UK.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, The Netherlands.'}, {'ForeName': 'Kim P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology & Psychopharmacology, Faculty of Psychology & Neuroscience, Maastricht University, The Netherlands.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2057']
2909,32975853,"Increased lipolysis after infusion of acylated ghrelin: a randomized, double-blinded placebo-controlled trial in hypopituitary patients.","CONTEXT


Acylated ghrelin increases growth hormone (GH) and adrenocorticotrophic hormone (ACTH) secretion from the anterior pituitary gland. Additionally, it increases free fatty acid levels independently of GH and ACTH, but the impact of ghrelin on fatty acid turnover has not been determined. This study was designed to test whether acylated ghrelin directly increases the turnover rate of fatty acids.
DESIGN


Eight hypopituitary patients on stable replacement with GH and hydrocortisone were included in a randomized, double-blinded, placebo-controlled crossover study including two study days: (a) infusion of acylated ghrelin and (b) infusion of saline. The study day comprised a basal period (t = 0-120 minutes) and a hyperinsulinaemic-euglycemic clamp period (t = 120-300 minutes). Whole-body lipolysis was estimated at t = 90-120 and t = 270-300 minutes with a palmitate isotope dilution technique.
RESULTS


Infusion of acylated ghrelin resulted in 10 times increased total ghrelin area under the curve (AUC) levels in the basal period and 15 times increased AUC levels in the clamp period compared with saline infusion (P < .001). GH AUC  levels were largely unaffected by ghrelin compared to saline infusion during both the basal and clamp period, but cortisol AUC  levels increased by 15% after ghrelin compared to saline infusion in the basal period (P = .03). Palmitate turnover was increased by 43% in the basal period (difference: 77 (20) µmol/min, P = .01) and unchanged in the clamp period (difference 0.9 (17) µmol/min, P = 1.0) after ghrelin compared to saline infusion.
CONCLUSIONS


Our results support the hypothesis that pharmacological levels of acylated ghrelin directly activate lipolysis at the whole-body level.",2020,"GH AUC  levels were largely unaffected by ghrelin compared to saline infusion during both the basal and clamp period, but cortisol AUC  levels increased by 15% after ghrelin compared to saline infusion in the basal period (P = .03).","['hypopituitary patients', 'Eight hypopituitary patients on stable replacement with GH and']","['hyperinsulinaemic-euglycemic clamp', 'placebo', 'hydrocortisone', 'infusion of acylated ghrelin and (b) infusion of saline']","['growth hormone (GH) and adrenocorticotrophic hormone', 'ACTH) secretion', 'free fatty acid levels', 'Palmitate turnover', 'cortisol AUC  levels', 'GH AUC  levels', 'Whole-body lipolysis', 'AUC levels', 'Increased lipolysis', 'turnover rate of fatty acids', 'total ghrelin area under the curve (AUC) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}]",8.0,0.273124,"GH AUC  levels were largely unaffected by ghrelin compared to saline infusion during both the basal and clamp period, but cortisol AUC  levels increased by 15% after ghrelin compared to saline infusion in the basal period (P = .03).","[{'ForeName': 'Esben Stistrup', 'Initials': 'ES', 'LastName': 'Lauritzen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens Otto Lunde', 'Initials': 'JOL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Esben Thyssen', 'Initials': 'ET', 'LastName': 'Vestergaard', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}]",Clinical endocrinology,['10.1111/cen.14290']
2910,32970574,Point-of-sale Naloxone: Novel Community-based Research to Identify Naloxone Availability.,"INTRODUCTION


Expanding naloxone availability is important to reduce opioid-related deaths. Recent data suggest low, variable urban naloxone availability. No reports describe naloxone availability at the point of sale (POSN). We characterize POSN without prescription across a Midwestern metropolitan area, via a unique poison center-based study.
METHODS


Pharmacies were randomly sampled within a seven-county metropolitan area, geospatially mapped, and distributed among seven investigators, who visited pharmacies and asked, ""May I purchase naloxone here without a prescription from my doctor?"" Following ""No,"" investigators asked, ""Are you aware of the state statute that allows you to dispense naloxone to the public under a standing order?"" Materials describing statutory support for POSN were provided. Responses were uploaded to REDCap in real time. We excluded specialty (veterinary, mail order, or infusion) pharmacies a priori. POSN availability is presented as descriptive statistics; characteristics of individual sites associated with POSN availability are reported.
RESULTS


In total, 150 pharmacies were prospectively randomized, with 52 subsequently excluded or unavailable for survey. Thus, 98 were included in the final analysis. POSN was available at 71 (72.5%) of 98 pharmacies. POSN availability was more likely at chain than independent pharmacies (84.7% vs 38.5%, p<0.001); rural areas were more commonly served by independent than chain pharmacies (47.4% vs 21.5%, p = 0.022). Five chain and five independent pharmacies (18.5% each) were unaware of state statutory support for collaborative POSN agreements. Statutory awareness was similar between independent and chain pharmacies (68.8% vs 54.6%, p = 0.453). Rationale for no POSN varied.
CONCLUSION


POSN is widely available in this metropolitan area. Variability exists between chain and independent pharmacies, and among pharmacies of the same chain; awareness of statutory guidance does not. Poison centers can act to define local POSN availability via direct inquiry in their communities.",2020,"Statutory awareness was similar between independent and chain pharmacies (68.8% vs 54.6%, p = 0.453).","['In total, 150 pharmacies were prospectively randomized, with 52 subsequently excluded or unavailable for survey', 'Pharmacies were randomly sampled within a seven-county metropolitan area, geospatially mapped, and distributed among seven investigators, who visited pharmacies and asked, ""May I purchase', 'Midwestern metropolitan area, via a unique poison center-based study']","['Naloxone', 'naloxone here without a prescription from my doctor']","['POSN availability', 'Statutory awareness']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0686905', 'cui_str': 'Unavailability'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0032346', 'cui_str': 'Toxic substance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",150.0,0.0373328,"Statutory awareness was similar between independent and chain pharmacies (68.8% vs 54.6%, p = 0.453).","[{'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Olives', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Willhite', 'Affiliation': 'Hennepin Healthcare, Minneapolis, Minnesota.'}, {'ForeName': 'Samantha C', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Minnesota Poison Control System, Minneapolis, Minnesota.'}, {'ForeName': 'Danika K', 'Initials': 'DK', 'LastName': 'Evans', 'Affiliation': 'Hennepin Healthcare, Department of Emergency Medicine, Minneapolis, Minnesota.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Jensen', 'Affiliation': 'Minnesota Poison Control System, Minneapolis, Minnesota.'}, {'ForeName': 'Hsiao-Ting', 'Initials': 'HT', 'LastName': 'Regelman', 'Affiliation': 'Minnesota Poison Control System, Minneapolis, Minnesota.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'McGillis', 'Affiliation': 'University of Calgary, Department of Emergency Medicine, Calgary, Alberta, Canada.'}]",The western journal of emergency medicine,['10.5811/westjem.7.2020.47252']
2911,32970583,Creation and Implementation of a Mastery Learning Curriculum for Emergency Department Thoracotomy.,"INTRODUCTION


Emergency department thoracotomy (EDT) is a lifesaving procedure within the scope of practice of emergency physicians. Because EDT is infrequently performed, emergency medicine (EM) residents lack opportunities to develop procedural competency. There is no current mastery learning curriculum for residents to learn EDT. The purpose of this study was to develop and implement a simulation-based mastery learning curriculum to teach and assess EM residents' performance of the EDT.
METHODS


We developed an EDT curriculum using a mastery learning framework. The minimum passing standard (MPS) for a previously developed 22-item checklist was determined using the Mastery Angoff approach. EM residents at a four-year academic EM residency program underwent baseline testing in performing an EDT on a simulation trainer. Performance was scored by two raters using the checklist. Learners then participated in a novel mastery learning EDT curriculum that included an educational video, hands-on instruction, and deliberate practice. After a three-month period, residents then completed initial post testing. Residents who did not meet the minimum passing standard after post testing participated in additional deliberate practice until mastery was obtained. Baseline and post-test scores, and time to completion of the procedure were compared with paired t-tests.
RESULTS


Of 56 eligible EM residents, 54 completed baseline testing. Fifty-two residents completed post-testing until mastery was reached. The minimum passing standard was 91.1%, (21/22 items correct on the checklist). No participants met the MPS at the baseline assessment. After completion of the curriculum, all residents subsequently reached the MPS, with deliberate practice sessions not exceeding 40 minutes. Scores from baseline testing to post-testing significantly improved across all postgraduate years from a mean score of 10.2/22 to 21.4/22 (p <0.001). Mean time to complete the procedure improved from baseline testing (6 minutes [min] and 21 seconds [sec], interquartile range [IQR] = 4 min 54 sec - 7 min 51 sec) to post-testing (5 min 19 seconds, interquartile range 4 min 17sec - 6 min 15 sec; p = 0.001).
CONCLUSION


This simulation-based mastery learning curriculum resulted in all residents performing an EDT at a level that met or exceeded the MPS with an overall decrease in time needed to perform the procedure.",2020,"Mean time to complete the procedure improved from baseline testing (6 minutes [min] and 21 seconds [sec], interquartile range [IQR] = 4 min 54 sec - 7 min 51 sec) to post-testing (5 min 19 seconds, interquartile range 4 min 17sec - 6 min 15 sec; p = 0.001).
","['EM residents at a four-year academic EM residency program underwent baseline testing in performing an EDT on a simulation trainer', 'Of 56 eligible EM residents, 54 completed baseline testing', 'Emergency Department Thoracotomy']","['Emergency department thoracotomy (EDT', 'Mastery Learning Curriculum']","['Mean time', 'Baseline and post-test scores, and time to completion of the procedure']","[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",56.0,0.0707255,"Mean time to complete the procedure improved from baseline testing (6 minutes [min] and 21 seconds [sec], interquartile range [IQR] = 4 min 54 sec - 7 min 51 sec) to post-testing (5 min 19 seconds, interquartile range 4 min 17sec - 6 min 15 sec; p = 0.001).
","[{'ForeName': 'Danielle T', 'Initials': 'DT', 'LastName': 'Miller', 'Affiliation': 'Stanford University School of Medicine, Department of Emergency Medicine, Palo Alto, California.'}, {'ForeName': 'Hashim Q', 'Initials': 'HQ', 'LastName': 'Zaidi', 'Affiliation': 'University of Chicago School of Medicine, Department of Emergency Medicine, Chicago, Illinois.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Sista', 'Affiliation': 'Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, Tennessee.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Dhake', 'Affiliation': 'NorthShore University Health System, Department of Emergency Medicine, Chicago, Illinois.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Pirotte', 'Affiliation': 'Vanderbilt University School of Medicine, Department of Emergency Medicine, Nashville, Tennessee.'}, {'ForeName': 'Abra L', 'Initials': 'AL', 'LastName': 'Fant', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Department of Emergency Medicine, Chicago, Illinois.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Salzman', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Department of Emergency Medicine, Chicago, Illinois.'}]",The western journal of emergency medicine,['10.5811/westjem.2020.5.46207']
2912,32970697,"Acceptability of a trial of vaginal progesterone for the prevention of preterm birth among HIV-infected women in Lusaka, Zambia: A mixed methods study.","Antenatal progesterone prevents preterm birth (PTB) in women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively. Neither has been tested for the indication of maternal HIV, which is associated with an elevated risk of PTB. The Vaginal Progesterone (VP) Trial was a pilot feasibility study of VP to prevent HIV-related PTB in Lusaka, Zambia. Using mixed methods, we concurrently evaluated the acceptability of the trial and the study product among participants. Over a 1-year period, we enrolled 140 pregnant women living with HIV into a double-masked, placebo-controlled, randomized trial of daily self-administered VP or placebo. We administered an endline questionnaire to all participants and conducted in-depth interviews with 30 participants to assess barriers and facilitators to uptake and retention in the trial and to study product adherence. All interviews were audiotaped, transcribed, translated into English as needed, and independently coded by two analysts to capture emerging themes. Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product. When given a hypothetical choice between vaginal and injectable progesterone, 97 (74%) chose vaginal, 31 (24%) injectable, and 3 (2%) stated no preference. Most interviewees reported no difficulties with using the study product; others cited minor side effects and surmountable challenges. Strategies that supported adherence included setting alarms, aligning dosing with antiretrovirals, receiving encouragement from friends and family, sensing a benefit to their unborn baby, and positive feedback from study staff. Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit. Those who would prefer weekly injections cited fewer doses to remember. Perceived barriers to study participation included mistrust about the motivations behind research, suspicion of Satanism, and futility or possible harm from a placebo. We report key influences on acceptability of a randomized trial of VP to prevent PTB among HIV-infected women in Zambia, which should inform methods to promote uptake, adherence, and retention in a full-scale trial.",2020,"Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product.","['women with a short cervix or prior PTB in daily vaginal or weekly injectable formulations, respectively', '140 pregnant women living with HIV into a double-masked', 'preterm birth among HIV-infected women in Lusaka, Zambia', '131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product', 'Participants who reported preference of a vaginal medication over injectable described familiarity with the vaginal product, a fear of needles and resulting pain, and inconvenience of a weekly clinic visit', 'HIV-infected women in Zambia']","['vaginal progesterone', 'Antenatal progesterone', 'placebo', 'VP', 'daily self-administered VP or placebo']",['preterm birth (PTB'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C3205661', 'cui_str': 'Vaginal Product'}, {'cui': 'C0424187', 'cui_str': 'Fear of needles'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",140.0,0.29868,"Of 131 participants who completed the questionnaire, 128 (98%) reported that nothing was difficult when asked the hardest part about using the study product.","[{'ForeName': 'Joan T', 'Initials': 'JT', 'LastName': 'Price', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.""}, {'ForeName': 'Chileshe M', 'Initials': 'CM', 'LastName': 'Mabula-Bwalya', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bethany L', 'Initials': 'BL', 'LastName': 'Freeman', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Carda-Auten', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Winifreda M', 'Initials': 'WM', 'LastName': 'Phiri', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Kasapo', 'Initials': 'K', 'LastName': 'Chibwe', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kantumoya', 'Affiliation': 'UNC Global Projects - Zambia, Lusaka, Zambia.'}, {'ForeName': 'Bellington', 'Initials': 'B', 'LastName': 'Vwalika', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': ""Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.""}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Golin', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0238748']
2913,32970730,"Test but not treat: Community members' experiences with barriers and facilitators to universal antiretroviral therapy uptake in rural KwaZulu-Natal, South Africa.","INTRODUCTION


Antiretroviral therapy (ART) has revolutionised the care of HIV-positive individuals resulting in marked decreases in morbidity and mortality, and markedly reduced transmission to sexual partners. However, these benefits can only be realised if individuals are aware of their HIV-positive status, initiated and retained on suppressive lifelong ART. Framed using the socio-ecological model, the present study explores factors contributing to poor ART uptake among community members despite high acceptance of HIV-testing within a Treatment as Prevention (TasP) trial. In this paper we identify barriers and facilitators to treatment across different levels of the socio-ecological framework covering individual, community and health system components.
METHODS


This research was embedded within a cluster-randomised trial (ClinicalTrials.gov, number NCT01509508) of HIV treatment as Prevention in rural KwaZulu-Natal, South Africa. Data were collected between January 2013 and July 2014 from resident community members. Ten participants contributed to repeat in-depth interviews whilst 42 participants took part in repeat focus group discussions. Data from individual interviews and focus group discussions were triangulated using community walks to give insights into community members' perception of the barriers and facilitators of ART uptake. We used thematic analysis guided by a socio-ecological framework to analyse participants' narratives from both individual interviews and focus group discussions.
RESULTS


Barriers and facilitators operating at the individual, community and health system levels influence ART uptake. Stigma was an over-arching barrier, across all three levels and expressed variably as fear of HIV disclosure, concerns about segregated HIV clinical services and negative community religious perceptions. Other barriers were individual (substance misuse, fear of ART side effects), community (alternative health beliefs). Facilitators cited by participants included individual (expectations of improved health and longer life expectancy following ART, single tablet regimens), community (availability of ART in the community through mobile trial facilities) and health system factors (fast and efficient service provided by friendly staff).
DISCUSSION


We identified multiple barriers to achieving universal ART uptake. To enhance uptake in HIV care services, and achieve the full benefits of ART requires interventions that tackle persistent HIV stigma, and offer people with HIV respectful, convenient and efficient services. These interventions require evaluation in appropriately designed studies.",2020,"Stigma was an over-arching barrier, across all three levels and expressed variably as fear of HIV disclosure, concerns about segregated HIV clinical services and negative community religious perceptions.","['Data were collected between January 2013 and July 2014 from resident community members', 'rural KwaZulu-Natal, South Africa']",['Antiretroviral therapy (ART'],['morbidity and mortality'],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",42.0,0.134278,"Stigma was an over-arching barrier, across all three levels and expressed variably as fear of HIV disclosure, concerns about segregated HIV clinical services and negative community religious perceptions.","[{'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Iwuji', 'Affiliation': 'Department of Global Health and Infection, Brighton and Sussex Medical School, University of Sussex, Falmer, United Kingdom.'}, {'ForeName': 'Rujeko Samanthia', 'Initials': 'RS', 'LastName': 'Chimukuche', 'Affiliation': 'Africa Health Research Institute, Berea, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Thembelihle', 'Initials': 'T', 'LastName': 'Zuma', 'Affiliation': 'Africa Health Research Institute, Berea, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Plazy', 'Affiliation': 'Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, Bordeaux, France.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Larmarange', 'Affiliation': 'Institut de Recherche pour le Développement(IRD), Centre Population et Développement (Ceped), Paris, France.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Orne-Gliemann', 'Affiliation': 'Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, Bordeaux, France.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Siedner', 'Affiliation': 'Africa Health Research Institute, Berea, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Africa Health Research Institute, Berea, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Africa Health Research Institute, Berea, KwaZulu-Natal, South Africa.'}]",PloS one,['10.1371/journal.pone.0239513']
2914,32970784,A randomised trial of social support group intervention for people with aphasia: A Novel application of virtual reality.,"About a third of strokes cause aphasia, or language loss, with profound consequences for the person's social participation and quality of life. These problems may be mitigated by group social support. But this intervention is not available to all individuals. This study investigated whether it is feasible to deliver group social support to people with aphasia via a multi-user, virtual reality platform. It also explored the indicative effects of intervention and the costs. Intervention aimed to promote wellbeing and communicative success. It enabled participants to form new social connections and share experiences of living with aphasia. It comprised 14 sessions delivered over 6 months and was led by community based co-ordinators and volunteers. Feasibility measures comprised: recruitment and retention rates, compliance with intervention and assessment of treatment fidelity. Effects of intervention were explored using a waitlist randomised controlled design, with outcome measures of wellbeing, communication, social connectedness and quality of life. Two intervention groups were randomised to an immediate condition and two were randomised to a delayed condition. The main analysis explored scores on the measures between two time points, between which those in the immediate condition had received intervention, but those in the delayed group had not (yet). A comprehensive approach to economic data collection ensured that all costs of treatment delivery were recorded. Feasibility findings showed that the recruitment target was met (N = 34) and 85.3% (29/34) of participants completed intervention. All groups ran the 14 sessions as planned, and participants attended a mean of 11.4 sessions (s.d. 2.8), which was 81.6% of the intended dose. Fidelity checking showed minimal drift from the manualised intervention. No significant change was observed on any of the outcome measures, although the study was not powered to detect these. Costs varied across the four groups, from £7,483 - £12,562 British Pounds Sterling ($10,972 - $18,419 US dollars), depending on travel costs, the relative contributions of volunteers and the number of hardware loans that were needed. The results suggest that a larger trial of remote group support, using virtual reality, would be merited. However the treatment content and regime, and the selection of outcome measures should be reviewed before conducting the trial. Trail registration: Study registered with ClinicalTrials.gov; Identifier: https://www.ncbi.nlm.nih.gov/NCT03115268.",2020,"Costs varied across the four groups, from £7,483 - £12,562 British Pounds Sterling ($10,972 - $18,419 US dollars), depending on travel costs, the relative contributions of volunteers and the number of hardware loans that were needed.",['people with aphasia'],['social support group intervention'],"['recruitment and retention rates, compliance with intervention and assessment of treatment fidelity', 'wellbeing, communication, social connectedness and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}]","[{'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0650251,"Costs varied across the four groups, from £7,483 - £12,562 British Pounds Sterling ($10,972 - $18,419 US dollars), depending on travel costs, the relative contributions of volunteers and the number of hardware loans that were needed.","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Devane', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Talbot', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Caute', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Cruice', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Hilari', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'MacKenzie', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Maguire', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Anita Patel Health Economics Consulting Ltd, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Abi', 'Initials': 'A', 'LastName': 'Roper', 'Affiliation': 'Centre for Language and Communication Science Research, City, University of London, London, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wilson', 'Affiliation': 'Centre for Human Computer Interaction Design, City, University of London, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0239715']
2915,32970970,Factors influencing thigh muscle volume change with cycling exercises in acute spinal cord injury - a secondary analysis of a randomized controlled trial.,"Objective:  To conduct a per-protocol analysis on thigh muscle volume outcomes from the Spinal Cord Injury and Physical Activity (SCIPA) Switch-On Trial.  Design:  Secondary analysis from an assessor-blind randomized, controlled trial.  Setting:  Four acute/sub-acute hospitals in Australia and New Zealand.  Participants:  24 adults (1 female) within four weeks of motor complete or incomplete spinal cord injury (SCI)  Intervention:  Functional electrical stimulation-assisted cycling (FESC) or passive cycling (PC) 4x/week for 12 weeks.  Outcome Measures:  Whole thigh and muscle group volumes calculated from manually segmented MR images.  Results:  19/24 participants completed ≥ twelve weeks of the intervention. Five participants experienced hypertrophy (4 FESC; 1 PC) and eight attenuation of atrophy (<20% volume loss) (3 FESC; 5 PC) in thigh muscle volume. Six participants were non-responders, exhibiting atrophy >20% (3 FESC; 3 PC). Mean (SD) change for FESC was -2.3% (25.3%) and PC was -14.0% (12.3%). After controlling for baseline muscle volumes, a strong significant correlation was found between mean weekly exercise frequency and quadriceps and hamstring volumes (r=6.25, P=0.006), regardless of mode. Average watts was highly correlated to quadriceps volumes only (r=5.92, P=0.01), while total number of sessions was strongly correlated with hamstring volumes only (r=5.91, P=0.01).  Conclusion:  This per-protocol analysis of FESC and PC early after SCI reports a partial response in 42% and a beneficial response in 25% of patients who completed 12 weeks intervention, regardless of mode. Strong correlations show a dose-response according to exercise frequency. Characteristics of non-responders are discussed to inform clinical decision-making.",2020,"Average watts was highly correlated to quadriceps volumes only (r=5.92, P=0.01), while total number of sessions was strongly correlated with hamstring volumes only (r=5.91, P=0.01).  ","['Participants:  24 adults (1 female) within four weeks of', 'acute spinal cord injury ', 'Setting:  Four acute/sub-acute hospitals in Australia and New Zealand']","['Spinal Cord Injury and Physical Activity (SCIPA', 'motor complete or incomplete spinal cord injury (SCI)  Intervention:  Functional electrical stimulation-assisted cycling (FESC) or passive cycling (PC) 4x', 'cycling exercises']","['total number of sessions', 'quadriceps volumes', 'mean weekly exercise frequency and quadriceps and hamstring volumes', 'Mean (SD) change for FESC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0556455', 'cui_str': 'Frequency of exercise'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",6.0,0.337027,"Average watts was highly correlated to quadriceps volumes only (r=5.92, P=0.01), while total number of sessions was strongly correlated with hamstring volumes only (r=5.91, P=0.01).  ","[{'ForeName': 'Maya G', 'Initials': 'MG', 'LastName': 'Panisset', 'Affiliation': 'Department of Medicine (Royal Melbourne Hospital), University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Doa', 'Initials': 'D', 'LastName': 'El-Ansary', 'Affiliation': 'Department of Nursing and Allied Health, Swinburne University of Technology, Hawthorne, Australia.'}, {'ForeName': 'Sarah Alison', 'Initials': 'SA', 'LastName': 'Dunlop', 'Affiliation': 'School of Biological Sciences, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Marshall', 'Affiliation': 'Hampstead Rehabilitation Centre, Northfield, Australia.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Clark', 'Affiliation': 'Hampstead Rehabilitation Centre, Lightsview, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Galea', 'Affiliation': 'Department of Medicine (Royal Melbourne Hospital), University of Melbourne, Parkville, Australia.'}]",The journal of spinal cord medicine,['10.1080/10790268.2020.1815480']
2916,32971005,"Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial.","BACKGROUND


Survival outcomes are poor for patients with metastatic urothelial carcinoma who receive standard, first-line, platinum-based chemotherapy. We assessed the overall survival of patients who received durvalumab (a PD-L1 inhibitor), with or without tremelimumab (a CTLA-4 inhibitor), as a first-line treatment for metastatic urothelial carcinoma.
METHODS


DANUBE is an open-label, randomised, controlled, phase 3 trial in patients with untreated, unresectable, locally advanced or metastatic urothelial carcinoma, conducted at 224 academic research centres, hospitals, and oncology clinics in 23 countries. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1. We randomly assigned patients (1:1:1) to receive durvalumab monotherapy (1500 mg) administered intravenously every 4 weeks; durvalumab (1500 mg) plus tremelimumab (75 mg) administered intravenously every 4 weeks for up to four doses, followed by durvalumab maintenance (1500 mg) every 4 weeks; or standard-of-care chemotherapy (gemcitabine plus cisplatin or gemcitabine plus carboplatin, depending on cisplatin eligibility) administered intravenously for up to six cycles. Randomisation was done through an interactive voice-web response system, with stratification by cisplatin eligibility, PD-L1 status, and presence or absence of liver metastases, lung metastases, or both. The coprimary endpoints were overall survival compared between the durvalumab monotherapy versus chemotherapy groups in the population of patients with high PD-L1 expression (the high PD-L1 population) and between the durvalumab plus tremelimumab versus chemotherapy groups in the intention-to-treat population (all randomly assigned patients). The study has completed enrolment and the final analysis of overall survival is reported. The trial is registered with ClinicalTrials.gov, NCT02516241, and the EU Clinical Trials Register, EudraCT number 2015-001633-24.
FINDINGS


Between Nov 24, 2015, and March 21, 2017, we randomly assigned 1032 patients to receive durvalumab (n=346), durvalumab plus tremelimumab (n=342), or chemotherapy (n=344). At data cutoff (Jan 27, 2020), median follow-up for survival was 41·2 months (IQR 37·9-43·2) for all patients. In the high PD-L1 population, median overall survival was 14·4 months (95% CI 10·4-17·3) in the durvalumab monotherapy group (n=209) versus 12·1 months (10·4-15·0) in the chemotherapy group (n=207; hazard ratio 0·89, 95% CI 0·71-1·11; p=0·30). In the intention-to-treat population, median overall survival was 15·1 months (13·1-18·0) in the durvalumab plus tremelimumab group versus 12·1 months (10·9-14·0) in the chemotherapy group (0·85, 95% CI 0·72-1·02; p=0·075). In the safety population, grade 3 or 4 treatment-related adverse events occurred in 47 (14%) of 345 patients in the durvalumab group, 93 (27%) of 340 patients in the durvalumab plus tremelimumab group, and in 188 (60%) of 313 patients in the chemotherapy group. The most common grade 3 or 4 treatment-related adverse event was increased lipase in the durvalumab group (seven [2%] of 345 patients) and in the durvalumab plus tremelimumab group (16 [5%] of 340 patients), and neutropenia in the chemotherapy group (66 [21%] of 313 patients). Serious treatment-related adverse events occurred in 30 (9%) of 345 patients in the durvalumab group, 78 (23%) of 340 patients in the durvalumab plus tremelimumab group, and 50 (16%) of 313 patients in the chemotherapy group. Deaths due to study drug toxicity were reported in two (1%) patients in the durvalumab group (acute hepatic failure and hepatitis), two (1%) patients in the durvalumab plus tremelimumab group (septic shock and pneumonitis), and one (<1%) patient in the chemotherapy group (acute kidney injury).
INTERPRETATION


This study did not meet either of its coprimary endpoints. Further research to identify the patients with previously untreated metastatic urothelial carcinoma who benefit from treatment with immune checkpoint inhibitors, either alone or in combination regimens, is warranted.
FUNDING


AstraZeneca.",2020,"Serious treatment-related adverse events occurred in 30 (9%) of 345 patients in the durvalumab group, 78 (23%) of 340 patients in the durvalumab plus tremelimumab group, and 50 (16%) of 313 patients in the chemotherapy group.","['EudraCT number 2015-001633-24.\nFINDINGS\n\n\nBetween Nov 24, 2015, and March 21, 2017, we randomly assigned 1032 patients to receive', 'previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE', 'patients with metastatic urothelial carcinoma who receive standard, first-line, platinum-based chemotherapy', 'patients with previously untreated metastatic urothelial carcinoma', 'Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1', 'patients with untreated, unresectable, locally advanced or metastatic urothelial carcinoma, conducted at 224 academic research centres, hospitals, and oncology clinics in 23 countries']","['durvalumab (1500 mg) plus tremelimumab', 'durvalumab', 'durvalumab maintenance (1500 mg) every 4 weeks; or standard-of-care chemotherapy (gemcitabine plus cisplatin or gemcitabine plus carboplatin, depending on cisplatin eligibility', 'durvalumab monotherapy', 'durvalumab (a PD-L1 inhibitor), with or without tremelimumab (a CTLA-4 inhibitor', 'Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy', 'durvalumab plus tremelimumab (n=342), or chemotherapy']","['adverse events', 'median overall survival', 'neutropenia', 'median follow-up for survival', 'overall survival', 'adverse event']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",1032.0,0.25074,"Serious treatment-related adverse events occurred in 30 (9%) of 345 patients in the durvalumab group, 78 (23%) of 340 patients in the durvalumab plus tremelimumab group, and 50 (16%) of 313 patients in the chemotherapy group.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK. Electronic address: thomas.powles1@nhs.net.'}, {'ForeName': 'Michiel S', 'Initials': 'MS', 'LastName': 'van der Heijden', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'The Tisch Cancer Institute, Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Loriot', 'Affiliation': 'Institut Gustave Roussy, INSERM U981, University of Paris Saclay, Villejuif, France.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Smilow Cancer Center, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ogawa', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Sungkyunkwan University Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jae-Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bögemann', 'Affiliation': 'Universitätsklinikum Münster, Münster, Germany.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'Alexandra Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Eigl', 'Affiliation': 'BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Clinical Medicine, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Som D', 'Initials': 'SD', 'LastName': 'Mukherjee', 'Affiliation': 'Juravinski Cancer Centre, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Fradet', 'Affiliation': 'Centre Hospitalier Universitaire de Québec-Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Skoneczna', 'Affiliation': ""Saint Elizabeth's Hospital, Mokotów Medical Center, Warsaw, Poland.""}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Tsiatas', 'Affiliation': 'Department of Medical Oncology, Athens Medical Center, Marousi, Greece.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Novikov', 'Affiliation': 'North-Western State Medical University, Saint Petersburg, Russia.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Suárez', 'Affiliation': ""Medical Oncology, Vall d'Hebron Institute of Oncology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.""}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'Fay', 'Affiliation': 'Hospital Sao Lucas da PUCRS/Grupo Oncoclinicas, Porto Alegre, Brazil.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Duran', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Wildsmith', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Angra', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Ashok K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Levin', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'Beth Israel Deaconess Medical Center and PSMAR-IMIM Research Lab, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30541-6']
2917,32971036,Molecular response after obinutuzumab plus high-dose cytarabine induction for transplant-eligible patients with untreated mantle cell lymphoma (LyMa-101): a phase 2 trial of the LYSA group.,"BACKGROUND


Obinutuzumab monotherapy has shown promising efficacy in mantle cell lymphoma. We aimed to investigate the activity of obinutuzumab plus DHAP (dexamethasone, high-dose cytarabine, and cisplatin), measured by minimal residual disease quantitative (q)PCR status in the bone marrow after four cycles.
METHODS


LyMa-101 was a prospective, open-label, single-arm, phase 2 trial. Participants were enrolled from 28 hospitals in France. Newly diagnosed patients with mantle cell lymphoma (aged 18 to <66 years) who were eligible for autologous stem-cell transplantation received four cycles of obinutuzumab plus DHAP (obinutuzumab 1000 mg/m 2  intravenously on days 1, 8, and 15 at cycle 1 and day 1 at cycles 2, 3, and 4; dexamethasone 40 mg intravenously on days 1-4, cytarabine 2 g/m 2  intravenously every 12 h on day 1, and according to local investigator, cisplatin 100 mg/m 2  by continuous infusion over 24 h on day 1 or carboplatin area under the curve 5 or oxaliplatin 130 mg/m 2 ) every 21 days before transplantation, and 3 years of obinutuzumab (1000 mg/m 2  every 2 months) maintenance followed by minimal residual disease-based obinutuzumab on-demand maintenance. The primary outcome was minimal residual disease negativity in the bone marrow after four cycles of obinutuzumab plus DHAP at the end of induction, measured in the efficacy set (all minimal residual disease-informative [bone marrow or peripheral blood] patients who received at least one dose of obinutuzumab). Obinutuzumab plus DHAP was considered effective if bone marrow minimal residual disease negativity was 70% or more by intention to treat. The trial is closed to recruitment and registered with ClinicalTrials.gov, NCT02896582.
FINDINGS


86 patients were enrolled between Nov 29, 2016, and May 2, 2018. 81 patients completed induction, 73 underwent autologous stem-cell transplantation, and 69 started maintenance therapy. 55 (75%) of 73 patients in the efficacy set reached minimal residual disease negativity in bone marrow at end of induction. According to the protocol definition, 18 (25%) of 73 patients in the efficacy set were minimal residual disease-positive: 12 patients who were minimal residual disease-positive in the bone marrow, plus two patients who progressed during induction, and four patients who did not have minimal residual disease assessment. The most common grade 3-4 treatment-emergent adverse events were anaemia (grade 3, 26 [31%] of 85 patients; grade 4, three [4%] of 85 patients) and neutropenia (grade 3, 13 [15%] of 85 patients; grade 4, 32 [38%] of 85 patients). 58 serious adverse events occurred during the induction phase. There were no treatment-related deaths.
INTERPRETATION


Obinutuzumab plus DHAP is a well tolerated regimen and has good activity for inducing minimal residual disease negativity in the bone marrow of transplant-eligible patients with mantle cell lymphoma. Obinutuzumab plus DHAP has potential activity as induction chemotherapy, with bone marrow minimal residual disease negativity potentially predicting long-term disease control.
FUNDING


Roche SAS.",2020,"There were no treatment-related deaths.
","['transplant-eligible patients with untreated mantle cell lymphoma (LyMa-101', 'Newly diagnosed patients with mantle cell lymphoma (aged 18 to <66 years) who were eligible for autologous stem-cell transplantation received four cycles of', '86 patients were enrolled between Nov 29, 2016, and May 2, 2018', '81 patients completed induction, 73 underwent autologous stem-cell transplantation, and 69 started maintenance therapy', 'transplant-eligible patients with mantle cell lymphoma', '73 patients in the efficacy set were minimal residual disease-positive: 12 patients who were minimal residual disease-positive in the bone marrow, plus two patients who progressed during induction, and four patients who did not have minimal residual disease assessment', 'Participants were enrolled from 28 hospitals in France']","['obinutuzumab plus DHAP (obinutuzumab 1000 mg/m 2  intravenously', 'obinutuzumab plus high-dose cytarabine induction', 'obinutuzumab (1000 mg/m 2  every 2 months) maintenance followed by minimal residual disease-based obinutuzumab on-demand maintenance', 'LYSA', 'Obinutuzumab plus DHAP', 'obinutuzumab plus DHAP (dexamethasone, high-dose cytarabine, and cisplatin', 'cisplatin 100 mg/m 2  by continuous infusion over 24 h on day 1 or carboplatin area under the curve 5 or oxaliplatin', 'dexamethasone 40 mg intravenously on days 1-4, cytarabine']","['58 serious adverse events', 'Molecular response', 'neutropenia', 'minimal residual disease negativity in the bone marrow']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0334634', 'cui_str': 'Mantle cell lymphoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012324', 'cui_str': 'Dihydroxyacetone 3-Phosphate'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}]",86.0,0.0468988,"There were no treatment-related deaths.
","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': ""Service d'hématologie clinique, CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes, France. Electronic address: steven.legouill@chu-nantes.fr.""}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Beldi-Ferchiou', 'Affiliation': 'Biological Haematology and Immunology Department, Groupe Hospitalier Mondor, Assistance Publique Hôpitaux de Paris, INSERM U955, Paris, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Alcantara', 'Affiliation': 'Onco-Haematology, Université de Paris, Hôpital and Institut Necker-Enfants Malades, Assistance-Publique-Hôpitaux de Paris, INSERM U1151, Paris, France.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cacheux', 'Affiliation': ""Service d'hématologie clinique du CHU de Clermont-Ferrand, Clermont-Ferrand, France.""}, {'ForeName': 'Violaine', 'Initials': 'V', 'LastName': 'Safar', 'Affiliation': 'Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burroni', 'Affiliation': 'Department of Pathology, Cochin Hospital, Paris, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Guidez', 'Affiliation': ""Service d'hématologie clinique du CHU de Poitiers, Poitiers, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gastinne', 'Affiliation': ""Service d'hématologie clinique, CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes, France.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Canioni', 'Affiliation': 'Onco-Haematology, Université de Paris, Hôpital and Institut Necker-Enfants Malades, Assistance-Publique-Hôpitaux de Paris, INSERM U1151, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': ""Service d'hémato-oncologie, L'hôpital Saint-Louis AP-HP, Université de Paris, Paris, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Maisonneuve', 'Affiliation': 'CHD de Vendée, La Roche-Sur-Yon, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Bodet-Milin', 'Affiliation': 'Service de médecine nucléaire, CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes, France.'}, {'ForeName': 'Roch', 'Initials': 'R', 'LastName': 'Houot', 'Affiliation': ""Service d'Hématologie Clinique, CHU de Rennes, Université de Rennes, INSERM U1236, Rennes, France.""}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Oberic', 'Affiliation': ""Service d'hématologie, IUC Toulouse Oncopole, Toulouse, France.""}, {'ForeName': 'Krimo', 'Initials': 'K', 'LastName': 'Bouabdallah', 'Affiliation': ""Service d'Hématologie, CHU Bordeaux, Bordeaux, France.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Bescond', 'Affiliation': ""Service d'Hématologie, CHU Angers, Angers, France.""}, {'ForeName': 'Ghandi', 'Initials': 'G', 'LastName': 'Damaj', 'Affiliation': 'Haematology Institute, Normandy University School of Medicine, Caen, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'CHU de Limoges, Limoges, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Daguindau', 'Affiliation': 'Centre Hospitalier Annecy-Genevois, Epagny Metz-Tessy, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Moreau', 'Affiliation': ""Service d'anatomo-pathologie, CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes, France.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': ""Département d'Hématologie and U1245, Centre Henri Becquerel, Université de Rouen, Rouen, France.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Ribrag', 'Affiliation': ""Département des Innovations Thérapeutiques et Essais Précoces, Université Paris-Saclay, Département d'Hématologie, Gustave Roussy, Université Paris-Saclay, Paris, France.""}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Delfau-Larue', 'Affiliation': 'Biological Haematology and Immunology Department, Groupe Hospitalier Mondor, Assistance Publique Hôpitaux de Paris, INSERM U955, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Department of Adult Haematology, Université de Paris, Hôpital Necker-Enfants Malades, Assistance-Publique, Hôpitaux de Paris, Imagine Institute, INSERM U1153, Paris, France.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Macintyre', 'Affiliation': 'Onco-Haematology, Université de Paris, Hôpital and Institut Necker-Enfants Malades, Assistance-Publique-Hôpitaux de Paris, INSERM U1151, Paris, France.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30291-X']
2918,32971040,Effects of once-weekly subcutaneous semaglutide on kidney function and safety in patients with type 2 diabetes: a post-hoc analysis of the SUSTAIN 1-7 randomised controlled trials.,"BACKGROUND


Patients with type 2 diabetes have a high risk of developing chronic kidney disease. We examined the effects of semaglutide on kidney function and safety in a large, broad type 2 diabetes population.
METHODS


We did a post-hoc analysis of 8416 patients with type 2 diabetes enrolled in the SUSTAIN 1-5 and SUSTAIN 7 randomised controlled trials, and the SUSTAIN 6 cardiovascular outcomes trial, to examine the effects of once-weekly subcutaneous semaglutide 0·5 mg and 1·0 mg versus comparators (active treatments or placebo) on estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and kidney adverse events. Data from SUSTAIN 1-5 and SUSTAIN 7 were pooled. eGFR and UACR were also analysed by kidney function and albuminuria status.
FINDINGS


In SUSTAIN 1-5 and SUSTAIN 7, eGFR decreased from baseline to week 12 with all active treatments; estimated treatment differences (ETDs) versus placebo were -2·15 (95% CI -3·47 to -0·83) mL/min per 1·73 m 2  with semaglutide 0·5 mg and -3·00 (-4·31 to -1·68) mL/min per 1·73 m 2  with semaglutide 1·0 mg; after week 12, eGFR plateaued. In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58 [95% CI -2·92 to -0·25] mL/min per 1·73 m 2  with semaglutide 0·5 mg and -2·02 [-3·35 to -0·68] mL/min per 1·73 m 2  with semaglutide 1·0 mg). In SUSTAIN 6, the decline in eGFR was greater with semaglutide than with placebo from baseline to week 16 (ETD -1·29 [95% CI -2·07 to -0·51] mL/min per 1·73 m 2  with semaglutide 0·5 mg and -1·56 [-2·33 to -0·78] mL/min per 1·73 m 2  with semaglutide 1·0 mg), but not from week 16 to week 104 (1·29 [0·30 to 2·28] mL/min per 1·73 m 2  with semaglutide 0·5 mg and 2·44 [1·45 to 3·44] mL/min per 1·73 m 2  with semaglutide 1·0 mg). Overall (ie, from baseline to week 104), the eGFR decline in SUSTAIN 6 was similar between semaglutide and placebo (ETD 0·07 [95% CI -0·92 to 1·07] mL/min per 1·73 m 2  with semaglutide 0·5 mg and 0·97 [-0·03 to 1·97] mL/min per 1·73 m 2  with semaglutide 1·0 mg). In SUSTAIN 1-5, UACR ratios at end of treatment to baseline were 0·917 with semaglutide 0·5 mg, 0·836 with semaglutide 1·0 mg, and 1·239 with placebo; at end of treatment, greater reductions in UACR were observed with semaglutide versus placebo (estimated treatment ratios 0·74 [95% CI 0·64 to 0·85] for semaglutide 0·5 mg and 0·68 [0·59 to 0·78] for semaglutide 1·0 mg). In SUSTAIN 6, UACR ratios at end of treatment (week 104) to baseline were 0·973 with semaglutide 0·5 mg, 0·858 with semaglutide 1·0 mg, and 1·302 with placebo; at week 104, greater reductions in UACR were observed with semaglutide versus placebo (estimated treatment ratios 0·75 [95% CI 0·66 to 0·85] for semaglutide 0·5 mg and 0·66 [0·58 to 0·75] for semaglutide 1·0 mg). In SUSTAIN 1-7, eGFR initially declined in patients with normal kidney function (and in those with mild kidney impairment with semaglutide 1·0 mg in SUSTAIN 6), but overall (ie, by week 30 for SUSTAIN 1-5 and SUSTAIN 7, and week 104 for SUSTAIN 6), eGFR did not differ between semaglutide and placebo. In SUSTAIN 1-6, UACR decreased in patients with pre-existing microalbuminuria or macroalbuminuria at baseline; it did not change or increased in those with normoalbuminuria at baseline. Kidney adverse events were balanced between treatment groups.
INTERPRETATION


Across the SUSTAIN 1-7 trials, semaglutide was associated with initial reductions in eGFR that plateaued, and marked reductions in UACR. This post-hoc analysis suggests no increase in the risk of kidney adverse events with semaglutide versus the active comparators used across SUSTAIN 1-7.
FUNDING


Novo Nordisk.",2020,"In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58","['Patients with type 2 diabetes', 'patients with type 2 diabetes', '8416 patients with type 2 diabetes enrolled in the SUSTAIN 1-5']","['semaglutide', '0·5 mg and -3·00 ', '0·25', 'once-weekly subcutaneous semaglutide 0·5', 'once-weekly subcutaneous semaglutide', 'placebo (ETD -1·58', '4·31 to -1·68', '1·56', ' mL/min per 1·73 m 2  with semaglutide 0·5', 'placebo', 'semaglutide 0·5 mg and -2·02', '0·51] mL/min per 1·73 m 2  with semaglutide 0·5', '2·33 to -0·78', 'mg and 1·0 mg versus comparators (active treatments or placebo']","['eGFR and UACR', 'kidney function and albuminuria status', 'decline in eGFR', 'UACR ratios', 'kidney function and safety', 'eGFR decline', 'UACR', 'eGFR', 'risk of kidney adverse events', 'Kidney adverse events', 'estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and kidney adverse events', 'normal kidney function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]",8416.0,0.16795,"In SUSTAIN 1-5 and SUSTAIN 7, from baseline to end of treatment the decline in eGFR was greater with semaglutide than with placebo (ETD -1·58","[{'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center, Munich, Germany; Friedrich Alexander University of Erlangen-Nürnberg, Erlangen, Germany. Electronic address: johannes.mann@kms.mhn.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Marso', 'Affiliation': 'HCA Midwest Heart and Vascular Institute, Overland Park, Overland Park, KS, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Seufert', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center -Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Tadayon', 'Affiliation': 'Novo Nordisk, Søborg, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, University of Copenhagen, Hellerup, Denmark.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30313-2']
2919,32971277,Practical Telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial.,"Background Persistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure. Methods Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months. Results Enrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m 2 . Conclusions Because it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice.",2020,"Methods Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management.","['mean age of 58 and is 23% female and 72% African American', 'Patients with Clinic-Refractory Diabetes Mellitus', 'January 2020; 200 patients', 'patients with clinic-refractory diabetes mellitus (PRACTICE-DM']","['comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management', 'standard VHA Home Telehealth (HT) telemonitoring/care coordination']","['diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs', 'Mean baseline HbA1c and BMI']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0618884', 'cui_str': 'IS 23'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",200.0,0.0844592,"Methods Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kobe', 'Affiliation': 'Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Phillip E', 'Initials': 'PE', 'LastName': 'Tarkington', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Hayden B', 'Initials': 'HB', 'LastName': 'Bosworth', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Maciejewski', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Jeffreys', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Smith', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, United States of America.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Strawbridge', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Szabo', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States of America; VA Mid-Atlantic Mental Illness, Research, Education and Clinical Center, Durham, NC, United States of America.'}, {'ForeName': 'Shivan', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Garrett', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Theresa C', 'Initials': 'TC', 'LastName': 'Wilmot', 'Affiliation': 'Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Marcano', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Overby', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Glenda A', 'Initials': 'GA', 'LastName': 'Tisdale', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Durkee', 'Affiliation': 'Department of Pharmacy, Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bullard', 'Affiliation': 'Department of Pharmacy, Durham Veterans Affairs Health Care System, Durham, NC, United States of America.'}, {'ForeName': 'Moahad S', 'Initials': 'MS', 'LastName': 'Dar', 'Affiliation': 'Greenville VA Health Care Center, Greenville, NC, United States of America; Division of Endocrinology, Department of Medicine, Brody School of Medicine at East Carolina University, Greenville, NC, United States of America.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Mundy', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Hiner', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Sonja K', 'Initials': 'SK', 'LastName': 'Fredrickson', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Nadya T', 'Initials': 'NT', 'LastName': 'Majette Elliott', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Howard', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Deborah H', 'Initials': 'DH', 'LastName': 'Jeter', 'Affiliation': 'Central Virginia Veterans Affairs Health Care System, Richmond, VA, United States of America.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Danus', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Change (ADAPT), Durham, NC, United States of America; Division of Endocrinology, Department of Medicine, Duke University School of Medicine, Durham, NC, United States of America. Electronic address: matthew.crowley@duke.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106157']
2920,32971302,"Manual push technique, an alternative route of subcutaneous immunoglobulin administration in chronic inflammatory demyelinating polyradiculoneuropathy: A proof-of-concept study.","OBJECTIVE


Subcutaneous immunoglobulin (SCIg) administered through infusion pump has been reported as effective in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients. In this study we evaluate an alternative technique of SCIg administration, based on the delivery of lower volumes administered daily using manual push technique (MPT) in 10 CIDP patients.
METHODS


In this randomized, controlled, two-arm, crossover clinical trial, CIDP patients were randomly assigned 1:1 to receive SCIg either by MPT or pumps for 4 consecutive months with crossover to the other. The primary objective was to assess whether MPT had the same effectiveness as pumps. The secondary objectives were to assess whether MPT resulted in greater plasma IgG levels and improved quality of life (QoL).
RESULTS


Ten patients (mean age = 48.3) were enrolled. No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales). A positive mean variation of 5.4 % in plasma IgG levels in the group treated with MPT was observed at the end of MPT periods. Treatment interference, which is one of the dimensions of the Life Quality Index, showed a significant improvement in the MPT periods.
CONCLUSION


In CIDP patients, the MPT technique was as effective as pump infusion, allowed comparable, slightly increases plasma IgG levels, and also improved the QoL.",2020,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","['chronic inflammatory demyelinating polyradiculoneuropathy', 'Ten patients (mean age\u202f=\u202f48.3) were enrolled', '10 CIDP patients', 'CIDP patients', 'chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients']","['Subcutaneous immunoglobulin (SCIg', 'manual push technique (MPT', 'subcutaneous immunoglobulin administration', 'SCIg either by MPT', 'MPT']","['efficacy parameters (INCAT, MRC, R-ODS, and GS scales', 'plasma IgG levels', 'plasma IgG levels and improved quality of life (QoL']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032587', 'cui_str': 'Polyradiculoneuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",10.0,0.0784501,"No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales).","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cocito', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: dariococito@yahoo.it.'}, {'ForeName': 'Erdita', 'Initials': 'E', 'LastName': 'Peci', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: erditapeci@gmail.com.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rigaldo', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: simonarigaldo@yahoo.com.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Canavese', 'Affiliation': 'Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy. Electronic address: ccanavese@cittadellasalute.to.it.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Migliaretti', 'Affiliation': 'Dipartimento di Sanità Pubblica e Scienze Pediatriche - Università di Torino, Piazza Polonia, 94, 10126 Torino, Italy. Electronic address: giuseppe.migliaretti@unito.it.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Cossa', 'Affiliation': 'Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy. Electronic address: federico.cossa@icsmaugeri.it.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106240']
2921,32971314,Quality of life after response to acute-phase cognitive therapy for recurrent depression.,"BACKGROUND


Adults with major depressive disorder (MDD) often experience reduced quality of life (QOL). Efficacious acute-phase treatments, including cognitive therapy (CT) or medication, decrease depressive symptoms and, to a lesser degree, increase QOL. We tested longer-term changes in QOL after response to acute-phase CT, including the potential effects of continuation treatment for depression and time-lagged relations between QOL and depressive symptoms.
METHODS


Responders to acute-phase CT (N = 290) completed QOL and depressive symptom assessments repeatedly for 32 post-acute months. Higher-risk responders were randomized to 8 months of continuation treatment (CT, fluoxetine, or pill placebo) and then entered a 24-month follow-up. Lower-risk responders were only assessed for 32 months.
RESULTS


On average, large gains in QOL made during acute-phase CT response were maintained for 32 months. Continuation CT or fluoxetine did not improve QOL relative to pill placebo. Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence. Higher QOL predicted subsequent reductions in depressive symptom severity, but depressive symptom severity did not predict subsequent changes in QOL.
LIMITATIONS


Generalization of results to other patient populations, treatments, and measures is uncertain. The clinical trial was not designed to test relations between QOL and depression. Replication is needed before clinical application of these results.
CONCLUSIONS


Gains in QOL made during response to acute-phase CT are relatively stable and may help protect against relapse/recurrence. Continuation CT or fluoxetine may not further improve QOL among acute-phase CT responders.",2020,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","['Responders to acute-phase CT', 'Adults with major depressive disorder (MDD', 'recurrent depression', 'Higher-risk responders']","['cognitive therapy (CT', 'continuation treatment (CT, fluoxetine, or pill placebo', 'fluoxetine']","['QOL relative', 'depressive symptom severity', 'quality of life (QOL', 'QOL and depressive symptom assessments', 'QOL', 'Quality of life']","[{'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",290.0,0.0234422,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Vittengl', 'Affiliation': 'Department of Psychology, Truman State University, 100 East Normal Street, Kirksville, MO 63501-4221, USA. Electronic address: vittengl@truman.edu.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Robin B', 'Initials': 'RB', 'LastName': 'Jarrett', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9149, USA. Electronic address: Robin.Jarrett@UTSouthwestern.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.059']
2922,32971388,Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults.,"BACKGROUND


Cannabis warning labels can communicate risks, but there is little research on warning perceptions and differences by product type.
METHODS


In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco) were randomly assigned to view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis. The warnings described cannabis risks related to psychosis, addiction, lack of FDA oversight, and impaired driving. We used linear regression to examine perceptions of warnings and product harm as a function of product type (dried or edible) and warning. We examined which warning participants selected as most effective for discouraging youth use and impaired driving.
RESULTS


Participants found the addiction warning (cannabis users: B = -1.04, p < 0.001; cannabis non-users: B = 1.17, p < 0.001) and psychosis warning (users: B = -0.65, p < 0.05; non-users: B = -0.71, p < 0.05) less believable than the driving warning but indicated that they learned more from the psychosis warning than the driving warning (users: B = 0.88, p < 0.01; non-users (B = 1.60, p < 0.001). Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05). The psychosis warning was most frequently selected as the best warning for discouraging youth use.
CONCLUSIONS


Warnings have the potential to educate consumers and impact cannabis harm perceptions. Warnings have similar effects across product types, potentially eliminating the need for product type-specific warnings. The association of cannabis use with risk for psychosis, a topic addressed in Canadian warnings, could be a useful topic of focus in U.S. warnings.",2020,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"['In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco', 'Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults']",['view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis'],"['addiction warning', 'psychosis warning']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0556574', 'cui_str': 'Dried flowers'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",,0.0480856,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA. Electronic address: jpepper@rti.org.'}, {'ForeName': 'Youn Ok', 'Initials': 'YO', 'LastName': 'Lee', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Eggers', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Allen', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108275']
2923,31355323,Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP: PATH extension study.,"Objective


To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP).
Methods


In a 48-week open-label prospective extension study to the PATH study, patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and-if clinically stable-switched to 0.2 g/kg weekly after 24 weeks. Upon CIDP relapse on the 0.2 g/kg dose, 0.4 g/kg was (re)initiated. CIDP relapse was defined as a deterioration by at least 1 point in the total adjusted Inflammatory Neuropathy Cause and Treatment score.
Results


Eighty-two patients were enrolled. Sixty-two patients initially received 0.4 g/kg, 20 patients 0.2 g/kg weekly. Seventy-two received both doses during the study. Sixty-six patients (81%) completed the 48-week study duration. Overall relapse rates were 10% in 0.4 g/kg-treated patients and 48% in 0.2 g/kg-treated patients. After dose reduction from 0.4 to 0.2 g/kg, 51% (27/53) of patients relapsed, of whom 92% (24 of 26) improved after reinitiation of the 0.4 g/kg dose. Two-thirds of patients (19/28) who completed the PATH study without relapse remained relapse-free on the 0.2 g/kg dose after dose reduction in the extension study. Sixty-two patients had adverse events (AEs) (76%), of which most were mild or moderate with no related serious AEs.
Conclusions


Subcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient.
Classification of evidence


This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious.",2019,Overall relapse rates were 10% in 0.4 g/kg-treated patients and 48% in 0.2 g/kg-treated patients.,"['Eighty-two patients were enrolled', 'patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and-if clinically stable-switched to 0.2 g/kg weekly after 24 weeks', 'Sixty-six patients (81%) completed the 48-week study duration', 'patients with CIDP', 'chronic inflammatory demyelinating polyneuropathy (CIDP']","['subcutaneous IgPro20 (Hizentra, CSL Behring', 'subcutaneous immunoglobulin IgPro20']","['CIDP relapse', 'Overall relapse rates', 'adverse events (AEs']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0393819', 'cui_str': 'Chronic inflammatory demyelinating polyradiculoneuropathy'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3181507', 'cui_str': 'IgPro20'}, {'cui': 'C2746518', 'cui_str': 'Hizentra'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0270922', 'cui_str': 'Peripheral demyelinating neuropathy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",82.0,0.0983543,Overall relapse rates were 10% in 0.4 g/kg-treated patients and 48% in 0.2 g/kg-treated patients.,"[{'ForeName': 'Ivo N', 'Initials': 'IN', 'LastName': 'van Schaik', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Orell', 'Initials': 'O', 'LastName': 'Mielke', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'van Geloven', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Sobue', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'John-Philip', 'Initials': 'JP', 'LastName': 'Lawo', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Praus', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Billie L', 'Initials': 'BL', 'LastName': 'Durn', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Cornblath', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Ingemar S J', 'Initials': 'ISJ', 'LastName': 'Merkies', 'Affiliation': 'Department of Neurology (I.N.S.), Amsterdam University Medical Centers, University of Amsterdam, The Netherlands; Spaarne Gasthuis (I.N.S.), Haarlem, The Netherlands; CSL Behring (O.M., M.P., B.L.D.), Marburg, Germany and King of Prussia, PA; Department of Medicine (Neurology) (V.B.), University Health Network, University of Toronto, Canada; Medical Statistics (N.G.), Department of Biomedical Data Sciences, Leiden University Medical Center, The Netherlands; Department of Neurology (H.-P.H.), Medical Faculty, Heinrich Heine University, Düsseldorf, Germany; Department of Neurology (R.A.L.), Cedars-Sinai Medical Center, Los Angeles, CA; Department of Neurology (G.S.), Nagoya University Graduate School of Medicine, Japan; Department of Neurology (D.R.C.), Johns Hopkins University School of Medicine, Baltimore, MD; and Department of Neurology (I.S.J.M.), Maastricht University Medical Center, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000590']
2924,31376437,Extreme spicy food cravers displayed increased brain activity in response to pictures of foods containing chili peppers: an fMRI study.,"In China, the rate of spicy food consumption is rising, and chili pepper is among the most popular spicy foods consumed nationwide. Therefore, investigation into spicy food craving is of public health interest and can also provide better insights into the mechanisms that underlie food cravings more generally. This exploratory study aimed to determine neural circuits underlying spicy food craving by comparing brain response to the cues of foods containing chili peppers in extreme cravers and non-cravers defined by scores on the Spicy Food Craving Questionnaire. A group of extreme cravers (n = 25) and a group of age- and sex-matched non-cravers (n = 26) participated in an fMRI event-related cue-reactivity paradigm, during which pictures of foods with visible chili peppers and pictures of foods with no chili peppers were presented. Results showed that extreme spicy food cravers exhibited increased activation in bilateral insula, left putamen, left dorsal anterior cingulate cortex, right inferior parietal lobule, right lingual gyrus, bilateral cuneus, left precuneus, left fusiform gyrus, and right precentral gyrus compared to non-cravers when exposed to the cues of foods containing chili versus foods without chili. While we did not observe the differential activation of orbitofrontal cortex and amygdala of this contrast in extreme cravers compared to non-cravers. Changes in beta values within the right insula, left putamen, left dorsal anterior cingulate cortex and left precuneus were positively associated with subjective spicy food craving during the scan among extreme cravers. In addition, changes in beta values within right inferior parietal lobule was significantly correlated with the frequency of spicy food intake among extreme cravers. These results align with prior work suggesting that the dorsal striatum, the anterior cingulate cortex and the insula underlie food craving.",2019,"Changes in beta values within the right insula, left putamen, left dorsal anterior cingulate cortex and left precuneus were positively associated with subjective spicy food craving during the scan among extreme cravers.",['A group of extreme cravers (n\u202f=\u202f25) and a group of age- and sex-matched non-cravers (n\u202f=\u202f26) participated in an'],"['fMRI event-related cue-reactivity paradigm, during which pictures of foods with visible chili peppers and pictures of foods with no chili peppers']","['activation in bilateral insula, left putamen, left dorsal anterior cingulate cortex, right inferior parietal lobule, right lingual gyrus, bilateral cuneus, left precuneus, left fusiform gyrus, and right precentral gyrus', 'Spicy Food Craving Questionnaire', 'subjective spicy food craving', 'brain activity']","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0697049', 'cui_str': 'Capsicum frutescens'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}, {'cui': 'C0152307', 'cui_str': 'Structure of cuneus'}, {'cui': 'C0228243', 'cui_str': 'Structure of lateral occipitotemporal gyrus'}, {'cui': 'C0152299', 'cui_str': 'Structure of ascending frontal gyrus'}, {'cui': 'C0453864', 'cui_str': 'Spicy food'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",26.0,0.0161692,"Changes in beta values within the right insula, left putamen, left dorsal anterior cingulate cortex and left precuneus were positively associated with subjective spicy food craving during the scan among extreme cravers.","[{'ForeName': 'Yizhou', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'School of Psychology, Southwest University, Chongqing, China; Key Laboratory of Cognition and Personality (Ministry of Education), Southwest University, Chongqing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'School of Psychology, Southwest University, Chongqing, China; Key Laboratory of Cognition and Personality (Ministry of Education), Southwest University, Chongqing, China.'}, {'ForeName': 'Dana M', 'Initials': 'DM', 'LastName': 'Small', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'School of Psychology, Southwest University, Chongqing, China; Key Laboratory of Cognition and Personality (Ministry of Education), Southwest University, Chongqing, China. Electronic address: chenhg@swu.edu.cn.'}]",Appetite,['10.1016/j.appet.2019.104379']
2925,31453760,Speech polar plots for different directionality settings of SONNET cochlear implant processor.,"Objectives:  The newest CI processor from MED-EL company, the SONNET, has two new directional microphone settings. Besides the Omnidirectional microphone mode, it has the possibility to switch to Natural or Adaptive directionality. Both new modes favour perception of sound coming from a front-facing direction compared to sounds from sources at alternate azimuths. Natural directionality mimics the pinna effect of the normal external ear.  Design:  We undertook to verify the effect of these options  in vivo  by means of clinical audiological tests. Speech reception thresholds were successively measured for a variety of speech presentation azimuths while keeping the noise azimuths constant. Complete 'Speech Reception Threshold (SRT)-Polar-Plots' were obtained from these data for the Omnidirectional and Natural directionality modes of the SONNET. In addition, one 'SRT-point' was also measured in the 'Adaptive' mode for speech coming from 45° azimuth.  Study sample:  A group of 13 adult CI recipients participated. Only one of these subjects had previous experience with the SONNET processor.  Results:  Complete 'SRT-Polar-Plots' could be measured in Natural and Omnidirectional modes in CI recipients within an acceptable timeframe. The pinna-following directionality for Natural mode could be confirmed. Median SRT in noise for speech coming from the 45° azimuth speaker was -5.6 dB SNR for Omnidirectional, -9.1 dB SNR for Natural and -12.8 dB SNR for Adaptive microphone. Natural and Adaptive significantly improved performance compared to Omnidirectional mode at this optimal azimuth of 45° with a median improvement in SRT of 3.5 and 7.2 dB respectively.  Conclusions:  A novel audiological method, 'SRT-Polar-Plot', was developed and described. Significant directionality benefits for Natural and Adaptive mode were confirmed  in vivo  using this technique.",2019,Natural and Adaptive significantly improved performance compared to Omnidirectional mode at this optimal azimuth of 45° with a median improvement in SRT of 3.5 and 7.2 dB respectively.  ,['13 adult CI recipients participated'],[],"[""Complete 'Speech Reception Threshold (SRT)-Polar-Plots""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}]",,0.0202987,Natural and Adaptive significantly improved performance compared to Omnidirectional mode at this optimal azimuth of 45° with a median improvement in SRT of 3.5 and 7.2 dB respectively.  ,"[{'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'De Ceulaer', 'Affiliation': 'The Eargroup , Herentalsebaan 75, B-2100 Antwerp-Deurne , Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pascoal', 'Affiliation': 'The Eargroup , Herentalsebaan 75, B-2100 Antwerp-Deurne , Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nopp', 'Affiliation': 'MED-EL GmbH , Innsbruck , Austria.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Péan', 'Affiliation': 'MED-EL GmbH , Innsbruck , Austria.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'J Govaerts', 'Affiliation': 'The Eargroup , Herentalsebaan 75, B-2100 Antwerp-Deurne , Belgium.'}]",Cochlear implants international,['10.1080/14670100.2019.1655869']
2926,31791707,Online writing about positive life experiences reduces depression and perceived stress reactivity in socially inhibited individuals.,"Therapeutic writing can enhance psychological and physical health. Recent studies have suggested that these kinds of interventions can be effective when delivered online. The present study investigated whether positive emotional writing online can influence psychological and physical health in individuals reporting high levels of negative affectivity, who are most likely to benefit from psychological intervention (N = 72, M age  = 28.5, SD age  = 8.7), and further, to investigate the potential moderating role of social inhibition. Participants completed self-report measures of physical symptoms, perceived stress, perceived stress reactivity, depression and generalised anxiety, before completing either i) positive emotional writing, or ii) a non-emotive control writing task on an online portal, for 20 min per day over three consecutive days. State anxiety was measured immediately after each writing session, and self-report questionnaires were again administered four weeks post-writing. Socially inhibited individuals exhibited significant reductions in depression and perceived stress reactivity four weeks following positive emotional writing, relative to writing about a neutral topic. The present study supports the efficacy of online therapeutic writing in individuals who, due to their socially inhibited nature, are most likely to benefit from online interventions which avoid interaction with a therapist or other clients.",2020,"Socially inhibited individuals exhibited significant reductions in depression and perceived stress reactivity four weeks following positive emotional writing, relative to writing about a neutral topic.","['individuals reporting high levels of negative affectivity, who are most likely to benefit from psychological intervention (N\xa0=\xa072, M age \xa0=\xa028.5, SD age \xa0=\xa08.7', 'socially inhibited individuals']",['positive emotional writing online'],"['State anxiety', 'physical symptoms, perceived stress, perceived stress reactivity, depression and generalised anxiety, before completing either i) positive emotional writing, or ii) a non-emotive control writing task', 'depression and perceived stress reactivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517880', 'cui_str': '8.7'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]",,0.0515531,"Socially inhibited individuals exhibited significant reductions in depression and perceived stress reactivity four weeks following positive emotional writing, relative to writing about a neutral topic.","[{'ForeName': 'Sarah F', 'Initials': 'SF', 'LastName': 'Allen', 'Affiliation': 'Department of Health Sciences, Faculty of Science, University of York, York, United Kingdom; Stress Research Group, Department of Psychology, Northumbria University, Northumberland Building, Newcastle upon Tyne NE1 8ST, United Kingdom.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Wetherell', 'Affiliation': 'Stress Research Group, Department of Psychology, Northumbria University, Northumberland Building, Newcastle upon Tyne NE1 8ST, United Kingdom.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': 'Stress Research Group, Department of Psychology, Northumbria University, Northumberland Building, Newcastle upon Tyne NE1 8ST, United Kingdom; Faculty of Health and Medical Sciences, University of Western Australia, Perth, Australia. Electronic address: michael4.smith@northumbria.ac.uk.'}]",Psychiatry research,['10.1016/j.psychres.2019.112697']
2927,32975923,Periarticular Neurofascial Dextrose Prolotherapy Versus Physiotherapy for the Treatment of Chronic Rotator Cuff Tendinopathy: Randomized Clinical Trial.,"BACKGROUND/OBJECTIVE


Rotator cuff tendinopathy is a common cause of shoulder pain. We aimed to compare periarticular (neurofascial) dextrose prolotherapy versus physiotherapy for treatment of chronic rotator cuff tendinopathy in the short term.
METHODS


We carried out a randomized clinical trial with 2 arms at a university hospital. In total, 66 patients with chronic rotator cuff tendinopathy, proven by magnetic resonance imaging, were randomly allocated to 2 groups. The outcomes were change in shoulder pain intensity (primary) and disability (secondary) index using a questionnaire for Shoulder Pain and Disability Index. For physiotherapy, participants received superficial heat, transcutaneous electrical nerve stimulation, and pulsed ultrasound. Also, they carried out an exercise program, 10 sessions of 30 minutes for 3 weeks. For prolotherapy, we used 8 mL of 12.5% dextrose and 40 mg of 2% lidocaine. The mixture was injected 2 times with 1-week interval superficially around the shoulder joint and to tender points along the suprascapular nerve.
RESULTS


Neurofascial dextrose was more effective than physiotherapy for alleviating pain in 2 weeks (p < 0.001), and they were similar 3 months after the interventions (p = 0.055). For disability, dextrose was more effective than physiotherapy 2 weeks and 3 months (both p < 0.001) after the interventions. However, the changes in the physiotherapy group seemed to be more sustained.
CONCLUSIONS


Both interventions are effective for the short-term management of rotator cuff tendinopathy. However, prolotherapy is more successful as the initial treatment. Besides, the treatment time is much shorter for dextrose prolotherapy compared with physiotherapy.",2019,"For disability, dextrose was more effective than physiotherapy 2 weeks and 3 months (both p < 0.001) after the interventions.","['66 patients with chronic rotator cuff tendinopathy, proven by magnetic resonance imaging', 'Chronic Rotator Cuff Tendinopathy', '2 arms at a university hospital']","['dextrose and 40 mg of 2% lidocaine', 'prolotherapy', 'superficial heat, transcutaneous electrical nerve stimulation, and pulsed ultrasound', 'Periarticular Neurofascial Dextrose Prolotherapy Versus Physiotherapy', 'periarticular (neurofascial) dextrose prolotherapy versus physiotherapy']","['chronic rotator cuff tendinopathy', 'shoulder pain intensity (primary) and disability (secondary) index using a questionnaire for Shoulder Pain and Disability Index', 'alleviating pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C2143225', 'cui_str': 'Pulsed Ultrasound'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",66.0,0.150536,"For disability, dextrose was more effective than physiotherapy 2 weeks and 3 months (both p < 0.001) after the interventions.","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Kazempour Mofrad', 'Affiliation': 'From the *Department of Anesthesiology and Pain Medicine, Faculty of Medicine, Shahid Beheshti University of Medical Sciences †Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Aja University of Medical Sciences ‡Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Rezasoltani', 'Affiliation': ''}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Dadarkhah', 'Affiliation': ''}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Kazempour Mofrad', 'Affiliation': ''}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Abdorrazaghi', 'Affiliation': ''}, {'ForeName': 'Sirous', 'Initials': 'S', 'LastName': 'Azizi', 'Affiliation': ''}]",Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases,['10.1097/RHU.0000000000001218']
2928,32976051,Effects of an Olive By-Product Called Pâté on Cardiovascular Risk Factors.,"BACKGROUND


The nutraceutical effects of  Olea europaea  L. products are mainly due to phenolic compounds. During olive milling, most of the total phenols remain in the process by-products.
AIM


We aimed to evaluate the effects of a specific by-product of olive oil called ""pâté"" (OlP) administered as tablets, on cardiovascular and metabolic risk factors.
METHODS


The study was a crossover trial with 2 intervention periods. Nineteen participants (mean age: 38 years) took 4 tablets/day of either olive pâté (corresponding to 30 mg/day of hydroxytyrosol) or placebo for 2 months followed by a 2-month washout and another 2 months of crossed over treatment.
RESULTS


After the intervention with pâté, participants showed a statistically significant reduction in plasma levels of total cholesterol (-10.8 mg/dL), LDL cholesterol (-10.8 mg/dL) and urea (-4.1 mg/dL), and a significant increase in calcium levels (+0.3 mg/dL). Leukocyte response to exogenous oxidative stress was significantly reduced (-12.8%) and levels of the antioxidant transcription factor Nrf-2 increased by 88.9%. Plasma levels of the pro-inflammatory protein MCP-1 were significantly reduced (-9.0 pg/mL).
CONCLUSION


In conclusion, the intake of OlP showed positive effects on several cardiovascular risk factors, demonstrating the nutraceutical potential of a widely available but, to date, underestimated olive oil by-product.",2020,"Plasma levels of the pro-inflammatory protein MCP-1 were significantly reduced (-9.0 pg/mL).
",['Nineteen participants (mean age: 38\u2009years) took 4 tablets/day of either'],"['specific by-product of olive oil called ""pâté"" (OlP', 'Olive By-Product Called Pâté', 'olive pâté (corresponding to 30\u2009mg/day of hydroxytyrosol) or placebo']","['Plasma levels of the pro-inflammatory protein MCP-1', 'Cardiovascular Risk Factors', 'LDL cholesterol', 'Leukocyte response to exogenous oxidative stress', 'antioxidant transcription factor Nrf-2', 'plasma levels of total cholesterol', 'calcium levels']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0243264', 'cui_str': 'hydroxytyrosol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}, {'cui': 'C0118522', 'cui_str': 'GA-Binding Protein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}]",,0.0917439,"Plasma levels of the pro-inflammatory protein MCP-1 were significantly reduced (-9.0 pg/mL).
","[{'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Dinu', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Giuditta', 'Initials': 'G', 'LastName': 'Pagliai', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Scavone', 'Affiliation': 'Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bellumori', 'Affiliation': 'Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cecchi', 'Affiliation': 'Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Nediani', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences ""Mario Serio"", University of Florence, Florence, Italy.'}, {'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Maggini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sofi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Giovannelli', 'Affiliation': 'Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Mulinacci', 'Affiliation': 'Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2020.1813060']
2929,32976087,Emotion and Motivation Consequences of Attributional Training During a Novel Physical Task.,"Purpose : Students' positive emotional experiences are an essential physical education outcome because they promote achievement-oriented cognition and behavior. The manner in which students attribute success and failure triggers emotional experiences. Students' beliefs that success is under their control are thought to be a precursor to positive emotions. Research on these relationships has mostly been observational; thus, experimental design was used to address this gap. The purpose of this study was to investigate the effects of attributional training (AT) on students' emotions and motivation toward a PE-related task.  Method : Participants were female university students ( N  = 144; Mage = 20.92, SD = 2.13) recruited from Kinesiology courses. Participants were randomly assigned to one of the three experimental treatments (high AT = 46; low AT = 49; control = 49). Each treatment group received targeted control belief prompts, instruction, and feedback while learning a novel task. Data were collected on students' emotions and motivation before and after treatment.  Results : Repeated measures analysis showed that participants receiving high AT increased enjoyment and reduced boredom over time compared to other groups. Feelings of anxiety trended down over time in all three groups while feelings of relief trended up. Free-choice activity did not show a significant group by time interaction.  Conclusion : Our results show that AT can influence control beliefs in ways that increase students' enjoyment and reduce boredom in physical education tasks. Therefore, training physical education teachers to create a high AT learning environment appears to be a viable strategy for promoting adaptive emotions when students are learning novel tasks.",2020,Our results show that AT can influence control beliefs in ways that increase students' enjoyment and reduce boredom in physical education tasks.,"[""students' emotions and motivation toward a PE-related task"", 'Participants were female university students ( N \xa0= 144; Mage\xa0=\xa020.92, SD\xa0=\xa02.13) recruited from Kinesiology courses']","['attributional training (AT', 'targeted control belief prompts, instruction, and feedback while learning a novel task', 'Attributional Training']","['Emotion and Motivation Consequences', 'Feelings of anxiety', ""students' enjoyment and reduce boredom in physical education tasks"", 'enjoyment and reduced boredom over time', 'Free-choice activity']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.015459,Our results show that AT can influence control beliefs in ways that increase students' enjoyment and reduce boredom in physical education tasks.,"[{'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Simonton', 'Affiliation': 'University of Memphis.'}, {'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Garn', 'Affiliation': 'Louisiana State University.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1817836']
2930,32970955,Osteochondroplasty and Labral Repair for the Treatment of Young Adults With Femoroacetabular Impingement: A Randomized Controlled Trial.,"BACKGROUND


Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults.
PURPOSE


To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol-5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months.
RESULTS


At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, -7.22 to 7.45];  P  = .98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, -5.03 [95% CI, -10.40 to -0.03];  P  = .049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89];  P  = .026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%).
CONCLUSION


Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group.
REGISTRATION


NCT01623843 (ClinicalTrials.gov identifier).",2020,"For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, -5.03 [95% CI, -10.40 to -0.03];  ","['Young Adults With Femoroacetabular Impingement', 'young adults', 'A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis']","['FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair', 'Osteochondroplasty and Labral Repair', 'osteochondroplasty']","['reoperation rate', 'hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol-5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events', 'HOS activities of daily living domain', 'pain (VAS', 'patient-reported pain (using the 100-point visual analog scale [VAS', 'pain or function', 'reoperation included hip pain']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C2936290', 'cui_str': 'Femoral acetabular impingement'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}]","[{'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0265264', 'cui_str': 'Holt-Oram syndrome'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}]",220.0,0.252438,"For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, -5.03 [95% CI, -10.40 to -0.03];  ","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Olufemi R', 'Initials': 'OR', 'LastName': 'Ayeni', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Karlsson', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Musahl', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Simunovic', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Duong', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Asheesh', 'Initials': 'A', 'LastName': 'Bedi', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Järvinen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Naudie', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Seppänen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Slobogean', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Skelly', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Shanmugaraj', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Crouch', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Buckingham', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ramsay', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Petteri', 'Initials': 'P', 'LastName': 'Kousa', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Carsen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Hema', 'Initials': 'H', 'LastName': 'Choudur', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sim', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Johnston', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Wong', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ryland', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sparavalo', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Whelan', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gavin C A', 'Initials': 'GCA', 'LastName': 'Wood', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Howells', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Grant', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Naudie', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Bryn', 'Initials': 'B', 'LastName': 'Zomar', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pollock', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Willits', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Firth', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Wanlin', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alliya', 'Initials': 'A', 'LastName': 'Remtulla', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kaniki', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Etienne L', 'Initials': 'EL', 'LastName': 'Belzile', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Turmel', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Uffe', 'Initials': 'U', 'LastName': 'Jørgensen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Gam-Pedersen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Tays', 'Initials': 'T', 'LastName': 'Hatanpää', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Raine', 'Initials': 'R', 'LastName': 'Sihvonen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Raivio', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Toivonen', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mari Pirjetta', 'Initials': 'MP', 'LastName': 'Routapohja', 'Affiliation': 'Investigation performed at McMaster University, Hamilton, Ontario, Canada.'}]",The American journal of sports medicine,['10.1177/0363546520952804']
2931,32971053,Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial.,"BACKGROUND


Community-based delivery of antiretroviral therapy (ART) for HIV, including ART initiation, clinical and laboratory monitoring, and refills, could reduce barriers to treatment and improve viral suppression, reducing the gap in access to care for individuals who have detectable HIV viral load, including men who are less likely than women to be virally suppressed. We aimed to test the effect of community-based ART delivery on viral suppression among people living with HIV not on ART.
METHODS


We did a household-randomised, unblinded trial (DO ART) of delivery of ART in the community compared with the clinic in rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda. After community-based HIV testing, people living with HIV were randomly assigned (1:1:1) with mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills. The primary outcome was HIV viral suppression at 12 months. If the difference in viral suppression was not superior between study groups, an a-priori test for non-inferiority was done to test for a relative risk (RR) of more than 0·95. The cost per person virally suppressed was a co-primary outcome of the study. This study is registered with ClinicalTrials.gov, NCT02929992.
FINDINGS


Between May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men. Retention at the month 12 visit was 95% (n=1253). At 12 months, community-based ART increased viral suppression compared with the clinic group (306 [74%] vs 269 [63%], RR 1·18, 95% CI 1·07-1·29; p superiority =0·0005) and the hybrid approach was non-inferior (282 [68%] vs 269 [63%], RR 1·08, 0·98-1·19; p non-inferiority =0·0049). Community-based ART increased viral suppression among men (73%, RR 1·34, 95% CI 1·16-1·55; p superiority <0·0001) as did the hybrid approach (66%, RR 1·19, 1·02-1·40; p superiority =0·026), compared with clinic-based ART (54%). Viral suppression was similar for men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group. With efficient scale-up, community-based ART could cost US$275-452 per person reaching viral suppression. Community-based ART was considered safe, with few adverse events.
INTERPRETATION


In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender. Community-based ART should be implemented and evaluated in different contexts for people with detectable viral load.
FUNDING


The Bill & Melinda Gates Foundation; the University of Washington and Fred Hutch Center for AIDS Research; the Wellcome Trust; the University of Washington Royalty Research Fund; and the University of Washington King K Holmes Endowed Professorship in STDs and AIDS.",2020,"In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender.","['After community-based HIV testing, people living with HIV', 'Between May 26, 2016, and March 28, 2019, of 2479 assessed for eligibility, 1315 people living with HIV and not on ART with detectable viral load at baseline were randomly assigned; 666 (51%) were men', 'people living with HIV not on ART', 'men (n=156 [73%]) and women (n=150 [75%]) in the community-based ART group', 'rural and peri-urban settings in KwaZulu-Natal, South Africa and the Sheema District, Uganda', 'for HIV in South Africa and Uganda (DO ART', 'people with detectable viral load']","['mobile phone software to community-based ART initiation with quarterly monitoring and ART refills through mobile vans; ART initiation at the clinic followed by mobile van monitoring and refills (hybrid approach); or standard clinic ART initiation and refills', 'antiretroviral therapy (ART', 'community-based ART delivery', 'Community-based antiretroviral therapy versus standard clinic-based services']","['Viral suppression', 'HIV viral suppression', 'viral suppression']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0557775', 'cui_str': 'Van'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",,0.528336,"In high and medium HIV prevalence settings in South Africa and Uganda, community-based delivery of ART significantly increased viral suppression compared with clinic-based ART, particularly among men, eliminating disparities in viral suppression by gender.","[{'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA; Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: rbarnaba@uw.edu.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Szpiro', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'van Rooyen', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa; MRC/Wits Developmental Pathways for Health Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Asiimwe', 'Affiliation': 'Integrated Community-Based Initiatives, Kabwohe, Uganda.'}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Norma C', 'Initials': 'NC', 'LastName': 'Ware', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Torin T', 'Initials': 'TT', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Meighan L', 'Initials': 'ML', 'LastName': 'Krows', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'van Heerden', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa; MRC/Wits Developmental Pathways for Health Research Unit, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Joseph', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shahmanesh', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Monique A', 'Initials': 'MA', 'LastName': 'Wyatt', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kombi', 'Initials': 'K', 'LastName': 'Sausi', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Bosco', 'Initials': 'B', 'LastName': 'Turyamureeba', 'Affiliation': 'Integrated Community-Based Initiatives, Kabwohe, Uganda.'}, {'ForeName': 'Nsika', 'Initials': 'N', 'LastName': 'Sithole', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morrison', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Adrienne E', 'Initials': 'AE', 'LastName': 'Shapiro', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D Allen', 'Initials': 'DA', 'LastName': 'Roberts', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Koole', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bershteyn', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'The Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(20)30313-2']
2932,32971156,The Effect of Beta-Glucan Supplementation on Glycemic Control and Variability in Adolescents with Type 1 Diabetes Mellitus.,"AIMS


This study aimed to investigate whether supplemental soluble fiber, oat β-glucan, has any effect on glycemic control and variability of adolescents with type 1 diabetes mellitus.
METHODS


This study was conducted in 30 adolescents with type 1 diabetes mellitus and it consisted of three phases lasting one week. At Phase I, all subjects followed a standard diet program. For Phase II and Phase III, the subjects continued their standard diet program and added natural oat flakes containing 3 g/day and 6 g/day β-glucan, respectively. Glucose levels were monitored by continuous glucose monitoring (CGM). The maximal, minimal, mean and daytime and night blood glucose levels, percentages of glucose values in a target range and below and above a target values were calculated for each of the phases. Premeal, postmeal, peak blood glucose values and peak times of meals were evaluated for each of the phases. Glycemic variability was measured via SD, CV, MAGE, IQR, MODD, LBGI, HBGI, and CONGA parameters.
RESULTS


The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p<0.05). Minimal blood glucose levels were the highest at Phase III (p<0.05). Phase I, II, and III showed similar durations elapsed for Level 2 and Level 1 hypoglycemia, euglycemia, Level 1 and Level 2 hyperglycemia (p>0.05). Premeal and postmeal blood glucose levels were lowest at Phase III for breakfast, lunch, and overall (p<0.05). The lowest peak blood glucose levels were detected at Phase III for breakfast, lunch, dinner and overall (p<0.05). Phase III also showed delayed peaks for all time-points (p<0.05 for each) compared to other phases. Phase III had significantly lower levels of SD, CV, LBGI, and CONGA levels than those in either Phase I or Phase II (p<0.05 for each).
CONCLUSION


6 g/day oat β-glucan have favorable outcomes in glycemic control and variability in adolescents with type 1 diabetes mellitus.",2020,"The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p<0.05).","['Adolescents with Type 1 Diabetes Mellitus', '30 adolescents with type 1 diabetes mellitus and it consisted of three phases lasting one week', 'adolescents with type 1 diabetes mellitus']","['Beta-Glucan Supplementation', 'supplemental soluble fiber, oat β-glucan']","['lowest peak blood glucose levels', 'levels of SD, CV, LBGI, and CONGA levels', 'Premeal, postmeal, peak blood glucose values and peak times of meals', 'maximal, minimal, mean and daytime and night blood glucose levels, percentages of glucose values', 'Glycemic Control and Variability', 'Glucose levels', 'maximal, mean and daytime and night blood glucose levels', 'Minimal blood glucose levels', 'Glycemic variability was measured via SD, CV, MAGE, IQR, MODD, LBGI, HBGI, and CONGA parameters', 'glycemic control and variability', 'Premeal and postmeal blood glucose levels', 'Level 2 and Level 1 hypoglycemia, euglycemia, Level 1 and Level 2 hyperglycemia (p>0.05']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C1134651', 'cui_str': 'Beta glucan'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3661727', 'cui_str': 'Soluble fiber'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",30.0,0.00984219,"The maximal, mean and daytime and night blood glucose levels were the lowest at Phase III (p<0.05).","[{'ForeName': 'Rukiye', 'Initials': 'R', 'LastName': 'Bozbulut', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, TURKEY. Electronic address: dyt_rukiye@hotmail.com.'}, {'ForeName': 'Nevin', 'Initials': 'N', 'LastName': 'Şanlıer', 'Affiliation': 'Ankara Medipol University, Faculty of Health Sciences, Department of Nutrition and Dietetics, Ankara, TURKEY.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Döğer', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, TURKEY.'}, {'ForeName': 'Aysun', 'Initials': 'A', 'LastName': 'Bideci', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, TURKEY.'}, {'ForeName': 'Orhun', 'Initials': 'O', 'LastName': 'Çamurdan', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, TURKEY.'}, {'ForeName': 'Peyami', 'Initials': 'P', 'LastName': 'Cinaz', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Pediatric Endocrinology, Ankara, TURKEY.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108464']
2933,32971161,"Treatment of women's sexual dysfunction using Apium graveolens L. Fruit (celery seed): A Double-blind, Randomized, Placebo-controlled Clinical Trial.","ETHNOPHARMACOLOGICAL RELEVANCE


Traditional manuscripts refer to plants such as Apium graveolens L. Fruit (celery seed), which could be used to improve sexual function among women. Since that time, local herbal shops in Iran continue to provide this herb as a natural aphrodisiac product.
AIM OF THE STUDY


This study aimed to evaluate the efficacy and safety of celery seed for the treatment of female sexual dysfunction.
METHODS AND MATERIALS


In this parallel, randomized, double-blinded clinical trial, 80 women were assigned to receive either 500 mg of celery seed or placebo 3 times a day for a period of 6 weeks (n=40 per group). The female sexual function index (FSFI) questionnaire was used to evaluate women's sexual function before and after treatment.
RESULTS


At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P<0.001). Increased total FSFI score is mainly contributed by improvement in the sexual desire (p < 0.001), arousal (p < 0.001), lubrication (p < 0.001), and pain (p = 0.033) domains at the endpoint of study. No serious side effects were noticed in both groups during the study period.
CONCLUSION


It seems that celery seed improved sexual function in women and could be used as a safe, well-tolerated, and effective herbal medicine in women with sexual dysfunction.",2020,"At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P<0.001).","['female sexual dysfunction', ""women's sexual dysfunction using Apium graveolens L. Fruit (celery seed"", 'women with sexual dysfunction', 'Traditional manuscripts refer to plants such as Apium graveolens L. Fruit (celery seed', '80 women']","['placebo', '500 mg of celery seed or placebo', 'Placebo']","['serious side effects', 'total FSFI score', 'efficacy and safety', 'arousal', 'female sexual function index (FSFI) questionnaire', 'sexual function', 'sexual desire', 'lubrication', 'pain']","[{'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0996918', 'cui_str': 'Apium'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0453248', 'cui_str': 'Celery seed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0453248', 'cui_str': 'Celery seed'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",80.0,0.412374,"At the end of the sixth week, an improvement in the total FSFI score was significantly greater in celery seed-treated women than those receiving the placebo (P<0.001).","[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Rahnavard', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Research Center of Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Azima', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrab', 'Initials': 'M', 'LastName': 'Sayadi', 'Affiliation': 'Department of Biostatistics, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Massoumeh', 'Initials': 'M', 'LastName': 'Emamghoreishi', 'Affiliation': 'Department of Pharmacology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Maasumeh Kaviani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: nasadi2012@yahoo.ca.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113400']
2934,32971163,Episiotomy wound healing by Commiphora myrrha (Nees) Engl. and Boswellia carteri Birdw. in primiparous women: A randomized controlled trial.,"ETHNOPHARMACOLOGICAL RELEVANCE


Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl. (myrrh) and Boswellia carteri Birdw. (frankincense), which could be used to improve wound healing process. Since that time, local midwives in Iran continue to provide these herbs to precipitate episiotomy wound healing.
AIM OF THE STUDY


To investigate the efficacy and safety of myrrh- and frankincense-based sitz-baths on episiotomy wound healing in primiparous women.
MATERIALS AND METHODS


This randomized controlled trial was conducted on 90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019. Study participants were randomly allocated in three groups (2 intervention groups and 1 control group). Women in intervention groups were assigned to receive either 10-minute sitz-bath of myrrh extract or frankincense extract twice a day for 1 week. While the women in control group received the betadine sitz-bath for the same period of time. The main outcome was the episiotomy wound healing, which was measured using the REEDA scale before intervention, on 2nd and 7th postpartum days.
RESULTS


An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd  (p=0.003 and p<0.001) and 7 th  (p=0.043 and p=0.015) postpartum days. However, the total REEDA score was not statistically different between the frankincense and betadine groups on 2 nd  and 7 th  postpartum days (p>0.05).
CONCLUSION


The present results suggest that myrrh was more efficient than frankincense and betadine in healing of the episiotomy wound and could be recommended as a safe natural therapy.",2020,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd  (p=0.003 and p<0.001) and 7 th  (p=0.043 and p=0.015) postpartum days.,"['primiparous women', 'Traditional Persian medicine manuscripts refer to plants such as Commiphora myrrha (Nees) Engl', '90 primiparous women with singleton pregnancies after normal vaginal delivery at Hafez hospital affiliated to Shiraz University of Medical Sciences from July to October 2019']","['betadine sitz-bath', 'myrrh- and frankincense-based sitz-baths', 'betadine', '10-minute sitz-bath of myrrh extract or frankincense extract']","['total REEDA score', 'efficacy and safety', 'Episiotomy wound healing', 'episiotomy wound healing, which was measured using the REEDA scale', 'episiotomy wound healing']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C1536360', 'cui_str': 'Commiphora molmol'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C0207011', 'cui_str': 'Myrrh extract'}, {'cui': 'C0949991', 'cui_str': 'Boswellia sacra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3256678', 'cui_str': 'Frankincense extract'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",90.0,0.0403952,An improvement in the episiotomy wound healing was significantly greater in patients receiving myrrh than those receiving the frankincense or betadine on 2 nd  (p=0.003 and p<0.001) and 7 th  (p=0.043 and p=0.015) postpartum days.,"[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: farajiaz@sums.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Aghdaki', 'Affiliation': 'Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: maryam.aghdaki@yahoo.com.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hessamikamran@gmail.com.'}, {'ForeName': 'Ayda', 'Initials': 'A', 'LastName': 'Hosseinkhani', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: hoseinkhan@sums.ac.ir.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Roozmeh', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: dr.roozmeh1995@yahoo.com.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: nasadi2012@yahoo.ca.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: vafaeih@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: kasraeemm@yahoo.com.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'School of Nursing &Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: royakianbagheri64@gmail.com.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: bazrafshan.kh@gmail.com.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Foroughinia', 'Affiliation': 'Box Hill Hospital, FRANZCOG, Eastern Health, Victoria, Australia. Electronic address: Foroughinialeila@yahoo.com.au.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113396']
2935,32971449,"Effects of a nurse-led positive psychology intervention on sexual function, depression and subjective well-being in postoperative patients with early-stage cervical cancer: A randomized controlled trial.","BACKGROUND


Sexual dysfunction is a common long-term complication of cervical cancer and its treatment. However, due to traditional Chinese culture, there are few studies on interventions to improve sexual function in China.
OBJECTIVES


To evaluate the effectiveness of a nurse-led positive psychology intervention on sexual function, depression and subjective well-being amongst postoperative patients with early-stage cervical cancer.
DESIGN


A randomized controlled trial.
SETTINGS AND METHODS


Patients who had undergone radical hysterectomy for early-stage cervical cancer and were followed up in gynaecological clinics were recruited via convenience sampling from three tertiary hospitals in Chongqing, China. Patients who met the inclusion criteria and agreed to participate (N = 91) were randomly assigned to a nurse-led positive psychology intervention (intervention group, n = 46) or usual care (control group, n = 45). The Female Sexual Function Index, Self-rating Depression Scale and Index of Well-being were used to assess sexual function, depression and subjective well-being, respectively, at baseline and 3 and 6 months after the intervention. Data were analysed by the chi-square test, Mann-Whitney U test, t-test and Pearson correlation analysis.
RESULTS


Compared with participants in the control group, participants in the intervention group showed significant improvements in sexual function (mean difference [MD]: -3.95, P = 0.005 at 3 months post-intervention; MD: -4.36, P = 0.001 at 6 months post-intervention). In addition, at 3 and 6 months after the intervention, the number of patients with improvements in their levels of depression and well-being in the intervention group was higher than that in the control group (P<0.05). The Pearson correlation analysis results showed that there was a negative correlation between sexual function and level of depression in patients (r =-0.612, P<0.001) and that sexual function was positively correlated with subjective well-being (r = 0.638, P<0.001).
CONCLUSION


The intervention group experienced significant improvements in sexual function, depression and subjective well-being. These findings suggest that a nurse-led positive psychology intervention should be implemented for postoperative patients with early-stage cervical cancer.",2020,"The intervention group experienced significant improvements in sexual function, depression and subjective well-being.","['postoperative patients with early-stage cervical cancer', 'Patients who met the inclusion criteria and agreed to participate (N\xa0=\xa091', 'Patients who had undergone radical hysterectomy for early-stage cervical cancer and were followed up in gynaecological clinics were recruited via convenience sampling from three tertiary hospitals in Chongqing, China']","['nurse-led positive psychology intervention', 'nurse-led positive psychology intervention (intervention group, n\xa0=\xa046) or usual care (control group, n\xa0=\xa045']","['sexual function and level of depression', 'sexual function', 'Female Sexual Function Index, Self-rating Depression Scale and Index of Well-being', 'sexual function, depression and subjective well-being']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",91.0,0.084043,"The intervention group experienced significant improvements in sexual function, depression and subjective well-being.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Gynecology, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Gynecology, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, The First Affiliated Hospital of Army Military Medical University, No.30 Gaotanyan Main Street, Shapingba District, Chongqing, 400038, China.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China.'}, {'ForeName': 'Guiqing', 'Initials': 'G', 'LastName': 'Xiong', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China.'}, {'ForeName': 'Xiuni', 'Initials': 'X', 'LastName': 'Gan', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China. Electronic address: ganxn@163.com.'}, {'ForeName': 'Xiuying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Radiology Department, The Second Affiliated Hospital of Chongqing Medical University, No.74 Linjiang Road, Yuzhong District, Chongqing, 400010, China. Electronic address: 851720412@qq.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103768']
2936,32971450,Improving the endothelial dysfunction in type 2 diabetes with chromium and vitamin D 3  byreducing homocysteine and oxidative stress: A randomized placebo-controlled trial.,"BACKGROUND


Chromium picolinate (CrPic) and vitamin D3 are known as two antioxidant micronutrients. Through inducing endothelial dysfunction, oxidants such as homocysteine (Hct) and malondialdehyde (MDA) lead to cardiovascular disease in type 2 diabetes mellitus (T2DM). No published data has directly examined the effects of these two antioxidants on improving the endothelial dysfunction in T2DM throughreducing homocysteine and oxidative stress.
METHODS


Subjects (n = 92) in this randomized, double blind, placebo-control study were randomly assigned to receive oral placebo (group I), D 3  (group II: 50,000 IU/ week), chromium picolinate (CrPic) (group III: 500 μg/day), and both vitamin D 3  and CrPic (group IV) for four months. Fasting blood samples were drawn at study baseline and following intervention to determine Hct, MDA, total antioxidant capacity (TAC), total thiol groups (SHs), vascular cell adhesion molecule- 1 (VCAM-1), and plasminogen activator inhibitor-1 (PAI-1).
RESULTS


After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
CONCLUSION


Our findings suggest that through reducing homocysteine and oxidative stress and improving endothelial dysfunction, chromium and vitamin D 3  co-supplementation might be predictive and preventive of cardiovascular diseasesassociated with T2DM. IRCT, IRCT20190610043852N1, registered 21 October 2019, https://fa.irct.ir/user/trial/42293/view.",2020,"After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
","['Subjects (n = 92', 'type 2 diabetes mellitus (T2DM']","['chromium and vitamin D', 'vitamin D 3  and CrPic', 'Chromium picolinate (CrPic) and vitamin D3', 'oral placebo', 'placebo', 'chromium picolinate (CrPic']","['MDA', 'VCAM-1', 'Hct, MDA, total antioxidant capacity (TAC), total thiol groups (SHs), vascular cell adhesion molecule', 'endothelial dysfunction, oxidants such as homocysteine (Hct) and malondialdehyde (MDA', 'Fasting blood samples', '1 (VCAM-1), and plasminogen activator inhibitor-1 (PAI-1', 'homocysteine and oxidative stress', 'endothelial dysfunction']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.150688,"After intervention, MDA significantly decreased in groups II and IV; TAC significantly increased in group IV, and SHs significantly augmented in group III; Hct was significantly reduced in groups II, III, and IV; and VCAM-1 significantly decreased in groups III and IV and PAI-1 was significantly reduced in groups II, III, and IV.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Imanparast', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Arak University of Medical Sciences, Arak, Iran; Department of Biochemistry, Khomein University of Medical Sciences, Khomein, Iran. Electronic address: Fatemeh.Imanparast@arakmu.ac.ir.'}, {'ForeName': 'Farideh Jalali', 'Initials': 'FJ', 'LastName': 'Mashayekhi', 'Affiliation': 'Department of Biochemistry and Genetics, Faculty of Medicine, Arak University of Medical Sciences, Arak, Iran; Department of Laboratory Sciences, Faculty of Paramedicine, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Kamankesh', 'Affiliation': 'Department of Biochemistry, Khomein University of Medical Sciences, Khomein, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Rafiei', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pegah', 'Initials': 'P', 'LastName': 'Mohaghegh', 'Affiliation': 'Community and Preventive Medicine Specialist, Department of community medicine, Faculty of Medicine, Arak University of Medical Sciences, Arak,Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Alimoradian', 'Affiliation': 'Department of Pharmacology, School of Medicine, Arak University of Medical Sciences, Arak, Iran.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126639']
2937,32971492,Modulation of physiological cross-sectional area and fascicle length of vastus lateralis muscle in response to eccentric exercise.,"In the current study, we investigated the effect of lengthening velocity during eccentric exercise on the modulation of the physiological cross-sectional area (PCSA) and fascicle length of the vastus lateralis (VL) muscle. We hypothesized a greater increase in muscle PCSA after training with lower lengthening velocities and a greater increase in fascicle length after higher lengthening velocities. Forty-seven young men were randomly assigned to either a control (n = 14) or an intervention group (n = 33). The participants of the intervention group were randomly allocated to one of four isokinetic eccentric training protocols of the knee extensors, with four different knee angular velocities (45°/s, 120°/s, 210°/s and 300°/s), yet similar range of motion (25-100° knee joint angle), load magnitude (100% of isometric maximum) and load volume (i.e. similar time under tension for one training set). Before and after an 11-week training period with 3 times per week exercise, muscle volume, pennation angle, fascicle length and PCSA of the VL muscle were measured using magnetic resonance imaging and ultrasonography. After the training, the VL muscle volume and fascicle length increased similarly and approximately 5% in all investigated protocols. The PCSA and pennation angles of the VL did not change after any exercise protocol, indicating negligible radial muscle adaptation after the training. The reason for the found hypertrophy of VL muscle after eccentric training in a wide range of lengthening velocities was mainly a longitudinal muscle growth. Further, the longitudinal muscle growth was independent of the lengthening velocity.",2020,"The PCSA and pennation angles of the VL did not change after any exercise protocol, indicating negligible radial muscle adaptation after the training.",['Forty-seven young men'],"['lengthening velocity during eccentric exercise', 'isokinetic eccentric training protocols of the knee extensors, with four different knee angular velocities']","['VL muscle volume and fascicle length', 'fascicle length', 'muscle PCSA', 'modulation of the physiological cross-sectional area (PCSA) and fascicle length of the vastus lateralis (VL) muscle']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",47.0,0.0272657,"The PCSA and pennation angles of the VL did not change after any exercise protocol, indicating negligible radial muscle adaptation after the training.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Marzilger', 'Affiliation': 'Department of Training and Movement Sciences, Humboldt-Universität zu Berlin, Germany; Berlin School of Movement Science, Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bohm', 'Affiliation': 'Department of Training and Movement Sciences, Humboldt-Universität zu Berlin, Germany; Berlin School of Movement Science, Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Mersmann', 'Affiliation': 'Department of Training and Movement Sciences, Humboldt-Universität zu Berlin, Germany; Berlin School of Movement Science, Humboldt-Universität zu Berlin, Germany.'}, {'ForeName': 'Adamantios', 'Initials': 'A', 'LastName': 'Arampatzis', 'Affiliation': 'Department of Training and Movement Sciences, Humboldt-Universität zu Berlin, Germany; Berlin School of Movement Science, Humboldt-Universität zu Berlin, Germany. Electronic address: a.arampatzis@hu-berlin.de.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2020.110016']
2938,32971524,"Can Use of Silymarin Improve Inflammatory Status in Patients with β-Thalassemia Major? A Crossover, Randomized Controlled Trial.","BACKGROUND


In β-thalassemia major (β-TM) patients, iron overload is one of the main causes of inflammation. This study investigated whether use of silymarin could improve inflammatory status in patients with β-TM and iron overload, through a placebo-controlled, crossover study.
METHODS


Silymarin (140 mg, 3 times a day) or placebo were prescribed to all patients (n = 82) for 12 weeks, and after a 2-week washout period, patients were crossed over to the other group. The efficacy of silymarin was assessed by measuring serum C-reactive protein (CRP) (mg/dL), interleukin (IL)-6 (pg/mL), and IL-10 (pg/mL).
RESULTS


Sixty-nine patients completed the study. Data analysis showed that compared to the placebo, silymarin could decrease CRP, IL-6, and raise IL-10 significantly (the p values for all variables were <0.001). Cohen's d for CRP adjusted according to the baseline CRP value was -1.72, the 95% confidence interval (CI) -2.12 to -1.33. The adjusted Cohen's d equal to -1.12, 95% CI -1.48 to -0.76, and 0.78, 95% CI 0.43-1.12, were also estimated for IL-6 and IL-10, respectively.
CONCLUSION


The results of the current study demonstrate that the combination of iron chelation therapy with silymarin can improve inflammatory status in patients with β-TM in the clinical setting.",2020,"Data analysis showed that compared to the placebo, silymarin could decrease CRP, IL-6, and raise IL-10 significantly (the p values for all variables were <0.001).","['patients with β-TM and iron overload, through a placebo-controlled, crossover study', 'Sixty-nine patients completed the study', 'Patients with β-Thalassemia Major', 'patients with β-TM in the clinical setting']","['placebo', 'Silymarin', 'silymarin']","['CRP, IL-6, and raise IL-10 significantly', 'inflammatory status', 'baseline CRP value', 'serum C-reactive protein (CRP) (mg/dL), interleukin (IL)-6 (pg/mL), and IL-10 (pg/mL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002875', 'cui_str': 'Homozygous beta thalassemia'}, {'cui': 'C0282193', 'cui_str': 'Iron overload'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037135', 'cui_str': 'Silymarin'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}]",,0.389656,"Data analysis showed that compared to the placebo, silymarin could decrease CRP, IL-6, and raise IL-10 significantly (the p values for all variables were <0.001).","[{'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Darvishi-Khezri', 'Affiliation': 'Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mehrnoush', 'Initials': 'M', 'LastName': 'Kosaryan', 'Affiliation': 'Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Karami', 'Affiliation': 'Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Phamaceutical Science Research Center, Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran, researching1905@gmail.com.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mahdavi', 'Affiliation': 'Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Alipour', 'Affiliation': 'Department of Community Medicine, Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Aily', 'Initials': 'A', 'LastName': 'Aliasgharian', 'Affiliation': 'Medical Microbiology, Thalassemia Research Center (TRC), Hemoglobinopathy Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}]",Complementary medicine research,['10.1159/000509829']
2939,32971964,Gaelic4Girls-The Effectiveness of a 10-Week Multicomponent Community Sports-Based Physical Activity Intervention for 8 to 12-Year-Old Girls.,"Girls are less active than boys throughout childhood and adolescence, with limited research focusing on female community sports-based programs. This study aims to assess the effectiveness of a multi-component, community sports-based intervention for increasing girl's physical activity (PA) levels, fundamental movement skill (FMS) proficiency, and psychological wellbeing, as relative to a second treatment group (the traditionally delivered national comparative program), and a third control group. One hundred and twenty female-only participants (mean age = 10.75 ± 1.44 years), aged 8 to 12 years old from three Ladies Gaelic Football (LGF) community sports clubs (rural and suburban) were allocated to one of three conditions: (1) Intervention Group 1 (n = 43) received a novel, specifically tailored, research-informed Gaelic4Girls (G4G) intervention; (2) Intervention Group 2 (n = 44) used the traditionally delivered, national G4G program, as run by the Ladies Gaelic Football (LGF) Association of Ireland; and (3) Control Group 3 (n = 33) received no G4G intervention (group 1 or 2) conditions and were expected to carry out their usual LGF community sports activities. Primary outcome measurements (at both pre- and 10-week follow up) examining the effectiveness of the G4G intervention included (1) PA, (2) FMS and (3) Psychological correlates (enjoyment levels, self-efficacy, peer and parental support). Following a two (pre to post) by three (intervention group 1, intervention group 2, and control group 3) mixed-model ANOVA, it was highlighted that intervention group 1 significantly increased in PA ( p  = 0.003), FMS proficiency ( p  = 0.005) and several psychological correlates of PA ( p  ≤ 0.005). The findings demonstrate that the 10-week, specifically tailored, research-informed G4G intervention is a feasible and efficacious program, leading to a positive effect on the physical and psychological wellbeing of pre-adolescent Irish girls, relative to the traditionally delivered national G4G comparative program and control group conditions.",2020,"The findings demonstrate that the 10-week, specifically tailored, research-informed G4G intervention is a feasible and efficacious program, leading to a positive effect on the physical and psychological wellbeing of pre-adolescent Irish girls, relative to the traditionally delivered national G4G comparative program and control group conditions.","['One hundred and twenty female-only participants (mean age = 10.75 ± 1.44 years), aged 8 to 12 years old from three Ladies Gaelic Football (LGF) community sports clubs (rural and suburban', '8 to 12-Year-Old Girls']","['10-Week Multicomponent Community Sports-Based Physical Activity Intervention', 'traditionally delivered, national G4G program, as run by the Ladies Gaelic Football (LGF) Association of Ireland; and (3) Control Group 3 (n = 33) received no G4G intervention', 'novel, specifically tailored, research-informed Gaelic4Girls (G4G) intervention', 'multi-component, community sports-based intervention']","['effectiveness of the G4G intervention included (1) PA, (2) FMS and (3) Psychological correlates (enjoyment levels, self-efficacy, peer and parental support', ""girl's physical activity (PA) levels, fundamental movement skill (FMS) proficiency, and psychological wellbeing"", 'several psychological correlates of PA', 'FMS proficiency']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0574307', 'cui_str': 'Scottish Gaelic language'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0574307', 'cui_str': 'Scottish Gaelic language'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0418946', 'cui_str': 'Parental support'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",,0.0183106,"The findings demonstrate that the 10-week, specifically tailored, research-informed G4G intervention is a feasible and efficacious program, leading to a positive effect on the physical and psychological wellbeing of pre-adolescent Irish girls, relative to the traditionally delivered national G4G comparative program and control group conditions.","[{'ForeName': 'Orlagh', 'Initials': 'O', 'LastName': 'Farmer', 'Affiliation': 'Sports Studies and Physical Education Program, School of Education, 2 Lucan Place, Western Road, 0000 Cork, Ireland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cahill', 'Affiliation': 'School of Education, Postgraduate Diploma in Special Educational Needs, University College Cork, 0000 Cork, Ireland.'}, {'ForeName': 'Wesley', 'Initials': 'W', 'LastName': ""O'Brien"", 'Affiliation': 'Sports Studies and Physical Education Program, School of Education, 2 Lucan Place, Western Road, 0000 Cork, Ireland.'}]",International journal of environmental research and public health,['10.3390/ijerph17186928']
2940,32971991,KiwiC for Vitality: Results of a Randomized Placebo-Controlled Trial Testing the Effects of Kiwifruit or Vitamin C Tablets on Vitality in Adults with Low Vitamin C Levels.,"Consumption of vitamin C-rich fruit and vegetables has been associated with greater feelings of vitality. However, these associations have rarely been tested in randomized controlled trials. The aim of the current study was to test the effects of eating a vitamin C-rich food (kiwifruit) on subjective vitality and whether effects are driven by vitamin C. Young adults ( n  = 167, 61.1% female, aged 18-35) with plasma vitamin C <40 µmol/L were randomized into three intervention conditions: kiwifruit (2 SunGold™ kiwifruit/day), vitamin C (250 mg tablet/day), placebo (1 tablet/day). The trial consisted of a two-week lead-in, four-week intervention, and two-week washout. Plasma vitamin C and vitality questionnaires (total mood disturbance, fatigue, and well-being) were measured fortnightly. Self-reported sleep quality and physical activity were measured every second day through smartphone surveys. Nutritional confounds were assessed using a three-day food diary during each study phase. Plasma vitamin C reached saturation levels within two weeks for the kiwifruit and vitamin C groups. Participants consuming kiwifruit showed significantly improved mood and well-being during the intervention period; improvements in well-being were sustained during washout. Decreased fatigue and increased well-being were observed following intake of vitamin C alone, but only for participants with consistently low vitamin C levels during lead-in. Diet records showed that participants consuming kiwifruit reduced their fat intake during the intervention period. Intervention effects remained significant when adjusting for age and ethnicity, and were not explained by sleep quality, physical activity, BMI, or other dietary patterns, including fat intake. There were no changes in plasma vitamin C status or vitality in the placebo group. Whole food consumption of kiwifruit improved subjective vitality in adults with low vitamin C status. Similar, but not identical, changes were found for vitamin C tablets suggesting that additional properties of kiwifruit may contribute to improved vitality.",2020,"Intervention effects remained significant when adjusting for age and ethnicity, and were not explained by sleep quality, physical activity, BMI, or other dietary patterns, including fat intake.","['KiwiC for Vitality', 'Young adults ( n  = 167, 61.1% female, aged 18-35) with plasma vitamin C <40 µmol/L', 'adults with low vitamin C status', 'Adults with Low Vitamin C Levels']","['intervention conditions: kiwifruit (2 SunGold™ kiwifruit/day), vitamin C', 'Kiwifruit or Vitamin C Tablets', 'eating a vitamin C-rich food (kiwifruit', 'placebo', 'Placebo', 'vitamin C-rich fruit and vegetables', 'vitamin C']","['Plasma vitamin C and vitality questionnaires (total mood disturbance, fatigue, and well-being', 'plasma vitamin C status or vitality', 'fat intake', 'Self-reported sleep quality and physical activity', 'Plasma vitamin C reached saturation levels', 'sleep quality, physical activity, BMI, or other dietary patterns, including fat intake', 'Decreased fatigue', 'subjective vitality']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0971874', 'cui_str': 'Actinidia deliciosa'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",,0.202544,"Intervention effects remained significant when adjusting for age and ethnicity, and were not explained by sleep quality, physical activity, BMI, or other dietary patterns, including fat intake.","[{'ForeName': 'Tamlin S', 'Initials': 'TS', 'LastName': 'Conner', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Fletcher', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Juliet M', 'Initials': 'JM', 'LastName': 'Pullar', 'Affiliation': 'Centre for Free Radical Research, Department of Pathology and Biomedical Science, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Spencer', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch 8140, New Zealand.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Mainvil', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin 9054, New Zealand.'}, {'ForeName': 'Margreet C M', 'Initials': 'MCM', 'LastName': 'Vissers', 'Affiliation': 'Centre for Free Radical Research, Department of Pathology and Biomedical Science, University of Otago, Christchurch 8140, New Zealand.'}]",Nutrients,['10.3390/nu12092898']
2941,32972007,Effectiveness of  SaBang - DolGi  Walking Exercise Program on Physical and Mental Health of Menopausal Women.,"OBJECTIVE


We investigated the effectiveness of a 12-week SaBang-DolGi walking exercise program on the physical and mental health of menopausal women and aimed to provide the basic data needed to develop health promotion programs for the active and healthy aging of menopausal women.
MATERIALS AND METHODS


The participants comprised 40 women aged 50-65 years who were divided into two randomly selected groups in training sessions (exercising group, n = 21 and control group, n = 19). A physical (grip, muscle and endurance) test and mental health test (simple mental health test II) were conducted using questionnaires with the aim of examining subjects' physical and mental health before and after exercise.
RESULTS


After the intervention, the participants experienced positive changes in the physical dimension, with significant enhancements particularly in mental well-being and menopause-related health and subdomains. Controlled and regular exercise for 12 weeks was significantly correlated with a positive change in vitality and mental health.
CONCLUSIONS


We found that the SaBang-DolGi walking exercise program helps to promote the physical and mental health of menopausal women who are exposed to the various stresses and depressions that accompany physical deterioration; the program was found to encourage active and healthy aging.",2020,"After the intervention, the participants experienced positive changes in the physical dimension, with significant enhancements particularly in mental well-being and menopause-related health and subdomains.","['Menopausal Women', 'participants comprised 40 women aged 50-65 years', 'menopausal women']","['A physical (grip, muscle and endurance) test and mental health test (simple mental health test II', 'training sessions (exercising group', 'SaBang - DolGi  Walking Exercise Program', 'SaBang-DolGi walking exercise program']","['positive change in vitality and mental health', 'mental well-being and menopause-related health and subdomains', 'Physical and Mental Health']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",40.0,0.0282647,"After the intervention, the participants experienced positive changes in the physical dimension, with significant enhancements particularly in mental well-being and menopause-related health and subdomains.","[{'ForeName': 'EunHee', 'Initials': 'E', 'LastName': 'Noh', 'Affiliation': 'Department of Exercise Rehabilitation &Welfare, Gachon University, 191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}, {'ForeName': 'JiYoun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Exercise Rehabilitation &Welfare, Gachon University, 191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}, {'ForeName': 'MunHee', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Health Science, Korea National Sport University, Seoul 05541, Korea.'}, {'ForeName': 'EunSurk', 'Initials': 'E', 'LastName': 'Yi', 'Affiliation': 'Department of Exercise Rehabilitation &Welfare, Gachon University, 191 Hombakmoero, Yeonsu-gu, Incheon 406-799, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186935']
2942,32972114,Survival benefit of concomitant chemoradiation in adult supratentorial primary glioblastoma. A propensity score weighted population-based analysis.,"BACKGROUND


This population study aims to assess the impact of the implementation of the original Stupp protocol on overall survival in patients with new-diagnosed supratentorial primary GBM.
METHODS


The Surveillance, Epidemiology, and End Results (SEER) database was used to study the survival of histologically confirmed adult supratentorial GBM patients diagnosed between 1998 and 2016. Kaplan-Meier, and a univariate and propensity-score weighted multivariate Cox proportional hazard model adjusted for age at diagnosis, sex, race, marital status and extent of resection was used to assess the survival of patients prior to implementation of the Stupp protocol in 2005 (Pre-Stupp) and following implementation of the Stupp Protocol until 2016 (Post Stupp).
RESULTS


6,390 patients satisfied inclusion exclusion criteria. Median survival times were 13 months for the Pre-Stupp and 15 months for Post-Stupp groups (p<0.001). The 1-,2-, 5- and 10- year survival rates for the Pre-Stupp group were 51, 18, 5 and 2% respectively compared to 59, 27, 8 and 4% on the Post-Stupp group. Propensity-score weighted analysis showed a lower mortality risk for patients who underwent concomitant chemoradiation during the Post-Stupp era [HR 0.77, 95% CI 0.62-0.94]. There was a 42 percent relative reduction in the risk of death for patients treated during the Post-Stupp era.
CONCLUSIONS


This population-based propensity-score study with long-term follow-up suggests that the implementation of the Stupp protocol in 2005 had a positive impact on the survival of patients with supratentorial GBM. This ""real-world"" analysis validates the results of the original randomized control trial on which this protocol is based.",2020,Median survival times were 13 months for the Pre-Stupp and 15 months for Post-Stupp groups (p<0.001).,"['adult supratentorial GBM patients diagnosed between 1998 and 2016', '6,390 patients satisfied inclusion exclusion criteria', 'adult supratentorial primary glioblastoma', 'patients with new-diagnosed supratentorial primary GBM']","['concomitant chemoradiation', 'original Stupp protocol']","['mortality risk', 'Survival benefit', 'survival rates', 'risk of death', 'Median survival times', 'overall survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",6390.0,0.196991,Median survival times were 13 months for the Pre-Stupp and 15 months for Post-Stupp groups (p<0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Jusue-Torres', 'Affiliation': 'Department of Neurological Surgery, Loyola University Stritch School of Medicine, Maywood, IL, USA - ignacio.jusuetorres@lumc.edu.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Hulbert', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Barton', 'Affiliation': 'Hematology Oncology, Loyola University Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Melian', 'Affiliation': 'Department of Neurological Surgery, Loyola University Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Anderson', 'Affiliation': 'Department of Neurological Surgery, Loyola University Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Quinones-Hinojosa', 'Affiliation': 'Department of Neurosurgery, Mayo Clinic College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Vikram C', 'Initials': 'VC', 'LastName': 'Prabhu', 'Affiliation': 'Department of Neurological Surgery, Loyola University Stritch School of Medicine, Maywood, IL, USA.'}]",Journal of neurosurgical sciences,['10.23736/S0390-5616.20.05023-7']
2943,32976515,Short-term effect of a smartphone application on the mental health of university students: A pilot study using a user-centered design self-monitoring application for mental health.,"BACKGROUND


Despite the widespread recognition of the importance of mental health in young people, only a small proportion of young people with a mental disorder, including university students, receive mental health care.
OBJECTIVE


We developed a smartphone application (Mental App) for the university students and examined the effects of the app on their mental health.
METHODS


The app was designed according to a questionnaire survey conducted before this study. The Mental App was installed on the students' smartphone and the psychological tests (the Link Stigma Scale, the Center for Epidemiologic Studies Depression Scale, and the 12-item General Health Questionnaire) were performed on the same day. After using the App for two weeks, the students completed a questionnaire survey and underwent the same psychological tests. We compared the results between the app user and non-user group.
RESULTS


A total of 68 students participated, of which 57 students completed the study (app user group, n = 28; control group, n = 29). The mean number of days spent using the app was 5.66 ± 3.16 (mean ± SD). The mean total screen time of the app was 9:03 ± 06:41(min:sec). The mean number of total actions (screen taps or swipes) was 161.91 ± 107.34. There were no significant between-group differences in the ΔLink Stigma Scale score (-0.11 ± 4.28 vs. -0.59 ± 3.30, p = 0.496) or the ΔCenter for Epidemiologic Studies Depression Scale score (-4.39 ± 7.13 vs. -2.07 ± 8.78, p = 0.143). There was a significant between-group difference in the ΔGeneral Health Questionnaire score (-2.21± 2.23 vs. -0.17 ± 2.69, p = 0.007).
CONCLUSIONS


This non-randomized controlled pilot study indicates that the app we developed, may provide effective mental health care for university students, even in the short-term. Trial registration: UMIN000040332.",2020,The mean number of total actions (screen taps or swipes) was 161.91 ± 107.34.,"['68 students participated, of which 57 students completed the study (app user group, n = 28; control group, n = 29', 'mental health', 'university students', 'mental health of university students']","['smartphone application', 'smartphone application (Mental App']","['ΔGeneral Health Questionnaire score', 'Epidemiologic Studies Depression Scale score', 'mean total screen time', 'mean number of days spent', 'ΔLink Stigma Scale score', 'mean number of total actions (screen taps or swipes']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]",68.0,0.0371091,The mean number of total actions (screen taps or swipes) was 161.91 ± 107.34.,"[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kajitani', 'Affiliation': 'Center for Health Sciences and Counseling, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Ikumi', 'Initials': 'I', 'LastName': 'Higashijima', 'Affiliation': 'Content and Creative Design Course, Department of Design, Graduate School of Design, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kaneko', 'Affiliation': 'Cybersecurity Center, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Matsushita', 'Affiliation': 'Center for Health Sciences and Counseling, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Fukumori', 'Affiliation': 'Center for Health Sciences and Counseling, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Daewoong', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Content and Creative Design, Faculty of Design, Kyushu University, Fukuoka, Japan.'}]",PloS one,['10.1371/journal.pone.0239592']
2944,32976523,L-carnitine infusion does not alleviate lipid-induced insulin resistance and metabolic inflexibility.,"BACKGROUND


Low carnitine status may underlie the development of insulin resistance and metabolic inflexibility. Intravenous lipid infusion elevates plasma free fatty acid (FFA) concentration and is a model for simulating insulin resistance and metabolic inflexibility in healthy, insulin sensitive volunteers. Here, we hypothesized that co-infusion of L-carnitine may alleviate lipid-induced insulin resistance and metabolic inflexibility.
METHODS


In a randomized crossover trial, eight young healthy volunteers underwent hyperinsulinemic-euglycemic clamps (40mU/m2/min) with simultaneous infusion of saline (CON), Intralipid (20%, 90mL/h) (LIPID), or Intralipid (20%, 90mL/h) combined with L-carnitine infusion (28mg/kg) (LIPID+CAR). Ten volunteers were randomized for the intervention arms (CON, LIPID and LIPID+CAR), but two dropped-out during the study. Therefore, eight volunteers participated in all three intervention arms and were included for analysis.
RESULTS


L-carnitine infusion elevated plasma free carnitine availability and resulted in a more pronounced increase in plasma acetylcarnitine, short-, medium-, and long-chain acylcarnitines compared to lipid infusion, however no differences in skeletal muscle free carnitine or acetylcarnitine were found. Peripheral insulin sensitivity and metabolic flexibility were blunted upon lipid infusion compared to CON but L-carnitine infusion did not alleviate this.
CONCLUSION


Acute L-carnitine infusion could not alleviated lipid-induced insulin resistance and metabolic inflexibility and did not alter skeletal muscle carnitine availability. Possibly, lipid-induced insulin resistance may also have affected carnitine uptake and may have blunted the insulin-induced carnitine storage in muscle. Future studies are needed to investigate this.",2020,"Peripheral insulin sensitivity and metabolic flexibility were blunted upon lipid infusion compared to CON but L-carnitine infusion did not alleviate this.
","['eight volunteers participated in all three intervention arms and were included for analysis', 'eight young healthy volunteers', 'healthy, insulin sensitive volunteers', 'Ten volunteers']","['L-carnitine infusion', 'Intravenous lipid', 'L-carnitine', 'hyperinsulinemic-euglycemic clamps (40mU/m2/min) with simultaneous infusion of saline (CON), Intralipid (20%, 90mL/h) (LIPID), or Intralipid (20%, 90mL/h) combined with L-carnitine infusion (28mg/kg) (LIPID+CAR', 'intervention arms (CON, LIPID and LIPID+CAR']","['skeletal muscle carnitine availability', 'plasma acetylcarnitine, short-, medium-, and long-chain acylcarnitines', 'Peripheral insulin sensitivity and metabolic flexibility', 'skeletal muscle free carnitine or acetylcarnitine', 'lipid-induced insulin resistance and metabolic inflexibility']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0733854', 'cui_str': 'Intralipid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C4040379', 'cui_str': 'Free carnitine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",8.0,0.0518461,"Peripheral insulin sensitivity and metabolic flexibility were blunted upon lipid infusion compared to CON but L-carnitine infusion did not alleviate this.
","[{'ForeName': 'Yvonne M H', 'Initials': 'YMH', 'LastName': 'Bruls', 'Affiliation': 'Departments of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Yvo J M', 'Initials': 'YJM', 'LastName': 'Op den Kamp', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Phielix', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Lindeboom', 'Affiliation': 'Departments of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Havekes', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Schaart', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Moonen-Kornips', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Joachim E', 'Initials': 'JE', 'LastName': 'Wildberger', 'Affiliation': 'Departments of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Matthijs K C', 'Initials': 'MKC', 'LastName': 'Hesselink', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Departments of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Vera B', 'Initials': 'VB', 'LastName': 'Schrauwen-Hinderling', 'Affiliation': 'Departments of Radiology and Nuclear Medicine, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, Maastricht, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0239506']
2945,32976576,A randomized phase-2 trial of pomalidomide in subjects failing prior therapy of chronic graft-versus-host disease.,"Steroid-refractory chronic graft-versus-host disease (cGvHD) is a therapeutic challenge. Sclerotic skin manifestations are especially difficult to treat. We conducted a randomized phase-2 clinical trial to determine safety, efficacy, and preferred dose of pomalidomide in persons with moderate to severe cGvHD unresponsive to corticosteroids and/or subsequent lines of therapy. Thirty-four subjects were randomized to receive pomalidomide, 0.5 mg/d; LD) orally (n=17) or 2 mg/d at a starting dose of 0.5 mg/d increasing to 2 mg/d over 6 weeks (n=17, HD). Primary endpoint was overall response rate (ORR) at 6 months according to the 2005 NIH cGvHD Response Criteria. Thirty-two had severe sclerotic skin and received a median of 5 (range, 2-10) prior systemic therapies. ORR was 47% (95% confidence interval [95% CI], 30, 65%) in intent-to-treat analyses. All were partial responses with no difference in ORR between the cohorts. ORR was 67% (45-84%) in the 24 evaluable subjects at 6 months. Nine had improvement in NIH joint/fascia scores (p=0.018). Median change from the baseline in body surface area (BSA) of involved skin cGvHD was -7.5% (-10 to +35; p=0.002). The most frequent adverse events (AEs) were lymphopenia, infection, and fatigue. Eight subjects in the HD cohort had dose decreases because of AEs. There was one death in the LD cohort from bacterial pneumonia. Our data indicate anti-fibrotic effects of pomalidomide and possible association with increases in concentrations of blood regulatory T-cell and IL-2. Pomalidomide, 0.5 mg/d, is a safe and effective therapy of advanced corticosteroid-refractory cGvHD.",2020,cGvHD was -7.5% (-10 to +35; p=0.002).,"['subjects failing prior therapy of chronic graft-versus-host disease', 'Thirty-four subjects', 'Thirty-two had severe sclerotic skin and received a median of 5 (range, 2-10) prior systemic therapies', 'persons with moderate to severe cGvHD unresponsive to corticosteroids and/or subsequent lines of therapy']","['Steroid-refractory chronic graft-versus-host disease (cGvHD', 'pomalidomide']","['NIH joint/fascia scores', 'lymphopenia, infection, and fatigue', 'overall response rate (ORR', 'ORR', 'body surface area (BSA) of involved skin', 'cGvHD']","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036429', 'cui_str': 'Sclerosis'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C2347624', 'cui_str': 'pomalidomide'}]","[{'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}]",34.0,0.0923304,cGvHD was -7.5% (-10 to +35; p=0.002).,"[{'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Curtis', 'Affiliation': 'Sibley Memorial Hospital, Sidney Kimmel Cancer Center, Johns Hopkins Medicine, Washington, DC, District of Columbia, United States.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Ostojic', 'Affiliation': 'National Cancer Institute, Center for Cancer Research, Bethesda, Maryland, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Venzon', 'Affiliation': 'Biostatistics and Data Management Section, National Cancer Institute, Bethesda, Maryland, Bethesda, Maryland, United States.'}, {'ForeName': 'Noa G', 'Initials': 'NG', 'LastName': 'Holtzman', 'Affiliation': 'National Cancer Institute, Center for Cancer Research, Bethesda, Maryland, United States.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Pirsl', 'Affiliation': 'National Cancer Institute, National Institutes of Health, Bethesda, Maryland, United States.'}, {'ForeName': 'Zoya J', 'Initials': 'ZJ', 'LastName': 'Kuzmina', 'Affiliation': 'Wilhelminen Hospital, Vienna, Austria.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Baird', 'Affiliation': 'FDA, Silver Spring, Maryland, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Rose', 'Affiliation': 'NCI, Bethesda, Maryland, United States.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Cowen', 'Affiliation': 'National Institutes of Health, Bethesda, Maryland, United States.'}, {'ForeName': 'Jacqueline W', 'Initials': 'JW', 'LastName': 'Mays', 'Affiliation': 'National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, Maryland, United States.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Mitchell', 'Affiliation': 'National Cancer Institute, National Institutes of Health, Rockville, Maryland, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Parsons-Wandell', 'Affiliation': 'National Cancer Institute, Center for Cancer Research, Bethesda, Maryland, United States.'}, {'ForeName': 'Galen', 'Initials': 'G', 'LastName': 'Joe', 'Affiliation': 'National Institutes Of Health, Bethesda, United States.'}, {'ForeName': 'Leora E', 'Initials': 'LE', 'LastName': 'Comis', 'Affiliation': 'National Institutes of Health, Clinical Center, Bethesda, Maryland, United States.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Berger', 'Affiliation': 'National Institutes of Health Clinical Center, Bethesda, Maryland, United States.'}, {'ForeName': 'Iskra', 'Initials': 'I', 'LastName': 'Pusic', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri, United States.'}, {'ForeName': 'Cody J', 'Initials': 'CJ', 'LastName': 'Peer', 'Affiliation': 'Center for Cancer Research, NCI, Bethesda, Maryland, United States.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'National Cancer Institute, Bethesda, Maryland, United States.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'National Cancer Institute, Bethesda, Maryland, United States.'}, {'ForeName': 'Robert Peter', 'Initials': 'RP', 'LastName': 'Gale', 'Affiliation': 'Imperial College London, Los Angeles, California, United States.'}, {'ForeName': 'Frances T', 'Initials': 'FT', 'LastName': 'Hakim', 'Affiliation': 'National Cancer Institute, Bethesda, Maryland, United States.'}, {'ForeName': 'Steven Z', 'Initials': 'SZ', 'LastName': 'Pavletic', 'Affiliation': 'National Cancer Institute, Bethesda, Maryland, United States.'}]",Blood,['10.1182/blood.2020006892']
2946,32976633,A randomized trial of permanent supportive housing for chronically homeless persons with high use of publicly funded services.,"OBJECTIVE


To examine whether randomization to permanent supportive housing (PSH) versus usual care reduces the use of acute health care and other services among chronically homeless high users of county-funded services.
DATA SOURCES


Between 2015 and 2019, we assessed service use from Santa Clara County, CA, administrative claims data for all county-funded health care, jail and shelter, and mortality.
STUDY DESIGN


We conducted a randomized controlled trial among chronically homeless high users of multiple systems. We compared postrandomization outcomes from county-funded systems using multivariate regression analysis.
DATA COLLECTION


We extracted encounter data from an integrated database capturing health care at county-funded facilities, shelter and jails, county housing placement, and death certificates.
PRINCIPAL FINDINGS


We enrolled 423 participants (199 intervention; 224 control). Eighty-six percent of those randomized to PSH received housing compared with 36 percent in usual care. On average, the 169 individuals housed by the PSH intervention have remained housed for 28.8 months (92.9 percent of the study follow-up period). Intervention group members had lower rates of psychiatric ED visits IRR 0.62; 95% CI [0.43, 0.91] and shelter days IRR 0.30; 95% CI [0.17, 0.53], and higher rates of ambulatory mental health services use IRR 1.84; 95% CI [1.43, 2.37] compared to controls. We found no differences in total ED or inpatient use, or jail. Seventy (37 treatment; 33 control) participants died.
CONCLUSIONS


The intervention placed and retained frequent user, chronically homeless individuals in housing. It decreased psychiatric ED visits and shelter use, and increased outpatient mental health care, but not medical ED visits or hospitalizations. Limitations included more than one-third of usual care participants received another form of subsidized housing, potentially biasing results to the null, and loss of power due to high death rates. PSH can house high-risk individuals and reduce emergent psychiatric services and shelter use. Reductions in hospitalizations may be more difficult to realize.",2020,"It decreased psychiatric ED visits and shelter use, and increased outpatient mental health care, but not medical ED visits or hospitalizations.","['chronically homeless high users of multiple systems', 'chronically homeless persons with high use of publicly funded services', '169 individuals housed by the', 'Seventy (37 treatment; 33 control) participants died', 'chronically homeless high users of county-funded services', 'chronically homeless individuals in housing', 'We enrolled 423 participants (199 intervention; 224 control']","['PSH intervention', 'PSH', 'permanent supportive housing (PSH) versus usual care', 'permanent supportive housing']","['total ED or inpatient use, or jail', 'rates of ambulatory mental health services', 'psychiatric ED visits and shelter use, and increased outpatient mental health care', 'rates of psychiatric ED visits IRR', 'service use from Santa Clara County, CA, administrative claims data for all county-funded health care, jail and shelter, and mortality']","[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319560', 'cui_str': '224'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",423.0,0.115193,"It decreased psychiatric ED visits and shelter use, and increased outpatient mental health care, but not medical ED visits or hospitalizations.","[{'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Raven', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Kushel', 'Affiliation': 'Mathematica Policy Research, Oakland, CA, USA.'}]",Health services research,['10.1111/1475-6773.13553']
2947,32976938,A multicentre randomised phase III trial comparing pembrolizumab vs single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: the European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial.,"BACKGROUND


Malignant pleural mesothelioma (MPM) is an aggressive malignancy characterized by limited treatment options and a poor prognosis. At relapse after platinum-based chemotherapy, single-agent chemotherapy is commonly used and single-arm trials of immune-checkpoint inhibitors have demonstrated encouraging activity.
PATIENTS AND METHODS


PROMISE-meso is an open-label 1:1 randomised phase III trial investigating the efficacy of pembrolizumab (200mg/Q3W) vs institutional choice single-agent chemotherapy (gemcitabine or vinorelbine) in relapsed MPM patients with progression after/on previous platinum-based chemotherapy. Patients were performance status 0-1 and unselected for PD-L1 status. At progression, patients randomised to chemotherapy were allowed to crossover to pembrolizumab. The primary endpoint was progression-free survival (PFS), assessed by blinded independent central review (BICR). Secondary endpoints were overall survival (OS), investigator assessed (IA)-PFS, objective response rate (ORR), and safety. Efficacy by PD-L1 status was investigated in exploratory analyses.
RESULTS


Between September 2017 and August 2018, 144 patients were randomised, (pembrolizumab: 73; chemotherapy: 71). At data cut-off [20/02/2019, median follow-up of 11.8 months (IQR: 9.9-14.5)], 118 BICR-PFS events were observed. No difference in BICR-PFS was detected (HR=1.06, 95%CI:0.73-1.53; p=0.76), and median BICR-PFS (95% CI) for pembrolizumab was 2.5(2.1-4.2), compared with 3.4(2.2-4.3) months for chemotherapy. A difference in ORR for pembrolizumab was identified (22%, 95%CI:13%-33%), over chemotherapy (6%,95%CI:2%-14%; p=0.004). Forty-five patients (63%) assigned to chemotherapy, received pembrolizumab at progression. With follow-up to 21 August 2019 [17.5 months: 14.8-19.7)], no difference in OS was detected between groups (HR=1.12,95%CI:0.74-1.69; p=0.59), even after adjusting for cross-over. Pembrolizumab safety was consistent with previous observations. Exploratory efficacy analyses by PD-L1 status demonstrated no improvements in ORR/PFS/OS.
CONCLUSION


This is the first randomised trial evaluating the efficacy of pembrolizumab in MPM patients progressing after/on previous platinum-based chemotherapy. In biologically unselected patients, although associated with an improved ORR, pembrolizumab improves neither PFS nor OS over single-agent chemotherapy.",2020,"No difference in BICR-PFS was detected (HR=1.06, 95%CI:0.73-1.53; p=0.76), and median BICR-PFS (95% CI) for pembrolizumab was 2.5(2.1-4.2), compared with 3.4(2.2-4.3) months for chemotherapy.","['advanced pre-treated malignant pleural mesothelioma', 'relapsed MPM patients with progression after/on previous platinum-based chemotherapy', 'MPM patients progressing after/on previous platinum-based chemotherapy', 'Between September 2017 and August 2018', '144 patients were randomised']","['pembrolizumab (200mg/Q3W) vs institutional choice single-agent chemotherapy (gemcitabine or vinorelbine', 'pembrolizumab', 'pembrolizumab: 73; chemotherapy', 'platinum-based chemotherapy, single-agent chemotherapy', 'pembrolizumab vs single-agent chemotherapy']","['118 BICR-PFS events', 'median BICR-PFS', 'ORR/PFS/OS', 'progression-free survival (PFS), assessed by blinded independent central review (BICR', 'overall survival (OS), investigator assessed (IA)-PFS, objective response rate (ORR), and safety', 'ORR for pembrolizumab', 'OS', 'BICR-PFS', 'PFS nor OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0854891', 'cui_str': 'Pleural mesothelioma malignant recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]",144.0,0.276011,"No difference in BICR-PFS was detected (HR=1.06, 95%CI:0.73-1.53; p=0.76), and median BICR-PFS (95% CI) for pembrolizumab was 2.5(2.1-4.2), compared with 3.4(2.2-4.3) months for chemotherapy.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Royal Marsden Hospital Fulham Road, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Curioni-Fontecedro', 'Affiliation': 'University Hospital Zürich, Department of Medical Oncology and Hematology, Zürich, Switzerland.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Dafni', 'Affiliation': 'National and Kapodistrian University of Athens & Frontier Science Foundation-Hellas, Athens, Greece.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Kent Oncology Centre, Maidstone, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': ""O'Brien"", 'Affiliation': 'Royal Marsden Hospital Sutton, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pope', 'Affiliation': 'Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fisher', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Spicer', 'Affiliation': ""King's College London, Guy's Hospital, London, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'University Hospital Plymouth, Plymouth, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Gilligan', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Gautschi', 'Affiliation': 'University of Berne and Cantonal Hospital Luzern and Swiss Group for Clinical Cancer Research, Switzerland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nadal', 'Affiliation': ""Catalan Institute of Oncology (ICO), L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Janthur', 'Affiliation': 'Cantonal Hospital Aarau and Swiss Group for Clinical Cancer Research, Switzerland.'}, {'ForeName': 'R López', 'Initials': 'RL', 'LastName': 'Castro', 'Affiliation': 'Hospital Clínico Universitario de Valladolid, Spain.'}, {'ForeName': 'R García', 'Initials': 'RG', 'LastName': 'Campelo', 'Affiliation': 'Hospital Teresa Herrera, La Coruña, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rusakiewicz', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois CHUV, Centre of Experimental Therapies (CTE), Department of Oncology (DO), Lausanne, Switzerland.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Letovanec', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois CHUV, Institute of Pathology, Lausanne, Switzerland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Polydoropoulou', 'Affiliation': 'Frontier Science Foundation-Hellas, Athens, Greece.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Roschitzki-Voser', 'Affiliation': 'European Thoracic Oncology Platform (ETOP), Bern, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ruepp', 'Affiliation': 'European Thoracic Oncology Platform (ETOP), Bern, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gasca-Ruchti', 'Affiliation': 'European Thoracic Oncology Platform (ETOP), Bern, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois, Department of Oncology, Lausanne, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Stahel', 'Affiliation': 'University Hospital Zürich, Department of Medical Oncology and Hematology, Zürich, Switzerland. Electronic address: rolf.stahel@usz.ch.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.09.009']
2948,32976954,The Efficacy of Brief Parent-Infant Psychotherapy for Treating Early Regulatory Disorders: A Randomized-Controlled Trial.,"OBJECTIVE


Early regulatory disorders (ERD) place considerable strain on the parent-infant relationship and are associated with high parental distress. Brief (4-session) psychodynamic-based focused parent-infant psychotherapy (fPIP) treats ERD by strengthening the quality of the parent-infant relationship. This RCT investigates the efficacy of fPIP for treating ERD compared to standard pediatric care (TAU).
METHOD


Participants were N = 154 mothers and infants from 4 to 15 months who met criteria for persistent excessive crying, sleeping disorders, feeding disorders, or regulation disorders of sensory processing and were randomly assigned to fPIP (n = 81) or TAU (n = 73). Assessments took place at baseline and at the end of treatment after 12 weeks. Primary outcomes were the infants' regulatory symptoms and remission rate. Secondary outcomes were parents' psychological distress, depression, parenting stress, maternal self-efficacy, parental reflective functioning, and observer-rated emotional availability.
RESULTS


fPIP was superior to TAU in reducing infants' overall symptoms (p = .004, η 2  = .05, CI = 0.01-0.12), night-waking disorders (p = .030, OR = 3.12, CI = 1.21-9.22), and mothers' psychological distress (p = .000, η 2  = .08, CI = 0.03-0.16) and depression (p = .002, η 2  = .06, CI = 0.02-0.13). There was a trend suggesting that fPIP led to increased maternal self-efficacy and parental reflective functioning.
CONCLUSION


Results underscore the efficacy of brief fPIP in significantly reducing symptoms in infants with ERD and their mothers. Generalizability is restricted to low psychosocial risk samples with highly distressed mothers and comorbid ERD with a predominance of night-waking disorders.",2020,"RESULTS


fPIP was superior to TAU in reducing infants' overall symptoms (p = .004, η 2  = .05, CI = 0.01-0.12), night-waking disorders (p = .030, OR = 3.12, CI = 1.21-9.22), and mothers' psychological distress (p = .000, η 2  = .08, CI = 0.03-0.16) and depression (p = .002, η 2  = .06, CI = 0.02-0.13).","['Treating Early Regulatory Disorders', 'infants with ERD and their mothers', 'Participants were N = 154 mothers and infants from 4 to 15 months who met criteria for persistent excessive crying, sleeping disorders, feeding disorders, or regulation disorders of sensory processing and were randomly assigned to fPIP (n = 81) or TAU (n = 73']","['Brief (4-session) psychodynamic-based focused parent-infant psychotherapy (fPIP', 'fPIP', 'Brief Parent-Infant Psychotherapy']","[""infants' overall symptoms"", 'night-waking disorders', ""infants' regulatory symptoms and remission rate"", 'maternal self-efficacy and parental reflective functioning', ""parents' psychological distress, depression, parenting stress, maternal self-efficacy, parental reflective functioning, and observer-rated emotional availability"", ""mothers' psychological distress"", 'depression']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0438697', 'cui_str': 'Crying, excessive'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3839606', 'cui_str': 'Parent-infant psychotherapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3839606', 'cui_str': 'Parent-infant psychotherapy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",154.0,0.0789346,"RESULTS


fPIP was superior to TAU in reducing infants' overall symptoms (p = .004, η 2  = .05, CI = 0.01-0.12), night-waking disorders (p = .030, OR = 3.12, CI = 1.21-9.22), and mothers' psychological distress (p = .000, η 2  = .08, CI = 0.03-0.16) and depression (p = .002, η 2  = .06, CI = 0.02-0.13).","[{'ForeName': 'Anna Katharina', 'Initials': 'AK', 'LastName': 'Georg', 'Affiliation': 'Institute for Psychosocial Prevention, University Hospital Heidelberg, Germany; Psychological Institute, University Heidelberg, Germany. Electronic address: anna.georg@med.uni-heidelberg.de.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Cierpka', 'Affiliation': 'Institute for Psychosocial Prevention, University Hospital Heidelberg, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Schröder-Pfeifer', 'Affiliation': 'Institute for Psychosocial Prevention, University Hospital Heidelberg, Germany; Psychological Institute, University Heidelberg, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kress', 'Affiliation': 'Institute for Psychoanalytical Child- and Adolescent Psychotherapy Heidelberg, Germany.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Taubner', 'Affiliation': 'Institute for Psychosocial Prevention, University Hospital Heidelberg, Germany.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.06.016']
2949,32977015,Effect of Retrograde Autologous Blood Priming of Cardiopulmonary Bypass on Hemodynamic Parameters and Pulmonary Mechanics in Pediatric Cardiac Surgery: A Randomized Clinical Study.,"The present study aimed to assess the impact of retrograde autologous priming (RAP) on hemodynamics and pulmonary mechanics in children subjected to cardiothoracic surgery. This prospective randomized study analyzed the clinical records of 124 children with Rachs-1 left to right lesions subjected to cardiac surgery. They comprised 64 patients in RAP group and 60 patients in the conventional priming group. The preoperative, intraoperative and postoperative data of the studied patients were reported. The outcome measures included hematocrit value, blood gases, lung mechanics parameters, transfusion needs, ICU stay, postoperative complications and mortality. Preoperatively, there were no significant differences between the studied groups regarding the demographic data, underlying lesions, laboratory data, blood gases and pulmonary mechanics parameters. Intraoperatively, RAP group patients had significantly lower amount of blood loss, less frequent need to packed RBCs transfusion and better hematocrit values when compared with the control group. Postoperatively, RAP group patients had significantly higher Hct % at ICU arrival, significantly better pulmonary mechanics parameters and significantly shorter duration on mechanical ventilation. Retrograde autologous priming in children older than 12 months subjected to cardiac surgery for Rachs-1 left to right lesions is associated with less transfusion needs and better pulmonary mechanics.",2020,"Postoperatively, RAP group patients had significantly higher Hct % at ICU arrival, significantly better pulmonary mechanics parameters and significantly shorter duration on mechanical ventilation.","['children subjected to cardiothoracic surgery', '64 patients in RAP group and 60 patients in the conventional priming group', 'Pediatric Cardiac Surgery', '124 children with Rachs-1 left to right lesions subjected to cardiac surgery', 'children older than 12 months subjected to cardiac surgery for Rachs-1 left to right lesions']","['Retrograde Autologous Blood Priming of Cardiopulmonary Bypass', 'retrograde autologous priming (RAP', 'Retrograde autologous priming']","['packed RBCs transfusion and better hematocrit values', 'demographic data, underlying lesions, laboratory data, blood gases and pulmonary mechanics parameters', 'mechanical ventilation', 'hematocrit value, blood gases, lung mechanics parameters, transfusion needs, ICU stay, postoperative complications and mortality', 'pulmonary mechanics parameters', 'Hemodynamic Parameters and Pulmonary Mechanics', 'blood loss', 'hemodynamics and pulmonary mechanics']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0439757', 'cui_str': 'Left to right'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",124.0,0.031047,"Postoperatively, RAP group patients had significantly higher Hct % at ICU arrival, significantly better pulmonary mechanics parameters and significantly shorter duration on mechanical ventilation.","[{'ForeName': 'Hamdy', 'Initials': 'H', 'LastName': 'Singab', 'Affiliation': 'Cardiothoracic Surgery Department, Ain Shams University Faculty of Medicine, Ain Shams University Hospitals, Cairo, Egypt. Electronic address: hamdi_singab@hotmail.com.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Gamal', 'Affiliation': 'Cardiothoracic Surgery Department, Ain Shams University Faculty of Medicine, Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Refaey', 'Affiliation': 'Cardiothoracic Surgery Department, Ain Shams University Faculty of Medicine, Ain Shams University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Al-Taher', 'Affiliation': 'Anesthesia and Intensive Care Department, Ain Shams University Faculty of Medicine, Ain Shams University Hospitals, Cairo, Egypt.'}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2020.09.006']
2950,32977025,Seizure threshold manipulation in electroconvulsive therapy via repetitive transcranial magnetic stimulation. A novel way of augmentation?,"INTRODUCTION


A high seizure threshold (ST) is an impeding factor in certain patients, potentially preventing a successful electroconvulsive therapy (ECT) treatment. Several pharmacological and non-pharmacological methods have been put forward to augment ECT in such patients, however, to this date, only a handful of case reports existed about the potential role of repetitive transcranial magnetic stimulation (rTMS), as an augmentation method.
OBJECTIVES


and Methods: In this randomized, double-blinded, sham controlled study, we set out to test the hypothesis of whether the application of high frequency transcranial magnetic stimulation (HF rTMS) lowers the seizure threshold for electroconvulsive therapy and whether it has an effect on other aspects of ECT treatment, such as seizure duration (SD), efficacy and safety.
RESULTS


46 patients treated for a major depressive episode, indicated for ECT, were recruited to this study. A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test). We had not observed a significant effect of TMS stimulation before ECT on seizure duration or clinical outcome. Another potentially important observation of this study is that 4 patients in the experimental group developed transient symptoms of hypomania/mania, all of which were stabilized after the combined stimulation protocol was halted spontaneously within a week, without the need to administer mood stabilizers.
CONCLUSION


It is likely that HF rTMS stimulation prior to ECT is a novel and simple way of reducing the ST, which is useful in certain groups of patients undergoing this important treatment modality.",2020,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","['46 patients treated for a major depressive episode, indicated for ECT']","['electroconvulsive therapy via repetitive transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'high frequency transcranial magnetic stimulation (HF rTMS']","['seizure duration (SD), efficacy and safety', 'seizure threshold', 'transient symptoms of hypomania/mania', 'TMS stimulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",46.0,0.0778151,"A significantly lower seizure threshold was observed in the experimental group during ECT titration, on average a decrease by 34.55%, from 34.23mC to 22.4mC, p < 0.001 (Wilcox test).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Buday', 'Affiliation': 'Department of Psychiatry, Charles University and General University Hospital in Prague. Electronic address: jozef.buday@vfn.cz.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Albrecht', 'Affiliation': 'Department of Psychiatry, Charles University and General University Hospital in Prague.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Podgorná', 'Affiliation': 'Department of Psychiatry, Charles University and General University Hospital in Prague.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mareš', 'Affiliation': 'Department of Psychiatry, Charles University and General University Hospital in Prague.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'Le', 'Affiliation': 'Department of Psychiatry, Charles University and General University Hospital in Prague.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Čapek', 'Affiliation': 'Department of Psychiatry, Charles University and General University Hospital in Prague.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mahrík', 'Affiliation': 'Institute of Clinical and Experimental Medicine.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pol', 'Affiliation': 'Institute of Clinical and Experimental Medicine.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raboch', 'Affiliation': 'Department of Psychiatry, Charles University and General University Hospital in Prague.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Anders', 'Affiliation': 'Department of Psychiatry, Charles University and General University Hospital in Prague.'}]",Brain stimulation,['10.1016/j.brs.2020.09.008']
2951,32972265,Effect of dexmedetomidine for sedation and cognitive function in patients with preoperative anxiety undergoing carotid artery stenting.,"OBJECTIVE


This study was performed to examine the effect of dexmedetomidine for intraoperative sedation and postoperative cognitive function in patients with preoperative anxiety undergoing carotid artery stenting.
METHODS


Eighty patients were randomly divided into two groups: the dexmedetomidine group and the control group. Cognitive function was assessed using the Mini-Mental State Examination (MMSE). Anxiety was evaluated using the Amsterdam Preoperative Anxiety and Information Scale. Routine monitoring indices were recorded during surgery, and cognitive function indices were recorded before drug infusion (T 0 ), 10 minutes after drug infusion (T 1 ), at the end of surgery (T 2 ), and 6 hours after surgery (T 3 ).
RESULTS


The anxiety scores were not significantly different between the two groups at T0, but they became significantly different at T 1-3 . The MMSE scores in both groups increased at 1 and 7 days postoperatively; although the increase in the dexmedetomidine group was sharper, there was no significant difference. In both groups, the MMSE scores at 1 and 7 days after surgery were not significantly different from those at 1 day before surgery.
CONCLUSION


Dexmedetomidine can improve patients' anxiety and achieve a sufficient sedation effect without causing postoperative cognitive dysfunction.",2020,"In both groups, the MMSE scores at 1 and 7 days after surgery were not significantly different from those at 1 day before surgery.
","['Eighty patients', 'patients with preoperative anxiety undergoing carotid artery stenting']","['Dexmedetomidine', 'dexmedetomidine']","['Mini-Mental State Examination (MMSE', 'anxiety scores', 'Cognitive function', 'Amsterdam Preoperative Anxiety and Information Scale', 'Anxiety', 'MMSE scores']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}]",80.0,0.0313329,"In both groups, the MMSE scores at 1 and 7 days after surgery were not significantly different from those at 1 day before surgery.
","[{'ForeName': 'Liu-Ping', 'Initials': 'LP', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Nantong University, Nantong City, Jiangsu, China.'}, {'ForeName': 'Wen-Qing', 'Initials': 'WQ', 'LastName': 'Kang', 'Affiliation': 'Department of Geriatrics, Yidu Central Hospital of Weifang, Weifang, Shandong, China.'}]",The Journal of international medical research,['10.1177/0300060520938959']
2952,32972271,Mindfulness-based program to support lifestyle modification and weight loss in infertile women: randomized controlled trial.,"OBJECTIVE


We evaluated the short-term effects of a mindfulness-based program (MBP) on weight loss through lifestyle modification in infertile women who were overweight or obese.
METHODS


The participants were randomly assigned to 8 consecutive weekly sessions of MBP plus diet or diet alone. Both groups received a customized dietary plan. Body measures were taken and a questionnaire was applied to evaluate dietary habits at baseline and three months later.
RESULTS


The study was completed by 28 women in the MBP group and 24 in the control group. Body weight decreased 1.8 kg (2.1%) in the MBP group ( p  = 0.001, follow-up vs. baseline) and 1.7 kg (1.9%) in the control group ( p  = 0.035). There was an average reduction of 2.9 cm of waist circumference in the MBP group ( p  = 0.008) and 0.3 cm in the control group ( p  = 0.633). There was a significant reduction in the daily energy intake of the women attending the MBP (mean difference -430 Kcal/day,  p =0.010) whereas no significant change was observed in the control group.
CONCLUSION


In the short term, this MBP did not affect weight loss in infertile women, but the MBP intervention contributed to reduce waist circumference, possibly due to a significant decrease in food energy intake.
TRIAL REGISTRATION NUMBER


RBR-7by76r.",2020,"Body weight decreased 1.8 kg (2.1%) in the MBP group ( p  = 0.001, follow-up vs. baseline) and 1.7 kg (1.9%) in the control group ( p  = 0.035).","['infertile women who were overweight or obese', 'infertile women', '28 women in the MBP group and 24 in the control group']","['Mindfulness-based program to support lifestyle modification', 'mindfulness-based program (MBP', 'MBP plus diet or diet\xa0alone', 'customized dietary plan']","['weight loss', 'waist circumference', 'food energy intake', 'Body weight', 'daily energy intake']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0478261,"Body weight decreased 1.8 kg (2.1%) in the MBP group ( p  = 0.001, follow-up vs. baseline) and 1.7 kg (1.9%) in the control group ( p  = 0.035).","[{'ForeName': 'Edna M', 'Initials': 'EM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Sara P C', 'Initials': 'SPC', 'LastName': 'Paiva', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Raphael P', 'Initials': 'RP', 'LastName': 'Santos', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Ana M S', 'Initials': 'AMS', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Nutrition, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Nakita A', 'Initials': 'NA', 'LastName': 'Davis', 'Affiliation': 'Department of Nutrition, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Simone F', 'Initials': 'SF', 'LastName': 'Nery', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Fernanda P', 'Initials': 'FP', 'LastName': 'Maia', 'Affiliation': 'Department of Nutrition, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Adaliene V M', 'Initials': 'AVM', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Fernando M', 'Initials': 'FM', 'LastName': 'Reis', 'Affiliation': 'Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}]",Journal of psychosomatic obstetrics and gynaecology,['10.1080/0167482X.2020.1823962']
2953,32972289,Evaluating the effect of oral clarithromycin on acute cutaneous leishmaniasis lesions compared with systemic glucantime.,"BACKGROUND AND AIM


It is widely accepted that the high prevalence of leishmaniasis, demands the search for a tolerable effective treatment with the least side effects. This study aimed to evaluate the effect of treatment with clarithromycin on regression of lesions.
MATERIALS AND METHODS


This study was performed on 20 patients with leishmaniasis referred to dermatology clinic in 2017-2018. They were divided into two groups of intervention (500 mg oral clarithromycin twice a day) and control (20 mg/kg/day systematic glucantime). Induration size of lesions was recorded.
RESULTS


We had 20 patients with acute cutaneous leishmaniasis (CL) with 45 lesions in the control group and 49 lesions in the intervention group. In the control group, the mean number of lesions was 3 ± 2.8 and 5 ± 4.3 in each person in the control and intervention group ( p =.63). The mean size of the largest diameter of lesions' induration at the beginning of the treatment was 19.81 ± 13 and 15.47 ± 15.6 mm in control and intervention group ( p =.3) which changed to 1.59 and 0 respectively in three months after the treatment ( p =.001).
CONCLUSIONS


We concluded oral clarithromycin had therapeutic effects on acute CL similar to systematic glucantime and could be considered as a safe and effective treatment option.",2020,"In the control group, the mean number of lesions was 3 ± 2.8 and 5 ± 4.3 in each person in the control and intervention group ( p =.63).","['20 patients with leishmaniasis referred to dermatology clinic in 2017-2018', '20 patients with acute cutaneous leishmaniasis (CL) with 45 lesions in the control group and 49 lesions in the intervention group']","['clarithromycin', 'oral clarithromycin']","['mean number of lesions', 'acute cutaneous leishmaniasis lesions', ""mean size of the largest diameter of lesions' induration"", 'Induration size of lesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023281', 'cui_str': 'Leishmaniasis'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3812390', 'cui_str': 'Dermatology clinic'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0023283', 'cui_str': 'Cutaneous leishmaniasis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449791', 'cui_str': 'Number of lesions'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0023283', 'cui_str': 'Cutaneous leishmaniasis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}]",20.0,0.0234942,"In the control group, the mean number of lesions was 3 ± 2.8 and 5 ± 4.3 in each person in the control and intervention group ( p =.63).","[{'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Zabolinejad', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Pouran', 'Initials': 'P', 'LastName': 'Layegh', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Abbasi Shaye', 'Affiliation': 'Clinical Research and Development Center of Akbar Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Social Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Ghanizadeh', 'Affiliation': 'Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1825612']
2954,32972311,Reflections on a personalized cognitive rehabilitation intervention: Experiences of people living with dementia and their carers participating in the GREAT trial.,"Cognitive rehabilitation for people living with early-stage dementia improves functional ability in areas targeted in the therapy, but little is known about how participants experience this intervention. This qualitative paper investigates participants' views about a cognitive rehabilitation intervention in a randomized controlled trial (the GREAT trial) and aims to help explain and interpret the findings and to inform further intervention development. Using in-depth thematic analysis, 43 semi-structured interviews (35 individual and 8 dyadic) were conducted with 25 people living with dementia and 26 family carers from three sites. The person-centred, individualized approach was valued. Some participants' views about dementia were questioned as a consequence of taking part in the therapy; they considered the effectiveness of the intervention in the context of the progressive nature of the condition. Certain participants continued to be doubtful, focussing on the inevitability of decline, rather than the possibility of reablement. Such views may have influenced engagement. The therapeutic relationship played a vital role as it was how personalized care was provided and participants' views had changed positively. Therapists engendered greater confidence and reduced anxiety and social isolation. Positive responses support personalized rehabilitative care to address the specific needs of people living with dementia.",2020,Therapists engendered greater confidence and reduced anxiety and social isolation.,"['people living with dementia and their carers participating in the GREAT trial', 'people living with early-stage dementia', '25 people living with dementia and 26 family carers from three sites', 'people living with dementia']","['personalized cognitive rehabilitation intervention', 'Cognitive rehabilitation', 'cognitive rehabilitation intervention']",['confidence and reduced anxiety and social isolation'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]",,0.0602361,Therapists engendered greater confidence and reduced anxiety and social isolation.,"[{'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Warmoth', 'Affiliation': 'Institute of Health Research, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Morgan-Trimmer', 'Affiliation': 'Institute of Health Research, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Kudlicka', 'Affiliation': 'Institute of Health Research, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Toms', 'Affiliation': 'Wales School for Social Care Research, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'James', 'Affiliation': 'Centre of the Health of the Elderly, Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Woods', 'Affiliation': 'Dementia Services Development Centre Wales, Bangor University, Bangor, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychological rehabilitation,['10.1080/09602011.2020.1820876']
2955,32972315,Dural Arteriovenous Fistulae After Cerebral Venous Thrombosis.,"BACKGROUND AND PURPOSE


This analysis examined the frequency of dural arteriovenous fistulae (dAVF) after cerebral venous thrombosis (CVT) in patients included in a randomized controlled trial comparing dabigatran etexilate with dose-adjusted warfarin (RE-SPECT CVT [A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis]), who had systematic follow-up magnetic resonance (MR) imaging.
METHODS


RE-SPECT CVT was a Phase 3, prospective, randomized, parallel-group, open-label, multicenter, exploratory trial with blinded end point adjudication. We allocated patients with acute CVT to dabigatran 150 mg twice daily or dose-adjusted warfarin, for 24 weeks and obtained a standardized MR protocol including time-of-flight MR angiography, 3-dimensionalphase-contrast venography, and 3-dimensional contrast-enhanced MR venography at the end of the treatment period. A blinded adjudication committee assessed the presence of dAVF in a predefined substudy of the trial.
RESULTS


We analyzed development of dAVF in 112 of 120 randomized patients; 57 allocated to dabigatran and 55 to warfarin. For 3 (2.7%) of these 112 patients, quality of follow-up imaging was insufficient to evaluate dAVF. A dAVF (Borden I) was found in 1 patient (0.9%) allocated to warfarin; however, this dAVF was already present at baseline. The patient did not present with hemorrhage at baseline or during the trial and was asymptomatic at follow-up.
CONCLUSIONS


Despite systematic imaging, we found no new dAVF 6 months after CVT. Routine follow-up cerebral MR angiography aiming to detect new dAVF 6 months after CVT has a very low yield.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02913326.",2020,"Routine follow-up cerebral MR angiography aiming to detect new dAVF 6 months after CVT has a very low yield.
","['112 of 120 randomized patients; 57 allocated to', 'Patients With Cerebral Venous and Dural Sinus Thrombosis']","['Dabigatran Etexilate With Warfarin', 'warfarin', 'dabigatran and 55 to warfarin', 'dabigatran etexilate with dose-adjusted warfarin (RE-SPECT CVT', 'dabigatran 150 mg twice daily or dose-adjusted warfarin, for 24 weeks and obtained a standardized MR protocol including time-of-flight MR angiography, 3-dimensionalphase-contrast venography, and 3-dimensional contrast-enhanced MR venography']","['frequency of dural arteriovenous fistulae (dAVF', 'Dural Arteriovenous Fistulae']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0010271', 'cui_str': 'Dural sinus'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]","[{'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C0151945', 'cui_str': 'Thrombosis of cerebral veins'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243032', 'cui_str': 'Magnetic resonance imaging (MRI) of vessels'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0031545', 'cui_str': 'Venography'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C1690005', 'cui_str': 'MRI venography'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}]",120.0,0.193279,"Routine follow-up cerebral MR angiography aiming to detect new dAVF 6 months after CVT has a very low yield.
","[{'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ferro', 'Affiliation': 'Serviço de Neurologia, Department of Neurosciences and Mental Health, Hospital Santa Maria/Centro Hospitalar Lisboa Norte, Portugal (J.M.F.).'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, the Netherlands (J.M.C., B.v.d.V.).'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Neuroradiology, University of Kiel, Germany (O.J.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'Neurologische Klinik, Abteilung für Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany (M.B.).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Dentali', 'Affiliation': 'Department of Medicine and Surgery, Insubria University, Varese, Italy (F.D.).'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Kobayashi', 'Affiliation': 'Faculty of Health Sciences and Physical Education, Kazimierz Pulaski University of Technology and Humanities, Radom, Poland (A.K.).'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'van der Veen', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, the Netherlands (J.M.C., B.v.d.V.).'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'HMS Analytical Software GmbH, Weimar (Lahn), Germany (C.M.).'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Caria', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim am Rhein, Germany (J.C.).'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Huisman', 'Affiliation': 'Boehringer Ingelheim B.V., Alkmaar, the Netherlands (H.H.).'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Faculty of Medicine, University Duisburg-Essen, Germany (H.-C.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.120.031235']
2956,32972404,"Comparison of different feedback modalities for the training of procedural skills in Oral and maxillofacial surgery: a blinded, randomized and controlled study.","BACKGROUND


The feedback given to students plays an important role in their efficiency related to learning practical skills. In the present study, diverse feedback modalities have been investigated. Our hypothesis is that individualized and unsupervised video feedback can produce a similar learning experience as performing practical skills in an oral and maxillofacial surgery setting with conventional direct expert feedback (control group).
METHODS


This prospective, randomized, controlled, and blinded study compared direct expert feedback (DEF), individualized video feedback (IVF) and unsupervised video feedback (UVF). The participants were fourth-year dental students from University Goethe in Frankfurt. The students were assigned to one of the three feedback methods (n = 20 per group) using simple randomization. All participants watched an instruction video for an interdental ('Ernst') ligature and periphery venous catheterization. Next, the students were video recorded performing the tasks by themselves (pre-test). Following this, every student received feedback using one of the above-mentioned feedback modalities. The participants then performed the same task again while being video recorded (post-test) to measure the acquired competence. Six weeks later, the students participated in an objective structured clinical examination (OSCE) to evaluate their long-term knowledge retention. All examiners were blinded regarding the students' instructional approach and their affiliation in terms of the learning group.
RESULTS


For the interdental ligature, we found significant improvements in performance in each feedback modality group between the pre-test and post-test (p < 0.001). UVF had the strongest effect on performance time. The comparison between each group in the post-test showed no significant differences between the three groups.
CONCLUSION


This study showed that IVF and UVF can be considered an alternative or adjunct to conventional methods (i.e. DEF) when learning procedural skills in oral and maxillofacial surgery. However, DEF showed to be the most effective method of feedback and therefore preferable in teaching.",2020,"The comparison between each group in the post-test showed no significant differences between the three groups.
","['Oral and maxillofacial surgery', 'participants were fourth-year dental students from University Goethe in Frankfurt']","['DEF', ""instruction video for an interdental ('Ernst') ligature and periphery venous catheterization"", 'IVF and UVF', 'direct expert feedback (DEF), individualized video feedback (IVF) and unsupervised video feedback (UVF']",['performance time'],"[{'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0023692', 'cui_str': 'Ligature'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0377276,"The comparison between each group in the post-test showed no significant differences between the three groups.
","[{'ForeName': 'Lukas B', 'Initials': 'LB', 'LastName': 'Seifert', 'Affiliation': 'Department of Oral, Cranio-Maxillofacial, and Facial Plastic Surgery, Goethe University Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany. lukasbenedikt.seifert@kgu.de.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Herrera-Vizcaino', 'Affiliation': 'Department of Oral, Cranio-Maxillofacial, and Facial Plastic Surgery, Goethe University Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Herguth', 'Affiliation': 'Department of Oral, Cranio-Maxillofacial, and Facial Plastic Surgery, Goethe University Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Sterz', 'Affiliation': 'Department of Trauma, Reconstructive and Hand Surgery, Goethe University Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sader', 'Affiliation': 'Department of Oral, Cranio-Maxillofacial, and Facial Plastic Surgery, Goethe University Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt, Germany.'}]",BMC medical education,['10.1186/s12909-020-02222-1']
2957,32972635,Comparison of the effects of Pueraria mirifica gel and of placebo gel on the vaginal microenvironment of postmenopausal women with Genitourinary Syndrome of Menopause (GSM).,"OBJECTIVE


To compare the effects of a 12-week course of 5%Pueraria mirifica gel and placebo gel on the prevalence of bacterial vaginosis, vaginal fungi, vaginal pH, vaginal health index (VHI), and genitourinary symptoms in postmenopausal women.
STUDY DESIGN


In a randomized, double-blinded, placebo-controlled study (TCTR20160517002), 60 postmenopausal women were randomly assigned to a 12-week course of eitherP. mirifica gel or identical placebo gel.
MAIN OUTCOME MEASURE


Vaginal Nugent score, fungal culture, pH, VHI, and genitourinary symptoms were evaluated at baseline and after 12 weeks of treatment.
RESULTS


After 12 weeks of treatment, the proportion of participants with an abnormal Nugent score in the P. mirifica and the placebo groups were 6.7 % (2/30) and 23.3 % (7/30), respectively (p =  0.006). The mean changes in Nugent scores and VHI were significantly higher in the P. mirifica group (p <  0.05). There were no significant decreases in the prevalence of symptoms between the two groups after treatment (p > 0.05).
CONCLUSION


A 12-week course of treatment with 5 % P. mirifica vaginal gel in postmenopausal women with GSM has been proved to be effective in reducing indicators of bacterial vaginosis compared with placebo gel. Nevertheless, the effect on alleviating genital symptoms was not demonstrated.",2020,"There were no significant decreases in the prevalence of symptoms between the two groups after treatment (p > 0.05).
","['60 postmenopausal women', 'postmenopausal women with GSM', 'postmenopausal women', 'postmenopausal women with Genitourinary Syndrome of Menopause (GSM']","['eitherP. mirifica gel or identical placebo gel', '5%Pueraria mirifica gel and placebo gel', 'placebo gel', 'placebo', 'Pueraria mirifica gel']","['prevalence of symptoms', 'mean changes in Nugent scores and VHI', 'alleviating genital symptoms', 'prevalence of bacterial vaginosis, vaginal fungi, vaginal pH, vaginal health index (VHI), and genitourinary symptoms', 'Vaginal Nugent score, fungal culture, pH, VHI, and genitourinary symptoms', 'abnormal Nugent score']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1300564', 'cui_str': 'g/m2'}, {'cui': 'C5192371', 'cui_str': 'Genitourinary syndrome of menopause'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0950068', 'cui_str': 'Puerariae'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0016832', 'cui_str': 'Fungi'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0426317', 'cui_str': 'Genitourinary symptoms'}, {'cui': 'C0200954', 'cui_str': 'Mycology culture'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}]",60.0,0.303347,"There were no significant decreases in the prevalence of symptoms between the two groups after treatment (p > 0.05).
","[{'ForeName': 'Chuleekorn', 'Initials': 'C', 'LastName': 'Sritonchai', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Manonai', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Electronic address: jittima.man@mahidol.ac.th.'}, {'ForeName': 'Areepan', 'Initials': 'A', 'LastName': 'Sophonsritsuk', 'Affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Wichai', 'Initials': 'W', 'LastName': 'Cherdshewasart', 'Affiliation': 'Department of Biology, Faculty of Science, Chulalongkorn University, Bangkok, Thailand.'}]",Maturitas,['10.1016/j.maturitas.2020.06.005']
2958,32972733,"Endometrial thickness after ovarian stimulation with gonadotropin, clomiphene, or letrozole for unexplained infertility, and association with treatment outcomes.","OBJECTIVE


To study the association of endometrial thickness (EMT) with live birth rates (LBR) in ovarian stimulation with intrauterine insemination (OS-IUI) treatments for unexplained infertility.
DESIGN


Prospective cohort analysis of the Reproductive Medicine Network's Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) randomized controlled trial.
SETTING


Multicenter randomized controlled trial.
PATIENTS


A total of 868 couples with unexplained infertility (n=2,459 cycles).
INTERVENTIONS


OS-IUI treatment cycles (n = 2,459) as part of the AMIGOS clinical trial.
MAIN OUTCOME MEASURES


Live birth rates; unadjusted and adjusted risk ratios (RR) for live birth by EMT category, calculated using generalized estimating equations.
RESULTS


The overall mean EMT on day of human chorionic gonadotropin administration in cycles with a live birth was significantly greater than in those without. Compared to the referent EMT group of 9 to 12 mm, the unadjusted RR for live birth for the EMT groups of ≤5 and 6-8 were 0.48 and 0.92, respectively. The test for trend indicated evidence of decreasing LBR with decreasing EMT. After adjustment for ovarian stimulation medication, a linear trend was no longer supported. Stratified analyses revealed no differences in associations by treatment group.
CONCLUSIONS


In OS-IUI for unexplained infertility, higher LBR are observed with increasing EMT; however, EMT is not significantly associated with LBR when adjusted for OS treatment type. Appreciable LBR are seen at all EMT, even those of ≤5 mm, suggesting that OS-IUI cycles should not be canceled for thin endometrium.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01044862.",2020,"Stratified analyses revealed no differences in associations by treatment group.
","['868 couples with unexplained infertility (n=2,459 cycles', 'Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) randomized controlled trial']","['intrauterine insemination (OS-IUI', 'gonadotropin, clomiphene, or letrozole', 'endometrial thickness (EMT) with live birth rates (LBR']","['unadjusted RR for live birth', 'Live birth rates; unadjusted and adjusted risk ratios (RR) for live birth by EMT category, calculated using generalized estimating equations', 'Endometrial thickness']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",868.0,0.282259,"Stratified analyses revealed no differences in associations by treatment group.
","[{'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Quaas', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, University of California-San Diego, San Diego, California; Reproductive Partners San Diego, San Diego, California. Electronic address: aquaas@health.ucsd.edu.'}, {'ForeName': 'Sarah Z', 'Initials': 'SZ', 'LastName': 'Gavrizi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Peck', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, Michigan; Department of Obstetrics and Gynecology, Augusta University, Augusta, Georgia.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Randal D', 'Initials': 'RD', 'LastName': 'Robinson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, Texas.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Casson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Vermont, Burlington, Vermont; Northeastern Reproductive Medicine, Colchester, Vermont.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Christman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan; Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville, Florida.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2020.07.030']
2959,32972758,Effect of keratorefractive surgery on choroidal thickness in anisometropic amblyopia.,"PURPOSE


To evaluate postoperative change in choroidal thickness (CT) in patients with anisometropic amblyopia undergoing keratorefractive surgery.
METHODS


Anisometropic amblyopic patients and nonamblyopic patients who underwent keratorefractive surgery were included in the study. The eyes were divided into three groups. Group 1 consisted of eyes with anisometropic amblyopia, group 2 were the nonamblyopic fellow eyes, and group 3 (control group) were nonamblyopic eyes which had undergone keratorefractive surgery. At the third postoperative month, the CT of these eyes were measured by Enhanced Depth Imaging OCT (EDI-OCT). The choroidal thickness (CT) was measured in the subfoveal area and at 500 micron intervals nasally and temporally.
RESULTS


Twenty-three anisometropic amblyopia patients with amblyopic and fellow eyes and 23 control eyes were enrolled. The mean subfoveal choroidal thickness (CT) was 387.3±168.8μm in group 1, 412.2±88.8μm in group 2 and 337.3±99μm in group 3 (P: 0.019). Group 1 and group 2 showed higher choroidal thickness (CT) in the nasal and temporal quadrants than group 3 (P: 0.03, P: 0.04). At the third postoperative month, central foveal choroidal thickness was 356.6±115.5μm in group 1, 375.1±112.5μm in group 2 and 284.4±98.9μm in group 3 (P: 0.071). Choroidal thickness (CT) in the nasal and temporal quadrants at the third postoperative month was also similar (P: 0.210, P: 0.103).
CONCLUSIONS


The macular choroid is thicker in amblyopic eyes and non-amblyopic fellow eyes than in the nonamblyopic controls. Improved fixation after refractive surgery may normalize CT.",2020,"Group 1 and group 2 showed higher choroidal thickness (CT) in the nasal and temporal quadrants than group 3 (P: 0.03, P: 0.04).","['anisometropic amblyopia', 'patients with anisometropic amblyopia undergoing keratorefractive surgery', 'Twenty-three anisometropic amblyopia patients with amblyopic and fellow eyes and 23 control eyes', 'Anisometropic amblyopic patients and nonamblyopic patients who underwent keratorefractive surgery were included in the study']","['anisometropic amblyopia', 'choroidal thickness (CT', 'nonamblyopic fellow eyes, and group 3 (control group) were nonamblyopic eyes which had undergone keratorefractive surgery', 'keratorefractive surgery']","['choroidal thickness', 'mean subfoveal choroidal thickness (CT', 'Choroidal thickness (CT', 'central foveal choroidal thickness', 'choroidal thickness (CT', 'Enhanced Depth Imaging OCT (EDI-OCT']","[{'cui': 'C0339696', 'cui_str': 'Anisometropic amblyopia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0197447', 'cui_str': 'Refractive keratoplasty'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0339696', 'cui_str': 'Anisometropic amblyopia'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0197447', 'cui_str': 'Refractive keratoplasty'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]",23.0,0.0202632,"Group 1 and group 2 showed higher choroidal thickness (CT) in the nasal and temporal quadrants than group 3 (P: 0.03, P: 0.04).","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kepez Yildiz', 'Affiliation': 'Prof Dr N Reşat-Belger Beyoğlu Eye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Z G', 'Initials': 'ZG', 'LastName': 'Erdem', 'Affiliation': 'Prof Dr N Reşat-Belger Beyoğlu Eye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Demir', 'Affiliation': 'Prof Dr N Reşat-Belger Beyoğlu Eye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey. Electronic address: dr.gkhndmr@gmail.com.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yildirim', 'Affiliation': 'Prof Dr N Reşat-Belger Beyoğlu Eye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Agca', 'Affiliation': 'Prof Dr N Reşat-Belger Beyoğlu Eye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Aygit', 'Affiliation': 'Prof Dr N Reşat-Belger Beyoğlu Eye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kandemir Besek', 'Affiliation': 'Prof Dr N Reşat-Belger Beyoğlu Eye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fazil', 'Affiliation': 'Prof Dr N Reşat-Belger Beyoğlu Eye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Demirok', 'Affiliation': 'Department of Ophthalmology, Medeniyet University School of Medicine, Istanbul, Turkey.'}]",Journal francais d'ophtalmologie,['10.1016/j.jfo.2020.02.019']
2960,32972868,Pilot of Brief Health Coaching Intervention to Improve Adherence to Positive Airway Pressure Therapy.,"BACKGROUND


Adherence to positive airway pressure (PAP) therapies is poor, particularly among low-income populations and racial minorities. This study tested a low-resource, brief telephonic health coaching intervention to improve PAP adherence.
METHODS


Post hoc analysis of a quality improvement initiative in which English- and Spanish-speaking patients from a county-based public health system were randomly assigned to receive health coaching or usual care. An unlicensed, trained health coach called patients three times to resolve barriers to adherence. A per-protocol analysis was conducted for adherence measures collected by device modem at baseline and 30 days.
RESULTS


Of 131 people for whom device data were available, 56 were randomized to health coaching and 75 to usual care. At baseline, 47.3% of patients had used their device at any time in the past 30 days, with a mean of 2 hours of use per night. At 30 days, adjusting for baseline, patients in the coaching arm were more likely than usual care patients to use their device (55.4% vs. 41.3%, p = 0.03), and they increased their use for 0.4 hours over usual care (p = 0.04).
CONCLUSION


This pilot study suggests that a low-cost intervention could be effective at improving PAP adherence, even in a population known to have poor adherence and among long-term PAP users with poor adherence. Future research may examine whether a higher-touch intervention or one using videoconferencing yields greater improvements. This promising intervention warrants further study.",2020,"At 30 days, adjusting for baseline, patients in the coaching arm were more likely than usual care patients to use their device (55.4% vs. 41.3%, p = 0.03), and they increased their use for 0.4 hours over usual care (p = 0.04).
","['131 people for whom device data were available', 'English- and Spanish-speaking patients from a county-based public health system']","['health coaching and 75 to usual care', 'telephonic health coaching intervention', 'positive airway pressure (PAP) therapies', 'health coaching or usual care', 'Brief Health Coaching Intervention']",['PAP adherence'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0681401,"At 30 days, adjusting for baseline, patients in the coaching arm were more likely than usual care patients to use their device (55.4% vs. 41.3%, p = 0.03), and they increased their use for 0.4 hours over usual care (p = 0.04).
","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Willard-Grace', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wolf', 'Affiliation': ''}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Eula', 'Initials': 'E', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Su', 'Affiliation': ''}]",Joint Commission journal on quality and patient safety,['10.1016/j.jcjq.2020.08.011']
2961,32973117,Sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer: a multi-center randomized trial (PHENIX/CSEM 010).,"BACKGROUND


There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer. It is unclear whether and when pelvic lymphadenectomy can be safely replaced by SLN biopsy alone.
PRIMARY OBJECTIVE


To comprehensively compare the oncological outcomes of SLN biopsy with pelvic lymphadenectomy in patients with and without SLN metastasis.
STUDY HYPOTHESIS


It is hypothesized that the oncological outcomes provided by SLN biopsy are non-inferior to those of pelvic lymphadenectomy in patients with clinically early-stage cervical cancer if risk-adapted adjuvant treatments are given.
TRIAL DESIGN


All eligible patients will undergo SLN biopsy at the start of surgery. The resected SLNs will be submitted for frozen section examination. and patients will be triaged into the PHENIX-I (SLN-negative) or PHENIX-II (SLN-positive) cohort. In each cohort of this trial, patients will be randomized in a 1:1 ratio into the experimental (SLN biopsy alone) or reference (pelvic lymphadenectomy) arm. Radical hysterectomy will be performed for all patients, and adjuvant treatments will be planned according to post-operative pathological factors.
MAJOR INCLUSION/EXCLUSION CRITERIA


Patients aged between 18 and 65 years with histologically confirmed, untreated stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma.
PRIMARY ENDPOINT


The primary endpoint is disease-free survival.
SAMPLE SIZE


Estimated sample sizes of 830 and 250 are required to fulfill the study objectives of PHENIX-I and II, respectively.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


As of May 2020, more than 600 eligible patients have been enrolled. Enrollment is expected to be completed by December 2022, and presentation of results is expected in 2026.
TRIAL REGISTRATION


NCT02642471.",2020,"BACKGROUND


There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer.","['early-stage cervical cancer', 'patients with clinically early-stage cervical cancer', 'All eligible patients will undergo SLN biopsy at the start of surgery', '600 eligible patients have been enrolled', 'patients with and without SLN metastasis', 'Patients aged between 18 and 65 years with histologically confirmed, untreated stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma']","['pelvic lymphadenectomy', 'Radical hysterectomy', 'Sentinel lymph node biopsy versus pelvic lymphadenectomy', 'experimental (SLN biopsy alone) or reference (pelvic lymphadenectomy', 'SLN biopsy with pelvic lymphadenectomy']",['disease-free survival'],"[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous carcinoma'}]","[{'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.17339,"BACKGROUND


There is no accepted strategy for applying sentinel lymph node (SLN) biopsy as an alternative to pelvic lymphadenectomy in cervical cancer.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Tu', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Bingna', 'Initials': 'B', 'LastName': 'Xian', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Clinical Trial Center, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Gynecologic Oncology, Anhui Provincial Cancer Hospital, Hefei, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Gynecologic Oncology, Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': ""Department of Gynecologic Oncology, Women's Hospital of Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecologic Oncology, Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Beihua', 'Initials': 'B', 'LastName': 'Kong', 'Affiliation': 'Department of Gynecology, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Gynecology, Guangdong Province Traditional Chinese Medical Hospital, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China liujih@mail.sysu.edu.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001857']
2962,32973143,Neural correlates of mindful emotion regulation in high and low ruminators.,"Depressive rumination is considered a prominent risk factor for the occurrence, severity, and duration of depressive episodes. A variety of treatment options have been developed to treat depressive rumination of which mindfulness based programs are especially promising. In the current study, we investigated the neural underpinnings of a short mindfulness intervention and mindful emotion regulation in high and low trait ruminators in an ecologically valid environment using functional near-infrared spectroscopy (fNIRS). Participants were randomly assigned to a mindfulness instruction (MT) group or an instructed thinking (IT) group. Participants in the MT group were trained to either focus their attention mindfully on their breath or their emotions, while the IT group focused their attention on the past or future. Afterwards, all participants underwent an emotion regulation paradigm in which they either watched negative or neutral movie clips. During both paradigms cortical hemodynamic changes were assessed by means of fNIRS. Participants in the MT group showed lower activity in the cognitive control network (CCN) during the focus on breath condition in comparison to the focus on emotion condition. Additionally, oxygenated hemoglobin in the MT group tended to be lower than in the IT group. Further, self-reports of emotional distress during the instruction paradigm were reduced in the MT group. During the emotion regulation paradigm, we observed reduced emotional reactivity in terms of emotional distress and avoidance in the MT group in comparison to the IT group. Furthermore, on a neural level, we observed higher CCN activity in the MT group in comparison to the IT group. We did not find any effect of rumination, neither on the intervention nor on the emotion regulation task. The results of this pilot study are discussed in light of the present literature on the neural correlates of mindfulness based interventions in rumination and emphasize the use of fNIRS to track neural changes in situ over the course of therapy.",2020,Participants in the MT group showed lower activity in the cognitive control network (CCN) during the focus on breath condition in comparison to the focus on emotion condition.,[],"['mindfulness instruction (MT) group or an instructed thinking (IT', 'emotion regulation paradigm in which they either watched negative or neutral movie clips']","['emotional reactivity', 'emotional distress and avoidance', 'CCN activity', 'emotion regulation task', 'cognitive control network (CCN', 'Depressive rumination', 'oxygenated hemoglobin', 'emotional distress', 'lower activity']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.0247818,Participants in the MT group showed lower activity in the cognitive control network (CCN) during the focus on breath condition in comparison to the focus on emotion condition.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenbaum', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tübingen, Germany. david.rosenbaum@med.uni-tuebingen.de.'}, {'ForeName': 'Agnes M', 'Initials': 'AM', 'LastName': 'Kroczek', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hudak', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development (C-MIIND), University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Rubel', 'Affiliation': 'Psychotherapy Research Lab, Psychology and Sport Sciences, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Moritz J', 'Initials': 'MJ', 'LastName': 'Maier', 'Affiliation': 'Frauenhofer IAO | Center for Responsible Research and Innovation, Berlin, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Sorg', 'Affiliation': 'Department of Psychological Sciences, University of Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Lucca', 'Initials': 'L', 'LastName': 'Weisbender', 'Affiliation': 'Department of Psychological Sciences, University of Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Goldau', 'Affiliation': 'Department of Psychological Sciences, University of Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Mennin', 'Affiliation': 'Hunter College, City University of New York, New York, NY, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fresco', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Fallgatter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Ann-Christine', 'Initials': 'AC', 'LastName': 'Ehlis', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Tuebingen, Tübingen, Germany.'}]",Scientific reports,['10.1038/s41598-020-71952-5']
2963,32973176,Phase I clinical trial repurposing all-trans retinoic acid as a stromal targeting agent for pancreatic cancer.,"Pre-clinical models have shown that targeting pancreatic stellate cells with all-trans-retinoic-acid (ATRA) reprograms pancreatic stroma to suppress pancreatic ductal adenocarcinoma (PDAC) growth. Here, in a phase Ib, dose escalation and expansion, trial for patients with advanced, unresectable PDAC (n = 27), ATRA is re-purposed as a stromal-targeting agent in combination with gemcitabine-nab-paclitaxel chemotherapy using a two-step adaptive continual re-assessment method trial design. The maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D, primary outcome) is the FDA/EMEA approved dose of gemcitabine-nab-paclitaxel along-with ATRA (45 mg/m 2  orally, days 1-15/cycle). Dose limiting toxicity (DLT) is grade 4 thrombocytopenia (n = 2). Secondary outcomes show no detriment to ATRA pharmacokinetics.. Median overall survival for RP2D treated evaluable population, is 11.7 months (95%CI 8.6-15.7 m, n = 15, locally advanced (2) and metastatic (13)). Exploratory pharmacodynamics studies including changes in diffusion-weighted (DW)-MRI measured apparent diffusion coefficient after one cycle, and, modulation of cycle-specific serum pentraxin 3 levels over various cycles indicate stromal modulation. Baseline stromal-specific retinoid transport protein (FABP5, CRABP2) expression may be predicitve of response. Re-purposing ATRA as a stromal-targeting agent with gemcitabine-nab-paclitaxel is safe and tolerable. This combination will be evaluated in a phase II randomized controlled trial for locally advanced PDAC. Clinical trial numbers: EudraCT: 2015-002662-23; NCT03307148. Trial acronym: STARPAC.",2020,"Baseline stromal-specific retinoid transport protein (FABP5, CRABP2) expression may be predicitve of response. Re-purposing ATRA as a stromal-targeting agent with gemcitabine-nab-paclitaxel is safe and tolerable.","['pancreatic cancer', 'patients with advanced, unresectable PDAC (n\u2009=\u200927), ATRA is re-purposed as a stromal-targeting agent in combination with']","['ATRA', 'gemcitabine-nab-paclitaxel chemotherapy', 'trans retinoic acid', 'gemcitabine-nab-paclitaxel']","['ATRA pharmacokinetics', 'Median overall survival']","[{'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.113681,"Baseline stromal-specific retinoid transport protein (FABP5, CRABP2) expression may be predicitve of response. Re-purposing ATRA as a stromal-targeting agent with gemcitabine-nab-paclitaxel is safe and tolerable.","[{'ForeName': 'Hemant M', 'Initials': 'HM', 'LastName': 'Kocher', 'Affiliation': 'Centre for Tumour Biology, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK. h.kocher@qmul.ac.uk.'}, {'ForeName': 'Bristi', 'Initials': 'B', 'LastName': 'Basu', 'Affiliation': ""Department of Oncology, University of Cambridge and Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital, Cambridge, CB2 0QQ, UK.""}, {'ForeName': 'Fieke E M', 'Initials': 'FEM', 'LastName': 'Froeling', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London-Hammersmith Hospital, London, W12 0HS, UK.'}, {'ForeName': 'Debashis', 'Initials': 'D', 'LastName': 'Sarker', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, King's College London, Guy's Hospital Campus, London, SE1 9RT, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Slater', 'Affiliation': 'Barts and the London HPB Centre, The Royal London Hospital, Barts Health NHS Trust, Whitechapel, London, E1 1FR, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Carlin', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, SW7 3RP, UK.'}, {'ForeName': 'Nandita M', 'Initials': 'NM', 'LastName': 'deSouza', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, SW7 3RP, UK.'}, {'ForeName': 'Katja N', 'Initials': 'KN', 'LastName': 'De Paepe', 'Affiliation': 'Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, SW7 3RP, UK.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Goulart', 'Affiliation': 'Centre for Tumour Biology, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': 'Centre for Tumour Biology, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Imrali', 'Affiliation': 'Barts Pancreas Tissue Bank, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'Barts Pancreas Tissue Bank, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pawula', 'Affiliation': 'PK/Bioanalytics Core Facility, Cancer Research UK Cambridge Institute, University of Cambridge, Li Ka Shing Centre, Robinson Way, Cambridge, CB2 0RE, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Houghton', 'Affiliation': 'PK/Bioanalytics Core Facility, Cancer Research UK Cambridge Institute, University of Cambridge, Li Ka Shing Centre, Robinson Way, Cambridge, CB2 0RE, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Lawrence', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Yathushan', 'Initials': 'Y', 'LastName': 'Yogeswaran', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Mousa', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Carike', 'Initials': 'C', 'LastName': 'Coetzee', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': 'Cancer Prevention Trials Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Prendergast', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Propper', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute-A CRUK Centre of Excellence, Queen Mary University of London, London, EC1M 6BQ, UK.'}]",Nature communications,['10.1038/s41467-020-18636-w']
2964,32973364,Convalescent plasma falls flat in first randomized trial.,,2020,,[],[],[],[],[],[],,0.0886934,,"[{'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'Sheridan', 'Affiliation': ''}]",Nature biotechnology,['10.1038/d41587-020-00020-0']
2965,32973371,Fidelity Assessment of a Social Work-Led Intervention Among Patients with Firearm Injuries.,"Purpose


To support future development and refinement of social work-led intervention programs among patients with firearm injuries and to demonstrate how a fidelity assessment can be used to adjust and refine intervention delivery in an ongoing trial.
Methods


We conducted a fidelity assessment of a randomized controlled trial of a social work-led intervention among patients with a firearm injury.
Results


We found that our study intervention was well implemented, meeting 70% of the fidelity assessment score items, however noted lower fidelity with client-based items.
Discussion


As a result of fidelity assessment findings, we refined intervention delivery to improve implementation fidelity including beginning to review cases of all patients each month, rather than focusing on patients in crisis. Our fidelity assessment process and findings offer insight into the challenges of implementing an intervention among patients with firearm injuries and highlights the value of monitoring intervention fidelity during an ongoing trial.",2020,"Methods


We conducted a fidelity assessment of a randomized controlled trial of a social work-led intervention among patients with a firearm injury.
","['patients with firearm injuries', 'Patients with Firearm Injuries', 'patients with a firearm injury']","['social work-led intervention', 'Social Work-Led Intervention']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016139', 'cui_str': 'Firearm'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0209556,"Methods


We conducted a fidelity assessment of a randomized controlled trial of a social work-led intervention among patients with a firearm injury.
","[{'ForeName': 'Vivian H', 'Initials': 'VH', 'LastName': 'Lyons', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Lina R', 'Initials': 'LR', 'LastName': 'Benson', 'Affiliation': 'The Alcohol & Drug Abuse Institute, University of Washington, Seattle, WA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Griffin', 'Affiliation': 'Firearm Injury & Policy Research Program, Harborview Injury Prevention & Research Center, University of Washington, Seattle, WA.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Floyd', 'Affiliation': 'Firearm Injury & Policy Research Program, Harborview Injury Prevention & Research Center, University of Washington, Seattle, WA.'}, {'ForeName': 'Sharon W', 'Initials': 'SW', 'LastName': 'Kiche', 'Affiliation': 'Firearm Injury & Policy Research Program, Harborview Injury Prevention & Research Center, University of Washington, Seattle, WA.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Haggerty', 'Affiliation': 'Firearm Injury & Policy Research Program, Harborview Injury Prevention & Research Center, University of Washington, Seattle, WA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Whiteside', 'Affiliation': 'Firearm Injury & Policy Research Program, Harborview Injury Prevention & Research Center, University of Washington, Seattle, WA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Conover', 'Affiliation': 'Center for the Advancement of Critical Time Intervention, Hunter College, NY.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Herman', 'Affiliation': 'Center for the Advancement of Critical Time Intervention, Hunter College, NY.'}, {'ForeName': 'Frederick P', 'Initials': 'FP', 'LastName': 'Rivara', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rowhani-Rahbar', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA.'}]",Research on social work practice,['10.1177/1049731520912002']
2966,32973429,Entraining Alpha Activity Using Visual Stimulation in Patients With Chronic Musculoskeletal Pain: A Feasibility Study.,"Entraining alpha activity with rhythmic visual, auditory, and electrical stimulation can reduce experimentally induced pain. However, evidence for alpha entrainment and pain reduction in patients with chronic pain is limited. This feasibility study investigated whether visual alpha stimulation can increase alpha power in patients with chronic musculoskeletal pain and, secondarily, if chronic pain was reduced following stimulation. In a within-subject design, 20 patients underwent 4-min periods of stimulation at 10 Hz (alpha), 7 Hz (high-theta, control), and 1 Hz (control) in a pseudo-randomized order. Patients underwent stimulation both sitting and standing and verbally rated their pain before and after each stimulation block on a 0-10 numerical rating scale. Global alpha power was significantly higher during 10 Hz compared to 1 Hz stimulation when patients were standing ( t  = -6.08,  p  < 0.001). On a more regional level, a significant increase of alpha power was found for 10 Hz stimulation in the right-middle and left-posterior region when patients were sitting. With respect to our secondary aim, no significant reduction of pain intensity and unpleasantness was found. However, only the alpha stimulation resulted in a minimal clinically important difference in at least 50% of participants for pain intensity (50%) and unpleasantness ratings (65%) in the sitting condition. This study provides initial evidence for the potential of visual stimulation as a means to enhance alpha activity in patients with chronic musculoskeletal pain. The brief period of stimulation was insufficient to reduce chronic pain significantly. This study is the first to provide evidence that a brief period of visual stimulation at alpha frequency can significantly increase alpha power in patients with chronic musculoskeletal pain. A further larger study is warranted to investigate optimal dose and individual stimulation parameters to achieve pain relief in these patients.",2020,"Global alpha power was significantly higher during 10 Hz compared to 1 Hz stimulation when patients were standing ( t  = -6.08,  ","['20 patients underwent', 'patients with chronic musculoskeletal pain', 'Patients With Chronic Musculoskeletal Pain', 'patients with chronic pain']","['rhythmic visual, auditory, and electrical stimulation', 'visual alpha stimulation', '4-min periods of stimulation at 10 Hz (alpha), 7 Hz (high-theta, control), and 1 Hz (control', 'Entraining Alpha Activity Using Visual Stimulation']","['unpleasantness ratings', 'pain intensity', 'pain relief', 'chronic pain', 'Global alpha power', 'alpha power', 'pain intensity and unpleasantness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",20.0,0.0579999,"Global alpha power was significantly higher during 10 Hz compared to 1 Hz stimulation when patients were standing ( t  = -6.08,  ","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Arendsen', 'Affiliation': 'Division of Functional and Restorative Neurosurgery, Eberhart Karls University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Henshaw', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Brown', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Sivan', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Taylor', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Nelson J', 'Initials': 'NJ', 'LastName': 'Trujillo-Barreto', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Casson', 'Affiliation': 'Department of Electrical and Electronic Engineering, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Anthony K P', 'Initials': 'AKP', 'LastName': 'Jones', 'Affiliation': 'Human Pain Research Group, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00828']
2967,32977380,Current Pharmacological Treatment Options for Central Serous Chorioretinopathy: A Review.,"Central serous chorioretinopathy (CSC) is a common cause of visual impairment in patients generally aged 20 to 60 and it is characterized by acute or chronic neurosensory detachments of the retina. Although CSC resolves spontaneously in most cases, in some patients it may cause permanent visual impairment in the working population; for this reason, several approaches, including photodynamic therapy (PDT), subthreshold micropulse laser treatment and oral mineralocorticoid receptor antagonists, have been studied as first-line treatment options for CSC. To date, half-dose PDT has provided the most encouraging results in this regard, supported by large, multicenter, randomized clinical trials such as the ""Prospective Randomized Controlled Treatment Trial for Chronic Central Serous Chorioretinopathy"" (PLACE) trial; however, the role of novel possible non-invasive treatment options is attracting interest. This review article aims to discuss the current pharmacological treatment options investigated for the management of CSC, including aspirin, ketoconazole, beta blockers, rifampicin and many others. In particular, further evidence about oral mineralocorticoid receptor antagonists, firstly seen as promising non-invasive alternatives for treating CSC, will be provided and discussed in light of the recent ""Eplerenone for chronic central serous chorioretinopathy in patients with active, previously untreated disease for more than 4 months"" (VICI) trial results, which have largely resized their role as possible first-line oral treatment options for treating CSC.",2020,Central serous chorioretinopathy (CSC) is a common cause of visual impairment in patients generally aged 20 to 60 and it is characterized by acute or chronic neurosensory detachments of the retina.,"['Central Serous Chorioretinopathy', 'patients generally aged 20 to 60 and it is characterized by acute or chronic neurosensory detachments of the retina', 'Central serous chorioretinopathy (CSC']","['aspirin, ketoconazole, beta blockers, rifampicin', 'photodynamic therapy (PDT']",[],"[{'cui': 'C0730328', 'cui_str': 'Central serous chorioretinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]",[],,0.0451578,Central serous chorioretinopathy (CSC) is a common cause of visual impairment in patients generally aged 20 to 60 and it is characterized by acute or chronic neurosensory detachments of the retina.,"[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Nicolò', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, University Eye Clinic of Genoa, 16132 Genoa, Italy.'}, {'ForeName': 'Lorenzo Ferro', 'Initials': 'LF', 'LastName': 'Desideri', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, University Eye Clinic of Genoa, 16132 Genoa, Italy.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Vagge', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, University Eye Clinic of Genoa, 16132 Genoa, Italy.'}, {'ForeName': 'Carlo Enrico', 'Initials': 'CE', 'LastName': 'Traverso', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, University Eye Clinic of Genoa, 16132 Genoa, Italy.'}]","Pharmaceuticals (Basel, Switzerland)",['10.3390/ph13100264']
2968,32977404,An Exploratory Analysis of Changes in Mental Wellbeing Following Curcumin and Fish Oil Supplementation in Middle-Aged and Older Adults.,"Curcumin has previously been shown to enhance mood in non-depressed older adults. However, observed benefits were limited to short-term supplementation (4 weeks). In a 16 week randomized, double-blind, placebo-controlled, 2 × 2 factorial design trial, we supplemented overweight or obese non-depressed adults (50-80 years) with curcumin (160 mg/day), fish oil (2000 mg docosahexaenoic acid +400 mg eicosapentaenoic acid/day), or a combination of both. Secondary outcomes included mental wellbeing measures (mood states and subjective memory complaints (SMCs)) and quality of life (QoL). Furthermore, plasma apolipoprotein E4 (APOE4) was measured to determine whether APOE4 status influences responses to fish oil. Curcumin improved vigour ( p  = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p  = 0.038). Fish oil did not affect any mood states, SMCs or QoL; however, responses to fish oil were affected by APOE4 status. In APOE4 non-carriers, fish oil increased vigour ( p  = 0.030) and reduced total mood disturbances ( p  = 0.048) compared to placebo. Improvements in mental wellbeing were correlated with increased QoL. Combining curcumin with fish oil did not result in additive effects. This exploratory analysis indicates that regular supplementation with either curcumin or fish oil (limited to APOE4 non-carriers) has the potential to improve some aspects of mental wellbeing in association with better QoL.",2020,Curcumin improved vigour ( p  = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p  = 0.038).,"['non-depressed older adults', 'supplemented overweight or obese non-depressed adults (50-80 years) with', 'Middle-Aged and Older Adults']","['Fish oil', 'curcumin', 'curcumin or fish oil', 'fish oil (2000 mg docosahexaenoic acid +400 mg eicosapentaenoic acid/day), or a combination of both', 'placebo', 'Curcumin and Fish Oil Supplementation']","['SMCs', 'total mood disturbances', 'Furthermore, plasma apolipoprotein E4 (APOE4', 'mental wellbeing', 'mood states, SMCs or QoL', 'Mental Wellbeing', 'additive effects', 'mental wellbeing measures (mood states and subjective memory complaints (SMCs)) and quality of life (QoL']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0052201', 'cui_str': 'Apolipoprotein E4'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0442796', 'cui_str': 'Additive'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]",,0.371043,Curcumin improved vigour ( p  = 0.044) compared to placebo and reduced SMCs compared to no curcumin treatment ( p  = 0.038).,"[{'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Kuszewski', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Peter R C', 'Initials': 'PRC', 'LastName': 'Howe', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Rachel H X', 'Initials': 'RHX', 'LastName': 'Wong', 'Affiliation': 'Clinical Nutrition Research Centre, School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan 2308, Australia.'}]",Nutrients,['10.3390/nu12102902']
2969,32977459,Food Addiction Is Associated with Binge Eating and Psychiatric Distress among Post-Operative Bariatric Surgery Patients and May Improve in Response to Cognitive Behavioural Therapy.,"The current study examined clinical correlates of food addiction among post-operative bariatric surgery patients, compared the clinical characteristics of patients with versus without food addiction, and examined whether a brief telephone-based cognitive behavioural therapy (Tele-CBT) intervention improves food addiction symptomatology among those with food addiction. Participants ( N  = 100) completed measures of food addiction, binge eating, depression, and anxiety 1 year following bariatric surgery, were randomized to receive either Tele-CBT or standard bariatric post-operative care, and then, repeated the measure of food addiction at 1.25 and 1.5 years following surgery. Thirteen percent of patients exceeded the cut-off for food addiction at 1 year post-surgery, and this subgroup of patients reported greater binge eating characteristics and psychiatric distress compared to patients without food addiction. Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention. These preliminary findings suggest that Tele-CBT may be helpful, at least in the short term, in improving food addiction symptomatology among some patients who do not experience remission of food addiction following bariatric surgery; however, these findings require replication in a larger sample.",2020,"Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention.","['post-operative bariatric surgery patients', 'Participants ( N  = 100) completed measures of food addiction, binge eating, depression, and anxiety 1 year following bariatric surgery']","['telephone-based cognitive behavioural therapy (Tele-CBT) intervention', 'Tele-CBT or standard bariatric post-operative care']","['binge eating characteristics and psychiatric distress', 'Binge Eating and Psychiatric Distress', 'food addiction symptomatology']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}]",,0.0444962,"Among those with food addiction, Tele-CBT was found to improve food addiction symptomatology immediately following the intervention.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cassin', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON M5B 2K3, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Leung', 'Affiliation': 'Centre for Mental Health, University Health Network, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Hawa', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wnuk', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Jackson', 'Affiliation': 'Bariatric Surgery Program, Toronto Western Hospital, Toronto, ON M5T 2S8, Canada.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Sockalingam', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON M5T 1R8, Canada.'}]",Nutrients,['10.3390/nu12102905']
2970,32977639,"Effect of a Nutrient-Rich, Food-Based Supplement Given to Rural Vietnamese Mothers Prior to or during Pregnancy on the Trajectories of Nutrient Biomarkers.","Nutrient interventions initiated after conception tend to have modest effects on maternal nutritional status and pregnancy outcomes. Thus, we compared the association between micronutrient intakes and the trajectories of their biomarkers before and during pregnancy. Data from a randomized trial of the effect of a nutrient-rich, food-based supplement given to 317 Vietnamese women prior to or during pregnancy on birth outcomes were used to assess nutrient intakes with biomarker trajectories of zinc, iron, folate, cobalamin, and vitamin A using linear mixed regression models. The circulating plasma or serum trajectories of all five micronutrients were associated to their baseline levels ( p  < 0.0001). Plasma zinc trajectories were also related to farm work ( p  = 0.024). Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p  = 0.003 and  p  = -0.037, respectively). In this population of rural Vietnamese women, nutrient intakes during pregnancy did not affect biomarker trajectories. The primary determinant of each nutrient biomarker trajectory was its respective baseline level prior to conception.",2020,"Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p  = 0.003 and  p  = -0.037, respectively).","['rural Vietnamese women', '317 Vietnamese women prior to or during pregnancy on birth outcomes', 'Rural Vietnamese Mothers Prior to or during Pregnancy on the Trajectories of Nutrient Biomarkers']","['nutrient-rich, food-based supplement', 'Nutrient-Rich, Food-Based Supplement Given']","['circulating plasma or serum trajectories', 'gestational weight gain', 'maternal nutritional status and pregnancy outcomes', 'Plasma zinc trajectories']","[{'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]",317.0,0.0269425,"Cobalamin and vitamin A trajectories were associated with gestational weight gain ( p  = 0.003 and  p  = -0.037, respectively).","[{'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Goletzke', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley, Berkeley, CA 94720, USA.'}, {'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi 100000, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley, Berkeley, CA 94720, USA.'}]",Nutrients,['10.3390/nu12102913']
2971,32973443,"Remote Microphone Hearing Aid Use Improves Classroom Listening, Without Adverse Effects on Spatial Listening and Attention Skills, in Children With Auditory Processing Disorder: A Randomised Controlled Trial.","Background


Children with Auditory Processing Disorder (APD) often have poor auditory processing skills in the presence of normal peripheral hearing. These children have worse listening-in-noise skills compared to typically developing peers, while other commonly reported symptoms include poor attention and distractibility. One of the management strategies for children with APD is the use of Remote Microphone Hearing Aids (RMHAs), which can help improve the signal-to-noise ratio in the child's ears. The aim of this randomised controlled trial was to examine whether RMHAs improved classroom listening in children with APD, and to further test their effects on children's listening-in-noise and attention skills following a 6-month intervention.
Methods


Twenty-six children diagnosed with APD, aged 7-12, in primary mainstream education, were randomised into the intervention ( N  = 13) and control group ( N  = 13). The primary outcome measure was the Listening Inventory for Education - Revised questionnaire, completed by children to assess their listening using RMHAs under several acoustically challenging situations in the classroom. Secondary outcome measures included the Listening in Spatialised Noise - Sentences test, assessing speech-in-noise perception and spatial listening, and the Test of Everyday Attention for Children, assessing different types of attention skills. Tests were conducted in unaided conditions. Mixed analysis of variance was used to analyse the data. The clinical trial was registered at clinicaltrials.gov (unique identifier: NCT02353091).
Results


The questionnaire scores of self-reported listening skills in the classroom significantly improved in the intervention group after 3,  MD  = 7.31,  SE  = 2.113,  p  = 0.014, and after 6 months,  M  = 5.00,  SE  = 1.468,  p  = 0.016. The behavioural measures of listening-in-noise and attention did not significantly change.
Conclusion


Use of RMHAs improves classroom listening, evidenced by the results of the questionnaire analysis, while a 6-month use did not have adverse effects on unaided spatial listening or attention skills.",2020,"The questionnaire scores of self-reported listening skills in the classroom significantly improved in the intervention group after 3,  MD  = 7.31,  SE  = 2.113,  p  = 0.014, and after 6 months,  M  = 5.00,  SE  = 1.468,  p  =","['\n\n\nChildren with Auditory Processing Disorder (APD', 'children with APD', 'Methods\n\n\nTwenty-six children diagnosed with APD, aged 7-12, in primary mainstream education', 'Children With Auditory Processing Disorder']","['Remote Microphone Hearing Aids (RMHAs', 'RMHAs']","['questionnaire scores of self-reported listening skills', 'Spatial Listening and Attention Skills', 'Listening in Spatialised Noise - Sentences test, assessing speech-in-noise perception and spatial listening, and the Test of Everyday Attention for Children, assessing different types of attention skills', 'classroom listening', 'Listening Inventory for Education - Revised questionnaire, completed by children to assess their listening using RMHAs under several acoustically challenging situations in the classroom']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004310', 'cui_str': 'Auditory processing disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0585653', 'cui_str': 'Test of everyday attention'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]",26.0,0.187145,"The questionnaire scores of self-reported listening skills in the classroom significantly improved in the intervention group after 3,  MD  = 7.31,  SE  = 2.113,  p  = 0.014, and after 6 months,  M  = 5.00,  SE  = 1.468,  p  =","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Stavrinos', 'Affiliation': 'Ear Institute, Faculty of Brain Sciences, University College London, London, United Kingdom.'}, {'ForeName': 'Vasiliki Vivian', 'Initials': 'VV', 'LastName': 'Iliadou', 'Affiliation': 'Neuroscience Division, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Menelaos', 'Initials': 'M', 'LastName': 'Pavlou', 'Affiliation': 'Department of Statistical Science, University College London, London, United Kingdom.'}, {'ForeName': 'Doris-Eva', 'Initials': 'DE', 'LastName': 'Bamiou', 'Affiliation': 'Ear Institute, Faculty of Brain Sciences, University College London, London, United Kingdom.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00904']
2972,32973475,Walking Time Is Associated With Hippocampal Volume in Overweight and Obese Office Workers.,"Objectives : To investigate the long-term effects on cognition and brain function after installing treadmill workstations in offices for 13 months.  Methods : Eighty healthy overweight or obese office workers aged 40-67 years were individually randomized to an intervention group, receiving a treadmill workstation and encouraging emails, or to a control group, continuing to work as usual. Effects on cognitive function, hippocampal volume, prefrontal cortex (PFC) thickness, and circulating brain-derived neurotrophic factor (BDNF) were analyzed. Further, mediation analyses between changes in walking time and light-intensity physical activity (LPA) on changes in BDNF and hippocampal volume between baseline and 13 months, and multivariate analyses of the baseline data with percentage sitting time as the response variable, were performed.  Results : No group by time interactions were observed for any of the outcomes. In the mediation analyses, positive associations between changes in walking time and LPA on changes in hippocampal volume were observed, although not mediated by changes in BDNF levels. In the multivariate analyses, a negative association between percentage sitting time and hippocampal volume was observed, however only among those older than 51 years of age.  Conclusion : Although no group by time interactions were observed, our analyses suggest that increased walking and LPA may have positive effects on hippocampal volume and that sedentary behavior is associated with brain structures of importance for memory functions.  Trial Registration : www.ClinicalTrials.gov as NCT01997970.",2020,"In the mediation analyses, positive associations between changes in walking time and LPA on changes in hippocampal volume were observed, although not mediated by changes in BDNF levels.","['offices for 13 months', 'Overweight and Obese Office Workers', 'Eighty healthy overweight or obese office workers aged 40-67 years']","['intervention group, receiving a treadmill workstation and encouraging emails, or to a control group, continuing to work as usual']","['BDNF and hippocampal volume', 'percentage sitting time and hippocampal volume', 'cognition and brain function', 'BDNF levels', 'walking time and light-intensity physical activity (LPA', 'cognitive function, hippocampal volume, prefrontal cortex (PFC) thickness, and circulating brain-derived neurotrophic factor (BDNF', 'hippocampal volume']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C1736830', 'cui_str': 'Workstation'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1096202', 'cui_str': 'Lipoprotein (a) measurement'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}]",80.0,0.0208815,"In the mediation analyses, positive associations between changes in walking time and LPA on changes in hippocampal volume were observed, although not mediated by changes in BDNF levels.","[{'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Bergman', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Matsson-Frost', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Jonasson', 'Affiliation': 'Department of Integrative Medical Biology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Chorell', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Sörlin', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Wennberg', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Öhberg', 'Affiliation': 'Department of Radiation Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Ryberg', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Levine', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Olsson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Umeå Center for Functional Brain Imaging (UFBI), Umeå University, Umeå, Sweden.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.00307']
2973,32973550,Effects of High-Intensity Resistance Training on Fitness and Fatness in Older Men With Osteosarcopenia.,"To date, there has been no study on the long-term effects of resistance exercise on sarcopenia and obesity indices for people with sarcopenia. The present study thus aimed to determine the effect of 18 months of periodized, high-velocity/intensity/effort progressive resistance training (HIT-RT) on body composition and strength in older men with osteosarcopenia. Using a single-blind, two-group parallel design, 43 community-dwelling men, 72 years and older, with osteopenia and sarcopenia in Erlangen-Nürnberg, Germany, were randomly assigned to two study arms by drawing lots: (1) an exercise group that conducted a consistently supervised periodized high-velocity/intensity/effort protocol (HIT-RT;  n  = 21) on machines twice a week for 18 months or (2) a control group (CG;  n  = 22) that maintained their physical activity/exercise habits. Both groups were supplied with protein, cholecalciferol, and calcium according to current recommendations. The study outcomes were lean body mass (LBM), total and abdominal body fat as determined by dual-energy X-ray absorptiometry and maximum hip/leg extensor strength as assessed on an isokinetic leg press at baseline and after 8, 12, and 18 months of follow-up. The intention-to-treat principle and multiple imputation were applied to calculated study outcomes. After 18 months of HIT-RT, altogether five participants were lost to follow up (HIT-RT:  n  = 2, CG:  n  = 3). The attendance rates (95%) for HIT-RT were high; relevant adverse effects were not observed. Significant effects (i.e., differences between HIT-RT vs. CG) in favor of HIT-RT were determined for LBM (+1.73 kg, 95% CI: +1.13 to +2.32 kg), total body fat mass (-2.44 kg, 95% CI: -1.28 to 3.60 kg), abdominal body fat percentage (-2.68, 95% CI: -1.70 to -3.66), and maximum hip/leg extensor strength (+533 N, 95% CI: +397 to +670 N; all  p  < 0.001). Even after adjusting for multiple testing, all effects remained significant. Of note, after 8 months of HIT-RT, only slight (LBM and fat indices) to moderate (maximum strength) ongoing effects were observed. Carefully introduced, continuously supervised HIT-RT is an effective, attractive, feasible, and safe method to improve body composition and muscle strength in older community-dwelling men with sarcopenia. However, even when consequently applying principles of exercise intensity progression within the RT protocol, only slight further positive changes were observed after 8 months of exercise.",2020,"Carefully introduced, continuously supervised HIT-RT is an effective, attractive, feasible, and safe method to improve body composition and muscle strength in older community-dwelling men with sarcopenia.","['older men with osteosarcopenia', 'older community-dwelling men with sarcopenia', 'Older Men With Osteosarcopenia', 'people with sarcopenia', '43 community-dwelling men, 72 years and older, with osteopenia and sarcopenia in Erlangen-Nürnberg, Germany']","['resistance exercise', 'High-Intensity Resistance Training', 'exercise group that conducted a consistently supervised periodized high-velocity/intensity/effort protocol (HIT-RT;  n  = 21) on machines twice a week for 18 months or (2) a control group (CG;  n  = 22) that maintained their physical activity/exercise habits', 'protein, cholecalciferol, and calcium', 'periodized, high-velocity/intensity/effort progressive resistance training (HIT-RT']","['body composition and strength', 'abdominal body fat percentage', 'lean body mass (LBM), total and abdominal body fat as determined by dual-energy X-ray absorptiometry and maximum hip/leg extensor strength as assessed on an isokinetic leg press', 'total body fat mass', 'adverse effects', 'maximum hip/leg extensor strength', 'body composition and muscle strength', 'Fitness and Fatness', 'attendance rates', 'exercise intensity progression']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",5.0,0.0433967,"Carefully introduced, continuously supervised HIT-RT is an effective, attractive, feasible, and safe method to improve body composition and muscle strength in older community-dwelling men with sarcopenia.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kohl', 'Affiliation': 'Faculty Medical and Life Sciences, University of Furtwangen, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Sports Science, University of Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Engelke', 'Affiliation': 'Department of Medicine III, Friedrich-Alexander University of Erlangen-Nürnberg, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'von Stengel', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schoene', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}]",Frontiers in physiology,['10.3389/fphys.2020.01014']
2974,32973553,Can Gaming Get You Fit?,"Rationale


Exergaming may be a viable alternative to more traditional exercise. As high-intensity exercise can provide substantial health benefits, the purpose of this study was to investigate the long-term effectiveness of providing inactive adults with access to a high-intensity exergaming platform.
Methods


In this study, 52 inactive adults (<150 min of exercise per week), aged 18 years or older, were randomized (1:1) into an exergaming ( N  = 27) or a control group ( N  = 25). Exergaming participants were given access to the Playpulse exergaming platform for 6 months, where they decided how frequently they wanted to use the platform. The primary outcome measure, analyzed with a mixed model, was peak oxygen uptake (V̇O 2peak ). Secondary outcomes included body composition, blood pressure, and blood markers of cardiometabolic health.
Results


Mean V̇O 2peak  at 6 months was 42.3 (SD 7.0) mL⋅kg -1 ⋅min -1  and 41.9 (SD 7.4) mL⋅kg -1 ⋅min -1  for the exergaming and control group, respectively with no significant between-group differences (-0.7, 95% CI -2.7 to 1.3,  P  = 0.49). Apart from increased moderate-intensity physical activity in the exergaming group at 3 months (21.9 min⋅day -1 , 95% CI: 2.2 to 41.5,  P  = 0.03) compared to the control group, there were no significant between-group differences for any outcome at either 3 or 6 months. On average, participants in the exergaming group performed 12 (SD 13) exergaming sessions with an average heart rate of 74.5 (SD 7.5)% of maximum heart rate, throughout the intervention.
Conclusion


Due to low exergaming frequency over the 6-month intervention, exergaming participants showed no significant health benefits compared to control. Our study indicates that although the Playpulse exergaming platform is found enjoyable, this is not enough to motivate inactive adults to regularly engage in exercise and thereby improve health.
Clinical Trial Registration


www.clinicaltrials.gov, identifier NCT03513380.",2020,"mL⋅kg -1 ⋅min -1  for the exergaming and control group, respectively with no significant between-group differences (-0.7, 95% CI -2.7 to 1.3,  P  = 0.49).","['52 inactive adults (<150 min of exercise per week), aged 18 years or older']",[],"['body composition, blood pressure, and blood markers of cardiometabolic health', 'peak oxygen uptake (V̇O 2peak ', 'Mean V̇O 2peak', 'moderate-intensity physical activity', 'mL⋅kg -1 ⋅min -1']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",52.0,0.134018,"mL⋅kg -1 ⋅min -1  for the exergaming and control group, respectively with no significant between-group differences (-0.7, 95% CI -2.7 to 1.3,  P  = 0.49).","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Berg', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Alf Inge', 'Initials': 'AI', 'LastName': 'Wang', 'Affiliation': 'Department of Computer Science, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Lydersen', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Moholdt', 'Affiliation': 'Department of Circulation and Medical Imaging, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Frontiers in physiology,['10.3389/fphys.2020.01017']
2975,32973615,Communication Skills and Communicative Autonomy of Prelinguistic Deaf and Hard-of-Hearing Children: Application of a Video Feedback Intervention.,"Background and Aim


Evidence on the efficacy of parenting interventions to support communication development in deaf and hard-of-hearing children is emerging. In previous research, we showed that parental participation in a video feedback-based intervention enhanced parental self-esteem and emotional availability to their deaf and hard-of-hearing children. This paper investigates the impact of the intervention on the development of the children's prelingual communication skills and autonomy. Evidence on the efficacy of parenting interventions to support communication development is warranted.
Methods


Sixteen hearing parents with a prelingual deaf and hard-of-hearing child ( M age = 2.05 years, SD = 1.77) were recruited by self-selection from pediatric audiological services and randomly stratified into intervention-first and waiting-list groups. Families completed three sessions of Video Interaction Guidance in their homes. Designed for maximal inclusion, the sample comprised children with complex developmental and social needs. The primary inclusion criterion was the child's prelingual status (<50 signed/spoken words), which was established using speech and language therapy reports. Child communicative autonomy was assessed from a 20 min free-play video recording using a gold standard measure for deaf and hard-of-hearing children (Tait) before and after the intervention.
Results


A Mann-Whitney  U  test indicated no significant difference between the two groups. The groups were collated, and a Wilcoxon signed-rank test with time (pre-/post-intervention) as a repeating variable was run. A significant increase in children's communicative autonomy ( Z  = -3.517,  p  < 0.0001,  d  = 0.62) and decrease in children's no-responses ( Z  = -3.111,  p  < 0.005,  d  = 0.55) were seen. There was no significant difference in the overall number of turn-taking between the parent and child, indicating differences in the quality of the parent-child interactions, not the quantity.
Conclusion


This study adds to the emerging evidence for parenting interventions with deaf and hard-of-hearing children. We hypothesize that the video feedback intervention with its focus on emotional availability created space for the children to show increased communicative autonomy during parent-child interactions. Communicative autonomy is a long-term predictor of communication and linguistic development in deaf and hard-of-hearing children, and its conceptual underpinning makes it a good early measure of relational agency. Results can inform wider interventions that focus on the quantity of the parent-child communication.",2020,"A significant increase in children's communicative autonomy ( Z  = -3.517,  p  < 0.0001,  d  = 0.62) and decrease in children's no-responses ( Z  = -3.111,  p  < 0.005,  d  = 0.55) were seen.","['children with complex developmental and social needs', 'hearing children', 'Prelinguistic Deaf and Hard-of-Hearing Children', 'Sixteen hearing parents with a prelingual deaf and hard-of-hearing child ( M age = 2.05 years, SD = 1.77) were recruited by self-selection from pediatric audiological services and randomly stratified into intervention-first and waiting-list groups']","['Video Interaction Guidance', 'video feedback intervention', 'Video Feedback Intervention', 'parenting interventions']","['Child communicative autonomy', 'overall number of turn-taking', ""children's communicative autonomy"", ""children's no-responses"", 'communicative autonomy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0018772', 'cui_str': 'Partial deafness'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0587540', 'cui_str': 'Audiological service'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4040951', 'cui_str': 'Video interaction guidance'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}]",16.0,0.0219958,"A significant increase in children's communicative autonomy ( Z  = -3.517,  p  < 0.0001,  d  = 0.62) and decrease in children's no-responses ( Z  = -3.111,  p  < 0.005,  d  = 0.55) were seen.","[{'ForeName': 'Meghana', 'Initials': 'M', 'LastName': 'Wadnerkar Kamble', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Lam-Cassettari', 'Affiliation': 'MARCS Institute for Brain, Behaviour & Development, Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'James', 'Affiliation': 'Education and Social Research Institute, Manchester Metropolitan University, Manchester, United Kingdom.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01983']
2976,32973638,Videoconferencing Psychotherapy for Panic Disorder and Agoraphobia: Outcome and Treatment Processes From a Non-randomized Non-inferiority Trial.,"Background


In the context of the COVID-19 pandemic, legislations are being modified around the world to allow patients to receive mental health services through telehealth. Unfortunately, there are no large clinical trial available to reliably document the efficacy of delivering videoconferencing psychotherapy (VCP) for people with panic disorder and agoraphobia (PDA) and whether basic psychotherapeutic processes are altered.
Methods


This 2-arm intent-to-treat non-inferiority study reports on a clinical trial on VCP and documents how therapeutic working alliance and motivation toward psychotherapy are associated to treatment outcome. We hypothesized that VCP would not be inferior to standard face-to-face (FF) cognitive behavior therapy for PDA. No specific hypothesis was stated to address working alliance and treatment mechanisms. VCP was compared to a gold-standard psychotherapy treatment for PDA, which was delivered either in person or in videoconference, with a strict tolerance criterion of about 2 points on the primary outcome measure. Seventy one adult patients were recruited. Measures of working alliance were collected after the first, fifth, and last session. Motivation toward therapy at pre-treatment and working alliance after the fifth therapy session were used as predictors of treatment outcome and compared with change in dysfunctional beliefs toward bodily sensations.
Results


Panic disorder, agoraphobia, fear of sensations and depressed mood all showed significant improvements and large effect-sizes from pre to post-treatment. Gains were maintained at follow-up. No significant differences were found between VCP and FF, and effect sizes were trivial for three of the four outcome measures. Non-inferiority tests confirmed that VCP was no less effective than FF therapy on the primary outcome measure and two of the three secondary outcome measures. Working alliance was very strong in VCP and did not statistically differ from FF. Working alliance and motivation did not predict treatment outcome, which was significantly predicted by the reduction in dysfunctional beliefs. The strength of the therapeutic bond was correlated with change in dysfunctional beliefs.
Conclusion


Mental health professionals can use VCP to provide services to patients with PDA. Building and maintaining a sound working alliance should not be a source concern. Practical recommendations are formulated.
ISRCTN Trial Registration Number


ISRCTN76456442.",2020,"No significant differences were found between VCP and FF, and effect sizes were trivial for three of the four outcome measures.","['people with panic disorder and agoraphobia (PDA', 'Panic Disorder and Agoraphobia', 'Seventy one adult patients were recruited', 'patients with PDA']","['videoconferencing psychotherapy (VCP', 'VCP', 'FF therapy', 'Videoconferencing Psychotherapy']","['Panic disorder, agoraphobia, fear of sensations', 'dysfunctional beliefs', 'working alliance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",71.0,0.12731,"No significant differences were found between VCP and FF, and effect sizes were trivial for three of the four outcome measures.","[{'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bouchard', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Micheline', 'Initials': 'M', 'LastName': 'Allard', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Robillard', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Dumoulin', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Guitard', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Claudie', 'Initials': 'C', 'LastName': 'Loranger', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Green-Demers', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Marchand', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Renaud', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}, {'ForeName': 'Louis-Georges', 'Initials': 'LG', 'LastName': 'Cournoyer', 'Affiliation': 'School of Criminology, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Corno', 'Affiliation': 'Cyberpsychology Lab, Université du Québec en Outaouais, Gatineau, QC, Canada.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.02164']
2977,32973641,Next-Generation Sequencing Analysis of ctDNA for the Detection of Glioma and Metastatic Brain Tumors in Adults.,"Background and aims:  The next-generation sequencing technologies and their related assessments of circulating tumor DNA in both glioma and metastatic brain tumors remain largely limited.  Methods:  Based largely on a protocol approved by the institutional review board at Peking University International Hospital, the current retrospective, single-center study was conducted. Genomic DNA was extracted from blood samples or tumor tissues. With the application of NextSeq 500 instrument (Illumina), Sequencing was performed with an average coverage of 550-fold. Paired-end sequencing was employed utilized with an attempt to achieve improved sensitivity of duplicate detection and therefore to increase the detection reliability of possible fusions.  Results:  A total of 28 patients (21 men and 7 women) with brain tumors in the present study were involved in the study. The patients enrolled were assigned into two groups, including glioma group ( n  = 21) and metastatic brain tumor group ( n  = 7). The mean age of metastatic brain tumor group (59.86 ± 8.85 y), (43.65 ± 13.05 y) reported significantly higher results in comparison to that of glioma group (45.3 ± 12.3 years) ( P  < 0.05). The mutant genes in metastatic brain tumor group included  ALK, MDM2, ATM, BRCA1, FGFR1, MDM4  and  KRAS ; however, there were no glioma-related mutant genes including  MGMT, IDH1 , IDH2,  1p/19q , and BRAF et al. Interesteringly, only two patient (28.3%) was detected blood ctDNA in metastatic brain tumor group; In contrast, blood ctDNA was found in ten glioma patients (47.6%) including 1p/19q,  MDM2, ERBB2, IDH1, CDKN2A, CDK4, PDGFRA, CCNE1, MET . The characterizations of  IDH  mutations in the glioma included  IDH1  mutation (p.R132H) and IDH2 mutation (p.R172K). The mutation rate of IDH in tumor tissues was 37.06 ± 8.32%, which was significantly higher than blood samples ( P  < 0.05).  Conclusion:  The present study demonstrated that the mutant genes among glioma and metastatic brain tumors are shown to be different. Moreover, the ctDNAs in the metastatic brain tumors included  ALK  and  MDM2 , and glioma-related ctDNAs included 1p/19q and  MDM2  followed by frequencies of  ERBB2, IDH1, CDKN2A, CDK4, PDGFRA, CCNE1, MET . These ctDNAs might be biomarkers and therapeutic responders in brain tumor.",2020,"The mutation rate of IDH in tumor tissues was 37.06 ± 8.32%, which was significantly higher than blood samples ( P  < 0.05).  ","['Glioma and Metastatic Brain Tumors in Adults', '28 patients (21 men and 7 women) with brain tumors in the present study were involved in the study']",['metastatic brain tumor group'],"['mutation rate of IDH in tumor tissues', 'ALK, MDM2, ATM, BRCA1, FGFR1, MDM4  and  KRAS ', 'blood ctDNA']","[{'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3178846', 'cui_str': 'Mutation Frequency'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0971008', 'cui_str': 'MDM2 protein, human'}, {'cui': 'C0103097', 'cui_str': 'ammonium tetrathiomolybdate'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C1527757', 'cui_str': 'FGFR1 protein, human'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}]",28.0,0.0239783,"The mutation rate of IDH in tumor tissues was 37.06 ± 8.32%, which was significantly higher than blood samples ( P  < 0.05).  ","[{'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Department of Neurosurgery, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Wanni', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, Beijing Hospital, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Changyu', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Neurosurgery, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'HaploX Biotechnology, Shenzhen, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Tongji Hospital of Tongji University, Shanghai, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Neurosurgery, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Yuanli', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurosurgery, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'HaploX Biotechnology, Shenzhen, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, China-Japan Friendship Hospital, Beijing, China.'}]",Frontiers in neurology,['10.3389/fneur.2020.00544']
2978,32973672,Using Transcranial Direct Current Stimulation to Augment the Effect of Motor Imagery-Assisted Brain-Computer Interface Training in Chronic Stroke Patients-Cortical Reorganization Considerations.,"Introduction:  Transcranial direct current stimulation (tDCS) has been shown to modulate cortical plasticity, enhance motor learning and post-stroke upper extremity motor recovery. It has also been demonstrated to facilitate activation of brain-computer interface (BCI) in stroke patients. We had previously demonstrated that BCI-assisted motor imagery (MI-BCI) can improve upper extremity impairment in chronic stroke participants. This study was carried out to investigate the effects of priming with tDCS prior to MI-BCI training in chronic stroke patients with moderate to severe upper extremity paresis and to investigate the cortical activity changes associated with training.  Methods:  This is a double-blinded randomized clinical trial. Participants were randomized to receive 10 sessions of 20-min 1 mA tDCS or sham-tDCS before MI-BCI, with the anode applied to the ipsilesional, and the cathode to the contralesional primary motor cortex (M1). Upper extremity sub-scale of the Fugl-Meyer Assessment (UE-FM) and corticospinal excitability measured by transcranial magnetic stimulation (TMS) were assessed before, after and 4 weeks after intervention.  Results:  Ten participants received real tDCS and nine received sham tDCS. UE-FM improved significantly in both groups after intervention. Of those with unrecordable motor evoked potential (MEP-) to the ipsilesional M1, significant improvement in UE-FM was found in the real-tDCS group, but not in the sham group. Resting motor threshold (RMT) of ipsilesional M1 decreased significantly after intervention in the real-tDCS group. Short intra-cortical inhibition (SICI) in the contralesional M1 was reduced significantly following intervention in the sham group. Correlation was found between baseline UE-FM score and changes in the contralesional SICI for all, as well as between changes in UE-FM and changes in contralesional RMT in the MEP- group.  Conclusion:  MI-BCI improved the motor function of the stroke-affected arm in chronic stroke patients with moderate to severe impairment. tDCS did not confer overall additional benefit although there was a trend toward greater benefit. Cortical activity changes in the contralesional M1 associated with functional improvement suggests a possible role for the contralesional M1 in stroke recovery in more severely affected patients. This has important implications in designing neuromodulatory interventions for future studies and tailoring treatment.  Clinical Trial Registration:  The study was registered at https://clinicaltrials.gov (NCT01897025).",2020,Resting motor threshold (RMT) of ipsilesional M1 decreased significantly after intervention in the real-tDCS group.,"['Chronic Stroke Patients-Cortical Reorganization Considerations', 'stroke patients', 'chronic stroke patients with moderate to severe impairment', 'chronic stroke patients with moderate to severe upper extremity paresis', 'chronic stroke participants']","['Motor Imagery-Assisted Brain-Computer Interface Training', 'Transcranial direct current stimulation (tDCS', 'BCI-assisted motor imagery (MI-BCI', 'MI-BCI', 'real tDCS and nine received sham tDCS', 'tDCS prior to MI-BCI training', 'transcranial magnetic stimulation (TMS', 'mA tDCS or sham-tDCS before MI-BCI, with the anode applied to the ipsilesional, and the cathode to the contralesional primary motor cortex (M1', 'tDCS']","['Short intra-cortical inhibition (SICI', 'Upper extremity sub-scale of the Fugl-Meyer Assessment (UE-FM) and corticospinal excitability', 'contralesional M1', 'Resting motor threshold (RMT) of ipsilesional M1', 'baseline UE-FM score and changes in the contralesional SICI', 'UE-FM']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",10.0,0.0601289,Resting motor threshold (RMT) of ipsilesional M1 decreased significantly after intervention in the real-tDCS group.,"[{'ForeName': 'Effie', 'Initials': 'E', 'LastName': 'Chew', 'Affiliation': 'Division of Neurology, Department of Medicine, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Wei-Peng', 'Initials': 'WP', 'LastName': 'Teo', 'Affiliation': 'National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tang', 'Affiliation': 'Division of Neurology, Department of Medicine, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Kai Keng', 'Initials': 'KK', 'LastName': 'Ang', 'Affiliation': 'Institute for Infocomm Research (I2R), ASTAR, Singapore, Singapore.'}, {'ForeName': 'Yee Sien', 'Initials': 'YS', 'LastName': 'Ng', 'Affiliation': 'Department of Rehabilitation Medicine, Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Juan Helen', 'Initials': 'JH', 'LastName': 'Zhou', 'Affiliation': 'Center for Sleep and Cognition, Center for Translational MR Research, Yong Loo Lin School of Medicine, Singapore, Singapore.'}, {'ForeName': 'Irvin', 'Initials': 'I', 'LastName': 'Teh', 'Affiliation': 'School of Medicine, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Kok Soon', 'Initials': 'KS', 'LastName': 'Phua', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Melbourne, VIC, Australia.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Division of Neurology, Department of Medicine, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'Cuntai', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'School of Computer Science and Engineering, Nanyang Technological University, Singapore, Singapore.'}]",Frontiers in neurology,['10.3389/fneur.2020.00948']
2979,32973912,Anthocyanins increase serum adiponectin in newly diagnosed diabetes but not in prediabetes: a randomized controlled trial.,"Background


Epidemiological studies have suggested that adiponectin is associated with the development of insulin resistance and type 2 diabetes. This study first examined the effect of purified anthocyanins, a group of dietary flavonoids, on serum adiponectin in patients with prediabetes and newly diagnosed diabetes.
Methods


A total of 160 patients with prediabetes (n = 90) or newly diagnosed diabetes (n = 70) were randomly assigned to either the anthocyanins group or the placebo group for 12 weeks of intervention. Serum adiponectin, a set of biomarkers related to glucolipid metabolism, anthropometric parameters, dietary intake and physical activity were measured before and after intervention.
Results


Anthocyanins increased serum adiponectin compared with placebo (net change 0.46 µg/mL, 95% CI [0.03, 0.90],  p  = 0.038) in the subjects with newly diagnosed diabetes. No significant difference in the change in adiponectin was observed between the two groups either in the overall subjects (0.02 µg/mL [- 0.32, 0.36],  p  = 0.906) or in prediabetes (- 0.35 µg/mL [- 0.85, 0.16],  p  = 0.174). Anthocyanins also decreased fasting glucose (- 0.5 mmol/L [- 1, - 0.04],  p  = 0.035) in the subjects with newly diagnosed diabetes, but no such change was observed in those with prediabetes.
Conclusions


Anthocyanins supplementation for 12 weeks improved serum adiponectin and fasting glucose in patients with newly diagnosed diabetes, but not in patients with prediabetes.
Trial registration


ClinicalTrials.gov, NCT02689765. Registered on 6 February 2016, https://clinicaltrials.gov/ct2/show/NCT02689765.",2020,"Results


Anthocyanins increased serum adiponectin compared with placebo (net change 0.46 µg/mL, 95% CI [0.03, 0.90],  p  = 0.038) in the subjects with newly diagnosed diabetes.","['patients with prediabetes and newly diagnosed diabetes', '160 patients with prediabetes (n\u2009=\u200990) or newly diagnosed diabetes (n\u2009=\u200970', 'subjects with newly diagnosed diabetes', 'newly diagnosed diabetes', 'patients with newly diagnosed diabetes']","['purified anthocyanins, a group of dietary flavonoids', 'placebo', 'anthocyanins group or the placebo', 'Anthocyanins']","['serum adiponectin and fasting glucose', 'change in adiponectin', 'Serum adiponectin', 'glucolipid metabolism, anthropometric parameters, dietary intake and physical activity', 'serum adiponectin', 'fasting glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C1320655', 'cui_str': 'Newly diagnosed diabetes'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",160.0,0.0849631,"Results


Anthocyanins increased serum adiponectin compared with placebo (net change 0.46 µg/mL, 95% CI [0.03, 0.90],  p  = 0.038) in the subjects with newly diagnosed diabetes.","[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Center for Chronic Disease Control, NanShan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': ""Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': ""Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Center for Chronic Disease Control, NanShan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Center for Chronic Disease Control, NanShan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Center for Chronic Disease Control, NanShan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Center for Chronic Disease Control, NanShan, Shenzhen, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Center for Chronic Disease Control, NanShan, Shenzhen, People's Republic of China.""}]",Nutrition & metabolism,['10.1186/s12986-020-00498-0']
2980,32973944,The clinical safety and efficacy of flexible bronchoscopy in a neonatal intensive care unit.,"Flexible bronchoscopy (FB), developed in the 1960s, is widely used in the clinical practice of pediatrics and has demonstrated fundamental value in clinical diagnoses and treatment. However, as an invasive procedure, the use of FB is limited due to concerns regarding the tolerance of the procedure and the possible complications in neonatal units. Thus, the present study aimed to investigate the clinical safety and efficacy of flexible bronchoscopy (FB) in a neonatal intensive care unit (NICU). Neonates (n=54) who received FB in the NICU of Shanghai Children's Hospital between January 2012 and December 2016 were enrolled as the experimental group and another 54 neonates who required nebulization and tracheal secretion suction treatments were the control group. Indicators including blood gas, complete blood count, C-reactive protein (CRP), X-ray, patient breathing rate, temperature and blood pressure were monitored prior to and following the procedure. No significant differences in sex, gestational age, birth weight or postnatal age were observed between the experimental group and the control group (P>0.05). Among the 54 FB patients, several cases with side effect were identified, including 18 (33.3%) with respiratory tract stenosis, nine (16.7%) with malacia and stenosis and six (11.1%) with esophagotracheal fistula. Among the 54 members of the control group, 44 neonates (81.4%) were discharged with improved condition, five (9.3%) succumbed and five patients (9.3%) abandoned the treatment and left the hospital. Bronchoalveolar lavage demonstrated consistent results with respiratory secretion culture or tracheal tube culture. In comparison between the experimental and the control groups, no significant difference in pH, partial pressure of carbon dioxide (PCO 2 ), partial pressure of oxygen (PO 2 ) and HCO 3   -  was observed, while there were no statistical differences in the values of pH, PCO 2  and HCO 3   -  (P>0.05). However, PO 2  was significantly increased, and CRP was significantly reduced, following FB procedure compared with prior to FB (P<0.05). No pneumothorax, shock, other severe complications, fever or diffused pneumonia were observed during or after FB. The data from the present study demonstrated that FB is a safe and effective strategy for the diagnosis and differentiation of neonatal respiratory diseases in NICU.",2020,"No significant differences in sex, gestational age, birth weight or postnatal age were observed between the experimental group and the control group (P>0.05).","[""Neonates (n=54) who received FB in the NICU of Shanghai Children's Hospital between January 2012 and December 2016 were enrolled as the experimental group and another 54 neonates who required nebulization and tracheal secretion suction treatments were the control group"", 'neonatal intensive care unit']","['flexible bronchoscopy', 'FB', 'flexible bronchoscopy (FB', 'Flexible bronchoscopy (FB']","['pH, partial pressure of carbon dioxide (PCO 2 ), partial pressure of oxygen (PO 2 ) and HCO 3   ', 'CRP', 'sex, gestational age, birth weight or postnatal age', 'blood gas, complete blood count, C-reactive protein (CRP), X-ray, patient breathing rate, temperature and blood pressure', 'clinical safety and efficacy', 'No pneumothorax, shock, other severe complications, fever or diffused pneumonia']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}]","[{'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",,0.0214749,"No significant differences in sex, gestational age, birth weight or postnatal age were observed between the experimental group and the control group (P>0.05).","[{'ForeName': 'Chongbing', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': ""Department of Neonatology, Shanghai Children's Hospital, Shanghai 200062, P.R. China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Neonatology, Shanghai Children's Hospital, Shanghai 200062, P.R. China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Qiu', 'Affiliation': ""Department of Neonatology, Shanghai Children's Hospital, Shanghai 200062, P.R. China.""}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': ""Department of Neonatology, Shanghai Children's Hospital, Shanghai 200062, P.R. China.""}, {'ForeName': 'Dermyshi', 'Initials': 'D', 'LastName': 'Elda', 'Affiliation': ""Department of Neonatology, Shanghai Children's Hospital, Shanghai 200062, P.R. China.""}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9223']
2981,32973956,Patterns of recurrence in patients with curative resected rectal cancer according to different chemoradiotherapy strategies: Does preoperative chemoradiotherapy lower the risk of peritoneal recurrence?,"The present study aimed to compare the pattern of distant recurrence between patients with non-metastatic rectal cancer treated with pre-operative (OP) and those treated with post-operative (post-OP) chemoradiotherapy (CRT). A total of 631 patients with newly diagnosed non-metastatic rectal cancer who had received pre-OP or post-OP CRT with curative intent surgery between August 2008 and April 2015 were identified. Inverse probability of treatment weighting (IPTW) was performed to account for baseline differences between the two arms. Overall, 449 and 182 patients were treated with pre-OP and post-OP CRT, respectively. Sex, tumor location, clinical tumor stage, CRT regimen and adjuvant chemotherapy regimen were significantly different between the two arms. The median follow-up duration was 55.4 months (range, 53.7-57.1). The 5-year distant recurrence-free survival (RFS) rates and 5-year overall survival (OS) rates were not significantly different between the pre-OP and post-OP CRT arms (RFS, 67.5 vs. 71.6%, P=0.595 and OS, 81.9 vs. 77.0%, P=0.449), and no difference was observed in the distant recurrence patterns. Following IPTW, there was still no difference in distant RFS (pre-OP vs. post-OP CRT; hazard ratio (HR)=0.62; P=0.911), but pre-OP CRT was significantly associated with lower peritoneal recurrence (pre-OP vs. post-OP CRT; HR, 0.13; P=0.032). In addition, there was no significant difference in OS between the two arms (pre-OP vs. post-OP CRT; HR, 0.85; P=0.665). In conclusion, although distant RFS was not significantly different between the two arms, pre-OP CRT was significantly associated with a lower risk of peritoneal recurrence than post-OP CRT in patients non-metastatic rectal cancer.",2020,"Following IPTW, there was still no difference in distant RFS (pre-OP vs. post-OP CRT; hazard ratio (HR)=0.62; P=0.911), but pre-OP CRT was significantly associated with lower peritoneal recurrence (pre-OP vs. post-OP CRT; HR, 0.13; P=0.032).","['631 patients with newly diagnosed non-metastatic rectal cancer who had received pre-OP or post-OP CRT with curative intent surgery between August 2008 and April 2015 were identified', 'patients with curative resected rectal cancer', 'patients with non-metastatic rectal cancer treated with', 'patients non-metastatic rectal cancer']","['preoperative chemoradiotherapy', 'pre-operative (OP) and those treated with post-operative (post-OP) chemoradiotherapy (CRT', 'OP CRT']","['Inverse probability of treatment weighting (IPTW', '5-year distant recurrence-free survival (RFS) rates and 5-year overall survival (OS) rates', 'distant recurrence', 'distant recurrence patterns', 'peritoneal recurrence', 'OS', 'distant RFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0346975', 'cui_str': 'Secondary malignant neoplasm of rectum'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}]",631.0,0.144248,"Following IPTW, there was still no difference in distant RFS (pre-OP vs. post-OP CRT; hazard ratio (HR)=0.62; P=0.911), but pre-OP CRT was significantly associated with lower peritoneal recurrence (pre-OP vs. post-OP CRT; HR, 0.13; P=0.032).","[{'ForeName': 'Hyungwoo', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.'}, {'ForeName': 'Jeong Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.'}, {'ForeName': 'Kyu-Pyo', 'Initials': 'KP', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.'}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.'}, {'ForeName': 'Jin-Hong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.'}, {'ForeName': 'Jong Hoon', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.'}, {'ForeName': 'Seok-Byung', 'Initials': 'SB', 'LastName': 'Lim', 'Affiliation': 'Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.'}, {'ForeName': 'Chang Sik', 'Initials': 'CS', 'LastName': 'Yu', 'Affiliation': 'Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.'}, {'ForeName': 'Jin Cheon', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.'}, {'ForeName': 'Yong Sang', 'Initials': 'YS', 'LastName': 'Hong', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.'}]",Oncology letters,['10.3892/ol.2020.12105']
2982,32973982,Memory training combined with 3D visuospatial stimulus improves cognitive performance in the elderly: pilot study.,"Studies suggest that the engagement of aged participants in cognitive stimulation programs can reduce expected cognitive decline associated with age.
Objective


To evaluate the effects of memory training (MT) associated with three-dimensional multiple object tracking (3D-MOT) NeuroTracker (NT) in the elderly.
Methods


Forty-four participants (>60 years of age) were recruited and randomly distributed into two groups: experimental (EG; n=22) and comparative (CG; n=22). Both groups performed 12 one-hour MT sessions, twice a week, consisting of specific computerized stimuli associated with teaching of mnemonic strategies; 10 minutes of NT was part only of the EG's sessions. In pre- and post-training periods, both groups were evaluated using a sociodemographic questionnaire, neuropsychological assessment, as well as a specific measure offered by NT.
Results


Both groups benefited from the MT and reported more positive feelings regarding their memory and quality of life. However, the EG obtained better results in tests consistent with the strategies trained and which involved attentional resources, reaction time, visual processing speed, episodic, semantic, subjective and working memory as well as aspects of social cognition.
Conclusions


This study showed that the combination of MT and 3D-MOT contributed for a better cognitive performance in the EG. Thus, the results of the present study encourage further research and the development of combined cognitive interventions for the elderly population with and without cognitive deficits.",2020,"However, the EG obtained better results in tests consistent with the strategies trained and which involved attentional resources, reaction time, visual processing speed, episodic, semantic, subjective and working memory as well as aspects of social cognition.
","['elderly population with and without cognitive deficits', 'the elderly', 'Methods\n\n\nForty-four participants (>60 years of age']","['MT and 3D-MOT', 'Memory training combined with 3D visuospatial stimulus', 'memory training (MT) associated with three-dimensional multiple object tracking (3D-MOT) NeuroTracker (NT']","['attentional resources, reaction time, visual processing speed, episodic, semantic, subjective and working memory as well as aspects of social cognition', 'cognitive performance', 'positive feelings regarding their memory and quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0729377', 'cui_str': 'Memory skills training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0589087', 'cui_str': 'Visual processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",44.0,0.022594,"However, the EG obtained better results in tests consistent with the strategies trained and which involved attentional resources, reaction time, visual processing speed, episodic, semantic, subjective and working memory as well as aspects of social cognition.
","[{'ForeName': 'Mariana Medeiros', 'Initials': 'MM', 'LastName': 'Assed', 'Affiliation': 'Neuropsychology Unit, Institute and Department of Psychiatry, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Cristiana Castanho de Almeida', 'Initials': 'CCA', 'LastName': 'Rocca', 'Affiliation': 'Neuropsychology Unit, Institute and Department of Psychiatry, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Yolanda Maria', 'Initials': 'YM', 'LastName': 'Garcia', 'Affiliation': 'Department of Geriatrics, Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Tatiana Cohab', 'Initials': 'TC', 'LastName': 'Khafif', 'Affiliation': 'Neuropsychology Unit, Institute and Department of Psychiatry, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Gabriel Okawa', 'Initials': 'GO', 'LastName': 'Belizario', 'Affiliation': 'Neuropsychology Unit, Institute and Department of Psychiatry, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Toschi-Dias', 'Affiliation': 'Health Psychology Program, Universidade Metodista São Paulo, São Bernardo do Campo, SP, Brazil.'}, {'ForeName': 'Antonio de Pádua', 'Initials': 'AP', 'LastName': 'Serafim', 'Affiliation': 'Neuropsychology Unit, Institute and Department of Psychiatry, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.'}]",Dementia & neuropsychologia,['10.1590/1980-57642020dn14-030010']
2983,32974672,In-vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: a randomized non-inferiority controlled trial.,"STUDY QUESTION


Is one cycle of IVM non-inferior to one cycle of conventional in IVF with respect to live birth rates in women with high antral follicle counts (AFCs)?
SUMMARY ANSWER


We could not demonstrate non-inferiority of IVM compared with IVF.
WHAT IS KNOWN ALREADY


IVF with ovarian hyperstimulation has limitations in some subgroups of women at high risk of ovarian stimulation, such as those with polycystic ovary syndrome. IVM is an alternative ART for these women. IVM may be a feasible alternative to IVF in women with a high AFC, but there is a lack of data from randomized clinical trials comparing IVM with IVF in women at high risk of ovarian hyperstimulation syndrome.
STUDY DESIGN, SIZE, DURATION


This single-center, randomized, controlled non-inferiority trial was conducted at an academic infertility center in Vietnam from January 2018 to April 2019.
PARTICIPANTS/MATERIALS, SETTING, METHODS


In total, 546 women with an indication for ART and a high AFC (≥24 follicles in both ovaries) were randomized to the IVM (n = 273) group or the IVF (n = 273) group; each underwent one cycle of IVM with a prematuration step versus one cycle of IVF using a standard gonadotropin-releasing hormone antagonist protocol with gonadotropin-releasing hormone agonist triggering. The primary endpoint was live birth rate after the first embryo transfer. The non-inferiority margin for IVM versus IVF was -10%.
MAIN RESULTS AND THE ROLE OF CHANCE


Live birth after the first embryo transfer occurred in 96 women (35.2%) in the IVM group and 118 women (43.2%) in the IVF group (absolute risk difference -8.1%; 95% confidence interval (CI) -16.6%, 0.5%). Cumulative ongoing pregnancy rates at 12 months after randomization were 44.0% in the IVM group and 62.6% in the IVF group (absolute risk difference -18.7%; 95% CI -27.3%, -10.1%). Ovarian hyperstimulation syndrome did not occur in the IVM group, versus two cases in the IVF group. There were no statistically significant differences between the IVM and IVF groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications.
LIMITATIONS, REASONS FOR CAUTION


The main limitation of the study was its open-label design. In addition, the findings are only applicable to IVM conducted using the prematuration step protocol used in this study. Finally, the single ethnicity population limits the external generalizability of the findings.
WIDER IMPLICATIONS OF THE FINDINGS


Our randomized clinical trial compares live birth rates after IVM and IVF. Although IVM is a viable and safe alternative to IVF that may be suitable for some women seeking a mild ART approach, the current study findings approach inferiority for IVM compared with IVF when cumulative outcomes are considered. Future research should incorporate multiple cycles of IVM in the study design to estimate cumulative fertility outcomes and better inform clinical decision-making.
STUDY FUNDING/COMPETING INTEREST(S)


This work was partly supported by Ferring grant number 000323 and funded by the Vietnam National Foundation for Science and Technology Development (NAFOSTED) and by the Fund for Research Flanders (FWO). LNV has received speaker and conference fees from Merck, grant, speaker and conference fees from Merck Sharpe and Dohme, and speaker, conference and scientific board fees from Ferring; TMH has received speaker fees from Merck, Merck Sharp and Dohme, and Ferring; RJN has received conference and scientific board fees from Ferring, is a minor shareholder in an IVF company, and receives grant funding from the National Health and Medical Research Council (NHMRC) of Australia; BWM has acted as a paid consultant to Merck, ObsEva and Guerbet, and is the recipient of grant money from an NHMRC Investigator Grant; RBG reports grants and fellowships from the NHMRC of Australia; JS reports lecture fees from Ferring Pharmaceuticals, Biomérieux, Besins Female Healthcare and Merck, grants from Fund for Research Flanders (FWO), and is co-inventor on granted patents on CAPA-IVM methodology in the US (US10392601B2) and Europe (EP3234112B1); TDP, VQD, VNAH, NHG, AHL, THP and RW have no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work.
TRIAL REGISTRATION NUMBER


NCT03405701 (www.clinicaltrials.gov).
TRIAL REGISTRATION DATE


16 January 2018.
DATE OF FIRST PATENT’S ENROLMENT


25 January 2018.",2020,"There were no statistically significant differences between the IVM and IVF groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications.
","['16 January 2018', 'academic infertility center in Vietnam from January 2018 to April 2019', 'women with a high AFC', 'women with infertility and a high antral follicle count', 'women with high antral follicle counts (AFCs', '546 women with an indication for ART and a high AFC (≥24 follicles in both ovaries']","['conventional IVF', 'IVM and IVF', 'IVM with a prematuration step versus one cycle of IVF using a standard gonadotropin-releasing hormone antagonist protocol with gonadotropin-releasing hormone agonist triggering', 'IVF', 'IVM', 'IVF with ovarian hyperstimulation', 'LNV']","['live birth rate after the first embryo transfer', 'Cumulative ongoing pregnancy rates', 'Live birth', 'occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications', 'Ovarian hyperstimulation syndrome']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0227898', 'cui_str': 'Both ovaries'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0596795', 'cui_str': 'In Vivo Microscopy'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0549383', 'cui_str': 'Hyperstimulation of ovaries'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032962', 'cui_str': 'Complication of pregnancy'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}]",546.0,0.265161,"There were no statistically significant differences between the IVM and IVF groups with respect to the occurrence of pregnancy complications, obstetric and perinatal complications, preterm delivery, birth weight and neonatal complications.
","[{'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu N A', 'Initials': 'VNA', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tuong M', 'Initials': 'TM', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vinh Q', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Phung', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nhu H', 'Initials': 'NH', 'LastName': 'Giang', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Anh H', 'Initials': 'AH', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Toan D', 'Initials': 'TD', 'LastName': 'Pham', 'Affiliation': 'IVFMD, My Duc Hospital and HOPE Research Center, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Smitz', 'Affiliation': 'Follicle Biology Laboratory, Free University of Brussels (VUB), Brussels, Belgium.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Gilchrist', 'Affiliation': ""School of Women's and Children's Health, University of New South Wales Sydney, New South Wales, Australia.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa240']
2984,32974689,Combining high-intensity focused ultrasound (HIFU) ablation with percutaneous ethanol injection (PEI) in the treatment of benign thyroid nodules.,"OBJECTIVE


Assessing the 6-month efficacy of combined high-intensity focused ultrasound (HIFU) ablation with percutaneous ethanol injection (PEI) in benign thyroid nodules by comparing it with HIFU ablation alone.
METHODS


One hundred and eighty-one (55.2%) patients underwent HIFU alone (group I) while 147 (44.8%) underwent concomitant HIFU and PEI treatment for solid or predominantly solid nodules (group II). Intravenous sedation and analgesia were given before the start of treatment. Extent of nodule shrinkage (by volume reduction ratio (VRR)), pain scores (by 0-10 visual analogue scale) during and after ablation, and rate of vocal cord palsy (VCP), skin burn, and nausea/vomiting were compared between the two groups.
RESULTS


The mean amount of ethanol injected in group II was 1.3 ± 0.7 ml. The 3- and 6-month VRR were significantly greater in group II (60.41 ± 20.49% vs. 50.13 ± 21.06%, p = 0.001; and 71.08 ± 21.25% vs. 61.37 ± 22.76%, p = 0.001, respectively), and ""on-beam"" treatment time was significantly shorter in group II (26.55 min vs. 30.26 min, p = 0.001). Group II patients reported significantly lower pain score during treatment (2.24 ± 3.07 vs. 4.97 ± 3.21, p < 0.001) and 2 h after treatment (2.23 ± 2.50 vs. 2.97 ± 4.39, p = 0.044). Rates of VCP, skin burn, and nausea or vomiting were not significantly different (p > 0.05).
CONCLUSIONS


The combined HIFU and PEI approach with improved administration of intravenous sedation and analgesia was associated with a significantly better 6-month efficacy than HIFU alone in benign thyroid nodules without compromising the safety and comfort of patients.
KEY POINTS


• Concomitant HIFU and PEI have a better treatment efficacy than HIFU alone. • Concomitant HIFU and PEI have a comparable safety profile as HIFU alone.",2020,"Rates of VCP, skin burn, and nausea or vomiting were not significantly different (p > 0.05).
","['benign thyroid nodules', 'One hundred and eighty-one (55.2']","['Combining high-intensity focused ultrasound (HIFU) ablation with percutaneous ethanol injection (PEI', 'combined high-intensity focused ultrasound (HIFU) ablation with percutaneous ethanol injection (PEI', 'concomitant HIFU and PEI treatment for solid or predominantly solid nodules', 'HIFU ablation alone', 'HIFU alone']","['on-beam"" treatment time', '3- and 6-month VRR', 'nodule shrinkage (by volume reduction ratio (VRR)), pain scores (by 0-10 visual analogue scale) during and after ablation, and rate of vocal cord palsy (VCP), skin burn, and nausea/vomiting', 'mean amount of ethanol', 'Rates of VCP, skin burn, and nausea or vomiting', 'pain score']","[{'cui': 'C0749467', 'cui_str': 'Benign thyroid nodule'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441583', 'cui_str': 'High intensity focused ultrasound'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C4307245', 'cui_str': 'Ethanol Injection'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C2348970', 'cui_str': 'High intensity focused ultrasound ablation'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0042928', 'cui_str': 'Vocal cord paralysis'}, {'cui': 'C0565944', 'cui_str': 'Burn of skin of body region'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.0356299,"Rates of VCP, skin burn, and nausea or vomiting were not significantly different (p > 0.05).
","[{'ForeName': 'Brian H H', 'Initials': 'BHH', 'LastName': 'Lang', 'Affiliation': 'Department of Surgery, The University of Hong Kong, Hong Kong SAR, China. blang@hku.hk.'}, {'ForeName': 'Yu-Cho', 'Initials': 'YC', 'LastName': 'Woo', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Keith Wan-Hang', 'Initials': 'KW', 'LastName': 'Chiu', 'Affiliation': 'Department of Radiology, The University of Hong Kong, Hong Kong SAR, China.'}]",European radiology,['10.1007/s00330-020-07317-3']
2985,32974732,"Apararenone in patients with diabetic nephropathy: results of a randomized, double-blind, placebo-controlled phase 2 dose-response study and open-label extension study.","BACKGROUND


We investigated the efficacy and safety of apararenone (MT-3995), a non-steroidal compound with mineralocorticoid receptor agonist activity, in patients with stage 2 diabetic nephropathy (DN).
METHODS


The study had two parts: a dose-response, parallel-group, randomized, double-blind, placebo-controlled, multicenter, phase 2, 24-week study and an open-label, uncontrolled, 28-week extension study. Primary and secondary endpoints were the 24-week percent change from baseline in urine albumin to creatine ratio (UACR) and 24- and 52-week UACR remission rates. Safety parameters were changes from baseline in estimated glomerular filtration rate (eGFR) and serum potassium at 24 and 52 weeks, and incidences of adverse events (AEs) and adverse drug reactions (ADRs).
RESULTS


In the dose-response period, 73 patients received placebo and 73, 74, and 73 received apararenone 2.5 mg, 5 mg, and 10 mg, respectively. As a percentage of baseline, mean UACR decreased to 62.9%, 50.8%, and 46.5% in the 2.5 mg, 5 mg, and 10 mg apararenone groups, respectively, at week 24 (placebo: 113.7% at week 24; all P < 0.001 vs placebo). UACR remission rates at week 24 were 0.0%, 7.8%, 29.0%, and 28.1% in the placebo and apararenone 2.5 mg, 5 mg, and 10 mg groups, respectively. eGFR tended to decrease and serum potassium tended to increase, but these events were not clinically significant. AE incidence increased with dose while ADR incidence did not.
CONCLUSION


The UACR-lowering effect of apararenone administered once daily for 24 weeks in patients with stage 2 DN was confirmed, and the 52-week administration was safe and tolerable.
CLINICAL TRIAL REGISTRATION


NCT02517320 (dose-response study) and NCT02676401 (extension study).",2020,"As a percentage of baseline, mean UACR decreased to 62.9%, 50.8%, and 46.5% in the 2.5 mg, 5 mg, and 10 mg apararenone groups, respectively, at week 24 (placebo: 113.7% at week 24; all P < 0.001 vs placebo).","['patients with stage 2 diabetic nephropathy (DN', 'patients with diabetic nephropathy']","['apararenone (MT-3995', 'placebo and apararenone', 'Apararenone', 'placebo', 'apararenone']","['UACR remission rates', 'AE incidence', 'glomerular filtration rate (eGFR) and serum potassium', 'mean UACR', 'safe and tolerable', 'serum potassium', 'urine albumin to creatine ratio (UACR) and 24- and 52-week UACR remission rates', 'incidences of adverse events (AEs) and adverse drug reactions (ADRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042038', 'cui_str': 'Albumin urine'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",,0.469329,"As a percentage of baseline, mean UACR decreased to 62.9%, 50.8%, and 46.5% in the 2.5 mg, 5 mg, and 10 mg apararenone groups, respectively, at week 24 (placebo: 113.7% at week 24; all P < 0.001 vs placebo).","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Inagaki', 'Affiliation': 'Data Science Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Yoshinari', 'Affiliation': 'Clinical Research and Development II Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, 103-8405, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Terata', 'Affiliation': 'Clinical Research and Development II Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, 103-8405, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Totsuka', 'Affiliation': 'Clinical Research and Development II Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, 103-8405, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Gotou', 'Affiliation': 'Clinical Research and Development II Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, 103-8405, Japan.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Hashimoto', 'Affiliation': 'Clinical Research and Development II Department, Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, 103-8405, Japan. hashimoto.gaia@ma.mt-pharma.co.jp.'}]",Clinical and experimental nephrology,['10.1007/s10157-020-01963-z']
2986,32974746,Selection of a correct treatment protocol in caesarean scar pregnancies.,"OBJECTIVE


This study aims at assessing the effectiveness of various treatment protocols with the help of some parameters in caesarean scar pregnancies.
METHODS


A total of 26 patients were assessed in the study. The patients were divided into 4 groups. Group 1 consisted of those who had a wedge resection (n = 7), group 2 those who had a suction curettage (n = 10), group 3 those who had a systemic methotrexate (MTX) (n = 5) and group 4 those who had a systemic + local MTX (n = 4). The ßHcg half-lives, haemoglobin levels at the time of admittance and discharge, and hospital stays of the groups were compared.
RESULTS


The difference between group 1 and group 4 was found significant (p = 0.002) with respect to days of hospital stay. There was no statistically significant difference between the groups with respect to ßHcg half-lives and haemoglobin values.
CONCLUSION


The results of our study showed that there were no significant differences between treatment outcomes when appropriate protocols were employed. Therefore, the important point in CSPs is to assess correctly the type of CSP, the myometrial thickness and the patient's hemodynamic condition and select the most appropriate protocol accordingly rather than trying to establish a single standard treatment protocol.",2020,The difference between group 1 and group 4 was found significant (p = 0.002) with respect to days of hospital stay.,"['A total of 26 patients were assessed in the study', 'caesarean scar pregnancies']","['suction curettage', 'wedge resection', 'systemic methotrexate (MTX) (n\u2009=\u20095) and group 4 those who had a systemic\u2009+\u2009local MTX']","['ßHcg half-lives, haemoglobin levels at the time of admittance and discharge, and hospital stays']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0042223', 'cui_str': 'Suction Curettage'}, {'cui': 'C0184909', 'cui_str': 'Wedge resection - action'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",26.0,0.0212301,The difference between group 1 and group 4 was found significant (p = 0.002) with respect to days of hospital stay.,"[{'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Altınboğa', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey. orhanaltinboga@gmail.com.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Yakıştıran', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Seyit Ahmet', 'Initials': 'SA', 'LastName': 'Erol', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Yüksel', 'Initials': 'Y', 'LastName': 'Oğuz', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Batuhan', 'Initials': 'B', 'LastName': 'Bakırarar', 'Affiliation': 'Department of Statistics, Ankara University, Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Cavidan', 'Initials': 'C', 'LastName': 'Gülerman', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Şevki', 'Initials': 'Ş', 'LastName': 'Çelen', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}, {'ForeName': 'Ali Turhan', 'Initials': 'AT', 'LastName': 'Çağlar', 'Affiliation': 'Department of Obstetrics and Gynecology, Ankara City Hospital, Ankara, Turkey.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05800-2']
2987,32978102,Randomized phase II study of a home-based walking intervention for radiation-related fatigue among older adult breast cancer patients.,"BACKGROUND


Fatigue is a common side effect of radiation therapy and can dramatically affect the quality of life in older cancer patients. We compared a home-based graduated walking intervention with a fixed walking recommendation.recommendation to exercise to determine the effects of these interventions during adjuvant radiotherapy (RT) on older women with breast cancer.
METHODS


A randomized phase 2 trial in women ≥65 years, with stage 0-3 breast cancer. Prior to initiating breast RT, women were randomized to a Home-Based Graduated Walking Program (HBGWP) or a fixed walking recommendation. The primary outcome of fatigue was measured by the Total Disruption Index (TDI) of the Fatigue Symptom Inventory (FSI). Secondary outcomes including a short physical performance battery (SPPB) and questionnaires on exercise, physical function, fatigue (PROMIS Fatigue), and fatigue-related symptoms were collected at 3 time points. The primary goal was to compare the change in TDI between arms at the end of RT. Random coefficients models were used to determine the association between arm, fatigue, and exercise over time. Linear regression models were used to describe the change in outcome variables between visits.
RESULTS


Median age of the 54 participants (27 per arm) was 69 years (range 65-84). The baseline characteristics were similar between study arms. The number of minutes walking per week increased in both arms (mean 21 min/wk. baseline to 83 min/wk. end of RT, p < 0.01) and physical function improved over time in both arms (median 10.5 at baseline to 12 at end of RT, p < 0.01).There was no significant difference in change in TDI between arms (2.7 ± 9.9 vs. 1.8 ± 14.0, p = 0.61)between baseline and end of RT. However, in our linear regression model increasing walking over time was associated with statistically significant lower levels of fatigue (-2.44+/- 1.04, p = 0.04), but not in posthoc subgroup analyses.
CONCLUSION


The HBGWP did not decrease fatigue more than the fixed recommendation to exercise. Both the graduated intervention and fixed recommendation lead to increased walking which was associated with lower fatigue in this study of older adult breast cancer patients.",2020,"end of RT, p < 0.01) and physical function improved over time in both arms (median 10.5 at baseline to 12 at end of RT, p < 0.01).There was no significant difference in change in TDI between arms (2.7 ± ","['older cancer patients', 'older women with breast cancer', 'older adult breast cancer patients', 'Median age of the 54 participants (27 per arm) was 69\xa0years (range 65-84', 'women ≥65\xa0years, with stage 0-3 breast cancer']","['adjuvant radiotherapy (RT', 'Home-Based Graduated Walking Program (HBGWP) or a fixed walking recommendation', 'home-based graduated walking intervention with a fixed walking recommendation.recommendation to exercise', 'HBGWP', 'home-based walking intervention']","['levels of fatigue', 'short physical performance battery (SPPB) and questionnaires on exercise, physical function, fatigue (PROMIS Fatigue), and fatigue-related symptoms', 'change in TDI', 'Total Disruption Index (TDI) of the Fatigue Symptom Inventory (FSI', 'number of minutes walking per week', 'fatigue', 'quality of life', 'physical function']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0441763', 'cui_str': 'Stage 0'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1562039', 'cui_str': 'Number of minutes'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0748491,"end of RT, p < 0.01) and physical function improved over time in both arms (median 10.5 at baseline to 12 at end of RT, p < 0.01).There was no significant difference in change in TDI between arms (2.7 ± ","[{'ForeName': 'Noam A', 'Initials': 'NA', 'LastName': 'VanderWalde', 'Affiliation': 'West Cancer Center and Research Institute, 7945 Wolf River Blvd, Germantown, TN 38138, USA; University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA. Electronic address: nvanderw@westclinic.com.'}, {'ForeName': 'Michelle Y', 'Initials': 'MY', 'LastName': 'Martin', 'Affiliation': 'University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kocak', 'Affiliation': 'University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Morningstar', 'Affiliation': 'West Cancer Center and Research Institute, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'University of North Carolina at Chapel Hill/Lineberger Comprehensive Cancer Center, 101 Manning Dr., Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Kirsten A', 'Initials': 'KA', 'LastName': 'Nyrop', 'Affiliation': 'University of North Carolina at Chapel Hill/Lineberger Comprehensive Cancer Center, 101 Manning Dr., Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farmer', 'Affiliation': 'West Cancer Center and Research Institute, 7945 Wolf River Blvd, Germantown, TN 38138, USA; University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Ballo', 'Affiliation': 'West Cancer Center and Research Institute, 7945 Wolf River Blvd, Germantown, TN 38138, USA; University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'VanderWalde', 'Affiliation': 'West Cancer Center and Research Institute, 7945 Wolf River Blvd, Germantown, TN 38138, USA; University of Tennessee Health Science Center, 7945 Wolf River Blvd, Germantown, TN 38138, USA.'}, {'ForeName': 'Hyman', 'Initials': 'H', 'LastName': 'Muss', 'Affiliation': 'University of North Carolina at Chapel Hill/Lineberger Comprehensive Cancer Center, 101 Manning Dr., Chapel Hill, NC 27514, USA.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2020.09.013']
2988,32978116,Betahistine add-on therapy for treatment of subjects with posterior benign paroxysmal positional vertigo: a randomized controlled trial.,"INTRODUCTION


Benign paroxysmal positional vertigo is a common vestibular disorder that accounts for one fifth of hospital admissions due to vertigo, although it is commonly undiagnosed.
OBJECTIVE


To evaluate the effects of betahistine add-on therapy in the treatment of subjects with posterior benign paroxysmal positional vertigo.
METHODS


This randomized controlled study was conducted in a population of 100 subjects with posterior benign paroxysmal positional vertigo. Subjects were divided into the Epley maneuver + betahistine group (group A) and Epley maneuver only (group B) group. Subjects were evaluated before and 1-week after the maneuver using a visual analog scale and dizziness handicap inventory RESULTS: One hundred subjects completed the study protocol. The Epley maneuver had an overall success rate of 95% (96% in group A; 94% in group B, p =  0.024). Groups A and B had similar baseline visual analog scale scores (6.98 ± 2.133 and 6.27 ± 2.148, respectively, p = 0.100). After treatment, the visual analog scale score was significantly lower in both groups, and was significantly lower in group A than group B (0.74 ± 0.853 vs. 1.92 ± 1.288, respectively, p = 0.000). The change in visual analog scale score after treatment compared to baseline was also significantly greater in group A than group B (6.24 ± 2.01 vs. 4.34 ± 2.32, respectively, p = 0.000). The baseline dizziness handicap inventory values were also similar in groups A and B (55.60 ± 22.732 vs. 45.59 ± 17.049, respectively, p = 0.028). After treatment, they were significantly lower in both groups. The change in score after treatment compared to baseline was also significantly greater in group A than group B (52.44 ± 21.42 vs. 35.71 ± 13.51, respectively, p = 0.000).
CONCLUSION


The Epley maneuver is effective for treatment of benign paroxysmal positional vertigo. Betahistine add-on treatment in posterior benign paroxysmal positional vertigo resulted in improvements in both visual analog scale score and dizziness handicap inventory.",2020,"The change in score after treatment compared to baseline was also significantly greater in group A than group B (52.44 ± 21.42 vs. 35.71 ± 13.51, respectively, p = 0.000).
","['100 subjects with posterior benign paroxysmal positional vertigo', 'subjects with posterior benign paroxysmal positional vertigo', 'One hundred subjects completed the study protocol']","['Epley maneuver\u202f+\u202fbetahistine', 'Betahistine', 'betahistine']","['visual analog scale score', 'baseline dizziness handicap inventory values', 'visual analog scale score and dizziness handicap inventory', 'overall success rate', 'baseline visual analog scale scores']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C1279393', 'cui_str': 'Epley maneuver'}, {'cui': 'C0005301', 'cui_str': 'BETAHISTINE'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",100.0,0.136482,"The change in score after treatment compared to baseline was also significantly greater in group A than group B (52.44 ± 21.42 vs. 35.71 ± 13.51, respectively, p = 0.000).
","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Sayin', 'Affiliation': 'Bakırköy Teaching and Research Hospital, Department of Otolaryngology Head and Neck Surgery, Istanbul, Turkey. Electronic address: dribrahimsayin@yahoo.com.'}, {'ForeName': 'Recep Haydar', 'Initials': 'RH', 'LastName': 'Koç', 'Affiliation': 'Bakırköy Teaching and Research Hospital, Department of Otolaryngology Head and Neck Surgery, Istanbul, Turkey.'}, {'ForeName': 'Dastan', 'Initials': 'D', 'LastName': 'Temirbekov', 'Affiliation': 'Istanbul Aydın University, Medical Park Florya Hospital, Department of Otorhinolaryngology, Istanbul, Turkey.'}, {'ForeName': 'Selcuk', 'Initials': 'S', 'LastName': 'Gunes', 'Affiliation': 'Bakırköy Teaching and Research Hospital, Department of Otolaryngology Head and Neck Surgery, Istanbul, Turkey.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Cirak', 'Affiliation': 'Bakırköy Teaching and Research Hospital, Department of Neurosurgery, Istanbul, Turkey.'}, {'ForeName': 'Zahide Mine', 'Initials': 'ZM', 'LastName': 'Yazici', 'Affiliation': 'Bakırköy Teaching and Research Hospital, Department of Otolaryngology Head and Neck Surgery, Istanbul, Turkey. Electronic address: minezahide@yahoo.com.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2020.07.011']
2989,32978121,Does the effect of lifestyle intervention for individuals with diabetes vary by food insecurity status? A preplanned subgroup analysis of the REAL HEALTH randomized clinical trial.,"INTRODUCTION


We aimed to test the effectiveness of a lifestyle intervention (LI) for individuals with food insecurity and type 2 diabetes.
RESEARCH DESIGN AND METHODS


Adults with type 2 diabetes, body mass index ≥25 kg/m 2  (or ≥23 kg/m 2  if Asian), hemoglobin A1c of 6.5%-11.5% (48-97 mmol/mol) and who were willing to lose 5%-7% bodyweight were enrolled in REAL HEALTH-Diabetes. This practice-based randomized clinical trial compared LI (delivered inperson or by telephone) with medical nutrition therapy (MNT) on weight loss at 6 and 12 months. Two or more affirmative responses on the six-item US Department of Agriculture Food Security Survey Module indicated food insecurity. In this prespecified subgroup analysis, we tested using linear mixed effects models whether the intervention effect varied by food security status.
RESULTS


Of 208 participants, 13% were food insecure. Those with food insecurity were more likely to be racial/ethnic minorities (p<0.001) and have lower education (p<0.001). LI, versus MNT, led to greater weight loss at 6 months (5.1% lost vs 1.1% lost; p<0.0001) and 12 months (4.7% lost vs 2.0% lost; p=0.0005). The intervention effect was similar regardless of food security status (5.1% bodyweight lost vs 1.1% in food secure participants and 5.1% bodyweight lost vs 1.3% in food insecure participants at 6 months; 4.7% bodyweight lost vs 2.1% in food secure participants and 4.5% bodyweight lost vs 0.9% in food insecure participants at 12 months; p for interaction=0.99).
CONCLUSIONS


The REAL HEALTH-Diabetes lifestyle intervention led to meaningful weight loss for individuals with food insecurity and type 2 diabetes.
TRIAL REGISTRATION NUMBER


NCT02320253.",2020,Those with food insecurity were more likely to be racial/ethnic minorities (p<0.001) and have lower education (p<0.001).,"['individuals with diabetes vary by food insecurity status', 'Adults with type', '208 participants', 'individuals with food insecurity and type 2 diabetes']","['lifestyle intervention', 'LI (delivered inperson or by telephone) with medical nutrition therapy (MNT', 'lifestyle intervention (LI']","['weight loss', 'food security status']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",208.0,0.185464,Those with food insecurity were more likely to be racial/ethnic minorities (p<0.001) and have lower education (p<0.001).,"[{'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Berkowitz', 'Affiliation': 'Division of General Medicine & Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Porneala', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Cromer', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA Delahanty.linda@mgh.harvard.edu DWEXLER@mgh.harvard.edu.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA Delahanty.linda@mgh.harvard.edu DWEXLER@mgh.harvard.edu.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001514']
2990,32978182,Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial.,"INTRODUCTION


Neuroplasticity is defined as the capacity of the brain to reorganise new neuronal pathways. Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke. Home-based interventions are an appropriate alternative to promote independence and autonomy. The objective of this study is to evaluate which of these techniques, MT and CTE, combined with task-oriented training, is more effective in functional recovery and movement patterns of the upper extremities in patients with severe hemiparesis after a stroke.
METHODS AND ANALYSIS


This is a home-based, single-blind, controlled, randomised clinical trial with three parallel arms, including 154 patients who had a stroke aged above 18 years. The primary outcome will be the functionality of the affected upper extremity measured using the Fugl-Meyer Assessment. Secondary variables will include cognitive performance, emotional state, quality of life and activities of daily living. During 6 weeks, one of the intervention groups will receive a treatment based on MT and the other one on CTE, both combined with task-oriented training. No additional interventions will be provided to the control group. To assess the progress of patients who had a stroke in the subacute phase, all variables will be evaluated at different visits: initial (just before starting treatment and 4 weeks post-stroke), post-intervention (6 weeks after initial) and follow-up (6 months).
ETHICS AND DISSEMINATION


This protocol has been approved by the Institutional Review Board (CEIm-2.134/2.019) and registered at ClinicalTrials.gov (NCT04163666). The results will be disseminated through open-access peer-reviewed journals, conference presentation, broadcast media and a presentation to stakeholders. These study results will provide relevant and novel information on effective neurorehabilitation strategies and improve the quality of intervention programmes aimed at patients after a stroke.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (NCT04163666).",2020,Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke.,"['154 patients who had a stroke aged above 18 years', 'patients with severe hemiparesis after a stroke']","['home-based mirror therapy and cognitive therapeutic exercise', 'Mirror therapy (MT) and cognitive therapeutic exercise (CTE', 'MT and the other one on CTE, both combined with task-oriented training', 'MT and CTE, combined with task-oriented training']","['cognitive performance, emotional state, quality of life and activities of daily living', 'functionality of the affected upper extremity measured using the Fugl-Meyer Assessment']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",154.0,0.129301,Mirror therapy (MT) and cognitive therapeutic exercise (CTE) are two neurorehabilitation techniques based on neuroplasticity and designed to improve the motor functions of the affected upper extremity in patients with severe hemiparesis after a stroke.,"[{'ForeName': 'Josefa', 'Initials': 'J', 'LastName': 'Gonzalez-Santos', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Soto-Camara', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain rscamara@ubu.es.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rodriguez-Fernández', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Jimenez-Barrios', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Jeronimo', 'Initials': 'J', 'LastName': 'Gonzalez-Bernal', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Collazo-Riobo', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Jahouh', 'Affiliation': 'Health Sciences, University of Burgos, Burgos, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Bravo-Anguiano', 'Affiliation': 'Neurology, Burgos University Hospital, Burgos, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Trejo-Gabriel-Galan', 'Affiliation': 'Neurology, Burgos University Hospital, Burgos, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-035768']
2991,32978194,Rehabilitation nursing for motor functional recovery of acute ischaemic stroke: study protocol for a randomised controlled trial.,"INTRODUCTION


Stroke is the second-leading cause of death and disability in the world, and patients with stroke often suffer from functional impairments and need rehabilitation. Notably, there is much evidence that rehabilitation can lead to better mortality and morbidity outcomes. The evidence for the effectiveness of rehabilitation nursing, however, is limited. Thus, this study seeks to explore whether rehabilitation nursing is not inferior to usual rehabilitation for motor functional recovery in patients with acute ischaemic stroke.
METHODS AND ANALYSIS


We will conduct an assessor-blinded parallel randomised controlled trial of patients who meet the inclusion criteria after stratification by weighted corticospinal tract lesion load. The experimental group will receive rehabilitation nursing by trained and qualified nurses (seven consecutive days, two sessions per day, 30 min each session). The control group will receive usual rehabilitation provided by therapists (seven consecutive days, two sessions per day, 30 min each session). The primary outcome measures are the Motor Assessment Scale, the Fugl-Meyer Assessment and the Action Research Arm Test. The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale. Primary and secondary outcome assessment will be performed before and after the intervention, and secondary outcome be assessed at 4 and 12 weeks follow-up. We will recruit 224 patients within a period of 12-18 months from a hospital in southeastern China.
ETHICS AND DISSEMINATION


The study was approved by the Human Research Ethics Committee from the corresponding author's hospital (approval Number is Ethical Review Study No. 2018 - 112). Peer-reviewed journals and presentations at national and international conferences will be used to disseminate the results.
TRIAL REGISTRATION NUMBER


NCT03702452.",2020,"The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale.","['patients with stroke often suffer from functional impairments and need rehabilitation', 'patients with acute ischaemic stroke', 'patients who meet the inclusion criteria after stratification by weighted corticospinal tract lesion load', '224 patients within a period of 12-18\u2009months from a hospital in southeastern China', 'acute ischaemic stroke']","['usual rehabilitation provided by therapists', 'Rehabilitation nursing', 'rehabilitation nursing by trained and qualified nurses']","['Motor Assessment Scale, the Fugl-Meyer Assessment and the Action Research Arm Test', 'modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0936236', 'cui_str': 'Corticospinal Tracts'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0376427', 'cui_str': 'Nursing, Rehabilitation'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0451321', 'cui_str': 'Motor assessment scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",224.0,0.142712,"The secondary outcome measures are the modified Rankin Scale, the modified Barthel Index and the National Institute of Health Stroke Scale.","[{'ForeName': 'Jianmiao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Neurology Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Jingfen', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Nursing Department, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China zrjzkhl@zju.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2020-037391']
2992,32978200,"Protocol, rationale and design of DAbigatran for Stroke PreVention In Atrial Fibrillation in MoDerate or Severe Mitral Stenosis (DAVID-MS): a randomised, open-label study.","INTRODUCTION


Current international guidelines recommend non-vitamin K oral anticoagulants (NOACs) for stroke prevention among patients with non-valvular atrial fibrillation (AF) at significant ischaemic stroke risk given the superior safety and comparable efficacy of NOACs over warfarin. Nonetheless, the safety and effectiveness of NOACs have not been evaluated in patients with AF with underlying moderate or severe mitral stenosis (MS), hence the recommended stroke prevention strategy remains warfarin therapy.
METHOD AND ANALYSIS


MS remains disproportionately prevalent in Asian countries compared with the developed countries. This prospective, randomised, open-label trial with blinded endpoint adjudication aims to evaluate the safety and efficacy of dabigatran for stroke prevention in AF patients with moderate or severe MS. Patients with AF aged ≥18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months will be randomised in a 1:1 ratio to receive dabigatran 110 mg or 150 mg two times per day or warfarin with international normalised ratio 2-3 in an open-label design. Patients with estimated creatinine clearance <30 mL/min, or with a concomitant indication for antiplatelet therapy will be excluded. The primary outcome is a composite of stroke and systemic embolism. Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death. The estimated required sample size is approximately 686 participants.
ETHICS AND DISSEMINATION


The study protocol has been approved by the Institutional Review Board of the University of Hong Kong and Hong Kong West Cluster, Hospital Authority, Hong Kong for Fung Yiu King Hospital, Grantham Hospital, Queen Mary Hospital and Tung Wah Hospital in Hong Kong. Results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04045093); pre-results.",2020,"Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death.","['686 participants', 'patients with AF with underlying moderate or severe mitral stenosis (MS', 'patients with non-valvular atrial fibrillation (AF', 'AF patients with moderate or severe MS', 'Patients with estimated creatinine clearance <30\u2009mL/min, or with a concomitant indication for antiplatelet therapy will be excluded', 'MoDerate or Severe Mitral Stenosis (DAVID-MS', 'Patients with AF aged ≥18 years with moderate or severe MS not planned for valvular intervention in the coming 12 months']","['vitamin K oral anticoagulants (NOACs', 'DAbigatran', 'dabigatran 110\u2009mg or 150\u2009mg two times per day or warfarin with international normalised ratio 2-3 in an open-label design', 'dabigatran']","['ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death', 'safety and efficacy', 'composite of stroke and systemic embolism']","[{'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026269', 'cui_str': 'Mitral valve stenosis'}, {'cui': 'C1273051', 'cui_str': 'Estimated creatinine clearance'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.205221,"Secondary outcomes are ischaemic stroke, systemic embolism, haemorrhagic stroke, intracranial haemorrhage, major bleeding and death.","[{'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Esther W', 'Initials': 'EW', 'LastName': 'Chan', 'Affiliation': 'Department of Pharmacology and Pharmacy, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Jo Jo', 'Initials': 'JJ', 'LastName': 'Hai', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chun Ka', 'Initials': 'CK', 'LastName': 'Wong', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Yuk Ming', 'Initials': 'YM', 'LastName': 'Lau', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Cheung Chi', 'Initials': 'CC', 'LastName': 'Lam', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chor Cheung Frankie', 'Initials': 'CCF', 'LastName': 'Tam', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Yiu Tung Anthony', 'Initials': 'YTA', 'LastName': 'Wong', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'See Yue Arthur', 'Initials': 'SYA', 'LastName': 'Yung', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Ki Wan Kelvin', 'Initials': 'KWK', 'LastName': 'Chan', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Yingqing', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Cardiology Division, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tan', 'Affiliation': 'Cardiology Division, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ji-Yan', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Cardiology Division, Guangdong Cardiovascular Institute, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chi Yui', 'Initials': 'CY', 'LastName': 'Yung', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Ruttonjee and Tang Siu Kin Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Kwok Lun', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Ruttonjee and Tang Siu Kin Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chun Wai', 'Initials': 'CW', 'LastName': 'Choi', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Tuen Mun Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Ho', 'Initials': 'H', 'LastName': 'Lam', 'Affiliation': 'Cardiology Division, Department of Medicine and Geriatrics, Tuen Mun Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Cardiac Medical Unit, Grantham Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Fan', 'Affiliation': 'Cardiac Medical Unit, Grantham Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Man Hong', 'Initials': 'MH', 'LastName': 'Jim', 'Affiliation': 'Cardiac Medical Unit, Grantham Hospital, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Kai Hang', 'Initials': 'KH', 'LastName': 'Yiu', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Yan', 'Affiliation': 'Cardiology Division, Department of Medicine & Therapeutics, Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Chung Wah', 'Initials': 'CW', 'LastName': 'Siu', 'Affiliation': 'Cardiology Division, Department of Medicine, University of Hong Kong, Hong Kong, Hong Kong SAR, China cwdsiu@hku.hk.'}]",BMJ open,['10.1136/bmjopen-2020-038194']
2993,32978204,Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial.,"INTRODUCTION


Studies have indicated that hip and knee muscle strengthening are effective in reducing pain, improving self-reported function and increasing lower limb strength, without, however, decreasing knee joint overload during gait in patients with knee osteoarthritis (KOA). Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain. The aim of this paper is to investigate whether an 8-week therapeutic foot-ankle exercise programme improves pain, functionality, foot strength, foot kinematics and knee joint overload during gait, and decreases medication intake in individuals with KOA.
METHODS AND ANALYSIS


This two-arm, prospectively registered, randomised controlled trial with blinded assessors will involve 88 patients with medial tibiofemoral osteoarthritis. Subjects will be randomly allocated to a control group that will receive no specific foot intervention and will follow treatment recommended by the medical team; or an intervention group that will undergo an 8-week physiotherapist-supervised strengthening programme for extrinsic and intrinsic foot muscles, three times a week. The primary outcome will be the pain domain of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). The secondary outcomes include WOMAC stiffness and function domains, total WOMAC score, physical function, foot muscle isometric strength, foot kinematics and knee kinetics during gait, and medication intake. Data will be analysed on intention-to-treat principles and a per protocol basis.
ETHICS AND DISSEMINATION


Investigators and sponsors will communicate trial results to participants and healthcare professionals through scientific databases and social media. In addition, findings will be reported in peer-review publications, and at national and international conference presentations. Ethics approval: Ethics Committee of the Universidade Federal de São Carlos, São Carlos, SP, Brazil (N° 3.488.466).
TRIAL REGISTRATION NUMBER


NCT04154059.",2020,Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain.,"['individuals with KOA', 'patients with knee osteoarthritis (KOA', 'diabetic patients', 'people with knee osteoarthritis', '88 patients with medial tibiofemoral osteoarthritis']","['therapeutic foot-ankle exercise programme', 'control group that will receive no specific foot intervention and will follow treatment recommended by the medical team; or an intervention group that will undergo an 8-week physiotherapist-supervised strengthening programme', 'foot-ankle strengthening programme']","['clinical aspects and gait biomechanics', 'patellofemoral pain', 'pain domain of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC', 'WOMAC stiffness and function domains, total WOMAC score, physical function, foot muscle isometric strength, foot kinematics and knee kinetics during gait, and medication intake', 'pain, functionality, foot strength, foot kinematics and knee joint overload during gait']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0454369', 'cui_str': 'Ankle exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0581753', 'cui_str': 'Muscle structure of foot'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}]",88.0,0.0910656,Recent research has shown that strengthening the foot-ankle muscles improved function in diabetic patients and reduced patellofemoral pain.,"[{'ForeName': 'Glauko', 'Initials': 'G', 'LastName': 'Dantas', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Isabel C N', 'Initials': 'ICN', 'LastName': 'Sacco', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, USP, Sao Paulo, Brazil.'}, {'ForeName': 'Ana F', 'Initials': 'AF', 'LastName': 'Dos Santos', 'Affiliation': 'UNA University Center, Pouso Alegre, Brazil.'}, {'ForeName': 'Ricky', 'Initials': 'R', 'LastName': 'Watari', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, USP, Sao Paulo, Brazil.'}, {'ForeName': 'Alessandra B', 'Initials': 'AB', 'LastName': 'Matias', 'Affiliation': 'Department of Physical Therapy, Speech, and Occupational Therapy, USP, Sao Paulo, Brazil.'}, {'ForeName': 'Paula R M S', 'Initials': 'PRMS', 'LastName': 'Serrao', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'Pott-Junior', 'Affiliation': 'Department of Medicine, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Tania F', 'Initials': 'TF', 'LastName': 'Salvini', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos (UFSCar), São Carlos, São Paulo, Brazil tania@ufscar.br.'}]",BMJ open,['10.1136/bmjopen-2020-039279']
2994,32978218,Multiprofessional intervention to improve adherence to medication in stroke patients: a study protocol for a randomised controlled trial (ADMED AVC study).,"INTRODUCTION


Adherence to secondary preventive medications is often suboptimal in patients with stroke, exposing them to an increased risk of recurrent cerebral and/or cardiovascular events. Effective actions in the long term to improve adherence to medication are needed. The study will evaluate the efficacy of a collaborative multiprofessional patient-centred intervention conducted by a pharmacist on adherence to secondary preventive medication in stroke survivors.
METHODS AND ANALYSIS


This is a multicentre cluster-randomised controlled trial. Two groups of 91 patients (intervention vs standard care) will be recruited. The clinical pharmacist intervention targeting secondary preventive medication will consist of three parts over 1 year: (1) an individual semi-structured interview at hospital discharge; (2) follow-up telephone interviews at 3, 6 and 9 months after discharge; and (3) a final individual semi-structured interview 1 year after discharge. Information on patient follow-up will be shared with the general practitioner and the community pharmacist by sending a report of each interview. The primary outcome is adherence to medication during the 12 months after hospital discharge, assessed using a composite endpoint: the medication possession ratio associated with a self-administered questionnaire.
ETHICS AND DISSEMINATION


The local ethics committee, the national committee for use of personal data in medical research and the national data protection agency approved the study. The sponsor has no role in study design; collection, analysis and interpretation of data; or report writing.
DISCUSSION


This pharmacist-led educational programme has the potential to significantly improve adherence to medication in stroke survivors which could lead to a decrease in recurrent cerebral and/or cardiovascular events.
TRIAL REGISTRATION NUMBER


NCT02611440.",2020,"This pharmacist-led educational programme has the potential to significantly improve adherence to medication in stroke survivors which could lead to a decrease in recurrent cerebral and/or cardiovascular events.
","['stroke survivors', 'stroke patients', 'patients with stroke']","['collaborative multiprofessional patient-centred intervention', 'Multiprofessional intervention']","['adherence to medication during the 12 months after hospital discharge, assessed using a composite endpoint: the medication possession ratio associated with a self-administered questionnaire']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.111833,"This pharmacist-led educational programme has the potential to significantly improve adherence to medication in stroke survivors which could lead to a decrease in recurrent cerebral and/or cardiovascular events.
","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Khettar', 'Affiliation': 'Department of Pharmacy, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France sophie.khettar@chu-lyon.fr.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jacquin Courtois', 'Affiliation': 'Physical medicine and rehabilitation department, Henry Gabrielle Hospital, Hospices Civils de Lyon, Saint-Genis-Laval, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Luaute', 'Affiliation': 'Physical medicine and rehabilitation department, Henry Gabrielle Hospital, Hospices Civils de Lyon, Saint-Genis-Laval, France.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Decullier', 'Affiliation': 'Public Health Center, Research and Clinical Epidemiology, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bin', 'Affiliation': 'Public Health Center, Research and Clinical Epidemiology, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Dupuis', 'Affiliation': 'Public Health Center, Research and Clinical Epidemiology, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Derex', 'Affiliation': 'EA 7425 HESPER Health Services and Performance Research, Claude Bernard University Lyon1, Lyon, France.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mechtouff', 'Affiliation': 'Stroke center, Pierre Wertheimer Hospital, Hospices Civils de Lyon, Bron, France.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Nighoghossian', 'Affiliation': 'Stroke center, Pierre Wertheimer Hospital, Hospices Civils de Lyon, Bron, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Dussart', 'Affiliation': 'EA 4129 P2S Parcours Santé Systémique, Claude Bernard University Lyon 1, Lyon, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Rode', 'Affiliation': 'Physical medicine and rehabilitation department, Henry Gabrielle Hospital, Hospices Civils de Lyon, Saint-Genis-Laval, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Janoly-Dumenil', 'Affiliation': 'Department of Pharmacy, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France.'}]",European journal of hospital pharmacy : science and practice,['10.1136/ejhpharm-2020-002425']
2995,32978540,What are the effects of verbal and written information on pain perception in orthodontic patients?,"Design Randomised controlled trial.Study population Sixty patients aged 10-18 years requiring fixed orthodontic treatment were randomly allocated to the study or control group. Anxiety levels and somatosensory amplification were evaluated. All patients received general verbal instructions on orthodontic treatment (dietary habits, oral hygiene maintenance and pain). Patients in the study group also received written information (a take-home leaflet) on orthodontic pain characteristics and management. Patients, clinicians and statistician were blinded to the patient allocation.Outcome measure The primary outcome was the pain intensity and the secondary outcome was analgesic consumption.Data analysis Multilevel regression analysis of variance (ANOVA) for repeated measures with split plot design.Results Pain perception and analgesic consumption were significantly higher in the control group only during the first two days after appliance placement (P <0.05).Conclusions Combining verbal and written information diminished pain perception and analgesic consumption in orthodontic patients in the first days after appliance placement.",2020,Results Pain perception and analgesic consumption were significantly higher in the control group only during the first two days after appliance placement (P <0.05).Conclusions,"['Study population Sixty patients aged 10-18 years requiring fixed orthodontic treatment', 'orthodontic patients', 'orthodontic patients in the first days after appliance placement']","['general verbal instructions', 'written information (a take-home leaflet']","['Pain perception and analgesic consumption', 'analgesic consumption', 'pain intensity', 'Anxiety levels and somatosensory amplification', 'pain perception and analgesic consumption', 'pain perception']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",60.0,0.189931,Results Pain perception and analgesic consumption were significantly higher in the control group only during the first two days after appliance placement (P <0.05).Conclusions,"[{'ForeName': 'Paulo Antônio', 'Initials': 'PA', 'LastName': 'Martins-Júnior', 'Affiliation': 'Department of Child and Adolescent Oral Health, Faculty of Dentistry, Federal University of Minas Gerais, Brazil.'}]",Evidence-based dentistry,['10.1038/s41432-020-0124-4']
2996,32978541,What should we be doing for children in our general practices?,"This paper reports the findings from a research project named FiCTION (Filling Children's Teeth: Indicated or Not?).Design FiCTION was a multi-centre, parallel-group, patient-randomised controlled trial comparing the effectiveness of three treatment strategies. There were three strategies within the trial: conventional caries removal and restoration plus prevention (C+P); biological sealing-in caries plus prevention (B+P); and prevention alone (PA).Case selection Children aged 3-7 years with at least one asymptomatic primary molar carious into dentine were included in the study. Participants were randomly allocated to one of the three treatment strategies. Dental professional's (DPs) attended one day training for treatment delivery. Seventy two practices randomised at least one participant. Ten practices withdrew but data collected to the withdrawal date were included in the analysis. The project ran for 3 years between 2012 and 2015. One thousand and fifty eight participants (C+P:352; B+P:352; PA:354) from 68 practices were included in the analysis set. Baseline demographic and clinical characteristics for each arm of the study were balanced.During routine practice visits data were collected on a case report form (CRF). The data included:A. Co-primary outcomes: pain due to caries and evidence of dental infection (without radiographic evidence)B. Secondary outcomes: cost effectiveness, oral health related quality of life (COHRQOL), parental and caregivers perception questionnaire (P-CPQ-16), modified child dental anxiety scale, child and parent-reported anticipatory and treatment-related anxiety, caries incidence at baseline and final visit, qualitative views of parents/carers and DPs.Sound methodology was described in the narrative of the paper. The median follow-up period was 33.8 months (IQR 23.8, 36.7).Results For the co-primary outcomes the proportions of participants with at least one episode of dental pain and/or infection were: C+P 42%, B+P 40%, PA 45%. When comparing C+P with B+P and PA, there were no significant observed differences, adjusted risk difference (97.5%CI): B+P vs C+P -2%(-10%, 6%), PA vs C+P 4% (-4%, 12%). The number of episodes of dental pain and/or infection were C+P 0.62 (sd 0.95), B+P 0.58 (sd 0.87), PA 0.72 (sd 0.98). When comparing C+P with B+P and PA no significant differences were observed, adjusted incident rate ratio (97.5% CI): B+P vs C+P 0.95 (0.75, 1.21), PA vs C+P 1.18 (0.94, 1.48).Secondary outcomes:• Cost effectiveness, PA was the least costly but least effective for both co-primary outcomes with little evidence in this paper as to how and why B+P and C+P would provide greater benefits• COHRQOL, P-CPQ-16, anxiety showed no statistical differences• Parent reported anticipatory anxiety showed differences between PA vs C+P; 6% lower in the PA arm, adjusted risk difference -0.06 ((97.5% CI): -0.11 to -0.003)• Caries incidence showed no differences in the caries in primary or first permanent molars• Qualitative views showed that all three approaches were generally acceptable but trust in the dental professional played a significant role. Local anaesthesia and dental extractions were generally viewed more negatively.Conclusions There were no statistical differences between the three strategies for the co-primary outcomes, namely the incidence or number of episodes of dental pain and/or infection experienced by the study participants. The secondary outcomes suggest less anticipatory anxiety in the PA arm of the trial and that local anaesthesia and dental extractions were viewed negatively.",2020,"There were no statistical differences between the three strategies for the co-primary outcomes, namely the incidence or number of episodes of dental pain and/or infection experienced by the study participants.","['PA).Case selection Children aged 3-7 years with at least one asymptomatic primary molar carious into dentine were included in the study', 'One thousand and fifty eight participants (C+P:352; B+P:352; PA:354) from 68 practices were included in the analysis set']",['conventional caries removal and restoration plus prevention (C+P); biological sealing-in caries plus prevention (B+P); and prevention alone'],"['pain due to caries and evidence of dental infection (without radiographic evidence)B', 'adjusted risk difference (97.5%CI', 'dental pain and/or infection', 'number of episodes of dental pain and/or infection', 'cost effectiveness, oral health related quality of life (COHRQOL), parental and caregivers perception questionnaire (P-CPQ-16), modified child dental anxiety scale, child and parent-reported anticipatory and treatment-related anxiety, caries incidence at baseline and final visit, qualitative views of parents/carers and DPs', 'anticipatory anxiety', 'incidence or number of episodes of dental pain and/or infection', 'adjusted incident rate ratio', 'local anaesthesia and dental extractions']","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0877046', 'cui_str': 'Infection of tooth'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0231397', 'cui_str': 'Anticipatory anxiety'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]",,0.174766,"There were no statistical differences between the three strategies for the co-primary outcomes, namely the incidence or number of episodes of dental pain and/or infection experienced by the study participants.","[{'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Richards', 'Affiliation': 'Visiting Professor Community General Dental Practice, Faculty of Life Sciences and Education, University of South Wales, Glyntaff, Pontypridd, Wales, CF37 4BD, UK.'}]",Evidence-based dentistry,['10.1038/s41432-020-0121-7']
2997,32978546,Does motivational interviewing contribute to caries prevention in children from lower income families?,"Aim To investigate the differential preventive effect of motivational interviewing on early childhood caries according to socioeconomic variables in a primary healthcare setting. Trial design Randomised, double-blind trial with two parallel groups, based in a community setting.Study population Selected from an invited subgroup of children born in 2013 and 2014 in the northern area of the city of Porto Alegre, Rio Grande do Sul, BrazilInterventions Primary caregivers of the patients were randomised to receive information about breastfeeding, child nutrition and oral hygiene during an initial dental appointment in the patient's first year of life either by conventional delivery techniques or by motivational interviewing.Outcomes Analysis of dmfs index from clinical examinationResults Nine-hundred and fifteen patients were randomised to the two arms and 414 children were included in the study, with 501 lost to follow up. One-hundred and eighty-six received conventional health education, and 228 received motivational interviewing. The caries rate per 100 surface year was 1.29 for the conventional education group, and 0.46 for the motivational interviewing group. The effect of motivational interviewing was statistically significant in the lower-income category with prevention of 57% of carious lesions. There was no such statistically significant difference in the higher income subjects.Conclusions The outcome showed reduced caries experience by children where their primary caregiver has received preventative advice via a motivational interviewing technique when compared to conventional education methods. This study suggests that motivational interviewing is more effective in more disadvantaged groups.",2020,"The caries rate per 100 surface year was 1.29 for the conventional education group, and 0.46 for the motivational interviewing group.","['clinical examinationResults Nine-hundred and fifteen patients were randomised to the two arms and 414 children were included in the study, with 501 lost to follow up', 'early childhood caries according to socioeconomic variables in a primary healthcare setting', 'One-hundred and eighty-six received', 'children from lower income families', 'Study population Selected from an invited subgroup of children born in 2013 and 2014 in the northern area of the city of Porto Alegre']","['conventional health education, and 228 received motivational interviewing', 'conventional delivery techniques or by motivational interviewing', 'preventative advice via a motivational interviewing technique', 'motivational interviewing']",['caries rate'],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}]",915.0,0.103488,"The caries rate per 100 surface year was 1.29 for the conventional education group, and 0.46 for the motivational interviewing group.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'McCann', 'Affiliation': 'Post-CCST StR in Paediatric Dentistry, Department of Paediatric Dentistry, Glasgow Dental Hospital and School, 378 Sauchiehall Street, Glasgow, UK.'}]",Evidence-based dentistry,['10.1038/s41432-020-0127-1']
2998,32978652,Intramedullary nailing via suprapatellar approach versus locked plating of proximal extra-articular tibial fractures: a randomized control trial.,"OBJECTIVE


Currently, nailing through the suprapatellar approach and minimally invasive plating have been generally accepted in the management of displaced proximal tibial fractures. This investigation was aimed at comparing these two treatment methods in terms of their effectiveness and safety.
METHODS


We randomized 328 patients into one of two groups: one underwent intramedullary nailing via the suprapatellar approach (IMN group), while the other underwent locking compressive plate (LCP group) placement. The primary outcome was the Iowa Knee Score at 12 months. The clinical history, amount of intra-operative blood loss, rate of fracture healing, and post-operative complications were assessed as secondary outcomes. Participants were assessed at one, two, three, six and 12 months after surgery.
RESULTS


Follow-up data for a year were available for 152 and 154 patients in the IMN group and LCP group, respectively. No intergroup difference was detected with regard to the Iowa Knee Scores (91 ± 8.2 in the IMN group and 90 ± 7.3 in the LCP group, respectively (p = 0.26)), at 12 months. Duration of operation (83.5 ± 35.3 min), amount of blood loss (55 ± 43 mL), duration of fluoroscopy (53.7 ± 3.9 s), and cases with difficult reduction (n = 46) in the IMN group did not differ significantly from those in the LCP group (80.1 ± 43.6 min; 65 ± 56 mL; 48 ± 12 s; 32) (p < 0.05). The two groups had similar post-operative complications and rate of fracture union, with the pre-injury activity level being restored in most patients. Removal of the implants was performed in 31.6% and 63.0% of the cases in the IMN and LCP groups, respectively, indicating a significant intergroup difference.
CONCLUSION


Both IMN through the suprapatellar approach and minimally invasive LCP were found to yield no significant intergroup difference of clinical outcomes in the treatment of proximal, extra-articular tibial fractures. However, the requirement of implant removal was more relevant to LCP.",2020,"Both IMN through the suprapatellar approach and minimally invasive LCP were found to yield no significant intergroup difference of clinical outcomes in the treatment of proximal, extra-articular tibial fractures.","['proximal extra-articular tibial fractures', '328 patients into one of two groups: one underwent']","['intramedullary nailing via the suprapatellar approach (IMN group), while the other underwent locking compressive plate (LCP group) placement', 'LCP', 'Intramedullary nailing via suprapatellar approach versus locked plating']","['Iowa Knee Score', 'similar post-operative complications and rate of fracture union, with the pre-injury activity level', 'Iowa Knee Scores', 'amount of blood loss (55 ± 43 mL), duration of fluoroscopy', 'intra-operative blood loss, rate of fracture healing, and post-operative complications']","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0022132', 'cui_str': 'Isle of Man'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}]","[{'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}]",328.0,0.0780565,"Both IMN through the suprapatellar approach and minimally invasive LCP were found to yield no significant intergroup difference of clinical outcomes in the treatment of proximal, extra-articular tibial fractures.","[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Orthopedic Trauma, the First Hospital of Jilin University, No. 71 Xinmin Street, Changchun, Jilin, 130021, China.'}, {'ForeName': 'Yan-Hui', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology and Echocardiography, the First Hospital of Jilin University, Changchun, 130021, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'Department of Obstetrics and Gynecology, Second Hospital of Jilin University, Changchun, 136461, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedic Trauma, the First Hospital of Jilin University, No. 71 Xinmin Street, Changchun, Jilin, 130021, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthopedic Trauma, the First Hospital of Jilin University, No. 71 Xinmin Street, Changchun, Jilin, 130021, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopedic Trauma, the First Hospital of Jilin University, No. 71 Xinmin Street, Changchun, Jilin, 130021, China. tanlei1982@foxmail.com.'}]",International orthopaedics,['10.1007/s00264-020-04821-5']
2999,32978751,"The additive effects of exercise and essential amino acid on muscle mass and strength in community-dwelling older Japanese women with muscle mass decline, but not weakness and slowness: a randomized controlled and placebo trial.","BACKGROUND


Exercise and essential amino acid supplementation have been separately shown to improve muscle mass in elderly people, however, the combined, added effects of both interventions have yielded inconsistent results on muscle mass, strength, and physical function improvement.
AIMS


To investigate the additive effects of exercise and essential amino acid supplementation on muscle mass, strength, and walking ability in older Japanese women with muscle mass decline, but not weakness and slowness.
METHODS


One hundred thirty women over 65 years of age were defined as having muscle decline and randomly assigned into two groups; exercise and amino acid supplementation (n = 65) or exercise and placebo supplementation (n = 65). The exercise group attended a 60-min comprehensive training program once a week and were encouraged to perform a home-based exercise program. The amino acid or placebo group ingested a 3 g supplement daily for 3-month. Body composition was determined by bioelectrical impedance analysis. Interview data and functional fitness measurements, such as muscle strength and walking ability were collected at baseline and after the 3-month intervention.
RESULTS


There were no significant group × time interactions in primary outcomes such as muscle mass and strength. However, interactions were observed in the degree of low back discomfort (P = 0.014). Percent change of low back discomfort was significantly greater in exercise + amino acid group compared with exercise + placebo group.
CONCLUSIONS


The combination of exercise and amino acid supplementation had a beneficial effect on low back discomfort. However, additional effects were not observed in primary outcomes including muscle mass and strength in this population.",2020,"Percent change of low back discomfort was significantly greater in exercise + amino acid group compared with exercise + placebo group.
","['elderly people', 'older Japanese women with muscle mass decline, but not weakness and slowness', 'One hundred thirty women over 65\xa0years of age were defined as having muscle decline', 'community-dwelling older Japanese women with muscle mass decline, but not weakness and slowness']","['exercise and amino acid supplementation (n\u2009=\u200965) or exercise and placebo supplementation', 'Exercise and essential amino acid supplementation', 'exercise and essential amino acid', 'exercise\u2009+\u2009placebo', 'exercise and amino acid supplementation', 'exercise and essential amino acid supplementation', 'placebo', 'amino acid or placebo', 'exercise group attended a 60-min comprehensive training program once a week and were encouraged to perform a home-based exercise program']","['muscle mass and strength', 'degree of low back discomfort', 'muscle mass, strength, and walking ability', 'Body composition', 'Interview data and functional fitness measurements, such as muscle strength and walking ability', 'low back discomfort']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0235706', 'cui_str': 'Back distress'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",130.0,0.305477,"Percent change of low back discomfort was significantly greater in exercise + amino acid group compared with exercise + placebo group.
","[{'ForeName': 'Hunkyung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, 35-2 Sakaecho, Itabashi-ku, Tokyo, 173-0015, Japan. kimhk@tmig.or.jp.'}, {'ForeName': 'Narumi', 'Initials': 'N', 'LastName': 'Kojima', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, 35-2 Sakaecho, Itabashi-ku, Tokyo, 173-0015, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Uchida', 'Affiliation': 'Ajinomoto Co, Inc., Kawasaki, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Somekawa', 'Affiliation': 'Ajinomoto Co, Inc., Kawasaki, Japan.'}, {'ForeName': 'Naohiko', 'Initials': 'N', 'LastName': 'Inoue', 'Affiliation': 'Ajinomoto Co, Inc., Kawasaki, Japan.'}, {'ForeName': 'Hisamine', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Ajinomoto Co, Inc., Kawasaki, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Osuka', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, 35-2 Sakaecho, Itabashi-ku, Tokyo, 173-0015, Japan.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01713-x']
3000,32978755,The AWAKE-HF Study: Sacubitril/Valsartan Impact on Daily Physical Activity and Sleep in Heart Failure.,"BACKGROUND


AWAKE-HF evaluated the effect of the initiation of sacubitril/valsartan versus enalapril on activity and sleep using actigraphy in patients who have heart failure with reduced ejection fraction (HFrEF).
METHODS


In this randomized, double-blind study, patients with HFrEF (n = 140) were randomly assigned to sacubitril/valsartan or enalapril for 8 weeks, followed by an 8-week open-label phase with sacubitril/valsartan. Primary endpoint was change from baseline in mean activity counts during the most active 30 min/day at week 8. The key secondary endpoint was change in mean nightly activity counts/minute from baseline to week 8. Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) was an exploratory endpoint.
RESULTS


There were no detectable differences between groups in geometric mean ratio of activity counts during the most active 30 min/day at week 8 compared with baseline (0.9456 [sacubitril/valsartan:enalapril]; 95% confidence interval [CI] 0.8863-1.0088; P = 0.0895) or in mean change from baseline in activity during sleep (difference: 2.038 counts/min; 95% CI - 0.062 to 4.138; P = 0.0570). Change from baseline to week 8 in KCCQ-23 was 2.89 for sacubitril/valsartan and 4.19 for enalapril, both nonsignificant.
CONCLUSIONS


In AWAKE-HF, no detectable differences in activity and sleep were observed when comparing sacubitril/valsartan with enalapril in patients with HFrEF using a wearable biosensor.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02970669.",2020,There were no detectable differences between groups in geometric mean ratio of activity counts during the most active 30 min/day at week 8 compared with baseline (0.9456 [sacubitril/valsartan:,"['patients who have heart failure with reduced ejection fraction (HFrEF', 'patients with HFrEF (n\u2009=\u2009140', 'patients with HFrEF using a wearable biosensor']","['sacubitril/valsartan', 'valsartan', 'sacubitril/valsartan versus enalapril', 'sacubitril/valsartan or enalapril', 'enalapril']","['activity and sleep', 'geometric mean ratio of activity counts', 'Daily Physical Activity and Sleep in Heart Failure', 'mean nightly activity counts', 'mean activity counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0600364', 'cui_str': 'Biosensors'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",140.0,0.389555,There were no detectable differences between groups in geometric mean ratio of activity counts during the most active 30 min/day at week 8 compared with baseline (0.9456 [sacubitril/valsartan:,"[{'ForeName': 'Raj M', 'Initials': 'RM', 'LastName': 'Khandwalla', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Medical Care Foundation, Cedars-Sinai Heart Institute, 8501 Wilshire Ave, Beverly Hills, California, 90211, United States. Raj.Khandwalla@cshs.org.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grant', 'Affiliation': 'Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ, 07936, USA.'}, {'ForeName': 'Kade', 'Initials': 'K', 'LastName': 'Birkeland', 'Affiliation': 'Department of Cardiology, Cedars-Sinai, 127 S San Vicente Blvd a3600, Los Angeles, CA, 90048, USA.'}, {'ForeName': 'J Thomas', 'Initials': 'JT', 'LastName': 'Heywood', 'Affiliation': 'Division of Cardiovascular Medicine, Scripps Clinic, 10666 N Torrey Pines Rd, San Diego, CA, 92037, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Fombu', 'Affiliation': 'Previously Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, San Diego School of Medicine, University of California, 4520 Executive Drive, San Diego, CA, 92121, USA.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Steinhubl', 'Affiliation': 'Digital Medicine, Scripps Research Translational Science Institute, 3344 North Torrey Pines Court, Suite 300, San Diego, CA, 92037, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","American journal of cardiovascular drugs : drugs, devices, and other interventions",['10.1007/s40256-020-00440-y']
3001,32973606,Different Visualizations Cause Different Strategies When Dealing With Bayesian Situations.,"People often struggle with Bayesian reasoning. However, previous research showed that people's performance (and rationality) can be supported by the way the statistical information is represented. First, research showed that using natural frequencies instead of probabilities as the format of statistical information significantly increases people's performance in Bayesian situations. Second, research also revealed that people's performance increases through using visualization. We have built our paper on existing research in this field. Our main aim was to analyze people's strategies in Bayesian situations that are erroneous even though statistical information is represented as natural frequencies and visualizations. In particular, we compared two pairs of visualization with similar numerical information (tree diagram vs. unit square, and double-tree diagram vs. 2 × 2-table) concerning their impact on people's erroneous strategies in Bayesian situations. For this aim, we conducted an experiment with 540 university students. The students were randomly assigned to four conditions defined by the four different visualizations of statistical information. The students were asked to indicate a fraction in response to four Bayesian situations. We documented the numerator and denominator of the students' responses representing a basic set and a subset in a Bayesian situation. Our results showed that people's erroneous strategies are highly dependent on visualization. A central finding was that the visualization's characteristic of making the nested-sets structure of a Bayesian situation transparent has a facilitating effect on people's Bayesian reasoning. For example, compared to the unit square, a tree diagram does not explicitly visualize the set-subset relations that are relevant in a Bayesian situation. Accordingly, compared to a unit square, a tree diagram partly hinders people in finding the correct denominator in a Bayesian situation, and, in particular, triggers selecting a wrong numerator. By analyzing people's erroneous strategies in Bayesian situations, we contribute to investigating approaches to facilitate Bayesian reasoning and to further develop the teaching of Bayesian reasoning.",2020,A central finding was that the visualization's characteristic of making the nested-sets structure of a Bayesian situation transparent has a facilitating effect on people's Bayesian reasoning.,['540 university students'],[],[],"[{'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],[],,0.0251853,A central finding was that the visualization's characteristic of making the nested-sets structure of a Bayesian situation transparent has a facilitating effect on people's Bayesian reasoning.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Eichler', 'Affiliation': 'Institute of Mathematics, University of Kassel, Kassel, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Böcherer-Linder', 'Affiliation': 'Institute of Mathematics, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Vogel', 'Affiliation': 'Institute of Mathematics and Informatics, University of Education Heidelberg, Heidelberg, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01897']
3002,32973614,Responding to the Spiritual Needs of Palliative Care Patients: A Randomized Controlled Trial to Test the Effectiveness of the Kibo Therapeutic Interview.,"Context


The WHO recognizes the need to attend to patients' spiritual needs as being fundamental to comprehensive and high-quality end-of-life care. Spiritual needs must be attended to since the resolution of biological and psychosocial issues is insufficient to reduce patients' suffering. Associations have been found between spiritual needs and other variables of importance for patients in palliative care. Despite the consensus that exists regarding the importance of assessing and attending to spiritual needs, professionals encounter many difficulties in attempting to do so.
Objectives


Our study aims to demonstrate the benefits that the Kibo therapeutic interview in palliative care patients can have for spirituality, demoralization, and resilience.
Methods


A parallel randomized controlled trial of two groups was undertaken. Information on 60 palliative care patients during pre- and post-intervention time points was gathered.
Results


ANOVAs showed a statistically significant effect of the intervention on the dimension of transpersonal spirituality. The ANCOVA for the effect of the intervention on resilience also pointed to its effectiveness. When the means of demoralization were examined, a higher decrease in the levels of demoralization for patients in the intervention group was observed, when compared to patients in the control group.
Conclusion


Our findings point to this interview as an effective means to attend to the spiritual needs of palliative patients, reducing demoralization and increasing resilience. Future research could focus on a broader sample and on the effects of this interview on family caregivers, mourners, and health care professionals.
Clinical Trial Registration Number


https://clinicaltrials.gov/ct2/show/ Identifier NCT03995095.",2020,"When the means of demoralization were examined, a higher decrease in the levels of demoralization for patients in the intervention group was observed, when compared to patients in the control group.
","['Palliative Care Patients', 'palliative care patients', '60 palliative care patients during pre- and post-intervention time points was gathered']",['https://clinicaltrials.gov/ct2/show'],"['levels of demoralization', 'dimension of transpersonal spirituality']","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0233498', 'cui_str': 'Demoralization'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}]",60.0,0.0563085,"When the means of demoralization were examined, a higher decrease in the levels of demoralization for patients in the intervention group was observed, when compared to patients in the control group.
","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Soto-Rubio', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Faculty of Psychology, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Perez-Marin', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Faculty of Psychology, University of Valencia, Valencia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rudilla', 'Affiliation': 'Air Liquide Healthcare, Valencia, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Galiana', 'Affiliation': 'Department of Methodology of Experimental and Social Sciences, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': 'Department of Methodology of Experimental and Social Sciences, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fombuena', 'Affiliation': 'Dr. Moliner Hospital, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Barreto', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Faculty of Psychology, University of Valencia, Valencia, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01979']
3003,32974062,Orthodontic Bond Strength Comparison between Two Filled Resin Sealants.,"Objective


Sealants are used in orthodontics to help prevent demineralization during treatment. This study aimed to determine if there is a difference in the shear bond strength (SBS) between 2 different resin sealants bonded to teeth.
Methods


Extracted human premolars (n=20/group) were randomly divided and prepared by acid etching, followed by application of primer or sealant. Group 1, the control group, used Transbond XT Primer (3M Unitek). Groups 2 and 3 were prepared with the sealants L.E.D. Pro Seal (Reliance Orthodontic Products) and Opal Seal (Opal Orthodontics) as the respective primers. Transbond XT Adhesive was applied to a stainless steel bracket and bonded to each tooth. Each group was stored in distilled water at 37°C for 48 hours before. SBS was measured using a universal testing machine, and the adhesive remnant index (ARI) was scored.
Results


The SBS (MPa) of the groups was as follows: Group 1 (Transbond): 20.1±6.0; Group 2 (Pro Seal): 16.5±4.8; and Group 3 (Opal Seal): 15.7±3.9. The SBS of Transbond XT Primer was significantly greater than that of Opal Seal (p<0.05/analysis of variance-Tukey), while Pro Seal and Opal Seal sealants were not significantly different from each other (p<0.05). The Opal Seal group had significantly greater ARI scores, indicating that more adhesive remained on the teeth after debonding.
Conclusion


Opal Seal and Pro Seal sealants have similar SBS but generally exhibit lower bond strengths than an adhesive primer.",2020,The SBS of Transbond XT Primer was significantly greater than that of Opal Seal,"['Methods\n\n\nExtracted human premolars (n=20/group', '2 different resin sealants bonded to teeth']",['Opal Seal'],"['ARI scores', 'shear bond strength (SBS', 'SBS']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0729415', 'cui_str': 'Sealant'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0036492', 'cui_str': 'Seal'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",,0.036205,The SBS of Transbond XT Primer was significantly greater than that of Opal Seal,"[{'ForeName': 'James Anthony', 'Initials': 'JA', 'LastName': 'Kolstad', 'Affiliation': 'Orthodontic Resident, Department of Developmental Sciences, Marquette University School of Dentistry, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Danielle Lynn', 'Initials': 'DL', 'LastName': 'Cianciolo', 'Affiliation': 'Marquette University School of Dentistry, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Alan James', 'Initials': 'AJ', 'LastName': 'Ostertag', 'Affiliation': 'Private Practice, Eau Claire, Wisconsin, USA.'}, {'ForeName': 'David William', 'Initials': 'DW', 'LastName': 'Berzins', 'Affiliation': 'General Dental Sciences, Marquette University School of Dentistry, Milwaukee, Wisconsin, USA.'}]",Turkish journal of orthodontics,['10.5152/TurkJOrthod.2020.19049']
3004,32974119,Influence of Rosa damascena hydrosol on skin flora (contact culture) after hand-rubbing.,"Aim and Introduction:   Rosa damascena  is one of the most well-known species of the Rosaceae family and is widely used in the food and perfume industry. Rose hydrosol is a product which is produced by distillation of rose petals. There is very little research about the antimicrobial effect of rose hydrosol. In this study, we aimed to investigate the antibacterial effect of  Rosa damascena  hydrosol  in vivo .  Method:  45 adult volunteers who were not healthcare workers were included in this study. Exclusion criteria included existing skin disorders or lacerations, pregnancy, presence of nail polish, recent handwashing or use of antiseptic lotion/soap in the last week, and antibiotic use in the last 3 months. At baseline, each subject was asked to rub the fingertips of the dominant hand on a sheep-blood agar plate. The subjects were randomly divided into two groups: one group rubbed their hands with 3 mL of alcohol-based hand antiseptic and the other group with 3 mL of rose hydrosol. Following sample collection, the subjects were asked to rub their hands according to the World Health Organization's (WHO) ""How to Hand Rub"" technique. After the hand-rubbing sequence, the hands were allowed to air-dry and fingertip sampling was performed. Culture plates were evaluated by a microbiologist blinded to group assignment. Rose hydrosol was analysed by gas chromatography/mass spectrometry.  Results:  The main components of rose hydrosol are phenyl ethyl alcohol, beta-citronellol and geraniol. Of the total of 45 participants, 23 were included in rose hydrosol group and 22 in the alcohol-based hand-rub group. The colony counts decreased significantly in the alcohol-based solution group after hand-rubbing, whereas there was no significant reduction in the rose hydrosol group.  Conclusion:  A number of studies have shown good antimicrobial activity in rose products, especially in rose oil, but we found no antibacterial effect of rose hydrosol after hand-rubbing. However, it must be borne in mind that the amount and types of rose hydrosol components are highly influenced by the given agro-meteorological conditions and technological production methods.",2020,"The colony counts decreased significantly in the alcohol-based solution group after hand-rubbing, whereas there was no significant reduction in the rose hydrosol group.  ","['Exclusion criteria included existing skin disorders or lacerations, pregnancy, presence of nail polish, recent handwashing or use of', '45 adult volunteers who were not healthcare workers', '45 participants, 23 were included in rose hydrosol group and 22 in the alcohol-based hand-rub group']","['one group rubbed their hands with 3 mL of alcohol-based hand antiseptic and the other group with 3 mL of rose hydrosol', 'Rosa damascena hydrosol', 'antiseptic lotion/soap', ""rub their hands according to the World Health Organization's (WHO""]","['colony counts', 'skin flora (contact culture']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0043246', 'cui_str': 'Laceration'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0304644', 'cui_str': 'Nail polish'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C0368993', 'cui_str': 'Colony count'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]",45.0,0.021848,"The colony counts decreased significantly in the alcohol-based solution group after hand-rubbing, whereas there was no significant reduction in the rose hydrosol group.  ","[{'ForeName': 'Gulsum Iclal', 'Initials': 'GI', 'LastName': 'Bayhan', 'Affiliation': 'Yildirim Beyazit University, Faculty of Medicine, Yenimahalle Educational and Training Hospital, Ankara, Turkey.'}, {'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Gumus', 'Affiliation': 'Yildirim Beyazit University, Yenimahalle Educational and Training Hospital, Microbiology, Ankara, Turkey.'}, {'ForeName': 'Basak', 'Initials': 'B', 'LastName': 'Alan', 'Affiliation': 'Yildirim Beyazit University, Faculty of Medicine, General Pediatrics, Ankara, Turkey.'}, {'ForeName': 'Isil Kubra', 'Initials': 'IK', 'LastName': 'Savas', 'Affiliation': 'Yildirim Beyazit University, Faculty of Medicine, General Pediatrics, Ankara, Turkey.'}, {'ForeName': 'Saliha Aysenur', 'Initials': 'SA', 'LastName': 'Cam', 'Affiliation': 'Yildirim Beyazit University Faculty of Medicine, Pharmacology, Ankara, Turkey.'}, {'ForeName': 'Elif Ayca', 'Initials': 'EA', 'LastName': 'Sahin', 'Affiliation': 'Yildirim Beyazit University, Yenimahalle Educational and Training Hospital, Microbiology, Ankara, Turkey.'}, {'ForeName': 'Seyfullah Oktay', 'Initials': 'SO', 'LastName': 'Arslan', 'Affiliation': 'Yildirim Beyazit University Faculty of Medicine, Pharmacology, Ankara, Turkey.'}]",GMS hygiene and infection control,['10.3205/dgkh000356']
3005,32974236,Comparing peer education with TBL workshop in (EBM) teaching.,"Background:  Evidence-based medicine is one of the most important topics in medical sciences that requires a proper teaching method. Very few studies have evaluated EBM education outcomes through peers and TBL workshops. The purpose of this study was to compare the effect of evidence-based medicine (EBM) education through peers with TBL workshop method in medical students.  Methods:  This quasi-experimental study was conducted on 42 medical students of the Faculty of Medicine in Iran University of Medical Sciences (IUMS) in 2019 who were selected through convenience sampling. Students were divided into 2 experimental and control groups based on the randomized blocking method. The data collection tools were 2 questioners that evaluated EBM knowledge and satisfaction in both intervention and control groups. The knowledge of students was compared using pretest and posttest and their satisfaction was evaluated at the end of the TBL workshop and peer education. Data were analyzed by SPSS software and descriptive tests (t test and ANOVA), and significance level was set at 0.95.  Results:  A significant difference was found between the level of basic knowledge (pretest) and secondary knowledge (posttest) in the EBM education through TBL workshop method compared to peer method. The average scores gained by students in TBL workshop were 3.8 more than the peer teaching method. The results of the Satisfaction Questionnaire were 74% in control group and 86% in the experimental group.  Conclusion:  EBM education through TBL workshop both increased students' knowledge and satisfaction compared to peer education. Thus, it can be concluded that providing EBM education by expert and qualified teachers through face to face teaching strategy can be effective in knowledge translation. However, peers can participate in educational sessions as facilitators.",2020,A significant difference was found between the level of basic knowledge (pretest) and secondary knowledge (posttest) in the EBM education through TBL workshop method compared to peer method.,"['peers with TBL workshop method in medical students', '42 medical students of the Faculty of Medicine in Iran University of Medical Sciences (IUMS) in 2019 who were selected through convenience sampling']","['peer education with TBL workshop in (EBM) teaching', 'evidence-based medicine (EBM) education']","[""students' knowledge and satisfaction"", 'Satisfaction Questionnaire', 'level of basic knowledge (pretest) and secondary knowledge', 'EBM knowledge and satisfaction']","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0376537', 'cui_str': 'Medicine, Evidence-Based'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0795974', 'cui_str': 'Epidermolysis Bullosa, Macular Type'}]",42.0,0.0159688,A significant difference was found between the level of basic knowledge (pretest) and secondary knowledge (posttest) in the EBM education through TBL workshop method compared to peer method.,"[{'ForeName': 'Ghobad', 'Initials': 'G', 'LastName': 'Ramezani', 'Affiliation': 'Center of Educational Research in Medical Science (CERMS), Department of Medical Education, School of Medicine, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Norouzi', 'Affiliation': 'Center of Educational Research in Medical Science (CERMS), Department of Medical Education, School of Medicine, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Eshagh', 'Initials': 'E', 'LastName': 'Moradi', 'Affiliation': 'Center of Educational Research in Medical Science (CERMS), Department of Medical Education, School of Medicine, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Ghadir', 'Initials': 'G', 'LastName': 'Pourbairamian', 'Affiliation': 'Center of Educational Research in Medical Science (CERMS), Department of Medical Education, School of Medicine, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Aalaa', 'Affiliation': 'Center of Educational Research in Medical Science (CERMS), Department of Medical Education, School of Medicine, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Alizadeh', 'Affiliation': 'Center of Educational Research in Medical Science (CERMS), Department of Medical Education, School of Medicine, Iran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Sohrabi', 'Affiliation': 'Center of Educational Research in Medical Science (CERMS), Department of Medical Education, School of Medicine, Iran University of Medical Science, Tehran, Iran.'}]",Medical journal of the Islamic Republic of Iran,['10.34171/mjiri.34.70']
3006,32974411,The Effect of Graft Harvest and Skin Incision Angle on Sensory Disturbance in ACL Reconstruction With Semitendinosus-Gracilis Tendon Graft: A Randomized Controlled Trial and Cadaveric Study.,"Background


Injury to the inferior branch of the saphenous nerve (IBSN) and the subsequent loss of skin sensation after anterior cruciate ligament (ACL) reconstruction are common. The literature suggests that the incision angle may affect the incidence and area of loss of skin sensation.
Purpose


To determine whether there is a difference in the incidence and area of altered sensory loss on the tibia between vertical (VI) and oblique (OI) incisions for semitendinosus-gracilis tendon graft harvest during ACL reconstruction. The cadaveric component was designed to determine whether there is a ""safe zone"" for incision by identifying the location and number of branches of the IBSN.
Study Design


Randomized controlled trial; Level of evidence, 2.
Methods


Patients (n = 37) were randomized to receive either VI or OI. Incidence and area of altered skin sensation were documented during at least 1 postoperative visit. In addition, 18 cadaveric knees were dissected.
Results


The presence or absence of hypoesthesia did not differ between groups postoperatively. Although no statistical differences between groups were seen in the total area of perceived altered skin sensation at 3 ( P  = .57), 6 ( P  = .08), 12 ( P  = .65), and 24 months ( P  = .27), data demonstrated a trend toward VI participants having a larger area of hypoesthesia at every time point. Among the 18 cadaveric specimens, 4 variations in the distribution of IBSN were noted: 18 (100%) had 1 branch, 14 (78%) had 2 branches, 6 (33%) had 3 branches, and 1 (6%) had 4 branches. No safe zone for incision could be identified.
Conclusion


No difference was found between a vertical and an oblique incision with respect to incidence or area of sensory loss. Furthermore, it was not possible to identify a safe zone that would prevent transection of all nerves branches of the IBSN based on the cadaveric component of this study.",2020,"Although no statistical differences between groups were seen in the total area of perceived altered skin sensation at 3 ( P  = .57), 6 ( P  = .08), 12 ( P  = .65), and 24 months ( P  = .27), data demonstrated a trend toward VI participants having a larger area of hypoesthesia at every time point.","['18 cadaveric knees were dissected', 'Patients (n = 37']","['Graft Harvest and Skin Incision Angle', 'tibia between vertical (VI) and oblique (OI) incisions', 'Semitendinosus-Gracilis Tendon Graft', 'VI or OI', 'saphenous nerve (IBSN', 'ACL Reconstruction']","['skin sensation', 'total area of perceived altered skin sensation', 'Incidence and area of altered skin sensation', 'incidence and area of loss of skin sensation', 'distribution of IBSN', 'presence or absence of hypoesthesia', 'incidence or area of sensory loss']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0448621', 'cui_str': 'Tendon of gracilis'}, {'cui': 'C0228919', 'cui_str': 'Structure of saphenous nerve'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0522057', 'cui_str': 'Numbness of skin'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0228919', 'cui_str': 'Structure of saphenous nerve'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0278134', 'cui_str': 'Absence of sensation'}]",37.0,0.0940578,"Although no statistical differences between groups were seen in the total area of perceived altered skin sensation at 3 ( P  = .57), 6 ( P  = .08), 12 ( P  = .65), and 24 months ( P  = .27), data demonstrated a trend toward VI participants having a larger area of hypoesthesia at every time point.","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Leiter', 'Affiliation': 'Pan Am Clinic Foundation, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Peeler', 'Affiliation': 'Pan Am Clinic Foundation, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'McRae', 'Affiliation': 'Pan Am Clinic Foundation, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wiens', 'Affiliation': 'Pan Am Clinic Foundation, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hammond', 'Affiliation': 'Pan Am Clinic Foundation, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Froese', 'Affiliation': 'Pan Am Clinic Foundation, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'MacDonald', 'Affiliation': 'Pan Am Clinic Foundation, Winnipeg, Manitoba, Canada.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120948954']
3007,32974614,Protocol for comparing two training approaches for primary care professionals implementing the Safe Environment for Every Kid (SEEK) model.,"Background


Child maltreatment (CM) is a major public health problem, affecting many lives, in the short and long term, and costing individuals, families, and society dearly. There is a need for broad implementation of evidence-based preventive interventions, such as the Safe Environment for Every Kid (SEEK) model, developed for pediatric primary care. Primary care offers an excellent opportunity to help address prevalent psychosocial problems (e.g., parental depression) that are risk factors for CM. By addressing such problems, SEEK can strengthen families and support parents; promote children's health, development, and safety; help prevent CM; and benefit the health of the US population. This study will examine intervention strategies for optimizing SEEK's adoption, implementation, and sustainment, and its effectiveness in preventing CM.Despite strong evidence from two federally funded randomized controlled trials, SEEK has not been widely adopted. The goal of this study is to examine technology-driven implementation strategies to scale-up SEEK-in pediatric and family medicine primary care settings. The aims are to (1) evaluate the effectiveness of training strategies on SEEK's implementation in primary care practices, (2) evaluate barriers and facilitators to successful implementation and sustainment of SEEK, and (3) examine the model's effectiveness in preventing CM and the economic costs of implementing SEEK.
Methods


This randomized type III hybrid mixed methods design will examine how advances in medical training can bolster SEEK's adoption and implementation in pediatric and family medicine practices in different regions of the USA. These are independent online training and in-depth structured training via a quality improvement project, approved by the American Boards of Pediatrics and of Family Medicine. We will also evaluate SEEK online , software that assists primary care practitioners implement the model, and a ""Traditional"" paper and pencil strategy for their impact on implementation. The study uses the EPIS framework and the Universal Stages of Implementation Completion, quantitative measures, qualitative interviews, and data abstracted from electronic health records.
Discussion


The knowledge gained should improve pediatric primary care to better address prevalent social determinants of health, benefiting many children and families. The outcomes should enhance the field of implementation science and guide future interventions in primary care.
Trial registration


NCT03642327, Clinical Trials, registered August 21, 2018.",2020,"We will also evaluate SEEK online , software that assists primary care practitioners implement the model, and a ""Traditional"" paper and pencil strategy for their impact on implementation.",[],['\n\n\nChild maltreatment (CM'],[],[],"[{'cui': 'C0008060', 'cui_str': 'Child abuse'}]",[],,0.0540609,"We will also evaluate SEEK online , software that assists primary care practitioners implement the model, and a ""Traditional"" paper and pencil strategy for their impact on implementation.","[{'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Dubowitz', 'Affiliation': 'Division of Child Protection, Department of Pediatrics, University of Maryland School of Medicine, 520 W. Lombard St, Baltimore, MD 21201 USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Saldana', 'Affiliation': 'Oregon Social Learning Center, 10 Shelton McMurphey Blvd., Eugene, OR 97401 USA.'}, {'ForeName': 'Laurence A', 'Initials': 'LA', 'LastName': 'Magder', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, 655 W. Baltimore St., Baltimore, MD 21201 USA.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Palinkas', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work, University of Southern California, 669 W. 34th Street, MC0411, Los Angeles, CA 90089-0411 USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Landsverk', 'Affiliation': 'Oregon Social Learning Center, 10 Shelton McMurphey Blvd., Eugene, OR 97401 USA.'}, {'ForeName': 'Rose L', 'Initials': 'RL', 'LastName': 'Belanger', 'Affiliation': 'Division of Child Protection, Department of Pediatrics, University of Maryland School of Medicine, 520 W. Lombard St, Baltimore, MD 21201 USA.'}, {'ForeName': 'Ugonna S', 'Initials': 'US', 'LastName': 'Nwosu', 'Affiliation': 'Division of Child Protection, Department of Pediatrics, University of Maryland School of Medicine, 520 W. Lombard St, Baltimore, MD 21201 USA.'}]",Implementation science communications,['10.1186/s43058-020-00059-9']
3008,32974618,3D Evaluation of Accuracy of Tooth Preparation for Laminate Veneers Assisted by Rigid Constraint Guides Printed by Selective Laser Melting.,"OBJECTIVE


To design and fabricate 3D-printed rigid constraint guides for the tooth preparation for laminate veneers and to evaluate the accuracy of guide-assisted preparation.
METHODS


Twenty maxillary right central incisor resin artificial teeth were randomly divided into two equal groups and prepared for laminate veneers. Tooth preparations were performed, assisted by guides in the test group and by depth gauge burs in the control group, and both were finished by freehand operation. The typodonts were 3D scanned before preparation, after initial preparation and after final preparation. The tooth preparation depths at each step, including initial preparation depth, final preparation depth and loss of tooth tissue during polishing, were measured by 3D deviation analysis. Statistical analyses were conducted to investigate differences.
RESULTS


The initial preparation depth was 0.488 mm (median, quartile 0.013 mm) in the test group and 0.521 mm (median, quartile 0.013 mm) in the control group. A statistically significant difference was found between them (P < 0.05). The final preparation depth in the test group (0.547 ± 0.029 mm) was significantly less than that in the control group (0.599 ± 0.051 mm) (P < 0.05), and closer to the predesigned value (0.5 mm). There was no statistically significant difference in the loss of tooth tissue during polishing between the test group (0.072 ± 0.023 mm) and the control group (0.089 ± 0.038 mm) (P > 0.05).
CONCLUSION


In maxillary central incisors, the tooth preparation for laminate veneers could be conducted using 3D-printed rigid constraint guides, the accuracy of which is better than that of depth gauge burs.",2020,"The initial preparation depth was 0.488 mm (median, quartile 0.013 mm) in the test group and 0.521 mm (median, quartile 0.013 mm) in the control group.",['Twenty maxillary right central incisor resin artificial teeth'],[],"['loss of tooth tissue', 'initial preparation depth']","[{'cui': 'C0227042', 'cui_str': 'Structure of maxillary right central incisor tooth'}, {'cui': 'C2363605', 'cui_str': 'Resin artificial teeth'}]",[],"[{'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",20.0,0.0485273,"The initial preparation depth was 0.488 mm (median, quartile 0.013 mm) in the test group and 0.521 mm (median, quartile 0.013 mm) in the control group.","[{'ForeName': 'Zhong Yi', 'Initials': 'ZY', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'He Fei', 'Initials': 'HF', 'LastName': 'Bai', 'Affiliation': ''}, {'ForeName': 'Yi Jiao', 'Initials': 'YJ', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Hong Qiang', 'Initials': 'HQ', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Yu Chun', 'Initials': 'YC', 'LastName': 'Sun', 'Affiliation': ''}]",The Chinese journal of dental research : the official journal of the Scientific Section of the Chinese Stomatological Association (CSA),['10.3290/j.cjdr.a45222']
3009,32722707,Differences in the acceptance of wife abuse among ethnic minority Garo and Santal and mainstream Bengali communities in rural Bangladesh.,"Studies on wife abuse in Bangladesh predominantly include the mainstream Bengali population, although there are at least 27 ethnic minority communities including a few 'female-centered' matrilineal groups living in the country. This study explored ethnic differences in the attitudinal acceptance of wife abuse among matrilineal ethnic minority Garo, patrilineal ethnic minority Santal, and mainstream patriarchal Bengali communities in rural Bangladesh. Adopting a cross-sectional design, the study included 1,929 women and men randomly selected from 24 Garo, Santal, and Bengali villages. Multivariate Poisson regression was performed to predict the number of contextual events, where the respondents attitudinally endorsed wife abuse. Of the sample, 33.2% were from Garo, 33.2% from Santal, and 33.6% from the Bengali communities. The acceptance of wife abuse was high in the sample; specifically, 34.1% of the respondents accepted physical wife abuse, 67.5% accepted emotional abuse, and 71.6% accepted any abuse (either physical or emotional) at least on one contextual reason provided in a 10-item scale. The mean for accepting any abuse was 3.0 (SD = 2.8), emotional abuse 2.3 (SD = 2.2), and physical abuse 0.8 (SD = 1.4). The study showed that the rates of accepting any abuse and physical abuse were respectively 16% and 56% lower among Garo as well as 14% and 33% lower among Santal than that of the Bengali community. Data also revealed that individual level factors like younger age, higher education, prestigious occupation as well as family level factors such as higher income, female mobility, and female family authority were inversely associated with the acceptance of wife abuse in the sample. It appears that the gender regime of a society has a great influence on the attitudes toward wife abuse. We argue that a comprehensive socio-cultural transformation of the patriarchal societies into a gender equal order is imperative for the prevention of widespread wife abuse in the country.",2020,The study showed that the rates of accepting any abuse and physical abuse were respectively 16% and 56% lower among Garo as well as 14% and 33% lower among Santal than that of the Bengali community.,"['1,929 women and men randomly selected from 24 Garo, Santal, and Bengali villages', 'wife abuse among matrilineal ethnic minority Garo, patrilineal ethnic minority Santal, and mainstream patriarchal Bengali communities in rural Bangladesh', ""27 ethnic minority communities including a few 'female-centered' matrilineal groups living in the country""]",[],"['rates of accepting any abuse and physical abuse', 'acceptance of wife abuse']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0004981', 'cui_str': 'Bengali language'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0043175', 'cui_str': 'Wife Abuse'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0454664', 'cui_str': 'Country'}]",[],"[{'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C1621955', 'cui_str': 'Physical abuse'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0043175', 'cui_str': 'Wife Abuse'}]",1929.0,0.0131083,The study showed that the rates of accepting any abuse and physical abuse were respectively 16% and 56% lower among Garo as well as 14% and 33% lower among Santal than that of the Bengali community.,"[{'ForeName': 'Rabiul', 'Initials': 'R', 'LastName': 'Karim', 'Affiliation': 'Department of Social Work, University of Rajshahi, Rajshahi, Bangladesh.'}, {'ForeName': 'Tanzima Zohra', 'Initials': 'TZ', 'LastName': 'Habib', 'Affiliation': 'Department of Social Work, University of Rajshahi, Rajshahi, Bangladesh.'}, {'ForeName': 'Sadequl', 'Initials': 'S', 'LastName': 'Arefin', 'Affiliation': 'Department of Social Work, University of Rajshahi, Rajshahi, Bangladesh.'}, {'ForeName': 'Hafijur', 'Initials': 'H', 'LastName': 'Rahman', 'Affiliation': 'Department of Social Work, University of Rajshahi, Rajshahi, Bangladesh.'}, {'ForeName': 'Suchona', 'Initials': 'S', 'LastName': 'Rahman', 'Affiliation': 'Department of Social Work, University of Rajshahi, Rajshahi, Bangladesh.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Swahnberg', 'Affiliation': 'Department of Health and Caring Sciences, Faculty of Health and Life Sciences, Linnaeus University, Kalmar, Sweden.'}]",PloS one,['10.1371/journal.pone.0236733']
3010,30199586,Identification and molecular characterization of allergenic non-specific lipid-transfer protein from durum wheat (Triticum turgidum).,"BACKGROUND


Common wheat (Triticum aestivum) and durum wheat (T. turgidum) are both involved in Baker's asthma (BA) and food allergy (FA) including wheat-dependent exercise-induced asthma (WDEIA). However, allergens in durum wheat have not been described, and the over-expression of T. turgidum non-specific lipid-transfer protein (nsLTPs) is considered to increase resistance to phytopathogens.
OBJECTIVE


To identify and assess the allergenicity of nsLTP from T. turgidum.
METHODS


Recombinant T. turgidum nsLTP Tri tu 14 was generated and tested for structural integrity (circular dichroism-spectroscopy) and purity (SDS-PAGE). Thirty-two wheat allergic patients were enrolled: 20 Spanish patients (BA) with positive bronchial challenge to wheat flour, and 12 Italian patients (wheat FA/WDEIA) with positive double-blind placebo-controlled food challenge/open food challenge (OFC) to pasta. IgE values to wheat, Tri tu 14, Tri a 14 (T. aestivum) and Pru p 3 (P. persica) were determined by ImmunoCAP testing. Allergenic potency (in vitro mediator release) and IgE cross-reactivity were investigated.
RESULTS


Tri tu 14 was found to share 49% and 52% amino acid identity with Tri a 14 and Pru p 3, respectively. Among 25 Tri a 14 CAP positive sera, 23 (92%) were reactive to wheat extract, 22 (88%) to Tri tu 14 and 20 (80%) to Pru p 3. The correlation between Tri a 14 and Tri tu 14 specific IgE levels was r = 0.97 (BA) and r = 0.93 (FA/WDEIA), respectively. FA/WDEIA patients showed higher specific IgE values to Tri tu 14 and Pru p 3 than BA patients. Tri tu 14 displayed allergenic activity by mediator release from effector cells and IgE cross-reactivity with Pru p 3. The degree of IgE cross-reactivity between the two wheat nsLTPs varied between individual patients.
CONCLUSIONS AND CLINICAL RELEVANCE


Sensitization to Tri tu 14 likely appears to be more important in wheat FA/WDEIA than in BA. Over-expression of Tri tu 14 in wheat would represent a risk for patients with nsLTP-mediated FA.",2019,FA/WDEIA patients showed higher specific IgE values to Tri tu 14 and Pru p 3 than BA patients.,"['Recombinant T.\xa0turgidum nsLTP', 'Thirty-two wheat allergic patients were enrolled: 20 Spanish patients (BA) with positive bronchial challenge to wheat flour, and 12 Italian patients (wheat FA/WDEIA) with positive double-blind', 'patients with nsLTP-mediated FA']",['placebo-controlled food challenge/open food challenge (OFC) to pasta'],"['degree of IgE cross-reactivity', 'Allergenic potency', 'specific IgE values']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0264480', 'cui_str': ""Bakers' asthma""}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006265', 'cui_str': 'Bronchial provocation test'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0004099', 'cui_str': 'Exercise-induced asthma'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0010357', 'cui_str': 'Cross Reactions'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0384805,FA/WDEIA patients showed higher specific IgE values to Tri tu 14 and Pru p 3 than BA patients.,"[{'ForeName': 'Hela', 'Initials': 'H', 'LastName': 'Safi', 'Affiliation': 'Laboratory of Biotechnology and Plant Improvement, Centre of Biotechnology, Sfax, Tunisia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wangorsch', 'Affiliation': 'Molecular Allergology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Lidholm', 'Affiliation': 'Thermo Fisher Scientific, Uppsala, Sweden.'}, {'ForeName': 'Faiçal', 'Initials': 'F', 'LastName': 'Brini', 'Affiliation': 'Laboratory of Biotechnology and Plant Improvement, Centre of Biotechnology, Sfax, Tunisia.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Spiric', 'Affiliation': 'Division Allergology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Rihs', 'Affiliation': 'Institute for Prevention and Occupational Medicine of the German Social Accident Insurance (IPA), Institute of the Ruhr-University Bochum, Molecular Genetics, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Vieths', 'Affiliation': 'Molecular Allergology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Armentia', 'Affiliation': 'Hospital Universitario Río Hortega, Valladolid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Farioli', 'Affiliation': 'Department of Laboratory Medicine, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Diaz-Perales', 'Affiliation': 'Departamento de Biotecnología-Biología Vegetal, E. T.S. Ingenieros Agrónomos/Centro de Biotecnología y Genómica de Plantas (CBGP, UPM-INIA) Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Elide A', 'Initials': 'EA', 'LastName': 'Pastorello', 'Affiliation': 'Department of Allergology and Immunology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Scheurer', 'Affiliation': 'Molecular Allergology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13271']
3011,30660873,Treatment effect of switching from intravenous to subcutaneous C1-inhibitor for prevention of hereditary angioedema attacks: COMPACT subgroup findings.,,2019,,[],['subcutaneous C1-inhibitor'],[],[],"[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 esterase inhibitor antigen level'}]",[],,0.0356695,,"[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Craig', 'Affiliation': 'Penn State University, Department of Medicine and Pediatrics, Hershey, Pa. Electronic address: tcraig@pennstatehealth.psu.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lumry', 'Affiliation': 'AARA Research Center, Dallas, Texas.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cicardi', 'Affiliation': 'University of Milan, Department of Medicine, Milan, Italy.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Zuraw', 'Affiliation': 'Department of Medicine, UC San Diego, La Jolla, Calif.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'University of Cincinnati College of Medicine and Bernstein Clinical Research Center, LLC, Cincinnati, Ohio.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Birmingham, Ala.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Jacobs', 'Affiliation': 'Allergy and Asthma Clinical Research, Inc., Walnut Creek, Calif.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'Division of Rheumatology, Allergy & Immunology, Department of Medicine, University of California, San Diego, La Jolla, Calif.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Manning', 'Affiliation': 'Medical Research of Arizona, Scottsdale, Ariz.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Massachusetts General Hospital, Department of Medicine, Boston, Mass.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Gower', 'Affiliation': 'Marycliff Clinical Research, Spokane, Wash.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Caballero', 'Affiliation': 'Allergy Department, Hospital La Paz Institute for Health Research (IdiPaz), Biomedical Research Network on Rare Diseases (CIBERER U754), Madrid, Spain.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Farkas', 'Affiliation': 'Hungarian Angioedema Reference Center, 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Feuersenger', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'CSL Behring, King of Prussia, Pa.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Machnig', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Longhurst', 'Affiliation': ""Department of Immunology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.01.007']
3012,30708143,H 1 -antihistamine inhibition of histamine- and codeine-induced wheals does not predict response in chronic cold urticaria.,,2019,,['chronic cold urticaria'],['histamine- and codeine'],[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0221207', 'cui_str': 'Urticaria due to cold'}]","[{'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0009214', 'cui_str': 'Codeine'}]",[],,0.0168722,,"[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Gorczyza', 'Affiliation': 'Department of Dermatology and Allergy, Allergie-Centrum Charité, Charité -Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Curto-Barredo', 'Affiliation': 'Department of Dermatology, Hospital del Mar, Institut Hospital del Mar d ́Investigacions Mediques(IMIM), Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Krause', 'Affiliation': 'Department of Dermatology and Allergy, Allergie-Centrum Charité, Charité -Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Martin K', 'Initials': 'MK', 'LastName': 'Church', 'Affiliation': 'Department of Dermatology and Allergy, Allergie-Centrum Charité, Charité -Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Hawro', 'Affiliation': 'Department of Dermatology and Allergy, Allergie-Centrum Charité, Charité -Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Metz', 'Affiliation': 'Department of Dermatology and Allergy, Allergie-Centrum Charité, Charité -Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Giménez-Arnau', 'Affiliation': 'Department of Dermatology, Hospital del Mar, Institut Hospital del Mar d ́Investigacions Mediques(IMIM), Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Department of Dermatology and Allergy, Allergie-Centrum Charité, Charité -Universitätsmedizin Berlin, Berlin, Germany. Electronic address: marcus.maurer@charite.de.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.01.030']
3013,31831201,An ecological momentary intervention incorporating personalised feedback to improve symptoms and social functioning in schizophrenia spectrum disorders.,"This study examined the feasibility and effectiveness of an interactive smartphone application that aimed to improve daily-life social functioning and symptoms in schizophrenia spectrum disorders (SZ) with Experience Sampling Method (ESM) derived personalised feedback.Two groups of outpatients with a diagnosis of SZ were included (one receiving ESM-derived personalised feedback (n = 27) and one without feedback (n = 23)) and used the interactive smartphone application for three weeks. Main outcomes were momentary symptoms and social functioning, as assessed by ESM questionnaires. Additionally, feasibility and user-friendliness of the application were assessed. The response rate was 64% for the ESM questionnaires. In the feedback group, participants indicated that on 49% of the ESM days they acted on at least one personalised feedback prompt per day. Momentary psychotic symptoms significantly decreased over time only in the feedback group. Momentary loneliness and questionnaire-assessed psychotic symptoms decreased over time, irrespective of feedback. Participants evaluated the app as user-friendly and understandable. Momentary personalised feedback may impact momentary psychosis in daily life. Feelings of loneliness and questionnaire-based measured psychotic symptoms may be more responsive to non-specific effects of daily-life self-monitoring, not requiring specific feedback. Ecological momentary interventions offer opportunities for accessible and effective interventions in SZ.",2020,Momentary psychotic symptoms significantly decreased over time only in the feedback group.,"['n\xa0=\xa023', 'schizophrenia spectrum disorders (SZ', 'schizophrenia spectrum disorders', 'Two groups of outpatients with a diagnosis of SZ were included (one receiving']","['ESM-derived personalised feedback (n\xa0=\xa027) and one without feedback ', 'ecological momentary intervention incorporating personalised feedback', 'interactive smartphone application']","['momentary symptoms and social functioning, as assessed by ESM questionnaires', 'Momentary psychotic symptoms', 'Momentary loneliness and questionnaire-assessed psychotic symptoms', 'response rate', 'Feelings of loneliness and questionnaire-based measured psychotic symptoms']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0343815,Momentary psychotic symptoms significantly decreased over time only in the feedback group.,"[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Hanssen', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, and Institute for Brain and Behaviour Amsterdam, Vrije Universiteit Amsterdam, the Netherlands. Electronic address: esther.hanssen@vu.nl.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Balvert', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, and Institute for Brain and Behaviour Amsterdam, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Oorschot', 'Affiliation': 'GGZ Delfland, Delft, The Netherlands.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Borkelmans', 'Affiliation': 'Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Os', 'Affiliation': 'Department of Psychiatry, Brain Centre Rudolf Magnus, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Delespaul', 'Affiliation': 'Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Centre, Maastricht, The Netherlands; Mondriaan Mental Health Trust, Heerlen, The Netherlands.'}, {'ForeName': 'Anne-Kathrin', 'Initials': 'AK', 'LastName': 'Fett', 'Affiliation': ""Department of Clinical, Neuro and Developmental Psychology, Faculty of Behavioural and Movement Sciences, and Institute for Brain and Behaviour Amsterdam, Vrije Universiteit Amsterdam, the Netherlands; Department of Psychology, City University of London, London, United Kingdom; CSI Lab, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychosis Studies, King's College London, London, United Kingdom.""}]",Psychiatry research,['10.1016/j.psychres.2019.112695']
3014,32456646,The association of hearing impairment and its severity with physical and mental health among Chinese middle-aged and older adults.,"BACKGROUND


Hearing impairment is a common chronic condition which can be closely related to people's health. However, current studies on this topic are quite limited in developing countries, and few with standardized audiometric measurement and multiple health outcomes. Therefore, we aimed to explore the association between hearing impairment and its severity with physical and mental health among Chinese middle-aged and older adults.
METHODS


We obtained data from two sources: (1) China Health and Retirement Longitudinal Study (CHARLS) 2011, 2013, and 2015, in which hearing impairment was measured by asking whether participants aged 45 years old had hearing problems; and (2) Hearing Survey 2019, the baseline survey of a randomized controlled trial conducted in Shandong Province of China, including 376 middle-aged and older participants. The severity of hearing impairment was identified by pure tone average of hearing thresholds at 0.5, 1, 2, and 4 kHz.
RESULTS


In CHARLS, 1248 (8.36%) participants suffered from hearing impairment at baseline, and hearing-impaired individuals were more likely to have chronic diseases, impaired activities of daily living (ADLs), impaired instrumental activities of daily living (IADLs) and depressive symptoms. For the 376 hearing-impaired participants in Hearing Survey 2019, 30.32, 38.30 and 31.38% of them had moderate, severe and profound hearing impairment, respectively. As the severity of hearing impairment increased, individuals were likely to have impaired ADLs, impaired IADLs and depressive symptoms.
CONCLUSIONS


Hearing impairment and its severity were closely related to multiple physical and mental health outcomes among Chinese middle-aged and older adults. Actions should be taken to prevent and treat hearing impairment, so as to improve people's health and well-being.",2020,"As the severity of hearing impairment increased, individuals were likely to have impaired ADLs, impaired IADLs and depressive symptoms.
","['Chinese middle-aged and older adults', 'participants aged 45\u2009years old had hearing problems; and (2) Hearing Survey 2019, the baseline survey of a randomized controlled trial conducted in Shandong Province of China, including 376 middle-aged and older participants']",[],"['chronic diseases, impaired activities of daily living (ADLs), impaired instrumental activities of daily living (IADLs) and depressive symptoms', 'severity of hearing impairment']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}]",[],"[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",,0.0716996,"As the severity of hearing impairment increased, individuals were likely to have impaired ADLs, impaired IADLs and depressive symptoms.
","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'School of Public Health, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'China Center for Health Development Studies, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'China Center for Health Development Studies, Peking University, 38 Xue Yuan Road, Haidian District, Beijing, 100191, China. phe@pku.edu.cn.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01417-w']
3015,32460882,Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes.,"BACKGROUND


Using a real dataset, we highlighted several major methodological issues raised by the estimation of the Minimal Clinically Important Difference (MCID) of a Patient-Reported Outcomes instrument. We especially considered the management of missing data and the use of more than two times of measurement. While inappropriate missing data management and inappropriate use of multiple time points can lead to loss of precision and/or bias in MCID estimation, these issues are almost never dealt with and require cautious considerations in the context of MCID estimation.
METHODS


We used the LIGALONGO study (French Randomized Controlled Trial). We estimated MCID on the SF-36 General Health score by comparing many methods (distribution or anchor-based). Different techniques for imputation of missing data were performed (simple and multiple imputations). We also consider all measurement occasions by longitudinal modeling, and the dependence of the score difference on baseline.
RESULTS


Three hundred ninety-three patients were studied. With distribution-based methods, a great variability in MCID was observed (from 3 to 26 points for improvement). Only 0.2 SD and 1/3 SD distribution methods gave MCID values consistent with anchor-based methods (from 4 to 7 points for improvement). The choice of missing data imputation technique clearly had an impact on MCID estimates. Simple imputation by mean score seemed to lead to out-of-range estimate, but as missing not at random mechanism can be hypothesized, even multiple imputations techniques can have led to an slight underestimation of MCID. Using 3 measurement occasions for improvement led to an increase in precision but lowered estimates.
CONCLUSION


This practical example illustrates the substantial impact of some methodological issues that are usually never dealt with for MCID estimation. Simulation studies are needed to investigate those issues.
TRIAL REGISTRATION


NCT01240772 (ClinicalTrials.gov) registered on November 15, 2010.",2020,"With distribution-based methods, a great variability in MCID was observed (from 3 to 26 points for improvement).",['Three hundred ninety-three patients were studied'],[],"['precision', 'SF-36 General Health score']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",393.0,0.117153,"With distribution-based methods, a great variability in MCID was observed (from 3 to 26 points for improvement).","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Woaye-Hune', 'Affiliation': 'Inserm, Université Bretagne-Loire - Université de Nantes - Université de Tours, UMR U1246 SPHERE ""Methods in patient-centered outcomes and health research"", Nantes, France.'}, {'ForeName': 'Jean-Benoit', 'Initials': 'JB', 'LastName': 'Hardouin', 'Affiliation': 'Inserm, Université Bretagne-Loire - Université de Nantes - Université de Tours, UMR U1246 SPHERE ""Methods in patient-centered outcomes and health research"", Nantes, France.'}, {'ForeName': 'Paul-Antoine', 'Initials': 'PA', 'LastName': 'Lehur', 'Affiliation': 'Digestive Surgery Department, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Meurette', 'Affiliation': 'Digestive Surgery Department, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Vanier', 'Affiliation': 'Inserm, Université Bretagne-Loire - Université de Nantes - Université de Tours, UMR U1246 SPHERE ""Methods in patient-centered outcomes and health research"", Nantes, France. antoine.vanier@univ-nantes.fr.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01398-w']
3016,32976085,High-flow nasal oxygen reduces endotracheal intubation: a randomized clinical trial.,"BACKGROUND


The benefits of high-flow nasal cannula (HFNC) as primary intervention in patients with acute hypoxemic respiratory failure (AHRF) are still a matter in debate. Our objective was to compare HFNC therapy  versus  conventional oxygen therapy (COT) in the prevention of endotracheal intubation in this group of patients.
METHODS


An open-label, controlled and single-centre clinical trial was conducted in patients with severe AHRF, defined by a PaO 2 /FIO 2  ratio ⩽200, to compare HFNC with a control group (CG) treated by COT delivered through a face mask, with the need to perform intubation as the primary outcome. The secondary outcomes included tolerance of the HFNC device and to look for the predictive factors for intubation in these patients.
RESULTS


A total of 46 patients were included (22 in the COT group and 24 in the HFNC group) 48% of whom needed intubation: 63% in the COT group and 33% in the HFNC group, with significant differences both in intention to treat [χ 2  = 4.2;  p  = 0.04, relative risk (RR) = 0.5; confidence interval (CI) 95%: 0.3-1.0] and also in treatment analysis (χ 2  = 4.7;  p  = 0.03; RR = 0.5; IC 95%: 0.3-0.9) We obtained a number needed to treat (NNT) = 3 patients treated to avoid an intubation. Intubation occurred significantly later in the HFNC group. Estimated PaO 2 /FIO 2 , respiratory rate and dyspnea were significantly better in the HFNC group. Patients treated with HFNC who required intubation presented significant worsening after the first 8 h, as compared with non-intubated HFNC group patients. Mortality was 22% with no differences. The HFNC group patients were hospitalized for almost half of the time in the intensive care unit (ICU) and in the ward, with significantly less hospital length of stay. A total of 14 patients in the HFNC group (58%) complained of excessive heat and 17% of noise; 3 patients did not tolerate HFNC.
CONCLUSION


Patients with severe acute hypoxemic respiratory failure who tolerate HFNC present a significantly lower need for endotracheal intubation compared with conventional oxygen therapy.
CLINICAL TRIAL REGISTER


EUDRA CT number: 2012-001671-36 The reviews of this paper are available via the supplemental material section.",2020,"Patients treated with HFNC who required intubation presented significant worsening after the first 8 h, as compared with non-intubated HFNC group patients.","['patients with severe AHRF, defined by a PaO 2 /FIO 2  ratio ⩽200, to compare HFNC with a control group (CG) treated by', '14 patients in the HFNC group (58', 'patients with acute hypoxemic respiratory failure (AHRF', 'Patients with severe acute hypoxemic respiratory failure']","['COT', 'High-flow nasal oxygen reduces endotracheal intubation', 'conventional oxygen therapy', 'HFNC therapy  versus  conventional oxygen therapy (COT', 'HFNC', 'high-flow nasal cannula (HFNC']","['Mortality', 'complained of excessive heat', 'Estimated PaO 2 /FIO 2 , respiratory rate and dyspnea', 'endotracheal intubation', 'hospital length of stay', 'Intubation', 'tolerance of the HFNC device and to look for the predictive factors for intubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0183644', 'cui_str': 'Trolley'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",46.0,0.295594,"Patients treated with HFNC who required intubation presented significant worsening after the first 8 h, as compared with non-intubated HFNC group patients.","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Andino', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Diego de León 62, Madrid, 28006, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Vega', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Sandra Karina', 'Initials': 'SK', 'LastName': 'Pacheco', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Arevalillo', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Leal', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fernández', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Rodriguez', 'Affiliation': 'Intensive Care Unit, University Hospital La Princesa, Madrid, Spain.'}]",Therapeutic advances in respiratory disease,['10.1177/1753466620956459']
3017,32976120,Three-Dimensional-Printed Liver Model Helps Learners Identify Hepatic Subsegments: A Randomized-Controlled Cross-Over Trial.,"INTRODUCTION


The purpose of this study was to find out whether 3-dimensional (3D)-printed models improved the learners' ability to identify liver segments.
METHODS


A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images. Adjusted multilevel-mixed models were used to compare scores at baseline and after 3D and 2D.
RESULTS


Accuracy in identifying hepatic segments was higher with 3D first than 2D (77% vs 69%; P = 0.05) and not significantly improved by a combination of 3D and 2D. Increased confidence in segment identification was highest in trainees after 3D (P = 0.04).
DISCUSSION


3D-printed models facilitate learning hepatic segmental anatomy.",2020,A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images.,['A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images'],[],['confidence in segment identification'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}]",116.0,0.0489261,A total of 116 physicians from 3 disciplines were tested in a cross-over trial at baseline and after teaching with 3D models and 2-dimensional (2D) images.,"[{'ForeName': 'Victor G', 'Initials': 'VG', 'LastName': 'Chedid', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Amika A', 'Initials': 'AA', 'LastName': 'Kamath', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'M Knudsen', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Frimannsdottir', 'Affiliation': 'Mayo Clinic Center for Clinical and Translational Science, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Yost', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'R Geske', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Morris', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Timucin', 'Initials': 'T', 'LastName': 'Taner', 'Affiliation': 'Division of Transplantation Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Kamath', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000958']
3018,32976172,Efficacy and Safety of 2 Injection Techniques for Hand Biostimulatory Treatment With Diluted Calcium Hydroxylapatite.,"BACKGROUND


Calcium hydroxylapatite (CaHA) is effective for dorsal hand rejuvenation. Higher dilutions are used for biostimulation with fewer side effects.
OBJECTIVE


To evaluate the efficacy and safety of 2 techniques of diluted CaHA injection for dorsal hand treatment.
METHODS


A prospective, evaluator-blinded study was performed to compare (side-to-side) techniques for treating the dorsum of the hands with diluted CaHA: deep fat lamina or subdermal injection. Fifteen women with aging grades between 1 and 3 on the MHGS (Merz hand grading scale) were enrolled and followed up for 24 weeks. The outcomes were a histological analysis of collagen, skin viscoelasticity, high-frequency ultrasound parameters, MHGS score, and the global aesthetic improvement scale (GAIS) score.
RESULTS


Improvement in the MHGS and GAIS scores (p < .01) was observed, with no difference between techniques (p > .05). Skin viscoelasticity measures and ultrasonography for dermal parameters improved for both treatments (p < .01). The mean total collagen density increased from the baseline for both techniques (p < .01). Pain during the procedure as well as adverse effects within the follow-up did not differ between treatments (p > .4). The overall satisfaction was 12% greater for the subdermal technique (p < .05).
CONCLUSION


Diluted CaHA improves the skin quality of aging hands with a safe profile, without substantial differences between the techniques.",2020,Pain during the procedure as well as adverse effects within the follow-up did not differ between treatments (p > .4).,['Fifteen women with aging grades between 1 and 3 on the MHGS (Merz hand grading scale) were enrolled and followed up for 24 weeks'],"['Calcium hydroxylapatite (CaHA', 'Diluted Calcium Hydroxylapatite', 'diluted CaHA injection', 'Diluted CaHA']","['MHGS and GAIS scores', 'mean total collagen density', 'histological analysis of collagen, skin viscoelasticity, high-frequency ultrasound parameters, MHGS score, and the global aesthetic improvement scale (GAIS) score', 'efficacy and safety', 'overall satisfaction', 'Efficacy and Safety', 'Skin viscoelasticity measures and ultrasonography for dermal parameters', 'adverse effects', 'Pain', 'skin quality']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",15.0,0.0306283,Pain during the procedure as well as adverse effects within the follow-up did not differ between treatments (p > .4).,"[{'ForeName': 'Vinícius O', 'Initials': 'VO', 'LastName': 'Figueredo', 'Affiliation': 'Collaborator at Departamento de Dermatologia, Escola Paulista de Medicina, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Hélio A', 'Initials': 'HA', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, FMB-Unesp, Botucatu, SP, Brazil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Soares Dias', 'Affiliation': 'Collaborator at Departamento de Dermatologia, Escola Paulista de Medicina, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Gisele Jacobino de Barros', 'Initials': 'GJB', 'LastName': 'Nunes', 'Affiliation': 'Collaborator at Departamento de Dermatologia, Escola Paulista de Medicina, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Barros de Souza', 'Affiliation': 'Collaborator at Departamento de Dermatologia, Escola Paulista de Medicina, UNIFESP, São Paulo, SP, Brazil.'}, {'ForeName': 'Ediléia', 'Initials': 'E', 'LastName': 'Bagatin', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, FMB-Unesp, Botucatu, SP, Brazil.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002334']
3019,32976204,Effect of two different pre-operative exercise training regimens before colorectal surgery on functional capacity: A randomised controlled trial.,"BACKGROUND


Multimodal prehabilitation, including exercise training, nutritional therapy and anxiety reduction, has been shown to attenuate functional decline associated with surgery. Due to the growing interest in functional status as a targeted surgical outcome, a better understanding of the optimal prescription of exercise is critical.
OBJECTIVE


The objective is to compare peri-operative functional trajectory in response to two different exercise training protocols within a 4-week, supervised, multimodal prehabilitation programme.
DESIGN


This was a single blinded, single centre, randomised controlled study. Participants performed four assessments: at baseline, after prehabilitation (just before surgery), and at 1 and 2 months after surgery.
PATIENTS


Adult patients scheduled for elective resection of nonmetastatic colorectal cancer were included provided there were no absolute contraindications to exercise nor poor language comprehension.
INTERVENTION


Patients followed either high-intensity interval training (HIIT), or moderate intensity continuous training (MICT), as part of a 4-week multimodal prehabilitation programme. Both groups followed the same supervised resistance training, nutritional therapy and anxiety reduction interventions. All patients followed standardised peri-operative management.
MAIN OUTCOME MEASURE


Changes in oxygen consumption at anaerobic threshold, measured with sequential cardio-pulmonary exercise testing, were assessed and compared between groups.
RESULTS


Forty two patients were included in the primary analysis (HIIT n = 21 vs. MICT n = 21), with mean ± SD age 64.5 ± 11.2 years and 62% were men. At 2 months after surgery, 13/21 (62%) in HIIT and 11/21 (52%) in MICT attended the study visits. Both protocols significantly enhanced pre-operative functional capacity, with no difference between groups: mean (95% confidence interval) oxygen consumption at anaerobic threshold 1.97 (0.75 to 3.19) ml kg min in HIIT vs. 1.71 (0.56 to 2.85) in MICT, P = 0.753. At 2 months after surgery, the HIIT group showed a higher improvement in physical fitness: 2.36 (0.378 to 4.34) ml kg min, P = 0.021. No adverse events occurred during the intervention.
CONCLUSION


Both MICT and HIIT enhanced pre-operative functional capacity.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03361150.",2020,"At 2 months after surgery, the HIIT group showed a higher improvement in physical fitness: 2.36 (0.378 to 4.34) ","['Adult patients scheduled for elective resection of nonmetastatic colorectal cancer', 'Forty', 'two patients were included in the primary analysis (HIIT n\u200a=\u200a21 vs. MICT n\u200a=\u200a21), with mean\u200a±\u200aSD age 64.5\u200a±\u200a11.2 years and 62% were men']","['Patients followed either high-intensity interval training (HIIT), or moderate intensity continuous training (MICT', 'pre-operative exercise training regimens', 'supervised resistance training, nutritional therapy and anxiety reduction interventions']","['adverse events', 'oxygen consumption', 'physical fitness', 'pre-operative functional capacity', 'Changes in oxygen consumption at anaerobic threshold, measured with sequential cardio-pulmonary exercise testing', 'functional capacity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",42.0,0.0783114,"At 2 months after surgery, the HIIT group showed a higher improvement in physical fitness: 2.36 (0.378 to 4.34) ","[{'ForeName': 'Enrico M', 'Initials': 'EM', 'LastName': 'Minnella', 'Affiliation': 'From the Department of Anesthesia, McGill University Health Centre, Montreal General Hospital, (EMM, VF, RA, CS-B, FC), Department of Kinesiology and Physical Education, McGill University, (VF, CS-B), Department of Surgery, (PC, BS, ASL) and Division of Geriatric Medicine, McGill University Health Centre, Montreal General Hospital, Montreal, Quebec, Canada (JAM).'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Ferreira', 'Affiliation': ''}, {'ForeName': 'Rashami', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Charlebois', 'Affiliation': ''}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Liberman', 'Affiliation': ''}, {'ForeName': 'Celena', 'Initials': 'C', 'LastName': 'Scheede-Bergdahl', 'Affiliation': ''}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Morais', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001215']
3020,32974775,Coronally advanced flap achieved higher esthetic outcomes without a connective tissue graft for the treatment of single gingival recessions: a 4-year randomized clinical trial.,"OBJECTIVES


Limited long-term data are available when comparing the esthetic outcomes of coronally advanced flap (CAF) with or without a connective tissue graft (CTG). The aim of this study was to compare the 4-year esthetic outcomes of CAF vs CAF + CTG for the treatment of isolated maxillary gingival recessions.
MATERIAL AND METHODS


Forty-eight patients were randomly assigned for treatment either with CAF (control; N = 24) or to CAF + CTG (test group; N = 24). Patients were followed after the surgery until the final evaluation. A professional esthetic evaluation was performed using the Root coverage Esthetic Score (RES). Recession reduction, mean root coverage, and complete root coverage were also evaluated.
RESULTS


Forty-two patients completed the study at the 4-year recall. A significant recession reduction was evident at 4 years, without significant intergroup differences. The CAF group showed a statistically significant higher final RES compared with the CAF + CTG group (9.14 ± 1.08 vs 7.25 ± 1.29, respectively, p < 0.001). Regarding the individual components of RES, gingival margin and marginal tissue contour were significantly higher in the CAF group compared with that in the CAF + CTG group.
CONCLUSIONS


CAF presented with a significantly higher overall esthetic score than CAF + CTG, and in the individual RES components of marginal tissue contour and gingival margin after 4 years.
CLINICAL RELEVANCE


CAF without the addition of CTG provided higher esthetic outcomes for the treatment of isolated gingival recessions.",2020,"Regarding the individual components of RES, gingival margin and marginal tissue contour were significantly higher in the CAF group compared with that in the CAF + CTG group.
","['isolated maxillary gingival recessions', 'Forty-two patients completed the study at the 4-year recall', 'Forty-eight patients']","['CAF + CTG', 'CAF (control; N = 24) or to CAF + CTG', 'CAF vs CAF + CTG', 'connective tissue graft', 'coronally advanced flap (CAF) with or without a connective tissue graft (CTG', 'Coronally advanced flap', 'CTG', 'CAF']","['overall esthetic score', 'Root coverage Esthetic Score (RES', 'recession reduction', '4-year esthetic outcomes', 'final RES', 'esthetic outcomes', 'RES, gingival margin and marginal tissue contour', 'Recession reduction, mean root coverage, and complete root coverage']","[{'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C4319608', 'cui_str': '48'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",48.0,0.0500367,"Regarding the individual components of RES, gingival margin and marginal tissue contour were significantly higher in the CAF group compared with that in the CAF + CTG group.
","[{'ForeName': 'Stephany', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Department of Periodontology, School of Dentistry, Universidad Científica del Sur, Calle Cantuarias 398, Miraflores, 15074, Lima, Peru.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'de la Rosa', 'Affiliation': 'Department of Periodontics, AME University Monterrey, Monterrey, Mexico.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Mancini', 'Affiliation': 'Private Practice, Rosario, Argentina.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dias', 'Affiliation': 'Department of Periodontology, School of Dentistry, Universidad Científica del Sur, Calle Cantuarias 398, Miraflores, 15074, Lima, Peru.'}, {'ForeName': 'Shayan', 'Initials': 'S', 'LastName': 'Barootchi', 'Affiliation': 'Department of Periodontics & Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Tavelli', 'Affiliation': 'Department of Periodontics & Oral Medicine, University of Michigan School of Dentistry, Ann Arbor, MI, USA.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Mendoza-Azpur', 'Affiliation': 'Department of Periodontology, School of Dentistry, Universidad Científica del Sur, Calle Cantuarias 398, Miraflores, 15074, Lima, Peru. gmendoza@ucientifica.edu.pe.'}]",Clinical oral investigations,['10.1007/s00784-020-03587-9']
3021,32974802,"Effect of rowing on mobility, functionality, and quality of life in women with and without breast cancer: a 4-month intervention.","PURPOSE


Of the different modalities of rowing, dragon boat training is the most analyzed in breast cancer (BC). However, other types of boats, such as the felucca, use different biomechanical techniques, which have not been studied in the scientific literature. Consequently, in this study, we sought to determine the benefits of felucca rowing on the physical, psychological, and emotional well-being of patients with BC and healthy persons.
METHODS


A pre- and post-intervention, single-arm study without a control group with a 4-month intervention was carried out in Spain in 2019. The study sample included six women with BC and 15 healthy women. The following questionnaires were administered before and after the intervention: Disabilities of the Arm, Shoulder, and Hand (DASH), Constant-Murley score (CMS), and the European Quality of Life 5 Dimensions (EQ-5D, rate your health today). Differences were determined before and after the intervention using the paired t test.
RESULTS


Significant differences (p < 0.05) were found in the results of all the questionnaires for the women with BC and for the healthy women: DASH (- 13.8 BC and - 6.7 healthy), CMS (+ 12.0 BC and 9.2 healthy), and EQ-5D (+ 8.5 BC and 10.5 healthy).
CONCLUSION


Felucca rowing showed benefits in health and quality of life in both women with BC and healthy women. In future studies with controlled design, values regarding clinical relevance, such as effect sizes/confidence intervals, are needed to corroborate our results.",2020,"RESULTS


Significant differences (p < 0.05) were found in the results of all the questionnaires for the women with BC and for the healthy women: DASH (- 13.8 BC and - 6.7 healthy), CMS (+ 12.0 BC and 9.2 healthy), and EQ-5D (+ 8.5 BC and 10.5 healthy).
","['women with and without breast cancer', 'six women with BC and 15 healthy women', 'women with BC and healthy women', 'breast cancer (BC', 'patients with BC and healthy persons']","['felucca rowing', 'Felucca rowing', 'rowing, dragon boat training']","['mobility, functionality, and quality of life', 'health and quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C4553584', 'cui_str': 'Dragon'}, {'cui': 'C0085910', 'cui_str': 'Boat'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",6.0,0.0414018,"RESULTS


Significant differences (p < 0.05) were found in the results of all the questionnaires for the women with BC and for the healthy women: DASH (- 13.8 BC and - 6.7 healthy), CMS (+ 12.0 BC and 9.2 healthy), and EQ-5D (+ 8.5 BC and 10.5 healthy).
","[{'ForeName': 'María Del Rosario', 'Initials': 'MDR', 'LastName': 'Asensio-García', 'Affiliation': 'Rehabilitation Service, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Tomás-Rodríguez', 'Affiliation': 'Center for Translational Research in Physiotherapy, Department of Pathology and Surgery, Miguel Hernández University, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palazón-Bru', 'Affiliation': 'Department of Clinical Medicine, Miguel Hernández University, Ctra. Valencia-Alicante S/N, San Juan de Alicante, 03550, Alicante, Spain. antonio.pb23@gmail.com.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Hernández-Sánchez', 'Affiliation': 'Center for Translational Research in Physiotherapy, Department of Pathology and Surgery, Miguel Hernández University, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'Rauf', 'Initials': 'R', 'LastName': 'Nouni-García', 'Affiliation': 'Rehabilitation Service, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'Aída Lucía', 'Initials': 'AL', 'LastName': 'Romero-Aledo', 'Affiliation': 'Rehabilitation Service, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain.'}, {'ForeName': 'Vicente Francisco', 'Initials': 'VF', 'LastName': 'Gil-Guillén', 'Affiliation': 'Department of Clinical Medicine, Miguel Hernández University, Ctra. Valencia-Alicante S/N, San Juan de Alicante, 03550, Alicante, Spain.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05757-7']
3022,32974815,The effect of a mystery shopper scheme on prescribing behavior in primary care: Results from a field experiment.,"BACKGROUND


Health care systems in many countries are characterized by limited availability of provider performance data that can be used to design and implement welfare improving reforms in the health sector. We question whether a simple mystery shopper scheme can be an effective measure to improve primary care quality in such settings.
METHODS


Using a randomized treatment-control design, we conducted a field experiment in primary care clinics in a Chinese city. We investigate whether informing physicians of a forthcoming mystery shopper audit influences their prescribing behavior. The intervention effects are estimated using conditional fixed-effects logistic regression. The estimated coefficients are interpreted as marginal utilities in a choice model.
RESULTS


Our findings suggest that the mystery shopper intervention reduced the probability of prescribing overall. Moreover, the intervention had heterogeneous effects on different types of drugs.
CONCLUSIONS


This study provides new evidence suggesting that announced performance auditing of primary care providers could directly affect physician behavior even when it is not combined with pay-for-performance, or measures such as reminders, feedback or educational interventions.",2020,"We question whether a simple mystery shopper scheme can be an effective measure to improve primary care quality in such settings.
","['primary care', 'primary care clinics in a Chinese city']",['mystery shopper scheme'],['probability of prescribing overall'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0506524,"We question whether a simple mystery shopper scheme can be an effective measure to improve primary care quality in such settings.
","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Cheo', 'Affiliation': 'Center for Economic Research, Shandong University, 27 Shanda Nanlu, Jinan, Shandong, 250100, P.R., China.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Ge', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, P.O. Box 1089 Blindern, Oslo, 0317, Norway.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Godager', 'Affiliation': 'Department of Health Management and Health Economics, University of Oslo, P.O. Box 1089 Blindern, Oslo, 0317, Norway.'}, {'ForeName': 'Rugang', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'School of Health Policy & Management, Nanjing Medical University, 101 Longmian Avenue, Jiangning District, Nanjing, 211166, P.R., China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Dong Fureng Institute of Economic and Social Development, Wuhan University, 54 Lishi Hutong, Dongcheng District, Beijing, 100010, China.'}, {'ForeName': 'Qiqi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""School of Economics, Xi'an University of Finance and Economics, 360 Changning Avenue, Chang'an District, Xi'an Shanxi, 710100, China.""}]",Health economics review,['10.1186/s13561-020-00290-z']
3023,32974838,"Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A.","An open-label, crossover randomized study was performed to compare the pharmacokinetics (PK) of damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII (FVIII) products indicated in patients with hemophilia A, both conjugated to polyethylene glycol to reduce clearance and extend time in circulation. Adult patients (N = 18) with severe hemophilia A (FVIII < 1 IU/dL), previously treated with any FVIII product for ≥ 150 exposure days, were randomized to receive a single 50 IU/kg infusion of damoctocog alfa pegol followed by rurioctocog alfa pegol, or vice versa, with ≥ 7-day washout between doses. FVIII activity was measured using the one-stage clotting assay. PK parameters, including area under the curve from time 0 to the last data point (AUC 0-tlast , primary parameter), dose-normalized AUC (AUC norm ), and time to threshold, were calculated based on 11 time points between 0.25 and 120 h post-dose and evaluated using a noncompartmental model. Due to differences in batch-specific vial content used for the study, actual administered median doses were 54.3 IU/kg for damoctocog alfa pegol and 61.4 IU/kg for rurioctocog alfa pegol. Based on actual dosing, a significantly higher geometric mean (coefficient of variation [%CV]) AUC norm  was observed for damoctocog alfa pegol (43.8 h kg/dL [44.0]) versus rurioctocog alfa pegol (36.0 h kg/dL [40.1, P < 0.001]). Based on population PK modeling, median time to reach 1 IU/dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol. No adverse events or any immunogenicity signals were observed. Overall, damoctocog alfa pegol had a superior PK profile versus rurioctocog alfa pegol. Trial registration number: NCT04015492 ( ClinicalTrials.gov identifier). Date of registration: July 9, 2019.",2020,dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol.,"['Adult patients (N = 18) with severe hemophilia A', 'patients with severe hemophilia A', 'patients with hemophilia A']","['damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII ', 'two extended half-life PEGylated recombinant FVIII products']","['geometric mean (coefficient of variation [%CV', 'FVIII activity', 'PK parameters, including area under the curve from time 0 to the last data point (AUC 0-tlast , primary parameter), dose-normalized AUC (AUC norm ), and time to threshold']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}]","[{'cui': 'C4723219', 'cui_str': 'damoctocog alfa pegol'}, {'cui': 'C0795577', 'cui_str': 'recombinant antihemophilic factor VIII'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",18.0,0.109307,dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Solms', 'Affiliation': 'Clinical Pharmacometrics, Pharmaceuticals Research & Development, Bayer AG, 13353, Berlin, Germany. alexander.solms@bayer.com.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Bayer, Whippany, NJ, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Berntorp', 'Affiliation': 'Centre for Thrombosis and Haemostasis, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Tiede', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Iorio', 'Affiliation': 'McMaster-Bayer Endowed Research Chair in Clinical Epidemiology of Congenital Bleeding Disorders, Department of Medicine, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Linardi', 'Affiliation': 'Bayer, Whippany, NJ, USA.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Ahsman', 'Affiliation': 'LAP&P Consultants BV, Leiden, the Netherlands.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Mancuso', 'Affiliation': 'Center for Thrombosis and Hemorrhagic Diseases, Humanitas Clinical and Research Center - IRCCS, Rozzano, Milan, Italy.'}, {'ForeName': 'Tihomir', 'Initials': 'T', 'LastName': 'Zhivkov', 'Affiliation': 'Specialized Hospital for Active Treatment, Sofia, Bulgaria.'}, {'ForeName': 'Toshko', 'Initials': 'T', 'LastName': 'Lissitchkov', 'Affiliation': 'Specialized Hospital for Active Treatment, Sofia, Bulgaria.'}]",Annals of hematology,['10.1007/s00277-020-04280-3']
3024,30955043,Improvement of Working Memory is a Mechanism for Reductions in Delay Discounting Among Mid-Age Individuals in an Urban Medically Underserved Area.,"BACKGROUND


Delay discounting, or the tendency to devalue rewards as a function of their delayed receipt, is associated with myriad negative health behaviors. Individuals from medically underserved areas are disproportionately at risk for chronic health problems. The higher rates of delay discounting and consequent adverse outcomes evidenced among low-resource and unstable environments suggest this may be an important pathway to explain health disparities among this population.
PURPOSE


The current study examined the effectiveness of a computerized working memory training program to decrease rates of delay discounting among residents of a traditionally underserved region.
METHODS


Participants (N = 123) were recruited from a community center serving low income and homeless individuals. Subjects completed measures of delay discounting and working memory and then took part in either an active or control working memory training.
RESULTS


Analyses indicated that participants in the active condition demonstrated significant improvement in working memory and that this improvement mediated the relation between treatment condition and reductions in delay discounting.
CONCLUSIONS


Results suggest that a computerized intervention targeting working memory may be effective in decreasing rates of delay discounting in adults from medically underserved areas (ClinicalTrials.gov number NCT03501706).",2019,"Subjects completed measures of delay discounting and working memory and then took part in either an active or control working memory training.
","['Participants (N = 123) were recruited from a community center serving low income and homeless individuals', 'residents of a traditionally underserved region', 'Mid-Age Individuals in an Urban Medically Underserved Area']","['computerized working memory training program', 'active or control working memory training']","['delay discounting and working memory', 'rates of delay discounting', 'working memory', 'delay discounting']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",123.0,0.0429412,"Subjects completed measures of delay discounting and working memory and then took part in either an active or control working memory training.
","[{'ForeName': 'Julia W', 'Initials': 'JW', 'LastName': 'Felton', 'Affiliation': 'Division of Public Health, Michigan State University, Flint, MI, USA.'}, {'ForeName': 'Anahi', 'Initials': 'A', 'LastName': 'Collado', 'Affiliation': 'Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Ingram', 'Affiliation': 'Department of Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Doran', 'Affiliation': 'School of Nursing, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Yi', 'Affiliation': 'Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, KS, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz010']
3025,31119610,"Finding Common Ground: Can Provider-Patient Race Concordance and Self-disclosure Bolster Patient Trust, Perceptions, and Intentions?","BACKGROUND


Improvements in provider-patient relationships may help alleviate health disparities. Provider-patient race concordance and provider self-disclosure are variables that may help improve this relationship.
PURPOSE


This study sought to answer if provider-patient race concordance and provider self-disclosure may improve patient trust, rapport, similarity, likeability, intention to disclose, satisfaction, behavioral intention to keep a provider, and intention to recommend a provider, while using empathy as a covariate.
METHODS


Using 882 White or Black participants, the current research used a 2 × 2 online experimental design. Participants were asked to read a vignette in which they were told they had borderline high cholesterol and needed to eat a healthier diet, by either a Black or White male physician, who either self-disclosed or did not self-disclose regarding their own struggle to eat a healthy diet. After reading this vignette, participants were surveyed regarding the dependent variables of interest.
RESULTS


Participants in a Black concordant dyad reported higher levels of similarity than those in any other dyad. Provider self-disclosure led to higher levels of trust, rapport, similarity, likeability, intention to disclose, satisfaction, behavioral intention to continue using the provider, and intention to recommend the provider. No interaction effects were found.
CONCLUSION


While it is possible, based on past research, that race-concordant pairings may lead to trust via similarity, provider self-disclosure directly increased perceptions of trust as well as providing numerous other benefits. This study supports the importance of trainings for providers on health-related self-disclosure to benefit both parties in provider-patient dyads.",2019,"Provider self-disclosure led to higher levels of trust, rapport, similarity, likeability, intention to disclose, satisfaction, behavioral intention to continue using the provider, and intention to recommend the provider.","['Using 882 White or Black participants', 'Participants were asked to read a vignette in which they were told they had borderline high cholesterol and needed to eat a healthier diet, by either a Black or White male physician, who either']",['self-disclosed or did not self-disclose regarding their own struggle to eat a healthy diet'],"['levels of trust, rapport, similarity, likeability, intention to disclose, satisfaction, behavioral intention']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C2711208', 'cui_str': 'Borderline high'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0480642,"Provider self-disclosure led to higher levels of trust, rapport, similarity, likeability, intention to disclose, satisfaction, behavioral intention to continue using the provider, and intention to recommend the provider.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Nazione', 'Affiliation': 'Communication Department, Berry College, Box 299 Berry College, Mount Berry, GA, 30149, USA. snazione@berry.edu.'}, {'ForeName': 'Evan K', 'Initials': 'EK', 'LastName': 'Perrault', 'Affiliation': 'Brian Lamb School of Communication, Purdue University, 100 N. University Street, West Lafayette, IN, 47907, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Keating', 'Affiliation': 'California State University, Northridge, Communication Studies, MZ 351, 18111 Nordhoff Street, Northridge, CA, 91330, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-019-00597-6']
3026,31325474,Food has the right of way: Evidence for prioritised processing of visual food stimuli irrespective of eating style.,"Visual attention for food is likely to play an important role for overeating. The attentional bias for visual food stimuli was investigated with respect to self-reported restrained, external and emotional eating style. Using a Rapid Serial Visual Presentation task (N = 103), the effects of visual food stimuli in the context of the attentional blink were examined. Food targets enhanced the attentional blink when presented as first targets in a rapid stream of pictures and impaired the identification of preceding non-food targets in terms of a backward interference when presented as second targets. Task irrelevant food distractors interfered with the identification of subsequent non-food targets. The effects provide evidence for a prioritisation of food stimuli in the allocation of attentional resources. The attentional bias for food emerged as a universal phenomenon irrespective of personal eating style. Therefore, enhanced attention for visual food stimuli seems to play no direct causal role in eating styles associated with overeating.",2019,"The attentional bias for visual food stimuli was investigated with respect to self-reported restrained, external and emotional eating style.",[],[],['attentional blink'],[],[],"[{'cui': 'C1955945', 'cui_str': 'Attentional Blink'}]",,0.0464754,"The attentional bias for visual food stimuli was investigated with respect to self-reported restrained, external and emotional eating style.","[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Kirsten', 'Affiliation': 'Department of Psychology, University of Bonn, Kaiser-Karl-Ring 9, 53111, Bonn, Germany. Electronic address: hkirsten@uni-bonn.de.'}, {'ForeName': 'Laura-Effi', 'Initials': 'LE', 'LastName': 'Seib-Pfeifer', 'Affiliation': 'Department of Psychology, University of Bonn, Kaiser-Karl-Ring 9, 53111, Bonn, Germany. Electronic address: l.seib-pfeifer@uni-bonn.de.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Koppehele-Gossel', 'Affiliation': 'Department of Psychology, University of Bonn, Kaiser-Karl-Ring 9, 53111, Bonn, Germany. Electronic address: j.koppehele@uni-bonn.de.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Gibbons', 'Affiliation': 'Department of Psychology, University of Bonn, Kaiser-Karl-Ring 9, 53111, Bonn, Germany. Electronic address: hgibbons@uni-bonn.de.'}]",Appetite,['10.1016/j.appet.2019.104372']
3027,31326438,Hunger promotes the detection of high-fat food.,"Efficient detection of food is important for an organism's survival. The results of previous experimental studies are consistent with this statement: food is detected in photographs faster than non-food items. Moreover, fat content modulates the speed of food detection. However, it is not known whether such sensitivity to the fat content of food is modulated by participants' internal states. To investigate these issues, we measured reaction times during a visual search task in which participants in fasting and postprandial states detected high-fat food (fast food), low-fat food (Japanese diet), and non-food (kitchen utensils) targets within crowds of non-food distractors (cars). Our results indicate that both hungry and satiated groups detected food targets more rapidly than non-food targets. The high-fat foods were detected more rapidly than low-fat foods in the hungry group, whereas no difference was observed between reaction times when satiated participants detected high-fat and low-fat food targets. These results suggest that food captures our visual attention even when we are satiated, and that fat detection efficiency is heightened when we are hungry.",2019,"The high-fat foods were detected more rapidly than low-fat foods in the hungry group, whereas no difference was observed between reaction times when satiated participants detected high-fat and low-fat food targets.","['participants in fasting and postprandial states detected high-fat food (fast food), low-fat food (Japanese diet), and non-food (kitchen utensils) targets within crowds of non-food distractors (cars']",[],['high-fat foods'],"[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0453819', 'cui_str': 'Fatty food'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0453839', 'cui_str': 'Low fat food'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0557653', 'cui_str': 'Kitchen'}, {'cui': 'C0010383', 'cui_str': 'Crowding'}]",[],"[{'cui': 'C0453819', 'cui_str': 'Fatty food'}]",,0.0224453,"The high-fat foods were detected more rapidly than low-fat foods in the hungry group, whereas no difference was observed between reaction times when satiated participants detected high-fat and low-fat food targets.","[{'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Sawada', 'Affiliation': 'Graduate School of Medicine, Kyoto University, 53 Shogoin Kawahara-cho, Sakyo, Kyoto, 606-8507, Japan; Organization for Promoting Neurodevelopmental Disorder Research, 40 Shogoin Sanno-cho, Sakyo-ku, Kyoto, 606-8392, Japan. Electronic address: sawada.reiko.3z@kyoto-u.ac.jp.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Sato', 'Affiliation': 'Kokoro Research Center, Kyoto University, 46 Shimoadachi-cho, Sakyo-ku, Kyoto, 606-8501, Japan. Electronic address: sato.wataru.4v@kyoto-u.ac.jp.'}, {'ForeName': 'Kazusa', 'Initials': 'K', 'LastName': 'Minemoto', 'Affiliation': 'Kokoro Research Center, Kyoto University, 46 Shimoadachi-cho, Sakyo-ku, Kyoto, 606-8501, Japan.'}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Fushiki', 'Affiliation': 'Faculty of Agriculture, Ryukoku University, 1-5 Yokotani, Seta Oe-cho, Otsu, Shiga, 520-2194, Japan.'}]",Appetite,['10.1016/j.appet.2019.104377']
3028,31326440,Colouring perception: Package colour cues affect neural responses to sweet dairy drinks in reward and inhibition related regions.,"Extrinsic product cues such as package colour may change product perception and perceived reward value during product evaluation. Healthier foods (i.e., 'light', sugar- or fat-reduced) often have different packages than regular products, e.g., they may be less vibrantly coloured. People vary in their degree of health-interest and self-control ability and may be affected differently by package colour. This study assesses the extent to which package colour and participant characteristics interact and influence product perception and brain responses. Thirty-four healthy females performed a functional MRI task in which they viewed four differently coloured packages (regular vs. healthier; differing in brightness and saturation levels) with or without simultaneously tasting a either a regular or a healthier calorie-reduced drink. Results indicate main effects of package and taste and a package*taste interaction effect. Compared to healthier packages viewing regular packages enhanced activation in region implicated in inhibitory control (inferior frontal gyrus) and a reward-related region (striatum), the latter even more so as participants' health interest increased (r = 0.43, p = 0.01). Incongruent package-taste combinations decreased activation in the orbitofrontal cortex (OFC, a region implicated in reward representation) compared to congruent combinations. Tasting the healthier compared to regular product enhanced activation in the middle and superior frontal gyrus, which are implicated in inhibitory control, as well as the striatum and OFC, suggesting a cognitively driven preference for the healthier product. In conclusion, this paper provides evidence for the conditions under which package colour and taste properties modulate neural correlates related to reward and inhibition. Individual differences in health-interest and impulsivity influence package- and taste-related neural correlates and thus underscore the importance of taking participant characteristics into account in food research.",2019,"Compared to healthier packages viewing regular packages enhanced activation in region implicated in inhibitory control (inferior frontal gyrus) and a reward-related region (striatum), the latter even more so as participants' health interest increased (r = 0.43, p = 0.01).",['Thirty-four healthy females'],['functional MRI task in which they viewed four differently coloured packages (regular vs. healthier; differing in brightness and saturation levels) with or without simultaneously tasting a either a regular or a healthier calorie-reduced drink'],[],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205450', 'cui_str': '4'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",[],34.0,0.0231181,"Compared to healthier packages viewing regular packages enhanced activation in region implicated in inhibitory control (inferior frontal gyrus) and a reward-related region (striatum), the latter even more so as participants' health interest increased (r = 0.43, p = 0.01).","[{'ForeName': 'Irene O J M', 'Initials': 'IOJM', 'LastName': 'Tijssen', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Stippeneng 4, 6708, WE, Wageningen, the Netherlands.'}, {'ForeName': 'Paul A M', 'Initials': 'PAM', 'LastName': 'Smeets', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Stippeneng 4, 6708, WE, Wageningen, the Netherlands; Image Sciences Institute, University Medical Center, Utrecht Brain Center, Utrecht University, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.'}, {'ForeName': 'Robert P G', 'Initials': 'RPG', 'LastName': 'Goedegebure', 'Affiliation': 'Division of Marketing and Consumer Behaviour, Wageningen University, Hollandseweg 1, 6706, KN, Wageningen, the Netherlands.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Zandstra', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Stippeneng 4, 6708, WE, Wageningen, the Netherlands; Consumer Science, Unilever R&D Vlaardingen, Olivier van Noortlaan 120, 3133, AT, Vlaardingen, the Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'de Graaf', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Stippeneng 4, 6708, WE, Wageningen, the Netherlands.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Jager', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Stippeneng 4, 6708, WE, Wageningen, the Netherlands. Electronic address: gerry.jager@wur.nl.'}]",Appetite,['10.1016/j.appet.2019.104378']
3029,31348973,Caloric compensation ability around the age of 1 year: Interplay with the caregiver-infant mealtime interaction and infant appetitive traits.,"Previously, we demonstrated that infants' caloric compensation ability decreases between 11 and 15 months old. Here, we explored whether the inter-individual variation in infants' caloric compensation ability is associated with caregiver-infant interaction during laboratory test meals or with infant appetitive traits. To describe caregiver-infant interaction, we recorded feeding in laboratory ad libitum meals when the infants were 11 and 15 months old by using a connected weighing scale. We extracted the weight of each offered spoonful and the time interval between two spoonfuls. The caloric compensation score (COMPX) was assessed during the same meals. At 11 and 15 months old, the caregiver rated their infant's appetitive traits by completing the CEBQ-T. Student's t tests were applied to test the relationships between the variables describing the caregiver-infant interaction and the COMPX score. The relationships between the COMPX score or its change and the infants' appetitive traits were assessed with Kendall correlations. Regarding appetitive traits, the more the caloric compensation ability decreased between 11 and 15 months old, the more the infants were perceived as food responsive between these ages (τ = -0.36, p = 0.01, n = 28). At 11 months old, when the time interval between two spoonfuls was positively associated with the previous spoonful weight (i.e., a longer time interval after a larger spoonful weight), the infants exhibited a better caloric compensation ability (t = -2.1, p = 0.04, n = 38). Moreover, this study provides new evidence regarding the importance of a responsive feeding style by suggesting that adapting the feeding pace to the spoonful weight could be a favourable practice associated with better caloric compensation ability by the end of the first year. TRIAL REGISTRATION: This trial was registered at clinicals.gov as NCT03409042 (https://clinicaltrials.gov/ct2/show/NCT03409042).",2019,The relationships between the COMPX score or its change and the infants' appetitive traits were assessed with Kendall correlations.,[],[],"['caloric compensation score (COMPX', 'caloric compensation ability', 'caregiver-infant interaction and the COMPX score', 'previous spoonful weight']",[],[],"[{'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4518550', 'cui_str': 'Spoonful'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.031807,The relationships between the COMPX score or its change and the infants' appetitive traits were assessed with Kendall correlations.,"[{'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Brugaillères', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, Dijon, France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chabanet', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, Dijon, France.""}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Issanchou', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, Dijon, France.""}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, AgroSup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, Dijon, France. Electronic address: camille.schwartz@inra.fr.""}]",Appetite,['10.1016/j.appet.2019.104382']
3030,32976205,Intranasal dexmedetomidine versus oral midazolam premedication to prevent emergence delirium in children undergoing strabismus surgery: A randomised controlled trial.,"BACKGROUND


Dexmedetomidine is being used increasingly as a premedicant in the paediatric population. However, the effectiveness of pre-operative intranasal dexmedetomidine premedication, compared with oral midazolam, for emergence delirium is not well characterised.
OBJECTIVE


To identify the effectiveness of pre-operative intranasal dexmedetomidine for emergence delirium in the paediatric patient population following general anaesthesia.
DESIGN


A prospective, randomised, double-blind, parallel-group, placebo-controlled trial.
SETTING


Single university teaching hospital, from September 2013 to August 2014.
PATIENTS


One hundred and fifty-six patients undergoing anaesthesia for strabismus surgery were included in the study.
INTERVENTION


Patients were randomised in a 1 : 1 : 1 ratio to receive premedication with intranasal dexmedetomidine 2 μg kg (the dexmedetomidine group), oral midazolam 0.5 mg kg (the midazolam group), or 0.9% saline (the placebo group).
MAIN OUTCOME MEASURES


The primary outcome was the incidence of emergence delirium assessed by the Paediatric Anaesthesia Emergence Delirium scale. Secondary outcomes included the quality of the inhalational induction, emergence time, postoperative pain intensity, length of stay in the postanaesthesia care unit, the incidence of postoperative nausea or vomiting (PONV) and parents' satisfaction.
RESULTS


The incidence of emergence delirium was lower in patients given dexmedetomidine compared with that in patients given midazolam (11.5 versus 44%, relative risk = 0.262, 95% confidence interval 0.116 to 0.592) or 0.9% saline (11.5 versus 49%, relative risk = 0.235, 95% confidence interval 0.105 to 0.525). Likewise, the incidence of PONV was lower in the dexmedetomidine group (3.8%) than that in the midazolam (22%; P = 0.006) or placebo (29.4%; P < 0.001) groups. However, there was no difference among the groups concerning postoperative pain scores and length of postanaesthesia care unit stay.
CONCLUSION


In paediatric patients undergoing strabismus surgery intranasal dexmedetomidine 2 μg kg premedication decreases the incidence of emergence delirium and PONV, and improves parents' satisfaction compared with oral midazolam.
TRIAL REGISTRATION


ClinicalTrials.gov (identifier: NCT01895023).",2020,"However, there was no difference among the groups concerning postoperative pain scores and length of postanaesthesia care unit stay.
","['paediatric patients undergoing strabismus surgery intranasal', 'Single university teaching hospital, from September 2013 to August 2014', 'paediatric patient population following general anaesthesia', 'children undergoing strabismus surgery', 'One hundred and fifty-six patients undergoing anaesthesia for strabismus surgery were included in the study']","['pre-operative intranasal dexmedetomidine', 'midazolam premedication', 'Dexmedetomidine', 'placebo', 'dexmedetomidine', 'intranasal dexmedetomidine 2\u200aμg\u200akg (the dexmedetomidine group), oral midazolam 0.5\u200amg\u200akg (the midazolam group), or 0.9% saline (the placebo', 'midazolam', 'Intranasal dexmedetomidine']","[""quality of the inhalational induction, emergence time, postoperative pain intensity, length of stay in the postanaesthesia care unit, the incidence of postoperative nausea or vomiting (PONV) and parents' satisfaction"", 'incidence of emergence delirium', 'postoperative pain scores and length of postanaesthesia care unit stay', ""incidence of emergence delirium and PONV, and improves parents' satisfaction"", 'incidence of PONV', 'incidence of emergence delirium assessed by the Paediatric Anaesthesia Emergence Delirium scale']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0197981', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033045', 'cui_str': 'Premedication'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0412768', 'cui_str': 'Inhalational induction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",156.0,0.767456,"However, there was no difference among the groups concerning postoperative pain scores and length of postanaesthesia care unit stay.
","[{'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'From the Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University (YY, JL, WC, YL, XZ) and Department of Gynaecology, Fujian Cancer Hospital, Affiliated Hospital of Fujian Medical University (YS).'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'From the Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University (YY, JL, WC, YL, XZ) and Department of Gynaecology, Fujian Cancer Hospital, Affiliated Hospital of Fujian Medical University (YS).'}, {'ForeName': 'Jiancheng', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'From the Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University (YY, JL, WC, YL, XZ) and Department of Gynaecology, Fujian Cancer Hospital, Affiliated Hospital of Fujian Medical University (YS).'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'From the Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University (YY, JL, WC, YL, XZ) and Department of Gynaecology, Fujian Cancer Hospital, Affiliated Hospital of Fujian Medical University (YS).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'From the Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University (YY, JL, WC, YL, XZ) and Department of Gynaecology, Fujian Cancer Hospital, Affiliated Hospital of Fujian Medical University (YS).'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'From the Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University (YY, JL, WC, YL, XZ) and Department of Gynaecology, Fujian Cancer Hospital, Affiliated Hospital of Fujian Medical University (YS).'}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001270']
3031,32976217,Using Combined Tabletop and Simulation Activities to Improve Nursing Students' Attitudes About Quality Improvement: A Feasibility Study.,"Nursing students' attitudes about quality improvement (QI) reflect poor understanding of its importance. In a mixed-method interventional feasibility study, students received instruction about QI processes, plus information about factors contributing to central line-associated bloodstream infection (CLABSI) rates at a hypothetical hospital. Experimental group students observed a high-fidelity simulation bedside report for a CLABSI-affected patient. Both groups independently completed tabletop QI exercises to solve the CLABSI problem and had equivalent improvement in attitudes. Joint debriefing revealed how experimental group students developed greater understanding of interrelated, system-wide contributing factors. Hybrid learning activities with tabletop and simulation positively influence students' attitudes about QI.",2020,Both groups independently completed tabletop QI exercises to solve the CLABSI problem and had equivalent improvement in attitudes.,"[""Nursing Students' Attitudes""]",['Combined Tabletop and Simulation Activities'],[],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",[],,0.017394,Both groups independently completed tabletop QI exercises to solve the CLABSI problem and had equivalent improvement in attitudes.,"[{'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Gaffney', 'Affiliation': 'About the Authors The authors are faculty at the University of South Carolina College of Nursing, Aiken, South Carolina. Mary K. Gaffney, EdD, RN, is an assistant professor. Kay Lawrence, PhD, RN, CCRN-K, is an assistant professor. Katie A. Chargualaf, PhD, RN, CMSRN, is an assistant professor. For more information, contact Dr. Gaffney at MaryG@usca.edu.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Lawrence', 'Affiliation': ''}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Chargualaf', 'Affiliation': ''}]",Nursing education perspectives,['10.1097/01.NEP.0000000000000733']
3032,32976224,A Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for Laypeople: The MANI-CPR Trial.,"BACKGROUND


Compression-only cardiopulmonary resuscitation (CPR) is a suggested technique for laypeople facing out-of-hospital cardiac arrest (OHCA). However, it is difficult performing high-quality CPR until emergency medical services arrival with this technique. We aimed to verify whether incorporating intentional interruptions of different frequency and duration increases laypeople's CPR quality during an 8-minute scenario compared with compression-only CPR.
METHODS


We performed a multicenter randomized manikin study selecting participants from 2154 consecutive laypeople who followed a basic life support/automatic external defibrillation course. People who achieved high-quality CPR in 1-minute test on a computerized manikin were asked to participate. Five hundred seventy-six were enrolled, and 59 were later excluded for technical reasons or incorrect test recording. Participants were randomized in an 8-minute OHCA scenario using 3 CPR protocols (30 compressions and 2-second pause, 30c2s; 50 compressions and 5-second pause, 50c5s; 100 compressions and 10-second pause, 100c10s) or compression-only technique. The main outcome was the percentage of chest compressions with adequate depth.
RESULTS


Five hundred seventeen participants were evaluated. There was a statistically significant difference regarding the percentage of compressions with correct depth among the groups (30c2s, 96%; 50c5s, 96%; 100c10s, 92%; compression only, 79%; P = 0.006). Post hoc comparison showed a significant difference for 30c2s (P = 0.023) and for 50c5s (P = 0.003) versus compression only. Regarding secondary outcome, there were a higher chest compression fraction in the compression-only group and a higher rate of pauses longer than 10 seconds in the 100c10s.
CONCLUSIONS


In a simulated OHCA, 30c2s and 50c5s protocols were characterized by a higher rate of chest compressions with correct depth than compression only. This could have practical consequences in laypeople CPR training and recommendations.
CLINICAL TRIAL REGISTRATION


NCT02632500.",2020,"There was a statistically significant difference regarding the percentage of compressions with correct depth among the groups (30c2s, 96%; 50c5s, 96%; 100c10s, 92%; compression only, 79%; P = 0.006).","['Five hundred seventeen participants were evaluated', 'Five hundred seventy-six were enrolled, and 59 were later excluded for technical reasons or incorrect test recording', 'participants from 2154 consecutive laypeople who followed a basic life support/automatic external defibrillation course']","['Cardiopulmonary Resuscitation', 'Compression-only cardiopulmonary resuscitation (CPR', 'OHCA scenario using 3 CPR protocols (30 compressions and 2-second pause, 30c2s; 50 compressions and 5-second pause, 50c5s; 100 compressions and 10-second pause, 100c10s) or compression-only technique']","['chest compression fraction', 'percentage of chest compressions with adequate depth', 'percentage of compressions with correct depth', ""laypeople's CPR quality""]","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",517.0,0.101402,"There was a statistically significant difference regarding the percentage of compressions with correct depth among the groups (30c2s, 96%; 50c5s, 96%; 100c10s, 92%; compression only, 79%; P = 0.006).","[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Baldi', 'Affiliation': ""From the Pavia nel Cuore (E.B., E.C., M.P., C.B.), Pavia; Robbio nel Cuore (E.B., E.C., D.B.), Robbio; Department of Molecular Medicine (E.B.), Section of Cardiology, University of Pavia; Cardiac Intensive Care Unit, Arrhythmia and Electrophysiology and Experimental Cardiology (E.B.), Fondazione IRCCS Policlinico San Matteo; AAT 118 Pavia (E.C.), AREU Lombardia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; Swiss Resuscitation Council (R.B.), Bern, Switzerland; Fondazione Ticino Cuore (R.B.), Breganzona, Switzerland; Department of Public Health, Experimental and Forensic Medicine (P.B., O.E.F.), Unit of Biostatistics and Clinical Epidemiology, University of Pavia; Department of Clinical-Surgical, Pediatric and Diagnostic Sciences-Anesthesia, Intensive Care and Pain Therapy (M.P.), University of Pavia, Pavia; Department of Surgical, Oncological and Oral Sciences (Di.Chir.On.S.), Department of Anesthesia Intensive Care and Emergency (M.P., A.C.), Policlinico Paolo Giaccone, University of Palermo, Palermo, Italy; Federazione Cantonale Ticinese Servizi Autoambulanze (C.T.), Lugano; Accademia di Medicina d'Urgenza Ticinese (AMUT) (C.T.), Breganzona, Switzerland; Emergency Training Center (D.L.), Cugy, Switzerland; Centro Studi e Formazione Gymnasium (S.B.), Pordenone, Italy; École Supérieure d'Ambulancier et Soins d'Urgence Romande (ES-ASUR) (S.D.), Lausanne; and Formamed Sàrl (M.T.), Cortaillod, Switzerland.""}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Contri', 'Affiliation': ''}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Burkart', 'Affiliation': ''}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Borrelli', 'Affiliation': ''}, {'ForeName': 'Ottavia Eleonora', 'Initials': 'OE', 'LastName': 'Ferraro', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Paglino', 'Affiliation': ''}, {'ForeName': 'Marinella', 'Initials': 'M', 'LastName': 'Pugliesi', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Barbati', 'Affiliation': ''}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Bertaia', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tami', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': ''}, {'ForeName': 'Susi', 'Initials': 'S', 'LastName': 'Boldarin', 'Affiliation': ''}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Dénéréaz', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Terrapon', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cortegiani', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000505']
3033,32976269,Optimization of Contrast Agent Dosage on Contrast-Enhanced T2 Fluid-Attenuated Inversion Recovery: An In Vitro and In Vivo Study.,"OBJECTIVE


This study aimed to ascertain the minimum gadolinium dosage on contrast-enhanced (CE) T2 fluid-attenuated inversion recovery (FLAIR) at appropriate imaging time.
METHODS


Different dosages of gadodiamide were imaged with a 3.0-T magnetic resonance scanner for T2-FLAIR and T1WI. Twenty glioma-induced rat models were randomly assigned into 4 groups (1/2, 1/4, 1/6, 1/8 of routine dosage) and imaged for T2-FLAIR and T1WI preinjection and postinjection of gadodiamide. Contrast-enhanced T2-FLAIR was acquired for 8 repetitions postinjection. Enhancement effects were assessed by calculating contrast-noise ratio and contrast ratio using Kruskal-Wallis and Mann-Whitney rank sum test.
RESULTS


The in vitro experiment showed that gadodiamide at 1/4 of the T1WI dosage presented the best contrast on CE-T2-FLAIR. For in vivo study, the best enhancement effect on CE-T2-FLAIR was achieved at 1/2 of the routine dosage at 8 to 12 minutes of delayed scanning. Compared with CE-T1WI at routine dosage, CE-T2-FLAIR at 1/2 gadodiamide dosage presented similar enhancement effects with no statistical difference (P = 0.244 and 0.090 for contrast-noise ratio and contrast ratio, respectively).
CONCLUSIONS


Contrast-enhanced T2-FLAIR imaging with half of T1WI routine gadodiamide dosage can produce similar enhancement effects to CE-T1WI when characterizing brain gliomas. The cut-down of contrast agent dosage may help reduce gadolinium accumulation in certain tissues.",2020,"Compared with CE-T1WI at routine dosage, CE-T2-FLAIR at 1/2 gadodiamide dosage presented similar enhancement effects with no statistical difference (P = 0.244 and 0.090 for contrast-noise ratio and contrast ratio, respectively).
",['Twenty glioma-induced rat models'],"['gadodiamide', 'contrast-enhanced (CE) T2 fluid-attenuated inversion recovery (FLAIR']","['Contrast-Enhanced T2 Fluid-Attenuated Inversion Recovery', 'CE-T2-FLAIR', 'contrast-noise ratio and contrast ratio using Kruskal-Wallis and Mann-Whitney rank sum test']","[{'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0082646', 'cui_str': 'gadodiamide'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242928', 'cui_str': 'Rank-Sum Tests'}]",20.0,0.0151989,"Compared with CE-T1WI at routine dosage, CE-T2-FLAIR at 1/2 gadodiamide dosage presented similar enhancement effects with no statistical difference (P = 0.244 and 0.090 for contrast-noise ratio and contrast ratio, respectively).
","[{'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Rui', 'Affiliation': 'From the Department of Radiology, Huashan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Jin', 'Affiliation': 'From the Department of Radiology, Huashan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Radiology, Huashan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Radiology, Huashan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'From the Department of Radiology, Huashan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Shiman', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'From the Department of Radiology, Huashan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'General Electric Company, Pharmaceutical Diagnostics Medical Affairs, Shanghai, PR China.'}, {'ForeName': 'Junhai', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Radiology, Huashan Hospital, Fudan University, Shanghai.'}, {'ForeName': 'Zhenwei', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'From the Department of Radiology, Huashan Hospital, Fudan University, Shanghai.'}]",Journal of computer assisted tomography,['10.1097/RCT.0000000000001055']
3034,32976274,"Response to Comment on ""Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study-A Randomized Clinical Trial'.",,2020,,"[""Crohn's Disease""]",[],[],"[{'cui': 'C0010346', 'cui_str': ""Crohn's disease""}]",[],[],,0.0849122,,"[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples Naples, Italy Gastroenterology and Endoscopy Unit, AORN Antonio Cardarelli Naples, Italy Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': ''}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004129']
3035,32976331,The Effect of Photographic Visual Aids in Preoperative Patient Counseling in Oculoplastic Surgery.,"PURPOSE


To investigate the effect of visual supplementation and its mode of delivery in preoperative counseling of patients undergoing oculoplastic surgery.
METHODS


A prospective randomized controlled trial of consecutive patients undergoing oculoplastic eyebrow and eyelid surgery was conducted. Patients were randomized to an ""oral only"" group receiving routine preoperative oral counseling or an ""oral and visual"" group receiving identical counseling visually supplemented with photographs demonstrating common postoperative physical findings. Patients in the ""oral and visual"" group were further randomized to receive education from the medical team in person versus prerecorded video. Patient emotions and expectations regarding postoperative healing were assessed preoperatively and at 1 week and 2 months postoperatively.
RESULTS


103 patients were included: 32 received in-person oral education, 33 received in-person oral education with photographs, and 38 received education with photographs via video. There were no significant differences in demographics or preoperative patient fear, anxiety, or preparedness. The ""oral and visual"" group expected more severe postsurgical discomfort and physical findings at postoperative day 1 and week 1. There were no significant differences between groups in surgery signup, cancellation, or triage call rates; patient expectations of postoperative months 2 and 4; or in anxiety, preparedness, or satisfaction.
CONCLUSIONS


Visual supplementation in preoperative counseling increases patient expectations of postoperative physical findings without escalating fear or anxiety, and has no significant impact on patient emotions, triage call rates, and satisfaction throughout their surgical experience. Preoperative education via video is perceived by patients to be equivalent to counseling in person by the surgeon.",2020,"The ""oral and visual"" group expected more severe postsurgical discomfort and physical findings at postoperative day 1 and week 1.","['103 patients were included: 32 received in-person oral education, 33 received in-person oral education with photographs, and 38 received education with photographs via video', 'Preoperative Patient Counseling in Oculoplastic Surgery', 'patients undergoing oculoplastic surgery', 'consecutive patients undergoing']","['Visual supplementation', 'visual supplementation', 'education from the medical team in person versus prerecorded video', 'oculoplastic eyebrow and eyelid surgery', 'oral only"" group receiving routine preoperative oral counseling or an ""oral and visual"" group receiving identical counseling visually supplemented with photographs demonstrating common postoperative physical findings', 'Photographic Visual Aids']","['Patient emotions and expectations regarding postoperative healing', 'patient emotions, triage call rates, and satisfaction', 'demographics or preoperative patient fear, anxiety, or preparedness', 'severe postsurgical discomfort and physical findings', 'surgery signup, cancellation, or triage call rates; patient expectations of postoperative months 2 and 4; or in anxiety, preparedness, or satisfaction']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0600047', 'cui_str': 'Patient counseled'}, {'cui': 'C1720208', 'cui_str': 'Ophthalmic plastic surgery'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015420', 'cui_str': 'Eyebrow structure'}, {'cui': 'C0015426', 'cui_str': 'Eyelid structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0042813', 'cui_str': 'Visual Aids'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",103.0,0.0521746,"The ""oral and visual"" group expected more severe postsurgical discomfort and physical findings at postoperative day 1 and week 1.","[{'ForeName': 'Kelly H', 'Initials': 'KH', 'LastName': 'Yom', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Shriver', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Carter', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Bobby S', 'Initials': 'BS', 'LastName': 'Korn', 'Affiliation': 'Department of Ophthalmology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Don O', 'Initials': 'DO', 'LastName': 'Kikkawa', 'Affiliation': 'Department of Ophthalmology, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Audrey C', 'Initials': 'AC', 'LastName': 'Ko', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa.'}]",Ophthalmic plastic and reconstructive surgery,['10.1097/IOP.0000000000001817']
3036,32651998,Maternal dietary diversity and dietary quality scores in relation to adverse birth outcomes in Tanzanian women.,"BACKGROUND


Preterm birth (PTB), small for gestational age (SGA), and low birth weight (LBW) are risk factors for morbidity and mortality among infants. High-quality maternal diets during pregnancy may protect against these adverse birth outcomes.
OBJECTIVES


The aim of this study was to prospectively examine the association of maternal dietary diversity and quality during pregnancy with birth outcomes among women in Dar es Salaam, Tanzania.
METHODS


We analyzed data from 7553 HIV-negative pregnant women enrolled in a multivitamin trial at 12-27 weeks of gestation. Dietary intake was assessed using 24-h dietary recalls. Dietary diversity scores (DDS; range: 0-10) were computed as the number of food groups consumed by women, using FAO's Minimum Dietary Diversity for Women index. The Prime Diet Quality Score (PDQS; range: 0-42) assessed maternal diet quality based on consumption of 21 healthy and unhealthy food groups. Log binomial regression methods were used to assess associations of DDS and PDQS with PTB, SGA, LBW, and fetal loss.
RESULTS


In the previous 24 h, 99.9% of all women had consumed cereal and staples, 57.9% meats, 4.7% eggs, and 0.5% nuts and seeds. Median DDS was 3.0 (IQR: 2.5-3.5). For the PDQS, all women consumed ≥4 servings/wk of green leafy vegetables and refined grains. Higher DDS was associated with lower risk of SGA (RR highest compared with lowest quintile: 0.74; 95% CI: 0.62, 0.89). Higher PDQS was associated with lower risk of PTB (RR highest compared with lowest quintile: 0.55; 95% CI: 0.46, 0.66), LBW (RR: 0.53; 95% CI: 0.40, 0.70), and fetal loss (RR: 0.53; 95% CI, 0.34, 0.82).
CONCLUSIONS


PDQS was inversely associated with PTB, LBW, and fetal loss, and DDS was inversely associated with SGA. These findings suggest that in addition to dietary diversity, diet quality should be considered as important in understanding dietary risk factors for poor birth outcomes.This trial was registered at clinicaltrials.gov as NCT00197548.",2020,"Higher PDQS was associated with lower risk of PTB (RR highest compared with lowest quintile: 0.55; 95% CI: 0.46, 0.66), LBW (RR: 0.53; 95% CI: 0.40, 0.70), and fetal loss (RR: 0.53; 95% CI, 0.34, 0.82).
","['Tanzanian women', '7553 HIV-negative pregnant women enrolled in a multivitamin trial at 12-27 weeks of gestation', 'women in Dar es Salaam, Tanzania']",[],"['PTB, LBW, and fetal loss, and DDS', 'fetal loss', 'Maternal dietary diversity and dietary quality scores', 'maternal diet quality', 'Dietary intake', 'Median DDS', 'Prime Diet Quality Score', 'DDS and PDQS with PTB, SGA, LBW, and fetal loss', 'Dietary diversity scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]",[],"[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}]",7553.0,0.24143,"Higher PDQS was associated with lower risk of PTB (RR highest compared with lowest quintile: 0.55; 95% CI: 0.46, 0.66), LBW (RR: 0.53; 95% CI: 0.40, 0.70), and fetal loss (RR: 0.53; 95% CI, 0.34, 0.82).
","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Madzorera', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Isanaka', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Molin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Departments of Epidemiology and Biostatistics, Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Gernard I', 'Initials': 'GI', 'LastName': 'Msamanga', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Urassa', 'Affiliation': 'Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Hertzmark', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Duggan', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa172']
3037,32882355,Psychological Distress in Bereaved Caregivers of Patients With Advanced Cancer.,"CONTEXT


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


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


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


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


Many bereaved caregivers of patients with advanced cancer experience symptoms of depression and anxiety, which are associated with their perceptions of distress in their loved ones at the EOL.",2020,Caregiver ratings of worse physical (B = 0.32; P = 0.009) and psychological (B = 0.50; P < 0.001) distress experienced by the patient at the EOL were associated with worse depression symptoms in bereaved caregivers.,"['Bereaved Caregivers of Patients With Advanced Cancer', '168 caregivers enrolled in a supportive care trial for patients with incurable lung and gastrointestinal cancers and their caregivers', 'bereaved caregivers of patients with advanced cancer', ""patients with advanced cancer (caregivers) experience psychological distress during the patient's illness course"", 'patients at the EOL']",[],"['anxiety symptoms and their ratings of physical and psychological distress', 'caregiver rating of worse psychological distress', 'Psychological Distress', ""patient's physical and psychological distress"", 'Caregiver ratings of worse physical', ""Hospital Anxiety and Depression Scale to assess caregivers' depression and anxiety symptoms"", 'depression and anxiety symptoms']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",[],"[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",168.0,0.0825236,Caregiver ratings of worse physical (B = 0.32; P = 0.009) and psychological (B = 0.50; P < 0.001) distress experienced by the patient at the EOL were associated with worse depression symptoms in bereaved caregivers.,"[{'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA. Electronic address: ael-jawahri@partners.org.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Vicki A', 'Initials': 'VA', 'LastName': 'Jackson', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA; Division of Palliative Care, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA; Division of Palliative Care, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Simone P', 'Initials': 'SP', 'LastName': 'Rinaldi', 'Affiliation': 'Division of Palliative Care, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Gallagher', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Annemarie D', 'Initials': 'AD', 'LastName': 'Jagielo', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Carlisle E W', 'Initials': 'CEW', 'LastName': 'Topping', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Elyze', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Bailey', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Division of Hematology & Oncology, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.08.028']
3038,30923816,Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease.,"BACKGROUND


Untreated, chronic hepatitis C virus (HCV) infection may lead to progressive liver damage, which can be mitigated by successful treatment. This integrated analysis reports the safety, efficacy, and pharmacokinetics (PK) of the ribavirin-free, direct-acting, antiviral, fixed-dose combination of glecaprevir/pibrentasvir (G/P) in patients with chronic HCV genotype 1-6 infections and compensated liver disease, including patients with chronic kidney disease stages 4 or 5 (CKD 4/5).
METHODS


Data from 9 Phase II and III clinical trials, assessing the efficacy and safety of G/P treatment for 8-16 weeks, were included. The presence of cirrhosis was determined at screening using a liver biopsy, transient elastography, or serum biomarkers. The objectives were to evaluate safety, the rate of sustained virologic response at post-treatment week 12 (SVR12), and steady-state PK by cirrhosis status.
RESULTS


Among 2369 patients, 308 (13%) were Child-Pugh Class A, including 20 with CKD 4/5. Overall, <1% of patients experienced an adverse event (AE) that led to G/P discontinuation or G/P-related serious AEs (SAEs). The most common AEs were headache and fatigue, occurring at similar frequencies with and without cirrhosis. SAEs were more common in patients with CKD 4/5, but all were unrelated to G/P. There were no cases of drug-induced liver injury or clinically relevant hepatic decompensation. SVR12 rates were 96.4% (297/308) with compensated cirrhosis and 97.5% (2010/2061) without cirrhosis. PK analysis demonstrated a 2.2-fold increase in glecaprevir exposure, but not pibrentasvir exposure, in patients with compensated cirrhosis.
CONCLUSIONS


G/P was safe and efficacious in patients with compensated liver disease, including those with CKD 4/5.
CLINICAL TRIALS REGISTRATION


NCT02243280, NCT02243293, NCT02604017, NCT02640482, NCT02640157, NCT02636595, NCT02642432, NCT02651194, and NCT02446717.",2019,There were no cases of drug-induced liver injury or clinically relevant hepatic decompensation.,"['Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease', 'patients with compensated cirrhosis', 'patients with compensated liver disease, including those with CKD 4/5', '2369 patients, 308 (13%) were Child-Pugh Class A, including 20 with CKD 4/5', 'patients with chronic HCV genotype 1-6 infections and compensated liver disease, including patients with chronic kidney disease stages 4 or 5 (CKD 4/5']","['glecaprevir/pibrentasvir (G/P', 'Glecaprevir/Pibrentasvir']","['adverse event (AE', 'SVR12 rates', 'glecaprevir exposure', 'efficacy and safety', 'drug-induced liver injury or clinically relevant hepatic decompensation', 'headache and fatigue', 'safety, efficacy, and pharmacokinetics (PK', 'rate of sustained virologic response']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C3839044', 'cui_str': 'Compensated liver disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2317473', 'cui_str': 'Chronic kidney disease stage 4'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3805156', 'cui_str': 'Chronic hepatitis C virus genotype 1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4519536', 'cui_str': 'glecaprevir'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0860207', 'cui_str': 'Drug-induced disorder of liver'}, {'cui': 'C1394798', 'cui_str': 'Hepatic decompensation'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",2369.0,0.0352375,There were no cases of drug-induced liver injury or clinically relevant hepatic decompensation.,"[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Gane', 'Affiliation': 'Auckland Clinical Studies, New Zealand.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Poordad', 'Affiliation': 'The Texas Liver Institute, University of Texas Health Science Center, San Antonio.'}, {'ForeName': 'Neddie', 'Initials': 'N', 'LastName': 'Zadeikis', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Valdes', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Lin', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Armen', 'Initials': 'A', 'LastName': 'Asatryan', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stedman', 'Affiliation': 'Christchurch Hospital and University of Otago, New Zealand.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Greenbloom', 'Affiliation': 'Toronto Digestive Disease Associates, Ontario, Canada.'}, {'ForeName': 'Tuan', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Research and Education, Inc, San Diego, California.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'Elkhashab', 'Affiliation': 'Toronto Liver Centre, Ontario, Canada.'}, {'ForeName': 'Marcus-Alexander', 'Initials': 'MA', 'LastName': 'Wörns', 'Affiliation': 'Universitätsmedizin der Johannes-Gutenberg Universität, Mainz, Germany.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Tran', 'Affiliation': 'University Hospital of Nice, Digestive Centre, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Mulkay', 'Affiliation': 'Hôpital Centre Hospitalier Universitaire Saint-Pierre, Brussels, Belgium.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Setze', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Pilot-Matias', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Porcalla', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}, {'ForeName': 'Federico J', 'Initials': 'FJ', 'LastName': 'Mensa', 'Affiliation': 'AbbVie Inc., North Chicago, Illinois.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz022']
3039,31305270,Pharmacokinetics of pertuzumab administered concurrently with trastuzumab in Chinese patients with HER2-positive early breast cancer.,"In the APHINITY study (NCT01358877, BIG 4-11/BO25126/TOC4939G), pertuzumab added to trastuzumab and chemotherapy significantly improved invasive disease-free survival as adjuvant treatment for patients with HER2-positive early breast cancer. The objective of this analysis was to assess the pharmacokinetics of pertuzumab in combination with trastuzumab in Chinese patients with early breast cancer. Samples for pertuzumab and trastuzumab pharmacokinetic analysis were taken from Chinese patients during cycle 1 of treatment and at steady-state in cycle 10. Noncompartmental analysis was used to estimate minimum and maximum serum concentrations (Cmax and Cmin), area under the concentration-time curve, clearance, and other pharmacokinetic parameters. In 15 patients, mean steady-state Cmax and Cmin pertuzumab serum concentrations (368 ± 177 μg/ml, and 122 ± 47 μg/ml, respectively) were numerically higher than observed previously in a pharmacokinetic analysis of the global population in APHINITY and in patients treated in the metastatic setting. The geometric mean ratio and corresponding 90% confidence interval for trastuzumab Cmax and Cmin in the presence (n = 15) or absence (n = 17) of pertuzumab were 104.6 (91.09-120) and 98.23 (84.58-114), respectively, indicating no apparent impact of pertuzumab on the pharmacokinetics of trastuzumab. Increases in pertuzumab Cmax and Cmin were not associated with an increase in adverse events. The APHINITY Chinese pharmacokinetic substudy analysis supports the dosing regimen for pertuzumab (840 mg loading dose followed by 420 mg maintenance doses every 3 weeks administered by intravenous infusion) in a Chinese HER2-positive early breast cancer patient population.",2019,Increases in pertuzumab Cmax and Cmin were not associated with an increase in adverse events.,"['Chinese patients with HER2-positive early breast cancer', 'Chinese patients with early breast cancer', 'Chinese HER2-positive early breast cancer patient population', 'patients with HER2-positive early breast cancer']","['trastuzumab', 'pertuzumab added to trastuzumab and chemotherapy', 'pertuzumab']","['mean steady-state Cmax and Cmin pertuzumab serum concentrations', 'maximum serum concentrations (Cmax and Cmin), area under the concentration-time curve, clearance, and other pharmacokinetic parameters', 'invasive disease-free survival', 'pertuzumab Cmax and Cmin', 'geometric mean ratio', 'adverse events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0335247,Increases in pertuzumab Cmax and Cmin were not associated with an increase in adverse events.,"[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, Changchun.'}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Academy of Military Medical Sciences Affiliated Hospital (307 Hospital of PLA), Beijing.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'The Tumor Hospital of Harbin Medical University, Harbin.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Shanghai First People's Hospital, Shanghai.""}, {'ForeName': 'Yixiang', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Roche China Holdings, Shanghai.'}, {'ForeName': 'Vivianne C G', 'Initials': 'VCG', 'LastName': 'Tjan-Heijnen', 'Affiliation': 'Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'McConnell', 'Affiliation': 'Frontier Science (Scotland) Ltd, Kincraig, Scotland.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bejarano', 'Affiliation': 'Breast International Group, Brussels, Belgium.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Fumagalli', 'Affiliation': 'Breast International Group, Brussels, Belgium.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Bines', 'Affiliation': 'National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Genentech, Inc., South San Francisco.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'Genentech, Inc., South San Francisco.'}, {'ForeName': 'Whitney P', 'Initials': 'WP', 'LastName': 'Kirschbrown', 'Affiliation': 'Genentech, Inc., South San Francisco.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing.'}]",Anti-cancer drugs,['10.1097/CAD.0000000000000808']
3040,32976088,Contralateral Effects of Eccentric Exercise and DOMS of the Plantar Flexors: Evidence of Central Involvement.,"Purpose : Peripheral and central factors play important roles in the reduction of motor performance following damaging eccentric exercise and delayed onset muscle soreness (DOMS). Following this regime, contralateral limbs could also be affected; however, the factors involved remain inconclusive. The purpose of this study was to distinguish the peripheral and central factors following eccentric contraction and DOMS of the plantar flexors in treated and contralateral homologous limbs.  Methods : Ten males (BMI = 25.08 ± 1.69kgm -2 ; age = 28.70 ± 4.24 years) were randomly assigned to experimental (DOM) or control (CON) groups. The DOM group performed a damaging eccentric exercise, while the CON group rested. Plasma creatine kinase (CK), pain rating scale (PRS), muscle stiffness, maximal voluntary contraction (MVC), and neural voluntary activation (VA) were measured before, after 10 min, and after 24, 48, and 72 hr on treated and contralateral limbs.  Results : Following exercise, CK increased until after 48 hr, while PRS increased until after 72 hr compared to the CON group. Importantly, MVC was reduced at all time points, with the greatest reduction observed after 24 hr (-16%), while VA was affected until after 48 hr, with the greatest reduction at after 10 min (-7%). Interestingly, a ""cross-over effect"" was observed in contralateral limbs when PRS, MVC, and VA were negatively affected following the same pattern (time line) as treated limbs (-13% peak MVC reduction; -3.5% peak VA reduction).  Conclusion : These findings suggest a substantial central contribution to the reduction in force immediately following eccentric exercise and to a lesser extent during the latter part of DOMS in both treated and contralateral limbs.",2020,"Plasma creatine kinase (CK), pain rating scale (PRS), muscle stiffness, maximal voluntary contraction (MVC), and neural voluntary activation (VA) were measured before, after 10 min, and after 24, 48, and 72 hr on treated and contralateral limbs.  ","['Methods : Ten males (BMI\xa0=\xa025.08\xa0±\xa01.69kgm', '2 ; age\xa0=\xa028.70\xa0±\xa04.24\xa0years']","['CON', 'Eccentric Exercise and DOMS', 'experimental (DOM) or control (CON', 'damaging eccentric exercise']","['Plasma creatine kinase (CK), pain rating scale (PRS), muscle stiffness, maximal voluntary contraction (MVC), and neural voluntary activation (VA', 'MVC']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]","[{'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",,0.0732572,"Plasma creatine kinase (CK), pain rating scale (PRS), muscle stiffness, maximal voluntary contraction (MVC), and neural voluntary activation (VA) were measured before, after 10 min, and after 24, 48, and 72 hr on treated and contralateral limbs.  ","[{'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Marathamuthu', 'Affiliation': 'University of Malaya.'}, {'ForeName': 'Victor Selvarajah', 'Initials': 'VS', 'LastName': 'Selvanayagam', 'Affiliation': 'University of Malaya.'}, {'ForeName': 'Ashril', 'Initials': 'A', 'LastName': 'Yusof', 'Affiliation': 'University of Malaya.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2020.1819526']
3041,32976346,Sound Quality Ratings of Amplified Speech and Music Using a Direct Drive Hearing Aid: Effects of Bandwidth.,"OBJECTIVE


To determine sound quality for extended bandwidth amplification using a direct drive hearing device.
STUDY DESIGN


Prospective double-blind within-subjects repeated measures study.
SETTING


University hearing research laboratories.
PATIENTS


Fifteen experienced hearing aid users with symmetric mild-sloping-to-severe sensorineural hearing loss.
INTERVENTION(S)


Sound quality ratings of speech and music passages were obtained using the Multiple Stimulus with Hidden References and Anchors (MUSHRA) protocol after wearing a direct drive hearing aid for at least 4 weeks. Passages were processed to filter out low-frequency (below 123 and 313 Hz) and high-frequency (above 4455, 5583, 6987, and 10,869 Hz) energy.
MAIN OUTCOME MEASURE(S)


Comparison of sound quality ratings for speech and music between low and high-pass filter frequencies measured from 0 to 100, where 0 represents ""bad"" and 100 represents ""excellent.""
RESULTS


Wider bandwidth stimuli received higher sound quality ratings compared with narrower bandwidth stimuli. Conditions with more low-frequency energy (full-band and 123 Hz cut-off) were rated as having higher sound quality. More low-frequency energy in the 123 Hz condition was rated as having higher sound versus the 313 Hz condition (mean difference: 11.2%, p = 0.001). Full-band conditions with more low- and high-frequency energy were higher than the other high-frequency cutoff conditions (mean difference range: 12.9-15%, p < 0.001).
CONCLUSIONS


The direct drive system provides higher sound quality of both speech and music compared to narrowband conditions. Sound quality improvements were mainly attributable to low-frequency sound, but stimuli with specific high-frequency content were rated with higher sound quality when additional high-frequency energy was present.",2020,"Full-band conditions with more low- and high-frequency energy were higher than the other high-frequency cutoff conditions (mean difference range: 12.9-15%, p < 0.001).
","['Fifteen experienced hearing aid users with symmetric mild-sloping-to-severe sensorineural hearing loss', 'University hearing research laboratories']",[],"['sound quality ratings for speech and music between low and high-pass filter frequencies', 'Sound quality improvements', 'Sound quality ratings of speech and music passages', 'sound quality ratings']","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022886', 'cui_str': 'Laboratory Research'}]",[],"[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0439799', 'cui_str': 'Channel'}]",,0.0480958,"Full-band conditions with more low- and high-frequency energy were higher than the other high-frequency cutoff conditions (mean difference range: 12.9-15%, p < 0.001).
","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Vaisberg', 'Affiliation': 'National Centre for Audiology, Western University, Department of Otolarygology.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Folkeard', 'Affiliation': 'National Centre for Audiology, Western University, Department of Otolarygology.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Levy', 'Affiliation': 'Earlens Corporation, Menlo Park, California.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Dundas', 'Affiliation': 'Earlens Corporation, Menlo Park, California.'}, {'ForeName': 'Sumit', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'National Centre for Audiology, Western University, Department of Otolarygology.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Scollie', 'Affiliation': 'National Centre for Audiology, Western University, Department of Otolarygology.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002915']
3042,32976362,"Brief Enhanced Partner Notification and Risk Reduction Counseling to Prevent Sexually Transmitted Infections, Cape Town, South Africa.","BACKGROUND


Evidence-based interventions are needed to stem sexually transmitted infections (STI). Clinic-delivered counseling remains an important avenue for effective STI prevention.
METHODS


A 3-arm randomized clinical trial compared: (a) STI health education control condition; (b) risk reduction counseling and (c) enhanced partner notification counseling. Men and women (N =1050) were recruited from an STI clinic in Cape Town, South Africa. Following baseline assessments, participants were randomly allocated to receive one of the three single session counseling interventions and were followed for 9-months of behavioral assessments and 12-months of electronic medical records abstraction for STI clinic services.
RESULTS


Sexual risk reduction counseling reported greater condom use than the other two conditions over the 3- and 6-months follow-ups. In addition, women receiving risk reduction counseling were significantly less likely to have returned for STI clinic services, but did not differ in the number of STI clinic visits over the year.
CONCLUSIONS


Brief single session STI prevention counseling demonstrates significant targeted outcomes. The findings suggest counseling approaches to both increase condom use and enhance partner notification may offer more robust and sustained outcomes and should be tested in future research.",2020,"RESULTS


Sexual risk reduction counseling reported greater condom use than the other two conditions over the 3- and 6-months follow-ups.","['Sexually Transmitted Infections, Cape Town, South Africa', 'Men and women (N =1050) were recruited from an STI clinic in Cape Town, South Africa']","['Brief Enhanced Partner Notification and Risk Reduction Counseling', 'STI health education control condition; (b) risk reduction counseling and (c) enhanced partner notification counseling', 'single session counseling interventions and were followed for 9-months of behavioral assessments and 12-months of electronic medical records abstraction for STI clinic services']",['number of STI clinic visits'],"[{'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0079990', 'cui_str': 'Partner Notification'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",1050.0,0.0574889,"RESULTS


Sexual risk reduction counseling reported greater condom use than the other two conditions over the 3- and 6-months follow-ups.","[{'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs, Connecticut, US.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Banas', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs, Connecticut, US.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Kalichman', 'Affiliation': 'Institute for Collaboration on Health, Intervention, and Policy, University of Connecticut, Storrs, Connecticut, US.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dewing', 'Affiliation': 'Health Systems Research Unit, Medical Research Council, South Africa.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Jennings', 'Affiliation': 'City Health Directorate of Cape Town, South Africa.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'City Health, Health Information and Technology, South Africa.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Berteler', 'Affiliation': 'City Health, Health Information and Technology, South Africa.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mathews', 'Affiliation': 'Health Systems Research Unit, Medical Research Council, South Africa.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001295']
3043,32976365,Pro-IL-1β Is an Early Prognostic Indicator of Severe Donor Lung Injury During Ex Vivo Lung Perfusion.,"BACKGROUND


Ex vivo lung perfusion (EVLP) is used to evaluate and recondition extended criteria donor lungs for transplantation. Interleukin-1β (IL-1β) has been identified as a prognostic indicator of nonrecovery during EVLP. This may be an effect of inflammasome activation or cellular necrosis following donation and graft preservation. Delineating the mechanism of IL-1β release is required.
METHODS


The inactive intracellular precursor molecule, pro-IL-1β, was characterised along with the pro-IL-1β processing enzyme, caspase-1, in the perfusate of n=20 human lungs that had undergone EVLP (n=10 lungs that failed to recover and were discarded vs n=10 lungs that reconditioned and were transplanted). In an experimental porcine model, n=8 lungs underwent EVLP and were randomised to receive either a specific NLRP3 inflammasome inhibitor or control.
RESULTS


Significant increases in pro-IL-1β and caspase-1 were observed in the perfusate from human lungs that did not recondition during EVLP compared to those that successfully reconditioned and were used for transplantation. Within the porcine EVLP, NLRP3 inflammasome inhibition reduced IL-1β within the perfusate compared to controls, but this had no impact on lung function, hemodynamics, or inflammation.
CONCLUSIONS


Our data suggest that pro-IL-1β is passively released following cellular necrosis of the donor lung.",2020,"Within the porcine EVLP, NLRP3 inflammasome inhibition reduced IL-1β within the perfusate compared to controls, but this had no impact on lung function, hemodynamics, or inflammation.
","['n=8 lungs underwent', 'n=20 human lungs that had undergone EVLP (n=10 lungs that failed to recover and were discarded vs n=10 lungs that reconditioned and were transplanted', 'Severe Donor Lung Injury']","['Ex vivo lung perfusion (EVLP', 'specific NLRP3 inflammasome inhibitor or control', 'Pro', 'Interleukin-1β (IL-1β', 'EVLP', 'IL-1β']","['lung function, hemodynamics, or inflammation', 'pro-IL-1β and caspase-1']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0524360', 'cui_str': 'Donor for lung transplant'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2936529', 'cui_str': 'Inflammasome'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0534519', 'cui_str': 'Caspase-1'}]",20.0,0.0339542,"Within the porcine EVLP, NLRP3 inflammasome inhibition reduced IL-1β within the perfusate compared to controls, but this had no impact on lung function, hemodynamics, or inflammation.
","[{'ForeName': 'Triin', 'Initials': 'T', 'LastName': 'Major', 'Affiliation': 'The Transplant Centre, University Hospital of South Manchester, Manchester, M23 9LT, United Kingdom.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Ball', 'Affiliation': 'The Transplant Centre, University Hospital of South Manchester, Manchester, M23 9LT, United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Stone', 'Affiliation': 'The Transplant Centre, University Hospital of South Manchester, Manchester, M23 9LT, United Kingdom.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Edge', 'Affiliation': 'The Transplant Centre, University Hospital of South Manchester, Manchester, M23 9LT, United Kingdom.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Lopez-Castejon', 'Affiliation': 'Lydia Becker Institute of Immunology and Inflammation, Division of Inflammation, Immunity and Respiratory Medicine, University of Manchester, Manchester, M13 9NT, United Kingdom.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Sjöberg', 'Affiliation': 'Department of Cardiothoracic Surgery, Lund University and Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Andreasson', 'Affiliation': 'Institute of Transplantation, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, NE7 7DN, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brough', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, AV Hill Building, Oxford Road, Manchester M13 9PT, United Kingdom.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Steen', 'Affiliation': 'Department of Cardiothoracic Surgery, Lund University and Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Fisher', 'Affiliation': 'Institute of Transplantation, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, NE7 7DN, United Kingdom.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Fildes', 'Affiliation': 'The Transplant Centre, University Hospital of South Manchester, Manchester, M23 9LT, United Kingdom.'}]",Transplantation,['10.1097/TP.0000000000003463']
3044,32976501,"The impact of Worms and Ladders, an innovative health educational board game on Soil-Transmitted Helminthiasis control in Abeokuta, Southwest Nigeria.","In most endemic sub-Saharan African countries, repeated infections with soil-transmitted helminth (STH) occur as early as six weeks after the end of mass drug administration (MDA) with albendazole. In this study, we designed a new health educational board game Worms and Ladders and evaluated its potential to complement MDA with albendazole and reduce reinfection rates through the promotion of good hygiene practices among school-aged children. The evaluation employed a randomized control trial (RCT) design. Baseline knowledge, attitude and practices (KAP) relating to STH were obtained using a questionnaire from 372 pupils across six schools in Abeokuta, Nigeria. Schools were randomly assigned into intervention and control group, with the former and latter receiving Worms and Ladders and the common Snake and Ladder board game respectively. Fresh stool samples were also collected at baseline for STH diagnosis before administering 400mg single dose albendazole. Follow-up assessments of STH burden and KAP were conducted three and six months' post-intervention. Data generated from the study were analyzed using SPSS 20.0 software, with confidence interval set at 95%. Prevalence of STH dropped from 25.0% to 10.4% in the intervention group and 49.4% to 33.3% in the control group at three months' post-intervention. The prevalence further dropped to 5.6% in the intervention group at six months' post-intervention. However, it increased to 37.2% in the control group at six months' post-intervention. There was a significant difference (p<0.05) in prevalence after intervention among the groups. KAP on transmission, control and prevention of STH significantly improved (p<0.05) from 5.2% to 97.9% in the intervention group compared to 6.2% to 7.1% in the control group. The Worms and Ladders board game shows the potential to teach and promote good hygiene behavior among SAC. These findings posit the newly developed game as a reliable tool to complement mass drug administration campaigns for STH control.",2020,"KAP on transmission, control and prevention of STH significantly improved (p<0.05) from 5.2% to 97.9% in the intervention group compared to 6.2% to 7.1% in the control group.","['Soil-Transmitted Helminthiasis control in Abeokuta, Southwest Nigeria', 'school-aged children', '372 pupils across six schools in Abeokuta, Nigeria']","['albendazole', 'KAP']","['transmission, control and prevention of STH', 'Baseline knowledge, attitude and practices (KAP', 'Prevalence of STH', 'reinfection rates']","[{'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0018889', 'cui_str': 'Helminth infection'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0242781', 'cui_str': 'Communicable Disease Transmission'}, {'cui': 'C0018893', 'cui_str': 'Helminth'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205339', 'cui_str': 'Reinfection'}]",,0.043445,"KAP on transmission, control and prevention of STH significantly improved (p<0.05) from 5.2% to 97.9% in the intervention group compared to 6.2% to 7.1% in the control group.","[{'ForeName': 'Dorcas B', 'Initials': 'DB', 'LastName': 'Bassey', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Hammed O', 'Initials': 'HO', 'LastName': 'Mogaji', 'Affiliation': 'Department of Animal and Environmental Biology, Federal University Oye-Ekiti, Ekiti State, Nigeria.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Dedeke', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Bolanle I', 'Initials': 'BI', 'LastName': 'Akeredolu-Ale', 'Affiliation': 'Department of Communication and General Studies, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Eniola M', 'Initials': 'EM', 'LastName': 'Abe', 'Affiliation': ""National Institute of Parasitic Disease and Control, China Centre for Disease Control, People's Republic of China.""}, {'ForeName': 'Akinola S', 'Initials': 'AS', 'LastName': 'Oluwole', 'Affiliation': 'COUNTDOWN project, Sightsavers, Nigeria Country Office, Nigeria.'}, {'ForeName': 'Abdulhakeem A', 'Initials': 'AA', 'LastName': 'Adeniran', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Olagunju A', 'Initials': 'OA', 'LastName': 'Agboola', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}, {'ForeName': 'Chiedu F', 'Initials': 'CF', 'LastName': 'Mafiana', 'Affiliation': 'Directorate of Research and Innovation, National Open University of Nigeria, Abuja, Nigeria.'}, {'ForeName': 'Uwem F', 'Initials': 'UF', 'LastName': 'Ekpo', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Ogun State, Nigeria.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008486']
3045,32976660,"Effect of preoperative oral administration of steroids in comparison to an anti-inflammatory drug on postoperative pain following single-visit root canal treatment - a double-blind, randomized clinical trial.","AIM


This randomized, double blinded, clinical trial evaluated the effect of oral premedication of piroxicam, prednisolone, dexamethasone or placebo on postoperative pain after single-visit root canal treatment in teeth with symptomatic irreversible pulpitis and symptomatic apical periodontitis.
METHODOLOGY


The trial is reported according to the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines. The protocol was registered at the clinical trial registry (India) (CTRI/2019/06/019818). In total, 160 patients, assigned to four groups, received orally either 20 mg piroxicam, 20 mg prednisolone, 4 mg dexamethasone or a placebo 60 minutes before root canal treatment. Patients recorded their postoperative pain intensity at 6h, 12h, 24h, 48h and, 72h using a 10-cm Visual Analogue Scale. Intergroup comparison was performed using Kruskal-Wallis tests with post Hoc analysis using Dunns Test. Incidence of pain was analyzed using Chi Square tests. A p value < 0.05 was considered to be statistically significant. Binary logistic regression was used to determine the odds of postoperative pain, with incidence of pain as the dependent variable and intervention groups, gender, age and type of tooth as independent variables.
RESULTS


In total, 156 patients were analyzed in the trial, since four patients dropped out during follow-up. All drugs were associated with a significantly lower incidence of postoperative pain compared to the placebo at 6h (p=0.009), 12h (p=0.003) and 24h (p=0.008). Mean intensity of pain was significantly more intense at 6h, 12h and 24h with the use of placebo in comparison to the other three intervention groups (p < 0.05). Intensity of pain was not significantly different between the premedications used (p > 0.05). One patient, in the piroxicam group reported gastritis, whereas no adverse effects were recorded in other groups.
CONCLUSION


Preoperative oral administration of a single dose of 4 mg dexamethasone, 20 mg piroxicam or 20 mg prednisolone reduced the incidence and severity of postoperative pain following single-visit root canal treatment compared to a placebo in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis up to 24h. The odds of postoperative pain at 24h for patients premedicated with 4 mg dexamethasone or 20 mg piroxicam or 20 mg prednisolone was 5.3 times, 3.4 times and 2.5 times less compared to the placebo respectively.",2020,"Mean intensity of pain was significantly more intense at 6h, 12h and 24h with the use of placebo in comparison to the other three intervention groups (p < 0.05).","['patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis', '160 patients', 'teeth with symptomatic irreversible pulpitis and symptomatic apical periodontitis']","['piroxicam', 'steroids', 'dexamethasone', 'piroxicam, prednisolone, dexamethasone or placebo', 'placebo', 'prednisolone, 4 mg dexamethasone or a placebo', 'prednisolone']","['postoperative pain intensity', 'incidence and severity of postoperative pain', 'Intensity of pain', 'adverse effects', 'Incidence of pain', 'gastritis', 'Mean intensity of pain', '10-cm Visual Analogue Scale', 'postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0017152', 'cui_str': 'Gastritis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",156.0,0.444715,"Mean intensity of pain was significantly more intense at 6h, 12h and 24h with the use of placebo in comparison to the other three intervention groups (p < 0.05).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Suresh', 'Affiliation': 'Faculty of Dental sciences, Meenakshi Ammal Higher Education and Research, Chennai, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Nagendrababu', 'Affiliation': 'Division of Clinical Dentistry, School of Dentistry, International Medical University, Kuala Lumpur, Malaysia.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Koteeswaran', 'Affiliation': 'Faculty of Dental sciences, Meenakshi Ammal Higher Education and Research, Chennai, India.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Haritha', 'Affiliation': 'Faculty of Dental sciences, Meenakshi Ammal Higher Education and Research, Chennai, India.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Swetha', 'Affiliation': 'Faculty of Dental sciences, Meenakshi Ammal Higher Education and Research, Chennai, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Varghese', 'Affiliation': 'Faculty of Dental sciences, Meenakshi Ammal Higher Education and Research, Chennai, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Natanasabapathy', 'Affiliation': 'Faculty of Dental sciences, Meenakshi Ammal Higher Education and Research, Chennai, India.'}]",International endodontic journal,['10.1111/iej.13416']
3046,32976702,Simultaneous robotic kidney transplantation and bariatric surgery for morbidly obese patients with end-stage renal failure.,"Patients with obesity have limited access to kidney transplantation, mainly due to an increased incidence of surgical complications, which could be reduced with selective use of robotic-assisted surgery. This prospective randomized controlled trial compares the safety and efficacy of combining robotic sleeve gastrectomy and robotic-assisted kidney transplant to robotic kidney transplant alone in candidates with class II or III obesity. Twenty candidates were recruited, 11 were randomized to the robotic sleeve gastrectomy and robotic-assisted kidney transplant group and 9 to the robotic kidney transplant group. At 12-month follow-up, change in body mass index was -8.76±1.82 in the robotic sleeve gastrectomy and robotic-assisted kidney transplant group compared to 1.70±2.30 in the robotic kidney transplant group (P=0.0041). Estimated glomerular filtration rate, serum creatinine, readmission rates, and graft failure rates up to 12 months were not different between the two groups. Length of surgery was longer in the robotic sleeve gastrectomy and robotic-assisted kidney transplant group (405 minutes versus 269 minutes, P=0.00304) without increase in estimated blood loss (120 ml versus 117 ml, P=0.908) or incidence of surgical complications. Combined robotic-assisted kidney transplant and sleeve gastrectomy is safe and effective compared to robotic-assisted kidney transplant alone.",2020,Combined robotic-assisted kidney transplant and sleeve gastrectomy is safe and effective compared to robotic-assisted kidney transplant alone.,"['candidates with class II or III obesity', 'Twenty candidates were recruited, 11 were randomized to the', 'morbidly obese patients with end-stage renal failure', 'Patients with obesity']","['robotic sleeve gastrectomy and robotic-assisted kidney transplant group and 9 to the robotic kidney transplant group', 'robotic sleeve gastrectomy and robotic-assisted kidney transplant', 'robotic sleeve gastrectomy and robotic-assisted kidney transplant to robotic kidney transplant alone', 'Combined robotic-assisted kidney transplant and sleeve gastrectomy', 'Simultaneous robotic kidney transplantation and bariatric surgery']","['body mass index', 'safety and efficacy', 'Length of surgery', 'estimated blood loss', 'Estimated glomerular filtration rate, serum creatinine, readmission rates, and graft failure rates', 'incidence of surgical complications']","[{'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",20.0,0.0243487,Combined robotic-assisted kidney transplant and sleeve gastrectomy is safe and effective compared to robotic-assisted kidney transplant alone.,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Spaggiari', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Di Cocco', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}, {'ForeName': 'Kiara', 'Initials': 'K', 'LastName': 'Tulla', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}, {'ForeName': 'Kerim B', 'Initials': 'KB', 'LastName': 'Kaylan', 'Affiliation': 'College of Medicine, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Masrur', 'Affiliation': 'Division of General, Minimally Invasive, & Robotic Surgery, Department of Surgery, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}, {'ForeName': 'Chandra', 'Initials': 'C', 'LastName': 'Hassan', 'Affiliation': 'Division of General, Minimally Invasive, & Robotic Surgery, Department of Surgery, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Almario Alvarez', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Benedetti', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Tzvetanov', 'Affiliation': 'Division of Transplantation, Department of Surgery, University of Illinois at Chicago, Chicago, IL, 60612, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16322']
3047,32976844,Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs. Stance Control vs. Locked KAFO: A Randomized Control Trial.,"OBJECTIVE


To evaluate the potential of a microprocessor swing and stance controlled knee-ankle-foot orthosis (MPO) to improve balance, functional mobility, and quality of life in individuals with lower-extremity impairments as compared to a stance-control-orthosis (SCO) and conventional knee-ankle-foot orthosis (KAFO) over a use-period of a month.
DESIGN


Randomized crossover study.
SETTING


Ambulatory research lab and home and community for community dwelling adults.
PARTICIPANTS


Eighteen persons who actively use a unilateral KAFO or SCO for impairments due to neurological or neuromuscular disease, orthopedic disease, or trauma.
INTERVENTION


Participants were trained to acclimate and use SCO and MPO.
MAIN OUTCOME MEASURES


6 Minute Walk Test (6MWT), 10 Meter Walk Test (10MWT), Berg Balance Scale (BBS), Functional Gait Assessment (FGA), Hill Assessment Index (HAI), Stair Assessment Index (SAI), 5 Times Sit to Stand Test (5xSST), Cross Walk Test, Modified Falls Efficacy Scale (mFES), Orthotic and Prosthetic User's Survey (OPUS), World Health Organization Quality of Life - Brief Scale (WHOQOL-BREF).
RESULTS


Significant changes were observed in participants' self-selected gait speed (p=0.023), BBS (p=0.01), FGA (p=0.002), and SAI (p<0.001) between baseline and Post MPO assessment. Similar significant differences were seen when comparing Post MPO with Post SCO data. During the 6MWT, persons using the MPO walked significantly longer (p=0.013) than when using their baseline device. Participants reported higher quality of life scores in the OPUS (p=0.02) and physical health domain of the WHOQOL-BREF (p=0.037) after using the MPO. Participants reported fewer falls when wearing the MPO (5) versus an SCO (38) or locked KAFO (15).
CONCLUSIONS


The MPO may contribute to improved quality of life and health status of persons with lower-extremity impairments by providing the ability to have better walking speed, endurance, and functional balance.",2020,Participants reported higher quality of life scores in the OPUS (p=0.02) and physical health domain of the WHOQOL-BREF (p=0.037) after using the MPO.,"['individuals with lower-extremity impairments', 'Eighteen persons who actively use a unilateral KAFO or SCO for impairments due to neurological or neuromuscular disease, orthopedic disease, or trauma', 'Ambulatory research lab and home and community for community dwelling adults']","['stance-control-orthosis (SCO) and conventional knee-ankle-foot orthosis (KAFO', 'microprocessor swing and stance controlled knee-ankle-foot orthosis (MPO', 'Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs. Stance Control vs. Locked KAFO']","['6 Minute Walk Test (6MWT), 10 Meter Walk Test (10MWT), Berg Balance Scale (BBS), Functional Gait Assessment (FGA), Hill Assessment Index (HAI), Stair Assessment Index (SAI', 'balance, functional mobility, and quality of life', 'physical health domain of the WHOQOL-BREF', ""participants' self-selected gait speed"", ""5 Times Sit to Stand Test (5xSST), Cross Walk Test, Modified Falls Efficacy Scale (mFES), Orthotic and Prosthetic User's Survey (OPUS), World Health Organization Quality of Life - Brief Scale (WHOQOL-BREF"", 'quality of life and health status', 'quality of life scores', 'BBS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0438868', 'cui_str': 'Knee-ankle-foot orthosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0438868', 'cui_str': 'Knee-ankle-foot orthosis'}, {'cui': 'C0026012', 'cui_str': 'Microprocessors'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0231753', 'cui_str': 'Knee locking'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1283250', 'cui_str': 'Foot orthosis'}]","[{'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0442532', 'cui_str': 'Hill'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.040921,Participants reported higher quality of life scores in the OPUS (p=0.02) and physical health domain of the WHOQOL-BREF (p=0.037) after using the MPO.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Deems-Dluhy', 'Affiliation': 'Max Näder Lab for Rehabilitation Technologies & Outcomes Lab, Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago), Chicago, IL; Center for Bionic Medicine, Shirley Ryan AbilityLab, Chicago, IL.'}, {'ForeName': 'Shenan', 'Initials': 'S', 'LastName': 'Hoppe-Ludwig', 'Affiliation': 'Max Näder Lab for Rehabilitation Technologies & Outcomes Lab, Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago), Chicago, IL; Center for Bionic Medicine, Shirley Ryan AbilityLab, Chicago, IL.'}, {'ForeName': 'Chaithanya K', 'Initials': 'CK', 'LastName': 'Mummidisetty', 'Affiliation': 'Max Näder Lab for Rehabilitation Technologies & Outcomes Lab, Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago), Chicago, IL; Center for Bionic Medicine, Shirley Ryan AbilityLab, Chicago, IL.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Semik', 'Affiliation': 'Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Chicago, IL.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Heinemann', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University, Chicago, IL; Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, Chicago, IL.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Jayaraman', 'Affiliation': 'Max Näder Lab for Rehabilitation Technologies & Outcomes Lab, Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago), Chicago, IL; Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University, Chicago, IL; Center for Bionic Medicine, Shirley Ryan AbilityLab, Chicago, IL. Electronic address: ajayaraman@sralab.org.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.08.013']
3048,32976869,Phase 1 trial of ralimetinib (LY2228820) with radiotherapy plus concomitant temozolomide in the treatment of newly diagnosed glioblastoma.,"BACKGROUND AND PURPOSE


This phase 1 trial aimed to determine the maximum tolerated dose (MTD; primary objective) of a p38-MAPK inhibitor, ralimetinib, with radiotherapy (RT) and chemotherapy (TMZ), in the treatment of newly diagnosed glioblastoma (GBM) patients.
MATERIALS AND METHODS


The study was designed as an open-label dose-escalation study driven by a Tite-CRM design and followed by an expansion cohort. Ralimetinib was administered orally every 12 hours, 7 days a week, for 2 cycles of 2 weeks at a dose of 100, 200 or 300 mg/12h. Patients received ralimetinib added to standard concurrent RT (60 Gy in 30 fractions) with TMZ (75 mg/m 2 /day) and 6 cycles of adjuvant TMZ (150 to 200 mg/m 2  on days 1 to 5 every 28 days).
RESULTS


The MTD of ralimetinib was 100 mg/12h with chemoradiotherapy. The three patients treated at 200 mg/12h presented a dose-limiting toxicity: one patient had a grade 3 face edema, and two patients had a grade 3 rash and grade 3 hepatic cytolysis (66%). Of the 18 enrolled patients, 15 received the MTD of ralimetinib. At the MTD, the grade ≥ 3 adverse events during concomitant chemoradiotherapy were hepatic cytolysis (2/15 patients), dermatitis/rash (1/15), lymphopenia (1/15) and nausea/vomiting (1/15). No interaction of TMZ and ralimetinib when administrated concomitantly has been observed. Inhibition of pMAPKAP-K2 (-54%) was observed in peripheral blood mononuclear cells.
CONCLUSION


This phase 1 trial is the first trial to study the combination of a p38-MAPK inhibitor, ralimetinib, with radiotherapy (RT) and chemotherapy (TMZ), in the treatment of newly diagnosed glioblastoma (GBM) patients. The MTD of ralimetinib was 100 mg/12h. The most frequent dose-limiting toxicities were hepatic cytolysis and rash.",2020,No interaction of TMZ and ralimetinib when administrated concomitantly has been observed.,"['18 enrolled patients, 15 received the MTD of ralimetinib', 'newly diagnosed glioblastoma', 'newly diagnosed glioblastoma (GBM) patients']","['adjuvant TMZ', 'TMZ', 'ralimetinib added to standard concurrent RT', 'Ralimetinib', 'p38-MAPK inhibitor, ralimetinib, with radiotherapy (RT) and chemotherapy (TMZ', 'ralimetinib (LY2228820) with radiotherapy plus concomitant temozolomide']","['peripheral blood mononuclear cells', 'lymphopenia (1/15) and nausea/vomiting', 'dermatitis/rash', 'grade 3 rash and grade 3 hepatic cytolysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0257535', 'cui_str': 'CSAID-Binding Protein'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0151763', 'cui_str': 'Liver damage'}]",18.0,0.0623238,No interaction of TMZ and ralimetinib when administrated concomitantly has been observed.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Biau', 'Affiliation': 'Radiation department, Centre Jean Perrin, Clermont-Ferrand, F-63011, France; University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, FR-63000, France. Electronic address: Julian.biau@clermont.unicancer.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Thivatx', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, FR-63000, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, F 63001, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chautard', 'Affiliation': 'University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; Department of clinical research, Délégation Recherche Clinique et Innovation, Centre Jean Perrin, F-63011 Clermont-Ferrand, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stefan', 'Affiliation': 'Pathology department, Centre Jean Perrin, Clermont-Ferrand, France. F-63011, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boone', 'Affiliation': 'Radiation oncology department, Centre François Baclesse, F-14076, Caen, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chauffert', 'Affiliation': 'Radiation oncology department, Centre François Baclesse, F-14076, Caen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bourgne', 'Affiliation': 'Department of Medical oncology, CHU Amiens, 80054, Amiens Cedex 1, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Richard', 'Affiliation': 'Department of Biologic hematology, CHU Estaing, 63003 Clermont-Ferrand Cedex 1, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Molna', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, FR-63000, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, F 63001, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Levesque', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, FR-63000, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, F 63001, France.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bellini', 'Affiliation': 'CHU Clermont-Ferrand, University of Clermont-Auvergne, Medical Pharmacology department, UMR INSERM, 1107 Neuro-Dol, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kwiatkowski', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, FR-63000, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, F 63001, France.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Karayan-Tapon', 'Affiliation': 'Radiodiagnostic Department, Centre Jean-Perrin, Clermont-Ferrand, France. F-63011, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Verrelle', 'Affiliation': 'Radiation department, Centre Jean Perrin, Clermont-Ferrand, F-63011, France; University of Poitiers, INSERMU1084, CHU de Poitiers, Department of Cancer Biology, 86021 Poitiers, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Godfraind', 'Affiliation': 'Department of Radiation Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Durando', 'Affiliation': ""University of Clermont Auvergne, UFR Médecine, Clermont-Ferrand, France; INSERM U1240 IMoST, University of Clermont Auvergne, Clermont-Ferrand, FR-63000, France; Centre d'Investigation Clinique UMR 501, Clermont-Ferrand, F 63001, France; Department of Pathological Anatomy, CHU de Clermont-Ferrand, Clermont-Ferrand, France.""}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.036']
3049,32977137,Therapeutic versus prophylactic anticoagulation for severe COVID-19: A randomized phase II clinical trial (HESACOVID).,"INTRODUCTION


Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state. Several autopsy studies have found microthrombi in pulmonary circulation.
METHODS


In this randomized, open-label, phase II study, we randomized COVID-19 patients requiring mechanical ventilation to receive either therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis. We evaluated the gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, 7, and 14 days after randomization, the time until successful liberation from mechanical ventilation, and the ventilator-free days.
RESULTS


Ten patients were assigned to the therapeutic enoxaparin and ten patients to prophylactic anticoagulation. There was a statistically significant increase in the PaO2/FiO2 ratio over time in the therapeutic group (163 [95% confidence interval - CI 133-193] at baseline, 209 [95% CI 171-247] after 7 days, and 261 [95% CI 230-293] after 14 days), p = 0.0004. In contrast, we did not observe this improvement over time in the prophylactic group (184 [95% CI 146-222] at baseline, 168 [95% CI 142-195] after 7 days, and 195 [95% CI 128-262] after 14 days), p = 0.487. Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = 0.031 and more ventilator-free days (15 days [interquartile range IQR 6-16] versus 0 days [IQR 0-11]), p = 0.028 when compared to the prophylactic group.
CONCLUSION


Therapeutic enoxaparin improves gas exchange and decreases the need for mechanical ventilation in severe COVID-19.
TRIAL REGISTRATION


REBEC RBR-949z6v.",2020,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","['COVID-19 patients requiring mechanical ventilation to receive either', 'severe COVID-19']","['Therapeutic versus prophylactic anticoagulation', 'enoxaparin', 'prophylactic anticoagulation', 'therapeutic enoxaparin', 'therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis']","['PaO2/FiO2 ratio', 'higher ratio of successful liberation from mechanical ventilation', 'gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",10.0,0.230806,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","[{'ForeName': 'Anna Cristina Bertoldi', 'Initials': 'ACB', 'LastName': 'Lemos', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Douglas Alexandre', 'Initials': 'DA', 'LastName': 'do Espírito Santo', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Maísa Cabetti', 'Initials': 'MC', 'LastName': 'Salvetti', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Renato Noffs', 'Initials': 'RN', 'LastName': 'Gilio', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Lucas Barbosa', 'Initials': 'LB', 'LastName': 'Agra', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pazin-Filho', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Miranda', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil. Electronic address: chmiranda@fmrp.usp.br.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.026']
3050,32977202,The differential impact of viewing fitspiration and thinspiration images on men's body image concerns: An experimental ecological momentary assessment study.,"To date, little is known about the impact of fitspiration and thinspiration exposure on men, as previous studies on these social media trends were primarily conducted on women. Male participants (n = 223) completed baseline measures of trait body image, then used a smartphone application to complete up to six state-based assessments daily for seven days. In each assessment, participants were randomly assigned to one of three image conditions (fitspiration, thinspiration, or neutral). Before and after viewing each image, they reported state body fat dissatisfaction, muscularity dissatisfaction, negative mood, and urge to engage in behaviours to reduce body fat and increase muscularity. Multi-level analyses revealed that compared to viewing neutral images, viewing fitspiration images increased men's body dissatisfaction, whereas viewing thinspiration images decreased body dissatisfaction. Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat. Men with greater baseline muscularity dissatisfaction and higher appearance comparison were most vulnerable to muscularity dissatisfaction after viewing fitspiration images. Findings suggest the importance of limiting exposure to fitspiration imagery and implementing social media literacy programmes for men and well as women.",2020,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","['men and well as women', 'Male participants (n = 223', ""men's body image concerns""]",['viewing fitspiration and thinspiration images'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",[],223.0,0.019817,"Viewing either fit- or thinspiration images also led to lower mood and greater urges to increase muscularity, whereas only fitspiration images increased urges to reduce body fat.","[{'ForeName': 'Zhi Wei', 'Initials': 'ZW', 'LastName': 'Yee', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: zhiwei@student.unimelb.edu.au.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: scott.griffiths@unimelb.edu.au.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'Centre for Social and Early Emotional Development, School of Psychology, Deakin University, Burwood, VIC, 3125, Australia; School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: matthew.fuller.tyszkiewicz@deakin.edu.au.'}, {'ForeName': 'Khandis', 'Initials': 'K', 'LastName': 'Blake', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: khandis.blake@unimelb.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'School of Psychology, Deakin University, Burwood, VIC, 3125, Australia. Electronic address: Ben.Richardson@nousgroup.com.au.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Krug', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Redmond Barry Building, Melbourne, VIC, 3010, Australia. Electronic address: Isabel.krug@unimelb.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.08.008']
3051,32977212,Behavioral and electrophysiological effects of network-based frontoparietal tDCS in patients with severe brain injury: A randomized controlled trial.,"BACKGROUND


Transcranial direct current stimulation (tDCS) may promote the recovery of severely brain-injured patients with disorders of consciousness (DOC). Prior tDCS studies targeted single brain regions rather than brain networks critical for consciousness recovery.
OBJECTIVE


Investigate the behavioral and electrophysiological effects of multifocal tDCS applied over the frontoparietal external awareness network in patients with chronic acquired DOC.
METHODS


Forty-six patients were included in this randomized double-blind sham-controlled crossover trial (median [interquartile range]: 46 [35 - 59] years old; 12 [5 - 47] months post injury; 17 unresponsive wakefulness syndrome, 23 minimally conscious state (MCS) and 6 emerged from the MCS). Multifocal tDCS was applied for 20 min using 4 anodes and 4 cathodes with 1 mA per electrode. Coma Recovery Scale-Revised (CRS-R) assessment and 10 min of resting state electroencephalogram (EEG) recordings were acquired before and after the active and sham sessions.
RESULTS


At the group level, there was no tDCS behavioral treatment effect. However, following active tDCS, the EEG complexity significantly increased in low frequency bands (1-8 Hz). CRS-R total score improvement was associated with decreased baseline complexity in those bands. At the individual level, after active tDCS, new behaviors consistent with conscious awareness emerged in 5 patients. Conversely, 3 patients lost behaviors consistent with conscious awareness.
CONCLUSION


The behavioral effect of multifocal frontoparietal tDCS varies across patients with DOC. Electrophysiological changes were observed in low frequency bands but not translated into behavioral changes at the group level.",2020,"At the group level, there was no tDCS behavioral treatment effect.","['severely brain-injured patients with disorders of consciousness (DOC', 'patients with severe brain injury', 'Forty-six patients', 'patients with chronic acquired DOC', 'patients with DOC']","['multifocal tDCS', 'network-based frontoparietal tDCS', 'Transcranial direct current stimulation (tDCS', 'minimally conscious state (MCS) and 6 emerged from the MCS']","['EEG complexity', 'CRS-R total score improvement', 'Electrophysiological changes', 'Coma Recovery Scale-Revised (CRS-R) assessment and 10\xa0min of resting state electroencephalogram (EEG) recordings']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009792', 'cui_str': 'Consciousness Disorders'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]","[{'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0751699', 'cui_str': 'Minimally conscious state'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",46.0,0.240193,"At the group level, there was no tDCS behavioral treatment effect.","[{'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Martens', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium. Electronic address: geraldine.martens@uliege.be.""}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kroupi', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Bodien', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA; Laboratory for Neuroimaging in Coma and Consciousness, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Frasso', 'Affiliation': 'Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jitka', 'Initials': 'J', 'LastName': 'Annen', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Cassol', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Barra', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Martial', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Gosseries', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Lejeune', 'Affiliation': 'Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre Hospitalier Neurologique William Lennox, Saint-Luc University Clinics, Université Catholique de Louvain, Belgium.'}, {'ForeName': 'Aureli', 'Initials': 'A', 'LastName': 'Soria-Frisch', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Laureys', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium.""}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Thibaut', 'Affiliation': ""Coma Science Group, GIGA Consciousness, University of Liège, Liège, Belgium; Centre du Cerveau2 - Centre intégré pluridisciplinaire de l'étude du cerveau, de la cognition et de la conscience, University Hospital of Liège, Liège, Belgium; Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102426']
3052,32977220,Phase I/II trial of sequential treatment of nab-paclitaxel in combination with gemcitabine followed by modified FOLFOX chemotherapy in patients with untreated metastatic exocrine pancreatic cancer: Phase I results.,"BACKGROUND


Although occasioned through different mechanisms, the potential neurotoxicity and also haematological toxicity of nab-paclitaxel and oxaliplatin-based chemotherapy regimen were studied in this trial, which aimed to determine the maximum-tolerated dose (MTD) and to evaluate safety and efficacy of the combination in a sequential regimen of nab-paclitaxel, gemcitabine (GEM) and modified FOLFOX (mFOLFOX) in untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
MATERIALS AND METHODS


Treatment consisted of nab-paclitaxel (125/100 mg/m 2 ) plus GEM (1000/800 mg/m 2 ) on days 1, 8 and 15, followed by mFOLFOX (oxaliplatin [85/75/65 mg/m 2 ], 5-FU bolus [400/300/200 mg/m 2 ], 5-FU infusion [2400/2000/1600 mg/m 2 ]) on day 28, of a 42-day cycle. Patients were enrolled at the highest dose level with a subsequent 3 + 3 dose de-escalation plan.
RESULTS


Eleven patients (median age = 61, 64% with performance status [PS] = 1) were eligible. All patients received the highest dose level. No de-escalation was needed. A dose-limiting toxicity was reported, an upper gastrointestinal haemorrhage. The MTD was nab-paclitaxel 125 mg/m 2 , GEM 1000 mg/m 2 , oxaliplatin 85 mg/m 2 , 5-FU bolus 400 mg/m 2  and 5-FU infusion 2400 mg/m 2 . Common all-grade toxicities were neutropenia (73%), anaemia (55%), thrombocytopenia (55%) and asthenia (55%). Other relevant toxicities were paraesthesia (46%), nausea (36%), dysesthesia (27%) and pyrexia (27%). Objective response rate was 50% and disease control rate was 80%.
CONCLUSIONS


The regimen of nab-paclitaxel plus GEM followed by mFOLFOX showed favourable safety and tolerability profiles with significant anti-tumor activity. More data are being achieved in a randomised phase II trial, to confirm efficacy rates and dismiss long-term neurotoxicity concerns regarding the sequencing of nab-paclitaxel and oxaliplatin.",2020,No de-escalation was needed.,"['untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC', 'patients with untreated metastatic exocrine pancreatic cancer', 'Eleven patients (median age\xa0=\xa061, 64% with performance status [PS]\xa0=\xa01) were eligible']","['gemcitabine followed by modified FOLFOX chemotherapy', '5-FU infusion 2400', 'nab-paclitaxel', 'paclitaxel', 'paclitaxel and oxaliplatin-based chemotherapy', 'oxaliplatin', 'oxaliplatin 85\xa0mg/m 2 , 5-FU bolus 400', 'nab-paclitaxel plus GEM', 'mFOLFOX (oxaliplatin [85/75/65\xa0mg/m 2 ], 5-FU bolus [400/300/200\xa0mg/m 2 ], 5-FU infusion', 'nab-paclitaxel, gemcitabine (GEM) and modified FOLFOX (mFOLFOX', 'nab-paclitaxel (125/100\xa0mg/m 2 ) plus GEM']","['disease control rate', 'favourable safety and tolerability profiles', 'thrombocytopenia', 'asthenia', 'nausea', 'Objective response rate', 'neutropenia', 'anaemia', 'pyrexia']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0346648', 'cui_str': 'Malignant tumor of exocrine pancreas'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",1.0,0.0271254,No de-escalation was needed.,"[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Carrato', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; University of Alcalá. Alcalá de Henares, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain; CIBERONC, Madrid. Spain. Electronic address: acarrato@telefonica.net.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Vieitez', 'Affiliation': 'University Central Hospital of Asturias, Oviedo. Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Benavides', 'Affiliation': 'University Regional Hospital and Virgen de la Victoria, Málaga. Spain; IBIMA, Málaga. Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Rodriguez-Garrote', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain; CIBERONC, Madrid. Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Castillo', 'Affiliation': 'University Central Hospital of Asturias, Oviedo. Spain.'}, {'ForeName': 'Gema Durán', 'Initials': 'GD', 'LastName': 'Ogalla', 'Affiliation': 'University Regional Hospital and Virgen de la Victoria, Málaga. Spain; IBIMA, Málaga. Spain.'}, {'ForeName': 'Laura García', 'Initials': 'LG', 'LastName': 'Bermejo', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; University of Alcalá. Alcalá de Henares, Madrid. Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Ruiz de Mena', 'Affiliation': 'Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD).'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Guillén-Ponce', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid. Spain; Ramon y Cajal Institute for Health Research (IRYCIS), Laboratory of Molecular Biology, Madrid. Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Aranda', 'Affiliation': 'CIBERONC, Madrid. Spain; IMIBIC, Córdoba. Spain; Reina Sofia University Hospital, Córdoba. Spain; University of Córdoba, Córdoba. Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.07.035']
3053,32979640,"Effect of exercise capacity on perception of dyspnea, psychological symptoms and quality of life in patients with chronic obstructive pulmonary disease.","BACKGROUND


The negative impact of COPD on patients is not only physical, but also social and psychological.
OBJECTIVES


To examine the effects of decreased exercise capacity on health outcomes in patients with COPD.
METHODS


516 COPD patients divided into four groups according to the six-minute walking distances. Perception of dyspnea, quality of life, psychological symptoms were compared between groups.
RESULTS


All the disease-specific quality of life scores of patients walking over 350 m were significantly better than other groups (p<0,001). Anxiety, depression and dyspnea scores were found to be lower (p<0.001) in all those walking over 350 m (p<0,001).
CONCLUSIONS


It has been observed that markers such as quality of life, anxiety and depression, which are known to be affected in COPD patients, progress better especially in patients walking over 350 m.",2020,"All the disease-specific quality of life scores of patients walking over 350 m were significantly better than other groups (p<0,001).","['patients with chronic obstructive pulmonary disease', 'patients with COPD', '516 COPD patients divided into four groups according to the six-minute walking distances']",['exercise capacity'],"['Perception of dyspnea, quality of life, psychological symptoms', 'health outcomes', 'Anxiety, depression and dyspnea scores', 'disease-specific quality of life scores', 'perception of dyspnea, psychological symptoms and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",516.0,0.0268225,"All the disease-specific quality of life scores of patients walking over 350 m were significantly better than other groups (p<0,001).","[{'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Hulya', 'Affiliation': 'Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital, Chest Diseases Clinic, Izmir, Turkey. Electronic address: drhdogan@yahoo.com.'}, {'ForeName': 'Naz', 'Initials': 'N', 'LastName': 'Ilknur', 'Affiliation': 'Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Izmir, Turkey.'}, {'ForeName': 'Polat', 'Initials': 'P', 'LastName': 'Gulru', 'Affiliation': 'Dr. Suat Seren Chest Diseases and Thoracic Surgery Training and Research Hospital, Chest Diseases Clinic, Izmir, Turkey.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.09.008']
3054,32979642,Incidence of immediate postextubation complications in critically Ill adult patients.,"BACKGROUND


Postextubation complication rates vary among studies. It is necessary to standardize a method to identify postextubation complications and determine their potential association with extubation failure and reintubation in critically ill adult patients.
OBJECTIVES


To describe immediate (up to 60 min) endotracheal postextubation complications in critically ill adult patients and determine whether these complications are associated with extubation failure.
METHODS


Secondary analysis of a Randomized Clinical Trial that included 240 critically ill adult patients, who were eligible for extubation. Overall complications include at least one major complication (upper airway obstruction, desaturation, vomiting, post-obstructive pulmonary edema) and/or minor complications (bronchospasm, severe cough, hypertension, tachycardia, tachypnea, poor respiratory mechanics).
RESULTS


Incidence of overall, major and minor complications was 71.2%, 30.9% and 62.7%, respectively. Forty (16.9%) patients failed extubation, and thirty (12.7%) were reintubated. Of 168 patients who developed a postextubation complication, 137 (81.5%) were successfully extubated. Only major complications were significantly associated with reintubation after extubation failure (p<0.001).
CONCLUSION


We have observed high incidence rates of overall, major and minor complications. The development of major complications was statistically significantly associated with extubation failure and reintubation. It is still unknown whether the identification and treatment of immediate postextubation complications have positive effects on patients' clinical course or whether the complications are a mere effect of the extubation procedure.",2020,"Only major complications were significantly associated with reintubation after extubation failure (p<0.001).
","['critically ill adult patients', '240 critically ill adult patients, who were eligible for extubation', '168 patients who developed a postextubation complication, 137 (81.5%) were successfully extubated', 'critically Ill adult patients']",[],"['major complication (upper airway obstruction, desaturation, vomiting, post-obstructive pulmonary edema) and/or minor complications (bronchospasm, severe cough, hypertension, tachycardia, tachypnea, poor respiratory mechanics', 'Incidence of overall, major and minor complications', 'Overall complications']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4517569', 'cui_str': '137'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0740852', 'cui_str': 'Upper airway obstruction'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",240.0,0.149797,"Only major complications were significantly associated with reintubation after extubation failure (p<0.001).
","[{'ForeName': 'Mauro Federico', 'Initials': 'MF', 'LastName': 'Andreu', 'Affiliation': 'Hospital Donación Francisco Santojanni, Autonomous City of Buenos Aires, Argentina; Universidad Nacional de la Matanza, San Justo, Province of Buenos Aires, Argentina. Electronic address: mfandreu@gmail.com.'}, {'ForeName': 'Marco Guillermo', 'Initials': 'MG', 'LastName': 'Bezzi', 'Affiliation': 'Hospital Donación Francisco Santojanni, Autonomous City of Buenos Aires, Argentina.'}, {'ForeName': 'María Eugenia', 'Initials': 'ME', 'LastName': 'Dotta', 'Affiliation': 'Hospital Donación Francisco Santojanni, Autonomous City of Buenos Aires, Argentina.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.09.016']
3055,32979646,Randomised controlled trial confirms benefit of enhanced recovery after surgery on length of stay in ovarian cancer: How low can we go?,,2020,,['ovarian cancer'],[],[],"[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]",[],[],,0.150722,,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Bisch', 'Affiliation': 'Division of Gynecologic Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Nelson', 'Affiliation': 'Division of Gynecologic Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada. Electronic address: gsnelson@ucalgary.ca.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.015']
3056,32979708,"The comparison of the effect of soybean and fish oil on supplementation on menopausal symptoms in postmenopausal women: A randomized, double-blind, placebo-controlled trial.","BACKGROUND


The effect of soybean and omega-3 fatty acid supplementation on menopausal symptoms in postmenopausal women was investigated.
MATERIALS AND METHODS


In a randomized, double-blind, placebo-controlled trial postmenopausal women were randomly given either soybean (Soygan 500 mg capsule; n = 60), or omega-3 fatty acids (Omega-rex 1000 mg soft gel; n = 60), or placebo (n = 60) daily for 12 weeks. The primary outcome was a change on the menopause rating scale score (MRS), while the secondary outcome was any adverse symptoms and effect was effect of soybean or omega-3 fatty acid supplements on the blood lipids and thyroid hormone.
RESULTS


Based on the results of post-hoc in terms of overall MRS score there was a significant difference between the control and Soygan (p < 0.001) and Omega-rex groups (p = 0.03); however, there was no significant difference between the two intervention groups (p = 0.86). Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
CONCLUSION


Soygan and Omega-rex reduced the MRS score and improved menopausal symptoms in postmenopausal women.",2020,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","['controlled trial postmenopausal women', 'postmenopausal women']","['soybean and omega-3 fatty acid supplementation', 'Omega-rex 1000\xa0mg soft gel; n\xa0=\xa060), or placebo', 'soybean or omega-3 fatty acid supplements', 'placebo', 'soybean and fish oil on supplementation', 'soybean (Soygan 500\xa0mg capsule; n\xa0=\xa060), or omega-3 fatty acids ']","['MRS score and improved menopausal symptoms', 'blood lipids and thyroid hormone', 'overall MRS score', 'menopausal symptoms', 'menopause rating scale score (MRS']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0324505', 'cui_str': 'Rex cat breed'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.663549,"Soygan and Omega-rex had no effects on the blood lipids and thyroid hormone.
","[{'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Purzand', 'Affiliation': 'School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Rokhgireh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran. Electronic address: s.rokhgireh@gmail.com.'}, {'ForeName': 'Mansoore', 'Initials': 'M', 'LastName': 'Shabani Zanjani', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Eshraghi', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Mahdiss', 'Initials': 'M', 'LastName': 'Mohamadianamiri', 'Affiliation': 'Department of Obstetrics & Gynecology, Iran University of Medical Sciences, Akbarabadi Teaching Hospital & National Association of Iranian Obstetricians & Gynecologists (NAIGO), Tehran, Iran.'}, {'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Esmailzadeh', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alkatout', 'Affiliation': 'Department of Obstetrics and Gynecology, Kiel School of Gynaecological Endoscopy, University Hospital Schleswig Holstein, Campus Kiel, Arnold-Heller-Str. 3, Haus C, 24105, Kiel, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Gitas', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of Schleswig Holstein, Luebeck, Germany.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Allahqoli', 'Affiliation': 'Endometriosis Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101239']
3057,32979880,Hepatitis C and HIV combined screening in primary care: a cluster randomized trial.,"Hepatitis C virus (HCV) and HIV are major causes of worldwide disease. We aimed to evaluate the effect of a combined screening program, which included a risk assessment questionnaire and rapid tests for point-of-care diagnosis, on screening and new diagnosis rates. This prospective, cluster randomized study was carried out in primary care. The intervention arm included a 4-hour educational program, the use of a risk-assessment questionnaire and rapid tests. In the control centers, only the educational intervention was provided. The main variables compared were the screening coverage and the number and rate of new HCV and HIV diagnoses. Of a total of 7,991 participants, 4,670 (58.5%) and 2,894 (36.2%) presented a risk questionnaire for HIV or HCV, respectively. The younger participants, men, and those from Latin America and Eastern Europe, showed the greatest risk of presenting with a positive questionnaire. The overall screening coverage was higher within the intervention arm (OR 17.7; 95% CI 16.2-19.5; p<0.001). Only two HIV-positives were identified compared to one in control centers. The rate of HCV diagnoses was higher among intervention centers, with 37 versus seven positive tests (OR 5.2; 95% CI 2.3-11.6; p<0.001). Of them, 10 were new diagnoses and 27 had been previously diagnosed, although not linked to care. In conclusion, a simple operational program can lead to an increase in HCV and HIV screening rates, compared to an exclusively educational program. The selection of at-risk patients with a self-questionnaire and the use of rapid tests significantly increased the diagnostic rate of HCV infection.",2020,The overall screening coverage was higher within the intervention arm (OR 17.7; 95% CI 16.2-19.5; p<0.001).,"['younger participants, men, and those from Latin America and Eastern Europe', 'primary care', 'Of a total of 7,991 participants, 4,670 (58.5%) and 2,894 (36.2%) presented a risk questionnaire for HIV or HCV, respectively']","['combined screening program', 'Hepatitis C and HIV combined screening', '4-hour educational program, the use of a risk-assessment questionnaire and rapid tests']","['HCV and HIV screening rates', 'overall screening coverage', 'diagnostic rate of HCV infection', 'rate of HCV diagnoses', 'screening coverage and the number and rate of new HCV and HIV diagnoses']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0015177', 'cui_str': 'East European country'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",7991.0,0.0568424,The overall screening coverage was higher within the intervention arm (OR 17.7; 95% CI 16.2-19.5; p<0.001).,"[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez Sanz', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Vivancos', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Sánchez-Conde', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gómez-Ayerbe', 'Affiliation': 'Hospital Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Polo', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Labrador', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'González', 'Affiliation': 'Servicio Madrileño de Salud, SUMMA, Madrid, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Mesa', 'Affiliation': 'Centro de Salud Avenida de Aragón, Madrid, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Muriel', 'Affiliation': 'Biostatistics Unit, Hospital Universitario Ramón y Cajal, IRYCIS, CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Chamorro', 'Affiliation': 'Centro de Salud Aquitania, Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'de la Fuente', 'Affiliation': 'Centro de Salud Aquitania, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Pérez Elías', 'Affiliation': 'Centro de Salud García Noblejas, Madrid, Spain.'}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Uranga', 'Affiliation': 'Centro de Salud García Noblejas, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Herrero', 'Affiliation': 'Centro de Salud Mar Báltico, Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ares', 'Affiliation': 'Centro de Salud Mar Báltico, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Barea', 'Affiliation': 'Centro de Salud Canal de Panamá, Madrid, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Moreno', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Pérez-Elías', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.'}]",Journal of viral hepatitis,['10.1111/jvh.13413']
3058,32979294,Pilot pragmatic randomized trial of mHealth mindfulness-based intervention for advanced cancer patients and their informal caregivers.,"OBJECTIVE


Assess the feasibility of conducting a cluster randomized trial (RCT) comparing technology-delivered mindfulness-based intervention (MBI) programs against a waitlist control arm targeting advanced cancer patients and their informal caregivers.
METHODS


Two-arm cluster RCT within Kaiser Permanente Northern California (KPNC). We recruited patients with metastatic solid malignancies or hematological cancers and their informal caregivers. Intervention-group participants chose to use either a commercially available mindfulness app (10-20 minutes/day) or a webinar-based mindfulness course for 6 weeks. The waitlist control group received usual care. We assessed feasibility measures and obtained participant-reported data on quality-of-life (primary outcome) and distress outcomes (secondary) pre- and post-intervention.
RESULTS


103 patients (median age 67 years; 70% female; 81% White) and 39 caregivers (median age 66 years; 79% female; 69% White) were enrolled. Nearly all participants chose the mindfulness app over the webinar-based program. Among the participants in the intervention arm who chose the mobile-app program and completed the postintervention (6-week) survey, 21 (68%) patients and 7 (47%) caregivers practiced mindfulness at least 50% of the days during the 6-week study period. Seventy-four percent of intervention participants were ""very"" or ""extremely"" satisfied with the mindfulness program. We observed improvements in anxiety, quality of life, and mindfulness among patients in the intervention arm compared to those in the control group.
CONCLUSIONS


We demonstrated the feasibility of conducting a cluster RCT of mHealth MBI for advanced cancer patients and their caregivers. Such remote interventions can be helpful particularly during the COVID-19 pandemic. This article is protected by copyright. All rights reserved.",2020,"We observed improvements in anxiety, quality of life, and mindfulness among patients in the intervention arm compared to those in the control group.
","['advanced cancer patients and their informal caregivers', 'Two-arm cluster RCT within Kaiser Permanente Northern California (KPNC', '103 patients (median age 67 years; 70% female; 81% White) and 39 caregivers (median age 66 years; 79% female; 69% White) were enrolled', 'patients with metastatic solid malignancies or hematological cancers and their informal caregivers', 'advanced cancer patients and their caregivers']","['mHealth mindfulness-based intervention', 'usual care', 'Intervention-group participants chose to use either a commercially available mindfulness app', 'technology-delivered mindfulness-based intervention (MBI) programs']","['anxiety, quality of life, and mindfulness', 'quality-of-life (primary outcome) and distress outcomes (secondary) pre- and post-intervention']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",103.0,0.0375436,"We observed improvements in anxiety, quality of life, and mindfulness among patients in the intervention arm compared to those in the control group.
","[{'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Kubo', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA, 94612.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Kurtovich', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA, 94612.'}, {'ForeName': 'MegAnn', 'Initials': 'M', 'LastName': 'McGinnis', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA, 94612.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aghaee', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA, 94612.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Altschuler', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA, 94612.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Quesenberry', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA, 94612.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Kolevska', 'Affiliation': 'Kaiser Permanente Napa/Solano Medical Center, 975 Sereno Drive, Vallejo, CA, 94589.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA, 94612.'}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Greyz-Yusupov', 'Affiliation': 'Kaiser Permanente San Rafael Medical Center, 820 Las Gallinas Ave, San Rafael, CA, 94903.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Avins', 'Affiliation': 'Kaiser Permanente Division of Research, 2000 Broadway, Oakland, CA, 94612.'}]",Psycho-oncology,['10.1002/pon.5557']
3059,32979383,Routine Early Antibiotic Use in SymptOmatic Preterm Neonates (REASON): A Pilot Randomized Controlled Trial.,,2020,,['SymptOmatic Preterm Neonates (REASON'],[],[],"[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]",[],[],,0.33529,,"[{'ForeName': 'J Lauren', 'Initials': 'JL', 'LastName': 'Ruoss', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL, USA. Electronic address: lruoss@ufl.edu.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Bazacliu', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Jordan T', 'Initials': 'JT', 'LastName': 'Russell', 'Affiliation': 'Department of Microbiology and Cell Science, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Diomel de la', 'Initials': 'D', 'LastName': 'Cruz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Filipp', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Polin', 'Affiliation': 'Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Triplett', 'Affiliation': 'Department of Microbiology and Cell Science, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Neu', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL, USA.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.09.056']
3060,32979417,Serum lipids and their association with birth weight in metformin and insulin treated patients with gestational diabetes.,"AIMS


To compare the effects of metformin and insulin treatment on maternal serum lipids in patients with gestational diabetes (GDM), and to analyse the associations between individual lipids and birth weight (BW).
METHODS


This is a secondary analysis of a randomized trial comparing metformin (n=110) and insulin (n=107) treatment of GDM. Fasting serum lipidome was measured at baseline (the time of diagnosis, mean 30 gestational weeks, gw) and at 36 gw using nuclear magnetic resonance spectroscopy.
RESULTS


Total and VLDL triglycerides and VLDL cholesterol increased from baseline to 36 gw in both treatment groups. The rise in triglycerides was greater in the metformin treated patients (p<0.01). Baseline total and VLDL triglycerides and VLDL cholesterol, and apolipoprotein B to A-1 ratio (apoB/apoA-1) associated positively with BW, more strongly in the metformin group. Among patients in the highest baseline VLDL cholesterol or apoB/apoA-1 quartile, those treated with insulin had smaller BWs than those treated with metformin (p<0.03).
CONCLUSION


Compared to insulin, metformin treatment of GDM led to higher maternal serum concentrations of triglyceride-rich lipoproteins. Especially triglycerides and cholesterol in VLDL were positively associated with BW. Women with high VLDL cholesterol or high apoB/apoA-1 may benefit from insulin treatment over metformin with respect to offspring BW.",2020,The rise in triglycerides was greater in the metformin treated patients (p<0.01).,"['treated patients with gestational diabetes', 'patients with gestational diabetes (GDM', 'Women with high VLDL cholesterol or high apoB/apoA-1']","['metformin and insulin treatment', 'metformin', 'insulin, metformin', 'metformin and insulin', 'GDM']","['maternal serum concentrations of triglyceride-rich lipoproteins', 'Fasting serum lipidome', 'rise in triglycerides', 'Total and VLDL triglycerides and VLDL cholesterol', 'Especially triglycerides and cholesterol in VLDL', 'Serum lipids and their association with birth weight', 'individual lipids and birth weight (BW', 'Baseline total and VLDL triglycerides and VLDL cholesterol, and apolipoprotein B to A-1 ratio (apoB/apoA-1', 'maternal serum lipids']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C4727084', 'cui_str': 'Lipidome'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0078207', 'cui_str': 'Very low density lipoprotein triglyceride'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}]",,0.0260123,The rise in triglycerides was greater in the metformin treated patients (p<0.01).,"[{'ForeName': 'Mikael S', 'Initials': 'MS', 'LastName': 'Huhtala', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Turku, 20014 Turku, Finland; Department of Obstetrics and Gynecology, Turku University Hospital, Kiinamyllynkatu 4-8, 20521 Turku, Finland. Electronic address: misahu@utu.fi.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Tertti', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Turku, 20014 Turku, Finland; Department of Obstetrics and Gynecology, Turku University Hospital, Kiinamyllynkatu 4-8, 20521 Turku, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine, University of Turku, 20014 Turku, Finland,; Department of Medicine, Turku University Hospital, Kiinamyllynkatu 4-8, 20521 Turku, Finland.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108456']
3061,32979429,Long-term tDCS effects on neurophysiological measures of cognitive control in tobacco smokers.,"INTRODUCTION


In this study we assessed the effects of transcranial Direct Current Stimulation (tDCS) on inhibitory control and error processing as measures of cognitive control to better understand tDCS modulation of smoking behaviour.
METHODS


Smokers were allocated to six sessions of either active tDCS (n = 34) or sham tDCS (n = 35) (https://clinicaltrials.gov/ct2/show/NCT03027687). Immediately before, one day after, and three months after all tDCS sessions, participants performed the Go-NoGo task while we measured behavioural and neurophysiological responses.
RESULTS


One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers. However, a significant improvement in reaction times, and a decrease in No-Go P3 amplitudes for smoking cues was found three months after active tDCS.
CONCLUSION


Given the direction of the effect, we speculate that tDCS has a long-term modulatory learning effect on selective attention and motor inhibition.",2020,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"['tobacco smokers', 'Smokers']","['sham tDCS', 'transcranial Direct Current Stimulation (tDCS', 'tDCS', 'active tDCS']","['No-Go P3 amplitudes for smoking cues', 'reaction times', 'behavioural and neurophysiological measures of cognitive control']","[{'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0365492,One day after the intervention no significant effect was found of active tDCS on behavioural and neurophysiological measures of cognitive control in tobacco smokers.,"[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands. Electronic address: verveer@essb.eur.nl.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107962']
3062,32979469,No difference in mid- to long-term mortality after vascular paclitaxel exposure.,"OBJECTIVES


Concern has been raised over potential paclitaxel-related increase in mortality following treatment with drug-coated balloons. We report mid- to long-term patient-level mortality in three trials from our institution.
METHODS


Patient data from the DRECOREST I and II trials as well as the FINNPTX-trial were included for analysis. The DRECOREST I involved patients with stenosis in a bypass vein graft, and the DRECOREST II included patients with stenosis in a dialysis fistula. The FINNPTX -trial randomized patients to either a prosthetic bypass or drug-eluting stent for long femoropopliteal lesions. Since the present retrospective study addressed mortality related to intravascular paclitaxel exposure, and population data in Finland are comprehensive, we were able to include all patients exposed to paclitaxel in the three trials. Mortality data were extracted from the population registry as well as patient records. Survival rates were analyzed for all trials pooled and separately. Late mortality was retrospectively analyzed and cross-referenced with national registry data.
RESULTS


A total of 142 patients were included, 76 treated with paclitaxel eluting device and 66 without. Mean follow-up time for survivors was 3.9 years. Overall all-cause mortality was 31.7% during follow-up. In the DRECOREST I -trial 35.5% patients died in the paclitaxel group and 37.9% in the control group (p=.84). In the DRECOREST II, overall mortality was 55.6% in paclitaxel group and 44.4% in the control group (p=.51). In the FINNPTX-trial 22.2% died in the paclitaxel group and 10.5% in the control group during follow-up (p=.30). No single cause of death was overrepresented. The most common causes of death in both groups were cardiovascular death, 59.3% in the paclitaxel group and 52.4% in the control group (p=.733) followed by malignancy (14.8% vs. 14.3% in the groups respectively).
CONCLUSIONS


No significant difference was seen in the overall analysis between paclitaxel and control group. A statistically non-significant elevated late mortality in the FINNPTX-trial after paclitaxel exposure was observed. However, the numbers in the individual trials are small, and should be interpreted in the context of future patient-level meta-analysis.",2020,"The most common causes of death in both groups were cardiovascular death, 59.3% in the paclitaxel group and 52.4% in the control group (p=.733) followed by malignancy (14.8% vs. 14.3% in the groups respectively).
","['patients with stenosis in a bypass vein graft, and the DRECOREST II included patients with stenosis in a dialysis fistula', 'A total of 142 patients were included, 76 treated with paclitaxel eluting device and 66 without']","['paclitaxel', 'prosthetic bypass or drug-eluting stent', 'FINNPTX']","['Late mortality', 'Mortality data', 'death', 'Overall all-cause mortality', 'late mortality', 'cardiovascular death', 'overall mortality', 'mortality', 'Survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",142.0,0.0725409,"The most common causes of death in both groups were cardiovascular death, 59.3% in the paclitaxel group and 52.4% in the control group (p=.733) followed by malignancy (14.8% vs. 14.3% in the groups respectively).
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Björkman', 'Affiliation': 'Helsinki University Hospital, Abdominal Center, Dept. of Vascular Surgery. Electronic address: patrick.bjorkman@hus.fi.'}, {'ForeName': 'Eeva-Maija', 'Initials': 'EM', 'LastName': 'Weselius', 'Affiliation': 'Helsinki University Hospital, Abdominal Center, Dept. of Vascular Surgery.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Venermo', 'Affiliation': 'Helsinki University Hospital, Abdominal Center, Dept. of Vascular Surgery.'}]",Annals of vascular surgery,['10.1016/j.avsg.2020.08.147']
3063,32977221,Concordance between CA-125 and RECIST progression in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer treated in the SOLO2 trial with olaparib as maintenance therapy after response to chemotherapy.,"BACKGROUND


Limited evidence exists to support CA-125 as a valid surrogate biomarker for progression in patients with ovarian cancer on maintenance PARP inhibitor (PARPi) therapy. We aimed to assess the concordance between CA-125 and Response Evaluation Criteria in Solid Tumours (RECIST) criteria for progression in patients with BRCA mutations on maintenance PARPi or placebo.
METHODS


We extracted data on progression as defined by Gynecologic Cancer InterGroup CA-125, investigator- and independent central-assessed RECIST from the SOLO2/ENGOT-ov21(NCT01874353) trial. We excluded those with progression other than by RECIST, progression on date of randomisation, and no repeat CA-125 beyond baseline. We evaluated the concordance between CA-125 progression and RECIST progression, and assessed the negative (NPV) and positive predictive value (PPV).
RESULTS


Of 295 randomised patients, 275 (184 olaparib, 91 placebo) were included. 171 patients had investigator-assessed RECIST progression. Of 80 patients with CA-125 progression, 77 had concordant RECIST progression (PPV 96%, 95% confidence interval 90-99%). Of 195 patients without CA-125 progression, 94 had RECIST progression (NPV 52%, 45-59%). Within treatment arms, PPV was similar (olaparib: 95% [84-99%], placebo: 97% [87-100%]) but NPV was lower in patients on placebo (olaparib: 60% [52-68%], placebo: 30% [20-44%]). Of 94 patients with RECIST but without CA-125 progression, 64 (68%) had CA-125 that remained within normal range. We observed similar findings using independent-assessed RECIST.
CONCLUSIONS


Almost half the patients without CA-125 progression had RECIST progression, and most of these had CA-125 within the normal range. Regular computed tomography imaging should be considered as part of surveillance in patients treated with or without maintenance olaparib rather than relying on CA-125 alone.",2020,"Within treatment arms, PPV was similar (olaparib: 95% [84-99%], placebo: 97% [87-100%]) but NPV was lower in patients on placebo (olaparib: 60% [52-68%], placebo: 30% [20-44%]).","['patients with BRCA mutations on maintenance PARPi or placebo', 'patients treated with or without maintenance olaparib rather than relying on CA-125 alone', '295 randomised patients, 275 (184 olaparib, 91', 'patients with ovarian cancer on maintenance PARP inhibitor (PARPi) therapy', '171 patients had investigator-assessed RECIST progression', 'patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer']","['placebo', 'Regular computed tomography imaging']","['PPV', 'RECIST progression', 'CA-125 progression and RECIST progression, and assessed the negative (NPV) and positive predictive value (PPV', 'concordant RECIST progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0729619', 'cui_str': 'Computed tomography imaging - action'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",80.0,0.112487,"Within treatment arms, PPV was similar (olaparib: 95% [84-99%], placebo: 97% [87-100%]) but NPV was lower in patients on placebo (olaparib: 60% [52-68%], placebo: 30% [20-44%]).","[{'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Tjokrowidjaja', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia; Department of Medical Oncology, St George Hospital, Kogarah, NSW 2217, Australia. Electronic address: angelina.tjokrowidjaja@ctc.usyd.edu.au.'}, {'ForeName': 'Chee K', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia; Department of Medical Oncology, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Department of Medical Oncology, Prince of Wales Hospital, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Gladieff', 'Affiliation': 'Department of Medical Oncology, Institut Claudius Regaud, IUCT-Oncopole, 31059 Toulouse, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, University College London, London WC1E 6DD, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Penson', 'Affiliation': 'Division of Hematology and Oncology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Korach', 'Affiliation': 'Gynecologic Oncology Department, Sheba Medical Center, Sackler School of Medicine, Tel Aviv University, 52621 Tel Aviv, Israel.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Huzarski', 'Affiliation': 'Department of Genetics and Pathology, Pomeranian Medical University, 70-204 Szczecin, Poland.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': 'Hospital 12 de Octubre, 28041 Madrid, Spain.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Pisano', 'Affiliation': 'Department of Urogynecology, National Cancer Institute, Pascale Foundation (Scientific Institute for Research and Healthcare), 80131 Naples, Italy.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Lord', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, NSW 2050, Australia; School of Medicine, The University of Notre Dame, Sydney, NSW 2007, Australia.'}, {'ForeName': 'Se Ik', 'Initials': 'SI', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, South Korea.'}, {'ForeName': 'Jung-Yun', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, South Korea.""}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Gynecology Program, European Institute of Oncology, IRCCS, 20141 Milan, Italy; School of Medicine and Surgery, University Milan Bicocca, 20126 Milan, Italy.'}, {'ForeName': 'Tjoung-Won', 'Initials': 'TW', 'LastName': 'Park-Simon', 'Affiliation': 'Department of Gynaecology and Obstetrics, Medical University Hannover, 30625 Hannover, Germany.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama 350-0495, Japan.'}, {'ForeName': 'Gabe', 'Initials': 'G', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, 1066 CX Amsterdam, the Netherlands.'}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Department of Oncology, KU Leuven - University of Leuven, B-3000 Leuven, Belgium; Division of Gynaecological Oncology, University Hospitals Leuven, B-3000 Leuven, Belgium.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul 03080, South Korea.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': 'Université Paris Descartes, Paris, France; ARCAGY-GINECO, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.021']
3064,32977252,Skim milk as a recovery beverage after exercise is superior to a sports drink for reducing next-day postprandial blood glucose and increasing postprandial fat oxidation.,"We determined the effect of consuming low-glycemic index (LGI) skim milk compared to a high-glycemic index (HGI) sports drink following evening exercise on fat oxidation and blood lipids after a subsequent high-energy breakfast. We hypothesized that postexercise skim milk consumption, compared to sports drink, would increase fat oxidation and lower harmful blood lipid and glucose concentrations after a next-day high-energy breakfast. In this randomized counterbalanced crossover trial, 20 overweight-obese participants (body mass index ≥ 25 kg/m 2 ) underwent 4 conditions: 90-minute exercise (50% Vo 2peak ) followed by sports drink (EX-HGI), exercise followed by isoenergetic skim milk (EX-LGI), exercise followed by water (Exercise), and a control condition (Control). The amount of the sports drink or milk consumed postexercise was based on the energy used during exercise plus 10%. Blood lipids, glucose, and fat oxidation were assessed before and for 6 hours after a high-energy breakfast the next morning. Fat oxidation was highest for EX-LGI (6.7 ± 2.7 g/h) and lowest for EX-HGI (6.0 ± 1.8 g/h) (condition main effect; P = .042). Triglyceride concentration and total area under the curve were higher with EX-HGI than Exercise (1.7 ± 1.6 vs 1.3 ± 1.0 mmol/L, P = .037, and 11.7 ± 9.4 vs 8.6 ± 6.0 mmol L -1  h, P = .005, respectively). Glucose concentration was lower with EX-LGI than EX-HGI (4.1 ± 1.1 vs 4.4 ± 1.1 mmol/L, P = .027). Homeostatic model assessment of insulin resistance was higher with EX-HGI than Control (2.32 ± 1.15 vs 1.86 ± 0.97, P = .005). In conclusion, evening postexercise skim milk consumption, compared with a high-GI sports drink, significantly reduced blood glucose and possibly increased fat oxidation after a high-energy breakfast the next morning.",2020,"Homeostatic model assessment of insulin resistance was higher with EX-HGI than Control (2.32 ± 1.15 vs 1.86 ± 0.97, P = .005).",['20 overweight-obese participants (body mass index ≥\u202f25\u202fkg/m 2 ) underwent'],"['consuming low-glycemic index (LGI) skim milk', '4 conditions: 90-minute exercise (50% Vo 2peak ) followed by sports drink (EX-HGI), exercise followed by isoenergetic skim milk (EX-LGI), exercise followed by water (Exercise), and a control condition (Control', 'Skim milk']","['blood glucose', 'fat oxidation', 'fat oxidation and lower harmful blood lipid and glucose concentrations', 'Glucose concentration', 'Fat oxidation', 'Triglyceride concentration and total area under the curve', 'Blood lipids, glucose, and fat oxidation', 'fat oxidation and blood lipids', 'Homeostatic model assessment of insulin resistance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0452461', 'cui_str': 'Sports drink'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",20.0,0.0207451,"Homeostatic model assessment of insulin resistance was higher with EX-HGI than Control (2.32 ± 1.15 vs 1.86 ± 0.97, P = .005).","[{'ForeName': 'Ruirui', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5B2; Sport Science College, Beijing Sport University, Beijing 100084, China. Electronic address: ruirui.gao@usask.ca.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Rapin', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5B2. Electronic address: nicole.rapin@usask.ca.'}, {'ForeName': 'Abdulrahman M', 'Initials': 'AM', 'LastName': 'Elnajmi', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5B2. Electronic address: abe823@mail.usask.ca.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5B2. Electronic address: julianne.rooke@usask.ca.'}, {'ForeName': 'Gordon A', 'Initials': 'GA', 'LastName': 'Zello', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5E5. Electronic address: gaz511@campus.usask.ca.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada S7N 5B2. Electronic address: phil.chilibeck@usask.ca.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.007']
3065,32977253,Beneficial effect of l-arginine in women using assisted reproductive technologies: a small-scale randomized controlled trial.,"This small-scale randomized controlled study aimed to examine the effect of l-arginine supplementation on the human chorionic gonadotropin (hCG)-positive rate and clinical pregnancy rate (CPR) in women undergoing assisted reproductive technology (ART) treatment for 3 months. From November 2017 to March 2018, 120 patients aged less than 40 years and planning for egg retrieval for embryo transfer were enrolled. The patients were divided into the AS2000 group (n = 36; l-arginine, 2 g; folate, 400 μg; and vitamin E, 10 mg), AS1000 group (n = 37; l-arginine, 1 g; and folate, 200 μg), and control group (n = 36). The main outcome was the hCG-positive rate or CPR in 3 months. The cumulative hCG-positive rates during the administration period were 44.2%, 54.2%, and 52.1%, and the CPRs were 39.5%, 41.7%, and 47.9% in the control, AS1000, and AS2000 groups, respectively. Odds ratios of the hCG-positive rate and CPR in the global l-arginine group (AS1000 and AS2000) versus those in the control group were 1.33 (95% confidence interval [CI], 0.62-2.90) and 1.11 (95% CI, 0.51-2.46), respectively. In the subgroup of women receiving ART because of male infertility, the hCG-positive rate and CPR were significantly increased in the l-arginine groups compared to those in the control group (13.42 [95% CI, 1.42-366.9] and 13.62 (95% CI, 1.42-367.6), respectively). Thus, arginine supplementation may be an option for women who desire pregnancy, especially those undergoing an ART program because of male infertility.",2020,"In the subgroup of women receiving ART because of male infertility, the hCG-positive rate and CPR were significantly increased in the l-arginine groups compared to those in the control group (13.42 [95% CI, 1.42-366.9] and 13.62 (95% CI, 1.42-367.6), respectively).","['women who desire pregnancy, especially those undergoing an ART program because of male infertility', 'From November 2017 to March 2018, 120 patients aged less than 40 years and planning for egg retrieval for embryo transfer were enrolled', 'women undergoing assisted reproductive technology (ART) treatment for 3 months', 'women using assisted reproductive technologies']","['l-arginine', 'AS2000 group (n\u202f=\u202f36; l-arginine, 2 g; folate, 400 μg; and vitamin E', 'arginine supplementation', 'l-arginine supplementation']","['cumulative hCG-positive rates', 'human chorionic gonadotropin (hCG)-positive rate and clinical pregnancy rate (CPR', 'CPRs', 'hCG-positive rate or CPR', 'hCG-positive rate and CPR', 'Odds ratios of the hCG-positive rate and CPR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035157', 'cui_str': 'Reproductive Technologies'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021364', 'cui_str': 'Male infertility'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0872104', 'cui_str': 'Assisted reproductive technology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C3203517', 'cui_str': 'Human chorionic gonadotropin positive'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",120.0,0.311347,"In the subgroup of women receiving ART because of male infertility, the hCG-positive rate and CPR were significantly increased in the l-arginine groups compared to those in the control group (13.42 [95% CI, 1.42-366.9] and 13.62 (95% CI, 1.42-367.6), respectively).","[{'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'So', 'Affiliation': 'Department of Reproductive and Perinatal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka 431-3192, Japan; Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan. Electronic address: so@hama-med.ac.jp.'}, {'ForeName': 'Wakasa', 'Initials': 'W', 'LastName': 'Yamaguchi', 'Affiliation': 'Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Murabayashi', 'Affiliation': 'Department of Reproductive and Perinatal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka 431-3192, Japan; Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Miyano', 'Affiliation': 'Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan.'}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Tawara', 'Affiliation': 'Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Kanayama', 'Affiliation': 'Tawara IVF clinic, 2-20, Izumi-cho, Suruga-ku Shizuoka-shi, Shizuoka 422-8066, Japan; Department of Obstetrics and Gynecology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka 431-3192, Japan.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.008']
3066,32977254,"Low anthocyanin plum nectar does not impact cognition, blood pressure and gut microbiota in healthy older adults: A randomized crossover trial.","Queen Garnet plum (QGP), known for its high levels of anthocyanins, is a hybrid of the Japanese plum developed in Queensland, Australia. Anthocyanins provide the red, blue, and purple pigments in plants with demonstrated beneficial health effects. This study hypothesized that low-dose anthocyanin QGP intake will have a significant positive effect on cognition, blood pressure, and gut microbiota in healthy older adults. A randomized crossover trial was conducted to determine the effect and within subject variance on cognition and 24 hr. ambulatory blood pressure in older adults without cognitive impairment following daily consumption of 200 mL low-dose anthocyanin (5 mg/100 g) QGP nectar (intervention) or raspberry cordial (control). Secondary outcomes included inflammatory markers (C-reactive protein), nerve growth factor (BDNF), and gut microbiota (16S rRNA gene sequencing). Twenty-eight participants (55+ years) were recruited. Each randomized treatment arm lasted for 8 weeks with a 4-week washout period. Cognition, blood pressure, and urine samples were measured at each visit (5 total) while blood and fecal samples were collected at baseline, 8 weeks, and 20 weeks. Repeated-measures ANOVA was used to analyze the data. Across the treatments, no significant difference was observed for the different domains of cognition, blood pressure, or anti-inflammatory biomarkers. No intervention effect was found for genera or class of gut microbes. Low anthocyanin nectar derived from the QGP did not have any significant effects on cognition, blood pressure, or gut microbiota in healthy older adults.",2020,"Across the treatments, no significant difference was observed for the different domains of cognition, blood pressure, or anti-inflammatory biomarkers.","['older adults without cognitive impairment following', 'Twenty-eight participants (55+ years) were recruited', 'healthy older adults']","['Queen Garnet plum (QGP', 'daily consumption of 200 mL low-dose anthocyanin (5 mg/100 g) QGP nectar (intervention) or raspberry cordial (control', 'anthocyanin QGP intake', 'Low anthocyanin plum nectar']","['genera or class of gut microbes', 'cognition, blood pressure, or anti-inflammatory biomarkers', 'cognition, blood pressure, and gut microbiota', 'blood pressure and gut microbiota', 'inflammatory markers (C-reactive protein), nerve growth factor (BDNF), and gut microbiota (16S rRNA gene sequencing', 'cognition, blood pressure, or gut microbiota', 'ambulatory blood pressure', 'Cognition, blood pressure, and urine samples']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0330660', 'cui_str': 'Prunus domestica'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C2717960', 'cui_str': 'Nectar'}, {'cui': 'C0453292', 'cui_str': 'Raspberries'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0035899', 'cui_str': 'Ribosomal RNA Genes'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]",,0.0441453,"Across the treatments, no significant difference was observed for the different domains of cognition, blood pressure, or anti-inflammatory biomarkers.","[{'ForeName': 'Ezinne O', 'Initials': 'EO', 'LastName': 'Igwe', 'Affiliation': 'School of Medicine, University of Wollongong, Wollonggong, NSW, Australia; Illawarra Health and Medical Research Institute, University of Wollongong, Wollonggong, NSW, Australia. Electronic address: ekorie@uow.edu.au.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Roodenrys', 'Affiliation': 'School of Psychology, University of Wollongong, Wollonggong, NSW, Australia.'}, {'ForeName': 'Yasmine C', 'Initials': 'YC', 'LastName': 'Probst', 'Affiliation': 'School of Medicine, University of Wollongong, Wollonggong, NSW, Australia; Illawarra Health and Medical Research Institute, University of Wollongong, Wollonggong, NSW, Australia.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'do Rosario', 'Affiliation': 'School of Medicine, University of Wollongong, Wollonggong, NSW, Australia; Illawarra Health and Medical Research Institute, University of Wollongong, Wollonggong, NSW, Australia.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Netzel', 'Affiliation': 'Queensland Alliance for Agriculture and Food Innovation, The University of Queensland, Coopers Plains, QLD 4108, Australia.'}, {'ForeName': 'Hung T', 'Initials': 'HT', 'LastName': 'Hong', 'Affiliation': 'Queensland Alliance for Agriculture and Food Innovation, The University of Queensland, Coopers Plains, QLD 4108, Australia.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Netzel', 'Affiliation': 'Queensland Alliance for Agriculture and Food Innovation, The University of Queensland, Coopers Plains, QLD 4108, Australia.'}, {'ForeName': 'Anh D T', 'Initials': 'ADT', 'LastName': 'Phan', 'Affiliation': 'Queensland Alliance for Agriculture and Food Innovation, The University of Queensland, Coopers Plains, QLD 4108, Australia.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Charlton', 'Affiliation': 'School of Medicine, University of Wollongong, Wollonggong, NSW, Australia; Illawarra Health and Medical Research Institute, University of Wollongong, Wollonggong, NSW, Australia.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.003']
3067,32977661,Acute Effects of Aerobic Exercise on Somatosensory-Evoked Potentials in Patients with Mild Cognitive Impairment.,"Mild cognitive impairment (MCI) is becoming a serious problem for developing countries as the lifespan of populations increases. Exercise is known to be clinically beneficial for MCI patients. Somatosensory-evoked potentials (SEPs) may be a potential diagnostic and prognostic marker for this population. The objective of this study was to determine the acute effects of aerobic exercise on SEPs in patients with MCI, to test whether SEPs are sensitive enough to detect improvements in early somatosensory processing. The study had a randomized parallel-group design and included 28 MCI subjects (14 in the experimental group and 14 in the control group). The experimental intervention was 20 min of aerobic exercise using a stationary bicycle. The control intervention involved 20 min of movements and stretches. Subjects were assessed before and after a single intervention session. SEPs were recorded by stimulating the median nerve of the dominant hand. Analysis of normalized SEP peak amplitudes showed that a single session of aerobic activity significantly reduced the N30 peak at the F3 channel ( p  = 0.03). There were no significant effects of aerobic exercise on SEP peak latencies. The results indicate that 20 min of aerobic exercise has a significant effect on the N30 SEP peak amplitude in MCI patients. The results suggest that aerobic exercise is likely to provide sensory-enriching inputs that enhance sensorimotor integration. Future studies should assess the effects of aerobic exercise on somatosensory processing in progressive stages of Alzheimer's disease, longer exercise durations, and multiple exercise sessions.",2020,The results indicate that 20 min of aerobic exercise has a significant effect on the N30 SEP peak amplitude in MCI patients.,"['patients with MCI', 'Patients with Mild Cognitive Impairment', 'Mild cognitive impairment (MCI', '28 MCI subjects (14 in the experimental group and 14 in the control group']","['aerobic exercise using a stationary bicycle', 'Aerobic Exercise', 'aerobic exercise', 'Somatosensory-evoked potentials (SEPs']","['N30 SEP peak amplitude', 'SEP peak latencies', 'normalized SEP peak amplitudes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0392218', 'cui_str': 'Bicycle exerciser'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",28.0,0.0984768,The results indicate that 20 min of aerobic exercise has a significant effect on the N30 SEP peak amplitude in MCI patients.,"[{'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Amjad', 'Affiliation': 'Neurobiology Laboratory, Department of Healthcare Biotechnology, Atta-ur-Rahman School of Applied Biosciences, National University of Sciences and Technology, Islamabad 44000, Pakistan.'}, {'ForeName': 'Imran Khan', 'Initials': 'IK', 'LastName': 'Niazi', 'Affiliation': 'Center of Chiropractic Research New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Hamza Ghazanfar', 'Initials': 'HG', 'LastName': 'Toor', 'Affiliation': 'Faculty of Rehabilitation and Allied Sciences & Faculty of Engineering and Applied Sciences, Riphah International University, Islamabad 44000, Pakistan.'}, {'ForeName': 'Rasmus Bach', 'Initials': 'RB', 'LastName': 'Nedergaard', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, 9000 Aalborg, Denmark.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Shafique', 'Affiliation': 'Faculty of Rehabilitation and Allied Sciences & Faculty of Engineering and Applied Sciences, Riphah International University, Islamabad 44000, Pakistan.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'Center of Chiropractic Research New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Haavik', 'Affiliation': 'Center of Chiropractic Research New Zealand College of Chiropractic, Auckland 1060, New Zealand.'}, {'ForeName': 'Touqeer', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'Neurobiology Laboratory, Department of Healthcare Biotechnology, Atta-ur-Rahman School of Applied Biosciences, National University of Sciences and Technology, Islamabad 44000, Pakistan.'}]",Brain sciences,['10.3390/brainsci10100663']
3068,32977683,"The Effectiveness of Narrative Versus Didactic Information Formats on Pregnant Women's Knowledge, Risk Perception, Self-Efficacy, and Information Seeking Related to Climate Change Health Risks.","Climate change is a global threat that poses significant risks to pregnant women and to their developing fetus and newborn. Educating pregnant women about the risks to their pregnancy may improve maternal and child health outcomes. Prior research suggests that presenting health information in narrative format can be more effective than a didactic format. Hence, the purpose of this study was to test the effectiveness of two brief educational interventions in a diverse group of pregnant women ( n  = 151). Specifically, using a post-test only randomized experiment, we compared the effectiveness of brief information presented in a narrative format versus a didactic format; both information formats were also compared to a no information control group. Outcome measures included pregnant women's actual and perceived knowledge, risk perception, affective assessment, self-efficacy, intention to take protective behaviors, and subsequent information seeking behavior. As hypothesized, for all outcome measures, the narrative format was more effective than the didactic format. These results suggest the benefits of a narrative approach (versus a didactic approach) to educating pregnant women about the maternal and child health threats posed by climate change. This study adds to a growing literature on the effectiveness of narrative-based approaches to health communication.",2020,"Outcome measures included pregnant women's actual and perceived knowledge, risk perception, affective assessment, self-efficacy, intention to take protective behaviors, and subsequent information seeking behavior.","[""Pregnant Women's"", 'Educating pregnant women', 'diverse group of pregnant women ( n  = 151']","['Narrative Versus Didactic Information Formats', 'narrative approach (versus a didactic approach', 'educational interventions']","[""pregnant women's actual and perceived knowledge, risk perception, affective assessment, self-efficacy, intention to take protective behaviors, and subsequent information seeking behavior"", 'Knowledge, Risk Perception, Self-Efficacy, and Information Seeking']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0596775', 'cui_str': 'Information Seeking Behavior'}]",,0.0267453,"Outcome measures included pregnant women's actual and perceived knowledge, risk perception, affective assessment, self-efficacy, intention to take protective behaviors, and subsequent information seeking behavior.","[{'ForeName': 'Adebanke L', 'Initials': 'AL', 'LastName': 'Adebayo', 'Affiliation': 'Department at George Mason University, George Mason University, Fairfax, VA 22030, USA.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Davidson Mhonde', 'Affiliation': 'Department at George Mason University, George Mason University, Fairfax, VA 22030, USA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'DeNicola', 'Affiliation': 'School of Medicine and Health Sciences, The George Washington University, Washington, DC 20052, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Maibach', 'Affiliation': 'Center for Climate Change Communication, George Mason University, Fairfax, VA 22030, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17196969']
3069,32977684,Nutrition Education Intervention Increases Fish Consumption among School Children in Indonesia: Results from Behavioral Based Randomized Control Trial.,"This study aimed to analyze the effectiveness of behavioral-based nutrition education to increase fish consumption among school children using a raised bed pool. This was a randomized control trial study with a 3-months nutrition education intervention using a raised bed pool, as a medium to improve their internalization to increase fish consumption behavior. A paired  t -test was used to calculate the difference in the increase of fish consumption, knowledge, attitude, perceived behavioral control, subjective norm, and intention. This study took place in a majority of low to medium urban households in Surabaya in Sidotopo Wetan I and Sidotopo Wetan II elementary school. Elementary school children at 4th and 5th grade and mother of elementary school children with 104 children were eligible and willing to participate. After the completion of interventions, significant improvement in delta-mean and effectiveness observed in attitude, subjective norm, perceived behavioral control, intention, knowledge, and fish consumption ( p  < 0.001). The 3 months of nutrition education intervention based on the theory of planned behavior significantly increase fish consumption among elementary school children. The increased consumption was believed to be related to the increase in children's knowledge and attitude towards consuming fish.",2020,"After the completion of interventions, significant improvement in delta-mean and effectiveness observed in attitude, subjective norm, perceived behavioral control, intention, knowledge, and fish consumption ( p  < 0.001).","['Elementary school children at 4th and 5th grade and mother of elementary school children with 104 children were eligible and willing to participate', 'School Children in Indonesia', 'elementary school children', 'school children using a raised bed pool', 'majority of low to medium urban households in Surabaya in Sidotopo Wetan']","['Nutrition Education Intervention', 'nutrition education intervention', '3-months nutrition education intervention', 'behavioral-based nutrition education']","['delta-mean and effectiveness observed in attitude, subjective norm, perceived behavioral control, intention, knowledge, and fish consumption', 'fish consumption, knowledge, attitude, perceived behavioral control, subjective norm, and intention']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",104.0,0.0209479,"After the completion of interventions, significant improvement in delta-mean and effectiveness observed in attitude, subjective norm, perceived behavioral control, intention, knowledge, and fish consumption ( p  < 0.001).","[{'ForeName': 'Trias', 'Initials': 'T', 'LastName': 'Mahmudiono', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Universitas Airlangga, Jl. Mulyorejo Kampus C, Surabaya 60115, Indonesia.'}, {'ForeName': 'Triska Susila', 'Initials': 'TS', 'LastName': 'Nindya', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Universitas Airlangga, Jl. Mulyorejo Kampus C, Surabaya 60115, Indonesia.'}, {'ForeName': 'Qonita', 'Initials': 'Q', 'LastName': 'Rachmah', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Universitas Airlangga, Jl. Mulyorejo Kampus C, Surabaya 60115, Indonesia.'}, {'ForeName': 'Calista', 'Initials': 'C', 'LastName': 'Segalita', 'Affiliation': 'Department of Nutrition, Faculty of Public Health, Universitas Airlangga, Jl. Mulyorejo Kampus C, Surabaya 60115, Indonesia.'}, {'ForeName': 'Luh Ade Ari', 'Initials': 'LAA', 'LastName': 'Wiradnyani', 'Affiliation': 'Southeast Asian Ministers of Education Organization Regional Centre for Food and Nutrition (SEAMEO RECFON) Pusat Kajian Gizi Regional (PKGR), Universitas Indonesia, Jl. Salemba Raya No.6, Jakarta Pusat 10430, Indonesia.'}]",International journal of environmental research and public health,['10.3390/ijerph17196970']
3070,32977710,Food Consumption and Emotions at a Salad Lunch Buffet in a Multisensory Environment.,"The food experience is multisensory and multisensory external stimuli may affect food choice and emotions. The objective of this study was to evaluate the effect of a multisensory eating environment on food choice, intake and the emotional states of the subjects in a salad lunch buffet setting. A total of 30 female subjects consumed a salad lunch twice in the multisensory laboratory. The two test conditions (control and multisensory condition with environmental stimuli) were randomized and the visits were scheduled one week apart. Subjects selected and ate a meal from a salad buffet including 14 food items and the intake of each item was weighed. They answered an online questionnaire about the meal and their emotional states (20 different emotion terms) after the lunch. There was no significant difference in the food consumption between the control and multisensory conditions. The subjects were very satisfied with their lunch for both study visits but the pleasantness of the eating environment was rated higher under the multisensory condition. In emotional terms, the subjects selected the term ""happy"" significantly more frequently under the multisensory condition compared with the control. In conclusion, the multisensory eating environment in this study was not related to food intake but may be associated with positive emotions. The effect of the eating environment on food choice and experience deserves further study with a larger study population in a real lunch restaurant setting.",2020,There was no significant difference in the food consumption between the control and multisensory conditions.,"['subjects in a salad lunch buffet setting', '30 female subjects consumed a salad lunch twice in the multisensory laboratory']","['eating environment', 'multisensory eating environment']","['food consumption', 'Food Consumption and Emotions']","[{'cui': 'C0453740', 'cui_str': 'Salad'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",30.0,0.0313404,There was no significant difference in the food consumption between the control and multisensory conditions.,"[{'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Hoppu', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Puputti', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Saila', 'Initials': 'S', 'LastName': 'Mattila', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Marjaana', 'Initials': 'M', 'LastName': 'Puurtinen', 'Affiliation': 'Department of Teacher Education, University of Turku, 20014 Turku, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Sandell', 'Affiliation': 'Functional Foods Forum, University of Turku, 20014 Turku, Finland.'}]","Foods (Basel, Switzerland)",['10.3390/foods9101349']
3071,32977747,Risk of active tuberculosis among COPD patients treated with fixed combinations of long-acting beta2 agonists and inhaled corticosteroids.,"OBJECTIVES


To investigate the incidence of active tuberculosis (TB) among COPD patients using fluticasone/salmeterol or budesonide/formoterol, and to identify any differences between these two groups of patients.
METHODS


The study enrolled COPD patients from Taiwan NHIRD who received treatment with fluticasone/salmeterol or budesonide/formoterol for > 90 days between 2004 and 2011. The incidence of active TB was the primary outcome.
RESULTS


Among the intention-to-treat population prior to matching, the incidence rates of active TB were 0.94 and 0.61% in the fluticasone/salmeterol and budesonide/formoterol groups, respectively. After matching, the fluticasone/salmeterol group had significantly higher rates of active TB (adjusted HR, 1.41, 95% CI, 1.17-1.70) compared with the budesonide/formoterol group. The significant difference between these two groups remained after a competing risk analysis (HR, 1.45, 95% CI, 1.21-1.74). Following propensity score matching, the fluticasone/salmeterol group had significantly higher rates of active TB compared with the budesonide/formoterol group (adjusted HR, 1.45, 95% CI, 1.14-1.85). A similar trend was observed after a competing risk analysis (HR, 1.44, 95% CI, 1.19-1.75). A higher risk of active TB was observed in the fluticasone/salmeterol group compared with the budesonide/formoterol group across all subgroups, but some differences did not reach statistical significance.
CONCLUSION


Fluticasone/salmeterol carried a higher risk of active TB compared with budesonide/formoterol among COPD patients.",2020,"A higher risk of active TB was observed in the fluticasone/salmeterol group compared with the budesonide/formoterol group across all subgroups, but some differences did not reach statistical significance.
","['COPD patients', 'COPD patients using', 'enrolled COPD patients from Taiwan NHIRD who received treatment with', 'for >\u200990\u2009days between 2004 and 2011']","['fluticasone/salmeterol and budesonide/formoterol', 'fluticasone/salmeterol', 'fluticasone/salmeterol or budesonide/formoterol', 'Fluticasone/salmeterol', 'budesonide/formoterol', 'inhaled corticosteroids']","['risk of active TB', 'incidence of active tuberculosis (TB', 'rates of active TB', 'incidence rates of active TB', 'incidence of active TB']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439083', 'cui_str': '>90'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0939232', 'cui_str': 'salmeterol and fluticasone'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.592234,"A higher risk of active TB was observed in the fluticasone/salmeterol group compared with the budesonide/formoterol group across all subgroups, but some differences did not reach statistical significance.
","[{'ForeName': 'Tsan-Ming', 'Initials': 'TM', 'LastName': 'Huang', 'Affiliation': 'Department of Internal Medicine, Cardinal Tien Hospital and School of Medicine, College of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan.'}, {'ForeName': 'Kuan-Chih', 'Initials': 'KC', 'LastName': 'Kuo', 'Affiliation': 'Division of Pulmonary, Department of Internal Medicine, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ya-Hui', 'Initials': 'YH', 'LastName': 'Wang', 'Affiliation': 'Medical Research Center, Cardinal Tien Hospital and School of Medicine, College of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan.'}, {'ForeName': 'Cheng-Yi', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Cardinal Tien Hospital and School of Medicine, College of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan.'}, {'ForeName': 'Chih-Cheng', 'Initials': 'CC', 'LastName': 'Lai', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Veterans General Hospital, Tainan Branch, Tainan, Taiwan. dtmed141@gmail.com.'}, {'ForeName': 'Hao-Chien', 'Initials': 'HC', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan. haochienwang@gmail.com.'}, {'ForeName': 'Likwang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Miaoli County, Taiwan.'}, {'ForeName': 'Chong-Jen', 'Initials': 'CJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC infectious diseases,['10.1186/s12879-020-05440-6']
3072,32977992,The effect of resistance training on sleep in Chinese older adults: A randomized controlled trial.,"Sleep disturbances affect approximately half of the older adult population and add additional risks of developing Alzheimer's disease. This study is to test the effects of a 12-week resistance training (RT) program on sleep in older adults residing in an assisted living facility in China. A total of 62 eligible participants were randomly assigned to RT (n = 31) or control group (n = 31). Participants in RT group participated in three 1-hour moderate intensity RT sessions per week for 12 weeks (at least 48 h between sessions). In the overall sample, sleep efficiency increased (P < 0.01), wake after sleep onset (P < 0.01) decreased in participants in RT group at post-intervention, compared to control group. Similar results were found in participants with mild cognitive impairment (MCI). The findings support that RT improves sleep efficiency and decreases sleep fragmentation in older adults in general and in those with MCI.",2020,"In the overall sample, sleep efficiency increased (P < 0.01), wake after sleep onset (P < 0.01) decreased in participants in RT group at post-intervention, compared to control group.","['older adults', 'Chinese older adults', 'older adults residing in an assisted living facility in China', '62 eligible participants', 'participants with mild cognitive impairment (MCI']","['RT', 'resistance training', 'resistance training (RT) program']","['sleep fragmentation', 'sleep efficiency', 'Sleep disturbances']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0751507', 'cui_str': 'Sleep Fragmentation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",62.0,0.0289172,"In the overall sample, sleep efficiency increased (P < 0.01), wake after sleep onset (P < 0.01) decreased in participants in RT group at post-intervention, compared to control group.","[{'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""School of Nursing, Jilin University, 965 Xinjiang Street, Changchun 130021, China; Nursing department, Qingdao Women and Children's Hospital, No.6 Tongfu Road, Shibei District, Qingdao 266011, China.""}, {'ForeName': 'Junxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Guiling', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': ""Nursing department, Qingdao Women and Children's Hospital, No.6 Tongfu Road, Shibei District, Qingdao 266011, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, University of Minnesota, 5-140 Weaver-Densford Hall 308 Harvard Street SE Minneapolis, MN 55455, United States.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, 965 Xinjiang Street, Changchun 130021, China. Electronic address: lik@jlu.edu.cn.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Szanton', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, MD, United States.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.09.002']
3073,32978014,Patient-reported Quality of Life in Patients with Primary Metastatic Prostate Cancer Treated with Androgen Deprivation Therapy with and Without Concurrent Radiation Therapy to the Prostate in a Prospective Randomised Clinical Trial; Data from the HORRAD Trial.,"BACKGROUND


A survival benefit was demonstrated for patients with low-volume metastatic prostate cancer (mPCa) when local radiotherapy was added to androgen deprivation therapy (ADT).
OBJECTIVE


To determine the effect of ADT combined with external beam radiotherapy (EBRT) to the prostate on health-related quality of life (HRQoL) of patients with primary bone mPCa.
DESIGN, SETTING, AND PARTICIPANTS


The HORRAD trial is a multicentre randomised controlled trial recruiting 432patients with primary bone mPCa between 2004 and 2014.
INTERVENTION


Patients were randomised to ADT with EBRT or to ADT alone.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Patients completed two validated HRQoL questionnaires (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Core Module (QLQ-C30) and EORTC Quality of Life Questionnaire Prostate Module [QLQ-PR25]) at baseline and at 3, 6, 12, and24 mo after the initiation of treatment. The effect of both treatments was evaluated based on mixed-effect models.
RESULTS AND LIMITATIONS


Patient characteristics and HRQoL scores at baseline were similar in both arms. At baseline, 98% of patients completed the questionnaires, compared with 58% at 24 mo. Patients reported significantly more diarrhoea (difference between the groups 10.8; 95% confidence interval [CI] 7.3-14.2), bowel symptoms (4.5; 95% CI 2.1-6.8), and urinary symptoms (11.9; 95% CI 8.9-14.8) after EBRT and ADT compared with ADT alone (all between-arm difference p <  0.001). Urinary complaints levelled at 6 mo. At 2 yr, only bowel symptom scores were significantly different (8.0; 95% CI 4.8-11.1, p ≤  0.001), but 68% of patients in the radiotherapy group did not report clinically relevant worsening of their bowel symptom scores.
CONCLUSIONS


Patients with bone mPCa reported temporary modest urinary and bowel symptoms after combined treatment with EBRT of the prostate and ADT compared with ADT alone. For some patients (22%), deterioration of bowel functions remains at 2 yr, whereas general HRQoL does not deteriorate..
PATIENT SUMMARY


This study investigated the effect of radiotherapy to the prostate added to hormonal therapy on patient-reported health-related quality of life (HRQoL) in patients with primary bone metastatic prostate cancer. Most patients reported only temporary urinary and bowel symptoms. In 22% of patients, bowel symptoms remained at 2 yr, whereas general HRQoL did not deteriorate.",2020,"Patients reported significantly more diarrhoea (difference between the groups 10.8; 95% confidence interval [CI] 7.3-14.2), bowel symptoms (4.5; 95% CI 2.1-6.8), and urinary symptoms (11.9; 95% CI 8.9-14.8) after EBRT and ADT compared with ADT alone (all between-arm difference p <  0.001).","['patients with primary bone mPCa', 'Patients with Primary Metastatic Prostate Cancer Treated with', 'patients with primary bone metastatic prostate cancer', 'patients with low-volume metastatic prostate cancer (mPCa', '432patients with primary bone mPCa between 2004 and 2014']","['ADT with EBRT or to ADT alone', 'androgen deprivation therapy (ADT', 'Androgen Deprivation Therapy with and Without Concurrent Radiation Therapy', 'local radiotherapy', 'ADT combined with external beam radiotherapy (EBRT', 'radiotherapy']","['temporary urinary and bowel symptoms', 'HRQoL questionnaires (European Organization for Research and Treatment of Cancer [EORTC', 'Quality of Life', 'diarrhoea', 'temporary modest urinary and bowel symptoms', 'bowel symptoms', 'bowel symptom scores', 'patient-reported health-related quality of life (HRQoL', 'Quality of Life Questionnaire Core Module (QLQ-C30) and EORTC Quality of Life Questionnaire Prostate Module', 'deterioration of bowel functions', 'urinary symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}]",,0.273599,"Patients reported significantly more diarrhoea (difference between the groups 10.8; 95% confidence interval [CI] 7.3-14.2), bowel symptoms (4.5; 95% CI 2.1-6.8), and urinary symptoms (11.9; 95% CI 8.9-14.8) after EBRT and ADT compared with ADT alone (all between-arm difference p <  0.001).","[{'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'Boevé', 'Affiliation': 'Department of Urology, OLVG, Amsterdam, The Netherlands; Department of Urology, Amsterdam UMC, Location VU university Medical Center (VUmc), Amsterdam, The Netherlands. Electronic address: L.Boeve@olvg.nl.'}, {'ForeName': 'Maarten C C M', 'Initials': 'MCCM', 'LastName': 'Hulshof', 'Affiliation': 'Department of Radiotherapy, Amsterdam UMC, location Academic Medical Center (AMC), Amsterdam, The Netherlands.'}, {'ForeName': 'Paul C M S', 'Initials': 'PCMS', 'LastName': 'Verhagen', 'Affiliation': 'Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Location VU university Medical Center (VUmc), Amsterdam, The Netherlands.'}, {'ForeName': 'Wim P J', 'Initials': 'WPJ', 'LastName': 'Witjes', 'Affiliation': 'CuraTrial SMO & Research BV, Arnhem, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Vries', 'Affiliation': 'Department of Urology, Zuyderland, Heerlen, The Netherlands.'}, {'ForeName': 'R Jeroen A', 'Initials': 'RJA', 'LastName': 'van Moorselaar', 'Affiliation': 'Department of Urology, Amsterdam UMC, Location VU university Medical Center (VUmc), Amsterdam, The Netherlands.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'van Andel', 'Affiliation': 'Department of Urology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'André N', 'Initials': 'AN', 'LastName': 'Vis', 'Affiliation': 'Department of Urology, Amsterdam UMC, Location VU university Medical Center (VUmc), Amsterdam, The Netherlands.'}]",European urology,['10.1016/j.eururo.2020.08.023']
3074,32978017,The impact of tooth-borne vs computer-guided bone-borne rapid maxillary expansion on pain and oral health-related quality of life: A parallel cohort study.,"INTRODUCTION


The primary aim of this study was to investigate and compare perceived pain intensity and oral health-related quality of life (OHRQOL) results during the activation phase of rapid maxillary expansion (RME), with tooth-borne and bone-borne devices. In addition, a secondary aim of this study was to evaluate the correlation between pain scales and the shortened Oral Health Impact Profile (OHIP-14) questionnaire.
METHODS


Thirty-six subjects (16 girls and 20 boys) with a mean age of 12.3 years (standard deviation, 0.82 years) were randomized into 2 groups. Group A received treatment with hyrax appliance, and group B received a computer-guided skeletal RME appliance. The same type of expansion screw and screw activation or expansion protocol were used. Two rating scales were used to assess the subject's pain during the activation phase of RME: a Graphic Rating Scale for Pain (GRS) and the Wong-Baker Faces Pain Scale (FPS). The OHIP-14 was used to evaluate the impact of RME on OHRQOL before the beginning of the treatment at day 3 and day 7 follow-ups. Painkillers were forbidden during the active phase of RME. Descriptive statistics, Student t test, and Pearson correlation were used. Significance was set at P ≤0.05.
RESULTS


A total of 36 subjects, divided into 2 groups, were treated in the study. Regarding the level of pain, the Student t test showed statistically significant higher pain in group B-although only on the first day of screw activation (GRS, P = 0.01; FPS, P  <0.01). For the following days, there were no significant differences in pain levels between groups. The OHIP-14 showed no statistically significant difference at baseline (P = 0.32) and day 3 (P = 0.88) and day 7 (P = 0.85) follow-ups between the 2 groups. The Pearson correlation coefficient showed a statistically significant association between the 2 different scales of pain (GRS and FPS) but not a statistically significant correlation between GRS and FPS scales and OHIP-14.
CONCLUSIONS


A higher perceived pain intensity in the patients treated using a bone-borne computer-guided skeletal RME appliance was limited to the first day of screw activation. There were no statistically significant differences between the 2 types of treatment in terms of their impact on OHRQOL and no statistically significant correlation between pain scales and the OHIP-14 questionnaire.",2020,There were no statistically significant differences between the 2 types of treatment in terms of their impact on OHRQOL and no statistically significant correlation between pain scales and the OHIP-14 questionnaire.,"['Thirty-six subjects (16 girls and 20 boys) with a mean age of 12.3\xa0years (standard deviation, 0.82\xa0years', '36 subjects']","['computer-guided skeletal RME appliance', 'hyrax appliance', 'tooth-borne vs computer-guided bone-borne rapid maxillary expansion']","['pain and oral health-related quality of life', 'pain (GRS and FPS', 'Graphic Rating Scale for Pain (GRS) and the Wong-Baker Faces Pain Scale (FPS', 'GRS and FPS scales and OHIP-14', 'pain scales and the shortened Oral Health Impact Profile (OHIP-14) questionnaire', 'pain intensity and oral health-related quality of life (OHRQOL', 'pain levels', 'level of pain', 'pain intensity', 'pain scales and the OHIP-14 questionnaire', 'pain']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517482', 'cui_str': '0.82'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441424', 'cui_str': 'Rapid maxillary expansion appliance'}, {'cui': 'C0020696', 'cui_str': 'Family Procaviidae'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0600288', 'cui_str': 'Maxillary Expansion'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",36.0,0.0363942,There were no statistically significant differences between the 2 types of treatment in terms of their impact on OHRQOL and no statistically significant correlation between pain scales and the OHIP-14 questionnaire.,"[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Altieri', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, School of Dentistry, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cassetta', 'Affiliation': 'Department of Oral and Maxillofacial Sciences, School of Dentistry, Sapienza University of Rome, Rome, Italy. Electronic address: michele.cassetta@uniroma1.it.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.07.030']
3075,32978020,"Reprint of ""The detection of knee joint sounds at defined loads by means of vibroarthrography"".","BACKGROUND


Crepitus of the knee may mirror structural and functional changes in the joint during motion. Although the magnitude of these sounds increases with greater cartilage damage, it is unclear whether knee joint sounds also reflect joint loading.
METHODS


Twelve healthy volunteers (mean 26 (SD 3.6) years, 7 females) participated in the randomized-balanced crossover study. Knee joint sounds were recorded (linear sampling, 5512 Hz) by means of two microphones, one placed on the medial tibial plateau and one on the patella. Two activities of daily living (standing up from/sitting down on a bench; descending stairs) and three open kinetic chain knee extension-flexion cycles (passive movement, 10% and 40% loading of the individual one repetition maximum) were performed. Each participant carried out three sets of five repetitions and three sets of 15 steps downwards (stairs), respectively. For data analysis, the mean sound amplitude and the median power frequency for each loading condition were determined. Friedman test and Bonferroni-Holm adjusted post-hoc test were performed to detect differences between conditions.
FINDINGS


We obtained significant differences between joint sound amplitudes for all movements, both measured at the medial tibial plateau (Chi 2  = 20.7, p < 0.001) and at the patella (Chi 2  = 27.6, p < 0.001). We showed a significant difference in the median power frequency of the patella between all movements (Chi 2  = 17.8, p < 0.5).
INTERPRETATION


Overall, the larger the supposed knee joint loading was, the louder was the recorded knee crepitus. Consequently, vibroarthrographically assessed knee joint sounds can differ across knee joint loading conditions.",2020,"We obtained significant differences between joint sound amplitudes for all movements, both measured at the medial tibial plateau","['mean 26 (SD 3.6) years, 7 females', 'Twelve healthy volunteers']","['daily living (standing up from/sitting down on a bench; descending stairs) and three open kinetic chain knee extension-flexion cycles (passive movement, 10% and 40% loading of the individual one repetition maximum']","['medial tibial plateau', 'median power frequency of the patella', 'Knee joint sounds']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444796', 'cui_str': 'Standing up'}, {'cui': 'C0560831', 'cui_str': 'Does sit down'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0584640', 'cui_str': 'Tibial plateau structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}]",12.0,0.0360668,"We obtained significant differences between joint sound amplitudes for all movements, both measured at the medial tibial plateau","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kalo', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany. Electronic address: kalo@rz.uni-frankfurt.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Niederer', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Sus', 'Affiliation': 'Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany.'}, {'ForeName': 'Keywan', 'Initials': 'K', 'LastName': 'Sohrabi', 'Affiliation': 'Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Department of Preventive and Sports Medicine, Institute for Occupational, Social and Environmental Medicine, Goethe University Frankfurt am Main, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Groß', 'Affiliation': 'Faculty of Health Sciences, University of Applied Sciences, Giessen, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105175']
3076,32978183,Oral health improvement for nursing home residents through delegated remotivation and reinstruction (MundZaRR Study): study protocol of a cluster-randomised controlled trial.,"INTRODUCTION


Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor. We will develop an evidence-based catalogue of interventions ('Oral Health Toolbox') and provide care-accompanying reinstruction and remotivation of nursing staff by dental assistants (DA). We hypothesise that such intervention will significantly improve OHrQL, daily oral hygiene/care behaviour and is cost-effective.
METHODS AND ANALYSIS


A scoping review will be used to identify possible intervention components. Mixed methods will be used to identify barriers and enablers of oral hygiene and care in German LRC. The result will be the 'Oral Health Toolbox', a two-phased instrument supporting both initial intervention allocation to improve oral health/hygiene and reinstruction/remotivation. A two-arm clustered, randomised controlled trial (ratio of 1:1 via block randomisation) will be performed in LRC in Rhineland-Palatinate, Germany. Each nursing home represents a cluster. Based on a feasibility study, considering clustering and possible attrition, we aim at recruiting 618 residents in 18 clusters. In the intervention group, dentists will assign one or more intervention component from the box (phase 1). During follow-up, nursing staff will be reinstructed and remotivated by DA, who use the box to decide how to maintain the intervention (phase 2). In the control group residents will receive care as usual. The primary outcome, OHrQL, will be measured using the General Oral Health Assessment Index. Secondary outcomes include pain condition, general health-related quality of life, caries increment, oral/prosthetic hygiene and gingival status, incidence of dental emergencies and hospitalisations, and cost-utility/effectiveness. The endpoints will be measured at baseline and after 12 months. For our primary outcome, a mixed-linear model will be used within an intention-to-treat analysis. A process evaluation using mixed methods will be conducted alongside the trial.
ETHICS AND DISSEMINATION


Ethical approval by the University of Kiel was granted (D480/18).
TRIAL REGISTRATION NUMBER


NCT04140929.",2020,"INTRODUCTION


Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor.","['residents in German long-term residential care (LRC', '618 residents in 18 clusters']",[],"['OHrQL, daily oral hygiene/care behaviour', 'pain condition, general health-related quality of life, caries increment, oral/prosthetic hygiene and gingival status, incidence of dental emergencies and hospitalisations, and cost-utility/effectiveness', 'Oral health improvement', 'OHrQL, will be measured using the General Oral Health Assessment Index']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",618.0,0.135337,"INTRODUCTION


Oral health and oral health-related quality of life (OHrQL) of residents in German long-term residential care (LRC) are poor.","[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Hertrampf', 'Affiliation': 'Clinic of Oral and Maxillofacial Surgery, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schlattmann', 'Affiliation': 'Medical Statistics, Computer and DataSciences, Friedrich-Schiller-Universitat Jena, Jena, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'Institute for Health Care and Nursing Studies, University Halle, Halle/Saale, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gassmann', 'Affiliation': 'praxisHochschule pHfG Trägergesellschaft, praxisHochschule University of Applied Sciences, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Abraham', 'Affiliation': 'Institute for Health Care and Nursing Studies, University Halle, Halle/Saale, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Hammen', 'Affiliation': 'praxisHochschule University of Applied Sciences, praxisHochschule University of Applied Sciences, Cologne, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Schwendicke', 'Affiliation': 'Zahnerhaltung, Charite Universitatsmediz in Berlin Campus Benjamin Franklin, Berlin, Germany falk.schwendicke@charite.de.'}]",BMJ open,['10.1136/bmjopen-2019-035999']
3077,32978185,Enhanced Recovery after Intensive Care (ERIC): study protocol for a German stepped wedge cluster randomised controlled trial to evaluate the effectiveness of a critical care telehealth program on process quality and functional outcomes.,"INTRODUCTION


Survival after critical illness has noticeably improved over the last decades due to advances in critical care medicine. Besides, there is an increasing number of elderly patients with chronic diseases being treated in the intensive care unit (ICU). More than half of the survivors of critical illness suffer from medium-term or long-term cognitive, psychological and/or physical impairments after ICU discharge, which is recognised as post-intensive care syndrome (PICS). There are evidence-based and consensus-based quality indicators (QIs) in intensive care medicine, which have a positive influence on patients' long-term outcomes if adhered to.
METHODS AND ANALYSIS


The protocol of a multicentre, pragmatic, stepped wedge cluster randomised controlled, quality improvement trial is presented. During 3 predefined steps, 12 academic hospitals in Berlin and Brandenburg, Germany, are randomly selected to move in a one-way crossover from the control to the intervention condition. After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU. The targeted sample size is 1431 patients. The primary objective of this trial is to evaluate the effectiveness of the intervention on the adherence to eight QIs daily measured during the patient's ICU stay, compared with standard of care. Furthermore, the impact on long-term recovery such as PICS-related, patient-centred outcomes including health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness 3 and 6 months after ICU discharge will be evaluated.
ETHICS AND DISSEMINATION


This protocol was approved by the ethics committee of the Charité-Universitätsmedizin, Berlin, Germany (EA1/006/18). The results will be published in a peer-reviewed scientific journal and presented at international conferences. Study findings will also be disseminated via the website (www.eric-projekt.net).
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03671447).",2020,"After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU.","['elderly patients with chronic diseases being treated in the intensive care unit (ICU', '1431 patients', '12 academic hospitals in Berlin and Brandenburg, Germany']","['multifactorial training programme', 'critical care telehealth program']","['process quality and functional outcomes', 'health-related quality of life, mental health, clinical assessments of cognition and physical function, all-cause mortality and cost-effectiveness']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.211071,"After a multifactorial training programme on QIs and clinical outcomes for site personnel, ICUs will receive an adapted, interprofessional protocol for a complex telehealth intervention comprising of daily telemedical rounds at ICU.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Adrion', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Bjoern', 'Initials': 'B', 'LastName': 'Weiss', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Paul', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Berger', 'Affiliation': 'Department of Health Care Management, Technical University of Berlin, Berlin, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Busse', 'Affiliation': 'Department of Health Care Management, Technical University of Berlin, Berlin, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Marschall', 'Affiliation': 'BARMER, Wuppertal, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Caumanns', 'Affiliation': 'Fraunhofer Institute for Open Communication Systems, Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rosseau', 'Affiliation': 'Weaning and Ventilation Centre, Ernst von Bergmann Klinikum, Bad Belzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': 'Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany claudia.spies@charite.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036096']
3078,32978188,Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial.,"INTRODUCTION


Plantar fasciitis (PF) is reported to be the most common cause of plantar heel pain. Acupuncture has been used for patients experiencing PF, but evidence of the efficacy of acupuncture on PF is limited. The primary objective of this trial is to compare combined acupuncture and sham acupuncture (SA) versus waitlist control for improving the level of pain experienced by patients suffering from chronic PF.
METHODS AND ANALYSIS


This will be a two-centre, parallel-group, sham and no-treatment controlled, assessor-blinded randomised trial. We will randomly allocate 120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1. Participants in the acupuncture and SA groups will receive a 30 min acupuncture or SA treatment for a total of 12 sessions over 4 weeks, with a 12-week follow-up. Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period. The primary outcome will be the treatment response rate 4 weeks after randomisation, assessed as a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with the baseline. All analyses will be performed with a two-sided p value of <0.05 considered significant following the intention-to-treat principle.
ETHICS AND DISSEMINATION


The study has been approved by the Ethical Committee of the Guang'anmen Hospital, China Academy of Chinese Medical Sciences (approval no. 2019-210-KY). The results will be disseminated through presentation at a peer-reviewed medical journal, the relevant conferences and scientific meetings.
TRIAL REGISTRATION


NCT04185259.",2020,Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period.,"['120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1', 'patients with chronic plantar fasciitis', 'patients suffering from chronic PF']","['Acupuncture', '30\u2009min acupuncture or SA', 'acupuncture versus sham acupuncture', 'acupuncture and sham acupuncture (SA', 'acupuncture']","['worst pain intensity', 'treatment response rate']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1136148', 'cui_str': 'Fasciitis, Plantar, Chronic'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",120.0,0.197437,Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period.,"[{'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Acupuncture and Moxibustion Department, China Academy of Traditional Chinese Medicine Guang'anmen Hospital, Xicheng District, China.""}, {'ForeName': 'Sixing', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Guizhou University of Traditional Chinese Medicine, Guiyang City, Guizhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zang', 'Affiliation': 'Department of Acupuncture, Yantai Hospital of Traditional Chinese Medicine, Yantai, China.'}, {'ForeName': 'Weina', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Acupuncture and Moxibustion Department, China Academy of Traditional Chinese Medicine Guang'anmen Hospital, Xicheng District, China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, China Academy of Chinese Medical Sciences Guanganmen Hospital, Xicheng District, Beijing, China.'}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Acupuncture and Moxibustion Department, China Academy of Traditional Chinese Medicine Guang'anmen Hospital, Xicheng District, China zhishunjournal@163.com.""}]",BMJ open,['10.1136/bmjopen-2020-036773']
3079,32978193,Cadaveric simulation versus standard training for postgraduate trauma and orthopaedic surgical trainees: protocol for the CAD:TRAUMA study multicentre randomised controlled educational trial.,"INTRODUCTION


The quantity and quality of surgical training in the UK has been negatively affected by reduced working hours and National Health Service (NHS) financial pressures. Traditionally surgical training has occurred by the master-apprentice model involving a process of graduated responsibility, but a modern alternative is to use simulation for the early stages of training. It is not known if simulation training for junior trainees can safeguard patients and improve clinical outcomes. This paper details the protocol for a multicentre randomised controlled educational trial of a cadaveric simulation training intervention versus standard training for junior postgraduate orthopaedic surgeons-in-training. This is the first study to assess the effect of cadaveric simulation training for open surgery on patient outcome. The feasibility of delivering cadaveric training, use of radiographic and clinical outcome measures to assess impact and the challenges of upscaling provision will be explored.
METHODS AND ANALYSIS


We will recruit postgraduate orthopaedic surgeons-in-training in the first 3 years (of 8) of the specialist training programme. Participants will be block randomised and allocated to either cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures, each of which is a substudy within the trial. The procedures are (1) dynamic hip screw, (2) hemiarthroplasty and (3) ankle fracture fixation. These procedures have been selected as they are very common procedures which are routinely performed by junior surgeons-in-training. A pragmatic approach to sample size is taken in lieu of a formal power calculation as this is novel exploratory work with no a priori estimate of effect size to reference. The primary outcome measure is the technical success of the surgery performed on patients by the participating surgeons-in-training during the follow-up period for the three substudy procedures, as measured by the implant position on the postoperative radiograph. The secondary outcome measures are procedure time, postoperative complication rate and patient health state at 4 months postoperation (EQ-5D-substudies 1 and 2 only).
ETHICS, REGISTRATION AND DISSEMINATION


National research ethics approval was granted for this study by the NHS Research Authority South Birmingham Research Ethics Committee (15/WM/0464). Confidentiality Advisory Group approval was granted for accessing radiographic and outcome data without patient consent on 27 February 2017 (16/CAG/0125). The results of this trial will be submitted to a peer-reviewed journal and will inform educational and clinical practice.
TRIAL REGISTRATION NUMBER


ISRCTN20431944.",2020,"Participants will be block randomised and allocated to either cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures, each of which is a substudy within the trial.","['junior postgraduate orthopaedic surgeons-in-training', 'postgraduate trauma and orthopaedic surgical trainees', 'postgraduate orthopaedic surgeons-in-training in the first 3\u2009years (of 8) of the specialist training programme']","[""cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures"", 'cadaveric simulation training intervention versus standard training', 'Cadaveric simulation versus standard training', 'cadaveric training', 'cadaveric simulation training']","['procedure time, postoperative complication rate and patient health state at 4 months postoperation (EQ-5D-substudies 1 and 2 only', 'technical success of the surgery performed on patients by the participating surgeons-in-training', 'postoperative radiograph']","[{'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0524852', 'cui_str': 'Orthopaedic procedure'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",,0.0994631,"Participants will be block randomised and allocated to either cadaveric simulation or standard 'on-the-job' training, learning three common orthopaedic procedures, each of which is a substudy within the trial.","[{'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'James', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, UK h.smith.1@warwick.ac.uk.'}, {'ForeName': 'Giles T R', 'Initials': 'GTR', 'LastName': 'Pattison', 'Affiliation': 'Trauma & Orthopaedic Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Joanne D', 'Initials': 'JD', 'LastName': 'Fisher', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, UK.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Griffin', 'Affiliation': 'Clinical Trials Unit, University of Warwick, Warwick Medical School, Coventry, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037319']
3080,32977820,"The therapeutic effects of methylphenidate and matrix-methylphenidate on addiction severity, craving, relapse and mental health in the methamphetamine use disorder.","BACKGROUND


Little evidence has examined the therapeutic effects of methylphenidate (MPH) and Matrix Model treatment on addiction severity, craving, relapse and mental health in people who use methamphetamine (PWUM). This study was conducted to determine the effects of MPH, Matrix Model treatment, and Matrix-MPH on addiction severity, craving, relapse and mental health in PWUM.
METHODS


This clinical trial was conducted among 100 patients with METH users. Participants were randomly divided into four groups who received: 1) 22 sessions of 45-min, twice a week for Matrix Model treatment (n = 25); 2) MPH 10 mg/day in the first month, 7.5 mg/day in the second month and 5 mg/day in the third month (n = 25); 3) Matrix Model treatment combined with MPH (n = 25); 4) control group (n = 25) for 12 weeks. Addiction severity, craving, relapse and mental status were evaluated at baseline and end-of-trial.
RESULTS


Matrix Model treatment combined with MPH significantly reduced MA craving (P < 0.001) and addiction severity (P < 0.001). In addition, Matrix Model treatment combined with MPH resulted in a significant increase of mental health (P = 0.001), compared with Matrix Model treatment, MPH, and control group. Also, negative METH urine test significantly increased in the Matrix Model treatment combined with MPH group compared with the other groups (P < 0.001).
CONCLUSIONS


In conclusion, Matrix Model treatment combined with MPH for 12 weeks had beneficial effects on addiction severity, craving, relapse, and mental health in PWUM, compared with Matrix Model treatment, MPH, and control group.
TRIAL REGISTRATION


This study was retrospectively registered in the Iranian website ( www.irct.ir ) for clinical trials registration ( http://www.irct.ir : IRCT20171105037245N1 ). Registration date: 9 December 2017.",2020,"RESULTS


Matrix Model treatment combined with MPH significantly reduced MA craving (P < 0.001) and addiction severity (P < 0.001).","['people who use methamphetamine (PWUM', '100 patients with METH users']","['methylphenidate and matrix-methylphenidate', 'Matrix Model treatment', 'Matrix Model treatment combined with MPH', 'methylphenidate (MPH) and Matrix Model treatment']","['addiction severity, craving, relapse, and mental health in PWUM', 'mental health', 'addiction severity', 'negative METH urine test', 'MA craving', 'addiction severity, craving, relapse and mental health', 'Addiction severity, craving, relapse and mental status']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2188866', 'cui_str': 'History of methamphetamine abuse'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2188866', 'cui_str': 'History of methamphetamine abuse'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}]",100.0,0.0563746,"RESULTS


Matrix Model treatment combined with MPH significantly reduced MA craving (P < 0.001) and addiction severity (P < 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Aryan', 'Affiliation': 'Department of Addiction studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Banafshe', 'Affiliation': 'Department of Addiction studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Farnia', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Shakeri', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Alikhani', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Rahimi', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Sehat', 'Affiliation': 'Department of Community Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Mamsharifi', 'Affiliation': ""Department of Psychology, Allameh Tabataba'i University, Tehran, Iran.""}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Addiction studies, School of Medical, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Omidi', 'Affiliation': 'Department of clinical psychology, School of Medicine, Kashan University of Medical Science, Kashan, Iran. abomidi20@yahoo.com.'}]","Substance abuse treatment, prevention, and policy",['10.1186/s13011-020-00317-y']
3081,32977831,Effects of empagliflozin versus placebo on cardiac sympathetic activity in acute myocardial infarction patients with type 2 diabetes mellitus: the EMBODY trial.,"BACKGROUND


Protection from lethal ventricular arrhythmias leading to sudden cardiac death (SCD) is a crucial challenge after acute myocardial infarction (AMI). Cardiac sympathetic and parasympathetic activity can be noninvasively assessed using heart rate variability (HRV) and heart rate turbulence (HRT). The EMBODY trial was designed to determine whether the Sodium-glucose cotransporter 2 (SGLT2) inhibitor improves cardiac nerve activity.
METHODS


This prospective, multicenter, randomized, double-blind, placebo-controlled trial included patients with AMI and type 2 diabetes mellitus (T2DM) in Japan; 105 patients were randomized (1:1) to receive once-daily 10-mg empagliflozin or placebo. The primary endpoints were changes in HRV, e.g., the standard deviation of all 5-min mean normal RR intervals (SDANN) and the low-frequency-to-high-frequency (LF/HF) ratio from baseline to 24 weeks. Secondary endpoints were changes in other sudden cardiac death (SCD) surrogate markers such as HRT.
RESULTS


Overall, 96 patients were included (46, empagliflozin group; 50, placebo group). The changes in SDANN were + 11.6 and + 9.1 ms in the empagliflozin (P = 0.02) and placebo groups (P = 0.06), respectively. Change in LF/HF ratio was - 0.57 and - 0.17 in the empagliflozin (P = 0.01) and placebo groups (P = 0.43), respectively. Significant improvement was noted in HRT only in the empagliflozin group (P = 0.01). Whereas intergroup comparison on HRV and HRT showed no significant difference between the empagliflozin and placebo groups. Compared with the placebo group, the empagliflozin group showed significant decreases in body weight, systolic blood pressure, and uric acid. In the empagliflozin group, no adverse events were observed.
CONCLUSIONS


This is the first randomized clinical data to evaluate the effect of empagliflozin on cardiac sympathetic and parasympathetic activity in patients with T2DM and AMI. Early SGLT2 inhibitor administration in AMI patients with T2DM might be effective in improving cardiac nerve activity without any adverse events.
TRIAL REGISTRATION


The EMBODY trial was registered by the UMIN in November 2017 (ID: 000030158). UMIN000030158; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034442 .",2020,Whereas intergroup comparison on HRV and HRT showed no significant difference between the empagliflozin and placebo groups.,"['patients with T2DM and AMI', 'patients with AMI and type 2 diabetes mellitus (T2DM) in Japan; 105 patients', '96 patients were included (46, empagliflozin group; 50, placebo group', 'acute myocardial infarction patients with type 2 diabetes mellitus', 'AMI patients with T2DM']","['Sodium-glucose cotransporter 2 (SGLT2) inhibitor', 'empagliflozin or placebo', 'empagliflozin', 'placebo']","['heart rate variability (HRV) and heart rate turbulence (HRT', 'cardiac sympathetic and parasympathetic activity', 'body weight, systolic blood pressure, and uric acid', 'adverse events', 'cardiac sympathetic activity', 'HRT', 'HRV and HRT', 'sudden cardiac death (SCD) surrogate markers such as HRT', 'Change in LF/HF ratio', 'changes in HRV, e.g., the standard deviation of all 5-min mean normal RR intervals (SDANN) and the low-frequency-to-high-frequency (LF/HF) ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0086589', 'cui_str': 'Marker, Surrogate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",96.0,0.425435,Whereas intergroup comparison on HRV and HRT showed no significant difference between the empagliflozin and placebo groups.,"[{'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Shimizu', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan. wshimizu@nms.ac.jp.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Kubota', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hoshika', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Mozawa', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Tara', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Yukichi', 'Initials': 'Y', 'LastName': 'Tokita', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yodogawa', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Yu-Ki', 'Initials': 'YK', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Takano', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Yayoi', 'Initials': 'Y', 'LastName': 'Tsukada', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Kuniya', 'Initials': 'K', 'LastName': 'Asai', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-0022, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School Chiba Hokuso Hospital, Chiba, Japan.'}, {'ForeName': 'Eitaro', 'Initials': 'E', 'LastName': 'Kodani', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon Medical School Tama Nagayama Hospital, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon MEDICAL School Musashi Kosugi Hospital, Tokyo, Japan.'}, {'ForeName': 'Mitsunori', 'Initials': 'M', 'LastName': 'Maruyama', 'Affiliation': 'Department of Cardiovascular Medicine, Nippon MEDICAL School Musashi Kosugi Hospital, Tokyo, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Ogano', 'Affiliation': 'Department of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tanabe', 'Affiliation': 'Department of Cardiovascular Medicine, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular diabetology,['10.1186/s12933-020-01127-z']
3082,32977975,Multimodal analgesia after thyroid or parathyroid surgery: A randomized controlled trial.,"BACKGROUND


The opioid epidemic prompted reevaluation of surgeons' opioid prescribing practices. This study aimed to demonstrate noninferiority of a staged analgesic regimen after endocrine surgery.
METHODS


We conducted a randomized controlled trial comparing analgesic regimens after thyroidectomy and/or parathyroidectomy. Adult patients (≥18 years) were randomized to study arm (A) as-needed acetaminophen + codeine or (B) scheduled acetaminophen/as-needed tramadol. Patients recorded pain scores and analgesics consumed in a study log. Clinical variables were collected from the medical record.
RESULTS


Target enrollment was achieved (n = 126), and randomization was even (A: 44.5%, B: 55.6%). There was no difference between enrolled patients and those who returned the study log (52.4%) by sex (P = .667), age (P = .513), final pathology (P = .137), procedure (P = .667), or randomization arm (P = .795). Most patients (50.8%) reported moderate pain scores (4-6) with no difference between study arms (P = .451). There was no difference in average consumption by morphine milligram equivalents (A: 11.5 ± 12.1 vs B: 12.49 ± 18.07; P = .792) nor total analgesic doses (A: 7.29 ± 7.48 vs B: 8.5 ± 5.36; P = .445). However, a significant difference in average percentage of opioid doses was noted (A: 79.71 ± 33.31 vs B: 27.38 ± 31.88; P < .001).
CONCLUSION


Patients reported moderate pain scores with low requirements for analgesics after endocrine surgery. The staged analgesic regimen is noninferior to combination opioids and led to reduced overall consumption.",2020,Most patients (50.8%) reported moderate pain scores (4-6) with no difference between study arms (P = .451).,['Adult patients (≥18 years'],"['acetaminophen\xa0+ codeine or (B) scheduled acetaminophen/as-needed tramadol', 'thyroidectomy and/or parathyroidectomy', 'Multimodal analgesia after thyroid or parathyroid surgery']","['average consumption by morphine milligram equivalents', 'average percentage of opioid doses', 'moderate pain scores', 'pain scores and analgesics', 'total analgesic doses']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2351132', 'cui_str': 'codeine and paracetamol'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0079989', 'cui_str': 'Parathyroidectomy'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.466354,Most patients (50.8%) reported moderate pain scores (4-6) with no difference between study arms (P = .451).,"[{'ForeName': 'Minerva A', 'Initials': 'MA', 'LastName': 'Romero Arenas', 'Affiliation': 'Department of Surgery, School of Medicine, University of Texas Rio Grande Valley, Edinburg, TX. Electronic address: minerva.romeroarenas@utrgv.edu.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Uhlmann', 'Affiliation': 'Department of Surgery, School of Medicine, University of Texas Rio Grande Valley, Edinburg, TX.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Postevka', 'Affiliation': 'School of Medicine, University of Texas Rio Grande Valley, Edinburg, TX.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Mathematical and Statistical Sciences, University of Texas Rio Grande Valley, Edinburg, TX.'}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Reinhart', 'Affiliation': 'Department of Surgery, School of Medicine, University of Texas Rio Grande Valley, Edinburg, TX.'}, {'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Snyder', 'Affiliation': 'Department of Surgery, School of Medicine, University of Texas Rio Grande Valley, Edinburg, TX.'}]",Surgery,['10.1016/j.surg.2020.08.008']
3083,32978021,Biomechanical Study of Patellar Component Fixation with Varying Degrees of Bone Loss.,"BACKGROUND


The decision as to whether or not to resurface the patella in revision total knee arthroplasty (TKA) is affected by the amount of patellar bone stock remaining; however, the impact of the cancellous bone status on patellar component fixation has not been studied. Therefore, we conducted a biomechanical study of patellar component fixation with varying degrees of cancellous bone loss.
METHODS


Sixty pairs of cadaveric patellae were randomly assigned between 3 groups and prepared in similar manner to a TKA with the standard 3-hole configuration. A control patella and an experimental patella were designated in each pair. To simulate bone loss in the experimental patellae, 1, 2, and 3 of the standard drill holes were uniformly enlarged to 12 mm in group 1, group 2, and group 3, respectively. Afterward, an all-polyethylene patellar component was cemented to each patella, as done intraoperatively. Patellar components were then sheared off using a materials testing system. The resulting mean offset yield force was analyzed within each group using paired t-tests.
RESULTS


The mean offset yield force for the control patellae was greater than the experimental patellae in group 1. In groups 2 and 3, the experimental patellae produced a greater mean offset yield force than the control patellae. Comparison within each group did not demonstrate a statistically significant difference.
CONCLUSION


Bone loss with enlargement of the patellar fixation holes, as is frequently seen in revision TKA, with holes up to 12 mm, does not significantly decrease patellar component fixation shear strength in this biomechanical cadaveric study.",2020,"In groups 2 and 3, the experimental patellae produced a greater mean offset yield force than the control patellae.",['Sixty pairs of cadaveric patellae'],"['TKA with the standard 3-hole configuration', 'Patellar Component Fixation with Varying Degrees of Bone Loss', 'patellar component fixation']",['patellar component fixation shear strength'],[],"[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0449352', 'cui_str': 'Patellar component fixation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]","[{'cui': 'C0449352', 'cui_str': 'Patellar component fixation'}, {'cui': 'C1135950', 'cui_str': 'Shear Strength'}]",60.0,0.0319916,"In groups 2 and 3, the experimental patellae produced a greater mean offset yield force than the control patellae.","[{'ForeName': 'Cameron M', 'Initials': 'CM', 'LastName': 'Beck', 'Affiliation': 'Texas College of Osteopathic Medicine, University of North Texas Health Science Center, Fort Worth, TX.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Nwannunu', 'Affiliation': 'Department of Orthopaedic Surgery, John Peter Smith Hospital, Fort Worth, TX.'}, {'ForeName': 'Kari J', 'Initials': 'KJ', 'LastName': 'Teigen', 'Affiliation': 'Office of Clinical Research, John Peter Smith Hospital, Fort Worth, TX.'}, {'ForeName': 'Russell A', 'Initials': 'RA', 'LastName': 'Wagner', 'Affiliation': 'Texas College of Osteopathic Medicine, University of North Texas Health Science Center, Fort Worth, TX; Department of Orthopaedic Surgery, John Peter Smith Hospital, Fort Worth, TX.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.08.044']
3084,32978029,Static Ultrasound Guidance VS. Anatomical Landmarks for Subclavian Vein Puncture in the Intensive Care Unit: A Pilot Randomized Controlled Study.,"BACKGROUND


Subclavian vein puncture is commonly used in the intensive care unit (ICU) but is associated with complications.
OBJECTIVE


Our aim was to compare the efficacy and safety of static ultrasound-guided subclavian vein puncture with traditional anatomical landmark-guided subclavian vein puncture in critically ill patients in the ICU.
METHODS


This pilot randomized controlled trial enrolled patients admitted to the ICU and requiring subclavian vein puncture between November 2017 and September 2018. The patients were randomized to ultrasound-guided puncture or anatomical landmark-guided puncture. The primary outcome measure was the puncture success rate. The secondary outcome measures included the number of punctures, rate of success at the first attempt, puncture time (i.e., procedure duration) and incidence of complications.
RESULTS


A total of 194 patients were included in the analyses. Compared with the anatomical landmarks group, the ultrasound group had a higher puncture success rate (91.7% vs. 77.6%; p = 0.007), lower rate of complications (7.3% vs. 20.4%; p = 0.008), and lower incidence of mispuncture of an artery (2.1% vs. 14.3%; p = 0.002). There were no significant differences in the number of punctures and puncture time between the two groups (both, p > 0.05).
CONCLUSIONS


Static ultrasound-guided subclavian vein puncture is superior to the traditional landmark-guided approach for critically ill patients in the ICU. It is suggested that static ultrasound-guided puncture techniques should be considered for subclavian vein puncture in the ICU.
TRIAL REGISTRATION


ChiCTR1900024051.",2020,"There were no significant differences in the number of punctures and puncture time between the two groups (both, p > 0.05).
","['A total of 194 patients were included in the analyses', 'enrolled patients admitted to the ICU and requiring subclavian vein puncture between November 2017 and September 2018', 'critically ill patients in the ICU', 'Intensive Care Unit']","['Static Ultrasound Guidance VS', 'Static ultrasound-guided subclavian vein puncture', 'static ultrasound-guided subclavian vein puncture with traditional anatomical landmark-guided subclavian vein puncture', 'ultrasound-guided puncture or anatomical landmark-guided puncture']","['efficacy and safety', 'puncture success rate', 'number of punctures, rate of success at the first attempt, puncture time (i.e., procedure duration) and incidence of complications', 'number of punctures and puncture time', 'rate of complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",194.0,0.120026,"There were no significant differences in the number of punctures and puncture time between the two groups (both, p > 0.05).
","[{'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Jiming', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}, {'ForeName': 'Shaoyi', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Intensive Care Unit, Second Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, China.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.07.039']
3085,32978034,Neurocognitive and social cognitive training for youth at clinical high risk (CHR) for psychosis: A randomized controlled feasibility trial.,"BACKGROUND


Cognitive deficits are present in individuals at clinical high risk for psychosis (CHRP). We developed Cognition for Learning and for Understanding Everyday Social Situations (CLUES), an integrated social- and neurocognitive remediation intervention for CHRP, and examined its feasibility and efficacy compared to an active control intervention in a pilot randomized controlled trial.
METHOD


Thirty-eight individuals at CHR-P were randomized to CLUES or Enriched Acceptance and Commitment Therapy (EnACT). Participants were assessed at baseline, end of treatment and 3-month follow-up for changes in social/role functioning, neuro- and social cognition, and symptoms.
RESULTS


Social functioning significantly improved for participants in CLUES over EnACT, at end of treatment and 3-month follow-up. CLUES participants also showed greater improvements in social cognition (theory of mind and managing emotions).
CONCLUSION


The results support feasibility of CLUES and suggest preliminary efficacy. Future randomized controlled trials of CLUES in a larger sample, with additional treatment sites, could help determine efficacy of CLUES, and investigate whether CLUES can be effectively implemented in other settings.",2020,"Participants were assessed at baseline, end of treatment and 3-month follow-up for changes in social/role functioning, neuro- and social cognition, and symptoms.
","['Thirty-eight individuals at CHR-P', 'individuals at clinical high risk for psychosis (CHRP', 'youth at clinical high risk (CHR) for psychosis']","['CLUES', 'CLUES or Enriched Acceptance and Commitment Therapy (EnACT', 'Neurocognitive and social cognitive training']","['social cognition (theory of mind and managing emotions', 'Social functioning', 'social/role functioning, neuro- and social cognition, and symptoms']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043459', 'cui_str': 'Zellweger syndrome'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0772979,"Participants were assessed at baseline, end of treatment and 3-month follow-up for changes in social/role functioning, neuro- and social cognition, and symptoms.
","[{'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Friedman-Yakoobian', 'Affiliation': 'Public Psychiatry Division of Department of Psychiatry, Harvard Medical School at Beth Israel Deaconess Medical Center, 75 Fenwood Road, Boston, MA 02115, United States of America. Electronic address: mfriedm3@bidmc.harvard.edu.'}, {'ForeName': 'Emma M', 'Initials': 'EM', 'LastName': 'Parrish', 'Affiliation': 'Public Psychiatry Division of Department of Psychiatry, Harvard Medical School at Beth Israel Deaconess Medical Center, 75 Fenwood Road, Boston, MA 02115, United States of America.'}, {'ForeName': 'Shaun M', 'Initials': 'SM', 'LastName': 'Eack', 'Affiliation': 'University of Pittsburgh, School of Social Work and Department of Psychiatry, United States of America.'}, {'ForeName': 'Matcheri S', 'Initials': 'MS', 'LastName': 'Keshavan', 'Affiliation': 'Public Psychiatry Division of Department of Psychiatry, Harvard Medical School at Beth Israel Deaconess Medical Center, 75 Fenwood Road, Boston, MA 02115, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2020.09.005']
3086,32978042,Effects of cycle periods and pressure amplitudes of alternating pressure on sacral skin blood flow responses.,"BACKGROUND


There are no guidelines on selecting alternating pressure (AP) configurations on increasing sacral skin blood flow (SBF).
AIM


The specific aims were to compare different cycle periods and pressure amplitudes of AP on sacral SBF responses in healthy people to establish the efficacy and safety of the protocols.
METHODS


Two studies were tested, including the cycle period study (8 2.5-min vs 4 5-min protocols) and the pressure amplitude study (75/5 vs 65/15 mmHg protocols). Sacral SBF was measured using laser Doppler flowmetry (LDF) in 20 participants. AP loads were randomly applied using an indenter through the rigid LDF probe. Each protocol included a 10-min baseline, 20-min AP and 10-min recovery periods. A 30-min washout period was provided. The SBF response was normalized to the baseline SBF of each condition of each participant.
RESULTS


For the cycle period study, the 4 5-min cycle protocol partially restored more SBF than the 8 2.5-min cycle protocol at the low-pressure phase (0.87 ± 0.04 vs 0.71 ± 0.03, p < 0.05) and at the high-pressure phase (0.25 ± 0.03 vs 0.19 ± 0.03, p < 0.05). For the pressure amplitude study, the 75/5 mmHg protocol partially restored more sacral SBF than the 65/15 mmHg protocol at the low-pressure phase (0.87 ± 0.1 vs 0.25 ± 0.03, p < 0.05) but not at the high-pressure phase (0.23 ± 0.02 vs 0.21 ± 0.02, non-significant).
CONCLUSION


This study demonstrated that 1) a cycle period of 5 min was better than 2.5 min and 2) a pressure amplitude of 75/5 mmHg was better than 65/15 mmHg. The finding provides insights for selecting the AP configurations for increasing SBF.",2020,"For the pressure amplitude study, the 75/5 mmHg protocol partially restored more sacral SBF than the 65/15 mmHg protocol at the low-pressure phase (0.87 ± 0.1 vs 0.25 ± 0.03, p < 0.05) but not at the high-pressure phase (0.23 ± 0.02 vs 0.21 ± 0.02, non-significant).
","['healthy people', '20 participants']",['laser Doppler flowmetry (LDF'],"['Sacral SBF', 'sacral SBF', 'sacral skin blood flow responses', 'sacral SBF responses', 'SBF', 'SBF response', 'sacral skin blood flow (SBF']","[{'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}]","[{'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",20.0,0.0371937,"For the pressure amplitude study, the 75/5 mmHg protocol partially restored more sacral SBF than the 65/15 mmHg protocol at the low-pressure phase (0.87 ± 0.1 vs 0.25 ± 0.03, p < 0.05) but not at the high-pressure phase (0.23 ± 0.02 vs 0.21 ± 0.02, non-significant).
","[{'ForeName': 'Fu-Lien', 'Initials': 'FL', 'LastName': 'Wu', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Champaign, IL, USA.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Champaign, IL, USA.'}, {'ForeName': 'Yinyin', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Champaign, IL, USA.'}, {'ForeName': 'Kaixiang', 'Initials': 'K', 'LastName': 'Weng', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Champaign, IL, USA.'}, {'ForeName': 'Fuyuan', 'Initials': 'F', 'LastName': 'Liao', 'Affiliation': ""Department of Biomedical Engineering, Xi'an Technological University, Xi'an, China.""}, {'ForeName': 'Yih-Kuen', 'Initials': 'YK', 'LastName': 'Jan', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Champaign, IL, USA. Electronic address: yjan@illinois.edu.'}]",Journal of tissue viability,['10.1016/j.jtv.2020.09.004']
3087,32978076,Efficacy of clarithromycin-naproxen-oseltamivir combination therapy versus oseltamivir alone in hospitalized pediatric influenza patients.,"PURPOSE


This study aimed to compare the safety and efficacy of clarithromycin-naproxen-oseltamivir combination therapy to that of oseltamivir therapy alone in hospitalized pediatric influenza patients.
METHODS


This prospective, single-blind study included children aged 1-18 years hospitalized with influenza, in MacKay Children's Hospital, Taiwan, between December 2017 and December 2019. The primary outcomes were the time to defervescence and decrease of the Pediatric Respiratory Severity Score (PRESS) during hospitalization. The secondary outcomes were serial changes in virus titers, measured using real-time polymerase chain reaction.
RESULTS


Fifty-four patients were enrolled (28 in the control group and 26 in the combination group) in total. There were no differences in the patients' baseline characteristics between the groups. The time to defervescence was significantly shorter in the combination group than the oseltamivir group (13.2 h vs. 32.1 h, p = 0.002). The decrease in the virus titer from days 1-3 (log Δ13) was more pronounced in the combination group than the oseltamivir group. (39% vs. 19%, p = 0.001). There were no differences in adverse effects such as vomiting, diarrhea, and abdominal pain during the study or within 30 days after antiviral therapy.
CONCLUSION


The clarithromycin-naproxen-oseltamivir combination group experienced a more rapid defervescence and a more rapid decline of influenza virus titer than the group treated with oseltamivir alone. Further consideration should be given to whether the overall benefits of combination therapy in hospitalized pediatric influenza patients outweigh the risks.",2020,"There were no differences in adverse effects such as vomiting, diarrhea, and abdominal pain during the study or within 30 days after antiviral therapy.
","[""children aged 1-18 years hospitalized with influenza, in MacKay Children's Hospital, Taiwan, between December 2017 and December 2019"", 'Fifty-four patients were enrolled (28 in the control group and 26 in the combination group) in total', 'hospitalized pediatric influenza patients']","['clarithromycin-naproxen-oseltamivir combination', 'oseltamivir alone', 'clarithromycin-naproxen-oseltamivir combination therapy']","['rapid defervescence', 'influenza virus titer', 'safety and efficacy', 'serial changes in virus titers, measured using real-time polymerase chain reaction', 'virus titer', 'adverse effects such as vomiting, diarrhea, and abdominal pain', 'time to defervescence', 'time to defervescence and decrease of the Pediatric Respiratory Severity Score (PRESS) during hospitalization']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0027396', 'cui_str': 'Naproxen'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0029341', 'cui_str': 'Family Orthomyxoviridae'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2713348', 'cui_str': 'Virus Titer'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",54.0,0.0435659,"There were no differences in adverse effects such as vomiting, diarrhea, and abdominal pain during the study or within 30 days after antiviral therapy.
","[{'ForeName': 'Chien-Wei', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': ""Department of Pediatric Infectious Diseases, MacKay Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Yu-Lin', 'Initials': 'YL', 'LastName': 'Tai', 'Affiliation': ""Department of Pediatric Infectious Diseases, MacKay Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Li-Min', 'Initials': 'LM', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics Infectious Diseases, National Taiwan University Hospital, Taiwan.'}, {'ForeName': 'Hsin', 'Initials': 'H', 'LastName': 'Chi', 'Affiliation': ""Department of Pediatric Infectious Diseases, MacKay Children's Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medicine College, New Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.""}, {'ForeName': 'Fu-Yuan', 'Initials': 'FY', 'LastName': 'Huang', 'Affiliation': ""Department of Pediatric Infectious Diseases, MacKay Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Nan-Chang', 'Initials': 'NC', 'LastName': 'Chiu', 'Affiliation': ""Department of Pediatric Infectious Diseases, MacKay Children's Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.""}, {'ForeName': 'Ching-Ying', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': ""Department of Pediatric Infectious Diseases, MacKay Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Yi-Hsuan', 'Initials': 'YH', 'LastName': 'Tu', 'Affiliation': 'Taiwan Digital Healthcare Association.'}, {'ForeName': 'Jin-Yuan', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatric Infectious Diseases, MacKay Children's Hospital, Taipei, Taiwan.""}, {'ForeName': 'Daniel Tsung-Ning', 'Initials': 'DT', 'LastName': 'Huang', 'Affiliation': ""Department of Pediatric Infectious Diseases, MacKay Children's Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medicine College, New Taipei, Taiwan; Taiwan Digital Healthcare Association. Electronic address: zoning12huang@gmail.com.""}]","Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi",['10.1016/j.jmii.2020.08.017']
3088,32978352,"Post-operative pain after laparoscopic ventral hernia repair, the impact of mesh soakage with bupivacaine solution versus normal saline solution: A randomised controlled trial (HAPPIEST Trial).","Background and Aims


Early postoperative pain after laparoscopic ventral hernia repair remains a concern for patients. Local application of anaesthetic agent in the surgical dissection area can potentially overcome this problem. The objective of this study was to evaluate the impact of soaking mesh in 0.5% bupivacaine solution as compared to normal saline solution on the post-operative pain.
Methodology


We conducted a parallel-design double-blind randomised controlled trial. Adult patients with uncomplicated ventral abdominal wall hernias were included in the trial. Mesh was soaked in 0.5% solution of bupivacaine before application in patients in the intervention arm, whereas it was soaked in normal saline solution for patients in the control arm. Post-operative pain was assessed by trained staff at 6 h and 24 h from surgery. It was graded on visual analogue scale (VAS) from 0 to 10.
Results


Trial was conducted from 16 November, 2015, to 15 September, 2017. During the study period, a total of 114 patients were randomised. Nine patients were excluded after randomisation. A total of 55 patients were analysed in the intervention arm and 50 patients were analysed in the control arm. Mean pain score at VAS at 6 h after laparoscopic ventral hernia repair in the intervention arm was 5.05 ± 1.2, whereas in the control arm, it was 5.54 ± 1.1 and the difference was statistically significant (P = 0.03-independent sample t-test). Mean pain score at VAS at 24 h after laparoscopic ventral hernia repair in the intervention arm was 3.16 ± 1.2, whereas in the control arm, it was 3.58 ± 1.4 and the difference was not statistically significant (P = 0.11-independent sample t-test).
Conclusion


Soakage of mesh in 0.5% bupivacaine solution before application in laparoscopic ventral hernia repair significantly reduces early post-operative pain.
Trial Registration


Trial was registered with clinicaltrials. gov (NCT03035617)URL: https://clinicaltrials. gov.",2020,"Mean pain score at VAS at 6 h after laparoscopic ventral hernia repair in the intervention arm was 5.05 ± 1.2, whereas in the control arm, it was 5.54 ± 1.1 and the difference was statistically significant (P = 0.03-independent sample t-test).","['114 patients were randomised', 'Adult patients with uncomplicated ventral abdominal wall hernias', 'A total of 55 patients were analysed in the intervention arm and 50 patients were analysed in the control arm', '16 November, 2015, to 15 September, 2017', 'patients']","['bupivacaine', 'bupivacaine solution versus normal saline solution', 'laparoscopic ventral hernia repair', 'bupivacaine solution', 'normal saline solution']","['visual analogue scale (VAS', 'Mean pain score', 'Post-operative pain']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0019326', 'cui_str': 'Hernia of anterior abdominal wall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",114.0,0.724817,"Mean pain score at VAS at 6 h after laparoscopic ventral hernia repair in the intervention arm was 5.05 ± 1.2, whereas in the control arm, it was 5.54 ± 1.1 and the difference was statistically significant (P = 0.03-independent sample t-test).","[{'ForeName': 'Tabish', 'Initials': 'T', 'LastName': 'Chawla', 'Affiliation': 'Department of Surgery, Aga Khan University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Noman', 'Initials': 'N', 'LastName': 'Shahzad', 'Affiliation': 'Department of Surgery, Queen Elizabeth the Queen Mother Hospital, East Kent Hospitals University NHS Foundation Trust, United Kingdom.'}, {'ForeName': 'Khabir', 'Initials': 'K', 'LastName': 'Ahmad', 'Affiliation': 'Department of Surgery, Aga Khan University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Jehangir Farman', 'Initials': 'JF', 'LastName': 'Ali', 'Affiliation': 'Department of Surgery, Aga Khan University Hospital, Karachi, Pakistan.'}]",Journal of minimal access surgery,['10.4103/jmas.JMAS_50_19']
3089,32978424,Comparison of gut microbiota in exclusively breast-fed and formula-fed babies: a study of 91 term infants.,"To compare gut microbiota of healthy infants that were exclusively breast-fed or formula-fed, we recruited 91 infants, who were assigned into three different groups and fed by breast milk (30 babies), formula A (30 babies) or formula B (31 babies) exclusively for more than 4 months after birth. Faecal bacterial composition was tested. Among different groups, α diversity was lower in breast-fed group than formula-fed groups in 40 days of age, but increased significantly in 6 months of age. The Bifidobacterium represented the most predominant genus and Enterobacteriaceae the second in all groups. In 40 days of age, Bifidobacterium and Bacteroides were significantly higher, while Streptococcus and Enterococcus were significantly lower in breast-fed group than they were in formula A-fed group. Lachnospiraceae was lower in breast-fed than formula B-fed group. Veillonella and Clostridioides were lower in breast-fed than formula-fed groups. In 3 months of age there were less Lachnospiraceae and Clostridioides in breast-fed group than formula-fed groups. There were also significant differences of microbiota between formula A-fed and formula B-fed groups. Those differences may have impacts on their long-term health.",2020,In 3 months of age there were less Lachnospiraceae and Clostridioides in breast-fed group than formula-fed groups.,"['91 term infants', 'gut microbiota in exclusively breast-fed and formula-fed babies', 'healthy infants that were exclusively breast-fed or formula-fed, we recruited 91 infants']",[],"['α diversity', 'Faecal bacterial composition', 'Lachnospiraceae', 'Veillonella and Clostridioides', 'Bifidobacterium and Bacteroides', 'Lachnospiraceae and Clostridioides']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1210564', 'cui_str': 'Lachnospiraceae'}, {'cui': 'C0042446', 'cui_str': 'Veillonella'}, {'cui': 'C4406271', 'cui_str': 'Genus Clostridioides'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]",91.0,0.0273905,In 3 months of age there were less Lachnospiraceae and Clostridioides in breast-fed group than formula-fed groups.,"[{'ForeName': 'Jingran', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Paediatrics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Paediatrics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China. worldlizhengh@outlook.com.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Inner Mongolia People's Hospital, Hohhot, 010010, China.""}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Inner Mongolia People's Hospital, Hohhot, 010010, China.""}, {'ForeName': 'Yuheng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Department of Neonatology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhuo', 'Affiliation': 'Department of Neonatology, Inner Mongolia Maternal and Child Health Hospital, Hohhot, 010020, China.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Neonatology, Inner Mongolia Maternal and Child Health Hospital, Hohhot, 010020, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Paediatrics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Neonatology, Inner Mongolia People's Hospital, Hohhot, 010010, China.""}]",Scientific reports,['10.1038/s41598-020-72635-x']
3090,32978449,Heterogeneous ozone effects on the DNA methylome of bronchial cells observed in a crossover study.,"We used a randomized crossover experiment to estimate the effects of ozone (vs. clean air) exposure on genome-wide DNA methylation of target bronchial epithelial cells, using 17 volunteers, each randomly exposed on two separated occasions to clean air or 0.3-ppm ozone for two hours. Twenty-four hours after exposure, participants underwent bronchoscopy to collect epithelial cells whose DNA methylation was measured using the Illumina 450 K platform. We performed global and regional tests examining the ozone versus clean air effect on the DNA methylome and calculated Fisher-exact p-values for a series of univariate tests. We found little evidence of an overall effect of ozone on the DNA methylome but some suggestive changes in PLSCR1, HCAR1, and LINC00336 DNA methylation after ozone exposure relative to clean air. We observed some participant-to-participant heterogeneity in ozone responses.",2020,"We found little evidence of an overall effect of ozone on the DNA methylome but some suggestive changes in PLSCR1, HCAR1, and LINC00336 DNA methylation after ozone exposure relative to clean air.",['17 volunteers'],['ozone (vs. clean air) exposure'],['DNA methylome of bronchial cells'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C4727083', 'cui_str': 'Methylome'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.0178241,"We found little evidence of an overall effect of ozone on the DNA methylome but some suggestive changes in PLSCR1, HCAR1, and LINC00336 DNA methylation after ozone exposure relative to clean air.","[{'ForeName': 'M-A C', 'Initials': 'MC', 'LastName': 'Bind', 'Affiliation': 'Department of Statistics, Faculty of Arts and Sciences, Harvard University, Cambridge, MA, USA. ma.bind@mail.harvard.edu.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Rubin', 'Affiliation': 'Yau Center for Mathematical Sciences, Tsinghua University, Beijing, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cardenas', 'Affiliation': 'Department of Environmental Health Sciences, UC Berkeley School of Public Health, Berkeley, CA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dhingra', 'Affiliation': 'Department of Environmental Sciences and Engineering, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ward-Caviness', 'Affiliation': 'Environmental Public Health Division, NHEERL, US Environmental Protection Agency, Research Triangle Park, NC, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Statistics and Actuarial Sciences, University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mirowsky', 'Affiliation': 'Department of Chemistry, SUNY College of Environmental Science and Forestry, Syracuse, NY, USA.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Schwartz', 'Affiliation': 'Department of Environmental Health, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Diaz-Sanchez', 'Affiliation': 'Environmental Public Health Division, NHEERL, US Environmental Protection Agency, Research Triangle Park, NC, USA.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Devlin', 'Affiliation': 'Environmental Public Health Division, NHEERL, US Environmental Protection Agency, Research Triangle Park, NC, USA.'}]",Scientific reports,['10.1038/s41598-020-72068-6']
3091,32978537,Effect of implant rehabilitation on oral health-related quality of life with three different implant strategies.,"Design Non-randomised controlled trial.Case selection Patients requiring dental implants were recruited from a private dental surgery in Spain. According to the clinical diagnosis and patient preference, patients were assigned to one of the following three treatment protocols: the conventional treatment (CGCL), in which implants were inserted after flap elevation without guiding templates; the guided surgery/conventional loading group (GSCL); and the guided surgery/immediate loading group (GSIL).Data analysis An oral examination and a questionnaire-based interview were carried out at baseline and three months after the delivery of the definitive prosthetic rehabilitation. Two complementary indicators, Oral Impacts on Daily Performances (OIDP) and Oral Satisfaction Scale (OSS) were used to assess the changes in oral health-related quality of life (OHQoL). Paired t-tests were used to compare the within-subject change scores. ANOVA tests were used to compare quantitative variables between groups. Chi-square tests were used to compare the distribution of data between groups. Effect size was used to assess the relative responsiveness of different health indicators and to compare the amount of change resulting from different treatment protocols. A forward stepwise logistic regression analysis was performed to predict the risk of having impact after treatment.Results A total of 104 patients were recruited: CGCL (n = 40), GSCL (n = 35) and GSIL (n = 29). At baseline, the OHQoL was significantly greater among those assigned to CGCL (2.4 ± 1.3) than those assigned to GSCL (3.3 ± 1.3), which were both greater than those patients assigned to GSIL (4.6 ± 2.0). After implant therapy, the oral wellbeing was significantly better than at baseline, and patient satisfaction was greater when the implants were loaded immediately (8.7 ± 1.1) than if the prosthetic rehabilitation was delayed (8.3 ± 1.1). In the GSIL group, the effect size of the OIDP exceeded the threshold value of 0.8 for all of the OIDP domains and for the total OIDP score and patient satisfaction.Conclusions A global improvement in the OHQoL scores and patient satisfaction was observed after implant therapy, but the change was marked greater in the GSIL group.",2020,"After implant therapy, the oral wellbeing was significantly better than at baseline, and patient satisfaction was greater when the implants were loaded immediately (8.7 ± 1.1) than if the prosthetic rehabilitation was delayed (8.3 ± 1.1).","['A total of 104 patients were recruited: CGCL (n = 40), GSCL (n = 35) and GSIL (n = 29', 'Case selection Patients requiring dental implants were recruited from a private dental surgery in Spain']","['conventional treatment (CGCL), in which implants were inserted after flap elevation without guiding templates; the guided surgery/conventional loading group (GSCL); and the guided surgery/immediate loading group (GSIL).Data analysis An oral examination and a questionnaire-based interview', 'implant rehabilitation']","['oral wellbeing', 'OHQoL', 'patient satisfaction', 'oral health-related quality of life', 'Daily Performances (OIDP) and Oral Satisfaction Scale (OSS', 'changes in oral health-related quality of life (OHQoL', 'total OIDP score and patient satisfaction', 'OHQoL scores and patient satisfaction']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0204324', 'cui_str': 'Dental surgical procedure'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0376306', 'cui_str': 'Oral examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",104.0,0.0812754,"After implant therapy, the oral wellbeing was significantly better than at baseline, and patient satisfaction was greater when the implants were loaded immediately (8.7 ± 1.1) than if the prosthetic rehabilitation was delayed (8.3 ± 1.1).","[{'ForeName': 'C Albert', 'Initials': 'CA', 'LastName': 'Yeung', 'Affiliation': 'Consultant in Dental Public Health, NHS Lanarkshire, Kirklands, Bothwell, G71 8BB, UK. albert.yeung@lanarkshire.scot.nhs.uk.'}]",Evidence-based dentistry,['10.1038/s41432-020-0112-8']
3092,32978539,Does personalised text messaging influence patients' caries risk?,"Design A single-blinded, randomised controlled trial. The experimental group received 24 personalised text messages each week, disseminating tailored preventive advice using the multifactorial model for individual caries risk assessment: Cariogram. The same frequency of text messaging was delivered to the control group; however, these were non-personalised messages and did not factor the Cariogram.Sample selection One hundred and ninety-one participants were assessed for eligibility by eight calibrated, volunteer dental practitioners in County Cork, Ireland. Six different inclusion criteria were detailed, including the requirement for medical card holders, serving as an indicator for economically underprivileged status. Other criteria included: aged between 19-70 years; competent with text messaging services; have a minimum of 20 teeth present; not pregnant; and prepared to give consent. Failure to return a baseline food diary or possess a mobile phone saw the exclusion of 20 participants. Following stratified and blocked randomisation, 85 and 86 participants were allocated in the test and control group, respectively. The study received ethical approval by the Clinical Research Ethics Committee of the Cork Teaching Hospitals.Data analysis One hundred and eleven participants attended the follow-up examination, 26 weeks after randomisation, where the 'chance of avoiding new cavities' was determined as a numerical index for caries risk. The secondary aim was to measure individual changes to seven Cariogram risk factors between the baseline assessment and the re-examination. The ANCOVA intention-to-threat (ITT) protocol and the per-protocol method were adhered to for analyses of outcome measures. Statistical analysis was performed using SAS 9.4, in adherence to a pre-defined significance level of 5% (two-sided).Results Both analytic techniques confirmed no statistically significant difference (p >0.05) between the groups regarding the 'chance of avoiding new cavities'. Of the risk parameters assessed, only saliva secretion demonstrated a positive effect in the intervention group (p = 0.036, OR = 0.3, 95% CI = 0.1, 0.9). Predictive modelling techniques were not reliable due to the limited sample size of per-protocol analysis.Conclusions The failure to conclude statistical significance between the groups validates the null hypothesis. Accordingly, no difference can be established between the personalised nor non-personalised mobile text messaging intervention on the caries risk of underprivileged adults in Ireland. The authors address the value of further studies exploring the potential for caries risk reduction through mobile phone communications.",2020,"Accordingly, no difference can be established between the personalised nor non-personalised mobile text messaging intervention on the caries risk of underprivileged adults in Ireland.","['Other criteria included: aged between 19-70 years; competent with', 'Sample selection One hundred and ninety-one participants were assessed for eligibility by eight calibrated, volunteer dental practitioners in County Cork, Ireland']","['text messaging services', 'personalised text messaging', '24 personalised text messages each week, disseminating tailored preventive advice using the multifactorial model for individual caries risk assessment: Cariogram']",['saliva secretion'],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0304066', 'cui_str': 'Cork'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}]","[{'cui': 'C0036104', 'cui_str': 'Salivary secretion'}]",191.0,0.122159,"Accordingly, no difference can be established between the personalised nor non-personalised mobile text messaging intervention on the caries risk of underprivileged adults in Ireland.","[{'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'School of Dentistry, Faculty of Medicine and Health, University of Leeds, Leeds, UK. dn18jyp@leeds.ac.uk.'}]",Evidence-based dentistry,['10.1038/s41432-020-0109-3']
3093,32978670,"Image Guidance for PICC Insertion: Commentary to ""Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System Versus Fluoroscopy for Placement of Peripherally Inserted Central Catheters: A Randomized, Noninferiority Comparison"".",,2020,,['PICC Insertion'],"['Magnetic Tracking and Electrocardiography-Guided Tip Confirmation System Versus Fluoroscopy', 'Inserted Central Catheters']",[],"[{'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]",[],,0.0531668,,"[{'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sone', 'Affiliation': 'National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 1040045, Japan. msone@ncc.go.jp.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02629-9']
3094,32978675,The use of retinoic acid in association with microneedling in the treatment of epidermal melasma: efficacy and oxidative stress parameters.,"This study aimed to evaluate the effectiveness of isolated treatment with retinoic acid and its combination with the microneedling technique in facial melasma, seeking to associate these results with possible oxidative damage. This is a blinded randomized clinical trial with 42 women with facial melasma (skin phototype I-IV), randomized into Group A (microneedling and 5% retinoic acid) or Group B (5% retinoic acid alone). Four procedures were applied with 15 days intervals (4 blood collections). Clinical improvement was assessed using the Melasma Area Severity Index (MASI). Serum oxidative stress levels were evaluated by protein oxidation (carbonyl), lipid peroxidation (TBARS) and sulfhydryl groups, as well as enzyme activities of superoxide dismutase (SOD) and catalase (CAT). The statistical analyzes were performed by generalized estimation equation (GEE). There was a reduction in MASI scale and TBARS levels in both groups over time (p < 0.05), with no difference between groups (p = 0.416). There was also a substantial increase in the carbonyl levels at 30 days (p = 0.002). The SOD activity decreased after 30 days, regardless of group (p < 0.001), which was maintained after 60 days. In Group A, there was a reduction in sulfhydryl levels at 60 days (p < 0.001). It is important to highlight that both groups demonstrated efficacy in the clinical improvement of melasma within at least 60 days, reducing the MASI score by almost 50%. However, microneedling with retinoic acid seems to be the worst treatment because there is a reduction in the non-enzymatic antioxidant defense, which is important to protect against oxidative stress.",2020,"There was a reduction in MASI scale and TBARS levels in both groups over time (p < 0.05), with no difference between groups (p = 0.416).","['epidermal melasma', '42 women with facial melasma (skin phototype I-IV']","['Group A (microneedling and 5% retinoic acid) or Group B (5% retinoic acid alone', 'retinoic acid', 'retinoic acid and its combination with the microneedling technique']","['carbonyl levels', 'MASI scale and TBARS levels', 'protein oxidation (carbonyl), lipid peroxidation (TBARS) and sulfhydryl groups, as well as enzyme activities of superoxide dismutase (SOD) and catalase (CAT', 'Melasma Area Severity Index (MASI', 'SOD activity', 'Serum oxidative stress levels', 'sulfhydryl levels', 'MASI score']","[{'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",42.0,0.0439211,"There was a reduction in MASI scale and TBARS levels in both groups over time (p < 0.05), with no difference between groups (p = 0.416).","[{'ForeName': 'Clarissa L M da Silva', 'Initials': 'CLMDS', 'LastName': 'Bergmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação, Centro Universitário Metodista - IPA, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação, Centro Universitário Metodista - IPA, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Bergmann', 'Affiliation': 'Médico Cirurgião Geral Pela Universidade Federal do Rio Grande do Sul-Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Fernanda Brasil', 'Initials': 'FB', 'LastName': 'Bocca', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação, Centro Universitário Metodista - IPA, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Proença', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação, Centro Universitário Metodista - IPA, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Marinho', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação, Centro Universitário Metodista - IPA, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mello', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação, Centro Universitário Metodista - IPA, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação, Centro Universitário Metodista - IPA, Porto Alegre, RS, Brazil. carolinedani@yahoo.com.br.'}]",Archives of dermatological research,['10.1007/s00403-020-02140-8']
3095,32978722,A Phase I Placebo-Controlled Trial Comparing the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration on Respiratory Drive.,"INTRODUCTION


Buprenorphine is a partial μ-opioid receptor agonist that, unlike full μ-opioid receptor agonists, has been shown to have a ceiling effect on respiratory depression. Buprenorphine buccal film (BBF) is approved by the US Food and Drug Administration for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate. This study was conducted to compare the effects of BBF and immediate-release oral oxycodone hydrochloride administration on respiratory drive, as measured by the ventilatory response to hypercapnia (VRH) after drug administration.
METHODS


Subjects (N = 19) were men and women, ages 27-41 years, self-identifying as recreational opioid users who were not physically dependent on opioids as determined via a Naloxone Challenge Test. Respiratory drive was evaluated by measuring VRH through the assessment of the maximum decrease in minute ventilation (E max ) after administration of each treatment. The treatments utilized in this study included 300, 600, and 900 μg BBF; 30 and 60 mg orally administered oxycodone; and placebo (each separated by a 7-day washout period). Effects on respiratory drive were assessed using a double-blind, double-dummy, six-treatment, six-period, placebo-controlled, randomized crossover design. Statistical analyses were performed using a linear mixed-effects model.
RESULTS


The least squares mean differences in minute volume E max  (L/min, versus placebo) were as follows: 300 μg BBF (+ 1.24, P = 0.529), 600 μg BBF (+ 0.23, P = 0.908), 900 μg BBF (+ 0.93, P = 0.637), 30 mg oxycodone (- 0.79, P = 0.687), and 60 mg oxycodone (- 5.23, P = 0.010).
CONCLUSIONS


BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg. Administration of oxycodone resulted in a significant dose-dependent decrease in respiratory drive. These data suggest that BBF may be a safer treatment option than full μ-opioid receptor agonists for patients with chronic pain.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03996694.",2020,"CONCLUSIONS


BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg.","['300, 600, and 900\xa0μg BBF; 30 and 60\xa0mg orally administered', 'patients with chronic pain severe', 'Subjects (N\u2009=\u200919) were men and women, ages 27-41\xa0years, self-identifying as recreational opioid users who were not physically dependent on opioids as determined via a Naloxone Challenge Test', 'patients with chronic pain']","['Buprenorphine buccal film (BBF', 'oxycodone; and placebo', 'Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride', 'Buprenorphine', 'BBF', 'oxycodone hydrochloride', 'placebo', 'oxycodone', 'Placebo']","['minute ventilation (E max ', 'ventilatory response to hypercapnia (VRH', 'respiratory drive']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C4056633', 'cui_str': 'Buprenorphine Buccal Film [Belbuca]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C4056633', 'cui_str': 'Buprenorphine Buccal Film [Belbuca]'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]",,0.319049,"CONCLUSIONS


BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg.","[{'ForeName': 'Lynn R', 'Initials': 'LR', 'LastName': 'Webster', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA. WebsterLynn@prahs.com.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hansen', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Cater', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'BioDelivery Sciences International, Inc., Raleigh, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01481-0']
3096,32978836,A novel virtual reality-based Theory of Mind intervention for outpatients with schizophrenia: a proof of concept pilot study.,"Schizophrenia is a severe and highly disabling mental illness. While several pharmacological solutions are available to alleviate symptoms of schizophrenia, they do not seem to provide solution for accompanying social dysfunctions. To handle this unmet clinical need, many innovative interventions have been developed recently. Considering the promising results on this field and the development trend, characterized by the growing proportion of included interactive technology, our research team developed a novel virtual reality (VR) based targeted Theory of Mind (ToM) intervention (VR-ToMIS) for stable outpatients with schizophrenia. VR-ToMIS is a 9-session long structured and individualized method that uses cognitive and behavioral therapeutic techniques in an immersive VR environment. Our study was a randomized, controlled pilot study. Twenty-one patients have been recruited and randomly allocated to either VR-ToMIS or passive-VR condition. Patients assigned to passive VR condition could use the same VR software as the VR-ToMIS group, but without any interventions. Effects on psychiatric symptoms, neurocognitive- and social cognitive functions, pragmatic language skills and quality of life were evaluated by using analysis of covariance. According to our results, VR-ToMIS was associated with improvements in negative symptoms, in one neurocognitive field (immediate memory), Theory of Mind and pragmatic language skills, but no significant change in Quality of Life scores was detected. Significant changes in VR-ToMIS group were associated with moderate to large therapeutic effects (η p   2  = .24 - .46, φ=.55 - .67). On the background of the presented pilot results VR-ToMIS is concluded to be feasible and tolerable.",2020,"Significant changes in VR-ToMIS group were associated with moderate to large therapeutic effects (η p   2  = .24 - .46, φ=.55 - .67).","['stable outpatients with schizophrenia', 'outpatients with schizophrenia']","['novel virtual reality (VR) based targeted Theory of Mind (ToM) intervention (VR-ToMIS', 'novel virtual reality-based Theory of Mind intervention', 'VR-ToMIS or passive-VR condition']","['Quality of Life scores', 'negative symptoms, in one neurocognitive field (immediate memory), Theory of Mind and pragmatic language skills', 'psychiatric symptoms, neurocognitive- and social cognitive functions, pragmatic language skills and quality of life']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",21.0,0.0147767,"Significant changes in VR-ToMIS group were associated with moderate to large therapeutic effects (η p   2  = .24 - .46, φ=.55 - .67).","[{'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Vass', 'Affiliation': 'Semmelweis University, Faculty of Medicine, Department of Psychiatry and Psychotherapy, Budapest, Hungary.'}, {'ForeName': 'Viktória', 'Initials': 'V', 'LastName': 'Simon', 'Affiliation': 'Semmelweis University, Faculty of Medicine, Department of Psychiatry and Psychotherapy, Budapest, Hungary.'}, {'ForeName': 'Zita', 'Initials': 'Z', 'LastName': 'Fekete', 'Affiliation': 'University of Debrecen, Institute of Behavioral Sciences, Hungary.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lencse', 'Affiliation': 'Semmelweis University, Faculty of Medicine, Hungary.'}, {'ForeName': 'Mária', 'Initials': 'M', 'LastName': 'Ecseri', 'Affiliation': 'Semmelweis University, Faculty of Medicine, Hungary.'}, {'ForeName': 'Balázs', 'Initials': 'B', 'LastName': 'Kis', 'Affiliation': 'Szalbolcs-Szatmar-Bereg County Hospital and University Teaching Hospital, Department of Psychiatry, Hungary.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Simon', 'Affiliation': 'Semmelweis University, Faculty of Medicine, Department of Psychiatry and Psychotherapy, Budapest, Hungary.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2519']
3097,32978842,Comparing the Use of a Novel Antibiotic-free Film-Forming Topical Wound Dressing versus a Topical Triple Antibiotic in Dermatologic Surgical Procedures including Mohs Micrographic Surgery.,"BACKGROUND


There is no universally accepted protocol of topical wound care after cutaneous surgical procedures. The current practice is to use petrolatum-based products, commonly containing topical antibiotics. The rise in antibiotic-resistant bacteria and increased risk of allergic and contact dermatitis due to the use of topical antibiotics is well established.
OBJECTIVE


To compare the prevalence of contact dermatitis, the infection rate, and the subjective measures of healing of a novel, antibiotic-free, film-forming silicone-based wound dressing to a topical triple antibiotic petrolatum-based ointment in patients undergoing invasive dermatological interventions in two arms: (1) Mohs Micrographic Surgery (MMS) and (2) a combination of various routine dermatologic surgical procedures .
DESIGN


231 patients were enrolled in this open label, randomized, single blinded study. Patients applied the products immediately after surgery and daily afterwards. Clinicians evaluated the surgical site for infection or contact dermatitis at all follow-up visits. Acute wound healing progression was assessed using a rating scale against clinical experience and expected results from -4 (much worse) to +4 (much better).
RESULTS


Contact dermatitis was significantly decreased in the wound dressing group compared to the topical antibiotic group (0 vs 15.9%, p<0.001). There was no difference between the study arms (Mohs vs. Non- Mohs, p=0.242). Infection rate was not significantly different between the groups (p>0.05) and between the study arms (p>0.05). Assessor rated secondary outcomes like healing time, healing quality, erythema and new tissue quality were significantly better in the wound dressing group while comfort and perceived overall satisfaction were better in the antibiotic group. Patient rated outcomes did not show any difference between groups and between study arms.
CONCLUSION


The wound dressing used in this study is a topical silicone gel preparation and presents a viable alternative to topical antibiotics for post-operative wound care without enhancing the risk of infection.",2020,"There was no difference between the study arms (Mohs vs. Non- Mohs, p=0.242).","['patients undergoing invasive dermatological interventions in two arms: (1) Mohs', '231 patients', 'Dermatologic Surgical Procedures including Mohs Micrographic Surgery']","['silicone-based wound dressing to a topical triple antibiotic petrolatum-based ointment', 'Micrographic Surgery (MMS) and (2) a combination of various routine dermatologic surgical procedures ', 'topical antibiotic', 'Novel Antibiotic-free Film-Forming Topical Wound Dressing versus a Topical Triple Antibiotic']","['Acute wound healing progression', 'Infection rate', 'surgical site for infection or contact dermatitis', 'comfort and perceived overall satisfaction', 'healing time, healing quality, erythema and new tissue quality', 'Contact dermatitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1555645', 'cui_str': 'Mohawk language'}, {'cui': 'C3266910', 'cui_str': 'Cutaneous Surgical Procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079850', 'cui_str': 'Mohs surgery'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0178388', 'cui_str': 'Dressing of wound'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}, {'cui': 'C0028911', 'cui_str': 'Ointment Bases'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0079850', 'cui_str': 'Mohs surgery'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3266910', 'cui_str': 'Cutaneous Surgical Procedures'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0011616', 'cui_str': 'Contact dermatitis'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",231.0,0.0541672,"There was no difference between the study arms (Mohs vs. Non- Mohs, p=0.242).","[{'ForeName': 'Anthony V', 'Initials': 'AV', 'LastName': 'Benedetto', 'Affiliation': 'Clinical Professor of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Staidle', 'Affiliation': 'Skin Cancer & Dermatology Institute, 640 West Moana Lane, Reno, NV, 89509, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Schoenfeld', 'Affiliation': 'Pennsylvania Dermatology Partners, Roosevelt Boulevard Suite 508, Philadelphia, PA, USA.'}, {'ForeName': 'Ernest A', 'Initials': 'EA', 'LastName': 'Benedetto', 'Affiliation': 'Dermatologic SurgiCenter, 1200 Locust Street, Philadelphia, PA, 19107, USA.'}, {'ForeName': 'Paul X', 'Initials': 'PX', 'LastName': 'Benedetto', 'Affiliation': 'Dermatologic SurgiCenter, 1200 Locust Street, Philadelphia, PA, 19107, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16965']
3098,32978908,Potency and use of chia mucilage coating containing propolis liquid extract for improves shelf-life of sea bass fillets.,"BACKGROUND


In this study the effects of the use of chia mucilage - CM coating in combination with propolis liquid extract - PLE on the physico-chemical (total volatile basic nitrogen - TVB-N, peroxide value - PV, thiobarbituric acid - TBA) and bacteriological (total viable count - TVC, psychrophilic bacteria count -PBC) quality properties of sea bass fillets during storage at 2°C, as well as its potency, were investigated.
METHODS


The fillets were randomly separated into four lots and subjected to the following treatments by dipping: chia mucilage - CM, chia mucilage + 0.1% PLE, chia mucilage + 0.3% PLE and control (uncoated), then stored at 2°C.
RESULTS


The results showed that the chia musilage coating containing PLE was effective on TVC and PCA. While the shelf life of the control group was 8 days, the CM + 0.3% PLE group was 20 days.
CONCLUSIONS


According to these results, it can be said that chia mucilage coating preserves the shelf life and quality of chilled seafood and can be used safely as a coating material.",2020,"While the shelf life of the control group was 8 days, the CM + 0.3% PLE group was 20 days.
",[],"['dipping: chia mucilage - CM, chia mucilage + 0.1% PLE, chia mucilage + 0.3% PLE and control (uncoated', 'chia mucilage coating containing propolis liquid extract', 'PLE']","['physico-chemical (total volatile basic nitrogen - TVB-N, peroxide value - PV, thiobarbituric acid - TBA) and bacteriological (total viable count - TVC, psychrophilic bacteria count -PBC) quality properties', 'shelf-life of sea bass fillets', 'TVC and PCA']",[],"[{'cui': 'C0037390', 'cui_str': 'Snuff tobacco'}, {'cui': 'C3256719', 'cui_str': 'Salvia hispanica seed extract'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0449200', 'cui_str': 'PLE'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C1720014', 'cui_str': 'Liquid extract'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0031180', 'cui_str': 'Peroxide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0076442', 'cui_str': 'thiobarbituric acid'}, {'cui': 'C0205465', 'cui_str': 'Bacteriologic'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0453011', 'cui_str': 'Sea bass'}, {'cui': 'C0184934', 'cui_str': 'Filleting'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}]",,0.0176506,"While the shelf life of the control group was 8 days, the CM + 0.3% PLE group was 20 days.
","[{'ForeName': 'Mehmet Zülfü', 'Initials': 'MZ', 'LastName': 'Coban', 'Affiliation': 'Keban Vocational Schools, Fırat University, Keban, Turkey.'}, {'ForeName': 'Ozlem Emir', 'Initials': 'OE', 'LastName': 'Coban', 'Affiliation': 'Department of Fish Processing Technology, Fırat University, Elazig, Turkey.'}]",Acta scientiarum polonorum. Technologia alimentaria,['10.17306/J.AFS.0843']
3099,32978984,"The effects of text messaging for promoting the retention of the first-time blood donors, a randomized controlled study (TEXT study).","BACKGROUND


Donor recruiting remains a challenging process to obtain sufficient blood product supply worldwide. This was a randomized controlled trial aimed to evaluate the efficacy of text messaging for promoting the retention of first-time blood donors.
STUDY DESIGN AND METHODS


Participants enrolled were 18 years of age or older who were first-time blood donors and able to understand text messages. Participants were randomized in a 1:1 ratio (text group vs control group). Only participants who were allocated in the ""text group"" received a text message once their blood product was dispatched from the transfusion service. The content of the text message was ""We would like to inform you that your blood has been used for patients on the date (DD/MM/YY)."" The primary outcome of the study was the rate of returning at 9 months after the first donation.
RESULTS


In an intention-to-treat analysis, 1270 participants were allocated to the text group and 1270 participants to the control group. The primary outcome occurred in 199 in the text group (22.4 per 100 donor-years) and 152 in the control group (16.9 per 100 donor-years). The incidence rate ratio was 1.31 (95% confidence interval, 1.06-1.63; P = .005). The number needed to treat was 22. The median time to return for blood donation was 112 days (interquartile range [IQR], 98-146) in the text group and 113 days (IQR, 97-144) in the control group.
CONCLUSION


Among first-time blood donors, text messaging after blood product being dispatched is an effective and simple intervention to increase the retention rate for subsequent donations.",2020,"The incidence rate ratio was 1.31 (95% confidence interval, 1.06-1.63; P = .005).","['1270 participants were allocated to the text group and 1270 participants to the control group', 'Participants enrolled were 18\u2009years of age or older who were first-time blood donors and able to understand text messages']",['text messaging'],"['median time to return for blood donation', 'rate of returning at 9 months after the first donation', 'incidence rate ratio', 'retention rate']","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",1270.0,0.119396,"The incidence rate ratio was 1.31 (95% confidence interval, 1.06-1.63; P = .005).","[{'ForeName': 'Chontara', 'Initials': 'C', 'LastName': 'Pongsananurak', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Lalita', 'Initials': 'L', 'LastName': 'Norasetthada', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Adisak', 'Initials': 'A', 'LastName': 'Tantiworawit', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Ekarat', 'Initials': 'E', 'LastName': 'Rattarittamrong', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Thanawat', 'Initials': 'T', 'LastName': 'Rattanathammethee', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sasinee', 'Initials': 'S', 'LastName': 'Hantrakool', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Pokpong', 'Initials': 'P', 'LastName': 'Piriyakhuntorn', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Maitree', 'Initials': 'M', 'LastName': 'Sriwichai', 'Affiliation': 'Blood Bank Section, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Nipapan', 'Initials': 'N', 'LastName': 'Leetrakool', 'Affiliation': 'Blood Bank Section, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Chatree', 'Initials': 'C', 'LastName': 'Chai-Adisaksopha', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}]",Transfusion,['10.1111/trf.15984']
3100,32979027,Like clouds in a windy sky: Mindfulness training reduces negative affect reactivity in daily life in a randomized controlled trial.,"While prior research has found mindfulness to be linked with emotional responses to events, less is known about this effect in a non-clinical sample. Even less is known regarding the mechanisms of the underlying processes: It is unclear whether participants who exhibit increased acceptance show decreased emotional reactivity (i.e., lower affective responses towards events overall) or a speedier emotional recovery (i.e., subsequent decrease in negative affect) due to adopting an accepting stance. To address these questions, we re-analyzed two Ambulatory Assessment data sets. The first (N Study1  = 125) was a six-week randomized controlled trial (including a 40-day ambulatory assessment); the second (N Study2  = 175) was a one-week ambulatory assessment study. We found state mindfulness to be more strongly associated with emotional reactivity than with recovery, and that only emotional reactivity was significantly dampened by mindfulness training. Regarding the different facets of mindfulness, we found that the strongest predictor of both emotional reactivity and recovery was non-judgmental acceptance. Finally, we found that being aware of one's own thoughts and behavior could be beneficial or detrimental for emotional recovery, depending on whether participants accepted their thoughts and emotions. Together, these findings provide evidence for predictions derived from the monitoring and acceptance theory. This article is protected by copyright. All rights reserved.",2020,"We found state mindfulness to be more strongly associated with emotional reactivity than with recovery, and that only emotional reactivity was significantly dampened by mindfulness training.",[],['40-day ambulatory assessment'],['emotional reactivity'],[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0324028,"We found state mindfulness to be more strongly associated with emotional reactivity than with recovery, and that only emotional reactivity was significantly dampened by mindfulness training.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Wenzel', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Zarah', 'Initials': 'Z', 'LastName': 'Rowland', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kubiak', 'Affiliation': 'Institute of Psychology, Johannes Gutenberg University, Mainz, Germany.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2989']
3101,32979042,Quality of life outcomes from a randomized controlled trial of patient navigation in Latina breast cancer survivors.,"INTRODUCTION


Breast cancer survivorship is a life-long process involving challenges to health-care communities and individuals, especially Latinas. Patient Navigation has shown some success in meeting these challenges. The purpose of this study was to compare the effects of an enhanced Patient Navigation program (Intervention; PN+) vs Control (PN) over time on general cancer and breast cancer-specific quality of life (QoL) in Latina breast cancer survivors (BCS).
METHODS


We conducted a 2-year, two-arm randomized controlled trial of the ""Staying Healthy"" program among Latina BCS. The design compared PN+ vs PN over time. We recruited 60 patients into each study arm and randomized them by sequential numerical assignment. PN+ participants received culturally tailored educational materials and active, personalized Patient Navigation services, including phone calls, transportation, and care coordination. PN participants were navigated only upon request. Primary outcomes included general cancer (Functional Assessments of Cancer Therapy [FACTS]-G) and breast cancer-specific (FACT-B) QoL.
RESULTS


PN+ participants had significantly improved QoL measures compared to PN at 6-month follow-up on all subscales (P-values .007-.04) except physical well-being (PWB; P = .11). Intervention effect size coefficient (standard error) for FACT-G overall was 7.9 (3.1); P = .01. For FACT-B, it was 10.9 (3.9); P = .006. Again, all subscales showed significant effects [range 1.7-3.1 (0.8-1.2); P-values .006-.04], except for PWB [1.5 (1.0); P = .16] and social/family well-being (SWB) [2.1 (1.1); P = .06]. There were no differences between groups at baseline.
DISCUSSION


Multiple cultural, psychosocial, and socioeconomic variables contributing to these intervention effects will be addressed in future studies. As the national BCS population continues to increase, more Patient Navigation-focused partnerships among patients, health-care professionals, research groups, and community organizations are needed to improve BCS experiences. The Staying Healthy program has the potential to serve as a national survivorship care model for improving Latina BCS QoL.",2020,"QoL.
RESULTS


PN+ participants had significantly improved QoL measures compared to PN at 6-month follow-up on all subscales (P-values .007-.04) except physical well-being (PWB; P = .11).","['Latina breast cancer survivors (BCS', 'Latina breast cancer survivors', 'Latina BCS']","['Staying Healthy"" program', 'patient navigation', 'enhanced Patient Navigation program (Intervention; PN+) vs Control (PN', 'culturally tailored educational materials and active, personalized Patient Navigation services, including phone calls, transportation, and care coordination']","['Quality of life outcomes', 'general cancer and breast cancer-specific quality of life (QoL', 'QoL measures', 'general cancer (Functional Assessments of Cancer Therapy [FACTS]-G) and breast cancer-specific (FACT-B']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",60.0,0.0566853,"QoL.
RESULTS


PN+ participants had significantly improved QoL measures compared to PN at 6-month follow-up on all subscales (P-values .007-.04) except physical well-being (PWB; P = .11).","[{'ForeName': 'Amelie G', 'Initials': 'AG', 'LastName': 'Ramirez', 'Affiliation': 'Department of Population Health Sciences, UT Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Muñoz', 'Affiliation': 'Department of Population Health Sciences, UT Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Long Parma', 'Affiliation': 'Department of Population Health Sciences, UT Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Arely', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Department of Population Health Sciences, UT Health San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Santillan', 'Affiliation': 'Department of Population Health Sciences, UT Health San Antonio, San Antonio, TX, USA.'}]",Cancer medicine,['10.1002/cam4.3272']
3102,32979066,"Early clinical effects, safety, and appropriate selection of bone markers in romosozumab treatment for osteoporosis patients: a 6-month study.","Our 6-month study showed the usefulness of romosozumab for preventing fractures and its safety. It was effective in patients with low baseline spine BMD, high TRACP-5b, and high iP1NP. Percent change from baseline of TRACP-5b and iP1NP after 1 month correlated with that from baseline of BMD after four to 6-month treatment.
INTRODUCTION


Romosozumab appeared as a new osteoporosis medication in Japan in 2019. It is an anti-sclerostin antibody which increases bone formation and suppresses bone resorption. In this study, we analyzed the actual clinical effects, adverse effects, and the optimal way to evaluate the treatment.
METHODS


Romosozumab was administered as subcutaneous injection of 210 mg once every 4 weeks. We conducted pre-post study in 185 patients treated for 6 months. We focused on the incidence of new vertebral fractures, safety, bone mineral density (BMD) at the spine and total hip, and bone metabolism markers. We evaluated BMD before romosozumab treatment and after 4 to 6 months and performed the serum analysis before romosozumab treatment, after 1, 3, and 6 months.
RESULTS


There was no new fracture during treatment, and there was no fatal adverse event including cardiovascular disease. Since percent changes from baseline of the spine and total hip BMD were 6.34% and 1.53% after 4- to 6-month treatment, the treatment was effective for spine osteoporosis. Tartrate-resistant acid phosphatase 5b (TRACP-5b) and intact type I procollagen N-terminal propeptide (iP1NP) had significant changes during romosozumab treatment (p < 0.05). Percent change from baseline of TRACP-5b and iP1NP after 1 month correlated with percent change from baseline of BMD after 4 to 6 months of treatment.
CONCLUSION


Romosozumab is effective in preventing fractures and useful for increasing the spine BMD. Also, romosozumab is relatively safe to use. It is especially effective in patients with low baseline spine BMD, high TRACP-5b, and high iP1NP.",2020,I procollagen N-terminal propeptide (iP1NP) had significant changes during romosozumab treatment (p < 0.05).,"['185 patients treated for 6\xa0months', 'patients with low baseline spine BMD, high TRACP-5b, and high iP1NP', 'osteoporosis patients']","['Tartrate-resistant acid phosphatase 5b (TRACP-5b) and intact type', 'Romosozumab', 'romosozumab']","['TRACP-5b and iP1NP', 'spine and total hip BMD', 'fatal adverse event including cardiovascular disease', 'new vertebral fractures, safety, bone mineral density (BMD) at the spine and total hip, and bone metabolism markers', 'BMD', 'bone formation and suppresses bone resorption']","[{'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}]","[{'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}]",185.0,0.0228051,I procollagen N-terminal propeptide (iP1NP) had significant changes during romosozumab treatment (p < 0.05).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tominaga', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan. keijiwadajp@yahoo.co.jp.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Kita Shinagawa 3rd Hospital, Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nishi', 'Affiliation': 'Hasuda Hospital, Saitama, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Terayama', 'Affiliation': 'Hasuda Hospital, Saitama, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Okazaki', 'Affiliation': ""Department of Orthopedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.""}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05639-y']
3103,32979074,"The interaction between metformin and physical activity on postprandial glucose and glucose kinetics: a randomised, clinical trial.","AIMS/HYPOTHESIS


The aim of this parallel-group, double-blinded (study personnel and participants), randomised clinical trial was to assess the interaction between metformin and exercise training on postprandial glucose in glucose-intolerant individuals.
METHODS


Glucose-intolerant (2 h OGTT glucose of 7.8-11.0 mmol/l and/or HbA 1c  of 39-47 mmol/mol [5.7-6.5%] or glucose-lowering-medication naive type 2 diabetes), overweight/obese (BMI 25-42 kg/m 2 ) individuals were randomly allocated to a placebo study group (PLA, n = 15) or a metformin study group (MET, n = 14), and underwent 3 experimental days: BASELINE (before randomisation), MEDICATION (after 3 weeks of metformin [2 g/day] or placebo treatment) and TRAINING (after 12 weeks of exercise training in combination with metformin/placebo treatment). Training consisted of supervised bicycle interval sessions with a mean intensity of 64% of Watt max  for 45 min, 4 times/week. The primary outcome was postprandial glucose (mean glucose concentration) during a mixed meal tolerance test (MMTT), which was assessed on each experimental day. For within-group differences, a group × time interaction was assessed using two-way repeated measures ANOVA. Between-group changes of the outcomes at different timepoints were compared using unpaired two-tailed Student's t tests.
RESULTS


Postprandial glucose improved from BASELINE to TRAINING in both the PLA group and the MET group (∆PLA: -0.7 [95% CI -1.4, 0.0] mmol/l, p = 0.05 and ∆MET: -0.7 [-1.5, -0.0] mmol/l, p = 0.03), with no between-group difference (p = 0.92). In PLA, the entire reduction was seen from MEDICATION to TRAINING (-0.8 [-1.3, -0.1] mmol/l, p = 0.01). Conversely, in MET, the entire reduction was observed from BASELINE to MEDICATION (-0.9 [-1.6, -0.2] mmol/l, p = 0.01). The reductions in mean glucose concentration during the MMTT from BASELINE to TRAINING were dependent on differential time effects: in the PLA group, a decrease was observed at timepoint (t) = 120 min (p = 0.009), whereas in the MET group, a reduction occurred at t = 30 min (p < 0.001). V̇O 2peak  increased 15% (4.6 [3.3, 5.9] ml kg -1  min -1 , p < 0.0001) from MEDICATION to TRAINING and body weight decreased (-4.0 [-5.2, -2.7] kg, p < 0.0001) from BASELINE to TRAINING, with no between-group differences (p = 0.7 and p = 0.5, respectively).
CONCLUSIONS/INTERPRETATION


Metformin plus exercise training was not superior to exercise training alone in improving postprandial glucose. The differential time effects during the MMTT suggest an interaction between the two modalities.
FUNDING


The Beckett foundation, A.P Møller Foundation, DDA, the Research Foundation of Rigshospitalet and Trygfonden.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03316690). Graphical abstract.",2020,"V̇O 2peak  increased 15% (4.6 [3.3, 5.9] ml","['glucose-intolerant individuals', 'Glucose-intolerant', 'and/or HbA 1c  of 39-47\xa0mmol/mol [5.7-6.5%] or glucose-lowering-medication naive type 2 diabetes), overweight/obese (BMI 25-42\xa0kg/m 2 ) individuals']","['supervised bicycle interval sessions', 'metformin and exercise training', 'Metformin plus exercise training', 'metformin', '∆MET', 'placebo', 'exercise training in combination with metformin/placebo', 'metformin and physical activity', 'metformin [2 g/day] or placebo']","['mean glucose concentration', 'postprandial glucose (mean glucose concentration) during a mixed meal tolerance test (MMTT', 'Postprandial glucose', 'body weight', 'V̇O 2peak', 'postprandial glucose', 'postprandial glucose and glucose kinetics']","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",,0.0715899,"V̇O 2peak  increased 15% (4.6 [3.3, 5.9] ml","[{'ForeName': 'Nanna S', 'Initials': 'NS', 'LastName': 'Pilmark', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lyngbæk', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Oberholzer', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Elkjær', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Petersen-Bønding', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Kofoed', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Siebenmann', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Kellenberger', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Biomedical Sciences, Faculty of Health & Medical Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Abildgaard', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Lauridsen', 'Affiliation': 'Department of Diagnostic Radiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Katrine B', 'Initials': 'KB', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'Centre for Physical Activity Research (CFAS), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. Kristian.karstoft@regionh.dk.'}]",Diabetologia,['10.1007/s00125-020-05282-6']
3104,32979077,"No effect of 6-month supplementation with 300 mg/d docosahexaenoic acid on executive functions among healthy school-aged children: a randomized, double-blind, placebo-controlled trial.","PURPOSE


Docosahexaenoic acid (DHA) plays an essential role in brain, and its status is dependent on dietary intakes. School-aged children in rural China, who consume diets low in omega-3 polyunsaturated fatty acids, may benefit from DHA supplementation. Therefore, this trial was performed to examine the effect of 6-month DHA supplementation on executive functions (EFs) among healthy school-aged children in rural China.
METHODS


A randomized, double-blind, placebo-controlled trial was conducted among 106 primary school children aged 7-12 years in rural China. Participants were randomized to receive either 300 mg/d DHA or placebo for 6 months. EFs including working memory and cognitive flexibility were evaluated at baseline, at 3 months and at 6 months, using Digit Span Backwards and Wisconsin card sorting test, respectively. Socio-demographic data were collected at baseline, and erythrocyte membrane fatty acids and serum neurotransmitters were measured at baseline and after 6-month intervention.
RESULTS


Ninety-four children (88.7%) completed the study according to the protocol. Changes in erythrocyte membrane fatty acids indicated good compliance of the participants. There was no significant intervention effect on serum neurotransmitters. In two-factor ANCOVA, both groups showed a significant improvement in the Digit Span Backwards and the Wisconsin card sorting test from baseline to endpoint. However, no significant intervention effect was found on any EF scores. Linear regression analysis suggested no significant association between changes in erythrocyte DHA level with changes in any EF scores.
CONCLUSIONS


Supplementation with 300 mg/d DHA for 6 months had no benefit on EFs including working memory and cognitive flexibility among healthy school-aged children. This trial was registered at clinicaltrials.gov as NCT02308930 on December 5, 2014.",2020,"In two-factor ANCOVA, both groups showed a significant improvement in the Digit Span","['Ninety-four children (88.7%) completed the study according to the protocol', 'healthy school-aged children', 'School-aged children in rural China', 'healthy school-aged children in rural China', '106 primary school children aged 7-12\xa0years in rural China']","['300\xa0mg/d DHA or placebo', 'DHA supplementation', 'Docosahexaenoic acid (DHA', '6-month supplementation with 300\xa0mg/d docosahexaenoic acid', 'placebo', 'omega-3 polyunsaturated fatty acids']","['EF scores', 'executive functions (EFs', 'EFs including working memory and cognitive flexibility', 'serum neurotransmitters', 'Socio-demographic data', 'erythrocyte membrane fatty acids and serum neurotransmitters', 'erythrocyte DHA level', 'Digit Span', 'executive functions', 'working memory and cognitive flexibility']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0014780', 'cui_str': 'Erythrocyte Cytoskeleton'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}]",94.0,0.493506,"In two-factor ANCOVA, both groups showed a significant improvement in the Digit Span","[{'ForeName': 'Guo-Yi', 'Initials': 'GY', 'LastName': 'Yang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th Zhongshan Er Road, Guangzhou, 510080, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th Zhongshan Er Road, Guangzhou, 510080, China.'}, {'ForeName': 'Si-Yu', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th Zhongshan Er Road, Guangzhou, 510080, China.'}, {'ForeName': 'Bi-Xia', 'Initials': 'BX', 'LastName': 'Huang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th Zhongshan Er Road, Guangzhou, 510080, China.'}, {'ForeName': 'Hai-Lin', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th Zhongshan Er Road, Guangzhou, 510080, China.'}, {'ForeName': 'Qiu-Ye', 'Initials': 'QY', 'LastName': 'Lan', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th Zhongshan Er Road, Guangzhou, 510080, China.'}, {'ForeName': 'Chun-Lei', 'Initials': 'CL', 'LastName': 'Li', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th Zhongshan Er Road, Guangzhou, 510080, China.'}, {'ForeName': 'Hui-Lian', 'Initials': 'HL', 'LastName': 'Zhu', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th Zhongshan Er Road, Guangzhou, 510080, China. zhuhl@mail.sysu.edu.cn.'}, {'ForeName': 'Ai-Ping', 'Initials': 'AP', 'LastName': 'Fang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University, 74th Zhongshan Er Road, Guangzhou, 510080, China. fangaip@mail.sysu.edu.cn.'}]",European journal of nutrition,['10.1007/s00394-020-02388-w']
3105,32979134,A pilot feasibility randomized controlled trial adding behavioral counseling to supervised physical activity in prostate cancer survivors: behavior change in prostate cancer survivors trial (BOOST).,"The purpose of this study was to evaluate the feasibility of delivering a supervised physical activity program plus standard exercise counseling (PA + EC) versus a supervised physical activity plus motivationally-enhanced behavioral counseling (PA + BC) in prostate cancer survivors. Secondary outcomes included objectively assessed PA, quality of life, body composition, cardiorespiratory fitness, cognitive functioning, and physical function. Twenty-six prostate cancer survivors were randomized to a 12-week supervised PA program plus standard exercise counseling or a 12-week supervised PA plus behavioral counseling based on the Multi-Process Action Control framework. Feasibility was determined through enrolment rate, measurement completion rate, loss-to-follow-up, adherence to the intervention, adverse events, and program evaluation items assessing burden and satisfaction. Of the 26 prostate cancer survivors enrolled (M age  = 65.6 ± 6.8), 96% completed the intervention. Measurement completion rates for the study measures were 88.5%. Adherence to the supervised PA sessions was 92% (completed 11/12 supervised PA sessions) and 100% (completed 12/12 supervised PA sessions) in the PA + EC and PA + BC group, respectively. Adherence to the home-based PA sessions was 70% (completed 7/10 home-based sessions) and 90% (completed 9/10 home-based sessions) in the PA + EC and PA + BC group, respectively. Overall, prostate cancer survivors were highly satisfied with the intervention components and found it rewarding, useful for research helping others, and useful for them personally. The patterns in the secondary outcomes were consistent with a positive impact of the intervention, favoring the PA + BC group. Preliminary evidence suggests that adding behavioral counseling to supervised PA in prostate cancer survivors may be feasible and result in better adherence to PA compared to exercise counseling alone, although additional refinement is needed. A combination of supervised and home-based PA may be feasible for behavior change in the self-management of prostate cancer. The study is registered with http://ClinicalTrials.gov (ID NCT03191968).",2020,"Overall, prostate cancer survivors were highly satisfied with the intervention components and found it rewarding, useful for research helping others, and useful for them personally.","['26 prostate cancer survivors enrolled (M age \u2009=\u200965.6\u2009±\u20096.8), 96% completed the intervention', 'Twenty-six prostate cancer survivors', 'prostate cancer survivors']","['supervised PA program plus standard exercise counseling or a 12-week supervised PA plus behavioral counseling based on the Multi-Process Action Control framework', 'supervised physical activity program plus standard exercise counseling (PA\u2009+\u2009EC', 'supervised physical activity plus motivationally-enhanced behavioral counseling (PA\u2009+\u2009BC', 'behavioral counseling', 'supervised and home-based PA', 'behavioral counseling to supervised physical activity']","['Measurement completion rates', 'enrolment rate, measurement completion rate, loss-to-follow-up, adherence to the intervention, adverse events, and program evaluation items assessing burden and satisfaction', 'PA, quality of life, body composition, cardiorespiratory fitness, cognitive functioning, and physical function']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418878', 'cui_str': 'Recommendation to exercise'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033336', 'cui_str': 'Evaluation, Program'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",26.0,0.0764788,"Overall, prostate cancer survivors were highly satisfied with the intervention components and found it rewarding, useful for research helping others, and useful for them personally.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Trinh', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, 55 Harbord Street, Toronto, ON, M5S 2W6, Canada. linda.trinh@utoronto.ca.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychology, Northeastern University, 619 ISEC (Interdisciplinary Science and Engineering Complex), Boston, MA, 02115, USA.'}, {'ForeName': 'Kendrith', 'Initials': 'K', 'LastName': 'Rowland', 'Affiliation': 'Carle Foundation Hospital, 611 W Park St, Urbana, IL, 61801, USA.'}, {'ForeName': 'Dominick A', 'Initials': 'DA', 'LastName': 'Strom', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, 906 South Goodwin Ave, Urbana, IL, 61801, USA.'}, {'ForeName': 'Jaime N', 'Initials': 'JN', 'LastName': 'Wong', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, 906 South Goodwin Ave, Urbana, IL, 61801, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'McAuley', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, 906 South Goodwin Ave, Urbana, IL, 61801, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-020-00185-8']
3106,31356228,Reduced dose of cabazitaxel in metastatic castration-resistant prostate cancer: from PROSELICA trial to the real life: A single institution experience.,"The phase III PROSELICA trial showed that cabazitaxel 20 mg/m (C20) was not inferior and better tolerated compared to cabazitaxel 25 mg/m (C25) in patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed during or after docetaxel. Here, we report on a real-world retrospective analysis concerning the safety and the activity of C20 schedule in patients with mCRPC treated at our Institution. We identified 35 patients with mCRPC who received C20 as baseline dose treatment because they were frail or experienced serious toxicities to previous treatments. Adverse events assessment was performed at each visit during the treatment. Progression-free survival (PFS) and overall survival (OS) curves were obtained using the Kaplan-Meyer product-limit estimator. Median age was 71 years. All patients received a previous treatment with docetaxel; 19 patients (54%) received one additional line of therapy and 9 (26%) two or more. Patients received a median of 4 cycles (range: 2-10). Only one patient experienced grade 3 neutropenia (3%), two patients grade 3 anemia (6%), and one patient grade 3 fatigue (3%); three patients were treated with prophylactic Granulocyte colony-stimulating factor (9%). The most frequent adverse events of all grades were: anemia (39%), fatigue (33%), and diarrhea (15%). Median PFS was 3.7 months [95% confidence interval (CI): 3.31-4.09]; median OS was 10.3 months (95% CI: 4.63-15.97). Our real-world analysis confirms that C20 is a feasible option for elderly and heavily pretreated patients with mCRPC, showing activity and good tolerability.",2019,Progression-free survival (PFS) and overall survival,"['metastatic castration-resistant prostate cancer', 'patients with mCRPC treated at our Institution', 'patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed during or after', '35 patients with mCRPC who received']","['docetaxel', 'C20', 'cabazitaxel']","['diarrhea', 'Median PFS', 'serious toxicities', 'anemia', 'fatigue', 'grade 3 anemia', 'median OS', 'grade 3 neutropenia', 'Progression-free survival (PFS) and overall survival']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2830183', 'cui_str': 'cabazitaxel'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",3.0,0.0269434,Progression-free survival (PFS) and overall survival,"[{'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Vallome', 'Affiliation': 'Academic Unit of Medical Oncology, IRCCS San Martino Polyclinic Hospital.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cattrini', 'Affiliation': 'Department of Internal Medicine and Medical Specialties (DIMI), School of Medicine, University of Genoa, Genoa.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Messina', 'Affiliation': 'Medical Oncology Unit, Santa Chiara Hospital, Trento, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Cerbone', 'Affiliation': 'Department of Internal Medicine and Medical Specialties (DIMI), School of Medicine, University of Genoa, Genoa.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Department of Internal Medicine and Medical Specialties (DIMI), School of Medicine, University of Genoa, Genoa.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Zanardi', 'Affiliation': 'Academic Unit of Medical Oncology, IRCCS San Martino Polyclinic Hospital.'}]",Anti-cancer drugs,['10.1097/CAD.0000000000000805']
3107,31399364,Association Between Body Composition and Blood Glucose During Exercise and Recovery in Adolescent and Adult Patients With Type 1 Diabetes.,,2020,,['Adolescent and Adult Patients'],[],['Body Composition and Blood Glucose'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",,0.0175092,,"[{'ForeName': 'Semah', 'Initials': 'S', 'LastName': 'Tagougui', 'Affiliation': 'Institut de recherches cliniques de Montréal, Montréal, Québec, Canada; Department of Nutrition, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Goulet-Gelinas', 'Affiliation': 'Institut de recherches cliniques de Montréal, Montréal, Québec, Canada; Department of Nutrition, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Taleb', 'Affiliation': 'Institut de recherches cliniques de Montréal, Montréal, Québec, Canada; Division of Biomedical Sciences, Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Messier', 'Affiliation': 'Institut de recherches cliniques de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Suppere', 'Affiliation': 'Institut de recherches cliniques de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Rabasa-Lhoret', 'Affiliation': 'Institut de recherches cliniques de Montréal, Montréal, Québec, Canada; Department of Nutrition, Université de Montréal, Montréal, Québec, Canada. Electronic address: remi.rabasa-lhoret@ircm.qc.ca.'}]",Canadian journal of diabetes,['10.1016/j.jcjd.2019.05.013']
3108,31430369,Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I.,"OBJECTIVES


Studies 1878 and 1844 demonstrated non-inferior efficacy of switching suppressed HIV-1-infected adults to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) versus continuing boosted PI-based triple regimens or dolutegravir/abacavir/lamivudine (DTG/ABC/3TC). Here, detailed analyses of pre-existing resistance in the two BIC/FTC/TAF switch studies and efficacy at week 48 are described.
METHODS


Pre-existing resistance was assessed from historical genotypes (documented resistance to study drugs was excluded) and by retrospective baseline proviral archive DNA genotyping from whole blood. Outcomes were based on HIV-1 RNA at week 48 with missing values imputed using the last on-treatment observation carried forward method.
RESULTS


Cumulative pre-existing resistance data from historical and proviral genotypes were obtained for 95% (543/570) of participants who switched to BIC/FTC/TAF. Altogether, 40% (217/543) had one or more pre-existing primary resistance substitutions in protease, reverse transcriptase and/or integrase. Pre-switch NRTI resistance was detected in 16% (89/543) of BIC/FTC/TAF-treated participants, with M184V or M184I detected by proviral genotyping in 10% (54/543). At week 48, 98% (561/570) of all BIC/FTC/TAF-treated participants versus 98% (213/217) with pre-existing resistance and 96% (52/54) with archived M184V/I had HIV-1 RNA <50 copies/mL. No BIC/FTC/TAF-treated participants developed treatment-emergent resistance to study drugs.
CONCLUSIONS


Pre-existing resistance substitutions, notably M184V/I, were unexpectedly common among suppressed participants who switched to BIC/FTC/TAF. High rates of virological suppression were maintained in the overall study population and in those with pre-existing resistance, including M184V/I, for up to 48 weeks of BIC/FTC/TAF treatment with no resistance development. These results indicate that BIC/FTC/TAF is an effective treatment option for suppressed patients, including those with evidence of archived NRTI resistance.",2019,"High rates of virological suppression were maintained in the overall study population and in those with pre-existing resistance, including M184V/I, for up to 48 weeks of BIC/FTC/TAF treatment with no resistance development.",['participants with archived antiretroviral resistance including M184V/I'],"['bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF', 'BIC/FTC/TAF', 'bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1', 'dolutegravir/abacavir/lamivudine (DTG/ABC/3TC']","['RNA suppression', 'Pre-switch NRTI resistance', 'High rates of virological suppression']","[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4542162', 'cui_str': 'emtricitabine, tenofovir alafenamide and bictegravir'}, {'cui': 'C0063382', 'cui_str': 'imidazole mustard'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}, {'cui': 'C1450557', 'cui_str': 'IGFBP7 protein, human'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1613391', 'cui_str': 'lamivudine and abacavir'}]","[{'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}]",1878.0,0.0560156,"High rates of virological suppression were maintained in the overall study population and in those with pre-existing resistance, including M184V/I, for up to 48 weeks of BIC/FTC/TAF treatment with no resistance development.","[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Andreatta', 'Affiliation': 'Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Willkom', 'Affiliation': 'Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.'}, {'ForeName': 'Ya-Pei', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.'}, {'ForeName': 'Hiba', 'Initials': 'H', 'LastName': 'Graham', 'Affiliation': 'Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Quirk', 'Affiliation': 'Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'White', 'Affiliation': 'Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz347']
3109,31430524,How making decisions for children affects the food choices of adults.,"Parents and other adults such as baby sitters, daycare workers, and teachers are responsible for making choices that contribute to the development and well-being of the children in their care. In a typical day, for example, parents decide what and how much their children eat, the amount of time they spend online, the television programs they watch, and the time they go to bed. In this research, we identify two common approaches -imposition and accommodation-that are available to decision makers and outline how these decisions affect the feelings of power and eating behaviors of the adults themselves. Four experiments and one field study demonstrate that adults shape their own consumption choices based on whether they accommodate the virtuous (i.e. healthy) vs. indulgent (i.e. unhealthy) preferences of the child or impose their own preferences. We find that when adults accommodate the child's preferences, they choose healthier foods for themselves. Finally, we demonstrate that the social context of consumption moderates these effects. We find support for our power-based theory in five studies using a variety of methods, participants, and contexts. The results have important implications for the health of adults who take care of children.",2019,"Parents and other adults such as baby sitters, daycare workers, and teachers are responsible for making choices that contribute to the development and well-being of the children in their care.",['adults who take care of children'],[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",[],[],,0.031028,"Parents and other adults such as baby sitters, daycare workers, and teachers are responsible for making choices that contribute to the development and well-being of the children in their care.","[{'ForeName': 'Utku', 'Initials': 'U', 'LastName': 'Akkoc', 'Affiliation': 'Alberta School of Business, University of Alberta, 11211 Saskatchewan Drive NW, Edmonton, AB, Canada, T6G 2R6. Electronic address: akko@ualberta.ca.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fisher', 'Affiliation': 'Alberta School of Business, University of Alberta, 11211 Saskatchewan Drive NW, Edmonton, AB, Canada, T6G 2R6.'}]",Appetite,['10.1016/j.appet.2019.104407']
3110,31437472,"Choosing or rejecting a food item, does framing matter? And what has sugar to do with it!","The color code of ""Traffic Light Labels"" (TLL) on food items indicates the amount (e.g., green = low) of fat, saturates, sugar and salt it contains. Consider two ways to select among food items (e.g., two cereal bars) based on their TLLs. You might choose between the two items or you might reject one of the two. Furthermore, differences between choose and reject might be driven more strongly by one factor (e.g., sugar) than by others. In Study 1 our participants made choose or reject decisions between food items with an all-orange TLL (all moderate) and a 2 red/2 green TLL (2 negative/2 positive). Both items had equal energy/caloric content. We found that, independent of the condition (Choose/Reject), participants went home more often with the 2 red/2 green item if sugar was green. This effect was stronger in the Choose than in the Reject condition. In Study 2, we additionally manipulated the energy content (low, high) of the items. In the case where both food items had a low energy content, similar results as in Study 1 were observed. If either or both items had high energy content, the choose/reject interaction with sugar disappeared. Only differences in energy content played a role in the reject condition. Overall, our results can be better explained by an ""accentuation hypothesis"" than by a ""compatibility hypothesis"". These findings could be used by choice architects to fight the current obesity crisis.",2019,"We found that, independent of the condition (Choose/Reject), participants went home more often with the 2 red/2 green item if sugar was green.",[],[],[],[],[],[],1.0,0.0188278,"We found that, independent of the condition (Choose/Reject), participants went home more often with the 2 red/2 green item if sugar was green.","[{'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Reijnen', 'Affiliation': 'Zurich University of Applied Sciences, Switzerland. Electronic address: ester.reijnen@zhaw.ch.'}, {'ForeName': 'Swen J', 'Initials': 'SJ', 'LastName': 'Kühne', 'Affiliation': 'Zurich University of Applied Sciences, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Stöcklin', 'Affiliation': 'University of Basel, Switzerland.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Wolfe', 'Affiliation': ""Brigham & Women's Hospital, Boston, USA; Harvard Medical School, Boston, USA.""}]",Appetite,['10.1016/j.appet.2019.104410']
3111,31465810,Impact of a front-of-pack nutritional traffic-light label on the nutritional quality and the hedonic value of mid-afternoon snacks chosen by mother-child dyads.,"The aim of this study was to assess the impact of a nutritional traffic-light label, the Nutri-Score, on snack choices in mother-child dyads and to assess a potential hedonic cost associated with a change in favour of healthier choices. French mothers and children (n = 95; children's age: 7-11 years) who participated were asked to choose, for themselves and for the other dyad member, a snack composed of one beverage and two food items selected among several products with different nutritional quality. In the first step, the products were presented without any information. In the second step, the products were labelled with the Nutri-Score. Mothers and children were asked to rate their liking for all proposed products before being informed of their nutritional quality. The nutritional quality, the hedonic score, and the estimated budget of the selected snacks were compared before and after labelling. As hypothesized, the Nutri-Score label led to a significant increase in the nutritional quality of the chosen snacks. The budget for the chosen snacks was unchanged or decreased after the nutritional labelling was applied. Children and mothers had significantly lower liking for the snacks after nutritional labelling than before nutritional labelling, suggesting a hedonic cost associated with a change in favour of healthier snack choices. This raises the question of the sustainability of the behavioural change induced by the Nutri-Score label.",2019,"Children and mothers had significantly lower liking for the snacks after nutritional labelling than before nutritional labelling, suggesting a hedonic cost associated with a change in favour of healthier snack choices.","[""French mothers and children (n\u202f=\u202f95; children's age: 7-11 years) who participated were asked to choose, for themselves and for the other dyad member, a snack composed of one beverage and two food items selected among several products with different nutritional quality"", 'mid-afternoon snacks chosen by mother-child dyads', 'mother-child dyads', 'Mothers and children']","['nutritional traffic-light label, the Nutri-Score', 'front-of-pack nutritional traffic-light label']","['nutritional quality', 'nutritional quality, the hedonic score, and the estimated budget of the selected snacks']","[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}]","[{'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}]","[{'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}]",95.0,0.0168548,"Children and mothers had significantly lower liking for the snacks after nutritional labelling than before nutritional labelling, suggesting a hedonic cost associated with a change in favour of healthier snack choices.","[{'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Poquet', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, Agrosup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Ginon', 'Affiliation': 'CEREN, EA 7477, Burgundy School of Business, Université Bourgogne Franche-Comté, F-21000, Dijon, France.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Goubel', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, Agrosup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chabanet', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, Agrosup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'Stéphan', 'Initials': 'S', 'LastName': 'Marette', 'Affiliation': 'UMR Economie Publique, INRA AgroParisTech, Université Paris-Saclay, F-78850, Grignon, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Issanchou', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, Agrosup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000, Dijon, France.""}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Monnery-Patris', 'Affiliation': ""Centre des Sciences du Goût et de l'Alimentation, Agrosup Dijon, CNRS, INRA, Université Bourgogne Franche-Comté, F-21000, Dijon, France. Electronic address: sandrine.monnery-patris@inra.fr.""}]",Appetite,['10.1016/j.appet.2019.104425']
3112,31472201,Dynamics of attentional bias for food in Dutch and Chinese children and the role of executive control.,,2019,,['Dutch and Chinese children'],[],[],"[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],[],,0.0213475,,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands. Electronic address: yu.liu@maastrichtuniversity.nl.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Nederkoorn', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Roefs', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}]",Appetite,['10.1016/j.appet.2019.104421']
3113,32979188,The Effects of Midline Cerebellar rTMS on Human Pharyngeal Cortical Activity in the Intact Swallowing Motor System.,"We sought to compare the effects of 10 Hz cerebellar vermis (vs. unilateral hemispheric and sham) repetitive transcranial magnetic stimulation (rTMS) on cortical neuroelectrical activity and thereafter 10 Hz cerebellar vermis (vs. sham) rTMS on swallowing behaviour. Healthy participants (n = 25) were randomly allocated to receive vermis, unilateral hemisphere or sham 10 Hz cerebellar rTMS. Recordings were made using pharyngeal electromyography and manometry catheters, obtaining motor-evoked potentials (MEPs) and pressure recordings. The amplitudes of MEPs elicited using single-pulse TMS delivered to the pharyngeal areas of the motor cortex bilaterally were measured pre- and post-cerebellar stimulation. As in previous studies, abductor policis brevis (APB) MEPs were measured to assess post-rTMS modulation specificity. Swallowing was assessed using a swallowing accuracy task. Measurements were made at baseline and 15-min intervals for an hour post-intervention. Measurements involved TMS being used to elicit 10 MEPs bilaterally over the pharyngeal areas of the motor cortex, over the APB cortical representation adjacent to the pharyngeal area with the lowest resting motor threshold and 5 MEPs bilaterally over pharyngeal areas of the cerebellar hemispheres. Swallowing accuracy was assessed by giving participants 10 attempts to swallow and hit a digital target. Cerebellar vermis rTMS caused significant suppression of cortical pharyngeal MEP amplitudes compared with unilateral rTMS and sham (P = 0.0005, 0.002). APB and cerebellar MEP amplitudes were unaffected as were pharyngeal and APB MEP latencies. Following cerebellar vermis rTMS there was a significant reduction in swallowing accuracy compared with sham (P = 0.001). Our findings demonstrate cerebellar vermis rTMS exerts a suppressive effect on pharyngeal motor cortical activity and swallowing behaviour.",2020,"Cerebellar vermis rTMS caused significant suppression of cortical pharyngeal MEP amplitudes compared with unilateral rTMS and sham (P = 0.0005, 0.002).",['Healthy participants (n = 25'],"['Midline Cerebellar rTMS', 'pharyngeal electromyography and manometry catheters, obtaining motor-evoked potentials (MEPs) and pressure recordings', '10 Hz cerebellar vermis (vs. unilateral hemispheric and sham) repetitive transcranial magnetic stimulation (rTMS', 'unilateral hemisphere or sham 10 Hz cerebellar rTMS']","['cortical pharyngeal MEP amplitudes', 'pharyngeal and APB MEP latencies', 'Swallowing', 'swallowing accuracy', 'APB and cerebellar MEP amplitudes', 'cortical neuroelectrical activity', 'abductor policis brevis (APB) MEPs', 'Swallowing accuracy', 'pharyngeal motor cortical activity and swallowing behaviour', 'Human Pharyngeal Cortical Activity', 'swallowing behaviour']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0941139', 'cui_str': 'Manometer catheter'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0228482', 'cui_str': 'Cerebellar vermis structure'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]",25.0,0.0733807,"Cerebellar vermis rTMS caused significant suppression of cortical pharyngeal MEP amplitudes compared with unilateral rTMS and sham (P = 0.0005, 0.002).","[{'ForeName': 'Ayodele', 'Initials': 'A', 'LastName': 'Sasegbon', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), University of Manchester, Salford, UK. ayodele.sasegbon@manchester.ac.uk.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Niziolek', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), University of Manchester, Salford, UK.'}, {'ForeName': 'Mengqing', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), University of Manchester, Salford, UK.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Smith', 'Affiliation': 'Manchester Centre for Clinical Neurosciences, Division of Cardiovascular Sciences, Lydia Becker Institute of Immunology and Inflammation, Salford Royal Hospital, Manchester Academic Health Sciences Centre (MAHSC), University of Manchester, Salford, UK.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rothwell', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, University College London, London, UK.'}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Hamdy', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, School of Medical Sciences, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), University of Manchester, Salford, UK.'}]","Cerebellum (London, England)",['10.1007/s12311-020-01191-x']
3114,32979230,Two randomized controlled trials of the efficacy of acceptance and commitment therapy-based educational course for body shape dissatisfaction.,"The main aim of this project was to explore the efficacy of Acceptance and Commitment Therapy (ACT)-based educational course in different formats (i.e., pure and guided self-help with different durations, and guided self-help with and without access to a discussion forum) for body shape dissatisfaction. Two randomized controlled studies (RCT) were carried out. In the first RCT, the participants were randomized to a 12- or 16-week guided self-help, a 16-week pure self-help, or a waitlist control condition. In the second RCT, the efficacy of 12-week guided self-help with or without access to a discussion forum was investigated. ACT-based self-help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life). The findings also showed no additional effects of support, access to the online discussion forum, and longer duration of self-help, suggesting the 12-week self-help with or without support is a viable option for reducing body shape dissatisfaction.",2020,"ACT-based self-help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life).",[],['acceptance and commitment therapy-based educational course'],"['general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life']",[],"[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0447353,"ACT-based self-help resulted in promising improvements in body shape dissatisfaction, and modest effects on general health indicators (i.e., symptom of depression, self-esteem, satisfaction with life, and quality of life).","[{'ForeName': 'Kerim', 'Initials': 'K', 'LastName': 'Selvi', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parling', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Welch', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Scandinavian journal of psychology,['10.1111/sjop.12684']
3115,32979235,Time to relapse after tildrakizumab withdrawal in patients with moderate-to-severe psoriasis who were responders at week 28: post-hoc analysis through 64 weeks from reSURFACE 1 trial.,"BACKGROUND


As treatment interruptions occur during psoriasis management in clinical practice, it is important to know the duration of clinical response after treatment withdrawal.
OBJECTIVES


To report time to and predictors of relapse in patients who were tildrakizumab 100 and 200 mg responders (≥75% improvement in Psoriasis Area and Severity Index; PASI 75) at week 28 re-randomized to placebo from reSURFACE 1 trial.
METHODS


Post-hoc analysis of adult patients with moderate-to-severe plaque psoriasis from a 64-week phase 3 trial. Relapse was primarily defined as loss of PASI 75 response. Both relapse defined as loss of PASI 90 and loss of absolute PASI <2 response were included as sensitivity analyses. PASI 75, PASI 90, and PASI <2 responders re-randomized to placebo at week 28 and followed-up until week 64 were included. Kaplan-Meier (KM) estimates of the 64-week relapse rate were calculated. Log-rank test to compare KM curves from responders to tildrakizumab 100 and 200 mg was used. Independent predictors of relapse were explored.
RESULTS


Median time to loss of PASI 75/PASI 90/PASI <2 response from week 28 was 142/111/112 days with tildrakizumab 100 mg and 172/140/113 days with tildrakizumab 200 mg, respectively (all not significant). Around 20% of patients did not relapse (either maintained a PASI 75 response or were lost to follow-up) during the 36-week period. Increase in body mass index (BMI) (hazard ratio, HR [95% confidence interval, CI] for loss of PASI 75 response: 1.0345 [1.0112 - 1.0582]) and increase in disease duration (HR [95% CI]: 1.0151 [1.0028 - 1.0275] for loss of PASI 75 response) were associated with an increased risk of relapse, regardless of the relapse definition.
CONCLUSIONS


When treatment is interrupted, tildrakizumab provides durable maintenance of efficacy with a median time to loss of PASI 75 response of five to six months, irrespective of the dose. Interventions on modifiable risk factors for relapse, such as BMI, may improve personalized long-term psoriasis management.",2020,Around 20% of patients did not relapse (either maintained a PASI 75 response or were lost to follow-up) during the 36-week period.,"['adult patients with moderate-to-severe plaque psoriasis from a 64-week phase 3 trial', 'patients who were tildrakizumab 100 and 200 mg responders (≥75% improvement in Psoriasis Area and Severity Index; PASI 75) at week 28 re-randomized to', 'patients with moderate-to-severe psoriasis']","['placebo', 'tildrakizumab']","['disease duration', 'Kaplan-Meier (KM) estimates of the 64-week relapse rate', 'body mass index (BMI) (hazard ratio, HR', 'risk of relapse, regardless of the relapse definition', 'Relapse', 'Median time to loss of PASI 75/PASI 90/PASI']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4043954', 'cui_str': 'tildrakizumab'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.124221,Around 20% of patients did not relapse (either maintained a PASI 75 response or were lost to follow-up) during the 36-week period.,"[{'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, U.K.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Carrascosa', 'Affiliation': 'Department of Dermatology, Germans Trias, Pujol University Hospital (HUGTP), Autonomous University of Barcelona (UAB), Badalona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fumero', 'Affiliation': 'Almirall R&D, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schoenenberger', 'Affiliation': 'Almirall R&D, Barcelona, Spain.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, U.S.A.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Szepietowski', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Skinflammation, ® Center, Hamburg, Germany.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16964']
3116,32979249,COVID-19: Comparing the applicability of shared room and single room occupancy.,"To curb the COVID-19 pandemic, isolation measures are required. Shared room occupancy is recommended when isolation rooms are insufficient. However, there is little evidence of the applicability of shared and single room occupancy for patients with COVID-19 to determine whether shared room occupancy is feasible. COVID-19 patients admitted to the Daegu Dongsan Hospital of Keimyung University from 21 st  February 2020 to 20 th  April 2020 were enrolled in the study and randomly assigned to hospital rooms. Clinical symptoms, underlying diseases, and epidemiological data of patients were analyzed after dividing participants into a shared room occupancy group (group A) and a single room occupancy group (group B). Outcomes analyzed included microbiological cure rates, time to clinical symptom improvement, time to defervescence, and negative-to-positive conversion rates of polymerase chain reaction (PCR) results during hospitalization. A total of 666 patients were included in this study, 535 and 131 patients in groups A and B, respectively. Group B included more underlying conditions, such as pregnancy and solid organ transplantation, and was more closely associated with severe pneumonia during hospitalization. Besides, no statistically significant differences between the two groups in terms of negative PCR rates at HD 7 and 14, conversion rates of PCR results from negative-to-positive, as well as time to the improvement of clinical symptoms, and time to defervescence were observed. Our results suggest that the shared room occupancy of patients with mild symptoms could be an alternative to single room occupancy during the COVID-19 pandemic.",2020,"Besides, no statistically significant differences between the two groups in terms of negative PCR rates at HD 7 and 14, conversion rates of PCR results from negative-to-positive, as well as time to the improvement of clinical symptoms, and time to defervescence were observed.","['COVID-19 patients admitted to the Daegu Dongsan Hospital of Keimyung University from 21 st  February 2020 to 20 th  April 2020 were enrolled in the study and randomly assigned to hospital rooms', 'A total of 666 patients were included in this study, 535 and 131 patients in groups A and B, respectively']",['COVID-19'],"['clinical symptoms, and time to defervescence', 'negative PCR rates', 'microbiological cure rates, time to clinical symptom improvement, time to defervescence, and negative-to-positive conversion rates of polymerase chain reaction (PCR) results during hospitalization']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",666.0,0.034077,"Besides, no statistically significant differences between the two groups in terms of negative PCR rates at HD 7 and 14, conversion rates of PCR results from negative-to-positive, as well as time to the improvement of clinical symptoms, and time to defervescence were observed.","[{'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Hyun', 'Affiliation': 'Division of Infectious Diseases, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Yong Shik', 'Initials': 'YS', 'LastName': 'Kwon', 'Affiliation': 'Division of Pulmonology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Division of Radiology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Jae Suck', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonology, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Sunggyun', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Division of Laboratory Medicine, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Namhee', 'Initials': 'N', 'LastName': 'Ryoo', 'Affiliation': 'Division of Laboratory Medicine, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Hyun Ah', 'Initials': 'HA', 'LastName': 'Kim', 'Affiliation': 'Division of Infectious Diseases, Keimyung University Dongsan Hospital, Keimyung University School of Medicine, Daegu, South Korea.'}]",Transboundary and emerging diseases,['10.1111/tbed.13853']
3117,31657024,Phase 1 study of crisaborole in Japanese healthy volunteers and patients with atopic dermatitis.,"Crisaborole ointment, 2%, is a non-steroidal phosphodiesterase 4 inhibitor for the treatment of mild to moderate atopic dermatitis (AD). This parallel-cohort, phase 1 study was conducted to investigate skin irritation potential and safety of crisaborole in healthy Japanese adults (cohort 1) and the safety and pharmacokinetic profile of crisaborole and metabolites AN7602 and AN8323 in Japanese adults with mild to moderate AD (cohort 2). In cohort 1, 20 healthy volunteers received single applications of crisaborole and vehicle simultaneously on separate locations under 48-h occlusion. In cohort 2, 12 patients with mild to moderate AD received crisaborole (n = 10) or vehicle (n = 2) twice daily for 8 days. Skin irritation and safety were assessed in cohort 1. Pharmacokinetics and safety were assessed in cohort 2. Skin irritation index (scale 0-400) was 40.0 for crisaborole and 5.0 for vehicle. No treatment-emergent adverse events (TEAE) were reported in cohort 1. The most common TEAE in the crisaborole group in cohort 2 were application site irritation (n = 7) and application site pain (n = 4). Crisaborole was rapidly absorbed, with limited systemic exposure between days 1 and 8 that was comparable with that seen in US-based participants in previous trials. Crisaborole had higher skin irritation than vehicle under occlusion in healthy Japanese adults and had an acceptable safety profile in Japanese adults with mild to moderate AD.",2020,Crisaborole had higher skin irritation than vehicle under occlusion in healthy Japanese adults and had an acceptable safety profile in Japanese adults with mild to moderate AD.,"['Japanese healthy volunteers and patients with atopic dermatitis', 'mild to moderate atopic dermatitis (AD', '12 patients with mild to moderate AD', 'healthy Japanese adults', '20 healthy volunteers', 'healthy Japanese adults (cohort 1', 'Japanese adults with mild to moderate AD (cohort 2', 'Japanese adults with mild to moderate AD']","['Crisaborole', 'crisaborole and metabolites AN7602 and AN8323', 'Crisaborole ointment', 'crisaborole']","['application site pain', 'application site irritation', 'skin irritation', 'Skin irritation index', 'Pharmacokinetics and safety', 'Skin irritation and safety']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C4301781', 'cui_str': 'crisaborole'}, {'cui': 'C4301784', 'cui_str': 'crisaborole Topical Ointment'}]","[{'cui': 'C0521491', 'cui_str': 'Application site pain'}, {'cui': 'C0521490', 'cui_str': 'Application site irritation'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",20.0,0.0791412,Crisaborole had higher skin irritation than vehicle under occlusion in healthy Japanese adults and had an acceptable safety profile in Japanese adults with mild to moderate AD.,"[{'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Ono', 'Affiliation': 'Clinical Pharmacology, Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Yagi', 'Affiliation': 'OPHAC Hospital, Osaka, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Shoji', 'Affiliation': 'Department of Dermatology, Ikeda Kaisei Hospital, Osaka, Japan.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Clinical Research, Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Clinical Statistics, Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Ports', 'Affiliation': 'Inflammation & Immunology, Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Vivek S', 'Initials': 'VS', 'LastName': 'Purohit', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA.'}]",The Journal of dermatology,['10.1111/1346-8138.15123']
3118,31883728,Salt-sensitive blood pressure rise in type 1 diabetes patients is accompanied by disturbed skin macrophage influx and lymphatic dilation-a proof-of-concept study.,"Type 1 diabetes patients are more prone to have hypertension than healthy individuals, possibly mediated by increased blood pressure (BP) sensitivity to high salt intake. The classical concept proposes that the kidney is central in salt-mediated BP rises, by insufficient renal sodium excretion leading to extracellular fluid volume expansion. Recent animal-derived findings, however, propose a causal role for disturbance of macrophage-mediated lymphangiogenesis. Its relevance for humans, specifically type 1 diabetes patients, is unknown. The present study aimed to assess responses of type 1 diabetes patients to a dietary salt load with regard to BP, extracellular fluid volume (using precise iohexol measurements), and CD163+ macrophage and lymphatic capillary density in skin biopsies. Also, macrophage expression of HLA-DR (a proinflammatory marker) and CD206 (an anti-inflammatory marker) was assessed. Type 1 diabetes patients (n = 8) showed a salt-sensitive BP increase without extracellular fluid volume expansion. Whereas healthy controls (n = 12), who had no BP increase, showed increased skin CD163+ and HLA-DR+ macrophages and dilation of lymphatic skin vasculature after the dietary salt load, these changes were absent (and in case of HLA-DR more heterogenic) in type 1 diabetes patients. In conclusion, we show that salt sensitivity in type 1 diabetes patients cannot be explained by the classical concept of extracellular fluid volume expansion. Rather, we open up a potential role for macrophages and the lymphatic system. Future studies on hypertension and diabetes need to scrutinize these phenomena.",2020,"Also, macrophage expression of HLA-DR (a proinflammatory marker) and CD206 (an anti-inflammatory marker) was assessed.","['type 1 diabetes patients', 'Type 1 diabetes patients']",[],"['blood pressure (BP) sensitivity', 'salt-sensitive BP increase without extracellular fluid volume expansion', 'skin CD163+ and HLA-DR+ macrophages and dilation of lymphatic skin vasculature', 'macrophage expression of HLA-DR (a proinflammatory marker) and CD206 (an anti-inflammatory marker']","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0497247', 'cui_str': 'Elevated blood pressure'}, {'cui': 'C0015349', 'cui_str': 'Extracellular fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0251113', 'cui_str': 'CD163 antigen'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0019764', 'cui_str': 'HLA-DR antigen'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]",,0.0122699,"Also, macrophage expression of HLA-DR (a proinflammatory marker) and CD206 (an anti-inflammatory marker) was assessed.","[{'ForeName': 'Eliane F E', 'Initials': 'EFE', 'LastName': 'Wenstedt', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Academic Medical Center, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Rik H', 'Initials': 'RH', 'LastName': 'Olde Engberink', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Academic Medical Center, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Nienke M G', 'Initials': 'NMG', 'LastName': 'Rorije', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Academic Medical Center, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Department of Internal Medicine, Section of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Nike', 'Initials': 'N', 'LastName': 'Claessen', 'Affiliation': 'Department of Pathology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Aten', 'Affiliation': 'Department of Pathology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Internal Medicine, Section of Nephrology, Academic Medical Center, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands. Electronic address: l.vogt@amsterdamumc.nl.'}]",Translational research : the journal of laboratory and clinical medicine,['10.1016/j.trsl.2019.12.001']
3119,32046865,Identifying early postoperative serum parathyroid hormone levels as predictors of hypocalcaemia after total thyroidectomy: A prospective non-randomized study.,"OBJECTIVE


There is no clear cut-off value of serum parathyroid hormone (PTH) or calcium in which patients are at risk for hypocalcemia after total thyroidectomy. We evaluated the usefulness of serum calcium and PTH concentration measurements after total thyroidectomy in predicting late-occurring hypocalcemia.
DESIGN


A prospective, single-center, non-randomized longitudinal cohort study of 143 patients undergoing thyroidectomy between August 2019 and December 2019 with serum calcium and PTH levels sampled 1 h after surgery and on the first and fifth postoperative day. Hypocalcemia was defined as serum calcium levels < 2.14 mmol/L regardless of clinical symptoms. Normal PTH range was 1.6-6.9 pmol/L.
MEASUREMENTS


The primary outcome measure was presence of hypocalcemia on the first and fifth postoperative day, analyzed by a logistic regression model. The PTH cut-off value for prediction of hypocalcemia was identified using a ROC curve comparing all three time points using the Youden J index.
RESULTS


Out of 143 patients, 52 (36.4%) had hypocalcemia on the fifth postoperative day. Advanced age, concomitant neck dissection and serum PTH levels < 2.9 pmol/L 1 h after surgery and on the first postoperative surgery day were associated with a high risk of hypocalcemia on the first and fifth postoperative day and need for higher doses of calcium supplements (P < 0.0001, AUC 0.748, 95% CI 0.669-0.817, with 76.92% sensitivity and 71.43% specificity).
CONCLUSION


Serum PTH level measured immediately postoperatively and on the first postoperative day is a reliable predictor of postoperative hypocalcemia with important clinical implications.",2020,"Advanced age, concomitant neck dissection and serum PTH levels < 2.9 pmol/L 1 h after surgery and on the first postoperative surgery day were associated with a high risk of hypocalcemia on the first and fifth postoperative day and need for higher doses of calcium supplements (P < 0.0001, AUC 0.748, 95% CI 0.669-0.817, with 76.92% sensitivity and 71.43% specificity).
","['hypocalcaemia after total thyroidectomy', '143 patients undergoing thyroidectomy between August 2019 and December 2019 with serum calcium and PTH levels sampled 1\u202fh after surgery and on the first and fifth postoperative day']",[],"['presence of hypocalcemia on the first and fifth postoperative day', 'Advanced age, concomitant neck dissection and serum PTH levels', 'high risk of hypocalcemia', 'Hypocalcemia', 'serum calcium levels', 'hypocalcemia', 'serum parathyroid hormone (PTH) or calcium']","[{'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],"[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}]",143.0,0.0298517,"Advanced age, concomitant neck dissection and serum PTH levels < 2.9 pmol/L 1 h after surgery and on the first postoperative surgery day were associated with a high risk of hypocalcemia on the first and fifth postoperative day and need for higher doses of calcium supplements (P < 0.0001, AUC 0.748, 95% CI 0.669-0.817, with 76.92% sensitivity and 71.43% specificity).
","[{'ForeName': 'Andro', 'Initials': 'A', 'LastName': 'Košec', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Centre ""Sestre milosrdnice"", Vinogradska 29, 10000 Zagreb, Croatia; School of Medicine, University of Zagreb, Šalata 2b, 10000 Zagreb, Croatia. Electronic address: andro.kosec@yahoo.com.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Hergešić', 'Affiliation': 'School of Medicine, University of Zagreb, Šalata 2b, 10000 Zagreb, Croatia.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Matovinović', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Centre ""Sestre milosrdnice"", Vinogradska 29, 10000 Zagreb, Croatia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Rašić', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Centre ""Sestre milosrdnice"", Vinogradska 29, 10000 Zagreb, Croatia; School of Medicine, University of Zagreb, Šalata 2b, 10000 Zagreb, Croatia.'}, {'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Vagić', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Centre ""Sestre milosrdnice"", Vinogradska 29, 10000 Zagreb, Croatia; School of Medicine, University of Zagreb, Šalata 2b, 10000 Zagreb, Croatia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Bedeković', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Centre ""Sestre milosrdnice"", Vinogradska 29, 10000 Zagreb, Croatia; School of Medicine, University of Zagreb, Šalata 2b, 10000 Zagreb, Croatia.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102416']
3120,32112772,Repeatability of Scheimpflug Tomography for Assessing Fuchs Endothelial Corneal Dystrophy.,"PURPOSE


To determine if agreement between subjective interpretations of Scheimpflug tomography maps of corneas with Fuchs endothelial corneal dystrophy (FECD) is affected by daily and hourly changes in corneal edema.
DESIGN


Reliability analysis.
METHODS


Scheimpflug imaging pachymetry and posterior elevation maps of corneas with a range of severity of FECD were evaluated in a randomized manner for the presence of 3 tomographic features of edema. Agreement between interpretations of 1 masked observer was assessed (percentage, and κ-statistic with 95% confidence interval) for images taken within minutes on the same day, for images taken at a similar time on a different day, and for images taken over the course of a morning. Intra- and interobserver agreement was also assessed.
RESULTS


Interpretations for individual tomographic features agreed for ≥88% of images (κ ≥ 0.75) taken within minutes on the same day; complete disagreement (ie, disagreement for all 3 tomographic features in an image) occurred in ≤3% of images. Interpretations agreed for ≥77% of images (κ ≥ 0.52) taken at a similar time on a different day; complete disagreement did not occur. Interpretations agreed for ≥81% of images (κ ≥ 0.61) taken over the course of a morning; complete disagreement occurred in ≤6% of images. Intraobserver agreement was ≥93% (κ ≥ 0.83) and interobserver agreement was ≥93% (κ ≥ 0.66); complete disagreement did not occur.
CONCLUSIONS


Subjective interpretation of Scheimpflug images in FECD is highly repeatable for disease classification. Although small variations in interpretations resulted from pathophysiologic changes in corneal hydration and other factors, clinically significant disagreements in interpretation were uncommon and therefore unlikely to affect clinical decision-making.",2020,"RESULTS


Interpretations for individual tomographic features agreed for ≥88% of images (κ ≥ 0.75) taken within minutes on the same day; complete disagreement (ie, disagreement for all 3 tomographic features in an image) occurred in ≤3% of images.",['Scheimpflug imaging pachymetry and posterior elevation maps of corneas with a range of severity of FECD'],['Scheimpflug tomography maps of corneas with Fuchs endothelial corneal dystrophy (FECD'],[],"[{'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0016781', 'cui_str': ""Fuchs' corneal dystrophy""}]","[{'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0016781', 'cui_str': ""Fuchs' corneal dystrophy""}]",[],,0.0703418,"RESULTS


Interpretations for individual tomographic features agreed for ≥88% of images (κ ≥ 0.75) taken within minutes on the same day; complete disagreement (ie, disagreement for all 3 tomographic features in an image) occurred in ≤3% of images.","[{'ForeName': 'Sanjay V', 'Initials': 'SV', 'LastName': 'Patel', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota, USA. Electronic address: Patel.Sanjay@mayo.edu.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Hodge', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Treichel', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Spiegel', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Keith H', 'Initials': 'KH', 'LastName': 'Baratz', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.02.004']
3121,32979724,Sufficient vitamin D status positively modified ventilatory function in asthmatic children following a Mediterranean diet enriched with fatty fish intervention study.,"Asthma in children is the most prevalent allergic disease worldwide that has become a major public health priority. The objective of this study was to examine the relationship between baseline serum vitamin D status, spirometry, and fractional exhaled nitric oxide levels (FeNO) in 64 Greek children with 'mild asthma' aged 5 to 12 years (51.6% male) in a dietary intervention study. We hypothesized that baseline serum vitamin D levels modify the beneficial response of fatty fish intake on pulmonary function in asthmatic children following a Mediterranean diet. The intervention group consumed 2 fatty fish meals/week (≥150 g cooked filleted fish/meal) as part of the Mediterranean diet for six months, and the control group consumed their usual diet. Baseline serum 25(OH)D was determined using enzyme-linked immunoassay and defined as sufficient levels of 25(OH)D ≥25 ng/mL. Only 36% of children were graded as sufficient in 25(OH)D levels on entry into the study with a higher proportion of girls insufficient than boys (61% vs 39% respectively). Participants with sufficient levels of serum 25(OH)D at baseline, consuming the intervention diet increased FEV 1 /FVC by 4.89 units (β = 4.89; 95%CI: 1.19-8.61; p = 0.013) and FEF 25-75%  by 12.83 units (β = 12.83; 95%CI: 4.27-21.40; p = 0.006) compared to controls. No significant differences in pulmonary function or FeNO were observed for those with insufficient levels of 25(OH) D in the intervention or control groups. In conclusion, sufficient serum vitamin D levels enhanced ventilatory function in response to a dietary intervention in asthmatic children.",2020,No significant differences in pulmonary function or FeNO were observed for those with insufficient levels of 25(OH),"['asthmatic children', 'asthmatic children following a Mediterranean diet', ""64 Greek children with 'mild asthma' aged 5 to 12 years (51.6% male) in a dietary intervention study"", 'asthmatic children following a Mediterranean diet enriched with fatty fish intervention study']","['intervention group consumed 2 fatty fish meals/week (≥150 g cooked filleted fish/meal) as part of the Mediterranean diet for six months, and the control group consumed their usual diet']","['FEV 1 /FVC', 'baseline serum vitamin D status, spirometry, and fractional exhaled nitric oxide levels (FeNO', '25(OH', 'pulmonary function or FeNO', 'serum 25(OH)D', 'Baseline serum 25(OH)D']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",64.0,0.0417944,No significant differences in pulmonary function or FeNO were observed for those with insufficient levels of 25(OH),"[{'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Papamichael', 'Affiliation': 'La Trobe University, School of Allied Health, Human Services &Sport, Department of Dietetics, Nutrition & Sport, Melbourne, Australia. Electronic address: M.Papamichael@latrobe.edu.au.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Itsiopoulos', 'Affiliation': 'La Trobe University, School of Allied Health, Human Services &Sport, Department of Dietetics, Nutrition & Sport, Melbourne, Australia; Murdoch University, College of Science, Health, Engineering & Education, Perth, Australia. Electronic address: catherine.itsiopoulos@murdoch.edu.au.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Lambert', 'Affiliation': 'La Trobe University, School of Psychology & Public Health, Department of Public Health, Melbourne, Australia. Electronic address: k.lambert@latrobe.edu.au.'}, {'ForeName': 'Charis', 'Initials': 'C', 'LastName': 'Katsardis', 'Affiliation': 'National & Kapodistrian University of Athens, Athens, Greece. Electronic address: xkatsardis@med.uoa.gr.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Tsoukalas', 'Affiliation': 'European Institute of Nutritional Medicine, Rome, Italy. Electronic address: dtsoukalas@einum.org.'}, {'ForeName': 'Bircan', 'Initials': 'B', 'LastName': 'Erbas', 'Affiliation': 'La Trobe University, School of Psychology & Public Health, Department of Public Health, Melbourne, Australia. Electronic address: b.erbas@latrobe.edu.au.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.08.004']
3122,32979860,Fusidic acid cream comparatively minimizes signs of inflammation and postinflammatory hyperpigmentation after ablative fractional CO 2  laser resurfacing in Chinese patients: A randomized controlled trial.,"INTRODUCTION


Inflammation and postinflammatory hyperpigmentation (PIH) are two adverse side effects of ablative fractional CO 2  laser (ablative Fr CO 2  ) treatment for both rejuvenation and acne scars.
AIMS


To evaluate the efficacy of fusidic acid cream versus erythromycin ointment as postoperative therapy in patients who underwent ablative Fr CO 2  treatment for atrophic acne scars.
METHODS


Sixty Chinese patients who fulfilled the study criteria were recruited and randomly assigned to an experimental group treated with fusidic acid cream or a control group treated with erythromycin ointment. Postoperative treatment lasted for 7 days in each group. Each patient had two follow-up visits at 8- and 12-weeks. In total, three patients dropped out of the study, one in the experimental group at week 8 and two in the control group at weeks 8 and 12. Baseline and postoperative inflammation and PIH were assessed by facial examination, photographs, and questionnaires. Besides, PIH was evaluated by the Hyperpigmentation Activity and Severity Index (HASI) and a five-point grading system.
RESULTS


Moderate to severe PIH was observed in both groups. However, the mean HASI score and severity of PIH in the experimental group were lower than those of the control group at weeks 8 and 12 (P<0.05). In the control group, one patient developed postoperative abscesses and one had papules, whereas no inflammation was observed in the experimental group participants.
CONCLUSION


Fusidic acid cream shows promise as a common treatment after ablative FrCO 2  therapy to reduce postoperative inflammation and PIH.",2020,"CONCLUSION


Fusidic acid cream shows promise as a common treatment after ablative FrCO 2  therapy to reduce postoperative inflammation and PIH.","['Sixty Chinese patients who fulfilled the study criteria', 'Chinese patients', 'patients who underwent ablative Fr CO 2  treatment for atrophic acne scars']","['Fusidic acid cream', 'erythromycin ointment', 'fusidic acid cream']","['Hyperpigmentation Activity and Severity Index (HASI', 'Moderate to severe PIH', 'postoperative abscesses', 'mean HASI score and severity of PIH', 'no inflammation', 'Baseline and postoperative inflammation and PIH']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}]","[{'cui': 'C0016875', 'cui_str': 'fusidic acid'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C1248462', 'cui_str': 'Erythromycin Topical Ointment'}]","[{'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0919914', 'cui_str': 'Postoperative abscess'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",60.0,0.0210102,"CONCLUSION


Fusidic acid cream shows promise as a common treatment after ablative FrCO 2  therapy to reduce postoperative inflammation and PIH.","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Badachu Road, Number 33, Shijingshan District, Beijing, 100144, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Badachu Road, Number 33, Shijingshan District, Beijing, 100144, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Feng Zhang', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Badachu Road, Number 33, Shijingshan District, Beijing, 100144, China.'}, {'ForeName': 'Mengna', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Badachu Road, Number 33, Shijingshan District, Beijing, 100144, China.'}, {'ForeName': 'Baoxi', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Badachu Road, Number 33, Shijingshan District, Beijing, 100144, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Dermatology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Badachu Road, Number 33, Shijingshan District, Beijing, 100144, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13735']
3123,32979877,The fence technique: autogenous bone graft versus 50% deproteinized bovine bone matrix / 50% autogenous bone graft. A clinical double blind randomized controlled trial.,"OBJECTIVES


The aim of this short term double-blind, parallel, randomized clinical trial was to compare bone augmentation grafting with 100% autogenous bone (AB) or 50% deproteinized bovine bone matrix (DBBM) / 50% autogenous bone (BOAB) using a guided bone regeneration procedure, the fence technique, in a two-stage implant placement.
MATERIAL AND METHODS


Partially edentulous patients with extensive three-dimensional osseous defects were included in this study. The main outcome measure was the differences in bone volume from pre-surgery (T1) to 6 months post-surgery (T2). Bone height, chair-time, pain, functional limitation, and complications were also assessed.
RESULTS


Fifteen patients were allocated to the AB group and 15 patients to the BOAB group. The difference in bone volume from T1 to T2 was 648mm 3  for the AB group and 869mm 3  for the BOAB group (difference between groups 221mm 3  , 95% CI from -363 to 804, p=0.442). The surgery pain VAS was 1.6 for the AB group and 2.3 for the BOAB group (difference between groups 0.8, 95%CI from 0.0 to 1.5, p=0.045 favouring the AB group). The height difference in bone from T1 to T2 was 2.2mm for the AB group and 3.7 mm for the BOAB group (difference between groups 1.5mm, 95%CI from 0.1 to 2.9, p=0.038 favouring the BOAB group). For complications, chair-time, post-surgery pain and functional limitation there were no differences between AB and BOAB.
CONCLUSIONS


No significant differences, except for surgery pain VAS and difference in bone height were observed in this trial comparing grafting with AB or BOAB.",2020,"For complications, chair-time, post-surgery pain and functional limitation there were no differences between AB and BOAB.
","['Partially edentulous patients with extensive three-dimensional osseous defects', 'Fifteen patients were allocated to the AB group and 15 patients to the BOAB group']","['technique: autogenous bone graft versus 50% deproteinized bovine bone matrix / 50% autogenous bone graft', 'bone augmentation grafting with 100% autogenous bone (AB) or 50% deproteinized bovine bone matrix (DBBM) / 50% autogenous bone (BOAB']","['surgery pain VAS', 'For complications, chair-time, post-surgery pain and functional limitation', 'Bone height, chair-time, pain, functional limitation, and complications', 'bone height', 'bone volume']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005962', 'cui_str': 'Bone matrix'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0440800', 'cui_str': 'Autogenous bone graft'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0005962', 'cui_str': 'Bone matrix'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",15.0,0.291789,"For complications, chair-time, post-surgery pain and functional limitation there were no differences between AB and BOAB.
","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Merli', 'Affiliation': 'Clinica Merli, Rimini, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Nieri', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Mariotti', 'Affiliation': 'Clinica Merli, Rimini, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Merli', 'Affiliation': 'Clinica Merli, Rimini, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Franchi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Bernardo Quiroga', 'Initials': 'BQ', 'LastName': 'Souki', 'Affiliation': 'Program in Orthodontics, Pontifical Catholic University of Minas Gerais, Belo Horizonte, Brazil.'}]",Clinical oral implants research,['10.1111/clr.13670']
3124,32303468,Cost-Effectiveness of Switching Patients With Heart Failure and Reduced Ejection Fraction to Sacubitril/Valsartan: The Australian Perspective.,"BACKGROUND


The cost-effectiveness, from the Australian health care perspective, of switching patients with heart failure and reduced ejection fraction (HFREF) stable on angiotensin converting enzyme (ACE) inhibitors/angiotensin II receptor blockers (ARBs) to the angiotensin receptor neprilysin inhibitor (ARNi) sacubitril/valsartan is unclear. We sought to assess the cost-effectiveness of sacubitril/valsartan versus enalapril in patients with HFREF in the contemporary Australian setting.
METHODS


We developed a Markov model with two health states ('Alive' and 'Dead') to assess the cost-effectiveness of sacubitril/valsartan versus enalapril in patients with HFREF. Model subjects were 63 years of age at entry and had simulated follow-up over 20 years. Transition probabilities were derived from the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure (PARADIGM-HF) study. Costs and utility data were derived from published sources. All costs and effects were discounted at an annual rate of 5% and are presented in Australian dollars. Sensitivity analyses were undertaken to test variability in key data inputs.
RESULTS


In the base-case analysis, sacubitril/valsartan was found to reduce non-fatal heart failure hospitalisations and cardiovascular deaths, with numbers-needed-to-treat over a 20-year period of 40 and 27, respectively. The use of sacubitril/valsartan led to an additional 6 months of life gained per patient, translating to A$27,954 per years of life saved (YoLS) and A$40,513 per quality-adjusted-life-years (QALY) gained. The results of the sensitivity analyses indicated that the results were robust.
CONCLUSIONS


Our analysis supports switching HFREF patients on ACE inhibitor or ARB to sacubitril/valsartan.",2020,"In the base-case analysis, sacubitril/valsartan was found to reduce non-fatal heart failure hospitalisations and cardiovascular deaths, with numbers-needed-to-treat over a 20-year period of 40 and 27, respectively.","['Model subjects were 63 years of age at entry and had simulated follow-up over 20 years', 'patients with HFREF in the contemporary Australian setting', 'switching patients with heart failure and reduced ejection fraction (HFREF) stable on', 'patients with HFREF']","['sacubitril/valsartan', 'angiotensin converting enzyme (ACE) inhibitors/angiotensin II receptor blockers (ARBs', 'Sacubitril/Valsartan', 'valsartan', 'sacubitril/valsartan versus enalapril', 'enalapril']","['cost-effectiveness', 'Cost-Effectiveness', 'reduce non-fatal heart failure hospitalisations and cardiovascular deaths', 'Global Mortality and morbidity']","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0022709', 'cui_str': 'Dipeptidyl carboxypeptidase I'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0362592,"In the base-case analysis, sacubitril/valsartan was found to reduce non-fatal heart failure hospitalisations and cardiovascular deaths, with numbers-needed-to-treat over a 20-year period of 40 and 27, respectively.","[{'ForeName': 'Ken Lee', 'Initials': 'KL', 'LastName': 'Chin', 'Affiliation': 'CCRE Therapeutics, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Vic, Australia; Melbourne Medical School, The University of Melbourne, Melbourne, Vic, Australia.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Zomer', 'Affiliation': 'CCRE Therapeutics, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Vic, Australia.'}, {'ForeName': 'Bing H', 'Initials': 'BH', 'LastName': 'Wang', 'Affiliation': 'CCRE Therapeutics, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Vic, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'CCRE Therapeutics, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Vic, Australia. Electronic address: danny.liew@monash.edu.'}]","Heart, lung & circulation",['10.1016/j.hlc.2019.03.007']
3125,32979515,A dyadic approach for a remote physical activity intervention in adults with Alzheimer's disease and their caregivers: Rationale and design for an 18-month randomized trial.,"Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA). Options for increasing MPA in community dwelling adults with ADRD and their caregivers are limited. A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group. We will conduct an 18-month randomized trial (6 mos. Active intervention, 6 mos. Maintenance, 6 mos. no contact) to compare the effectiveness of the RGV approach with usual care, enhanced with caregiver support (EUC), for increasing MPA in 100 community dwelling adults with ADRD and their caregiver. The primary aim is to compare MPA (min/wk.), assessed by accelerometer, across the 6-mo. active intervention in adults with ADRD randomized to RGV or EUC. Secondarily, we will compare adults with ADRD and their caregivers randomized to RGV or ECU on the following outcomes across 18 mos.: MPA (min/wk.), sedentary time (min/wk.), percentage meeting 150 min/wk. MPA goal, functional fitness, activities of daily living, quality of life, residential transitions, cognitive function, and caregiver burden. Additionally, we will evaluate the influence of age, sex, BMI, attendance (exercise/support sessions), use of recorded sessions, self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers on changes in MPA in adults with ADRD and their caregiver across 18 mos.",2020,"A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group.","['community dwelling adults with ADRD and their caregivers', ""Adults with Alzheimer's disease and related dementia (ADRD) and their caregivers represent a sizeable and underserved segment of the population with low levels of moderate physical activity (MPA"", 'adults with ADRD randomized to', ""adults with Alzheimer's disease and their caregivers"", '100 community dwelling adults with ADRD and their caregiver', 'adults with ADRD and their caregivers randomized to', 'adults with ADRD and their caregivers (RGV', 'adults with ADRD and their caregiver across 18 mos']","['remote physical activity intervention', 'RGV or EUC', 'RGV approach with usual care, enhanced with caregiver support (EUC', 'RGV or ECU']","['MPA goal, functional fitness, activities of daily living, quality of life, residential transitions, cognitive function, and caregiver burden']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",100.0,0.092155,"A home-based physical activity intervention delivered remotely via video conferencing to groups of adults with ADRD and their caregivers (RGV), represents a potentially effective approach for increasing MPA in this group.","[{'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: lptomey@kumc.edu.'}, {'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Szabo-Reed', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: aszabo@kumc.edu.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: evidoni@kumc.edu.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: agorczyca@ku.edu.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Little', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: todd.d.little@ttu.edu.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Educational Psychology and Leadership, Texas Tech University, 2500 Broadway, Lubbock, TX 79409, USA. Electronic address: jaehoon.lee@ttu.edu.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Helsel', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: bhelsel@kumc.edu.'}, {'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'School of Nursing, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: kwilliams1@kumc.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106158']
3126,32979521,Neural correlates of future weight loss reveal a possible role for brain-gastric interactions.,"Lifestyle dietary interventions are an essential practice in treating obesity, hence neural factors that may assist in predicting individual treatment success are of great significance. Here, in a prospective, open-label, three arms study, we examined the correlation between brain resting-state functional connectivity measured at baseline and weight loss following 6 months of lifestyle intervention in 92 overweight participants. We report a robust subnetwork composed mainly of sensory and motor cortical regions, whose edges correlated with future weight loss. This effect was found regardless of intervention group. Importantly, this main finding was further corroborated using a stringent connectivity-based prediction model assessed with cross-validation thus attesting to its robustness. The engagement of senso-motor regions in this subnetwork is consistent with the over-sensitivity to food cues theory of weight regulation. Finally, we tested an additional hypothesis regarding the role of brain-gastric interaction in this subnetwork, considering recent findings of a cortical network synchronized with gastric activity. Accordingly, we found a significant spatial overlap with the subnetwork reported in the present study. Moreover, power in the gastric basal electric frequency within our reported subnetwork negatively correlated with future weight loss. This finding was specific to the weight loss related subnetwork and to the gastric basal frequency. These findings should be further corroborated by combining direct recordings of gastric activity in future studies. Taken together, these intriguing results may have important implications for our understanding of the etiology of obesity and the mechanism of response to dietary intervention.",2020,This effect was found regardless of intervention group.,['92 overweight participants'],['Lifestyle dietary interventions'],['brain resting-state functional connectivity'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",92.0,0.0170556,This effect was found regardless of intervention group.,"[{'ForeName': 'Gidon', 'Initials': 'G', 'LastName': 'Levakov', 'Affiliation': 'Department of Brain and Cognitive Sciences; Zlotowski Center for Neuroscience. Electronic address: gidonle@post.bgu.ac.il.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Anat Yaskolka', 'Initials': 'AY', 'LastName': 'Meir', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Rinott', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Tsaban', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Zelicha', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Nachshon', 'Initials': 'N', 'LastName': 'Meiran', 'Affiliation': 'Zlotowski Center for Neuroscience; Department of Psychology.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Shelef', 'Affiliation': 'Zlotowski Center for Neuroscience; Department of Diagnostic Imaging; Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Galia', 'Initials': 'G', 'LastName': 'Avidan', 'Affiliation': 'Department of Brain and Cognitive Sciences; Zlotowski Center for Neuroscience; Department of Psychology.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117403']
3127,32979577,"Cerebrospinal fluid biomarkers of brain injury, inflammation and synaptic autoimmunity predict long-term neurocognitive outcome in herpes simplex encephalitis.","OBJECTIVES


To investigate the correlation between biomarkers of brain injury and long-term neurocognitive outcome, and the interplay with intrathecal inflammation and neuronal autoimmunity, in patients with herpes simplex encephalitis (HSE).
METHODS


A total of 53 adult/adolescent HSE patients were included from a prospective cohort in a randomized placebo-controlled trial investigating the effect of a 3-month follow-up treatment with valaciclovir. Study subjects underwent repeated serum/CSF sampling and brain MRI the first 3 months along with cognitive assessment by Mattis Dementia Rating Scale (MDRS) during 24 months. CSF samples were analyzed for biomarkers of brain injury, inflammation and synaptic autoimmunity. The pre-defined primary analysis was the correlation between peak CSF neurofilament protein (NFL), a biomarker of neuronal damage, and MDRS at 24 months.
RESULTS


Impaired cognitive performance significantly correlated with NFL levels (rho = -0.36, p = 0.020). Development of IgG anti-N-methyl-D-aspartate receptor (NDMAR) antibodies was associated with a broad and prolonged proinflammatory CSF response. In a linear regression model, lower MDRS at 24 months was associated with previous development of IgG anti-NMDAR (beta = -0.6249, p = 0.024) and age (z-score beta = -0.2784, p = 0.024), but not CSF NFL, which however significantly correlated with subsequent NMDAR autoimmunization (p = 0.006).
CONCLUSIONS


Our findings show that NFL levels are predictive of long-term neurocognitive outcome in HSE, and suggest a causative chain of events where brain tissue damage increases the risk of NMDAR autoimmunisation and subsequent prolongation of CSF inflammation. The data provides guidance for a future intervention study of immunosuppressive therapy administered in the recovery phase of HSE.",2020,"RESULTS


Impaired cognitive performance significantly correlated with NFL levels (rho = -0.36, p = 0.020).","['patients with herpes simplex encephalitis (HSE', 'herpes simplex encephalitis', 'A total of 53 adult/adolescent HSE patients']","['placebo', 'immunosuppressive therapy', 'IgG anti-N-methyl-D-aspartate receptor (NDMAR) antibodies', 'valaciclovir']","['NFL levels', 'peak CSF neurofilament protein (NFL), a biomarker of neuronal damage, and MDRS', 'subsequent NMDAR autoimmunization', 'Mattis Dementia Rating Scale (MDRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0014038', 'cui_str': 'Encephalitis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0051979', 'cui_str': 'Anti-Immunoglobulin G antibody'}, {'cui': 'C2919931', 'cui_str': 'N-methyl-D-aspartate receptor antibody'}, {'cui': 'C0249458', 'cui_str': 'valacyclovir'}]","[{'cui': 'C0085418', 'cui_str': 'Neurofilament protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}]",53.0,0.106535,"RESULTS


Impaired cognitive performance significantly correlated with NFL levels (rho = -0.36, p = 0.020).","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Westman', 'Affiliation': 'Department of Medical Sciences, Section of Infectious Diseases, Uppsala University, Uppsala, Sweden. Electronic address: gabriel.westman@medsci.uu.se.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Aurelius', 'Affiliation': 'Unit of Infectious Diseases, Department of Medicine, Karolinska Institutet, and Department of Infectious Diseases, Karolinska University Hospital, Solna, Sweden.'}, {'ForeName': 'Clas', 'Initials': 'C', 'LastName': 'Ahlm', 'Affiliation': 'Department of Clinical Microbiology, Infection and Immunology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Eriksson', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Lind', 'Affiliation': 'Department of Rheumatology and Inflammation Research, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Schliamser', 'Affiliation': 'Department of Clinical Sciences, Division of Infection Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Sund', 'Affiliation': 'Department of Medical Sciences, Section of Infectious Diseases, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden; Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden; Department of Neurodegenerative Disease, UCL Institute of Neurology, London, United Kingdom; UK Dementia Research Institute at UCL, London, United Kingdom.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Studahl', 'Affiliation': 'Institute of Biomedicine, The Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden; Department of Infectious Diseases, Sahlgrenska University Hospital, Gothenburg, Sweden8.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.09.031']
3128,32979620,"Prophylactic use of tranexamic acid for prevention of bleeding during transbronchial lung biopsies - A randomized, double-blind, placebo-controlled trial.","BACKGROUND


Although massive bleeding following transbronchial lung biopsies (TBLB) is rare, even minor hemorrhage may prolong the procedure and result in inadequate sampling. Tranexamic acid (TXA) is an antifibrinolytic agent, which reduces bleeding in numerous scenarios, however, its prophylactic use in mitigating post-TBLB bleeding has not been investigated. We conducted a prospective, randomized, double-blind, placebo-controlled trial to determine whether topical infusion of TXA prior to TBLB would reduce bleeding, shorten procedure duration and increase the number of biopsies obtained.
METHODS


We blindly randomized patients undergoing TBLB to receive topical TXA or placebo in the lobar bronchus prior to biopsies. Vital signs, procedure length, fluid balance (as a measure of the amount of bleeding), operator's assessment of bleeding, and number of biopsies obtained were measured. Data was analyzed using the two-tailed Student's T-Test, Chi-square or Mann-Whitney tests as appropriate.
RESULTS


Fifty patients were randomized, 26 to the TXA arm. The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90). There were no clinically significant adverse events in any of the groups up to one month of follow up.
CONCLUSION


Endobronchial installation of TXA prior to obtaining TBLB results in less bleeding and allows more biopsies to be obtained with no additional adverse events. The prophylactic use of TXA during TBLB may be considered as standard.",2020,"The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90).","['We blindly randomized patients undergoing TBLB to receive', 'Fifty patients were randomized, 26 to the TXA arm']","['Tranexamic acid (TXA', 'topical TXA or placebo', 'tranexamic acid', 'placebo', 'TXA']","['number of biopsies obtained', 'adverse events', 'procedure length', ""Vital signs, procedure length, fluid balance (as a measure of the amount of bleeding), operator's assessment of bleeding, and number of biopsies obtained"", 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0863477', 'cui_str': 'Transbronchial lung biopsy'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449807', 'cui_str': 'Number of biopsies'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",50.0,0.616386,"The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90).","[{'ForeName': 'Rottem', 'Initials': 'R', 'LastName': 'Kuint', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. Electronic address: kuint@hadassah.org.il.'}, {'ForeName': 'Liran', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'Institute of Pulmonary Medicine, Chaim Sheba Medical Center, The Sackler School of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'Cohen Goichman', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Huszti', 'Affiliation': 'Biostatistics Research Unit, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abu Rmeileh', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ora', 'Initials': 'O', 'LastName': 'Shriki', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Abutbul', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Zvi G', 'Initials': 'ZG', 'LastName': 'Fridlender', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Berkman', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106162']
3129,32979635,Endothelial shear stress and vascular remodeling in bioresorbable scaffold and metallic stent.,"BACKGROUND AND AIMS


The impact of endothelial shear stress (ESS) on vessel remodeling in vessels implanted with bioresorbable scaffold (BRS) as compared to metallic drug-eluting stent (DES) remains elusive. The aim of this study was to determine whether the relationship between ESS and remodeling patterns differs in BRS from those seen in metallic DES at 3-year follow-up.
METHODS


In the ABSORB II randomized trial, lesions were investigated by serial coronary angiography and intravascular ultrasound (IVUS). Three-dimensional reconstructions of coronary arteries post-procedure and at 3 years were performed. ESS was quantified using non-Newtonian steady flow simulation. IVUS cross-sections in device segment were matched using identical landmarks.
RESULTS


Paired ESS calculations post-procedure and at 3 years were feasible in 57 lesions in 56 patients. Post-procedure, median ESS at frame level was higher in BRS than in DES, with marginal statistical significance (0.97 ± 0.48 vs. 0.75 ± 0.39 Pa, p = 0.063). In the BRS arm, vessel area and lumen area showed larger increases in the highest tercile of median ESS post-procedure as compared to the lowest tercile. In contrast, in DES, no significant relationship between median ESS post-procedure and remodeling was observed. In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames. Only in BRS, younger age was an additional significant predictor of expansive remodeling.
CONCLUSIONS


In a subset of lesions with large plaque burden, shear stress could be associated with expansive remodeling and late lumen enlargement in BRS, while ESS had no impact on vessel dimension in metallic DES.",2020,"In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames.",[],"['bioresorbable scaffold (BRS', 'endothelial shear stress (ESS']",['Endothelial shear stress and vascular remodeling'],[],"[{'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3850148', 'cui_str': 'Vascular Remodeling'}]",,0.0802054,"In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames.","[{'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Tenekecioglu', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Katagiri', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Department of Interventional Cardiology, Jagiellonian University, Krakow, Poland.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': 'Bellvitge University Ho^spital, Barcelona, Spain.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': 'Hopital de Rangueil, Toulouse, France.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez', 'Affiliation': 'Interventional Cardiology Unit, Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Rinse', 'Initials': 'R', 'LastName': 'Johannes van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Dominici', 'Affiliation': 'S Maria University Hospital, Terni, Italy.'}, {'ForeName': 'Ad J van', 'Initials': 'AJV', 'LastName': 'Boven', 'Affiliation': 'Medical Center Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': 'Biomédiques August Pi I Sunyer, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Bristol Heart Institute, Bristol, United Kingdom.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': 'Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Kitslaar', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Jouke', 'Initials': 'J', 'LastName': 'Dijkstra', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Johan H C', 'Initials': 'JHC', 'LastName': 'Reiber', 'Affiliation': 'LKEB-Division of Image Processing, Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': 'Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Ural', 'Affiliation': 'Department of Cardiology, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Kerem', 'Initials': 'K', 'LastName': 'Pekkan', 'Affiliation': 'Department of Mechanical Engineering, Koç University, Istanbul, Turkey.'}, {'ForeName': 'Christos V', 'Initials': 'CV', 'LastName': 'Bourantas', 'Affiliation': 'Department of Cardiology, University College of London Hospitals, London, United Kingdom; Department of Cardiology, Barts Heart Centre, London, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Gijsen', 'Affiliation': 'Department of Biomedical Engineering, Erasmus University Medical Center, Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center. Thoraxcenter, Rotterdam, the Netherlands.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Torii', 'Affiliation': 'Department of Mechanical Engineering, University College London, United Kingdom.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College London, London, United Kingdom; Department of cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.08.031']
3130,31214935,Application of System Dynamics to Inform a Model of Adolescent SBIRT Implementation in Primary Care Settings.,"System dynamics (SD) modeling is used to compare and contrast strategies for effective implementation of an evidence-based adolescent behavioral health treatment in primary care settings. With qualitative and quantitative data from an on-going cluster-randomized trial in 7 federally qualified health center sites, two implementation conditions were compared: generalist vs. specialist. In the generalist approach, the primary care provider (PCP) delivered brief intervention (BI) for substance misuse (n = 4 clinics). In the specialist approach, BIs were delivered by behavioral health counselors (BHCs) (n = 3 clinics). The resultant SD model compared 'basecase' dynamics to strategic approaches to deploying continuous technical assistance (TA) and performance feedback reporting (PFR). The basecase effectively represented the SBIRT intervention, which reflected actual monthly volume of adolescent primary care visits (N = 9639), screenings (N = 5937), positive screenings (N = 246), and brief interventions (BIs; N = 50) over the 20-month implementation period. Insights gained suggest that implementation outcomes are sensitive to frequency of PFR, with bimonthly events generating the most rapid and sustained screening results. Simulated trends indicated that availability of the BHC directly impacts success of the specialist model. Similarly, understanding PCPs' perception of severity of need for intervention is key to outcomes in either condition.",2020,The resultant SD model compared 'basecase' dynamics to strategic approaches to deploying continuous technical assistance (TA) and performance feedback reporting (PFR).,[],[],[],[],[],[],7.0,0.0147494,The resultant SD model compared 'basecase' dynamics to strategic approaches to deploying continuous technical assistance (TA) and performance feedback reporting (PFR).,"[{'ForeName': 'David William', 'Initials': 'DW', 'LastName': 'Lounsbury', 'Affiliation': 'Montefiore Medical Center, Division of Community Collaboration and Implementation Science, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY, 10461, USA. David.Lounsbury@einstein.yu.edu.'}, {'ForeName': 'Shannon Gwin', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Kristi Ann', 'Initials': 'KA', 'LastName': 'Dusek', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Josh Zhi', 'Initials': 'JZ', 'LastName': 'Li', 'Affiliation': 'College of Global Public Health, New York University, New York, NY, USA.'}, {'ForeName': 'Arethusa S', 'Initials': 'AS', 'LastName': 'Kirk', 'Affiliation': 'Total Health Care, Baltimore, MD, USA.'}, {'ForeName': 'Marla', 'Initials': 'M', 'LastName': 'Oros', 'Affiliation': 'The Mosaic Group, Baltimore, MD, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Hosler', 'Affiliation': 'University of Maryland Baltimore County, Baltimore, MD, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Monico', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Brown', 'Affiliation': 'Friends Research Institute, Baltimore, MD, USA.'}]",The journal of behavioral health services & research,['10.1007/s11414-019-09650-y']
3131,28268311,Behavioral informatics: Dynamical models for measuring and assessing behaviors for precision interventions.,"Poor health-related behaviors represent a major challenge to healthcare due to their significant impact on chronic and acute diseases and their effect on the quality of life. Recent advances in technology have enabled an unprecedented opportunity to assess objectively, unobtrusively and continuously human behavior and have opened the possibility of optimizing individual-tailored, precision interventions within the framework of behavioral informatics. A key prerequisite for this optimization is the ability to assess and predict effects of interventions. This is potentially achievable with computational models of behavior and behavior change. In this paper we describe various approaches to computational modeling and describe a new hybrid model based on a dual process theoretical framework for behavior change. The model leverages cognitive learning theories and is shown to be consistent with mobile intervention data. We also illustrate how system-theoretic approaches can be used to assess the effect of coaching and participants' health behaviors.",2016,We also illustrate how system-theoretic approaches can be used to assess the effect of coaching and participants' health behaviors.,[],[],['quality of life'],[],[],[{'cui': 'C0034380'}],,0.0218329,We also illustrate how system-theoretic approaches can be used to assess the effect of coaching and participants' health behaviors.,"[{'ForeName': 'Misha', 'Initials': 'M', 'LastName': 'Pavel', 'Affiliation': ''}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Jimison', 'Affiliation': ''}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2016.7590672']
3132,6781794,"Hormone profile of T3, T4 at the end of pregnancy and during puerperium.","The Authors have studied the T3, T4 and TBG behaviour at the end of pregnancy and after 96 h and 144 h from delivery in 25 pregnant women. The patients have been randomly divided into two groups: the first was studied in basal conditions and the second after administration of enantate testosterone and valerianate estradiol. In the first group T3 and T4 values increased slightly. A higher increase was noticed from the 96th to the 144th h from delivery. In the second group T3 and T4 values were discording.",1980,In the first group T3 and T4 values increased slightly.,['25 pregnant women'],['enantate testosterone and valerianate estradiol'],[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}]",[],25.0,0.0186949,In the first group T3 and T4 values increased slightly.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Reitano', 'Affiliation': ''}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vecchio', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Boemi', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
3133,31980993,The Power of the Shared Experience: MTN-020/ASPIRE Trial Participants' Descriptions of Peer Influence on Acceptability of and Adherence to the Dapivirine Vaginal Ring for HIV Prevention.,"Women are disproportionately at risk of acquiring HIV in East and Southern Africa, despite global declines in incidence. Female-initiated HIV prevention methods, like the dapivirine vaginal ring, are needed to end the HIV epidemic. In-depth interviews and focus groups retrospectively explored peer influence on acceptability of and adherence to the ring during the ASPIRE trial, a phase III placebo-controlled trial. Results were analyzed using an inductive analytic approach. Study participants (peers) of all ages and adherence groups developed important interpersonal connections and reported being more open and honest with each other than with external peers or study staff. Study peers who knew each other prior to joining appeared to have a stronger influence on each other's adherence than peers who met in the study. External peers provided primarily negative input about the ring and study, which sometimes led to ring removals. Peers' influence on each other's behavior in both prosocial and detrimental manners could have repercussions on adherence to a biomedical intervention, and consequently, individual disease risk and clinical trial outcomes. Future ring demonstration and implementation studies could use peer networks to intentionally influence uptake and adherence to the ring.",2020,Study peers who knew each other prior to joining appeared to have a stronger influence on each other's adherence than peers who met in the study.,['Study participants (peers) of all ages and adherence groups developed important interpersonal connections and reported being more open and honest with each other than with external peers or study staff'],[],[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]",[],[],,0.0378847,Study peers who knew each other prior to joining appeared to have a stronger influence on each other's adherence than peers who met in the study.,"[{'ForeName': 'Ariana W K', 'Initials': 'AWK', 'LastName': 'Katz', 'Affiliation': ""Women's Global Health Imperative, RTI International, 351 California St, Suite 500, San Francisco, CA, 94104, USA. awkatz@rti.org.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reddy', 'Affiliation': 'Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chitukuta', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nabukeera', 'Affiliation': 'Makerere University-Johns Hopkins University Research Unit, Kampala, Uganda.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Siva', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Zimba', 'Affiliation': 'University of North Carolina (UNC) Project-Lilongwe, Tidziwe Center, P/Bag A104, Lilongwe, Malawi.'}, {'ForeName': 'E T', 'Initials': 'ET', 'LastName': 'Montgomery', 'Affiliation': ""Women's Global Health Imperative, RTI International, 351 California St, Suite 500, San Francisco, CA, 94104, USA.""}]",AIDS and behavior,['10.1007/s10461-020-02799-0']
3134,31724959,His bundle pacing: conduction system capture and clinical impact.,"PURPOSE OF REVIEW


It has been nearly 2 decades since His bundle pacing (HBP) was described and with very first randomized pilot study published, reviewing its impact on clinical practice is inevitable.
RECENT FINDINGS


Inclusion of HBP in the guidelines, along with long-term outcomes, outcomes comparing selective and non selective HBP and investigator initiated randomized pilot comparing with cardiac resynchronization therapy, HBP has established itself as a feasible pacing alternative.
SUMMARY


HBP is an addition to the current armada of resynchronization techniques. HBP is an emerging area of interest, and is particularly relevant in patients, who require chronic ventricular pacing, but the long-term outcomes of this approach in large patient populations with low ejection fraction are still lacking. With several ongoing studies, in the near future we will have good-quality evidence to support native conduction system pacing as a viable alternative to improve meaningful outcomes.",2020,"RECENT FINDINGS


Inclusion of HBP in the guidelines, along with long-term outcomes, outcomes comparing selective and non selective HBP and investigator initiated randomized pilot comparing with cardiac resynchronization therapy, HBP has established itself as a feasible pacing alternative.
",[],[],[],[],[],[],,0.0308583,"RECENT FINDINGS


Inclusion of HBP in the guidelines, along with long-term outcomes, outcomes comparing selective and non selective HBP and investigator initiated randomized pilot comparing with cardiac resynchronization therapy, HBP has established itself as a feasible pacing alternative.
","[{'ForeName': 'Vatsal', 'Initials': 'V', 'LastName': 'Ladia', 'Affiliation': 'Department of Cardiovascular Disease, Division of Cardiac Electrophysiology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Komandoor', 'Initials': 'K', 'LastName': 'Srivathsan', 'Affiliation': 'Department of Cardiovascular Disease, Division of Cardiac Electrophysiology, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Mulpuru', 'Affiliation': 'Department of Cardiovascular Disease, Division of Cardiac Electrophysiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Win-Kuang', 'Initials': 'WK', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiovascular Disease, Division of Cardiac Electrophysiology, Mayo Clinic, Phoenix, Arizona.'}]",Current opinion in cardiology,['10.1097/HCO.0000000000000701']
3135,31758177,Live Respiratory Syncytial Virus Attenuated by M2-2 Deletion and Stabilized Temperature Sensitivity Mutation 1030s Is a Promising Vaccine Candidate in Children.,"BACKGROUND


The safety and immunogenicity of live respiratory syncytial virus (RSV) candidate vaccine, LID/ΔM2-2/1030s, with deletion of RSV ribonucleic acid synthesis regulatory protein M2-2 and genetically stabilized temperature-sensitivity mutation 1030s in the RSV polymerase protein was evaluated in RSV-seronegative children.
METHODS


Respiratory syncytial virus-seronegative children ages 6-24 months received 1 intranasal dose of 105 plaque-forming units (PFU) of LID/ΔM2-2/1030s (n = 21) or placebo (n = 11). The RSV serum antibodies, vaccine shedding, and reactogenicity were assessed. During the following RSV season, medically attended acute respiratory illness (MAARI) and pre- and postsurveillance serum antibody titers were monitored.
RESULTS


Eighty-five percent of vaccinees shed LID/ΔM2-2/1030s vaccine (median peak nasal wash titers: 3.1 log10 PFU/mL by immunoplaque assay; 5.1 log10 copies/mL by reverse-transcription quantitative polymerase chain reaction) and had ≥4-fold rise in serum-neutralizing antibodies. Respiratory symptoms and fever were common (60% vaccinees and 27% placebo recipients). One vaccinee had grade 2 wheezing with rhinovirus but without concurrent LID/ΔM2-2/1030s shedding. Five of 19 vaccinees had ≥4-fold increases in antibody titers postsurveillance without RSV-MAARI, indicating anamnestic responses without significant illness after infection with community-acquired RSV.
CONCLUSIONS


LID/ΔM2-2/1030s had excellent infectivity without evidence of genetic instability, induced durable immunity, and primed for anamnestic antibody responses, making it an attractive candidate for further evaluation.",2020,"Five of 19 vaccinees had >4-fold increases in antibody titers post-surveillance without RSV-MAARI, indicating anamnestic responses without significant illness following infection with community-acquired RSV.
","['children', 'RSV-seronegative children ages 6-24 months received one']",['intranasal dose of 105 plaque forming units (PFU) of LID/ΔM2-2/1030s (n=21) or placebo'],"['Respiratory symptoms and fever', 'medically-attended acute respiratory illness (MAARI) and pre- and post-surveillance serum antibody', 'grade 2 wheezing with rhinovirus', 'antibody titers', 'RSV serum antibodies, vaccine shedding, and reactogenicity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0035473', 'cui_str': 'Rhinovirus'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]",,,"Five of 19 vaccinees had >4-fold increases in antibody titers post-surveillance without RSV-MAARI, indicating anamnestic responses without significant illness following infection with community-acquired RSV.
","[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'McFarland', 'Affiliation': ""Department of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Karron', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Petronella', 'Initials': 'P', 'LastName': 'Muresan', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health/Frontier Science, Boston, Massachusetts, USA.'}, {'ForeName': 'Coleen K', 'Initials': 'CK', 'LastName': 'Cunningham', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Libous', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Perlowski', 'Affiliation': 'FHI 360, Durham, North Carolina, USA.'}, {'ForeName': 'Bhagvanji', 'Initials': 'B', 'LastName': 'Thumar', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Devasena', 'Initials': 'D', 'LastName': 'Gnanashanmugam', 'Affiliation': 'Maternal, Adolescent and Pediatric Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moye', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schappell', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Barr', 'Affiliation': ""Department of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Rexroad', 'Affiliation': 'Investigational Drug Service Pharmacy, Johns Hopkins Hospital, Baltimore, Maryland, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fearn', 'Affiliation': ""Department of Pediatrics, Northwestern University Medical School and Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Spector', 'Affiliation': 'Department of Pediatrics, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Aziz', 'Affiliation': 'Section of Infectious Disease, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Mikhaela', 'Initials': 'M', 'LastName': 'Cielo', 'Affiliation': 'Division of Infectious Diseases, Maternal Child and Adolescent Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Beneri', 'Affiliation': 'Department of Pediatrics, SUNY Stony Brook, Stony Brook, New York, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wiznia', 'Affiliation': 'Department of Pediatrics, Albert Einstein College of Medicine and Jacobi Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Luongo', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Collins', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Ursula J', 'Initials': 'UJ', 'LastName': 'Buchholz', 'Affiliation': 'Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz603']
3136,31863962,Burn injury and restoration of muscle function.,"Burn injury in children results in a systemic inflammatory reaction as well as a stress response. Consequences of these non-specific adaptive responses include resorptive bone loss and muscle catabolism. These adverse events can result in a post-burn fracture rate of approximately 15% and long-term muscle weakness that prolongs recovery. A randomized controlled trial of a single dose of the bisphosphonate pamidronate within the first ten days of burn injury resulted in the prevention of resorptive bone loss and continuous bone accrual. Examining the muscle protein kinetics in pediatric burn patients enrolled in that randomized controlled trial revealed that those who had been given the single dose bisphosphonate experienced preservation of muscle mass and strength. An in vitro study of mouse myoblasts incubated with serum from patients who participated in the randomized controlled study demonstrated that mouse myoblasts exposed to serum from patients given the single dose bisphosphonate exhibited greater myotube diameter than those from burned children given placebo. Moreover, the serum from bisphosphonate treated patients stimulated the protein anabolic pathways and suppressed protein catabolic pathways in these cells. Inasmuch as incubation of the myotubes with an antibody to transforming growth factor beta (TGFβ) rescued myotube size in the cultures with serum from patients who received the placebo to the same magnitude as cultures with serum from patients treated with single dose bisphosphonate, we postulate that post-burn bone resorption liberates muscle catabolic factors which cause muscle wasting. Future uses of bisphosphonates could include studies designed to prevent short-term acute bone resorption in conditions that may result in muscle wasting as well as in short-term interventions in chronic inflammatory conditions which may flare and cause acute bone and muscle loss.",2020,"Inasmuch as incubation of the myotubes with an antibody to transforming growth factor beta (TGFβ) rescued myotube size in the cultures with serum from patients who received the placebo to the same magnitude as cultures with serum from patients treated with single dose bisphosphonate, we postulate that post-burn bone resorption liberates muscle catabolic factors which cause muscle wasting.",['pediatric burn patients enrolled'],"['placebo', 'bisphosphonate pamidronate', 'bisphosphonate', 'bisphosphonates']","['muscle mass and strength', 'resorptive bone loss and continuous bone accrual']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C0043603', 'cui_str': 'pamidronate'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]",,0.0785012,"Inasmuch as incubation of the myotubes with an antibody to transforming growth factor beta (TGFβ) rescued myotube size in the cultures with serum from patients who received the placebo to the same magnitude as cultures with serum from patients treated with single dose bisphosphonate, we postulate that post-burn bone resorption liberates muscle catabolic factors which cause muscle wasting.","[{'ForeName': 'Gordon L', 'Initials': 'GL', 'LastName': 'Klein', 'Affiliation': 'Department of Orthopaedic Surgery and Rehabilitation, University of Texas Medical Branch, Galveston, TX 77555-0165, USA. Electronic address: gordonklein@ymail.com.'}]",Bone,['10.1016/j.bone.2019.115194']
3137,31553474,How and when informative visit processes can bias inference when using electronic health records data for clinical research.,"OBJECTIVE


Electronic health records (EHR) data have become a central data source for clinical research. One concern for using EHR data is that the process through which individuals engage with the health system, and find themselves within EHR data, can be informative. We have termed this process informed presence. In this study we use simulation and real data to assess how the informed presence can impact inference.
MATERIALS AND METHODS


We first simulated a visit process where a series of biomarkers were observed informatively and uninformatively over time. We further compared inference derived from a randomized control trial (ie, uninformative visits) and EHR data (ie, potentially informative visits).
RESULTS


We find that only when there is both a strong association between the biomarker and the outcome as well as the biomarker and the visit process is there bias. Moreover, once there are some uninformative visits this bias is mitigated. In the data example we find, that when the ""true"" associations are null, there is no observed bias.
DISCUSSION


These results suggest that an informative visit process can exaggerate an association but cannot induce one. Furthermore, careful study design can, mitigate the potential bias when some noninformative visits are included.
CONCLUSIONS


While there are legitimate concerns regarding biases that ""messy"" EHR data may induce, the conditions for such biases are extreme and can be accounted for.",2019,"We further compared inference derived from a randomized control trial (ie, uninformative visits) and EHR data (ie, potentially informative visits).
",[],[],[],[],[],[],,0.0404811,"We further compared inference derived from a randomized control trial (ie, uninformative visits) and EHR data (ie, potentially informative visits).
","[{'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Goldstein', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Phelan', 'Affiliation': 'Center for Predictive Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Neha J', 'Initials': 'NJ', 'LastName': 'Pagidipati', 'Affiliation': 'Center for Predictive Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Peskoe', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz148']
3138,18003182,Detection of synchronized firings in multivariate neural spike trains during motor tasks.,"This paper describes and compares two classical methods for the detection of neuron groups which exhibit synchronized firings in multivariate spike trains. These methods were compared on experimental and randomized data corresponding to the firing activity of 104 neurons located in motor, premotor, and parietal cortices in a monkey during movement tasks. Both methods exhibited high false positive rates in randomized data, but results showed that this rate can be advantageously reduced with a simple postprocessing. Otherwise, one method permitted to detect a significant number of synchronized groups of neurons related to the behavioral task.",2007,This paper describes and compares two classical methods for the detection of neuron groups which exhibit synchronized firings in multivariate spike trains.,[],[],[],[],[],[],104.0,0.0382822,This paper describes and compares two classical methods for the detection of neuron groups which exhibit synchronized firings in multivariate spike trains.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bourien', 'Affiliation': 'CREFA-Université Montpellier 1, 15 avenue Charles Flahault, Montpellier Cedex 5, France. jerome.bourien@univ-montp1.fr'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Sanchez', 'Affiliation': ''}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Bellanger', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Wendling', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Principe', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,[]
3139,2713990,Changes in the Bishop score induced by manual nipple stimulation. A cross-over randomized study.,"Bishop score changes, by a cross-over, randomized study, were evaluated in 60 primigravidas at term, not yet in labour, who performed nipple stimulation for 45 minutes three times a day for three days. Results showed that changes of Bishop score in the treated groups were statistically highly significant, in comparison to control groups. A greater frequency in the onset of labour was also remarked.",1989,"Results showed that changes of Bishop score in the treated groups were statistically highly significant, in comparison to control groups.",[],[],['changes of Bishop score'],[],[],"[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}]",,0.0421258,"Results showed that changes of Bishop score in the treated groups were statistically highly significant, in comparison to control groups.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Lieto', 'Affiliation': 'II Facoltà di Medicina e Chirurgia, Università degli Studi di Napoli.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Miranda', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ardito', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Favale', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Albano', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
3140,32205478,Keeping pace with the competition: His bundle versus biventricular pacing in heart failure.,"PURPOSE OF REVIEW


His bundle pacing (HBP) has emerged as a novel method to achieve electrical resynchronization in bundle branch block and as an alternative means to deliver cardiac resynchronization therapy (CRT). There are now data on HBP in CRT-eligible patients from cohort studies and a single pilot randomized controlled trial (RCT).
RECENT FINDINGS


Early clinical data regarding HBP in heart failure have demonstrated echocardiographic and functional improvement similar to traditional biventricular pacing (BiV), mostly when utilized as a bailout to traditional BiV-CRT. A single pilot RCT, His-SYNC, showed a trend toward greater echocardiographic response in an on-treatment analysis, but was underpowered. No large RCTs have reported long-term clinical outcomes. In order to realize any benefit from HBP, output-dependent morphology changes must be demonstrated to ensure the conduction system capture is present. There may be a role for corrective HBP in patients with right bundle branch block and after atrioventricular node ablation, which is theoretically more desirable than traditional BiV. Importantly, however, HBP is likely not to benefit patients with nonspecific intraventricular conduction delay.
SUMMARY


HBP is emerging as an alternative strategy for CRT and may have a role in patients in whom traditional BiV is not achievable or ineffective.",2020,"There may be a role for corrective HBP in patients with right bundle branch block and after atrioventricular node ablation, which is theoretically more desirable than traditional BiV.",['heart failure'],[],['echocardiographic response'],"[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",[],[],,0.0503162,"There may be a role for corrective HBP in patients with right bundle branch block and after atrioventricular node ablation, which is theoretically more desirable than traditional BiV.","[{'ForeName': 'Gaurav A', 'Initials': 'GA', 'LastName': 'Upadhyay', 'Affiliation': 'University of Chicago Medicine, Center for Arrhythmia Care | Heart and Vascular Center, Chicago, Illinois, USA.'}, {'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'Tung', 'Affiliation': ''}]",Current opinion in cardiology,['10.1097/HCO.0000000000000735']
3141,19164006,The effect of GSM-like ELF radiation on the alpha band of the human resting EEG.,"Mobile phone handsets such as those operating in the GSM network emit extremely low frequency electromagnetic fields ranging from DC to at least 40 kHz. As a subpart of an extended protocol, the influence of these fields on the human resting EEG has been investigated in a fully counter balanced, double blind, cross-over design study that recruited 72 healthy volunteers. A decrease in the alpha frequency band was observed during the 20 minutes of ELF exposure in the exposed hemisphere only. This result suggests that ELF fields as emitted from GSM handsets during the DTX mode may have an effect on the resting alpha band of the human EEG.",2008,A decrease in the alpha frequency band was observed during the 20 minutes of ELF exposure in the exposed hemisphere only.,['72 healthy volunteers'],['GSM-like ELF radiation'],[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0069228', 'cui_str': 'O-(glucuronic acid 2-sulfate)-(1--4)-O-(2,5)-anhydromannitol 6-sulfate'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]",[],72.0,0.0519688,A decrease in the alpha frequency band was observed during the 20 minutes of ELF exposure in the exposed hemisphere only.,"[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Perentos', 'Affiliation': 'RMIT University, Melbourne, VIC 3000, Australia. n.perentos@student.rmit.edu.au'}, {'ForeName': 'Rodney J', 'Initials': 'RJ', 'LastName': 'Croft', 'Affiliation': ''}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'McKenzie', 'Affiliation': ''}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Cvetkovic', 'Affiliation': ''}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Cosic', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2008.4650503']
3142,31445052,"Diurnal influences of fasted and non-fasted brisk walking on gastric emptying rate, metabolic responses, and appetite in healthy males.","Growing evidence suggests circadian rhythms, nutrition and metabolism are intimately linked. Intermittent fasting (IMF) has become an increasingly popular intervention for metabolic health and combining IMF with exercise may lead to benefits for weight management. However, little is known about the diurnal variation of fasted exercise. This study aimed to investigate the diurnal influences on gastric emptying rate (GER), metabolic responses, and appetite to fasted and non-fasted exercise. Twelve healthy males completed four 45 min walks in a randomised order. Walks were completed in the morning (AM) and evening (PM) and either fasted (FASTED) or after consumption of a standardised meal (FED). GER of a semi-solid lunch was subsequently measured for 2 h using the  13 C breath test. Blood glucose concentration, substrate utilisation, and ratings of appetite were measured throughout. Energy intake was also assessed for the following 24 h. GER T lag  was slower in PM-FASTED compared to AM-FASTED, AM-FED, and PM-FED (75 ± 18 min vs. 63 ± 14 min, P = 0.001, vs. 65 ± 10 min, P = 0.028 and vs. 67 ± 16 min, P = 0.007). Blood glucose concentration was greater in the FED trials in comparison to the FASTED trials pre-lunch (P < 0.05). Fat oxidation was greater throughout exercise in both FASTED trials compared to FED, and remained higher in FASTED trials than fed trials post-exercise until 30 min post-lunch ingestion (all P < 0.05). No differences were found for appetite post-lunch (P > 0.05) or 24 h post-energy intake (P = 0.476). These findings suggest that evening fasted exercise results in delayed GER, without changes in appetite. No compensatory effects were observed for appetite, and 24 h post-energy intake for both fasted exercise trials, therefore, increased fat oxidation holds positive implications for weight management.",2019,"Fat oxidation was greater throughout exercise in both FASTED trials compared to FED, and remained higher in FASTED trials than fed trials post-exercise until 30 min post-lunch ingestion (all P < 0.05).","['healthy males', 'Twelve healthy males']","['fasted and non-fasted brisk walking', 'Intermittent fasting (IMF']","['Blood glucose concentration, substrate utilisation, and ratings of appetite', 'appetite post-lunch', 'gastric emptying rate, metabolic responses, and appetite', 'Fat oxidation', 'GER T lag', 'gastric emptying rate (GER), metabolic responses, and appetite to fasted and non-fasted exercise', 'Energy intake', 'Blood glucose concentration']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0443162', 'cui_str': 'Brisk (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]","[{'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0230779', 'cui_str': 'Endoplasmic Reticulum, Granular'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",12.0,0.121153,"Fat oxidation was greater throughout exercise in both FASTED trials compared to FED, and remained higher in FASTED trials than fed trials post-exercise until 30 min post-lunch ingestion (all P < 0.05).","[{'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'McIver', 'Affiliation': 'Department of Life Sciences, Manchester Metropolitan University, UK.'}, {'ForeName': 'Lewis R', 'Initials': 'LR', 'LastName': 'Mattin', 'Affiliation': 'Department of Life Sciences, Manchester Metropolitan University, UK.'}, {'ForeName': 'Gethin H', 'Initials': 'GH', 'LastName': 'Evans', 'Affiliation': 'Department of Life Sciences, Manchester Metropolitan University, UK.'}, {'ForeName': 'Adora M W', 'Initials': 'AMW', 'LastName': 'Yau', 'Affiliation': 'Department of Life Sciences, Manchester Metropolitan University, UK. Electronic address: a.yau@mmu.ac.uk.'}]",Appetite,['10.1016/j.appet.2019.104411']
3143,30441506,Effects of Mapping Uncertainty on Visuomotor Adaptation to Trial-By-Trial Perturbations with Proportional Myoelectric Control.,"Myoelectric control based on classification of distinct gestures discretizes the output space available to the user, which can make it difficult to react appropriately to novel scenarios such as changing limb position. While proportional myoelectric control is noisy in comparison to pattern recognition control, this noise may be an important component of skill acquisition. Here we implemented a two-dimensional proportional myoelectric controller to investigate the effects of movement direction and mapping uncertainty on adaptation to trial-by-trial perturbations. We found that subjects who practiced hitting targets despite trial-by-trial random modifications of the control mapping adapted to perturbations faster than a control group with low mapping variability. Our findingssuggestthatexposuretoavariablemappingencourages exploratory behavior and underlies a change in adaption rate, which could potentially be used to train myoelectric control users to achieve more robust control.",2018,We found that subjects who practiced hitting targets despite trial-by-trial random modifications of the control mapping adapted to perturbations faster than a control group with low mapping variability.,[],[],[],[],[],[],,0.019084,We found that subjects who practiced hitting targets despite trial-by-trial random modifications of the control mapping adapted to perturbations faster than a control group with low mapping variability.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kenneth Lyons', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sanjay Joshi', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2018.8513412']
3144,31351965,"Efficacy and safety of intra-articular injection of tropomyosin receptor kinase A inhibitor in painful knee osteoarthritis: a randomized, double-blind and placebo-controlled study.","OBJECTIVE


This trial evaluated the efficacy and safety of GZ389988A, a tropomyosin receptor kinase A (TrkA) inhibitor, in subjects with painful knee osteoarthritis (OA).
METHOD


In this single center, double-blind, placebo-controlled and randomized trial, 104 subjects with moderate-to-severe knee OA pain were enrolled to receive a single intra-articular (IA) injection of either GZ389988A or placebo. Efficacy measures were assessed over 12 weeks and included walking pain (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] A1), overall knee pain, WOMAC A, B, C and total score, Patient Global Impression of Change (PGIC), OMERACT-OARSI responder rate and rescue medication use. Adverse events (AEs) were monitored up to 24 weeks.
RESULTS


The primary efficacy endpoint was met with a between-group difference of -7.49 (VAS 0-100) on WOMAC A1 changes over 4 weeks (P < 0.05 favoring GZ389988A). The secondary outcome on WOMAC A1 changes over 12 weeks had a between-group difference of -6.78 (P = 0.064). Among weekly assessments, statistically significant greater improvement in the GZ389988A group was observed in WOMAC A1, overall knee pain and/or WOMAC A at weeks 2-5. Although not statistically significant, improvements over placebo on pain and WOMAC C persisted over 12 weeks. Greater AE incidence was observed in the GZ389988A group including transient and self-limited injection joint inflammatory reactions with a spike of acetaminophen intake within the first week post-injection.
CONCLUSION


IA injection of TrkA inhibitor GZ389988A in knee OA subjects reduced pain with a numerically functional gain and an acceptable safety profile. (ClinicalTrials.gov, NCT02845271).",2019,(VAS 0-100) on WOMAC A1 changes over 4 weeks (P < 0.05 favoring GZ389988A).,"['104 subjects with moderate-to-severe knee OA pain', 'painful knee osteoarthritis', 'subjects with painful knee osteoarthritis (OA']","['intra-articular injection of tropomyosin receptor kinase A inhibitor', 'placebo', 'GZ389988A', 'single intra-articular (IA) injection of either GZ389988A or placebo', 'GZ389988A, a tropomyosin receptor kinase A (TrkA) inhibitor', 'TrkA inhibitor GZ389988A']","['Greater AE incidence', 'WOMAC A1 changes', 'walking pain (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] A1), overall knee pain, WOMAC A, B, C and total score, Patient Global Impression of Change (PGIC), OMERACT-OARSI responder rate and rescue medication use', 'pain and WOMAC C', 'WOMAC A1, overall knee pain', 'Efficacy and safety', 'Adverse events (AEs']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0021488', 'cui_str': 'Intra-Articular Injections'}, {'cui': 'C0041197', 'cui_str': 'Tropomyosin'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",104.0,0.391738,(VAS 0-100) on WOMAC A1 changes over 4 weeks (P < 0.05 favoring GZ389988A).,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Krupka', 'Affiliation': 'Sanofi R&D, 371, Rue du Professeur Joseph Blayac, 34184 Montpellier, France. Electronic address: emmanuel.krupka@sanofi.com.'}, {'ForeName': 'G-L', 'Initials': 'GL', 'LastName': 'Jiang', 'Affiliation': 'Sanofi R&D, 50 Binney Street, Cambridge, MA 02142, USA. Electronic address: LeonJiangMD@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jan', 'Affiliation': 'Sanofi R&D, 1 Avenue Pierre Brossolette, 91385 Chilly-Mazarin, France. Electronic address: christelle.jan@sanofi.com.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2019.05.028']
3145,32114905,A pragmatic approach to measuring adherence in treatment delivery in psychotherapy.,"Measuring therapists' adherence to treatment manuals is recommended for evaluating treatment integrity, yet ways to do this are poorly defined, time consuming, and costly. The aims of the study were to develop a Therapy Component Checklist (TCC) to measure adherence to manualised CBT; to test its application in research and clinical practice; to determine its validity; and consider its cost benefits. We conducted a randomised trial in 230 people with cancer evaluating effectiveness of CBT for depression. In this, therapists delivered manualised treatment.  Experts agreed on key components of therapy and therapists were asked to record these after therapy sessions by ticking a TCC. Inter-rater reliability was tested using an independent rater.  Therapists delivered 543 CBT sessions. TCCs were completed in 293, of which 39 were assessed by the independent rater. Self-reported TCC data suggested close adherence to the manual. Prevalence-adjusted and bias-adjusted kappa scores suggested substantial agreement, (>0.60) in 38 out of 46 items.  Self-rating of adherence saved around £96 per rating. In conclusion the TCC provides a quick and cost effective way of evaluating the components of therapy delivered. This approach could be applied to other psychological treatments and may help with linking therapeutic interventions with outcome.",2020,"Prevalence-adjusted and bias-adjusted kappa scores suggested substantial agreement, (>0.60) in 38 out of 46 items.  ",['230 people with cancer evaluating effectiveness of CBT for depression'],"['Therapy Component Checklist (TCC', 'TCC']","['TCCs', 'Self-rating of adherence saved']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1098189', 'cui_str': 'tetrakis(2-amino-5-ethyl-1,3,4-thiadiazole-N3)chlorocopper(II) chloride'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]",230.0,0.0401702,"Prevalence-adjusted and bias-adjusted kappa scores suggested substantial agreement, (>0.60) in 38 out of 46 items.  ","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Serfaty', 'Affiliation': 'Division of Psychiatry, University College London , London, UK.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Shafran', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, University College London , London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Vickerstaff', 'Affiliation': 'Marie Curie Palliative Care Research Department, University College London , London, UK.'}, {'ForeName': 'Trefor', 'Initials': 'T', 'LastName': 'Aspden', 'Affiliation': 'Division of Psychiatry, University College London , London, UK.'}]",Cognitive behaviour therapy,['10.1080/16506073.2020.1717594']
3146,24111267,SEMG pattern classification using hierarchical Bayesian model.,"This work addresses surface electromyogram (sEMG)-based muscle pattern classification using a generative model. By using a hierarchical Bayesian model, the proposed approach constructs an overall process model of recorded sEMG signals. By inferring probabilistically latent neural states which governs a collection of training sEMG data, classification is realized. To validate the approach, eight-class classification using four sEMG sensors on the limb actions is tested with five subjects. The proposed model achieves an overall 95% accuracy in the classification experiment. The results support that the proposed approach is very promising for sEMG pattern classification.",2013,The proposed model achieves an overall 95% accuracy in the classification experiment.,[],[],[],[],[],[],,0.0129902,The proposed model achieves an overall 95% accuracy in the classification experiment.,"[{'ForeName': 'Hyonyoung', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Sungho', 'Initials': 'S', 'LastName': 'Jo', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2013.6611080']
3147,32271500,Practitioners' application of Let's Talk about Children intervention in adult mental health services.,"Family-focused interventions can improve outcomes for families where a parent has a mental illness. One such intervention, Let's Talk about Children (Let's Talk), is a series of parent-practitioner conversations in adult mental health with demonstrated improved outcomes for child, parent, and family well-being. This study used a questionnaire to understand the application of Let's Talk by n = 73 trained practitioners from eight adult mental health services who were previously involved in a randomized controlled study in Victoria, Australia. Data were analysed to establish the application of Let's Talk, and statistical analyses were undertaken to identify what influenced practitioners' delivery of Let's Talk. The study details how practitioners used Let's Talk and indicates that most used it as designed, with the majority offering it to parents and approximately 40% delivering it. The findings indicate there is a decline over time in both the number of practitioners using Let's Talk and the number of deliveries over time. Practitioners' use of Let's Talk was influenced by their gender, profession, access to support, time since training, and caseload. The article discusses the implications of these results for sustaining Let's Talk in adult mental health services. While this study gives a baseline of practitioners' application of Let's Talk, further exploration of the experience of practitioners and parents as well as other system factors will be helpful to understand barriers and enablers to continued practice.",2020,"Practitioners' use of Let's Talk was influenced by their gender, profession, access to support, time since training, and caseload.","['73 trained practitioners from eight adult mental health services who were previously involved in a randomized controlled study in Victoria, Australia', 'adult mental health services']",[],[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],[],73.0,0.0338073,"Practitioners' use of Let's Talk was influenced by their gender, profession, access to support, time since training, and caseload.","[{'ForeName': 'Becca', 'Initials': 'B', 'LastName': 'Allchin', 'Affiliation': 'School of Rural Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Vic., Australia.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': ""O'Hanlon"", 'Affiliation': 'The Bouverie Centre, La Trobe University, Melbourne, Vic., Australia.'}, {'ForeName': 'Bente M', 'Initials': 'BM', 'LastName': 'Weimand', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Goodyear', 'Affiliation': 'School of Rural Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Vic., Australia.'}]",International journal of mental health nursing,['10.1111/inm.12724']
3148,32126840,Computer-delivered personalized feedback intervention for hazardous drinkers with elevated anxiety sensitivity: Study protocol for a randomized controlled trial.,"Integrated treatments for hazardous drinking and anxiety/depression are virtually nonexistent. Anxiety sensitivity is a common mechanism for both anxiety/depression and hazardous drinking. This article presents a study protocol for the development and testing of an integrated remotely delivered anxiety sensitivity/hazardous drinking personalized feedback intervention. Hazardous drinking college students with elevated anxiety sensitivity ( n  = 130) will be randomly assigned to a single session of a novel integrated personalized feedback intervention for anxiety sensitivity/hazardous drinking or control condition. Follow-ups will occur at 1 week, 1 month, and 3 months. This study will serve as an initial test and proof of concept for an integrated anxiety sensitivity/hazardous drinking personalized feedback intervention.",2020,This study will serve as an initial test and proof of concept for an integrated anxiety sensitivity/hazardous drinking personalized feedback intervention.,"['hazardous drinkers with elevated anxiety sensitivity', 'Hazardous drinking college students with elevated anxiety sensitivity ( n \u2009=\u2009130']","['novel integrated personalized feedback intervention for anxiety sensitivity/hazardous drinking or control condition', 'Computer-delivered personalized feedback intervention']",['Anxiety sensitivity'],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",130.0,0.0418448,This study will serve as an initial test and proof of concept for an integrated anxiety sensitivity/hazardous drinking personalized feedback intervention.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Paulus', 'Affiliation': 'Medical University of South Carolina, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'University of Houston, USA.'}, {'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'University of Houston, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'University of Houston, USA.'}]",Journal of health psychology,['10.1177/1359105320909858']
3149,19964700,UK and Canadian perspectives of the effectiveness of mobile diabetes management systems.,"The use of mobile technologies for self-monitoring of blood glucose and blood pressure for diabetes patients is becoming increasingly popular worldwide. This is propelled by the proliferation of the wider usage of mobile phones and other wireless technologies and computing platforms in the healthcare sector. Such technologies can play a pivotal role in chronic disease management and patient self-care. There have been several clinical trials in recent years on mobile diabetes management in UK and Canada. However, no studies to date have addressed and correlated the technological and clinical outcomes concerning the use of mobile chronic disease management systems for diabetes from the UK and Canadian perspectives. In this paper we address some of these correlative issues based on similar clinical trials on mobile type-2 diabetes management systems deployed in these two countries. In particular, the outcomes of these trials supported the use of telemonitoring for effective blood pressure control, but telemonitoring was less effective at managing blood glucose control. Some of the clinical results and challenges are presented together with future work and suggestions that aim to validate a generic platform for mobile diabetes management.",2009,"However, no studies to date have addressed and correlated the technological and clinical outcomes concerning the use of mobile chronic disease management systems for diabetes from the UK and Canadian perspectives.",['diabetes patients'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],[],,0.0264862,"However, no studies to date have addressed and correlated the technological and clinical outcomes concerning the use of mobile chronic disease management systems for diabetes from the UK and Canadian perspectives.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Seto', 'Affiliation': 'Centre for Global eHealth Innovation, University Health Network, Toronto, ON, Canada. emily.seto@uhn.on.ca'}, {'ForeName': 'Robert S H', 'Initials': 'RS', 'LastName': 'Istepanian', 'Affiliation': ''}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Cafazzo', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Logan', 'Affiliation': ''}, {'ForeName': 'Ala', 'Initials': 'A', 'LastName': 'Sungoor', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/IEMBS.2009.5333998']
3150,32128561,Effect of a Home Pregnancy Test Intervention on Cohort Retention and Pregnancy Detection: A Randomized Trial.,"We conducted a parallel, nonblinded randomized trial to assess whether offering home pregnancy tests (HPTs) to preconception cohort study participants influenced cohort retention or pregnancy detection. Pregnancy Study Online participants were female, aged 21-45 years, attempting pregnancy, and not using fertility treatment. At enrollment (2017-2018), 1,493 participants with 6 or fewer cycles of attempt time were randomly assigned with 50% probability to receive 12 Clearblue visual HPTs plus the standard protocol (n = 720) or the standard protocol alone (n = 773). Women completed bimonthly questionnaires for 12 months or until conception, whichever came first. In intent-to-treat analyses, retention (≥1 follow-up) was higher in the HPT arm (n = 598; 83%) than the standard protocol arm (n = 535 (69%); mean difference = 15%, 95% CI: 10, 19). Mean time at first pregnancy testing was identical in both arms (2 days before expected menses), as was mean gestational weeks at first positive pregnancy test (4 weeks). Conception was reported by 78% of women in the HPT arm and 75% in the standard protocol arm. Spontaneous abortion was reported by 21% in the HPT arm (mean gestational weeks = 7) and 21% in the standard protocol arm (mean gestational weeks = 6). Randomization of HPTs was associated with greater cohort retention but had little impact on incidence or timing of pregnancy detection.",2020,"In intent-to-treat analyses, retention (≥1 follow-ups) was higher in the HPT arm (","['Pregnancy Study Online (PRESTO) participants were female, aged 21-45 years, attempting pregnancy, and not using fertility treatment', '1,493 participants with ≤6 cycles of attempt time']","['home pregnancy tests (HPT', 'Home Pregnancy Test Intervention', 'Clearblue visual HPTs plus the standard protocol (N=720) or the standard protocol']","['Mean time at first pregnancy testing', 'Conception', 'cohort retention or pregnancy detection', 'Cohort Retention and Pregnancy Detection', 'Spontaneous abortion']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy Tests'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0860096', 'cui_str': 'Primigravida (finding)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",1493.0,0.233746,"In intent-to-treat analyses, retention (≥1 follow-ups) was higher in the HPT arm (","[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Wise', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Tanran R', 'Initials': 'TR', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Sydney K', 'Initials': 'SK', 'LastName': 'Willis', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Amelia K', 'Initials': 'AK', 'LastName': 'Wesselink', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Rothman', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Hatch', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}]",American journal of epidemiology,['10.1093/aje/kwaa027']
3151,31401237,Impact of food odors signaling specific taste qualities and macronutrient content on saliva secretion and composition.,"Olfactory food cues can induce appetite for similar food products in humans. Odors may thus signal essential information about a foods' composition such as taste or even macronutrient content and may stimulate specific physiological responses in anticipation of food intake. Several studies have shown that sensory food cues could stimulate saliva secretion. However, potential differences between food odors in their effect on saliva secretion, or the effects of olfactory stimulation on changes in saliva composition remain to be elucidated. To gain more insight, we conducted two studies to determine the influence of various odors, representing different taste qualities (study 1) and macronutrients (study 2), on salivary biomarkers. In study 1, 36 participants were randomly exposed to no-odor, non-food, and odors signaling sweet, savory, and sour taste. In study 2, 60 participants were randomly exposed to no-odor, non-food, and odors signaling carbohydrates, protein, fat, and low-calorie food. For each condition, whole-mouth saliva was collected and saliva secretion rate determined. Furthermore, we determined mouth-watering perception (subjective salivation), visco-elasticity (study 1 only), mucin concentration, α-amylase and lingual lipase activity (study 2 only). For both studies, linear mixed model analyses showed that saliva secretion rate significantly increased by food odor exposure compared to no-odor and non-food conditions. However, no changes in salivary composition were observed. These findings indicate that food odors play a crucial role in anticipatory saliva responses and can thereby affect subsequent eating behavior.",2019,"For both studies, linear mixed model analyses showed that saliva secretion rate significantly increased by food odor exposure compared to no-odor and non-food conditions.","['humans', '36 participants were randomly exposed to no-odor, non-food, and odors signaling sweet, savory, and sour taste', '60 participants']",[],"['mouth-watering perception (subjective salivation), visco-elasticity (study 1 only), mucin concentration, α-amylase and lingual lipase activity', 'anticipatory saliva responses', 'saliva secretion', 'salivary composition', 'saliva secretion rate', 'saliva secretion and composition']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0028884', 'cui_str': 'Odors'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C1135885', 'cui_str': 'Savory'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}]",[],"[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0036104', 'cui_str': 'Salivation'}, {'cui': 'C0013764'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026682', 'cui_str': 'Mucins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201883', 'cui_str': 'Amylase measurement (procedure)'}, {'cui': 'C2349948', 'cui_str': 'Lingual (qualifier value)'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",60.0,0.0253746,"For both studies, linear mixed model analyses showed that saliva secretion rate significantly increased by food odor exposure compared to no-odor and non-food conditions.","[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Morquecho-Campos', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, 6708, WE Wageningen, the Netherlands. Electronic address: paulina.morquechocampos@wur.nl.'}, {'ForeName': 'Floris J', 'Initials': 'FJ', 'LastName': 'Bikker', 'Affiliation': 'Department of Oral Biochemistry, Academic Centre for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, 1081, LA Amsterdam, the Netherlands.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Nazmi', 'Affiliation': 'Department of Oral Biochemistry, Academic Centre for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, 1081, LA Amsterdam, the Netherlands.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'de Graaf', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, 6708, WE Wageningen, the Netherlands.'}, {'ForeName': 'Marja L', 'Initials': 'ML', 'LastName': 'Laine', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam, University of Amsterdam and VU University Amsterdam, 1081, LA Amsterdam, the Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Boesveldt', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, 6708, WE Wageningen, the Netherlands.'}]",Appetite,['10.1016/j.appet.2019.104399']
3152,31494152,Timing of high-intensity intermittent exercise affects ad libitum energy intake in overweight inactive men.,"The present study sought to clarify the impact of exercise intensity and timing on energy intake and appetite-related blood variables. Fourteen inactive overweight men were included in the study. Firstly, maximal aerobic power (MAP) was measured. Then, participants randomly performed 5 experimental sessions consisting of 30 min of steady-state exercise (SSE) at 50% of MAP, high-intensity intermittent exercise (HIIE) with 30s repetitions at MAP and 30s of passive recovery or no exercise (CTRL). Sessions were performed 1h (SSE 1h  and HIIE 1h ) or 2.5h (SSE 2.5h  and HIIE 2.5h ) after the consumption of a standardized breakfast. An ad libitum buffet was offered 3.5h after the completion of the breakfast. Absolute energy intake (EI) and relative energy intake (REI) (relative energy intake = energy intake - energy expenditure from exercise) were measured. Appetite (hunger, fullness and desire for specific foods) scores and circulating concentration of insulin and IL-6 were determined at 1h, 1.75h, 2.5h and 3.25h after breakfast while lactate was measured post-exercise. EI was greater after the CTRL session compared to HIIE 2.5h  (5045.9 ± 1873.5 kJ vs. 3716.1 ± 1688.7 kJ). REI was greater for the CTRL session (5045.9 ± 1873.5 kJ) than HIIE 1h  (3386.5 ± 1660.1 kJ), HIIE 2.5h  (2508.5 ± 1709.3 kJ) and SSE 2.5h  (3426.6 ± 1788.0 kJ). Higher hunger scores were observed following the CRTL session with respect to those of HIIE 2.5h . Insulin and IL-6 concentrations were greater after HIIE 1h  and SSE 1h  with respect to those obtained after HIIE 2.5h , SSE 2.5h  and CTRL. Lactate concentrations were higher in HIIE 1h  and HIIE 2.5h  compared to those of SSE 1h  and SSE 2.5h . These results show that HIIE performed 2.5h after a breakfast reduced appetite (hunger scores) and EI through mechanism that need to be characterized. This approach can be applied to individuals aiming to create an energetic deficit.",2019,"Appetite (hunger, fullness and desire for specific foods) scores and circulating concentration of insulin and IL-6 were determined at 1h, 1.75h, 2.5h and 3.25h after breakfast while lactate was measured post-exercise.","['Fourteen inactive overweight men', 'overweight inactive men']","['high-intensity intermittent exercise', '30\u202fmin of steady-state exercise (SSE) at 50% of MAP, high-intensity intermittent exercise (HIIE) with 30s repetitions at MAP and 30s of passive recovery or no exercise (CTRL']","['appetite (hunger scores', 'Insulin and IL-6 concentrations', 'maximal aerobic power (MAP', 'Lactate concentrations', 'Appetite (hunger, fullness and desire for specific foods) scores and circulating concentration of insulin and IL-6', 'REI', 'Absolute energy intake (EI) and relative energy intake (REI) (relative energy intake\u202f=\u202fenergy intake - energy expenditure from exercise', 'Higher hunger scores']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0024779', 'cui_str': 'Map'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",14.0,0.0451698,"Appetite (hunger, fullness and desire for specific foods) scores and circulating concentration of insulin and IL-6 were determined at 1h, 1.75h, 2.5h and 3.25h after breakfast while lactate was measured post-exercise.","[{'ForeName': 'Valéria Leme Gonçalves', 'Initials': 'VLG', 'LastName': 'Panissa', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil. Electronic address: valeriapanissa@usp.br.'}, {'ForeName': 'Ursula Ferreira', 'Initials': 'UF', 'LastName': 'Julio', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'St-Pierre', 'Affiliation': 'Department of Exercise Sciences, Université du Québec à Montréal, Québec, Canada; Centre de Recherche du CHU Sainte-Justine, Montréal, Québec, Canada.'}, {'ForeName': 'Alícia', 'Initials': 'A', 'LastName': 'Tavares da Silva Gomes', 'Affiliation': 'School of Public Health, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Renan Santos', 'Initials': 'RS', 'LastName': 'Caldeira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Postgraduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Postgraduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Monica Yuri', 'Initials': 'MY', 'LastName': 'Takito', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Franchini', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}]",Appetite,['10.1016/j.appet.2019.104443']
3153,31628428,Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study.,"RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. With a median (range) follow-up of 60 months (0.1-66), progression-free survival (PFS) and overall survival (OS) benefits for ibrutinib versus chlorambucil were sustained (PFS estimates at 5 years: 70% vs 12%; HR [95% CI]: 0.146 [0.098-0.218]; OS estimates at 5 years: 83% vs 68%; HR [95% CI]: 0.450 [0.266-0.761]). Ibrutinib benefit was also consistent in patients with high prognostic risk (TP53 mutation, 11q deletion, and/or unmutated IGHV) (PFS: HR [95% CI]: 0.083 [0.047-0.145]; OS: HR [95% CI]: 0.366 [0.181-0.736]). Investigator-assessed overall response rate was 92% with ibrutinib (complete response, 30%; 11% at primary analysis). Common grade ≥3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), hypertension (8%), anemia (7%), and hyponatremia (6%); occurrence of most events as well as discontinuations due to AEs decreased over time. Fifty-eight percent of patients continue to receive ibrutinib. Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.",2020,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"['patients with CLL/SLL', 'chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL', 'Patients aged ≥65 years (n\u2009=\u2009269']","['daily ibrutinib 420\u2009mg continuously or chlorambucil 0.5-0.8\u2009mg/kg for ≤12 cycles', 'first-line ibrutinib treatment', 'chlorambucil']","['hyponatremia', 'Investigator-assessed overall response rate', 'progression-free survival (PFS) and overall survival (OS) benefits', 'anemia', 'pneumonia', 'neutropenia', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0024303', 'cui_str': 'Lymphocytic lymphoma'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4555385', 'cui_str': 'Ibrutinib 420 MG'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",,0.152562,Single-agent ibrutinib demonstrated sustained PFS and OS benefit versus chlorambucil and increased depth of response over time.,"[{'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA. jaburger@mdanderson.org.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Owen', 'Affiliation': 'Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tedeschi', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Bairey', 'Affiliation': 'Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': 'The Leeds Teaching Hospitals, St. James Institute of Oncology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Devereux', 'Affiliation': 'Kings College Hospital, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Silesiam Medical University, Katowice, Poland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Indu', 'Initials': 'I', 'LastName': 'Lal', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dean', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'UCSD Moores Cancer Center, San Diego, CA, USA.'}]",Leukemia,['10.1038/s41375-019-0602-x']
3154,32124144,Targeting Oral Language and Listening Comprehension Development for Students with Autism Spectrum Disorder: A School-Based Pilot Study.,"This study investigates the effects of an integrated oral language and listening comprehension intervention for early elementary students with ASD. Students (n = 43) were randomly assigned to intervention or control comparison conditions, with intervention students receiving instruction in small groups of 3 or 4. Groups were led by special education classroom teachers 4 days per week across 20 weeks in the school year. Significant group differences were detected on measures of expressive vocabulary, narrative ability, and listening comprehension. This study provides preliminary evidence of the intervention's feasibility and effectiveness for intervening in language and early reading skills for students with ASD.",2020,"Significant group differences were detected on measures of expressive vocabulary, narrative ability, and listening comprehension.","['Students (n\u2009=\u200943', 'early elementary students with ASD', 'Students with Autism', 'students with ASD', 'Spectrum Disorder']","['integrated oral language and listening comprehension intervention', 'intervention or control comparison conditions, with intervention students receiving instruction in small groups of 3 or 4']","['expressive vocabulary, narrative ability, and listening comprehension']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",43.0,0.028336,"Significant group differences were detected on measures of expressive vocabulary, narrative ability, and listening comprehension.","[{'ForeName': 'Alyssa R', 'Initials': 'AR', 'LastName': 'Henry', 'Affiliation': 'Curry School of Education and Human Development, University of Virginia, 405 Emmet Street, Charlottesville, VA, 22904, USA. arh2n@virginia.edu.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Solari', 'Affiliation': 'Curry School of Education and Human Development, University of Virginia, 405 Emmet Street, Charlottesville, VA, 22904, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04434-2']
3155,31401603,High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol.,"INTRODUCTION


Non-invasive ventilation (NIV) is recommended as first-line therapy in respiratory failure of critically ill immunocompromised patients as it can decrease intubation and mortality rates as compared with standard oxygen. However, its recommendation is only conditional. Indeed, the use of NIV in this setting has been challenged recently based on results of trials finding similar outcomes with or without NIV or even deleterious effects of NIV. To date, NIV has been compared with standard oxygen but not to high-flow nasal oxygen therapy (HFOT) in immunocompromised patients. Several studies have found lower mortality rates using HFOT alone than when using HFOT with NIV sessions in patients with de novo respiratory failure, and even in immunocompromised patients. We are hypothesising that HFOT alone is more effective than HFOT with NIV sessions and reduces mortality of immunocompromised patients with acute hypoxemic respiratory failure.
METHODS AND ANALYSIS


This study is an investigator-initiated, multicentre randomised controlled trial comparing HFOT alone or with NIV in immunocompromised patients admitted to intensive care unit (ICU) for severe acute hypoxemic respiratory failure. Around 280 patients will be randomised with a 1:1 ratio in two groups. The primary outcome is the mortality rate at day 28 after inclusion. Secondary outcomes include the rate of intubation in each group, length of ICU and hospital stay and mortality up to day 180.
ETHICS AND DISSEMINATION


The study has been approved by the ethics committee and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT02978300.",2019,"Secondary outcomes include the rate of intubation in each group, length of ICU and hospital stay and mortality up to day 180.
","['280 patients', 'immunocompromised patients admitted to intensive care unit (ICU) for severe acute hypoxemic respiratory failure', 'immunocompromised patients', 'immunocompromised patients with acute hypoxemic respiratory failure', 'immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure']","['HFOT alone or with NIV', 'HFOT with NIV sessions', 'Non-invasive ventilation (NIV', 'High-flow nasal oxygen therapy alone or with non-invasive ventilation', 'high-flow nasal oxygen therapy (HFOT', 'HFOT']","['rate of intubation in each group, length of ICU and hospital stay and mortality up to day 180', 'mortality rate', 'mortality rates', 'intubation and mortality rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit (procedure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4039867', 'cui_str': 'Acute type 1 respiratory failure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",280.0,0.183442,"Secondary outcomes include the rate of intubation in each group, length of ICU and hospital stay and mortality up to day 180.
","[{'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Coudroy', 'Affiliation': 'Médecine Intensive et Réanimation, INSERM CIC 1402, groupe ALIVE, Université de Poitiers, CHU de Poitiers, Poitiers, France r.coudroy@yahoo.fr.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': 'Médecine Intensive et Réanimation, INSERM CIC 1402, groupe ALIVE, Université de Poitiers, CHU de Poitiers, Poitiers, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': ""Médecine Intensive et Réanimation, CIC 1415, CRICS-TriggerSEP research network, Centre d'étude des pathologies respiratoires, INSERM U1100, Université de Tours, CHRU de Tours, Tours, France.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pène', 'Affiliation': 'Médecine Intensive et Réanimation, Université Paris Descartes, Hôpital Cochin, APHP, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Terzi', 'Affiliation': 'Médecine Intensive et Réanimation, INSERM, Université Grenoble-Alpes, U1042, HP2, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Maxens', 'Initials': 'M', 'LastName': 'Decavèle', 'Affiliation': 'Service de Pneumologie, Médecine Intensive et Réanimation, Département R3S, AP-HP, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Paris, France.'}, {'ForeName': 'Gwenaël', 'Initials': 'G', 'LastName': 'Prat', 'Affiliation': 'Médecine Intensive et Réanimation, CHU de Brest, Brest, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Garret', 'Affiliation': 'Médecine Intensive et Réanimation, CHU de Nantes, Nantes, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Contou', 'Affiliation': 'Service de Réanimation Polyvalente, Centre Hospitalier Victor Dupouy, Argenteuil, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': 'Médecine Intensive et Réanimation, Réanimation des Urgences, Aix-Marseille Université, CHU La Timone 2, Marseille, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gacouin', 'Affiliation': 'Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes, Hôpital Ponchaillou, Rennes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Girault', 'Affiliation': 'Service de Réanimation Médicale, Normandie Univ, Unirouen, UPRES EA-3830, Hôpital Charles Nicolle, CHU de Rouen, Rouen, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dellamonica', 'Affiliation': 'Médecine Intensive Réanimation, CHU de Nice, Nice, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Malacrino', 'Affiliation': 'Service de Réanimation, Centre hospitalier de Béthune, Beuvry, France.'}, {'ForeName': 'Guylaine', 'Initials': 'G', 'LastName': 'Labro', 'Affiliation': 'Medical Intensive Care Unit, Research Center EA3920, University of Franche-Comté, Hôpital Jean Minjoz, Besançon, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': ""Service de Médecine Intensive-Réanimation, INSERM U1231, Equipe Lipness, Université Bourgogne-Franche-Comté, UMR1231 Lipides, Nutrition, Cancer, équipe Lipness, LipSTIC LabEx, Fondation de coopération scientifique Bourgogne-Franche-Comté, INSERM, CIC 1432, Module Epidémiologie Clinique, Centre d'Investigation Clinique, Module Epidémiologie Clinique/Essais Cliniques, CHU Dijon, Dijon, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Herbland', 'Affiliation': 'Service de Réanimation, Centre hospitalier Saint Louis, La Rochelle, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Jochmans', 'Affiliation': 'Service de Réanimation, Centre hospitalier Sud-Ile-de France, Melun, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Devaquet', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Benzekri', 'Affiliation': ""Médecine Intensive et Réanimation, Groupe Hospitalier Régional d'Orléans, Orléans, France.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Vivier', 'Affiliation': 'Reanimation Polyvalente, Hôpital Saint Joseph Saint Luc, Lyon, France.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Nseir', 'Affiliation': 'Centre de Réanimation, Université de Lille, CHU de Lille, Lille, France.'}, {'ForeName': 'Gwenhaël', 'Initials': 'G', 'LastName': 'Colin', 'Affiliation': 'Service de Médecine Intensive et Réanimation, Centre Hospitalier Départemental de Vendée, La Roche-sur-Yon, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Thévenin', 'Affiliation': 'Service de Réanimation Polyvalente, CH de Lens, Lens, France.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesiology, Intensive Care and Emergency, Department of Pathophysiology and Transplantation, University of Milan, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Assefi', 'Affiliation': 'Multidisciplinary Intensive Care Unit, Department of Anesthesia and Critical Care Medicine, School of Medicine, University Pierre and Marie Curie (UPMC), Pitié-Salpétrière Hospital, APHP, Paris, France.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Guerin', 'Affiliation': 'Service de Médecine Intensive-Réanimation, Université de Lyon, INSERM 955, Créteil, Hôpital de La Croix-Rousse, Hospices civils de Lyon, Lyon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bougon', 'Affiliation': 'Service de Réanimation, Centre Hospitalier Annecy Genevois, Annecy, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lherm', 'Affiliation': 'Medical ICU, Hospital of Chartres, Coudray, France.'}, {'ForeName': 'Achille', 'Initials': 'A', 'LastName': 'Kouatchet', 'Affiliation': ""Medical ICU, CHU d'Angers, Angers, France.""}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': 'INSERM CIC 1402, Biostatistics, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': 'Médecine Intensive et Réanimation, INSERM CIC 1402, groupe ALIVE, Université de Poitiers, CHU de Poitiers, Poitiers, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-029798']
3156,31331773,"Immunogenicity and safety of a liquid Pentavalent (DTwP-Hb-Hib) combination vaccine manufactured by Human Biologicals Institute in 6-8 weeks old healthy infants: A phase III, randomized, single blind, non-inferiority study.","BACKGROUND


A liquid Pentavalent (DTwP-Hb-Hib) combination vaccine, developed by Human Biologicals Institute, underwent a Phase III clinical study in India. In this randomized, single blind, non-inferiority study, the immunogenicity and safety of this Investigational vaccine was compared with Pentavac SD® vaccine in 6-8 weeks old healthy infants.
METHODS


A total of 405 healthy infants aged 6-8 weeks old were randomized in 2:1 ratio to receive three doses of either the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine or Pentavac SD® vaccine at four to six weeks interval. Immunogenicity was compared by estimation of antibody titers before the first dose and 4-6 weeks after the third dose of vaccination. Safety of each vaccine was assessed and compared by collection of data on solicited and unsolicited adverse events throughout the study period.
RESULTS


Out of a total of 405 enrolled subjects, 387 subjects completed the study. The seroconversion rates, seroprotection rates and geometric mean titres of the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine group were found to be comparable and non-inferior to the Pentavac SD® vaccine group at 4-6 weeks after the third dose of vaccination. Pain, erythema and swelling at the site of injection were found to be the most common local adverse events whereas fever, irritability and unusual crying were found to be the most common systemic adverse events in both the vaccine groups. No vaccine related serious adverse event was reported. In this study, both the Investigational vaccine as well as the Comparator vaccine were found to be immunogenic and well tolerated.
CONCLUSION


After assessment of the results of the study it was concluded that the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine developed by Human Biologicals Institute was immunogenic and safe when administered to infants aged 6-8 weeks and was non-inferior in immunogenicity and safety to Pentavac SD® vaccine. Clinical Trial Registry of India Identifier: CTRI/2016/01/006541.",2019,"Pain, erythema and swelling at the site of injection were found to be the most common local adverse events whereas fever, irritability and unusual crying were found to be the most common systemic adverse events in both the vaccine groups.","['405 enrolled subjects, 387 subjects completed the study', '405 healthy infants aged 6-8\u202fweeks old', '6-8\u202fweeks old healthy infants']","['Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine', 'Pentavac SD® vaccine', 'liquid Pentavalent (DTwP-Hb-Hib) combination vaccine manufactured', 'liquid Pentavalent (DTwP-Hb-Hib) combination vaccine', 'Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine or Pentavac SD® vaccine']","['fever, irritability and unusual crying', 'immunogenicity and safety', 'Pain, erythema and swelling', 'immunogenic and well tolerated', 'Immunogenicity and safety', 'seroconversion rates, seroprotection rates and geometric mean titres', 'Immunogenicity', 'antibody titers']","[{'cui': 'C4517768', 'cui_str': 'Four hundred and five'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0206253', 'cui_str': 'Vaccines, Combination'}, {'cui': 'C0971597', 'cui_str': 'Pentavac'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}]",405.0,0.264193,"Pain, erythema and swelling at the site of injection were found to be the most common local adverse events whereas fever, irritability and unusual crying were found to be the most common systemic adverse events in both the vaccine groups.","[{'ForeName': 'Sai Krishna', 'Initials': 'SK', 'LastName': 'Susarla', 'Affiliation': 'Human Biologicals Institute, Hyderabad, India. Electronic address: s.saikrishna@indimmune.com.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Department of Community Medicine, School of Public Health, Postgraduate Institute of Medical Education & Research, Chandigarh, India.'}, {'ForeName': 'Mukta', 'Initials': 'M', 'LastName': 'Mantan', 'Affiliation': 'Department of Paediatrics, Maulana Azad Medical College, New Delhi, India.'}, {'ForeName': 'Ramchandra', 'Initials': 'R', 'LastName': 'Dhongade', 'Affiliation': 'Department of Paediatrics, Sant Dnyaneshwar Medical Education Research Centre, Pune, India.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Bhave', 'Affiliation': 'Paediatric Research, KEM Hospital Research Centre, Pune, India.'}, {'ForeName': 'Rajat Kumar', 'Initials': 'RK', 'LastName': 'Das', 'Affiliation': 'Department of Paediatrics, KPC Medical College and Hospital, Kolkata, India.'}, {'ForeName': 'Rajib Kumar', 'Initials': 'RK', 'LastName': 'Ray', 'Affiliation': 'Department of Paediatrics, Hi-Tech Medical College and Hospital, Bhubaneswar, India.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ramesh Babu', 'Affiliation': 'Department of Paediatrics, Gandhi Medical College and Hospital, Secunderabad, India.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Ravi', 'Affiliation': 'Department of Paediatrics, JSS Medical College & Hospital, Mysore, India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Krishnamurthy', 'Affiliation': 'Department of Paediatrics, Mysore Medical College and Research Institute, Mysore, India.'}, {'ForeName': 'Saji', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Pediatrics, Sri Ramachandra Medical Centre, Chennai, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sandhya', 'Affiliation': 'Human Biologicals Institute, Hyderabad, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Satish', 'Affiliation': 'Human Biologicals Institute, Hyderabad, India.'}, {'ForeName': 'Devi Prasad', 'Initials': 'DP', 'LastName': 'Sahoo', 'Affiliation': 'Human Biologicals Institute, Hyderabad, India.'}]",Vaccine,['10.1016/j.vaccine.2019.06.067']
3157,31399910,"Effects of dietary whole grain, fruit, and vegetables on weight and inflammatory biomarkers in overweight and obese women.","PURPOSE


The separate effects of whole grain (WG) and fruit and vegetable (F&V) diets on inflammatory biomarkers have not been assessed. Therefore, we evaluated these two high-fiber diets in relation to inflammation indices in obese and overweight women.
STUDY DESIGN


Parallel randomized clinical trial.
METHODS


In the present study, 75 women were recruited and randomly assigned to three diet groups: a whole grain diet (WG-D) group, F&V group, and a combined whole grain and F&V diet group (WGFV-D) for 10 weeks. As a ""feeding trial"" all participants were asked to visit the clinic daily and eat prescribed foods in the presence of a nutritionist. Anthropometric indices and biochemical biomarkers were measured at baseline and after 10 weeks of the trial.
RESULTS


Each of the three diet groups showed significant changes in serum biomarkers (CRP, TNF-α, IL-6, D-dimer, and serum fibrinogen) after following the diet for 10 weeks (P = 0.01). In adjusted models, significant changes were observed for CRP, TNF-α, IL-6, D-dimer, and serum fibrinogen (P = 0.01). In a model adjusted for malondialdehyde (MDA) level, a trend toward significance was observed (P = 0.05). Consumption of all three different diets for 10 weeks showed statistically significant change for all biomarkers (P < 0.05) the most notable changes in inflammatory indices were observed among participants following the WG diet.
CONCLUSIONS


Study results indicate that consumption of high-fiber diets, especially the WG diet, can help lower inflammatory levels and prevent subsequent adverse health consequences.
LEVEL OF EVIDENCE


Level I, randomized controlled trial.",2020,"Consumption of all three different diets for 10 weeks showed statistically significant change for all biomarkers (P < 0.05) the most notable changes in inflammatory indices were observed among participants following the WG diet.
","['75 women', 'obese and overweight women', 'overweight and obese women']","['dietary whole grain, fruit, and vegetables', 'whole grain diet (WG-D) group, F&V group, and a combined whole grain and F&V diet group (WGFV-D', 'whole grain (WG) and fruit and vegetable (F&V) diets']","['CRP, TNF-α, IL-6, D-dimer, and serum fibrinogen', 'inflammatory indices', 'Anthropometric indices and biochemical biomarkers', 'serum biomarkers (CRP, TNF-α, IL-6, D-dimer, and serum fibrinogen', 'malondialdehyde (MDA) level']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",75.0,0.0762832,"Consumption of all three different diets for 10 weeks showed statistically significant change for all biomarkers (P < 0.05) the most notable changes in inflammatory indices were observed among participants following the WG diet.
","[{'ForeName': 'Niloufar', 'Initials': 'N', 'LastName': 'Arabzadegan', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Daneshzad', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Fatahi', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedeh Parisa', 'Initials': 'SP', 'LastName': 'Moosavian', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Surkan', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Azadbakht', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran. l-azadbakht@sina.tums.ac.ir.'}]",Eating and weight disorders : EWD,['10.1007/s40519-019-00757-x']
3158,30638739,"Four-oil intravenous lipid emulsion effect on plasma fatty acid composition, inflammatory markers and clinical outcomes in acutely ill patients: A randomised control trial (Foil fact).","BACKGROUND AND AIMS


Data in critically ill patients on the effect of intravenous lipid emulsions (LEs), containing omega-3 polyunsaturated fatty acids (PUFAs), in parenteral nutrition (PN) are scarce and conflicting. This study compared the effects of a four-oil LE (30% soybean oil, 30% medium-chain triglycerides, 25% olive oil and 15% fish oil (FO)) (SMOFlipid®) to those of a 100% soybean oil-based LE in critically ill adult intensive care unit (ICU) patients.
METHODS


In this double-blind, randomised study, patients (n = 75) predicted to need PN for more than 5 days were randomised to receive either a four-oil LE (Study Group (SG)) or a 100% soybean oil LE (Control Group (CG)). Isocaloric, isonitrogenous PN was administered continuously for 5 days. FO was provided at a dose of 0.09-0.22 g/kg body weight. Measurements included biochemical parameters and sequential organ failure assessment (SOFA) score daily and plasma total phospholipid fatty acids (FAs) and cytokine levels on days 1, 3, 6. Days on mechanical ventilation, length of stay and mortality were also recorded. ANOVA was used to compare response variables between the two groups over the time and Pearson correlation was used to measure relationships between continuous variables.
RESULTS


68 patients completed the study (n = 35 SG, n = 33 CG), with male predominance (66% SG, 56% CG). Average age was 60.8 ± 13.9 years (SG) versus 55.7 ± 14.8 (CG) (p = 0.143). The majority were surgical admissions (85% SG versus 91% CG) followed by medical. Plasma phospholipid oleic acid (p = 0.022) and alpha-linolenic acid (p<0.0005) increased in both groups. In the SG, plasma phospholipid EPA and DHA increased (both p<0.001), whereas the omega-6:omega-3 PUFA (n-6:n-3 PUFA) ratio decreased (p < 0.001). Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin decreased in both treatment groups. Considering only the change from day 1 to day 6 there was a bigger decrease in AST, ALT and bilirubin levels in the SG. Concentrations of TNF-α decreased from day 1 to day 6 in the SG, whereas they increased in the CG, but the change was not statistically significant (p = 0.112). A significant negative correlation was found between EPA provision on day 3 and the SOFA score (r = -0.4047, p = 0.018). Days on mechanical ventilation (1.24 ± 0.83 days in SG versus 0.88 ± 1.63 days in CG, p = 0.385) and ICU LOS (9.5 ± 7.09 days in SG versus 10.7 ± 7.6 days in CG, p = 0.490) were not different between groups.
CONCLUSION


PN containing a four-oil LE increased plasma EPA and DHA, decreased n-6:n-3 PUFA ratio, and was safe and well tolerated. The negative relationship between day 3 EPA and SOFA score seems promising, but EPA intake and effects may have been diluted by enteral nutrition which was started in more than half of patients on day 4. There was no significant difference in terms of other biochemical measurements, SOFA score, length of ICU stay and mortality. More research is needed in this patient population, particularly regarding dose, duration and timing of FO and the effects on clinical outcomes.",2019,Plasma phospholipid oleic acid (p = 0.022) and alpha-linolenic acid (p<0.0005) increased in both groups.,"['patients (n\xa0=\xa075) predicted to need PN for more than 5 days', 'critically ill adult intensive care unit (ICU) patients', '68 patients completed the study (n\xa0=\xa035 SG, n\xa0=\xa033 CG), with male predominance (66% SG, 56% CG', 'critically ill patients', 'acutely ill patients']","['four-oil LE (30% soybean oil, 30% medium-chain triglycerides, 25% olive oil and 15% fish oil (FO', 'intravenous lipid emulsions (LEs), containing omega-3 polyunsaturated fatty acids (PUFAs', 'soybean oil-based LE', 'four-oil LE (Study Group (SG)) or a 100% soybean oil LE (Control Group (CG', 'Isocaloric, isonitrogenous PN']","['plasma fatty acid composition, inflammatory markers and clinical outcomes', 'safe and well tolerated', 'biochemical parameters and sequential organ failure assessment (SOFA) score daily and plasma total phospholipid fatty acids (FAs) and cytokine levels', 'plasma EPA and DHA, decreased n-6:n-3 PUFA ratio', 'mechanical ventilation, length of stay and mortality', 'Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin', 'mechanical ventilation', 'biochemical measurements, SOFA score, length of ICU stay and mortality', 'alpha-linolenic acid', 'omega-6:omega-3 PUFA (n-6:n-3 PUFA) ratio', 'Plasma phospholipid oleic acid', 'plasma phospholipid EPA and DHA', 'AST, ALT and bilirubin levels', 'Concentrations of TNF-α', 'SOFA score', 'ICU LOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0015667', 'cui_str': 'Lipid Emulsions, Intravenous'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1168488', 'cui_str': 'Total phospholipids'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0051405', 'cui_str': '9,12,15-Octadecatrienoic acid, (Z,Z,Z)-'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0028929', 'cui_str': 'Oleic Acids'}, {'cui': 'C0344395', 'cui_str': 'Bilirubin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]",,0.199075,Plasma phospholipid oleic acid (p = 0.022) and alpha-linolenic acid (p<0.0005) increased in both groups.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Donoghue', 'Affiliation': 'Division of Human Nutrition, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa. Electronic address: veronique.donoghue@gmail.com.'}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Schleicher', 'Affiliation': 'Wits Donald Gordon Medical Centre ICU, Parktown, Johannesburg, South Africa.'}, {'ForeName': 'M G L', 'Initials': 'MGL', 'LastName': 'Spruyt', 'Affiliation': 'Critical Care, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Malan', 'Affiliation': 'Centre of Excellence for Nutrition, North-West University, Potchefstroom Campus, South Africa.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Nel', 'Affiliation': 'Centre for Statistical Consultation, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'Faculty of Medicine, University of Southampton, UK and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Blaauw', 'Affiliation': 'Division of Human Nutrition, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.12.010']
3159,31866099,Reduction in mouse allergen exposure is associated with greater lung function growth.,"BACKGROUND


Current childhood asthma therapies have little effect on lung function trajectory.
OBJECTIVE


We sought to determine whether mouse allergen exposure reduction is associated with lung function growth in mouse-sensitized/exposed asthmatic children.
METHODS


Three hundred fifty mouse-sensitized/exposed asthmatic children (5-17 years old) were enrolled in a 1-year randomized trial of integrated pest management plus education versus education alone. Prebronchodilator/postbronchodilator spirometry was performed at baseline and 6 and 12 months, and bedroom floor mouse allergen levels were measured every 3 months. Mouse allergen reduction was defined as a 75% or greater decrease in mouse allergen levels from baseline. Treatment groups were combined for analyses because there were no differences in outcomes between groups. Changes in lung function over time were modeled, adjusting for age, sex, race, atopy, group, and bronchodilator reversibility and including an interaction term (allergen reduction*time).
RESULTS


The study population was predominantly black (79.4%) and low income (66.3% [<$30,000]). At baseline, the median mouse allergen level was 5.7 μg/g (interquartile range, 1.5-22.8 μg/g), and the mean (SD) prebronchodilator FEV 1 /forced vital capacity ratio was 80.2% (9.0%). Ninety-two (26.3%) participants had 75% or greater reduction in mouse allergen levels. For a 10-year-old black boy, 75% or greater allergen reduction was associated with an increase in prebronchodilator FEV 1  of 238 mL/y (95% CI, 177-299 mL/y), whereas less than 75% allergen reduction was associated with an increase in prebronchodilator FEV 1  of 131 mL/y (95% CI, 97-166 mL/y). Estimated differences in prebronchodilator and postbronchodilator FEV 1  growth were as follows: 107 mL/y (95% CI, 37-177 mL/y; P int  = .003) and 48 mL/y (95% CI, -17 to 113 mL/y; P int  = .15), respectively. Estimated differences in prebronchodilator and postbronchodilator forced expiratory flow at 25% to 75% of vital capacity growth were as follows: 182 mL/y (95% CI, 61-304 mL/y; P int  = .003) and 181 mL/y (95% CI, 48-314 mL/y; P int  = .008), respectively.
CONCLUSION


Mouse allergen reduction is associated with greater increases in prebronchodilator FEV 1  and prebronchodilator/postbronchodilator forced expiratory flow at 25% to 75% of vital capacity over 1 year among sensitized/exposed asthmatic children.",2020,Ninety-two (26.3%) participants had 75% or greater reduction in mouse allergen levels.,"['Three hundred fifty mouse-sensitized/exposed asthmatic children (5-17 years old', 'The study population was predominantly black (79.4%) and low income (66.3% [<$30,000', 'mouse-sensitized/exposed asthmatic children']","['Prebronchodilator/postbronchodilator spirometry', 'integrated pest management plus education versus education alone']","['median mouse allergen level', 'prebronchodilator FEV', 'prebronchodilator and postbronchodilator forced expiratory flow', 'mouse allergen levels', 'prebronchodilator FEV 1  and prebronchodilator/postbronchodilator forced expiratory flow', 'mean (SD) prebronchodilator FEV 1 /forced vital capacity ratio']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}]","[{'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0031249', 'cui_str': 'Pest Management'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",350.0,0.180617,Ninety-two (26.3%) participants had 75% or greater reduction in mouse allergen levels.,"[{'ForeName': 'Torie', 'Initials': 'T', 'LastName': 'Grant', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Pediatric Allergy/Immunology, Boston Children's Hospital, Harvard University Medical School, Boston, Mass.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Perzanowski', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, New York, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Balcer-Whaley', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Peng', 'Affiliation': 'Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Curtin-Brosnan', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Newman', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Amparito', 'Initials': 'A', 'LastName': 'Cunningham', 'Affiliation': ""Division of Pediatric Allergy/Immunology, Boston Children's Hospital, Harvard University Medical School, Boston, Mass.""}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Divjan', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, New York, NY.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Bollinger', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Md.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Divisions of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Matsui', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md; Departments of Population Health and Pediatrics, Dell Medical School at University of Texas at Austin, Austin, Tex. Electronic address: elizabeth.matsui@austin.utexas.edu.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.08.043']
3160,31628930,Oxytocin reduces post-stress sweet snack intake in women without attenuating salivary cortisol.,"Intranasal oxytocin produces anorectic effects on snack intake in men when tested in the absence of deprivation-induced hunger, but its effects on food intake in women without eating disorders have not been reported. Oxytocin may reduce food intake by reducing stress eating, since it inhibits ACTH release. The present study adopted a double-blind, repeated measures and fully concealed crossover protocol in which 38 women self-administered 24 IU of oxytocin or placebo intranasally, ate lunch, and underwent two consecutive stress tests. Snack intake was assessed 15-20 min after lunch, via a sham taste test. Salivary cortisol was measured throughout the test period every 15 min. Oxytocin significantly reduced sweet fatty snack intake independently of any effect on salivary cortisol, which declined over time at a similar rate after either drug or placebo. Ratings of sweet taste were slightly reduced by oxytocin, but only in self-reported stress eaters. These results differ from previous studies with men that found an effect of oxytocin on postprandial cortisol levels. However, previous research assayed the less active form of plasma cortisol and did not control for protein intake, which can drive elevated cortisol. The finding that oxytocin reduces snack intake in females after acute stress has important implications for appetite regulation and its treatment in obese people and in those with eating disorders.",2019,"Intranasal oxytocin produces anorectic effects on snack intake in men when tested in the absence of deprivation-induced hunger, but its effects on food intake in women without eating disorders have not been reported.","['females after acute stress', '38 women self-administered 24 IU of', 'women without eating disorders', 'women without attenuating salivary cortisol']","['oxytocin', 'placebo', 'Intranasal oxytocin', 'Oxytocin', 'oxytocin or placebo']","['sweet fatty snack intake', 'postprandial cortisol levels', 'Snack intake', 'salivary cortisol', 'Salivary cortisol', 'Ratings of sweet taste']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}]",38.0,0.331523,"Intranasal oxytocin produces anorectic effects on snack intake in men when tested in the absence of deprivation-induced hunger, but its effects on food intake in women without eating disorders have not been reported.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Burmester', 'Affiliation': 'Department of Psychology, School of Law, Social and Behavioural Sciences, Kingston University, Penrhyn Road, Kingston upon Thames, Surrey KT1 2EE, UK.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Gibson', 'Affiliation': 'Department of Psychology, Whitelands College, University of Roehampton, London SW15 4JD, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Butler', 'Affiliation': 'Department of Psychology, School of Law, Social and Behavioural Sciences, Kingston University, Penrhyn Road, Kingston upon Thames, Surrey KT1 2EE, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': ""Institute of Medical and Biomedical Education, St George's, University of London, Cranmer Terrace, London SW17 0RE, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Terry', 'Affiliation': 'Department of Psychology, School of Law, Social and Behavioural Sciences, Kingston University, Penrhyn Road, Kingston upon Thames, Surrey KT1 2EE, UK. Electronic address: p.terry@kingston.ac.uk.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112704']
3161,32106328,The Renal Resistive Index in Allografts: Is Sonographic Assessment Sufficiently Reproducible in a Routine Clinical Setting? - Reproducibility of the Renal Resistive Index.,"PURPOSE


To assess the reproducibility of the renal resistive index (RRI) in a routine clinical setting.
MATERIALS AND METHODS


22 patients with a kidney allograft and 19 physicians participated in our prospective study. Within 2 hours each patient was examined by 5 different physicians using 2 out of 3 different, randomly allocated ultrasound machines. Each investigator determined the hilar and parenchymal RRI of the allograft. The reproducibility and reproducibility limit of the RRI were assessed as well as Cronbach's alpha and the intraclass correlation coefficient (ICC). The deviation of the RRI from the mean RRI over the 5 measurements was used as an indicator of reproducibility. The impact of the ultrasound machine, examiner's level of experience, and kidney function impairment (GFR < 45 ml/min) was assessed with the Kruskal-Wallis test. The bivariate linear correlation of the minimal transplant distance from the body surface with the variance of the parenchymal RRI was analyzed.
RESULTS


A reproducibility of 0.045 with a reproducibility limit of 0.124 was found for the parenchymal RRI. The ICC between RRIs was good with 0.852 for the parenchymal RRI and 0.868 for the hilar RRI. The type of ultrasound machine used was found to have a significant impact on the deviation of the parenchymal RRI (Kruskal-Wallis-Test, p = 0.003). Variance in serial parenchymal RRI measurements correlated significantly with the depth of the kidney transplant (p = 0.001).
CONCLUSION


While the RRI is generally sufficiently reproducible, the type of ultrasound machine used and the depth of the kidney transplant within the recipient's body have a significant impact on reproducibility.
KEY POINTS


· The renal resistive index (RRI) in allografts is reproducible.. · The type of ultrasound machine has an impact on the measured RRI.. · RRI reproducibility decreases with the depth of the renal allograft in the recipient..
CITATION FORMAT


· Theilig DC, Münzfeld H, Auer TA et al. The Renal Resistive Index in Allografts: Is Sonographic Assessment Sufficiently Reproducible in a Routine Clinical Setting?. Fortschr Röntgenstr 2020; 192: 561 - 566.",2020,"The type of ultrasound machine has an impact on the measured RRI.. · RRI reproducibility decreases with the depth of the renal allograft in the recipient..
CITATION FORMAT


· Theilig DC, Münzfeld H, Auer TA et al.",['22 patients with a kidney allograft and 19 physicians participated in our prospective study'],[],"['Variance in serial parenchymal RRI measurements', 'reproducibility of the renal resistive index (RRI', 'Renal Resistive Index in Allografts', 'hilar and parenchymal RRI of the allograft', 'reproducibility and reproducibility limit of the RRI', 'deviation of the parenchymal RRI', 'renal resistive index (RRI', 'Renal Resistive Index', ' Reproducibility of the Renal Resistive Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]",[],"[{'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]",22.0,0.0197898,"The type of ultrasound machine has an impact on the measured RRI.. · RRI reproducibility decreases with the depth of the renal allograft in the recipient..
CITATION FORMAT


· Theilig DC, Münzfeld H, Auer TA et al.","[{'ForeName': 'Dorothea Cornelia', 'Initials': 'DC', 'LastName': 'Theilig', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Münzfeld', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Timo Alexander', 'Initials': 'TA', 'LastName': 'Auer', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Feldhaus', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Krüger', 'Affiliation': 'Division of Nephrology and Internal Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dürr', 'Affiliation': 'Division of Nephrology and Internal Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Geisel', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Germany.'}]",RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin,['10.1055/a-1086-5191']
3162,32096595,A comparison of MTA and Biodentine as medicaments for pulpotomy in traumatized anterior immature permanent teeth: A randomized clinical trial.,"BACKGROUND/AIM


The placement of a biocompatible material after performing pulp therapy in traumatically exposed permanent incisors is one of the important factors that determine pulp healing. The aim of this study was to assess the clinical and radiographic outcomes when using mineral trioxide aggregate (MTA) and Biodentine as pulpotomy materials to maintain the vitality of traumatized immature anterior permanent teeth with pulp exposure.
MATERIALS AND METHODS


Fifty traumatized immature anterior permanent teeth with exposed pulps were included in the study. Teeth were equally divided and randomly assigned to two groups MTA or Biodentine. After pulpotomy, pulp stumps were covered with MTA or Biodentine followed by a permanent restoration. Blinded clinical and radiographic evaluations were performed at baseline, immediate post-operative and after 6, 12 and 18 months according to pre-determined clinical and radiographic criteria.
RESULTS


No statistically significant differences were observed between MTA and Biodentine for any of the clinical parameters, except for discoloration, which was significantly more prevalent in the MTA group (P < .001). No significant statistical difference was observed in the radiographic outcomes between MTA and Biodentine, as evidenced by continued root development and by an increased prevalence of root formation stage H in both groups.
CONCLUSIONS


Both MTA and Biodentine showed similar clinical and radiographic outcomes when used as pulpotomy materials in the treatment of traumatized immature anterior permanent teeth. However, discoloration was significantly more prevalent in the MTA group.",2020,"No statistically significant differences were observed between MTA and Biodentine for any of the clinical parameters, except for discoloration, which was significantly more prevalent in the MTA group (p<0.001).","['traumatized immature anterior permanent teeth with pulp exposure', 'Traumatized Anterior Immature Permanent Teeth', 'traumatized immature anterior permanent teeth', 'Fifty traumatized immature anterior permanent teeth with exposed pulps were included in the study']","['MTA and Biodentine', 'mineral trioxide aggregate (MTA) and Biodentine', 'MTA or Biodentine', 'MTA']","['discoloration', 'radiographic outcomes', 'prevalence of root formation stage H']","[{'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0348070', 'cui_str': 'Dentition, Adult'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}]","[{'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]",,0.0411077,"No statistically significant differences were observed between MTA and Biodentine for any of the clinical parameters, except for discoloration, which was significantly more prevalent in the MTA group (p<0.001).","[{'ForeName': 'Gihan Mohamed', 'Initials': 'GM', 'LastName': 'Abuelniel', 'Affiliation': 'Cairo University, Cairo, Egypt.'}, {'ForeName': 'Monty Singh', 'Initials': 'MS', 'LastName': 'Duggal', 'Affiliation': 'National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Kabel', 'Affiliation': 'Misr University for Sciences and Technology, 6th of October City, Egypt.'}]",Dental traumatology : official publication of International Association for Dental Traumatology,['10.1111/edt.12553']
3163,31805854,The influence of dexmedetomidine and propofol on circulating cytokine levels in healthy subjects.,"BACKGROUND


Surgery and diseases modify inflammatory responses and the immune system. Anesthetic agents also have effects on the human immune system but the responses they induce may be altered or masked by the surgical procedures or underlying illnesses. The aim of this study was to assess how single-drug dexmedetomidine and propofol anesthesia without any surgical intervention alter acute immunological biomarkers in healthy subjects.
METHODS


Thirty-five healthy, young male subjects were anesthetized using increasing concentrations of dexmedetomidine (n = 18) or propofol (n = 17) until loss of responsiveness (LOR) was detected. The treatment allocation was randomized. Multi-parametric immunoassays for the detection of 48 cytokines, chemokines and growth factors were used. Concentrations were determined at baseline and at the highest drug concentration for each subject.
RESULTS


The changes in the concentration of eotaxin (decrease after dexmedetomidine) and platelet-derived growth factor (PDGF, increase after propofol) were statistically significantly different between the groups. Significant changes were detected within both groups; the concentrations of monocyte chemotactic protein 1, chemokine ligand 27 and macrophage migration inhibitory factor were lower in both groups after the drug administration. Dexmedetomidine decreased the concentration of eotaxin, interleukin-18, interleukin-2Rα, stem cell factor, stem cell growth factor and vascular endothelial growth factor, and propofol decreased significantly the levels of hepatocyte growth factor, IFN-γ-induced protein 10 and monokine induced by IFN-γ, and increased the levels of interleukin-17, interleukin-5, interleukin-7 and PDGF.
CONCLUSIONS


Dexmedetomidine seemed to have an immunosuppressive effect on the immune system whereas propofol seemed to induce mixed pro- and anti-inflammatory effects on the immune system. The choice of anesthetic agent could be relevant when treating patients with compromised immunological defense mechanisms.
TRIAL REGISTRATION


Before subject enrollment, the study was registered in the European Clinical Trials database (EudraCT number 2013-001496-21, The Neural Mechanisms of Anesthesia and Human Consciousness) and in ClinicalTrials.gov (Principal Investigator: Harry Scheinin, number NCT01889004, The Neural Mechanisms of Anesthesia and Human Consciousness, Part 2, on the 23rd of June 2013).",2019,"Significant changes were detected within both groups; the concentrations of monocyte chemotactic protein 1, chemokine ligand 27 and macrophage migration inhibitory factor were lower in both groups after the drug administration.","['Thirty-five healthy, young male subjects', 'patients with compromised immunological defense mechanisms', 'healthy subjects']","['propofol', 'dexmedetomidine and propofol', 'dexmedetomidine', 'Dexmedetomidine', 'propofol anesthesia without any surgical intervention']","['concentration of eotaxin', 'acute immunological biomarkers', 'levels of hepatocyte growth factor, IFN-γ-induced protein 10 and monokine induced by IFN-γ, and increased the levels of interleukin-17, interleukin-5, interleukin-7 and PDGF', 'concentration of eotaxin, interleukin-18, interleukin-2Rα, stem cell factor, stem cell growth factor and vascular endothelial growth factor, and propofol', 'circulating cytokine levels', 'platelet-derived growth factor (PDGF', 'concentrations of monocyte chemotactic protein 1, chemokine ligand 27 and macrophage migration inhibitory factor']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0011142', 'cui_str': 'Defense Mechanisms'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0062534', 'cui_str': 'Hepatopoietin'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0026484', 'cui_str': 'Monokines'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0384648', 'cui_str': 'IL-17'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0021761', 'cui_str': 'Interleukin-7'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0143630', 'cui_str': 'Mast Cell Growth Factor'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0032200', 'cui_str': 'Platelet-Derived Growth Factor'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0024429', 'cui_str': 'Migration Inhibition Factors, Macrophage'}]",35.0,0.102537,"Significant changes were detected within both groups; the concentrations of monocyte chemotactic protein 1, chemokine ligand 27 and macrophage migration inhibitory factor were lower in both groups after the drug administration.","[{'ForeName': 'Minna', 'Initials': 'M', 'LastName': 'Kallioinen', 'Affiliation': 'Department of Perioperative Services, Intensive Care and Pain Medicine, Turku University Hospital, POB 52, 20521, Turku, Finland. mijoka@utu.fi.'}, {'ForeName': 'Annalotta', 'Initials': 'A', 'LastName': 'Scheinin', 'Affiliation': 'Department of Perioperative Services, Intensive Care and Pain Medicine, Turku University Hospital, POB 52, 20521, Turku, Finland.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Maksimow', 'Affiliation': 'Medicity Research Laboratory, University of Turku, Turku, Finland.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Långsjö', 'Affiliation': 'Turku PET Centre, University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Kaike', 'Initials': 'K', 'LastName': 'Kaisti', 'Affiliation': 'Turku PET Centre, University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Takala', 'Affiliation': 'Department of Perioperative Services, Intensive Care and Pain Medicine, Turku University Hospital, POB 52, 20521, Turku, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Vahlberg', 'Affiliation': 'Department of Clinical Medicine, Biostatistics, University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Valli', 'Affiliation': 'Department of Psychology and Speech-Language Pathology, and Turku Brain and Mind Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Salmi', 'Affiliation': 'Medicity Research Laboratory, University of Turku, Turku, Finland.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Scheinin', 'Affiliation': 'Department of Perioperative Services, Intensive Care and Pain Medicine, Turku University Hospital, POB 52, 20521, Turku, Finland.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Maksimow', 'Affiliation': 'Department of Perioperative Services, Intensive Care and Pain Medicine, Turku University Hospital, POB 52, 20521, Turku, Finland.'}]",BMC anesthesiology,['10.1186/s12871-019-0895-3']
3164,30567626,Gastrointestinal effects of extra-virgin olive oil associated with lower postprandial glycemia in type 1 diabetes.,"OBJECTIVE


To explore the possible mechanisms behind the lower glycemic response observed when extra-virgin olive oil (EVOO) is added to a high-glycemic index meal in patients with type 1 diabetes (T1D).
RESEARCH DESIGN AND METHODS


According to a randomized cross-over design, eleven T1D patients (6 women, 5 men) on insulin pump consumed in the metabolic ward, one week apart, three high-glycemic index meals differing only for amount and quality of fat: high-monounsaturated fat (EVOO), high-saturated fat (Butter), and low-fat (LF). Before and after the meals, blood glucose (continuous glucose monitoring), gastric emptying rate (ultrasound technique), and plasma concentrations of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide GIP (ELISA), glucagon (RIA), and lipids (colorimetric assays) were evaluated.
RESULTS


Blood glucose iAUC (mmol/lx360 min) was lower after the EVOO (690 ± 431) than after the Butter (1320 ± 600) and LF meals (1007 ± 990) (M ± SD, p = 0.041 by repeated measures ANOVA). Gastric antrum volume was significantly larger in the early (60-90 min) postprandial phase (106 ± 21 vs. 90 ± 16 ml, p = 0.048) and significantly smaller in the late phase (330-360 min) (46 ± 10 vs. 57 ± 22 ml, p = 0.045) after the EVOO than after Butter meal. EVOO significantly increased postprandial GLP-1 iAUC (261 ± 311) compared to Butter (189 ± 349) (pmol/Lx180 min, p = 0.009). Postprandial GIP and glucagon responses were not significantly different between EVOO and Butter. Postprandial triglyceride iAUC was significantly higher after EVOO (100 ± 53) than after Butter (65 ± 60) (mmol/l × 360 min, p = 0.048).
CONCLUSIONS


Changes in gastric emptying and GLP-1 secretion and reduced glucose absorption through glucose-lipid competition may contribute to lower glycemia after a high-glycemic index meal with EVOO in T1D patients.
CLINICAL TRIALS NUMBER


NCT02330939.",2019,Postprandial triglyceride iAUC was significantly higher after EVOO (100 ± 53) than after Butter (65 ± 60) (mmol/,"['10 vs. 57\xa0±', 'type 1 diabetes', 'patients with type 1 diabetes (T1D', 'T1D patients', 'eleven T1D patients (6 women, 5 men) on']","['extra-virgin olive oil (EVOO', 'l', 'insulin pump consumed in the metabolic ward, one week apart, three high-glycemic index meals differing only for amount and quality of fat: high-monounsaturated fat (EVOO), high-saturated fat (Butter), and low-fat (LF', 'extra-virgin olive oil']","['postprandial glycemia', 'postprandial GLP-1 iAUC', 'Blood glucose iAUC', 'Gastric antrum volume', 'Postprandial GIP and glucagon responses', 'Postprandial triglyceride iAUC', 'blood glucose (continuous glucose monitoring), gastric emptying rate (ultrasound technique), and plasma concentrations of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide GIP (ELISA), glucagon (RIA), and lipids (colorimetric assays']","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C2362517', 'cui_str': 'Monounsaturated fat (substance)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0034193', 'cui_str': 'Gastric Antrum'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]",,0.0247706,Postprandial triglyceride iAUC was significantly higher after EVOO (100 ± 53) than after Butter (65 ± 60) (mmol/,"[{'ForeName': 'Lutgarda', 'Initials': 'L', 'LastName': 'Bozzetto', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Alderisio', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Clemente', 'Affiliation': 'Institute for Research on Population and Social Policies (IRPPS), National Research Council, Fisciano, SA, Italy.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Giorgini', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Barone', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Griffo', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Costabile', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Vetrani', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cipriano', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Giacco', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Angela Albarosa', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Annuzzi', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy. Electronic address: annuzzi@unina.it.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.11.015']
3165,32105616,Evaluation of Success of Transport Disc Distraction Osteogenesis and Costochondral Graft for Ramus Condyle Unit Reconstruction in Pediatric Temporomandibular Joint Ankylosis.,"PURPOSE


The costochondral graft (CCG) is considered the reference standard for pediatric temporomandibular joint reconstruction. It has the disadvantages of unpredictable growth, donor site morbidity, and the need for intermaxillary fixation. It has been reported that transport disk distraction osteogenesis (TDDO) can result in the formation of a neocondyle and disc. We performed a randomized trial to measure and compare clinically relevant outcomes of ramus-condyle unit (RCU) reconstruction using CCG and TDDO for pediatric temporomandibular joint ankylosis (TMJA).
MATERIALS AND METHODS


In the present randomized controlled trial (block randomization with a variable block size), pediatric patients with unilateral, nonrecurrent TMJA aged 3 to 16 years who had presented to our unit from December 2015 to June 2017 were enrolled. Instead of temporalis myofascial flap interposition, a buccal fat pad was used to fill the gap created by osteoarthrectomy. The primary outcome parameter was mouth opening. A mouth opening of at least 25 mm at the median follow-up point was considered success. The secondary outcome parameters were occlusion, laterotrusion, protrusion, reankylosis, neocondyle, chin deviation, facial asymmetry, midline shift, and neo-disc formation. Data were analyzed using the independent t test and rank sum test.
RESULTS


A total of 24 patients were enrolled in the CCG and TDDO groups (n = 12 in each group). Trauma (40.9%) was the most common etiology with a slight male preponderance (59.09%). The mean age was 10.32 ± 2.85 years. The average distraction achieved in the TDDO group was 10.42 mm. The median follow-up duration was 31.5 months (range, 24 to 39 months). The mean preoperative maximal incisal opening had improved from 8.5 ± 4.1 and 9.5 ± 7.1 mm in the CCG and TDDO groups preoperatively to 35.7 ± 2.7 and 34.4 ± 8.9 mm, respectively, at the median follow-up point (P < .005). RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed statistically non-significant differences. No reankylosis or open bite was found. The 3-hour delayed gadolinium-enhanced magnetic resonance imaging scan showed successful neo-disc formation.
CONCLUSIONS


Similar success can be achieved in RCU reconstruction using either CCG or TDDO for pediatric TMJA. Both techniques have some advantages and disadvantages. RCU reconstruction using CCG or TDDO results in formation of a neocondyle, maintenance of occlusion, and correction of facial asymmetry.",2020,"RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed nonstatistically significant differences.","['24 patients were enrolled in the CCG and TDDO groups (n\xa0=\xa012 in each group', 'The mean age was 10.32\xa0±\xa02.85\xa0years', 'Pediatric Temporomandibular Joint Ankylosis', 'pediatric patients with unilateral, nonrecurrent TMJA aged 3 to 16\xa0years who had presented to our unit from December 2015 to June 2017 were enrolled']","['transport disk distraction osteogenesis', 'Transport Disc Distraction Osteogenesis and Costochondral Graft', 'ramus-condyle unit (RCU) reconstruction using CCG and TDDO', 'temporalis myofascial flap interposition', 'gadolinium-enhanced magnetic resonance imaging scan']","['mouth opening', 'average distraction', 'mean preoperative maximal incisal opening', 'occlusion, laterotrusion, protrusion, reankylosis, neocondyle, chin deviation, facial asymmetry, midline shift, and neo-disc formation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C2931375', 'cui_str': 'Temporomandibular ankylosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0524975', 'cui_str': 'Osteogenesis, Distraction'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0524414', 'cui_str': 'Condyle'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0039487', 'cui_str': 'Temporal Muscle'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0441633'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C4040028', 'cui_str': 'Incisal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0333056', 'cui_str': 'Protrusion (morphologic abnormality)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C1306710', 'cui_str': 'Facial asymmetry (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",24.0,0.0728373,"RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed nonstatistically significant differences.","[{'ForeName': 'Kamalpreet', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Research Scientist, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Roychoudhury', 'Affiliation': 'Professor and Head, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India. Electronic address: ajoyroy@hotmail.com.'}, {'ForeName': 'Ongkila', 'Initials': 'O', 'LastName': 'Bhutia', 'Affiliation': 'Professor, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashu Seith', 'Initials': 'AS', 'LastName': 'Bhalla', 'Affiliation': 'Professor, Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravinder M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Professor and Head, Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.029']
3166,31929466,The Efficacy of Intensive Short-Term Dynamic Psychotherapy for Social Anxiety Disorder: Randomized Trial and Substudy of Emphasizing Feeling Versus Defense Work.,"This research examined the efficacy of intensive short-term dynamic psychotherapy (ISTDP) in the treatment of social anxiety disorder (SAD) and compared the therapeutic outcomes of ISTDP when feeling focus or defense work is emphasized. A three-group randomized design with 6-month follow-up was used. Forty-one subjects were selected among volunteer college students diagnosed with SAD. They were assigned randomly into three groups; 14 cases to feeling-focused ISTDP (FF-ISTDP) group, 14 cases to defense-focused ISTDP (DF-ISTDP) group, and 13 cases to a control group. All subjects were evaluated at pretest, posttest, and six-month follow-up through clinical interviewing using DSM-5 criteria for SAD along with the Liebowitz Social Anxiety Scale. Each experimental group had a course of 8 to 10 sessions of ISTDP treatment. Analysis of variance showed that ISTDP is an effective treatment for SAD compared with a control group. No outcome differences were found between FF-ISTDP and DF-ISTDP in treating SAD.",2020,This research examined the efficacy of intensive short-term dynamic psychotherapy (ISTDP) in the treatment of social anxiety disorder (SAD) and compared the therapeutic outcomes of ISTDP when feeling focus or defense work is emphasized.,"['Social Anxiety Disorder', 'Forty-one subjects were selected among volunteer college students diagnosed with SAD', 'social anxiety disorder (SAD']","['Intensive Short-Term Dynamic Psychotherapy', 'ISTDP', 'feeling-focused ISTDP (FF-ISTDP) group, 14 cases to defense-focused ISTDP (DF-ISTDP', 'intensive short-term dynamic psychotherapy (ISTDP']",['FF-ISTDP and DF-ISTDP'],"[{'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",[],41.0,0.0152694,This research examined the efficacy of intensive short-term dynamic psychotherapy (ISTDP) in the treatment of social anxiety disorder (SAD) and compared the therapeutic outcomes of ISTDP when feeling focus or defense work is emphasized.,"[{'ForeName': 'Fateh', 'Initials': 'F', 'LastName': 'Rahmani', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbass', 'Affiliation': 'Centre for Emotions and Health, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Azad', 'Initials': 'A', 'LastName': 'Hemmati', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Sahar Rezaei', 'Initials': 'SR', 'LastName': 'Mirghaed', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Ghaffari', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001097']
3167,31383945,Umbilical venous catheter insertion depth estimation using birth weight versus surface measurement formula: a randomized controlled trial.,"OBJECTIVE


To determine if umbilical venous catheter (UVC) insertion depth estimated by surface measurement (SM) results in optimal catheter tip position on ultrasound as compared with formula using birth weight (BW).
METHODS


In this randomized controlled trial, eligible infants were randomized to UVC insertion depth estimated by SM or BW method. We compared proportion of optimum UVC position on ultrasound read by neonatologist masked with group assignment.
RESULTS


UVC was inserted to estimated depth in 164 of 200 enroled infants. There was no difference in the proportion of correctly positioned UVCs between the groups (SM 33/82 (40.2%) vs BW 27/82 (32.9%), p = 0.33). Among BW < 1000 g, SM method had higher correctly positioned UVC (43.7% vs 22.5%, p = 0.07).
CONCLUSION


There was no difference in the rate of optimally positioned UVC tip between the two methods for estimating UVC insertion depth. However, SM method results in more optimal positioning of UVC tip among BW < 1000 g infants.",2020,There was no difference in the rate of optimally positioned UVC tip between the two methods for estimating UVC insertion depth.,"['164 of 200 enroled infants', 'eligible infants']","['Umbilical venous catheter insertion depth estimation using birth weight versus surface measurement formula', 'umbilical venous catheter (UVC) insertion depth estimated by surface measurement (SM']","['rate of optimally positioned UVC tip', 'proportion of correctly positioned UVCs', 'correctly positioned UVC']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0745442', 'cui_str': 'Venous catheter (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]","[{'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]",,0.218732,There was no difference in the rate of optimally positioned UVC tip between the two methods for estimating UVC insertion depth.,"[{'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Sheta', 'Affiliation': 'Department of Pediatrics, Section of Neonatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Majeeda', 'Initials': 'M', 'LastName': 'Kamaluddeen', 'Affiliation': 'Department of Pediatrics, Section of Neonatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Amuchou Singh', 'Initials': 'AS', 'LastName': 'Soraisham', 'Affiliation': 'Department of Pediatrics, Section of Neonatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. asoraish@ucalgary.ca.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0456-0']
3168,31809394,"Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the Treatment of Bone Defects in Tibial Plateau Fractures: A Prospective, Randomized, Open-Label, Multicenter Study.","BACKGROUND


Bone-graft substitutes are commonly used for the augmentation of traumatic bone defects in tibial plateau fractures. However, their clinical performance compared with that of autologous bone-grafting, the gold standard in bone defect reconstruction, still remains under debate. This study investigates the differences in quality of life, pain, and radiographic outcomes in the treatment of tibial plateau fracture-associated bone defects with either autologous bone grafts or a bioresorbable hydroxyapatite and calcium sulfate cement (CERAMENT BONE VOID FILLER [CBVF]; BONESUPPORT).
METHODS


In this study, 135 patients with acute depression and split-depression fractures of the proximal part of the tibia (OTA/AO types 41-B2 and 41-B3) were enrolled in a prospective, controlled, randomized, multicenter trial including 20 hospitals in Germany. Patients were randomized to receive either autologous iliac bone graft or CBVF for reconstruction of the bone defect. The primary outcome measures were the Short Form (SF)-12 version 2 Physical Component Summary (PCS) score at week 26 (the study was designed to show noninferiority of the CBVF with regard to the PCS with a prespecified margin of -5 points) and the pain level at 26 weeks postoperatively measured by a visual analog scale (VAS). The secondary outcomes were the SF-12 version 2 Mental Component Summary (MCS) and SF-12 PCS scores at weeks 1, 6, and 12 and bone-healing on radiographs.
RESULTS


Age, sex, fixation methods, and fracture pattern were comparable in both groups. There were no significant differences (p > 0.05) in the SF-12 PCS or VAS scores at postoperative week 26. There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group. The rates of fracture-healing, defect remodeling, and articular subsidence were not significantly different (p > 0.05) in both groups.
CONCLUSIONS


Bioresorbable CBVF was noninferior to autologous bone graft with regard to both patient-reported and radiographic outcomes in tibial plateau fractures of OTA/AO types 41-B2 and 41-B3.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group.,"['tibial plateau fractures', '135 patients with acute depression and split-depression fractures of the proximal part of the tibia (OTA/AO types 41-B2 and 41-B3', '20 hospitals in Germany', 'Tibial Plateau Fractures']","['Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement', 'autologous bone-grafting', 'autologous iliac bone graft or CBVF', 'autologous bone grafts or a bioresorbable hydroxyapatite and calcium sulfate cement (CERAMENT BONE VOID FILLER [CBVF]; BONESUPPORT']","['rates of fracture-healing, defect remodeling, and articular subsidence', 'SF-12 PCS or VAS scores', 'Bone Defects', 'pain level', 'quality of life, pain, and radiographic outcomes', 'Short Form (SF)-12 version 2 Physical Component Summary (PCS) score', 'SF-12 version 2 Mental Component Summary (MCS) and SF-12 PCS scores at weeks 1, 6, and 12 and bone-healing on radiographs', 'visual analog scale (VAS', 'blood loss', 'pain levels']","[{'cui': 'C0584640', 'cui_str': 'Tibial plateau structure (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1386135', 'cui_str': 'Acute depression'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0181075', 'cui_str': 'Bone graft material (product)'}, {'cui': 'C0205184', 'cui_str': 'Biphasic (qualifier value)'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0006720', 'cui_str': 'Calcium Sulfate'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}, {'cui': 'C3658778', 'cui_str': 'cerament'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}]","[{'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",135.0,0.067637,There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hofmann', 'Affiliation': 'Department of Traumatology and Orthopaedics 1, Academic Teaching Hospital of the Universities Mainz and Heidelberg, Westpfalz-Clinics, Kaiserslautern, Germany.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Gorbulev', 'Affiliation': 'Interdisciplinary Center for Clinical Trials (IZKS), University Medical Center, Mainz, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Guehring', 'Affiliation': 'Department for Traumatology and Orthopaedic Surgery, BG Traumacenter Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Arndt Peter', 'Initials': 'AP', 'LastName': 'Schulz', 'Affiliation': 'Department of Traumatology, Orthopaedics and Sports Traumatology, BG Trauma Hospital, Hamburg, Germany.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Schupfner', 'Affiliation': 'Department of Trauma Surgery, Clinical Center Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Raschke', 'Affiliation': 'Department of Trauma Surgery, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Huber-Wagner', 'Affiliation': 'Department of Trauma Surgery, University of Munich, Munich, Germany.'}, {'ForeName': 'Pol Maria', 'Initials': 'PM', 'LastName': 'Rommens', 'Affiliation': 'Department of Orthopedics and Traumatology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00680']
3169,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE


To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS


There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION


The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
3170,31699052,Transversus abdominis plane block with general anesthesia blunts the perioperative stress response in patients undergoing radical gastrectomy.,"BACKGROUND


Surgical stress induces the release of neuroendocrine mediators and cytokines during perioperative period, which may have adverse effects on cancer patients. While the surgical stress responsse can be affected by anesthetic technique. Therefore, we designed this study to assess whether subcostal transversus abdominis plane (TAP) block can affect perioperative neuroendocrine stress response, postoperative analgesia and postoperative recovery in patients undergoing radical gastrectomy under general anesthesia.
METHODS


Sixty-five patients were recruited. Patients randomly received general anesthesia (control group), or general anesthesia combined with TAP block (40 mL of 0.375% ropivacaine) (TAP group). The primary outcome was neuroendocrine levels including norepinephrine (NE), epinephrine (E), cortisol (Cor), glucose (Glu), interleukin (IL)-6 and IL-10 during 48 h after surgery. Secondary outcomes included pain score, hemodynamic variables and recovery characteristics.
RESULTS


Data from 61 of 65 patients were analyzed. The levels of NE, E, Cor, and Glu were blunt by TAP block during perioperative period. The levels of IL-6 and IL-10 were significantly lower in TAP group than in control group. TAP block efficiently relieved postoperative acute pain up to 12 h postoperatively with more stable perioperative hemodynamics compared with control group.
CONCLUSIONS


Subcostal TAP block blunts perioperative stress response and provides efficient analgesia, with good hemodynamic stability and minimal adverse effects.",2019,"TAP block efficiently relieved postoperative acute pain up to 12 h postoperatively with more stable perioperative hemodynamics compared with control group.
","['patients undergoing radical gastrectomy', 'Data from 61 of 65 patients were analyzed', 'patients undergoing radical gastrectomy under general anesthesia', 'cancer patients', 'Sixty-five patients were recruited']","['TAP block', 'general anesthesia (control group), or general anesthesia combined with TAP block (40\u2009mL of 0.375% ropivacaine', 'subcostal transversus abdominis plane (TAP) block', 'Transversus abdominis plane block with general anesthesia', 'Subcostal TAP block', 'TAP']","['postoperative acute pain', 'perioperative stress response', 'pain score, hemodynamic variables and recovery characteristics', 'neuroendocrine levels including norepinephrine (NE), epinephrine (E), cortisol (Cor), glucose (Glu), interleukin (IL)-6 and IL-10 during 48\u2009h after surgery', 'IL-6 and IL-10', 'levels of NE, E, Cor, and Glu']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0565313', 'cui_str': 'Radical gastrectomy (procedure)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}]","[{'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4517455', 'cui_str': '0.375 (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0442184', 'cui_str': 'Subcostal (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0061055', 'cui_str': 'Glu-(Abu)'}]",65.0,0.114607,"TAP block efficiently relieved postoperative acute pain up to 12 h postoperatively with more stable perioperative hemodynamics compared with control group.
","[{'ForeName': 'Ruizhu', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, China-Japan Union Hospital of Jilin University, No. 126 Xiantai Road, Changchun, 130000, Jilin Province, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Department of Plastic Surgery, China-Japan Union Hospital of Jilin University, Changchun, 130000, Jilin Province, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, No. 965 Hospital of PLA, Jilin, 132000, Jilin Province, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, China-Japan Union Hospital of Jilin University, No. 126 Xiantai Road, Changchun, 130000, Jilin Province, China. likai82@126.com.'}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, China-Japan Union Hospital of Jilin University, No. 126 Xiantai Road, Changchun, 130000, Jilin Province, China. zhaogq65@126.com.'}]",BMC anesthesiology,['10.1186/s12871-019-0861-0']
3171,32088913,Clinical Effectiveness of Levetiracetam Compared to Fosphenytoin in the Treatment of Benzodiazepine Refractory Convulsive Status Epilepticus.,"OBJECTIVES


To determine whether levetiracetam is an alternative to fosphenytoin to control Benzodiazepine Refractory Status Epilepticus (BRSE) in pediatric population and also to compare the acute drug related side-effects and ventilation requirement among the both arms of anti-epileptic drug therapy.
METHODS


All consecutive children admitted with BRSE were randomized to group A, who received fosphenytoin at 20 mg/kg phenytoin equivalents (PE) dose and group B who received levetiracetam at 40 mg/kg over 10 min. Time to terminate seizure (response latency) was measured. If seizure remained refractory after 20 min of test drug administration, appropriate drug escalation was made according to pediatrician's discretion. All primary and secondary outcome measures were compared between the two therapeutic groups.
RESULTS


Of 61 children enrolled over 18 mo period, 29 (47.5%) were randomized to group A and 32 (52.5%) were randomized to Group B. Baseline characteristics were comparable between the two groups. Among 61 children, 58(98%) required Pediatric Intensive Care Unit (PICU) admission and among those 5(8.2%) children required mechanical ventilation. Duration of PICU stay, hospital stay, the response latency and seizure recurrence were compared between both groups. Significant number of children received additional anti-epileptic drugs (AEDs) in fosphenytoin group [9/29(31%)] compared to levetiracetam group [2/32(7%)] to control seizure.
CONCLUSIONS


Levetiracetam may be an effective alternative to fosphenytoin in management of BRSE in children but multicentric trials with large sample size are needed to substantiate this observation.",2020,"CONCLUSIONS


Levetiracetam may be an effective alternative to fosphenytoin in management of BRSE in children but multicentric trials with large sample size are needed to substantiate this observation.","['All consecutive children admitted with BRSE', '61 children, 58(98%) required Pediatric Intensive Care Unit (PICU) admission and among those 5(8.2%) children required mechanical ventilation', 'Benzodiazepine Refractory Convulsive Status Epilepticus', '61 children enrolled over 18 mo period, 29 (47.5%) were randomized to group A and 32 (52.5']","['levetiracetam', 'Levetiracetam', 'fosphenytoin at 20\xa0mg/kg phenytoin equivalents (PE) dose and group B who received levetiracetam at 40\xa0mg/kg over 10\xa0min', 'Fosphenytoin']","['Duration of PICU stay, hospital stay, the response latency and seizure recurrence', 'Time to terminate seizure (response latency']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C3536587', 'cui_str': 'Convulsive status epilepticus, refractory'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",61.0,0.169166,"CONCLUSIONS


Levetiracetam may be an effective alternative to fosphenytoin in management of BRSE in children but multicentric trials with large sample size are needed to substantiate this observation.","[{'ForeName': 'Sricharantheja', 'Initials': 'S', 'LastName': 'Nalisetty', 'Affiliation': 'Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sasidaran', 'Initials': 'S', 'LastName': 'Kandasamy', 'Affiliation': 'Advanced Pediatric Critical Care Center, Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, 600031, India. sasidarpgi@gmail.com.'}, {'ForeName': 'Balaji', 'Initials': 'B', 'LastName': 'Sridharan', 'Affiliation': 'Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Vimalraj', 'Initials': 'V', 'LastName': 'Vijayakumar', 'Affiliation': 'Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Thangavelu', 'Initials': 'T', 'LastName': 'Sangaralingam', 'Affiliation': 'Department of Pediatrics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Nedunchelian', 'Initials': 'N', 'LastName': 'Krishnamoorthi', 'Affiliation': 'Department of Research & Academics, Mehta Multi-speciality Hospitals, Chennai, Tamil Nadu, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03221-2']
3172,32108254,Local osteo-enhancement of osteoporotic vertebra with a triphasic bone implant material increases strength-a biomechanical study.,"PURPOSE


The aim of this study was to assess the biomechanical properties of intact vertebra augmented using a local osteo-enhancement procedure to inject a triphasic calcium sulfate/calcium phosphate implant material.
METHODS


Twenty-one fresh frozen human cadaver vertebra (Th11-L2) were randomized into three groups: treatment, sham, and control (n = 7 each). Treatment included vertebral body access, saline lavage to displace soft tissue and marrow elements, and injection of the implant material to fill approximately 20% of the vertebral body by volume. The sham group included all treatment steps, but without injection of the implant material. The control group consisted of untreated intact osteoporotic vertebra. Load at failure and displacement at failure for each of the three groups were measured in axial compression loading.
RESULTS


The mean failure load of treated vertebra (4118 N) was significantly higher than either control (2841 N) or sham (2186 N) vertebra (p < 0.05 for: treatment vs. control, treatment vs. sham). Treated vertebra (1.11 mm) showed a significantly higher mean displacement at failure than sham vertebra (0.80 mm) (p < 0.05 for: treatment vs. sham). In the control group, the mean displacement at failure was 0.99 mm.
CONCLUSIONS


This biomechanical study shows that a local osteo-enhancement procedure using a triphasic implant material significantly increases the load at failure and displacement at failure in cadaveric osteoporotic vertebra.",2020,"The mean failure load of treated vertebra (4118 N) was significantly higher than either control (2841 N) or sham (2186 N) vertebra (p < 0.05 for: treatment vs. control, treatment vs. sham).","['Twenty-one fresh frozen human cadaver vertebra (Th11-L2', 'cadaveric osteoporotic vertebra']","['triphasic calcium sulfate/calcium phosphate implant material', 'triphasic bone implant material', 'untreated intact osteoporotic vertebra']","['mean failure load of treated vertebra', 'vertebral body access, saline lavage to displace soft tissue and marrow elements, and injection of the implant material', 'mean displacement at failure']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0006629', 'cui_str': 'Corpse'}, {'cui': 'C0549207', 'cui_str': 'Vertebra'}]","[{'cui': 'C0205185', 'cui_str': 'Triphasic (qualifier value)'}, {'cui': 'C0006720', 'cui_str': 'Calcium Sulfate'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0440216', 'cui_str': 'Implant material (substance)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0549207', 'cui_str': 'Vertebra'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0549207', 'cui_str': 'Vertebra'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0440216', 'cui_str': 'Implant material (substance)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}]",21.0,0.0382321,"The mean failure load of treated vertebra (4118 N) was significantly higher than either control (2841 N) or sham (2186 N) vertebra (p < 0.05 for: treatment vs. control, treatment vs. sham).","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Trost', 'Affiliation': 'Department of Orthopaedics and Traumatology, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schmoelz', 'Affiliation': 'Department of Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria. werner.schmoelz@i-med.ac.at.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Wimmer', 'Affiliation': 'Department of Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Romed', 'Initials': 'R', 'LastName': 'Hörmann', 'Affiliation': 'Division of Clinical and Functional Anatomy, Department of Anatomy, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Sönke', 'Initials': 'S', 'LastName': 'Frey', 'Affiliation': 'Department of Orthopaedics and Traumatology, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Tobias Ludger', 'Initials': 'TL', 'LastName': 'Schulte', 'Affiliation': 'Department of Orthopaedics and Traumatology, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03382-x']
3173,32107736,Cost-Effectiveness Analysis of Supervised Exercise Training in Men with Prostate Cancer Previously Treated with Radiation Therapy and Androgen-Deprivation Therapy.,"BACKGROUND


Exercise for prostate cancer (PCa) survivors has been shown to be effective in addressing metabolic function and associated co-morbidities, as well as sarcopenia and significant functional impairment resulting from long-term androgen deprivation. Evidence on the cost-effectiveness of exercise interventions for PCa, however, is lacking, thus the aim of this study was to determine the cost-effectiveness of a supervised exercise intervention for long-term PCa survivors who previously received radiation therapy and androgen-deprivation therapy.
METHODS


Cost-effectiveness analysis from an Australian healthcare-payer perspective was conducted using patient-level data from a multicentre randomised controlled trial (RCT) of supervised exercise training (resistance and aerobic) compared to receiving printed exercise material and a recommendation to exercise in long-term PCa survivors (> 5 years post-diagnosis). Analysis was undertaken for the 6-month supervised exercise portion of the intervention, which involved 100 men aged between 62 and 85 years, 50 in each arm. The primary outcome was cost per quality-adjusted life-years (QALYs).
RESULTS


A 6-month supervised exercise intervention for PCa survivors resulted in an incremental cost-effectiveness ratio of AU$64,235 (2018 AUD) at an incremental cost of AU$546 per person and a QALY gain of 0.0085. At a willingness-to-pay of AU$50,000, the probability that the intervention is cost-effective was 41%. Sensitivity analysis showed that maintenance of benefits via a 6-month home-based intervention, immediately following the supervised intervention, lowered the cost per QALY gained to AU$32,051.
DISCUSSION


This is the first cost-effectiveness analysis of exercise for PCa survivors. The intervention was effective, but unlikely to be cost-effective at the generally accepted willingness-to-pay of AU$50,000 per QALY. It is likely that evidence to support cost savings from post-intervention outcomes would reveal greater benefits and contribute to a more comprehensive cost-effectiveness analysis. Future RCTs should incorporate longer follow-up durations and collection of data to support modelling to capture future health benefits. Measures of quality of life or utility more sensitive to the impact of physical activity would also improve future economic evaluations.",2020,"The intervention was effective, but unlikely to be cost-effective at the generally accepted willingness-to-pay of AU$50,000 per QALY.","['100 men aged between 62 and 85\xa0years, 50 in each arm', 'in long-term PCa survivors (>\u20095\xa0years post-diagnosis', 'Men with Prostate Cancer', 'prostate cancer (PCa) survivors']","['supervised exercise training (resistance and aerobic) compared to receiving printed exercise material and a recommendation to exercise', 'supervised exercise intervention', 'Supervised Exercise Training', 'radiation therapy and androgen-deprivation therapy', 'Radiation Therapy and Androgen-Deprivation Therapy']","['cost-effectiveness', 'cost per quality-adjusted life-years (QALYs', 'incremental cost-effectiveness ratio of AU$64,235 (2018 AUD']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0418878', 'cui_str': 'Advice to exercise'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",100.0,0.0779652,"The intervention was effective, but unlikely to be cost-effective at the generally accepted willingness-to-pay of AU$50,000 per QALY.","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Edmunds', 'Affiliation': 'Centre for Applied Health Economics, Griffith University, Nathan, QLD, Australia. k.edmunds@griffith.edu.au.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Reeves', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Scuffham', 'Affiliation': 'Centre for Applied Health Economics, Griffith University, Nathan, QLD, Australia.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Galvão', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Spry', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Taaffe', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Suzanne K', 'Initials': 'SK', 'LastName': 'Chambers', 'Affiliation': 'Faculty of Health, University of Technology, Sydney, NSW, Australia.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Tuffaha', 'Affiliation': 'Centre for Applied Health Economics, Griffith University, Nathan, QLD, Australia.'}]",Applied health economics and health policy,['10.1007/s40258-020-00564-x']
3174,32100168,The Effect of Spiritual Care Based on the Sound Heart Model on the Spiritual Health of Patients with Acute Myocardial Infarction.,"Meeting the spiritual needs of patients with cardiovascular diseases has a significant effect on their speed of recovery and spiritual health, especially in coronary care units (CCUs). The present study was conducted to investigate the effect of spiritual care based on the sound heart model on the spiritual health of patients with acute myocardial infarction (AMI) admitted to the CCU of Chamran Hospital in Isfahan, Iran, in 2016. This clinical trial was conducted on 92 patients with AMI selected by convenience sampling and randomly assigned to the intervention (n = 46) and control (n = 46) groups. The spiritual care program based on the sound heart model was regularly carried out for the intervention group over 3 days at 5-8 PM during their hospital stay, and continued for 1 month at home after discharge from the hospital, and the control group only received routine nursing interventions. The patients completed Paloutzian and Ellison's Spiritual Well-Being Scale at baseline and a month after the intervention. Data were ultimately analyzed using Fisher's exact test, Mann-Whitney's test, the Chi-square test, and the t test. The spiritual care program was able to improve the mean scores of religious health (7.8), existential health (9.3) and the total score of spiritual health (17.1) in the intervention group, while these scores reduced to 0.9, 3.4 and 4.2 in the control group. A significant difference was found between the intervention and control groups in terms of the spiritual health score (P < 0.001). The present findings confirmed the effect of spiritual care based on the sound heart model on promoting spiritual health in patients with AMI. Its application as a holistic care approach is therefore recommended for improving the signs and dimensions of spiritual health in patients with coronary artery disease, especially MI.",2020,"The spiritual care program was able to improve the mean scores of religious health (7.8), existential health (9.3) and the total score of spiritual health (17.1) in the intervention group, while these scores reduced to 0.9, 3.4 and 4.2 in the control group.","['patients with acute myocardial infarction (AMI) admitted to the CCU of Chamran Hospital in Isfahan, Iran, in 2016', 'patients with AMI', '92 patients with AMI selected by convenience sampling and randomly assigned to the intervention (n\u2009=\u200946) and control (n\u2009=\u200946) groups', 'Patients with Acute Myocardial Infarction', 'patients with cardiovascular diseases', 'patients with coronary artery disease, especially MI']","['Spiritual Care Based on the Sound Heart Model', 'routine nursing interventions', 'spiritual care based on the sound heart model']","['spiritual health score', 'mean scores of religious health (7.8), existential health (9.3) and the total score of spiritual health']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0150355', 'cui_str': 'Spiritual support'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}]","[{'cui': 'C0686997', 'cui_str': 'Spiritual health'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",92.0,0.0163883,"The spiritual care program was able to improve the mean scores of religious health (7.8), existential health (9.3) and the total score of spiritual health (17.1) in the intervention group, while these scores reduced to 0.9, 3.4 and 4.2 in the control group.","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Babamohamadi', 'Affiliation': 'Nursing Care Research Center, Semnan University of Medical Sciences, 5 Kilometer of Damghan Road, Educational and Research Campus, Semnan, 3513138111, Iran.'}, {'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Kadkhodaei-Elyaderani', 'Affiliation': 'Student Research Committee, Semnan University of Medical Sciences, 5 Kilometer of Damghan Road, Educational and Research Campus, Semnan, 3513138111, Iran.'}, {'ForeName': 'Abbasali', 'Initials': 'A', 'LastName': 'Ebrahimian', 'Affiliation': 'Nursing Care Research Center, Semnan University of Medical Sciences, 5 Kilometer of Damghan Road, Educational and Research Campus, Semnan, 3513138111, Iran. aa.ebrahimian@semums.ac.ir.'}, {'ForeName': 'Raheb', 'Initials': 'R', 'LastName': 'Ghorbani', 'Affiliation': 'Social Determinants of Health Research Center, Semnan University of Medical Sciences, 5 Kilometer of Damghan Road, Educational and Research Campus, Semnan, 3513138111, Iran.'}]",Journal of religion and health,['10.1007/s10943-020-01003-w']
3175,3905070,Cefoxitin single dose prophylaxis and/or T tube suction drainage for vaginal and abdominal hysterectomy (Prospective randomized trial on 155 patients).,"Pelvic infections represent the most feared complications associated with vaginal and abdominal hysterectomy. In the present paper we show result of a prospective randomized clinical trial carried out to study different morbidities (F.M. febrile morbidity, U.T.I. urinary tract infections, P.C. pelvic cellulitis, P.A. pelvic abscess, W.I. wound infection) in a sample of 155 patients undergoing vaginal or abdominal hysterectomy for non malignant disease, divided into three groups. group C, treated with 2 g cefoxitin i.v. in the preoperative period; group C+T, the same treatment with the addition of T tube suction drainage; group T, with only the T tube suction drainage. A statistical analysis of the sample showed the homogeneity of each group, while the study of the morbidities showed a statistical significant difference for W.I. between the groups treated with antibiotic and the T group (p less than .001). For all the other morbidities, no statistically significant differences were found between the groups, demonstrating that all three methods are considerably efficient in reducing postoperative morbidity in hysterectomy.",1985,"For all the other morbidities, no statistically significant differences were found between the groups, demonstrating that all three methods are considerably efficient in reducing postoperative morbidity in hysterectomy.","['155 patients', '155 patients undergoing vaginal or abdominal hysterectomy for non malignant disease, divided into three groups', 'vaginal and abdominal hysterectomy']","['cefoxitin i.v', 'Cefoxitin single dose prophylaxis and/or T tube suction drainage']",['postoperative morbidity'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy (procedure)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0007557', 'cui_str': 'Cefoxitin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0175731', 'cui_str': 'T-tube, device (physical object)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",155.0,0.0378464,"For all the other morbidities, no statistically significant differences were found between the groups, demonstrating that all three methods are considerably efficient in reducing postoperative morbidity in hysterectomy.","[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Scotto', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sbiroli', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
3176,32107560,Attainment of treat-to-target endpoints in SLE patients with high disease activity in the atacicept phase 2b ADDRESS II study.,"OBJECTIVE


Low disease activity (LDA) and remission are emerging treat-to-target (T2T) endpoints in SLE. However, the rates at which these endpoints are met in patients with high disease activity (HDA) are unknown. Atacicept, which targets B lymphocyte stimulator and a proliferation-inducing ligand, improved disease outcomes in SLE patients with HDA (SLEDAI-2K ≥10) at baseline in the phase 2b ADDRESS II study. This is a post hoc analysis of T2T endpoints in these patients.
METHODS


Patients received weekly atacicept (75 or 150 mg s.c.) or placebo for 24 weeks (1:1:1 randomization). Attainment of three T2T endpoints, LDA (SLEDAI-2K ≤ 2), Lupus Low Disease Activity State (LLDAS) and remission (clinical SLEDAI-2K = 0, prednisone-equivalent ≤5mg/day and Physician's Global Assessment <0.5), was assessed and compared with SLE Responder Index (SRI)-4 and SRI-6 response.
RESULTS


Of 306 randomized patients, 158 (51.6%) had baseline HDA. At week 24, 37 (23.4%) HDA patients attained LDA, 25 (15.8%) LLDAS and 17 (10.8%) remission. Each of these endpoints was more stringent than SRI-4 (n = 87; 55.1%) and SRI-6 (n = 67; 42.4%). Compared with placebo (n = 52), at week 24, patients treated with atacicept 150 mg (n = 51) were more likely to attain LDA [odds ratio (OR) 3.82 (95% CI: 1.44, 10.15), P = 0.007], LLDAS [OR 5.03 (95% CI: 1.32, 19.06), P = 0.018] or remission [OR 3.98 (95% CI: 0.78, 20.15), P = 0.095].
CONCLUSION


At week 24, LDA, LLDAS and remission were more stringent than SRI-4 and SRI-6 response, were attainable in the HDA population and discriminated between treatment with atacicept 150 mg and placebo. These results suggest that T2T endpoints are robust outcome measures in SLE clinical trials and support further evaluation of atacicept in SLE.
TRAIL REGISTRATION


ClinicalTrials.gov, http://clinicaltrials.gov, NCT01972568.",2020,"At week 24, LDA, LLDAS and remission were more stringent than SRI-4 and SRI-6 response, were attainable in the HDA population and discriminated between treatment with atacicept 150 mg and placebo.","['SLE patients with HDA (SLEDAI-2K ≥10', 'SLE patients with high disease activity in the atacicept phase 2b ADDRESS II study', 'patients with high disease activity (HDA', 'Of 306 randomized patients, 158 (51.6%) had baseline HDA']","['placebo', 'atacicept']","['SLE Responder Index (SRI)-4 and SRI-6 response', 'LDA, LLDAS and remission', 'LDA (SLEDAI-2K ≤\u20092), Lupus Low Disease Activity State (LLDAS) and remission']","[{'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2351058', 'cui_str': 'Atacicept'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2351058', 'cui_str': 'Atacicept'}]","[{'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",306.0,0.238022,"At week 24, LDA, LLDAS and remission were more stringent than SRI-4 and SRI-6 response, were attainable in the HDA population and discriminated between treatment with atacicept 150 mg and placebo.","[{'ForeName': 'Eric F', 'Initials': 'EF', 'LastName': 'Morand', 'Affiliation': 'Centre for Inflammatory Disease, Monash University, Melbourne, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Isenberg', 'Affiliation': 'Centre for Rheumatology, University College London, London, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wallace', 'Affiliation': 'Division of Rheumatology, Cedars-Sinai Medical Center, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Amy H', 'Initials': 'AH', 'LastName': 'Kao', 'Affiliation': 'EMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vazquez-Mateo', 'Affiliation': 'EMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chang', 'Affiliation': 'EMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.'}, {'ForeName': 'Kishore', 'Initials': 'K', 'LastName': 'Pudota', 'Affiliation': 'EMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Aranow', 'Affiliation': 'Institute of Molecular Medicine, Feinstein Institute for Medical Research, Manhasset, NY, USA.'}, {'ForeName': 'Joan T', 'Initials': 'JT', 'LastName': 'Merrill', 'Affiliation': 'Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa029']
3177,31945929,Does repetitive Transcranial Magnetic Stimulation (rTMS) have therapeutic effects on Dynamic Balance of Children with Cerebral Palsy?,"Our big goal in this research was to evaluate the therapeutic effects of repetitive Transcranial Magnetic Stimulation (rTMS) on cerebral palsy (CP) children with balance deficits. Four spastic hemiplegic CP children were participated; the experimental group received rTMS training 4 days a week for 3 weeks and then for the next 3 weeks they received typical occupational therapy just after rTMS therapy. The control group received placebo rTMS instead of real one accordingly. Their dynamic balance was evaluated before the start of the treatment and 6 weeks after it. Center of pressure (COP) and center of mass (COM) features were regarded as dynamic balance parameters. Our results showed that the peak to peak of COP, COM, COM-COP, COM-COP inclination angles all improved for both experimental (15-86%) and control group patients, though there was less improvement about 8-46% in features of the control patients. Our results demonstrate that intensive sessions of the rTMS training could have the potential to enhance the therapeutic effects of typical occupational therapy that can produce dynamic balance improvements in CP children compared to using the occupational therapy by itself.",2019,"Our results showed that the peak to peak of COP, COM, COM-COP, COM-COP inclination angles all improved for both experimental (15-86%) and control group patients, though there was less improvement about 8-46% in features of the control patients.","['cerebral palsy (CP) children with balance deficits', 'Children with Cerebral Palsy', 'Four spastic hemiplegic CP children', 'CP children']","['typical occupational therapy just after rTMS therapy', 'repetitive Transcranial Magnetic Stimulation (rTMS', 'rTMS training', 'placebo rTMS']","['Center of pressure (COP) and center of mass (COM) features', 'peak to peak of COP, COM, COM-COP, COM-COP inclination angles']","[{'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0443306', 'cui_str': 'Spastic'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]",,0.0114372,"Our results showed that the peak to peak of COP, COM, COM-COP, COM-COP inclination angles all improved for both experimental (15-86%) and control group patients, though there was less improvement about 8-46% in features of the control patients.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dadashi', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lotfian', 'Affiliation': ''}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Rafieenazari', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shahroki', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Irani', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirbagheri', 'Affiliation': ''}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Mirbagheri', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2019.8857947']
3178,31233639,Bone-Forming and Antiresorptive Effects of Romosozumab in Postmenopausal Women With Osteoporosis: Bone Histomorphometry and Microcomputed Tomography Analysis After 2 and 12 Months of Treatment.,"Sclerostin, a protein produced by osteocytes, inhibits bone formation. Administration of sclerostin antibody results in increased bone formation in multiple animal models. Romosozumab, a humanized sclerostin antibody, has a dual effect on bone, transiently increasing serum biochemical markers of bone formation and decreasing serum markers of bone resorption, leading to increased BMD and reduction in fracture risk in humans. We aimed to evaluate the effects of romosozumab on bone tissue. In a subset of 107 postmenopausal women with osteoporosis in the multicenter, international, randomized, double-blind, placebo-controlled Fracture Study in Postmenopausal Women with Osteoporosis (FRAME), transiliac bone biopsies were performed either after 2 (n = 34) or 12 (n = 73) months of treatment with 210 mg once monthly of romosozumab or placebo to evaluate histomorphometry and microcomputed tomography-based microarchitectural endpoints. After 2 months, compared with either baseline values assessed after a quadruple fluorochrome labeling or placebo, significant increases (P < 0.05 to P < 0.001) in dynamic parameters of formation (median MS/BS: romosozumab 1.51% and 5.64%; placebo 1.60% and 2.31% at baseline and month 2, respectively) were associated with a significant decrease compared with placebo in parameters of resorption in cancellous (median ES/BS: placebo 3.4%, romosozumab 1.8%; P = 0.022) and endocortical (median ES/BS: placebo 6.3%, romosozumab 1.6%; P = 0.003) bone. At 12 months, cancellous bone formation was significantly lower (P < 0.05 to P < 0.001) in romosozumab versus placebo and the lower values for resorption endpoints seen at month 2 persisted (P < 0.001), signaling a decrease in bone turnover (P = 0.006). No significant change was observed in periosteal and endocortical bone. This resulted in an increase in bone mass and trabecular thickness with improved trabecular connectivity, without significant modification of cortical porosity at month 12. In conclusion, romosozumab produced an early and transient increase in bone formation, but a persistent decrease in bone resorption. Antiresorptive action eventually resulted in decreased bone turnover. This effect resulted in significant increases in bone mass and improved microarchitecture. © 2019 American Society for Bone and Mineral Research.",2019,"At 12 months, cancellous bone formation was significantly lower (P < 0.05 to P < 0.001) in romosozumab versus placebo and the lower values for resorption endpoints seen at month 2 persisted (P < 0.001), signaling a decrease in bone turnover (P = 0.006).","['Postmenopausal Women With Osteoporosis', '107 postmenopausal women with osteoporosis', 'Postmenopausal Women with Osteoporosis (FRAME']","['placebo', 'romosozumab', 'sclerostin antibody', 'romosozumab or placebo to evaluate histomorphometry and microcomputed tomography-based microarchitectural endpoints', 'Romosozumab']","['bone resorption', 'bone formation', 'bone mass and trabecular thickness with improved trabecular connectivity', 'bone turnover', 'periosteal and endocortical bone', 'cancellous bone formation', 'bone mass and improved microarchitecture']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3661283'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C2350281', 'cui_str': 'Xray Micro-CT'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0442033', 'cui_str': 'Periosteal (qualifier value)'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",,0.273063,"At 12 months, cancellous bone formation was significantly lower (P < 0.05 to P < 0.001) in romosozumab versus placebo and the lower values for resorption endpoints seen at month 2 persisted (P < 0.001), signaling a decrease in bone turnover (P = 0.006).","[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Chavassieux', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Chapurlat', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Portero-Muzy', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Roux', 'Affiliation': 'INSERM UMR 1033, Université de Lyon, Lyon, France.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Garcia', 'Affiliation': 'Endocrinology Service, Osteoporosis Center, University Hospital of Monterrey, Monterrey, Mexico.'}, {'ForeName': 'Jacques P', 'Initials': 'JP', 'LastName': 'Brown', 'Affiliation': 'CHU de Quebec Research Centre and Department of Medicine, Laval University, Quebec, Canada.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Rogely W', 'Initials': 'RW', 'LastName': 'Boyce', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen Inc, Thousand Oaks, CA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3735']
3179,32007978,A double-blind test of blue-blocking filters on symptoms of digital eye strain.,"BACKGROUND


Many ophthalmic lens manufacturers are currently marketing blue-blocking filters, which they claim will reduce symptoms of Digital Eye Strain (DES). However, there is limited evidence to support the proposal that DES results from the blue light emitted by electronic screens.
OBJECTIVE


This investigation compared the effect of blue-blocking filters on DES symptoms with a no-filter lens, using a double-blind methodology.
METHODS


Twenty-four subjects were required to perform a 20-minute reading task from a tablet computer. They wore either lenses containing a blue-blocking filter (TheraBlue 1.67 or TheraBlue polycarbonate) or a CR-39 control lens which did not include a filter. Immediately following each session, subjects completed a questionnaire to quantify symptoms of DES.
RESULTS


While a significant increase in symptoms was observed immediately following the near vision task (p = 0.00001), no significant difference in symptoms was found between the 3 lens conditions (p = 0.74).
CONCLUSIONS


There is little evidence at this time to support the use of blue-blocking filters as a clinical treatment for DES. Management of other ocular factors, as well as the creation of an optimal environment for screen viewing, are more likely to provide greater success in minimizing symptoms.",2020,"While a significant increase in symptoms was observed immediately following the near vision task (p = 0.00001), no significant difference in symptoms was found between the 3 lens conditions (p = 0.74).
",['24 subjects'],"['lenses containing a blue-blocking filter (TheraBlue 1.67 or TheraBlue polycarbonate) or a CR-39 control lens which did not include a filter', 'blue-blocking filters']","['symptoms', 'symptoms of digital eye strain']",[],"[{'cui': 'C0023318', 'cui_str': 'Lenses'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C4517511', 'cui_str': 'One point six seven'}, {'cui': 'C0175905', 'cui_str': 'Polycarbonate (substance)'}, {'cui': 'C0056461', 'cui_str': 'CR39'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0004095', 'cui_str': 'Eyestrain'}]",24.0,0.192081,"While a significant increase in symptoms was observed immediately following the near vision task (p = 0.00001), no significant difference in symptoms was found between the 3 lens conditions (p = 0.74).
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rosenfield', 'Affiliation': 'SUNY College of Optometry, New York, NY, USA.'}, {'ForeName': 'Rui Ting', 'Initials': 'RT', 'LastName': 'Li', 'Affiliation': 'SUNY College of Optometry, New York, NY, USA.'}, {'ForeName': 'Nancy T', 'Initials': 'NT', 'LastName': 'Kirsch', 'Affiliation': 'SUNY College of Optometry, New York, NY, USA.'}]","Work (Reading, Mass.)",['10.3233/WOR-203086']
3180,32061709,Comparison of two different suture knot techniques on postoperative morbidity after impacted mandibular third molar surgery.,"INTRODUCTION


In third molar surgery, one of the most important factors is how the wound was closed. Tight suturing of the wound commonly gives more discomfort to the many patients in terms of postoperative pain, swelling and trismus. The purpose of this study is to investigate the effects of two different knot techniques in suturing after extraction of impacted mandibular third molars (IMTM) on quality of life and postoperative complications such as pain, swelling and trismus.
MATERIAL AND METHODS


This study was conducted with a randomized and split-mouth design and included 50 patients over the age of 18 in the ASA I group who had bilateral horizontal impacted mandibular third molars. In all patients, the wounds were closed by simple sutures by applying two different knot techniques as locked (GroupL, n=50) and unlocked (Group UL, n=50) knots. In the postoperative period, pain, swelling, trismus, chewing activity and quality of life were examined.
RESULTS


In the group where the unlocked knotting technique was used, significantly better results were obtained in comparison to the group where the locked knotting technique was used for all values (P<0.05).
CONCLUSION


In preventing postoperative complications that are observed after impacted mandibular third molar surgery and affect the quality of life of patients negatively, suturing of the wound by the method of unlocked knotting is a useful technique that may be preferred.",2020,"In the group where the unlocked knotting technique was used, significantly better results were obtained in comparison to the group where the locked knotting technique was used for all values (P<0.05).
","['after impacted mandibular third molar surgery', '50 patients over the age of 18 in the ASA I group who had bilateral horizontal impacted mandibular third molars']","['suture knot techniques', 'knot techniques in suturing after extraction of impacted mandibular third molars (IMTM']","['pain, swelling, trismus, chewing activity and quality of life', 'quality of life and postoperative complications such as pain, swelling and trismus', 'postoperative morbidity', 'quality of life', 'postoperative pain, swelling and trismus']","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0699816', 'cui_str': 'Does chew (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",50.0,0.0603259,"In the group where the unlocked knotting technique was used, significantly better results were obtained in comparison to the group where the locked knotting technique was used for all values (P<0.05).
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ege', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Adıyaman University, Adıyaman 02200, Turkey. Electronic address: miregein@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Najafov', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kahramanmaras Sutcu Imam University, Kahramanmaras, Turkey.'}]","Journal of stomatology, oral and maxillofacial surgery",['10.1016/j.jormas.2020.02.002']
3181,31378980,Nutrient supplementation during the first 1000 days and growth of infants born to pregnant adolescents.,"Few studies have evaluated the impact of nutritional supplementation among pregnant adolescents. We examined the effects of the Rang Din Nutrition Study (RDNS) interventions on children born to mothers <20 years of age. The RDNS was a cluster-randomized effectiveness trial with four arms: (1) women and children both received small-quantity lipid-based nutrient supplements (LNS-LNS), (2) women received iron and folic acid (IFA) and children received LNS (IFA-LNS), (3) women received IFA and children received micronutrient powder (MNP) (IFA-MNP), and (4) women received IFA and children received no supplements (IFA-Control). We enrolled 4011 women at <20 weeks gestation; 1552 were adolescents. Among adolescents, prenatal LNS reduced newborn stunting by 25% and small head size by 28% and had a marginally significant effect on newborn wasting, compared with IFA. Low birth weight and preterm birth were reduced only among adolescents with lower food security. Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control). Initiatives targeting pregnant adolescents in similar settings should consider inclusion of small-quantity LNS, particularly for adolescents living in food-insecure households.",2020,Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control).,"['adolescents living in food-insecure households', 'We enrolled 4011 women at <20 weeks gestation; 1552 were adolescents', 'children born to mothers <20 years of age', 'infants born to pregnant adolescents', 'pregnant adolescents']","['Rang Din Nutrition Study (RDNS) interventions', 'Nutrient supplementation', 'small-quantity lipid-based nutrient supplements (LNS-LNS), (2) women received iron and folic acid (IFA) and children received LNS (IFA-LNS), (3) women received IFA and children received micronutrient powder (MNP) (IFA-MNP), and (4) women received IFA and children received no supplements (IFA-Control']","['Low birth weight and preterm birth', 'subsequent growth status', 'newborn wasting', 'newborn stunting']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}]",1552.0,0.0901711,Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control).,"[{'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Susana L', 'Initials': 'SL', 'LastName': 'Matias', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Malay K', 'Initials': 'MK', 'LastName': 'Mridha', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}]",Annals of the New York Academy of Sciences,['10.1111/nyas.14191']
3182,31444189,Effect of 'lifestyle stigma' on public support for NHS-provisioned pre-exposure prophylaxis (PrEP) and preventative interventions for HPV and type 2 diabetes: a nationwide UK survey.,"OBJECTIVES


This study examines how the perceived role of poor lifestyle and irresponsible behaviour in contracting HIV, human papilloma virus (HPV) and diabetes affects public support for government-provisioned prevention efforts in Britain. It assesses whether public attitudes on healthcare spending are broadly sensitive to 'lifestyle stigmas'.
METHODS


We conducted an online survey of 738 respondents in Britain and embedded three separate survey experiments to measure support for government-provisioned interventions for HIV, HPV and type 2 diabetes. In each experiment, we manipulated language used to describe the extent to which the diseases are caused by lifestyle choices. Most respondents participated in all three experiments, but assignment was randomised within each condition. Analysis compared support among respondents exposed to 'lifestyle' treatment (information emphasising the disease's lifestyle causes) versus control treatment. We estimated three separate t-tests in which support for government provision of interventions is the dependent variable.
RESULTS


Support for government-provisioned prevention was high for all three diseases. There was no statistical difference between treatment and control conditions for HIV (treatment mean=3.73, control mean=3.86, p=0.38). But in both HPV (treatment mean=3.96, control mean=4.43, p<0.01) and type 2 diabetes (treatment mean=3.53, control mean=4.03, p<0.01) experiments, support for government-provisioned interventions was significantly lower under lifestyle treatment conditions.
CONCLUSIONS


Public opinion on healthcare expenditures in Britain is unexpected and uneven. Consistent participant support for pre-exposure prophylaxis (PrEP) shows public attitudes are not always sensitive to lifestyle stigmas-but for other diseases, perceived relationships between individual behaviour and poor health can still shape public opinion about health expenditures. Policymakers and practitioners should remain attentive to how health problems are framed and discussed to ensure broad public support, and take advantage of policy windows like with PrEP as they may close.",2019,"But in both HPV (treatment mean=3.96, control mean=4.43, p<0.01) and type 2 diabetes (treatment mean=3.53, control mean=4.03, p<0.01) experiments, support for government-provisioned interventions was significantly lower under lifestyle treatment conditions.
","['738 respondents in Britain and embedded three separate survey experiments to measure support for government-provisioned interventions for HIV, HPV and type 2 diabetes', 'HPV and type 2 diabetes']","['NHS-provisioned pre-exposure prophylaxis (PrEP', 'lifestyle stigma']",[],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",[],738.0,0.0158419,"But in both HPV (treatment mean=3.96, control mean=4.43, p<0.01) and type 2 diabetes (treatment mean=3.53, control mean=4.03, p<0.01) experiments, support for government-provisioned interventions was significantly lower under lifestyle treatment conditions.
","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Social Policy, London School of Economics and Political Science, London, UK T.R.Hildebrandt@lse.ac.uk.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Bode', 'Affiliation': 'Communication, Culture & Technology, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Jessica S C', 'Initials': 'JSC', 'LastName': 'Ng', 'Affiliation': 'Department of Social Policy, London School of Economics and Political Science, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-029747']
3183,30543570,The Effects of Patient Care Results of Applied Nursing Intervention to Individuals With Stoma According to the Health Belief Model.,"BACKGROUND


Individuals who have undergone stoma surgery take time to adjust to the stoma, and their quality of life is decreasing.
OBJECTIVE


The aim of this study was to examine the effects of home-based nursing interventions informed by the Health Belief Model on patient care outcomes for individuals having a stoma.
METHODS


This pretest, posttest, and semiexperimental design with a control group included adults who underwent a stoma operation in the previous 3 months. In total, 30 were assigned to the experimental group and 31 to the control group. Study forms included a sociodemographic questionnaire, the Stoma Quality of Life Scale, the Ostomy Adjustment Inventory, and the Pittman Complication Severity Index.
RESULTS


After home nursing interventions, there was a significant difference between the compliance rates of the individuals in the experimental group and the complication rates and cost averages (P < .05) with individuals in the control group; no significant difference in quality-of-life scores was found between the 2 groups.
CONCLUSION


In order to effectively support postoperative individuals following stoma surgery when they are released from the hospital, postdischarge follow-up care informed by the Health Belief Model components should be offered.
IMPLICATIONS FOR PRACTICE


We recommend creating hospital-based, home care teams that follow individuals with a stoma for at least 6 months after discharge.",2020,"After home nursing interventions, there was a significant difference between the compliance rates of the individuals in the experimental group and the complication rates and cost averages (P < .05) with individuals in the control group; no significant difference in quality-of-life scores was found between the 2 groups.
","['Individuals With Stoma', 'Individuals who have undergone stoma surgery', 'individuals having a stoma']","['home-based nursing interventions', 'Applied Nursing Intervention']","['complication rates and cost averages', 'compliance rates', 'quality-of-life scores', 'sociodemographic questionnaire, the Stoma Quality of Life Scale, the Ostomy Adjustment Inventory, and the Pittman Complication Severity Index']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0029473', 'cui_str': 'Ostomy'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0199895,"After home nursing interventions, there was a significant difference between the compliance rates of the individuals in the experimental group and the complication rates and cost averages (P < .05) with individuals in the control group; no significant difference in quality-of-life scores was found between the 2 groups.
","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Cengiz', 'Affiliation': 'Author Affiliations: Department of Public Health Nursing, Faculty of Nursing, Dokuz Eylül University, Izmir (Dr Cengiz); Department of Public Health Nursing, Faculty of Nursing, Koç University, İstanbul (Prof Bahar); and Department of General Surgery, Faculty of Medicine, Dokuz Eylul University, Izmir (Prof Canda), Turkey.'}, {'ForeName': 'Zuhal', 'Initials': 'Z', 'LastName': 'Bahar', 'Affiliation': ''}, {'ForeName': 'Aras Emre', 'Initials': 'AE', 'LastName': 'Canda', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000678']
3184,32063178,Locomotor training intensity after stroke: Effects of interval type and mode.,"Background and Objectives : High-intensity interval training (HIIT) is a promising strategy for improving gait and fitness after stroke, but optimal parameters remain unknown. We tested the effects of short vs long interval type and over-ground vs treadmill mode on training intensity.  Methods : Using a repeated measures design, 10 participants with chronic hemiparesis performed 12 HIIT sessions over 4 weeks, alternating between short and long-interval HIIT sessions. Both protocols included 10 minutes of over-ground HIIT, 20 minutes of treadmill HIIT and another 10 minutes over-ground. Short-interval HIIT involved 30 second bursts at maximum safe speed and 30-60 second rest periods. Long-interval HIIT involved 4-minute bursts at ~90% of peak heart rate (HR peak ) and 3-minute recovery periods at ~70% HR peak .  Results : Compared with long-interval HIIT, short-interval HIIT had significantly faster mean overground speeds (0.75 vs 0.67 m/s) and treadmill speeds (0.90 vs 0.51 m/s), with similar mean treadmill HR (82.9 vs 81.8%HR peak ) and session perceived exertion (16.3 vs 16.3), but lower overground HR (78.4 vs 81.1%HR peak ) and session step counts (1481 vs 1672). For short-interval HIIT, training speeds and HR were significantly higher on the treadmill vs. overground. For long-interval HIIT, the treadmill elicited HR similar to overground training at significantly slower speeds.  Conclusions : Both short and long-interval HIIT elicit high intensities but emphasize different dosing parameters. From these preliminary findings and previous studies, we hypothesize that overground and treadmill short-interval HIIT could be optimal for improving gait speed and overground long-interval HIIT could be optimal for improving gait endurance.",2020,"Compared with long-interval HIIT, short-interval HIIT had significantly faster mean overground speeds (0.75 vs 0.67 m/s) and treadmill speeds (0.90 vs 0.51 m/s), with similar mean treadmill HR (82.9 vs 81.8%HR peak ) and session perceived exertion (16.3 vs 16.3), but lower overground HR (78.4 vs 81.1%HR peak ) and session step counts (1481 vs 1672).",['10 participants with chronic hemiparesis'],['intensity interval training (HIIT'],"['peak heart rate (HR peak ', 'treadmill speeds']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]",10.0,0.0695711,"Compared with long-interval HIIT, short-interval HIIT had significantly faster mean overground speeds (0.75 vs 0.67 m/s) and treadmill speeds (0.90 vs 0.51 m/s), with similar mean treadmill HR (82.9 vs 81.8%HR peak ) and session perceived exertion (16.3 vs 16.3), but lower overground HR (78.4 vs 81.1%HR peak ) and session step counts (1481 vs 1672).","[{'ForeName': 'Pierce', 'Initials': 'P', 'LastName': 'Boyne', 'Affiliation': 'Department of Rehabilitation, Exercise and Nutrition Sciences, College of Allied Health Sciences, University of Cincinnati , Cincinnati, OH, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Scholl', 'Affiliation': 'Department of Rehabilitation, Exercise and Nutrition Sciences, College of Allied Health Sciences, University of Cincinnati , Cincinnati, OH, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Doren', 'Affiliation': 'Department of Rehabilitation, Exercise and Nutrition Sciences, College of Allied Health Sciences, University of Cincinnati , Cincinnati, OH, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Carl', 'Affiliation': 'Department of Rehabilitation, Exercise and Nutrition Sciences, College of Allied Health Sciences, University of Cincinnati , Cincinnati, OH, USA.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Billinger', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, School of Health Professions, University of Kansas Medical Center , Kansas City, KS, USA.'}, {'ForeName': 'Darcy S', 'Initials': 'DS', 'LastName': 'Reisman', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware , Newark, DE, USA.'}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Gerson', 'Affiliation': 'Departments of Internal Medicine and Cardiology, College of Medicine, University of Cincinnati , Cincinnati, OH, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Kissela', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, College of Medicine, University of Cincinnati , Cincinnati, OH, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Vannest', 'Affiliation': 'Department of Communication Sciences and Disorders, College of Allied Health Sciences, University of Cincinnati , Cincinnati, OH, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Dunning', 'Affiliation': 'Department of Rehabilitation, Exercise and Nutrition Sciences, College of Allied Health Sciences, University of Cincinnati , Cincinnati, OH, USA.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2020.1728953']
3185,32043288,Adding vitamin D3 to the dipeptidyl peptidase-4 inhibitor saxagliptin has the potential to protect β-cell function in LADA patients: A 1-year pilot study.,"AIMS


This trial was conducted to explore the protective effect on β-cell function of adding vitamin D3 to DPP-4 inhibitors to treat patients with latent autoimmune diabetes in adults (LADA).
METHODS


60 LADA patients were randomized to group A (n = 21) - conventional therapy with metformin (1-1.7 g/day) and/or insulin treatment; group B (n = 20) - saxagliptin (5 mg/day) plus conventional therapy; and group C (n = 19) - vitamin D3 (2000 IU/day) plus saxagliptin and conventional therapy for 12 months. Fasting and 2-hour postprandial blood samples were collected to measure blood glucose, glycosylated hemoglobin and C-peptide levels at baseline and after 3, 6 and 12 months of treatment.
RESULTS


During the 12 months of follow-up, the levels of fasting C-peptide (FCP), 2-hour postprandial C-peptide (PCP) and the C-peptide index (CPI, serum C-peptide-to-plasma glucose level ratio) were maintained in group C. In contrast to those in group A and group B, FCP levels decreased significantly in group B, and CPI levels declined significantly in group A during the 1-year treatment (P < .05). Additionally, the levels of GADA titers in group C significantly decreased compared with those at baseline (P < .05), but no significant differences in GADA titers levels were detected in group A and group B. No significant differences were found among the three groups in the levels of FCP, PCP, the CPI or GADA titers.
CONCLUSIONS


The data suggested that adding 2000 IU/day vitamin D3 to saxagliptin might preserve β-cell function in patients with LADA.",2020,"B. No significant differences were found among the three groups in the levels of FCP, PCP, the CPI or GADA titres.
","['patients with LADA', 'Sixty LADA patients', 'LADA Patients']","['saxagliptin and conventional therapy', 'vitamin D3 to saxagliptin', 'conventional therapy with metformin', 'insulin treatment; group B (n\xa0=\xa020) - saxagliptin (5\u2009mg per day) plus conventional therapy', 'Vitamin D3 to the Dipeptidyl Peptidase-4 Inhibitor Saxagliptin', 'vitamin D3 to DPP-4 inhibitors', 'vitamin D3']","['levels of GADA titres', 'levels of FCP, PCP, the CPI or GADA titres', 'CPI levels', 'FCP levels', 'levels of fasting C-peptide (FCP), 2-hour postprandial C-peptide (PCP) and the C-peptide index (CPI, serum C-peptide-to-plasma glucose level ratio', 'GADA titres levels', 'β-cell function', 'blood glucose, glycosylated haemoglobin, and C-peptide levels', 'Fasting and 2-hour postprandial blood samples']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0130753', 'cui_str': 'calpain inhibitor 2'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",60.0,0.021763,"B. No significant differences were found among the three groups in the levels of FCP, PCP, the CPI or GADA titres.
","[{'ForeName': 'Ziwei', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xieyi', 'Initials': 'X', 'LastName': 'Pei', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiangbing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Endocrinology, Metabolism, and Nutrition, Rutgers University-Robert Wood Johnson Medical School, New Brunswick, New Jersey.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Niu', 'Affiliation': 'Department of Endocrinology, Heji Hospital Affiliated to Changzhi Medical College, Changzhi, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': 'Department of Epidemiology and Health Statistics, Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3298']
3186,30121097,"Talking with teens about traffic safety: Initial feasibility, acceptability, and efficacy of a parent-targeted intervention for primary care settings.","INTRODUCTION


The aims of the current pilot study were to evaluate the feasibility, acceptability, and preliminary efficacy of the Talking with Teens about Traffic Safety Program. The program consists of a clinic-based health coaching session with parents of adolescents at their annual well-child visit to promote parent-teen communication about teen driver safety including: a Parent Handbook that is designed to serve as a primer on teen driver safety and facilitate parent-teen communication on a variety of teen driver topics; an interactive practice driving toolset; and an endorsement of the materials by the primary care provider.
METHOD


Fifty-four parent-teen dyads (n = 108 total) were recruited from a primary care practice. Dyads were randomized (1:1) into a treatment group or a usual care group. Implementation fidelity was assessed using checklists completed by health coaches and parent interviews. After 6 months, parents reported how often they talked with their teen about 12 safe driving topics (e.g., state graduated driver licensing laws).
RESULTS


Parents in the treatment group reported more frequent discussions than parents in the control group on 7 out of the 12 topics. Fidelity data indicate that 100% of sessions were implemented as designed and were acceptable to parents.
CONCLUSIONS


The program was feasible to administer and there was evidence for preliminary efficacy. Generally, effects were larger for more infrequently discussed topics, which is to be expected due to the potential for ceiling effects on more commonly discussed topics (e.g., distracted driving). A larger multi-site study is warranted.
PRACTICAL APPLICATIONS


The results from this pilot study provide support for implementation fidelity and establish a proof-of-concept for the Talking with Teens about Traffic Safety Program. The results provide guidance for developing partnerships with pediatricians and parents to develop parent-teen communication interventions on injury prevention topics.",2018,"RESULTS


Parents in the treatment group reported more frequent discussions than parents in the control group on 7 out of the 12 topics.",['Fifty-four parent-teen dyads (n\u202f=\u202f108 total) were recruited from a primary care practice'],"['clinic-based health coaching session with parents of adolescents at their annual well-child visit to promote parent-teen communication about teen driver safety including: a Parent Handbook', 'usual care group']","['Implementation fidelity', 'frequent discussions', 'feasibility, acceptability']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1444717', 'cui_str': 'Well child visit'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0205186,"RESULTS


Parents in the treatment group reported more frequent discussions than parents in the control group on 7 out of the 12 topics.","[{'ForeName': 'Jessica H', 'Initials': 'JH', 'LastName': 'Mirman', 'Affiliation': 'The University of Alabama at Birmingham, Department of Psychology, 1720 2nd Avenue South, Birmingham, AL 35294, USA. Electronic address: jhmirman@uab.edu.'}, {'ForeName': 'Emma S', 'Initials': 'ES', 'LastName': 'Goodman', 'Affiliation': 'The University of Alabama at Birmingham, Department of Psychology, 1720 2nd Avenue South, Birmingham, AL 35294, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Friedrich', 'Affiliation': ""Division of Adolescent Medicine, Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Children's Hospital of Philadelphia, 3401 Civic Center Blvd., 11th floor, Main Building, Suite 11NW10, Philadelphia, PA 19104, USA.""}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Ford', 'Affiliation': ""Division of Adolescent Medicine, Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Children's Hospital of Philadelphia, 3401 Civic Center Blvd., 11th floor, Main Building, Suite 11NW10, Philadelphia, PA 19104, USA.""}]",Journal of safety research,['10.1016/j.jsr.2018.06.008']
3187,32078096,Intracoronary compared with intravenous bolus tirofiban on the microvascular obstruction in patients with STEMI undergoing PCI: a cardiac MR study.,"To investigate the potential effect of intracoronary administration of the glycoprotein IIb/IIIa inhibitor tirofiban on the microvascular obstruction (MVO) assessed by cardiac magnetic resonance (CMR) imaging compared to the intravenous route in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI). Two hundred eight patients were randomized into two groups (tirofiban i.v. and tirofiban i.c.). CMR was completed within 3-7 days after ST-segment-elevation myocardial infarction. One hundred thirty-two patients had a follow-up CMR at 6 months after discharge. The primary end point was the CMR measurements including myocardium strain, myocardial perfusion index, final infarct size, prevalence and extent of MVO, and the change of left ventricular end-diastolic volume (LVEDV) at six months follow-up. The second endpoint was major adverse cardiovascular events (composite of all-cause death, nonfatal reinfarction and congestive heart failure) in one year. The MVO prevalence and extent [56% versus 36%, p = 0.004; 2.08 (IQR: 1.18-5.07) g versus 1.68 (IQR: 0.30-3.28) g, p = 0.041] showed a significant difference between the intravenous and intracoronary groups. Global left ventricular peak longitudinal strain was significantly different in intracoronary groups compared to intravenous groups, - 12.5 [IQR: - 13.4 to - 10.9] versus - 12.3 [IQR: - 13.4 to - 10.4], respectively (P = 0.042). Infarcted myocardial perfusion index was significantly different in intracoronary groups compared to intravenous groups, 0.11 [IQR: 0.08 to 0.15] versus 0.09 [IQR: 0.07 to 0.14], respectively (P = 0.026). Intracoronary tirofiban was associated with a higher change in LVEDV compared with intravenous group (- 10.2% [IQR: - 13.7% to - 2.6%] versus 1.3% [IQR: - 5.6% to 6.1%], p < 0.001). Intracoronary tirofiban application showed no benefit on the occurrence of major adverse cardiovascular events during follow-up compared to intravenous administration. This CMR study in ST-segment-elevation myocardial infarction patients showed a benefit in MVO and left ventricular remodeling for intracoronary tirofiban administration compared to intravenous administration in patients undergoing PCI.",2020,"The MVO prevalence and extent [56% versus 36%, p = 0.004; 2.08 (IQR: 1.18-5.07)","['patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI', 'patients with STEMI undergoing PCI', 'Two hundred eight patients', 'patients undergoing PCI']","['Intracoronary tirofiban', 'glycoprotein IIb/IIIa inhibitor tirofiban', 'intracoronary tirofiban', 'intravenous bolus tirofiban', 'Intracoronary', 'tirofiban i.v. and tirofiban', 'cardiac magnetic resonance (CMR) imaging']","['microvascular obstruction', 'CMR', 'microvascular obstruction (MVO', 'major adverse cardiovascular events (composite of all-cause death, nonfatal reinfarction and congestive heart failure', 'Global left ventricular peak longitudinal strain', 'CMR measurements including myocardium strain, myocardial perfusion index, final infarct size, prevalence and extent of MVO, and the change of left ventricular end-diastolic volume (LVEDV', 'occurrence of major adverse cardiovascular events', 'LVEDV', 'Infarcted myocardial perfusion index', 'MVO prevalence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027061', 'cui_str': 'Muscle, Cardiac'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",208.0,0.0251666,"The MVO prevalence and extent [56% versus 36%, p = 0.004; 2.08 (IQR: 1.18-5.07)","[{'ForeName': 'Quanmei', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Xiaonan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China.""}, {'ForeName': 'Tongtong', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Duan', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Jiake', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Zongyu', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Yundi', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': ""Department of Radiology, Shengjing Hospital of China Medical University, No. 36 Sanhao Street, Heping District, Shenyang, 110004, Liaoning, People's Republic of China. houyang_1973@sina.com.""}]",The international journal of cardiovascular imaging,['10.1007/s10554-020-01800-0']
3188,32076866,Effect of different concentrations of commercially available mouthwashes on wound healing following periodontal surgery: a randomized controlled clinical trial.,"OBJECTIVES


The purpose of this study was to evaluate the effect of chlorhexidine and essential oils containing mouth rinses on oral wound healing after periodontal flap surgery.
MATERIALS AND METHODS


Eighty subjects participated in the study and were randomly assigned to use water, 0.12% chlorhexidine (CHX), essential oils (EO), 5% CHX, and 10% EO. Subjects were examined at 1, 2, and 3 weeks postoperatively. Plaque index (PI) and the modified gingival index (GI) were recorded, while wound epithelialization was measured to evaluate the healing process. Numerical data were analyzed with parametric test for multiple comparisons (ANOVA) with Bonferroni correction. Categorical data were analyzed using Chi-square test/fisher exact test.
RESULTS


All groups demonstrated a gradual GI reduction from first to third visit. Patients in the CHX group presented statistically significant lower PI scores than patients in the water group at the all-time points of the study. Wound epithelialization analysis demonstrated that 100% of the sites in the CHX group were healing by secondary intention at visit 1. This finding was statistically significant.
CONCLUSION


Full strength concentrations of CHX and EO did not show any detrimental effects on healing after traditional periodontal surgery at the end of the observation period.
CLINICAL RELEVANCE


The use of chlorhexidine and EO containing mouthwashes does not appear to delay wound healing. Diluting these commercial mouthwashes may present an approach that could possibly reduce the adverse effects (such as tooth staining) associated with their use, while maintaining their antibacterial properties.",2020,"Full strength concentrations of CHX and EO did not show any detrimental effects on healing after traditional periodontal surgery at the end of the observation period.
","['periodontal surgery', 'Eighty subjects participated in the study and were randomly assigned to use water, 0.12']","['chlorhexidine and essential oils containing mouth rinses', 'CHX', 'chlorhexidine (CHX), essential oils (EO), 5% CHX, and 10% EO', 'chlorhexidine and EO containing mouthwashes']","['PI scores', 'adverse effects', 'Wound epithelialization analysis', 'wound epithelialization', 'delay wound healing', 'Plaque index (PI) and the modified gingival index (GI', 'gradual GI reduction', 'oral wound healing', 'wound healing']","[{'cui': 'C0398950', 'cui_str': 'Periodontal operation (procedure)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C4517426', 'cui_str': '0.12 (qualifier value)'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3266038', 'cui_str': 'Wound Epithelialization'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",80.0,0.0616574,"Full strength concentrations of CHX and EO did not show any detrimental effects on healing after traditional periodontal surgery at the end of the observation period.
","[{'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Katsaros', 'Affiliation': 'Department of Periodontics, University of Iowa College of Dentistry and Dental Clinics, 801 Newton Rd., S447, Iowa City, IA, 52241, USA. theodoros-katsaros@uiowa.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mayer', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, New Orleans, LA, USA.'}, {'ForeName': 'Archontia', 'Initials': 'A', 'LastName': 'Palaiologou', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Romero-Bustillos', 'Affiliation': 'Department of Periodontics, University of Iowa College of Dentistry and Dental Clinics, 801 Newton Rd., S447, Iowa City, IA, 52241, USA.'}, {'ForeName': 'Gerald H', 'Initials': 'GH', 'LastName': 'Evans', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, New Orleans, LA, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Lallier', 'Affiliation': 'Department of Cell Biology and Anatomy, Louisiana State University Health Sciences Center, New Orleans, LA, 70119, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Maney', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, New Orleans, LA, USA.'}]",Clinical oral investigations,['10.1007/s00784-020-03232-5']
3189,31375458,Prediction of maximum oxygen uptake through incremental exercise testing using ventilometry: a cross-sectional study.,"BACKGROUND


Cardiopulmonary exercise testing is the main tool assessing cardiorespiratory fitness. However, cardiopulmonary exercise testing devices are expensive and often cannot be used.
OBJECTIVE


The present study sought to develop cardiopulmonary exercise testing equations for estimating maximum oxygen uptake from ergometric testing combined with ventilometry.
METHODS


181 volunteers of both sexes were submitted to cardiopulmonary exercise testing on treadmill using an incremental protocol. Volunteers were randomized into two groups: regression group: composed of 68 women with age 24.7±6.0 years and 54 men aged 21.5±3.9 years; and a cross-validation group composed of 29 women with mean age of 23.8±4.7 years and 30 men with a mean age of 23.1±4.4 years. The estimating equations were developed using multiple stepwise linear regressions; comparison of means was done using a t test and reliability assessed by Cronbach's alpha.
RESULTS


8 independent variables exhibited a significant result for estimating VO 2max : minute ventilation (E) at second ventilatory threshold (VT-II): (E _VT-II); heart rate at VT-II (HR_VT-II); body mass (BM); body mass index (BMI); fat percentage (F%); age; sex; velocity at VT-II (Vel_VT-II); test time of VT-II (T_VT-II) and final test velocity (Vel final ). Two equations presented more accurate results; for active subjects: Equation 2  = 33.08 + 2.41*(Vel final ) - 0.32*(F%) + 0.40*(VE_VT-II) - 0.26*(BM) - 0.09*(HR_VT-II); for sedentary subjects: Equation 3  for = 54.65 + 1.37*(T_VT-II) + 8.24*(sex) - 1.26*(BMI) + 0.37*(VE_VT-II) - 0.12*(HR_VT-II).
CONCLUSION


The present study demonstrated that the use of parameters collected during maximal ergometric test combined with ventilometry, improved the accuracy of equations for estimating maximum oxygen uptake.",2020,"Two equations presented more accurate results; for active subjects: Equation 2  = 33.08 + 2.41*(Vel final ) - 0.32*(F%) + 0.40*(VE_VT-II) - 0.26*(BM) - 0.09*(HR_VT-II); for sedentary subjects: Equation 3  for = 54.65 + 1.37*(T_VT-II) + 8.24*(sex) - 1.26*(BMI) + 0.37*(VE_VT-II) - 0.12*(HR_VT-II).
","['181 volunteers of both sexes', '68 women with age 24.7±6.0 years end 54 men aged 21.5±3.9 years; and cross-validation group: was composed 29 women with mean age 23.8±4.7 years and 30 men with mean 23.1±4.4 years']","['incremental exercise testing using ventilometry', 'Cardiopulmonary exercise testing on treadmill using an incremental protocol', 'Cardiopulmonary exercise testing equations']",['estimating VO 2max : minute ventilation (E) at second ventilatory threshold (VT-II): (E _VT-II); heart rate at VT-II (HR_VT-II); body mass (BM); body mass index (BMI); fat percentage (F%); age; sex; velocity at VT-II (Vel_VT-II); test time of VT-II (T_VT-II) and final test velocity (Vel final '],"[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0429928', 'cui_str': 'Test time (observable entity)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",181.0,0.0202251,"Two equations presented more accurate results; for active subjects: Equation 2  = 33.08 + 2.41*(Vel final ) - 0.32*(F%) + 0.40*(VE_VT-II) - 0.26*(BM) - 0.09*(HR_VT-II); for sedentary subjects: Equation 3  for = 54.65 + 1.37*(T_VT-II) + 8.24*(sex) - 1.26*(BMI) + 0.37*(VE_VT-II) - 0.12*(HR_VT-II).
","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Policarpo Barbosa', 'Affiliation': 'Laboratory of Human Movement Biosciences, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil. Electronic address: fernandopolicarpo65@gmail.com.'}, {'ForeName': 'Paulo Eugênio', 'Initials': 'PE', 'LastName': 'Silva', 'Affiliation': 'Post-Graduate Program in Science and Technology in Health, Universidade de Brasília (UnB), Brasília, DF, Brazil.'}, {'ForeName': 'Andréa Carmen', 'Initials': 'AC', 'LastName': 'Guimarães', 'Affiliation': 'Laboratory of Human Movement Biosciences, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil; Department of Physical Education and Health Sciences, Universidade Federal de São João Del-Rei (UFSJ), São João del Rei, MG, Brazil.'}, {'ForeName': 'Carlos Soares', 'Initials': 'CS', 'LastName': 'Pernambuco', 'Affiliation': ""Doctor's Degree Program in Nursing and Biosciences - PPgEnfBio, Federal University of the State of Rio de Janeiro - UNIRIO, Rio de Janeiro, Brazil; Master and Doctor's Degree Program in Health and Environment - PSA, Tiradentes University - UNIT, Aracaju, Brazil.""}, {'ForeName': 'Estélio Henrique', 'Initials': 'EH', 'LastName': 'Dantas', 'Affiliation': ""Doctor's Degree Program in Nursing and Biosciences - PPgEnfBio, Federal University of the State of Rio de Janeiro - UNIRIO, Rio de Janeiro, Brazil; College of Physical Education, Universidade Tiradentes, Aracajú, SE, Brazil.""}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.07.002']
3190,31776849,"Outcomes of a text message, Fitbit, and coaching intervention on physical activity maintenance among cancer survivors: a randomized control pilot trial.","PURPOSE


We aimed to determine the effect of a health coach, text message, and Fitbit intervention on moderate-to-vigorous physical activity (MVPA) maintenance in cancer survivors following a supervised exercise program compared to provision of a Fitbit alone.
METHODS


Participants were recruited during the last month of an exercise-based oncology rehabilitation program and randomly assigned to the full intervention (n = 34) or Fitbit-only control groups (n = 32). In total, 59 cancer survivors completed the program (81% female; mean age 61.4 ± 9.0). Group by time differences in accelerometer-measured MVPA was assessed using linear mixed models. Additionally, we examined mean weekly Fitbit-derived MVPA levels.
RESULTS


Intervention participants maintained weekly MVPA from pre- (295.7 ± 139.6) to post-intervention (322.0 ± 199.4; p = 0.37), whereas those in the Fitbit-only group had a significant decrease in MVPA (305.5 ± 181.1 pre vs 250.7 ± 166.5 post; p = 0.03, effect size 0.57). The intervention participants maintained recommended levels of MPVA for health benefits during the 8-week intervention, whereas the Fitbit-only control group did not.
CONCLUSIONS


The findings demonstrate that a remote intervention delivered through health coaching, text messages, and Fitbit can promote maintenance of MVPA after a structured program for cancer survivors. However, use of a Fitbit alone was not sufficient to prevent expected decline in MVPA. Additional research is warranted to examine long-term impacts and efficacy in a more diverse population of cancer survivors.
IMPLICATIONS FOR CANCER SURVIVORS


Use of a wearable tracker alone may not be sufficient for exercise maintenance among cancer survivors after transition to an independent program. Additional planning for relapse prevention is recommended.",2020,"RESULTS


Intervention participants maintained weekly MVPA from pre- (295.7 ± 139.6) to post-intervention (322.0 ± 199.4; p = 0.37), whereas those in the Fitbit-only group had a significant decrease in MVPA (305.5 ± 181.1 pre vs 250.7 ± 166.5 post; p = 0.03, effect size 0.57).","['59 cancer survivors completed the program (81% female; mean age 61.4 ± 9.0', 'Participants were recruited during the last month of an', 'cancer survivors']","['exercise-based oncology rehabilitation program and randomly assigned to the full intervention (n = 34) or Fitbit-only control groups', 'health coach, text message, and Fitbit intervention', 'text message, Fitbit, and coaching intervention', 'supervised exercise program']","['levels of MPVA for health benefits', 'MVPA', 'physical activity maintenance']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",,0.0422907,"RESULTS


Intervention participants maintained weekly MVPA from pre- (295.7 ± 139.6) to post-intervention (322.0 ± 199.4; p = 0.37), whereas those in the Fitbit-only group had a significant decrease in MVPA (305.5 ± 181.1 pre vs 250.7 ± 166.5 post; p = 0.03, effect size 0.57).","[{'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Gell', 'Affiliation': 'Department of Rehabilitation and Movement Science, University of Vermont, 306B Rowell 106 Carrigan Drive, Burlington, VT, 05405, USA. nancy.gell@med.uvm.edu.'}, {'ForeName': 'Kristin W', 'Initials': 'KW', 'LastName': 'Grover', 'Affiliation': 'University of Vermont Cancer Center, Burlington, VT, USA.'}, {'ForeName': 'Liliane', 'Initials': 'L', 'LastName': 'Savard', 'Affiliation': 'Department of Rehabilitation and Movement Science, University of Vermont, 306B Rowell 106 Carrigan Drive, Burlington, VT, 05405, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dittus', 'Affiliation': 'University of Vermont Cancer Center, Burlington, VT, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00831-4']
3191,31360754,Successful management of bullous pemphigoid with dimethyl fumarate therapy: A case report.,"A 69-year-old woman affected by multiple sclerosis for 35 years was diagnosed with bullous pemphigoid (BP) and treated successfully with dimethyl fumarate (DMF) at a dose of 120 mg twice per day for 7 days and then increased to 240 mg twice per day after first-line therapies of BP. DMF is now under evaluation with an investigator-initiated prospective controlled trial in patients with BP to determine the efficacy and safety of adjuvant DMF. To our knowledge, this is the first case of BP successfully treated with DMF in the literature.",2019,A 69-year-old woman affected by multiple sclerosis for 35 years was diagnosed with bullous pemphigoid (BP) and treated successfully with dimethyl fumarate (DMF) at a dose of 120 mg twice per day for 7 days and then increased to 240 mg twice per day after first-line therapies of BP.,"['A 69-year-old woman affected by multiple sclerosis for 35 years was diagnosed with bullous pemphigoid (BP) and treated successfully with', 'patients with BP']","['dimethyl fumarate therapy', 'dimethyl fumarate (DMF', 'DMF']",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030805', 'cui_str': 'Pemphigoid'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0270295,A 69-year-old woman affected by multiple sclerosis for 35 years was diagnosed with bullous pemphigoid (BP) and treated successfully with dimethyl fumarate (DMF) at a dose of 120 mg twice per day for 7 days and then increased to 240 mg twice per day after first-line therapies of BP.,"[{'ForeName': 'Aslı', 'Initials': 'A', 'LastName': 'Bilgic-Temel', 'Affiliation': 'St George Hospital, Department of Dermatology, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'St George Hospital, Department of Dermatology, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Dedee F', 'Initials': 'DF', 'LastName': 'Murrell', 'Affiliation': 'St George Hospital, Department of Dermatology, University of New South Wales, Sydney, Australia.'}]",International journal of women's dermatology,['10.1016/j.ijwd.2019.02.001']
3192,3102127,Action of a prostaglandin synthetase inhibitor on IUD associated uterine bleeding.,"The Authors treated twenty-eight women using IUD, who suffered from increased menstrual blood loss and pelvic pain, with a prostaglandin synthetase inhibitor, Suprofen, in an attempt to reduce their symptomatology, in a double blind crossover study. The drug produced an important reduction of the menstrual blood loss and pains. These observations suggest that prostaglandins are involved in the etiology of excessive menstrual blood loss and pains, and that prostaglandin inhibitors may be useful for reducing these symptoms.",1987,The drug produced an important reduction of the menstrual blood loss and pains.,[],['prostaglandin synthetase inhibitor'],"['IUD associated uterine bleeding', 'menstrual blood loss and pelvic pain', 'menstrual blood loss and pains']",[],"[{'cui': 'C0033551', 'cui_str': 'Prostaglandin H2 Synthetase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0042134', 'cui_str': 'Uterine Bleeding'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood (substance)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",28.0,0.0962675,The drug produced an important reduction of the menstrual blood loss and pains.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Lieto', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Catalano', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Miranda', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Paladini', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
3193,31358145,Learning curve of two common Descemet membrane endothelial keratoplasty graft preparation techniques.,"OBJECTIVE


To compare the learning curve of two Descemet membrane endothelial keratoplast (DMEK) graft preparation techniques.
DESIGN


Experimental study.
PARTICIPANTS


Twenty paired donor corneoscleral rims.
METHODS


The corneas were randomized to DMEK peeling using the peripheral blunt dissection technique (n = 10) or the modified submerged cornea using backgrounds away (mSCUBA) technique (n = 10). Outcome measures included graft peeling time, surgeon's peeling difficulty grading (on a scale of 1 to 10, 1 being the easiest and 10 the hardest), number of tears, and percentage tissue loss.
RESULTS


Average graft peeling time using the peripheral blunt dissection technique and the mSCUBA technique was 15.75 ± 4.01 minutes and 8.43 ± 3.26 minutes, respectively (p < 0.0005). The first 3 grafts' average peeling time was longer than the last 7 grafts: 19.14 ± 2.40 versus 14.21 ± 3.50 minutes in the peripheral blunt dissection technique (p = 0.06) and 12.36 ± 3.76 versus 6.67 ± 0.49 minutes in the mSCUBA technique (p = 0.016). In the latter, there were significantly fewer radial tears compared to the former: 1.5 ± 1.0 and 3.1 ± 1.9, respectively (p = 0.049). No tissue loss was noted in the mSCUBA group compared to one (10%) in the peripheral blunt dissection group. The average difficulty grading for the mSCUBA was significantly lower than the peripheral blunt dissection technique: 3.3 ± 1.9 and 5.8 ± 1.6, respectively (p = 0.024).
CONCLUSIONS


Our study suggests a shorter learning curve with the mSCUBA technique for DMEK graft preparation, with shorter peeling time and fewer complications in comparison to the peripheral blunt dissection technique.",2019,No tissue loss was noted in the mSCUBA group compared to one (10%) in the peripheral blunt dissection group.,['Twenty paired donor corneoscleral rims'],"['Descemet membrane endothelial keratoplast (DMEK) graft preparation techniques', 'peripheral blunt dissection technique (n\u202f=\u202f10) or the modified submerged cornea using backgrounds away (mSCUBA) technique']","['radial tears', 'Average graft peeling time', ""graft peeling time, surgeon's peeling difficulty grading (on a scale of 1 to 10, 1 being the easiest and 10 the hardest), number of tears, and percentage tissue loss"", 'tissue loss', 'average peeling time']","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0556630', 'cui_str': 'Anal penetration using tongue (finding)'}]","[{'cui': 'C0011665', 'cui_str': 'Descemet Membrane'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0010031', 'cui_str': 'Cornea'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0441602', 'cui_str': 'Peeling - action (qualifier value)'}]",20.0,0.0343654,No tissue loss was noted in the mSCUBA group compared to one (10%) in the peripheral blunt dissection group.,"[{'ForeName': 'Ruti', 'Initials': 'R', 'LastName': 'Sella', 'Affiliation': 'Department of Ophthalmology, Shiley Eye Institute, University of California San Diego, La Jolla, Calif.. Electronic address: rsella@ucsd.edu.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Einan-Lifshitz', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ont.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Sorkin', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ont.'}, {'ForeName': 'Clara C', 'Initials': 'CC', 'LastName': 'Chan', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ont.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Afshari', 'Affiliation': 'Department of Ophthalmology, Shiley Eye Institute, University of California San Diego, La Jolla, Calif.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rootman', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ont.'}]",Canadian journal of ophthalmology. Journal canadien d'ophtalmologie,['10.1016/j.jcjo.2018.09.008']
3194,32024950,"Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).","Current guidelines for smoldering multiple myeloma (SMM) recommend active monitoring until the onset of multiple myeloma (MM) before initiating treatment or enrollment in a clinical trial. Earlier intervention may delay progression to MM. In CENTAURUS, 123 patients with intermediate-risk or high-risk SMM were randomly assigned to daratumumab 16 mg/kg intravenously on extended intense (intense), extended intermediate (intermediate), or short dosing schedules. At the prespecified primary analysis (15.8-month median follow-up), the complete response (CR) rates (co-primary endpoint) were 2.4%, 4.9%, and 0% for intense, intermediate, and short dosing, respectively; the co-primary endpoint of CR rate >15% was not met. Progressive disease (PD)/death rates (number of patients who progressed or died divided by total duration of progression-free survival [PFS] in patient-years; co-primary endpoint) for intense, intermediate, and short dosing were 0.055 (80% confidence interval [CI], 0.014-0.096), 0.102 (80% CI, 0.044-0.160), and 0.206 (80% CI, 0.118-0.295), respectively, translating to a median PFS ≥24 months in all arms (P < 0.0001, <0.0001, and =0.0213, respectively). With longer follow-up (median follow-up, 25.9 months), CR rates were 4.9%, 9.8%, and 0% for intense, intermediate, and short dosing, respectively. PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms). Twenty-four-month PFS rates were 89.9% (90% CI, 78.5-95.4%), 82.0% (90% CI, 69.0-89.9%), and 75.3% (90% CI, 61.1-85.0%) for intense, intermediate, and short dosing, respectively. Pharmacokinetic analyses indicated that intense dosing maintained target-saturating trough concentrations in most patients throughout weekly, every-2-week, and every-4-week dosing periods. No new safety signals were observed. These data provide the basis for an ongoing phase 3 study of daratumumab in SMM.",2020,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","['patients with intermediate-risk or high-risk smoldering multiple myeloma', '123 patients with intermediate-risk or high-risk SMM']","['Daratumumab monotherapy', 'daratumumab 16\u2009mg/kg intravenously on extended intense (intense), extended intermediate (intermediate']","['Progressive disease (PD)/death rates', 'CR rates', 'CR rate', 'PD/death rates', 'PFS rates', 'complete response (CR) rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1531608', 'cui_str': 'Asymptomatic Multiple Myeloma'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",123.0,0.0578349,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","[{'ForeName': 'C Ola', 'Initials': 'CO', 'LastName': 'Landgren', 'Affiliation': 'Department of Medicine, Myeloma Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA. landgrec@mskcc.org.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': 'Department of Hematology, Tel-Aviv Sourasky (Ichilov) Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Haematology Department, Concord Cancer Centre, Concord Hospital, University of Sydney, Concord, NSW, Australia.'}, {'ForeName': 'Irwindeep', 'Initials': 'I', 'LastName': 'Sandhu', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Clinical Haematology, Nottingham University Hospitals, Nottinghamshire, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, ""Seràgnoli"" Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Hospital Heidelberg and National Center of Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kuppens', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Bandekar', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Clemens', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Hematology & Oncology, Winship Cancer Institute of Emory University, Atlanta, GA, USA. Craig.Hofmeister@emory.edu.'}]",Leukemia,['10.1038/s41375-020-0718-z']
3195,32071431,Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial.,"We report a randomized prospective phase 3 study (CLL7), designed to evaluate the efficacy of fludarabine, cyclophosphamide, and rituximab (FCR) in patients with an early-stage high-risk chronic lymphocytic leukemia (CLL). Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10 U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12). Two hundred and one patients with ≥2 risk features were classified as high-risk CLL and 1:1 randomized to receive either immediate therapy with 6xFCR (Hi-FCR, 100 patients), or to be observed according to standard of care (Hi-W&W, 101 patients). The overall response rate after early FCR was 92.7%. Common adverse events were hematological toxicities and infections (61.0%/41.5% of patients, respectively). After median observation time of 55.6 (0-99.2) months, event-free survival was significantly prolonged in Hi-FCR compared with Hi-W&W patients (median not reached vs. 18.5 months, p < 0.001). There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864). In conclusion, although FCR is efficient to induce remissions in the Binet A high-risk CLL, our data do not provide evidence that alters the current standard of care ""watch and wait"" for these patients.",2020,"There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864).","['Two hundred and one patients with ≥2 risk features were classified as high-risk CLL', 'patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL', 'Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10\u2009U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12', 'patients with an early-stage high-risk chronic lymphocytic leukemia (CLL']","['immediate therapy with 6xFCR', 'fludarabine, cyclophosphamide, and rituximab (FCR', 'FCR']","['hematological toxicities and infections', 'overall survival benefit', 'overall response rate', 'event-free survival']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040078', 'cui_str': 'Deoxythymidine Kinase'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0432408', 'cui_str': 'Trisomy 12 (disorder)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",800.0,0.142644,"There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864).","[{'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Herling', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany. carmen.herling@uk-koeln.de.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Cymbalista', 'Affiliation': ""Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.""}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Groß-Ophoff-Müller', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Langerbeins', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Othman', 'Initials': 'O', 'LastName': 'Al-Sawaf', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Raymonde', 'Initials': 'R', 'LastName': 'Busch', 'Affiliation': 'Institute for Medical Statistics and Epidemiology, Technical University, Munich, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': 'Center of Clinical Epidemiology, Hopital Hotel-Dieu, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cazin', 'Affiliation': 'Service de Maladies du Sang, CHU Claude Huriez, Lille Cedex, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreyfus', 'Affiliation': ""Service d'Hematologie, CHU Poitiers, Poitiers, France.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ibach', 'Affiliation': 'WiSP Wissenschaftlicher Service Pharma GmbH, Langenfeld, Germany.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leprêtre', 'Affiliation': 'Inserm Unit U1245 and Department of Hematology, Cancer Centre Henri Becquerel and Normandie University Rouen, Rouen, France.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Day Clinic Hematology Oncology Palliative Care, Landshut, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Clemens-Martin', 'Initials': 'CM', 'LastName': 'Wentner', 'Affiliation': 'Department of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Manuela A', 'Initials': 'MA', 'LastName': 'Hoechstetter', 'Affiliation': 'Department of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Leblond', 'Affiliation': 'Department of Haematology, Hopital de la Pitie-Salpetriere, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Letestu', 'Affiliation': ""Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.""}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Levy', 'Affiliation': 'Unite de Recherche Clinique, Hopital Avicenne, Bobigny, France.'}]",Leukemia,['10.1038/s41375-020-0747-7']
3196,31548616,Effect of self-initiated and fully-automated self-measurement on blood pressure.,"Self-measurement of blood pressure (BP) is regularly used to diagnose hypertension and to monitor BP at home. We recently showed that self-measurement of BP may elicit a pressor or 'auto-cuff' response. In this study we examined whether the pressor response is different between self-initiated and fully-automated BP measurement. We performed two randomized crossover studies in outpatients visiting a hypertension clinic. The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography. The second cohort consisted of 120 patients who performed three self-initiated and three fully-automated BP measurements. In the first cohort (mean age 61.2 ± 10.4 years, mean office BP 142.0 ± 19.9/82.5 ± 12.2 mmHg, 36.7% female) average systolic and diastolic BP increased by 7.3 ± 8.5/3.3 ± 4.0 mmHg in the group with self-initiated BP measurements, while BP increased by 3.3 ± 6.3/1.4 ± 3.0 mmHg during fully-automated measurements (p = 0.002/p = 0.002 for difference between groups). The higher BP increase during self-initiated BP measurements resulted from an increase in heart rate and cardiac output. In the second cohort (mean age 58.0 ± 14.1 years, mean office BP 153.6 ± 23.8/86.3 ± 14.0 mmHg, 44.1% female) self-initiated BP measurement resulted in a 2.1 ± 6.8/0.9 ± 4.0 mmHg higher systolic and diastolic BP compared with fully-automated self-measurement (p = 0.001/0.018). In conclusion, our findings suggest that self-initiated BP measurement using a fully-automated method results in a more reliable BP compared with a self-initiated semi-automated method by attenuating the auto-cuff response. These findings may have implications for the self-measurement of BP.",2020,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","['outpatients visiting a hypertension clinic', '120 patients who performed three self-initiated and three fully-automated BP measurements', 'In the second cohort (mean age 58.0\u2009±\u200914.1 years, mean office BP 153.6\u2009±\u200923.8/86.3\u2009±\u200914.0\u2009mmHg, 44.1% female']",['self-initiated and fully-automated self-measurement'],"['blood pressure', 'systolic and diastolic BP', 'heart rate and cardiac output', 'pressor response', 'self-initiated BP measurement', 'Self-measurement of blood pressure (BP']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3715181', 'cui_str': 'Hypertension clinic (environment)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",52.0,0.024403,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","[{'ForeName': 'Rosanne T', 'Initials': 'RT', 'LastName': 'Berkhof', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Gazzola', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands. b.j.vandenborn@amsterdamumc.nl.'}]",Journal of human hypertension,['10.1038/s41371-019-0256-1']
3197,32047578,Remote Ischaemic Preconditioning Reduces Kidney Injury Biomarkers in Patients Undergoing Open Surgical Lower Limb Revascularisation: A Randomised Trial.,"Background and Aims


Perioperative kidney injury affects 12.7% of patients undergoing lower limb revascularisation surgery. Remote ischaemic preconditioning (RIPC) is a potentially protective procedure against organ damage and consists of short nonlethal episodes of ischaemia. The main objective of this substudy was to evaluate the effect of RIPC on kidney function, inflammation, and oxidative stress in patients undergoing open surgical lower limb revascularisation.  Materials and Methods . This is a subgroup analysis of a randomised, sham-controlled, double-blinded, single-centre study. A RIPC or a sham procedure was performed noninvasively along with preparation for anaesthesia in patients undergoing open surgical lower limb revascularisation. The RIPC protocol consisted of 4 cycles of 5 minutes of ischaemia, with 5 minutes of reperfusion between every episode. Blood was collected for analysis preoperatively, 2, 8, and 24 hours after surgery, and urine was collected preoperatively and 24 hours after surgery.
Results


Data of 56 patients were included in the analysis. Serum creatinine, cystatin C, and beta-2 microglobulin increased, and eGFR decreased across all time points significantly more in the sham group than in the RIPC group ( p  = 0.021,  p  = 0.021,  p  = 0.021,  p  = 0.021,  p  = 0.021.
Conclusions


Our finding of reduced release of kidney injury biomarkers may indicate the renoprotective effect of RIPC in patients undergoing open surgical lower limb revascularisation. The trial is registered with ClinicalTrials.gov NCT02689414.",2020,"Serum creatinine, cystatin C, and beta-2 microglobulin increased, and eGFR decreased across all time points significantly more in the sham group than in the RIPC group ( p  = 0.021,  p  = 0.021,  p  = 0.021,  p  = 0.021,  p  = 0.021.
","['patients undergoing open surgical lower limb revascularisation', '56 patients were included in the analysis', 'patients undergoing lower limb revascularisation surgery', 'Patients Undergoing Open Surgical Lower Limb Revascularisation']","['Remote ischaemic preconditioning (RIPC', 'Remote Ischaemic Preconditioning', 'RIPC']","['Kidney Injury Biomarkers', 'Serum creatinine, cystatin C, and beta-2 microglobulin increased, and eGFR', 'kidney function, inflammation, and oxidative stress']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0855565', 'cui_str': 'Beta 2 microglobulin high'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}]",56.0,0.464107,"Serum creatinine, cystatin C, and beta-2 microglobulin increased, and eGFR decreased across all time points significantly more in the sham group than in the RIPC group ( p  = 0.021,  p  = 0.021,  p  = 0.021,  p  = 0.021,  p  = 0.021.
","[{'ForeName': 'Teele', 'Initials': 'T', 'LastName': 'Kasepalu', 'Affiliation': 'Department of Surgery, Institute of Clinical Medicine, University of Tartu, Estonia.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kuusik', 'Affiliation': 'Department of Biochemistry, Institute of Biomedicine and Translational Medicine, Centre of Excellence for Genomics and Translational Medicine, University of Tartu, Estonia.'}, {'ForeName': 'Urmas', 'Initials': 'U', 'LastName': 'Lepner', 'Affiliation': 'Department of Surgery, Institute of Clinical Medicine, University of Tartu, Estonia.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Starkopf', 'Affiliation': 'Tartu University Hospital, Estonia.'}, {'ForeName': 'Mihkel', 'Initials': 'M', 'LastName': 'Zilmer', 'Affiliation': 'Department of Biochemistry, Institute of Biomedicine and Translational Medicine, Centre of Excellence for Genomics and Translational Medicine, University of Tartu, Estonia.'}, {'ForeName': 'Jaan', 'Initials': 'J', 'LastName': 'Eha', 'Affiliation': 'Department of Cardiology, Institute of Clinical Medicine, University of Tartu, Estonia.'}, {'ForeName': 'Mare', 'Initials': 'M', 'LastName': 'Vähi', 'Affiliation': 'Department of Mathematics and Statistics, Faculty of Science and Technology, University of Tartu, Estonia.'}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Kals', 'Affiliation': 'Department of Surgery, Institute of Clinical Medicine, University of Tartu, Estonia.'}]",Oxidative medicine and cellular longevity,['10.1155/2020/7098505']
3198,32050899,Implementation of the Goal-directed Medication review Electronic Decision Support System (G-MEDSS)© into home medicines review: a protocol for a cluster-randomised clinical trial in older adults.,"BACKGROUND


Older people living in the community have a high prevalence of polypharmacy and are vulnerable to adverse drug events. Home Medicines Review (HMR) is a collaborative medication review service involving general practitioners (GPs), accredited clinical pharmacists (ACPs) and patients, which aims to prevent medication-related problems. This study aims to evaluate the implementation of a Computerised Clinical Decision Support System (CCDSS) called G-MEDSS© (Goal-directed Medication Review Electronic Decision Support System) in HMRs to deprescribe anticholinergic and sedative medications, and to assess the effect of deprescribing on clinical outcomes.
METHODS


This study consists of 2 stages: Stage I - a two-arm parallel-group cluster-randomised clinical trial, and Stage II - process evaluation of the CCDSS intervention in HMR. Community-dwelling older adults living with and without dementia who are referred for HMR by their GP and recruited by ACPs will be included in this study. G-MEDSS is a CCDSS designed to provide clinical decision support for healthcare practitioners when completing a medication review, to tailor care to meet the patients' goals and preferences. The G-MEDSS contains three tools: The Goals of Care Management Tool, The Drug Burden Index (DBI) Calculator©, and The revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire. The G-MEDSS produces patient-specific deprescribing reports, to be included as part of the ACPs communication with the patient's GP, and patient-specific reports for the patient (or carer). ACPs randomised to the intervention arm of the study will use G-MEDSS to create deprescribing reports for the referring GP and for their patient (or carer) when submitting the HMR report. ACPs in the comparison arm will provide the usual care HMR service (without the G-MEDSS).
OUTCOMES


The primary outcome is reduction in DBI exposure 3 months after HMR ± G-MEDSS intervention between comparison and intervention groups. The secondary outcomes include changes in clinical outcomes (physical and cognitive function, falls, institutionalisation, GP visits, medication adherence and mortality) 3-months after HMR.
DISCUSSION


This study is expected to add to the evidence that the combination of CCDSS supporting medication review can improve prescribing and clinical outcomes in older adults.
TRIAL REGISTRATION


The trial was registered on the Australian New Zealand Clinical Trials Registry ACTRN12617000895381 on 19th June 2017.",2020,"This study aims to evaluate the implementation of a Computerised Clinical Decision Support System (CCDSS) called G-MEDSS© (Goal-directed Medication Review Electronic Decision Support System) in HMRs to deprescribe anticholinergic and sedative medications, and to assess the effect of deprescribing on clinical outcomes.
","['Community-dwelling older adults living with and without dementia who are referred for HMR by their GP and recruited by ACPs', 'older adults']","['CCDSS', 'Computerised Clinical Decision Support System (CCDSS) called G-MEDSS', 'G-MEDSS', 'CCDSS intervention']","['reduction in DBI exposure 3\u2009months after HMR\u2009±\u2009G-MEDSS intervention', 'changes in clinical outcomes (physical and cognitive function, falls, institutionalisation, GP visits, medication adherence and mortality) 3-months after HMR']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0049285', 'cui_str': 'deschlorobenzoylindomethacin'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.111559,"This study aims to evaluate the implementation of a Computerised Clinical Decision Support System (CCDSS) called G-MEDSS© (Goal-directed Medication Review Electronic Decision Support System) in HMRs to deprescribe anticholinergic and sedative medications, and to assess the effect of deprescribing on clinical outcomes.
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': ""Kouladjian O'Donnell"", 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia. lisa.kouladjian@sydney.edu.au.'}, {'ForeName': 'Mouna', 'Initials': 'M', 'LastName': 'Sawan', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Reeve', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Danijela', 'Initials': 'D', 'LastName': 'Gnjidic', 'Affiliation': 'Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Chen', 'Affiliation': 'Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Kelly', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'J Simon', 'Initials': 'JS', 'LastName': 'Bell', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Sarah N', 'Initials': 'SN', 'LastName': 'Hilmer', 'Affiliation': 'NHMRC Cognitive Decline Partnership Centre, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}]",BMC geriatrics,['10.1186/s12877-020-1442-2']
3199,32044871,FORGOT CALCIUM? ADMISSION IONIZED-CALCIUM IN TWO CIVILIAN RANDOMIZED CONTROLLED TRIALS OF PRE-HOSPITAL PLASMA FOR TRAUMATIC HEMORRHAGIC SHOCK.,"BACKGROUND


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


We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation. Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca<1.0mmol/L.
RESULTS


Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34). Pre-hospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Pre-hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03). Severe hypocalcemia was significantly associated with decreased survival(Adjusted Hazard Ratio:1.07;95%CI:1.02-1.13, p=0.01) and massive transfusion(aRR= 2.70;95%CI:1.13-6.46, p=0.03), after adjustment for confounders(randomization group, age, ISS, and shock index).
CONCLUSION


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


",2020,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","['Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm', 'Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34', 'We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation']",[],"['massive transfusion(aRR', 'Hypocalcemia', 'Severe hypocalcemia', 'rates of hypocalcemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.275164,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'Combat Casualty Care Research Program, US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'University of Colorado.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
3200,31749064,School-Based Treatment for Anxiety Research Study (STARS): a Randomized Controlled Effectiveness Trial.,"The current study compared the effectiveness of a school-clinician administered cognitive behavioral treatment (CBT) to treatment as usual (TAU) at post-treatment (i.e., after 12 weeks) and at a 1 year follow-up. Sixty-two school-based clinicians (37 in CBT; 25 in TAU) and 216 students (148 students in CBT; 68 in TAU) participated. Students were ages 6-18 (mean age 10.87; 64% Caucasian & 29% African American; 48.6% female) and all met DSM-IV diagnostic criteria for a primary anxiety disorder. Independent evaluators (IEs) assessed clinical improvement, global functioning, and loss of anxiety diagnoses; children and parents completed measures of anxiety symptoms. At post-treatment, no significant treatment main effects emerged on the primary outcome; 42% and 37% of youth were classified as treatment responders in CBT and TAU respectively. However, parent-report of child anxiety showed greater improvements in CBT relative to TAU (d = .29). Moderation analyses at post-treatment indicated that older youth, those with social phobia and more severe anxiety at baseline were more likely to be treatment responders in CBT compared to TAU. At the 1 year follow-up, treatment gains were maintained but no treatment group differences or moderators emerged. CBT and TAU for pediatric anxiety disorders, when delivered by school clinicians were generally similar in effectiveness for lowering anxiety and improving functioning at both post-treatment (on all but the parent measure and for specific subgroups) and 1 year follow-up. Implications for disseminating CBT in the school setting are discussed.",2020,"CBT and TAU for pediatric anxiety disorders, when delivered by school clinicians were generally similar in effectiveness for lowering anxiety and improving functioning at both post-treatment (on all but the parent measure and for specific subgroups) and 1 year follow-up.","['Sixty-two school-based clinicians (37 in CBT; 25 in TAU) and 216 students (148 students in CBT; 68 in TAU) participated', 'Students were ages 6-18 (mean age 10.87; 64% Caucasian & 29% African American; 48.6% female) and all met DSM-IV diagnostic criteria for a primary anxiety disorder']","['school-clinician administered cognitive behavioral treatment (CBT', 'CBT and TAU']","['severe anxiety', 'clinical improvement, global functioning, and loss of anxiety diagnoses; children and parents completed measures of anxiety symptoms']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0231403', 'cui_str': 'Severe anxiety (panic) (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.033446,"CBT and TAU for pediatric anxiety disorders, when delivered by school clinicians were generally similar in effectiveness for lowering anxiety and improving functioning at both post-treatment (on all but the parent measure and for specific subgroups) and 1 year follow-up.","[{'ForeName': 'Golda S', 'Initials': 'GS', 'LastName': 'Ginsburg', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, 65 Kane Street Room 2033, West Hartford, CT, 06119, USA. Gginsburg@uchc.edu.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Pella', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, 65 Kane Street Room 2033, West Hartford, CT, 06119, USA.'}, {'ForeName': 'Paige J', 'Initials': 'PJ', 'LastName': 'Pikulski', 'Affiliation': 'Department of Psychiatry, University of Connecticut School of Medicine, 65 Kane Street Room 2033, West Hartford, CT, 06119, USA.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Drake', 'Affiliation': 'Anxiety Treatment Center of Maryland, The Johns Hopkins Unviersity School of Medicine Baltimore, Baltimore, MD, 21205, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00596-5']
3201,32025883,Influence of ozone application in the stepwise excavation of primary molars: a randomized clinical trial.,"OBJECTIVES


The aim of this randomized, controlled, three-arm parallel-group, double-blinded clinical trial was to investigate the clinical and microbiological effects of the ozone application in stepwise excavation of primary molars.
MATERIALS AND METHODS


This study was conducted in in vivo conditions with 105 lower primary molars that had deep caries lesions. The teeth were randomly divided into three groups: (I) control group, conventional stepwise excavation with no disinfectants; (II) CHX (positive control) group, 2% chlorhexidine digluconate; and (III) experimental group, ozone application. Dentine samples were collected at 4 different time points (T0, at the first appointment, after partial removal of carious dentin; T1, at the first appointment, after applying disinfection procedure; T2, at the second appointment - at the end of the 4-month period - immediately after the removal of the temporary restoration; T3, at the second appointment, after the final excavation) for the microbiological analysis of mutans streptococci and lactobacilli and the total number of colony-forming units. Clinical changes including dentin color, humidity, and consistency were recorded. Data were analyzed using the Mann-Whitney U test, Friedman test, and chi-squared test (p = 0.05).
RESULTS


The dentin became harder and drier after 4 months in all the groups. There was a gradual reduction in the total number of microorganisms in all the three groups. Bacterial reduction was greater in the CHX group compared to the ozone group (p = 0.002) and was greater in the ozone group compared to the control group (p = 0.015) after 4 months (control, 78%; CHX, 93%; ozone, 82%).
CONCLUSION


Stepwise excavation of primary teeth provided successful outcomes in all the groups. Moreover, CHX, due to its practicality and cost-effectiveness, can be effectively used with one- or two-step indirect pulp therapies.
CLINICAL RELEVANCE


Usage of cavity disinfectants in the stepwise excavation procedure contributes to the reduction of bacterial population in the cavity, which may allow the avoidance of the second step of the indirect pulp therapy for primary teeth.",2020,"Bacterial reduction was greater in the CHX group compared to the ozone group (p = 0.002) and was greater in the ozone group compared to the control group (p = 0.015) after 4 months (control, 78%; CHX, 93%; ozone, 82%).
","['105 lower primary molars that had deep caries lesions', 'primary molars']","['ozone application', 'CHX', 'control group, conventional stepwise excavation with no disinfectants; (II) CHX (positive control) group, 2% chlorhexidine digluconate; and (III) experimental group, ozone application']","['Bacterial reduction', 'total number of microorganisms', 'dentin color, humidity, and consistency']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0333523', 'cui_str': 'Deep caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0012682', 'cui_str': 'Disinfectants'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0020167', 'cui_str': 'Humidity'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",105.0,0.0300688,"Bacterial reduction was greater in the CHX group compared to the ozone group (p = 0.002) and was greater in the ozone group compared to the control group (p = 0.015) after 4 months (control, 78%; CHX, 93%; ozone, 82%).
","[{'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Mese', 'Affiliation': 'Department of Pedodontics, Faculty of Dentistry, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Yesim Tuyji', 'Initials': 'YT', 'LastName': 'Tok', 'Affiliation': 'Department of Medical Microbiology, Atatürk Training and Research Hospital, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Selcuk', 'Initials': 'S', 'LastName': 'Kaya', 'Affiliation': 'Department of Medical Microbiology, Atatürk Training and Research Hospital, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Akcay', 'Affiliation': 'Department of Pedodontics, Faculty of Dentistry, Izmir Katip Celebi University, Izmir, Turkey. merve.akcay@ikc.edu.tr.'}]",Clinical oral investigations,['10.1007/s00784-020-03223-6']
3202,1829030,Changes in the plasma levels of proteins C and S in young women on low-dose oestrogen oral contraceptives.,"The physiological importance of proteins C and S as natural anticoagulants is demonstrated by the increased risk of thromboembolic disease among subjects with hereditary deficiency of both proteins. In the present study the effects were evaluated of low-dose oestrogen oral contraceptives (OC) on the plasma levels of immunological protein S, as free (PS-f), and in reversible complex with C4b-binding protein as well as functional protein C (PC) in a homogeneous group of 20 young healthy women. The participants were randomly given either gestodene (75 micrograms) or desogestrel (150 micrograms) in combination with ethinyl oestradiol (30 micrograms). Blood samples were taken prior to the initiation of the treatment and at the end of the sixth 21-day treatment cycle. The mean concentration of both free and bound PS fell significantly, the decrease still being within the reference range. Conversely, the plasma values for PC rose to a statistically significant extent. There were no significant differences between the two OCs. Hypothetically, the changes in PS-f (active fraction) might be conducive to a procoagulant state, which the increased PC may compensate. The reverse effect of two OCs on the activity of the protein C-protein S anticoagulant system might suggest a different regulation of their synthesis.",1991,There were no significant differences between the two OCs.,"['subjects with hereditary deficiency of both proteins', '20 young healthy women', 'young women on low-dose oestrogen oral contraceptives']","['gestodene', 'desogestrel (150 micrograms) in combination with ethinyl oestradiol', 'low-dose oestrogen oral contraceptives (OC']","['plasma values', 'mean concentration of both free and bound PS']","[{'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}]","[{'cui': 'C0061246', 'cui_str': 'Gestodene'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement (procedure)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception (finding)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}]",20.0,0.0158187,There were no significant differences between the two OCs.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Granata', 'Affiliation': 'Institute of Clinica Medica I, University of Messina, School of Medicine, Italy.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Sobbrio', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': ""D'Arrigo"", 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barillari', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'De Luca', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Egitto', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Granese', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pullè', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Trimarchi', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
3203,1829029,"Sex hormone binding globulin, cortisol binding globulin, thyroxine binding globulin, ceruloplasmin: changes in treatment with two oral contraceptives low in oestrogen.","It is generally assumed that the oral contraceptives cause the carrier proteins to change. Notoriously this effect is used to evaluate indirectly their estrogenicity/gestagenicity ratio. In order to assess the residual intrinsic androgenic activity of two new 19-nor-derivative components, Desogestrel (DG) 150 micrograms and Gestodene (GD) 75 micrograms, both in association with Ethinylestradiol (EE) 30 micrograms, Sex Hormone Binding Globulin, Thyroxine Binding Globulin, Ceruloplasmin and Free Androgen Index (FAI), were studied in 40 young normally cycling healthy volunteers, matched for body mass index and age. The participants were randomly assigned to either EE-DG or EE-GD treatment. A marked significant increase in all the carrier proteins was found. Conversely, the values for FAI decreased significantly. The changes in the two groups were substantially of the same magnitude. These results are an indirect confirmation of the well-known negligible receptor binding affinity of the two progestogen in vitro, also supporting for these compounds the lack of relevant androgenic effects.",1991,The changes in the two groups were substantially of the same magnitude.,"['40 young normally cycling healthy volunteers, matched for body mass index and age']","['EE-DG or EE-GD treatment', 'Ethinylestradiol (EE) 30 micrograms, Sex Hormone Binding Globulin, Thyroxine Binding Globulin, Ceruloplasmin and Free Androgen Index (FAI', 'Desogestrel (DG) 150 micrograms and Gestodene (GD']","['carrier proteins', 'values for FAI', 'residual intrinsic androgenic activity']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0087090', 'cui_str': 'Thyropexin'}, {'cui': 'C0007841', 'cui_str': 'Ceruloplasmin Ferroxidase'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0061246', 'cui_str': 'Gestodene'}]","[{'cui': 'C0007292', 'cui_str': 'Transport Proteins'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",40.0,0.0238073,The changes in the two groups were substantially of the same magnitude.,"[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Sobbrio', 'Affiliation': 'University of Messina, School of Medicine, Institute of Clinica Medica I, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Granata', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Granese', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': ""D'Arrigo"", 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Panacea', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nicita', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pullè', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Trimarchi', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
3204,32070647,The Feasibility of the Ultrasound-Guided Femoral Nerve Block Procedure with Low-Dose Local Anesthetic in Intracapsular and Extracapsular Hip Fractures.,"BACKGROUND


The local anesthetic dosages used in the current literature in regional applications of local anesthetics are frequently high for surgical purposes, and there are no sufficient dosage studies for emergency department (ED) management.
OBJECTIVES


The aim of this study was to determine the success of lower local anesthetic dosages capable of reducing costs and excessive exposure to drugs in pain control in patients with femoral neck fractures (FNFs) in the ED.
METHODS


Patients ≥65 years of age with FNFs and reporting Wong-Baker Pain Rating Scales scores ≥8 were included in this prospective, interventional study. Patients underwent ultrasound-guided regional femoral block with 5 mL 2% prilocaine. Pain scores before the procedure and at 30 min and 2 h postprocedure were compared with the Friedman test and Wilcoxon test with Bonferroni correction.
RESULTS


Forty patients, 20 with intracapsular and 20 with extracapsular FNFs, were enrolled. The initial pain scores of patients with both intra- and extracapsular fractures were 8 (range 8-10). A statistically significant 50% decrease in pain scores was observed in both groups 30 min after the regional block procedure (p < 0.001). A statistically significant 75% decrease in pain scores was observed in both groups 2 h after the regional block procedure (p < 0.001). No statistically significant difference was determined in the change in 30-min and 2-h pain scores between the groups.
CONCLUSIONS


The administration of 5 mL 2% prilocaine for pain control in FNFs in elderly patients in the ED can reduce systemic analgesic requirements by establishing effective analgesia in both intracapsular and extracapsular fractures.",2020,"No statistically significant difference was determined in the change in 30-min and 2-h pain scores between the groups.
","['Intracapsular and Extracapsular Hip Fractures', 'Forty patients, 20 with intracapsular and 20 with extracapsular FNFs, were enrolled', 'patients with femoral neck fractures (FNFs', 'elderly patients', 'Patients ≥65\xa0years of age with FNFs and reporting Wong-Baker Pain Rating Scales scores ≥8']","['prilocaine', 'Ultrasound-Guided Femoral Nerve Block Procedure with Low-Dose Local Anesthetic', 'ultrasound-guided regional femoral block with 5\xa0mL 2% prilocaine']","['change in 30-min and 2-h pain scores', 'initial pain scores', 'pain scores', 'systemic analgesic requirements', 'Pain scores']","[{'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.0603779,"No statistically significant difference was determined in the change in 30-min and 2-h pain scores between the groups.
","[{'ForeName': 'Fatih Esad', 'Initials': 'FE', 'LastName': 'Topal', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Bilgin', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Yamanoglu', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Karakaya', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Payza', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Pınar Yesim', 'Initials': 'PY', 'LastName': 'Akyol', 'Affiliation': 'Department of Emergency Medicine, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Aslan', 'Affiliation': 'Department of Orthopaedics and Traumatology, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Aksun', 'Affiliation': 'Department of Anesthesiology, Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2019.12.033']
3205,32071367,Optimizing individual nutrition in preterm very low birth weight infants: double-blinded randomized controlled trial.,"OBJECTIVE


In preterm neonates fed human milk, fortification may be adjusted by (1) optimization, based on growth rate and serum nutrient analyses, or (2) individualization, based on serial milk nutrient analyses. The primary aim was to determine whether individualized plus optimized nutrition (experimental) improves velocity of weight gain and linear growth from birth to endpoint (36 weeks postmenstrual age or discharge) when compared with optimized nutrition alone (controls).
STUDY DESIGN


Double-blinded parallel group randomized trial in 120 neonates <29 weeks gestational age (GA) or <35 weeks and small for GA (birth weight < 10th centile).
RESULT


Weight-gain velocity (13.1 ± 2.1, n = 57 controls, vs. 13.0 ± 2.6 g kg -1  day -1 , n = 59 experimental, P = 0.87), linear growth (0.9 ± 0.2, n = 55, vs. 0.9 ± 0.2 cm week -1 , n = 52, P = 0.90) and frequency of weight/length disproportion (2% vs. 2%, P = 0.98) were similar in both groups.
CONCLUSIONS


Individualized plus optimized nutrition does not improve weight gain, linear growth, or weight/length disproportion at endpoint versus optimized nutrition alone.",2020,"Individualized plus optimized nutrition does not improve weight gain, linear growth, or weight/length disproportion at endpoint versus optimized nutrition alone.","['preterm very low birth weight infants', '120 neonates <29 weeks gestational age (GA) or <35 weeks and small for GA (birth weight\u2009<\u200910th centile']","['optimized nutrition alone (controls', 'individualized plus optimized nutrition (experimental']","['weight gain, linear growth, or weight/length disproportion', 'velocity of weight gain and linear growth', 'frequency of weight/length disproportion', 'Weight-gain velocity']","[{'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",120.0,0.444572,"Individualized plus optimized nutrition does not improve weight gain, linear growth, or weight/length disproportion at endpoint versus optimized nutrition alone.","[{'ForeName': 'Luc P', 'Initials': 'LP', 'LastName': 'Brion', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, TX, USA. luc.brion@utsouthwestern.edu.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Rosenfeld', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Heyne', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'L Steven', 'Initials': 'LS', 'LastName': 'Brown', 'Affiliation': 'Parkland Health & Hospital System, Dallas, TX, USA.'}, {'ForeName': 'Cheryl S', 'Initials': 'CS', 'LastName': 'Lair', 'Affiliation': 'Parkland Health & Hospital System, Dallas, TX, USA.'}, {'ForeName': 'Elen', 'Initials': 'E', 'LastName': 'Petrosyan', 'Affiliation': 'Parkland Health & Hospital System, Dallas, TX, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Jacob', 'Affiliation': 'Parkland Health & Hospital System, Dallas, TX, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Caraig', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Patti J', 'Initials': 'PJ', 'LastName': 'Burchfield', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, TX, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0609-1']
3206,31945895,STAR-Liège Clinical Trial Interim Results: Safe and Effective Glycemic Control for All.,"While the benefits of glycemic control for critically ill patients are increasingly demonstrated, the ability to deliver safe, effective control to intermediate target ranges is widely debated due to the increased risk of hypoglycemia. This study analyzes interim clinical trial results of the fully computerized model-based Stochastic TARgeted (STAR) glycemic control framework at the University Hospital of Liège, Belgium. Patients with dysglycemia were randomly assigned to the full version of STAR, modulating both insulin and nutrition inputs, or STAR-IO, an insulin only version of STAR. Both arms target the normoglycemic 80-145 mg/dL (4.4-8.0 mmol/L) band. Results are further compared to retrospective data from 20 patients under the standard unit protocol targeting a higher 100-150 mg/dL (5.6-8.3 mmol/L) band. Much higher time in target band is provided under the full version of STAR, with similar safety and significantly lower incidence of mild hyperglycemia (blood glucose > 145 mg/dL or 8.0 mmol/L) and severe hyperglycemia (blood glucose > 180 mg/dL or 10.0 mmol/L). As a result, lower median blood glucose levels are safely and consistently achieved with lower glycemic variability, suggesting STAR's potential to improve clinical outcomes. These interim results show the possibility to achieve safe, effective control for all patients using STAR, and suggest glycemic control to lower targets could be beneficial.",2019,"Much higher time in target band is provided under the full version of STAR, with similar safety and significantly lower incidence of mild hyperglycemia (blood glucose > 145 mg/dL or 8.0 mmol/L) and severe hyperglycemia (blood glucose > 180 mg/dL or 10.0 mmol/L).","['Patients with dysglycemia', 'critically ill patients']","['fully computerized model-based Stochastic TARgeted (STAR) glycemic control framework', 'full version of STAR, modulating both insulin and nutrition inputs, or STAR-IO, an insulin only version of STAR']","['median blood glucose levels', 'Safe and Effective Glycemic Control', 'mild hyperglycemia (blood glucose', 'severe hyperglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1960636', 'cui_str': 'Dysglycemia'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0009609', 'cui_str': 'Computerized Models'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0199933,"Much higher time in target band is provided under the full version of STAR, with similar safety and significantly lower incidence of mild hyperglycemia (blood glucose > 145 mg/dL or 8.0 mmol/L) and severe hyperglycemia (blood glucose > 180 mg/dL or 10.0 mmol/L).","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Uyttendaele', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Knopp', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Pirotte', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Morimont', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Lambermont', 'Affiliation': ''}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Shaw', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Desaive', 'Affiliation': ''}, {'ForeName': 'J Geoffrey', 'Initials': 'JG', 'LastName': 'Chase', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2019.8856303']
3207,31556937,Effects of Flavanol-Rich Dark Chocolate on Visual Function and Retinal Perfusion Measured With Optical Coherence Tomography Angiography: A Randomized Clinical Trial.,"Importance


A recently reported randomized clinical trial suggested beneficial effects of vasodilating flavanols in dark chocolate on visual function without objective quantification of retinal perfusion.
Objective


To assess the effects of dark chocolate flavanols on subjective visual function and retinal perfusion objectively quantified on optical coherence tomography (OCT) angiography.
Design, Setting, and Participants


This randomized, masked double-blind crossover clinical trial analyzed 22 healthy participants at the Department of Ophthalmology, Ludwig Maximilians-University Munich, Germany, in July 2018. Analysis was intention to treat. Analysis began in July 2018.
Interventions


Participants were randomized to consume 20 g of dark chocolate containing 400 mg of flavanols or 7.5 g of milk chocolate. Two hours later, visual function and retinal perfusion on OCT angiography were evaluated. Systemic blood pressure was measured to rule out artifacts on OCT angiography.
Main Outcomes and Measures


The primary end point was macular retinal perfusion quantified as vessel density on OCT angiography. The secondary end point was subjective visual function (Early Treatment Diabetic Retinopathy Study visual acuity, Pelli-Robson chart, and Mars chart contrast sensitivity).
Results


All 22 participants (13 women [59.1%]; mean [SD] age, 27.3 [11.1] years) completed the trial. No relevant differences in baseline parameters between groups were identified. No change in the primary outcome measure, retinal perfusion, could be detected after consumption of dark vs milk chocolate (superficial plexus 48.0% vs 47.5%, treatment effect: -0.59 [95% CI, -2.68 to 1.50], P = .56; deep plexus 54.1% vs 54.0%, treatment effect: -1.14 [95% CI, -4.01 to 1.73], P = .42). No differences in changes in the secondary outcome parameters Early Treatment Diabetic Retinopathy Study visual acuity, Pelli-Robson chart, or Mars chart contrast sensitivity could be detected. Potentially confounding effects of changes in blood pressure were excluded.
Conclusions and Relevance


In contrast to a previous similarly sized randomized clinical trial reporting beneficial effects on visual function, no short-term effects of flavanol-rich dark chocolate on automatically assessed retinal blood flow on OCT angiography or subjective visual function were observed in this study. As this small trial does not rule out the possibility of benefits, further trials with larger sample sizes would be needed to rule in or out possible long-term benefits confidently.
Trial Registration


German Clinical Trials Register identifier: DRKS0001506.",2019,"No change in the primary outcome measure, retinal perfusion, could be detected after consumption of dark vs milk chocolate (superficial plexus 48.0% vs 47.5%, treatment effect: -0.59 [95% CI, -2.68 to 1.50], P = .56; deep plexus 54.1% vs 54.0%, treatment effect: -1.14 [95% CI, -4.01 to 1.73], P = .42).","['All 22 participants (13 women [59.1%]; mean [SD] age, 27.3 [11.1] years) completed the trial', '22 healthy participants at the Department of Ophthalmology, Ludwig Maximilians-University Munich, Germany, in July 2018']","['vasodilating flavanols', 'consume 20 g of dark chocolate containing 400 mg of flavanols or 7.5 g of milk chocolate', 'Optical Coherence Tomography Angiography', 'flavanol-rich dark chocolate', 'Flavanol-Rich Dark Chocolate', 'dark chocolate flavanols']","['visual function and retinal perfusion on OCT angiography', 'Systemic blood pressure', 'macular retinal perfusion quantified as vessel density on OCT angiography', 'Diabetic Retinopathy Study visual acuity, Pelli-Robson chart, or Mars chart contrast sensitivity', 'blood pressure', 'Visual Function and Retinal Perfusion', 'consumption of dark vs milk chocolate', 'retinal blood flow on OCT angiography or subjective visual function', 'retinal perfusion', 'subjective visual function', 'subjective visual function (Early Treatment Diabetic Retinopathy Study visual acuity, Pelli-Robson chart, and Mars chart contrast sensitivity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C3853217', 'cui_str': 'Dark chocolate (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0453437', 'cui_str': 'Milk chocolate (substance)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}, {'cui': 'C0453437', 'cui_str': 'Milk chocolate (substance)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",22.0,0.498951,"No change in the primary outcome measure, retinal perfusion, could be detected after consumption of dark vs milk chocolate (superficial plexus 48.0% vs 47.5%, treatment effect: -0.59 [95% CI, -2.68 to 1.50], P = .56; deep plexus 54.1% vs 54.0%, treatment effect: -1.14 [95% CI, -4.01 to 1.73], P = .42).","[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Siedlecki', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Mohr', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Luft', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Schworm', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Keidel', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Siegfried G', 'Initials': 'SG', 'LastName': 'Priglinger', 'Affiliation': 'Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.3731']
3208,31356561,Effect of the infusion rate of propofol on the onset time of rocuronium.,"BACKGROUND


Administration of propofol, especially rapid administration, decreases patient cardiac output (CO) to various degrees. CO might influence the buildup of an effective drug level within the neuromuscular junction and affect the onset time of neuromuscular blockers. The present study aimed to investigate the effects of different infusion rates of propofol on patient CO and the onset time of rocuronium.
METHODS


A total of 90 patients were randomly assigned to receive propofol (2.5 mg/kg) at an infusion rate of 480 mg/min (group A), 240 mg/min (group B), or 120 mg/min (group C). After the administration of propofol, rocuronium (0.6 mg/kg) was administered to facilitate tracheal intubation. The Finometer monitor was used to obtain the cardiovascular profile during the induction of general anesthesia. Neuromuscular relaxation was monitored by acceleromyography using the ulnar nerve at the wrist surface and electrodes with repeated single twitches. Onset time was defined as the time from the beginning of rocuronium injection until 95% twitch depression. The onset time of rocuronium in the three groups was compared using analysis of variance with the post-hoc Tukey test. A p-value <0.05 was considered statistically significant.
RESULTS


After induction, a significant decrease in CO was observed in group A (21.6% ± 4.6%) when compared with the findings in group B (11.6% ± 4.5%) and group C (9.8% ± 4.6%). The onset time of rocuronium was significantly longer in group A (177.7 ± 17.6 seconds) than in group B (121.3 ± 18.3 seconds) and group C (118.3 ± 12.3 seconds).
CONCLUSION


Rapid administration of propofol significantly delays the onset time of rocuronium by altering CO as measured with the Finometer monitor.",2019,"The onset time of rocuronium was significantly longer in group A (177.7 ± 17.6 seconds) than in group B (121.3 ± 18.3 seconds) and group C (118.3 ± 12.3 seconds).
",['A total of 90 patients'],"['propofol, rocuronium', 'propofol']","['CO', 'onset time of rocuronium', 'Neuromuscular relaxation', 'patient cardiac output (CO']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]","[{'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}]",90.0,0.0591879,"The onset time of rocuronium was significantly longer in group A (177.7 ± 17.6 seconds) than in group B (121.3 ± 18.3 seconds) and group C (118.3 ± 12.3 seconds).
","[{'ForeName': 'Chia-Shiang', 'Initials': 'CS', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Mackay Memorial Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chien-Chuan', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Mackay Memorial Hospital, Taipei, Taiwan, ROC.'}, {'ForeName': 'Yung-Wei', 'Initials': 'YW', 'LastName': 'Hsu', 'Affiliation': 'Department of Anesthesiology, Mackay Memorial Hospital, Taipei, Taiwan, ROC.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000147']
3209,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3210,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3211,32039987,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"MINI: In this randomized clinical trial to prevent anastomotic recurrence in Crohn disease, the new Kono-S anastomosis demonstrates a significant reduction in postoperative clinical and endoscopic recurrence rates after ileocolic surgery than conventional side-to-side anastomosis and no safety issues.
OBJECTIVE


This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND


Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS


Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS


In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS


This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[""Crohn's Disease"", '79 ileocolic CD patients']","['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis', 'MINI']","['SR rate', 'longer time until CR', 'postoperative outcomes', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'endoscopic recurrence (ER) ', 'postoperative clinical and endoscopic recurrence rates', 'severe postoperative ER', 'endoscopic recurrence score and surgical recurrence rate', 'clinical recurrence (CR', 'reduced risk of ER', 'surgical recurrence (SR']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0677619', 'cui_str': 'Side-to-side anastomosis (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",79.0,0.165843,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
3212,31246057,Emotional processing of trauma narratives is a predictor of outcome in emotion-focused therapy for complex trauma.,"This study tested a model of emotional processes over the course of emotion-focused therapy for trauma. The model of emotional processing (Pascual-Leone & Greenberg, 2007) proposes a sequential order of shifting from ""early expressions of distress"" to ""primary adaptive emotion"" that aid in adaptive functioning. Thirty-eight participants were taken from a randomized clinical trial to examine in-session process from video recordings of treatment. The sample had an average age ( M  = 44.3 years) and the majority was female (55.3%) and of European descent (89.5%). The Classification of Affective Meaning States was used to examine changes in emotional processes during trauma narratives in both early and late sessions. Processes were related to treatment outcome as measured by the Impact of Event Scale and the Resolution Scale. Sessions later in treatment showed a higher frequency of primary adaptive emotions compared with early sessions ( p  < .001,  r  = .76). Primary adaptive emotions were also more frequent in good-outcome cases ( p  = .017). Using emotional processes as predictors correctly classified 67% of poor-outcome cases and 80% of good-outcome cases. Increases in primary adaptive emotions from early to late treatment sessions more than doubled the odds (2.2) of having a good treatment outcome. The order of emotion was concordant with the sequential model in early sessions and partially concordant in late sessions. Findings have implications for guiding therapeutic process in a productive manner that leads to trauma recovery. Changes in discrete emotions were related to good treatment outcome. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Sessions later in treatment showed a higher frequency of primary adaptive emotions compared with early sessions ( p  < .001,  r  = .76).","['Thirty-eight participants', 'The sample had an average age ( M  = 44.3 years) and the majority was female (55.3%) and of European descent (89.5']","['emotional processing (Pascual-Leone & Greenberg, 2007) proposes a sequential order of shifting from ""early expressions of distress"" to ""primary adaptive emotion"" that aid in adaptive functioning']","['frequency of primary adaptive emotions', 'Impact of Event Scale and the Resolution Scale', 'discrete emotions', 'primary adaptive emotions']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0451226', 'cui_str': 'Impact of event scale (assessment scale)'}, {'cui': 'C0222045'}]",38.0,0.0205918,"Sessions later in treatment showed a higher frequency of primary adaptive emotions compared with early sessions ( p  < .001,  r  = .76).","[{'ForeName': 'Ula', 'Initials': 'U', 'LastName': 'Khayyat-Abuaita', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Paivio', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pascual-Leone', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Harrington', 'Affiliation': 'Department of Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000238']
3213,32028859,The impact of alliance-focused and facilitative interpersonal relationship training on therapist skills: An RCT of brief training.,"Research on standard methods of therapist training has found mixed evidence to as to whether standard training methods are effective. This study investigated the impact of a novel, research-informed training protocol that integrated elements of alliance-focused training (AFT) and facilitative interpersonal skills (FIS). Beyond traditional training techniques of didactics and lecture, the AFT/FIS intervention incorporated empirically supported video simulations of therapy, which were reinforced by role plays and deliberate practice on key therapeutic interpersonal skills. Fifty-eight graduate-level therapy trainees and professional therapists from various helping fields were randomized to one of two brief trainings in a multi-site RCT: (i) the AFT/FIS workshop or (ii) a more traditional demonstration training (DT) workshop. Participants were assessed on critical, relational therapeutic skills before and after the training. After controlling for relevant covariates, participants in the AFT/FIS training saw a marginally higher post-intervention level of overall therapeutic skills. Subsequent exploratory analyses revealed AFT/FIS participants also had significantly higher levels of specifically targeted post-training therapist skills (i.e., empathy, alliance bond capacity, and alliance rupture-repair responsiveness) compared to participants in DT. Implications for future empirical investigations and training initiatives are discussed.",2020,"Subsequent exploratory analyses revealed AFT/FIS participants also had significantly higher levels of specifically targeted post-training therapist skills (i.e., empathy, alliance bond capacity, and alliance rupture-repair responsiveness) compared to participants in DT.",['Fifty-eight graduate-level therapy trainees and professional therapists from various helping fields'],"['facilitative interpersonal relationship training', 'alliance-focused training (AFT) and facilitative interpersonal skills (FIS', 'therapist training', 'AFT/FIS workshop or (ii) a more traditional demonstration training (DT) workshop', 'RCT']","['post-intervention level of overall therapeutic skills', 'levels of specifically targeted post-training therapist skills (i.e., empathy, alliance bond capacity, and alliance rupture-repair responsiveness']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0440042', 'cui_str': ""Field's""}]","[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]",58.0,0.0337088,"Subsequent exploratory analyses revealed AFT/FIS participants also had significantly higher levels of specifically targeted post-training therapist skills (i.e., empathy, alliance bond capacity, and alliance rupture-repair responsiveness) compared to participants in DT.","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Perlman', 'Affiliation': 'Psychology, Ohio University, Athens, OH, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Psychology, Ohio University, Athens, OH, USA.'}, {'ForeName': 'Victoria K', 'Initials': 'VK', 'LastName': 'Foley', 'Affiliation': 'Psychology, The New School for Social Research, New York, NY, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Mimnaugh', 'Affiliation': 'Psychology, The New School for Social Research, New York, NY, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Safran', 'Affiliation': 'Psychology, The New School for Social Research, New York, NY, USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1722862']
3214,32030497,Long-term outcome after thrombus aspiration in non-ST-elevation myocardial infarction: results from the TATORT-NSTEMI trial : Thrombus aspiration in acute myocardial infarction.,"AIMS


To investigate the long-term prognostic value of aspiration thrombectomy in conjunction with primary percutaneous coronary intervention (PCI) compared to conventional PCI in patients with non-ST-elevation myocardial infarction (NSTEMI).
METHODS


In the randomized TATORT-NSTEMI (Thrombus aspiration in thrombus containing culprit lesions in non-ST-elevation myocardial infarction) trial, NSTEMI patients with thrombus containing culprit lesions were randomized to either PCI with aspiration thrombectomy or conventional PCI. The endpoint was a combination of all-cause death, reinfarction and new congestive heart failure.
RESULTS


From 440 patients initially randomized, outcome data were available in 432 (98.2%) patients at a median follow-up of 4.9 (interquartile range [IQR] 4.4-5.0) years. Thrombectomy was associated with a significant reduction of the combined endpoint compared to conventional PCI (19.9% vs. 30.7%, p = 0.01). This finding was primarily driven by a reduced rate of reinfarction with thrombectomy (3.4% vs. 10.3%, p = 0.01). Thrombectomy was still independently associated with the combined endpoint after multivariable adjustment (hazard ratio [HR] 0.47, 95% confidence interval [CI] 0.30-0.76, p = 0.002). Findings were consistent across all analyzed subgroups (p values for interaction all > 0.05).
CONCLUSIONS


In NSTEMI, thrombus aspiration is associated with favorable clinical outcome during long-term follow-up.
CLINICAL TRIAL REGISTRATION


NCT01612312.",2020,"Thrombectomy was associated with a significant reduction of the combined endpoint compared to conventional PCI (19.9% vs. 30.7%, p = 0.01).","['patients with non-ST-elevation myocardial infarction (NSTEMI', 'patients with thrombus containing culprit lesions', 'non-ST-elevation myocardial infarction']","['conventional PCI', 'thrombus aspiration', 'aspiration thrombectomy in conjunction with primary percutaneous coronary intervention (PCI', 'PCI with aspiration thrombectomy or conventional PCI']","['rate of reinfarction with thrombectomy', 'combination of all-cause death, reinfarction and new congestive heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4255010', 'cui_str': 'Non-ST-Elevation Myocardial Infarction'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C4045995', 'cui_str': 'Aspiration Thrombectomy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}]",440.0,0.206671,"Thrombectomy was associated with a significant reduction of the combined endpoint compared to conventional PCI (19.9% vs. 30.7%, p = 0.01).","[{'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Strümpellstr. 39, 04289, Leipzig, Germany.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Meyer-Saraei', 'Affiliation': 'Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Lober', 'Affiliation': 'Institut für Herzinfarktforschung GmbH, IHF, Ludwigshafen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III, University of Saarland, Homburg, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scheller', 'Affiliation': 'Department of Internal Medicine III, University of Saarland, Homburg, Germany.'}, {'ForeName': 'Bernward', 'Initials': 'B', 'LastName': 'Lauer', 'Affiliation': 'Department of Cardiology, University Hospital Jena, Jena, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Geisler', 'Affiliation': 'Department of Cardiology/Cardiovascular Medicine, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Meinrad', 'Initials': 'M', 'LastName': 'Gawaz', 'Affiliation': 'Department of Cardiology/Cardiovascular Medicine, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Leonhard', 'Initials': 'L', 'LastName': 'Bruch', 'Affiliation': 'Department of Internal Medicine, Unfallkrankenhaus Berlin, Berlin, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Klein', 'Affiliation': 'Klinik für Kardiologie und Internistische Intensivmedizin, Klinikum St. Georg, Leipzig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut für Herzinfarktforschung GmbH, IHF, Ludwigshafen, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jobs', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Strümpellstr. 39, 04289, Leipzig, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Freund', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Strümpellstr. 39, 04289, Leipzig, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Strümpellstr. 39, 04289, Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Strümpellstr. 39, 04289, Leipzig, Germany. Holger.Thiele@medizin.uni-leipzig.de.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01613-0']
3215,32037084,"Effect of a Nutritional Intervention, Based on Transtheoretical Model, on Metabolic Markers and Food Consumption of Individuals Undergoing Hemodialysis.","OBJECTIVE


This study aimed to evaluate the effect of a nutritional intervention, based on the transtheoretical model, on the metabolic markers and dietary intake of individuals undergoing hemodialysis (HD).
METHODS


Intervention study at a nephrology clinic includes 83 individuals undergoing HD, over a period of 4 months. The nutritional intervention based on the transtheoretical model was composed of two group meetings and three individual ones, with delivery of personalized food plans and nutritional education activities. Anthropometry, dietary intake, metabolic markers, and stage of behavior change were evaluated before and after nutritional intervention.
RESULTS


There was a significant change from the stage of contemplation to the stage of action, after the intervention (P < .001). There was a significant reduction in serum concentrations of creatinine and predialysis and postdialysis urea (P < .001). Hyperphosphataemia and hyperkalemia in the group were also significantly reduced as were markers related to bone metabolism (P < .001). The markers of iron metabolism (P < .001), protein (P = .042), and globulin (P < .001) showed a significant increase. Regarding food consumption, the caloric intakes (P = .034), cholesterol (P = .034), protein, and lipid as well as intake of iron, phosphorus, potassium, copper, and vitamin C (P < .001) were significantly higher after intervention.
CONCLUSIONS


The nutritional intervention based on the transtheoretical model promoted a change in the behavior of individuals undergoing HD, with an important improvement in their metabolic control. This can be explained by the significant change in the intake of calories, macronutrients, and micronutrients, as well as adequate use of phosphorus binders, indicating the crucial role of nutrition in this group.",2020,"Regarding food consumption, the caloric intakes (P = .034), cholesterol (P = .034), protein, and lipid as well as intake of iron, phosphorus, potassium, copper, and vitamin C (P ","['Intervention study at a nephrology clinic includes 83 individuals undergoing HD, over a period of 4\xa0months', 'individuals undergoing hemodialysis (HD', 'Individuals Undergoing Hemodialysis']","['nutritional intervention', 'Nutritional Intervention']","['bone metabolism', 'Anthropometry, dietary intake, metabolic markers, and stage of behavior change', 'serum concentrations of creatinine and predialysis and postdialysis urea', 'Hyperphosphataemia and hyperkalemia', 'stage of contemplation to the stage of action', 'caloric intakes', 'markers of iron metabolism', 'protein, and lipid as well as intake of iron, phosphorus, potassium, copper, and vitamin C (P']","[{'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C3814531', 'cui_str': 'Nephrology clinic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]",[],"[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker (substance)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemias'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]",83.0,0.0147012,"Regarding food consumption, the caloric intakes (P = .034), cholesterol (P = .034), protein, and lipid as well as intake of iron, phosphorus, potassium, copper, and vitamin C (P ","[{'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Vaz de Melo Ribeiro', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Minas Gerais, Brazil. Electronic address: priscilavazdemelo@yahoo.com.br.'}, {'ForeName': 'Helen Hermana', 'Initials': 'HH', 'LastName': 'Miranda Hermsdorff', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Minas Gerais, Brazil.'}, {'ForeName': 'Karla Pereira', 'Initials': 'KP', 'LastName': 'Balbino', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Minas Gerais, Brazil.'}, {'ForeName': 'Andreza', 'Initials': 'A', 'LastName': 'de Paula Santos Epifânio', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Minas Gerais, Brazil.'}, {'ForeName': 'Mônica', 'Initials': 'M', 'LastName': 'de Paula Jorge', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Minas Gerais, Brazil.'}, {'ForeName': 'Ana Vládia', 'Initials': 'AV', 'LastName': 'Bandeira Moreira', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Minas Gerais, Brazil.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2019.12.004']
3216,32031665,Ixekizumab treatment of biologic-naïve patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1).,"OBJECTIVE


The aim was to assess the safety and efficacy of up to 156 weeks of ixekizumab (an IL-17A antagonist) treatment in PsA patients.
METHODS


In a phase III study, patients naïve to biologic treatment were randomized to placebo, adalimumab 40 mg every 2 weeks (ADA; active reference) or ixekizumab 80 mg every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) after an initial dose of 160 mg. At week 24 (week 16 for inadequate responders), ADA (after 8-week washout) and placebo patients were re-randomized to IXEQ2W or IXEQ4W. Outcomes were evaluated using a modified non-responder imputation [linear extrapolation for radiographic progression (modified total Sharp score = 0)] during extended treatment until week 156.
RESULTS


Of 417 patients, 381 entered the extension, and 243 of 381 (63.8%) completed the 156-week study. Incidence rates of treatment-emergent and serious adverse events, respectively, were 38.0 and 5.2 with IXEQ2W (n = 189) and 38.1 and 8.0 with IXEQ4W (n = 197). One death occurred (IXEQ4W). With IXEQ2W and IXEQ4W, respectively, the response rates persisted to week 156 as measured by the ACR response ≥20% (62.5 and 69.8%), ≥50% (56.1 and 51.8%) and ≥70% (43.8 and 33.4%), psoriasis area and severity index (PASI) 75 (69.1 and 63.5%), PASI 90 (64.5 and 51.2%) and PASI 100 (60.5 and 43.6%). Inhibition of radiographic progression also persisted to week 156 in 61% of IXEQ2W and 71% of IXEQ4W patients.
CONCLUSION


In this 156-week study of ixekizumab, the safety profile remained consistent with previous reports, and improvements in signs and symptoms of PsA were observed, including persistent low rates of radiographic progression.
TRIAL REGISTRATION


ClinicalTrials.gov, http://clinicaltrials.gov, NCT01695239, EudraCT 2011-002326-49.",2020,"Inhibition of radiographic progression also persisted to week 156 in 61% of IXEQ2W and 71% of IXEQ4W patients.
","['biologic-naïve patients with active psoriatic arthritis', 'PsA patients', ' 381 entered the extension, and 243 of 381 (63.8%) completed the 156-week study', '417 patients', 'patients naïve to biologic treatment']","['placebo', 'Ixekizumab', 'placebo, adalimumab 40\u2009mg every 2\u2009weeks (ADA; active reference) or ixekizumab 80\u2009mg every 2\u2009weeks (IXEQ2W) or every 4\u2009weeks (IXEQ4W', 'ixekizumab']","['response rates', 'psoriasis area and severity index', 'Inhibition of radiographic progression', 'safety and efficacy', 'One death occurred (IXEQ4W', 'Incidence rates of treatment-emergent and serious adverse events']","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C4708787', 'cui_str': '381 (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1275555', 'cui_str': 'q4wk'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.13628,"Inhibition of radiographic progression also persisted to week 156 in 61% of IXEQ2W and 71% of IXEQ4W patients.
","[{'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Chandran', 'Affiliation': 'Division of Rheumatology, Department of Medicine, University of Toronto, ON, Canada.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Fleischmann', 'Affiliation': 'Metroplex Clinical Research Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lespessailles', 'Affiliation': 'Department of Rheumatology CHR Orléans, University of Orléans, Orléans, France.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Helliwell', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Department of Internal Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Burgos-Vargas', 'Affiliation': 'Department of Rheumatology, Hospital General de Mexico, Mexico City, Mexico.'}, {'ForeName': 'Janelle S', 'Initials': 'JS', 'LastName': 'Erickson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Suchitrita S', 'Initials': 'SS', 'LastName': 'Rathmann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Aubrey Trevelin', 'Initials': 'AT', 'LastName': 'Sprabery', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Birt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Shuler', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez684']
3217,1790601,A randomized comparative study for the clinical evaluation of hormone replacement by transdermal and oral routes.,"During a six-month randomized study involving 460 post-menopausal women, transdermal estradiol has proved to be as effective as oral conjugated equine estrogens in the control of menopausal symptoms and to produce similar estrogenic effects on the endometrium. The group of patients treated with transdermal estradiol showed better compliance and had fewer drop-outs. Moreover, the quality and duration of menstrual bleeding were considered more physiological in the transdermal estradiol group than in the orally treated patients. The trial was carried out with the co-operation of 17 Italian University Centres, under the supervision of Ciba-Geigy Italy S.p.A. Medical Department.",1991,The group of patients treated with transdermal estradiol showed better compliance and had fewer drop-outs.,"['17 Italian University Centres, under the supervision of Ciba-Geigy Italy S.p.A. Medical Department', '460 post-menopausal women']","['transdermal estradiol', 'hormone replacement by transdermal and oral routes']",['quality and duration of menstrual bleeding'],"[{'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0587450', 'cui_str': 'Medical department (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1527415', 'cui_str': 'Per oral route'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",460.0,0.0345717,The group of patients treated with transdermal estradiol showed better compliance and had fewer drop-outs.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Polvani', 'Affiliation': 'Dipartimento Medico Ciba Geigy S.p.A. Origgio, Varese.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zichella', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bocci', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bottiglioni', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cagnazzo', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Campagnoli', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Carenza', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cianci', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Danesino', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'De Cecco', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
3218,31949093,Retinal vessel diameter changes after 6 months of treatment in the Idiopathic Intracranial Hypertension Treatment Trial.,"BACKGROUND/AIMS


Prior studies support an association between increased retinal venule diameter and elevated intracranial pressure (ICP). The purpose of this study was to test the hypothesis that retinal venule diameters decrease in association with long-term therapy for high ICP in subjects with idiopathic intracranial hypertension (IIH).
METHODS


This is a retrospective analysis of multicentre randomised controlled trial data. Standardised procedures were used to measure area of optic nerve head elevation (ONHA) and diameters of 4 arterioles and 4 venules 2.7 mm from the optic disc centre on fundus photos collected at baseline and after 6 months of randomised treatment with placebo+diet or acetazolamide+diet in subjects participating in the IIH Treatment Trial (IIHTT) (n=115). Change in arteriole (Da) and venule (Dv) diameters from baseline to 6 months was studied as a function of IIH, haemodynamic and demographic variables.
RESULTS


Dv decreased following 6 months of therapy (8.1 µm, 5.9%, p<0.0005) but Da did not change. Dv change was associated with ONHA change (p<0.0005, r=0.47) and this association persisted in multiple variable models.
CONCLUSIONS


Retinal venule diameter decreased, and arteriole diameter did not change in association with treatment for elevated ICP with a weight loss intervention and placebo or acetazolamide in IIHTT participants. Further study is needed to determine how retinal vessel measurements can be combined with other clinical observations to inform disease management.",2020,"Dv decreased following 6 months of therapy (8.1 µm, 5.9%, p<0.0005) but Da did not change.",['subjects with idiopathic intracranial hypertension (IIH'],"['placebo+diet\u2009or acetazolamide+diet', 'placebo or acetazolamide']","['Change in arteriole (Da) and venule (Dv) diameters', 'ONHA change', 'Retinal vessel diameter changes']","[{'cui': 'C0033845', 'cui_str': 'Idiopathic Intracranial Hypertension'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003847', 'cui_str': 'Arterioles'}, {'cui': 'C0042520', 'cui_str': 'Venules'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0035330', 'cui_str': 'Retinal Blood Vessels'}]",,0.11505,"Dv decreased following 6 months of therapy (8.1 µm, 5.9%, p<0.0005) but Da did not change.","[{'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Moss', 'Affiliation': 'Byers Eye Institute, Stanford University, Palo Alto, California, USA hemoss@stanford.edu.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Hollar', 'Affiliation': 'David and Ilene Flaum Eye Institute, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Fischer', 'Affiliation': 'David and Ilene Flaum Eye Institute, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Feldon', 'Affiliation': 'David and Ilene Flaum Eye Institute, University of Rochester, Rochester, New York, USA.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2019-314648']
3219,3069250,Antimicrobial prophylaxis for vaginal hysterectomy: comparison of two regimens.,"A randomized trial has been performed to evaluate the efficacy of two antibiotic regimens as a prophylaxis for vaginal hysterectomy. The results, especially in terms of microbiological characteristics of the local population, are then discussed.",1988,A randomized trial has been performed to evaluate the efficacy of two antibiotic regimens as a prophylaxis for vaginal hysterectomy.,['vaginal hysterectomy'],['Antimicrobial prophylaxis'],[],"[{'cui': 'C0020700', 'cui_str': 'Colpohysterectomy'}]","[{'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]",[],,0.0241288,A randomized trial has been performed to evaluate the efficacy of two antibiotic regimens as a prophylaxis for vaginal hysterectomy.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mele', 'Affiliation': '2nd Institute of Obstetrics and Gynecology, University of Bari, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gargano', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Greco', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tartagni', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
3220,31482477,Sexual health and rehabilitation after ovarian suppression treatment (SHARE-OS): a clinical intervention for young breast cancer survivors.,"PURPOSE


Each year, thousands of young breast cancer (BC) patients confront the difficult decision to medically suppress ovarian function and undergo abrupt, premature menopause to reduce risk of cancer recurrence. Unlike natural menopause, young women undergoing ovarian suppression (OS) face severe and disruptive side effects. Profound sexual dysfunction is one of the most prevalent, distressing side effects of OS treatment. Unmanaged sexual dysfunction is also a primary predictor of non-adherence to this potentially life-saving treatment. We developed and tested a brief, psychosexual intervention targeted to manage sexual dysfunction and psychological distress after OS in young BC survivors.
METHODS


Twenty young BC survivors with sexual dysfunction received a single 4-h group intervention that included sexual health rehabilitation, body awareness exercises, and mindfulness-based cognitive therapy (MBCT) skills followed by a single tailored booster telephone call 1-month later. Assessment of female sexual function and psychological distress was completed at baseline and 2 months post-intervention.
RESULTS


Analyses examined changes pre- to post-intervention. Female sexual health improved significantly from baseline to follow-up (n = 19, p < 0.02). Anxiety was also significantly improved at the 2-month (p < 0.000) timepoint, compared with baseline 1. Moderate-to-large effect sizes were observed regarding changes in sexual function and psychological distress.
CONCLUSIONS


Significant improvements in sexual functioning and psychological distress were observed 2 months post-intervention.
IMPLICATIONS FOR CANCER SURVIVORS


These results demonstrate that delivery of a targeted intervention in brief, low-intensity group setting is a promising model for reducing distressing sexual dysfunction in young BC survivors on OS treatment.",2020,"Anxiety was also significantly improved at the 2-month (p < 0.000) timepoint, compared with baseline 1.","['Twenty young BC survivors with sexual dysfunction', 'young breast cancer survivors', 'FOR CANCER SURVIVORS', 'young BC survivors']","['single 4-h group intervention that included sexual health rehabilitation, body awareness exercises, and mindfulness-based cognitive therapy (MBCT) skills followed by a single tailored booster telephone call 1-month later', 'ovarian suppression treatment (SHARE-OS', 'psychosexual intervention']","['female sexual function and psychological distress', 'sexual dysfunction and psychological distress', 'sexual function and psychological distress', 'distressing sexual dysfunction', 'Anxiety', 'sexual functioning and psychological distress', 'Female sexual health']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0563648', 'cui_str': 'Suppression treatment (regime/therapy)'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}]",20.0,0.0214594,"Anxiety was also significantly improved at the 2-month (p < 0.000) timepoint, compared with baseline 1.","[{'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Bober', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA. Sharon_bober@dfci.harvard.edu.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fine', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Recklitis', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00800-x']
3221,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE


Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS


Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS


V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION


Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
3222,31357916,Efficacy evaluation of exercise as an augmentation strategy to brief behavioral activation treatment for depression: a randomized pilot trial.,"Exercise is an efficacious intervention for mental and physical health, but few studies have identified the additive benefits of exercise prescriptions for those undergoing empirically supported psychosocial treatment. Behavioral activation (BA) involves completing activities to improve mood, an ideal format for exercise augmentation. The purpose of this study was to examine the credibility and exploratory effect size estimates of augmenting BA with exercise. Thirty-one sedentary, depressed patients were randomized to receive nine sessions of BA+exercise or BA+stretching over 12 weeks. Monthly assessments of depression, quality of life, distress intolerance (DI), perceived stress, and exercise were conducted. Results demonstrated strong credibility and completion rates of BA+exercise, comparable to other PA interventions. Randomization did not contribute to differential exercise between conditions; all participants engaged in more exercise over time. Similarly, all participants significantly improved on all outcomes over time. Condition differences emerged for DI and perceived stress; the exercise condition evidenced greater improvements over time. Participants who engaged in more exercise also evidenced greater and faster declines in depression. BA may be a useful strategy for improving depression and increasing exercise. Additional explicit exercise prescriptions may not be necessary to improve depression but may be helpful for DI and stress. Clinical Trials Registry (clinicaltrials.gov): NCT02176408, ""Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression"".",2020,Condition differences emerged for DI and perceived stress; the exercise condition evidenced greater improvements over time.,"['Thirty-one sedentary, depressed patients', 'Major Depression', 'depression']","['BA+exercise or BA+stretching', 'Adjunctive Exercise', 'exercise', 'Exercise', 'Behavioral activation (BA', 'Additional explicit exercise prescriptions']","['strong credibility and completion rates of BA+exercise', 'depression, quality of life, distress intolerance (DI), perceived stress, and exercise', 'depression']","[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0034380'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",31.0,0.0529743,Condition differences emerged for DI and perceived stress; the exercise condition evidenced greater improvements over time.,"[{'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Szuhany', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2019.1641145']
3223,31601514,COMPARZ Post Hoc Analysis: Characterizing Pazopanib Responders With Advanced Renal Cell Carcinoma.,"BACKGROUND


The phase III COMPARZ study showed noninferior efficacy of pazopanib versus sunitinib in advanced renal cell carcinoma. In this COMPARZ post hoc analysis we characterized pazopanib responders, patient subgroups with better outcomes, and the effect of dose modification on efficacy and safety.
PATIENTS AND METHODS


Patients were randomized to pazopanib 800 mg/d (n = 557) or sunitinib 50 mg/d, 4 weeks on/2 weeks off (n = 553). Secondary end points included time to complete response (CR)/partial response (PR); the proportion of patients with CR/PR ≥10 months and progression-free survival (PFS) ≥10 months; efficacy in patients with baseline metastasis; and logistic regression analyses of patient characteristics associated with CR/PR ≥10 months. Median PFS, objective response rate (ORR), and safety were evaluated in patients with or without dose reductions or interruptions lasting ≥7 days.
RESULTS


Median time to response was numerically shorter for patients treated with pazopanib versus sunitinib (11.9 vs. 17.4 weeks). Similar percentages of pazopanib and sunitinib patients had CR/PR ≥10 months (14% and 13%, respectively), and PFS ≥10 months (31% and 34%, respectively). For patients without versus with adverse event (AE)-related dose reductions, median PFS, median overall survival, and ORR were 7.3 versus 12.5 months, 21.7 versus 36.8 months, and 22% versus 42% (all P < .0001) for pazopanib, and 5.5 versus 13.8 months, 18.1 versus 38.0 months, and 16% versus 34% (all P < .0001) for sunitinib; results were similar for dose interruptions.
CONCLUSION


Dose modifications when required because of AEs were associated with improved efficacy, suggesting that AEs might be used as a surrogate marker of adequate dosing for individual patients.",2019,"RESULTS


Median time to response was numerically shorter for patients treated with pazopanib versus sunitinib (11.9 vs. 17.4 weeks).","['Patients', 'advanced renal cell carcinoma', 'Responders With Advanced Renal Cell Carcinoma']","['Pazopanib', 'pazopanib', 'COMPARZ Post', 'sunitinib']","['Median time to response', 'efficacy and safety', 'time to complete response (CR)/partial response (PR); the proportion of patients with CR/PR\xa0≥10 months and progression-free survival (PFS)\xa0≥10 months; efficacy', 'median PFS, median overall survival, and ORR', 'Median PFS, objective response rate (ORR), and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.108855,"RESULTS


Median time to response was numerically shorter for patients treated with pazopanib versus sunitinib (11.9 vs. 17.4 weeks).","[{'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Weill Cornell Medicine, Hematology/Oncology, New York, NY. Electronic address: cns9006@cornell.med.edu.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Texas Oncology/Baylor Sammons Cancer Center, Dallas, TX.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kollmannsberger', 'Affiliation': 'Division of Medical Oncology, The University of British Columbia, BCCA Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Georg A', 'Initials': 'GA', 'LastName': 'Bjarnason', 'Affiliation': 'Division of Medical Oncology, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Paul Nathan', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Center, Northwood, United Kingdom.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Medical Oncology, I.R.C.C.S. San Matteo University Hospital Foundation, Pavia, Italy.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'University Hospital Essen, West-German Cancer Center, Internal Medicine (Tumor research) and Clinic for Urology, Essen, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dezzani', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.01.015']
3224,31363811,Is There a Breast Augmentation Outcome Difference Between Subfascial and Subglandular Implant Placement? A Prospective Randomized Double-Blinded Study.,"INTRODUCTION


Subfascial breast augmentation is gaining popularity because of no distortion when the pectoral muscle is contracted and minimizing visualization of the edges of the implant. Although some studies have reported a satisfactory outcome with subfascial technique, it still is controversial the influence of the pectoral fascia and outcome compared to the subglandular technique. Therefore, this prospective randomized study aimed to investigate whether there are clinical/radiological differences between subfascial and subglandular pockets following primary breast augmentation.
METHODS


Twenty patient candidates for primary breast augmentation were recruited. Each patient was selected for subfascial or subglandular pockets in a randomized fashion. Both patient and surgeon were blinded. Clinical and radiological differences were evaluated through five independent surgeons and MRI (capsule, folds, fluids, base and projection). Median follow-up was 12 months.
RESULTS


Breast consistency (p = 0.24), implant pocket (p = 0.52), symmetry (p = 1), contour, and shape (p = 0.09) demonstrated no statistically significant difference after the surgeons' assessments at 3 and 12 months after surgery. MRIs demonstrated a larger implant base in the subfascial group (p = 0.024). No differences were observed in capsule thickness (p = 0.42), folds (p = 0.51), fluids (p = 0.28), or projection (0.20).
CONCLUSION


The choice between subfascial and subglandular planes shows no clinical differences and can be selected according to individual professional experience, not evidencing any advantages of one over the other.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2019,"No differences were observed in capsule thickness (p = 0.42), folds (p = 0.51), fluids (p = 0.28), or projection (0.20).
",['Twenty patient candidates for primary breast augmentation were recruited'],[],"['MRIs', 'capsule thickness', 'implant pocket']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty (procedure)'}]",[],"[{'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]",,0.150105,"No differences were observed in capsule thickness (p = 0.42), folds (p = 0.51), fluids (p = 0.28), or projection (0.20).
","[{'ForeName': 'Ivan Maluf', 'Initials': 'IM', 'LastName': 'Junior', 'Affiliation': 'Aesthetic and Reconstructive Plastic Surgery Service at Hospital de Clínicas, Universidade Federal Do Paraná (UFPR), Curitiba, Paraná State, Brazil. ivanmalufjr@yahoo.com.br.'}, {'ForeName': 'Ruth Maria', 'Initials': 'RM', 'LastName': 'Graf', 'Affiliation': 'Plastic Surgery Service at Hospital de Clínicas, UFPR, Sao Paulo, Brazil.'}, {'ForeName': 'Adriana Sayuri Kurogi', 'Initials': 'ASK', 'LastName': 'Ascenço', 'Affiliation': 'Aesthetic and Reconstructive Plastic Surgery Service at Hospital de Clínicas, Universidade Federal Do Paraná (UFPR), Curitiba, Paraná State, Brazil.'}, {'ForeName': 'Willian', 'Initials': 'W', 'LastName': 'Itikawa', 'Affiliation': 'Aesthetic and Reconstructive Plastic Surgery Service at Hospital de Clínicas, Universidade Federal Do Paraná (UFPR), Curitiba, Paraná State, Brazil.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Balbinot', 'Affiliation': 'Aesthetic and Reconstructive Plastic Surgery Service at Hospital de Clínicas, Universidade Federal Do Paraná (UFPR), Curitiba, Paraná State, Brazil.'}, {'ForeName': 'Alexandre Mendonça', 'Initials': 'AM', 'LastName': 'Munhoz', 'Affiliation': 'Hospital Sírio-Libanês, São Paulo, SP, Brazil.'}, {'ForeName': 'Marlon Câmara', 'Initials': 'MC', 'LastName': 'Lopes', 'Affiliation': 'Aesthetic and Reconstructive Plastic Surgery Service at Hospital de Clínicas, Universidade Federal Do Paraná (UFPR), Curitiba, Paraná State, Brazil.'}, {'ForeName': 'Isis Juliane Guarezi', 'Initials': 'IJG', 'LastName': 'Nasser', 'Affiliation': 'Aesthetic and Reconstructive Plastic Surgery Service at Hospital de Clínicas, Universidade Federal Do Paraná (UFPR), Curitiba, Paraná State, Brazil.'}, {'ForeName': 'Linei Augusta Brolini Dellê', 'Initials': 'LABD', 'LastName': 'Urban', 'Affiliation': 'Diagnóstico Avançado Por Imagem (Center of Advanced Imaging Diagnosis), DAPI, Curitiba, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'da Silva Freitas', 'Affiliation': 'Plastic Surgery Service at Hospital de Clínicas, UFPR, Sao Paulo, Brazil.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01465-8']
3225,30605517,"A Pilot Randomized Controlled Trial Comparing Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain.","OBJECTIVE


This pilot trial compared the feasibility, tolerability, acceptability, and effects of group-delivered mindfulness meditation (MM), cognitive therapy (CT), and mindfulness-based cognitive therapy (MBCT) for chronic low back pain (CLBP).
SETTING


University of Queensland Psychology Clinic.
SUBJECTS


Participants were N = 69 (intent-to-treat [ITT] sample) adults with CLBP.
DESIGN


A pilot, assessor-blinded randomized controlled trial.
METHODS


Participants were randomized to treatments. The primary outcome was pain interference; secondary outcomes were pain intensity, physical function, depression, and opioid medication use. The primary study end point was post-treatment; maintenance of gains was evaluated at three- and six-month follow-up.
RESULTS


Ratings of acceptability, and ratios of dropout and attendance showed that MBCT was acceptable, feasible, and well tolerated, with similar results found across conditions. For the ITT sample, large improvements in post-treatment scores for pain interference, pain intensity, physical function, and depression were found (P < 0.001), with no significant between-group differences. Analysis of the follow-up data (N = 43), however, revealed that MBCT participants improved significantly more than MM participants on pain interference, physical function, and depression. The CT group improved more than MM in physical function. The MBCT and CT groups did not differ significantly on any measures.
CONCLUSIONS


This is the first study to examine MBCT for CLBP management. The findings show that MBCT is a feasible, tolerable, acceptable, and potentially efficacious treatment option for CLBP. Further, MBCT, and possibly CT, could have sustained benefits that exceed MM on some important CLBP outcomes. A future definitive randomized controlled trial is needed to evaluate these treatments and their differences.",2019,"For the ITT sample, large improvements in post-treatment scores for pain interference, pain intensity, physical function, and depression were found (P < 0.001), with no significant between-group differences.","['Setting\n\n\nUniversity of Queensland Psychology Clinic', 'chronic low back pain (CLBP', 'Chronic Low Back Pain', 'Subjects\n\n\nParticipants were N\u2009=\u200969 (intent-to-treat [ITT] sample) adults with CLBP']","['CT', 'group-delivered mindfulness meditation (MM), cognitive therapy (CT), and mindfulness-based cognitive therapy (MBCT', 'Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy', 'MBCT']","['feasibility, tolerability, acceptability', 'post-treatment; maintenance of gains', 'Ratings of acceptability, and ratios of dropout and attendance', 'pain interference, pain intensity, physical function, and depression', 'pain interference; secondary outcomes were pain intensity, physical function, depression, and opioid medication use', 'pain interference, physical function, and depression']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C3811912', 'cui_str': 'Psychology clinic'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.0890317,"For the ITT sample, large improvements in post-treatment scores for pain interference, pain intensity, physical function, and depression were found (P < 0.001), with no significant between-group differences.","[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Day', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'L Charles', 'Initials': 'LC', 'LastName': 'Ward', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Beverly E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Burns', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Barnier', 'Affiliation': 'Department of Cognitive Science, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Mattingley', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny273']
3226,32047963,The efficacy of immersive virtual reality surgical simulator training for pedicle screw placement: a randomized double-blind controlled trial.,"OBJECTIVE


To verify whether the pedicle screw placement (PSP) skills of young surgeons receiving immersive virtual reality surgical simulator (IVRSS) training could be improved effectively and whether the IVRSS-PSP training mode could produce a real clinical value in clinical surgery.
METHODS


Twenty-four young surgeons were equally randomized to a VR group and a NON-VR group. Participants in VR group received IVRSS-PSP training, and those in NON-VR group used the conventional model of observing a spinal model first and then watching a teaching video of spinal surgery for 40 minutes x five. The nailing outcome of the participants before and after training was evaluated by statistical analysis in both groups.
RESULTS


Post-training data analysis showed that the success rate and accuracy rate of screw placement in VR group and NON-VR group were 82.9% and 69.6% vs. 74.2% and 55.4%, respectively, showing statistically significant differences between the two groups by chi-square test (P < 0.05).
CONCLUSION


The present study demonstrated that IVRSS-PSP was helpful to improve the success rate of PSP for young surgeons, and may provide valuable reference for PSP training of young surgeons. In addition, our study also showed a promising potential of the VR technology in surgical simulation training.",2020,"RESULTS


Post-training data analysis showed that the success rate and accuracy rate of screw placement in VR group and NON-VR group were 82.9% and 69.6% vs. 74.2% and 55.4%, respectively, showing statistically significant differences between the two groups by chi-square test (P < 0.05).
","['Twenty-four young surgeons', 'pedicle screw placement', 'young surgeons receiving']","['pedicle screw placement (PSP', 'IVRSS-PSP', 'IVRSS-PSP training', 'immersive virtual reality surgical simulator (IVRSS) training', 'VR group and a NON-VR group', 'immersive virtual reality surgical simulator training']","['nailing outcome', 'success rate of PSP', 'success rate and accuracy rate of screw placement']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",24.0,0.0340094,"RESULTS


Post-training data analysis showed that the success rate and accuracy rate of screw placement in VR group and NON-VR group were 82.9% and 69.6% vs. 74.2% and 55.4%, respectively, showing statistically significant differences between the two groups by chi-square test (P < 0.05).
","[{'ForeName': 'Baoquan', 'Initials': 'B', 'LastName': 'Xin', 'Affiliation': 'Shandong First Medical University & Shandong Academy of Medical Sciences, Taian, Shandong province, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wan', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Lv', 'Affiliation': 'Anhui university of Chinese Medicine, 103 Meishan road, Shushan district, Anhui province, China.'}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': 'Medical Imaging Department, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China. czyyzww@163.com.'}, {'ForeName': 'Jianru', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China. jianruxiao83@163.com.'}, {'ForeName': 'Tielong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Orthopaedic Oncology Center, Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, 415 Fengyang Road, Shanghai, 200003, China. czyygzl@163.com.'}]",International orthopaedics,['10.1007/s00264-020-04488-y']
3227,32057546,"Effects of interactive robot-enhanced hand rehabilitation in treatment of paediatric hand-burns: A randomized, controlled trial with 3-months follow-up.","PURPOSE


To evaluate the effectiveness of the robotic-assisted exercise with virtual gaming on total active range of motion (ROM) of the digits, hand grip strength (HGS), and hand function in children with hand burns.
METHODS


Thirty-three children with burn caused by thermal injury (flame or scald) with the involvement of the wrist and hand, total body surface area (TBSA) <30%, and age between 6-12 years, were included in this study. The patients were randomly allocated to one of the two groups; control group (n = 16; received 60-min of the traditional hand rehabilitation program, three times per week for two successive months) and experimental group (n = 17; engaged in an additional 20 min of interactive robot-enhanced hand rehabilitation besides the traditional rehabilitation). Outcomes measured were the total active ROM of the digits, HGS, and hand function at three occasions during the study: at the baseline, post-treatment, and 3 months follow-up.
RESULTS


In the experimental group, results regarding total active (ROM) of the digits, HGS, and hand function were statistically significant in comparison to the control group either after treatment (P < .05, P = .04, and P = .005) respectively or at the follow-up (P < .05, P = .023, and P = .012) respectively favoring the experimental group.
CONCLUSION


The robot-enhanced exercise with virtual gaming can increase total active ROM of the fingers' digits, improve HGS, and hand function in children with hand burns.",2020,"(P < .05, P = .023, and P = .012) respectively favoring the experimental group.
","['paediatric hand-burns', 'children with hand burns', 'Thirty-three children with burn caused by thermal injury (flame or scald) with the involvement of the wrist and hand, total body surface area (TBSA', '30%, and age between 6-12 years']","['60-min of the traditional hand rehabilitation program, three times per week for two successive months) and experimental group (n = 17; engaged in an additional 20 min of interactive robot-enhanced hand rehabilitation besides the traditional rehabilitation', 'robotic-assisted exercise with virtual gaming', 'robot-enhanced exercise with virtual gaming', 'interactive robot-enhanced hand rehabilitation']","['total active range of motion (ROM) of the digits, hand grip strength (HGS), and hand function', 'total active (ROM) of the digits, HGS, and hand function', 'total active ROM of the digits, HGS, and hand function', ""total active ROM of the fingers' digits, improve HGS, and hand function""]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0332685', 'cui_str': 'Thermal injury'}, {'cui': 'C0332691', 'cui_str': 'Scalding injury (morphologic abnormality)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more (body structure)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",33.0,0.0216215,"(P < .05, P = .023, and P = .012) respectively favoring the experimental group.
","[{'ForeName': 'Ahmed F', 'Initials': 'AF', 'LastName': 'Samhan', 'Affiliation': 'Department of Physical Therapy, New Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt; Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Saudi Arabia. Electronic address: ahmedsamhan44@yahoo.com.'}, {'ForeName': 'Nermeen M', 'Initials': 'NM', 'LastName': 'Abdelhalim', 'Affiliation': 'Department of Physical Therapy, New Kasr El-Aini Teaching Hospital, Faculty of Medicine, Cairo University, Cairo, Egypt; Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Saudi Arabia.'}, {'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt; Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Saudi Arabia.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.01.015']
3228,32041812,Impact of an education and multilevel social comparison-based intervention bundle on use of routine blood tests in hospitalised patients at an academic tertiary care hospital: a controlled pre-intervention post-intervention study.,"BACKGROUND


Repetitive inpatient laboratory testing contributes to waste in healthcare. We evaluated an intervention bundle combining education and multilevel social comparison feedback to safely reduce repetitive use of inpatient routine laboratory tests.
METHODS


This non-randomised controlled pre-intervention post-intervention study was conducted in four adult hospitals from October 2016 to March 2018. In the medical teaching unit (MTU) of the intervention site, learners received education and aggregate social comparison feedback and attending internists received individual comparison feedback on routine laboratory test utilisation. MTUs of the remaining three sites served as control units. Number and cost of routine laboratory tests ordered per patient-day before and after the intervention was compared with the control units, adjusting for patient factors. Safety endpoints included number of critically abnormal laboratory test results, number of stat laboratory test orders, patient length of stay, transfer rate to the ICU, and 30-day readmission and mortality.
RESULTS


A total of 14 000 patients were included. Pre-intervention and post-intervention groups were similar in age, sex, Charlson Comorbidity Index and length of stay. From the pre-intervention period to the post-intervention period, significantly fewer routine laboratory tests were ordered at the intervention MTU (incidence rate ratio=0.89; 95% CI 0.79 to 1.00; p=0.048) with associated costs savings of $C68 877 (p=0.020) as compared with the control sites. The variability in the ordering pattern of internists at the intervention site also decreased post-intervention. No worsening was noted in the safety endpoints between the pre-intervention and post-intervention period at the intervention unit compared with the controls.
CONCLUSIONS


Combination of education and multilevel social comparison feedback significantly and  safely  led to cost savings through reduced use of routine laboratory tests in hospitalised patients.",2020,"No worsening was noted in the safety endpoints between the pre-intervention and post-intervention period at the intervention unit compared with the controls.
","['A total of 14\u2009000 patients were included', 'hospitalised patients at an academic tertiary care hospital', 'hospitalised patients', 'four adult hospitals from October 2016 to March 2018']","['education and aggregate social comparison feedback and attending internists received individual comparison feedback', 'education and multilevel social comparison-based intervention bundle']","['costs savings', 'Number and cost of routine laboratory tests', 'safety endpoints', 'number of critically abnormal laboratory test results, number of stat laboratory test orders, patient length of stay, transfer rate to the ICU, and 30-day readmission and mortality', 'routine laboratory tests']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0278602', 'cui_str': 'Internal medicine specialist (occupation)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test result'}, {'cui': 'C0205548', 'cui_str': 'Stat (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",14000.0,0.0222036,"No worsening was noted in the safety endpoints between the pre-intervention and post-intervention period at the intervention unit compared with the controls.
","[{'ForeName': 'Anshula', 'Initials': 'A', 'LastName': 'Ambasta', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada aambasta@ucalgary.ca.'}, {'ForeName': 'Irene Wai Yan', 'Initials': 'IWY', 'LastName': 'Ma', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Woo', 'Affiliation': 'Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Lonergan', 'Affiliation': 'Analysis, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mackay', 'Affiliation': 'Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Williamson', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}]",BMJ quality & safety,['10.1136/bmjqs-2019-010118']
3229,31834588,"Training Executive, Attention, and Motor Skills (TEAMS): a Preliminary Randomized Clinical Trial of Preschool Youth with ADHD.","This preliminary randomized controlled trial compared Training Executive, Attention and Motor Skills (TEAMS), a played-based intervention for preschool children with attention-deficit/hyperactivity disorder (ADHD), to an active comparison intervention consisting of parent education and support (ClinicalTrials.gov Identifier: NCT01462032). The primary aims were to gauge preliminary efficacy and assist in further development of TEAMS. Four- and 5-year-old children with ADHD were randomly assigned to receive TEAMS (N = 26) or the comparison intervention (N = 26) with blinded assessments by parents, teachers and clinicians ascertained pretreatment, post-treatment, and 1- and 3-months post-treatment. Changes in ADHD severity, impairment, parenting factors, and neuropsychological functioning over time as a function of treatment condition were assessed using the PROC MIXED procedure in SAS. Across most measures, significant main effects for Time emerged; both treatments were associated with reduced ADHD symptoms that persisted for three months post-treatment. There were no significant Treatment effects or Time x Treatment interactions on symptom and impairment measures, suggesting that the magnitude of improvement did not differ between the two interventions. However, significant correlations emerged between the magnitude of behavioral change, as assessed by parents and clinicians, and the amount of time families engaged in TEAMS-related activities during treatment. Across a wide array of parenting and neuropsychological measures, there were few significant group differences over time. TEAMS and other psychosocial interventions appear to provide similar levels of benefit. Play-based interventions like TEAMS represent a potentially viable alternative/addition to current ADHD treatments, particularly for young children, but more research and further development of techniques are necessary.",2020,"Across most measures, significant main effects for Time emerged; both treatments were associated with reduced ADHD symptoms that persisted for three months post-treatment.","['preschool children with attention-deficit/hyperactivity disorder (ADHD', 'Four- and 5-year-old children with ADHD', 'Preschool Youth with ADHD', 'young children']","['TEAMS', 'Training Executive, Attention, and Motor Skills (TEAMS', 'Training Executive, Attention and Motor Skills (TEAMS), a played-based intervention', 'comparison intervention (N\u2009=\u200926) with blinded assessments by parents, teachers and clinicians ascertained pretreatment, post-treatment, and 1- and 3-months post-treatment']","['ADHD symptoms', 'ADHD severity, impairment, parenting factors, and neuropsychological functioning over time as a function of treatment condition']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",26.0,0.122594,"Across most measures, significant main effects for Time emerged; both treatments were associated with reduced ADHD symptoms that persisted for three months post-treatment.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Halperin', 'Affiliation': 'Psychology Department, Queens College and the Graduate Center, City University of New York, 65-30 Kissena Boulevard, Flushing, New York, 11367, USA. jeffrey.halperin@qc.cuny.edu.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Marks', 'Affiliation': 'NYU Child Study Center, New York, NY, USA.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Chacko', 'Affiliation': 'New York University - Steinhardt School of Culture, Education, and Human Development, New York, NY, USA.'}, {'ForeName': 'Anne-Claude', 'Initials': 'AC', 'LastName': 'Bedard', 'Affiliation': 'Ontario Institute for Studies in Education, the University of Toronto, Toronto, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': ""O'Neill"", 'Affiliation': 'The City College and the Graduate Center, City University of New York, New York, NY, USA.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Curchack-Lichtin', 'Affiliation': 'The Hallowell Center, New York, NY, USA.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Bourchtein', 'Affiliation': 'Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Olga G', 'Initials': 'OG', 'LastName': 'Berwid', 'Affiliation': 'York College, City University of New York, New York, NY, USA.'}]",Journal of abnormal child psychology,['10.1007/s10802-019-00610-w']
3230,32028315,Intramedullary Nailing Versus External Fixation in the Treatment of Open Tibial Fractures in Tanzania: Results of a Randomized Clinical Trial.,"BACKGROUND


Open tibial fractures are common injuries in low and middle-income countries, but there is no consensus regarding treatment with intramedullary nailing versus external fixation. The purpose of the present study was to compare the outcomes of initial treatment with intramedullary nailing or external fixation in adults with open tibial fractures.
METHODS


We conducted a randomized clinical trial (RCT) at a tertiary orthopaedic center in Tanzania. Adults with acute diaphyseal open tibial fractures were randomly assigned to statically locked, hand-reamed intramedullary nailing or uniplanar external fixation. The primary outcome was death or reoperation for the treatment of deep infection, nonunion, or malalignment. Secondary outcomes included quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) questionnaire, radiographic alignment, and healing as measured with the modified Radiographic Union Scale for Tibial fractures (mRUST).
RESULTS


Of the 240 patients who were enrolled, 221 (92.1%) (including 111 managed with intramedullary nailing and 110 managed with external fixation) completed 1-year follow-up. There were 44 primary outcome events (with rates of 18.0% and 21.9% in the intramedullary nailing and external fixation groups, respectively) (relative risk [RR] = 0.83 [95% confidence interval (CI), 0.49 to 1.41]; p = 0.505). There was no significant difference between the groups in terms of the rate of deep infection. Intramedullary nailing was associated with a lower risk of coronal malalignment (RR = 0.11 [95% CI, 0.01 to 0.85]; p = 0.01) and sagittal malalignment (RR = 0.17 [95% CI, 0.02 to 1.35]; p = 0.065) at 1 year. The EQ-5D index favored intramedullary nailing at 6 weeks (mean difference [MD] = 0.07 [95% CI = 0.03 to 0.11]; p < 0.001), but this difference dissipated by 1 year. Radiographic healing (mRUST) favored intramedullary nailing at 6 weeks (MD = 1.2 [95% CI = 0.4 to 2.0]; p = 0.005), 12 weeks (MD = 1.0 [95% CI = 0.3 to 1.7]; p = 0.005), and 1 year (MD = 0.8 [95% CI = 0.2 to 1.5]; p = 0.013).
CONCLUSIONS


To our knowledge, the present study is the first RCT assessing intramedullary nailing versus external fixation for the treatment of open tibial fractures in sub-Saharan Africa. Differences in primary events were not detected, and only coronal alignment significantly favored the use of intramedullary nailing.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Differences in primary events were not detected, and only coronal alignment significantly favored the use of intramedullary nailing.
","['tertiary orthopaedic center in Tanzania', 'open tibial fractures in sub-Saharan Africa', 'Open Tibial Fractures in Tanzania', 'Adults with acute diaphyseal open tibial fractures', '240 patients who were enrolled, 221 (92.1%) (including 111 managed with intramedullary nailing and 110 managed with external fixation) completed 1-year follow-up', 'adults with open tibial fractures']","['Intramedullary nailing', 'Intramedullary Nailing Versus External Fixation', 'intramedullary nailing and external fixation', 'intramedullary nailing', 'intramedullary nailing or external fixation', 'intramedullary nailing versus external fixation', 'statically locked, hand-reamed intramedullary nailing or uniplanar external fixation', 'RCT assessing intramedullary nailing versus external fixation']","['Radiographic healing (mRUST', 'sagittal malalignment', 'death or reoperation for the treatment of deep infection, nonunion, or malalignment', 'lower risk of coronal malalignment', 'EQ-5D index favored intramedullary nailing', 'rate of deep infection', 'quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) questionnaire, radiographic alignment, and healing as measured with the modified Radiographic Union Scale for Tibial fractures (mRUST']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0443339', 'cui_str': 'Uniplanar (qualifier value)'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}]",240.0,0.135656,"Differences in primary events were not detected, and only coronal alignment significantly favored the use of intramedullary nailing.
","[{'ForeName': 'Billy T', 'Initials': 'BT', 'LastName': 'Haonga', 'Affiliation': 'Muhimbili Orthopaedic Institute, Muhimbili National Hospital, Dar es Salaam, Tanzania.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Albright', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}, {'ForeName': 'Sravya T', 'Initials': 'ST', 'LastName': 'Challa', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}, {'ForeName': 'Syed H', 'Initials': 'SH', 'LastName': 'Ali', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}, {'ForeName': 'Ann A', 'Initials': 'AA', 'LastName': 'Lazar', 'Affiliation': 'Division of Oral Epidemiology, School of Dentistry, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Edmund N', 'Initials': 'EN', 'LastName': 'Eliezer', 'Affiliation': 'Muhimbili Orthopaedic Institute, Muhimbili National Hospital, Dar es Salaam, Tanzania.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Shearer', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}, {'ForeName': 'Saam', 'Initials': 'S', 'LastName': 'Morshed', 'Affiliation': 'Institute for Global Orthopaedics and Traumatology, Department of Orthopaedic Surgery, University of California San Francisco School of Medicine, San Francisco, California.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00563']
3231,32024944,CYP2C9 and VKORC1 genotyping for the quality of long-standing warfarin treatment in Russian patients.,"A total of 263 warfarin naive patients with indications to long-term anticoagulation were included in prospective multicenter study and randomized into Pharmacogenetics and Standard dosing groups. The loading warfarin dose in Pharmacogenetics group was calculated by Gage algorithm and corrected starting on day 5 of treatment according to INR. In Standard dosing group warfarin initial dose was 5 mg and starting on day 3 of treatment it was titrated according to INR. Pharmacogenetics dosing in comparison with prescription of starting dose of 5 mg decreased major bleedings (0 vs. 6, p = 0.031), time to target INR (11 [9-14] vs. 17 [15-24] days, p = 0.046), and frequency of INR fluctuations ≥4.0 (11% vs. 30.9%, p = 0.002). The advantages of the pharmacogenetics dosing were mainly achieved due to the patients with increased warfarin sensitivity.",2020,"Pharmacogenetics dosing in comparison with prescription of starting dose of 5 mg decreased major bleedings (0 vs. 6, p = 0.031), time to target INR (11 [9-14] vs. 17 [15-24] days, p = 0.046), and frequency of INR fluctuations ≥4.0 (11% vs. 30.9%, p = 0.002).","['263 warfarin naive patients with indications to long-term anticoagulation', 'Russian patients']",[],"['frequency of INR fluctuations', 'time to target INR', 'major bleedings']","[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337816', 'cui_str': 'Russians (ethnic group)'}]",[],"[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1504327', 'cui_str': 'International normalised ratio fluctuation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",263.0,0.0222979,"Pharmacogenetics dosing in comparison with prescription of starting dose of 5 mg decreased major bleedings (0 vs. 6, p = 0.031), time to target INR (11 [9-14] vs. 17 [15-24] days, p = 0.046), and frequency of INR fluctuations ≥4.0 (11% vs. 30.9%, p = 0.002).","[{'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Panchenko', 'Affiliation': 'National Medical Research Center of Cardiology of Ministry of Health of the Russian Federation, Moscow, Russian Federation. lizapanchenko@mail.ru.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Kropacheva', 'Affiliation': 'National Medical Research Center of Cardiology of Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Anatoly', 'Initials': 'A', 'LastName': 'Dobrovolsky', 'Affiliation': 'National Medical Research Center of Cardiology of Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Titaeva', 'Affiliation': 'National Medical Research Center of Cardiology of Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Zemlyanskaya', 'Affiliation': 'National Medical Research Center of Cardiology of Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Trofimov', 'Affiliation': 'DNA-Technology JSC, Moscow, Russian Federation.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Galkina', 'Affiliation': 'DNA-Technology JSC, Moscow, Russian Federation.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Lifshits', 'Affiliation': 'Institution of Chemical Biology and Fundamental Medicine, Novosibirsk, Russian Federation.'}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Vereina', 'Affiliation': 'State Medical Academy, Chelyabinsk, Russian Federation.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Sinitsin', 'Affiliation': 'State Medical Academy, Chelyabinsk, Russian Federation.'}, {'ForeName': 'Nadezda', 'Initials': 'N', 'LastName': 'Vorobyeva', 'Affiliation': 'Northern Branch of State Hematological Center, Arhangelsk, Russian Federation.'}, {'ForeName': 'Lyudmila', 'Initials': 'L', 'LastName': 'Grehova', 'Affiliation': 'Cardiolodgical Dispensary of Kirov Regional Clinical Hospital, Vyatka, Russian Federation.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Zateyshchikov', 'Affiliation': 'City Hospital N 51, Moscow, Russian Federation.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Zotova', 'Affiliation': 'City Hospital N 51, Moscow, Russian Federation.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Vavilova', 'Affiliation': 'Mechnikov State Medical Academy, Sankt-Peterburg, Russian Federation.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sirotkina', 'Affiliation': 'Mechnikov State Medical Academy, Sankt-Peterburg, Russian Federation.'}, {'ForeName': 'Alevtina', 'Initials': 'A', 'LastName': 'Grontkovskaya', 'Affiliation': 'State Medical Academy, Nizhniy Novgorod, Russian Federation.'}]",The pharmacogenomics journal,['10.1038/s41397-020-0157-2']
3232,31955491,Efficacy of exenatide and insulin glargine on nonalcoholic fatty liver disease in patients with type 2 diabetes.,"BACKGROUND


The aim of this study was to investigate the efficacy of exenatide and insulin glargine in patients with newly diagnosed type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD).
METHODS


We performed a 24-week randomized controlled multicentre clinical trial. Seventy-six patients were randomly assigned 1:1 to receive exenatide or insulin glargine treatment. The endpoints included changes in liver fat content (LFC), visceral adipose tissue (VAT), and subcutaneous adipose tissue (SAT) measured by magnetic resonance spectroscopy, blood glucose, liver enzymes, lipid profile, body weight, and Fibrosis-4 index (FIB-4).
RESULTS


LFC, VAT, SAT, and FIB-4 were significantly reduced after exenatide treatment (ΔLFC, -17.55 ± 12.93%; ΔVAT, -43.57 ± 68.20 cm 2  ; ΔSAT, -28.44 ± 51.48 cm 2  ; ΔFIB-4, -0.10 ± 0.26; all P < .05). In comparison, only LFC (ΔLFC, -10.49 ± 11.38%; P < .05), and not VAT, SAT, or FIB-4 index (all P > .05), was reduced after insulin glargine treatment. Moreover, exenatide treatment resulted in greater reductions in alanine transaminase (ALT), aspartate transaminase (AST), and gamma glutamyl transpeptidase (GGT) than insulin glargine (P < 0.05). The body weight, waist circumference, postprandial plasma glucose, and low-density lipoprotein cholesterol (LDL-C) in the exenatide group also presented greater reductions than the insulin glargine group (P < .05). The proportion of adverse events were comparable between the two groups.
CONCLUSION


Both exenatide and insulin glargine reduced LFC in patients with drug-naive T2DM and NAFLD; however, exenatide showed greater reductions in body weight, visceral fat area, liver enzymes, FIB-4, postprandial plasma glucose, and LDL-C.",2020,"Both exenatide and insulin glargine reduced LFC in patients with drug-naive T2DM and NAFLD; however, exenatide showed greater reductions in body weight, visceral fat area, liver enzymes, FIB-4, postprandial plasma glucose, and LDL-C.","['Seventy-six patients', 'patients with newly diagnosed type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD', 'Patients with Type 2 Diabetes Mellitus', 'patients with drug-naive T2DM and NAFLD']","['exenatide or insulin glargine treatment', 'Exenatide and Insulin Glargine', 'exenatide and insulin glargine', 'insulin glargine', 'exenatide']","['not VAT, SAT, or FIB-4 index', 'body weight, visceral fat area, liver enzymes, FIB-4, postprandial plasma glucose, and LDL-C', 'proportion of adverse events', 'body weight, waist circumference, postprandial plasma glucose, and low-density lipoprotein cholesterol (LDL-C', 'changes in liver fat content (LFC), visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) measured by magnetic resonance spectroscopy, blood glucose, liver enzymes, lipid profile, body weight, and FIB-4 index (FIB-4', 'Nonalcoholic Fatty Liver Disease', 'LFC, VAT, SAT, and FIB-4', 'alanine transaminase (ALT), aspartate transaminase (AST), and gamma glutamyl transpeptidase (GGT']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0001899', 'cui_str': 'Alanine Aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}]",76.0,0.036181,"Both exenatide and insulin glargine reduced LFC in patients with drug-naive T2DM and NAFLD; however, exenatide showed greater reductions in body weight, visceral fat area, liver enzymes, FIB-4, postprandial plasma glucose, and LDL-C.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'MingFeng', 'Initials': 'M', 'LastName': 'Xia', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minzhi', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': 'Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Naiqin', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Shengxiang', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiuzhong', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Department of Radiology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Weiyun', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Baishen', 'Initials': 'B', 'LastName': 'Pan', 'Affiliation': 'Department of Laboratory Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Bian', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai, China.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3292']
3233,30260486,The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-Based Randomized Trial: The EFFORT Trial.,"Current randomized trials and observational studies evaluating higher versus lower protein doses in critically ill patients yield inconclusive results. Because of few studies and methodologic limitations, clinical guidelines suggest a wide range of protein intake based on weak evidence. Clinical equipoise about protein dosing exists. The purpose of the current manuscript is to provide the rationale and protocol for a randomized controlled trial (RCT) of 4000 critically ill patients randomly allocated to receive a higher or lower protein dose. We propose a global, volunteer-driven, registry-based RCT involving >100 intensive care units (ICUs). We will enroll mechanically ventilated patients with high nutrition risk, identified by low (≤25) or high (≥35) body mass index, moderate to severe malnutrition, frailty, sarcopenia, or when >96-hour duration of mechanical ventilation is expected. Exclusion criteria include patients who are >96 hours since initiation of mechanical ventilation, moribund, or pregnant, and where the clinician lacks clinical equipoise regarding protein dose. The intervention consists of higher (≥2.2 g/kg/d) or lower (≤1.2 g/kg/d) protein dose, achieved by enteral nutrition, parenteral nutrition, or both. The primary outcome will be 60-day mortality. Key secondary outcomes include time-to-discharge alive from hospital, ICU and hospital survival, and length of stay. As this is research based on existing medical practice, we will apply for a waiver of informed consent, where possible. The large sample size is a reflection of the small signal we expect to see in this large, pragmatic trial.",2019,"The intervention consists of higher (≥2.2 g/kg/d) or lower (≤1.2 g/kg/d) protein dose, achieved by enteral nutrition, parenteral nutrition, or both.","['4000 critically ill patients randomly allocated to receive a higher or lower protein dose', 'enroll mechanically ventilated patients with high nutrition risk, identified by low (≤25) or high (≥35) body mass index, moderate to severe malnutrition, frailty, sarcopenia, or when >96-hour duration of mechanical ventilation is expected', 'Exclusion criteria include patients who are >96 hours since initiation of mechanical ventilation, moribund, or pregnant, and where the clinician lacks clinical equipoise regarding protein dose', 'critically ill patients', 'Critically Ill Patients', 'volunteer-driven, registry-based RCT involving >100 intensive care units (ICUs']",['Higher Protein'],"['time-to-discharge alive from hospital, ICU and hospital survival, and length of stay', '60-day mortality']","[{'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0424547', 'cui_str': 'Moribund (finding)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0702057', 'cui_str': 'Equipoise'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",4000.0,0.179966,"The intervention consists of higher (≥2.2 g/kg/d) or lower (≤1.2 g/kg/d) protein dose, achieved by enteral nutrition, parenteral nutrition, or both.","[{'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Department of Critical Care Medicine and Department of Public Health Sciences, Queen's University, and the Clinical Evaluation Research Unit, Kingston General Hospital, Kingston, Ontario, Canada.""}, {'ForeName': 'Jayshil', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Bear', 'Affiliation': ""Department of Critical Care, Department of Nutrition and Dietetics, Guy's and St. Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sacks', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Auburn, Alabama, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Nixdorf', 'Affiliation': 'Trillium Health Partners, Credit Valley Hospital, Mississauga, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dolan', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Aloupis', 'Affiliation': 'University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Licastro', 'Affiliation': 'Trillium Health Partners, Mississauga Hospital, Mississauga, Canada.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Jovanovic', 'Affiliation': 'Trillium Health Partners, Mississauga Hospital, Mississauga, Canada.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Compher', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1449']
3234,32029903,An analysis of the effect of mu-opioid receptor gene (OPRM1) promoter region DNA methylation on the response of naltrexone treatment of alcohol dependence.,"This study explored the effect of OPRM1 promoter region DNA methylation on the outcome of treatment with the opioid antagonist naltrexone (NTX) for alcohol dependence (AD). Ninety-three patients with DSM-IV AD [41 African Americans (AAs) and 52 European Americans (EAs)] received double-blind treatment with NTX or placebo for at least three months. Relapse to heavy drinking was assessed during the first 13 weeks of the trial. Peripheral blood methylation levels of 33 CpG units in the OPRM1 promoter region were quantified using Sequenom EpiTYPER technology. Bayesian logistic regression was used to analyze the effects of NTX treatment, CpG methylation, CpG methylation × NTX treatment, and age on AD relapse. The Random Forest machine learning algorithm was applied to select AD relapse predictors. No significant effect of individual OPRM1 promoter CpG units on AD relapse was observed in either AAs or EAs. Age was significantly associated with AD relapse in EAs, among whom older subjects had a lower relapse rate. Random forest analyses revealed that the prediction rate for AD relapse reached 66.0% with five top variables (age and four CpG units; ranked by their importance to AD relapse) in the prediction model. These findings suggest that methylation levels of individual OPRM1 promoter CpG units do not contribute significantly to inter-individual variation in NTX response. However, the age of subjects in combination with a cluster of specific OPRM1 promoter CpG units may affect NTX treatment outcome. Additional studies of OPRM1 DNA methylation changes during and after NTX treatment of AD are needed.",2020,No significant effect of individual OPRM1 promoter CpG units on AD relapse was observed in either AAs or EAs.,['Ninety-three patients with DSM-IV AD [41 African Americans (AAs) and 52 European Americans (EAs'],"['opioid antagonist naltrexone (NTX', 'NTX or placebo', 'OPRM1 promoter region DNA methylation']","['Peripheral blood methylation levels', 'AD relapse', 'relapse rate', 'prediction rate for AD relapse', 'Relapse to heavy drinking']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}]","[{'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033413', 'cui_str': 'Promotor Regions'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",93.0,0.0215557,No significant effect of individual OPRM1 promoter CpG units on AD relapse was observed in either AAs or EAs.,"[{'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania and VISN4 MIRECC, Crescenz VAMC, Philadelphia, PA, USA.'}, {'ForeName': 'Lindsay A', 'Initials': 'LA', 'LastName': 'Farrer', 'Affiliation': 'Department of Medicine (Biomedical Genetics), Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Hongqin', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Hepatology, the First Hospital of Jilin University, Jilin University, Changchun, China.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA. huipingz@bu.edu.'}]",The pharmacogenomics journal,['10.1038/s41397-020-0158-1']
3235,30266270,"Probiotic Lactobacillus plantarum P8 alleviated stress and anxiety while enhancing memory and cognition in stressed adults: A randomised, double-blind, placebo-controlled study.","BACKGROUND & AIMS


To investigate the effects of probiotic in alleviation of stress in stressed adults, along our focus to identify and justify strain specificity on selected health benefits with a precisely targeted population.
METHODS


This 12-weeks randomized, double-blind and placebo-controlled study investigated the effects of a probiotic (Lactobacillus plantarum P8; 10 log CFU daily) on psychological, memory and cognition parameters in one hundred and three (P8 n = 52, placebo n = 51) stressed adults with mean age of 31.7 ± 11.1 years old. All subjects fulfilled the criteria of moderate stress upon diagnosis using the PSS-10 questionnaire.
RESULTS


At the end of study, subjects on P8 showed reduced scores of stress (mean difference 2.94; 95% CI 0.08 to 5.73; P = 0.048), anxiety (mean difference 2.82; 95% CI 0.35 to 5.30; P = 0.031) and total score (mean difference 8.04; 95% CI 0.73 to 15.30; P = 0.041) as compared to placebo after 4-weeks, as assessed by the DASS-42 questionnaire. Although plasma cortisol levels were only marginally different between placebo and P8 (mean difference 3.28 ug/dl; 95% CI -7.09 to 0.52; P = 0.090), pro-inflammatory cytokines such as IFN-γ (mean difference 8.07 pg/ml; 95% CI -11.2 to -4.93; P < 0.001) and TNF-α (mean difference 1.52 pg/ml; 95% CI -2.14 to -0.89; P < 0.001) showed higher reduction as compared to placebo over 12-weeks. These were accompanied by enhanced memory and cognitive traits such as social emotional cognition and verbal learning and memory upon administration of P8 as compared to the placebo, with different effects in women as compared to men.
CONCLUSIONS


The present data illustrated that L. plantarum P8 is a feasible and natural intervention for the alleviation of selected stress, anxiety, memory and cognitive symptoms in stressed adults.
TRIAL REGISTRATION


Approved by the JEPeM-USM Review Panel on Clinical Studies (Approval number USM/JEPeM/16050195) and was registered at ClinicalTrials.gov (identifier number NCT03268447).",2019,"At the end of study, subjects on P8 showed reduced scores of stress (mean difference 2.94; 95% CI 0.08 to 5.73; P = 0.048), anxiety (mean difference 2.82; 95% CI 0.35 to 5.30; P = 0.031) and total score (mean difference 8.04; 95% CI 0.73 to 15.30; P = 0.041) as compared to placebo after 4-weeks, as assessed by the DASS-42 questionnaire.","['stressed adults', 'one hundred and three (P8 n\xa0=\xa052, placebo n\xa0=\xa051) stressed adults with mean age of 31.7\xa0±\xa011.1 years old']","['probiotic', 'Probiotic Lactobacillus plantarum P8', 'probiotic (Lactobacillus plantarum P8', 'placebo']","['enhanced memory and cognitive traits such as social emotional cognition and verbal learning and memory upon administration of P8', 'stress and anxiety while enhancing memory and cognition', 'TNF-α', 'pro-inflammatory cytokines such as IFN-γ', 'plasma cortisol levels', 'anxiety', 'psychological, memory and cognition parameters', 'scores of stress', 'total score']","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4708784', 'cui_str': '31.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.612711,"At the end of study, subjects on P8 showed reduced scores of stress (mean difference 2.94; 95% CI 0.08 to 5.73; P = 0.048), anxiety (mean difference 2.82; 95% CI 0.35 to 5.30; P = 0.031) and total score (mean difference 8.04; 95% CI 0.73 to 15.30; P = 0.041) as compared to placebo after 4-weeks, as assessed by the DASS-42 questionnaire.","[{'ForeName': 'Lee-Ching', 'Initials': 'LC', 'LastName': 'Lew', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, 11800, Penang, Malaysia.'}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Hor', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, 11800, Penang, Malaysia.'}, {'ForeName': ""Nur Asmaa' A"", 'Initials': 'NAA', 'LastName': 'Yusoff', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Malaysia.'}, {'ForeName': 'Sy-Bing', 'Initials': 'SB', 'LastName': 'Choi', 'Affiliation': 'School of Data Sciences, Perdana University, 43400, Serdang, Malaysia.'}, {'ForeName': 'Muhamad S B', 'Initials': 'MSB', 'LastName': 'Yusoff', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Malaysia.'}, {'ForeName': 'Nurhanis S', 'Initials': 'NS', 'LastName': 'Roslan', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Malaysia.'}, {'ForeName': 'Anisa', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Malaysia.'}, {'ForeName': 'Jamilah A M', 'Initials': 'JAM', 'LastName': 'Mohammad', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Malaysia.'}, {'ForeName': 'Mohammad Farris I L', 'Initials': 'MFIL', 'LastName': 'Abdullah', 'Affiliation': 'Advanced Medical and Dental Institute, Universiti Sains Malaysia, Bertam, Malaysia.'}, {'ForeName': 'Norzila', 'Initials': 'N', 'LastName': 'Zakaria', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, 16150, Kubang Kerian, Malaysia.'}, {'ForeName': 'Normala', 'Initials': 'N', 'LastName': 'Wahid', 'Affiliation': 'Community Health Center, Universiti Sains Malaysia, 11800, Penang, Malaysia.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education, Inner Mongolia Agricultural University, Hohhot, Inner Mongolia, 010018, China.'}, {'ForeName': 'Lai-Yu', 'Initials': 'LY', 'LastName': 'Kwok', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education, Inner Mongolia Agricultural University, Hohhot, Inner Mongolia, 010018, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Dairy Biotechnology and Engineering, Ministry of Education, Inner Mongolia Agricultural University, Hohhot, Inner Mongolia, 010018, China. Electronic address: hepingdd@vip.sina.com.'}, {'ForeName': 'Min-Tze', 'Initials': 'MT', 'LastName': 'Liong', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, 11800, Penang, Malaysia. Electronic address: mintze.liong@usm.my.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.09.010']
3236,22467902,Correlation of treatment-emergent adverse events and clinical response to endocrine therapy in early breast cancer: a retrospective analysis of the German cohort of TEAM.,"BACKGROUND


Previous studies have suggested a correlation between the occurrence of vasomotor or joint symptoms during tamoxifen or aromatase inhibitor treatment and improved clinical response.
PATIENTS AND METHODS


A retrospective analysis of the German cohort of the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial was carried out to assess disease-free survival (DFS) and overall survival (OS) in patients with and without arthralgia/myalgia and/or menopausal symptoms during adjuvant endocrine treatment.
RESULTS


A total of 1502 patients were included; 739 patients received tamoxifen followed by exemestane and 763 received exemestane. Patients reporting arthralgia/myalgia and patients reporting menopausal symptoms during endocrine treatment had significantly longer OS and DFS than those not reporting these events. The effect on OS was irrespective of treatment. DFS was significantly improved in exemestane-treated patients reporting arthralgia/myalgia or those reporting menopausal symptoms versus those not reporting these events. This effect on DFS was not observed in patients receiving sequential treatment. A combined analysis of patients reporting either menopausal symptoms or arthralgia/myalgia showed that OS and DFS were significantly improved in patients reporting one of these symptoms versus those not reporting either symptom.
CONCLUSION


The occurrence of arthralgia/myalgia or menopausal symptoms during endocrine treatment is associated with significantly improved OS.",2012,DFS was significantly improved in exemestane-treated patients reporting arthralgia/myalgia or those reporting menopausal symptoms versus those not reporting these events.,"['patients with and without arthralgia/myalgia and/or menopausal symptoms during adjuvant endocrine treatment', 'A total of 1502 patients were included; 739 patients received', 'patients receiving sequential treatment', 'early breast cancer']","['tamoxifen or aromatase inhibitor', 'endocrine therapy', 'tamoxifen followed by exemestane', 'Tamoxifen Exemestane', 'exemestane']","['arthralgia/myalgia', 'disease-free survival (DFS) and overall survival (OS', 'occurrence of arthralgia/myalgia or menopausal symptoms', 'menopausal symptoms or arthralgia/myalgia', 'longer OS and DFS', 'DFS', 'OS and DFS', 'menopausal symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}]","[{'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}]",1502.0,0.116668,DFS was significantly improved in exemestane-treated patients reporting arthralgia/myalgia or those reporting menopausal symptoms versus those not reporting these events.,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hadji', 'Affiliation': 'Departments of Gynaecological Endocrinology, Reproductive Medicine and Osteoporosis, University Hospital of Giessen and Marburg, Marburg. Electronic address: hadji@med.uni-marburg.de.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Kieback', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elblandkliniken, Meissen.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tams', 'Affiliation': 'Biostatistics Department, ICRC-Weyer GmbH, Berlin.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hasenburg', 'Affiliation': 'Department of Gynaecology and Gynaecologic Oncology, University Hospital Freiburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ziller', 'Affiliation': 'Departments of Gynaecological Endocrinology, Reproductive Medicine and Osteoporosis, University Hospital of Giessen and Marburg, Marburg.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds055']
3237,31953863,"Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder.","OBJECTIVE


To evaluate the dose-response relationship of daridorexant, a new dual orexin receptor antagonist, on sleep variables in subjects with insomnia disorder.
METHODS


Adults (≤64 years) with insomnia disorder were randomized (1:1:1:1:1:1) to receive daily oral placebo, daridorexant (5, 10, 25, or 50mg), or 10mg zolpidem for 30 days. The primary efficacy outcome was the change in wake time after sleep onset from baseline to days 1 and 2. Secondary outcome measures were change in latency to persistent sleep from baseline to days 1 and 2, change in subjective wake time after sleep onset, and subjective latency to sleep onset from baseline to week 4. Safety was also assessed.
RESULTS


Of 1,005 subjects screened, 359 (64% female) were randomized and received ≥1 dose. A significant dose-response relationship (multiple comparison procedure-modeling, 2-sided p < 0.001) was found in the reduction of wake after sleep onset and latency to persistent sleep from baseline to days 1 and 2 with daridorexant. These reductions were sustained through to days 28 and 29 (p = 0.050 and p = 0.042, respectively). Similar dose-dependent relationships were observed for subjective wake after sleep onset and subjective latency to sleep onset. The incidence of treatment-emergent adverse events was 35%, 38%, 38%, and 34% in subjects treated with 5, 10, 25, and 50mg daridorexant, respectively, compared with 30% for placebo, and 40% for 10mg zolpidem. There were no clinically relevant treatment-related serious adverse events. Four subjects withdrew due to adverse events.
INTERPRETATION


Daridorexant induced a dose-dependent reduction in wake time after sleep onset in subjects with insomnia disorder (Clinicaltrials.gov NCT02839200). Ann Neurol 2020;87:347-356.",2020,"These reductions were sustained through to Days 28&29 (p=0.050 and p=0.042, respectively).","['Adults (≤64\u2009years) with insomnia disorder', 'subjects with insomnia disorder', 'Of 1005 subjects screened, 359 (64% female']","['placebo', 'zolpidem', 'daily oral placebo, daridorexant', 'daridorexant']","['change in wake time after sleep onset', 'subjective wake after sleep onset and subjective latency to sleep onset', 'reduction of wake after sleep onset and latency to persistent sleep', 'incidence of treatment-emergent adverse events', 'change in latency to persistent sleep from baseline to Days 1&2, change in subjective wake time after sleep onset and subjective latency to sleep onset', 'Safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1005.0,0.217756,"These reductions were sustained through to Days 28&29 (p=0.050 and p=0.042, respectively).","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Sleep Unit, Department of Neurology, Neuropsychiatry: Epidemiological and Clinical Research, University of Montpellier, National Institute of Health and Medical Research, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation and Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Fietze', 'Affiliation': 'Center of Interdisciplinary Sleep Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mayleben', 'Affiliation': 'CTI Clinical Research Center, Cincinnati, OH.'}, {'ForeName': 'Dalma', 'Initials': 'D', 'LastName': 'Seboek Kinter', 'Affiliation': 'Clinical Development, Idorsia Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Pain', 'Affiliation': 'Clinical Development, Idorsia Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}]",Annals of neurology,['10.1002/ana.25680']
3238,22910840,The impact of second to sixth line therapy on survival of relapsed ovarian cancer after primary taxane/platinum-based therapy.,"BACKGROUND


Despite recent progress in the treatment of ovarian cancer, the majority of patients eventually relapse. There is little information on the effectiveness of chemotherapy in higher treatment lines.
PATIENTS AND METHODS


Characterization of the second to sixth line therapy and its effects on survival was carried out, based on data of n = 1620 patients from three large randomized phase III trials investigating primary therapy.
RESULTS


Median progression-free survival (PFS) after the first, second, third, fourth and fifth relapse was 10.2 [95% confidence interval (CI) 9.6-10.7], 6.4 (5.9-7.0), 5.6 (4.8-6.2), 4.4 (3.7-4.9) and 4.1 (3.0-5.1) months, respectively. Median overall survival (OS) after the first, second, third, fourth and fifth relapse was 17.6 (95% CI 16.4-18.6), 11.3 (10.4-12.9), 8.9 (7.8-9.9), 6.2 (5.1-7.7) and 5.0 (3.8-10.4) months, respectively. The most frequent second and third line chemotherapy was platinum combination (n = 313, 24.5%) and topotecan (n = 118, 23.6%), respectively. Relapse treatment improved PFS and OS at the second to fourth recurrence, although frequently not performed according to the standard of care. In multivariate analysis, platinum sensitivity and optimal primary tumor debulking were revealed as independent prognostic factors for PFS up to third relapse.
CONCLUSION


A maximum of three lines of subsequent relapse treatment seems to be beneficial for patients with recurrent ovarian cancer. Optimal primary tumor debulking and platinum sensitivity remain independent prognostic factors even after more frequent relapses.",2012,"Relapse treatment improved PFS and OS at the second to fourth recurrence, although frequently not performed according to the standard of care.","['n = 1620 patients from three large randomized phase III trials investigating primary therapy', 'patients with recurrent ovarian cancer']","['topotecan', 'sixth line therapy', 'primary taxane/platinum-based therapy']","['Median overall survival (OS', 'PFS and OS', 'Median progression-free survival (PFS', 'survival of relapsed ovarian cancer']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0205440', 'cui_str': 'Sixth (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]",1620.0,0.0838504,"Relapse treatment improved PFS and OS at the second to fourth recurrence, although frequently not performed according to the standard of care.","[{'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Hanker', 'Affiliation': 'Department of Gynecology and Obstetrics, Johann Wolfgang Goethe-University, Frankfurt am Main. Electronic address: hanker@med.uni-frankfurt.de.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group Forschungs GmbH, Neu Isenburg, Department of Gynecology and Obstetrics Klinikum Offenbach, Offenbach am Main.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Burchardi', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps-University, Marburg.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pfisterer', 'Affiliation': 'Department of Gynecology and Obstetrics, Städtisches Klinikum, Solingen.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Meier', 'Affiliation': 'Department of Gynecology and Obstetrics, Evangelical Hospital, Duesseldorf, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': 'Department of Oncology, Hôpital Hôtel-Dieu, Paris.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Department of Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynecology, Charité/Campus Virchow Klinikum Medical University, Berlin.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds203']
3239,31998802,14-CpG-Based Signature Improves the Prognosis Prediction of Hepatocellular Carcinoma Patients.,"Background


Epigenetic dysregulation via alteration of DNA methylation often occurs during the development and progression of cancer, including hepatocellular carcinoma (HCC). In the past, many patterns of single-gene DNA methylation have been extensively explored in the context of HCC prognosis prediction. However, the combined model of a mixture of CpGs has rarely been evaluated. In the present study, we aimed to develop and validate a CpG-based signature model for HCC patient prognosis.
Methods


Data from methylation profiling of GSE73003, GSE37988, and GSE57958 from the Gene Expression Omnibus (GEO) database and 371 HCC patients from the Cancer Genome Atlas (TCGA) were downloaded. The 371 HCC patients were randomly divided into a development cohort ( N  = 263) and a validation cohort ( N  = 263) and a validation cohort (.
Results


Fourteen differential CpGs associated with OS were identified in HCC patients. The MSH, based on these 14 differential CpGs, could effectively divide HCC patients into two distinct subgroups with high risk or low risk of death ( P  < 0.0001) in the development cohort (26.35 vs 83.18 months, HR = 3.83, 95% CI: 2.56-5.90,  P  < 0.0001) in the development cohort (26.35 vs 83.18 months, HR = 3.83, 95% CI: 2.56-5.90,  P  < 0.0001) in the development cohort (26.35 vs 83.18 months, HR = 3.83, 95% CI: 2.56-5.90.
Conclusion


The 14-CpG-based signature is significantly associated with OS and may be used as a novel prognostic biomarker for HCC patients.",2020,The 14-CpG-based signature is significantly associated with OS and may be used as a novel prognostic biomarker for HCC patients.,"['371 HCC patients', '371 HCC patients from the Cancer Genome Atlas (TCGA', 'Hepatocellular Carcinoma Patients']",['14-CpG-Based Signature'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0004171', 'cui_str': 'Atlases'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}]",[],371.0,0.0572849,The 14-CpG-based signature is significantly associated with OS and may be used as a novel prognostic biomarker for HCC patients.,"[{'ForeName': 'Hong-Ye', 'Initials': 'HY', 'LastName': 'Jiang', 'Affiliation': ""Department of Clinical Laboratory, Shunde Hospital, Southern Medical University (the First People's Hospital of Shunde), Foshan 528300, Guangdong Province, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Ning', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510630, Guangdong Province, China.'}, {'ForeName': 'Yen-Sheng', 'Initials': 'YS', 'LastName': 'Wang', 'Affiliation': 'Department of Environmental Health Science, Yale School of Public Health, New Haven, Connecticut, USA.'}, {'ForeName': 'Wei-Biao', 'Initials': 'WB', 'LastName': 'Lv', 'Affiliation': ""Department of Clinical Laboratory, Shunde Hospital, Southern Medical University (the First People's Hospital of Shunde), Foshan 528300, Guangdong Province, China.""}]",BioMed research international,['10.1155/2020/9762067']
3240,22431701,FOXP3 expression in cancer cells and anthracyclines efficacy in patients with primary breast cancer treated with adjuvant chemotherapy in the phase III UNICANCER-PACS 01 trial.,"BACKGROUND


Predictive markers of response to chemotherapy are lacking in breast cancer patients. Forkhead Box Protein 3 (FOXP3) is an anti-oncogene whose absence in cancer cells could confer resistance to DNA damaging agent. So we made the hypothesis that FOXP3 expression predicts the response to anthracyclines in breast cancer patients and that adjuvant chemotherapy adding taxanes to anthracyclines confers an overall survival (OS) benefit over anthracyclines alone, in patients with FOXP3-negative tumors.
PATIENTS AND METHODS


Expression of FOXP3 in cancer cells was evaluated by immunohistochemistry in tumor samples from 1097 patients who participated in the PACS01 randomized trial that evaluated in adjuvant setting the adjunction of docetaxel (Taxotere) to anthracyclines in patients with localized breast cancer. Kaplan-Meier analysis and Cox regression model were used to assess OS according to the presence or absence of FOXP3 expression in tumor cells.
RESULTS


Four hundred and five tumors were found to express FOXP3 (37%). FOXP3 expression in breast cancer cells was associated with better OS (P = 0.003). Uni- and multivariate survival analyses according to treatment arm revealed that FOXP3 expression in breast cancer cells is independently associated with improved OS in patients treated with anthracycline-based adjuvant chemotherapy, but not in patients treated with sequential anthracycline-taxane. Moreover, in vitro experiments showed that FOXP3 induction in breast cancer cell lines using histone deacetylase inhibitor enhances anthracyclines efficacy.
CONCLUSION


FOXP3 expression in tumor cells may be an accurate predictive biomarker of anthracycline efficacy in breast cancer.",2012,FOXP3 expression in breast cancer cells was associated with better OS (P = 0.003).,"['Expression of FOXP3 in cancer cells was evaluated by immunohistochemistry in tumor samples from 1097 patients who participated in the PACS01 randomized trial that evaluated in adjuvant setting the adjunction of', 'breast cancer patients', 'patients with localized breast cancer', 'patients with primary breast cancer treated with', 'patients with FOXP3-negative tumors']","['adjuvant chemotherapy', 'sequential anthracycline-taxane', 'docetaxel (Taxotere) to anthracyclines', 'anthracycline-based adjuvant chemotherapy', 'Forkhead Box Protein 3 (FOXP3']","['FOXP3 expression in cancer cells and anthracyclines efficacy', 'FOXP3 expression', 'overall survival (OS) benefit']","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0118111', 'cui_str': 'Forkhead Transcription Factors'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1097.0,0.0314235,FOXP3 expression in breast cancer cells was associated with better OS (P = 0.003).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ladoire', 'Affiliation': 'Department of Medical Oncology. Centre Georges-François Leclerc, Dijon; Institut National de la Santé et de la Recherche Médicale, Avenir Team INSERM, CRI-866 University of Burgundy, Dijon.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mignot', 'Affiliation': 'Institut National de la Santé et de la Recherche Médicale, Avenir Team INSERM, CRI-866 University of Burgundy, Dijon.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dalban', 'Affiliation': 'Biostatistics and Epidemiological Unit, EA 4184, Dijon.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chevriaux', 'Affiliation': 'Department of Medical Oncology. Centre Georges-François Leclerc, Dijon; Institut National de la Santé et de la Recherche Médicale, Avenir Team INSERM, CRI-866 University of Burgundy, Dijon.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Arnould', 'Affiliation': 'Department of Pathology and Biology of Tumors.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rébé', 'Affiliation': 'Department of Medical Oncology. Centre Georges-François Leclerc, Dijon; Institut National de la Santé et de la Recherche Médicale, Avenir Team INSERM, CRI-866 University of Burgundy, Dijon.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Apetoh', 'Affiliation': 'Department of Medical Oncology. Centre Georges-François Leclerc, Dijon; Institut National de la Santé et de la Recherche Médicale, Avenir Team INSERM, CRI-866 University of Burgundy, Dijon.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Boidot', 'Affiliation': 'Molecular Genetics Laboratory, Centre Georges François Leclerc, Dijon.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Penault-Llorca', 'Affiliation': 'Department of Pathology, Centre Jean Perrin, Clermont Ferrand.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fumoleau', 'Affiliation': 'Department of Medical Oncology. Centre Georges-François Leclerc, Dijon.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Roché', 'Affiliation': 'Department of Medical Oncology, Institut Claudius Regaud, Toulouse.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Spielmann', 'Affiliation': 'Department of Medicine and Translational Research Unit, Institut Gustave Roussy, Villejuif.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Department of Medical Oncology, Centre François Baclesse, Caen.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lortholary', 'Affiliation': 'Department of Medical Oncology, Centre Paul Papin, Angers.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Eichler', 'Affiliation': 'Department of Medical Oncology; Hopital Civil, Strasbourg.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mesleard', 'Affiliation': 'Comité sein (PACS), UNICANCER, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bonnetain', 'Affiliation': 'Biostatistics and Epidemiological Unit, EA 4184, Dijon.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ghiringhelli', 'Affiliation': 'Department of Medical Oncology. Centre Georges-François Leclerc, Dijon; Institut National de la Santé et de la Recherche Médicale, Avenir Team INSERM, CRI-866 University of Burgundy, Dijon. Electronic address: fghiringhelli@cgfl.fr.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds028']
3241,22431703,Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004).,"BACKGROUND


This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases.
METHODS


This phase II study, originally started as a phase III design, randomly assigned 119 patients with non-resectable colorectal liver metastases between systemic treatment (n = 59) or systemic treatment plus RFA ( ± resection) (n = 60). Primary objective was a 30-month overall survival (OS) rate >38% for the combined treatment group.
RESULTS


The primary end point was met, 30-month OS rate was 61.7% [95% confidence interval (CI) 48.2-73.9] for combined treatment. However, 30-month OS for systemic treatment was 57.6% (95% CI 44.1-70.4), higher than anticipated. Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22). PFS rate at 3 years for combined treatment was 27.6% compared with 10.6% for systemic treatment only (hazard ratio = 0.63, 95% CI 0.42-0.95, P = 0.025). Median progression-free survival (PFS) was 16.8 months (95% CI 11.7-22.1) and 9.9 months (95% CI 9.3-13.7), respectively.
CONCLUSIONS


This is the first randomized study on the efficacy of RFA. The study met the primary end point on 30-month OS; however, the results in the control arm were in the same range. RFA plus systemic treatment resulted in significant longer PFS. At present, the ultimate effect of RFA on OS remains uncertain.",2012,Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22).,"['patients with non-resectable colorectal liver metastases', '119 patients with non-resectable colorectal liver metastases between systemic treatment (n = 59) or']","['radiofrequency ablation (RFA', 'systemic treatment plus RFA ( ± resection', 'Radiofrequency ablation combined with systemic treatment', 'RFA']","['30-month overall survival (OS) rate', 'PFS rate', 'Median OS', 'PFS', 'Median progression-free survival (PFS', '30-month OS rate', '30-month OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",119.0,0.121278,Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22).,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruers', 'Affiliation': 'Department of Surgery, The Netherlands Cancer Institute-Antoni Van Leeuwenhoek ziekenhuis, Amsterdam. Electronic address: T.Ruers@NKI.nl.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Academic Medical Centre, University of Amsterdam, Amsterdam.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Van Coevorden', 'Affiliation': 'Department of Surgery, The Netherlands Cancer Institute-Antoni Van Leeuwenhoek ziekenhuis, Amsterdam.'}, {'ForeName': 'J P E N', 'Initials': 'JPEN', 'LastName': 'Pierie', 'Affiliation': 'Department of Surgery, Leeuwarden Medical Center, Leeuwarden.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Borel-Rinkes', 'Affiliation': 'Department of Surgery, Universitair Medisch Centrum, Utrecht, The Netherlands.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL and UCL Hospitals Comprehensive Biomedical Research Centre, University College London, London.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Poston', 'Affiliation': 'Department of Surgery, Aintree University Hospital, Liverpool, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bechstein', 'Affiliation': 'Department of Surgery, Klinikum Der J.W. Goethe Universitaet, Frankfurt, Germany.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Lentz', 'Affiliation': 'Data Management Unit, EORTC Headquarters, Brussels.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mauer', 'Affiliation': 'Statistics Department, EORTC Headquarters, Brussels.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Department of Medical Oncology, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Lutz', 'Affiliation': 'Department of Medical Oncology, Caritasklinik St. Theresia, Saarbrücken, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Nordlinger', 'Affiliation': 'Department of Surgery, Centre Hospitalier Universitaire Ambroise Paré, Assistance Publique Hôpitaux de Paris, Boulogne-Billancourt, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds053']
3242,31913908,Estimating Serotype-specific Efficacy of Pneumococcal Conjugate Vaccines Using Hierarchical Models.,"Pneumococcal conjugate vaccines target 10 or 13 specific serotypes. To evaluate the overall efficacy of these products, the vaccine-targeted serotypes are typically aggregated into a single group. However, it is often desirable to evaluate variations in effects for different serotypes. These serotype-specific estimates are often based on small counts, resulting in a high degree of uncertainty (i.e., large standard errors and wide confidence intervals). An alternative is to use a hierarchical Bayesian statistical model, which estimates overall effectiveness while simultaneously providing estimates of serotype-specific vaccine effects. These shrunken serotype-specific estimators often have smaller mean squared errors (MSEs) than unbiased versions due to a large decrease in posterior uncertainty. We reanalyzed published data from a randomized controlled trial on the efficacy of 13-valent pneumococcal conjugate vaccine (PCV13) against community-acquired pneumonia caused by vaccine-targeted serotype using a hierarchical model. This model provides a potential framework for obtaining estimates of serotype-specific vaccine effects with reduced MSEs.",2020,These shrunken serotype-specific estimators often have smaller mean squared errors (MSEs) than unbiased versions due to a large decrease in posterior uncertainty.,[],"['pneumococcal conjugate vaccines', 'PCV13']",[],[],"[{'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]",[],,0.0541208,These shrunken serotype-specific estimators often have smaller mean squared errors (MSEs) than unbiased versions due to a large decrease in posterior uncertainty.,"[{'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Warren', 'Affiliation': 'From the Department of Biostatistics, Yale School of Public Health, New Haven, CT.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Weinberger', 'Affiliation': 'Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT.'}]","Epidemiology (Cambridge, Mass.)",['10.1097/EDE.0000000000001135']
3243,32015491,"Clinical significance of TP53, BIRC3, ATM and MAPK-ERK genes in chronic lymphocytic leukaemia: data from the randomised UK LRF CLL4 trial.","Despite advances in chronic lymphocytic leukaemia (CLL) treatment, globally chemotherapy remains a central treatment modality, with chemotherapy trials representing an invaluable resource to explore disease-related/genetic features contributing to long-term outcomes. In 499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations. After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1). Mutations beyond Sanger resolution (<12% VAF) were observed in all genes, with KRAS mutations principally composed of these low VAF variants. Firstly, employing orthogonal approaches to confirm <12% VAF TP53 mutations, we assessed the clinical impact of TP53 clonal architecture. Whilst ≥ 12% VAF TP53mut cases were associated with reduced PFS and OS, we could not demonstrate a difference between <12% VAF TP53 mutations and either wild type or ≥12% VAF TP53mut cases. Secondly, we identified biallelic BIRC3 lesions (mutation and deletion) as an independent marker of inferior PFS and OS. Finally, we observed that mutated MAPK-ERK genes were independent markers of poor OS in multivariate survival analysis. In conclusion, our study supports using targeted resequencing of expanded gene panels to elucidate the prognostic impact of gene mutations.",2020,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","['chronic lymphocytic leukaemia (CLL', 'chronic lymphocytic leukaemia', '499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations']",[],"['PFS and OS', 'Mutations beyond Sanger resolution', 'biallelic BIRC3 lesions (mutation and deletion']","[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]",[],"[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}]",,0.0594031,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","[{'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Blakemore', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Clifford', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parker', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Antoniou', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Stec-Dziedzic', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Larrayoz', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Zadie', 'Initials': 'Z', 'LastName': 'Davis', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Kadalyayil', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Colins', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Robbe', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Vavoulis', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Carr', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Morilla', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Else', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Bryant', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Renata J', 'Initials': 'RJ', 'LastName': 'Walewska', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Steele', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Speight', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Stankovic', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Services, IBR West, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Cragg', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catovsky', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Oscier', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Matthew J J', 'Initials': 'MJJ', 'LastName': 'Rose-Zerilli', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Strefford', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK. jcs@soton.ac.uk.'}]",Leukemia,['10.1038/s41375-020-0723-2']
3244,31864809,Impact of Deep Learning-based Optimization Algorithm on Image Quality of Low-dose Coronary CT Angiography with Noise Reduction: A Prospective Study.,"RATIONALE AND OBJECTIVES


To evaluate deep learning (DL)-based optimization algorithm for low-dose coronary CT angiography (CCTA) image noise reduction and image quality (IQ) improvement.
MATERIALS AND METHODS


A postprocessing platform for the CCTA image was built using a DL-based algorithm. Seventy subjects referred for CCTA were randomly divided into two groups (study group A with 80 kVp and control group B with 100 kVp). Group C was obtained by DL optimization of group A. Subjective IQ was blindly graded by two experienced radiologists on a four-point scale (4-excellent,1-poor). The image noise, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) were calculated to evaluate IQ objectively. The difference between the time consumed of iterative reconstruction and DL algorithm was also recorded.
RESULTS


The subjective IQ score of group C using the DL algorithm was significantly better than that of group A (p = 0.005). The noise of group C was significantly decreased, while SNR and CNR were significantly increased compared to group A (p < 0.001). The subjective IQ scores were lower in group A compared to group B (p = 0.037), whereas subjective IQ scores in group C were not significantly different (p = 0.874). For objective IQ, the noise of group A was significantly higher, while SNR and CNR were significantly lower than that of group B (p < 0.05). There was no significant difference in noise and SNR between group C and group B (p > 0.05), but CNR in group C was significantly higher than that in group B (p < 0.05). The DL algorithm processes the image twice as fast as the iterative reconstruction speed.
CONCLUSION


The DL-based optimization algorithm could effectively improve the IQ of low-dose CCTA by noise reduction.",2020,"The subjective IQ scores were lower in group A compared to group B (p = 0.037), whereas subjective IQ scores in group C were not significantly different (p = 0.874).",['Seventy subjects referred for CCTA'],"['Deep Learning-based Optimization Algorithm', 'Low-dose Coronary CT Angiography with Noise Reduction', 'deep learning (DL)-based optimization algorithm for low-dose coronary CT angiography (CCTA']","['subjective IQ scores', 'SNR and CNR', 'noise and SNR', 'image noise, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR', 'subjective IQ score']","[{'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002045'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",70.0,0.0118137,"The subjective IQ scores were lower in group A compared to group B (p = 0.037), whereas subjective IQ scores in group C were not significantly different (p = 0.874).","[{'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.'}, {'ForeName': 'Yining', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China. Electronic address: wangyining@pumch.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'CT Business Unit, Neusoft Medical System Company, Shenyang, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.'}, {'ForeName': 'Zhuoheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'CT Business Unit, Neusoft Medical System Company, Shenyang, China.'}, {'ForeName': 'Yumei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.'}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.'}]",Academic radiology,['10.1016/j.acra.2019.11.010']
3245,31557450,Does Including Dexmedetomidine Improve Outcomes After Intravenous Sedation for Outpatient Dentoalveolar Surgery?,"PURPOSE


Dexmedetomidine represents an intriguing adjunct to outpatient intravenous (IV) sedation owing to its decreased risk of respiratory depression. The purpose of the present study was to measure the incremental effect of incorporating dexmedetomidine (DXM) into an established IV sedation regimen compared with control IV sedation without the DXM infusion.
MATERIALS AND METHODS


We designed a prospective, controlled trial in which American Society of Anesthesiologists Class 1 and 2 patients requiring both maxillary and mandibular dentoalveolar surgery would undergo 2 sedation appointments: 1 arch treated with surgery with control sedation (DXM-) using midazolam, fentanyl, and propofol as needed, and a second surgery on the opposite arch using the experimental sedation regimen (DXM+) of midazolam, fentanyl, and propofol, as needed, and a DXM infusion at 4 μg/kg/hr. The surgeon was the same for every appointment, and the patients were kept unaware regarding which sedation had included the experimental regimen. Whether the experimental sedation was used at the first or second surgery was randomized. The primary measured outcomes were efficiency in terms of anesthesia time for each sedation, the physiologic response in terms of vital signs, and the subjective patient experience.
RESULTS


A total of 12 patients completed the trial. With DXM-, the patients had significantly shorter total (∼15 minutes) and adjusted anesthesia (∼10 minutes) times. With DXM+, the patients had significantly lower average systolic blood pressure (SBP), SBP low values, diastolic blood pressure (DBP) low values, average heart rate (HR), and HR low values. None of the other continuous patient outcomes differed significantly between the 2 groups. Of the 12 patients, 10 (83.3%) reported that they preferred the experimental sedation experience with DXM (95% confidence interval, 0.52 to 0.98).
CONCLUSIONS


Using a DXM infusion with outpatient dentoalveolar surgery allowed for acceptable levels of sedation, greater patient satisfaction, and longer anesthesia and appointment times and often resulted in lower BP and heart rate.",2020,"With DXM-, the patients had significantly shorter total (∼15 minutes) and adjusted anesthesia (∼10 minutes) times.",['12 patients completed the trial'],"['midazolam, fentanyl, and propofol', 'surgery with control sedation (DXM-) using midazolam, fentanyl, and propofol', 'dexmedetomidine (DXM', 'Dexmedetomidine']","['average systolic blood pressure (SBP), SBP low values, diastolic blood pressure (DBP) low values, average heart rate (HR), and HR low values', 'lower BP and heart rate', 'efficiency in terms of anesthesia time for each sedation, the physiologic response in terms of vital signs, and the subjective patient experience']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0518766'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.0453159,"With DXM-, the patients had significantly shorter total (∼15 minutes) and adjusted anesthesia (∼10 minutes) times.","[{'ForeName': 'D Craig', 'Initials': 'DC', 'LastName': 'Taylor', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, Augusta University, Augusta, GA. Electronic address: CraigTaylorDMD@gmail.com.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Ferguson', 'Affiliation': 'Vice Chairman and Associate Professor, Department of Oral and Maxillofacial Surgery, Augusta University, Augusta, GA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stevens', 'Affiliation': 'Chairman and Professor, Department of Oral and Maxillofacial Surgery, Augusta University, Augusta, GA.'}, {'ForeName': 'Solon', 'Initials': 'S', 'LastName': 'Kao', 'Affiliation': 'Vice Chairman and Associate Professor, Department of Oral Surgery and Hospital Dentistry, University of Missouri-Kansas City, Kansas City, MO.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Yang', 'Affiliation': 'Associate Professor, Department of Occupational Therapy, School of Health Professions, University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Looney', 'Affiliation': 'Professor, Department of Biostatistics and Data Science, Augusta University, Augusta, GA.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.08.016']
3246,31158739,Olive leaf tea is beneficial for lipid metabolism in adults with prediabetes: an exploratory randomized controlled trial.,"Olive leaves are rich in oleuropein, which has been shown to have beneficial effects on dyslipidemia, type 2 diabetes, and obesity. However, we previously found no significant health benefits of olive leaf tea (OLT) on nonobese and nondiabetic individuals. Thus, we performed this study to further explore the health benefits of OLT in individuals with prediabetes and compare the health benefits between low-concentration OLT (LOLT) and OLT. We hypothesized that OLT will have a more pronounced effect on abdominal obesity as well as glucose and lipid metabolism in prediabetic individuals. Individuals between 40 and 70 years of age with a body mass index of 23.0-29.9 kg/m 2  and prediabetes status were recruited and randomly assigned to the OLT or the LOLT group. The intervention, which was the consumption of 330 mL of the test beverage 3 times daily during mealtime, lasted for 12 weeks. After the intervention, serum levels of log-transformed triglycerides (P < .05) and low-density lipoprotein cholesterol (P < .01) decreased significantly in the OLT group (n = 28), with the reductions higher in the OLT group than those in the LOLT group (n = 29, log-transformed triglycerides: P = .079, low-density lipoprotein cholesterol: P < .05). Whereas body weight, waist circumference, and insulin levels were not significantly changed in both groups, fasting plasma glucose levels in the OLT group were significantly decreased compared to those in the LOLT group (P < .05). In conclusion, although the effect of OLT on abdominal obesity and glucose metabolism remains unclear, OLT has been found to have lipid-lowering effects.",2019,"After the intervention, serum levels of log-transformed triglycerides (P < .05) and low-density lipoprotein cholesterol (P < .01) decreased significantly in the OLT group (n = 28), with the reductions higher in the OLT group than those in the LOLT group (n = 29, log-transformed triglycerides:","['nonobese and nondiabetic individuals', 'adults with prediabetes', 'prediabetic individuals', 'Individuals between 40 and 70\u202fyears of age with a body mass index of 23.0-29.9\u202fkg/m 2  and prediabetes status', 'individuals with prediabetes']","['OLT', 'OLT or the LOLT', 'Olive leaf tea', 'olive leaf tea (OLT', 'LOLT']","['body weight, waist circumference, and insulin levels', 'fasting plasma glucose levels', 'serum levels of log-transformed triglycerides', 'low-density lipoprotein cholesterol', 'lipid metabolism', 'abdominal obesity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0228539', 'cui_str': 'Nucleus Basalis, Olivary'}, {'cui': 'C0242724', 'cui_str': 'Plant Leaves'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}]",,0.0505789,"After the intervention, serum levels of log-transformed triglycerides (P < .05) and low-density lipoprotein cholesterol (P < .01) decreased significantly in the OLT group (n = 28), with the reductions higher in the OLT group than those in the LOLT group (n = 29, log-transformed triglycerides:","[{'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Araki', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. Electronic address: risa.araki@md.tsukuba.ac.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Fujie', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. Electronic address: k-fujie@md.tsukuba.ac.jp.'}, {'ForeName': 'Nanako', 'Initials': 'N', 'LastName': 'Yuine', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan; Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki, Japan. Electronic address: s1721330@s.tsukuba.ac.jp.'}, {'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Watabe', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan; Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki, Japan. Electronic address: s1721331@s.tsukuba.ac.jp.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakata', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. Electronic address: nakata.yoshio.gn@u.tsukuba.ac.jp.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Internal Medicine, Metabolism and Endocrinology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. Electronic address: hirosuzu@md.tsukuba.ac.jp.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Isoda', 'Affiliation': 'Faculty of Life and Environmental Sciences, University of Tsukuba, Ibaraki, Japan. Electronic address: isoda.hiroko.ga@u.tsukuba.ac.jp.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. Electronic address: koichi.hashimoto@md.tsukuba.ac.jp.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2019.05.003']
3247,22875835,Reply to FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer-subgroup analysis of patients with KRAS-mutated tumours in the randomised German AIO study KRK-0306.,,2012,,['patients with metastatic colorectal cancer-subgroup analysis of patients with KRAS-mutated tumours'],['FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",[],,0.0358387,,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Medical Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan. Electronic address: filippo.pietrantonio@istitutotumori.mi.it.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Medical Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Medical Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds332']
3248,31806073,Comparing Resource Management Skills in a High- versus Low-Resource Simulation Scenario: A Pilot Study.,"BACKGROUND


Low-resource environments, such as those found in humanitarian crises, pose significant challenges to the provision of proper medical treatment. While the lack of training of health providers to such settings has been well-acknowledged in literature, there has yet to be any scientific evidence for this phenomenon.
METHODS


This pilot study utilized a randomized crossover experimental design to examine the effects of high- versus low-resource simulated scenarios of a resuscitation of a critically ill obstetric patient on a medical doctors' performance and inter-personal skills. Ten senior residents (fifth-year post-graduate) of the Maggiore Hospital School of Medicine (Novara, NO, Italy) were included in the study.
RESULTS


Overall performance score for the high-resource setting was 5.2, as opposed to only 2.3 for the low-resource setting. The mean effect size for the overall score was 2.9 (95% CI, 1.7-4.0; P <.001). The results suggest a significant decrease in both technical (medical) and non-technical skills, such as leadership, problem solving, situation awareness, resource utilization, and communication in the low-resource environment setting. The latter finding is of special important since it was yet to be reported.
CONCLUSIONS


This pilot study suggests that untrained physicians in low-resource environments may experience a considerable setback not only to their professional performance, but also to their interpersonal skills, when deployed ill-prepared to humanitarian missions. Consequently, this may endanger the health of local populations.",2020,"The results suggest a significant decrease in both technical (medical) and non-technical skills, such as leadership, problem solving, situation awareness, resource utilization, and communication in the low-resource environment setting.","['Ten senior residents (fifth-year post-graduate) of the Maggiore Hospital School of Medicine (Novara, NO, Italy) were included in the study', 'untrained physicians in low-resource environments', ""critically ill obstetric patient on a medical doctors' performance and inter-personal skills""]",['high- versus low-resource simulated scenarios'],"['both technical (medical) and non-technical skills, such as leadership, problem solving, situation awareness, resource utilization, and communication in the low-resource environment setting']","[{'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",10.0,0.036389,"The results suggest a significant decrease in both technical (medical) and non-technical skills, such as leadership, problem solving, situation awareness, resource utilization, and communication in the low-resource environment setting.","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Ripoll Gallardo', 'Affiliation': 'CRIMEDIM - Research Center in Emergency and Disaster Medicine Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Meneghetti', 'Affiliation': 'CRIMEDIM - Research Center in Emergency and Disaster Medicine Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Franc', 'Affiliation': 'Department of Emergency Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Costa', 'Affiliation': 'CRIMEDIM - Research Center in Emergency and Disaster Medicine Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ragazzoni', 'Affiliation': 'CRIMEDIM - Research Center in Emergency and Disaster Medicine Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Moran', 'Initials': 'M', 'LastName': 'Bodas', 'Affiliation': 'CRIMEDIM - Research Center in Emergency and Disaster Medicine Università del Piemonte Orientale, Novara, Italy.'}, {'ForeName': 'Vaclav', 'Initials': 'V', 'LastName': 'Jordan', 'Affiliation': 'Department Gynaecology and Obstetrics, Schiers Hospital, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Della Corte', 'Affiliation': 'CRIMEDIM - Research Center in Emergency and Disaster Medicine Università del Piemonte Orientale, Novara, Italy.'}]",Prehospital and disaster medicine,['10.1017/S1049023X19005107']
3249,31997114,"ERG shrinks by 10% when reducing dark adaptation time to 10 min, but only for weak flashes.","PURPOSE


To compare dark-adapted (DA) ERG between 10, 15 and 20 min of dark adaptation (DA).
METHODS


In a counterbalanced random block design, 40 healthy adult subjects were dark-adapted for 10, 15 or 20 min before we recorded ERGs to nine flash strengths from 0.001 to 10.0 cd s/m 2  (dilated pupils) with a DTL-like electrode. Before and between sessions, the room was lit. Apart from choosing a wider range of stimulus strengths, and adding shorter DA times, the recordings fully complied with the ISCEV ERG Standard, namely using corneal electrodes, mydriasis and a standard DA sequence.
RESULTS


The a-wave amplitude was not affected by any adaptation condition. For the b-wave amplitude, effects of reduced DA time are stronger for weaker flashes: Reducing DA from 20 to 10 min had no measurable effect on the DA 3 ERG, but reduced the DA 0.01 b-wave significantly (p < 0.0001) to 87 ± 2% (mean ± SEM). The DA 0.001 b-wave (not part of the ISCEV ERG Standard) was more affected (down to 72 ± 4%). There was a small, but significant, increase, only for weak flashes, in a- and b-wave peak times for 20 compared to 10-min dark adaptation time.
CONCLUSION


Reducing dark adaptation time from 20 to 10 min in normal participants has no effect on the ISCEV DA 3 and DA 10 ERG. The reduction in DA 0.01 ERGs to 87 ± 2% agrees with Hamilton and Graham (Doc Ophthalmol 133:11-19, 2016. https://doi.org/10.1007/s10633-016-9554-x ) who found 90 ± 2% and with Asakawa et al. (Doc Ophthalmol 139:33-44, 2019. https://doi.org/10.1007/s10633-019-09693-8 ) who found 83%. Pending verification in pathophysiological states, the current results suggest that one might be able to correct for the 10% amplitude loss when gaining 10 min through shortened DA.",2020,Reducing dark adaptation time from 20 to 10 min in normal participants has no effect on the ISCEV DA 3 and DA 10 ERG.,['40 healthy adult subjects'],"['dark-adapted (DA) ERG between 10, 15 and 20\xa0min of dark adaptation (DA']","['Reducing dark adaptation time', 'weak flashes, in a- and b-wave peak times']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0010985', 'cui_str': 'Scotopic Adaptation'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0010985', 'cui_str': 'Scotopic Adaptation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0344323', 'cui_str': 'Flashing (disorder)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",40.0,0.0213724,Reducing dark adaptation time from 20 to 10 min in normal participants has no effect on the ISCEV DA 3 and DA 10 ERG.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bach', 'Affiliation': 'Eye Center, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. michael.bach@uni-freiburg.de.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Meroni', 'Affiliation': 'Eye Center, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany.'}, {'ForeName': 'Sven P', 'Initials': 'SP', 'LastName': 'Heinrich', 'Affiliation': 'Eye Center, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany.'}]",Documenta ophthalmologica. Advances in ophthalmology,['10.1007/s10633-020-09751-6']
3250,31673875,"Effect of Fluconazole and Itraconazole on the Pharmacokinetics of Erdafitinib in Healthy Adults: A Randomized, Open-Label, Drug-Drug Interaction Study.","BACKGROUND AND OBJECTIVES


Erdafitinib, an oral selective pan-fibroblast growth factor receptor (FGFR) kinase inhibitor, is primarily metabolized by cytochrome P450 (CYP) 2C9 and 3A4. The aim of this phase 1 study was to assess the pharmacokinetics and safety of erdafitinib in healthy participants when coadministered with fluconazole (moderate CYP2C9 and CYP3A inhibitor), and itraconazole (a strong CYP3A4 and P-glycoprotein inhibitor). The effect of CYP2C9 genotype variants (*1/*1, *1/*2, *1/*3) on the pharmacokinetics of erdafitinib was also investigated.
METHODS


In this open-label, parallel-group, single-center study, eligible healthy adults were randomized by CYP2C9 genotype to receive Treatment A (single oral dose of erdafitinib 4 mg) on day 1, Treatment B (fluconazole 400 mg/day orally) on days 1-11, or Treatment C (itraconazole 200 mg/day orally) on days 1-11. Healthy adults randomized to Treatment B and C received a single oral 4-mg dose of erdafitinib on day 5. The pharmacokinetic parameters, including mean maximum plasma concentration (C max ), area under the curve (AUC) from time 0 to 168 h (AUC 168h ), AUC from time 0 to the last quantifiable concentration (AUC last ), and AUC from time 0 to infinity (AUC ∞ ) were calculated from individual plasma concentration-time data using standard non-compartmental methods.
RESULTS


Coadministration of erdafitinib with fluconazole increased C max  of erdafitinib by approximately 21%, AUC 168h  by 38%, AUC last  by 49%, and AUC ∞  by 48% while coadministration with itraconazole resulted in no change in erdafitinib C max  and increased AUC 168h  by 20%, AUC last  by 33% and AUC ∞  by 34%. Erdafitinib exposure was comparable between participants with CYP2C9 *1/*2 or *1/*3 and with wild-type CYP2C9 genotype. The ratio of total amount of erdafitinib excreted in the urine (inhibited to non-inhibited) was 1.09, the ratio of total amount of excreted metabolite M6 was 1.21, and the ratio of the metabolite to parent ratio in the urine was 1.11, when coadministration of erdafitinib with itraconazole was compared with single-dose erdafitinib. Treatment-emergent adverse events (TEAEs) were generally Grade 1 or 2 in severity; the most commonly reported TEAE was headache. No safety concerns were identified with single-dose erdafitinib when administered alone and in combination with fluconazole or itraconazole in healthy adults.
CONCLUSION


Coadministration of fluconazole or itraconazole or other moderate/strong CYP2C9 or CYP3A4 inhibitors may increase exposure to erdafitinib in healthy adults and thus may warrant erdafitinib dose reduction or use of alternative concomitant medications with no or minimal CYP2C9 or CYP3A4 inhibition potential.
TRIAL REGISTRATION


ClinicalTrials.gov identifier number: NCT03135106.",2020,"No safety concerns were identified with single-dose erdafitinib when administered alone and in combination with fluconazole or itraconazole in healthy adults.
","['Healthy Adults', 'healthy participants', 'Healthy adults', 'eligible healthy adults', 'healthy adults']","['fluconazole (moderate CYP2C9 and CYP3A inhibitor), and itraconazole', 'itraconazole', 'Fluconazole and Itraconazole', 'fluconazole', 'fluconazole or itraconazole', 'CYP2C9 genotype to receive Treatment A (single oral dose of erdafitinib 4 mg) on day 1, Treatment B (fluconazole 400 mg/day orally) on days 1-11, or Treatment C (itraconazole']","['C max  of erdafitinib', 'pharmacokinetics and safety', 'ratio of total amount of erdafitinib excreted in the urine', 'Erdafitinib exposure', 'mean maximum plasma concentration (C max ), area under the curve (AUC) from time 0 to 168\xa0h (AUC 168h ), AUC from time 0 to the last quantifiable concentration (AUC last ), and AUC from time 0 to infinity (AUC ∞ ', 'erdafitinib C max  and increased AUC']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1828473', 'cui_str': 'Cytochrome P450 MP-8'}, {'cui': 'C3850056', 'cui_str': 'CYP3A Inhibitors'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0583919,"No safety concerns were identified with single-dose erdafitinib when administered alone and in combination with fluconazole or itraconazole in healthy adults.
","[{'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Poggesi', 'Affiliation': 'Global Clinical Pharmacology, Quantitative Sciences, Janssen-Cilag SpA, Via Michelangelo Buonarroti 23, 20093, Cologno Monzese, MI, Italy. ipoggesi@its.jnj.com.'}, {'ForeName': 'Lilian Y', 'Initials': 'LY', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, Springhouse, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hellemans', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Freya', 'Initials': 'F', 'LastName': 'Rasschaert', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Loeckie', 'Initials': 'L', 'LastName': 'de Zwart', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Snoeys', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Meulder', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Rao N V S', 'Initials': 'RNVS', 'LastName': 'Mamidi', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Ouellet', 'Affiliation': 'Janssen Research & Development, Springhouse, PA, USA.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-019-00581-9']
3251,1655315,CO2-laser vaporization of human papillomavirus (HPV)-induced abnormal cervical smears. A simple and effective solution to a recurrent clinical problem.,"Fifty women with human papillomavirus (HPV)-induced abnormal cervical smears were randomly allocated to either CO2-laser vaporization or routine control. The success rate at the 6 months check was 100% after laser treatment compared to that of 72% in the control group (p less than 0.05). Although longer follow-up is needed to fully establish the efficacy of the treatment, the method seems appropriate to this large group of women at risk of developing cervical intraepithelial neoplasia.",1991,The success rate at the 6 months check was 100% after laser treatment compared to that of 72% in the control group (p less than 0.05).,"['human papillomavirus (HPV)-induced abnormal cervical smears', 'Fifty women with human papillomavirus (HPV)-induced abnormal cervical smears']","['CO2-laser vaporization', 'CO2-laser vaporization or routine control']",['success rate'],"[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0476427', 'cui_str': 'Abnormal cervical smear (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0581699', 'cui_str': 'Vaporization'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],50.0,0.0181156,The success rate at the 6 months check was 100% after laser treatment compared to that of 72% in the control group (p less than 0.05).,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ruge', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital of Copenhagen, Hvidovre, Denmark.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Felding', 'Affiliation': ''}, {'ForeName': 'S O', 'Initials': 'SO', 'LastName': 'Skouby', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lundvall', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Hørding', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
3252,30448193,Supplemental parenteral nutrition improves immunity with unchanged carbohydrate and protein metabolism in critically ill patients: The SPN2 randomized tracer study.,"BACKGROUND & AIMS


Individualized supplemental parenteral nutrition (SPN) providing measured energy expenditure from day 4 reduced infectious complications in a previous study including 305 intensive care (ICU) patients. The study aimed at investigating the metabolic, and immune responses underlying the clinical response of the previous trial.
METHODS


Randomized controlled trial enrolling 23 critically ill patients on day 3 (D3) of admission to the ICU who were fed less than 60% of their energy target by the enteral nutrition (EN) alone: allocation to either continued EN or to SPN to a target validated by indirect calorimetry. Protein and glucose metabolism (primary endpoint) were investigated with tracer isotopes on D4 and D9. Secondary endpoints: 1) immune response, investigated in serum and in stimulated peripheral blood mononuclear cells (PMBC), by dosing a panel of cytokines (infectious complications were recorded), and 2) Muscle mass was assessed by ultrasound of the thigh.
RESULTS


Comparable at baseline, the SPN group (n = 11) received more energy (median 24.3 versus 17.8 kcal/kg/day: p < 0.001) and proteins (1.11 versus 0.69 g/kg/day: p < 0.001) than the control group during the five days' intervention, resulting in a less negative energy balance by D9 (p = 0.0027). Net protein breakdown and Glucose kinetics on D9 did not differ, within or between groups. In agreement with a decrease in infection rate, immune response in the SPN group showed decreased serum IL-6 (p = 0.024), IL-1β, IL-10 levels and TNF-α secretion by PBMC (p = 0.018) at D9. Muscle mass loss from D4 to D15 tended to be less in the SPN group (-16% versus -23%: p = 0.06). Clinical course by D28 did not differ.
CONCLUSIONS


Feeding patients to cover an individualised measured energy target with SPN from D4 to cover needs, was associated with improved immunity, less systemic inflammation and a trend to less muscle mass loss.
CLINICAL TRIAL REGISTRY


NCT02022813 at https://clinicaltrials.gov/.",2019,"(p = 0.024), IL-1β, IL-10 levels and TNF-α secretion by PBMC (p = 0.018) at D9.","['305 intensive care (ICU) patients', '23 critically ill patients on day 3 (D3) of admission to the ICU who were fed less than 60% of their energy target by the', 'critically ill patients']","['enteral nutrition (EN) alone: allocation to either continued EN or to SPN', 'Supplemental parenteral nutrition', 'Individualized supplemental parenteral nutrition (SPN']","['immune response, investigated in serum and in stimulated peripheral blood mononuclear cells (PMBC), by dosing a panel of cytokines (infectious complications were recorded), and 2) Muscle mass was assessed by ultrasound of the thigh', 'Net protein breakdown and Glucose kinetics', 'Muscle mass loss', 'negative energy balance', 'infection rate, immune response', 'IL-1β, IL-10 levels and TNF-α secretion by PBMC', 'serum IL-6', 'Protein and glucose metabolism']","[{'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0085559'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}]","[{'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",23.0,0.112555,"(p = 0.024), IL-1β, IL-10 levels and TNF-α secretion by PBMC (p = 0.018) at D9.","[{'ForeName': 'Mette M', 'Initials': 'MM', 'LastName': 'Berger', 'Affiliation': 'Service of Adult Intensive Care and Burns, Lausanne University Hospital - CHUV, Rue du Bugnon 46, Lausanne, Switzerland. Electronic address: Mette.Berger@chuv.ch.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Pantet', 'Affiliation': 'Service of Adult Intensive Care and Burns, Lausanne University Hospital - CHUV, Rue du Bugnon 46, Lausanne, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Jacquelin-Ravel', 'Affiliation': 'Service of Adult Intensive Care and Burns, Lausanne University Hospital - CHUV, Rue du Bugnon 46, Lausanne, Switzerland.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Charrière', 'Affiliation': 'Service of Adult Intensive Care and Burns, Lausanne University Hospital - CHUV, Rue du Bugnon 46, Lausanne, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Becce', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Régine', 'Initials': 'R', 'LastName': 'Audran', 'Affiliation': 'Division of Immunology and Allergy, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Spertini', 'Affiliation': 'Division of Immunology and Allergy, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Tappy', 'Affiliation': 'Department of Physiology, University of Lausanne, Rue du Bugnon 7, CH-1005, Lausanne, Switzerland.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Pichard', 'Affiliation': 'Clinical Nutrition, Geneva University Hospital, 1205 Geneva, Switzerland.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.10.023']
3253,22539562,"First-line treatment of advanced ovarian cancer with paclitaxel/carboplatin with or without epirubicin (TEC versus TC)--a gynecologic cancer intergroup study of the NSGO, EORTC GCG and NCIC CTG.","BACKGROUND


The addition of anthracyclines to platinum-based chemotherapy may provide benefit in survival in ovarian cancer patients. We evaluated the effect on survival of adding epirubicin to standard carboplatin and paclitaxel.
PATIENTS AND METHODS


We carried out a prospectively randomized phase III study comparing carboplatin plus paclitaxel (TC; area under the curve 5 and 175 mg/m(2)) with the same combination and epirubicin (TEC; 75 mg/m(2) i.v.). Between March 1999 and August 2001, 887 patients with epithelial ovarian, tubal or peritoneal cancer International Federation of Gynecology and Obstetrics stages IIB-IV were randomized to receive either TC (442 patients) or TEC (445 patients).
RESULTS


Median time to progression was 16.4 months in the TEC arm and 16.0 months in the TC arm (hazard ratio 0.99; 95% confidence interval [CI]: 0.9-1.2). Median overall survival time was 42.4 months for the TEC arm and 40.2 for the TC arm (hazard ratio 0.96; 95% CI: 0.8-1.1). Grade 3/4 hematologic toxic effects and most grade 3/4 non-hematologic toxic effects were more frequent in the TEC arm. Accordingly, a quality-of-life analysis showed inferiority of TEC versus TC.
CONCLUSION


The addition of epirubicin to standard carboplatin and paclitaxel treatment did not improve survival in patients with advanced ovarian, tubal or peritoneal cancer.",2012,"RESULTS


Median time to progression was 16.4 months in the TEC arm and 16.0 months in the TC arm (hazard ratio 0.99; 95% confidence interval [CI]: 0.9-1.2).","['Between March 1999 and August 2001, 887 patients with epithelial ovarian, tubal or peritoneal cancer International Federation of Gynecology and Obstetrics stages IIB-IV', 'patients with advanced ovarian, tubal or peritoneal cancer', '445 patients', 'advanced ovarian cancer with', 'ovarian cancer patients']","['paclitaxel/carboplatin with or without epirubicin (TEC', 'epirubicin (TEC', 'anthracyclines to platinum-based chemotherapy', 'carboplatin plus paclitaxel (TC', 'epirubicin to standard carboplatin and paclitaxel', 'TEC', 'TC']","['survival', 'Median overall survival time', 'Median time to progression', 'Grade 3/4 hematologic toxic effects and most grade 3/4 non-hematologic toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",887.0,0.175548,"RESULTS


Median time to progression was 16.4 months in the TEC arm and 16.0 months in the TC arm (hazard ratio 0.99; 95% confidence interval [CI]: 0.9-1.2).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lindemann', 'Affiliation': 'Department of Gynecological Cancer, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Christensen', 'Affiliation': 'Department of Medical Statistics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Stuart', 'Affiliation': 'Department of Gynecologic Oncology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Izquierdo', 'Affiliation': 'Institute of Oncology, Catalán Hospital, Catalania, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kærn', 'Affiliation': 'Department of Gynecological Cancer, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Havsteen', 'Affiliation': 'Department of Oncology, Herlev University Hospital, Herlev, Denmark.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Eisenhauer', 'Affiliation': ""Department of Oncology, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ridderheim', 'Affiliation': 'Department of Gynecologic Oncology, Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Lopez', 'Affiliation': 'Department of Gynecologic Oncology, Queen Elizabeth Hospital, Gateshead, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hirte', 'Affiliation': 'Department of Oncology, Division of Medical Oncology, Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Aavall-Lundquvist', 'Affiliation': 'Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vrdoljak', 'Affiliation': 'Department of Oncology, University Hospital, Split, Croatia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Department of Oncology, Clatterbridge Hospital, Wirral, UK.'}, {'ForeName': 'G B', 'Initials': 'GB', 'LastName': 'Kristensen', 'Affiliation': 'Department of Gynecological Cancer, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Department of Gynecological Cancer, Institute for Medical Informatics, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway. Electronic address: gunnar.b.kristensen@gmail.com.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds060']
3254,31813404,The Effect of Operator Position on the Quality of Chest Compressions Delivered in a Simulated Ambulance.,"BACKGROUND


Ambulances are where patient care is often initiated or maintained, but this setting poses safety risks for paramedics. Paramedics have found that in order to optimize patient care, they must compromise their own safety by standing unsecured in a moving ambulance.
HYPOTHESIS/PROBLEM


This study sought to compare the quality of chest compressions in the two positions they can be delivered within an ambulance.
METHODS


A randomized, counterbalanced study was carried out with 24 paramedic students. Simulated chest compressions were performed in a stationary ambulance on a cardiopulmonary resuscitation (CPR) manikin for two minutes from either: (A) an unsecured standing position, or (B) a seated secured position. Participants' attitudes toward the effectiveness of the two positions were evaluated.
RESULTS


The mean total number of chest compressions was not significantly different standing unsecured (220; SD = 12) as compared to seated and secured (224; SD = 21). There was no significant difference in mean compression rate standing unsecured (110 compressions per minute; SD = 6) as compared to seated and secured (113 compressions per minute; SD = 10). Chest compressions performed in the unsecured standing position yielded a significantly greater mean depth (52 mm; SD = 6) than did seated secured (26 mm; SD = 7; P < .001). Additionally, the standing unsecured position produced a significantly higher percentage (83%; SD = 21) for the number of correct compressions, as compared to the seated secured position (8%; SD = 17; P < .001). Participants also believed that chest compressions delivered when standing were more effective than those delivered when seated.
CONCLUSIONS


The quality of chest compressions delivered from a seated and secured position is inferior to those delivered from an unsecured standing position. There is a need to consider how training, technologies, and ambulance design can impact the quality of chest compressions.",2020,There was no significant difference in mean compression rate standing unsecured (110 compressions per minute; SD = 6) as compared to seated and secured (113 compressions per minute; SD = 10).,['24 paramedic students'],"['cardiopulmonary resuscitation (CPR) manikin for two minutes from either: (A) an unsecured standing position, or (B) a seated secured position', 'Operator Position']","['mean compression rate standing', 'mean total number of chest compressions', 'Quality of Chest Compressions', 'mean depth', 'quality of chest compressions']","[{'cui': 'C0030450', 'cui_str': 'Paramedics'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]",,0.031034,There was no significant difference in mean compression rate standing unsecured (110 compressions per minute; SD = 6) as compared to seated and secured (113 compressions per minute; SD = 10).,"[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Mullin', 'Affiliation': 'Department of Science and Health, Medicine Hat College, Medicine Hat, Alberta, Canada.'}, {'ForeName': 'Sinéad', 'Initials': 'S', 'LastName': 'Lydon', 'Affiliation': 'Irish Centre for Applied Patient Safety and Simulation, National University of Ireland Galway, Co. Galway, Ireland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': ""O'Connor"", 'Affiliation': 'Irish Centre for Applied Patient Safety and Simulation, National University of Ireland Galway, Co. Galway, Ireland.'}]",Prehospital and disaster medicine,['10.1017/S1049023X19005193']
3255,32016500,Impact of Dorsal Preservation Rhinoplasty Versus Dorsal Hump Resection on the Internal Nasal Valve: a Quantitative Radiological Study.,"BACKGROUND


This study evaluates the impact of different hump takedown techniques, namely the conventional hump resection with midvault reconstruction, the push-down (PD) and the let-down (LD) procedures, on the INV dimensions.
METHODS


In this cadaveric study, six heads were divided randomly into either the conventional hump resection technique (Group A; n = 6 sides) or DPR techniques (n = 6 sides). This latter group was subdivided such that initially a PD procedure was performed (Group B; n = 6 sides), followed by a LD procedure on the same heads (Group C; n = 6 sides). A validated radiological method was used to measure the INV angle and cross-sectional area (CSA) in a modified coronal plane both pre- and post-procedurally.
RESULTS


Group A did not show significant reduction in the INV angle nor in CSA (p = 0.068 and p = 0.156, respectively). In the push-down group (B), we observed a mean change of 2.05° in the angles and 0.3 cm 2  in the CSA (p = 0.0163 and p < 0.001, respectively). The LD group (C) did not show significant reduction in the INV angle nor in CSA (p = 0.437 and p = 0.331, respectively).
CONCLUSION


Neither the conventional hump resection nor the LD DPR technique reduced the INV dimensions. However, the PD preservation technique significantly reduced the INV dimensions.
LEVEL OF EVIDENCE III


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2020,"RESULTS


Group A did not show significant reduction in the INV angle nor in CSA (p = 0.068 and p = 0.156, respectively).",[],"['conventional hump resection technique (Group A; n\u2009=\u20096 sides) or DPR techniques', 'Dorsal Preservation Rhinoplasty', 'conventional hump resection with midvault reconstruction, the push-down (PD) and the let-down (LD) procedures', 'Dorsal Hump Resection']","['INV angle nor in CSA', 'INV angle and cross-sectional area (CSA', 'INV dimensions']",[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441987', 'cui_str': 'Side (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C1719958', 'cui_str': 'Push'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}]",6.0,0.0172006,"RESULTS


Group A did not show significant reduction in the INV angle nor in CSA (p = 0.068 and p = 0.156, respectively).","[{'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Abdelwahab', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head & Neck Surgery, Stanford University School of Medicine, 801 Welch Road, Stanford, CA, 94305, USA.'}, {'ForeName': 'Caio A', 'Initials': 'CA', 'LastName': 'Neves', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head & Neck Surgery, Stanford University School of Medicine, 801 Welch Road, Stanford, CA, 94305, USA.'}, {'ForeName': 'Priyesh N', 'Initials': 'PN', 'LastName': 'Patel', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head & Neck Surgery, Stanford University School of Medicine, 801 Welch Road, Stanford, CA, 94305, USA.'}, {'ForeName': 'Sam P', 'Initials': 'SP', 'LastName': 'Most', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head & Neck Surgery, Stanford University School of Medicine, 801 Welch Road, Stanford, CA, 94305, USA. smost@stanford.edu.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01627-z']
3256,31792947,GP-Led Deprescribing in Community-Living Older Australians: An Exploratory Controlled Trial.,"OBJECTIVE


To assess feasibility, effectiveness, and safety of a multifaceted general practitioner (GP) led intervention to reduce potentially inappropriate polypharmacy in community-living older people.
DESIGN


Pragmatic, controlled, pre-post design.
SETTING


Five general practices in southeast Queensland, Australia.
PARTICIPANTS


Ten GPs from three practices, two pharmacists, and 78 patients comprised the intervention group, and 10 GPs from two practices and 67 patients comprised the usual care group. Patients were aged 65 years or older, receiving five or more regularly prescribed medicines, and capable of participating in telephone interviews in English.
INTERVENTION


A 5-hour interactive deprescribing training workshop for clinicians; an extended deprescribing consultation between GPs and enrolled patients, entailing a comprehensive review of their medicines using a standardized software template codesigned by GPs; and comprehensive medicine review by a pharmacist, at the GP's discretion.
OUTCOME MEASURES


Primary outcome was mean difference in number of regular medicines deprescribed (ie, ceased or dose reduced) per patient over an 18-week follow-up period. Medicine-specific and patient-reported outcomes, safety, and process measures were also evaluated.
RESULTS


At study completion, mean (SD) number of regular medicines deprescribed per patient was 0.99 (1.23) in the intervention group vs 0.43 (0.84) in the usual care group, equaling a mean difference of 0.55 (95% confidence interval = -0.90 to -0.21; P = .002). Crude totals showed 77 of 649 (11.9%) vs 29 of 571 (5.1%) regular medicines deprescribed in intervention and usual care groups, respectively (P < .001). Supplements, gastric acid suppressants, statins, oral hypoglycemics, and diuretics were medicine classes more frequently deprescribed. There were no statistically significant between-group differences in numbers of medicines commenced, self-reported unplanned hospitalizations, or worsened health-related quality of life. A subset of intervention patients reported greater certainty in the necessity and appropriateness of their medicines at study end.
CONCLUSION


The deprescribing intervention appears feasible, was modestly effective, and was not associated with any major safety events. J Am Geriatr Soc 68:403-410, 2020.",2020,"There were no statistically significant between-group differences in numbers of medicines commenced, self-reported unplanned hospitalizations, or worsened health-related quality of life.","['community-living older people', 'Ten GPs from three practices, two pharmacists, and 78 patients comprised the intervention group, and 10 GPs from two practices and 67 patients comprised the usual care group', 'Five general practices in southeast Queensland, Australia', 'Community-Living Older Australians', 'Patients were aged 65\u2009years or older, receiving five or more regularly prescribed medicines, and capable of participating in telephone interviews in English']","['GP-Led Deprescribing', 'multifaceted general practitioner (GP) led intervention']","['mean (SD) number of regular medicines', 'numbers of medicines commenced, self-reported unplanned hospitalizations, or worsened health-related quality of life', 'mean difference in number of regular medicines deprescribed (ie, ceased or dose reduced) per patient']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",5.0,0.211871,"There were no statistically significant between-group differences in numbers of medicines commenced, self-reported unplanned hospitalizations, or worsened health-related quality of life.","[{'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Centre of Research Excellence in Quality and Safety in Integrated Primary-Secondary Care, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Freeman', 'Affiliation': 'School of Pharmacy, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Foster', 'Affiliation': 'Centre of Research Excellence in Quality and Safety in Integrated Primary-Secondary Care, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Scott', 'Affiliation': 'Centre of Research Excellence in Quality and Safety in Integrated Primary-Secondary Care, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16273']
3257,1294345,"Bromocriptine (Bromergon, Lek) in the management of premenstrual syndrome.","The efficacy of bromocriptine (Bromergon, Lek) was studied in a group of 21 women with premenstrual syndrome (PMS). To qualify for inclusion, the patients had to have a score of 20 or more on Casper's Analog Self-Rating Scale for Premenstrual Tension Syndrome completed during the last premenstrual week. The study was designed as a double-blind, randomized, cross-over trial introduced by a wash-out cycle. Patients received Bromergon in a daily dose of 5 mg from cycle day 10 to the onset of menstruation for two consecutive menstrual cycles, followed by two placebo cycles or vice versa. The subjects were instructed to complete the scale every three days from cycle day 3 to the onset of menstruation. A statistically significant improvement due to the administration of Bromergon was observed in symptoms associated with overreactiveness to normal prolactin levels, i.e. abdominal tension, edema, weight gain and breast tenderness. Scores on the linear analog scale and physician's assessments differed regarding psychological symptoms. The investigators observed no difference in the presence of psychic symptoms in the treatment-free period, on Bromergon therapy and during the administration of placebo. On the other hand, self-rating scores reflected an improvement in the presence of depression and irritability during Bromergon treatment. The results obtained suggest that Bromergon may be a useful agent for the treatment of somatic symptoms associated with PMS, while it seems somewhat less effective in PMS cases where psychic symptoms are the major complaint.",1992,"A statistically significant improvement due to the administration of Bromergon was observed in symptoms associated with overreactiveness to normal prolactin levels, i.e. abdominal tension, edema, weight gain and breast tenderness.","[""patients had to have a score of 20 or more on Casper's Analog Self-Rating Scale for Premenstrual Tension Syndrome completed during the last premenstrual week"", '21 women with premenstrual syndrome (PMS']","['Bromocriptine (Bromergon, Lek', 'placebo cycles or vice versa', 'bromocriptine (Bromergon, Lek', 'placebo']","['depression and irritability', 'normal prolactin levels, i.e. abdominal tension, edema, weight gain and breast tenderness', 'psychic symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0222045'}, {'cui': 'C0376356', 'cui_str': 'Premenstrual Tension'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0443282', 'cui_str': 'Premenstrual (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}]","[{'cui': 'C0006230', 'cui_str': 'Bromocriptine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0262397', 'cui_str': 'Breast tenderness (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",21.0,0.0554522,"A statistically significant improvement due to the administration of Bromergon was observed in symptoms associated with overreactiveness to normal prolactin levels, i.e. abdominal tension, edema, weight gain and breast tenderness.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Meden-Vrtovec', 'Affiliation': 'Department of Gynecology, University Hospital Center, Ljubljana, Slovenia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vujić', 'Affiliation': ''}]",Clinical and experimental obstetrics & gynecology,[]
3258,32006073,Endoscopic fasciotomy for plantar fasciitis provides superior results when compared to a controlled non-operative treatment protocol: a randomized controlled trial.,"PURPOSE


Plantar fasciitis is a frequent and painful condition with a lifetime incidence of 10%. Good results have been reported for operative treatment of plantar fasciitis refractory to non-surgical interventions in uncontrolled studies. The aim of this study was to compare the results of operative treatment (endoscopic debridement, removal of the heel spur and partial resection of the plantar fascia) with those of a controlled and supervised non-operative rehabilitation program.
METHODS


Thirty consecutive patients with plantar fasciitis during more than 3 months were randomized to either (1) non-operative treatment with corticosteroid injections and a controlled strength training program or (2) an endoscopic 2-incision operation with partial fasciotomy and heel spur removal followed by the same strength training program. Patients were evaluated at entry and 3, 6, 12 and 24 months post-operatively with the foot function index (FFI) and pain score during activity on a 100 mm VAS scale (VAS activity). FFI at 6 and 12 months was defined a priori as primary endpoint.
RESULTS


Both groups improved significantly over time. The FFI score was significantly better in the operated group compared to the non-surgically treated group 12 months post-operatively (p = 0.033), at 24 months this was, however, not significant (p = 0.06). VAS activity at 24 months was significantly (p = 0.001) in favor of the operative group. More patients returned to running and jumping in the operative group (p = 0.04).
CONCLUSION


This randomized controlled trial found significant and clinically relevant superior results for the operative treatment of plantar fasciitis as measured by Foot Function Index at 1 year and by VAS activity at 2-year follow-up when compared to the results of a supervised rehabilitation program.
LEVEL OF EVIDENCE


I.",2020,"The FFI score was significantly better in the operated group compared to the non-surgically treated group 12 months post-operatively (p = 0.033), at 24 months this was, however, not significant (p = 0.06).",['Thirty consecutive patients with plantar fasciitis during more than 3\xa0months'],"['operative treatment (endoscopic debridement, removal of the heel spur and partial resection of the plantar fascia', 'corticosteroid injections and a controlled strength training program or (2) an endoscopic 2-incision operation with partial fasciotomy and heel spur removal followed by the same strength training program', 'Endoscopic fasciotomy']","['VAS activity', 'FFI score', 'foot function index (FFI) and pain score during activity on a 100\xa0mm VAS scale (VAS activity', 'Foot Function Index at 1\xa0year and by VAS activity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0158322', 'cui_str': 'Calcaneal Spur'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0185188', 'cui_str': 'Fasciectomy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index (assessment scale)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",30.0,0.0254892,"The FFI score was significantly better in the operated group compared to the non-surgically treated group 12 months post-operatively (p = 0.033), at 24 months this was, however, not significant (p = 0.06).","[{'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Johannsen', 'Affiliation': 'Institute of Sports Medicine, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Konradsen', 'Affiliation': 'Section for Sports Traumatology M51, Department of Orthopedic Surgery, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400, Copenhagen, Denmark. Lars.Konradsen@RegionH.dk.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Herzog', 'Affiliation': 'Department of Physiotherapy, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Michael Rindom', 'Initials': 'MR', 'LastName': 'Krogsgaard', 'Affiliation': 'Section for Sports Traumatology M51, Department of Orthopedic Surgery, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400, Copenhagen, Denmark.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-05855-3']
3259,31935529,Cognitive behavior therapy in early psychosis with a focus on depression and low self-esteem: A randomized controlled trial.,"BACKGROUND


Patients in early phases of psychosis often struggle with depressive symptoms and low self-esteem. The main aims of the present study were to examine whether cognitive behavior therapy (CBT) compared to treatment as usual (TAU) would reduce depressive symptoms (primary outcome) and increase self-esteem (secondary outcome). Furthermore, we wanted to examine whether CBT reduces symptoms measured with the PANSS (positive, negative, cognitive, or excited symptoms) or increases general functioning compared to TAU.
METHODS


A total of 63 early psychosis patients were included and randomly assigned to receive either CBT (maximum 26 sessions) or TAU for a period of up to six months. A linear mixed model was used for longitudinal analysis, with a focus on whether patients in the CBT group or the TAU group changed differently to one another between the baseline and 15-month follow-up.
RESULTS


There were no differences between the CBT group and TAU group regarding improvements in depressive symptoms measured with the Calgary Depression Scale for Schizophrenia (P = 0.188) or self-esteem measured with the Rosenberg Self-Esteem Scale (P = 0.580). However, patients in the CBT group improved significantly more on negative symptoms (P = 0.002) and social functioning (P = 0.001).
CONCLUSIONS


We did not find CBT to be more effective than TAU in reducing depressive symptoms or increasing self-esteem in patients with early psychosis. However, CBT seems to improve negative symptoms and functioning. These results still need to be replicated in further studies as the present one was merely an exploratory analysis. ClinicalTrials.gov Identifier: NCT01511406.",2020,There were no differences between the CBT group and TAU group regarding improvements in depressive symptoms measured with the Calgary Depression Scale for Schizophrenia (P = 0.188) or self-esteem measured with the Rosenberg Self-Esteem Scale (P = 0.580).,"['63 early psychosis patients', 'Patients in early phases of psychosis often struggle with depressive symptoms and low self-esteem', 'patients with early psychosis', 'early psychosis with a focus on depression and low self-esteem']","['TAU', 'cognitive behavior therapy (CBT', 'CBT', 'Cognitive behavior therapy', 'CBT (maximum 26 sessions) or TAU']","['Calgary Depression Scale for Schizophrenia', 'social functioning', 'depressive symptoms', 'Rosenberg Self-Esteem Scale', 'self-esteem', 'negative symptoms']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem (finding)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale (assessment scale)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",63.0,0.163251,There were no differences between the CBT group and TAU group regarding improvements in depressive symptoms measured with the Calgary Depression Scale for Schizophrenia (P = 0.188) or self-esteem measured with the Rosenberg Self-Esteem Scale (P = 0.580).,"[{'ForeName': 'Nasrettin', 'Initials': 'N', 'LastName': 'Sönmez', 'Affiliation': 'Diakonhjemmet Hospital, Forskningsveien 7, 0373 Oslo, Norway; Department of Research and Education, Clinic of Mental Health and Addiction, Oslo University Hospital, Norway.'}, {'ForeName': 'Kristin Lie', 'Initials': 'KL', 'LastName': 'Romm', 'Affiliation': 'Department of Research and Education, Clinic of Mental Health and Addiction, Oslo University Hospital, Norway; NORMENT, KG Jebsen Centre for Psychosis Research, Institute of Clinical Medicine, University of Oslo, 0424 Oslo, Norway.'}, {'ForeName': 'Tiril', 'Initials': 'T', 'LastName': 'Østefjells', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Institute of Clinical Medicine, University of Oslo, 0424 Oslo, Norway; Department for Specialised Inpatient Treatment, Akershus University Hospital, Sykehusveien 25, 1478 Lørenskog, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Grande', 'Affiliation': 'Grande, Sandviksveien 157, 1337 Sandvika, Norway.'}, {'ForeName': 'Lene Hunnicke', 'Initials': 'LH', 'LastName': 'Jensen', 'Affiliation': 'Early Intervention in Psychosis Unit, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hummelen', 'Affiliation': 'Department of Research and Education, Clinic of Mental Health and Addiction, Oslo University Hospital, Norway.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tesli', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Institute of Clinical Medicine, University of Oslo, 0424 Oslo, Norway; Department of Mental Disorders, Norwegian Institute of Public Health, P.O. Box 4404, Nydalen, 0403 Oslo, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Melle', 'Affiliation': 'Department of Research and Education, Clinic of Mental Health and Addiction, Oslo University Hospital, Norway; NORMENT, KG Jebsen Centre for Psychosis Research, Institute of Clinical Medicine, University of Oslo, 0424 Oslo, Norway.'}, {'ForeName': 'Jan Ivar', 'Initials': 'JI', 'LastName': 'Røssberg', 'Affiliation': 'Department of Research and Education, Clinic of Mental Health and Addiction, Oslo University Hospital, Norway; NORMENT, KG Jebsen Centre for Psychosis Research, Institute of Clinical Medicine, University of Oslo, 0424 Oslo, Norway. Electronic address: j.i.rossberg@medisin.uio.no.'}]",Comprehensive psychiatry,['10.1016/j.comppsych.2019.152157']
3260,30466622,Effect of Artemisia annua and Artemisia afra tea infusions on schistosomiasis in a large clinical trial.,"BACKGROUND AND OBJECTIVE


Schistosomiasis (bilharzia), a serious neglected tropical disease affecting millions, has few cost-effective treatments, so two Artemisia wormwood species, A. annua and A. afra, were compared with the current standard praziquantel (PZQ) treatment in an 800 patient clinical trial, August-November of 2015.
METHODS


The double blind, randomized, superiority clinical trial had three treatment arms: 400 for PZQ, 200 for A. annua, and 200 for A. afra. PZQ-treated patients followed manufacturer posology. Artemisia-treated patients received 1 l/d of dry leaf/twig tea infusions divided into 3 aliquots daily, for 7 days with 28-day follow-up.
RESULTS


Of 800 enrolled patients having an average of >700 Schistosoma mansoni eggs per fecal sample, 780 completed the trial. Within 14 days of treatment, all Artemisia-treated patients had no detectable eggs in fecal smears, a result sustained 28 days post treatment. Eggs in fecal smears of PZQ-treated patients were undetectable after D21. More males than females who entered the trial had melena, but both genders responded equally well to treatment; by D28 melena disappeared in all patients. In all arms, eosinophil levels declined by about 27% from D0 to D28. From D0 to D28 hemoglobin increases were greater in PZQ and A. afra-treated patients than in A. annua-treated patients. Hematocrit increases were greater from D0 to D28 for patients treated with either PZQ or A. annua compared to those treated with A. afra. Gender comparison showed that A. afra-treated males had significantly greater hemoglobin and hematocrit increases by D28 than either PZQ or A. annua-treated males. In contrast, PZQ and A. afra-treated females had greater hemoglobin and hematocrit increases than A. annua-treated females. Both adults and pediatric patients treated with A. annua responded better compared to PZQ treatment.
CONCLUSION


Both A. annua and A. afra provided faster effective treatment of schistosomiasis and should be considered for implementation on a global scale.",2018,Hematocrit increases were greater from D0 to D28 for patients treated with either PZQ or A. annua compared to those treated with A. afra.,"['800 enrolled patients having an average of >700 Schistosoma mansoni eggs per fecal sample, 780 completed the trial', '800 patient clinical trial, August-November of 2015', ' 400 for PZQ, 200 for A. annua, and 200 for A. afra']","['praziquantel (PZQ', 'PZQ', 'Artemisia annua and Artemisia afra tea infusions', 'PZQ-treated patients followed manufacturer posology']","['Hematocrit increases', 'eosinophil levels', 'fecal smears', 'hemoglobin and hematocrit']","[{'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C4038804', 'cui_str': 'Schistosoma mansoni ovum'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0686899', 'cui_str': 'Sweet Annie'}, {'cui': 'C0331308', 'cui_str': 'Sagebrush'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0239935', 'cui_str': 'Hematocrit high'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0475363', 'cui_str': 'Fecal smear (specimen)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}]",800.0,0.102374,Hematocrit increases were greater from D0 to D28 for patients treated with either PZQ or A. annua compared to those treated with A. afra.,"[{'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Munyangi', 'Affiliation': 'Faculté de Médecine Université de Kolwesi/Lualaba, Democratic Republic of the Congo.'}, {'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Cornet-Vernet', 'Affiliation': ""Vice Présidente de La Maison de l'Artemisia(association Loi 1901), 20 rue Pierre Demours, 75017Paris, France. Electronic address: lcv@maison-artemisia.org.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Idumbo', 'Affiliation': 'Centre de Santé de Lubile, Maniema, Democratic Republic of the Congo.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Mathematics, Worcester Polytechnic Institute, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Lutgen', 'Affiliation': 'Association IFVB-BELHERB, Luxembourg.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Perronne', 'Affiliation': 'Faculté de Médecine de Paris IDF Ouest, France.'}, {'ForeName': 'Nadège', 'Initials': 'N', 'LastName': 'Ngombe', 'Affiliation': 'Faculté de Pharmacie, Université de Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Bianga', 'Affiliation': 'Programme National Lutte Contre le Paludisme, Maniema, Democratic Republic of the Congo.'}, {'ForeName': 'Bavon', 'Initials': 'B', 'LastName': 'Mupenda', 'Affiliation': 'Ecole de Santé Publique Université de Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lalukala', 'Affiliation': 'Ministère Provincial de Santé Publique Maniema, Democratic Republic of the Congo.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Mergeai', 'Affiliation': 'Université de Liège, Belgium.'}, {'ForeName': 'Dieudonné', 'Initials': 'D', 'LastName': 'Mumba', 'Affiliation': 'Faculté de Médecine Université de Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Towler', 'Affiliation': 'Department of Biology and Biotechnology, Worcester Polytechnic Institute, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Weathers', 'Affiliation': 'Department of Biology and Biotechnology, Worcester Polytechnic Institute, USA.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2018.10.014']
3261,31346621,Safety and Effectiveness of VYC-17.5L for Long-Term Correction of Nasolabial Folds.,"BACKGROUND


Juvéderm Vollure XC (VYC-17.5L; Allergan plc, Dublin, Ireland) belongs to a family of hyaluronic acid gels based on the Vycross technology platform.
OBJECTIVES


The authors sought to evaluate the safety and effectiveness of Vollure for correction of moderate to severe nasolabial folds (NLFs) over 18 months and after repeat treatment.
METHODS


In this prospective, randomized study, patients (N = 123) received initial/touch-up treatment with Vollure in 1 NLF and control filler in the contralateral NLF. Patients received optional repeat treatment with Vollure after month 12, 15, or 18. Assessments included investigator-rated NLF Severity Scale responder rates (≥1-point improvement vs baseline), patient-assessed Appraisal of Nasolabial Folds scale of the FACE-Q questionnaire, and patient satisfaction (11-point scale).
RESULTS


Median volume of Vollure injected was 1.7 mL for initial/touch-up treatment combined and 0.6 mL for repeat treatment. The NLF Severity Scale responder rates were 93%, 85%, and 59% at months 6, 9, and 18 after initial/touch-up treatment and increased to 94% at 1 month after repeat treatment. Mean patient-reported FACE-Q scores significantly improved from baseline at all timepoints. Most patients were very satisfied with treatment at all timepoints from day 3 (75%) through month 18 (68%) and at 1 month after repeat treatment (94%). Common injection site responses after initial/touch-up and repeat treatment were firmness, swelling, and tenderness to touch; most were mild/moderate.
CONCLUSIONS


Vollure was safe and effective for correction of moderate to severe NLFs, with results lasting 18 months in 59% of NLFs. Repeat treatment required one-third of the injection volume to achieve similar improvement in NLF severity as initial/touch-up treatment.
LEVEL OF EVIDENCE: 2


",2020,Most subjects were very satisfied with treatment at all timepoints from day 3 (75%) through month 18 (68%) and at 1 month after repeat treatment (94%).,['subjects (N=123) received'],"['initial/touch-up treatment with Vollure in 1 NLF and control filler in the contralateral NLF', 'VYC-17.5L']","['Safety and Effectiveness', 'NLFSS responder rate', 'Mean subject-reported FACE-Q scores', 'investigator-rated NLF Severity Scale (NLFSS) responder rates (≥1-point improvement vs baseline); subject-assessed Appraisal of Nasolabial Folds scale of the FACE-Q questionnaire; and subject satisfaction (11-point scale', 'NLF severity']",[],"[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial Fold'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0199834,Most subjects were very satisfied with treatment at all timepoints from day 3 (75%) through month 18 (68%) and at 1 month after repeat treatment (94%).,"[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Dayan', 'Affiliation': ''}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Maas', 'Affiliation': ''}, {'ForeName': 'Pearl E', 'Initials': 'PE', 'LastName': 'Grimes', 'Affiliation': ''}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Beer', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Monheit', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Snow', 'Affiliation': ''}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Lin', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjz200']
3262,31595565,Influence of methazolamide on the human control of breathing: A comparison to acetazolamide.,"NEW FINDINGS


What is the central question of this study? Acetazolamide and methazolamide both reduce hypoxic pulmonary vasoconstriction equally, but methazolamide does not impair skeletal muscle function. The effect of methazolamide on respiratory control in humans is not yet known. What is the main finding and its importance? Similar to acetazolamide after chronic oral administration, methazolamide causes a metabolic acidosis and shifts the ventilatory CO 2  response curve leftwards without reducing O 2  sensitivity. The change in ventilation over the change in log  P   O   2      provides a more accurate measure of hypoxic sensitivity than the change in ventilation over the change in arterial oxyhaemoglobin saturation.
ABSTRACT


Acetazolamide is used to prevent/treat acute mountain sickness and both central and obstructive sleep apnoea. Methazolamide, like acetazolamide, reduces hypoxic pulmonary vasoconstriction, but has fewer side-effects, including less impairment of skeletal muscle function. Given that the effects of methazolamide on respiratory control in humans are unknown, we compared the effects of oral methazolamide and acetazolamide on ventilatory control and determined the ventilation-log   P   O   2      relationship in humans. In a double-blind, placebo-controlled, randomized cross-over design, we studied the effects of acetazolamide (250 mg three times daily), methazolamide (100 mg twice daily) and placebo in 14 young male subjects who were exposed to 7 min of normoxic hypercapnia and to three levels of eucapnia and hypercapnic hypoxia. With placebo, methazolamide and acetazolamide, the CO 2  sensitivities were 2.39 ± 1.29, 3.27 ± 1.82 and 2.62 ± 1.79 l min -1   mmHg -1  (n.s.) and estimated apnoeic thresholds 32 ± 3, 28 ± 3 and 26 ± 3 mmHg, respectively (P < 0.001, placebo versus methazolamide and acetazolamide). The relationship between ventilation (    V   ̇   I    ) and log   P   O   2      (using arterialized venous  P   O   2      in hypoxia) was linear, and neither agent influenced the relationship between hypoxic sensitivity (  Δ   V   ̇   I   /   Δ   log   P   O   2        ) and arterial [H +  ]. Using  Δ   V   ̇   I   /   Δ   log   P   O   2        rather than Δ    V   ̇   I    /Δ arterial oxyhaemoglobin saturation enables a more accurate estimation of oxygenation and ventilatory control in metabolic acidosis/alkalosis when right- or leftward shifts of the oxyhaemoglobin saturation curve occur. Given that acetazolamide and methazolamide have similar effects on ventilatory control, methazolamide might be preferred for indications requiring the use of a carbonic anhydrase inhibitor, avoiding some of the negative side-effects of acetazolamide.",2020,"Methazolamide, like acetazolamide reduces hypoxic pulmonary vasoconstriction, but has fewer side effects including less skeletal muscle function impairment.",['fourteen young male subjects who were exposed to 7 minutes of normoxic hypercapnia and to three levels of eucapnia and hypercapnic hypoxia'],"['acetazolamide', 'methazolamide', 'I  /ΔSaO', 'placebo, methazolamide, and acetazolamide', 'placebo', 'Acetazolamide and methazolamide', 'Acetazolamide', 'Methazolamide, like acetazolamide', 'methazolamide and acetazolamide', 'acetazolamide and methazolamide']",['hypoxic sensitivity'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0025631', 'cui_str': 'Methazolamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",,0.0562354,"Methazolamide, like acetazolamide reduces hypoxic pulmonary vasoconstriction, but has fewer side effects including less skeletal muscle function impairment.","[{'ForeName': 'Luc J', 'Initials': 'LJ', 'LastName': 'Teppema', 'Affiliation': 'Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Boulet', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Hackett', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Paolo B', 'Initials': 'PB', 'LastName': 'Dominelli', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Cheyne', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Giulio S', 'Initials': 'GS', 'LastName': 'Dominelli', 'Affiliation': 'Southern Medical Program, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Erik R', 'Initials': 'ER', 'LastName': 'Swenson', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, VA Puget Sound Health Care System, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Glen E', 'Initials': 'GE', 'LastName': 'Foster', 'Affiliation': 'Centre for Heart, Lung, and Vascular Health, School of Health and Exercise Science, University of British Columbia, Kelowna, BC, Canada.'}]",Experimental physiology,['10.1113/EP088058']
3263,31964381,"Intrafractional vaginal dilation in anal cancer patients undergoing pelvic radiotherapy (DILANA) - a prospective, randomized, 2-armed phase-II-trial.","BACKGROUND


The incidence of anal cancer is rising in the last decades and more women are affected than men. The prognosis after chemoradiation is very good with complete remission rates of 80-90%. Thus, reducing therapy-related toxicities and improving quality of life are of high importance. With the development of new radiotherapy techniques like IMRT (Intensity-modulated radiotherapy), the incidence of acute and chronic gastrointestinal toxicities has already been reduced. However, especially in female anal cancer patients genital toxicities like vaginal fibrosis and stenosis are of great relevance, too. Up to now, there are no prospective data reporting incidence rates, techniques of prevention or impact on quality of life. The aim of the DILANA trial is to evaluate the incidence and grade of vaginal fibrosis, to optimize radiotherapy by reducing dose to the vaginal wall to minimize genital toxicities and improve quality of life of anal cancer patients.
METHODS


The study is designed as a prospective, randomized, two-armed, open, single-center phase-II-trial. Sixty patients will be randomized into one of two arms, which differ only in the diameter of a tampon used during treatment. All patients will receive standard (chemo) radiation with a total dose of 45-50.4 Gy to the pelvic and inguinal nodes with a boost to the anal canal up to 54-60 Gy. The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12 months after (chemo) radiation depending on the extent of vaginal dilation. Secondary endpoints are toxicities according to the CTC AE version 5.0 criteria, assessment of clinical feasibility of daily use of a tampon, assessment of compliance for the use of a vaginal dilator and quality of life.
DISCUSSION


Prospective studies are needed evaluating the incidence and grade of vaginal fibrosis after (chemo) radiation in female anal cancer patients. Furthermore, the assessment of techniques to reduce the incidence of vaginal fibrosis like intrafractional vaginal dilation as well as other radiotherapy-independent methods like using a vaginal dilator are essential. Additionally, implementation of a systematic assessment of vaginal stenosis is necessary to grant reproducibility and comparability of future data.
TRIAL REGISTRATION


The trial is registered with clinicaltrials.gov (NCT04094454, 19.09.2019).",2020,"With the development of new radiotherapy techniques like IMRT (Intensity-modulated radiotherapy), the incidence of acute and chronic gastrointestinal toxicities has already been reduced.","['female anal cancer patients genital toxicities like vaginal fibrosis and stenosis', 'Sixty patients', 'female anal cancer patients', 'anal cancer patients', 'anal cancer patients undergoing']","['Intrafractional vaginal dilation', 'pelvic radiotherapy (DILANA', 'standard (chemo) radiation with a total dose of 45-50.4\u2009Gy to the pelvic and inguinal nodes with a boost to the anal canal up to 54-60\u2009Gy', 'new radiotherapy techniques like IMRT (Intensity-modulated radiotherapy']","['quality of life', 'complete remission rates', 'toxicities according to the CTC AE version 5.0 criteria, assessment of clinical feasibility of daily use of a tampon, assessment of compliance for the use of a vaginal dilator and quality of life']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0279637', 'cui_str': 'Anal Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0227411', 'cui_str': 'Anal canal structure'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}]","[{'cui': 'C0034380'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1704612', 'cui_str': 'Tampon (basic dose form)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0180446', 'cui_str': 'Vaginal dilator'}]",60.0,0.0580763,"With the development of new radiotherapy techniques like IMRT (Intensity-modulated radiotherapy), the incidence of acute and chronic gastrointestinal toxicities has already been reduced.","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Arians', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany. nathalie.arians@med.uni-heidelberg.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Häfner', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Lang', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Wark', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.'}, {'ForeName': 'Stefan A', 'Initials': 'SA', 'LastName': 'Koerber', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.'}, {'ForeName': 'Adriane', 'Initials': 'A', 'LastName': 'Hommertgen', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.'}]",BMC cancer,['10.1186/s12885-020-6547-7']
3264,32001517,Effectiveness of an e-health tennis-specific injury prevention programme: randomised controlled trial in adult recreational tennis players.,"BACKGROUND


Despite reported injury rates of up to 3 per 1000 hours exposure, there are no evidence-based prevention programmes in tennis.
PURPOSE


To evaluate the effectiveness of an e-health prevention programme for reducing tennis injury prevalence.
STUDY DESIGN


Two-arm, researcher-blinded randomised controlled trial.
METHODS


Adult tennis players of all playing levels were randomised in an unsupervised programme lasting 12 weeks (TennisReady group or control group). The primary outcome was the overall injury prevalence over a 16-week period, measured at 2 weekly intervals with the Oslo Sports and Trauma Research Centre questionnaire. Estimates for the primary outcome and associated 95% CIs were obtained using generalised estimating equation models. Secondary outcome scores included prevalence of substantial injuries, overall incidence, adherence and time-loss injuries.
RESULTS


A total of 579 (83%) (TennisReady n=286, control n=293) participants were included in the primary analysis. The mean injury prevalence was 37% (95% CI 33% to 42%) in the TennisReady vs 38% (95% CI 34% to 42%) in the control group (adjusted p-value 0.93). The prevalence of substantial injuries was 11% (95% CI 9% to 14%) in the TennisReady vs 12% (95% CI 9% to 15%) in the control group (p value of 0.79). Analysis of the secondary outcome scores showed no difference between groups. The mean prevalence rates between high (8%) and low (92%) adherent groups were 32% (95% CI 23% to 44%) and 37% (95% CI 33% to 42%), respectively (p value 0.36).
CONCLUSION


Providing an unsupervised e-health tennis-specific exercise programme did not reduce the injury rates and should not be implemented.
TRIAL REGISTRATION NUMBER


NTR6443.",2020,"Providing an unsupervised e-health tennis-specific exercise programme did not reduce the injury rates and should not be implemented.
","['A total of 579 (83%) (TennisReady n=286, control n=293) participants were included in the primary analysis', 'Adult tennis players of all playing levels', 'adult recreational tennis players']","['e-health tennis-specific injury prevention programme', 'e-health prevention programme', 'unsupervised programme lasting 12 weeks (TennisReady group or control group']","['prevalence of substantial injuries, overall incidence, adherence and time-loss injuries', 'mean prevalence rates', 'mean injury prevalence', 'overall injury prevalence over a 16-week period, measured at 2 weekly intervals with the Oslo Sports and Trauma Research Centre questionnaire', 'prevalence of substantial injuries']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.386742,"Providing an unsupervised e-health tennis-specific exercise programme did not reduce the injury rates and should not be implemented.
","[{'ForeName': 'Haiko Ivo Maria Franciscus Lodewijk', 'Initials': 'HIMFL', 'LastName': 'Pas', 'Affiliation': 'Amsterdam UMC, Univ of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Babette M', 'Initials': 'BM', 'LastName': 'Pluim', 'Affiliation': 'Amsterdam Collaboration on Health & Safety in Sports (ACHSS), Amsterdam UMC IOC Research Center of Excellence, Amsterdam, The Netherlands.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Kilic', 'Affiliation': 'Amsterdam UMC, Univ of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'Verhagen', 'Affiliation': 'Amsterdam Collaboration on Health & Safety in Sports (ACHSS), Amsterdam UMC IOC Research Center of Excellence, Amsterdam, The Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gouttebarge', 'Affiliation': 'Amsterdam UMC, Univ of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Holman', 'Affiliation': 'Clinical Research Unit, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Maarten H', 'Initials': 'MH', 'LastName': 'Moen', 'Affiliation': 'Amsterdam UMC, Univ of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Gino M', 'Initials': 'GM', 'LastName': 'Kerkhoffs', 'Affiliation': 'Amsterdam UMC, Univ of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes L', 'Initials': 'JL', 'LastName': 'Tol', 'Affiliation': 'Academic Center for Evidence-based Sports medicine (ACES), Amsterdam UMC, Amsterdam Movement Sciences, Amsterdam, The Netherlands j.l.tol@amsterdamumc.nl.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101142']
3265,32001798,"Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study.","In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients (N = 569) with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1-21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35-0.55; P < 0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001). Median time to next therapy was prolonged with D-Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31-0.50; P < 0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42-0.68; P < 0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse.",2020,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","['Patients (N\u2009=\u2009569) with ≥1 prior line received', 'relapsed/refractory multiple myeloma']","['Rd (lenalidomide', 'POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd', 'Daratumumab plus lenalidomide and dexamethasone', 'dexamethasone, 40\u2009mg, weekly)\u2009±\u2009daratumumab']","['Median time to next therapy', 'D-Rd prolonged progression-free survival (PFS', 'risk of disease progression or death', 'MRD negativity', 'Minimal residual disease (MRD', 'overall response rate (ORR', 'ORR', 'Median PFS on subsequent line of therapy (PFS2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]",569.0,0.152505,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","[{'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'University of Calgary, Charbonneau Cancer Research Institute, Calgary, AB, Canada. nbahlis@ucalgary.ca.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'The National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Darrell J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'QEII Health Sciences Center and Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': ""Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': ""St James's Institute of Oncology, Leeds Teaching Hospitals National Health Service Trust and University of Leeds, Leeds, UK.""}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Leiba', 'Affiliation': 'Assuta University Hospital, Faculty of Health Science, Ben-Gurion University of the Negev, Beersheba, Israel.'}, {'ForeName': 'P Joy', 'Initials': 'PJ', 'LastName': 'Ho', 'Affiliation': 'Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Kihyun', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'Department of Hematology, National Hospital Organization Disaster Medical Center of Japan, Tachikawa, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Krevvata', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Okonkwo', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Trivedi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra-Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain.'}]",Leukemia,['10.1038/s41375-020-0711-6']
3266,31992545,Forty-five per cent lower acute injury incidence but no effect on overuse injury prevalence in youth floorball players (aged 12-17 years) who used an injury prevention exercise programme: two-armed parallel-group cluster randomised controlled trial.,"OBJECTIVE


To study whether an injury prevention exercise programme would reduce the number of injuries in youth floorball players. METHODS : 81 youth community level floorball teams (48 clusters=clubs) with female and male players (12-17 years) were cluster-randomised into an intervention or control group. Intervention group coaches were instructed to use the Swedish  Knee Control  programme and a standard running warm-up before every training session, and the running warm-up before every match, during the season. Control teams continued usual training. Teams were followed during the 2017/2018 competitive season (26 weeks). Player exposure to floorball and occurrence of acute and overuse injuries were reported weekly via a web-based player survey using the Oslo Sports Trauma Research Centre Questionnaire. RESULTS : 17 clusters (301 players) in the intervention group and 12 clusters (170 players) in the control group were included for analyses. There were 349 unique injuries in 222 players. The intervention group had a 35% lower incidence of injuries overall than the control group (adjusted incidence rate ratio (IRR) 0.65, 95% CI 0.52 to 0.81). The absolute risk reduction was 6.6% (95% CI 3.2 to 10.0), and the number needed to treat was 152 hours of floorball exposure (95% CI 100 to 316). Intervention group teams had a 45% lower incidence of acute injuries (adjusted IRR 0.55, 95% CI 0.37 to 0.83). There was no difference in the prevalence of overuse injuries (adjusted prevalence rate ratio 0.96, 95% CI 0.73 to 1.26). CONCLUSION : The  Knee Control  injury prevention programme reduced acute injuries in youth floorball players; there was no effect on overuse injuries.
TRIAL REGISTRATION NUMBER


Clinical Trials NCT03309904.",2020,"The  Knee Control  injury prevention programme reduced acute injuries in youth floorball players; there was no effect on overuse injuries.
","[' 81 youth community level floorball teams (48 clusters=clubs) with female and male players (12-17 years', '349 unique injuries in 222 players', 'youth floorball players', 'youth floorball players (aged 12-17 years) who used an injury prevention exercise programme']","['Intervention group coaches were instructed to use the Swedish  Knee Control  programme and a standard running warm-up before every training session', 'injury prevention exercise programme']","['incidence of injuries overall', 'overuse injury prevalence', 'absolute risk reduction', 'number of injuries', 'acute injuries', 'prevalence of overuse injuries', 'incidence of acute injuries', 'overuse injuries']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035127', 'cui_str': 'Repetitive Stress Injury'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.124536,"The  Knee Control  injury prevention programme reduced acute injuries in youth floorball players; there was no effect on overuse injuries.
","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Åkerlund', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Waldén', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Sport Without Injury ProgrammE (SWIPE), Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sofi', 'Initials': 'S', 'LastName': 'Sonesson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hägglund', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden martin.hagglund@liu.se.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101295']
3267,32143653,Influence of physical strain at high altitude on the quality of cardiopulmonary resuscitation.,"BACKGROUND


High quality cardiopulmonary resuscitation is a key factor in survival with good overall quality of life after out-of-hospital cardiac arrest. Current evidence is predominantly based on studies conducted at low altitude, and do not take into account the special circumstances of alpine rescue missions. We therefore aimed to investigate the influence of physical strain at high altitude on the quality of cardiopulmonary resuscitation.
METHODS


Alpine field study. Twenty experienced mountaineers of the Austrian Mountain Rescue Service trained in Basic Life Support (BLS) performed BLS on a manikin in groups of two for 16 min. The scenario was executed at baseline altitude and immediately after a quick ascent over an altitude difference of 1200 m at 3454 m above sea level. The sequence of scenarios was randomised for a cross over analysis. Quality of CPR and exhaustion of participants (vital signs, Borg-Scale, Nine hole peg test) were measured and compared between high altitude and baseline using random-effects linear regression models.
RESULTS


The primary outcome of chest compression depth significantly decreased at high altitude compared to baseline by 1 cm (95% CI 0.5 to 1.3 cm, p < 0.01). There was a significant reduction in the proportion of chest compressions in the target depth (at least 5 cm pressure depth) by 55% (95% CI 29 to 82%, p < 0.01) and in the duration of the release phase by 75 ms (95% CI 48 to 101 ms, p < 0.01). No significant difference was found regarding hands-off times, compression frequency or exhaustion.
CONCLUSION


Physical strain during a realistic alpine rescue mission scenario at high altitude led to a significant reduction in quality of resuscitation. Resuscitation guidelines developed at sea level are not directly applicable in the mountain terrain.",2020,"There was a significant reduction in the proportion of chest compressions in the target depth (at least 5 cm pressure depth) by 55% (95% CI 29 to 82%, p < 0.01) and in the duration of the release phase by 75 ms (95% CI 48 to 101 ms, p < 0.01).",['Twenty experienced mountaineers of the Austrian Mountain Rescue Service trained in'],['Basic Life Support (BLS) performed BLS'],"['hands-off times, compression frequency or exhaustion', 'proportion of chest compressions', 'Quality of CPR and exhaustion of participants (vital signs, Borg-Scale, Nine hole peg test', 'quality of resuscitation', 'chest compression depth']","[{'cui': 'C0026623', 'cui_str': 'Mountaineerings'}, {'cui': 'C0337795', 'cui_str': 'Austrians (ethnic group)'}, {'cui': 'C0442533', 'cui_str': 'Mountain (environment)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0085873', 'cui_str': 'Basic life support (procedure)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0518766'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test (assessment scale)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]",,0.0319837,"There was a significant reduction in the proportion of chest compressions in the target depth (at least 5 cm pressure depth) by 55% (95% CI 29 to 82%, p < 0.01) and in the duration of the release phase by 75 ms (95% CI 48 to 101 ms, p < 0.01).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Egger', 'Affiliation': 'Mountain Rescue Service Austria, Schelleingasse 26/2/2, 1040, Wien, Austria.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Niederer', 'Affiliation': 'Mountain Rescue Service Austria, Schelleingasse 26/2/2, 1040, Wien, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Tscherny', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Wien, Austria.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Burger', 'Affiliation': 'Mountain Rescue Service Austria, Schelleingasse 26/2/2, 1040, Wien, Austria.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Fuhrmann', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Wien, Austria.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Kienbacher', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Wien, Austria.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Roth', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Wien, Austria. dominik.roth@meduniwien.ac.at.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schreiber', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Wien, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Herkner', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Wien, Austria.'}]","Scandinavian journal of trauma, resuscitation and emergency medicine",['10.1186/s13049-020-0717-0']
3268,31964346,"Efficacy of companion-integrated childbirth preparation for childbirth fear, self-efficacy, and maternal support in primigravid women in Malawi.","BACKGROUND


In resource-limited settings, childbirth remains a matter of life and death. High levels of childbirth fear in primigravid women are inevitable. To date, few studies have explored interventions to reduce childbirth fear in primigravid women. This study aimed to evaluate the efficacy of companion-integrated childbirth preparation (C-ICP) during late pregnancy for reducing childbirth fear and improving childbirth self-efficacy, birth companion support, and other selected pregnancy outcomes in primigravid women.
METHODS


A quasi-experimental study was carried out using a non-equivalent control group design to recruit a sample of 70 primigravid women in hospital maternity waiting homes in the intervention and control groups, with 35 in each group. The primigravid women and their birth companions in the intervention group received two sessions of companion-integrated childbirth preparation, whereas the control group received routine care. A questionnaire that incorporated the childbirth attitude questionnaire (CAQ), the childbirth self-efficacy inventory (CBSEI), the birth companion support questionnaire (BCSQ), and a review checklist of selected pregnancy outcomes was used to collect data. Pretest and post-test data were analyzed using simple linear regression. Beta coefficients were adjusted at a 95% confidence interval with statistical significance set at a P-value of < 0.05 using Statistical Package for the Social Sciences version 25.
RESULTS


At pretest, mean scores were similar in the intervention and control groups. At post-test, being in the intervention group significantly decreased childbirth fears (β: = - .866, t (68) = - 14.27, p < .001) and significantly increased childbirth self-efficacy (β: = .903, t (68) = 17.30, p < .001). In addition, being in the intervention group significantly increased birth companion support (β: = - 0.781, t (68) = 10.32, p < .001). However, no statistically significant differences regarding pregnancy outcomes were observed between the study groups (Mann-Whiney U test, p > .05).
CONCLUSION


The findings of our study suggest that C-ICP is a promising intervention to reduce childbirth fear while increasing childbirth self-efficacy and maternal support. We recommend the inclusion of C-ICP for primigravid women during late pregnancy in resource-limited settings.",2020,"At post-test, being in the intervention group significantly decreased childbirth fears (β: = - .866, t (68) = - 14.27, p < .001) and significantly increased childbirth self-efficacy (β: = .903, t (68) = 17.30, p < .001).","['primigravid women', '70 primigravid women in hospital maternity waiting homes in the intervention and control groups, with 35 in each group', 'primigravid women in Malawi']","['control group received routine care', 'C-ICP', 'companion-integrated childbirth preparation (C-ICP', 'companion-integrated childbirth preparation']","['childbirth attitude questionnaire (CAQ), the childbirth self-efficacy inventory (CBSEI), the birth companion support questionnaire (BCSQ', 'childbirth fear, self-efficacy, and maternal support', 'childbirth fears', 'childbirth self-efficacy', 'Beta coefficients', 'birth companion support', 'pregnancy outcomes', 'High levels of childbirth fear']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0335343', 'cui_str': 'Companions'}, {'cui': 'C0150169', 'cui_str': 'Childbirth preparation'}]","[{'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0335343', 'cui_str': 'Companions'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",70.0,0.0709518,"At post-test, being in the intervention group significantly decreased childbirth fears (β: = - .866, t (68) = - 14.27, p < .001) and significantly increased childbirth self-efficacy (β: = .903, t (68) = 17.30, p < .001).","[{'ForeName': 'Berlington M J', 'Initials': 'BMJ', 'LastName': 'Munkhondya', 'Affiliation': 'Xiangya School of Nursing of Central South University, 172 Tong Zi Po Road, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Tiwonge Ethel', 'Initials': 'TE', 'LastName': 'Munkhondya', 'Affiliation': 'Faculty of Midwifery, Neonatal and Reproductive Health Studies, Kamuzu College of Nursing, University of Malawi, P/Bag 1, Lilongwe, Malawi.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Chirwa', 'Affiliation': 'Faculty of Midwifery, Neonatal and Reproductive Health Studies, Kamuzu College of Nursing, University of Malawi, P/Bag 1, Lilongwe, Malawi.'}, {'ForeName': 'Honghong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Xiangya School of Nursing of Central South University, 172 Tong Zi Po Road, Changsha, 410013, Hunan, China. Honghong_wang@hotmail.com.'}]",BMC pregnancy and childbirth,['10.1186/s12884-019-2717-5']
3269,32111701,A Coaching Program to Improve Dietary Intake of Patients with CKD: ENTICE-CKD.,"BACKGROUND AND OBJECTIVES


The dietary self-management of CKD is challenging. Telehealth interventions may provide an effective delivery method to facilitate sustained dietary change.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


This pilot, randomized, controlled trial evaluated secondary and exploratory outcomes after a dietitian-led telehealth coaching intervention to improve diet quality in people with stage 3-4 CKD. The intervention group received phone calls every 2 weeks for 3 months (with concurrent, tailored text messages for 3 months), followed by 3 months of tailored text messages without telephone coaching, to encourage a diet consistent with CKD guidelines. The control group received usual care for 3 months, followed by nontailored, educational text messages for 3 months.
RESULTS


Eighty participants (64% male), aged 62±12 years, were randomized to the intervention or control group. Telehealth coaching was safe, with no adverse events or changes to serum biochemistry at any time point. At 3 months, the telehealth intervention, compared with the control, had no detectable effect on overall diet quality on the Alternative Health Eating Index (3.2 points, 95% confidence interval, -1.3 to 7.7), nor at 6 months (0.5 points, 95% confidence interval, -4.6 to 5.5). There was no change in clinic BP at any time point in any group. There were significant improvements in several exploratory diet and clinical outcomes, including core food group consumption, vegetable servings, fiber intake, and body weight.
CONCLUSIONS


Telehealth coaching was safe, but appeared to have no effect on the Alternative Healthy Eating Index or clinic BP. There were clinically significant changes in several exploratory diet and clinical outcomes, which require further investigation.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Evaluation of Individualized Telehealth Intensive Coaching to Promote Healthy Eating and Lifestyle in CKD (ENTICE-CKD), ACTRN12616001212448.",2020,"At 3 months, the telehealth intervention, compared with the control, had no detectable effect on overall diet quality on the Alternative Health Eating Index (3.2 points, 95% confidence interval, -1.3 to 7.7), nor at 6 months (0.5 points, 95% confidence interval, -4.6 to 5.5).","['Patients with CKD', 'people with stage 3-4 CKD', 'Eighty participants (64% male), aged 62±12 years']","['dietitian-led telehealth coaching intervention', 'usual care for 3 months, followed by nontailored, educational text messages for 3 months']","['Alternative Health Eating Index', 'clinic BP', 'several exploratory diet and clinical outcomes, including core food group consumption, vegetable servings, fiber intake, and body weight', 'Alternative Healthy Eating Index or clinic BP', 'diet quality', 'overall diet quality', 'several exploratory diet and clinical outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0615138,"At 3 months, the telehealth intervention, compared with the control, had no detectable effect on overall diet quality on the Alternative Health Eating Index (3.2 points, 95% confidence interval, -1.3 to 7.7), nor at 6 months (0.5 points, 95% confidence interval, -4.6 to 5.5).","[{'ForeName': 'Jaimon T', 'Initials': 'JT', 'LastName': 'Kelly', 'Affiliation': 'Faculty of Health Science and Medicine and jaimon.kelly@uq.edu.au.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Conley', 'Affiliation': 'Department of Nutrition and Dietetics and.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Hoffmann', 'Affiliation': 'Centre for Research in Evidence Based Practice, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Craig', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Tong', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dianne P', 'Initials': 'DP', 'LastName': 'Reidlinger', 'Affiliation': 'Faculty of Health Science and Medicine and.'}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Reeves', 'Affiliation': 'School of Public Health, Faculty of Medicine and.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rathika', 'Initials': 'R', 'LastName': 'Krishnasamy', 'Affiliation': 'Department of Nephrology, Sunshine Coast University Hospital, Birtinya, Queensland, Australia.'}, {'ForeName': 'Jagadeesh', 'Initials': 'J', 'LastName': 'Kurtkoti', 'Affiliation': 'Department of Renal Medicine, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Suetonia C', 'Initials': 'SC', 'LastName': 'Palmer', 'Affiliation': 'Department of Medicine, University of Otago Christchurch, Christchurch, New Zealand; and.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Centre for Kidney Disease Research, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'Faculty of Health Science and Medicine and.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.12341019']
3270,31187126,"Effectiveness and Cost of Organized Outreach for Colorectal Cancer Screening: A Randomized, Controlled Trial.","BACKGROUND


Colorectal cancer (CRC) screening remains underused, especially in safety-net systems. The objective of this study was to determine the effectiveness, costs, and cost-effectiveness of organized outreach using fecal immunochemical tests (FITs) compared with usual care.
METHODS


Patients age 50-75 years eligible for CRC screening from eight participating primary care safety-net clinics were randomly assigned to outreach intervention with usual care vs usual care alone. The intervention included a mailed postcard and call, followed by a mailed FIT kit, and a reminder phone call if the FIT kit was not returned. The primary outcome was screening participation at 1 year and a microcosting analysis of the outreach activities with embedded long-term cost-effectiveness of outreach. All statistical tests were two-sided.
RESULTS


A total of 5386 patients were randomly assigned to the intervention group and 5434 to usual care. FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs 37.4%, P < .001; difference = 20.5%, 95% confidence interval = 18.6% to 22.4%). In the intervention group, FIT completion rate was higher in patients who had previously completed a FIT vs those who had not (71.9% vs 35.7%, P < .001). There was evidence of effect modification of the intervention by language, and clinic. Outreach cost approximately $23 per patient and $112 per additional patient screened. Projecting long-term outcomes, outreach was estimated to cost $9200 per quality-adjusted life-year gained vs usual care.
CONCLUSION


Population-based management with organized FIT outreach statistically significantly increased CRC screening and was cost-effective in a safety-net system. The sustainability of the program and any impact of economies of scale remain to be determined.",2020,"FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs. 37.4%, P < 0.001; difference 20.5%, 95% CI 18.6-22.4%).","['colorectal cancer screening', '5,386 patients', 'Patients aged 50-75 years eligible for CRC screening from eight participating primary care safety-net clinics']","['outreach intervention with usual care versus usual care alone', 'organized outreach', 'organized outreach using fecal immunochemical tests (FIT']","['FIT completion rate', 'FIT screening', 'effectiveness, costs, and cost-effectiveness', 'Outreach cost', 'screening participation at one year and a microcosting analysis of the outreach activities with embedded long-term cost-effectiveness of outreach', 'CRC screening']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3661444', 'cui_str': 'Safety-net Clinics'}]","[{'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}]",5386.0,0.109557,"FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs. 37.4%, P < 0.001; difference 20.5%, 95% CI 18.6-22.4%).","[{'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Somsouk', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Rachocki', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Ajitha', 'Initials': 'A', 'LastName': 'Mannalithara', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Laleau', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Grimes', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Issaka', 'Affiliation': 'Clinical Research and Public Health Sciences Divisions, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Department of Public Health, San Francisco, CA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'Shapiro', 'Affiliation': 'CDC, Atlanta, GA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Ladabaum', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Stanford University, Stanford, CA.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djz110']
3271,31713267,"Phase 2, randomized, double-blind, placebo-controlled, 4-week study to evaluate the safety and efficacy of OPA- 15406 (difamilast), a new topical selective phosphodiesterase type-4 inhibitor, in Japanese pediatric patients aged 2-14 years with atopic dermatitis.","The safety and efficacy of OPA-15406 (international non-proprietary name, difamilast; also referred to as MM36), a new topical, selective phosphodiesterase type-4 inhibitor, in Japanese pediatric patients with atopic dermatitis aged 2-14 years were evaluated in a phase 2, randomized, double-blind, vehicle-controlled, 4-week study. Seventy-three patients were randomized 1:1:1 to receive OPA-15406 0.3%, OPA-15406 1% or vehicle ointment twice daily for 4 weeks. The mean age of patients was similar across treatment groups. No deaths or serious treatment-emergent adverse events were reported; all treatment-emergent adverse events were mild or moderate in severity. The incidence of treatment-emergent adverse events leading to treatment discontinuation was 4.2% (1/24) in the OPA-15406 0.3% group, 4.0% (1/25) in the OPA-15406 1% group and 16.7% (4/24) in the vehicle group, all of which were worsening of atopic dermatitis. Both OPA-15406 groups demonstrated a higher incidence of success in the Investigator Global Assessment score compared with the vehicle group over the 4-week study. The OPA-15406 groups also showed greater improvements from baseline compared with the vehicle group in the Investigator Global Assessment score, Eczema Area and Severity Index overall score and subscale (erythema, induration/papulation, excoriation and lichenification) scores, Visual Analog Scale pruritus score, Patient-Oriented Eczema Measure score, and percentage of affected body surface area over the 4-week study. Topical OPA-15406 twice daily for 4 weeks was considered a safe and effective treatment option in this phase 2 study in pediatric patients with atopic dermatitis, and phase 3 development is currently ongoing.",2020,No deaths or serious treatment-emergent adverse events were reported; all treatment-emergent adverse events were mild or moderate in severity.,"['Seventy-three patients', 'Japanese pediatric patients with atopic dermatitis aged 2-14\xa0years', 'pediatric patients with atopic dermatitis', 'Japanese pediatric patients aged 2-14 years with atopic dermatitis']","['OPA- 15406 (difamilast', 'OPA-15406 0.3%, OPA-15406 1% or vehicle ointment', 'Topical OPA-15406', 'placebo', 'OPA-15406']","['deaths or serious treatment-emergent adverse events', 'worsening of atopic dermatitis', 'Investigator Global Assessment score', 'Investigator Global Assessment score, Eczema Area and Severity Index overall score and subscale (erythema, induration/papulation, excoriation and lichenification) scores, Visual Analog Scale pruritus score, Patient-Oriented Eczema Measure score, and percentage of affected body surface area', 'safety and efficacy']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0332534', 'cui_str': 'Induration (morphologic abnormality)'}, {'cui': 'C0015256', 'cui_str': 'Excoriation of skin (disorder)'}, {'cui': 'C0023653', 'cui_str': 'Lichenification (morphologic abnormality)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C4304940', 'cui_str': 'Patient-Oriented Eczema Measure score'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",73.0,0.119425,No deaths or serious treatment-emergent adverse events were reported; all treatment-emergent adverse events were mild or moderate in severity.,"[{'ForeName': 'Hidehisa', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Baba', 'Affiliation': ""Kanagawa Children's Medical Center, Kanagawa, Japan.""}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Oshiden', 'Affiliation': 'Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Abe', 'Affiliation': 'Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Hidetsugu', 'Initials': 'H', 'LastName': 'Tsubouchi', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Osaka, Japan.'}]",The Journal of dermatology,['10.1111/1346-8138.15137']
3272,32192595,"A multicenter, randomized, placebo-controlled, double-blind, comparative study of dienogest at 1 mg/day in patients with primary and secondary dysmenorrhea.","OBJECTIVE


To evaluate the efficacy and safety of dienogest (DNG), a progestational 19-norsteroid, in patients with primary and secondary dysmenorrhea.
DESIGN


Phase III, randomized, double-blind, multicenter, placebo-controlled study.
SETTING


Clinical study sites in Japan.
PATIENT(S)


Ninety-four women with dysmenorrhea.
INTERVENTION(S)


Random assignment to receive DNG (1 mg/day, orally) or placebo for 12 weeks; patients treated for anemia before randomization in cases of complicated anemia.
MAIN OUTCOME MEASURE(S)


Change in the dysmenorrhea score from baseline to week 12 of treatment with visual analog scale used for pain assessment.
RESULT(S)


The DNG group was superior to the placebo group in terms of the change from baseline in the dysmenorrhea score at week 12 of treatment in patients with dysmenorrhea. In both primary and secondary dysmenorrhea, the DNG group was superior to the placebo group for each diagnostic category. The mean serum estradiol concentrations were similar between the DNG and the placebo groups. Although the incidence of irregular uterine bleeding was higher in the DNG group, there were no severe or serious events. Most events of genital bleeding were spotting or breakthrough bleeding, suggesting DNG was well tolerated.
CONCLUSION(S)


In both primary and secondary dysmenorrhea, DNG at 1 mg/day relieved pain and was well tolerated.
CLINICAL TRIAL REGISTRATION NUMBER


JapicCTI-173547(en).",2020,The DNG group was superior to the placebo group in terms of the change from baseline in the dysmenorrhea score at week 12 of treatment in patients with dysmenorrhea.,"['Clinical study sites in Japan', 'patients with primary and secondary dysmenorrhea', '\n\n\nNinety-four women with dysmenorrhea']","['dienogest (DNG', 'placebo', 'DNG']","['visual analog scale used for pain assessment', 'tolerated', 'dysmenorrhea score', 'mean serum estradiol concentrations', 'pain', 'irregular uterine bleeding']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0232944', 'cui_str': 'Secondary dysmenorrhea (disorder)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}]","[{'cui': 'C0057916', 'cui_str': 'dienogest'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0156404', 'cui_str': 'Irregular Menses'}]",94.0,0.429328,The DNG group was superior to the placebo group in terms of the change from baseline in the dysmenorrhea score at week 12 of treatment in patients with dysmenorrhea.,"[{'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tokyo, Tokyo, Japan. Electronic address: yutakaos-tky@umin.ac.jp.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Clinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kanda', 'Affiliation': 'Clinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.'}]",Fertility and sterility,['10.1016/j.fertnstert.2019.11.010']
3273,32150060,Impact of supraglottic device with assist ventilation under general anesthesia combined with nerve block in uniportal video-assisted thoracoscopic surgery.,"BACKGROUND


With the improvement of anesthesia and surgical techniques, supraglottic device with assist ventilation under general anesthesia (GA) combined with nerve block is gradually applied to video-assisted thoracoscopic surgery. However, the safety of assist ventilation has not been fully confirmed, and a large number of samples should be studied in clinical exploration.
METHODS


The subjects included 120 patients, undergoing elective thoracoscopic GA, with American Society of Anesthesiologists (ASA) physical status I or II, were randomly divided into 3 groups, 40 cases in each group. Group T: received double-lumen bronchial intubation, Group I: received intercostal nerve block using a supraglottic device, Group P: received paravertebral nerve block using a supraglottic device. Mean arterial pressure, heart rate, saturation of pulse oximetry and surgical field satisfaction, general anesthetic dosage and recovery time were recorded before induction of GA (T0), at the start of the surgical procedure (T1), 15 minutes later (T2), 30 minutes later (T3), and before the end of the surgical procedure (T4). Static and dynamic pain rating (NRS) and Ramsay sedation score were recorded 2 hours after surgery (T5), 12 hours after surgery (T6), 24 hours after surgery (T7), time to get out of bed, hospitalization time and cost, patient satisfaction and adverse reactions.
RESULTS


There was no significant difference with the surgical visual field of the 3 groups (P > .05). The MAP, HR and SpO2 of the 3 groups were decreased from T2 to T3 compared with T0(P < .05). Compared with group T: the total dosage of GA was reduced in group I and group P, the recovery time was shorter, the time to get out of bed was earlier (P < .05), the hospitalization time was shortened, the hospitalization cost was lower, and the patient satisfaction was higher (P < .05). The static and dynamic NRS scores were lower from T5 to T7 (P < .05). Ramsay sedation scores were higher (P < .05), and the incidence of adverse reactions was lower (P < .05). Comparison between group I and group P: Dynamic NRS score of group P was lower from T6 to T7 (P < .05).
CONCLUSION


Supraglottic device with assist ventilation under general anesthesia combined with nerve block in uniportal video-assisted thoracoscopic surgery is safe and feasible.",2020,"The MAP, HR and SpO2 of the 3 groups were decreased from T2 to T3 compared with T0(P < .05).","['subjects included 120 patients, undergoing elective thoracoscopic GA, with American Society of Anesthesiologists (ASA) physical status I or II']","['supraglottic device with assist ventilation under general anesthesia combined with nerve block', 'supraglottic device with assist ventilation under general anesthesia (GA) combined with nerve block', 'double-lumen bronchial intubation, Group I: received intercostal nerve block using a supraglottic device, Group P: received paravertebral nerve block using a supraglottic device', 'uniportal video-assisted thoracoscopic surgery', 'Supraglottic device with assist ventilation under general anesthesia combined with nerve block in uniportal video-assisted thoracoscopic surgery']","['Static and dynamic pain rating (NRS) and Ramsay sedation score', 'total dosage of GA', 'recovery time', 'Dynamic NRS score', 'MAP, HR and SpO2', 'incidence of adverse reactions', 'Ramsay sedation scores', 'Mean arterial pressure, heart rate, saturation of pulse oximetry and surgical field satisfaction, general anesthetic dosage and recovery time', 'patient satisfaction', 'surgical visual field', 'hospitalization cost', 'time to get out of bed, hospitalization time and cost, patient satisfaction and adverse reactions', 'time to get out of bed', 'hospitalization time', 'static and dynamic NRS scores']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0442192', 'cui_str': 'Supraglottic (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0554804', 'cui_str': 'Ventilation assistance'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0396632', 'cui_str': 'Endobronchial intubation (procedure)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block (procedure)'}, {'cui': 'C0441849', 'cui_str': 'Group P (qualifier value)'}, {'cui': 'C0198806', 'cui_str': 'Paravertebral anesthesia (procedure)'}, {'cui': 'C4304660', 'cui_str': 'Uniportal video assisted thoracoscopic surgery (procedure)'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0034108', 'cui_str': 'Oximetry, Pulse'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0017302', 'cui_str': 'Anesthetics, General'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0004916', 'cui_str': 'Beds'}]",120.0,0.0652741,"The MAP, HR and SpO2 of the 3 groups were decreased from T2 to T3 compared with T0(P < .05).","[{'ForeName': 'Xiaobing', 'Initials': 'X', 'LastName': 'Xiang', 'Affiliation': 'Institute of Cancer and Basic Medicine (ICBM).'}, {'ForeName': 'Huidan', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Institute of Cancer and Basic Medicine (ICBM).'}, {'ForeName': 'Yingli', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Institute of Cancer and Basic Medicine (ICBM).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Institute of Cancer and Basic Medicine (ICBM).'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Lian', 'Affiliation': 'Institute of Cancer and Basic Medicine (ICBM).'}]",Medicine,['10.1097/MD.0000000000019240']
3274,30837595,Randomized Controlled Trial comparing the effectiveness of structured-play (ENGAGE) and behavior management (TRIPLE P) in reducing problem behaviors in preschoolers.,"Children's behavior problems are a growing concern in our society; and are associated with a wide array of adverse lifespan outcomes. Current treatments are not without limitations and while effective for many, do not help all children. As such, additional treatment options are required. Sixty families of children aged 3 and 4 years participated. In order to participate, children needed to have a T-score of 60 or above on the parent rated Hyperactivity subscale on the BASC-2. Families were randomly assigned to either a structured play-based intervention (ENGAGE; n = 29), or to the current gold standard treatment for preschool behavior problems, behavior management (Triple P; n = 31). This trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR); trial number ACTRN12617001432303; trial web address: http://www.anzctr.org.au/ACTRN12617001432303.aspx ; date registered; 10/10/2017. ENGAGE was found to be as effective as Triple P in reducing parent-rated problem behaviors in pre-schoolers (i.e., Hyperactivity, Attention Problems, and Aggression); with gains maintained over a 12-month follow-up period, for both interventions. These findings indicate that structured play is an equally effective alternative way to manage difficult behavior in preschoolers and compliments our current treatment options.",2019,"ENGAGE was found to be as effective as Triple P in reducing parent-rated problem behaviors in pre-schoolers (i.e., Hyperactivity, Attention Problems, and Aggression); with gains maintained over a 12-month follow-up period, for both interventions.","['preschoolers', ""Children's behavior problems"", 'Sixty families of children aged 3 and 4 years participated']","['structured-play (ENGAGE) and behavior management (TRIPLE P', 'structured play-based intervention (ENGAGE; n\u2009=\u200929), or to the current gold standard treatment for preschool behavior problems, behavior management (Triple P; n\u2009=\u200931']",[],"[{'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0150143', 'cui_str': 'Behavior modification case management'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",[],60.0,0.128123,"ENGAGE was found to be as effective as Triple P in reducing parent-rated problem behaviors in pre-schoolers (i.e., Hyperactivity, Attention Problems, and Aggression); with gains maintained over a 12-month follow-up period, for both interventions.","[{'ForeName': 'Dione', 'Initials': 'D', 'LastName': 'Healey', 'Affiliation': 'Department of Psychology, Box 56, University of Otago, Dunedin, 9054, New Zealand. dionehealey@psy.otago.ac.nz.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Healey', 'Affiliation': 'Information Technology Services, Box 56, University of Otago, Dunedin, 9054, New Zealand.'}]",Scientific reports,['10.1038/s41598-019-40234-0']
3275,32107975,"Are workplace-based assessment methods (DOPS and Mini-CEX) effective in nursing students' clinical skills? A single-blind randomized, parallel group, controlled trial.","Background:  Evaluation of clinical skills is critically important for nursing students. However, the quality of evaluation tools is poor. Objectives:  To evaluate the effectiveness of Direct Observation of Procedural Skills (DOPS) and Mini-Clinical Evaluation Exercise (Mini-CEX) on clinical skills of nursing students. Methods:  This study was conducted among 108 senior nursing students. Mini-CEX and DOPS were utilized to evaluate clinical skills in the intervention group. Results:  The mean of students' scores in all of the five procedures was significantly higher in the intervention group compared to control group.. Students' scores for the procedures significantly raised through the first stage of DOPS and Mini-CEX to the third stage. Conclusions:  Utilization of DOPS and Mini-CEX for evaluation of clinical skills in nursing students effectively enhance their learning ability. Implementing of such assessment methods lead to promoting clinical skills of students which eventually help them to provide high quality care for their patients.",2019,"Repeated measure ANOVA showed significant improvement in the students' scores on the tests assessing the skill of suctioning, dressing change, intravenous catheterization, patient education and writing a report.","['108 senior nursing students', 'nursing students', 'comparison group in a teaching hospital in Urmia, Iran (2016']","['Direct Observation of Procedural Skills (DOPS) and Mini Clinical Evaluation Exercise (Mini-CEX', 'Mini-CEX and DOPS', 'DOPS and Mini-CEX']","['skill of suctioning, dressing change, intravenous catheterization, patient education and writing a report', ""mean of students' scores""]","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0085671', 'cui_str': 'Dressing change'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",108.0,0.0455043,"Repeated measure ANOVA showed significant improvement in the students' scores on the tests assessing the skill of suctioning, dressing change, intravenous catheterization, patient education and writing a report.","[{'ForeName': 'Madineh', 'Initials': 'M', 'LastName': 'Jasemi', 'Affiliation': 'Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Ahangarzadeh Rezaie', 'Affiliation': 'Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Masumeh', 'Initials': 'M', 'LastName': 'Hemmati Maslakpak', 'Affiliation': 'Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Parizad', 'Affiliation': 'Faculty of Nursing and Midwifery, Urmia University of Medical Sciences, Urmia, Iran.'}]",Contemporary nurse,['10.1080/10376178.2020.1735941']
3276,32112718,Does Piezosurgery Decrease Patient Morbidity in Surgically Assisted Rapid Palatal Expansion Compared With Saw and Burrs?,"PURPOSE


The present study compared the postoperative pain, edema, patient satisfaction, and operating time with the use of piezosurgery, a reciprocal microsaw, and conventional burrs in the surgically assisted rapid palatal expansion (SARPE) technique for the correction of transversal maxillary deficiency. The results of the present study may help clinicians minimize the postoperative complaints of patients after SARPE.
PATIENTS AND METHODS


The present randomized single-blind study included patients who had undergone SARPE with piezosurgery, a reciprocating microsaw, or conventional burrs. To determine the facial norms and postoperative facial edema, 4 anatomic distances were measured on the patients' face using the modified flexible ruler method. The mean facial edema score was determined to evaluate and compare the overall edema among the groups. Two separate visual analog scales were used to assess patients' postoperative pain and intraoperative satisfaction. The duration of the osteotomies was recorded. Intragroup data were statistically analyzed via a t test, and intergroup data were analyzed via a nonparametric Kruskal-Wallis test. Spearman's correlation was used to evaluate the relationships among the variables.
RESULTS


For the 80 patients, edema (second day: piezosurgery, 0.53 ± 0.34; microsaw, 0.61 ± 0.30; burrs, 0.94 ± 0.33; P < .001) and pain (piezosurgery, 2.3 ± 0.3; microsaw, 3.6 ± 0.4; burrs, 3.9 ± 0.6; P < .001) were greater for conventional burrs and microsaws, with statistically significant differences. Patient satisfaction (piezosurgery, 8.3 ± 0.3; microsaw, 5.5 ± 0.5; burrs, 5.1 ± 0.9; P < .001) was greater with piezosurgery. However, in the piezosurgery group, the duration of osteotomies was 50% greater (piezosurgery, 16.10 ± 3.30; microsaw, 11.05 ± 2.09; burrs, 11.2 ± 2.14; P < .001).
CONCLUSIONS


The results from the present study have shown that piezosurgery is an effective method for minimizing facial edema and patient morbidity and increasing patient satisfaction during SARPE. Moreover, the use of conventional burrs and microsaws prolonged the duration of facial edema.",2020,"Patient satisfaction (piezosurgery, 8.3 ± 0.3; microsaw, 5.5 ± 0.5; burrs, 5.1 ± 0.9; P < .001) was greater with piezosurgery.","['patients who had undergone SARPE with piezosurgery, a reciprocating microsaw, or conventional burrs']",['surgically assisted rapid palatal expansion (SARPE) technique'],"['duration of the osteotomies', 'facial norms and postoperative facial edema, 4 anatomic distances', 'postoperative pain, edema, patient satisfaction, and operating time with the use of piezosurgery, a reciprocal microsaw, and conventional burrs', 'duration of osteotomies', 'mean facial edema score', 'postoperative pain and intraoperative satisfaction', 'Patient satisfaction', 'duration of facial edema', 'overall edema']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0330093', 'cui_str': 'Burr (substance)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0030212', 'cui_str': 'Palatal Expansion Technic'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0330093', 'cui_str': 'Burr (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0760889,"Patient satisfaction (piezosurgery, 8.3 ± 0.3; microsaw, 5.5 ± 0.5; burrs, 5.1 ± 0.9; P < .001) was greater with piezosurgery.","[{'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Küçükkurt', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Istanbul Aydın University, Istanbul, Turkey. Electronic address: sercankucukkurt@aydin.edu.tr.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Değerliyurt', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Istanbul Aydın University, Istanbul, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.030']
3277,32113882,A randomized clinical trial on the efficacy of a patient-adapted autonomous exercise regime for patients with head and neck cancer.,"Patients undergoing surgical therapy of head and neck malignancies are known to exhibit a high number of comorbidities and frequently present a high nosocomial morbidity. Physiotherapy (PT) improves the clinical course of patients after extensive surgery. The aim of this study was to establish and then compare an additional individualized autonomous exercise plan with standard physiotherapy. 69 consecutive patients undergoing surgical treatment of head and neck cancer were randomized into two groups. The control group received standard clinical physiotherapy, the intervention group an additional autonomous exercise plan, adapted to the patient's performance profile. The patients randomized to the intervention group showed significantly fewer signs of fatigue (5.5 ± 3.5 vs. 3.7 ± 2.7, p = 0.048) and fewer digestive problems (4.7 ± 3.3 vs. 2.3 ± 2.7; p = 0.009) compared with the patients of the control group. In addition, a significantly shorter hospital stay was observed (17.7 ± 6.3 vs. 13.4 ± 3.4 days, p = 0.005), which was positively influenced by the early start of the exercises (r = 0.623, p = 0.001) and frequent practice (r = 0.432, p = 0.031). Patients with head and neck cancer therapy can benefit from an autonomous, individualized exercise plan. In coordination with the physiotherapists, mobilization should be as early and intensive as possible.",2020,The patients randomized to the intervention group showed significantly fewer signs of fatigue (5.5 ± ,"['patients with head and neck cancer', 'Patients undergoing surgical therapy of head and neck malignancies', 'patients after extensive surgery', '69 consecutive patients undergoing surgical treatment of head and neck cancer', 'Patients with head and neck cancer therapy']","['standard clinical physiotherapy, the intervention group an additional autonomous exercise plan', 'additional individualized autonomous exercise plan with standard physiotherapy', 'patient-adapted autonomous exercise regime', 'Physiotherapy (PT']","['shorter hospital stay', 'digestive problems', 'signs of fatigue (5.5\xa0±']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0454291', 'cui_str': 'Exercise regime (regime/therapy)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3844008', 'cui_str': '5.5'}]",69.0,0.0356303,The patients randomized to the intervention group showed significantly fewer signs of fatigue (5.5 ± ,"[{'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Steegmann', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, RWTH Aachen University, Pauwelstr 30, 52074 Aachen, Germany.'}, {'ForeName': 'Alexander K', 'Initials': 'AK', 'LastName': 'Bartella', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Leipzig University, Liebigstr 12, 04103 Leipzig, Germany.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Kloss-Brandstätter', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, RWTH Aachen University, Pauwelstr 30, 52074 Aachen, Germany.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Department of Surgical Sciences, Faculty of Dentistry, Kuwait University, P. O. Box 24923, Safat 13110, Kuwait.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hölzle', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, RWTH Aachen University, Pauwelstr 30, 52074 Aachen, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Lethaus', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Leipzig University, Liebigstr 12, 04103 Leipzig, Germany. Electronic address: bernd.lethaus@medizin.uni-leipzig.de.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2019.12.009']
3278,31996940,"Differential effects of nicotine delivery rate on subjective drug effects, urges to smoke, heart rate and blood pressure in tobacco smokers.","RATIONALE


The nicotine delivery rate is a key feature of tobacco product design, yet there have been limited human studies examining the effects of nicotine as a function of delivery rate.
OBJECTIVE


We developed an intravenous nicotine infusion protocol to evaluate differential effects of nicotine delivery rate on subjective drug effects, smoking urges, abstinence symptoms, heart rate, and blood pressure.
METHODS


Eighteen non-treatment seeking, overnight abstinent male and female smokers (18 to 30 years old), who smoked ≥ 5 cigarettes per day for the past year completed four sessions, in which they were randomly assigned to a saline infusion, or a 1 mg per 70-kg body weight dose of nicotine delivered over 1, 5, or 10 min at rates of 0.24, 0.048, or 0.024 μg/kg/s, respectively.
RESULTS


Smoking urges, as assessed by the Brief Questionnaire of Smoking Urges, were reduced relative to placebo for the 1- and 5-min infusion, but not the 10-min infusion. Although the 1- and 5-min infusions reduced smoking urges to a similar extent, the 1-min infusion induced a greater heart rate and blood pressure increase. Changes to subjective drug effects, heart rate, and blood pressure delineate the differential effects of nicotine delivery rate for these outcomes.
CONCLUSIONS


We have characterized the delivery rate-response curve for a nicotine dose that is roughly the amount of nicotine (~ 1 mg) delivered by smoking a standard tobacco cigarette. Our findings reinforce the importance of nicotine delivery rate when evaluating the potential effects of nicotine from tobacco products.",2020,"RESULTS


Smoking urges, as assessed by the Brief Questionnaire of Smoking Urges, were reduced relative to placebo for the 1- and 5-min infusion, but not the 10-min infusion.","['tobacco smokers', 'Eighteen non-treatment seeking, overnight abstinent male and female smokers (18 to 30\xa0years old), who smoked ≥\u20095 cigarettes per day for the past year completed four sessions']","['nicotine', 'saline infusion']","['subjective drug effects, heart rate, and blood pressure', 'subjective drug effects, urges to smoke, heart rate and blood pressure', 'Brief Questionnaire of Smoking Urges', 'subjective drug effects, smoking urges, abstinence symptoms, heart rate, and blood pressure', 'heart rate and blood pressure increase']","[{'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}]",,0.043994,"RESULTS


Smoking urges, as assessed by the Brief Questionnaire of Smoking Urges, were reduced relative to placebo for the 1- and 5-min infusion, but not the 10-min infusion.","[{'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Jensen', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. kevin.jensen@yale.edu.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Valentine', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sofuoglu', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05463-6']
3279,31989232,Prospective Analysis and Comparison of Periareolar Excision (Delivery) Technique and Pull-Through Technique for the Treatment of Gynecomastia.,"BACKGROUND


Gynecomastia is one of the most common disorders affecting adolescent and adult males. It is a benign disorder but has severe psychological manifestations like low self-confidence, depression, anxiety and social phobia in patients suffering from gynecomastia. Different surgical techniques have been described utilizing a variety of incisions, excisions, lipectomy and liposuction methods. Very frequently, these methods are combined for the gynecomastia treatment with variable reported results. However, there is a lack of studies comparing these techniques. The present study was planned to compare cases of gynecomastia treated by liposuction with periareolar excision (delivery technique) and liposuction with a pull-through technique.
METHOD


A prospective randomized control study was conducted at a tertiary care hospital on 20 patients with gynecomastia. The patients were assigned to either liposuction with periareolar excision (delivery technique) or liposuction with pull-through technique. Anthropometric analysis and breast evaluation questionnaire (BEQ) scores were analyzed and compared before and after the surgery.
RESULTS


The majority of the study subjects were between 21 and 30 years of age. Low self-confidence was the main reason for surgery in most of the cases. Twelve patients had gynecomastia grade IIa and eight had grade IIb. Both groups had similar responses to BEQ scores before and after the surgery with no statistically significant difference. A statistically insignificant difference was observed between the groups on comparison of anthropometric analysis preoperatively and postoperatively. The mean lipoaspirate volume was 280 ml for the pull-through technique and 367 ml for the periareolar excision technique. No complications were observed in cases operated on by the pull-through technique, while two cases (10%) operated on by the periareolar excision had hematomas.
CONCLUSION


Both techniques provide excellent cosmetic results with low risk of complications in both small and moderate breast enlargement with skin excess. The pull-through technique combines the benefits of direct excision of glandular tissues along with the minimally invasive nature of liposuction. Thus, performing the procedure via a single incision without the use of drains is a safer alternative to traditional liposuction with the periareolar excision technique.
LEVEL OF EVIDENCE III


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2020,Both groups had similar responses to BEQ scores before and after the surgery with no statistically significant difference.,"['patients suffering from gynecomastia', 'study subjects were between 21 and 30\xa0years of age', '20 patients with gynecomastia', 'Twelve patients had gynecomastia grade IIa and eight had grade IIb']","['liposuction with periareolar excision (delivery technique) or liposuction with pull-through technique', 'Periareolar Excision', 'liposuction with periareolar excision (delivery technique) and liposuction with a pull-through technique']","['hematomas', 'mean lipoaspirate volume', 'Anthropometric analysis and breast evaluation questionnaire (BEQ) scores', 'BEQ scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018418', 'cui_str': 'Male Breast Enlargement'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0038640', 'cui_str': 'Aspiration Lipectomy'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0457447', 'cui_str': 'Pull-through technique (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",20.0,0.0378695,Both groups had similar responses to BEQ scores before and after the surgery with no statistically significant difference.,"[{'ForeName': 'Satyaswarup', 'Initials': 'S', 'LastName': 'Tripathy', 'Affiliation': 'Department of Plastic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Likhyani', 'Affiliation': 'Department of Plastic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Plastic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India. dr.sharma.raman@gmail.com.'}, {'ForeName': 'Ramesh Kumar', 'Initials': 'RK', 'LastName': 'Sharma', 'Affiliation': 'Department of Plastic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01618-0']
3280,31535560,The influence of religious beliefs and practices on health care decision-making among HIV positive adolescents.,"It is unknown if religiousness/spirituality influences end-of-life treatment preferences among adolescents. Investigators assessed whether religiousness/spirituality moderates the relationship between an advance care planning intervention and end-of-life treatment preferences among 85 primarily African-American adolescents living with HIV/AIDS in outpatient-hospital-based HIV-specialty clinics in the United States. Adolescents aged 14-21 years living with HIV/AIDS and their families were randomized to three-weekly-60-minute sessions either: advance care planning (survey, goals of care conversation, advance directive); or control (developmental history, safety tips, nutrition/exercise). At 3-months post-intervention the intervention effect ( decreasing  the likelihood of choosing to continue treatments in  all situations ) was significantly moderated by religiousness/spirituality. Highly religious/spiritual adolescents were four times more likely to choose to continue treatments in  all situations . Thus, intensive treatments at end-of-life may represent health equity, rather than health disparity. The belief believed that HIV is a punishment from God at baseline (15%, 14/94) was not associated with end-of-life treatment preferences. Twelve percent (11/94) reported they had stopped taking HIV medications for more than 3 days because of the belief in a miracle. Religiousness moderates adolescent's medical decision-making. Adolescents who believe in miracles should receive chaplaincy referrals to help maintain medication adherence.",2020,At 3-months post-intervention the intervention effect ( decreasing  the likelihood of choosing to continue treatments in  all situations ) was significantly moderated by religiousness/spirituality.,"['HIV positive adolescents', 'Adolescents aged 14-21 years living with HIV/AIDS and their families', '85 primarily African-American adolescents living with HIV/AIDS in outpatient-hospital-based HIV-specialty clinics in the United States', 'adolescents']","['advance care planning (survey, goals of care conversation, advance directive); or control (developmental history, safety tips, nutrition/exercise']",['stopped taking HIV medications'],"[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",85.0,0.0456278,At 3-months post-intervention the intervention effect ( decreasing  the likelihood of choosing to continue treatments in  all situations ) was significantly moderated by religiousness/spirituality.,"[{'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Washington, DC, USA.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': ""D'Angelo"", 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Washington, DC, USA.""}, {'ForeName': 'Yao I', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Science/Children's Research Institute, Children's National, Washington, DC, USA.""}, {'ForeName': 'Ronald H', 'Initials': 'RH', 'LastName': 'Dallas', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Garvie', 'Affiliation': ""Research Department, Children's Diagnostic & Treatment Center, Fort Lauderdale, FL, USA.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Science/Children's Research Institute, Children's National, Washington, DC, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Washington, DC, USA.""}]",AIDS care,['10.1080/09540121.2019.1668523']
3281,32049269,Effect of Reduced Exposure to Vasopressors on 90-Day Mortality in Older Critically Ill Patients With Vasodilatory Hypotension: A Randomized Clinical Trial.,"Importance


Vasopressors are commonly administered to intensive care unit (ICU) patients to raise blood pressure. Balancing risks and benefits of vasopressors is a challenge, particularly in older patients.
Objective


To determine whether reducing exposure to vasopressors through permissive hypotension (mean arterial pressure [MAP] target, 60-65 mm Hg) reduces mortality at 90 days in ICU patients aged 65 years or older with vasodilatory hypotension.
Design, Setting, and Participants


A multicenter, pragmatic, randomized clinical trial was conducted in 65 ICUs in the United Kingdom and included 2600 randomized patients aged 65 years or older with vasodilatory hypotension (assessed by treating clinician). The study was conducted from July 2017 to March 2019, and follow-up was completed in August 2019.
Interventions


Patients were randomized 1:1 to vasopressors guided either by MAP target (60-65 mm Hg, permissive hypotension) (n = 1291) or according to usual care (at the discretion of treating clinicians) (n = 1307).
Main Outcome and Measures


The primary clinical outcome was all-cause mortality at 90 days.
Results


Of 2600 randomized patients, after removal of those who declined or had withdrawn consent, 2463 (95%) were included in the analysis of the primary outcome (mean [SD] age 75 years [7 years]; 1387 [57%] men). Patients randomized to the permissive hypotension group had lower exposure to vasopressors compared with those in the usual care group (median duration 33 hours vs 38 hours; difference in medians, -5.0; 95% CI, -7.8 to -2.2 hours; total dose in norepinephrine equivalents median, 17.7 mg vs 26.4 mg; difference in medians, -8.7 mg; 95% CI, -12.8 to -4.6 mg). At 90 days, 500 of 1221 (41.0%) in the permissive hypotension compared with 544 of 1242 (43.8%) in the usual care group had died (absolute risk difference, -2.85%; 95% CI, -6.75 to 1.05; P = .15) (unadjusted relative risk, 0.93; 95% CI, 0.85-1.03). When adjusted for prespecified baseline variables, the odds ratio for 90-day mortality was 0.82 (95% CI, 0.68 to 0.98). Serious adverse events were reported for 79 patients (6.2%) in the permissive care group and 75 patients (5.8%) in the usual care group. The most common serious adverse events were acute renal failure (41 [3.2%] vs 33 [2.5%]) and supraventricular cardiac arrhythmia (12 [0.9%] vs 13 [1.0%]).
Conclusions and Relevance


Among patients 65 years or older receiving vasopressors for vasodilatory hypotension, permissive hypotension compared with usual care did not result in a statistically significant reduction in mortality at 90 days. However, the confidence interval around the point estimate for the primary outcome should be considered when interpreting the clinical importance of the study.
Trial Registration


isrctn.org Identifier: ISRCTN10580502.",2020,Serious adverse events were reported for 79 patients (6.2%) in the permissive care group and 75 patients (5.8%) in the usual care group.,"['July 2017 to March 2019, and follow-up was completed in August 2019', 'ICU patients aged 65 years or older with vasodilatory hypotension', 'patients 65 years or older receiving vasopressors for vasodilatory hypotension, permissive hypotension', '2600 randomized patients, after removal of those who declined or had withdrawn consent, 2463 (95%) were included in the analysis of the primary outcome (mean [SD] age 75 years [7 years]; 1387 [57%] men', '65 ICUs in the United Kingdom and included 2600 randomized patients aged 65 years or older with vasodilatory hypotension (assessed by treating clinician', 'older patients', 'Older Critically Ill Patients With Vasodilatory Hypotension']","['vasopressors guided either by MAP target (60-65 mm Hg, permissive hypotension) (n\u2009=\u20091291) or according to usual care (at the discretion of treating clinicians', 'Reduced Exposure to Vasopressors', 'permissive hypotension']","['lower exposure to vasopressors', 'mortality', 'odds ratio for 90-day mortality', 'acute renal failure', 'cause mortality', 'supraventricular cardiac arrhythmia', 'permissive hypotension', 'Serious adverse events', '90-Day Mortality']","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3645573', 'cui_str': 'Map target'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1869051', 'cui_str': 'Cardiac arrhythmias (SMQ)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2600.0,0.284356,Serious adverse events were reported for 79 patients (6.2%) in the permissive care group and 75 patients (5.8%) in the usual care group.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Richards-Belle', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'M Zia', 'Initials': 'MZ', 'LastName': 'Sadique', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Health Services Research and Policy, London, United Kingdom.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Grieve', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Health Services Research and Policy, London, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Camsooksai', 'Affiliation': 'Critical Care, Poole Hospital NHS Foundation Trust, Poole, Dorset, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Darnell', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Henry', 'Affiliation': 'Patient representative, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hudson', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Alexina J', 'Initials': 'AJ', 'LastName': 'Mason', 'Affiliation': 'London School of Hygiene and Tropical Medicine, Department of Health Services Research and Policy, London, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Saull', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Whitman', 'Affiliation': 'Patient representative, United Kingdom.'}, {'ForeName': 'J Duncan', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Kadoorie Centre for Critical Care Research and Education, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.0930']
3282,32053911,Storytelling in Medical Education: Narrative Medicine as a Resource for Interdisciplinary Collaboration.,"Objective:  The study intended to use narrative medicine study for interdisciplinary collaboration to let medical and healthcare students have a chance to interact with one another and listen to patients' stories to enhance students' reflective thinking, communication, empathy, and narrative medicine writing skills.  Methods:  A fifteen-week quasi-experimental design was used to examine the learning outcomes of the intervention. Two groups of students were randomly assigned as the experimental group (33 students) and the control group (32 students). Before and after the intervention, both groups had to fill in a Reflective Thinking Scale for Healthcare Students and Providers (RTS-HSP), Patient-Healthcare Provider Communication Scale (P-HCS), Empathy Scale in Patient Care (ES-PC), and Analytic Narrative Medicine Writing Scoring Rubric (ANMWSR). Results: The findings showed that on the reflective thinking scale, experimental group students had significantly higher reflective thinking posttest scores in ""reflective skepticism,"" ""empathetic reflection,"" and ""critical open-mindedness,"" but not in ""self-examination."" As for patient-healthcare provider communication, they had significantly higher posttest scores in all ""perception of trust and receptivity,"" ""patient-centered information giving,"" ""rapport building,"" and ""facilitation of patient involvement"" factors. As for empathy, they had significant higher posttest scores in ""behavioral empathy"" and ""affective empathy,"" but not in ""intelligent empathy."" In narrative medical writing skills, they had significant higher posttest scores in the ""attention → representation → affiliation,"" ""depth of reflection,"" ""focus and context structure,"" and ""ideas and elaboration"" sections, but not in the ""language and conventions"" section.  Conclusion:  The findings suggest that narrative medicine is worth recommending for interdisciplinary collaboration for healthcare education.",2020,"As for patient-healthcare provider communication, they had significantly higher posttest scores in all ""perception of trust and receptivity,"" ""patient-centered information giving,"" ""rapport building,"" and ""facilitation of patient involvement"" factors.",['Two groups of students were randomly assigned as the experimental group (33 students) and the control group (32 students'],[],"['behavioral empathy"" and ""affective empathy,"" but not in ""intelligent empathy', 'Writing Scoring Rubric (ANMWSR', 'reflective thinking posttest scores in ""reflective skepticism,"" ""empathetic reflection,"" and ""critical open-mindedness,"" but not in ""self-examination', 'Reflective Thinking Scale for Healthcare Students and Providers (RTS-HSP), Patient-Healthcare Provider Communication Scale (P-HCS), Empathy Scale in Patient Care']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0080142', 'cui_str': 'Self-Examination'}, {'cui': 'C0222045'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0017313'}]",,0.0238611,"As for patient-healthcare provider communication, they had significantly higher posttest scores in all ""perception of trust and receptivity,"" ""patient-centered information giving,"" ""rapport building,"" and ""facilitation of patient involvement"" factors.","[{'ForeName': 'Hung-Chang', 'Initials': 'HC', 'LastName': 'Liao', 'Affiliation': 'Department of Health Services Administration, Chung Shan Medical University, Taichung 402, Taiwan.'}, {'ForeName': 'Ya-Huei', 'Initials': 'YH', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Education, Chung Shan Medical University Hospital, Taichung 402, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17041135']
3283,32053942,Supplementation with a Bioactive Melon Concentrate in Humans and Animals: Prevention of Oxidative Damages and Fatigue in the Context of a Moderate or Eccentric Physical Activity.,"Exercise is recognized to provide both physical and psychological health benefits. However, oxidative stress can occur and induce muscular damages. SOD B® M is a melon concentrate, well known to counteract oxidative stress and prevent its side effects. The present study aimed to evaluate the potential of the melon concentrate in the context of both a strong and isolated effort associated with deleterious effects, and a moderate and regular physical activity considered as beneficial. First, a preclinical study was set up on rats to evaluate its potential on the prevention of damages induced by an eccentric exercise. Secondly, the combined effect of the melon concentrate and a regular standardized physical training was studied on the overall physical condition of healthy subjects in a randomized, double-blind, placebo-controlled trial. Repeated measures Analysis of Variance (ANOVA), student's t test and Mann-Whitney test were used for statistical analyses. Melon concentrate helped to prevent gastrocnemius damages induced by the eccentric exercise. It allowed a reduction of fibrosis by approximately 38% and a reduction of Tumor Necrosis Factor- α (TNF-α) plasma level by 28%. This supplementation also induced a rearrangement of myosin fibers and an increase in PGC-1α plasma level. In the clinical study, melon concentrate was able to decrease oxidative stress and C-Reactive protein (CRP) plasma level. Besides, magnesium (Mg) plasma level was higher in the context of a regular training performed by healthy subjects supplemented with the melon concentrate. Therefore, the melon concentrate allowed a better adaptation to effort linked to PGC-1α activation: a regulator of energy metabolism. The antioxidant properties of the melon concentrate and its ability to mobilize magnesium also suggest that the supplementation could induce a better resistance to fatigue and recovery during regular physical activity.",2020,"In the clinical study, melon concentrate was able to decrease oxidative stress and C-Reactive protein (CRP) plasma level.","['Humans and Animals', 'healthy subjects']","['melon concentrate and a regular standardized physical training', 'placebo', 'α', 'Bioactive Melon Concentrate', 'SOD B®']","['PGC-1α plasma level', 'oxidative stress and C-Reactive protein (CRP) plasma level', 'Tumor Necrosis Factor', 'TNF-α) plasma level', 'magnesium (Mg) plasma level']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0440285', 'cui_str': 'Melons'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]",,0.0486878,"In the clinical study, melon concentrate was able to decrease oxidative stress and C-Reactive protein (CRP) plasma level.","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Saby', 'Affiliation': 'EA7288 UFR Pharmacie, Université de Montpellier, CEDEX 5, 34093 Montpellier, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Gauthier', 'Affiliation': 'Bionov Research, 939 rue de la croix verte, 34090 Montpellier, France.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Barial', 'Affiliation': 'EA7288 UFR Pharmacie, Université de Montpellier, CEDEX 5, 34093 Montpellier, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Egoumenides', 'Affiliation': 'Bionov Research, 939 rue de la croix verte, 34090 Montpellier, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Jover', 'Affiliation': 'PhyMedExp, INSERM CNRS, Université de Montpellier, IURC, CEDEX 5, 34295 Montpellier, France.'}]",International journal of environmental research and public health,['10.3390/ijerph17041142']
3284,31349017,Cathodal stimulating the left DLPFC changes risk disposition toward common risky behaviors in daily-life.,"Many daily activities require the weighting of risks and gains, and adjusting decisions based on this information. The present study investigates the role of left DLPFC in such normal-life, routine, but risky decisions. We expected that down-regulating the left DLPFC will reduce emphasis on gains such that less-riskier decisions, as captured with attitude and behavioral intention measures, are made. In study 1 (n = 56), tDCS naïve participants were recruited and subjected to high-definition cathodal tDCS stimulation (with intensity of 1.5 mA for 20 min) of the left DLPFC. A single-blind within-subject pre-post design was employed, in which each subject responded to realistic, normal life, risky decision and control scenarios, before and after stimulation. In study 2 (n = 60), we added a between-subjects factor by assigning half of the participants to a sham stimulation condition. Results were consistent across studies. They demonstrated significantly reduced attitudes and intentions toward risky behaviors, and no significant changes in attitudes and intentions toward control behaviors. Study 2 showed that the reductions were significantly larger in the tDCS stimulation group than in the sham group. These results highlight the role of the left DLPFC in mediating common daily risky behaviors.",2019,"They demonstrated significantly reduced attitudes and intentions toward risky behaviors, and no significant changes in attitudes and intentions toward control behaviors.","['In study 1 (n\u202f=\u202f56), tDCS naïve participants were recruited and subjected to high-definition cathodal tDCS stimulation (with intensity of 1.5\u202fmA for 20\u202fmin) of the left DLPFC']",[],"['attitudes and intentions toward risky behaviors', 'attitudes and intentions toward control behaviors']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0522510', 'cui_str': 'With intensity (attribute)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",[],"[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1831579', 'cui_str': 'Controlling behavior'}]",,0.0260725,"They demonstrated significantly reduced attitudes and intentions toward risky behaviors, and no significant changes in attitudes and intentions toward control behaviors.","[{'ForeName': 'Yatong', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Turel', 'Affiliation': 'Information Systems and Decision Sciences, California State University, Fullerton, CA, USA; Brain and Creativity Institute, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Youqing', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Chenyu', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing, China; Brain and Creativity Institute, University of Southern California, Los Angeles, USA; Key Laboratory of Cognition and Personality, Ministry of Education, Southwest University, Chongqing, China; Chongqing Collaborative Innovation Center for Brain Science, Chongqing, China; Southwest University Branch, Collaborative Innovation Center of Assessment toward Basic Education Quality at Beijing Normal University, Chongqing, China. Electronic address: heqinghua@swu.edu.cn.'}]",Neuroscience letters,['10.1016/j.neulet.2019.134400']
3285,31977836,"Combined Sprint Interval, Plyometric, and Strength Training in Adolescent Soccer Players: Effects on Measures of Speed, Strength, Power, Change of Direction, and Anaerobic Capacity.","Ferley, DD, Scholten, S, and Vukovich, MD. Combined sprint interval, plyometric, and strength training in adolescent soccer players: effects on measures of speed, strength, power, change of direction, and anaerobic capacity. J Strength Cond Res 34(4): 957-968, 2020-During winter, many soccer players train indoors to improve the aerobic and anaerobic demands of their sport. Sprint interval training (SIT) performed on a treadmill using level and graded conditions represents a viable alternative to traditional endurance conditioning. To date, little research exists contrasting the effects of these conditions. Therefore, the purpose of this investigation included examining the effects of 2 approaches combining SIT, plyometrics, and strength training on performance measures in soccer players aged 13-18 years over 8 weeks. Forty-six subjects were divided into 3 groups. Group 1 performed SIT using predominantly inclined treadmill conditions combined with resistance and plyometric training (INC, n = 17). Group 2 performed SIT using level treadmill grades and completed the same resistance and plyometric training (LEV, n = 14). Group 3 was a control group representing various sports who continued their normal training (CON, n = 15). Pre- and posttests assessed speed, strength, change of direction, and anaerobic capacity, including sprint speed (9.1 and 18.3 m sprint), unilateral triple hop for distance (3HOP_L and 3HOP_R), pro agility change of direction (PA); treadmill running to exhaustion on a 20% grade (CFMod), and hip flexor maximum strength (HF_1RM). After training, INC and LEV improved more in all measures compared with CON. Furthermore, INC improved significantly more compared with LEV in 9.1- and 18.3-m sprint, 3HOP_L and 3HOP_R, PA, CFMod, and HF_1RM (p < 0.05). We conclude that strength and plyometric training combined with incline-based SIT is more effective than a similar training approach using level-grade SIT.",2020,"After training, INC and LEV improved more in all measures compared with CON.","['Adolescent Soccer Players', 'soccer players aged 13-18 years over 8 weeks', 'adolescent soccer players', 'Forty-six subjects']","['strength training', 'SIT using predominantly inclined treadmill conditions combined with resistance and plyometric training', 'Sprint interval training (SIT) performed on a treadmill using level and graded conditions represents a viable alternative to traditional endurance conditioning', 'J Strength Cond Res XX(X', 'Combined Sprint Interval, Plyometric, and Strength Training', 'strength and plyometric training combined with incline-based SIT', 'Combined sprint interval, plyometric, and strength training', 'CON', 'control group representing various sports who continued their normal training']","['speed, strength, power, change of direction, and anaerobic capacity', 'Ferley, DD, Scholten, S, and Vukovich, MD', 'speed, strength, change of direction, and anaerobic capacity, including sprint speed (9.1 and 18.3 m sprint), unilateral triple hop for distance (3HOP_L and 3HOP_R), pro agility change of direction (PA); treadmill running to exhaustion on a 20% grade (CFMod), and hip flexor maximum strength (HF_1RM', 'Speed, Strength, Power, Change of Direction, and Anaerobic Capacity', '3HOP_L and 3HOP_R, PA, CFMod, and HF_1RM']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]",46.0,0.0125243,"After training, INC and LEV improved more in all measures compared with CON.","[{'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Ferley', 'Affiliation': 'Avera McKennan Hospital and University Health Center, Avera Sports Institute, Sioux Falls, South Dakota.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Scholten', 'Affiliation': 'Augustana University, Department of Exercise and Sport Sciences, Sioux Falls, South Dakota.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Vukovich', 'Affiliation': 'College of Education and Human Sciences, South Dakota State University, Brookings, South Dakota.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003476']
3286,30248280,Socioeconomic differences in access to care in Australia for women fearful of birth.,"Objective Fear of childbirth is known to increase a woman's likelihood of having a Caesarean section. Continuity of midwifery care is known to reduce this risk, but less than 8% of women have access to this relationship-based, primary care model. The aims of this study were to determine whether healthcare use and access to continuity models are equal across different indicators of socioeconomic status for women who are fearful of birth. Methods A secondary analysis was conducted of data obtained during a randomised controlled trial of a psychoeducation intervention by trained midwives to minimise childbirth fear (the Birth Emotions and Looking to Improve Expectant Fear (BELIEF) study). In all, 1410 women were screened, with 339 women reporting high levels of fear (Wijma-Delivery Expectancy/Experience Questionnaire ≥66). Demographic, obstetric information, birth preference and psychosocial measures were collected at recruitment and at 36 weeks gestation for the 339 fearful women, with the birth method and health service use returned by 183 women at 6 weeks after the birth. Results Univariate analysis revealed no significant difference in the number of general practitioner and midwife visits between women of high and low income and high and low education. However, women with higher levels of education had 2.51-fold greater odds of seeing the same midwife throughout their pregnancy than women with lower education (95% confidence interval 1.25-5.04), after adjusting for age, parity and hospital site. Conclusions Given the known positive outcomes of continuity of midwifery care for women fearful of birth, health policy makers need to provide equity in access to evidence-based models of midwifery care. What is known about this topic? Caseload midwifery care is considered the gold standard care due to the known positive outcomes it has for the mother and baby during the perinatal period. Pregnant women who receive caseload midwifery care are more likely to experience a normal vaginal birth. What does this paper add? There is unequal access to midwifery caseload care for women fearful of birth across socioeconomic boundaries. Midwifery caseload care is not used for all fearful mothers during the perinatal period. What are the implications for practitioners? Health policy makers seeking to provide equity in access to maternity care should be aware of these inequalities in use to target delivery of care at this specific cohort of mothers.",2019,Results  Univariate analysis revealed no significant difference in the number of general practitioner and midwife visits between women of high and low income and high and low education.,"['1410 women were screened, with 339 women reporting high levels of fear (Wijma-Delivery Expectancy/Experience Questionnaire ≥66', 'women fearful of birth', '339 fearful women, with the birth method and health service use returned by 183 women at 6 weeks after the birth', 'women who are fearful of birth', 'Pregnant women who receive caseload midwifery care are more likely to experience a normal vaginal birth']",['psychoeducation intervention'],"['number of general practitioner and midwife visits', 'Demographic, obstetric information, birth preference and psychosocial measures']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",1410.0,0.113099,Results  Univariate analysis revealed no significant difference in the number of general practitioner and midwife visits between women of high and low income and high and low education.,"[{'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Toohill', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, 68 University Dr, Meadowbrook, Qld 4131, Australia. Email: ;'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Callander', 'Affiliation': 'Australian Institute of Tropical Health and Medicine, James Cook University, Building 48, Douglas Campus, Townsville, Qld 4811, Australia. Email:.'}, {'ForeName': 'Haylee', 'Initials': 'H', 'LastName': 'Fox', 'Affiliation': 'Australian Institute of Tropical Health and Medicine, James Cook University, Building 48, Douglas Campus, Townsville, Qld 4811, Australia. Email:.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lindsay', 'Affiliation': 'Australian Institute of Tropical Health and Medicine, James Cook University, Building 48, Douglas Campus, Townsville, Qld 4811, Australia. Email:.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gamble', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, 68 University Dr, Meadowbrook, Qld 4131, Australia. Email: ;'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Creedy', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, 68 University Dr, Meadowbrook, Qld 4131, Australia. Email: ;'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fenwick', 'Affiliation': 'School of Nursing and Midwifery, Griffith University, 68 University Dr, Meadowbrook, Qld 4131, Australia. Email: ;'}]",Australian health review : a publication of the Australian Hospital Association,['10.1071/AH17271']
3287,32096120,Burst Suppression: Causes and Effects on Mortality in Critical Illness.,"BACKGROUND


Burst suppression in mechanically ventilated intensive care unit (ICU) patients is associated with increased mortality. However, the relative contributions of propofol use and critical illness itself to burst suppression; of burst suppression, propofol, and critical illness to mortality; and whether preventing burst suppression might reduce mortality, have not been quantified.
METHODS


The dataset contains 471 adults from seven ICUs, after excluding anoxic encephalopathy due to cardiac arrest or intentional burst suppression for therapeutic reasons. We used multiple prediction and causal inference methods to estimate the effects connecting burst suppression, propofol, critical illness, and in-hospital mortality in an observational retrospective study. We also estimated the effects mediated by burst suppression. Sensitivity analysis was used to assess for unmeasured confounding.
RESULTS


The expected outcomes in a ""counterfactual"" randomized controlled trial (cRCT) that assigned patients to mild versus severe illness are expected to show a difference in burst suppression burden of 39%, 95% CI [8-66]%, and in mortality of 35% [29-41]%. Assigning patients to maximal (100%) burst suppression burden is expected to increase mortality by 12% [7-17]% compared to 0% burden. Burst suppression mediates 10% [2-21]% of the effect of critical illness on mortality. A high cumulative propofol dose (1316 mg/kg) is expected to increase burst suppression burden by 6% [0.8-12]% compared to a low dose (284 mg/kg). Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
CONCLUSIONS


Our analysis clarifies how important factors contribute to mortality in ICU patients. Burst suppression appears to contribute to mortality but is primarily an effect of critical illness rather than iatrogenic use of propofol.",2020,"Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
","['471 adults from seven ICUs, after excluding anoxic encephalopathy due to cardiac arrest or intentional burst suppression for therapeutic reasons', 'mechanically ventilated intensive care unit (ICU) patients', 'ICU patients']","['propofol', 'Propofol']","['burst suppression burden', 'mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0003132', 'cui_str': 'Anoxic Encephalopathy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0429306', 'cui_str': 'Burst suppression (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0429306', 'cui_str': 'Burst suppression (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0609599,"Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Haoqi', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Aboul Nour', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Tabaeizadeh', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Maryum', 'Initials': 'M', 'LastName': 'Shoukat', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Farrukh', 'Initials': 'F', 'LastName': 'Javed', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Kassa', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Muhammad M', 'Initials': 'MM', 'LastName': 'Edhi', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Bordbar', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Valdery Moura', 'Initials': 'VM', 'LastName': 'Junior', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Ghanta', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Shao', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Akeju', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cole', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Zafar', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'M Brandon', 'Initials': 'MB', 'LastName': 'Westover', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA. mwestover@mgh.harvard.edu.'}]",Neurocritical care,['10.1007/s12028-020-00932-4']
3288,32112909,Re- and demineralization characteristics of dentin depending on fluoride application and baseline characteristics in situ.,"OBJECTIVES


The aim of this double-blinded, randomized, cross-over in situ study was to evaluate the re- and demineralization characteristics of sound dentin as well as highly and lowly demineralized dentin after the application of different fluoride concentrations.
METHODS


In each of four experimental legs of four weeks 20 participants wore intraoral mandibular appliances containing two (highly demineralized [E H ]) bovine enamel and four (lowly and highly demineralized [D L ,D H ]) bovine dentin specimens (n = 480). Each specimen included one sound (ST) and one demineralized lesion area (DT). The four randomly allocated treatments included the following dentifrices: fluoride-free, zinc-carbonate-nano-hydroxyapatite [nHA 0 ], 0 ppm F -  [negative control,NaF 0 ], 1100 ppm F -  as NaF [standard therapy,NaF 1100 ] and 5000 ppm F -  as NaF [positive control,NaF 5000 ]. Differences in integrated mineral loss (ΔΔZ) and lesion depth (ΔLD) were calculated between values before and after the in situ period using transversal microradiography.
RESULTS


After the in situ period specimens of nHA 0  and NaF 0  showed signs of demineralization, indicated by significantly lower ΔZ&LD values for E H  and D L  (only nHA 0 )(p ≤ 0.028), whereas specimens of NaF 1100  and NaF 5000  showed signs of remineralization, indicated by significantly higher ΔZ values for E H  (only NaF 5000 ), D L  and D H  (p ≤ 0.012). The correlation between ΔΔZ DT /ΔΔZ ST  and F -  was moderate for E H (r DT  = 0.497;r ST  = 0.463) and D L (r DT  = 0.575;r ST  = 0.598) and strong for D H (r DH  = 0.700;r ST  = 0.611)(p < 0.001). No significant differences for ΔΔZ DT /ΔΔZ ST  were observed between nHA 0  and NaF 0 (p ≥ 0.333;ANCOVA).
CONCLUSION


The present in situ model was capable to reveal a fluoride dose-response on sound, lowly and highly demineralized dentin and also enamel specimens. Furthermore, both fluoride-free dentifrices, one containing nanohydroxyapatite, did not hamper demineralization.
CLINICAL SIGNIFICANCE


The present in situ model was capable to reveal a fluoride dose-response on dentin similar to the anticipated clinical efficacy. Highly demineralized specimens seem to be recommendable for measuring anti-caries effects on dentin in situ. Furthermore both fluoride-free dentifrices, one containing nanohydroxyapatite, did not hamper demineralization. The study was registered in the German Clinical Trials Register (DRKS-ID: DRKS00011653).",2020,"Furthermore both fluoride-free dentifrices, one containing nanohydroxyapatite, did not hamper demineralization.",[],"['dentifrices: fluoride-free, zinc-carbonate-nano-hydroxyapatite [nHA 0 ], 0\u2009ppm F- [negative control,NaF 0 ], 1100\u2009ppm F- as NaF [standard therapy,NaF 1100 ] and 5000\u2009ppm', 'intraoral mandibular appliances containing two (highly demineralized [E H ]) bovine enamel and four (lowly and highly demineralized [D L ,D H ]) bovine dentin specimens']","['signs of demineralization', 'integrated mineral loss (ΔΔZ) and lesion depth (ΔLD', 'ΔZ&LD values for E H  and D L', 'signs of remineralization']",[],"[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0078772', 'cui_str': 'zinc carbonate'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517537', 'cui_str': 'One thousand one hundred'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach (qualifier value)'}, {'cui': 'C0243112'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0231971', 'cui_str': 'Diffusion capacity of lung'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}]","[{'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0700185', 'cui_str': 'Demineralized structure'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231971', 'cui_str': 'Diffusion capacity of lung'}]",,0.0620591,"Furthermore both fluoride-free dentifrices, one containing nanohydroxyapatite, did not hamper demineralization.","[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Wierichs', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, School of Dental Medicine, University of Bern, 3010 Bern, Switzerland; Department of Biohybrid & Medical Textiles, Institute of Applied Medical Engineering, RWTH Aachen University, 52074 Aachen, Germany. Electronic address: richard.wierichs@zmk.unibe.ch.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Musiol', 'Affiliation': 'Department of Operative Dentistry, Periodontology and Preventive Dentistry, RWTH Aachen University, Pauwelsstr. 30, 52074 Aachen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Erdwey', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Medical Faculty, RWTH Aachen University, 52074 Aachen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Esteves-Oliveira', 'Affiliation': 'Department of Operative Dentistry, Periodontology and Preventive Dentistry, RWTH Aachen University, Pauwelsstr. 30, 52074 Aachen, Germany; Department of Cariology, Endodontology and Periodontology, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Apel', 'Affiliation': 'Department of Biohybrid & Medical Textiles, Institute of Applied Medical Engineering, RWTH Aachen University, 52074 Aachen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Meyer-Lueckel', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, School of Dental Medicine, University of Bern, 3010 Bern, Switzerland.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103305']
3289,31998949,"Surface Perturbation Training to Prevent Falls in Older Adults: A Highly Pragmatic, Randomized Controlled Trial.","BACKGROUND


Falls are the leading cause of injuries among older adults, and trips and slips are major contributors to falls.
OBJECTIVE


The authors sought to compare the effectiveness of adding a component of surface perturbation training to usual gait/balance training for reducing falls and fall-related injury in high-risk older adults referred to physical therapy.
DESIGN


This was a multi-center, pragmatic, randomized, comparative effectiveness trial.
SETTING


Treatment took place within 8 outpatient physical therapy clinics.
PATIENTS


This study included 506 patients 65+ years of age at high fall risk referred for gait/balance training.
INTERVENTION


This trial evaluated surface perturbation treadmill training integrated into usual multimodal exercise-based balance training at the therapist's discretion versus usual multimodal exercise-based balance training alone.
MEASUREMENTS


Falls and injurious falls were assessed with a prospective daily fall diary, which was reviewed via telephone interview every 3 months for 1 year.A total of 211/253 (83%) patients randomized to perturbation training and 210/253 (83%) randomized to usual treatment provided data at 3-month follow-up. At 3 months, the perturbation training group had a significantly reduced chance of fall-related injury (5.7% versus 13.3%; relative risk 0.43) but no significant reduction in the risk of any fall (28% versus 37%, relative risk 0.78) compared with usual treatment. Time to first injurious fall showed reduced hazard in the first 3 months but no significant reduction when viewed over the entire first year.
LIMITATIONS


The limitations of this trial included lack of blinding and variable application of interventions across patients based on pragmatic study design.
CONCLUSION


The addition of some surface perturbation training to usual physical therapy significantly reduced injurious falls up to 3 months posttreatment. Further study is warranted to determine the optimal frequency, dose, progression, and duration of surface perturbation aimed at training postural responses for this population.",2020,"At 3 months, the perturbation-training group had significantly reduced chance of fall-related injury (5.7% vs. 13.3%; relative risk 0.43, p < 0.01) but no significant reduction in the risk of any fall (28% vs. 37% ST; relative risk 0.78 p<0.07) compared to usual treatment.","['high-risk older adults', 'Older Adults', 'Treatment took place within 8 outpatient physical therapy clinics', '506 patients aged 65+ at high fall risk referred for gait/balance training']","['surface-perturbation training to usual gait/balance training', 'Surface Perturbation Training', ""usual multimodal exercise-based balance training at the therapist's discretion versus usual multimodal exercise-based balance training alone""]","['injurious falls', 'Falls and injurious falls', 'chance of fall-related injury']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",506.0,0.0271618,"At 3 months, the perturbation-training group had significantly reduced chance of fall-related injury (5.7% vs. 13.3%; relative risk 0.43, p < 0.01) but no significant reduction in the risk of any fall (28% vs. 37% ST; relative risk 0.78 p<0.07) compared to usual treatment.","[{'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Lurie', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03781 (USA), and Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Zagaria', 'Affiliation': 'Geisel School of Medicine at Dartmouth.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Elliot Hospital Senior Health Center Rehabilitation, Manchester, New Hampshire.'}, {'ForeName': 'Dawna', 'Initials': 'D', 'LastName': 'Pidgeon', 'Affiliation': 'Dartmouth-Hitchcock Medical Center.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Gill-Body', 'Affiliation': 'Newton-Wellesley Hospital, Newton, Massachusetts. Dr Gill-Body is a board-certified clinical specialist in neurologic physical therapy.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Burke', 'Affiliation': 'South Shore Neurologic Associates, Patchogue, New York. Dr Burke is a board-certified clinical specialist in neurologic physical therapy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Armbrust', 'Affiliation': 'White River Junction Veterans Administration Hospital, White River Junction, Vermont.'}, {'ForeName': 'Sharil', 'Initials': 'S', 'LastName': 'Cass', 'Affiliation': 'Farnum Rehabilitation Center, Keene, New Hampshire.'}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Spratt', 'Affiliation': 'Geisel School of Medicine at Dartmouth.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'McDonough', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Physical therapy,['10.1093/ptj/pzaa023']
3290,32014843,Effectiveness of a Web-Based Menu-Planning Intervention to Improve Childcare Service Compliance With Dietary Guidelines: Randomized Controlled Trial.,"BACKGROUND


Foods provided in childcare services are not consistent with dietary guideline recommendations. Web-based systems offer unique opportunities to support the implementation of such guidelines.
OBJECTIVE


This study aimed to assess the effectiveness of a Web-based menu planning intervention in increasing the mean number of food groups on childcare service menus that comply with dietary guidelines. Secondary aims were to assess the impact of the intervention on the proportion of service menus compliant with recommendations for (1) all food groups; (2) individual food groups; and (3) mean servings of individual food groups. Childcare service use and acceptability of the Web-based program were also assessed.
METHODS


A single-blind, parallel-group randomized controlled trial was undertaken with 54 childcare services in New South Wales, Australia. Services were randomized to a 12-month intervention or usual care control. Intervention services received access to a Web-based menu planning program linked to their usual childcare management software system. Childcare service compliance with dietary guidelines and servings of food groups were assessed at baseline, 3-month follow-up, and 12-month follow-up.
RESULTS


No significant differences in the mean number of food groups compliant with dietary guidelines and the proportion of service menus compliant with recommendations for all food groups, or for individual food groups, were found at 3- or 12-month follow-up between the intervention and control groups. Intervention service menus provided significantly more servings of fruit (P<.001), vegetables (P=.03), dairy (P=.03), and meat (P=.003), and reduced their servings of discretionary foods (P=.02) compared with control group at 3 months. This difference was maintained for fruit (P=.03) and discretionary foods (P=.003) at 12 months. Intervention childcare service staff logged into the Web-based program an average of 40.4 (SD 31.8) times and rated the program as highly acceptable.
CONCLUSIONS


Although improvements in childcare service overall menu and individual food group compliance with dietary guidelines were not statistically significant, findings indicate that a Web-based menu planning intervention can improve the servings for some healthy food groups and reduce the provision of discretionary foods. Future research exploring the effectiveness of differing strategies in improving the implementation of dietary guidelines in childcare services is warranted.
TRIAL REGISTRATION


Australian New Zealand Clinical Trial Registry (ANZCTR): 16000974404; http://www.anzctr.org.au/ACTRN12616000974404.aspx.",2020,This difference was maintained for fruit (P=.03) and discretionary foods (P=.003) at 12 months.,"['54 childcare services in New South Wales, Australia', 'mean number of food groups on childcare service menus that comply with dietary guidelines']","['Web-based menu planning intervention', 'intervention or usual care control', 'access to a Web-based menu planning program linked to their usual childcare management software system', 'Web-Based Menu-Planning Intervention']","['servings of discretionary foods', 'servings of fruit (P<.001), vegetables']","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3658297', 'cui_str': 'Nutrition Guidelines'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]",,0.0686262,This difference was maintained for fruit (P=.03) and discretionary foods (P=.003) at 12 months.,"[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Grady', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Finch', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Flood', 'Affiliation': 'Westmead Hospital, Western Sydney Local Health District, Westmead, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Salajan', 'Affiliation': 'Healthy Australia Ltd, Melbourne, Australia.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': ""O'Rourke"", 'Affiliation': 'Healthy Australia Ltd, Melbourne, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stacey', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wyse', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Population Health, Hunter New England Local Health District, Wallsend, Australia.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Barnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Green', 'Affiliation': 'Population Health, Hunter New England Local Health District, Wallsend, Australia.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Herrmann', 'Affiliation': 'Population Health, Hunter New England Local Health District, Wallsend, Australia.'}, {'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}]",Journal of medical Internet research,['10.2196/13401']
3291,30957525,HIV Anxiety Reduction/Management Program (HAMRT): pilot randomized controlled trial.,"Research has indicated that mental health disorders, particularly anxiety, predicts poorer antiretroviral medication adherence among persons living with HIV/AIDS (PLWHA). The present study tests a novel six-session Cognitive-Behavioral Therapy-based integrated treatment/management program for PLWHA with concurrent anxiety delivered in community health clinics Houston, Texas. Twenty-Seven PLWHA ( M age     = 48.5, SD = 8.9, 44.4% female) were recruited for a proof-of-concept study and randomized to either an active treatment condition, or a waitlist control condition of equal length. Participants were assessed pre-randomization, at the mid-treatment time point (after three sessions for the active participants and three weeks for the control participants) and post-treatment (six sessions for active participants, six weeks for control participants). Data were examined used Bayesian multilevel models. Results indicated a reliable (99.87% posterior probability of a moderating effect) interaction between active and control groups for depressive symptoms and reliable (99.65% probability) interaction for anxiety symptoms. Results indicated an unreliable interaction for combined antiretroviral therapy adherence. These findings are discussed in terms of the feasibility and potential utility of administering an anxiety-reduction therapy program designed for PLWHA with HIV medication adherence difficulties.",2019,Results indicated a reliable (99.87% posterior probability of a moderating effect) interaction between active and control groups for depressive symptoms and reliable (99.65% probability) interaction for anxiety symptoms.,"['persons living with HIV/AIDS (PLWHA', 'Twenty-Seven PLWHA (M age  \u2009=\u200948.5, SD\u2009=\u20098.9, 44.4% female', 'with concurrent anxiety delivered in community health clinics Houston, Texas']","['HIV Anxiety Reduction/Management Program (HAMRT', 'novel six-session Cognitive-Behavioral Therapy-based integrated treatment/management program for PLWHA']",[],"[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0359709,Results indicated a reliable (99.87% posterior probability of a moderating effect) interaction between active and control groups for depressive symptoms and reliable (99.65% probability) interaction for anxiety symptoms.,"[{'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Brandt', 'Affiliation': 'Houston OCD Program , Houston , TX , USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Paulus', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina , Charleston , SC , USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Lopez-Gamundi', 'Affiliation': 'University of Texas Health Science Center at Houston , Houston , TX , USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'University of Texas Health Science Center at Houston , Houston , TX , USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Lemaire', 'Affiliation': 'Legacy Community Health , Houston , TX , USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston , Houston , TX , USA.'}]",AIDS care,['10.1080/09540121.2019.1597962']
3292,31234962,Recruiting people with HIV to an online self-management support randomised controlled trial: barriers and facilitators.,"Background Recruitment of people to randomised trials of online interventions presents particular challenges and opportunities. The aim of this study was to evaluate factors associated with the recruitment of people with HIV (PWHIV) and their doctors to the HealthMap trial, a cluster randomised trial of an online self-management program.
METHODS


Recruitment involved a three-step process. Study sites were recruited, followed by doctors caring for PWHIV at study sites and finally PWHIV. Data were collected from study sites, doctors and patient participants. Factors associated with site enrolment and patient participant recruitment were investigated using regression models.
RESULTS


Thirteen study sites, 63 doctor participants and 728 patient participants were recruited to the study. Doctors having a prior relationship with the study investigators (odds ratio (OR) 13.3; 95% confidence interval (CI) 3.0, 58.7; P = 0.001) was positively associated with becoming a HealthMap site. Most patient participants successfully recruited to HealthMap (80%) had heard about the study from their HIV doctor. Patient enrolment was associated with the number of people with HIV receiving care at the site (β coefficient 0.10; 95% CI 0.04, 0.16; P = 0.004), but not with employing a clinic or research nurse to help recruit patients (β coefficient 55.9; 95% CI -2.55, 114.25; P = 0.06).
CONCLUSION


Despite substantial investment in online promotion, a previous relationship with doctors was important for doctor recruitment, and doctors themselves were the most important source of patient recruitment to the HealthMap trial. Clinic-based recruitment strategies remain a critical component of trial recruitment, despite expanding opportunities to engage with online communities.",2019,"Patient enrolment was associated with the number of people with HIV receiving care at the site (β coefficient 0.10; 95% CI 0.04, 0.16; P = 0.004), but not with employing a clinic or research nurse to help recruit patients (β coefficient 55.9; 95% CI -2.55, 114.25; P = 0.06).  ","['Thirteen study sites, 63 doctor participants and 728 patient participants were recruited to the study', 'people with HIV (PWHIV) and their doctors to the HealthMap trial', 'Most patient participants successfully recruited to HealthMap (80%) had heard about the study from their HIV doctor', 'Study sites were recruited, followed by doctors caring for PWHIV at study sites and finally PWHIV']",['online interventions'],['number of people with HIV receiving care'],"[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",63.0,0.35086,"Patient enrolment was associated with the number of people with HIV receiving care at the site (β coefficient 0.10; 95% CI 0.04, 0.16; P = 0.004), but not with employing a clinic or research nurse to help recruit patients (β coefficient 55.9; 95% CI -2.55, 114.25; P = 0.06).  ","[{'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Klassen', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Vic. 3004, Australia; and Corresponding author. Email: karenklassen@gmail.com.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Millard', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Vic. 3004, Australia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Stout', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Vic. 3004, Australia.'}, {'ForeName': 'Karalyn', 'Initials': 'K', 'LastName': 'McDonald', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Vic. 3004, Australia.'}, {'ForeName': 'Sarity', 'Initials': 'S', 'LastName': 'Dodson', 'Affiliation': 'Health Systems Improvement Unit, Centre for Population Health Research, School of Health and Social Development, Deakin University, Geelong, Vic. 3125, Australia.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Osborne', 'Affiliation': 'Health Systems Improvement Unit, Centre for Population Health Research, School of Health and Social Development, Deakin University, Geelong, Vic. 3125, Australia.'}, {'ForeName': 'Malcolm W', 'Initials': 'MW', 'LastName': 'Battersby', 'Affiliation': 'Flinders Human Behaviour and Health Research Unit, Flinders University, Adelaide, SA 5001, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Fairley', 'Affiliation': 'Melbourne Sexual Health Centre and Department of Medicine, Central Clinical School, Monash University, Melbourne, Vic. 3000, Australia.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kidd', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto M5G 1V7, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McMahon', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Vic. 3004, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'East Sydney Doctors, 102 Burton Street, Darlinghurst, NSW 2010, Australia.'}, {'ForeName': 'Julian H', 'Initials': 'JH', 'LastName': 'Elliott', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Vic. 3004, Australia; and Cochrane Australia, School of Public Health and Preventative Medicine, Monash University, Melbourne, Vic. 3004, Australia.'}]",Sexual health,['10.1071/SH18130']
3293,31492475,Text message reminders to improve infant immunization in Guatemala: A randomized clinical trial.,"OBJECTIVE


Millions of infants worldwide remain under-immunized and at risk for unnecessary morbidity and mortality. Text messaging may offer a low-cost solution. We aimed to evaluate text message reminders to improve infant immunization in Guatemala.
METHODS


A randomized clinical trial was conducted at four public health clinics in rural and urban Guatemala. Infants ages six weeks to six months presenting for the first visit of the primary immunization series were randomly and equally allocated to an intervention or usual care group. Intervention participants were sent three text reminders before the second and third vaccine visits. The main outcome was timeliness of the second and third visits of the primary immunization series.
RESULTS


Of 1088 families approached for enrollment between March to November 2016, 871 were eligible and 720 (82.7%) participated; only 54 families did not own a cell phone. Due to country-wide vaccine shortages, visit completion was used as a proxy for overall immunization coverage. In intention to treat analysis, both intervention and usual care groups had high rates of visit completion, but intervention participants presented on the scheduled date more often (151 [42.2%] of 358 intervention vs. 111 [30.7%] of 362 usual care participants for visit 2, p = 0.001, and 112 [34.0%] of 329 intervention vs. 90 [27.0%] of 333 usual care participants for visit 3, p = 0.05). Intervention caregivers were significantly more likely to want to receive future text message reminders for vaccines and other appointments and were more willing to pay for these reminders.
CONCLUSION


Caregivers who were sent text message reminders in urban and rural Guatemala were less delayed for their child's immunization visits and reported high user satisfaction. Text message reminders may be an effective tool to increase infant vaccination coverage in low-income settings by reminding parents to vaccinate.
TRIAL REGISTRATION


NCT02567006 at clinicaltrials.gov.",2019,"CONCLUSION


Caregivers who were sent text message reminders in urban and rural Guatemala were less delayed for their child's immunization visits and reported high user satisfaction.","['infant immunization in Guatemala', 'Of 1088 families approached for enrollment between March to November 2016, 871 were eligible and 720 (82.7%) participated; only 54 families did not own a cell phone', 'four public health clinics in rural and urban Guatemala', 'Infants ages six weeks to six months presenting for the first visit of the primary immunization series']",['intervention or usual care group'],"['timeliness of the second and third visits of the primary immunization series', 'rates of visit completion']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1136359', 'cui_str': 'Cell Phone'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1328526', 'cui_str': 'Primary immunization'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1328526', 'cui_str': 'Primary immunization'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}]",871.0,0.107779,"CONCLUSION


Caregivers who were sent text message reminders in urban and rural Guatemala were less delayed for their child's immunization visits and reported high user satisfaction.","[{'ForeName': 'Gretchen J', 'Initials': 'GJ', 'LastName': 'Domek', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, B065, 13123 E. 16th Ave., Aurora, CO 80045, USA; Center for Global Health, Colorado School of Public Health, A090, 13199 E. Montview Blvd., Suite 310, Aurora, CO 80045, USA. Electronic address: gretchen.domek@childrenscolorado.org.'}, {'ForeName': 'Ingrid L', 'Initials': 'IL', 'LastName': 'Contreras-Roldan', 'Affiliation': 'Center for Health Studies, Universidad del Valle de Guatemala, 18 Av. 11-95, Zona 15, Vista Hermosa III, Guatemala City, Guatemala.'}, {'ForeName': 'Sheana', 'Initials': 'S', 'LastName': 'Bull', 'Affiliation': 'Center for Global Health, Colorado School of Public Health, A090, 13199 E. Montview Blvd., Suite 310, Aurora, CO 80045, USA; Department of Community and Behavioral Health, Colorado School of Public Health, B119, 13001 E. 17th Place, Aurora, CO 80045, USA.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, B065, 13123 E. 16th Ave., Aurora, CO 80045, USA; Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado Anschutz Medical Campus, F443, 13199 E. Montview Blvd., Suite 300, Aurora, CO 80045, USA.'}, {'ForeName': 'Guillermo Antonio', 'Initials': 'GA', 'LastName': 'Bolaños Ventura', 'Affiliation': 'Center for Human Development at the Southwest Trifinio, Finca Mojarras, Aldea Los Encuentros, Caballo Blanco, Retalhuleu, Guatemala.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bronsert', 'Affiliation': 'Center for Global Health, Colorado School of Public Health, A090, 13199 E. Montview Blvd., Suite 310, Aurora, CO 80045, USA; Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado Anschutz Medical Campus, F443, 13199 E. Montview Blvd., Suite 300, Aurora, CO 80045, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, B065, 13123 E. 16th Ave., Aurora, CO 80045, USA; Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado Anschutz Medical Campus, F443, 13199 E. Montview Blvd., Suite 300, Aurora, CO 80045, USA.'}, {'ForeName': 'Edwin J', 'Initials': 'EJ', 'LastName': 'Asturias', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, B065, 13123 E. 16th Ave., Aurora, CO 80045, USA; Center for Global Health, Colorado School of Public Health, A090, 13199 E. Montview Blvd., Suite 310, Aurora, CO 80045, USA; Department of Epidemiology, Colorado School of Public Health, B119, 13001 E. 17th Place, Aurora, CO 80045, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.08.046']
3294,31554943,Effect of multiple subconjunctival conbercept injections as an adjuvant to the surgical treatment of pterygium: a prospective randomised comparative 6-month follow-up study.,"OBJECTIVE


To evaluate the safety and efficacy of multiple subconjunctival injections of conbercept for pterygium patients after surgery.
METHODS


As a prospective randomised interventional trial, 96 eyes from 96 patients with a tendency to recur were collected and divided randomly into conbercept and 5-fluorouracil groups on the 5th day after pterygium. All patients received three subconjunctival injections of conbercept (0.2 ml) or 5-fluorouracil (0.2 ml) on the 5th day (baseline), and 2 and 4 weeks post-operatively. The pterygium morphology, colour intensity, recurrence, and complications were recorded and analysed pre-1st injection and 1 day, 1 week, 1 month, 3 months, and 6 months post-3rd injection. Moreover, no patient was drop-out.
RESULTS


There were striking differences between the two groups on post-3rd injections 1 day, 1 week, 1 month, 3 months, and 6 months (p = 0.001, 0.002, 0.000, 0.000, and 0.002, respectively) with respect to colour intensity: the eyes in conbercept group were lighter than the 5-Fu group. On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group. Moreover, corneal abrasions were not noted in the conbercept group, which was significantly less than the 5-Fu group (17/48; p = 0.000). There was no conspicuous discrepancy between the two groups with respect to subconjunctival haemorrhage (p = 0.789) and persistent epithelial defects (p = 0.078).
CONCLUSION


Multiple subconjunctival conbercept injections as an adjunct therapy for pterygium surgery was shown to be safe, effective, and well-tolerated.",2020,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","['pterygium', '96 eyes from 96 patients with a tendency to recur', 'pterygium patients after surgery']","['5-Fu', 'multiple subconjunctival conbercept injections', 'conbercept and 5-fluorouracil', 'multiple subconjunctival injections of conbercept', 'subconjunctival injections of conbercept (0.2\u2009ml) or 5-fluorouracil']","['corneal abrasions', 'pterygium morphology, colour intensity, recurrence, and complications', 'subconjunctival haemorrhage', 'persistent epithelial defects', 'safe, effective, and well-tolerated', 'recurrence', 'pterygium morphology', 'safety and efficacy']","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival (qualifier value)'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0197180', 'cui_str': 'Subconjunctival injection (procedure)'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0010032', 'cui_str': 'Corneal abrasion (disorder)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage (disorder)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0163744,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Quanxi', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'School of Information Management and statistics, Hubei University of Economics, No. 8 Yangqiaohu Road, 430205, Wuhan, Hubei, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Donglai', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Honghu, No 142. Xinjian Road, 433202, Honghu, Hubei, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ke', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China. keminyk@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0596-7']
3295,31115592,Effects of zoledronic acid on bone mineral density around prostheses and bone metabolism markers after primary total hip arthroplasty in females with postmenopausal osteoporosis.,"INTRODUCTION


To investigate the effect of zoledronic acid on periprosthetic bone mineral density (BMD) and bone metabolism markers after primary total hip arthroplasty in females with postmenopausal osteoporosis.
METHODS


From November 2015 to April 2016, 40 female patients who met the inclusion criteria were randomized into two groups: a control group (calcium + calcitriol) and a zoledronic acid group (calcium + calcitriol + zoledronic acid). At 1 week and 3, 6, and 12 months after operation, BMD was obtained through dual-energy X-ray absorptiometry (DEXA). At pre-operation and at 3, 6, and 12 months after the operation, levels of bone metabolism markers were obtained by serum examination.
RESULTS


Loss of BMD was significantly more pronounced in the control group than in the ZOL group in zones 1, 4, 6, and 7 at 6 months and in zones 1, 2, 4, 6, and 7 at 12 months after the operation. The levels of bone-resorption marker (β-CTX) were significantly lower in the ZOL group than in the control group at 3, 6, and 12 months after operation. The levels of bone-formation marker (TP1NP) performed statistically differences only at 12 months after the operation in these two groups.
CONCLUSIONS


Receiving an intravenous infusion of 5 mg zoledronic acid after THA can effectively reduce periprosthetic BMD loss and improve bone remodeling in females with postmenopausal osteoporosis. Zoledronic acid significantly inhibited bone mass loss in zones 1, 2, 4, 6, and 7 after THA and inhibited bone-resorption marker (β-CTX) to improve bone remodeling. Zoledronic acid treatment is potentially important for patients with osteoporosis after THA.",2019,"The levels of bone-resorption marker (β-CTX) were significantly lower in the ZOL group than in the control group at 3, 6, and 12 months after operation.","['primary total hip arthroplasty in females with postmenopausal osteoporosis', 'From November 2015 to April 2016, 40 female patients who met the inclusion criteria', 'patients with osteoporosis after THA', 'females with postmenopausal osteoporosis']","['control group (calcium + calcitriol', 'ZOL', 'zoledronic acid after THA', 'zoledronic acid', 'Zoledronic acid', 'zoledronic acid group (calcium + calcitriol + zoledronic acid']","['bone mass loss', 'levels of bone metabolism markers', 'BMD', 'periprosthetic bone mineral density (BMD) and bone metabolism markers', 'bone remodeling', 'levels of bone-resorption marker (β-CTX', 'bone mineral density around prostheses and bone metabolism markers', 'levels of bone-formation marker (TP1NP', 'periprosthetic BMD loss']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0642413', 'cui_str': 'THAS'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0006674', 'cui_str': '1,25-dihydroxycholecalciferol'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}]",40.0,0.0146521,"The levels of bone-resorption marker (β-CTX) were significantly lower in the ZOL group than in the control group at 3, 6, and 12 months after operation.","[{'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of University of Science and Technology of China, 17, Lu Jiang Road, Hefei, 230001, People's Republic of China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Soochow University, 188, Shi Zi Road, Suzhou, 215006, People's Republic of China.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Soochow University, 188, Shi Zi Road, Suzhou, 215006, People's Republic of China.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Soochow University, 188, Shi Zi Road, Suzhou, 215006, People's Republic of China. Soochowspine@sina.com.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Soochow University, 188, Shi Zi Road, Suzhou, 215006, People's Republic of China. xuyaozeng@163.com.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Soochow University, 188, Shi Zi Road, Suzhou, 215006, People's Republic of China. szgengdc@163.com.""}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05005-7']
3296,32130122,Feasibility of an Electronic Health Tool to Promote Physical Activity in Primary Care: Pilot Cluster Randomized Controlled Trial.,"BACKGROUND


Physical inactivity is associated with increased health risks. Primary care providers (PCPs) are well positioned to support increased physical activity (PA) levels through screening and provision of PA prescriptions. However, PCP counseling on PA is not common.
OBJECTIVE


This study aimed to assess the feasibility of implementing an electronic health (eHealth) tool to support PA counseling by PCPs and estimate intervention effectiveness on patients' PA levels.
METHODS


A pragmatic pilot study was conducted using a stepped wedge cluster randomized trial design. The study was conducted at a single primary care clinic, with 4 pre-existing PCP teams. Adult patients who had a periodic health review (PHR) scheduled during the study period were invited to participate. The eHealth tool involved an electronic survey sent to participants before their PHR via an email or a tablet; data were used to automatically produce tailored resources and a PA prescription in the electronic medical record of participants in the intervention arm. Participants assigned to the control arm received usual care from their PCP. Feasibility was assessed by the proportion of completed surveys and patient-reported acceptability and fidelity measures. The primary effectiveness outcome was patient-reported PA at 4 months post-PHR, measured as metabolic equivalent of task (MET) minutes per week. Secondary outcomes assessed determinants of PA, including self-efficacy and intention to change based on the Health Action Process Approach behavior change theory.
RESULTS


A total of 1028 patients receiving care from 34 PCPs were invited to participate and 530 (51.55%) consented (intervention [n=296] and control [n=234]). Of the participants who completed a process evaluation, almost half (88/178, 49.4%) stated they received a PA prescription, with only 42 receiving the full intervention including tailored resources from their PCP. A cluster-level linear regression analysis yielded a non-statistically significant positive difference in MET-minutes reported per week at follow-up between intervention and control conditions (mean difference 1027; 95% CI -155 to 2209; P=.09). No statistically significant differences were observed for secondary outcomes.
CONCLUSIONS


Our results suggest that it is feasible to build an eHealth tool that screens and provides tailored resources for PA in a primary care setting but suboptimal intervention fidelity suggests greater work must be done to address PCP barriers to resource distribution. Participant responses to the primary effectiveness outcome (MET-minutes) were highly variable, reflecting a need for more robust measures of PA in future trials to address limitations in patient-reported data.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03181295; https://clinicaltrials.gov/ct2/show/NCT03181295.",2020,"No statistically significant differences were observed for secondary outcomes.
","['Adult patients who had a periodic health review (PHR) scheduled during the study period were invited to participate', 'participants who completed a process evaluation, almost half (88/178, 49.4%) stated they received a PA prescription, with only 42 receiving the', 'Primary Care', '1028 patients receiving care from 34 PCPs were invited to participate and 530 (51.55%) consented', 'single primary care clinic, with 4 pre-existing PCP teams', ""patients' PA levels""]","['full intervention including tailored resources from their PCP', 'PCP counseling', 'Electronic Health Tool', 'usual care from their PCP']","['patient-reported PA at 4 months post-PHR, measured as metabolic equivalent of task (MET) minutes per week', 'determinants of PA, including self-efficacy and intention to change based on the Health Action Process Approach behavior change theory', 'physical activity (PA) levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2983100', 'cui_str': 'MET - metabolic equivalent of task'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C4046027', 'cui_str': 'Approach Behavior'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1028.0,0.119664,"No statistically significant differences were observed for secondary outcomes.
","[{'ForeName': 'Payal', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': ""Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Kithulegoda', 'Affiliation': ""Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Bouck', 'Affiliation': ""Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Bosiak', 'Affiliation': ""Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Birnbaum', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Reddeman', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Liane', 'Initials': 'L', 'LastName': 'Steiner', 'Affiliation': ""St Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Liora', 'Initials': 'L', 'LastName': 'Altman', 'Affiliation': 'Ontario Ministry of Health and Long-Term Care, Toronto, ON, Canada.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Mawson', 'Affiliation': 'Department of Family and Community Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Propp', 'Affiliation': 'Rehabilitation Sciences Institute, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'Fowler Kennedy Sport Medicine Clinic, Western University, London, ON, Canada.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Ivers', 'Affiliation': ""Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.""}]",Journal of medical Internet research,['10.2196/15424']
3297,31846113,"Patellofemoral pain: One year results of a randomized trial comparing hip exercise, knee exercise, or free activity.","OBJECTIVE


Extended follow-up of a randomized trial comparing hip-focused exercise, knee-focused exercise, and free physical activity in patellofemoral pain (PFP).
METHODS


A single-blind randomized controlled trial included 112 patients aged 16-40 years (mean 27.6 years) with a clinical diagnosis of PFP ≥3 months (mean 39 months) and pain ≥3/10 on a Visual Analog Scale. Patients were randomized to a 6-week exercise-based intervention consisting of either isolated hip-focused exercises (n = 39), traditional knee-focused exercise (n = 37), or free physical activity (n = 36). All patients received the same patient education. The primary outcome measure was the Anterior Knee Pain Scale (AKPS, 0-100). Secondary outcomes were usual and worst pain, Tampa Scale of Kinesiophobia, Knee Self-Efficacy Score, Euro-Qol (EQ-5D-5L), step-down test, and isometric strength. Blinded observers assessed outcomes at baseline, 3, and 12 months. The study was designed to detect a difference in AKPS >10 at 12 months.
RESULTS


After 1 year, there were no significant between-group differences in any primary or secondary outcomes. Between-group differences for AKPS were as follows: knee versus free physical activity -4.3 (95% CI -12.3 to 3.7); hip versus free physical activity -1.1 (95% CI -8.9 to 6.7); and hip versus Knee 3.2 (95% CI -4.6 to 11.0). The cohort as a whole improved significantly at 3 and 12 months compared to baseline for all measures except for knee extension strength.
CONCLUSION


After 1 year, there was no difference in effectiveness of knee exercise, hip exercise, or free physical activity, when combined with patient education in PFP.",2020,"The cohort as a whole improved significantly at 3 months and 12 months compared to baseline for all measures except for knee extension strength.
","['112 patients aged 16-40 years (mean 27.6 years) with a clinical diagnosis of PFP ≥3 months (mean 39 months) and pain ≥3/10 on a Visual Analog Scale', 'patellofemoral pain (PFP']","['hip-focused exercise, knee-focused exercise and free physical activity', 'hip exercise, knee exercise or free activity', '6-week exercise-based intervention consisting of either isolated hip-focused exercises (n=39), traditional knee-focused exercise (n=37) or free physical activity']","['knee extension strength', 'effectiveness of knee exercise, hip exercise or free physical activity', 'Patellofemoral pain', 'Anterior Knee Pain Scale (AKPS, 0-100', 'usual and worst pain, Tampa Scale of Kinesiophobia, Knee Self-Efficacy Score, Euro-Qol (EQ-5D-5L), step-down test, and isometric strength']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0454362', 'cui_str': 'Hip exercises (regime/therapy)'}, {'cui': 'C0454364', 'cui_str': 'Knee exercises (regime/therapy)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0454364', 'cui_str': 'Knee exercises (regime/therapy)'}, {'cui': 'C0454362', 'cui_str': 'Hip exercises (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",112.0,0.136707,"The cohort as a whole improved significantly at 3 months and 12 months compared to baseline for all measures except for knee extension strength.
","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hott', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Sørlandet Hospital Kristiansand, Kristiansand, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Are Hugo', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Niels Gunnar', 'Initials': 'NG', 'LastName': 'Juel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Liavaag', 'Affiliation': 'Department of Orthopedic Surgery, Sørlandet Hospital Kristiansand, Kristiansand, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13613']
3298,31876029,The placebo effect on aerobic fitness test results is preserved following a multidisciplinary intervention program for treating childhood obesity.,"BACKGROUND


The aim of the study was to examine the placebo effect on fitness test results in trained and untrained overweight and obese children.
METHODS


Twenty pre-pubertal overweight children performed two pairs of progressive treadmill exercise tests before and 12 weeks into a multidisciplinary program for the treatment of childhood obesity. In each test pair, at random order, participants received different types of information regarding a water drink consumed prior to testing-standard information (water) vs deliberate positive information (presumed energy drink, placebo).
RESULTS


The intervention led to a significant change (P < .05) in BMI%ile (95.6 ± 4.4 vs 93.6 ± 6.9), % fat (35.4 ± 6.0 vs 31.6 ± 5.8), baseline heart rate (104.2 ± 11.6 vs 94.0 ± 7.0 bpm), total leisure activity score-Godin (9.3 ± 8.8 vs 41.5 ± 15.2), total screen time (6.9 ± 5.8 vs 3.1 ± 1.4 h/d), and a significant improvement in fitness. Following the placebo drink, both groups achieved a significantly higher peak heart rate (untrained: 176.1 ± 13.7 vs 167.5 ± 16.8; trained: 170.7 ± 11.6 vs 166.2 ± 11.4 bpm) and longer running time (untrained: 559.9 ± 151.0 vs 434.4 ± 140.3 seconds; trained: 728.3 ± 177.3 vs 667.1 ± 176.1 seconds). Despite longer exercise duration and higher peak exercise heart rate, average, and peak RPE were lower after the placebo drink (untrained: 12.1 ± 2.3 vs 13.6 ± 2.1; trained:10.0 ± 1.8 vs 11.6 ± 2.1), recovery time was shorter (untrained: 119.2 ± 25.3 vs 133.2 ± 23.7 seconds; trained: 92.6 ± 18.9 vs 102.7 ± 18.3 seconds). The placebo-induced change in running time and peak RPE were significantly greater prior to training.
CONCLUSION


The significant information placebo effect is preserved in trained overweight children. Information, as well as other motivating aids and fatigue distractors may be useful in enhancing physical performance in obese children.",2020,"The intervention led to a significant change (p<0.05) in BMI%ile (95.6±4.4 versus 93.6±6.9), % fat (35.4±6.0 versus 31.6±5.8), baseline heart rate (104.2±11.6 vs 94.0±7.0 bpm), total leisure activity score-Godin (9.3±8.8 versus 41.5±15.2), total screen time (6.9±5.8 versus 3.1±1.4h/day), running time (434.4±140.3 versus 667.1±176.1sec), peak rate of perceived exertion (RPE) (19.1±1.5 versus 16.9±2.2) and recovery time (133.2±23.7 versus 102.7±18.3 sec).","['Twenty pre-pubertal overweight children', 'trained and untrained overweight and obese children', 'trained overweight children', 'untrained']","['placebo', 'water drink consumed prior to testing - standard information (water) versus deliberate positive information (presumed energy drink, placebo', 'multidisciplinary program', 'progressive treadmill exercise tests']","['longer running time (untrained', 'total screen time', 'running time', 'running time and peak RPE', 'baseline heart rate', 'total leisure activity score-Godin', 'peak heart rate', 'recovery time', 'peak rate of perceived exertion (RPE', 'exercise duration and higher peak exercise heart rate, average, and peak RPE']","[{'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3179078', 'cui_str': 'Energy Drinks'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}]","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",20.0,0.398084,"The intervention led to a significant change (p<0.05) in BMI%ile (95.6±4.4 versus 93.6±6.9), % fat (35.4±6.0 versus 31.6±5.8), baseline heart rate (104.2±11.6 vs 94.0±7.0 bpm), total leisure activity score-Godin (9.3±8.8 versus 41.5±15.2), total screen time (6.9±5.8 versus 3.1±1.4h/day), running time (434.4±140.3 versus 667.1±176.1sec), peak rate of perceived exertion (RPE) (19.1±1.5 versus 16.9±2.2) and recovery time (133.2±23.7 versus 102.7±18.3 sec).","[{'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Fanti-Oren', 'Affiliation': 'Cheryl Spencer Department of Nursing, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Birenbaum-Carmeli', 'Affiliation': 'Cheryl Spencer Department of Nursing, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Eliakim', 'Affiliation': 'Pediatric Department, Child Health Sport Center, Meir Medical Center, Tel-Aviv University, Sackler School of Medicine, Tel-Aviv, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Pantanowitz', 'Affiliation': 'Pediatric Department, Child Health Sport Center, Meir Medical Center, Tel-Aviv University, Sackler School of Medicine, Tel-Aviv, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Nemet', 'Affiliation': 'Pediatric Department, Child Health Sport Center, Meir Medical Center, Tel-Aviv University, Sackler School of Medicine, Tel-Aviv, Israel.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13621']
3299,31542129,Randomized Trial of Low-Nicotine Cigarettes and Transdermal Nicotine.,"INTRODUCTION


A mandated reduction in the nicotine content of cigarettes may decrease smoking, but also increase demand for other nicotine products. The present study tested the impact of smoking cigarettes with very low nicotine content and concurrent use of a transdermal nicotine patch.
STUDY DESIGN


A balanced 2 × 2 factorial randomized clinical trial investigating the impact of cigarette nicotine content (double-blind, very low nicotine content versus normal nicotine content) and use of a transdermal nicotine patch (open label, patch versus no patch).
SETTING/PARTICIPANTS


Adult daily smokers (n=240) in the Pittsburgh, PA area.
INTERVENTION


Participants were provided with research cigarettes and transdermal nicotine patches (if assigned to patch condition) for 7 weeks. Cigarettes were Spectrum brand (National Institute on Drug Abuse) and either 15.8 mg nicotine/g tobacco (normal nicotine content) or 0.4 mg nicotine/g tobacco (very low nicotine content). In the 7th week, participants were monetarily incentivized to abstain from smoking.
MAIN OUTCOME MEASURES


Participants reported daily cigarette use throughout the trial and the primary outcome was average number of cigarettes smoked per day (study + nonstudy) during Week 6. Participants were recruited from 2015 to 2017 and data were analyzed between 2017 and 2018.
RESULTS


Assignment to very low nicotine content cigarettes and assignment to wear a nicotine patch both reduced the number of cigarettes smoked per day during Week 6 (p=0.001 and 0.04, respectively). However, assignment to the patch along with very low nicotine content cigarettes did not significantly reduce cigarette smoking compared with assignment to very low nicotine content cigarettes alone.
CONCLUSIONS


A mandated reduction in the nicotine content of cigarettes is likely to reduce the number of cigarettes smoked per day, but the added benefit of concurrent transdermal nicotine is unclear. Future studies should investigate whether alternative sources of noncombusted tobacco, such as e-cigarettes, enhance the effects of very low nicotine content cigarettes on smoking.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT02301325.",2019,"both reduced the number of cigarettes smoked per day during Week 6 (p=0.001 and 0.04, respectively).","['Adult daily smokers (n=240) in the Pittsburgh, PA area', 'Participants were recruited from 2015 to 2017 and data were analyzed between 2017 and 2018']","['research cigarettes and transdermal nicotine patches', 'nicotine/g tobacco (normal nicotine content) or 0.4 mg nicotine', 'transdermal nicotine patch (open label, patch versus no patch', 'cigarette nicotine content (double-blind, very low nicotine content versus normal nicotine content', 'nicotine patch', 'Low-Nicotine Cigarettes and Transdermal Nicotine', 'transdermal nicotine patch']","['daily cigarette use', 'number of cigarettes smoked', 'cigarette smoking', 'average number of cigarettes smoked']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0035168'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke (substance)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}]",,0.036303,"both reduced the number of cigarettes smoked per day during Week 6 (p=0.001 and 0.04, respectively).","[{'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina; Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina. Electronic address: smithtra@musc.edu.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota; Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katelyn M', 'Initials': 'KM', 'LastName': 'Tessier', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Esa M', 'Initials': 'EM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Conklin', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown School of Public Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Lane', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota; Department of Biochemistry Molecular Biology and BioPhysics, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown School of Public Health, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota; Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.05.010']
3300,31415883,Selective effects of acute low-grade inflammation on human visual attention.,"Illness is often accompanied by perceived cognitive sluggishness, a symptom that may stem from immune system activation. The current study used electroencephalography (EEG) to assess how inflammation affected three different distinct attentional processes: alerting, orienting and executive control. In a double-blinded placebo-controlled within-subjects design (20 healthy males, mean age = 24.5, SD = 3.4), Salmonella typhoid vaccination (0.025 mg; Typhim Vi, Sanofi Pasteur) was used to induce transient mild inflammation, while a saline injection served as a placebo-control. Participants completed the Attention Network Test with concurrent EEG recorded 6 h post-injection. Analyses focused on behavioral task performance and on modulation of oscillatory EEG activity in the alpha band (9-12 Hz) for alerting as well as orienting attention and frontal theta band (4-8 Hz) for executive control. Vaccination induced mild systemic inflammation, as assessed by interleukin-6 (IL-6) levels. While no behavioral task performance differences between the inflammation and placebo condition were evident, inflammation caused significant alterations to task-related brain activity. Specifically, inflammation produced greater cue-induced suppression of alpha power in the alerting aspect of attention and individual variation in the inflammatory response was significantly correlated with the degree of alpha power suppression. Notably, inflammation did not affect orienting (i.e., alpha lateralization) or executive control (i.e., frontal theta activity). These results reveal a unique neurophysiological sensitivity to acute mild inflammation of the neural network that underpins attentional alerting functions. Observed in the absence of performance decrements, these novel findings suggest that acute inflammation requires individuals to exert greater cognitive effort when preparing for a task in order to maintain adequate behavioral performance.",2019,Analyses focused on behavioral task performance and on modulation of oscillatory EEG activity in the alpha band (9-12 Hz) for alerting as well as orienting attention and frontal theta band (4-8 Hz) for executive control.,"['20 healthy males, mean age\u202f=\u202f24.5, SD\u202f=\u202f3.4), Salmonella typhoid vaccination (0.025\u202fmg; Typhim Vi, Sanofi Pasteur']","['placebo-control', 'placebo', 'electroencephalography (EEG']","['interleukin-6 (IL-6) levels', 'mild systemic inflammation', 'inflammation did not affect orienting (i.e., alpha lateralization) or executive control (i.e., frontal theta activity', 'behavioral task performance', 'oscillatory EEG activity']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C0036111', 'cui_str': 'Salmonella'}, {'cui': 'C0199801', 'cui_str': 'Typhoid vaccination (procedure)'}, {'cui': 'C4517400', 'cui_str': 'Zero point zero two five'}, {'cui': 'C0378248', 'cui_str': 'Typhim VI'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0013819', 'cui_str': 'EEG'}]",20.0,0.210364,Analyses focused on behavioral task performance and on modulation of oscillatory EEG activity in the alpha band (9-12 Hz) for alerting as well as orienting attention and frontal theta band (4-8 Hz) for executive control.,"[{'ForeName': 'Leonie Jt', 'Initials': 'LJ', 'LastName': 'Balter', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, B15 2TT, UK; Psychology Department, Clinical Psychology, University of Amsterdam, Amsterdam, 1018 WT, NL, UK. Electronic address: l.j.t.balter@uva.nl.'}, {'ForeName': 'Jos A', 'Initials': 'JA', 'LastName': 'Bosch', 'Affiliation': 'Psychology Department, Clinical Psychology, University of Amsterdam, Amsterdam, 1018 WT, NL, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Aldred', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Institute of Immunity and Immunotherapy, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Jet Jcs', 'Initials': 'JJ', 'LastName': 'Veldhuijzen van Zanten', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Higgs', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Raymond', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mazaheri', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, B15 2TT, UK; Centre for Human Brain Health, University of Birmingham, Birmingham, B15 2TT, UK.'}]",NeuroImage,['10.1016/j.neuroimage.2019.116098']
3301,31127837,A Randomized Clinical Trial of Group Acupuncture for Painful Diabetic Neuropathy Among Diverse Safety Net Patients.,"OBJECTIVE


Existing pharmacologic approaches for painful diabetic neuropathy (PDN) are limited in efficacy and have side effects. We examined the feasibility, acceptability, and effects of group acupuncture for PDN.
DESIGN AND SETTING


We randomized patients with PDN from a public safety net hospital to 1) usual care, 2) usual care plus 12 weeks of group acupuncture once weekly, or 3) usual care plus 12 weeks of group acupuncture twice weekly.
METHODS


The primary outcome was change in weekly pain intensity (daily 0-10 numerical rating scale [NRS] averaged over seven days) from baseline to week 12. We also assessed health-related quality of life and related symptoms at baseline and weeks 6, 12, and 18.
RESULTS


We enrolled 40 patients with PDN (baseline pain = 5.3). Among participants randomized to acupuncture, 92% attended at least one treatment (mean treatments = 10.1). We observed no significant differences between once- vs twice-weekly acupuncture and combined those groups for the main analyses. Compared with usual care, participants randomized to acupuncture experienced greater decreases in pain during the 12-week intervention period (between-group differences from baseline = -2.06, 95% confidence interval [CI] = -3.01 to -1.10), but benefits were not maintained after acupuncture ended (baseline to week 18 = -0.61, 95% CI = -1.46 to 0.24). Quality of life improved for acupuncture participants (baseline to week 12 difference = 11.79, 95% CI = 1.92 to 21.66), but group differences were not significant compared with usual care (25.58, 95% CI = -3.90 to 55.06).
CONCLUSIONS


Group acupuncture is feasible and acceptable among linguistically and racially diverse safety net patients. Findings suggest clinically relevant reduction in pain from PDN and quality of life improvements associated with acupuncture, with no differences based on frequency.",2019,"Quality of life improved for acupuncture participants (baseline to week 12 difference = 11.79, 95% CI = 1.92 to 21.66), but group differences were not significant compared with usual care (25.58, 95% CI = -3.90 to 55.06).
","['40 patients with PDN (baseline pain\u2009=\u20095.3', 'Painful Diabetic Neuropathy Among Diverse Safety Net Patients', 'We randomized patients with PDN from a public safety net hospital to 1) usual care, 2', 'painful diabetic neuropathy (PDN']","['Group Acupuncture', 'acupuncture', 'usual care plus 12\u2009weeks of group acupuncture once weekly, or 3) usual care plus 12\u2009weeks of group acupuncture twice weekly']","['health-related quality of life and related symptoms', 'change in weekly pain intensity (daily 0-10 numerical rating scale [NRS', 'pain', 'Quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0751074', 'cui_str': 'Diabetic Neuralgia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.286772,"Quality of life improved for acupuncture participants (baseline to week 12 difference = 11.79, 95% CI = 1.92 to 21.66), but group differences were not significant compared with usual care (25.58, 95% CI = -3.90 to 55.06).
","[{'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Chao', 'Affiliation': 'Osher Center for Integrative Medicine.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Unity', 'Initials': 'U', 'LastName': 'Nguyen', 'Affiliation': 'Osher Center for Integrative Medicine.'}, {'ForeName': 'Trilce', 'Initials': 'T', 'LastName': 'Santana', 'Affiliation': 'Osher Center for Integrative Medicine.'}, {'ForeName': 'Rhianon', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Osher Center for Integrative Medicine.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Gregorich', 'Affiliation': 'Division of General Internal Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': 'Osher Center for Integrative Medicine.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz117']
3302,32105658,Correlation Between Oral Health and Systemic Inflammation (COHESION): A Randomized Pilot Follow-Up Trial of a Plaque-Identifying Toothpaste.,"BACKGROUND


Inflammation is intimately involved in the pathogenesis of atherosclerosis and is accurately measured by high-sensitivity C-reactive protein (hs-CRP), a sensitive marker for future risk of cardiovascular disease. The Correlation between Oral Health and Systemic Inflammation (COHESION) trial was designed to test the hypothesis that PlaqueHD, a plaque-identifying toothpaste, reduces hs-CRP.
METHODS


The trial was designed initially to include 132 subjects with hs-CRP between 2.0 and 10.0 mg/L but instead randomized 112 between 0.5 and 10.0, of which 103 had baseline and follow-up data and comprised the intention-to-treat sample. Of these, a prespecified subgroup analysis included 40 with baseline hs-CRP >2.0 and all hs-CRP <10. Because the distribution of hs-CRP was skewed toward higher values, to achieve normality assumptions, the significance of changes in hs-CRP between groups over time was tested on log-transformed data using a mixed effects analysis of variance.
RESULTS


The intention-to-treat analysis showed no significant differences between the PlaqueHD and placebo group (P = .615). The prespecified subgroup analysis showed a significant difference between the PlaqueHD and placebo group (P = .047). Results of the analysis showed a reduction in hs-CRP at follow-up of 0.58 in the PlaqueHD and an increase of 0.55 in the placebo group.
CONCLUSIONS


These findings are compatible with those of a prior pilot trial that also suggested benefits only in subjects with baseline elevations. Future trials targeting reductions of hs-CRP levels should randomize subjects with baseline hs-CRP between 2.0 and 10.0 mg/L.",2020,The pre-specified subgroup analysis showed a significant difference between the PlaqueHD and placebo group (p=0.047).,"['COHESION was designed initially to enroll 132 subjects with hs-CRP between 2.0 and 10.0 milligrams per liter but randomized 112 between 0.5 and 10.0, of which 103 had baseline and follow up data and comprise the intention to treat sample']","['placebo', 'Plaque Identifying Toothpaste']",[],"[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439210', 'cui_str': 'milligram'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}]",[],112.0,0.42989,The pre-specified subgroup analysis showed a significant difference between the PlaqueHD and placebo group (p=0.047).,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Acharya', 'Affiliation': 'Marshfield Clinic Research Institute, Marshfield, WI; University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Glurich', 'Affiliation': 'Marshfield Clinic Research Institute, Marshfield, WI.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hetzel', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Tattersall', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hennekens', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL. Electronic address: PROFCHHMD@prodigy.net.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.01.023']
3303,32101872,"The Combined Effect of Polygenic Risk from FTO and ADRB2 Gene Variants, Odds of Obesity, and Post-Hipcref Diet Differences.","BACKGROUND


Computing polygenic risk scores (PRS) to predict the degree of risk for obesity may contribute to weight management programs strategically.
OBJECTIVES


To investigate the combined effect of FTO rs9930501, rs9930506, and rs9932754 and ADRB2 rs1042713 and rs1042714 using PRS on (1) the odds of obesity and (2) post-intervention differences in dietary, anthropometric, and cardiometabolic parameters in response to high-protein calorie-restricted, high-vitamin E, high-fiber (Hipcref) diet intervention in Malaysian adults.
METHODS


Both a cross-sectional study (n = 178) and a randomized controlled trial (RCT) (n = 128) were conducted to test the aforementioned objectives. PRS was computed as the weighted sum of the risk alleles possessed by each individual participant. Participants were stratified into first (PRS 0-0.64), second (PRS 0.65-3.59), and third (PRS 3.60-8.18) tertiles.
RESULTS


The third tertile of PRS was associated with significantly higher odds of obesity: 2.29 (95% CI = 1.11-4.72, adjusted p = 0.025) compared to the first tertile. Indians (3.9 ± 0.3) had significantly higher PRS compared to Chinese (2.1 ± 0.4) (p = 0.010). In the RCT, a greater reduction in high-sensitivity C-reactive protein (hsCRP) levels was found in second and third tertiles after Hipcref diet intervention compared to the control diet (p interaction = 0.048).
CONCLUSION


Higher PRS was significantly associated with increased odds of obesity. Individuals with higher PRS had a significantly greater reduction in hsCRP levels after Hipcref diet compared to the control diet.",2020,Individuals with higher PRS had a significantly greater reduction in hsCRP levels after Hipcref diet compared to the control diet.,"['Malaysian adults', 'Both a cross-sectional study (n = 178) and a randomized controlled trial (RCT) (n = 128']","['high-protein calorie-restricted, high-vitamin E, high-fiber (Hipcref) diet intervention']","['high-sensitivity C-reactive protein (hsCRP) levels', 'hsCRP levels', 'obesity', 'odds of obesity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0301568', 'cui_str': 'High residue diet (finding)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",128.0,0.0178011,Individuals with higher PRS had a significantly greater reduction in hsCRP levels after Hipcref diet compared to the control diet.,"[{'ForeName': 'Pui Yee', 'Initials': 'PY', 'LastName': 'Tan', 'Affiliation': 'School of Biosciences, Faculty of Science and Engineering, University of Nottingham Malaysia, Semenyih, Malaysia.'}, {'ForeName': 'Soma Roy', 'Initials': 'SR', 'LastName': 'Mitra', 'Affiliation': 'School of Biosciences, Faculty of Science and Engineering, University of Nottingham Malaysia, Semenyih, Malaysia, soma.mitra@nottingham.edu.my.'}]",Lifestyle genomics,['10.1159/000505662']
3304,32173730,"Effects of Intravenous Tranexamic Acid During Rhytidectomy: A Randomized, Controlled, Double-Blind Pilot Study.","BACKGROUND


Tranexamic acid (TXA) is an anti-fibrinolytic agent shown to decrease intraoperative bleeding, reduce transfusions, and improve outcomes across multiple specialties. Within plastic surgery, initial reports are encouraging but formal studies are lacking. A study was designed to assess whether TXA demonstrates noticeable benefit for rhytidectomy to warrant further investigation.
OBJECTIVE


To determine whether intravenous (IV) TXA has effect on intraoperative bleeding, or postoperative sequelae in patients undergoing a deep-plane facelift.
METHODS


This is a prospective, randomized, double-blind, case series in a private practice surgery center. Participants included 44 patients undergoing rhytidectomy with the senior authors (R.A.G. or M.J.G). Treatment group received 1 gram of IV TXA prior to skin incision, and 4 hours later (vs saline). Bleeding was rated mild, moderate, or severe. Postoperative ecchymosis and edema were subjectively evaluated by patient and surgeon and scores were aggregated for analysis.
RESULTS


The TXA group showed decreased intraoperative bleeding but did not reach statistical significance. Postoperative ecchymosis/edema ratings were lower for patients who received TXA, including a statistically significant decrease in surgeon-rated bruising. TXA resulted in a statistically significant decrease in postoperative collections in this study and no major complications occurred.
CONCLUSIONS


TXA is a safe, low-cost, addition to any existing surgical protocol and may lead to less surgical sequelae and improved satisfaction. Although, we did not observe a dramatically different intraoperative experience, postoperative bruising and collections were significantly reduced. Tranexamic acid may have great value in the management of patients undergoing rhytidectomy and warrants further study.",2020,"Postoperative ecchymosis/edema ratings were lower for patients who received TXA, including a statistically significant decrease in surgeon-rated bruising.","['private practice surgery center', 'patients undergoing a deep-plane facelift', 'patients undergoing rhytidectomy and warrants further study', 'Participants included 44 patients undergoing rhytidectomy with the senior authors (R.A.G. or M.J.G']","['intravenous (IV) TXA', 'Tranexamic acid (TXA', 'Intravenous Tranexamic Acid', 'TXA', 'Tranexamic acid', '1 gram of IV TXA']","['postoperative collections', 'Bleeding', 'intraoperative experience, postoperative bruising and collections', 'Postoperative ecchymosis/edema ratings', 'intraoperative bleeding, or postoperative sequelae', 'intraoperative bleeding', 'surgeon-rated bruising', 'Postoperative ecchymosis and edema']","[{'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0035519', 'cui_str': 'Facelift'}, {'cui': 'C0086923', 'cui_str': 'Rhytidectomy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C0243088', 'cui_str': 'sequelae'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0009938', 'cui_str': 'Bruise'}]",44.0,0.311756,"Postoperative ecchymosis/edema ratings were lower for patients who received TXA, including a statistically significant decrease in surgeon-rated bruising.","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Cohen', 'Affiliation': 'Drs Cohen, Glasgold, and Glasgold are facial plastic surgeons in private practice in Princeton, NJ.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Glasgold', 'Affiliation': 'Drs Cohen, Glasgold, and Glasgold are facial plastic surgeons in private practice in Princeton, NJ.'}, {'ForeName': 'Les M', 'Initials': 'LM', 'LastName': 'Alloju', 'Affiliation': 'Dr Alloju is a facial plastic surgery fellow at a private practice in Princeton, NJ.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Glasgold', 'Affiliation': 'Drs Cohen, Glasgold, and Glasgold are facial plastic surgeons in private practice in Princeton, NJ.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa072']
3305,32057631,Prospective Double-Blinded Randomized Field-Based Clinical Trial of Metoclopramide and Ibuprofen for the Treatment of High Altitude Headache and Acute Mountain Sickness.,"INTRODUCTION


High altitude headache (HAH) and acute mountain sickness (AMS) are common pathologies at high altitudes. There are similarities between AMS and migraine headaches, with nausea being a common symptom. Several studies have shown ibuprofen can be effective for AMS prophylaxis, but few have addressed treatment. Metoclopramide is commonly administered for migraine headaches but has not been evaluated for HAH or AMS. We aimed to evaluate metoclopramide and ibuprofen for treatment of HAH and AMS.
METHODS


We performed a prospective, double-blinded, randomized, field-based clinical trial of metoclopramide and ibuprofen for the treatment of HAH and AMS in 47 adult subjects in the Mount Everest region of Nepal. Subjects received either 400 mg ibuprofen or 10 mg metoclopramide in a 1-time dose. Lake Louise Score (LLS) and visual analog scale of symptoms were measured before and at 30, 60, and 120 min after treatment.
RESULTS


Subjects in both the metoclopramide and ibuprofen arms reported reduced headache severity and nausea compared to pretreatment values at 120 min. The ibuprofen group reported 22 mm reduction in headache and 6 mm reduction in nausea on a 100 mm visual analog scale at 120 min. The metoclopramide group reported 23 mm reduction in headache and 14 mm reduction in nausea. The ibuprofen group reported an average 3.5-point decrease on LLS, whereas the metoclopramide group reported an average 2.0-point decrease on LLS at 120 min.
CONCLUSIONS


Metoclopramide and ibuprofen may be effective alternative treatment options in HAH and AMS, especially for those patients who additionally report nausea.",2020,"RESULTS


Subjects in both the metoclopramide and ibuprofen arms reported reduced headache severity and nausea compared to pretreatment values at 120 min.","['High Altitude Headache and Acute Mountain Sickness', '47 adult subjects in the Mount Everest region of Nepal']","['Metoclopramide and ibuprofen', 'Metoclopramide', 'metoclopramide', 'metoclopramide and ibuprofen', 'Metoclopramide and Ibuprofen', 'ibuprofen', '400 mg ibuprofen']","['LLS', 'headache', 'headache severity and nausea', 'nausea', 'Lake Louise Score (LLS) and visual analog scale of symptoms']","[{'cui': 'C0238617', 'cui_str': 'High altitude (physical force)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0181909', 'cui_str': 'Mount (physical object)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",47.0,0.0540356,"RESULTS


Subjects in both the metoclopramide and ibuprofen arms reported reduced headache severity and nausea compared to pretreatment values at 120 min.","[{'ForeName': 'Hillary R', 'Initials': 'HR', 'LastName': 'Irons', 'Affiliation': 'University of Massachusetts, Emergency Medicine, Worcester, MA. Electronic address: Hillary.irons@umassmemorial.org.'}, {'ForeName': 'Renee N', 'Initials': 'RN', 'LastName': 'Salas', 'Affiliation': 'Massachusetts General Hospital, Emergency Medicine / Harvard Medical School, Boston, MA.'}, {'ForeName': 'Salman F', 'Initials': 'SF', 'LastName': 'Bhai', 'Affiliation': ""Brigham and Women's Hospital, Neurology, Boston, MA.""}, {'ForeName': 'W Douglas', 'Initials': 'WD', 'LastName': 'Gregorie', 'Affiliation': 'University of Tennessee, Erlanger Hospital, Emergency Medicine, Chattanooga, TN.'}, {'ForeName': 'N Stuart', 'Initials': 'NS', 'LastName': 'Harris', 'Affiliation': 'University of Massachusetts, Emergency Medicine, Worcester, MA.'}]",Wilderness & environmental medicine,['10.1016/j.wem.2019.11.005']
3306,31851290,Association of Prehospital Plasma Transfusion With Survival in Trauma Patients With Hemorrhagic Shock When Transport Times Are Longer Than 20 Minutes: A Post Hoc Analysis of the PAMPer and COMBAT Clinical Trials.,"Importance


Both military and civilian clinical practice guidelines include early plasma transfusion to achieve a plasma to red cell ratio approaching 1:1 to 1:2. However, it was not known how early plasma should be given for optimal benefit. Two recent randomized clinical trials were published, with apparently contradictory results. The Prehospital Air Medical Plasma (PAMPer) clinical trial showed a nearly 30% reduction in mortality with plasma transfusion in the prehospital environment, while the Control of Major Bleeding After Trauma (COMBAT) clinical trial showed no survival improvement.
Objective


To facilitate a post hoc combined analysis of the COMBAT and PAMPer trials to examine questions that could not be answered by either clinical trial alone. We hypothesized that prehospital transport time influenced the effects of prehospital plasma on 28-day mortality.
Design, Setting, and Participants


A total of 626 patients in the 2 clinical trials were included. Patients with trauma and hemorrhagic shock were randomly assigned to receive either standard care or 2 U of thawed plasma followed by standard care in the prehospital environment. Data analysis was performed between September 2018 and January 2019.
Interventions


Prehospital transfusion of 2 U of plasma compared with crystalloid-based resuscitation.
Main Outcomes and Measures


The main outcome was 28-day mortality.
Results


In this post hoc analysis of 626 patients (467 men [74.6%] and 159 women [25.4%]; median [interquartile range] age, 42 [27-57] years) who had trauma with hemorrhagic shock, a Cox regression analysis showed a significant overall survival benefit for plasma (hazard ratio [HR], 0.65; 95% CI, 0.47-0.90; P = .01) after adjustment for injury severity, age, and clinical trial cohort (COMBAT or PAMPer). A significant association with prehospital transport time was detected (from arrival on scene to arrival at the trauma center). Increased mortality was observed in patients in the standard care group when prehospital transport was longer than 20 minutes (HR, 2.12; 95% CI, 1.05-4.30; P = .04), while increased mortality was not observed in patients in the prehospital plasma group (HR, 0.78; 95% CI, 0.40-1.51; P = .46). No serious adverse events were associated with prehospital plasma transfusion.
Conclusions and Relevance


These data suggest that prehospital plasma is associated with a survival benefit when transport times are longer than 20 minutes and that the benefit-risk ratio is favorable for use of prehospital plasma.
Trial Registration


ClinicalTrials.gov identifiers: NCT01838863 (COMBAT) and NCT01818427 (PAMPer).",2020,"Increased mortality was observed in patients in the standard care group when prehospital transport was longer than 20 minutes (HR, 2.12; 95% CI, 1.05-4.30; P = .04), while increased mortality was not observed in patients in the prehospital plasma group (HR, 0.78; 95% CI, 0.40-1.51; P = .46).","['626 patients in the 2 clinical trials were included', 'Patients with trauma and hemorrhagic shock', 'Trauma Patients With Hemorrhagic Shock', '626 patients (467 men [74.6%] and 159 women [25.4%]; median [interquartile range] age, 42 [27-57] years) who had trauma with hemorrhagic shock']","['crystalloid-based resuscitation', 'standard care or 2 U of thawed plasma followed by standard care in the prehospital environment']","['28-day mortality', 'survival improvement', 'Increased mortality', 'mortality', 'Control of Major Bleeding', 'prehospital transport', 'overall survival benefit for plasma', 'prehospital transport time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}, {'cui': 'C4517784', 'cui_str': '467 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",467.0,0.389729,"Increased mortality was observed in patients in the standard care group when prehospital transport was longer than 20 minutes (HR, 2.12; 95% CI, 1.05-4.30; P = .04), while increased mortality was not observed in patients in the prehospital plasma group (HR, 0.78; 95% CI, 0.40-1.51; P = .46).","[{'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'US Army Institute of Surgical Research, JBSA-Fort Sam Houston, San Antonio, Texas.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'Department of Surgery, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'Department of Surgery, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'Tuan D', 'Initials': 'TD', 'LastName': 'Le', 'Affiliation': 'US Army Institute of Surgical Research, JBSA-Fort Sam Houston, San Antonio, Texas.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'Division of Emergency Medicine, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'Department of Radiology, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'Department of Health Systems, Management, and Policy, School of Public Health, University of Colorado Denver, Aurora.'}, {'ForeName': 'Arsen', 'Initials': 'A', 'LastName': 'Ghasabyan', 'Affiliation': 'Department of Surgery, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chandler', 'Affiliation': 'Department of Surgery, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McVaney', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Daley', 'Affiliation': 'Department of Surgery, University of Tennessee Health Science Center, Knoxville.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': 'Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': 'Department of Surgery, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Claridge', 'Affiliation': 'MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Herb A', 'Initials': 'HA', 'LastName': 'Phelan', 'Affiliation': 'Department of Surgery, Parkland Memorial Hospital, University of Texas Southwestern, Dallas.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Witham', 'Affiliation': 'Texas Health Harris Methodist Hospital, Ft Worth, Texas.'}, {'ForeName': 'A Tyler', 'Initials': 'AT', 'LastName': 'Putnam', 'Affiliation': 'Altoona Hospital, University of Pittsburgh Medical Center, Altoona, Pennsylvania.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}]",JAMA surgery,['10.1001/jamasurg.2019.5085']
3307,32068484,"International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR.","PURPOSE


We assessed efficacy, safety and tolerability of vibegron, a novel, potent, highly selective β 3 -adrenoceptor agonist, administered 12 weeks at 75 mg once daily to patients with overactive bladder in an international phase III trial with placebo and active control.
MATERIALS AND METHODS


Adult patients with overactive bladder with 8.0 or more micturitions per day were randomized 5:5:4 to 75 mg vibegron, placebo or extended-release 4 mg extended-release tolterodine. Up to 25% of patients could have dry overactive bladder (less than 1.0 urge incontinence episode per day). Patients completed 7-day voiding diaries at baseline and weeks 2, 4, 8 and 12.
RESULTS


Of 1,518 randomized patients 90.4% completed the trial. At 12 weeks micturitions decreased by an adjusted mean of 1.8 episodes per day for vibegron vs 1.3 for placebo (p <0.001, co-primary end point) and 1.6 for tolterodine. Among incontinent patients urge incontinence episodes decreased by an adjusted mean 2.0 episodes per day for vibegron vs 1.4 for placebo (p <0.0001, co-primary end point) and 1.8 for tolterodine. Moreover, vibegron was statistically significantly superior to placebo for key secondary measures of number of urgency episodes, volume per micturition and proportion of incontinent patients with a 75% or greater reduction in urge incontinence episodes (all p <0.01). Among vibegron treated patients 1.7% discontinued treatment because of adverse events vs 1.1% for placebo and 3.3% for tolterodine. Incidence of hypertension was 1.7% for vibegron and for placebo.
CONCLUSIONS


Once daily 75 mg vibegron provided statistically significant reductions in micturitions, urgency episodes and urge incontinence, and increased the volume per micturition. Treatment was well tolerated with a favorable safety profile.",2020,"CONCLUSIONS


Once-daily vibegron 75 mg provided statistically significant reductions in micturitions, urgency episodes, urge incontinence, and increased the volume per micturition.","['Adult patients with overactive bladder with ≥8.0 micturitions/day', 'Patients with Symptoms of Overactive Bladder', 'patients with overactive bladder in an international phase III trial with']","['vibegron 75 mg, placebo, or extended-release tolterodine 4 mg', 'Vibegron', 'placebo', 'placebo and active control', 'tolterodine', 'Placebo']","['efficacy, safety, and tolerability', 'number of urgency episodes, volume per micturition', 'Safety and Efficacy', '7-day voiding diaries', 'micturitions, urgency episodes, urge incontinence, and increased the volume per micturition', 'adverse events', 'urge-incontinence episodes', 'Incidence of hypertension', 'dry overactive bladder']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4279743', 'cui_str': 'vibegron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0150045', 'cui_str': 'Urinary Reflex Incontinence'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]",1518.0,0.512834,"CONCLUSIONS


Once-daily vibegron 75 mg provided statistically significant reductions in micturitions, urgency episodes, urge incontinence, and increased the volume per micturition.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Frankel', 'Affiliation': 'Seattle Urology Research Center, Seattle, Washington.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Varano', 'Affiliation': 'Clinical Research Consulting, Milford, Connecticut.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Shortino', 'Affiliation': 'Urovant Sciences, Irvine, California.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Jankowich', 'Affiliation': 'Urovant Sciences, Irvine, California.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Mudd', 'Affiliation': 'Urovant Sciences, Irvine, California.'}]",The Journal of urology,['10.1097/JU.0000000000000807']
3308,31601571,Rojiroti microfinance and child nutrition: a cluster randomised trial.,"OBJECTIVE


To determine whether Rojiroti microfinance, for poor Indian women, improves child nutrition.
DESIGN


Cluster randomised trial.
SETTING


Tolas (village communities) in Bihar State.
PARTICIPANTS


Women and children under 5 years.
INTERVENTIONS


With Rojiroti microfinance, women form self-help groups and save their money to provide loans to group members. After 6 months, they receive larger external loans. Tolas were randomised to receive Rojiroti immediately or after 18 months.
OUTCOME MEASURES


The primary analysis compared the mean weight for height Z score (WHZ) of children under 5 years in the intervention versus control tolas who attended for weight and height measurement 18 months after randomisation. Secondary outcomes were weight for age Z score (WAZ), height for age Z score, mid-upper arm circumference (MUAC), wasting, underweight and stunting.
RESULTS


We randomised 28 tolas to each arm and collected data from 2469 children (1560 mothers) at baseline and 2064 children (1326 mothers) at follow-up. WHZ was calculated for 1718 children at baseline and 1377 (674 intervention and 703 control) at follow-up. At 18 months, mean WHZ was significantly higher for intervention (-1.02) versus controls (-1.37; regression coefficient adjusted for clustering β = 0.38, 95% CI 0.16 to 0.61, p=0.001). Significantly fewer children were wasted in the intervention group (122, 18%) versus control (200, 29%; OR=0.46, 95% CI 0.28 to 0.74, p=0.002). Mean WAZ was better in the intervention group (-2.13 vs -2.37; β = 0.27, 95% CI 0.11 to 0.43, p=0.001) as was MUAC (13.6 cm vs 13.4 cm; β = 0.22, 95% CI 0.03 to 0.40, p=0.02). In an analysis adjusting for baseline nutritional measures (259 intervention children and 300 control), only WAZ and % underweight showed significant differences in favour of the intervention.
CONCLUSION


In marginalised communities in rural India, child nutrition was better in those who received Rojiroti microfinance, compared with controls.
TRIAL REGISTRATION NUMBER


NCT01845545.",2020,"In marginalised communities in rural India, child nutrition was better in those who received Rojiroti microfinance, compared with controls.
","['Tolas', 'village communities) in Bihar State', 'Rojiroti microfinance and child nutrition', 'Women and children under 5 years', '1718 children at baseline and 1377 (674 intervention and 703 control) at follow-up', '2469 children (1560 mothers) at baseline and 2064 children (1326 mothers) at follow-up', 'poor Indian women, improves child nutrition']","['WHZ', 'Rojiroti microfinance']","['weight for age Z score (WAZ), height for age Z score, mid-upper arm circumference (MUAC), wasting, underweight and stunting', 'mean WHZ', 'mean weight for height Z score (WHZ', 'Mean WAZ']","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1720755', 'cui_str': 'Child Nutritional Physiology Phenomena'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0424670', 'cui_str': 'Weight for height (observable entity)'}]",1326.0,0.187303,"In marginalised communities in rural India, child nutrition was better in those who received Rojiroti microfinance, compared with controls.
","[{'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Ojha', 'Affiliation': 'Division of Medical Sciences and Graduate Entry Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Szatkowski', 'Affiliation': 'Division of Epidemiology & Public Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Ranjeet', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Department of Community Medicine, Patna Medical College, Patna, Bihar, India.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Yaron', 'Affiliation': 'GY Associates Ltd and Trustee, Harpenden, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fogarty', 'Affiliation': 'Division of Epidemiology & Public Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Stephen John', 'Initials': 'SJ', 'LastName': 'Allen', 'Affiliation': 'Department of Child Health, The Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Choudhary', 'Affiliation': 'Centre for Promoting Sustainable Livelihood (CPSL), Patna, Bihar, India.'}, {'ForeName': 'Alan Robert', 'Initials': 'AR', 'LastName': 'Smyth', 'Affiliation': 'Division of Child Health, Obstetrics & Gynaecology, Nottingham University, Nottingham, UK alan.smyth@nottingham.ac.uk.'}]",Archives of disease in childhood,['10.1136/archdischild-2018-316471']
3309,31542145,Impact of Brief Nicotine Messaging on Nicotine-Related Beliefs in a U.S. Sample.,"INTRODUCTION


The current study pilot tested the effect of a single, brief exposure to nicotine education messages on beliefs about nicotine, nicotine-replacement therapy (NRT), E-cigarettes, and cigarettes with reduced nicotine content (RNC).
METHODS


Five hundred and twenty-one U.S. adults (aged ≥18 years) completed a 15-minute survey on Amazon Mechanical Turk in 2018. After completing items on sociodemographics, literacy, and cancer risk behaviors, participants were randomized in a 2:1:1 ratio to 1 of 3 conditions: nicotine education (n=263), sun safety education (attention control, n=128), or no message control (n=130). All participants completed items regarding nicotine, NRT, E-cigarette, and RNC cigarette beliefs, as well as norms about nicotine use, behavioral control regarding cigarette/tobacco use, and intention to use cigarettes, NRT, E-cigarettes, and RNC cigarettes in the next 12 months. Analyses were conducted in 2019.
RESULTS


Following exposure, nicotine education participants reported fewer false beliefs about nicotine (p<0.001), NRT (p<0.001), E-cigarettes (p<0.05), and RNC cigarettes (p<0.05) compared with the control conditions. Nicotine messaging doubled the probability of a correct response (false, 78.3% vs 36.8%) to nicotine is a cause of cancer and dramatically reduced the probability of responding don't know to this item (5.3% vs 26.0%). There was no impact of the intervention on beliefs about other substances within cigarette, norms, or behavioral intentions.
CONCLUSIONS


Findings from the current study support the hypothesis that a brief nicotine messaging intervention-similar to the messages likely to be seen on warning labels or in media campaigns-is likely to correct misperceptions of nicotine, NRT, E-cigarettes, and RNC cigarettes.",2019,"RESULTS


Following exposure, nicotine education participants reported fewer false beliefs about nicotine (p<0.001), NRT (p<0.001), E-cigarettes (p<0.05), and RNC cigarettes (p<0.05) compared with the control conditions.",['Five hundred and twenty-one U.S. adults (aged ≥18 years) completed a 15-minute survey on Amazon Mechanical Turk in 2018'],"['Nicotine messaging', 'nicotine', 'nicotine education (n=263), sun safety education (attention control, n=128), or no message control', 'nicotine, nicotine-replacement therapy (NRT), E-cigarettes, and cigarettes with reduced nicotine content (RNC', 'Brief Nicotine Messaging']","['sociodemographics, literacy, and cancer risk behaviors', 'nicotine, NRT, E-cigarette, and RNC cigarette beliefs', 'Nicotine-Related Beliefs', 'probability of a correct response', 'false beliefs about nicotine (p<0.001), NRT (p<0.001), E-cigarettes (p<0.05), and RNC cigarettes']","[{'cui': 'C4517803', 'cui_str': '520 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C1272340', 'cui_str': 'Safety education (procedure)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}]",,0.0338407,"RESULTS


Following exposure, nicotine education participants reported fewer false beliefs about nicotine (p<0.001), NRT (p<0.001), E-cigarettes (p<0.05), and RNC cigarettes (p<0.05) compared with the control conditions.","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Villanti', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont Larner College of Medicine, Burlington, Vermont. Electronic address: avillant@uvm.edu.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'West', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont Larner College of Medicine, Burlington, Vermont.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Department of Oncology, Georgetown University Medical Center, Cancer Prevention and Control Program, Lombardi Comprehensive Cancer Center, Washington, District of Columbia.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Cappella', 'Affiliation': 'Annenberg School for Communication at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Strasser', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.05.015']
3310,31601357,Group cognitive-behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations.,"BACKGROUND


Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive-behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists.
OBJECTIVES


To compare the clinical effectiveness and cost-effectiveness of a group CBT programme for RA fatigue [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive-behavioural (CB) approaches], delivered by the rheumatology team in addition to usual care (intervention), with usual care alone (control); and to evaluate tutors' experiences of the RAFT programme.
DESIGN


A randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of the seven centres. A nested qualitative evaluation was undertaken.
SETTING


Seven hospital rheumatology units in England and Wales.
PARTICIPANTS


Adults with RA and fatigue severity of ≥ 6 [out of 10, as measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS)] who had no recent changes in major RA medication/glucocorticoids.
INTERVENTIONS


RAFT - group CBT programme delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care - brief discussion of a RA fatigue self-management booklet with the research nurse.
MAIN OUTCOME MEASURES


Primary - fatigue impact (as measured by the BRAF-NRS) at 26 weeks. Secondary - fatigue severity/coping (as measured by the BRAF-NRS); broader fatigue impact [as measured by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)]; self-reported clinical status; quality of life; mood; self-efficacy; and satisfaction. All data were collected at weeks 0, 6, 26, 52, 78 and 104. In addition, fatigue data were collected at weeks 10 and 18. The intention-to-treat analysis conducted was blind to treatment allocation, and adjusted for baseline scores and centre. Cost-effectiveness was explored through the intervention and RA-related health and social care costs, allowing the calculation of quality-adjusted life-years (QALYs) with the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Tutor and focus group interviews were analysed using inductive thematic analysis.
RESULTS


A total of 308 out of 333 patients completed 26 weeks (RAFT,  n/N  = 156/175; control,  n/N  = 152/158). At 26 weeks, the mean BRAF-NRS impact was reduced for the RAFT programme (-1.36 units;  p  < 0.001) and the control interventions (-0.88 units;  p  < 0.004). Regression analysis showed a difference between treatment arms in favour of the RAFT programme [adjusted mean difference -0.59 units, 95% confidence interval (CI) -1.11 to -0.06 units;  p  = 0.03, effect size 0.36], and this was sustained over 2 years (-0.49 units, 95% CI -0.83 to -0.14 units;  p  = 0.01). At 26 weeks, further fatigue differences favoured the RAFT programme (BRAF-MDQ fatigue impact: adjusted mean difference -3.42 units, 95% CI -6.44 to - 0.39 units,  p  = 0.03; living with fatigue: adjusted mean difference -1.19 units, 95% CI -2.17 to -0.21 units,  p  = 0.02; and emotional fatigue: adjusted mean difference -0.91 units, 95% CI -1.58 to -0.23 units,  p  = 0.01), and these fatigue differences were sustained over 2 years. Self-efficacy favoured the RAFT programme at 26 weeks (Rheumatoid Arthritis Self-Efficacy Scale: adjusted mean difference 3.05 units, 95% CI 0.43 to 5.6 units;  p  = 0.02), as did BRAF-NRS coping over 2 years (adjusted mean difference 0.42 units, 95% CI 0.08 to 0.77 units;  p  = 0.02). Fatigue severity and other clinical outcomes were not different between trial arms and no harms were reported. Satisfaction with the RAFT programme was high, with 89% of patients scoring ≥ 8 out of 10, compared with 54% of patients in the control arm rating the booklet ( p  < 0.0001); and 96% of patients and 68% of patients recommending the RAFT programme and the booklet, respectively, to others ( p  < 0.001). There was no significant difference between arms for total societal costs including the RAFT programme training and delivery (mean difference £434, 95% CI -£389 to £1258), nor QALYs gained (mean difference 0.008, 95% CI -0.008 to 0.023). The probability of the RAFT programme being cost-effective was 28-35% at the National Institute for Health and Care Excellence's thresholds of £20,000-30,000 per QALY. Tutors felt that the RAFT programme's CB approaches challenged their usual problem-solving style, helped patients make life changes and improved tutors' wider clinical practice.
LIMITATIONS


Primary outcome data were missing for 25 patients; the EQ-5D-5L might not capture fatigue change; and 30% of the 2-year economic data were missing.
CONCLUSIONS


The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms. The RAFT programme is < 50% likely to be cost-effective; however, NHS costs were similar between treatment arms.
FUTURE WORK


Given the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN52709998.
FUNDING


This project was funded by the NIHR Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 57. See the NIHR Journals Library website for further project information.",2019,"The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms.","['Seven hospital rheumatology units in England and Wales', 'four consecutive cohorts within each of the seven centres', 'BRAF-NRS)] who had no recent changes in major RA medication/glucocorticoids', 'Adults with RA and fatigue severity of ≥\u20096 [out of 10, as measured by the', 'rheumatoid arthritis fatigue', 'A total of 308 out of 333 patients completed 26 weeks (RAFT,  n/N \u2009=\u2009156/175; control,  n/N \u2009=\u2009152/158']","['RAFT programme', 'RAFT - group CBT programme delivered by rheumatology tutor pairs (nurses/occupational therapists', 'usual care alone (control', 'EQ-5D-5L', 'cognitive-behavioural therapy (CBT', 'group CBT programme']","['fatigue data', 'emotional fatigue', 'RA fatigue impact', 'Cost-effectiveness', 'Self-efficacy', 'total societal costs', 'Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale', 'mean BRAF-NRS impact', 'Satisfaction', 'NHS costs', 'Fatigue severity', 'clinical effectiveness and cost-effectiveness', 'Secondary - fatigue severity/coping (as measured by the BRAF-NRS); broader fatigue impact [as measured by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)]; self-reported clinical status; quality of life; mood; self-efficacy; and satisfaction']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336849', 'cui_str': 'Raft, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0336849', 'cui_str': 'Raft, device (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",333.0,0.221487,"The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hewlett', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Almeida', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ambler', 'Affiliation': 'Pain Management Centre, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Department of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Choy', 'Affiliation': 'Section of Rheumatology, Division of Infection and Immunity, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dures', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hammond', 'Affiliation': 'Centre for Health Sciences Research, School of Health Sciences, University of Salford, Salford, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Department of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Bryar', 'Initials': 'B', 'LastName': 'Kadir', 'Affiliation': 'Department of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kirwan', 'Affiliation': 'Academic Rheumatology, Department of Translational Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Plummer', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Rooke', 'Affiliation': 'Patient Research Partner, Academic Rheumatology, Bristol Royal Infirmary, Bristol, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Thorn', 'Affiliation': 'Department of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Turner', 'Affiliation': 'Department of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Pollock', 'Affiliation': 'Department of Health and Social Sciences, University of the West of England Bristol, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23570']
3311,31622733,Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC.,"INTRODUCTION


In the phase 3 PACIFIC study of patients with unresectable stage III NSCLC without progression after chemoradiotherapy, durvalumab demonstrated significant improvements versus placebo in the primary end points of progression-free survival (hazard ratio [HR] = 0.52, 95% confidence interval [CI]: 0.42-65, p < 0.0001) and overall survival (OS) (HR = 0.68, 95% CI: 0.53-0.87, p = 0.00251), with manageable safety and no detrimental effect on patient-reported outcomes. Here, we report 3-year OS rates for all patients randomized in the PACIFIC study.
METHODS


Patients, stratified by age, sex, and smoking history, were randomized (2:1) to receive durvalumab, 10 mg/kg intravenously every 2 weeks, or placebo for up to 12 months. OS was analyzed by using a stratified log-rank test in the intention-to-treat population. Medians and rates at 12, 24, and 36 months were estimated by the Kaplan-Meier method.
RESULTS


As of January 31, 2019, 48.2% of patients had died (44.1% and 56.5% in the durvalumab and placebo groups, respectively). The median duration of follow-up was 33.3 months. The updated OS remained consistent with that previously reported (stratified HR = 0.69 [95% CI: 0.55-0.86]); the median OS was not reached with durvalumab but was 29.1 months with placebo. The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively. All secondary outcomes examined showed improvements consistent with previous analyses.
CONCLUSIONS


Updated OS data from PACIFIC, including 3-year survival rates, demonstrate the long-term clinical benefit with durvalumab after chemoradiotherapy and further establish the PACIFIC regimen as the standard of care in this population.",2020,"The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively.","['patients with unresectable, Stage III NSCLC without progression after chemoradiotherapy (CRT', 'Stage III NSCLC - Update from PACIFIC', 'Patients, stratified by age, sex and smoking history']","['placebo', 'durvalumab 10 mg/kg intravenously every 2 weeks or placebo', 'durvalumab and placebo', 'durvalumab after chemoradiotherapy']","['3-year OS rates', 'died', 'progression-free survival', 'median OS', 'overall survival', '3-year survival rates', 'Median duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.557291,"The 12-, 24- and 36-month OS rates with durvalumab and placebo were 83.1% versus 74.6%, 66.3% versus 55.3%, and 57.0% versus 43.5%, respectively.","[{'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. Electronic address: Jhanelle.Gray@moffitt.org.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Villegas', 'Affiliation': 'Cancer Specialists of North Florida, Jacksonville, Florida.'}, {'ForeName': 'Davey', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Tennessee Oncology, Chattanooga, Tennessee; Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'University Hospital Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Westmead Hospital, Sydney, New South Wales, Australia; University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Kansai Medical University Hospital, Hirakata, Japan.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Chiappori', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'University Hospital October 12, CiberOnc, Complutense University of Madrid, Madrid, Spain; National Cancer Research Center, Madrid, Spain.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'The University of Manchester and The Christie National Health Service Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Vansteenkiste', 'Affiliation': 'University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wadsworth', 'Affiliation': 'AstraZeneca, Alderley Park, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Taboada', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Dennis', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpasa, Cerrahpasa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.10.002']
3312,31099330,Gentamicin as an alternative to ceftriaxone in the treatment of gonorrhoea: the G-TOG non-inferiority RCT.,"BACKGROUND


Gonorrhoea is a common sexually transmitted infection that can cause pain and discomfort, affect fertility in women and lead to epididymo-orchitis in men. Current treatment is with ceftriaxone, but there is increasing evidence of antimicrobial resistance reducing its effectiveness. Gentamicin is a potential alternative treatment requiring further evaluation.
OBJECTIVES


To assess the clinical effectiveness and cost-effectiveness of gentamicin as an alternative treatment to ceftriaxone in the treatment of gonorrhoea.
DESIGN


A multicentre, parallel-group, blinded, non-inferiority randomised controlled trial.
SETTING


Fourteen sexual health clinics in England.
PARTICIPANTS


Adults aged 16-70 years with a diagnosis of uncomplicated, untreated genital, pharyngeal or rectal gonorrhoea based on a positive Gram-stained smear on microscopy or a positive nucleic acid amplification test (NAAT).
RANDOMISATION AND BLINDING


Participants were randomised using a secure web-based system, stratified by clinic. Participants, investigators and research staff assessing participants were blinded to treatment allocation.
INTERVENTIONS


Allocation was to either 240 mg of gentamicin (intervention) or 500 mg of ceftriaxone (standard treatment), both administered as a single intramuscular injection. All participants also received 1 g of oral azithromycin.
MAIN OUTCOME MEASURE


The primary outcome measure was clearance of  Neisseria gonorrhoeae  at all infected sites, confirmed by a negative Aptima Combo 2® (Hologic Inc., Marlborough, MA, USA) NAAT, at 2 weeks post treatment.
RESULTS


We randomised 720 participants, of whom 81% were men. There were 358 participants in the gentamicin group and 362 in the ceftriaxone group; 292 (82%) and 306 (85%) participants, respectively, were included in the primary analysis. Non-inferiority of gentamicin to ceftriaxone could not be demonstrated [adjusted risk difference for microbiological clearance -6.4%, 95% confidence interval (CI) -10.4% to -2.4%]. Clearance of genital infection was similar in the two groups, at 94% in the gentamicin group and 98% in the ceftriaxone group, but clearance of pharyngeal infection and rectal infection was lower in the gentamicin group (80% vs. 96% and 90% vs. 98%, respectively). Reported pain at the injection site was higher for gentamicin than for ceftriaxone. The side-effect profiles were comparable between the groups. Only one serious adverse event was reported and this was deemed not to be related to the trial medication. The economic analysis found that treatment with gentamicin is not cost neutral compared with standard care, with average patient treatment costs higher for those allocated to gentamicin (£13.90, 95% CI £2.47 to £37.34) than to ceftriaxone (£6.72, 95% CI £1.36 to £17.84).
LIMITATIONS


Loss to follow-up was 17% but was similar in both treatment arms. Twelve per cent of participants had a negative NAAT for gonorrhoea at their baseline visit but this was balanced between treatment groups and unlikely to have biased the trial results.
CONCLUSIONS


The trial was unable to demonstrate non-inferiority of gentamicin compared with ceftriaxone in the clearance of gonorrhoea at all infected sites. Clearance at pharyngeal and rectal sites was lower for participants allocated to gentamicin than for those allocated to ceftriaxone, but was similar for genital sites in both groups. Gentamicin was associated with more severe injection site pain. However, both gentamicin and ceftriaxone appeared to be well tolerated.
FUTURE WORK


Exploration of the genetic determinants of antibiotic resistance in  N. gonorrhoeae  will help to identify accurate markers of decreased susceptibility. Greater understanding of the immune response to infection can assist gonococcal vaccine development.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN51783227.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 20. See the NIHR Journals Library website for further project information.",2019,"Clearance at pharyngeal and rectal sites was lower for participants allocated to gentamicin than for those allocated to ceftriaxone, but was similar for genital sites in both groups.","['720 participants, of whom 81% were men', '358 participants in the gentamicin group and 362 in the ceftriaxone group; 292 (82%) and 306 (85%) participants, respectively, were included in the primary analysis', 'Adults aged 16-70 years with a diagnosis of uncomplicated, untreated genital, pharyngeal or rectal gonorrhoea based on a positive Gram-stained smear on microscopy or a positive nucleic acid amplification test (NAAT', 'women and lead to epididymo-orchitis in men', 'Fourteen sexual health clinics in England']","['gentamicin (intervention) or 500\u2009mg of ceftriaxone', 'gentamicin', 'azithromycin', 'Gentamicin', 'gentamicin and ceftriaxone', 'ceftriaxone']","['clearance of', 'pain', 'tolerated', 'severe injection site pain', 'clinical effectiveness and cost-effectiveness', 'Clearance of genital infection', 'Clearance at pharyngeal and rectal sites', 'clearance of pharyngeal infection and rectal infection']","[{'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0275665', 'cui_str': 'Gonorrhea of rectum (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0061856', 'cui_str': ""Gram's stain""}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0026018', 'cui_str': 'Microscopy'}, {'cui': 'C0200932', 'cui_str': 'Nucleic Acid Amplification Tests'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0149881', 'cui_str': 'Epididymo-orchitis'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0017436', 'cui_str': 'Gentamicins'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0729552', 'cui_str': 'Infectious disease of genitopelvic system'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",720.0,0.257692,"Clearance at pharyngeal and rectal sites was lower for participants allocated to gentamicin than for those allocated to ceftriaxone, but was similar for genital sites in both groups.","[{'ForeName': 'Jonathan Dc', 'Initials': 'JD', 'LastName': 'Ross', 'Affiliation': 'Whittall Street Clinic, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Harding', 'Affiliation': 'Whittall Street Clinic, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Lelia', 'Initials': 'L', 'LastName': 'Duley', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Montgomery', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Hepburn', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Brittain', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Meakin', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Sprange', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Sukhwinder', 'Initials': 'S', 'LastName': 'Thandi', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jackson', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Roberts', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'Leeds Centre for Sexual Health, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'White', 'Affiliation': ""Burrell Street Clinic, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dewsnap', 'Affiliation': 'Sheffield Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cole', 'Affiliation': 'Antimicrobial Resistance and Healthcare Associated Infections (AMRHAI), National Infection Service, Public Health England, London, UK.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Lawrence', 'Affiliation': 'Whittall Street Clinic, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23200']
3313,30689757,Effectiveness of Seasonal Influenza Vaccination in Children in Senegal During a Year of Vaccine Mismatch: A Cluster-randomized Trial.,"BACKGROUND


The population effects of influenza vaccination in children have not been extensively studied, especially in tropical, developing countries. In rural Senegal, we assessed the total (primary objective) and indirect effectiveness of a trivalent inactivated influenza vaccine (IIV3).
METHODS


In this double-blind, cluster-randomized trial, villages were randomly allocated (1:1) for the high-coverage vaccination of children aged 6 months through 10 years with either the 2008-09 northern hemisphere IIV3 or an inactivated polio vaccine (IPV). Vaccinees were monitored for serious adverse events. All village residents, vaccinated and unvaccinated, were monitored for signs and symptoms of influenza illness using weekly home visits and surveillance in designated clinics. The primary outcome was all laboratory-confirmed symptomatic influenza.
RESULTS


Between 23 May and 11 July 2009, 20 villages were randomized, and 66.5% of age-eligible children were enrolled (3918 in IIV3 villages and 3848 in IPV villages). Follow-up continued until 28 May 2010. There were 4 unrelated serious adverse events identified. Among vaccinees, the total effectiveness against illness caused by the seasonal influenza virus (presumed to all be drifted A/H3N2, based on antigenic characterization data) circulating at high rates among children was 43.6% (95% confidence interval [CI] 18.6-60.9%). The indirect effectiveness against seasonal A/H3N2 was 15.4% (95% CI -22.0 to 41.3%). The total effectiveness against illness caused by the pandemic influenza virus (A/H1N1pdm09) was -52.1% (95% CI -177.2 to 16.6%).
CONCLUSIONS


IIV3 provided statistically significant, moderate protection to children in Senegal against circulating, pre-2010 seasonal influenza strains, but not against A/H1N1pdm09, which was not included in the vaccine. No indirect effects were measured. Further study in low-resource populations is warranted.
CLINICAL TRIALS REGISTRATION


NCT00893906.",2019,"IIV3 provided statistically significant, moderate protection to children in Senegal against circulating pre-2010 seasonal influenza strains but not against A/H1N1pdm09 not included in the vaccine.","['Between May 23 and July 11, 2009, 20 villages were randomized, and 66.5% of age-eligible children were enrolled (3918 in IIV3 villages and 3848 in IPV villages', 'children aged 6 months through 10 years with 2008-09 northern hemisphere IIV3 or', 'children in Senegal during a year of vaccine mismatch']","['seasonal influenza vaccination', 'inactivated polio vaccine (IPV', 'inactivated influenza vaccine, trivalent (IIV3']","['laboratory-confirmed symptomatic influenza', 'Indirect effectiveness against seasonal A/H3N2', 'Total effectiveness against illness']","[{'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036644', 'cui_str': 'Republic of Senegal'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course (qualifier value)'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]",20.0,0.338471,"IIV3 provided statistically significant, moderate protection to children in Senegal against circulating pre-2010 seasonal influenza strains but not against A/H1N1pdm09 not included in the vaccine.","[{'ForeName': 'Aldiouma', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Ousmane M', 'Initials': 'OM', 'LastName': 'Diop', 'Affiliation': 'Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Doudou', 'Initials': 'D', 'LastName': 'Diop', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Mbayame Nd', 'Initials': 'MN', 'LastName': 'Niang', 'Affiliation': 'Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Sugimoto', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'Center for Vaccine Development, University of Maryland, Baltimore.'}, {'ForeName': 'El Hadji Abdourahmane', 'Initials': 'EHA', 'LastName': 'Faye', 'Affiliation': 'Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Bou', 'Initials': 'B', 'LastName': 'Diarra', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Goudiaby', 'Affiliation': 'Institut Pasteur de Dakar, Senegal.'}, {'ForeName': 'Kristen D C', 'Initials': 'KDC', 'LastName': 'Lewis', 'Affiliation': 'PATH, Seattle, Washington.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Emery', 'Affiliation': 'Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Sahar Z', 'Initials': 'SZ', 'LastName': 'Zangeneh', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lafond', 'Affiliation': 'Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Cheikh', 'Initials': 'C', 'LastName': 'Sokhna', 'Affiliation': 'UMR VITROME, Institut de Recherche Pour le Développement, Dakar, Senegal.'}, {'ForeName': 'M Elizabeth', 'Initials': 'ME', 'LastName': 'Halloran', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Marc-Alain', 'Initials': 'MA', 'LastName': 'Widdowson', 'Affiliation': 'Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development, University of Maryland, Baltimore.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'PATH, Seattle, Washington.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz066']
3314,32118739,"Effect of subcutaneous needling on visual analogue scale, IgG and IgM in patients with lumbar disc herniation: Study protocol clinical trial (SPIRIT Compliant).","BACKGROUND


Lumbar disc herniation (LDH) is a disease commonly seen in clinical practice. In the majority of such patients presenting in clinic, the symptoms can be relieved or even abolished after non-surgical treatment. Floating needle therapy has attracted considerable attention as a promising non-surgical technique to treat LDH, as demonstrated in previous studies. The purpose of the present study was to evaluate the outcomes of patients treated using this therapy in a single blind and randomized controlled trial by recording patient report questionnaires and objective test data, and to explore the feasibility and preliminary effects of floating needle therapy for patients with LDH.
METHODS


A total of 80 patients who fulfilled the inclusion criteria were randomly divided into a Fu's subcutaneous needling (FSN) group and an acupuncture group then treated in accordance with procedures appropriate for a single blind and randomized controlled trial. The FSN group received 12 FSN therapy sessions over a 3-week period, and the acupuncture group received acupuncture therapy at specified points using acupuncture needles. The principal measurements were scored using the visual analogue scale (VAS), Japanese Orthopedic Association (JOA) Score, and Oswestry disability index (ODI) before and 3 weeks after treatment. Secondary measurements included immune function IgG and IgM measurements performed at the same time and adverse reactions during treatment.
RESULTS


The results of this trial will be published on the website of China Clinical Trial Registration Center (http://www.chictr.org.cn/searchprojen.aspx) and in peer-reviewed journals or academic conferences.
CONCLUSIONS


This study will explore the feasibility and preliminary effects of floating needle therapy for the treatment of patients with LDH.
REGISTRATION


PROSPERO (registration number ChiCTR1900024045).",2020,A total of 80 patients who fulfilled the inclusion criteria were randomly divided into a Fu's subcutaneous needling (FSN) group and an acupuncture group then treated in accordance with procedures appropriate for a single blind and randomized controlled trial.,"['80 patients who fulfilled the inclusion criteria', 'patients with LDH', 'patients with lumbar disc herniation']","['acupuncture', 'acupuncture needles', 'floating needle therapy', 'Floating needle therapy', 'acupuncture group received acupuncture therapy', ""Fu's subcutaneous needling (FSN"", 'subcutaneous needling']","['visual analogue scale (VAS), Japanese Orthopedic Association (JOA) Score, and Oswestry disability index (ODI', 'immune function IgG and IgM measurements performed at the same time and adverse reactions', 'visual analogue scale, IgG and IgM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc (disorder)'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle, device (physical object)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",80.0,0.0967971,A total of 80 patients who fulfilled the inclusion criteria were randomly divided into a Fu's subcutaneous needling (FSN) group and an acupuncture group then treated in accordance with procedures appropriate for a single blind and randomized controlled trial.,"[{'ForeName': 'Jiangxia', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Xingzhang', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Gansu Provincial People's Hospital, Lanzhou, Gansu, China.""}, {'ForeName': 'Xingyong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Gansu Provincial People's Hospital, Lanzhou, Gansu, China.""}]",Medicine,['10.1097/MD.0000000000019280']
3315,31113531,Anal fistula plug versus surgeon's preference for surgery for trans-sphincteric anal fistula: the FIAT RCT.,"BACKGROUND


The aim of fistula surgery is to eradicate the disease while preserving anal sphincter function. The efficacy of the Surgisis ®  anal fistula plug (Cook Medical, Bloomington, IN, USA) in the treatment of trans-sphincteric fistula-in-ano has been variably reported.
OBJECTIVES


To undertake a randomised comparison of the safety and efficacy of the Surgisis anal fistula plug in comparison with surgeon's preference for the treatment of trans-sphincteric anal fistulas.
DESIGN


A randomised, unblinded, parallel-arm, prospective, multicentre clinical trial.
SETTING


Hospitals in the UK NHS involving colorectal surgeons accredited by the Association of Coloproctology of Great Britain and Ireland.
PARTICIPANTS


Adult patients suffering from trans-sphincteric fistula-in-ano of cryptoglandular origin.
INTERVENTIONS


Patients were randomised on a 1 : 1 basis to either the fistula plug or the surgeon's preference [e.g. fistulotomy, cutting seton, advancement flap or ligation of intersphincteric fistula tract (LIFT) procedure].
MAIN OUTCOME MEASURES


The primary outcome measure was quality of life as measured by the Faecal Incontinence Quality of Life (FIQoL) questionnaire at 12-month follow-up. Secondary outcome measures included clinical and radiological fistula healing rates, faecal incontinence rates, complications rates, reintervention rates and cost-effectiveness.
RESULTS


Between May 2011 and March 2016, 304 participants were recruited (152 fistula plug vs. 152 surgeon's preference). No difference in FIQoL score between the two trial groups was seen at the 6-week, 6-month or 12-month follow-up. Clinical evidence of fistula healing was reported in 66 of 122 (54%) participants in the fistula plug group and in 66 of 119 (55%) participants in the surgeon's preference group at 12 months. Magnetic resonance imaging (MRI) showed fistula healing in 54 of 110 (49%) participants in the fistula plug group and in 63 of 112 (56%) participants in the surgeon's preference group. Variation in 12-month clinical healing rates was observed: 55%, 64%, 75%, 53% and 42% for fistula plug, cutting seton, fistulotomy, advancement flap and LIFT procedure, respectively. Faecal incontinence rates were low at baseline, with small improvement in both groups post treatment. Complications and reinterventions were frequent. The mean total costs were £2738 [standard deviation (SD) £1151] in the fistula plug group and £2308 (SD £1228) in the surgeon's preference group. The average total quality-adjusted life-years (QALYs) gain was much smaller in the fistula plug group (0.829, SD 0.174) than in the surgeon's preference group (0.790, SD 0.212). Using multiple imputation and probabilistic sensitivity analysis, and adjusting for differences in baseline EuroQol-5 Dimensions, three-level version utility, there was a 35-45% chance that the fistula plug was as cost-effective as surgeon's preference over a range of thresholds of willingness to pay for a single QALY of £20,000-30,000.
LIMITATIONS


Limitations include a smaller sample size than originally calculated, a lack of blinding that perhaps biased patient-reported outcomes and a lower compliance rate with MRI at 12-month follow-up.
CONCLUSIONS


The Surgisis anal fistula plug is associated with similar FIQoL score to surgeon's preference at 12-month follow-up. The higher costs and highly uncertain and small gains in QALYs associated with the fistula plug mean that this technology is unlikely to be considered a cost-effective use of resources in the UK NHS.
FUTURE WORK


Further in-depth analysis should consider the clinical and MRI characteristics of fistula-in-ano in an attempt to identify predictors of fistula response to treatment.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN78352529.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 21. See the NIHR Journals Library website for further project information.",2019,Magnetic resonance imaging (MRI) showed fistula healing in 54 of 110 (49%) participants in the fistula plug group and in 63 of 112 (56%) participants in the surgeon's preference group.,"['Adult patients suffering from trans-sphincteric fistula-in-ano of cryptoglandular origin', ""54 of 110 (49%) participants in the fistula plug group and in 63 of 112 (56%) participants in the surgeon's preference group"", 'Hospitals in the UK NHS', ""Between May 2011 and March 2016, 304 participants were recruited (152 fistula plug vs. 152 surgeon's preference"", 'trans-sphincteric anal fistulas']","[""Anal fistula plug versus surgeon's preference"", 'Surgisis ®  anal fistula plug (Cook Medical, Bloomington, IN, USA', 'Magnetic resonance imaging (MRI', ""fistula plug or the surgeon's preference [e.g. fistulotomy, cutting seton, advancement flap or ligation of intersphincteric fistula tract (LIFT) procedure"", 'Surgisis anal fistula plug']","['safety and efficacy', 'fistula healing', 'quality of life as measured by the Faecal Incontinence Quality of Life (FIQoL) questionnaire', 'average total quality-adjusted life-years (QALYs) gain', 'Faecal incontinence rates', 'mean total costs', 'clinical and radiological fistula healing rates, faecal incontinence rates, complications rates, reintervention rates and cost-effectiveness', 'Complications and reinterventions', 'FIQoL score', 'clinical healing rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205929', 'cui_str': 'Anal Fistula'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0182324', 'cui_str': 'Plug (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0205929', 'cui_str': 'Anal Fistula'}, {'cui': 'C0182324', 'cui_str': 'Plug (physical object)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C3850276', 'cui_str': 'surgisis'}, {'cui': 'C1306756', 'cui_str': 'Cook (occupation)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0744044', 'cui_str': 'Fistulotomy'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0341379', 'cui_str': 'Intersphincteric fistula (disorder)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",304.0,0.0824145,Magnetic resonance imaging (MRI) showed fistula healing in 54 of 110 (49%) participants in the fistula plug group and in 63 of 112 (56%) participants in the surgeon's preference group.,"[{'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Jayne', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Scholefield', 'Affiliation': 'Department of Surgery, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Tolan', 'Affiliation': ""Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population Health Medicine Sciences Division, University of Oxford, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Edlin', 'Affiliation': 'Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Claire T', 'Initials': 'CT', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sutton', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Handley', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Hewitt', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Manjinder', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Magill', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23210']
3316,32147060,"The effect of fenugreek seed supplementation on serum irisin levels, blood pressure, and liver and kidney function in patients with type 2 diabetes mellitus: A parallel randomized clinical trial.","OBJECTIVES


This study was designed to determine the effects of fenugreek seed (FS) on serum irisin levels, blood pressure, and liver and kidney function in patients with type 2 diabetes mellitus (T2DM).
METHODS


In an 8-week randomized controlled clinical trial, T2DM patients (n = 50) were assigned to the intervention (5 g FS powder, 3 times a day) or control group. Both groups received anti-diabetic drugs and nutritional consults. Serum samples were collected and blood pressure was measured at baseline and end of the trial. Data on dietary intake and physical activity was determined using the questionnaires.
RESULTS


Compared to the control group, FS consumption resulted in a significant decrease in fasting plasma glucose (FPG) (p = 0.024), as well as a significant change in serum alanine aminotransferase (ALT) (p = 0.02) and alkaline phosphatase (ALP) (p = 0.001). Within-group analysis showed a significant decrease in aspartate aminotransferase (AST) (p = 0.014), systolic blood pressure (SBP) (p = 0.001), and irisin (p = 0.001) in the FS group, and a significant increase in creatinine (Cr) (p = 0.001) and decrease in estimated glomerular filtration rate (eGFR) (p = 0.001) in the control group. FS consumption did not have any significant effect on diastolic blood pressure (DBP) and blood urea nitrogen (BUN).
CONCLUSION


FS intake has some beneficial effects on FPG, SBP, and some liver and kidney function tests in patients with T2DM. Further studies are required to investigate the effect of FS on irisin levels. Trial registration number http://www.irct.ir, code: IRCT20190618043924N1.",2020,"Within-group analysis showed a significant decrease in aspartate aminotransferase (AST) (p = 0.014), systolic blood pressure (SBP) (p = 0.001), and irisin (p = 0.001) in the FS group, and a significant increase in creatinine (Cr) (p = 0.001) and decrease in estimated glomerular filtration rate (eGFR) (p = 0.001) in the control group.","['T2DM patients (n = 50', 'patients with T2DM', 'patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['fenugreek seed (FS', 'fenugreek seed supplementation', 'anti-diabetic drugs and nutritional consults']","['diastolic blood pressure (DBP) and blood urea nitrogen (BUN', 'fasting plasma glucose (FPG', 'dietary intake and physical activity', 'serum alanine aminotransferase (ALT', 'creatinine (Cr', 'aspartate aminotransferase (AST', 'blood pressure', 'systolic blood pressure (SBP', 'serum irisin levels, blood pressure, and liver and kidney function', 'estimated glomerular filtration rate (eGFR', 'alkaline phosphatase (ALP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0453257', 'cui_str': 'Fenugreek seed (substance)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3811844'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}]",50.0,0.0391405,"Within-group analysis showed a significant decrease in aspartate aminotransferase (AST) (p = 0.014), systolic blood pressure (SBP) (p = 0.001), and irisin (p = 0.001) in the FS group, and a significant increase in creatinine (Cr) (p = 0.001) and decrease in estimated glomerular filtration rate (eGFR) (p = 0.001) in the control group.","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hadi', 'Affiliation': 'Halal Research Center of IRI, FDA, Tehran, Iran. Electronic address: amirhadi.vnt@gmail.com.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Arab', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Science, Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: arman4369@gmail.com.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Hajianfar', 'Affiliation': 'Food Safety Research Center (salt), Semnan University of Medical Sciences, Semnan, Iran. Electronic address: hossein_hajian2005@yahoo.com.'}, {'ForeName': 'Behrouz', 'Initials': 'B', 'LastName': 'Talaei', 'Affiliation': 'Department of Nutrition, School of Health, Kerman University of Medical Sciences, Kerman, Iran; Physiology Research Center, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: b.talaei@kmu.ac.ir.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Miraghajani', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran; The Early Life Research Unit, Academic Division of Child Health, Obstetrics and Gynaecology and Nottingham Digestive Disease Centre and Biomedical Research Centre, The School of Medicine, University of Nottingham, Nottingham, NG7 2UH, UK. Electronic address: ms.miraghajani@yahoo.com.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Babajafari', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: jafaris@sums.ac.ir.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Marx', 'Affiliation': 'Deakin University, iMPACT, School of Medicine, Geelong, Australia. Electronic address: wolf.marx@deakin.edu.au.'}, {'ForeName': 'Rahele', 'Initials': 'R', 'LastName': 'Tavakoly', 'Affiliation': 'Student Research Committee, School of Health, Kerman University of Medical Sciences, Kerman, Iran; Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: tavakkoli.rahele@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102315']
3317,32147084,"The effect of eurhythmy therapy on self-determination, health complaints and psychological symptoms: A non-randomised trial.","OBJECTIVES


To study healthcare quality improvement through Eurhythmy Therapy (EYT) relative to treatment as usual without EYT.
DESIGN


Pre/post-follow-up analysis with a comparison group.
SETTING


Patients of 13 eurhythmy therapists and people with similar physical or psychological health complaints. Respondents' mean age was 60 years (SD = 13.83).
INTERVENTION


EYT-sessions for the complaint versus treatment as usual.
OUTCOME MEASURES


Self-determination (BPNSFS); health complaint (1 item); sleeping problems (SCL-90); psychological symptoms and work/study dysfunction (SQ-48) at pre-measure (t0), post-measure (t1) and one-month follow-up (t2).
RESULTS


A small positive effect of EYT on self-determination (eta 2  = .08) and a medium negative effect of EYT on health complaints at t1 and t2 (η 2 p  = .24 and .22). The effect of EYT was n.s. on sleeping problems, n.s. on psychological symptoms and medium negative n.s. on work/study dysfunction, the last within a small sample size (n < 30; eta 2  = .13).
CONCLUSIONS


EYT-participants (n = 38) improved more on self-determination, health complaints and probably also on work/study dysfunction than the comparison group (n = 42), but not on sleeping problems and psychological symptoms. Results should be treated with caution, because the comparison group is not comparable to the EYT-group in the motivation to engage in EYT and the sample size was small.",2020,"CONCLUSIONS


EYT-participants (n = 38) improved more on self-determination, health complaints and probably also on work/study dysfunction than the comparison group (n = 42), but not on sleeping problems and psychological symptoms.","[""Respondents' mean age was 60 years (SD = 13.83"", 'Patients of 13 eurhythmy therapists and people with similar physical or psychological health complaints']","['Eurhythmy Therapy (EYT', 'eurhythmy therapy']","['sleeping problems and psychological symptoms', 'self-determination, health complaints', 'health complaints', 'self-determination, health complaints and psychological symptoms', 'Self-determination (BPNSFS); health complaint (1 item); sleeping problems (SCL-90); psychological symptoms and work/study dysfunction (SQ-48) at pre-measure (t0), post-measure (t1) and one-month follow-up (t2']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.0427392,"CONCLUSIONS


EYT-participants (n = 38) improved more on self-determination, health complaints and probably also on work/study dysfunction than the comparison group (n = 42), but not on sleeping problems and psychological symptoms.","[{'ForeName': 'Roelien', 'Initials': 'R', 'LastName': 'Logtenberg', 'Affiliation': 'Department of Life-Span Psychology (master thesis), Open University, Vuile Riete 42, 7925PM, Linde, the Netherlands. Electronic address: Roelien.Logtenberg@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102347']
3318,32046499,"App-based mindfulness meditation for psychological distress and adjustment to college in incoming university students: a pragmatic, randomised, waitlist-controlled trial.","Objective and Design:  In a pragmatic, randomised, waitlist-controlled trial we tracked 250 first-year university students who were randomly assigned to 3 months of a mindfulness meditation app (Headspace) to use at their discretion in either semester 1 (intervention,  n  = 124) or semester 2 (waitlist,  n  = 126).  Main Outcome Measures:  Students reported their distress, college adjustment, resilience, self-efficacy, and mindfulness, at 3 timepoints: the beginning of semester 1, the beginning of semester 2, and the end of the academic year. With participants' permission, the university provided academic achievement data and Headspace provided app use data.  Results:  Evidence for improvements in distress at the beginning of semester 2 was weak (intervention vs. waitlist) and app use was low ( M  = 7.91, SD = 15.16 sessions). Nevertheless, intervention participants who used the app more frequently reported improvements in psychological distress (-5 points, R 2  change = .12) and college adjustment (+10 points, R 2  change = .09) when compared to non-users. App initiation and persistence beyond the first week was higher when the app was provided in semester 1 than semester 2 (66.1% vs. 44.4%; 46.0% vs. 32.5%).  Conclusion:  Headspace use was associated with small improvements in distress and college adjustment in first-year university students. Intervening at the beginning of the academic year may encourage uptake.",2020,"Nevertheless, intervention participants who used the app more frequently reported improvements in psychological distress (-5 points, R 2  change = .12) and college adjustment (+10 points, R 2  change = .09) when compared to non-users.","['psychological distress and adjustment to college in incoming university students', '250 first-year university students']","['App-based mindfulness meditation', 'mindfulness meditation app (Headspace) to use at their discretion in either semester 1 (intervention,  n \u2009=\u2009124) or semester 2 (waitlist,  n \u2009=\u2009126']","['psychological distress', 'distress, college adjustment, resilience, self-efficacy, and mindfulness', 'distress']","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]",250.0,0.0485816,"Nevertheless, intervention participants who used the app more frequently reported improvements in psychological distress (-5 points, R 2  change = .12) and college adjustment (+10 points, R 2  change = .09) when compared to non-users.","[{'ForeName': 'Jayde A M', 'Initials': 'JAM', 'LastName': 'Flett', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tamlin S', 'Initials': 'TS', 'LastName': 'Conner', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Riordan', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Patterson', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Harlene', 'Initials': 'H', 'LastName': 'Hayne', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}]",Psychology & health,['10.1080/08870446.2019.1711089']
3319,31300183,Effectiveness of a health belief model intervention using a lay health advisor strategy on mouth self-examination and cancer screening in remote aboriginal communities: A randomized controlled trial.,"OBJECTIVE


Oral cancers caused by chewing betel nuts have a poor prognosis. Using a lay health advisor (LHA) can increase access to health care among underprivileged populations. This study evaluated a health belief model (HBM) intervention using LHAs for oral cancer screening (OCS) and mouth self-examination (MSE) in remote aboriginal communities.
METHODS


The participants were randomly assigned to intervention (IG; n = 171) and control groups (CG; n = 176). In the IG, participants received a three-chapter one-on-one teaching course from LHAs, whereas those in the CG received only a leaflet.
RESULTS


The IG participants were 2.04 times more likely to conduct a monthly MSE than those in the CG (95% confidence interval: 1.31-3.17) and showed significantly higher self-efficacy levels toward OSC and MSE (β = 0.53 and 0.44, effect size = 0.33 and 0.25, respectively) and a lower barrier level for OSC (β = -1.81, effect size = -0.24).
CONCLUSION


The LHA intervention had a significantly positive effect on MSE, strengthening self-efficacy and reducing barriers to OCS among aboriginal populations.
PRACTICE IMPLICATIONS


The effectiveness of the clinical treatment of underprivileged group can be improved through early diagnosis, which can be achieved using LHAs to reduce barriers to OSC.",2019,"The LHA intervention had a significantly positive effect on MSE, strengthening self-efficacy and reducing barriers to OCS among aboriginal populations.
",['remote aboriginal communities'],"['lay health advisor (LHA', 'LHA intervention', 'health belief model (HBM) intervention using LHAs for oral cancer screening (OCS) and mouth self-examination (MSE', 'health belief model intervention']","['mouth self-examination and cancer screening', 'lower barrier level for OSC', 'self-efficacy levels toward OSC and MSE ', 'MSE, strengthening self-efficacy and reducing barriers to OCS']","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}, {'cui': 'C0153381', 'cui_str': 'Cancer of Mouth'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0080142', 'cui_str': 'Self-Examination'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0080142', 'cui_str': 'Self-Examination'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",,0.0421696,"The LHA intervention had a significantly positive effect on MSE, strengthening self-efficacy and reducing barriers to OCS among aboriginal populations.
","[{'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'School of Dentistry, College of Dental Medicine, Kaohsiung Medical University, Taiwan. No. 100 Shih-Chuan 1st Road, 80708, Kaohsiung, Taiwan; Department of Oral Hygiene and Healthcare, Cardinal Tien Junior College of Healthcare and Management, Taiwan. No. 112, Minzu Rd., 23143, New Taipei City, Taiwan. Electronic address: leeheng@ctcn.edu.tw.'}, {'ForeName': 'Pei-Shan', 'Initials': 'PS', 'LastName': 'Ho', 'Affiliation': 'Department of Oral Hygiene, College of Dental Medicine, Kaohsiung Medical University, Taiwan. No. 100 Shih-Chuan 1st Road, 80708, Kaohsiung, Taiwan. Electronic address: psho@kmu.edu.tw.'}, {'ForeName': 'Wen-Chen', 'Initials': 'WC', 'LastName': 'Wang', 'Affiliation': 'School of Dentistry, College of Dental Medicine, Kaohsiung Medical University, Taiwan. No. 100 Shih-Chuan 1st Road, 80708, Kaohsiung, Taiwan. Electronic address: wcwang@kmu.edu.tw.'}, {'ForeName': 'Chih-Yang', 'Initials': 'CY', 'LastName': 'Hu', 'Affiliation': 'School of Public Health, Health Sciences Center, Louisiana State University, U.S.A. 2020 Gravier Street 3F, New Orleans, LA, USA. Electronic address: chu@lsuhsc.edu.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health, College of Health Sciences and Research Center for Environmental Medicine, Kaohsiung Medical University, Taiwan. No. 100 Shih-Chuan 1st Road, 80708, Kaohsiung, Taiwan. Electronic address: Cnhung@kmu.edu.tw.'}, {'ForeName': 'Hsiao-Ling', 'Initials': 'HL', 'LastName': 'Huang', 'Affiliation': 'Department of Oral Hygiene, College of Dental Medicine, Kaohsiung Medical University, Taiwan. No. 100 Shih-Chuan 1st Road, 80708, Kaohsiung, Taiwan. Electronic address: hhuang@kmu.edu.tw.'}]",Patient education and counseling,['10.1016/j.pec.2019.07.001']
3320,31691827,Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea.,"STUDY OBJECTIVES


To evaluate long-term safety and maintenance of efficacy of solriamfetol treatment for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea (OSA).
METHODS


Participants with narcolepsy or OSA who completed a prior solriamfetol study were eligible. A 2-week titration period was followed by a maintenance phase (up to 50 weeks). Efficacy was assessed by Epworth Sleepiness Scale (ESS) and Patient and Clinical Global Impression of Change (PGI-C and CGI-C, respectively). After approximately 6 months of treatment, a subgroup entered a 2-week placebo-controlled randomized withdrawal (RW) phase. Change in ESS from beginning to end of the RW phase was the primary endpoint; PGI-C and CGI-C were secondary endpoints. Safety was assessed throughout the study.
RESULTS


In the maintenance phase, solriamfetol-treated participants demonstrated clinically meaningful improvements on ESS, PGI-C, and CGI-C. In the RW phase, least squares mean change on ESS was 1.6 in participants continuing solriamfetol versus 5.3 in participants switched to placebo (p < .0001). For both secondary endpoints, higher percentages of participants receiving placebo were reported as worse at the end of the RW phase versus solriamfetol (p < .0001). Common treatment-emergent adverse events (TEAEs) with solriamfetol were headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection; 27 (4.2%) participants experienced at least one serious TEAE, and 61 (9.5%) withdrew because of TEAEs.
CONCLUSIONS


This study demonstrated long-term maintenance of efficacy of solriamfetol under open-label and double-blind, placebo-controlled conditions. Safety profile of solriamfetol was consistent with previous 12-week studies; no new safety concerns were identified.
TRIAL REGISTRATION


NCT02348632.",2020,"Safety profile of solriamfetol was consistent with previous 12-week studies; no new safety concerns were identified.
","['excessive daytime sleepiness in narcolepsy and obstructive sleep apnea (OSA', 'Participants with narcolepsy or OSA who completed a prior solriamfetol study were eligible', 'participants with narcolepsy or obstructive sleep apnea']","['placebo', 'solriamfetol under open-label and double-blind, placebo', 'solriamfetol (JZP-110', 'solriamfetol treatment']","['ESS', 'Safety', 'excessive sleepiness', 'Epworth Sleepiness Scale (ESS) and Patient and Clinical Global Impression of Change (PGI-C and CGI-C, respectively', 'Efficacy', 'ESS, PGI-C, and CGI-C', 'headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection']","[{'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0027404', 'cui_str': 'Narcoleptic Syndrome'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4547387', 'cui_str': 'JZP-110'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}]",,0.151496,"Safety profile of solriamfetol was consistent with previous 12-week studies; no new safety concerns were identified.
","[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, La Jolla.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Shapiro', 'Affiliation': 'University of Toronto, ON, Canada.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pepin', 'Affiliation': 'HP2 Laboratory, INSERM U1042, University Grenoble Alpes, France.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg University, Sweden.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Cleveland Sleep Research Center, OH.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Foldvary-Schaefer', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, OH.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Strollo', 'Affiliation': 'University of Pittsburgh/Veterans Administration Pittsburgh Health System, PA.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Mayer', 'Affiliation': 'Hephata Klinik, Schwalmstadt, Germany.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sarmiento', 'Affiliation': 'San Francisco Veterans Administration Healthcare System, CA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Baladi', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Chandler', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwab', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}]",Sleep,['10.1093/sleep/zsz220']
3321,31577219,Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation for heavy menstrual bleeding: the HEALTH RCT.,"BACKGROUND


Heavy menstrual bleeding (HMB) is a common problem that affects many British women. When initial medical treatment is unsuccessful, the National Institute for Health and Care Excellence recommends surgical options such as endometrial ablation (EA) or hysterectomy. Although clinically and economically more effective than EA, total hysterectomy necessitates a longer hospital stay and is associated with slower recovery and a higher risk of complications. Improvements in endoscopic equipment and training have made laparoscopic supracervical hysterectomy (LASH) accessible to most gynaecologists. This operation could preserve the advantages of total hysterectomy and reduce the risk of complications.
OBJECTIVES


To compare the clinical effectiveness and cost-effectiveness of LASH with second-generation EA in women with HMB.
DESIGN


A parallel-group, multicentre, randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio). Surgeons and participants were not blinded to the allocated procedure.
SETTING


Thirty-one UK secondary and tertiary hospitals.
PARTICIPANTS


Women aged < 50 years with HMB. Exclusion criteria included plans to conceive; endometrial atypia; abnormal cytology; uterine cavity size > 11 cm; any fibroids > 3 cm; contraindications to laparoscopic surgery; previous EA; and inability to give informed consent or complete trial paperwork.
INTERVENTIONS


LASH compared with second-generation EA.
MAIN OUTCOME MEASURES


Co-primary clinical outcome measures were (1) patient satisfaction and (2) Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS) score at 15 months post randomisation. The primary economic outcome was incremental cost (NHS perspective) per quality-adjusted life-year (QALY) gained.
RESULTS


A total of 330 participants were randomised to each group (total  n  = 660). Women randomised to LASH were more likely to be satisfied with their treatment than those randomised to EA (97.1% vs. 87.1%) [adjusted difference in proportions 0.10, 95% confidence interval (CI) 0.05 to 0.15; adjusted odds ratio (OR) from ordinal logistic regression (OLR) 2.53, 95% CI 1.83 to 3.48;  p  < 0.001]. Women randomised to LASH were also more likely to have the best possible MMAS score of 100 (68.7% vs. 54.5%) (adjusted difference in proportions 0.13, 95% CI 0.04 to 0.23; adjusted OR from OLR 1.87, 95% CI 1.31 to 2.67;  p  = 0.001). Serious adverse event rates were low and similar in both groups (4.5% vs. 3.6%). There was a significant difference in adjusted mean costs between LASH (£2886) and EA (£1282) at 15 months, but no significant difference in QALYs. Based on an extrapolation of expected differences in cost and QALYs out to 10 years, LASH cost an additional £1362 for an average QALY gain of 0.11, equating to an incremental cost-effectiveness ratio of £12,314 per QALY. Probabilities of cost-effectiveness were 53%, 71% and 80% at cost-effectiveness thresholds of £13,000, £20,000 and £30,000 per QALY gained, respectively.
LIMITATIONS


Follow-up data beyond 15 months post randomisation are not available to inform cost-effectiveness.
CONCLUSION


LASH is superior to EA in terms of clinical effectiveness. EA is less costly in the short term, but expected higher retreatment rates mean that LASH could be considered cost-effective by 10 years post procedure.
FUTURE WORK


Retreatment rates, satisfaction and quality-of-life scores at 10-year follow-up will help to inform long-term cost-effectiveness.
TRIAI REGISTRATION


Current Controlled Trials ISRCTN49013893.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 53. See the NIHR Journals Library website for further project information.",2019,"There was a significant difference in adjusted mean costs between LASH (£2886) and EA (£1282) at 15 months, but no significant difference in QALYs.","['heavy menstrual bleeding', 'women with HMB', 'British women', 'Women aged <\u200950 years with HMB', 'Exclusion criteria included plans to conceive; endometrial atypia; abnormal cytology; uterine cavity size >\u200911\u2009cm; any fibroids >\u20093\u2009cm; contraindications to', '330 participants', 'Thirty-one UK secondary and tertiary hospitals']","['laparoscopic surgery; previous EA', 'Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation', 'LASH', 'LASH with second-generation EA']","['possible MMAS score', 'Serious adverse event rates', 'hospital stay', 'incremental cost (NHS perspective) per quality-adjusted life-year (QALY) gained', 'satisfaction and quality-of-life scores', 'patient satisfaction and (2) Menorrhagia Multi-Attribute Quality-of-Life Scale (MMAS) score', 'Probabilities of cost-effectiveness', 'adjusted mean costs', 'clinical effectiveness and cost-effectiveness']","[{'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0227844', 'cui_str': 'Endometrial cavity structure'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0404091', 'cui_str': 'Laparoscopic supracervical hysterectomy (procedure)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0341803', 'cui_str': 'Endometrial Ablation'}]","[{'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0025323', 'cui_str': 'Heavy Menstrual Bleeding'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",330.0,0.26408,"There was a significant difference in adjusted mean costs between LASH (£2886) and EA (£1282) at 15 months, but no significant difference in QALYs.","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Neil W', 'Initials': 'NW', 'LastName': 'Scott', 'Affiliation': 'Medical Statistics Team, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Scotland', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Hernández', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'T Justin', 'Initials': 'TJ', 'LastName': 'Clark', 'Affiliation': ""Birmingham Women's NHS Foundation Trust, Birmingham Women's Hospital, Birmingham, UK.""}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Hawe', 'Affiliation': 'Countess of Chester Hospital NHS Foundation Trust, Chester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawthorn', 'Affiliation': 'NHS Greater Glasgow and Clyde, Southern General Hospital, Glasgow, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Hull and East Yorkshire Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Wileman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'McCormack', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute of Population Health Sciences & Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Siladitya', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23530']
3322,31152308,Effect of corticosteroids on myocardial injury among patients hospitalized for community-acquired pneumonia: rationale and study design. The colosseum trial.,"Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury that can be isolated or associated with myocardial infarction (MI). A retrospective study showed that corticosteroid treatment lowers the incidence of MI during the hospital stay. No data exist so far on the effect of corticosteroids on myocardial injury in CAP patients. The primary objective of the study is to evaluate if methylprednisolone is able to reduce myocardial injury, as assessed by serum high-sensitivity cardiac T Troponin (hs-cTnT), in a cohort of patients hospitalized for CAP. Secondary aims are to evaluate the potential effect of methylprednisolone on cardiovascular events during hospitalization, at 30 days from hospital admission and during 2 years' follow-up. The trial will also examine whether the potential protective effects of methylprednisolone might be due to platelet activation down-regulation. Double-blind randomized placebo-controlled trial. One hundred twenty-two eligible patients will be randomized to a week treatment with iv methylprednisolone (20 mg b.i.d) or placebo from hospital admission. Serum hs-cTnT will be measured at admission and every day until up 3 days from admission. ECG will be monitored every day until discharge. After discharge, all patients will be followed-up 2 years. This is the first clinical trial aimed at examining whether methylprednisolone treatment may reduce myocardial injury. The results of this trial may constitute the basis for conducting a larger multicenter trial aimed to evaluate the effect of corticosteroid on cardiovascular events in this setting.",2020,"Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury that can be isolated or associated with myocardial infarction (MI).","['patients hospitalized for CAP', 'One hundred twenty-two eligible patients', 'CAP patients', 'patients hospitalized for community-acquired pneumonia']","['corticosteroid', 'placebo', 'methylprednisolone', 'corticosteroids']","['cardiovascular events', 'myocardial injury', 'incidence of MI during the hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",122.0,0.547563,"Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury that can be isolated or associated with myocardial infarction (MI).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Violi', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy. francesco.violi@uniroma1.it.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Calvieri', 'Affiliation': 'Department of Cardiovascular, Respiratory, Nephrologic and Geriatric Sciences, La Sapienza University, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cangemi', 'Affiliation': 'Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.'}]",Internal and emergency medicine,['10.1007/s11739-019-02117-0']
3323,30516797,"Efficacy of Prolonged Exposure Therapy, Sertraline Hydrochloride, and Their Combination Among Combat Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial.","Importance


Meta-analyses of treatments for posttraumatic stress disorder (PTSD) suggest that trauma-focused psychotherapies produce greater benefits than antidepressant medications alone.
Objective


To determine the relative efficacy of prolonged exposure therapy plus placebo, prolonged exposure therapy plus sertraline hydrochloride, and sertraline plus enhanced medication management in the treatment of PTSD.
Design, Setting, and Participants


The Prolonged Exposure and Sertraline Trial was a randomized, multisite, 24-week clinical trial conducted at the Veterans Affairs Ann Arbor Healthcare System, Veterans Affairs San Diego Healthcare System, Ralph H. Johnson Veterans Affairs Medical Center, and Massachusetts General Hospital Home Base Veterans Program between January 26, 2012, and May 9, 2016. Participants and clinicians were blinded to pill condition, and outcome evaluators were blinded to assignment. Participants completed assessments at weeks 0 (intake), 6, 12, 24, and 52 (follow-up). Participants (N = 223) were service members or veterans of the Iraq and/or Afghanistan wars with combat-related PTSD and significant impairment (Clinician-Administered PTSD Scale score, ≥50) of at least 3 months' duration. Analyses were on an intent-to-treat basis.
Intervention


Participants completed up to thirteen 90-minute sessions of prolonged exposure therapy by week 24. Sertraline dosage was titrated during a 10-week period and continued until week 24; medication management was manualized.
Main Outcomes and Measures


The primary outcome was symptom severity of PTSD in the past month as assessed by the Clinician-Administered PTSD Scale score at week 24.
Results


Of 223 randomized participants, 149 completed the study at 24 weeks, and 207 (180 men and 27 women; mean [SD] age, 34.5 [8.3 years]) were included in the intent-to-treat analysis. Modified intent-to-treat analysis using a mixed model of repeated measures showed that PTSD symptoms decreased significantly during the 24 weeks (sertraline plus enhanced medication management, 33.8 points; prolonged exposure therapy plus sertraline, 32.7 points; and prolonged exposure therapy plus placebo, 29.4 points; β,-9.39; 95% CI, -11.62 to -7.16; P < .001); however, slopes did not differ by treatment group (prolonged exposure therapy plus placebo group, -9.39; sertraline plus enhanced medication management group, -10.37; and prolonged exposure therapy plus sertraline group, -9.99; P = .81).
Conclusions and Relevance


No difference in change in PTSD symptoms or symptom severity at 24 weeks was found between sertraline plus enhanced medication management, prolonged exposure therapy plus placebo, and prolonged exposure therapy plus sertraline.
Trial Registration


ClinicalTrials.gov Identifier: NCT01524133.",2019,"No difference in change in PTSD symptoms or symptom severity at 24 weeks was found between sertraline plus enhanced medication management, prolonged exposure therapy plus placebo, and prolonged exposure therapy plus sertraline.
","['Veterans Affairs Ann Arbor Healthcare System, Veterans Affairs San Diego Healthcare System, Ralph H. Johnson Veterans Affairs Medical Center, and Massachusetts General Hospital Home Base Veterans Program between January 26, 2012, and May 9, 2016', '149 completed the study at 24 weeks, and 207 (180 men and 27 women; mean [SD] age, 34.5 [8.3 years]) were included in the intent-to-treat analysis', 'posttraumatic stress disorder (PTSD', 'Participants (N\u2009=\u2009223) were service members or veterans of the Iraq', '223 randomized participants', 'Combat Veterans With Posttraumatic Stress Disorder']","['sertraline', 'placebo', 'Sertraline', 'Prolonged Exposure Therapy, Sertraline Hydrochloride, and Their Combination', 'prolonged exposure therapy plus placebo, prolonged exposure therapy plus sertraline hydrochloride, and sertraline']","['symptom severity of PTSD in the past month as assessed by the Clinician-Administered PTSD Scale score', 'PTSD symptoms or symptom severity', 'PTSD symptoms']","[{'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0600526', 'cui_str': 'Sertraline Hydrochloride'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",223.0,0.142922,"No difference in change in PTSD symptoms or symptom severity at 24 weeks was found between sertraline plus enhanced medication management, prolonged exposure therapy plus placebo, and prolonged exposure therapy plus sertraline.
","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Mental Health Service Line, Veterans Affairs Atlanta Healthcare System, Decatur, Georgia.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'Mental Health Service Line, Veterans Affairs Atlanta Healthcare System, Decatur, Georgia.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'Consulting for Statistics, Computing and Analytics Research, University of Michigan, Ann Arbor.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Tuerk', 'Affiliation': 'Mental Health Service Line, Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'Mental Health Service Line, Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Carolyn B', 'Initials': 'CB', 'LastName': 'Allard', 'Affiliation': 'Mental Health Service Line, Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'Mental Health Service Line, Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Venners', 'Affiliation': 'Mental Health Service Line, Veterans Affairs Atlanta Healthcare System, Decatur, Georgia.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'Mental Health Service Line, Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Porter', 'Affiliation': 'Mental Health Service Line, Veterans Affairs Atlanta Healthcare System, Decatur, Georgia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Martis', 'Affiliation': 'Mental Health Service Line, Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'King', 'Affiliation': 'Mental Health Service Line, Veterans Affairs Atlanta Healthcare System, Decatur, Georgia.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'Mental Health Service Line, Veterans Affairs Atlanta Healthcare System, Decatur, Georgia.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Hoge', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2018.3412']
3324,31358408,A randomized open-label trial of 2-dose or 3-dose pre-exposure rabies prophylaxis among Thai children.,"BACKGROUND


World Health Organization changed the recommendation for pre-exposure rabies prophylaxis from 3-dose to 2-dose regimen in 2018. Given limited data of 2-dose regimens in pediatric population, this study aimed to compare the immunogenicity between 2-dose and 3-dose pre-exposure rabies immunization.
METHODS


This study was conducted among healthy children aged 2-12 years. They were randomized to 2-dose vaccination (2D) on days 0 and 28 or 3-dose vaccination (3D) on days 0, 7, and 28. Purified Vero cell rabies vaccine (PVRV-Verorab™) was administered intramuscularly. Rabies virus neutralizing antibody (RVNA) titers were measured at 3 time points: 14-day after complete vaccination, 1-year pre-booster vaccination, and 7-day post-booster dose to mimic scenario of rabies exposure. RVNA titers ≥0.5 IU/ml were considered adequate antibody. T cell specific response to rabies vaccine antigen was measured using the interferon-gamma enzyme linked immunospot assay.
RESULTS


From September to October 2017, 107 participants (51% males), 78 in 2D group and 29 in 3D group were enrolled. Median age was 5.8 years (IQR 4.4-7.3). All participants had RVNA titers ≥0.5 IU/ml after primary vaccination [GMT 2D: 18.6 (95%CI 15.9-21.8) and 3D: 16.3 (95%CI 13.2-20.1 IU/ml), p = 0.35]. At 1-year prior to receiving the booster, only 80% of the children in 2D group maintained RVNA titers ≥0.5 IU/ml compared to 100% of the children in 3D group (p = 0.01). However, all participants in both groups had RVNA ≥0.5 IU/ml at 7-day post booster vaccination [GMT 2D: 20.9 (95%CI 17.4-25.3) and 3D: 22.2 (95%CI 15.8-31.4) IU/ml (P = 0.75)]. The median number of IFN-γ secreting cells at 7-day post-booster dose was 98 and 128 SFCs per 10 6  PBMCs in the 2D and 3D groups, respectively (P = 0.30).
CONCLUSIONS


Two-dose primary rabies immunization provided adequate antibody at post primary vaccination and post booster. The results support 2-dose regimen of pre-exposure rabies immunization in the pediatric population.",2019,"Rabies virus neutralizing antibody (RVNA) titers were measured at 3 time points: 14-day after complete vaccination, 1-year pre-booster vaccination, and 7-day post-booster dose to mimic scenario of rabies exposure.","['From September to October 2017, 107 participants (51% males), 78 in 2D group and 29 in 3D group were enrolled', 'healthy children aged 2-12\u202fyears', 'pediatric population', 'Thai children']","['Purified Vero cell rabies vaccine (PVRV-Verorab™', '2-dose or 3-dose pre-exposure rabies prophylaxis']","['median number of IFN-γ secreting cells', 'RVNA titers']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0042542', 'cui_str': 'Vero Cells'}, {'cui': 'C0034496', 'cui_str': 'Rabies Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1320204', 'cui_str': 'Rabies prophylaxis'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",107.0,0.148799,"Rabies virus neutralizing antibody (RVNA) titers were measured at 3 time points: 14-day after complete vaccination, 1-year pre-booster vaccination, and 7-day post-booster dose to mimic scenario of rabies exposure.","[{'ForeName': 'Pakpoom', 'Initials': 'P', 'LastName': 'Janewongwirot', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Electronic address: Pakpoom.J@chula.ac.th.'}, {'ForeName': 'Watsamon', 'Initials': 'W', 'LastName': 'Jantarabenjakul', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Thai Red Cross Emerging Infectious Diseases Clinical Center (TRC-EID), King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Suvaporn', 'Initials': 'S', 'LastName': 'Anugulruengkitt', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Orawan', 'Initials': 'O', 'LastName': 'Anunsittichai', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Wachiraporn', 'Initials': 'W', 'LastName': 'Saengseesom', 'Affiliation': 'Queen Saovabha Memorial Institute, The Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Supranee', 'Initials': 'S', 'LastName': 'Buranapraditkun', 'Affiliation': 'Cellular Immunology Laboratory, Allergy and Clinical Immunology Unit, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Jiratchaya', 'Initials': 'J', 'LastName': 'Sophonphan', 'Affiliation': 'HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Noppadol', 'Initials': 'N', 'LastName': 'Wacharachaisurapol', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nattapong', 'Initials': 'N', 'LastName': 'Jitrungruengnij', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Chitsanu', 'Initials': 'C', 'LastName': 'Pancharoen', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Thanyawee', 'Initials': 'T', 'LastName': 'Puthanakit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",Vaccine,['10.1016/j.vaccine.2019.07.055']
3325,31383718,Long-term Effects of Moderate versus High Durations of Aerobic Exercise on Biomarkers of Breast Cancer Risk: Follow-up to a Randomized Controlled Trial.,"BACKGROUND


The optimal lifestyle for breast cancer prevention over the long term is unclear. We aimed to determine whether or not the amount of exercise prescribed in a year-long exercise intervention influences breast cancer biomarker levels 1 year later.
METHODS


We conducted a 24-month follow-up study (2012-2014) to the Breast Cancer and Exercise Trial in Alberta (BETA), a 12-month, two-armed (1:1), two-center randomized controlled trial of exercise in 400 cancer-free, postmenopausal women. The exercise prescription was moderate-vigorous aerobic exercise, 5 days/week (3 days/week supervised) for 30 minutes/session (MODERATE) or 60 minutes/session (HIGH). Participants were asked not to change their usual diet. We used linear mixed models to compare biomarker concentrations (C-reactive protein, insulin, glucose, HOMA-IR, estrone, sex hormone binding globulin, total estradiol, and free estradiol) over time (0, 12, and 24 months) by group (MODERATE, HIGH), using group-time interactions.
RESULTS


After 12 months of no intervention, 24-month fasting blood samples were available for 84.0% and 82.5% of MODERATE and HIGH groups, respectively ( n  = 333/400). We found no evidence that 0 to 24- or 12 to 24-month biomarker changes differed significantly between randomized groups (HIGH:MODERATE ratio of mean biomarker change ranged from 0.97 to 1.06,  P  values >0.05 for all). We found more favorable biomarker profiles among participants who experienced greater than the median fat loss during the trial.
CONCLUSIONS


Prescribing aerobic exercise for 300 versus 150 minutes/week for 12 months to inactive, postmenopausal women had no effects on longer-term biomarkers.
IMPACT


Exercise may lead to larger improvements in breast cancer biomarkers after intervention among women who also experience fat loss with exercise.",2019,"Prescribing aerobic exercise for 300 versus 150 minutes/week for 12 months to inactive, postmenopausal women had no effects on longer-term biomarkers.
","['women who also experience fat loss with exercise', '400 cancer-free, postmenopausal women', '24-month follow-up study (2012-2014) to the Breast Cancer and Exercise Trial in Alberta (BETA']","['aerobic exercise', 'Prescribing aerobic exercise', 'exercise', 'exercise prescribed in a year-long exercise intervention']","['biomarker concentrations (C-reactive protein, insulin, glucose, HOMA-IR, estrone, sex hormone binding globulin, total and free estradiol', 'biomarkers of breast cancer risk', '24-month fasting blood samples', 'longer-term biomarkers']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0369189', 'cui_str': 'Free estradiol (substance)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",,0.0629597,"Prescribing aerobic exercise for 300 versus 150 minutes/week for 12 months to inactive, postmenopausal women had no effects on longer-term biomarkers.
","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Friedenreich', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, Cancer Control Alberta, Alberta Health Services, Calgary, Alberta, Canada. christine.friedenreich@albertahealthservices.ca.'}, {'ForeName': 'Qinggang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, Cancer Control Alberta, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Yasui', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Aalo', 'Initials': 'A', 'LastName': 'Duha', 'Affiliation': 'Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Darren R', 'Initials': 'DR', 'LastName': 'Brenner', 'Affiliation': 'Department of Cancer Epidemiology and Prevention Research, Cancer Control Alberta, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Kerry S', 'Initials': 'KS', 'LastName': 'Courneya', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, Alberta, Canada.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-0523']
3326,29893223,Hip arthroscopy versus best conservative care for the treatment of femoroacetabular impingement syndrome (UK FASHIoN): a multicentre randomised controlled trial.,"BACKGROUND


Femoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery, including reshaping the hip, or with physiotherapist-led conservative care. We aimed to compare the clinical effectiveness of hip arthroscopy with best conservative care.
METHODS


UK FASHIoN is a pragmatic, multicentre, assessor-blinded randomised controlled trial, done at 23 National Health Service hospitals in the UK. We enrolled patients with femoroacetabular impingement syndrome who presented at these hospitals. Eligible patients were at least 16 years old, had hip pain with radiographic features of cam or pincer morphology but no osteoarthritis, and were believed to be likely to benefit from hip arthroscopy. Patients with bilateral femoroacetabular impingement syndrome were eligible; only the most symptomatic hip was randomly assigned to treatment and followed-up. Participants were randomly allocated (1:1) to receive hip arthroscopy or personalised hip therapy (an individualised, supervised, and progressive physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre and was done by research staff at each hospital, using a central telephone randomisation service. Patients and treating clinicians were not masked to treatment allocation, but researchers who collected the outcome assessments and analysed the results were masked. The primary outcome was hip-related quality of life, as measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed in all eligible participants who were allocated to treatment (the intention-to-treat population). This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN64081839, and is closed to recruitment.
FINDINGS


Between July 20, 2012, and July 15, 2016, we identified 648 eligible patients and recruited 348 participants: 171 participants were allocated to receive hip arthroscopy and 177 to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% (319 of 348 participants). At 12 months after randomisation, mean iHOT-33 scores had improved from 39·2 (SD 20·9) to 58·8 (27·2) for participants in the hip arthroscopy group, and from 35·6 (18·2) to 49·7 (25·5) in the personalised hip therapy group. In the primary analysis, the mean difference in iHOT-33 scores, adjusted for impingement type, sex, baseline iHOT-33 score, and centre, was 6·8 (95% CI 1·7-12·0) in favour of hip arthroscopy (p=0·0093). This estimate of treatment effect exceeded the minimum clinically important difference (6·1 points). There were 147 patient-reported adverse events (in 100 [72%] of 138 patients) in the hip arthroscopy group) versus 102 events (in 88 [60%] of 146 patients) in the personalised hip therapy group, with muscle soreness being the most common of these (58 [42%] vs 69 [47%]). There were seven serious adverse events reported by participating hospitals. Five (83%) of six serious adverse events in the hip arthroscopy group were related to treatment, and the one in the personalised hip therapy group was not. There were no treatment-related deaths, but one patient in the hip arthroscopy group developed a hip joint infection after surgery.
INTERPRETATION


Hip arthroscopy and personalised hip therapy both improved hip-related quality of life for patients with femoroacetabular impingement syndrome. Hip arthroscopy led to a greater improvement than did personalised hip therapy, and this difference was clinically significant. Further follow-up will reveal whether the clinical benefits of hip arthroscopy are maintained and whether it is cost effective in the long term.
FUNDING


The Health Technology Assessment Programme of the National Institute of Health Research.",2018,"There were no treatment-related deaths, but one patient in the hip arthroscopy group developed a hip joint infection after surgery.
","['enrolled patients with femoroacetabular impingement syndrome who presented at these hospitals', '27·2) for participants in the hip arthroscopy group, and from 35·6 (18·2) to 49·7 (25·5) in the personalised hip therapy group', 'young adults', '23 National Health Service hospitals in the UK', 'patients with femoroacetabular impingement syndrome', 'UK', 'Between July 20, 2012, and July 15, 2016', 'Eligible patients were at least 16 years old, had hip pain with radiographic features of cam or pincer morphology but no osteoarthritis', 'femoroacetabular impingement syndrome (UK FASHIoN', 'Patients with bilateral femoroacetabular impingement syndrome were eligible; only the most symptomatic hip', '648 eligible patients and recruited 348 participants: 171 participants']","['hip arthroscopy and 177 to receive personalised hip therapy', 'hip arthroscopy or personalised hip therapy (an individualised, supervised, and progressive physiotherapist-led programme of conservative care', 'hip arthroscopy with best conservative care', 'Hip arthroscopy versus best conservative care', 'Hip arthroscopy and personalised hip therapy both improved hip']","['mean iHOT-33 scores', 'hip-related quality of life, as measured by the patient-reported International Hip Outcome Tool (iHOT-33', 'adverse events', 'hip joint infection', 'muscle soreness', 'mean difference in iHOT-33 scores, adjusted for impingement type, sex, baseline iHOT-33 score, and centre']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2936290', 'cui_str': 'Femoroacetabular Impingement Syndrome'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4517733', 'cui_str': '348'}]","[{'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019558', 'cui_str': 'Acetabulofemoral Joint'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",171.0,0.174647,"There were no treatment-related deaths, but one patient in the hip arthroscopy group developed a hip joint infection after surgery.
","[{'ForeName': 'Damian R', 'Initials': 'DR', 'LastName': 'Griffin', 'Affiliation': 'University of Warwick, Coventry, UK; University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK. Electronic address: damian.griffin@warwick.ac.uk.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Dickenson', 'Affiliation': 'University of Warwick, Coventry, UK; University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Peter D H', 'Initials': 'PDH', 'LastName': 'Wall', 'Affiliation': 'University of Warwick, Coventry, UK; University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Achana', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Griffin', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hobson', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Hutchinson', 'Affiliation': 'University of Warwick, Coventry, UK; University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Jepson', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Nick R', 'Initials': 'NR', 'LastName': 'Parsons', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'University of Warwick, Coventry, UK.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Realpe', 'Affiliation': 'University of Warwick, Coventry, UK; University of Bristol, Bristol, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'University Hospitals of Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)31202-9']
3327,31451854,The Hemostatic Effect of Desmopressin on Bleeding as a Nasal Spray in Open Septorhinoplasty.,"BACKGROUND


Rhinoplasty is associated with intraoperative bleeding which affects the quality of the operation and may increase the time of surgery. The aim of this study was to assess the role of nasal spray of desmopressin on reduction in intraoperative bleeding during elective open rhinoplasty.
METHODS


Conducting an interventional study in our hospital, all patient data including demographic information, medical history and laboratory tests before surgery were collected. Patients who were randomly divided into two study groups, received nasal desmopressin spray or placebo spray, 60 min before starting open septorhinoplasty. The measured variables included: bleeding volume, the operative field quality in regard to bleeding (Boezaart score), the surgeons' satisfaction in regard to bleeding during surgery (Likert scale), postoperative bruising, postoperative bleeding and menstruation.
RESULTS


Thirty cases were studied; 13 (46.3%) people received placebo and 17 (56.7%) received desmopressin. The Boezaart score, satisfaction scores, bleeding volume, upper eyelid ecchymosis in the group receiving desmopressin were significantly better than the control group. Postoperative bleeding was also less in the desmopressin group, but not significant as other variables. In women of each group, menstruation had no effect on the amount of bleeding, surgical field quality and surgeon satisfaction compared with non-menstruation women.
CONCLUSION


Nasal desmopressin use is an effective method for reducing intraoperative and postoperative bleeding and diminished postoperative ecchymosis which improves surgeons' satisfaction. So using the nasal form of desmopressin could be considered as method of controlling bleeding and ecchymosis in open rhinoplasty.
LEVEL OF EVIDENCE IV


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",2019,Nasal desmopressin use is an effective method for reducing intraoperative and postoperative bleeding and diminished postoperative ecchymosis which improves surgeons' satisfaction.,['Thirty cases were studied; 13 (46.3%) people received'],"['nasal desmopressin spray or placebo spray', 'desmopressin', 'placebo', 'Desmopressin', 'IV', 'Nasal desmopressin']","['intraoperative bleeding', 'Boezaart score, satisfaction scores, bleeding volume, upper eyelid ecchymosis', 'Postoperative bleeding', ""bleeding volume, the operative field quality in regard to bleeding (Boezaart score), the surgeons' satisfaction in regard to bleeding during surgery (Likert scale), postoperative bruising, postoperative bleeding and menstruation"", 'amount of bleeding, surgical field quality and surgeon satisfaction']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure (body structure)'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",,0.0325396,Nasal desmopressin use is an effective method for reducing intraoperative and postoperative bleeding and diminished postoperative ecchymosis which improves surgeons' satisfaction.,"[{'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Haddady-Abianeh', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ahmad Ali', 'Initials': 'AA', 'LastName': 'Rajabpour', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Sanatkarfar', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Farahvash', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ghasemali', 'Initials': 'G', 'LastName': 'Khorasani', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hojjat', 'Initials': 'H', 'LastName': 'Molaei', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran. hmggprs@gmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-019-01485-4']
3328,31381365,Competency-Based Approaches to Community Health: A Randomized Controlled Trial to Reduce Childhood Obesity among Latino Preschool-Aged Children.,"Background:  Health behavior change interventions that target childhood obesity in minority populations have led to inconsistent and short-lived results. The purpose of this study was to test a novel intervention that was personalized and family-based in a Latino population to reduce childhood obesity.  Methods:  Competency-Based Approaches to Community Health (COACH) was a randomized controlled trial. Latino parent - child pairs were recruited from community settings in Nashville, TN. Child eligibility criteria included age 3-5 years and a BMI ≥50th percentile. The intervention included 15 weekly, 90-minute sessions followed by 3 months of twice-monthly health coaching calls. The control group was a twice-monthly school readiness curriculum for 3 months. Sessions were conducted by a health coach in local community centers, with groups of 8-11 parent - child pairs. The primary outcome was child BMI trajectory across 12 months, measured at four times. The intervention's effect was assessed by using a longitudinal, linear mixed-effects growth model, adjusting for child gender, baseline child and parent age, and baseline parent BMI and education.  Results:  Of the 305 parent - child pairs assessed for eligibility, 117 were randomized (59 intervention, 58 control). Child BMI was available for 91.5% at 1-year follow-up. Mean baseline child age was 4.2 [standard deviation (SD) = 0.8] years, and 53.8% of children were female. Mean baseline child BMI was 18.1 (SD = 2.6) kg/m 2 . After adjusting for covariates, the intervention's effect on linear child BMI growth was -0.41 kg/m 2  per year (95% confidence interval -0.82 to 0.01;  p  = 0.05).  Conclusions:  Over 1-year follow-up, the intervention resulted in slower linear BMI growth for Latino preschool-aged children from poverty.",2019,"After adjusting for covariates, the intervention's effect on linear child BMI growth was -0.41 kg/m 2  per year (95% confidence interval -0.82 to 0.01;  p  = 0.05).  ","['305 parent - child pairs assessed for eligibility, 117 were randomized (59 intervention, 58 control', 'Latino parent - child pairs were recruited from community settings in Nashville, TN', 'Latino Preschool-Aged Children', 'Latino preschool-aged children from poverty', 'Child eligibility criteria included age 3-5 years and a BMI ≥50th percentile', 'Community Health', 'Mean baseline child age was 4.2 [standard deviation (SD)\u2009=\u20090.8] years, and 53.8% of children were female']",['Methods:  Competency-Based Approaches to Community Health (COACH'],"['child BMI trajectory', 'slower linear BMI growth', 'Child BMI', 'Childhood Obesity', 'linear child BMI growth', 'Mean baseline child BMI']","[{'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",117.0,0.0917583,"After adjusting for covariates, the intervention's effect on linear child BMI growth was -0.41 kg/m 2  per year (95% confidence interval -0.82 to 0.01;  p  = 0.05).  ","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Heerman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Teeters', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Sommer', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Burgess', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Escarfuller', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Van Wyk', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Duhon', 'Affiliation': 'School of Medicine, Louisiana State University Health Sciences Center New Orleans, New Orleans, LA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, SUNY at Buffalo, Buffalo, NY.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Samuels', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Marcy', 'Initials': 'M', 'LastName': 'Singer-Gabella', 'Affiliation': 'Department of Teaching and Learning, Vanderbilt University, Nashville, TN.'}]",Childhood obesity (Print),['10.1089/chi.2019.0064']
3329,31399275,"Immunogenicity and safety of an inactivated enterovirus A71 vaccine in children 3-6 years and 2-35 months of age- an open-label, randomized phase IIb clinical trial.","BACKGROUND


Enterovirus A71 (EV-A71) infection can cause severe debilitating complications and even death in young children. The immunogenicity and safety of an inactivated whole EV-A71 virus vaccine were assessed in children 2 months to 6 years of age.
METHODS


This was an open-label, multi-center and randomized phase IIb study, which divided into part A and B. In part A, children 36 months to 6 years of age were enrolled and randomized into 3 groups, receiving 0.5 μg total viral protein (TP) with adjuvant Al(OH)3, 1.0 μg TP with Al(OH)3 or 1.0 μg TP only. Two doses of vaccines were administered at a 28-day interval and blood was taken before immunization, at week 4, 8, 28 and 52 (optional) for virus neutralization assay. Safety profiles were also monitored. After safety profiles had shown no concerns, children 2 months to 35 months of age (part B) were subsequently enrolled following the same protocol.
RESULTS


A total of 135 children completed two doses of immunization, including 58 in part A and 77 in part B. Both adjuvanted 0.5 μg and 1.0 μg TP elicited significant raise of neutralizing antibody titers and seroconversion rate was up to 93.75-100.0% after 2 doses of immunization. Adjuvanted 1.0 μg TP induced higher titers of neutralizing antibodies than adjuvanted 0.5 μg TP. By contrast, non-adjuvanted 1.0 μg TP was not immunogenic. No major adverse events were reported.
CONCLUSIONS


This EV-A71 vaccine containing adjuvant is immunogenic and safe in children 2 months to 6 years of age.
CLINICAL TRIALS REGISTRATION


NCT03268083.",2019,Adjuvanted 1.0 μg TP induced higher titers of neutralizing antibodies than adjuvanted 0.5 μg TP.,"['135 children completed two doses of immunization, including 58 in part A and 77 in part', 'young children', 'children 2\u202fmonths to 6\u202fyears of age', 'children 36\u202fmonths to 6\u202fyears of age', 'children 3-6\u202fyears and 2-35\u202fmonths of age- an open-label, randomized phase IIb clinical trial']","['inactivated whole EV-A71 virus vaccine', 'inactivated enterovirus A71 vaccine', 'receiving 0.5\u202fμg total viral protein (TP) with adjuvant Al(OH)3, 1.0\u202fμg TP with Al(OH)3 or 1.0\u202fμg TP only']","['Immunogenicity and safety', 'neutralizing antibody titers and seroconversion rate', 'immunogenicity and safety', 'higher titers of neutralizing antibodies']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0014383', 'cui_str': 'Enterovirus'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042736', 'cui_str': 'Viral Gene Products'}, {'cui': 'C0077287', 'cui_str': 'tris(acetylacetonate) aluminum(III)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",135.0,0.0535504,Adjuvanted 1.0 μg TP induced higher titers of neutralizing antibodies than adjuvanted 0.5 μg TP.,"[{'ForeName': 'Miao-Chiu', 'Initials': 'MC', 'LastName': 'Hung', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan, ROC. Electronic address: mchung@vghtpe.gov.tw.'}, {'ForeName': 'Ching-Yi', 'Initials': 'CY', 'LastName': 'Cho', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Chen', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Chou-Cheng', 'Initials': 'CC', 'LastName': 'Lai', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan, ROC.'}, {'ForeName': 'Keh-Gong', 'Initials': 'KG', 'LastName': 'Wu', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan, ROC. Electronic address: kgwu@vghtpe.gov.tw.'}]",Vaccine,['10.1016/j.vaccine.2019.07.096']
3330,31512101,A Prospective Randomized Trial Comparing Jejunostomy and Nasogastric Feeding in Minimally Invasive McKeown Esophagectomy.,"BACKGROUND


Early postoperative enteral nutrition is recommended for patients undergoing esophagectomy; however, the optimum method of tube feeding remains controversial. Thus, the aim of this study is to assess two common enteral nutrition methods after minimally invasive McKeown esophagectomy.
METHODS


A randomized controlled trial was performed with 120 patients who underwent minimally invasive McKeown esophagectomy from January 2017 to December 2018. The patients were randomly divided so that 58 patients were in the jejunostomy feeding (JF) group and 62 patients were in the nasogastric feeding (NF) group. The postoperative outcomes, including complications, nutritional status, quality of life, and survival rate, were studied and used as the main parameters to compare the abovementioned tube feeding methods.
RESULTS


The incidence of overall complications was equivalent between the two groups (P = 0.625), except for bowel obstruction (which occurred 4 times in the JF group but did not occur in the NF group). In the first month after surgery (postoperative month 1, POM1), a significantly higher body mass index (BMI) was observed in the JF group (23.6 ± 3.2) than in the NF group (20.9 ± 3.5, P = 0.032). The global quality-of-life scores were better in the JF group than in the NF group (P < 0.001). In addition, there were no significant differences between the two groups in terms of disease-free survival (DFS) (P = 0.816) and overall survival (OS) (P = 0.564).
CONCLUSIONS


Compared with NF, JF provides more safety, efficacy, and utility as nutritional support for minimally invasive McKeown esophagectomy patients who have a high incidence of anastomotic leakage. However, the higher risk of intestinal obstruction after JF requires attention.",2020,"The incidence of overall complications was equivalent between the two groups (P = 0.625), except for bowel obstruction (which occurred 4 times in the JF group but did not occur in the NF group).","['120 patients who underwent', 'minimally invasive McKeown esophagectomy patients who have a high incidence of anastomotic leakage', 'from January 2017 to December 2018', 'Minimally Invasive McKeown Esophagectomy', 'patients undergoing esophagectomy']","['nasogastric feeding (NF', 'jejunostomy feeding (JF', 'NF, JF', 'Jejunostomy and Nasogastric Feeding', 'minimally invasive McKeown esophagectomy']","['disease-free survival (DFS', 'incidence of overall complications', 'postoperative outcomes, including complications, nutritional status, quality of life, and survival rate', 'overall survival (OS', 'body mass index (BMI', 'global quality-of-life scores', 'bowel obstruction']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0472888', 'cui_str': 'McKeown esophagectomy (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0192715', 'cui_str': 'Jejunostomy feeding (regime/therapy)'}, {'cui': 'C0022377', 'cui_str': 'Jejunostomy'}, {'cui': 'C0192456', 'cui_str': 'Nasogastric tube feeding'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0472888', 'cui_str': 'McKeown esophagectomy (procedure)'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0034380'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}]",,0.0333319,"The incidence of overall complications was equivalent between the two groups (P = 0.625), except for bowel obstruction (which occurred 4 times in the JF group but did not occur in the NF group).","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Tao', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Shaojin', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Zhengzheng', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'You', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, China. dongxusuda@126.com.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04390-y']
3331,31377711,Process evaluation of team-based care in people aged >65 years with type 2 diabetes mellitus.,"OBJECTIVE


The prevalence of type 2 diabetes mellitus (T2DM) is increasing globally and there is critical need develop interventions to improve health outcomes among older people. The Group Appointments in Primary Care (GAP) study was a randomised controlled trial designed to test the efficacy of a group and team-based medical visit programme to lower haemoglobin A1c among patients with T2DM. We aimed to understand the barriers and facilitators to implement the GAP intervention within a primary care setting, with an emphasis on patient experience.
RESEARCH DESIGN AND METHODS


This was a qualitative exploratory study. Data were gathered from semistructured interviews conducted with the first cohort of GAP study participants (n=15) at baseline and intervention completion. GAP participants were aged >65, diagnosed with T2DM and from one primary care clinic. The interview questions identified the patient perspectives and factors relating to their attendance at seven group medical visits that were part of the intervention programme. Data were analysed using framework analysis.
RESULTS


We identified four themes that captured participants' experiences: (1) Education: learning with professionals, learning with one another; (2) Social Support: common interests, common problems; (3) Setting: ease of location, ease of conversation and (4) Impact: expectations met, empowerment gained. The GAP intervention increased participants' self-reported diabetes literacy and self-management skills.
CONCLUSIONS


We learnt that: accessible community centres, not primary care offices, were the ideal location for GAP; the consistent leadership of the primary care physician was valued by participants; and, the content related to exercise and healthy diet were viewed as impactful. Also, learning was achieved through content delivered by clinical experts, and by T2DM experts with lived experience-the GAP peers. Our findings highlight the important role of group learning.
TRIAL REGISTRATION NUMBER


NCT02002143.",2019,The Group Appointments in Primary Care (GAP) study was a randomised controlled trial designed to test the efficacy of a group and team-based medical visit programme to lower haemoglobin A1c among patients with T2DM.,"['GAP participants were aged >65, diagnosed with T2DM and from one primary care clinic', 'people aged >65 years with type 2 diabetes mellitus', 'older people']","['GAP intervention', 'team-based medical visit programme to lower haemoglobin A1c among patients with T2DM', 'Education: learning with professionals, learning with one another; (2) Social Support: common interests, common problems; (3) Setting: ease of location, ease of conversation and (4) Impact: expectations met, empowerment gained']","[""participants' self-reported diabetes literacy and self-management skills""]","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0037438'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]",,0.0401756,The Group Appointments in Primary Care (GAP) study was a randomised controlled trial designed to test the efficacy of a group and team-based medical visit programme to lower haemoglobin A1c among patients with T2DM.,"[{'ForeName': 'Joanie', 'Initials': 'J', 'LastName': 'Sims Gould', 'Affiliation': 'Centre for Hip Health and Mobility, University of British Columbia, Vancouver, British Columbia, Canada simsg@mail.ubc.ca.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Tong', 'Affiliation': 'Centre for Hip Health and Mobility, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ly', 'Affiliation': 'Centre for Hip Health and Mobility, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vazirian', 'Affiliation': 'Centre for Hip Health and Mobility, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Adriaan', 'Initials': 'A', 'LastName': 'Windt', 'Affiliation': 'Centre for Hip Health and Mobility, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Khan', 'Affiliation': 'Centre for Hip Health and Mobility, University of British Columbia, Vancouver, British Columbia, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-029965']
3332,30484743,Feasibility and Acceptability of an Electronic Parenting Skills Intervention for Parents of Alcohol-Using Adolescent Trauma Patients.,"Background:  Identifying problem drinkers and providing brief intervention (BI) for those who screen positive are required within all level I trauma centers. While parent-adolescent relationships impact adolescent alcohol use, parenting skills are rarely included in adolescent alcohol BIs within pediatric trauma centers.   Introduction:  The primary objective of this study was to examine the feasibility and acceptability of an electronic parenting skills intervention for parents of injured adolescents who report alcohol or drug use.   Materials and Methods:  Across three pediatric level I trauma centers, admitted trauma patients 12-17 years of age, screening positive for alcohol or drug use, were consented along with one parent. Adolescent-parent dyads were enrolled and assigned to the intervention (Parenting Wisely web-based modules coupled with text messaging) or standard care conditions using a 2:1 allocation ratio. Teens completed 3- and 6-month follow-up surveys; parents completed 3-month follow-up surveys.   Results:  Thirty-seven dyads were enrolled into the study. Only one-third of parents accessed the web-based Parenting Wisely after baseline. All parents completed the text message program. At 3-month follow-up, 78% of parents endorsed that they would recommend the program to others. There were no significant differences in adolescent substance use or parenting behaviors between groups at follow-up.   Discussion:  A texting component is well received, but web-based components may be underutilized. Larger studies are necessary to determine if an electronic skills intervention has an effect on parenting skills and adolescent substance use.   Conclusions:  This study demonstrated accessibility and feasibility of an e-parenting intervention with more utilization of text components than web-based.",2019,"There were no significant differences in adolescent substance use or parenting behaviors between groups at follow-up.
","['Parents of Alcohol-Using Adolescent Trauma Patients', 'Thirty-seven dyads were enrolled into the study', 'parents of injured adolescents who report alcohol or drug use', 'Adolescent-parent dyads', 'Across three pediatric level I trauma centers, admitted trauma patients 12-17 years of age, screening positive for alcohol or drug use, were consented along with one parent']","['intervention (Parenting Wisely web-based modules coupled with text messaging) or standard care conditions using a 2:1 allocation ratio', 'e-parenting intervention', 'electronic parenting skills intervention', 'Electronic Parenting Skills Intervention']","['adolescent substance use or parenting behaviors', 'Feasibility and Acceptability', 'feasibility and acceptability']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",37.0,0.0579573,"There were no significant differences in adolescent substance use or parenting behaviors between groups at follow-up.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mello', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Bromberg', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Baird', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Hale', 'Initials': 'H', 'LastName': 'Wills', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Gaines', 'Affiliation': ""Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Lapidus', 'Affiliation': ""Connecticut Children's Medical Center, Hartford, Connecticut.""}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Ranney', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Parnagian', 'Affiliation': 'Injury Prevention Center, Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0201']
3333,31021124,The role of patient beliefs in open-label placebo effects.,"OBJECTIVE


Recent research on open-label placebos, or placebos administered without deception or concealment, suggests that they can be effective in a variety of conditions. The current research sought to unpack the mechanisms underlying the treatment efficacy of open-label placebos.
METHOD


A health care provider induced an allergic reaction in 148 participants via a histamine skin prick test. Participants were then exposed to 1 of 4 conditions additively leveraging various mechanisms of open-label placebo treatments: a supportive patient-provider relationship, a medical ritual, positive expectations, and a rationale about the power of placebos.
RESULTS


There were no main effects of condition on allergic responses. However, participant beliefs about placebos moderated the effect of open-label placebo treatment condition on physiological allergic reactions: the condition including all 4 components of open-label placebos (a supportive patient-provider relationship, a medical ritual, positive expectations, and a rationale about the power of placebos) significantly reduced physiological allergic reaction among participants with a strong belief in placebos compared with participants in the control group.
CONCLUSION


Participants' beliefs about placebos interact with information from the provider to reduce physiological allergic reactions in response to an open-label placebo treatment. This study underscores the importance of measuring and understanding how participants' beliefs influence outcomes of treatment, and furthers our understanding of when and how open-label placebo treatments work. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,There were no main effects of condition on allergic responses.,"['participants with a strong belief in placebos compared with participants in the control group', '148 participants via a histamine skin prick test']",['placebos'],"['physiological allergic reaction', 'physiological allergic reactions', 'allergic responses']","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}]",,0.0508888,There were no main effects of condition on allergic responses.,"[{'ForeName': 'Kari A', 'Initials': 'KA', 'LastName': 'Leibowitz', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Emerson J', 'Initials': 'EJ', 'LastName': 'Hardebeck', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'J Parker', 'Initials': 'JP', 'LastName': 'Goyer', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Alia J', 'Initials': 'AJ', 'LastName': 'Crum', 'Affiliation': 'Department of Psychology.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000751']
3334,31711422,Hypoxia preconditioning attenuates lung injury after thoracoscopic lobectomy in patients with lung cancer: a prospective randomized controlled trial.,"BACKGROUND


Hypoxic preconditioning (HPC) may protect multiple organs from various injuries. We hypothesized that HPC would reduce lung injury in patients undergoing thoracoscopic lobectomy.
METHODS


In a prospective randomized controlled trial, 70 patients undergoing elective thoracoscopic lobectomy were randomly allocated to the HPC group or the control group. Three cycles of 5-min hypoxia and 3-min ventilation applied to the nondependent lung served as the HPC intervention. The primary outcome was the PaO 2 /FiO 2  ratio. Secondary outcomes included postoperative pulmonary complications, pulmonary function, and duration of hospital stay.
RESULTS


HPC significantly increased the PaO 2 /FiO 2  ratio compared with the control at 30 min after one-lung ventilation and 7 days after operation. Compared with the control, it also significantly improved postoperative pulmonary function and markedly reduced the postoperative hospital stay duration. No significant differences between groups were observed in the incidence of pulmonary complications or overall postoperative morbidity.
CONCLUSIONS


HPC improves postoperative oxygenation, enhances the recovery of pulmonary function, and reduces the duration of hospital stay in patients undergoing thoracoscopic lobectomy.
TRIAL REGISTRATION


This study was registered in the Chinese Clinical Trial Registry (ChiCTR-IPR-17011249) on April 27, 2017.",2019,"No significant differences between groups were observed in the incidence of pulmonary complications or overall postoperative morbidity.
","['patients with lung cancer', 'patients undergoing thoracoscopic lobectomy', '70 patients undergoing']","['thoracoscopic lobectomy', 'Hypoxia preconditioning', 'HPC', 'Hypoxic preconditioning (HPC', 'elective thoracoscopic lobectomy']","['lung injury', 'duration of hospital stay', 'postoperative pulmonary function', 'postoperative oxygenation', 'incidence of pulmonary complications or overall postoperative morbidity', 'recovery of pulmonary function', 'PaO 2 /FiO 2  ratio', 'postoperative hospital stay duration', 'postoperative pulmonary complications, pulmonary function, and duration of hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}]","[{'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0768635', 'cui_str': 'HPC(III)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0273115', 'cui_str': 'Pulmonary Injury'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",70.0,0.112158,"No significant differences between groups were observed in the incidence of pulmonary complications or overall postoperative morbidity.
","[{'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Zhoushan Hospital, No.739 Dingshen Street, Zhoushan, Zhejiang, China.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Suzhou Municipal Hospital (North District), Nanjing Medical University Affiliated Suzhou Hospital, No.242 Guangji Road, Suzhou, Jiangsu, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Zhoushan Hospital, No.739 Dingshen Street, Zhoushan, Zhejiang, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Zhoushan Hospital, No.739 Dingshen Street, Zhoushan, Zhejiang, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Zhoushan Hospital, No.739 Dingshen Street, Zhoushan, Zhejiang, China.'}, {'ForeName': 'Feixiang', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, No.225 Changhai Road, Shanghai, China. feixiangwu@hotmail.com.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Zhoushan Hospital, No.739 Dingshen Street, Zhoushan, Zhejiang, China. zy476291@163.com.'}]",BMC anesthesiology,['10.1186/s12871-019-0854-z']
3335,31577177,Increasing Vegetable Intake by Emphasizing Tasty and Enjoyable Attributes: A Randomized Controlled Multisite Intervention for Taste-Focused Labeling.,"Healthy food labels tout health benefits, yet most people prioritize tastiness in the moment of food choice. In a preregistered intervention, we tested whether taste-focused labels compared with health-focused labels increased vegetable intake at five university dining halls throughout the United States. Across 137,842 diner decisions, 185 days, and 24 vegetable types, taste-focused labels increased vegetable selection by 29% compared with health-focused labels and by 14% compared with basic labels. Vegetable consumption also increased. Supplementary studies further probed the mediators, moderators, and boundaries of these effects. Increased expectations of a positive taste experience mediated the effect of taste-focused labels on vegetable selection. Moderation tests revealed greater effects in settings that served tastier vegetable recipes. Taste-focused labels outperformed labels that merely contained positive words, fancy words, or lists of ingredients. Together, these studies show that emphasizing tasty and enjoyable attributes increases vegetable intake in real-world settings in which vegetables compete with less healthy options.",2019,"Across 137,842 diner decisions, 185 days, and 24 vegetable types, taste-focused labels increased vegetable selection by 29% compared with health-focused labels and by 14% compared with basic labels.",[],['taste-focused labels compared with health-focused labels increased vegetable intake'],"['Increasing Vegetable Intake by Emphasizing Tasty and Enjoyable Attributes', 'Vegetable consumption', 'vegetable selection']",[],"[{'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.229194,"Across 137,842 diner decisions, 185 days, and 24 vegetable types, taste-focused labels increased vegetable selection by 29% compared with health-focused labels and by 14% compared with basic labels.","[{'ForeName': 'Bradley P', 'Initials': 'BP', 'LastName': 'Turnwald', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Jaclyn D', 'Initials': 'JD', 'LastName': 'Bertoldo', 'Affiliation': 'Residential and Dining Enterprises, Stanford University.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Perry', 'Affiliation': 'Department of Psychology, Stanford University.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Policastro', 'Affiliation': 'Institute for Food, Nutrition, and Health, Rutgers University.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Timmons', 'Affiliation': 'Dining Services, Northeastern University.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bosso', 'Affiliation': 'School of Public Policy and Urban Affairs, Northeastern University.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Connors', 'Affiliation': 'Department of Hospitality and Tourism Management, University of North Texas.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Valgenti', 'Affiliation': 'Department of Philosophy, Lebanon Valley College.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Pine', 'Affiliation': 'USC Hospitality, University of Southern California.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Challamel', 'Affiliation': 'Menus of Change University Research Collaborative.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Stanford University.'}, {'ForeName': 'Alia J', 'Initials': 'AJ', 'LastName': 'Crum', 'Affiliation': 'Department of Psychology, Stanford University.'}]",Psychological science,['10.1177/0956797619872191']
3336,31691018,Acute p-synephrine ingestion increases whole-body fat oxidation during 1-h of cycling at Fatmax.,"PURPOSE


p-Synephrine, the principal alkaloid of bitter orange (Citrus aurantium), is widely used in dietary supplements for weight loss due to its purported effect of increasing fat oxidation. However, there is a paucity of scientific information about its effectiveness in enhancing fat oxidation during exercise. The aim of this investigation was to determine the effect of an acute dose of p-synephrine on substrate oxidation during prolonged and constant intensity exercise.
METHODS


In a double-blind and randomized experiment, 14 healthy subjects performed two acute experimental trials after ingesting either p-synephrine (3 mg kg -1 ) or a placebo (cellulose). Energy expenditure and fat oxidation rates were continuously measured by indirect calorimetry during 1 h of continuous cycling at Fatmax, the intensity that induces maximal fat oxidation rate.
RESULTS


In comparison to the placebo, energy expenditure during 1 h of cycling remained unchanged with p-synephrine (698 ± 129 vs. 686 ± 123 kcal, P = 0.08). However, p-synephrine increased whole-body fat oxidation (33.6 ± 10.4 vs. 37.3 ± 9.8 g, P < 0.01) while also reducing carbohydrate oxidation (99.5 ± 30.4 vs. 85.0 ± 28.4 g, P < 0.01). However, the magnitude of the shift on substrate oxidation induced by p-synephrine was small.
CONCLUSION


Acute ingestion of p-synephrine augments fat oxidation during prolonged and constant-intensity exercise.",2020,"In comparison to the placebo, energy expenditure during 1 h of cycling remained unchanged with p-synephrine (698 ± 129 vs. 686 ± 123 kcal, P = 0.08).",['14 healthy subjects performed two acute experimental trials after ingesting either'],"['placebo', 'p-synephrine', 'placebo (cellulose']","['body fat oxidation', 'energy expenditure', 'substrate oxidation', 'p-synephrine increased whole-body fat oxidation', 'carbohydrate oxidation', 'Energy expenditure and fat oxidation rates']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039086', 'cui_str': 'Synephrine'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0039086', 'cui_str': 'Synephrine'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",14.0,0.181183,"In comparison to the placebo, energy expenditure during 1 h of cycling remained unchanged with p-synephrine (698 ± 129 vs. 686 ± 123 kcal, P = 0.08).","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruiz-Moreno', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Universidad Rey Juan Carlos, Fuenlabrada, Spain. juan.delcoso@urjc.es.'}]",European journal of nutrition,['10.1007/s00394-019-02101-6']
3337,31761416,Ultrasound-guided bilateral superficial cervical plexus blocks enhance the quality of recovery in patients undergoing thyroid cancer surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Regional anesthesia can improve postoperative analgesia and enhance the quality of recovery (QoR) after surgery. This trial evaluates the effects of ultrasound-guided bilateral superficial cervical plexus block (SCPB) on QoR in patients undergoing thyroid cancer surgery.
DESIGN


Prospective, randomized, double-blinded, placebo-controlled trial.
SETTING


Operating room.
PATIENTS


Seventy-four ASA I-II female patients scheduled for thyroid cancer surgery were included to the study.
INTERVENTIONS


Patients were randomly allocated to receive pre-operative ultrasound-guided bilateral SCPB with 10 ml of ropivacaine 0.5% or normal saline on each side.
MEASUREMENTS


The primary endpoint was the quality of recovery, which was assessed using the 15-item quality of recovery questionnaire (QoR-15). Secondary endpoints were acute postoperative pain, time to first rescue analgesia, the number of patients requiring rescue analgesia, length of post-anesthesia care unit (PACU) stay, the incidence of postoperative nausea or vomiting (PONV) and dizziness, and patient satisfaction.
MAIN RESULTS


The global QoR-15 score at 24 h postoperatively was significantly higher in the SCPB group (Median [IQR], 118 [115-120]) than the control group (110 [106-112]) with a median difference of 8 (95% CI: 6 to 10, P < .001). Compared with the control group, pre-operative ultrasound-guided bilateral SCPB reduced postoperative pain up to 24 h and the incidence of PONV, as well as the length of PACU stay. Additionally, the patient satisfaction scores were improved in the SCPB group (P = .024).
CONCLUSION


Pre-operative ultrasound-guided bilateral SCPB with ropivacaine enhances the quality of recovery, postoperative analgesia and patient satisfaction, alleviates the incidence of PONV, and accelerates the PACU discharge following thyroid cancer surgery.",2020,"Compared with the control group, pre-operative ultrasound-guided bilateral SCPB reduced postoperative pain up to 24 h and the incidence of PONV, as well as the length of PACU stay.","['Seventy-four ASA I-II female patients scheduled for thyroid cancer surgery were included to the study', 'patients undergoing thyroid cancer surgery']","['pre-operative ultrasound-guided bilateral SCPB with 10\u202fml of ropivacaine 0.5% or normal saline on each side', 'ropivacaine', 'placebo', 'SCPB', 'Ultrasound-guided bilateral superficial cervical plexus blocks', 'ultrasound-guided bilateral superficial cervical plexus block (SCPB']","['15-item quality of recovery questionnaire (QoR-15', 'postoperative pain', 'patient satisfaction scores', 'quality of recovery', 'acute postoperative pain, time to first rescue analgesia, the number of patients requiring rescue analgesia, length of post-anesthesia care unit (PACU) stay, the incidence of postoperative nausea or vomiting (PONV) and dizziness, and patient satisfaction', 'quality of recovery (QoR', 'global QoR-15 score', 'quality of recovery, postoperative analgesia and patient satisfaction, alleviates the incidence of PONV, and accelerates the PACU discharge']","[{'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0441598', 'cui_str': 'Operative ultrasound (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0074684', 'cui_str': 'small cardioactive peptide B'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0394691', 'cui_str': 'Superficial cervical plexus block (procedure)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",74.0,0.489894,"Compared with the control group, pre-operative ultrasound-guided bilateral SCPB reduced postoperative pain up to 24 h and the incidence of PONV, as well as the length of PACU stay.","[{'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College, Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Cailing', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Oncological Surgery, Fujian Provincial Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Qiaolan', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College, Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Hongxin', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College, Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Lufen', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College, Fujian Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, Shengli Clinical Medical College, Fujian Medical University, Fuzhou, Fujian, China; Department of Anesthesiology, Fujian Provincial Hospital & Fujian Provincial Emergency Center, Fuzhou, Fujian, China. Electronic address: fjslmzk@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2019.109651']
3338,31253071,Individual- and Ad-Level Predictors of Perceptions of Serious and Actionable Risks in Direct-to-Consumer Prescription Drug TV Advertising.,"Prescription drug broadcast advertisements in the United States are required to present the product's major risks in at least the audio portion of the ad (21 CFR 202.1(e)(1)). This can result in a lengthy list of risks and side effects. The U.S. Food and Drug Administration has been studying the effects of limiting the major statement to those risks that are serious and actionable. We explore the level of agreement between consumers and experts regarding what risks and side effects are serious and actionable, and how variations in the content of major risk statement as well as other factors such as demographic variables, perceived accuracy of direct-to-consumer advertising, illness knowledge, and knowledge of prescription drug regulations, predict perceptions of risk and actionability. Participants (N = 1,000) self-diagnosed with depression or insomnia were randomly assigned to view a television ad for their respective condition that presented the full major statement or an edited version that included only serious and actionable risks. Results indicated consumers' perceptions of risk severity generally matched experts' assessment, but there was relatively less agreement about risk actionability. Results also varied as a function of income and gender.",2019,"Results indicated consumers' perceptions of risk severity generally matched experts' assessment, but there was relatively less agreement about risk actionability.","['Participants (N\xa0', '1,000) self-diagnosed with depression or insomnia']",['view a television ad for their respective condition that presented the full major statement or an edited version that included only serious and actionable risks'],[],"[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1720467', 'cui_str': 'Only'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",[],,0.0168382,"Results indicated consumers' perceptions of risk severity generally matched experts' assessment, but there was relatively less agreement about risk actionability.","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': 'a US Food and Drug Administration, Office of Prescription Drug Promotion , Silver Spring , Maryland , USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Boudewyns', 'Affiliation': 'b Science in the Public Sphere, Center for Communication Science, RTI International , Research Triangle Park , North Carolina , USA.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Betts', 'Affiliation': 'a US Food and Drug Administration, Office of Prescription Drug Promotion , Silver Spring , Maryland , USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Southwell', 'Affiliation': 'b Science in the Public Sphere, Center for Communication Science, RTI International , Research Triangle Park , North Carolina , USA.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'b Science in the Public Sphere, Center for Communication Science, RTI International , Research Triangle Park , North Carolina , USA.'}]",Journal of health communication,['10.1080/10810730.2019.1632396']
3339,31765871,Effect of creativity training on teaching for creativity for nursing faculty in Taiwan: A quasi-experimental study.,"BACKGROUND


Creativity and innovation are considered important core competencies in Taiwan for nursing students. Teachers play a critical role in the development of student creativity. Although studies have investigated creativity training, there is no consensus on how best to evaluate the effectiveness of the training.
OBJECTIVE


To evaluate whether a teaching for creativity module (TCM) can enhance teaching behaviors and self-efficacy of teaching creativity for capstone course nursing faculty. The TCM intervention was taught in two stages by experts in diverse areas of industrial design. A 2-day teaching creativity workshop was followed by reinforcement of creativity skills in the classroom with nursing and design faculties teaching side-by-side for 6 h of the 18-week capstone course.
DESIGN


This quasi-experimental study employed a pretest-posttest design to compare an intervention and control group.
PARTICIPANTS AND SETTING


Capstone course nursing faculties were recruited from five science and technology universities in Taiwan.
RESULTS


Forty-two capstone faculty members participated; 21 completed the TCM intervention and 21 were in the control group. Analysis of covariance (ANCOVA) demonstrated the TCM intervention group had significantly better post-test mean scores for creative teaching behaviors and self-efficacy of teaching creativity than the control group. Our findings suggest participation in a creativity workshop and reinforcement of teaching skills with classroom interdisciplinary teacher training can augment teaching for creativity of nursing faculty.
CONCLUSION


The findings of this study indicate that an intervention program in creativity can increase teaching behaviors as well as perceptions of self-efficacy regarding teaching for creativity, which could foster student creativity. These findings have important implications for educational settings, as they suggest that the workshop and reinforcement of learning with hands-on guidance in creativity with interdisciplinary teaching should be integrated into the curriculum, which could facilitate student creativity by increasing teaching behaviors and improving self-confidence regarding teaching creativity.",2020,Analysis of covariance (ANCOVA) demonstrated the TCM intervention group had significantly better post-test mean scores for creative teaching behaviors and self-efficacy of teaching creativity than the control group.,"['Capstone course nursing faculties were recruited from five science and technology universities in Taiwan', 'Forty-two capstone faculty members participated; 21 completed the', 'nursing faculty in Taiwan', 'Taiwan for nursing students']","['teaching for creativity module (TCM', 'creativity training', 'TCM intervention', 'classroom interdisciplinary teacher training']",['creative teaching behaviors and self-efficacy of teaching creativity'],"[{'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0015538', 'cui_str': 'Faculty, Nursing'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]","[{'cui': 'C0010297', 'cui_str': 'Creative Thinking'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4082803', 'cui_str': 'Teacher Training'}]","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0010297', 'cui_str': 'Creative Thinking'}]",21.0,0.016704,Analysis of covariance (ANCOVA) demonstrated the TCM intervention group had significantly better post-test mean scores for creative teaching behaviors and self-efficacy of teaching creativity than the control group.,"[{'ForeName': 'Hsing-Yuan', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, No. 261, Wunhua 1st Rd., Gueishan Township, Taoyuan 33303, Taiwan, ROC; Chang Gung Memorial Hospital, No.5, Fuxing St., Guishan Dist., Taoyuan City 333, Taiwan, ROC. Electronic address: hyliu@mail.cgust.edu.tw.'}, {'ForeName': 'I-Teng', 'Initials': 'IT', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, No. 261, Wunhua 1st Rd., Gueishan Township, Taoyuan 33303, Taiwan, ROC. Electronic address: itwang@mail.cgust.edu.tw.'}, {'ForeName': 'Nai-Hung', 'Initials': 'NH', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, No. 261, Wunhua 1st Rd., Gueishan Township, Taoyuan 33303, Taiwan, ROC. Electronic address: nhchen@mail.cgust.edu.tw.'}, {'ForeName': 'Chun-Yen', 'Initials': 'CY', 'LastName': 'Chao', 'Affiliation': 'Department of Cosmetic Science, Chang Gung University of Science and Technology, No. 261, Wunhua 1st Rd., Gueishan Township, Taoyuan 33303, Taiwan, ROC. Electronic address: cychao@mail.cgust.edu.tw.'}]",Nurse education today,['10.1016/j.nedt.2019.104231']
3340,31711438,Preprocedural ultrasound versus landmark techniques for spinal anesthesia performed by novice residents in elderly: a randomized controlled trial.,"BACKGROUND


Spinal anesthesia using the midline approach might be technically difficult in geriatric population. We hypothesized that pre-procedural ultrasound (US)-guided paramedian technique and pre-procedural US-guided midline technique would result in a different spinal anesthesia success rate at first attempt when compared with the conventional landmark-guided midline technique in elderly patients.
METHODS


In this prospective, randomized, controlled study, one hundred-eighty consenting patients scheduled for elective surgery were randomized into the conventional surface landmark-guided midline technique (group LM), the pre-procedural US-guided paramedian technique (group UP), or the pre-procedural US-guided midline technique (group UM) with 60 patients in each group. All spinal anesthesia were performed by a novice resident.
RESULTS


The successful dural puncture rate on first attempt (primary outcome) was higher in groups LM and UM (77 and 73% respectively) than in group UP (42%; P < 0.001). The median number of attempts was lower in groups LM and UM (1 [1] and 1 [1-1.75] respectively) than in group UP (2 [1, 2]; P < 0.001). The median number of passes was lower in groups LM and UM (2 [0.25-3] and 2 [0-4]; respectively) than in group UP (4 [2-7.75]; P < 0.001). The time taken to perform the spinal anesthesia was not different between groups LM and UM (87.24 ± 79.51 s and 116.32 ± 98.12 s, respectively) but shorter than in group UP (154.58 ± 91.51 s; P < 0.001).
CONCLUSIONS


A pre-procedural US scan did not improve the ease of midline and paramedian spinal anesthesia as compared to the conventional landmark midline technique when performed by junior residents in elderly population.
TRIAL REGISTRATION


Retrospectively registered at Clinicaltrials.gov, registration number NCT02658058, date of registration: January 18, 2016.",2019,"The median number of attempts was lower in groups LM and UM (1 [1] and 1 [1-1.75] respectively) than in group UP (2 [1, 2]; P < 0.001).","['elderly patients', 'junior residents in elderly population', 'spinal anesthesia performed by novice residents in elderly', 'one hundred-eighty consenting patients scheduled for elective surgery']","['conventional surface landmark-guided midline technique (group LM), the pre-procedural US-guided paramedian technique (group UP), or the pre-procedural US-guided midline technique', 'Preprocedural ultrasound versus landmark techniques', 'pre-procedural ultrasound (US)-guided paramedian technique and pre-procedural US-guided midline technique', 'conventional landmark-guided midline technique']","['time taken to perform the spinal anesthesia', 'successful dural puncture rate', 'ease of midline and paramedian spinal anesthesia', 'median number of attempts', 'median number of passes']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0620576,"The median number of attempts was lower in groups LM and UM (1 [1] and 1 [1-1.75] respectively) than in group UP (2 [1, 2]; P < 0.001).","[{'ForeName': 'Marwan S', 'Initials': 'MS', 'LastName': 'Rizk', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, P.O. Box 11-0236, Beirut, Lebanon.'}, {'ForeName': 'Carine A', 'Initials': 'CA', 'LastName': 'Zeeni', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, P.O. Box 11-0236, Beirut, Lebanon.'}, {'ForeName': 'Joanna N', 'Initials': 'JN', 'LastName': 'Bouez', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, P.O. Box 11-0236, Beirut, Lebanon.'}, {'ForeName': 'Nathalie J', 'Initials': 'NJ', 'LastName': 'Bteich', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, P.O. Box 11-0236, Beirut, Lebanon.'}, {'ForeName': 'Samia K', 'Initials': 'SK', 'LastName': 'Sayyid', 'Affiliation': 'Division of Musculoskeletal Imaging, Emory University Hospital, Atlanta, USA.'}, {'ForeName': 'Waseem S', 'Initials': 'WS', 'LastName': 'Alfahel', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, P.O. Box 11-0236, Beirut, Lebanon.'}, {'ForeName': 'Sahar M', 'Initials': 'SM', 'LastName': 'Siddik-Sayyid', 'Affiliation': 'Department of Anesthesiology, American University of Beirut Medical Center, P.O. Box 11-0236, Beirut, Lebanon. ss01@aub.edu.lb.'}]",BMC anesthesiology,['10.1186/s12871-019-0882-8']
3341,31863046,10 year comparison of glass ionomer and composite resin restoration materials in class 1 and 2 cavities.,"Data sources A prospective randomised, double-blinded controlled trial Study selection Those requiring routine dental care in Sihhiye, Turkey were eligible to participate. Eighty-seven participants were identified and assessed for eligibility by calibrated researchers who ensured that the inclusion and exclusion criteria were met. Fifty-nine participants were successfully recruited with an average age of 24 years (range 15-37).Restoration type were randomly allocated [glass ionomer (GI) or composite resin (CR)] using a table of random numbers with software 'Research Randomised Program' and four experimental groups were created.Two dentists with 5 years experience were calibrated by them placing ten trial restorations , which were not included in the study. One hundred and forty restorations were then placed adhering to a strict treatment protocol. Cavities which did not meet the specifications of the criteria were excluded. The study received ethical approval by the Human Ethics in Clinical Research Committee of the University.Data extraction and synthesis Restorations were assessed at baseline (1 week), 1, 2, 3, 4, 5, 6, 8 and 10 years by blinded calibrated examiners with the aid of colour photographs using an objective criteria. Scanning electron microscopy (SEM) analysis was performed for one randomly selected restoration per group at each assessment. Data analysis adhered to the intention-to-treat CONSORT protocol. The restoration retention rates were calculated, and statistical analysis preformed using IBM SPSS version 22.0. The performance of the restorative materials over the study period were analysed with Cochran's Q test, according to USPHS criteria. Whilst the McNemar test was used to assess aspects of each material with baseline for each cavity type in addition to difference between cavity types. Marginal adaption, marginal discolouration and colour scores in each study group were compared with the p value set at 0.05.Results Eighty-seven patients with 203 lesions were included in the study, with 59 (140 lesions) eligible. Eleven patients were excluded for not meeting the inclusion/ exclusion criteria with 17 refusing to participate. Four randomly allocated groups were created at baseline, as combinations of cavity type and restorative material. 86.4% (n=51) of participants were evaluated after 10 years. The cumulative failure rate (CRF) was 3.17%.Marginal discolouration was observed in all groups at 10 years. With a significant difference observed between Class I and Class II cavities with GI restorations (p = 0.022). In addition, a significant change in colour match in GI restorations after 10 years(<0.005) was found.Over the ten-year period, no significant change was observed in terms of marginal adaption, anatomical form, secondary caries, postoperative sensitivity, surface texture, and retention for either restorative material (p >0.05) or with SEM inspections.Conclusions Both GI and CR are suitable and similar restorative materials for class 1 and class 2 cavities. However, differences can occur in colour change within the materials with glass ionomer restorations showing greater colour change from baseline over this period.",2019,With a significant difference observed between Class I and Class II cavities with GI restorations (p = 0.022).,"['Fifty-nine participants were successfully recruited with an average age of 24 years (range 15-37).Restoration type', 'Eleven patients were excluded for not meeting the inclusion/ exclusion criteria with 17 refusing to participate', '10 year comparison of glass ionomer and composite resin restoration materials in class 1 and 2 cavities', 'One hundred and forty restorations', 'Eighty-seven participants were identified and assessed for eligibility by calibrated researchers who ensured that the inclusion and exclusion criteria were met', '0.05.Results Eighty-seven patients with 203 lesions were included in the study, with 59 (140 lesions) eligible', 'Two dentists with 5 years experience were calibrated by them placing ten trial restorations , which were not included in the study']",['glass ionomer (GI) or composite resin (CR'],"['colour match in GI restorations', 'cumulative failure rate (CRF', 'Marginal adaption, marginal discolouration and colour scores', 'Class I and Class II cavities with GI restorations', 'Data extraction and synthesis Restorations', 'marginal adaption, anatomical form, secondary caries, postoperative sensitivity, surface texture, and retention for either restorative material', 'restoration retention rates']","[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}]","[{'cui': 'C0061297', 'cui_str': 'glass ionomer'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1882989', 'cui_str': 'Secondary caries'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]",87.0,0.0562563,With a significant difference observed between Class I and Class II cavities with GI restorations (p = 0.022).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hutchison', 'Affiliation': 'Glasgow Dental Hospital and School, Glasgow, Scotland, UK. clare.hutchison1@nhs.ne.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cave', 'Affiliation': 'Glasgow Dental Hospital and School, Glasgow, Scotland, UK.'}]",Evidence-based dentistry,['10.1038/s41432-019-0059-9']
3342,31970430,Anterior-stabilized TKA is inferior to posterior-stabilized TKA in terms of postoperative posterior stability and knee flexion in osteoarthritic knees: a prospective randomized controlled trial with bilateral TKA.,"PURPOSE


To determine whether knee stability, range of motion (ROM) and clinical scores differ between anterior-stabilized (AS) and posterior-stabilized (PS) total knee arthroplasty (TKA).
METHODS


This prospective randomized controlled trial included 34 patients with severe bilateral knee osteoarthritis who underwent bilateral TKA between June 2010 and July 2011 using AS and PS designs of a single-implant system. AS TKA with ultracongruent inserts was performed in one knee and PS TKA with a cam-post mechanism was performed in the other knee in each patient. Clinical and radiological data from a mean follow-up period of 5 years, including ROM, clinical scores, peak knee torque determined by isokinetic test, knee joint laxity determined by Telos stress views, tourniquet time and subjects' preference were analyzed.
RESULTS


The mean postoperative knee flexion angle did not differ between groups until 1 year. Beginning 2 years postoperatively, the knee flexion angle decreased slightly in the AS group and was smaller than that in the PS group (p = 0.004). The mean Knee Society knee score was higher in the PS group than in the AS group after 2 years. The quadriceps strength did not differ between groups. The mean posterior laxity after TKA was 6-8 mm greater in the AS group than in the PS group. No radiological loosening was observed in either group. More subjects preferred PS knees to AS knees. However, this difference was not significant.
CONCLUSION


AS primary TKA was inferior to PS TKA in terms of posterior knee stability, postoperative knee flexion and clinical scores after 2 years.
LEVEL OF EVIDENCE


Therapeutic study, Level 1.",2020,The mean posterior laxity after TKA was 6-8 mm greater in the AS group than in the PS group.,"['34 patients with severe bilateral knee osteoarthritis who underwent bilateral TKA between June 2010 and July 2011 using AS and PS designs of a single-implant system', 'osteoarthritic knees']","['Anterior-stabilized TKA', 'anterior-stabilized (AS) and posterior-stabilized (PS) total knee arthroplasty (TKA']","['radiological loosening', 'mean Knee Society knee score', 'knee stability, range of motion (ROM) and clinical scores', ""ROM, clinical scores, peak knee torque determined by isokinetic test, knee joint laxity determined by Telos stress views, tourniquet time and subjects' preference"", 'mean postoperative knee flexion angle', 'mean posterior laxity after TKA', 'knee flexion angle', 'quadriceps strength', 'posterior knee stability, postoperative knee flexion and clinical scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0333050', 'cui_str': 'Loosening (morphologic abnormality)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0574996', 'cui_str': 'Knee joint laxity (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation (observable entity)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}]",34.0,0.0506081,The mean posterior laxity after TKA was 6-8 mm greater in the AS group than in the PS group.,"[{'ForeName': 'Hyuk-Soo', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Seung-Baik', 'Initials': 'SB', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University Boramae Medical Center, 20 Boramae 5th road, Dongjak-Gu, Seoul, 17061, South Korea. ossbkang@gmail.com.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05827-2']
3343,31174846,Cholinergic Modulation of Exposure Disrupts Hippocampal Processes and Augments Extinction: Proof-of-Concept Study With Social Anxiety Disorder.,"BACKGROUND


In rodents, context specificity of Pavlovian extinction is attenuated by manipulations that impair hippocampal function, including systemic administration of scopolamine, a muscarinic-cholinergic receptor antagonist. Context renewal translates into return of fear following exposure therapy to feared situations. We evaluated the effectiveness of scopolamine for attenuating context renewal of phobic fear in humans.
METHODS


A total of 60 participants (35 female, 22 male, 1 transgender, 2 undeclared) with social anxiety disorder and fear of public speaking were randomized to placebo, 0.5 mg scopolamine, or 0.6 mg scopolamine. They completed seven exposure sessions in an exposure context and subsequently tested in the exposure context (extinction retest) versus a different context (context renewal test), which were counterbalanced. Testing 1 month later occurred in the exposure context (long-term extinction retest). Fear measures included skin conductance and self-reported distress during speeches. Hippocampus-dependent cognitive tasks were completed as well.
RESULTS


Scopolamine augmented extinction across exposure sessions on skin conductance response and skin conductance level. Lower skin conductance response at context renewal in scopolamine groups relative to the placebo group was constrained to simple effects and complicated by unexpected outcomes within placebo and on self-reported fear. Scopolamine led to lower skin conductance response at long-term extinction retest. Scopolamine impaired performance on a cognitive task of hippocampal function.
CONCLUSIONS


Noninvasive and well-tolerated scopolamine impaired hippocampal processes and augmented extinction during exposure. Drug-free effects persisted 1 month later. Findings at context renewal were limited and suggestive only. Further investigation is warranted with varying scopolamine dosages.",2019,Lower skin conductance response at context renewal in scopolamine groups relative to the placebo group was constrained to simple effects and complicated by unexpected outcomes within placebo and on self-reported fear.,"['phobic fear in humans', '60 participants (35 female, 22 male, 1 transgender, 2 undeclared) with social anxiety disorder and fear of public speaking']","['placebo, 0.5 mg scopolamine, or 0.6 mg scopolamine', 'placebo', 'Scopolamine', 'scopolamine']","['Lower skin conductance response', 'skin conductance and self-reported distress', 'lower skin conductance response', 'skin conductance response and skin conductance level']","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0558141', 'cui_str': 'Transsexual (finding)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0424169', 'cui_str': 'Fear of public speaking (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",60.0,0.0385867,Lower skin conductance response at context renewal in scopolamine groups relative to the placebo group was constrained to simple effects and complicated by unexpected outcomes within placebo and on self-reported fear.,"[{'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Staglin Center for Brain and Behavioral Health, Department of Psychology, Los Angeles, California; Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California. Electronic address: mcraske@mednet.ucla.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fanselow', 'Affiliation': 'Staglin Center for Brain and Behavioral Health, Department of Psychology, Los Angeles, California; Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Treanor', 'Affiliation': 'Staglin Center for Brain and Behavioral Health, Department of Psychology, Los Angeles, California; Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bystritksy', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California-Los Angeles, Los Angeles, California.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.04.012']
3344,29955161,Effect of intranasal oxytocin on the core social symptoms of autism spectrum disorder: a randomized clinical trial.,"Although small-scale studies have described the effects of oxytocin on social deficits in autism spectrum disorder (ASD), no large-scale study has been conducted. In this randomized, parallel-group, multicenter, placebo-controlled, double-blind trial in Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016. Participants were randomly assigned to a 6-week intranasal oxytocin (48IU/day, n = 53) or placebo (n = 53) group. One-hundred-three participants were analyzed. Since oxytocin reduced the primary endpoint, Autism Diagnostic Observation Schedule (ADOS) reciprocity, (from 8.5 to 7.7; P < .001) but placebo also reduced the score (8.3 to 7.2; P < .001), no between-group difference was found (effect size -0.08; 95% CI, -0.46 to 0.31; P = .69); however, plasma oxytocin was only elevated from baseline to endpoint in the oxytocin-group compared with the placebo-group (effect size -1.12; -1.53 to -0.70; P < .0001). Among the secondary endpoints, oxytocin reduced ADOS repetitive behavior (2.0 to 1.5; P < .0001) compared with placebo (2.0 to 1.8; P = .43) (effect size 0.44; 0.05 to 0.83; P = .026). In addition, the duration of gaze fixation on socially relevant regions, another secondary endpoint, was increased by oxytocin (41.2 to 52.3; P = .03) compared with placebo (45.7 to 40.4; P = .25) (effect size 0.55; 0.10 to 1.0; P = .018). No significant effects were observed for the other secondary endpoints. No significant difference in the prevalence of adverse events was observed between groups, although one participant experienced temporary gynecomastia during oxytocin administration. Based on the present findings, we cannot recommend continuous intranasal oxytocin treatment alone at the current dose and duration for treatment of the core social symptoms of high-functioning ASD in adult men, although this large-scale trial suggests oxytocin's possibility to treat ASD repetitive behavior.",2020,"Among the secondary endpoints, oxytocin reduced ADOS repetitive behavior (2.0 to 1.5; P < .0001) compared with placebo (2.0 to 1.8; P = .43) (effect size 0.44; 0.05 to 0.83; P = .026).","['autism spectrum disorder', 'adult men', 'autism spectrum disorder (ASD', 'One-hundred-three participants were analyzed', 'Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016']","['intranasal oxytocin', 'placebo', 'oxytocin']","['plasma oxytocin', 'prevalence of adverse events', 'temporary gynecomastia', 'duration of gaze fixation', 'oxytocin reduced ADOS repetitive behavior', 'Autism Diagnostic Observation Schedule (ADOS) reciprocity']","[{'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0018418', 'cui_str': 'Male Breast Enlargement'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]",103.0,0.68114,"Among the secondary endpoints, oxytocin reduced ADOS repetitive behavior (2.0 to 1.5; P < .0001) compared with placebo (2.0 to 1.8; P = .43) (effect size 0.44; 0.05 to 0.83; P = .026).","[{'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Yamasue', 'Affiliation': 'Department of Psychiatry, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City, 431-3192, Japan. yamasue@hama-med.ac.jp.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Okada', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Munesue', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Kuroda', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Fujioka', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Eiheiji, Fukui, 910-1193, Japan.'}, {'ForeName': 'Yota', 'Initials': 'Y', 'LastName': 'Uno', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Graduate School of Psychology, Kanazawa Institute of Technology, 7-1 Ohgigaoka, Nonoichi, 921-8054, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Mori', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Eiheiji, Fukui, 910-1193, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Yoshimura', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kawakubo', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Arioka', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kojima', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Teruko', 'Initials': 'T', 'LastName': 'Yuhi', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Keiho', 'Initials': 'K', 'LastName': 'Owada', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Yassin', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Kushima', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Seico', 'Initials': 'S', 'LastName': 'Benner', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Nanayo', 'Initials': 'N', 'LastName': 'Ogawa', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Eriguchi', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kawano', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'Biostatistics Division, Clinical Research Support Center, University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Maeri', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Kano', 'Affiliation': 'Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Kiyoto', 'Initials': 'K', 'LastName': 'Kasai', 'Affiliation': 'Department of Neuropsychiatry, School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.'}, {'ForeName': 'Haruhiro', 'Initials': 'H', 'LastName': 'Higashida', 'Affiliation': 'Research Center for Child Mental Development, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8640, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ozaki', 'Affiliation': 'Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Kosaka', 'Affiliation': 'Research Center for Child Mental Development, University of Fukui, Eiheiji, Fukui, 910-1193, Japan.'}]",Molecular psychiatry,['10.1038/s41380-018-0097-2']
3345,31078355,Application of High-Frequency Transcutaneous Electrical Nerve Stimulation in Muscle Tension Dysphonia Patients With the Pain Complaint: The Immediate Effect.,"INTRODUCTION


The aim of the present study was to investigate the immediate effect of the application of high-frequency Transcutaneous electrical nerve stimulation (TENS) in muscle tension dysphonia (MTD) patients with the pain complaint.
MATERIALS AND METHODS


Thirty patients with MTD, 10 men and 20 women with a mean age of 36.40 ± 5.76 years, participated in the study. The patients were randomized into two groups: (1) Treatment group (TENS) (10 women and 5 men) and (2) Sham TENS group (10 women and 5 men). The treatment group (TENS) received a unique 20-minute session of high-frequency TENS. The sham TENS group was treated in the same condition as the treatment group and received a unique 20-minute session of high-frequency TENS, but no stimulation was given. Auditory-perceptual assessments, acoustic voice analysis, vocal tract discomfort (VTD), and musculoskeletal pain were used to compare the patients pre- and post-treatment.
RESULTS


There was a significant improvement in the asthenia parameter of auditory-perceptual assessment in the TENS group. This improvement in asthenia was significant when comparing the TENS group with the sham TENS group. These differences in the asthenia were not significant after using Holm-Bonferroni correction. A comparison of the VTD before and after the TENS application showed there was a significant reduction in the severity of the symptoms (burning, tight, dry, pain, tickling, sore, irritable, and lump in the throat). When comparing the TENS group with the sham TENS group, improvements in burn, tight, dry, pain, and irritable items of VTD were observed. However, after applying the Holm-Bonferroni correction, only reductions in dry and pain items remain significantly different between the groups. After the TENS application, the pain intensity was significantly reduced in the anterior and posterior neck, larynx, submandibular, masseter, temporal region, and upper back. After applying the Holm-Bonferroni correction, pain intensity reduction was significant in the anterior neck and larynx. When comparing the TENS group with the sham TENS group, pain intensity was reduced significantly in the larynx of the TENS group. This difference between the two groups was not significant after using Holm-Bonferroni correction. The pain and VTD assessments in the present study were performed using valid and reliable self-reported scales (NMSQ-E and VTD).
CONCLUSION


High-frequency TENS can be used in the voice treatment program of patients with MTD. MTD patients with pain complaint reported that their vocal tract discomfort and pain were decreased following the high-frequency TENS. Notably, these positive effects were obtained after a single session of high-frequency TENS application.",2020,"After the TENS application, the pain intensity was significantly reduced in the anterior and posterior neck, larynx, submandibular, masseter, temporal region, and upper back.","['patients with MTD', 'MTD patients with pain complaint', 'Muscle Tension Dysphonia Patients With the Pain Complaint', 'group (10 women and 5 men', 'muscle tension dysphonia (MTD) patients with the pain complaint', 'Thirty patients with MTD, 10 men and 20 women with a mean age of 36.40 ± 5.76 years, participated in the study']","['unique 20-minute session of high-frequency TENS', 'TENS', 'Treatment group (TENS', 'Sham TENS', 'high-frequency Transcutaneous electrical nerve stimulation (TENS', 'High-Frequency Transcutaneous Electrical Nerve Stimulation']","['vocal tract discomfort and pain', 'dry and pain items', 'Auditory-perceptual assessments, acoustic voice analysis, vocal tract discomfort (VTD), and musculoskeletal pain', 'pain and VTD assessments', 'asthenia', 'severity of the symptoms (burning, tight, dry, pain, tickling, sore, irritable, and lump in the throat', 'pain intensity', 'asthenia parameter of auditory-perceptual assessment', 'pain intensity reduction', 'burn, tight, dry, pain, and irritable items of VTD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0427195', 'cui_str': 'Muscle tension (finding)'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0453911', 'cui_str': 'Tights (physical object)'}, {'cui': 'C0234201', 'cui_str': 'Tickling sensation quality'}, {'cui': 'C1455785', 'cui_str': 'Sore sensation quality'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0577559', 'cui_str': 'Mass'}, {'cui': 'C0230069', 'cui_str': 'Structure of anterior portion of neck'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",30.0,0.0280211,"After the TENS application, the pain intensity was significantly reduced in the anterior and posterior neck, larynx, submandibular, masseter, temporal region, and upper back.","[{'ForeName': 'Banafshe', 'Initials': 'B', 'LastName': 'Mansuri', 'Affiliation': 'Department of Speech and Language Pathology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Torabinezhad', 'Affiliation': 'Department of Speech and Language Pathology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran. Electronic address: torabinezhad.f@iums.ac.ir.'}, {'ForeName': 'Ali Ashraf', 'Initials': 'AA', 'LastName': 'Jamshidi', 'Affiliation': 'Department of Physical Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Payman', 'Initials': 'P', 'LastName': 'Dabirmoghadam', 'Affiliation': 'Otolaryngology Research Center, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Behnoosh', 'Initials': 'B', 'LastName': 'Vasaghi-Gharamaleki', 'Affiliation': 'Department of Basic Sciences in Rehabilitation, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ghelichi', 'Affiliation': 'Department of Speech and Language Pathology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2019.02.009']
3346,31888691,A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial.,"BACKGROUND


In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1D. FOH also results in increased glycemic variability (GV). A major gap exists in how to manage FOH. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and GV in young adults with T1D to reduce or delay diabetes complications and improve quality of life. We aim to (1) determine the feasibility and acceptability of an eight-week cognitive behavioral therapy (CBT)-based Fear Reduction Efficacy Evaluation (FREE) intervention in young adults with T1D who experience FOH; and (2) determine the impact of the FREE intervention, compared to an attention control group, on the outcomes FOH, self-management, glycemic control (A1C), and glycemic variability (continuous glucose monitoring recordings).
METHODS/DESIGN


A randomized controlled trial in 50 young adults aged 18 to 35 years with T1D will be used. Eligible subjects will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior, A1C, and real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE program. The attention control group will participate in eight weekly individual one-hour diabetes self-management education (DSME) sessions and wear a RT-CGM device (to measure GV only) over 8 weeks. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine differences between the FREE and control groups.
DISCUSSION


Findings from this proposed pilot study will serve as the foundation for a larger trial to reduce FOH and improve self-management, glycemic control, and GV.
TRIAL REGISTRATION


ClinicalTrials.gov: A cognitive behavioral therapy (CBT) intervention to reduce fear of hypoglycemia in type 1 diabetes, NCT03549104. Registered June 7, 2018.",2019,Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1D. FOH also results in increased glycemic variability (GV).,"['young adults with type 1 diabetes (FREE', 'young adults with T1D', 'young adults with T1D who experience FOH', 'Young adults with T1D', 'persons with type 1 diabetes (T1D', 'Eligible subjects', '50 young adults aged 18 to 35\u2009years with T1D will be used']","['individual one-hour diabetes self-management education (DSME) sessions and wear a RT-CGM device', 'eight-week cognitive behavioral therapy (CBT)-based Fear Reduction Efficacy Evaluation (FREE) intervention', 'RT-CGM', 'cognitive behavioral therapy intervention', 'intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group', 'cognitive behavioral therapy (CBT) intervention', 'FREE intervention']","['hypoglycemia (blood glucose level', 'glycemic variability (GV', 'quality of life', 'fear of hypoglycemia', 'glycemic control and self-management behavior', 'feasibility and acceptability', 'outcomes FOH, self-management, glycemic control (A1C), and glycemic variability (continuous glucose monitoring recordings']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0034380'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]",50.0,0.0231074,Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1D. FOH also results in increased glycemic variability (GV).,"[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Martyn-Nemeth', 'Affiliation': 'Department of Biobehavioral Health Science, University of Illinois at Chicago College of Nursing, 845 South Damen Avenue (MC 802), Chicago, IL, 60612, USA. pmartyn@uic.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Duffecy', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Quinn', 'Affiliation': 'Department of Biobehavioral Health Science, University of Illinois at Chicago College of Nursing, 845 South Damen Avenue (MC 802), Chicago, IL, 60612, USA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Health Systems Science, University of Illinois at Chicago College of Nursing, Chicago, IL, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Mihailescu', 'Affiliation': 'Endocrinology/Diabetes and Metabolism, Department of Medicine, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Penckofer', 'Affiliation': 'Loyola University Chicago, Chicago, IL, USA.'}]",Trials,['10.1186/s13063-019-3876-4']
3347,31888726,Teacher Anxiety Program for Elementary Students (TAPES): intervention development and proposed randomized controlled trial.,"BACKGROUND


Excessive student anxiety is a common problem that severely impairs short- and long-term academic functioning and increases teacher burden. Reducing student anxiety has been associated with improvement in educational functioning. Because anxiety manifests daily in the classroom, teachers are in an ideal position to identify and help students manage their anxiety. Unfortunately, teachers lack the knowledge and skills to support the learning of students with excessive anxiety. The Teacher Anxiety Program for Elementary Students (TAPES), a novel teacher-administered school-home collaborative intervention, was designed to address this gap.
METHODS


This manuscript describes the protocol for developing and evaluating TAPES. Specifically, we present a description of: (1) the intervention and theoretical model; and (2) methods for the proposed randomized controlled trial comparing TAPES to a standard professional development seminar focused on reducing student anxiety.
DISCUSSION


Primary aims examine the impact of the TAPES training on teacher knowledge and skill. Secondary aims examine the impact of TAPES on student outcomes. Exploratory aims will examine mediators based on our proposed theory of change. If effective, TAPES has the potential to directly benefit teachers (improving skills) and students (reducing anxiety and improving functioning).
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03899948. Registered on 28 March 2019.",2019,"If effective, TAPES has the potential to directly benefit teachers (improving skills) and students (reducing anxiety and improving functioning).
",['Elementary Students (TAPES'],"['TAPES training', 'TAPES', 'Teacher Anxiety Program for Elementary Students (TAPES), a novel teacher-administered school-home collaborative intervention']",['teacher knowledge and skill'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}]","[{'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0888685,"If effective, TAPES has the potential to directly benefit teachers (improving skills) and students (reducing anxiety and improving functioning).
","[{'ForeName': 'Golda S', 'Initials': 'GS', 'LastName': 'Ginsburg', 'Affiliation': 'University of Connecticut School of Medicine, 65 Kane Street Room 2033, West Hartford, CT, 06119, USA. gginsburg@uchc.edu.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Pella', 'Affiliation': 'University of Connecticut School of Medicine, 65 Kane Street Room 2033, West Hartford, CT, 06119, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Piselli', 'Affiliation': 'University of Connecticut School of Medicine, 65 Kane Street Room 2033, West Hartford, CT, 06119, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'University of Connecticut School of Medicine, 65 Kane Street Room 2033, West Hartford, CT, 06119, USA.'}]",Trials,['10.1186/s13063-019-3863-9']
3348,31769496,Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials.,"CONTEXT


Variations in the prevalence and etiology of type 2 diabetes (T2D) across race and ethnicity may affect treatment responses. Semaglutide is a glucagon-like peptide-1 analog approved for once-weekly, subcutaneous treatment of T2D.
OBJECTIVE


To compare semaglutide efficacy and safety in race and ethnicity subgroups across the SUSTAIN trials.
DESIGN


Post hoc analysis of data from phase 3 randomized SUSTAIN 1-5 and 7 (pooled), and SUSTAIN 6 trials.
PARTICIPANTS


3074 subjects (SUSTAIN 1-5 and 7) and 1648 subjects (SUSTAIN 6).
INTERVENTIONS


Semaglutide 0.5 or 1.0 mg, placebo, or active comparator (sitagliptin 100 mg, exenatide extended release 2.0 mg, insulin glargine 100IU/ml and dulaglutide 0.75 or 1.5 mg).
MAIN OUTCOME MEASURES


Change in hemoglobin A1C (HbA1c) and body weight from baseline to weeks 30, 40 and 104, and other efficacy and safety endpoints.
RESULTS


HbA1c was reduced from baseline by 1.0 to 1.5 percentage points and 1.3 to 2.0 percentage points, and body weight was reduced by 2.3 to 4.7 kg and 3.6 to 6.1 kg with semaglutide 0.5 and 1.0 mg, respectively, across race and ethnicity subgroups. Minor changes in blood pressure and lipid profiles were observed. Adverse events (AEs) were reported in similar proportions of subjects across trials. More Asian versus other race subgroups discontinued treatment prematurely due to AEs. The most commonly reported AEs were gastrointestinal disorders.
CONCLUSIONS


In this SUSTAIN trials post hoc analysis, semaglutide was associated with consistent and clinically relevant reductions in HbA1c and body weight in subjects with T2D, with minor variations in efficacy and safety outcomes associated with race or ethnicity.",2020,Semaglutide is a glucagon-like peptide-1,"['3,074 subjects (SUSTAIN 1-5 and 7); 1,648 subjects (SUSTAIN 6', 'type 2 diabetes by race and ethnicity']","['exenatide extended release 2.0 mg, insulin glargine 100IU/ml and dulaglutide 0.75 or 1.5 mg', 'semaglutide', 'Semaglutide 0.5 or 1.0 mg, placebo or active comparator (sitagliptin']","['blood pressure and lipid profiles', 'Adverse events (AEs', 'body weight', 'Change in HbA1c and body weight', 'Efficacy and safety', 'efficacy and safety endpoints']","[{'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1648.0,0.224434,Semaglutide is a glucagon-like peptide-1,"[{'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'DeSouza', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, US.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cariou', 'Affiliation': ""L'Institut du Thorax, Department of Endocrinology, CHU Nantes, Nantes, France.""}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Denver, Denver, CO, US.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Lausvig', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Navarria', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Fonseca', 'Affiliation': 'Tulane University Health Sciences Center, New Orleans, LA, US.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz072']
3349,31906801,Effects of Balance Training on Balance Performance in Youth: Are There Age Differences?,"Purpose : In youth, cross-sectional studies reported age differences in balance performance that were in favor of adolescents. Thus, trainability of balance performance might be different in children compared to adolescents. The purpose of this study was therefore to compare the effects of balance training (BT) on balance performance between children and adolescents. Method : Thirty children (7.5 ± 0.5 years) and 42 adolescents (14.7 ± 0.5 years) participated in this study and were assigned to either a BT-group or a control (CON) group. In both age groups, BT was conducted over five weeks while the CON-groups received their regular physical education lessons. Pre- and posttests included the assessment of mobility, static steady-state, proactive, and reactive balance. Results : Significant Test × Group × Age interactions were found for static steady-state balance (i.e., CoP displacements during single leg stance) and mobility (i.e., 10-m gait velocity). For both measures, post hoc analysis revealed larger improvements (+16-37%, 0.001 ≤  p  ≤ 0.033, 0.65 ≤  d  ≤ 2.24) for children compared to adolescents. For proxies of proactive and reactive balance, we could not detect significant Test × Group × Age interactions. Conclusions : We conclude that trainability of static steady-state balance and mobility seems to be higher in children than in adolescents indicating larger adaptive reserves in children compared to adolescents. However, there were no age differences in adaptations to BT with respect to proactive and reactive balance.",2020,"For both measures, post hoc analysis revealed larger improvements (+16-37%, 0.001 ≤  p  ≤ 0.033, 0.65 ≤  d  ≤ 2.24) for children compared to adolescents.","['Youth', 'Thirty children (7.5\xa0±\xa00.5\xa0years) and 42 adolescents (14.7\xa0±\xa00.5\xa0years', 'children and adolescents']","['Balance Training', 'balance training (BT', 'CON-groups received their regular physical education lessons', 'BT-group or a control (CON']","['assessment of mobility, static steady-state, proactive, and reactive balance', 'balance performance', 'static steady-state balance (i.e., CoP displacements', 'Balance Performance']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2317515', 'cui_str': 'Assessment of mobility (procedure)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}]",30.0,0.0210385,"For both measures, post hoc analysis revealed larger improvements (+16-37%, 0.001 ≤  p  ≤ 0.033, 0.65 ≤  d  ≤ 2.24) for children compared to adolescents.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Schedler', 'Affiliation': 'University of Duisburg-Essen.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Brock', 'Affiliation': 'University of Duisburg-Essen.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Fleischhauer', 'Affiliation': 'University of Duisburg-Essen.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Kiss', 'Affiliation': 'FHM Bielefeld - University of Applied Sciences.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Muehlbauer', 'Affiliation': 'University of Duisburg-Essen.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1676371']
3350,31947205,Comparison of Visual and Auditory Modalities for Upper-Alpha EEG-Neurofeedback .,"Electroencephalography (EEG) neurofeedback (NF) training has been shown to produce long-lasting effects on the improvement of cognitive function as well as the normalization of aberrant brain activity in disease. However, the impact of the sensory modality used as the NF reinforcement signal on training effectiveness has not been systematically investigated. In this work, an EEG-based NF-training system was developed targeting the individual upper-alpha (UA) band and using either a visual or an auditory reinforcement signal, so as to compare the effects of the two sensory modalities. Sixteen healthy volunteers were randomly assigned to the Visual or Auditory group, where a radius-varying sphere or a volume-varying sound, respectively, reflected the relative amplitude of UA measured at EEG electrode Cz. Each participant underwent a total of four NF sessions, of approximately 40 min each, on consecutive days. Both groups showed significant increases in UA at Cz within sessions, and also across sessions. Effects subsequent to NF training were also found beyond the target frequency UA and scalp location Cz, namely in the lower-alpha and theta bands and in posterior brain regions, respectively. Only small differences were found on the EEG between the Visual and Auditory groups, suggesting that auditory reinforcement signals may be as effective as the more commonly used visual signals. The use of auditory NF may potentiate training protocols conducted under mobile conditions, which are now possible due to the increasing availability of wireless EEG systems.",2019,"Effects subsequent to NF training were also found beyond the target frequency UA and scalp location Cz, namely in the lower-alpha and theta bands and in posterior brain regions, respectively.",['Sixteen healthy volunteers'],"['Electroencephalography (EEG) neurofeedback (NF) training', 'NF training']","['UA', 'target frequency UA and scalp location Cz']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}]",16.0,0.0188559,"Effects subsequent to NF training were also found beyond the target frequency UA and scalp location Cz, namely in the lower-alpha and theta bands and in posterior brain regions, respectively.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Bucho', 'Affiliation': ''}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Caetano', 'Affiliation': ''}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Vourvopoulos', 'Affiliation': ''}, {'ForeName': 'Floriana', 'Initials': 'F', 'LastName': 'Accoto', 'Affiliation': ''}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Esteves', 'Affiliation': ''}, {'ForeName': 'Sergi Bermudez', 'Initials': 'SB', 'LastName': 'I Badia', 'Affiliation': ''}, {'ForeName': 'Agostinho', 'Initials': 'A', 'LastName': 'Rosa', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Figueiredo', 'Affiliation': ''}]",Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference,['10.1109/EMBC.2019.8856671']